,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32379581,Ultrasound-guided platelet-rich plasma injection for the treatment of recalcitrant rotator cuff disease in wheelchair users with spinal cord injury: A pilot study.,"Context/Objective:  Wheelchair users with spinal cord injury (SCI) have a high risk of developing shoulder pain, caused by rotator cuff disease. Platelet-rich plasma (PRP) is a potential treatment after conservative treatments fail and prior to surgical intervention; however, it has not been tested in wheelchair users who have recalcitrant shoulder pain associated with rotator cuff disease. The objective of this pilot project was to test the safety and potential treatment effect of an ultrasound-guided PRP injection for shoulder pain in the aforementioned population. Design:  Prospective, quasi-experimental. Setting:  Clinical research center. Participants:  Six wheelchair users with SCI (3 paraplegia, 3 tetraplegia) who had chronic shoulder pain due to rotator cuff disease (presence of anterior shoulder pain, positive physical examination tests for rotator cuff disease, and tendinopathy demonstrated by ultrasound) and failed at least six months of conservative treatment. Interventions:  Ultrasound-guided PRP injection into pathological shoulder tendons, targeting the supraspinatus. Subjects were provided a standardized stretching and strengthening program and were followed for 4, 8, 12, and 24 weeks post-intervention with outcomes collected at each time-point. Outcome Measures:  Wheelchair User's Shoulder Pain Index (WUSPI); pain Numerical Rating Scale (NRS); physical and ultrasound examinations for supraspinatus tendinopathy; 5-point patient global impression of change (PGIC). Results:  WUSPI (69.9%, P < 0.001), NRS (49.6%, P < 0.01), and physical exam scores (35.7%, P < 0.01) decreased 24 weeks after treatment. Participants reported overall improvement in their status as a result of the treatment. No adverse events were noted, and no changes in ultrasound markers for tendinopathy were observed. Conclusion:  A single, ultrasound-guided PRP injection into the supraspinatus tendon, followed by a stretching and strengthening exercise program, was safe and provided improvements in shoulder pain outcome measures in this sample for 24 weeks. Lack of blinding, short-term follow-up, and a suitable control group warrant a larger randomized controlled trial. Trial Registration:  NCT01355549.",2022,"Results:  WUSPI (69.9%, P < 0.001), NRS (49.6%, P < 0.01), and physical exam scores (35.7%, P < 0.01) decreased 24 weeks after treatment.","['wheelchair users who have recalcitrant shoulder pain associated with rotator cuff disease', 'Wheelchair users with spinal cord injury (SCI', 'Six wheelchair users with SCI (3 paraplegia, 3 tetraplegia) who had chronic shoulder pain due to rotator cuff disease (presence of anterior shoulder pain, positive physical examination tests for rotator cuff disease, and tendinopathy demonstrated by ultrasound) and failed at least six months of conservative treatment', 'wheelchair users with spinal cord injury', 'Participants']","['Ultrasound-guided platelet-rich plasma injection', 'Platelet-rich plasma (PRP', 'ultrasound-guided PRP injection', 'stretching and strengthening exercise program', 'standardized stretching and strengthening program', 'Ultrasound-guided PRP injection']","['NRS', 'adverse events', 'ultrasound markers for tendinopathy', ""Outcome Measures:  Wheelchair User's Shoulder Pain Index (WUSPI); pain Numerical Rating Scale (NRS); physical and ultrasound examinations for supraspinatus tendinopathy; 5-point patient global impression of change (PGIC"", 'physical exam scores']","[{'cui': 'C0853966', 'cui_str': 'Wheelchair user'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030486', 'cui_str': 'Paraplegia'}, {'cui': 'C0034372', 'cui_str': 'Tetraplegia'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0853966', 'cui_str': 'Wheelchair user'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.064088,"Results:  WUSPI (69.9%, P < 0.001), NRS (49.6%, P < 0.01), and physical exam scores (35.7%, P < 0.01) decreased 24 weeks after treatment.","[{'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Dyson-Hudson', 'Affiliation': 'Kessler Foundation, West Orange, New Jersey, USA.'}, {'ForeName': 'Nathan S', 'Initials': 'NS', 'LastName': 'Hogaboom', 'Affiliation': 'Kessler Foundation, West Orange, New Jersey, USA.'}, {'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School, Newark, New Jersey, USA.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Terry', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School, Newark, New Jersey, USA.'}, {'ForeName': 'Gerard A', 'Initials': 'GA', 'LastName': 'Malanga', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School, Newark, New Jersey, USA.'}]",The journal of spinal cord medicine,['10.1080/10790268.2020.1754676']
1,32362229,Effect of Intensive Blood Pressure Lowering on the Risk of Atrial Fibrillation.,"It remains uncertain whether intensive control of blood pressure (BP) results in a lower risk of atrial fibrillation (AF) in patients with hypertension. Using data from SPRINT (Systolic Blood Pressure Intervention Trial), which enrolled participants with hypertension at increased risk of cardiovascular disease, we examined whether intensive BP lowering (target systolic BP [SBP] <120 mm Hg), compared with standard BP lowering (target SBP<140 mm Hg), results in a lower risk of AF. This analysis included 8022 participants (4003 randomized to the intensive arm and 4019 to standard BP arm) who were free of AF at the time of enrollment and with available baseline and follow-up electrocardiographic data. AF was ascertained from standard 12-lead electrocardiograms recorded at biannual study examinations and an exit visit. During up to 5.2 years of follow-up and a total of 28 322 person-years, 206 incident AF cases occurred; 88 in the intensive BP-lowering arm and 118 in the standard BP-lowering arm. Intensive BP lowering was associated with a 26% lower risk of developing new AF (hazard ratio, 0.74 [95% CI, 0.56-0.98];  P =0.037). This effect was consistent among prespecified subgroups of SPRINT participants stratified by age, sex, race, SBP tertiles, prior cardiovascular disease, and prior chronic kidney disease when interactions between treatment effect and these subgroups were assessed using Hommel adjusted  P  values. In conclusion, intensive treatment to a target of SBP <120 mm Hg in patients with hypertension at high risk of cardiovascular disease has the potential to reduce the risk of AF. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT01206062.",2020,"Intensive BP lowering was associated with a 26% lower risk of developing new AF (hazard ratio, 0.74 [95% CI, 0.56-0.98];  P =0.037).","['enrolled participants with hypertension at increased risk of cardiovascular disease', 'patients with hypertension', '8022 participants (4003 randomized to the intensive arm and 4019 to standard BP arm) who were free of AF at the time of enrollment and with available baseline and follow-up electrocardiographic data', 'patients with hypertension at high risk of cardiovascular disease']","['Intensive Blood Pressure Lowering', 'SBP']","['intensive BP lowering (target systolic BP [SBP', 'Intensive BP lowering', 'Risk of Atrial Fibrillation', 'blood pressure (BP']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1277632', 'cui_str': 'Target systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",,0.199646,"Intensive BP lowering was associated with a 26% lower risk of developing new AF (hazard ratio, 0.74 [95% CI, 0.56-0.98];  P =0.037).","[{'ForeName': 'Elsayed Z', 'Initials': 'EZ', 'LastName': 'Soliman', 'Affiliation': 'From the Epidemiological Cardiology Research Center, Department of Epidemiology and Prevention, Division of Public Health Sciences and Department of Medicine, Section on Cardiology, Wake Forest School of Medicine, Winston-Salem, NC (E.Z.S.).'}, {'ForeName': 'Akm F', 'Initials': 'AF', 'LastName': 'Rahman', 'Affiliation': 'Department of Biostatistics (A.F.R.), University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Zhu-Ming', 'Initials': 'ZM', 'LastName': 'Zhang', 'Affiliation': 'Epidemiological Cardiology Research Center (EPICARE), Department of Epidemiology and Prevention, Division of Public Health Sciences (Z-M.Z.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Carlos J', 'Initials': 'CJ', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Medicine/Cardiology, Albert Einstein College of Medicine, Bronx, NY (C.J.R.).'}, {'ForeName': 'Tara I', 'Initials': 'TI', 'LastName': 'Chang', 'Affiliation': 'Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA (T.I.C.).'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Bates', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX (J.T.B.).'}, {'ForeName': 'Lama', 'Initials': 'L', 'LastName': 'Ghazi', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN (L.G.).'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Blackshear', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic Florida, Jacksonville, FL (J.L.B.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, CO (M.C.).'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Fine', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD (L.J.F.).'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences (W.T.A.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology, and Department of Medicine (C.E.L.), University of Alabama at Birmingham, Birmingham, AL.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.14766']
2,32359899,Influence of lipoproteins and antiplatelet agents on vein graft patency 1 year after coronary artery bypass grafting.,"OBJECTIVE


It remains unclear whether aggressive low-density lipoprotein cholesterol (LDL-C) management (<1.8 mmol/L) can slow the process of vein graft stenosis. This study aimed to explore the impact of baseline LDL-C levels on vein graft patency in patients on ticagrelor with or without aspirin 1 year after coronary artery bypass grafting (CABG).
METHODS


This was a post hoc analysis of the DACAB (Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery) trial (NCT02201771), a randomized controlled trial (ticagrelor + aspirin or ticagrelor vs aspirin) of patients undergoing CABG in China. The study subjects were stratified as LDL-low (baseline LDL-C <1.8 mmol/L, 148 patients with 430 vein grafts) versus LDL-high (baseline LDL-C ≥1.8 mmol/L, 352 patients with 1030 vein grafts). The primary outcome was the 1-year vein graft patency (Fitzgibbon grade A) assessed by coronary computed tomographic angiography or coronary angiography.
RESULTS


Baseline/1-year LDL-C were 1.4/1.6 and 2.6/2.4 mmol/L in the LDL-low and LDL-high subgroups, respectively. Regardless of antiplatelet regimen, no significant inter-subgroup difference was observed for 1-year graft patency (LDL-low: 83.8% [359/430 grafts]; LDL-high: 82.3% [848/1030 grafts]; adjusted OR for non-patency [OR adj ], 0.96; 95% confidence interval [CI], 0.62-1.50, P = .857). For both subgroups, the 1-year graft patency rates were greater with ticagrelor + aspirin versus aspirin (LDL-low: OR adj , 0.41; 95% CI, 0.17-0.97; LDL-high: OR adj , 0.38; 95% CI, 0.20-0.71; inter P = .679).
CONCLUSIONS


In general, baseline LDL-C is not associated with 1-year vein graft patency after CABG. Regardless of the baseline LDL-C levels, ticagrelor + aspirin was superior to aspirin alone in maintaining vein graft patency. The primary factor causing early vein graft disease might not be atherosclerosis but thrombosis.",2022,"Regardless of the baseline LDL-C levels, ticagrelor + aspirin was superior to aspirin alone in maintaining vein graft patency.","['148 patients with 430 vein grafts) versus LDL-high (baseline LDL-C ≥1.8\xa0mmol/L, 352 patients with 1030 vein grafts', 'patients undergoing CABG in China', 'vein graft patency 1\xa0year after coronary artery bypass grafting', 'patients on ticagrelor with or without aspirin 1\xa0year after coronary artery bypass grafting (CABG']","['ticagrelor\xa0+\xa0aspirin or ticagrelor vs aspirin', 'lipoproteins and antiplatelet agents', 'aspirin', 'ticagrelor\xa0+\xa0aspirin']","['1-year graft patency rates', 'aggressive low-density lipoprotein cholesterol (LDL-C) management', '1-year vein graft patency', '1-year vein graft patency (Fitzgibbon grade A) assessed by coronary computed tomographic angiography or coronary angiography', '1-year graft patency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet agent'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]",148.0,0.186856,"Regardless of the baseline LDL-C levels, ticagrelor + aspirin was superior to aspirin alone in maintaining vein graft patency.","[{'ForeName': 'Jiaxi', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiovascular Surgery, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiovascular Surgery, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Minlu', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Cancer Control and Prevention, Shanghai Municipal Center for Disease Control and Prevention, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiovascular Surgery, Changhai Hospital of Shanghai, Shanghai, China.'}, {'ForeName': 'Junlong', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiovascular Surgery, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiothoracic Surgery, Xinhua Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, Nanjing First Hospital, Nanjing, China.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiovascular Surgery, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China. Electronic address: zq11607@rjh.com.cn.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.03.039']
3,32386395,Δ 9 -Tetrahydrocannabinol (THC) impairs visual working memory performance: a randomized crossover trial.,"With the increasing prevalence of legal cannabis use and availability, there is an urgent need to identify cognitive impairments related to its use. It is widely believed that cannabis, or its main psychoactive component Δ 9 -tetrahydrocannabinol (THC), impairs working memory, i.e., the ability to temporarily hold information in mind. However, our review of the literature yielded surprisingly little empirical support for an effect of THC or cannabis on working memory. We thus conducted a study with three main goals: (1) quantify the effect of THC on visual working memory in a well-powered sample, (2) test the potential role of cognitive effects (mind wandering and metacognition) in disrupting working memory, and (3) demonstrate how insufficient sample size and task duration reduce the likelihood of detecting a drug effect. We conducted two double-blind, randomized crossover experiments in which healthy adults (N = 23, 23) performed a reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC (7.5 and/or 15 mg oral) or placebo. We also assessed self-reported ""mind wandering"" (Exp 1) and metacognitive accuracy about ongoing task performance (Exp 2). THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2). Thus, our findings indicate that THC does impair visual working memory, and that this impairment may be related to both increased mind wandering and decreased monitoring of task performance. Finally, we used a down-sampling procedure to illustrate the effects of task length and sample size on power to detect the acute effect of THC on working memory.",2020,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","['healthy adults (N\u2009=\u200923, 23) performed a']","['THC', 'reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC', 'placebo', 'Tetrahydrocannabinol (THC']","['metacognitive accuracy about task performance', 'THC impaired working memory performance', 'visual working memory', 'visual working memory performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.14689,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","[{'ForeName': 'Kirsten C S', 'Initials': 'KCS', 'LastName': 'Adam', 'Affiliation': 'Department of Psychology, University of California San Diego, San Diego, CA, USA. kadam@ucsd.edu.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Doss', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pabon', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Vogel', 'Affiliation': 'Grossman Institute for Neuroscience, Quantitative Biology, and Human Behavior, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0690-3']
4,32352165,Aspirin and other non-steroidal anti-inflammatory drugs for the prevention of dementia.,"BACKGROUND


Dementia is a worldwide concern. Its global prevalence is increasing. At present, there is no medication licensed to prevent or delay the onset of dementia. Inflammation has been suggested as a key factor in dementia pathogenesis. Therefore, medications with anti-inflammatory properties could be beneficial for dementia prevention.
OBJECTIVES


To evaluate the effectiveness and adverse effects of aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) for the primary or secondary prevention of dementia.
SEARCH METHODS


We searched ALOIS, the specialised register of the Cochrane Dementia and Cognitive Improvement Group up to 9 January 2020. ALOIS contains records of clinical trials identified from monthly searches of several major healthcare databases, trial registries and grey literature sources. We ran additional searches across MEDLINE (OvidSP), Embase (OvidSP) and six other databases to ensure that the searches were as comprehensive and up-to-date as possible. We also reviewed citations of reference lists of included studies.
SELECTION CRITERIA


We searched for randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing aspirin or other NSAIDs with placebo for the primary or secondary prevention of dementia. We included trials with cognitively healthy participants (primary prevention) or participants with mild cognitive impairment (MCI) or cognitive complaints (secondary prevention).
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the strength of evidence for each outcome using the GRADE approach.
MAIN RESULTS


We included four RCTs with 23,187 participants. Because of the diversity of these trials, we did not combine data to give summary estimates, but presented a narrative description of the evidence. We identified one trial (19,114 participants) comparing low-dose aspirin (100 mg once daily) to placebo. Participants were aged 70 years or older with no history of dementia, cardiovascular disease or physical disability. Interim analysis indicated no significant treatment effect and the trial was terminated slightly early after a median of 4.7 years' follow-up. There was no evidence of a difference in incidence of dementia between aspirin and placebo groups (risk ratio (RR) 0.98, 95% CI 0.83 to 1.15; high-certainty evidence). Participants allocated aspirin had higher rates of major bleeding (RR 1.37, 95% CI 1.17 to 1.60, high-certainty evidence) and slightly higher mortality (RR 1.14, 95% CI 1.01 to 1.28; high-certainty evidence). There was no evidence of a difference in activities of daily living between groups (RR 0.84, 95% CI 0.70 to 1.02; high-certainty evidence). We identified three trials comparing non-aspirin NSAIDs to placebo. All three trials were terminated early due to adverse events associated with NSAIDs reported in other trials. One trial (2528 participants) investigated the cyclo-oxygenase-2 (COX-2) inhibitor celecoxib (200 mg twice daily) and the non-selective NSAID naproxen (220 mg twice daily) for preventing dementia in cognitively healthy older adults with a family history of Alzheimer's disease (AD). Median follow-up was 734 days. Combining both NSAID treatment arms, there was no evidence of a difference in the incidence of AD between participants allocated NSAIDs and those allocated placebo (RR 1.91, 95% CI 0.89 to 4.10; moderate-certainty evidence). There was also no evidence of a difference in rates of myocardial infarction (RR 1.21, 95% CI 0.61 to 2.40), stroke (RR 1.82, 95% CI 0.76 to 4.37) or mortality (RR 1.37, 95% CI 0.78 to 2.43) between treatment groups (all moderate-certainty evidence). One trial (88 participants) assessed the effectiveness of celecoxib (200 mg or 400 mg daily) in delaying cognitive decline in participants aged 40 to 81 years with mild age-related memory loss but normal memory performance scores. Mean duration of follow-up was 17.6 months in the celecoxib group and 18.1 months in the placebo group. There was no evidence of a difference between groups in test scores in any of six cognitive domains. Participants allocated celecoxib experienced more gastrointestinal adverse events than those allocated placebo (RR 2.66, 95% CI 1.05 to 6.75; low-certainty evidence). One trial (1457 participants) assessed the effectiveness of the COX-2 inhibitor rofecoxib (25 mg once daily) in delaying or preventing a diagnosis of AD in participants with MCI. Median duration of study participation was 115 weeks in the rofecoxib group and 130 weeks in the placebo group. There was a higher incidence of AD in the rofecoxib than the placebo group (RR 1.32, 95% CI 1.01 to 1.72; moderate-certainty evidence). There was no evidence of a difference between groups in cardiovascular adverse events (RR 1.07, 95% CI 0.68 to 1.66; moderate-certainty evidence) or mortality (RR 1.62, 95% CI 0.85 to 3.05; moderate-certainty evidence). Participants allocated rofecoxib had more upper gastrointestinal adverse events (RR 3.53, 95% CI 1.17 to 10.68; moderate-certainty evidence). Reported annual mean difference scores showed no evidence of a difference between groups in activities of daily living (year 1: no data available; year 2: 0.0, 95% CI -0.1 to 0.2; year 3: 0.1, 95% CI -0.1 to 0.3; year 4: 0.1, 95% CI -0.1 to 0.4; moderate-certainty evidence).
AUTHORS' CONCLUSIONS


There is no evidence to support the use of low-dose aspirin or other NSAIDs of any class (celecoxib, rofecoxib or naproxen) for the prevention of dementia, but there was evidence of harm. Although there were limitations in the available evidence, it seems unlikely that there is any need for further trials of low-dose aspirin for dementia prevention. If future studies of NSAIDs for dementia prevention are planned, they will need to be cognisant of the safety concerns arising from the existing studies.",2020,"Participants allocated rofecoxib had more upper gastrointestinal adverse events (RR 3.53, 95% CI 1.17 to 10.68; moderate-certainty evidence).","['participants with MCI', '23,187 participants', 'participants aged 40 to 81 years with mild age-related memory loss but normal memory performance scores', 'Participants were aged 70 years or older with no history of dementia, cardiovascular disease or physical disability', 'cognitively healthy participants (primary prevention) or participants with mild cognitive impairment (MCI) or cognitive complaints (secondary prevention', ""cognitively healthy older adults with a family history of Alzheimer's disease (AD""]","['aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs', 'cyclo-oxygenase-2 (COX-2) inhibitor celecoxib (200 mg twice daily) and the non-selective NSAID naproxen', 'Aspirin and other non-steroidal anti-inflammatory drugs', 'celecoxib ', 'aspirin', 'celecoxib', 'aspirin and placebo', 'class (celecoxib, rofecoxib or naproxen', 'aspirin or other NSAIDs with placebo', 'rofecoxib', 'COX-2 inhibitor rofecoxib', 'placebo']","['Mean duration', 'risk ratio (RR', 'delaying cognitive decline', 'rates of myocardial infarction', 'gastrointestinal adverse events', 'stroke', 'cardiovascular adverse events', 'mortality', 'incidence of dementia', 'incidence of AD', 'rates of major bleeding', 'Median duration of study participation', 'upper gastrointestinal adverse events', 'activities of daily living']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0002622', 'cui_str': 'Amnesia'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0679699', 'cui_str': 'Secondary prevention'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1271045', 'cui_str': ""FH: Alzheimer's disease""}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C1565860', 'cui_str': 'PTGS2 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0762662', 'cui_str': 'rofecoxib'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",19114.0,0.686924,"Participants allocated rofecoxib had more upper gastrointestinal adverse events (RR 3.53, 95% CI 1.17 to 10.68; moderate-certainty evidence).","[{'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'Jordan', 'Affiliation': 'School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Terry J', 'Initials': 'TJ', 'LastName': 'Quinn', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'McGuinness', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Passmore', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kelly', 'Affiliation': 'Pharmacology and Therapeutics, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Tudur Smith', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': 'School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'Devane', 'Affiliation': 'School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011459.pub2']
5,31219152,Depressive Symptoms Assessed Near the End of Pregnancy Predict Differential Response to Postpartum Smoking Relapse Prevention Intervention.,"BACKGROUND


Depressive symptoms are prevalent during pregnancy and the postpartum period and affect risk for smoking relapse. Whether and how depression affects response to postpartum interventions designed to sustain smoking abstinence is unknown.
PURPOSE


We examined end-of-pregnancy depressive symptoms as a moderator of response to two postpartum-adapted smoking relapse prevention interventions.
METHODS


Women (N = 300) who quit smoking during pregnancy were randomized to receive either a postpartum intervention focused on psychosocial factors linked to postpartum smoking (Strategies to Avoid Returning to Smoking [STARTS]) or an attention-controlled comparison intervention (SUPPORT). Women completed the Edinburgh Postnatal Depression Scale at the end of pregnancy. Smoking status was biochemically assessed at the end of pregnancy and at 12, 24, and 52 weeks postpartum.
RESULTS


End-of-pregnancy depressive symptoms moderated response to postpartum smoking relapse prevention interventions (χ2 = 10.18, p = .001). After controlling for variables previously linked to postpartum smoking relapse, women with clinically significant end-of-pregnancy depressive symptoms (20%) were more likely to sustain abstinence through 52 weeks postpartum if they received STARTS. In contrast, women with few end-of-pregnancy depressive symptoms were more likely to sustain abstinence through 52 weeks postpartum if they received SUPPORT. Changes in the psychosocial factors addressed in the STARTS intervention did not mediate this moderation effect.
CONCLUSION


Assessment of end-of-pregnancy depressive symptoms may help determine success following postpartum smoking relapse prevention interventions. Women with elevated end-of-pregnancy depressive symptoms benefited from postpartum relapse prevention intervention tailored to their psychosocial needs, while those with few symptoms were more successful in postpartum intervention that used standard behavioral components.
CLINICAL TRIAL REGISTRATION


NCT00757068.",2020,"Women with elevated end-of-pregnancy depressive symptoms benefited from postpartum relapse prevention intervention tailored to their psychosocial needs, while those with few symptoms were more successful in postpartum intervention that used standard behavioral components.
","['Women with elevated end-of-pregnancy depressive symptoms', 'Women (N = 300) who quit smoking during pregnancy']",['postpartum intervention focused on psychosocial factors linked to postpartum smoking (Strategies to Avoid Returning to Smoking [STARTS]) or an attention-controlled comparison intervention (SUPPORT'],"['Edinburgh Postnatal Depression Scale', 'pregnancy depressive symptoms', 'Smoking status']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",300.0,0.0865372,"Women with elevated end-of-pregnancy depressive symptoms benefited from postpartum relapse prevention intervention tailored to their psychosocial needs, while those with few symptoms were more successful in postpartum intervention that used standard behavioral components.
","[{'ForeName': 'Michele D', 'Initials': 'MD', 'LastName': 'Levine', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Emery', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Rachel P', 'Initials': 'RP', 'LastName': 'Kolko Conlon', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Marsha D', 'Initials': 'MD', 'LastName': 'Marcus', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Germeroth', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Salk', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Statistics and Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz026']
6,32398848,Localized versus 360° intraoperative laser retinopexy in cases of rhegmatogenous retinal detachment with mild-to-moderate grade proliferative vitreoretinopathy.,"BACKGROUND/OBJECTIVES


To compare the efficacy of intraoperative localized and 360° laser retinopexy in cases of rhegmatogenous retinal detachment (RRD) treated with pars plana vitrectomy and air tamponade.
SUBJECTS/METHODS


In this interventional, prospective, randomized, comparative study, 93 consecutive cases of RRD were enroled. After randomization 48 eyes received circumferential, while 45 underwent localized intraoperative laser retinopexy. Number and position of the retinal breaks, presence of proliferative vitreoretinopathy and/or lattice degeneration were recorded. Anatomical and visual outcome of the two groups were compared at 6 months postoperatively.
RESULTS


Baseline characteristics did not significantly differ between groups. The single-operation reattachment rate was 86.66% in localized group and 89.58% in 360° group. The difference was not significant. (P = 0.46, χ 2  test). At 6 months postoperatively, visual acuity (logMAR) was 0.06 ± 0.05 in localized group and 0.05 ± 0.03 in 360° group. The difference was not statistically significant (P = 0.673, t-test).
CONCLUSIONS


Localized laser resulted to be as effective as 360° laser application; this may lead some advantages in term of lower invasiveness, reduction risk of complications and time saving.",2021,The single-operation reattachment rate was 86.66% in localized group and 89.58% in 360° group.,"['cases of rhegmatogenous retinal detachment with mild-to-moderate grade proliferative vitreoretinopathy', 'cases of rhegmatogenous retinal detachment (RRD) treated with pars plana vitrectomy and air tamponade', '93 consecutive cases of RRD were enroled']","['intraoperative localized and 360° laser retinopexy', 'Localized versus 360° intraoperative laser retinopexy', 'localized intraoperative laser retinopexy']","['single-operation reattachment rate', 'visual acuity (logMAR', 'and/or lattice degeneration', 'Anatomical and visual outcome', 'Number and position of the retinal breaks, presence of proliferative vitreoretinopathy']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1868761', 'cui_str': 'Retinopexy'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0185042', 'cui_str': 'Reattachment - action'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0154856', 'cui_str': 'Retinal lattice degeneration'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0035321', 'cui_str': 'Retinal tear'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}]",93.0,0.0776211,The single-operation reattachment rate was 86.66% in localized group and 89.58% in 360° group.,"[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Loiudice', 'Affiliation': 'Ophthalmology Unit, Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy. ldcpasquale@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Montesel', 'Affiliation': 'Ophthalmology Unit, Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sartini', 'Affiliation': 'Ophthalmology Unit, Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Morganti', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Statistics, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Posarelli', 'Affiliation': 'Ophthalmology Unit, Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Nardi', 'Affiliation': 'Ophthalmology Unit, Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Figus', 'Affiliation': 'Ophthalmology Unit, Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Giamberto', 'Initials': 'G', 'LastName': 'Casini', 'Affiliation': 'Ophthalmology Unit, Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}]","Eye (London, England)",['10.1038/s41433-020-0950-9']
7,31784483,Genetic variability and potential effects on clinical trial outcomes: perspectives in Parkinson's disease.,"BACKGROUND


Classical randomisation of clinical trial patients creates a source of genetic variance that may be contributing to the high failure rate seen in neurodegenerative disease trials. Our objective was to quantify genetic difference between randomised trial arms and determine how imbalance can affect trial outcomes.
METHODS


5851 patients with Parkinson's disease of European ancestry data and two simulated virtual cohorts based on public data were used. Data were resampled at different sizes for 1000 iterations and randomly assigned to the two arms of a simulated trial. False-negative and false-positive rates were estimated using simulated clinical trials, and per cent difference in genetic risk score (GRS) and allele frequency was calculated to quantify variance between arms.
RESULTS


5851 patients with Parkinson's disease (mean (SD) age, 61.02 (12.61) years; 2095 women (35.81%)) as well as simulated patients from virtually created cohorts were used in the study. Approximately 90% of the iterations had at least one statistically significant difference in individual risk SNPs between each trial arm. Approximately 5%-6% of iterations had a statistically significant difference between trial arms in mean GRS. For significant iterations, the average per cent difference for mean GRS between trial arms was 130.87%, 95% CI 120.89 to 140.85 (n=200). Glucocerebrocidase (GBA) gene-only simulations see an average 18.86%, 95% CI 18.01 to 19.71 difference in GRS scores between trial arms (n=50). When adding a drug effect of -0.5 points in MDS-UPDRS per year at n=50, 33.9% of trials resulted in false negatives.
CONCLUSIONS


Our data support the hypothesis that within genetically unmatched clinical trials, genetic heterogeneity could confound true therapeutic effects as expected. Clinical trials should undergo pretrial genetic adjustment or, at the minimum, post-trial adjustment and analysis for failed trials.",2020,"Glucocerebrocidase (GBA) gene-only simulations see an average 18.86%, 95% CI 18.01 to 19.71 difference in GRS scores between trial arms (n=50).","[""5851 patients with Parkinson's disease of European ancestry data and two simulated virtual cohorts based on public data were used"", ""5851 patients with Parkinson's disease (mean (SD) age, 61.02"", '12.61) years; 2095 women (35.81%)) as well as simulated patients from virtually created cohorts were used in the study', ""Parkinson's disease""]",[],"['false negatives', 'genetic risk score (GRS) and allele frequency', 'individual risk SNPs', 'GRS scores', 'False-negative and false-positive rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0205558', 'cui_str': 'False negative (qualifier value)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017270', 'cui_str': 'Allele Frequency'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0205557', 'cui_str': 'False positive (qualifier value)'}]",2095.0,0.444393,"Glucocerebrocidase (GBA) gene-only simulations see an average 18.86%, 95% CI 18.01 to 19.71 difference in GRS scores between trial arms (n=50).","[{'ForeName': 'Hampton', 'Initials': 'H', 'LastName': 'Leonard', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Blauwendraat', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Krohn', 'Affiliation': 'Department of Human Genetics, McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Faraz', 'Initials': 'F', 'LastName': 'Faghri', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Iwaki', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Ferguson', 'Affiliation': 'Caserta Concepts LLC, New York City, New York, USA.'}, {'ForeName': 'Aaron G', 'Initials': 'AG', 'LastName': 'Day-Williams', 'Affiliation': 'Merck and Co, Boston, Massachusetts, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stone', 'Affiliation': 'Merck and Co, Boston, Massachusetts, USA.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Singleton', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Mike A', 'Initials': 'MA', 'LastName': 'Nalls', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA ziv.gan-or@mcgill.ca mike@datatecnica.com.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Gan-Or', 'Affiliation': 'Department of Human Genetics, McGill University, Montreal, Québec, Canada ziv.gan-or@mcgill.ca mike@datatecnica.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of medical genetics,['10.1136/jmedgenet-2019-106283']
8,31825647,Lung Screen Uptake Trial (LSUT): Randomized Controlled Clinical Trial Testing Targeted Invitation Materials.,"Rationale:  Low uptake of low-dose computed tomography (LDCT) lung cancer screening, particularly by current smokers of a low socioeconomic position, compromises effectiveness and equity. Objectives:  To compare the effect of a targeted, low-burden, and stepped invitation strategy versus control on uptake of hospital-based Lung Health Check appointments offering LDCT screening. Methods:  In a two-arm, blinded, between-subjects, randomized controlled trial, 2,012 participants were selected from 16 primary care practices using these criteria:  1 ) aged 60 to 75 years,  2 ) recorded as a current smoker within the last 7 years, and  3 ) no prespecified exclusion criteria contraindicating LDCT screening. Both groups received a stepped sequence of preinvitation, invitation, and reminder letters from their primary care practitioner offering prescheduled appointments. The key manipulation was the accompanying leaflet. The intervention group's leaflet targeted psychological barriers and provided low-burden information, mimicking the concept of the U.K. Ministry of Transport's annual vehicle test (""M.O.T. For Your Lungs""). Measurements and Main Results:  Uptake was 52.6%, with no difference between intervention (52.3%) and control (52.9%) groups in unadjusted (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.82-1.16) or adjusted (OR, 0.98; 95% CI, 0.82-1.17) analyses. Current smokers were less likely to attend (adjusted OR, 0.70; 95% CI, 0.56-0.86) than former smokers. Socioeconomic deprivation was significantly associated with lower uptake for the control group only ( P  < 0.01). Conclusions:  The intervention did not improve uptake. Regardless of trial arm, uptake was considerably higher than previous clinical and real-world studies, particularly given that the samples were predominantly lower socioeconomic position smokers. Strategies common to both groups, including a Lung Health Check approach, could represent a minimum standard.Clinical trial registered with www.clinicaltrials.gov (NCT02558101) and registered prospectively with the International Standard Registered Clinical/Social Study (N21774741).",2020,"Current smokers were less likely to attend (adjusted OR, 0.70; 95% CI, 0.56-0.86) than former smokers.","['Lung Screen Uptake Trial (LSUT', '2,012 participants were selected from 16 primary care practices using these criteria:  1 ) aged 60 to 75 years,  2 ) recorded as a current smoker within the last 7 years, and  3 ']","['low-dose computed tomography (LDCT) lung cancer screening', 'stepped sequence of preinvitation, invitation, and reminder letters from their primary care practitioner offering prescheduled appointments', 'intervention group\'s leaflet targeted psychological barriers and provided low-burden information, mimicking the concept of the U.K. Ministry of Transport\'s annual vehicle test (""M.O.T. For Your Lungs']","['Socioeconomic deprivation', 'uptake']","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}]",2012.0,0.164682,"Current smokers were less likely to attend (adjusted OR, 0.70; 95% CI, 0.56-0.86) than former smokers.","[{'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Quaife', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Ruparel', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, Division of Medicine, University College London, London, United Kingdom.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Dickson', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, Division of Medicine, University College London, London, United Kingdom.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Beeken', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'McEwen', 'Affiliation': 'National Centre for Smoking Cessation and Training, Dorchester, United Kingdom.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Respiratory Medicine Unit, David Evans Research Centre, Nottingham University Hospitals, Nottingham, United Kingdom.'}, {'ForeName': 'Angshu', 'Initials': 'A', 'LastName': 'Bhowmik', 'Affiliation': 'Department of Thoracic Medicine, Homerton University Hospital, London, United Kingdom.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Navani', 'Affiliation': 'Department of Thoracic Medicine, University College London Hospital, London, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sennett', 'Affiliation': 'Killick Street Health Centre, London, United Kingdom.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom; and.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Wardle', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Waller', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Janes', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, Division of Medicine, University College London, London, United Kingdom.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201905-0946OC']
9,32301388,Comparison of the effects of intravenous propofol and propofol with low-dose ketamine on preventing postextubation cough and laryngospasm among patients awakening from general anaesthesia: A prospective randomised clinical trial.,"BACKGROUND


Coughing and laryngospasm are undesirable consequences occurring when patients awaken from general anaesthesia. The objective of the study aimed to compare the effects of intravenous propofol and propofol with low-dose ketamine on preventing postextubation cough and laryngospasm.
METHODS


In all, 120 patients scheduled surgery under general anaesthesia were randomly assigned into three groups. Patients in the control group (C-group) received intravenous 0.9% NaCl, while patients in the propofol group (P-group) received intravenous 0.25mg/kg propofol and patients in the propofol combined with ketamine group (PK-group) received intravenous 0.25mg/kg of propofol plus 0.15mg/kg of ketamine. Drugs were administered before extubation. Incidence and severity of coughing and laryngospasm were recorded by a blinded anaesthesiologist.
RESULTS


Subjects of the PK-group (25%) experienced significantly reduced incidence of postoperative cough than that in the P-group (55%) and C-group (72.5%) (all P < 0.05). The severity of cough in the PK-group was significantly less than that in the P-group and C-group (P = 0.039 and P < 0.001, respectively). No significant difference was found in the incidence and severity of laryngospasm between comparison groups.
CONCLUSION


Intravenous combination of propofol and low-dose ketamine significantly reduced the incidence and severity among patients awakening from general anaesthesia.",2022,,['patients awakening from general anaesthesia'],['propofol and propofol with low-dose ketamine'],['postextubation cough and laryngospasm'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0023066', 'cui_str': 'Laryngeal spasm'}]",,0.0201312,,"[{'ForeName': 'Yanipan', 'Initials': 'Y', 'LastName': 'Chungsamarnyart', 'Affiliation': 'Department of Anesthesiology, Phramongkutklao Hospital and Phramongkutklao Collage of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Jiranun', 'Initials': 'J', 'LastName': 'Pairart', 'Affiliation': 'Department of Anesthesiology, Phramongkutklao Hospital and Phramongkutklao Collage of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Sithapan', 'Initials': 'S', 'LastName': 'Munjupong', 'Affiliation': 'Department of Anesthesiology, Phramongkutklao Hospital and Phramongkutklao Collage of Medicine, Bangkok, Thailand.'}]",Journal of perioperative practice,['10.1177/1750458920912636']
10,32311073,A Caretaker Acute Stress Paradigm: Effects on behavior and physiology of caretaker and infant.,"While experimental stress paradigms of infants (arm restraint; the Still-Face) are powerful tools for infant research, no study has experimentally stressed mothers to observe its independent effects on infant stress regulation. Extant caretaker/maternal stress studies essentially are correlational and confounded by other conditions (e.g., depression). Here, we present a standard procedure, the Caregiver Acute Stress Paradigm (CASP), for stressing mothers during en face interactions with their infants. We hypothesized that infants of the stressed mothers would be more distressed than infants of non-stressed mothers. A total of 106 four-month-old infants and their mothers were randomly assigned to the experimental stress or non-stress manipulation. Confirming our hypothesis, infants of the stressed mothers were significantly more likely to become distressed and require terminating the procedure. While objective ratings of maternal behavior showed no difference between groups, mother in the stress condition self-rated the episode following the caretaker stress significantly lower than mothers in the non-stress group. The self-ratings in the maternal stress-group were reflected in infant cortisol. The findings indicate that CASP is an effective experimental paradigm for exploring the independent effects of an acute stress on caretakers, including effects of conditions, such as poverty or mental illness.",2021,"Confirming our hypothesis, infants of the stressed mothers were significantly more likely to become distressed and require terminating the procedure.","['A Caretaker Acute Stress Paradigm', 'stressing mothers during en face interactions with their infants', 'A total of 106 four-month-old infants and their mothers']","['Caregiver Acute Stress Paradigm (CASP', 'experimental stress or non-stress manipulation', 'CASP']",['behavior and physiology of caretaker and infant'],"[{'cui': 'C0335350', 'cui_str': 'Building caretaker'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0335350', 'cui_str': 'Building caretaker'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",,0.0200918,"Confirming our hypothesis, infants of the stressed mothers were significantly more likely to become distressed and require terminating the procedure.","[{'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Tronick', 'Affiliation': 'Department of Psychology, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Mueller', 'Affiliation': 'Department of Psychology, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'DiCorcia', 'Affiliation': 'Department of Psychology, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Department of Psychology, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Snidman', 'Affiliation': 'Department of Psychology, University of Massachusetts Boston, Boston, MA, USA.'}]",Developmental psychobiology,['10.1002/dev.21974']
11,32003413,Transition to a More even Distribution of Daily Protein intake Is Associated with Enhanced Fat Loss during a Hypocaloric and Physical Activity Intervention in Obese Older Adults.,"BACKGROUND


Optimization of intentional weight loss in obese older adults, through preferential fat mass reduction, is challenging, as the concomitant lean mass loss may exacerbate sarcopenia. Recent studies have suggested within-day distribution of protein intake plays a role in determining body composition remodeling. Here, we assessed whether changes in within-day protein intake distribution are related to improvements in body composition in overweight/obese older adults during a hypocaloric and exercise intervention.
METHODS


Thirty-six community-dwelling, overweight-to-obese (BMI 28.0-39.9 kg/m2), sedentary older adults (aged 70.6±6.1 years) were randomized into either physical activity plus successful aging health education (PA+SA; n=15) or physical activity plus weight loss (PA+WL; n=21) programs. Body composition (by CT and DXA) and dietary intake (by three-day food records) were determined at baseline, 6-month, and 12-month follow-up visits. Within-day protein distribution was calculated as the coefficient of variation (CV) of protein ingested per defined time periods (breakfast [5:00-10:59], lunch [11:00-16:59] and dinner [17:00-1:00]). Secondary analysis was performed to determine associations between changes in protein intake distribution and body composition.
RESULTS


In both groups, baseline protein intake was skewed towards dinner (PA+SA: 49.1%; PA+WL: 54.1%). The pattern of protein intake changed towards a more even within-day distribution in PA+WL during the intervention period, but it remained unchanged in PA+SA. Transition towards a more even pattern of protein intake was independently associated with a greater decline in BMI (P<0.05) and abdominal subcutaneous fat (P<0.05) in PA+WL. However, changes in protein CV were not associated with changes in body weight in PA+SA.
CONCLUSION


Our results show that mealtime distribution of protein intake throughout the day was associated with improved weight and fat loss under hypocaloric diet combined with physical activity. This finding provides a novel insight into the potential role of within-day protein intake on weight management in obese older people.",2020,Transition towards a more even pattern of protein intake was independently associated with a greater decline in BMI (P<0.05) and abdominal subcutaneous fat (P<0.05) in PA+WL.,"['obese older people', 'Obese Older Adults', 'Thirty-six', 'obese older adults', 'overweight/obese older adults', 'community-dwelling, overweight-to-obese (BMI 28.0-39.9 kg/m2), sedentary older adults (aged 70.6±6.1 years']","['hypocaloric and exercise intervention', 'Hypocaloric and Hhysical Activity Intervention', 'physical activity plus successful aging health education (PA+SA; n=15) or physical activity plus weight loss (PA+WL; n=21) programs']","['body composition', 'Body composition (by CT and DXA) and dietary intake', 'protein intake distribution and body composition', 'weight and fat loss', 'body weight', 'baseline protein intake']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018701'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",36.0,0.0218255,Transition towards a more even pattern of protein intake was independently associated with a greater decline in BMI (P<0.05) and abdominal subcutaneous fat (P<0.05) in PA+WL.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Farsijani', 'Affiliation': 'Anne B. Newman, 5126 Public Health, 130 DeSoto Street, Pittsburgh, PA 15261, Office (412) 624-3056 Fax (412) 624-3737, Email: newmana@edc.pitt.edu.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Santanasto', 'Affiliation': ''}, {'ForeName': 'N W', 'Initials': 'NW', 'LastName': 'Glynn', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Boudreau', 'Affiliation': ''}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-020-1313-8']
12,32302757,Improving Family Navigation for Children With Autism: A Comparison of Two Pilot Randomized Controlled Trials.,"OBJECTIVE


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


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


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


Easy-to-implement system-level enhancements improved study recruitment, satisfaction with care, and completion of a diagnostic assessment. With enhancement, FN continued to confer benefits to families.",2021,"In the second pilot, compared to UC, FN continued increase the likelihood of completing the diagnostic assessment (HR: 2.57; 95% CI [1.22, 5.40]).
","['Children with Autism', '40 parent-child dyad participants with autism-related concerns', 'low-income, minority children']","['modified usual care (UC) or modified FN', 'Family Navigation (FN']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],,0.105002,"In the second pilot, compared to UC, FN continued increase the likelihood of completing the diagnostic assessment (HR: 2.57; 95% CI [1.22, 5.40]).
","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Feinberg', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, Boston University School of Medicine (E Feinberg, and S Broder-Fingert), Boston, Mass; Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass. Electronic address: emfeinbe@bu.edu.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Kuhn', 'Affiliation': 'Department of Pediatrics, Boston Medical Center (J Kuhn), Boston, Mass.'}, {'ForeName': 'Jenna Sandler', 'Initials': 'JS', 'LastName': 'Eilenberg', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Levinson', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Patts', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cabral', 'Affiliation': 'Boston University School of Public Health (E Feinberg, JS Eilenberg, J Levinson, G Patts, and H Cabral), Boston, Mass.'}, {'ForeName': 'Sarabeth', 'Initials': 'S', 'LastName': 'Broder-Fingert', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, Boston University School of Medicine (E Feinberg, and S Broder-Fingert), Boston, Mass.'}]",Academic pediatrics,['10.1016/j.acap.2020.04.007']
13,32223963,Multi-omic analysis of the effects of low frequency ventilation during cardiopulmonary bypass surgery.,"BACKGROUND


Heart surgery with cardio-pulmonary bypass (CPB) is associated with lung ischemia leading to injury and inflammation. It has been suggested this is a result of the lungs being kept deflated throughout the duration of CPB. Low frequency ventilation (LFV) during CPB has been proposed to reduce lung dysfunction.
METHODS


We used a semi-biased multi-omic approach to analyse lung biopsies taken before and after CPB from 37 patients undergoing coronary artery bypass surgery randomised to both lungs left collapsed or using LFV for the duration of CPB. We also examined inflammatory and oxidative stress markers from blood samples from the same patients.
RESULTS


30 genes were induced when the lungs were left collapsed and 80 by LFV. Post-surgery 26 genes were significantly higher in the LFV vs. lungs left collapsed, including genes associated with inflammation (e.g. IL6 and IL8) and hypoxia/ischemia (e.g. HIF1A, IER3 and FOS). Relatively few changes in protein levels were detected, perhaps reflecting the early time point or the importance of post-translational modifications. However, pathway analysis of proteomic data indicated that LFV was associated with increased ""cellular component morphogenesis"" and a decrease in ""blood circulation"". Lipidomic analysis did not identify any lipids significantly altered by either intervention.
DISCUSSION


Taken together these data indicate the keeping both lungs collapsed during CPB significantly induces lung damage, oxidative stress and inflammation. LFV during CPB increases these deleterious effects, potentially through prolonged surgery time, further decreasing blood flow to the lungs and enhancing hypoxia/ischemia.",2020,"Post-surgery 26 genes were significantly higher in the LFV vs. lungs left collapsed, including genes associated with inflammation (e.g. IL6 and IL8) and hypoxia/ischemia (e.g. HIF1A, IER3 and FOS).","['blood samples from the same patients', '37 patients undergoing coronary artery bypass surgery']","['low frequency ventilation', 'semi-biased multi-omic approach', 'LFV', 'cardiopulmonary bypass surgery', 'Low frequency ventilation (LFV', 'cardio-pulmonary bypass (CPB']","['protein levels', 'lung damage, oxidative stress and inflammation', 'inflammation (e.g. IL6 and IL8) and hypoxia/ischemia (e.g. HIF1A, IER3 and FOS', 'blood flow to the lungs and enhancing hypoxia/ischemia', 'blood circulation']","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}]","[{'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0005775', 'cui_str': 'Blood Circulation'}]",37.0,0.0239128,"Post-surgery 26 genes were significantly higher in the LFV vs. lungs left collapsed, including genes associated with inflammation (e.g. IL6 and IL8) and hypoxia/ischemia (e.g. HIF1A, IER3 and FOS).","[{'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Durham', 'Affiliation': 'Airways Disease Section, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK; Immunobiology, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 4 Newark St, London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Al Jaaly', 'Affiliation': 'Cardiothoracic Surgery, National Heart and Lung Institute, Imperial College London, Hammersmith Hospital, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Graham', 'Affiliation': 'Airways Disease Section, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK.'}, {'ForeName': 'P O', 'Initials': 'PO', 'LastName': 'Brook', 'Affiliation': 'Airways Disease Section, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Bae', 'Affiliation': 'Airways Disease Section, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Heesom', 'Affiliation': 'University of Bristol, Proteomics Facility, BioMedical Sciences Building, University Walk, Bristol, UK.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Postle', 'Affiliation': 'Faculty of Medicine, University of Southampton, Building 85, Life Sciences Building, Highfield Campus, Southampton, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lavender', 'Affiliation': ""Department of Asthma, Allergy, and Respiratory Science, King's College London, London, UK.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jazrawi', 'Affiliation': 'Airways Disease Section, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Reeves', 'Affiliation': 'Cardiothoracic Surgery, National Heart and Lung Institute, Imperial College London, Hammersmith Hospital, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Fiorentino', 'Affiliation': 'Cardiothoracic Surgery, National Heart and Lung Institute, Imperial College London, Hammersmith Hospital, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mumby', 'Affiliation': 'Airways Disease Section, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Angelini', 'Affiliation': 'Cardiothoracic Surgery, National Heart and Lung Institute, Imperial College London, Hammersmith Hospital, London, UK; Bristol Heart Institute, University of Bristol, Bristol Royal Infirmary, Level 7, Marlborough Street, Bristol, UK. Electronic address: g.d.angelini@bristol.ac.uk.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Adcock', 'Affiliation': 'Airways Disease Section, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.03.054']
14,32270862,Clinical Predictors of Liver Fibrosis Presence and Progression in Human Immunodeficiency Virus-Associated Nonalcoholic Fatty Liver Disease.,"BACKGROUND


Nonalcoholic fatty liver disease (NAFLD) affects more than one-third of people living with human immunodeficiency virus (HIV). Nonetheless, its natural history is poorly understood, including which patients are most likely to have a progressive disease course.
METHODS


We leveraged a randomized trial of the growth hormone-releasing hormone analogue tesamorelin to treat NAFLD in HIV. Sixty-one participants with HIV-associated NAFLD were randomized to tesamorelin or placebo for 12 months with serial biopsies.
RESULTS


In all participants with baseline biopsies (n = 58), 43% had hepatic fibrosis. Individuals with fibrosis had higher NAFLD Activity Score (NAS) (mean ± standard deviation [SD], 3.6 ± 2.0 vs 2.0 ± 0.8; P < .0001) and visceral fat content (mean ± SD, 284 ± 91 cm2 vs 212 ± 95 cm2; P = .005), but no difference in hepatic fat or body mass index. Among placebo-treated participants with paired biopsies (n = 24), 38% had hepatic fibrosis progression over 12 months. For each 25 cm2 higher visceral fat at baseline, odds of fibrosis progression increased by 37% (odds ratio, 1.37 [95% confidence interval, 1.03-2.07]). There was no difference in baseline NAS between fibrosis progressors and nonprogressors, though NAS rose over time in the progressor group (mean ± SD, 1.1 ± 0.8 vs -0.5 ± 0.6; P < .0001).
CONCLUSIONS


In this longitudinal study of HIV-associated NAFLD, high rates of hepatic fibrosis and progression were observed. Visceral adiposity was identified as a novel predictor of worsening fibrosis. In contrast, baseline histologic characteristics did not relate to fibrosis progression.",2021,"Individuals with fibrosis had higher NAFLD Activity Score (NAS) (3.6±2.0 vs. 2.0±0.8, P<0.0001) and visceral fat content (284±91 cm2 vs. 212±95 cm2, P=0.005), but no difference in hepatic fat or BMI.","['HIV', 'Sixty-one participants with HIV-associated NAFLD', 'people living with HIV', 'participants with baseline biopsies (n=58), 43% had hepatic fibrosis']","['growth hormone-releasing hormone analogue tesamorelin', 'tesamorelin or placebo', 'placebo']","['visceral fat content', 'hepatic fat or BMI', 'hepatic fibrosis progression', 'NAFLD Activity Score (NAS', 'baseline NAS score', 'NAS score rose over time', 'fibrosis progression', 'Visceral adiposity']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}]","[{'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C1876200', 'cui_str': 'tesamorelin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027446', 'cui_str': 'National Academy of Sciences (U.S.)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",61.0,0.217521,"Individuals with fibrosis had higher NAFLD Activity Score (NAS) (3.6±2.0 vs. 2.0±0.8, P<0.0001) and visceral fat content (284±91 cm2 vs. 212±95 cm2, P=0.005), but no difference in hepatic fat or BMI.","[{'ForeName': 'Lindsay T', 'Initials': 'LT', 'LastName': 'Fourman', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Takara L', 'Initials': 'TL', 'LastName': 'Stanley', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Zheng', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Chelsea S', 'Initials': 'CS', 'LastName': 'Pan', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Meghan N', 'Initials': 'MN', 'LastName': 'Feldpausch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Purdy', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Aepfelbacher', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Buckless', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Tsao', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Corey', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Chung', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Torriani', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kleiner', 'Affiliation': 'Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Hadigan', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa382']
15,32240370,Sustained remission of child depression despite drift in parent emotion management skills 18 weeks following Parent Child Interaction Therapy: emotion development.,"Whether effects of psychotherapies for depression are sustained after treatment is an important clinical issue. In older depressed children and adolescents such treatments have been shown to be sustained for several months. Rates of remission ranged from 62-69% at 3 months-1 year in one large scale study. To date there has been no data to inform whether the effects of earlier interventions for depression in the preschool period are sustained. To address this, we used data from a randomized controlled trial of a novel early intervention for depression called ""Parent Child Interaction Therapy Emotion Development"" (PCIT-ED) that has shown efficacy for depression, parenting stress and parenting practices. Participants and their caregivers were re-assessed 18 weeks after treatment completion. All study procedures were approved by the Washington University School of Medicine Internal Review Board prior to data collection. Study findings demonstrated a high rate of sustained gains in remission from depression, decreased parenting stress and parental depression 18 weeks after completion of a trial of PCIT-ED in a population of young children. Parental response to the child expression of emotion, a key treatment target drifted back towards baseline after 3 months. Relapse rates were 17% and predictors of relapse were the presence of an externalizing disorder, a higher number of co-morbid disorders and poorer guilt reparation and emotion regulation measured at treatment completion. This extends the body of literature demonstrating parent-child interaction therapy (PCIT) to have sustained effects on targeted disruptive symptom profiles to early childhood depression. This relatively low relapse rate after 18 weeks is comparable or better than many empirically proven treatments for depression in older children.",2021,"Study findings demonstrated a high rate of sustained gains in remission from depression, decreased parenting stress and parental depression 18 weeks after completion of a trial of PCIT-ED in a population of young children.","['older children', 'All study procedures were approved by the Washington University School of Medicine Internal Review Board prior to data collection']","['PCIT-ED', 'parent-child interaction therapy (PCIT', 'psychotherapies', 'novel early intervention for depression called ""Parent Child Interaction Therapy Emotion Development"" (PCIT-ED']","['Rates of remission', 'Relapse rates', 'number of co-morbid disorders and poorer guilt reparation and emotion regulation']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]","[{'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0754405,"Study findings demonstrated a high rate of sustained gains in remission from depression, decreased parenting stress and parental depression 18 weeks after completion of a trial of PCIT-ED in a population of young children.","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Luby', 'Affiliation': 'Washington University School of Medicine, Child Psychiatry, St. Louis, MO, 63130, USA. lubyj@wustl.edu.'}, {'ForeName': 'Meghan Rose', 'Initials': 'MR', 'LastName': 'Donohue', 'Affiliation': 'Washington University School of Medicine, Child Psychiatry, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Gilbert', 'Affiliation': 'Washington University School of Medicine, Child Psychiatry, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Tillman', 'Affiliation': 'Washington University School of Medicine, Child Psychiatry, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Barch', 'Affiliation': 'Department of Psychological and Brain Sciences, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}]",European child & adolescent psychiatry,['10.1007/s00787-020-01522-7']
16,32000738,Comparing enhanced versus standard Diabetes Prevention Program among indigenous adults in an urban setting: a randomized controlled trial.,"BACKGROUND


Indigenous people in the United States are at high risk for diabetes. Psychosocial stressors like historical trauma may impede success in diabetes prevention programs.
METHODS


A comparative effectiveness trial compared a culturally tailored diabetes prevention program (standard group) with an enhanced one that addressed psychosocial stressors (enhanced group) in 2015 to 2017. Participants were 207 Indigenous adults with a body mass index (BMI) of ≥30 and one additional criterion of metabolic syndrome, and were randomized to the standard or enhanced group. Both groups received a culturally tailored behavioral diabetes prevention program. Strategies to address psychosocial stressors were provided to the enhanced group only. Change in BMI over 12 months was the primary outcome. Secondary outcomes included change in quality of life, and clinical, behavioral, and psychosocial measures at 6 and 12 months.
RESULTS


The two groups did not significantly differ in BMI change at 12 months. The two groups also did not differ in any secondary outcomes at 6 or 12 months, with the exception of unhealthy food consumption; the standard group reported a larger mean decrease (95% CI) in consumption of unhealthy food compared with the enhanced group (- 4.6 [- 6.8, - 2.5] vs. -0.7 [- 2.9, 1.4], p = 0.01). At 6 months, significant improvements in weight and the physical component of the quality of life measure were observed for both groups compared with their baseline level. Compared with baseline, at 12 months, the standard group showed significant improvement in BMI (mean [95% CI], - 0.5 [- 1.0, - 0.1]) and the enhanced group showed significant improvement in the physical component of the quality of life (2.9 [0.7, 5.2]).
CONCLUSIONS


Adding strategies to address psychosocial barriers to a culturally tailored diabetes prevention program was not successful for improving weight loss among urban Indigenous adults.
TRIAL REGISTRATION


(if applicable): NCT02266576. Registered October 17, 2014 on clinicaltrials.gov. The trial was prospectively registered.",2020,"At 6 months, significant improvements in weight and the physical component of the quality of life measure were observed for both groups compared with their baseline level.","['urban Indigenous adults', 'indigenous adults in an urban setting', 'Participants were 207 Indigenous adults with a body mass index (BMI) of ≥30 and one additional criterion of metabolic syndrome', 'group) in 2015 to 2017']","['culturally tailored behavioral diabetes prevention program', 'standard Diabetes Prevention Program', 'culturally tailored diabetes prevention program (standard group) with an enhanced one that addressed psychosocial stressors (enhanced']","['Change in BMI', 'BMI change', 'weight loss', 'weight and the physical component of the quality of life measure', 'BMI', 'change in quality of life, and clinical, behavioral, and psychosocial measures', 'physical component of the quality of life', 'consumption of unhealthy food']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376649', 'cui_str': 'Address'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Food'}]",207.0,0.0784594,"At 6 months, significant improvements in weight and the physical component of the quality of life measure were observed for both groups compared with their baseline level.","[{'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, 1701 Page Mill Road, CA, Palo Alto, CA, 94304, USA. lgrosas@stanford.edu.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Vasquez', 'Affiliation': 'Office of Community Engagement, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Haley K', 'Initials': 'HK', 'LastName': 'Hedlin', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Fei Fei', 'Initials': 'FF', 'LastName': 'Qin', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Kendrick', 'Affiliation': 'American Indian Community Action Board, San Jose, CA, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Atencio', 'Affiliation': 'American Indian Community Action Board, San Jose, CA, USA.'}, {'ForeName': 'Randall S', 'Initials': 'RS', 'LastName': 'Stafford', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA, USA.'}]",BMC public health,['10.1186/s12889-020-8250-7']
17,32269549,Treatment of Upper Limb Paresis With Repetitive Peripheral Nerve Sensory Stimulation and Motor Training: Study Protocol for a Randomized Controlled Trial.,"Background:  Repetitive peripheral nerve sensory stimulation (RPSS) has emerged as a potential adjuvant strategy to motor training in stroke rehabilitation. The aim of this study is to test the hypothesis that 3 h sessions of active RPSS associated with functional electrical stimulation (FES) and task-specific training (TST) distributed three times a week, over 6 weeks, is more beneficial to improve upper limb motor function than sham RPSS in addition to FES and TST, in subjects with moderate to severe hand motor impairments in the chronic phase (>6 months) after stroke.  Methods:  In this single-center, randomized, placebo controlled, parallel-group, double-blind study we compare the effects of 18 sessions of active and sham RPSS as add-on interventions to FES and task-specific training of the paretic upper limb, in 40 subjects in the chronic phase after ischemic or hemorrhagic stroke, with Fugl-Meyer upper limb scores ranging from 7 to 50 and able to voluntarily activate any active range of wrist extension. The primary outcome measure is the Wolf Motor Function Test (WMFT) after 6 weeks of treatment. The secondary outcomes are the WMFT at 3, 10, and 18 weeks after beginning of treatment, as well as the following outcomes measured at 3, 6, 10, and 18 weeks: Motor Activity Log; active range of motion of wrist extension and flexion; grasp and pinch strength in the paretic and non-paretic sides (the order of testing is randomized within and across subjects); Modified Ashworth Scale; Fugl-Meyer Assessment-Upper Limb in the paretic arm; Barthel Index; Stroke Impact Scale.  Discussion:  This project represents a major step in developing a rehabilitation strategy with potential to have impact on the treatment of stroke patients with poor motor recovery in developing countries worldwide. The study preliminarily evaluates a straightforward, non-invasive, inexpensive intervention. If feasibility and preliminary efficacy are demonstrated, further investigations of the proposed intervention (underlying mechanisms/ effects in larger numbers of patients) should be performed.  Trial Registration:  NCT02658578.",2020,This project represents a major step in developing a rehabilitation strategy with potential to have impact on the treatment of stroke patients with poor motor recovery in developing countries worldwide.,"['subjects with moderate to severe hand motor impairments in the chronic phase (>6 months) after stroke', '40 subjects in the chronic phase after ischemic or hemorrhagic stroke, with Fugl-Meyer upper limb scores ranging from 7 to 50 and able to voluntarily activate any active range of wrist extension']","['placebo', 'Repetitive peripheral nerve sensory stimulation (RPSS', 'functional electrical stimulation (FES) and task-specific training (TST', 'Repetitive Peripheral Nerve Sensory Stimulation and Motor Training', 'active and sham RPSS']","['Wolf Motor Function Test (WMFT', 'Motor Activity Log; active range of motion of wrist extension and flexion; grasp and pinch strength in the paretic and non-paretic sides (the order of testing is randomized within and across subjects); Modified Ashworth Scale; Fugl-Meyer Assessment-Upper Limb in the paretic arm; Barthel Index; Stroke Impact Scale']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0575730', 'cui_str': 'Active range of wrist extension'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C0150763', 'cui_str': 'Sensory stimulation'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.223071,This project represents a major step in developing a rehabilitation strategy with potential to have impact on the treatment of stroke patients with poor motor recovery in developing countries worldwide.,"[{'ForeName': 'Adriana B', 'Initials': 'AB', 'LastName': 'Conforto', 'Affiliation': 'Departamento de Neurologia, Hospital das Clínicas, São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'André G', 'Initials': 'AG', 'LastName': 'Machado', 'Affiliation': 'Departament of Neurosciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, United States.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Menezes', 'Affiliation': 'Departamento de Neurologia, Hospital das Clínicas, São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'Nathalia H V', 'Initials': 'NHV', 'LastName': 'Ribeiro', 'Affiliation': 'Departamento de Neurologia, Hospital das Clínicas, São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Luccas', 'Affiliation': 'Departamento de Neurologia, Hospital das Clínicas, São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Pires', 'Affiliation': 'Departamento de Neurologia, Hospital das Clínicas, São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'Claudia da Costa', 'Initials': 'CDC', 'LastName': 'Leite', 'Affiliation': 'Núcleo de Apoio à Pesquisa em Neurociências (Center for Interdisciplinary Research on Applied Neurosciences: NAPNA), São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'Ela B', 'Initials': 'EB', 'LastName': 'Plow', 'Affiliation': 'Departament of Neurosciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, United States.'}, {'ForeName': 'Leonardo G', 'Initials': 'LG', 'LastName': 'Cohen', 'Affiliation': 'Human Cortical Physiology and Stroke Neurorehabilitation Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, United States.'}]",Frontiers in neurology,['10.3389/fneur.2020.00196']
18,22374991,"Gastric cancer incidence among Hispanics in California: patterns by time, nativity, and neighborhood characteristics.","BACKGROUND


Better understanding about gastric cancer incidence patterns among Hispanics by birthplace, socioeconomic status (SES), and acculturation can improve preventive strategies and disease models.
METHODS


Incidence rates, rate ratios, and estimated annual percent change (EAPC) in rates of anatomic and histologic subtype-specific gastric cancer were calculated by age, sex, and nativity among Hispanics using California Cancer Registry data from 1988 through 2004. Incidence rates in 1998 to 2002 were compared by neighborhood SES and Hispanic enclave status according to 2000 US Census data.
RESULTS


Incidence rates of diffuse gastric cancer increased from 1988 through 2004 among foreign-born Hispanic men (EAPC: 3.5%, 95% CI: 1.5%-5.5%) and U.S.-born Hispanic women (EAPC: 3.0%, 95% CI: 0.7%-5.3%). During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women. Noncardia and both intestinal and diffuse gastric cancer were more common in foreign-born than U.S.-born Hispanic men and women, and in those from lower SES, higher enclave neighborhoods. By contrast, among younger and middle-aged Hispanic men, cardia tumors were more common in the U.S.-born than the foreign-born, and in higher SES, lower enclave neighborhoods.
CONCLUSIONS


Varying gastric cancer risk factors among Hispanic subgroups and increasing rates of diffuse gastric cancer in foreign-born Hispanic men and U.S.-born Hispanic women merit further investigation to identify separate disease etiologies.
IMPACT


Age, sex, birthplace, SES, and acculturation modify gastric cancer incidence in Hispanics and should be considered when examining disease risk and prevention.",2012,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","['foreign-born Hispanic men and U.S.-born Hispanic women', 'younger and middle-aged Hispanic men, cardia tumors', 'Hispanics in California']",[],"['Noncardia and both intestinal and diffuse gastric cancer', 'Incidence rates', 'time, nativity, and neighborhood characteristics', 'cardia and noncardia gastric cancer', 'Incidence rates of diffuse gastric cancer', 'Incidence rates, rate ratios, and estimated annual percent change (EAPC) in rates of anatomic and histologic subtype-specific gastric cancer', 'Gastric cancer incidence', 'incidence rates of intestinal gastric cancer']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0006754', 'cui_str': 'California'}]",[],"[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.019428,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","[{'ForeName': 'Ellen T', 'Initials': 'ET', 'LastName': 'Chang', 'Affiliation': 'Cancer Prevention Institute of California, Fremont, CA, USA. echang@exponent.com'}, {'ForeName': 'Scarlett Lin', 'Initials': 'SL', 'LastName': 'Gomez', 'Affiliation': ''}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Fish', 'Affiliation': ''}, {'ForeName': 'Clayton W', 'Initials': 'CW', 'LastName': 'Schupp', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Parsonnet', 'Affiliation': ''}, {'ForeName': 'Mindy C', 'Initials': 'MC', 'LastName': 'DeRouen', 'Affiliation': ''}, {'ForeName': 'Theresa H M', 'Initials': 'TH', 'LastName': 'Keegan', 'Affiliation': ''}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Clarke', 'Affiliation': ''}, {'ForeName': 'Sally L', 'Initials': 'SL', 'LastName': 'Glaser', 'Affiliation': ''}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-11-1208']
19,30575628,Dopamine Optimizes Venous Return During Cardiopulmonary Bypass and Reduces the Need for Postoperative Blood Transfusion.,"Venodilation occurs shortly after the institution of cardiopulmonary bypass (CPB), necessitating fluid or vasoconstrictor administration to maintain adequate oxygen delivery. The vasoconstrictor effects of dopamine are not well studied in this context. Therefore, we conducted a single-center, double-blind case-control study to determine the role and utility of dopamine as a vasoconstrictor during CPB. The study included 60 adults who were scheduled for isolated elective/urgent coronary artery bypass grafting. Patients in group A (n = 30) received a dopamine bolus (2 mg) 20 min after cross-clamping, whereas patients in group B (n = 30) did not receive any intervention at a specific time point. Both groups received standard care as needed (fluid replacement or norepinephrine bolus). Venous return was measured directly in the reservoir and indirectly by Doppler measurement at the level of the inferior vena cava with transesophageal echocardiography. Both open and closed circuits were used for CPB. A single dopamine bolus (2 mg) increased volume in the venous reservoir in group A. Group A patients also received significantly fewer units of red blood cells in the intensive care unit (ICU) than did patients in group B. There were no significant between-group differences in postoperative bleeding, mechanical ventilation, or length of stay in the ICU. These findings suggest that use of a dopamine bolus can increase venous return and reduce the need for fluid replacement during and after CPB in patients undergoing coronary artery bypass grafting.",2019,"B. There were no significant between-group differences in postoperative bleeding, mechanical ventilation, or length of stay in the ICU.","['patients undergoing coronary artery bypass grafting', '60 adults who were scheduled for isolated elective/urgent coronary artery bypass grafting']","['dopamine bolus', 'Dopamine Optimizes Venous Return', 'standard care as needed (fluid replacement or norepinephrine bolus', 'dopamine']","['postoperative bleeding, mechanical ventilation, or length of stay in the ICU', 'Venodilation', 'red blood cells', 'Venous return']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0521302', 'cui_str': 'Body fluid replacement (procedure)'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}]","[{'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}]",60.0,0.0390132,"B. There were no significant between-group differences in postoperative bleeding, mechanical ventilation, or length of stay in the ICU.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moscarelli', 'Affiliation': 'From the GVM Care & Research, Department of Cardiovascular Surgery, Anthea Hospital, Bari, Italy.'}, {'ForeName': 'Ignazio', 'Initials': 'I', 'LastName': 'Condello', 'Affiliation': 'From the GVM Care & Research, Department of Cardiovascular Surgery, Anthea Hospital, Bari, Italy.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Fattouch', 'Affiliation': 'GVM Care & Research, Department of Cardiovascular Surgery, Villa Maria Eleonora, Palermo, Italy.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Punjabi', 'Affiliation': 'Hammersmith Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ajello', 'Affiliation': 'Department of Anesthesiology, Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Solimando', 'Affiliation': 'GVM Care & Research, Department of Anesthesia, Anthea Hospital, Bari, Italy.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Fiore', 'Affiliation': 'GVM Care & Research, Department of Anesthesia, Anthea Hospital, Bari, Italy.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Angelini', 'Affiliation': 'Bristol Royal Infirmary, Bristol, United Kingdom.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Speziale', 'Affiliation': 'From the GVM Care & Research, Department of Cardiovascular Surgery, Anthea Hospital, Bari, Italy.'}]",ASAIO journal (American Society for Artificial Internal Organs : 1992),['10.1097/MAT.0000000000000930']
20,32279170,Risk of hernia formation after radical prostatectomy: a comparison between open and robot-assisted laparoscopic radical prostatectomy within the prospectively controlled LAPPRO trial.,"PURPOSE


In addition to incisional hernia, inguinal hernia is a recognized complication to radical retropubic prostatectomy. To compare the risk of developing inguinal and incisional hernias after open radical prostatectomy compared to robot-assisted laparoscopic prostatectomy.
METHOD


Patients planned for prostatectomy were enrolled in the prospective, controlled LAPPRO trial between September 2008 and November 2011 at 14 hospitals in Sweden. Information regarding patient characteristics, operative techniques and occurrence of postoperative inguinal and incisional hernia were retrieved using six clinical record forms and four validated questionnaires.
RESULTS


3447 patients operated with radical prostatectomy were analyzed. Within 24 months, 262 patients developed an inguinal hernia, 189 (7.3%) after robot-assisted laparoscopic prostatectomy and 73 (8.4%) after open radical prostatectomy. The relative risk of having an inguinal hernia after robot-assisted laparoscopic prostatectomy was 18% lower compared to open radical retropubic prostatectomy, a non-significant difference. Risk factors for developing an inguinal hernia after prostatectomy were increased age, low BMI and previous hernia repair. The incidence of incisional hernia was low regardless of surgical technique. Limitations are the non-randomised setting.
CONCLUSIONS


We found no difference in incidence of inguinal hernia after open retropubic and robot-assisted laparoscopic radical prostatectomy. The low incidence of incisional hernia after both procedures did not allow for statistical analysis. Risk factors for developing an inguinal hernia after prostatectomy were increased age and BMI.",2022,We found no difference in incidence of inguinal hernia after open retropubic and robot-assisted laparoscopic radical prostatectomy.,"['Patients planned for prostatectomy were enrolled in the prospective, controlled LAPPRO trial between September 2008 and November 2011 at 14 hospitals in Sweden', '262 patients developed an inguinal hernia, 189 (7.3%) after', '3447 patients operated with radical prostatectomy']","['radical retropubic prostatectomy', 'radical prostatectomy', 'robot-assisted laparoscopic prostatectomy', 'open and robot-assisted laparoscopic radical prostatectomy', 'open radical retropubic prostatectomy', 'open retropubic and robot-assisted laparoscopic radical prostatectomy']","['incidence of inguinal hernia', 'postoperative inguinal and incisional hernia', 'relative risk of having an inguinal hernia', 'incidence of incisional hernia', 'incisional hernia', 'risk of developing inguinal and incisional hernias', 'Risk of hernia formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0194825', 'cui_str': 'Radical retropubic prostatectomy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4039115', 'cui_str': 'Robot assisted laparoscopic radical prostatectomy'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",3447.0,0.0434051,We found no difference in incidence of inguinal hernia after open retropubic and robot-assisted laparoscopic radical prostatectomy.,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nilsson', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, SSORG, Scandinavian Surgical Outcomes Research Group, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. hanna.nilsson@vgregion.se.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stranne', 'Affiliation': 'Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hugosson', 'Affiliation': 'Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wessman', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, SSORG, Scandinavian Surgical Outcomes Research Group, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Steineck', 'Affiliation': 'Division of Clinical Cancer Epidemiology Institute of Clinical Sciences, Sahlgrenska Academy At the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bjartell', 'Affiliation': 'Department of Urology, Skåne University Hospital, Lund University, Gothenburg, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Carlsson', 'Affiliation': 'Department of Molecular Medicine and Surgery, Section of Urology, Karolinska Institutet, Gothenburg, Sweden.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Thorsteinsdottir', 'Affiliation': 'Faculty of Nursing, Research Institute in Emergency Care, Landspitali University Hospital, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Tyritzis', 'Affiliation': 'Department of Molecular Medicine and Surgery, Section of Urology, Karolinska Institutet, Gothenburg, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lantz', 'Affiliation': 'Department of Molecular Medicine and Surgery, Section of Urology, Karolinska Institutet, Gothenburg, Sweden.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wiklund', 'Affiliation': 'Department of Molecular Medicine and Surgery, Section of Urology, Karolinska Institutet, Gothenburg, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Haglind', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, SSORG, Scandinavian Surgical Outcomes Research Group, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-020-02178-7']
21,32078683,Effect of Intravenous Tenecteplase Dose on Cerebral Reperfusion Before Thrombectomy in Patients With Large Vessel Occlusion Ischemic Stroke: The EXTEND-IA TNK Part 2 Randomized Clinical Trial.,"Importance


Intravenous thrombolysis with tenecteplase improves reperfusion prior to endovascular thrombectomy for ischemic stroke compared with alteplase.
Objective


To determine whether 0.40 mg/kg of tenecteplase safely improves reperfusion before endovascular thrombectomy vs 0.25 mg/kg of tenecteplase in patients with large vessel occlusion ischemic stroke.
Design, Setting, and Participants


Randomized clinical trial at 27 hospitals in Australia and 1 in New Zealand using open-label treatment and blinded assessment of radiological and clinical outcomes. Patients were enrolled from December 2017 to July 2019 with follow-up until October 2019. Adult patients (N = 300) with ischemic stroke due to occlusion of the intracranial internal carotid, \basilar, or middle cerebral artery were included less than 4.5 hours after symptom onset using standard intravenous thrombolysis eligibility criteria.
Interventions


Open-label tenecteplase at 0.40 mg/kg (maximum, 40 mg; n = 150) or 0.25 mg/kg (maximum, 25 mg; n = 150) given as a bolus before endovascular thrombectomy.
Main Outcomes and Measures


The primary outcome was reperfusion of greater than 50% of the involved ischemic territory prior to thrombectomy, assessed by consensus of 2 blinded neuroradiologists. Prespecified secondary outcomes were level of disability at day 90 (modified Rankin Scale [mRS] score; range, 0-6); mRS score of 0 to 1 (freedom from disability) or no change from baseline at 90 days; mRS score of 0 to 2 (functional independence) or no change from baseline at 90 days; substantial neurological improvement at 3 days; symptomatic intracranial hemorrhage within 36 hours; and all-cause death.
Results


All 300 patients who were randomized (mean age, 72.7 years; 141 [47%] women) completed the trial. The number of participants with greater than 50% reperfusion of the previously occluded vascular territory was 29 of 150 (19.3%) in the 0.40 mg/kg group vs 29 of 150 (19.3%) in the 0.25 mg/kg group (unadjusted risk difference, 0.0% [95% CI, -8.9% to -8.9%]; adjusted risk ratio, 1.03 [95% CI, 0.66-1.61]; P = .89). Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
Conclusions and Relevance


Among patients with large vessel occlusion ischemic stroke, a dose of 0.40 mg/kg, compared with 0.25 mg/kg, of tenecteplase did not significantly improve cerebral reperfusion prior to endovascular thrombectomy. The findings suggest that the 0.40-mg/kg dose of tenecteplase does not confer an advantage over the 0.25-mg/kg dose in patients with large vessel occlusion ischemic stroke in whom endovascular thrombectomy is planned.
Trial Registration


ClinicalTrials.gov Identifier: NCT03340493.",2020,"Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
","['Adult patients (N\u2009=\u2009300) with ischemic stroke due to occlusion of the intracranial internal carotid, \\basilar, or middle cerebral artery were included less than 4.5 hours after symptom onset using standard intravenous thrombolysis eligibility criteria', 'All 300 patients who were randomized (mean age, 72.7 years; 141 [47%] women) completed the trial', 'Patients With Large Vessel Occlusion Ischemic Stroke', 'Patients were enrolled from December 2017 to July 2019 with follow-up until October 2019', '27 hospitals in Australia and 1 in New Zealand using open-label treatment and blinded assessment of radiological and clinical outcomes', 'patients with large vessel occlusion ischemic stroke']","['Interventions\n\n\nOpen-label tenecteplase at 0.40 mg/kg (maximum, 40 mg; n\u2009=\u2009150) or 0.25 mg/kg']","['Cerebral Reperfusion', 'occluded vascular territory', 'cause deaths', 'symptomatic intracranial hemorrhage', 'cerebral reperfusion', '4 functional outcomes', 'reperfusion of greater than 50% of the involved ischemic territory prior to thrombectomy', 'level of disability at day 90 (modified Rankin Scale [mRS] score; range, 0-6); mRS score of 0 to 1 (freedom from disability) or no change from baseline at 90 days; mRS score of 0 to 2 (functional independence) or no change from baseline at 90 days; substantial neurological improvement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}]","[{'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",,0.594367,"Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
","[{'ForeName': 'Bruce C V', 'Initials': 'BCV', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'Yassi', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Dowling', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Bush', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Scroop', 'Affiliation': 'Department of Radiology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Simpson', 'Affiliation': 'Department of Neurology, Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brooks', 'Affiliation': 'Department of Radiology, Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Asadi', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Teddy Y', 'Initials': 'TY', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Darshan G', 'Initials': 'DG', 'LastName': 'Shah', 'Affiliation': 'Department of Neurology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Tissa', 'Initials': 'T', 'LastName': 'Wijeratne', 'Affiliation': 'Melbourne Medical School, Department of Medicine and Neurology, The University of Melbourne and Western Health, Sunshine Hospital, St Albans Victoria, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Fana', 'Initials': 'F', 'LastName': 'Alemseged', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ng', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bailey', 'Affiliation': 'Department of Neurology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Rice', 'Affiliation': 'Department of Radiology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'de Villiers', 'Affiliation': 'Department of Radiology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Dewey', 'Affiliation': 'Eastern Health and Eastern Health Clinical School, Department of Neurosciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Philip M C', 'Initials': 'PMC', 'LastName': 'Choi', 'Affiliation': 'Eastern Health and Eastern Health Clinical School, Department of Neurosciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Department of Neurology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kendal', 'Initials': 'K', 'LastName': 'Redmond', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leggett', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Fink', 'Affiliation': 'Department of Neurology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Collecutt', 'Affiliation': 'Department of Radiology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Medicine, Ballarat Base Hospital, Ballarat, Victoria, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Krause', 'Affiliation': 'Department of Neurology, Royal North Shore Hospital and Kolling Institute, University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Cordato', 'Affiliation': 'Department of Neurology, Liverpool Hospital, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Field', 'Affiliation': 'Department of Neurology, Lyell McEwin Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'School of Clinical Sciences, Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Neurology, Gosford Hospital, Gosford, New South Wales, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Clissold', 'Affiliation': 'Department of Neurology, University Hospital Geelong, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Miteff', 'Affiliation': 'Department of Neurology, Priority Research Centre for Brain and Mental Health Research, John Hunter Hospital, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Clissold', 'Affiliation': 'Department of Medicine, Southwest Healthcare, Warrnambool, Victoria, Australia.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Cloud', 'Affiliation': 'Department of Neurology, Alfred Hospital, Prahran, Victoria, Australia.'}, {'ForeName': 'Leslie E', 'Initials': 'LE', 'LastName': 'Bolitho', 'Affiliation': 'Department of Medicine, Northeast Health, Wangaratta, Victoria, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Bonavia', 'Affiliation': 'Department of Medicine, Albury Base Hospital, Albury, New South Wales, Australia.'}, {'ForeName': 'Arup', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Medicine, Goulburn Valley Health, Shepparton, Victoria, Australia.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'Department of Medicine, Latrobe Regional Health, Traralgon, Victoria, Australia.'}, {'ForeName': 'Abul', 'Initials': 'A', 'LastName': 'Mamun', 'Affiliation': 'Department of Medicine, Campbelltown Hospital, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Fintan', 'Initials': 'F', 'LastName': ""O'Rourke"", 'Affiliation': 'Department of Aged Care and Rehabilitation, Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Worthington', 'Affiliation': 'Department of Neurology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Wong', 'Affiliation': ""Department of Neurology, Royal Brisbane and Women's Hospital and the University of Queensland, Brisbane, Queensland, Australia.""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'Maridulu budyari gumal, The Sydney Partnership for Health Education Research & Enterprise (SPHERE), University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': 'Bladin', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Desmond', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.1511']
22,30967424,"Low-Dose Anti-Thymocyte Globulin Preserves C-Peptide, Reduces HbA 1c , and Increases Regulatory to Conventional T-Cell Ratios in New-Onset Type 1 Diabetes: Two-Year Clinical Trial Data.","A three-arm, randomized, double-masked, placebo-controlled phase 2b trial performed by the Type 1 Diabetes TrialNet Study Group previously demonstrated that low-dose anti-thymocyte globulin (ATG) (2.5 mg/kg) preserved β-cell function and reduced HbA 1c  for 1 year in new-onset type 1 diabetes. Subjects ( N  = 89) were randomized to  1 ) ATG and pegylated granulocyte colony-stimulating factor (GCSF),  2 ) ATG alone, or  3 ) placebo. Herein, we report 2-year area under the curve (AUC) C-peptide and HbA 1c , prespecified secondary end points, and potential immunologic correlates. The 2-year mean mixed-meal tolerance test-stimulated AUC C-peptide, analyzed by ANCOVA adjusting for baseline C-peptide, age, and sex ( n  = 82) with significance defined as one-sided  P  < 0.025, was significantly higher in subjects treated with ATG versus placebo ( P  = 0.00005) but not ATG/GCSF versus placebo ( P  = 0.032). HbA 1c  was significantly reduced at 2 years in subjects treated with ATG ( P  = 0.011) and ATG/GCSF ( P  = 0.022) versus placebo. Flow cytometry analyses demonstrated reduced circulating CD4:CD8 ratio, increased regulatory T-cell:conventional CD4 T-cell ratios, and increased PD-1 + CD4 +  T cells following low-dose ATG and ATG/GCSF. Low-dose ATG partially preserved β-cell function and reduced HbA 1c  2 years after therapy in new-onset type 1 diabetes. Future studies should determine whether low-dose ATG might prevent or delay the onset of type 1 diabetes.",2019,"Flow cytometry analyses demonstrated reduced circulating CD4:CD8 ratio, increased regulatory T-cell:conventional CD4 T-cell ratios, and increased PD-1 + CD4 +  T cells following low-dose ATG and ATG/GCSF.","['New-Onset Type 1 Diabetes', 'Subjects ( N  = 89) were randomized to  1 ']","['ATG and pegylated granulocyte colony-stimulating factor (GCSF),  2 ', 'placebo', 'Low-Dose Anti-Thymocyte Globulin', 'low-dose anti-thymocyte globulin (ATG) (2.5 mg/kg) preserved β-cell function and reduced HbA 1c', 'ATG versus placebo']","['2-year mean mixed-meal tolerance test-stimulated AUC C-peptide', 'β-cell function', 'HbA 1c', 'circulating CD4:CD8 ratio, increased regulatory T-cell:conventional CD4 T-cell ratios, and increased PD-1 + CD4 +  T cells']","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}]",89.0,0.279078,"Flow cytometry analyses demonstrated reduced circulating CD4:CD8 ratio, increased regulatory T-cell:conventional CD4 T-cell ratios, and increased PD-1 + CD4 +  T cells following low-dose ATG and ATG/GCSF.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Haller', 'Affiliation': 'University of Florida Diabetes Institute, Gainesville, FL hallemj@peds.ufl.edu.'}, {'ForeName': 'S Alice', 'Initials': 'SA', 'LastName': 'Long', 'Affiliation': 'Benaroya Research Institute, Seattle, WA.'}, {'ForeName': 'J Lori', 'Initials': 'JL', 'LastName': 'Blanchfield', 'Affiliation': 'Benaroya Research Institute, Seattle, WA.'}, {'ForeName': 'Desmond A', 'Initials': 'DA', 'LastName': 'Schatz', 'Affiliation': 'University of Florida Diabetes Institute, Gainesville, FL.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Skyler', 'Affiliation': 'Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Brian N', 'Initials': 'BN', 'LastName': 'Bundy', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Geyer', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Megan V', 'Initials': 'MV', 'LastName': 'Warnock', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Miller', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Atkinson', 'Affiliation': 'University of Florida Diabetes Institute, Gainesville, FL.'}, {'ForeName': 'Dorothy J', 'Initials': 'DJ', 'LastName': 'Becker', 'Affiliation': 'Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Baidal', 'Affiliation': 'Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'DiMeglio', 'Affiliation': 'Indiana University, Indianapolis, IN.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Gitelman', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Goland', 'Affiliation': 'Columbia University, New York, NY.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Gottlieb', 'Affiliation': 'University of Colorado Barbara Davis Center for Childhood Diabetes, Aurora, CO.'}, {'ForeName': 'Kevan C', 'Initials': 'KC', 'LastName': 'Herold', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Marks', 'Affiliation': 'Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Moran', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Rodriguez', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Russell', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Darrell M', 'Initials': 'DM', 'LastName': 'Wilson', 'Affiliation': 'Stanford University, Stanford, CA.'}, {'ForeName': 'Carla J', 'Initials': 'CJ', 'LastName': 'Greenbaum', 'Affiliation': 'Benaroya Research Institute, Seattle, WA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes,['10.2337/db19-0057']
23,32219407,The Effect of Improving Basic Preventive Measures in the Perioperative Arena on Staphylococcus aureus Transmission and Surgical Site Infections: A Randomized Clinical Trial.,"Importance


Surgical site infections increase patient morbidity and health care costs. The Centers for Disease Control and Prevention emphasize improved basic preventive measures to reduce bacterial transmission and infections among patients undergoing surgery.
Objective


To assess whether improved basic preventive measures can reduce perioperative Staphylococcus aureus transmission and surgical site infections.
Design, Setting, and Participants


This randomized clinical trial was conducted from September 20, 2018, to September 20, 2019, among 19 surgeons and their 236 associated patients at a major academic medical center with a 60-day follow-up period. Participants were a random sample of adult patients undergoing orthopedic total joint, orthopedic spine, oncologic gynecological, thoracic, general, colorectal, open vascular, plastic, or open urological surgery requiring general or regional anesthesia. Surgeons and their associated patients were randomized 1:1 via a random number generator to treatment group or to usual care. Observers were masked to patient groupings during assessment of outcome measures.
Interventions


Sustained improvements in perioperative hand hygiene, vascular care, environmental cleaning, and patient decolonization efforts.
Main Outcomes and Measures


Perioperative S aureus transmission assessed by the number of isolates transmitted and the incidence of transmission among patient care units (primary) and the incidence of surgical site infections (secondary).
Results


Of 236 patients (156 [66.1%] women; mean [SD] age, 57 [15] years), 106 (44.9%) and 130 (55.1%) were allocated to the treatment and control groups, respectively, received the intended treatment, and were analyzed for the primary outcome. Compared with the control group, the treatment group had a reduced mean (SD) number of transmitted perioperative S aureus isolates (1.25 [2.11] vs 0.47 [1.13]; P = .002). Treatment reduced the incidence of S aureus transmission (incidence risk ratio; 0.56; 95% CI, 0.37-0.86; P = .008; with robust variance clustering by surgeon: 95% CI, 0.42-0.76; P < .001). Overall, 11 patients (4.7%) experienced surgical site infections, 10 (7.7%) in the control group and 1 (0.9%) in the treatment group. Transmission was associated with an increased risk of surgical site infection (8 of 73 patients [11.0%] with transmission vs 3 of 163 [1.8%] without; risk ratio, 5.95; 95% CI, 1.62-21.86; P = .007). Treatment reduced the risk of surgical site infection (hazard ratio, 0.12; 95% CI, 0.02-0.92; P = .04; with clustering by surgeon: 95% CI, 0.03-0.51; P = .004).
Conclusions and Relevance


Improved basic preventive measures in the perioperative arena can reduce S aureus transmission and surgical site infections.
Trial Registration


ClinicalTrials.gov Identifier: NCT03638947.",2020,"Treatment reduced the risk of surgical site infection (hazard ratio, 0.12; 95% CI, 0.02-0.92; P = .04; with clustering by surgeon: 95% CI, 0.03-0.51; P = .004).
","['September 20, 2018, to September 20, 2019, among 19 surgeons and their 236 associated patients at a major academic medical center with a 60-day follow-up period', 'Participants were a random sample of adult patients undergoing orthopedic total joint, orthopedic spine, oncologic gynecological, thoracic, general, colorectal, open vascular, plastic, or open urological surgery requiring general or regional anesthesia', 'patients undergoing surgery', 'Staphylococcus aureus Transmission and Surgical Site Infections', '236 patients (156 [66.1%] women; mean [SD] age, 57 [15] years), 106 (44.9%) and']",['random number generator to treatment group or to usual care'],"['risk of surgical site infection', 'incidence of S aureus transmission', 'reduced mean (SD) number of transmitted perioperative S aureus isolates', 'perioperative hand hygiene, vascular care, environmental cleaning, and patient decolonization efforts', 'patient morbidity and health care costs', 'Measures\n\n\nPerioperative S aureus transmission assessed by the number of isolates transmitted and the incidence of transmission among patient care units (primary) and the incidence of surgical site infections (secondary', 'surgical site infections']","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0205478', 'cui_str': 'Oncologic (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0032167', 'cui_str': 'Plastics'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4520447', 'cui_str': 'Decolonization'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0017313'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",236.0,0.221262,"Treatment reduced the risk of surgical site infection (hazard ratio, 0.12; 95% CI, 0.02-0.92; P = .04; with clustering by surgeon: 95% CI, 0.03-0.51; P = .004).
","[{'ForeName': 'Randy W', 'Initials': 'RW', 'LastName': 'Loftus', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Franklin', 'Initials': 'F', 'LastName': 'Dexter', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Goodheart', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'McDonald', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Keech', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Noiseux', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pugely', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Sharp', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Mel', 'Initials': 'M', 'LastName': 'Sharafuddin', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'W Thomas', 'Initials': 'WT', 'LastName': 'Lawrence', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McGonagill', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Shanklin', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Dionne', 'Initials': 'D', 'LastName': 'Skeete', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Tracy', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Erickson', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Granchi', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Evans', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Schmidt', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Godding', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Raven', 'Initials': 'R', 'LastName': 'Brenneke', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Persons', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Herber', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Yeager', 'Affiliation': 'Department of Anesthesia, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Hadder', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Jeremiah R', 'Initials': 'JR', 'LastName': 'Brown', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1934']
24,31760132,Effect of omalizumab on lung function and eosinophil levels in adolescents with moderate-to-severe allergic asthma.,"BACKGROUND


Omalizumab improves clinical outcomes in patients with asthma. Several studies have shown lung function improvements with omalizumab; however, this has not been examined exclusively in adolescents.
OBJECTIVE


To assess the effect of omalizumab on lung function and eosinophil counts in adolescents with uncontrolled moderate-to-severe allergic asthma.
METHODS


In this post hoc analysis, data from adolescents aged 12 to 17 years from 8 randomized trials of omalizumab were pooled (studies 008, 009, and 011, and SOLAR, INNOVATE, ALTO, ETOPA, and EXTRA). Changes from baseline to end of study in forced expiratory volume in 1 second (FEV 1 ), percent predicted FEV 1  (ppFEV 1 ), forced vital capacity (FVC), and blood eosinophil counts were assessed by fitting an analysis of covariance model and calculating least squares mean (LSM) difference for omalizumab vs placebo.
RESULTS


A total of 340 adolescents were identified (omalizumab, n = 203 [59.7%]; placebo, n = 137 [40.3%]). Omalizumab increased all baseline lung function variables more than placebo by end of study: LSM treatment differences (95% confidence interval) were 3.0% (0.2%-5.7%; P = .035), 120.9 mL (30.6-211.2 mL; P = .009), and 101.5 mL (8.3-194.6 mL; P = .033) for ppFEV 1 , absolute FEV 1 , and FVC, respectively. The LSM difference demonstrated a greater reduction in eosinophil counts for omalizumab vs placebo: -85.9 cells/μL (-137.1 to -34.6 cells/μL; P = .001).
CONCLUSION


Omalizumab was associated with lung function improvements and circulating eosinophil counts reductions in adolescents with moderate-to-severe uncontrolled asthma. Findings emphasize the effect of omalizumab in young patients and the need to optimize treatment early in the disease course. https://clinicaltrials.gov/: NCT00314574, NCT00046748, NCT00401596.",2020,"Omalizumab increased all baseline lung function variables more than placebo by end of study: LSM treatment differences (95% confidence interval) were 3.0% (0.2%-5.7%; P = .035), 120.9 mL (30.6-211.2 mL; P = .009), and 101.5 mL (8.3-194.6 mL; P = .033) for ppFEV1, absolute FEV1, and FVC, respectively.","['adolescents with uncontrolled moderate-to-severe allergic asthma', '340 adolescents', 'patients with asthma', 'adolescents with moderate-to-severe uncontrolled asthma', 'adolescents with moderate-to-severe allergic asthma', 'adolescents aged 12 to 17 years from 8 randomized trials of', 'young patients']","['placebo', 'omalizumab', 'Omalizumab']","['baseline lung function variables', 'lung function and eosinophil counts', 'lung function and eosinophil levels', 'forced expiratory volume in 1 second (FEV1), percent predicted FEV1 (ppFEV1), forced vital capacity (FVC), and blood eosinophil counts', 'eosinophil counts']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma (disorder)'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count - observation'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0730561', 'cui_str': 'Percent predicted FEV1'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",340.0,0.28802,"Omalizumab increased all baseline lung function variables more than placebo by end of study: LSM treatment differences (95% confidence interval) were 3.0% (0.2%-5.7%; P = .035), 120.9 mL (30.6-211.2 mL; P = .009), and 101.5 mL (8.3-194.6 mL; P = .033) for ppFEV1, absolute FEV1, and FVC, respectively.","[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. Electronic address: wwb@medicine.wisc.edu.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Humbert', 'Affiliation': 'Université Paris-Sud, Paris, France.'}, {'ForeName': 'Tmirah', 'Initials': 'T', 'LastName': 'Haselkorn', 'Affiliation': 'EpiMetrix, Inc., Los Altos, California.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ortiz', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Trzaskoma', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Stephenson', 'Affiliation': 'Rho, Inc., Chapel Hill, North Carolina.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Garcia Conde', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Kianifard', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Holgate', 'Affiliation': 'University of Southampton, Southampton, United Kingdom.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2019.11.016']
25,31629852,NT-Pro BNP Predicts Myocardial Injury Post-vascular Surgery and is Reduced with CoQ 10 : A Randomized Double-Blind Trial.,"BACKGROUND


NT-Pro BNP levels provide incremental value in perioperative risk assessment prior to major noncardiac surgery. Whether they can be pharmacologically modified in patients prior to an elective vascular operation is uncertain.
METHODS


A double-blind, randomized controlled trial was implemented at a single institution. Patients were screened during their preoperative vascular clinic appointment and randomly assigned to CoQ 10  (400 mg per day) versus Placebo for 3 days prior to surgery. Biomarkers, including NT-Pro BNP, troponin I and C-reactive protein were obtained prior to and following surgery for up to 48 hours. The primary endpoint was postoperative NT-Pro BNP levels, and secondary endpoint measures included myocardial injury, defined by an elevated cardiac troponin level and length of stay.
RESULTS


One hundred and twenty-three patients were randomized to receive either CoQ 10  (N = 62) versus Placebo (N = 61) for 3 days before vascular surgery. Preoperative cardiac risks included ischemic heart disease (N = 52), CHF (N = 12), stroke (N = 23), and diabetes mellitus (N = 48) and the planned vascular procedures were infrainguinal (N = 78), carotid (N = 36), and intraabdominal (N = 9). There were no intergroup differences in these clinical variables. NT-Pro BNP levels (median; IQs) in the CoQ 10  and Placebo groups were 179 (75-347) and 217 (109-585) pg/ml, respectively, (P = 0.08) preoperatively, and 397 (211-686) and 591 (288-1,433) pg/ml respectively, (P = 0.01) at 24 hours following surgery. Patients with an elevated NT-Pro BNP had a higher incidence of myocardial injury, (58% vs. 20%; P < 0.01) and a longer hospital stay (4.4 ± 3.8 vs. 2.8 ± 3.2 days; P < 0.02) compared with individuals without an elevated NT-Pro BNP level.
CONCLUSIONS


NT-Pro BNP levels predict adverse events post-vascular surgery and are lowered in those patients assigned to preoperative administration of CoQ 10 .
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT03956017. Among patients undergoing elective vascular surgery, 123 patients were randomized to either CoQ 10  (400 mg/day) versus placebo for three days preoperatively. NT-Pro BNP levels (median; IQs) in the CoQ 10  and Placebo groups were 179 (75-347) and 217 (109-585) pg/ml, respectively, (P = 0.08) preoperatively, and 397 (211-686) and 591 (288-1,433) pg/ml, respectively, (P = 0.01) post-surgery. Patients with an elevated NT-Pro BNP had a higher incidence of myocardial injury (58% vs. 20%; P < 0.01) and a longer hospital stay (4.4 ± 3.8 vs. 2.8 ± 3.2 days; P < 0.02) compared with individuals without an NT-Pro BNP elevation. In conclusion, BNP predicts adverse outcomes and can be reduced with preoperative CoQ 10 .",2020,"CONCLUSIONS


NT-Pro BNP levels predict adverse events post-vascular surgery and are lowered in those patients assigned to preoperative administration of CoQ 10 .","['One hundred and twenty-three patients', 'Preoperative cardiac risks included ischemic heart disease (N=52), CHF (N=12), stroke (N=23) and diabetes mellitus (N=48) and the planned vascular procedures were infra-inguinal (N=78), carotid (N=36), and intraabdominal (N=9', 'Patients were screened during their preoperative vascular clinic appointment']","['CoQ10', 'Placebo', 'CoQ 10  (N=62) versus Placebo', 'NT-Pro BNP']","['myocardial injury', 'NT-Pro BNP levels', 'NT-Pro BNP, troponin I and C-reactive protein', 'longer hospital stay', 'postoperative NT-Pro BNP levels and secondary end-point measures included myocardial injury, defined by an elevated cardiac troponin level and length of stay']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}]","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",123.0,0.683498,"CONCLUSIONS


NT-Pro BNP levels predict adverse events post-vascular surgery and are lowered in those patients assigned to preoperative administration of CoQ 10 .","[{'ForeName': 'Asrar', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Division of Cardiology, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Johnson', 'Affiliation': 'Division of Cardiology, Minneapolis VA Medical Center, Minneapolis, MN.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Carlson', 'Affiliation': 'Division of Cardiology, University of Minnesota, Minneapolis, MN; Division of Cardiology, Minneapolis VA Medical Center, Minneapolis, MN.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hocum-Stone', 'Affiliation': 'Division of Cardiology, Minneapolis VA Medical Center, Minneapolis, MN; Division of Cardiothoracic Surgery, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Rosemary F', 'Initials': 'RF', 'LastName': 'Kelly', 'Affiliation': 'Division of Cardiothoracic Surgery, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Gravely', 'Affiliation': 'Department of Research Statistical Center, Minneapolis VA Medical Center, Minneapolis, MN.'}, {'ForeName': 'Mackenzi', 'Initials': 'M', 'LastName': 'Mbai', 'Affiliation': 'Division of Cardiology, University of Minnesota, Minneapolis, MN; Division of Cardiology, Minneapolis VA Medical Center, Minneapolis, MN.'}, {'ForeName': 'Derrick L', 'Initials': 'DL', 'LastName': 'Green', 'Affiliation': 'Division of Vascular Surgery, Minneapolis VA Medical Center, Minneapolis, MN.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Santilli', 'Affiliation': 'Division of Vascular Surgery, Minneapolis VA Medical Center, Minneapolis, MN.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Garcia', 'Affiliation': 'Division of Cardiology, Minneapolis Heart Institute, Minneapolis, MN.'}, {'ForeName': 'Selcuk', 'Initials': 'S', 'LastName': 'Adabag', 'Affiliation': 'Division of Cardiology, University of Minnesota, Minneapolis, MN; Division of Cardiology, Minneapolis VA Medical Center, Minneapolis, MN.'}, {'ForeName': 'Edward O', 'Initials': 'EO', 'LastName': 'McFalls', 'Affiliation': 'Division of Cardiology, University of Minnesota, Minneapolis, MN; Division of Cardiology, Minneapolis VA Medical Center, Minneapolis, MN. Electronic address: mcfal001@umn.edu.'}]",Annals of vascular surgery,['10.1016/j.avsg.2019.09.017']
26,32404980,Proteomic profiles before and during weight loss: Results from randomized trial of dietary intervention.,"Inflammatory and cardiovascular biomarkers have been associated with obesity, but little is known about how they change upon dietary intervention and concomitant weight loss. Further, protein biomarkers might be useful for predicting weight loss in overweight and obese individuals. We performed secondary analyses in the Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) randomized intervention trial that included healthy 609 adults (18-50 years old) with BMI 28-40 kg/m 2 , to evaluate associations between circulating protein biomarkers and BMI at baseline, during a weight loss diet intervention, and to assess predictive potential of baseline blood proteins on weight loss. We analyzed 263 plasma proteins at baseline and 6 months into the intervention using the Olink Proteomics CVD II, CVD III and Inflammation arrays. BMI was assessed at baseline, after 3 and 6 months of dietary intervention. At baseline, 102 of the examined inflammatory and cardiovascular biomarkers were associated with BMI (>90% with successful replication in 1,584 overweight/obese individuals from a community-based cohort study) and 130 tracked with weight loss shedding light into the pathophysiology of obesity. However, out of 263 proteins analyzed at baseline, only fibroblast growth factor 21 (FGF-21) predicted weight loss, and none helped individualize dietary assignment.",2020,"However, out of 263 proteins analyzed at baseline, only fibroblast growth factor 21 (FGF-21) predicted weight loss, and none helped individualize dietary assignment.","['overweight and obese individuals', 'healthy 609 adults (18-50 years old) with BMI 28-40\u2009kg/m 2']",['dietary intervention'],"['fibroblast growth factor 21 (FGF-21) predicted weight loss', 'weight loss', 'BMI']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",1584.0,0.0195217,"However, out of 263 proteins analyzed at baseline, only fibroblast growth factor 21 (FGF-21) predicted weight loss, and none helped individualize dietary assignment.","[{'ForeName': 'Sylwia M', 'Initials': 'SM', 'LastName': 'Figarska', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, CA, 94305, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rigdon', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ganna', 'Affiliation': 'Program in Medical and Population Genetics, Broad Institute of MIT and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Sölve', 'Initials': 'S', 'LastName': 'Elmståhl', 'Affiliation': 'Department of Clinical Sciences, Division of Geriatric Medicine, Lund University, Malmö University Hospital, Malmö, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lind', 'Affiliation': 'Department of Medical Sciences, Cardiovascular Epidemiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Diabetes Research Center, Stanford, CA, 94305, USA. cgardner@stanford.edu.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Ingelsson', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, CA, 94305, USA.'}]",Scientific reports,['10.1038/s41598-020-64636-7']
27,32170033,Randomised trial of azithromycin to eradicate  Ureaplasma  in preterm infants.,"OBJECTIVE


To test whether azithromycin eradicates  Ureaplasma  from the respiratory tract in preterm infants.
DESIGN


Prospective, phase IIb randomised, double-blind, placebo-controlled trial.
SETTING


Seven level III-IV US, academic, neonatal intensive care units (NICUs).
PATIENTS


Infants 24 0 -28 6  weeks' gestation (stratified 24 0 -26 6 ; 27 0 -28 6  weeks) randomly assigned within 4 days following birth from July 2013 to August 2016.
INTERVENTIONS


Intravenous azithromycin 20 mg/kg or an equal volume of D5W (placebo) every 24 hours for 3 days.
MAIN OUTCOME MEASURES


The primary efficacy outcome was  Ureaplasma -free survival. Secondary outcomes were all-cause mortality,  Ureaplasma  clearance, physiological bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age, comorbidities of prematurity and duration of respiratory support.
RESULTS


One hundred and twenty-one randomised participants (azithromycin: n=60; placebo: n=61) were included in the intent-to-treat analysis (mean gestational age 26.2±1.4 weeks). Forty-four of 121 participants (36%) were  Ureaplasma  positive (azithromycin: n=19; placebo: n=25).  Ureaplasma -free survival was 55/60 (92% (95% CI 82% to 97%)) for azithromycin compared with 37/61 (61% (95% CI 48% to 73%)) for placebo. Mortality was similar comparing the two treatment groups (5/60 (8%) vs 6/61 (10%)). Azithromycin effectively eradicated  Ureaplasma  in all azithromycin-assigned colonised infants, but 21/25 (84%)  Ureaplasma -colonised participants receiving placebo were culture positive at one or more follow-up timepoints. Most of the neonatal mortality and morbidity was concentrated in 21 infants with lower respiratory tract  Ureaplasma  colonisation. In a subgroup analysis, physiological BPD-free survival was 5/10 (50%) (95% CI 19% to 81%) among azithromycin-assigned infants with lower respiratory tract  Ureaplasma  colonisation versus 2/11 (18%) (95% CI 2% to 52%) in placebo-treated infants.
CONCLUSION


A 3-day azithromycin regimen effectively eradicated respiratory tract  Ureaplasma  colonisation in this study.
TRIAL REGISTRATION NUMBER


NCT01778634.",2020,"Azithromycin effectively eradicated  Ureaplasma  in all azithromycin-assigned colonised infants, but 21/25 (84%)  Ureaplasma -colonised participants receiving placebo were culture positive at one or more follow-up timepoints.","['27 0', '21 infants with lower respiratory tract  Ureaplasma  colonisation', 'n=60', 'preterm infants', 'Forty-four of 121 participants (36%) were', 'Seven level III-IV US, academic, neonatal intensive care units (NICUs', 'One hundred and twenty-one randomised participants', 'Infants 24 0']","['azithromycin', 'Azithromycin', 'placebo', 'Intravenous azithromycin 20 mg/kg or an equal volume of D5W (placebo']","['Ureaplasma -free survival', ""cause mortality,  Ureaplasma  clearance, physiological bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age, comorbidities of prematurity and duration of respiratory support"", 'neonatal mortality and morbidity', 'Mortality', 'physiological BPD-free survival']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0282335', 'cui_str': 'Respiratory Tract'}, {'cui': 'C0041944', 'cui_str': 'T-Mycoplasma'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0441927', 'cui_str': 'Level III (tumor staging)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0041944', 'cui_str': 'T-Mycoplasma'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0728731', 'cui_str': 'Prematurity of fetus (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",21.0,0.779323,"Azithromycin effectively eradicated  Ureaplasma  in all azithromycin-assigned colonised infants, but 21/25 (84%)  Ureaplasma -colonised participants receiving placebo were culture positive at one or more follow-up timepoints.","[{'ForeName': 'Rose Marie', 'Initials': 'RM', 'LastName': 'Viscardi', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland, USA rviscard@som.umaryland.edu.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Terrin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Magder', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, University of Maryland Baltimore, Baltimore, Maryland, USA.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dulkerian', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Ken B', 'Initials': 'KB', 'LastName': 'Waites', 'Affiliation': 'Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'Department of Pediatrics, University of Virginia School of Medicine, Charlottesville, Virginia, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Donohue', 'Affiliation': 'Department of Pediatrics, Johns Hopkins Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Tuttle', 'Affiliation': 'Department of Pediatrics, Christiana Care Health System, Newark, Delaware, USA.'}, {'ForeName': 'Jorn-Hendrik', 'Initials': 'JH', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Hazem E', 'Initials': 'HE', 'LastName': 'Hassan', 'Affiliation': 'University of Maryland School of Pharmacy, Baltimore, Maryland, USA.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Eddington', 'Affiliation': 'University of Maryland School of Pharmacy, Baltimore, Maryland, USA.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-318122']
28,31049783,Evaluating the effects of switching from cigarette smoking to using a heated tobacco product on health effect indicators in healthy subjects: study protocol for a randomized controlled trial.,"Tobacco heating products (THPs) are a potentially safer alternative to combustible cigarette smoking. Through continued use, THPs may reduce smoking-related disease risk, whilst maintaining the sensorial experience and nicotine delivery sought by smokers. While literature evidence of the biological effects of THP aerosol exposure is increasing, there remains a knowledge gap with respect to substantiation of THP reduced risk potential in longer term real-life use. This randomized, multi-centre, controlled clinical study will test the hypotheses that following a switch from combustible cigarettes to a THP for 1 year, participants will experience a sustained reduction in exposure to tobacco-related toxicants that will lead to favourable changes in health effect indicators associated with smoking-related disease development. Changes in such indicators will be contextualized against smoking cessation and never-smoker cohorts. Up to 280 participants who do not intend to quit smoking will be randomized to continued combustible smoking (arm A, up to n = 80) or a commercially available THP (arm B n = 200). Furthermore, up to 190 participants with a high intent to quit smoking will undergo smoking cessation (arm D), and 40 never smokers will serve as a control group (arm E). Recruitment numbers were determined to be sufficient to achieve n = 50 in arms A, B and D, at study end. Enrolment started in March 2018 and the trial is scheduled to be completed in March 2020. Data from this study will be a valuable addition to the growing body of evidence in the field of understanding the individual and public health impact of THPs.Clinical Trial Registration: https://www.isrctn.com/ISRCTN81075760.",2019,"Recruitment numbers were determined to be sufficient to achieve n = 50 in arms A, B and D, at study end.","['280 participants who do not intend to quit smoking', '190 participants with a high intent to quit smoking will undergo smoking cessation (arm D), and 40 never smokers will serve as a control group (arm E', 'healthy subjects']","['heated tobacco product', 'Tobacco heating products (THPs', 'continued combustible smoking (arm A, up to n\u2009=\u200980) or a commercially available THP']",[],"[{'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0217641', 'cui_str': '4-Pyrimidinecarboxylic acid, 1,4,5,6-tetrahydro-2-methyl-'}]",[],190.0,0.0626483,"Recruitment numbers were determined to be sufficient to achieve n = 50 in arms A, B and D, at study end.","[{'ForeName': 'Nik', 'Initials': 'N', 'LastName': 'Newland', 'Affiliation': 'Group Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.'}, {'ForeName': 'Frazer John', 'Initials': 'FJ', 'LastName': 'Lowe', 'Affiliation': 'Group Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK. frazer_lowe@bat.com.'}, {'ForeName': 'Oscar Martin', 'Initials': 'OM', 'LastName': 'Camacho', 'Affiliation': 'Group Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'McEwan', 'Affiliation': 'Group Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Gale', 'Affiliation': 'Group Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ebajemito', 'Affiliation': 'Group Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hardie', 'Affiliation': 'Group Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'Group Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Proctor', 'Affiliation': 'Group Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, Southampton, SO15 8TL, UK.'}]",Internal and emergency medicine,['10.1007/s11739-019-02090-8']
29,23690531,Rationale and design of the glycemia reduction approaches in diabetes: a comparative effectiveness study (GRADE).,"OBJECTIVE


The epidemic of type 2 diabetes (T2DM) threatens to become the major public health problem of this century. However, a comprehensive comparison of the long-term effects of medications to treat T2DM has not been conducted. GRADE, a pragmatic, unmasked clinical trial, aims to compare commonly used diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and patient-centered outcomes.
RESEARCH DESIGN AND METHODS


GRADE was designed with support from a U34 planning grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The consensus protocol was approved by NIDDK and the GRADE Research Group. Eligibility criteria for the 5,000 metformin-treated subjects include <5 years' diabetes duration, ≥ 30 years of age at time of diagnosis, and baseline hemoglobin A1c (A1C) of 6.8-8.5% (51-69 mmol/mol). Medications representing four classes (sulfonylureas, dipeptidyl peptidase 4 inhibitors, glucagon-like peptide 1 receptor agonists, and insulin) will be randomly assigned and added to metformin (minimum-maximum 1,000-2,000 mg/day). The primary metabolic outcome is the time to primary failure defined as an A1C ≥ 7% (53 mmol/mol), subsequently confirmed, over an anticipated mean observation period of 4.8 years (range 4-7 years). Other long-term metabolic outcomes include the need for the addition of basal insulin after a confirmed A1C >7.5% (58 mmol/mol) and, ultimately, the need to implement an intensive basal/bolus insulin regimen. The four drugs will also be compared with respect to selected microvascular complications, cardiovascular disease risk factors, adverse effects, tolerability, quality of life, and cost-effectiveness.
CONCLUSIONS


GRADE will compare the long-term effectiveness of major glycemia-lowering medications and provide guidance to clinicians about the most appropriate medications to treat T2DM. GRADE begins recruitment at 37 centers in the U.S. in 2013.",2013,"The four drugs will also be compared with respect to selected microvascular complications, cardiovascular disease risk factors, adverse effects, tolerability, quality of life, and cost-effectiveness.
","['diabetes', ""Eligibility criteria for the 5,000 metformin-treated subjects include <5 years' diabetes duration, ≥ 30 years of age at time of diagnosis, and baseline hemoglobin A1c (A1C) of 6.8-8.5% (51-69 mmol/mol"", 'GRADE was designed with support from a U34 planning grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK']","['Medications representing four classes (sulfonylureas, dipeptidyl peptidase 4 inhibitors, glucagon-like peptide 1 receptor agonists, and insulin', 'metformin']","['microvascular complications, cardiovascular disease risk factors, adverse effects, tolerability, quality of life, and cost-effectiveness', 'time to primary failure defined as an A1C ≥']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C1513898', 'cui_str': 'NIDDK'}]","[{'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}]",,0.103931,"The four drugs will also be compared with respect to selected microvascular complications, cardiovascular disease risk factors, adverse effects, tolerability, quality of life, and cost-effectiveness.
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Nathan', 'Affiliation': 'Diabetes Research Center, Massachusetts General Hospital and Harvard School of Medicine, Boston, Massachusetts, USA. heidi@bsc.gwu.edu'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': ''}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': ''}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Krause-Steinrauf', 'Affiliation': ''}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larkin', 'Affiliation': ''}, {'ForeName': 'Myrlene', 'Initials': 'M', 'LastName': 'Staten', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Wexler', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Lachin', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc13-0356']
30,30712148,"A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic profiles of cigarettes and e-cigarettes with nicotine salt formulations in US adult smokers.","E-cigarettes containing 'nicotine salts' aim to increase smoker's satisfaction by improving blood nicotine delivery and other sensory properties. Here, we evaluated the pharmacokinetic profiles and subjective effects of nicotine from two e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt) e-liquid relative to conventional cigarettes. A randomised, open-label, cross-over clinical study was conducted in 15 healthy US adult smokers. Five different e-cigarette products were evaluated consecutively on different days after use of own brand conventional cigarette. Plasma nicotine pharmacokinetics, subjective effects, and tolerability were assessed following controlled use of the products. The rate of nicotine absorption into the bloodstream was comparable from all e-cigarettes tested and was as rapid as that for conventional cigarette. However, in all cases, nicotine delivery did not exceed that of the conventional cigarette. The pharmacokinetic profiles of nicotine salt emissions were also dependent upon the properties of the e-cigarette device. Subjective scores were numerically highest after smoking a conventional cigarette followed by the myblu 40-mg nicotine salt formulation. The rise in nicotine blood levels following use of all the tested e-cigarettes was quantified as 'a little' to 'modestly' satisfying at relieving the desire to smoke. All products were well tolerated with no notable adverse events reported. These results demonstrate that, while delivering less nicotine than a conventional cigarette, the use of nicotine salts in e-cigarettes enables cigarette-like pulmonary delivery of nicotine that reduces desire to smoke.",2019,All products were well tolerated with no notable adverse events reported.,"['US adult smokers', '15 healthy US adult smokers']","['nicotine', 'nicotine lactate (nicotine salt) e-liquid relative to conventional cigarettes', ""E-cigarettes containing 'nicotine salts"", 'nicotine salt formulations', 'nicotine salts']","['Subjective scores', 'Plasma nicotine pharmacokinetics, subjective effects, and tolerability', 'rate of nicotine absorption into the bloodstream', 'nicotine blood levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid (physical object)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",15.0,0.0107327,All products were well tolerated with no notable adverse events reported.,"[{'ForeName': 'Grant', 'Initials': 'G', 'LastName': ""O'Connell"", 'Affiliation': 'Imperial Brands plc, 121 Winterstoke Road, Bristol, BS3 2LL, UK. grant.oconnell@uk.imptob.com.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Pritchard', 'Affiliation': 'Imperial Brands plc, 121 Winterstoke Road, Bristol, BS3 2LL, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Prue', 'Affiliation': 'Imperial Brands plc, 121 Winterstoke Road, Bristol, BS3 2LL, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Imperial Brands plc, 121 Winterstoke Road, Bristol, BS3 2LL, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Verron', 'Affiliation': 'Imperial Brands plc, 121 Winterstoke Road, Bristol, BS3 2LL, UK.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Graff', 'Affiliation': 'Celerion Inc., 621 Rose Street, Lincoln, NE, 68502, USA.'}, {'ForeName': 'Tanvir', 'Initials': 'T', 'LastName': 'Walele', 'Affiliation': 'Imperial Brands plc, 121 Winterstoke Road, Bristol, BS3 2LL, UK. Tanvir.Walele@fontemventures.com.'}]",Internal and emergency medicine,['10.1007/s11739-019-02025-3']
31,32193981,Pilot Outcomes of a Multicomponent Fall Risk Program Integrated Into Daily Lives of Community-Dwelling Older Adults.,"Objectives:  To evaluate whether a fall prevention intervention reduces fall risk in older adults who have previously fallen.  Design:  Randomized controlled pilot trial.  Setting:  Participants' homes.  Intervention:  LIVE-LiFE, adapted from Lifestyle-Intervention Functional Exercise (LiFE) integrates strength and balance training into daily habits in eight visits over 12 weeks. The adaptations to LiFE were to also provide (a) US$500 in home safety changes, (b) vision contrast screening and referral, and (c) medication recommendations. Control condition consisted of fall prevention materials and individualized fall risk summary.  Measurement:  Timed Up and Go (TUG) and Tandem stand. Falls efficacy, feasibility, and acceptability of the intervention.  Results:  Sample ( N  = 37) was 65% female, 65% White, and average 77 years. Compared with the control group, each outcome improved in the intervention. The LIVE-LiFE intervention had a large effect (1.1) for tandem stand, moderate (0.5) in falls efficacy, and small (0.1) in the TUG.  Conclusion:  Simultaneously addressing preventable fall risk factors is feasible.",2021,"The LIVE-LiFE intervention had a large effect (1.1) for tandem stand, moderate (0.5) in falls efficacy, and small (0.1) in the TUG.  ","[""Participants' homes"", 'older adults who have previously fallen', 'Results:  Sample ( N  = 37) was 65% female, 65% White, and average 77 years', 'daily habits in eight visits over 12 weeks', 'Community-Dwelling Older Adults']","['Multicomponent Fall Risk Program', 'LIVE-LiFE, adapted from Lifestyle-Intervention Functional Exercise (LiFE) integrates strength and balance training', 'fall prevention intervention']","['Measurement:  Timed Up and Go (TUG) and Tandem stand', 'Falls efficacy, feasibility, and acceptability']","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0204825,"The LIVE-LiFE intervention had a large effect (1.1) for tandem stand, moderate (0.5) in falls efficacy, and small (0.1) in the TUG.  ","[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Szanton', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'The University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Minhui', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Hladek', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'LaFave', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Roth', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Marx', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Felix', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Safiyyah M', 'Initials': 'SM', 'LastName': 'Okoye', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Bautista', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Granbom', 'Affiliation': 'Lund University, Sweden.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464820912664']
32,30522922,"Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial.","BACKGROUND


Based on the encouraging activity and manageable safety profile observed in a phase 1 study, the ECHELON-2 trial was initiated to compare the efficacy and safety of brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone (A+CHP) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) for the treatment of CD30-positive peripheral T-cell lymphomas.
METHODS


ECHELON-2 is a double-blind, double-dummy, randomised, placebo-controlled, active-comparator phase 3 study. Eligible adults from 132 sites in 17 countries with previously untreated CD30-positive peripheral T-cell lymphomas (targeting 75% with systemic anaplastic large cell lymphoma) were randomly assigned 1:1 to receive either A+CHP or CHOP for six or eight 21-day cycles. Randomisation was stratified by histological subtype according to local pathology assessment and by international prognostic index score. All patients received cyclophosphamide 750 mg/m 2  and doxorubicin 50 mg/m 2  on day 1 of each cycle intravenously and prednisone 100 mg once daily on days 1 to 5 of each cycle orally, followed by either brentuximab vedotin 1·8 mg/kg and a placebo form of vincristine intravenously (A+CHP group) or vincristine 1·4 mg/m 2  and a placebo form of brentuximab vedotin intravenously (CHOP group) on day 1 of each cycle. The primary endpoint, progression-free survival according to blinded independent central review, was analysed by intent-to-treat. This trial is registered with ClinicalTrials.gov, number NCT01777152.
FINDINGS


Between Jan 24, 2013, and Nov 7, 2016, 601 patients assessed for eligibility, of whom 452 patients were enrolled and 226 were randomly assigned to both the A+CHP group and the CHOP group. Median progression-free survival was 48·2 months (95% CI 35·2-not evaluable) in the A+CHP group and 20·8 months (12·7-47·6) in the CHOP group (hazard ratio 0·71 [95% CI 0·54-0·93], p=0·0110). Adverse events, including incidence and severity of febrile neutropenia (41 [18%] patients in the A+CHP group and 33 [15%] in the CHOP group) and peripheral neuropathy (117 [52%] in the A+CHP group and 124 [55%] in the CHOP group), were similar between groups. Fatal adverse events occurred in seven (3%) patients in the A+CHP group and nine (4%) in the CHOP group.
INTERPRETATION


Front-line treatment with A+CHP is superior to CHOP for patients with CD30-positive peripheral T-cell lymphomas as shown by a significant improvement in progression-free survival and overall survival with a manageable safety profile.
FUNDING


Seattle Genetics Inc, Millennium Pharmaceuticals Inc, a wholly owned subsidiary of Takeda Pharmacuetical Company Limited, and National Institutes of Health National Cancer Institute Cancer Center.",2019,Median progression-free survival was 48·2 months (95% CI 35·2-not evaluable) in the A+CHP group and 20·8 months (12·7-47·6) in the CHOP group (,"['Eligible adults from 132 sites in 17 countries with previously untreated CD30-positive peripheral T-cell lymphomas (targeting 75% with systemic anaplastic large cell lymphoma', 'CD30-positive peripheral T-cell lymphomas', '601 patients assessed for eligibility, of whom 452 patients were enrolled and 226', 'Between Jan 24, 2013, and Nov 7, 2016']","['brentuximab vedotin 1·8 mg/kg and a placebo form of vincristine intravenously (A+CHP group) or vincristine 1·4', 'Brentuximab vedotin with chemotherapy', 'placebo', 'A+CHP or CHOP', 'cyclophosphamide 750 mg/m 2  and doxorubicin', 'prednisone', 'A+CHP', 'brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone (A+CHP) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP']","['Adverse events, including incidence and severity of febrile neutropenia', 'hazard ratio 0·71', 'progression-free survival', 'progression-free survival and overall survival', 'peripheral neuropathy', 'efficacy and safety', 'Fatal adverse events', 'Median progression-free survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C3888910', 'cui_str': 'CD30 positive'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0206180', 'cui_str': 'CD30+ Anaplastic Large-Cell Lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",452.0,0.58496,Median progression-free survival was 48·2 months (95% CI 35·2-not evaluable) in the A+CHP group and 20·8 months (12·7-47·6) in the CHOP group (,"[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Horwitz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: horwitzs@mskcc.org.'}, {'ForeName': 'Owen A', 'Initials': 'OA', 'LastName': ""O'Connor"", 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pro', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Illidge', 'Affiliation': 'Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, National Institutes of Health and Research Biomedical Research Centre, Manchester Academic Health Sciences Centre, Christie Hospital National Health Service Foundation Trust, Manchester, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Fanale', 'Affiliation': 'MD Anderson Cancer Center, University of Texas, Houston, TX, USA; Seattle Genetics, Inc, Bothell, WA, USA.'}, {'ForeName': 'Ranjana', 'Initials': 'R', 'LastName': 'Advani', 'Affiliation': 'Stanford Cancer Center, Blood and Marrow Transplant Program, Stanford, CA, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Washington University School of Medicine, St Louis, MI, USA.'}, {'ForeName': 'Jacob Haaber', 'Initials': 'JH', 'LastName': 'Christensen', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morschhauser', 'Affiliation': 'University of Lille, Centre Hospitalier Universitaire de Lille, Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Domingo-Domenech', 'Affiliation': ""Institut Catala D'oncologia, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Rossi', 'Affiliation': 'Azienda Ospedaliera Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Won Seog', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Feldman', 'Affiliation': 'Hackensack University Medical Center, Hackensack, NJ, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lennard', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': '4th Department of Internal Medicine-Haematology, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.'}, {'ForeName': 'Árpád', 'Initials': 'Á', 'LastName': 'Illés', 'Affiliation': 'University of Debrecen, Faculty of Medicine, Department of Hematology, Debrecen, Hungary.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Tobinai', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Tsukasaki', 'Affiliation': 'Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Su-Peng', 'Initials': 'SP', 'LastName': 'Yeh', 'Affiliation': 'China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Shustov', 'Affiliation': 'University of Washington Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hüttmann', 'Affiliation': 'Universitatsklinikum Essen, Essen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Savage', 'Affiliation': 'University of British Columbia and the Department of Medical Oncology, British Columbia Cancer Centre for Lymphoid Cancer, Vancouver, BC, Canada.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Yuen', 'Affiliation': 'Calvary Mater Newcastle Hospital, Waratah, NSW, Australia.'}, {'ForeName': 'Swaminathan', 'Initials': 'S', 'LastName': 'Iyer', 'Affiliation': 'MD Anderson Cancer Center, University of Texas, Houston, TX, USA.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Institute of Hematology Seràgnoli, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Zhaowei', 'Initials': 'Z', 'LastName': 'Hua', 'Affiliation': 'Millennium Pharmaceuticals, Inc, Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Little', 'Affiliation': 'Millennium Pharmaceuticals, Inc, Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company.'}, {'ForeName': 'Shangbang', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Seattle Genetics, Inc, Bothell, WA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Woolery', 'Affiliation': 'Seattle Genetics, Inc, Bothell, WA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Manley', 'Affiliation': 'Seattle Genetics, Inc, Bothell, WA, USA.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Trümper', 'Affiliation': 'Universitätsmedizin Göttingen, Göttingen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(18)32984-2']
33,19014354,Desferroxamine infusion increases cerebral blood flow: a potential association with hypoxia-inducible factor-1.,"Finding an effective means to improve cerebral perfusion during hypoxic/ischaemic stress is essential for neuroprotection. Studies in animal models of stroke have shown that desferroxamine activates HIF-1 (hypoxia-inducible factor-1), reduces brain damage and promotes functional recovery. The present study was designed to investigate the effects of desferroxamine infusion on the cerebral circulation in humans. Fifteen volunteers were enrolled in a randomized double-blind placebo-controlled crossover study. We measured cerebral blood flow velocity by transcranial Doppler ultrasonography in the middle cerebral artery, arterial blood pressure, end-tidal CO(2), as well as HIF-1 protein and serum lactate dehydrogenase concentrations in response to 8 h of desferroxamine compared with placebo infusion. Cerebrovascular resistance was calculated from the ratio of steady-state beat-to-beat values for blood pressure to blood flow velocity. We found that desferroxamine infusion was associated with a significant cerebral vasodilation. Moreover, decreased cerebrovascular resistance was temporally correlated with an increased HIF-1 protein concentration as well as HIF-1 transcriptional activation, as measured by serum lactate dehydrogenase concentration. The findings of the present study provide preliminary data suggesting that activators of HIF-1, such as desferroxamine, may protect neurons against ischaemic injury by dilating cerebral vessels and enhancing cerebral perfusion.",2009,"Moreover, decreased cerebrovascular resistance was temporally correlated with an increased HIF-1 protein concentration as well as HIF-1 transcriptional activation, as measured by serum lactate dehydrogenase concentration.","['Fifteen volunteers', 'humans']","['desferroxamine infusion', 'desferroxamine', 'placebo', 'Desferroxamine infusion']","['serum lactate dehydrogenase concentration', 'cerebrovascular resistance', 'cerebral blood flow velocity by transcranial Doppler ultrasonography in the middle cerebral artery, arterial blood pressure, end-tidal CO(2', 'cerebral vasodilation', 'Cerebrovascular resistance', 'cerebral perfusion', 'HIF-1 protein and serum lactate dehydrogenase concentrations', 'cerebral blood flow', 'HIF-1 protein concentration']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0011145', 'cui_str': 'Deferoxamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1304757', 'cui_str': 'Finding of protein concentration, dipstick (finding)'}]",15.0,0.0703333,"Moreover, decreased cerebrovascular resistance was temporally correlated with an increased HIF-1 protein concentration as well as HIF-1 transcriptional activation, as measured by serum lactate dehydrogenase concentration.","[{'ForeName': 'Farzaneh A', 'Initials': 'FA', 'LastName': 'Sorond', 'Affiliation': ""Department of Neurology, Stroke Division, Brigham and Women's Hospital, Boston, MA 02115, USA. fsorond@partners.org""}, {'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Shaffer', 'Affiliation': ''}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Kung', 'Affiliation': ''}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': ''}]","Clinical science (London, England : 1979)",['10.1042/CS20080320']
34,31454725,Results from a Phase 1 Study of Sodium Selenite in Combination with Palliative Radiation Therapy in Patients with Metastatic Cancer.,"In preclinical studies, selenite had single agent activity and radiosensitized tumors in vivo. Here we report results from a Phase 1 trial in 15 patients with metastatic cancer treated with selenite (5.5 to 49.5 mg) orally as a single dose 2 hours before each radiation therapy (RT) treatment. Patients received RT regimens that were standard of care. The primary objective of the study was to assess the safety of this combination therapy. Secondary objectives included measurement of pharmacokinetics (PK) and evaluation of efficacy. Endpoints included assessment of PK, toxicity, tumor response, and pain before and after treatment. The half-life of selenite was 18.5 hours. There were no adverse events attributable to selenite until the 33 mg dose level, at which the primary toxicities were grade 1 GI side effects. One patient treated with 49.5 mg had grade 2 GI toxicity. Although this was not a DLT, it was felt that the highest acceptable dose in this patient population was 33 mg. Most patients had stabilization of disease within the RT fields, with some demonstrating objective evidence of tumor regression. Most patients had a marked improvement in pain and seven out of nine patients with prostate cancer had a decrease in PSA ranging from 11-78%. Doses up to 33 mg selenite were well tolerated in combination with RT. A randomized, well controlled study is needed at the 33 mg dose level to determine if selenite results in clinically meaningful improvements in the response to palliative RT.",2019,"There were no adverse events attributable to selenite until the 33 mg dose level, at which the primary toxicities were grade 1 GI side effects.","['Patients with Metastatic Cancer', '15 patients with metastatic cancer treated with']","['Palliative Radiation Therapy', 'selenite', 'radiation therapy (RT) treatment', 'Sodium Selenite']","['pain', 'measurement of pharmacokinetics (PK) and evaluation of efficacy', 'grade 2 GI toxicity', 'assessment of PK, toxicity, tumor response, and pain', 'PSA', 'tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939419', 'cui_str': 'Metastatic cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0036580', 'cui_str': 'Selenite'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0142923', 'cui_str': 'Sodium Selenite'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]",,0.0599429,"There were no adverse events attributable to selenite until the 33 mg dose level, at which the primary toxicities were grade 1 GI side effects.","[{'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Knox', 'Affiliation': 'Department of Radiation Oncology, Stanford University, Stanford, CA. Electronic address: sknox@stanford.edu.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Jayachandran', 'Affiliation': 'Department of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Keeling', 'Affiliation': 'Departments of Diagnostic Radiology, Stanford University, Stanford, CA.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Stevens', 'Affiliation': 'Departments of Diagnostic Radiology, Stanford University, Stanford, CA.'}, {'ForeName': 'Navjot', 'Initials': 'N', 'LastName': 'Sandhu', 'Affiliation': 'Department of Radiation Oncology, Stanford University, Stanford, CA.'}, {'ForeName': 'Stacy Leanne', 'Initials': 'SL', 'LastName': 'Stamps-DeAnda', 'Affiliation': 'Department of Radiation Oncology, Stanford University, Stanford, CA.'}, {'ForeName': 'Rada', 'Initials': 'R', 'LastName': 'Savic', 'Affiliation': 'Department of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shura', 'Affiliation': 'Department of Radiation Oncology, Stanford University, Stanford, CA.'}, {'ForeName': 'Mark K', 'Initials': 'MK', 'LastName': 'Buyyounouski', 'Affiliation': 'Department of Radiation Oncology, Stanford University, Stanford, CA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Grimes', 'Affiliation': 'Chemical and Systems Biology, Stanford University, Stanford, CA.'}]",Translational oncology,['10.1016/j.tranon.2019.08.006']
35,30337315,Protocol for a gender-sensitised weight loss and healthy living programme for overweight and obese men delivered in Australian football league settings (Aussie-FIT): A feasibility and pilot randomised controlled trial.,"INTRODUCTION


Overweight and obesity are highly prevalent among Australian men. Professional sports settings can act as a powerful 'hook' to engage men in weight loss programmes; the Football Fans in Training programme delivered in professional UK soccer clubs was successful and cost-effective in helping men lose weight. The Australian Football League (AFL) is a potentially attractive setting to engage men in a weight loss programme. We aim to develop, pilot and evaluate the feasibility of a weight loss intervention for overweight/obese middle-aged men, delivered in AFL settings, to promote weight loss and healthier lifestyles and determine its suitability for a future randomised control trial.
METHODS AND ANALYSIS


120 overweight/obese male fans will complete baseline physical and psychological health measures and objective measures of physical activity (PA), weight, waist size and blood pressure prior to randomisation into the intervention or waitlist comparison group. The intervention group will receive 12 weekly 90 min workshops incorporating PA, nutrition education, behaviour change techniques and principles of effective motivation. Four community coaches will be trained to deliver Aussie-FIT at two AFL clubs in Western Australia. Measurements will be repeated in both groups at 3 months (post-intervention) and 6 months (follow-up). Outcomes will include programme uptake, attendance, changes in lifestyle and weight variables to inform power calculations for a future definitive trial, fidelity of programme delivery, acceptability, satisfaction with the programme and perceptions of effectiveness. We will also determine trial feasibility and potential to gather cost-effectiveness data.
ETHICS AND DISSEMINATION


Ethics approval was granted by Curtin University's Human Research Ethics Committee (HREC2017-0458). Results will be disseminated via peer-reviewed publications, conference presentations and reports. A multicomponent dissemination strategy will include targeted translation and stakeholder engagement events to establish strategies for sustainability and policy change.
TRIAL REGISTRATION NUMBER


ACTRN12617000515392; Pre-results.",2018,Professional sports settings can act as a powerful 'hook' to engage men in weight loss programmes; the Football Fans in Training programme delivered in professional UK soccer clubs was successful and cost-effective in helping men lose weight.,"['overweight and obese men delivered in Australian football league settings (Aussie-FIT', 'overweight/obese middle-aged men', '120 overweight/obese male fans will']","['healthy living programme', 'weight loss intervention']","['programme uptake, attendance, changes in lifestyle and weight variables to inform power calculations for a future definitive trial, fidelity of programme delivery, acceptability, satisfaction with the programme and perceptions of effectiveness', 'complete baseline physical and psychological health measures and objective measures of physical activity (PA), weight, waist size and blood pressure']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0441039', 'cui_str': 'Fan (physical object)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",4.0,0.0781028,Professional sports settings can act as a powerful 'hook' to engage men in weight loss programmes; the Football Fans in Training programme delivered in professional UK soccer clubs was successful and cost-effective in helping men lose weight.,"[{'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Quested', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Kwasnicka', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Thøgersen-Ntoumani', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Gucciardi', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Kerr', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hunt', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'Priority Research Centre in Physical Activity and Nutrition, School of Education, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'Exercise Medicine Research Institute, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Well-being, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Institute of Health and Well-being, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'McVeigh', 'Affiliation': 'Movement Physiology Laboratory, School of Physiology, University of Witwatersrand, Witwatersrand, South Africa.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Malacova', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2018-022663']
36,31983312,"Orthostatic Hypotension, Cardiovascular Outcomes, and Adverse Events: Results From SPRINT.","Orthostatic hypotension (OH) is frequently observed with hypertension treatment, but its contribution to adverse outcomes is unknown. The SPRINT (Systolic Blood Pressure Intervention Trial) was a randomized trial of adults, age ≥50 years at high risk for cardiovascular disease with a seated systolic blood pressure (BP) of 130 to 180 mm Hg and a standing systolic BP ≥110 mm Hg. Participants were randomized to a systolic BP treatment goal of either <120 or <140 mm Hg. OH was defined as a drop in systolic BP ≥20 or diastolic BP ≥10 mm Hg 1 minute after standing from a seated position. We used Cox models to examine the association of OH with cardiovascular disease or adverse study events by randomized BP goal. During the follow-up period (median 3years), there were 1170 (5.7%) instances of OH among those assigned a standard BP goal and 1057 (5.0%) among those assigned the intensive BP goal. OH was not associated with higher risk of cardiovascular disease events (primary outcome: hazard ratio 1.06 [95% CI, 0.78-1.44]). Moreover, OH was not associated with syncope, electrolyte abnormalities, injurious falls, or acute renal failure. OH was associated with hypotension-related hospitalizations or emergency department visits (hazard ratio, 1.77 [95% CI, 1.11-2.82]) and bradycardia (hazard ratio, 1.94 [95% CI, 1.19-3.15]), but these associations did not differ by BP treatment goal. OH was not associated with a higher risk of cardiovascular disease events, and BP treatment goal had no effect on OH's association with hypotension and bradycardia. Symptomless OH during hypertension treatment should not be viewed as a reason to down-titrate therapy even in the setting of a lower BP goal. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT01206062.",2020,"OH was associated with hypotension-related hospitalizations or emergency department visits (hazard ratio, 1.77 [95% CI, 1.11-2.82]) and bradycardia (hazard ratio, 1.94","['adults, age ≥50 years at high risk for cardiovascular disease with a seated systolic blood pressure (BP) of 130 to 180 mm Hg and a standing systolic BP ≥110 mm Hg']",[],"['syncope, electrolyte abnormalities, injurious falls, or acute renal failure', 'Orthostatic Hypotension, Cardiovascular Outcomes, and Adverse Events', 'Orthostatic hypotension (OH', 'systolic BP ≥20 or diastolic BP ≥10 mm', 'hypotension-related hospitalizations or emergency department visits', 'bradycardia', 'cardiovascular disease events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",[],"[{'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0151613', 'cui_str': 'Electrolytes abnormal (finding)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C3854173', 'cui_str': 'Pre-renal acute kidney injury'}, {'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.211047,"OH was associated with hypotension-related hospitalizations or emergency department visits (hazard ratio, 1.77 [95% CI, 1.11-2.82]) and bradycardia (hazard ratio, 1.94","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'From the Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (S.P.J.).'}, {'ForeName': 'Addison A', 'Initials': 'AA', 'LastName': 'Taylor', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center and Department of Medicine, Baylor College of Medicine, Houston, TX (A.A.T.).'}, {'ForeName': 'Jackson T', 'Initials': 'JT', 'LastName': 'Wright', 'Affiliation': 'Department of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH (J.T.W.).'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Evans', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC (G.W.E.).'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, MD (E.R.M., L.J.A.).'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Plante', 'Affiliation': 'Larner College of Medicine at The University of Vermont, Burlington (T.B.P.).'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Preventive Medicine Section, Memphis VA Medical Center, Memphis, TN (W.C.C.).'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Gure', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Department of Internal Medicine, The Ohio State University, Columbus (T.R.G.).'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Jacksonville, FL (W.E.H.).'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Moinuddin', 'Affiliation': 'Department of Medicine, University of Illinois at Chicago, College of Medicine, IL (I.M.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nord', 'Affiliation': 'Department of Internal Medicine; Salt Lake City VA Medical Center, UT (J.N.).'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Division of Cardiovascular Disease, Department of Medicine, University of Alabama at Birmingham (S.O.).'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Pedley', 'Affiliation': 'Department of Internal Medicine, Wake Forest Baptist Medical Center, Winston-Salem, NC (C.P.).'}, {'ForeName': 'Christianne L', 'Initials': 'CL', 'LastName': 'Roumie', 'Affiliation': 'Institute for Medicine and Public Health, Vanderbilt University Medical Center, VA Geriatric Research Education and Clinical Center, Nashville, TN (C.L.R.).'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Whittle', 'Affiliation': 'Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Wiggers', 'Affiliation': 'Department of Primary Care, Ohio University Heritage College of Osteopathic Medicine, Cleveland (A.W.).'}, {'ForeName': 'Ciarán', 'Initials': 'C', 'LastName': 'Finucane', 'Affiliation': ""Department of Medical Physics, Mercer's Institute for Successful Ageing, St James's Hospital, Dublin, Ireland (C.F.).""}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Anne Kenny', 'Affiliation': ""Mercer's Institute for Successful Ageing, St James's Hospital, Dublin, Ireland (R.A.K.).""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, MD (E.R.M., L.J.A.).'}, {'ForeName': 'Raymond R', 'Initials': 'RR', 'LastName': 'Townsend', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania (R.R.T.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.14309']
37,30759035,Very-low-dose twice-daily aspirin maintains platelet inhibition and improves haemostasis during dual-antiplatelet therapy for acute coronary syndrome.,"Higher aspirin doses may be inferior in ticagrelor-treated acute coronary syndrome (ACS) patients and reducing bleeding risk whilst maintaining antithrombotic benefits could improve outcomes. We characterized the pharmacodynamics of a novel dual-antiplatelet-therapy regimen consisting of very-low-dose twice-daily (BD) aspirin with standard-dose ticagrelor. A total of 20 ticagrelor-treated ACS patients entered a randomized crossover to take aspirin 20 mg BD (12-hourly) during one 14-day period and 75 mg once-daily (OD) in the other. After 14 days of treatment, serum thromboxane (TX)B 2  and light-transmittance aggregometry were assessed pre- and 2 h post-morning-dose, bleeding time was measured post-dose, and TXA 2  and prostacyclin stable metabolites were measured in urine collected 2 h post-morning-dose. Data are expressed as mean ± SD. After 14 days treatment, serum TXB 2  levels were significantly greater 2 h post-dosing with aspirin 20 mg BD vs. 75 mg OD (3.0 ± 3.6 ng/mL vs. 0.8 ± 1.9 ng/mL; p = 0.018) whereas pre-dosing levels were not significantly different (3.5 ± 4.1 ng/mL vs. 2.5 ± 3.1 ng/mL, p = 0.23). 1-mmol/L arachidonic acid-induced platelet aggregation was similarly inhibited by both regimens pre-dose (8.5 ± 14.3% vs. 5.1 ± 3.6%, p = 0.24) and post-dose (8.7 ± 14.2% vs. 6.6 ± 5.3%; p = 0.41). Post-dose bleeding time was shorter with 20 mg BD (680 ± 306 s vs. 834 ± 386 s, p = 0.02). Urinary prostacyclin and TX metabolite excretion were not significantly different. In conclusion, compared to aspirin 75 mg OD, aspirin 20 mg BD provided consistent inhibition of platelet TXA 2  release and aggregation, and improved post-dose hemostasis, in ticagrelor-treated ACS patients. Further studies are warranted to assess whether this regimen improves the balance of clinical efficacy and safety.",2019,"Post-dose bleeding time was shorter with 20 mg BD (680 ± 306 s vs. 834 ± 386 s, p = 0.02).","['acute coronary syndrome', 'A total of 20 ticagrelor-treated ACS patients']","['aspirin 20 mg BD', 'aspirin', 'very-low-dose twice-daily (BD) aspirin with standard-dose ticagrelor']","['balance of clinical efficacy and safety', 'serum TXB 2  levels', 'serum thromboxane (TX)B 2  and light-transmittance aggregometry', 'haemostasis', '1-mmol/L arachidonic acid-induced platelet aggregation', 'TXA 2  and prostacyclin stable metabolites', 'bleeding time', 'Urinary prostacyclin and TX metabolite excretion']","[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0040061', 'cui_str': 'Thromboxanes'}, {'cui': 'C0045550', 'cui_str': 'sodium 2,5-dichloro-4-bromophenol'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C1268820', 'cui_str': 'Arachidonic acid induced platelet aggregation'}, {'cui': 'C0205911', 'cui_str': 'Prostaglandins I'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005729', 'cui_str': 'Bleeding Time'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}]",,0.0417603,"Post-dose bleeding time was shorter with 20 mg BD (680 ± 306 s vs. 834 ± 386 s, p = 0.02).","[{'ForeName': 'William A E', 'Initials': 'WAE', 'LastName': 'Parker', 'Affiliation': 'a Department of Infection, Immunity and Cardiovascular Disease , University of Sheffield , Sheffield , United Kingdom.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Orme', 'Affiliation': 'a Department of Infection, Immunity and Cardiovascular Disease , University of Sheffield , Sheffield , United Kingdom.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hanson', 'Affiliation': 'a Department of Infection, Immunity and Cardiovascular Disease , University of Sheffield , Sheffield , United Kingdom.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Stokes', 'Affiliation': 'a Department of Infection, Immunity and Cardiovascular Disease , University of Sheffield , Sheffield , United Kingdom.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Bridge', 'Affiliation': 'a Department of Infection, Immunity and Cardiovascular Disease , University of Sheffield , Sheffield , United Kingdom.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Shaw', 'Affiliation': 'a Department of Infection, Immunity and Cardiovascular Disease , University of Sheffield , Sheffield , United Kingdom.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Sumaya', 'Affiliation': 'a Department of Infection, Immunity and Cardiovascular Disease , University of Sheffield , Sheffield , United Kingdom.'}, {'ForeName': 'Kirstie', 'Initials': 'K', 'LastName': 'Thorneycroft', 'Affiliation': 'a Department of Infection, Immunity and Cardiovascular Disease , University of Sheffield , Sheffield , United Kingdom.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Petrucci', 'Affiliation': 'c Institute of Pharmacology , Catholic University School of Medicine , Rome , Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Porro', 'Affiliation': 'd Centro Cardiologico Monzino , Istituto di Ricovero e Cura a Carattere Scientifico Cardiologico Monzino , Milan , Italy.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Judge', 'Affiliation': 'a Department of Infection, Immunity and Cardiovascular Disease , University of Sheffield , Sheffield , United Kingdom.'}, {'ForeName': 'Ramzi A', 'Initials': 'RA', 'LastName': 'Ajjan', 'Affiliation': 'e Leeds Institute of Cardiovascular and Metabolic Medicine , University of Leeds , Leeds , UK.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Rocca', 'Affiliation': 'c Institute of Pharmacology , Catholic University School of Medicine , Rome , Italy.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'a Department of Infection, Immunity and Cardiovascular Disease , University of Sheffield , Sheffield , United Kingdom.'}]",Platelets,['10.1080/09537104.2019.1572880']
38,31043522,A randomized placebo-controlled pilot trial shows that intranasal vasopressin improves social deficits in children with autism.,"The social impairments of autism spectrum disorder (ASD) have a major impact on quality of life, yet there are no medications that effectively treat these core social behavior deficits. Preclinical research suggests that arginine vasopressin (AVP), a neuropeptide involved in promoting mammalian social behaviors, may be a possible treatment for ASD. Using a double-blind, randomized, placebo-controlled, parallel study design, we tested the efficacy and tolerability of a 4-week intranasal AVP daily treatment in 30 children with ASD. AVP-treated participants aged 6 to 9.5 years received the maximum daily target dose of 24 International Units (IU); participants aged 9.6 to 12.9 years received the maximum daily target dose of 32 IU. Intranasal AVP treatment compared to placebo enhanced social abilities as assessed by change from baseline in this phase 2 trial's primary outcome measure, the Social Responsiveness Scale, 2nd Edition total score (SRS-2  T  score;  F   1,20  = 9.853;  P  = 0.0052; η p   2  = 33.0%; Cohen's  d  = 1.40). AVP treatment also diminished anxiety symptoms and some repetitive behaviors. Most of these findings were more pronounced when we accounted for pretreatment AVP concentrations in blood. AVP was well tolerated with minimal side effects. No AVP-treated participants dropped out of the trial, and there were no differences in the rate of adverse events reported between treatment conditions. Last, no changes from baseline were observed in vital signs, electrocardiogram tracings, height and body weight, or clinical chemistry measurements after 4 weeks of AVP treatment. These preliminary findings suggest that AVP has potential for treating social impairments in children with ASD.",2019,"No AVP-treated participants dropped out of the trial, and there were no differences in the rate of adverse events reported between treatment conditions.","['children with ASD', 'children with autism', 'AVP-treated participants aged 6 to 9.5 years received the maximum daily target dose of 24 International Units (IU); participants aged 9.6 to 12.9 years', 'autism spectrum disorder (ASD', '30 children with ASD']","['intranasal AVP', 'arginine vasopressin (AVP', 'AVP', 'intranasal vasopressin', 'placebo', 'Intranasal AVP']","['anxiety symptoms and some repetitive behaviors', 'vital signs, electrocardiogram tracings, height and body weight, or clinical chemistry measurements', 'social abilities', 'social deficits', 'Social Responsiveness Scale, 2nd Edition total score', 'efficacy and tolerability', 'rate of adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439453', 'cui_str': 'IU'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0201849', 'cui_str': 'Antidiuretic hormone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0008000', 'cui_str': 'Chemistry, Clinical'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0222045'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",30.0,0.467857,"No AVP-treated participants dropped out of the trial, and there were no differences in the rate of adverse events reported between treatment conditions.","[{'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Parker', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA. kjparker@stanford.edu.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Oztan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Robin A', 'Initials': 'RA', 'LastName': 'Libove', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Noreen', 'Initials': 'N', 'LastName': 'Mohsin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Debra S', 'Initials': 'DS', 'LastName': 'Karhson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Raena D', 'Initials': 'RD', 'LastName': 'Sumiyoshi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Jacqueline E', 'Initials': 'JE', 'LastName': 'Summers', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Kyle E', 'Initials': 'KE', 'LastName': 'Hinman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Kara S', 'Initials': 'KS', 'LastName': 'Motonaga', 'Affiliation': 'Department of Pediatrics, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Dean S', 'Initials': 'DS', 'LastName': 'Carson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Lawrence K', 'Initials': 'LK', 'LastName': 'Fung', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Garner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Antonio Y', 'Initials': 'AY', 'LastName': 'Hardan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, USA.'}]",Science translational medicine,['10.1126/scitranslmed.aau7356']
39,30721231,The effect of a programme to improve men's sedentary time and physical activity: The European Fans in Training (EuroFIT) randomised controlled trial.,"BACKGROUND


Reducing sitting time as well as increasing physical activity in inactive people is beneficial for their health. This paper investigates the effectiveness of the European Fans in Training (EuroFIT) programme to improve physical activity and sedentary time in male football fans, delivered through the professional football setting.
METHODS AND FINDINGS


A total of 1,113 men aged 30-65 with self-reported body mass index (BMI) ≥27 kg/m2 took part in a randomised controlled trial in 15 professional football clubs in England, the Netherlands, Norway, and Portugal. Recruitment was between September 19, 2015, and February 2, 2016. Participants consented to study procedures and provided usable activity monitor baseline data. They were randomised, stratified by club, to either the EuroFIT intervention or a 12-month waiting list comparison group. Follow-up measurement was post-programme and 12 months after baseline. EuroFIT is a 12-week, group-based programme delivered by coaches in football club stadia in 12 weekly 90-minute sessions. Weekly sessions aimed to improve physical activity, sedentary time, and diet and maintain changes long term. A pocket-worn device (SitFIT) allowed self-monitoring of sedentary time and daily steps, and a game-based app (MatchFIT) encouraged between-session social support. Primary outcome (objectively measured sedentary time and physical activity) measurements were obtained for 83% and 85% of intervention and comparison participants. Intention-to-treat analyses showed a baseline-adjusted mean difference in sedentary time at 12 months of -1.6 minutes/day (97.5% confidence interval [CI], -14.3-11.0; p = 0.77) and in step counts of 678 steps/day (97.5% CI, 309-1.048; p < 0.001) in favor of the intervention. There were significant improvements in diet, weight, well-being, self-esteem, vitality, and biomarkers of cardiometabolic health in favor of the intervention group, but not in quality of life. There was a 0.95 probability of EuroFIT being cost-effective compared with the comparison group if society is willing to pay £1.50 per extra step/day, a maximum probability of 0.61 if society is willing to pay £1,800 per minute less sedentary time/day, and 0.13 probability if society is willing to pay £30,000 per quality-adjusted life-year (QALY). It was not possible to blind participants to group allocation. Men attracted to the programme already had quite high levels of physical activity at baseline (8,372 steps/day), which may have limited room for improvement. Although participants came from across the socioeconomic spectrum, a majority were well educated and in paid work. There was an increase in recent injuries and in upper and lower joint pain scores post-programme. In addition, although the five-level EuroQoL questionnaire (EQ-5D-5L) is now the preferred measure for cost-effectiveness analyses across Europe, baseline scores were high (0.93), suggesting a ceiling effect for QALYs.
CONCLUSION


Participation in EuroFIT led to improvements in physical activity, diet, body weight, and biomarkers of cardiometabolic health, but not in sedentary time at 12 months. Within-trial analysis suggests it is not cost-effective in the short term for QALYs due to a ceiling effect in quality of life. Nevertheless, decision-makers may consider the incremental cost for increase in steps worth the investment.
TRIAL REGISTRATION


International Standard Randomised Controlled Trials, ISRCTN-81935608.",2019,Within-trial analysis suggests it is not cost-effective in the short term for QALYs due to a ceiling effect in quality of life.,"['1,113 men aged 30-65 with self-reported body mass index', '15 professional football clubs in England, the Netherlands, Norway, and Portugal']","['European Fans in Training (EuroFIT) programme', 'EuroFIT intervention or a 12-month waiting list comparison group', 'pocket-worn device (SitFIT) allowed self-monitoring of sedentary time and daily steps, and a game-based app (MatchFIT', 'EuroFIT']","['physical activity, sedentary time, and diet and maintain changes long term', 'recent injuries and in upper and lower joint pain scores', 'physical activity, diet, body weight, and biomarkers of cardiometabolic health', 'sedentary time', 'physical activity and sedentary time', 'diet, weight, well-being, self-esteem, vitality, and biomarkers of cardiometabolic health', 'sedentary time and physical activity) measurements', 'quality of life', ""men's sedentary time and physical activity""]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0032729', 'cui_str': 'Portuguese Republic'}]","[{'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0441039', 'cui_str': 'Fan (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0332665', 'cui_str': 'Recent injury (morphologic abnormality)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0034380'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",1113.0,0.118737,Within-trial analysis suggests it is not cost-effective in the short term for QALYs due to a ceiling effect in quality of life.,"[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bunn', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Andersen', 'Affiliation': 'Department of Coaching and Psychology, Norwegian School of Sport Science, Oslo, Norway.'}, {'ForeName': 'Marlene N', 'Initials': 'MN', 'LastName': 'Silva', 'Affiliation': 'Interdisciplinary Center for the Study of Human Performance (CIPER), Faculty of Human Kinetics, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'van Nassau', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'McSkimming', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Kolovos', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jason M R', 'Initials': 'JMR', 'LastName': 'Gill', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hunt', 'Affiliation': 'Institute for Social Marketing, University of Stirling, Stirling, United Kingdom.'}, {'ForeName': 'Annie S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Centre for Public Health Nutrition Research, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Judith G M', 'Initials': 'JGM', 'LastName': 'Jelsma', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Kean', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Lemyre', 'Affiliation': 'Department of Coaching and Psychology, Norwegian School of Sport Science, Oslo, Norway.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Loudon', 'Affiliation': 'PAL Technologies Ltd., Glasgow, United Kingdom.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Macaulay', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Maxwell', 'Affiliation': 'PAL Technologies Ltd., Glasgow, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Mutrie', 'Affiliation': 'Physical Activity for Health Research Centre, the University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Nijhuis-van der Sanden', 'Affiliation': 'Radboud University Medical Center, Radboud Institute for Health Sciences, Scientific Center for Quality of Healthcare, Nijmegen, the Netherlands.'}, {'ForeName': 'Hugo V', 'Initials': 'HV', 'LastName': 'Pereira', 'Affiliation': 'Interdisciplinary Center for the Study of Human Performance (CIPER), Faculty of Human Kinetics, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Philpott', 'Affiliation': 'European Healthy Stadia Network CIC Ltd., Liverpool, United Kingdom.'}, {'ForeName': 'Glyn C', 'Initials': 'GC', 'LastName': 'Roberts', 'Affiliation': 'Department of Coaching and Psychology, Norwegian School of Sport Science, Oslo, Norway.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rooksby', 'Affiliation': 'Computer and Information Sciences, Northumbria University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Øystein B', 'Initials': 'ØB', 'LastName': 'Røynesdal', 'Affiliation': 'Department of Coaching and Psychology, Norwegian School of Sport Science, Oslo, Norway.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Sørensen', 'Affiliation': 'Department of Coaching and Psychology, Norwegian School of Sport Science, Oslo, Norway.'}, {'ForeName': 'Pedro J', 'Initials': 'PJ', 'LastName': 'Teixeira', 'Affiliation': 'Interdisciplinary Center for the Study of Human Performance (CIPER), Faculty of Human Kinetics, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Treweek', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'van Achterberg', 'Affiliation': 'KU Leuven, Department of Public Health and Primary Care, Leuven, Belgium.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'van de Glind', 'Affiliation': 'Radboud University Medical Center, Radboud Institute for Health Sciences, Scientific Center for Quality of Healthcare, Nijmegen, the Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'van Mechelen', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Hidde P', 'Initials': 'HP', 'LastName': 'van der Ploeg', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}]",PLoS medicine,['10.1371/journal.pmed.1002736']
40,29459111,A Trial of Two Anesthetic Regimes for Minimally Invasive Mitral Valve Repair.,"OBJECTIVE


Minimally invasive mitral valve repair may be associated with prolonged cardioplegic arrest times and ischemic reperfusion injury. Intravenous (propofol) and volatile (sevoflurane) anesthesia are used routinely during cardiac surgery and are thought to provide cardioprotection; however, the individual contribution of each regimen to cardioprotection is unknown. Therefore, the authors sought to compare the cardioprotective effects of propofol and sevoflurane anesthesia in patients undergoing minimally invasive mitral valve repair.
DESIGN


A single-center single-blind randomized controlled trial.
SETTING


A specialized regional cardiac surgery center in Italy.
PARTICIPANTS


The study enrolled 62 adults undergoing elective isolated minimally invasive mitral valve repair for degenerative disease. Exclusion criteria included secondary mitral regurgitation, previously treated coronary artery disease, diabetes mellitus, chronic renal failure requiring dialysis, atrial fibrillation, and documented allergy to either propofol or sevoflurane.
INTERVENTIONS


All patients received video-assisted minimally invasive right minithoracotomy. Patients were randomized to receive propofol or sevoflurane anesthesia in a 1:1 ratio.
MEASUREMENTS AND MAIN RESULTS


Cardiac troponin I release was measured over the first 72 hours postoperatively. Operative, cross-clamp, and total bypass times were similar between groups. Cardiac troponin I release was reduced nonsignificantly in the propofol group (p = 0.62), and peak troponin I release was correlated with cross-clamp time in both groups. There were no differences in terms of intraoperative lactate release and blood pH between groups.
CONCLUSION


Propofol and sevoflurane anesthesia were associated with similar degrees of myocardial injury, indicating comparable cardioprotection. Myocardial injury was related directly to the duration of cardioplegic arrest.",2018,"I release was reduced nonsignificantly in the propofol group (p = 0.62), and peak troponin I release was correlated with cross-clamp time in both groups.","['Minimally Invasive Mitral Valve Repair', 'Exclusion criteria included secondary mitral regurgitation, previously treated coronary artery disease, diabetes mellitus, chronic renal failure requiring dialysis, atrial fibrillation, and documented allergy to either propofol or sevoflurane', 'The study enrolled 62 adults undergoing elective isolated minimally invasive mitral valve repair for degenerative disease', 'patients undergoing minimally invasive mitral valve repair', 'A specialized regional cardiac surgery center in Italy']","['sevoflurane anesthesia', 'video-assisted minimally invasive right minithoracotomy', 'propofol', 'propofol or sevoflurane anesthesia', 'Intravenous (propofol) and volatile (sevoflurane) anesthesia', 'Propofol', 'Cardiac troponin']","['Operative, cross-clamp, and total bypass times', 'cardioprotective effects', 'intraoperative lactate release and blood pH', 'peak troponin I release']","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0396849', 'cui_str': 'Repair of mitral valve (procedure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0026266', 'cui_str': 'Mitral Incompetence'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0405917', 'cui_str': 'Minithoracotomy (procedure)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1963547', 'cui_str': 'Volatile'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]","[{'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}]",62.0,0.108577,"I release was reduced nonsignificantly in the propofol group (p = 0.62), and peak troponin I release was correlated with cross-clamp time in both groups.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moscarelli', 'Affiliation': 'GVM Care & Research, Anthea Hospital, Bari, Italy. Electronic address: m.moscarelli@imperial.ac.uk.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Terrasini', 'Affiliation': 'Operative Unit of Anesthesiology, G. Pasquinucci Heart Hospital, Fondazione Toscana G. Monasterio, Massa, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nunziata', 'Affiliation': 'Operative Unit of Anesthesiology, G. Pasquinucci Heart Hospital, Fondazione Toscana G. Monasterio, Massa, Italy.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Punjabi', 'Affiliation': 'Imperial College of London, Hammersmith Hospital, London, UK.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Angelini', 'Affiliation': 'Bristol Heart Institute, University of Bristol, School of Clinical Sciences, Bristol, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Solinas', 'Affiliation': 'Operative Unit of Cardiac Surgery, G. Pasquinucci Heart Hospital, Fondazione Toscana G. Monasterio, Massa, Italy.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Buselli', 'Affiliation': 'Perfusion Department, G. Pasquinucci Heart Hospital, Fondazione Toscana G. Monasterio, Massa, Italy.'}, {'ForeName': 'Paolo Del', 'Initials': 'PD', 'LastName': 'Sarto', 'Affiliation': 'Operative Unit of Anesthesiology, G. Pasquinucci Heart Hospital, Fondazione Toscana G. Monasterio, Massa, Italy.'}, {'ForeName': 'Dorela', 'Initials': 'D', 'LastName': 'Haxhiademi', 'Affiliation': 'Operative Unit of Anesthesiology, G. Pasquinucci Heart Hospital, Fondazione Toscana G. Monasterio, Massa, Italy.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2018.01.028']
41,29673306,Depressive Symptoms Moderate Dating Violence Prevention Outcomes Among Adolescent Girls.,"Purpose:  Few dating violence prevention programs assess how variations in initial violence risk affects responsiveness. This study examines the efficacy of Date SMART, a dating violence and sexual risk prevention program designed to target high-risk adolescent girls, in preventing dating violence in the context of varying initial levels of depressive symptoms.  Method:  A diverse sample of  N  = 109 female adolescents with a history of physical dating violence participated in a randomized controlled trial of the Date SMART program and a knowledge only (KO) comparison.  Results:  Using baseline depression level as a primary risk factor, a series of multilevel models revealed significant main effects of baseline depression such that higher baseline depression was associated with greater physical dating violence perpetration and victimization. Results also showed a three-way interaction for assessment point, depressive symptoms, and condition for physical dating violence perpetration. Specifically, those with higher baseline depression in Date SMART showed significantly less physical dating violence perpetration at follow-ups compared with those with higher baseline depression in the KO group. This difference in violence reduction between conditions was not observed for those with lower baseline depression.  Discussion:  Date SMART appears to effectively reduce physical dating violence perpetration in those with higher levels of initial risk. Current findings support that adolescents with different risk profiles respond differently to violence prevention programs.",2021,"Results also showed a three-way interaction for assessment point, depressive symptoms, and condition for physical dating violence perpetration.","['Adolescent Girls', 'A diverse sample of N = 109 female adolescents with a history of physical dating violence', 'risk adolescent girls']",['Date SMART program and a knowledge only (KO) comparison'],"['Depressive Symptoms Moderate Dating Violence Prevention Outcomes', 'assessment point, depressive symptoms, and condition for physical dating violence perpetration', 'physical dating violence perpetration', 'baseline depression', 'violence reduction']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",109.0,0.0234464,"Results also showed a three-way interaction for assessment point, depressive symptoms, and condition for physical dating violence perpetration.","[{'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Collibee', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Christie J', 'Initials': 'CJ', 'LastName': 'Rizzo', 'Affiliation': 'Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kemp', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hood', 'Affiliation': 'Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Doucette', 'Affiliation': 'Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Gittins Stone', 'Affiliation': 'Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'DeJesus', 'Affiliation': 'Rhode Island Hospital, Providence, RI, USA.'}]",Journal of interpersonal violence,['10.1177/0886260518770189']
42,32186326,Long-term dietary intervention reveals resilience of the gut microbiota despite changes in diet and weight.,"BACKGROUND


With the rising rates of obesity and associated metabolic disorders, there is a growing need for effective long-term weight-loss strategies, coupled with an understanding of how they interface with human physiology. Interest is growing in the potential role of gut microbes as they pertain to responses to different weight-loss diets; however, the ways that diet, the gut microbiota, and long-term weight loss influence one another is not well understood.
OBJECTIVES


Our primary objective was to determine if baseline microbiota composition or diversity was associated with weight-loss success. A secondary objective was to track the longitudinal associations of changes to lower-carbohydrate or lower-fat diets and concomitant weight loss with the composition and diversity of the gut microbiota.
METHODS


We used 16S ribosomal RNA gene amplicon sequencing to profile microbiota composition over a 12-mo period in 49 participants as part of a larger randomized dietary intervention study of participants consuming either a healthy low-carbohydrate or a healthy low-fat diet.
RESULTS


While baseline microbiota composition was not predictive of weight loss, each diet resulted in substantial changes in the microbiota 3-mo after the start of the intervention; some of these changes were diet specific (14 taxonomic changes specific to the healthy low-carbohydrate diet, 12 taxonomic changes specific to the healthy low-fat diet) and others tracked with weight loss (7 taxonomic changes in both diets). After these initial shifts, the microbiota returned near its original baseline state for the remainder of the intervention, despite participants maintaining their diet and weight loss for the entire study.
CONCLUSIONS


These results suggest a resilience to perturbation of the microbiota's starting profile. When considering the established contribution of obesity-associated microbiotas to weight gain in animal models, microbiota resilience may need to be overcome for long-term alterations to human physiology. This trial was registered at clinicaltrials.gov as NCT01826591.",2020,"We used 16S ribosomal RNA gene amplicon sequencing to profile microbiota composition over a 12-mo period in 49 participants as part of a larger randomized dietary intervention study of participants consuming either a healthy low-carbohydrate or a healthy low-fat diet.
",['49 participants as part of a larger randomized dietary intervention study of participants consuming either a healthy low-carbohydrate or a healthy low-fat diet'],[],['weight loss'],"[{'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",49.0,0.0217248,"We used 16S ribosomal RNA gene amplicon sequencing to profile microbiota composition over a 12-mo period in 49 participants as part of a larger randomized dietary intervention study of participants consuming either a healthy low-carbohydrate or a healthy low-fat diet.
","[{'ForeName': 'Gabriela K', 'Initials': 'GK', 'LastName': 'Fragiadakis', 'Affiliation': 'Microbiology and Immunology, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Hannah C', 'Initials': 'HC', 'LastName': 'Wastyk', 'Affiliation': 'Department of Bioengineering, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Robinson', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Sonnenburg', 'Affiliation': 'Microbiology and Immunology, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Sonnenburg', 'Affiliation': 'Microbiology and Immunology, Stanford School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford School of Medicine, Stanford, CA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa046']
43,29254080,Rationale and Design of the Mechanistic Potential of Antihypertensives in Preclinical Alzheimer's (HEART) Trial.,"Research indicates that certain antihypertensive medications alter Alzheimer's disease (AD) biomarkers in Caucasians. The renin angiotensin system (RAS) regulates blood pressure (BP) in the body and the brain and may directly influence AD biomarkers, including amyloid-β (Aβ) neuropathology, cerebral blood flow (CBF), and inflammatory markers. This hypothesis is supported by studies, including ours, showing that antihypertensives targeting the RAS reduce the risk and slow the progression of AD in Caucasians. While mounting evidence supports a protective role of RAS medications in Caucasians, this mechanism has not been explored in African Americans. To assess the mechanism by which RAS medications modify the brain RAS, cerebrospinal fluid (CSF) Aβ, CBF, and inflammatory markers in African Americans, we are conducting an eight month, Phase Ib randomized, placebo controlled trial, enrolling 60 middle-aged (45-70 years), non-demented individuals, at risk for AD by virtue of a parental history. Participants include normotensive and treated hypertensives that have never been exposed to a RAS medication. Participants are randomized (1 : 1:1) by gender and BP medication use (yes/no) to one of three groups: placebo, or 20 mg, or 40 mg telmisartan (Micardis), to determine the dose required to penetrate the CNS. Our overarching hypothesis is that, compared to placebo, both doses of telmisartan will penetrate the CNS and produce salutary, dose dependent effects on the brain RAS as well as CSF Aβ, CBF, and CSF inflammatory markers in African Americans, over eight months. This manuscript describes the trial rationale and design.",2018,"The renin angiotensin system (RAS) regulates blood pressure (BP) in the body and the brain and may directly influence AD biomarkers, including amyloid-β (Aβ) neuropathology, cerebral blood flow (CBF), and inflammatory markers.","['60 middle-aged (45-70 years), non-demented individuals, at risk for AD by virtue of a parental history', 'African Americans', ""Alzheimer's disease (AD) biomarkers in Caucasians"", 'Participants include normotensive and treated hypertensives that have never been exposed to a RAS medication']","['telmisartan', 'placebo', 'placebo, or 20\u200amg, or 40\u200amg telmisartan (Micardis']","['renin angiotensin system (RAS) regulates blood pressure (BP', 'brain RAS, cerebrospinal fluid (CSF', 'amyloid-β (Aβ) neuropathology, cerebral blood flow (CBF), and inflammatory markers']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0042764', 'cui_str': 'Virtues'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0721704', 'cui_str': 'Micardis'}]","[{'cui': 'C0035096'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0007807'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0876934', 'cui_str': 'Neuropathology'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}]",60.0,0.215168,"The renin angiotensin system (RAS) regulates blood pressure (BP) in the body and the brain and may directly influence AD biomarkers, including amyloid-β (Aβ) neuropathology, cerebral blood flow (CBF), and inflammatory markers.","[{'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Wharton', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Felicia C', 'Initials': 'FC', 'LastName': 'Goldstein', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Malú G', 'Initials': 'MG', 'LastName': 'Tansey', 'Affiliation': 'Department of Physiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Brown', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Sonum D', 'Initials': 'SD', 'LastName': 'Tharwani', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Danielle D', 'Initials': 'DD', 'LastName': 'Verble', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Amarallys', 'Initials': 'A', 'LastName': 'Cintron', 'Affiliation': 'Department of Physiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Kehoe', 'Affiliation': 'Dementia Research Group, Faculty of Health Sciences, University of Bristol, Learning and Research, Southmead Hospital, Bristol, UK.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-161198']
44,32033868,The impact of a syndemic theory-based intervention on HIV transmission risk behaviour among men who have sex with men in India: Pretest-posttest non-equivalent comparison group trial.,"This study aimed to examine the effect of a syndemic theory-based intervention to reduce condomless anal intercourse among men who have sex with men (MSM) in India. In 2016/17, a pre- and post-test comparison group design was used to implement a syndemic theory-based intervention among 459 MSM (229, intervention; 230, standard-of-care comparison) recruited through non-governmental organizations in Chandigarh, India. The intervention group received two-session peer-delivered motivational interviewing-based HIV risk reduction counselling and skills training to improve sexual communication/negotiation and condom use self-efficacy, and screening/management of psychosocial health problems. The intervention's effect on consistent condom use was estimated using difference-in-differences (DiD) approach. Mediation analysis assessed the extent to which intervention effects on the outcome were mediated by changes in psychosocial health problems and condom use self-efficacy. A process evaluation assessed implementation fidelity and intervention acceptability. Baseline consistent condom use was 43% in the intervention group and 46% in the standard-of-care group. Baseline survey findings demonstrated that a psychosocial syndemic of problematic alcohol use, internalised homonegativity and violence victimisation synergistically increased condomless anal intercourse. Using DiD, we estimated that the intervention increased consistent condom use with male partners by 16.4% (95% CI: 7.1, 25.7) and with female partners by 28.2% (95% CI: 11.9, 44.4), and decreased problematic alcohol use by 24.3% (95%CI: -33.4, -15.3), depression by 20.0% (95% CI: -27.6, -12.3) and internalised homonegativity by 34.7% (95% CI: -43.6%, -25.8%). The mediation analysis findings suggested that the intervention might have improved consistent condom use by decreasing internalised homonegativity and by increasing condom use self-efficacy. The process evaluation showed high levels of acceptability/satisfaction among participants and high levels of implementation fidelity. A syndemic theory-based intervention tailored for MSM in India is feasible, acceptable, and can reduce HIV transmission risk behaviour as well as problematic alcohol use, depression and internalised homonegativity.",2022,"A syndemic theory-based intervention tailored for MSM in India is feasible, acceptable, and can reduce HIV transmission risk behaviour as well as problematic alcohol use, depression and internalised homonegativity.","['men who have sex with men in India', 'men who have sex with men (MSM) in India']","['syndemic theory-based intervention among 459 MSM (229, intervention; 230, standard-of-care comparison) recruited through non-governmental organizations in Chandigarh, India', 'syndemic theory-based intervention', 'two-session peer-delivered motivational interviewing-based HIV risk reduction counselling and skills training to improve sexual communication/negotiation and condom use self-efficacy, and screening/management of psychosocial health problems']","['HIV transmission risk behaviour', 'internalised homonegativity', 'psychosocial health problems and condom use self-efficacy', 'acceptability/satisfaction', 'problematic alcohol use', 'condomless anal intercourse', 'depression']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C4704689', 'cui_str': 'Syndemic'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0282271', 'cui_str': 'Nongovernmental Organizations'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",459.0,0.0476767,"A syndemic theory-based intervention tailored for MSM in India is feasible, acceptable, and can reduce HIV transmission risk behaviour as well as problematic alcohol use, depression and internalised homonegativity.","[{'ForeName': 'Venkatesan', 'Initials': 'V', 'LastName': 'Chakrapani', 'Affiliation': 'Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India; Centre for Sexuality and Health Research and Policy (C-SHaRP), Chennai, India. Electronic address: venkatesan.chakrapani@gmail.com.'}, {'ForeName': 'Manmeet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Tsai', 'Affiliation': 'Center for Global Health, Massachusetts General Hospital, Boston, USA; Harvard Medical School, Boston, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Newman', 'Affiliation': 'Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.112817']
45,28113118,Social mixing and correlates of injection frequency among opioid use partnerships.,"BACKGROUND


As resources are deployed to address the opioid overdose epidemic in the USA, it is essential that we understand the correlates of more frequent opioid injections-which has been associated not only with HIV and HCV transmission, but also with overdose risk-to inform the development and targeting of effective intervention strategies like overdose prevention and naloxone distribution programs. However, no studies have explored how characteristics of opioid use partnerships may be associated within injection frequency with opioid partnerships.
METHODS


Using baseline data from a trial of a behavioural intervention to reduce overdose among opioid users in San Francisco, CA, we calculated assortativity among opioid use partnerships by race, gender, participant-reported HIV- and HCV-status, and opioids used using Newman's assortativity coefficient (NC). Multivariable generalized estimating equations linear regression was used to examine associations between individual- and partnership-level characteristics and injection frequency within opioid use partnerships.
RESULTS


Opioid use partnerships (n=134) reported by study participants (n=55) were assortative by race (NC=0.42, 95%CI=0.33-0.50) and participant-reported HCV-status (NC=0.42, 95%CI=0.31-0.52). In multivariable analyses, there were more monthly injections among sexual/romantic partnerships (β=114.4, 95%CI=60.2-168.7, p<0.001), racially concordant partnerships reported by white study participants (β=71.4, 95%CI=0.3-142.5, p=0.049), racially discordant partnerships reported by African American study participants (β=105.7, 95%CI=1.0-210.5, p=0.048), and partnerships in which either member had witnessed the other experience an overdose (β=81.8, 95%CI=38.9-124.6, p<0.001).
CONCLUSION


Social segregation by race and HCV-status should potentially be considered in efforts to reach networks of opioid users. Due to higher injection frequency and greater likelihood of witnessing their partners experience an overdose, individuals in sexual/romantic opioid use partnerships, white individuals in racially homogenous partnerships, and African American individuals in heterogeneous partnerships may warrant focused attention as part of peer- and network-based overdose prevention efforts, as well as broader HIV/HCV prevention strategies. Developing and targeting overdose prevention education programs that provide information on risk factors and ways to identify overdose, as well as effective responses, including naloxone use and rescue breathing, for more frequently injecting networks may help reduce opioid morbidity and mortality in these most at risk groups.",2017,"In multivariable analyses, there were more monthly injections among sexual/romantic partnerships (β=114.4, 95%CI=60.2-168.7, p<0.001), racially concordant partnerships reported by white study participants (β=71.4, 95%CI=0.3-142.5, p=0.049), racially discordant partnerships reported by African American study participants (β=105.7, 95%CI=1.0-210.5, p=0.048), and partnerships in which either member had witnessed the other experience an overdose (β=81.8, 95%CI=38.9-124.6, p<0.001).
",[],['behavioural intervention'],"['sexual/romantic partnerships', 'opioid morbidity and mortality']",[],[],"[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",55.0,0.03114,"In multivariable analyses, there were more monthly injections among sexual/romantic partnerships (β=114.4, 95%CI=60.2-168.7, p<0.001), racially concordant partnerships reported by white study participants (β=71.4, 95%CI=0.3-142.5, p=0.049), racially discordant partnerships reported by African American study participants (β=105.7, 95%CI=1.0-210.5, p=0.048), and partnerships in which either member had witnessed the other experience an overdose (β=81.8, 95%CI=38.9-124.6, p<0.001).
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Rowe', 'Affiliation': 'San Francisco Department of Public Health, 25 Van Ness Avenue, Suite 500, San Francisco, CA 94102, USA. Electronic address: chris.rowe@sfdph.org.'}, {'ForeName': 'Glenn-Milo', 'Initials': 'GM', 'LastName': 'Santos', 'Affiliation': 'San Francisco Department of Public Health, 25 Van Ness Avenue, Suite 500, San Francisco, CA 94102, USA; University of California, San Francisco, 500 Parnassus Avenue, San Francisco, CA 94143, USA.'}, {'ForeName': 'Henry F', 'Initials': 'HF', 'LastName': 'Raymond', 'Affiliation': 'San Francisco Department of Public Health, 25 Van Ness Avenue, Suite 500, San Francisco, CA 94102, USA; University of California, San Francisco, 500 Parnassus Avenue, San Francisco, CA 94143, USA.'}, {'ForeName': 'Phillip O', 'Initials': 'PO', 'LastName': 'Coffin', 'Affiliation': 'San Francisco Department of Public Health, 25 Van Ness Avenue, Suite 500, San Francisco, CA 94102, USA; University of California, San Francisco, 500 Parnassus Avenue, San Francisco, CA 94143, USA.'}]",The International journal on drug policy,['10.1016/j.drugpo.2016.11.016']
46,9820260,Treatment of irritable bowel syndrome with Chinese herbal medicine: a randomized controlled trial.,"CONTEXT


Irritable bowel syndrome (IBS) is a common functional bowel disorder for which there is no reliable medical treatment.
OBJECTIVE


To determine whether Chinese herbal medicine (CHM) is of any benefit in the treatment of IBS.
DESIGN


Randomized, double-blind, placebo-controlled trial conducted during 1996 through 1997.
SETTING


Patients were recruited through 2 teaching hospitals and 5 private practices of gastroenterologists, and received CHM in 3 Chinese herbal clinics.
PATIENTS


A total of 116 patients who fulfilled the Rome criteria, an established standard for diagnosis of IBS.
INTERVENTION


Patients were randomly allocated to 1 of 3 treatment groups: individualized Chinese herbal formulations (n = 38), a standard Chinese herbal formulation (n = 43), or placebo (n = 35). Patients received 5 capsules 3 times daily for 16 weeks and were evaluated regularly by a traditional Chinese herbalist and by a gastroenterologist. Patients, gastroenterologists, and herbalists were all blinded to treatment group.
MAIN OUTCOME MEASURES


Change in total bowel symptom scale scores and global improvement assessed by patients and gastroenterologists and change in the degree of interference in life caused by IBS symptoms assessed by patients.
RESULTS


Compared with patients in the placebo group, patients in the active treatment groups (standard and individualized CHM) had significant improvement in bowel symptom scores as rated by patients (P=.03) and by gastroenterologists (P=.001), and significant global improvement as rated by patients (P=.007) and by gastroenterologists (P=.002). Patients reported that treatment significantly reduced the degree of interference with life caused by IBS symptoms (P=.03). Chinese herbal formulations individually tailored to the patient proved no more effective than standard CHM treatment. On follow-up 14 weeks after completion of treatment, only the individualized CHM treatment group maintained improvement.
CONCLUSION


Chinese herbal formulations appear to offer improvement in symptoms for some patients with IBS.",1998,Patients reported that treatment significantly reduced the degree of interference with life caused by IBS symptoms (P=.03).,"['patients with IBS', '1996 through 1997', 'irritable bowel syndrome with Chinese herbal medicine', '116 patients who fulfilled the Rome criteria, an established standard for diagnosis of IBS', 'Patients were recruited through 2 teaching hospitals and 5 private practices of gastroenterologists, and received CHM in 3 Chinese herbal clinics']","['individualized Chinese herbal formulations', 'Chinese herbal medicine (CHM', 'placebo', 'standard Chinese herbal formulation']","['degree of interference with life caused by IBS symptoms', 'total bowel symptom scale scores and global improvement assessed by patients and gastroenterologists and change in the degree of interference in life', 'bowel symptom scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0259901', 'cui_str': 'Gastroenterologist'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0259901', 'cui_str': 'Gastroenterologist'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",116.0,0.5495,Patients reported that treatment significantly reduced the degree of interference with life caused by IBS symptoms (P=.03).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bensoussan', 'Affiliation': 'Research Unit for Complementary Medicine, University of Western Sydney Macarthur, Campbelltown, New South Wales, Australia. a.bensoussan@uws.edu.au'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Talley', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hing', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Menzies', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ngu', 'Affiliation': ''}]",JAMA,[]
47,31287797,"Effect of acupressure on post tonsillectomy pain in adolescents: a randomized, single-blind, placebo-controlled trial study.","INTRODUCTION


Tonsillectomy is one of the most common pediatric surgeries in the world and pain control following tonsillectomy is very important.
OBJECTIVE


The aim of this study is to investigate the effect of acupressure on the amount of pain following tonsillectomy in children.
METHOD


One hundred and forty-four children aged 5-12 years old were assigned into one of three groups: interventions, control and placebo. In the intervention group, acupressure was applied at three acupoints and in the placebo group, sham acupressure was applied. In the control group routine care only was applied.
RESULTS


There was a significant difference between an average of changes in pain score before and after the intervention during the 3 time periods after the tonsillectomy operation in the acupressure group (p = 0.002).
CONCLUSION


The results showed that acupressure had a positive effect on pain reduction after tonsillectomy in children in the intervention group.",2019,There was a significant difference between an average of changes in pain score before and after the intervention during the 3 time periods after the tonsillectomy operation in the acupressure group (p = 0.002).,"['Method One hundred and forty-four children aged 5-12 years old', 'pain following tonsillectomy in children', 'adolescents']","['Introduction Tonsillectomy', 'placebo', 'control and placebo', 'acupressure', 'sham acupressure']","['pain reduction', 'pain score']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",144.0,0.0528416,There was a significant difference between an average of changes in pain score before and after the intervention during the 3 time periods after the tonsillectomy operation in the acupressure group (p = 0.002).,"[{'ForeName': 'Somaye', 'Initials': 'S', 'LastName': 'Pouy', 'Affiliation': 'School of Nursing and Midwifery,Guilan University of Medical Sciences(GUMS), Rasht, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Etebarian Khorasgani', 'Affiliation': 'Student Research Committee, Mazandaran University Of Medical Sciences, sari, iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Azizi-Qadikolaee', 'Affiliation': 'School of Nursing and Midwifery,Guilan University of Medical Sciences(GUMS), Rasht, Iran.'}, {'ForeName': 'Yasaman', 'Initials': 'Y', 'LastName': 'Yaghobi', 'Affiliation': 'School of Nursing and Midwifery,Guilan University of Medical Sciences(GUMS), Rasht, Iran.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2019-0065']
48,30851351,HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): A Randomized Controlled Trial of Hyperbaric Oxygen to Prevent Osteoradionecrosis of the Irradiated Mandible After Dentoalveolar Surgery.,"PURPOSE


Hyperbaric oxygen (HBO) has been advocated in the prevention and treatment of osteoradionecrosis (ORN) of the jaw after head and neck radiation therapy, but supporting evidence is weak. The aim of this randomized trial was to establish the benefit of HBO in the prevention of ORN after high-risk surgical procedures to the irradiated mandible.
METHODS AND MATERIALS


HOPON was a randomized, controlled, phase 3 trial. Participants who required dental extractions or implant placement in the mandible with prior radiation therapy >50 Gy were recruited. Eligible patients were randomly assigned 1:1 to receive or not receive HBO. All patients received chlorhexidine mouthwash and antibiotics. For patients in the HBO arm, oxygen was administered in 30 daily dives at 100% oxygen to a pressure of 2.4 atmospheres absolute for 80 to 90 minutes. The primary outcome measure was the diagnosis of ORN 6 months after surgery, as determined by a blinded central review of clinical photographs and radiographs. The secondary endpoints included grade of ORN, ORN at other time points, acute symptoms, pain, and quality of life.
RESULTS


A total of 144 patients were randomized, and data from 100 patients were analyzed for the primary endpoint. The incidence of ORN at 6 months was 6.4% and 5.7% for the HBO and control groups, respectively (odds ratio, 1.13; 95% confidence interval, 0.14-8.92; P = 1). Patients in the hyperbaric arm had fewer acute symptoms but no significant differences in late pain or quality of life. Dropout was higher in the HBO arm, but the baseline characteristics of the groups that completed the trial were comparable between the 2 arms.
CONCLUSIONS


The low incidence of ORN makes recommending HBO for dental extractions or implant placement in the irradiated mandible unnecessary. These findings are in contrast with a recently published Cochrane review and previous trials reporting rates of ORN (non-HBO) of 14% to 30% and challenge a long-established standard of care.",2019,"The incidence of ORN at 6 months was 6.4% and 5.7% for the HBO and control groups, respectively (odds ratio, 1.13;","['Participants who required dental extractions or implant placement in the mandible with prior radiation therapy', '144 patients were randomized, and data from 100 patients were analyzed for the primary endpoint', '50\xa0Gy were recruited', 'Eligible patients', 'Osteoradionecrosis']","['HOPON (Hyperbaric Oxygen', 'Hyperbaric oxygen (HBO', 'HBO', 'Hyperbaric Oxygen', 'chlorhexidine mouthwash and antibiotics']","['incidence of ORN', 'diagnosis of ORN 6\xa0months after surgery, as determined by a blinded central review of clinical photographs and radiographs', 'late pain or quality of life', 'grade of ORN, ORN at other time points, acute symptoms, pain, and quality of life', 'acute symptoms']","[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0024687', 'cui_str': 'Mandible'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0029461', 'cui_str': 'Osteoradionecrosis'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3666901', 'cui_str': 'Chlorhexidine Mouthwash [Paroex]'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",144.0,0.307039,"The incidence of ORN at 6 months was 6.4% and 5.7% for the HBO and control groups, respectively (odds ratio, 1.13;","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Shaw', 'Affiliation': 'University of Liverpool, Liverpool, United Kingdom. Electronic address: rjshaw@liv.ac.uk.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Butterworth', 'Affiliation': 'Maxillofacial Prosthodontics, Department of Maxillofacial Surgery, University Hospital Aintree, Liverpool, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Silcocks', 'Affiliation': 'Cancer Research UK Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Binyam T', 'Initials': 'BT', 'LastName': 'Tesfaye', 'Affiliation': 'Cancer Research UK Liverpool Cancer Trials Unit, Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bickerstaff', 'Affiliation': 'Cancer Research UK Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jackson', 'Affiliation': 'Cancer Research UK Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Anastios', 'Initials': 'A', 'LastName': 'Kanatas', 'Affiliation': 'OMFS Department, Leeds Dental Institute, Leeds, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nixon', 'Affiliation': 'Restorative Department, Leeds Dental Institute, Leeds, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McCaul', 'Affiliation': 'Regional Maxillofacial Unit, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Prav', 'Initials': 'P', 'LastName': 'Praveen', 'Affiliation': 'Maxillofacial Office, Queen Elizabeth Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Lowe', 'Affiliation': 'Aberdeen Royal Infirmary, Aberdeen, Scotland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Blanco-Guzman', 'Affiliation': 'Maxillofacial Unit, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, Taunton, United Kingdom.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Forner', 'Affiliation': 'Departments of Anesthesia and Oral and Maxillofacial Surgery, Centre of Head and Orthopedics, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brennan', 'Affiliation': 'Maxillofacial Unit, Queen Alexandra Hospital, Portsmouth, United Kingdom.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Fardy', 'Affiliation': 'University Hospital of Wales, Cardiff, Wales, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Parkin', 'Affiliation': 'OMFS Department, ABUHB, Newport, Wales, United Kingdom.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Smerdon', 'Affiliation': 'DDRC Healthcare, Hyperbaric Medical Centre, Plymouth, United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Stephenson', 'Affiliation': 'NHS Grampian, Aberdeen Royal Infirmary, Aberdeen, Scotland.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Cope', 'Affiliation': 'North West Recompression Unit, Murrayfield Hospital, Holmwood, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Glover', 'Affiliation': ""Hyperbaric Medicine Unit, St. Richard's Hospital, Chichester, United Kingdom.""}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2019.02.044']
49,31771375,Influence of social support on asthma self-management in adolescents.,"OBJECTIVE


Adolescents with asthma are influenced by peers and family. The objective was to better understand family social support and test its association with medication adherence, asthma control, and Emergency Department (ED) use.
METHODS


This study is a cross-sectional secondary data analysis from a randomized controlled trial with urban adolescents from three U.S. cities. Participants (12-20 years old) with asthma completed the Perceived Family Support Scale (PFS) and Horne's Medication Adherence Report Scale (MARS). Data from both tools were classified into 2 categories- high and low (< 25 th  percentile) perceived family support and high (total score >10) and low medication adherence, respectively. Chi-square statistic and logistic regression were used for analysis.
RESULTS


Of the 371 participants, the majority were young (96% ≤ 17 years), African American or Bi-racial (85%), and Medicaid-insured (72%); over one-third had maternal family history of asthma. Among those on a controller medication ( n  = 270), only 37% reported its use ≥8 days over 2 weeks. Asthma control was poor with 50% categorized ""not well controlled,"" 34% ""very poorly controlled."" Participants responded positively to most social support items. One item, providing and receiving social support to and from family members, was less often positively reported. Low medication adherence was significantly associated with lower perceived social support ( p  = 0.018).
CONCLUSION


This study underscores the importance of family social support in understanding the extent of adolescents' self-management, particularly medication adherence.",2021,Low medication adherence was significantly associated with lower perceived social support (p = 0.018).  ,"['371 participants', 'adolescents', 'urban adolescents from three U.S. cities', 'majority were young (96% ≤ 17 years), African American or Bi-racial (85%), and Medicaid-insured (72%); over one-third had maternal family history of asthma', 'Participants (12-20 years old) with asthma completed the']",['family social support'],"['Low medication adherence', ""Perceived Family Support Scale (PFS) and Horne's Medication Adherence Report Scale (MARS""]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1261327', 'cui_str': 'Family history of asthma'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037438'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0150232', 'cui_str': 'Family support (regime/therapy)'}, {'cui': 'C0222045'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",371.0,0.0221786,Low medication adherence was significantly associated with lower perceived social support (p = 0.018).  ,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sloand', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Butz', 'Affiliation': 'Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Hyekyun', 'Initials': 'H', 'LastName': 'Rhee', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Walters', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Breuninger', 'Affiliation': 'Primary Care Pediatric Nurse Practitioner, Park Pediatrics, Takoma Park, MD, USA.'}, {'ForeName': 'Rosario Alejandra', 'Initials': 'RA', 'LastName': 'Pozzo', 'Affiliation': 'Pediatric Nurse Practitioner, East Pompano Pediatrics, Pompano Beach, FL, USA.'}, {'ForeName': 'Christina Marie', 'Initials': 'CM', 'LastName': 'Barnes', 'Affiliation': ""Pediatric Nurse Practitioner, Center for Colorectal and Pelvic Reconstruction, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Mona Newsome', 'Initials': 'MN', 'LastName': 'Wicks', 'Affiliation': 'Health Promotion and Disease Prevention Department, University of Tennessee Health Science Center, College of Nursing, Memphis, TN, USA.'}, {'ForeName': 'Laurene', 'Initials': 'L', 'LastName': 'Tumiel-Berhalter', 'Affiliation': 'Department of Family Medicine, Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, Buffalo, NY, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2019.1698601']
50,31195244,Safety and efficacy of first-line smoking cessation pharmacotherapies in bipolar disorders: Subgroup analysis of a randomized clinical trial.,"OBJECTIVES


Post hoc analyses of EAGLES data to examine safety and efficacy of first-line smoking cessation pharmacotherapies in smokers with bipolar disorders (BD).
METHODS


Smokers with BD I/II (n = 285; 81.4% with BD I) and a comparison nonpsychiatric cohort (NPC; n = 2794) were randomly assigned to varenicline, bupropion, nicotine replacement therapy (NRT), or placebo for 12 weeks, plus weekly counseling. Primary outcomes were occurrence of moderate to severe neuropsychiatric adverse events (NPSAEs) and Weeks 9-12 biochemically-confirmed continuous abstinence (CA) rates.
RESULTS


For BD smokers, NPSAE risk differences versus placebo were: varenicline, 6.17 (95% CI: -7.84 to 20.18); bupropion, 4.09 (-8.82 to 16.99); NRT, -0.56 (-12.34 to 11.22). ORs for Weeks 9-12 CA, comparing active medication to placebo among BD smokers were: varenicline, 2.61 (0.68-9.95); bupropion, 1.29 (0.31-5.37), NRT, 0.71 (0.14-3.74). Pooling across treatments, NPSAE occurrence was higher (10.7% versus 2.3%; P < 0.001) and CA rates were lower (22.8% versus 13.3%; P = 0.008) in BD than NPC.
LIMITATIONS


Study not powered to detect differences in safety and efficacy in the BD subcohort; generalizability limited to stably treated BD without current substance use disorders.
CONCLUSIONS


Smokers with BD had higher risk of NPSAEs and were less likely to quit overall than NPC smokers. Among smokers with BD, NPSAE risk difference estimates for active treatments versus placebo ranged from 1% lower to 6% higher. Efficacy of varenicline in smokers with BD was similar to EAGLES main outcomes; bupropion and NRT effect sizes were descriptively lower. Varenicline may be a tolerable and effective cessation treatment for smokers with BD.
TRIAL REGISTRATION


ClinicalTrials.gov identifier (https://clinicaltrials.gov/): NCT01456936.",2019,"Pooling across treatments, NPSAE occurrence was higher (10.7% versus 2.3%; P < 0.001) and CA rates were lower (22.8% versus 13.3%; P = 0.008) in BD than NPC.
","['Smokers with BD I/II (n\u202f=\u202f285', 'bipolar disorders', 'smokers with BD', 'For BD smokers', 'smokers with bipolar disorders (BD']","['Varenicline', 'bupropion', 'placebo', 'varenicline', 'first-line smoking cessation pharmacotherapies', 'varenicline, bupropion, nicotine replacement therapy (NRT), or placebo']","['Efficacy', 'safety and efficacy', 'NPSAE occurrence', 'CA rates', 'occurrence of moderate to severe neuropsychiatric adverse events (NPSAEs) and Weeks 9-12 biochemically-confirmed continuous abstinence (CA) rates', 'Safety and efficacy']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0013216', 'cui_str': 'Pharmacotherapy'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]",2794.0,0.13284,"Pooling across treatments, NPSAE occurrence was higher (10.7% versus 2.3%; P < 0.001) and CA rates were lower (22.8% versus 13.3%; P = 0.008) in BD than NPC.
","[{'ForeName': 'Jaimee L', 'Initials': 'JL', 'LastName': 'Heffner', 'Affiliation': 'Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, M3-B232; PO Box 19024; Seattle, WA 98109, USA. Electronic address: jheffner@fredhutch.org.'}, {'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Russ', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lawrence', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Ayers', 'Affiliation': 'University of California, San Diego, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McRae', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Lisa St', 'Initials': 'LS', 'LastName': 'Aubin', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Krishen', 'Affiliation': 'PAREXEL International on behalf of GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'University College, London, UK.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Anthenelli', 'Affiliation': 'University of California, San Diego, CA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2019.06.008']
51,31791141,Religious coping and acceptability and outcome of short-term psychotherapeutic treatments for depression among low-income homebound older adults.,"OBJECTIVES


To examine (1) correlates of religious coping, and (2) associations of religious coping at baseline with evaluation of treatment acceptability and depressive symptom severity outcomes of short-term psychotherapeutic depression treatments among 277 low-income homebound older adults (70% female; 41% non-Hispanic White, 30% African American, and 29% Hispanic) who participated in a treatment effectiveness trial.
METHOD


Religious coping was measured with a 2-item subscale of the Brief COPE. Treatment acceptability was measured with the 11-item Treatment Evaluation Inventory (TEI). Depressive symptoms were measured with the 24-item Hamilton Rating Scale for Depression (HAMD). We used linear regression modeling to examine correlates of religious coping at baseline and to examine associations of religious coping with treatment acceptability and depression outcome at 12 weeks.
RESULTS


Being female and being African American predicted higher religious coping. Additionally, active coping, emotional support coping, and clergy consultation on depression were significantly associated with higher religious coping. Religious coping was not significantly associated with TEI and HAMD scores at 12 weeks.
CONCLUSION


The findings show that once these older adults participate in depression treatment, they find it highly acceptable and benefit from treatment, regardless of their religious coping, and that psychotherapeutic treatment is a highly acceptable and effective addition to those with religious-oriented coping.",2021,"Additionally, active coping, emotional support coping, and clergy consultation on depression were significantly associated with higher religious coping.","['depression among low-income homebound older adults', '277 low-income homebound older adults (70% female; 41% non-Hispanic White, 30% African American, and 29% Hispanic) who participated in a treatment effectiveness trial']","['short-term psychotherapeutic treatments', 'short-term psychotherapeutic depression treatments']","['TEI and HAMD scores', 'Depressive symptoms', '24-item Hamilton Rating Scale for Depression (HAMD', 'active coping, emotional support coping, and clergy consultation on depression', 'religious coping', 'Treatment acceptability']","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0242798', 'cui_str': 'Home-Bound Persons'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0600015', 'cui_str': 'Emotional support (regime/therapy)'}, {'cui': 'C0008935', 'cui_str': 'Clergy'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",277.0,0.0367208,"Additionally, active coping, emotional support coping, and clergy consultation on depression were significantly associated with higher religious coping.","[{'ForeName': 'Namkee G', 'Initials': 'NG', 'LastName': 'Choi', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas, Austin, TX, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Sullivan', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas, Austin, TX, USA.'}, {'ForeName': 'C Nathan', 'Initials': 'CN', 'LastName': 'Marti', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas, Austin, TX, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Kunik', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. Debakey VA Medical Center, Houston, TX, USA.'}]",Aging & mental health,['10.1080/13607863.2019.1697204']
52,31188778,The effect of acceptance and commitment therapy on the mental health of students with an emotional breakdown.,"BACKGROUND


Mental health is a significant part of one's health and it is very important to pay attention to mental health.
OBJECTIVES


The aim of the study was to examine the effect of acceptance and commitment therapy (ACT) on the mental health of adolescents with an emotional breakdown (EB).
METHODS


This was a semi-experimental study, in which the students with an EB were divided into two groups: the experimental and control groups. Twenty people were selected using the convenience sampling method and randomly assigned to the ACT and control groups (each with 10 people). After obtaining consent to participate in the study, they were asked to fill the questionnaires as a pre-test. Then, the experimental group was treated for nine individual sessions (weekly one session). As this was a repeated measurement method, in sessions 3, 6 and 9, the questionnaires were completed again and the follow-up period was 1 month after the end of the interventions.
RESULTS


Before the intervention, there was no difference between the score of the impact of love and rumination among the students in the experimental and control groups (p > 0.05); but after the intervention, the score of the impact of love and rumination in the experimental group decreased (p < 0.05).
CONCLUSIONS


It is suggested that ACT should be used at counseling centers of universities and educational institutions.",2019,", there was no difference between the score of the impact of love and rumination among the students in the experimental and control groups (p > 0.05); but after the intervention, the score of the impact of love and rumination in the experimental group decreased (p < 0.05).","['students with an EB', 'adolescents with an emotional breakdown (EB', 'mental health of students with an emotional breakdown', 'Twenty people were selected using the convenience sampling method and randomly assigned to the ACT and control groups (each with 10 people']","['acceptance and commitment therapy (ACT', 'acceptance and commitment therapy']","['love and rumination', 'score of the impact of love and rumination']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}]","[{'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",20.0,0.0307614,", there was no difference between the score of the impact of love and rumination among the students in the experimental and control groups (p > 0.05); but after the intervention, the score of the impact of love and rumination in the experimental group decreased (p < 0.05).","[{'ForeName': 'Seyedeh Maryam', 'Initials': 'SM', 'LastName': 'Noormohamadi', 'Affiliation': 'Department of Psychology and Counseling, Kermanshah Branch, Islamic Azad University, Kermanshah, Iran.'}, {'ForeName': 'Mokhtar', 'Initials': 'M', 'LastName': 'Arefi', 'Affiliation': 'Department of Psychology and Counseling, Kermanshah Branch, Islamic Azad University, Kermanshah, Iran, Phone: +98-9183308112.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Afshaini', 'Affiliation': 'Department of Psychology and Counseling, Kermanshah Branch, Islamic Azad University, Kermanshah, Iran.'}, {'ForeName': 'Keivan', 'Initials': 'K', 'LastName': 'Kakabaraee', 'Affiliation': 'Department of Psychology and Counseling, Kermanshah Branch, Islamic Azad University, Kermanshah, Iran.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2019-0096']
53,31188779,The effect of rational-emotive behavior therapy on anxiety and resilience in students.,"BACKGROUND


Adolescence and youth are important periods in the growth and excellence of an individual.
OBJECTIVES


Given the importance of the study, its purpose was to determine the effect of rational-emotive behavior therapy (REBT) on anxiety and resilience in students.
METHODS


Students admitted to the counseling centers of Ilam University were randomly assigned to experimental and control groups. Using convenient sampling method, 30 subjects were selected and randomly assigned to either REBT tests or a control group (10 subjects in each). The 26 codes of ethics were observed in the study and the data were analyzed using SPSS17.
RESULTS


Before the intervention, the anxiety score was 26.75 (4.43) and after the intervention it was 18 (4.403) (p < 0.05), but in the control group it was 31.34 (6.04) before the intervention and after the intervention it was 32.35 (5.17) (p > 0.05). Before the intervention, the anxiety score was 52.77 (13.37) and after the intervention it was 60.00 (14.31) (p < 0.05), but in the control group it was 47.00 (8.73) before the intervention and after the intervention it was 49.76 (9.10) (p > 0.05).
CONCLUSIONS


REBT was effective in students as it reduced anxiety and increased resilience. Thus, it is suggested for use in students' care.",2019,"Before the intervention, the anxiety score was 52.77 (13.37) and after the intervention it was 60.00 (14.31) (p < 0.05), but in the control group it was 47.00 (8.73) before the intervention and after the intervention it was 49.76 (9.10) (p > 0.05).","['30 subjects', 'Methods Students admitted to the counseling centers of Ilam University', 'students']","['rational-emotive behavior therapy (REBT', 'rational-emotive behavior therapy']","['anxiety score', 'anxiety and resilience']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",30.0,0.0234962,"Before the intervention, the anxiety score was 52.77 (13.37) and after the intervention it was 60.00 (14.31) (p < 0.05), but in the control group it was 47.00 (8.73) before the intervention and after the intervention it was 49.76 (9.10) (p > 0.05).","[{'ForeName': 'Seyedeh Maryam', 'Initials': 'SM', 'LastName': 'Noormohamadi', 'Affiliation': 'Department of Counseling and Psychology, Kermanshah Branch, Islamic Azad University, Kermanshah, Iran.'}, {'ForeName': 'Mokhtar', 'Initials': 'M', 'LastName': 'Arefi', 'Affiliation': 'Department of Counseling and Psychology, Kermanshah Branch, Islamic Azad University, Kermanshah, Iran, Phone: +98-9183308112.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Afshaini', 'Affiliation': 'Department of Counseling and Psychology, Kermanshah Branch, Islamic Azad University, Kermanshah, Iran.'}, {'ForeName': 'Keivan', 'Initials': 'K', 'LastName': 'Kakabaraee', 'Affiliation': 'Department of Counseling and Psychology, Kermanshah Branch, Islamic Azad University, Kermanshah, Iran.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2019-0099']
54,31165641,The Clinical Utility of Maceration Dressings in the Treatment of Inpatient Hand Infections: An Evaluation of Treatment Outcomes Compared to Standard Care.,"Background:  In cases of oral antibiotic-resistant infection of the hand, we propose utilizing a heated, moist maceration dressing to help shorten and simplify the in-hospital clinical course by increasing the efficacy of antibiotic deliverance to infection sites, increasing the success of nonoperative management, and decreasing eradication time of infection of the hand.  Methods:  Fifty-six patients older than 18 years of age who presented with hand infections requiring inpatient intravenous antibiotics at our suburban academic hospital over a 30-month period were included and randomly assigned to either the maceration dressing group or the standard treatment group. Maceration dressings included warm and moist gauze, kerlix, webril, Orthoglass, Aqua K Pad, and sling.  Results:  Fifty-two patients who were mostly male and younger than 60 years of age were included. Patients who used the maceration dressing had significantly shorter hospital lengths of stay ( P  = .02) and intravenous antibiotics duration before transition to oral antibiotics ( P  = .04), and decreased need for formal operating room irrigation and debridement to obtain source control ( P  = .02) compared to patients treated with the standard dressing. Post-hoc analysis yielded improved outcomes when using the maceration dressing regardless of whether initial bedside incision and drainage was needed to decompress a superficial abscess or not.  Conclusion:  The maceration dressing can be used along with proper intravenous antibiotic treatment to improve the treatment course of patients with hand infections regardless of whether the patient needs an initial bedside incision and drainage or not.  Level of Evidence:  Therapeutic Level II.",2021,"Patients who used the maceration dressing had significantly shorter hospital lengths of stay ( P = .02) and intravenous antibiotics duration before transition to oral antibiotics ( P = .04), and decreased need for formal operating room irrigation and debridement to obtain source control ( P = .02) compared to patients treated with the standard dressing.","['Fifty-six patients older than 18 years of age who presented with hand infections requiring inpatient intravenous antibiotics at our suburban academic hospital over a 30-month period', 'Inpatient Hand Infections', 'Fifty-two patients who were mostly male and younger than 60 years of age were included']","['maceration dressing group or the standard treatment group', 'Maceration Dressings']","['shorter hospital lengths of stay', 'warm and moist gauze, kerlix, webril, Orthoglass, Aqua K Pad, and sling', 'intravenous antibiotics duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0333525', 'cui_str': 'Maceration (morphologic abnormality)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C0590323', 'cui_str': 'Gauzes (physical object)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0441637', 'cui_str': 'Slinging'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",56.0,0.0313785,"Patients who used the maceration dressing had significantly shorter hospital lengths of stay ( P = .02) and intravenous antibiotics duration before transition to oral antibiotics ( P = .04), and decreased need for formal operating room irrigation and debridement to obtain source control ( P = .02) compared to patients treated with the standard dressing.","[{'ForeName': 'Ajith', 'Initials': 'A', 'LastName': 'Malige', 'Affiliation': ""St. Luke's University Health Network, Bethlehem, PA, USA.""}, {'ForeName': 'Vince', 'Initials': 'V', 'LastName': 'Lands', 'Affiliation': ""St. Luke's University Health Network, Bethlehem, PA, USA.""}, {'ForeName': 'Kristofer S', 'Initials': 'KS', 'LastName': 'Matullo', 'Affiliation': ""St. Luke's University Health Network, Bethlehem, PA, USA.""}]","Hand (New York, N.Y.)",['10.1177/1558944719852744']
55,17921398,Serum zinc and pneumonia in nursing home elderly.,"BACKGROUND


Zinc plays an important role in immune function. The association between serum zinc and pneumonia in the elderly has not been studied.
OBJECTIVE


The objective was to determine whether serum zinc concentrations in nursing home elderly are associated with the incidence and duration of pneumonia, total and duration of antibiotic use, and pneumonia-associated and all-cause mortality.
DESIGN


This observational study was conducted in residents from 33 nursing homes in Boston, MA, who participated in a 1-y randomized, double-blind, and placebo-controlled vitamin E supplementation trial; all were given daily doses of 50% of the recommended dietary allowance of essential vitamins and minerals, including zinc. Participants with baseline (n = 578) or final (n = 420) serum zinc concentrations were categorized as having low (<70 microg/dL) or normal (>or=70 microg/dL) serum zinc concentrations. Outcome measures included the incidence and number of days with pneumonia, number of new antibiotic prescriptions, days of antibiotic use, death due to pneumonia, and all-cause mortality.
RESULTS


Compared with subjects with low zinc concentrations, subjects with normal final serum zinc concentrations had a lower incidence of pneumonia, fewer (by almost 50%) new antibiotic prescriptions, a shorter duration of pneumonia, and fewer days of antibiotic use (3.9 d compared with 2.6 d) (P <or= 0.004 for all). Normal baseline serum zinc concentrations were associated with a reduction in all-cause mortality (P = 0.049).
CONCLUSION


Normal serum zinc concentrations in nursing home elderly are associated with a decreased incidence and duration of pneumonia, a decreased number of new antibiotic prescriptions, and a decrease in the days of antibiotic use. Zinc supplementation to maintain normal serum zinc concentrations in the elderly may help reduce the incidence of pneumonia and associated morbidity.",2007,"Normal baseline serum zinc concentrations were associated with a reduction in all-cause mortality (P = 0.049).
","['nursing home elderly', 'Participants with baseline (n = 578) or final (n = 420) serum zinc concentrations were categorized as having low (<70 microg/dL) or normal (>or=70 microg/dL) serum zinc concentrations', 'residents from 33 nursing homes in Boston, MA, who participated']","['Zinc supplementation', 'dietary allowance of essential vitamins and minerals, including zinc', 'placebo-controlled vitamin E']","['Serum zinc and pneumonia', 'serum zinc concentrations', 'Normal baseline serum zinc concentrations', 'shorter duration of pneumonia, and fewer days of antibiotic use', 'incidence and number of days with pneumonia, number of new antibiotic prescriptions, days of antibiotic use, death due to pneumonia, and all-cause mortality']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0856205', 'cui_str': 'Serum zinc'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0006037', 'cui_str': 'Boston'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0205224', 'cui_str': 'Essential (qualifier value)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}]","[{'cui': 'C0856205', 'cui_str': 'Serum zinc'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.187893,"Normal baseline serum zinc concentrations were associated with a reduction in all-cause mortality (P = 0.049).
","[{'ForeName': 'Simin N', 'Initials': 'SN', 'LastName': 'Meydani', 'Affiliation': 'Nutritional Immunology Laboratory, Jean Mayer US Department of Agriculture Human Nutrition Research Center on Aging at Tufts University, Boston, MA 02111, USA. simin.meydani@tufts.edu'}, {'ForeName': 'Junaidah B', 'Initials': 'JB', 'LastName': 'Barnett', 'Affiliation': ''}, {'ForeName': 'Gerard E', 'Initials': 'GE', 'LastName': 'Dallal', 'Affiliation': ''}, {'ForeName': 'Basil C', 'Initials': 'BC', 'LastName': 'Fine', 'Affiliation': ''}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Jacques', 'Affiliation': ''}, {'ForeName': 'Lynette S', 'Initials': 'LS', 'LastName': 'Leka', 'Affiliation': ''}, {'ForeName': 'Davidson H', 'Initials': 'DH', 'LastName': 'Hamer', 'Affiliation': ''}]",The American journal of clinical nutrition,[]
56,28969313,Randomized trial of near-infrared spectroscopy for personalized optimization of cerebral tissue oxygenation during cardiac surgery.,"Background


We assessed whether a near-infrared spectroscopy (NIRS)-based algorithm for the personalized optimization of cerebral oxygenation during cardiopulmonary bypass combined with a restrictive red cell transfusion threshold would reduce perioperative injury to the brain, heart, and kidneys.
Methods


In a randomized controlled trial, participants in three UK centres were randomized with concealed allocation to a NIRS (INVOS 5100; Medtronic Inc., Minneapolis, MN, USA)-based 'patient-specific' algorithm that included a restrictive red cell transfusion threshold (haematocrit 18%) or to a 'generic' non-NIRS-based algorithm (standard care). The NIRS algorithm aimed to maintain cerebral oxygenation at an absolute value of > 50% or at > 70% of baseline values. The primary outcome for the trial was cognitive function measured up to 3 months postsurgery.
Results


The analysis population comprised eligible randomized patients who underwent valve or combined valve surgery and coronary artery bypass grafts using cardiopulmonary bypass between December 2009 and January 2014 ( n =98 patient-specific algorithm; n =106 generic algorithm). There was no difference between the groups for the three core cognitive domains (attention, verbal memory, and motor coordination) or for the non-core domains psychomotor speed and visuo-spatial skills. The NIRS group had higher scores for verbal fluency; mean difference 3.73 (95% confidence interval 1.50, 5.96). Red cell transfusions, biomarkers of brain, kidney, and myocardial injury, adverse events, and health-care costs were similar between the groups.
Conclusions


These results do not support the use of NIRS-based algorithms for the personalized optimization of cerebral oxygenation in adult cardiac surgery.
Clinical trial registration


http://www.controlled-trials.com , ISRCTN 23557269.",2017,"There was no difference between the groups for the three core cognitive domains (attention, verbal memory, and motor coordination) or for the non-core domains psychomotor speed and visuo-spatial skills.","['participants in three UK centres', 'cardiac surgery', 'between December 2009 and January 2014 ( n =98 patient-specific algorithm; n =106 generic algorithm']","['valve or combined valve surgery and coronary artery bypass grafts using cardiopulmonary bypass', 'NIRS (INVOS 5100; Medtronic Inc., Minneapolis, MN', 'near-infrared spectroscopy (NIRS)-based algorithm', 'near-infrared spectroscopy']","['cognitive function measured up to 3\u2009months postsurgery', 'verbal fluency', 'Red cell transfusions, biomarkers of brain, kidney, and myocardial injury, adverse events, and health-care costs', 'cerebral tissue oxygenation', 'cognitive domains (attention, verbal memory, and motor coordination) or for the non-core domains psychomotor speed and visuo-spatial skills']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0002045'}]","[{'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0376519', 'cui_str': 'Spectrometry, Near-Infrared'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002045'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}]",106.0,0.244682,"There was no difference between the groups for the three core cognitive domains (attention, verbal memory, and motor coordination) or for the non-core domains psychomotor speed and visuo-spatial skills.","[{'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Bristol BS2?8HW, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stoica', 'Affiliation': 'Bristol Heart Institute and National Institute for Health Research Bristol Biomedical Research Unit in Cardiovascular Medicine, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Bristol BS2?8HW, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ellis', 'Affiliation': 'Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Bristol BS2?8HW, UK.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Stokes', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Old Road, Headington, Oxford OX3?7LF, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wordsworth', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Old Road, Headington, Oxford OX3?7LF, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dabner', 'Affiliation': 'Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Bristol BS2?8HW, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Clayton', 'Affiliation': 'Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Bristol BS2?8HW, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Downes', 'Affiliation': 'Bristol Heart Institute and National Institute for Health Research Bristol Biomedical Research Unit in Cardiovascular Medicine, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Bristol BS2?8HW, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nicholson', 'Affiliation': 'Bristol Heart Institute and National Institute for Health Research Bristol Biomedical Research Unit in Cardiovascular Medicine, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Bristol BS2?8HW, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bennett', 'Affiliation': 'Cardiac Anaesthesia and Intensive Care, King Faisal Cardiac Center, NGHA, Jeddah, Saudi Arabia.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Angelini', 'Affiliation': 'Bristol Heart Institute and National Institute for Health Research Bristol Biomedical Research Unit in Cardiovascular Medicine, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Bristol BS2?8HW, UK.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Bristol BS2?8HW, UK.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Murphy', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester LE3?9QP, UK.'}]",British journal of anaesthesia,['10.1093/bja/aex182']
57,30021811,Expression network analysis reveals cord blood vitamin D-associated genes affecting risk of early life wheeze.,"Cord blood 25-hydroxyvitamin D (25OHD) has been reported in association with risk of early life recurrent wheeze. In a subset of infants who participated in the Vitamin D Antenatal Asthma Reduction Trial, we demonstrated that higher cord blood 25OHD at birth (>31 ng/mL) was associated with a reduced risk of recurrent wheeze in the first year of life. We then identified a module of co-expressed genes associated with cord blood 25OHD levels >31 ng/mL. Genes in this module are involved in biological and immune pathways related to development and progression of asthma pathogenesis including the Notch1 and transforming growth factor-beta signalling pathways.",2019,We then identified a module of co-expressed genes associated with cord blood 25OHD levels >31 ng/mL. Genes in this module are involved in biological and immune pathways related to development and progression of asthma pathogenesis including the Notch1 and transforming growth factor-beta signalling pathways.,[],[],"['higher cord blood 25OHD at birth', 'Cord blood 25-hydroxyvitamin D (25OHD']",[],[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",,0.166191,We then identified a module of co-expressed genes associated with cord blood 25OHD levels >31 ng/mL. Genes in this module are involved in biological and immune pathways related to development and progression of asthma pathogenesis including the Notch1 and transforming growth factor-beta signalling pathways.,"[{'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Mirzakhani', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Amal A', 'Initials': 'AA', 'LastName': 'Al-Garawi', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Carey', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Weiliang', 'Initials': 'W', 'LastName': 'Qiu', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Augusto A', 'Initials': 'AA', 'LastName': 'Litonjua', 'Affiliation': ""Division of Pediatric Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, New York, USA.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}]",Thorax,['10.1136/thoraxjnl-2018-211962']
58,30466334,Age Moderates the Effect of Self-Paced Exercise on Exercise Adherence among Overweight Adults.,"Objective:  The present study tested the hypothesis that the effect of self-paced exercise on adherence to exercise programs is more pronounced with increasing age.  Method:  Fifty-nine low-active overweight adults (18-65 years) were encouraged to walk 30 to 60 min/day and randomized to either self-paced ( n  = 30) or prescribed moderate-intensity ( n  = 29) conditions.  Results:  The effect of study condition was moderated by age (main effect:  b  = 6.14,  SE  = 2.54,  p  = .02; Condition × Age:  b  = -11.55,  SE  = 3.77,  p  < .01), such that among participants >50 years, those in the self-paced condition exercised 6 more min/day than participants in the prescribed moderate-intensity condition ( p  = .02), whereas among participants <50 years, those in the self-paced condition exercised 5.4 fewer min/day compared with those in the moderate-intensity condition ( p  = .05). Affective response to physical activity did not mediate the moderating effect of age.  Discussion:  As age increases, adults may be more likely to adhere to self-paced versus prescribed moderate-intensity exercise.",2020,"The effect of study condition was moderated by age (main effect: b = 6.14, SE = 2.54, p = .02; Condition × Age: b = -11.55, SE = 3.77, p < .01), such that","['Overweight Adults', 'Fifty-nine low-active overweight adults (18-65 years']","['Self-Paced Exercise', 'self-paced exercise']",['Exercise Adherence'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0248716,"The effect of study condition was moderated by age (main effect: b = 6.14, SE = 2.54, p = .02; Condition × Age: b = -11.55, SE = 3.77, p < .01), such that","[{'ForeName': 'Harold H', 'Initials': 'HH', 'LastName': 'Lee', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Dunsiger', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Connell Bohlen', 'Affiliation': 'The University of Rhode Island, Kingston, USA.'}, {'ForeName': 'Holly K', 'Initials': 'HK', 'LastName': 'Boyle', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Emerson', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Williams', 'Affiliation': 'Brown University, Providence, RI, USA.'}]",Journal of aging and health,['10.1177/0898264318812139']
59,30612854,"A randomized, double-blind, placebo-controlled trial of lamotrigine for prescription corticosteroid effects on the human hippocampus.","In animals, stress and corticosteroid excess are associated with decreases in memory performance and hippocampal volume that may be prevented with agents that decrease glutamate release. Humans also demonstrate changes in memory and hippocampus with corticosteroids. In this report the effects of glutamate-release inhibitor lamotrigine on hippocampal structure and memory were examined in people receiving medically needed prescription corticosteroid therapy. A total of 54 outpatient adults (n = 28 women) receiving chronic (≥ 6 months) oral corticosteroid therapy were randomized to lamotrigine or placebo for 48 weeks. Declarative memory was assessed using the Rey Auditory Verbal Learning Test (RAVLT); structural magnetic resonance imaging (MRI) as well as single-voxel proton MR spectroscopy ( 1 HMRS) focused on hippocampus were obtained at baseline and week 48. Utilizing a mixed-model approach, structural and biochemical data were examined by separate ANOVAs, and memory was assessed with a multi-level longitudinal model. RAVLT total scores demonstrated significantly better declarative memory performance with lamotrigine than placebo (p = 0.047). Hippocampal subfield volumes were not significantly different between the treatment groups. In summary, lamotrigine was associated with less decline in declarative memory performance than placebo in corticosteroid-treated patients. Findings suggest that, in humans as well as in animal models, glutamate release inhibitors may attenuate some of the effects on the human memory associated with corticosteroids.",2019,RAVLT total scores demonstrated significantly better declarative memory performance with lamotrigine than placebo (p = 0.047).,"['people receiving medically needed prescription corticosteroid therapy', '54 outpatient adults (n\u202f=\u202f28 women) receiving chronic (≥\u202f6 months) oral', 'human hippocampus']","['placebo', 'corticosteroid therapy', 'lamotrigine', 'glutamate-release inhibitor lamotrigine', 'lamotrigine or placebo']","['Hippocampal subfield volumes', 'Rey Auditory Verbal Learning Test (RAVLT); structural magnetic resonance imaging (MRI', 'Declarative memory', 'hippocampal structure and memory', 'declarative memory performance', 'memory performance and hippocampal volume']","[{'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C1285654', 'cui_str': 'Ability to remember'}]",54.0,0.322321,RAVLT total scores demonstrated significantly better declarative memory performance with lamotrigine than placebo (p = 0.047).,"[{'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States. Electronic address: Sherwood.Brown@UTSouthwestern.edu.'}, {'ForeName': 'Nasreen', 'Initials': 'N', 'LastName': 'Sayed', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}, {'ForeName': 'Changho', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Department of the Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Tustison', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California, Irvine, United States.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California, Irvine, United States.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Yassa', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California, Irvine, United States.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Enkevort', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Ivleva', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}, {'ForeName': 'Prabha', 'Initials': 'P', 'LastName': 'Sunderajan', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vazquez', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'McEwen', 'Affiliation': 'The Harold and Margaret Milliken Hatch Laboratory of Neuroendocrinology, Rockefeller University, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kulikova', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Frol', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2018.12.012']
60,30790402,"In-office bleaching with a commercial 40% hydrogen peroxide gel modified to have different pHs: Color change, surface morphology, and penetration of hydrogen peroxide into the pulp chamber.","OBJECTIVE


In-office bleaching gels are usually marketed in different pHs. This study is aimed at evaluating the efficacy, enamel surface morphology and concentration of hydrogen peroxide (HP) in the pulp chamber of teeth bleached with 40% HP with different pHs.
MATERIALS AND METHODS


Forty premolars were randomly divided according to bleaching gel pH: 5.1, 6.3, 7.0, and control (no bleaching). Teeth were prepared, an acetate buffer was placed in the pulp chamber and teeth were bleached with two 20-minutes applications. The amount of HP was determined on a UV-VIS spectrophotometer. Color change was assessed by using a digital spectrophotometer before and 1 week after bleaching treatment. Five additional premolars were divided into four parts, assigned to the same groups above for analysis under scanning electron microscope. Data were subjected to anova and Tukey's tests (alpha = 0.05).
RESULTS


The group pH 5.1 showed the highest HP diffusion in the pulp chamber (P < .001). No significant difference was detected in color change (P = .51). All groups presented the same pattern of enamel demineralization.
CONCLUSIONS


The bleaching agent with pH 5.1 presented the highest HP amounts in the pulp chamber, but color change and enamel morphology were similar among groups.
CLINICAL SIGNIFICANCE


Regardless of the pH, the bleaching effect can be observed in teeth submitted to high concentrations of HP, but a higher permeability of HP was found in the pulp chamber of teeth bleached with more acidic bleaching agents. Based on that, we suggest the use of alkaline gels for in-office bleaching to minimize damage to the pulpal tissue.",2022,The group pH 5.1 showed the highest HP diffusion in the pulp chamber (P < .001).,"['Forty premolars', 'pulp chamber of teeth bleached with 40% HP with different pHs']","['bleaching gel pH', 'control (no bleaching', 'hydrogen peroxide (HP']","['highest HP diffusion', 'color change', 'Color change', 'color change and enamel morphology']","[{'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0034099', 'cui_str': 'Pulp Chamber'}, {'cui': 'C0303749', 'cui_str': 'Bleach (substance)'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0475330', 'cui_str': 'Color change (qualifier value)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0543482', 'cui_str': 'morphology'}]",40.0,0.0172555,The group pH 5.1 showed the highest HP diffusion in the pulp chamber (P < .001).,"[{'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Acuña', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Uvaranas, Ponta Grossa, Paraná - Brazil.'}, {'ForeName': 'Sibelli O', 'Initials': 'SO', 'LastName': 'Parreiras', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Uvaranas, Ponta Grossa, Paraná - Brazil.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Favoreto', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Uvaranas, Ponta Grossa, Paraná - Brazil.'}, {'ForeName': 'Gustavo P', 'Initials': 'GP', 'LastName': 'Cruz', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Uvaranas, Ponta Grossa, Paraná - Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Gomes', 'Affiliation': 'Department of Applied Chemistry, School of Chemistry State University of Ponta Grossa, Uvaranas, Ponta Grossa, Paraná - Brazil.'}, {'ForeName': 'Christiane P F', 'Initials': 'CPF', 'LastName': 'Borges', 'Affiliation': 'Department of Chemistry, State University of Ponta Grossa, Uvaranas, Ponta Grossa, Paraná - Brazil.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Uvaranas, Ponta Grossa, Paraná - Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Uvaranas, Ponta Grossa, Paraná - Brazil.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12453']
61,29248433,Physiotherapy breathing retraining for asthma: a randomised controlled trial.,"BACKGROUND


Despite effective pharmacotherapy, asthma continues to impair quality of life for most patients. Non-pharmacological approaches, including breathing retraining, are therefore of great interest to patients. However, clinicians rarely advocate breathing retraining and access to this intervention is restricted for most patients due to the limited availability of suitable physiotherapists and poor integration of breathing retraining into standard care. We aimed to assess the effectiveness of a digital self-guided breathing retraining intervention.
METHODS


In this randomised controlled trial, we recruited patients from 34 general practices in the UK. Eligibility criteria for patients with asthma were broad, comprising a physician diagnosis of asthma, age of 16-70 years, receipt of at least one anti-asthma medication in the previous year, and impaired asthma-related quality of life (Asthma Quality of Life Questionnaire [AQLQ] score of <5·5). We developed a self-guided intervention, which was delivered as a DVD plus a printed booklet (DVDB). Participants were randomly assigned to receive either the DVDB intervention, three face-to-face breathing retraining sessions, or standard care, in a 2:1:2 ratio, for 12 months. Randomisation was achieved using the Southampton Clinical Trials Unit telephone randomisation service by use of random number generators. The primary outcome was the AQLQ score in the intention-to-treat population at 12 months. The trial was powered to show equivalence between the two active intervention groups, and superiority of both intervention groups over usual care. Secondary outcomes included patient-reported and physiological measures of asthma control, patient acceptability, and health-care costs. This trial was registered with International Standard Randomised Controlled Trial Number registry, number ISRCTN88318003.
FINDINGS


Between Nov 5, 2012 and Jan 28, 2014, invitations to participate in the study were sent to 15 203 patients with general practitioner-diagnosed asthma, of whom 655 were recruited into the study. AQLQ scores at 12 months were significantly higher in the DVDB group (mean 5·40, SD 1·14) than in the usual care group (5·12, SD 1·17; adjusted mean difference 0·28, 95% CI 0·11 to 0·44), and in the face-to-face group (5·33, SD 1·06) than in the usual care group (adjusted mean difference 0·24, 95% CI 0·04 to 0·44); AQLQ scores were similar between the DVDB group and the face-to-face group (0·04, 95% CI -0·16 to 0·24). There were no significant differences between the randomisation groups in FEV1 or fraction of exhaled nitric oxide. 744 adverse events occurred in 272 patients: 101 (39%) of 261 patients in the DVDB group, 55 (42%) of 132 patients in the face-to-face group, and 132 (50%) of 262 in the usual care group, with patients reporting one or more event. 11 (4%) patients in the DVDB group, four (3%) patients in the face-to-face group, and 20 (8%) patients in the usual care group had a serious adverse event.
INTERPRETATION


Breathing retraining programmes improve quality of life in patients with incompletely controlled asthma despite having little effect on lung function or airway inflammation. Such programmes can be delivered conveniently and cost-effectively as a self-guided digital audiovisual programme, so might also reduce health-care costs.
FUNDING


UK National Institute of Health Research.",2018,There were no significant differences between the randomisation groups in FEV1 or fraction of exhaled nitric oxide.,"['asthma', 'Between Nov 5, 2012 and Jan 28, 2014', '203 patients with general practitioner-diagnosed asthma, of whom 655 were recruited into the study', 'patients with asthma were broad, comprising a physician diagnosis of asthma, age of 16-70 years, receipt of at least one anti-asthma medication in the previous year, and impaired asthma-related', 'recruited patients from 34 general practices in the UK', 'patients with incompletely controlled asthma despite having little effect on lung function or airway inflammation']","['Physiotherapy breathing retraining', 'digital self-guided breathing retraining intervention', 'Breathing retraining programmes', 'DVDB', 'DVDB intervention, three face-to-face breathing retraining sessions, or standard care']","['AQLQ score in the intention-to-treat population', '744 adverse events', 'serious adverse event', 'quality of life (Asthma Quality of Life Questionnaire [AQLQ] score of <5·5', 'patient-reported and physiological measures of asthma control, patient acceptability, and health-care costs', 'quality of life', 'FEV1 or fraction of exhaled nitric oxide', 'AQLQ scores']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0700321', 'cui_str': 'Small (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034380'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}]",15203.0,0.119156,There were no significant differences between the randomisation groups in FEV1 or fraction of exhaled nitric oxide.,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bruton', 'Affiliation': 'Faculty of Health Sciences, University of Southampton, Southampton, UK; NIHR Southampton Biomedical Research Centre, Southampton, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Faculty of Social, Human & Mathematical Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Raftery', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Arden-Close', 'Affiliation': 'Faculty of Science and Technology, Bournemouth University, Poole, Dorset, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kirby', 'Affiliation': 'Faculty of Social, Human & Mathematical Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Manimekalai', 'Initials': 'M', 'LastName': 'Thiruvothiyur', 'Affiliation': 'Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Webley', 'Affiliation': 'NIHR Southampton Clinical Trials Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'NIHR Southampton Clinical Trials Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Gibson', 'Affiliation': 'Therapy Department, Southampton General Hospital, University of Southampton, Southampton, UK.'}, {'ForeName': 'Guiqing', 'Initials': 'G', 'LastName': 'Yao', 'Affiliation': 'Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Stafford-Watson', 'Affiliation': 'NIHR Collaboration for Leadership in Applied Health Research Centre Wessex, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Versnel', 'Affiliation': 'Asthma UK, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ratko', 'Initials': 'R', 'LastName': 'Djukanovic', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK; NIHR Southampton Biomedical Research Centre, Southampton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'Respiratory Medicine Unit and Oxford NIHR Biomedical Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Holgate', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, Southampton, UK; Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; Asthma UK Centre for Applied Research, University of Edinburgh, Edinburgh, UK. Electronic address: d.m.thomas@soton.ac.uk.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(17)30474-5']
62,17689142,Enhancement of sleep stability with Tai Chi exercise in chronic heart failure: preliminary findings using an ECG-based spectrogram method.,"OBJECTIVE


To assess the effects of a 12-week Tai Chi exercise program on sleep using the sleep spectrogram, a method based on a single channel electrocardiogram (ECG)-derived estimation of cardiopulmonary coupling, previously shown to identify stable and unstable sleep states.
METHODS


We retrospectively analyzed 24-h continuous ECG data obtained in a clinical trial of Tai Chi exercise in patients with heart failure. Eighteen patients with chronic stable heart failure, left ventricular ejection fraction <or= 40% (mean [+/-standard deviation] age, 59+/-14 years, mean baseline ejection fraction 24%+/-8%, mean) were randomly assigned to receive usual care (N=10), which included pharmacological therapy and dietary and exercise counseling, or 12 weeks of Tai Chi training (N=8) in addition to usual care. Using the ECG-based sleep spectrogram, we compared intervention and control groups by evaluating baseline and 12-week high (stable) and low (unstable) frequency coupling (HFC & LFC, respectively) as a percentage of estimated total sleep time (ETST).
RESULTS


At 12 weeks, those who participated in Tai Chi showed a significant increase in HFC (+0.05+/-0.10 vs. -0.06+/-0.09 % ETST, p=0.04) and significant reduction in LFC (-0.09+/-0.09 vs. +0.13+/-0.13 % ETST, p<0.01), compared to patients in the control group. Correlations were seen between improved sleep stability and better disease-specific quality of life.
CONCLUSIONS


Tai Chi exercise may enhance sleep stability in patients with chronic heart failure. This sleep effect may have a beneficial impact on blood pressure, arrhythmogenesis and quality of life.",2008,"At 12 weeks, those who participated in Tai Chi showed a significant increase in HFC (+0.05+/-0.10 vs. -0.06+/-0.09 % ETST, p=0.04) and significant reduction in LFC (-0.09+/-0.09 vs. +0.13+/-0.13 % ETST, p<0.01), compared to patients in the control group.","['Eighteen patients with chronic stable heart failure, left ventricular ejection fraction <or= 40% (mean [+/-standard deviation] age, 59+/-14 years, mean baseline ejection fraction 24%+/-8%, mean', 'patients with chronic heart failure', 'chronic heart failure', 'patients with heart failure']","['Tai Chi exercise', 'Tai Chi exercise program', 'pharmacological therapy and dietary and exercise counseling, or 12 weeks of Tai Chi training (N=8) in addition to usual care', 'usual care']","['total sleep time (ETST', 'blood pressure, arrhythmogenesis and quality of life', 'LFC', 'sleep stability', 'sleep stability and better disease-specific quality of life', 'HFC']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0034380'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",18.0,0.0272366,"At 12 weeks, those who participated in Tai Chi showed a significant increase in HFC (+0.05+/-0.10 vs. -0.06+/-0.09 % ETST, p=0.04) and significant reduction in LFC (-0.09+/-0.09 vs. +0.13+/-0.13 % ETST, p<0.01), compared to patients in the control group.","[{'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Division for Research and Education in Complementary and Integrative Medical Therapies, Harvard Medical School, Boston, MA 02215, USA. gyeh@hms.harvard.edu'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Mietus', 'Affiliation': ''}, {'ForeName': 'Chung-Kang', 'Initials': 'CK', 'LastName': 'Peng', 'Affiliation': ''}, {'ForeName': 'Russell S', 'Initials': 'RS', 'LastName': 'Phillips', 'Affiliation': ''}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ''}, {'ForeName': 'Ary L', 'Initials': 'AL', 'LastName': 'Goldberger', 'Affiliation': ''}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Thomas', 'Affiliation': ''}]",Sleep medicine,[]
63,26331103,Impact of Short- and Long-term Tai Chi Mind-Body Exercise Training on Cognitive Function in Healthy Adults: Results From a Hybrid Observational Study and Randomized Trial.,"BACKGROUND


Cognitive decline amongst older adults is a significant public health concern. There is growing interest in behavioral interventions, including exercise, for improving cognition. Studies to date suggest tai chi (TC) may be a safe and potentially effective exercise for preserving cognitive function with aging; however, its short-term and potential long-term impact on physically active, healthy adults is unclear.
OBJECTIVE


To compare differences in cognitive function among long-term TC expert practitioners and age-matched and gender-matched TC-naïve adults and to determine the effects of short-term TC training on measures of cognitive function in healthy, nonsedentary adults.
DESIGN


A hybrid design including an observational comparison and a 2-arm randomized clinical trial (RCT).
PARTICIPANTS


Healthy, nonsedentary, TC-naive adults (50 y-79 y) and age-matched and gender-matched long-term TC experts.
METHODS


A cross-sectional comparison of cognitive function in healthy TC-naïve (n=60) and TC expert (24.5 y ÷ 12 y experience; n=27) adults: TC-naïve adults then completed a 6-month, 2-arm, wait-list randomized clinical trial of TC training. Six measures of cognitive function were assessed for both cross-sectional and longitudinal comparisons.
RESULTS


TC experts exhibited trends towards better scores on all cognitive measures, significantly so for category fluency (P=.01), as well as a composite z score summarizing all 6 cognitive assessments (P=.03). In contrast, random assignment to 6 months of TC training in TC-naïve adults did not significantly improve any measures of cognitive function.
CONCLUSIONS


In healthy nonsedentary adults, long-term TC training may help preserve cognitive function; however, the effect of short-term TC training in healthy adults remains unclear.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01340365.",2015,"RESULTS


TC experts exhibited trends towards better scores on all cognitive measures, significantly so for category fluency (P=.01), as well as a composite z score summarizing all 6 cognitive assessments (P=.03).","['A cross-sectional comparison of cognitive function in healthy TC-naïve (n=60) and TC expert (24.5 y ÷ 12 y experience; n=27) adults: TC-naïve adults', 'Healthy, nonsedentary, TC-naive adults (50 y-79 y) and age-matched and gender-matched long-term TC experts', 'healthy nonsedentary adults', 'healthy adults', 'Healthy Adults', 'older adults', 'healthy, nonsedentary adults', 'long-term TC expert practitioners and age-matched and gender-matched TC-naïve adults']","['short-term TC training', 'Short- and Long-term Tai Chi Mind-Body Exercise Training', 'TC training', 'tai chi (TC']","['cognitive function', 'Cognitive Function']","[{'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",,0.038322,"RESULTS


TC experts exhibited trends towards better scores on all cognitive measures, significantly so for category fluency (P=.01), as well as a composite z score summarizing all 6 cognitive assessments (P=.03).","[{'ForeName': 'Jacquelyn N', 'Initials': 'JN', 'LastName': 'Walsh', 'Affiliation': ""Osher Center for Integrative Medicine, Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts, United States (Ms Walsh).""}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'Harvard Medical School, Boston, United States (Dr Manor).'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hausdorff', 'Affiliation': 'Movement Disorders Unit, Department of Neurology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel (Dr Hausdorff).'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Novak', 'Affiliation': 'Harvard Medical School, Boston, United States (Dr Novak).'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Lipsitz', 'Affiliation': 'Harvard Medical School, Boston, United States (Dr Lipsitz).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Gow', 'Affiliation': ""Osher Center for Integrative Medicine, Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts, United States (Mr Gow).""}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Harvard Medical School, Boston, United States (Dr Macklin).'}, {'ForeName': 'Chung-Kang', 'Initials': 'CK', 'LastName': 'Peng', 'Affiliation': 'Harvard Medical School, Boston, United States (Dr Peng).'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts, United States (Dr Wayne).""}]",Global advances in health and medicine,['10.7453/gahmj.2015.058']
64,23864006,"Intervention for recoarctation in the single ventricle reconstruction trial: incidence, risk, and outcomes.","BACKGROUND


Recoarctation after the Norwood procedure increases risk for mortality. The Single Ventricle Reconstruction (SVR) trial randomized subjects with a single right ventricle undergoing a Norwood procedure to a modified Blalock-Taussig shunt or a right ventricle-pulmonary artery shunt. We sought to determine the incidence of recoarctation, risk factors, and outcomes in the SVR trial.
METHODS AND RESULTS


Recoarctation was defined by intervention, either catheter based or surgical. Univariate analysis and multivariable Cox proportional hazard models were performed with adjustment for center. Of the 549 SVR subjects, 97 (18%) underwent 131 interventions (92 balloon aortoplasty, 39 surgical) for recoarctation at a median age of 4.9 months (range, 1.1-10.5 months). Intervention typically occurred at pre-stage II catheterization (n=71, 54%) or at stage II surgery (n=38, 29%). In multivariable analysis, recoarctation was associated with the shunt type in place at the end of the Norwood procedure (hazard ratio, 2.0 for right ventricle-pulmonary artery shunt versus modified Blalock-Taussig shunt; P=0.02), and Norwood discharge peak echo-Doppler arch gradient (hazard ratio, 1.07 per 1 mm Hg; P<0.01). Subjects with recoarctation demonstrated comorbidities at pre-stage II evaluation, including higher pulmonary arterial pressures (15.4±3.0 versus 14.5±3.5 mm Hg; P=0.05), higher pulmonary vascular resistance (2.6±1.6 versus 2.0±1.0 Wood units·m(2); P=0.04), and increased echocardiographic volumes (end-diastolic volume, 126±39 versus 112±33 mL/BSA(1.3), where BSA is body surface area; P=0.02). There was no difference in 12-month postrandomization transplantation-free survival between those with and without recoarctation (P=0.14).
CONCLUSIONS


Recoarctation is common after Norwood and contributes to pre-stage II comorbidities. Although with intervention there is no associated increase in 1-year transplantation/mortality, further evaluation is warranted to evaluate the effects of associated morbidities.",2013,"There was no difference in 12-month postrandomization transplantation-free survival between those with and without recoarctation (P=0.14).
",['549 SVR subjects'],['single right ventricle undergoing a Norwood procedure to a modified Blalock-Taussig shunt or a right ventricle-pulmonary artery shunt'],"['12-month postrandomization transplantation-free survival', '1-year transplantation/mortality', 'pulmonary vascular resistance', 'echocardiographic volumes', 'pulmonary arterial pressures']",[],"[{'cui': 'C0546268', 'cui_str': 'Single right ventricle'}, {'cui': 'C2242650', 'cui_str': 'Norwood Procedures'}, {'cui': 'C0397561', 'cui_str': 'Modified Blalock-Taussig Procedure'}, {'cui': 'C0225883', 'cui_str': 'Right Ventricle'}, {'cui': 'C0183290', 'cui_str': 'Pulmonary artery shunt'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1168098', 'cui_str': 'Pulmonary arterial pressure'}]",549.0,0.137881,"There was no difference in 12-month postrandomization transplantation-free survival between those with and without recoarctation (P=0.14).
","[{'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Clinical Research Institute, Duke University Medical Center, 2400 Pratt St., Durham, NC 27705, USA. Kevin.hill@duke.edu'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Rhodes', 'Affiliation': ''}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Aiyagari', 'Affiliation': ''}, {'ForeName': 'G Hamilton', 'Initials': 'GH', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bergersen', 'Affiliation': ''}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Chai', 'Affiliation': ''}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fleming', 'Affiliation': ''}, {'ForeName': 'J Curt', 'Initials': 'JC', 'LastName': 'Fudge', 'Affiliation': ''}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gillespie', 'Affiliation': ''}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Gray', 'Affiliation': ''}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'Hirsch', 'Affiliation': ''}, {'ForeName': 'Kyong-Jin', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Ohye', 'Affiliation': ''}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Oster', 'Affiliation': ''}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Pasquali', 'Affiliation': ''}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Pelech', 'Affiliation': ''}, {'ForeName': 'Wolfgang A K', 'Initials': 'WA', 'LastName': 'Radtke', 'Affiliation': ''}, {'ForeName': 'Cheryl M', 'Initials': 'CM', 'LastName': 'Takao', 'Affiliation': ''}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Vincent', 'Affiliation': ''}, {'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.112.000488']
65,30093866,"One-Year Consumption of a Mediterranean-Like Dietary Pattern With Vitamin D3 Supplements Induced Small Scale but Extensive Changes of Immune Cell Phenotype, Co-receptor Expression and Innate Immune Responses in Healthy Elderly Subjects: Results From the United Kingdom Arm of the NU-AGE Trial.","Amongst the major features of aging are chronic low grade inflammation and a decline in immune function. The Mediterranean diet (MedDiet) is considered to be a valuable tool to improve health status, and although beneficial effects have been reported, to date, immunological outcomes have not been extensively studied. We aimed to test the hypothesis that 1 year of a tailored intervention based on the MedDiet with vitamin D (10 μg/day) would improve innate immune responses in healthy elderly subjects (65-79 years) from the English cohort (272 subjects recruited) of the NU-AGE randomized, controlled study (clinicaltrials.gov, NCT01754012). Of the 272 subjects forming the United Kingdom cohort a subgroup of 122 subjects (61 in the intervention group and 61 in the control group) was used to evaluate  ex vivo  innate immune response, phenotype of circulating immune cells, and levels of pro- and anti-inflammatory markers. Odds Ratio (OR) was calculated for all the parameters analyzed. After adjustment by gender, MedDiet-females with a BMI < 31 kg/m 2  had a significant upregulation of circulating CD40 + CD86 +  cells (OR 3.44, 95% CI 1.01-11.75,  P  = 0.0437). Furthermore, in all MedDiet subjects, regardless of gender, we observed a MedDiet-dependent changes, although not statistically significant of immune-critical parameters including T cell degranulation, cytokine production and co-receptor expression. Overall, our study showed that adherence to an individually tailored Mediterranean-like dietary pattern with a daily low dose of vitamin D3 supplements for 1 year modified a large variety of parameters of immune function in healthy, elderly subjects. We interpreted these data as showing that the MedDiet in later life could improve aspects of innate immunity and thus it could aid the design of strategies to counteract age-associated disturbances.  Clinical Trial Registration:  clinicaltrials.gov, NCT01754012.",2018,"After adjustment by gender, MedDiet-females with a BMI < 31 kg/m 2  had a significant upregulation of circulating CD40 + CD86 +  cells (OR 3.44, 95% CI 1.01-11.75,  P  = 0.0437).","['healthy elderly subjects (65-79 years) from the English cohort (272 subjects recruited) of the NU-AGE', '272 subjects forming the United Kingdom cohort a subgroup of 122 subjects (61 in the intervention group and 61 in the control group', 'Healthy Elderly Subjects', 'healthy, elderly subjects']","['MedDiet with vitamin D', 'Mediterranean-Like Dietary Pattern With Vitamin D3 Supplements', 'vitamin D3 supplements']","['Immune Cell', 'innate immune responses', 'ex vivo  innate immune response, phenotype of circulating immune cells, and levels of pro- and anti-inflammatory markers', 'Odds Ratio (OR', 'T cell degranulation, cytokine production and co-receptor expression', 'circulating CD40 + CD86 +  cells']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0020969', 'cui_str': 'Innate Immune Response'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0033268'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",272.0,0.0400413,"After adjustment by gender, MedDiet-females with a BMI < 31 kg/m 2  had a significant upregulation of circulating CD40 + CD86 +  cells (OR 3.44, 95% CI 1.01-11.75,  P  = 0.0437).","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Maijo', 'Affiliation': 'Gut Health Programme, Institute Strategic Programme, Quadram Institute Bioscience, Norwich, United Kingdom.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Ivory', 'Affiliation': 'Gut Health Programme, Institute Strategic Programme, Quadram Institute Bioscience, Norwich, United Kingdom.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Clements', 'Affiliation': 'Gut Health Programme, Institute Strategic Programme, Quadram Institute Bioscience, Norwich, United Kingdom.'}, {'ForeName': 'Jack R', 'Initials': 'JR', 'LastName': 'Dainty', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Jennings', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Gillings', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Fairweather-Tait', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Gulisano', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Aurelia', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Franceschi', 'Affiliation': 'C.I.G. Interdepartmental Centre ""L. Galvani"", University of Bologna, Bologna, Italy.'}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Carding', 'Affiliation': 'Gut Health Programme, Institute Strategic Programme, Quadram Institute Bioscience, Norwich, United Kingdom.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Nicoletti', 'Affiliation': 'Gut Health Programme, Institute Strategic Programme, Quadram Institute Bioscience, Norwich, United Kingdom.'}]",Frontiers in physiology,['10.3389/fphys.2018.00997']
66,29020106,"Can Tai Chi training impact fractal stride time dynamics, an index of gait health, in older adults? Cross-sectional and randomized trial studies.","PURPOSE


To determine if Tai Chi (TC) has an impact on long-range correlations and fractal-like scaling in gait stride time dynamics, previously shown to be associated with aging, neurodegenerative disease, and fall risk.
METHODS


Using Detrended Fluctuation Analysis (DFA), this study evaluated the impact of TC mind-body exercise training on stride time dynamics assessed during 10 minute bouts of overground walking. A hybrid study design investigated long-term effects of TC via a cross-sectional comparison of 27 TC experts (24.5 ± 11.8 yrs experience) and 60 age- and gender matched TC-naïve older adults (50-70 yrs). Shorter-term effects of TC were assessed by randomly allocating TC-naïve participants to either 6 months of TC training or to a waitlist control. The alpha (α) long-range scaling coefficient derived from DFA and gait speed were evaluated as outcomes.
RESULTS


Cross-sectional comparisons using confounder adjusted linear models suggest that TC experts exhibited significantly greater long-range scaling of gait stride time dynamics compared with TC-naïve adults. Longitudinal random-slopes with shared baseline models accounting for multiple confounders suggest that the effects of shorter-term TC training on gait dynamics were not statistically significant, but trended in the same direction as longer-term effects although effect sizes were very small. In contrast, gait speed was unaffected in both cross-sectional and longitudinal comparisons.
CONCLUSION


These preliminary findings suggest that fractal-like measures of gait health may be sufficiently precise to capture the positive effects of exercise in the form of Tai Chi, thus warranting further investigation. These results motivate larger and longer-duration trials, in both healthy and health-challenged populations, to further evaluate the potential of Tai Chi to restore age-related declines in gait dynamics.
TRIAL REGISTRATION


The randomized trial component of this study was registered at ClinicalTrials.gov (NCT01340365).",2017,Shorter-term effects of TC were assessed by randomly allocating TC-naïve participants to either 6 months of TC training or to a waitlist control.,"['27 TC experts (24.5 ± 11.8 yrs experience) and 60 age- and gender matched TC-naïve older adults (50-70 yrs', 'older adults']","['TC', 'TC mind-body exercise training', 'TC training', 'Tai Chi (TC']","['gait dynamics', 'gait speed', 'gait stride time dynamics']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]",,0.0479616,Shorter-term effects of TC were assessed by randomly allocating TC-naïve participants to either 6 months of TC training or to a waitlist control.,"[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Gow', 'Affiliation': ""Osher Center for Integrative Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.""}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': 'Center for the Study of Movement, Cognition, and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Sagol School of Neuroscience and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'Division of Gerontology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Division of Gerontology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bonato', 'Affiliation': 'Motion Analysis Laboratory, Spaulding Rehabilitation Hospital, and the Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Novak', 'Affiliation': 'Division of Gerontology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Chung-Kang', 'Initials': 'CK', 'LastName': 'Peng', 'Affiliation': 'Division of Interdisciplinary Medicine and Biotechnology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Ahn', 'Affiliation': 'Division of Interdisciplinary Medicine and Biotechnology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.""}]",PloS one,['10.1371/journal.pone.0186212']
67,29857136,Gastric emptying and intestinal appearance of nonabsorbable drugs phenol red and paromomycin in human subjects: A multi-compartment stomach approach.,"The goal of this study was to create a mass transport model (MTM) model for gastric emptying and upper gastrointestinal (GI) appearance that can capture the in vivo concentration-time profiles of the nonabsorbable drug phenol red in solution in the stomach and upper small intestine by direct luminal measurement while simultaneously recording the contractile activity (motility) via manometry. We advanced from a one-compartmental design of the stomach to a much more appropriate, multi-compartmental 'mixing tank' gastric model that reflects drug distribution along the different regions of the stomach as a consequence of randomly dosing relative to the different contractile phases of the migrating motor complex (MMC). To capture the intraluminal phenol red concentrations in the different segments of the GI tract both in fasted and fed state conditions, it was essential to include a bypass flow compartment ('magenstrasse') to facilitate the transport of the phenol red solution directly to the duodenum (fasted state) or antrum (fed state). The fasted and fed state models were validated with external reference data from an independent aspiration study using another nonabsorbable marker (paromomycin). These results will be essential for the development and optimization of computational programs for GI simulation and absorption prediction, providing a realistic gastric physiologically-based pharmacokinetic (PBPK) model based on direct measurement of gastric concentrations of the drug in the stomach.",2018,"To capture the intraluminal phenol red concentrations in the different segments of the GI tract both in fasted and fed state conditions, it was essential to include a bypass flow compartment ('magenstrasse') to facilitate the transport of the phenol red solution directly to the duodenum (fasted state) or antrum (fed state).",['human subjects'],"['nonabsorbable drugs phenol red and paromomycin', 'nonabsorbable marker (paromomycin']",['Gastric emptying and intestinal appearance'],"[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0031430', 'cui_str': 'Phenolsulfonphthalein'}, {'cui': 'C0030576', 'cui_str': 'Paromomycin'}]","[{'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}]",,0.0200957,"To capture the intraluminal phenol red concentrations in the different segments of the GI tract both in fasted and fed state conditions, it was essential to include a bypass flow compartment ('magenstrasse') to facilitate the transport of the phenol red solution directly to the duodenum (fasted state) or antrum (fed state).","[{'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Paixão', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA; Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Av. Professor Gama Pinto, 1649-003 Lisboa, Portugal.'}, {'ForeName': 'Marival', 'Initials': 'M', 'LastName': 'Bermejo', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA; Department Engineering Pharmacy Section, Miguel Hernandez University, San Juan de Alicante, 03550 Alicante, Spain.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Hens', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA; Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tsume', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Dickens', 'Affiliation': 'Department of Statistics, University of Michigan 48109 Ann Arbor, USA.'}, {'ForeName': 'Kerby', 'Initials': 'K', 'LastName': 'Shedden', 'Affiliation': 'Department of Statistics, University of Michigan 48109 Ann Arbor, USA.'}, {'ForeName': 'Niloufar', 'Initials': 'N', 'LastName': 'Salehi', 'Affiliation': 'Center for the Study of Complex Systems and Department of Chemical Engineering, University of Michigan, Ann Arbor, MI 48109-2136, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Koenigsknecht', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Baker', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Hasler', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lionberger', 'Affiliation': 'Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Jianghong', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Wysocki', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wen', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Frances', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Amidon', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Yu', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Benninghoff', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Raimar', 'Initials': 'R', 'LastName': 'Löbenberg', 'Affiliation': 'Faculty of Pharmacy & Pharmaceutical Sciences, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Arjang', 'Initials': 'A', 'LastName': 'Talattof', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Duxin', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Gordon L', 'Initials': 'GL', 'LastName': 'Amidon', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI 48109, USA. Electronic address: glamidon@med.umich.edu.'}]",European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V,['10.1016/j.ejpb.2018.05.033']
68,28203723,RETRACTED: Addition of transversus thoracic muscle plane block to pectoral nerves block provides more effective perioperative pain relief than pectoral nerves block alone for breast cancer surgery,,2017,The visual analog scale pain scores were lower in the PT group than the C group.,"['Methods\n\n\nSeventy adult female patients undergoing unilateral mastectomy under general anaesthesia', 'breast cancer surgery', 'patients undergoing mastectomy']","['transversus thoracic muscle plane block to pectoral nerves block', 'PECS and TTP blocks', 'PECS and TTP blocks (PT group, n=35) or the PECS block']","['sensory level loss confirmed by cold tests and additional analgesic drugs within 24\u2009h after the operation', 'sensory loss', 'visual analog scale pain score', 'visual analog scale pain scores']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0034155', 'cui_str': 'Moschkowitz Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1262068', 'cui_str': 'Sensory level'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0278134', 'cui_str': 'Absence of sensation (finding)'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}]",70.0,0.0903681,The visual analog scale pain scores were lower in the PT group than the C group.,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ueshima', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Otake', 'Affiliation': ''}]",British journal of anaesthesia,['10.1093/bja/aew449']
69,25933919,Maximizing the utility of a single site randomized controlled psychotherapy trial.,"PURPOSE OF THE RESEARCH


There is increasing interest in including measures of biological mechanisms as mediators and moderators of treatment outcome in randomized controlled trials (RCT's) of psychotherapy efficacy. However, examining biological mechanisms is often expensive and budget caps of most major funding agencies have remained stable in recent years. The goal of this manuscript is to describe how a psychotherapy efficacy trial is using a model of collaborative, affiliated grants to maximize resources and the potential knowledge to be gained from a single site RCT. Principal results and conclusions: The trial is an ongoing RCT comparing two psychotherapies for the treatment of concurrent posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) with a sample of treatment seeking veterans. Through collaboration with a team of investigators with independently-funded but affiliated grants, measures of select sleep, neurobiological, and genetic biomarkers were integrated into this single site RCT. This model has allowed us to pose research questions regarding the role of biological mechanisms, maximize the utility of recruitment, and be efficient in maximizing knowledge to be gained in a way that would not be possible solely on the funding of a single site RCT. Challenges of this model include high participant burden in regard to assessment and complicated coordinating procedures among studies. Strategies to address these challenges are described.",2015,: The trial is an ongoing RCT comparing two psychotherapies for the treatment of concurrent posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) with a sample of treatment seeking veterans.,['concurrent posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) with a sample of treatment seeking veterans'],[],[],"[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]",[],[],,0.0386948,: The trial is an ongoing RCT comparing two psychotherapies for the treatment of concurrent posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) with a sample of treatment seeking veterans.,"[{'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States; National Center for PTSD, 215 North Main Street, White River Junction, VT 05009, United States. Electronic address: snorman@ucsd.edu.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Haller', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States. Electronic address: moira.haller@va.gov.'}, {'ForeName': 'Andrea D', 'Initials': 'AD', 'LastName': 'Spadoni', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States. Electronic address: aspadoni@ucsd.edu.'}, {'ForeName': 'Sean P A', 'Initials': 'SP', 'LastName': 'Drummond', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States; Monash University, School of Psychological Sciences, Wellington Road, Clayton, VIC 3800, Australia. Electronic address: sean.drummond@monash.edu.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Risbrough', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States. Electronic address: vrisbrough@ucsd.edu.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Hamblen', 'Affiliation': 'National Center for PTSD, 215 North Main Street, White River Junction, VT 05009, United States; Geisel School of Medicine at Dartmouth, Department of Psychiatry, Dartmouth-Hitchcock Medical Center, 1 Medical Center Drive, Lebanon, NH 03756, United States. Electronic address: Jessica.l.hamblen@dartmouth.edu.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Trim', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States. Electronic address: rstrim@ucsd.edu.'}, {'ForeName': 'Erika X', 'Initials': 'EX', 'LastName': 'Blanes', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States. Electronic address: erika.blanes@va.gov.'}]",Contemporary clinical trials,['10.1016/j.cct.2015.04.011']
70,32492293,A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19.,"BACKGROUND


Coronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are exposed, the standard of care is observation and quarantine. Whether hydroxychloroquine can prevent symptomatic infection after SARS-CoV-2 exposure is unknown.
METHODS


We conducted a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis. We enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Within 4 days after exposure, we randomly assigned participants to receive either placebo or hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days). The primary outcome was the incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days.
RESULTS


We enrolled 821 asymptomatic participants. Overall, 87.6% of the participants (719 of 821) reported a high-risk exposure to a confirmed Covid-19 contact. The incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]); the absolute difference was -2.4 percentage points (95% confidence interval, -7.0 to 2.2; P = 0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
CONCLUSIONS


After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668.).",2020,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
","['United States and parts of Canada testing', '821 asymptomatic participants', 'enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure']","['placebo', 'Hydroxychloroquine', 'placebo or hydroxychloroquine', 'hydroxychloroquine']","['Side effects', 'incidence of new illness compatible with Covid-19', 'incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days', 'serious adverse reactions']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0454979', 'cui_str': 'Part of Canada'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0028798', 'cui_str': 'Exposure, Occupational'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",821.0,0.751633,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'LaBar', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ilan S', 'Initials': 'IS', 'LastName': 'Schwartz', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}]",The New England journal of medicine,['10.1056/NEJMoa2016638']
71,31609666,Improving Transition to Adulthood for Students with Autism: A Randomized Controlled Trial of STEPS.,"Emerging adulthood is a period of heightened risk for young people with autism spectrum disorder (ASD). Due in part to a lack of evidence-based services and supports during the transition to adulthood, many emerging adults fail to matriculate into postsecondary education or thrive in productive employment. The Stepped Transition in Education Program for Students with ASD (STEPS) was developed to address the psychosocial, transition-related needs of emerging adults with ASD. Adolescents and emerging adults ( n  = 59) with ASD were randomly assigned to either STEPS or transition as usual (TAU). Results indicate that STEPS is acceptable to young people with ASD and their parents and that it can be implemented with high fidelity. Among secondary school students, those who completed STEPS exhibited significantly greater gains in transition readiness from high school, and these gains were largely sustained after program completion. Among students enrolled in postsecondary education, STEPS resulted in increased levels of student adaptation to college relative to those in TAU. Programming to address ASD-related challenges can promote successful educational transitions.",2021,Results indicate that STEPS is acceptable to young people with ASD and their parents and that it can be implemented with high fidelity.,"['Students with Autism', 'young people with autism spectrum disorder (ASD', 'Students with ASD (STEPS', 'secondary school students', 'young people with ASD and their parents', 'Adolescents and emerging adults ( n  =\xa059) with ASD']","['STEPS or transition as usual (TAU', 'STEPS']","['levels of student adaptation', 'gains in transition readiness']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}]",,0.0357795,Results indicate that STEPS is acceptable to young people with ASD and their parents and that it can be implemented with high fidelity.,"[{'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'White', 'Affiliation': 'Center for Youth Development and Intervention, Department of Psychology, University of Alabama.'}, {'ForeName': 'Isaac C', 'Initials': 'IC', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, Virginia Tech.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Education, Virginia Tech.'}, {'ForeName': 'Caitlin M', 'Initials': 'CM', 'LastName': 'Conner', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Elias', 'Affiliation': 'Department of Psychology, Virginia Tech.'}, {'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Capriola-Hall', 'Affiliation': 'Center for Youth Development and Intervention, Department of Psychology, University of Alabama.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2019.1669157']
72,32414405,"""[Repeat] testing and counseling is one of the key [services] that the government should continue providing"": participants' perceptions on extended repeat HIV testing and enhanced counseling (ERHTEC) for primary HIV prevention in pregnant and lactating women in the PRIMAL study, Uganda.","BACKGROUND


The 'Primary HIV Prevention among Pregnant and Lactating Ugandan Women' (PRIMAL) randomized controlled trial aimed to assess an enhanced counseling strategy linked to extended postpartum repeat HIV testing and enhanced counseling among 820 HIV-negative pregnant and lactating women aged 18-49 years and 410 of their male partners to address the first pillar of the WHO Global Strategy for the Prevention of Mother-to-Child HIV transmission (PMTCT). This paper presents findings of qualitative studies aimed at evaluating participants' and service providers' perceptions on the acceptability and feasibility of the intervention and at understanding the effects of the intervention on risk reduction, couple communication, and emotional support from women's partners.
METHODS


PRIMAL Study participants were enrolled from two antenatal care clinics and randomized 1:1 to an intervention or control arm. Both arms received repeat sexually transmitted infections (STI) and HIV testing at enrolment, labor and delivery, and at 3, 6, 12, 18 and 24 months postpartum. The intervention consisted of enhanced quarterly counseling on HIV risk reduction, couple communication, family planning and nutrition delivered by study counselors through up to 24 months post-partum. Control participants received repeat standard post-test counseling. Qualitative data were collected from intervention women participants, counsellors and midwives at baseline, midline and end of the study through 18 focus group discussions and 44 key informant interviews. Data analysis followed a thematic approach using framework analysis and a matrix-based system for organizing, reducing, and synthesizing data.
RESULTS


At baseline, FGD participants mentioned multiple sexual partners and lack of condom use as the main risks for pregnant and lactating women to acquire HIV. The main reasons for having multiple sexual partners were 1) the cultural practice not to have sex in the late pre-natal and early post-natal period; 2) increased sexual desire during pregnancy; 3) alcohol abuse; 4) poverty; and 5) conflict in couples. Consistent condom use at baseline was limited due to lack of knowledge and low acceptance of condom use in couples. The majority of intervention participants enrolled as couples felt enhanced counselling improved understanding, faithfulness, mutual support and appreciation within their couple. Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use. Participants stressed the importance of providing counselling services to all couples.
CONCLUSION


This study shows that enhanced individual and couple counselling linked to extended repeat HIV and STI testing and focusing on HIV prevention, couple communication, family planning and nutrition is a feasible and acceptable intervention that could enhance risk reduction programs among pregnant and lactating women.
TRIAL REGISTRATION


ClinicalTrials.gov registration number NCT01882998, date of registration 21st June 2013.",2020,"Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use.","[""women's partners"", '820 HIV-negative pregnant and lactating women aged 18-49\u2009years and 410 of their male partners to address the first pillar of the WHO Global Strategy for the Prevention of Mother-to-Child HIV transmission (PMTCT', 'PRIMAL Study participants were enrolled from two antenatal care clinics', 'pregnant and lactating women in the PRIMAL study, Uganda', 'pregnant and lactating women', 'Pregnant and Lactating', 'Ugandan Women']","['enhanced quarterly counseling on HIV risk reduction, couple communication, family planning and nutrition delivered by study counselors through up to 24\u2009months post-partum', 'enhanced counseling strategy linked to extended postpartum repeat HIV testing and enhanced counseling', 'Repeat] testing and counseling', 'repeat standard post-test counseling']","['risk reduction, couple communication, and emotional support', 'understanding, faithfulness, mutual support and appreciation within their couple']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C3714360', 'cui_str': 'Counseling strategy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",,0.0739136,"Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use.","[{'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Bannink Mbazzi', 'Affiliation': 'Medical Research Council / Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine Uganda Research Unit, P.O. Box 49, Entebbe, Uganda. femke.bannink@mrcuganda.org.'}, {'ForeName': 'Zikulah', 'Initials': 'Z', 'LastName': 'Namukwaya', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Amone', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Ojok', 'Affiliation': 'AVSI Foundation, Kampala, Uganda.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Etima', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Josaphat', 'Initials': 'J', 'LastName': 'Byamugisha', 'Affiliation': 'Department of Obstetrics and Gynecology, Makerere University School of Medicine, Kampala, Uganda.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Katabira', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jaco', 'Initials': 'J', 'LastName': 'Homsy', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC public health,['10.1186/s12889-020-08738-x']
73,25212745,"Intermittent montelukast in children aged 10 months to 5 years with wheeze (WAIT trial): a multicentre, randomised, placebo-controlled trial.","BACKGROUND


The effectiveness of intermittent montelukast for wheeze in young children is unclear. We aimed to assess whether intermittent montelukast is better than placebo for treatment of wheeze in this age group. Because copy numbers of the Sp1-binding motif in the arachidonate 5-lipoxygenase (ALOX5) gene promoter (either 5/5, 5/x, or x/x, where x does not equal 5) modifies response to montelukast in adults, we stratified by this genotype.
METHODS


We did this multicentre, parallel-group, randomised, placebo-controlled trial between Oct 1, 2010, and Dec 20, 2013, at 21 primary care sites and 41 secondary care sites in England and Scotland. Children aged 10 months to 5 years with two or more wheeze episodes were allocated to either a 5/5 or 5/x+x/x ALOX5 promoter genotype stratum, then randomly assigned (1:1) via a permuted block schedule (size ten), to receive intermittent montelukast or placebo given by parents at each wheeze episode over a 12 month period. Clinical investigators and parents were masked to treatment group and genotype strata. The primary outcome was number of unscheduled medical attendances for wheezing episodes. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01142505.
FINDINGS


We randomly assigned 1358 children to receive montelukast (n=669) or placebo (n=677). Consent was withdrawn for 12 (1%) children. Primary outcome data were available for 1308 (96%) children. There was no difference in unscheduled medical attendances for wheezing episodes between children in the montelukast and placebo groups (mean 2·0 [SD 2·6] vs 2·3 [2·7]; incidence rate ratio [IRR] 0·88, 95% CI: 0·77-1·01; p=0·06). Compared with placebo, unscheduled medical attendances for wheezing episodes were reduced in children given montelukast in the 5/5 stratum (2·0 [2·7] vs 2·4 [3·0]; IRR 0·80, 95% CI 0·68-0·95; p=0·01), but not in those in the 5/x+x/x stratum (2·0 [2·5] vs 2·0 [2·3]; 1·03, 0·83-1·29; p=0·79, pinteraction=0·08). We recorded one serious adverse event, which was a skin reaction in a child allocated to placebo.
INTERPRETATION


Our findings show no clear benefit of intermittent montelukast in young children with wheeze. However, the 5/5 ALOX5 promoter genotype might identify a montelukast-responsive subgroup.
FUNDING


Medical Research Council (UK) and National Institute for Health Research.",2014,There was no difference in unscheduled medical attendances for wheezing episodes between children in the montelukast and placebo groups (mean 2·0,"['young children', 'young children with wheeze', 'controlled trial between Oct 1, 2010, and Dec 20, 2013, at 21 primary care sites and 41 secondary care sites in England and Scotland', '1358 children to receive', 'children aged 10 months to 5 years with wheeze (WAIT trial', '2·5', 'Children aged 10 months to 5 years with two or more wheeze episodes']","['placebo', 'Intermittent montelukast', 'montelukast', 'intermittent montelukast or placebo', '5/x+x']","['unscheduled medical attendances for wheezing episodes', 'incidence rate ratio [IRR', 'unscheduled medical attendances', 'number of unscheduled medical attendances for wheezing episodes', 'wheezing episodes']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0298130', 'cui_str': 'montelukast'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0083017', 'cui_str': 'IRR'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",1358.0,0.772257,There was no difference in unscheduled medical attendances for wheezing episodes between children in the montelukast and placebo groups (mean 2·0,"[{'ForeName': 'Chinedu', 'Initials': 'C', 'LastName': 'Nwokoro', 'Affiliation': 'Asthma UK Centre for Applied Research, Queen Mary University of London, London, UK.'}, {'ForeName': 'Hitesh', 'Initials': 'H', 'LastName': 'Pandya', 'Affiliation': 'Department of Infection, Immunity and Inflammation, University of Leicester, Leicester, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Eldridge', 'Affiliation': 'Asthma UK Centre for Applied Research, Queen Mary University of London, London, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Griffiths', 'Affiliation': 'Asthma UK Centre for Applied Research, Queen Mary University of London, London, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Vulliamy', 'Affiliation': 'Asthma UK Centre for Applied Research, Queen Mary University of London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Asthma UK Centre for Applied Research, Queen Mary University of London, London, UK.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Sanak', 'Affiliation': 'Department of Medicine, Jagiellonian University Medical School, Krakow, Poland.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Holloway', 'Affiliation': 'Human Development and Health, University of Southampton, Southampton General Hospital, UK.'}, {'ForeName': 'Rossa', 'Initials': 'R', 'LastName': 'Brugha', 'Affiliation': 'Asthma UK Centre for Applied Research, Queen Mary University of London, London, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Koh', 'Affiliation': 'Asthma UK Centre for Applied Research, Queen Mary University of London, London, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Dickson', 'Affiliation': 'Asthma UK Centre for Applied Research, Queen Mary University of London, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Rutterford', 'Affiliation': 'Centre for Primary Care and Public Health, Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Grigg', 'Affiliation': 'Asthma UK Centre for Applied Research, Queen Mary University of London, London, UK. Electronic address: j.grigg@qmul.ac.uk.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(14)70186-9']
74,28630035,The Effects of Preoperative Volume Replacement in Diabetic Patients Undergoing Coronary Artery Bypass Grafting Surgery: Protocol for a Randomized Controlled Trial (VeRDiCT Trial).,"BACKGROUND


Diabetes mellitus is a major risk factor for prolonged hospital stays, renal failure, and mortality in patients having coronary artery bypass grafting (CABG). Complications pose a serious threat to patients and prolong intensive care and hospital stays. Low glomerular filtration rate (GFR) due to existing renal impairment or volume depletion may exacerbate acute renal impairment/failure in these patients. Preoperative volume replacement therapy (VRT) is reported to increase the GFR and we hypothesize that VRT will reduce renal impairment and related complications in diabetic patients.
OBJECTIVE


The objective of this study is to establish the efficacy of preoperative VRT in reducing postoperative complications in diabetic patients undergoing CABG surgery. Time to ""fit for discharge"", incidence of postoperative renal failure, cardiac injury, inflammation, and other health outcomes will be investigated.
METHODS


In this open parallel group randomized controlled trial, 170 diabetic patients undergoing elective or urgent CABG surgery received 1 mL/kg/hour of Hartmann's solution for 12 consecutive hours prior to surgery, versus routine care. The primary outcome was time until participants were ""fit for discharge"", which is defined as presence of: normal temperature, pulse, and respiration; normal oxygen saturation on air; normal bowel function; and physical mobility. Secondary outcomes included: incidence of renal failure; markers of renal function, inflammation, and cardiac damage; operative morbidity; intensive care stay; patient-assessed outcome, including the Coronary Revascularization Outcome Questionnaire; and use of hospital resources.
RESULTS


Recruitment started in July 2010. Enrolment for the study was completed in July 2014. Data analysis commenced in December 2016. Study results will be submitted for publication in the summer of 2017.
CONCLUSIONS


VRT is a relatively easy treatment to administer in patients undergoing surgical procedures who are at risk of renal failure. This experimental protocol will increase scientific and clinical knowledge of VRT in diabetic patients undergoing elective or urgent CABG surgery. Findings supporting the efficacy of this intervention could easily be implemented in the health care system.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN): 02159606; http://www.controlled-trials.com/ISRCTN02159606 (Archived by WebCite at http://www.webcitation.org/6rDkSSkkK).",2017,"CONCLUSIONS


VRT is a relatively easy treatment to administer in patients undergoing surgical procedures who are at risk of renal failure.","['diabetic patients undergoing CABG surgery', 'diabetic patients undergoing elective or urgent CABG surgery', 'patients having coronary artery bypass grafting (CABG', 'patients undergoing surgical procedures who are at risk of renal failure', 'Diabetes mellitus', '170 diabetic patients undergoing elective or urgent', 'Diabetic Patients Undergoing Coronary Artery Bypass Grafting Surgery', 'diabetic patients']","['VRT', 'Preoperative volume replacement therapy (VRT', ""CABG surgery received 1 mL/kg/hour of Hartmann's solution"", 'preoperative VRT', 'Preoperative Volume Replacement']","['postoperative complications', 'postoperative renal failure, cardiac injury, inflammation, and other health outcomes', 'time until participants were ""fit for discharge"", which is defined as presence of: normal temperature, pulse, and respiration; normal oxygen saturation on air; normal bowel function; and physical mobility', 'incidence of renal failure; markers of renal function, inflammation, and cardiac damage; operative morbidity; intensive care stay; patient-assessed outcome, including the Coronary Revascularization Outcome Questionnaire; and use of hospital resources', 'Low glomerular filtration rate (GFR']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0521302', 'cui_str': 'Body fluid replacement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0542211', 'cui_str': 'Postoperative renal failure (disorder)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0853673', 'cui_str': 'Oxygen saturation within reference range'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0085559'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",170.0,0.253522,"CONCLUSIONS


VRT is a relatively easy treatment to administer in patients undergoing surgical procedures who are at risk of renal failure.","[{'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Clout', 'Affiliation': 'Bristol Cardiovascular, Faculty of Health Science, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': 'Bristol Cardiovascular, Faculty of Health Science, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Bristol Cardiovascular, Faculty of Health Science, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Culliford', 'Affiliation': 'Bristol Cardiovascular, Faculty of Health Science, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Bristol Cardiovascular, Faculty of Health Science, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Angelini', 'Affiliation': 'Bristol Cardiovascular, Faculty of Health Science, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, India.'}, {'ForeName': 'Barnaby', 'Initials': 'B', 'LastName': 'Reeves', 'Affiliation': 'Bristol Cardiovascular, Faculty of Health Science, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hillier', 'Affiliation': 'Bristol Cardiovascular, Faculty of Health Science, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ashton', 'Affiliation': 'Bristol Cardiovascular, Faculty of Health Science, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Sarkar', 'Affiliation': 'Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, India.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Ascione', 'Affiliation': 'Bristol Cardiovascular, Faculty of Health Science, University of Bristol, Bristol, United Kingdom.'}]",JMIR research protocols,['10.2196/resprot.7386']
75,26482693,Effects of Changes in Regional Body Composition on Physical Function in Older Adults: A Pilot Randomized Controlled Trial.,"BACKGROUND/OBJECTIVE


Obesity exacerbates age-related physical disability; however, observational studies show that any weight loss in old age is associated with greater risk of mortality. Conversely, randomized controlled trials in older adults show that weight loss is beneficial. The discrepancy may be due to weight loss intention and differential changes to regional body composition. The purpose of this research was to evaluate the independent role of regional body composition remodeling in improving physical function.
DESIGN


Pilot Randomized Controlled Trial.
SETTING


Community based research center.
PARTICIPANTS


Thirty-six community dwelling, overweight to moderately obese (BMI 28.0-39.9 kg/m2) older adults (age 70.6±6.1 yrs).
INTERVENTION


Physical activity plus weight loss (PA+WL, n=21) or PA plus successful aging (SA) education. PA consisted primary of treadmill walking supplemented with lower extremity resistance and balance training. The WL program was based on the Diabetes Prevention Project and aimed at achieving a 7% weight loss by cutting calories, specifically those from fat.
MEASUREMENTS


At baseline, 6- and 12-months, body composition was measured using computerized tomography and dual x-ray absorptiometry. Abdominal visceral (VAT) and thigh intermuscular (IMAT) adipose tissue were quantified. Physical function was assessed using the short physical performance battery (SPPB).
RESULTS


Separate multivariable linear regression models with both groups combined demonstrated that decreases in IMAT and VAT were significantly associated with improvements in SPPB (P<0.05) independent of change in total fat mass. PA+WL improved SPPB scores from baseline (0.8±1.4, P<0.05), whereas PA+SA did not; however no intergroup difference was detected. Of note, these effects were mainly achieved during the intensive intervention phase.
CONCLUSION


Decreases in IMAT and VAT are important mechanisms underlying improved function following intentional weight loss plus physical activity.",2015,"PA+WL improved SPPB scores from baseline (0.8±1.4, P<0.05), whereas PA+SA did not; however no intergroup difference was detected.","['Community based research center', 'Obesity exacerbates age-related physical disability', 'Older Adults', 'Thirty-six community dwelling, overweight to moderately obese (BMI 28.0-39.9 kg/m2) older adults (age 70.6±6.1 yrs', 'older adults']","['treadmill walking supplemented with lower extremity resistance and balance training', 'Physical activity plus weight loss (PA+WL, n=21) or PA plus successful aging (SA) education']","['short physical performance battery (SPPB', 'IMAT and VAT', 'Physical function', 'total fat mass', 'SPPB scores', 'Abdominal visceral (VAT) and thigh intermuscular (IMAT) adipose tissue']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1444749', 'cui_str': 'Exacerbated (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}]",36.0,0.063599,"PA+WL improved SPPB scores from baseline (0.8±1.4, P<0.05), whereas PA+SA did not; however no intergroup difference was detected.","[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Santanasto', 'Affiliation': 'Nancy W. Glynn, PhD, 130 DeSoto Street, A531 Crabtree Hall Pittsburgh, PA 15261, 412.383.1309 (phone), 412.624.7397 (fax), glynnn@edc.pitt.edu.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Strotmeyer', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Boudreau', 'Affiliation': ''}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Goodpaster', 'Affiliation': ''}, {'ForeName': 'N W', 'Initials': 'NW', 'LastName': 'Glynn', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-015-0523-y']
76,31553469,Effect of Light Flashes vs Sham Therapy During Sleep With Adjunct Cognitive Behavioral Therapy on Sleep Quality Among Adolescents: A Randomized Clinical Trial.,"Importance


Owing to biological, behavioral, and societal factors, sleep duration in teenagers is often severely truncated, leading to pervasive sleep deprivation.
Objective


To determine whether a novel intervention, using both light exposure during sleep and cognitive behavioral therapy (CBT), would increase total sleep time in teenagers by enabling them to go to sleep earlier than usual.
Design, Setting, and Participants


This double-blind, placebo-controlled, randomized clinical trial, conducted between November 1, 2013, and May 31, 2016, among 102 adolescents enrolled full-time in grades 9 to 12, who expressed difficulty going to bed earlier and waking up early enough, was composed of 2 phases. In phase 1, participants were assigned to receive either 3 weeks of light or sham therapy and were asked to try to go to sleep earlier. In phase 2, participants received 4 brief CBT sessions in addition to a modified light or sham therapy. All analyses were performed on an intent-to-treat basis.
Interventions


Light therapy consisted of receiving a 3-millisecond light flash every 20 seconds during the final 3 hours of sleep (phase 1) or final 2 hours of sleep (phase 2). Sham therapy used an identical device, but delivered 1 minute of light pulses (appearing in 20-second intervals, for a total of 3 pulses) per hour during the final 3 hours of sleep (phase 1) or 2 hours of sleep (phase 2). Light therapy occurred every night during the 4-week intervention. Cognitive behavioral therapy consisted of four 50-minute in-person sessions once per week.
Main Outcomes and Measures


Primary outcome measures included diary-based sleep times, momentary ratings of evening sleepiness, and subjective measures of sleepiness and sleep quality.
Results


Among the 102 participants (54 female [52.9%]; mean [SD] age, 15.6 [1.1] years), 72 were enrolled in phase 1 and 30 were enrolled in phase 2. Mixed-effects models revealed that light therapy alone was inadequate in changing the timing of sleep. However, compared with sham therapy plus CBT alone, light therapy plus CBT significantly moved sleep onset a mean (SD) of 50.1 (27.5) minutes earlier and increased nightly total sleep time by a mean (SD) of 43.3 (35.0) minutes. Light therapy plus CBT also resulted in a 7-fold greater increase in bedtime compliance than that observed among participants receiving sham plus CBT (mean [SD], 2.21 [3.91] vs 0.29 [0.76]), as well as a mean 0.55-point increase in subjective evening sleepiness as compared with a mean 0.48-point decrease in participants receiving sham plus CBT as measured on a 7-point sleepiness scale.
Conclusions and Relevance


This study found that light exposure during sleep, in combination with a brief, motivation-focused CBT intervention, was able to consistently move bedtimes earlier and increase total sleep time in teenagers. This type of passive light intervention in teenagers may lead to novel therapeutic applications.
Trial Registration


ClinicalTrials.gov identifier: NCT01406691.",2019,"Light therapy plus CBT also resulted in a 7-fold greater increase in bedtime compliance than that observed among participants receiving sham plus CBT (mean [SD], 2.21 [3.91] vs 0.29 [0.76]), as well as a mean 0.55-point increase in subjective evening sleepiness as compared with a mean 0.48-point decrease in participants receiving sham plus CBT as measured on a 7-point sleepiness scale.
","['teenagers', 'Adolescents', 'November 1, 2013, and May 31, 2016, among 102 adolescents enrolled full-time in grades 9 to 12, who expressed difficulty going to bed earlier and waking up early enough, was composed of 2 phases', '102 participants (54 female [52.9%]; mean [SD] age, 15.6 [1.1] years), 72 were enrolled in phase 1 and 30 were enrolled in phase 2', 'teenagers by enabling them to go to sleep earlier than usual']","['4 brief CBT sessions in addition to a modified light or sham therapy', 'light therapy', 'Light therapy plus CBT', 'CBT intervention', 'light or sham therapy', 'light exposure during sleep and cognitive behavioral therapy (CBT', 'Adjunct Cognitive Behavioral Therapy', 'placebo', 'Cognitive behavioral therapy', 'Light Flashes vs Sham Therapy', 'Light therapy', 'passive light intervention']","['total sleep time', 'subjective evening sleepiness', 'Sleep Quality', 'diary-based sleep times, momentary ratings of evening sleepiness, and subjective measures of sleepiness and sleep quality', 'nightly total sleep time', '7-point sleepiness scale', 'bedtime compliance']","[{'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0587116', 'cui_str': 'During sleep (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085635', 'cui_str': 'Photopsia (disorder)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",102.0,0.0521975,"Light therapy plus CBT also resulted in a 7-fold greater increase in bedtime compliance than that observed among participants receiving sham plus CBT (mean [SD], 2.21 [3.91] vs 0.29 [0.76]), as well as a mean 0.55-point increase in subjective evening sleepiness as compared with a mean 0.48-point decrease in participants receiving sham plus CBT as measured on a 7-point sleepiness scale.
","[{'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Kaplan', 'Affiliation': 'Stanford Center for Sleep Sciences and Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Meital', 'Initials': 'M', 'LastName': 'Mashash', 'Affiliation': 'Stanford Center for Sleep Sciences and Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Rayma', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Stanford Center for Sleep Sciences and Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Batchelder', 'Affiliation': 'Palo Alto University, Palo Alto, California.'}, {'ForeName': 'Lolly', 'Initials': 'L', 'LastName': 'Starr-Glass', 'Affiliation': 'Palo Alto University, Palo Alto, California.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Zeitzer', 'Affiliation': 'Stanford Center for Sleep Sciences and Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.11944']
77,28738857,"Investigating interventions to increase uptake of HIV testing and linkage into care or prevention for male partners of pregnant women in antenatal clinics in Blantyre, Malawi: study protocol for a cluster randomised trial.","BACKGROUND


Despite large-scale efforts to diagnose people living with HIV, 54% remain undiagnosed in sub-Saharan Africa. The gap in knowledge of HIV status and uptake of follow-on services remains wide with much lower rates of HIV testing among men compared to women. Here, we design a study to investigate the effect on uptake of HIV testing and linkage into care or prevention of partner-delivered HIV self-testing alone or with an additional intervention among male partners of pregnant women.
METHODS


A phase II, adaptive, multi-arm, multi-stage cluster randomised trial, randomising antenatal clinic (ANC) days to six different trial arms. Pregnant women accessing ANC in urban Malawi for the first time will be recruited into either the standard of care (SOC) arm (invitation letter to the male partner offering HIV testing) or one of five intervention arms offering oral HIV self-test kits. Three of the five intervention arms will additionally offer the male partner a financial incentive (fixed or lottery amount) conditional on linkage after self-testing with one arm testing phone call reminders. Assuming that 25% of male partners link to care or prevention in the SOC arm, six clinic days, with a harmonic mean of 21 eligible participants, per arm will provide 80% power to detect a 0.15 absolute difference in the primary outcome. Cluster proportions will be analysed by a cluster summaries approach with adjustment for clustering and multiplicity.
DISCUSSION


This trial applies adaptive methods which are novel and efficient designs. The methodology and lessons learned here will be important as proof of concept of how to design and conduct similar studies in the future. Although small, this trial will potentially present good evidence on the type of effective interventions for improving linkage into ART or prevention. The trial results will also have important policy implications on how to implement HIVST targeting male partners of pregnant women who are accessing ANC for the first time while paying particular attention to safety concerns. Contamination may occur if women in the intervention arms share their self-test kits with women in the SOC arm.
TRIAL REGISTRATION


ISRCTN, ID: 18421340 . Registered on 31 March 2016.",2017,The gap in knowledge of HIV status and uptake of follow-on services remains wide with much lower rates of HIV testing among men compared to women.,"['male partners of pregnant women', 'Pregnant women accessing ANC in urban Malawi for the first time will be recruited into either the standard of care (SOC) arm (invitation letter to the male partner offering HIV testing', 'male partners of pregnant women in antenatal clinics in Blantyre, Malawi']","['financial incentive (fixed or lottery amount) conditional on linkage after self-testing with one arm testing phone call reminders', 'HIV testing and linkage into care or prevention of partner-delivered HIV self-testing alone or with an additional intervention', 'ID']",[],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]",[],,0.138054,The gap in knowledge of HIV status and uptake of follow-on services remains wide with much lower rates of HIV testing among men compared to women.,"[{'ForeName': 'Augustine T', 'Initials': 'AT', 'LastName': 'Choko', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, PO Box 30096, Chichiri, Blantyre 3, Malawi. augutc@gmail.com.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fielding', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Warwick Medical School, Coventry, UK.'}, {'ForeName': 'Hendramoorthy', 'Initials': 'H', 'LastName': 'Maheswaran', 'Affiliation': 'Warwick Medical School, Coventry, UK.'}, {'ForeName': 'Aurelia', 'Initials': 'A', 'LastName': 'Lepine', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Desmond', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, PO Box 30096, Chichiri, Blantyre 3, Malawi.'}, {'ForeName': 'Moses K', 'Initials': 'MK', 'LastName': 'Kumwenda', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, PO Box 30096, Chichiri, Blantyre 3, Malawi.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Corbett', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, PO Box 30096, Chichiri, Blantyre 3, Malawi.'}]",Trials,['10.1186/s13063-017-2093-2']
78,28694204,The Mind Body-Wellness in Supportive Housing (Mi-WiSH) study: Design and rationale of a cluster randomized controlled trial of Tai Chi in senior housing.,"Supporting the health of growing numbers of frail older adults living in subsidized housing requires interventions that can combat frailty, improve residents' functional abilities, and reduce their health care costs. Tai Chi is an increasingly popular multimodal mind-body exercise that incorporates physical, cognitive, social, and meditative components in the same activity and offers a promising intervention for ameliorating many of the conditions that lead to poor health and excessive health care utilization. The Mind Body-Wellness in Supportive Housing (Mi-WiSH) study is an ongoing two-arm cluster randomized, attention-controlled trial designed to examine the impact of Tai Chi on functional indicators of health and health care utilization. We are enrolling participants from 16 urban subsidized housing facilities (n=320 participants), conducting the Tai Chi intervention or education classes and social calls (attention control) in consenting subjects within the facilities for one year, and assessing these subjects at baseline, 6months, and 1year. Physical function (quantified by the Short Physical Performance Battery), and health care utilization (emergency visits, hospitalizations, skilled nursing and nursing home admissions), assessed at 12months are co-primary outcomes. Our discussion highlights our strategy to balance pragmatic and explanatory features into the study design, describes efforts to enhance site recruitment and participant adherence, and summarizes our broader goal of post study dissemination if effectiveness and cost-effectiveness are demonstrated, by preparing training and protocol manuals for use in housing facilities across the U.S.",2017,"Physical function (quantified by the Short Physical Performance Battery), and health care utilization (emergency visits, hospitalizations, skilled nursing and nursing home admissions), assessed at 12months are co-primary outcomes.","['enrolling participants from 16 urban subsidized housing facilities (n=320 participants', 'senior housing', 'frail older adults']","['Tai Chi intervention or education classes and social calls (attention control', 'Tai Chi']","['Physical function (quantified by the Short Physical Performance Battery), and health care utilization (emergency visits, hospitalizations, skilled nursing and nursing home admissions']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]",320.0,0.0561436,"Physical function (quantified by the Short Physical Performance Battery), and health care utilization (emergency visits, hospitalizations, skilled nursing and nursing home admissions), assessed at 12months are co-primary outcomes.","[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, United States. Electronic address: pwayne@partners.org.""}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Gagnon', 'Affiliation': 'Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School, Boston, MA, United States. Electronic address: gagnon@hsl.harvard.edu.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States. Electronic address: emacklin@mgh.harvard.edu.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Travison', 'Affiliation': 'Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School, Boston, MA, United States. Electronic address: TGT@hsl.harvard.edu.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School, Boston, MA, United States. Electronic address: BradManor@hsl.harvard.edu.'}, {'ForeName': 'Margie', 'Initials': 'M', 'LastName': 'Lachman', 'Affiliation': 'Department of Psychology, Brandeis University, Waltham, MA, United States. Electronic address: lachman@brandeis.edu.'}, {'ForeName': 'Cindy P', 'Initials': 'CP', 'LastName': 'Thomas', 'Affiliation': 'The Heller School for Social Policy and Management, Brandeis University, Waltham, MA, United States. Electronic address: cthomas@brandeis.edu.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School, Boston, MA, United States. Electronic address: Lipsitz@hsl.harvard.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2017.07.005']
79,28444178,Shortening cardioplegic arrest time in patients undergoing combined coronary and valve surgery: results from a multicentre randomized controlled trial: the SCAT trial.,"OBJECTIVES


Combined coronary artery bypass grafting and valve surgery requires a prolonged period of cardioplegic arrest (CA) predisposing to myocardial injury and postoperative cardiac-specific complications. The aim of this trial was to reduce the CA time in patients undergoing combined coronary artery bypass grafting and valve surgery and assess if this was associated with less myocardial injury and related complications.
METHODS


Participants were randomized to (i) coronary artery bypass grafting performed on the beating heart with cardiopulmonary bypass support followed by CA for the valve procedure (hybrid) or (ii) both procedures under CA (conventional). To assess complications related to myocardial injury, we used the composite of death, myocardial infarction, arrhythmia, need for pacing or inotropes for >12 h. To assess myocardial injury, we used serial plasma troponin T and markers of metabolic stress in myocardial biopsies.
RESULTS


Hundred and sixty patients (80 hybrid and 80 conventional) were randomized. Mean age was 66.5 years and 74% were male. Valve procedures included aortic (61.8%) and mitral (33.1%) alone or in combination (5.1%). CA time was 16% lower in the hybrid group [median 98 vs 89 min, geometric mean ratio (GMR) 0.84, 95% confidence interval (CI) 0.77-0.93, P  = 0.0004]. Complications related to myocardial injury occurred in 131/160 patients (64/80 conventional, 67/80 hybrid), odds ratio 1.24, 95% CI 0.54-2.86, P  = 0.61. Release of troponin T was similar between groups (GMR 1.04, 95% CI 0.87-1.24, P  = 0.68). Adenosine monophosphate was 28% lower in the hybrid group (GMR 0.72, 95% CI 0.51-1.02, P  = 0.056).
CONCLUSIONS


The hybrid procedure reduced the CA time but myocardial injury outcomes were not superior to conventional approach.
TRIAL REGISTRATION


ISRCTN65770930.",2017,Adenosine monophosphate was 28% lower in the hybrid group,"['patients undergoing', 'Mean age was 66.5 years and 74% were male', 'patients undergoing combined coronary and valve surgery', 'Participants', 'Hundred and sixty patients (80 hybrid and 80 conventional']","['Adenosine monophosphate', 'coronary artery bypass grafting and valve surgery', 'combined coronary artery bypass grafting and valve surgery', 'coronary artery bypass grafting performed on the beating heart with cardiopulmonary bypass support followed by CA for the valve procedure (hybrid) or (ii) both procedures under CA (conventional']","['CA time but myocardial injury outcomes', 'composite of death, myocardial infarction, arrhythmia, need for pacing or inotropes', 'CA time', 'Release of troponin T', 'myocardial injury']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0001465', 'cui_str': 'Adenosine Monophosphate'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}]",,0.290535,Adenosine monophosphate was 28% lower in the hybrid group,"[{'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Radek', 'Initials': 'R', 'LastName': 'Capoun', 'Affiliation': 'Bristol Heart Institute, School of Clinical Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Scott', 'Affiliation': 'Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'SAL Hospital and Medical Institute, Ahmedabad, India.'}, {'ForeName': 'Gianni D', 'Initials': 'GD', 'LastName': 'Angelini', 'Affiliation': 'Bristol Heart Institute, School of Clinical Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Rabindranath Tagore International Institute of Cardiac Sciences (RTIICS), Kolkata, India.'}, {'ForeName': 'M-Saadeh', 'Initials': 'MS', 'LastName': 'Suleiman', 'Affiliation': 'Bristol Heart Institute, School of Clinical Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Sarkar', 'Affiliation': 'Rabindranath Tagore International Institute of Cardiac Sciences (RTIICS), Kolkata, India.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Ascione', 'Affiliation': 'Bristol Heart Institute, School of Clinical Sciences, University of Bristol, Bristol, UK.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezx087']
80,26106316,"Tai Chi Training may Reduce Dual Task Gait Variability, a Potential Mediator of Fall Risk, in Healthy Older Adults: Cross-Sectional and Randomized Trial Studies.","BACKGROUND


Tai Chi (TC) exercise improves balance and reduces falls in older, health-impaired adults. TC's impact on dual task (DT) gait parameters predictive of falls, especially in healthy active older adults, however, is unknown.
PURPOSE


To compare differences in usual and DT gait between long-term TC-expert practitioners and age-/gender-matched TC-naïve adults, and to determine the effects of short-term TC training on gait in healthy, non-sedentary older adults.
METHODS


A cross-sectional study compared gait in healthy TC-naïve and TC-expert (24.5 ± 12 years experience) older adults. TC-naïve adults then completed a 6-month, two-arm, wait-list randomized clinical trial of TC training. Gait speed and stride time variability (Coefficient of Variation %) were assessed during 90 s trials of undisturbed and cognitive DT (serial subtractions) conditions.
RESULTS


During DT, gait speed decreased (p < 0.003) and stride time variability increased (p < 0.004) in all groups. Cross-sectional comparisons indicated that stride time variability was lower in the TC-expert vs. TC-naïve group, significantly so during DT (2.11 vs. 2.55%; p = 0.027); by contrast, gait speed during both undisturbed and DT conditions did not differ between groups. Longitudinal analyses of TC-naïve adults randomized to 6 months of TC training or usual care identified improvement in DT gait speed in both groups. A small improvement in DT stride time variability (effect size = 0.2) was estimated with TC training, but no significant differences between groups were observed. Potentially important improvements after TC training could not be excluded in this small study.
CONCLUSION


In healthy active older adults, positive effects of short- and long-term TC were observed only under cognitively challenging DT conditions and only for stride time variability. DT stride time variability offers a potentially sensitive metric for monitoring TC's impact on fall risk with healthy older adults.",2015,"Cross-sectional comparisons indicated that stride time variability was lower in the TC-expert vs. TC-naïve group, significantly so during DT (2.11 vs. 2.55%; p = 0.027); by contrast, gait speed during both undisturbed and DT conditions did not differ between groups.","['gait in healthy, non-sedentary older adults', 'TC-naïve adults', 'Healthy Older Adults', 'healthy active older adults', 'older, health-impaired adults', 'healthy older adults', 'A cross-sectional study compared gait in healthy TC-naïve and TC-expert (24.5\u2009±\u200912\u2009years experience) older adults']","['TC training', 'short-term TC training', 'Tai Chi (TC) exercise', 'Tai Chi Training']","['Dual Task Gait Variability', 'stride time variability', 'DT stride time variability', 'dual task (DT) gait parameters predictive of falls', 'DT gait speed', 'gait speed', 'usual and DT gait', 'Gait speed and stride time variability']","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}]",,0.0231762,"Cross-sectional comparisons indicated that stride time variability was lower in the TC-expert vs. TC-naïve group, significantly so during DT (2.11 vs. 2.55%; p = 0.027); by contrast, gait speed during both undisturbed and DT conditions did not differ between groups.","[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Division of Preventive Medicine, Osher Center for Integrative Medicine, Brigham and Women's Hospital , Boston, MA , USA ; Harvard Medical School , Boston, MA , USA.""}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': 'Department of Neurology, Center for the Study of Movement, Cognition, and Mobility, Tel Aviv Sourasky Medical Center, Tel Aviv University , Tel Aviv , Israel.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lough', 'Affiliation': 'Institute for Aging Research, Hebrew Senior Life , Boston, MA , USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Gow', 'Affiliation': ""Division of Preventive Medicine, Osher Center for Integrative Medicine, Brigham and Women's Hospital , Boston, MA , USA ; Harvard Medical School , Boston, MA , USA.""}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Lipsitz', 'Affiliation': 'Institute for Aging Research, Hebrew Senior Life , Boston, MA , USA.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Novak', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center , Boston, MA , USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Harvard Medical School , Boston, MA , USA ; Biostatistics Center, Massachusetts General Hospital , Boston, MA , USA.'}, {'ForeName': 'Chung-Kang', 'Initials': 'CK', 'LastName': 'Peng', 'Affiliation': 'Division of Interdisciplinary Medicine and Biotechnology, Beth Israel Deaconess Medical Center , Boston, MA , USA ; Center for Dynamical Biomarkers and Translational Medicine, National Central University , Chungli , Taiwan.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'Institute for Aging Research, Hebrew Senior Life , Boston, MA , USA.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2015.00332']
81,24857519,Melatonin and dopamine as biomarkers to optimize treatment in phenylketonuria: effects of tryptophan and tyrosine supplementation.,"OBJECTIVE


To determine whether additional supplementation of tryptophan (Trp) and tyrosine (Tyr) improve serotonin and dopamine metabolism in individuals with phenylketonuria treated with large neutral amino acid (LNAA) tablets.
STUDY DESIGN


Ten adult individuals with phenylketonuria participated in a randomized, double-blind, placebo-controlled cross-over study consisting of three 3-week phases: washout, treatment with LNAA tablets plus supplementation with either Trp and Tyr tablets or placebo, and LNAA tablets plus the alternate supplementation. An overnight protocol to measure blood melatonin, a serotonin metabolite in the pinealocytes, and urine 6-sulfatoxymelatonin and dopamine in first-void urine specimens was conducted after each phase.
RESULTS


Serum melatonin and urine 6-sulfatoxymelatonin and dopamine levels were increased in the LNAA phase (LNAA plus placebo) compared with the washout phase. Serum melatonin and urine 6-sulfatoxymelatonin were not increased in the active phase (LNAA plus Trp + Tyr) compared with the LNAA phase, although plasma Trp:LNAA was increased compared with the LNAA phase. Among 7 subjects with a plasma Trp/LNAA >0.03, a negative correlation between urine 6-sulfatoxymelatonin and plasma phenylalanine levels was observed (r = -0.072). Urine dopamine levels and plasma Tyr:LNAA were increased in the active phase compared with the LNAA phase.
CONCLUSION


Melatonin levels were not increased with the higher dose of Trp supplementation, but dopamine levels were increased with the higher dose of Tyr supplementation. Serotonin synthesis appears to be suppressed by high phenylalanine levels at the Trp hydroxylase level.",2014,"Serum melatonin and urine 6-sulfatoxymelatonin were not increased in the active phase (LNAA plus Trp + Tyr) compared with the LNAA phase, although plasma Trp:LNAA was increased compared with the LNAA phase.","['Ten adult individuals with phenylketonuria participated', 'individuals with phenylketonuria treated with large neutral amino acid (LNAA) tablets', 'phenylketonuria']","['placebo', 'LNAA phase (LNAA plus placebo', 'LNAA tablets plus supplementation with either Trp and Tyr tablets or placebo, and LNAA tablets plus the alternate supplementation', 'tryptophan (Trp) and tyrosine (Tyr', 'Melatonin and dopamine']","['Serum melatonin and urine 6-sulfatoxymelatonin and dopamine levels', 'Serum melatonin and urine 6-sulfatoxymelatonin', 'dopamine levels', 'urine 6-sulfatoxymelatonin and plasma phenylalanine levels', 'Urine dopamine levels and plasma Tyr', 'Melatonin levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0751434', 'cui_str': 'Phenylalanine Hydroxylase Deficiency'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0301715', 'cui_str': 'Amino Acids, Neutral'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0147288', 'cui_str': 'Tyr(TMA)'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0042037'}, {'cui': 'C0049713', 'cui_str': '6-hydroxymelatoninsulfate'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1278172', 'cui_str': 'Plasma phenylalanine measurement'}, {'cui': 'C0428373', 'cui_str': 'Urine dopamine level'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0147288', 'cui_str': 'Tyr(TMA)'}]",10.0,0.134312,"Serum melatonin and urine 6-sulfatoxymelatonin were not increased in the active phase (LNAA plus Trp + Tyr) compared with the LNAA phase, although plasma Trp:LNAA was increased compared with the LNAA phase.","[{'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Yano', 'Affiliation': 'Genetics Division, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Moseley', 'Affiliation': 'Genetics Division, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Azen', 'Affiliation': 'Clinical and Translational Science Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2014.03.061']
82,24560036,"School-located vaccination of adolescents with insurance billing: cost, reimbursement, and vaccination outcomes.","PURPOSE


To assess, in a school-located adolescent vaccination program that billed health insurance, the program costs, the proportion of costs reimbursed, and the likelihood of vaccination.
METHODS


During the 2010-2011 school year, vaccination clinics were held for sixth- to eighth-grade students at seven Denver public schools. Vaccine administration and purchase costs were compared with reimbursement by insurers. Multivariate analyses were used to compare the likelihood of vaccination among students in intervention schools with students in control schools who did not participate in the program, with analyses stratified by grade (sixth grade vs. seventh-eighth grades).
RESULTS


Fifteen percent (466 of 3,144) of students attending intervention schools were vaccinated at school-located vaccination clinics. Among students vaccinated at school, 41% were uninsured, 37% publicly insured, and 22% privately insured. Estimated vaccine administration costs were $23.98 per vaccine dose. Seventy-eight percent of vaccine purchase costs and 14% of vaccine administration costs were reimbursed by insurers; 41% of total program costs were reimbursed. Sixth-grade students in intervention schools were more likely than those in control schools to receive tetanus-diphtheria-acellular pertussis (risk ratio [RR], 1.30; 95% confidence interval [CI], 1.08, 1.57), meningococcal conjugate (RR, 1.42; CI, 1.18, 1.70), and human papillomavirus (for females only, RR, 1.69; CI, 1.21, 2.36) vaccines during the 2010-2011 school year, with similar results for seventh- to eighth-grade students.
CONCLUSIONS


Although school-located adolescent vaccination with billing appears feasible and likely to improve vaccination rates, improvements in insurance coverage and reimbursement rates may be needed for the long-term financial sustainability of such programs.",2014,"Sixth-grade students in intervention schools were more likely than those in control schools to receive tetanus-diphtheria-acellular pertussis (risk ratio [RR], 1.30; 95% confidence interval [CI], 1.08, 1.57), meningococcal conjugate (RR, 1.42; CI, 1.18, 1.70), and human papillomavirus (for females only, RR, 1.69; CI, 1.21, 2.36) vaccines during the 2010-2011 school year, with similar results for seventh- to eighth-grade students.
","['students vaccinated at school, 41% were uninsured, 37% publicly insured, and 22% privately insured', 'Fifteen percent (466 of 3,144) of students attending intervention schools were vaccinated at school-located vaccination clinics', 'During the 2010-2011 school year, vaccination clinics were held for sixth- to eighth-grade students at seven Denver public schools']",['Vaccine'],[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0087134', 'cui_str': 'Uninsured'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0338051', 'cui_str': 'Vaccination clinic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1553387', 'cui_str': 'Hold'}, {'cui': 'C0205440', 'cui_str': 'Sixth (qualifier value)'}, {'cui': 'C0205442', 'cui_str': 'Eighth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}]",[],,0.0286859,"Sixth-grade students in intervention schools were more likely than those in control schools to receive tetanus-diphtheria-acellular pertussis (risk ratio [RR], 1.30; 95% confidence interval [CI], 1.08, 1.57), meningococcal conjugate (RR, 1.42; CI, 1.18, 1.70), and human papillomavirus (for females only, RR, 1.69; CI, 1.21, 2.36) vaccines during the 2010-2011 school year, with similar results for seventh- to eighth-grade students.
","[{'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Daley', 'Affiliation': 'Department of Pediatrics, University of Colorado Denver, Aurora, Colorado; Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado. Electronic address: matthew.f.daley@kp.org.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kempe', 'Affiliation': ""Department of Pediatrics, University of Colorado Denver, Aurora, Colorado; Children's Outcomes Research Program, Children's Hospital Colorado, Aurora, Colorado; Colorado Health Outcomes Program, University of Colorado Denver, Aurora, Colorado.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pyrzanowski', 'Affiliation': ""Children's Outcomes Research Program, Children's Hospital Colorado, Aurora, Colorado.""}, {'ForeName': 'Tara M', 'Initials': 'TM', 'LastName': 'Vogt', 'Affiliation': 'National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'L Miriam', 'Initials': 'LM', 'LastName': 'Dickinson', 'Affiliation': ""Children's Outcomes Research Program, Children's Hospital Colorado, Aurora, Colorado; Department of Family Medicine, University of Colorado Denver, Aurora, Colorado.""}, {'ForeName': 'Deidre', 'Initials': 'D', 'LastName': 'Kile', 'Affiliation': 'Colorado Health Outcomes Program, University of Colorado Denver, Aurora, Colorado.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'Health Systems, Management, and Policy, Colorado School of Public Health, Aurora, Colorado.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Rinehart', 'Affiliation': 'Health Services Research, Denver Health, Denver, Colorado.'}, {'ForeName': 'Judith C', 'Initials': 'JC', 'LastName': 'Shlay', 'Affiliation': 'Department of Family Medicine, University of Colorado Denver, Aurora, Colorado; Denver Public Health, Denver, Colorado.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2013.12.011']
83,25450133,A shoe insole delivering subsensory vibratory noise improves balance and gait in healthy elderly people.,"OBJECTIVES


To test whether subsensory vibratory noise applied to the sole of the foot using a novel piezoelectric vibratory insole can significantly improve sensation, enhance balance, and reduce gait variability in elderly people, as well as to determine the optimal level of vibratory noise and whether the therapeutic effect would endure and the user's sensory threshold would remain constant during the course of a day.
DESIGN


A randomized, single-blind, crossover study of 3 subsensory noise stimulation levels on 3 days.
SETTING


Balance and gait laboratory.
PARTICIPANTS


Healthy community-dwelling elderly volunteers (N=12; age, 65-90y) who could feel the maximum insole vibration.
INTERVENTIONS


A urethane foam insole with the piezoelectric actuators delivering subsensory vibratory noise stimulation to the soles of the feet.
MAIN OUTCOME MEASURES


Balance, gait, and timed Up and Go (TUG) test.
RESULTS


The vibratory insoles significantly improved performance on the TUG test, reduced the area of postural sway, and reduced the temporal variability of walking at both 70% and 85% of the sensory threshold and during the course of a day. Vibratory sensation thresholds remained relatively stable within and across study days.
CONCLUSIONS


This study provides proof of concept that the application of the principle of stochastic resonance to the foot sole sensory system using a new low-voltage piezoelectric technology can improve measures of balance and gait that are associated with falls. Effective vibratory noise amplitudes range from 70% to 85% of the sensory threshold and can be set once daily.",2015,"The vibratory insoles significantly improved performance on the TUG test, reduced the area of postural sway, and reduced the temporal variability of walking at both 70% and 85% of the sensory threshold and during the course of a day.","['elderly people', 'Healthy community-dwelling elderly volunteers (N=12; age, 65-90y) who could feel the maximum insole vibration', 'healthy elderly people']","['subsensory vibratory noise', 'piezoelectric actuators delivering subsensory vibratory noise stimulation']","['Balance, gait, and timed Up and Go (TUG) test', 'Vibratory sensation thresholds', 'temporal variability of walking', 'area of postural sway']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}]","[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C1706706', 'cui_str': 'Actuator (physical object)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0234198', 'cui_str': 'Vibratory sense, function'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}]",,0.0218938,"The vibratory insoles significantly improved performance on the TUG test, reduced the area of postural sway, and reduced the temporal variability of walking at both 70% and 85% of the sensory threshold and during the course of a day.","[{'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Hebrew SeniorLife, Institute for Aging Research, Boston, MA; Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA. Electronic address: lipsitz@hsl.harvard.edu.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lough', 'Affiliation': 'Hebrew SeniorLife, Institute for Aging Research, Boston, MA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Niemi', 'Affiliation': 'Harvard Medical School, Boston, MA; Wyss Institute for Biologically Inspired Engineering at Harvard University, Boston, MA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Travison', 'Affiliation': 'Hebrew SeniorLife, Institute for Aging Research, Boston, MA; Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Howlett', 'Affiliation': 'Merck Sharp and Dohme Consumer Care, Inc, Memphis, TN.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'Hebrew SeniorLife, Institute for Aging Research, Boston, MA; Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2014.10.004']
84,25079465,Effects of synbiotic food consumption on glycemic status and serum hs-CRP in pregnant women: a randomized controlled clinical trial.,"OBJECTIVE


The aim of this study was to determine the effects of synbiotic food consumption on glycemic status and serum high sensitivity C-reactive protein (hs-CRP) levels of Iranian pregnant women.
DESIGN


This randomized placebo-controlled clinical trial was performed among 52 pregnant women, primigravida, aged 18-35 year old, in their third trimester. After a 2-wk run-in period, subjects were randomly assigned to consume either a synbiotic (n=26) or control food (n=26) for 9 weeks. The synbiotic food consisted of a probiotic Lactobacillus sporogenes (1×107 CFU), 0.04 g inulin as prebiotic with 0.38 g isomalt, 0.36 g sorbitol and 0.05 g stevia as sweetener per 1 g. Control food (the same substance without probiotic bacteria and inulin) was packed in identical 9-gram packages. Patients were asked to consume the synbiotic and control foods two times a day. Fasting blood samples were taken at baseline and after a 9-wk intervention for quantification of related factors.
RESULTS


Consumption of a synbiotic food did not show any significant change regarding the impact of insulin actions in the synbiotic group; nonetheless, compared to the control food, it resulted in a significant decrease in serum insulin levels (-0.26 vs. 6.34 µIU/mL, P=0.014) and HOMA-IR (-0.13 vs. 1.13, P=0.033), a significant difference in HOMA-B (5.30 vs. 34.22, P=0.040) and a significant rise in QUICKI score (0.002 vs. -0.02, P=0.022).
CONCLUSIONS


Consumption of a synbiotic food for 9 weeks by pregnant women had beneficial effects on insulin actions compared to the control food, but did not affect FPG and serum hs-CRP concentrations.",2014,"RESULTS


Consumption of a synbiotic food did not show any significant change regarding the impact of insulin actions in the synbiotic group; nonetheless, compared to the control food, it resulted in a significant decrease in serum insulin levels (-0.26 vs. 6.34 µIU/mL, P=0.014) and HOMA-IR (-0.13 vs. 1.13, P=0.033), a significant difference in HOMA-B (5.30 vs. 34.22, P=0.040) and a significant rise in QUICKI score (0.002 vs. -0.02, P=0.022).
","['pregnant women', '52 pregnant women, primigravida, aged 18-35 year old, in their third trimester', 'Iranian pregnant women']","['synbiotic (n=26) or control food', 'synbiotic food consumption', 'placebo', 'probiotic Lactobacillus sporogenes']","['serum insulin levels', 'insulin actions', 'QUICKI score', 'FPG and serum hs-CRP concentrations', 'Fasting blood samples', 'glycemic status and serum hs-CRP', 'HOMA-IR', 'HOMA-B']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0860096', 'cui_str': 'Primigravida (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0314879', 'cui_str': 'Lactobacillus sporogenes'}]","[{'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",52.0,0.207678,"RESULTS


Consumption of a synbiotic food did not show any significant change regarding the impact of insulin actions in the synbiotic group; nonetheless, compared to the control food, it resulted in a significant decrease in serum insulin levels (-0.26 vs. 6.34 µIU/mL, P=0.014) and HOMA-IR (-0.13 vs. 1.13, P=0.033), a significant difference in HOMA-B (5.30 vs. 34.22, P=0.040) and a significant rise in QUICKI score (0.002 vs. -0.02, P=0.022).
","[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Taghizadeh', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}, {'ForeName': 'Zatolla', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran.'}]","Hormones (Athens, Greece)",['10.14310/horm.2002.1489']
85,25213687,"Aldosterone, cognitive function, and cerebral hemodynamics in hypertension and antihypertensive therapy.","BACKGROUND


Animal studies suggest that the renin-angiotensin-aldosterone system is involved in neurocognitive function and the response to antihypertensive therapy. We investigated the impact of circulating aldosterone and renin activity on cognition and cerebral hemodynamics at baseline and after antihypertensive therapy for 1 year.
METHODS


Participants were older adults (n = 47; mean age = 71 years) enrolled in a clinical trial. Routine antihypertensive medications were replaced with the study regimen to achieve a blood pressure <140/90 mm Hg. Executive function, memory, cerebral hemodynamics (blood flow velocity), CO2 vasoreactivity (measured using transcranial Doppler ultrasonography), plasma renin activity, and aldosterone were measured at baseline and at 6 and 12 months after the initiation of treatment.
RESULTS


At baseline, higher levels of circulating aldosterone were associated with lower blood flow velocity (β = -0.02; P = 0.03), lower CO2 vasoreactivity (β = -0.11; P = 0.007), and decreased autoregulation abilities (β = -0.09; P = 0.01). Those with higher levels of aldosterone at baseline demonstrated the greatest improvement in executive function (P = 0.014 for the aldosterone effect) and in CO2 vasoreactivity (P = 0.026 for the aldosterone effect) after 12 months of lowering blood pressure (<140/90 mm Hg). Plasma renin activity was not associated with any of the measures.
CONCLUSIONS


Higher levels of aldosterone may be associated with decreased cerebrovascular function in hypertension. Those with higher aldosterone levels may benefit the most from lowering blood pressure. The role of aldosterone in brain health warrants further investigation in a larger trial.",2015,Those with higher levels of aldosterone at baseline demonstrated the greatest improvement in executive function (P = 0.014 for the aldosterone effect) and in CO2 vasoreactivity (P = 0.026 for the aldosterone effect) after 12 months of lowering blood pressure (<140/90 mm Hg).,['Participants were older adults (n = 47; mean age = 71 years) enrolled in a clinical trial'],"['aldosterone', 'circulating aldosterone and renin activity']","['executive function', 'blood flow velocity', 'autoregulation abilities', 'CO2 vasoreactivity', 'blood pressure', 'cerebrovascular function', 'levels of circulating aldosterone', 'Executive function, memory, cerebral hemodynamics (blood flow velocity), CO2 vasoreactivity (measured using transcranial Doppler ultrasonography), plasma renin activity, and aldosterone', 'Plasma renin activity', 'lower CO2 vasoreactivity', 'Aldosterone, cognitive function, and cerebral hemodynamics', 'cognition and cerebral hemodynamics']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.121288,Those with higher levels of aldosterone at baseline demonstrated the greatest improvement in executive function (P = 0.014 for the aldosterone effect) and in CO2 vasoreactivity (P = 0.026 for the aldosterone effect) after 12 months of lowering blood pressure (<140/90 mm Hg).,"[{'ForeName': 'Ihab', 'Initials': 'I', 'LastName': 'Hajjar', 'Affiliation': 'Division of Geriatrics and General Internal Medicine, Department of Medicine, Emory University, Atlanta, Georgia, USA; ihajjar@emory.edu.'}, {'ForeName': 'Meaghan', 'Initials': 'M', 'LastName': 'Hart', 'Affiliation': 'Institute for Aging Research, Hebrew SeniorLife, Boston, Massachusetts, USA;'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, California, USA;'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Harvard Medical School, Institute for Aging Research, and Hebrew SeniorLife, Division of Gerontology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}]",American journal of hypertension,['10.1093/ajh/hpu161']
86,22149540,Bidimensional techniques for stronger anterior torque control in extraction cases: a combined clinical and typodont study.,"OBJECTIVE


To investigate the capacity of bidimensional techniques for torque control of anterior teeth in extraction cases.
MATERIALS AND METHODS


Two different bidimensional techniques were distinguished by nomenclature as bidimensional-slot (bDS) and bidimensional-wire (bDW), respectively. (1) In the clinical study, patients were randomly assigned to three groups (ie, bDS [n  =  27], bDW [n  =  24], and control [n  =  25] groups). The major inclusion criterion was mild crowding in the upper arch, with the two upper first premolars (teeth 14 and 24) to be extracted. After space closure through standardized treatment, the torque of the upper central incisors (∠TQ _U1) was calculated using the angle formed by the base of the U1 bracket and the working archwire on cephalograms. (2) In the typodont study, a standardized setup of the upper dentition with teeth 14 and 24 extracted was established. The spaces were closed through water bath followed by elastics, using the bDW or the conventional (control) technique, respectively. In six replicate experiments, after space closure, the ∠TQ _U1 was measured on the standardized lateral photographs.
RESULTS


(1) In the clinical study, after space closure, the ∠TQ_U1 was 9.4° ± 3.4° (bDS), 8.3° ± 3.3° (bDW), and 5.8° ± 2.9° (control), respectively. The ∠TQ_U1 of bDS and bDW were both significantly (P < .05) larger than that of the control, but no statistical difference was found between them. (2) In the typodont study, after space closure, the ∠TQ_U1 of bDW (8.5° ± 0.9°) was significantly (P < .01) larger than that of the control (4.9° ± 1.0°).
CONCLUSION


The bDS and the bDW techniques may help enhance anterior torque control in extraction cases.",2012,"The ∠TQ_U1 of bDS and bDW were both significantly (P < .05) larger than that of the control, but no statistical difference was found between them.",[],['Bidimensional techniques'],"['∠TQ_U1 of bDS and bDW', '∠TQ_U1 of bDW']",[],"[{'cui': 'C0025664', 'cui_str': 'techniques'}]",[],,0.0170134,"The ∠TQ_U1 of bDS and bDW were both significantly (P < .05) larger than that of the control, but no statistical difference was found between them.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Orthodontics, State Key Laboratory of Oral Diseases, West China Stomatology Hospital, Sichuan University, Chengdu, PR China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Zhenrui', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Zhihe', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/082811-550.1']
87,22348399,Evaluating the effectiveness of GP endorsement on increasing participation in the NHS Bowel Cancer Screening Programme in England: study protocol for a randomized controlled trial.,"BACKGROUND


The success and cost-effectiveness of bowel cancer screening depends on achieving and maintaining high screening uptake rates. The involvement of GPs in screening has been found to improve patient compliance. Therefore, the endorsement of screening by GPs may increase uptake rates amongst non-responders.
METHODS/DESIGN


A two-armed randomised controlled trial will evaluate the effectiveness of a GP endorsed reminder in improving patient participation in the NHS Bowel Cancer Screening Programme (NHSBCSP). Up to 30 general practices in the West Midlands with a screening uptake rate of less than 50% will be recruited and patients identified from the patient lists of these practices. Eligible patients will be those aged 60 to 74, who have previously been invited to participate in bowel screening but who have been recorded by the Midlands and North West Bowel Cancer Screening Hub as non-responders. Approximately 4,380 people will be randomised in equal numbers to either the intervention (GP letter and duplicate FOBt kit) or control (no additional contact) arms of the trial. The primary outcome measure will be the difference in the uptake rate of FOBt screening for bowel cancer between the intervention and control groups at 13 weeks after the GP endorsed reminder and duplicate FOBt kit are sent. Secondary outcome measures will be subgroup analyses of uptake according to gender, age and deprivation quartile, and the validation of methods for collecting GP, NHSBCSP and patient costs associated with the intervention. Qualitative work (30 to 40 semi-structured interviews) will be undertaken with individuals in the intervention arm who return a FOBt kit, to investigate the relative importance of the duplicate FOBt kit, reminder to participate, and GP endorsement of that reminder in contributing to individuals' decisions to participate in screening.
DISCUSSION


Implementing feasible, acceptable and cost-effective strategies to improve screening uptake amongst non-responders to invitations to participate is fundamentally important for the success of screening programmes. If this feasibility study demonstrates a significant increase in uptake of FOBt screening in individuals receiving the intervention, a definitive, appropriately powered future trial will be designed.
TRIAL REGISTRATION NUMBER


ISRCTN: ISRCTN86784060.",2012,The primary outcome measure will be the difference in the uptake rate of FOBt screening for bowel cancer between the intervention and control groups at 13 weeks after the GP endorsed reminder and duplicate FOBt kit are sent.,"['individuals receiving the intervention', 'Approximately 4,380 people', 'Eligible patients will be those aged 60 to 74, who have previously been invited to participate in bowel screening but who have been recorded by the Midlands and North West Bowel Cancer Screening Hub as non-responders', '30 general practices in the West Midlands with a screening uptake rate of less than 50% will be recruited and patients identified from the patient lists of these practices']","['GP endorsed reminder', 'intervention (GP letter and duplicate FOBt kit) or control (no additional contact', 'GP endorsement', 'NHS Bowel Cancer Screening Programme (NHSBCSP']","['subgroup analyses of uptake according to gender, age and deprivation quartile, and the validation of methods for collecting GP, NHSBCSP and patient costs associated with the intervention', 'uptake rate of FOBt screening for bowel cancer', 'uptake rates', 'uptake of FOBt screening']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0346627', 'cui_str': 'Cancer of Intestines'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0454882', 'cui_str': 'West Midlands (geographic location)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0346627', 'cui_str': 'Cancer of Intestines'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0346627', 'cui_str': 'Cancer of Intestines'}]",4380.0,0.128224,The primary outcome measure will be the difference in the uptake rate of FOBt screening for bowel cancer between the intervention and control groups at 13 weeks after the GP endorsed reminder and duplicate FOBt kit are sent.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Damery', 'Affiliation': 'Primary Care Clinical Sciences, University of Birmingham, Edgbaston, West Midlands, B15 2TT, UK. s.l.damery@bham.ac.uk'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Clements', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Holder', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Nichols', 'Affiliation': ''}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Draper', 'Affiliation': ''}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Clifford', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Parker', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hobbs', 'Affiliation': ''}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Wilson', 'Affiliation': ''}]",Trials,['10.1186/1745-6215-13-18']
88,23026349,"A systems biology approach to studying Tai Chi, physiological complexity and healthy aging: design and rationale of a pragmatic randomized controlled trial.","INTRODUCTION


Aging is typically associated with progressive multi-system impairment that leads to decreased physical and cognitive function and reduced adaptability to stress. Due to its capacity to characterize complex dynamics within and between physiological systems, the emerging field of complex systems biology and its array of quantitative tools show great promise for improving our understanding of aging, monitoring senescence, and providing biomarkers for evaluating novel interventions, including promising mind-body exercises, that treat age-related disease and promote healthy aging.
MATERIAL AND METHODS


An ongoing, two-arm randomized clinical trial is evaluating the potential of Tai Chi mind-body exercise to attenuate age-related loss of complexity. A total of 60 Tai Chi-naïve healthy older adults (aged 50-79) are being randomized to either six months of Tai Chi training (n=30), or to a waitlist control receiving unaltered usual medical care (n=30). Our primary outcomes are complexity-based measures of heart rate, standing postural sway and gait stride interval dynamics assessed at 3 and 6months. Multiscale entropy and detrended fluctuation analysis are used as entropy- and fractal-based measures of complexity, respectively. Secondary outcomes include measures of physical and psychological function and tests of physiological adaptability also assessed at 3 and 6months.
DISCUSSION


Results of this study may lead to novel biomarkers that help us monitor and understand the physiological processes of aging and explore the potential benefits of Tai Chi and related mind-body exercises for healthy aging.",2013,"A total of 60 Tai Chi-naïve healthy older adults (aged 50-79) are being randomized to either six months of Tai Chi training (n=30), or to a waitlist control receiving unaltered usual medical care (n=30).",['60 Tai Chi-naïve healthy older adults (aged 50-79'],"['Tai Chi training', 'waitlist control receiving unaltered usual medical care', 'Tai Chi mind-body exercise']","['complexity-based measures of heart rate, standing postural sway and gait stride interval dynamics assessed at 3 and 6months', 'measures of physical and psychological function and tests of physiological adaptability also assessed at 3 and 6months']","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}]",,0.0607622,"A total of 60 Tai Chi-naïve healthy older adults (aged 50-79) are being randomized to either six months of Tai Chi training (n=30), or to a waitlist control receiving unaltered usual medical care (n=30).","[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02215, USA. pwayne@partners.org""}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': ''}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Novak', 'Affiliation': ''}, {'ForeName': 'Madelena D', 'Initials': 'MD', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': ''}, {'ForeName': 'Ary L', 'Initials': 'AL', 'LastName': 'Goldberger', 'Affiliation': ''}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': ''}, {'ForeName': 'C-K', 'Initials': 'CK', 'LastName': 'Peng', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lough', 'Affiliation': ''}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Mary T', 'Initials': 'MT', 'LastName': 'Quilty', 'Affiliation': ''}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2012.09.006']
89,31539358,The effect of life skills training with health literacy strategies on self-esteem and self-efficacy in female students during puberty.,"BACKGROUND


Puberty is a sensitive period of life for developing specific skills and knowledge and acquiring abilities and attributes that are essential for managing emotions and assuming adult roles. Thus, this has implications for health educational programs to responses to the experimentation and exploration that takes place during puberty.
OBJECTIVES


This study aimed to examine the effect of life skills training using health literacy strategies on self-esteem and self-efficacy in adolescent female students.
METHODS


This was a semi-experimental study with intervention-control groups performed on 96 female students (7th grade of high school) in Mashhad, Iran from January 2017 to Jun 2017. The sampling method was a multi-stage random sampling. The samples were divided into two groups: an intervention group and a control group (each one having 50 subjects) through the simple randomized approach. Data collection tools used were the Coopersmith Self-esteem Questionnaire and Sherer's Self-efficacy Questionnaire. Life skills training for the intervention group consisted of five sessions of theoretical training and workshops with role play and were designed based on health literacy strategies. The pretest, posttest and follow-up (3 months after the intervention) was conducted for both groups. Data analysis was performed using SPSS 19 software (t-test, Mann-Whitney, chi-square (χ 2 ) and repeated data analysis).
RESULTS


Before the intervention, there was no significant difference between the two groups in terms of self-esteem score (p = 0.70) and self-efficacy (p = 0.10), but immediately after training, as well as 3 months later, a significant difference was found between the two groups (p < 0.001).
CONCLUSION


Based on the findings, life skills educational interventions based on health literacy strategies could promote the self-esteem and self-efficacy abilities among female students during puberty.",2019,", there was no significant difference between the two groups in terms of self-esteem score (p = 0.70) and self-efficacy (p = 0.10), but immediately after training, as well as 3 months later, a significant difference was found between the two groups (p < 0.001).","['adolescent female students', 'female students during puberty', '96 female students (7th grade of high school) in Mashhad, Iran from January 2017 to Jun 2017']","['theoretical training and workshops with role play and were designed based on health literacy strategies', 'life skills training using health literacy strategies', 'life skills training with health literacy strategies']","['self-esteem score', 'self-esteem and self-efficacy', ""Coopersmith Self-esteem Questionnaire and Sherer's Self-efficacy Questionnaire"", 'self-esteem and self-efficacy abilities', 'self-efficacy']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0699820', 'cui_str': 'Role playing (finding)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0556562', 'cui_str': 'Life skills training (procedure)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",50.0,0.0195503,", there was no significant difference between the two groups in terms of self-esteem score (p = 0.70) and self-efficacy (p = 0.10), but immediately after training, as well as 3 months later, a significant difference was found between the two groups (p < 0.001).","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Jafarigiv', 'Affiliation': 'Department of Health Education and Health Promotion, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Peyman', 'Affiliation': 'Social Determinants of Health Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2019-0121']
90,22457014,Salbutamol but not ipratropium abolishes leukotriene D4-induced gas exchange abnormalities in asthma.,"PURPOSE


Leukotriene D(4) (LTD(4)) is a central mediator in asthma inducing bronchoconstriction and profound disturbances in pulmonary gas exchange in asthmatic subjects. The aim of the study was to compare, for the first time, the influence of the bronchodilators salbutamol (400 μg) and ipratropium (80 μg) on lung function changes induced by inhaled LTD(4).
METHODS


Treatments were evaluated in a randomized, three-period, double-blind, placebo-controlled, cross-over study where spirometric and pulmonary gas exchange indices were followed in 12 subjects with mild asthma before and after LTD(4) challenge.
RESULTS


Compared with placebo, salbutamol provided significant protection against the fall in FEV(1) (forced expiratory volume in 1 s) after LTD(4) challenge. Salbutamol also abolished the LTD(4)-induced gas exchange disturbances [decreased arterial oxygen tension (PaO(2)) and increased alveolar-arterial oxygen tension difference (AaPO(2))]. Ipratropium provided significant but less marked attenuation of the changes in FEV(1) and arterial oxygenation induced by LTD(4).
CONCLUSION


Despite the equal bronchodilatory effects of salbutamol and ipratropium before the challenge with LTD(4), salbutamol was superior to ipratropium in preventing spirometric and gas exchange abnormalities. This result indicates a broader action of salbutamol on several of the disturbances that contribute to airway obstruction including, for example, exudation of plasma in the airway mucosa. The clinical implication of this new finding is that in this model of acute asthmatic airway obstruction, salbutamol was more effective than ipratropium.",2012,"Compared with placebo, salbutamol provided significant protection against the fall in FEV(1)","['asthmatic subjects', '12 subjects with mild asthma before and after LTD(4) challenge']","['bronchodilators salbutamol (400\xa0μg) and ipratropium', 'placebo', 'salbutamol and ipratropium', 'ipratropium', 'LTD(4', 'Salbutamol', 'placebo, salbutamol', 'Ipratropium', 'salbutamol', 'Leukotriene D(4) (LTD(4']","['spirometric and gas exchange abnormalities', 'FEV(1) and arterial oxygenation induced by LTD(4', 'LTD(4)-induced gas exchange disturbances [decreased arterial oxygen tension (PaO(2)) and increased alveolar-arterial oxygen tension difference (AaPO(2', 'fall in FEV(1']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}]","[{'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0027235', 'cui_str': 'Ipratropium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023548', 'cui_str': 'Leukotrienes D'}]","[{'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial (procedure)'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0429685', 'cui_str': 'Alveolar-arterial oxygen tension difference (observable entity)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]",12.0,0.127293,"Compared with placebo, salbutamol provided significant protection against the fall in FEV(1)","[{'ForeName': 'Barbro', 'Initials': 'B', 'LastName': 'Dahlén', 'Affiliation': 'Lung and Allergy Clinic, Department of Medicine at Karolinska University Hospital Huddinge and The Centre for Allergy Research, Karolinska Institutet, 141 86, Stockholm, Sweden. barbro.dahlen@ki.se'}, {'ForeName': 'Federico P', 'Initials': 'FP', 'LastName': 'Gómez', 'Affiliation': ''}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Casas', 'Affiliation': ''}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Howarth', 'Affiliation': ''}, {'ForeName': 'Sven-Erik', 'Initials': 'SE', 'LastName': 'Dahlén', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rodriguez-Roisin', 'Affiliation': ''}]",European journal of clinical pharmacology,['10.1007/s00228-012-1256-z']
91,31539025,Preoperative VolumE Replacement therapy in DIabetic patients undergoing coronary artery bypass grafting surgery: results from an open parallel group randomized Controlled Trial (VeRDiCT).,"OBJECTIVES


To investigate the effect of preoperative volume replacement therapy (VRT) on renal function, health outcome and time to fitness for discharge in diabetic patients undergoing coronary artery bypass grafting (CABG).
METHODS


In 2 parallel randomized controlled trials, diabetic patients were allocated to preoperative VRT (1 ml/kg/h of Hartmann's solution for 12 h) or usual care. Primary outcome was time to fitness for discharge. Secondary outcomes included acute kidney injury, postoperative complications, patient-reported quality of life (QoL), hospital resource use and markers of renal, cardiac and inflammatory injury.
RESULTS


In total, 169 patients were randomized (84 VRT, 85 usual care; mean age 64 years; 88% male). Time to fitness for discharge was similar between groups [median 6 days; interquartile range 5.0-9.0 in both groups; hazard ratio 0.95, 95% confidence interval (CI) 0.65-1.38; P = 0.78]. Postoperative acute kidney injury was not statistically different (VRT: 27.7% vs usual care: 18.8%, odds ratio 1.72, 95% CI 0.82-3.59; P = 0.15). Estimated glomerular filtration rate (mean difference -0.92, 95% CI -4.18 to 2.25; P = 0.56), microalbumin/creatinine ratio [geometric mean ratio (GMR) 1.16, 95% CI 0.94-1.42; P = 0.16], N-acetyl-beta-d-glucosaminidase (GMR 1.08, 95% CI 0.83-1.40; P = 0.57), C-reactive protein (GMR 1.00, 95% CI 0.88-1.13; P = 0.94), troponin T (Trop-T; GMR 1.18, 95% CI 0.78-1.79; P = 0.39) and other secondary health outcomes were similar between groups. QoL improved in both groups at 3 months with no difference observed.
CONCLUSIONS


The use of preoperative VRT is not superior to usual care in diabetic patients undergoing CABG.
CLINICAL TRIAL REGISTRATION NUMBER


ISRCTN02159606.",2020,"Estimated glomerular filtration rate (mean difference -0.92, 95% CI -4.18 to 2.25; P = 0.56), microalbumin/creatinine ratio [geometric mean ratio (GMR)","['diabetic patients', '169 patients were randomized (84 VRT, 85 usual care; mean age 64\u2009years; 88% male', 'diabetic patients undergoing coronary artery bypass grafting (CABG', 'DIabetic patients undergoing coronary artery bypass grafting surgery', 'diabetic patients undergoing CABG']","['preoperative VRT', 'Preoperative VolumE Replacement therapy', ""preoperative VRT (1\u2009ml/kg/h of Hartmann's solution for 12\u2009h) or usual care"", 'preoperative volume replacement therapy (VRT']","['Postoperative acute kidney injury', 'Time to fitness for discharge', 'time to fitness for discharge', 'acute kidney injury, postoperative complications, patient-reported quality of life (QoL), hospital resource use and markers of renal, cardiac and inflammatory injury', 'renal function, health outcome and time to fitness for discharge', 'secondary health outcomes', 'microalbumin/creatinine ratio [geometric mean ratio (GMR', 'C-reactive protein', 'QoL', 'Estimated glomerular filtration rate']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0521302', 'cui_str': 'Body fluid replacement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034380'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C3811844'}]",169.0,0.370451,"Estimated glomerular filtration rate (mean difference -0.92, 95% CI -4.18 to 2.25; P = 0.56), microalbumin/creatinine ratio [geometric mean ratio (GMR)","[{'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Sarkar', 'Affiliation': 'Rabindranath Tagore International Institute of Cardiac Sciences (RTIICS), Kolkata, India.'}, {'ForeName': 'Rosie A', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Wells', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Clout', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Culliford', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Gianni D', 'Initials': 'GD', 'LastName': 'Angelini', 'Affiliation': 'Faculty of Health Sciences, Bristol Heart Institute, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Pike', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ashton', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Rabindranath Tagore International Institute of Cardiac Sciences (RTIICS), Kolkata, India.'}, {'ForeName': 'Barney', 'Initials': 'B', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hillier', 'Affiliation': 'Faculty of Health Sciences, Bristol Heart Institute, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Ascione', 'Affiliation': 'Faculty of Health Sciences, Bristol Heart Institute, University of Bristol, Bristol, UK.'}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivz226']
92,21953370,Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results.,"BACKGROUND


Sustained benefits of drug-eluting stents in femoropopliteal arteries have not been demonstrated. This prospective, multinational, randomized study was designed to compare the 12-month safety and effectiveness of a polymer-free, paclitaxel-coated nitinol drug-eluting stent (DES) with percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement in patients with femoropopliteal peripheral artery disease.
METHODS AND RESULTS


Patients were randomly assigned to primary DES implantation (n=236) or PTA (n=238). Demographics and lesion characteristics were similar between groups (eg, average lesion length, approximately 65±40 mm). One hundred twenty patients had acute PTA failure and underwent secondary random assignment to provisional DES (n=61) or BMS (n=59). Primary end points were the 12-month rates of event-free survival and patency in the primary DES and PTA groups. Compared with the PTA group, the primary DES group exhibited superior 12-month event-free survival (90.4% versus 82.6%; P=0.004) and primary patency (83.1% versus 32.8%; P<0.001), satisfying the primary hypotheses. In the secondary evaluations, (1) the primary DES group exhibited superior clinical benefit compared with the PTA group (88.3% versus 75.8%; P<0.001), (2) the provisional DES group exhibited superior primary patency (89.9% versus 73.0%; P=0.01) and superior clinical benefit (90.5% and 72.3%, P=0.009) compared with the provisional BMS group, and (3) the stent fracture rate (both DES and BMS) was 0.9% (4/457).
CONCLUSIONS


Femoropopliteal peripheral artery disease treatment with the paclitaxel-eluting stent was associated with superior 12-month outcomes compared with PTA and provisional BMS placement.",2011,Primary end points were the 12-month rates of event-free survival and patency in the primary DES and PTA groups.,"['femoropopliteal disease', 'patients with femoropopliteal peripheral artery disease', 'Patients were randomly assigned to primary DES implantation (n=236) or PTA (n=238', 'One hundred twenty patients had acute PTA failure and underwent secondary random assignment to provisional DES (n=61) or BMS (n=59']","['percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement', 'paclitaxel-eluting stent', 'polymer-free, paclitaxel-coated nitinol drug-eluting stent (DES', 'PTA', 'balloon angioplasty and bare metal stents', 'Paclitaxel-eluting stents']","['stent fracture rate', 'superior primary patency', 'superior clinical benefit', 'superior 12-month event-free survival', 'primary patency', 'Demographics and lesion characteristics', '12-month rates of event-free survival and patency']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}]","[{'cui': 'C2936666', 'cui_str': 'Percutaneous Transluminal Angioplasty'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0068790', 'cui_str': 'nickel titanium'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}]","[{'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",,0.123109,Primary end points were the 12-month rates of event-free survival and patency in the primary DES and PTA groups.,"[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Dake', 'Affiliation': 'Department of Cardiothoracic Surgery, Stanford University School of Medicine, Falk Cardiovascular Research Center, 300 Pasteur Drive, Stanford, CA 94305-5407, USA. mddake@stanford.edu'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Ansel', 'Affiliation': ''}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jaff', 'Affiliation': ''}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ohki', 'Affiliation': ''}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Saxon', 'Affiliation': ''}, {'ForeName': 'H Bob', 'Initials': 'HB', 'LastName': 'Smouse', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': ''}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Roubin', 'Affiliation': ''}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Burket', 'Affiliation': ''}, {'ForeName': 'Yazan', 'Initials': 'Y', 'LastName': 'Khatib', 'Affiliation': ''}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Snyder', 'Affiliation': ''}, {'ForeName': 'Anthony O', 'Initials': 'AO', 'LastName': 'Ragheb', 'Affiliation': ''}, {'ForeName': 'J King', 'Initials': 'JK', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Lindsay S', 'Initials': 'LS', 'LastName': 'Machan', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.111.962324']
93,22011096,Alignment efficiency of superelastic coaxial nickel-titanium vs superelastic single-stranded nickel-titanium in relieving mandibular anterior crowding: a randomized controlled prospective study.,"OBJECTIVE


To clinically evaluate the alignment efficiency of 0.016-inch coaxial superelastic nickel-titanium (NiTi) and 0.016-inch superelastic NiTi in the lower anterior region over a period of 12 weeks.
MATERIALS AND METHODS


A sample of 24 patients requiring lower anterior alignment were included in this single-center, single-operator, double-blind clinical trial and were randomly allocated into two groups of 12 patients. The type of wire selected for each patient was not disclosed to the provider or to the patient. Comparison of pretreatment characteristics of the archwire groups revealed no discrimination between two samples, thus verifying the random allocation of the intervention. An initial alginate impression of the lower arch was followed by impressions at 4-, 8-, and 12-week intervals. Casts were measured using the coordinate measuring machine to denote the degree of alignment. Duplicate readings of the cast series were taken to assess measurement variation.
RESULTS


A statistically significant difference (P < .05) in the mean values of tooth movement demonstrated the superior aligning efficiency of coaxial superelastic NiTi over single-stranded superelastic NiTi in relieving lower anterior crowding. The measurement error recorded was within acceptable limits, with range values within 95% limits of agreement.
CONCLUSION


Coaxial superelastic NiTi wire proved superior to single-stranded NiTi in its efficiency in relieving lower anterior crowding over a 12-week period.",2012,A statistically significant difference (P < .05) in the mean values of tooth movement demonstrated the superior aligning efficiency of coaxial superelastic NiTi over single-stranded superelastic NiTi in relieving lower anterior crowding.,"['relieving mandibular anterior crowding', '24 patients requiring lower anterior alignment']","['coaxial superelastic nickel-titanium (NiTi) and 0.016-inch superelastic NiTi', 'superelastic coaxial nickel-titanium vs superelastic single-stranded nickel-titanium']",[],"[{'cui': 'C1301771', 'cui_str': 'Relieved'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior (qualifier value)'}]","[{'cui': 'C0068790', 'cui_str': 'nickel titanium'}, {'cui': 'C0450303', 'cui_str': '0.016""'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]",[],24.0,0.0887357,A statistically significant difference (P < .05) in the mean values of tooth movement demonstrated the superior aligning efficiency of coaxial superelastic NiTi over single-stranded superelastic NiTi in relieving lower anterior crowding.,"[{'ForeName': 'Biju', 'Initials': 'B', 'LastName': 'Sebastian', 'Affiliation': 'Department of Orthodontics, Noorul Islam College of Dental Sciences, Trivandrum, Kerala India. drbijuseb00@gmail.com'}]",The Angle orthodontist,['10.2319/072111-460.1']
94,21612469,Effect of bronchoconstriction on airway remodeling in asthma.,"BACKGROUND


Asthma is characterized pathologically by structural changes in the airway, termed airway remodeling. These changes are associated with worse long-term clinical outcomes and have been attributed to eosinophilic inflammation. In vitro studies indicate, however, that the compressive mechanical forces that arise during bronchoconstriction may induce remodeling independently of inflammation. We evaluated the influence of repeated experimentally induced bronchoconstriction on airway structural changes in patients with asthma.
METHODS


We randomly assigned 48 subjects with asthma to one of four inhalation challenge protocols involving a series of three challenges with one type of inhaled agent presented at 48-hour intervals. The two active challenges were with either a dust-mite allergen (which causes bronchoconstriction and eosinophilic inflammation) or methacholine (which causes bronchoconstriction without eosinophilic inflammation); the two control challenges (neither of which causes bronchoconstriction) were either saline alone or albuterol followed by methacholine (to control for nonbronchoconstrictor effects of methacholine). Bronchial-biopsy specimens were obtained before and 4 days after completion of the challenges.
RESULTS


Allergen and methacholine immediately induced similar levels of bronchoconstriction. Eosinophilic inflammation of the airways increased only in the allergen group, whereas both the allergen and the methacholine groups had significant airway remodeling not seen in the two control groups. Subepithelial collagen-band thickness increased by a median of 2.17 μm in the allergen group (interquartile range [IQR], 0.70 to 3.67) and 1.94 μm in the methacholine group (IQR, 0.37 to 3.24) (P<0.001 for the comparison of the two challenge groups with the two control groups); periodic acid-Schiff staining of epithelium (mucus glands) also increased, by a median of 2.17 percentage points in the allergen group (IQR, 1.03 to 4.77) and 2.13 percentage points in the methacholine group (IQR, 1.14 to 7.96) (P=0.003 for the comparison with controls). There were no significant differences between the allergen and methacholine groups.
CONCLUSIONS


Bronchoconstriction without additional inflammation induces airway remodeling in patients with asthma. These findings have potential implications for management.",2011,"Eosinophilic inflammation of the airways increased only in the allergen group, whereas both the allergen and the methacholine groups had significant airway remodeling not seen in the two control groups.","['asthma', '48 subjects with asthma to one of four inhalation challenge protocols involving a series of three challenges with one type of inhaled agent presented at 48-hour intervals', 'patients with asthma']","['saline alone or albuterol followed by methacholine', 'bronchoconstriction', 'methacholine']","['Eosinophilic inflammation of the airways', 'Subepithelial collagen-band thickness', 'levels of bronchoconstriction', 'periodic acid-Schiff staining of epithelium (mucus glands']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0600370', 'cui_str': 'Methacholine'}, {'cui': 'C0079043', 'cui_str': 'Bronchial Constriction'}]","[{'cui': 'C3687252', 'cui_str': 'Eosinophilic inflammation (morphologic abnormality)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079043', 'cui_str': 'Bronchial Constriction'}, {'cui': 'C0440048', 'cui_str': 'Periodic acid schiff'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0014609', 'cui_str': 'Epithelial Tissue'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}]",48.0,0.0304051,"Eosinophilic inflammation of the airways increased only in the allergen group, whereas both the allergen and the methacholine groups had significant airway remodeling not seen in the two control groups.","[{'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Grainge', 'Affiliation': 'Division of Infection, Inflammation and Immunity, University of Southampton School of Medicine, Southampton, United Kingdom.'}, {'ForeName': 'Laurie C K', 'Initials': 'LC', 'LastName': 'Lau', 'Affiliation': ''}, {'ForeName': 'Jonathon A', 'Initials': 'JA', 'LastName': 'Ward', 'Affiliation': ''}, {'ForeName': 'Valdeep', 'Initials': 'V', 'LastName': 'Dulay', 'Affiliation': ''}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Lahiff', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Holgate', 'Affiliation': ''}, {'ForeName': 'Donna E', 'Initials': 'DE', 'LastName': 'Davies', 'Affiliation': ''}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Howarth', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1014350']
95,21512184,Cost effectiveness of warfarin versus aspirin in patients older than 75 years with atrial fibrillation.,"BACKGROUND AND PURPOSE


Oral anticoagulants are effective at reducing stroke compared with aspirin in atrial fibrillation patients older than 75 years. Although the benefits of reduced stroke risk outweigh the risks of bleeding, the cost effectiveness of warfarin in this patient population has not yet been established.
METHODS


An economic evaluation was conducted alongside a randomized, controlled trial; 973 patients ≥75 years of age with atrial fibrillation were recruited from primary care and randomly assigned to either take warfarin or aspirin. Follow-up was for a mean of 2.7 years. Costs of thrombotic and hemorrhagic events, anticoagulation clinic visits, and primary care utilization were determined. Clinical benefits were expressed in terms of a primary event avoided: fatal/nonfatal disabling stroke, intracranial hemorrhage, or systemic embolism. A cost-utility analysis was performed using quality-adjusted life years as the benefit measure.
RESULTS


Total costs over 4 years were lower in the warfarin group (difference, -£165; 95% CI, -£452-£89), primarily driven by the difference in primary event costs. The primary event rate over 4 years was lower in the warfarin group (0.049 versus 0.099), and the quality-adjusted life years score was higher (difference, 0.02; 95% CI, -0.07-0.11). With lower costs and a higher quality-adjusted life years score, warfarin is the dominant treatment, but the differences in both costs and effects are small.
CONCLUSIONS


Warfarin is cost-effective compared with aspirin in atrial fibrillation patients age ≥75 years. These data support the anticoagulant therapy option in this high-risk patient population. However, the small differences in costs and effects indicate the importance of exploring patient preferences.",2011,"The primary event rate over 4 years was lower in the warfarin group (0.049 versus 0.099), and the quality-adjusted life years score was higher (difference, 0.02; 95% CI, -0.07-0.11).","['patients older than 75 years with atrial fibrillation', 'atrial fibrillation patients older than 75 years', '973 patients ≥75 years of age with atrial fibrillation were recruited from primary care', 'atrial fibrillation patients age ≥75 years']","['warfarin versus aspirin', 'warfarin', 'aspirin', 'warfarin or aspirin', 'Warfarin']","['fatal/nonfatal disabling stroke, intracranial hemorrhage, or systemic embolism', 'Cost effectiveness', 'Costs of thrombotic and hemorrhagic events, anticoagulation clinic visits, and primary care utilization', 'Total costs', 'primary event rate over 4 years', 'quality-adjusted life years score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3839946', 'cui_str': 'Anticoagulation clinic'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",973.0,0.121514,"The primary event rate over 4 years was lower in the warfarin group (0.049 versus 0.099), and the quality-adjusted life years score was higher (difference, 0.02; 95% CI, -0.07-0.11).","[{'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Health Economics Unit, Public Health Building, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK. s.jowett@bham.ac.uk'}, {'ForeName': 'Stirling', 'Initials': 'S', 'LastName': 'Bryan', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mant', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Fletcher', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Roalfe', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitzmaurice', 'Affiliation': ''}, {'ForeName': 'Gregory Y H', 'Initials': 'GY', 'LastName': 'Lip', 'Affiliation': ''}, {'ForeName': 'F D Richard', 'Initials': 'FD', 'LastName': 'Hobbs', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.110.600767']
96,22044116,Longitudinal assessment of periodontal status in patients with nickel allergy treated with conventional and nickel-free braces.,"OBJECTIVE


To perform a longitudinal comparison of periodontal status in allergic individuals treated with conventional and nickel-free braces.
MATERIALS AND METHODS


Forty-two individuals allergic to nickel were randomly divided into two groups: those receiving conventional braces (n  =  21) and those receiving nickel-free braces (n  =  21). Periodontal status (gingival hyperplasia, change in color and bleeding) was assessed before treatment (T0) and at 3-month intervals for 12 months (T1, T2, T3, and T4), using the Löe Index. Evaluations were performed blindly by a single, calibrated examiner, followed by prophylaxis and orientations regarding oral hygiene. Data were analyzed using the Mann-Whitney U-test for comparisons of the gingival index between groups and Friedman's test for successive comparisons between sessions in the same group (P ≤ .05).
RESULTS


Periodontal status did not differ between groups in the initial 9 months of treatment, whereas significant differences were found at T3 and T4 (.039 and .047, respectively). Individuals wearing conventional appliances had higher mean gingival index scores than those wearing nickel-free braces.
CONCLUSION


Individuals with an allergy to nickel exhibit better periodontal health when treated with nickel-free braces than with conventional braces.",2012,Individuals with an allergy to nickel exhibit better periodontal health when treated with nickel-free braces than with conventional braces.,"['allergic individuals treated with conventional and nickel-free braces', 'Forty-two individuals allergic to nickel', 'Individuals with an allergy to nickel exhibit better periodontal health', 'patients with nickel allergy treated with conventional and nickel-free braces']",['conventional braces (n \u200a=\u200a 21) and those receiving nickel-free braces'],"['Periodontal status (gingival hyperplasia, change in color and bleeding', 'Periodontal status', 'mean gingival index scores']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0028013', 'cui_str': 'nickel'}, {'cui': 'C0006086', 'cui_str': 'Braces'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C1690547', 'cui_str': 'Allergy to nickel'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0006086', 'cui_str': 'Braces'}, {'cui': 'C0028013', 'cui_str': 'nickel'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0017566', 'cui_str': 'Gingival Hyperplasia'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",42.0,0.015325,Individuals with an allergy to nickel exhibit better periodontal health when treated with nickel-free braces than with conventional braces.,"[{'ForeName': 'Camila Alessandra', 'Initials': 'CA', 'LastName': 'Pazzini', 'Affiliation': 'Pediatric Dentistry and Orthodontics Department, Universidade Federal de Minas Gerais-UFMG, Belo Horizonte-MG, Brazil.'}, {'ForeName': 'Leandro Silva', 'Initials': 'LS', 'LastName': 'Marques', 'Affiliation': ''}, {'ForeName': 'Maria Letícia', 'Initials': 'ML', 'LastName': 'Ramos-Jorge', 'Affiliation': ''}, {'ForeName': 'Gilberto Oliveira', 'Initials': 'GO', 'LastName': 'Júnior', 'Affiliation': ''}, {'ForeName': 'Luciano José', 'Initials': 'LJ', 'LastName': 'Pereira', 'Affiliation': ''}, {'ForeName': 'Saul Martins', 'Initials': 'SM', 'LastName': 'Paiva', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/080211-487.1']
97,20345421,Effect-site concentration of remifentanil attenuating surgical stress index responses to intubation of the trachea.,"Surgical Stress Index has been proposed for assessment of surgical stress and analgesia. It is a numeric index based on the normalised pulse beat interval and photoplethysmographic pulse wave amplitude. We determined the effect-site concentration of remifentanil for attenuation of Surgical Stress Index responses to intubation of the trachea. Thirty ASA 1-2 patients received either deep or normal anaesthesia and then target-controlled remifentanil. Burst suppression was maintained in the deep group and state entropy at 40-60 (scale 0-91) in the normal group. Mean (SD) effect-site concentrations of remifentanil attenuating responses in 50% of patients were 2.13 (0.25) ng x ml(-1) and 3.05 (0.27) ng x ml(-1) in deep and normal groups, respectively (p = 0.034). From probit analysis, EC(50) and EC(95) of remifentanil (95% CI) were 2.34 (1.97-2.71) ng x ml(-1) and 3.19 (2.69-3.69) ng x ml(-1) in deep group and 3.17 (2.67-3.67) ng x ml(-1) and 3.79 (3.21-4.37) ng x ml(-1) in the normal group, respectively. The values from probit analysis and up-and-down method did not differ significantly.",2010,Burst suppression was maintained in the deep group and state entropy at 40-60 (scale 0-91) in the normal group.,[],"['deep or normal anaesthesia and then target-controlled remifentanil', 'remifentanil']","['Burst suppression', 'Mean (SD) effect-site concentrations of remifentanil attenuating responses']",[],"[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0429306', 'cui_str': 'Burst suppression (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]",,0.167543,Burst suppression was maintained in the deep group and state entropy at 40-60 (scale 0-91) in the normal group.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mustola', 'Affiliation': 'Specialist Doctor.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Toivonen', 'Affiliation': 'Chief Physician, Department of Anaesthesia, South Carelia Central Hospital, Lappeenranta, Finland.'}]",Anaesthesia,['10.1111/j.1365-2044.2010.06329.x']
98,20412150,Effect of midazolam on memory: a study of process dissociation procedure and functional magnetic resonance imaging.,"To assess the effects of midazolam on explicit and implicit memories, 12 volunteers were randomly divided into the two groups: one with an Observer's Assessment of Alertness/Sedation score of 3 (mild sedation) and one with a score of 1 (deep sedation). Blood oxygen-level-dependent functional magnetic resonance imaging was measured before and during an auditory stimulus, then with midazolam sedation, and then during a second auditory stimulus with continuous midazolam sedation. After 4 h, explicit and implicit memories were assessed. There was no evidence of explicit memory at the two levels of midazolam sedation. Implicit memory was retained at a mild level of midazolam sedation but absent at a deep level of midazolam sedation. At a mild level of midazolam sedation, activation of all brain areas by auditory stimulus (as measured by functional magnetic resonance imaging) was uninhibited. However, a deep level of midazolam sedation depressed activation of the superior temporal gyrus by auditory stimulus. We conclude that midazolam does not abolish implicit memory at a mild sedation level, but can abolish both explicit and implicit memories at a deep sedation level. The superior temporal gyrus may be one of the target areas.",2010,Implicit memory was retained at a mild level of midazolam sedation but absent at a deep level of midazolam sedation.,['12 volunteers'],"['midazolam sedation', 'midazolam']","['Blood oxygen-level-dependent functional magnetic resonance imaging', 'Implicit memory', 'memory', 'explicit memory']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0561768', 'cui_str': 'Implicit memory (observable entity)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0561766', 'cui_str': 'Explicit memory (observable entity)'}]",12.0,0.0692795,Implicit memory was retained at a mild level of midazolam sedation but absent at a deep level of midazolam sedation.,"[{'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Tian', 'Affiliation': 'Visiting Anaesthetist.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Vice Professor.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Quan', 'Affiliation': 'Resident.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Resident.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Xue', 'Affiliation': ""Professor, Department of Anaesthesiology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Ye', 'Affiliation': 'Professor, Department of Anaesthesiology, Peking Union Medical College Hospital.'}]",Anaesthesia,['10.1111/j.1365-2044.2010.06343.x']
99,20412149,Differences between bispectral index and spectral entropy during xenon anaesthesia: a comparison with propofol anaesthesia.,"We enrolled 114 patients, aged 65-83 years, undergoing elective surgery (duration > 2h) into a randomised, controlled study to evaluate the performance of bispectral index and spectral entropy for monitoring depth of xenon versus propofol anaesthesia. In the propofol group, bispectral index and state entropy values were comparable. In the xenon group, bispectral index values resembled those in the propofol group, but spectral entropy levels were significantly lower. Mean arterial blood pressure was higher and heart rate was lower in the xenon group than in the propofol group. Bispectral index and spectral entropy considerably diverged during xenon but not during propofol anaesthesia. We therefore conclude that these measures are not interchangeable for the assessment of depth of hypnosis and that bispectral index is likely to reflect actual depth of anaesthesia more precisely compared with spectral entropy.",2010,Mean arterial blood pressure was higher and heart rate was lower in the xenon group than in the propofol group.,"['114 patients, aged 65-83 years, undergoing elective surgery (duration > 2h']","['propofol anaesthesia', 'propofol']","['spectral entropy levels', 'heart rate', 'Bispectral index and spectral entropy', 'bispectral index and state entropy values', 'bispectral index values', 'bispectral index and spectral entropy', 'Mean arterial blood pressure']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}]",114.0,0.0703675,Mean arterial blood pressure was higher and heart rate was lower in the xenon group than in the propofol group.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Höcker', 'Affiliation': 'Staff Anaesthesiologist.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Raitschew', 'Affiliation': 'Staff Anaesthesiologist.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Meybohm', 'Affiliation': 'Staff Anaesthesiologist.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Broch', 'Affiliation': 'Staff Anaesthesiologist.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stapelfeldt', 'Affiliation': 'Staff Anaesthesiologist.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gruenewald', 'Affiliation': 'Staff Anaesthesiologist.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cavus', 'Affiliation': 'Staff Anaesthesiologist.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Steinfath', 'Affiliation': 'Professor and Chair.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bein', 'Affiliation': 'Associate Professor, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}]",Anaesthesia,['10.1111/j.1365-2044.2010.06344.x']
100,20565392,Continuous patient-controlled epidural infusion of levobupivacaine plus sufentanil in labouring primiparous women: effects of concentration.,"The effects of two different concentrations of epidural levobupivacaine were compared when used to provide analgesia for labour. Primiparous women in spontaneous uncomplicated labour were enrolled in a prospective, randomised and partially double-blinded study. The study solutions were either 0.568 mg x ml(-1) levobupivacaine (low concentration group) or 1.136 mg x ml(-1) levobupivacaine (high concentration group), with sufentanil 0.45 microg x ml(-1) added to both solutions. Epidural analgesia was initiated with 20 ml of the study solution, followed by a standardised algorithm of top-up bolus injections. Epidural analgesia was then continued by self-administered boluses of 5-ml plus a continuous infusion of 5 ml x h(-1). Analgesia was found to be more efficacious in the high-concentration group. The dose of levobupivacaine administered was higher and sometimes overstepping recommended limits in the high concentration group, but with no observed increase in side-effects. The choice between these two concentrations may still be made according to the patient's and the practitioner's preferences. The effects of an intermediate concentration should be studied in the future.",2010,Analgesia was found to be more efficacious in the high-concentration group.,"['labouring primiparous women', 'Primiparous women in spontaneous uncomplicated labour']","['sufentanil 0.45 microg x ml(-1) added to both solutions', 'epidural levobupivacaine', 'levobupivacaine plus sufentanil', 'levobupivacaine (low concentration group) or 1.136 mg x ml(-1) levobupivacaine', 'levobupivacaine', 'Epidural analgesia']",['side-effects'],"[{'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0704674,Analgesia was found to be more efficacious in the high-concentration group.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tixier', 'Affiliation': 'Hospital Practitioner, CHU Clermont-Ferrand, Pôle Anesthésie-Réanimation-Hôtel-Dieu, Polyclinique.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bonnin', 'Affiliation': 'Hospital Practitioner, CHU Clermont-Ferrand, Pôle Anesthésie-Réanimation-Hôtel-Dieu, Polyclinique.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bolandard', 'Affiliation': 'Hospital Practitioner, CHU Clermont-Ferrand, Pôle Anesthésie-Réanimation-Hôtel-Dieu, Polyclinique.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vernis', 'Affiliation': 'Hospital Practitioner, CHU Clermont-Ferrand, Pôle Anesthésie-Réanimation-Hôtel-Dieu, Polyclinique.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lavergne', 'Affiliation': 'Hospital Practitioner, CHU Clermont-Ferrand, Pôle Anesthésie-Réanimation-Hôtel-Dieu, Polyclinique.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Bazin', 'Affiliation': 'Hospital Practitioner, CHU Clermont-Ferrand, Pôle Anesthésie-Réanimation-Hôtel-Dieu, Polyclinique.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dualé', 'Affiliation': 'Resident/Hospital Practitioner, CHU Clermont-Ferrand, Pôle Anesthésie-Réanimation-SAMU-SMUR, Hôpital Gabriel-Montpied.'}]",Anaesthesia,['10.1111/j.1365-2044.2010.06369.x']
101,20439044,Prevalence of delirium on admission to postacute care is associated with a higher number of nursing home deficiencies.,"OBJECTIVE


To examine the association between the prevalence of delirium among patients admitted to postacute care and the quality of nursing home care as reflected in deficiency counts.
DESIGN


Analysis of screening data from a randomized controlled trial (RCT) of a delirium abatement program.
SETTING AND PARTICIPANTS


We screened 4744 of 6352 RCT-eligible persons admitted to 1 of 8 skilled nursing facilities in the Boston area over a 3-year period. Quality of care was operationalized with the count of deficiencies noted by state surveyors.
MEASUREMENTS


Prevalence of Confusion Assessment Method (CAM) diagnoses of delirium as completed by trained research interviewers at each facility.
RESULTS


About 1 in 7 persons admitted to postacute care met CAM criteria for delirium, but this varied from 1 in 15 to 1 in 4 across facilities. The correlation of deficiency count per 100 beds and the prevalence of CAM delirium was strong (r=0.45) and significant (95% Confidence interval =0.07, 0.71).
CONCLUSION


Although this study is limited by small sample size, limited geographic scope, and crude assessment of quality with deficiency counts, we have found that facilities with more deficiencies admit more persons that satisfy CAM criteria for delirium. It is possible that good facilities often choose to admit and/or are referred good candidates for rehabilitation, whereas facilities with more deficiencies are not able to be so selective. The end result may be that delirious patients are being preferentially admitted to poorer quality facilities, increasing their likelihood of poor postacute outcomes.",2010,"The correlation of deficiency count per 100 beds and the prevalence of CAM delirium was strong (r=0.45) and significant (95% Confidence interval =0.07, 0.71).
","['7 persons admitted to postacute care', 'patients admitted to postacute care', 'We screened 4744 of 6352 RCT-eligible persons admitted to 1 of 8 skilled nursing facilities in the Boston area over a 3-year period']",[],"['Prevalence of Confusion Assessment Method (CAM) diagnoses of delirium', 'correlation of deficiency count per 100 beds and the prevalence of CAM delirium']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0376635', 'cui_str': 'Post-acute Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037265', 'cui_str': 'Extended Care Facilities'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}]",,0.0611679,"The correlation of deficiency count per 100 beds and the prevalence of CAM delirium was strong (r=0.45) and significant (95% Confidence interval =0.07, 0.71).
","[{'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': 'Institute for Aging Research, Hebrew SeniorLife, Boston, MA 02131, USA. jones@hrca.harvard.edu'}, {'ForeName': 'Dan K', 'Initials': 'DK', 'LastName': 'Kiely', 'Affiliation': ''}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Marcantonio', 'Affiliation': ''}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2009.08.009']
102,20412151,A comparison of the Airway Scope and McCoy laryngoscope in patients with simulated restricted neck mobility.,"We compared the efficacy of the Airway Scope and McCoy laryngoscope as intubation tools with the neck stabilised by a rigid cervical collar. After induction of anaesthesia and neck stabilisation, 100 patients were randomly assigned to tracheal intubation with an Airway Scope or McCoy laryngoscope. Overall intubation success rate, time required for intubation, number of intubation attempts required for successful intubation, and airway complications related to intubation were recorded. Overall intubation success rates were 100% with both devices and a similar number of intubation attempts were required. However, the mean (SD) time required for successful intubation was shorter with the Airway Scope (30 (7) s) than with the McCoy laryngoscope (40 (14) s; p < 0.0001). The incidences of intubation complications were similar, but oesophageal intubation (in six cases) occurred only with McCoy laryngoscope.",2010,"Overall intubation success rate, time required for intubation, number of intubation attempts required for successful intubation, and airway complications related to intubation were recorded.","['patients with simulated restricted neck mobility', '100 patients']","['Airway Scope and McCoy laryngoscope', 'tracheal intubation with an Airway Scope or McCoy laryngoscope']","['incidences of intubation complications', 'Overall intubation success rates', 'mean (SD) time required for successful intubation', 'Overall intubation success rate, time required for intubation, number of intubation attempts required for successful intubation, and airway complications related to intubation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1504364', 'cui_str': 'Intubation complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",100.0,0.0667602,"Overall intubation success rate, time required for intubation, number of intubation attempts required for successful intubation, and airway complications related to intubation were recorded.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Komatsu', 'Affiliation': 'Neuroanesthesia Fellow, Departments of General Anesthesiology and Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kamata', 'Affiliation': 'Attending Anaesthesiologist, Department of Anesthesia, Kosei Hospital, Tokyo, Japan.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Professor and Chair, Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ozaki', 'Affiliation': ""Professor and Chair, Department of Anesthesiology, Tokyo Women's Medical University, Tokyo, Japan.""}]",Anaesthesia,['10.1111/j.1365-2044.2010.06334.x']
103,15305197,A randomised comparison of UK genetic risk counselling services for familial cancer: psychosocial outcomes.,"The aim of the study was to compare psychosocial outcomes for 50 new clinic attendees, referred for cancer genetic counselling to five UK centres. The centres represented England, Scotland and Wales, and were randomly selected from groups ranked by different levels of clinical activity in cancer genetics practice. Questionnaires assessed demographic data, risk perception, mental health and use of health services pre-consultation and at 1 and 12 months follow-up. Satisfaction was measured for attendees and referring doctors at follow-up. A total of 256 unaffected adults fulfilled the study criteria. The five centres varied widely with respect to service organisation and activity, but all had a greater proportion of unaffected attendees with a breast cancer risk (61-91%) than either a bowel cancer risk (0-33%) or ovarian cancer risk (3-25%). There were no significant differences in the psychosocial data between centres pre-counselling. No significant change over time occurred for any of the centres for risk perception or general psychological distress. There were significant differences between centres in reduction of cancer worry from baseline to 12 months and with the number of women who were recommended to have mammographic surveillance who had not received this. Overall, one-third of women for whom mammography had been recommended had not been screened within 1 year of follow-up. Subsequent attendance at the GP, but not at a hospital, was associated with risk level, but differences between centres could not be analysed. Satisfaction differed significantly between centres for 4 : 14 aspects of service provision and with 3 : 17 items concerning communication; satisfaction was high overall. Over 90% of referring doctors were moderately/very satisfied with the service, but 23% were dissatisfied with waiting times and 19% with access to preventive treatment. Results differed significantly between centres for doctor's satisfaction with the provision of referral criteria and prescribing information. In conclusion, there were relatively few significant differences in psychosocial outcomes between centres, considering the wide variation in service organisation and activity. These significant differences were not consistent across the centres, therefore, differences could not be linked to specific aspects of service provision.",2004,Satisfaction differed significantly between centres for 4 : 14 aspects of service provision and with 3 : 17 items concerning communication; satisfaction was high overall.,"['familial cancer', 'A total of 256 unaffected adults fulfilled the study criteria', '50 new clinic attendees, referred for cancer genetic counselling to five UK centres', 'unaffected attendees with a breast cancer risk (61-91%) than either a bowel cancer risk (0-33%) or ovarian cancer risk (3-25']",['UK genetic risk counselling services'],"['psychosocial outcomes', 'Questionnaires assessed demographic data, risk perception, mental health and use of health services pre-consultation', 'psychosocial data', 'cancer worry', 'Satisfaction', 'risk perception or general psychological distress']","[{'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0599986'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0346627', 'cui_str': 'Cancer of Intestines'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0542296', 'cui_str': 'Counselling service'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",256.0,0.0616553,Satisfaction differed significantly between centres for 4 : 14 aspects of service provision and with 3 : 17 items concerning communication; satisfaction was high overall.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hopwood', 'Affiliation': 'Christie Hospital NHS Trust, The CRC Psychological Medicine Group, Stanley House, Wilmslow Road, Withington, Manchester, M20 4BX, UK. penny.hopwood@christie-tr.nwest.nhs.uk'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wonderling', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Watson', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cull', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Douglas', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Cole', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Eccles', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gray', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Murday', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Steel', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Burn', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'McPherson', 'Affiliation': ''}]",British journal of cancer,[]
104,15558071,A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study.,"Docetaxel (75 mg m(-2) 3-weekly) is standard second-line treatment in advanced non-small-cell lung cancer (NSCLC) with significant toxicity. To verify whether a weekly schedule (33.3 mg m(-2) for 6 weeks) improved quality of life (QoL), a phase III study was performed with 220 advanced NSCLC patients, < or =75 years, ECOG PS < or =2. QoL was assessed by EORTC questionnaires and the Daily Diary Card (DDC). No difference was found in global QoL scores at 3 weeks. Pain, cough and hair loss significantly favoured the weekly schedule, while diarrhoea was worse. DDC analysis showed that loss of appetite and overall condition were significantly worse in the 3-week arm in the first week, while nausea and loss of appetite were more severe in the weekly arm in the third week. Response rate and survival were similar, hazard ratio of death in the weekly arm being 1.04 (95% CI 0.77-1.39). A 3-weekly docetaxel was more toxic for leukopenia, neutropenia, febrile neutropenia and hair loss; any grade 3-4 haematologic toxicity was significantly more frequent in the standard arm (25 vs 6%). The weekly schedule could be preferred for patients candidate to receive docetaxel as second-line treatment for advanced NSCLC, because of some QoL advantages, lower toxicity and no evidence of strikingly different effect on survival.",2004,"A 3-weekly docetaxel was more toxic for leukopenia, neutropenia, febrile neutropenia and hair loss; any grade 3-4 haematologic toxicity was significantly more frequent in the standard arm (25 vs 6%).","['non-small-cell lung cancer', '220 advanced NSCLC patients, < or =75 years, ECOG PS < or =2']","['docetaxel', 'Docetaxel']","['Pain, cough and hair loss', 'loss of appetite and overall condition', 'Response rate and survival', 'EORTC questionnaires and the Daily Diary Card (DDC', 'toxic for leukopenia, neutropenia, febrile neutropenia and hair loss; any grade 3-4 haematologic toxicity', 'global QoL scores', 'quality of life (QoL', 'hazard ratio of death', 'nausea and loss of appetite']","[{'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0012132', 'cui_str': 'Zalcitabine'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",220.0,0.0518552,"A 3-weekly docetaxel was more toxic for leukopenia, neutropenia, febrile neutropenia and hair loss; any grade 3-4 haematologic toxicity was significantly more frequent in the standard arm (25 vs 6%).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gridelli', 'Affiliation': 'Oncologia Medica, Azienda Ospedaliera S Giuseppe Moscati, Avellino, Italy. cgridelli@libero.it'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gallo', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Barletta', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Illiano', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Maione', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Salvagni', 'Affiliation': ''}, {'ForeName': 'F V', 'Initials': 'FV', 'LastName': 'Piantedosi', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Palazzolo', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Caffo', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ceribelli', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mazzanti', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Brancaccio', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Capuano', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Isa', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Barbera', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Perrone', 'Affiliation': ''}]",British journal of cancer,[]
105,15381932,A randomised phase II multicentre trial of irinotecan (CPT-11) using four different schedules in patients with metastatic colorectal cancer.,"The purpose of this phase II trial was to compare the efficacy, safety and pharmacokinetics of four irinotecan schedules for the treatment of metastatic colorectal cancer. In total, 174 5-fluorouracil pretreated patients were randomised to: arm A (n=41), 350 mg m(-2) irinotecan as a 90-min i.v. infusion q3 weeks; arm B (n=38), 125 mg m(-2) irinotecan as a 90-min i.v. infusion weekly x 4 weeks q6 weeks; arm C (n=46), 250 mg m(-2) irinotecan as a 90-min i.v. infusion q2 weeks; or arm D (n=49), 10 mg m(-2) day(-1) irinotecan as a 14-day continuous infusion q3 weeks. No significant differences in efficacy across the four arms were observed, although a shorter time to treatment failure was noted for arm D (1.7 months; P=0.02). Overall response rates were in the range 5-11%. Secondary end points included median survival (6.4-9.4 months), and time to progression (2.7-3.8 months) and treatment failure (1.7-3.2 months). Similarly, there were no significant differences in the incidence of grade 3-4 toxicities, although the toxicity profile between arms A, B, and C and D did differ. Generally, significantly less haematologic toxicity, alopecia and cholinergic syndrome were observed in arm D; however, there was a trend for increased gastrointestinal toxicity. Irinotecan is an effective and safe second-line treatment for colorectal cancer. The schedules examined yielded equivalent results, indicating that there is no advantage of the prolonged vs short infusion schedules.",2004,"No significant differences in efficacy across the four arms were observed, although a shorter time to treatment failure was noted for arm D (1.7 months; P=0.02).","['patients with metastatic colorectal cancer', 'metastatic colorectal cancer']","['5-fluorouracil', '350 mg m(-2) irinotecan', 'irinotecan (CPT-11', 'Irinotecan', 'irinotecan']","['median survival', 'efficacy', 'shorter time to treatment failure', 'treatment failure', 'efficacy, safety and pharmacokinetics', 'gastrointestinal toxicity', 'haematologic toxicity, alopecia and cholinergic syndrome', 'incidence of grade 3-4 toxicities', 'Overall response rates', 'toxicity profile', 'time to progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C4317169', 'cui_str': 'CPT-11'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0162643'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0274702', 'cui_str': 'Poisoning by parasympathomimetic drug'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.0370979,"No significant differences in efficacy across the four arms were observed, although a shorter time to treatment failure was noted for arm D (1.7 months; P=0.02).","[{'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Schoemaker', 'Affiliation': 'Antoni van Leeuwenhoek Hospital/The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'I E L M', 'Initials': 'IE', 'LastName': 'Kuppens', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Moiseyenko', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kjaer', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Starkhammer', 'Affiliation': ''}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Richel', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Smaaland', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bertelsen', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Poulsen', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Voznyi', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Norum', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fennelly', 'Affiliation': ''}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Tveit', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Garin', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gruia', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mourier', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sibaud', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lefebvre', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Beijnen', 'Affiliation': ''}, {'ForeName': 'J H M', 'Initials': 'JH', 'LastName': 'Schellens', 'Affiliation': ''}, {'ForeName': 'W W', 'Initials': 'WW', 'LastName': 'ten Bokkel Huinink', 'Affiliation': ''}]",British journal of cancer,[]
106,15381937,Phase II multicentre randomised study of docetaxel plus epirubicin vs 5-fluorouracil plus epirubicin and cyclophosphamide in metastatic breast cancer.,"The purpose of the study was to evaluate the efficacy and safety of docetaxel plus epirubicin (ET) and of 5-fluorouracil plus epirubicin and cyclophosphamide (FEC) as first-line chemotherapy for metastatic breast cancer. A total of 142 patients (intent-to-treat (ITT)) with at least one measurable lesion were randomised to receive docetaxel 75 mg m(-2) plus epirubicin 75 mg m(-2) or 5-fluorouracil 500 mg m(-2) plus epirubicin 75 mg m(-2) and cyclophosphamide 500 mg m(-2) intravenously once every 3 weeks for up to eight cycles. Prophylactic granulocyte-colony-stimulating factor was only permitted after the first cycle, if required. Per-protocol analysis (n=132) gave an overall response rate for ET of 63.1% (95% confidence interval (CI), 50-78%) and for FEC 34.3% (95% CI, 23-47%) after a median seven and six cycles, respectively. Intent-to-treat population (n=142) gave an overall response rate for ET of 59% (95% CI, 47-70%) and for FEC 32% (95% CI, 21-43%) after a median seven and six cycles, respectively. The median response duration for ET was 8.6 months (95% CI, 7.2-9.6 months) and for FEC 7.8 months (95% CI, 6.5-10.4 months). The median time to progression (ITT) for ET was 7.8 months (95% CI, 5.8-9.6 months) and for FEC 5.9 months (95% CI, 4.6-7.8 months). After a median follow-up of 23.8 months, median survival (ITT) for ET and FEC were 34 and 28 months, respectively. Nonhaematologic grade 3-4 toxicities were infrequent in both arms. Haematologic toxicity was more common with ET and febrile neutropenia was reported in 13 patients (18.6%) in the ET group. Two deaths in the ET group were possibly related to study treatment. In conclusion, both ET and FEC were associated with acceptable toxicity. ET is a highly active first-line therapy for metastatic breast cancer.",2004,Haematologic toxicity was more common with ET and febrile neutropenia was reported in 13 patients (18.6%) in the ET group.,"['142 patients (intent-to-treat (ITT)) with at least one measurable lesion', 'metastatic breast cancer']","['Prophylactic granulocyte-colony-stimulating factor', '5-fluorouracil plus epirubicin and cyclophosphamide (FEC', 'docetaxel plus epirubicin vs 5-fluorouracil plus epirubicin and cyclophosphamide', 'docetaxel 75 mg m(-2) plus epirubicin 75 mg m(-2) or 5-fluorouracil 500 mg m(-2) plus epirubicin 75 mg m(-2) and cyclophosphamide', 'docetaxel plus epirubicin (ET']","['febrile neutropenia', 'efficacy and safety', 'Nonhaematologic grade 3-4 toxicities', 'Haematologic toxicity', 'median time to progression (ITT', 'median survival (ITT', 'acceptable toxicity', 'overall response rate', 'median response duration for ET']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",142.0,0.057259,Haematologic toxicity was more common with ET and febrile neutropenia was reported in 13 patients (18.6%) in the ET group.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bonneterre', 'Affiliation': 'Centre Oscar Lambret, 3 rue Frédéric Combemale, 59020 Lille, France. j-bonneterre@o-lambret.fr'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Dieras', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tubiana-Hulin', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bougnoux', 'Affiliation': ''}, {'ForeName': 'M-E', 'Initials': 'ME', 'LastName': 'Bonneterre', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Delozier', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mayer', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Culine', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Dohoulou', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bendahmane', 'Affiliation': ''}]",British journal of cancer,[]
107,15238983,"Patient, carer and health service outcomes of nurse-led early discharge after breast cancer surgery: a randomised controlled trial.","Patients with breast cancer who require axillary clearance traditionally remain in hospital until their wound drains are removed. Early discharge has been shown to improve clinical outcomes, but there has been little assessment of the psychosocial and financial impact of early discharge on patients, carers and the health service. This study aimed to evaluate the effectiveness of a nurse-led model of early discharge from hospital. Main outcome measures were quality of life and carer burden. Secondary outcomes included patient satisfaction, arm morbidity, impact on community nurses, health service costs, surgical cancellations and in-patient nursing dependency. A total of 108 patients undergoing axillary clearance with mastectomy or wide local excision for breast cancer were randomised to nurse-led early discharge or conventional stay. Nurse-led early discharge had no adverse effects on quality of life or patient satisfaction, had little effect on carer burden, improved communication between primary and secondary care, reduced cancellations and was safely implemented in a mixed rural/urban setting. In total, 40% of eligible patients agreed to take part. Nonparticipants were significantly older, more likely to live alone and had lower emotional well being before surgery. This study provides further evidence of the benefits of early discharge from hospital following axillary clearance for breast cancer. However, if given the choice, most patients prefer to stay in hospital until their wound drains are removed.",2004,"Nurse-led early discharge had no adverse effects on quality of life or patient satisfaction, had little effect on carer burden, improved communication between primary and secondary care, reduced cancellations and was safely implemented in a mixed rural/urban setting.","['Patients with breast cancer who require axillary clearance traditionally remain in hospital until their wound drains are removed', 'breast cancer', '108 patients undergoing axillary clearance with mastectomy or wide local excision for breast cancer']","['nurse-led early discharge after breast cancer surgery', 'nurse-led early discharge or conventional stay']","['quality of life or patient satisfaction', 'quality of life and carer burden', 'patient satisfaction, arm morbidity, impact on community nurses, health service costs, surgical cancellations and in-patient nursing dependency']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4087394', 'cui_str': 'Axillary clearance'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0180503', 'cui_str': 'Wound drain (physical object)'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0278259', 'cui_str': 'Local resection'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0557521', 'cui_str': 'Community nurse (occupation)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}]",108.0,0.286091,"Nurse-led early discharge had no adverse effects on quality of life or patient satisfaction, had little effect on carer burden, improved communication between primary and secondary care, reduced cancellations and was safely implemented in a mixed rural/urban setting.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wells', 'Affiliation': 'School of Nursing and Midwifery, University of Dundee, Dundee DD1 4HJ, UK. m.z.wells@dundee.ac.uk'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Harrow', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Donnan', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Davey', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Devereux', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Little', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'McKenna', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wood', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': ''}]",British journal of cancer,[]
108,15238986,"Irinotecan plus gemcitabine vs irinotecan for the second-line treatment of patients with advanced non-small-cell lung cancer pretreated with docetaxel and cisplatin: a multicentre, randomised, phase II study.","To compare irinotecan (CPT-11)+gemcitabine vs CPT-11 alone as second-line treatment for patients with advanced non-small cell lung cancer (NSCLC) progressing after docetaxel-cisplatinum-based therapy. A total of 147 evaluable, pretreated patients, with NSCLC, received either gemcitabine (1000 mg m(-2), days 1 and 8)+CPT-11 (300 mg m(-2), day 8) (Group A, n=76) or CPT-11 (300 mg m(-2), day 1) (Group B, n=71), every 3 weeks. All patients were evaluable for response and toxicity. The objective response rate was 18.4% (95% CI: 9.71-27.14%) and 4.2% (95% CI: 0-8.90%) (P=0.009) for groups A and B, respectively. No significant differences between the two groups in terms of the median duration of response, time to tumour progression, overall survival and 1-year survival were observed. The CPT-11/gemcitabine regimen significantly improved the patients' quality of life ('general mood today' (P=0.014), 'coughing' (P=0.003) and 'intensity of symptoms' (P=0.034)) compared with CPT-11. More cycles had to be delayed (P=0.001) and required prophylactic growth factor support (P=0.001) in Group A than B. Three (3.9%) patients in Group A and eight (11.3%) in Group B developed febrile neutropenia (P=0.09); one patient died of sepsis in each group. Three additional (Group A, n=1; Group B, n=2) treatment-related deaths were observed. Grade 3-4 haematologic toxicity was comparable in the two groups except anaemia (P=0.03 in favour of CPT-11). Other nonhaematologic toxicities were mild and similar in the two groups. CPT-11+gemcitabine resulted in a higher response rate and better control of disease-related symptoms than CPT-11 alone, but without any improvement in the overall survival.",2004,"CPT-11+gemcitabine resulted in a higher response rate and better control of disease-related symptoms than CPT-11 alone, but without any improvement in the overall survival.","['A total of 147 evaluable, pretreated patients, with NSCLC', 'patients with advanced non-small-cell lung cancer pretreated with', 'patients with advanced non-small cell lung cancer (NSCLC) progressing after']","['gemcitabine', '8)+CPT-11', 'CPT-11/gemcitabine', 'Irinotecan plus gemcitabine vs irinotecan', 'CPT-11', 'irinotecan (CPT-11)+gemcitabine vs CPT-11 alone', 'CPT-11+gemcitabine', 'docetaxel-cisplatinum-based therapy', 'docetaxel and cisplatin']","['median duration of response, time to tumour progression, overall survival and 1-year survival', 'objective response rate', 'febrile neutropenia', 'response and toxicity', 'nonhaematologic toxicities', 'response rate and better control of disease-related symptoms', 'overall survival', 'patient died of sepsis', 'anaemia', 'Grade 3-4 haematologic toxicity', 'intensity of symptoms', ""patients' quality of life ('general mood today"", 'prophylactic growth factor support', 'coughing']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C4317169', 'cui_str': 'CPT-11'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1306577', 'cui_str': 'On examination - dead (finding)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}]",,0.0788286,"CPT-11+gemcitabine resulted in a higher response rate and better control of disease-related symptoms than CPT-11 alone, but without any improvement in the overall survival.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Georgoulias', 'Affiliation': 'Department of Medical Oncology, University General Hospital of Heraklion, Greece. georgoul@med.uoc.gr'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kouroussis', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Agelidou', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Boukovinas', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Palamidas', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stavrinidis', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Polyzos', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Syrigos', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Veslemes', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Toubis', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ardavanis', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tselepatiotis', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vlachonikolis', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of cancer,[]
109,28394087,Epigenome-wide Association of DNA Methylation in Whole Blood With Bone Mineral Density.,"Genetic and environmental determinants of skeletal phenotypes such as bone mineral density (BMD) may converge through the epigenome, providing a tool to better understand osteoporosis pathophysiology. Because the epigenetics of BMD have been largely unexplored in humans, we performed an epigenome-wide association study (EWAS) of BMD. We undertook a large-scale BMD EWAS using the Infinium HumanMethylation450 array to measure site-specific DNA methylation in up to 5515 European-descent individuals (N Discovery   = 4614, N Validation   = 901). We associated methylation at multiple cytosine-phosphate-guanine (CpG) sites with dual-energy X-ray absorptiometry (DXA)-derived femoral neck and lumbar spine BMD. We performed sex-combined and stratified analyses, controlling for age, weight, smoking status, estimated white blood cell proportions, and random effects for relatedness and batch effects. A 5% false-discovery rate was used to identify CpGs associated with BMD. We identified one CpG site, cg23196985, significantly associated with femoral neck BMD in 3232 females (p = 7.9 × 10 -11  ) and 4614 females and males (p = 3.0 × 10 -8  ). cg23196985 was not associated with femoral neck BMD in an additional sample of 474 females (p = 0.64) and 901 males and females (p = 0.60). Lack of strong consistent association signal indicates that among the tested probes, no large-effect epigenetic changes in whole blood associated with BMD, suggesting future epigenomic studies of musculoskeletal traits measure DNA methylation in a different tissue with extended genome coverage. © 2017 American Society for Bone and Mineral Research.",2017,"We identified one CpG site, cg23196985, significantly associated with femoral neck BMD in 3232 females (p = 7.9 ","['up to 5515 European-descent individuals (N Discovery\u2009  =\u20094614, N Validation\u2009  =\u2009901', '4614 females and males (p\u2009=\u20093.0\u2009×\u200910 -8  ', '3232 females (p\u2009=\u20097.9', '© 2017 American Society for Bone and Mineral Research']",['cytosine-phosphate-guanine (CpG) sites with dual-energy X-ray absorptiometry'],['femoral neck BMD'],"[{'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0035168'}]","[{'cui': 'C0010843', 'cui_str': 'Cytosine'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0018321', 'cui_str': 'Guanine'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]","[{'cui': 'C0015815', 'cui_str': 'Femoral Neck'}]",,0.0203786,"We identified one CpG site, cg23196985, significantly associated with femoral neck BMD in 3232 females (p = 7.9 ","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Morris', 'Affiliation': 'Department of Human Genetics, McGill University, Montreal, Canada.'}, {'ForeName': 'Pei-Chien', 'Initials': 'PC', 'LastName': 'Tsai', 'Affiliation': ""Department of Twin Research and Genetic Epidemiology, King's College London, London, UK.""}, {'ForeName': 'Roby', 'Initials': 'R', 'LastName': 'Joehanes', 'Affiliation': 'Institute for Aging Research, Hebrew SeniorLife, Boston, MA, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'MRC Integrative Epidemiology Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Trajanoska', 'Affiliation': 'Departments of Internal Medicine and Epidemiology, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Soerensen', 'Affiliation': 'The Danish Twin Registry and The Danish Aging Research Center, Epidemiology, Biostatistics, and Biodemography, Institute of Public Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Forgetta', 'Affiliation': 'Lady Davis Institute for Medical Research, Department of Medicine, Jewish General Hospital, McGill University, Montreal, Canada.'}, {'ForeName': 'Juan Edgar', 'Initials': 'JE', 'LastName': 'Castillo-Fernandez', 'Affiliation': ""Department of Twin Research and Genetic Epidemiology, King's College London, London, UK.""}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Frost', 'Affiliation': 'Endocrine Research Unit, KMEB, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Tim D', 'Initials': 'TD', 'LastName': 'Spector', 'Affiliation': ""Department of Twin Research and Genetic Epidemiology, King's College London, London, UK.""}, {'ForeName': 'Kaare', 'Initials': 'K', 'LastName': 'Christensen', 'Affiliation': 'The Danish Twin Registry and The Danish Aging Research Center, Epidemiology, Biostatistics, and Biodemography, Institute of Public Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Christiansen', 'Affiliation': 'The Danish Twin Registry and The Danish Aging Research Center, Epidemiology, Biostatistics, and Biodemography, Institute of Public Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rivadeneira', 'Affiliation': 'Departments of Internal Medicine and Epidemiology, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Tobias', 'Affiliation': 'MRC Integrative Epidemiology Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Evans', 'Affiliation': 'MRC Integrative Epidemiology Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Douglas P', 'Initials': 'DP', 'LastName': 'Kiel', 'Affiliation': 'Institute for Aging Research, Hebrew SeniorLife, Boston, MA, USA.'}, {'ForeName': 'Yi-Hsiang', 'Initials': 'YH', 'LastName': 'Hsu', 'Affiliation': 'Institute for Aging Research, Hebrew SeniorLife, Boston, MA, USA.'}, {'ForeName': 'J Brent', 'Initials': 'JB', 'LastName': 'Richards', 'Affiliation': 'Department of Human Genetics, McGill University, Montreal, Canada.'}, {'ForeName': 'Jordana T', 'Initials': 'JT', 'LastName': 'Bell', 'Affiliation': ""Department of Twin Research and Genetic Epidemiology, King's College London, London, UK.""}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3148']
110,16108933,Effect of blood pressure and diabetes mellitus on cognitive and physical functions in older adults: a longitudinal analysis of the advanced cognitive training for independent and vital elderly cohort.,"OBJECTIVES


To evaluate the effect of blood pressure (BP) and diabetes mellitus (DM) on cognitive and physical performance in older, independent-living adults.
DESIGN


Longitudinal study with secondary data analysis from the Advanced Cognitive Training for Independent and Vital Elderly randomized intervention trial.
SETTING


Six field sites in the United States.
PARTICIPANTS


Two thousand eight hundred two independent-living subjects aged 65 to 94.
MEASUREMENTS


Cognitive functions in different domains and physical functions measured using activities of daily living, instrumental activities of daily living (IADLs), and the physical function subscale from the Medical Outcomes Study Short Form-36 (SF-36) Health Survey.
RESULTS


After the first annual examination, hypertension was associated with a faster decline in performance on logical reasoning tasks (ability to solve problems following a serial pattern), whereas DM was associated with accelerated decline on the Digit Symbol Substitution Test (speed of processing). The reasoning and Digit Symbol Substitution test are executive function tasks thought to be related to frontal-lobe function. Hypertension and DM were associated with a significantly faster pace of decline on the SF-36 physical function component score. Individuals with DM had a faster pace of decline in IADL functioning than nondiabetic subjects. There was no evidence for an interaction between BP and DM on cognitive or physical function decline.
CONCLUSION


Hypertension and DM are associated with accelerated decline in executive measures and physical function in independent-living elderly subjects. Further research is needed to determine whether cardiovascular risk modification ameliorates cognitive and functional decline in elderly people.",2005,"After the first annual examination, hypertension was associated with a faster decline in performance on logical reasoning tasks (ability to solve problems following a serial pattern), whereas DM was associated with accelerated decline on the Digit Symbol Substitution Test (speed of processing).","['Six field sites in the United States', 'older, independent-living adults', 'older adults', 'Two thousand eight hundred two independent-living subjects aged 65 to 94', 'elderly people']","['Advanced Cognitive Training', 'advanced cognitive training', 'blood pressure and diabetes mellitus', 'blood pressure (BP) and diabetes mellitus (DM']","['SF-36 physical function component score', 'IADL functioning', 'Hypertension and DM', 'cognitive or physical function decline', 'cognitive and physical performance', 'Digit Symbol Substitution Test (speed of processing', 'cognitive and physical functions', 'executive measures and physical function', 'Cognitive functions in different domains and physical functions measured using activities of daily living, instrumental activities of daily living (IADLs), and the physical function subscale from the Medical Outcomes Study Short Form-36 (SF-36) Health Survey']","[{'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021189', 'cui_str': 'Independent Living'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517680', 'cui_str': 'Two thousand eight hundred'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2607857'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",,0.051766,"After the first annual examination, hypertension was associated with a faster decline in performance on logical reasoning tasks (ability to solve problems following a serial pattern), whereas DM was associated with accelerated decline on the Digit Symbol Substitution Test (speed of processing).","[{'ForeName': 'Hsu-Ko', 'Initials': 'HK', 'LastName': 'Kuo', 'Affiliation': 'Division on Aging, Harvard Medical School, Boston, Massachusetts 02131, USA.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Milberg', 'Affiliation': ''}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Tennstedt', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Talbot', 'Affiliation': ''}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': ''}]",Journal of the American Geriatrics Society,[]
111,15545973,Quantifying trade-offs: quality of life and quality-adjusted survival in a randomised trial of chemotherapy in postmenopausal patients with lymph node-negative breast cancer.,"We evaluated quality of life (QL) and quality-adjusted survival in International Breast Cancer Study Group Trial IX, a randomised trial including 1669 eligible patients receiving tamoxifen for 5 years or three prior cycles of cyclophosphamide, methotrexate and 5-fluorouracil (CMF) followed by 57 months tamoxifen. During the time with CMF toxicity (Tox), without symptoms and toxicity (TWiST), and following relapse (Rel), patients scored their QL indicators and a utility indicator for subjective health estimation between 'perfect' and 'worst' health. Scores were averaged within Tox, TWiST and Rel and transformed to utilities. Mean durations for the three transition times were weighted with utilities to obtain mean quality-adjusted TWiST (Q-TWiST). Patients receiving CMF reported significantly worse scores for most QL domains at month 3, but less hot flushes. After completing chemotherapy, there were no differences by treatment groups. Benefits evaluated by Q-TWiST favoured the additional chemotherapy. CMF provided 3 more months of Q-TWiST for patients with ER-negative tumours, but CMF provided no benefit in Q-TWiST for patients with ER-positive tumours. Q-TWiST analysis based on patient ratings is feasible in large-scale cross-cultural clinical trials.",2004,"Patients receiving CMF reported significantly worse scores for most QL domains at month 3, but less hot flushes.","['1669 eligible patients receiving', 'for 5 years or three prior cycles of', 'postmenopausal patients with lymph node-negative breast cancer']","['cyclophosphamide, methotrexate and 5-fluorouracil (CMF) followed by 57 months tamoxifen', 'tamoxifen', 'CMF', 'chemotherapy', 'Q-TWiST']","['Mean durations', 'life and quality-adjusted survival', 'quality of life (QL) and quality-adjusted survival', 'CMF toxicity (Tox), without symptoms and toxicity (TWiST), and following relapse (Rel']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0040480', 'cui_str': 'Musculoskeletal torsion (observable entity)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0034380'}, {'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",1669.0,0.0557003,"Patients receiving CMF reported significantly worse scores for most QL domains at month 3, but less hot flushes.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bernhard', 'Affiliation': 'IBCSG Coordinating Center, Bern, Switzerland. juerg.bernhard@ibcsg.org'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Zahrieh', 'Affiliation': ''}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': ''}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Castiglione-Gertsch', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Murray', 'Affiliation': ''}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Forbes', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Perey', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Snyder', 'Affiliation': ''}, {'ForeName': 'C-M', 'Initials': 'CM', 'LastName': 'Rudenstam', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Crivellari', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Veronesi', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thürlimann', 'Affiliation': ''}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Fey', 'Affiliation': ''}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Price', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hürny', 'Affiliation': ''}]",British journal of cancer,[]
112,15266334,Gemcitabine with either paclitaxel or vinorelbine vs paclitaxel or gemcitabine alone for elderly or unfit advanced non-small-cell lung cancer patients.,"The aim of this study was to assess whether a combination of gemcitabine (GEM) with either paclitaxel (PTX) or vinorelbine (VNR) could be more effective than GEM or PTX alone in elderly or unfit advanced non-small-cell lung cancer (NSCLC) patients. A total of 264 NSCLC patients aged >70 years with ECOG performance status (PS)< or =2, or younger with PS=2, were randomly treated with: GEM 1200 mg m(-2) on days 1, 8 and 15 every 28 days; PTX 100 mg m(-2) on days 1, 8 and 15 every 28 days; GEM 1000 mg m(-2) plus PTX 80 mg m(-2) (GT) on days 1 and 8 every 21 days; GEM 1000 mg m(-2) plus VNR 25 mg m(-2) (GV) on days 1 and 8 every 21 days. In all arms, an intra-patients dose escalation was applied over the first three courses, provided that no toxicity of WHO grade > or =2 had previously occurred. At present time, 217 (82%) patients had died. The median (months) and 1-year survival probability were 5.1 and 29% for GEM, 6.4 and 25% for PTX, 9.2 and 44% for GT, and 9.7 and 32% for GV. Multivariate analysis showed that PS< or =1 (hazard ratio (HR)=0.67; 95% CI 0.51-0.90), and doublet treatments (HR=0.76; 95% CI 0.59-0.99) were significantly associated with longer survival. Doublets produced no more toxicity than single agents. GT should be considered a reference regimen for elderly NSCLC patients with PS< or =1.",2004,"Multivariate analysis showed that PS< or =1 (hazard ratio (HR)=0.67; 95% CI 0.51-0.90), and doublet treatments (HR=0.76; 95% CI 0.59-0.99) were significantly associated with longer survival.","['264 NSCLC patients aged >70 years with ECOG performance status (PS)< or =2, or younger with PS=2', 'elderly or unfit advanced non-small-cell lung cancer (NSCLC) patients', 'elderly NSCLC patients with PS< or =1', 'elderly or unfit advanced non-small-cell lung cancer patients']","['paclitaxel or vinorelbine vs paclitaxel or gemcitabine alone', 'GEM 1000 mg m(-2) plus PTX', 'Gemcitabine', 'GEM', 'GEM 1000 mg m(-2) plus VNR 25 mg m(-2) (GV', 'gemcitabine (GEM) with either paclitaxel (PTX) or vinorelbine (VNR', 'GEM or PTX alone']","['longer survival', 'toxicity', 'died', '1-year survival probability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0445501', 'cui_str': 'Gem (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",264.0,0.0702681,"Multivariate analysis showed that PS< or =1 (hazard ratio (HR)=0.67; 95% CI 0.51-0.90), and doublet treatments (HR=0.76; 95% CI 0.59-0.99) were significantly associated with longer survival.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Comella', 'Affiliation': 'Division of Medical Oncology A, Department of Medicine, National Tumour Institute, Via M. Semmola, 80131 Naples, Italy. pasqualecornella@libero.it'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Frasci', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Carnicelli', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Massidda', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Buzzi', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Filippelli', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Maiorino', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Guida', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Panza', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mancarella', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cioffi', 'Affiliation': ''}]",British journal of cancer,[]
113,15266329,Tamoxifen treatment reverses the adverse effects of chemotherapy-induced ovarian failure on serum lipids.,"In all, 146 premenopausal women with early stage breast cancer were treated with adjuvant chemotherapy. In addition, 5-year tamoxifen treatment was started after chemotherapy to those 112 patients with hormone-receptor-positive tumours while those with hormone-receptor-negative tumours received no further therapy. The serum lipid levels were followed in both groups. The levels of serum total and low-density lipoprotein (LDL) cholesterol increased significantly after chemotherapy only in patients who developed ovarian dysfunction. Total cholesterol increased +9.5% and LDL cholesterol +16.6% in patients who developed amenorrhoea (P<0.00001 and 0.00001, respectively). The cholesterol levels did not change in patients who preserved regular menstruation after chemotherapy. After 6 months of tamoxifen therapy, the total cholesterol decreased -9.7% and the LDL cholesterol -16.7% from levels after the chemotherapy, while the cholesterol concentrations remained at increased levels in the control group (P=0.001 and P<0.0001, respectively). The high-density lipoprotein cholesterol levels did not change significantly in either tamoxifen or control group. The effects of tamoxifen treatment on serum lipids after chemotherapy have not been studied before. Our current study suggests that adjuvant tamoxifen therapy reverses the adverse effects of chemotherapy-induced ovarian failure on total and LDL cholesterol and even lowers their serum levels below the baseline.",2004,The levels of serum total and low-density lipoprotein (LDL) cholesterol increased significantly after chemotherapy only in patients who developed ovarian dysfunction.,"['146 premenopausal women with early stage breast cancer', '112 patients with hormone-receptor-positive tumours']","['adjuvant chemotherapy', 'Tamoxifen', 'tamoxifen therapy', 'tamoxifen']","['Total cholesterol', 'cholesterol concentrations', 'total cholesterol', 'serum lipid levels', 'levels of serum total and low-density lipoprotein (LDL) cholesterol', 'LDL cholesterol', 'total and LDL cholesterol', 'high-density lipoprotein cholesterol levels', 'adverse effects', 'serum lipids', 'cholesterol levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1563119', 'cui_str': 'Hormone receptor positive tumor'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C4510392', 'cui_str': 'Tamoxifen therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1287373', 'cui_str': 'Finding of serum lipid levels (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}]",146.0,0.10924,The levels of serum total and low-density lipoprotein (LDL) cholesterol increased significantly after chemotherapy only in patients who developed ovarian dysfunction.,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vehmanen', 'Affiliation': 'Department of Oncology, Helsinki University Central Hospital, PO BOX 180, HUCH, FIN-00290, Helsinki, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Saarto', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Blomqvist', 'Affiliation': ''}, {'ForeName': 'M-R', 'Initials': 'MR', 'LastName': 'Taskinen', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Elomaa', 'Affiliation': ''}]",British journal of cancer,[]
114,15199394,A randomised trial of single-dose radiotherapy to prevent procedure tract metastasis by malignant mesothelioma.,"A single 9-MeV electron treatment, following invasive thoracic procedures in patients with malignant pleural mesothelioma, was examined. In all, 58 sites were randomised to prophylactic radiotherapy or not. There was no statistically significant difference in tract metastasis. A single 10-Gy treatment with 9-MeV electrons appears ineffective.",2004,"A single 9-MeV electron treatment, following invasive thoracic procedures in patients with malignant pleural mesothelioma, was examined.","['patients with malignant pleural mesothelioma', 'procedure tract metastasis by malignant mesothelioma']","['prophylactic radiotherapy', 'single-dose radiotherapy']",['tract metastasis'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura (disorder)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0345967', 'cui_str': 'Mesothelioma, malignant (morphologic abnormality)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}]",58.0,0.0695149,"A single 9-MeV electron treatment, following invasive thoracic procedures in patients with malignant pleural mesothelioma, was examined.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bydder', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Hospital Avenue, Perth, Nedlands, WA 6009, Australia. sean.bydder@health.wa.gov.au'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Phillips', 'Affiliation': ''}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cameron', 'Affiliation': ''}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Spry', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'DeMelker', 'Affiliation': ''}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Musk', 'Affiliation': ''}]",British journal of cancer,[]
115,19531608,Comparison of bilateral and unilateral training for upper extremity hemiparesis in stroke.,"BACKGROUND


Upper extremity hemiparesis is the most common poststroke disability. Longitudinal studies have indicated that 30% to 66% of stroke survivors do not have full arm function 6 months poststroke. One promising treatment approach is bilateral training. To date, no randomized, blinded study of efficacy comparing 2 groups (bilateral training vs unilateral training) using analogous tasks has been performed in chronic stroke survivors with moderate upper extremity impairment.
OBJECTIVE


To compare the effectiveness of bilateral training with unilateral training for individuals with moderate upper limb hemiparesis. The authors hypothesized that bilateral training would be superior to unilateral training in the proximal extremity but not the distal one.
METHODS


Twenty-four subjects participated in a randomized, single-blind training study. Subjects in the bilateral group (n = 12) practiced bilateral symmetrical activities, whereas the unilateral group (n = 12) performed the same activity with the affected arm only. The activities consisted of reaching-based tasks that were both rhythmic and discrete. The Motor Assessment Scale (MAS), Motor Status Scale (MSS), and muscle strength were used as outcome measures. Assessments were administered at baseline and posttraining by a rater blinded to group assignment.
RESULTS


Both groups had significant improvements on the MSS and measures of strength. The bilateral group had significantly greater improvement on the Upper Arm Function scale (a subscale of the MAS-Upper Limb Items).
CONCLUSION


Both bilateral and unilateral training are efficacious for moderately impaired chronic stroke survivors. Bilateral training may be more advantageous for proximal arm function.",2009,"The bilateral group had significantly greater improvement on the Upper Arm Function scale (a subscale of the MAS-Upper Limb Items).
","['chronic stroke survivors with moderate upper extremity impairment', 'Twenty-four subjects participated', 'individuals with moderate upper limb hemiparesis', 'upper extremity hemiparesis in stroke']","['Bilateral training', '2 groups (bilateral training vs unilateral training', 'bilateral and unilateral training', 'bilateral training with unilateral training', 'bilateral training']","['bilateral symmetrical activities', 'Motor Assessment Scale (MAS), Motor Status Scale (MSS), and muscle strength', 'Upper Arm Function scale', 'MSS and measures of strength']","[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0457436', 'cui_str': 'Left hemiparesis (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0451321', 'cui_str': 'Motor assessment scale (assessment scale)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0446516', 'cui_str': 'Brachiums'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",24.0,0.0260177,"The bilateral group had significantly greater improvement on the Upper Arm Function scale (a subscale of the MAS-Upper Limb Items).
","[{'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Stoykov', 'Affiliation': 'Sensorimotor Performance Program, Rehabilitation Institute of Chicago, Chicago, Illinois, USA. mphillips@ric.org'}, {'ForeName': 'Gwyn N', 'Initials': 'GN', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Corcos', 'Affiliation': ''}]",Neurorehabilitation and neural repair,['10.1177/1545968309338190']
116,32431856,Does repeatedly viewing overweight versus underweight images change perception of and satisfaction with own body size?,"Body dissatisfaction is associated with subsequent eating disorders and weight gain. One-off exposure to bodies of different sizes changes perception of others' bodies, and perception of and satisfaction with own body size. The effect of repeated exposure to bodies of different sizes has not been assessed. We randomized women into three groups, and they spent 5 min twice a day for a week completing a one-back task using images of women modified to appear either under, over, or neither over- nor underweight. We tested the effects on their perception of their own and others' body size, and satisfaction with own size. Measures at follow-up were compared between groups, adjusted for baseline measurements. In 93 women aged 18-30 years, images of other women were perceived as larger following exposure to underweight women (and vice versa) ( p  < 0.001). There was no evidence for a difference in our primary outcome measure (visual analogue scale own size) or in satisfaction with own size. Avatar-constructed ideal ( p  = 0.03) and avatar-constructed perceived own body size ( p  = 0.007) both decreased following exposure to underweight women, possibly due to adaptation affecting how the avatar was perceived. Repeated exposure to different sized bodies changes perception of the size of others' bodies, but we did not find evidence that it changes perceived own size.",2020,"In 93 women aged 18-30 years, images of other women were perceived as larger following exposure to underweight women (and vice versa) ( p  < 0.001).",['93 women aged 18-30 years'],[],['visual analogue scale own size) or in satisfaction with own size'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",93.0,0.0645557,"In 93 women aged 18-30 years, images of other women were perceived as larger following exposure to underweight women (and vice versa) ( p  < 0.001).","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Bould', 'Affiliation': 'Centre for Academic Mental Health, Population Health Sciences, University of Bristol, Oakfield House, Oakfield Grove, Bristol BS8 2BN, UK.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Noonan', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Warneford Lane, Oxford OX3 7JX, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Penton-Voak', 'Affiliation': 'MRC Integrative Epidemiology Unit, University of Bristol, Oakfield House, Oakfield Grove, Bristol BS8 2BN, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Skinner', 'Affiliation': 'MRC Integrative Epidemiology Unit, University of Bristol, Oakfield House, Oakfield Grove, Bristol BS8 2BN, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, School of Psychological Science, University of Bristol, 12a Priory Road, Clifton, Bristol BS8 1TU, UK.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Warneford Lane, Oxford OX3 7JX, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Broome', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Warneford Lane, Oxford OX3 7JX, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Warneford Lane, Oxford OX3 7JX, UK.'}]",Royal Society open science,['10.1098/rsos.190704']
117,31522845,Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): an open-label randomised controlled trial.,"BACKGROUND


Despite increasing worldwide use of anti-vascular endothelial growth factor agents for treatment of retinopathy of prematurity (ROP), there are few data on their ocular efficacy, the appropriate drug and dose, the need for retreatment, and the possibility of long-term systemic effects. We evaluated the efficacy and safety of intravitreal ranibizumab compared with laser therapy in treatment of ROP.
METHODS


This randomised, open-label, superiority multicentre, three-arm, parallel group trial was done in 87 neonatal and ophthalmic centres in 26 countries. We screened infants with birthweight less than 1500 g who met criteria for treatment for retinopathy, and randomised patients equally (1:1:1) to receive a single bilateral intravitreal dose of ranibizumab 0·2 mg or ranibizumab 0·1 mg, or laser therapy. Individuals were stratified by disease zone and geographical region using computer interactive response technology. The primary outcome was survival with no active retinopathy, no unfavourable structural outcomes, or need for a different treatment modality at or before 24 weeks (two-sided α=0·05 for superiority of ranibizumab 0·2 mg against laser therapy). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT02375971.
INTERPRETATION


Between Dec 31, 2015, and June 29, 2017, 225 participants (ranibizumab 0·2 mg n=74, ranibizumab 0·1 mg n=77, laser therapy n=74) were randomly assigned. Seven were withdrawn before treatment (n=1, n=1, n=5, respectively) and 17 did not complete follow-up to 24 weeks, including four deaths in each group. 214 infants were assessed for the primary outcome (n=70, n=76, n=68, respectively). Treatment success occurred in 56 (80%) of 70 infants receiving ranibizumab 0·2 mg compared with 57 (75%) of 76 infants receiving ranibizumab 0·1 mg and 45 (66%) of 68 infants after laser therapy. Using a hierarchical testing strategy, compared with laser therapy the odds ratio (OR) of treatment success following ranibizumab 0·2 mg was 2·19 (95% Cl 0·99-4·82, p=0·051), and following ranibizumab 0·1 mg was 1·57 (95% Cl 0·76-3·26); for ranibizumab 0·2 mg compared with 0·1 mg the OR was 1·35 (95% Cl 0·61-2·98). One infant had an unfavourable structural outcome following ranibizumab 0·2 mg, compared with five following ranibizumab 0·1 mg and seven after laser therapy. Death, serious and non-serious systemic adverse events, and ocular adverse events were evenly distributed between the three groups.
FINDINGS


In the treatment of ROP, ranibizumab 0·2 mg might be superior to laser therapy, with fewer unfavourable ocular outcomes than laser therapy and with an acceptable 24-week safety profile.
FUNDING


Novartis.",2019,Treatment success occurred in 56 (80%) of 70 infants receiving ranibizumab 0·2 mg compared with 57 (75%) of 76 infants receiving ranibizumab 0·1 mg and 45 (66%) of 68 infants after laser therapy.,"['225 participants ', '0·1 mg n=77, laser therapy n=74', 'screened infants with birthweight less than 1500 g who met criteria for treatment for retinopathy, and randomised patients equally (1:1:1', 'very low birthweight infants with retinopathy of prematurity (RAINBOW', '214 infants were assessed for the primary outcome (n=70, n=76, n=68, respectively', '87 neonatal and ophthalmic centres in 26 countries']","['ranibizumab', 'ROP, ranibizumab', 'Ranibizumab', 'ranibizumab 0·2 mg n=74, ranibizumab', 'laser therapy', 'ranibizumab 0·2 mg or ranibizumab 0·1 mg, or laser therapy', 'intravitreal ranibizumab']","['Treatment success', 'efficacy and safety', 'Death, serious and non-serious systemic adverse events, and ocular adverse events', 'survival with no active retinopathy, no unfavourable structural outcomes, or need for a different treatment modality']","[{'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035309', 'cui_str': 'Retinal Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0035309', 'cui_str': 'Retinal Diseases'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}]",225.0,0.377076,Treatment success occurred in 56 (80%) of 70 infants receiving ranibizumab 0·2 mg compared with 57 (75%) of 76 infants receiving ranibizumab 0·1 mg and 45 (66%) of 68 infants after laser therapy.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stahl', 'Affiliation': 'Department of Ophthalmology, University Medical Center, Greifswald, Germany.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Lepore', 'Affiliation': 'Department of Ophthalmology, Gemelli Foundation IRCSS, Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Fielder', 'Affiliation': 'Department of Optometry and Visual Science, City, University of London, London, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Fleck', 'Affiliation': 'Royal Hospital for Sick Children, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Reynolds', 'Affiliation': 'Ross Eye Institute, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Chiang', 'Affiliation': 'Casey Eye Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Liew', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Maier', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'China Novartis Institutes for BioMedical Research Company, Shanghai, China.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Marlow', 'Affiliation': ""Academic Neonatology, UCL Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK. Electronic address: n.marlow@ucl.ac.uk.""}]","Lancet (London, England)",['10.1016/S0140-6736(19)31344-3']
118,15292922,A phase I/II study of gemcitabine and fractionated cisplatin in an outpatient setting using a 21-day schedule in patients with advanced and metastatic bladder cancer.,"A randomised phase III trial of MVAC (methotrexate, vincristine, doxorubicin, cisplatin) vs gemcitabine and cisplatin (GC) (G 1000 mg m(-2) days 1, 8, and 15 plus C 70 mg m(-2) day 2, q 4 wks) indicated GC had similar efficacy and lower toxicity (JCO 2000). Significant haematologic toxicities in the GC arm occurred on day 15, necessitating dose adjustments in 37% of cycles. We conducted a phase I/II dose escalation trial using GC on a 21-day cycle, with G and C split between days 1 and 8. The objective of the study to define maximum-tolerated dose and dose-limiting toxicity (DLT), objective response rate, and overall survival. In all, 32 patients with locally advanced, relapsed, or metastatic disease received: dose level 1, G/C 1000/35; level 2, 1100/35; level 3, 1200/35; level 4, 1200/45 mg m(-2) (G and C given on days 1 and 8 every 3 wks). A total of 19 patients had glomerular filtration rate <60 ml min(-1) and 19 patients had metastatic disease. Dose-limiting toxicity was haematologic (grade 4 thrombocytopenia) at dose level 2. Of 151 cycles, at day 15, platelets were <100 in 61 cycles; neutrophils <0.5, platelets <50 in 26 cycles. Only seven cycles were deferred due to haematological toxicity; four for renal toxicity (chemotherapy instituted posthydration). Overall response rate was 65.5% on an intention-to-treat analysis (75% [21/28] for assessable patients), with four complete responses (12.5%) and 17 partial responses (53%). After the median follow-up of 17.2 months (range 13.1-32.4 months), 12 patients remain alive. The overall median survival was 16 months (range 10.1-26.6 months). G plus C every 3 weeks is active and well tolerated in an outpatient setting, even in patients receiving prior platinum-based regimens and with poor renal reserve.",2004,"Overall response rate was 65.5% on an intention-to-treat analysis (75% [21/28] for assessable patients), with four complete responses (12.5%) and 17 partial responses (53%).","['32 patients with locally advanced, relapsed, or metastatic disease', 'patients with advanced and metastatic bladder cancer', 'patients receiving prior platinum-based regimens and with poor renal reserve', '19 patients had glomerular filtration rate <60 ml min(-1) and 19 patients had metastatic disease']","['gemcitabine and fractionated cisplatin', 'GC', 'MVAC (methotrexate, vincristine, doxorubicin, cisplatin) vs gemcitabine and cisplatin (GC) ']","['overall median survival', 'Overall response rate', 'Significant haematologic toxicities', 'haematological toxicity', 'efficacy and lower toxicity (JCO 2000', 'maximum-tolerated dose and dose-limiting toxicity (DLT), objective response rate, and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",32.0,0.040011,"Overall response rate was 65.5% on an intention-to-treat analysis (75% [21/28] for assessable patients), with four complete responses (12.5%) and 17 partial responses (53%).","[{'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Cancer Research UK Institute for Cancer Studies, University of Birmingham B15 2TT, UK. hussainsa@cancer.bham.ac.uk'}, {'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Stocken', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Riley', 'Affiliation': ''}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': ''}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Peake', 'Affiliation': ''}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Geh', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Spooner', 'Affiliation': ''}, {'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': ''}]",British journal of cancer,[]
119,15365570,Elderly patients with fluoropyrimidine and thymidylate synthase inhibitor-resistant advanced colorectal cancer derive similar benefit without excessive toxicity when treated with irinotecan monotherapy.,"Elderly patients are recommended to have a reduced starting dose (300 mg m(-2) once every 3 weeks) of irinotecan monotherapy. The aims of this analysis are to compare toxicity and survival according to age, performance status (PS), gender and prior radical pelvic radiotherapy (RT). The primary end points were overall survival and an irinotecan-specific toxicity composite end point (TCE) defined as the occurrence of grade 3 or 4 diarrhoea, neutropenia, febrile neutropenia, fever, infection or nausea and vomiting. Between 1997 and 2003, 339 eligible patients with advanced colorectal cancer (CRC) progressing on or within 24 weeks of completing fluoropyrimidine-based chemotherapy were prospectively registered in a multicentre randomised trial. All patients commenced irinotecan at 350 mg m(-2) once every 3 weeks. There were no differences in proportions of patients developing TCE by age (<70 vs > or =70 : 37.8 vs 45.8%; P=0.218), PS (0-1 vs 2 : 39.3 vs 41.5%; P=0.793) or prior RT (RT vs no RT : 45.1 vs 38.5%; P=0.377). Males experienced more toxicity than females (44.3 vs 32.6%; P=0.031), but this was not significant after controlling for other co-variates (P=0.06). Patients aged > or =70 had similar objective responses (11.1 vs 9%; P=0.585) and survival (median 9.4 vs 9 months; log rank P=0.74) compared to younger patients. Elderly patients derive the same benefit without experiencing more toxicity with second-line irinotecan treatment for advanced CRC. Our data do not support the recommendation to reduce the starting dose for the elderly patients.",2004,"Males experienced more toxicity than females (44.3 vs 32.6%; P=0.031), but this was not significant after controlling for other co-variates (P=0.06).","['Between 1997 and 2003, 339 eligible patients with advanced colorectal cancer (CRC) progressing on or within 24 weeks of completing', 'Elderly patients with fluoropyrimidine and thymidylate synthase inhibitor-resistant advanced colorectal cancer', 'elderly patients', 'Elderly patients']","['fluoropyrimidine-based chemotherapy', 'radical pelvic radiotherapy (RT', 'irinotecan', 'irinotecan monotherapy']","['toxicity', 'toxicity and survival', 'overall survival and an irinotecan-specific toxicity composite end point (TCE) defined as the occurrence of grade 3 or 4 diarrhoea, neutropenia, febrile neutropenia, fever, infection or nausea and vomiting', 'survival', 'objective responses']","[{'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4522015', 'cui_str': 'Thymidylate synthase inhibitor'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",339.0,0.156155,"Males experienced more toxicity than females (44.3 vs 32.6%; P=0.031), but this was not significant after controlling for other co-variates (P=0.06).","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Royal Marsden Hospital, London and Surrey, UK.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Norman', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': ''}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Waters', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Topham', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Middleton', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Ross', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Katopodis', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Oates', 'Affiliation': ''}]",British journal of cancer,[]
120,15226773,Nutrition intervention is beneficial in oncology outpatients receiving radiotherapy to the gastrointestinal or head and neck area.,"Malnutrition occurs frequently in patients with cancer of the gastrointestinal (GI) or head and neck area and can lead to negative outcomes. The aim of this study is to determine the impact of early and intensive nutrition intervention (NI) on body weight, body composition, nutritional status, global quality of life (QoL) and physical function compared to usual practice in oncology outpatients receiving radiotherapy to the GI or head and neck area. Outpatients commencing at least 20 fractions of radiotherapy to the GI or head and neck area were randomised to receive intensive, individualised nutrition counselling by a dietitian using a standard protocol and oral supplements if required, or the usual practice of the centre (general advice and nutrition booklet). Outcome parameters were measured at baseline and 4, 8 and 12 weeks after commencing radiotherapy using valid and reliable tools. A total of 60 patients (51 M : 9 F; mean age 61.9+/-14.0 years) were randomised to receive either NI (n=29) or usual care (UC) (n=31). The NI group had statistically smaller deteriorations in weight (P<0.001), nutritional status (P=0.020) and global QoL (P=0.009) compared with those receiving UC. Clinically, but not statistically significant differences in fat-free mass were observed between the groups (P=0.195). Early and intensive NI appears beneficial in terms of minimising weight loss, deterioration in nutritional status, global QoL and physical function in oncology outpatients receiving radiotherapy to the GI or head and neck area. Weight maintenance in this population leads to beneficial outcomes and suggests that this, rather than weight gain, may be a more appropriate aim of NI.",2004,"Early and intensive NI appears beneficial in terms of minimising weight loss, deterioration in nutritional status, global QoL and physical function in oncology outpatients receiving radiotherapy to the GI or head and neck area.","['60 patients (51 M : 9 F; mean age 61.9+/-14.0 years', 'patients with cancer of the gastrointestinal (GI) or head and neck area', 'Outpatients commencing at least 20 fractions of radiotherapy to the GI or head and neck area', 'oncology outpatients receiving radiotherapy to the gastrointestinal or head and neck area', 'oncology outpatients receiving radiotherapy to the GI or head and neck area']","['intensive nutrition intervention (NI', 'Nutrition intervention', 'NI (n=29) or usual care (UC', 'intensive, individualised nutrition counselling by a dietitian using a standard protocol and oral supplements if required, or the usual practice of the centre (general advice and nutrition booklet']","['weight loss, deterioration in nutritional status, global QoL and physical function', 'global QoL', 'body weight, body composition, nutritional status, global quality of life (QoL) and physical function', 'fat-free mass', 'smaller deteriorations in weight (P<0.001), nutritional status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0034380'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",60.0,0.0349448,"Early and intensive NI appears beneficial in terms of minimising weight loss, deterioration in nutritional status, global QoL and physical function in oncology outpatients receiving radiotherapy to the GI or head and neck area.","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Isenring', 'Affiliation': 'School of Public Health, Queensland University of Technology, Brisbane, Australia. e.isenring@qut.edu.au'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Capra', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Bauer', 'Affiliation': ''}]",British journal of cancer,[]
121,19443665,"Effect of reducing indoor air pollution on women's respiratory symptoms and lung function: the RESPIRE Randomized Trial, Guatemala.","Exposure to household wood smoke from cooking is a risk factor for chronic obstructive lung disease among women in developing countries. The Randomized Exposure Study of Pollution Indoors and Respiratory Effects (RESPIRE) is a randomized intervention trial evaluating the respiratory health effects of reducing indoor air pollution from open cooking fires. A total of 504 rural Mayan women in highland Guatemala aged 15-50 years, all using traditional indoor open fires, were randomized to either receive a chimney woodstove (plancha) or continue using the open fire. Assessments of chronic respiratory symptoms and lung function and individual measurements of carbon monoxide exposure were performed at baseline and every 6 months up to 18 months. Use of a plancha significantly reduced carbon monoxide exposure by 61.6%. For all respiratory symptoms, reductions in risk were observed in the plancha group during follow-up; the reduction was statistically significant for wheeze (relative risk = 0.42, 95% confidence interval: 0.25, 0.70). The number of respiratory symptoms reported by the women at each follow-up point was also significantly reduced by the plancha (odds ratio = 0.7, 95% confidence interval: 0.50, 0.97). However, no significant effects on lung function were found after 12-18 months. Reducing indoor air pollution from household biomass burning may relieve symptoms consistent with chronic respiratory tract irritation.",2009,"For all respiratory symptoms, reductions in risk were observed in the plancha group during follow-up; the reduction was statistically significant for wheeze (relative risk = 0.42","['chronic obstructive lung disease among women in developing countries', 'chronic respiratory tract irritation', '504 rural Mayan women in highland Guatemala aged 15-50 years, all using traditional indoor open fires', ""women's respiratory symptoms and lung function"", 'indoor air pollution from open cooking fires']","['chimney woodstove (plancha) or continue using the open fire', 'household wood smoke from cooking', 'indoor air pollution']","['number of respiratory symptoms', 'lung function', 'chronic respiratory symptoms and lung function and individual measurements of carbon monoxide exposure', 'carbon monoxide exposure']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0011750', 'cui_str': 'Under-Developed Nations'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0854118', 'cui_str': 'Respiratory tract irritation'}, {'cui': 'C0454911', 'cui_str': 'Highland (geographic location)'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0702194', 'cui_str': 'Fire - domestic object'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0085420', 'cui_str': 'Air Pollution, Indoor'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}]","[{'cui': 'C0557689', 'cui_str': 'Chimney (physical object)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0702194', 'cui_str': 'Fire - domestic object'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0043217', 'cui_str': 'Wood'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0085420', 'cui_str': 'Air Pollution, Indoor'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0238889', 'cui_str': 'Exposure to carbon monoxide (event)'}]",504.0,0.053273,"For all respiratory symptoms, reductions in risk were observed in the plancha group during follow-up; the reduction was statistically significant for wheeze (relative risk = 0.42","[{'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Smith-Sivertsen', 'Affiliation': 'Department of Public Health and Primary Health Care, Faculty of Medicine and Dentistry, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Díaz', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Pope', 'Affiliation': ''}, {'ForeName': 'Rolv T', 'Initials': 'RT', 'LastName': 'Lie', 'Affiliation': ''}, {'ForeName': 'Anaite', 'Initials': 'A', 'LastName': 'Díaz', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McCracken', 'Affiliation': ''}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Bakke', 'Affiliation': ''}, {'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Arana', 'Affiliation': ''}, {'ForeName': 'Kirk R', 'Initials': 'KR', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Bruce', 'Affiliation': ''}]",American journal of epidemiology,['10.1093/aje/kwp100']
122,19271829,The cognitive reserve hypothesis: a longitudinal examination of age-associated declines in reasoning and processing speed.,"The term cognitive reserve is frequently used to refer to the ubiquitous finding that, during later life, those higher in experiential resources (e.g., education, knowledge) exhibit higher levels of cognitive function. This observation may be the result of either experiential resources playing protective roles with respect to the cognitive declines associated with aging or the persistence of differences in functioning that have existed since earlier adulthood. These possibilities were examined by applying accelerated longitudinal structural equation (growth curve) models to 5-year reasoning and speed data from the no-contact control group (N = 690; age 65-89 years at baseline) of the Advanced Cognitive Training for Independent and Vital Elderly study. Vocabulary knowledge and years of education, as markers of cognitive reserve, were related to levels of cognitive functioning but unrelated to rates of cognitive change, both before and after the (negative) relations between levels and rates were controlled for. These results suggest that cognitive reserve reflects the persistence of earlier differences in cognitive functioning rather than differential rates of age-associated cognitive declines.",2009,"Vocabulary knowledge and years of education, as markers of cognitive reserve, were related to levels of cognitive functioning but unrelated to rates of cognitive change, both before and after the (negative) relations between levels and rates were controlled for.",['contact control group (N = 690; age 65-89 years at baseline) of the Advanced Cognitive Training for Independent and Vital Elderly study'],[],['Vocabulary knowledge and years of education'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",690.0,0.0180946,"Vocabulary knowledge and years of education, as markers of cognitive reserve, were related to levels of cognitive functioning but unrelated to rates of cognitive change, both before and after the (negative) relations between levels and rates were controlled for.","[{'ForeName': 'Elliot M', 'Initials': 'EM', 'LastName': 'Tucker-Drob', 'Affiliation': 'Department of Psychology, University of Virginia, Charlottesville, VA 22904-4400, USA. tuckerdrob@virginia.edu'}, {'ForeName': 'Kathy E', 'Initials': 'KE', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': ''}]",Developmental psychology,['10.1037/a0014012']
123,15305182,Maintenance treatment with interferon for advanced ovarian cancer: results of the Northern and Yorkshire gynaecology group randomised phase III study.,A randomised phase III trial was conducted to assess the role of interferon-alpha (INFalpha) 2a as maintenance therapy following surgery and/or chemotherapy in patients with epithelial ovarian carcinoma. Patients were randomised following initial surgery/chemotherapy to interferon-alpha 2a as 4.5 mega-units subcutaneously 3 days per week or to no further treatment. A total of 300 patients were randomised within the study between February 1990 and July 1997. No benefit for interferon maintenance was seen in terms of either overall or clinical event-free survival. We conclude that INF-alpha is not effective as a maintenance therapy in the management of women with ovarian cancer. The need for novel therapeutics or strategies to prevent the almost inevitable relapse of patients despite increasingly effective surgery and chemotherapy remains.,2004,No benefit for interferon maintenance was seen in terms of either overall or clinical event-free survival.,"['women with ovarian cancer', '300 patients were randomised within the study between February 1990 and July 1997', 'patients with epithelial ovarian carcinoma', 'advanced ovarian cancer']","['initial surgery/chemotherapy to interferon-alpha 2a', 'surgery and/or chemotherapy', 'interferon', 'interferon-alpha (INFalpha) 2a', 'INF-alpha']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",[],300.0,0.0799714,No benefit for interferon maintenance was seen in terms of either overall or clinical event-free survival.,"[{'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Hall', 'Affiliation': ""Cancer Research UK Clinical Centre in Leeds, St James's University Hospital, Leeds, UK. g.hall@leeds.ac.uk""}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Coleman', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stead', 'Affiliation': ''}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Metcalf', 'Affiliation': ''}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Peel', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Poole', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Crawford', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hancock', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Selby', 'Affiliation': ''}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Perren', 'Affiliation': ''}]",British journal of cancer,[]
124,32435762,Protocol for two-arm pragmatic cluster randomized hybrid implementation-effectiveness trial comparing two education strategies for improving the uptake of noninvasive ventilation in patients with severe COPD exacerbation.,"Background


COPD is the fourth leading cause of death in the US, and COPD exacerbations result in approximately 700,000 hospitalizations annually. Patients with acute respiratory failure due to severe COPD exacerbation are treated with invasive (IMV) or noninvasive mechanical ventilation (NIV). Although IMV reverses hypercapnia/hypoxia, it causes significant morbidity and mortality. There is strong evidence that patients treated with NIV have better outcomes, and NIV is recommended as first line therapy in these patients. Yet, several studies have demonstrated substantial variation in the use of NIV across hospitals, leading to preventable morbidity and mortality. Through a series of mixed-methods studies, we have found that successful implementation of NIV requires physicians, respiratory therapists (RTs), and nurses to communicate and collaborate effectively, suggesting that efforts to increase the use of NIV in COPD need to account for the complex and interdisciplinary nature of NIV delivery and the need for team coordination. Therefore, we propose to compare two educational strategies: online education (OLE) and interprofessional education (IPE) which targets complex team-based care in NIV delivery.
Methods and design


Twenty hospitals with low baseline rates of NIV use will be randomized to either the OLE or IPE study arm. The primary outcome of the trial is change in the hospital rate of NIV use among patients with COPD requiring ventilatory support. In aim 1, we will compare the uptake change over time of NIV use among patients with COPD in hospitals enrolled in the two arms. In aim 2, we will explore mediators' role (respiratory therapist autonomy and team functionality) on the relationship between the implementation strategies and implementation effectiveness. Finally, in aim 3, through interviews with providers, we will assess acceptability and feasibility of the educational training.
Discussions


This study will be among the first to carefully test the impact of IPE in the inpatient setting. This work promises to change practice by offering approaches to facilitate greater uptake of NIV and may generalize to other interventions directed to seriously-ill patients.
Trial registration


Name of registry: ClinicalTrials.govTrial registration number: NCT04206735Date of Registration: December 20, 2019.",2020,The primary outcome of the trial is change in the hospital rate of NIV use among patients with COPD requiring ventilatory support.,"['Twenty hospitals with low baseline rates of NIV use', 'patients with COPD requiring ventilatory support', 'patients with severe COPD exacerbation', 'Patients with acute respiratory failure due to severe COPD exacerbation', 'ClinicalTrials.govTrial registration number', 'patients with COPD in hospitals enrolled in the two arms', 'Trial registration\n\n\nName of registry']","['invasive (IMV) or noninvasive mechanical ventilation (NIV', 'OLE', 'educational strategies: online education (OLE) and interprofessional education (IPE) which targets complex team-based care in NIV delivery']",['hospital rate of NIV use'],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1868982', 'cui_str': 'Noninvasive mechanical ventilation'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1868982', 'cui_str': 'Noninvasive mechanical ventilation'}, {'cui': 'C4505477', 'cui_str': 'Online Education'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1868982', 'cui_str': 'Noninvasive mechanical ventilation'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",20.0,0.289848,The primary outcome of the trial is change in the hospital rate of NIV use among patients with COPD requiring ventilatory support.,"[{'ForeName': 'Mihaela S', 'Initials': 'MS', 'LastName': 'Stefan', 'Affiliation': '1Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School-Baystate, Springfield, MA USA.'}, {'ForeName': 'Penelope S', 'Initials': 'PS', 'LastName': 'Pekow', 'Affiliation': '1Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School-Baystate, Springfield, MA USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Shea', 'Affiliation': '4Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina-Chapel Hill, Chapel Hill, NC USA.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Hughes', 'Affiliation': '5College of Applied Health Science, University of Illinois at Chicago, Chicago, IL USA.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Hill', 'Affiliation': '6Division of Pulmonary and Critical Care Medicine, Tufts University School of Medicine, Boston, MA USA.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Steingrub', 'Affiliation': '7Division of Pulmonary and Critical Care, Department of Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA USA.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Lindenauer', 'Affiliation': '1Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School-Baystate, Springfield, MA USA.'}]",Implementation science communications,['10.1186/s43058-020-00028-2']
125,16420204,"Cognitive function in normal-weight, overweight, and obese older adults: an analysis of the Advanced Cognitive Training for Independent and Vital Elderly cohort.","OBJECTIVES


To assess how elevated body mass index (BMI) affects cognitive function in elderly people.
DESIGN


Cross-sectional study.
SETTING


Data for this cross-sectional study were taken from a multicenter randomized controlled trial, the Advanced Cognitive Training for Independent and Vital Elderly trial.
PARTICIPANTS


The analytic sample included 2,684 normal-weight, overweight, or obese subjects aged 65 to 94.
MEASUREMENTS


Evaluation of cognitive abilities was performed in several domains: global cognition, memory, reasoning, and speed of processing. Cross-sectional association between body weight status and cognitive functions was analyzed using multiple linear regression.
RESULTS


Overweight subjects had better performance on a reasoning task (beta=0.23, standard error (SE)=0.11, P=.04) and the Useful Field of View (UFOV) measure (beta=-39.46, SE=12.95, P=.002), a test of visuospatial speed of processing, after controlling for age, sex, race, years of education, intervention group, study site, and cardiovascular risk factors. Subjects with class I (BMI 30.0-34.9 kg/m2) and class II (BMI>35.0 kg/m2) obesity had better UFOV measure scores (beta=-38.98, SE=14.77, P=.008; beta=-35.75, SE=17.65, and P=.04, respectively) in the multivariate model than normal-weight subjects. The relationships between BMI and individual cognitive domains were nonlinear.
CONCLUSION


Overweight participants had better cognitive performance in terms of reasoning and visuospatial speed of processing than normal-weight participants. Obesity was associated with better performance in visuospatial speed of processing than normal weight. The relationship between BMI and cognitive function should be studied prospectively.",2006,"RESULTS


Overweight subjects had better performance on a reasoning task (beta=0.23, standard error (SE)=0.11, P=.04) and the Useful Field of View (UFOV) measure (beta=-39.46, SE=12.95, P=.002), a test of visuospatial speed of processing, after controlling for age, sex, race, years of education, intervention group, study site, and cardiovascular risk factors.","['Overweight participants', 'Subjects with class', 'normal-weight, overweight, and obese older adults', 'The analytic sample included 2,684 normal-weight, overweight, or obese subjects aged 65 to 94', 'elderly people']",['Advanced Cognitive Training'],"['reasoning task', 'Useful Field of View (UFOV) measure', 'cognitive performance', 'body weight status and cognitive functions', 'Cognitive function', 'UFOV measure scores', 'several domains: global cognition, memory, reasoning, and speed of processing']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",2684.0,0.048196,"RESULTS


Overweight subjects had better performance on a reasoning task (beta=0.23, standard error (SE)=0.11, P=.04) and the Useful Field of View (UFOV) measure (beta=-39.46, SE=12.95, P=.002), a test of visuospatial speed of processing, after controlling for age, sex, race, years of education, intervention group, study site, and cardiovascular risk factors.","[{'ForeName': 'Hsu-Ko', 'Initials': 'HK', 'LastName': 'Kuo', 'Affiliation': 'Division on Aging, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Milberg', 'Affiliation': ''}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Tennstedt', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Talbot', 'Affiliation': ''}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': ''}]",Journal of the American Geriatrics Society,[]
126,25494333,Complexity-Based Measures Inform Effects of Tai Chi Training on Standing Postural Control: Cross-Sectional and Randomized Trial Studies.,"BACKGROUND


Diminished control of standing balance, traditionally indicated by greater postural sway magnitude and speed, is associated with falls in older adults. Tai Chi (TC) is a multisystem intervention that reduces fall risk, yet its impact on sway measures vary considerably. We hypothesized that TC improves the integrated function of multiple control systems influencing balance, quantifiable by the multi-scale ""complexity"" of postural sway fluctuations.
OBJECTIVES


To evaluate both traditional and complexity-based measures of sway to characterize the short- and potential long-term effects of TC training on postural control and the relationships between sway measures and physical function in healthy older adults.
METHODS


A cross-sectional comparison of standing postural sway in healthy TC-naïve and TC-expert (24.5±12 yrs experience) adults. TC-naïve participants then completed a 6-month, two-arm, wait-list randomized clinical trial of TC training. Postural sway was assessed before and after the training during standing on a force-plate with eyes-open (EO) and eyes-closed (EC). Anterior-posterior (AP) and medio-lateral (ML) sway speed, magnitude, and complexity (quantified by multiscale entropy) were calculated. Single-legged standing time and Timed-Up-and-Go tests characterized physical function.
RESULTS


At baseline, compared to TC-naïve adults (n = 60, age 64.5±7.5 yrs), TC-experts (n = 27, age 62.8±7.5 yrs) exhibited greater complexity of sway in the AP EC (P = 0.023), ML EO (P<0.001), and ML EC (P<0.001) conditions. Traditional measures of sway speed and magnitude were not significantly lower among TC-experts. Intention-to-treat analyses indicated no significant effects of short-term TC training; however, increases in AP EC and ML EC complexity amongst those randomized to TC were positively correlated with practice hours (P = 0.044, P = 0.018). Long- and short-term TC training were positively associated with physical function.
CONCLUSION


Multiscale entropy offers a complementary approach to traditional COP measures for characterizing sway during quiet standing, and may be more sensitive to the effects of TC in healthy adults.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01340365.",2014,"Intention-to-treat analyses indicated no significant effects of short-term TC training; however, increases in AP EC and ML EC complexity amongst those randomized to TC were positively correlated with practice hours (P = 0.044,","['healthy older adults', 'older adults', 'A cross-sectional comparison of standing postural sway in healthy TC-naïve and TC-expert (24.5±12 yrs experience) adults', 'healthy adults']","['Long- and short-term TC training', 'Tai Chi Training', 'training during standing on a force-plate with eyes-open (EO) and eyes-closed (EC', 'TC training', 'Tai Chi (TC', 'TC']","['sway speed and magnitude', 'Postural sway', 'complexity of sway in the AP EC', 'Anterior-posterior (AP) and medio-lateral (ML) sway speed, magnitude, and complexity (quantified by multiscale entropy', 'AP EC and ML EC complexity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}]",,0.0318222,"Intention-to-treat analyses indicated no significant effects of short-term TC training; however, increases in AP EC and ML EC complexity amongst those randomized to TC were positively correlated with practice hours (P = 0.044,","[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.""}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Gow', 'Affiliation': ""Osher Center for Integrative Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.""}, {'ForeName': 'Madalena D', 'Initials': 'MD', 'LastName': 'Costa', 'Affiliation': 'Division of Interdisciplinary Medicine and Biotechnology and Margret and H.A. Rey Institute for Nonlinear Dynamics in Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'C-K', 'Initials': 'CK', 'LastName': 'Peng', 'Affiliation': 'Division of Interdisciplinary Medicine and Biotechnology and Margret and H.A. Rey Institute for Nonlinear Dynamics in Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America; Center for Dynamical Biomarkers and Translational Medicine, National Central University, Chungli, Taiwan.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Division of Gerontology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America; Institute for Aging Research, Hebrew SeniorLife, Roslindale, Massachusetts, United States of America.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': 'Movement Disorders Unit, Department of Neurology, Tel Aviv Medical Center, Tel Aviv, Israel; Department of Physical Therapy and Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': 'Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Jacquelyn N', 'Initials': 'JN', 'LastName': 'Walsh', 'Affiliation': ""Osher Center for Integrative Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lough', 'Affiliation': 'Institute for Aging Research, Hebrew SeniorLife, Roslindale, Massachusetts, United States of America.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Novak', 'Affiliation': 'Division of Gerontology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America; Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Ahn', 'Affiliation': 'Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America; Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'Division of Gerontology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}]",PloS one,['10.1371/journal.pone.0114731']
127,31490772,Comparison of the effect of self-care education in a disaster with two student-centered and family-centered approaches to self-care in students.,"OBJECTIVES


The purpose of this research was to compare the effect of self-care education in disasters with two student-centered and family-centered approaches to self-care in students of the Red Crescent Societies in the city of Lenjan in 2017.
METHODS


One hundred and fifty individuals were selected by random sampling from 270 people. The research instrument was a questionnaire. The questionnaire was approved by the opinion of supervisors and other experts. The present research is a quasi-experimental study. The covariance analysis was used to determine the difference between the two groups in the experimental and control groups and the effect of educational intervention. All of the above steps were performed using the SPSS 23 statistical program.
RESULTS


The results indicate that there is a significant difference between the two groups in self-care through the student-centered approach. The mean of the self-care group with a family-centered approach (21.72) was more than the mean of the control group in this variable (16.61). Moreover, the mean of the self-care group's education with family-centered approaches (42.61) was more than the mean of self-care education h in a disaster with a student-centered approach (31.23).
CONCLUSION


According to the results of this study, it can be concluded that there is a significant difference between self-care education with two student-centered and family-based approaches to self-care in students, and a family-centered approach has better outcomes.",2019,The results indicate that there is a significant difference between the two groups in self-care through the student-centered approach.,"['a disaster with two student-centered and family-centered approaches to self-care in students', 'disasters with two student-centered and family-centered approaches to self-care in students of the Red Crescent Societies in the city of Lenjan in 2017', 'Methods One hundred and fifty individuals were selected by random sampling from 270 people']","['educational intervention', 'self-care education']",[],"[{'cui': 'C0012618', 'cui_str': 'Disasters'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0034907', 'cui_str': 'Red Crescent'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}]","[{'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],150.0,0.0214818,The results indicate that there is a significant difference between the two groups in self-care through the student-centered approach.,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Eskandari', 'Affiliation': 'MSc Student in Community Health Nursing, Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran.'}, {'ForeName': 'Minoo', 'Initials': 'M', 'LastName': 'Motaghi', 'Affiliation': 'Nursing Department, Faculty of Nursing and Midwifery, Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran.'}]",International journal of adolescent medicine and health,['10.1515/ijamh-2019-0113']
128,29729848,Development and Validation of a 28-gene Hypoxia-related Prognostic Signature for Localized Prostate Cancer.,"BACKGROUND


Hypoxia is associated with a poor prognosis in prostate cancer. This work aimed to derive and validate a hypoxia-related mRNA signature for localized prostate cancer.
METHOD


Hypoxia genes were identified in vitro via RNA-sequencing and combined with in vivo gene co-expression analysis to generate a signature. The signature was independently validated in eleven prostate cancer cohorts and a bladder cancer phase III randomized trial of radiotherapy alone or with carbogen and nicotinamide (CON).
RESULTS


A 28-gene signature was derived. Patients with high signature scores had poorer biochemical recurrence free survivals in six of eight independent cohorts of prostatectomy-treated patients (Log rank test P < .05), with borderline significances achieved in the other two (P < .1). The signature also predicted biochemical recurrence in patients receiving post-prostatectomy radiotherapy (n = 130, P = .007) or definitive radiotherapy alone (n = 248, P = .035). Lastly, the signature predicted metastasis events in a pooled cohort (n = 631, P = .002). Prognostic significance remained after adjusting for clinic-pathological factors and commercially available prognostic signatures. The signature predicted benefit from hypoxia-modifying therapy in bladder cancer patients (intervention-by-signature interaction test P = .0026), where carbogen and nicotinamide was associated with improved survival only in hypoxic tumours.
CONCLUSION


A 28-gene hypoxia signature has strong and independent prognostic value for prostate cancer patients.",2018,"Patients with high signature scores had poorer biochemical recurrence free survivals in six of eight independent cohorts of prostatectomy-treated patients (Log rank test P < .05), with borderline significances achieved in the other two (P < .1).","['bladder cancer patients', 'Localized Prostate Cancer', 'prostate cancer patients', 'eleven prostate cancer cohorts and a bladder cancer phase III randomized trial of']","['radiotherapy alone or with carbogen and nicotinamide (CON', 'definitive radiotherapy alone']","['biochemical recurrence', 'biochemical recurrence free survivals', 'survival']","[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0054692', 'cui_str': 'carbogen'}, {'cui': 'C0028027', 'cui_str': 'nicotinamide'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",11.0,0.0318936,"Patients with high signature scores had poorer biochemical recurrence free survivals in six of eight independent cohorts of prostatectomy-treated patients (Log rank test P < .05), with borderline significances achieved in the other two (P < .1).","[{'ForeName': 'Lingjian', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Translational Radiobiology Group, Division of Cancer Sciences, University of Manchester, Manchester Academic Health Science Centre, Christie Hospital, Manchester M20 4BX, UK.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Roberts', 'Affiliation': 'Translational Radiobiology Group, Division of Cancer Sciences, University of Manchester, Manchester Academic Health Science Centre, Christie Hospital, Manchester M20 4BX, UK.'}, {'ForeName': 'Mandeep', 'Initials': 'M', 'LastName': 'Takhar', 'Affiliation': 'GenomeDx Biosciences, Vancouver, BC, Canada.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Erho', 'Affiliation': 'GenomeDx Biosciences, Vancouver, BC, Canada.'}, {'ForeName': 'Becky A S', 'Initials': 'BAS', 'LastName': 'Bibby', 'Affiliation': 'Translational Radiobiology Group, Division of Cancer Sciences, University of Manchester, Manchester Academic Health Science Centre, Christie Hospital, Manchester M20 4BX, UK.'}, {'ForeName': 'Niluja', 'Initials': 'N', 'LastName': 'Thiruthaneeswaran', 'Affiliation': 'Translational Radiobiology Group, Division of Cancer Sciences, University of Manchester, Manchester Academic Health Science Centre, Christie Hospital, Manchester M20 4BX, UK; Princess Margaret Cancer Centre, University Health Network, Toronto, Canada.'}, {'ForeName': 'Vinayak', 'Initials': 'V', 'LastName': 'Bhandari', 'Affiliation': 'Informatics & Biocomputing Program, Ontario Institute for Cancer Research, Toronto, Canada; Sydney Medical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Cheng', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford OX3 7DQ, UK.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Haider', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford OX3 7DQ, UK; Weatherall Institute of Molecular Medicine, University of Oxford, Oxford OX3 9DS, UK.'}, {'ForeName': 'Amy M B', 'Initials': 'AMB', 'LastName': 'McCorry', 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University Belfast, Belfast BT9 7BL, Northern Ireland, UK.""}, {'ForeName': 'Darragh', 'Initials': 'D', 'LastName': 'McArt', 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University Belfast, Belfast BT9 7BL, Northern Ireland, UK.""}, {'ForeName': 'Suneil', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University Belfast, Belfast BT9 7BL, Northern Ireland, UK.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alshalalfa', 'Affiliation': 'GenomeDx Biosciences, Vancouver, BC, Canada.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Ross', 'Affiliation': 'James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Schaffer', 'Affiliation': 'Northwestern Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Den', 'Affiliation': 'Department of Radiation Oncology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, United States.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jeffrey Karnes', 'Affiliation': 'Department of Urology, Mayo Clinic Rochester, MN, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Klein', 'Affiliation': 'Glickman Urological Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hoskin', 'Affiliation': 'Mount Vernon Cancer Centre, Rickmansworth Road, Northwood, Middlesex HA6 2RN, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Freedland', 'Affiliation': 'Department of Surgery, Division of Urology, Center for Integrated Research on Cancer and Lifestyle, Samuel Oschin Comprehensive Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Alastair D', 'Initials': 'AD', 'LastName': 'Lamb', 'Affiliation': 'Cancer Research UK Cambridge Institute, University of Cambridge, Cambridge CB2 0RE, UK; Nuffield Department of Surgical Sciences, University of Oxford, Old Road Campus Research Building, Headington, Oxford OX3 7DQ, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Old Road Campus Research Building, Headington, Oxford OX3 7DQ, UK.'}, {'ForeName': 'Francesca M', 'Initials': 'FM', 'LastName': 'Buffa', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford OX3 7DQ, UK; Weatherall Institute of Molecular Medicine, University of Oxford, Oxford OX3 9DS, UK.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Bristow', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, Toronto, Canada; Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Boutros', 'Affiliation': 'Informatics & Biocomputing Program, Ontario Institute for Cancer Research, Toronto, Canada; Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Elai', 'Initials': 'E', 'LastName': 'Davicioni', 'Affiliation': 'GenomeDx Biosciences, Vancouver, BC, Canada.'}, {'ForeName': 'Ananya', 'Initials': 'A', 'LastName': 'Choudhury', 'Affiliation': 'Translational Radiobiology Group, Division of Cancer Sciences, University of Manchester, Manchester Academic Health Science Centre, Christie Hospital, Manchester M20 4BX, UK.'}, {'ForeName': 'Catharine M L', 'Initials': 'CML', 'LastName': 'West', 'Affiliation': 'Translational Radiobiology Group, Division of Cancer Sciences, University of Manchester, Manchester Academic Health Science Centre, Christie Hospital, Manchester M20 4BX, UK; NIHR Manchester Biomedical Research Centre, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, UK. Electronic address: catharine.west@manchester.ac.uk.'}]",EBioMedicine,['10.1016/j.ebiom.2018.04.019']
129,26304864,"Deferoxamine, Cerebrovascular Hemodynamics, and Vascular Aging: Potential Role for Hypoxia-Inducible Transcription Factor-1-Regulated Pathways.","BACKGROUND AND PURPOSE


Iron chelation therapy is emerging as a novel neuroprotective strategy. The mechanisms of neuroprotection are diverse and include both neuronal and vascular pathways. We sought to examine the effect of iron chelation on cerebrovascular function in healthy aging and to explore whether hypoxia-inducible transcription factor-1 activation may be temporally correlated with vascular changes.
METHODS


We assessed cerebrovascular function (autoregulation, vasoreactivity, and neurovascular coupling) and serum concentrations of vascular endothelial growth factor and erythropoietin, as representative measures of hypoxia-inducible transcription factor-1 activation, during 6 hours of deferoxamine infusion in 24 young and 24 older healthy volunteers in a randomized, blinded, placebo-controlled cross-over study design. Cerebrovascular function was assessed using the transcranial Doppler ultrasound. Vascular endothelial growth factor and erythropoietin serum protein assays were conducted using the Meso Scale Discovery platform.
RESULTS


Deferoxamine elicited a strong age- and time-dependent increase in the plasma concentrations of erythropoietin and vascular endothelial growth factor, which persisted ≤3 hours post infusion (age effect P=0.04; treatment×time P<0.01). Deferoxamine infusion also resulted in a significant time- and age-dependent improvement in cerebral vasoreactivity (treatment×time P<0.01; age P<0.01) and cerebral autoregulation (gain: age×time×treatment P=0.04).
CONCLUSIONS


Deferoxamine infusion improved cerebrovascular function, particularly in older individuals. The temporal association between improved cerebrovascular function and increased serum vascular endothelial growth factor and erythropoietin concentrations is supportive of shared hypoxia-inducible transcription factor-1-regulated pathways. Therefore, pharmacological activation of hypoxia-inducible transcription factor-1 to enhance cerebrovascular function may be a promising neuroprotective strategy in acute and chronic ischemic syndromes, especially in elderly patients.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT013655104.",2015,"Deferoxamine infusion also resulted in a significant time- and age-dependent improvement in cerebral vasoreactivity (treatment×time P<0.01; age P<0.01) and cerebral autoregulation (gain: age×time×treatment P=0.04).
","['24 young and 24 older healthy volunteers', 'healthy aging', 'elderly patients', 'older individuals']","['deferoxamine infusion', 'iron chelation', 'placebo', 'Deferoxamine']","['cerebrovascular function', 'plasma concentrations of erythropoietin and vascular endothelial growth factor', 'Cerebrovascular function', 'Deferoxamine, Cerebrovascular Hemodynamics, and Vascular Aging', 'cerebrovascular function (autoregulation, vasoreactivity, and neurovascular coupling) and serum concentrations of vascular endothelial growth factor and erythropoietin', 'cerebral vasoreactivity', 'cerebral autoregulation']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C2963171', 'cui_str': 'Ageing Well'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0011145', 'cui_str': 'Deferoxamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0011145', 'cui_str': 'Deferoxamine'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C4042905', 'cui_str': 'Neurovascular Coupling'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",24.0,0.0515436,"Deferoxamine infusion also resulted in a significant time- and age-dependent improvement in cerebral vasoreactivity (treatment×time P<0.01; age P<0.01) and cerebral autoregulation (gain: age×time×treatment P=0.04).
","[{'ForeName': 'Farzaneh A', 'Initials': 'FA', 'LastName': 'Sorond', 'Affiliation': ""From the Stroke Division, Department of Neurology (F.A.S., S.L.R., A.D.M.) and Laboratory of Genital Tract Biology, Department of Obstetrics, Gynecology and Reproductive Biology (R.F., S.R.), Brigham and Women's Hospital, Boston, MA; Cardiovascular Research Laboratory, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Boston, MA (C.O.T.); Department of Medicine, Hebrew SeniorLife Institute for Aging Research, Boston, MA (L.A.L.); Division of Gerontology, Beth Israel Deaconess Medical Center, Boston, MA (L.A.L.); and Department of Neurology, Physical Medicine and Rehabilitation, Obstetrics and Gynecology, and Medicine, Harvard Medical School, Boston, MA (F.A.S., C.O.T., R.F., L.A.L.). fsorond@partners.org.""}, {'ForeName': 'Can Ozan', 'Initials': 'CO', 'LastName': 'Tan', 'Affiliation': ""From the Stroke Division, Department of Neurology (F.A.S., S.L.R., A.D.M.) and Laboratory of Genital Tract Biology, Department of Obstetrics, Gynecology and Reproductive Biology (R.F., S.R.), Brigham and Women's Hospital, Boston, MA; Cardiovascular Research Laboratory, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Boston, MA (C.O.T.); Department of Medicine, Hebrew SeniorLife Institute for Aging Research, Boston, MA (L.A.L.); Division of Gerontology, Beth Israel Deaconess Medical Center, Boston, MA (L.A.L.); and Department of Neurology, Physical Medicine and Rehabilitation, Obstetrics and Gynecology, and Medicine, Harvard Medical School, Boston, MA (F.A.S., C.O.T., R.F., L.A.L.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'LaRose', 'Affiliation': ""From the Stroke Division, Department of Neurology (F.A.S., S.L.R., A.D.M.) and Laboratory of Genital Tract Biology, Department of Obstetrics, Gynecology and Reproductive Biology (R.F., S.R.), Brigham and Women's Hospital, Boston, MA; Cardiovascular Research Laboratory, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Boston, MA (C.O.T.); Department of Medicine, Hebrew SeniorLife Institute for Aging Research, Boston, MA (L.A.L.); Division of Gerontology, Beth Israel Deaconess Medical Center, Boston, MA (L.A.L.); and Department of Neurology, Physical Medicine and Rehabilitation, Obstetrics and Gynecology, and Medicine, Harvard Medical School, Boston, MA (F.A.S., C.O.T., R.F., L.A.L.).""}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Monk', 'Affiliation': ""From the Stroke Division, Department of Neurology (F.A.S., S.L.R., A.D.M.) and Laboratory of Genital Tract Biology, Department of Obstetrics, Gynecology and Reproductive Biology (R.F., S.R.), Brigham and Women's Hospital, Boston, MA; Cardiovascular Research Laboratory, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Boston, MA (C.O.T.); Department of Medicine, Hebrew SeniorLife Institute for Aging Research, Boston, MA (L.A.L.); Division of Gerontology, Beth Israel Deaconess Medical Center, Boston, MA (L.A.L.); and Department of Neurology, Physical Medicine and Rehabilitation, Obstetrics and Gynecology, and Medicine, Harvard Medical School, Boston, MA (F.A.S., C.O.T., R.F., L.A.L.).""}, {'ForeName': 'Raina', 'Initials': 'R', 'LastName': 'Fichorova', 'Affiliation': ""From the Stroke Division, Department of Neurology (F.A.S., S.L.R., A.D.M.) and Laboratory of Genital Tract Biology, Department of Obstetrics, Gynecology and Reproductive Biology (R.F., S.R.), Brigham and Women's Hospital, Boston, MA; Cardiovascular Research Laboratory, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Boston, MA (C.O.T.); Department of Medicine, Hebrew SeniorLife Institute for Aging Research, Boston, MA (L.A.L.); Division of Gerontology, Beth Israel Deaconess Medical Center, Boston, MA (L.A.L.); and Department of Neurology, Physical Medicine and Rehabilitation, Obstetrics and Gynecology, and Medicine, Harvard Medical School, Boston, MA (F.A.S., C.O.T., R.F., L.A.L.).""}, {'ForeName': 'Stanthia', 'Initials': 'S', 'LastName': 'Ryan', 'Affiliation': ""From the Stroke Division, Department of Neurology (F.A.S., S.L.R., A.D.M.) and Laboratory of Genital Tract Biology, Department of Obstetrics, Gynecology and Reproductive Biology (R.F., S.R.), Brigham and Women's Hospital, Boston, MA; Cardiovascular Research Laboratory, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Boston, MA (C.O.T.); Department of Medicine, Hebrew SeniorLife Institute for Aging Research, Boston, MA (L.A.L.); Division of Gerontology, Beth Israel Deaconess Medical Center, Boston, MA (L.A.L.); and Department of Neurology, Physical Medicine and Rehabilitation, Obstetrics and Gynecology, and Medicine, Harvard Medical School, Boston, MA (F.A.S., C.O.T., R.F., L.A.L.).""}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': ""From the Stroke Division, Department of Neurology (F.A.S., S.L.R., A.D.M.) and Laboratory of Genital Tract Biology, Department of Obstetrics, Gynecology and Reproductive Biology (R.F., S.R.), Brigham and Women's Hospital, Boston, MA; Cardiovascular Research Laboratory, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Boston, MA (C.O.T.); Department of Medicine, Hebrew SeniorLife Institute for Aging Research, Boston, MA (L.A.L.); Division of Gerontology, Beth Israel Deaconess Medical Center, Boston, MA (L.A.L.); and Department of Neurology, Physical Medicine and Rehabilitation, Obstetrics and Gynecology, and Medicine, Harvard Medical School, Boston, MA (F.A.S., C.O.T., R.F., L.A.L.).""}]",Stroke,['10.1161/STROKEAHA.115.009906']
130,31456489,Short term effects of a weight loss and healthy lifestyle programme for overweight and obese men delivered by German football clubs.,"Numbers of obese and overweight people continue to grow in Germany as they do worldwide. Men are affected more often but do less about it and few weight loss services attract men in particular. To evaluate the effectiveness of a men-only weight loss programme, Football Fans in Training (FFIT), delivered by football clubs in the German Bundesliga, we did a non-randomized trial with a waiting list control group. Participants' data were collected between January 2017 and July 2018. FFIT is a 12-week, group-based, weight loss programme and was delivered in stadia and facilities of 15 professional German Bundesliga clubs. Inclusion criteria were age 35-65 years, BMI ≥ 28 and waist circumference ≥100 cm. Clubs recruited participants through Social Media, E-Mail and match day advertisement. 477 German male football fans were allocated to the intervention group by order of registration date at their respective clubs. 84 participants on the waiting list were allocated to the control group. Primary outcome was mean difference in weight loss with treatment condition over time as independent variable. We performed a multilevel mixed-effects linear regression analysis. Results were based on Intention-to-treat (ITT) analysis with Multiple Imputation. After 12 weeks, the mean weight loss of the intervention group adjusted for club, course and participants' age was 6.24 kg (95% CI 5.82-6.66) against 0.50 kg (-0.47-1.49) in the comparison group ( p  < 0.001). The results indicate that Football Fans in Training effectively helped German men to reduce their weight and waist circumference.",2020,477 German male football fans were allocated to the intervention group by order of registration date at their respective clubs.,"['477 German male football fans', 'overweight and obese men delivered by German football clubs', ""Participants' data were collected between January 2017 and July 2018"", '84 participants on waiting list', '15 professional German Bundesliga clubs', 'Clubs recruited participants through Social Media, E-Mail and match day advertisement', 'Inclusion criteria were age 35-65 years, BMI\u2009≥\u200928 and waist circumference ≥100\u2005cm']","['weight loss and healthy lifestyle programme', 'men-only weight loss program, Football Fans in Training (FFIT), delivered by football clubs', 'FFIT']","['weight and waist circumference', 'mean weight loss', 'weight loss']","[{'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0441039', 'cui_str': 'Fan (physical object)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0441039', 'cui_str': 'Fan (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",84.0,0.0601009,477 German male football fans were allocated to the intervention group by order of registration date at their respective clubs.,"[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Pietsch', 'Affiliation': 'Institute for Therapy and Health Research, Kiel, Germany.'}, {'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Weisser', 'Affiliation': 'Department of Sports Medicine, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Reiner', 'Initials': 'R', 'LastName': 'Hanewinkel', 'Affiliation': 'Institute for Therapy and Health Research, Kiel, Germany.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Gray', 'Affiliation': 'Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hunt', 'Affiliation': 'Institute for Social Marketing, University of Stirling, Stirling, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Matthis', 'Initials': 'M', 'LastName': 'Morgenstern', 'Affiliation': 'Institute for Therapy and Health Research, Kiel, Germany.'}]",European journal of sport science,['10.1080/17461391.2019.1660809']
131,31633313,Baseline Psychosocial and Demographic Factors Associated with Study Attrition and 12-Month Weight Gain in the DIETFITS Trial.,"OBJECTIVE


The purpose of this study was to examine correlates of failure-trial attrition and weight gain-in a randomized clinical weight-loss trial.
METHODS


The Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) trial included 609 adults (18-50 years; BMI 28-40). Participants were randomized to a 12-month healthy low-fat or healthy low-carbohydrate diet for weight loss. At baseline, participants completed psychosocial, demographic, and anthropometric measures. Stepwise logistic regressions identified baseline factors associated with (1) study attrition and (2) among trial completers, weight gain at 12 months.
RESULTS


Having higher baseline food addiction and self-efficacy was linked to treatment failure. Being younger, not having a college education, having higher outcome expectations and quality of life, and having lower social functioning and self-control increased the odds of trial attrition. Identifying as other than non-Hispanic white; not being married or cohabitating; having higher cognitive restraint and self-control; and having lower amotivation, family encouragement, and physical limitations increased the odds of gaining weight by treatment's end.
CONCLUSIONS


Participants' baseline psychosocial and demographic factors may support or impede successful weight loss. Trialists should attend to these factors when designing treatments in order to promote participants' likelihood of completing the trial and achieving their weight-loss goals.",2019,Having higher baseline food addiction and self-efficacy was linked to treatment failure.,['609 adults (18-50 years; BMI 28-40'],"['healthy low-fat or healthy low-carbohydrate diet for weight loss', 'Diet Intervention']","['weight gain', 'Study Attrition and 12-Month Weight Gain', 'Baseline Psychosocial and Demographic Factors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011292', 'cui_str': 'Demographic Factors'}]",609.0,0.0533071,Having higher baseline food addiction and self-efficacy was linked to treatment failure.,"[{'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Fielding-Singh', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Patel', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22650']
132,15173858,Multicenter randomized phase III trial of epirubicin plus paclitaxel vs epirubicin followed by paclitaxel in metastatic breast cancer patients: focus on cardiac safety.,"The aim of the study was to evaluate cardiac safety of two different schedules of Epirubicin and Paclitaxel in advanced breast cancer patients enrolled into a multicenter randomized phase III trial. Patients received Epirubicin 90 mg m(-2) plus Paclitaxel 200 mg m(-2) (3-h infusion) on day 1 every 3 weeks for eight courses (arm A), or Epirubicin 120 mg m(-2) on day 1 every 3 weeks for four courses followed by four courses of Paclitaxel 250 mg m(-2) on day 1 every 3 weeks (arm B). Left ventricular ejection fraction was evaluated by bidimesional echocardiography at baseline, after four and eight courses of chemotherapy and every 4 months during follow-up. Baseline median left ventricular ejection fraction was 60% in arm A and 65% in arm B; after four courses, figures were 57 and 60%, respectively. After eight courses, the median left ventricular ejection fraction in arm A declined to 50% while no further reduction was detected in arm B by adding four courses of high-dose Paclitaxel. Seven episodes of congestive heart failure were observed during treatment in arm A. Present monitoring demonstrated that the risk of congestive heart failure or impairment in the cardiac function correlated only with the cumulative dose of Epirubicin; no impact on cardiotoxicity can be attributed to high-dose Paclitaxel.",2004,"After eight courses, the median left ventricular ejection fraction in arm A declined to 50% while no further reduction was detected in arm B by adding four courses of high-dose Paclitaxel.","['metastatic breast cancer patients', 'advanced breast cancer patients']","['paclitaxel', 'Paclitaxel', 'epirubicin plus paclitaxel vs epirubicin', 'Epirubicin', 'Epirubicin and Paclitaxel', 'Epirubicin 90 mg m(-2) plus Paclitaxel']","['cardiotoxicity', 'congestive heart failure', 'Baseline median left ventricular ejection fraction', 'cardiac safety', 'median left ventricular ejection fraction', 'Left ventricular ejection fraction']","[{'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0876994', 'cui_str': 'Cardiac Toxicity'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",,0.0395507,"After eight courses, the median left ventricular ejection fraction in arm A declined to 50% while no further reduction was detected in arm B by adding four courses of high-dose Paclitaxel.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Baldini', 'Affiliation': 'Medical Oncology Department, S. Chiara University-Hospital, Via Roma 67, 56132 Pisa, Italy. e.baldini@do.med.unipi.it'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Prochilo', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Salvadori', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bolognesi', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aldrighetti', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Venturini', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rosso', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Carnino', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gallo', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Giannessi', 'Affiliation': ''}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Conte', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Orlandini', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bruzzi', 'Affiliation': ''}]",British journal of cancer,[]
133,30802277,Primary HIV prevention in pregnant and lactating Ugandan women: A randomized trial.,"BACKGROUND


The 'Primary HIV Prevention among Pregnant and Lactating Ugandan Women' (PRIMAL) study aimed to assess the effectiveness of an enhanced HIV counseling intervention for preventing HIV acquisition among HIV-uninfected mothers during pregnancy and throughout the breastfeeding period.
METHODS


We conducted an unblinded randomized control trial between 22 February 2013 and 22 April 2016 to assess the effectiveness of an extended repeat HIV testing and enhanced counseling (ERHTEC) intervention aimed at preventing primary HIV infection among HIV-uninfected pregnant and lactating women in Uganda. HIV-uninfected pregnant women aged 15-49 were enrolled 1:1 individually or in couples together with their partner. Enrolled women and couples were randomized 1:1 to an intervention (ERHTEC) or control (extended repeat HIV testing and standard counseling) group and followed up to 24 months postpartum or six weeks past complete cessation of breastfeeding, whichever came first. Both groups were tested for sexually transmitted infections (STIs) and HIV at enrollment, delivery, 3 and 6 months postpartum and every 6 months thereafter until the end of follow-up. The intervention group received enhanced HIV prevention counseling every 3 months throughout follow-up. The control group received standard counseling at the time of HIV retesting. Both intervention and control couples were offered couple HIV testing and counseling at all study visits.
MAIN OUTCOME MEASURES


Frequency of condom use and incidence of HIV, syphilis, gonorrhea, chlamydia and trichomoniasis over follow-up.
RESULTS


Between February 2013 and April 2014, we enrolled 820 HIV-uninfected pregnant women presenting for antenatal care individually (n = 410) or in couples (n = 410 women and 410 partners) in one urban and one rural public Ugandan hospital. Women's median age was 24 years (IQR 20-28 years). At baseline, participants did not differ in any socio-demographic, reproductive health, HIV testing history, sexual behavior, medical history or STI status characteristics; 96% (386/402) of couples were tested and counseled for HIV together with their partners at enrolment, 2.1% (7/329) of whom were found to be HIV-infected. Six hundred twenty-five (76%) women completed follow-up as per protocol (S1 Protocol). Women were followed for an average of 1.76 years and cumulated 1,439 women-years of follow-up or 81% of the maximum 1,779 women-years of follow-up assuming no dropouts. Men were followed for an average of 1.72 years. The frequency of consistent condom use and the proportion of women who used condoms over the last 3 months or at last vaginal sex increased substantially over follow-up in both arms, but there were no statistically significant differences in increases between the intervention and control arms. During follow-up, on average 42% (range 36%-46%) of couple partners were counseled together. Between 3.8% and 7.6% of women tested positive at any follow-up visit for any STI including syphilis, gonorrhea, C. trachomatis or T. vaginalis. Four women (two in each arm) and no enrolled men became infected with HIV, representing an overall HIV incidence rate of 0.186 per 100 person-years. Three of the women seroconverters had enrolled individually, one as a couple. At or before seroconversion, all four women reported their partners had extramarital relationships and/or had not disclosed their suspected HIV-infected status. There were no statistically significant differences between study arms for STI or HIV incidences.
CONCLUSIONS


A sustained enhanced HIV prevention counseling intervention for up to 2 years postpartum among pregnant and breastfeeding women did not have a statistically significant effect on condom use or HIV incidence among these women. However, in both study arms, condom use increased over follow-up while STI and HIV incidence remained very low when compared to similar cohorts in and outside Uganda, suggesting that repeat HIV testing during breastfeeding, whether with enhanced or standard counseling, may have had an unintended HIV preventive effect among pregnant and lactating women in this setting. Further research is needed to verify this hypothesis.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01882998.",2019,"There were no statistically significant differences between study arms for STI or HIV incidences.
","['pregnant and lactating', ""Women's median age was 24 years (IQR 20-28 years"", 'Ugandan women', 'Six hundred twenty-five (76%) women completed follow-up as per protocol (S1 Protocol', 'HIV-uninfected pregnant and lactating women in Uganda', '22 February 2013 and 22 April 2016', 'HIV-uninfected pregnant women aged 15-49', 'Women were followed for an average of 1.76 years and cumulated 1,439 women-years of follow-up or 81% of the maximum 1,779 women-years of follow-up assuming no dropouts', 'Four women (two in each arm) and no enrolled men became infected with HIV, representing an overall HIV incidence rate of 0.186 per 100 person-years', 'Between February 2013 and April 2014', 'HIV-uninfected mothers during pregnancy and throughout the breastfeeding period', 'Enrolled women and couples', 'pregnant and lactating women', 'Pregnant and Lactating', '820 HIV-uninfected pregnant women presenting for antenatal care individually (n = 410) or in couples (n = 410 women and 410 partners) in one urban and one rural public Ugandan hospital']","['intervention (ERHTEC) or control (extended repeat HIV testing and standard counseling', 'enhanced HIV prevention counseling', 'HIV prevention counseling intervention', 'enhanced HIV counseling intervention', 'extended repeat HIV testing and enhanced counseling (ERHTEC) intervention', 'standard counseling']","['condom use or HIV incidence', 'Frequency of condom use and incidence of HIV, syphilis, gonorrhea, chlamydia and trichomoniasis over follow-up', 'socio-demographic, reproductive health, HIV testing history, sexual behavior, medical history or STI status characteristics', 'STI or HIV incidences', 'HIV acquisition']","[{'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}]","[{'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0039128', 'cui_str': 'Great Pox'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0040921', 'cui_str': 'Trichomoniases'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C1321876', 'cui_str': 'Human immunodeficiency virus test (procedure)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",820.0,0.10125,"There were no statistically significant differences between study arms for STI or HIV incidences.
","[{'ForeName': 'Jaco', 'Initials': 'J', 'LastName': 'Homsy', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Bannink', 'Affiliation': 'AVSI Foundation, Kampala, Uganda.'}, {'ForeName': 'Zikulah', 'Initials': 'Z', 'LastName': 'Namukwaya', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghof', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Amone', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Ojok', 'Affiliation': 'AVSI Foundation, Kampala, Uganda.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Rukundo', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Amama', 'Affiliation': 'AVSI Foundation, Kampala, Uganda.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Etima', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Matovu', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Fitti', 'Initials': 'F', 'LastName': 'Weissglas', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Ojom', 'Affiliation': 'AVSI Foundation, Kampala, Uganda.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Atim', 'Affiliation': ""St Joseph's Hospital, Kitgum, Uganda.""}, {'ForeName': 'Lynae', 'Initials': 'L', 'LastName': 'Darbes', 'Affiliation': 'Department of Health Behavior and Biological Sciences, Center for Sexuality and Health Disparities, University of Michigan School of Nursing, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Josaphat', 'Initials': 'J', 'LastName': 'Byamugisha', 'Affiliation': 'Department of Obstetrics and Gynecology, Makerere University School of Medicine, Kampala, Uganda.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Rutherford', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Katabira', 'Affiliation': 'Department of Medicine & College of Health Sciences, Makerere University School of Medicine, Kampala, Uganda.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0212119']
134,31996717,Gut microbiota plasticity is correlated with sustained weight loss on a low-carb or low-fat dietary intervention.,"While low-carbohydrate and low-fat diets can both lead to weight-loss, a substantial variability in achieved long-term outcomes exists among obese but otherwise healthy adults. We examined the hypothesis that structural differences in the gut microbiota explain a portion of variability in weight-loss using two cohorts of obese adults enrolled in the Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) study. A total of 161 pre-diet fecal samples were sequenced from a discovery cohort (n = 66) and 106 from a validation cohort (n = 56). An additional 157 fecal samples were sequenced from the discovery cohort after 10 weeks of dietary intervention. We found no specific bacterial signatures associated with weight loss that were consistent across both cohorts. However, the gut microbiota plasticity (i.e. variability), was correlated with long-term (12-month) weight loss in a diet-dependent manner; on the low-fat diet subjects with higher pre-diet daily plasticity had higher sustained weight loss, whereas on the low-carbohydrate diet those with higher plasticity over 10 weeks of dieting had higher 12-month weight loss. Our findings suggest the potential importance of gut microbiota plasticity for sustained weight-loss. We highlight the advantages of evaluating kinetic trends and assessing reproducibility in studies of the gut microbiota.",2020,We found no specific bacterial signatures associated with weight loss that were consistent across both cohorts.,"['A total of 161 pre-diet fecal samples were sequenced from a discovery cohort (n = 66) and 106 from a validation cohort (n = 56', 'obese but otherwise healthy adults']",['Diet Intervention Examining'],"['weight loss', 'sustained weight loss', 'long-term (12-month) weight loss', 'gut microbiota plasticity']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}]",161.0,0.0139624,We found no specific bacterial signatures associated with weight loss that were consistent across both cohorts.,"[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Grembi', 'Affiliation': 'Department of Civil and Environmental Engineering, Stanford University, 318 Campus Drive E250 Clark Center, Stanford, CA, 94305, United States. jgrembi@stanford.edu.'}, {'ForeName': 'Lan H', 'Initials': 'LH', 'LastName': 'Nguyen', 'Affiliation': 'Institute for Computational and Mathematical Engineering, Stanford University, 475 Via Ortega, Stanford, CA, 94305, United States.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Haggerty', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, 291 Campus Drive, Stanford, CA, 94305, United States.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, 1265 Welch Road, Stanford, CA, 94305, United States.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Holmes', 'Affiliation': 'Department of Statistics, Stanford University, 390 Serra Mall, Stanford, CA, 94305, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Parsonnet', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, 291 Campus Drive, Stanford, CA, 94305, United States.'}]",Scientific reports,['10.1038/s41598-020-58000-y']
135,32506663,Novel delivery of cellular therapy to reduce ischemia reperfusion injury in kidney transplantation.,"Ex vivo normothermic machine perfusion (NMP) of donor kidneys prior to transplantation provides a platform for direct delivery of cellular therapeutics to optimize organ quality prior to transplantation. Multipotent Adult Progenitor Cells (MAPC ®  ) possess potent immunomodulatory properties that could minimize ischemia reperfusion injury. We investigated the potential capability of MAPC cells in kidney NMP. Pairs (5) of human kidneys, from the same donor, were simultaneously perfused for 7 hours. Kidneys were randomly allocated to receive MAPC treatment or control. Serial samples of perfusate, urine, and tissue biopsies were taken for comparison. MAPC-treated kidneys demonstrated improved urine output (P = .009), decreased expression of injury biomarker NGAL (P = .012), improved microvascular perfusion on contrast-enhanced ultrasound (cortex P = .019, medulla P = .001), downregulation of interleukin (IL)-1β (P = .050), and upregulation of IL-10 (P < .047) and Indolamine-2, 3-dioxygenase (P = .050). A chemotaxis model demonstrated decreased neutrophil recruitment when stimulated with perfusate from MAPC-treated kidneys (P < .001). Immunofluorescence revealed prelabeled MAPC cells in the perivascular space of kidneys during NMP. We report the first successful delivery of cellular therapy to a human kidney during NMP. Kidneys treated with MAPC cells demonstrate improvement in clinically relevant parameters and injury biomarkers. This novel method of cell therapy delivery provides an exciting opportunity to recondition organs prior to transplantation.",2021,"MAPC-treated kidneys demonstrated improved urine-output (p=0.009), decreased expression of injury biomarker NGAL (p=0.012), improved microvascular perfusion on contrast enhanced ultrasound (cortex p=0.019, medulla p=0.001), downregulation of IL-1β (p=0.050) and upregulation of IL-10 (p<0.047) and Indolamine-2, 3-dioxygenase (p=0.050).","['kidney transplantation', 'human kidney during NMP', 'kidney NMP']","['MAPC treatment or control', 'cellular therapy', 'MAPC cells', 'Ex-vivo normothermic machine perfusion (NMP', 'Multipotent Adult Progenitor Cells (MAPC ®  ']","['Immunofluorescence revealed pre-labelled MAPC cells', 'urine-output', 'neutrophil recruitment', 'expression of injury biomarker NGAL', 'microvascular perfusion', 'downregulation of IL-1β (p=0.050) and upregulation of IL-10']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0302189', 'cui_str': 'Therapy, Cell'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}]","[{'cui': 'C0016318', 'cui_str': 'Fluorescent identification of anti-nuclear antibody'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0751982', 'cui_str': 'Neutrophil Recruitment'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0215955', 'cui_str': 'LCN2 protein, human'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0013081', 'cui_str': 'Down-regulation'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.0198533,"MAPC-treated kidneys demonstrated improved urine-output (p=0.009), decreased expression of injury biomarker NGAL (p=0.012), improved microvascular perfusion on contrast enhanced ultrasound (cortex p=0.019, medulla p=0.001), downregulation of IL-1β (p=0.050) and upregulation of IL-10 (p<0.047) and Indolamine-2, 3-dioxygenase (p=0.050).","[{'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Thompson', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Bates', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ibrahim K', 'Initials': 'IK', 'LastName': 'Ibrahim', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Sewpaul', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Stenberg', 'Affiliation': 'Department of Radiology, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McNeill', 'Affiliation': 'Department of Radiology, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Figueiredo', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Girdlestone', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Georgina C', 'Initials': 'GC', 'LastName': 'Wilkins', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Tingle', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Scott', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'de Paula Lemos', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Mellor', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Valerie D', 'Initials': 'VD', 'LastName': 'Roobrouck', 'Affiliation': 'ReGenesys, Leuven, Belgium.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Ting', 'Affiliation': 'Athersys Inc., Cleveland, OH, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Hosgood', 'Affiliation': ""NIHR Blood and Transplant Research Unit, Department of Surgery, Addenbrooke's Hospital, University of Cambridge, Cambridge, UK.""}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Nicholson', 'Affiliation': ""NIHR Blood and Transplant Research Unit, Department of Surgery, Addenbrooke's Hospital, University of Cambridge, Cambridge, UK.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Fisher', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Simi', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Neil S', 'Initials': 'NS', 'LastName': 'Sheerin', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Colin H', 'Initials': 'CH', 'LastName': 'Wilson', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16100']
136,32515245,"Feasibility, acceptability, and preliminary impact of telemedicine-administered cognitive behavioral therapy for adherence and depression among African American women living with HIV in the rural South.",Women living with HIV are disproportionally affected by depression and mental healthcare access. A pilot feasibility trial using videoconferencing compared cognitive behavioral therapy for antiretroviral therapy adherence and depression ( N  = 11) to supportive psychotherapy ( N  = 11). Participants completed 10-12 weekly therapy sessions and 6-month follow-up. Retention at 6 months was 95 percent. Depression symptoms significantly decreased in both arms; antiretroviral therapy adherence remained high as measured via self-report and Wisepill. Satisfaction with intervention components was high; videoconferencing was highly acceptable and comparable to face-to-face counseling. This study demonstrates the feasibility of telemedicine-administered psychotherapy addressing mental health needs among women living with HIV.,2021,Satisfaction with intervention components was high; videoconferencing was highly acceptable and comparable to face-to-face counseling.,"['Women living with HIV', 'African American women living with HIV in the rural South', 'women living with HIV']","['videoconferencing compared cognitive behavioral therapy', 'telemedicine-administered cognitive behavioral therapy', 'supportive psychotherapy', 'telemedicine-administered psychotherapy']","['adherence and depression', 'Depression symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0794594,Satisfaction with intervention components was high; videoconferencing was highly acceptable and comparable to face-to-face counseling.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Junkins', 'Affiliation': 'The University of Alabama at Birmingham, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Psaros', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Corilyn', 'Initials': 'C', 'LastName': 'Ott', 'Affiliation': 'The University of Alabama at Birmingham, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'The University of Alabama at Birmingham, USA.'}, {'ForeName': 'Crystal Chapman', 'Initials': 'CC', 'LastName': 'Lambert', 'Affiliation': 'The University of Alabama at Birmingham, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cropsey', 'Affiliation': 'The University of Alabama at Birmingham, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Savage', 'Affiliation': 'The University of Alabama at Birmingham, USA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Safren', 'Affiliation': 'University of Miami, USA.'}, {'ForeName': 'Mirjam-Colette', 'Initials': 'MC', 'LastName': 'Kempf', 'Affiliation': 'The University of Alabama at Birmingham, USA.'}]",Journal of health psychology,['10.1177/1359105320926526']
137,32508201,Attentional bias to diabetes cues mediates disease management improvements in a pilot randomized controlled trial for adolescents with type 1 diabetes.,"For type 1 diabetes management, the role of attentional bias remains unclear. This secondary analysis examined type 1 diabetes attentional bias and adolescent type 1 diabetes management prior to and during a cognitive and behavioral intervention. Youth with type 1 diabetes and above target glycemic control were assigned to intervention or usual care control. Participants completed baseline and follow-up type 1 diabetes Stroop tasks, HbA1c tests, and blood glucose meter downloads. Intervention was associated with greater reductions in type 1 diabetes attentional bias than control, and these reductions partially mediated the effect of treatment on diabetes management behaviors. Type 1 diabetes attentional bias is a potential target to improve type 1 diabetes management.",2021,"Intervention was associated with greater reductions in type 1 diabetes attentional bias than control, and these reductions partially mediated the effect of treatment on diabetes management behaviors.","['Youth with type 1 diabetes and above target glycemic control', 'adolescents with type 1 diabetes']",['intervention or usual care control'],"['diabetes Stroop tasks, HbA1c tests, and blood glucose meter downloads', 'diabetes management behaviors', 'type 1 diabetes attentional bias']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0472226', 'cui_str': 'Blood glucose meters'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}]",,0.0201172,"Intervention was associated with greater reductions in type 1 diabetes attentional bias than control, and these reductions partially mediated the effect of treatment on diabetes management behaviors.","[{'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Crochiere', 'Affiliation': 'Drexel University, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hughes Lansing', 'Affiliation': 'University of Nevada, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Carracher', 'Affiliation': 'Geisel School of Medicine at Dartmouth, USA.'}, {'ForeName': 'Esha', 'Initials': 'E', 'LastName': 'Vaid', 'Affiliation': 'Pennsylvania State University, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stanger', 'Affiliation': 'Geisel School of Medicine at Dartmouth, USA.'}]",Journal of health psychology,['10.1177/1359105320926535']
138,32510238,Evaluation of abdominal exercises after stoma surgery: a descriptive study.,"PURPOSE


To evaluate the feasibility of exercises for the abdominal muscles in patients after colostomy or ileostomy formation on the following parameters: muscle activity, pain, discomfort, and difficulty of performing the exercises.
MATERIALS AND METHODS


Patients with a new stoma were divided into groups based on time after surgery: Early group, 0-2 weeks ( n  = 12); Intermediate group, 2-6 weeks ( n  = 15); and Late group, 6-12 weeks ( n  = 10). During a single individual test session, participants in each group performed a different set of 10-11 abdominal coordination and strengthening exercises for the abdominal muscles. Activity of the abdominal muscles was measured with electromyography. Pain, discomfort, and difficulty were rated for each exercise.
RESULTS


For the Early group, muscle activity reaching a predetermined threshold was measured for half of the participants in a few exercises. In both the Intermediate group and the Late group, muscle activity reaching the onset criteria was measured for all muscles for a high percentage of participants in several exercises. Both strengthening and coordinating exercises were feasible based on low ratings of pain, discomfort, and difficulty.
CONCLUSIONS


This study identified feasible exercises that activated the abdominal muscles at different time points after stoma formation. The observations can be used as guidance for the choice of exercises in clinical practice and future research.Implications for rehabilitationThe findings of this study can be used in clinical practice as guidance for choice of exercise at different time points after surgery.This study identified useful exercises for activating the abdominal muscles in rehabilitation after stoma surgery from two weeks on.In the first two postoperative weeks, there was limited involvement of the abdominal muscles with the evaluated exercises.Most of the evaluated abdominal exercises were feasible after stoma surgery based on pain, discomfort, and difficulty.",2022,"In both the Intermediate group and the Late group, muscle activity reaching the onset criteria was measured for all muscles for a high percentage of participants in several exercises.","['patients after colostomy or ileostomy formation on the following parameters', 'after stoma surgery', 'Patients with a new stoma']","['abdominal exercises', '10-11 abdominal coordination and strengthening exercises']","['muscle activity', 'muscle activity, pain, discomfort, and difficulty of performing the exercises', 'Pain, discomfort, and difficulty', 'muscle activity reaching', 'Activity of the abdominal muscles', 'pain, discomfort, and difficulty']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0454354', 'cui_str': 'Abdominal exercises'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0000739', 'cui_str': 'Skeletal muscle structure of abdomen'}]",,0.0217735,"In both the Intermediate group and the Late group, muscle activity reaching the onset criteria was measured for all muscles for a high percentage of participants in several exercises.","[{'ForeName': 'Rune Martens', 'Initials': 'RM', 'LastName': 'Andersen', 'Affiliation': 'Department of Surgical Gastroenterology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Thordis', 'Initials': 'T', 'LastName': 'Thomsen', 'Affiliation': 'Department of Anesthesiology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anne Kjærgaard', 'Initials': 'AK', 'LastName': 'Danielsen', 'Affiliation': 'Department of Gastroenterology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Gögenur', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Alkjær', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tyge', 'Initials': 'T', 'LastName': 'Nordentoft', 'Affiliation': 'Department of Gastroenterology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Possfelt-Møller', 'Affiliation': 'Department of Surgical Gastroenterology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Vinther', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte, Copenhagen, Denmark.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1771620']
139,32522040,Goal achievement and adaptive goal adjustment in a behavioral intervention for participants with prediabetes.,"Participants with prediabetes were supported to achieve and maintain weight loss with a stage-based behavior change group program named PREview behavior Modification Intervention Toolbox (PREMIT). The tendency to engage in a process of goal adjustment was examined in relation to PREMIT attendance. Analyses were based on 1857 participants who had achieved ⩾8percent weight loss. Tendency to engage in a process of goal adjustment appeared not to be influenced by PREMIT attendance. Instead, results suggested that when unsure about reaching an intervention goal, participants were more likely to engage in a process of goal adjustment, possibly lessening distress due to potentially unachievable goals, either weight loss or maintenance.",2021,Tendency to engage in a process of goal adjustment appeared not to be influenced by PREMIT attendance.,"['participants with prediabetes', '1857 participants who had achieved ⩾8percent weight loss', 'Participants with prediabetes']",['PREview behavior Modification Intervention Toolbox (PREMIT'],['weight loss or maintenance'],"[{'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",1857.0,0.0240008,Tendency to engage in a process of goal adjustment appeared not to be influenced by PREMIT attendance.,"[{'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Huttunen-Lenz', 'Affiliation': 'University of Education Schwäbisch Gmünd, Germany.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Hansen', 'Affiliation': 'University of Stuttgart, Germany.'}, {'ForeName': 'Pia Siig', 'Initials': 'PS', 'LastName': 'Vestentoft', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meinert Larsen', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Westerterp-Plantenga', 'Affiliation': 'Maastricht University, The Netherlands.'}, {'ForeName': 'Mathijs', 'Initials': 'M', 'LastName': 'Drummen', 'Affiliation': 'Maastricht University, The Netherlands.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Adam', 'Affiliation': 'Maastricht University, The Netherlands.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Macdonald', 'Affiliation': 'University of Nottingham, UK.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'University of Nottingham, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Simpson', 'Affiliation': 'University of Nottingham, UK.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martinez', 'Affiliation': 'University of Navarra, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Navas-Carretero', 'Affiliation': 'University of Navarra, Spain.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Handjieva-Darlenska', 'Affiliation': 'Medical University of Sofia, Bulgaria.'}, {'ForeName': 'Sally D', 'Initials': 'SD', 'LastName': 'Poppitt', 'Affiliation': 'The University of Auckland, New Zealand.'}, {'ForeName': 'Martha P', 'Initials': 'MP', 'LastName': 'Silvestre', 'Affiliation': 'The University of Auckland, New Zealand.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Fogelholm', 'Affiliation': 'University of Helsinki, Finland.'}, {'ForeName': 'Elli', 'Initials': 'E', 'LastName': 'Jalo', 'Affiliation': 'University of Helsinki, Finland.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Muirhead', 'Affiliation': 'The University of Sydney, Australia.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Brodie', 'Affiliation': 'The University of Sydney, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Brand-Miller', 'Affiliation': 'The University of Sydney, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Raben', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schlicht', 'Affiliation': 'University of Stuttgart, Germany.'}]",Journal of health psychology,['10.1177/1359105320925150']
140,32519327,The Effect of Video-Assisted Education Prior Intrathecal Chemotherapy on Anxiety and Knowledge Enhancement.,"Intrathecal chemotherapy procedures are stressful to patients and caregivers, especially the first time. Providing the patient and caregiver with sufficient information to address their concerns before the scheduled procedure is necessary. This study aims to determine whether the use of video instructions could enhance learning outcomes and decrease anxiety levels in patients' caregivers. A prospective trial was conducted in pediatric hematology for 1 year. Thirty-seven respondents were randomly assigned to two groups wherein one group was given conventional educational leaflets and verbal instructions, while the other group received the same information through an educational video presentation before the intrathecal chemotherapy procedure. Knowledge enhancement in the two groups was evaluated using the summative assessment method and measured by a 10-point Likert scale. The validated Arabic version of the Beck Anxiety Inventory (BAI) scale was used to assess anxiety levels. The anxiety level (12.31 ± 8.84) in the video presentation group was significantly higher than that in the conventional group (6.16 ± 5.91). Similarly, the overall Beck scale score revealed that palpitation, frightening, lightheadedness, and hot/cold sweat levels were decreased in the video presentation group. Additionally, a significant difference in knowledge enhancement was noted between the two groups, as knowledge enhancement in the video presentation group (7.61 ± 1.88) was better than that in the conventional group (6.00 ± 1.00). This produced a domino effect on the anxiety level scores of both groups. An educational video presentation before the intrathecal chemotherapy procedure is effective since both visual and auditory senses are involved. This could be considered a good source of an interventional approach before a therapeutic procedure.",2022,The anxiety level (12.31 ± 8.84) in the video presentation group was significantly higher than that in the conventional group (6.16 ± 5.91).,"['Thirty-seven respondents', 'pediatric hematology for 1\xa0year', ""patients' caregivers""]","['Intrathecal chemotherapy procedures', 'conventional educational leaflets and verbal instructions, while the other group received the same information through an educational video presentation before the intrathecal chemotherapy procedure', 'Video-Assisted Education Prior Intrathecal Chemotherapy', 'video instructions']","['anxiety level scores', 'validated Arabic version of the Beck Anxiety Inventory (BAI) scale', 'anxiety level', 'overall Beck scale score revealed that palpitation, frightening, lightheadedness, and hot/cold sweat levels', 'knowledge enhancement', 'Anxiety and Knowledge Enhancement', 'anxiety levels', 'learning outcomes']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C1690538', 'cui_str': 'Pediatric hematology'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C3665472', 'cui_str': 'Chemotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0232431', 'cui_str': 'Cold sweat'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",37.0,0.0290394,The anxiety level (12.31 ± 8.84) in the video presentation group was significantly higher than that in the conventional group (6.16 ± 5.91).,"[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Bany Hamdan', 'Affiliation': 'Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia. ahamdan@kfmc.med.sa.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Ballourah', 'Affiliation': 'Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Assem', 'Initials': 'A', 'LastName': 'Elghazaly', 'Affiliation': 'Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sherwynn', 'Initials': 'S', 'LastName': 'Javison', 'Affiliation': 'Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Alshammary', 'Affiliation': 'Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Erlandez', 'Affiliation': 'Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Garatli', 'Affiliation': 'National Neuroscience Institute, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Husain', 'Initials': 'H', 'LastName': 'Mohammed', 'Affiliation': 'National Neuroscience Institute, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Musa', 'Initials': 'M', 'LastName': 'Alharbi', 'Affiliation': 'Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01787-1']
141,32591439,"Kidney Disease, Intensive Hypertension Treatment, and Risk for Dementia and Mild Cognitive Impairment: The Systolic Blood Pressure Intervention Trial.","BACKGROUND


Intensively treating hypertension may benefit cardiovascular disease and cognitive function, but at the short-term expense of reduced kidney function.
METHODS


We investigated markers of kidney function and the effect of intensive hypertension treatment on incidence of dementia and mild cognitive impairment (MCI) in 9361 participants in the randomized Systolic Blood Pressure Intervention Trial, which compared intensive versus standard systolic BP lowering (targeting <120 mm Hg versus <140 mm Hg, respectively). We categorized participants according to baseline and longitudinal changes in eGFR and urinary albumin-to-creatinine ratio. Primary outcomes were occurrence of adjudicated probable dementia and MCI.
RESULTS


Among 8563 participants who completed at least one cognitive assessment during follow-up (median 5.1 years), probable dementia occurred in 325 (3.8%) and MCI in 640 (7.6%) participants. In multivariable adjusted analyses, there was no significant association between baseline eGFR <60 ml/min per 1.73 m 2  and risk for dementia or MCI. In time-varying analyses, eGFR decline ≥30% was associated with a higher risk for probable dementia. Incident eGFR <60 ml/min per 1.73 m 2  was associated with a higher risk for MCI and a composite of dementia or MCI. Although these kidney events occurred more frequently in the intensive treatment group, there was no evidence that they modified or attenuated the effect of intensive treatment on dementia and MCI incidence. Baseline and incident urinary ACR ≥30 mg/g were not associated with probable dementia or MCI, nor did the urinary ACR modify the effect of intensive treatment on cognitive outcomes.
CONCLUSIONS


Among hypertensive adults, declining kidney function measured by eGFR is associated with increased risk for probable dementia and MCI, independent of the intensity of hypertension treatment.",2020,Incident eGFR <60 ml/min per 1.73 m 2  was associated with a higher risk for MCI and a composite of dementia or MCI.,"['hypertensive adults', '8563 participants who completed at least one', 'Kidney Disease, Intensive Hypertension Treatment, and Risk for Dementia and Mild Cognitive Impairment', '9361 participants in the randomized Systolic Blood Pressure Intervention Trial, which compared intensive versus standard systolic BP lowering (targeting <120 mm Hg versus <140 mm Hg, respectively']",['intensive hypertension treatment'],"['incidence of dementia and mild cognitive impairment (MCI', 'eGFR and urinary albumin-to-creatinine ratio', 'dementia and MCI incidence', 'cognitive assessment', 'kidney events', 'probable dementia', 'occurrence of adjudicated probable dementia and MCI']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",9361.0,0.140303,Incident eGFR <60 ml/min per 1.73 m 2  was associated with a higher risk for MCI and a composite of dementia or MCI.,"[{'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Kurella Tamura', 'Affiliation': 'Geriatric Research and Education Clinical Center, Palo Alto VA Health Care System, Palo Alto, California mktamura@stanford.edu.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Gordon J', 'Initials': 'GJ', 'LastName': 'Chelune', 'Affiliation': ""Center for Alzheimer's Care, Imaging and Research, University of Utah School of Medicine, Salt Lake City, Utah.""}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Section of Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Gure', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Killeen', 'Affiliation': 'Departments of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Vascular Biology and Hypertension Program, Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Dena E', 'Initials': 'DE', 'LastName': 'Rifkin', 'Affiliation': 'Division of Nephrology, University of California San Diego, San Diego, California.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Supiano', 'Affiliation': 'Division of Geriatrics, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': ""Sticht Center for Healthy Aging and Alzheimer's Prevention and Division of Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.""}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020010038']
142,32567869,Longitudinal effects of psychotherapy with transgender and nonbinary clients: A randomized controlled pilot trial.,"Minority stress has been determined to contribute to some mental health concerns for transgender, nonbinary, and gender nonconforming individuals, yet little is known regarding interventions to decrease the effects of minority stress. The purpose of this pilot study was to assess the feasibility and relative effectiveness of two interventions developed for work with transgender clients. Transgender individuals ( N  = 20) were recruited to participate in a randomized controlled trial comparing two psychotherapy interventions for transgender adults seeking psychotherapy for a variety of concerns: (a) transgender affirmative psychotherapy (TA) and (b) Building Awareness of Minority Stressors + Transgender Affirmative psychotherapy. Gender-related stress and resilience were assessed before, immediately after, and 6 months following the intervention; psychological distress and working alliance were assessed at these three time points as well as weekly during the intervention. Feasibility and acceptability of the study and psychotherapy interventions were supported. Exploratory analyses indicate improvement in both groups based on general outcome measures; targeted outcome measures indicate a trend of improvement for internalized stigma and nonaffirmation experiences. Results from this study support further evaluation of both treatment arms in a larger randomized controlled trial. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,Exploratory analyses indicate improvement in both groups based on general outcome measures; targeted outcome measures indicate a trend of improvement for internalized stigma and nonaffirmation experiences.,"['Transgender individuals ( N  = 20', 'and nonbinary clients']","['psychotherapy interventions for transgender adults seeking psychotherapy for a variety of concerns: (a) transgender affirmative psychotherapy (TA) and (b) Building Awareness of Minority Stressors + Transgender Affirmative psychotherapy', 'psychotherapy with transgender']","['psychological distress and working alliance', 'internalized stigma and nonaffirmation experiences', 'feasibility and relative effectiveness', 'Feasibility and acceptability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]","[{'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",20.0,0.0655726,Exploratory analyses indicate improvement in both groups based on general outcome measures; targeted outcome measures indicate a trend of improvement for internalized stigma and nonaffirmation experiences.,"[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Budge', 'Affiliation': 'Department of Counseling Psychology.'}, {'ForeName': 'Morgan T', 'Initials': 'MT', 'LastName': 'Sinnard', 'Affiliation': 'Department of Counseling Psychology.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Hoyt', 'Affiliation': 'Department of Counseling Psychology.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000310']
143,32461568,The Arclight vs. traditional ophthalmoscope: a cross-over trial.,"BACKGROUND/OBJECTIVES


To compare skill acquisition of the new, cost-effective Arclight ophthalmoscope, with the traditional ophthalmoscope (TO), in medical students with no prior experience of ophthalmoscopy.
SUBJECTS/METHODS


University of Dundee medical students took part in a cross-over trial. Students were divided into two groups and were alternately taught each device using a video tutorial. In period one, Group A was taught the TO first; Group B was taught the Arclight. They were then assessed using simulated objective, structured, clinical, examinations, examining four model heads with lettered fundal photographs of varying sizes of font. Groups crossed over following a 2-week washout period and were taught the second device and reassessed. A questionnaire was distributed to ascertain students' opinions and preferences.
RESULTS


Forty medical students participated. Overall, 92.5% of students performed better with the Arclight, irrespective of cross-over trial period. The mean difference in score in period one of the cross-over trial was 16.77 (95% CI: 11.63-21.93), with students performing better with the Arclight (p < 0.0001). The mean difference in score in period two was 8.02 (95% CI: 4.52-11.52), with students performing better with the Arclight (p < 0.0001). In addition, performance with the TO improved by 52.9% following initial exposure to the Arclight. The Arclight was the preferred device by 82.5% of students, and 82.5% of students would choose this device for future practice.
CONCLUSION


Students performed better with and preferred the Arclight ophthalmoscope. The Arclight could be considered as a suitable alternative to the TO used for training medical students.",2021,"The Arclight was the preferred device by 82.5% of students, and 82.5% of students would choose this device for future practice.
","['Forty medical students participated', 'medical students with no prior experience of ophthalmoscopy', 'University of Dundee medical students took part in a cross-over trial']",['traditional ophthalmoscope (TO'],[],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0029090', 'cui_str': 'Ophthalmoscopy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0182046', 'cui_str': 'Ophthalmoscope'}]",[],,0.0218472,"The Arclight was the preferred device by 82.5% of students, and 82.5% of students would choose this device for future practice.
","[{'ForeName': 'Monica Lorraina', 'Initials': 'ML', 'LastName': 'Hytiris', 'Affiliation': 'Ninewells Hospital and Medical School, Dundee, UK. monica.hytiris@nhs.net.'}, {'ForeName': 'Evridiki', 'Initials': 'E', 'LastName': 'Fioratou', 'Affiliation': 'Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Stewart N', 'Initials': 'SN', 'LastName': 'Gillan', 'Affiliation': 'Ninewells Hospital and Medical School, Dundee, UK.'}]","Eye (London, England)",['10.1038/s41433-020-0972-3']
144,32543247,Prolonged enoxaparin therapy compared with standard-of-care antithrombotic therapy in opiate-treated patients undergoing primary percutaneous coronary intervention.,"A novel enoxaparin regimen consisting of intra-arterial bolus (0.75 mg/kg) followed by intravenous infusion (0.75 mg/kg/6 hours) has been developed as a possible solution to the delayed absorption of oral P2Y 12  inhibitors in opiate-treated ST-elevation myocardial infarction (STEMI) patients undergoing primary angioplasty. We aimed to study the feasibility of this regimen as an alternative to standard-of-care treatment (SOC) with unfractionated heparin ± glycoprotein IIb/IIIa antagonist (GPI). One hundred opiate-treated patients presenting with STEMI and accepted for primary angioplasty were randomized (1:1) to either enoxaparin or SOC. Fifty patients were allocated enoxaparin (median age 61, 40% females) and 49 allocated SOC (median age 62, 22% females). One developed stroke before angiography and was withdrawn. One SOC patient had a gastrointestinal bleed resulting in 1 g drop in hemoglobin and early cessation of GPI infusion. Two enoxaparin patients had transient minor bleeding: one transient gingival bleed and one episode of coffee ground vomit with no hemoglobin drop or hemodynamic instability. Two SOC and no enoxaparin group patients had acute stent thrombosis. These preliminary data support further study of this novel 6-hour enoxaparin regimen in opiate-treated PPCI patients.",2021,Two SOC and no enoxaparin group patients had acute stent thrombosis.,"['One hundred opiate-treated patients presenting with STEMI and accepted for primary angioplasty', 'Fifty patients were allocated', 'opiate-treated PPCI patients', 'median age 61, 40% females) and 49 allocated SOC (median age 62, 22% females', 'opiate-treated patients undergoing primary percutaneous coronary intervention']","['standard-of-care treatment (SOC) with unfractionated heparin ± glycoprotein IIb/IIIa antagonist (GPI', 'enoxaparin or SOC', 'enoxaparin therapy', 'standard-of-care antithrombotic therapy', 'enoxaparin']","['transient minor bleeding: one transient gingival bleed and one episode of coffee ground vomit with no hemoglobin drop or hemodynamic instability', 'gastrointestinal bleed', 'acute stent thrombosis']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0016011', 'cui_str': 'Glycoproteins IIb-IIIa'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0017759', 'cui_str': 'Glucose-6-phosphate isomerase'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",50.0,0.0391926,Two SOC and no enoxaparin group patients had acute stent thrombosis.,"[{'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Sumaya', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'William A E', 'Initials': 'WAE', 'LastName': 'Parker', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Judge', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Hall', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Orme', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Zulfiquar', 'Initials': 'Z', 'LastName': 'Adam', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Richardson', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Alexander M K', 'Initials': 'AMK', 'LastName': 'Rothman', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Morgan', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Julian P', 'Initials': 'JP', 'LastName': 'Gunn', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield, Sheffield, UK.'}]",Platelets,['10.1080/09537104.2020.1779925']
145,32593173,Pharmacodynamic studies of nasal tetracosactide with salivary glucocorticoids for a noninvasive Short Synacthen Test.,"CONTEXT


The Short Synacthen Test (SST) is the gold standard for diagnosing adrenal insufficiency. It requires invasive administration of Synacthen, venous sampling, and is resource-intensive.
OBJECTIVE


To develop a nasally administered SST, with salivary glucocorticoids measurement, to assess the adrenal response.
DESIGN


We conducted 5 studies: 4 open-label, sequence-randomized, crossover, pharmacodynamic studies testing 6 doses/formulations and a repeatability study. Additionally, pharmacokinetic analysis was undertaken using our chosen formulation, 500 µg tetracosactide with mucoadhesive chitosan, Nasacthin003, in our pediatric study.
SETTING


Adult and children's clinical research facilities.
PARTICIPANTS


A total of 36 healthy adult males and 24 healthy children.
INTERVENTION


We administered all 6 nasal formulations using an European regulator endorsed atomization device. The IV comparators were 250 µg or 1 µg SST.
MAIN OUTCOME MEASURES


We analyzed paired blood and saliva samples for plasma cortisol and salivary cortisol and cortisone.
RESULTS


The addition of chitosan to tetracosactide and dose escalation increased peak cortisol response (P = 0.01 and 0.001, respectively). The bioavailability of Nasacthin003 was 14.3%. There was no significant difference in plasma cortisol at 60 minutes between 500 µg Nasacthin003 and 250 µg IV Synacthen (P = 0.17). The repeatability coefficient at 60 minutes was 105 nmol/L for IV Synacthen and salivary cortisol and cortisone was 10.3 and 21.1 nmol/L, respectively. The glucocorticoid response in children was indistinguishable from that of adults.
CONCLUSIONS


Nasal administration of Nasacthin003 generates equivalent plasma cortisol values to the 250-µg IV SST and, with measurement at 60 minutes of salivary cortisol or cortisone, provides a noninvasive test for adrenal insufficiency.",2020,"The addition of chitosan to tetracosactide and dose escalation increased peak cortisol response (P = 0.01 and 0.001, respectively).","[""Adult and children's clinical research facilities"", 'A total of 36 healthy adult males and 24 healthy children']",['salivary glucocorticoids'],"['plasma cortisol and salivary cortisol and cortisone', 'bioavailability of Nasacthin003', 'plasma cortisol values', 'peak cortisol response', 'repeatability coefficient', 'plasma cortisol', 'glucocorticoid response']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0686744', 'cui_str': 'Well child'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]",36.0,0.0457079,"The addition of chitosan to tetracosactide and dose escalation increased peak cortisol response (P = 0.01 and 0.001, respectively).","[{'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'Elder', 'Affiliation': 'Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Vilela', 'Affiliation': 'Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Trevor N', 'Initials': 'TN', 'LastName': 'Johnson', 'Affiliation': 'Certara UK Limited, Sheffield, United Kingdom.'}, {'ForeName': 'Rosie N', 'Initials': 'RN', 'LastName': 'Taylor', 'Affiliation': 'Statistical Services Unit, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'E Helen', 'Initials': 'EH', 'LastName': 'Kemp', 'Affiliation': 'Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Keevil', 'Affiliation': 'Department of Clinical Biology, Manchester University NHS Trust, Manchester, United Kingdom.'}, {'ForeName': 'Alexandra S', 'Initials': 'AS', 'LastName': 'Cross', 'Affiliation': 'Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Ross', 'Affiliation': 'Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Neil P', 'Initials': 'NP', 'LastName': 'Wright', 'Affiliation': ""Department of Endocrinology, Sheffield Children's NHS Foundation Trust, Sheffield, United Kingdom.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa323']
146,32546749,Compliance behaviour change in contact lens wearers: a randomised controlled trial.,"BACKGROUND


Water exposure during contact lens wear has been associated with contact lens disease including microbial keratitis and sterile corneal infiltrates. Despite the documented risks, water exposure is common amongst lens wearers. This study aimed to determine the effect of water education in the form of ""no-water"" lens case stickers on water-contact behaviours and storage case contamination.
METHODS


In a prospective, masked, randomised controlled trial, 200 daily lens wearers were randomised to either receive a storage case with a ""no-water"" sticker (test) or without a ""no-water"" sticker (control). Both groups received written compliance information. Participants completed a self-administered lens hygiene questionnaire at baseline and after 6 weeks. Microbial analysis of used storage cases, collected at both study visits, was conducted using ATP and limulus amebocyte lysate (LAL) assays for overall microbial contamination and endotoxin levels, respectively. A one-way ANCOVA and multiple logistic regression determined the change in water-contact behaviours and storage case contamination over time.
RESULTS


A total of 188 lens wearers completed both study visits; 128 females and 60 males; average age 29 ± 13 (range 18-78 years); 95 test and 93 control participants. After 6 weeks, the overall water exposure score and endotoxin levels reduced significantly in the test group compared with the control group (p < 0.05). There were no significant changes in individual water-contact behaviours or overall storage case contamination.
CONCLUSION


A no-water infographic on the contact lens case improved overall water-contact behaviours and reduced storage case endotoxin. Refining the messaging may be beneficial in future to improve other aspects of compliance.",2021,"After 6 weeks, the overall water exposure score and endotoxin levels reduced significantly in the test group compared with the control group (p < 0.05).","['200 daily lens wearers', '188 lens wearers completed both study visits; 128 females and 60 males; average age 29\u2009±\u200913 (range 18-78 years); 95 test and 93 control participants', 'contact lens wearers']","['storage case with a ""no-water"" sticker (test) or without a ""no-water"" sticker (control']","['self-administered lens hygiene questionnaire', 'overall water exposure score and endotoxin levels', 'overall water-contact behaviours and reduced storage case endotoxin', 'Compliance behaviour change', 'individual water-contact behaviours or overall storage case contamination']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0920138', 'cui_str': 'Contact lens wearer'}]","[{'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014264', 'cui_str': 'Bacterial endotoxin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",200.0,0.10914,"After 6 weeks, the overall water exposure score and endotoxin levels reduced significantly in the test group compared with the control group (p < 0.05).","[{'ForeName': 'Memoona', 'Initials': 'M', 'LastName': 'Arshad', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia. m.arshad@unsw.edu.au.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Carnt', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Stapleton', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.'}]","Eye (London, England)",['10.1038/s41433-020-1015-9']
147,32564251,Effectiveness of Decision Aid in Men with Localized Prostate Cancer: a Multicenter Randomized Controlled Trial at Tertiary Referral Hospitals in an Asia Pacific Country.,"There are several treatment options for localized prostate cancer with very similar outcome but vary in terms of technique and side effect profiles and risks. Considering the potential difficulty in choosing the best treatment, a patient decision aid (PDA) is used to help patients in their decision-making process. However, the use and applicability of PDA in a country in Asia Pacific region like Malaysia is still unknown. This study aims to evaluate the effectiveness of a PDA modified to the local context in improving patients' knowledge, decisional conflict, and preparation for decision making among men with localized prostate cancer. Sixty patients with localized prostate cancer were randomly assigned to control and intervention groups. A self-administered questionnaire, which evaluate the knowledge on prostate cancer (23 items), decisional conflict (10 items) and preparation for decision-making (10 items), was given to all participants at pre- and post-intervention. Data were analyzed using independent T test and paired T test. The intervention group showed significant improvement in knowledge (p = 0.02) and decisional conflict (p = 0.01) from baseline. However, when compared between the control and intervention groups, there were no significant differences at baseline and post-intervention on knowledge, decisional conflict and preparation for decision-making. A PDA on treatment options of localized prostate cancer modified to the local context in an Asia Pacific country improved patients' knowledge and decisional conflict but did not have significant impact on the preparation for decision-making. The study was also registered under the Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12614000668606 registered on 25/06/2014.",2022,The intervention group showed significant improvement in knowledge (p = 0.02) and decisional conflict (p = 0.01) from baseline.,"['men with localized prostate cancer', 'Men with Localized Prostate Cancer', 'Sixty patients with localized prostate cancer']","['Decision Aid', 'PDA']","['knowledge, decisional conflict and preparation for decision-making', 'knowledge', 'decisional conflict']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",60.0,0.0384246,The intervention group showed significant improvement in knowledge (p = 0.02) and decisional conflict (p = 0.01) from baseline.,"[{'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Jalil', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'P Y', 'Initials': 'PY', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia. yein@upm.edu.my.'}, {'ForeName': 'M Z', 'Initials': 'MZ', 'LastName': 'Nor Afiah', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Abdullah', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'F N S Mohd', 'Initials': 'FNSM', 'LastName': 'Azizi', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'N N S Abdul', 'Initials': 'NNSA', 'LastName': 'Rassip', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Ong', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Ng', 'Affiliation': 'Department of Primary Care Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Y K', 'Initials': 'YK', 'LastName': 'Lee', 'Affiliation': 'Department of Primary Care Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Cheong', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Razack', 'Affiliation': 'Department of Surgery, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Saad', 'Affiliation': 'Department of Clinical Oncology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alip', 'Affiliation': 'Department of Clinical Oncology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Malek', 'Affiliation': 'Unit of Urology, Selayang Hospital, Selangor, Malaysia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sundram', 'Affiliation': 'Unit of Urology, General Hospital of Kuala Lumpur, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Omar', 'Affiliation': 'Unit of Urology, Johor Bahru Hospital, Johor Bahru, Johor, Malaysia.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Sathiyananthan', 'Affiliation': 'Unit of Urology, Penang Hospital, Penang, Malaysia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Department of Surgery, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01801-6']
148,32592861,"Antidepressant efficacy and immune effects of bilateral theta burst stimulation monotherapy in major depression: A randomized, double-blind, sham-controlled study.","Inflammation theory has been consolidated by accumulating evidence, and many studies have suggested that the peripheral cytokine levels could be biomarkers for disease status and treatment outcome in major depressive disorder (MDD). Theta burst stimulation (TBS), a new form of repetitive transcranial magnetic stimulation (TMS) for MDD, has been demonstrated to improve depression via modulating dysfunctional neural network or hypothalamic–pituitary–adrenal axis hyperactivities in MDD. However, there is lack of exploratory studies investigating its effect on serum inflammatory cytokines. Here, we aimed to investigate the antidepressant efficacy of bilateral TBS monotherapy and its effects on the serum cytokine levels in MDD. We conducted a double-blind, randomized, sham-controlled trial, with 53 MDD patients who exhibited no responses to at least one adequate antidepressant treatment for the prevailing episode assigned randomly to one of two groups: bilateral TBS monotherapy (n = 27) or sham stimulation (n = 26). The TBS treatment period was 22 days. Blood samples from 31 study subjects were obtained for analyses. The bilateral TBS group exhibited significantly greater decreases in depression scores than the sham group at week 4 (56.5% vs. 33.1%; p < 0.001 [effect size (Cohen ’ s d) = 1.00]) and during the 20-week follow-up periods. Significantly more responders were also found at week 4 (70.3% vs. 23.1%, p = 0.001) and during the 20-week follow-up periods. However, we did not detect any significant effects of TBS on the cytokine panels or any correlations between improvement in depressive symptoms and changes in serum inflammatory markers. Our findings provided the first evidence that the antidepressant efficacy of bilateral TBS monotherapy might not work via immune-modulating mechanisms.",2020,,['Major Depression'],['Bilateral Theta Burst Stimulation Monotherapy'],[],"[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",[],,0.446696,,"[{'ForeName': 'Po-Han', 'Initials': 'PH', 'LastName': 'Chou', 'Affiliation': 'Department of Psychiatry, China Medical University Hsinchu Hospital, China Medical University, Hsinchu, Taiwan; Department of Psychiatry, China Medical University Hospital, China Medical University, Taichung, Taiwan; Department of Biological Science and Technology, National Chiao Tung University, Hsinchu, Taiwan; Taiwan Allied Clinics for Integrative TMS, Taipei, Taiwan.'}, {'ForeName': 'Ming-Kuei', 'Initials': 'MK', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology, China Medical University Hospital, Taichung, Taiwan; College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chon-Haw', 'Initials': 'CH', 'LastName': 'Tsai', 'Affiliation': 'Department of Neurology, China Medical University Hospital, Taichung, Taiwan; College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Wan-Ting', 'Initials': 'WT', 'LastName': 'Hsieh', 'Affiliation': 'Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Hui-Chen', 'Initials': 'HC', 'LastName': 'Lai', 'Affiliation': 'Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Shityakov', 'Affiliation': 'Department of Psychiatry, China Medical University Hospital, China Medical University, Taichung, Taiwan; College of Medicine, China Medical University, Taichung, Taiwan; Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Kuan-Pin', 'Initials': 'KP', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry, China Medical University Hospital, China Medical University, Taichung, Taiwan; College of Medicine, China Medical University, Taichung, Taiwan; Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan; An-Nan Hospital, China Medical University, Tainan, Taiwan. Electronic address: cobolsu@gmail.com.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.06.024']
149,32528681,Dialectical behavior therapy adapted for binge eating compared to cognitive behavior therapy in obese adults with binge eating disorder: a controlled study.,"Background


Current guidelines recommend cognitive behavior therapy (CBT) as the treatment of choice for binge eating disorder (BED). Although CBT is quite effective, a substantial number of patients do not reach abstinence from binge eating. To tackle this problem, various theoretical conceptualizations and treatment models have been proposed. Dialectical behavior therapy (DBT), focusing on emotion regulation, is one such model. Preliminary evidence comparing DBT adapted for BED (DBT-BED) to CBT is promising but the available data do not favor one treatment over the other. The aim of this study is to evaluate outcome of DBT-BED, compared to a more intensive eating disorders-focused form of cognitive behavior therapy (CBT+), in individuals with BED who are overweight and engage in emotional eating.
Methods


Seventy-four obese patients with BED who reported above average levels of emotional eating were quasi-randomly allocated to one of two manualized 20-session group treatments: DBT-BED ( n  = 41) or CBT+ ( n  = 33). Intention-to-treat outcome was examined at post-treatment and at 6-month follow-up using general or generalized linear models with multiple imputation.
Results


Overall, greater improvements were observed in CBT+. Differences in number of objective binge eating episodes at end of treatment, and eating disorder psychopathology (EDE-Q Global score) and self-esteem (EDI-3 Low Self-Esteem) at follow-up reached statistical significance with medium effect sizes (Cohen's  d  between .46 and .59). Of the patients in the DBT group, 69.9% reached clinically significant change at end of the treatment vs 65.0% at follow-up. Although higher, this was not significantly different from the patients in the CBT+ group (52.9% vs 45.8%).
Conclusions


The results of this study show that CBT+ produces better outcomes than the less intensive DBT-BED on several measures. Yet, regardless of the dose-difference, the data suggest that DBT-BED and CBT+ lead to comparable levels of clinically meaningful change in global eating disorder psychopathology. Future recommendations include the need for dose-matched comparisons in a sufficiently powered randomized controlled trial, and the need to determine mediators and moderators of treatment outcome.
Trial registration


Nederlands Trial Register: NL3982 (NTR4154). Date of registration: 2013 August 28, retrospectively registered.",2020,The results of this study show that CBT+ produces better outcomes than the less intensive DBT-BED on several measures.,"['obese adults with binge eating disorder', 'individuals with BED who are overweight and engage in emotional eating', 'Methods\n\n\nSeventy-four obese patients with BED who reported above average levels of emotional eating']","['cognitive behavior therapy', 'Dialectical behavior therapy (DBT', 'CBT', 'Dialectical behavior therapy', 'DBT', 'DBT-BED', 'cognitive behavior therapy (CBT']","['CBT', 'global eating disorder psychopathology', 'number of objective binge eating episodes', 'eating disorder psychopathology (EDE-Q Global score) and self-esteem (EDI-3 Low Self-Esteem']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0679136', 'cui_str': 'Low self-esteem'}]",74.0,0.0996041,The results of this study show that CBT+ produces better outcomes than the less intensive DBT-BED on several measures.,"[{'ForeName': 'Mirjam W', 'Initials': 'MW', 'LastName': 'Lammers', 'Affiliation': 'Amarum, Expertise Centre for Eating Disorders, GGNet Network for Mental Health Care, Den Elterweg 75, 7207 AE Zutphen, The Netherlands.'}, {'ForeName': 'Maartje S', 'Initials': 'MS', 'LastName': 'Vroling', 'Affiliation': 'Amarum, Expertise Centre for Eating Disorders, GGNet Network for Mental Health Care, Den Elterweg 75, 7207 AE Zutphen, The Netherlands.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Sanford Center for Biobehavioral Research, Fargo, North Dakota USA.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'van Strien', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR Nijmegen, The Netherlands.'}]",Journal of eating disorders,['10.1186/s40337-020-00299-z']
150,32544914,Feasibility Study of a Docosahexaenoic Acid-Optimized Nutraceutical Formulation on the Macular Levels of Lutein in a Healthy Mediterranean Population.,"INTRODUCTION


Macular pigment optical density (MPOD) plays a pivotal role in maintaining macular structure and functioning. Research shows that daily consumption of lutein reduces the risk of eye diseases such as age-related macular degeneration.
OBJECTIVE


This study analyzes the influence of a supplementation containing lutein and antioxidant vitamins either with or without docosahexaenoic acid (DHA), with the main objective of identifying MPOD changes in both eyes at the end of the follow-up using the Visucam®retinograph. The secondary end point was to determine variation in the lutein and DHA levels in plasma and red blood cell membranes (RBCMs), respectively.
METHODS


One hundred healthy participants (200 eyes) aged 40-70 years (mean age 49.3 years, SEM = 13.7) were randomized in a 1:1 ratio to receive daily one of the following supplements for 3 months: lutein group (LT-G, n = 49) and lutein plus DHA group (LT/DHA-G, n = 51). The MPOD was measured at baseline and end of the follow-up by retinography (Visucam®retinograph). Lutein in plasma was determined by HPLC, and DHA in RBC membranes was analyzed by gas chromatograph/mass spectrometer.
RESULTS


From baseline, MPOD showed significantly higher values in the LT/DHA-G than in the LT-G at the end of the study (p < 0.0001). Significantly higher lutein in plasma (p < 0.0001) and DHA (p < 0.0001) levels in the RBC membrane were seen in the LT/DHA-G than in the LT-G at the 3-month follow-up.
CONCLUSION


Lutein supplementation improves MPOD in healthy subjects from a Mediterranean population being significantly increased in the presence of DHA. Therefore, our findings highlight the relevance of the adjunctive role of DHA for better lutein availability.",2021,"Significantly higher Lutein in plasma (p<0.0001) and DHA (p<0.0001) levels in the red blood cell membrane were seen in the Lutein/DHA group than in the Lutein group at the 3-month follow-up.
","['One hundred healthy participants (200 eyes) aged 40-70 years (mean age 49.3 years, SEM=13.7', 'healthy Mediterranean population', 'healthy subjects']","['Lutein/DHA', 'Lutein supplementation', 'docosahexaenoic acid optimized nutraceutical formulation', 'lutein', 'Lutein /Docosahexaenoic acid', 'supplementation containing lutein and antioxidant vitamins either with or without docosahexaenoic acid (DHA', 'Lutein']","['macular levels of lutein', 'Lutein in plasma', 'MPOD', 'Lutein in plasma (p<0.0001) and DHA (p<0.0001) levels in the red blood cell membrane', 'macular pigment optical density', 'lutein and DHA levels in plasma and red blood cell membranes respectively']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}]",100.0,0.166159,"Significantly higher Lutein in plasma (p<0.0001) and DHA (p<0.0001) levels in the red blood cell membrane were seen in the Lutein/DHA group than in the Lutein group at the 3-month follow-up.
","[{'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Zanón-Moreno', 'Affiliation': 'Ophthalmic Research Unit ""Santiago Grisolía"" FISABIO, and Cellular and Molecular Ophthalmobiology Group of the Department of Surgery at University of Valencia, Valencia, Spain.'}, {'ForeName': 'Joan C', 'Initials': 'JC', 'LastName': 'Domingo Pedrol', 'Affiliation': 'Department of Biochemistry and Molecular Biomedicine at the Faculty of Biology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Silvia M', 'Initials': 'SM', 'LastName': 'Sanz-González', 'Affiliation': 'Ophthalmic Research Unit ""Santiago Grisolía"" FISABIO, and Cellular and Molecular Ophthalmobiology Group of the Department of Surgery at University of Valencia, Valencia, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Raga-Cervera', 'Affiliation': 'Ophthalmic Research Unit ""Santiago Grisolía"" FISABIO, and Cellular and Molecular Ophthalmobiology Group of the Department of Surgery at University of Valencia, Valencia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Salazar-Corral', 'Affiliation': 'Spanish Network of Cooperative Research in Ophthalmology (OFTARED), Carlos III Health Institute, Ministry of Science, Innovation and Universities, Madrid, Spain.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Pinazo-Durán', 'Affiliation': 'Ophthalmic Research Unit ""Santiago Grisolía"" FISABIO, and Cellular and Molecular Ophthalmobiology Group of the Department of Surgery at University of Valencia, Valencia, Spain.'}]",Ophthalmic research,['10.1159/000509439']
151,32467635,Effects of different mydriatics on the choroidal vascularity in healthy subjects.,"PURPOSE


To evaluate choroidal vasculature changes after the instillation of mydriatic parasympatholytic and sympathomimetic agents in healthy subjects.
METHODS


A total of 95 healthy subjects were enrolled in this prospective, randomized comparative study. Study participants were divided into three different groups depending on the drug to be administered: tropicamide (1%) group (n = 31), tropicamide (0.5%) + phenylephrine (10%) group (n = 30) and control group receiving artificial tears (n = 34). All participants underwent a complete ophthalmological examination including best corrected visual acuity, refractive status and axial length. Subfoveal choroidal thickness (CT), total choroidal area (TCA), luminal and stromal choroidal area (LCA and SCA) and choroidal vascularity index (CVI) were measured before and after eye drops instillation.
RESULTS


All the baseline characteristics were matched between the three groups (all P > 0.05). Before the mydriatic instillation, there were no significant differences of CT, TCA, LA, SCA, and CVI among the three groups (all P > 0.05). After drug administration, CT, TCA, LCA, SCA, and CVI did not show any significant change as well (respectively, P = 0.265; P = 0.483; 0.573; P = 0.405 and P = 0.708).
CONCLUSIONS


Instillation of mydriatic eye drops did not induce significant changes of the choroidal vasculature, suggesting that their use do not alter CT and CVI evaluation.",2021,"After drug administration, CT, TCA, LCA, SCA, and CVI did not show any significant change as well (respectively, P = 0.265; P = 0.483; 0.573; P = 0.405 and P = 0.708).
","['95 healthy subjects', 'healthy subjects']","['tropicamide (0.5%)\u2009+\u2009phenylephrine', 'tropicamide', 'mydriatic parasympatholytic and sympathomimetic agents', 'control group receiving artificial tears']","['corrected visual acuity, refractive status and axial length', 'Subfoveal choroidal thickness (CT), total choroidal area (TCA), luminal and stromal choroidal area (LCA and SCA) and choroidal vascularity index (CVI', 'CT, TCA, LA, SCA, and CVI']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0041190', 'cui_str': 'Tropicamide'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0026964', 'cui_str': 'Mydriatic agent'}, {'cui': 'C0030511', 'cui_str': 'Parasympathetic-Blocking Agents'}, {'cui': 'C0039052', 'cui_str': 'Sympathomimetic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}]","[{'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0036056', 'cui_str': 'St. Lucia'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",95.0,0.0279034,"After drug administration, CT, TCA, LCA, SCA, and CVI did not show any significant change as well (respectively, P = 0.265; P = 0.483; 0.573; P = 0.405 and P = 0.708).
","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Iovino', 'Affiliation': 'Department of Surgical Sciences, Eye Clinic, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Chhablani', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Mohammed Abdul', 'Initials': 'MA', 'LastName': 'Rasheed', 'Affiliation': 'School of Optometry and Vision Science, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Tatti', 'Affiliation': 'Department of Surgical Sciences, Eye Clinic, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Bernabei', 'Affiliation': 'Ophthalmology Unit, S. Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pellegrini', 'Affiliation': 'Ophthalmology Unit, S. Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Giannaccare', 'Affiliation': 'Ophthalmology Unit, S. Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Peiretti', 'Affiliation': 'Department of Surgical Sciences, Eye Clinic, University of Cagliari, Cagliari, Italy. enripei@hotmail.com.'}]","Eye (London, England)",['10.1038/s41433-020-0995-9']
152,32445736,"A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial.","BACKGROUND


Excess gestational weight gain (GWG) among women with overweight or obesity synergistically increases their already elevated risk of having gestational diabetes, a caesarean delivery, a large for gestational age infant, and post-partum weight retention, and increases their child's risk of obesity. We investigated whether a primarily telehealth lifestyle intervention reduced excess GWG among women with overweight or obesity.
METHODS


We did a randomised controlled trial in five antenatal clinics of Kaiser Permanente; Oakland, San Leandro, Walnut Creek, Fremont, and Santa Clara, CA, USA. Women at 8-15 weeks' gestation with singletons, pre-pregnancy BMI 25·0-40·0 kg/m 2 , and aged 18 years or older were randomly assigned (1:1) to receive the telehealth lifestyle intervention or usual antenatal care. Randomisation was adaptively balanced for age, BMI, and race and ethnicity. Data collectors and investigators were masked to group assignments. The core lifestyle intervention consisted of two in-person and 11 telephone sessions on behavioural strategies to improve weight, diet, and physical activity, and stress management to help women meet a trial goal of gaining at the lower limit of the Institute of Medicine (IOM) guidelines range for total GWG: 7 kg for women with overweight and 5 kg for women with obesity. Usual antenatal care included an antenatal visit at 7-10 weeks' gestation, an additional seven antenatal visits, on average, and periodic health education newsletters, including the IOM GWG guidelines and information on healthy eating and physical activity in pregnancy. The primary outcome was weekly rate of GWG expressed as excess GWG, per Institute of Medicine guidelines and mean assessed in the intention-to-treat population. The trial is registered at ClinicalTrials.gov, NCT02130232.
FINDINGS


Between March 24, 2014, and Sept 26, 2017, 5329 women were assessed for eligibility and 200 were randomly assigned to the lifestyle intervention group and 198 to the usual care group. Analyses included 199 women in the lifestyle intervention group (one lost to follow-up) and 195 in the usual care group (three lost to follow-up). 96 (48%) women in the lifestyle intervention group and 134 (69%) women in the usual care group exceeded Institute of Medicine guidelines for rate of GWG per week (relative risk 0·70, 95% CI 0·59 to 0·83). Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32 kg per week [0·13]; mean between-group difference -0·07 kg per week, 95% CI -0·09 to -0·04). No between-group differences in perinatal complications were observed.
INTERPRETATION


Our evidence-based programme showed that health-care delivery systems could further adapt to meet the needs of their clinical settings to prevent excess GWG and improve healthy behaviours and markers of insulin resistance among women with overweight or obesity by using telehealth lifestyle interventions.
FUNDING


US National Institutes of Health.",2020,"Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32","[""Women at 8-15 weeks' gestation with singletons, pre-pregnancy BMI 25·0-40·0 kg/m 2 , and aged 18 years or older"", 'women with overweight and 5 kg for women with obesity', '199 women in the lifestyle intervention group (one lost to follow-up) and 195 in the usual care group (three lost to follow-up', 'five antenatal clinics of Kaiser Permanente; Oakland, San Leandro, Walnut Creek, Fremont, and Santa Clara, CA, USA', 'women with overweight or obesity', 'women in the lifestyle intervention group and 134 (69%) women in the usual care group exceeded Institute of Medicine guidelines for rate of GWG per week (relative risk 0·70, 95% CI 0·59 to 0·83', 'women with overweight or obesity by using telehealth lifestyle interventions', 'pregnant women with overweight or obesity (GLOW', 'Between March 24, 2014, and Sept 26, 2017, 5329 women were assessed for eligibility and 200 were randomly assigned to the lifestyle intervention group and 198 to the usual care group']","['telehealth lifestyle intervention or usual antenatal care', 'telephone sessions on behavioural strategies to improve weight, diet, and physical activity, and stress management to help women meet a trial goal of gaining at the lower limit of the Institute of Medicine (IOM) guidelines range for total GWG', ""Usual antenatal care included an antenatal visit at 7-10 weeks' gestation, an additional seven antenatal visits, on average, and periodic health education newsletters, including the IOM GWG guidelines and information"", 'primarily telehealth lifestyle intervention', 'telehealth lifestyle intervention']","['perinatal complications', 'weekly rate of GWG', 'weekly rate of GWG expressed as excess GWG, per Institute of Medicine guidelines and mean assessed in the intention-to-treat population', 'gestational weight gain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0330971', 'cui_str': 'Juglans'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4748924', 'cui_str': 'Global developmental delay, lung cysts, overgrowth, Wilms tumor syndrome'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}]","[{'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",5329.0,0.152039,"Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32","[{'ForeName': 'Assiamira', 'Initials': 'A', 'LastName': 'Ferrara', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA. Electronic address: assiamira.ferrara@kp.org.'}, {'ForeName': 'Monique M', 'Initials': 'MM', 'LastName': 'Hedderson', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Brown', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA; Department of Internal Medicine, School of Medicine, University of California, Davis, Sacramento, CA, USA.'}, {'ForeName': 'Samantha F', 'Initials': 'SF', 'LastName': 'Ehrlich', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA; Department of Public Health, University of Tennessee Knoxville, Knoxville, TN, USA.'}, {'ForeName': 'Ai-Lin', 'Initials': 'AL', 'LastName': 'Tsai', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Juanran', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Galarce', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Santica', 'Initials': 'S', 'LastName': 'Marcovina', 'Affiliation': 'Northwest Lipid Metabolism and Diabetes Research Laboratories, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Catalano', 'Affiliation': 'Mother Infant Research Institute, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Quesenberry', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30107-8']
153,32540325,Risk Factors for Visual Field Deterioration in the United Kingdom Glaucoma Treatment Study.,"PURPOSE


The United Kingdom Glaucoma Treatment Study (UKGTS) investigated the visual field (VF)-preserving effect of medical treatment in open-angle glaucoma (OAG). The objective of this analysis was to identify risk factors associated with VF deterioration.
DESIGN


Randomized, double-masked, placebo-controlled multicenter trial.
PARTICIPANTS


Five hundred sixteen participants with previously untreated OAG were recruited prospectively in 10 United Kingdom centers.
METHODS


Eligibility criteria were modeled on those for the Early Manifest Glaucoma Trial. Study participants were randomized to either latanoprost 0.005% or placebo eye drops. The observation period was 2 years and involved, among other procedures, VF testing and intraocular pressure (IOP) measurement at 11 scheduled visits, with clustering of tests at baseline, 18 months, and 24 months. Guided progression analysis pattern deviation maps were used to determine VF deterioration. Cox regression was used to compute the hazard ratios (HRs) and respective 95% confidence intervals (CIs) while accounting for the correlation within sites. Model selection was guided by backward stepwise selection conducted on the model containing all variables that were significant at the 0.2 level in the univariate analysis. Follow-up variables that showed collinearity with baseline values were not retained in the final model.
MAIN OUTCOME MEASURE


Time to VF deterioration.
RESULTS


Treatment with latanoprost reduced the HR, for VF deterioration by 58% (HR, 0.42; 95% CI, 0.27-0.67; P = 0.001). Factors associated with deterioration were bilateral disease (HR, 1.59 for yes vs. no; 95% CI, 1.02-2.50; P = 0.041), higher baseline IOP (HR, 1.07 per mmHg; 95% CI, 1.02-1.12; P = 0.008), and disc hemorrhage at visit 1 (HR, 2.08; 95% CI, 1.07-4.04; P = 0.030). Smoking (current or previous) was associated with a reduced HR, for VF deterioration (HR, 0.59; 95% CI, 0.37-0.93; P = 0.023). No other evaluated factors were found to be statistically significant in the multivariable analysis.
CONCLUSIONS


In the UKGTS, treatment with latanoprost halved VF deterioration risk. Bilateral disease, higher IOP, and disc hemorrhage were confirmed as risk factors for deterioration; smoking history seemed to be protective against VF deterioration.",2020,"Bilateral disease, higher IOP and disc haemorrhage were confirmed as risk factors for deterioration; smoking history appeared to be protective against VF deterioration.","['Eligibility criteria were modeled on those for the Early Manifest Glaucoma Trial', 'open-angle glaucoma (OAG', 'Five hundred sixteen participants with previously untreated OAG were prospectively recruited in 10 UK centres']","['latanoprost', 'placebo']","['bilateral disease', 'higher baseline IOP', 'disc haemorrhage', 'Time-to-VF deterioration', 'Bilateral disease, higher IOP and disc haemorrhage', 'VF deterioration risk', 'VF testing and intraocular pressure (IOP) measurement', 'reduced HR for VF deterioration', 'HR for VF deterioration']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042825', 'cui_str': 'Visual field study'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",516.0,0.300799,"Bilateral disease, higher IOP and disc haemorrhage were confirmed as risk factors for deterioration; smoking history appeared to be protective against VF deterioration.","[{'ForeName': 'Panayiota', 'Initials': 'P', 'LastName': 'Founti', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom. Electronic address: pfounti@gmail.com.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': ""National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom; King's College London, London School of Hygiene & Tropical Medicine, London, United Kingdom.""}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Khawaja', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': 'Comprehensive Clinical Trials Unit at University College London, London, United Kingdom.'}, {'ForeName': 'Jibran', 'Initials': 'J', 'LastName': 'Mohamed-Noriega', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Garway-Heath', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.06.009']
154,32561467,A randomized comparison trial of culturally adapted HIV prevention approaches for Native Americans reducing trauma symptoms versus substance misuse: The Healing Seasons protocol.,"Native Americans (NA) experience interrelated risks of trauma exposure, substance use, and HIV risk behaviors that put them at increased risk for HIV infection. Despite these known risk factors, there are very few published randomized trials testing interventions to reduce trauma-related symptoms and substance misuse among NA.
METHODS


The Healing Seasons study is a randomized comparsion trial of two counseling strategies, Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST) addressing substance misuse as a means to prevent HIV among NA. Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies. Participants, 16 years and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person, and randomized in equal numbers to NET or MIST. We stratified by age (16-29 years and 30 or older) and gender (male or female identified) to ensure balance between treatment arms. The primary outcomes were number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity.
DISCUSSION


Behavioral interventions for NA are needed to prevent HIV risk behaviors when faced with trauma symptoms and substance misuse. This study will provide evidence to determine feasibility and efficacy of addressing related risk factors as part of counseling-based HIV prevention intervention to reduce sexual risk among this population.
TRIAL REGISTRATION


ClinicalTrials.gov number, NCT03112369, registered April 12, 2017.",2020,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","['Native Americans reducing trauma symptoms versus substance misuse', 'We stratified by age (16-29\u202fyears and 30 or older) and gender (male or female identified', 'Participants, 16\u202fyears and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person']","['NET or MIST', 'culturally adapted HIV prevention approaches', 'Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST', 'counseling-based HIV prevention intervention']","['number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity', 'HIV risk behaviors']","[{'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030170', 'cui_str': 'Pacific Northwest'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0757073,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Pearson', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA. Electronic address: pearsonc@uw.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kaysen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Huh', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bedard-Gillgan', 'Affiliation': 'Department of Psychiatry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Innovative Programs Research Group, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marin', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Saluskin', 'Affiliation': 'Yakama Nation Behavioral Health Services, Toppenish, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106070']
155,32573284,Participant expectations and experiences of a tailored physiotherapy intervention for people with Parkinson's and a history of falls.,"PURPOSE


People with Parkinson's are twice as likely to fall as older people within the general population. This longitudinal qualitative study was part of a larger programme of research including a randomised controlled trial to test the effectiveness of a tailored physiotherapy intervention. Specific qualitative aims focused on a subsample of trial participants in the intervention arm of the trial, and comprised the following:To explore the expectations of participants about the intervention.To investigate participants' experiences of the intervention, and its perceived impacts.To understand the facilitators and barriers to engagement.
METHODS


Two semi-structured interviews were completed with a theoretical sample of people with Parkinson's from the intervention arm, initially after randomisation but before the intervention commenced, and then again six months later.
RESULTS


Forty-two participants out of a large clinical trial were interviewed initially, with 37 agreeing to a second interview at six months. Prior experience of rehabilitation plus information accessed through the trial consent procedure informed participants' realistic expectations. Most found the level of the intervention acceptable, and perceived a range of benefits. However, views about equipment provided were more equivocal. The biggest barriers to participation were time and motivation, whilst social support facilitated engagement with the intervention.
CONCLUSIONS


This study is the first to capture expectations about participation in a programme of exercises and strategies. It highlights that previous challenges to engagement in physical exercises and activities are not a barrier to future participation and provides new insights into the role of equipment and technology in programmes of physical activity for people with Parkinson's. The challenge of ensuring that programmes of exercise and strategies become an embedded feature of everyday life is highlighted, particularly alongside busy social engagements and leisure pursuits.Implications for rehabilitationFor people with Parkinsons, a programme of exercises and strategies has the potential to reduce the risk of falls amongst those with a history of falling.Adherence to such programmes can prove challenging for a variety of reasons, even when participants have realistic expectations about the commitment and effort needed.Clear explanations about the role of equipment and technology within such programmes could enhance adherence.In order to further individualise programmes of exercise for people with Parkinsons, choice regarding social support, reminders and integration into everyday activities should be explored.",2022,This longitudinal qualitative study was part of a larger programme of research including a randomised controlled trial to test the effectiveness of a tailored physiotherapy intervention.,"['older people within the general population', 'rehabilitationFor people with Parkinsons', ""people with Parkinson's"", ""people with Parkinson's and a history of falls"", 'Results:  Forty-two participants out of a large clinical trial were interviewed initially, with 37 agreeing to a second interview at six months']",['tailored physiotherapy intervention'],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],42.0,0.0346235,This longitudinal qualitative study was part of a larger programme of research including a randomised controlled trial to test the effectiveness of a tailored physiotherapy intervention.,"[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Rowsell', 'Affiliation': 'Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Ashburn', 'Affiliation': 'Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Fitton', 'Affiliation': 'Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Goodwin', 'Affiliation': 'Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Hulbert', 'Affiliation': 'Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Institute for Health Research, University of Exeter, Exeter, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McIntosh', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Nieuwboer', 'Affiliation': 'Rehabilitation Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Pickering', 'Affiliation': 'Biomedical Research Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'Translational and Clinical Research Institute, University of Newcastle, Newcastle, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Chivers-Seymour', 'Affiliation': 'Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Ballinger', 'Affiliation': 'Biomedical Research Centre, University of Southampton, Southampton, UK.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1779824']
156,32445077,Outcomes of ketorolac versus depomedrol infiltrations for subacromial impingement syndrome: a randomized controlled trial.,"PURPOSE


Local subacromial infiltration with steroids is a common method of treatment of subacromial impingement syndrome. However, the use of steroids has concerns like tendon rupture, articular cartilage changes and infections. Local NSAIDs infiltration has recently been tried in literature. This study compares the effect of subacromial injections of ketorolac with steroids.
METHODS


A randomized controlled study was planned with 35 patients in each group. Patients in group-1 were infiltrated with subacromial ketorolac (60 mg with 2% lignocaine) and in group-2 with a steroid (methylprednisolone-40 mg with 2% lignocaine). A similar rehabilitation protocol was followed, and clinical outcomes were analyzed using visual analog scale (VAS) for pain and shoulder pain and disability score (SPADI) and range of motion at one-month and three-months follow-up.
RESULTS


Total data of 67 patients were analyzed, as three patients were lost to follow-up. In group 1, mean VAS improved from 7.9 [Formula: see text] 0.95 to 3.19 [Formula: see text] 0.81 (p < 0.001) and SPADI improved from 61.41 [Formula: see text] 11.86 to 28.91 [Formula: see text] 9.06 (p < 0.001) at three months, respectively. In group 2, mean VAS improved from 8.05 [Formula: see text] 0.94 to 2.9 [Formula: see text] 0.64 (p < 0.001) and SPADI improved from 63.45 [Formula: see text] 9.64 to 25.32 [Formula: see text] 6.87 (p < 0.001) at three months, respectively. However, there were no differences in functional outcomes between the groups (p = 0.21 for VAS, p = 0.16 for SPADI).
CONCLUSION


Subacromial ketorolac infiltration has an equivalent outcome as that of steroid infiltration. Ketorolac could be considered as a reasonable alternative to steroids in cases where it is contraindicated.",2022,"However, there were no differences in functional outcomes between the groups (p = 0.21 for VAS, p = 0.16 for SPADI).
","['subacromial impingement syndrome', '35 patients in each group']","['Ketorolac', 'steroid (methylprednisolone-40\xa0mg with 2% lignocaine', 'steroids', 'ketorolac', 'lignocaine', 'subacromial ketorolac', 'ketorolac with steroids']","['functional outcomes', 'SPADI', 'mean VAS', 'visual analog scale (VAS) for pain and shoulder pain and disability score (SPADI) and range of motion']","[{'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C1125541', 'cui_str': 'Methylprednisolone 40 MG'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",67.0,0.0689275,"However, there were no differences in functional outcomes between the groups (p = 0.21 for VAS, p = 0.16 for SPADI).
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Goyal', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, AIIMS, Virbhadra Marg, Rishikesh, Uttarakhand, 249201, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, AIIMS, Virbhadra Marg, Rishikesh, Uttarakhand, 249201, India.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Sethy', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, AIIMS, Virbhadra Marg, Rishikesh, Uttarakhand, 249201, India. sekhar.ciddharth@gmail.com.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Choudhury', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, AIIMS, Virbhadra Marg, Rishikesh, Uttarakhand, 249201, India.'}]",Musculoskeletal surgery,['10.1007/s12306-020-00667-7']
157,32488909,Immune phenotype of tumor microenvironment predicts response to bevacizumab in neoadjuvant treatment of ER-positive breast cancer.,"Antiangiogenic drugs are potentially a useful supplement to neoadjuvant chemotherapy for a subgroup of patients with human epidermal growth factor receptor 2 (HER2) negative breast cancer, but reliable biomarkers for improved response are lacking. Here, we report on a randomized phase II clinical trial to study the added effect of bevacizumab in neoadjuvant chemotherapy with FEC100 (5-fluorouracil, epirubicin and cyclophosphamide) and taxanes (n = 132 patients). Gene expression from the tumors was obtained before neoadjuvant treatment, and treatment response was evaluated by residual cancer burden (RCB) at time of surgery. Bevacizumab increased the proportion of complete responders (RCB class 0) from 5% to 20% among patients with estrogen receptor (ER) positive tumors (P = .02). Treatment with bevacizumab was associated with improved 8-year disease-free survival (P = .03) among the good responders (RCB class 0 or I). Patients treated with paclitaxel (n = 45) responded better than those treated with docetaxel (n = 21; P = .03). Improved treatment response was associated with higher proliferation rate and an immune phenotype characterized by high presence of classically activated M1 macrophages, activated NK cells and memory activated CD4 T cells. Treatment with bevacizumab increased the number of adverse events, including hemorrhage, hypertension, infection and febrile neutropenia, but despite this, the ECOG status was not affected.",2020,"Improved treatment response was associated with higher proliferation rate and an immune phenotype characterized by high presence of classically activated M1 macrophages, activated NK cells and memory activated CD4 T-cells.","['n =\u2009132 patients', 'ER positive breast cancer']","['docetaxel', 'paclitaxel', 'Bevacizumab', 'FEC100 (5-fluorouracil, epirubicin and cyclophosphamide) and taxanes', 'bevacizumab']","['number of adverse events, including hemorrhage, hypertension, infection and febrile neutropenia', 'proportion of complete responders (RCB class 0', 'eight year disease free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2938924', 'cui_str': 'Oestrogen receptor positive breast cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2919268', 'cui_str': 'Residual cancer burden class'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",132.0,0.0215363,"Improved treatment response was associated with higher proliferation rate and an immune phenotype characterized by high presence of classically activated M1 macrophages, activated NK cells and memory activated CD4 T-cells.","[{'ForeName': 'Hedda', 'Initials': 'H', 'LastName': 'von der Lippe Gythfeldt', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Tonje', 'Initials': 'T', 'LastName': 'Lien', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Tekpli', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Laxmi', 'Initials': 'L', 'LastName': 'Silwal-Pandit', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Borgen', 'Affiliation': 'Department of Pathology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Garred', 'Affiliation': 'Department of Pathology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Skjerven', 'Affiliation': 'Department of Breast and Endocrine Surgery, Drammen Hospital, Vestre Viken Hospital Trust, Drammen, Norway.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Schlichting', 'Affiliation': 'Department of Breast and Endocrine Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Steinar', 'Initials': 'S', 'LastName': 'Lundgren', 'Affiliation': 'Department of Oncology, St. Olavs University Hospital, Trondheim, Norway.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Wist', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Naume', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Vessela', 'Initials': 'V', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anne-Lise', 'Initials': 'AL', 'LastName': 'Børresen-Dale', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ole Christian', 'Initials': 'OC', 'LastName': 'Lingjaerde', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Engebraaten', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}]",International journal of cancer,['10.1002/ijc.33108']
158,33070667,A randomized controlled trial of cognitive behavioral therapy compared with diabetes education for diabetic peripheral neuropathic pain.,"A randomized controlled trial compared cognitive behavioral therapy (CBT) and diabetes education (ED) as an adjunctive treatment for diabetic peripheral neuropathic pain (DPNP). We examined change from baseline to 12- and 36-week follow-up in overall pain intensity (NRS), neuropathic pain intensity/quality, pain interference, and mental health functioning, among others. Although CBT participants demonstrated improvement in pain intensity NRS, there were no between-condition differences at either follow-up. CBT reduced neuropathic pain intensity at 12-weeks more than ED. At 36-weeks, CBT was superior to ED for improving pain interference and mental health functioning. Results provide evidence of benefit of CBT for DPNP. ClinicalTrials.gov Identifier : NCT00830011.",2022,"Although CBT participants demonstrated improvement in pain intensity NRS, there were no between-condition differences at either follow-up.","['diabetic peripheral neuropathic pain (DPNP', 'diabetic peripheral neuropathic pain']","['CBT', 'diabetes education', 'cognitive behavioral therapy (CBT) and diabetes education (ED', 'cognitive behavioral therapy']","['overall pain intensity (NRS), neuropathic pain intensity/quality, pain interference, and mental health functioning', 'pain intensity NRS', 'pain interference and mental health functioning', 'neuropathic pain intensity']","[{'cui': 'C1963916', 'cui_str': 'Diabetic peripheral neuropathic pain'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.216478,"Although CBT participants demonstrated improvement in pain intensity NRS, there were no between-condition differences at either follow-up.","[{'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Higgins', 'Affiliation': 'VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Alicia A', 'Initials': 'AA', 'LastName': 'Heapy', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Buta', 'Affiliation': 'Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'LaChappelle', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Serowik', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Czlapinski', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Kerns', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, CT, USA.'}]",Journal of health psychology,['10.1177/1359105320962262']
159,32622071,Delta-like 1 (DLK1) is a possible mediator of vitamin D effects on bone and energy metabolism.,"Vitamin D effects on bone and mineral metabolism are well recognized, and its anti-inflammatory actions are gaining particular interest. Delta-like 1 (DLK1) is a protein, expressed by progenitor cells of different tissues, and increases the size of progenitor cell population during the inflammatory phase of tissue regeneration. DLK1 also plays a role in energy metabolism as it antagonizes insulin signaling in bone. In this one-year randomized clinical trial of overweight elderly individuals that received either 600 or 3750 IU daily cholecalciferol we assessed the effect of vitamin D supplementation on pre-specified secondary outcomes: DLK1, leptin, adiponectin, C-Reactive Protein (CRP) and Vascular Cell Adhesion Molecule (VCAM). We also examined correlations between DLK1 and bone (BMD, bone markers), fat (adipokines, body composition), insulin sensitivity and inflammatory markers. Multivariate analyses were conducted to further explore these associations. Overall, there was a significant increase in serum DLK1 and leptin and a decrease in VCAM, but no change in CRP, after 12 months of vitamin D supplementation. DLK1 was negatively correlated with BMD and positively correlated with bone markers, associations that persisted after adjusting for age, gender and BMI. DLK1 was also positively associated with indices of insulin resistance and negatively with indices of insulin sensitivity. Correlations between DLK1 and fat parameters, such as adipokines, and DXA derived fat mass were less consistent. There were no correlations between DLK1 and inflammatory markers. In conclusion, twelve months supplementation of vitamin D3 increased serum DLK1. DLK1 was negatively associated with indices of bone health and fuel metabolism, and with 1,25(OH) 2 D levels. Similar to the role of DLK1 in animal models, our findings support the hypothesis that DLK1 can be targeted to regulate bone and energy metabolism and develop drugs to improve BMD and insulin sensitivity. However, further studies are needed to explore the role of DLK1 and its relationship to vitamin D metabolites in vivo.",2020,"Correlations between DLK1 and fat parameters, such as adipokines, and DXA derived fat mass were less consistent.",['overweight elderly individuals'],"['Vitamin D', 'Delta-like 1 (DLK1', '600 or 3750\u202fIU daily cholecalciferol', 'vitamin D supplementation', 'vitamin D3']","['bone health and fuel metabolism, and with 1,25(OH) 2 D levels', 'serum DLK1 and leptin', 'serum DLK1', 'DLK1 and inflammatory markers', 'DLK1', 'BMD and insulin sensitivity', 'leptin, adiponectin, C-Reactive Protein (CRP) and Vascular Cell Adhesion Molecule (VCAM', 'VCAM', 'DLK1and bone (BMD, bone markers), fat (adipokines, body composition), insulin sensitivity and inflammatory markers', 'bone and mineral metabolism', 'insulin resistance and negatively with indices of insulin sensitivity']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517746', 'cui_str': '3750'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0714769,"Correlations between DLK1 and fat parameters, such as adipokines, and DXA derived fat mass were less consistent.","[{'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Bassatne', 'Affiliation': 'Calcium Metabolism and Osteoporosis Program, Division of Endocrinology and Metabolism, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Jafari', 'Affiliation': 'Molecular Endocrinology and Stem Cell Research Unit (KMEB), Department of Endocrinology and Metabolism, Odense University Hospital and Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Cellular and Molecular Medicine, Novo Nordisk Foundation Center for Stem Cell Biology (DanStem), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Moustapha', 'Initials': 'M', 'LastName': 'Kassem', 'Affiliation': 'Molecular Endocrinology and Stem Cell Research Unit (KMEB), Department of Endocrinology and Metabolism, Odense University Hospital and Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Rahme', 'Affiliation': 'Calcium Metabolism and Osteoporosis Program, Division of Endocrinology and Metabolism, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'El-Hajj Fuleihan', 'Affiliation': 'Calcium Metabolism and Osteoporosis Program, Division of Endocrinology and Metabolism, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address: gf01@aub.edu.lb.'}]",Bone,['10.1016/j.bone.2020.115510']
160,32613525,Development and Initial Testing of an mHealth Transitions of Care Intervention for Adults with Schizophrenia-Spectrum Disorders Immediately Following a Psychiatric Hospitalization.,"An important period in the care of patients with schizophrenia-spectrum disorders is when they transition from inpatient to outpatient services and are at increased risk for relapse and rehospitalization. Thus, we developed and examined the initial feasibility, acceptability, and clinical effects of an mHealth transitions of care intervention (Mobile After-Care Support; MACS) in an open trial. Ten adults with schizophrenia-spectrum disorders were recruited during their index psychiatric hospitalization and enrolled prior to discharge. Measures of feasibility, acceptability, and MACS targets were administered at baseline and a 1-month follow-up. Drawing on skills from Cognitive Behavioral Therapy for Psychosis (CBTp), MACS delivered brief assessments of clinically relevant variables, followed by just-in-time interventions for patients starting immediately post-discharge. Individuals completed about one session per day on average as expected. Overall, measures of MACS usability and satisfaction were positive. T-test analyses showed that dysfunctional coping strategies significantly decreased from baseline to 1-month follow-up. Results also revealed statistically significant reductions in psychiatric symptoms over 1-month follow-up. This study demonstrates the feasibility and acceptability of MACS, a new app-based intervention targeting transitions of care for patients with psychosis. The field is turning to the use of mobile technology as a means of augmenting service delivery and providing real-time assessment and intervention for patients at risk. MACS is a promising adjunctive intervention that warrants further testing in a randomized controlled trial.",2021,"This study demonstrates the feasibility and acceptability of MACS, a new app-based intervention targeting transitions of care for patients with psychosis.","['patients with schizophrenia-spectrum disorders', 'Ten adults with schizophrenia-spectrum disorders were recruited during their index psychiatric hospitalization and enrolled prior to discharge', 'patients with psychosis', 'Adults with Schizophrenia-Spectrum Disorders']","['MACS', 'Care Intervention', 'care intervention (Mobile After-Care Support; MACS']","['dysfunctional coping strategies', 'psychiatric symptoms', 'feasibility, acceptability, and MACS targets', 'MACS usability and satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",10.0,0.0587841,"This study demonstrates the feasibility and acceptability of MACS, a new app-based intervention targeting transitions of care for patients with psychosis.","[{'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Moitra', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, 02912, USA. ethan_moitra@brown.edu.'}, {'ForeName': 'Hyun Seon', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Psychosocial Research Program, Butler Hospital, Providence, RI, 02906, USA.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Gaudiano', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, 02912, USA.'}]",The Psychiatric quarterly,['10.1007/s11126-020-09792-9']
161,32610815,Using Open Public Meetings and Elections to Promote Inward Transparency and Accountability: Lessons From Zambia.,"BACKGROUND


Community-led governance can ensure that leaders are accountable to the populations they serve and strengthen health systems for maternal care. A key aspect of democratic accountability is electing respective governance bodies, in this case community boards, and holding public meetings to inform community members about actions taken on their behalf. After helping build and open 10 maternity waiting homes (MWHs) in rural Zambia as part of a randomized controlled trial, we assisted community governance committees to plan and execute annual meetings to present performance results and, where needed, to elect new board members.
METHODS


We applied a principally qualitative design using observation and analysis of written documentation of public meetings to answer our research question: how do governance committees enact inward transparency and demonstrate accountability to their communities. The analysis measured participation and stakeholder representation at public meetings, the types and purposes of accountability sought by community members as evidenced by questions asked of the governance committee, and responsiveness of the governance committee to issues raised at public meetings.
RESULTS


Public meetings were attended by 6 out of 7 possible stakeholder groups, and reports were generally transparent. Stakeholders asked probing questions focused mainly on financial performance. Governance committee members were responsive to questions raised by participants, with 59% of answers rated as fully or mostly responsive (showing understanding of and answering the question). Six of the 10 sites held elections to re-elect or replace governance committee members. Only 2 sites reached the target set by local stakeholder committees of 50% female membership, down from 3 at formation. To further improve transparency and accountability, community governance committees need to engage in advance preparation of reports, and should consult with stakeholders on broader measures for performance assessment. Despite receiving training, community-level governance committees lacked understanding of the strategic purpose of open public meetings and elections, and how these relate to democratic accountability. They were therefore not motivated to engage in tactics to manage stakeholders effectively.
CONCLUSION


While open meetings and elections have potential to enhance good governance at the community level, continuous training and mentoring are needed to build capacity and enhance sustainability.",2022,"Governance committee members were responsive to questions raised by participants, with 59% of answers rated as fully or mostly responsive (showing understanding of and answering the question).",['10 maternity waiting homes (MWHs) in rural Zambia'],[],[],"[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}]",[],[],,0.0274592,"Governance committee members were responsive to questions raised by participants, with 59% of answers rated as fully or mostly responsive (showing understanding of and answering the question).","[{'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Vian', 'Affiliation': 'School of Nursing and Health Professions, University of San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Fong', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Jeanette L', 'Initials': 'JL', 'LastName': 'Kaiser', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Misheck', 'Initials': 'M', 'LastName': 'Bwalya', 'Affiliation': 'Department of Research, Right to Care Zambia, Lusaka, Zambia.'}, {'ForeName': 'Viviane I R', 'Initials': 'VIR', 'LastName': 'Sakanga', 'Affiliation': 'Department of Programs, Amref Health Africa, Lusaka, Zambia.'}, {'ForeName': 'Thandiwe', 'Initials': 'T', 'LastName': 'Ngoma', 'Affiliation': 'Department of Research, Right to Care Zambia, Lusaka, Zambia.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Scott', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}]",International journal of health policy and management,['10.34172/ijhpm.2020.84']
162,32605396,Physical activity and posttraumatic growth in patients receiving maintenance hemodialysis: A prospective study.,"This study used a prospective design to examine the association between self-reported physical activity and posttraumatic growth (PTG) over a 1-year period among 150 patients receiving maintenance hemodialysis. Transport-related, household, and leisure-time physical activity were positively associated with PTG at baseline and follow-up. Total physical activity could predict higher levels of PTG at follow-up, after controlling for baseline PTG and other covariates. The findings indicate that daily physical activity could be a modifiable behavioral factor associated with PTG among patients receiving maintenance hemodialysis. Further study is needed using a randomized controlled design and objective measures of physical activity.",2021,"Total physical activity could predict higher levels of PTG at follow-up, after controlling for baseline PTG and other covariates.","['patients receiving maintenance hemodialysis', '150 patients receiving maintenance hemodialysis']",['physical activity and posttraumatic growth (PTG'],"['Physical activity and posttraumatic growth', 'Total physical activity', 'Transport-related, household, and leisure-time physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}]",150.0,0.0105793,"Total physical activity could predict higher levels of PTG at follow-up, after controlling for baseline PTG and other covariates.","[{'ForeName': 'Jieling', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'The University of Hong Kong, China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Shanghai Chang Zheng Hospital, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Shanghai Chang Zheng Hospital, China.'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Shi Bei Hospital, China.'}, {'ForeName': 'Bibo', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Zha Bei Dsitrict Center Hospital of Shanghai, China.'}, {'ForeName': 'Jingfen', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Jiao Tong University School of Medicine, China.'}, {'ForeName': 'Vivian Wq', 'Initials': 'VW', 'LastName': 'Lou', 'Affiliation': 'The University of Hong Kong, China.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Shanghai Jiao Tong University School of Medicine, China.'}]",Journal of health psychology,['10.1177/1359105320937056']
163,32678879,"CODEL: phase III study of RT, RT + TMZ, or TMZ for newly diagnosed 1p/19q codeleted oligodendroglioma. Analysis from the initial study design.","BACKGROUND


We report the analysis involving patients treated on the initial CODEL design.
METHODS


Adults (>18) with newly diagnosed 1p/19q World Health Organization (WHO) grade III oligodendroglioma were randomized to radiotherapy (RT; 5940 centigray ) alone (arm A); RT with concomitant and adjuvant temozolomide (TMZ) (arm B); or TMZ alone (arm C). Primary endpoint was overall survival (OS), arm A versus B. Secondary comparisons were performed for OS and progression-free survival (PFS), comparing pooled RT arms versus TMZ-alone arm.
RESULTS


Thirty-six patients were randomized equally. At median follow-up of 7.5 years, 83.3% (10/12) TMZ-alone patients progressed, versus 37.5% (9/24) on the RT arms. PFS was significantly shorter in TMZ-alone patients compared with RT patients (hazard ratio [HR] = 3.12; 95% CI: 1.26, 7.69; P = 0.014). Death from disease progression occurred in 3/12 (25%) of TMZ-alone patients and 4/24 (16.7%) on the RT arms. OS did not statistically differ between arms (comparison underpowered). After adjustment for isocitrate dehydrogenase (IDH) status (mutated/wildtype) in a Cox regression model utilizing IDH and RT treatment status as covariables (arm C vs pooled arms A + B), PFS remained shorter for patients not receiving RT (HR = 3.33; 95% CI: 1.31, 8.45; P = 0.011), but not OS ((HR = 2.78; 95% CI: 0.58, 13.22, P = 0.20). Grade 3+ adverse events occurred in 25%, 42%, and 33% of patients (arms A, B, and C). There were no differences between arms in neurocognitive decline comparing baseline to 3 months.
CONCLUSIONS


TMZ-alone patients experienced significantly shorter PFS than patients treated on the RT arms. The ongoing CODEL trial has been redesigned to compare RT + PCV versus RT + TMZ.",2021,"Arm A versus B. Secondary comparisons were performed for OS and progression-free survival (PFS), comparing pooled RT arms versus TMZ-alone arm.
","['newly-diagnosed\xa01p/19q', 'Thirty-six patients', 'patients treated on\xa0the initial CODEL design', 'Adults (>18) with newly-diagnosed 1p/19q WHO grade III oligodendroglioma were randomized to RT (5940 cGy) alone (Arm A']","['TMZ', 'RT with concomitant and adjuvant temozolomide (TMZ) (Arm B); or TMZ', 'RT, RT + Temozolomide (TMZ), or TMZ', 'RT+PCV versus RT+TMZ']","['PFS', 'OS', 'Grade 3+ adverse events', 'OS and progression-free survival (PFS', 'neurocognitive decline', 'Death from disease progression', 'overall survival (OS']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0028945', 'cui_str': 'Oligodendroglioma, no ICD-O subtype'}, {'cui': 'C0556645', 'cui_str': 'cGy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",36.0,0.0848083,"Arm A versus B. Secondary comparisons were performed for OS and progression-free survival (PFS), comparing pooled RT arms versus TMZ-alone arm.
","[{'ForeName': 'Kurt A', 'Initials': 'KA', 'LastName': 'Jaeckle', 'Affiliation': 'Department of Neurology, Mayo Clinic Florida, Jacksonville, Florida, USA.'}, {'ForeName': 'Karla V', 'Initials': 'KV', 'LastName': 'Ballman', 'Affiliation': 'Alliance Statistics and Data Center, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'van den Bent', 'Affiliation': 'Brain Tumor Center, Erasmus MC Cancer Center, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Giannini', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Galanis', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Brown', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Jenkins', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'J Gregory', 'Initials': 'JG', 'LastName': 'Cairncross', 'Affiliation': 'Department of Clinical Neurosciences, Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Neurologische Klinik, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Kenneth D', 'Initials': 'KD', 'LastName': 'Aldape', 'Affiliation': 'Department of Neuropathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jesse G', 'Initials': 'JG', 'LastName': 'Dixon', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'S Keith', 'Initials': 'SK', 'LastName': 'Anderson', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jane H', 'Initials': 'JH', 'LastName': 'Cerhan', 'Affiliation': 'Departments of Psychiatry and Psychology, Houston, Texas, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Wefel', 'Affiliation': 'Departments of Neuro-Oncology and Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Klein', 'Affiliation': 'Department of Medical Psychology, VU University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Grossman', 'Affiliation': 'Department of Oncology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schiff', 'Affiliation': 'Department of Neurology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Raizer', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Dhermain', 'Affiliation': 'Department of Radiation Therapy, Gustave Roussy Cancer Institute, Villejuif, France.'}, {'ForeName': 'Donald G', 'Initials': 'DG', 'LastName': 'Nordstrom', 'Affiliation': 'Medical Oncology, France Abben Cancer Center, Spencer, Iowa, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Flynn', 'Affiliation': 'Medical Oncology, Minnesota Oncology, Northfield, Minnesota, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Vogelbaum', 'Affiliation': 'Department of Neurosurgery, Cleveland Clinic, Cleveland, Ohio, USA.'}]",Neuro-oncology,['10.1093/neuonc/noaa168']
164,32648835,Preoperative education improves the preparedness for extubation at emergence from general anaesthesia!,"BACKGROUND


Preoperative patient education is an essential responsibility of any healthcare provider, especially an anaesthetist, and is beneficial for perioperative outcome. A smooth emergence and extubation is a clinical skill that needs to be mastered by an anaesthetist. The aim of this study was to analyse whether a detailed preoperative patient education improves the quality of and preparedness for extubation at emergence from general anaesthesia.
METHODS


One hundred patients were randomly assigned to two groups. The study group received a detailed preoperative patient education and counselling about the mode of anaesthesia, extubation process and their expected response at extubation while the control group received the routine counselling. The Extubation Quality Scale at emergence and the recovery profile in the post anaesthesia care unit were assessed for both groups.
RESULTS


The primary outcome was a better quality of extubation in the patients who received a detailed preoperative patient education. The Extubation Quality Scale was found to be better for patients in the study group (p < 0.001). The endotracheal tube tolerance at a minimum alveolar concentration of ≤0.2 and response to verbal commands at extubation were better for the study group (p < 0.05) besides an earlier discharge from post anaesthesia care unit (p < 0.005).
CONCLUSION


Preoperative patient education improves the patients' preparedness for and quality of extubation and recovery from general anaesthesia.",2022,The Extubation Quality Scale was found to be better for patients in the study group (p < 0.001).,['One hundred patients'],"['detailed preoperative patient education and counselling about the mode of anaesthesia, extubation process and their expected response at extubation while the control group received the routine counselling']","['Extubation Quality Scale', 'quality of and preparedness for extubation', 'better quality of extubation', 'endotracheal tube tolerance']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",100.0,0.0505093,The Extubation Quality Scale was found to be better for patients in the study group (p < 0.001).,"[{'ForeName': 'Zaka', 'Initials': 'Z', 'LastName': 'Sameen', 'Affiliation': 'Department of Anaesthesiology, Pain and Critical Care, Sher-I-Kashmir Institute of Medical Sciences, Srinagar, India.'}, {'ForeName': 'Khan', 'Initials': 'K', 'LastName': 'Talib', 'Affiliation': 'Department of Anaesthesiology, Pain and Critical Care, Sher-I-Kashmir Institute of Medical Sciences, Srinagar, India.'}, {'ForeName': 'Shaqul Q', 'Initials': 'SQ', 'LastName': 'Wani', 'Affiliation': 'Department of Radiation Oncology, Sher-I-Kashmir Institute of Medical Sciences, Srinagar, India.'}, {'ForeName': 'Muntasir', 'Initials': 'M', 'LastName': 'Ashraf', 'Affiliation': 'Department of Orthopaedics, Asian Institute of Medical Sciences, Faridabad, India.'}, {'ForeName': 'Showkat H', 'Initials': 'SH', 'LastName': 'Nengroo', 'Affiliation': 'Department of Anaesthesiology, Pain and Critical Care, Sher-I-Kashmir Institute of Medical Sciences, Srinagar, India.'}]",Journal of perioperative practice,['10.1177/1750458920936213']
165,32653445,Insufficient Calorie Intake Worsens Post-Discharge Quality of Life and Increases Readmission Burden in Heart Failure.,"OBJECTIVES


The purpose of this study was to evaluate the relationship between calorie intake and post-discharge outcomes in hospitalized patients with heart failure (HF).
BACKGROUND


Malnutrition increases adverse outcomes in HF, and dietary sodium restriction may inadvertently worsen nutritional intake.
METHODS


In a dietary intervention trial, baseline nutritional intake in HF inpatients was estimated using the Block Food Frequency Questionnaire (FFQ), and the Nutritional Risk Index (NRI) was calculated. Insufficient calorie intake was defined as <90% of metabolic needs, and a 15-point micronutrient deficiency score was created. Adjusted linear, logistic, and negative binomial regression were used to evaluate associations between insufficient calorie intake and quality of life (using the Kansas City Cardiomyopathy Questionnaire Clinical Summary [KCCQ-CS]), readmission risk, and days rehospitalized over 12 weeks.
RESULTS


Among 57 participants (70 ± 8 years of age; 31% female; mean body mass index 32 ± 8 kg/m 2 ); median sodium and calorie intake amounts were 2,987 mg/day (interquartile range [IQR]: 2,160 to 3,540 mg/day) and 1,602 kcal/day (IQR: 1,201 to 2,142 kcal/day), respectively; 11% of these patients were screened as malnourished by the NRI. All patients consuming <2,000 mg/day sodium had insufficient calorie intake; this group also more frequently had dietary micronutrient and protein deficiencies. At 12 weeks, patients with insufficient calorie intake had less improvement in the KCCQ-CS score (β = -14.6; 95% confidence interval [CI]: -27.3 to -1.9), higher odds of readmission (odds ratio: 14.5; 95% CI: 2.2 to 94.4), and more days rehospitalized (incident rate ratio: 31.3; 95% CI: 4.3 to 229.3).
CONCLUSIONS


Despite a high prevalence for obesity and rare overt malnutrition, insufficient calorie intake was associated with poorer post-discharge quality of life and increased burden of readmission in patients with HF. Inpatient dietary assessment could improve readmission risk stratification and identify patients for nutritional intervention. (Geriatric Out of Hospital Randomized Meal Trial in Heart Failure [GOURMET-HF] NCT02148679).",2020,"At 12 weeks, patients with insufficient calorie intake had less improvement in the KCCQ-CS score (β = -14.6; 95% confidence interval [CI]: -27.3 to -1.9), higher odds of readmission (odds ratio [OR] 14.5; 95% CI: 2.2 to 94.4), and more days rehospitalized (incident rate ratio [IRR]: 31.3; 95% CI: 4.3 to 229.3).
","['Heart\xa0Failure', 'patients with HF', '57 participants (70 ± 8 years of age; 31% female; mean body mass index 32 ± 8\xa0kg/m 2 ); median sodium and calorie intake amounts were 2,987 (interquartile range [IQR]: 2,160 to 3,540) mg/day and 1,602', 'hospitalized patients with heart failure (HF']",[],"['burden of readmission', 'insufficient calorie intake and quality of life (using the Kansas City Cardiomyopathy Questionnaire Clinical Summary [KCCQ-CS]), readmission risk, and days rehospitalized', 'KCCQ-CS score', 'Insufficient calorie intake', 'Block Food Frequency Questionnaire (FFQ), and the Nutritional Risk Index (NRI', 'readmission risk stratification']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]",[],"[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0695731,"At 12 weeks, patients with insufficient calorie intake had less improvement in the KCCQ-CS score (β = -14.6; 95% confidence interval [CI]: -27.3 to -1.9), higher odds of readmission (odds ratio [OR] 14.5; 95% CI: 2.2 to 94.4), and more days rehospitalized (incident rate ratio [IRR]: 31.3; 95% CI: 4.3 to 229.3).
","[{'ForeName': 'Feriha', 'Initials': 'F', 'LastName': 'Bilgen', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Peiyu', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Armella', 'Initials': 'A', 'LastName': 'Poggi', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wells', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Trumble', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Helmke', 'Affiliation': 'Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Teruya', 'Affiliation': 'Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Tonimarie', 'Initials': 'T', 'LastName': 'Catalan', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Rosenblum', 'Affiliation': 'Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Cornellier', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Wahida', 'Initials': 'W', 'LastName': 'Karmally', 'Affiliation': 'Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Mathew S', 'Initials': 'MS', 'LastName': 'Maurer', 'Affiliation': 'Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Hummel', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan; Columbia University, New York, New York. Electronic address: scothumm@med.umich.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.04.004']
166,32669306,Effects of Intensive Blood Pressure Control in Patients with and without Albuminuria:  Post Hoc  Analyses from SPRINT.,"BACKGROUND AND OBJECTIVES


It is unclear whether the presence of albuminuria modifies the effects of intensive systolic BP control on risk of eGFR decline, cardiovascular events, or mortality.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


The Systolic Blood Pressure Intervention Trial randomized nondiabetic adults ≥50 years of age at high cardiovascular risk to a systolic BP target of <120 or <140 mm Hg, measured by automated office BP. We compared the absolute risk differences and hazard ratios of ≥40% eGFR decline, the Systolic Blood Pressure Intervention Trial primary cardiovascular composite outcome, and all-cause death in those with or without baseline albuminuria (urine albumin-creatinine ratio ≥30 mg/g).
RESULTS


Over a median follow-up of 3.1 years, 69 of 1723 (4%) participants with baseline albuminuria developed ≥40% eGFR decline compared with 61 of 7162 (1%) participants without albuminuria. Incidence rates of ≥40% eGFR decline were higher in participants with albuminuria (intensive, 1.74 per 100 person-years; standard, 1.17 per 100 person-years) than in participants without albuminuria (intensive, 0.48 per 100 person-years; standard, 0.11 per 100 person-years). Although effects of intensive BP lowering on ≥40% eGFR decline varied by albuminuria on the relative scale (hazard ratio, 1.48; 95% confidence interval, 0.91 to 2.39 for albumin-creatinine ratio ≥30 mg/g; hazard ratio, 4.55; 95% confidence interval, 2.37 to 8.75 for albumin-creatinine ratio <30 mg/g;  P  value for interaction <0.001), the absolute increase in ≥40% eGFR decline did not differ by baseline albuminuria (incidence difference, 0.38 events per 100 person-years for albumin-creatinine ratio ≥30 mg/g; incidence difference, 0.58 events per 100 person-years for albumin-creatinine ratio <30 mg/g;  P  value for interaction =0.60). Albuminuria did not significantly modify the beneficial effects of intensive systolic BP lowering on cardiovascular events or mortality evaluated on relative or absolute scales.
CONCLUSIONS


Albuminuria did not modify the absolute benefits and risks of intensive systolic BP lowering.",2020,"Albuminuria did not significantly modify the beneficial effects of intensive systolic BP lowering on cardiovascular events or mortality evaluated on relative or absolute scales.
","['nondiabetic adults ≥50 years of age at high cardiovascular risk to a systolic BP target of <120 or <140 mm Hg, measured by automated office BP', 'Patients with and without Albuminuria', 'participants with albuminuria (intensive, 1.74 per 100 person-years; standard, 1.17 per 100 person-years) than in participants without albuminuria (intensive, 0.48 per 100 person-years; standard, 0.11 per 100 person-years']",['Intensive Blood Pressure Control'],"['eGFR decline, cardiovascular events, or mortality', 'Incidence rates of ≥40% eGFR decline']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517494', 'cui_str': '1.17'}, {'cui': 'C4517461', 'cui_str': '0.48'}, {'cui': 'C4517425', 'cui_str': '0.11'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.459874,"Albuminuria did not significantly modify the beneficial effects of intensive systolic BP lowering on cardiovascular events or mortality evaluated on relative or absolute scales.
","[{'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Chang', 'Affiliation': 'Kidney Health Research Institute, Department of Population Health Sciences, Geisinger Health System, Danville, Pennsylvania achang@geisinger.edu.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Kramer', 'Affiliation': 'Division of Nephrology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Boucher', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Morgan E', 'Initials': 'ME', 'LastName': 'Grams', 'Affiliation': 'Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Berlowitz', 'Affiliation': 'Department of Public Health, University of Massachusetts-Lowell, Lowell, Massachusetts.'}, {'ForeName': 'Udayan', 'Initials': 'U', 'LastName': 'Bhatt', 'Affiliation': 'Division of Nephrology, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Cohen', 'Affiliation': 'Renal Division, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Drawz', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'Punzi Medical Center, Trinity Hypertension and Metabolic Research Institute, Carollton, Texas.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Amret', 'Initials': 'A', 'LastName': 'Hawfield', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Horwitz', 'Affiliation': 'Division of Nephrology, MetroHealth Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McLouth', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science, Wake Forest Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Morisky', 'Affiliation': 'Department of Community Health Sciences, University of California, Los Angeles Fielding School of Public Health, Los Angeles, California.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Papademetriou', 'Affiliation': 'Department of Cardiology, Veterans Affairs Medical Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Wall', 'Affiliation': 'Division of Nephrology, Veterans Affairs Medical Center, Memphis, Tennessee.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Zias', 'Affiliation': 'Stony Brook University School of Medicine, Stony Brook, New York.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.12371019']
167,33105455,Can Upstream Patient Education Improve Fracture Care in a Digital World? Use of a Decision Aid for the Treatment of Displaced Diaphyseal Clavicle Fractures.,"BACKGROUND


The increasing proportion of telemedicine and virtual care in orthopaedic surgery presents an opportunity for upstream delivery of patient facing tools, such as decision aids. Displaced diaphyseal clavicle fractures (DDCFs) are ideal for a targeted intervention because there is no superior treatment, and decisions are often dependent on patient's preference. A decision aid provided before consultation may educate a patient and minimize decisional conflict similarly to inperson consultation with an orthopaedic traumatologist.
METHODS


Patients with DDCF were enrolled into 2 groups. The usual care group participated in a discussion with a trauma fellowship-trained orthopaedic surgeon. Patients in the intervention group were administered a DDCF decision aid designed with the International Patient Decision Aid Standards. Primary comparisons were made based on a decisional conflict score. Secondary outcomes included treatment choice, pain score, QuickDASH, and opinion toward cosmetic appearance.
RESULTS


A total of 41 patients were enrolled. Decisional conflict scores were similar and low between the 2 groups: 11.8 (usual care) and 11.4 (decision aid). There were no differences in secondary outcomes between usual care and the decision aid.
DISCUSSION


Our decision aid for the management of DDCF produces a similarly low decisional conflict score to consultation with an orthopaedic trauma surgeon. This decision aid could be a useful resource for surgeons who infrequently treat this injury or whose practices are shifting toward telemedicine visits. Providing a decision aid before consultation may help incorporate patient's values and preferences into the decision-making process between surgery and nonoperative management.
LEVEL OF EVIDENCE


Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2021,Our decision aid for the management of DDCF produces a similarly low decisional conflict score to consultation with an orthopaedic trauma surgeon.,"['Patients with DDCF were enrolled into two groups', 'displaced diaphyseal clavicle fractures', '41 patients enrolled', 'Displaced diaphyseal clavicle fractures (DDCF']","['usual care group participated in a discussion with a trauma fellowship trained orthopaedic surgeon', 'DDCF decision aid designed with International Patient Decision Aid Standards']","['decisional conflict score', 'Decisional conflict scores', 'treatment choice, pain score, QuickDASH, and opinion toward cosmetic appearance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",41.0,0.0517422,Our decision aid for the management of DDCF produces a similarly low decisional conflict score to consultation with an orthopaedic trauma surgeon.,"[{'ForeName': 'Cara H', 'Initials': 'CH', 'LastName': 'Lai', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA; and.'}, {'ForeName': 'Malcolm R', 'Initials': 'MR', 'LastName': 'DeBaun', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': 'Van Rysselberghe', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Geoffrey D', 'Initials': 'GD', 'LastName': 'Abrams', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Kamal', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Julius A', 'Initials': 'JA', 'LastName': 'Bishop', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Gardner', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001916']
168,33085578,Evaluation of a Proactive Smoking Cessation Electronic Visit to Extend the Reach of Evidence-Based Cessation Treatment via Primary Care.,"Background:   Best practice guidelines for smoking cessation treatment through primary care advise the 5As model. However, compliance with these guidelines is poor, leaving many smokers untreated. The purpose of this study was to develop and preliminarily evaluate an asynchronous smoking cessation electronic visit (e-visit) that could be delivered proactively through the electronic health record (EHR) to adult smokers treated within primary care. The goal of the e-visit is to automate 5As delivery to ensure that all smokers receive evidence-based cessation treatment. As such, the aims of this study were twofold: (1) to examine acceptability, feasibility, and treatment metrics associated with e-visit utilization and (2) to preliminarily examine efficacy relative to treatment as usual (TAU) within primary care.   Methods:   Participants ( n  = 51) were recruited from primary care practices between November 2018 and October 2019 and randomized 2:1 to receive either the smoking cessation e-visit or TAU. Participants completed assessments of cessation outcomes 1-month and 3-months postenrollment and e-visit analytics data were gathered from the EHR.   Results:   Self-report feedback from e-visit participants indicated satisfaction with the intervention and interest in using e-visits again in the future. Nearly all e-visits resulted in prescription of a U.S. Food and Drug Administration (FDA)-approved smoking cessation medication. In general, smoking cessation outcomes favored the e-visit condition at both 1 (odds ratios [ORs]: 2.10-5.39) and 3 months (ORs: 1.31-4.67).   Conclusions:   These results preliminarily indicate the feasibility, acceptability, and efficacy of this smoking cessation e-visit within primary care. Future studies should focus on larger scale examination of effectiveness and implementation across settings. The clinicaltrials.gov registration number for this trial is NCT04316260.",2021,Self-report feedback from e-visit participants indicated satisfaction with the intervention and interest in using e-visits again in the future.,"['Participants ( n \u2009=\u200951) were recruited from primary care practices between November 2018 and October 2019', 'adult smokers treated within primary care']","['asynchronous smoking cessation electronic visit (e-visit', 'smoking cessation e-visit or TAU']","['feasibility, acceptability, and efficacy']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0402341,Self-report feedback from e-visit participants indicated satisfaction with the intervention and interest in using e-visits again in the future.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dahne', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Marty', 'Initials': 'M', 'LastName': 'Player', 'Affiliation': 'Department of Family Medicine,Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Dee W', 'Initials': 'DW', 'LastName': 'Ford', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'Diaz', 'Affiliation': 'Department of Family Medicine,Medical University of South Carolina, Charleston, South Carolina, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0167']
169,33095038,Ivacaftor in People with Cystic Fibrosis and a  3849+10kb C → T  or  D1152H  Residual Function Mutation.,"Rationale:  Ivacaftor's clinical effects in the residual function mutations  3849 + 10kb C→T  and  D1152H  warrant further characterization. Objectives:  To evaluate ivacaftor's effect in people with cystic fibrosis aged ≥6 years with  3849 + 10kb C→T  or  D1152H  residual function mutations and to explore the correlation between ivacaftor-induced organoid-based cystic fibrosis transmembrane conductance regulator function measurements and clinical response to ivacaftor. Methods:  Participants were randomized (1:1) in this placebo-controlled crossover study; each treatment sequence included two 8-week treatments with an 8-week washout period. The primary endpoint was absolute change in lung clearance index 2.5  from baseline through Week 8. Additional endpoints included lung function, patient-reported outcomes, and  in vitro  intestinal organoid-based measurements of ivacaftor-induced cystic fibrosis transmembrane conductance regulator function. Results:  Of 38 participants, 37 completed the study. The primary endpoint was met; the Bayesian posterior probability of improvement in lung clearance index 2.5  with ivacaftor versus placebo was >99%. Additional endpoints improved with ivacaftor. Safety findings were consistent with ivacaftor's known safety profile. Dose-dependent swelling was observed in 23 of 25 viable organoid cultures with ivacaftor treatment. Correlations between ivacaftor-induced organoid swelling and clinical endpoints were negligible to low. Conclusions:  In people with cystic fibrosis aged ≥6 years with a  3849 + 10kb C→T  or  D1152H  mutation, ivacaftor treatment improved clinical endpoints compared with placebo; however, there was no correlation between organoid swelling and change in clinical endpoints. The organoid assay may assist in identification of ivacaftor-responsive mutations but in this study did not predict magnitude of clinical benefit for individual people with cystic fibrosis with these two mutations.Clinical trial registered with ClinicalTrials.gov (NCT03068312).",2021,The primary endpoint was met; the Bayesian posterior probability of improvement in lung clearance index2.5 with ivacaftor vs placebo was >99%.,"['people with cystic fibrosis aged ≥6 years with a 3849+10kb C →T or D1152H mutation', 'People With Cystic Fibrosis and a 3849+10kb C →T or D1152H Residual Function Mutation', 'people with cystic fibrosis aged ≥6 years with 3849+10kb C→T or D1152H residual function mutations', '38 participants, 37 completed the study']","['ivacaftor', 'placebo', 'ivacaftor vs placebo', 'Ivacaftor']","['absolute change in lung clearance index2.5', 'lung function, patient-reported outcomes, and in vitro intestinal organoid-based measurements of ivacaftor-induced cystic fibrosis transmembrane conductance regulator function', 'Bayesian posterior probability of improvement in lung clearance index2.5']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0855766', 'cui_str': 'Residual function'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0029250', 'cui_str': 'Organoids'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.107007,The primary endpoint was met; the Bayesian posterior probability of improvement in lung clearance index2.5 with ivacaftor vs placebo was >99%.,"[{'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Kerem', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'Malena', 'Initials': 'M', 'LastName': 'Cohen-Cymberknoh', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'Reuven', 'Initials': 'R', 'LastName': 'Tsabari', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wilschanski', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Reiter', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shoseyov', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Gileles-Hillel', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Pugatsch', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Davies', 'Affiliation': 'European Cystic Fibrosis Society Lung Clearance Index Core Over Reading Centre, London, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Short', 'Affiliation': 'European Cystic Fibrosis Society Lung Clearance Index Core Over Reading Centre, London, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'European Cystic Fibrosis Society Lung Clearance Index Core Over Reading Centre, London, United Kingdom.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'DeSouza', 'Affiliation': 'Vertex Pharmaceuticals Inc., Boston, Massachusetts.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Sullivan', 'Affiliation': 'Vertex Pharmaceuticals Inc., Boston, Massachusetts.'}, {'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Doyle', 'Affiliation': 'Vertex Pharmaceuticals Inc., Boston, Massachusetts.'}, {'ForeName': 'Keval', 'Initials': 'K', 'LastName': 'Chandarana', 'Affiliation': 'Vertex Pharmaceuticals Inc., Boston, Massachusetts.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kinnman', 'Affiliation': 'Vertex Pharmaceuticals (Europe) Ltd., London, United Kingdom.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202006-659OC']
170,33094652,Differential effects of mindfulness meditation conditions on repetitive negative thinking and subjective time perspective: a randomized active-controlled study.,"Objective Preliminary findings suggest that different kinds of meditation could work on diverse cognitive and psychological processes. The present study aimed at disentangling the effects of three mindfulness techniques on mental rumination and subjective time perspective.  Design:  75 young healthy participants were randomly assigned to one of four conditions: mindful breathing, body scan, observing-thoughts meditation and an active control condition. The meditation groups practiced mindfulness daily and attended weekly group meetings for 8 weeks, while the control group was involved in reading and discussing a book about mindfulness.  Main outcome measures:  Self-report measures of mindfulness skills, ruminative thinking, attitude towards time, anxiety, depression and personality traits.  Results:  In all meditation conditions, analysis of covariance showed a significant improvement in mindfulness skills compared to the control group. We found a specific effect of mindful breathing in reducing participants' tendency to brooding and in increasing their positive vision of the future, compared to all other conditions.  Conclusions:  As expected, we found some differential effects: breathing meditation helped practitioners to train more effectively their ability to disengage from maladaptive ruminative thoughts, which could be reflected in a more optimistic attitude toward the future. These results provide useful information to structure better mindfulness-based interventions.",2021,"We found a specific effect of mindful breathing in reducing participants' tendency to brooding and in increasing their positive vision of the future, compared to all other conditions.  ",['75 young healthy participants'],"['meditation groups practiced mindfulness daily and attended weekly group meetings for 8\u2009weeks, while the control group was involved in reading and discussing a book about mindfulness', 'mindful breathing, body scan, observing-thoughts meditation and an active control condition', 'mindfulness meditation conditions']","['mental rumination and subjective time perspective', 'repetitive negative thinking and subjective time perspective', 'Self-report measures of mindfulness skills, ruminative thinking, attitude towards time, anxiety, depression and personality traits', 'mindfulness skills']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0018262', 'cui_str': 'Group Practice'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0040226', 'cui_str': 'Time Perception'}, {'cui': 'C0424134', 'cui_str': 'Pessimistic'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0233849', 'cui_str': 'Character trait finding'}]",75.0,0.0180762,"We found a specific effect of mindful breathing in reducing participants' tendency to brooding and in increasing their positive vision of the future, compared to all other conditions.  ","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Feruglio', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, Udine, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Matiz', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, Udine, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Grecucci', 'Affiliation': 'Department of Psychology and Cognitive Science, University of Trento, Trento, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Pascut', 'Affiliation': 'Municipality of Udine, WHO Healthy Cities Project, Udine, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Fabbro', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, Udine, Italy.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Crescentini', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, Udine, Italy.'}]",Psychology & health,['10.1080/08870446.2020.1836178']
171,33107110,Adiposity is associated with anovulation independent of serum free testosterone: A prospective cohort study.,"BACKGROUND


Obesity, a body mass index (BMI) ≥30 kg/m 2  , is linked to infertility, potentially through a greater risk of anovulation due to elevated androgens. Yet, previous studies have not directly assessed the impact of adiposity, or body fat, on anovulation in the absence of clinical infertility.
OBJECTIVE


To characterise the associations between adiposity and anovulation among women menstruating on a regular basis.
METHODS


Women from the EAGeR trial (n = 1200), a randomised controlled trial of low-dose aspirin and pregnancy loss among women trying to conceive, were used to estimate associations between adiposity and incident anovulation. Participants completed baseline questionnaires and anthropometry, and provided blood specimens. Women used fertility monitors for up to six consecutive menstrual cycles, with collection of daily first morning voids for hormone analysis in the first two menstrual cycles for prospective assessment of anovulation. Anovulation was assessed by urine pregnanediol glucuronide or luteinising hormone concentration or the fertility monitor. Weighted mixed-effects log-binomial regression was used to estimate associations between measures of adiposity and incident anovulation, adjusted for free (bioavailable) testosterone, anti-Mullerian hormone (AMH), serum lipids, and demographic and life style factors.
RESULTS


343 (28.3%) women experienced at least one anovulatory cycle. Anovulation risk was higher per kg/m 2  greater BMI (relative risk [RR] 1.03, 95% confidence interval (CI) 1.01, 1.04), cm waist circumference (RR 1.01, 95% CI 1.00, 1.02), mm subscapular skinfold (RR 1.02, 95% CI 1.01, 1.03), and mm middle upper arm circumference (RR 1.04, 95% CI 1.01, 1.06) adjusted for serum free testosterone, AMH, lipids, and other factors.
CONCLUSIONS


Adiposity may be associated with anovulation through pathways other than testosterone among regularly menstruating women. This may account in part for reported associations between greater adiposity and infertility among women having menstrual cycles regularly. Understanding the association between adiposity and anovulation might lead to targeted interventions for preventing infertility.",2021,"Anovulation risk was higher per kg/m 2  greater BMI (relative risk [RR] 1.03, 95% confidence interval (CI) 1.01, 1.04), cm waist circumference (RR 1.01, 95% CI 1.00, 1.02), mm subscapular skinfold (RR 1.02, 95% CI 1.01, 1.03), and mm middle upper arm circumference (RR 1.04, 95% CI 1.01, 1.06) adjusted for serum free testosterone, AMH, lipids, and other factors.
","['343 (28.3%) women experienced at least one anovulatory cycle', 'Women from the EAGeR trial (n\xa0', 'regularly menstruating women', 'women menstruating on a regular basis']",['aspirin'],"['serum free testosterone, AMH, lipids, and other factors', 'cm waist circumference', 'Anovulation', 'adiposity and incident anovulation, adjusted for free (bioavailable) testosterone, anti-Mullerian hormone (AMH), serum lipids, and demographic and life style factors', 'adiposity and anovulation', 'Adiposity', 'Anovulation risk', 'mm subscapular skinfold']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0429468', 'cui_str': 'Anovulatory'}, {'cui': 'C0558083', 'cui_str': 'Enthusiastic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0066928', 'cui_str': 'Mullerian regression factor'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0003128', 'cui_str': 'Anovulation'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.186672,"Anovulation risk was higher per kg/m 2  greater BMI (relative risk [RR] 1.03, 95% confidence interval (CI) 1.01, 1.04), cm waist circumference (RR 1.01, 95% CI 1.00, 1.02), mm subscapular skinfold (RR 1.02, 95% CI 1.01, 1.03), and mm middle upper arm circumference (RR 1.04, 95% CI 1.01, 1.06) adjusted for serum free testosterone, AMH, lipids, and other factors.
","[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Bloom', 'Affiliation': 'Departments of Environmental Health Sciences and Epidemiology and Biostatistics, University at Albany, State University of New York, Rensselaer, NY, USA.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Aijun', 'Initials': 'A', 'LastName': 'Ye', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Keewan', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Kuhr', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Carrie J', 'Initials': 'CJ', 'LastName': 'Nobles', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Connell', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}]",Paediatric and perinatal epidemiology,['10.1111/ppe.12726']
172,33100049,Effects of Intensive Systolic Blood Pressure Control on All-Cause Hospitalizations.,"Intensive blood pressure control decreases the rate of cardiovascular events by >25% compared with standard blood pressure control. We sought to determine whether the decrease in cardiovascular events seen with intensive blood pressure control is associated with an increased rate of other causes of hospitalization. This is a post hoc analysis of SPRINT (Systolic Blood Pressure Intervention Trial) in 9361 adult participants with hypertension and elevated cardiovascular risk. Participants were randomly assigned to an intensive or standard systolic blood pressure goal (<120 or <140 mm Hg, respectively). The primary outcome was hospitalization rates per 100 person-years for hospitalizations not associated with SPRINT primary events. After excluding hospitalizations linked to SPRINT primary events, there were 4678 participants with a rate of 19.70 hospitalizations per 100 person-years, compared with 4683 participants with a rate of 19.65 ( P =0.37). Equivalence testing shows that these hospitalization rates were statistically equivalent at the  P =0.05 level. Of those with hospitalizations, >1 hospitalization was seen in 38.8% of intensive arm participants and 41.9% of standard arm participants ( P =0.08). The mean cumulative count of nonprimary event hospitalizations was comparable between the two arms. The most common causes of hospitalization were cardiovascular (23.6%) followed by injuries, including bone and joint therapeutic procedures (15.7%), infections (12.0%), and nervous systems disorders (10.7%). No categories of hospitalization were statistically more common in the intensive arm compared with the standard arm. Thus, the decrease in cardiovascular events seen with intensive blood pressure control is not associated with an increased rate of other causes of hospitalization. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT01206062.",2020,Intensive blood pressure control decreases the rate of cardiovascular events by >25% compared with standard blood pressure control.,"['9361 adult participants with hypertension and elevated cardiovascular risk', '4678 participants with a rate of 19.70 hospitalizations per 100 person-years, compared with 4683 participants with a rate of 19.65 ( P =0.37']","['intensive or standard systolic blood pressure goal', 'Intensive Systolic Blood Pressure Control']","['hospitalization rates', 'bone and joint therapeutic procedures', 'categories of hospitalization', 'nervous systems disorders', 'mean cumulative count of nonprimary event hospitalizations', 'cardiovascular events', 'hospitalization rates per 100 person-years for hospitalizations not associated with SPRINT primary events', 'rate of cardiovascular events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517454', 'cui_str': '0.37'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0948995', 'cui_str': 'Bone and joint therapeutic procedures'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",9361.0,0.192607,Intensive blood pressure control decreases the rate of cardiovascular events by >25% compared with standard blood pressure control.,"[{'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'From the Departments of Internal Medicine (M.V.R., B.I.F., A.T.H.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Comeau', 'Affiliation': 'Biostatistics and Data Science (M.E.C., M.C.M., C.D.L.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Marion', 'Affiliation': 'Biostatistics and Data Science (M.E.C., M.C.M., C.D.L.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'From the Departments of Internal Medicine (M.V.R., B.I.F., A.T.H.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Amret T', 'Initials': 'AT', 'LastName': 'Hawfield', 'Affiliation': 'From the Departments of Internal Medicine (M.V.R., B.I.F., A.T.H.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Carl D', 'Initials': 'CD', 'LastName': 'Langefeld', 'Affiliation': 'Biostatistics and Data Science (M.E.C., M.C.M., C.D.L.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15868']
173,33109935,Embedding a Linkage to Preexposure Prophylaxis Care Intervention in Social Network Strategy and Partner Notification Services: Results From a Pilot Randomized Controlled Trial.,"BACKGROUND


Increased preexposure prophylaxis (PrEP) uptake among black men who have sex with men and black transgender women (BMSM/TW) is needed to end the HIV epidemic. Embedding a brief intervention in network services that engage individuals in HIV transmission networks for HIV/ sexually transmitted infections testing may be an important strategy to accelerate PrEP uptake.
SETTING


Partner Services PrEP study is a pilot, randomized, control trial to improve linkage to PrEP care among BMSM/TW presenting for network services in Chicago, IL, from 2015 to 2017.
METHODS


BMSM/TW (N = 146) aged 18-40 years were recruited from network services (partners services and social network strategy services). Intervention participants developed an individualized linkage plan based on the information-motivation-behavioral skills model and received minibooster sessions. Control participants received treatment as usual. Sociodemographic, behavioral, and clinical factors were examined at baseline and 3- and 12-month postintervention. Intent-to-treat analyses examined linkage to PrEP care within 3-month postintervention (primary outcome). Secondary outcomes were PrEP initiation, time to linkage to PrEP care, and time to PrEP initiation.
RESULTS


Compared with control participants, a significantly greater proportion of the intervention participants were linked to PrEP care within 3 months (24% vs. 11%; P = 0.04) and initiated PrEP (24% vs. 11%; P = 0.05). Among those linked to PrEP care within the study period, intervention participants were linked significantly sooner than control participants [median (interquartile range) days, 26.5 (6.0-141.8) vs. 191.5 (21.5-297.0); P = 0.05].
CONCLUSION


Study results support the preliminary efficacy of Partner Services PrEP to improve linkage to PrEP care and PrEP initiation among BMSM/TW.",2021,"(PS-PrEP) study is a pilot randomized control trial to improve linkage to PrEP care among BMSM/TW presenting for network services in Chicago, IL from 2015 to 2017.
","['Social Network Strategy and Partner Notification Services', 'BMSM/TW presenting for network services in Chicago, IL from 2015 to 2017', 'Black men who have sex with men and Black transgender women (BMSM/TW', 'BMSM/TW (N=146) aged 18-40 were recruited from network services (partners services and social network strategy services', 'Partner Services PrEP']","['individualized linkage plan based on the Information-Motivation-Behavioral Skills model and received mini-booster sessions', 'Increased pre-exposure prophylaxis (PrEP) uptake', 'PS-PrEP', 'Embedding a Linkage to Pre-Exposure Prophylaxis (PrEP) Care Intervention']","['Socio-demographic, behavioral, and clinical factors', 'PrEP initiation, time to linkage to PrEP care, and time to PrEP initiation']","[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0079990', 'cui_str': 'Partner Notification'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0820963,"(PS-PrEP) study is a pilot randomized control trial to improve linkage to PrEP care among BMSM/TW presenting for network services in Chicago, IL from 2015 to 2017.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Teixeira da Silva', 'Affiliation': 'Department of Combined Internal Medicine and Pediatrics, University of Chicago, Chicago, IL.'}, {'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Bouris', 'Affiliation': 'School of Social Service Administration, University of Chicago, Chicago, IL.'}, {'ForeName': 'Arthi', 'Initials': 'A', 'LastName': 'Ramachandran', 'Affiliation': 'Chicago Center for HIV Elimination, Chicago, IL.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Blocker', 'Affiliation': 'Chicago Center for HIV Elimination, Chicago, IL.'}, {'ForeName': 'Billy', 'Initials': 'B', 'LastName': 'Davis', 'Affiliation': 'Chicago Center for HIV Elimination, Chicago, IL.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Harris', 'Affiliation': 'Chicago Center for HIV Elimination, Chicago, IL.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pyra', 'Affiliation': 'Chicago Center for HIV Elimination, Chicago, IL.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Rusie', 'Affiliation': 'Chicago Center for HIV Elimination, Chicago, IL.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Brewer', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Pagkas-Bather', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hotton', 'Affiliation': 'Chicago Center for HIV Elimination, Chicago, IL.'}, {'ForeName': 'Jessica P', 'Initials': 'JP', 'LastName': 'Ridgway', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'McNulty', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Bhatia', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL; and.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Schneider', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002548']
174,33094725,A randomized controlled trial of oxygen therapy for patients who do not respond to upper airway surgery for obstructive sleep apnea.,"STUDY OBJECTIVES


We aimed to determine whether patients diagnosed with obstructive sleep apnea (OSA) who fail to respond to upper airway surgery may be successfully treated with supplemental oxygen and whether we could identify baseline physiologic endotypes (ie, collapsibility, loop gain, arousal threshold, and muscle compensation) that predict response to oxygen therapy.
METHODS


We conducted a single night, randomized double-blinded cross over trial in which patients with OSA who failed to respond to upper airway surgery were treated on separate nights with oxygen therapy (4 L/min) or placebo (medical air). Effect of oxygen/air on OSA on key polysomnography outcomes were assessed: apnea-hypopnea index (AHI), AHI without desaturation (ie, flow-based AHI), arousal index, and morning blood pressure. OSA endotypes were estimated from the polysomnography signals to determine whether baseline OSA physiology could be used to predict response to oxygen therapy.
RESULTS


There was a statistically significant reduction in AHI and flow-based AHI on oxygen vs placebo (flow-based AHI: 42.4 ± 21.5 vs 30.5 ± 17.1 events/h, P = .008). Arousal index was also reduced on oxygen vs placebo (41.1 ± 19.5 vs 33.0 ± 15.3 events/h, P = .006). There was no significant difference in morning blood pressure between oxygen and placebo. Although 7 of 20 individuals experienced a 50% reduction or greater in flow-based AHI on oxygen (responders), there was no difference in the baseline OSA endotypes (or clinical characteristics) between responders and nonresponders.
CONCLUSIONS


Our findings demonstrate that a proportion of patients who fail to respond to upper airway surgery for OSA respond acutely to treatment with supplemental oxygen.
CLINICAL TRIAL REGISTRATION


Registry: Australian New Zealand Clinical Trials Registry; Name: Oxygen therapy for treating patients with residual obstructive sleep apnea following upper airway surgery; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373566; Identifier: ACTRN12617001361392.",2021,"There was a statistically significant reduction in AHI and AHI fb  on oxygen versus placebo (AHI fb:  42.4±21.5 vs. 30.5±17.1 events/h, p = 0.008).","['patients diagnosed with obstructive sleep apnea (OSA) who fail to respond to upper airway surgery', 'patients who do not respond to upper airway surgery for obstructive sleep apnea', 'OSA patients who failed to respond to upper airway surgery', 'patients with residual obstructive sleep apnoea following upper airway surgery']","['placebo', 'oxygen therapy', 'oxygen therapy (4 L/min) or placebo (medical air', 'oxygen/air on OSA']","['apnea-hypopnea index (AHI), AHI without desaturation (i.e. flow-based AHI [AHI fb ]), arousal index and morning blood pressure', 'baseline OSA endotypes', 'AHI and AHI fb  on oxygen', 'morning blood pressure', 'Arousal index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C3536832', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]",,0.349102,"There was a statistically significant reduction in AHI and AHI fb  on oxygen versus placebo (AHI fb:  42.4±21.5 vs. 30.5±17.1 events/h, p = 0.008).","[{'ForeName': 'Simon A', 'Initials': 'SA', 'LastName': 'Joosten', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Ai-Ming', 'Initials': 'AM', 'LastName': 'Wong', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Landry', 'Affiliation': 'Department of Physiology, School of Biomedical Sciences and Biomedical Discovery Institute, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Leong', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital & Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Beatty', 'Affiliation': 'Department of Physiology, School of Biomedical Sciences and Biomedical Discovery Institute, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Thomson', 'Affiliation': 'Department of Physiology, School of Biomedical Sciences and Biomedical Discovery Institute, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Stonehouse', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Turton', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Garun S', 'Initials': 'GS', 'LastName': 'Hamilton', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Edwards', 'Affiliation': 'Department of Physiology, School of Biomedical Sciences and Biomedical Discovery Institute, Monash University, Melbourne, Victoria, Australia.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8920']
175,33111239,Substance Use Disorder Detection Rates Among Providers of General Medical Inpatients.,"BACKGROUND


The prevalence of substance use disorders is higher among medical inpatients than in the general population, placing inpatient providers in a prime position to detect these patients and intervene.
OBJECTIVE


To assess provider detection rates of substance use disorders among medical inpatients and to identify patient characteristics associated with detection.
DESIGN


Data drawn from a cluster randomized controlled trial that tested the effectiveness of three distinct implementation strategies for providers to screen patients for substance use disorders and deliver a brief intervention (Clinical Trials.gov : NCT01825057).
PARTICIPANTS


A total of 1076 patients receiving care from 13 general medical inpatient units in a large teaching hospital participated in this study.
MAIN MEASURES


Data sources included patient self-reported questionnaires, a diagnostic interview for substance use disorders, and patient medical records. Provider detection was determined by diagnoses documented in medical records.
KEY RESULTS


Provider detection rates were highest for nicotine use disorder (72.2%) and lowest for cannabis use disorder (26.4%). Detection of alcohol use disorder was more likely among male compared to female patients (OR (95% CI) = 4.0 (1.9, 4.8)). When compared to White patients, alcohol (OR (95% CI) = 0.4 (0.2, 0.6)) and opioid (OR (95% CI) = 0.2 (0.1, 0.7)) use disorders were less likely to be detected among Black patients, while alcohol (OR (95% CI) = 0.3 (0.0, 2.0)) and cocaine (OR (95% CI) = 0.3 (0.1, 0.9)) use disorders were less likely to be detected among Hispanic patients. Providers were more likely to detect nicotine, alcohol, opioid, and other drug use disorders among patients with higher addiction severity (OR (95% CI) = 1.20 (1.08-1.34), 1.62 (1.48, 1.78), 1.46 (1.07, 1.98), 1.38 (1.00, 1.90), respectively).
CONCLUSIONS


Findings indicate patient characteristics, including gender, race, and addiction severity impact rates of provider detection. Instituting formal screening for all substances may increase provider detection and inform treatment decisions.",2021,"KEY RESULTS


Provider detection rates were highest for nicotine use disorder (72.2%) and lowest for cannabis use disorder (26.4%).","['Providers of General Medical Inpatients', 'A total of 1076 patients receiving care from 13 general medical inpatient units in a large teaching hospital participated in this study']",[],"['patient self-reported questionnaires, a diagnostic interview for substance use disorders, and patient medical records', 'Provider detection rates', 'Provider detection']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",1076.0,0.05571,"KEY RESULTS


Provider detection rates were highest for nicotine use disorder (72.2%) and lowest for cannabis use disorder (26.4%).","[{'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Serowik', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA. kristin.serowik@yale.edu.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Yonkers', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gilstad-Hayden', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Forray', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zimbrean', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, 300 George Street, Suite 301, New Haven, CT, 06520, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06319-7']
176,33098800,Effects of intensive versus standard blood pressure control on domain-specific cognitive function: a substudy of the SPRINT randomised controlled trial.,"BACKGROUND


Results from the Systolic Blood Pressure Intervention Trial (SPRINT) showed that intensive control of systolic blood pressure significantly reduced the occurrence of mild cognitive impairment, but not probable dementia. We investigated the effects of intensive lowering of systolic blood pressure on specific cognitive functions in a preplanned substudy of participants from SPRINT.
METHODS


SPRINT was an open-label, multicentre, randomised controlled trial undertaken at 102 sites, including academic medical centres, Veterans Affairs medical centres, hospitals, and independent clinics, in the USA and Puerto Rico. Participants were adults aged 50 years or older with systolic blood pressure higher than 130 mm Hg, but without diabetes, history of stroke, or dementia. Participants were randomly assigned (1:1) to a systolic blood pressure goal of less than 120 mm Hg (intensive treatment) versus less than 140 mm Hg (standard treatment). All major classes of antihypertensive agents were included. A subgroup of randomly assigned participants including, but not limited to, participants enrolled in an MRI substudy was then selected for a concurrent substudy of cognitive function (target 2800 participants). Each individual was assessed with a screening cognitive test battery and an extended cognitive test battery at baseline and biennially during the planned 4-year follow-up. The primary outcomes for this substudy were standardised composite scores for memory (Logical Memory I and II, Modified Rey-Osterrieth Complex Figure [immediate recall], and Hopkins Verbal Learning Test-Revised [delayed recall]) and processing speed (Trail Making Test and Digit Symbol Coding). SPRINT was registered with ClinicalTrials.gov, NCT01206062.
FINDINGS


From Nov 23, 2010, to Dec 28, 2012, 2921 participants (mean age 68·4 years [SD 8·6], 1080 [37%] women) who had been randomly assigned in SPRINT were enrolled in the substudy (1448 received intensive treatment and 1473 received standard treatment). SPRINT was terminated early due to benefit observed in the primary outcome (composite of cardiovascular events). After a median follow-up of 4·1 years (IQR 3·7-5·8), there was no between-group difference in memory, with an annual decline in mean standardised domain score of -0·005 (95% CI -0·010 to 0·001) in the intensive treatment group and -0·001 (-0·006 to 0·005) in the standard treatment group (between-group difference -0·004, 95% CI -0·012 to 0·004; p=0·33). Mean standardised processing speed domain scores declined more in the intensive treatment group (between-group difference -0·010, 95% CI -0·017 to -0·002; p=0·02), with an annual decline of -0·025 (-0·030 to -0·019) for the intensive treatment group and -0·015 (-0·021 to 0·009) for the standard treatment group.
INTERPRETATION


Intensive treatment to lower systolic blood pressure did not result in a clinically relevant difference compared with standard treatment in memory or processing speed in a subgroup of participants from SPRINT. The effect of blood pressure lowering might not be evident in specific domains of cognitive function, but instead distributed across multiple domains.
FUNDING


National Heart, Lung, and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Aging, National Institute of Neurological Disorders and Stroke, and the Alzheimer's Association.",2020,"Mean standardised processing speed domain scores declined more in the intensive treatment group (between-group difference -0·010, 95% CI -0·017 to -0·002; p=0·02), with an annual decline of -0·025 (-0·030 to -0·019) for the intensive treatment group and -0·015","['2921 participants (mean age 68·4 years [SD 8·6], 1080 [37%] women) who had been randomly assigned in SPRINT were enrolled in the substudy (1448 received intensive treatment and 1473 received standard treatment', 'Participants were adults aged 50 years or older with systolic blood pressure higher than 130 mm Hg, but without diabetes, history of stroke, or dementia', 'participants from SPRINT', '102 sites, including academic medical centres, Veterans Affairs medical centres, hospitals, and independent clinics, in the USA and Puerto Rico', 'participants enrolled in an MRI substudy was then selected for a concurrent substudy of cognitive function (target 2800 participants']","['systolic blood pressure goal of less than 120 mm Hg (intensive treatment', 'intensive lowering of systolic blood pressure', 'intensive versus standard blood pressure control']","['standardised composite scores for memory (Logical Memory I and II, Modified Rey-Osterrieth Complex Figure [immediate recall], and Hopkins Verbal Learning Test-Revised [delayed recall]) and processing speed (Trail Making Test and Digit Symbol Coding', 'Mean standardised processing speed domain scores', 'domain-specific cognitive function', 'systolic blood pressure']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5192768', 'cui_str': '1080'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4517680', 'cui_str': '2800'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4505408', 'cui_str': 'Rey-Osterrieth Complex Figure'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",2921.0,0.271982,"Mean standardised processing speed domain scores declined more in the intensive treatment group (between-group difference -0·010, 95% CI -0·017 to -0·002; p=0·02), with an annual decline of -0·025 (-0·030 to -0·019) for the intensive treatment group and -0·015","[{'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: srapp@wakehealth.edu.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Bonnie C', 'Initials': 'BC', 'LastName': 'Sachs', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Chelune', 'Affiliation': 'Department of Neurology, University of Utah, School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Supiano', 'Affiliation': 'Department of Internal Medicine, University of Utah, School of Medicine, Salt Lake City, UT, USA; Veterans Affairs Salt Lake City Health Care System, Salt Lake City, UT, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Lerner', 'Affiliation': 'Department of Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Virginia G', 'Initials': 'VG', 'LastName': 'Wadley', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Valarie M', 'Initials': 'VM', 'LastName': 'Wilson', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Fine', 'Affiliation': 'Clinical Applications and Prevention Branch, National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Whittle', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA; Clement J Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Auchus', 'Affiliation': 'Department of Neurology, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Department of Internal Medicine, University of Utah, School of Medicine, Salt Lake City, UT, USA; Veterans Affairs Salt Lake City Health Care System, Salt Lake City, UT, USA.'}, {'ForeName': 'Dan R', 'Initials': 'DR', 'LastName': 'Berlowitz', 'Affiliation': 'Bedford Veterans Affairs Medical Center, Bedford, MA, USA; Department of Public Health, University of Massachusetts Lowell, Lowell, MA, USA.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Bress', 'Affiliation': 'Department of Population Health Sciences, University of Utah, School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Krousel-Wood', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA; Department of Medicine, Tulane University, New Orleans, LA, USA; Department of Epidemiology, Tulane University, New Orleans, LA, USA; Ochsner Health System, New Orleans, LA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Martindale-Adams', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Eliza C', 'Initials': 'EC', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Dena E', 'Initials': 'DE', 'LastName': 'Rifkin', 'Affiliation': 'Division of Nephrology-Hypertension, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Joni K', 'Initials': 'JK', 'LastName': 'Snyder', 'Affiliation': 'Clinical Applications and Prevention Branch, National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Tamariz', 'Affiliation': 'Miami Veterans Affairs Healthcare System, Miami, FL, USA; Division of Population Health and Computational Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Wolfgram', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA; Clement J Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Maryjo L', 'Initials': 'ML', 'LastName': 'Cleveland', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Linda O', 'Initials': 'LO', 'LastName': 'Nichols', 'Affiliation': 'Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, TN, USA.'}, {'ForeName': 'Robert Nick', 'Initials': 'RN', 'LastName': 'Bryan', 'Affiliation': 'Department of Diagnostic Medicine, Dell Medical School, University of Texas, Austin, TX, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Reboussin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30319-7']
177,33109394,Cue-based treatment for light smokers: A proof of concept pilot.,"INTRODUCTION


Light smoking (smoking ≤ 10 cigarettes per day or on some days) has become increasingly prevalent in the US and increases morbidity and mortality. Many light smokers do not experience significant nicotine withdrawal but instead smoke in response to cues. Minimal evidence exists supporting interventions to help light smokers quit smoking.
METHODS


We present results from a proof-of-concept pilot study designed to evaluate the feasibility and acceptability of a cue-based smoking cessation intervention targeted to light daily and intermittent smokers. Participants were randomized to one of two arms: Arm 1) standard smoking cessation treatment or Arm 2) standard smoking cessation treatment + enhanced cue-based treatment that included interactive texting to extend cue exposure treatment to real-world settings and cue management counseling.Outcomes included feasibility (number of participants who were recruited and who completed the intervention), acceptability (intervention ratings), and preliminary efficacy (7-day point prevalence abstinence).
RESULTS


We randomized 24 English and Spanish-speaking light smokers, 13 to the treatment arm and 11 to the control arm. Across both arms, 77% attended all counseling sessions, 90% rated these sessions as very useful and 100% said that they would recommend the intervention to a friend. 15% in the treatment arm had biochemically-validated smoking abstinence compared to 0% in the standard counseling arm.
CONCLUSIONS


Results from this proof-of-concept study demonstrated that a cue-based intervention is feasible and acceptable among light smokers and suggests the need for a fully powered study to assess this approach.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT03416621.",2021,"15% in the treatment arm had biochemically-validated smoking abstinence compared to 0% in the standard counseling arm.
",['light smokers'],"['Cue-based treatment', 'cue-based smoking cessation intervention', 'standard smoking cessation treatment or Arm 2) standard smoking cessation treatment\xa0+\xa0enhanced cue-based treatment that included interactive texting to extend cue exposure treatment to real-world settings and cue management counseling']","['morbidity and mortality', 'biochemically-validated smoking abstinence']","[{'cui': 'C3494624', 'cui_str': 'Light tobacco smoker'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",24.0,0.0327941,"15% in the treatment arm had biochemically-validated smoking abstinence compared to 0% in the standard counseling arm.
","[{'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC 27710, United States. Electronic address: kathryn.pollak@duke.edu.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Oliver', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States; Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, United States.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Pieper', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States; Department of Medicine, Duke University School of Medicine, Durham, NC 27710, United States.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States; Department of Medicine, Duke University School of Medicine, Durham, NC 27710, United States.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Noonan', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States; School of Nursing, Duke University, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Kennedy', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States.'}, {'ForeName': 'Isa', 'Initials': 'I', 'LastName': 'Granados', 'Affiliation': 'Department of Population Health Sciences, Duke University School of Medicine, Durham, NC 27710, United States.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Fish', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC 27710, United States; Department of Family Medicine and Community Health, Duke University School of Medicine, Durham, NC 27710, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106717']
178,33118927,"Effect of depression, anxiety, and stress symptoms on response to cognitive behavioral therapy for insomnia in patients with comorbid insomnia and sleep apnea: a randomized controlled trial.","STUDY OBJECTIVES


Patients with comorbid insomnia and sleep apnea (COMISA) report increased severity of depression, anxiety, and stress symptoms compared to patients with either insomnia or sleep apnea alone. Although cognitive behavioral therapy for insomnia (CBTi) is an effective treatment for COMISA, previous research suggests a reduced response to CBTi by patients with insomnia and depression, anxiety, and stress symptoms. Therefore, we used randomized controlled trial data to investigate the impact of depression, anxiety, and stress symptoms before treatment on changes in insomnia after CBTi vs control in patients with COMISA.
METHODS


145 patients with COMISA (insomnia as defined by the International Classification of Sleep Disorders, third edition and apnea-hypopnea index ≥ 15 events/h) were randomized to CBTi (n = 72) or no-treatment control (n = 73). One-week sleep diaries and standardized questionnaire measures of insomnia, sleepiness, fatigue, depression, anxiety, and stress were completed pretreatment and posttreatment. Mixed models were used to examine interactions between depression, anxiety, and stress symptoms before treatment, intervention-group (CBTi, control), and time (pretreatment, posttreatment) on insomnia symptoms.
RESULTS


Approximately half of this COMISA sample reported at least mild symptoms of depression (57%), anxiety (53%), and stress (48%) before treatment. Patients reporting greater depression, anxiety, and stress symptoms before treatment also reported increased severity of insomnia, daytime fatigue, and sleepiness. Improvements in questionnaire and diary-measured insomnia symptoms improved during CBTi and were not moderated by severity of depression, anxiety, or stress symptoms before treatment (all interaction P ≥ .11).
CONCLUSIONS


We found no evidence that symptoms of depression, anxiety, or stress impair the effectiveness of CBTi in improving insomnia symptoms in patients with COMISA. Patients with COMISA and comorbid symptoms of depression, anxiety, and stress should be referred for CBTi to treat insomnia and improve subsequent management of their obstructive sleep apnea.
CLINICAL TRIAL REGISTRATION


Registry: Australian New Zealand Clinical Trials Registry; Name: Treating comorbid insomnia with obstructive sleep apnea (COMISA) study: A new treatment strategy for patients with combined insomnia and sleep apnea; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365184; Identifier: ACTRN12613001178730.",2021,"Improvements in questionnaire and diary-measured insomnia symptoms improved during CBTi, and were not moderated by severity of depression, anxiety, or stress symptoms before treatment (all interaction p ≥ 0.11).
","['patients with COMISA', 'patients with either insomnia or sleep apnea alone', 'patients with combined insomnia and sleep apnoea, identifier', 'patients with comorbid insomnia and sleep apnea', 'comorbid insomnia with obstructive sleep apnoea', '145 patients with COMISA (ICSD-3 insomnia, apnea-hypopnea index ≥ 15 events/h', 'Patients with comorbid insomnia and sleep apnea (COMISA', 'Patients with COMISA and comorbid symptoms of depression, anxiety and stress']","['CBTi', 'cognitive behavioral therapy']","['sleep diaries and standardized questionnaire measures of insomnia, sleepiness, fatigue, depression, anxiety, and stress', 'severity of depression, anxiety, or stress symptoms', 'questionnaire and diary-measured insomnia symptoms', 'mild symptoms of depression', 'insomnia symptoms', 'severity of insomnia, daytime fatigue, and sleepiness', 'anxiety', 'depression, anxiety, and stress symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0436343', 'cui_str': 'Symptom mild'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}]",145.0,0.0286607,"Improvements in questionnaire and diary-measured insomnia symptoms improved during CBTi, and were not moderated by severity of depression, anxiety, or stress symptoms before treatment (all interaction p ≥ 0.11).
","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sweetman', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Lack', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Catcheside', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Antic', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Ching Li', 'Initials': 'CL', 'LastName': 'Chai-Coetzer', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Douglas', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Queensland, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': ""O'Grady"", 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dunn', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Queensland, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Queensland, Australia.'}, {'ForeName': 'Denzil', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Institute for Social Science Research (ISSR), The University of Queensland, Queensland, Australia.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8944']
179,33136226,Impact of the catechol-O-methyltransferase Val158Met polymorphism on the pharmacokinetics of L-dopa and its metabolite 3-O-methyldopa in combination with entacapone.,"In the pharmacotherapy of patients with Parkinson's disease (PD), entacapone reduces the peripheral metabolism of L-dopa to 3-O-methyldopa (3-OMD), thereby prolonging the half-life (t 1/2 ) of L-dopa and increasing the area under the concentration curve (AUC). The effect of entacapone on the pharmacokinetics of L-dopa differs between patients with high-activity (H/H) and low-activity (L/L) catechol-O-methyltransferase (COMT) Val158Met polymorphisms, but the effects are unclear in heterozygous (H/L) patients. 3-OMD has a detrimental effect and results in a poor response to L-dopa treatment in patients with PD; however, the influence of this polymorphism on the production of 3-OMD remains unknown. Therefore, the present study aimed to clarify the effect of the COMT Val158Met polymorphism on the concentrations of L-dopa and 3-OMD in the presence of entacapone. We performed an open-label, single-period, single-sequence crossover study at two sites in Japan. The study included 54 Japanese patients with PD, who underwent an acute L-dopa administration test with and without 100 mg entacapone on two different days. Entacapone increased L-dopa AUC 0-infinity  by 1.59 ± 0.26-fold in the H/H group, which was significantly higher than that in the H/L (1.41 ± 0.36-fold) and L/L (1.28 ± 0.21-fold) groups (p < 0.05). The concurrent administration of L-dopa with entacapone suppressed the increase in 3-OMD levels compared with L-dopa alone in all genotypes. Our results suggest that the COMT Val158Met polymorphism may be an informative biomarker for individualized dose adjustment of COMT inhibitors in the treatment of PD.",2021,"Entacapone increased L-dopa AUC 0-infinity  by 1.59 ± 0.26-fold in the H/H group, which was significantly higher than that in the H/L (1.41 ± 0.36-fold) and L/L (1.28 ± 0.21-fold) groups (p < 0.05).","['patients with PD', '54 Japanese patients with PD, who underwent an acute L-dopa administration test with and without 100\xa0mg entacapone on two different days', 'patients with high-activity (H/H) and low-activity (L/L) catechol-O-methyltransferase (COMT) Val158Met polymorphisms', ""patients with Parkinson's disease (PD""]","['catechol-O-methyltransferase Val158Met polymorphism', '3-OMD', 'Entacapone', 'entacapone']","['concentrations of L-dopa and 3-OMD', 'peripheral metabolism of L-dopa to 3-O-methyldopa (3-OMD', '3-OMD levels', 'L-dopa AUC 0-infinity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0165921', 'cui_str': 'entacapone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0047557', 'cui_str': '3-O-methyldopa'}, {'cui': 'C0165921', 'cui_str': 'entacapone'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0047557', 'cui_str': '3-O-methyldopa'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",54.0,0.0216638,"Entacapone increased L-dopa AUC 0-infinity  by 1.59 ± 0.26-fold in the H/H group, which was significantly higher than that in the H/L (1.41 ± 0.36-fold) and L/L (1.28 ± 0.21-fold) groups (p < 0.05).","[{'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Hospital Pharmacy and Pharmacology, Asahikawa Medical University, Asahikawa, 078-8510, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Omura', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Kasamo', 'Affiliation': 'Institutional Research Office, Asahikawa Medical University, Asahikawa, 078-8510, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Kawata', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Yonezawa', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Taruno', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Kyoto University, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Hisako', 'Initials': 'H', 'LastName': 'Endo', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, Asahikawa Medical University, Asahikawa, 078-8510, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Aizawa', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, Asahikawa Medical University, Asahikawa, 078-8510, Japan.'}, {'ForeName': 'Nobukatsu', 'Initials': 'N', 'LastName': 'Sawamoto', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Kyoto University, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Matsubara', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Takahashi', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Kyoto University, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Tasaki', 'Affiliation': 'Department of Hospital Pharmacy and Pharmacology, Asahikawa Medical University, Asahikawa, 078-8510, Japan. tasakiy@asahikawa-med.ac.jp.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-020-02267-y']
180,33120302,Ketamine vs. haloperidol for prevention of cognitive dysfunction and postoperative delirium: A phase IV multicentre randomised placebo-controlled double-blind clinical trial.,"STUDY OBJECTIVE


Delirium is frequently observed in the postoperative and intensive care unit (ICU) population. Due to the multifactorial origin of delirium and according to international guidelines (e.g., American Geriatrics Society; Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption (PADIS) guideline), there are several but no incontestable options for prevention and symptomatic treatment. The purpose of the Baden PRIDe (Prevention and Reduction of Incidence of postoperative Delirium) trial was to determine whether postoperative cognitive dysfunction and delirium could be prevented by the combination of possible preventive agents such as haloperidol and ketamine. In addition, pre- and postoperative levels of the biomarkers cortisol, neuron specific enolase (NSE) and S100β were measured to investigate their dynamics in delirious and non-delirious patients after surgery.
DESIGN


The Baden PRIDe Trial was an investigator-initiated, phase IV, two-centre, randomised, placebo-controlled, double-blind clinical trial.
SETTING


Perioperative care.
PATIENTS


182 adult patients that underwent elective or emergency surgery under general or combined (i.e., general and regional) anaesthesia.
INTERVENTIONS


Pre-anaesthetic, pharmacologic prevention of postoperative brain dysfunction with haloperidol, ketamine, and the combination of both vs. placebo.
MEASUREMENTS


Assessment of cognitive performance pre- and postoperatively with the MMSE, the DOS, the Nursing Delirium Screening Scale (Nu-DESC) or the Intensive Care Delirium Screening Checklist (ICDSC) during ICU stay.
MAIN RESULTS


None of the three study arms - haloperidol, ketamine, or both drugs combined - was significantly superior to placebo for prevention of postoperative brain dysfunction and delirium (P = 0.39). Measured levels of postoperative cortisol were significantly higher in delirious patients. S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.
CONCLUSIONS


The study results offer no possibility for a novel recommendation for prevention of postoperative cognitive decline including delirium. Perioperative S-100β trajectories in patients with cognitive deterioration suggest affection of glial cells in particular.
TRIAL REGISTRATION


ClinicalTrials.govNCT02433041; registered on April 7, 2015.",2021,"S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.
","['patients with cognitive deterioration suggest affection of glial cells in particular', '182 adult patients that underwent elective or emergency surgery under general or combined (i.e., general and regional) anaesthesia']","['haloperidol, ketamine', 'Ketamine vs. haloperidol', 'haloperidol and ketamine', 'placebo', 'haloperidol, ketamine, and the combination of both vs. placebo']","['pre- and postoperative levels of the biomarkers cortisol, neuron specific enolase (NSE) and S100β', 'cognitive dysfunction and postoperative delirium', 'postoperative NSE levels', 'cognitive performance pre- and postoperatively with the MMSE, the DOS, the Nursing Delirium Screening Scale (Nu-DESC) or the Intensive Care Delirium Screening Checklist (ICDSC) during ICU stay', 'Measured levels of postoperative cortisol', 'S-100β levels', 'postoperative brain dysfunction and delirium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0854193', 'cui_str': 'Cognitive deterioration'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",182.0,0.394449,"S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.
","[{'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Hollinger', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland; Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland. Electronic address: Alexa.Hollinger@usb.ch.'}, {'ForeName': 'Christoph A', 'Initials': 'CA', 'LastName': 'Rüst', 'Affiliation': 'Institute of Primary Care, University of Zurich, Pestalozzistrasse 24, 8091 Zurich, Switzerland. Electronic address: christoph.ruest@bluewin.ch.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Riegger', 'Affiliation': 'Department for Anesthesia, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: HarrietYvonne.Riegger@usb.ch.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Gysi', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: bianca.gysi@stud.unibas.ch.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Tran', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: fabian.tran@stud.unibas.ch.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Brügger', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: jonas.bruegger@stud.unibas.ch.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Huber', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: jan.huber@vtxmail.ch.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Toft', 'Affiliation': 'Department for Anaesthesia, Intensive Care and Emergency Medicine, See-Spital, Horgen and Kilchberg Branches, Asylstrasse 19, 8810 Horgen, Switzerland. Electronic address: Katharina.Toft@gmail.com.'}, {'ForeName': 'Madlen', 'Initials': 'M', 'LastName': 'Surbeck', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: madlen.surbeck@stud.unibas.ch.'}, {'ForeName': 'Hans-Ruedi', 'Initials': 'HR', 'LastName': 'Schmid', 'Affiliation': 'Central Laboratory, Cantonal Hospital Baden, Im Ergel 1, 5404 Baden, Switzerland. Electronic address: Hans-Ruedi.Schmid@ksb.ch.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Rentsch', 'Affiliation': 'Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland; Department of Clinical Chemistry and Laboratory Medicine, Petersgraben 4, 4031 Basel, Switzerland. Electronic address: Katharina.Rentsch@usb.ch.'}, {'ForeName': 'Luzius', 'Initials': 'L', 'LastName': 'Steiner', 'Affiliation': 'Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland; Department for Anesthesia, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: Luzius.Steiner@usb.ch.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siegemund', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland; Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland. Electronic address: Martin.Siegemund@usb.ch.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110099']
181,33113295,SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19.,"BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (Covid-19), which is most frequently mild yet can be severe and life-threatening. Virus-neutralizing monoclonal antibodies are predicted to reduce viral load, ameliorate symptoms, and prevent hospitalization.
METHODS


In this ongoing phase 2 trial involving outpatients with recently diagnosed mild or moderate Covid-19, we randomly assigned 452 patients to receive a single intravenous infusion of neutralizing antibody LY-CoV555 in one of three doses (700 mg, 2800 mg, or 7000 mg) or placebo and evaluated the quantitative virologic end points and clinical outcomes. The primary outcome was the change from baseline in the viral load at day 11. The results of a preplanned interim analysis as of September 5, 2020, are reported here.
RESULTS


At the time of the interim analysis, the observed mean decrease from baseline in the log viral load for the entire population was -3.81, for an elimination of more than 99.97% of viral RNA. For patients who received the 2800-mg dose of LY-CoV555, the difference from placebo in the decrease from baseline was -0.53 (95% confidence interval [CI], -0.98 to -0.08; P = 0.02), for a viral load that was lower by a factor of 3.4. Smaller differences from placebo in the change from baseline were observed among the patients who received the 700-mg dose (-0.20; 95% CI, -0.66 to 0.25; P = 0.38) or the 7000-mg dose (0.09; 95% CI, -0.37 to 0.55; P = 0.70). On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo. The percentage of patients who had a Covid-19-related hospitalization or visit to an emergency department was 1.6% in the LY-CoV555 group and 6.3% in the placebo group.
CONCLUSIONS


In this interim analysis of a phase 2 trial, one of three doses of neutralizing antibody LY-CoV555 appeared to accelerate the natural decline in viral load over time, whereas the other doses had not by day 11. (Funded by Eli Lilly; BLAZE-1 ClinicalTrials.gov number, NCT04427501.).",2021,"On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo.","['outpatients with recently diagnosed mild or moderate Covid-19, we randomly assigned 452 patients to receive a', 'Outpatients with Covid-19']","['placebo', 'single intravenous infusion of neutralizing antibody LY-CoV555']","['severity of symptoms', 'viral load', 'Covid-19-related hospitalization or visit to an emergency department']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]",452.0,0.572537,"On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nirula', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Heller', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Boscia', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Huhn', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cardona', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Mocherla', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Stosor', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Shawa', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Adams', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Van Naarden', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Custer', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Durante', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Oakley', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Schade', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Sabo', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Dipak R', 'Initials': 'DR', 'LastName': 'Patel', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Skovronsky', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2029849']
182,33130153,Cognitive Behavior Therapy Tailored to Anxiety Symptoms Improves Pediatric Functional Abdominal Pain Outcomes: A Randomized Clinical Trial.,"OBJECTIVES


To evaluate the feasibility of a stepped care model, and establish the effect of a tailored cognitive behavioral therapy, the Aim to Decrease Anxiety and Pain Treatment (ADAPT), compared with standard medical treatment as usual on pain-related outcomes and anxiety.
STUDY DESIGN


Eligible patients between the ages of 9 and 14 years with functional abdominal pain disorders (n = 139) received enhanced usual care during their medical visit to a gastroenterologist. Those that failed to respond to enhanced usual care were randomized to receive either a tailored cognitive behavioral therapy (ADAPT) plus medical treatment as usual, or medical treatment as usual only. ADAPT dose (4 sessions of pain management or 6 sessions of pain and anxiety management) was based on presence of clinically significant anxiety. Outcomes included feasibility, based on recruitment and retention rates. Response to ADAPT plus medical treatment as usual vs medical treatment as usual on pain-related outcomes and anxiety measures was also investigated using a structural equation modeling equivalent of a MANCOVA. Anxiety levels and ADAPT dose as moderators of treatment effects were also explored.
RESULTS


Based on recruitment and retention rates, stepped care was feasible. Enhanced usual care was effective for only 8% of youth. Participants randomized to ADAPT plus medical treatment as usual showed significantly greater improvements in pain-related disability, but not pain levels, and greater improvements in anxiety symptoms compared with those randomized to medical treatment as usual only. Anxiety and ADAPT treatment dose did not moderate the effect of treatment on disability nor pain.
CONCLUSIONS


Tailoring care based on patient need may be optimal for maximizing the use of limited psychotherapeutic resources while enhancing care.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03134950.",2021,"Participants randomized to ADAPT+TAU showed significantly greater improvements in pain-related disability, but not pain levels, and greater improvements in anxiety symptoms compared with those randomized to TAU only.",['Eligible patients between the ages of 9 and 14 years with FAPD (n = 139) received'],"['tailored CBT (ADAPT) plus TAU, or TAU only', 'tailored cognitive behavioral therapy (CBT', 'ADAPT+TAU', 'Cognitive Behavior Therapy', 'ADAPT+TAU versus TAU', 'enhanced usual care (EUC', 'EUC']","['pain-related outcomes and anxiety measures', 'Pediatric Functional Abdominal Pain Outcomes', 'pain levels', 'anxiety symptoms', 'disability nor pain', 'feasibility, based on recruitment and retention rates', 'Anxiety levels', 'pain-related disability', 'Anxiety Symptoms', 'Anxiety and Pain Treatment (ADAPT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191072', 'cui_str': '139'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.0698022,"Participants randomized to ADAPT+TAU showed significantly greater improvements in pain-related disability, but not pain levels, and greater improvements in anxiety symptoms compared with those randomized to TAU only.","[{'ForeName': 'Natoshia R', 'Initials': 'NR', 'LastName': 'Cunningham', 'Affiliation': 'Department of Family Medicine, Michigan State University, Grand Rapids, MI. Electronic address: natoshia@msu.edu.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kalomiris', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peugh', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farrell', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH; Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Pentiuk', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH; Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mallon', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH; Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Le', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Moorman', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fussner', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Richa Aggarwal', 'Initials': 'RA', 'LastName': 'Dutta', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Kashikar-Zuck', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.10.060']
183,33115783,"Diet-Associated Inflammation Modulates Inflammation and WNT Signaling in the Rectal Mucosa, and the Response to Supplementation with Dietary Fiber.","Inflammation drives colorectal cancer development, and colorectal cancer risk is influenced by dietary factors, including dietary fiber. Hyperactive WNT signaling occurs in colorectal cancer and may regulate inflammation. This study investigated (i) relationships between the inflammatory potential of diet, assessed using the Energy-adjusted Dietary Inflammatory Index (E-DII), and markers of WNT signaling, and (ii) whether DII status modulated the response to supplementation with two types of dietary fiber. Seventy-five healthy participants were supplemented with resistant starch and/or polydextrose (PD) or placebo for 50 days. Rectal biopsies were collected before and after intervention and used to assess WNT pathway gene expression and crypt cell proliferation. E-DII scores were calculated from food frequency questionnaire data. High-sensitivity C-reactive protein (hsCRP) and fecal calprotectin concentrations were quantified. hsCRP concentration was significantly greater in participants with higher E-DII scores [least square means (LSM) 4.7 vs. 2.4 mg/L,  P  = 0.03]. Baseline E-DII score correlated with  FOSL1  ( β  = 0.503,  P  = 0.003) and  WNT11  ( β  = 0.472,  P  = 0.006) expression, after adjusting for age, gender, body mass index, endoscopy procedure, and smoking status.  WNT11  expression was more than 2-fold greater in individuals with higher E-DII scores (LSM 0.131 vs. 0.059,  P  = 0.002). Baseline E-DII modulated the effects of PD supplementation on  FOSL1  expression ( P  = 0.04). More proinflammatory diets were associated with altered WNT signaling and appeared to modulate the effects of PD supplementation on expression of  FOSL1  This is the first study to investigate relationships between the E-DII and molecular markers of WNT signaling in rectal tissue of healthy individuals. Prevention Relevance:  Our finding that more inflammatory dietary components may impact large bowel health through effects on a well-recognized pathway involved in cancer development will strengthen the evidence base for dietary advice to help prevent bowel cancer.",2021,Baseline E-DII modulated the effects of PD supplementation on FOSL1 expression (P=0.04).,"['Seventy-five healthy participants', 'rectal tissue of healthy individuals']","['PD supplementation', 'resistant starch (RS) and/or polydextrose (PD) or placebo']","['WNT11 expression', 'hsCRP concentration', 'High-sensitivity C-reactive protein (hsCRP) and faecal calprotectin concentrations', 'E-DII scores', 'Baseline E-DII score', 'FOSL1 expression']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0071545', 'cui_str': 'polydextrose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1442821', 'cui_str': 'FOSL1 protein, human'}]",75.0,0.0442883,Baseline E-DII modulated the effects of PD supplementation on FOSL1 expression (P=0.04).,"[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Malcomson', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Framlington Place, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Naomi D', 'Initials': 'ND', 'LastName': 'Willis', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Framlington Place, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'McCallum', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, United Kingdom.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Framlington Place, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Shivappa', 'Affiliation': 'Department of Epidemiology and Biostatistics and Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Wirth', 'Affiliation': 'Department of Epidemiology and Biostatistics and Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hébert', 'Affiliation': 'Department of Epidemiology and Biostatistics and Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Betul', 'Initials': 'B', 'LastName': 'Kocaadam-Bozkurt', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Framlington Place, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Aycil', 'Initials': 'A', 'LastName': 'Özturan-Sirin', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Framlington Place, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Seamus B', 'Initials': 'SB', 'LastName': 'Kelly', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, United Kingdom.'}, {'ForeName': 'D Michael', 'Initials': 'DM', 'LastName': 'Bradburn', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, Ashington, United Kingdom.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Belshaw', 'Affiliation': 'University of East Anglia, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Johnson', 'Affiliation': 'Quadram Institute, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Framlington Place, Newcastle upon Tyne, United Kingdom. john.mathers@ncl.ac.uk.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0335']
184,33131164,Effect of vitamin D and/or omega-3 fatty acid supplementation on stroke outcomes: A randomized trial.,"BACKGROUND AND PURPOSE


Among stroke patients, low serum 25-hydroxyvitamin D predicts poor outcomes. In mice, higher omega-3 (n-3) fatty acid intake diminishes brain damage after stroke. In this study, we tested whether vitamin D or n-3 fatty acids supplementation prior to stroke reduces the risk of functional limitations and physical disability after stroke.
METHODS


We used data from VITAL (the VITamin D and OmegA-3 TriaL) which randomized middle-aged and older men and women without cardiovascular disease to vitamin D 3  (2000 IU/day) and/or marine n-3 fatty acids (1 g/day) and followed them for incident stroke events. Individuals experiencing a non-fatal stroke were mailed questionnaires assessing functional limitations (the physical performance scale adapted from Nagi) and physical disability (the modified Katz Activities of Daily Living and Rosow-Breslau Functional Health scales). We used logistic regression to analyze associations between randomized treatment and limitations on each scale.
RESULTS


A total of 290 individuals experienced their first stroke during the trial, of whom 197 stroke survivors completed the stroke outcomes questionnaire a median of 1.4 years after diagnosis. We observed no associations between randomized treatment to vitamin D and functional limitations (odds ratio [OR] 1.01, 95% confidence interval [CI] 0.52, 1.97) or physical disability (Rosow-Breslau scale: OR 0.92, 95% CI 0.50, 1.67; Katz scale: OR 1.03, 95% CI 0.31, 3.42). Those randomized to n-3 fatty acids had a non-significantly lower risk of functional limitations (OR 0.55, 95% CI 0.28, 1.09) and physical disability (Rosow-Breslau scale: OR 0.56, 95% CI 0.31, 1.02; Katz sclae: OR 0.32, 95% CI 0.50, 1.67).
CONCLUSION


Vitamin D or omega-3 fatty acid supplementation prior to stroke did not result in significantly improved post-stroke outcomes.",2021,Individuals experiencing a non-fatal stroke were mailed questionnaires assessing functional limitations (the physical performance scale adapted from Nagi) and physical disability (the modified Katz Activities of Daily Living and Rosow-Breslau Functional Health scales).,"['197 stroke survivors', 'Individuals experiencing a non-fatal stroke', '290 individuals experienced their first stroke during the trial', 'middle-aged and older men and women without cardiovascular disease to vitamin D 3  (2000 IU/day) and/or', '1 g/day) and followed them for incident stroke events']","['vitamin D and/or omega-3 fatty acid supplementation', 'omega-3 (n-3) fatty acid intake', 'Vitamin D or omega-3 fatty acids supplementation', 'VITamin D', 'marine n-3 fatty acids', 'vitamin D or n-3']","['physical disability (the modified Katz Activities of Daily Living and Rosow-Breslau Functional Health scales', 'risk of functional limitations', 'stroke outcomes questionnaire', 'stroke outcomes', 'physical disability']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0524645', 'cui_str': 'Marines'}]","[{'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451239', 'cui_str': 'Katz activities of daily living'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",197.0,0.240013,Individuals experiencing a non-fatal stroke were mailed questionnaires assessing functional limitations (the physical performance scale adapted from Nagi) and physical disability (the modified Katz Activities of Daily Living and Rosow-Breslau Functional Health scales).,"[{'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Rist', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rexrode', 'Affiliation': ""Division of Women's Health, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}]",European journal of neurology,['10.1111/ene.14623']
185,33119435,The mnemic neglect effect and information about dementia: age differences in recall.,"Dementia represents a more immediate threat for older than for younger adults. Consequently, different strategies may be used to defend the self against the threat of dementia. We hypothesised that older (compared to younger) adults are more likely to manifest mnemic neglect (in which information that is threatening to the self is selectively forgotten) to reduce distress for dementia-related information.Fifty-nine participants aged under 50 and 44 participants aged over 50 recalled 24 dementia-related statements that were either high or low in negativity. Participants were randomised to recall statements that referred either to themselves or another person. High-negativity, self-referent statements had the most substantial threat potential. The recall of older (but not younger) participants for high-negativity (vs. low-negativity) dementia-related statements was impaired when these statements referred to the self rather than to another person. These results indicate that older adults evince mnemic neglect in response to self-threatening information about dementia.",2022,Fifty-nine participants aged under 50 and 44 participants aged over 50 recalled 24 dementia-related statements that were either high or low in negativity.,"['older (compared to younger) adults', 'Fifty-nine participants aged under 50 and 44 participants aged over 50 recalled 24 dementia-related statements that were either high or low in negativity']",[],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",[],[],,0.0449115,Fifty-nine participants aged under 50 and 44 participants aged over 50 recalled 24 dementia-related statements that were either high or low in negativity.,"[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Cheston', 'Affiliation': 'Department of Health and Social Sciences, University of the West of England, Frenchay Campus, Bristol, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dodd', 'Affiliation': 'Department of Health and Social Sciences, University of the West of England, Frenchay Campus, Bristol, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Christopher', 'Affiliation': 'Department of Health and Social Sciences, University of the West of England, Frenchay Campus, Bristol, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wildschut', 'Affiliation': 'School of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Sedikides', 'Affiliation': 'School of Psychology, University of Southampton, Southampton, UK.'}]","Neuropsychology, development, and cognition. Section B, Aging, neuropsychology and cognition",['10.1080/13825585.2020.1842850']
186,33126825,Altered Antibody Responses in Persons Infected with HIV-1 While Using Preexposure Prophylaxis.,"Preexposure prophylaxis (PrEP) is an effective HIV prevention tool, although effectiveness is dependent upon adherence. It is important to characterize the impact of PrEP on HIV antibody responses in people who experience breakthrough infections to understand the potential impact on timely diagnosis and treatment. Longitudinal HIV-1-specific antibody responses were evaluated in 42 people who inject drugs (PWID) from the Bangkok Tenofovir Study (BTS) (placebo = 28; PrEP = 14) who acquired HIV while receiving PrEP. HIV-1 antibody levels and avidity to three envelope proteins (gp41, gp160, and gp120) were measured in the plasma using a customized Bio-Plex (Bio-Rad Laboratories, Hercules, CA) assay. A time-to-event analysis was performed for each biomarker to compare the distribution of times at which study subjects exceeded the recent/long-term assay threshold, comparing PrEP and placebo treatment groups. We fit mixed-effects models to identify longitudinal differences in antibody levels and avidity between groups. Overall, longitudinal antibody levels and avidity were notably lower in the PrEP breakthrough group compared to the placebo group. Time-to-event analyses demonstrated a difference in time to antibody reactivity between treatment groups for all Bio-Plex biomarkers. Longitudinal gp120 antibody levels within the PrEP breakthrough group were decreased compared to the placebo group. When accounting for PrEP adherence, both gp120 and gp160 antibody levels were lower in the PrEP breakthrough group compared to the placebo group. We demonstrate hindered envelope antibody maturation in PWID who became infected while receiving PrEP in the BTS, which has significant implications for HIV diagnosis. Delayed maturation of the antibody response to HIV may increase the time to detection for antibody-based tests. Clinical Trial Registration Number, NCT00119106.",2021,"When accounting for PrEP adherence, both gp120 and gp160 antibody levels were lower in the PrEP breakthrough group compared to the placebo group.
","['Persons Infected with HIV-1', '42 people who inject drugs (PWID) from the Bangkok Tenofovir Study (placebo=28; PrEP=14) who acquired HIV while receiving PrEP']","['Pre-exposure prophylaxis (PrEP', 'placebo', 'PrEP']","['HIV-1 antibody levels and avidity to three envelope proteins (gp41, gp160, and gp120', 'Altered Antibody Responses', 'Longitudinal gp120 antibody levels', 'gp120 and gp160 antibody levels', 'time to antibody reactivity', 'Overall, longitudinal antibody levels and avidity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0369497', 'cui_str': 'Human immunodeficiency virus type 1 antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017278', 'cui_str': 'env Gene Products'}, {'cui': 'C0019692', 'cui_str': 'Envelope Protein gp41, HIV'}, {'cui': 'C0062790', 'cui_str': 'gp160(HIV)'}, {'cui': 'C0019691', 'cui_str': 'env Protein gp120, HIV'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",42.0,0.0388449,"When accounting for PrEP adherence, both gp120 and gp160 antibody levels were lower in the PrEP breakthrough group compared to the placebo group.
","[{'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Parker', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Khalil', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Suphak', 'Initials': 'S', 'LastName': 'Vanichseni', 'Affiliation': 'Thailand Ministry of Public Health, U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'Wanna', 'Initials': 'W', 'LastName': 'Leelawiwat', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'McNicholl', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hickey', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'J Gerardo', 'Initials': 'JG', 'LastName': 'García-Lerma', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Kachit', 'Initials': 'K', 'LastName': 'Choopanya', 'Affiliation': 'Bangkok Metropolitan Association, Bangkok, Thailand.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Curtis', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}]",AIDS research and human retroviruses,['10.1089/AID.2020.0137']
187,32692425,Adolescent cannabis and tobacco use are associated with opioid use in young adulthood-12-year longitudinal study in an urban cohort.,"BACKGROUND AND AIMS


Cannabis, tobacco and alcohol use are prevalent among youth in the United States and may be risk factors for opioid use. The current study aimed at investigating associations between developmental trajectories of cannabis, tobacco and alcohol use in adolescence and opioid use in young adulthood in an urban cohort over the span of 12 years.
DESIGN


Cohort study of adolescents originally recruited for a randomized prevention trial with yearly assessments into young adulthood.
SETTING


Nine urban elementary schools in Baltimore, MD in the United States.
PARTICIPANTS


Participants (n = 583, 86.8% African American, 54.7% male) were originally recruited as first grade students.
MEASUREMENTS


Cannabis, tobacco and alcohol use were assessed annually from ages 14-18 years and opioid use from ages 19-26. Socio-demographics were assessed at age 6. Intervention status was also randomly assigned at age 6. Gender, race, free/reduced-priced lunch and intervention status were included as covariates in individual and sequential growth models.
FINDINGS


There were significant positive associations between the cannabis use intercept at age 14 and the opioid use intercept at age 19 (beta = 1.43; P = 0.028), the tobacco use intercept at age 14 and the opioid use intercept at age 19 (beta = 0.82; P = 0.042). Specifically, more frequent use of cannabis or tobacco at age 14 was associated with more frequent use of opioids at age 19.
CONCLUSIONS


Cannabis and tobacco use in early adolescence may be risk factors for opioid use in young adulthood among African Americans living in urban areas.",2021,"Specifically, more frequent use of cannabis or tobacco at age 14 was associated with more frequent use of opioids at age 19.
","['young adulthood in an urban cohort over the span of 12\xa0years', 'young adulthood-12-year longitudinal study in an urban cohort', 'Nine urban elementary schools in Baltimore, MD in the United States', 'African Americans living in urban areas', 'Participants (n\xa0=\xa0583, 86.8% African American, 54.7% male) were originally recruited as first grade students', 'Cohort study of adolescents originally recruited for a randomized prevention trial with yearly assessments into young adulthood']",[],"['Socio-demographics', 'Cannabis, tobacco and alcohol use']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C5191355', 'cui_str': '583'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",[],"[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",,0.0279499,"Specifically, more frequent use of cannabis or tobacco at age 14 was associated with more frequent use of opioids at age 19.
","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Thrul', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Rabinowitz', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Reboussin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC,, USA.'}, {'ForeName': 'Brion S', 'Initials': 'BS', 'LastName': 'Maher', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Ialongo', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15183']
188,33155305,Multicomponent Intervention and Long-Term Disability in Older Adults: A Nonrandomized Prospective Study.,"BACKGROUND/OBJECTIVES


To evaluate the long-term association between a multicomponent intervention program and disability in socioeconomically vulnerable older adults.
DESIGN


This was a nonrandomized prospective intervention trial.
SETTING


The setting was a community.
PARTICIPANTS


Participants included older Koreans living alone or receiving government assistance from a low-income program.
INTERVENTION


The intervention was a 24-week multicomponent program compromising group exercise, nutritional supplementation, management of depression, deprescribing, and home hazard reduction (n = 187) versus usual care (n = 196).
MEASUREMENTS


The number of dependencies in 17 basic and instrumental activities of daily living was measured every 3 months for 30 months (range: 0-17; greater values indicated worse disability). Inverse probability weighting Poisson regression was used to model the number of dependencies to adjust for confounding bias and higher dropout rates of those with greater disability.
RESULTS


The study population had a mean age of 76 years, and 26% were men. During the 30-month follow up, 17 died (n = 8, intervention; n = 9, control), 62 (n = 16, intervention; n = 46, control) were institutionalized or received nursing home care, and 34 (n = 15, intervention; n = 19, control) were lost to follow up. After inverse probability weighting, the mean number of dependencies at baseline was 1.21 and 1.29 for the intervention group and the control group, respectively (P = .80). The intervention group had fewer dependencies than the control group, but the difference was attenuated over time: 1.08 versus 1.60 at 6 months (P = .04), 1.29 versus 1.87 at 12 months (P = .03), 1.62 versus 2.17 at 18 months (P = .06), 2.08 versus 2.51 at 24 months (P = .18), and 2.73 versus 2.90 at 30 months (P = .67).
CONCLUSION


A 24-week multicomponent intervention was associated with a slower progression of disability; however, the diminishing association from 24 months and beyond suggests that reassessment and intervention may be necessary. Due to a lack of randomization, our findings should be interpreted with caution.",2021,"The intervention group had fewer dependencies than the control group, but the difference was attenuated over time: 1.08 versus 1.60 at 6 months (P = .04), 1.29 versus 1.87 at 12 months (P = .03), 1.62 versus 2.17 at 18 months (P = .06), 2.08 versus 2.51 at 24 months (P = .18), and 2.73 versus 2.90 at 30 months (P = .67).
","['The study population had a mean age of 76\u2009years, and 26% were men', 'Older Adults', 'Participants included older Koreans living alone or receiving government assistance from a low-income program', 'socioeconomically vulnerable older adults']","['Multicomponent Intervention', 'multicomponent intervention program', 'multicomponent program compromising group exercise, nutritional supplementation, management of depression, deprescribing, and home hazard reduction (n = 187) versus usual care']","['mean number of dependencies', 'disability', 'slower progression of disability', 'number of dependencies in 17 basic and instrumental activities of daily living']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0439044', 'cui_str': 'Lives alone'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4517618', 'cui_str': '187'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}]",196.0,0.0345739,"The intervention group had fewer dependencies than the control group, but the difference was attenuated over time: 1.08 versus 1.60 at 6 months (P = .04), 1.29 versus 1.87 at 12 months (P = .03), 1.62 versus 2.17 at 18 months (P = .06), 2.08 versus 2.51 at 24 months (P = .18), and 2.73 versus 2.90 at 30 months (P = .67).
","[{'ForeName': 'Chan Mi', 'Initials': 'CM', 'LastName': 'Park', 'Affiliation': 'Department of Family Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Gahee', 'Initials': 'G', 'LastName': 'Oh', 'Affiliation': 'Hebrew SeniorLife, Marcus Institute for Aging Research, Boston, Massachusetts, USA.'}, {'ForeName': 'Heayon', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee-Won', 'Initials': 'HW', 'LastName': 'Jung', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eunju', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Il-Young', 'Initials': 'IY', 'LastName': 'Jang', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Hebrew SeniorLife, Marcus Institute for Aging Research, Boston, Massachusetts, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16926']
189,33179978,The Influence of Body Shape on Impressions of Sexual Traits.,"The assumptions people make from body shape can have serious implications for the well-being of the individuals inhabiting such bodies. Fat people are subject to pervasive and resilient social stigma and discrimination, leading to negative mental and physical health outcomes, including negative sexuality-related outcomes. Though previous studies have examined the personality traits attributed to, or the sexual attractiveness of, varying body shapes, no research has asked participants to make attributions of sexual traits to varying body shapes. The purpose of this study was thus to examine sexuality-related trait inferences made from body shapes. Participants ( N  = 891, 70% women,  M age  = 25.28) were randomly assigned to view 5 computer-generated 3-dimensional body models of varying shapes developed using the skinned multi-person linear model. Participants rated their sexual attraction to each body and the degree to which each of 30 traits (10 personality and 20 sexual) applied. Results demonstrated that larger bodies are generally viewed as less sexually attractive. Further, constellations of sexuality traits were predicted reliably by body shape, demonstrating that people hold sexual stereotypes about a diverse range of body shapes. This study provides an initial comprehensive demonstration of the sexuality-specific traits associated with varying body shapes.",2022,The assumptions people make from body shape can have serious implications for the well-being of the individuals inhabiting such bodies.,"['Participants ( N  = 891, 70% women,  M   age\xa0 = 25.28']",['view 5 computer-generated 3-dimensional body models of varying shapes developed using the skinned multi-person linear model'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023732', 'cui_str': 'Models, Linear'}]",[],,0.0147797,The assumptions people make from body shape can have serious implications for the well-being of the individuals inhabiting such bodies.,"[{'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Oswald', 'Affiliation': ""Departments of Psychology and Women's, Gender, & Sexuality Studies, Pennsylvania State University.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Champion', 'Affiliation': 'Department of Criminology, Simon Fraser University.'}, {'ForeName': 'Cory L', 'Initials': 'CL', 'LastName': 'Pedersen', 'Affiliation': 'Department of Psychology, Kwantlen Polytechnic University.'}]",Journal of sex research,['10.1080/00224499.2020.1841723']
190,33225801,Neuropsychological aspects of internet-based transit navigation skills in older adults.,"Older adults commonly experience difficulties efficiently searching the Internet, which can adversely affect daily functioning. This study specifically examined the neuropsychological aspects of online transit planning in 50 younger (M = 22 years) and 40 older (M = 64 years) community-dwelling adults. All participants completed a neuropsychological battery, questionnaires, and measures of Internet use and skills. Participants used a live transit planning website to complete three inter-related tasks (e.g., map a route from an airport to a specific hotel at a particular time). On a fourth Internet transit task, participants were randomized into either a support condition in which they received brief goal management training or into a control condition. Results showed that older adults were both slower and less accurate than their younger counterparts in completing the first three Internet transit tasks. Within the older adults, Internet transit accuracy showed a medium association with verbal memory, executive functions, and auditory attention, but not visuomotor speed, which was the only domain associated with Internet transit task speed in both groups. The goal management training was beneficial for plan development in younger, but not older adults. The planning supports did not impact actual Internet transit task performance in either group. Findings indicate that older adults experience difficulties quickly and accurately using a transit website to plan transportation routes, which is associated with poorer higher-order neurocognitive functions (e.g., memory). Future work might examine the benefits of established memory strategies (e.g., spaced retrieval practice) for online transit planning.",2022,Results showed that older adults were both slower and less accurate than their younger counterparts in completing the first three Internet transit tasks.,"['older adults', '50 younger (M\xa0=\xa022\xa0years) and 40 older (M\xa0=\xa064\xa0years) community-dwelling adults', 'Older adults']","['online transit planning', 'internet-based transit navigation skills']","['neuropsychological battery, questionnaires, and measures of Internet use and skills']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0451331', 'cui_str': 'Neuropsychological battery'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0237223,Results showed that older adults were both slower and less accurate than their younger counterparts in completing the first three Internet transit tasks.,"[{'ForeName': 'Savanna M', 'Initials': 'SM', 'LastName': 'Tierney', 'Affiliation': 'Department of Psychology, University of Houston Houston, TX, USA.'}, {'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Kordovski', 'Affiliation': 'Department of Psychology, University of Houston Houston, TX, USA.'}, {'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Department of Psychology, University of Houston Houston, TX, USA.'}, {'ForeName': 'Luis D', 'Initials': 'LD', 'LastName': 'Medina', 'Affiliation': 'Department of Psychology, University of Houston Houston, TX, USA.'}, {'ForeName': 'Rodica I', 'Initials': 'RI', 'LastName': 'Damian', 'Affiliation': 'Department of Psychology, University of Houston Houston, TX, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Collins', 'Affiliation': 'Department of Psychology, University of Houston Houston, TX, USA.'}, {'ForeName': 'Steven Paul', 'Initials': 'SP', 'LastName': 'Woods', 'Affiliation': 'Department of Psychology, University of Houston Houston, TX, USA.'}]","Neuropsychology, development, and cognition. Section B, Aging, neuropsychology and cognition",['10.1080/13825585.2020.1852164']
191,33241297,A Pilot Feasibility Study of Interpersonal Psychotherapy for the Prevention of Excess Weight Gain Among Adolescent Military-dependent Girls.,"INTRODUCTION


Adolescent military-dependents face unique psychosocial stressors due to their parents' careers, suggesting they may be particularly vulnerable to excess weight gain and symptoms of depression and anxiety. Despite these risk factors, there is a lack of tested preventative interventions for these youths. Given the transient nature of military family deployments, research may be hindered due to difficulty in collecting long-term prospective outcome data, particularly measured height and weight. The primary aim of this study was to examine the feasibility and acceptability of collecting body mass index (BMI, kg/m2) outcome data up to 2 years following a randomized controlled pilot trial of an adapted interpersonal psychotherapy (IPT) program aimed at preventing excess weight gain and improving psychological functioning for adolescent military-dependents. In exploratory analyses, patterns in body composition over time were examined.
MATERIALS AND METHODS


Twenty-seven adolescent military-dependent girls (baseline: Mage: 14.4 ± 1.6 years; MBMI: 30.7 ± 4.9 kg/m2; MBMI-z: 1.9 ± 0.4) participated in this study. After a baseline assessment, utilizing a computerized program to create a randomization string, girls were assigned to either an IPT or a health education (HE) program. Participants completed three follow-up visits (posttreatment, 1-year follow-up, and 2-year follow-up). Girls completed a Treatment Acceptability Questionnaire at posttreatment; at all time points, height and fasting weight were collected. For the primary aim, Fisher's exact tests examined the rate of obtained follow-up data and lost to follow-up status between the two groups, Mann-Whitney U tests examined the session attendance between groups, and treatment acceptability ratings were compared between the two groups at posttreatment using an independent samples t-test. For the exploratory aim, one-way analyses of covariance (ANCOVAs) examined the group differences in BMI at each time point, adjusting for baseline values, and paired samples t-tests examined the within-group differences at each time point relative to baseline. Using imputed data in the full intent-to-treat sample, mixed model ANCOVAs were conducted to examine the group differences over time.
RESULTS


Across both groups, girls attended an average of 72.0% of sessions. At least partial data were collected at posttreatment, 1-year follow-up, and 2-year follow-up for 96.3%, 85.2%, and 74.1% of the participants, respectively. There were no significant group differences in follow-up data collection rates, follow-up status, number of sessions attended, or treatment acceptability. BMI-z stabilized across groups, and there were no group differences in BMI-z. In adjusted ANCOVA models with imputed data, no significant group-by-time effects emerged.
CONCLUSIONS


For this randomized controlled prevention trial, long-term outcome data collection of measured BMI was possible in adolescent military-dependents and IPT was an acceptable and feasible intervention. An adequately powered trial is required to assess the efficacy of this intervention among military-dependents for obesity prevention and improvements in BMI.",2021,"There were no significant group differences in follow-up data collection rates, follow-up status, number of sessions attended, or treatment acceptability.","['adolescent military-dependents', 'Adolescent Military-dependent Girls', 'Twenty-seven adolescent military-dependent girls (baseline: Mage: 14.4\u2009±\u20091.6 years; MBMI: 30.7\u2009±\u20094.9 kg/m2; MBMI-z: 1.9\u2009±\u20090.4) participated in this study']","['adapted interpersonal psychotherapy (IPT) program', 'IPT or a health education (HE) program', 'Interpersonal Psychotherapy']","['follow-up data collection rates, follow-up status, number of sessions attended, or treatment acceptability', 'excess weight gain and improving psychological functioning', 'BMI-z']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",27.0,0.0502357,"There were no significant group differences in follow-up data collection rates, follow-up status, number of sessions attended, or treatment acceptability.","[{'ForeName': 'Abigail E', 'Initials': 'AE', 'LastName': 'Pine', 'Affiliation': 'Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences (USU), Bethesda, MD 20814, USA.'}, {'ForeName': 'Natasha A', 'Initials': 'NA', 'LastName': 'Schvey', 'Affiliation': 'Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences (USU), Bethesda, MD 20814, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Shank', 'Affiliation': 'Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences (USU), Bethesda, MD 20814, USA.'}, {'ForeName': 'Natasha L', 'Initials': 'NL', 'LastName': 'Burke', 'Affiliation': 'Department of Psychology, Fordham University, Bronx, NY 10458, USA.'}, {'ForeName': 'M K Higgins', 'Initials': 'MKH', 'LastName': 'Neyland', 'Affiliation': 'Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences (USU), Bethesda, MD 20814, USA.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Hennigan', 'Affiliation': 'Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences (USU), Bethesda, MD 20814, USA.'}, {'ForeName': 'Jami F', 'Initials': 'JF', 'LastName': 'Young', 'Affiliation': ""Department of Child and Adolescent Psychiatry, Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA.""}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Department of Psychological and Brain Sciences, Washington University in St. Louis, St. Louis, MO 63130, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Klein', 'Affiliation': 'Departments of Family Medicine and Pediatrics, USU, Bethesda, MD 20814, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Jorgensen', 'Affiliation': 'Department of Family Medicine, Fort Belvoir Community Hospital, Fort Belvoir, VA 22060, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Seehusen', 'Affiliation': 'Department of Family Medicine, Medical College of Georgia, Augusta, GA 30912, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hutchinson', 'Affiliation': 'Wade Alliance, Austin, TX 78757, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Quinlan', 'Affiliation': 'Departments of Family Medicine and Pediatrics, USU, Bethesda, MD 20814, USA.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Yanovski', 'Affiliation': 'Section on Growth and Obesity, Program in Developmental Endocrinology and Genetics, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, DHHS, Bethesda, MD 20892, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Stephens', 'Affiliation': 'Departments of Family and Community Medicine and Humanities, Pennsylvania State University, Old Main, State College, PA 16801, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Sbrocco', 'Affiliation': 'Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences (USU), Bethesda, MD 20814, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Tanofsky-Kraff', 'Affiliation': 'Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences (USU), Bethesda, MD 20814, USA.'}]",Military medicine,['10.1093/milmed/usaa514']
192,33153515,Emotional intelligence intervention in older adults to improve adaptation and reduce negative mood.,"OBJECTIVES


Emotional intelligence (EI) is a strong predictor of negative mood. Applying emotional skills correctly can help to increase positive emotional states and reduce negative ones. This study aims to implement EI intervention designed to improve clarity, repair EI dimensions and coping strategies, and reduce negative mood in older adults.
DESIGN


Participants were randomly assigned to the treatment or control group.
SETTING


Participants were evaluated individually before and after the intervention.
PARTICIPANTS


Participants included 111 healthy older adults; 51 in the treatment group and 60 in the control group.
INTERVENTION


An EI program was implemented. The program was administered over 10 sessions lasting 90 min each.
MEASUREMENTS


EI dimension (attention, clarity, and repair), coping strategies, hopelessness, and mood were assessed.
RESULTS


Analysis of variance for repeated measures was applied. In the treatment group, scores on clarity and emotional repair increased and attention to emotions decreased; problem-focused coping (problem-solving, positive reappraisal, and seeking social support) showed significant increases, whereas emotion-focused coping (negative self-focused and overt emotional expression) obtained significant decreases; scores on negative mood measures declined significantly.
CONCLUSIONS


An intervention based on EI is effective in older adults. After the EI intervention, the participants showed significant increases in their levels of clarity and emotional repair and intermediate levels of attention. In addition, the intervention was found to influence adaptation results, increasing the use of adaptive coping strategies and decreasing the use of maladaptive strategies, as well as reducing hopelessness and depressive symptoms.",2022,"After the EI intervention, the participants showed significant increases in their levels of clarity and emotional repair and intermediate levels of attention.","['older adults', 'Participants were evaluated individually before and after the intervention', 'Participants included 111 healthy older adults; 51 in the treatment group and 60 in the control group']",['Emotional intelligence intervention'],"['positive emotional states', 'negative mood measures', 'scores on clarity and emotional repair increased and attention to emotions decreased; problem-focused coping (problem-solving, positive reappraisal, and seeking social support', 'hopelessness and depressive symptoms', 'emotion-focused coping (negative self-focused and overt emotional expression', 'EI dimension (attention, clarity, and repair), coping strategies, hopelessness, and mood', 'levels of clarity and emotional repair and intermediate levels of attention']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1510539', 'cui_str': 'Emotional Intelligence'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1510539', 'cui_str': 'Emotional Intelligence'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]",111.0,0.0186019,"After the EI intervention, the participants showed significant increases in their levels of clarity and emotional repair and intermediate levels of attention.","[{'ForeName': 'Iraida', 'Initials': 'I', 'LastName': 'Delhom', 'Affiliation': 'Universidad Internacional de Valencia (Spain), Pintor Sorolla, 21, Valencia, 46002, Spain.'}, {'ForeName': 'Encarnación', 'Initials': 'E', 'LastName': 'Satorres', 'Affiliation': 'Department of Developmental Psychology, Faculty of Psychology, University of Valencia (Spain), Av. Blasco Ibañez 21, Valencia, ES 46010, Spain.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Meléndez', 'Affiliation': 'Department of Developmental Psychology, Faculty of Psychology, University of Valencia (Spain), Av. Blasco Ibañez 21, Valencia, ES 46010, Spain.'}]",International psychogeriatrics,['10.1017/S1041610220003579']
193,33179572,Pilot Study of Compassion Meditation Training to Improve Well-being Among Older Adults.,"OBJECTIVES


Compassion meditation (CM) training has demonstrated potential in improving well-being and psychosocial functioning. However, most prior studies of CM training have focused on younger adults. The generalizability of the effectiveness of CM training with older adults requires further study. This pilot study was intended to inform future randomized controlled studies of CM training in older adults.
METHODS


Participants included 24 older adults who attended a 10-week group CM training. Exploratory outcome measures were administered prior to, during, and after the intervention. Participants also completed logs of mood and meditation practice, and provided descriptive comments in response to open-ended questions administered at the end of treatment.
RESULTS


High treatment completion rates (87.5%) and reported adherence (85.7% of assigned meditation) were observed. Descriptive feedback from participants indicated older adults are interested in and capable of learning and applying new concepts and skills in support of their well-being. Pre- to post-intervention changes were explored with a variety of self-report measures. Weekly journals suggested increased feelings of love, closeness, or trust, and decreased feelings of stress, nervousness, or being overwhelmed.
CONCLUSIONS


These findings provide preliminary support for the feasibility of CM training in community-dwelling older adults, and suggest the need for future efficacy and effectiveness clinical trials.
CLINICAL IMPLICATIONS


CM training offers potential benefits for improving well-being among older adults, and, as an example of a strengths-based approach, can be tailored to the specific needs of older adults.",2022,"RESULTS


High treatment completion rates (87.5%) and reported adherence (85.7% of assigned meditation) were observed.","['older adults', 'community-dwelling older adults', 'Participants included 24 older adults who attended a 10-week group CM training', 'Older Adults', 'participants indicated older adults']","['CM training', 'Compassion Meditation Training', 'Compassion meditation (CM) training']","['feelings of love, closeness, or trust, and decreased feelings of stress, nervousness, or being overwhelmed', 'adherence']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",24.0,0.030659,"RESULTS


High treatment completion rates (87.5%) and reported adherence (85.7% of assigned meditation) were observed.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Malaktaris', 'Affiliation': 'Center of Excellence for Stress and Mental Health, Veterans Affairs San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Ariel J', 'Initials': 'AJ', 'LastName': 'Lang', 'Affiliation': 'Center of Excellence for Stress and Mental Health, Veterans Affairs San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Casmar', 'Affiliation': 'Center of Excellence for Stress and Mental Health, Veterans Affairs San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Selena', 'Initials': 'S', 'LastName': 'Baca', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, La Jolla California, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hurst', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla California, USA.'}, {'ForeName': 'Dilip V', 'Initials': 'DV', 'LastName': 'Jeste', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, California, USA.'}, {'ForeName': 'Barton W', 'Initials': 'BW', 'LastName': 'Palmer', 'Affiliation': 'Center of Excellence for Stress and Mental Health, Veterans Affairs San Diego Healthcare System, San Diego, California, USA.'}]",Clinical gerontologist,['10.1080/07317115.2020.1839826']
194,33189747,Limitations of Conventional Magnetic Resonance Imaging as a Predictor of Death or Disability Following Neonatal Hypoxic-Ischemic Encephalopathy in the Late Hypothermia Trial.,"OBJECTIVE


To investigate if magnetic resonance imaging (MRI) is an accurate predictor for death or moderate-severe disability at 18-22 months of age among infants with neonatal encephalopathy in a trial of cooling initiated at 6-24 hours.
STUDY DESIGN


Subgroup analysis of infants ≥36 weeks of gestation with moderate-severe neonatal encephalopathy randomized at 6-24 postnatal hours to hypothermia or usual care in a multicenter trial of late hypothermia. MRI scans were performed per each center's practice and interpreted by 2 central readers using the Eunice Kennedy Shriver National Institute of Child Health and Human Development injury score (6 levels, normal to hemispheric devastation). Neurodevelopmental outcomes were assessed at 18-22 months of age.
RESULTS


Of 168 enrollees, 128 had an interpretable MRI and were seen in follow-up (n = 119) or died (n = 9). MRI findings were predominantly acute injury and did not differ by cooling treatment. At 18-22 months, death or severe disability occurred in 20.3%. No infant had moderate disability. Agreement between central readers was moderate (weighted kappa 0.56, 95% CI 0.45-0.67). The adjusted odds of death or severe disability increased 3.7-fold (95% CI 1.8-7.9) for each increment of injury score. The area under the curve for severe MRI patterns to predict death or severe disability was 0.77 and the positive and negative predictive values were 36% and 100%, respectively.
CONCLUSIONS


MRI injury scores were associated with neurodevelopmental outcome at 18-22 months among infants in the Late Hypothermia Trial. However, the results suggest caution when using qualitative interpretations of MRI images to provide prognostic information to families following perinatal hypoxia-ischemia.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT00614744.",2021,The adjusted odds of death or severe disability increased 3.7-fold (95% confidence interval 1.8-7.9) for each increment of injury score.,"['Sub-group analysis of infants ≥ 36 weeks of gestation with moderate-severe neonatal encephalopathy randomized at 6-24 postnatal hours to hypothermia or usual care in a multicenter trial of late hypothermia', 'death or moderate-severe disability at 18-22 months of age among infants with neonatal encephalopathy in a trial of cooling initiated at 6-24 hours', '168 enrollees']","['Conventional Magnetic Resonance Imaging', 'magnetic resonance imaging (MRI']","['death or severe disability', 'adjusted odds of death or severe disability', 'Neurodevelopmental outcomes', 'MRI injury scores', 'moderate disability', 'Death or Disability']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C4319556', 'cui_str': '168'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.330788,The adjusted odds of death or severe disability increased 3.7-fold (95% confidence interval 1.8-7.9) for each increment of injury score.,"[{'ForeName': 'Abbot R', 'Initials': 'AR', 'LastName': 'Laptook', 'Affiliation': 'Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI. Electronic address: alaptook@wihri.org.'}, {'ForeName': 'Seetha', 'Initials': 'S', 'LastName': 'Shankaran', 'Affiliation': 'Department of Pediatrics, Wayne State University, Detroit, MI.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Barnes', 'Affiliation': 'Department of Radiology and Pediatrics, Stanford University School of Medicine, Palo Alto, CA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Rollins', 'Affiliation': 'Department of Radiology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Barbara T', 'Initials': 'BT', 'LastName': 'Do', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Nehal A', 'Initials': 'NA', 'LastName': 'Parikh', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hamrick', 'Affiliation': ""Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta, GA.""}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Hintz', 'Affiliation': ""Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA.""}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Tyson', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Bell', 'Affiliation': 'Department of Pediatrics, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Ronald N', 'Initials': 'RN', 'LastName': 'Goldberg', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Pappas', 'Affiliation': 'Department of Pediatrics, Wayne State University, Detroit, MI.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Huitema', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, MD.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Aasma S', 'Initials': 'AS', 'LastName': 'Chaudhary', 'Affiliation': 'Department of Pediatrics, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Angelita M', 'Initials': 'AM', 'LastName': 'Hensman', 'Affiliation': 'Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, MD.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Wyckoff', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': ""Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA.""}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Walsh', 'Affiliation': ""Department of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH.""}, {'ForeName': 'Kristi L', 'Initials': 'KL', 'LastName': 'Watterberg', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Faix', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Truog', 'Affiliation': ""Department of Pediatrics, Children's Mercy Hospital and University of Missouri Kansas City School of Medicine, Kansas City, MO.""}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Guillet', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Sokol', 'Affiliation': 'Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Brenda B', 'Initials': 'BB', 'LastName': 'Poindexter', 'Affiliation': ""Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN; Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Rosemary D', 'Initials': 'RD', 'LastName': 'Higgins', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Pregnancy and Perinatology Branch, Bethesda, MD; George Mason University, Fairfax, VA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.11.015']
195,33227157,Mindfulness in Motion and Dietary Approaches to Stop Hypertension (DASH) in Hypertensive African Americans.,"OBJECTIVES


Hypertension increases the risk of developing Alzheimer's disease or related dementias. This pilot study's purpose was to examine the feasibility and acceptability of a novel intervention, Mindfulness in Motion (MIM) and Dietary Approaches to Stop Hypertension DASH (MIM DASH), to improve diet, mindfulness, stress, and systolic blood pressure (BP) in older African Americans with mild cognitive impairment (MCI) and hypertension.
DESIGN


Cluster randomized controlled trial.
SETTING


Intergenerational community center in a large metropolitan area.
PARTICIPANTS


African Americans with MCI and hypertension. Participants were divided into six groups randomized 1:1:1 to the MIM DASH group, attention only (non-hypertensive education) group, or true control group. The MIM DASH and attention only interventions were delivered in 8-weekly 2 hour group sessions. MIM included mindful movements from chair/standing, breathing exercises, and guided meditation. The DASH component used a critical thinking approach of problem solving, goal setting, reflection, and self-efficacy. The true control group received a DASH pamphlet at the end.
MEASUREMENTS


Feasibility was tracked through enrollment and attendance records; acceptability was assessed through interviews. Blood pressure was measured using the Omron HEM-907XL Monitor. Dietary intake was measured by DASH-Q. Mindfulness was measured by the Cognitive and Affective Mindfulness Scale. Stress was measured by the Perceived Stress Scale. MCI was determined using the Self-Administered Gerocognitive Examination. Data were collected at baseline and 3-months.
RESULTS


Median session attendance was six for the MIM DASH group and six for the attention only group. There were no changes in diet, mindfulness, or stress. There was a clinically significant reduction in systolic BP in the MIM DASH group (-7.2 mmHg) relative to the attention only group (-.7), and no change between the MIM DASH and true control groups.
CONCLUSION


Results indicate that the MIM DASH intervention was feasible and culturally acceptable in African Americans with hypertension and MCI.",2021,"There was a clinically significant reduction in systolic BP in the MIM DASH group (-7.2 mmHg) relative to the attention only group (-.7), and no change between the MIM DASH and true control groups.
","['older African Americans with mild cognitive impairment (MCI) and hypertension', 'Hypertensive African Americans', 'African Americans with hypertension and MCI', 'African Americans with MCI and hypertension', 'Intergenerational community center in a large metropolitan area']","['DASH pamphlet', 'MIM DASH intervention', 'MIM DASH group, attention only (non-hypertensive education) group, or true control group', 'MIM DASH', 'Mindfulness in Motion and Dietary Approaches to Stop Hypertension (DASH', 'novel intervention, Mindfulness in Motion (MIM) and Dietary Approaches to Stop Hypertension DASH (MIM DASH']","['feasibility and acceptability', 'Perceived Stress Scale', 'MIM included mindful movements from chair/standing, breathing exercises, and guided meditation', 'DASH-Q. Mindfulness', 'Cognitive and Affective Mindfulness Scale', 'Dietary intake', 'Blood pressure', 'systolic BP', 'diet, mindfulness, or stress', 'diet, mindfulness, stress, and systolic blood pressure (BP']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.0147637,"There was a clinically significant reduction in systolic BP in the MIM DASH group (-7.2 mmHg) relative to the attention only group (-.7), and no change between the MIM DASH and true control groups.
","[{'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Wright', 'Affiliation': 'College of Nursing, Center of Excellence in Critical and Complex Care, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Maryanna D', 'Initials': 'MD', 'LastName': 'Klatt', 'Affiliation': 'Department of Family and Community Medicine, The Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Ingrid Richards', 'Initials': 'IR', 'LastName': 'Adams', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Nguyen', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Lorraine C', 'Initials': 'LC', 'LastName': 'Mion', 'Affiliation': 'College of Nursing, Center of Excellence in Critical and Complex Care, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Alai', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'College of Nursing, Center of Excellence in Critical and Complex Care, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Todd B', 'Initials': 'TB', 'LastName': 'Monroe', 'Affiliation': 'College of Nursing, Center of Excellence in Critical and Complex Care, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Rose', 'Affiliation': 'College of Nursing, Center of Excellence in Critical and Complex Care, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Scharre', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, Ohio, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16947']
196,32692990,Liposomal Bupivacaine Local Infiltration for Buccal Mucosal Graft Harvest Site Pain Control: A Single-blinded Randomized Controlled Trial.,"OBJECTIVE


To assess efficacy and safety of liposomal bupivacaine (LB) infiltration of the buccal mucosal graft (BMG) harvest site in alleviating pain by evaluating the postoperative narcotic usage, pain score, and morbidities.
PATIENTS AND METHODS


Single-blinded randomized controlled trial of 43 adult patients for BMG substitution urethroplasty between January 2015 to June 2017 (Clinicaltrials.gov: NCT03720223). A computer-generated allocation scheme randomized patients to control group (n = 22) no further local anesthetic infiltration aside from that of used in the hydrodissection for BMG harvest, and to intervention group with additional infiltration of LB to BMG harvest site (n = 21). We assessed postoperative cumulative narcotic use on post-op day 1 and 2 (24- and 48-hour total intravenous [IV] morphine equivalents in milligrams). A self-reported 10-point numeric rating scale survey was administered to assess postprocedural oral pain, oral conditions, and morbidity on days 1-3, and at 1-month follow-up. Fisher's exact test and independent T test were performed to assess differences between treatment groups. Linear regression was used to determine adjusted effect estimates of intervention.
RESULTS


Compared to controls, a significantly lower narcotic use was noticed among the LB treatment group on post-op day 1 (IV morphine equivalent mean difference 8.58 mg; 95% confidence interval 1.59, 15.56, P =.017), while no significant difference was noticed on post-op day 2. There was no significant difference between treatment groups with regards to postprocedural oral pain score or oral morbidities.
CONCLUSION


Our study showed that LB infiltration of the BMG harvest site is safe and associated with lower 24-hour narcotic use only at post-op day 1.",2020,"Compared to controls, a significantly lower narcotic use was noticed among the LB treatment group on post-op day-1","['43 adult patients for BMG substitution urethroplasty between January 2015 to June 2017', 'Buccal Mucosal Graft Harvest Site Pain Control']","['liposomal bupivacaine (LB', 'Liposomal Bupivacaine']","['narcotic use', 'postoperative cumulative narcotic', 'post-procedural oral pain score or oral morbidities']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0450135', 'cui_str': 'Mucosal graft'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0221776', 'cui_str': 'Painful mouth'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",43.0,0.0844186,"Compared to controls, a significantly lower narcotic use was noticed among the LB treatment group on post-op day-1","[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Chua', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA; Devine-Jordan Center for Reconstructive Surgery and Pelvic Health, Urology of Virginia, Virginia Beach, VA.'}, {'ForeName': 'Jack M', 'Initials': 'JM', 'LastName': 'Zuckerman', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA; Devine-Jordan Center for Reconstructive Surgery and Pelvic Health, Urology of Virginia, Virginia Beach, VA; Department of Urology, Naval Medical Center, Portsmouth, VA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Strehlow', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA; Devine-Jordan Center for Reconstructive Surgery and Pelvic Health, Urology of Virginia, Virginia Beach, VA; Spartanburg Medical Center, Spartanburg, SC.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Virasoro', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA; Devine-Jordan Center for Reconstructive Surgery and Pelvic Health, Urology of Virginia, Virginia Beach, VA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'DeLong', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA; Devine-Jordan Center for Reconstructive Surgery and Pelvic Health, Urology of Virginia, Virginia Beach, VA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Tonkin', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA; Devine-Jordan Center for Reconstructive Surgery and Pelvic Health, Urology of Virginia, Virginia Beach, VA.'}, {'ForeName': 'Kurt A', 'Initials': 'KA', 'LastName': 'McCammon', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA; Devine-Jordan Center for Reconstructive Surgery and Pelvic Health, Urology of Virginia, Virginia Beach, VA. Electronic address: mccammKa@evms.edu.'}]",Urology,['10.1016/j.urology.2020.06.067']
197,33150445,Biomechanical Response to External Biofeedback During Functional Tasks in Individuals With Chronic Ankle Instability.,"CONTEXT


Altered biomechanics displayed by individuals with chronic ankle instability (CAI) is a possible cause of recurring injuries and posttraumatic osteoarthritis. Current interventions are unable to modify aberrant biomechanics, leading to research efforts to determine if real-time external biofeedback can result in changes.
OBJECTIVE


To determine the real-time effects of visual and auditory biofeedback on functional-task biomechanics in individuals with CAI.
DESIGN


Crossover study.
SETTING


Laboratory.
PATIENTS OR OTHER PARTICIPANTS


Nineteen physically active adults with CAI (7 men, 12 women; age = 23.95 ± 5.52 years, height = 168.87 ± 6.94 cm, mass = 74.74 ± 15.41 kg).
INTERVENTION(S)


Participants randomly performed single-limb static balance, step downs, lateral hops, and forward lunges during a baseline and 2 biofeedback conditions. Visual biofeedback was given through a crossline laser secured to the dorsum of the foot. Auditory biofeedback was given through a pressure sensor placed under the lateral foot and connected to a buzzer that elicited a noise when pressure exceeded the set threshold. Cues provided during the biofeedback conditions were used to promote proper biomechanics during each task.
MAIN OUTCOME MEASURE(S)


We measured the location of center-of-pressure (COP) data points during balance with eyes open and eyes closed for each condition. Plantar pressure in the lateral column of the foot during functional tasks was extracted. Secondary outcomes of interest were COP area and velocity, time to boundary during static balance, and additional plantar-pressure measures.
RESULTS


Both biofeedback conditions reduced COP in the anterolateral quadrant while increasing COP in the posteromedial quadrant of the foot during eyes-open balance. Visual biofeedback increased lateral heel pressure and the lateral heel and midfoot pressure-time integral during hops. The auditory condition produced similar changes during the eyes-closed trials. Auditory biofeedback increased heel pressure during step downs and decreased the lateral forefoot pressure-time integral during lunges.
CONCLUSIONS


Real-time improvements in balance strategies were observed during both external biofeedback conditions. Visual and auditory biofeedback appeared to effectively moderate different functional-task biomechanics.",2021,"Visual biofeedback increased lateral heel pressure and increased lateral heel and midfoot pressure-time integral during hops.
","['individuals with CAI Design', 'Crossover study Setting: Laboratory Patients or Other Participants', 'individuals with chronic ankle instability (CAI', 'Nineteen physically active adults with CAI (23.95±5.52 years; 168.87±6.94 cm; 74.74±15.41 kg, female=12) volunteered', 'Individuals with Chronic Ankle Instability']","['Visual and auditory biofeedback', 'visual and auditory biofeedback', 'External Biofeedback', 'Auditory biofeedback', 'Visual biofeedback', 'single-leg static balance, step-downs, lateral-hops, and forward-lunges during a baseline and two biofeedback conditions']","['lateral forefoot pressure-time integral', 'COP area and velocity, time-to-boundary during static balance, and additional plantar pressure measures', 'functional task biomechanics', 'lateral heel pressure and increased lateral heel and midfoot pressure-time integral during hops', 'Plantar pressure', 'Location of center of pressure (COP) data points during balance with eyes-open and closed during each condition', 'heel pressure', 'balance strategies']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0932074', 'cui_str': 'Midfoot region of foot'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",19.0,0.0293757,"Visual biofeedback increased lateral heel pressure and increased lateral heel and midfoot pressure-time integral during hops.
","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Torp', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Charlotte.'}, {'ForeName': 'Abbey C', 'Initials': 'AC', 'LastName': 'Thomas', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Charlotte.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Hubbard-Turner', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Charlotte.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Donovan', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Charlotte.'}]",Journal of athletic training,['10.4085/197-20']
198,33169944,"Effectiveness and adverse effects of at-home dental bleaching with 37% versus 10% carbamide peroxide: A randomized, blind clinical trial.","PURPOSE


The aim of this trial was to evaluate bleaching effectiveness, tooth sensitivity and gingival irritation of whitening patients with 10% versus 37% carbamide peroxide (CP).
METHODS


Eighty patients were selected by inclusion and exclusion criteria and randomly allocated into two groups (n = 40): 37% CP and 10% CP. In both groups, patients performed whitening for 3 weeks, 4 h/day for 10% group and 30 min/day for 37% group. Color was evaluated with Vita Classical, Vita Bleachedguide 3D Master and Spectrophotometer Easyshade, at baseline, weekly and 30 days after treatment. Absolute risk and intensity of tooth sensitivity (TS) and gingival irritation (GI) were assessed with numeric rating scale (NRS) and a visual analog scale (VAS). Color changes were compared with t-test for independent samples. TS and GI were evaluated with Fisher's exact tests. Mann-Whitney test was used for NRS, and t-tests for VAS (α = 0.05).
RESULTS


The 37% CP group showed faster whitening than 10% group at 1-3 weeks. However, 1 month after conclusion, both groups showed equivalent bleaching (p = 0.06). Regarding sensitivity and gingival irritation, 10% and 37% groups met no significant differences (p > 0.05).
CONCLUSION


The use of 37% CP 30 min/day showed equivalent results to 10% 4 h/day.
CLINICAL SIGNIFICANCE


The use of 37% carbamide peroxide 30 min/day may decrease the time of tray use in at-home protocol for whitening because it presents equivalent results to 10% carbamide peroxide 4 h/day.",2022,"Regarding sensitivity and gingival irritation, 10% and 37% groups met no significant differences (p > 0.05).
","['whitening patients with 10% versus 37% carbamide peroxide (CP', 'Eighty patients were selected by inclusion and exclusion criteria and randomly allocated into two groups (n = 40): 37% CP and 10% CP']","['37% carbamide peroxide', 'carbamide peroxide']","['Absolute risk and intensity of tooth sensitivity (TS) and gingival irritation (GI', 'time of tray use', 'bleaching effectiveness, tooth sensitivity and gingival irritation', 'Effectiveness and adverse effects', 'sensitivity and gingival irritation', 'numeric rating scale (NRS) and a visual analog scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",80.0,0.0992474,"Regarding sensitivity and gingival irritation, 10% and 37% groups met no significant differences (p > 0.05).
","[{'ForeName': 'Elisama', 'Initials': 'E', 'LastName': 'Sutil', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Karine Letícia', 'Initials': 'KL', 'LastName': 'da Silva', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Renata Maria Oleniki', 'Initials': 'RMO', 'LastName': 'Terra', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Adrieli', 'Initials': 'A', 'LastName': 'Burey', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Rezende', 'Affiliation': 'School of Dentistry, School Paulo Picanço, Fortaleza, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'School of Dentistry, Department of Restorative Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12677']
199,33188301,Examining differences between overweight women and men in 12-month weight loss study comparing healthy low-carbohydrate vs. low-fat diets.,"BACKGROUND/OBJECTIVES


Biological sex factors and sociocultural gender norms affect the physiology and behavior of weight loss. However, most diet intervention studies do not report outcomes by sex, thereby impeding reproducibility. The objectives of this study were to compare 12-month changes in body weight and composition in groups defined by diet and sex, and adherence to a healthy low carbohydrate (HLC) vs. healthy low fat (HLF) diet.
PARTICIPANTS/METHODS


This was a secondary analysis of the DIETFITS trial, in which 609 overweight/obese nondiabetic participants (age, 18-50 years) were randomized to a 12-month HLC (n = 304) or HLF (n = 305) diet. Our first aim concerned comparisons in 12-month changes in weight, fat mass, and lean mass by group with appropriate adjustment for potential confounders. The second aim was to assess whether or not adherence differed by diet-sex group (HLC women n = 179, HLC men n = 125, HLF women n = 167, HLF men n = 138).
RESULTS


12-month changes in weight (p < 0.001) were different by group. HLC produced significantly greater weight loss, as well as greater loss of both fat mass and lean mass, than HLF among men [-2.98 kg (-4.47, -1.50); P < 0.001], but not among women. Men were more adherent to HLC than women (p = 0.02). Weight loss estimates within group remained similar after adjusting for adherence, suggesting adherence was not a mediator.
CONCLUSIONS


By reporting outcomes by sex significant weight loss differences were identified between HLC and HLF, which were not recognized in the original primary analysis. These findings highlight the need to consider sex in the design, analysis, and reporting of diet trials.",2021,"HLC produced significantly greater weight loss, as well as greater loss of both fat mass and lean mass, than HLF among men [-2.98 kg (-4.47, -1.50); P < 0.001], but not among women.","['125, HLF women n\u2009=\u2009167, HLF men n\u2009=\u2009138', 'women n\u2009=\u2009179, HLC men n\u2009', '609 overweight/obese nondiabetic participants (age, 18-50 years']","['HLF', 'HLC', 'diet-sex group (HLC', 'healthy low carbohydrate (HLC) vs. healthy low fat (HLF) diet', 'healthy low-carbohydrate vs. low-fat diets']","['weight', 'weight loss', 'Weight loss estimates', 'loss of both fat mass and lean mass', 'body weight and composition', 'weight, fat mass, and lean mass']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",609.0,0.0469229,"HLC produced significantly greater weight loss, as well as greater loss of both fat mass and lean mass, than HLF among men [-2.98 kg (-4.47, -1.50); P < 0.001], but not among women.","[{'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Aronica', 'Affiliation': 'Department of Medicine, Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rigdon', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Offringa', 'Affiliation': 'Department of Medicine, Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Marcia L', 'Initials': 'ML', 'LastName': 'Stefanick', 'Affiliation': 'Department of Medicine, Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Department of Medicine, Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA. cgardner@stanford.edu.'}]",International journal of obesity (2005),['10.1038/s41366-020-00708-y']
200,33220252,The Colombian Chemoprevention Trial: 20-Year Follow-Up of a Cohort of Patients With Gastric Precancerous Lesions.,"BACKGROUND & AIMS


Helicobacter pylori eradication and endoscopic surveillance of gastric precancerous lesions are strategies to reduce gastric cancer (GC) risk. To our knowledge, this study is the longest prospective cohort of an H pylori eradication trial in a Hispanic population.
METHODS


A total of 800 adults with precancerous lesions were randomized to anti-H pylori treatment or placebo. Gastric biopsy samples taken at baseline and 3, 6, 12, 16, and 20 years were assessed by our Correa histopathology score. A generalized linear mixed model with a participant-level random intercept was used to estimate the effect of H pylori status on the score over time. Logistic regression models were used to estimate progression by baseline diagnosis and to estimate GC risk by intestinal metaplasia (IM) subtype and anatomic location.
RESULTS


Overall, 356 individuals completed 20 years of follow-up. Anti-H pylori therapy (intention-to-treat) reduced progression of the Correa score (odds ratio [OR], 0.59; 95% confidence interval [CI], 0.38-0.93). H pylori-negative status had a beneficial effect on the score over time (P = .036). Among individuals with IM (including indefinite for dysplasia) at baseline, incidence rates per 100 person-years were 1.09 (95% CI, 0.85-1.33) for low-grade/high-grade dysplasia and 0.14 (95% CI, 0.06-0.22) for GC. Incomplete-type (vs complete-type) IM at baseline presented higher GC risk (OR, 13.4; 95% CI, 1.8-103.8). Individuals with corpus (vs antrum-restricted) IM showed an OR of 2.1 (95% CI, 0.7-6.6) for GC.
CONCLUSIONS


In a high-GC-risk Hispanic population, anti-H pylori therapy had a long-term beneficial effect against histologic progression. Incomplete IM is a strong predictor of GC risk.",2021,"IM at baseline presented higher GC risk (OR, 13.4; 95% CI, 1.8-103.8).","['800 adults with precancerous lesions', 'Hispanic population', 'Individuals with corpus (vs. antrum-restricted', 'patients with gastric precancerous lesions', '356 individuals completed 20 years of follow-up']",['anti-H. pylori treatment or placebo'],"['GC risk by intestinal metaplasia (IM) subtype and anatomic location', 'progression of the Correa score (odds ratio', 'GC risk']","[{'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034193', 'cui_str': 'Pyloric antrum structure'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0334037', 'cui_str': 'Intestinal metaplasia'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",800.0,0.177121,"IM at baseline presented higher GC risk (OR, 13.4; 95% CI, 1.8-103.8).","[{'ForeName': 'M Blanca', 'Initials': 'MB', 'LastName': 'Piazuelo', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee; Center for Mucosal Inflammation and Cancer, Vanderbilt University Medical Center, Nashville, Tennessee. Electronic address: maria.b.piazuelo@vumc.org.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Bravo', 'Affiliation': 'Department of Pathology, Universidad del Valle School of Medicine, Cali, Valle del Cauca, Colombia.'}, {'ForeName': 'Robertino M', 'Initials': 'RM', 'LastName': 'Mera', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'M Constanza', 'Initials': 'MC', 'LastName': 'Camargo', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Bravo', 'Affiliation': 'Department of Pathology, Universidad del Valle School of Medicine, Cali, Valle del Cauca, Colombia.'}, {'ForeName': 'Alberto G', 'Initials': 'AG', 'LastName': 'Delgado', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'M Kay', 'Initials': 'MK', 'LastName': 'Washington', 'Affiliation': 'Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Rosero', 'Affiliation': 'Universidad de Nariño, Pasto, Nariño, Colombia.'}, {'ForeName': 'Luz S', 'Initials': 'LS', 'LastName': 'Garcia', 'Affiliation': 'Department of Pathology, Universidad del Valle School of Medicine, Cali, Valle del Cauca, Colombia.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Realpe', 'Affiliation': 'Fundación Hospital San Pedro, Pasto, Nariño, Colombia.'}, {'ForeName': 'Sandra P', 'Initials': 'SP', 'LastName': 'Cifuentes', 'Affiliation': 'Fundación Hospital San Pedro, Pasto, Nariño, Colombia.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Morgan', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee; Division of Gastroenterology, Department of Medicine, University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Peek', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee; Center for Mucosal Inflammation and Cancer, Vanderbilt University Medical Center, Nashville, Tennessee; Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Pelayo', 'Initials': 'P', 'LastName': 'Correa', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Wilson', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee; Center for Mucosal Inflammation and Cancer, Vanderbilt University Medical Center, Nashville, Tennessee; Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, Tennessee; Veterans Affairs Tennessee Valley Healthcare System, Nashville, Tennessee.'}]",Gastroenterology,['10.1053/j.gastro.2020.11.017']
201,33228794,Planned early delivery versus expectant management to reduce adverse pregnancy outcomes in pre-eclampsia in a low- and middle-income setting: study protocol for a randomised controlled trial (CRADLE-4 Trial).,"BACKGROUND


Pre-eclampsia is a pregnancy complication characterised by high blood pressure and multi-organ dysfunction in the mother. It is a leading contributor to maternal and perinatal mortality, with 99% of these deaths occurring in low- and middle-income countries (LMIC). Whilst clear guidelines exist for management of early-onset (< 34 weeks) and term (≥ 37 weeks) disease, the optimal timing of delivery in pre-eclampsia between 34 + 0  and 36 + 6  weeks is less clear. In a high-income setting, delivery may improve maternal outcomes without detriment to the baby, but this intervention is yet to be evaluated in LMIC.
METHODS


The CRADLE-4 Trial is a non-masked, randomised controlled trial comparing planned early delivery (initiation of delivery within 48 h of randomisation) with routine care (expectant management) in women with pre-eclampsia between 34 + 0  and 36 + 6  weeks' gestation in India and Zambia. The primary objective is to establish whether a policy of planned early delivery can reduce adverse maternal outcomes, without increasing severe neonatal morbidity.
DISCUSSION


The World Health Organization recommends delivery for all women with pre-eclampsia from 37 weeks onwards, based on evidence showing clear maternal benefit without increased neonatal risk. Before 34 weeks, watchful waiting is preferred, with delivery recommended only when there is severe maternal or fetal compromise, due to the neonatal risks associated with early preterm delivery. Currently, there is a lack of guidance for clinicians managing women with pre-eclampsia between 34 + 0  and 36 + 6  weeks. Early delivery benefits the mother but may increase the need for neonatal unit admission in the infant (albeit without serious morbidity at this gestation). On the other hand, waiting to deliver may increase the risk of stillbirth, fetal growth restriction and hypoxic brain injury in the neonate as a result of severe maternal complications. This is especially true for LMIC where there is a higher prevalence of adverse events. The balance of risks and benefits therefore needs to be carefully assessed before making firm recommendations. This is the first trial evaluating the optimal timing of delivery in pre-eclampsia in LMIC, where resources and disease burden are considerably different.
TRIAL REGISTRATION


ISRCTN 10672137 . Registered on 28 November 2019.",2020,Early delivery benefits the mother but may increase the need for neonatal unit admission in the infant (albeit without serious morbidity at this gestation).,"[""women with pre-eclampsia between 34 +\u20090  and 36 +\u20096  weeks' gestation in India and Zambia""]","['Planned early delivery versus expectant management', 'planned early delivery (initiation of delivery within 48\u2009h of randomisation) with routine care (expectant management']","['adverse maternal outcomes', 'risk of stillbirth, fetal growth restriction and hypoxic brain injury', 'adverse pregnancy outcomes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C1140716', 'cui_str': 'Brain damage due to hypoxia'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}]",,0.255286,Early delivery benefits the mother but may increase the need for neonatal unit admission in the infant (albeit without serious morbidity at this gestation).,"[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Beardmore-Gray', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK. alice.1.beardmore-gray@kcl.ac.uk.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Vousden', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Charantimath', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, JNMC, Belagavi, Karnataka, India.""}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Katageri', 'Affiliation': ""BVV Sangha's S Nijalingappa Medical College & HSK Hospital and Research Centre, Bagalkot, Karnataka, India.""}, {'ForeName': 'Mrutyunjaya', 'Initials': 'M', 'LastName': 'Bellad', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, JNMC, Belagavi, Karnataka, India.""}, {'ForeName': 'Kunda', 'Initials': 'K', 'LastName': 'Kapembwa', 'Affiliation': 'Department of Paediatrics, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Chinkoyo', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ndola Teaching Hospital, Ndola, Zambia.'}, {'ForeName': 'Bellington', 'Initials': 'B', 'LastName': 'Vwalika', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Clark', 'Affiliation': ""Welbodi Partnership, Ola During Children's Hospital, Freetown, Sierra Leone.""}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Research Department of Primary Care and Population Health, Royal Free Campus, University College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Shivaprasad', 'Initials': 'S', 'LastName': 'Goudar', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, JNMC, Belagavi, Karnataka, India.""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}]",Trials,['10.1186/s13063-020-04888-w']
202,33172305,"Gender, HIV knowledge and prevention attitudes among adolescents living with HIV participating in an economic empowerment intervention in Uganda.","HIV disproportionately affect adolescent girls and young women in sub-Saharan Africa. In Uganda, the HIV prevalence is four times higher in adolescent girls compared to boys. This study examined gender, HIV general and clinical knowledge, and prevention attitudes among adolescents living with HIV in Uganda. Data from a cluster randomized clinical trial were analyzed. A total of 702 adolescents (average age of 12.4) were randomized to either a control arm receiving bolstered standard of care or the treatment arm receiving bolstered standard of care plus a family economic empowerment intervention to support medication adherence. Ordinary Least Squares models that adjust for clustering of adolescents within health clinics were conducted. No gender differences were observed in HIV knowledge and prevention attitudes at baseline. However, at 12-months follow-up, boys were more likely than girls to report correct HIV general knowledge  (d  = 0.21), clinical knowledge ( d  = 0.48), and favorable prevention attitudes ( d  = 0.27). The intervention was not associated with any of the outcomes. Given the high HIV prevalence among adolescents, specifically girls, there is need to develop and/or tailor existing programs and interventions that equip adolescent girls with comprehensive knowledge and prevention attitudes, that are culturally appropriate, to reduce HIV transmission and reinfection within this population.",2021,No gender differences were observed in HIV knowledge and prevention attitudes at baseline.,"['adolescents within health clinics', '702 adolescents (average age of 12.4', 'adolescents living with HIV in Uganda', 'HIV disproportionately affect adolescent girls and young women in sub-Saharan Africa', 'adolescents living with HIV participating in an economic empowerment intervention in Uganda', 'adolescent girls']",['control arm receiving bolstered standard of care or the treatment arm receiving bolstered standard of care plus a family economic empowerment intervention to support medication adherence'],"['clinical knowledge', 'favorable prevention attitudes', 'Gender, HIV knowledge and prevention attitudes', 'HIV knowledge and prevention attitudes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",702.0,0.0265133,No gender differences were observed in HIV knowledge and prevention attitudes at baseline.,"[{'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, St. Louis, MO, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, St. Louis, MO, USA.'}, {'ForeName': 'Joelynn', 'Initials': 'J', 'LastName': 'Muwanga', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, St. Louis, MO, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, St. Louis, MO, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Brathwaite', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, St. Louis, MO, USA.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Namuwonge', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, St. Louis, MO, USA.'}, {'ForeName': 'Ozge Sensoy', 'Initials': 'OS', 'LastName': 'Bahar', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, St. Louis, MO, USA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, St. Louis, MO, USA.'}]",AIDS care,['10.1080/09540121.2020.1844860']
203,33229339,Effects of Supplemental Calcium and Vitamin D on Circulating Biomarkers of Gut Barrier Function in Patients with Colon Adenoma: A Randomized Clinical Trial.,"Gut barrier dysfunction promotes chronic inflammation, contributing to several gastrointestinal diseases, including colorectal cancer. Preliminary evidence suggests that vitamin D and calcium could prevent colorectal carcinogenesis, in part, by influencing gut barrier function. However, relevant human data are scarce. We tested the effects of supplemental calcium (1,200 mg/day) and/or vitamin D 3  (1,000 IU/day) on circulating concentrations of biomarkers of gut permeability (anti-flagellin and anti-lipopolysaccharide IgA and IgG, measured via ELISA) from baseline to 1 and 3 or 5 years postbaseline among 175 patients with colorectal adenoma in a randomized, double-blinded, placebo-controlled clinical trial. We also assessed factors associated with baseline concentrations of these biomarkers. We found no appreciable effects of supplemental vitamin D 3  and/or calcium on individual or aggregate biomarkers of gut permeability. At baseline, a combined permeability score (the summed concentrations of all four biomarkers) was 14% lower among women ( P  = 0.01) and 10% higher among those who consumed >1 serving per day of red or processed meats relative to those who consumed none ( P   trend  = 0.03). The permeability score was estimated to be 49% higher among participants with a body mass index (BMI) > 35 kg/m 2  relative to those with a BMI < 22.5 kg/m 2  ( P   trend  = 0.17). Our results suggest that daily supplemental vitamin D 3  and/or calcium may not modify circulating concentrations of gut permeability biomarkers within 1 or 3-5 years, but support continued investigation of modifiable factors, such as diet and excess adiposity, that could affect gut permeability. PREVENTION RELEVANCE: Calcium and vitamin D may be involved in regulating and maintaining the integrity of the intestinal mucosal barrier, the dysfunction of which results in exposure of the host to luminal bacteria, endotoxins, and antigens leading to potentially cancer-promoting endotoxemia and chronic colon inflammation. While our results suggest that daily supplementation with these chemopreventive agents does not modify circulating concentrations of gut permeability biomarkers, they support continued investigation of other potential modifiable factors, such as diet and excess adiposity, that could alter gut barrier function, to inform the development of treatable biomarkers of risk for colorectal neoplasms and effective colon cancer preventive strategies.",2021,"At baseline, a combined permeability score (the summed concentrations of all four biomarkers) was 14% lower among women (P = 0.01) and 10% higher among those who consumed >1 serving/day of red or processed meats relative to those who consumed none (Ptrend = 0.03).","['175 colorectal adenoma patients', 'Colon Adenoma Patients']","['placebo', 'Supplemental Calcium and Vitamin D', 'supplemental vitamin D3 and/or calcium', 'vitamin D and calcium', 'supplemental calcium', 'vitamin D3']","['colorectal carcinogenesis', 'combined permeability score', 'Circulating Biomarkers of Gut Barrier Function', 'permeability score']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4551463', 'cui_str': 'Colon adenoma'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0596263', 'cui_str': 'Oncogenesis'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.238965,"At baseline, a combined permeability score (the summed concentrations of all four biomarkers) was 14% lower among women (P = 0.01) and 10% higher among those who consumed >1 serving/day of red or processed meats relative to those who consumed none (Ptrend = 0.03).","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Vermandere', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Roberd M', 'Initials': 'RM', 'LastName': 'Bostick', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Hao Q', 'Initials': 'HQ', 'LastName': 'Tran', 'Affiliation': 'Center for Inflammation, Immunity, and Infection, Institute for Biomedical Sciences, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Gewirtz', 'Affiliation': 'Center for Inflammation, Immunity, and Infection, Institute for Biomedical Sciences, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Barry', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.'}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Rutherford', 'Affiliation': 'Division of Digestive Diseases, Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'March E', 'Initials': 'ME', 'LastName': 'Seabrook', 'Affiliation': 'Consultants in Gastroenterology, West Columbia, South Carolina.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Fedirko', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia. vfedirk@emory.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0461']
204,32694215,"Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial.","OBJECTIVE


The principle of replacing prandial insulin lispro with a once-weekly glucagon-like peptide 1 receptor agonist (GLP-1RA) for type 2 diabetes inadequately controlled on a multiple daily insulin injections regimen was tested with albiglutide.
RESEARCH DESIGN AND METHODS


In this treat-to-target study, basal plus prandial insulin was optimized over 4 weeks before participants were randomized (1:1) to albiglutide plus optimized basal insulin glargine and lispro (dose reduced by 50% at randomization; subsequently, lispro injections were fully discontinued 4 weeks later) ( n  = 402) or to continued optimized lispro plus optimized glargine ( n  = 412).
RESULTS


Mean ± SD HbA 1c  at baseline, 7.8 ± 0.6% (61 ± 7 mmol/mol) in the albiglutide + glargine group and 7.7 ± 0.6% (60 ± 7 mmol/mol) in the lispro + glargine group, was reduced at week 26 to 6.7 ± 0.8% (49 ± 8 mmol/mol) and 6.6 ± 0.8% (48 ± 8 mmol/mol), respectively (least squares [LS] difference 0.06% [95% CI -0.05 to 0.17]; noninferiority  P  < 0.0001). In the albiglutide + glargine group, 218 participants (54%) replaced all prandial insulin without reintroducing lispro up to week 26. Total daily prandial insulin dose was similar at baseline but was lower by 62 units/day (95% CI -65.9 to -57.8;  P  < 0.0001) at week 26 in the albiglutide + glargine group, and the total number of weekly injections was also reduced from 29 to 13 per week. Less severe/documented symptomatic hypoglycemia (57.2% vs. 75.0%) occurred in the albiglutide + glargine group with meaningful weight differences (LS mean ± SE -2.0 ± 0.2 vs. +2.4 ± 0.2 kg;  P  < 0.0001) vs. lispro + glargine. Gastrointestinal adverse events were higher with albiglutide + glargine (26% vs. 13%).
CONCLUSIONS


A once-weekly GLP-1RA was able to substitute for prandial insulin in 54% of people, substantially reducing the number of prandial insulin injections; glycemic control improved, with the added benefits of weight loss and less hypoglycemia in the GLP-1RA arm. Replacing prandial insulin with a weekly GLP-1RA can simplify basal plus prandial insulin treatments and achieve better outcomes in type 2 diabetes.",2020,"Gastrointestinal adverse events were higher with albiglutide + glargine (26% vs. 13%).
","['type 2 diabetes', 'Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy']","['lispro + glargine', 'lispro plus optimized glargine', 'albiglutide + glargine', 'albiglutide plus optimized basal insulin glargine and lispro', 'prandial insulin lispro with a once-weekly glucagon-like peptide 1 receptor agonist (GLP-1RA', 'Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide']","['number of prandial insulin injections; glycemic control', 'Total daily prandial insulin dose', 'weight loss and less hypoglycemia', 'total number of weekly injections', 'symptomatic hypoglycemia', 'Gastrointestinal adverse events', 'Mean ± SD HbA 1c']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2607479', 'cui_str': 'albiglutide'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",,0.146788,"Gastrointestinal adverse events were higher with albiglutide + glargine (26% vs. 13%).
","[{'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, TX juliorosenstock@dallasdiabetes.com.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nino', 'Affiliation': 'Research and Development Immuno-Inflammation Therapy Area Unit, GlaxoSmithKline, Collegeville, PA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Soffer', 'Affiliation': 'Research and Development Future Pipelines Discovery, GlaxoSmithKline, Collegeville, PA.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Erskine', 'Affiliation': 'Clinical Development, GlaxoSmithKline, King of Prussia, PA.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Acusta', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline, Collegeville, PA.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Dole', 'Affiliation': 'Research and Development Future Pipelines Discovery, GlaxoSmithKline, Collegeville, PA.'}, {'ForeName': 'Molly C', 'Initials': 'MC', 'LastName': 'Carr', 'Affiliation': 'Research and Development Future Pipelines Discovery, GlaxoSmithKline, Collegeville, PA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Mallory', 'Affiliation': 'Clinical Development, GlaxoSmithKline, King of Prussia, PA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Home', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, U.K.'}]",Diabetes care,['10.2337/dc19-2316']
205,33161773,Orthostatic Hypertension and Intensive Blood Pressure Control; Post-Hoc Analyses of SPRINT.,"We evaluated the association between orthostatic hypertension and cardiovascular outcomes and the effect of intensive blood pressure (BP) control on cardiovascular outcomes in patients with orthostatic hypertension. Post hoc analyses of the SPRINT (Systolic Blood Pressure Intervention Trial) data were conducted; orthostatic hypertension was defined as increase in systolic BP≥20 mm Hg or increase in diastolic BP≥10 mm Hg with standing. Of 9329 participants, 1986 (21.2%) had orthostatic hypertension at baseline. Within the intensive treatment group, participants with orthostatic hypertension were at higher risk of developing the composite cardiovascular outcome (hazard ratio, 1.44 [95% CI, 1.1-1.87],  P =0.007) compared with participants without orthostatic hypertension. Within the standard treatment group, there were no significant differences in cardiovascular outcome between participants with and without orthostatic hypertension. In participants with orthostatic hypertension, there was no statistically significant difference in risk of the composite cardiovascular outcome between the intensive and the standard BP treatment group (hazard ratio, 1.07 [95% CI, 0.78-1.47],  P =0.68). In participants without orthostatic hypertension at baseline, the intensive treatment group was associated with a lower risk of the composite cardiovascular outcome (hazard ratio, 0.67 [95% CI, 0.56-0.79],  P <0.0001). Orthostatic hypertension was associated with a higher risk of cardiovascular outcomes in the intensive and not in the standard treatment group; intensive treatment of BP did not reduce the risk of cardiovascular outcomes compared with standard treatment in patients with orthostatic hypertension. These post hoc analyses are hypothesis generating and will need to be confirmed in future studies.",2021,Orthostatic hypertension was associated with a higher risk of cardiovascular outcomes in the intensive and not in the standard treatment group; intensive treatment of BP did not reduce the risk of cardiovascular outcomes compared with standard treatment in patients with orthostatic hypertension.,"['participants with orthostatic hypertension', 'participants with and without orthostatic hypertension', 'patients with orthostatic hypertension', 'Of 9329 participants, 1986 (21.2%) had orthostatic hypertension at baseline']","['SPRINT ', 'intensive blood pressure (BP) control']","['Orthostatic hypertension', 'cardiovascular outcomes', 'orthostatic hypertension and cardiovascular outcomes', 'risk of the composite cardiovascular outcome', 'Orthostatic Hypertension and Intensive Blood Pressure Control', 'lower risk of the composite cardiovascular outcome', 'cardiovascular outcome', 'orthostatic hypertension', 'systolic BP≥20 mm Hg or increase in diastolic BP≥10 mm Hg with standing', 'risk of cardiovascular outcomes']","[{'cui': 'C0544618', 'cui_str': 'Orthostatic hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0544618', 'cui_str': 'Orthostatic hypertension'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]",9329.0,0.118852,Orthostatic hypertension was associated with a higher risk of cardiovascular outcomes in the intensive and not in the standard treatment group; intensive treatment of BP did not reduce the risk of cardiovascular outcomes compared with standard treatment in patients with orthostatic hypertension.,"[{'ForeName': 'Mahboob', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'From the Division of Nephrology and Hypertension (M.R., N.P., R.K., J.T.W.).'}, {'ForeName': 'Nishigandha', 'Initials': 'N', 'LastName': 'Pradhan', 'Affiliation': 'From the Division of Nephrology and Hypertension (M.R., N.P., R.K., J.T.W.).'}, {'ForeName': 'Zhengyi', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology (Z.C., C.T.).'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Kanthety', 'Affiliation': 'From the Division of Nephrology and Hypertension (M.R., N.P., R.K., J.T.W.).'}, {'ForeName': 'Raymond R', 'Initials': 'RR', 'LastName': 'Townsend', 'Affiliation': 'University Hospitals Cleveland Medical Center, Case Western Reserve University, OH and University of Pennsylvania Perelman School of Medicine, Philadelphia (R.R.T.).'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Tatsuoka', 'Affiliation': 'Department of Neurology (Z.C., C.T.).'}, {'ForeName': 'Jackson T', 'Initials': 'JT', 'LastName': 'Wright', 'Affiliation': 'From the Division of Nephrology and Hypertension (M.R., N.P., R.K., J.T.W.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15887']
206,33175980,A Closer Look at Yoga Nidra: Sleep Lab Protocol.,"Extended sleep onset latency (SOL), or ""sleep onset insomnia,"" can decrease total sleep time, increasing risk for many health conditions, including heart disease, stroke, and all-cause mortality. Sleep disorders persist in the United States despite current behavioral/pharmaceutical remedies, with 10% to 15% of the population suffering from insomnia. Mind-body therapies offer additional solutions, as meditation has been correlated with decreased SOL. More research on use of mind-body practices for insomnia is needed. This study investigates the guided meditation practice of Yoga Nidra (yogic sleep) as a promising intervention for sleep disorders because of its purported ability to induce mental, physical, and emotional relaxation. In this pilot study, we address the feasibility of Yoga Nidra for insomnia, appropriateness of our selected measurement systems, and effect of Yoga Nidra on brainwaves, sleep onset, and the autonomic nervous system. Our study sample includes 22 adults, ages 18-45, with insomnia. The design includes two clinic visits (V1, lying quietly for 90 min; V2, randomization to 90-min lying quietly vs. 30-min Yoga Nidra plus 60-min lying quietly), taking place 1 to 14 days apart. Outcomes measured during/after Yoga Nidra (vs. control) include sleep onset, electroencephalography (EEG) power, heart rate variability (HRV), and respiratory rate. Self-reported mood and anxiety will be measured before/after each visit. Resulting physiological, psychological, and feasibility data will be used to inform future clinical studies of Yoga Nidra for sleep and relaxation.",2021,"Extended sleep onset latency (SOL), or ""sleep onset insomnia,"" can decrease total sleep time, increasing risk for many health conditions, including heart disease, stroke, and all-cause mortality.","['22 adults, ages 18-45, with insomnia']",['guided meditation practice of Yoga Nidra (yogic sleep'],"['Extended sleep onset latency (SOL), or ""sleep onset insomnia,"" can decrease total sleep time, increasing risk for many health conditions, including heart disease, stroke, and all-cause mortality', 'sleep onset, electroencephalography (EEG) power, heart rate variability (HRV), and respiratory rate', 'Sleep disorders']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}]",,0.0400923,"Extended sleep onset latency (SOL), or ""sleep onset insomnia,"" can decrease total sleep time, increasing risk for many health conditions, including heart disease, stroke, and all-cause mortality.","[{'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Sharpe', 'Affiliation': 'National University of Natural Medicine, Portland, Ore.; and State University of New York at Canton, Canton, N.Y.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Lacombe', 'Affiliation': 'National University of Natural Medicine, Portland, Ore.; and U.S. Department of Agriculture, Produce Microbiology Research Unit, Berkley, Calif.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Butler', 'Affiliation': 'Oregon Health & Science University, Portland, Ore.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hanes', 'Affiliation': 'National University of Natural Medicine, Portland, Ore.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Bradley', 'Affiliation': 'National University of Natural Medicine, Portland, Ore.; University of California, San Diego, La Jolla, Calif.; and Australian Research Centre in Complementary and Integrative Medicine, Faculty of Health, University of Technology Sydney, Ultimo, NSW, Australia.'}]",International journal of yoga therapy,['10.17761/2021-D-20-00004']
207,32747497,B-type natriuretic peptide and cardiac remodelling after myocardial infarction: a randomised trial.,"OBJECTIVE


B-type natriuretic peptide (BNP) has favourable effects on left ventricular remodelling, including antifibrotic and antiapoptotic properties. We tested the hypothesis that infusion of BNP after an acute myocardial infarction would reduce left ventricular systolic and diastolic volumes and improve left ventricular ejection fraction compared with placebo.
METHODS


A total of 58 patients who underwent successful revascularisation for an acute ST elevation anterior myocardial infarction were randomised to receive 72-hour infusion of BNP at 0.006 µg/kg/min or placebo. Left ventricular end diastolic and systolic volumes and left ventricular ejection fraction were measured at baseline and at 30 days by multigated acquisition scan. Left ventricular infarction size was measured by cardiac MRI.
RESULTS


BNP infusion led to significantly higher BNP levels and plasma cyclic guanosine monophosphate at 72 hours. No significant difference in change of left ventricular volumes or ejection fraction from baseline to 30 days was observed between groups. Although left ventricular infarction size measured by cardiac MRI was not significantly different between BNP infusion versus placebo (p=0.39), there was a trend towards reduced infarction size in patients with a baseline ejection fraction of <40% (p=0.14).
CONCLUSIONS


Infusion of BNP in patients with an anterior myocardial infarction did not affect parameters of left ventricular remodelling. Patients treated with BNP who had a baseline left ventricular ejection fraction of <40% had a trend towards reduced left ventricular infarction size compared with placebo. These results do not support the use of intravenous BNP in patients after recent myocardial infarction.
TRIAL REGISTRATION NUMBER


NCT00573144.",2021,"RESULTS


BNP infusion led to significantly higher BNP levels and plasma cyclic guanosine monophosphate at 72 hours.","['myocardial infarction', 'patients with an anterior myocardial infarction', '58 patients who underwent successful revascularisation for an acute ST elevation anterior myocardial infarction']","['BNP infusion versus placebo', 'intravenous BNP', 'BNP', 'placebo']","['BNP levels and plasma cyclic guanosine monophosphate', 'baseline left ventricular ejection fraction', 'infarction size', 'Left ventricular infarction size', 'left ventricular infarction size', 'left ventricular infarction size measured by cardiac MRI', 'change of left ventricular volumes or ejection fraction', 'left ventricular systolic and diastolic volumes and improve left ventricular ejection fraction', 'Left ventricular end diastolic and systolic volumes and left ventricular ejection fraction']","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340293', 'cui_str': 'Myocardial Infarction, Anterior Wall'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}]","[{'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0018338', 'cui_str': 'Cyclic guanosine monophosphate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0412692', 'cui_str': 'Cardiac MRI'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444930', 'cui_str': 'End'}]",58.0,0.461985,"RESULTS


BNP infusion led to significantly higher BNP levels and plasma cyclic guanosine monophosphate at 72 hours.","[{'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Hubers', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA hubers.scott@mayo.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Schirger', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'S Jeson', 'Initials': 'SJ', 'LastName': 'Sangaralingham', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Burnett', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hodge', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Horng H', 'Initials': 'HH', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2020-317182']
208,32706640,"Comprehensive Genomic Analysis in NRG Oncology/RTOG 9802: A Phase III Trial of Radiation Versus Radiation Plus Procarbazine, Lomustine (CCNU), and Vincristine in High-Risk Low-Grade Glioma.","PURPOSE


NRG Oncology/RTOG 9802 (ClinicalTrials.gov Identifier: NCT00003375) is a practice-changing study for patients with WHO low-grade glioma (LGG, grade II), as it was the first to demonstrate a survival benefit of adjuvant chemoradiotherapy over radiotherapy. This post hoc study sought to determine the prognostic and predictive impact of the WHO-defined molecular subgroups and corresponding molecular alterations within NRG Oncology/RTOG 9802.
METHODS


IDH1/2  mutations were determined by immunohistochemistry and/or deep sequencing. A custom Ion AmpliSeq panel was used for mutation analysis. 1p/19q codeletion and  MGMT  promoter methylation were determined by copy-number arrays and/or Illumina 450K array, respectively. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Hazard ratios (HRs) were calculated using the Cox proportional hazard model and tested using the log-rank test. Multivariable analyses (MVAs) were performed incorporating treatment and common prognostic factors as covariates.
RESULTS


Of the eligible patients successfully profiled for the WHO-defined molecular groups (n = 106/251), 26 (24%) were  IDH- wild type, 43 (41%) were  IDH- mutant/non-codeleted, and 37(35%) were  IDH- mutant/codeleted. MVAs demonstrated that WHO subgroup was a significant predictor of PFS after adjustment for clinical variables and treatment. Notably, treatment with postradiation chemotherapy (PCV; procarbazine, lomustine (CCNU), and vincristine) was associated with longer PFS (HR, 0.32;  P  = .003; HR, 0.13;  P  < .001) and OS (HR, 0.38;  P  = .013; HR, 0.21;  P  = .029) in the  IDH- mutant/non-codeleted and  IDH- mutant/codeleted subgroups, respectively. In contrast, no significant difference in either PFS or OS was observed with the addition of PCV in the  IDH- wild-type subgroup.
CONCLUSION


This study is the first to report the predictive value of the WHO-defined diagnostic classification in a set of uniformly treated patients with LGG in a clinical trial. Importantly, this post hoc analysis supports the notion that patients with  IDH -mutant high-risk LGG regardless of codeletion status receive benefit from the addition of PCV.",2020,"In contrast, no significant difference in either PFS or OS was observed with the addition of PCV in the  IDH- wild-type subgroup.
","['patients with WHO low-grade glioma (LGG, grade II', 'NRG Oncology/RTOG 9802', 'High-Risk Low-Grade Glioma']","['NRG', 'Radiation Versus Radiation Plus Procarbazine, Lomustine (CCNU), and Vincristine', 'postradiation chemotherapy (PCV; procarbazine, lomustine (CCNU), and vincristine', 'adjuvant chemoradiotherapy over radiotherapy']","['PFS', 'PFS or OS', 'Progression-free survival (PFS) and overall survival (OS', 'Hazard ratios (HRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1997217', 'cui_str': 'Low grade glioma'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C3178761', 'cui_str': 'Adjuvant Chemoradiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439227', 'cui_str': 'hour'}]",,0.0972708,"In contrast, no significant difference in either PFS or OS was observed with the addition of PCV in the  IDH- wild-type subgroup.
","[{'ForeName': 'Erica H', 'Initials': 'EH', 'LastName': 'Bell', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, PA.'}, {'ForeName': 'Edward G', 'Initials': 'EG', 'LastName': 'Shaw', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Buckner', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Geoffrey R', 'Initials': 'GR', 'LastName': 'Barger', 'Affiliation': 'Wayne State University, Detroit, MI.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Bullard', 'Affiliation': 'Triangle Neurosurgery, Raleigh, NC.'}, {'ForeName': 'Minesh P', 'Initials': 'MP', 'LastName': 'Mehta', 'Affiliation': 'Baptist Hospital of Miami, Miami, FL.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Gilbert', 'Affiliation': 'National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Brown', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Stelzer', 'Affiliation': 'Mid-Columbia Medical Center, The Dalles, OR.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'McElroy', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Fleming', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Timmers', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Aline P', 'Initials': 'AP', 'LastName': 'Becker', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Salavaggione', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Aldape', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Brachman', 'Affiliation': 'Arizona Oncology Services Foundation, Phoenix, AZ.'}, {'ForeName': 'Stanley Z', 'Initials': 'SZ', 'LastName': 'Gertler', 'Affiliation': 'The Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Albert D', 'Initials': 'AD', 'LastName': 'Murtha', 'Affiliation': 'Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Schultz', 'Affiliation': 'Froedtert and the Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'Wichita NCORP, Wichita, KS.'}, {'ForeName': 'Nadia N', 'Initials': 'NN', 'LastName': 'Laack', 'Affiliation': 'Rochester Methodist Hospital, Rochester, MN.'}, {'ForeName': 'Grant K', 'Initials': 'GK', 'LastName': 'Hunter', 'Affiliation': 'Intermountain Medical Center, Murray, UT.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Crocker', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Minhee', 'Initials': 'M', 'LastName': 'Won', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, PA.'}, {'ForeName': 'Arnab', 'Initials': 'A', 'LastName': 'Chakravarti', 'Affiliation': 'The Ohio State University, Columbus, OH.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02983']
209,32713741,Adolescents' Health Perceptions of Natural American Spirit's On-the-Pack Eco-Friendly Campaign.,"PURPOSE


Natural American Spirit (NAS) cigarettes, which have recently grown in popularity, are marketed as eco-friendly and natural. The present study examined whether NAS's on-the-pack messaging influences adolescents' health perceptions of the brand.
METHODS


In a mixed-factor design, adolescent participants (N = 1,003, ages 13-17, 75% female) were randomized to one of the six exposure conditions. All viewed images of an NAS and a Pall Mall (comparison brand) cigarette pack, but differed in pack color (blue, green, or gold/orange) and brand viewed first. Perceptions of pack logos, addictiveness, harms to the smoker, others, and the environment were assessed directly after viewing pack images for each brand.
RESULTS


Adolescents who perceived NAS as more pro-environment tended to perceive NAS cigarettes to be less addictive, r = -.19, p < .01. NAS cigarettes also were perceived as less addictive and better for the environment than Pall Mall. Most (90%) participants provided nature-friendly words (e.g., environment, recycle) when asked to describe logos on the NAS packs. In adjusted models, relative to Pall Mall, NAS was perceived as healthier for smokers, healthier for smokers' family and friends, and safer for the environment. Findings did not differ by pack color and ever tobacco use.
CONCLUSIONS


Adolescents perceived a health advantage for NAS cigarettes with its on-the-pack, eco-friendly and pro-health marketing. The findings are consistent with prior research with adults. Given the accumulating evidence of consumer misperceptions, eco-friendly messaging on cigarettes is a public health concern that warrants further consideration for regulatory intervention.",2021,"RESULTS


Adolescents who perceived NAS as more pro-environment tended to perceive NAS cigarettes to be less addictive, r = -.19, p < .01.","[""adolescents' health perceptions of the brand"", 'adolescent participants (N\xa0= 1,003, ages 13-17, 75% female']",[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],,0.0237241,"RESULTS


Adolescents who perceived NAS as more pro-environment tended to perceive NAS cigarettes to be less addictive, r = -.19, p < .01.","[{'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Epperson', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Eric F', 'Initials': 'EF', 'LastName': 'Lambin', 'Affiliation': 'School of Earth, Energy & Environmental Sciences, and Woods Institute for the Environment, Stanford University, Stanford, California; Georges Lemaître Earth and Climate Research Centre, Earth and Life Institute, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Henriksen', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baiocchi', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'June A', 'Initials': 'JA', 'LastName': 'Flora', 'Affiliation': 'Solutions Science Lab, Department of Pediatrics, Stanford University, Stanford, California.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California. Electronic address: jpro@stanford.edu.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.06.033']
210,33230268,Intrinsic reward circuit connectivity profiles underlying symptom and quality of life outcomes following antidepressant medication: a report from the iSPOT-D trial.,"There is a critical need to better understand the neural basis of antidepressant medication (ADM) response with respect to both symptom alleviation and quality of life (QoL) in major depressive disorder (MDD). Reward neurocircuitry has been implicated in QoL, the neural basis of MDD, and the mechanisms of ADM response. Yet, we do not know whether change in reward neurocircuitry as a function of ADM is associated with change in symptoms and QoL. To address this gap in knowledge, we analyzed data from 128 patients with MDD who participated in the iSPOT-D trial and were assessed with functional neuroimaging pre- and post-ADM treatment (randomized to sertraline, venlafaxine-XR, or escitalopram). 58 matched healthy controls were scanned at the same time points. We quantified functional connectivity (FC) of reward neurocircuitry using nucleus accumbens (NAc) seed regions of interest, and then characterized how changes in FC relate to symptom response (primary outcome) and QoL response (secondary outcome). Symptom responders showed an increase in NAc-dorsal anterior cingulate cortex (ACC) FC relative to non-responders (p < 0.001) which was associated with improvement in physical QoL (p < 0.0003), and a decrease in NAc-inferior parietal lobule FC relative to controls (p < 0.001). QoL response was characterized by increases in FC between NAc-ventral ACC for environmental, NAc-thalamus for physical, and NAc-paracingulate gyrus for social domains (p < 0.001). Symptom responders to sertraline were distinguished by a decrease in NAc-insula FC (p < 0.001) and to venlafaxine-XR by an increase in NAc-inferior temporal gyrus FC (p < 0.005). Findings suggest that change in reward neurocircuitry may underlie differential ADM response profiles with respect to symptoms and QoL in depression.",2021,Symptom responders showed an increase in NAc-dorsal anterior cingulate cortex (ACC),"['128 patients with MDD who participated in the iSPOT-D trial and were assessed with functional neuroimaging pre- and post-ADM treatment (randomized to', '58 matched healthy controls']","['antidepressant medication', 'sertraline, venlafaxine-XR, or escitalopram']","['QoL response', 'NAc-inferior parietal lobule FC relative', 'NAc-insula FC', 'physical QoL', 'NAc-dorsal anterior cingulate cortex (ACC', 'NAc-inferior temporal gyrus FC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3178877', 'cui_str': 'Functional Neuroimaging'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0152310', 'cui_str': 'Structure of middle temporal gyrus'}]",128.0,0.0573567,Symptom responders showed an increase in NAc-dorsal anterior cingulate cortex (ACC),"[{'ForeName': 'Adina S', 'Initials': 'AS', 'LastName': 'Fischer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. adinaf@stanford.edu.'}, {'ForeName': 'Bailey', 'Initials': 'B', 'LastName': 'Holt-Gosselin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Fleming', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Hack', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Tali M', 'Initials': 'TM', 'LastName': 'Ball', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Schatzberg', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. leawilliams@stanford.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00905-3']
211,32710192,Vedolizumab Dose Escalation Improves Therapeutic Response in a Subset of Patients with Ulcerative Colitis.,"BACKGROUND


The Gemini trial failed to detect a significant difference in response rate for patients with ulcerative colitis (UC) randomized to standard (every 8 week) vedolizumab dosing vs escalated (every 4 week) dosing. Subsequent real-world data imply the Gemini trial design may have obscured a benefit of escalated dosing.
AIMS


We investigated outcomes after vedolizumab dose escalation for patients with UC. We also explored potential clinical predictors of dose escalation requirement.
METHODS


In this retrospective study, we included patients with UC who received vedolizumab between 1/2017-1/2019. We compared rates of clinical response (decrease in partial Mayo score by ≥ 2) and remission (partial Mayo < 2) for standard vs escalated dosing.
RESULTS


Among the 90 patients reviewed, 52 achieved and maintained remission on standard dosing. The average time to remission with standard dosing was 33.3 ± 6.6 weeks. After an average of 56.3 ± 7.4 weeks standard dosing, 24 patients (22 ""partial responders"" and 2 ""non-responders"") were dose-escalated. Of the 22 ""partial responders"" dose-escalated, 10 (45%) achieved remission, 10 (45%) achieved further improvement. Neither ""non-responder"" demonstrated further clinical benefit. Prior anti-tumor necrosis factor (anti-TNF) biologic exposure predicted dose escalation requirement (p = 0.008). Patients requiring dose escalation had more severe disease at baseline as measured by both full Mayo (p = 0.009) and partial Mayo scores (p = 0.01).
CONCLUSIONS


We show dose escalation benefited patients with UC who exhibit a ""partial response"" to standard dosing. Early vedolizumab dose escalation should be considered in both patients with severe disease and those with prior anti-TNF experience.",2021,"Patients requiring dose escalation had more severe disease at baseline as measured by both full Mayo (p = 0.009) and partial Mayo scores (p = 0.01).
","['patients with UC who received vedolizumab between 1/2017-1/2019', '90 patients reviewed, 52 achieved and maintained remission on standard dosing', 'patients with severe disease and those with prior anti-TNF experience', 'Patients with Ulcerative Colitis', 'patients with ulcerative colitis (UC', 'patients with UC']","['vedolizumab', 'Vedolizumab Dose Escalation']","['partial Mayo scores', 'rates of clinical response', 'severe disease', 'response rate', 'average time to remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C2742797', 'cui_str': 'vedolizumab'}, {'cui': 'C0451610', 'cui_str': 'Patient review'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C2742797', 'cui_str': 'vedolizumab'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",90.0,0.0418782,"Patients requiring dose escalation had more severe disease at baseline as measured by both full Mayo (p = 0.009) and partial Mayo scores (p = 0.01).
","[{'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Perry', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, University of Kentucky College of Medicine, 800 Rose Street, MN649, Lexington, KY, 40536, USA. clpe234@uky.edu.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department of Internal Medicine, University of Kentucky College of Medicine, Lexington, KY, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elmoursi', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, University of Kentucky College of Medicine, 800 Rose Street, MN649, Lexington, KY, 40536, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Kern', 'Affiliation': 'Department of Internal Medicine, University of Kentucky College of Medicine, Lexington, KY, USA.'}, {'ForeName': 'Alden', 'Initials': 'A', 'LastName': 'Currier', 'Affiliation': 'Department of Internal Medicine, University of Kentucky College of Medicine, Lexington, KY, USA.'}, {'ForeName': 'Praneeth', 'Initials': 'P', 'LastName': 'Kudaravalli', 'Affiliation': 'Department of Internal Medicine, University of Kentucky College of Medicine, Lexington, KY, USA.'}, {'ForeName': 'Olalekan', 'Initials': 'O', 'LastName': 'Akanbi', 'Affiliation': 'Department of Internal Medicine, University of Kentucky College of Medicine, Lexington, KY, USA.'}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Tripathi', 'Affiliation': 'Department of Internal Medicine, University of Kentucky College of Medicine, Lexington, KY, USA.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Yarra', 'Affiliation': 'Department of Internal Medicine, University of Kentucky College of Medicine, Lexington, KY, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Su', 'Affiliation': 'Dr. Bing Zhang Department of Statistics, University of Kentucky College of Arts and Sciences, Lexington, KY, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Flomenhoft', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, University of Kentucky College of Medicine, 800 Rose Street, MN649, Lexington, KY, 40536, USA.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Stromberg', 'Affiliation': 'Dr. Bing Zhang Department of Statistics, University of Kentucky College of Arts and Sciences, Lexington, KY, USA.'}, {'ForeName': 'Terrence A', 'Initials': 'TA', 'LastName': 'Barrett', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, University of Kentucky College of Medicine, 800 Rose Street, MN649, Lexington, KY, 40536, USA.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06486-x']
212,32760144,A gender-sensitised weight-loss and healthy living program for men with overweight and obesity in Australian Football League settings (Aussie-FIT): A pilot randomised controlled trial.,"BACKGROUND


Recent evidence shows that sport settings can act as a powerful draw to engage men in weight loss. The primary objective of this pilot study was to test the feasibility of delivering and to evaluate preliminary efficacy of Aussie-FIT, a weight-loss program for men with overweight/obesity delivered in Australian Football League (AFL) settings, in preparation for a future definitive trial.
METHODS AND FINDINGS


This 6-month pilot trial took place in Perth, Australia. Participants were overweight/obese (Body Mass Index [BMI] ≥ 28 kg/m2), middle-aged (35-65 years old) men. Participants were recruited in May 2018, and the intervention took place between June and December 2018. The intervention involved 12 weekly 90-min face-to-face sessions, incorporating physical activity, nutrition, and behaviour change information and practical activities delivered by coaches at 2 clubs. Data were collected at baseline and immediately postintervention. For trial feasibility purposes, 6-month follow-ups were completed. Outcomes were differences in weight loss (primary outcome) and recruitment and retention rates, self-reported measures (for example, psychological well-being), device-measured physical activity, waist size, and blood pressure at 3 months. Within 3 days of advertising at each club, 426 men registered interest; 306 (72%) were eligible. Men were selected on a first-come first-served basis (n = 130; M age = 45.8, SD = 8; M BMI = 34.48 kg/m2, SD = 4.87) and randomised by a blinded researcher. Trial retention was 86% and 63% at 3- and 6-month follow-ups (respectively). No adverse events were reported. At 3 months, mean difference in weight between groups, adjusted for baseline weight and group, was 3.3 kg (95% CI 1.9, 4.8) in favour of the intervention group (p < 0.001). The intervention group's moderate-to-vigorous physical activity (MVPA) was higher than the control group by 8.54 min/day (95% CI 1.37, 15.71, p = 0.02). MVPA among men attracted to Aussie-FIT was high at baseline (intervention arm 35.61 min/day, control arm 38.38 min/day), which may have limited the scope for improvement.
CONCLUSIONS


Aussie-FIT was feasible to deliver; participants increased physical activity, decreased weight, and reported improvements in other outcomes. Issues with retention were a limitation of this trial. In a future, fully powered randomised controlled trial (RCT), retention could be improved by conducting assessments outside of holiday seasons.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry: ACTRN12617000515392.",2020,"MVPA among men attracted to Aussie-FIT was high at baseline (intervention arm 35.61 min/day, control arm 38.38 min/day), which may have limited the scope for improvement.
","['men with overweight/obesity delivered in Australian Football League (AFL) settings', '426 men registered interest; 306 (72%) were eligible', '28 kg/m2), middle-aged (35-65 years old) men', 'men with overweight and obesity in Australian Football League settings (Aussie-FIT', 'Men were selected on a first-come first-served basis (n = 130; M age = 45.8, SD = 8; M BMI = 34.48 kg/m2, SD = 4.87', 'Participants were overweight/obese', 'Participants were recruited in May 2018, and the intervention took place between June and December 2018']","['MVPA', 'Aussie-FIT, a weight-loss program']","['weight loss (primary outcome) and recruitment and retention rates, self-reported measures (for example, psychological well-being), device-measured physical activity, waist size, and blood pressure', 'moderate-to-vigorous physical activity (MVPA', 'physical activity, decreased weight', 'adverse events']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.212539,"MVPA among men attracted to Aussie-FIT was high at baseline (intervention arm 35.61 min/day, control arm 38.38 min/day), which may have limited the scope for improvement.
","[{'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Kwasnicka', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hunt', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Australia.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Gucciardi', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Thøgersen-Ntoumani', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Olson', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'McVeigh', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Kerr', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'Priority Research Centre in Physical Activity and Nutrition, School of Education, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Makate', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Quested', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003136']
213,32762289,Synchrony in Old Age: Playing the Mirror Game Improves Cognitive Performance.,"OBJECTIVES


Studies have shown that synchronized motion between people positively affects a range of emotional and social functions. The mirror-game is a synchrony-based paradigm, common to theater, performance arts, and therapy, which includes dyadic synchronized motion, playfulness, and spontaneity. The goal of the current study is to examine the effects of the mirror-game on subjective and cognitive indices in late life.
METHODS


Thirty-four older adults (aged 71-98) participated in a within-group study design. Participants conducted two sessions of 9-minute movement activities: the mirror-game and the control condition - a physical exercise class. Several measures were taken before and after experimental sessions to assess socio-emotional and attentional functions.
RESULTS


The mirror-game enhanced performance on the attention sub-scale and led to faster detections of spoken words in noise. Further, it enhanced perceived partner responsiveness and led to an increase in positive reported experience.
CONCLUSIONS


Our preliminary findings suggest that the mirror-game, rather than the exercise class, may have an immediate impact on mood and some attentional functions.
CLINICAL IMPLICATIONS


The mirror-game is a novel intervention, with potential benefits of social-emotional and cognitive functioning, which can be easily implemented into the daily routine care of older adults. Future studies should explore the effect of the mirror-game on additional cognitive and socio-emotional aspects.",2022,Participants conducted two sessions of 9-minute movement activities: the mirror-game and the control condition - a physical exercise class.,"['Old Age', 'Thirty-four older adults (aged 71-98) participated in a within-group study design', 'older adults']",['9-minute movement activities: the mirror-game and the control condition - a physical exercise class'],"['socio-emotional and attentional functions', 'Cognitive Performance']","[{'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C2004436', 'cui_str': 'Activity therapy'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",34.0,0.0252285,Participants conducted two sessions of 9-minute movement activities: the mirror-game and the control condition - a physical exercise class.,"[{'ForeName': 'Shoshi', 'Initials': 'S', 'LastName': 'Keisari', 'Affiliation': 'Department of Gerontology, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Rinat', 'Initials': 'R', 'LastName': 'Feniger-Schaal', 'Affiliation': 'School of Creative Arts Therapies, The Center for the Study of Child Development, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Palgi', 'Affiliation': 'Department of Gerontology, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Golland', 'Affiliation': 'Sagol Center for Brain and Mind, Baruch Ivcher School of Psychology, Interdisciplinary Center (IDC) Herzliya, Herzliya, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Gesser-Edelsburg', 'Affiliation': 'School of Public Health and the Health and Risk Communication Research Center, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Ben-David', 'Affiliation': 'Baruch Ivcher School of Psychology, The Interdisciplinary Center (IDC) Herzliya, Herzliya, Israel.'}]",Clinical gerontologist,['10.1080/07317115.2020.1799131']
214,33095526,Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries.,"BACKGROUND


The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain.
METHODS


We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale.
RESULTS


A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P = 0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events.
CONCLUSIONS


Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection. (Funded by the Bill and Melinda Gates Foundation and the World Health Organization; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000476336; Clinical Trials Registry-India number, CTRI/2017/04/008326.).",2020,"Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03).","['pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth', 'women in low-resource countries who were at risk for early preterm birth', 'women in low-resource countries who are at risk for preterm birth', 'Early Preterm Birth in Low-Resource Countries', '2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization']","['Antenatal Dexamethasone', 'dexamethasone or identical placebo', 'dexamethasone', 'placebo', 'antenatal glucocorticoids']","['neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection', 'Neonatal death', 'risks of neonatal death alone and stillbirth or neonatal death', 'incidence of possible maternal bacterial infection', 'Stillbirth or neonatal death', 'incidence of adverse events']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2852.0,0.544249,"Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Olufemi T', 'Initials': 'OT', 'LastName': 'Oladapo', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Vogel', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Gilda', 'Initials': 'G', 'LastName': 'Piaggio', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'My-Huong', 'Initials': 'MH', 'LastName': 'Nguyen', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Althabe', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'A Metin', 'Initials': 'AM', 'LastName': 'Gülmezoglu', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Suman P N', 'Initials': 'SPN', 'LastName': 'Rao', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'De Costa', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shuchita', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Abdullah H', 'Initials': 'AH', 'LastName': 'Baqui', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Rasheda', 'Initials': 'R', 'LastName': 'Khanam', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Mohammod', 'Initials': 'M', 'LastName': 'Shahidullah', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Saleha B', 'Initials': 'SB', 'LastName': 'Chowdhury', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Salahuddin', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Nazma', 'Initials': 'N', 'LastName': 'Begum', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Arunangshu', 'Initials': 'A', 'LastName': 'D Roy', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Shahed', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Iffat A', 'Initials': 'IA', 'LastName': 'Jaben', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Farida', 'Initials': 'F', 'LastName': 'Yasmin', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'M Mozibur', 'Initials': 'MM', 'LastName': 'Rahman', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Anjuman', 'Initials': 'A', 'LastName': 'Ara', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Soofia', 'Initials': 'S', 'LastName': 'Khatoon', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Gulshan', 'Initials': 'G', 'LastName': 'Ara', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shaheen', 'Initials': 'S', 'LastName': 'Akter', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Nasreen', 'Initials': 'N', 'LastName': 'Akhter', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Probhat R', 'Initials': 'PR', 'LastName': 'Dey', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'M Abdus', 'Initials': 'MA', 'LastName': 'Sabur', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Mohammad T', 'Initials': 'MT', 'LastName': 'Azad', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shahana F', 'Initials': 'SF', 'LastName': 'Choudhury', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Matin', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sangappa M', 'Initials': 'SM', 'LastName': 'Dhaded', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Mrityunjay C', 'Initials': 'MC', 'LastName': 'Metgud', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Yeshita V', 'Initials': 'YV', 'LastName': 'Pujar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Manjunath S', 'Initials': 'MS', 'LastName': 'Somannavar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Vernekar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Veena R', 'Initials': 'VR', 'LastName': 'Herekar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shailaja R', 'Initials': 'SR', 'LastName': 'Bidri', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sangamesh S', 'Initials': 'SS', 'LastName': 'Mathapati', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Preeti G', 'Initials': 'PG', 'LastName': 'Patil', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Mallanagouda M', 'Initials': 'MM', 'LastName': 'Patil', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Muttappa R', 'Initials': 'MR', 'LastName': 'Gudadinni', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Hidaytullah R', 'Initials': 'HR', 'LastName': 'Bijapure', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Geetanjali M', 'Initials': 'GM', 'LastName': 'Katageri', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sumangala B', 'Initials': 'SB', 'LastName': 'Chikkamath', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Bhuvaneshwari C', 'Initials': 'BC', 'LastName': 'Yelamali', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ramesh R', 'Initials': 'RR', 'LastName': 'Pol', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sujata S', 'Initials': 'SS', 'LastName': 'Misra', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Das', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Nanda', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Rashmita B', 'Initials': 'RB', 'LastName': 'Nayak', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Bipsa', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Zahida', 'Initials': 'Z', 'LastName': 'Qureshi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Were', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Osoti', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Gwako', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Laving', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Hafsa', 'Initials': 'H', 'LastName': 'Mohamed', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Nawal', 'Initials': 'N', 'LastName': 'Aliyan', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adelaide', 'Initials': 'A', 'LastName': 'Barassa', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kibaru', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Mbuga', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Thuranira', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Njoroge J', 'Initials': 'NJ', 'LastName': 'Githua', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Bernadine', 'Initials': 'B', 'LastName': 'Lusweti', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adejumoke I', 'Initials': 'AI', 'LastName': 'Ayede', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adegoke G', 'Initials': 'AG', 'LastName': 'Falade', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olubukola A', 'Initials': 'OA', 'LastName': 'Adesina', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Atinuke M', 'Initials': 'AM', 'LastName': 'Agunloye', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Oluwatosin O', 'Initials': 'OO', 'LastName': 'Iyiola', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Wilfred', 'Initials': 'W', 'LastName': 'Sanni', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ifeyinwa K', 'Initials': 'IK', 'LastName': 'Ejinkeonye', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Hadiza A', 'Initials': 'HA', 'LastName': 'Idris', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Chinyere V', 'Initials': 'CV', 'LastName': 'Okoli', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Irinyenikan', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Omolayo A', 'Initials': 'OA', 'LastName': 'Olubosede', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olaseinde', 'Initials': 'O', 'LastName': 'Bello', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olufemi M', 'Initials': 'OM', 'LastName': 'Omololu', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olanike A', 'Initials': 'OA', 'LastName': 'Olutekunbi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adesina L', 'Initials': 'AL', 'LastName': 'Akintan', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olorunfemi O', 'Initials': 'OO', 'LastName': 'Owa', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Rosena O', 'Initials': 'RO', 'LastName': 'Oluwafemi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ireti P', 'Initials': 'IP', 'LastName': 'Eniowo', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adetokunbo O', 'Initials': 'AO', 'LastName': 'Fabamwo', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Disu', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Joy O', 'Initials': 'JO', 'LastName': 'Agbara', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ebunoluwa A', 'Initials': 'EA', 'LastName': 'Adejuyigbe', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Oluwafemi', 'Initials': 'O', 'LastName': 'Kuti', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Henry C', 'Initials': 'HC', 'LastName': 'Anyabolu', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ibraheem O', 'Initials': 'IO', 'LastName': 'Awowole', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Akintunde O', 'Initials': 'AO', 'LastName': 'Fehintola', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Bankole P', 'Initials': 'BP', 'LastName': 'Kuti', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Isah', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Eyinade K', 'Initials': 'EK', 'LastName': 'Olateju', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olusanya', 'Initials': 'O', 'LastName': 'Abiodun', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olabisi F', 'Initials': 'OF', 'LastName': 'Dedeke', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Francis B', 'Initials': 'FB', 'LastName': 'Akinkunmi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Lawal', 'Initials': 'L', 'LastName': 'Oyeneyin', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Omotayo', 'Initials': 'O', 'LastName': 'Adesiyun', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Hadijat O', 'Initials': 'HO', 'LastName': 'Raji', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adedapo B A', 'Initials': 'ABA', 'LastName': 'Ande', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ikechukwu', 'Initials': 'I', 'LastName': 'Okonkwo', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shabina', 'Initials': 'S', 'LastName': 'Ariff', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sajid B', 'Initials': 'SB', 'LastName': 'Soofi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Lumaan', 'Initials': 'L', 'LastName': 'Sheikh', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Zulfiqar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Omer', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Raheel', 'Initials': 'R', 'LastName': 'Sikandar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Giordano', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Gamerro', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Carroli', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Carvalho', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Neilson', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Molyneux', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Yunis', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Kidza', 'Initials': 'K', 'LastName': 'Mugerwa', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Harish K', 'Initials': 'HK', 'LastName': 'Chellani', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}]",The New England journal of medicine,['10.1056/NEJMoa2022398']
215,32780794,A randomized crossover trial on the effect of plant-based compared with animal-based meat on trimethylamine-N-oxide and cardiovascular disease risk factors in generally healthy adults: Study With Appetizing Plantfood-Meat Eating Alternative Trial (SWAP-MEAT).,"BACKGROUND


Despite the rising popularity of plant-based alternative meats, there is limited evidence of the health effects of these products.
OBJECTIVES


We aimed to compare the effect of consuming plant-based alternative meat (Plant) as opposed to animal meat (Animal) on health factors. The primary outcome was fasting serum trimethylamine-N-oxide (TMAO). Secondary outcomes included fasting insulin-like growth factor 1, lipids, glucose, insulin, blood pressure, and weight.
METHODS


SWAP-MEAT (The Study With Appetizing Plantfood-Meat Eating Alternatives Trial) was a single-site, randomized crossover trial with no washout period. Participants received Plant and Animal products, dietary counseling, lab assessments, microbiome assessments (16S), and anthropometric measurements. Participants were instructed to consume ≥2 servings/d of Plant compared with Animal for 8 wk each, while keeping all other foods and beverages as similar as possible between the 2 phases.
RESULTS


The 36 participants who provided complete data for both crossover phases included 67% women, were 69% Caucasian, had a mean ± SD age 50 ± 14 y, and BMI 28 ± 5 kg/m2. Mean ± SD servings per day were not different by intervention sequence: 2.5 ± 0.6 compared with 2.6 ± 0.7 for Plant and Animal, respectively (P = 0.76). Mean ± SEM TMAO concentrations were significantly lower overall for Plant (2.7 ± 0.3) than for Animal (4.7 ± 0.9) (P = 0.012), but a significant order effect was observed (P = 0.023). TMAO concentrations were significantly lower for Plant among the n = 18 who received Plant second (2.9 ± 0.4 compared with 6.4 ± 1.5, Plant compared with Animal, P = 0.007), but not for the n = 18 who received Plant first (2.5 ± 0.4 compared with 3.0 ± 0.6, Plant compared with Animal, P = 0.23). Exploratory analyses of the microbiome failed to reveal possible responder compared with nonresponder factors. Mean ± SEM LDL-cholesterol concentrations (109.9 ± 4.5 compared with 120.7 ± 4.5 mg/dL, P = 0.002) and weight (78.7 ± 3.0 compared with 79.6 ± 3.0 kg, P < 0.001) were lower during the Plant phase.
CONCLUSIONS


Among generally healthy adults, contrasting Plant with Animal intake, while keeping all other dietary components similar, the Plant products improved several cardiovascular disease risk factors, including TMAO; there were no adverse effects on risk factors from the Plant products.This trial was registered at clinicaltrials.gov as NCT03718988.",2020,"Mean ± SEM TMAO concentrations were significantly lower overall for Plant (2.7 ± 0.3) than for Animal (4.7 ± 0.9) (P = 0.012), but a significant order effect was observed (P = 0.023).","['36 participants who provided complete data for both crossover phases included 67% women, were 69% Caucasian, had a mean\xa0±\xa0SD age 50\xa0±', 'generally healthy adults']","['consuming plant-based alternative meat (Plant', 'Plant and Animal products, dietary counseling, lab assessments, microbiome assessments (16S), and anthropometric measurements', 'SWAP-MEAT ', 'plant-based compared with animal-based meat on trimethylamine-N-oxide']","['fasting insulin-like growth factor 1, lipids, glucose, insulin, blood pressure, and weight', 'Mean\xa0±', 'weight', 'Mean\xa0±\xa0SEM LDL-cholesterol concentrations', 'TMAO concentrations', 'fasting serum trimethylamine-N-oxide (TMAO', 'Mean\xa0±\xa0SEM TMAO concentrations']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0025018', 'cui_str': 'Meat products'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.0987864,"Mean ± SEM TMAO concentrations were significantly lower overall for Plant (2.7 ± 0.3) than for Animal (4.7 ± 0.9) (P = 0.012), but a significant order effect was observed (P = 0.023).","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Crimarco', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Sparkle', 'Initials': 'S', 'LastName': 'Springfield', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Petlura', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Streaty', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Cunanan', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Fielding-Singh', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Carter', 'Affiliation': 'Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Madeline A', 'Initials': 'MA', 'LastName': 'Topf', 'Affiliation': 'Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Hannah C', 'Initials': 'HC', 'LastName': 'Wastyk', 'Affiliation': 'Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Sonnenburg', 'Affiliation': 'Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Sonnenburg', 'Affiliation': 'Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa203']
216,32772853,Benefits of a support programme for family caregivers of patients at the end of life: A randomised controlled trial.,"This study aims to analyse the impact that a psychological intervention programme has on the emotional state of family caregivers of patients at the end of life. The study is longitudinal with two arms (control and experimental). Data was collected from 154 primary family caregivers of patients at the end of life as well as from their respective 154 care-recipients. The intervention programme has shown its effectiveness in reducing anxiety, emotional distress and burden in the family caregivers of end-of-life patients. A reduction of anxiety of patients whose family caregivers participated in the intervention was also observed.",2022,"The intervention programme has shown its effectiveness in reducing anxiety, emotional distress and burden in the family caregivers of end-of-life patients.","['154 primary family caregivers of patients at the end of life as well as from their respective 154 care-recipients', 'family caregivers of patients at the end of life']",['psychological intervention programme'],[],"[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],154.0,0.0261455,"The intervention programme has shown its effectiveness in reducing anxiety, emotional distress and burden in the family caregivers of end-of-life patients.","[{'ForeName': 'Ana Lucila', 'Initials': 'AL', 'LastName': 'Soto-Rubio', 'Affiliation': 'University of Valencia, Spain.'}, {'ForeName': 'Selene', 'Initials': 'S', 'LastName': 'Valero-Moreno', 'Affiliation': 'University of Valencia, Spain.'}, {'ForeName': 'Marián', 'Initials': 'M', 'LastName': 'Pérez-Marín', 'Affiliation': 'University of Valencia, Spain.'}]",Journal of health psychology,['10.1177/1359105320944993']
217,32772857,A randomized trial of a brief behavioral health lifestyle program for outpatient cardiology clinics.,"Research on lifestyle programs for patients with coronary artery disease (CAD) has largely recruited from hospitals and/or recruited following acute coronary syndrome. By contrast, this study evaluated a 3-session behavioral health program for patients with stable CAD treated in an outpatient cardiology clinic. Thirty-three patients were randomized to the behavioral lifestyle intervention or to Treatment as Usual (TAU). A priori feasibility and acceptability criteria were met, and reliable change analyses revealed that at post-treatment and 30-day follow-up, significantly more intervention participants than TAU participants exhibited increased self-efficacy compared with baseline.",2022,"A priori feasibility and acceptability criteria were met, and reliable change analyses revealed that at post-treatment and 30-day follow-up, significantly more intervention participants than TAU participants exhibited increased self-efficacy compared with baseline.","['Thirty-three patients', 'outpatient cardiology clinics', 'patients with stable CAD treated in an outpatient cardiology clinic', 'patients with coronary artery disease (CAD']","['behavioral lifestyle intervention or to Treatment as Usual (TAU', 'behavioral health lifestyle program']",['self-efficacy'],"[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3810847', 'cui_str': 'Cardiology clinic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",33.0,0.0270214,"A priori feasibility and acceptability criteria were met, and reliable change analyses revealed that at post-treatment and 30-day follow-up, significantly more intervention participants than TAU participants exhibited increased self-efficacy compared with baseline.","[{'ForeName': 'Chelsea H', 'Initials': 'CH', 'LastName': 'Wiener', 'Affiliation': 'University of Central Florida, USA.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Cassisi', 'Affiliation': 'University of Central Florida, USA.'}, {'ForeName': 'Cerissa L', 'Initials': 'CL', 'LastName': 'Blaney', 'Affiliation': 'University of Central Florida, USA.'}, {'ForeName': 'Amie R', 'Initials': 'AR', 'LastName': 'Newins', 'Affiliation': 'University of Central Florida, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Gros', 'Affiliation': 'University of Central Florida, USA.'}]",Journal of health psychology,['10.1177/1359105320945003']
218,32799781,Older Adults' Responses to a Meaningful Activity Using Indoor-Based Nature Experiences: Bird Tales.,"OBJECTIVES


Bird Tales is a meaningful activity that creates indoor-based nature experiences for older adults in residential care. This study examined the impact of Bird Tales by understanding what attributes of birds take on meaning to older adults and piloting the program to assess the psychosocial impact on older adults in an assisted living facility.
METHODS


We conducted a mixed-methods study. First, we conducted focus groups with older adults. Then we used a cross-over study design with random assignment to examine the impact of the program. Potential benefits of the program were examined using individual interviews and repeated measures on psychosocial questionnaires with a paired samples t-test to compare means from pretest and posttest within the intervention group.
RESULTS


Findings from the focus group indicate multisensory, spiritual, and therapeutic aspects of birds that hold meaning for older adults. The participants in Bird Tales shared positive experiences with the program by discussing cognitively stimulating activity, interactions with others, connections to the past, and positive perceptions of birds and nature.
CONCLUSIONS


Findings from our study suggest the potential of Bird Tales as a meaningful activity for older adults in residential care settings. We discuss implications for research as well as practice and present our recommendations.
CLINICAL IMPLICATIONS


Activities in long-term care should be meaningful to meet the psychological and social needs of older adults. Older adults enjoy and may benefit from indoor-based nature activities.",2022,"The participants in Bird Tales shared positive experiences with the program by discussing cognitively stimulating activity, interactions with others, connections to the past, and positive perceptions of birds and nature.
","['groups with older adults', 'older adults in residential care settings', 'older adults in residential care', 'Older adults', 'older adults in an assisted living facility']",[],"['multisensory, spiritual, and therapeutic aspects of birds that hold meaning']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]",[],"[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005595', 'cui_str': 'Class Aves'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}]",,0.0159739,"The participants in Bird Tales shared positive experiences with the program by discussing cognitively stimulating activity, interactions with others, connections to the past, and positive perceptions of birds and nature.
","[{'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'School of Social Work, University of Texas at Arlington.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cassidy', 'Affiliation': 'School of Social Work, University of Texas at Arlington.'}, {'ForeName': 'Weizhou', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Leonard Davis School of Gerontology, University of Southern California.'}, {'ForeName': 'Venieca', 'Initials': 'V', 'LastName': 'Kusek', 'Affiliation': 'School of Social Work, University of Texas at Arlington.'}]",Clinical gerontologist,['10.1080/07317115.2020.1808869']
219,32812046,A qualitative account of young people's experiences of alcohol screening and brief interventions in schools: SIPS Jr-HIGH trial findings.,"BACKGROUND


The United Kingdom (UK) has seen a decrease in the number of young people drinking alcohol. However, the UK prevalence of underage drinking still ranks amongst the highest in Western Europe. Whilst there is a wealth of evidence reporting on the effectiveness of both primary, and secondary interventions, there are few reports of the experiences of young people who receive them.
METHODS


The present study reports findings from interviews with 33 young people who were involved in an alcohol screening and brief intervention randomized controlled trial in schools in England. All interviews were analysed using inductive applied thematic analysis.
RESULTS


Three major themes were identified following the analysis process: 1) drinking identities and awareness of risk; 2) access to support and advice in relation to alcohol use; and 3) appraisal of the intervention and potential impact on alcohol use.
CONCLUSIONS


There appeared to be a reluctance from participants to describe themselves as someone who drinks alcohol. Furthermore, those who did drink alcohol often did so with parental permission. There was variation amongst participants as to how comfortable they felt talking about alcohol issues with school staff. Overall participants felt the intervention was useful, but would be better suited to 'heavier' drinkers.",2020,There was variation amongst participants as to how comfortable they felt talking about alcohol issues with school staff.,"['33 young people who were involved in an alcohol screening and brief intervention randomized controlled trial in schools in England', ""young people's experiences of alcohol screening and brief interventions in schools""]",[],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",[],[],33.0,0.0264986,There was variation amongst participants as to how comfortable they felt talking about alcohol issues with school staff.,"[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Giles', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'McGeechan', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Scott', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'McGovern', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, NE2 4AX, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boniface', 'Affiliation': ""Institute of Psychiatry, Psychology, & Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ramsay', 'Affiliation': ""Institute of Psychiatry, Psychology, & Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hendrie', 'Affiliation': 'Centre for Health Services Research, University of Kent, Canterbury, Kent, CT2 7NF, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, NE2 4AX, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sumnall', 'Affiliation': 'Faculty of Education, Health and Community, Liverpool John Moores University, Liverpool, L3 2 ET, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Newbury-Birch', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, NE2 4AX, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdz074']
220,32910352,A Multidimensional Model of Sexual Empowerment Among Young Black Men Who have Sex with Men: A Latent Profile Analysis.,"Sexual empowerment is a key strategy in HIV prevention intervention design, yet its measurement has been conceptualized as homogeneous. To date, no studies have examined whether young Black men who have sex with men (YBMSM) exhibit heterogeneity across sexual empowerment. Using baseline data from a randomized controlled trial (N = 275, HIV-negative YBMSM), we classified YBMSM into sexual empowerment profiles based on five indicators using a latent profile analysis and assessed the associations between the sexual empowerment profiles and stigma-related experiences using multinomial logistic regression. Three profiles were identified: psychologically empowered with safer sex intentions (profile 1); psychologically disempowered with safer sex intentions (profile 2); and psychologically disempowered without safer sex intentions (profile 3). YBMSM reporting fewer stigma-related experiences were more likely to be profile 1 than profile 2 and profile 3. To empower YBMSM, interventions based on sexual empowerment profile targeting the psychological/behavioral aspects of empowerment and addressing stigma are needed.",2021,Three profiles were identified: psychologically empowered with safer sex intentions (profile 1); psychologically disempowered with safer sex intentions (profile 2); and psychologically disempowered without safer sex intentions (profile 3).,"['Who have Sex with Men', 'young Black men who have sex with men (YBMSM', 'Young Black Men']",['YBMSM'],[],"[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]",[],3.0,0.028098,Three profiles were identified: psychologically empowered with safer sex intentions (profile 1); psychologically disempowered with safer sex intentions (profile 2); and psychologically disempowered without safer sex intentions (profile 3).,"[{'ForeName': 'Seul Ki', 'Initials': 'SK', 'LastName': 'Choi', 'Affiliation': 'Department of Family and Community Health, School of Nursing, University of Pennsylvania, 418 Curie Blvd, Room 235L, Philadelphia, PA, 19104, USA. skchoi@nursing.upenn.edu.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Bauermeister', 'Affiliation': 'Department of Family and Community Health, School of Nursing, University of Pennsylvania, 418 Curie Blvd, Room 235L, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Muessig', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ennett', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Marcella H', 'Initials': 'MH', 'LastName': 'Boynton', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hightow-Weidman', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03031-9']
221,32829666,Effects of Intensive Versus Standard Office-Based Hypertension Treatment Strategy on White-Coat Effect and Masked Uncontrolled Hypertension: From the SPRINT ABPM Ancillary Study.,"Guidelines recommend using out-of-office blood pressure (BP) measurements to confirm the diagnoses of hypertension and in the titration of antihypertensive medication. The prevalence of out-of-office BP phenotypes for an office systolic/diastolic BP goal <140/90 mm Hg has been reported. However, the prevalence of these phenotypes when targeting an office systolic/diastolic BP goal <120/80 is unknown. The SPRINT (Systolic Blood Pressure Intervention Trial) Ambulatory BP Ancillary study evaluated out-of-office BP using ambulatory BP monitoring in 897 participants 27 months after randomization to intensive versus standard BP targets (office systolic BP <120 versus <140 mm Hg). We used office and daytime BP to assess the proportion of participants with white-coat effect (standard target: office BP ≥140/90 mm Hg and daytime BP <135/85 mm Hg versus intensive target: office BP ≥120/80 mm Hg and daytime BP <120/80 mm Hg) and masked uncontrolled hypertension (standard target: office BP <140/90 mm Hg and daytime BP ≥135/85 mm Hg versus intensive target: office BP <120/80 mm Hg and daytime BP ≥120/80 mm Hg) in each treatment arm. The prevalence of white-coat effect and masked uncontrolled hypertension was 9% and 34%, in both treatment groups. Among participants with uncontrolled office BP, white-coat effect was present in 20% and 23% in the intensive and standard groups, respectively. Among participants with controlled office BP, masked uncontrolled hypertension was present in 62% and 56% in the intensive and standard groups, respectively. In conclusion, a more intensive BP target resulted in a similar proportion of patients with white-coat effect and masked uncontrolled hypertension compared with a standard target.",2020,"The prevalence of white-coat effect and masked uncontrolled hypertension was 9% and 34%, in both treatment groups.","['897 participants 27 months after randomization to intensive versus standard BP targets (office systolic BP <120 versus <140 mm Hg', 'White-Coat Effect and Masked Uncontrolled Hypertension', 'participants with white-coat effect (standard target']",['Intensive Versus Standard Office-Based Hypertension Treatment Strategy'],"['prevalence of white-coat effect and masked uncontrolled hypertension', 'uncontrolled hypertension']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}]",27.0,0.101849,"The prevalence of white-coat effect and masked uncontrolled hypertension was 9% and 34%, in both treatment groups.","[{'ForeName': 'Lama', 'Initials': 'L', 'LastName': 'Ghazi', 'Affiliation': 'From the Division of Renal Diseases and Hypertension, University of Minnesota, Minneapolis (L.G., P.E.D.).'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Cohen', 'Affiliation': 'The Columbia Hypertension Center, Columbia University, New York, NY (L.P.C., D.S.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Alabama at Birmingham (P.M.).'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'The Columbia Hypertension Center, Columbia University, New York, NY (L.P.C., D.S.).'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Drawz', 'Affiliation': 'From the Division of Renal Diseases and Hypertension, University of Minnesota, Minneapolis (L.G., P.E.D.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15300']
222,32881572,Measuring positive psychosocial sequelae in patients with advanced cancer.,"OBJECTIVE


Posttraumatic growth and benefit finding describe the potential for positive changes resulting from traumatic experiences, including cancer. In oncology, these constructs are increasingly examined concurrently using the Posttraumatic Growth Inventory (PTGI) and the Benefit Finding Scale (BFS). However, distinctions between these constructs and their corresponding scales are not altogether clear, and the burden of administering 2 lengthy questionnaires is evident, particularly for patients at end-of-life.
METHOD


Baseline data from 209 participants enrolled in a randomized controlled trial evaluating the efficacy of a psychosocial intervention were analyzed. We assessed the structure and covariance of all PTGI and BFS items using item response theory to determine the extent to which these measures overlap and the potential value of their concurrent administration in patients with advanced cancer.
RESULTS


Despite conceptual differences in posttraumatic growth and benefit finding, results indicated that these measures address the same underlying construct. We subsequently analyzed 3 abbreviated scales (7, 11, and 16 items) that combine items from both scales to identify an optimal briefer combined scale. Results supported all 3 versions, with the 7- and 16-item measures appearing to have the best balance of content and concurrent validity and the 11-item version optimizing information gained with brevity.
CONCLUSIONS


These findings indicate that concurrent administration of the PTGI and BFS may be unnecessary given the high degree of overlap between these 2 measures and that a brief subset of items may adequately evaluate positive change among patients with advanced cancer while reducing participant burden. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Results supported all 3 versions, with the 7- and 16-item measures appearing to have the best balance of content and concurrent validity and the 11-item version optimizing information gained with brevity.
","['209 participants enrolled', 'patients with advanced cancer']","['PTGI and BFS', 'psychosocial intervention']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],209.0,0.0248764,"Results supported all 3 versions, with the 7- and 16-item measures appearing to have the best balance of content and concurrent validity and the 11-item version optimizing information gained with brevity.
","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Applebaum', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Marziliano', 'Affiliation': 'Center for Health Innovations and Outcomes Research.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schofield', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Breitbart', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Rosenfeld', 'Affiliation': 'Department of Psychology.'}]","Psychological trauma : theory, research, practice and policy",['10.1037/tra0000944']
223,32894871,Umbilical Cord Milking in Extremely Preterm Infants: A Randomized Controlled Trial Comparing Cord Milking with Immediate Cord Clamping.,"OBJECTIVE


This study aimed to assess potential benefits of umbilical cord milking (UCM) when compared with immediate cord clamping (ICC) in extremely preterm infants.
STUDY DESIGN


This is a single-center, randomized controlled trial of infants 24 0/7  to 27 6/7  weeks' gestation who received UCM versus ICC. In the experimental group, 18 cm of the umbilical cord was milked three times. The primary aim was to assess the initial hemoglobin and to assess the number of blood transfusions received in the first 28 days after birth. Secondary outcomes were also assessed, including intraventricular hemorrhage (IVH). A priori, neurodevelopmental follow-up was planned at 15 to 18 months corrected gestational age (CGA).
RESULTS


Baseline characteristics for 56 enrolled infants were similar in both groups with a mean gestational age of 26.1 ± 1.2 weeks and a mean birth weight of 815 ± 204 g. There were no differences in the mean initial hemoglobin in the UCM group when compared with the ICC group, 13.7 ± 2.0 and 13.8 ± 2.6 g/dL, respectively ( p  = 0.95), with no differences in median number of blood transfusions after birth between the ICC group and the UCM group, 2 (interquartile range [IQR]: 1-4) versus 2.5 (IQR: 1-5) ( p  = 0.40). There was also no difference in the rate of severe IVH. At 15 to 18 months CGA, there were no differences in death or disability in the ICC group compared with the UCM group (26 vs. 22%;  p  = 1.0) and no differences in neurodevelopmental outcomes.
CONCLUSION


In a randomized trial of ICC versus UCM in extremely preterm infants, no differences were seen in initial hemoglobin or number of blood transfusions.
KEY POINTS


· Umbilical cord milking may be an alternative to delayed cord clamping, but its safety and efficacy are not established in extremely premature infants.. · There are minimal available published data on the longer term neurodevelopmental outcomes in extremely premature infants who receive umbilical cord milking compared with immediate clamping.. · We did not find a significant difference in the primary outcomes of initial hemoglobin and blood transfusions between the groups, nor did we find a difference in severe IVH with umbilical cord milking..",2022,"At 15 to 18 months CGA, there were no differences in death or disability in the ICC group compared with the UCM group (26 vs. 22%;  p  = 1.0) and no differences in neurodevelopmental outcomes.
","['extremely premature infants', 'extremely preterm infants', ""infants 24 0/7  to 27 6/7  weeks' gestation who received"", 'Extremely Preterm Infants', '56 enrolled infants were similar in both groups with a mean gestational age of 26.1\u2009±\u20091.2 weeks and a mean birth weight of 815\u2009±\u2009204\u2009g']","['UCM', 'immediate cord clamping (ICC', 'ICC', 'UCM versus ICC', 'Cord Milking with Immediate Cord Clamping', 'umbilical cord milking (UCM']","['median number of blood transfusions', 'severe IVH with umbilical cord milking', 'mean initial hemoglobin', 'Umbilical Cord Milking', 'initial hemoglobin', 'neurodevelopmental outcomes', 'number of blood transfusions', 'death or disability', 'rate of severe IVH', 'initial hemoglobin and blood transfusions', 'initial hemoglobin or number of blood transfusions', 'intraventricular hemorrhage (IVH']","[{'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}]",56.0,0.300976,"At 15 to 18 months CGA, there were no differences in death or disability in the ICC group compared with the UCM group (26 vs. 22%;  p  = 1.0) and no differences in neurodevelopmental outcomes.
","[{'ForeName': 'Justin B', 'Initials': 'JB', 'LastName': 'Josephsen', 'Affiliation': 'Department of Pediatrics, Saint Louis University, St. Louis, Missouri.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Potter', 'Affiliation': ""Department of Obstetrics, Gynecology, and Women's Health, Saint Louis University, St. Louis, Missouri.""}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Armbrecht', 'Affiliation': 'Saint Louis University Center for Outcomes Research, Saint Louis University, St. Louis, Missouri.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Al-Hosni', 'Affiliation': 'Department of Pediatrics, Saint Louis University, St. Louis, Missouri.'}]",American journal of perinatology,['10.1055/s-0040-1716484']
224,32907642,School age effects of Minding the Baby-An attachment-based home-visiting intervention-On parenting and child behaviors.,"Multiple interventions have been developed to improve the caregiver-child relationship as a buffer to the effects of early life adversity and toxic stress. However, relatively few studies have evaluated the long-term effects of these early childhood interventions, particularly on parenting and childhood behaviors. Here we describe the early school-age follow-up results of a randomized controlled trial of Minding the Baby ® (MTB), a reflective, attachment-based, trauma-informed, preventive home-visiting intervention for first-time mothers and their infants. Results indicate that mothers who participated in MTB are less likely to show impaired mentalizing compared to control mothers two to eight years after the intervention ended. Additionally, MTB mothers have lower levels of hostile and coercive parenting, and their children have lower total and externalizing problem behavior scores when compared to controls at follow-up. We discuss our findings in terms of their contribution to understanding the long-term parenting and childhood socio-emotional developmental effects of early preventive interventions for stressed populations.",2022,Results indicate that mothers who participated in MTB are less likely to show impaired mentalizing compared to control mothers two to eight years after the intervention ended.,['first-time mothers and their infants'],['Minding the Baby ® (MTB'],"['levels of hostile and coercive parenting', 'total and externalizing problem behavior scores']","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0320566,Results indicate that mothers who participated in MTB are less likely to show impaired mentalizing compared to control mothers two to eight years after the intervention ended.,"[{'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Londono Tobon', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Condon', 'Affiliation': 'Yale School of Nursing, New Haven, CT, USA.'}, {'ForeName': 'Lois S', 'Initials': 'LS', 'LastName': 'Sadler', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Holland', 'Affiliation': 'Yale School of Nursing, New Haven, CT, USA.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Mayes', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Arietta', 'Initials': 'A', 'LastName': 'Slade', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}]",Development and psychopathology,['10.1017/S0954579420000905']
225,32896504,"Early, short-term, low-dose glucocorticoid therapy effectively blocks progression of severe acute exacerbation of chronic hepatitis B to liver failure.","OBJECTIVE


To determine whether early, short-term, low-dose glucocorticoid treatment prevents the progression of severe acute exacerbation of chronic hepatitis B to liver failure.
METHODS


We prospectively enrolled 125 patients with severe acute exacerbation of chronic hepatitis B from the Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University between September 2013 and March 2016. The patients were randomized to a hormone group (3-day, low-dose glucocorticoid treatment plus conventional treatment; 63 patients) and a control group (conventional treatment only; 62 patients). We analyzed markers of liver function, complications, mortality rates, and duration and cost of hospitalization.
RESULTS


Serum alanine transaminase levels were significantly lower in the hormone group than in the control group at 3 days (P = 0.009) and 1 week (P = 0.018) after treatment. The decrease in this level from the baseline value on day 3 was greater in the hormone group than in the control group (P = 0.023). The trend of the changes in this level significantly differed between the two groups (P = 0.008). The incidence of liver failure (8.06% vs. 30.16%; P = 0.002) and the duration of hospitalization (23.79 vs. 31.79 days; P = 0.031) were significantly lower in the hormone group than in the control group.
CONCLUSION


Low-dose, short-term glucocorticoid treatment early in the course of severe acute exacerbation of chronic hepatitis B along with conventional treatment significantly reduced the risk of progression to liver failure and shortened the duration of hospitalization, without increasing the complication rate.",2021,"The incidence of liver failure (8.06% vs. 30.16%; P = 0.002) and the duration of hospitalization (23.79 vs. 31.79 days; P = 0.031) were significantly lower in the hormone group than in the control group.
","['chronic hepatitis B to liver failure', '125 patients with severe acute exacerbation of chronic hepatitis B from the Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University between September 2013 and March 2016']","['glucocorticoid therapy', 'hormone group (3-day, low-dose glucocorticoid treatment plus conventional treatment; 63 patients) and a control group (conventional treatment', 'glucocorticoid treatment']","['liver function, complications, mortality rates, and duration and cost of hospitalization', 'duration of hospitalization', 'Serum alanine transaminase levels', 'complication rate', 'incidence of liver failure', 'risk of progression to liver failure']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",125.0,0.0242439,"The incidence of liver failure (8.06% vs. 30.16%; P = 0.002) and the duration of hospitalization (23.79 vs. 31.79 days; P = 0.031) were significantly lower in the hormone group than in the control group.
","[{'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Zhe-Bin', 'Affiliation': 'Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou City, 510630, PR China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Ke', 'Affiliation': 'Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou City, 510630, PR China.'}, {'ForeName': 'Zhi-Shuo', 'Initials': 'ZS', 'LastName': 'Mo', 'Affiliation': 'Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou City, 510630, PR China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhen', 'Affiliation': 'Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou City, 510630, PR China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Yu-Bao', 'Affiliation': 'Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou City, 510630, PR China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ying', 'Affiliation': 'Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou City, 510630, PR China.'}, {'ForeName': 'Gao', 'Initials': 'G', 'LastName': 'Zhi-Liang', 'Affiliation': 'Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou City, 510630, PR China. Electronic address: gaozl@mail.sysu.edu.cn.'}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2020.07.010']
226,32906135,Tubular Biomarkers and Chronic Kidney Disease Progression in SPRINT Participants.,"BACKGROUND


Kidney tubular atrophy on biopsy is a strong predictor of chronic kidney disease (CKD) progression, but tubular health is poorly quantified by traditional measures including estimated glomerular filtration rate (eGFR) and albuminuria. We hypothesized that urinary biomarkers of impaired tubule function would be associated with faster eGFR declines in persons with CKD.
METHODS


We measured baseline urine concentrations of uromodulin, β2-microglobulin (β2m), and α1-microglobulin (α1m) among 2,428 participants of the Systolic Blood Pressure Intervention Trial with an eGFR <60 mL/min/1.73 m2. We used linear mixed models to evaluate biomarker associations with annualized relative change in eGFR, stratified by randomization arm.
RESULTS


At baseline, the mean age was 73 ± 9 years and eGFR was 46 ± 11 mL/min/1.73 m2. In the standard blood pressure treatment arm, each 2-fold higher urinary uromodulin was associated with slower % annual eGFR decline (0.34 [95% CI: 0.08, 0.60]), whereas higher urinary β2m was associated with faster % annual eGFR decline (-0.10 [95% CI: -0.18, -0.02]) in multivariable-adjusted models including baseline eGFR and albuminuria. Associations were weaker and did not reach statistical significance in the intensive blood pressure treatment arm for either uromodulin (0.11 [-0.13, 0.35], p value for interaction by treatment arm = 0.045) or β2m (-0.01 [-0.08, 0.08], p value for interaction = 0.001). Urinary α1m was not independently associated with eGFR decline in the standard (0.01 [-0.22, 0.23]) or intensive (0.03 [-0.20, 0.25]) arm.
CONCLUSIONS


Among trial participants with hypertension and CKD, baseline measures of tubular function were associated with subsequent declines in kidney function, although these associations were diminished by intensive blood pressure control.",2020,"In the standard blood pressure treatment arm, each 2-fold higher urinary uromodulin was associated with slower % annual eGFR decline (0.34 [95% CI: 0.08, 0.60]), whereas higher urinary β2m was associated with faster % annual eGFR decline (-0.10","['2,428 participants of the Systolic Blood Pressure Intervention Trial with an eGFR <60 mL/min/1.73 m2', 'persons with CKD', 'SPRINT Participants']",[],"['baseline urine concentrations of uromodulin, β2-microglobulin (β2m), and α1-microglobulin (α1m', 'Tubular Biomarkers and Chronic Kidney Disease Progression', 'annual eGFR decline', 'eGFR decline', 'intensive blood pressure control', 'kidney function', 'Urinary α1m', 'glomerular filtration rate (eGFR) and albuminuria']","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0077918', 'cui_str': 'Uromucoid protein'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]",2428.0,0.0823971,"In the standard blood pressure treatment arm, each 2-fold higher urinary uromodulin was associated with slower % annual eGFR decline (0.34 [95% CI: 0.08, 0.60]), whereas higher urinary β2m was associated with faster % annual eGFR decline (-0.10","[{'ForeName': 'Vasantha', 'Initials': 'V', 'LastName': 'Jotwani', 'Affiliation': 'Department of Medicine, San Francisco VA Medical Health Care System, San Francisco, California, USA, vasantha.jotwani@ucsf.edu.'}, {'ForeName': 'Pranav S', 'Initials': 'PS', 'LastName': 'Garimella', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bates', 'Affiliation': 'Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Drawz', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Department of Medicine, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Killeen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'Punzi Medical Center, Trinity Hypertension Research Institute, Carollton, Texas, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sarnak', 'Affiliation': 'Department of Medicine, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Segal', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Department of Medicine, San Francisco VA Medical Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of nephrology,['10.1159/000509978']
227,32820475,Vasopressor Therapy in the Intensive Care Unit.,"After fluid administration for vasodilatory shock, vasopressors are commonly infused. Causes of vasodilatory shock include septic shock, post-cardiovascular surgery, post-acute myocardial infarction, postsurgery, other causes of an intense systemic inflammatory response, and drug -associated anaphylaxis. Therapeutic vasopressors are hormones that activate receptors-adrenergic: α1, α2, β1, β2; angiotensin II: AG1, AG2; vasopressin: AVPR1a, AVPR1B, AVPR2; dopamine: DA1, DA2. Vasopressor choice and dose vary widely because of patient and physician practice heterogeneity. Vasopressor adverse effects are excessive vasoconstriction causing organ ischemia/infarction, hyperglycemia, hyperlactatemia, tachycardia, and tachyarrhythmias. To date, no randomized controlled trial (RCT) of vasopressors has shown a decreased 28-day mortality rate. There is a need for evidence regarding alternative vasopressors as first-line vasopressors. We emphasize that vasopressors should be administered simultaneously with fluid replacement to prevent and decrease duration of hypotension in shock with vasodilation. Norepinephrine is the first-choice vasopressor in septic and vasodilatory shock. Interventions that decrease norepinephrine dose (vasopressin, angiotensin II) have not decreased 28-day mortality significantly. In patients not responsive to norepinephrine, vasopressin or epinephrine may be added. Angiotensin II may be useful for rapid resuscitation of profoundly hypotensive patients. Inotropic agent(s) (e.g., dobutamine) may be needed if vasopressors decrease ventricular contractility. Dopamine has fallen to almost no-use recommendation because of adverse effects; angiotensin II is available clinically; there are potent vasopressors with scant literature (e.g., methylene blue); and the novel V1a agonist selepressin missed on its pivotal RCT primary outcome. In pediatric septic shock, vasopressors, epinephrine, and norepinephrine are recommended equally because there is no clear evidence that supports the use of one vasoactive agent. Dopamine is recommended when epinephrine or norepinephrine is not available. New strategies include perhaps patients will be  started  on several vasopressors with complementary mechanisms of action, patients may be selected for particular vasopressors according to predictive biomarkers, and novel vasopressors may emerge with fewer adverse effects.",2021,"Interventions that decrease norepinephrine dose (vasopressin, angiotensin II) have not decreased 28-day mortality significantly.",[],"['Vasopressor Therapy', 'epinephrine or norepinephrine', 'Dopamine', 'Angiotensin', 'norepinephrine, vasopressin or epinephrine', 'norepinephrine dose (vasopressin, angiotensin II', 'Norepinephrine']","['28-day mortality rate', '28-day mortality', 'duration of hypotension']",[],"[{'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",,0.232552,"Interventions that decrease norepinephrine dose (vasopressin, angiotensin II) have not decreased 28-day mortality significantly.","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Russell', 'Affiliation': ""Department of Medicine, Centre for Heart Lung Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Department of Surgery and Cancer, Division of Anaesthetics, Pain Medicine and Intensive Care, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine, Indiana University Health Methodist Hospital, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Boyd', 'Affiliation': ""Department of Medicine, Centre for Heart Lung Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Walley', 'Affiliation': ""Department of Medicine, Centre for Heart Lung Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Kissoon', 'Affiliation': ""Department of Pediatrics, British Columbia Children's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}]",Seminars in respiratory and critical care medicine,['10.1055/s-0040-1710320']
228,32830368,"Time-varying effects of 'optimized smoking treatment' on craving, negative affect and anhedonia.","AIMS


To identify when smoking cessation treatments affect craving, negative affect and anhedonia, and how these symptoms relate to abstinence, to help evaluate the effects of particular intervention components in multi-component treatments and accelerate treatment refinement.
DESIGN


Secondary analysis of data from a two-arm randomized controlled trial.
SETTING


Seven primary care clinics in Wisconsin, United States.
PARTICIPANTS


Adult primary care patients who smoked daily (n = 574).
INTERVENTION AND COMPARATOR


Intervention was abstinence-optimized treatment (A-OT, n = 276) comprising 3 weeks of nicotine mini-lozenges pre-target quit day (TQD), 26 weeks of combination nicotine patch and mini-lozenges post-TQD and extensive psychosocial support. The comparator was recommended usual care (RUC, n = 298), comprising brief counseling and 8 weeks of nicotine patch post-TQD.
MEASUREMENTS


Time-varying effect models examined dynamic effects of A-OT (versus RUC) on the primary outcomes of nightly cigarette craving, negative affect and anhedonia from 1 week pre- to 2 weeks post-TQD. Exploratory models examined within-person relations between nicotine medication use and same-day symptom ratings. Secondary logistic regression analyses examined associations between post-TQD craving, negative affect and anhedonia and 1-month post-TQD abstinence.
FINDINGS


A-OT significantly suppressed pre- and post-TQD craving (β = -0.27 to -0.46 across days) and post-TQD anhedonia (β = -0.24 to -0.38 across days), relative to RUC. Within individuals, using patches was associated with lower negative affect in RUC (β = -0.42 to -0.52), but not in A-OT. Using more mini-lozenges was associated with greater craving (β = 0.04-0.07) and negative affect (β = 0.03-0.05) early, and with lower anhedonia (β = -0.06 to -0.12) later. Greater post-TQD craving (OR = 0.68) and anhedonia (OR = 0.85) predicted lower odds of abstinence 1 month post-TQD.
CONCLUSION


Time-varying effect models showed that a multi-component treatment intervention for smoking cessation suppressed significant withdrawal symptoms more effectively than recommended usual care among daily adult smokers motivated to quit. The intervention reduced craving pre- and post-target quit day (TQD) and anhedonia post-TQD.",2021,"Using more mini-lozenges was associated with greater craving (β=0.04 to 0.07) and negative affect (β=0.03 to 0.05) early, and with lower anhedonia (β=-0.06 to -0.12) later.","['Seven primary care clinics in Wisconsin, USA', 'Adult primary care patients who smoked daily (N=574']","['nicotine mini-lozenges pre-target quit day (TQD), 26 weeks of combination nicotine patch and mini-lozenges post-TQD, and extensive psychosocial support', 'nicotine patch post-TQD']","['post-TQD anhedonia', 'nightly cigarette craving, negative affect, and anhedonia', 'post-TQD craving, negative affect and anhedonia and 1-month post-TQD abstinence', 'Craving, Negative Affect, and Anhedonia', 'Greater post-TQD craving', 'anhedonia', 'Time-varying effect models examined dynamic effects of A-OT (versus RUC', 'pre- and post-TQD craving', 'RUC', 'craving pre- and post-target quit day (TQD) and anhedonia post-TQD', 'greater craving', 'lower anhedonia', 'withdrawal symptoms']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0523964', 'cui_str': 'Urea nitrogen renal clearance measurement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}]",,0.0239201,"Using more mini-lozenges was associated with greater craving (β=0.04 to 0.07) and negative affect (β=0.03 to 0.05) early, and with lower anhedonia (β=-0.06 to -0.12) later.","[{'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'McCarthy', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Schlam', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention, Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15232']
229,32838463,"Effect of Local Infiltration Analgesia on Functional Outcomes in Total Knee Arthroplasty: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial.","Local infiltration analgesia (LIA) is a simple, surgeon-administered technique for the treatment of postoperative pain after total knee arthroplasty (TKA). The aim of the study was to investigate the efficacy of LIA and its effects on functional outcomes in TKA. A total of 135 patients with primary TKA were recruited and randomized either to receive LIA or to receive placebo injection (PI). Pain, active range of motion (ROM), knee function score, functional activities, and hospital length of stay (LOS) were assessed before surgery and from postoperative day (POD) 1 to at discharge. Lower pain scores at rest were recorded on POD1 and POD2 in the LIA group ( p  = 0.027 and  p  = 0.020, respectively). Lower pain score on walking was recorded on POD1 in the LIA group ( p  = 0.002). There was a statistically significant difference in active knee flexion between groups on POD1 ( p  = 0.038). There was a significant difference in LOS between LIA and PI groups. Shorter stay was seen in LIA group. There were no statistically significant differences between the groups in terms of knee function score and functional outcomes. LIA technique is effective for pain management in the early postoperative period. LIA added benefit for knee function in terms of active knee flexion ROM after TKA. A shorter hospital LOS was observed in LIA group. However, we did not find any differences in groups in terms of functional assessment such as ability to rise from a chair and walking capacity.The level of evidence is randomized controlled trial, level I.",2022,There was a statistically significant difference in active knee flexion between groups on POD1 ( p  = 0.038).,"['135 patients with primary TKA', 'Total Knee Arthroplasty', 'postoperative pain after total knee arthroplasty (TKA']","['Local Infiltration Analgesia', 'LIA technique', 'Local infiltration analgesia (LIA', 'LIA', 'Placebo', 'placebo injection (PI']","['Pain, active range of motion (ROM), knee function score, functional activities, and hospital length of stay (LOS', 'knee function score and functional outcomes', 'hospital LOS', 'Lower pain scores', 'POD1 and POD2', 'Shorter stay', 'LOS', 'active knee flexion', 'Lower pain score on walking', 'Functional Outcomes']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]","[{'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}]",135.0,0.255896,There was a statistically significant difference in active knee flexion between groups on POD1 ( p  = 0.038).,"[{'ForeName': 'Bayram', 'Initials': 'B', 'LastName': 'Unver', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylul University, Balçova, Izmir, Turkey.'}, {'ForeName': 'Ertugrul', 'Initials': 'E', 'LastName': 'Yuksel', 'Affiliation': 'Graduate School of Health Sciences, Dokuz Eylul University, Balçova, Izmir, Turkey.'}, {'ForeName': 'Musa', 'Initials': 'M', 'LastName': 'Eymir', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylul University, Balçova, Izmir, Turkey.'}, {'ForeName': 'Fikret', 'Initials': 'F', 'LastName': 'Maltepe', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Dokuz Eylul University, Balçova, Izmir, Turkey.'}, {'ForeName': 'Vasfi', 'Initials': 'V', 'LastName': 'Karatosun', 'Affiliation': 'Department of Orthopedics and Traumatology, School of Medicine, Dokuz Eylul University, Balçova, Izmir, Turkey.'}]",The journal of knee surgery,['10.1055/s-0040-1715103']
230,32873114,Placebo effects on the quantity and quality of relaxation training.,"Many people find it difficult to practice progressive muscle relaxation (PMR) regularly. We attempted to improve relaxation quantity (i.e. adherence), and relaxation quality via placebo. A total of 100 women were randomly assigned to a standard group, which practiced PMR at home every day for two weeks, or a placebo group, which practiced PMR for two weeks with additional daily placebo treatment. To monitor adherence to relaxation practice, we used a smartphone app. The placebo group practiced more often than the standard group. Both groups did not differ in their reported relaxation level after the daily exercises.",2022,The placebo group practiced more often than the standard group.,['A total of 100 women'],"['placebo', 'Placebo', 'placebo treatment']","['quantity and quality of relaxation training', 'relaxation level', 'relaxation quantity (i.e. adherence), and relaxation quality']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",100.0,0.2711,The placebo group practiced more often than the standard group.,"[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Höfler', 'Affiliation': 'Department of Clinical Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Osmani', 'Affiliation': 'Department of Clinical Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schienle', 'Affiliation': 'Department of Clinical Psychology, University of Graz, Graz, Austria.'}]",Journal of health psychology,['10.1177/1359105320954238']
231,32924893,A multiple levels of analysis examination of the performance goal model of depression vulnerability in preadolescent children.,"If performance goals (i.e., motivation to prove ability) increase children's vulnerability to depression (Dykman, 1998), why are they overlooked in the psychopathology literature? Evidence has relied on self-report or observational methods and has yet to articulate how this vulnerability unfolds across levels of analysis implicated in stress-depression linkages; for example, hypothalamic-pituitaryadrenal axis (HPA), sympathetic nervous system (SNS). Utilizing a multiple-levels-of-analysis approach (Cicchetti, 2010), this experimental study tested Dykman's goal orientation model of depression vulnerability in a community sample of preadolescents (N = 121, Mage = 10.60 years, Range = 9.08-12.00 years, 51.6% male). Self-reports of performance goals, attachment security, and subjective experience of internalizing difficulties were obtained in addition to objective behavioral (i.e., task persistence) and physiologic arousal (i.e., salivary cortisol, skin conductance level) responses to the Trier Social Stress Test (TSST) and two randomly assigned coping conditions: avoidance, distraction. Children with performance goals reported greater internalizing difficulties and exhibited more dysregulated TSST physiologic responses (i.e., HPA hyperreactivity, SNS protracted recovery), yet unexpectedly displayed greater TSST task persistence and more efficient physiologic recovery during avoidance relative to distraction. These associations were stronger and nonsignificant in the context of insecure and secure attachment, respectively. Findings illustrate a complex matrix of in-the-moment, integrative psychobiological relationships linking performance goals to depression vulnerability.",2022,"Children with performance goals reported greater internalizing difficulties and exhibited more dysregulated TSST physiologic responses (i.e., HPA hyperreactivity, SNS protracted recovery), yet unexpectedly displayed greater TSST task persistence and more efficient physiologic recovery during avoidance relative to distraction.","['preadolescent children', 'depression vulnerability in a community sample of preadolescents (N = 121, Mage = 10.60 years, Range = 9.08-12.00 years, 51.6% male']","['Trier Social Stress Test (TSST) and two randomly assigned coping conditions: avoidance, distraction']","['objective behavioral (i.e., task persistence) and physiologic arousal (i.e., salivary cortisol, skin conductance level) responses', 'TSST task persistence', 'dysregulated TSST physiologic responses']","[{'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]",,0.0588605,"Children with performance goals reported greater internalizing difficulties and exhibited more dysregulated TSST physiologic responses (i.e., HPA hyperreactivity, SNS protracted recovery), yet unexpectedly displayed greater TSST task persistence and more efficient physiologic recovery during avoidance relative to distraction.","[{'ForeName': 'Jason José', 'Initials': 'JJ', 'LastName': 'Bendezú', 'Affiliation': 'The Institute of Child Development, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alaina', 'Initials': 'A', 'LastName': 'Wodzinski', 'Affiliation': 'Department of Psychology, Montclair State University, Montclair, NJ, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Loughlin-Presnal', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Mozeko', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Sierra', 'Initials': 'S', 'LastName': 'Cobler', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Martha E', 'Initials': 'ME', 'LastName': 'Wadsworth', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park, PA, USA.'}]",Development and psychopathology,['10.1017/S0954579420000851']
232,32858063,Dietary Nutrient Intake and Progression to Late Age-Related Macular Degeneration in the Age-Related Eye Disease Studies 1 and 2.,"PURPOSE


To analyze associations between the dietary intake of multiple nutrients and risk of progression to late age-related macular degeneration (AMD), its subtypes, and large drusen.
DESIGN


Post hoc analysis of 2 controlled clinical trial cohorts: Age-Related Eye Disease Study (AREDS) and AREDS2.
PARTICIPANTS


Eyes with no late AMD at baseline among AREDS participants (n = 4504) and AREDS2 participants (n = 3738) totaled 14 135 eyes. Mean age was 71.0 years (standard deviation, 6.7 years), and 56.5% of patients were women.
METHODS


Fundus photographs were collected at annual study visits and graded centrally for late AMD. Dietary intake of multiple nutrients was calculated from food frequency questionnaires.
MAIN OUTCOME MEASURES


Progression to late AMD, geographic atrophy (GA), neovascular AMD, and (separate analyses) large drusen.
RESULTS


Over median follow-up of 10.2 years, of the 14 135 eyes, 32.7% progressed to late AMD. For 9 nutrients, intake quintiles 4 or 5 (vs. 1) were associated significantly (P ≤ 0.0005) with decreased risk of late AMD: vitamin A, vitamin B6, vitamin C, folate, β-carotene, lutein and zeaxanthin, magnesium, copper, and alcohol. For 3 nutrients, quintiles 4 or 5 were associated significantly with increased risk: saturated fatty acid, monounsaturated fatty acid, and oleic acid. Similar results were observed for GA. Regarding neovascular AMD, 9 nutrients were associated nominally with decreased risk-vitamin A, vitamin B6, β-carotene, lutein and zeaxanthin, magnesium, copper, docosahexaenoic acid, omega-3 fatty acid, and alcohol-and 3 nutrients were associated with increased risk-saturated fatty acid, monounsaturated fatty acid, and oleic acid. In separate analyses (n = 5399 eyes of 3164 AREDS participants), 12 nutrients were associated nominally with decreased risk of large drusen.
CONCLUSIONS


Higher dietary intake of multiple nutrients, including minerals, vitamins, and carotenoids, is associated with decreased risk of progression to late AMD. These associations are stronger for GA than for neovascular AMD. The same nutrients also tend to show protective associations against large drusen development. Strong genetic interactions exist for some nutrient-genotype combinations, particularly omega-3 fatty acids and CFH. These data may justify further research into underlying mechanisms and randomized trials of supplementation.",2021,"For nine nutrients, intake quintiles 4 or 5 (versus 1) were significantly (P≤0.0005) associated with decreased risk of late AMD: vitamins A, B6, and C, folate, β-carotene, lutein/zeaxanthin, magnesium, copper, and alcohol.","['Mean age was 71.0 years (SD 6.7); 56.5% were female', 'two controlled clinical trial cohorts: Age-Related Eye Disease Study (AREDS; recruitment 1992-8) and AREDS2 (recruitment 2006-8', 'Eyes with no late AMD at baseline in AREDS participants (n=4,504) and AREDS2 participants (n=3,738): total of 14,135 eyes', 'Fundus photographs were collected at annual study visits and graded centrally for late AMD']",[],"['risk of large drusen', 'Progression to late AMD, geographic atrophy (GA), neovascular AMD, and (separate analyses) large drusen', 'risk (vitamins A and B6, β-carotene, lutein/zeaxanthin, magnesium, copper, docosahexaenoic acid, omega-3 fatty acid, and alcohol', 'risk: saturated fatty acid, monounsaturated fatty acid, and oleic acid', 'risk of late AMD: vitamins A, B6, and C, folate, β-carotene, lutein/zeaxanthin, magnesium, copper, and alcohol']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0456592', 'cui_str': '1992'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0035312', 'cui_str': 'Retinal drusen'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0007269', 'cui_str': 'Carotene'}, {'cui': 'C2929534', 'cui_str': 'Lutein / zeaxanthin'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0028928', 'cui_str': '9 cis-octadecenoic acid'}, {'cui': 'C0178638', 'cui_str': 'Folate'}]",9.0,0.0446104,"For nine nutrients, intake quintiles 4 or 5 (versus 1) were significantly (P≤0.0005) associated with decreased risk of late AMD: vitamins A, B6, and C, folate, β-carotene, lutein/zeaxanthin, magnesium, copper, and alcohol.","[{'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Agrón', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mares', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'The Emmes Company LLC, Rockville, Maryland.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Swaroop', 'Affiliation': 'Neurobiology-Neurodegeneration and Repair Laboratory, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: echew@nei.nih.gov.'}, {'ForeName': 'Tiarnan D L', 'Initials': 'TDL', 'LastName': 'Keenan', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: tiarnan.keenan@nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.08.018']
233,32898921,Validation of an Instrument for Real-Time Assessment of Neonatal Intubation Skills: A Randomized Controlled Simulation Study.,"OBJECTIVE


This study aimed to evaluate the construct validity and reliability of real-time assessment of a previously developed neonatal intubation scoring instrument (NISI).
STUDY DESIGN


We performed a randomized controlled simulation study at a simulation-based research and training facility. Twenty-four clinicians experienced in neonatal intubation (""experts"") and 11 medical students (""novices"") performed two identical elective intubations on a neonatal patient simulator. Subjects were randomly assigned to either the intervention group, receiving predefined feedback between the two intubations, or the control group, receiving no feedback. Using the previously developed NISI, all intubations were assessed, both in real time and remotely on video. Construct validity was evaluated by (1) comparing the intubation performances, expressed as percentage scores, with and without feedback, and (2) correlating the intubation performances with the subjects' level of experience. The intrarater reliability, expressed as intraclass correlation coefficient (ICC), of real-time assessment compared with video-based assessment was determined.
RESULTS


The intervention group contained 18 subjects, the control group 17. Background characteristics and baseline intubation scores were comparable in both groups. The median (IQR) change in percentage scores between the first and second intubation was significantly different between the intervention and control group (11.6% [4.7-22.8%] vs. 1.4% [0.0-5.7%], respectively;  p  = 0.013). The 95% CI for this 10.2% difference was 2.2 to 21.4%. The subjects' experience level correlated significantly with their percentage scores (Spearman's  R  = 0.70;  p < 0.01). ICC's were 0.95 (95% CI: 0.89-0.97) and 0.94 (95% CI: 0.89-0.97) for the first and second intubation, respectively.
CONCLUSION


Our NISI has construct validity and is reliable for real-time assessment.
KEY POINTS


· Our neonatal intubation scoring instrument has construct validity.. · Our instrument can be reliably employed to assess neonatal intubation skills directly in real time.. · It is suitable for formative assessment, i.e., providing direct feedback during procedural training..",2022,"The median (IQR) change in percentage scores between the first and second intubation was significantly different between the intervention and control group (11.6% [4.7-22.8%] vs. 1.4% [0.0-5.7%], respectively;  p  = 0.013).","['Twenty-four clinicians experienced in neonatal intubation (""experts"") and 11 medical students (""novices"") performed two identical elective intubations on a neonatal patient simulator', 'Neonatal Intubation Skills']","['neonatal intubation scoring instrument (NISI', 'control group, receiving no feedback']","[' characteristics and baseline intubation scores', 'intraclass correlation coefficient (ICC), of real-time assessment', 'median (IQR) change in percentage scores']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",,0.112193,"The median (IQR) change in percentage scores between the first and second intubation was significantly different between the intervention and control group (11.6% [4.7-22.8%] vs. 1.4% [0.0-5.7%], respectively;  p  = 0.013).","[{'ForeName': 'Lindie J M K', 'Initials': 'LJMK', 'LastName': 'Kuijpers', 'Affiliation': ""Department of Neonatology, Radboud University Medical Center Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'Mathijs', 'Initials': 'M', 'LastName': 'Binkhorst', 'Affiliation': ""Department of Neonatology, Radboud University Medical Center Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'Nicole K', 'Initials': 'NK', 'LastName': 'Yamada', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Department of Pediatrics, Center for Advanced Pediatric and Perinatal Education (CAPE), Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Romy N', 'Initials': 'RN', 'LastName': 'Bouwmeester', 'Affiliation': ""Department of Neonatology, Radboud University Medical Center Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'Arno F J', 'Initials': 'AFJ', 'LastName': 'van Heijst', 'Affiliation': ""Department of Neonatology, Radboud University Medical Center Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'Louis P', 'Initials': 'LP', 'LastName': 'Halamek', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Department of Pediatrics, Center for Advanced Pediatric and Perinatal Education (CAPE), Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Hogeveen', 'Affiliation': ""Department of Neonatology, Radboud University Medical Center Amalia Children's Hospital, Nijmegen, The Netherlands.""}]",American journal of perinatology,['10.1055/s-0040-1715530']
234,32915236,Effect of Peer Mentors in Diabetes Self-management vs Usual Care on Outcomes in US Veterans With Type 2 Diabetes: A Randomized Clinical Trial.,"Importance


Diabetes is a substantial public health issue. Peer mentoring is a low-cost intervention for improving glycemic control in patients with diabetes. However, long-term effects of peer mentoring and creation of sustainable models are not well studied.
Objective


Assess the effects of a peer support intervention for improving glycemic control in patients with diabetes and evaluate a model in which former mentees serve as mentors.
Design, Setting, and Participants


A randomized clinical trial was conducted from September 27, 2012, to March 21, 2018, at the Corporal Michael J. Crescenz Medical Center. US veterans with type 2 diabetes aged 30 to 75 years with hemoglobin A1C (HbA1c) greater than 8% received support over 6 months from peers with prior poor glycemic control but who had achieved HbA1c less than or equal to 7.5% (phase 1). Phase 1 mentees were then randomized to become a mentor or not to new randomly assigned participants in phase 2. Outcomes were assessed at 6 and 12 months. Data were analyzed from October 5, 2016, to September 4, 2018.
Interventions


Mentors who received an initial training session and monthly reinforcement training were assigned 1 mentee and given $20 for each month they contacted their mentee at least weekly.
Main Outcomes and Measures


Primary outcome was HbA1c change at 6 months. Secondary outcomes included HbA1c change at 12 months and change in low-density lipoprotein, blood pressure, diabetes quality of life, and depression symptoms at 6 and 12 months.
Results


The study enrolled 365 participants into phase 1 and 122 participants into phase 2. Most participants were Black (341 [66%]) and male (454 [96%]), with a mean (SD) age of 60 (7.5) years. Mean phase 1 HbA1c change at 6 months for usual care was -0.20% (95% CI, -0.46% to 0.06%) vs -0.52% (95% CI, -0.76% to -0.29%) for mentees (P = .06). Mean phase 2 HbA1c change at 6 months for usual care was -0.46% (95% CI, -1.02% to 0.10%) vs 0.08% (95% CI, -0.42% to 0.57%) for mentees (P = .16). There were no differences in secondary outcomes or HbA1c levels at 12 months. There was no benefit to past mentees who became mentors.
Conclusions and Relevance


In this randomized clinical trial, a peer mentor intervention did not improve 6-month HbA1c levels and did not have sustained benefits.
Trial Registration


ClinicalTrials.gov Identifier: NCT01651117.",2020,"Mean phase 2 HbA1c change at 6 months for usual care was -0.46% (95% CI, -1.02% to 0.10%) vs 0.08% (95% CI, -0.42% to 0.57%) for mentees (P = .16).","['US Veterans With Type 2 Diabetes', 'Diabetes', '365 participants into phase 1 and 122 participants into phase 2', 'Most participants were Black (341 [66%]) and male (454 [96%]), with a mean (SD) age of 60 (7.5) years', 'September 27, 2012, to March 21, 2018, at the Corporal Michael J. Crescenz Medical Center', 'patients with diabetes', 'US veterans with type 2 diabetes aged 30 to 75 years with hemoglobin A1C (HbA1c) greater than 8% received support over 6 months from peers with prior poor glycemic control but who had achieved HbA1c less than or equal to 7.5% (phase 1', 'patients with diabetes and evaluate a model in which former mentees serve as mentors']","['Self-management vs Usual Care', 'Peer Mentors', 'Peer mentoring', 'peer support intervention', 'initial training session and monthly reinforcement training']","['secondary outcomes or HbA1c levels', 'HbA1c change at 6 months', '6-month HbA1c levels', 'HbA1c change at 12 months and change in low-density lipoprotein, blood pressure, diabetes quality of life, and depression symptoms']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",365.0,0.150273,"Mean phase 2 HbA1c change at 6 months for usual care was -0.46% (95% CI, -1.02% to 0.10%) vs 0.08% (95% CI, -0.42% to 0.57%) for mentees (P = .16).","[{'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Long', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, VA Center for Health Equity Research and Promotion, Philadelphia, Pennsylvania.'}, {'ForeName': 'Valerie S', 'Initials': 'VS', 'LastName': 'Ganetsky', 'Affiliation': 'Division of Addiction Medicine and Urban Health Institute, Cooper University Hospital, Camden, New Jersey.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Canamucio', 'Affiliation': 'Veterans Integrated Service Network 4, Center for Evaluation of PACT, Philadelphia, Pennsylvania.'}, {'ForeName': 'Tanisha N', 'Initials': 'TN', 'LastName': 'Dicks', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, VA Center for Health Equity Research and Promotion, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Marcus', 'Affiliation': 'School of Social Policy and Practice, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.16369']
235,32929215,Ketamine modulates fronto-striatal circuitry in depressed and healthy individuals.,"Ketamine improves motivation-related symptoms in depression but simultaneously elicits similar symptoms in healthy individuals, suggesting that it might have different effects in health and disease. This study examined whether ketamine affects the brain's fronto-striatal system, which is known to drive motivational behavior. The study also assessed whether inflammatory mechanisms-which are known to influence neural and behavioral motivational processes-might underlie some of these changes. These questions were explored in the context of a double-blind, placebo-controlled, crossover trial of ketamine in 33 individuals with treatment-resistant major depressive disorder (TRD) and 25 healthy volunteers (HVs). Resting-state functional magnetic resonance imaging (rsfMRI) was acquired 2 days post-ketamine (final sample: TRD n = 27, HV n = 19) and post-placebo (final sample: TRD n = 25, HV n = 18) infusions and was used to probe fronto-striatal circuitry with striatal seed-based functional connectivity. Ketamine increased fronto-striatal functional connectivity in TRD participants toward levels observed in HVs while shifting the connectivity profile in HVs toward a state similar to TRD participants under placebo. Preliminary findings suggest that these effects were largely observed in the absence of inflammatory (C-reactive protein) changes and were associated with both acute and sustained improvements in symptoms in the TRD group. Ketamine thus normalized fronto-striatal connectivity in TRD participants but disrupted it in HVs independently of inflammatory processes. These findings highlight the potential importance of reward circuitry in ketamine's mechanism of action, which may be particularly relevant for understanding ketamine-induced shifts in motivational symptoms.",2021,Ketamine increased fronto-striatal functional connectivity in TRD participants toward levels observed in HVs while shifting the connectivity profile in HVs toward a state similar to TRD participants under placebo.,"['33 individuals with treatment-resistant major depressive disorder (TRD) and 25 healthy volunteers (HVs', 'TRD participants', 'depressed and healthy individuals', 'healthy individuals']","['Resting-state functional magnetic resonance imaging (rsfMRI', 'Ketamine', 'placebo (final sample: TRD n\u2009=\u200925, HV n\u2009=\u200918) infusions and was used to probe fronto-striatal circuitry with striatal seed-based functional connectivity', 'ketamine', 'placebo']",['fronto-striatal functional connectivity'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}]",33.0,0.119014,Ketamine increased fronto-striatal functional connectivity in TRD participants toward levels observed in HVs while shifting the connectivity profile in HVs toward a state similar to TRD participants under placebo.,"[{'ForeName': 'Anahit', 'Initials': 'A', 'LastName': 'Mkrtchian', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. anahit.mkrtchian@nih.gov.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Evans', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Peixiong', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Roiser', 'Affiliation': 'Neuroscience and Mental Health Group, Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Molecular psychiatry,['10.1038/s41380-020-00878-1']
236,32864754,"Phase I safety, tolerability, and pharmacokinetic studies of tetramethylpyrazine nitrone in healthy Chinese volunteers.","BACKGROUND


The purpose of this study was to investigate the safety, tolerability and pharmacokinetics of tetramethylpyrazine nitrone (TBN) in healthy Chinese volunteers.
METHODS


A single-ascending-dose (SAD) study where 68 subjects were randomized to a single dose of placebo or TBN (50, 100, 200, 400, 700, 1,000, 1,400, or 1,800 mg) through IV infusion over 30 min. A multiple-ascending-dose (MAD) study where 24 subjects received TBN twice daily (with 12 hr interval) for total 6.5 days at doses of either 700 or 1,400 mg. Adverse events were recorded and pharmacokinetic samples were collected during the whole study period.
RESULTS


No serious adverse events were found in the study. All of the observed adverse events, including increased white blood cell (4.4% subjects) and neutrophil counts (4.4% subjects), and decreased hemoglobin levels (4.2% subjects), were laboratory test abnormalities. All the adverse events were mild and tolerable, and returned to normal without any intervention. In the SAD study, linear C max  values were observed in the dose interval of 50-1,800 mg. In the MAD study, the average steady-state concentrations (C avg.ss  ) of TBN in the 700 and 1,400 mg dose group were 2,407 and 5,837 ng/ml, respectively. No drug accumulation was observed in this study.
CONCLUSIONS


TBN is well tolerated in healthy volunteers. Linear C max  values were observed in the interval of 50-1,800 mg, and target exposures of TBN were achieved without accumulation after twice daily administration to subjects. (This study has been registered at ChiCTR.org.cn. Identifier: ChiCTR1800016225 and ChiCTR1800019627.).",2021,"All of the observed adverse events, including increased white blood cell (4.4% subjects) and neutrophil counts (4.4% subjects), and decreased hemoglobin levels (4.2% subjects), were laboratory test abnormalities.","['healthy Chinese volunteers', '68 subjects', 'healthy volunteers']","['tetramethylpyrazine nitrone (TBN', 'placebo or TBN', 'TBN', 'tetramethylpyrazine nitrone']","['neutrophil counts', 'hemoglobin levels', 'linear C max  values', 'drug accumulation', 'safety, tolerability and pharmacokinetics', 'Adverse events', 'average steady-state concentrations', 'Linear C max  values', 'white blood cell', 'serious adverse events']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C5198319', 'cui_str': 'tetramethylpyrazine nitrone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]",68.0,0.0516908,"All of the observed adverse events, including increased white blood cell (4.4% subjects) and neutrophil counts (4.4% subjects), and decreased hemoglobin levels (4.2% subjects), were laboratory test abnormalities.","[{'ForeName': 'Caiyun', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Institute of Clinical Pharmacology, The Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Institute of Clinical Pharmacology, The Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'Institute of Clinical Pharmacology, The Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Institute of Clinical Pharmacology, The Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Minji', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'Institute of Clinical Pharmacology, The Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yahong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Institute of Clinical Pharmacology, The Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Institute of Clinical Pharmacology, The Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Institute of Clinical Pharmacology, The Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Clinical Pharmacology, The Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Institute of Clinical Pharmacology, The Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Institute of Clinical Pharmacology, The Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Institute of Clinical Pharmacology, The Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yatai', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Institute of Clinical Pharmacology, The Peking University First Hospital, Beijing, China.'}]",Drug development research,['10.1002/ddr.21733']
237,32927371,Neural affective mechanisms associated with treatment responsiveness in veterans with PTSD and comorbid alcohol use disorder.,"Post-traumatic stress disorder (PTSD) is associated with neuro-physiological abnormalities reflecting increased anticipatory anxiety and reactivity to traumatic cues. It remains unclear whether neural mechanisms associated with PTSD treatment responsiveness, i.e. hyperactivation of the affective salience network in the brain, extend to a comorbid PTSD and substance use disorder population. Thirty-one Veterans with PTSD and co-occurring alcohol use disorder (AUD) were randomly assigned to either prolonged exposure or a non-exposure based treatment. They completed an affective anticipation task while undergoing fMRI, immediately prior and after completing treatment. After controlling for type and length of treatment, larger reduction of PTSD symptoms was associated with decreased anticipatory activation to negative trauma-related cues in the right pre-Supplementary Motor Area (pre-SMA), a region associated with emotion regulation. Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region. Our findings suggest that post-treatment reductions in anticipatory reactivity to trauma-related cues in the pre-SMA and para-hippocampal area are associated with larger PTSD symptom reduction in individuals with co-occurring PTSD and AUD. These results may offer neurofeedback training targets as an alternative to or enhancement of other PTSD treatment modalities in this population.",2020,"Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region.","['veterans with PTSD and comorbid alcohol use disorder', 'Thirty-one Veterans with PTSD and co-occurring alcohol use disorder (AUD', 'Post-traumatic stress disorder (PTSD']",['prolonged exposure or a non-exposure based treatment'],"['PTSD symptoms', 'PTSD severity']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",31.0,0.00943451,"Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region.","[{'ForeName': 'Katia M', 'Initials': 'KM', 'LastName': 'Harlé', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States. Electronic address: kharle@ucsd.edu.'}, {'ForeName': 'Alan N', 'Initials': 'AN', 'LastName': 'Simmons', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Andrea D', 'Initials': 'AD', 'LastName': 'Spadoni', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111172']
238,32935561,Demonstrating the Clinical Impact of Continuous Glucose Monitoring Within an Integrated Healthcare Delivery System.,"BACKGROUND


Approximately 30 million Americans currently suffer from diabetes, and nearly 55 million people will be impacted by 2030. Continuous glucose monitoring (CGM) systems help patients manage their care with real-time data. Although approximately 95% of those with diabetes suffer from type 2, few studies have measured CGM's clinical impact for this segment within an integrated healthcare system.
METHODS


A parallel randomized, multisite prospective trial was conducted using a new CGM device (Dexcom G6) compared to a standard of care finger stick glucometer (FSG) (Contour Next One). All participants received usual care in primary care clinics for six consecutive months while using these devices. Data were collected via electronic medical records, device outputs, exit surveys, and insurance company (SelectHealth) claims in accordance with institutional review board approval.
RESULTS


Ninety-nine patients were randomized for analysis ( n  = 50 CGM and  n  = 49 FSG). CGM patients significantly decreased hemoglobin A1c ( p  = .001), total visits ( p  = .009), emergency department encounters ( p  = .018), and labs ordered ( p  = .001). Among SelectHealth non-Medicare Advantage patients, per member per month savings were $417 for CGM compared to FSG, but $9 more for Medicare Advantage. Seventy percent of CGM users reported that the technology helped them better understand daily activity and diet compared to only 16% for FSG.
DISCUSSION


Participants using CGM devices had meaningful improvements in clinical outcomes, costs, and self-reported measures compared to the FSG group. Although a larger study is necessary to confirm these results, CGM devices appear to improve patient outcomes while making treatment more affordable.",2022,CGM patients significantly decreased hemoglobin A1c ( p  = .001),"['Ninety-nine patients', 'patients manage their care with real-time data', 'Approximately 30 million Americans currently suffer from diabetes, and nearly 55 million people']","['Continuous glucose monitoring (CGM) systems', 'standard of care finger stick glucometer (FSG) (Contour Next One', 'new CGM device (Dexcom G6', 'usual care', 'CGM']","['clinical outcomes, costs, and self-reported measures', 'total visits', 'emergency department encounters', 'hemoglobin A1c']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0457575', 'cui_str': 'Finger stick'}, {'cui': 'C0472226', 'cui_str': 'Blood glucose meters'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",99.0,0.040369,CGM patients significantly decreased hemoglobin A1c ( p  = .001),"[{'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Isaacson', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kaufusi', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Sorensen', 'Affiliation': 'Nublu, Salt Lake City, UT, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Joy', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Ingram', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Nickolas', 'Initials': 'N', 'LastName': 'Mark', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Phillips', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Briesacher', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}]",Journal of diabetes science and technology,['10.1177/1932296820955228']
239,32940857,"Project STRONG: an Online, Parent-Son Intervention for the Prevention of Dating Violence among Early Adolescent Boys.","Despite broad calls for prevention programs to reduce adolescent dating violence (DV), there is a dearth of programs designed specifically for males. In fact, there are no programs that capitalize on the importance of parents in modeling and influencing the choices their sons make in future romantic relationships. To address these gaps, this study assessed the initial feasibility, acceptability, and efficacy of an online, parent-son intervention (STRONG) aimed at reducing DV among early adolescent males. One-hundred nineteen 7th- and 8th-grade boys were recruited, with a parent (90% mothers), from six urban middle schools in the Providence, RI area. Dyads were randomized to either STRONG or a waitlist comparison group. STRONG targets three primary constructs: relationship health knowledge, emotion regulation, and communication. Families randomized to the waitlist were nearly twice as likely at 3 months (OR = 1.92 [0.43-8.60]) and nearly 7 times as likely at 9 months (OR = 6.76 [0.66-69.59]) to endorse any form of DV perpetration (physical, sexual, verbal/emotional) when compared with STRONG families. STRONG also had positive effects on teens' attitudes toward dealing with DV, their emotional awareness, and their short-term regulation skills and was associated with increased discussion of critical relationship topics. Pilot outcomes indicate that an online DV prevention program designed to engage early adolescent boys and parents is both acceptable and engaging. Findings show promise for reducing DV behaviors and theory-driven mediators. ClinicalTrials.gov Identifier: NCT03109184.",2021,"Families randomized to the waitlist were nearly twice as likely at 3 months (OR = 1.92 [0.43-8.60]) and nearly 7 times as likely at 9 months (OR = 6.76 [0.66-69.59]) to endorse any form of DV perpetration (physical, sexual, verbal/emotional) when compared with STRONG families.","['One-hundred nineteen 7th- and 8th-grade boys were recruited, with a parent (90% mothers), from six urban middle schools in the Providence, RI area', 'Early Adolescent Boys', 'early adolescent males']","['Online, Parent-Son Intervention', 'online DV prevention program']","['relationship health knowledge, emotion regulation, and communication', 'initial feasibility, acceptability, and efficacy', 'DV behaviors']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0037683', 'cui_str': 'Son'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4046106', 'cui_str': 'Dating Violence'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4046106', 'cui_str': 'Dating Violence'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0280442,"Families randomized to the waitlist were nearly twice as likely at 3 months (OR = 1.92 [0.43-8.60]) and nearly 7 times as likely at 9 months (OR = 6.76 [0.66-69.59]) to endorse any form of DV perpetration (physical, sexual, verbal/emotional) when compared with STRONG families.","[{'ForeName': 'Christie J', 'Initials': 'CJ', 'LastName': 'Rizzo', 'Affiliation': 'Department of Applied Psychology, Bouvé College of Health Sciences, Northeastern University, 432 INV, 360 Huntington Ave., Boston, MA, 02115-5000, USA. c.rizzo@northeastern.edu.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Houck', 'Affiliation': ""Bradley/Hasbro Children's Research Center/Rhode Island Hospital, Providence, RI, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Barker', 'Affiliation': ""Bradley/Hasbro Children's Research Center/Rhode Island Hospital, Providence, RI, USA.""}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Collibee', 'Affiliation': ""Bradley/Hasbro Children's Research Center/Rhode Island Hospital, Providence, RI, USA.""}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hood', 'Affiliation': 'Department of Applied Psychology, Bouvé College of Health Sciences, Northeastern University, 432 INV, 360 Huntington Ave., Boston, MA, 02115-5000, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Bala', 'Affiliation': ""Bradley/Hasbro Children's Research Center/Rhode Island Hospital, Providence, RI, USA.""}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01168-6']
240,32940718,The additional role of virtual to traditional dissection in teaching anatomy: a randomised controlled trial.,"INTRODUCTION


Anatomy has traditionally been taught via dissection and didactic lectures. The rising prevalence of informatics plays an increasingly important role in medical education. It is hypothesized that virtual dissection can express added value to the traditional one.
METHODS


Second-year medical students were randomised to study anatomical structures by virtual dissection (intervention) or textbooks (controls), according to the CONSORT guidelines. Subsequently, they applied to the corresponding gross dissection, with a final test on their anatomical knowledge. Univariate analysis and multivariable binary logistic regression were performed.
RESULTS


The rate of completed tests was 76.7%. Better overall test performance was detected for the group that applied to the virtual dissection (OR 3.75 with 95% CI 0.91-15.49; p = 0.06). A comparable performance between groups in basic anatomical knowledge (p 0.45 to 0.92) but not muscles and 2D-3D reporting of anatomical structures was found, for which the virtual dissection was of tendential benefit (p 0.08 to 0.13). Medical students who applied to the virtual dissection were over three times more likely to report a positive outcome at the post-dissection test than those who applied to textbooks of topographical anatomy. This would be of benefit with particular reference to the understanding of 2D-3D spatial relationships between anatomical structures.
CONCLUSION


The combination of virtual to traditional gross dissection resulted in a significant improvement of second-year medical students' learning outcomes. It could be of help in maximizing the impact of practical dissection, overcoming the contraction of economic resources, and the shortage of available bodies.",2021,"A comparable performance between groups in basic anatomical knowledge (p 0.45 to 0.92) but not muscles and 2D-3D reporting of anatomical structures was found, for which the virtual dissection was of tendential benefit (p 0.08 to 0.13).",['Second-year medical students'],"['virtual dissection (intervention) or textbooks (controls), according to the CONSORT guidelines']",['Better overall test performance'],"[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0266685,"A comparable performance between groups in basic anatomical knowledge (p 0.45 to 0.92) but not muscles and 2D-3D reporting of anatomical structures was found, for which the virtual dissection was of tendential benefit (p 0.08 to 0.13).","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Boscolo-Berto', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Tortorella', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Porzionato', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Stecco', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy.'}, {'ForeName': 'Edgardo Enrico Edoardo', 'Initials': 'EEE', 'LastName': 'Picardi', 'Affiliation': 'Digestive System Surgery Division, European Institute of Oncology (IRCSS), Via Ripamonti 435, Milano, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Macchi', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy. veronica.macchi@unipd.it.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caro', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy.'}]",Surgical and radiologic anatomy : SRA,['10.1007/s00276-020-02551-2']
241,33063203,Association Between Statins and Cancer Incidence in Diabetes: a Cohort Study of Japanese Patients with Type 2 Diabetes.,"BACKGROUND


The antitumor effect of statins has been highlighted, but clinical study results remain inconclusive. While patients with diabetes are at high risk of cancer, it is uncertain whether statins are effective for cancer chemoprevention in this population.
OBJECTIVE


This study evaluated the association between statins and cancer incidence/mortality in patients with type 2 diabetes.
DESIGN


This study was a follow-up observational study of the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD) trial, which was a randomized controlled trial of low-dose aspirin in Japanese patients with type 2 diabetes.
PARTICIPANTS


This study enrolled 2536 patients with type 2 diabetes, age 30-85 years, and no history of atherosclerotic cardiovascular disease, from December 2002 until May 2005. All participants recruited in the JPAD trial were followed until the day of any fatal event or July 2015. We defined participants taking any statin at enrollment as the statin group (n = 650) and the remainder as the no-statin group (n = 1886).
MAIN MEASURES


The primary end point was the first occurrence of any cancer (cancer incidence). The secondary end point was death from any cancer (cancer mortality).
KEY RESULTS


During follow-up (median, 10.7 years), 318 participants developed a new cancer and 123 died as a result. Cancer incidence and mortality were 10.5 and 3.7 per 1000 person-years in the statin group, and 16.8 and 6.3 per 1000 person-years in the no-statin group, respectively. Statin use was associated with significantly reduced cancer incidence and mortality after adjustment for confounding factors (cancer incidence: adjusted hazard ratio [HR], 0.67; 95% CI, 0.49-0.90, P = 0.007; cancer mortality: adjusted HR, 0.60; 95% CI, 0.36-0.98, P = 0.04).
CONCLUSIONS


Statin use was associated with a reduced incidence and mortality of cancer in Japanese patients with type 2 diabetes.",2021,"Statin use was associated with significantly reduced cancer incidence and mortality after adjustment for confounding factors (cancer incidence: adjusted hazard ratio [HR], 0.67; 95% CI, 0.49-0.90, P = 0.007; cancer mortality: adjusted HR, 0.60; 95% CI, 0.36-0.98, P = 0.04).
","['participants taking any statin at enrollment as the statin group (n\u2009=\u2009650) and the remainder as the no-statin group (n\u2009=\u20091886', 'Diabetes', 'patients with type 2 diabetes', 'Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD', 'Japanese patients with type 2 diabetes', '2536 patients with type 2 diabetes, age 30-85\xa0years, and no history of atherosclerotic cardiovascular disease, from December 2002 until May 2005', 'All participants recruited in the JPAD trial were followed until the day of any fatal event or July 2015', '318 participants developed a new cancer and 123 died as a result', 'Japanese Patients with Type 2 Diabetes']",['aspirin'],"['death from any cancer (cancer mortality', 'cancer incidence and mortality', 'Cancer incidence and mortality', 'incidence and mortality of cancer', 'first occurrence of any cancer (cancer incidence']","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",2536.0,0.052467,"Statin use was associated with significantly reduced cancer incidence and mortality after adjustment for confounding factors (cancer incidence: adjusted hazard ratio [HR], 0.67; 95% CI, 0.49-0.90, P = 0.007; cancer mortality: adjusted HR, 0.60; 95% CI, 0.36-0.98, P = 0.04).
","[{'ForeName': 'Sadanori', 'Initials': 'S', 'LastName': 'Okada', 'Affiliation': 'Center for Postgraduate Training, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Soejima', 'Affiliation': 'Department of Cardiology, Graduate School of Medical Science, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Center for Health Surveillance & Preventive Medicine, Tokyo Medical University Hospital, Tokyo, Japan.'}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Nakayama Cardiovascular Clinic, Kumamoto, Japan.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Doi', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Prefectural Seiwa Medical Center, Nara, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Department of Internal Medicine, Jinnouchi Hospital Diabetes Care Center, Kumamoto, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Waki', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Metabolism, Shizuoka City Shizuoka Hospital, Shizuoka, Japan.'}, {'ForeName': 'Izuru', 'Initials': 'I', 'LastName': 'Masuda', 'Affiliation': 'Medical Examination Center, Takeda Hospital, Kyoto, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Medical University, 840 Shijo, Kashihara, Nara, 634-8522, Japan. saitonaramed@gmail.com.'}]",Journal of general internal medicine,['10.1007/s11606-020-06167-5']
242,32989597,A 12-month follow-up of primary and secondary root canal treatment in teeth obturated with a hydraulic sealer.,"OBJECTIVES


This randomized, controlled, pilot study assessed the outcome of non-surgical primary/secondary root canal treatments either with a novel bioactive sealer and the single-cone technique or with gutta-percha, zinc oxide-eugenol sealer (ZOE), and warm vertical compaction.
MATERIALS AND METHODS


Sixty-nine patients were randomly divided into two groups that were treated using the single-cone technique with BioRoot TM  RCS (Septodont) (BIO group) or warm vertical compaction with gutta-percha and ZOE sealer (PCS group). Two subsamples (BIOAP and PCSAP) comprised the cases with apical periodontitis. Treatment was undertaken by four residents using a standardized instrumentation and disinfection protocol. The periapical index (PAI) was recorded, and clinical and radiographic follow-up performed at 1, 3, 6, and 12 months. Treatment success was assessed according to ""periapical healing"" and ""tooth survival"". The test for the equality of proportions, t tests for the equality of means, and non-parametric K-sample tests for the equality of medians were applied when appropriate.
RESULTS


The survival rate was similar in the BIO and PCS (p = 0.4074) and the BIOAP and PCSAP groups (p = 0.9114). The success rate was higher in the BIO groups, but not statistically significant (p = 0.0735). In both BIOAP and PCSAP groups, a progressive decrease in the PAI was observed.
CONCLUSION


At 12 months, both techniques showed reliable results. Further studies and longer follow-ups are needed.
CLINICAL RELEVANCE


This study documents the feasibility of using a bioactive sealer in conjunction with the single-cone technique to obturate the root canal and obtaining a predictable outcome.
TRIAL REGISTRATION


ClinicalTrials.gov Identifie: NCT04249206.",2021,The survival rate was similar in the BIO and PCS (p = 0.4074) and the BIOAP and PCSAP groups (p = 0.9114).,['Sixty-nine patients'],"['single-cone technique with BioRoot TM  RCS (Septodont) (BIO group) or warm vertical compaction with gutta-percha and ZOE sealer (PCS group', 'bioactive sealer', 'novel bioactive sealer and the single-cone technique or with gutta-percha, zinc oxide-eugenol sealer (ZOE), and warm vertical compaction']","['periapical index (PAI', 'success rate', 'periapical healing"" and ""tooth survival', 'survival rate', 'PAI']","[{'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0206428', 'cui_str': 'Cone of retina'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0043492', 'cui_str': 'Zinc oxide eugenol dental cement'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032145', 'cui_str': 'Plasminogen activator inhibitor'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",69.0,0.034463,The survival rate was similar in the BIO and PCS (p = 0.4074) and the BIOAP and PCSAP groups (p = 0.9114).,"[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Bardini', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, University of Cagliari, Cagliari, Italy. supergiu.gb@gmail.com.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Casula', 'Affiliation': 'Department of Medicine and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Ambu', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Musu', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Mercadè', 'Affiliation': 'Department of Dentistry, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Cotti', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, University of Cagliari, Cagliari, Italy.'}]",Clinical oral investigations,['10.1007/s00784-020-03590-0']
243,33004239,"DAR-901 vaccine for the prevention of infection with Mycobacterium tuberculosis among BCG-immunized adolescents in Tanzania: A randomized controlled, double-blind phase 2b trial.","BACKGROUND


SRL172 prevented disease due to Mycobacterium tuberculosis in a Phase 3 trial. DAR-901 represents a scalable manufacturing process for SRL172. We sought to determine if DAR-901 would prevent infection with M. tuberculosis among BCG-primed adolescents age 13-15 years in Tanzania.
METHODS


Adolescents with a negative T- SPOT.TB R  interferon gamma release assay (IGRA) were randomized 1:1 to three intradermal injections of DAR-901 or saline placebo at 0, 2 and 4 months. Repeat IGRAs were performed at 2 months, and at 1, 2, and 3 years. The primary efficacy outcome was time to new TB infection (IGRA conversion to positive); the secondary outcome was time to persistent TB infection (IGRA conversion with repeat positive IGRA).
RESULTS


Among 936 participants screened 667 were eligible and randomized to their first dose of vaccine or placebo (safety cohort). At 2 months, 625 participants remained IGRA-negative and were scheduled for the additional two doses (efficacy cohort). DAR-901 was safe and well-tolerated. One DAR-901 recipient developed a vaccine site abscess. Neither the primary nor secondary endpoints differed between the two treatment arms (p = 0.90 and p = 0.20, respectively). DAR-901 IGRA converters had median responses to ESAT-6 of 50.1 spot-forming cells (SFCs) vs. 19.6 SFCs in placebo IGRA converters (p = 0.03).
CONCLUSIONS


A three-dose series of 1 mg DAR-901 was safe and well-tolerated but did not prevent initial or persistent IGRA conversion. DAR-901 recipients with IGRA conversion demonstrated enhanced immune responses to ESAT-6. Since protection against disease may require different immunologic responses than protection against infection a trial of DAR-901 to prevent TB disease is warranted.
TRIAL REGISTRATION


The trial is registered at ClinicalTrials.gov as NCT02712424.",2020,"Neither the primary nor secondary endpoints differed between the two treatment arms (p = 0.90 and p = 0.20, respectively).","['BCG-immunized adolescents in Tanzania', '936 participants screened 667 were eligible and randomized to their first dose of', 'Adolescents with a negative T- SPOT.TB R  interferon gamma release assay (IGRA', 'BCG-primed adolescents age 13-15\xa0years in Tanzania', '625 participants remained IGRA-negative']","['DAR-901 or saline placebo', 'vaccine or placebo', 'IGRA', 'DAR-901', 'DAR-901 vaccine']","['safe and well-tolerated', 'time to new TB infection (IGRA conversion to positive); the secondary outcome was time to persistent TB infection (IGRA conversion with repeat positive IGRA']","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517851', 'cui_str': '667'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3178802', 'cui_str': 'Interferon gamma release assay'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517838', 'cui_str': '625'}]","[{'cui': 'C0022595', 'cui_str': 'Darier disease'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3178802', 'cui_str': 'Interferon gamma release assay'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C3178802', 'cui_str': 'Interferon gamma release assay'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",,0.588273,"Neither the primary nor secondary endpoints differed between the two treatment arms (p = 0.90 and p = 0.20, respectively).","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Munseri', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Jamila', 'Initials': 'J', 'LastName': 'Said', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Amour', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Magohe', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Mecky', 'Initials': 'M', 'LastName': 'Matee', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Christiaan A', 'Initials': 'CA', 'LastName': 'Rees', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Mackenzie', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Tvaroha', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bailey-Kellogg', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Maro', 'Affiliation': 'Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Wieland-Alter', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Lisa V', 'Initials': 'LV', 'LastName': 'Adams', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'C Robert', 'Initials': 'CR', 'LastName': 'Horsburgh', 'Affiliation': 'Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Arbeit', 'Affiliation': 'Tufts University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Kisali', 'Initials': 'K', 'LastName': 'Pallangyo', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'C Fordham', 'Initials': 'CF', 'LastName': 'von Reyn', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA. Electronic address: fvr@dartmouth.edu.'}]",Vaccine,['10.1016/j.vaccine.2020.09.055']
244,32996592,"Local Transdermal Delivery of Telapristone Acetate Through Breast Skin, Compared With Oral Treatment: A Randomized Double-Blind, Placebo-Controlled Phase II Trial.","Oral breast cancer prevention medications entail systemic exposure, limiting acceptance by high-risk women. Delivery through the breast skin, although an attractive alternative, requires demonstration of drug distribution throughout the breast. We conducted a randomized double-blind, placebo-controlled phase II clinical trial comparing telapristone acetate, a progesterone receptor antagonist, administered orally (12 mg/day) or transdermally (12 mg/breast) for 4 ± 1 weeks to women planning mastectomy. Plasma and tissue concentrations, measured at five locations in the mastectomy specimen using liquid chromatography tandem mass spectrometry were compared. In 60 evaluable subjects, median drug concentration (ng/g tissue) was 103 (interquartile range (IQR): 46.3-336) in the oral vs. 2.82 (IQR: 1.4-5.5) in the transdermal group. Despite poor dermal permeation, within-breast drug distribution pattern was identical in both groups (R 2   = 0.88, P = 0.006), demonstrating that transdermally and orally delivered drug is distributed similarly through the breast, and is strongly influenced by tissue adiposity (P < 0.0001). Other skin-penetrant drugs should be tested for breast cancer prevention.",2021,"Despite poor dermal permeation, within-breast drug distribution pattern was identical in both groups (R 2  =0.88, p=0.006), demonstrating that transdermally and orally delivered drug is distributed similarly through the breast, and is strongly influenced by tissue adiposity (p<0.0001).","['60 evaluable subjects, median drug concentration (ng/g tissue) was 103 (IQR: 46.3-336) in the oral vs 2.82 (IQR: 1.4-5.5) in the transdermal group', 'high risk women']","['placebo', 'telapristone acetate', 'telapristone acetate (TPA), a progesterone receptor (PR) antagonist']",['Plasma and tissue concentrations'],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1627892', 'cui_str': 'ug/kg'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C2745478', 'cui_str': 'AM103'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3501648', 'cui_str': 'telapristone acetate'}, {'cui': 'C0034833', 'cui_str': 'Progesterone receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.134135,"Despite poor dermal permeation, within-breast drug distribution pattern was identical in both groups (R 2  =0.88, p=0.006), demonstrating that transdermally and orally delivered drug is distributed similarly through the breast, and is strongly influenced by tissue adiposity (p<0.0001).","[{'ForeName': 'Oukseub', 'Initials': 'O', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pilewskie', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Karlan', 'Affiliation': 'Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Tull', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Benante', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Yanfei', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Blanco', 'Affiliation': 'Department of Pathology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Helenowski', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Masha', 'Initials': 'M', 'LastName': 'Kocherginsky', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Shivangi', 'Initials': 'S', 'LastName': 'Yadav', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hosseini', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Hansen', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bethke', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Muzzio', 'Affiliation': 'Analytical Chemistry Division, Illinois Institute of Technology Research Institute, Chicago, Illinois, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Troester', 'Affiliation': 'Department of Epidemiology, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Dimond', 'Affiliation': 'National Cancer Institute Division of Cancer Prevention, Bethesda, Maryland, USA.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Perloff', 'Affiliation': 'National Cancer Institute Division of Cancer Prevention, Bethesda, Maryland, USA.'}, {'ForeName': 'Brandy', 'Initials': 'B', 'LastName': 'Heckman-Stoddard', 'Affiliation': 'National Cancer Institute Division of Cancer Prevention, Bethesda, Maryland, USA.'}, {'ForeName': 'Seema A', 'Initials': 'SA', 'LastName': 'Khan', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2041']
245,33044756,"Improvement of Functioning and Health With Ixekizumab in the Treatment of Active Nonradiographic Axial Spondyloarthritis in a 52-Week, Randomized, Controlled Trial.","OBJECTIVE


To evaluate the effect of ixekizumab on self-reported functioning and health in patients with active nonradiographic axial spondyloarthritis (SpA).
METHODS


COAST-X was a randomized, controlled trial conducted in patients with nonradiographic axial SpA over 52 weeks. Participants were randomized at a ratio of 1:1:1 to receive 80 mg of ixekizumab subcutaneously every 4 weeks or 2 weeks or placebo for 52 weeks. Self-reported functioning and health end points included the Medical Outcomes Study Short Form 36 (SF-36) health survey, Assessment of Spondyloarthritis International Society (ASAS) health index, and European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) health-utility descriptive system.
RESULTS


Compared to placebo, ixekizumab treatment resulted in improvement of SF-36 physical component summary scores from baseline, with a score of 4.7 improving to 8.9 with ixekizumab therapy every 4 weeks (P < 0.05) and a score of 9.3 with ixekizumab therapy every 2 weeks (P < 0.01); the greatest improvements were observed in the domains of physical functioning, role-physical, and bodily pain at weeks 16 and 52. A higher proportion of patients receiving ixekizumab therapy every 2 weeks reported ≥3 improvements based on the ASAS health index from baseline to weeks 16 and 52 (P < 0.05). Significantly more patients receiving ixekizumab every 4 weeks reported improvements in ""good health status"" on the ASAS health index (ASAS score of ≤5) at weeks 16 and 52 (P < 0.05). Patients receiving ixekizumab reported improvements on the EQ-5D-5L compared to those who received placebo at week 16 (0.11 versus 0.17 for patients receiving treatment every 4 weeks and 0.19 for patients receiving treatment every 2 weeks; P < 0.05), which remained consistent at week 52. There were no clinical meaningful differences in responses based on the ixekizumab dosing regimen for patients who received ixekizumab therapy every 2 weeks or every 4 weeks.
CONCLUSION


In patients with nonradiographic axial SpA, therapy with ixekizumab was superior to placebo in the improvement of self-reported functioning and health at weeks 16 and 52.",2022,"Compared with placebo, ixekizumab treatment improved SF-36 Physical Component Summary scores from baseline (4.7 versus 8.9 IXE Q4W, p<0.05, 9.3 IXE Q2W, p<0.01), with greatest improvements observed in Physical Functioning, Role-physical and Bodily Pain domains at Weeks 16 and 52.","['patients with nr-axSpA of 52-weeks duration', 'patients with active non-radiographic axial spondyloarthritis (nr-axSpA']","['Ixekizumab', 'placebo, ixekizumab', 'placebo', 'ixekizumab', 'subcutaneous 80 mg ixekizumab']","['ASAS HI ""good health status', 'SF-36 Physical Component Summary scores', 'EQ-5D-5L', 'Medical Outcomes Study 36-Item Short Form Health Survey 36-item (SF-36), Assessment of SpondyloArthritis international Society Health Index (ASAS HI), and European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) health-utility', 'Physical Functioning, Role-physical and Bodily Pain domains']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3889038', 'cui_str': 'Non-radiographic axial spondyloarthritis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",,0.175143,"Compared with placebo, ixekizumab treatment improved SF-36 Physical Component Summary scores from baseline (4.7 versus 8.9 IXE Q4W, p<0.05, 9.3 IXE Q2W, p<0.01), with greatest improvements observed in Physical Functioning, Role-physical and Bodily Pain domains at Weeks 16 and 52.","[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Walsh', 'Affiliation': 'University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'Marina N', 'Initials': 'MN', 'LastName': 'Magrey', 'Affiliation': 'MetroHealth Medical Center and Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Ruhr-University Bochum, Bochum, Germany, and Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Inui', 'Affiliation': 'Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Meng-Yu', 'Initials': 'MY', 'LastName': 'Weng', 'Affiliation': 'National Cheng Kung University Medical College and Hospital, Tainan, Taiwan.'}, {'ForeName': 'Ennio', 'Initials': 'E', 'LastName': 'Lubrano', 'Affiliation': 'University of Molise, Campobasso, Italy.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Boonen', 'Affiliation': 'Maastricht University Medical Center and Caphri Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Lianne S', 'Initials': 'LS', 'LastName': 'Gensler', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'Ruhr-University Bochum, Bochum, Germany, and Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Hunter', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Baojin', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'León', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'David Marcelino Sandoval', 'Initials': 'DMS', 'LastName': 'Calderon', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Kiltz', 'Affiliation': 'Ruhr-University Bochum, Bochum, Germany, and Osaka City University Graduate School of Medicine, Osaka, Japan.'}]",Arthritis care & research,['10.1002/acr.24482']
246,32967605,"Self-Care Education Program as a New Pathway Toward Improving Quality of Life in Kidney Transplant Patients: A Single-Blind, Randomized, Controlled Trial.","OBJECTIVES


Despite the benefits of kidney transplant, kidney recipients are confronting many challenges that affect the quality of their lives. Implementation of the most effective self-care education program based on the needs of patients may address these challenges and improve their quality of life. This study aimed to determine the effects of a self-care education program on the quality of life in kidney transplant patients.
MATERIALS AND METHODS


In this single-blind, randomized, controlled trial, 59 patients who met inclusion criteria were selected using a convenience sampling technique. Patients were randomly allocated into intervention (n = 29) and control (n = 30) groups. The intervention group received a bedside self-care education program in 3 sessions. The control group only received routine care. Data were collected by demographic and kidney transplant questionnaires before and after the intervention. Measuring the mean score of quality of life was the primary outcome in this study. We used descriptive and inferential statistics to analyze the data.
RESULTS


A significant difference was observed in the mean score of quality of life between both groups after intervention (P < .001). The mean score of quality of life increased significantly in the intervention group after the self-care education program (P < .001).
CONCLUSIONS


A self-care education program is a more effective approach to improve the knowledge and skills of transplant patients. Thus, we suggest an emphasis on teaching self-care knowledge and skills for transplant patients in nursing care education programs. This can ultimately lead to quality of life improvement in kidney transplant patients.",2021,A significant difference was observed in the mean score of quality of life between both groups after intervention (P ⟨ .001).,"['kidney transplant patients', 'Kidney Transplant Patients', 'transplant patients', '59 patients who met inclusion criteria were selected using a convenience sampling technique', 'transplant patients in nursing care education programs']","['self-care education program', 'bedside self-care education program', 'routine care']","['Quality of Life', 'quality of life', 'mean score of quality of life']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",59.0,0.0337106,A significant difference was observed in the mean score of quality of life between both groups after intervention (P ⟨ .001).,"[{'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Aghakhani', 'Affiliation': 'From the Patient Safety Research Center, Nursing and Midwifery Faculty, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Masumeh Hemmati', 'Initials': 'MH', 'LastName': 'Maslakpak', 'Affiliation': ''}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Jalali', 'Affiliation': ''}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Parizad', 'Affiliation': ''}]",Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation,['10.6002/ect.2020.0044']
247,33236509,Results from the Effects of MEtformin on cardiovasculaR function in AdoLescents with type 1 Diabetes (EMERALD) study: A brief report of kidney and inflammatory outcomes.,"Youth with type 1 diabetes (T1D) demonstrate insulin resistance, independently of glycaemia, when compared to normoglycaemic peers. Insulin resistance increases the risk of cardiovascular disease and diabetic kidney disease, factors also associated with systemic inflammation. We evaluated the effect of metformin on markers of inflammation and diabetic kidney disease in adolescents with T1D. EMERALD, a double-blind, randomized, placebo-controlled trial of 3 months of metformin in 48 participants aged 12-21 years with T1D, included baseline and follow-up assessments of serum creatinine and cystatin C to estimate glomerular filtration rate (eGFR), aspartate aminotransferase, alanine aminotransferase, high-sensitivity C-reactive protein, white blood count, platelets, adiponectin, leptin, and urine albumin: creatinine ratio (UACR). Metformin was associated with a 13.9 mL/min/1.73 m 2  (95% confidence interval 4.7-23.1 mL/min/1.73 m 2  ) increase in estimated GFR by serum creatinine versus placebo (P ≤ 0.01), with a significant difference remaining after multivariable adjustments (P = 0.03). Whereas eGFR measured by serum creatinine increased significantly after metformin treatment, no differences were observed in cystatin C, UACR, or systemic inflammatory markers. Additional studies with directly measured GFR in response to metformin in T1D are needed.",2021,"Whereas eGFR measured by serum creatinine increased significantly following metformin, no differences were observed with cystatin C, UACR, or systemic inflammatory markers.","['Youth with type 1 diabetes (T1D', 'AdoLescents with Type 1 Diabetes', '48 youth aged 12-21\u2009years with T1D, included baseline and follow-up assessments of']","['metformin', 'MEtformin', 'Metformin', 'placebo']","['eGFR measured by serum creatinine', 'eGFR by serum creatinine', 'CardiovasculaR Function', 'cystatin C, UACR, or systemic inflammatory markers', 'serum creatinine and cystatin C to estimate glomerular filtration rate (eGFR), AST, ALT, highly sensitive c-reactive protein, white blood count, platelets, adiponectin, leptin, and urine albumin:creatinine ratio (UACR', 'risk for cardiovascular disease (CVD) and diabetic kidney disease (DKD']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439822', 'cui_str': 'Highly sensitive'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}]",,0.154029,"Whereas eGFR measured by serum creatinine increased significantly following metformin, no differences were observed with cystatin C, UACR, or systemic inflammatory markers.","[{'ForeName': 'Kalie L', 'Initials': 'KL', 'LastName': 'Tommerdahl', 'Affiliation': ""Department of Pediatrics, Section of Pediatric Endocrinology, Children's Hospital Colorado and University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.""}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Bjornstad', 'Affiliation': ""Department of Pediatrics, Section of Pediatric Endocrinology, Children's Hospital Colorado and University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kendrick', 'Affiliation': 'Department of Medicine, Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cree-Green', 'Affiliation': ""Department of Pediatrics, Section of Pediatric Endocrinology, Children's Hospital Colorado and University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.""}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Baumgartner', 'Affiliation': ""Department of Pediatrics, Section of Pediatric Endocrinology, Children's Hospital Colorado and University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pyle', 'Affiliation': ""Department of Pediatrics, Section of Pediatric Endocrinology, Children's Hospital Colorado and University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.""}, {'ForeName': 'Jane E B', 'Initials': 'JEB', 'LastName': 'Reusch', 'Affiliation': ""Center for Women's Health Research, Division of General Internal Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.""}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ""Department of Pediatrics, Section of Pediatric Endocrinology, Children's Hospital Colorado and University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14266']
248,33009245,"Effect of a brief scenario-tailored educational program on parents' risk knowledge, perceptions, and decisions to administer prescribed opioids: a randomized controlled trial.","ABSTRACT


This randomized, controlled trial evaluated whether a brief educational program (ie, Scenario-Tailored Opioid Messaging Program [STOMP]) would improve parental opioid risk knowledge, perceptions, and analgesic efficacy; ensure safe opioid use decisions; and impact prescription opioid use after surgery. Parent-child dyads (n = 604) who were prescribed an opioid for short-term use were randomized to routine instruction (Control) or routine plus STOMP administered preoperatively. Baseline and follow-up surveys assessed parents' awareness and perceived seriousness of adverse opioid effects, and their analgesic efficacy. Parents' decisions to give an opioid in hypothetical scenarios and total opioid doses they gave to children at home were assessed at follow-up. Scenario-Tailored Opioid Messaging Program parents gained enhanced perceptions of opioid-related risks over time, whereas Controls did not; however, risk perceptions did not differ between groups except for addiction risk. Scenario-Tailored Opioid Messaging Program parents exhibited marginally greater self-efficacy compared to Controls (mean difference vs controls = 0.58 [95% confidence interval 0.08-1.09], P = 0.023). Scenario-Tailored Opioid Messaging Program parents had a 53% lower odds of giving an opioid in an excessive sedation scenario (odds ratio 0.47 [95% confidence interval 0.28-0.78], P = 0.003), but otherwise made similar scenario-based opioid decisions. Scenario-Tailored Opioid Messaging Program was not associated with total opioid doses administered at home. Instead, parents' analgesic efficacy and pain-relief preferences explained 7%, whereas child and surgical factors explained 22% of the variance in opioid doses. Scenario-tailored education enhanced parents' opioid risk knowledge, perceptions, and scenario-based decision-making. Although this may inform later situation-specific decision-making, our research did not demonstrate an impact on total opioid dosing, which was primarily driven by surgical and child-related factors.",2021,"STOMP parents exhibited marginally greater self-efficacy compared to Controls (mean difference vs. controls=0.58 [95% CI 0.08, 1.09], p=.023).","['Parent-child dyads', 'n=604) who were prescribed an opioid for short-term use']","['routine instruction (Control) or routine plus STOMP', 'brief educational program (i.e., Scenario-Tailored Opioid Messaging Program [STOMP', 'brief scenario-tailored educational program']","[""parents' awareness and perceived seriousness of adverse opioid effects, and their analgesic efficacy"", 'excessive sedation scenario', 'risk perceptions', 'analgesic efficacy and pain-relief preferences', ""parents' risk knowledge, perceptions and decisions to administer prescribed opioids"", 'self-efficacy']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205404', 'cui_str': 'Serious'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",604.0,0.0613903,"STOMP parents exhibited marginally greater self-efficacy compared to Controls (mean difference vs. controls=0.58 [95% CI 0.08, 1.09], p=.023).","[{'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Voepel-Lewis', 'Affiliation': 'Department of Anesthesiology, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Malviya', 'Affiliation': 'Department of Anesthesiology, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Grant', 'Affiliation': 'Department of Orthopedic Surgery at the University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dwyer', 'Affiliation': 'Department of Anesthesiology, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Becher', 'Affiliation': 'Department of Anesthesiology, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Jacob H', 'Initials': 'JH', 'LastName': 'Schwartz', 'Affiliation': 'Department of Anesthesiology, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Tait', 'Affiliation': 'Department of Anesthesiology, University of Michigan, Ann Arbor, MI, United States.'}]",Pain,['10.1097/j.pain.0000000000002095']
249,33025146,Application of a surgical guide in the extraction of impacted mesiodentes: a randomized controlled trial.,"OBJECTIVE


To explore and evaluate the application of a surgical guide in the extraction of impacted mesiodentes.
MATERIALS AND METHODS


Patients with impacted mesiodentes approachable from the labial side of the maxilla were randomly divided into three groups. The surgical guide for group I was made using cone beam computed tomography (CBCT) and dental cast, whereas the surgical guide for group II was only made using CBCT data. Group I and group II were first evaluated to determine whether guide use could accurately locate the cementoenamel junction (CEJ) of the mesiodentes, and the impacted mesiodentes were extracted with the help of the surgical guide. Group III underwent an operation without a guide. For all patients, the preoperative design time, tooth searching time, operation time, complications, and costs were measured.
RESULTS


The guides for group I and group II could locate the CEJ of the mesiodentes accurately, with good application effect during the operation. Group I and group II required additional preoperative design time compared with group III. However, the tooth searching time and operation time in groups I and II were significantly reduced compared with those in group III. Group I and group II showed no intraoperative complications, and two cases in group III showed imprecision during localization. The overall cost for group III was higher than that of group I or group II. But group I and group II required extra visits and costs.
CONCLUSIONS


Despite some limitations, the surgical guide assisted with mesiodentes extraction and can improve the quality of the operation quality as well as reducing its economic burden, difficulty, and duration. Through proper design, we can create a high-quality surgical guide using only CBCT data.
CLINICAL RELEVANCE


The surgical guide can be used as an important assistive tool in alveolar surgery.",2021,"However, the tooth searching time and operation time in groups I and II were significantly reduced compared with those in group III.","['impacted mesiodentes', 'Patients with impacted mesiodentes approachable from the labial side of the maxilla']",[],"['tooth searching time and operation time', 'preoperative design time, tooth searching time, operation time, complications, and costs', 'overall cost', 'intraoperative complications']","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0266030', 'cui_str': 'Supernumerary mesiodens tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]",[],"[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}]",,0.0154595,"However, the tooth searching time and operation time in groups I and II were significantly reduced compared with those in group III.","[{'ForeName': 'Xianghuai', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Jianjiang', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Shuguang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jia', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""Center of Oral Implantology, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China. 654365980@qq.com.""}]",Clinical oral investigations,['10.1007/s00784-020-03620-x']
250,33046233,Ventricular reshaping with a beating heart implant improves pump function in experimental heart failure.,"OBJECTIVE


The left ventricle remodels from an ellipsoidal/conical shape to a spherical shape after a myocardial infarction. The spherical ventricle is inefficient as a pumping chamber, has higher wall stresses, and can lead to congestive heart failure. We sought to investigate if restoring physiological ventricular shape with a beating heart implant improves pump function.
METHODS


Rats were induced with a myocardial infarction, developing left ventricular dilatation and dysfunction, and becoming spherical over 3 weeks. Thereafter, they were randomized to undergo left ventricular reshaping with a beating heart implant (n = 19) or continue follow-up without an implant (n = 19). Biweekly echocardiography was performed until 12 weeks, with half the rats euthanized at 6 weeks and remaining at 12 weeks. At termination, invasive hemodynamic parameters and histopathology were performed.
RESULTS


At 3 weeks after the infarction, rats had a 22% fall in ejection fraction, 31% rise in end diastolic volume, and 23% rise in sphericity. Transventricular implant reshaping reduced the volume by 12.6% and sphericity by 21%, restoring physiologic ventricular shape and wall stress. Over the 12-week follow-up, pump function improved significantly with better ventricular-vascular coupling in the reshaped hearts. In this group, cardiomyocyte cross-section area was higher and the cells were less elongated.
CONCLUSIONS


Reshaping a postinfarction, failing left ventricle to restore its physiological conical shape significantly improves long-term pump function.",2020,"Over the 12-week follow-up, pump function improved significantly with better ventricular-vascular coupling in the reshaped hearts.","['experimental heart failure', 'Rats were induced with a myocardial infarction, developing left ventricular dilatation and dysfunction, and becoming spherical over 3 weeks']","['left ventricular reshaping with a beating heart implant (n\xa0=\xa019) or continue follow-up without an implant', 'Ventricular reshaping with a beating heart implant']","['sphericity', 'cardiomyocyte cross-section area', 'ejection fraction', 'restoring physiologic ventricular shape and wall stress', 'end diastolic volume']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0344911', 'cui_str': 'Left cardiac ventricular dilatation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0225828', 'cui_str': 'Cardiac myocyte'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0212346,"Over the 12-week follow-up, pump function improved significantly with better ventricular-vascular coupling in the reshaped hearts.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Onohara', 'Affiliation': 'Structural Heart Research & Innovation Laboratory, Carlyle Fraser Heart Center, Emory University Hospital Midtown, Atlanta, Ga.'}, {'ForeName': 'Daniella M', 'Initials': 'DM', 'LastName': 'Corporan', 'Affiliation': 'Structural Heart Research & Innovation Laboratory, Carlyle Fraser Heart Center, Emory University Hospital Midtown, Atlanta, Ga.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Kono', 'Affiliation': 'Structural Heart Research & Innovation Laboratory, Carlyle Fraser Heart Center, Emory University Hospital Midtown, Atlanta, Ga.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Joint Department of Biomedical Engineering, Emory University/Georgia Institute of Technology, Atlanta, Ga.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Guyton', 'Affiliation': 'Structural Heart Research & Innovation Laboratory, Carlyle Fraser Heart Center, Emory University Hospital Midtown, Atlanta, Ga; Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Ga.'}, {'ForeName': 'Muralidhar', 'Initials': 'M', 'LastName': 'Padala', 'Affiliation': 'Structural Heart Research & Innovation Laboratory, Carlyle Fraser Heart Center, Emory University Hospital Midtown, Atlanta, Ga; Joint Department of Biomedical Engineering, Emory University/Georgia Institute of Technology, Atlanta, Ga; Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Ga. Electronic address: spadala@emory.edu.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.08.097']
251,32950036,Efficacy of Circumferential Intensive Phototherapy in Treating Neonatal Hyperbilirubinemia: A Pilot Study.,"OBJECTIVE


The present study was aimed at developing a circumferential phototherapy unit using 3M reflective materials in the double-sided phototherapy unit and investigating its efficacy in treating neonatal hyperbilirubinemia.
STUDY DESIGN


Forty-two infants with neonatal hyperbilirubinemia were selected from our hospital; they were randomly divided into control ( n  = 21) and experimental groups ( n  = 21). The experimental group was treated with the circumferential phototherapy unit, while the control group was treated with an ordinary phototherapy unit.
RESULTS


No significant differences were noted between the two groups in the levels of transcutaneous bilirubin before phototherapy ( p  > 0.05). After 12 hours of phototherapy, the value of transcutaneous bilirubin decreased significantly in the experimental group compared with that of the control group ( p  < 0.05). Additionally, the two groups did not exhibit any significant difference in the side effects ( p  > 0.05).
CONCLUSION


Our results indicated that the circumferential phototherapy unit was more effective than the ordinary phototherapy unit in treating neonatal hyperbilirubinemia.
KEY POINTS


· A circumferential phototherapy unit was developed using 3M reflective materials.. · The circumferential phototherapy unit was more effective than the ordinary.. · The two groups did not exhibit any significant difference in the side effects..",2022,No significant differences were noted between the two groups in the levels of transcutaneous bilirubin before phototherapy ( p  > 0.05).,"['Forty-two infants with neonatal hyperbilirubinemia were selected from our hospital', 'Treating Neonatal Hyperbilirubinemia']","['Circumferential Intensive Phototherapy', 'circumferential phototherapy unit, while the control group was treated with an ordinary phototherapy unit']","['levels of transcutaneous bilirubin', 'value of transcutaneous bilirubin', 'side effects']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0857007', 'cui_str': 'Neonatal hyperbilirubinemia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0182261', 'cui_str': 'Phototherapy unit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",42.0,0.0149103,No significant differences were noted between the two groups in the levels of transcutaneous bilirubin before phototherapy ( p  > 0.05).,"[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ""Neonatal Intensive Care Unit, Hangzhou Women's Hospital (Hangzhou Maternity and Child Health Care Hospital), Hangzhou, China.""}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Neonatal Intensive Care Unit, Hangzhou Women's Hospital (Hangzhou Maternity and Child Health Care Hospital), Hangzhou, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': ""Neonatal Intensive Care Unit, Hangzhou Women's Hospital (Hangzhou Maternity and Child Health Care Hospital), Hangzhou, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Yao', 'Affiliation': ""Neonatal Intensive Care Unit, Hangzhou Women's Hospital (Hangzhou Maternity and Child Health Care Hospital), Hangzhou, China.""}, {'ForeName': 'Weinong', 'Initials': 'W', 'LastName': 'Mo', 'Affiliation': ""Neonatal Intensive Care Unit, Hangzhou Women's Hospital (Hangzhou Maternity and Child Health Care Hospital), Hangzhou, China.""}]",American journal of perinatology,['10.1055/s-0040-1717069']
252,32882355,Psychological Distress in Bereaved Caregivers of Patients With Advanced Cancer.,"CONTEXT


Individuals caring for patients with advanced cancer (caregivers) experience psychological distress during the patient's illness course. However, data on the prevalence of bereaved caregivers' psychological distress and its relationship with the quality of patient's end of life (EOL) care are limited.
OBJECTIVES


To describe rates of depression and anxiety symptoms in bereaved caregivers of patients with advanced cancer and to understand the relationship between these outcomes and patient distress at the EOL.
METHODS


We conducted a secondary analysis of 168 caregivers enrolled in a supportive care trial for patients with incurable lung and gastrointestinal cancers and their caregivers. We used the Hospital Anxiety and Depression Scale to assess caregivers' depression and anxiety symptoms at three months after the patient's death. Caregivers also rated the patient's physical and psychological distress in the last week of life on a 10-point scale three months after the patient death. We used linear regression adjusting for caregiver age, sex, randomization, and cancer type to explore the relationship between bereaved caregivers' depression and anxiety symptoms and their ratings of physical and psychological distress in patients at the EOL.
RESULTS


Of the 168 bereaved caregivers, 30.4% (n = 51) and 43.4% (n = 73) reported clinically significant depression and anxiety symptoms, respectively. Caregiver ratings of worse physical (B = 0.32; P = 0.009) and psychological (B = 0.50; P < 0.001) distress experienced by the patient at the EOL were associated with worse depression symptoms in bereaved caregivers. Only caregiver rating of worse psychological distress experienced by the patient at the EOL (B = 0.42; P < 0.001) was associated with worse bereaved caregivers' anxiety symptoms.
CONCLUSION


Many bereaved caregivers of patients with advanced cancer experience symptoms of depression and anxiety, which are associated with their perceptions of distress in their loved ones at the EOL.",2021,Caregiver ratings of worse physical (B = 0.32; P = 0.009) and psychological (B = 0.50; P < 0.001) distress experienced by the patient at the EOL were associated with worse depression symptoms in bereaved caregivers.,"['Bereaved Caregivers of Patients With Advanced Cancer', '168 caregivers enrolled in a supportive care trial for patients with incurable lung and gastrointestinal cancers and their caregivers', 'bereaved caregivers of patients with advanced cancer', ""patients with advanced cancer (caregivers) experience psychological distress during the patient's illness course"", 'patients at the EOL']",[],"['anxiety symptoms and their ratings of physical and psychological distress', 'caregiver rating of worse psychological distress', 'Psychological Distress', ""patient's physical and psychological distress"", 'Caregiver ratings of worse physical', ""Hospital Anxiety and Depression Scale to assess caregivers' depression and anxiety symptoms"", 'depression and anxiety symptoms']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",[],"[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",168.0,0.0825236,Caregiver ratings of worse physical (B = 0.32; P = 0.009) and psychological (B = 0.50; P < 0.001) distress experienced by the patient at the EOL were associated with worse depression symptoms in bereaved caregivers.,"[{'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA. Electronic address: ael-jawahri@partners.org.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Vicki A', 'Initials': 'VA', 'LastName': 'Jackson', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA; Division of Palliative Care, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Kamdar', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA; Division of Palliative Care, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Simone P', 'Initials': 'SP', 'LastName': 'Rinaldi', 'Affiliation': 'Division of Palliative Care, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Gallagher', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Annemarie D', 'Initials': 'AD', 'LastName': 'Jagielo', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Carlisle E W', 'Initials': 'CEW', 'LastName': 'Topping', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Elyze', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Bailey', 'Initials': 'B', 'LastName': 'Jones', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.08.028']
253,32985230,Caregiver Speaks Study Protocol: A Technologically-Mediated Storytelling Intervention for Hospice Family Caregivers of Persons Living With Dementia.,"OBJECTIVE


We present the protocol of a study aiming to examine the efficacy of a technologically-mediated storytelling intervention called Caregiver Speaks in reducing distress and grief intensity experienced by active and bereaved hospice family caregivers of persons living with dementia (PLWD).
DESIGN


The study is a mixed-method, 2-group, randomized controlled trial.
SETTING


This study takes place in 5 hospice agencies in the Midwest and Northeastern United States.
PARTICIPANTS


Participants include hospice family caregivers of PLWD.
INTERVENTION


Participants are randomized to usual hospice care or the intervention group. In the Caregiver Speaks intervention, caregivers engage in photo-elicitation storytelling (sharing photos that capture their thoughts, feelings, and reactions to caregiving and bereavement) via a privately facilitated Facebook group. This intervention will longitudinally follow caregivers from active caregiving into bereavement. The usual care group continues to receive hospice care but does not participate in the online group.
OUTCOMES MEASURED


We anticipate enrolling 468 participants. Our primary outcomes of interest are participant depression and anxiety, which are measured by the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder screening (GAD-7). Our secondary outcomes of interest are participants' perceived social support, measured by the Perceived Social Support for Caregiving (PSSC) scale, and grief intensity, which is measured by the Texas Revised Inventory of Grief Present Subscale (TRIG-Present).",2021,"OBJECTIVE


We present the protocol of a study aiming to examine the efficacy of a technologically-mediated storytelling intervention called Caregiver Speaks in reducing distress and grief intensity experienced by active and bereaved hospice family caregivers of persons living with dementia (PLWD).
","['persons living with dementia (PLWD', 'enrolling 468 participants', 'Participants include hospice family caregivers of PLWD', '5 hospice agencies in the Midwest and Northeastern United States', 'Hospice Family Caregivers of Persons Living With Dementia']","['Technologically-Mediated Storytelling Intervention', 'technologically-mediated storytelling intervention called Caregiver Speaks']","['participant depression and anxiety, which are measured by the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder screening (GAD-7', 'social support, measured by the Perceived Social Support for Caregiving (PSSC) scale, and grief intensity, which is measured by the Texas Revised Inventory of Grief Present Subscale (TRIG-Present']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}]",468.0,0.0535154,"OBJECTIVE


We present the protocol of a study aiming to examine the efficacy of a technologically-mediated storytelling intervention called Caregiver Speaks in reducing distress and grief intensity experienced by active and bereaved hospice family caregivers of persons living with dementia (PLWD).
","[{'ForeName': 'Abigail J', 'Initials': 'AJ', 'LastName': 'Rolbiecki', 'Affiliation': '14716University of Missouri, Department of Family and Community Medicine, Columbia, MO, USA.'}, {'ForeName': 'Debra Parker', 'Initials': 'DP', 'LastName': 'Oliver', 'Affiliation': '14716University of Missouri, Department of Family and Community Medicine, Columbia, MO, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Teti', 'Affiliation': '14716University of Missouri, Department of Public Health, Columbia, MO, USA.'}, {'ForeName': 'Karla T', 'Initials': 'KT', 'LastName': 'Washington', 'Affiliation': '14716University of Missouri, Department of Family and Community Medicine, Columbia, MO, USA.'}, {'ForeName': 'Jacquelyn J', 'Initials': 'JJ', 'LastName': 'Benson', 'Affiliation': '14716University of Missouri, Department of Human Development and Family Science, Columbia, MO, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Kruse', 'Affiliation': '14716University of Missouri, Department of Family and Community Medicine, Columbia, MO, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': '14716University of Missouri, Department of Family and Community Medicine, Columbia, MO, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Demiris', 'Affiliation': '6572University of Pennsylvania, School of Nursing, Philadelphia, PA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ersek', 'Affiliation': '6572University of Pennsylvania, School of Nursing, Philadelphia, PA, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Mehr', 'Affiliation': '14716University of Missouri, Department of Family and Community Medicine, Columbia, MO, USA.'}]",The American journal of hospice & palliative care,['10.1177/1049909120960449']
254,33021143,Objective analysis of language use in cognitive-behavioral therapy: associations with symptom change in adults with co-occurring substance use disorders and posttraumatic stress.,"Substance use disorders (SUD) commonly co-occur with posttraumatic stress disorder (PTSD) symptoms, and the comorbidity is prevalent and difficult-to-treat. Few studies have objectively analyzed language use in psychotherapy as a predictor of treatment outcomes. We conducted a secondary analysis of patient language use during cognitive-behavioral therapy (CBT) in a randomized clinical trial, comparing a novel, integrated CBT for PTSD/SUD with standard CBT for SUD. Participants included 37 treatment-seeking, predominantly African-American adults with SUD and at least four symptoms of PTSD. We analyzed transcripts of a single, matched session across both treatment conditions, using the Linguistic Inquiry and Word Count (LIWC) program. The program measures language use across multiple categories. Compared to standard CBT for SUD, patients in the novel, integrated CBT for PTSD/SUD used more negative emotion words, partially consistent with our hypothesis, but less positive emotion words. Further, exploratory analyses indicated an association between usage of cognitive processing words and clinician-observed reduction in PTSD symptoms, regardless of treatment condition. Our results suggest that language use during therapy may provide a window into mechanisms active in therapy.",2021,"Compared to standard CBT for SUD, patients in the novel, integrated CBT for PTSD/SUD used more negative emotion words, partially consistent with our hypothesis, but less positive emotion words.","['Participants included 37 treatment-seeking, predominantly African-American adults with SUD and at least four symptoms of PTSD', 'adults with co-occurring substance use disorders and posttraumatic stress']","['language use in cognitive-behavioral therapy', 'patient language use during cognitive-behavioral therapy (CBT']",['positive emotion words'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]",37.0,0.0173698,"Compared to standard CBT for SUD, patients in the novel, integrated CBT for PTSD/SUD used more negative emotion words, partially consistent with our hypothesis, but less positive emotion words.","[{'ForeName': 'Anthony N', 'Initials': 'AN', 'LastName': 'Jennings', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center , Houston, TX, USA.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Soder', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center , Houston, TX, USA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Wardle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center , Houston, TX, USA.'}, {'ForeName': 'Joy M', 'Initials': 'JM', 'LastName': 'Schmitz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center , Houston, TX, USA.'}, {'ForeName': 'Anka A', 'Initials': 'AA', 'LastName': 'Vujanovic', 'Affiliation': 'Department of Psychology, University of Houston , Houston, TX, USA.'}]",Cognitive behaviour therapy,['10.1080/16506073.2020.1819865']
255,32980245,The Impact of a Family-Based Economic Intervention on the Mental Health of HIV-Infected Adolescents in Uganda: Results From Suubi + Adherence.,"PURPOSE


This study examines the extent to which three mental health measures (hopelessness, depression, and poor self-concept) are improved through a family-based economic intervention implemented among adolescents living with HIV in Uganda.
METHODS


We used repeated measures from Suubi + Adherence, a large-scale 6-year (2012-2018) longitudinal randomized controlled trial. Bivariate analyses were conducted to test for observable group differences between the intervention and control conditions. Multilevel piecewise repeated measure mixed models were then conducted to assess hypothesized time × intervention interaction in changes in hopelessness, depression, and self-concept using participant-specific follow-up intervals.
RESULTS


At 24-month postintervention initiation, adolescents in the intervention condition reported a statistically significant lower hopelessness score than adolescents in the control condition (4.79 vs. 5.56; p = .018; N = 358). At 36-month follow-up, the intervention condition reported a statistically significant lower score on depression in the depression subgroup (N = 344) than the control condition (4.94 vs. 5.81; p = .029).
CONCLUSIONS


The results indicate that family-based economic interventions such as Suubi + Adherence can effectively improve the mental health of adolescents living with HIV who evidenced mental health challenges at baseline. Given the promising positive effects of these interventions, at least in the short term, future studies should investigate strategies to promote the sustainability of these mental health benefits.",2021,"At 36-month follow-up, the intervention condition reported a statistically significant lower score on depression in the depression subgroup (N = 344) than the control condition (4.94 vs. 5.81; p = .029).
","['Mental Health of HIV-Infected Adolescents in Uganda', 'adolescents living with HIV in Uganda']",['Family-Based Economic Intervention'],"['hopelessness, depression, and self-concept', 'hopelessness score', 'depression', 'mental health']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0398527,"At 36-month follow-up, the intervention condition reported a statistically significant lower score on depression in the depression subgroup (N = 344) than the control condition (4.94 vs. 5.81; p = .029).
","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Cavazos-Rehg', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri. Electronic address: pcavazos@wustl.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri; Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Borodovsky', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Kasson', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Nnenna', 'Initials': 'N', 'LastName': 'Anako', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri; Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Mellins', 'Affiliation': 'Departments of Psychiatry and Sociomedical Sciences, Columbia University, New York, New York.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'International Center for Child Health and Development, Masaka Field Office, Masaka, Uganda.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Neilands', 'Affiliation': 'Center for AIDS Prevention Studies, University of California, San Francisco, School of Medicine, San Francisco, California.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, Missouri.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.07.022']
256,31408030,Social harms in female-initiated HIV prevention method research: state of the evidence.,"OBJECTIVES


Assessment of safety is an integral part of real-time monitoring in clinical trials. In HIV prevention research, safety of investigational products and trial participation has been expanded to include monitoring for 'social harms', generally defined as negative consequences of trial participation that may manifest in social, psychological, or physical ways. Further research on social harms within HIV prevention research is needed to understand the potential safety risks for women and advance the implementation of prevention methods in real-world contexts.
METHODS


Secondary analysis of quantitative data from three randomized, double-blind, placebo-controlled trials of microbicide candidates in sub-Saharan Africa was conducted. Additionally, we assessed data from two prospective cohort studies that included participants who became HIV-positive or pregnant during parent trials.
RESULTS


Social harms reporting was low across the largest and most recent microbicide studies. Social harm incidence per 100 person-years ranged from 1.10 (95% CI 0.78-1.52) to 3.25 (95% CI 2.83-3.74) in the phased trials. Reporting differed by dosing mechanism (e.g. vaginal gel, oral tablet, ring) and study, most likely as a function of measurement differences. Social harms were most frequently associated with male partners, rather than, for example, experiences of stigma in the community.
CONCLUSION


Measurement and screening for social harms is an important component of conducting ethical research of novel HIV prevention methods. To date, social harm incidence reported in microbicide trials has been relatively low (<4% per 100 person-years), and the majority have been partner-related events. However, any incidence of social harm within the context of HIV prevention is important to capture and understand for the safety of individuals, and for the successful impact of prevention methods in a real-world context.",2019,"Social harms were most frequently associated with male partners, rather than, for example, experiences of stigma in the community.
",['participants who became HIV-positive or pregnant during parent trials'],['placebo'],[],"[{'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.29149,"Social harms were most frequently associated with male partners, rather than, for example, experiences of stigma in the community.
","[{'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Montgomery', 'Affiliation': ""aWomen's Global Health Imperative, RTI International, San Francisco, California, USA bInternational Partnership for Microbicides (IPM), Paarl, South Africa cFHI 360, Durham, North Carolina, USA dUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA eUniversity of Washington, Seattle, Washington, USA fUniversity of Alabama, Birmingham, Alabama, USA gUniversity of Zimbabwe, Harare, Zimbabwe hMakerere University, Kampala, Uganda iSouth African Medical Research Council HIV Prevention Research Unit, Durban, South Africa jWits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa kCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.""}, {'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Roberts', 'Affiliation': ''}, {'ForeName': 'Annalene', 'Initials': 'A', 'LastName': 'Nel', 'Affiliation': ''}, {'ForeName': 'Mariette', 'Initials': 'M', 'LastName': 'Malherbe', 'Affiliation': ''}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Torjesen', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Bunge', 'Affiliation': ''}, {'ForeName': 'Devika', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': ''}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Marrazzo', 'Affiliation': ''}, {'ForeName': 'Z Mike', 'Initials': 'ZM', 'LastName': 'Chirenje', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Kabwigu', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beigi', 'Affiliation': ''}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Riddler', 'Affiliation': ''}, {'ForeName': 'Zakir', 'Initials': 'Z', 'LastName': 'Gaffour', 'Affiliation': ''}, {'ForeName': 'Krishnaveni', 'Initials': 'K', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Leila E', 'Initials': 'LE', 'LastName': 'Mansoor', 'Affiliation': ''}, {'ForeName': 'Gonasagrie', 'Initials': 'G', 'LastName': 'Nair', 'Affiliation': ''}, {'ForeName': 'Kusbashni', 'Initials': 'K', 'LastName': 'Woeber', 'Affiliation': ''}, {'ForeName': 'Jayajothi', 'Initials': 'J', 'LastName': 'Moodley', 'Affiliation': ''}, {'ForeName': 'Nitesha', 'Initials': 'N', 'LastName': 'Jeenarain', 'Affiliation': ''}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Siva', 'Affiliation': ''}, {'ForeName': 'Logashvari', 'Initials': 'L', 'LastName': 'Naidoo', 'Affiliation': ''}, {'ForeName': 'Vaneshree', 'Initials': 'V', 'LastName': 'Govender', 'Affiliation': ''}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002346']
257,33261915,Support for a nicotine reduction policy among participants enrolled in a 20-week trial of very low nicotine content cigarettes.,"INTRODUCTION


The Food and Drug Administration is considering a policy to drastically reduce the allowable nicotine content of cigarettes. The current study examined whether the policy implementation approach, i.e., either immediately reducing nicotine content to very low levels or gradually reducing nicotine content over an extended period, influences policy support among people who smoke cigarettes.
METHODS


Adults who smoked daily were randomly assigned (double-blind) to an immediate nicotine reduction condition (0.4 mg/g nicotine cigarettes), a gradual nicotine reduction condition (15.5 to 0.4 mg/g), or a control condition (15.5 mg/g) for 20 weeks. Participants were asked if they would ""support or oppose a law that reduced the amount of nicotine in cigarettes, to make cigarettes less addictive."" Logistic regression analyses assessed if policy support was affected by treatment condition, demographic covariates, interest in quitting, and subjective cigarette effects.
RESULTS


At Week 20 (N = 957 completers), 60.4% of participants supported the policy, 17.4% opposed, and 22.2% responded ""Don't know."" Policy support did not differ by treatment condition. Support was greater among those interested in quitting (OR = 3.37, 95% CI = 2.49, 4.55). Support was lower among males (OR = 0.49, 95% CI = 0.37, 0.67), those with greater dependence scores (OR = 0.92, 95% CI = 0.86, 0.99) and participants aged 18-24 (OR = 0.53, 95% CI = 0.28, 0.99). No other covariates were associated with policy support.
CONCLUSIONS


The majority of participants supported a nicotine reduction policy. The implementation approach, immediate or gradual reduction, did not affect policy support. Participants interested in quitting smoking were more likely to support a nicotine reduction policy.",2021,"Support was lower among males (OR = 0.49, 95% CI = 0.37, 0.67), those with greater dependence scores (OR = 0.92, 95% CI = 0.86, 0.99) and participants aged 18-24 (OR = 0.53, 95% CI = 0.28, 0.99).","['participants enrolled in a 20-week trial of very low nicotine content cigarettes', 'people who smoke cigarettes', 'Adults who smoked daily']","['gradual nicotine reduction condition', 'immediate nicotine reduction condition (0.4\xa0mg/g nicotine cigarettes']","['demographic covariates, interest in quitting, and subjective cigarette effects', 'quitting smoking']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.0512707,"Support was lower among males (OR = 0.49, 95% CI = 0.37, 0.67), those with greater dependence scores (OR = 0.92, 95% CI = 0.86, 0.99) and participants aged 18-24 (OR = 0.53, 95% CI = 0.28, 0.99).","[{'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA. Electronic address: rdenling@wakehealth.edu.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Koopmeiners', 'Affiliation': 'Division of Biostatistics, School of Public Health and Masonic Cancer Center, University of Minnesota, Minneapolis, MN 55455, USA. Electronic address: koopm007@umn.edu.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI 02912, USA. Electronic address: jennifer_tidey@brown.edu.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Division of Biostatistics, School of Public Health and Masonic Cancer Center, University of Minnesota, Minneapolis, MN 55455, USA. Electronic address: luox0054@umn.edu.'}, {'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Hollings Cancer Center and Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC 29425, USA. Electronic address: smithtra@musc.edu.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Pacek', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC 27705, USA. Electronic address: lauren.pacek@duke.edu.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Joseph McClernon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC 27705, USA.'}, {'ForeName': 'Joni A', 'Initials': 'JA', 'LastName': 'Jensen', 'Affiliation': 'Masonic Cancer Center and Department of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, MN 55455, USA. Electronic address: jense010@umn.edu.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Department Psychiatry and Human Behavior, Brown University, Providence, RI 02912, USA. Electronic address: suzanne_colby@brown.edu.'}, {'ForeName': 'Herbert H', 'Initials': 'HH', 'LastName': 'Severson', 'Affiliation': 'Oregon Research Institute, Eugene, OR 97403, USA. Electronic address: herb@ori.org.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA. Electronic address: edonny@wakehealth.edu.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center and Department of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, MN 55455, USA. Electronic address: hatsu001@umn.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106727']
258,32960272,CYP2B6 Genotype and Weight Gain Differences Between Dolutegravir and Efavirenz.,"BACKGROUND


Dolutegravir is associated with more weight gain than efavirenz. Loss-of-function polymorphisms in CYP2B6 result in higher efavirenz concentrations, which we hypothesized would impair weight gain among people living with human immunodeficiency virus (HIV; PLWH) starting efavirenz-based antiretroviral therapy (ART).
METHODS


We studied ART-naive participants from the ADVANCE study randomized to the efavirenz /emtricitabine/tenofovir disoproxil fumarate (TDF) and dolutegravir/emtricitabine/TDF arms. We compared changes in weight and regional fat on DXA from baseline to week 48 between CYP2B6 metabolizer genotypes in the efavirenz arm, and with the dolutegravir arm.
RESULTS


There were 342 participants in the dolutegravir arm and 168 in the efavirenz arm who consented to genotyping. Baseline characteristics were similar. Weight gain was greater in women than men. In the efavirenz arm CYP2B6 metaboliser genotype was associated with weight gain (P = .009), with extensive metabolizers gaining the most weight, and with changes in regional fat in women, but not in men. Weight gain was similar in CYP2B6 extensive metabolizers in the efavirenz arm and in the dolutegravir arm (P = .836). The following variables were independently associated with weight gain in all participants: baseline CD4 count, baseline human immunodeficiency virus type 1 (HIV-1) RNA, and CYP2B6 metaboliser genotype.
CONCLUSIONS


CYP2B6 metaboliser genotype was associated with weight gain in PLWH starting efavirenz-based ART. Weight gain was similar between CYP2B6 extensive metabolizers in the efavirenz arm and in the dolutegravir arm, suggesting that impaired weight gain among CYP2B6 slow or intermediate metabolizers could explain the increased weight gain on dolutegravir compared with efavirenz observed in ADVANCE and other studies.",2021,"In the efavirenz arm CYP2B6 metaboliser genotype was associated with weight gain (P = .009), with extensive metabolizers gaining the most weight, and with changes in regional fat in women, but not in men.","['342 participants in the dolutegravir arm and 168 in the efavirenz arm who consented to genotyping', 'people living with human immunodeficiency virus (HIV; PLWH) starting efavirenz-based antiretroviral therapy (ART']","['efavirenz /emtricitabine/tenofovir disoproxil fumarate (TDF) and dolutegravir/emtricitabine/TDF arms', 'efavirenz', 'Efavirenz']","['weight gain', 'Weight gain', 'weight and regional fat on DXA', 'CYP2B6 Genotype and Weight Gain Differences', 'baseline CD4 count, baseline human immunodeficiency virus type 1 (HIV-1) RNA, and CYP2B6 metaboliser genotype']","[{'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C2929052', 'cui_str': 'tenofovir disoproxil and emtricitabine'}, {'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0534137', 'cui_str': 'CYP2B6 protein, human'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",342.0,0.122371,"In the efavirenz arm CYP2B6 metaboliser genotype was associated with weight gain (P = .009), with extensive metabolizers gaining the most weight, and with changes in regional fat in women, but not in men.","[{'ForeName': 'Rulan', 'Initials': 'R', 'LastName': 'Griesel', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Maartens', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Chirehwa', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Simiso', 'Initials': 'S', 'LastName': 'Sokhela', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Godspower', 'Initials': 'G', 'LastName': 'Akpomiemie', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Moorhouse', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Venter', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Phumla', 'Initials': 'P', 'LastName': 'Sinxadi', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1073']
259,32975020,Does a physical therapist-administered physical activity intervention reduce sedentary time after total knee replacement: An exploratory study?,,2021,,['total knee replacement'],['physical therapist-administered physical activity intervention'],[],"[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0172209,,"[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Coleman', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'White', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Thoma', 'Affiliation': 'Division of Physical Therapy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Mathews', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Meredith B', 'Initials': 'MB', 'LastName': 'Christiansen', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Schmitt', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Jakiela', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Hiral', 'Initials': 'H', 'LastName': 'Master', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware, Newark, Delaware, USA.'}]",Musculoskeletal care,['10.1002/msc.1517']
260,33001556,Association of a glucagon-like peptide-1 receptor gene variant with glucose response to a mixed meal.,"Dipeptidyl peptidase-4 (DPP-4) inhibitors increase endogenous glucagon-like peptide-1 (GLP-1). We hypothesized that genetic variation in the gene encoding the GLP-1 receptor (GLP1R) could affect the metabolic response to DPP-4 inhibition. To evaluate the relationship between the GLP1R rs6923761 variant (G-to-A nucleic acid substitution) and metabolic responses, we performed mixed meal studies in individuals with type 2 diabetes mellitus and hypertension after 7-day treatment with placebo and the DPP-4 inhibitor sitagliptin. This analysis is a substudy of NCT02130687. The genotype frequency was 13:12:7 GG:GA:AA among individuals of European ancestry. Postprandial glucose excursion was significantly decreased in individuals carrying the rs6923761 variant (GA or AA) as compared with GG individuals during both placebo (P = 0.001) and sitagliptin treatment (P = 0.045), while intact GLP-1 levels were similar among the genotype groups. In contrast, sitagliptin lowered postprandial glucose to a greater degree in GG as compared with GA/AA individuals (P = 0.035). The relationship between GLP1R rs6923761 genotype and therapies that modulate GLP-1 signalling merits study in large populations.",2021,"Post-prandial glucose excursion was significantly decreased in individuals carrying the rs6923761 variant (GA or AA) as compared with GG individuals during both placebo (P=0.001) and sitagliptin treatment (P=0.045), while intact GLP-1 levels were similar among the genotype groups.","['individuals of European ancestry', 'individuals with type 2 diabetes mellitus and hypertension after seven-day treatment with placebo and the DPP4 inhibitor sitagliptin']","['placebo', 'Dipeptidyl peptidase-4 (DPP4) inhibitors']","['intact GLP-1 levels', 'Post-prandial glucose excursion']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.0555337,"Post-prandial glucose excursion was significantly decreased in individuals carrying the rs6923761 variant (GA or AA) as compared with GG individuals during both placebo (P=0.001) and sitagliptin treatment (P=0.045), while intact GLP-1 levels were similar among the genotype groups.","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Mashayekhi', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Wilson', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of Pennsylvania Department of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Jafarian-Kerman', 'Affiliation': 'Division of Applied Regulatory Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Nian', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Shuey', 'Affiliation': 'Division of Genetic Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Luther', 'Affiliation': 'Division of Clinical Pharmacology, Vanderbilt Department of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Brown', 'Affiliation': 'Division of Clinical Pharmacology, Vanderbilt Department of Medicine, Nashville, Tennessee, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14216']
261,33003548,The Effects of a 12-Month Weight Loss Intervention on Cognitive Outcomes in Adults with Overweight and Obesity.,"Obesity is associated with poorer executive functioning and reward sensitivity. Yet, we know very little about whether weight loss through diet and/or increased exercise engagement improves cognitive function. This study evaluated whether weight loss following a dietary and exercise intervention was associated with improved cognitive performance. We enrolled 125 middle-aged adults with overweight and obesity (98 female) into a 12-month behavioral weight loss intervention. Participants were assigned to one of three groups: energy-restricted diet alone, an energy-restricted diet plus 150 min of moderate intensity exercise per week or an energy restricted diet plus 250 min of exercise per week. All participants completed tests measuring executive functioning and/or reward sensitivity, including the Iowa Gambling Task (IGT). Following the intervention, weight significantly decreased in all groups. A MANCOVA controlling for age, sex and race revealed a significant multivariate effect of group on cognitive changes. Post-hoc ANCOVAs revealed a Group x Time interaction only on IGT reward sensitivity, such that the high exercise group improved their performance relative to the other two intervention groups. Post-hoc ANCOVAs also revealed a main effect of Time, independent of intervention group, on IGT net payoff score. Changes in weight were not associated with other changes in cognitive performance. Engaging in a high amount of exercise improved reward sensitivity above and beyond weight loss alone. This suggests that there is additional benefit to adding exercise into behavioral weight loss regimens on executive functioning, even without additional benefit to weight loss.",2020,"Post-hoc ANCOVAs also revealed a main effect of Time, independent of intervention group, on IGT net payoff score.","['125 middle-aged adults with overweight and obesity (98 female) into a 12-month behavioral weight loss intervention', 'Adults with Overweight and Obesity']","['energy-restricted diet alone, an energy-restricted diet plus 150 min of moderate intensity exercise per week or an energy restricted diet plus 250 min of exercise per week', 'dietary and exercise intervention', 'Weight Loss Intervention']","['cognitive performance', 'weight loss', 'weight', 'executive functioning and/or reward sensitivity, including the Iowa Gambling Task (IGT', 'IGT net payoff score', 'Cognitive Outcomes', 'reward sensitivity above and beyond weight loss alone']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",125.0,0.0173392,"Post-hoc ANCOVAs also revealed a main effect of Time, independent of intervention group, on IGT net payoff score.","[{'ForeName': 'Jamie C', 'Initials': 'JC', 'LastName': 'Peven', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Healthy Lifestyle Institute, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Renee J', 'Initials': 'RJ', 'LastName': 'Rogers', 'Affiliation': 'Healthy Lifestyle Institute, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Lesnovskaya', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Kirk I', 'Initials': 'KI', 'LastName': 'Erickson', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Chaeryon', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Xueping', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Porter', 'Affiliation': 'Department of Psychology, Carnegie Mellon University, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Shannon D', 'Initials': 'SD', 'LastName': 'Donofry', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Watt', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}, {'ForeName': 'Chelsea M', 'Initials': 'CM', 'LastName': 'Stillman', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260, USA.'}]",Nutrients,['10.3390/nu12102988']
262,33021670,Increasing Life-Space Mobility in Community-Dwelling Older Persons With Cognitive Impairment Following Rehabilitation: A Randomized Controlled Trial.,"BACKGROUND


Community-dwelling older persons with cognitive impairment (CI) following discharge from geriatric rehabilitation are at high risk of losing life-space mobility (LSM). Interventions to improve their LSM are, however, still lacking. The aim of this study was to evaluate the effects of a CI-specific, home-based physical training and activity promotion program on LSM.
METHODS


Older persons with mild-to-moderate CI (Mini-Mental State Examination: 17-26 points) discharged home from rehabilitation were included in this double-blinded, randomized, placebo-controlled trial with a 12-week intervention period and 12-week follow-up period. The intervention group received a CI-specific, home-based strength, balance, and walking training supported by tailored motivational strategies. The control group received a placebo activity. LSM was evaluated by the Life-Space Assessment in Persons with Cognitive Impairment, including a composite score for LSM and 3 subscores for maximal, equipment-assisted, and independent life space. Mixed-model repeated-measures analyses were used.
RESULTS


One hundred eighteen participants (82.3 ± 6.0 years) with CI (Mini-Mental State Examination: 23.3 ± 2.4) were randomized. After the intervention, the home-based training program resulted in a significant benefit in the Life-Space Assessment in Persons with Cognitive Impairment composite scores (b = 8.15; 95% confidence interval: 2.89-13.41; p = .003) and independent life-space subscores (b = 0.39; 95% confidence interval: 0.00-0.78; p = .048) in the intervention group (n = 63) compared to control group (n = 55). Other subscores and follow-up results were not significantly different.
CONCLUSIONS


The home-based training program improved LSM and independent life space significantly in this vulnerable population. Effects were not sustained over the follow-up. The program may represent a model for improved transition from rehabilitation to the community to prevent high risk of LSM restriction.",2021,"After the intervention, the home-based training program resulted in a significant benefit in the LSA-CI composite scores (b=8.15; 95% confidence interval: 2.89-13.41; p=.003) and independent life-space sub-scores (b= 0.39;","['community-dwelling older persons with cognitive impairment following rehabilitation', 'One hundred eighteen participants (82.3±6.0 years) with CI (MMSE: 23.3±2.4) were randomized', 'Community-dwelling older persons with cognitive impairment (CI', 'Older persons with mild-to-moderate CI (Mini-Mental State Examination [MMSE]: 17-26 points) discharged home from rehabilitation', 'Persons with Cognitive Impairment (LSA-CI']","['CI-specific, home-based strength, balance and walking training supported by tailored motivational strategies', 'CI-specific, home-based physical training and activity promotion program', 'placebo activity', 'placebo', 'LSM']","['life-space sub-scores', 'LSA-CI composite scores']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0023652', 'cui_str': 'Lichen sclerosus et atrophicus'}]","[{'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023652', 'cui_str': 'Lichen sclerosus et atrophicus'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",118.0,0.12261,"After the intervention, the home-based training program resulted in a significant benefit in the LSA-CI composite scores (b=8.15; 95% confidence interval: 2.89-13.41; p=.003) and independent life-space sub-scores (b= 0.39;","[{'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Ullrich', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg, Geriatric Center at the Heidelberg University, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Werner', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg, Geriatric Center at the Heidelberg University, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bongartz', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg, Geriatric Center at the Heidelberg University, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Eckert', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg, Geriatric Center at the Heidelberg University, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Abel', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg, Geriatric Center at the Heidelberg University, Germany.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Schönstein', 'Affiliation': 'Network Aging Research, Heidelberg University, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Kiss', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg, Geriatric Center at the Heidelberg University, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hauer', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg, Geriatric Center at the Heidelberg University, Germany.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa254']
263,33277203,The effect of music and skin contact with the newborn on pain and anxiety during episiotomy repair in primiparous women: A double-blind randomized controlled study.,"OBJECTIVE


To show that music medicine and skin contact with the newborns can reduce pain and anxiety during episiotomy repair.
DESIGN


Double-blind randomized controlled trial SETTING: The study was conducted between April and July 2020 at the private Medipol Nisa Hospital.
PARTICIPANTS


A total of 150 primiparous pregnant women over 20 years of age who underwent vaginal delivery with episiotomy INTERVENTIONS: Participants were randomized into the music medicine, skin contact with the newborn, and control groups (with no treatment). After episiotomy repair (with the designated treatment or no treatment), the State Trait Anxiety Inventory and Visual Analog Scale were used to assess anxiety and pain, respectively.
MAIN OUTCOME MEASURES


Pain and anxiety experienced after episiotomy repair in the treatment and control groups.
RESULTS


Women in both treatment groups (music medicine and skin-to-skin contact) had significantly lower anxiety and pain levels than those in the control group. In particular, music medicine significantly reduced pain in comparison to skin contact with the newborn (VAS 2 3.92 ± 1.46 vs. 5.42 ± 1.73, respectively, VAS 3 2.64 ± 1.63 vs. 5.14 ± 1.77, respectively, VAS 4 1.38 ± 1.46 vs. 4.14 ± 2.04, respectively, p < 0.05). Thus, music medicine is more effective than skin-to-skin contact in reducing the pain experienced during episiotomy repair, but both treatments were equally effective in reducing anxiety (35.30 ± 6.47 vs. 36.82 ± 9.71 vs. 49.22 ± 16.95, respectively, p < 0.05).
CONCLUSION


Both of these nonpharmacological treatments can be used along with analgesics and anxiolytics for the treatment of pain and anxiety during episiotomy repair.",2022,"RESULTS


Women in both treatment groups (music medicine and skin-to-skin contact) had significantly lower anxiety and pain levels than those in the control group.","['primiparous women', '150 primiparous pregnant women over 20 years of age who underwent vaginal delivery with episiotomy', 'April and July 2020 at the private Medipol Nisa Hospital']","['music medicine, skin contact with the newborn, and control groups (with no treatment', 'music and skin contact with the newborn']","['anxiety and pain levels', 'Pain and anxiety experienced after episiotomy repair', 'State Trait Anxiety Inventory and Visual Analog Scale', 'pain', 'pain and anxiety']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0014585', 'cui_str': 'Repair of episiotomy'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",150.0,0.0826557,"RESULTS


Women in both treatment groups (music medicine and skin-to-skin contact) had significantly lower anxiety and pain levels than those in the control group.","[{'ForeName': 'Ayça', 'Initials': 'A', 'LastName': 'Şolt Kırca', 'Affiliation': 'Kirklareli University School of Health, Midwifery Depertmant Kirklareli, Turkey. Electronic address: aycasolt@hotmail.com.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Kanza Gül', 'Affiliation': 'Medipol University School of Medicine Health, Istanbul, Turkey.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.11.007']
264,33278717,Implementation of a cluster randomized controlled trial: Identifying student peer leaders to lead E-cigarette interventions.,"E-cigarette use has been increasing among middle school students. Intervention programs to prevent e-cigarette initiation administered by authority figures are met with more resistance from youth compared to peer-led programs. Therefore, this study aimed to assess the feasibility, acceptability, and implementation process of using social network analysis (SNA) to identify student peer leaders in schools and train them to deliver e-cigarette prevention programming to their peers. Nine schools were recruited to participate in the study during the 2019-2020 school year. Schools were assigned to one of three conditions: (1) expert; (2) peer-random (selected peer-leaders would teach to random students); and (3) peer-fixed (selected peer-leaders would teach to assigned students based on nominations). Study participation varied by day due to school attendance, with 686 participants at baseline and 608 at posttest. Almost all students who did not complete the study resulted from the interruption of schools being closed due to COVID-19. Implementation issues fell into three categories: (1) scheduling, (2) day-of logistics, and (3) student group dynamics. Overall, the results showed positive satisfaction among teachers, who unanimously found the program appropriate for the grade-level and that peer-leaders worked well within their groups. Peer-led students-both random and assigned-reported having more fun and willing to tell friends to try the program compared to expert-led students. This study demonstrated the feasibility of implementing a peer-led e-cigarette prevention program for 6th grade students, using SNA to provide intervention rigidity and validity.",2021,Peer-led students-both random and assigned-reported having more fun and willing to tell friends to try the program compared to expert-led students.,"['middle school students', 'student peer leaders in schools and train them to deliver e-cigarette prevention programming to their peers', 'Nine schools were recruited to participate in the study during the 2019-2020 school year', '686 participants at baseline and 608 at posttest']","['peer-random (selected peer-leaders would teach to random students); and (3) peer-fixed (selected peer-leaders would teach to assigned students based on nominations', 'student peer leaders to lead E-cigarette interventions', 'social network analysis (SNA', 'implementing a peer-led e-cigarette prevention program']",[],"[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1171218', 'cui_str': 'Social network analysis'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],9.0,0.0172633,Peer-led students-both random and assigned-reported having more fun and willing to tell friends to try the program compared to expert-led students.,"[{'ForeName': 'Kar-Hai', 'Initials': 'KH', 'LastName': 'Chu', 'Affiliation': 'University of Pittsburgh, United States. Electronic address: chuk@pitt.edu.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Sidani', 'Affiliation': 'University of Pittsburgh, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Matheny', 'Affiliation': 'University of Pittsburgh, United States.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Rothenberger', 'Affiliation': 'University of Pittsburgh, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""UPMC Children's Hospital, United States.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Valente', 'Affiliation': 'University of Southern California, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Robertson', 'Affiliation': 'UPMC Hillman Cancer Center, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106726']
265,33291058,Predictors of substance use in a clinical sample of youth seeking treatment for Trauma-related mental health problems.,"Child maltreatment and traumatic events are well established risk factors for adolescent substance use problems, but little is known about the unique contributions of etiological factors on trauma-exposed youths' pre-treatment substance use in clinical settings. This study examined associations between substance use and risk and protective factors measured across multiple ecological levels among a unique sample of youth seeking treatment for trauma-related mental health problems in child advocacy centers. Participants were adolescents (N = 135; 85% female; 60% white, 31% black) aged 13-17 years (M = 15.4) with ≥ 1 experience of child maltreatment or other interpersonal violence, current substance use, and ≥5 PTSD symptoms. Youth and caregivers completed validated questionnaires and clinical interviews at a pre-treatment assessment in a randomized controlled trial of a treatment for co-occurring traumatic stress and substance use. Negative binomial regression models identified different patterns of risk and protective factors for alcohol and cannabis. Clinical implications of these results are discussed, including the potential targets for integrated psychotherapies that address co-occurring substance use and traumatic stress in youth.",2021,Youth and caregivers completed validated questionnaires and clinical interviews at a pre-treatment assessment in a randomized controlled trial of a treatment for co-occurring traumatic stress and substance use.,"['youth seeking treatment for Trauma-related mental health problems', 'Participants were adolescents (N\xa0=\xa0135; 85% female; 60% white, 31% black) aged 13-17\xa0years (M\xa0=\xa015.4) with\xa0≥\xa01 experience of child maltreatment or other interpersonal violence, current substance use, and ≥5 PTSD symptoms', 'unique sample of youth seeking treatment for trauma-related mental health problems in child advocacy centers']",[],[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517579', 'cui_str': '15.4'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008063', 'cui_str': 'Child Advocacy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],[],,0.0264869,Youth and caregivers completed validated questionnaires and clinical interviews at a pre-treatment assessment in a randomized controlled trial of a treatment for co-occurring traumatic stress and substance use.,"[{'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Adams', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA. Electronic address: zwadams@iu.edu.'}, {'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McCart', 'Affiliation': 'Oregon Social Learning Center, Eugene, OR, USA.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Chapman', 'Affiliation': 'Oregon Social Learning Center, Eugene, OR, USA.'}, {'ForeName': 'Ashli J', 'Initials': 'AJ', 'LastName': 'Sheidow', 'Affiliation': 'Oregon Social Learning Center, Eugene, OR, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Department of Psychology, Sam Houston State University, Huntsville, TX, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'de Arellano', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Carla Kmett', 'Initials': 'CK', 'LastName': 'Danielson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106742']
266,33288468,Forced-choice experiment on Anomalous Information Reception and correlations with states of consciousness using the Multivariable Multiaxial Suggestibility Inventory-2 (MMSI-2).,"CONTEXT


An Anomalous Information Reception (AIR) experiment was developed.
OBJECTIVE


To statistically examine the occurrence of AIR in multiple experimental tests and explore their predictive psychological mechanisms.
DESIGN


First, we investigated whether human beings could guess the positive or negative content from 30 randomly selected images that would be presented on a computer screen, one at a time. Ninety participants reported being mediums and another 90 claimed to be nonbelievers in the paranormal. The participants were randomly assigned to three experimental conditions: (1) positive-relaxing environments, (2) neutral environments, and (3) negative-stimulating environments. Second, the prediction of successes recorded in the AIR experiment was tested using five Multivariable Multiaxial Suggestibility Inventory-2 (MMSI-2) scales that measured the altered state of consciousness (ASC) and suggestibility.
RESULTS


The successes did not exceed the estimated chance. The only significant results revealed that mediums obtained a greater number of correct answers than the non-believing participants. Bayesian estimation also confirmed these results. In the same way, the altered states of consciousness and suggestibility negatively predicted 25.8% of successes in the AIR experiment.
CONCLUSIONS


Insufficient statistical evidence was obtained for AIR. The results raise doubts about previous theories on AIR. Further research is required. Nevertheless, mediums obtained more success answers than nonbelievers did. This means that the anomalous sheep-goat effect is also present in mediums and supports results obtained in previous studies.",2022,The only significant results revealed that mediums obtained a greater number of correct answers than the non-believing participants.,['Ninety participants reported being mediums and another 90 claimed to be nonbelievers in the paranormal'],"['positive-relaxing environments, (2) neutral environments, and (3) negative-stimulating environments']","['altered state of consciousness (ASC) and suggestibility', 'Multivariable Multiaxial Suggestibility Inventory-2 (MMSI-2) scales', 'number of correct answers']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C0150450', 'cui_str': 'Altered state of consciousness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0233423', 'cui_str': 'Suggestibility'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",90.0,0.0340701,The only significant results revealed that mediums obtained a greater number of correct answers than the non-believing participants.,"[{'ForeName': 'Álex', 'Initials': 'Á', 'LastName': 'Escolà-Gascón', 'Affiliation': 'Ramon Llull University, Blanquerna, School of Psychology, Education and Sport Sciences, FPCEE Blanquerna. Electronic address: alexeg@blanquerna.url.edu.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.11.009']
267,33031652,Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19.,"BACKGROUND


Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (Covid-19) on the basis of in vitro activity and data from uncontrolled studies and small, randomized trials.
METHODS


In this randomized, controlled, open-label platform trial comparing a range of possible treatments with usual care in patients hospitalized with Covid-19, we randomly assigned 1561 patients to receive hydroxychloroquine and 3155 to receive usual care. The primary outcome was 28-day mortality.
RESULTS


The enrollment of patients in the hydroxychloroquine group was closed on June 5, 2020, after an interim analysis determined that there was a lack of efficacy. Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15). Consistent results were seen in all prespecified subgroups of patients. The results suggest that patients in the hydroxychloroquine group were less likely to be discharged from the hospital alive within 28 days than those in the usual-care group (59.6% vs. 62.9%; rate ratio, 0.90; 95% CI, 0.83 to 0.98). Among the patients who were not undergoing mechanical ventilation at baseline, those in the hydroxychloroquine group had a higher frequency of invasive mechanical ventilation or death (30.7% vs. 26.9%; risk ratio, 1.14; 95% CI, 1.03 to 1.27). There was a small numerical excess of cardiac deaths (0.4 percentage points) but no difference in the incidence of new major cardiac arrhythmia among the patients who received hydroxychloroquine.
CONCLUSIONS


Among patients hospitalized with Covid-19, those who received hydroxychloroquine did not have a lower incidence of death at 28 days than those who received usual care. (Funded by UK Research and Innovation and National Institute for Health Research and others; RECOVERY ISRCTN number, ISRCTN50189673; ClinicalTrials.gov number, NCT04381936.).",2020,"Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15).","['patients hospitalized with Covid-19, we randomly assigned 1561 patients to receive', 'coronavirus disease 2019 ', 'Hospitalized Patients with Covid-19', 'patients hospitalized with Covid-19']","['hydroxychloroquine', 'hydroxychloroquine and 3155 to receive usual care', 'Hydroxychloroquine and chloroquine', 'Hydroxychloroquine', 'usual care']","['cardiac deaths', 'death', '28-day mortality', 'frequency of invasive mechanical ventilation or death', 'Death', 'incidence of new major cardiac arrhythmia', 'hospital alive']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}]","[{'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2584946', 'cui_str': 'Alive'}]",1561.0,0.344094,"Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Horby', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Mafham', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Bell', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Staplin', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Emberson', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wiselka', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ustianowski', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Einas', 'Initials': 'E', 'LastName': 'Elmahi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Prudon', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Whitehouse', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Felton', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jakki', 'Initials': 'J', 'LastName': 'Faccenda', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Underwood', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'J Kenneth', 'Initials': 'JK', 'LastName': 'Baillie', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Jeffery', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Montgomery', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rowan', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Tarning', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Watson', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa2022926']
268,33303191,Long-term results of a randomized clinical trial of 2 types of ceramic crowns in participants with extensive tooth wear.,"STATEMENT OF PROBLEM


Evidence is sparse regarding the long-term outcomes of restorative treatment of patients with extensive tooth wear.
PURPOSE


The purpose of this long-term prospective randomized clinical trial was to evaluate the performance and success rate of pressed lithium disilicate (LD) and translucent zirconia (TZ) crowns in participants with extensive tooth wear.
MATERIAL AND METHODS


A total of 62 participants with extensive tooth wear (17 women, 45 men; mean age 44.8 years; range 25-63 years) received a total of 713 crowns, LD=362 and TZ=351. Both types of crowns had chamfer preparations and were adhesively luted with dual-polymerizing composite resin cement (PANAVIA F 2.0; Kuraray Noritake Dental Inc). The restorations were clinically reevaluated on average 14, 31, 39, 54, and 65 months after insertion of the crowns according to the modified United States Public Health Service (USPHS) criteria.
RESULTS


After an observation period of up to 6 years, the survival rate for both types of crowns was 99.7%, with 1 lost LD crown after 1 year as a result of loss of retention and 1 lost TZ crown after 3 years because of tooth fracture at the cemento-enamel junction. The success rates were similar for both types of crowns: 98.6% for LD and 99.1% for TZ. Reasons for failures were that 3 participants in each group developed apical lesions, minimal ceramic fractures, or their crowns were rebonded after loss of adhesion. Assessment of color at baseline was significantly different with a better match for LD (84.8% Alfa, 15.2% Bravo) than for TZ crowns (36.5% Alfa, 63.5% Bravo), including TZ crowns with veneered porcelain (P<.001). Secondary caries and cracks did not occur. A post hoc analysis of clinical performance did not indicate any significant differences between extensive tooth wear with primarily mechanical or chemical factors.
CONCLUSIONS


No differences were found between the 2 types of ceramic materials concerning the long-term success and clinical performance, except that TZ crowns were rated by a blinded clinician as less esthetic than LD crowns. The use of high-strength ceramic materials, as well as reliable adhesive bonding, are probably the key factors in the long-term success of ceramic crowns in participants with extensive tooth wear independent of the specific etiology.",2022,"A post hoc analysis of clinical performance did not indicate any significant differences between extensive tooth wear with primarily mechanical or chemical factors.
","['patients with extensive tooth wear', '62 participants with extensive tooth wear (17 women, 45 men; mean age 44.8 years; range 25-63 years) received a total of 713 crowns, LD=362 and TZ=351', 'participants with extensive tooth wear independent of the specific etiology', 'participants with extensive tooth wear']","['ceramic crowns', 'pressed lithium disilicate (LD) and translucent zirconia (TZ) crowns']","['success rates', 'survival rate', 'apical lesions, minimal ceramic fractures', 'performance and success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]","[{'cui': 'C0440171', 'cui_str': 'Dental ceramic crown material'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0010384', 'cui_str': 'Crown'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",62.0,0.208173,"A post hoc analysis of clinical performance did not indicate any significant differences between extensive tooth wear with primarily mechanical or chemical factors.
","[{'ForeName': 'Wedad', 'Initials': 'W', 'LastName': 'Hammoudi', 'Affiliation': 'Assistant professor, Department of Dental Medicine, Karolinska Institutet, Huddinge, Sweden; Specialist in Dental Prosthetics, Department of Prosthetic Dentistry, Folktandvården Eastmaninstitutet, Stockholm, Sweden. Electronic address: wedad.hammoudi@ki.se.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Trulsson', 'Affiliation': 'Professor and Head, Specialist in Dental Prosthetics, Division of Oral Diagnosis and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, Huddinge, Sweden; Professor, Scandinavian Centre for Orofacial Neuroscience (SCON), Huddinge, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Professor and Head, Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus university, Aarhus, Denmark; Professor, Faculty of Odontology, Malmö University, Malmö, Sweden; Professor, Scandinavian Centre for Orofacial Neuroscience (SCON), Huddinge, Sweden.'}, {'ForeName': 'Jan-Ivan', 'Initials': 'JI', 'LastName': 'Smedberg', 'Affiliation': 'Associate professor, Department of Dental Medicine, Karolinska Institutet, Huddinge, Sweden; Specialist in Dental Prosthetics, Department of Prosthetic Dentistry, Folktandvården Eastmaninstitutet, Stockholm, Sweden.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2020.08.041']
269,33288357,Maxillary dental and skeletal effects after treatment with self-ligating appliance and miniscrew-assisted rapid maxillary expansion.,"INTRODUCTION


The objective of the present study was to compare the maxillary dental and skeletal effects after treatment with self-ligating appliance and miniscrew-assisted rapid maxillary expansion (MARPE).
METHODS


The sample comprised 37 patients with Class I malocclusion treated without tooth extraction, divided into 2 groups: group 1 comprises 21 patients with a mean age of 19.55 years (standard deviation = 1.31), submitted to orthodontic treatment with Damon self-ligating appliance, and evaluated until the end of the alignment and leveling stage. Group 2 comprises 16 patients with a mean age of 24.92 years (standard deviation = 7.60), with maxillary atresia, who underwent MARPE, and were evaluated after the removal of the expander. Buccal bone thickness; dental inclinations; and transverse distances of the maxillary arch, nasal base, and jugula widths were measured on cone-beam computed tomography scans before and after treatment. The intergroup comparison was performed with the independent t test.
RESULTS


With treatment, there was a significantly greater decrease in buccal bone thickness of canines and premolars in the self-ligating group, the premolars presented a greater buccal inclination in the self-ligating group, and the intercanine and intermolar distances and nasal base and jugula widths showed significantly greater increases in the MARPE group than in the self-ligating group.
CONCLUSIONS


MARPE treated more severe skeletal transverse maxillary discrepancies and obtained better results than self-ligating appliances in terms of buccal bone loss, tooth inclination, and transverse skeletal increase of the maxilla. MARPE presented more skeletal effects and self-ligating appliances, more dental effects.",2021,", there was a significantly greater decrease in buccal bone thickness of canines and premolars in the self-ligating group, the premolars presented a greater buccal inclination in the self-ligating group, and the intercanine and intermolar distances and nasal base and jugula widths showed significantly greater increases in the MARPE group than in the self-ligating group.
","['16 patients with a mean age of 24.92\xa0years (standard deviation\xa0=\xa07.60), with maxillary atresia, who underwent MARPE, and were evaluated after the removal of the expander', '37 patients with Class I malocclusion treated without tooth extraction, divided into 2 groups: group 1 comprises 21 patients with a mean age of 19.55\xa0years (standard deviation\xa0=\xa01.31), submitted to']","['self-ligating appliance and miniscrew-assisted rapid maxillary expansion', 'orthodontic treatment with Damon self-ligating appliance', 'self-ligating appliance and miniscrew-assisted rapid maxillary expansion (MARPE', 'MARPE']","['severe skeletal transverse maxillary discrepancies', 'Maxillary dental and skeletal effects', 'maxillary dental and skeletal effects', 'buccal inclination', 'buccal bone loss, tooth inclination, and transverse skeletal increase of the maxilla', 'buccal bone thickness', 'transverse distances of the maxillary arch, nasal base, and jugula widths', 'intercanine and intermolar distances and nasal base and jugula widths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0243066', 'cui_str': 'Congenital atresia'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0399523', 'cui_str': 'Malocclusion, Angle class I'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0487742', 'cui_str': 'Width'}]",37.0,0.0268136,", there was a significantly greater decrease in buccal bone thickness of canines and premolars in the self-ligating group, the premolars presented a greater buccal inclination in the self-ligating group, and the intercanine and intermolar distances and nasal base and jugula widths showed significantly greater increases in the MARPE group than in the self-ligating group.
","[{'ForeName': 'Roberta Caetano', 'Initials': 'RC', 'LastName': 'Calil', 'Affiliation': 'Department of Orthodontics, Ingá University Center Uningá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Cecilia Maria', 'Initials': 'CM', 'LastName': 'Marin Ramirez', 'Affiliation': 'Department of Orthodontics, Ingá University Center Uningá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Otazu', 'Affiliation': 'Department of Orthodontics, Advanced Dentistry Institute IOA, Asunción, Paraguay.'}, {'ForeName': 'Dino Marcelo', 'Initials': 'DM', 'LastName': 'Torres', 'Affiliation': 'Department of Orthodontics, Advanced Dentistry Institute IOA, Asunción, Paraguay.'}, {'ForeName': 'Júlio de Araújo', 'Initials': 'JA', 'LastName': 'Gurgel', 'Affiliation': 'Department of Speech Language, São Paulo State University UNESP, Marília, São Paulo, Brazil.'}, {'ForeName': 'Renata Cristina', 'Initials': 'RC', 'LastName': 'Oliveira', 'Affiliation': 'Department of Orthodontics, Ingá University Center Uningá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Ricardo Cesar Gobbi', 'Initials': 'RCG', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Orthodontics, Ingá University Center Uningá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Fabricio Pinelli', 'Initials': 'FP', 'LastName': 'Valarelli', 'Affiliation': 'Department of Orthodontics, Ingá University Center Uningá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Karina Maria Salvatore', 'Initials': 'KMS', 'LastName': 'Freitas', 'Affiliation': 'Department of Orthodontics, Ingá University Center Uningá, Maringá, Paraná, Brazil; Bauru Dental School, University of São Paulo, Bauru, São Paulo, Brazil. Electronic address: kmsf@uol.com.br.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2020.09.011']
270,33290616,"Safety and Pharmacokinetics of the Oral TYK2 Inhibitor PF-06826647: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study.","Selective inhibition of tyrosine kinase 2 (TYK2) may offer therapeutic promise in inflammatory conditions, with its role in downstream pro-inflammatory cytokine signaling. In this first-in-human study, we evaluated the safety, tolerability, and pharmacokinetics (PK) of a novel TYK2 inhibitor, PF-06826647, in healthy participants. This phase I, randomized, double-blind, placebo-controlled, parallel-group study included two treatment periods (single ascending dose (SAD) and multiple ascending dose (MAD)) in healthy participants and a cohort of healthy Japanese participants receiving 400 mg q.d. or placebo in the MAD period (NCT03210961). Participants were randomly assigned to PF-06826647 or placebo (3:1). Participants received a single oral study drug dose of 3, 10, 30, 100, 200, 400, or 1,600 mg (SAD period), then 30, 100, 400, or 1,200 mg q.d. or 200 mg b.i.d. for 10 days (MAD period). Safety (adverse events (AEs), vital signs, and clinical laboratory parameters), tolerability, and PK were assessed. Overall, 69 participants were randomized to treatment, including six Japanese participants. No deaths, serious AEs, severe AEs, or AEs leading to dose reduction or temporary/permanent discontinuation were observed. All AEs were mild in severity. No clinically relevant laboratory abnormalities or changes in vital signs were detected. PF-06826647 was rapidly absorbed with a median time to maximum plasma concentration of 2 hours in a fasted state, with modest accumulation (< 1.5-fold) after multiple dosing and low urinary recovery. PF-06826647 was well-tolerated, with an acceptable safety profile for doses up to 1,200 mg q.d. for 10 days, supporting further testing in patients.",2021,"PF-06826647 was well-tolerated, with an acceptable safety profile for doses up to 1,200 mg q.d.","['healthy participants and a cohort of healthy Japanese participants receiving 400\xa0mg q.d. or', '69 participants were randomized to treatment, including six Japanese participants', 'healthy participants']","['Oral TYK2', 'Inhibitor PF-06826647', 'placebo', 'ascending dose (SAD) and multiple ascending dose (MAD', 'Placebo']","['No deaths, serious AEs, severe AEs, or AEs leading to dose reduction or temporary/permanent discontinuation', 'Safety (adverse events (AEs), vital signs, and clinical laboratory parameters), tolerability, and PK', 'safety, tolerability, and pharmacokinetics (PK']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1706299', 'cui_str': 'Tyrosine Kinase 2'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",69.0,0.621233,"PF-06826647 was well-tolerated, with an acceptable safety profile for doses up to 1,200 mg q.d.","[{'ForeName': 'Ravi Shankar P', 'Initials': 'RSP', 'LastName': 'Singh', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Pradhan', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Erika S', 'Initials': 'ES', 'LastName': 'Roberts', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Scaramozza', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kieras', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Gale', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Peeva', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Vincent', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Anindita', 'Initials': 'A', 'LastName': 'Banerjee', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fensome', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Dowty', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Winkle', 'Affiliation': 'Anaheim Clinical Trials, Anaheim, California, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Tehlirian', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}]",Clinical and translational science,['10.1111/cts.12929']
271,33297893,The multiarm optimization of stroke thrombolysis phase 3 acute stroke randomized clinical trial: Rationale and methods.,"BACKGROUND


Intravenous recombinant tissue plasminogen activator is the only proven effective medication for the treatment of acute ischemic stroke. Two approaches that may augment recombinant tissue plasminogen activator thrombolysis and prevent arterial reocclusion are direct thrombin inhibition with argatroban and inhibition of the glycoprotein 2b/3a receptor with eptifibatide.
AIM


The multi-arm optimization of stroke thrombolysis trial aims to determine the safety and efficacy of intravenous therapy with argatroban or eptifibatide as compared with placebo in acute ischemic stroke patients treated with intravenous recombinant tissue plasminogen activator within 3 h of symptom onset.
SAMPLE SIZE ESTIMATE


A maximum of 1200 randomized subjects to test the superiority of argatroban or eptifibatide to placebo in improving 90-day modified Rankin scores.
METHODS AND DESIGN


Multiarm optimization of stroke thrombolysis is a multicenter, multiarm, adaptive, single blind, randomized controlled phase 3 clinical trial conducted within the National Institutes of Health StrokeNet clinical trial network. Patients treated with 0.9 mg/kg intravenous recombinant tissue plasminogen activator within 3 h of stroke symptom onset are randomized to receive intravenous argatroban (100 µg/kg bolus followed by 3 µg/kg/min for 12 h), intravenous eptifibatide (135 µg/kg bolus followed by 0.75 µg/kg/min infusion for 2 h) or IV placebo. Patients may receive endovascular thrombectomy per usual care.
STUDY OUTCOMES


The primary efficacy outcome is improved modified Rankin score assessed at 90 days post-randomization.
DISCUSSION


Multiarm optimization of stroke thrombolysis is an innovative and collaborative project that is the culmination of many years of dedicated efforts to improve outcomes for stroke patients.",2021,"A maximum of 1200 randomized subjects to test the superiority of argatroban or eptifibatide to placebo in improving 90-day modified Rankin scores.
","['acute ischemic stroke patients treated with', 'stroke patients']","['glycoprotein', 'recombinant tissue plasminogen activator', 'endovascular thrombectomy per usual care', 'placebo', 'intravenous eptifibatide', 'intravenous argatroban', 'eptifibatide', 'intravenous recombinant tissue plasminogen activator', 'argatroban or eptifibatide to placebo', 'argatroban or eptifibatide']","['modified Rankin score assessed at 90 days post-randomization', 'safety and efficacy', '90-day modified Rankin scores']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0253563', 'cui_str': 'eptifibatide'}, {'cui': 'C0048470', 'cui_str': 'argatroban'}]","[{'cui': 'C3888574', 'cui_str': 'Modified Rankin score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1200.0,0.380895,"A maximum of 1200 randomized subjects to test the superiority of argatroban or eptifibatide to placebo in improving 90-day modified Rankin scores.
","[{'ForeName': 'S Iris', 'Initials': 'SI', 'LastName': 'Deeds', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Barreto', 'Affiliation': 'Department of Neurology, University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Elm', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Colin P', 'Initials': 'CP', 'LastName': 'Derdeyn', 'Affiliation': 'Department of Radiology, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC., Austin, TX, USA.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Khatri', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Moy', 'Affiliation': '35046National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Janis', 'Affiliation': '35046National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Broderick', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, OH, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Grotta', 'Affiliation': 'Memorial Hermann Hospital - Texas Medical Center, Houston, TX, USA.'}, {'ForeName': 'Opeolu', 'Initials': 'O', 'LastName': 'Adeoye', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati, Cincinnati, OH, USA.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020978345']
272,33297739,"Seasonal flu vaccination, a matter of emotion? An experimental study on role of compassion, socioeconomic status and perceived threat among healthcare workers.","OBJECTIVE


This study tests the impact of threat on compassion and vaccination intention among healthcare workers (HCWs) with low and high socio-economic status (SES) in France.
DESIGN


A total of 309 HCWs were analyzed ( M age =39.29,  SD  = 11.76). Participants with high ( n  = 138) or low ( n  = 171) SES were randomly assigned to a Threat ( n  = 187) versus a No-Threat ( n  = 122) condition through filling in MacArthur's scale. During this manipulation, participants read about an interaction involving a HCW with an SES higher than that of the participant. After filling in the MacArthur scale, all participants went through a compassion manipulation. Finally, participants read a text describing a patient's distress.
MAIN OUTCOME MEASURES


The primary outcome was the vaccination intention score. The secondary outcome included the compassion score.
RESULTS


The interaction of the Group X SES Subjective on compassion was not significant ( p  = .34,  η p 2  = .003, 95%CI [-.39,.07]). The interaction of the Group X Diploma on vaccination intention with high compassion was significant ( p <.001,  η p 2  = .173, 95%CI [.11,1.68]). Planned comparisons revealed a significant difference in vaccination intention score between HCWs with low SES between Threat ( M  = 3.58,  SD  = 2.56) and No-Threat ( M  = 5.27,  SD  = 2.27;  p =.01) conditions.
CONCLUSION


Ultimately, compassion inhibited the distress elicited in the threat condition in HCWs with high compassion.",2021,"The interaction of the Group X Diploma on vaccination intention with high compassion was significant ( p <.001,  η p   2  = .173, 95%CI","['healthcare workers', 'Participants with high ( n \u2009=\u2009138) or low ( n \u2009=\u2009171) SES', 'healthcare workers (HCWs) with low and high socio-economic status (SES) in France']","['95%CI', ""No-Threat ( n \u2009=\u2009122) condition through filling in MacArthur's scale""]","['vaccination intention score', 'compassion score']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",309.0,0.179383,"The interaction of the Group X Diploma on vaccination intention with high compassion was significant ( p <.001,  η p   2  = .173, 95%CI","[{'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Bodelet', 'Affiliation': 'Psychology, Grenoble-Alpes University, Savoie Mont Blanc University, Grenoble, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Bodelet', 'Affiliation': 'Research Center for Statistics, Geneva School of Economics and Management, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Landelle', 'Affiliation': 'Public Infection Control Unit, TIMC-IMAG, Grenoble Alpes University Hospital and Grenoble Alpes University, CNRS, Grenoble INP, Grenoble, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Gauchet', 'Affiliation': 'Psychology, Grenoble-Alpes University, Savoie Mont Blanc University, Grenoble, France.'}]",Psychology & health,['10.1080/08870446.2020.1856843']
273,33297730,An exploratory clinical trial on acceptance and commitment therapy as an adjunct to psychoeducational relaxation therapy for chronic pain.,"Objective:  The aim of this study was to compare the clinical efficacy of two differently-designed psychological interventions for chronic pain. Design:  138 patients presenting chronic pain were randomly assigned to one of two experimental conditions: (1) Psychoeducational relaxation therapy (PRT, n   =   84) or (2) PRT followed by acceptance and commitment therapy (PRT + ACT, n   =   54). Main outcome measures:  Pain intensity, quality of life (SF-36), anxiety and depression (HADS), stress (PSS), pain catastrophizing (PCS), chronic pain acceptance (CPAQ), and psychological inflexibility (PIPS) were assessed at three time-points: before therapy (T1); at the end of the therapy (T2); and 3- months after the end of the therapy (T3). Results:  In T2, the PRT intervention showed more significant improvements in the measures of mental quality of life [F (1,92) = 7.478,  P <  .05] and depression [F (1, 92) = 5.804,  P  < .05] compared to the PRT + ACT intervention. The experimental groups did not differ in their outcome measures at T3. Conclusion:  PRT appears to be an effective solution in the psychological care of chronic pain. The effectiveness of this type of intervention seems to have been underestimated. The addition of ACT sessions did not significantly impact the results, indicating that both designs of interventions are effective in the short term.",2021,"In T2, the PRT intervention showed more significant improvements in the measures of mental quality of life [F (1,92) =","['chronic pain', '138 patients presenting chronic pain']","['Psychoeducational relaxation therapy (PRT, n \u2009 = \u2009 84) or (2) PRT followed by acceptance and commitment therapy (PRT\u2009+\u2009ACT, n \u2009 = \u2009 54', 'psychoeducational relaxation therapy', 'PRT', 'PRT intervention', 'psychological interventions']","['Pain intensity, quality of life (SF-36), anxiety and depression (HADS), stress (PSS), pain catastrophizing (PCS), chronic pain acceptance (CPAQ), and psychological inflexibility (PIPS', 'clinical efficacy', 'mental quality of life']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0020687', 'cui_str': 'Hypoxanthine phosphoribosyltransferase'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",138.0,0.0812759,"In T2, the PRT intervention showed more significant improvements in the measures of mental quality of life [F (1,92) =","[{'ForeName': 'Tamila', 'Initials': 'T', 'LastName': 'Roslyakova', 'Affiliation': 'Epsylon EA4556, Dynamic of Human Abilities and Health Behaviors, University of Paul Valery Montpellier 3, Montpellier, France.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Falco', 'Affiliation': 'Private Practice, Grenoble, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Gauchet', 'Affiliation': 'Inter-University Psychology Laboratory, University Grenoble Alpes, Grenoble, France.'}]",Psychology & health,['10.1080/08870446.2020.1856844']
274,33307444,Association between social isolation and outpatient follow-up in older adults following emergency department discharge.,"OBJECTIVES


Follow-up with outpatient clinicians after discharge from the emergency department (ED) reduces adverse outcomes among older adults, but rates are suboptimal. Social isolation, a common factor associated with poor health outcomes, may help explain these low rates. This study evaluates social isolation as a predictor of outpatient follow-up after discharge from the ED.
MATERIALS AND METHODS


This cohort study uses the control group from a randomized-controlled trial investigating a community paramedic-delivered Care Transitions Intervention with older patients (age≥60 years) at three EDs in mid-sized cities. Social Isolation scores were measured at baseline using the PROMIS 4-item social isolation questionnaire, grouped into tertiles for analysis. Chart abstraction was conducted to identify follow-up with outpatient primary or specialty healthcare providers and method of contact within 7 and 30 days of discharge.
RESULTS


Of 642 patients, highly socially-isolated adults reported significantly worse overall health, as well as increased anxiety, depressive symptoms, functional limitations, and co-morbid conditions compared to those less socially-isolated (p<0.01). We found no effect of social isolation on 30-day follow-up. Patients with high social isolation, however, were 37% less likely to follow-up with a provider in-person within 7 days of ED discharge compared to low social isolation (OR:0.63, 95% CI:0.42-0.96).
CONCLUSION


This study adds to our understanding of how and when socially-isolated older adults seek outpatient care following ED discharge. Increased social isolation was not significantly associated with all-contact follow-up rates after ED discharge. However, patients reporting higher social isolation had lower rates of in-person follow-up in the week following ED discharge.",2021,"However, patients reporting higher social isolation had lower rates of in-person follow-up in the week following ED discharge.","['with older patients (age≥60 years) at three EDs in mid-sized cities', 'older adults', '642 patients, highly socially-isolated adults', 'socially-isolated older adults seek outpatient care following ED discharge', 'older adults following emergency department discharge']",['community paramedic-delivered Care Transitions Intervention'],"['low social isolation', 'overall health', 'Increased social isolation', 'Social Isolation scores', 'anxiety, depressive symptoms, functional limitations, and co-morbid conditions']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}]",642.0,0.0490657,"However, patients reporting higher social isolation had lower rates of in-person follow-up in the week following ED discharge.","[{'ForeName': 'Nia A', 'Initials': 'NA', 'LastName': 'Cayenne', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Gwen Costa', 'Initials': 'GC', 'LastName': 'Jacobsohn', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States. Electronic address: gjacobsohn@wisc.edu.'}, {'ForeName': 'Courtney M C', 'Initials': 'CMC', 'LastName': 'Jones', 'Affiliation': 'Department of Emergency Medicine, University of Rochester Medical Center, Rochester, NY, United States; Department of Public Health Sciences, University of Rochester Medical Center, Rochester, NY, United States.'}, {'ForeName': 'Eva H', 'Initials': 'EH', 'LastName': 'DuGoff', 'Affiliation': 'Department of Health Policy and Management, School of Public Health, University of Maryland, College Park, MD, United States; Department of Population Health Sciences, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, United States; Berkeley Research Group, Washington, DC, United States.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Cochran', 'Affiliation': 'Department of Population Health Sciences, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Caprio', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of Rochester Medical Center, Rochester, NY, United States.'}, {'ForeName': 'Jeremy T', 'Initials': 'JT', 'LastName': 'Cushman', 'Affiliation': 'Department of Emergency Medicine, University of Rochester Medical Center, Rochester, NY, United States; Department of Public Health Sciences, University of Rochester Medical Center, Rochester, NY, United States.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Green', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Amy J H', 'Initials': 'AJH', 'LastName': 'Kind', 'Affiliation': 'Division of Geriatrics and Gerontology, Department of Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States; William S. Middleton Veterans Affairs Geriatrics Research, Education, and Clinical Center, Madison, WI, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lohmeier', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Ranran', 'Initials': 'R', 'LastName': 'Mi', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Manish N', 'Initials': 'MN', 'LastName': 'Shah', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States; Department of Population Health Sciences, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, United States; Division of Geriatrics and Gerontology, Department of Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104298']
275,33309466,Breathing therapy and emotional freedom techniques on public speaking anxiety in Turkish nursing students: A randomized controlled study.,"BACKGROUND AND OBJECTIVE


Public speaking is a common challenge that university students have to face. This study aims to determine the effects of Breathing Therapy and Emotional Freedom Techniques (EFT) on public speaking anxiety in Turkish nursing students.
METHODS


This randomized controlled study included 76 nursing students. Data were collected using the Descriptive Characteristics Form, Subjective Units of Disturbance Scale, The State-Trait Anxiety Inventory, and the Speech Anxiety Scale.
RESULTS


Before the administration of Breathing Therapy and EFT, the students' median scores from the Subjective Units of Disturbance Scale, the State-Trait Anxiety Inventory, and the Speech Anxiety Scale were similar. However, the median scores of the Subjective Units of Disturbance Scale, the State-Trait Anxiety Inventory, and the Speech Anxiety Scale scores significantly decreased in both of the experimental groups after the interventions (p <0.001). EFT (d = 3.18) was more effective than Breathing Therapy (d = 1.46) in reducing Speech anxiety.
CONCLUSION


It was found that Breathing Therapy and EFT are effective methods to reduce stress, anxiety, and speaking anxiety.",2022,"d = 3.18) was more effective than Breathing Therapy (d = 1.46) in reducing Speech anxiety.
","['76 nursing students', 'public speaking anxiety in Turkish nursing students', 'university students', 'Turkish nursing students']","['EFT ', 'Breathing Therapy and Emotional Freedom Techniques (EFT', 'Breathing therapy and emotional freedom techniques']","['Descriptive Characteristics Form, Subjective Units of Disturbance Scale, The State-Trait Anxiety Inventory, and the Speech Anxiety Scale', 'stress, anxiety, and speaking anxiety', 'median scores of the Subjective Units of Disturbance Scale, the State-Trait Anxiety Inventory, and the Speech Anxiety Scale scores', 'public speaking anxiety', 'Speech anxiety', 'Subjective Units of Disturbance Scale, the State-Trait Anxiety Inventory, and the Speech Anxiety Scale']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0424169', 'cui_str': 'Fear of public speaking'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",76.0,0.0286143,"d = 3.18) was more effective than Breathing Therapy (d = 1.46) in reducing Speech anxiety.
","[{'ForeName': 'Berna', 'Initials': 'B', 'LastName': 'Dincer', 'Affiliation': 'Istanbul Medeniyet University, Faculty of Health Sciences, Department of Nursing, Istanbul, Turkey. Electronic address: berna.dincer@medeniyet.edu.tr.'}, {'ForeName': 'Semanur Kumral', 'Initials': 'SK', 'LastName': 'Özçelik', 'Affiliation': 'Marmara University, Faculty of Health Sciences, Department of Nursing, Istanbul, Turkey.'}, {'ForeName': 'Zülfünaz', 'Initials': 'Z', 'LastName': 'Özer', 'Affiliation': 'Istanbul Sabahattin Zaim University, Faculty of Health Sciences, Department of Nursing, Istanbul, Turkey.'}, {'ForeName': 'Nefise', 'Initials': 'N', 'LastName': 'Bahçecik', 'Affiliation': 'Istanbul Sabahattin Zaim University, Faculty of Health Sciences, Department of Nursing, Istanbul, Turkey.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.11.006']
276,33306989,"Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.","BACKGROUND


A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials.
METHODS


This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 10 10  viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674.
FINDINGS


Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; p interaction =0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation.
INTERPRETATION


ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials.
FUNDING


UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.",2021,Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829).,"['Participants aged 18 years and older', 'Between April 23 and Nov 4, 2020', ' 23\u2008848 participants were enrolled and 11\u2008636 participants (7548 in the UK, 4088 in Brazil']","['vaccine', 'ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2', 'ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline', 'ChAdOx1 nCoV-19 vaccine']","['vaccine efficacy', 'severe adverse events', 'safety and efficacy', 'Vaccine efficacy', 'Overall vaccine efficacy', 'Safety and efficacy']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",23848.0,0.446829,Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829).,"[{'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sue Ann Costa', 'Initials': 'SAC', 'LastName': 'Clemens', 'Affiliation': 'Institute of Global Health, University of Siena, Siena, Brazil; Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'MRC Vaccines and Infectious Diseases Analytics Research Unit, Johannesburg, South Africa.'}, {'ForeName': 'Lily Y', 'Initials': 'LY', 'LastName': 'Weckx', 'Affiliation': 'Department of Pediatrics, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Parvinder K', 'Initials': 'PK', 'LastName': 'Aley', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Angus', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Vicky L', 'Initials': 'VL', 'LastName': 'Baillie', 'Affiliation': 'Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Shaun L', 'Initials': 'SL', 'LastName': 'Barnabas', 'Affiliation': 'Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch, Cape Town, South Africa.'}, {'ForeName': 'Qasim E', 'Initials': 'QE', 'LastName': 'Bhorat', 'Affiliation': 'Soweto Clinical Trials Centre, Soweto, South Africa.'}, {'ForeName': 'Sagida', 'Initials': 'S', 'LastName': 'Bibi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Briner', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cicconi', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Collins', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine and Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Colin-Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Darton', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK; Department of Infection and Tropical Medicine, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Keertan', 'Initials': 'K', 'LastName': 'Dheda', 'Affiliation': 'Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town, South Africa; Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Christopher J A', 'Initials': 'CJA', 'LastName': 'Duncan', 'Affiliation': 'Department of Infection and Tropical Medicine, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Translational and Clinical Research Institute, Immunity and Inflammation Theme, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Katherine R W', 'Initials': 'KRW', 'LastName': 'Emary', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katie J', 'Initials': 'KJ', 'LastName': 'Ewer', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniela M', 'Initials': 'DM', 'LastName': 'Ferreira', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine and Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Finn', 'Affiliation': 'School of Population Health Sciences, University of Bristol and University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Goodman', 'Affiliation': ""Department of Infection, Guy's and St Thomas' NHS Foundation Trust, St Thomas' Hospital, London, UK; MRC Clinical Trials Unit, University College London, London, UK.""}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Green', 'Affiliation': 'Clinical BioManufacturing Facility, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Green', 'Affiliation': 'NIHR/Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Heath', 'Affiliation': ""St George's Vaccine Institute, St George's, University of London, London, UK.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine and Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Hirsch', 'Affiliation': 'AstraZeneca BioPharmaceuticals, Cambridge, UK.'}, {'ForeName': 'Susanne H C', 'Initials': 'SHC', 'LastName': 'Hodgson', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Alane', 'Initials': 'A', 'LastName': 'Izu', 'Affiliation': 'VIDA-Vaccines and Infectious Diseases Analytical Research Unit, Johannesburg, South Africa.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jackson', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jenkin', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Carina C D', 'Initials': 'CCD', 'LastName': 'Joe', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kerridge', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Anthonet', 'Initials': 'A', 'LastName': 'Koen', 'Affiliation': 'VIDA-Vaccines and Infectious Diseases Analytical Research Unit, Johannesburg, South Africa.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Kwatra', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Rajeka', 'Initials': 'R', 'LastName': 'Lazarus', 'Affiliation': 'Severn Pathology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Lawrie', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Lelliott', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Libri', 'Affiliation': 'NIHR UCLH Clinical Research Facility and NIHR UCLH Biomedical Research Centre, London, UK.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Lillie', 'Affiliation': 'Department of Infection, Hull University Teaching Hospitals NHS Trust, UK.'}, {'ForeName': 'Raburn', 'Initials': 'R', 'LastName': 'Mallory', 'Affiliation': 'AstraZeneca BioPharmaceuticals, Cambridge, UK.'}, {'ForeName': 'Ana V A', 'Initials': 'AVA', 'LastName': 'Mendes', 'Affiliation': ""Escola Bahiana de Medicina e Saúde Pública, Salvador, Braziland Hospital São Rafael, Salvador, Brazil; Instituto D'Or, Salvador, Brazil.""}, {'ForeName': 'Eveline P', 'Initials': 'EP', 'LastName': 'Milan', 'Affiliation': 'Department of Infectious Diseases, Universidade Federal do Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Minassian', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'McGregor', 'Affiliation': 'London Northwest University Healthcare, Harrow, UK.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Morrison', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Yama F', 'Initials': 'YF', 'LastName': 'Mujadidi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'Nana', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Reilly"", 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sherman D', 'Initials': 'SD', 'LastName': 'Padayachee', 'Affiliation': 'Setshaba Research Centre, Pretoria, South Africa.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pittella', 'Affiliation': ""Department of Internal Medicine, Hospital Quinta D'Or, Rio de Janeiro, Brazil; Instituto D'Or de Pesquisa e Ensino (IDOR), Rio de Janeiro, Brazil; Department of Internal Medicine, Universidade UNIGRANRIO, Rio de Janeiro, Brazil.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Plested', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katrina M', 'Initials': 'KM', 'LastName': 'Pollock', 'Affiliation': 'NIHR Imperial Clinical Research Facility and NIHR Imperial Biomedical Research Centre, London, UK.'}, {'ForeName': 'Maheshi N', 'Initials': 'MN', 'LastName': 'Ramasamy', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rhead', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexandre V', 'Initials': 'AV', 'LastName': 'Schwarzbold', 'Affiliation': 'Clinical Research Unit, Department of Clinical Medicine, Universidade Federal de Santa Maria, Santa Maria, Brazil.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'College of Medical, Veterinary & Life Sciences, Glasgow Dental Hospital & School, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Rinn', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': ""Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; Division of Infectious Diseases, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sprinz', 'Affiliation': 'Infectious Diseases Service, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Sutherland', 'Affiliation': 'Clinical Infection Research Group, Regional Infectious Diseases Unit, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Tarrant', 'Affiliation': 'Clinical BioManufacturing Facility, University of Oxford, Oxford, UK.'}, {'ForeName': 'Emma C', 'Initials': 'EC', 'LastName': 'Thomson', 'Affiliation': 'MRC-University of Glasgow Centre for Virus Research & Department of Infectious Diseases, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'M Estée', 'Initials': 'ME', 'LastName': 'Török', 'Affiliation': 'Department of Medicine, University of Cambridge, UK; Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Toshner', 'Affiliation': 'Heart Lung Research Institute, Department of Medicine, University of Cambridge and Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'David P J', 'Initials': 'DPJ', 'LastName': 'Turner', 'Affiliation': 'University of Nottingham and Nottingham University Hospitals NHS Trust, UK.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vekemans', 'Affiliation': 'AstraZeneca BioPharmaceuticals, Cambridge, UK.'}, {'ForeName': 'Tonya L', 'Initials': 'TL', 'LastName': 'Villafana', 'Affiliation': 'AstraZeneca BioPharmaceuticals, Cambridge, UK.'}, {'ForeName': 'Marion E E', 'Initials': 'MEE', 'LastName': 'Watson', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Williams', 'Affiliation': 'Public Health Wales, Cardiff, Wales; Aneurin Bevan University Health Board, Newport, UK.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Douglas', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Adrian V S', 'Initials': 'AVS', 'LastName': 'Hill', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Gilbert', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK. Electronic address: andrew.pollard@paediatrics.ox.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32661-1']
277,33340120,Effects of mexiletine on hyperexcitability in sporadic amyotrophic lateral sclerosis: Preliminary findings from a small phase II randomized controlled trial.,"BACKGROUND


To collect preliminary data on the effects of mexiletine on cortical and axonal hyperexcitability in sporadic amyotrophic lateral sclerosis (ALS) in a phase 2 double-blind randomized controlled trial.
METHODS


Twenty ALS subjects were randomized to placebo and mexiletine 300 or 600 mg daily for 4 wk and assessed by transcranial magnetic stimulation and axonal excitability studies. The primary endpoint was change in resting motor threshold (RMT).
RESULTS


RMT was unchanged with 4 wk of mexiletine (combined active therapies) as compared to placebo, which showed a significant increase (P = .039). Reductions of motor evoked potential (MEP) amplitude (P = .013) and accommodation half-time (P = .002), secondary outcome measures of cortical and axonal excitability, respectively, were also evident at 4 wk on mexiletine.
CONCLUSIONS


The relative stabilization of RMT in the treated subjects was unexpected and could be attributed to unaccounted sources of error or chance. However, a possible alternative cause is neuromodulation preventing an increase. The change in MEP amplitude and accommodation half-time supports the reduction of cortical and axonal hyperexcitability with mexiletine.",2021,"Reductions of motor evoked potential (MEP) amplitude (p=0.013) and accommodation half-time (p=0.002), secondary outcome measures of cortical and axonal excitability, respectively, were also evident at 4 weeks on mexiletine.
","['Twenty ALS subjects', 'Sporadic ALS', 'sporadic amyotrophic lateral sclerosis (ALS']","['Mexiletine', 'mexiletine', 'placebo and mexiletine', 'placebo']","['change in resting motor threshold (RMT', 'Reductions of motor evoked potential (MEP) amplitude', 'relative stabilization of RMT', 'cortical and axonal excitability']","[{'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C1862941', 'cui_str': 'Amyotrophic Lateral Sclerosis, Sporadic'}]","[{'cui': 'C0025887', 'cui_str': 'Mexiletine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",20.0,0.487314,"Reductions of motor evoked potential (MEP) amplitude (p=0.013) and accommodation half-time (p=0.002), secondary outcome measures of cortical and axonal excitability, respectively, were also evident at 4 weeks on mexiletine.
","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Weiss', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Department of Medicine, Biostatistics Center, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Courtney E', 'Initials': 'CE', 'LastName': 'McIlduff', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Vucic', 'Affiliation': 'Department of Neurology, Royal Prince Alfred Hospital; and the Brain and Mind Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Wainger', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Kiernan', 'Affiliation': 'Department of Neurology, Royal Prince Alfred Hospital; and the Brain and Mind Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Goutman', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Namita A', 'Initials': 'NA', 'LastName': 'Goyal', 'Affiliation': 'Department of Neurology, University of California, Irvine, California, USA.'}, {'ForeName': 'Seward B', 'Initials': 'SB', 'LastName': 'Rutkove', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Shafeeq S', 'Initials': 'SS', 'LastName': 'Ladha', 'Affiliation': 'Department of Neurology, Barrow Neurological Institute, Phoenix, Arizona, USA.'}, {'ForeName': 'I-Hweii Amy', 'Initials': 'IA', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Harms', 'Affiliation': 'Department of Neurology, Columbia University, New York, New York, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brannagan', 'Affiliation': 'Department of Neurology, Columbia University, New York, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lacomis', 'Affiliation': 'Department of Neurology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Zivkovic', 'Affiliation': 'Department of Neurology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Leo H', 'Initials': 'LH', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Simmons', 'Affiliation': 'Department of Neurology, Penn State University, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Rivner', 'Affiliation': 'Department of Neurology, Augusta University, Augusta, Georgia, USA.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Shefner', 'Affiliation': 'Department of Neurology, Barrow Neurological Institute, Phoenix, Arizona, USA.'}, {'ForeName': 'Merit E', 'Initials': 'ME', 'LastName': 'Cudkowicz', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Nazem', 'Initials': 'N', 'LastName': 'Atassi', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Muscle & nerve,['10.1002/mus.27146']
278,33331088,MR Measures of Small Bowel Wall T2 Are Associated With Increased Permeability.,"BACKGROUND


Increased small bowel permeability leads to bacterial translocation, associated with significant morbidity and mortality. Biomarkers are needed to evaluate these changes in vivo, stratify an individual's risk, and evaluate the efficacy of interventions. MRI is an established biomarker of small bowel inflammation.
PURPOSE


To characterize changes in the small bowel with quantitative MRI measures associated with increased permeability induced by indomethacin.
STUDY TYPE


Prospective single-center, double-blind, two-way crossover provocation study.
SUBJECTS


A provocation cohort (22 healthy volunteers) and intrasubject reproducibility cohort (8 healthy volunteers).
FIELD STRENGTH/SEQUENCE


2D balanced turbo field echo sequences to measure small bowel wall thickness, T 2  , and motility acquired at 3T.
ASSESSMENT


Participants were randomized to receive indomethacin or placebo prior to assessment. After a minimum 2-week washout, measures were repeated with the alternative allocation. MR measures (wall thickness, T 2  , motility) at each study visit were compared to the reference standard 2-hour lactulose/mannitol urinary excretion ratio (LMR) test performed by a lab technician. All analyses were performed blind.
STATISTICAL TESTS


Normality was tested (Shapiro-Wilk's test). Paired testing (Student's t-test or Wilcoxon) determined the significance of paired differences with indomethacin provocation. Pearson's correlation coefficient compared significant measures with indomethacin provocation to LMR. Intrasubject (intraclass correlation) and interrater variability (Bland-Altman) were assessed.
RESULTS


Indomethacin provocation induced a significant increase in LMR compared to placebo (P < 0.05) and a significant increase in small bowel T 2  (0.12 seconds compared to placebo 0.07 seconds, P < 0.05). Small bowel wall thickness (P = 0.17) and motility (P = 0.149) showed no significant change. T 2  and LMR were positively correlated (r = 0.68, P < 0.05). T 2  measurements were robust to interobserver (intraclass correlation 0.89) and intrasubject variability (Bland-Altman bias of 0.005 seconds, 95% confidence interval [CI] -0.04 to +0.05 seconds, and 0.0006 seconds, 95% CI -0.05 to +0.06 seconds).
DATA CONCLUSION


MR measures of small bowel wall T 2  were significantly increased following indomethacin provocation and correlated with 2-hour LMR test results.
LEVEL OF EVIDENCE


1 TECHNICAL EFFICACY STAGE: 2.",2021,Small bowel wall thickness (P = 0.17) and motility (P = 0.149) showed no significant change.,['A provocation cohort (22 healthy volunteers) and intrasubject reproducibility cohort (8 healthy volunteers'],"['indomethacin', 'indomethacin or placebo', 'placebo']","['interrater variability (Bland-Altman', 'MR measures of small bowel wall T 2', 'Small bowel wall thickness', 'motility', 'small bowel T 2', 'MR measures (wall thickness, T 2  , motility', 'LMR', 'mannitol urinary excretion ratio (LMR) test', 'T 2  and LMR', 'intrasubject variability']","[{'cui': 'C0449428', 'cui_str': 'Provocation'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",22.0,0.0537468,Small bowel wall thickness (P = 0.17) and motility (P = 0.149) showed no significant change.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Scott', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Hannah G', 'Initials': 'HG', 'LastName': 'Williams', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Caroline L', 'Initials': 'CL', 'LastName': 'Hoad', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alyami', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Ortori', 'Affiliation': 'Centre for Analytical Bioscience, School of Pharmacy, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jane I', 'Initials': 'JI', 'LastName': 'Grove', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Marciani', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Gordon W', 'Initials': 'GW', 'LastName': 'Moran', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Robin C', 'Initials': 'RC', 'LastName': 'Spiller', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Menys', 'Affiliation': 'Motilent Ltd, London, UK.'}, {'ForeName': 'Guruprasad P', 'Initials': 'GP', 'LastName': 'Aithal', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Penny A', 'Initials': 'PA', 'LastName': 'Gowland', 'Affiliation': 'National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre at the Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27463']
279,33333147,Estimated GFR Variability and Risk of Cardiovascular Events and Mortality in SPRINT (Systolic Blood Pressure Intervention Trial).,"RATIONALE AND OBJECTIVE


Although low estimated glomerular filtration rate (eGFR) is associated with cardiovascular disease (CVD) events and mortality, the clinical significance of variability in eGFR over time is uncertain. This study aimed to evaluate the associations between variability in eGFR and the risk of CVD events and all-cause mortality.
STUDY DESIGN


Longitudinal analysis of clinical trial participants.
SETTINGS AND PARTICIPANTS


7,520 Systolic Blood Pressure Intervention Trial (SPRINT) participants ≥50 year of age with 1 or more CVD risk factors.
PREDICTORS


eGFR variability, estimated by the coefficient of variation of eGFR assessments at the 6th, 12th, and 18-month study visits.
OUTCOMES


The SPRINT primary CVD composite outcome (myocardial infarction, acute coronary syndrome, stroke, heart failure, or CVD death) and all-cause mortality from month 18 to the end of follow-up.
ANALYTICAL APPROACH


Cox models were used to evaluate associations between eGFR variability and CVD outcomes and all-cause mortality. Models were adjusted for demographics, randomization arm, CVD risk factors, albuminuria, and eGFR at month 18.
RESULTS


Mean age was 68 ± 9 years; 65% were men; and 58% were White. The mean eGFR was 73 ± 21 (SD) mL/min/1.73 m 2  at 6 months. There were 370 CVD events and 154 deaths during a median follow-up of 2.4 years. Greater eGFR variability was associated with higher risk for all-cause mortality (hazard ratio [HR] per 1 SD greater variability, 1.29; 95% CI, 1.14-1.45) but not CVD events (HR, 1.05; 95% CI, 0.95-1.16) after adjusting for albuminuria, eGFR, and other CVD risk factors. Associations were similar when stratified by treatment arm and by baseline CKD status, when accounting for concurrent systolic blood pressure changes, use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and diuretic medications during follow up.
LIMITATIONS


Persons with diabetes and proteinuria > 1 g/d were excluded.
CONCLUSIONS


In trial participants at high risk for CVD, greater eGFR variability was independently associated with all-cause mortality but not CVD events.",2021,The mean eGFR was 73±21,"['Persons with diabetes and proteinuria > 1 g/day were excluded', 'Mean age was 68±9 years, 65% were men, and 58% were white', '7,520 Systolic Blood Pressure Intervention Trial (SPRINT) participants aged ≥ 50 year with 1 or more CVD risk factors', 'Longitudinal analysis of clinical trial participants']",['angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs'],"['glomerular filtration rate (eGFR', 'mean eGFR', 'SPRINT primary CVD composite outcome (myocardial infarction, acute coronary syndrome, stroke, heart failure, or CVD death) and all-cause mortality', 'eGFR variability', 'Greater eGFR variability', 'Estimated GFR Variability and Risk of Cardiovascular Events and Mortality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}]","[{'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C4524116', 'cui_str': 'Estimated GFR'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.143388,The mean eGFR was 73±21,"[{'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle, WA.'}, {'ForeName': 'Vasantha', 'Initials': 'V', 'LastName': 'Jotwani', 'Affiliation': 'Kidney Health Research Collaborative, San Francisco Veterans Affairs Medical Center and University of California, San Francisco, CA.'}, {'ForeName': 'Adhish', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of Utah Health, Salt Lake City, UT.'}, {'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Cohen', 'Affiliation': 'Renal-Electrolyte and Hypertension Division, Department of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Medical Service, Veteran Affairs Medical Center and Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Areef', 'Initials': 'A', 'LastName': 'Ishani', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Minnesota and Veteran Affairs Medical Center, Minneapolis, MN.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Killeen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'Division of Cardiovascular Medicine, Wake Forest School of Medicine, Winston Salem, NC.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Vascular Biology and Hypertension Program, Division of Cardiovascular Disease, Department of Medicine, School of Medicine, The University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Papademetriou', 'Affiliation': 'Division of Cardiology, Department of Medicine, Georgetown University and Veteran Affairs Medical Center, Washington, DC.'}, {'ForeName': 'Chirag R', 'Initials': 'CR', 'LastName': 'Parikh', 'Affiliation': 'Division of Nephrology, Department of Medicine, John Hopkins University, Baltimore, MD.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of Utah Health, Salt Lake City, UT.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Division of Nephrology, Department of Medicine, Wake Forest School of Medicine, Winston Salem, NC.'}, {'ForeName': 'Leonardo J', 'Initials': 'LJ', 'LastName': 'Tamariz', 'Affiliation': 'Department of Medicine, Miller School of Medicine at the University of Miami, Miami, FL.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Jackson T', 'Initials': 'JT', 'LastName': 'Wright', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospital Cleveland Medical Center, Cleveland, OH.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Kidney Health Research Collaborative, San Francisco Veterans Affairs Medical Center and University of California, San Francisco, CA; Division of General Internal Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, CA.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Division of Preventive Medicine, Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA; Nephrology Section, Veterans Affairs San Diego Healthcare System, La Jolla, CA. Electronic address: joeix@ucsd.edu.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.10.016']
280,33307907,Effects of remote ischemic preconditioning on platelet activation and reactivity in patients undergoing cardiac surgery using cardiopulmonary bypass: a randomized controlled trial.,"During cardiopulmonary bypass (CPB), platelet activation and dysfunction are associated with adverse outcomes. Remote ischemic preconditioning (RIPC) has been shown to attenuate platelet activation. We evaluated the effects of RIPC on platelet activation during CPB in patients undergoing cardiac surgery. Among 58 randomized patients, 26 in the RIPC group and 28 in the sham-RIPC group were analyzed. RIPC consisted of 4 cycles of 5-min ischemia induced by inflation of pneumatic cuff pressure to 200 mmHg, followed by 5-min reperfusion comprising deflation of the cuff on the upper arm. Platelet activation was assessed using flow cytometry analysis of platelet activation markers. The primary endpoint was the AUC of CD62P expression during the first 3 h after initiation of CPB. Secondary outcomes were the AUC of PAC-1 expression and monocyte-platelet aggregates (MPA) during 3 h of CPB. The AUCs of CD62P expression during 3 h after initiation of CPB were 219.4 ± 43.9 and 211.0 ± 41.2 MFI in the RIPC and sham-RIPC groups, respectively (mean difference, 8.42; 95% CI, -14.8 and 31.7 MFI;  p  =.471). The AUCs of PAC-1 expression and MPA did not differ between groups. RIPC did not alter platelet activation and reactivity during CPB in patients undergoing cardiac surgery.",2022,The AUCs of PAC-1 expression and MPA did not differ between groups.,"['patients undergoing cardiac surgery', 'patients undergoing cardiac surgery using cardiopulmonary bypass', '58 randomized patients, 26 in the RIPC group and 28 in the sham-RIPC group were analyzed']","['remote ischemic preconditioning', 'Remote ischemic preconditioning (RIPC', 'RIPC']","['AUC of CD62P expression', 'Platelet activation', 'AUC of PAC-1 expression and monocyte-platelet aggregates (MPA', 'platelet activation and reactivity', 'platelet activation', 'AUCs of CD62P expression', 'AUCs of PAC-1 expression and MPA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",58.0,0.109974,The AUCs of PAC-1 expression and MPA did not differ between groups.,"[{'ForeName': 'Youn Joung', 'Initials': 'YJ', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Karam', 'Initials': 'K', 'LastName': 'Nam', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sol Ji', 'Initials': 'SJ', 'LastName': 'Yoo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seohee', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Bae', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'FACS Core Facility, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hang-Rae', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Department of Biomedical Sciences, BK21 FOUR Biomedical Science Project, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Tae Kyong', 'Initials': 'TK', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yunseok', 'Initials': 'Y', 'LastName': 'Jeon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}]",Platelets,['10.1080/09537104.2020.1856362']
281,33307900,Effect of the School-Based Asthma Care for Teens (SB-ACT) program on asthma morbidity: a 3-arm randomized controlled trial.,"Urban adolescents with asthma often have inadequate preventive care. We tested the effectiveness of the School-Based Asthma Care for Teens (SB-ACT) program on asthma morbidity and preventive medication adherence. Methods:   Subjects/Setting - 12-16yr olds with persistent asthma in Rochester, NY schools.  Design - 3-group randomized trial (2014-2019).  SB-ACT Intervention - Two core components: 1) Directly observed therapy (DOT) of preventive asthma medications, provided in school for at least 6-8 weeks for the teen to learn proper technique and experience the benefits of daily preventive therapy; 2) 4-6 weeks later, 3 sessions of motivational interviewing (MI) to discuss potential benefits from DOT and enhance motivation to take medication independently. We included 2 comparison groups: 1) DOT-only for 6-8wks, and 2) asthma education (AE) attention control. Masked follow-up assessments were conducted at 3, 5, and 7mos.  Outcomes - Mean number of symptom-free days (SFDs)/2 weeks and medication adherence.  Analyses - Modified intention-to-treat repeated measures analysis. Results:  We enrolled 430 teens (56% Black, 32% Hispanic, 85% Medicaid). There were no group differences at baseline. We found no difference in SFDs at any follow-up timepoint. More teens in the SB-ACT and DOT-only groups reported having a preventive asthma medication at each follow-up ( p <.001), and almost daily adherence at 3 and 5-months ( p <.001,  p =.003) compared to AE. By 7 months there were no significant differences between groups in adherence ( p =.49). Conclusion:  SB-ACT improved preventive medication availability and short-term adherence but did not impact asthma symptoms. Further work is needed to create developmentally appropriate and effective interventions for this group.",2022,"More teens in the SB-ACT and DOT-only reported having a preventive asthma medication at each follow-up (p<.001), and almost daily adherence at 3 and 5-months (p<.001, p=.003) compared to AE.","['Subjects/Setting  - 12-16yr olds with persistent asthma in Rochester, NY schools', 'enrolled 430 teens (56% Black, 32% Hispanic, 85% Medicaid', 'Urban adolescents with asthma often have inadequate preventive care', 'Teens (SB-ACT']","['School-Based Asthma Care for Teens (SB-ACT) program', 'SB-ACT Intervention', 'motivational interviewing (MI', 'DOT-only for 6-8wks, and 2) asthma education (AE) attention control', 'SB-ACT', 'School-Based Asthma Care']","['SFDs', 'Asthma Morbidity', 'preventive medication availability and short-term adherence']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1850938', 'cui_str': ""Sorsby's fundus dystrophy""}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",430.0,0.0388884,"More teens in the SB-ACT and DOT-only reported having a preventive asthma medication at each follow-up (p<.001), and almost daily adherence at 3 and 5-months (p<.001, p=.003) compared to AE.","[{'ForeName': 'Jill S', 'Initials': 'JS', 'LastName': 'Halterman', 'Affiliation': 'Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Riekert', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fagnano', 'Affiliation': 'Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Tremblay', 'Affiliation': 'Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Blaakman', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Tajon', 'Affiliation': 'Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Hongyue', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Borrelli', 'Affiliation': 'Center for Behavioral Science Research, Boston University, Boston, MA, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1856869']
282,33322963,A pilot school-based health center intervention to improve asthma chronic care in high-poverty schools.,"OBJECTIVE


To test the feasibility and effectiveness of a multifaceted intervention administered through school-based health centers (SBHCs) to improve asthma control for children in high-poverty schools with not well controlled asthma.
METHODS


Students 4-14 years old with persistent asthma were enrolled from three SBHCs. The centers' advanced practice providers received training on evidence-based asthma guidelines. Students randomized to the intervention received directly observed therapy of their asthma controller medication, medication adjustments as needed by the centers' providers, and daily self-management support. Students randomized to usual care were referred back to their primary care provider (PCP) for routine asthma care.
RESULTS


We enrolled 29 students. Students in the intervention group received their controller medication 92% of days they were in school. Ninety-four percent of follow-up assessments were completed. During the study, 11 of 12 intervention students had a step-up in medication; 2 of 15 usual care students were stepped up by their PCP. Asthma Control Test scores did not differ between groups, although there were significant improvements from baseline to the 7 month follow-up within each group (both  p  < .01). Both FEV 1 % predicted and FEV 1 /FVC ratio significantly worsened in the usual care group (both  p  = .001), but did not change in the intervention group ( p  = .76 and .28 respectively).
CONCLUSIONS


Our pilot data suggest that a multifaceted intervention can be feasibly administered through SBHCs in communities with health disparities. Despite the small sample size, spirometry detected advantages in the intervention group. Further study is needed to optimize the intervention and evaluate outcomes.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT03032744.",2022,"Both FEV 1 % predicted and FEV 1 /FVC ratio significantly worsened in the usual care group (both p = 0.001), but did not change in the intervention group (p = 0.76 and p = 0.28 respectively).
","['High-Poverty Schools', 'children in high poverty schools with not well controlled asthma', 'We enrolled 29 students', '11 of 12 intervention students had a step-up in medication; 2 of 15 usual care students', 'Students 4-14 years old with persistent asthma were enrolled from 3 SBHCs']","['multifaceted intervention administered through school-based health centers (SBHCs', 'usual care were referred back to their primary care provider (PCP', ""intervention received directly observed therapy of their asthma controller medication, medication adjustments as needed by the centers' providers, and daily self-management support"", 'Health Center Intervention']","['FEV 1 /FVC ratio', 'Asthma Control Test scores']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",29.0,0.0342689,"Both FEV 1 % predicted and FEV 1 /FVC ratio significantly worsened in the usual care group (both p = 0.001), but did not change in the intervention group (p = 0.76 and p = 0.28 respectively).
","[{'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Holmes', 'Affiliation': 'Department of Pediatrics, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Orom', 'Affiliation': 'Department of Community Health and Health Behavior, University at Buffalo School of Public Health and Health Professions, Buffalo, NY, USA.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Lehman', 'Affiliation': 'Department of Pediatrics, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Stacie', 'Initials': 'S', 'LastName': 'Lampkin', 'Affiliation': ""Department of Pharmacy Practice, D'Youville College, Buffalo, NY, USA.""}, {'ForeName': 'Jill S', 'Initials': 'JS', 'LastName': 'Halterman', 'Affiliation': 'Department of Pediatrics, University of Rochester School of Medicine, Rochester, NY, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Akiki', 'Affiliation': 'Department of Pediatrics, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Alicia A', 'Initials': 'AA', 'LastName': 'Supernault-Sarker', 'Affiliation': 'Department of Pediatrics, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Butler', 'Affiliation': 'Catholic Health Systems, Buffalo, NY, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Piechowski', 'Affiliation': ""John R. Oishei Children's Hospital, Kaleida Health, Buffalo, NY, USA.""}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Sorrentino', 'Affiliation': ""John R. Oishei Children's Hospital, Kaleida Health, Buffalo, NY, USA.""}, {'ForeName': 'Ziqiang', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, University at Buffalo School of Public Health and Health Professions, Buffalo, NY, USA.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Wilding', 'Affiliation': 'Department of Biostatistics, University at Buffalo School of Public Health and Health Professions, Buffalo, NY, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1864823']
283,33332190,Gefitinib Versus Vinorelbine Plus Cisplatin as Adjuvant Treatment for Stage II-IIIA (N1-N2) EGFR-Mutant NSCLC: Final Overall Survival Analysis of CTONG1104 Phase III Trial.,"PURPOSE


ADJUVANT-CTONG1104 (ClinicalTrials.gov identifier: NCT01405079), a randomized phase III trial, showed that adjuvant gefitinib treatment significantly improved disease-free survival (DFS) versus vinorelbine plus cisplatin (VP) in patients with epidermal growth factor receptor ( EGFR ) mutation-positive resected stage II-IIIA (N1-N2) non-small-cell lung cancer (NSCLC). Here, we report the final overall survival (OS) results.
METHODS


From September 2011 to April 2014, 222 patients from 27 sites were randomly assigned 1:1 to adjuvant gefitinib (n = 111) or VP (n = 111). Patients with resected stage II-IIIA (N1-N2) NSCLC and  EGFR -activating mutation were enrolled, receiving gefitinib for 24 months or VP every 3 weeks for four cycles. The primary end point was DFS (intention-to-treat [ITT] population). Secondary end points included OS, 3-, 5-year (y) DFS rates, and 5-year OS rate. Post hoc analysis was conducted for subsequent therapy data.
RESULTS


Median follow-up was 80.0 months. Median OS (ITT) was 75.5 and 62.8 months with gefitinib and VP, respectively (hazard ratio [HR], 0.92; 95% CI, 0.62 to 1.36;  P  = .674); respective 5-year OS rates were 53.2% and 51.2% ( P  = .784). Subsequent therapy was administered upon progression in 68.4% and 73.6% of patients receiving gefitinib and VP, respectively. Subsequent targeted therapy contributed most to OS (HR, 0.23; 95% CI, 0.14 to 0.38) compared with no subsequent therapy. Updated 3y DFS rates were 39.6% and 32. 5% with gefitinib and VP ( P  = .316) and 5y DFS rates were 22. 6% and 23.2% ( P  = .928), respectively.
CONCLUSION


Adjuvant therapy with gefitinib in patients with early-stage NSCLC and  EGFR  mutation demonstrated improved DFS over standard of care chemotherapy. Although this DFS advantage did not translate to a significant OS difference, OS with adjuvant gefitinib was one of the longest observed in this patient group compared with historic data.",2021,"Subsequent targeted therapy contributed most to OS (HR, 0.23; 95% CI, 0.14 to 0.38) compared with no subsequent therapy.","['Patients with resected stage', 'Stage II-IIIA', 'patients with epidermal growth factor receptor ( EGFR ) mutation-positive resected stage II-IIIA (N1-N2) non-small-cell lung cancer (NSCLC', 'patients with early-stage NSCLC and  EGFR  mutation', 'From September 2011 to April 2014, 222 patients from 27 sites']","['Gefitinib Versus Vinorelbine Plus Cisplatin', 'N1-N2) EGFR-Mutant NSCLC', 'vinorelbine plus cisplatin (VP', 'gefitinib', 'adjuvant gefitinib']","['DFS (intention-to-treat [ITT] population', '5-year OS rates', 'final overall survival (OS) results', 'DFS rates', 'disease-free survival (DFS', 'Median OS (ITT', 'OS, 3-, 5-year (y) DFS rates, and 5-year OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.199911,"Subsequent targeted therapy contributed most to OS (HR, 0.23; 95% CI, 0.14 to 0.38) compared with no subsequent therapy.","[{'ForeName': 'Wen-Zhao', 'Initials': 'WZ', 'LastName': 'Zhong', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Fudan University Affiliated Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Wei-Min', 'Initials': 'WM', 'LastName': 'Mao', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Song-Tao', 'Initials': 'ST', 'LastName': 'Xu', 'Affiliation': 'Fudan University Affiliated Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Yu-Cheng', 'Initials': 'YC', 'LastName': 'Wei', 'Affiliation': 'The Affiliated Hospital of Medical College Qingdao University, Qingdao, China.'}, {'ForeName': 'Yong-Yu', 'Initials': 'YY', 'LastName': 'Liu', 'Affiliation': 'Shenyang Chest Hospital, Shenyang, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Provincial Tumor Hospital, Changchun, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Yin', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ""The People's Hospital of Peking University, Beijing, China.""}, {'ForeName': 'Sheng-Xiang', 'Initials': 'SX', 'LastName': 'Ren', 'Affiliation': 'Shanghai Pulmonary Hospital, Shanghai, China.'}, {'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': ""Tangdu Hospital, Xi'an, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Fujian Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Zhi-Dong', 'Initials': 'ZD', 'LastName': 'Liu', 'Affiliation': 'Beijing Chest Hospital, Beijing, China.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Ke-Neng', 'Initials': 'KN', 'LastName': 'Chen', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Shi-Dong', 'Initials': 'SD', 'LastName': 'Xu', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Lun-Xu', 'Initials': 'LX', 'LastName': 'Liu', 'Affiliation': 'West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Sichuan Cancer Hospital, Chengdu, China.'}, {'ForeName': 'Bu-Hai', 'Initials': 'BH', 'LastName': 'Wang', 'Affiliation': ""The Northern Jiangsu People's Hospital, Yangzhou, China.""}, {'ForeName': 'Hai-Tao', 'Initials': 'HT', 'LastName': 'Ma', 'Affiliation': 'The First Affiliated Hospital of Suzhou University, Suzhou, China.'}, {'ForeName': 'Jin-Ji', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Hong-Hong', 'Initials': 'HH', 'LastName': 'Yan', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Xue-Ning', 'Initials': 'XN', 'LastName': 'Yang', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Si-Yang', 'Initials': 'SY', 'LastName': 'Liu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01820']
284,33314326,"A first-in-human study to evaluate the safety, tolerability and pharmacokinetics of RP3128, an oral calcium release-activated calcium (CRAC) channel modulator in healthy volunteers.","WHAT IS KNOWN AND OBJECTIVE


RP3128, a novel, orally available modulator of calcium released activated calcium (CRAC) channel, is being developed for the potential treatment of autoimmune and inflammatory diseases. RP3128 showed nano-molar potency and activity in a range of in vitro and in vivo models of inflammation. We report a first-in-human study investigating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RP3128 in healthy subjects.
METHODS


A randomized, double-blind, placebo-controlled trial of single (25, 50, 100, 200 and 400 mg) and multiple (7 days: 25, 100 and 400 mg once daily) doses of RP3128 were performed. Thirty-two and 24 subjects were randomized in the single ascending dose (SAD) and multiple ascending dose (MAD) parts, respectively.
RESULTS AND DISCUSSION


RP3128 was well tolerated, with no dose-limiting toxicity at single and multiple doses. Incidence of treatment emergent adverse events (TEAEs) did not increase with ascending RP3128 doses. No changes were seen in cognitive function and ECG parameters. RP3128 was rapidly absorbed. Elimination was slow with a half-life of more than 80 h. Exposures increased with increasing doses. Accumulation was seen on repeated dosing. PD response, as evidenced by lower plasma levels of tumour necrosis factor-alfa (TNFα) and interleukin-4 (IL-4), was seen when compared to pre-dose values or placebo.
WHAT IS NEW AND CONCLUSION


The safety, tolerability and PK/PD profile of RP3128 demonstrates its potential to be developed in inflammatory disorders and support further clinical development (ClinicalTrials.gov number: NCT02958982).",2021,"PD response, as evidenced by lower plasma levels of tumour necrosis factor-alfa (TNFα) and interleukin-4 (IL-4), was seen when compared to pre-dose values or placebo.
","['healthy volunteers', 'Thirty-two and 24 subjects', 'healthy subjects']","['RP3128, an oral calcium release-activated calcium (CRAC) channel modulator', 'placebo']","['safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD', 'safety, tolerability and pharmacokinetics', 'PD response', 'nano-molar potency and activity', 'plasma levels of tumour necrosis factor-alfa (TNFα) and interleukin-4 (IL-4', 'cognitive function and ECG parameters', 'Accumulation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.192179,"PD response, as evidenced by lower plasma levels of tumour necrosis factor-alfa (TNFα) and interleukin-4 (IL-4), was seen when compared to pre-dose values or placebo.
","[{'ForeName': 'Prajak J', 'Initials': 'PJ', 'LastName': 'Barde', 'Affiliation': 'Rhizen Pharmaceuticals SA, La Chaux-de-Fonds, Switzerland.'}, {'ForeName': 'Srikant', 'Initials': 'S', 'LastName': 'Viswanadha', 'Affiliation': 'Rhizen Pharmaceuticals SA, La Chaux-de-Fonds, Switzerland.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Veeraraghavan', 'Affiliation': 'Rhizen Pharmaceuticals SA, La Chaux-de-Fonds, Switzerland.'}, {'ForeName': 'Swaroop V', 'Initials': 'SV', 'LastName': 'Vakkalanka', 'Affiliation': 'Rhizen Pharmaceuticals SA, La Chaux-de-Fonds, Switzerland.'}, {'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Rhizen Pharmaceuticals SA, La Chaux-de-Fonds, Switzerland.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13322']
285,33306283,Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19.,"BACKGROUND


Severe coronavirus disease 2019 (Covid-19) is associated with dysregulated inflammation. The effects of combination treatment with baricitinib, a Janus kinase inhibitor, plus remdesivir are not known.
METHODS


We conducted a double-blind, randomized, placebo-controlled trial evaluating baricitinib plus remdesivir in hospitalized adults with Covid-19. All the patients received remdesivir (≤10 days) and either baricitinib (≤14 days) or placebo (control). The primary outcome was the time to recovery. The key secondary outcome was clinical status at day 15.
RESULTS


A total of 1033 patients underwent randomization (with 515 assigned to combination treatment and 518 to control). Patients receiving baricitinib had a median time to recovery of 7 days (95% confidence interval [CI], 6 to 8), as compared with 8 days (95% CI, 7 to 9) with control (rate ratio for recovery, 1.16; 95% CI, 1.01 to 1.32; P = 0.03), and a 30% higher odds of improvement in clinical status at day 15 (odds ratio, 1.3; 95% CI, 1.0 to 1.6). Patients receiving high-flow oxygen or noninvasive ventilation at enrollment had a time to recovery of 10 days with combination treatment and 18 days with control (rate ratio for recovery, 1.51; 95% CI, 1.10 to 2.08). The 28-day mortality was 5.1% in the combination group and 7.8% in the control group (hazard ratio for death, 0.65; 95% CI, 0.39 to 1.09). Serious adverse events were less frequent in the combination group than in the control group (16.0% vs. 21.0%; difference, -5.0 percentage points; 95% CI, -9.8 to -0.3; P = 0.03), as were new infections (5.9% vs. 11.2%; difference, -5.3 percentage points; 95% CI, -8.7 to -1.9; P = 0.003).
CONCLUSIONS


Baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with Covid-19, notably among those receiving high-flow oxygen or noninvasive ventilation. The combination was associated with fewer serious adverse events. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT04401579.).",2021,"The 28-day mortality was 5.1% in the combination group and 7.8% in the control group (hazard ratio for death, 0.65; 95% CI, 0.39 to 1.09).","['Hospitalized Adults with Covid-19', '1033 patients underwent randomization (with 515 assigned to combination treatment and 518 to control', 'hospitalized adults with Covid-19']","['Baricitinib plus Remdesivir', 'baricitinib (≤14 days) or placebo (control', 'placebo']","['serious adverse events', 'clinical status', 'new infections', '28-day mortality', 'time to recovery', 'recovery time', 'Serious adverse events', 'median time to recovery']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0439633', 'cui_str': 'New infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",1033.0,0.619885,"The 28-day mortality was 5.1% in the combination group and 7.8% in the control group (hazard ratio for death, 0.65; 95% CI, 0.39 to 1.09).","[{'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Kalil', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Patterson', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Tomashek', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Cameron R', 'Initials': 'CR', 'LastName': 'Wolfe', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Varduhi', 'Initials': 'V', 'LastName': 'Ghazaryan', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Guillermo M', 'Initials': 'GM', 'LastName': 'Ruiz-Palacios', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Lanny', 'Initials': 'L', 'LastName': 'Hsieh', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kline', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tapson', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Iovine', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Mamta K', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Sweeney', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Hana M', 'Initials': 'HM', 'LastName': 'El Sahly', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'Branche', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Justino', 'Initials': 'J', 'LastName': 'Regalado Pineda', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Uriel', 'Initials': 'U', 'LastName': 'Sandkovsky', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Anne F', 'Initials': 'AF', 'LastName': 'Luetkemeyer', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Cohen', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Finberg', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Patrick E H', 'Initials': 'PEH', 'LastName': 'Jackson', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Babafemi', 'Initials': 'B', 'LastName': 'Taiwo', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Catharine I', 'Initials': 'CI', 'LastName': 'Paules', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Arguinchona', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Erdmann', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Neera', 'Initials': 'N', 'LastName': 'Ahuja', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Frank', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Myoung-Don', 'Initials': 'MD', 'LastName': 'Oh', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Eu-Suk', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Seow Y', 'Initials': 'SY', 'LastName': 'Tan', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Mularski', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Nielsen', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Philip O', 'Initials': 'PO', 'LastName': 'Ponce', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Barbara S', 'Initials': 'BS', 'LastName': 'Taylor', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'LuAnn', 'Initials': 'L', 'LastName': 'Larson', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Nadine G', 'Initials': 'NG', 'LastName': 'Rouphael', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Saklawi', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Valeria D', 'Initials': 'VD', 'LastName': 'Cantos', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Ko', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Engemann', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Alpesh N', 'Initials': 'AN', 'LastName': 'Amin', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Billings', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Marie-Carmelle', 'Initials': 'MC', 'LastName': 'Elie', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Davey', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Burgess', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ferreira', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Makowski', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Anabela', 'Initials': 'A', 'LastName': 'Cardoso', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'de Bono', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Bonnett', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Proschan', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Deye', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Walla', 'Initials': 'W', 'LastName': 'Dempsey', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Seema U', 'Initials': 'SU', 'LastName': 'Nayak', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Dodd', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'From the University of Nebraska Medical Center, Omaha (A.C.K., L.L.); University of Texas Health San Antonio, University Health, and the South Texas Veterans Health Care System, San Antonio (T.F.P., P.O.P., B.S.T.), UT Southwestern Medical Center, Parkland Health and Hospital System (M.K.J.) and Baylor Scott and White Health (U.S.), Dallas, and Baylor College of Medicine, Houston (H.M.E.S.) - all in Texas; Emory University (A.K.M., N.G.R., Y.S., V.C.M., V.D.C.) and Grady Memorial Hospital (V.D.C.), Atlanta, and Atlanta Veterans Affairs Medical Center, Decatur (V.C.M.) - both in Georgia; the National Institute of Allergy and Infectious Diseases, National Institutes of Health (K.M.T., V.G., R.T.D., M.P., G.A.D., W.D., S.U.N., L.E.D., J.H.B.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, and Emmes (J.F., M.G., M.M.) and Clinical Monitoring Research Program Directorate, Frederick National Laboratory (T.B.), Rockville - both in Maryland; Duke University, Durham, NC (C.R.W., E.R.K., J.J.E.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, (G.M.R.-P.) and Instituto Nacional de Enfermedades Respiratorias (J.R.P.), Mexico City; University of California Irvine, Irvine (L.H., A.N.A., M.W.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, San Diego, La Jolla (D.A.S.), University of California, San Francisco, San Francisco (A.F.L.), University of California, Davis, Davis (S.H.C.), and Stanford University, Stanford (N.A.) - all in California; University of Minnesota Medical School, Minneapolis (S.K., J.B.); University of Florida, Gainesville (N.M.I., M.-C.E.); University of Rochester, Rochester, NY (A.R.B.); National Center for Infectious Diseases, Tan Tock Seng Hospital, Lee Kong Chian School of Medicine, and Yong Loo Lin School of Medicine (D.C.L.), and Changi General Hospital (S.Y.T.), Singapore; University of Massachusetts Medical School, Worcester (R.W.F.); University of Virginia, Charlottesville (P.E.H.J.); Northwestern University, Chicago (B.T.); Penn State Health Milton S. Hershey Medical Center, Hershey, PA (C.I.P.); Providence Sacred Heart Medical Center, Spokane, WA (H.A.); University of Alabama at Birmingham, Birmingham (N.E.); Denver Health and Hospital Authority, Denver (M.F.); Seoul National University Hospital, Seoul (M.O.), and Seoul National University Bundang Hospital, Seongnam (E.-S.K.) - both in South Korea; Kaiser Permanente Northwest, Portland, OR (R.A.M.); Aalborg University Hospital, Aalborg, Denmark (H.N.); and Eli Lilly, Indianapolis (A.C., S.B.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2031994']
286,33349288,Genotype-environment correlation by intervention effects underlying middle childhood peer rejection and associations with adolescent marijuana use.,"Aggressive behavior in middle childhood can contribute to peer rejection, subsequently increasing risk for substance use in adolescence. However, the quality of peer relationships a child experiences can be associated with his or her genetic predisposition, a genotype-environment correlation (rGE). In addition, recent evidence indicates that psychosocial preventive interventions can buffer genetic predispositions for negative behavior. The current study examined associations between polygenic risk for aggression, aggressive behavior, and peer rejection from 8.5 to 10.5 years, and the subsequent influence of peer rejection on marijuana use in adolescence (n = 515; 256 control, 259 intervention). Associations were examined separately in control and intervention groups for children of families who participated in a randomized controlled trial of the family-based preventive intervention, the Family Check-Up . Using time-varying effect modeling (TVEM), polygenic risk for aggression was associated with peer rejection from approximately age 8.50 to 9.50 in the control group but no associations were present in the intervention group. Subsequent analyses showed peer rejection mediated the association between polygenic risk for aggression and adolescent marijuana use in the control group. The role of rGEs in middle childhood peer processes and implications for preventive intervention programs for adolescent substance use are discussed.",2022,"Associations were examined separately in control and intervention groups for children of families who participated in a randomized controlled trial of the family-based preventive intervention, the Family Check-Up .","['marijuana use in adolescence (n = 515; 256 control, 259 intervention']","['family-based preventive intervention, the Family Check-Up ']","['peer rejection', 'time-varying effect modeling (TVEM), polygenic risk for aggression']","[{'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0420160', 'cui_str': 'History and physical examination, school'}]","[{'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]",515.0,0.0118059,"Associations were examined separately in control and intervention groups for children of families who participated in a randomized controlled trial of the family-based preventive intervention, the Family Check-Up .","[{'ForeName': 'Kit K', 'Initials': 'KK', 'LastName': 'Elam', 'Affiliation': 'Department of Applied Health Science, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Sierra', 'Initials': 'S', 'LastName': 'Clifford', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, Arizona, USA.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Ruof', 'Affiliation': 'T. Denny Sanford School of Social and Family Dynamics, Arizona State University, Tempe, Arizona, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Melvin N', 'Initials': 'MN', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lemery-Chalfant', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, Arizona, USA.'}]",Development and psychopathology,['10.1017/S0954579420001066']
287,33353412,"A randomized controlled trial of a web-based personalized feedback intervention targeting frequent indoor tanning bed users: Engagement, acceptability, and preliminary behavioral outcomes.","Frequent indoor tanning bed use is an established public health concern, yet research on tanning cessation interventions for frequent tanners is lacking. We describe the protocol for a brief, web-based tanning behavior change intervention and present evidence that it is acceptable and engaging to frequent indoor tanners. Lower tanning rates were not observed among participants receiving the intervention in a randomized controlled trial but participants' interest in changing tanning increased. This intervention could be a useful approach to increasing frequent tanners' interest in behavior change and openness to engaging within a more intensive, multi-component tanning cessation program. Trial Registration:  NCT03448224 Clinical Trials.gov (https://clinicaltrials.gov/ct2/show/NCT03448224?cond=NCT03448224&draw=2&rank=1).",2022,Lower tanning rates were not observed among participants receiving the intervention in a randomized controlled trial but participants' interest in changing tanning increased.,[],['web-based personalized feedback intervention'],[],[],"[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.105227,Lower tanning rates were not observed among participants receiving the intervention in a randomized controlled trial but participants' interest in changing tanning increased.,"[{'ForeName': 'Jerod L', 'Initials': 'JL', 'LastName': 'Stapleton', 'Affiliation': 'University of Kentucky College of Public Health, USA.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Ray', 'Affiliation': 'University of Kentucky College of Public Health, USA.'}, {'ForeName': 'Shannon D', 'Initials': 'SD', 'LastName': 'Glenn', 'Affiliation': 'Rutgers, The State University of New Jersey, USA.'}, {'ForeName': 'Laurie E', 'Initials': 'LE', 'LastName': 'McLouth', 'Affiliation': 'University of Kentucky College of Public Health, USA.'}, {'ForeName': 'Veenat', 'Initials': 'V', 'LastName': 'Parmar', 'Affiliation': 'Rutgers, The State University of New Jersey, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Manne', 'Affiliation': 'Rutgers, The State University of New Jersey, USA.'}]",Journal of health psychology,['10.1177/1359105320982038']
288,33349674,Distinct trajectories of response to prefrontal tDCS in major depression: results from a 3-arm randomized controlled trial.,"Transcranial direct current stimulation (tDCS) is a safe, effective treatment for major depressive disorder (MDD). While antidepressant effects are heterogeneous, no studies have investigated trajectories of tDCS response. We characterized distinct improvement trajectories and associated baseline characteristics for patients treated with prefrontal tDCS, an active pharmacotherapy (escitalopram), and placebo. This is a secondary analysis of a randomized, non-inferiority, double-blinded trial (ELECT-TDCS, N = 245). Participants were diagnosed with an acute unipolar, nonpsychotic, depressive episode, and presented Hamilton Depression Rating Scale (17-items, HAM-D) scores ≥17. Latent trajectory modeling was used to identify HAM-D response trajectories over a 10-week treatment. Top-down (hypothesis-driven) and bottom-up (data-driven) methods were employed to explore potential predictive features using, respectively, conservatively corrected regression models and a cross-validated stability ranking procedure combined with elastic net regularization. Three trajectory classes that were distinct in response speed and intensity (rapid, slow, and no/minimal improvement) were identified for escitalopram, tDCS, and placebo. Differences in response and remission rates were significant early for all groups. Depression severity, use of benzodiazepines, and age were associated with no/minimal improvement. No significant differences in trajectory assignment were found in tDCS vs. placebo comparisons (38.3, 34, and 27.6%; vs. 23.3, 43.3, and 33.3% for rapid, slow, and no/minimal trajectories, respectively). Additional features are suggested in bottom-up analyses. Summarily, groups treated with tDCS, escitalopram, and placebo differed in trajectory class distributions and baseline predictors of response. Our results might be relevant for designing further studies.",2021,"No significant differences in trajectory assignment were found in tDCS vs. placebo comparisons (38.3, 34, and 27.6%; vs. 23.3, 43.3, and 33.3% for rapid, slow, and no/minimal trajectories, respectively).","['patients treated with prefrontal tDCS, an active pharmacotherapy (escitalopram), and', 'Participants were diagnosed with an acute unipolar, nonpsychotic, depressive episode, and presented Hamilton Depression Rating Scale (17-items, HAM-D) scores ≥17', 'major depressive disorder (MDD', 'major depression']","['prefrontal tDCS', 'Transcranial direct current stimulation (tDCS', 'placebo', 'tDCS, escitalopram, and placebo']","['trajectory assignment', 'response and remission rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.251709,"No significant differences in trajectory assignment were found in tDCS vs. placebo comparisons (38.3, 34, and 27.6%; vs. 23.3, 43.3, and 33.3% for rapid, slow, and no/minimal trajectories, respectively).","[{'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Goerigk', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Nußbaumstraße 7, 80336, Munich, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Nußbaumstraße 7, 80336, Munich, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bühner', 'Affiliation': 'Department of Psychological Methodology and Assessment, Ludwig-Maximilians-University, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Sarubin', 'Affiliation': 'Hochschule Fresenius, University of Applied Sciences, Infanteriestraße 11A, 80797, Munich, Germany.'}, {'ForeName': 'Tyler S', 'Initials': 'TS', 'LastName': 'Kaster', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, 1001 Queen Street West, Toronto, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, 1001 Queen Street West, Toronto, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, 1001 Queen Street West, Toronto, Canada.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Borrione', 'Affiliation': 'Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, R Dr Ovidio Pires de Campos 785, 2o andar, 05403-000, São Paulo, Brazil.'}, {'ForeName': 'Lais B', 'Initials': 'LB', 'LastName': 'Razza', 'Affiliation': 'Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, R Dr Ovidio Pires de Campos 785, 2o andar, 05403-000, São Paulo, Brazil.'}, {'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, R Dr Ovidio Pires de Campos 785, 2o andar, 05403-000, São Paulo, Brazil. brunoni@usp.br.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00935-x']
289,33367621,Effect of Aspirin on Activities of Daily Living Disability in Community-Dwelling Older Adults.,"BACKGROUND


Cerebrovascular events, dementia, and cancer can contribute to physical disability with activities of daily living (ADL). It is unclear whether low-dose aspirin reduces this burden in aging populations. In a secondary analysis, we now examine aspirin's effects on incident and persistent ADL disability within a primary prevention aspirin trial in community-dwelling older adults.
METHODS


The ASPREE (ASPirin in Reducing Events in the Elderly) trial of daily 100 mg aspirin versus placebo recruited 19 114 healthy adults aged 70+ years (65+ years if U.S. minority) in Australia and the United States. Six basic ADLs were assessed every 6 months. Incident ADL disability was defined as inability or severe difficulty with ≥1 ADL; persistence was confirmed if the same ADL disability remained after 6 months. Proportional hazards modeling compared time to incident or persistent ADL disability for aspirin versus placebo; death without prior disability was a competing risk.
RESULTS


Over a median of 4.7 years, incident ADL disability was similar in those receiving aspirin (776/9525) and placebo (787/9589) with walking, bathing, dressing, and transferring the most commonly reported. Only 24% of incident ADL disability progressed to persistent. Persistent ADL disability was lower in the aspirin group (4.3 vs 5.3 events/1000 py; hazard ratio [HR] = 0.81, 95% confidence interval [CI]: 0.66-1.00), with bathing and dressing the most common ADL disabilities in both groups. Following persistent ADL disability, there were more deaths in the aspirin group (24 vs 12).
DISCUSSION


Low-dose aspirin in initially healthy older people did not reduce the risk of incident ADL disability, although there was evidence of reduced persistent ADL disability.",2021,"Persistent ADL disability was lower in the aspirin group (4.3 versus 5.3 events/1000py; HR=0.81, 95% CI:0.66-1.00), with bathing and dressing the most common ADL disabilities in both groups.","['19,114 healthy adults aged 70+ years (65+ years if U.S. minority) in Australia and the U.S. Six basic ADLs', 'initially healthy older people', 'Community-Dwelling Older Adults', 'community-dwelling older adults']","['Aspirin', 'ASPREE (ASPirin', 'placebo', 'aspirin']","['ADL disability', 'Activities of Daily Living Disability', 'Incident ADL disability', 'deaths', 'incident ADL disability', 'Persistent ADL disability']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]",19114.0,0.101629,"Persistent ADL disability was lower in the aspirin group (4.3 versus 5.3 events/1000py; HR=0.81, 95% CI:0.66-1.00), with bathing and dressing the most common ADL disabilities in both groups.","[{'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Espinoza', 'Affiliation': 'Division of Geriatrics, Gerontology and Palliative Medicine, Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Center, San Antonio, USA.'}, {'ForeName': 'Le T P', 'Initials': 'LTP', 'LastName': 'Thao', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, The University of Iowa, Iowa City, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, Illinois, USA.""}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Ward', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elsdon', 'Initials': 'E', 'LastName': 'Storey', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Trevaks', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sharyn M', 'Initials': 'SM', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Nigel P', 'Initials': 'NP', 'LastName': 'Stocks', 'Affiliation': 'Discipline of General Practice, Adelaide Medical School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Clinical Outcomes and Research, Minneapolis Medical Research Foundation, Hennepin Healthcare Research Institute, Minneapolis, USA.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': 'Center for Aging and Population Health, University of Pittsburgh, Pennsylvania, USA.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa316']
290,33417105,Associations of Father and Adult Male Presence with First Pregnancy and HIV Infection: Longitudinal Evidence from Adolescent Girls and Young Women in Rural South Africa (HPTN  068).,"This study, a secondary analysis of the HPTN 068 randomized control trial, aimed to quantify the association of father and male presence with HIV incidence and first pregnancy among 2533 school-going adolescent girls and young women (AGYW) in rural South Africa participating in the trial between March 2011 and April 2017. Participants' ages ranged from 13-20 years at study enrollment and 17-25 at the post-intervention visit. HIV and pregnancy incidence rates were calculated for each level of the exposure variables using Poisson regression, adjusted for age using restricted quadratic spline variables, and, in the case of pregnancy, also adjusted for whether the household received a social grant. Our study found that AGYW whose fathers were deceased and adult males were absent from the household were most at risk for incidence of first pregnancy and HIV (pregnancy: aIRR = 1.30, Wald 95% CI 1.05, 1.61, Wald chi-square p = 0.016; HIV: aIRR = 1.27, Wald 95% CI 0.84, 1.91, Wald chi-square p = 0.263) as compared to AGYW whose biological fathers resided with them. For AGYW whose fathers were deceased, having other adult males present as household members seemed to attenuate the incidence (pregnancy: aIRR = 0.92, Wald 95% CI 0.74, 1.15, Wald chi-square p = 0.462; HIV: aIRR = 0.90, Wald 95% CI 0.58, 1.39, Wald chi-square p = 0.623) such that it was similar, and therefore not statistically significantly different, to AGYW whose fathers were present in the household.",2021,"HIV: aIRR = 1.27, Wald 95% CI 0.84, 1.91, Wald chi-square p = 0.263) as compared to AGYW whose biological fathers resided with them.","['fathers were deceased and adult males', 'father and male presence with HIV incidence and first pregnancy among 2533 school-going adolescent girls and young women (AGYW) in rural South Africa participating in the trial between March 2011 and April 2017', 'Adolescent Girls and Young Women in Rural South Africa (HPTN \xa0068', ""Participants' ages ranged from 13-20\xa0years at study enrollment and 17-25 at the post-intervention visit""]",[],['HIV and pregnancy incidence rates'],"[{'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0860096', 'cui_str': 'Primigravida'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.0663049,"HIV: aIRR = 1.27, Wald 95% CI 0.84, 1.91, Wald chi-square p = 0.263) as compared to AGYW whose biological fathers resided with them.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Albert', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, Chapel Hill, NC, 27599-7435, USA. Lisamariealbert@gmail.com.'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'Edwards', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, Chapel Hill, NC, 27599-7435, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pence', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, Chapel Hill, NC, 27599-7435, USA.'}, {'ForeName': 'Ilene S', 'Initials': 'IS', 'LastName': 'Speizer', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hillis', 'Affiliation': 'National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kahn', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Unit, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'F Xavier', 'Initials': 'FX', 'LastName': 'Gómez-Olivé', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Unit, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Wagner', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Unit, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Twine', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Unit, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Drive, 2101 McGavran-Greenberg Hall, Chapel Hill, NC, 27599-7435, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03147-y']
291,33378082,"Hazardous Alcohol Use, Impulsivity, and HIV-Risk Behavior Among HIV-Positive Russian Patients With a History of Injection Drug Use.","BACKGROUND AND OBJECTIVES


Previous findings on the association between hazardous drinking and HIV-risk behavior have been equivocal, varying by population and individual difference factors. This study examined associations between hazardous drinking, impulsivity, and HIV-risk behaviors among HIV-positive Russian patients with a history of injection drug use (IDU), not on antiretroviral therapy.
METHODS


Negative binomial regression analyses of data from a randomized controlled trial were performed (N = 241). Main independent variables were the Alcohol Use Disorders Identification Test and the Barratt Impulsiveness Scale. Outcomes were number of condomless sexual episodes (CSE; primary), number of sexual partners, and needle-sharing frequency (secondary).
RESULTS


Hazardous drinking was positively associated with the frequency of CSE (adjusted incidence rate ratio [aIRR] = 2.16, 95% confidence interval [CI], 1.98-2.36). Moderate (aIRR = 0.51, 95% CI, 0.46-0.56) and high (aIRR = 0.66, 95% CI, 0.60-0.73) impulsivity were associated with fewer CSE compared with low impulsivity. Hazardous drinking (aIRR = 0.64, 95% CI, 0.52-0.79) and impulsivity (aIRR = 0.95, 95% CI, 0.94-0.96) were both associated with fewer sexual partners. Hazardous drinking and impulsivity were each associated with increased needle sharing. The association between hazardous drinking and number of needle-shares was strongest at higher impulsivity levels.
CONCLUSION AND SCIENTIFIC SIGNIFICANCE


Hazardous drinking may be a risk factor for CSE among HIV-positive Russian patients and may influence needle sharing. Findings contribute to our understanding of the interactive associations between hazardous drinking and impulsivity with sexual risk behaviors and needle sharing among HIV-positive Russian patients with a history of IDU. (Am J Addict 2020;00:00-00).",2021,"RESULTS


Hazardous drinking was positively associated with the frequency of CSE (adjusted incidence rate ratio [aIRR] = 2.16, 95% confidence interval [CI], 1.98-2.36).","['HIV-positive Russian patients with a history of IDU', 'HIV-positive Russian patients with a history of injection drug use (IDU), not on antiretroviral therapy', 'HIV-Positive Russian Patients']",[],"['hazardous drinking, impulsivity, and HIV-risk behaviors', 'Hazardous drinking', 'Alcohol Use Disorders Identification Test and the Barratt Impulsiveness Scale', 'number of condomless sexual episodes (CSE; primary), number of sexual partners, and needle-sharing frequency (secondary', 'frequency of CSE', 'Hazardous drinking and impulsivity', 'impulsivity', 'Hazardous Alcohol Use, Impulsivity, and HIV-Risk Behavior']","[{'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0035967', 'cui_str': 'Russian language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]",[],"[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0556463', 'cui_str': 'Number of sexual partners'}, {'cui': 'C0085091', 'cui_str': 'Shares needles'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.0367086,"RESULTS


Hazardous drinking was positively associated with the frequency of CSE (adjusted incidence rate ratio [aIRR] = 2.16, 95% confidence interval [CI], 1.98-2.36).","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Chavez', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Tibor P', 'Initials': 'TP', 'LastName': 'Palfai', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Cheng', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Blokhina', 'Affiliation': 'First St. Petersburg Pavlov State Medical University, St. Petersburg, Russian Federation.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Gnatienko', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Department of Medicine, Section of General Internal Medicine, Boston University School of Medicine/Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Quinn', 'Affiliation': 'Biostatistics and Epidemiology Data Analytics Center, Boston University School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Krupitsky', 'Affiliation': 'First St. Petersburg Pavlov State Medical University, St. Petersburg, Russian Federation.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Department of Medicine, Section of General Internal Medicine, Boston University School of Medicine/Boston Medical Center, Boston, Massachusetts.'}]",The American journal on addictions,['10.1111/ajad.13112']
292,33372745,Efficacy of Early Prophylaxis Against Catheter-Associated Thrombosis in Critically Ill Children: A Bayesian Phase 2b Randomized Clinical Trial.,"OBJECTIVES


We obtained preliminary evidence on the efficacy of early prophylaxis on the risk of central venous catheter-associated deep venous thrombosis and its effect on thrombin generation in critically ill children.
DESIGN


Bayesian phase 2b randomized clinical trial.
SETTING


Seven PICUs.
PATIENTS


Children less than 18 years old with a newly inserted central venous catheter and at low risk of bleeding.
INTERVENTION


Enoxaparin adjusted to anti-Xa level of 0.2-0.5 international units/mL started at less than 24 hours after insertion of central venous catheter (enoxaparin arm) versus usual care without placebo (usual care arm).
MEASUREMENTS AND MAIN RESULTS


At the interim analysis, the proportion of central venous catheter-associated deep venous thrombosis on ultrasonography in the usual care arm, which was 54.2% of 24 children, was significantly higher than that previously reported. This resulted in misspecification of the preapproved Bayesian analysis, reversal of direction of treatment effect, and early termination of the randomized clinical trial. Nevertheless, with 30.4% of 23 children with central venous catheter-associated deep venous thrombosis on ultrasonography in the enoxaparin arm, risk ratio of central venous catheter-associated deep venous thrombosis was 0.55 (95% credible interval, 0.24-1.11). Including children without ultrasonography, clinically relevant central venous catheter-associated deep venous thrombosis developed in one of 27 children (3.7%) in the enoxaparin arm and seven of 24 (29.2%) in the usual care arm (p = 0.02). Clinically relevant bleeding developed in one child randomized to the enoxaparin arm. Response profile of endogenous thrombin potential, a measure of thrombin generation, was not statistically different between trial arms.
CONCLUSIONS


These findings suggest the efficacy and safety of early prophylaxis that should be validated in a pivotal randomized clinical trial.",2021,"Response profile of endogenous thrombin potential, a measure of thrombin generation, was not statistically different between trial arms.
","['Seven PICUs', 'Children less than 18 years old with a newly inserted central venous catheter and at low risk of bleeding', 'critically ill children', 'Critically Ill Children']","['Enoxaparin', 'central venous catheter (enoxaparin arm) versus usual care without placebo', 'Early Prophylaxis Against Catheter-Associated Thrombosis', 'enoxaparin']","['relevant central venous catheter-associated deep venous thrombosis', 'deep venous thrombosis', 'proportion of central venous catheter-associated deep venous thrombosis', 'efficacy and safety', 'risk ratio of central venous catheter-associated deep venous thrombosis']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]","[{'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",23.0,0.143175,"Response profile of endogenous thrombin potential, a measure of thrombin generation, was not statistically different between trial arms.
","[{'ForeName': 'E Vincent S', 'Initials': 'EVS', 'LastName': 'Faustino', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Shabanova', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Leslie J', 'Initials': 'LJ', 'LastName': 'Raffini', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Kandil', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Pediatrics, New York Medical College, Maria Fareri Children's Hospital, Valhalla, NY.""}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Pinto', 'Affiliation': ""Department of Pediatrics, New York Medical College, Maria Fareri Children's Hospital, Valhalla, NY.""}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Cholette', 'Affiliation': ""Department of Pediatrics, University of Rochester Golisano Children's Hospital, Rochester, NY.""}, {'ForeName': 'Sheila J', 'Initials': 'SJ', 'LastName': 'Hanson', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Marianne E', 'Initials': 'ME', 'LastName': 'Nellis', 'Affiliation': 'Department of Pediatrics, NY Presbyterian Hospital - Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Cicero T', 'Initials': 'CT', 'LastName': 'Silva', 'Affiliation': 'Department of Diagnostic Radiology, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Chima', 'Affiliation': ""Division of Critical Care Medicine, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Sharathkumar', 'Affiliation': 'Stead Family Department of Pediatrics, University of Iowa Carver College of Medicine, Iowa City, IA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Thomas', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'McPartland', 'Affiliation': 'Yale Center for Clinical Investigation, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Joana A', 'Initials': 'JA', 'LastName': 'Tala', 'Affiliation': ""Pediatric Intensive Care Unit, Yale-New Haven Children's Hospital, New Haven, CT.""}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Spinella', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004784']
293,33395671,Sustained attention to response task-related beta oscillations relate to performance and provide a functional biomarker in ALS.,"Objective. To characterize the cortical oscillations associated with performance of the sustained attention to response task (SART) and their disruptions in the neurodegenerative condition amyotrophic lateral sclerosis (ALS). Approach. A randomised SART was undertaken by 24 ALS patients and 33 healthy controls during 128-channel electroencephalography (EEG). Complex Morlet wavelet transform was used to quantify non-phase-locked oscillatory activity in event-related spectral perturbations associated with performing the SART. We investigated the relationships between these perturbations and task performance, and associated motor and cognitive changes in ALS. Main results. SART induced theta-band event-related synchronization (ERS) and alpha- and beta-band event-related desynchronization (ERD), followed by rebound beta ERS, in both Go and NoGo trials across the frontoparietal axis, with NoGo trials eliciting greater theta ERS and lesser beta ERS. Controls with greater Go trial beta ERS performed with greater speed and less accuracy. ALS patients exhibited increased anticipation compared to controls but similar reaction times and accuracy. Prefrontal (area under the receiver operating characteristic curve (AUROC) = 0.8, Cohen's d = 0.97) and parietal (AUROC = 0.82, Cohen's d = 1.12) beta-band ERD was significantly reduced in ALS but did not relate to performance, while patients with higher Edinburgh Cognitive and Behavioural ALS Screen (ECAS) ALS-specific scores demonstrated greater ERS in beta (rho = 0.72) upon successful withholding. Significance. EEG measurement of task-related oscillation changes reveals variation in cortical network engagement in relation to speed versus accuracy strategies. Such measures can also capture cognitive and motor network pathophysiology in the absence of task performance decline, which may facilitate development of more sensitive early neurodegenerative disease biomarkers.",2021,"beta-band ERD was significantly reduced in ALS but did not relate to performance, while patients with higher ECAS ALS-specific scores demonstrated greater ERS in beta (rho=0.72) upon successful withholding.
",['24 ALS patients and 33 healthy controls during 128-channel electroencephalography'],[],"['beta-band ERD', 'ALS', 'SART induced theta-band event-related synchronization (ERS) and alpha- and beta-band event-related desynchronization (ERD']","[{'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",[],"[{'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",,0.0431755,"beta-band ERD was significantly reduced in ALS but did not relate to performance, while patients with higher ECAS ALS-specific scores demonstrated greater ERS in beta (rho=0.72) upon successful withholding.
","[{'ForeName': 'Roisin', 'Initials': 'R', 'LastName': 'McMackin', 'Affiliation': 'Academic Unit of Neurology, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Dukic', 'Affiliation': 'Academic Unit of Neurology, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Emmet', 'Initials': 'E', 'LastName': 'Costello', 'Affiliation': 'Academic Unit of Neurology, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Pinto-Grau', 'Affiliation': 'Academic Unit of Neurology, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Keenan', 'Affiliation': 'Academic Unit of Neurology, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Fasano', 'Affiliation': 'Academic Unit of Neurology, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Buxo', 'Affiliation': 'Academic Unit of Neurology, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Heverin', 'Affiliation': 'Academic Unit of Neurology, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Reilly', 'Affiliation': 'Trinity College Institute of Neuroscience, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Pender', 'Affiliation': 'Academic Unit of Neurology, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Hardiman', 'Affiliation': 'Academic Unit of Neurology, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Nasseroleslami', 'Affiliation': 'Academic Unit of Neurology, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}]",Journal of neural engineering,['10.1088/1741-2552/abd829']
294,33412916,Impact of Diet and Exercise on Weight and Cognition in Older Adults: A Rapid Review.,"OBJECTIVE


To determine where the current literature stands in regard to diet/exercise interventions on cognition in overweight or obese individuals.
DATA SOURCE


A rapid review was conducted of English-language studies published in Medline from January 1965 to January 2020.
STUDY INCLUSION AND EXCLUSION CRITERIA


Included studies were intervention studies lasting ≥12 weeks, with participants aged ≥65 years, with a body mass index ≥25 kg/m 2 .
DATA EXTRACTION


Data extracted included study population, duration, intervention design, outcomes, and results.
DATA SYNTHESIS


Outcomes were qualitatively measured due to paucity of RTC.
RESULTS


1845 citations were identified, 31 full-text articles were reviewed, and 5 studies were included. Studies had usual care control groups and combined exercise/diet intervention groups with 31-3,526 participants randomized to each arm. Mean age of participants was 69.2-83.4 years. Studies reporting on cognitive changes showed marginally significant positive changes in cognition, and those that reported BMI indicated potential improvements in cognition.
CONCLUSIONS


The number of interventions assessing the combined effects of both diet and exercise is low. Future studies should evaluate the impact of combined effects to ascertain whether cognitive decline may be reversed in older adults with a BMI ≥25 kg/m 2 .",2021,"Studies reporting on cognitive changes showed marginally significant positive changes in cognition, and those that reported BMI indicated potential improvements in cognition.
","['overweight or obese individuals', 'Older Adults', 'Mean age of participants was 69.2-83.4 years', 'participants aged ≥65 years, with a body mass index ≥25 kg/m 2 ', '1845 citations were identified, 31 full-text articles were reviewed, and 5 studies were included', 'older adults with a BMI ≥25 kg/m 2 ', 'English-language studies published in Medline from January 1965 to January 2020']","['Diet and Exercise', 'diet/exercise interventions', 'combined exercise/diet intervention']",['Weight and Cognition'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0025141', 'cui_str': 'MEDLINE'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",1845.0,0.0439345,"Studies reporting on cognitive changes showed marginally significant positive changes in cognition, and those that reported BMI indicated potential improvements in cognition.
","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Batsis', 'Affiliation': 'Division of Geriatric Medicine, Department of Nutrition, School of Medicine, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Meredith N', 'Initials': 'MN', 'LastName': 'Roderka', 'Affiliation': 'Section of Weight & Wellness, 2331Department of Medicine, Dartmouth-Hitchcock, Lebanon, NH, USA.'}, {'ForeName': 'Vanessa K', 'Initials': 'VK', 'LastName': 'Rauch', 'Affiliation': 'Section of Weight & Wellness, 2331Department of Medicine, Dartmouth-Hitchcock, Lebanon, NH, USA.'}, {'ForeName': 'Lillian M', 'Initials': 'LM', 'LastName': 'Seo', 'Affiliation': '12285Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Xingyi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': '12285Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'DiMilia', 'Affiliation': 'Dartmouth Centers for Health and Aging, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Gooding', 'Affiliation': 'Dartmouth Centers for Health and Aging, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Gilbert-Diamond', 'Affiliation': '12285Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Auden C', 'Initials': 'AC', 'LastName': 'McClure', 'Affiliation': 'Section of Weight & Wellness, 2331Department of Medicine, Dartmouth-Hitchcock, Lebanon, NH, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Roth', 'Affiliation': '12285Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120983795']
295,33415419,Doppler-guided hemorrhoidal dearterialization with laser (HeLP): indications and clinical outcome in the long-term. Results of a multicenter trial.,"BACKGROUND


Doppler-guided hemorrhoidal laser procedure consists of sutureless closure of terminal branches of the superior hemorrhoidal artery by laser energy. Clinical results of patients treated with this procedure were analyzed at the completion of 2-year follow-up. Primary endpoint was resolution of symptoms and secondary endpoints were recurrence rate, type of recurrences, re-operation rate, and potential predictive factors for failure.
METHODS


Bleeding was assessed on a score from 0 to 4 (none = 0; < 1/month = 1; 1/week = 2; > 1/week = 3; 3-4/week = 4), frequency of hemorrhoid-related symptoms with a score of 0-3 (2/year = 1; 3-5/year = 2; < 5/year = 3). Constipation and fecal incontinence were assessed by means of validated scores. Quality of life and pain at defecation were assessed using a visual analog scale of 0-10 (0 = worst possible-10 = best possible quality of life and 0 = no pain-10 = worst pain imaginable, respectively). Recurrence rate and need for re-operation were reported. Potential predictive factors of failure were analyzed by means of univariate analysis.
RESULTS


Two-hundred-eighty-four patients (183 males, 101 females; mean age: 47.5 years) were included in the trial; 8 patients were lost at follow-up. Analysis of 276 patients who completed the 2-year follow-up showed an overall resolution of symptoms in 89.9% (248/276) of patients. Statistically significant improvement of quality of life, pain reduction, bleeding and frequency of acute symptoms were reported. Of 28 patients with persistent or recurrent symptoms, 12 had pain (4.35%), 10 had bleeding (3.6%) and 6 had increasing prolapse at defecation (2.2%). Eleven out of twenty-eight patients required additional surgery. Constipation and III-IV grade hemorrhoids were associated with statistically significant higher failure rates (p = 0.046 and 0.012, respectively). Better results were reported in patients reporting preoperative high-grade pain at evacuation.
CONCLUSIONS


The Doppler-guided hemorrhoidal laser procedure showed efficacy at long-term follow-up. It can be considered as 'first-line' treatment in patients with low-grade hemorrhoids suffering from bleeding, pain and recurrent acute symptoms in whom conservative treatment failed.",2022,"Constipation and III-IV grade hemorrhoids were associated with statistically significant higher failure rates (p = 0.046 and 0.012, respectively).","['Bleeding was assessed on a score from 0 to 4 (none\u2009=\u20090;\u2009<\u20091/month\u2009=\u20091; 1/week\u2009=\u20092;\u2009>\u20091/week\u2009=\u20093; 3-4/week\u2009=\u20094), frequency of hemorrhoid-related symptoms with a score of 0-3 (2/year\u2009=\u20091; 3-5/year\u2009=\u20092;\u2009<\u20095/year\u2009=\u20093', 'patients with low-grade hemorrhoids suffering from bleeding, pain and recurrent acute symptoms in whom conservative treatment failed', '276 patients', '28 patients with persistent or recurrent symptoms', 'Two-hundred-eighty-four patients (183 males, 101 females; mean age: 47.5\xa0years']","['Doppler-guided hemorrhoidal laser procedure', 'Doppler-guided hemorrhoidal dearterialization with laser (HeLP']","['additional surgery', 'resolution of symptoms', 'failure rates', 'bleeding', 'recurrence rate, type of recurrences, re-operation rate, and potential predictive factors for failure', 'visual analog scale', 'quality of life, pain reduction, bleeding and frequency of acute symptoms', 'Quality of life and pain at defecation', 'Constipation and fecal incontinence', 'overall resolution of symptoms', 'prolapse at defecation', 'Recurrence rate and need for re-operation', 'Constipation and III-IV grade hemorrhoids', 'pain']","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439589', 'cui_str': 'Recurrent acute'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C1562720', 'cui_str': 'Laser procedure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}]",8.0,0.0964066,"Constipation and III-IV grade hemorrhoids were associated with statistically significant higher failure rates (p = 0.046 and 0.012, respectively).","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Giamundo', 'Affiliation': 'Department of Colorectal Surgery, Policlinico di Monza, Monza, Italy. pgiamundo@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Braini', 'Affiliation': 'Department of General Surgery, AAS5 Friuli occidentale, Pordenone, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Calabrò', 'Affiliation': 'Humanitas Gavazzeni Institute, Bergamo, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Crea', 'Affiliation': ""Department of General Surgery, Sant'Anna Clinic, Brescia, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'De Nardi', 'Affiliation': 'Gastrointestinal Surgery, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Fabiano', 'Affiliation': 'Department of General Surgery, Evangelic International Hospital, Genoa, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Lippa', 'Affiliation': ""Department of General Surgery, Sant'Anna Clinic, Brescia, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Mastromarino', 'Affiliation': ""Vascular Surgery, San Salvatore Hospital, L'Aquila, Italy.""}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Tamburini', 'Affiliation': 'Gastrointestinal Surgery, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}]",Surgical endoscopy,['10.1007/s00464-020-08248-2']
296,33373276,Augmented Reduced-Intensity Regimen Does Not Improve Postallogeneic Transplant Outcomes in Acute Myeloid Leukemia.,"PURPOSE


Reduced-intensity conditioning (RIC) regimens have extended the curative potential of allogeneic stem-cell transplantation to older adults with high-risk acute myeloid leukemia (AML) and myelodysplasia (MDS) but are associated with a high risk of disease relapse. Strategies to reduce recurrence are urgently required. Registry data have demonstrated improved outcomes using a sequential transplant regimen, fludarabine/amsacrine/cytarabine-busulphan (FLAMSA-Bu), but the impact of this intensified conditioning regimen has not been studied in randomized trials.
PATIENTS AND METHODS


Two hundred forty-four patients (median age, 59 years) with high-risk AML (n = 164) or MDS (n = 80) were randomly assigned 1:1 to a fludarabine-based RIC regimen or FLAMSA-Bu. Pretransplant measurable residual disease (MRD) was monitored by flow cytometry (MFC-MRD) and correlated with outcome.
RESULTS


There was no difference in 2-year overall survival (hazard ratio 1.05 [85% CI, 0.80 to 1.38]  P  = .81) or cumulative incidence of relapse (CIR) (hazard ratio 0.94 [95%CI, 0.60 to 1.46]  P  = .81) between the control and FLAMSA-Bu arms. Detectable pretransplant MFC-MRD was associated with an increased CIR (2-year CIR 41.0%  v  20.0%,  P  = .01) in the overall trial cohort with a comparable prognostic impact when measured by an unsupervised analysis approach. There was no evidence of interaction between MRD status and conditioning regimen intensity for relapse or survival. Acquisition of full donor T-cell chimerism at 3 months abrogated the adverse impact of pretransplant MRD on CIR and overall survival.
CONCLUSION


The intensified RIC conditioning regimen, FLAMSA-Bu, did not improve outcomes in adults transplanted for high-risk AML or MDS regardless of pretransplant MRD status. Our data instead support the exploration of interventions with the ability to accelerate acquisition of full donor T-cell chimerism as a tractable strategy to improve outcomes in patients allografted for AML.",2021,"There was no difference in 2-year overall survival (hazard ratio 1.05 [85% CI, 0.80 to 1.38]  P  = .81) or cumulative incidence of relapse (CIR) (hazard ratio 0.94","['older adults with high-risk acute myeloid leukemia (AML) and myelodysplasia (MDS', 'Acute Myeloid Leukemia', 'Two hundred forty-four patients (median age, 59 years) with high-risk AML (n = 164) or MDS (n = 80']","['fludarabine-based RIC regimen or FLAMSA-Bu', 'intensity conditioning (RIC) regimens', 'fludarabine/amsacrine/cytarabine-busulphan (FLAMSA-Bu']","['CIR and overall survival', 'Pretransplant measurable residual disease (MRD', 'Detectable pretransplant MFC-MRD', '2-year overall survival', 'CIR', 'cumulative incidence of relapse (CIR', 'Postallogeneic Transplant Outcomes', 'relapse or survival', 'Acquisition of full donor T-cell chimerism']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0002699', 'cui_str': 'Amsacrine'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0333678', 'cui_str': 'Cellular mosaicism'}]",80.0,0.241521,"There was no difference in 2-year overall survival (hazard ratio 1.05 [85% CI, 0.80 to 1.38]  P  = .81) or cumulative incidence of relapse (CIR) (hazard ratio 0.94","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Craddock', 'Affiliation': 'Centre for Clinical Haematology, Queen Elizabeth Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Jackson', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, United Kingdom.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Loke', 'Affiliation': 'Centre for Clinical Haematology, Queen Elizabeth Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Shamyla', 'Initials': 'S', 'LastName': 'Siddique', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, United Kingdom.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hodgkinson', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, United Kingdom.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Andrew', 'Affiliation': 'Institute of Immunology and Immunotherapy, University of Birmingham, United Kingdom.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Nagra', 'Affiliation': 'Centre for Clinical Haematology, Queen Elizabeth Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Malladi', 'Affiliation': 'Addenbrookes Hospital, Cambridge, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Peniket', 'Affiliation': 'Churchill Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gilleece', 'Affiliation': ""St James's Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Rahuman', 'Initials': 'R', 'LastName': 'Salim', 'Affiliation': 'Royal Liverpool University Hospital, United Kingdom.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Tholouli', 'Affiliation': 'Manchester Royal Infirmary, Manchester, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Potter', 'Affiliation': 'Kings College Hospital, London, United Kingdom.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Crawley', 'Affiliation': 'Addenbrookes Hospital, Cambridge, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Protheroe', 'Affiliation': 'Bristol Haematology and Oncology Centre, United Kingdom.'}, {'ForeName': 'Paresh', 'Initials': 'P', 'LastName': 'Vyas', 'Affiliation': 'Churchill Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hunter', 'Affiliation': 'Leicester Royal Infirmary, United Kingdom.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Parker', 'Affiliation': 'Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'University Hospital Wales, United Kingdom.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Pavlu', 'Affiliation': 'Imperial College Hospital, London, Unite Kingdom.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'Centre for Clinical Haematology, Nottingham, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Dillon', 'Affiliation': ""Department of Medical and Molecular Genetics, King's College, London, United Kingdom.""}, {'ForeName': 'Naeem', 'Initials': 'N', 'LastName': 'Khan', 'Affiliation': 'Institute of Immunology and Immunotherapy, University of Birmingham, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'McCarthy', 'Affiliation': 'Institute of Immunology and Immunotherapy, University of Birmingham, United Kingdom.'}, {'ForeName': 'Sylvie D', 'Initials': 'SD', 'LastName': 'Freeman', 'Affiliation': 'Institute of Immunology and Immunotherapy, University of Birmingham, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02308']
297,33387155,Ultrasound guided paralaryngeal pressure versus cricoid pressure on the occlusion of esophagus: a crossover study.,"The primary objective of this study is to compare the effectiveness of cricoid pressure (CP) and paralaryngeal pressure (PLP) on occlusion of eccentric esophagus in patients under general anesthesia (GA). Secondary objectives include the prevalence of patients with central or eccentric esophagus both before and after GA, and the success rate of CP in occluding centrally located esophagus in patients post GA. Fifty-one ASA physical status I and II patients, undergoing GA for elective surgery were enrolled in this study. Ultrasonography imaging were performed to determine the position of the esophagus relative to the trachea: (i) before induction of GA, (ii) after GA before external CP maneuver, (iii) after GA with CP, and (iv) after GA with PLP. CP was applied to all patients whilst PLP via fingertip technique was only applied to patients with an eccentric esophagus. Among a total of 51 patients, 28 of them (55%) had eccentric esophagus pre GA, while this number increase to 33 (65%) after induction of GA. CP success rate was 100% in 18 patients with central esophagus post GA versus 27% in 33 patients with eccentric esophagus post GA (P<0.00001). Overall success rate for CP was 53%. In 33 patients with eccentric esophagus anatomy post GA, PLP success rate was 30% compared with 27% with CP (P=1.000). Ultrasound guided PLP fingertips technique was not effective in patients with an eccentrically located esophagus post GA. Ultrasound guided CP achieved 100% success rate in patients with a centrally located esophagus post GA.",2022,CP success rate was 100% in 18 patients with central esophagus post GA versus 27% in 33 patients with eccentric esophagus post GA (P<0.00001).,"['Fifty-one ASA physical status I and II patients, undergoing GA for elective surgery', 'patients with an eccentrically located esophagus post GA', 'patients under general anesthesia (GA']","['Ultrasonography imaging', 'cricoid pressure (CP) and paralaryngeal pressure (PLP', 'Ultrasound guided PLP fingertips technique', 'Ultrasound guided paralaryngeal pressure versus cricoid pressure', 'CP', 'Ultrasound guided CP']","['prevalence of patients with central or eccentric esophagus', 'Overall success rate', 'PLP success rate', 'success rate of CP', 'CP success rate', 'eccentric esophagus pre GA']","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0729895', 'cui_str': 'Tip of finger'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]",18.0,0.0258749,CP success rate was 100% in 18 patients with central esophagus post GA versus 27% in 33 patients with eccentric esophagus post GA (P<0.00001).,"[{'ForeName': 'Siu Min', 'Initials': 'SM', 'LastName': 'Lim', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia. limsiumin@gmail.com.'}, {'ForeName': 'Boon Keat', 'Initials': 'BK', 'LastName': 'Ng', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Chao Chia', 'Initials': 'CC', 'LastName': 'Cheong', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Tyng Yan', 'Initials': 'TY', 'LastName': 'Ng', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Chew Yin', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00623-7']
298,33392835,Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials.,"PURPOSE


Abemaciclib in combination with endocrine therapy (ET) has demonstrated significant efficacy benefits in HR+ , HER2- advanced breast cancer patients in the Phase 3 studies MONARCH 2 (fulvestrant as ET) and MONARCH 3 (letrozole or anastrozole as ET). Here, we report age-specific safety and efficacy outcomes.
METHODS


Exploratory analyses of MONARCH 2 and 3 were performed for 3 age groups (<65, 65-74, and ≥75 years). For safety, data were pooled from both studies; for efficacy, a subgroup analysis of PFS was performed for each trial independently.
RESULTS


Pooled safety data were available for 1152 patients. Clinically relevant diarrhea (Grade 2/3) was higher in older patients receiving abemaciclib + ET (<65, 39.5%; 65-74, 45.2%; ≥75, 55.4%) versus placebo + ET (<65, 6.8%; 65-74, 4.5%; ≥75, 16.0%). Nausea, decreased appetite, and venous thromboembolic events were all moderately higher in older patients. Neutropenia (Grade ≥ 3) did not differ as a function of age in the abemaciclib + ET arm (<65, 25.8%; 65-74, 27.4%; ≥75, 18.1%). Dose adjustments and discontinuation rates were slightly higher in older patients. Abemaciclib + ET improved PFS compared with placebo + ET independent of patient age, with no significant difference in abemaciclib treatment effect between the 3 age groups (MONARCH 2: interaction p-value, 0.695; MONARCH 3: interaction p-value, 0.634). Estimated hazard ratios ranged from 0.523-0.633 (MONARCH 2) and 0.480-0.635 (MONARCH 3).
CONCLUSIONS


While higher rates of adverse events were reported in older patients, they were manageable with dose adjustments and concomitant medication. Importantly, a consistent efficacy benefit was observed across all age groups.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov: NCT02107703 (first posted April 8, 2014) and NCT02246621 (first posted September 23, 2014).",2021,"Estimated hazard ratios ranged from 0.523-0.633 (MONARCH 2) and 0.480-0.635 (MONARCH 3).
","['older patients', '1152 patients', 'HER2- advanced breast cancer patients', 'Exploratory analyses of MONARCH 2 and 3 were performed for 3 age groups (<65, 65-74, and\u2009≥75\xa0years', 'older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer']","['endocrine therapy (ET', 'MONARCH 3 (letrozole or anastrozole', 'placebo', 'abemaciclib plus endocrine therapy']","['PFS', 'Neutropenia', 'Clinically relevant diarrhea', 'efficacy benefit', 'abemaciclib treatment effect', 'adverse events', 'Safety and efficacy', 'discontinuation rates', 'Nausea, decreased appetite, and venous thromboembolic events']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}]",,0.0784905,"Estimated hazard ratios ranged from 0.523-0.633 (MONARCH 2) and 0.480-0.635 (MONARCH 3).
","[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Department of Oncology, Mayo Clinic, 200 First St. S.W, Rochester, MN, 55905, USA. Goetz.Matthew@mayo.edu.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Okera', 'Affiliation': 'Adelaide Cancer Center, Adelaide, Australia.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wildiers', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Institut de Cancerologie de L'Ouest-René Gauducheau, Saint Herblain, France.""}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Grischke', 'Affiliation': ""Women's Hospital, University Hospital Tübingen, Tübingen, Germany.""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Manso', 'Affiliation': '12 de Octubre University Hospital, Madrid, Spain.'}, {'ForeName': 'Valérie A M', 'Initials': 'VAM', 'LastName': 'André', 'Affiliation': 'Eli Lilly and Company, Paris, France.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Chouaki', 'Affiliation': 'Eli Lilly and Company, Paris, France.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'San Antonio', 'Affiliation': 'Eli Lilly and Company, Madrid, Spain.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Breast Cancer Unit, Kyoto University Hospital, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}]",Breast cancer research and treatment,['10.1007/s10549-020-06029-y']
299,33389399,CTCs-oriented adjuvant personalized cytostatic therapy non-metastatic breast cancer patients: continuous non-randomized prospective study and prospective randomized controlled study.,"THE AIM


To conduct a prospective randomized controlled study of the optimization of adjuvant therapy in patients with non-metastatic breast cancer, taking into account the presence of circulating tumor cells (CTCs) with an assessment of tumor-specific OS and DFS.
MATERIALS


Stage 1 Continuous non-randomized prospective study (n = 102) to study the clinical and prognostic value of CTCs and evaluate the effectiveness of adjuvant systemic therapy in relation to CTC eradication; Stage 2 Prospective randomized controlled study (n = 128) of optimization of adjuvant therapy taking into account CTCs with an assessment of the effectiveness of the standard therapy and an optimized therapy regimen.
RESULTS


Monitoring of CTCs during adjuvant drug treatment has established that a significant decrease in the frequency of CTC identification can be achieved only by sequential administration of anthracyclines and taxanes (paclitaxel) AC-T, which allows reducing CTCs compared to other regimens from 52.6 to 15.8% (p = 0.006). CTC-oriented personalized adjuvant therapy in the experimental group, based on the timely transition from an ineffective adjuvant chemotherapy regimen to taxanes, as well as additional monochemotherapy with gemcitabine can achieve 100% eradication CTCs. In the adjuvant therapy experimental group taking into account CTCs (n = 68), the OS 5-year tumor-specific rate was 90.3 ± 3.8%, (control group 78.7 ± 3.9%, p = 0.036). DFS tumor-specific in the experimental group was 88.0 ± 4.4%, (control group 80.6 ± 3.3%, p = 0.023).
CONCLUSIONS


The use of the method of treatment of CTC-oriented personalized adjuvant therapy for non-metastatic breast cancer makes it possible to reliably increase DFS 5-year by 7.4% and OS 5-year by 11.6%.",2021,"In the adjuvant therapy experimental group taking into account CTCs (n = 68), the OS 5-year tumor-specific rate was 90.3 ± 3.8%, (control group 78.7 ± 3.9%, p = 0.036).","['patients with non-metastatic breast cancer', 'non-metastatic breast cancer patients']","['adjuvant systemic therapy', 'gemcitabine', 'CTCs-oriented adjuvant personalized cytostatic therapy', 'adjuvant therapy', 'CTC-oriented personalized adjuvant therapy', 'anthracyclines and taxanes (paclitaxel) AC-T']","['OS 5-year tumor-specific rate', 'frequency of CTC identification', 'DFS tumor-specific', 'DFS 5-year']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0010858', 'cui_str': 'Cytostatics'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}]",,0.0141276,"In the adjuvant therapy experimental group taking into account CTCs (n = 68), the OS 5-year tumor-specific rate was 90.3 ± 3.8%, (control group 78.7 ± 3.9%, p = 0.036).","[{'ForeName': 'Ya A', 'Initials': 'YA', 'LastName': 'Shliakhtunou', 'Affiliation': 'Department of Oncology, Educational Establishment ""Vitebsk State Medical University"", Frunze Av., 27, 210009, Vitebsk, Republic of Belarus. Evgenij-shlyakhtunov@yandex.ru.'}]",Breast cancer research and treatment,['10.1007/s10549-020-06036-z']
300,33403921,"Reconfiguration of Electroencephalography Microstate Networks after Breath-Focused, Digital Meditation Training.","Sustained attention and working memory were improved in young adults after they engaged in a recently developed, closed-loop, digital meditation practice. Whether this type of meditation also has a sustained effect on dominant resting-state networks is currently unknown. In this study, we examined the resting brain states before and after a period of breath-focused, digital meditation training versus placebo using an electroencephalography (EEG) microstate approach. We found topographical changes in postmeditation rest, compared with baseline rest, selectively for participants who were actively involved in the meditation training and not in participants who engaged with an active, expectancy-match, placebo control paradigm. Our results suggest a reorganization of brain network connectivity after 6 weeks of intensive meditation training in brain areas, mainly including the right insula, the superior temporal gyrus, the superior parietal lobule, and the superior frontal gyrus bilaterally. These findings provide an opening for the development of a novel noninvasive treatment of neuropathological states by low-cost, breath-focused, digital meditation practice, which can be monitored by the EEG microstate approach.",2021,"We found topographical changes in post-meditation rest compared to baseline rest, selectively for participants who were actively involved in the meditation training and not in participants who engaged with an active, expectancy-match placebo control paradigm.","['participants who were actively involved in the meditation training and not in participants who engaged with an active, expectancy-match placebo control paradigm']","['digital meditation training vs. placebo', 'intensive meditation training', 'digital meditation training']",['Sustained attention and working memory'],"[{'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.0484518,"We found topographical changes in post-meditation rest compared to baseline rest, selectively for participants who were actively involved in the meditation training and not in participants who engaged with an active, expectancy-match placebo control paradigm.","[{'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Bréchet', 'Affiliation': 'Functional Brain Mapping Laboratory, Department of Fundamental Neuroscience, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ziegler', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Simon', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Brunet', 'Affiliation': 'Functional Brain Mapping Laboratory, Department of Fundamental Neuroscience, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gazzaley', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Christoph M', 'Initials': 'CM', 'LastName': 'Michel', 'Affiliation': 'Functional Brain Mapping Laboratory, Department of Fundamental Neuroscience, University of Geneva, Geneva, Switzerland.'}]",Brain connectivity,['10.1089/brain.2020.0848']
301,33420829,Can cryoprevention of oral mucositis be obtained at a higher temperature?,"OBJECTIVES


Ice chips (IC) have successfully been used to prevent the development of chemotherapy-induced oral mucositis (OM). Although effective, IC entails several shortcomings and may open avenues for systemic infections as the water used may be contaminated by microorganisms, which may jeopardise the medical rehabilitation of an already immunosuppressed patient. This study aimed to investigate the efficacy and tolerability profile of a novel intraoral cooling device (ICD).
SUBJECTS AND METHODS


In total, 20 healthy volunteers were enrolled in this randomised crossover study. Intraoral temperatures were registered using an IR camera, at baseline and following 30 and 60 min of cooling with the ICD, set to 8 °C or 15 °C. Following each cooling session, tolerability was assessed using a questionnaire.
RESULTS


A statistically significant difference in the intraoral temperature was observed using 8 °C compared with 15 °C, following both 30 (1.87 °C, p < 0.001) and 60 min (2.48 °C, p < 0.001) of cooling. Thus, the difference of the intraoral temperatures was less than the 7 °C difference between 8 °C and 15 °C. Furthermore, 60 min of cooling with 15 °C compared with 8 °C was better tolerated and preferred by 15 out of 20 participants (p < 0.001).
CONCLUSION


Cooling was better tolerated when the ICD was set to 15 °C compared with 8 °C, although the difference in reduction of the intraoral mucosal temperature was marginal and may not affect cryoprevention of oral mucositis.
CLINICAL RELEVANCE


The ICD has the potential to improve the care for patients with cancer at high risk of developing OM.",2021,"A statistically significant difference in the intraoral temperature was observed using 8 °C compared with 15 °C, following both 30 (1.87 °C, p < 0.001) and 60 min (2.48 ","['20 healthy volunteers', 'patients with cancer at high risk of developing OM']",['novel intraoral cooling device (ICD'],"['efficacy and tolerability profile', 'intraoral temperature', 'intraoral mucosal temperature', 'intraoral temperatures', 'tolerability', 'tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}]",20.0,0.0359683,"A statistically significant difference in the intraoral temperature was observed using 8 °C compared with 15 °C, following both 30 (1.87 °C, p < 0.001) and 60 min (2.48 ","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mahdi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Institute of Odontology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden, Medicinaregatan 12D, PO Box 450, 405 30, Gothenburg, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stübner', 'Affiliation': 'Department of Oral Medicine and Pathology, Institute of Odontology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bergling', 'Affiliation': 'Department of Oral Medicine and Pathology, Institute of Odontology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jontell', 'Affiliation': 'Department of Oral Medicine and Pathology, Institute of Odontology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Walladbegi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Institute of Odontology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden, Medicinaregatan 12D, PO Box 450, 405 30, Gothenburg, Sweden. java.walladbegi@odontologi.gu.se.'}]",Clinical oral investigations,['10.1007/s00784-020-03765-9']
302,33417481,Early Interdisciplinary Supportive Care in Patients With Previously Untreated Metastatic Esophagogastric Cancer: A Phase III Randomized Controlled Trial.,"PURPOSE


Effective interventions to improve prognosis in metastatic esophagogastric cancer (EGC) are urgently needed. We assessed the effect of the early integration of interdisciplinary supportive care for patients with metastatic EGC on overall survival (OS).
PATIENTS AND METHODS


An open-label, phase III, randomized, controlled trial was conducted at Peking University Cancer Hospital & Institute. Patients with previously untreated metastatic EGC were enrolled. Patients were randomly assigned (2:1) to either early interdisciplinary supportive care (ESC) integrated into standard oncologic care or standard care (SC). ESC was provided by a team of GI medical oncologists, oncology nurse specialists, dietitians, and psychologists; patients in the SC group received standard oncologic care alone. The primary end point was OS in the intention-to-treat population.
RESULTS


Between April 16, 2015, and December 29, 2017, 328 patients were enrolled: 214 in the ESC group and 114 in the SC group. At the data cutoff date of January 26, 2019, 15 (5%) patients were lost to follow-up. The median number of cycles of first-line chemotherapy was five (interquartile range [IQR], 4-7) in the ESC group and four (IQR, 2-6) in the SC group. The median OS was 14.8 months (95% CI, 13.3 to 16.3) in the ESC group and 11.9 months (95% CI, 9.6 to 13.6) in the SC group (hazard ratio, 0.68; 95% CI, 0.51 to 0.9;  P  = .021).
CONCLUSION


The early integration of interdisciplinary supportive care is an effective intervention with survival benefits for patients with metastatic EGC. Further optimization and standardization are warranted.",2021,"The median OS was 14.8 months (95% CI, 13.3 to 16.3) in the ESC group and 11.9 months (95% CI, 9.6 to 13.6) in the SC group (hazard ratio, 0.68; 95% CI, 0.51 to 0.9;  P  = .021).
","['Patients With Previously Untreated Metastatic Esophagogastric Cancer', 'Peking University Cancer Hospital & Institute', 'patients with metastatic EGC on overall survival (OS', 'metastatic esophagogastric cancer (EGC', 'Patients with previously untreated metastatic EGC were enrolled', '328 patients were enrolled', 'patients with metastatic EGC', 'Between April 16, 2015, and December 29, 2017']","['standard oncologic care alone', 'early interdisciplinary supportive care (ESC) integrated into standard oncologic care or standard care (SC', 'ESC']","['median number of cycles of first-line chemotherapy', 'OS in the intention-to-treat population', 'median OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",328.0,0.102831,"The median OS was 14.8 months (95% CI, 13.3 to 16.3) in the ESC group and 11.9 months (95% CI, 9.6 to 13.6) in the SC group (hazard ratio, 0.68; 95% CI, 0.51 to 0.9;  P  = .021).
","[{'ForeName': 'Zhihao', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Department of Clinical Nutrition, Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Xiaotian', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Xin', 'Affiliation': 'Department of Clinical Nutrition, Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Psycho-Oncology, Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Yanshuo', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Jiao', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Tianqi', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Precision Scientific (Beijing) Co, Ltd, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': 'Department of Psycho-Oncology, Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Nutrition, Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Changsong', 'Initials': 'C', 'LastName': 'Qi', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Jifang', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Xicheng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Psycho-Oncology, Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai-Dian District, Beijing, China.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01254']
303,33386288,Update from PSMA-SRT Trial NCT03582774: A Randomized Phase 3 Imaging Trial of Prostate-specific Membrane Antigen Positron Emission Tomography for Salvage Radiation Therapy for Prostate Cancer Recurrence Powered for Clinical Outcome.,"The purpose of this randomized trial is to evaluate the success rate of salvage radiation therapy for recurrence of prostate cancer after radical prostatectomy, with and without planning based on prostate-specific membrane antigen positron emission tomography/computed tomography. Enrollment has been completed and patients are being followed for 5yr.",2021,"The purpose of this randomized trial is to evaluate the success rate of salvage radiation therapy for recurrence of prostate cancer after radical prostatectomy, with and without planning based on prostate-specific membrane antigen positron emission tomography/computed tomography.",[],"['salvage radiation therapy', 'radical prostatectomy, with and without planning based on prostate-specific membrane antigen positron emission tomography/computed tomography', 'Prostate-specific Membrane Antigen Positron Emission Tomography']",[],[],"[{'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",[],,0.109863,"The purpose of this randomized trial is to evaluate the success rate of salvage radiation therapy for recurrence of prostate cancer after radical prostatectomy, with and without planning based on prostate-specific membrane antigen positron emission tomography/computed tomography.","[{'ForeName': 'Jeremie', 'Initials': 'J', 'LastName': 'Calais', 'Affiliation': 'Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA; Institute of Urologic Oncology, University of California, Los Angeles, Los Angeles, CA, USA; Physics and Biology in Medicine Interdepartmental Graduate Program, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA. Electronic address: jcalais@mednet.ucla.edu.'}, {'ForeName': 'Wesley R', 'Initials': 'WR', 'LastName': 'Armstrong', 'Affiliation': 'Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Amar U', 'Initials': 'AU', 'LastName': 'Kishan', 'Affiliation': 'Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA; Institute of Urologic Oncology, University of California, Los Angeles, Los Angeles, CA, USA; Department of Radiation Oncology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Kiara M', 'Initials': 'KM', 'LastName': 'Booker', 'Affiliation': 'Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Hope', 'Affiliation': 'Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco, CA, USA; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, USA; San Francisco VA Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Wolfgang P', 'Initials': 'WP', 'LastName': 'Fendler', 'Affiliation': 'Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA; Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Elashoff', 'Affiliation': 'Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA; Department of Medicine Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Nicholas G', 'Initials': 'NG', 'LastName': 'Nickols', 'Affiliation': 'Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA; Institute of Urologic Oncology, University of California, Los Angeles, Los Angeles, CA, USA; Department of Radiation Oncology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA; Department of Radiation Oncology, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Czernin', 'Affiliation': 'Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA; Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA; Institute of Urologic Oncology, University of California, Los Angeles, Los Angeles, CA, USA; Physics and Biology in Medicine Interdepartmental Graduate Program, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}]",European urology focus,['10.1016/j.euf.2020.12.009']
304,33392969,The Cost-Effectiveness of Adapting and Implementing a Brief Intervention to Target Frequent Alcohol Use Among Persons with HIV in Vietnam.,"Brief interventions to reduce frequent alcohol use among persons with HIV (PWH) are evidence-based, but resource-constrained settings must contend with competition for health resources. We evaluated the cost-effectiveness of two intervention arms compared to the standard of care (SOC) in a three-arm randomized control trial targeting frequent alcohol use in PWH through increasing the percent days abstinent from alcohol and viral suppression. We estimated incremental cost per quality-adjusted life year (QALY) gained from a modified societal perspective and a 1-year time horizon using a Markov model of health outcomes. The two-session brief intervention (BI), relative to the six-session combined intervention (CoI), was more effective and less costly; the estimated incremental cost-effectiveness of the BI relative to the SOC, was $525 per QALY gained. The BI may be cost-effective for the HIV treatment setting; the health utility gained from viral suppression requires further exploration.",2021,The BI may be cost-effective for the HIV treatment setting; the health utility gained from viral suppression requires further exploration.,"['Persons with HIV in Vietnam', 'persons with HIV (PWH']",['standard of care (SOC'],"['Cost-Effectiveness', 'cost-effectiveness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.014776,The BI may be cost-effective for the HIV treatment setting; the health utility gained from viral suppression requires further exploration.,"[{'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Blackburn', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, CB #7420, Chapel Hill, NC, 27599-7420, USA. nblackbu@live.unc.edu.'}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, CB #7420, Chapel Hill, NC, 27599-7420, USA.'}, {'ForeName': 'Quynh', 'Initials': 'Q', 'LastName': 'Bui', 'Affiliation': 'University of North Carolina Project Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Hutton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Radhika P', 'Initials': 'RP', 'LastName': 'Tampi', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Teerada', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, CB #7420, Chapel Hill, NC, 27599-7420, USA.'}, {'ForeName': 'Tran Viet', 'Initials': 'TV', 'LastName': 'Ha', 'Affiliation': 'University of North Carolina Project Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Golden', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, CB #7420, Chapel Hill, NC, 27599-7420, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Golin', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, CB #7420, Chapel Hill, NC, 27599-7420, USA.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Gottfredson', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, CB #7420, Chapel Hill, NC, 27599-7420, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03139-y']
305,33417663,Effect of Protein Intake on Visceral Abdominal Fat and Metabolic Biomarkers in Older Men With Functional Limitations: Results From a Randomized Clinical Trial.,"BACKGROUND


It remains controversial whether high protein diets improve cardiometabolic profile. We investigated whether increasing protein intake to 1.3 g/kg/day in functionally limited older adults with usual protein intake ≤RDA (0.8 g/kg/day) improves visceral fat accumulation and serum cardiovascular risk markers more than the recommended daily allowance (RDA).
METHODS


The Optimizing Protein Intake in Older Men Trial was a placebo-controlled, randomized trial in which 92 functionally limited men, ≥65 years, with usual protein intake ≤RDA were randomized for 6 months to: 0.8 g/kg/day protein plus placebo; 1.3 g/kg/day protein plus placebo; 0.8 g/kg/day protein plus testosterone enanthate 100 mg weekly; or 1.3 g/kg/day protein plus testosterone enanthate 100 mg weekly. In this substudy, metabolic and inflammatory serum markers were measured in 77 men, and visceral adipose tissue (VAT) was assessed using dual-energy x-ray absorptiometry in 56 men.
RESULTS


Treatment groups were similar in their baseline characteristics. Randomization to 1.3 g/kg/day protein group was associated with greater reduction in VAT compared to 0.8 g/kg/day group (between-group difference: -17.3 cm2, 95% confidence interval [CI]: -29.7 to -4.8 cm2, p = .008), regardless of whether they received testosterone or placebo. Changes in fasting glucose, fasting insulin, HOMA-IR, leptin, adiponectin, IL-6, and hs-CRP did not differ between the 0.8 versus 1.3 g/kg/day protein groups regardless of testosterone use.
CONCLUSIONS


Protein intake >RDA decreased VAT in functionally limited older men but did not improve cardiovascular disease risk markers.
CLINICAL TRIALS REGISTRATION NUMBER


NCT01275365.",2021,"Changes in fasting glucose, fasting insulin, HOMA-IR, leptin, adiponectin, IL-6 and hs-CRP did not differ between the 0.8 vs 1.3-g/kg/d protein groups regardless of testosterone use.
","['Older Men', '77 men, and visceral adipose tissue (VAT) was assessed using dual energy X-ray absorptiometry in 56 men', 'functionally-limited older adults with usual protein intake ≤RDA (0.8-g/kg/day', 'Older Men with Functional Limitations', '92 functionally-limited men, >65-years, with usual protein intake ≤RDA']","['testosterone or placebo', 'Protein Intake', 'testosterone enanthate 100-mg weekly; or 1.3-g/kg/day protein plus testosterone enanthate 100-mg weekly', 'placebo']","['visceral fat accumulation and serum cardiovascular risk markers', 'fasting glucose, fasting insulin, HOMA-IR, leptin, adiponectin, IL-6 and hs-CRP', 'cardiovascular disease risk markers', 'cardiometabolic profile', 'VAT', 'Visceral Abdominal Fat and Metabolic Biomarkers']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C1532536', 'cui_str': 'g/kg/day'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0076189', 'cui_str': 'Testosterone enanthate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C1532536', 'cui_str': 'g/kg/day'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}]",92.0,0.404636,"Changes in fasting glucose, fasting insulin, HOMA-IR, leptin, adiponectin, IL-6 and hs-CRP did not differ between the 0.8 vs 1.3-g/kg/d protein groups regardless of testosterone use.
","[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Department of Medicine, Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Pencina', 'Affiliation': ""Department of Medicine, Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Zhuoying', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Medicine, Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Apovian', 'Affiliation': 'Department of Medicine, Section of Endocrinology, Diabetes and Nutrition, Boston Medical Center, Massachusetts, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Travison', 'Affiliation': 'Department of Medicine, Institute for Aging Research, Hebrew SeniorLife, Division of Gerontology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Storer', 'Affiliation': ""Department of Medicine, Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Gagliano-Jucá', 'Affiliation': ""Department of Medicine, Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""Department of Medicine, Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Department of Medicine, Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glab007']
306,33373708,"The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial.","OBJECTIVE


To report the results of a multicenter, randomized, controlled trial with a temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel) compared to sham for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.
MATERIALS AND METHODS


Men 50 years or older were randomized 2:1 between iTind and sham procedure arms. A self-expanding, temporary nitinol device was placed for 5-7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 1.5, 3, and 12 months postoperatively using the IPSS, peak urinary flow rate, residual urine, quality of life, and the International Index of Erectile Function. Unblinding occurred at 3 months.
RESULTS


A total of 175 men (mean age 61.1 ± 6.5) participated (118 iTind vs 57 sham). A total of 78.6% of patients in the iTind arm showed a reduction of ≥3 points in IPSS, vs 60% of patients in the control arm at 3 months. At 12 months, the iTind group reported a 9.25 decrease in IPSS (P< .0001), a 3.52ml/s increase in peak urinary flow rate (P < .0001) and a 1.9-point reduction in quality of life (P < .0001). Adverse events were typically mild and transient, most Clavien-Dindo grade I or II, in 38.1% of patients in the iTind arm and 17.5% in the control arm. No de novo ejaculatory or erectile dysfunction occurred.
CONCLUSION


Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function.",2021,"CONCLUSIONS


Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function.","['lower urinary tract symptoms secondary to benign prostatic hyperplasia', 'A total of 175 men (mean age 61.1±6.5) participated (118 iTind vs 57 sham', 'Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia', 'Men 50 years or older']","['Nitinol Device', 'temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel']","['IPSS', 'novo ejaculatory or erectile dysfunction', 'PFR', 'Adverse events', 'IPSS, peak urinary flow rate (PFR), residual urine, quality of life (QoL), and the International Index of Erectile Function (IIEF', 'reduction of ≥3 points in IPSS']","[{'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1136140', 'cui_str': 'Long-Term Depression, Neurophysiologic'}, {'cui': 'C0022271', 'cui_str': 'Israel'}]","[{'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",175.0,0.1948,"CONCLUSIONS


Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function.","[{'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Chughtai', 'Affiliation': 'Department of Urology, NY-Presbyterian Hospital, Weill Cornell Medical Center, New York, NY. Electronic address: bic9008@med.cornell.edu.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Elterman', 'Affiliation': 'Division of Urology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': 'Carolina Urology Research Center, Myrtle Beach, SC.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Gittleman', 'Affiliation': 'South Florida Medical Research, Miami, FL.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Motola', 'Affiliation': 'Mt Sinai Hospital, New York, NY.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Pike', 'Affiliation': ""St John's Episcopal, New York, NY.""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Hermann', 'Affiliation': 'Clinical Research Center of Florida, Miami, FL.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Terrens', 'Affiliation': 'Premier Urology Group, New Jersey, NJ.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Kohan', 'Affiliation': 'Integrated Medical Professionals, Long Island, NY.'}, {'ForeName': 'Ricardo R', 'Initials': 'RR', 'LastName': 'Gonzalez', 'Affiliation': 'Houston Metro Urology, Houston, TX.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Katz', 'Affiliation': 'NYU Winthrop Hospital, Long Island, NY.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Schiff', 'Affiliation': 'NYU Winthrop Hospital, Long Island, NY.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Goldfischer', 'Affiliation': 'Premier Medical Group of the Hudson Valley, Poughkeepsie, NY.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Grunberger', 'Affiliation': 'New York Methodist Hospital, Brooklyn, NY.'}, {'ForeName': 'Le Mai', 'Initials': 'LM', 'LastName': 'Tu', 'Affiliation': 'Sherbrooke University Hospital, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Alshak', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Kaminetzky', 'Affiliation': 'Manhattan Medical Research, Manhattan, NY.'}]",Urology,['10.1016/j.urology.2020.12.022']
307,33403940,Impact of extended-release niacin on immune activation in HIV-infected immunological non-responders on effective antiretroviral therapy.,"BACKGROUND


Background:  Tryptophan (Trp) catabolism into immunosuppressive kynurenine (Kyn) is involved in immune dysregulation during HIV infection. Niacin (vitamin B3) could control the excess of tryptophan depletion and represents a potential strategy to improve immune functions and CD4 count recovery in immunological non-responder HIV-infected individuals on antiretroviral therapy (ART).
METHODS


Methods:  In the CTN PT006 phase 2 pilot randomized trial, 20 adults on ART with CD4 ≤ 350 cells/µl, despite an undetectable viral load (VL) for at least 3 months, received 2000 mg of extended-release (ER)-niacin orally once daily for 24 weeks. Side effects, VL, CD4/CD8 counts, lipid profile, T-cell activation and senescence, Tregs and Th17 cell frequencies, Kyn/Trp ratio, and levels of IL-6, IP-10, sST2, I-FABP, and LBP were assessed following ER-niacin treatment.
RESULTS


Results:  Thirteen participants completed the study. Treatment was interrupted in 4 patients due to loss of follow-up or personal reasons and 3 patients were discontinued due to comorbidity risks. All participants maintained a VL < 40 copies/ml, while ER-niacin did not affect CD4 and CD8 cell counts. Plasma levels of triglycerides, total, and LDL cholesterol significantly decreased, following ER-niacin treatment. ER-niacin also diminished Kyn plasma levels and slightly decreased CD4 T-cell activation. However, no improvement in CD8 subsets, Kyn/Trp ratio, Th17/Treg balance, and plasma inflammatory markers was observed.
CONCLUSIONS


Conclusions:  Although ER-niacin combined with ART was well-tolerated among immune non-responders and decreased plasma lipids, it did not improve systemic inflammation, Kyn/Trp ratio, and CD4 cell recovery. Overall, ER-niacin was not effective to overcome chronic inflammation in PLWH.",2020,"Plasma levels of triglycerides, total, and LDL cholesterol significantly decreased, following ER-niacin treatment.","['HIV-infected immunological non-responders on effective antiretroviral therapy', '20 adults on ART with CD4\u2009≤\u2009350 cells/µl, despite an undetectable viral load (VL) for at least 3\u2009months, received', 'Thirteen participants completed the study']","['ER-niacin', '2000\u2009mg of extended-release (ER)-niacin orally once daily for 24\u2009weeks', 'Niacin (vitamin B3', 'extended-release niacin']","['Kyn plasma levels', 'immune activation', 'CD4 and CD8 cell counts', 'plasma lipids', 'Side effects, VL, CD4/CD8 counts, lipid profile, T-cell activation and senescence, Tregs and Th17 cell frequencies, Kyn/Trp ratio, and levels of IL-6, IP-10, sST2, I-FABP, and LBP', 'CD8 subsets, Kyn/Trp ratio, Th17/Treg balance, and plasma inflammatory markers', 'Plasma levels of triglycerides, total, and LDL cholesterol', 'systemic inflammation, Kyn/Trp ratio, and CD4 cell recovery', 'CD4 T-cell activation']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0022818', 'cui_str': 'Kynurenine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C2936411', 'cui_str': 'T Helper 17 Cells'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1308752', 'cui_str': 'CXCL10 protein, human'}, {'cui': 'C1173118', 'cui_str': 'FABP2 protein, human'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0039215', 'cui_str': 'T lymphocyte positive for CD4 antigen'}]",20.0,0.295739,"Plasma levels of triglycerides, total, and LDL cholesterol significantly decreased, following ER-niacin treatment.","[{'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lebouché', 'Affiliation': 'Chronic Viral Illness Service, Division of Infectious Disease, Department of Medicine, Glen Site, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Yero', 'Affiliation': 'Department of Biological Sciences and CERMO-FC Research Centre, University of Quebec at Montreal (UQAM), Montreal, QC, Canada.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Shi', 'Affiliation': 'Department of Biological Sciences and CERMO-FC Research Centre, University of Quebec at Montreal (UQAM), Montreal, QC, Canada.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Farnos', 'Affiliation': 'Department of Biological Sciences and CERMO-FC Research Centre, University of Quebec at Montreal (UQAM), Montreal, QC, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'CIHR Canadian HIV Trials Network, Vancouver, BC, Canada.'}, {'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'Kema', 'Affiliation': 'Department of Laboratory Medicine, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Cecilia T', 'Initials': 'CT', 'LastName': 'Costiniuk', 'Affiliation': 'Chronic Viral Illness Service, Division of Infectious Disease, Department of Medicine, Glen Site, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Réjean', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': ""Clinique médicale l'Actuel, Montreal, QC, Canada.""}, {'ForeName': 'Marie-Josée', 'Initials': 'MJ', 'LastName': 'Brouillette', 'Affiliation': 'Chronic Viral Illness Service, Division of Infectious Disease, Department of Medicine, Glen Site, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Engler', 'Affiliation': 'Center for Outcome Research Evaluation, Research Institute of the McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Routy', 'Affiliation': 'Chronic Viral Illness Service, Division of Infectious Disease, Department of Medicine, Glen Site, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Mohammad-Ali', 'Initials': 'MA', 'LastName': 'Jenabian', 'Affiliation': 'Department of Biological Sciences and CERMO-FC Research Centre, University of Quebec at Montreal (UQAM), Montreal, QC, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",HIV research & clinical practice,['10.1080/25787489.2020.1866846']
308,33444781,Dissemination of a telehealth cardiovascular risk service: The CVRS live protocol.,"BACKGROUND


Medical clinics are increasingly hiring clinical pharmacists to improve management of cardiovascular disease (CVD). However, the limited number of clinical pharmacists employed in a clinic may not impact the large number of complex patients needing the services. We have developed a remote telehealth service provided by clinical pharmacists to complement CVD services provided by on-site clinical pharmacists and aid sites without a clinical pharmacist. This cardiovascular risk service (CVRS) has been studied in two NIH-funded trials, however, we identified barriers to optimal intervention implementation. The purpose of this study is to examine how to implement the CVRS into medical offices and see if the intervention will be sustained.
METHODS


This is a 5-year, pragmatic, cluster-randomized clinical trial in 13 primary care clinics across the US. We randomized clinics to receive CVRS or usual care and will enroll 325 patient subjects and 288 key stakeholder subjects. We have obtained access to the electronic medical records (EMRs) of all study clinics to recruit subjects and provide the pharmacist intervention. The intervention is staggered so that after 12 months, the usual care sites will receive the intervention for 12 months. Follow-up will be accomplished though medical record abstraction at baseline, 12 months, 24 months, and 36 months.
CONCLUSIONS


This study will enroll subjects through 2021 and results will be available in 2024. This study will provide unique information on how the CVRS provided by remote clinical pharmacists can be effectively implemented in medical offices, many of which already employ on-site clinical pharmacists.
CLINICAL TRIAL REGISTRATION INFORMATION


NCT03660631: http://clinicaltrials.gov/ct2/show/NCT03660631.",2021,We have developed a remote telehealth service provided by clinical pharmacists to complement CVD services provided by on-site clinical pharmacists and aid sites without a clinical pharmacist.,"['13 primary care clinics across the US', 'enroll subjects through 2021 and results available in 2024', '300 patient subjects and 288 key stakeholder subjects']",['CVRS'],[],"[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],13.0,0.0746287,We have developed a remote telehealth service provided by clinical pharmacists to complement CVD services provided by on-site clinical pharmacists and aid sites without a clinical pharmacist.,"[{'ForeName': 'Korey A', 'Initials': 'KA', 'LastName': 'Kennelty', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, United States; Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, United States. Electronic address: korey-kennelty@uiowa.edu.'}, {'ForeName': 'Nels J', 'Initials': 'NJ', 'LastName': 'Engblom', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, United States.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Carter', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, United States; Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, United States.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Hollingworth', 'Affiliation': 'Department of Educational Policy and Leadership Studies, College of Education, University of Iowa, United States.'}, {'ForeName': 'Barcey T', 'Initials': 'BT', 'LastName': 'Levy', 'Affiliation': 'Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, United States; Department of Epidemiology, College of Public Health, University of Iowa, United States.'}, {'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Finkelstein', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, United States.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Parker', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, United States.'}, {'ForeName': 'Yinghui', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, United States.'}, {'ForeName': 'Kayla L', 'Initials': 'KL', 'LastName': 'Jackson', 'Affiliation': 'Department of Educational Policy and Leadership Studies, College of Education, University of Iowa, United States.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Dawson', 'Affiliation': 'Department of Biostatistics, College of Public Health, University of Iowa, United States.'}, {'ForeName': 'Kathryn K', 'Initials': 'KK', 'LastName': 'Dorsey', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106282']
309,33380248,"Methylprednisolone, dexamethasone or hydrocortisone for acute severe pediatric asthma: does it matter?","OBJECTIVE


Various intravenous (IV) corticosteroids are available for acute severe asthma (ASA) treatment. The choice of IV corticosteroids varies broadly and depends on institution, country, or physician preferences. In this study, we compared the efficacy of IV methylprednisolone, hydrocortisone and dexamethasone in ASA treatment during pediatric intensive care unit (PICU) admission.
METHODS


The study was a prospective randomized clinical trial. We enrolled patients of 1-21 years after they were admitted to the PICU requiring continuous beta-2 agonist treatment. Patients were randomized into three groups: Group A: IV Methylprednisolone, Group B: IV Hydrocortisone and Group C: IV Dexamethasone. The primary outcomes measured were durations of beta-2 agonist continuous nebulization treatment. Secondary outcomes, included PICU and hospital length of stay (LOS), pediatric asthma severity score (PASS), need for mechanical ventilation and maximum dose of beta-2 agonist treatment.
RESULTS


61 patients were included in the analysis. 22 patients recruited in Group A, 20 in group B and 19 group C. Median durations of beta-2-agonist treatment were 23 h (QR 16-38) for methylprednisolone, 27 h (QR 16-40) for hydrocortisone, and 32 h (QR 16-48) for dexamethasone ( p  = 0.90). There was no difference in PICU LOS, hospital LOS, PASS score, B2 agonist maximum dose, or need for ventilation support.
CONCLUSIONS


The use of IV methylprednisolone, hydrocortisone, and dexamethasone have equivalent efficacy when used at the appropriate doses. Studies with larger cohorts are needed to compare the effectiveness of IV corticosteroids in the management of ASA in the PICU setting.",2022,"There was no difference in PICU LOS, hospital LOS, PASS score, B2 agonist maximum dose, or need for ventilation support.  ","['61 patients were included in the analysis', 'Acute Severe Pediatric Asthma', 'acute severe asthma (ASA) treatment', 'ASA treatment during pediatric intensive care unit (PICU) admission', 'enrolled patients of 1-21\u2009years after they were admitted to the PICU requiring continuous beta-2 agonist treatment']","['Various intravenous (IV) corticosteroids', 'Methylprednisolone, Dexamethasone or Hydrocortisone', 'hydrocortisone', 'methylprednisolone, hydrocortisone, and dexamethasone', 'Hydrocortisone and Group C: IV Dexamethasone', 'Methylprednisolone', 'Methylprednisolone, hydrocortisone and dexamethasone', 'methylprednisolone', 'dexamethasone']","['PICU LOS, hospital LOS, PASS score, B2 agonist maximum dose, or need for ventilation support', 'durations of beta-2 agonist continuous nebulization treatment', 'PICU and hospital length of stay (LOS), pediatric asthma severity score (PASS), need for mechanical ventilation and maximum dose of beta-2 agonist treatment', 'Median durations of beta-2-agonist treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0038218', 'cui_str': 'Acute severe exacerbation of asthma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0581122', 'cui_str': 'Asthma severity'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",61.0,0.141599,"There was no difference in PICU LOS, hospital LOS, PASS score, B2 agonist maximum dose, or need for ventilation support.  ","[{'ForeName': 'Sule', 'Initials': 'S', 'LastName': 'Doymaz', 'Affiliation': 'Department of Pediatrics, Pediatric Critical Care Unit, SUNY Downstate Health Sciences University, Brooklyn, NY, USA.'}, {'ForeName': 'Youssef E', 'Initials': 'YE', 'LastName': 'Ahmed', 'Affiliation': 'Department of Pediatrics, Pediatric Critical Care Unit, SUNY Downstate Health Sciences University, Brooklyn, NY, USA.'}, {'ForeName': 'Densley', 'Initials': 'D', 'LastName': 'Francois', 'Affiliation': ""Department of Pediatrics, Neonatal Intensive Care Unit, Presbyterian Hospital/Morgan Stanley Children's Hospital, New York, NY, USA.""}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': 'Department of Pediatrics, Pediatric Critical Care Unit, SUNY Downstate Health Sciences University, Brooklyn, NY, USA.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Gist', 'Affiliation': 'Department of Pediatrics, Pediatric Critical Care Unit, SUNY Downstate Health Sciences University, Brooklyn, NY, USA.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Steinberg', 'Affiliation': 'Department of Pediatrics, Pediatric Critical Care Unit, SUNY Downstate Health Sciences University, Brooklyn, NY, USA.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Giambruno', 'Affiliation': 'Department of Pediatrics, Pediatric Critical Care Unit, SUNY Downstate Health Sciences University, Brooklyn, NY, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1870130']
310,33386953,Comparative Effect of Zoledronate at 6 Versus 18 Months Following Denosumab Discontinuation.,"Discontinuation of denosumab treatment is associated with rapid bone loss that could be prevented in many patients by zoledronate (ZOL) infusion given 6 months after the last denosumab injection. The effects, however, of zoledronate administration at a later time point are unknown. We aimed to compare the 1-year effect of ZOL infusion given 6 versus 18 months following the last Dmab injection. In this extension of a previously reported 2-year randomized clinical trial, we included initially treatment-naive postmenopausal women, who became osteopenic after approximately 2.5 years of denosumab therapy, and were subjected to a single ZOL infusion at 6 months (early-ZOL, n = 27) versus 18 months (late-ZOL, n = 15) after the last Dmab injection. Annual changes in lumbar spine (LS) and femoral neck (FN) bone mineral density (BMD), and markers of bone turnover (P1NP, CTx) at 6 and 12 months following ZOL infusion were assessed. LS BMD was maintained in both early-ZOL (+ 1.7%) and late-ZOL (+ 1.8%) infusion with no difference between groups (p = 0.949). FN BMD was maintained in early-ZOL (+ 0.1%) and increased in late-ZOL (+ 3.4%) infusion with no difference between groups (p = 0.182). Compared to 6 months after last Dmab injection, the overall LS BMD change of the late-ZOL group (- 3.5%) was significantly different (p = 0.007) from that of the early-ZOL group (+ 1.7%). P1NP and CTx gradually increased in the early-ZOL group, while profoundly decreased and remained suppressed in the late-ZOL infusion. A ZOL infusion 18 months following the last Dmab injection is still useful in terms of BMD maintenance and BTM suppression. However, there is no clear clinical benefit compared to the early infusion, while any theoretical advantage is counterbalanced from the expected bone loss, especially at the LS, and the risk of rebound-associated fractures.Trial Registration: NCT02499237; July 16, 2015.",2021,LS BMD was maintained in both early-ZOL (+ 1.7%) and late-ZOL (+ 1.8%) infusion with no difference between groups (p = 0.949).,"['initially treatment-naive postmenopausal women, who became osteopenic after approximately 2.5 years of']","['denosumab therapy', 'zoledronate', 'Zoledronate', 'denosumab', 'ZOL']","['FN BMD', 'LS BMD', 'BMD maintenance and BTM suppression', 'late-ZOL', 'P1NP and CTx', 'overall LS BMD change', 'lumbar spine (LS) and femoral neck (FN) bone mineral density (BMD), and markers of bone turnover (P1NP, CTx']","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3839270', 'cui_str': 'Denosumab therapy'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",,0.0359383,LS BMD was maintained in both early-ZOL (+ 1.7%) and late-ZOL (+ 1.8%) infusion with no difference between groups (p = 0.949).,"[{'ForeName': 'Athanasios D', 'Initials': 'AD', 'LastName': 'Anastasilakis', 'Affiliation': 'Department of Endocrinology, 424 General Military Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Stergios A', 'Initials': 'SA', 'LastName': 'Polyzos', 'Affiliation': 'First Laboratory of Pharmacology, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Maria P', 'Initials': 'MP', 'LastName': 'Yavropoulou', 'Affiliation': '1st Department of Propaedeutic Internal Medicine, Endocrinology Unit, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Natasha M', 'Initials': 'NM', 'LastName': 'Appelman-Dijkstra', 'Affiliation': 'Department of Internal Medicine, Center for Bone Quality, Section Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Charikleia', 'Initials': 'C', 'LastName': 'Ntenti', 'Affiliation': 'First Laboratory of Pharmacology, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Stylianos', 'Initials': 'S', 'LastName': 'Mandanas', 'Affiliation': 'Department of Endocrinology, 424 General Military Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Papatheodorou', 'Affiliation': 'Department of Endocrinology and Diabetes and Department of Medical Research, 251 Hellenic Air Force & VA General Hospital, 3 Kanellopoulou str, 115 25, Goudi, Athens, Greece.'}, {'ForeName': 'Polyzois', 'Initials': 'P', 'LastName': 'Makras', 'Affiliation': 'Department of Endocrinology and Diabetes and Department of Medical Research, 251 Hellenic Air Force & VA General Hospital, 3 Kanellopoulou str, 115 25, Goudi, Athens, Greece. pmakras@gmail.com.'}]",Calcified tissue international,['10.1007/s00223-020-00785-1']
311,33483868,Impact of 0.1% octenidine mouthwash on plaque re-growth in healthy adults: a multi-center phase 3 randomized clinical trial.,"OBJECTIVES


To investigate plaque inhibition of 0.1% octenidine mouthwash (OCT) vs. placebo over 5 days in the absence of mechanical plaque control.
MATERIALS AND METHODS


For this randomized, placebo-controlled, double-blind, parallel group, multi-center phase 3 study, 201 healthy adults were recruited. After baseline recording of plaque index (PI) and gingival index (GI), collection of salivary samples, and dental prophylaxis, subjects were randomly assigned to OCT or placebo mouthwash in a 3:1 ratio. Rinsing was performed twice daily for 30 s. Colony forming units in saliva were determined before and after the first rinse. At day 5, PI, GI, and tooth discoloration index (DI) were assessed. Non-parametric van Elteren tests were applied with a significance level of p < 0.05.
RESULTS


Treatment with OCT inhibited plaque formation more than treatment with placebo (PI: 0.36 vs. 1.29; p < 0.0001). OCT reduced GI (0.04 vs. placebo 0.00; p = 0.003) and salivary bacterial counts (2.73 vs. placebo 0.24 lgCFU/ml; p < 0.0001). Tooth discoloration was slightly higher under OCT (DI: 0.25 vs. placebo 0.00; p = 0.0011). Mild tongue staining and dysgeusia occurred.
CONCLUSIONS


OCT 0.1% mouthwash inhibits plaque formation over 5 days. It therefore can be recommended when regular oral hygiene is temporarily compromised.
CLINICAL RELEVANCE


When individual plaque control is compromised, rinsing with octenidine mouthwash is recommended to maintain healthy oral conditions while side effects are limited.",2021,"RESULTS


Treatment with OCT inhibited plaque formation more than treatment with placebo (PI: 0.36 vs. 1.29; p < 0.0001).","['201 healthy adults were recruited', 'healthy adults']","['octenidine mouthwash (OCT) vs. placebo', 'octenidine mouthwash', 'placebo', 'OCT or placebo']","['plaque re-growth', 'salivary bacterial counts', 'PI, GI, and tooth discoloration index (DI', 'OCT reduced GI', 'Mild tongue staining and dysgeusia', 'plaque index (PI) and gingival index (GI), collection of salivary samples, and dental prophylaxis', 'Tooth discoloration', 'plaque formation']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0069351', 'cui_str': 'octenidine'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0040434', 'cui_str': 'Staining of tooth'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0069351', 'cui_str': 'octenidine'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011393', 'cui_str': 'Prophylaxis, Dental'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",201.0,0.607834,"RESULTS


Treatment with OCT inhibited plaque formation more than treatment with placebo (PI: 0.36 vs. 1.29; p < 0.0001).","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Jockel-Schneider', 'Affiliation': 'Department of Periodontology, University Hospital Wuerzburg, Pleicherwall 2, 97070, Wuerzburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schlagenhauf', 'Affiliation': 'Department of Periodontology, University Hospital Wuerzburg, Pleicherwall 2, 97070, Wuerzburg, Germany.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Petsos', 'Affiliation': 'Department of Periodontology, Johann Wolfgang Goethe-Universität Frankfurt am Main, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Rüttermann', 'Affiliation': 'Department of Conservative Dentistry, Johann Wolfgang Goethe-Universität Frankfurt am Main, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cariology, Endodontology and Periodontology, University of Leipzig, Liebigstraße 12, 04103, Leipzig, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Ziebolz', 'Affiliation': 'Department of Cariology, Endodontology and Periodontology, University of Leipzig, Liebigstraße 12, 04103, Leipzig, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wehner', 'Affiliation': 'Division of Conservative Dentistry and Periodontology, Medical University of Vienna, Sensengasse 2a, 1090, Wien, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Laky', 'Affiliation': 'Division of Conservative Dentistry and Periodontology, Medical University of Vienna, Sensengasse 2a, 1090, Wien, Austria.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Rott', 'Affiliation': 'Department of Operative Dentistry and Periodontology, University of Cologne, Kerpener Str. 32, 50931, Köln, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Noack', 'Affiliation': 'Department of Operative Dentistry and Periodontology, University of Cologne, Kerpener Str. 32, 50931, Köln, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Noack', 'Affiliation': 'Department of Periodontology, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Lorenz', 'Affiliation': 'Department of Periodontology, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany. katrin.lorenz@tu-dresden.de.'}]",Clinical oral investigations,['10.1007/s00784-021-03781-3']
312,33484279,"Patient-Reported Outcomes from a Randomized, Active-Controlled, Open-Label, Phase 3 Trial of Burosumab Versus Conventional Therapy in Children with X-Linked Hypophosphatemia.","Changing to burosumab, a monoclonal antibody targeting fibroblast growth factor 23, significantly improved phosphorus homeostasis, rickets, lower-extremity deformities, mobility, and growth versus continuing oral phosphate and active vitamin D (conventional therapy) in a randomized, open-label, phase 3 trial involving children aged 1-12 years with X-linked hypophosphatemia. Patients were randomized (1:1) to subcutaneous burosumab or to continue conventional therapy. We present patient-reported outcomes (PROs) from this trial for children aged ≥ 5 years at screening (n = 35), using a Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire and SF-10 Health Survey for Children. PROMIS pain interference, physical function mobility, and fatigue scores improved from baseline with burosumab at weeks 40 and 64, but changed little with continued conventional therapy. Pain interference scores differed significantly between groups at week 40 (- 5.02, 95% CI - 9.29 to - 0.75; p = 0.0212) but not at week 64. Between-group differences were not significant at either week for physical function mobility or fatigue. Reductions in PROMIS pain interference and fatigue scores from baseline were clinically meaningful with burosumab at weeks 40 and 64 but not with conventional therapy. SF-10 physical health scores (PHS-10) improved significantly with burosumab at week 40 (least-squares mean [standard error] + 5.98 [1.79]; p = 0.0008) and week 64 (+ 5.93 [1.88]; p = 0.0016) but not with conventional therapy (between-treatment differences were nonsignificant). In conclusion, changing to burosumab improved PRO measures, with statistically significant differences in PROMIS pain interference at week 40 versus continuing with conventional therapy and in PHS-10 at weeks 40 and 64 versus baseline.Trial registration: ClinicalTrials.gov NCT02915705.",2021,Reductions in PROMIS pain interference and fatigue scores from baseline were clinically meaningful with burosumab at weeks 40 and 64 but not with conventional therapy.,"['children aged 1-12\xa0years with X-linked hypophosphatemia', 'Children with X-Linked Hypophosphatemia', 'children aged\u2009≥']","['Burosumab Versus Conventional Therapy', 'oral phosphate and active vitamin D (conventional therapy', 'subcutaneous burosumab or to continue conventional therapy']","['SF-10 physical health scores (PHS-10', 'PROMIS pain interference, physical function mobility, and fatigue scores', 'physical function mobility or fatigue', 'PROMIS pain interference', 'PROMIS pain interference and fatigue scores', 'Pain interference scores', 'phosphorus homeostasis, rickets, lower-extremity deformities, mobility, and growth', 'Outcomes Measurement Information System (PROMIS) questionnaire and SF-10 Health Survey for Children', 'PRO measures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0733682', 'cui_str': 'Hypophosphatemic Rickets, X-Linked Dominant'}]","[{'cui': 'C4301607', 'cui_str': 'burosumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0035579', 'cui_str': 'Rickets'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0936787,Reductions in PROMIS pain interference and fatigue scores from baseline were clinically meaningful with burosumab at weeks 40 and 64 but not with conventional therapy.,"[{'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Padidela', 'Affiliation': ""Department of Paediatric Endocrinology, Royal Manchester Children's Hospital, Manchester, UK. Raja.Padidela@mft.nhs.uk.""}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Whyte', 'Affiliation': 'Shriners Hospitals for Children -Washington University School of Medicine in St Louis, St Louis, MO, USA.'}, {'ForeName': 'Francis H', 'Initials': 'FH', 'LastName': 'Glorieux', 'Affiliation': 'Shriners Hospital for Children - Canada, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Craig F', 'Initials': 'CF', 'LastName': 'Munns', 'Affiliation': ""The University of Sydney Children's Hospital Westmead Clinical School, The Children's Hospital at Westmead, Westmead, NSW, Australia.""}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Ward', 'Affiliation': 'Department of Pediatrics, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Nilsson', 'Affiliation': 'Division of Pediatric Endocrinology & Center for Molecular Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Portale', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Departments of Pediatrics, Division of Endocrinology and Diabetes, Vanderbilt University School of Medicine, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Namba', 'Affiliation': 'Department of Pediatrics, Osaka Hospital, Japan Community Healthcare Organization, Osaka, Japan.'}, {'ForeName': 'Hae Il', 'Initials': 'HI', 'LastName': 'Cheong', 'Affiliation': ""Seoul National University Children's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Pisit', 'Initials': 'P', 'LastName': 'Pitukcheewanont', 'Affiliation': ""Center of Endocrinology, Diabetes and Metabolism, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Sochett', 'Affiliation': 'Department of Paediatrics, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Högler', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Johannes Kepler University Linz, Linz, Austria.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Muroya', 'Affiliation': ""Department of Endocrinology and Metabolism, Kanagawa Children's Medical Center, Yokohama, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Okayama Saiseikai General Hospital Outpatient Center, Okayama, Japan.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Gottesman', 'Affiliation': 'Shriners Hospitals for Children, St Louis, MO, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Biggin', 'Affiliation': ""The University of Sydney Children's Hospital Westmead Clinical School, The Children's Hospital at Westmead, Westmead, NSW, Australia.""}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Perwad', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Kyowa Kirin International, Marlow, UK.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Nixon', 'Affiliation': 'Chilli Consultancy, Salisbury, UK.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Kyowa Kirin Pharmaceutical Development, Princeton, NJ, USA.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Ultragenyx Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Skrinar', 'Affiliation': 'Ultragenyx Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Imel', 'Affiliation': 'Department of Medicine and Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.'}]",Calcified tissue international,['10.1007/s00223-020-00797-x']
313,33482395,Family automated voice reorientation (FAVoR) intervention for mechanically ventilated patients in the intensive care unit: Study protocol for a randomized controlled trial.,"Delirium in the intensive care unit (ICU) affects up to 80% of critically ill, mechanically ventilated (MV) adults. Delirium is associated with substantial negative outcomes, including increased hospital complications and long-term effects on cognition and health status in ICU survivors. The purpose of this randomized controlled trial is to test the effectiveness of a Family Automated Voice Reorientation (FAVoR) intervention on delirium among critically ill MV patients. The FAVoR intervention uses scripted audio messages, which are recorded by the patient's family and played at hourly intervals during daytime hours. This ongoing orientation to the ICU environment through recorded messages in a voice familiar to the patient may enable the patient to more accurately interpret the environment and thus reduce risk of delirium. The study's primary aim is to test the effect of the FAVoR intervention on delirium in critically ill MV adults in the ICU. The secondary aims are to explore: (1) if the effect of FAVoR on delirium is mediated by sleep, (2) if selected biobehavioral factors moderate the effects of FAVoR on delirium, and (3) the effects of FAVoR on short-term and long-term outcomes, including cognition and health status. Subjects (n = 178) are randomly assigned to the intervention or control group within 48 h of initial ICU admission and intubation. The intervention group receives FAVoR over a 5-day period, while the control group receives usual care. Delirium-free days, sleep and activity, cognition, patient-reported health status and sleep quality, and data regarding iatrogenic/environmental and biobehavioral factors are collected.",2021,"Delirium is associated with substantial negative outcomes, including increased hospital complications and long-term effects on cognition and health status in ICU survivors.","['critically ill MV patients', 'Subjects (n\u202f=\u202f178', 'critically ill MV adults in the ICU', 'mechanically ventilated patients in the intensive care unit', 'critically ill, mechanically ventilated (MV) adults']","['intervention or control group within 48\u202fh of initial ICU admission and intubation', 'FAVoR', 'Family automated voice reorientation (FAVoR) intervention', 'Family Automated Voice Reorientation (FAVoR) intervention', 'FAVoR intervention']","['Delirium-free days, sleep and activity, cognition, patient-reported health status and sleep quality, and data regarding iatrogenic/environmental and biobehavioral factors', 'hospital complications']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0878788,"Delirium is associated with substantial negative outcomes, including increased hospital complications and long-term effects on cognition and health status in ICU survivors.","[{'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Munro', 'Affiliation': 'University of Miami School of Nursing and Health Studies, 5030 Brunson Drive, Coral Gables, FL, United States. Electronic address: cmunro@miami.edu.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'University of Miami School of Nursing and Health Studies, 5030 Brunson Drive, Coral Gables, FL, United States.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Ji', 'Affiliation': 'University of South Florida College of Nursing, 12901 Bruce B. Downs Blvd, Tampa, FL, United States.'}, {'ForeName': 'Maya N', 'Initials': 'MN', 'LastName': 'Elías', 'Affiliation': 'University of Miami School of Nursing and Health Studies, 5030 Brunson Drive, Coral Gables, FL, United States.'}, {'ForeName': 'Xusheng', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'University of Miami School of Nursing and Health Studies, 5030 Brunson Drive, Coral Gables, FL, United States.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Calero', 'Affiliation': 'Department of Pulmonary, Critical Care, and Sleep Medicine, University of South Florida College of Medicine, 12901 Bruce B. Downs Blvd, Tampa, FL, United States.'}, {'ForeName': 'E Wesley', 'Initials': 'EW', 'LastName': 'Ely', 'Affiliation': ""Center for Critical Illness, Brain Dysfunction, and Survivorship (CIBS), Vanderbilt University Medical Center, 2525 West End Avenue Suite 450, Nashville, TN, United States; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, 1161 21st Ave S, Nashville, TN, United States; Veteran's Affairs TN Valley, Geriatrics Research, Education and Clinical Center (GRECC), 1310 24th Ave S, Nashville, TN, United States.""}]",Contemporary clinical trials,['10.1016/j.cct.2021.106277']
314,33485090,Introduction of a smartphone based behavioral intervention for migraine in the emergency department.,"OBJECTIVE


To determine whether a smartphone application (app) with an electronic headache diary and a progressive muscle relaxation (PMR) intervention is feasible and acceptable to people presenting to the Emergency Department (ED) with migraine.
METHODS


This single arm prospective study assessed feasibility by actual use of the app and acceptability by satisfaction with the app. We report preliminary data on change in migraine disability and headache days.
RESULTS


The 51 participants completed PMR sessions on a mean of 13 ± 19 (0,82) days for the 90-day study period, lasting a median of 11 min (IQR 6.5, 17) each. Median number of days of diary use was 34 (IQR 10, 77). Diaries were completed at least twice a week in half of study weeks (337/663). Participants were likely (≥4/5 on a 5-point Likert scale) to recommend both the app (85%) and PMR (91%). MIDAS scores significantly decreased by a mean of 38 points/participant (p < 0.0001). More frequent PMR use was associated with a higher odds of headache free days (p = 0.0148).
CONCLUSION


Smartphone-based PMR introduced to patients who present to the ED for migraine is feasible and acceptable. More frequent users have more headache free days. Future work should focus on intervention engagement.",2021,"More frequent PMR use was associated with a higher odds of headache free days (p = 0.0148).
",['people presenting to the Emergency Department (ED) with migraine'],"['smartphone based behavioral intervention', 'smartphone application (app) with an electronic headache diary and a progressive muscle relaxation (PMR) intervention', 'Smartphone-based PMR']","['Median number of days of diary use', 'migraine disability and headache days', 'MIDAS scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1309950', 'cui_str': 'GOLPH3 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0432556,"More frequent PMR use was associated with a higher odds of headache free days (p = 0.0148).
","[{'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'Department of Neurology, NYU Langone Health, 550 1st Avenue, New York, NY 10016, United States of America; Department of Population Health, NYU Langone Health, 180 Madison Ave, New York, NY 10016, United States of America. Electronic address: Minenmd@gmail.com.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Friedman', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, 1300 Morris Park Ave, The Bronx, NY 10461, United States of America.'}, {'ForeName': 'Samrachana', 'Initials': 'S', 'LastName': 'Adhikari', 'Affiliation': 'Department of Population Health, NYU Langone Health, 180 Madison Ave, New York, NY 10016, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Corner', 'Affiliation': 'Department of Neurology, NYU Langone Health, 550 1st Avenue, New York, NY 10016, United States of America.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Powers', 'Affiliation': ""Division of Behavioral Medicine & Clinical Psychology, Cincinnati Children's Hospital; Headache Center, Cincinnati Children's Hospital, 3333 Burnet Ave, Cincinnati, OH 45229, United States of America.""}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Seng', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University; Saul R. Korey Department of Neurology, Albert Einstein College of Medicine, 1165 Morris Park Ave, The Bronx, NY 10461, United States of America.'}, {'ForeName': 'Corita', 'Initials': 'C', 'LastName': 'Grudzen', 'Affiliation': 'Department of Population Health, NYU Langone Health, 180 Madison Ave, New York, NY 10016, United States of America; Department of Emergency Medicine, NYU Langone Health, 550 1st Avenue, New York, NY 10016, United States of America.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Montefiore Headache Center; Departments of Neurology, Population Health, and Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, 250 Waters Pl #8, The Bronx, NY 10461, United States of America.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.12.009']
315,33482135,"Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial.","OBJECTIVE


To validate the efficacy and safety of Ningmitai capsule (NMT) in the patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).
METHODS


We conducted a multicenter, randomized, double-blind, placebo-controlled trial in 120 men with CP/CPPS to evaluate the efficacy and safety of NMT. Participants were randomly assigned (1:1) to NMT or placebo treatment for 4 weeks at 3 centres. The patients were evaluated by the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) at baseline, the end of 2 and 4 weeks of treatment. The primary endpoints were the changes of the NIH-CPSI pain scores from baseline to the end of 2 and 4 weeks of the treatment. The secondary endpoints include the changes of the NIH-CPSI total scores, urinary symptoms scores and the quality of life (QoL) as well as the responder rate.
RESULTS


After 2 and 4 weeks of treatment, the mean decreases of the NIH-CPSI pain scores, total scores and QoL in the NMT group were all significantly superior to those in the placebo group. The responder rate was significantly higher in the NMT group than that in the placebo group at both 2 and 4 weeks. No adverse events were reported during the treatment.
CONCLUSION


NMT could significantly improve the pain symptoms and QoL in the patients with CP/CPPS as early as in 2 weeks, and the efficacy enhanced at the end of the 4-week treatment. The safety of NMT was confirmed in this trial.",2021,The responder rate was significantly higher in the NMT group than that in the placebo group at both 2 and 4 weeks.,"['Chronic Pelvic Pain Syndrome', '120 men with CP/CPPS', 'Patients with Chronic Prostatitis', 'patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS']","['placebo', 'NMT', 'Ningmitai Capsule', 'Ningmitai capsule (NMT', 'NMT or placebo', 'Placebo']","['pain symptoms and QoL', 'NIH-CPSI pain scores, total scores and QoL', 'changes of the NIH-CPSI total scores, urinary symptoms scores and the quality of life (QoL) as well as the responder rate', 'Health Chronic Prostatitis Symptom Index (NIH-CPSI', 'efficacy and safety of NMT', 'responder rate', 'adverse events', 'changes of the NIH-CPSI pain scores', 'Efficacy and Safety']","[{'cui': 'C1536168', 'cui_str': 'Chronic pelvic pain syndrome'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.216992,The responder rate was significantly higher in the NMT group than that in the placebo group at both 2 and 4 weeks.,"[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yuexin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""Department of Urology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jiaji', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jianlin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Guangyin', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Bai', 'Affiliation': ""Department of Urology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Beijing Tongren Hospital, Capital Medical University, Beijing, China. Electronic address: shanchentr001@163.com.'}]",Urology,['10.1016/j.urology.2021.01.018']
316,33484897,Targeting of uncontrolled hypertension in the emergency department (TOUCHED): Design of a randomized controlled trial.,"BACKGROUND


Uncontrolled or undiagnosed hypertension (HTN) is estimated to be as high as 46% in emergency departments (EDs). Uncontrolled HTN contributes significantly to cardiovascular morbidity and disproportionately affects communities of color. EDs serve high risk populations with uncontrolled conditions that are often missed by other clinical settings and effective interventions for uncontrolled HTN in the ED are critically needed. The ED is well situated to decrease the disparities in HTN control by providing a streamlined intervention to high risk populations that may use the ED as their primary care.
METHODS


Targeting of UnControlled Hypertension in the Emergency Department (TOUCHED), is a two-arm single site randomized controlled trial of 770 adults aged 18-75 presenting to the ED with uncontrolled HTN comparing (1) usual care, versus (2) an Educational and Empowerment (E2) intervention that integrates a Post-Acute Care Hypertension Consultation (PACHT-c) with a mobile health BP self-monitoring kit. The primary outcome is differences in mean systolic blood pressure (SBP) at 6-months post enrollment. Secondary outcomes include differences in mean SBP and mean diastolic BP (DBP) at 3-months and mean DBP at 6-months. Additionally, improvement in cardiovascular risk score, medication adherence, primary care engagement, and HTN knowledge will also be assessed as part of this study.
CONCLUSIONS


The TOUCHED trial will be instrumental in determining the effectiveness of a brief ED-based intervention that is portable to other urban EDs with high-risk populations.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT03749499.",2021,"The TOUCHED trial will be instrumental in determining the effectiveness of a brief ED-based intervention that is portable to other urban EDs with high-risk populations.
","['770 adults aged 18-75 presenting to the ED with uncontrolled HTN comparing (1) usual care, versus (2) an', 'urban EDs with high-risk populations']",['Educational and Empowerment (E2) intervention that integrates a Post-Acute Care Hypertension Consultation (PACHT-c) with a mobile health BP self-monitoring kit'],"['cardiovascular morbidity', 'mean SBP and mean diastolic BP (DBP) at 3-months and mean DBP', 'mean systolic blood pressure (SBP', 'cardiovascular risk score, medication adherence, primary care engagement, and HTN knowledge']","[{'cui': 'C4517873', 'cui_str': '770'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376635', 'cui_str': 'Postacute Care'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}]","[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",770.0,0.202538,"The TOUCHED trial will be instrumental in determining the effectiveness of a brief ED-based intervention that is portable to other urban EDs with high-risk populations.
","[{'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Prendergast', 'Affiliation': 'Department of Emergency Medicine, University of Illinois, Chicago, IL, USA. Electronic address: hprender@uic.edu.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Petzel-Gimbar', 'Affiliation': 'Department of Emergency Medicine and College of Pharmacy, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Kitsiou', 'Affiliation': 'Biomedical and Health Information Sciences, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Del Rios', 'Affiliation': 'Department of Emergency Medicine, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Lara', 'Affiliation': 'Department of Emergency Medicine, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Jackson', 'Affiliation': 'Department of Emergency Medicine, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Heinert', 'Affiliation': 'Department of Emergency Medicine, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Carter', 'Affiliation': 'College of Pharmacy, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Ramon A', 'Initials': 'RA', 'LastName': 'Durazo-Arvizu', 'Affiliation': 'Department of Public Health Sciences, Loyola University Chicago, Maywood, IL, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Daviglus', 'Affiliation': 'Institute for Minority Health Research, University of Illinois, Chicago, IL, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106283']
317,33482440,Per- and polyfluoroalkyl substances and kidney function: Follow-up results from the Diabetes Prevention Program trial.,"Per- and polyfluoroalkyl substances (PFAS) are ubiquitously detected in populations worldwide and may hinder kidney function. The objective of the study was to determine longitudinal associations of plasma PFAS concentrations with estimated glomerular filtration rate (eGFR) and evaluate whether a lifestyle intervention modify the associations. We studied 875 participants initially randomized to the lifestyle or placebo arms in the Diabetes Prevention Program (DPP, 1996-2002) trial and Outcomes Study (DPPOS, 2002-2014). We ran generalized linear mixed models accounting a priori covariates to evaluate the associations between baseline PFAS concentrations and repeated measures of eGFR, separately, for six PFAS (PFOS, PFOA, PFHxS, EtFOSAA, MeFOSAA, PFNA); then used quantile-based g-computation to evaluate the effects of the six PFAS chemicals as a mixture. The cohort was 64.9% female; 73.4% 40-64 years-old; 29.4% with hypertension; 50.5% randomized to lifestyle intervention and 49.5% to placebo and had similar plasma PFAS concentrations as the general U.S. population in 1999-2000. Most participants had normal kidney function (eGFR > 90 mL/min/1.73 m 2 ) over the approximately 14 years of follow-up. We found that plasma PFAS concentrations during DPP were inversely associated with eGFR during DPPOS follow-up. Each quartile increase in baseline plasma concentration of the 6 PFAS as a mixture was associated with 2.26 mL/min/1.73 m 2  lower eGFR (95% CI: -4.12, -0.39) at DPPOS Year 5, approximately 9 years since DPP randomization and PFAS measurements. The lifestyle intervention did not modify associations, but inverse associations were stronger among participants with hypertension at baseline. Among prediabetic adults, we found inverse associations between baseline plasma PFAS concentrations and measures of eGFR throughout 14 years of follow-up. The lifestyle intervention of diet, exercise and behavioral changes did not modify the associations, but persons with hypertension may have heightened susceptibility.",2021,"2  lower eGFR (95% CI: -4.12, -0.39) at DPPOS Year 5, approximately 9 years since DPP randomization and PFAS measurements.","['The cohort was 64.9% female; 73.4% 40-64\xa0years-old; 29.4% with hypertension', '875 participants initially randomized to the lifestyle or', 'participants with hypertension at baseline']","['Per- and polyfluoroalkyl substances (PFAS', 'lifestyle intervention', 'placebo']","['plasma PFAS concentrations', 'baseline plasma PFAS concentrations and measures of eGFR', 'baseline plasma concentration', 'normal kidney function']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517897', 'cui_str': '875'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",875.0,0.083112,"2  lower eGFR (95% CI: -4.12, -0.39) at DPPOS Year 5, approximately 9 years since DPP randomization and PFAS measurements.","[{'ForeName': 'Pi-I D', 'Initials': 'PD', 'LastName': 'Lin', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA. Electronic address: p_lin@harvardpilgrim.org.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Cardenas', 'Affiliation': 'Division of Environmental Health Sciences, School of Public Health, University of California, Berkeley, Berkeley, CA, USA. Electronic address: andres.cardenas@berkeley.edu.'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Hauser', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA. Electronic address: rhauser@hsph.harvard.edu.'}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Gold', 'Affiliation': ""Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA. Electronic address: redrg@channing.harvard.edu.""}, {'ForeName': 'Ken P', 'Initials': 'KP', 'LastName': 'Kleinman', 'Affiliation': 'Department of Biostatistics, School of Public Health and Human Sciences, University of Massachusetts Amherst, Amherst, MA, USA.'}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Hivert', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA; Diabetes Unit, Massachusetts General Hospital, Boston, MA, USA. Electronic address: mhivert@partners.org.'}, {'ForeName': 'Antonia M', 'Initials': 'AM', 'LastName': 'Calafat', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: aic7@cdc.gov.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Webster', 'Affiliation': 'Department of Environmental Health, Boston University School of Public Health, Boston, MA, USA. Electronic address: twebster@bu.edu.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA. Electronic address: edward.horton@joslin.harvard.edu.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Oken', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA. Electronic address: emily_oken@harvardpilgrim.org.'}]",Environment international,['10.1016/j.envint.2020.106375']
318,33423188,Effects of Bushen Yiqi Huoxue Decoction in Treatment of Patients with Diminished Ovarian Reserve: A Randomized Controlled Trial.,"OBJECTIVE


To explore the therapeutic effect of Bushen Yiqi Huoxue Decoction BYHD) in patients with diminished ovarian reserve (DOR).
METHODS


A total of 180 patients with DOR diagnosed from December 2013 to December 2014 were equally assigned into progynova and duphaston (E+D) group, Zuogui Pill group and BYHD group with 60 cases in each by computerized randomization. Patients received E+D, Zuogui Pill or BYHD for 12 months, respectively. Follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E 2 ), anti-Müllerian hormone (AMH), antral follicle count (AFC), ovarian volume, endometrial thickness, and the resistance indices (RIs) of ovarian arteries and uterine arteries were observed before and after treatment.
RESULTS


Nine women (4 from the E+D group, 3 from the Zuogui Pill group, and 2 from the BYHD group) withdrew from the study. After 6 months, Zuogui Pill and BYHD significantly decreased FSH and LH and increased endometrial thickness and AMH (all P<0.01). BYHD also resulted in E 2  elevation (P<0.05), ovary enlargement (P<0.05), AFC increase (P<0.01), and RI of ovarian arteries decrease (P<0.05). After 12 months, further improvements were observed in the Zuogui Pill and BYHD groups (all P<0.01), but BYHD showed better outcomes, with lower FSH, larger ovaries and a thicker endometrium compared with the Zuogui Pill group (all P<0.01). However, E+D only significantly increased endometrial thickness (P<0.01) and no significant improvements were observed in the RI of uterine arteries in the three groups.
CONCLUSIONS


BYHD had a favorable therapeutic effect in patients with DOR by rebalancing hormone levels, promoting ovulation, and repairing the thin endometrium. The combination of tonifying Shen (Kidney), benefiting qi and activating blood circulation may be a promising therapeutic strategy for DOR.",2022,"However, E+D only significantly increased endometrial thickness (P<0.01) and no significant improvements were observed in the RI of uterine arteries in the three groups.
","['patients with diminished ovarian reserve (DOR', '180 patients with DOR diagnosed from December 2013 to December 2014', 'Patients with Diminished Ovarian Reserve', 'Nine women (4 from the E+D group, 3 from the Zuogui Pill group, and 2 from the BYHD group) withdrew from the study']","['progynova and duphaston (E+D) group, Zuogui Pill () group and BYHD group with 60 cases in each by computerized randomization', 'tonifying Shen (Kidney', 'Bushen Yiqi Huoxue Decoction ( BYHD', 'E+D, Zuogui Pill or BYHD', 'Bushen Yiqi Huoxue Decoction ']","['FSH and LH and increased endometrial thickness and AMH', 'ovary enlargement (P<0.05), AFC increase (P<0.01), and RI of ovarian arteries decrease', 'lower FSH, larger ovaries and a thicker endometrium', 'endometrial thickness', 'Follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E 2 ), anti-Müllerian hormone (AMH), antral follicle count (AFC), ovarian volume, endometrial thickness, and the resistance indices (RIs) of ovarian arteries and uterine arteries', 'RI of uterine arteries']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0728806', 'cui_str': 'Progynova'}, {'cui': 'C0591419', 'cui_str': 'Duphaston'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2974451', 'cui_str': 'zuogui'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0728806', 'cui_str': 'Progynova'}, {'cui': 'C0591419', 'cui_str': 'Duphaston'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2974451', 'cui_str': 'zuogui'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0078696', 'cui_str': 'yiki-huoxue'}]","[{'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C0392039', 'cui_str': 'Large ovary'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0226411', 'cui_str': 'Structure of ovarian artery'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}]",180.0,0.050548,"However, E+D only significantly increased endometrial thickness (P<0.01) and no significant improvements were observed in the RI of uterine arteries in the three groups.
","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Laboratory for Reproductive Immunology, Hospital & Institute of Obstetrics and Gynecology, Shanghai Medical College, Fudan University, Shanghai, 200000, China.'}, {'ForeName': 'Xin-Yao', 'Initials': 'XY', 'LastName': 'Pan', 'Affiliation': 'Laboratory for Reproductive Immunology, Hospital & Institute of Obstetrics and Gynecology, Shanghai Medical College, Fudan University, Shanghai, 200000, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Laboratory for Reproductive Immunology, Hospital & Institute of Obstetrics and Gynecology, Shanghai Medical College, Fudan University, Shanghai, 200000, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Yangpu Hospital of Traditional Chinese Medicine, Shanghai, 200000, China.'}, {'ForeName': 'Li-Kun', 'Initials': 'LK', 'LastName': 'Lan', 'Affiliation': 'Second Affiliated Hospital of Hexi University, Zhangye, Gansu Province, 743000, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ""Department of Obstetrics and Gynecology, Wenling People's Hospital, Wenzhou Medical University, Wenzhou, Zhejiang Province, 325000, China.""}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Duan', 'Affiliation': 'Regulatory Commission Office of the New Cooperative Medical Scheme, Eryuan County, Dali, Yunnan Province, 671000, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Laboratory for Reproductive Immunology, Hospital & Institute of Obstetrics and Gynecology, Shanghai Medical College, Fudan University, Shanghai, 200000, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Laboratory for Reproductive Immunology, Hospital & Institute of Obstetrics and Gynecology, Shanghai Medical College, Fudan University, Shanghai, 200000, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Laboratory for Reproductive Immunology, Hospital & Institute of Obstetrics and Gynecology, Shanghai Medical College, Fudan University, Shanghai, 200000, China. dr.wangling@fudan.edu.cn.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3484-x']
319,33492394,Dietary sodium intake does not alter renal potassium handling and blood pressure in healthy young males.,"BACKGROUND


The effects of sodium (Na+) intakes on renal handling of potassium (K+) are insufficiently studied.
METHODS


We assessed the effect of Na+ on renal K+ handling in 16 healthy males assigned to three 7-day periods on low salt diet [LSD, 3 g sodium chloride (NaCl)/day], normal salt diet (NSD, 6 g NaCl/day) and high salt diet (HSD, 15 g NaCl/day), with constant K+ intake. Contributions of distal NaCl co-transporter and epithelial Na+ channel in the collecting system on K+ and Na+ handling were assessed at steady state by acute response to 100 mg oral hydrochlorothiazide and with addition of 10 mg of amiloride to hydrochlorothiazide, respectively.
RESULTS


Diurnal blood pressure slightly increased from 119.30 ± 7.95 mmHg under LSD to 123.00 ± 7.50 mmHg (P = 0.02) under HSD, while estimated glomerular filtration rate increased from 133.20 ± 34.68 mL/min under LSD to 187.00 ± 49.10 under HSD (P = 0.005). The 24-h K+ excretion remained stable on all Na+ intakes (66.28 ± 19.12 mmol/24 h under LSD; 55.91 ± 21.17 mmol/24 h under NSD; and 66.81 ± 20.72 under HSD, P = 0.9). The hydrochlorothiazide-induced natriuresis was the highest under HSD (30.22 ± 12.53 mmol/h) and the lowest under LSD (15.38 ± 8.94 mmol/h, P = 0.02). Hydrochlorothiazide increased kaliuresis and amiloride decreased kaliuresis similarly on all three diets.
CONCLUSIONS


Neither spontaneous nor diuretic-induced K+ excretion was influenced by Na+ intake in healthy male subjects. However, the respective contribution of the distal convoluted tubule and the collecting duct to renal Na+ handling was dependent on dietary Na+ intake.",2022,"Twenty-four hours potassium excretion remained stable on all sodium intakes (66.28 ± 19.12 mmol/24h under LSD; 55.91 ± 21.17 mmol/24h under NSD and 66.81 ± 20.72 under HSD, P = 0.9).","['healthy male subjects', '16 healthy males', 'healthy young males']","['distal NaCl co-transporter and epithelial sodium channel', 'Dietary sodium intake', 'amiloride to hydrochlorothiazide', 'sodium intakes', 'hydrochlorothiazide', 'low (LSD, 3\u2009g NaCl/d), normal (NSD, 6\u2009g NaCl/d) and high (HSD, 15\u2009g NaCl/d) sodium diet with constant potassium intake', 'sodium', 'Hydrochlorothiazide']","['glomerular filtration rate', 'kaliuresis and amiloride decreased kaliuresis', 'renal potassium handling and blood pressure', 'spontaneous nor diuretic-induced potassium excretion', 'natriuresis', 'Diurnal blood pressure']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0384156', 'cui_str': 'Epithelial Sodium Channel'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0002502', 'cui_str': 'Amiloride'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C2930923', 'cui_str': 'N-Acetylneuraminic acid storage disease'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1837657', 'cui_str': 'CHST3-related skeletal dysplasia'}, {'cui': 'C0301592', 'cui_str': 'Sodium diet'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0920110', 'cui_str': 'Kaluresis'}, {'cui': 'C0002502', 'cui_str': 'Amiloride'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0027477', 'cui_str': 'Natriuresis'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}]",16.0,0.0303821,"Twenty-four hours potassium excretion remained stable on all sodium intakes (66.28 ± 19.12 mmol/24h under LSD; 55.91 ± 21.17 mmol/24h under NSD and 66.81 ± 20.72 under HSD, P = 0.9).","[{'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Pechère-Bertschi', 'Affiliation': 'Service of Nephrology and Hypertension, University Hospital Geneva, Geneva, Switzerland.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Olivier', 'Affiliation': 'Service of Nephrology and Hypertension, University Hospital Geneva, Geneva, Switzerland.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Burnier', 'Affiliation': 'Service of Nephrology and Hypertension, CHUV, Lausanne, Switzerland.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Udwan', 'Affiliation': 'Department of Cell Physiology and Metabolism, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'de Seigneux', 'Affiliation': 'Service of Nephrology and Hypertension, University Hospital Geneva, Geneva, Switzerland.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Ponte', 'Affiliation': 'Service of Nephrology and Hypertension, University Hospital Geneva, Geneva, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Maillard', 'Affiliation': 'Service of Nephrology and Hypertension, CHUV, Lausanne, Switzerland.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Martin', 'Affiliation': 'Service of Nephrology and Hypertension, University Hospital Geneva, Geneva, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Feraille', 'Affiliation': 'Service of Nephrology and Hypertension, University Hospital Geneva, Geneva, Switzerland.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa381']
320,33487528,"Brief interventions to prevent excessive alcohol use in adolescents at low-risk presenting to Emergency Departments: Three-arm, randomised trial of effectiveness and cost-effectiveness.","BACKGROUND


Alcohol consumption and related harm increase rapidly from the age of 12 years. We evaluated whether alcohol screening and brief intervention is effective and cost-effective in delaying hazardous or harmful drinking amongst low-risk or abstaining adolescents attending Emergency Departments (EDs).
METHODS


This ten-centre, three-arm, parallel-group, single-blind, pragmatic, individually randomised trial screened ED attenders aged between 14 and 17 years for alcohol consumption. We sampled at random one third of those scoring at most 2 on AUDIT-C who had access to the internet and, if aged under 16, were Gillick competent or had informed consent from parent or guardian. We randomised them between: screening only (control intervention); one session of face-to-face Personalised Feedback and Brief Advice (PFBA); and PFBA plus an electronic brief intervention (eBI) on smartphone or web. We conducted follow-up after six and 12 months. The principal outcomes were alcohol consumed over the 3 months before 12-month follow up, measured by AUDIT-C; and quality-adjusted life-years.
FINDINGS


Between October 2014 and May 2015, we approached 5,016 eligible patients of whom 3,326 consented to be screened and participate in the trial; 2,571 of these were low-risk drinkers or abstainers, consuming an average 0.14 units per week. We randomised: 304 to screening only; 285 to PFBA; and 294 to PFBA and eBI. We found no significant difference between groups, notably in weekly alcohol consumption: those receiving screening only drank 0.10 units (95% confidence interval 0.05 to 0.18); PFBA 0.12 (0.06 to 0.21); PFBA and eBI 0.10 (0.05 to 0.19).
INTERPRETATION


While drinking levels remained low in this population, this trial found no evidence that PFBA with or without eBI was more effective than screening alone in reducing or delaying alcohol consumption.",2021,"We found no significant difference between groups, notably in weekly alcohol consumption: those receiving screening only drank 0.10 units (95% confidence interval 0.05 to 0.18); PFBA 0.12 (0.06 to 0.21); PFBA and eBI 0.10 (0.05 to 0.19).
","['random one third of those scoring at most 2 on AUDIT-C who had access to the internet and, if aged under 16, were Gillick competent or had informed consent from parent or guardian', 'adolescents attending Emergency Departments (EDs', 'adolescents at low-risk presenting to Emergency Departments', 'ED attenders aged between 14 and 17 years for alcohol consumption', '5,016 eligible patients of whom 3,326 consented to be screened and participate in the trial; 2,571 of these were low-risk drinkers or abstainers, consuming an average 0.14 units per week']","['screening only (control intervention); one session of face-to-face Personalised Feedback and Brief Advice (PFBA); and PFBA plus an electronic brief intervention (eBI) on smartphone or web', 'alcohol screening and brief intervention']",['reducing or delaying alcohol consumption'],"[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C4517430', 'cui_str': '0.14'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",5016.0,0.0966228,"We found no significant difference between groups, notably in weekly alcohol consumption: those receiving screening only drank 0.10 units (95% confidence interval 0.05 to 0.18); PFBA 0.12 (0.06 to 0.21); PFBA and eBI 0.10 (0.05 to 0.19).
","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Deluca', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London UK. Electronic address: paolo.deluca@kcl.ac.uk.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Coulton', 'Affiliation': 'Centre for Health Services Studies, University of Kent, Canterbury, UK.'}, {'ForeName': 'Mohammed Fasihul', 'Initials': 'MF', 'LastName': 'Alam', 'Affiliation': 'College of Health Sciences, QU Health, Qatar University, Doha, Qatar.'}, {'ForeName': 'Sadie', 'Initials': 'S', 'LastName': 'Boniface', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Health Economics and Policy Research Unit, University of South Wales, Pontypridd, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Donoghue', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London UK.""}, {'ForeName': 'Eilish', 'Initials': 'E', 'LastName': 'Gilvarry', 'Affiliation': 'Northumberland Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Maconochie', 'Affiliation': 'Paediatric Emergency Medicine, Imperial College, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McArdle', 'Affiliation': 'Northumberland Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McGovern', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Newbury-Birch', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Patton', 'Affiliation': 'School of Psychology, University of Surrey, Guildford, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Pellatt-Higgins', 'Affiliation': 'Centre for Health Services Studies, University of Kent, Canterbury, UK.'}, {'ForeName': 'Ceri', 'Initials': 'C', 'LastName': 'Phillips', 'Affiliation': 'Swansea Centre for Health Economics, College of Human and Health Sciences, Swansea University, Swansea, Wales, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Phillips', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London UK; Institute for Clinical and Applied Health Research, University of Hull, Hull, UK.""}, {'ForeName': 'Rhys D', 'Initials': 'RD', 'LastName': 'Pockett', 'Affiliation': 'Swansea Centre for Health Economics, College of Human and Health Sciences, Swansea University, Swansea, Wales, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Russell', 'Affiliation': 'Medical School, Swansea University, Swansea, Wales, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London UK.""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Drummond', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London UK.""}]",The International journal on drug policy,['10.1016/j.drugpo.2021.103113']
321,33492500,Efficacy of oral steroid gel in preventing esophageal stricture after extensive endoscopic submucosal dissection: a randomized controlled trial.,"BACKGROUND AND AIMS


Esophageal stricture is a distressing issue for patients with early esophageal cancer following extensive endoscopic submucosal dissection (ESD), and the current steroid-based approaches are unsatisfactory for stricture prophylaxis. We evaluated the efficacy of oral hydrocortisone sodium succinate and aluminum phosphate gel (OHA) for stricture prophylaxis after extensive ESD.
METHODS


Patients undergoing > 3/4 circumferential ESD were randomized to either the endoscopic loco-regional triamcinolone acetonide injection (ETI) plus oral prednisone group or the OHA group. The primary endpoint was incidence of esophageal stricture, and the secondary endpoints included adverse events (AEs) and endoscopic balloon dilations (EBDs).
RESULTS


The incidence of esophageal stricture in OHA group (per-protocol analysis, 9.4%, 3/32; intention-to-treat analysis, 12.1%, 4/33) was significantly less than that of control group (per-protocol analysis, 35.5%, 11/31, P = 0.013; intention-to-treat analysis, 39.4%, 13/33, P = 0.011). Two sessions of EBD were necessary to release all strictures in the OHA group, while the similar EBDs (median 2, range 1-4) for 11 of the control. Operation-related AEs included infection (control vs. OHA group = 9.7% vs. 31.3%, P = 0.034), operation-related hypokalemia (19.4% vs. 31.3%, P = 0.278), perforation (3.2% vs. 3.1%), post-ESD hemorrhage (6.5% vs. 0%), and cardiac arrhythmia (0% vs. 6.3%). Steroid-related AEs included steroid-related hypokalemia (16.1% vs. 25%) and bone fracture (3.2% vs. 0%). Multivariate logistic regression analysis demonstrated that OHA was an independent protective factor for stricture (OR 0.079; 95%CI 0.011, 0.544; P = 0.01) and mucosal defect > 11/12 circumference was an independent risk factor (OR 49.91; 95%CI 6.7, 371.83; P < 0.001).
CONCLUSIONS


OHA showed significantly better efficacy in preventing esophageal stricture after > 3/4 circumferential ESD compared to ETI plus oral prednisone.",2022,"11/12 circumference was an independent risk factor (OR 49.91; 95%CI 6.7, 371.83; P < 0.001).
","['Patients undergoing\u2009>\u20093/4 circumferential ESD', 'patients with early esophageal cancer following extensive endoscopic submucosal dissection (ESD', 'esophageal stricture after extensive endoscopic submucosal dissection']","['oral steroid gel', 'ETI plus oral prednisone', 'oral hydrocortisone sodium succinate and aluminum phosphate gel (OHA', 'endoscopic loco-regional triamcinolone acetonide injection (ETI) plus oral prednisone group or the OHA group']","['perforation', 'esophageal stricture', 'operation-related hypokalemia', 'adverse events (AEs) and endoscopic balloon dilations (EBDs', 'steroid-related hypokalemia', 'cardiac arrhythmia', 'post-ESD hemorrhage', 'bone fracture', 'incidence of esophageal stricture']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C4551650', 'cui_str': 'Stricture of esophagus'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0360554', 'cui_str': 'Hydrocortisone-containing product in oral dose form'}, {'cui': 'C0142928', 'cui_str': 'Sodium succinate'}, {'cui': 'C0051519', 'cui_str': 'aluminum phosphate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C4551650', 'cui_str': 'Stricture of esophagus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.118453,"11/12 circumference was an independent risk factor (OR 49.91; 95%CI 6.7, 371.83; P < 0.001).
","[{'ForeName': 'Yiyang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Department of Gastroenterology, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, China.'}, {'ForeName': 'Xiue', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'The Department of Gastroenterology, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, China.'}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'The Department of Gastroenterology, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, China. 13911765322@163.com.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Nie', 'Affiliation': 'The Department of Gastroenterology, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, China.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The Department of Gastroenterology, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'The Department of Gastroenterology, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, China.'}, {'ForeName': 'Yaopeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Department of Gastroenterology, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yao', 'Affiliation': 'The Department of Gastroenterology, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'The Department of Gastroenterology, Peking University Third Hospital, 49 North Garden Rd., Haidian District, Beijing, China.'}]",Surgical endoscopy,['10.1007/s00464-021-08296-2']
322,33356051,A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19.,"BACKGROUND


LY-CoV555, a neutralizing monoclonal antibody, has been associated with a decrease in viral load and the frequency of hospitalizations or emergency department visits among outpatients with coronavirus disease 2019 (Covid-19). Data are needed on the effect of this antibody in patients who are hospitalized with Covid-19.
METHODS


In this platform trial of therapeutic agents, we randomly assigned hospitalized patients who had Covid-19 without end-organ failure in a 1:1 ratio to receive either LY-CoV555 or matching placebo. In addition, all the patients received high-quality supportive care as background therapy, including the antiviral drug remdesivir and, when indicated, supplemental oxygen and glucocorticoids. LY-CoV555 (at a dose of 7000 mg) or placebo was administered as a single intravenous infusion over a 1-hour period. The primary outcome was a sustained recovery during a 90-day period, as assessed in a time-to-event analysis. An interim futility assessment was performed on the basis of a seven-category ordinal scale for pulmonary function on day 5.
RESULTS


On October 26, 2020, the data and safety monitoring board recommended stopping enrollment for futility after 314 patients (163 in the LY-CoV555 group and 151 in the placebo group) had undergone randomization and infusion. The median interval since the onset of symptoms was 7 days (interquartile range, 5 to 9). At day 5, a total of 81 patients (50%) in the LY-CoV555 group and 81 (54%) in the placebo group were in one of the two most favorable categories of the pulmonary outcome. Across the seven categories, the odds ratio of being in a more favorable category in the LY-CoV555 group than in the placebo group was 0.85 (95% confidence interval [CI], 0.56 to 1.29; P = 0.45). The percentage of patients with the primary safety outcome (a composite of death, serious adverse events, or clinical grade 3 or 4 adverse events through day 5) was similar in the LY-CoV555 group and the placebo group (19% and 14%, respectively; odds ratio, 1.56; 95% CI, 0.78 to 3.10; P = 0.20). The rate ratio for a sustained recovery was 1.06 (95% CI, 0.77 to 1.47).
CONCLUSIONS


Monoclonal antibody LY-CoV555, when coadministered with remdesivir, did not demonstrate efficacy among hospitalized patients who had Covid-19 without end-organ failure. (Funded by Operation Warp Speed and others; TICO ClinicalTrials.gov number, NCT04501978.).",2021,"The rate ratio for a sustained recovery was 1.06 (95% CI, 0.77 to 1.47).
","['patients who are hospitalized with Covid-19', 'hospitalized patients who had Covid-19 without end-organ failure', 'Hospitalized Patients with Covid-19', '314 patients (163 in the LY-CoV555 group and 151 in the placebo group) had undergone randomization and infusion', 'randomly assigned hospitalized patients who had Covid-19 without end-organ failure in a 1:1 ratio to receive either', 'outpatients with coronavirus disease 2019 (Covid-19']","['placebo', 'LY-CoV555 or matching placebo']","['median interval since the onset of symptoms', 'rate ratio for a sustained recovery', 'sustained recovery during a 90-day period, as assessed in a time-to-event analysis', 'composite of death, serious adverse events, or clinical grade 3 or 4 adverse events through day 5']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",81.0,0.528095,"The rate ratio for a sustained recovery was 1.06 (95% CI, 0.77 to 1.47).
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Jens D', 'Initials': 'JD', 'LastName': 'Lundgren', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Grund', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Christina E', 'Initials': 'CE', 'LastName': 'Barkauskas', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Holland', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Uriel', 'Initials': 'U', 'LastName': 'Sandkovsky', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Brown', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Kirk U', 'Initials': 'KU', 'LastName': 'Knowlton', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'D Clark', 'Initials': 'DC', 'LastName': 'Files', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Mamta K', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Bowdish', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Bradley G', 'Initials': 'BG', 'LastName': 'Leshnower', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Jason V', 'Initials': 'JV', 'LastName': 'Baker', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Jens-Ulrik', 'Initials': 'JU', 'LastName': 'Jensen', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Gardner', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Estelle S', 'Initials': 'ES', 'LastName': 'Harris', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Isik S', 'Initials': 'IS', 'LastName': 'Johansen', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Markowitz', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Matthay', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Davey', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Goodman', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Higgs', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Murray', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Murray', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Paredes', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Mahesh K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Phillips', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Cavan', 'Initials': 'C', 'LastName': 'Reilly', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Dewar', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Teitelbaum', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Wentworth', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Huyen', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Abdel G', 'Initials': 'AG', 'LastName': 'Babiker', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Annetine C', 'Initials': 'AC', 'LastName': 'Gelijns', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Virginia L', 'Initials': 'VL', 'LastName': 'Kan', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Polizzotto', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'B Taylor', 'Initials': 'BT', 'LastName': 'Thompson', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': ""From the CHIP Center of Excellence for Health, Immunity, and Infections (J.D.L., D.D.M.), and the Department of Infectious Diseases (J.D.L., D.D.M., J.-U.J.), Rigshospitalet, Copenhagen, the Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre (T.B.), the Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup (J.-U.J.), the Department of Infectious Diseases, Odense University Hospital, Odense (I.S.J.), and the Department of Infectious Diseases, Aarhus University Hospital, Skejby (L.Ø.) - all in Denmark; the School of Statistics (B.G.) and the Division of Biostatistics, School of Public Health (T.A.M., C.R., S.S., D.W., J.D.N.), University of Minnesota, Hennepin Healthcare Research Institute (J.V.B.), and the University of Minnesota (J.V.B.), Minneapolis; the Divisions of Pulmonary, Allergy, and Critical Care Medicine (C.E.B.) and Infectious Disease (T.L.H.), Department of Medicine, Duke University, Durham, and the Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy, and Immunology, Wake Forest School of Medicine, Winston-Salem (D.C.F.) - both in North Carolina; the Center for Advanced Heart and Lung Disease (R.L.G.) and the Division of Infectious Diseases (U.S.), Baylor University Medical Center, and the Department of Internal Medicine, UT Southwestern Medical Center (M.K.J.), Dallas; the Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray (S.M.B.), and the Department of Internal Medicine, University of Utah (S.M.B., E.S.H.) and Intermountain Healthcare (K.U.K.), Salt Lake City - both in Utah; the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); the Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.), the Department of Medicine and Anesthesia and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco (M.A.M.), and Gilead Sciences, Foster City (H.C.) - all in California; the Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (B.G.L.); Denver Public Health, Denver Health and Hospital Authority, Denver (E.M.G.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.); the Department of Infectious Diseases, Henry Ford Hospital, Detroit (N.M.); the Kirby Institute, University of New South Wales (C.C.C., M.N.P.), and St. Vincent's Hospital (M.N.P.), Sydney; the Department of Veterans Affairs (V.J.D.), the Veterans Affairs Medical Center (V.L.K.), and George Washington University School of Medicine and Health Sciences (V.L.K.), Washington, DC; the Medical Research Council Clinical Trials Unit at UCL (A.G., A.G.B., M.K.B.P.), the Institute of Clinical Trials and Methodology (M.K.B.P.), and the Institute for Global Health (A.N.P.), University College London, and Guy's and St. Thomas' NHS Foundation Trust (A.G.), London; the National Institute of Allergy and Infectious Diseases, Bethesda (E.S.H., H.C.L.), and Leidos Biomedical Research, Frederick (R.L.D., M.T.) - both in Maryland; the Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (R.P.); Eli Lilly, Indianapolis (P.K.); the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York (A.C.G.); and the Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston (B.T.T.).""}]",The New England journal of medicine,['10.1056/NEJMoa2033130']
323,33486385,Reductions in social anxiety during treatment predict lower levels of loneliness during follow-up among individuals with social anxiety disorder.,"INTRODUCTION


Individuals with social anxiety disorder (SAD) are at elevated risk of loneliness, yet little research has examined loneliness in this population. Cognitive-behavioral group therapy (CBGT) and mindfulness-based stress reduction (MBSR) have demonstrated efficacy in treating SAD, yet research has not examined whether they lead to reductions in loneliness.
METHODS


This sample comprised 108 individuals with SAD who were randomized to CBGT, MBSR, or a waitlist control (WL); WL participants were re-randomized to CBGT or MBSR following WL. Assessments were completed pre- and post-treatment, and 3-, 6-, 9-, and 12-month follow-up assessments.
RESULTS


Compared to WL, individuals in CBGT and MBSR were less lonely at post-treatment; there was no difference between treatments after treatment or during follow-up. Greater reductions in social anxiety from pre- to post-treatment predicted lower levels of loneliness during follow-up. Greater reductions in loneliness from pre- to post-treatment also predicted lower levels of social anxiety during follow-up.
DISCUSSION


Individuals who experience reductions in their social anxiety during treatment may also feel less lonely following treatment. Reductions in loneliness also lead to improvements in social anxiety. Future research should continue to examine the relationship between social anxiety and loneliness and how interventions for SAD may help reduce loneliness.",2021,"Greater reductions in loneliness from pre- to post-treatment also predicted lower levels of social anxiety during follow-up.
","['Individuals with social anxiety disorder (SAD', '108 individuals with SAD who were randomized to CBGT, MBSR, or a waitlist control (WL); WL participants were re-randomized to', 'individuals with social anxiety disorder']","['CBGT or MBSR', 'Cognitive-behavioral group therapy (CBGT) and mindfulness-based stress reduction (MBSR']",['social anxiety'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}]",108.0,0.0170514,"Greater reductions in loneliness from pre- to post-treatment also predicted lower levels of social anxiety during follow-up.
","[{'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': ""O'Day"", 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Butler', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Amanda S', 'Initials': 'AS', 'LastName': 'Morrison', 'Affiliation': 'Department of Psychology, California State University, East Bay, Hayward, CA 94542, USA.'}, {'ForeName': 'Philippe R', 'Initials': 'PR', 'LastName': 'Goldin', 'Affiliation': 'UC Davis Medical Center, University of California, Davis, Davis, CA, 95616, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Gross', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Heimberg', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA, 19122, USA. Electronic address: heimberg@temple.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2021.102362']
324,33430695,Cerebrospinal Fluid Sulfonylurea Receptor-1 is Associated with Intracranial Pressure and Outcome after Pediatric TBI: An Exploratory Analysis of the Cool Kids Trial.,"Sulfonylurea receptor-1 (SUR1) is recognized increasingly as a key contributor to cerebral edema, hemorrhage progression, and possibly neuronal death in multiple forms of acute brain injury. SUR1 inhibition may be protective and is actively undergoing evaluation in Phase-2/3 trials of traumatic brain injury (TBI) and stroke. In adult TBI, SUR1 expression is associated with intracranial hypertension and contusion expansion; its role in pediatric TBI remains unexplored. We tested 61 cerebrospinal fluid (CSF) samples from 16 pediatric patients with severe TBI enrolled in the multicenter Phase-3 randomized controlled ""Cool Kids"" trial and seven non-brain injured pediatric controls for SUR1 expression by enzyme-linked immunosorbent assay. Linear mixed models evaluated associations between mean SUR1 and intracranial pressure (ICP) over the first seven days and pediatric Glasgow Outcome Scale-Extended (GOS-E Peds) over the initial year after injury. SUR1 was undetectable in control CSF and increased versus control in nine of 16 patients with TBI. Mean SUR1 was not associated with age, sex, or therapeutic hypothermia. Each 1-point increase in initial Glasgow Coma Score was associated with a 1.68 ng/mL decrease in CSF SUR1. The CSF SUR1 was associated with increased ICP over seven days (b = 0.73,  p  = 0.004) and worse (higher) GOS-E Peds score (b = 0.24,  p  = 0.004). In this exploratory pediatric study, CSF SUR1 was undetectable in controls and variably elevated in severe TBI. Mean CSF SUR1 concentration was associated with ICP and outcome. These findings are distinct from our previous report in adults with severe TBI, where SUR1 was detected universally. SUR1 may be a viable therapeutic target in a subset of pediatric TBI, and further study is warranted.",2021,"CSF Sur1 was associated increased ICP over 7 days ( = 0.73, p=0.004) and worse (higher) GOS-E Peds score ( = 0.24, p=0.004).","[""61 cerebrospinal fluid (CSF) samples from 16 pediatric severe TBI patients enrolled in the multicenter Phase-3 randomized controlled 'Cool Kids' trial and 7 non-brain injured pediatric controls for Sur1 expression by ELISA""]",['Sulfonylurea Receptor-1 (Sur1'],"['mean Sur1 and intracranial pressure (ICP', 'initial GCS', 'ICP', 'CSF Sur1', 'Mean CSF Sur1 concentration']","[{'cui': 'C1292530', 'cui_str': 'Cerebrospinal fluid sample'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}]","[{'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",61.0,0.0407513,"CSF Sur1 was associated increased ICP over 7 days ( = 0.73, p=0.004) and worse (higher) GOS-E Peds score ( = 0.24, p=0.004).","[{'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Zusman', 'Affiliation': 'Department of Neurosurgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Kochanek', 'Affiliation': 'Department of Clinical and Translational Science Institute, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bell', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'P David', 'Initials': 'PD', 'LastName': 'Adelson', 'Affiliation': ""Barrow Neurological Institute at Phoenix Children's Hospital, Phoenix, Arizona, USA.""}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'University of Pittsburgh Graduate School of Publich Health, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Alicia K', 'Initials': 'AK', 'LastName': 'Au', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert S B', 'Initials': 'RSB', 'LastName': 'Clark', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Bayır', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Keri', 'Initials': 'K', 'LastName': 'Janesko-Feldman', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Ruchira M', 'Initials': 'RM', 'LastName': 'Jha', 'Affiliation': 'Department of Neurosurgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}]",Journal of neurotrauma,['10.1089/neu.2020.7501']
325,33436276,Prostatic Urethral Lift Versus Medical Therapy: Examining the Impact on Sexual Function in Men with Benign Prostatic Hyperplasia.,"BACKGROUND


Sexual dysfunction is a common side effect of medical therapy for benign prostatic hyperplasia (BPH), whereas prostatic urethral lift (PUL) offers safe and effective relief of lower urinary tract symptoms while preserving sexual function.
OBJECTIVE


To compare the long-term impact on sexual health of PUL or daily medical therapy of doxazosin or finasteride alone or in combination in BPH patients.
DESIGN, SETTING, AND PARTICIPANTS


This was a comparative analysis of sexual function outcomes from PUL studies (L.I.F.T. [n=107], Crossover [n=42], and MedLift [n=39]) and the Medical Therapy of Prostatic Symptoms (MTOPS) trial. The men included were sexually active with International Prostate Symptom Score ≥13, Qmax ≤12ml/s, and prostate volume 30-80 cm 3 . MTOPS subjects completed the Brief Male Sexual Function Inventory, while PUL subjects completed the International Index of Erectile Function and the Male Sexual Health Questionnaire for Ejaculatory Function.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Mean percentage changes from baseline in erectile, ejaculatory, and sexual satisfaction domains were compared at 12, 24, 36, and 48 mo.
RESULTS AND LIMITATIONS


PUL significantly improved erectile function through 24 mo, and ejaculatory function and sexual satisfaction across all time points. Medical therapy did not improve sexual function at any time point. Finasteride significantly decreased erectile function at 48 mo, and combined therapy significantly reduced ejaculatory function at 12 and 24 mo. Comparatively, PUL was superior to finasteride in preserving erectile function at 24 and 48 mo, and superior to doxazosin and combined therapy at 12 mo. PUL outperformed all three medical therapies at all time points in improving ejaculatory function and sexual satisfaction. Limitations include the use of distinct patient-reported questionnaires and narrowed data on comorbidities that influence male sexual function.
CONCLUSIONS


Indirect comparison reveals that PUL is superior to BPH medical therapy in preserving erectile and ejaculatory function and sexual satisfaction.
PATIENT SUMMARY


In our non-head-to-head study, only patients undergoing PUL for an enlarged prostate experienced improvements in sexual health. Conversely, patients on medical therapy experienced worsening of erectile and ejaculatory function.",2022,"Finasteride significantly decreased erectile function at 48 mo, and combined therapy","['BPH patients', 'men included were sexually active with International Prostate Symptom Score ≥13, Qmax ≤12ml/s, and prostate volume 30-80 cm 3 ', 'benign prostatic hyperplasia (BPH', 'Men with Benign Prostatic Hyperplasia', 'PUL studies (L.I.F.T. [n=107], Crossover [n=42], and MedLift [n=39]) and the Medical Therapy of Prostatic Symptoms (MTOPS) trial']","['combined therapy', 'Finasteride', 'prostatic urethral lift (PUL', 'doxazosin or finasteride alone', 'Prostatic Urethral Lift Versus Medical Therapy', 'doxazosin', 'finasteride']","['sexual function', 'ejaculatory function and sexual satisfaction', 'ejaculatory function', 'sexual health', 'erectile, ejaculatory, and sexual satisfaction domains', 'worsening of erectile and ejaculatory function', 'International Index of Erectile Function and the Male Sexual Health Questionnaire for Ejaculatory Function', 'erectile function', 'Sexual Function']","[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0060389', 'cui_str': 'Finasteride'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0114873', 'cui_str': 'Doxazosin'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0231486,"Finasteride significantly decreased erectile function at 48 mo, and combined therapy","[{'ForeName': 'Claus G', 'Initials': 'CG', 'LastName': 'Roehrborn', 'Affiliation': 'UT Southwestern Medical Center, Dallas, TX, USA. Electronic address: claus.roehrborn@utsouthwestern.edu.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Rukstalis', 'Affiliation': 'Prisma Health USC Medical Group, Division of Urology; 300 Palmetto Health Pkwy, Columbia, SC 29212.'}]",European urology focus,['10.1016/j.euf.2020.12.013']
326,33444766,Impact of Pre-Existing Mitral Regurgitation Following Left Ventricular Assist Device Implant.,"OBJECTIVES


Optimal management of significant mitral regurgitation (SMR) during left ventricular assist device (LVAD) placement remains uncertain. This study evaluates the effect of untreated preop SMR on outcomes following LVAD implant.
METHODS


Adults undergoing primary LVAD placement from April 2004 to May 2017 were included. Most recent preop transthoracic echocardiogram (TTE) was used to divide patients into an SMR group with moderate or greater regurgitation, and a group without SMR. Patients underwent LVAD implant without correction of SMR. Primary endpoint was 3-year postoperative survival, with secondary endpoints of length of stay (LOS), resolution of SMR following LVAD on postdischarge (30 day) TTE, and 1-year TTE.
RESULTS


LVAD placement was performed in 270 patients, 172 (63.7%) without SMR and 98 (36.3%) with SMR. There were no differences in comorbidities including diabetes, hypertension, and renal disease. Preop ejection fraction was similar, but a higher pulmonary vascular resistance was recorded in the SMR group (3.6 vs 3.0 Wood Units, P = 0.048). There was no difference in 3-year mortality between the 2 cohorts (log-rank P = 0.0.803). The SMR group had decreased LOS (median 19.5 vs 22 days, P = 0.009). Of the 98 SMR patients, 91 (92.9%) had resolution of SMR to less than moderate at 30 days. At 1 year, 15% of those with preoperative SMR had recurrent SMR.
CONCLUSIONS


Patients undergoing LVAD placement with preop SMR experience no differences in mortality, and a majority experience resolution of MR after implant. Longer-term SMR recurrence and need for mitral intervention with LVAD implant warrant further investigation.",2021,"The SMR group had decreased LOS (median 19.5 vs 22 days, p=0.009).","['Patients undergoing LVAD placement with', 'Adults undergoing primary LVAD placement from April 2004 to May 2017 were included']","['pre-op transthoracic echocardiogram (TTE', 'untreated pre-op SMR', 'LVAD implant without correction of SMR', 'Pre-Existing Mitral Regurgitation Following Left Ventricular Assist Device Implant', 'left ventricular assist device (LVAD) placement']","['recurrent SMR', 'mortality', 'LOS', 'pulmonary vascular resistance', 'co-morbidities including diabetes, hypertension, and renal disease', 'resolution of SMR', '3-year post-operative survival, with secondary endpoints of length of stay (LOS), resolution of SMR following LVAD on post-discharge (30 day) TTE, and 1-year TTE', '3-year mortality', 'op ejection fraction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",270.0,0.19936,"The SMR group had decreased LOS (median 19.5 vs 22 days, p=0.009).","[{'ForeName': 'Garrett N', 'Initials': 'GN', 'LastName': 'Coyan', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Pierce', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Zachary J', 'Initials': 'ZJ', 'LastName': 'Rhinehart', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Ruppert', 'Affiliation': 'Epidemiology, School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Katz', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Kilic', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Kormos', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Sciortino', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address: sciortinocm@upmc.edu.'}]",Seminars in thoracic and cardiovascular surgery,['10.1053/j.semtcvs.2020.12.007']
327,33449799,"Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer.","PURPOSE


Immunotherapy has revolutionized the treatment of advanced non-small-cell lung cancer (NSCLC). In two phase III trials (CheckMate 017 and CheckMate 057), nivolumab showed an improvement in overall survival (OS) and favorable safety versus docetaxel in patients with previously treated, advanced squamous and nonsquamous NSCLC, respectively. We report 5-year pooled efficacy and safety from these trials.
METHODS


Patients (N = 854; CheckMate 017/057 pooled) with advanced NSCLC, ECOG PS ≤ 1, and progression during or after first-line platinum-based chemotherapy were randomly assigned 1:1 to nivolumab (3 mg/kg once every 2 weeks) or docetaxel (75 mg/m 2  once every 3 weeks) until progression or unacceptable toxicity. The primary end point for both trials was OS; secondary end points included progression-free survival (PFS) and safety. Exploratory landmark analyses were investigated.
RESULTS


After the minimum follow-up of 64.2 and 64.5 months for CheckMate 017 and 057, respectively, 50 nivolumab-treated patients and nine docetaxel-treated patients were alive. Five-year pooled OS rates were 13.4% versus 2.6%, respectively; 5-year PFS rates were 8.0% versus 0%, respectively. Nivolumab-treated patients without disease progression at 2 and 3 years had an 82.0% and 93.0% chance of survival, respectively, and a 59.6% and 78.3% chance of remaining progression-free at 5 years, respectively. Treatment-related adverse events (TRAEs) were reported in 8 of 31 (25.8%) nivolumab-treated patients between 3-5 years of follow-up, seven of whom experienced new events; one (3.2%) TRAE was grade 3, and there were no grade 4 TRAEs.
CONCLUSION


At 5 years, nivolumab continued to demonstrate a survival benefit versus docetaxel, exhibiting a five-fold increase in OS rate, with no new safety signals. These data represent the first report of 5-year outcomes from randomized phase III trials of a programmed death-1 inhibitor in previously treated, advanced NSCLC.",2021,"Treatment-related adverse events (TRAEs) were reported in 8 of 31 (25.8%) nivolumab-treated patients between 3-5 years of follow-up, seven of whom experienced new events; one (3.2%)","['patients with previously treated, advanced squamous and nonsquamous NSCLC, respectively', 'advanced non-small-cell lung cancer (NSCLC', 'Patients (N = 854; CheckMate 017/057 pooled) with advanced NSCLC, ECOG PS ≤ 1, and progression during or after first-line platinum-based chemotherapy']","['nivolumab', 'docetaxel', 'Nivolumab Versus Docetaxel']","['progression-free survival (PFS) and safety', 'OS rate', 'disease progression', '5-year PFS rates', 'OS rates', 'adverse events (TRAEs', 'survival benefit', 'overall survival (OS) and favorable safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.191519,"Treatment-related adverse events (TRAEs) were reported in 8 of 31 (25.8%) nivolumab-treated patients between 3-5 years of follow-up, seven of whom experienced new events; one (3.2%)","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Borghaei', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Gettinger', 'Affiliation': 'Yale Comprehensive Cancer Center, New Haven, CT.'}, {'ForeName': 'Everett E', 'Initials': 'EE', 'LastName': 'Vokes', 'Affiliation': 'Univeristy of Chicago Medicine and Biologic Sciences Division, Chicago, IL.'}, {'ForeName': 'Laura Q M', 'Initials': 'LQM', 'LastName': 'Chow', 'Affiliation': 'University of Washington, Seattle Cancer Care Alliance, Seattle, WA.'}, {'ForeName': 'Marco Angelo', 'Initials': 'MA', 'LastName': 'Burgio', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'de Castro Carpeno', 'Affiliation': 'Hospital De Madrid, Norte Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pluzanski', 'Affiliation': 'Maria Sklodowska-Curie Inst of Oncology, Warsaw, Poland.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Arrieta', 'Affiliation': 'Instituto Nacional De Cancerología, Mexico City, Mexico.'}, {'ForeName': 'Osvaldo Arén', 'Initials': 'OA', 'LastName': 'Frontera', 'Affiliation': 'Centro de Investigación Clínica Bradford Hill and Centro Internacional de Estudios Clinicos, Santiago, Chile.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Chiari', 'Affiliation': 'Ospedale S. Maria Della Misericordia, Perugia, Italy.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Butts', 'Affiliation': 'Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wójcik-Tomaszewska', 'Affiliation': 'Provincial Center of Oncology in Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Coudert', 'Affiliation': 'Centre Georges-François Leclerc, Dijon, France.'}, {'ForeName': 'Marina Chiara', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Instituto Nazionale per Lo Studio e La Cura, Milano, Italy.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Ready', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Miriam Alonso', 'Initials': 'MA', 'LastName': 'García', 'Affiliation': 'Hospital Universitario Virgen Del Rocio, Sevilla, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Waterhouse', 'Affiliation': 'Oncology Hematology Care, Inc, Cincinnati, OH.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Domine', 'Affiliation': 'Fundacion Jimenez Diaz, IIS-FJD Madrid, Spain.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Aix Marseille University, CNRS, INSERM, CRCM, APHM, Marseille, France.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Antonia', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Wohlleber', 'Affiliation': 'Robert Bosch Cancer Center, Gerlingen, Germany.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Czyzewicz', 'Affiliation': 'John Paul II Hospital, Kraków, Poland.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Crino', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Wilfried Enst Erich', 'Initials': 'WEE', 'LastName': 'Eberhardt', 'Affiliation': 'Universitaetsmedizin Essen und Ruhrlandklinik, Essen, Germany.'}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Sathiya', 'Initials': 'S', 'LastName': 'Marimuthu', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brahmer', 'Affiliation': 'Johns Hopkins Kimmel Cancer Center, Baltimore, MD.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01605']
328,33432880,Supporting auditory word recognition with transcranial direct current stimulation: effects in elderly individuals with and without objective memory complaints.,"Healthy elderly people often experience a subjective loss of daily memory performance whereas an objective decrease in memory performance is often observed in patients with memory complaints. In this paper, we investigate the influence of a single session of ""anodal"" transcranial direct current stimulation (a-tDCS) on auditory word recognition performance in a decision time experiment. Three groups of participants (>64 years of age) with and without memory complaints underwent a word recognition task, in which they had to recognize words previously encoded among several distractors (semantically or phonologically related words) via a button press. In this double-blinded study, the participants completed two sessions (sham/a-tDCS), counterbalanced between subjects with a washout period of at least 10 days. Twenty minutes of 1.5 mA a-tDCS was applied over the left temporal cortex during the memorizing and decision phases. Overall, our results demonstrated that the participants, independent of their memory performance, were faster in word recognition during a-tDCS. As expected, older participants with memory complaints recognized significantly less words correctly compared to other participants. However, tDCS did not have a beneficial effect on the extent of successful word recognition. These results suggest a general effect of a single session of a-tDCS over the left temporal cortex, with participants becoming faster in their word recognition, thus having easier access to encoded words.",2022,"However, tDCS did not have a beneficial effect on the extent of successful word recognition.","['older participants with memory complaints', 'elderly individuals with and without objective memory complaints', 'patients with memory complaints', 'Healthy elderly people', 'Three groups of participants (>64\xa0years of age) with and without memory complaints underwent a word recognition task, in which they had to recognize words previously encoded among several distractors (semantically or phonologically related words) via a button press']","['anodal"" transcranial direct current stimulation (a-tDCS', 'tDCS', 'transcranial direct current stimulation']","['auditory word recognition performance', 'word recognition', 'memory performance']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}]",,0.0837688,"However, tDCS did not have a beneficial effect on the extent of successful word recognition.","[{'ForeName': 'Larissa S', 'Initials': 'LS', 'LastName': 'Balduin-Philipps', 'Affiliation': 'Experimental Neurolinguistics Group, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Weiss', 'Affiliation': 'Experimental Neurolinguistics Group, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Mueller', 'Affiliation': 'Experimental Neurolinguistics Group, Bielefeld University, Bielefeld, Germany.'}]","Neuropsychology, development, and cognition. Section B, Aging, neuropsychology and cognition",['10.1080/13825585.2020.1861203']
329,33436401,"OGTT Glucose Response Curves, Insulin Sensitivity, and β-Cell Function in RISE: Comparison Between Youth and Adults at Randomization and in Response to Interventions to Preserve β-Cell Function.","OBJECTIVE


We examined the glucose response curves (biphasic [BPh], monophasic [MPh], incessant increase [IIn]) during an oral glucose tolerance test (OGTT) and their relationship to insulin sensitivity (IS) and β-cell function (βCF) in youth versus adults with impaired glucose tolerance or recently diagnosed type 2 diabetes.RESEARCH DESIGN AND METHODSThis was both a cross-sectional and a longitudinal evaluation of participants in the RISE study randomized to metformin alone for 12 months or glargine for 3 months followed by metformin for 9 months. At baseline/randomization, OGTTs (85 youth, 353 adults) were categorized as BPh, MPh, or IIn. The relationship of the glucose response curves to hyperglycemic clamp-measured IS and βCF at baseline and the change in glucose response curves 12 months after randomization were assessed.RESULTSAt randomization, the prevalence of the BPh curve was significantly higher in youth than adults (18.8% vs. 8.2%), with no differences in MPh or IIn. IS did not differ across glucose response curves in youth or adults. However, irrespective of curve type, youth had lower IS than adults ( P  < 0.05). βCF was lowest in IIn versus MPh and BPh in youth and adults ( P  < 0.05), yet compared with adults, youth had higher βCF in BPh and MPh ( P  < 0.005) but not IIn. At month 12, the change in glucose response curves did not differ between youth and adults, and there was no treatment effect.CONCLUSIONSDespite a twofold higher prevalence of the more favorable BPh curve in youth at randomization, RISE interventions did not result in beneficial changes in glucose response curves in youth compared with adults. Moreover, the typical β-cell hypersecretion in youth was not present in the IIn curve, emphasizing the severity of β-cell dysfunction in youth with this least favorable glucose response curve.",2021,"βCF was lowest in IIn versus MPh and BPh in youth and adults ( P  < 0.05), yet compared with adults, youth had higher βCF in BPh and MPh ( P  < 0.005) but not IIn.",['youth versus adults with impaired glucose tolerance or recently diagnosed type 2 diabetes'],"['metformin', 'glargine']","['OGTT Glucose Response Curves, Insulin Sensitivity, and β-Cell Function', 'glucose response curves', 'glucose response curves (biphasic [BPh], monophasic [MPh], incessant increase [IIn]) during an oral glucose tolerance test (OGTT) and their relationship to insulin sensitivity (IS) and β-cell function (βCF', 'βCF', 'prevalence of the BPh curve']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0205186', 'cui_str': 'Monophasic'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}]",353.0,0.0309929,"βCF was lowest in IIn versus MPh and BPh in youth and adults ( P  < 0.05), yet compared with adults, youth had higher βCF in BPh and MPh ( P  < 0.005) but not IIn.","[{'ForeName': 'Silva A', 'Initials': 'SA', 'LastName': 'Arslanian', 'Affiliation': ""University of Pittsburgh, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'El Ghormli', 'Affiliation': 'George Washington University Biostatistics Center (RISE Coordinating Center), Rockville, MD rise@bsc.gwu.edu.'}, {'ForeName': 'Joon Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Exercise Science, Syracuse University, Syracuse, NY.'}, {'ForeName': 'Ashley H', 'Initials': 'AH', 'LastName': 'Tjaden', 'Affiliation': 'George Washington University Biostatistics Center (RISE Coordinating Center), Rockville, MD.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barengolts', 'Affiliation': 'Jesse Brown VA Medical Center, Chicago, IL.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Caprio', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'Tamara S', 'Initials': 'TS', 'LastName': 'Hannon', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ""Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, Denver, CO.""}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'VA Puget Sound Health Care System and University of Washington, Seattle, WA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-2134']
330,33443695,Project ACTIVE: a Randomized Controlled Trial of Personalized and Patient-Centered Preventive Care in an Urban Safety-Net Setting.,"BACKGROUND


Evidence-based preventive care in the USA is underutilized, diminishing population health and worsening health disparities. We developed Project ACTIVE, a program to improve adherence with preventive care goals through personalized and patient-centered care.
OBJECTIVE


To determine whether Project ACTIVE improved utilization of preventive care and/or estimated life expectancy compared to usual care.
DESIGN


Single-site randomized controlled trial.
PARTICIPANTS


Cluster-randomized 140 English or Spanish speaking adult patients in primary care with at least one of twelve unfulfilled preventive care goals based on USPSTF grade A and B recommendations.
INTERVENTION


Project ACTIVE employs a validated mathematical model to predict and rank individualized estimates of health benefit that would arise from improved adherence to different preventive care guidelines. Clinical staff engaged the participant in a shared medical decision-making (SMD) process to identify highest priority unfulfilled clinical goals, and health coaching staff engaged the participant to develop and monitor action steps to reach those goals.
MAIN MEASURES


Change in number of unfulfilled preventive care goals from USPSTF grade A and B recommendations and change in overall gain in estimated life expectancy.
KEY RESULTS


In an intent-to-treat analysis, Project ACTIVE increased the average number of fulfilled preventive care goals out of 12 by 0.68 in the intervention arm compared with 0.15 in the control arm (mean difference [95% CI] 0.53 [0.19-0.86]), yielding a gain in estimated life expectancy of 8.8 months (3.8, 14.2). In a per-protocol analysis, Project ACTIVE increased fulfilled preventive care goals by 0.80 in the intervention arm compared with 0.16 in the control arm (mean difference [95% CI], 0.65 [0.25-1.04]), yielding a gain in estimated life expectancy of 13.7 months (6.2, 21.2). Among the 12 preventive care goals, more improvement occurred for alcohol use, hypertension, hyperlipidemia, depression, and smoking.
CONCLUSIONS


Project ACTIVE improved unfulfilled preventive care goals and improved estimated life expectancy.
CLINICAL TRIAL REGISTRATION NUMBER


NCT04211883.",2021,"Among the 12 preventive care goals, more improvement occurred for alcohol use, hypertension, hyperlipidemia, depression, and smoking.
",['Cluster-randomized 140 English or Spanish speaking adult patients in primary care with at least one of twelve unfulfilled preventive care goals based on USPSTF grade A and B recommendations'],['Personalized and Patient-Centered Preventive Care'],"['fulfilled preventive care goals', 'number of unfulfilled preventive care goals from USPSTF grade A and B recommendations and change in overall gain in estimated life expectancy', 'alcohol use, hypertension, hyperlipidemia, depression, and smoking']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4277527', 'cui_str': 'Preventative Care'}]","[{'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]",140.0,0.0983633,"Among the 12 preventive care goals, more improvement occurred for alcohol use, hypertension, hyperlipidemia, depression, and smoking.
","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Applegate', 'Affiliation': 'New York University Langone Health, 462 1st Avenue, Desk 2D, New York, NY, 10016, USA. Melanie.A.Applegate@gmail.com.'}, {'ForeName': 'Ebony', 'Initials': 'E', 'LastName': 'Scott', 'Affiliation': 'MDRC, New York, NY, USA.'}, {'ForeName': 'Glen B', 'Initials': 'GB', 'LastName': 'Taksler', 'Affiliation': 'Medicine Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Mirtala', 'Initials': 'M', 'LastName': 'Sanchez', 'Affiliation': 'New York University Langone Health, 462 1st Avenue, Desk 2D, New York, NY, 10016, USA.'}, {'ForeName': 'Nguyet', 'Initials': 'N', 'LastName': 'Duong', 'Affiliation': 'New York University Langone Health, 462 1st Avenue, Desk 2D, New York, NY, 10016, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Mark', 'Affiliation': 'Mount Sinai Health System, New York, NY, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Caniglia', 'Affiliation': 'New York University Langone Health, 462 1st Avenue, Desk 2D, New York, NY, 10016, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wallach', 'Affiliation': 'New York University Langone Health, 462 1st Avenue, Desk 2D, New York, NY, 10016, USA.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Braithwaite', 'Affiliation': 'New York University Langone Health, 462 1st Avenue, Desk 2D, New York, NY, 10016, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06359-z']
331,33452438,Beta-adrenergic blockade blunts inflammatory and antiviral/antibody gene expression responses to acute psychosocial stress.,"Dysregulation of the immune system is one potential mechanism by which acute stress may contribute to downstream disease etiology and psychopathology. Here, we tested the role of β-adrenergic signaling as a mediator of acute stress-induced changes in immune cell gene expression. In a randomized, double-blind, and placebo-controlled trial, 90 healthy young adults (44% female) received a single 40 mg dose of the β-blocker propranolol (n = 43) or a placebo (n = 47) and then completed the Trier Social Stress Test (TSST). Pre- and post-stress blood samples were assayed for prespecified sets of pro-inflammatory and antiviral/antibody gene transcripts. Analyses revealed increased expression of both inflammatory and antiviral/antibody-related genes in response to the TSST, and these effects were blocked by pre-treatment with propranolol. Bioinformatics identified natural killer cells and dendritic cells as the primary cellular context for transcriptional upregulation, and monocytes as the primary cellular carrier of genes downregulated by the TSST. These effects were in part explained by acute changes in circulating cell types. Results suggest that acute psychosocial stress can induce an ""acute defense"" molecular phenotype via β-adrenergic signaling that involves mobilization of natural killer cells and dendritic cells at the expense of monocytes. This may represent an adaptive response to the risk of acute injury. These findings offer some of the first evidence in humans that β-blockade attenuates psychosocial stress-induced increases in inflammatory gene expression, offering new insights into the molecular and immunologic pathways by which stress may confer risks to health and well-being.",2021,"Analyses revealed increased expression of both inflammatory and antiviral/antibody-related genes in response to the TSST, and these effects were blocked by pre-treatment with propranolol.",['90 healthy young adults (44% female'],"['propranolol', 'single 40\u2009mg dose of the β-blocker propranolol', 'placebo (n\u2009=\u200947) and then completed the Trier Social Stress Test (TSST', 'placebo']",['expression of both inflammatory and antiviral/antibody-related genes in response to the TSST'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]",90.0,0.140392,"Analyses revealed increased expression of both inflammatory and antiviral/antibody-related genes in response to the TSST, and these effects were blocked by pre-treatment with propranolol.","[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'MacCormack', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. maccormack@pitt.edu.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Gaudier-Diaz', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Armstrong-Carter', 'Affiliation': 'Graduate School of Education, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jesusa M G', 'Initials': 'JMG', 'LastName': 'Arevalo', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Meltzer-Brody', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Erica K', 'Initials': 'EK', 'LastName': 'Sloan', 'Affiliation': 'Monash Institute of Pharmaceutical Sciences, Drug Discovery Biology Theme, Monash University, Parkville, VIC, Australia.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Cole', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Keely A', 'Initials': 'KA', 'LastName': 'Muscatell', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00897-0']
332,33440262,Pump It Up! A randomized clinical trial to optimize insulin pump self-management behaviors in adolescents with type 1 diabetes.,"Individuals with type 1 diabetes (T1D) must engage in a variety of complex and burdensome self-management behaviors daily to maintain near normal blood glucose levels and prevent complications. There is a need for interventions to improve use of sophisticated diabetes technologies, such as insulin pumps, during adolescence - a very high-risk developmental period for individuals with T1D. All diabetes devices, including insulin pumps, store large amounts of behavioral data that can be downloaded and analyzed to evaluate adherence to recommended T1D self-management behaviors. The overall objective of the present study, Pump it Up!, was to use objectively downloaded insulin pump data to inform and test two interventions to optimize insulin pump use in adolescents with T1D and their caregivers. Multiphase Optimization Strategy (MOST) was used to achieve the overall goal of this study - to separately test the main effect of the Pump It Up! Personalized T1D Self-Management Behaviors Feedback Report and the main effect of Pump It Up! Problem-Solving Skills intervention to improve T1D self-management behaviors using a 2 × 2 factorial design. The purpose of this paper is to describe the Pump It Up! study design and rationale, and participant baseline characteristics. Longitudinal data analyses will be conducted, and moderating effects of psychosocial factors will be examined in relation to primary (insulin pump self-management behaviors) and secondary (A1C) outcomes.",2021,"There is a need for interventions to improve use of sophisticated diabetes technologies, such as insulin pumps, during adolescence - a very high-risk developmental period for individuals with T1D. All diabetes devices, including insulin pumps, store large amounts of behavioral data that can be downloaded and analyzed to evaluate adherence to recommended T1D self-management behaviors.","['Individuals with type 1 diabetes (T1D', 'adolescents with type 1 diabetes', 'adolescents with T1D and their caregivers']","['Problem-Solving intervention', 'Pump', 'insulin pump self-management behaviors', 'Multiphase Optimization Strategy (MOST', 'Pump It Up']",['T1D self-management behaviors'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0577019,"There is a need for interventions to improve use of sophisticated diabetes technologies, such as insulin pumps, during adolescence - a very high-risk developmental period for individuals with T1D. All diabetes devices, including insulin pumps, store large amounts of behavioral data that can be downloaded and analyzed to evaluate adherence to recommended T1D self-management behaviors.","[{'ForeName': 'Holly K', 'Initials': 'HK', 'LastName': ""O'Donnell"", 'Affiliation': 'University of Colorado School of Medicine, Department of Pediatrics, Barbara Davis Center for Diabetes, 1775 Aurora Ct., Aurora, CO 80045, United States. Electronic address: holly.odonnell@cuanschutz.edu.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Vigers', 'Affiliation': 'University of Colorado School of Medicine, Department of Pediatrics, Barbara Davis Center for Diabetes, 1775 Aurora Ct., Aurora, CO 80045, United States. Electronic address: timothy.vigers@cuanschutz.edu.'}, {'ForeName': 'Suzanne Bennett', 'Initials': 'SB', 'LastName': 'Johnson', 'Affiliation': 'Florida State University, College of Medicine, Department of Clinical Sciences, 1115 W. Call Street, Tallahassee, FL 32306, United States. Electronic address: suzanne.johnson@med.fsu.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pyle', 'Affiliation': 'University of Colorado School of Medicine, Department of Pediatrics, Barbara Davis Center for Diabetes, 1775 Aurora Ct., Aurora, CO 80045, United States. Electronic address: laura.pyle@cuanschutz.edu.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Wright', 'Affiliation': 'Florida State University, College of Medicine, Department of Clinical Sciences, 1115 W. Call Street, Tallahassee, FL 32306, United States. Electronic address: nwright@fsu.edu.'}, {'ForeName': 'Larry C', 'Initials': 'LC', 'LastName': 'Deeb', 'Affiliation': 'Florida State University College of Medicine, Department of Medical Humanities and Social Sciences, 1115 W. Call Street, Tallahassee, FL 32306, United States. Electronic address: lcdeeb@yhoo.com.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Driscoll', 'Affiliation': 'University of Florida, Department of Clinical and Health Psychology, 1225 Center Dr., Gainesville, FL 32610, United States; University of Florida Diabetes Institute, College of Medicine, 1275 Center Dr., Gainesville, FL 32610, United States. Electronic address: k.driscoll@phhp.ufl.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106279']
333,33443079,A Randomized Clinical Trial of Anti-IL-6 Antibody Clazakizumab in Late Antibody-Mediated Kidney Transplant Rejection.,"BACKGROUND


Late antibody-mediated rejection (ABMR) is a leading cause of transplant failure. Blocking IL-6 has been proposed as a promising therapeutic strategy.
METHODS


We performed a phase 2 randomized pilot trial to evaluate the safety (primary endpoint) and efficacy (secondary endpoint analysis) of the anti-IL-6 antibody clazakizumab in late ABMR. The trial included 20 kidney transplant recipients with donor-specific, antibody-positive ABMR ≥365 days post-transplantation. Patients were randomized 1:1 to receive 25 mg clazakizumab or placebo (4-weekly subcutaneous injections) for 12 weeks (part A), followed by a 40-week open-label extension (part B), during which time all participants received clazakizumab.
RESULTS


Five (25%) patients under active treatment developed serious infectious events, and two (10%) developed diverticular disease complications, leading to trial withdrawal. Those receiving clazakizumab displayed significantly decreased donor-specific antibodies and, on prolonged treatment, modulated rejection-related gene-expression patterns. In 18 patients, allograft biopsies after 51 weeks revealed a negative molecular ABMR score in seven (38.9%), disappearance of capillary C4d deposits in five (27.8%), and resolution of morphologic ABMR activity in four (22.2%). Although proteinuria remained stable, the mean eGFR decline during part A was slower with clazakizumab compared with placebo (-0.96; 95% confidence interval [95% CI], -1.96 to 0.03 versus -2.43; 95% CI, -3.40 to -1.46 ml/min per 1.73 m 2  per month, respectively,  P =0.04). During part B, the slope of eGFR decline for patients who were switched from placebo to clazakizumab improved and no longer differed significantly from patients initially allocated to clazakizumab.
CONCLUSIONS


Although safety data indicate the need for careful patient selection and monitoring, our preliminary efficacy results suggest a potentially beneficial effect of clazakizumab on ABMR activity and progression.",2021,"Those receiving clazakizumab displayed significantly decreased donor-specific antibodies and, on prolonged treatment, modulated rejection-related gene-expression patterns.","['20 kidney transplant recipients with donor-specific, antibody-positive ABMR ≥365 days post-transplantation', 'late ABMR', 'Late Antibody-Mediated Kidney Transplant Rejection']","['placebo', 'clazakizumab or placebo', 'Blocking IL-6', 'clazakizumab', 'Anti-IL-6 Antibody Clazakizumab']","['mean eGFR decline', 'diverticular disease complications', 'serious infectious events', 'allograft biopsies', 'slope of eGFR decline', 'resolution of morphologic ABMR activity', 'ABMR activity and progression', 'negative molecular ABMR score', 'donor-specific antibodies', 'disappearance of capillary C4d deposits']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0238217', 'cui_str': 'Renal transplant rejection'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4077748', 'cui_str': 'clazakizumab'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1510475', 'cui_str': 'Diverticula of intestine'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0056195', 'cui_str': 'Complement component C4d'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}]",20.0,0.184286,"Those receiving clazakizumab displayed significantly decreased donor-specific antibodies and, on prolonged treatment, modulated rejection-related gene-expression patterns.","[{'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Doberer', 'Affiliation': 'Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Duerr', 'Affiliation': 'Department of Nephrology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Philip F', 'Initials': 'PF', 'LastName': 'Halloran', 'Affiliation': 'Alberta Transplant Applied Genomics Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Farsad', 'Initials': 'F', 'LastName': 'Eskandary', 'Affiliation': 'Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Klemens', 'Initials': 'K', 'LastName': 'Budde', 'Affiliation': 'Department of Nephrology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Regele', 'Affiliation': 'Department of Clinical Pathology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Reeve', 'Affiliation': 'Alberta Transplant Applied Genomics Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Borski', 'Affiliation': 'Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Kozakowski', 'Affiliation': 'Department of Clinical Pathology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Reindl-Schwaighofer', 'Affiliation': 'Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Waiser', 'Affiliation': 'Department of Nephrology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Lachmann', 'Affiliation': 'Centre for Tumor Medicine, Histocompatibility & Immunogenetics Laboratory, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schranz', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Firbas', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Mühlbacher', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Gelbenegger', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Perkmann', 'Affiliation': 'Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Wahrmann', 'Affiliation': 'Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kainz', 'Affiliation': 'Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Ristl', 'Affiliation': 'Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Halleck', 'Affiliation': 'Department of Nephrology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Bond', 'Affiliation': 'Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Chong', 'Affiliation': 'Vitaeris Inc., Vancouver, Canada.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Jilma', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria georg.boehmig@meduniwien.ac.at bernd.jilma@meduniwien.ac.at.'}, {'ForeName': 'Georg A', 'Initials': 'GA', 'LastName': 'Böhmig', 'Affiliation': 'Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria georg.boehmig@meduniwien.ac.at bernd.jilma@meduniwien.ac.at.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020071106']
334,33450335,Acute kidney injury after in-hospital cardiac arrest.,"AIM


Determine 1) frequency and risk factors for acute kidney injury (AKI) after in-hospital cardiac arrest (IHCA) in the Therapeutic Hypothermia after Pediatric Cardiac Arrest In-Hospital (THAPCA-IH) trial and associated outcomes; 2) impact of temperature management on post-IHCA AKI.
METHODS


Secondary analysis of THAPCA-IH; a randomized controlled multi-national trial at 37 children's hospitals.
ELIGIBILITY


Serum creatinine (Cr) within 24 h of randomization.
OUTCOMES


Prevalence of severe AKI defined by Stage 2 or 3 Kidney Disease Improving Global Outcomes Cr criteria. 12-month survival with favorable neurobehavioral outcome. Analyses stratified by entire cohort and cardiac subgroup. Risk factors and outcomes compared among cohorts with and without severe AKI.
RESULTS


Subject randomization: 159 to hypothermia, 154 to normothermia. Overall, 80% (249) developed AKI (any stage), and 66% (207) developed severe AKI. Cardiac patients (204, 65%) were more likely to develop severe AKI (72% vs 56%,p = 0.006). Preexisting cardiac or renal conditions, baseline lactate, vasoactive support, and systolic blood pressure were associated with severe AKI. Comparing hypothermia versus normothermia, there were no differences in severe AKI rate (63% vs 70%,p = 0.23), peak Cr, time to peak Cr, or freedom from mortality or severe AKI (p = 0.14). Severe AKI was associated with decreased hospital survival (48% vs 65%,p = 0.006) and decreased 12-month survival with favorable neurobehavioral outcome (30% vs 53%,p < 0.001).
CONCLUSION


Severe post-IHCA AKI occurred frequently especially in those with preexisting cardiac or renal conditions and peri-arrest hemodynamic instability. Severe AKI was associated with decreased survival with favorable neurobehavioral outcome. Hypothermia did not decrease incidence of severe AKI post-IHCA.",2021,"Severe AKI was associated with decreased hospital survival (48% vs 65%,p = 0.006) and decreased 12-month survival with favorable neurobehavioral outcome (30% vs 53%,p < 0.001).
","[""37 children's hospitals"", 'Acute kidney injury after in-hospital cardiac arrest']",['THAPCA-IH'],"['develop severe AKI', 'peak Cr, time to peak Cr, or freedom from mortality or severe AKI', 'severe AKI rate', '12-month survival with favorable neurobehavioral outcome', '12-month survival', 'hospital survival', 'severe AKI', 'Preexisting cardiac or renal conditions, baseline lactate, vasoactive support, and systolic blood pressure', 'survival with favorable neurobehavioral outcome']","[{'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",37.0,0.267372,"Severe AKI was associated with decreased hospital survival (48% vs 65%,p = 0.006) and decreased 12-month survival with favorable neurobehavioral outcome (30% vs 53%,p < 0.001).
","[{'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Mah', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, United States; The Heart Institute, Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States. Electronic address: Kenneth.Mah@cchmc.org.""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Alten', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, United States; The Heart Institute, Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States.""}, {'ForeName': 'Timothy T', 'Initials': 'TT', 'LastName': 'Cornell', 'Affiliation': ""Department of Pediatrics, Lucile Packard Children's Hospital Stanford, Stanford University, Palo Alto, CA, United States.""}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Selewski', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Askenazi', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Fitzgerald', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.""}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Topjian', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.""}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holubkov', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Beth S', 'Initials': 'BS', 'LastName': 'Slomine', 'Affiliation': 'Kennedy Krieger Institute and Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Christensen', 'Affiliation': 'Kennedy Krieger Institute and Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Dean', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Moler', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School, Ann Arbor, MI, United States.'}]",Resuscitation,['10.1016/j.resuscitation.2020.12.023']
335,33459945,Quantitative assessment of cytochrome C oxidase patterns in muscle tissue by the use of near-infrared spectroscopy (NIRS) in healthy volunteers.,"Cytochrome C oxidase (CCO) acts as final electron acceptor in the respiratory chain, possibly providing information concerning cellular oxygenation. CCO is a chromophore with a broad absorption peak in the near-infrared spectrum in its reduced state (835 nm). However, this peak overlaps with deoxygenated haemoglobin (HHb; 755 nm) which is present in much higher concentrations. NIRO-300 measures CCO signals, but did not receive FDA approval for this use due to presumed lack of independency of the measured CCO changes. However, there is no proven evidence for this assumption. We hypothesized that the NIRO-300 provides a HHb independent measurement of CCO concentration changes. In this single-center crossover randomized controlled trial in healthy volunteers, subjects were randomized to receive arterial occlusion to the left arm and venous stasis on the right arm (n = 5) or vice versa (n = 5) during 5 min. After a resting period, the second part of the cross over study was performed. We placed the NIRO-300 optodes bilateral at the level of the brachioradial muscle in order to collect NIRS data continuously. Data was analysed using a generalized additive mixed model. HHb and CCO follow a significant different trend over time during the intervention period for both arterial occlusion (F = 20.645, edf = 3.419, p < 0.001) and venous stasis (F = 9.309, edf = 4.931, p < 0.001). Our data indicate that CCO concentration changes were not affected by HHb changes, thereby proving independency.Clinical trial registration: B670201732023 on June 28, 2017.",2022,"HHb and CCO follow a significant different trend over time during the intervention period for both arterial occlusion (F = 20.645, edf = 3.419, p < 0.001) and venous stasis (F = 9.309, edf = 4.931, p < 0.001).",['healthy volunteers'],"['CCO', 'Cytochrome C oxidase (CCO']","['venous stasis', 'CCO concentration changes']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0010760', 'cui_str': 'Cytochrome c oxidase'}]","[{'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0010760', 'cui_str': 'Cytochrome c oxidase'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0625259,"HHb and CCO follow a significant different trend over time during the intervention period for both arterial occlusion (F = 20.645, edf = 3.419, p < 0.001) and venous stasis (F = 9.309, edf = 4.931, p < 0.001).","[{'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Verhaeghe', 'Affiliation': 'Department of Anaesthesia, UZ Ghent, Corneel Heymanslaan 10, 9000, Ghent, Belgium. verhaeghecarl@hotmail.com.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Lapage', 'Affiliation': 'Department of Anaesthesia, ASZ Aalst, Aalst, Belgium.'}, {'ForeName': 'Anneliese', 'Initials': 'A', 'LastName': 'Moerman', 'Affiliation': 'Department of Anaesthesia, UZ Ghent, Corneel Heymanslaan 10, 9000, Ghent, Belgium.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-021-00648-6']
336,33444934,Longitudinal investigation of the relationship between omega-3 polyunsaturated fatty acids and neuropsychological functioning in recent-onset psychosis: A randomized clinical trial.,"Alterations in polyunsaturated fatty acids (PUFAs), including omega-3 and omega-6, have been implicated in the pathophysiology of psychotic disorders, but little is known about their associations with neuropsychological functioning. The present study includes 46 recent-onset psychosis patients who participated in a larger (n = 50) double blind, placebo-controlled randomized clinical trial comparing 16 weeks of treatment with either risperidone + fish oil (FO) (EPA 740 mg and DHA 400 mg daily) or risperidone + placebo and completed neuropsychological assessments at the baseline timepoint. We investigated the relationship between baseline omega-3 (i.e., eicosapentaenoic acid, EPA; docosapentaenoic acid, DPA and docosahexaenoic acid, DHA) and omega-6 (i.e., arachidonic acid, AA) PUFA with baseline MATRICS Consensus Cognitive Battery (MCCB) and Brief Psychiatric Rating Scale (BPRS) scores. Twenty-five patients had neuropsychological data available at 16 weeks following participation in the clinical trial, which included 12 patients assigned to risperidone + FO and 13 patients assigned to risperidone + placebo. At baseline both higher DHA and EPA correlated significantly with better social cognition after controlling for functioning on other neuropsychological domains, total BPRS score, AA level and substance use. Also, at baseline higher AA correlated significantly with hostility/uncooperativeness after controlling for DHA + EPA + DPA, overall neuropsychological functioning and substance use. Patients treated with risperidone + FO demonstrated a significant longitudinal increase in social cognition that was significantly higher at 16 weeks compared to patients treated with risperidone + placebo. DHA also correlated significantly with social cognition at the 16-week timepoint. This study provides novel evidence for a differential role of omega-3 vs. omega-6 PUFA in neuropsychological deficits and symptoms in recent-onset psychosis and its treatment.",2021,Patients treated with risperidone + FO demonstrated a significant longitudinal increase in social cognition that was significantly higher at 16 weeks compared to patients treated with risperidone + placebo.,"['46 recent-onset psychosis patients who participated in a larger (n\xa0=\xa050) double blind', 'Twenty-five patients had neuropsychological data available at 16\xa0weeks following participation in the clinical trial, which included 12 patients assigned to', 'recent-onset psychosis']","['omega-3 vs. omega-6 PUFA', 'EPA 740\xa0mg and DHA 400\xa0mg daily) or risperidone\xa0+\xa0placebo', 'placebo', 'omega-3 polyunsaturated fatty acids', 'risperidone\xa0+\xa0placebo', 'risperidone\xa0+\xa0fish oil (FO', 'risperidone\xa0+\xa0FO']","['baseline omega-3 (i.e., eicosapentaenoic acid, EPA; docosapentaenoic acid, DPA and docosahexaenoic acid, DHA) and omega-6 (i.e., arachidonic acid, AA) PUFA with baseline MATRICS Consensus Cognitive Battery (MCCB) and Brief Psychiatric Rating Scale (BPRS) scores', 'social cognition', 'total BPRS score, AA level and substance use']","[{'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0133860', 'cui_str': 'Fatty Acids, Omega-6'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]",12.0,0.434911,Patients treated with risperidone + FO demonstrated a significant longitudinal increase in social cognition that was significantly higher at 16 weeks compared to patients treated with risperidone + placebo.,"[{'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Szeszko', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America; James J. Peters VA Medical Center, Mental Illness Research, Education and Clinical Center, Bronx, NY, United States of America. Electronic address: philip.szeszko@mssm.edu.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'McNamara', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Lipidomics Research Program, University of Cincinnati, Cincinnati, OH, United States of America.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Gallego', 'Affiliation': 'Feinstein Institutes for Medical Research, Manhasset, NY, United States of America; Departments of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America.'}, {'ForeName': 'Anil K', 'Initials': 'AK', 'LastName': 'Malhotra', 'Affiliation': 'Feinstein Institutes for Medical Research, Manhasset, NY, United States of America; Departments of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Govindarajulu', 'Affiliation': 'Center for Biostatistics, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, NY, NY, United States of America.'}, {'ForeName': 'Bart D', 'Initials': 'BD', 'LastName': 'Peters', 'Affiliation': 'Feinstein Institutes for Medical Research, Manhasset, NY, United States of America.'}, {'ForeName': 'Delbert G', 'Initials': 'DG', 'LastName': 'Robinson', 'Affiliation': 'Feinstein Institutes for Medical Research, Manhasset, NY, United States of America; Departments of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America.'}]",Schizophrenia research,['10.1016/j.schres.2020.11.050']
337,33429088,The effect of reducing posttraumatic stress disorder symptoms on cardiovascular risk: Design and methodology of a randomized clinical trial.,"Posttraumatic stress disorder (PTSD) has been associated with accelerated progression of coronary heart disease (CHD). However, the underlying pathophysiological pathway has remained elusive and it is unclear whether there is a direct link between PTSD and CHD risk. This paper describes the methods of a randomized controlled trial developed to examine how changes in PTSD symptoms affect CHD disease pathways. One hundred twenty participants with current PTSD and who are free of known CHD will be randomized to receive either an evidence-based treatment for PTSD (Cognitive Processing Therapy; CPT) or a waitlist control (WL). Before and after CPT/WL, participants undergo assessment of CHD risk biomarkers reflecting autonomic nervous system dysregulation, systemic inflammation, and vascular endothelial dysfunction. The primary hypothesis is that individuals who show improvement in PTSD symptoms will show improvement in CHD risk biomarkers, whereas individuals who fail to improve or show worsening PTSD symptoms will have no change or worsening in CHD biomarkers. This study is expected to provide knowledge of the role of both the direct impact of PTSD symptoms on CHD risk pathways and the role of these systems as candidate mechanisms underlying the relationship between PTSD and CHD risk. Further, results will provide guidance on the utility of cognitive therapy as a tool to mitigate the accelerated progression of CHD in PTSD. Clinical Trials Registration: https://clinicaltrials.gov/ct2/show/NCT02736929; Unique identifier: NCT02736929.",2021,"Before and after CPT/WL, participants undergo assessment of CHD risk biomarkers reflecting autonomic nervous system dysregulation, systemic inflammation, and vascular endothelial dysfunction.","['Posttraumatic stress disorder (PTSD', 'One hundred twenty participants with current PTSD and who are free of known CHD']",['evidence-based treatment for PTSD (Cognitive Processing Therapy; CPT) or a waitlist control (WL'],['CHD risk biomarkers'],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1277690', 'cui_str': 'Coronary heart disease risk'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",120.0,0.0349641,"Before and after CPT/WL, participants undergo assessment of CHD risk biomarkers reflecting autonomic nervous system dysregulation, systemic inflammation, and vascular endothelial dysfunction.","[{'ForeName': 'Stefanie T', 'Initials': 'ST', 'LastName': 'LoSavio', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Beckham', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA.'}, {'ForeName': 'Stephanie Y', 'Initials': 'SY', 'LastName': 'Wells', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA; VA Mid-Atlantic Mental Illness Research, Education, and Clinical Center, Durham, NC, United States of America.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Resick', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sherwood', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'VA Mid-Atlantic Mental Illness Research, Education, and Clinical Center, Durham, NC, United States of America; Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Healthcare System, Durham, NC, United States of America.'}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Kirby', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA; VA Mid-Atlantic Mental Illness Research, Education, and Clinical Center, Durham, NC, United States of America.'}, {'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Beaver', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA.'}, {'ForeName': 'Michelle F', 'Initials': 'MF', 'LastName': 'Dennis', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA.'}, {'ForeName': 'Lana L', 'Initials': 'LL', 'LastName': 'Watkins', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA. Electronic address: lana.watkins@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106269']
338,33434704,"Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline.","Alzheimer's dementia (AD) is the sixth leading cause of death in the U.S., with an estimated $305 billion cost of care in 2020. Currently there are no cures or therapies to ameliorate the disease progression and symptoms. Growing evidence links a diet characterized by high antioxidant components with benefits to cognitive function, which is indicative of the preventative potential of dietary inteventions. The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study is a 3-year, multicenter, randomized controlled trial to test the effects of the MIND diet on cognitive function in 604 individuals at risk for AD. Men and women ages 65 to 84 years were recruited. Eligible participants were randomized to either the MIND diet with mild caloric restriction or their usual diet with mild caloric restriction. Cognitive assessments, medical history, blood pressure, anthropometric measurements, and blood and urine sample collections will be taken at baseline and follow-up visits. MRI scans will be completed on approximately half of the enrolled participants at the start and end of the study. Unique features of the MIND study include: 1) a dietary pattern, rather than single nutrient or food, tested in an at-risk population; 2) foods featured as key components of the MIND diet (i.e. extra-virgin olive oil, blueberries, and nuts) provided for participants; and 3) MRI scans of brain structure and volume that may provide potential mechanistic evidence on the effects of the diet. Results from the study will be crucial to the development of dietary guidelines for the prevention of AD.",2021,Eligible participants were randomized to either the MIND diet with mild caloric restriction or their usual diet with mild caloric restriction.,"[""Alzheimer's dementia (AD"", '604 individuals at risk for AD', 'Men and women ages 65 to 84\u202fyears were recruited', 'Eligible participants']","['Mediterranean-DASH intervention', 'Mediterranean-DASH Intervention', 'MIND diet with mild caloric restriction or their usual diet with mild caloric restriction', 'MIND diet']","['cognitive decline', 'Cognitive assessments, medical history, blood pressure, anthropometric measurements, and blood and urine sample collections', 'cognitive function']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0810864,Eligible participants were randomized to either the MIND diet with mild caloric restriction or their usual diet with mild caloric restriction.,"[{'ForeName': 'Xiaoran', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, IL, United States of America; Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Martha Clare', 'Initials': 'MC', 'LastName': 'Morris', 'Affiliation': 'Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, IL, United States of America; Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Klodian', 'Initials': 'K', 'LastName': 'Dhana', 'Affiliation': 'Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, IL, United States of America; Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ventrelle', 'Affiliation': 'Department of Preventive Medicine, Rush Medical College, Chicago, IL, United States of America.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': ""Department of Nutrition, Harvard School of Public Health, Boston, MA, United States of America; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Bishop', 'Affiliation': ""Department of Nutrition, Harvard School of Public Health, Boston, MA, United States of America; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Chiquia S', 'Initials': 'CS', 'LastName': 'Hollings', 'Affiliation': 'Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, IL, United States of America; Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Adrianna', 'Initials': 'A', 'LastName': 'Boulin', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Laranjo', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Stubbs', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Reilly', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Carey', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Rush Institute for Healthy Aging, Rush University Medical Center, Chicago, IL, United States of America; Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Furtado', 'Affiliation': 'Department of Nutrition, Harvard School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Santica M', 'Initials': 'SM', 'LastName': 'Marcovina', 'Affiliation': 'Northwest Lipid Metabolism and Diabetes Research Laboratories, Seattle, WA, United States of America.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Tangney', 'Affiliation': 'Department of Preventive Medicine, Rush Medical College, Chicago, IL, United States of America; Department of Clinical Nutrition, Rush Medical College, Chicago, IL, United States of America.'}, {'ForeName': 'Neelum T', 'Initials': 'NT', 'LastName': 'Aggarwal', 'Affiliation': ""Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, United States of America; Department of Neurology, Rush University Medical Center, Chicago, IL, United States of America.""}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Arfanakis', 'Affiliation': ""Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, United States of America; Department of Diagnostic Radiology and Nuclear Medicine, Rush University Medical Center, Chicago, IL, United States of America; Department of Biomedical Engineering, Illinois Institute of Technology, Chicago, IL, United States of America.""}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Lisa L', 'Initials': 'LL', 'LastName': 'Barnes', 'Affiliation': ""Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, United States of America; Department of Neurology, Rush University Medical Center, Chicago, IL, United States of America. Electronic address: Lisa_L_Barnes@rush.edu.""}]",Contemporary clinical trials,['10.1016/j.cct.2021.106270']
339,33452108,Improved Cognitive Promotion through Accelerated Magnetic Stimulation.,"Noninvasive brain stimulation to enhance cognition is an area of increasing research interest. Theta burst stimulation (TBS) is a novel accelerated form of stimulation, which more closely mimics the brain's natural firing patterns and may have greater effects on cognitive performance. We report here the comparative assessment of the effect of conventional high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) protocols and TBS protocols on cognition enhancement in healthy controls. Sixty healthy adults (34 males and 26 females) were randomized and counterbalanced and assigned to HF-rTMS ( n  = 20), TBS ( n  = 20), or sham ( n  = 20) groups. The promotion effects of different parameters of prefrontal stimulation on working memory and executive function were compared, as assessed by performance in N-back tasks and the Wisconsin Card Sorting Test (WCST). Both HF-rTMS and intermittent TBS (iTBS) groups displayed a significant improvement in N-back tasks, with an effect size of 0.79 and 1.50, respectively. Furthermore, the iTBS group displayed a significant improvement in the WCST, with an effect size of 0.84. The iTBS group demonstrated higher effect sizes than the HF-rTMS group ( t  =   2.68,  p  =   0.011), with an effect size of 0.85. However, no improvement in other tasks was observed ( p  >   0.05). Intermittent TBS has a stronger cognitive promoting effect than conventional rTMS. In summary, our findings provide direct evidence that iTBS may be a superior protocol for cognitive promotion.",2021,"The iTBS group demonstrated higher effect sizes than the HF-rTMS group ( t =2.68,  P =0.011), with an effect size of 0.85.","['healthy controls', 'Sixty healthy adults (34 males and 26 females']","['HF-rTMS', '20 Hz rTMS and iTBS', 'HF-rTMS and intermittent TBS (iTBS', 'placebo', 'Theta burst stimulation (TBS', 'TBS', 'conventional high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) protocols and TBS protocols', 'Noninvasive brain stimulation']","['cognition enhancement', 'executive function (cognitive flexibility) performance', 'working memory and executive function']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",60.0,0.139158,"The iTBS group demonstrated higher effect sizes than the HF-rTMS group ( t =2.68,  P =0.011), with an effect size of 0.85.","[{'ForeName': 'Xingqi', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': ""Department of Neurology, Second People's Hospital of Hefei City, The Hefei Affiliated Hospital of Anhui Medical University, Hefei 230022, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Chengjuan', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Xingui', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Gong-Jun', 'Initials': 'GJ', 'LastName': 'Ji', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Yanghua', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China wangkai1964@126.com ayfytyh@126.com.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China wangkai1964@126.com ayfytyh@126.com.'}]",eNeuro,['10.1523/ENEURO.0392-20.2020']
340,33453008,Comparison of two forced air warming systems for prevention of intraoperative hypothermia in carcinoma colon patients: a prospective randomized study.,"Hypothermia is common occurrence in patients undergoing colonic surgeries. We hypothesized that the underbody forced air warming blankets will be better than conventional over-body forced air warming blankets for prevention of hypothermia during laparoscopic colon surgeries. After ethics approval, sixty patients undergoing elective laparoscopic colon surgeries were randomly divided into two groups to receive warming by underbody forced air warming blanket (n = 30) or over-body forced air warming blanket (n = 30). In the operating room, epidural catheter was inserted and thereafter warming was started with the forced air warmer with temperature set at 44 °C. Intraoperatively core temperature (using nasopharyngeal probe), vitals, incidence of postoperative shivering and time to reach Aldrete Score of 10 in the postoperative period were recorded. The core temperature was higher with an underbody blanket at 60 min (36.1 ± 0.5 °C vs. 35.7 ± 0.5 °C, P = 0.005), 90 min (35.9 ± 0.5 °C vs. 35.6 ± 0.5 °C, P = 0.009), 120 min (35.9 ± 0.5 °C vs. 35.5 ± 0.4 °C, P = 0.007), and 150 min (35.9 ± 0.5 °C vs. 35.6 ± 0.4 °C, P = 0.011). In the post anesthesia care unit, the time to reach an Aldrete score of 10 was also less in the underbody blanket group (14.3 ± 2.5 min vs. 16.8 ± 3.6 min) (P = 0.003). However, there were no clinically meaningful differences in any outcome. Underbody and over-body blankets were comparably effective in preventing hypothermia in patients undergoing laparoscopic colorectal surgery under general anaesthesia.Trial registration CTRI (2019/06/019,576). Date of Registration: June 2019, Prospectively registered.",2022,Underbody and over-body blankets were comparably effective in preventing hypothermia in patients undergoing laparoscopic colorectal surgery under general anaesthesia.,"['carcinoma colon patients', 'patients undergoing colonic surgeries', 'sixty patients undergoing elective laparoscopic colon surgeries', 'patients undergoing laparoscopic colorectal surgery under general anaesthesia']","['two forced air warming systems', 'warming by underbody forced air warming blanket (n\u2009=\u200930) or over-body forced air warming blanket', 'Underbody and over-body blankets', 'Hypothermia']",[],"[{'cui': 'C0699790', 'cui_str': 'Carcinoma of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192817', 'cui_str': 'Operation on colon'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0184351', 'cui_str': 'Warming blanket'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0179330', 'cui_str': 'Blanket'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}]",[],60.0,0.0526935,Underbody and over-body blankets were comparably effective in preventing hypothermia in patients undergoing laparoscopic colorectal surgery under general anaesthesia.,"[{'ForeName': 'Abhity', 'Initials': 'A', 'LastName': 'Gulia', 'Affiliation': 'Department of Onco-Anesthesia and Palliative Medicine, Dr.B.R. Ambedkar, IRCH, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Nishkarsh', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, Dr.B.R. Ambedkar, IRCH, All India Institute of Medical Sciences, Room No 139, First floor, New Delhi, India. drnishkarshgupta@gmail.com.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Onco-Anesthesia and Palliative Medicine, Dr.B.R. Ambedkar, IRCH, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bhoriwal', 'Affiliation': 'Department of Surgical Oncology, Dr.B.R. Ambedkar, IRCH, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajeev Kumar', 'Initials': 'RK', 'LastName': 'Malhotra', 'Affiliation': 'Delhi Cancer Registry, Dr.B.R. Ambedkar, IRCH, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sachidanand Jee', 'Initials': 'SJ', 'LastName': 'Bharti', 'Affiliation': 'Department of Onco-Anesthesia and Palliative Medicine, Dr.B.R. Ambedkar, IRCH, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': 'Department of Onco-Anesthesia and Palliative Medicine, Dr.B.R. Ambedkar, IRCH, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'Department of Onco-Anesthesia and Palliative Medicine, Dr.B.R. Ambedkar, IRCH, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Onco-Anesthesia and Palliative Medicine, Dr.B.R. Ambedkar, IRCH, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00639-z']
341,33461782,Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma: Final Overall Survival Analysis of the Phase 3 PROTECT Trial.,"Most studies indicate no benefit of adjuvant therapy with VEGFR tyrosine kinase inhibitors in advanced renal cell carcinoma (RCC). PROTECT (NCT01235962) was a randomized, double-blind, placebo-controlled phase 3 study to evaluate adjuvant pazopanib in patients with locally advanced RCC at high risk of relapse after nephrectomy (pazopanib, n = 769; placebo, n = 769). The results of the primary analysis showed no difference in disease-free survival between pazopanib 600 mg and placebo. Here we report the final overall survival (OS) analysis (median follow-up: pazopanib, 76 mo, interquartile range [IQR] 66-84; placebo, 77 mo, IQR 69-85). There was no significant difference in OS between the pazopanib and placebo arms (hazard ratio 1.0, 95% confidence interval 0.80-1.26; nominal p > 0.9). OS was worse for patients with T4 disease compared to those with less advanced disease and was better for patients with body mass index (BMI) ≥30 kg/m 2  compared to those with lower BMI. OS was significantly better for patients who remained diseasefree at 2 yr after treatment compared with those who relapsed within 2 yr. These findings are consistent with the primary outcomes from PROTECT, indicating that adjuvant pazopanib does not confer a benefit in terms of OS for patients following resection of locally advanced RCC. PATIENT SUMMARY: In the randomized, double-blind, placebo-controlled phase 3 PROTECT study, overall survival was similar for patients with locally advanced renal cell carcinoma (RCC) at high risk of relapse after nephrectomy who received adjuvant therapy with pazopanib or placebo. Pazopanib is not recommended as adjuvant therapy following resection of locally advanced RCC. This trial is registered at Clinicaltrials.gov as NCT01235962.",2021,The results of the primary analysis showed no difference in disease-free survival between pazopanib 600 mg and placebo.,"['patients with locally advanced renal cell carcinoma (RCC) at high risk of relapse after nephrectomy who received adjuvant therapy with', 'patients with locally advanced RCC at high risk of relapse after nephrectomy (pazopanib, n\u2009=\u2009769; placebo, n\u2009=\u2009769', 'Patients With Localized or Locally Advanced Renal Cell Carcinoma', 'advanced renal cell carcinoma (RCC', 'patients following resection of locally advanced RCC']","['Pazopanib', 'placebo', 'pazopanib or placebo', 'VEGFR tyrosine kinase inhibitors', 'pazopanib', 'Adjuvant Pazopanib Versus Placebo']","['OS', 'final overall survival (OS) analysis', 'disease-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.790081,The results of the primary analysis showed no difference in disease-free survival between pazopanib 600 mg and placebo.,"[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: motzerr@mskcc.org.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Russo', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Haas', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Doehn', 'Affiliation': 'University of Lubeck Medical School and Urologikum Lubeck, Lubeck, Germany.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Gross-Goupil', 'Affiliation': 'Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Sergei', 'Initials': 'S', 'LastName': 'Varlamov', 'Affiliation': 'Altai Regional Cancer Center, Barnaul, Russia.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Kopyltsov', 'Affiliation': 'State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia.'}, {'ForeName': 'Jae Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic.'}, {'ForeName': 'Milada', 'Initials': 'M', 'LastName': 'Zemanova', 'Affiliation': 'Charles University and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Rini', 'Affiliation': 'Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Wood', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'M Neil', 'Initials': 'MN', 'LastName': 'Reaume', 'Affiliation': 'The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'University Hospital Tubingen, Tubingen, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Guy's and St Thomas' National Health Service Foundation, St. Thomas' Hospital, London, UK.""}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'McDermott', 'Affiliation': 'Tallaght University Hospital and Cancer Trials Ireland, Dublin, Ireland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Michael', 'Affiliation': 'University of Surrey, Guildford, UK.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Novartis Oncology, East Hanover, NJ, USA.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Aimone', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Novartis Oncology, East Hanover, NJ, USA.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2020.12.029']
342,33423141,Testing the sleep hygiene recommendation against nighttime exercise.,"PURPOSE


Experts have recommended exercise for improved sleep, but often with the caveat that one should avoid nighttime exercise. The aim of this study was to challenge this recommendation in a sample who might be most prone to sleep impairment after nighttime exercise. The secondary aims were to assess whether or not post-treatment sleep was correlated with anxiolytic effects or downregulation of body temperature.
METHODS


Twelve sedentary adults with insomnia completed two treatments (separated by 2-5 days) in counterbalanced order: (1) 30 min of moderate treadmill exercise (60-70% maximum heart rate) + 15 min of moderate resistance exercise and (2) a control treatment (reading). Each treatment was completed 2 h before bedtime and followed by a 10-min shower, a light snack, 8 h of polysomnographic recording, and a sleep questionnaire. State anxiety was assessed before and 30 min after each treatment and 10 min before bedtime. Body temperature was assessed from pre-exercise to wake time.
RESULTS


No significant treatment differences in sleep were found, and Hedges g paired comparisons indicated small effect sizes; however, two participants had severely disturbed objective sleep following exercise. Significant correlations were found between change in state anxiety from pre-exercise to bedtime and TST (r = 0.69, p = 0.03). Stage 1 (r = 0.67, p = 0.03), WASO (r = 0.69, p = 0.03), and sleep efficiency (r = 0.66, p = 0.02). No significant correlations were found of sleep with temperature decline.
CONCLUSIONS


Profound sleep disturbance after exercise in some participants, and no marked sleep improvement in the others, provides some support for caution regarding late-night exercise for sedentary individuals with insomnia.",2021,"No significant treatment differences in sleep were found, and Hedges g paired comparisons indicated small effect sizes; however, two participants had severely disturbed objective sleep following exercise.","['sedentary individuals with insomnia', 'Twelve sedentary adults with insomnia completed two treatments (separated by 2-5 days) in counterbalanced order: (1) 30 min of']",['moderate treadmill exercise (60-70% maximum heart rate) + 15 min of moderate resistance exercise and (2) a control treatment (reading'],"['Body temperature', 'sleep', 'state anxiety', 'severely disturbed objective sleep', 'anxiolytic effects or downregulation of body temperature', 'State anxiety', 'sleep efficiency', 'sleep with temperature decline', 'WASO']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C3179404', 'cui_str': 'Anti-Anxiety Effects'}, {'cui': 'C0013081', 'cui_str': 'Down-regulation'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",12.0,0.0628544,"No significant treatment differences in sleep were found, and Hedges g paired comparisons indicated small effect sizes; however, two participants had severely disturbed objective sleep following exercise.","[{'ForeName': 'Shawn D', 'Initials': 'SD', 'LastName': 'Youngstedt', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, USA. Shawn.youngstedt@asu.edu.'}, {'ForeName': 'Wakako', 'Initials': 'W', 'LastName': 'Ito', 'Affiliation': 'Institute of Neuropsychiatry, Tokyo, Japan.'}, {'ForeName': 'Giselle Soares', 'Initials': 'GS', 'LastName': 'Passos', 'Affiliation': 'Universidade Federal de Jataí, Jataí, GO, Brazil.'}, {'ForeName': 'Marcos Gonçalves', 'Initials': 'MG', 'LastName': 'Santana', 'Affiliation': 'Universidade Federal de Jataí, Jataí, GO, Brazil.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Youngstedt', 'Affiliation': 'Red Mountain High School, Mesa, AZ, USA.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02284-x']
343,33497833,"Behavioral cancer pain intervention using videoconferencing and a mobile application for medically underserved patients: Rationale, design, and methods of a prospective multisite randomized controlled trial.","BACKGROUND


Women with breast cancer in medically underserved areas are particularly vulnerable to persistent pain and disability. Behavioral pain interventions reduce pain and improve outcomes. Cancer patients in medically underserved areas receive limited adjunctive cancer care, as many lack access to pain therapists trained in behavioral interventions, face travel barriers to regional medical centers, and may have low literacy and limited resources. mHealth technologies have the potential to decrease barriers but must be carefully adapted for, and efficacy-tested with, medically underserved patients. We developed an mHealth behavioral pain coping skills training intervention (mPCST-Community). We now utilize a multisite randomized controlled trial to: 1) test the extent mPCST-Community reduces breast cancer patients' pain severity (primary outcome), pain interference, fatigue, physical disability, and psychological distress; 2) examine potential mediators of intervention effects; and 3) evaluate the intervention's cost and cost-effectiveness.
METHODS/DESIGN


Breast cancer patients (N = 180) will be randomized to mPCST-Community or an attention control. mPCST-Community's four-session protocol will be delivered via videoconferencing at an underserved community clinic by a remote pain therapist at a major medical center. Videoconference sessions will be supplemented with a mobile application. Participants will complete self-report measures at baseline, post-intervention, and 3- and 6-month follow-ups.
CONCLUSIONS


mPCST-Community has the potential to reduce pain and disability, and decrease barriers for cancer patients in medically underserved areas. This is one of the first trials to test an mHealth behavioral cancer pain intervention developed specifically for medically underserved communities. If successful, it could lead to widespread implementation and decreased health disparities.",2021,"CONCLUSIONS


mPCST-Community has the potential to reduce pain and disability, and decrease barriers for cancer patients in medically underserved areas.","['medically underserved patients', 'cancer patients in medically underserved areas', 'reduces breast cancer patients', 'Women with breast cancer in medically underserved areas', 'medically underserved communities', 'Cancer patients in medically underserved areas receive limited adjunctive cancer care', 'Breast cancer patients (N\u202f=\u202f180']","['Videoconference sessions', 'mHealth behavioral pain coping skills training intervention (mPCST-Community', 'mPCST-Community or an attention control', 'Behavioral pain interventions', 'Behavioral cancer pain intervention using videoconferencing and a mobile application', 'mHealth behavioral cancer pain intervention', 'mPCST-Community']","[""intervention's cost and cost-effectiveness"", 'pain severity (primary outcome), pain interference, fatigue, physical disability, and psychological distress', 'pain and disability']","[{'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025112', 'cui_str': 'Area, Medically Underserved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",180.0,0.108694,"CONCLUSIONS


mPCST-Community has the potential to reduce pain and disability, and decrease barriers for cancer patients in medically underserved areas.","[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Kelleher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Winger', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Shelby D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Population Health Sciences, Duke University Medical Center, Durham, NC, USA; Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Beverly E', 'Initials': 'BE', 'LastName': 'Thorn', 'Affiliation': 'The Department of Psychology, The University of Alabama, Tuscaloosa, AL, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Samsa', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA; Duke Cancer Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Majestic', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Shelby', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Sutton', 'Affiliation': 'Duke Cancer Network, Duke University, Durham, NC, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Somers', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA. Electronic address: tamara.somers@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106287']
344,23103453,The ACTIVE cognitive training interventions and trajectories of performance among older adults.,"OBJECTIVES


Salthouse illustrated that among Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) participants, cognitive change accelerated following training. Our goal was to determine if this finding persists net of practice, training, and loss of training gains effects.
METHODS


We evaluated change over 5 years following cognitive training among older adults (N = 1,659, age 65 to 94).
RESULTS


Reasoning training, but not memory or speed, attenuated aging-related change. Memory gains were maintained, but about half of reasoning and speed gains were lost. Performance differences at the end of the follow-up were equivalent to about 6, 4, and 8 years of aging for memory, reasoning, and speed training, respectively.
DISCUSSION


Training can appear to accelerate age-related change, because change over time is coupled with loss of training gains. Our analysis is limited by follow-up that is short for precisely characterizing aging-related change.",2013,"Performance differences at the end of the follow-up were equivalent to about 6, 4, and 8 years of aging for memory, reasoning, and speed training, respectively.
","['older adults (N = 1,659, age 65 to 94', 'older adults']","['Reasoning training', 'cognitive training']","['memory or speed, attenuated aging-related change', 'Memory gains']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",1659.0,0.0260571,"Performance differences at the end of the follow-up were equivalent to about 6, 4, and 8 years of aging for memory, reasoning, and speed training, respectively.
","[{'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': 'Hebrew SeniorLife, Boston, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marsiske', 'Affiliation': ''}, {'ForeName': 'Karlene', 'Initials': 'K', 'LastName': 'Ball', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Rebok', 'Affiliation': ''}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'Willis', 'Affiliation': ''}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Tennstedt', 'Affiliation': ''}]",Journal of aging and health,['10.1177/0898264312461938']
345,33500235,Feasibility of an Updated Randomised Controlled Trial on Surgical Urolithiasis Treatments: The Pilot Trial for the German Endoscopic versus Shock Wave Therapy Study (GESS).,"Data comparing treatments for urolithiasis are often outdated, with inconsistent results or poor methodological and reporting quality. We report a pilot study in preparation for a larger multicentre randomised controlled trial (RCT) comparing shockwave therapy and ureteroscopy in patients with a single urinary stone of ≤20 mm in the upper urinary tract. Primary objectives included screening completeness, patients' willingness to participate, their remaining in the study, the suitability of the eligibility criteria, and the acceptability of the outcome measures. Screened individuals not invited to participate were those with no indication for active treatment among referred patients (n = 166), those who staff failed to screen (n = 99), and patients not meeting the inclusion criterion of a single stone (n = 422). Of the 176 patients invited, 116 refused to participate. Ultimately, we were able to recruit 60 patients within 34 mo. All patients underwent their allocated treatments. This pilot trial provides an in-depth analysis of the feasibility of an RCT on surgical treatments for upper urinary tract urolithiasis in a highly regulated health care system. The study procedures and outcome measures proved acceptable and feasible. On the basis of these data, we propose a pragmatic, multicentre RCT to deliver updated, high-level evidence on the efficacy of currently available treatments for urolithiasis. PATIENT SUMMARY: We performed a small pilot trial comparing current treatments in urolithiasis. We were able to prove the feasibility of a larger multi-institutional trial with regard to the time needed to recruit an adequate number of patients and the acceptability of the treatments and outcome measures.",2022,We were able to prove the feasibility of a larger multi-institutional trial with regard to the time needed to recruit an adequate number of patients and the acceptability of the treatments and outcome measures.,"['patients with a single urinary stone of ≤20 mm in the upper urinary tract', 'Screened individuals not invited to participate were those with no indication for active treatment among referred patients (n = 166), those who staff failed to screen (n = 99), and patients not meeting the inclusion criterion of a single stone (n = 422', '176 patients invited, 116 refused to participate', '60 patients within 34 mo']","['German Endoscopic versus Shock Wave Therapy Study (GESS', 'shockwave therapy and ureteroscopy', 'RCT', 'Surgical Urolithiasis Treatments']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042018', 'cui_str': 'Urolith'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0521090', 'cui_str': 'No indication of'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}]","[{'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0451641', 'cui_str': 'Urolithiasis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],422.0,0.0513197,We were able to prove the feasibility of a larger multi-institutional trial with regard to the time needed to recruit an adequate number of patients and the acceptability of the treatments and outcome measures.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schoenthaler', 'Affiliation': 'Department of Urology, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. Electronic address: martin.schoenthaler@uniklinik-freiburg.de.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hein', 'Affiliation': 'Department of Urology, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Urology, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Philippe-Fabian', 'Initials': 'PF', 'LastName': 'Pohlmann', 'Affiliation': 'Department of Urology, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Praus', 'Affiliation': 'Department of Urology, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Tabea', 'Initials': 'T', 'LastName': 'Walther', 'Affiliation': 'Department of Urology, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Schmoor', 'Affiliation': 'Clinical Trials Unit, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gratzke', 'Affiliation': 'Department of Urology, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Arkadiusz', 'Initials': 'A', 'LastName': 'Miernik', 'Affiliation': 'Department of Urology, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}]",European urology focus,['10.1016/j.euf.2021.01.001']
346,33479836,One-anastomosis gastric bypass (OAGB) with fixed bypass of the proximal two meters versus tailored bypass of the proximal one-third of small bowel: short-term outcomes.,"BACKGROUND


One-anastomosis gastric bypass (OAGB) is an effective bariatric procedure that confers satisfactory weight loss and improvement in comorbidities. The present study aimed to compare OAGB with fixed bypass of the proximal 200 cm of small bowel and tailored bypass of the proximal 1/3 of bowel.
METHODS


Patients with class II/III obesity underwent OAGB with either fixed bypass of the proximal two meters or tailored bypass of the proximal 1/3 of bowel. The main outcomes of the study were weight loss, improvement in comorbidities, complications, and changes in nutritional parameters after each technique.
RESULTS


The present study included 80 patients (62 female) of a mean age of 41 years and mean body mass index (BMI) of 50.9 kg/m 2 . The tailored bypass group was followed by a significantly lower BMI and significantly higher excess weight loss and total weight loss at 6 and 12 months postoperatively. There was no significant difference between the two groups in terms of improvement in comorbidities. The fixed bypass group was associated with a significantly higher complication rate than the tailored bypass group (22.5 vs. 5%, P = 0.04). Both groups were associated with similar changes in the nutritional parameters at 12 months postoperatively, except for the higher serum albumin levels after the tailored bypass than the fixed bypass.
CONCLUSIONS


OAGB with tailored bypass of the proximal one-third of bowel was associated with greater weight loss and comparable improvement in comorbidities as compared to fixed bypass of the proximal two meters of intestine.",2022,"Both groups were associated with similar changes in the nutritional parameters at 12 months postoperatively, except for the higher serum albumin levels after the tailored bypass than the fixed bypass.
","['Patients with class II/III obesity underwent OAGB with either fixed bypass of the proximal two meters or tailored bypass of the proximal 1/3 of bowel', '80 patients (62 female) of a mean age of 41\xa0years and mean body mass index (BMI) of 50.9\xa0kg/m 2 ']","['anastomosis gastric bypass (OAGB', 'OAGB with fixed bypass of the proximal 200\xa0cm of small bowel and tailored bypass of the proximal 1/3 of bowel', 'One-anastomosis gastric bypass (OAGB) with fixed bypass of the proximal two meters versus tailored bypass of the proximal one-third of small bowel: short-term outcomes']","['weight loss', 'complication rate', 'excess weight loss and total weight loss', 'weight loss, improvement in comorbidities, complications, and changes in nutritional parameters', 'comorbidities', 'serum albumin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}]",80.0,0.0192076,"Both groups were associated with similar changes in the nutritional parameters at 12 months postoperatively, except for the higher serum albumin levels after the tailored bypass than the fixed bypass.
","[{'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Abdallah', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Elgomhuoria Street, Mansoura, Egypt.'}, {'ForeName': 'Sameh Hany', 'Initials': 'SH', 'LastName': 'Emile', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Elgomhuoria Street, Mansoura, Egypt. Sameh200@hotmail.com.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Zakaria', 'Affiliation': 'General Surgery Department, Ain Shams University Hospitals, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Fikry', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Elgomhuoria Street, Mansoura, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elghandour', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Elgomhuoria Street, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'AbdelMawla', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Elgomhuoria Street, Mansoura, Egypt.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Rady', 'Affiliation': 'General Surgery Department, Mansoura General Hospital, Mansoura, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Abdelnaby', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Elgomhuoria Street, Mansoura, Egypt.'}]",Surgical endoscopy,['10.1007/s00464-020-08284-y']
347,33476237,Impact of a Family Economic Intervention (Bridges) on Health Functioning of Adolescents Orphaned by HIV/AIDS: A 5-Year (2012-2017) Cluster Randomized Controlled Trial in Uganda.,"Objectives.  To investigate the long-term impacts of a family economic intervention on physical, mental, and sexual health of adolescents orphaned by AIDS in Uganda. Methods.  Students in grades 5 and 6 from 48 primary schools in Uganda were randomly assigned at the school level (cluster randomization) to 1 of 3 conditions: (1) control (n = 487; 16 schools), (2) Bridges (1:1 savings match rate; n = 396; 16 schools), or (3) Bridges PLUS (2:1 savings match rate; n = 500; 16 schools). Results.  At 24 months, compared with participants in the control condition, Bridges and Bridges PLUS participants reported higher physical health scores, lower depressive symptoms, and higher self-concept and self-efficacy. During the same period, Bridges participants reported lower sexual risk-taking intentions compared with the other 2 study conditions. At 48 months, Bridges and Bridges PLUS participants reported better self-rated health, higher savings, and lower food insecurity. During the same period, Bridges PLUS participants reported reduced hopelessness, and greater self-concept and self-efficacy. At 24 and 48 months, Bridges PLUS participants reported higher savings than Bridges participants. Conclusions.  Economic interventions targeting families raising adolescents orphaned by AIDS can contribute to long-term positive health and overall well-being of these families. Trial Registration.  ClinicalTrials.gov registration no. NCT01447615.",2021,"At 24 months, compared with participants in the control condition, Bridges and Bridges PLUS participants reported higher physical health scores, lower depressive symptoms, and higher self-concept and self-efficacy.","['Students in grades 5 and 6 from 48 primary schools in Uganda', 'Adolescents Orphaned by HIV/AIDS', 'adolescents orphaned by AIDS in Uganda', 'A 5-Year (2012-2017) Cluster Randomized Controlled Trial in Uganda']","['Family Economic Intervention (Bridges', 'family economic intervention']","['self-rated health, higher savings, and lower food insecurity', 'physical health scores, lower depressive symptoms, and higher self-concept and self-efficacy', 'reduced hopelessness, and greater self-concept and self-efficacy', 'sexual risk-taking intentions']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0242299', 'cui_str': 'Orphan'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.126811,"At 24 months, compared with participants in the control condition, Bridges and Bridges PLUS participants reported higher physical health scores, lower depressive symptoms, and higher self-concept and self-efficacy.","[{'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Fred M. Ssewamala, Rachel Brathwaite, and Sicong Sun are with Brown School and the International Center for Child Health and Development, Washington University in St Louis, St Louis, MO. Julia Shu-Huah Wang is with the University of Hong Kong, Department of Social Work and Social Administration, Hong Kong. Larissa Jennings Mayo-Wilson is with Indiana University, School of Public Health, Department of Applied Health Science, Bloomington, IN. Torsten B. Neilands is with the Division of Prevention Science, University of California, San Francisco. Jeanne Brooks-Gunn is with Teachers College and Vagelos College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shu-Huah Wang', 'Affiliation': 'Fred M. Ssewamala, Rachel Brathwaite, and Sicong Sun are with Brown School and the International Center for Child Health and Development, Washington University in St Louis, St Louis, MO. Julia Shu-Huah Wang is with the University of Hong Kong, Department of Social Work and Social Administration, Hong Kong. Larissa Jennings Mayo-Wilson is with Indiana University, School of Public Health, Department of Applied Health Science, Bloomington, IN. Torsten B. Neilands is with the Division of Prevention Science, University of California, San Francisco. Jeanne Brooks-Gunn is with Teachers College and Vagelos College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Brathwaite', 'Affiliation': 'Fred M. Ssewamala, Rachel Brathwaite, and Sicong Sun are with Brown School and the International Center for Child Health and Development, Washington University in St Louis, St Louis, MO. Julia Shu-Huah Wang is with the University of Hong Kong, Department of Social Work and Social Administration, Hong Kong. Larissa Jennings Mayo-Wilson is with Indiana University, School of Public Health, Department of Applied Health Science, Bloomington, IN. Torsten B. Neilands is with the Division of Prevention Science, University of California, San Francisco. Jeanne Brooks-Gunn is with Teachers College and Vagelos College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Sicong', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Fred M. Ssewamala, Rachel Brathwaite, and Sicong Sun are with Brown School and the International Center for Child Health and Development, Washington University in St Louis, St Louis, MO. Julia Shu-Huah Wang is with the University of Hong Kong, Department of Social Work and Social Administration, Hong Kong. Larissa Jennings Mayo-Wilson is with Indiana University, School of Public Health, Department of Applied Health Science, Bloomington, IN. Torsten B. Neilands is with the Division of Prevention Science, University of California, San Francisco. Jeanne Brooks-Gunn is with Teachers College and Vagelos College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Larissa Jennings', 'Initials': 'LJ', 'LastName': 'Mayo-Wilson', 'Affiliation': 'Fred M. Ssewamala, Rachel Brathwaite, and Sicong Sun are with Brown School and the International Center for Child Health and Development, Washington University in St Louis, St Louis, MO. Julia Shu-Huah Wang is with the University of Hong Kong, Department of Social Work and Social Administration, Hong Kong. Larissa Jennings Mayo-Wilson is with Indiana University, School of Public Health, Department of Applied Health Science, Bloomington, IN. Torsten B. Neilands is with the Division of Prevention Science, University of California, San Francisco. Jeanne Brooks-Gunn is with Teachers College and Vagelos College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Fred M. Ssewamala, Rachel Brathwaite, and Sicong Sun are with Brown School and the International Center for Child Health and Development, Washington University in St Louis, St Louis, MO. Julia Shu-Huah Wang is with the University of Hong Kong, Department of Social Work and Social Administration, Hong Kong. Larissa Jennings Mayo-Wilson is with Indiana University, School of Public Health, Department of Applied Health Science, Bloomington, IN. Torsten B. Neilands is with the Division of Prevention Science, University of California, San Francisco. Jeanne Brooks-Gunn is with Teachers College and Vagelos College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Brooks-Gunn', 'Affiliation': 'Fred M. Ssewamala, Rachel Brathwaite, and Sicong Sun are with Brown School and the International Center for Child Health and Development, Washington University in St Louis, St Louis, MO. Julia Shu-Huah Wang is with the University of Hong Kong, Department of Social Work and Social Administration, Hong Kong. Larissa Jennings Mayo-Wilson is with Indiana University, School of Public Health, Department of Applied Health Science, Bloomington, IN. Torsten B. Neilands is with the Division of Prevention Science, University of California, San Francisco. Jeanne Brooks-Gunn is with Teachers College and Vagelos College of Physicians and Surgeons, Columbia University, New York, NY.'}]",American journal of public health,['10.2105/AJPH.2020.306044']
348,33475701,Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial.,"Importance


Coronavirus disease 2019 (COVID-19) continues to spread rapidly worldwide. Neutralizing antibodies are a potential treatment for COVID-19.
Objective


To determine the effect of bamlanivimab monotherapy and combination therapy with bamlanivimab and etesevimab on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in mild to moderate COVID-19.
Design, Setting, and Participants


The BLAZE-1 study is a randomized phase 2/3 trial at 49 US centers including ambulatory patients (N = 613) who tested positive for SARS-CoV-2 infection and had 1 or more mild to moderate symptoms. Patients who received bamlanivimab monotherapy or placebo were enrolled first (June 17-August 21, 2020) followed by patients who received bamlanivimab and etesevimab or placebo (August 22-September 3). These are the final analyses and represent findings through October 6, 2020.
Interventions


Patients were randomized to receive a single infusion of bamlanivimab (700 mg [n = 101], 2800 mg [n = 107], or 7000 mg [n = 101]), the combination treatment (2800 mg of bamlanivimab and 2800 mg of etesevimab [n = 112]), or placebo (n = 156).
Main Outcomes and Measures


The primary end point was change in SARS-CoV-2 log viral load at day 11 (±4 days). Nine prespecified secondary outcome measures were evaluated with comparisons between each treatment group and placebo, and included 3 other measures of viral load, 5 on symptoms, and 1 measure of clinical outcome (the proportion of patients with a COVID-19-related hospitalization, an emergency department [ED] visit, or death at day 29).
Results


Among the 577 patients who were randomized and received an infusion (mean age, 44.7 [SD, 15.7] years; 315 [54.6%] women), 533 (92.4%) completed the efficacy evaluation period (day 29). The change in log viral load from baseline at day 11 was -3.72 for 700 mg, -4.08 for 2800 mg, -3.49 for 7000 mg, -4.37 for combination treatment, and -3.80 for placebo. Compared with placebo, the differences in the change in log viral load at day 11 were 0.09 (95% CI, -0.35 to 0.52; P = .69) for 700 mg, -0.27 (95% CI, -0.71 to 0.16; P = .21) for 2800 mg, 0.31 (95% CI, -0.13 to 0.76; P = .16) for 7000 mg, and -0.57 (95% CI, -1.00 to -0.14; P = .01) for combination treatment. Among the secondary outcome measures, differences between each treatment group vs the placebo group were statistically significant for 10 of 84 end points. The proportion of patients with COVID-19-related hospitalizations or ED visits was 5.8% (9 events) for placebo, 1.0% (1 event) for 700 mg, 1.9% (2 events) for 2800 mg, 2.0% (2 events) for 7000 mg, and 0.9% (1 event) for combination treatment. Immediate hypersensitivity reactions were reported in 9 patients (6 bamlanivimab, 2 combination treatment, and 1 placebo). No deaths occurred during the study treatment.
Conclusions and Relevance


Among nonhospitalized patients with mild to moderate COVID-19 illness, treatment with bamlanivimab and etesevimab, compared with placebo, was associated with a statistically significant reduction in SARS-CoV-2 viral load at day 11; no significant difference in viral load reduction was observed for bamlanivimab monotherapy. Further ongoing clinical trials will focus on assessing the clinical benefit of antispike neutralizing antibodies in patients with COVID-19 as a primary end point.
Trial Registration


ClinicalTrials.gov Identifier: NCT04427501.",2021,"Compared with placebo, the differences in the change in log viral load at day 11 were 0.09 (95% CI, -0.35 to 0.52; P = .69) for 700 mg, -0.27 (95% CI, -0.71 to 0.16; P = .21) for 2800 mg, 0.31 (95% CI, -0.13 to 0.76; P = .16) for 7000 mg, and -0.57 (95% CI, -1.00 to -0.14; P = .01) for combination treatment.","['Patients', 'patients with COVID-19 as a primary end point', '577 patients who were randomized and received an infusion (mean age, 44.7 [SD, 15.7] years; 315 [54.6%] women), 533 (92.4%) completed the efficacy evaluation period (day 29', 'mild to moderate COVID-19', '49 US centers including ambulatory patients (N\u2009=\u2009613) who tested positive for SARS-CoV-2 infection and had 1 or more mild to moderate symptoms']","['placebo', 'combination treatment (2800 mg of bamlanivimab and 2800 mg of etesevimab [n\u2009=\u2009112]), or placebo', 'Bamlanivimab', 'bamlanivimab monotherapy or placebo', 'bamlanivimab monotherapy and combination therapy with bamlanivimab and etesevimab', 'bamlanivimab', 'bamlanivimab and etesevimab or placebo']","['log viral load', 'viral load reduction', 'viral load, 5 on symptoms, and 1 measure of clinical outcome (the proportion of patients with a COVID-19-related hospitalization, an emergency department [ED] visit, or death at day 29', 'Immediate hypersensitivity reactions', 'SARS-CoV-2 viral load', 'change in SARS-CoV-2 log viral load', 'deaths', 'proportion of patients with COVID-19-related hospitalizations or ED visits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517680', 'cui_str': '2800'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020523', 'cui_str': 'IgE-mediated allergic disorder'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.45133,"Compared with placebo, the differences in the change in log viral load at day 11 were 0.09 (95% CI, -0.35 to 0.52; P = .69) for 700 mg, -0.27 (95% CI, -0.71 to 0.16; P = .21) for 2800 mg, 0.31 (95% CI, -0.13 to 0.76; P = .16) for 7000 mg, and -0.57 (95% CI, -1.00 to -0.14; P = .01) for combination treatment.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': 'Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas, Texas.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nirula', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles, California.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Boscia', 'Affiliation': 'Vitalink Research, Union, South Carolina.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Heller', 'Affiliation': 'Long Beach Clinical Trials, Long Beach, California.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': 'Imperial Health, Lake Charles, Louisiana.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Huhn', 'Affiliation': 'Cook County Health, Chicago, Illinois.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cardona', 'Affiliation': 'Indago Research, Hialeah, Florida.'}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Mocherla', 'Affiliation': 'Las Vegas Medical Research Center, Las Vegas, Nevada.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Stosor', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Shawa', 'Affiliation': 'Franciscan Health, Greenwood, Indiana.'}, {'ForeName': 'Princy', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Georgetown University, Washington, DC.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Adams', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Van Naarden', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Custer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Durante', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Oakley', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Schade', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Holzer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Ebert', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Higgs', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Kallewaard', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Sabo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Dipak R', 'Initials': 'DR', 'LastName': 'Patel', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Skovronsky', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}]",JAMA,['10.1001/jama.2021.0202']
349,33502809,Differential impact of abluminal groove-filled biodegradable-polymer sirolimus-eluting stent versus durable-polymer everolimus-eluting stent on and off dual antiplatelet therapy.,"BACKGROUND


Current guidelines recommend dual antiplatelet therapy (DAPT) following percutaneous coronary intervention for 6-12 months in patients with acute coronary syndrome (ACS) and 3-6 months in those with chronic coronary syndromes (CCS). Whether DAPT duration has a differential effect on outcomes following treatment of ischemic coronary disease with durable versus biodegradable drug-eluting stent (DES) is poorly defined.
METHODS


The TARGET All Comer study was a randomized trial of patients with ischemic coronary artery disease assigned to treatment with either a biodegradable polymer DES (Firehawk) or a durable polymer DES (XIENCE). This pre-specified TARGET AC sub-analysis sought to evaluate the 2-year clinical outcomes before and after DAPT discontinuation. The primary endpoint was target lesion failure (TLF).
RESULTS


A total of 1,296 (78.4%) of 1,653 randomized patients were included in this substudy, of which 1,210 (93.4%) remained on DAPT at 6 months, 863 (66.6%) at 12 months, and 409 (31.6%) at 2 years. There was no difference in TLF between patients treated with Firehawk and XIENCE stents from index procedure to DAPT discontinuation (8.0 and 7.7%, p > .99) or after DAPT discontinuation (2.9 vs. 3.8%, p = .16). After DAPT discontinuation, target vessel myocardial infarction (1.3 vs. 3.3%, p = .07), and ischemia-driven target lesion revascularization (0.5 vs. 1.9%, p = .06) favored treatment with Firehawk.
CONCLUSIONS


Although TLF was comparable for both Firehawk and XIENCE stent groups before and after DAPT discontinuation, after DAPT discontinuation, there was a trend for less target vessel myocardial infarction and ischemia-driven revascularization with the biodegradable polymer DES.",2022,"After DAPT discontinuation, target vessel myocardial infarction (1.3 vs. 3.3%, p = .07), and ischemia-driven target lesion revascularization (0.5 vs. 1.9%, p = .06) favored treatment with Firehawk.
","['A total of 1,296 (78.4%) of 1,653 randomized patients were included in this substudy, of which 1,210 (93.4%) remained on DAPT at 6 months, 863 (66.6%) at 12\u2009months, and 409 (31.6%) at 2\u2009years', 'patients with acute coronary syndrome (ACS) and 3-6 months in those with chronic coronary syndromes (CCS', 'patients with ischemic coronary artery disease assigned to treatment with either a']","['TLF', 'abluminal groove-filled biodegradable-polymer sirolimus-eluting stent versus durable-polymer everolimus-eluting stent', 'percutaneous coronary intervention', 'DAPT', 'biodegradable polymer DES (Firehawk) or a durable polymer DES (XIENCE', 'biodegradable drug-eluting stent (DES', 'dual antiplatelet therapy (DAPT']","['target vessel myocardial infarction', 'target vessel myocardial infarction and ischemia-driven revascularization', 'target lesion failure (TLF', 'TLF', 'ischemia-driven target lesion revascularization']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",1653.0,0.0497583,"After DAPT discontinuation, target vessel myocardial infarction (1.3 vs. 3.3%, p = .07), and ischemia-driven target lesion revascularization (0.5 vs. 1.9%, p = .06) favored treatment with Firehawk.
","[{'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Baumbach', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Fu Wai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbaek', 'Affiliation': 'Department of Cardiology, Roskilde University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Shanghai MicroPort Medical (Group) Co., Ltd., Shanghai, China.'}, {'ForeName': 'Marie-Angèle', 'Initials': 'MA', 'LastName': 'Morel', 'Affiliation': 'Cardialysis, Rotterdam, The Netherlands.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'Department of Cardiology, University Hospital of Wales, Heath Park, Cardiff, UK.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Schächinger', 'Affiliation': 'Medizinische Klinik I, Herz-Thorax Zentrum, Klinikum Fulda, Fulda, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Lansky', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29468']
350,33503496,A randomized trial of physical activity for cognitive functioning in breast cancer survivors: Rationale and study design of I Can! Improving Cognition After Cancer.,"INTRODUCTION


Difficulties with cognition are extremely common among breast cancer survivors and can significantly impact quality of life, daily functioning, and ability to return to work. One promising intervention is increasing physical activity, as it has been effective in improving cognition in non-cancer populations. Few physical activity intervention trials with cognition outcomes have included cancer survivors. This project builds upon our previous work indicating that increased physical activity can improve objectively measured processing speed and self-reported cognition among breast cancer survivors.
METHODS


The I Can! study will examine whether a physical activity intervention improves cognition among 250 post-treatment breast cancer survivors (Stages I-III, <5 years post-treatment) who are reporting cognitive difficulties. This 2-arm randomized controlled trial comparing a 6-month physical activity intervention (Exercise Group) to a health & wellness attention-comparison condition (Health & Wellness Group) will examine intervention effects on cognition (at 3 and 6 months) and maintenance of effects at 12 months. The primary aim is to investigate the impact of exercise on objectively measured processing speed and self-reported cognition. Secondary aims are to investigate maintenance of cognitive changes and examine candidate biological mechanisms and psychological mediators.
CONCLUSION


The I Can! study will contribute to the scientific, public health, and survivorship intervention literature by providing new information on the impact of physical activity for cognitive impairment in breast cancer survivors. Findings from this study will inform guidelines for physical activity to improve the lives of millions of breast cancer survivors.",2021,This 2-arm randomized controlled trial comparing a 6-month physical activity intervention (Exercise Group) to a health & wellness attention-comparison condition (Health & Wellness Group) will examine intervention effects on cognition (at 3 and 6 months) and maintenance of effects at 12 months.,"['250 post-treatment breast cancer survivors (Stages I-III, <5\u202fyears post-treatment) who are reporting cognitive difficulties', 'breast cancer survivors']","['physical activity intervention', 'physical activity', 'physical activity intervention (Exercise Group) to a health & wellness attention-comparison condition (Health & Wellness Group']",[],"[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],,0.0294257,This 2-arm randomized controlled trial comparing a 6-month physical activity intervention (Exercise Group) to a health & wellness attention-comparison condition (Health & Wellness Group) will examine intervention effects on cognition (at 3 and 6 months) and maintenance of effects at 12 months.,"[{'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, UC San Diego, La Jolla, CA, USA; UC San Diego Moores Cancer Center, UC San Diego, La Jolla, CA, USA. Electronic address: sjhartman@ucsd.edu.'}, {'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Weiner', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, UC San Diego, La Jolla, CA, USA; UC San Diego Moores Cancer Center, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Loki', 'Initials': 'L', 'LastName': 'Natarajan', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, UC San Diego, La Jolla, CA, USA; UC San Diego Moores Cancer Center, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Dorothy D', 'Initials': 'DD', 'LastName': 'Sears', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, UC San Diego, La Jolla, CA, USA; UC San Diego Moores Cancer Center, UC San Diego, La Jolla, CA, USA; Department of Medicine, UC San Diego, La Jolla, CA, USA; College of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Barton W', 'Initials': 'BW', 'LastName': 'Palmer', 'Affiliation': 'Department of Psychiatry, UC San Diego, La Jolla, CA, USA; Veterans Affairs San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Parker', 'Affiliation': 'UC San Diego Moores Cancer Center, UC San Diego, La Jolla, CA, USA; Department of Medicine, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ahles', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Irwin', 'Affiliation': 'Department of Chronic Disease Epidemiology, Yale School of Public Health, USA.'}, {'ForeName': 'Kaylene', 'Initials': 'K', 'LastName': 'Au', 'Affiliation': 'UC San Diego Moores Cancer Center, UC San Diego, La Jolla, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106289']
351,33512629,Underbody blankets have a higher heating effect than overbody blankets in lithotomy position endoscopic surgery under general anesthesia: a randomized trial.,"BACKGROUND


Surgery under general anesthesia results in temperature decrease due to the effect of anesthetics and peripheral vasodilation on thermoregulatory centers. Perioperative temperature control is therefore an issue of high importance. In this study, we aimed to compare the warming effect of underbody and overbody blankets in patients undergoing surgery in the lithotomy position under general anesthesia.
METHODS


From September 2018 to October 2019, 99 patients undergoing surgery for colorectal cancer in the lithotomy position were included in this randomized controlled trial and assigned to the intervention group (underbody blanket) or control group (overbody blanket).
RESULTS


The central temperature was significantly higher in the underbody blanket group than in the overbody blanket group at 90 min after the beginning of the surgery (p = 0.02); also in this group, the peripheral temperature was significantly higher 60 min after the beginning of the surgery (p = 0.02). Regarding postoperative factors, the underbody blanket group had a significantly lower frequency of postoperative shivering (p < 0.01) and a significantly shorter postoperative hospital stay (p = 0.04) than the overbody blanket group.
CONCLUSIONS


We recommend the use of underbody blankets for intraoperative temperature control in patients undergoing surgery in the lithotomy position under general anesthesia. Underbody blankets showed improved rise and maintenance of central and peripheral temperature, decreased the incidence of postoperative shivering, and shortened the postoperative length of hospital stay.",2022,"Underbody blankets showed improved rise and maintenance of central and peripheral temperature, decreased the incidence of postoperative shivering, and shortened the postoperative length of hospital stay.","['patients undergoing surgery in the lithotomy position under general anesthesia', 'lithotomy position endoscopic surgery under general anesthesia', 'From September 2018 to October 2019, 99 patients undergoing surgery for colorectal cancer in the lithotomy position']","['Underbody blankets', 'overbody blankets', 'underbody and overbody blankets', 'underbody blankets', 'intervention group (underbody blanket) or control group (overbody blanket']","['rise and maintenance of central and peripheral temperature', 'frequency of postoperative shivering', 'postoperative length of hospital stay', 'incidence of postoperative shivering', 'peripheral temperature', 'central temperature', 'postoperative hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0150665', 'cui_str': 'Lithotomy position'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0179330', 'cui_str': 'Blanket'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1736186', 'cui_str': 'Postoperative shivering'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",99.0,0.0822903,"Underbody blankets showed improved rise and maintenance of central and peripheral temperature, decreased the incidence of postoperative shivering, and shortened the postoperative length of hospital stay.","[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Hara', 'Affiliation': 'Department of Operation Center, National Hospital Organization Nagasaki Medical Center, Kubara 2-1001-1, Omura, Nagasaki, 856-8562, Japan. hara.kentaro.yu@mail.hosp.go.jp.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Kuroda', 'Affiliation': 'Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, 852-8523, Japan.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Matsuura', 'Affiliation': 'Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, 852-8523, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ishimatsu', 'Affiliation': 'Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, 852-8523, Japan.'}, {'ForeName': 'Sumihisa', 'Initials': 'S', 'LastName': 'Honda', 'Affiliation': 'Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, 852-8523, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Takeshita', 'Affiliation': 'Department of Surgery, National Hospital Organization Nagasaki Medical Center, Nagasaki, 856-8562, Japan.'}, {'ForeName': 'Terumitsu', 'Initials': 'T', 'LastName': 'Sawai', 'Affiliation': 'Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, 852-8523, Japan.'}]",Surgical endoscopy,['10.1007/s00464-021-08335-y']
352,33470769,Sleep quality and cortical amyloid-β deposition in postmenopausal women of the Kronos early estrogen prevention study.,"Hormone therapy improves sleep in menopausal women and recent data suggest that transdermal 17β-estradiol may reduce the accumulation of cortical amyloid-β. However, how menopausal hormone therapies modify the associations of amyloid-β accumulation with sleep quality is not known. In this study, associations of sleep quality with cortical amyloid-β deposition and cognitive function were assessed in a subset of women who had participated in the Kronos early estrogen prevention study. It was a randomized, placebo-controlled trial in which recently menopausal women (age, 42-58; 5-36 months past menopause) were randomized to (1) oral conjugated equine estrogen (n = 19); (2) transdermal 17β-estradiol (tE2, n = 21); (3) placebo pills and patch (n = 32) for 4 years. Global sleep quality score was calculated using Pittsburgh sleep quality index, cortical amyloid-β deposition was measured with Pittsburgh compound-B positron emission tomography standard uptake value ratio and cognitive function was assessed in four cognitive domains 3 years after completion of trial treatments. Lower global sleep quality score (i.e., better sleep quality) correlated with lower cortical Pittsburgh compound-B standard uptake value ratio only in the tE2 group (r = 0.45, P = 0.047). Better global sleep quality also correlated with higher visual attention and executive function scores in the tE2 group (r = -0.54, P = 0.02) and in the oral conjugated equine estrogen group (r = -0.65, P = 0.005). Menopausal hormone therapies may influence the effects of sleep on cognitive function, specifically, visual attention and executive function. There also appears to be a complex relationship between sleep, menopausal hormone therapies, cortical amyloid-β accumulation and cognitive function, and tE2 formulation may modify the relationship between sleep and amyloid-β accumulation.",2021,"Lower global sleep quality score (i.e., better sleep quality) correlated with lower cortical Pittsburgh compound-B standard uptake value ratio only in the tE2 group (r = 0.45, P = 0.047).","['recently menopausal women (age, 42-58; 5-36 months past menopause', 'women who had participated in the Kronos early estrogen prevention study', 'postmenopausal women of the Kronos early estrogen prevention study', 'menopausal women']","['placebo', 'placebo pills and patch', 'Hormone therapy', 'transdermal 17β-estradiol', 'Menopausal hormone therapies', 'oral conjugated equine estrogen']","['Sleep quality and cortical amyloid-β deposition', 'visual attention and executive function scores', 'Pittsburgh sleep quality index, cortical amyloid-β deposition', 'Lower global sleep quality score', 'Better global sleep quality', 'Global sleep quality score']","[{'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.131108,"Lower global sleep quality score (i.e., better sleep quality) correlated with lower cortical Pittsburgh compound-B standard uptake value ratio only in the tE2 group (r = 0.45, P = 0.047).","[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Zeydan', 'Affiliation': 'Department of Radiology.'}, {'ForeName': 'Val J', 'Initials': 'VJ', 'LastName': 'Lowe', 'Affiliation': 'Department of Radiology.'}, {'ForeName': 'Nirubol', 'Initials': 'N', 'LastName': 'Tosakulwong', 'Affiliation': 'Department of Health Sciences Research.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Lesnick', 'Affiliation': 'Department of Health Sciences Research.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Senjem', 'Affiliation': 'Department of Radiology.'}, {'ForeName': 'Clifford R', 'Initials': 'CR', 'LastName': 'Jack', 'Affiliation': 'Department of Radiology.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Fields', 'Affiliation': 'Department of Psychiatry, Mayo Clinic Rochester, Minnesota.'}, {'ForeName': 'Taryn T', 'Initials': 'TT', 'LastName': 'James', 'Affiliation': 'Division of Geriatrics, Department of Medicine, School of Medicine and Public Health.'}, {'ForeName': 'Carey E', 'Initials': 'CE', 'LastName': 'Gleason', 'Affiliation': 'Division of Geriatrics, Department of Medicine, School of Medicine and Public Health.'}, {'ForeName': 'N Maritza', 'Initials': 'NM', 'LastName': 'Dowling', 'Affiliation': 'Department of Acute & Chronic Care, School of Nursing, Department of Epidemiology & Biostatistics, Milken Institute School of Public Health, The George Washington University, Washington, DC.'}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Miller', 'Affiliation': 'Department of Physiology and Biomedical Engineering.'}, {'ForeName': 'Kejal', 'Initials': 'K', 'LastName': 'Kantarci', 'Affiliation': 'Department of Radiology.'}]",Neuroreport,['10.1097/WNR.0000000000001592']
353,33477158,Effect of Argatroban Injection on Clinical Efficacy in Patients with Acute Cerebral Infarction: Preliminary Findings.,"OBJECTIVE


The aim is to observe the effects of argatroban injection and butylphthalide injection on blood flow rheology, clinical efficacy, and safety in patients with acute cerebral infarction.
METHODS


344 patients with acute cerebral infarction within 48 h after admission were divided into treatment group and control group, with 172 cases in each group. The control group received routine treatment. The treatment group received argatroban injection 60 mg on the basis of the control group, intravenously guttae (ivgtt) was used for 2 days and then changed to argatroban injection 10 mg, ivgtt bid for 5 days, and the total course of treatment was 7 days. The neurological changes, activities of daily living, and the rheology indicators (fibrinogen [Fib], platelet aggregation rate [Pag], whole blood high shear viscosity [Whsv], hematocrit [Hct]) were compared between the 2 groups, clinical efficacy and adverse drug reactions.
RESULTS


After treatment, the total effective rates of the treatment group and the control group were 90.70% (156 /172 cases) and 74.41% (128 and 172 cases), respectively, and the difference was statistically significant (p < 0.05). After treatment, the National Institutes of Health Stroke Scale scores of the treatment group and the control group were (7.05 ± 1.97) and (8.30 ± 1.79), respectively, and the Barthel index was (68.02 ± 11.07) and (62.32 ± 11.46), respectively. The difference was statistically significant (p < 0.05). After treatment, the treatment group and the control group were (2.66 ± 0.22) g/L and (3.50 ± 0.22) g/L, respectively, and Pag were (0.68 ± 0.06)% and (0.81 ± 0.09)%, respectively, and Whsv was (6.44 ± 0.76) mPs/s and (6.87 ± 0.91) mPs/s, Hct were (8.19 ± 1.21)% and (10.44 ± 1.04)%, respectively, and the differences were statistically significant (p < 0.05). The incidence of adverse reactions in the treatment group and the control group was 6.97 and 5.81%, respectively, and the difference was not statistically significant (p > 0.05).
CONCLUSION


Argatroban injection is effective in the treatment of acute cerebral infarction, which can significantly improve the hemorheology of patients with good safety.",2021,"The neurological changes, activities of daily living, and the rheology indicators (fibrinogen [Fib], platelet aggregation rate [Pag], whole blood high shear viscosity [Whsv], hematocrit [Hct]) were compared between the 2 groups, clinical efficacy and adverse drug reactions.
","['Patients with Acute Cerebral Infarction', '344 patients with acute cerebral infarction within 48 h after admission', 'patients with acute cerebral infarction']","['argatroban injection and butylphthalide injection', 'Argatroban Injection', 'argatroban injection', 'Argatroban injection', 'routine treatment']","['clinical efficacy and adverse drug reactions', 'Clinical Efficacy', 'blood flow rheology, clinical efficacy, and safety', 'total effective rates', 'incidence of adverse reactions', 'Health Stroke Scale scores', 'neurological changes, activities of daily living, and the rheology indicators (fibrinogen [Fib], platelet aggregation rate [Pag], whole blood high shear viscosity [Whsv], hematocrit [Hct']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C4255162', 'cui_str': 'argatroban Injection'}, {'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0035423', 'cui_str': 'Rheology'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}]",344.0,0.0286194,"The neurological changes, activities of daily living, and the rheology indicators (fibrinogen [Fib], platelet aggregation rate [Pag], whole blood high shear viscosity [Whsv], hematocrit [Hct]) were compared between the 2 groups, clinical efficacy and adverse drug reactions.
","[{'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': ""Department of Neurology, People's Hospital of Deyang City, DeYang, China.""}, {'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'He', 'Affiliation': 'Department of Neurology, The Affiliated Hospital of Southwest Medical University, LuZhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Deyang City, DeYang, China, 782067723@qq.com.""}]",European neurology,['10.1159/000512813']
354,33502615,Digital approach to informed consent in bariatric surgery: a randomized controlled trial.,"BACKGROUND


Informed consent is of paramount importance in surgery. Digital media can be used to enhance patient's comprehension of the proposed operation. The objective of this study was to examine the effects of adding a digital educational platform (DEP) to a standard verbal consent (SVC) for a laparoscopic Roux-en-Y gastric bypass (LRYGB) on patient's knowledge of the procedure, satisfaction with the clinical encounter and duration of the consent appointment.
METHODS


This prospective non-blinded randomized controlled trial allocated 51 patients, who were candidates for a LRYGB, into DEP+SVC (intervention, n = 26) or SVC (control, n = 25) groups. Data were collected at one Bariatric Centre of Excellence (Ontario, Canada) between December 2018 and December 2019. DEP consisted of a 29-slide video-supplemented module detailing the risks, benefits, expectations and outcomes for the LRYGB. Primary outcome was knowledge about the LRYGB operation following the consent discussion. Secondary outcomes were knowledge retention, patient satisfaction, and duration of time required to obtain an informed consent.
RESULTS


Baseline demographic data were equivalent between groups except for a greater proportion of male patients in the DEP+SVC group (7/19 vs 0/25; p < 0.01). Baseline procedure-specific knowledge was equivalent between the groups (72.3 ± 11.3% vs 74.7 ± 9.6%; p = 0.41). Post-consent knowledge was significantly higher in the DEP + SVC vs SVC group (85.0 ± 8.8% vs 78.7 ± 8.7%; p = 0.01; ES = 0.72). The duration of time to obtain informed consent was significantly shorter for the DEP + SVC vs SVC group (358 ± 198 sec vs 751 ± 212 sec; p < 0.01; ES = 1.92). There was no difference in knowledge retention at 4-6 weeks (84.4 ± 10.2% vs 82.9 ± 6.8%; p = 0.55) and in patient satisfaction (31.5 ± 1.1 vs 31 ± 2.7; p = 0.10).
CONCLUSION


The addition of a DEP online module to a standard verbal consent for LRYGB resulted in improved patient's understanding of the procedure-specific risks and benefits, high patient satisfaction, and over 50% time savings for the bariatric surgeon conducting the consent discussion.",2022,"RESULTS


Baseline demographic data were equivalent between groups except for a greater proportion of male patients in the DEP+SVC group (7/19 vs 0/25; p < 0.01).","['51 patients, who were candidates for a LRYGB, into DEP+SVC (intervention, n\u2009=\u200926) or SVC (control, n\u2009=\u200925) groups', 'bariatric surgery']","['laparoscopic Roux-en-Y gastric bypass (LRYGB', 'digital educational platform (DEP', 'DEP+SVC', 'standard verbal consent (SVC']","['Baseline procedure-specific knowledge', 'duration of time to obtain informed consent', 'knowledge retention, patient satisfaction, and duration of time required to obtain an informed consent', 'patient satisfaction', 'knowledge retention', 'Post-consent knowledge', 'knowledge about the LRYGB operation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",51.0,0.114456,"RESULTS


Baseline demographic data were equivalent between groups except for a greater proportion of male patients in the DEP+SVC group (7/19 vs 0/25; p < 0.01).","[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Zevin', 'Affiliation': ""Department of Surgery, Queen's University, Kingston, Canada. boris.a.zevin@gmail.com.""}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Almakky', 'Affiliation': ""Department of Surgery, Queen's University, Kingston, Canada.""}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Mancini', 'Affiliation': ""Department of Surgery, Queen's University, Kingston, Canada.""}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Robertson', 'Affiliation': ""Department of Surgery, Queen's University, Kingston, Canada.""}]",Surgical endoscopy,['10.1007/s00464-020-08277-x']
355,33515782,A cluster-randomized control trial targeting parents of pediatric cancer survivors with obesity: Rationale and study protocol of NOURISH-T.,"Approximately 40-50% of pediatric cancer survivors (PCS) are overweight or obese; increasing their risk for metabolic syndrome and other negative long-term physical health complications. Using our successful pilot trial testing the preliminary feasibility and efficacy of NOURISH for Healthy Transitions (NOURISH-T), we refined our intervention, now NOURISH-T+, and will implement these refinements in this larger, multi-site randomized control trial. Parents of PCS with overweight/obesity (BMI ≥ 85th%ile), age 5-12, ≥6 months off treatment are randomly assigned to the NOURISH-T+ intervention or Enhanced Usual Care (EUC) comparison. Parents in NOURISH-T+ will participate in a 6-session, manualized intervention, with an additional dietician session and 2 PCS sessions, as well as post-intervention booster sessions. EUC consists of a one-time informational session, nationally available brochures and follow-up check-ins. Both study conditions will be conducted remotely via a videoconferencing platform. Parents and PCS will be assessed on anthropometric measures, physical activity (PA) and dietary behaviors at baseline, 3-, 6-, and 12-months post-intervention. We will enroll a diverse group of 260 parents/PCS dyads from four pediatric oncology clinics with the aim of evaluating the efficacy of our intervention across diverse pediatric oncology clinics. Our main aim is to compare the impact of NOURISH-T+ with EUC on PCS BMI z-score. Secondary aims are to compare intervention impact on PCS PA and eating behaviors and parent BMI and behaviors as well as to explore potential moderators of the intervention. Our longer-term goal is to establish a framework for future translation and dissemination of NOURISH-T+.",2021,"Using our successful pilot trial testing the preliminary feasibility and efficacy of NOURISH for Healthy Transitions (NOURISH-T), we refined our intervention, now NOURISH-T+, and will implement these refinements in this larger, multi-site randomized control trial.","['pediatric cancer survivors with obesity', 'Parents of PCS with overweight/obesity (BMI\u202f≥\u202f85th%ile), age 5-12, ≥6\u202fmonths off treatment', '260 parents/PCS dyads from four pediatric oncology clinics']",['NOURISH-T+ intervention or Enhanced Usual Care (EUC) comparison'],"['PCS BMI z-score', 'anthropometric measures, physical activity (PA) and dietary behaviors', 'PCS PA and eating behaviors and parent BMI and behaviors']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C3816504', 'cui_str': 'Pediatric oncology clinic'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",,0.0564866,"Using our successful pilot trial testing the preliminary feasibility and efficacy of NOURISH for Healthy Transitions (NOURISH-T), we refined our intervention, now NOURISH-T+, and will implement these refinements in this larger, multi-site randomized control trial.","[{'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Stern', 'Affiliation': 'Department of Child and Family Studies, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, United States of America. Electronic address: mstern1@usf.edu.'}, {'ForeName': 'Heewon L', 'Initials': 'HL', 'LastName': 'Gray', 'Affiliation': 'College of Public Health, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Ruble', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, United States of America.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Soca Lozano', 'Affiliation': 'College of Education, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Albizu-Jacob', 'Affiliation': 'Department of Child and Family Studies, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'Department of Child and Family Studies, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Kamar', 'Initials': 'K', 'LastName': 'Godder', 'Affiliation': ""Nicklaus Children's Hospital, Miami, FL, United States of America.""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Fuemmeler', 'Affiliation': 'Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Mazzeo', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106296']
356,33503497,Design and rationale of an intervention to improve cancer prevention using clinical decision support and shared decision making: A clinic-randomized trial.,"BACKGROUND


Despite decades of research the gap in primary and secondary cancer prevention services in the U. S. remains unacceptably wide. Innovative interventions are needed to address this persistent challenge. Electronic health records linked with Web-based clinical decision support may close this gap, especially if delivered to both patients and their providers.
OBJECTIVES


The Cancer Prevention Wizard (CPW) study is an implementation, clinic-randomized trial designed to achieve these aims: 1) assess impact of the Cancer Prevention Wizard-Clinical Decision Support (CPW-CDS) alone and CPW-CDS plus Shared Decision Making Tools (CPW + SDMTs) compared to usual care (UC) on tobacco cessation counseling and drugs, HPV vaccinations, and screening tests for breast, cervical, colorectal, or lung cancer; 2) assess cost of the CPW-CDS intervention; and 3) describe critical facilitators and barriers for CPW-CDS implementation, use, and clinical impact using a mixed-methods approach supported by the CFIR and RE-AIM frameworks.
METHODS


34 predominantly rural, primary care clinics were randomized to CPW-CDS, CPW + SMDTs, or UC. Between August 2018 and October 2020, primary care providers and their patients who met inclusion criteria in intervention clinics were exposed to the CPW-CDS with or without SDMTs. Study outcomes at 12 months post index visit include patients up to date on screening tests and HPV vaccinations, overall healthcare costs, and diagnostic codes and billing levels for cancer prevention services.
CONCLUSIONS


We will test in rural primary care settings whether CPW-CDS with or without SDMTs can improve delivery of primary and secondary cancer prevention services. The trial and analyses are ongoing with results expected in 2021.",2021,"Study outcomes at 12 months post index visit include patients up to date on screening tests and HPV vaccinations, overall healthcare costs, and diagnostic codes and billing levels for cancer prevention services.
","['Between August 2018 and October 2020, primary care providers and their patients who met inclusion criteria in intervention clinics', '34 predominantly rural, primary care clinics']","['Cancer Prevention Wizard-Clinical Decision Support (CPW-CDS) alone and CPW-CDS plus Shared Decision Making Tools (CPW\u202f+\u202fSDMTs', 'CPW-CDS, CPW\u202f+\u202fSMDTs, or UC', 'CPW-CDS with or without SDMTs']","['screening tests and HPV vaccinations, overall healthcare costs, and diagnostic codes and billing levels for cancer prevention services']","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",34.0,0.0519174,"Study outcomes at 12 months post index visit include patients up to date on screening tests and HPV vaccinations, overall healthcare costs, and diagnostic codes and billing levels for cancer prevention services.
","[{'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Elliott', 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: thomas.e.elliott@healthpartners.com.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: Patrick.j.oconnor@healthpartners.com.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Asche', 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: Steve.e.asche@healthpartners.com.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Saman', 'Affiliation': 'Essentia Institute of Rural Health, 502 E. 2nd St., Duluth, MN 55805, USA. Electronic address: Daniel.Saman@essentiahealth.org.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Dehmer', 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: Steven.p.dehmer@healthpartners.com.'}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Ekstrom', 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: Heidi.l.ekstrom@healthpartners.com.'}, {'ForeName': 'Clayton I', 'Initials': 'CI', 'LastName': 'Allen', 'Affiliation': 'Essentia Institute of Rural Health, 502 E. 2nd St., Duluth, MN 55805, USA. Electronic address: Clayton.Allen@essentiahealth.org.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Bianco', 'Affiliation': 'Essentia Health, Duluth, MN, USA. Electronic address: Joseph.Bianco@essentiahealth.org.'}, {'ForeName': 'Ella A', 'Initials': 'EA', 'LastName': 'Chrenka', 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: Ella.a.chrenka@healthpartners.com.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Freitag', 'Affiliation': 'Essentia Institute of Rural Health, 502 E. 2nd St., Duluth, MN 55805, USA. Electronic address: Laura.Freitag@essentiahealth.org.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Harry', 'Affiliation': 'Essentia Institute of Rural Health, 502 E. 2nd St., Duluth, MN 55805, USA. Electronic address: Melissa.Harry@essentiahealth.org.'}, {'ForeName': 'Anjali R', 'Initials': 'AR', 'LastName': 'Truitt', 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: Anjali.r.truitt@healthpartners.com.'}, {'ForeName': 'JoAnn M', 'Initials': 'JM', 'LastName': 'Sperl-Hillen', 'Affiliation': 'HealthPartners Institute, 8170 33rd Ave. South, Minneapolis, MN 55425, USA. Electronic address: Joann.m.sperlhillen@healthpartners.com.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106271']
357,33821937,Mechanisms of Action in a Behavioral Weight-Management Program: Latent Growth Curve Analysis.,"BACKGROUND


A greater understanding of the mechanisms of action of weight-management interventions is needed to inform the design of effective interventions.
PURPOSE


To investigate whether dietary restraint, habit strength, or diet self-regulation mediated the impact of a behavioral weight-management intervention on weight loss and weight loss maintenance.
METHODS


Latent growth curve analysis (LGCA) was conducted on trial data in which adults (N = 1,267) with a body mass index (BMI) ≥28 kg/m2 were randomized to either a brief intervention (booklet on losing weight), a 12 week weight-management program or the same program for 52 weeks. LGCA estimated the trajectory of the variables over four time points (baseline and 3, 12 and 24 months) to assess whether potential mechanisms of action mediated the impact of the weight-management program on BMI.
RESULTS


Participants randomized to the 12 and 52 week programs had a significantly greater decrease in BMI than the brief intervention. This direct effect became nonsignificant when dietary restraint, habit strength, and autonomous diet self-regulation were controlled for. The total indirect effect was significant for both the 12 (estimate = -1.33, standard error [SE] = 0.41, p = .001) and 52 week (estimate = -2.13, SE = 0.52, p < .001) program. Only the individual indirect effect for dietary restraint was significant for the 12 week intervention, whereas all three indirect effects were significant for the 52 week intervention.
CONCLUSIONS


Behavior change techniques that target dietary restraint, habit strength, and autonomous diet self-regulation should be considered when designing weight loss and weight loss maintenance interventions. Longer interventions may need to target both deliberative and automatic control processes to support successful weight management.",2022,"Only the individual indirect effect for dietary restraint was significant for the 12 week intervention, whereas all three indirect effects were significant for the 52 week intervention.
","['Latent growth curve analysis (LGCA) was conducted on trial data in which adults (N = 1,267) with a body mass index (BMI) ≥28 kg/m2', 'a Behavioral Weight-Management Program']","['LGCA', 'behavioral weight-management intervention', 'brief intervention (booklet on losing weight']","['total indirect effect', 'BMI', 'dietary restraint', 'weight loss and weight loss maintenance']","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}]","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",1267.0,0.0077377,"Only the individual indirect effect for dietary restraint was significant for the 12 week intervention, whereas all three indirect effects were significant for the 52 week intervention.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bates', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Norman', 'Affiliation': 'Department of Psychology, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Breeze', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Brennan', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Ahern', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, UK.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaab019']
358,33516964,Heartrate variability biofeedback for migraine using a smartphone application and sensor: A randomized controlled trial.,"INTRODUCTION


Although hand temperature and electromyograph biofeedback have evidence for migraine prevention, to date, no study has evaluated heartrate variability (HRV) biofeedback for migraine.
METHODS


2-arm randomized trial comparing an 8-week app-based HRV biofeedback (HeartMath) to waitlist control. Feasibility/acceptability outcomes included number and duration of sessions, satisfaction, barriers and adverse events. Primary clinical outcome was Migraine-Specific Quality of Life Questionnaire (MSQv2).
RESULTS


There were 52 participants (26/arm). On average, participants randomized to the Hearthmath group completed 29 sessions (SD = 29, range: 2-86) with an average length of 6:43 min over 36 days (SD = 27, range: 0, 88) before discontinuing. 9/29 reported technology barriers. 43% said that they were likely to recommend Heartmath to others. Average MSQv2 decreases were not significant between the Heartmath and waitlist control (estimate = 0.3, 95% CI = -3.1 - 3.6). High users of Heartmath reported a reduction in MSQv2 at day 30 (-12.3 points, p = 0.010) while low users did not (p = 0.765).
DISCUSSION


App-based HRV biofeedback was feasible and acceptable on a time-limited basis for people with migraine. Changes in the primary clinical outcome did not differ between biofeedback and control; however, high users of the app reported more benefit than low users.",2021,"Changes in the primary clinical outcome did not differ between biofeedback and control; however, high users of the app reported more benefit than low users.","['people with migraine', '52 participants (26/arm']","['smartphone application and sensor', 'electromyograph biofeedback', 'App-based HRV biofeedback', '8-week app-based HRV biofeedback (HeartMath) to waitlist control']","['MSQv2', 'Average MSQv2 decreases', 'number and duration of sessions, satisfaction, barriers and adverse events', 'Migraine-Specific Quality of Life Questionnaire (MSQv2']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0180677', 'cui_str': 'Electromyograph'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.159473,"Changes in the primary clinical outcome did not differ between biofeedback and control; however, high users of the app reported more benefit than low users.","[{'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'Department of Neurology, NYU Langone Health, 550 1st Avenue, New York, NY 10016, USA; Department of Population Health, NYU Langone Health, 550 1st Avenue, New York, NY 10016, USA. Electronic address: Minenmd@gmail.com.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Corner', 'Affiliation': 'Department of Neurology, NYU Langone Health, 550 1st Avenue, New York, NY 10016, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berk', 'Affiliation': 'Department of Neurology, NYU Langone Health, 550 1st Avenue, New York, NY 10016, USA.'}, {'ForeName': 'Valeriya', 'Initials': 'V', 'LastName': 'Levitan', 'Affiliation': 'Department of Neurology, NYU Langone Health, 550 1st Avenue, New York, NY 10016, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Friedman', 'Affiliation': 'Department of Population Health, NYU Langone Health, 550 1st Avenue, New York, NY 10016, USA.'}, {'ForeName': 'Samrachana', 'Initials': 'S', 'LastName': 'Adhikari', 'Affiliation': 'Department of Population Health, NYU Langone Health, 550 1st Avenue, New York, NY 10016, USA.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Seng', 'Affiliation': 'Department of Neurology, Yeshiva University Albert Einstein College of Medicine, 1300 Morris Park Ave, The Bronx, NY 10461, United States.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.12.008']
359,33516859,Pinging the brain with transcranial magnetic stimulation reveals cortical reactivity in time and space.,"BACKGROUND


Single-pulse transcranial magnetic stimulation (TMS) elicits an evoked electroencephalography (EEG) potential (TMS-evoked potential, TEP), which is interpreted as direct evidence of cortical reactivity to TMS. Thus, combining TMS with EEG can be used to investigate the mechanism underlying brain network engagement in TMS treatment paradigms. However, controversy remains regarding whether TEP is a genuine marker of TMS-induced cortical reactivity or if it is confounded by responses to peripheral somatosensory and auditory inputs. Resolving this controversy is of great significance for the field and will validate TMS as a tool to probe networks of interest in cognitive and clinical neuroscience.
OBJECTIVE


Here, we delineated the cortical origin of TEP by spatially and temporally localizing successive TEP components, and modulating them with transcranial direct current stimulation (tDCS) to investigate cortical reactivity elicited by single-pulse TMS and its causal relationship with cortical excitability.
METHODS


We recruited 18 healthy participants in a double-blind, cross-over, sham-controlled design. We collected motor-evoked potentials (MEPs) and TEPs elicited by suprathreshold single-pulse TMS targeting the left primary motor cortex (M1). To causally test cortical and corticospinal excitability, we applied tDCS to the left M1.
RESULTS


We found that the earliest TEP component (P25) was localized to the left M1. The following TEP components (N45 and P60) were largely localized to the primary somatosensory cortex, which may reflect afferent input by hand-muscle twitches. The later TEP components (N100, P180, and N280) were largely localized to the auditory cortex. As hypothesized, tDCS selectively modulated cortical and corticospinal excitability by modulating the pre-stimulus mu-rhythm oscillatory power.
CONCLUSION


Together, our findings provide causal evidence that the early TEP components reflect cortical reactivity to TMS.",2021,"The later TEP components (N100, P180, and N280) were largely localized to the auditory cortex.","['18 healthy participants in a double-blind, cross-over, sham-controlled design']","['collected motor-evoked potentials (MEPs) and TEPs elicited by suprathreshold single-pulse TMS', 'Transcranial Magnetic Stimulation', 'TEP', 'transcranial direct current stimulation (tDCS', 'pulse transcranial magnetic stimulation (TMS']",['cortical and corticospinal excitability'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C1564622', 'cui_str': 'Transcranial Magnetic Stimulation, Single Pulse'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",18.0,0.0660331,"The later TEP components (N100, P180, and N280) were largely localized to the auditory cortex.","[{'ForeName': 'Sangtae', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'School of Electronics Engineering, Kyungpook National University, Daegu, 41566, South Korea; School of Electronic and Electrical Engineering, Kyungpook National University, Daegu, 41566, South Korea; Carolina Center for Neurostimulation, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Fröhlich', 'Affiliation': 'Carolina Center for Neurostimulation, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Department of Neurology, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Department of Biomedical Engineering, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Department of Cell Biology and Physiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Neuroscience Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA. Electronic address: flavio_frohlich@med.unc.edu.'}]",Brain stimulation,['10.1016/j.brs.2021.01.018']
360,33507500,Benefit of Early Add-on of Linagliptin to Insulin in Japanese Patients With Type 2 Diabetes Mellitus: Randomized-Controlled Open-Label Trial (TRUST2).,"INTRODUCTION


This trial was conducted to assess the long-term safety, efficacy, and benefit of early add-on of linagliptin to insulin in patients with type 2 diabetes mellitus (T2DM).
METHODS


This trial enrolled 246 subjects. The subjects were randomized to the linagliptin group or the control group and were observed for 156 weeks. After week 16, subjects in the control group were also allowed to add linagliptin to evaluate the benefit of early add-on of linagliptin to insulin. The primary end point was a change in HbA1c from baseline to week 16. Secondary end points included fasting plasma glucose, daily insulin dose, and frequency of adverse events.
RESULTS


HbA1c and fasting plasma glucose levels significantly decreased from baseline to week 16 in the linagliptin group compared with the control group. The significant improvement in HbA1c continued until week 52. The daily insulin dose significantly decreased in the linagliptin group compared with the control group. The frequency of hypoglycemia and adverse events was comparable in both groups.
CONCLUSIONS


Add-on of linagliptin to insulin was tolerated, improved glycemic control, and reduced the daily insulin dose. This study demonstrates the long-term safety, efficacy and benefit of early add-on of linagliptin to insulin in Japanese T2DM patients.",2021,"RESULTS


HbA1c and fasting plasma glucose levels significantly decreased from baseline to week 16 in the linagliptin group compared with the control group.","['Japanese T2DM patients', '246 subjects', 'patients with type 2 diabetes mellitus (T2DM', 'Japanese Patients With Type 2 Diabetes Mellitus']","['Linagliptin', 'linagliptin', 'linagliptin to insulin']","['change in HbA1c', 'frequency of hypoglycemia and adverse events', 'tolerated, improved glycemic control', 'daily insulin dose', 'HbA1c and fasting plasma glucose levels', 'fasting plasma glucose, daily insulin dose, and frequency of adverse events']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",246.0,0.0422634,"RESULTS


HbA1c and fasting plasma glucose levels significantly decreased from baseline to week 16 in the linagliptin group compared with the control group.","[{'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Katsuno', 'Affiliation': 'Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan. katsunoa@huhs.ac.jp.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Shiraiwa', 'Affiliation': 'Shiraiwa Medical Clinic, Osaka, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Iwasaki', 'Affiliation': 'Iwasaki Internal Medicine Clinic, Osaka, Japan.'}, {'ForeName': 'Hyohun', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Fukuda Clinic, Osaka, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Watanabe', 'Affiliation': 'Watanabe Clinic, Hyogo, Japan.'}, {'ForeName': 'Shizuka', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Takatsuki Red Cross Hospital, Osaka, Japan.'}, {'ForeName': 'Jungo', 'Initials': 'J', 'LastName': 'Terasaki', 'Affiliation': 'Department of Internal Medicine (I), Osaka Medical College, Takatsuki, Osaka, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Hanafusa', 'Affiliation': 'Sakai City Medical Center, Osaka, Japan.'}, {'ForeName': 'Akihisa', 'Initials': 'A', 'LastName': 'Imagawa', 'Affiliation': 'Department of Internal Medicine (I), Osaka Medical College, Takatsuki, Osaka, Japan.'}, {'ForeName': 'Iichiro', 'Initials': 'I', 'LastName': 'Shimomura', 'Affiliation': 'Department of Metabolic Medicine, Graduate School of Medicine, Osaka University, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ikegami', 'Affiliation': 'Department of Endocrinology, Metabolism and Diabetes, Kindai University, Osaka, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Koyama', 'Affiliation': 'Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Namba', 'Affiliation': 'Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Jun-Ichiro', 'Initials': 'JI', 'LastName': 'Miyagawa', 'Affiliation': 'Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-021-01631-y']
361,33507394,Tomographic evaluation of direct pulp capping using a novel injectable treated dentin matrix hydrogel: a 2-year randomized controlled clinical trial.,"OBJECTIVES


To assess clinically and radiographically the success of pulp capping procedure done in traumatically exposed permanent posterior teeth using a novel injectable treated dentin matrix hydrogel (TDMH), Biodentine, and MTA and to evaluate the formed dentin bridge under the capping materials using CBCT imaging.
MATERIALS AND METHODS


45 patients subjected to accidental traumatic pulp exposures by undergraduate dental students are allocated for this study. For each patient, a pulp capping procedure was done. TDMH was formed of TDM powder and sodium alginate to be injected and then hardened in the defect area. Patients were assigned to 3 groups: TDMH, Biodentine, and MTA, respectively, and returned to the clinic after 3, 6, 12, 18, and 24 months for clinical and radiographic examinations. Tomographic data, including thickness and density of formed dentin bridges, were evaluated at the end of the study period compared to the base line. Pulp sensitivity was evaluated throughout the study period using thermal testing and electric pulp tester.
RESULTS


During the follow-up period, all patients were asymptomatic with no clinical signs and symptoms and revealed no radiographic signs of pathosis. However, tomographic evaluation showed the tested materials to have different levels of impact on formed dentin bridges with TDMH group resulted in significantly superior dentin bridges of a higher radiodensity and thickness than Biodentine and MTA.
CONCLUSIONS


TDMH has a greater potential to induce dentin bridge formation than Biodentine and MTA under standardized conditions. Additionally, CBCT imaging was confirmed as a non-invasive and inclusive approach to evaluate the formed dentin bridges after pulp capping procedure.
CLINICAL RELEVANCE


Direct pulp capping can be done successfully with this novel injectable pulp capping material in future clinical applications.
TRIAL REGISTRATION


PACTR201901866476410.",2021,"CLINICAL RELEVANCE


Direct pulp capping can be done successfully with this novel injectable pulp capping material in future clinical applications.
","['45 patients subjected to accidental traumatic pulp exposures by undergraduate dental students', 'traumatically exposed permanent posterior teeth']","['direct pulp capping using a novel injectable treated dentin matrix hydrogel', 'TDMH, Biodentine, and MTA', 'dentin matrix hydrogel (TDMH), Biodentine, and MTA', 'TDMH', 'TDM powder and sodium alginate']","['radiographic signs of pathosis', 'dentin bridge formation', 'Tomographic data, including thickness and density of formed dentin bridges', 'Pulp sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000924', 'cui_str': 'Accident'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0011402', 'cui_str': 'Capping, Dental Pulp'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0142791', 'cui_str': 'Sodium alginate'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C1290645', 'cui_str': 'Dentin bridge'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",45.0,0.0305795,"CLINICAL RELEVANCE


Direct pulp capping can be done successfully with this novel injectable pulp capping material in future clinical applications.
","[{'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Holiel', 'Affiliation': 'Conservative Dentistry Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt. ahmed.holiel@alexu.edu.eg.'}, {'ForeName': 'Elsayed M', 'Initials': 'EM', 'LastName': 'Mahmoud', 'Affiliation': 'Conservative Dentistry Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Wegdan M', 'Initials': 'WM', 'LastName': 'Abdel-Fattah', 'Affiliation': 'Conservative Dentistry Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}]",Clinical oral investigations,['10.1007/s00784-021-03775-1']
362,33509414,A Facebook intervention to address cigarette smoking and heavy episodic drinking: A pilot randomized controlled trial.,"BACKGROUND


Co-occurrence of tobacco use and heavy episodic drinking (HED; 5+ drinks for men and 4+ drinks for women per occasion) is common among young adults; both warrant attention and intervention. In a two-group randomized pilot trial, we investigated whether a Facebook-based smoking cessation intervention addressing both alcohol and tobacco use would increase smoking abstinence and reduce HED compared to a similar intervention addressing only tobacco.
METHODS


Participants were 179 young adults (age 18-25; 49.7% male; 80.4% non-Hispanic white) recruited from Facebook and Instagram who reported smoking 4+ days/week and past-month HED. The Smoking Tobacco and Drinking (STAND) intervention (N = 84) and the Tobacco Status Project (TSP), a tobacco-only intervention (N = 95), both included daily Facebook posts for 90 days and weekly live counseling sessions in private ""secret"" groups. We verified self-reported 7-day smoking abstinence via remote salivary cotinine tests at 3, 6, and 12 months (with retention at 83%, 66%, and 84%, respectively). Participants self-reported alcohol use.
RESULTS


At baseline, the participants averaged 10.4 cigarettes per day (SD = 6.9) and 8.9 HED occasions in the past month (SD = 8.1), with 27.4% in a preparation stage of change for quitting smoking cigarettes. Participants reported significant improvements in cigarette smoking and alcohol use outcomes over time, with no significant differences by condition. At 12 months, intent-to-treat smoking abstinence rates were 3.5% in STAND vs. 0% in TSP (biochemically verified) and 29.4% in STAND vs. 25.5% in TSP (self-reported). Compared to TSP, participants rated the STAND intervention more favorably for supporting health and providing useful information.
CONCLUSIONS


Adding an alcohol treatment component to a tobacco cessation social media intervention was acceptable and engaging but did not result in significant differences by treatment condition in smoking or alcohol use outcomes. Participants in both conditions reported smoking and drinking less over time, suggesting covariation in behavioral changes.",2021,Adding an alcohol treatment component to a tobacco cessation social media intervention was acceptable and engaging but did not result in significant differences by treatment condition in smoking or alcohol use outcomes.,"['Participants were 179 young adults (age 18-25; 49.7% male; 80.4% non-Hispanic white) recruited from Facebook and Instagram who reported smoking 4+ days/week and past-month HED', 'cigarette smoking and heavy episodic drinking']","['Facebook-based smoking cessation intervention addressing both alcohol and tobacco', 'Smoking Tobacco and Drinking (STAND) intervention', 'TSP', 'Facebook intervention', 'Tobacco Status Project (TSP), a tobacco-only intervention (N\xa0=\xa095), both included daily Facebook posts for 90\xa0days and weekly live counseling sessions in private ""secret"" groups']","['smoking abstinence and reduce HED', '7-day smoking abstinence via remote salivary cotinine tests', 'cigarette smoking and alcohol use outcomes', 'intent-to-treat smoking abstinence rates']","[{'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]",179.0,0.0405044,Adding an alcohol treatment component to a tobacco cessation social media intervention was acceptable and engaging but did not result in significant differences by treatment condition in smoking or alcohol use outcomes.,"[{'ForeName': 'Meredith C', 'Initials': 'MC', 'LastName': 'Meacham', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States of America. Electronic address: meredith.meacham@ucsf.edu.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Ramo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States of America; Hopelab, San Francisco, CA, United States of America.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Larissa J', 'Initials': 'LJ', 'LastName': 'Maier', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States of America; Early Postdoc Mobility Grantee, Swiss National Science Foundation, Bern, Switzerland.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States of America; Division of Research, Kaiser Permanente Northern California Region, 2000 Broadway, Oakland, CA, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108211']
363,33514270,Does rTMS Targeting Contralesional S1 Enhance Upper Limb Somatosensory Function in Chronic Stroke? A Proof-of-Principle Study.,"BACKGROUND


Somatosensory deficits are prevalent after stroke, but effective interventions are limited. Brain stimulation of the contralesional primary somatosensory cortex (S1) is a promising adjunct to peripherally administered rehabilitation therapies.
OBJECTIVE


To assess short-term effects of repetitive transcranial magnetic stimulation (rTMS) targeting contralesional (S1) of the upper extremity.
METHODS


Using a single-session randomized crossover design, stroke survivors with upper extremity somatosensory loss participated in 3 rTMS treatments targeting contralesional S1: Sham, 5 Hz, and 1 Hz. rTMS was delivered concurrently with peripheral of sensory electrical stimulation and vibration of the affected hand. Outcomes included 2-point discrimination (2PD), proprioception, vibration perception threshold, monofilament threshold (size), and somatosensory evoked potential (SEP). Measures were collected before, immediately after treatment, and 1 hour after treatment. Mixed models were fit to analyze the effects of the 3 interventions.
RESULTS


Subjects were 59.8 ± 8.1 years old and 45 ± 39 months poststroke. There was improvement in 2PD after 5-Hz rTMS for the stroke-affected ( F (2, 76.163) = 3.5,  P  = .035) and unaffected arm ( F (2, 192.786) = 10.6,  P  < .0001). Peak-to-peak SEP amplitudes were greater after 5-Hz rTMS for N33-P45 ( F (2, 133.027) = 3.518,  P  = .032) and N45-P60 ( F (2, 67.353) = 3.212,  P  = .047). Latencies shortened after 5-Hz rTMS for N20 ( F (2, 69.64) = 3.37,  P  = .04), N60 ( F (2, 47.343) = 4.375,  P  = .018), and P100 ( F (2, 37.608) = 3.537,  P  = .039) peaks. There were no differences between changes immediately after the intervention and an hour later.
CONCLUSIONS


Short-term application of facilitatory high-frequency rTMS (5Hz) to contralesional S1 combined with peripheral somatosensory stimulation may promote somatosensory function. This intervention may serve as a useful adjunct in somatosensory rehabilitation after stroke.",2021,Peak-to-peak SEP amplitudes were greater after 5-Hz rTMS for N33-P45,"['Subjects were 59.8 ± 8.1 years old and 45 ± 39 months poststroke', 'stroke survivors with upper extremity somatosensory loss participated in 3']","['rTMS treatments targeting contralesional S1: Sham, 5 Hz, and 1 Hz', '5-Hz rTMS', 'contralesional primary somatosensory cortex (S1', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS', '5-Hz rTMS for N33-P45']","['Peak-to-peak SEP amplitudes', '2PD', '2-point discrimination (2PD), proprioception, vibration perception threshold, monofilament threshold (size), and somatosensory evoked potential (SEP']","[{'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3496281', 'cui_str': 'Primary Somatic Sensory Area'}, {'cui': 'C1334860', 'cui_str': 'N33 protein, human'}, {'cui': 'C0381943', 'cui_str': 'Skp2 Protein'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}, {'cui': 'C0429277', 'cui_str': 'Two point static discrimination response'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",,0.057305,Peak-to-peak SEP amplitudes were greater after 5-Hz rTMS for N33-P45,"[{'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Pundik', 'Affiliation': 'Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Skelly', 'Affiliation': 'Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McCabe', 'Affiliation': 'Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Akbari', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Tatsuoka', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Ela B', 'Initials': 'EB', 'LastName': 'Plow', 'Affiliation': 'Lerner College of Medicine, Cleveland Clinic, Cleveland, OH, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968321989338']
364,33517233,Acute subjective sensory perceptions predict relative reinforcing effects of smoked nicotine.,"INTRODUCTION


Smoking is believed partially reinforcing via immediate sensory perceptions. Yet, unknown is whether a cigarette's relative reinforcing efficacy can be predicted by these perceptions and whether this relationship may vary due to constituents known to alter those perceptions.
METHODS


Sensory perceptions of acute smoking were examined as predictors of subsequent cigarette choice behavior. Also tested was whether nicotine content or menthol affected this relationship. Adult dependent smokers (N = 37) participated in five sessions comparing cigarettes varying in nicotine contents (NIC; 1.3, 2.3, 5.5, 11.2, and 17.4 mg/g), relative to the very lowest nicotine content, 0.4 mg/g (VLNC). Non-menthol (n = 17) and menthol (n = 20) cigarettes-matched on nicotine-were provided based on participant preference. One NIC was compared versus VLNC per session (single-blinded); NIC content order was randomized across sessions on separate days. Perceptions (e.g., ""liking"", ""satisfying"") were measured immediately after initial sampling of NIC or VLNC, followed by a validated puff-by-puff choice procedure to determine preference for each NIC versus VLNC.
RESULTS


NIC perceptions (difference from VLNC) and puff choices increased with nicotine. Menthol moderated associations between perceptions and nicotine; and between puff choices and nicotine. Perceptions were predictive of puff choice-greater magnitude of difference in perceptions between VLNC and NIC led to more NIC puff choices. When testing perceptions' prediction of puff choices, neither the main effect of menthol or interaction of Perceptions X Nicotine Condition were significant.
CONCLUSIONS


Consistent with assumed-but rarely tested-causes of smoking reinforcement, sensory perceptions from a cigarette predict its relative reinforcing efficacy.",2021,Perceptions were predictive of puff choice-greater magnitude of difference in perceptions between VLNC and NIC led to more NIC puff choices.,"['n\xa0=\xa017) and menthol (n\xa0=\xa020', 'Adult dependent smokers (N\xa0=\xa037']","['menthol', 'nicotine content, 0.4\xa0mg/g (VLNC', 'nicotine', 'smoked nicotine']",[],"[{'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]",[],37.0,0.0296367,Perceptions were predictive of puff choice-greater magnitude of difference in perceptions between VLNC and NIC led to more NIC puff choices.,"[{'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Karelitz', 'Affiliation': 'Division of Cancer Control and Population Sciences, UPMC Hillman Cancer Center, Pittsburgh, PA, USA; Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA; Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: karelitzjl@upmc.edu.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Perkins', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2021.106835']
365,33523279,Robot-assisted vs. laparoscopic repair of complete upside-down stomach hiatal hernia (the RATHER-study): a prospective comparative single center study.,"BACKGROUND


Complete upside-down stomach (cUDS) hernias are a subgroup of large hiatal hernias characterized by high risk of life-threatening complications and technically challenging surgical repair including complex mediastinal dissection. In a prospective, comparative clinical study, we evaluated intra- and postoperative outcomes, quality of life and symptomatic recurrence rates in patients with cUDS undergoing robot-assisted, as compared to standard laparoscopic repair (the RATHER-study).
METHODS


All patients with cUDS herniation requiring elective surgery in our institution between July 2015 and June 2019 were evaluated. Patients undergoing primary open surgery or additional associated procedures were not considered. Primary endpoints were intra- and postoperative complications, 30-day morbidity, and mortality. During the 8-53 months follow-up period, patients were contacted by telephone to assess symptoms associated to recurrence, whereas quality of life was evaluated utilizing the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire.
RESULTS


A total of 55 patients were included. 36 operations were performed with robot-assisted (Rob-G), and 19 with standard laparoscopic (Lap-G) technique. Patients characteristics were similar in both groups. Median operation time was 232 min. (IQR: 145-420) in robot-assisted vs. 163 min. (IQR:112-280) in laparoscopic surgery (p < 0.001). Intraoperative complications occurred in 5/36 (12.5%) cases in the Rob-G group and in 5/19 (26%) cases in the Lap-G group (p = 0.28). No conversion was necessary in either group. Minor postoperative complications occurred in 13/36 (36%) Rob-G patients and 4/19 (21%) Lap-G patients (p = 0.36). Mortality or major complications did not occur in either group. Two asymptomatic recurrences were observed in the Rob-G group only. No patient required revision surgery. Finally, all patients expressed satisfaction for treatment outcome, as indicated by similar GERD-HRQL scores.
CONCLUSION


While robot-assisted surgery provides additional precision, enhanced visualization, and greater feasibility in cUDS hiatal hernia repair, its clinical outcome is at least equal to that obtained by standard laparoscopic surgery.",2022,Minor postoperative complications occurred in 13/36 (36%),"['A total of 55 patients were included', 'patients with cUDS undergoing robot-assisted', 'cUDS hiatal hernia repair', 'Patients undergoing primary open surgery or additional associated procedures', 'All patients with cUDS herniation requiring elective surgery in our institution between July 2015 and June 2019 were evaluated']","['Robot-assisted vs. laparoscopic repair of complete upside-down stomach hiatal hernia', 'standard laparoscopic repair', 'robot-assisted (Rob-G), and 19 with standard laparoscopic (Lap-G) technique']","['revision surgery', 'intra- and postoperative complications, 30-day morbidity, and mortality', 'Intraoperative complications', 'Median operation time', 'Minor postoperative complications', 'quality of life and symptomatic recurrence rates', 'Mortality or major complications', 'GERD-HRQL scores', 'Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire', 'quality of life']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0014857', 'cui_str': 'Repair of paraesophageal diaphragmatic hernia'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C1285504', 'cui_str': 'Associated procedure'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C3489393', 'cui_str': 'Hiatal hernia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",55.0,0.0959557,Minor postoperative complications occurred in 13/36 (36%),"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wilhelm', 'Affiliation': 'Clarunis, Department of Visceral Surgery, University Center for Gastrointestinal and Liver Diseases, St. Clara Hospital and University Hospital Basel, Postfach, 4002, Basel, Switzerland. alexander.wilhelm@clarunis.ch.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Nocera', 'Affiliation': 'Clarunis, Department of Visceral Surgery, University Center for Gastrointestinal and Liver Diseases, St. Clara Hospital and University Hospital Basel, Postfach, 4002, Basel, Switzerland.'}, {'ForeName': 'Romano', 'Initials': 'R', 'LastName': 'Schneider', 'Affiliation': 'Clarunis, Department of Visceral Surgery, University Center for Gastrointestinal and Liver Diseases, St. Clara Hospital and University Hospital Basel, Postfach, 4002, Basel, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Koechlin', 'Affiliation': 'Department of Surgery, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Daume', 'Affiliation': 'Clarunis, Department of Visceral Surgery, University Center for Gastrointestinal and Liver Diseases, St. Clara Hospital and University Hospital Basel, Postfach, 4002, Basel, Switzerland.'}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Fourie', 'Affiliation': 'Clarunis, Department of Visceral Surgery, University Center for Gastrointestinal and Liver Diseases, St. Clara Hospital and University Hospital Basel, Postfach, 4002, Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Steinemann', 'Affiliation': 'Clarunis, Department of Visceral Surgery, University Center for Gastrointestinal and Liver Diseases, St. Clara Hospital and University Hospital Basel, Postfach, 4002, Basel, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'von Flüe', 'Affiliation': 'Clarunis, Department of Visceral Surgery, University Center for Gastrointestinal and Liver Diseases, St. Clara Hospital and University Hospital Basel, Postfach, 4002, Basel, Switzerland.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Peterli', 'Affiliation': 'Clarunis, Department of Visceral Surgery, University Center for Gastrointestinal and Liver Diseases, St. Clara Hospital and University Hospital Basel, Postfach, 4002, Basel, Switzerland.'}, {'ForeName': 'Fiorenzo V', 'Initials': 'FV', 'LastName': 'Angehrn', 'Affiliation': 'Clarunis, Department of Visceral Surgery, University Center for Gastrointestinal and Liver Diseases, St. Clara Hospital and University Hospital Basel, Postfach, 4002, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bolli', 'Affiliation': 'Clarunis, Department of Visceral Surgery, University Center for Gastrointestinal and Liver Diseases, St. Clara Hospital and University Hospital Basel, Postfach, 4002, Basel, Switzerland.'}]",Surgical endoscopy,['10.1007/s00464-021-08307-2']
366,33508690,Within-subject evaluation of interim buprenorphine treatment during waitlist delays.,"BACKGROUND


The effectiveness of opioid agonist treatment for opioid use disorder (OUD) is well established, and delays to treatment are still common, particularly in rural geographic areas. In a randomized 12-week pilot study, we demonstrated initial efficacy of a technology-assisted Interim Buprenorphine Treatment (IBT) vs. continued waitlist control (WLC) for reducing illicit opioid use and other risk behaviors during waitlist delays. Upon completion of that parent trial, WLC participants were given the opportunity to receive 12 weeks of IBT, permitting an additional within-subject examination of IBT effects.
METHODS


Sixteen WLC participants crossed over to receive IBT, involving buprenorphine maintenance with bi-monthly visits, medication administration at home via a computerized device, daily monitoring calls using an Interactive Voice Response (IVR) phone system, and IVR-generated random call-backs. Biochemically-verified illicit opioid abstinence, changes in psychosocial functioning, and HIV + HCV knowledge were examined among participants originally randomized to the WLC phase and who subsequently crossed over to IBT (IBTc).
RESULTS


Participants submitted a higher percentage of illicit opioid negative specimens at Weeks 4, 8, and 12 during IBT (75 %, 63 %, and 50 %) vs. WLC (0%, 0%, and 0%), respectively (p's<.01). Participants also demonstrated improvements in anxiety, depression, and HIV and HCV knowledge (p's<.01). Medication administration, daily IVR call and random call-back adherence and treatment satisfaction were also favorable.
CONCLUSIONS


This within-subject evaluation provides additional support for interim buprenorphine's efficacy in reducing illicit opioid use and improving health outcomes during waitlist delays for more comprehensive treatment.",2021,"RESULTS


Participants submitted a higher percentage of illicit opioid negative specimens at Weeks 4, 8, and 12 during IBT (75 %, 63 %, and 50 %) vs. WLC (0%, 0%, and 0%), respectively (p's<.01).","['Sixteen WLC participants crossed over to receive IBT, involving']","['buprenorphine maintenance with bi-monthly visits, medication administration at home via a computerized device, daily monitoring calls using an Interactive Voice Response (IVR) phone system, and IVR-generated random call-backs', 'buprenorphine', 'technology-assisted Interim Buprenorphine Treatment (IBT) vs. continued waitlist control (WLC']","[""anxiety, depression, and HIV and HCV knowledge (p's<.01"", 'psychosocial functioning, and HIV', 'Medication administration, daily IVR call and random call-back adherence and treatment satisfaction', 'illicit opioid negative specimens']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586143', 'cui_str': 'Monitoring call'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004600', 'cui_str': 'Back'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",16.0,0.0267289,"RESULTS


Participants submitted a higher percentage of illicit opioid negative specimens at Weeks 4, 8, and 12 during IBT (75 %, 63 %, and 50 %) vs. WLC (0%, 0%, and 0%), respectively (p's<.01).","[{'ForeName': 'Tatum N', 'Initials': 'TN', 'LastName': 'Oleskowicz', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, 1 S. Prospect St., Burlington, VT, 05401, USA; Department of Psychological Science, University of Vermont, 2 Colchester Ave., Burlington, VT, 05401, USA.'}, {'ForeName': 'Taylor A', 'Initials': 'TA', 'LastName': 'Ochalek', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, 1 S. Prospect St., Burlington, VT, 05401, USA; Department of Psychological Science, University of Vermont, 2 Colchester Ave., Burlington, VT, 05401, USA.'}, {'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Peck', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, 1 S. Prospect St., Burlington, VT, 05401, USA; Department of Psychological Science, University of Vermont, 2 Colchester Ave., Burlington, VT, 05401, USA; Department of Psychiatry, University of Vermont, 1 S. Prospect St., Burlington, VT, 05401, USA.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Badger', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, 1 S. Prospect St., Burlington, VT, 05401, USA; Department of Medical Biostatistics, University of Vermont, 27 Hills Building, Burlington, VT, 05401, USA.'}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Sigmon', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, 1 S. Prospect St., Burlington, VT, 05401, USA; Department of Psychological Science, University of Vermont, 2 Colchester Ave., Burlington, VT, 05401, USA; Department of Psychiatry, University of Vermont, 1 S. Prospect St., Burlington, VT, 05401, USA. Electronic address: stacey.sigmon@uvm.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108532']
367,33528905,Feasibility of Integration of Yoga in a Behavioral Weight-Loss Intervention: A Randomized Trial.,"OBJECTIVE


This study examined the feasibility and comparison of two styles of yoga within the context of a standard behavioral weight-loss intervention (SBWI).
METHODS


Fifty adults with obesity (BMI: 31.3 ± 3.8 kg/m 2  ) participated in this 6-month study that included a SBWI and a calorie- and fat-reduced diet. Randomization was to restorative Hatha (SBWI+RES) or Vinyasa (SBWI+VIN) yoga. Yoga was prescribed to increase from 20 to 40 to 60 minutes per session across the intervention. Weight was assessed at baseline and 6 months. Perceptions of yoga were assessed at the completion of the intervention.
RESULTS


Adjusted weight loss was -3.4 kg (95% CI: -6.4 to -0.5) in SBWI+RES and -3.8 kg (95% CI: -6.8 to -0.9) in SBWI+VIN (P < 0.001), with no difference between groups. Of all participants, 74.4% reported that they would continue participation in yoga after the SBWI. Session duration was a barrier as yoga increased from 20 to 40 to 60 minutes per day, with 0%, 7.5%, and 48.8% reporting this barrier, respectively.
CONCLUSIONS


Among adults with obesity, yoga participation, within the context of a SBWI, appears to be feasible, with weight loss not differing by style of yoga. Progressing to 60 minutes per session appears to be a barrier to engagement in yoga in this population.",2021,"RESULTS


Adjusted weight loss was -3.4 kg","['adults with obesity, yoga participation', 'Fifty adults with obesity (BMI: 31.3\u2009±\u20093.8 kg/m 2  ) participated in this 6-month study that included a SBWI and a calorie- and fat-reduced diet']","['Behavioral Weight-Loss Intervention', 'restorative Hatha (SBWI+RES) or Vinyasa (SBWI+VIN) yoga', 'standard behavioral weight-loss intervention (SBWI']","['weight loss', 'Weight']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",50.0,0.0682462,"RESULTS


Adjusted weight loss was -3.4 kg","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Healthy Lifestyle Institute, Physical Activity and Weight Management Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Kelliann K', 'Initials': 'KK', 'LastName': 'Davis', 'Affiliation': 'Department of Health and Human Development, University of Pittsburgh, Pittsburgh, Pennsylvania,, USA.'}, {'ForeName': 'Renee J', 'Initials': 'RJ', 'LastName': 'Rogers', 'Affiliation': 'Healthy Lifestyle Institute, Physical Activity and Weight Management Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Sherman', 'Affiliation': 'Department of Health and Human Development, University of Pittsburgh, Pittsburgh, Pennsylvania,, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Barr', 'Affiliation': 'Healthy Lifestyle Institute, Physical Activity and Weight Management Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Marissa L', 'Initials': 'ML', 'LastName': 'Marcin', 'Affiliation': 'Healthy Lifestyle Institute, Physical Activity and Weight Management Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Collins', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University Medical Center, Durham, North Carolina,, USA.'}, {'ForeName': 'Audrey M', 'Initials': 'AM', 'LastName': 'Collins', 'Affiliation': 'Healthy Lifestyle Institute, Physical Activity and Weight Management Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Nalingna', 'Initials': 'N', 'LastName': 'Yuan', 'Affiliation': 'Healthy Lifestyle Institute, Physical Activity and Weight Management Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lang', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.23089']
368,33528318,"Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen in antiretroviral treatment (ART)-naïve and -experienced, virologically-suppressed adults living with HIV-1.","BACKGROUND


Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated in AMBER (treatment-naïve adults; NCT02431247) and EMERALD (treatment-experienced, virologically-suppressed adults; NCT02269917).
OBJECTIVE


To describe a Week 96 pre-planned subgroup analysis of D/C/F/TAF arms by demographic characteristics (age ≤/>50 years, gender, black/non-black race), and baseline clinical characteristics (AMBER: viral load [VL], CD4 +  count, WHO clinical stage, HIV-1 subtype and antiretroviral resistance; EMERALD: prior virologic failure [VF], antiretroviral experience, screening boosted protease inhibitor [PI], and boosting agent).
METHODS


Patients in D/C/F/TAF and control arms could continue on/switch to D/C/F/TAF in a single-arm, open-label extension phase after Week 48 until Week 96. Efficacy endpoints were percentage cumulative confirmed VL ≥50 copies/mL (virologic rebound; EMERALD), and VL <50 (virologic response), or ≥50 copies/mL (VF) (FDA snapshot; both trials).
RESULTS


D/C/F/TAF demonstrated high Week 96 virologic responses (AMBER: 85% [308/362]; EMERALD: 91% [692/763]) and low VF rates (AMBER: 6% [20/362]; EMERALD: 1% [9/763]). In EMERALD, D/C/F/TAF showed low virologic rebound cumulative through Week 96 (3% [24/763]). Results were consistent across subgroups, including prior antiretroviral experience in EMERALD. No darunavir, primary PI, or tenofovir resistance-associated mutations were observed post-baseline. Study-drug-related serious adverse events (AEs) and AE-related discontinuations were <1% and 2%, respectively (both D/C/F/TAF arms), and similar across subgroups. eGFR cyst  and bone mineral density improved or were stable and lipids increased through Week 96 across demographic subgroups, with small changes in total-cholesterol/HDL-cholesterol ratio.
CONCLUSIONS


D/C/F/TAF was effective with a high barrier to resistance and bone/renal safety benefits, regardless of demographic or clinical characteristics for treatment-naïve and treatment-experienced, virologically-suppressed adults.",2020,"eGFR cyst  and bone mineral density improved or were stable and lipids increased through Week 96 across demographic subgroups, with small changes in total-cholesterol/HDL-cholesterol ratio.
","['antiretroviral treatment (ART)-naïve and -experienced, virologically-suppressed adults living with HIV-1', 'Patients in D/C/F/TAF and control arms could continue on/switch to D/C/F/TAF in a single-arm, open-label extension phase after Week 48 until Week 96']","['daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF', 'Darunavir/cobicistat/emtricitabine/tenofovir alafenamide', 'antiretroviral experience, screening boosted protease inhibitor [PI], and boosting agent']","['low virologic rebound cumulative', 'total-cholesterol/HDL-cholesterol ratio', 'efficacy and safety', 'No darunavir, primary PI, or tenofovir resistance-associated mutations', 'percentage cumulative confirmed VL ≥50 copies/mL (virologic rebound; EMERALD), and VL <50 (virologic response), or ≥50 copies/mL (VF) (FDA snapshot; both trials', 'eGFR cyst  and bone mineral density']","[{'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3871454', 'cui_str': 'darunavir and cobicistat'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine and tenofovir alafenamide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3871454', 'cui_str': 'darunavir and cobicistat'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine and tenofovir alafenamide'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",,0.0699848,"eGFR cyst  and bone mineral density improved or were stable and lipids increased through Week 96 across demographic subgroups, with small changes in total-cholesterol/HDL-cholesterol ratio.
","[{'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Huhn', 'Affiliation': 'Ruth M. Rothstein CORE Center, Chicago, IL, USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Wilkin', 'Affiliation': 'Section on Infectious Diseases, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Mussini', 'Affiliation': 'Department of Infectious Diseases, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Christoph D', 'Initials': 'CD', 'LastName': 'Spinner', 'Affiliation': 'School of Medicine, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jezorwski', 'Affiliation': 'Janssen Research and Development LLC, Pennington, NJ, USA.'}, {'ForeName': 'Mohsine', 'Initials': 'M', 'LastName': 'El Ghazi', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Van Landuyt', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Erkki', 'Initials': 'E', 'LastName': 'Lathouwers', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Baugh', 'Affiliation': 'Janssen Research and Development LLC, Raritan, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",HIV research & clinical practice,['10.1080/25787489.2020.1844520']
369,33527249,Patient and provider satisfaction with saline ultrasound versus office hysteroscopy for uterine cavity evaluation prior to in vitro fertilization: a randomized controlled trial.,"PURPOSE


To compare patient and provider satisfaction with saline ultrasound (SIS) versus office hysteroscopy for cavity evaluation prior to in vitro fertilization (IVF) and to assess the capability of hysteroscopy to manage pathology at time of diagnosis to reduce delays and supernumerary procedures.
METHODS


This was a randomized, controlled trial in a university fertility clinic. One hundred enrolled subjects undergoing routine uterine cavity evaluation prior to planned embryo transfer were randomized to SIS or office hysteroscopy without anesthesia. Subjects and providers completed surveys about their experience. Subjects with findings on SIS had a hysteroscopy performed or scheduled for further evaluation. Those with hysteroscopy findings had management attempted within the same procedure.
RESULTS


Overall patient satisfaction was high and did not differ between groups, while providers indicated that hysteroscopy provided a better cavity evaluation. There was no difference in time to complete procedures between groups. Pain score on a ten-scale was slightly higher in the hysteroscopy group compared to the SIS group (3.38 ± 1.85 vs. 2.44 ± 1.64, p < 0.01), but this did not impact satisfaction scores. Although pathology was found in a similar rate (22% vs. 36% for SIS and HSC groups, respectively), those in the SIS group all required secondary procedures, while only 1/17 did in the HSC group (p < 0.01).
CONCLUSION


Although the hysteroscopy group exhibited slightly higher pain scores, overall patient and provider satisfaction was high and similar between groups. There were significantly fewer secondary procedures and delays in the hysteroscopy group. Hysteroscopy is a reasonable first line screening tool for patients requiring cavity evaluation.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT04415489.",2021,"Pain score on a ten-scale was slightly higher in the hysteroscopy group compared to the SIS group (3.38 ± 1.85 vs. 2.44 ± 1.64, p < 0.01), but this did not impact satisfaction scores.","['Subjects with findings on SIS had a hysteroscopy performed or scheduled for further evaluation', 'One hundred enrolled subjects undergoing routine uterine cavity evaluation prior to planned embryo transfer', 'patients requiring cavity evaluation', 'university fertility clinic', 'uterine cavity evaluation prior to in vitro fertilization']","['saline ultrasound (SIS) versus office hysteroscopy', 'SIS or office hysteroscopy without anesthesia', 'Hysteroscopy', 'saline ultrasound versus office hysteroscopy']","['Pain score', 'pain scores, overall patient and provider satisfaction']","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0227844', 'cui_str': 'Endometrial cavity structure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4760630', 'cui_str': 'Infertility Clinics'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",100.0,0.143308,"Pain score on a ten-scale was slightly higher in the hysteroscopy group compared to the SIS group (3.38 ± 1.85 vs. 2.44 ± 1.64, p < 0.01), but this did not impact satisfaction scores.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Moustafa', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA. sarah_moustafa@med.unc.edu.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Rosen', 'Affiliation': 'Gillings School of Public Health, University of North Carolina School, Chapel Hill, NC, USA.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Goodman', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-021-02065-9']
370,33534750,Therapeutic Response to Thermotherapy in Cutaneous Leishmaniasis Treatment Failures for Sodium Stibogluconate: A Randomized Controlled Proof of Principle Clinical Trial.,"Treatment failure to intralesional sodium stibogluconate (IL-SSG) is a health challenge for cutaneous leishmaniasis (CL) in Sri Lanka. A randomized controlled proof of principle clinical trial, with two arms (viz., radio frequency-induced heat therapy [RFHT] by a ThermoMed™ device (Model 1.8, Thermosurgery Technologies, Inc., Phoenix, AZ) and thermotherapy by a handheld exothermic crystallization thermotherapy for CL [HECT-CL] device) was conducted on 40 CL treatment failures to IL-SSG, from three hospitals in Tangalle, Hambantota, and Anuradhapura, from January 2017 to January 2018, followed up for 180 days post-thermotherapy with a final follow-up in February 2020. Intention-to-treat cure rates were calculated at day 90 (initial cure rate) and at day 180 (final cure rate) posttreatment. Radio frequency-induced heat therapy group: the initial cure rate was 100% (20/20) and the final cure rate was 95% (19/20), with one patient relapsing. The HECT-CL group: both the initial and final cure rates were 80% (16/20), with no relapses and one excluded from the trial. In February 2020 (1.6-3 years posttreatment), 27 traceable patients (RFHT = 16, HECT-CL = 11) remained healed. Second-degree burns were observed with RFHT in 65% (13/20), with HECT-CL in 15% (3/20), which completely resolved subsequently. The cure rates between the two treatment groups were comparable (P = 0.15). Radio frequency-induced heat therapy consumed less time and required only a single hospital visit. Handheld exothermic crystallization thermotherapy for CL is potentially usable at community settings with both being less costly than IL-SSG. This study is the first proof that thermotherapy is an efficacious and safe treatment for CL patients in Sri Lanka, complicated by treatment failure to IL-SSG.",2021,Handheld exothermic crystallization thermotherapy for CL is potentially usable at community settings with both being less costly than IL-SSG.,"['40 CL treatment failures to IL-SSG, from three hospitals in Tangalle, Hambantota, and Anuradhapura, from January 2017 to January 2018, followed up for 180 days post-thermotherapy with a final follow-up in February 2020', 'cutaneous leishmaniasis (CL) in Sri Lanka', 'Cutaneous Leishmaniasis Treatment Failures for Sodium Stibogluconate']","['Radio frequency-induced heat therapy group', 'RFHT', 'Thermotherapy', 'radio frequency-induced heat therapy [RFHT', 'intralesional sodium stibogluconate (IL-SSG', 'HECT-CL', 'Radio frequency-induced heat therapy']","['final cure rates', 'final cure rate', 'Intention-to-treat cure rates', 'cure rates', 'initial cure rate']","[{'cui': 'C0023283', 'cui_str': 'Cutaneous leishmaniasis'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0030895', 'cui_str': 'Sodium Stibogluconate'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0020548', 'cui_str': 'Thermotherapy'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}]","[{'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020548', 'cui_str': 'Thermotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0030895', 'cui_str': 'Sodium Stibogluconate'}, {'cui': 'C0023283', 'cui_str': 'Cutaneous leishmaniasis'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",,0.043705,Handheld exothermic crystallization thermotherapy for CL is potentially usable at community settings with both being less costly than IL-SSG.,"[{'ForeName': 'Hermali', 'Initials': 'H', 'LastName': 'Silva', 'Affiliation': '1Department of Parasitology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Achala', 'Initials': 'A', 'LastName': 'Liyanage', 'Affiliation': '2Base Hospital, Tangalle, Sri Lanka.'}, {'ForeName': 'Theja', 'Initials': 'T', 'LastName': 'Deerasinghe', 'Affiliation': '3District General Hospital Hambantota, Hambantota, Sri Lanka.'}, {'ForeName': 'Buthsiri', 'Initials': 'B', 'LastName': 'Sumanasena', 'Affiliation': '4Teaching Hospital Anuradhapura, Anuradhapura, Sri Lanka.'}, {'ForeName': 'Deepani', 'Initials': 'D', 'LastName': 'Munidasa', 'Affiliation': '4Teaching Hospital Anuradhapura, Anuradhapura, Sri Lanka.'}, {'ForeName': 'Hiromel', 'Initials': 'H', 'LastName': 'de Silva', 'Affiliation': '2Base Hospital, Tangalle, Sri Lanka.'}, {'ForeName': 'Sudath', 'Initials': 'S', 'LastName': 'Weerasingha', 'Affiliation': '1Department of Parasitology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Rohini', 'Initials': 'R', 'LastName': 'Fernandopulle', 'Affiliation': '5General Sir John Kotelawala Defence University, Dehiwala-Mount Lavinia, Sri Lanka.'}, {'ForeName': 'Nadira', 'Initials': 'N', 'LastName': 'Karunaweera', 'Affiliation': '1Department of Parasitology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0855']
371,33534613,Bridge-Enhanced Anterior Cruciate Ligament Repair Leads to Greater Limb Asymmetry and Less Cartilage Damage Than Untreated ACL Transection or ACL Reconstruction in the Porcine Model.,"BACKGROUND


The extent of posttraumatic osteoarthritis (PTOA) in the porcine anterior cruciate ligament (ACL) transection model is dependent on the surgical treatment selected. In a previous study, animals treated with bridge-enhanced ACL repair using a tissue-engineered implant developed less PTOA than those treated with ACL reconstruction (ACLR). Alterations in gait, including asymmetric weightbearing and shorter stance times, have been noted in clinical studies of subjects with osteoarthritis.
HYPOTHESIS


Animals receiving a surgical treatment that results in less PTOA (ie, bridge-enhanced ACL repair) would exhibit fewer longitudinal postoperative gait asymmetries over a 1-year period when compared with treatments that result in greater PTOA (ie, ACLR and ACL transection).
STUDY DESIGN


Controlled laboratory study.
METHODS


Thirty-six Yucatan minipigs underwent ACL transection and were randomized to receive (1) no further treatment, (2) ACLR, or (3) bridge-enhanced ACL repair. Gait analyses were performed preoperatively, and at 4, 12, 26, and 52 weeks postoperatively. Macroscopic cartilage assessments were performed at 52 weeks.
RESULTS


Knees treated with bridge-enhanced ACL repair had less macroscopic damage in the medial tibial plateau than those treated with ACLR or ACL transection (adjusted  P  = .03 for both comparisons). The knees treated with bridge-enhanced ACL repair had greater asymmetry in hindlimb maximum force and impulse loading at 52 weeks than the knees treated with ACL transection (adjusted  P  < .05 for both comparisons). Although not significant, there was a trend that knees treated with bridge-enhanced ACL repair had greater asymmetry in hindlimb maximum force and impulse loading (adjusted  P  < .10 for both comparisons) compared with ACLR.
CONCLUSION


Contrary to our hypothesis, the surgical treatment resulting in less macroscopic cartilage damage (ie, bridge-enhanced ACL repair) exhibited greater asymmetry in load-related gait parameters than the other surgical groups. This finding suggests that increased offloading of the surgical knee may be associated with a slower rate of PTOA development.
CLINICAL RELEVANCE


Less cartilage damage at 52 weeks was found in the surgical group that continued to protect the limb from full body weight during gait. This finding suggests that protection of the knee from maximum stresses may be important in minimizing the development of PTOA in the ACL-injured knee within 1 year.",2021,"CLINICAL RELEVANCE


Less cartilage damage at 52 weeks was found in the surgical group that continued to protect the limb from full body weight during gait.","['Thirty-six Yucatan minipigs', 'porcine anterior cruciate ligament (ACL) transection model', 'subjects with osteoarthritis']","['bridge-enhanced ACL repair', 'ACL reconstruction (ACLR', 'Untreated ACL Transection or ACL Reconstruction', 'ACL transection', 'receive (1) no further treatment, (2) ACLR, or (3) bridge-enhanced ACL repair', 'Bridge-Enhanced Anterior Cruciate Ligament Repair']","['medial tibial plateau', 'macroscopic damage', 'Macroscopic cartilage assessments', 'hindlimb maximum force and impulse loading', 'longitudinal postoperative gait asymmetries', 'macroscopic cartilage damage']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C1269265', 'cui_str': 'Yucatan Miniature pig'}, {'cui': 'C0039011', 'cui_str': 'Miniature Swine'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0152060', 'cui_str': 'Transection'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0152060', 'cui_str': 'Transection'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0584640', 'cui_str': 'Tibial plateau structure'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0549421', 'cui_str': 'Cartilage damage'}]",,0.0238024,"CLINICAL RELEVANCE


Less cartilage damage at 52 weeks was found in the surgical group that continued to protect the limb from full body weight during gait.","[{'ForeName': 'Naga Padmini', 'Initials': 'NP', 'LastName': 'Karamchedu', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University/Rhode Island Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Martha M', 'Initials': 'MM', 'LastName': 'Murray', 'Affiliation': ""Division of Sports Medicine, Department of Orthopedic Surgery, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Jakob T', 'Initials': 'JT', 'LastName': 'Sieker', 'Affiliation': ""Division of Sports Medicine, Department of Orthopedic Surgery, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Benedikt L', 'Initials': 'BL', 'LastName': 'Proffen', 'Affiliation': ""Division of Sports Medicine, Department of Orthopedic Surgery, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Portilla', 'Affiliation': ""Division of Sports Medicine, Department of Orthopedic Surgery, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Meggin Q', 'Initials': 'MQ', 'LastName': 'Costa', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University/Rhode Island Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Molino', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University/Rhode Island Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Braden C', 'Initials': 'BC', 'LastName': 'Fleming', 'Affiliation': 'Department of Orthopaedics, Warren Alpert Medical School of Brown University/Rhode Island Hospital, Providence, Rhode Island, USA.'}]",The American journal of sports medicine,['10.1177/0363546521989265']
372,33537871,Efficacy of Agomelatine 25-50 mg for the Treatment of Anxious Symptoms and Functional Impairment in Generalized Anxiety Disorder: A Meta-Analysis of Three Placebo-Controlled Studies.,"INTRODUCTION


The purpose of this study is to investigate the effects of agomelatine on anxious symptoms and functional impairment in a pooled dataset from randomized placebo-controlled trials for generalized anxiety disorder (GAD).
METHODS


Data from three randomized, placebo-controlled trials that evaluated the efficacy of agomelatine 25-50 mg were pooled. The short-term (12 weeks) efficacy of agomelatine was assessed in regards to (1) anxious symptoms using the Hamilton Anxiety Scale (HAM-A), and (2) functional impairment using the Sheehan Disability Scale (SDS). Meta-analysis using a random effect model was used to assess differences between groups. Remission and response rates for the HAM-A and SDS were calculated, and analyses were repeated in participants with more severe anxiety symptoms.
RESULTS


In total, 669 patients (340 on agomelatine; 329 on placebo) were included in the analyses. Compared to placebo, the agomelatine group had a significant reduction in HAM-A total score at week 12 (between group difference: 6.30 ± 2.51, p = 0.012). Significant effects were also found for symptom response on the HAM-A (67.1% of patients on agomelatine vs. 32.5% on placebo) and symptom remission (38.8% of patients on agomelatine vs. 17.3% on placebo). Compared to placebo, there was a significant difference in favour of the agomelatine group at week 12 on the SDS total score (5.11 ± 1.81, p = 0.005). Significant effects were also found for functional response on the SDS (79.1% of patients on agomelatine vs. 43.2% of placebo) and functional remission (55.2% of patients on agomelatine vs. 25.4% on placebo). All findings for anxious symptoms and functional impairment were confirmed in the subset of more severely anxious patients. Agomelatine was well tolerated by patients.
CONCLUSION


This meta-analysis confirms that agomelatine reduces anxiety symptoms and improves the global functioning of GAD patients.",2021,"Compared to placebo, there was a significant difference in favour of the agomelatine group at week 12 on the SDS total score (5.11 ± 1.81, p = 0.005).","['generalized anxiety disorder (GAD', '669 patients (340 on agomelatine; 329 on', 'Anxious Symptoms and Functional Impairment in Generalized Anxiety Disorder']","['agomelatine', 'Agomelatine', 'placebo']","['regards to (1) anxious symptoms using the Hamilton Anxiety Scale (HAM-A), and (2) functional impairment using the Sheehan Disability Scale (SDS', 'anxiety symptoms', 'severe anxiety symptoms', 'SDS total score', 'HAM-A total score', 'functional response on the SDS', 'Remission and response rates', 'symptom remission', 'symptom response on the HAM-A', 'functional remission', 'anxious symptoms and functional impairment']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0971637', 'cui_str': 'agomelatine'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C0971637', 'cui_str': 'agomelatine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",669.0,0.200147,"Compared to placebo, there was a significant difference in favour of the agomelatine group at week 12 on the SDS total score (5.11 ± 1.81, p = 0.005).","[{'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'SAMRC Unit on Risk and Resilience in Mental Disorders, Department of Psychiatry and Neuroscience Institute, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa. dan.stein@uct.ac.za.'}, {'ForeName': 'Jon-Paul', 'Initials': 'JP', 'LastName': 'Khoo', 'Affiliation': 'Toowong Specialist Clinic, Toowong, Brisbane, Australia.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Picarel-Blanchot', 'Affiliation': 'Servier Affaires Médicales, Suresnes Cedex, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Olivier', 'Affiliation': 'Institut de Recherches Internationales Servier (IRIS), Suresnes Cedex, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Van Ameringen', 'Affiliation': 'Department of Psychiatry and Behavioural Neuroscience, McMaster University-MacAnxiety Research Centre, Hamilton, ON, Canada.'}]",Advances in therapy,['10.1007/s12325-020-01583-9']
373,33547218,Optimal Phosphate Control Related to Coronary Artery Calcification in Dialysis Patients.,"BACKGROUND


In patients on maintenance dialysis, cardiovascular mortality risk is remarkably high, which can be partly explained by severe coronary artery calcification (CAC). Hyperphosphatemia has been reported to be associated with the severity of CAC. However, the optimal phosphate range in patients on dialysis remains unknown. This study was planned to compare the effects on CAC progression of two types of noncalcium-based phosphate binders and of two different phosphate target ranges.
METHODS


We conducted a randomized, open-label, multicenter, interventional trial with a two by two factorial design. A total of 160 adults on dialysis were enrolled and randomized to the sucroferric oxyhydroxide or lanthanum carbonate group, with the aim of reducing serum phosphate to two target levels (3.5-4.5 mg/dl in the strict group and 5.0-6.0 mg/dl in the standard group). The primary end point was percentage change in CAC scores during the 12-month treatment.
RESULTS


The full analysis set included 115 patients. We observed no significant difference in percentage change in CAC scores between the lanthanum carbonate group and the sucroferric oxyhydroxide group. On the other hand, percentage change in CAC scores in the strict group (median of 8.52; interquartile range, -1.0-23.9) was significantly lower than that in the standard group (median of 21.8; interquartile range, 10.0-36.1;  P =0.006). This effect was pronounced in older (aged 65-74 years) versus younger (aged 20-64 years) participants ( P  value for interaction =0.003). We observed a similar finding for the absolute change in CAC scores.
CONCLUSIONS


Further study with a larger sample size is needed, but strict phosphate control shows promise for delaying progression of CAC in patients undergoing maintenance hemodialysis.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Evaluate the New Phosphate Iron-Based Binder Sucroferric Oxyhydroxide in Dialysis Patients with the Goal of Advancing the Practice of EBM (EPISODE), jRCTs051180048.",2021,This effect was pronounced in older (aged 65-74 years) versus younger (aged 20-64 years) participants ( P  value for interaction =0.003).,"['160 adults on dialysis', 'Dialysis Patients with the Goal of Advancing the Practice of EBM', '115 patients', 'patients undergoing maintenance hemodialysis', 'Dialysis Patients', 'older (aged 65-74 years) versus younger (aged 20-64 years) participants ( P  value for interaction =0.003']","['sucroferric oxyhydroxide or lanthanum carbonate', 'lanthanum carbonate', 'New Phosphate Iron-Based Binder Sucroferric Oxyhydroxide']","['Coronary Artery Calcification', 'CAC scores', 'percentage change in CAC scores']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0795974', 'cui_str': 'Epidermolysis Bullosa, Macular Type'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C4517388', 'cui_str': '0.003'}]","[{'cui': 'C3696416', 'cui_str': 'sucroferric oxyhydroxide'}, {'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0179302', 'cui_str': 'Binder'}]","[{'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",160.0,0.0552949,This effect was pronounced in older (aged 65-74 years) versus younger (aged 20-64 years) participants ( P  value for interaction =0.003).,"[{'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Isaka', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Japan isaka@kid.med.osaka-u.ac.jp.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Hamano', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Division of Nephrology and Kidney Center, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Tsujimoto', 'Affiliation': 'Division of Internal Medicine, Medical Corporation Aijinkai Inoue Hospital, Suita, Japan.'}, {'ForeName': 'Fumihiko', 'Initials': 'F', 'LastName': 'Koiwa', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Sakaguchi', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': 'Department of Radiology, Iwate Medical University School of Medicine, Shiwa, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Radiology, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Fuminari', 'Initials': 'F', 'LastName': 'Tatsugami', 'Affiliation': 'Department of Diagnostic Radiology, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Teramukai', 'Affiliation': 'Department of Biostatistics, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020050598']
374,33540223,The role of social isolation in physical and emotional outcomes among patients with chronic pain.,"OBJECTIVE


Social isolation negatively impacts early-disease processes and long-term health. Individuals with chronic pain are more vulnerable to social isolation, which exacerbates symptoms. It is currently unclear whether: 1. group-based programs for chronic pain improve social isolation, 2. improvements in social isolation account for improvements in outcomes. This study involved secondary data analysis of participants in a 10-week mind-body physical activity program. We examined whether social isolation improved during treatment, and whether such improvements accounted for improvements in emotional and physical functioning.
METHODS


Participants (N = 82) with chronic pain were randomized to a group-based mind-body physical activity intervention with (GetActive-Fitbit; n = 41) or without a Fitbit device (GetActive; n = 41). Participants completed self-reported measures of social isolation, emotional functioning (depression and anxiety symptoms), and multimodal physical functioning (self-report, performance-based, and objective). We used linear mixed effects modeling to examine pre-post treatment changes in social isolation and whether these changes accounted for improvements in emotional and physical functioning.
RESULTS


Both interventions were associated with significant and comparable improvements in social isolation from baseline to end of treatment, and improvements in social isolation accounted for significant improvements in self-reported emotional and physical functioning.
CONCLUSION


Interventions may target social isolation in chronic pain to optimize treatment outcomes.",2021,"Both interventions were associated with significant and comparable improvements in social isolation from baseline to end of treatment, and improvements in accounted for significant improvements in self-reported emotional and physical functioning.
","['Participants (N\xa0=\xa082) with chronic pain', 'participants in a 10-week mind-body physical activity program', 'Individuals with chronic pain', 'patients with chronic pain']",['group-based mind-body physical activity intervention with (GetActive-Fitbit; n\xa0=\xa041) or without a Fitbit device (GetActive; n\xa0=\xa041'],"['self-reported emotional and physical functioning', 'social isolation, emotional functioning (depression and anxiety symptoms), and multimodal physical functioning (self-report, performance-based, and objective', 'social isolation', 'emotional and physical functioning']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",82.0,0.0385238,"Both interventions were associated with significant and comparable improvements in social isolation from baseline to end of treatment, and improvements in accounted for significant improvements in self-reported emotional and physical functioning.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bannon', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Greenberg', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Mace', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Locascio', 'Affiliation': 'Harvard Medical School, Boston, MA, USA; Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA; Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: avranceanu@mgh.harvard.edu.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2021.01.009']
375,33539149,Effects of acute stress on cognition in older versus younger adults.,"Does acute stress differentially alter cognitive functioning in older versus younger adults? While older adults may be better at handling stress psychologically, their physiological systems are less elastic, potentially impairing the cognitive functioning of older adults after a stressor. We examined cognition following an acute stressor among older ( n  = 65; ages 60-79) and younger ( n  = 61; ages 25-40) adults. Participants were randomized to complete the Trier Social Stress Test (TSST) in one of three conditions: (a) negative feedback, (b) positive feedback, or (c) no feedback. Participants reported mood states and appraisals of the speech task and we measured cortisol via saliva throughout the study. After the TSST, participants completed standard cognitive tasks to evaluate cognitive flexibility, problem solving, and short-term memory. Results showed that after the TSST, older adults took longer to solve problems compared with younger adults, though they were able to solve the same number of problems. Older adults showed less cognitive flexibility compared with younger adults in all conditions, a finding that was partially exaggerated in the positive feedback condition. There were no age-group differences in short-term memory; however, for older adults greater perceived resources and positive affect were associated with better memory performance. In sum, older and younger adults were both affected by acute stress, and older adults were not more (or less) vulnerable to the effects of stress on cognition, though they did show stronger associations between self-reported affective states and memory performance. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Results showed that after the TSST, older adults took longer to solve problems compared with younger adults, though they were able to solve the same number of problems.","['older versus younger adults', 'acute stressor among older ( n  = 65; ages 60-79) and younger ( n  = 61; ages 25-40) adults', 'Older adults']","['Trier Social Stress Test (TSST) in one of three conditions: (a) negative feedback, (b) positive feedback, or (c) no feedback', 'TSST']","['cognitive flexibility', 'cognitive functioning', 'standard cognitive tasks to evaluate cognitive flexibility, problem solving, and short-term memory', 'mood states and appraisals of the speech task and we measured cortisol via saliva', 'memory performance']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}]",,0.0764512,"Results showed that after the TSST, older adults took longer to solve problems compared with younger adults, though they were able to solve the same number of problems.","[{'ForeName': 'Alexandra D', 'Initials': 'AD', 'LastName': 'Crosswell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Whitehurst', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Wendy Berry', 'Initials': 'WB', 'LastName': 'Mendes', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}]",Psychology and aging,['10.1037/pag0000589']
376,33544305,"Onset, Maintenance, and Cessation of Effect of Galcanezumab for Prevention of Migraine: A Narrative Review of Three Randomized Placebo-Controlled Trials.","INTRODUCTION


Galcanezumab, a humanized monoclonal antibody that binds to calcitonin gene-related peptide, is approved for the preventive treatment of migraine in adults. It is self-administered once monthly as a subcutaneous injection. This paper describes the time course of effect of galcanezumab in patients with episodic and chronic migraine.
METHODS


Data were based on three double-blind, placebo-controlled, phase 3 studies. Patients (1773 episodic and 1113 chronic) were randomized (2:1:1) to monthly doses of placebo, galcanezumab 120 mg with a 240 mg loading dose, or galcanezumab 240 mg (January 2016-March 2017). Onset of effect was determined using a sequential analysis approach based on earliest time point at which galcanezumab achieved and subsequently maintained statistical superiority to placebo. Maintenance of effect was a comparison of the percentages of galcanezumab- and placebo-treated patients with maintenance of at least 50% response at the individual patient level. Cessation of effect was determined during a 4-month post-treatment period on the basis of change from baseline in monthly migraine headache days.
RESULTS


Galcanezumab led to a lower percentage of patients who had a migraine headache on the first day after injection, provided maintenance of effect throughout the duration of the double-blind treatment period, and gradually lost effect without signs of rebound headache throughout the post-treatment period in most patients with episodic and chronic migraine.
CONCLUSION


Galcanezumab is a novel preventive therapeutic option for adult patients with migraine that has early onset of action, maintenance of effect, and gradual reduction of effect upon treatment cessation.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02614183 (EVOLVE-1); NCT02614196 (EVOLVE-2); NCT02614261 (REGAIN).",2021,"RESULTS


Galcanezumab led to a lower percentage of patients who had a migraine headache on the first day after injection, provided maintenance of effect throughout the duration of the double-blind treatment period, and gradually lost effect without signs of rebound headache throughout the post-treatment period in most patients with episodic and chronic migraine.
","['treated patients with maintenance of at least 50% response at the individual patient level', 'patients with episodic and chronic migraine', 'Patients (1773 episodic and 1113 chronic', 'adult patients with migraine', 'Migraine']","['galcanezumab- and placebo', 'galcanezumab', 'placebo', 'Galcanezumab', 'placebo, galcanezumab 120\xa0mg with a 240\xa0mg loading dose, or galcanezumab', 'Placebo']","['rebound headache', 'migraine headache']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0520961', 'cui_str': 'Drug withdrawal headache'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]",,0.233367,"RESULTS


Galcanezumab led to a lower percentage of patients who had a migraine headache on the first day after injection, provided maintenance of effect throughout the duration of the double-blind treatment period, and gradually lost effect without signs of rebound headache throughout the post-treatment period in most patients with episodic and chronic migraine.
","[{'ForeName': 'Dulanji K', 'Initials': 'DK', 'LastName': 'Kuruppu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA. kuruppu_dulanji@lilly.com.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'North', 'Affiliation': 'Health Center on Broad Street, Glens Falls, NY, USA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Kovacik', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Hutchinson', 'Affiliation': 'Orange County Migraine and Headache Center, Irvine, CA, USA.'}]",Advances in therapy,['10.1007/s12325-021-01632-x']
377,33548303,"Topical timolol 0.5% gel-forming solution for erythema in rosacea: A quantitative, split-face, randomized, and rater-masked pilot clinical trial.",,2021,,['for Erythema in Rosacea'],['Topical Timolol 0.5% Gel-Forming Solution'],[],"[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]",[],,0.365336,,"[{'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Tsai', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Chien', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Noori', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Rachidi', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Connolly', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Hester', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Sabrina Sisto', 'Initials': 'SS', 'LastName': 'Alessi César', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Sewon', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Garza', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: LAG@jhmi.edu.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2021.01.098']
378,33559245,Efficacy of transforaminal epidural magnesium administration when combined with a local anaesthetic and steroid in the management of lower limb radicular pain.,"BACKGROUND


Lower limb radicular pain resulting from a herniated intervertebral disc is a cause of functional disability and could lead to increased consumption of opioids. We evaluated the efficacy of epidural magnesium combined with a local anaesthetic and steroid in the management of this pain.
METHODS


This was a prospective, case-control, randomized, double-blind study. Fifty patients each received 2 ml bupivacaine, 1 ml (40 mg) methylprednisolone and 1 ml saline (0.9%) (group C) or magnesium (200 mg) instead of saline (group M). The primary outcome measure was the improvement in the pain score (assessed using a visual analogue scale (VAS)), and the secondary outcome was the improvement in the functional ability (assessed using the Modified Oswestry Disability Questionnaire (MODQ)). The VAS and MODQ scores were assessed before and at 1 day, 1 week, 1 month and 3 months post-intervention.
RESULTS


The VAS and MODQ scores were significantly better in group M compared to those in group C at all times post-injection (p-value < 0.001). Comparisons within the same group showed that the VAS and MODQ scores were significantly better at all post-injection time points compared to the pre-injection scores in both group C and group M (p-values < 0.0001).
CONCLUSIONS


Adding magnesium to a local anaesthetic and steroid to be injected in the transforaminal epidural space could improve the pain and the quality of life in patients suffering from lower limb radicular pain due to lumbo-sacral disc herniation, and this improvement could last for up to 3 months.
SIGNIFICANCE


Magnesium is efficient when added to local anaesthetics and steroids for management of lower limb radicular pain.",2021,The VAS and MODQ scores were significantly better in group M compared to those in group C at all times post-injection (P-value < 0.001).,"['lower limb radicular pain', 'Fifty patients each received']","['magnesium (200 mg) instead of saline', 'magnesium', 'epidural magnesium combined with a local anesthetic and steroid', '2 mL bupivacaine, 1 mL (40 mg) methylprednisolone, and 1 mL saline', 'transforaminal epidural magnesium']","['pain score (assessed using a visual analog scale (VAS', 'pain and the quality of life', 'functional ability (assessed using the Modified Oswestry Disability Questionnaire (MODQ', 'VAS and MODQ scores']","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.114325,The VAS and MODQ scores were significantly better in group M compared to those in group C at all times post-injection (P-value < 0.001).,"[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Awad', 'Affiliation': 'Anesthesia and Pain Management, Faculty of Medicine, Al-Fayoum Univeresity, Al-Fayoum, Egypt.'}, {'ForeName': 'Mina M', 'Initials': 'MM', 'LastName': 'Raouf', 'Affiliation': 'Faculty of medicine, ElMinia university, ElMinia, Egypt.'}, {'ForeName': 'Hany K', 'Initials': 'HK', 'LastName': 'Mikhail', 'Affiliation': 'Faculty of medicine, ElMinia university, ElMinia, Egypt.'}, {'ForeName': 'Sohair A', 'Initials': 'SA', 'LastName': 'Megalla', 'Affiliation': 'Faculty of medicine, ElMinia university, ElMinia, Egypt.'}, {'ForeName': 'Tamer Y', 'Initials': 'TY', 'LastName': 'Hamawy', 'Affiliation': 'Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Mohamed', 'Affiliation': 'Faculty of medicine, ElMinia university, ElMinia, Egypt.'}]","European journal of pain (London, England)",['10.1002/ejp.1748']
379,33550514,Impact of network performance on remote robotic-assisted endovascular interventions in porcine model.,"Remote robotic-assisted endovascular interventions require real-time control of the robotic system to conduct precise device navigation. The delay (latency) between the input command and the catheter response can be affected by factors such as network speed and distance. This study evaluated the effect of network latency on robotic-assisted endovascular navigation in three vascular beds using in-vivo experimental model. Three operators performed femoral, carotid, and coronary endovascular robotic navigation blinded from the hybrid room with the prototype remote-enabled CorPath GRX system in a porcine model. Navigation was performed to different targets with randomly assigned network latencies from 0 to 1000 ms. Outcome measurements included navigation success, navigation time, perceived lag (1 = imperceptible, 5 = too long), and procedural impact scored by the operators (1 = no impact, 5 = unacceptable). Robotic-assisted remote endovascular navigation was successful in all 65 cases (9 femoral, 38 external carotid, 18 coronary). Guidewire times were not significantly different across the simulated network latency times. Compared to 0 ms added latency, both the procedural impact and perceived lag scores were significantly higher when the added latency was 400 ms or greater (< 0.01). Remote endovascular intervention was feasible in all studied anatomic regions. Network latency of 400 ms or above is perceptible, although acceptable to operators, which suggests that remote robotic-assisted femoral, carotid or coronary arterial interventions should be performed with network latency below 400 ms to provide seamless remote device control.",2022,"Robotic-assisted remote endovascular navigation was successful in all 65 cases (9 femoral, 38 external carotid, 18 coronary).","['65 cases (9 femoral, 38 external carotid, 18 coronary', 'porcine model']","['Remote robotic-assisted endovascular interventions', 'network latency', 'Remote endovascular intervention', 'robotic-assisted endovascular navigation', 'remote robotic-assisted endovascular interventions', 'Robotic-assisted remote endovascular navigation']","['procedural impact and perceived lag scores', 'navigation success, navigation time, perceived lag (1\u2009=\u2009imperceptible, 5\u2009=\u2009too long), and procedural impact scored by the operators', 'delay (latency', 'Guidewire times']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0411282', 'cui_str': 'Endovascular radiological intervention'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}]",3.0,0.0819377,"Robotic-assisted remote endovascular navigation was successful in all 65 cases (9 femoral, 38 external carotid, 18 coronary).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Legeza', 'Affiliation': 'Department of Cardiovascular Surgery, Houston Methodist Hospital, 6550 Fannin St, Suite 1401, Houston, TX, 77030, USA. plegeza@houstonmethodist.org.'}, {'ForeName': 'Gavin W', 'Initials': 'GW', 'LastName': 'Britz', 'Affiliation': 'Department of Neurological Surgery and Neurological Institute, Houston Methodist Hospital, Houston, USA.'}, {'ForeName': 'Alpesh', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Houston Methodist DeBakey Cardiology Associates, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Kalyna', 'Initials': 'K', 'LastName': 'Sconzert', 'Affiliation': 'Corindus, A Siemens Healthineers Company, Waltham, MA, USA.'}, {'ForeName': 'John-Michael', 'Initials': 'JM', 'LastName': 'Sungur', 'Affiliation': 'Corindus, A Siemens Healthineers Company, Waltham, MA, USA.'}, {'ForeName': 'Ponraj', 'Initials': 'P', 'LastName': 'Chinnadurai', 'Affiliation': 'Siemens Medical Solutions USA Inc., Hoffman Estates, Illinois, USA.'}, {'ForeName': 'Kavya', 'Initials': 'K', 'LastName': 'Sinha', 'Affiliation': 'Department of Cardiovascular Surgery, Houston Methodist Hospital, 6550 Fannin St, Suite 1401, Houston, TX, 77030, USA.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Lumsden', 'Affiliation': 'Department of Cardiovascular Surgery, Houston Methodist Hospital, 6550 Fannin St, Suite 1401, Houston, TX, 77030, USA.'}]",Journal of robotic surgery,['10.1007/s11701-021-01196-6']
380,33555941,Addition of Lenalidomide to R-CHOP Improves Outcomes in Newly Diagnosed Diffuse Large B-Cell Lymphoma in a Randomized Phase II US Intergroup Study ECOG-ACRIN E1412.,"PURPOSE


Lenalidomide combined with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (R2CHOP) in untreated diffuse large B-cell lymphoma (DLBCL) has shown promising activity, particularly in the activated B-cell-like (ABC) subtype. Eastern Cooperative Oncology Group (ECOG)-ACRIN trial E1412 was a randomized phase II study comparing R2CHOP versus R-CHOP in untreated DLBCL.
PATIENTS AND METHODS


Patients with newly diagnosed DLBCL, stage II bulky-IV disease, International Prognostic Index (IPI) ≥ 2, and ECOG performance status ≤ 2 were eligible and randomly assigned 1:1 to R2CHOP versus R-CHOP for six cycles. Tumors were analyzed using the NanoString Lymph2Cx for cell of origin. The primary end point was progression-free survival (PFS) in all patients with the co-primary end point of PFS in ABC-DLBCL. Secondary end points included overall response rate (ORR), complete response (CR) rate, and overall survival (OS).
RESULTS


Three hundred forty-nine patients were enrolled; 280 patients (145 R2CHOP and 135 R-CHOP) were evaluable: 94 were ABC-DLBCL, 122 germinal center B-cell-like-DLBCL, 18 unclassifiable, and 46 unknowns. Baseline characteristics were well-balanced between arms, and the median age was 66 (range, 24-92); 70% of patients had stage IV disease; 34%, 43%, and 24% had IPI 2, 3, and 4 or 5, respectively. Myelosuppression was more common in the R2CHOP arm. The ORR and CR rate were 92% and 68% in R-CHOP and 97% ( P  = .06) and 73% ( P  = .43) in the R2CHOP arm, respectively. The median follow-up was 3.0 years; R2CHOP was associated with a 34% reduction in risk of progression or death versus R-CHOP (hazard ratio [HR], 0.66 95% CI, 0.43 to 1.01) and 3-year PFS of 73% versus 61%, one-sided  P  = .03, and an improvement in OS (83% and 75% at 3 years; HR, 0.67; one-sided  P  = .05). The PFS HR for R2CHOP was 0.67 for ABC-DLBCL, one-sided  P  = .1.
CONCLUSION


In this signal-seeking study, the addition of lenalidomide to R-CHOP (R2CHOP) improved outcomes in newly diagnosed DLBCL including patients with ABC-DLBCL.",2021,"The PFS HR for R2CHOP was 0.67 for ABC-DLBCL, one-sided  P  = .1.
","['≥ 2, and ECOG performance status ≤ 2 were eligible', 'Three hundred forty-nine patients were enrolled; 280 patients (145 R2CHOP and 135 R-CHOP) were evaluable: 94 were ABC-DLBCL, 122 germinal center B-cell-like-DLBCL, 18 unclassifiable, and 46 unknowns', 'Patients with newly diagnosed DLBCL, stage II bulky-IV disease, International Prognostic Index (IPI', 'untreated diffuse large B-cell lymphoma (DLBCL', 'Eastern Cooperative Oncology Group (ECOG)-ACRIN trial']","['R2CHOP versus R-CHOP', 'lenalidomide to R-CHOP (R2CHOP', 'rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (R2CHOP', 'Lenalidomide to R-CHOP']","['overall response rate (ORR), complete response (CR) rate, and overall survival (OS', 'OS', 'ORR and CR rate', 'Myelosuppression', 'risk of progression or death versus R-CHOP', 'PFS HR for R2CHOP', 'progression-free survival (PFS', '3-year PFS']","[{'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1333296', 'cui_str': 'Activated B-cell type diffuse large B-cell lymphoma'}, {'cui': 'C0282491', 'cui_str': 'Structure of germinal center of lymph node'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",349.0,0.188626,"The PFS HR for R2CHOP was 0.67 for ABC-DLBCL, one-sided  P  = .1.
","[{'ForeName': 'Grzegorz S', 'Initials': 'GS', 'LastName': 'Nowakowski', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Fangxin', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Department of Data Sciences, Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Scott', 'Affiliation': 'British Columbia Cancer Center for Lymphoid Cancer, Vancouver, Canada.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Macon', 'Affiliation': 'Division of Hematopathology, Mayo Clinic Rochester MN.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'King', 'Affiliation': 'Division of Hematopathology, Mayo Clinic Rochester MN.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Habermann', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wagner-Johnston', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Casulo', 'Affiliation': 'University of Rochester, NY.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Wade', 'Affiliation': 'Heartland NORP, Decatur IL.'}, {'ForeName': 'Gauri G', 'Initials': 'GG', 'LastName': 'Nagargoje', 'Affiliation': 'Marcy Hospital, Coon Rapids, MN.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Reynolds', 'Affiliation': 'Saint Joseph Mercy Hospital, Ann Arbor, MI.'}, {'ForeName': 'Jonathon B', 'Initials': 'JB', 'LastName': 'Cohen', 'Affiliation': 'Emory University-Winship Cancer Institute, Atlanta, GA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Khan', 'Affiliation': 'Fox Case Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Amengual', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Kristy L', 'Initials': 'KL', 'LastName': 'Richards', 'Affiliation': 'Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Little', 'Affiliation': 'National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': 'University of Rochester, NY.'}, {'ForeName': 'Lale', 'Initials': 'L', 'LastName': 'Kostakoglu', 'Affiliation': 'University of Virginia, Charlottesville VA.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Witzig', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01375']
381,33565206,"Autologous bone marrow-derived mesenchymal stromal cell therapy with early tacrolimus withdrawal: The randomized prospective, single-center, open-label TRITON study.","After renal transplantation, there is a need for immunosuppressive regimens which effectively prevent allograft rejection, while preserving renal function and minimizing side effects. From this perspective, mesenchymal stromal cell (MSC) therapy is of interest. In this randomized prospective, single-center, open-label trial, we compared MSCs infused 6 and 7 weeks after renal transplantation and early tacrolimus withdrawal with a control tacrolimus group. Primary end point was quantitative evaluation of interstitial fibrosis in protocol biopsies at 4 and 24 weeks posttransplant. Secondary end points included acute rejection, graft loss, death, renal function, adverse events, and immunological responses. Seventy patients were randomly assigned of which 57 patients were included in the final analysis (29 MSC; 28 controls). Quantitative progression of fibrosis failed to show benefit in the MSC group and GFR remained stable in both groups. One acute rejection was documented (MSC group), while subclinical rejection in week 24 protocol biopsies occurred in seven patients (four MSC; three controls). In the MSC group, regulatory T cell numbers were significantly higher compared to controls (p = .014, week 24). In conclusion, early tacrolimus withdrawal with MSC therapy was safe and feasible without increased rejection and with preserved renal function. MSC therapy is a potentially useful approach after renal transplantation.",2021,"In the MSC group, regulatory T-cell numbers were significantly higher compared to controls (P=.014, week 24).",['Seventy patients were randomly assigned of which 57 patients were included in the final analysis (29 MSC; 28 controls'],"['renal transplantation and early tacrolimus withdrawal with a control tacrolimus', 'MSC therapy', 'Autologous bone marrow derived mesenchymal stromal cell therapy with early tacrolimus withdrawal']","['subclinical rejection', 'regulatory T-cell numbers', 'acute rejection, graft loss, death, renal function, adverse events and immunological responses', 'safe and feasible without increased rejection and with preserved renal function', 'acute rejection', 'quantitative evaluation of interstitial fibrosis in protocol biopsies']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}]","[{'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0034384', 'cui_str': 'Quantitative Evaluation'}, {'cui': 'C3887486', 'cui_str': 'Interstitial fibrosis'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",70.0,0.0399029,"In the MSC group, regulatory T-cell numbers were significantly higher compared to controls (P=.014, week 24).","[{'ForeName': 'Marlies E J', 'Initials': 'MEJ', 'LastName': 'Reinders', 'Affiliation': 'Department of Internal Medicine (Nephrology) and Transplant Center, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Koen E', 'Initials': 'KE', 'LastName': 'Groeneweg', 'Affiliation': 'Department of Internal Medicine (Nephrology) and Transplant Center, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Sanne H', 'Initials': 'SH', 'LastName': 'Hendriks', 'Affiliation': 'Department of Immunology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Jonna R', 'Initials': 'JR', 'LastName': 'Bank', 'Affiliation': 'Department of Internal Medicine (Nephrology) and Transplant Center, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Geertje J', 'Initials': 'GJ', 'LastName': 'Dreyer', 'Affiliation': 'Department of Internal Medicine (Nephrology) and Transplant Center, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Aiko P J', 'Initials': 'APJ', 'LastName': 'de Vries', 'Affiliation': 'Department of Internal Medicine (Nephrology) and Transplant Center, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'van Pel', 'Affiliation': 'Department of Immunology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Roelofs', 'Affiliation': 'Department of Immunology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Volkert A L', 'Initials': 'VAL', 'LastName': 'Huurman', 'Affiliation': 'Department of Transplant Surgery and Transplant Center, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Meij', 'Affiliation': 'Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Dirk J A R', 'Initials': 'DJAR', 'LastName': 'Moes', 'Affiliation': 'Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Willem E', 'Initials': 'WE', 'LastName': 'Fibbe', 'Affiliation': 'Department of Immunology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Frans H J', 'Initials': 'FHJ', 'LastName': 'Claas', 'Affiliation': 'Department of Immunology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Dave L', 'Initials': 'DL', 'LastName': 'Roelen', 'Affiliation': 'Department of Immunology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'van Kooten', 'Affiliation': 'Department of Internal Medicine (Nephrology) and Transplant Center, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kers', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Heidt', 'Affiliation': 'Department of Immunology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Ton J', 'Initials': 'TJ', 'LastName': 'Rabelink', 'Affiliation': 'Department of Internal Medicine (Nephrology) and Transplant Center, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Johan W', 'Initials': 'JW', 'LastName': 'de Fijter', 'Affiliation': 'Department of Internal Medicine (Nephrology) and Transplant Center, Leiden University Medical Center, Leiden, the Netherlands.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16528']
382,33568383,Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study.,"BACKGROUND


Current anemia therapies for patients with non-dialysis-dependent CKD may require injection and medical visits. Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulates erythropoiesis and improves iron homeostasis.
METHODS


In this double-blind phase 3 study, we randomized patients with non-dialysis-dependent CKD stages 3-5 and hemoglobin <10.0 g/dl (1:1) to thrice-weekly 70-mg oral roxadustat or placebo. Doses were titrated throughout the study based on hemoglobin levels. The primary efficacy end point was mean change from baseline in hemoglobin averaged over weeks 28-52 versus placebo, irrespective of rescue therapy use. We assessed patients for adverse events.
RESULTS


The study included 2781 patients, 1393 who received roxadustat and 1388 who received placebo. Mean baseline hemoglobin was 9.1 g/dl for both groups. The mean change in hemoglobin from baseline was 1.75 g/dl (95% confidence interval [95% CI], 1.68 to 1.81) with roxadustat versus 0.40 g/dl (95% CI, 0.33 to 0.47) with placebo, ( P <0.001). Among 411 patients with baseline elevated high-sensitivity C-reactive protein, mean change in hemoglobin from baseline was 1.75 g/dl (95% CI, 1.58 to 1.92) with roxadustat versus 0.62 g/dl (95% CI, 0.44 to 0.80) with placebo, ( P <0.001). Roxadustat reduced the risk of red blood cell transfusion by 63% (hazard ratio, 0.37; 95% CI, 0.30 to 0.44). The most common adverse events with roxadustat and placebo, respectively, were ESKD (21.0% versus 20.5%), urinary tract infection (12.8% versus 8.0%), pneumonia (11.9% versus 9.4%), and hypertension (11.5% versus 9.1%).
CONCLUSIONS


Roxadustat effectively increased hemoglobin in patients with non-dialysis-dependent CKD and reduced the need for red blood cell transfusion, with an adverse event profile comparable to that of placebo.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With CKD, Not on Dialysis, NCT02174627.",2021,"Roxadustat reduced the risk of red blood cell transfusion by 63% (hazard ratio, 0.37; 95% CI, 0.30 to 0.44).","['Patients with CKD Not on Dialysis', 'patients with non-dialysis-dependent CKD stages 3-5 and hemoglobin <10.0 g/dl (1:1) to', '411 patients with baseline elevated high', 'patients with non-dialysis-dependent CKD may require injection and medical visits', '2781 patients, 1393 who received roxadustat and 1388 who received']","['placebo', 'thrice-weekly 70-mg oral roxadustat or placebo']","['sensitivity C-reactive protein, mean change in hemoglobin', 'Mean baseline hemoglobin', 'hemoglobin', 'pneumonia', 'mean change from baseline in hemoglobin', 'hypertension', 'urinary tract infection', 'risk of red blood cell transfusion', 'mean change in hemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}]",2781.0,0.538988,"Roxadustat reduced the risk of red blood cell transfusion by 63% (hazard ratio, 0.37; 95% CI, 0.30 to 0.44).","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fishbane', 'Affiliation': 'Department of Medicine, Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, New York sfishbane@northwell.edu.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'El-Shahawy', 'Affiliation': 'Department of Medicine, Keck-University of Southern California School of Medicine, Los Angeles, California.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pecoits-Filho', 'Affiliation': 'School of Medicine, Pontifical Catholic University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Bui Pham', 'Initials': 'BP', 'LastName': 'Van', 'Affiliation': 'Department of Medicine, Pham Ngoc Thach University of Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Houser', 'Affiliation': 'Global Medicines Development, Biopharmaceuticals Research & Development, AstraZeneca Gaithersburg, Gaithersburg, Maryland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Frison', 'Affiliation': 'Biostatistics, Biopharmaceuticals Research & Development, AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Dustin J', 'Initials': 'DJ', 'LastName': 'Little', 'Affiliation': 'Global Medicines Development, Biopharmaceuticals Research & Development, AstraZeneca Gaithersburg, Gaithersburg, Maryland.'}, {'ForeName': 'Nicolas J', 'Initials': 'NJ', 'LastName': 'Guzman', 'Affiliation': 'Global Medicines Development, Biopharmaceuticals Research & Development, AstraZeneca Gaithersburg, Gaithersburg, Maryland.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Pergola', 'Affiliation': 'Renal Associates PA, San Antonio, Texas.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020081150']
383,33569725,Optimal surveillance interval after piecemeal endoscopic mucosal resection for large colorectal neoplasia: a multicenter randomized controlled trial.,"BACKGROUND AND AIMS


Colorectal neoplastic lesions (≥ 20 mm) are commonly treated via piecemeal endoscopic mucosal resection (p-EMR) but have a high rate of local recurrence. We aimed to clarify the optimal surveillance interval after p-EMR for these neoplasias.
METHODS


In this multicenter (15 participating institutions) prospective, randomized trial, 180 patients recruited over a 4-year period and were classified based on tumor location, tumor diameter, histological diagnosis, institution, and number of resected specimens. The patients underwent curative p-EMR followed by scheduled surveillance colonoscopy at 3, 6, 12, and 24 months after p-EMR (group A; n = 90) or at 6, 12, and 24 months after p-EMR (group B; n = 90). The primary endpoint was cumulative local recurrence at 6 months after p-EMR. Secondary endpoints included local recurrence and the cumulative surgical resection rate of recurrent tumors during the 24-month follow-up period.
RESULTS


The median tumor diameter was 25 mm (IQR 20-30). Six months after p-EMR, 12 and 6 local recurrences were noted in groups A and B, which corresponded to 13 and 8 recurrences, respectively, during the 24-month surveillance period. The primary and secondary endpoints of recurrence were not significantly different between the groups on either intention-to-treat or per-protocol analysis; no surgery case was observed in group B when a strict surveillance protocol of 6-, 12-, and 24-month follow-up post-EMR was followed.
CONCLUSIONS


For patients who underwent p-EMR for neoplastic lesions, additional postprocedural 3-month surveillance did not show superior results in detecting recurrence compared with a 6-month surveillance interval.
CLINICAL TRIAL REGISTRATION


UMIN000015740.",2022,"The primary and secondary endpoints of recurrence were not significantly different between the groups on either intention-to-treat or per-protocol analysis; no surgery case was observed in group B when a strict surveillance protocol of 6-, 12-, and 24-month follow-up post-EMR was followed.
","['large colorectal neoplasia', '180 patients recruited over a 4-year period and were classified based on tumor location, tumor diameter, histological diagnosis, institution, and number of resected specimens']","['curative p-EMR followed by scheduled surveillance colonoscopy', 'piecemeal endoscopic mucosal resection']","['recurrence', 'local recurrence and the cumulative surgical resection rate of recurrent tumors during the 24-month follow-up period', 'median tumor diameter', 'intention-to-treat or per-protocol analysis; no surgery case', 'cumulative local recurrence']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1700928', 'cui_str': 'Strip Biopsy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0521158', 'cui_str': 'Recurrent tumor'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",180.0,0.159845,"The primary and secondary endpoints of recurrence were not significantly different between the groups on either intention-to-treat or per-protocol analysis; no surgery case was observed in group B when a strict surveillance protocol of 6-, 12-, and 24-month follow-up post-EMR was followed.
","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Endoscopy Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Endoscopy Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Hori', 'Affiliation': 'Department of Endoscopy, NHO Shikoku Cancer Center, Matsuyama, Ehime, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Ikematsu', 'Affiliation': 'Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Department of Gastroenterology, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Han-Mo', 'Initials': 'HM', 'LastName': 'Chiu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Kiriyama', 'Affiliation': 'Department of Surgery, Gunma Chuo Hospital, Maebashi, Gunma, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Michida', 'Affiliation': 'Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Kinichi', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Department of Gastroenterology, Saku Central Hospital, Nagano, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Gastroenterology, Juntendo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Gastroenterology Center, Hanwa Sumiyoshi General Hospital, Osaka, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Chino', 'Affiliation': 'Gastroenterological Medicine, Cancer Institute Hospital, Ariake, Tokyo, Japan.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Fukuzawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology, Tochigi Cancer Center, Utsunomiya, Tochigi, Japan.'}, {'ForeName': 'Kazutoshi', 'Initials': 'K', 'LastName': 'Fukase', 'Affiliation': 'Yamagata Prefectural Central Hospital, Yamagata, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Matsuda', 'Affiliation': 'Endoscopy Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Murakami', 'Affiliation': 'Department of Medical Statistics, Toho University, Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Endoscopy Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. ytsaito@ncc.go.jp.'}]",Surgical endoscopy,['10.1007/s00464-021-08311-6']
384,33566173,Involuntary reflexive pelvic floor muscle training in addition to standard training versus standard training alone for women with stress urinary incontinence: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS


Although involuntary reflexive pelvic floor muscle contractions seem crucial during stress urinary incontinence-provoking situations, hitherto existing guidelines feature voluntary pelvic floor muscle training only. Two pelvic floor muscle protocols were compared regarding their effect on stress urinary incontinence in women: one focusing on standard physiotherapy with voluntary pelvic floor muscle training, the other additionally including involuntary reflexive pelvic floor muscle training.
METHODS


This study was designed as a triple-blind prospective randomized controlled trial with women suffering from stress urinary incontinence with two physiotherapy intervention groups (control group: standard physiotherapy, n = 48, experimental group: standard physiotherapy plus involuntary reflexive pelvic floor muscle training triggered by whole-body movements such as jumps n = 48). Both interventions lasted 16 weeks (9 personal physiotherapy consultations and 78 home training sessions). Group differences and development over time were analyzed concerning the primary outcome International Consultation on Incontinence Modular Questionnaire Urinary Incontinence short form (ICIQ-UIsf) by mixed effect regression models.
RESULTS


The ICIQ-UIsf score decreased significantly over time for both groups by about 3 points from about 10 to about 7 points with no group differences at any point in time.
DISCUSSION


This trial did not find any additional benefit for stress urinary incontinence by adding involuntary reflexive pelvic floor muscle training to standard training. Both training protocols showed similar clinically relevant improvements; however, there was still moderate incontinence after interventions. Future studies should test and apply pelvic floor muscle function-oriented training methods for pelvic floor muscle hypertrophy, intramuscular coordination, and power, which are more in line with conventional skeletal muscle training, i.e., performed with higher intensities and workout.",2022,This trial did not find any additional benefit for stress urinary incontinence by adding involuntary reflexive pelvic floor muscle training to standard training.,"['women with stress urinary incontinence', 'women', 'women suffering from stress urinary incontinence with two']","['Involuntary reflexive pelvic floor muscle training', 'involuntary reflexive pelvic floor muscle training to standard training', 'physiotherapy intervention groups (control group: standard physiotherapy, n\u2009=\u200948, experimental group: standard physiotherapy plus involuntary reflexive pelvic floor muscle training triggered by whole-body movements such as jumps n\u2009=\u200948', 'standard physiotherapy with voluntary pelvic floor muscle training, the other additionally including involuntary reflexive pelvic floor muscle training', 'standard training versus standard training alone']","['ICIQ-UIsf score', 'Incontinence Modular Questionnaire Urinary Incontinence short form (ICIQ-UIsf', 'stress urinary incontinence']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]",2.0,0.0323562,This trial did not find any additional benefit for stress urinary incontinence by adding involuntary reflexive pelvic floor muscle training to standard training.,"[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Luginbuehl', 'Affiliation': 'Department of Health Professions, Division of Physiotherapy, Bern University of Applied Sciences, Murtenstrasse 10, 3008, Bern, Switzerland. helena.luginbuehl@bfh.ch.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Lehmann', 'Affiliation': 'Department of Physiotherapy, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Koenig', 'Affiliation': 'Department of Health Professions, Division of Physiotherapy, Bern University of Applied Sciences, Murtenstrasse 10, 3008, Bern, Switzerland.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Kuhn', 'Affiliation': ""Urogynaecology, Bern University Hospital and University of Bern, Women's Hospital, Bern, Switzerland.""}, {'ForeName': 'Reto', 'Initials': 'R', 'LastName': 'Buergin', 'Affiliation': 'Department of Health Professions, Division of Nursing, Bern University of Applied Sciences, Bern, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Radlinger', 'Affiliation': 'Department of Health Professions, Division of Physiotherapy, Bern University of Applied Sciences, Murtenstrasse 10, 3008, Bern, Switzerland.'}]",International urogynecology journal,['10.1007/s00192-021-04701-5']
385,33568491,An mHealth Intervention for Pregnancy Prevention for LGB Teens: An RCT.,"BACKGROUND


Although lesbian, gay, bisexual and other sexual minority (LGB+) girls are more likely than heterosexual girls to be pregnant during adolescence, relevant pregnancy prevention programming is lacking.
METHODS


A national randomized controlled trial was conducted with 948 14- to 18-year-old cisgender LGB+ girls assigned to either Girl2Girl or an attention-matched control group. Participants were recruited on social media between January 2017 and January 2018 and enrolled over the telephone. Between 5 and 10 text messages were sent daily for 7 weeks. Both experimental arms ended with a 1-week booster delivered 12 weeks subsequently.
RESULTS


A total of 799 (84%) participants completed the intervention end survey. Participants were, on average, 16.1 years of age (SD: 1.2 years). Forty-three percent were minority race; 24% were Hispanic ethnicity. Fifteen percent lived in a rural area and 29% came from a low-income household. Girl2Girl was associated with significantly higher rates of condom-protected sex (adjusted odds ratio [aOR] = 1.48,  P  < .001), current use of birth control other than condoms (aOR = 1.60,  P  = .02), and intentions to use birth control among those not currently on birth control (aOR = 1.93,  P  = .001). Differences in pregnancy were clinically but not statistically significant (aOR = 0.43,  P  = .23). Abstinence (aOR = 0.82,  P  = .34), intentions to be abstinent (aOR = 0.95,  P  = .77), and intentions to use condoms (aOR = 1.09,  P  = .59) were similar by study arm.
CONCLUSIONS


Girl2Girl appears to be associated with increases in pregnancy preventive behaviors for LGB+ girls, at least in the short-term. Comprehensive text messaging-based interventions could be used more widely to promote adolescent sexual health behaviors across the United States.",2021,"Differences in pregnancy were clinically but not statistically significant (aOR = 0.43,  P  = .23).","['Forty-three percent were minority race; 24% were Hispanic ethnicity', '948 14- to 18-year-old cisgender LGB+ girls assigned to either', 'A total of 799 (84%) participants completed the intervention end survey', 'LGB Teens', 'Participants were, on average, 16.1 years of age (SD: 1.2 years', 'Fifteen percent lived in a rural area and 29% came from a low-income household', 'Participants were recruited on social media between January 2017 and January 2018 and enrolled over the telephone']","['mHealth Intervention', 'Girl2Girl or an attention-matched control group']","['pregnancy preventive behaviors', 'intentions to use condoms', 'intentions to use birth control', 'Abstinence', 'current use of birth control']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C1634625', 'cui_str': '% live'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]",,0.133141,"Differences in pregnancy were clinically but not statistically significant (aOR = 0.43,  P  = .23).","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ybarra', 'Affiliation': 'Center for Innovative Public Health Research, San Clemente, California.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Goodenow', 'Affiliation': 'Independent Consultant, Northborough, Massachusetts.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rosario', 'Affiliation': 'City College and Graduate Center, The City University of New York, New York, New York; and.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Saewyc', 'Affiliation': 'School of Nursing, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Prescott', 'Affiliation': 'Center for Innovative Public Health Research, San Clemente, California.'}]",Pediatrics,['10.1542/peds.2020-013607']
386,33575683,"Video-Counseling Intervention to Address HIV Care Engagement, Mental Health, and Substance Use Challenges: A Pilot Randomized Clinical Trial for Youth and Young Adults Living with HIV.","Background:  Substance use and mental health are two barriers to engagement in care and antiretroviral therapy (ART) adherence among youth and young adults living with HIV (YLWH). The consequences of suboptimal adherence in YLWH are increased risk of HIV transmission and a future generation of immunodeficient adults with drug-resistant virus.  Methods:  The Youth to Telehealth and Texting for Engagement in Care (Y2TEC) study was a pilot randomized crossover trial that examined the feasibility and acceptability of a novel video-counseling series and accompanying text messages aimed at mental health, substance use, and HIV care engagement for YLWH. The intervention consisted of twelve 20-30-min weekly video-counseling sessions focused on identifying and addressing barriers to HIV care, mental health, and substance use challenges. Participants completed quantitative surveys at baseline, 4 months, and 8 months. Feasibility and acceptability were evaluated using prespecified benchmarks.  Results:  Fifty YLWH aged 18-29 years living in the San Francisco Bay Area were enrolled. Eighty-six percent and 75% of participants were retained at 4 and 8 months, respectively. A total of 455 (76%) video-counseling sessions were completed. In 82% of sessions, participants responded that they strongly agreed/agreed with this statement: ""I felt heard, understood, and respected by the counselor."" In 81% of sessions, participants responded that they strongly agreed/agreed with this statement: ""Overall, today's session was right for me."" At baseline, among participants reporting mental health challenges, only 10% noted having ever received mental health services, and among those who reported substance use challenges, ∼19% reported ever receiving substance use services. After 4 months of the Y2TEC intervention, participants reported slightly higher ART adherence and HIV knowledge, decreased depression and anxiety, and reduced stigma related to mental health and substance use.  Conclusions:  The Y2TEC intervention using video-counseling and text messaging was feasible and acceptable for YLWH. ClinicalTrials.gov ID: NCT03681145.",2021,"After 4 months of the Y2TEC intervention, participants reported slightly higher ART adherence and HIV knowledge, decreased depression and anxiety, and reduced stigma related to mental health and substance use.  ","['Fifty YLWH aged 18-29 years living in the San Francisco Bay Area were enrolled', 'youth and young adults living with HIV (YLWH', 'Youth and Young Adults Living with HIV']","['Y2TEC intervention', 'Video-Counseling Intervention', 'novel video-counseling series and accompanying text messages', 'Y2TEC intervention using video-counseling and text messaging', 'Telehealth and Texting for Engagement in Care']","['ART adherence and HIV knowledge, decreased depression and anxiety, and reduced stigma related to mental health and substance use', 'Feasibility and acceptability', 'mental health services']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0580931', 'cui_str': 'In care'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}]",455.0,0.192686,"After 4 months of the Y2TEC intervention, participants reported slightly higher ART adherence and HIV knowledge, decreased depression and anxiety, and reduced stigma related to mental health and substance use.  ","[{'ForeName': 'Parya', 'Initials': 'P', 'LastName': 'Saberi', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Caravella', 'Initials': 'C', 'LastName': 'McCuistian', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Agnew', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Angie R', 'Initials': 'AR', 'LastName': 'Wootton', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Dominique A', 'Initials': 'DA', 'LastName': 'Legnitto Packard', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Dawson-Rose', 'Affiliation': 'Department of Community Health Systems, School of Nursing, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Mallory O', 'Initials': 'MO', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}]",Telemedicine reports,['10.1089/tmr.2020.0014']
387,33604801,Effect of exercise on sleep and cardiopulmonary parameters in patients with pulmonary artery hypertension.,"BACKGROUND


Pulmonary arterial hypertension (PAH) is considered to be a rare progressive disease resulting from restricted flow through the pulmonary arterial circulation resulting ultimately in right-sided heart failure. Most patients with PAH suffer from sleep disorders, reduced aerobic fitness, and mortality risk despite optimized medical treatment. This study investigated the effect of 12 weeks of aerobic training on sleep quality, sleep efficiency, right ventricular systolic pressure (RVSP), and aerobic fitness in patients with PAH.
METHODS


Thirty patients with PAH were randomized to two equal groups, training group (A) and control group (B). The Pittsburg sleep quality index (PSQI) questionnaire and a wrist-worn actigraph were used for the assessment of sleep quality and sleep efficiency respectively. RVSP was measured using echocardiography. Cardiopulmonary exercise testing (CPET) assessed maximal heart rate and VO2max. All were measured before and after the study period for both groups. Exercise training was conducted on a bicycle ergometer as an individually-tailored moderate-intensity aerobic training session (60 to 70% of the maximal heart rate reached during the initial exercise test) for 30 to 45 min/day, 3 sessions/week for 12 weeks (36 sessions).
RESULTS


Sleep scores and RVSP showed significant reductions and VO2max-representing the aerobic fitness-showed a significant increase in the group (A) compared with group (B).
CONCLUSION


These results suggest that aerobic training has a positive effect on three risk factors for mortality in patients with PAH, namely sleep quality, decline in exercise capacity, and right ventricular remodeling.
CLINICAL TRIALS REGISTRATION


Clinical trial registered in ClinicalTrials.gov , ID: NCT04337671.",2021,"RESULTS


Sleep scores and RVSP showed significant reductions and VO2max-representing the aerobic fitness-showed a significant increase in the group (A) compared with group (B).
","['patients with PAH', 'patients with pulmonary artery hypertension', 'Thirty patients\xa0with PAH', 'patients with\xa0PAH']","['Cardiopulmonary exercise testing (CPET', 'exercise', 'aerobic training', 'bicycle ergometer as an individually-tailored moderate-intensity aerobic training\xa0session', 'Exercise training']","['sleep quality, sleep efficiency, right ventricular systolic pressure (RVSP), and aerobic fitness', 'maximal heart\xa0rate and VO2max', 'sleep and cardiopulmonary parameters', 'RVSP', 'Pittsburg sleep quality index (PSQI) questionnaire and a wrist-worn actigraph', 'aerobic fitness, and mortality risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0180749', 'cui_str': 'Bicycle ergometer'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0456181', 'cui_str': 'Right ventricular systolic pressure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0261602,"RESULTS


Sleep scores and RVSP showed significant reductions and VO2max-representing the aerobic fitness-showed a significant increase in the group (A) compared with group (B).
","[{'ForeName': 'Hady', 'Initials': 'H', 'LastName': 'Atef', 'Affiliation': 'Faculty of physical therapy, Cairo University, Cairo, Egypt. hady612@hotmail.com.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Abdeen', 'Affiliation': 'Faculty of physical therapy, Cairo University, Cairo, Egypt.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02286-9']
388,33584044,"Comparison of Safety, Efficacy, Patient Compliance and Cost-Effectiveness of Transdermal, Oral and Intramuscular Diclofenac for Pain Control Following Oral Surgical Procedures.","Purpose


To evaluate transdermal diclofenac in terms of analgesic efficacy, safety, compliance and cost-effectiveness and to compare it with oral tablets and intramuscular (IM) injections following surgical removal of impacted mandibular third molars.
Subjects and Methods


A prospective, single-centre, multi-arm parallel, randomized study on subjects undergoing extraction of impacted mandibular third molars was conducted between January 2016 and December 2017. The study included 90 participants, 30 in each group. Participants received the standard once daily (OD) dosages of diclofenac in each group for three post-operative days and were advised to consume paracetamol 500 mg as rescue analgesics if the pain was not alleviated. Outcome measures such as demographics, duration of surgery, post-operative pain, the number of rescue analgesics taken, adverse drug reactions experienced and overall global assessment for three post-operative days were recorded by the participants on a questionnaire.
Results


Transdermal and oral forms achieved similar analgesia on all 3 days. Injectable diclofenac had significantly better pain control on the second and third post-operative days compared to tablets and on the third day compared to transdermal diclofenac. A higher number of rescue analgesics was consumed in oral group on day 1. Gastritis and vomiting were seen in 36.66% and 10% cases, respectively, in oral group. 100% of those in IM group had pain on injection. 6.6% complained of dry skin due to patch, while 3.33% had rash and pruritus. Transdermal group had better overall global assessment by patients with 16.67%, 46.67% and 20% participants reporting excellent, very good and good pain control, respectively. The cost in INR was maximum for the transdermal group.
Conclusion


Transdermal diclofenac is an excellent alternative to oral and parenteral routes of drug administration in oral surgical procedures with adequate analgesic efficacy, good compliance and fewer side effects.",2021,Injectable diclofenac had significantly better pain control on the second and third post-operative days compared to tablets and on the third day compared to transdermal diclofenac.,"['Pain Control Following Oral Surgical Procedures', 'surgical removal of impacted mandibular third molars', '90 participants, 30 in each group', 'subjects undergoing extraction of impacted mandibular third molars was conducted between January 2016 and December 2017']","['diclofenac', 'Injectable diclofenac', 'oral tablets and intramuscular (IM) injections', 'Transdermal, Oral and Intramuscular Diclofenac', 'paracetamol', 'transdermal diclofenac', 'Transdermal diclofenac']","['pain on injection', 'Gastritis and vomiting', 'overall global assessment', 'demographics, duration of surgery, post-operative pain, the number of rescue analgesics taken, adverse drug reactions experienced and overall global assessment for three post-operative days', 'cost in INR', 'analgesic efficacy, safety, compliance and cost-effectiveness', 'pain control', 'rash and pruritus', 'Safety, Efficacy, Patient Compliance and Cost-Effectiveness']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0524861', 'cui_str': 'Oral surgery'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0993159', 'cui_str': 'Oral tablet'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0017152', 'cui_str': 'Gastritis'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}]",90.0,0.0424232,Injectable diclofenac had significantly better pain control on the second and third post-operative days compared to tablets and on the third day compared to transdermal diclofenac.,"[{'ForeName': 'Dipti', 'Initials': 'D', 'LastName': 'Samal', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha India.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Mishra', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha India.'}, {'ForeName': 'Brundabati', 'Initials': 'B', 'LastName': 'Meher', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha India.'}, {'ForeName': 'Indu Bhusan', 'Initials': 'IB', 'LastName': 'Kar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha India.'}, {'ForeName': 'Rosalin', 'Initials': 'R', 'LastName': 'Kar', 'Affiliation': 'Department of Prosthetic Dentistry, SCB Dental College and Hospital, Cuttack, Odisha India.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Saipooja', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-019-01260-7']
389,33584043,Abdominal Dermis-Fat Graft Versus Conventional Temporalis Myofascial Flap Interposition in Temporomandibular Joint Ankylosis: A Prospective Clinical Comparative Study.,"Introduction


Temporomandibular joint (TMJ) ankylosis is an extremely disabling condition with almost complete inability to open the jaws causing difficulty in chewing, speech, poor oral hygiene and cosmetic disfigurement. Temporalis myofascial flap still remains the most common interpositional material used; however, patients usually complain of pain during movement, unesthetic bulging in the temporal region and trismus due to scar contracture. The main aim of the study was to evaluate the efficacy of abdominal dermis-fat graft and compare it with temporalis myofascial flap as to see which of the two grafts offers more advantages and provides better postoperative results following TMJ ankylosis surgery.
Materials and Methods


A total of 30 diagnosed cases of TMJ ankylosis were randomly divided into two groups of 15 patients each. All the patients underwent TMJ ankylosis release under general anesthesia followed by abdominal dermis-fat interposition in Group A and temporalis muscle in Group B. The patients were assessed for pre-operative and postoperative mouth opening (immediate and 6 month postoperative), pain during physiotherapy, donor and surgical site complications and recurrence of ankylosis.
Results


The mean maximum inter-incisal opening in dermis-fat group was significantly higher than temporalis group both at immediate and 6 month postoperative periods ( p  = 0.041, 0.001). Physiotherapy was less painful in dermis-fat group than in temporalis group, and the differences in VAS scores among the 2 groups showed high statistical significance ( p  < 0.001). Hypertrophic scar developed at the donor site in 2 patients in dermis-fat group; however, it was located below the beltline and hardly noticeable. A total of 9 patients (4 in Group A and 5 in Group B) developed temporary facial nerve weakness, and no case of re-ankylosis was noted in either group.
Conclusion


Dermis-fat graft in temporomandibular joint ankylosis showed better results than conventional temporalis myofascial flap in terms of postoperative mouth opening, physiotherapy and jaw function with esthetically acceptable results.",2021,"The mean maximum inter-incisal opening in dermis-fat group was significantly higher than temporalis group both at immediate and 6 month postoperative periods ( p  = 0.041, 0.001).","['Temporomandibular Joint Ankylosis', '30 diagnosed cases of TMJ ankylosis']","['Conventional Temporalis Myofascial Flap Interposition', 'abdominal dermis-fat graft', 'conventional temporalis myofascial flap', 'Abdominal Dermis-Fat Graft', 'TMJ ankylosis release under general anesthesia followed by abdominal dermis-fat interposition in Group A and temporalis muscle in Group B']","['temporary facial nerve weakness', 'pre-operative and postoperative mouth opening (immediate and 6\xa0month postoperative), pain during physiotherapy, donor and surgical site complications and recurrence of ankylosis', 'mean maximum inter-incisal opening', 'Hypertrophic scar', 'VAS scores']","[{'cui': 'C2931375', 'cui_str': 'Ankylosis of temporomandibular joint'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C2931375', 'cui_str': 'Ankylosis of temporomandibular joint'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0039487', 'cui_str': 'Structure of temporalis muscle'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0015462', 'cui_str': 'Facial nerve structure'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0003090', 'cui_str': 'Ankylosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C4040028', 'cui_str': 'Incisal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0388244,"The mean maximum inter-incisal opening in dermis-fat group was significantly higher than temporalis group both at immediate and 6 month postoperative periods ( p  = 0.041, 0.001).","[{'ForeName': 'Mubashir', 'Initials': 'M', 'LastName': 'Younis', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Elite Mission Hospital, Thrissur, Kerala India.'}, {'ForeName': 'Ajaz Ahmed', 'Initials': 'AA', 'LastName': 'Shah', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital Srinagar, Srinagar, Jammu and Kashmir India.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Hassan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital Srinagar, Srinagar, Jammu and Kashmir India.'}, {'ForeName': 'Muneet', 'Initials': 'M', 'LastName': 'Kapoor', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital Srinagar, Srinagar, Jammu and Kashmir India.'}, {'ForeName': 'Abina', 'Initials': 'A', 'LastName': 'Rashid', 'Affiliation': 'SKIMS Medical College and Hospital, Srinagar, Jammu and Kashmir India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01455-3']
390,33587894,Circulating tumour DNA in patients with advanced melanoma treated with dabrafenib or dabrafenib plus trametinib: a clinical validation study.,"BACKGROUND


Melanoma lacks validated blood-based biomarkers for monitoring and predicting treatment efficacy. Cell-free circulating tumour DNA (ctDNA) is a promising biomarker; however, various detection methods have been used, and, to date, no large studies have examined the association between serial changes in ctDNA and survival after BRAF, MEK, or BRAF plus MEK inhibitor therapy. We aimed to evaluate whether baseline ctDNA concentrations and kinetics could predict survival outcomes.
METHODS


In this clinical validation study, we used analytically validated droplet digital PCR assays to measure BRAF V600 -mutant ctDNA in pretreatment and on-treatment plasma samples from patients aged 18 years or older enrolled in two clinical trials. COMBI-d (NCT01584648) was a double-blind, randomised phase 3 study of dabrafenib plus trametinib versus dabrafenib plus placebo in previously untreated patients with BRAF V600  mutation-positive unresectable or metastatic melanoma. Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. COMBI-MB (NCT02039947) was an open-label, non-randomised, phase 2 study evaluating dabrafenib plus trametinib in patients with BRAF V600  mutation-positive metastatic melanoma and brain metastases. Patients in cohort A of COMBI-MB had asymptomatic brain metastases, no previous local brain-directed therapy, and an ECOG performance status of 0 or 1. Biomarker analysis was a prespecified exploratory endpoint in both trials and performed in the intention-to-treat populations in COMBI-d and COMBI-MB. We investigated the association between mutant copy number (baseline or week 4 or zero conversion status) and efficacy endpoints (progression-free survival, overall survival, and best overall response). We used Cox models, Kaplan-Meier plots, and log-rank tests to explore the association of pretreatment ctDNA concentrations with progression-free survival and overall survival. The effect of additional prognostic variables such as lactate dehydrogenase was also investigated in addition to the mutant copy number.
FINDINGS


In COMBI-d, pretreatment plasma samples were available from 345 (82%) of 423 patients and on-treatment (week 4) plasma samples were available from 224 (53%) of 423 patients. In cohort A of COMBI-MB, pretreatment and on-treatment samples were available from 38 (50%) of 76 patients with intracranial and extracranial metastatic melanoma. ctDNA was detected in pretreatment samples from 320 (93%) of 345 patients (COMBI-d) and 34 (89%) of 38 patients (COMBI-MB). When assessed as a continuous variable, elevated baseline BRAF V600  mutation-positive ctDNA concentration was associated with worse overall survival outcome (hazard ratio [HR] 1·13 [95% CI 1·09-1·18], p<0·0001 by univariate analysis), independent of treatment group and baseline lactate dehydrogenase concentrations (1·08 [1·03-1·13], p=0·0020), in COMBI-d. A ctDNA cutoff point of 64 copies per mL of plasma stratified patients enrolled in COMBI-d as high risk or low risk with respect to survival outcomes (HR 1·74 [95% CI 1·37-2·21], p<0·0001 for progression-free survival; 2·23 [1·73-2·87], p<0·0001 for overall survival) and was validated in the COMBI-MB cohort (3·20 [1·39-7·34], p=0·0047 for progression-free survival; 2·94 [1·18-7·32], p=0·016 for overall survival). In COMBI-d, undetectable ctDNA at week 4 was significantly associated with extended progression-free and overall survival, particularly in patients with elevated lactate dehydrogenase concentrations (HR 1·99 [95% CI 1·08-3·64], p=0·027 for progression-free survival; 2·38 [1·24-4·54], p=0·0089 for overall survival).
INTERPRETATION


Pretreatment and on-treatment BRAF V600 -mutant ctDNA measurements could serve as independent, predictive biomarkers of clinical outcome with targeted therapy.
FUNDING


Novartis.",2021,"In COMBI-d, undetectable ctDNA at week 4 was significantly associated with extended progression-free and overall survival, particularly in patients with elevated lactate dehydrogenase concentrations (HR 1·99 [95% CI 1·08-3·64], p=0·027 for progression-free survival; 2·38 [1·24-4·54], p=0·0089 for overall survival).
","['1·13', 'previously untreated patients with BRAF V600  mutation-positive unresectable or metastatic melanoma', 'patients with advanced melanoma treated with', '76 patients with intracranial and extracranial metastatic melanoma', 'patients aged 18 years or older enrolled in two clinical trials', 'Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', 'patients with BRAF V600  mutation-positive metastatic melanoma and brain metastases']","['dabrafenib or dabrafenib plus trametinib', 'dabrafenib plus trametinib versus dabrafenib plus placebo']","['extended progression-free and overall survival', 'survival outcomes', 'elevated lactate dehydrogenase concentrations', 'efficacy endpoints (progression-free survival, overall survival, and best overall response', 'ctDNA', 'overall survival outcome (hazard ratio [HR', 'overall survival', 'baseline lactate dehydrogenase concentrations']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0580586', 'cui_str': 'Extracranial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}]","[{'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0151754', 'cui_str': '[D]Lactic acid dehydrogenase raised'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}]",423.0,0.610155,"In COMBI-d, undetectable ctDNA at week 4 was significantly associated with extended progression-free and overall survival, particularly in patients with elevated lactate dehydrogenase concentrations (HR 1·99 [95% CI 1·08-3·64], p=0·027 for progression-free survival; 2·38 [1·24-4·54], p=0·0089 for overall survival).
","[{'ForeName': 'Mahrukh M', 'Initials': 'MM', 'LastName': 'Syeda', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Wiggins', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Broderick C', 'Initials': 'BC', 'LastName': 'Corless', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Dana-Farber Cancer Institute/Harvard Medical School and Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Nathan', 'Affiliation': 'East and North NHS Trust, Northwood, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Institute Gustave Roussy and Paris-Sud University, Villejuif, France.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Davies', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jean Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Dermatology and Skin Cancer Department, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Squires', 'Affiliation': 'Novartis Institute for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Marker', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Garrett', 'Affiliation': 'Novartis Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Brase', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Polsky', 'Affiliation': 'NYU Langone Health, New York, NY, USA. Electronic address: david.polsky@nyulangone.org.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30726-9']
391,33608413,Improving Parent-Child Interactions in Pediatric Health Care: A Two-Site Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


Heterogeneity in risk among low-income families suggests the need for tiered interventions to prevent disparities in school readiness. Smart Beginnings (SB) integrates two interventions: Video Interaction Project (VIP) (birth to 3 years), delivered universally to low-income families in pediatric primary care, and Family Check-Up (6 months to 3 years), targeted home visiting for families with additional family risks. Our objective was to assess initial SB impacts on parent-child activities and interactions at 6 months, reflecting early VIP exposure.
METHODS


Two-site randomized controlled trial in New York City (84% Latinx) and Pittsburgh (81% Black), with postpartum enrollment and random assignment to treatment (SB) or control. At 6 months, we assessed parent-child interactions through surveys (StimQ, Parenting Your Baby) and observation (video-recorded play, coded by using Parent-Child Interaction Rating Scales - Infant Adaptation).
RESULTS


A total of 403 families were enrolled at child's birth (201 treatment) with 362 (89.8%) assessed at 6 months. Treatment families had increased StimQ, including total score (Cohen's  d  = 0.28;  P  < .001) and domains reflecting reading ( d  = 0.23;  P  = .02) and teaching ( d  = 0.25;  P  = .01), and Parent-Child Interaction Rating Scales - Infant Adaptation, including a cognitive stimulation factor ( d  = 0.40;  P  < .001) and domains reflecting support for cognitive development ( d  = 0.36;  P  < .001), and language quantity (0.40;  P  < .001) and quality ( d  = 0.37;  P  < .001). Thus, significant effects emerged across a broad sample by using varied methodologies.
CONCLUSIONS


Findings replicate and extend previous VIP findings across samples and assessment methodologies. Examining subsequent assessments will determine impacts and feasibility of the full SB model, including potential additive impacts of Family Check-Up for families at elevated risk.",2021,"Treatment families had increased StimQ, including total score (Cohen's  d  = 0.28;  P  < .001) and domains reflecting reading ( d  = 0.23;  P  = .02) and teaching ( d  = 0.25;  P  = .01), and Parent-Child Interaction Rating Scales - Infant Adaptation, including a cognitive stimulation factor ( d  = 0.40;  P  < .001) and domains reflecting support for cognitive development ( d  = 0.36;  P  < .001), and language quantity (0.40;  P  < .001) and quality ( d  = 0.37;  P  < .001).","['New York City (84% Latinx) and Pittsburgh (81% Black), with postpartum enrollment and random assignment to treatment (SB) or control', 'Pediatric Health Care', ""A total of 403 families were enrolled at child's birth (201 treatment) with 362 (89.8%) assessed at 6 months""]",[],"['parent-child interactions through surveys (StimQ, Parenting Your Baby) and observation (video-recorded play, coded by using Parent-Child Interaction Rating Scales - Infant Adaptation', 'language quantity', 'StimQ, including total score', 'quality', 'cognitive development', 'Parent-Child Interaction Rating Scales - Infant Adaptation, including a cognitive stimulation factor']","[{'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0581135', 'cui_str': 'Birth of child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}]",403.0,0.194415,"Treatment families had increased StimQ, including total score (Cohen's  d  = 0.28;  P  < .001) and domains reflecting reading ( d  = 0.23;  P  = .02) and teaching ( d  = 0.25;  P  = .01), and Parent-Child Interaction Rating Scales - Infant Adaptation, including a cognitive stimulation factor ( d  = 0.40;  P  < .001) and domains reflecting support for cognitive development ( d  = 0.36;  P  < .001), and language quantity (0.40;  P  < .001) and quality ( d  = 0.37;  P  < .001).","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Roby', 'Affiliation': 'Department of Pediatrics, NYU Grossman School of Medicine and.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Miller', 'Affiliation': 'Department of Pediatrics, NYU Grossman School of Medicine and.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Morris', 'Affiliation': 'Steinhardt School of Culture, Education, and Human Development, New York University, New York, New York.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gill', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Bogen', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Johana', 'Initials': 'J', 'LastName': 'Rosas', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Caitlin F', 'Initials': 'CF', 'LastName': 'Canfield', 'Affiliation': 'Department of Pediatrics, NYU Grossman School of Medicine and.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Hails', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Wippick', 'Affiliation': 'Steinhardt School of Culture, Education, and Human Development, New York University, New York, New York.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Honoroff', 'Affiliation': 'Steinhardt School of Culture, Education, and Human Development, New York University, New York, New York.'}, {'ForeName': 'Carolyn B', 'Initials': 'CB', 'LastName': 'Cates', 'Affiliation': 'School of Natural and Social Sciences, Purchase College, State University of New York, Purchase, New York; and.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Weisleder', 'Affiliation': 'Department of Communication Sciences and Disorders, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Chadwick', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Caroline D', 'Initials': 'CD', 'LastName': 'Raak', 'Affiliation': 'Department of Pediatrics, NYU Grossman School of Medicine and.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'Department of Pediatrics, NYU Grossman School of Medicine and alan.mendelsohn@nyulangone.org.'}]",Pediatrics,['10.1542/peds.2020-1799']
392,33579652,Effects of a Lifestyle Change Intervention on Semen Quality in Healthy Young Men Living in Highly Polluted Areas in Italy: The FASt Randomized Controlled Trial.,"BACKGROUND


Human semen quality is affected by lifestyle and environmental factors.
OBJECTIVE


To evaluate the short-term effects of a diet and physical activity intervention on semen quality of healthy young men living in highly polluted areas of Italy.
DESIGN, SETTING, AND PARTICIPANTS


A randomized controlled trial was conducted. Healthy young men were assigned to an intervention or a control group.
INTERVENTION


A 4-mo Mediterranean diet and moderate physical activity program.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary outcomes were sperm concentration, motility and morphology, concentration of round cells, and semen total antioxidant capacity. Secondary outcomes were adherence to Mediterranean diet and physical activity. All outcomes were measured twice, at the enrollment (t0) and at the end of the intervention (t4).
RESULTS AND LIMITATIONS


A total of 263 individuals attended all visits, and underwent examinations and laboratory analyses: 137 in the intervention group and 126 in the control group. The adherence to Mediterranean diet and physical activity level increased more in the intervention group than in the control group from t0 to t4. Sperm concentration, total and progressive motility, and proportion of normal morphology cells increased in the intervention group but decreased in the control group, with statistically significant differences between the two groups at t4. The total antioxidant capacity increased in the intervention group but decreased in the control group, from t0 to t4.
CONCLUSIONS


Study results showed that an intervention based on Mediterranean diet and regular physical activity can determine an improvement of semen quality in healthy young men.
PATIENT SUMMARY


Our study aimed to evaluate the effect of a lifestyle intervention on semen quality of healthy young men. We assigned the 263 enrolled individuals to an intervention or a control group. The intervention group followed a 4-mo Mediterranean diet and moderate physical activity program, at the end of which the participants showed an improvement of semen quality parameters.",2022,The adherence to Mediterranean diet and physical activity level increased more in the intervention group than in the control group from t0 to t4.,"['Healthy Young Men Living in Highly Polluted Areas in Italy', 'healthy young men living in highly polluted areas of Italy', 'healthy young men', '263 enrolled individuals to an intervention or a control group', 'Healthy young men', '263 individuals attended all visits, and underwent examinations and laboratory analyses: 137 in the intervention group and 126 in the control group']","['control group', 'diet and physical activity intervention', 'Lifestyle Change Intervention', 'lifestyle intervention', '4-mo Mediterranean diet and moderate physical activity program']","['sperm concentration, motility and morphology, concentration of round cells, and semen total antioxidant capacity', 'total antioxidant capacity', 'Semen Quality', 'semen quality', 'adherence to Mediterranean diet and physical activity', 'adherence to Mediterranean diet and physical activity level', 'semen quality parameters', 'Sperm concentration, total and progressive motility, and proportion of normal morphology cells']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]",263.0,0.051122,The adherence to Mediterranean diet and physical activity level increased more in the intervention group than in the control group from t0 to t4.,"[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Montano', 'Affiliation': 'Andrology Unit and Service of Lifestyle Medicine in UroAndrology, Local Health Authority (ASL) Salerno, Coordination Unit of the network for Environmental and Reproductive Health (EcoFoodFertility Project), Italy ""Oliveto Citra Hospital"", Salerno, Italy; PhD Program in Evolutionary Biology and Ecology, University of Rome Tor Vergata, Rome, Italy. Electronic address: l.montano@aslsalerno.it.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Ceretti', 'Affiliation': 'Unit of Hygiene, Epidemiology and Public Health, and Unit of Urology, Department of Medical and Surgical Specialties Radiological, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Donato', 'Affiliation': 'Unit of Hygiene, Epidemiology and Public Health, and Unit of Urology, Department of Medical and Surgical Specialties Radiological, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bergamo', 'Affiliation': 'Institute of Food Sciences, National Research Council (CNR-ISA), Avellino, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Zani', 'Affiliation': 'Unit of Hygiene, Epidemiology and Public Health, and Unit of Urology, Department of Medical and Surgical Specialties Radiological, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Gaia Claudia Viviana', 'Initials': 'GCV', 'LastName': 'Viola', 'Affiliation': 'Unit of Hygiene, Epidemiology and Public Health, and Unit of Urology, Department of Medical and Surgical Specialties Radiological, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Notari', 'Affiliation': 'Andrology Unit and Service of Lifestyle Medicine in UroAndrology, Local Health Authority (ASL) Salerno, Coordination Unit of the network for Environmental and Reproductive Health (EcoFoodFertility Project), Italy ""Oliveto Citra Hospital"", Salerno, Italy; PhD Program in Evolutionary Biology and Ecology, University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Sebastiana', 'Initials': 'S', 'LastName': 'Pappalardo', 'Affiliation': 'Andrology Unit and Service of Lifestyle Medicine in UroAndrology, Local Health Authority (ASL) Salerno, Coordination Unit of the network for Environmental and Reproductive Health (EcoFoodFertility Project), Italy ""Oliveto Citra Hospital"", Salerno, Italy; PhD Program in Evolutionary Biology and Ecology, University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Zani', 'Affiliation': 'Unit of Hygiene, Epidemiology and Public Health, and Unit of Urology, Department of Medical and Surgical Specialties Radiological, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Ubaldi', 'Affiliation': 'Andrology Unit and Service of Lifestyle Medicine in UroAndrology, Local Health Authority (ASL) Salerno, Coordination Unit of the network for Environmental and Reproductive Health (EcoFoodFertility Project), Italy ""Oliveto Citra Hospital"", Salerno, Italy; PhD Program in Evolutionary Biology and Ecology, University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Bollati', 'Affiliation': 'Epidemiology, Epigenetics and Toxicology (EPIGET) Lab, Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Consales', 'Affiliation': 'Laboratory of Health and Environment, Division of Health Protection Technologies, ENEA Casaccia Research Center, Rome, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Leter', 'Affiliation': 'Laboratory of Health and Environment, Division of Health Protection Technologies, ENEA Casaccia Research Center, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Trifuoggi', 'Affiliation': 'Department of Chemical Sciences, University of Naples Federico II, Complesso Universitario Monte S. Angelo, Naples, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Amoresano', 'Affiliation': 'Department of Chemical Sciences, University of Naples Federico II, Complesso Universitario Monte S. Angelo, Naples, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Lorenzetti', 'Affiliation': 'Department of Food Safety, Nutrition and Veterinary Public Health, Italian National Institute of Health (ISS), Rome, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology focus,['10.1016/j.euf.2021.01.017']
393,33584054,Clinical Post-operative Bleeding During Minor Oral Surgical Procedure and In Vitro Platelet Aggregation in Patients on Aspirin Therapy: Are they Coherent?,"Aim


The risk of excessive bleeding prompts physicians to discontinue aspirin in patients on low-dose, long-term therapy which in turn puts them at the risk from adverse cardiovascular and thrombotic events. Effect of low-dose aspirin therapy on platelet function was assessed using platelet aggregation method. The aim was to correlate the laboratory platelet function with cutaneous and clinical oral bleeding time (BT).
Materials and Methods


One hundred one patients were enrolled in this prospective trial and were allocated into two groups. Interventional or test group consisted of patients who were on aspirin therapy (75 mg/100 mg) for primary or secondary prevention of angina, myocardial infarction and stroke. Minor oral surgical procedure was performed in this group without discontinuing aspirin therapy. Control group consisted of healthy patients (under no medication) undergoing minor oral surgical procedure. Cutaneous and clinical oral BT were recorded in both the groups. Venous blood sample was drawn, and percentage platelet aggregation function was analysed using adenosine diphosphate (ADP) and arachidonic acid (AA) reagents. The percentage of platelet aggregation was then correlated with cutaneous and clinical oral BT.
Results


A significant decrease in percentage platelet aggregation using ADP (aspirin-74.7 21.39; control-89.2 13.70) and AA (aspirin-47.6 23.11; control-82.3 20.17) was observed. However, there were no significant difference in mean cutaneous BT (aspirin-1.5 0.65 min; control-1.6 0.71 min) and clinical oral BT (aspirin-5.0 2.48 min; control-4.8 2.60 min) in aspirin and control groups.
Conclusion


Majority of the minor oral surgical procedures can be carried out safely without discontinuing aspirin in patients on low-dose long-term therapy. This is possible because despite significant platelet aggregation evident in laboratory evaluation there is lack of its clinical corroboration owing to aspirin resistance.
Clinical Trial Registration


CTRI/2018/02/012055.",2021,A significant decrease in percentage platelet aggregation using ADP (aspirin-74.7 21.39; control-89.2 13.70) and AA (aspirin-47.6 23.11; control-82.3 20.17) was observed.,"['Patients on', 'One hundred one patients']","['Aspirin Therapy', 'healthy patients (under no medication) undergoing minor oral surgical procedure', 'low-dose aspirin therapy', 'aspirin', 'aspirin therapy', 'discontinue aspirin']","['laboratory platelet function with cutaneous and clinical oral bleeding time (BT', 'platelet function', 'percentage of platelet aggregation', 'mean cutaneous BT', 'percentage platelet aggregation', 'Cutaneous and clinical oral BT', 'adenosine diphosphate (ADP) and arachidonic acid (AA) reagents']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C4303556', 'cui_str': 'Aspirin therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0524861', 'cui_str': 'Oral surgery'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0029163', 'cui_str': 'Bleeding from mouth'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005729', 'cui_str': 'Bleeding time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0034760', 'cui_str': 'Reagents'}]",101.0,0.0221892,A significant decrease in percentage platelet aggregation using ADP (aspirin-74.7 21.39; control-89.2 13.70) and AA (aspirin-47.6 23.11; control-82.3 20.17) was observed.,"[{'ForeName': 'Surjit', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Jodhpur, India.'}, {'ForeName': 'Saptarshi', 'Initials': 'S', 'LastName': 'Mandal', 'Affiliation': 'Department of Transfusion Medicine, All India Institute of Medical Sciences, Jodhpur, Jodhpur, India.'}, {'ForeName': 'Ankita', 'Initials': 'A', 'LastName': 'Chugh', 'Affiliation': 'Department of Dentistry, All India Institute of Medical Sciences, Jodhpur, Jodhpur, India.'}, {'ForeName': 'Surender', 'Initials': 'S', 'LastName': 'Deora', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences, Jodhpur, Jodhpur, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Jain', 'Affiliation': 'Department of Dentistry, All India Institute of Medical Sciences, Jodhpur, Jodhpur, India.'}, {'ForeName': 'Md Atik', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Department of Transfusion Medicine, All India Institute of Medical Sciences, Jodhpur, Jodhpur, India.'}, {'ForeName': 'Vinay Kumar', 'Initials': 'VK', 'LastName': 'Chugh', 'Affiliation': 'Department of Dentistry, All India Institute of Medical Sciences, Jodhpur, Jodhpur, India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01438-4']
394,33584049,"Body Weight Loss After Orthognathic Surgery: Comparison Between Postoperative Intermaxillary Fixation with Metal Wire and Elastic Traction, Factors Related to Body Weight Loss.","Introduction


The aim of this study was to compare body weight loss between postoperative intermaxillary fixation with metal wire and elastic traction and to investigate factors related to body weight loss after orthognathic surgery.
Materials and methods


Subjects were 59 patients with dentofacial deformity, comprising 31 patients treated with intermaxillary fixation (IMF) and 28 patients treated with elastic traction without IMF (ELT) just after surgery. Body weight loss was measured at 1 week (T1) and 2 weeks (T2) after surgery. Body weight loss was compared between IMF and ELT, and factors related to body weight loss were statistically analyzed.
Results


Body weight loss ratio was significantly increased in IMF (2.6%) rather than in ELT (1.4%) at T1, but only tended to be increased in both groups at T2, showing no statistical difference. Body weight loss ratio was significantly increased at T2 compared to T1 in both groups. Body weight loss was significantly greater at T2 than at T1.
Conclusion


Both IMF and ELT cause body weight loss after orthognathic surgery, but IMF causes body weight loss earlier than ELT and increased early body weight loss increases continuous body weight loss after orthognathic surgery.",2021,"Results


Body weight loss ratio was significantly increased in IMF (2.6%) rather than in ELT (1.4%) at T1, but only tended to be increased in both groups at T2, showing no statistical difference.","['59 patients with dentofacial deformity, comprising 31 patients treated with']","['postoperative intermaxillary fixation with metal wire and elastic traction', 'Postoperative Intermaxillary Fixation with Metal Wire and Elastic Traction', 'elastic traction without IMF (ELT', 'intermaxillary fixation (IMF']","['body weight loss', 'Body weight loss', 'Body weight loss ratio', 'Body Weight Loss', 'IMF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3494419', 'cui_str': 'Dentofacial Deformities'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0040597', 'cui_str': 'Traction'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",59.0,0.014282,"Results


Body weight loss ratio was significantly increased in IMF (2.6%) rather than in ELT (1.4%) at T1, but only tended to be increased in both groups at T2, showing no statistical difference.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ooi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takaramachi, Kanazawa, Ishikawa 920-8641 Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Inoue', 'Affiliation': 'Gerodontology, Department of Oral Health Science, Graduate School of Dental Medicine, Hokkaido University, Kita 13 Nishi 7 Kita-ku, Sapporo, Hokkaido 060-8586 Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Matsushita', 'Affiliation': 'Oral and Maxillofacial Surgery, Department of Oral Patho-biological Science, Graduate School of Dental Medicine, Hokkaido University, Kita 13 Nishi 7 Kita-ku, Sapporo, Hokkaido 060-8586 Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Oral and Maxillofacial Surgery, Department of Oral Patho-biological Science, Graduate School of Dental Medicine, Hokkaido University, Kita 13 Nishi 7 Kita-ku, Sapporo, Hokkaido 060-8586 Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mikoya', 'Affiliation': 'Oral and Maxillofacial Surgery, Department of Oral Patho-biological Science, Graduate School of Dental Medicine, Hokkaido University, Kita 13 Nishi 7 Kita-ku, Sapporo, Hokkaido 060-8586 Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kawashiri', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takaramachi, Kanazawa, Ishikawa 920-8641 Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tei', 'Affiliation': 'Oral and Maxillofacial Surgery, Department of Oral Patho-biological Science, Graduate School of Dental Medicine, Hokkaido University, Kita 13 Nishi 7 Kita-ku, Sapporo, Hokkaido 060-8586 Japan.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-019-01318-6']
395,33605930,A randomised controlled study on the effects of hernial sac stump fenestration on ultrasound seroma prevention in laparoscopic Type III inguinal hernia repair.,"Background


The incidence of ultrasound seromas has significantly increased after large hernial sac surgery. Several methods are available for preventing ultrasound seromas, but the clinical results are poor. It has also been demonstrated that hernial sac stump fenestration during laparoscopic incisional hernia repair surgery can significantly decrease the incidence of ultrasound seromas.
Materials and Methods


Ninety patients aged 18-75 years who were treated in our hospital for primary Type III indirect inguinal hernia from March 2017 to March 2018 were randomised to a preventive fenestration group and a control group. All patients underwent transabdominal preperitoneal repair. The number of ultrasound seromas in the inguinal regions and ultrasound seroma volume on day 6 and months 1 and 3 after surgery in the two groups were compared. The secondary outcomes included length of surgery, urinary retention, acute pain, chronic pain, length of hospitalisation, recurrence rate and other complications.
Results


There were no significant differences in demographic characteristics. Ultrasound seroma incidence and ultrasound seroma volume on day 6 and months 1 and 3 after surgery were significantly lower in the preventive fenestration group than that in the control group. There were no significant differences in the length of hospitalisation or incidence of acute pain or urinary retention between the two groups.
Conclusions


Hernial sac stump fenestration after hernial sac transection in inguinal hernia repair surgery is a simple method that can effectively reduce post-operative ultrasound seromas.",2022,"There were no significant differences in the length of hospitalisation or incidence of acute pain or urinary retention between the two groups.
","['Ninety patients aged 18-75 years who were treated in our hospital for primary Type III indirect inguinal hernia from March 2017 to March 2018', 'laparoscopic Type III inguinal hernia repair']","['transabdominal preperitoneal repair', 'preventive fenestration group and a control group', 'hernial sac stump fenestration']","['Ultrasound seroma incidence and ultrasound seroma volume', 'number of ultrasound seromas in the inguinal regions and ultrasound seroma volume', 'demographic characteristics', 'length of surgery, urinary retention, acute pain, chronic pain, length of hospitalisation, recurrence rate and other complications', 'incidence of ultrasound seromas', 'length of hospitalisation or incidence of acute pain or urinary retention']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0019296', 'cui_str': 'Indirect inguinal hernia'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}]","[{'cui': 'C0205496', 'cui_str': 'Abdominal approach'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0015825', 'cui_str': 'Inner ear fenestration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002690', 'cui_str': 'Amputation stump'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",90.0,0.074318,"There were no significant differences in the length of hospitalisation or incidence of acute pain or urinary retention between the two groups.
","[{'ForeName': 'Wei-Ming', 'Initials': 'WM', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan Province, China.'}, {'ForeName': 'Yan-Bo', 'Initials': 'YB', 'LastName': 'Sun', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan Province, China.'}, {'ForeName': 'Yi-Jun', 'Initials': 'YJ', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan Province, China.'}, {'ForeName': 'Peng-Yuan', 'Initials': 'PY', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan Province, China.'}, {'ForeName': 'Qing-Wen', 'Initials': 'QW', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan Province, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Ding', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan Province, China.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_185_20']
396,33613928,Effects of Sevoflurane versus Propofol on Endogenous Nitric Oxide Metabolism during Laparoscopic Surgery.,"For laparoscopic surgery, it is very difficult to assess the effect of different medicines used in the surgical procedure on the surgical results. In the past, doctors could use sevoflurane to numb and calm patients. For decades, this type of treatment has been fairly reliable and effective, but for laparoscopic surgery, the use of sevoflurane can lead to a wide range of blood glucose changes, so in recent years, sevoflurane compared to propofol in laparoscopic surgery on endogenous and nitrogen oxide metabolism has been studied more and more. In this paper, a variety of research methods were used to study the phenomenon of shock and excessive anesthesia encountered by patients in the treatment process. Through observation and drug experiment of patients in different treatment courses and treatment stages, patients were asked to use sevoflurane and propofol to conduct double-blind experiments on their own drug effects. At the same time, through the long-term observation of patients with different diseases and patients who need laparoscopic surgery, the nitrogen oxide metabolism in patients with sevoflurane compared with propofol endogenous was studied and analyzed. Through three groups of different conditions, the experimental group, the blind test group, and the control group were studied. To conclude, in laparoscopic surgery, the use of sevoflurane compared with propofol can have a good impact on the endogenous drug and nitrogen oxide metabolism. It can achieve a good effect on the anesthesia effect of surgery, the maintenance of patient's physical signs and heart rate, which is very beneficial to the operation.  Conclusion . Sevoflurane compared with propofol has a good effect on endogenous nitrogen oxide metabolism in laparoscopic surgery.",2021,Sevoflurane compared with propofol has a good effect on endogenous nitrogen oxide metabolism in laparoscopic surgery.,"['Laparoscopic Surgery', 'laparoscopic surgery']","['Sevoflurane', 'propofol', 'sevoflurane', 'Propofol', 'sevoflurane and propofol']","['endogenous drug and nitrogen oxide metabolism', 'Endogenous Nitric Oxide Metabolism', 'nitrogen oxide metabolism', 'endogenous nitrogen oxide metabolism']","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0573303,Sevoflurane compared with propofol has a good effect on endogenous nitrogen oxide metabolism in laparoscopic surgery.,"[{'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Xinle Hospital, Shijiazhuang 050700, Hebei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Xinle Hospital, Shijiazhuang 050700, Hebei, China.'}, {'ForeName': 'Ruiling', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': 'Room of Operating, Xinle Hospital, Shijiazhuang 050700, Hebei, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Department of Urology, Xinle Hospital, Shijiazhuang 050700, Hebei, China.'}, {'ForeName': 'Yongzhang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Hebei Hospital of Traditional Chinese Medicine, Shijiazhuang 050700, Hebei, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Xinle Hospital, Shijiazhuang 050700, Hebei, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei, China.'}]",Journal of healthcare engineering,['10.1155/2021/6691943']
397,33583199,Effect of Intensive Versus Standard Blood Pressure Control on Stroke Subtypes.,[Figure: see text].,2021,"In the SPRINT (Systolic Blood Pressure Intervention Trial), the number of strokes did not differ significantly by treatment group.","['stroke subtypes across treatment arms included hemorrhagic (intensive treatment, n=6, standard treatment, n=7) and ischemic stroke subtypes (large artery atherosclerosis: intensive treatment n=11, standard treatment, n=13; cardiac embolism', 'SPRINT participants (N=9361', 'of 121.4 mm Hg in the intensive arm (N=4678) and', 'Stroke Subtypes']","['intensive treatment n=11, standard treatment n=15; small artery occlusion: intensive treatment n=8, standard treatment n=8; other ischemic stroke: intensive treatment n=3, standard treatment n=1', 'Intensive Versus Standard Blood Pressure Control']","['stroke subtypes', 'mean systolic blood pressures', 'number of strokes', 'Fewer strokes']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0226003', 'cui_str': 'Structure of large artery'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0442840', 'cui_str': 'Cardiac embolism'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0226001', 'cui_str': 'Structure of small artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205388', 'cui_str': 'Few'}]",9361.0,0.0817278,"In the SPRINT (Systolic Blood Pressure Intervention Trial), the number of strokes did not differ significantly by treatment group.","[{'ForeName': 'Clinton B', 'Initials': 'CB', 'LastName': 'Wright', 'Affiliation': 'From the Division of Clinical Research, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (C.B.W.).'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Auchus', 'Affiliation': 'Department of Neurology, University of Mississippi Medical Center, Jackson (A.P.A.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Lerner', 'Affiliation': 'Department of Neurology, Case Western Reserve University, Cleveland, OH (A.L.).'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC (W.T.A., J.J.W.).'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Ay', 'Affiliation': 'Departments of Neurology and Radiology, Massachusetts General Hospital, Harvard Medical School, Boston (H.A.).'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Bates', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX (J.T.B.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, Tulane School of Medicine, New Orleans, LA (J.C.).'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Meschia', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M.).'}, {'ForeName': 'Suchita', 'Initials': 'S', 'LastName': 'Pancholi', 'Affiliation': 'Department of Medicine, University of South Carolina School of Medicine, Columbia (S.P.).'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Papademetriou', 'Affiliation': 'Department of Medicine, Georgetown University School of Medicine, Washington, DC (V.P.).'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Medicine, UCLA School of Medicine, Los Angeles, CA (A.R.).'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sweeney', 'Affiliation': 'Department of Medicine, Emory University School of Medicine, Atlanta, GA (M.S.).'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Willard', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC (W.T.A., J.J.W.).'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Yee', 'Affiliation': 'Division of Nephrology and Hypertension, Henry Ford Hospital, Detroit, MI (J.Y.).'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham (S.O.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.16027']
398,33612170,Effectiveness of Minimal Contact Interventions: An RCT.,"INTRODUCTION


Around 23% of adults worldwide are insufficiently active. Wearable devices paired with virtual coaching software could increase physical activity. The effectiveness of 3 minimal contact interventions (paper-based physical activity diaries, activity trackers, and activity trackers coupled with virtual coaching) in increasing physical activity energy expenditure and cardiorespiratory fitness were compared over 12 weeks among inactive adults.
METHODS


This was an open label, parallel-group RCT. Inactive adults (aged ≥18 years, N=488) were randomized to no intervention (Control; n=121), paper-based diary (Diary; n=124), activity tracker (Activity Band; n=122), or activity tracker plus virtual coaching (Activity Band PLUS; n=121) groups. Coprimary outcomes included 12-week changes in physical activity energy expenditure and fitness (May 2012-January 2014). Analyses were conducted in 2019-2020.
RESULTS


There were no differences between groups overall (physical activity energy expenditure: p=0.114, fitness: p=0.417). However, there was a greater increase in physical activity energy expenditure (4.21 kJ/kg/day, 95% CI=0.42, 8.00) in the Activity Band PLUS group than in the Diary group. There were also greater decreases in BMI and body fat percentage in the Activity Band PLUS group than in the Control group (BMI= -0.24 kg/m 2 , 95% CI= -0.45, -0.03; body fat= -0.48%, 95% CI= -0.88, -0.08) and in theActivity Band PLUS group than in the Diary group (BMI= -0.30 kg/m 2 , 95% CI= -0.50, -0.09; body fat= -0.57%, 95% CI= -0.97, -0.17).
CONCLUSIONS


Coupling activity trackers with virtual coaching may facilitate increases in physical activity energy expenditure compared with a traditional paper‒based physical activity diary intervention and improve some secondary outcomes compared with a traditional paper‒based physical activity diary intervention or no intervention.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov ISRCTN31844443.",2021,"There were no differences between groups overall (physical activity energy expenditure: p=0.114, fitness: p=0.417).","['Inactive adults (aged ≥18 years, N=488']","['activity tracker (Activity Band; n=122), or activity tracker plus virtual coaching (Activity Band PLUS', 'Minimal Contact Interventions', '3 minimal contact interventions (paper-based physical activity diaries, activity trackers, and activity trackers coupled with virtual coaching']","['physical activity', 'BMI and body fat percentage', 'physical activity energy expenditure and cardiorespiratory fitness', 'physical activity energy expenditure and fitness (May 2012-January 2014', 'physical activity energy expenditure']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",,0.0676574,"There were no differences between groups overall (physical activity energy expenditure: p=0.114, fitness: p=0.417).","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hajna', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Andrew J M', 'Initials': 'AJM', 'LastName': 'Cooper', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Williams', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Esther M F', 'Initials': 'EMF', 'LastName': 'van Sluijs', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Soren', 'Initials': 'S', 'LastName': 'Brage', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom; Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom. Electronic address: profgp@medschl.cam.ac.uk.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.10.010']
399,33620405,"Effect of Vitamin C, Thiamine, and Hydrocortisone on Ventilator- and Vasopressor-Free Days in Patients With Sepsis: The VICTAS Randomized Clinical Trial.","Importance


Sepsis is a common syndrome with substantial morbidity and mortality. A combination of vitamin C, thiamine, and corticosteroids has been proposed as a potential treatment for patients with sepsis.
Objective


To determine whether a combination of vitamin C, thiamine, and hydrocortisone every 6 hours increases ventilator- and vasopressor-free days compared with placebo in patients with sepsis.
Design, Setting, and Participants


Multicenter, randomized, double-blind, adaptive-sample-size, placebo-controlled trial conducted in adult patients with sepsis-induced respiratory and/or cardiovascular dysfunction. Participants were enrolled in the emergency departments or intensive care units at 43 hospitals in the United States between August 2018 and July 2019. After enrollment of 501 participants, funding was withheld, leading to an administrative termination of the trial. All study-related follow-up was completed by January 2020.
Interventions


Participants were randomized to receive intravenous vitamin C (1.5 g), thiamine (100 mg), and hydrocortisone (50 mg) every 6 hours (n = 252) or matching placebo (n = 249) for 96 hours or until discharge from the intensive care unit or death. Participants could be treated with open-label corticosteroids by the clinical team, with study hydrocortisone or matching placebo withheld if the total daily dose was greater or equal to the equivalent of 200 mg of hydrocortisone.
Main Outcomes and Measures


The primary outcome was the number of consecutive ventilator- and vasopressor-free days in the first 30 days following the day of randomization. The key secondary outcome was 30-day mortality.
Results


Among 501 participants randomized (median age, 62 [interquartile range {IQR}, 50-70] years; 46% female; 30% Black; median Acute Physiology and Chronic Health Evaluation II score, 27 [IQR, 20.8-33.0]; median Sequential Organ Failure Assessment score, 9 [IQR, 7-12]), all completed the trial. Open-label corticosteroids were prescribed to 33% and 32% of the intervention and control groups, respectively. Ventilator- and vasopressor-free days were a median of 25 days (IQR, 0-29 days) in the intervention group and 26 days (IQR, 0-28 days) in the placebo group, with a median difference of -1 day (95% CI, -4 to 2 days; P = .85). Thirty-day mortality was 22% in the intervention group and 24% in the placebo group.
Conclusions and Relevance


Among critically ill patients with sepsis, treatment with vitamin C, thiamine, and hydrocortisone, compared with placebo, did not significantly increase ventilator- and vasopressor-free days within 30 days. However, the trial was terminated early for administrative reasons and may have been underpowered to detect a clinically important difference.
Trial Registration


ClinicalTrials.gov Identifier: NCT03509350.",2021,"Thirty-day mortality was 22% in the intervention group and 24% in the placebo group.
","['adult patients with sepsis-induced respiratory and/or cardiovascular dysfunction', '501 participants randomized (median age, 62 [interquartile range {IQR}, 50-70] years; 46% female; 30% Black; median Acute Physiology and Chronic Health Evaluation II score, 27 [IQR, 20.8-33.0]; median Sequential Organ Failure Assessment score, 9 [IQR, 7-12]), all completed the trial', 'critically ill patients with sepsis, treatment with', 'patients with sepsis', 'Patients With Sepsis', 'Participants were enrolled in the emergency departments or intensive care units at 43 hospitals in the United States between August 2018 and July 2019', '501 participants, funding was withheld, leading to an administrative termination of the trial']","['Open-label corticosteroids', 'placebo', 'intravenous vitamin C', 'hydrocortisone or matching placebo', 'hydrocortisone', 'Vitamin C, Thiamine, and Hydrocortisone', 'vitamin C, thiamine, and hydrocortisone', 'vitamin C, thiamine, and corticosteroids', 'matching placebo', 'thiamine']","['number of consecutive ventilator- and vasopressor-free days', 'Thirty-day mortality', '30-day mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4758051', 'cui_str': 'APACHE II (Acute Physiology and Chronic Health Evaluation II) score'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0376244', 'cui_str': 'funding'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",501.0,0.776161,"Thirty-day mortality was 22% in the intervention group and 24% in the placebo group.
","[{'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Sevransky', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care, and Sleep, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Rothman', 'Affiliation': 'Department of Emergency Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Hager', 'Affiliation': 'Division of Pulmonary Critical Care, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Gordon R', 'Initials': 'GR', 'LastName': 'Bernard', 'Affiliation': 'Division of Pulmonary Critical Care, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Brown', 'Affiliation': 'Division of Pulmonary Critical Care, Intermountain Medical Center and University of Utah, Salt Lake City.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Buchman', 'Affiliation': 'Emory Critical Care Center, Emory Healthcare, Atlanta, Georgia.'}, {'ForeName': 'Laurence W', 'Initials': 'LW', 'LastName': 'Busse', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care, and Sleep, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'Coopersmith', 'Affiliation': 'Emory Critical Care Center, Emory Healthcare, Atlanta, Georgia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'DeWilde', 'Affiliation': 'Division of Pulmonary Critical Care, Virginia Commonwealth University, Richmond.'}, {'ForeName': 'E Wesley', 'Initials': 'EW', 'LastName': 'Ely', 'Affiliation': 'Division of Pulmonary Critical Care, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Eyzaguirre', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Alpha A', 'Initials': 'AA', 'LastName': 'Fowler', 'Affiliation': 'Division of Pulmonary Critical Care, Virginia Commonwealth University, Richmond.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Gaieski', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Gong', 'Affiliation': 'Department of Critical Care, Montefiore Medical Center, Bronx, New York.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'Department of Emergency Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jeremiah S', 'Initials': 'JS', 'LastName': 'Hinson', 'Affiliation': 'Department of Emergency Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Hooper', 'Affiliation': 'Division of Pulmonary Critical Care, Sentara Healthcare, Norfolk, Virginia.'}, {'ForeName': 'Gabor D', 'Initials': 'GD', 'LastName': 'Kelen', 'Affiliation': 'Department of Emergency Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Division of Pulmonary Critical Care, Oregon Health & Science University, Portland.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Levine', 'Affiliation': 'Molecular and Clinical Nutrition Section, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Lewis', 'Affiliation': 'Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Marlin', 'Affiliation': 'Vanderbilt Coordinating Center, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McGlothlin', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Brooks L', 'Initials': 'BL', 'LastName': 'Moore', 'Affiliation': 'Department of Emergency Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Nugent', 'Affiliation': 'Department of Emergency Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Nwosu', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Carmen C', 'Initials': 'CC', 'LastName': 'Polito', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care, and Sleep, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Pulmonary Critical Care, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Erin P', 'Initials': 'EP', 'LastName': 'Ricketts', 'Affiliation': 'Department of Emergency Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Caroline C', 'Initials': 'CC', 'LastName': 'Rudolph', 'Affiliation': 'Department of Emergency Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Sanfilippo', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kert', 'Initials': 'K', 'LastName': 'Viele', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Greg S', 'Initials': 'GS', 'LastName': 'Martin', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care, and Sleep, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wright', 'Affiliation': 'Department of Emergency Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.24505']
400,33620714,Increasing Prenatal Care Compliance in At-Risk Black Women: Findings from a RCT of Patient Navigation and Behavioral Incentives.,"BACKGROUND


In the USA, infant mortality remains a major public health concern, particularly for Black women and their infants who continue to experience disproportionately high mortality rates. Prenatal care is a key determinant of infant health, with inadequate prenatal care increasing risk for prematurity, stillbirth, neonatal loss, and infant death. The aim of the present study was to determine if concurrent delivery of patient navigation and behavioral incentives to at-risk Black pregnant women could improve prenatal care attendance and associated maternal and infant outcomes.
METHODS


Participants were 150 Black pregnant women recruited at first prenatal visit and screening at risk for adverse maternal and infant outcomes. Women were randomized to either the patient navigation + behavioral incentives intervention (PNBI) or assessment + standard care control (ASC) group. All were followed throughout pregnancy and 12-week postpartum. Group comparisons were made using intention-to-treat and per-protocol sensitivity analyses.
RESULTS


While no group differences were found in prenatal care visits, the average number of visits for both groups (9.3 for PNBI and 8.9 for ASC) approached the American College of Obstetricians and Gynecologists (ACOG) recommended guidelines. There were also no group differences in maternal and infant outcomes. Both intention-to-treat and per-protocol sensitivity analyses, however, consistently found PNBI women attended more postpartum visits than ASC controls (p = 0.002).
CONCLUSIONS


Given ACOG's redefining of the postpartum period as the fourth trimester, study findings suggest PNBI may facilitate prevention and intervention efforts to more successfully reduce health disparities in outcomes for both mother and infant.",2022,"RESULTS


While no group differences were found in prenatal care visits, the average number of visits for both groups (9.3 for PNBI and 8.9 for ASC) approached the American College of Obstetricians and Gynecologists (ACOG) recommended guidelines.","['At-Risk Black Women', 'risk Black pregnant women', 'Participants were 150 Black pregnant women recruited at first prenatal visit and screening at risk for adverse maternal and infant outcomes']","['patient navigation + behavioral incentives intervention (PNBI) or assessment + standard care control (ASC', 'patient navigation and behavioral incentives']","['Prenatal Care Compliance', 'prenatal care visits, the average number of visits', 'prenatal care attendance']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1827763', 'cui_str': 'Prenatal visit'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",150.0,0.060444,"RESULTS


While no group differences were found in prenatal care visits, the average number of visits for both groups (9.3 for PNBI and 8.9 for ASC) approached the American College of Obstetricians and Gynecologists (ACOG) recommended guidelines.","[{'ForeName': 'Dace S', 'Initials': 'DS', 'LastName': 'Svikis', 'Affiliation': ""Department of Psychology and Institute for Women's Health, Virginia Commonwealth University, 806 W Franklin St, Richmond, VA, 23284, USA. dssvikis@vcu.edu.""}, {'ForeName': 'Sydney S', 'Initials': 'SS', 'LastName': 'Kelpin', 'Affiliation': ""Department of Psychology and Institute for Women's Health, Virginia Commonwealth University, 806 W Franklin St, Richmond, VA, 23284, USA.""}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Keyser-Marcus', 'Affiliation': 'Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Bishop', 'Affiliation': 'Department of Family Medicine and Population Health, Division of Epidemiology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Anna Beth', 'Initials': 'AB', 'LastName': 'Parlier-Ahmad', 'Affiliation': ""Department of Psychology and Institute for Women's Health, Virginia Commonwealth University, 806 W Franklin St, Richmond, VA, 23284, USA.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Jones', 'Affiliation': ""Department of Psychology and Institute for Women's Health, Virginia Commonwealth University, 806 W Franklin St, Richmond, VA, 23284, USA.""}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Villalobos', 'Affiliation': 'Department of Family Medicine and Population Health, Division of Epidemiology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Varner', 'Affiliation': 'Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Lanni', 'Affiliation': 'Department of Obstetrics and Gynecology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Karjane', 'Affiliation': 'Department of Obstetrics and Gynecology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Lauretta A', 'Initials': 'LA', 'LastName': 'Cathers', 'Affiliation': 'Department of Health-Related Sciences, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Langhorst', 'Affiliation': 'School of Social Work, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Saba W', 'Initials': 'SW', 'LastName': 'Masho', 'Affiliation': ""Institute for Women's Health, Virginia Commonwealth University, Richmond, VA, USA.""}]",Journal of racial and ethnic health disparities,['10.1007/s40615-021-00995-9']
401,33620901,Preoperative Counseling Method and Postoperative Opioid Usage: A Secondary Analysis of the PREOP Study.,"OBJECTIVE


The purpose of this analysis is to determine if postoperative opioid usage differs among women randomized to office or phone preoperative counseling for pelvic organ prolapse surgery.
METHODS


This was a planned exploratory analysis of the Patient Preparedness for Pelvic Organ Prolapse Surgery study, which randomized women to standardized preoperative counseling by office visit or phone call before prolapse surgery. Inclusion criteria were the completion of the assigned counseling intervention and submission of a 7-day postoperative pain and medication diary. Multivariable logistic regression was done to assess the association between counseling method and total opioid use while controlling for variables significant on univariate analysis (surgery type and county of residence).
RESULTS


There were 84 participants with postoperative data (41 office, 43 phone). Median total number of 5-mg oxycodone tablets used was higher for the office group (5 [interquartile range, 0-10]) than the phone group (0 [interquartile range, 0-2], P = 0.002). On multivariable logistic regression, women who underwent phone counseling were less likely to be in the highest third of opioid use when controlling for surgery type and county of residence (odds ratio, 0.23; P = 0.012; 95% confidence interval, 0.07-0.72). Daily pain scores and nonopioid medication use (nonsteroidal anti-inflammatory medications and acetaminophen) were similar between groups (P > 0.05).
CONCLUSIONS


Despite similar pain scores, women who received preoperative phone counseling before pelvic organ prolapse surgery had lower opioid utilization than those with office counseling. Further research is needed to determine the optimal method of preoperative counseling and its role in postoperative pain management.",2021,"Despite similar pain scores, women who received preoperative phone counseling before pelvic organ prolapse surgery had lower opioid utilization than those with office counseling.","['84 participants with postoperative data (41 office, 43 phone']","['standardized preoperative counseling by office visit or phone call before prolapse surgery', 'Preoperative Counseling Method and Postoperative Opioid Usage', 'phone preoperative counseling', 'preoperative phone counseling']","['Median total number of 5-mg oxycodone tablets', 'opioid utilization', 'Daily pain scores and nonopioid medication use (nonsteroidal anti-inflammatory medications and acetaminophen']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0920638', 'cui_str': 'Preoperative counseling'}, {'cui': 'C0028900', 'cui_str': 'Office visit'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0242937', 'cui_str': 'Non-opioid analgesic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]",84.0,0.141176,"Despite similar pain scores, women who received preoperative phone counseling before pelvic organ prolapse surgery had lower opioid utilization than those with office counseling.","[{'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Sassani', 'Affiliation': 'From the Division of Urogynecology, University of Pittsburgh Medical Center.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Artsen', 'Affiliation': 'From the Division of Urogynecology, University of Pittsburgh Medical Center.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Grosse', 'Affiliation': 'Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh PA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Baranski', 'Affiliation': 'From the Division of Urogynecology, University of Pittsburgh Medical Center.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Kunkle', 'Affiliation': 'From the Division of Urogynecology, University of Pittsburgh Medical Center.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Ackenbom', 'Affiliation': 'From the Division of Urogynecology, University of Pittsburgh Medical Center.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000001010']
402,33620598,"Effects of Spinal Cord Stimulation in Patients with Chronic Nausea, Vomiting, and Refractory Abdominal Pain.","BACKGROUND


Patients with chronic nausea and vomiting often also have chronic abdominal pain. Spinal cord stimulation (SCS) may provide pain control, but scarce data are available regarding the effect of SCS on chronic nausea and vomiting.
AIMS


We aimed to determine the effect of SCS in patients with chronic nausea, vomiting, and refractory abdominal pain.
METHODS


Retrospective chart review of 26 consecutive patients who underwent SCS trial for a primary diagnosis of nausea, vomiting and refractory abdominal pain.
RESULTS


26 patients underwent SCS trial, with an average age of 48 years. Twenty-three patients (88.5%) reported > 50% pain relief during the temporary SCS trial and then underwent permanent implantation. Patients were then followed for 41 (22-62) months. At baseline, 20 of the 23 patients (87.0%) reported daily nausea, but at 6 months and the most recent follow-up, only 8 (34.8%) and 7 (30.4%) patients, respectively, had daily nausea (p < 0.001). Days of nausea decreased from 26.3 days/month at baseline to 12.8 and 11.7 days/month at 6 months and at the most recent visit, respectively. Vomiting episodes decreased by 50%. Abdominal pain scores improved from 8.7 to 3.0 and 3.2 at 6 months and the most recent visit, respectively (both p < 0.001). Opioid use decreased from 57.7 mg MSO4 equivalents to 24.3 mg at 6 months and to 28.0 mg at the latest patient visit (both p < 0.05).
CONCLUSIONS


SCS may be an effective therapy for long-term treatment of symptoms for those patients afflicted with chronic nausea, vomiting, and refractory abdominal pain.",2022,"Opioid use decreased from 57.7 mg MSO4 equivalents to 24.3 mg at 6 months and to 28.0 mg at the latest patient visit (both p < 0.05).
","['26 consecutive patients who underwent SCS trial for a primary diagnosis of nausea, vomiting and refractory abdominal pain', 'Patients with chronic nausea and vomiting often also have chronic abdominal pain', 'patients with chronic nausea, vomiting, and refractory abdominal pain', '26 patients underwent SCS trial, with an average age of 48\xa0years', 'Patients with Chronic Nausea, Vomiting, and Refractory Abdominal Pain']","['Spinal cord stimulation (SCS', 'SCS', 'Spinal Cord Stimulation']","['pain relief', 'daily nausea', 'chronic nausea and vomiting', 'nausea', 'Abdominal pain scores', 'Opioid use', 'Vomiting episodes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C4047369', 'cui_str': 'Intractable abdominal pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0232491', 'cui_str': 'Chronic abdominal pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",26.0,0.117528,"Opioid use decreased from 57.7 mg MSO4 equivalents to 24.3 mg at 6 months and to 28.0 mg at the latest patient visit (both p < 0.05).
","[{'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Kapural', 'Affiliation': 'Carolinas Pain Institute, 145 Kimel Park Drive, Suite 330, Winston Salem, NC, 27103, USA. lkapuralmd@gmail.com.'}, {'ForeName': 'Bradbury Kenneth', 'Initials': 'BK', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesia, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Harandi', 'Affiliation': 'Modern Pain Management, Houston, TX, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Rejeski', 'Affiliation': 'Department of Internal Medicine, Section on Gastroenterology, Wake Forest Baptist Medical Center, Winston Salem, NC, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Koch', 'Affiliation': 'Department of Internal Medicine, Section on Gastroenterology, Wake Forest Baptist Medical Center, Winston Salem, NC, USA.'}]",Digestive diseases and sciences,['10.1007/s10620-021-06896-5']
403,33819914,The Inclusion of Sprints in Low-Intensity Sessions During the Transition Period of Elite Cyclists Improves Endurance Performance 6 Weeks Into the Subsequent Preparatory Period.,"PURPOSE


To investigate the effects of including repeated sprints in a weekly low-intensity (LIT) session during a 3-week transition period on cycling performance 6 weeks into the subsequent preparatory period (PREP) in elite cyclists.
METHODS


Eleven elite male cyclists (age = 22.0 [3.8] y, body mass = 73.0 [5.8] kg, height = 186 [7] cm, maximal oxygen uptake [VO2max] = 5469 [384] mL·min-1) reduced their training load by 64% and performed only LIT sessions (CON, n = 6) or included 3 sets of 3 × 30-second maximal sprints in a weekly LIT session (SPR, n = 5) during a 3-week transition period. There was no difference in the reduction in training load during the transition period between groups. Physiological and performance measures were compared between the end of the competitive period and 6 weeks into the PREP.
RESULTS


SPR demonstrated a 7.3% (7.2%) improvement in mean power output during a 20-minute all-out test at PREP, which was greater than CON (-1.3% [4.6%]) (P = .048). SPR had a corresponding 7.0% (3.6%) improvement in average VO2 during the 20-minute all-out test, which was larger than the 0.7% (6.0%) change in CON (P = .042). No change in VO2max, gross efficiency, or power output at blood lactate concentration of 4 mmol·L-1 from competitive period to PREP occurred in either group.
CONCLUSION


Including sprints in a weekly LIT session during the transition period of elite cyclists provided a performance advantage 6 weeks into the subsequent PREP, which coincided with a higher performance VO2.",2021,"No change in VO2max, gross efficiency, or power output at blood lactate concentration of 4 mmol·L-1 from competitive period to PREP occurred in either group.
","['Elite Cyclists', 'elite cyclists', '5469', 'Eleven elite male cyclists (age = 22.0 [3.8]\xa0y, body mass = 73.0 [5.8]\xa0kg, height = 186 [7]\xa0cm, maximal oxygen uptake [VO2max] ']",[],"['SPR', 'VO2max, gross efficiency, or power output at blood lactate concentration', 'Physiological and performance measures', 'average VO2', 'mean power output']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",[],"[{'cui': 'C0597731', 'cui_str': 'Surface Plasmon Resonance'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",11.0,0.0182386,"No change in VO2max, gross efficiency, or power output at blood lactate concentration of 4 mmol·L-1 from competitive period to PREP occurred in either group.
","[{'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Nicki', 'Initials': 'N', 'LastName': 'Almquist', 'Affiliation': ''}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Rønnestad', 'Affiliation': ''}, {'ForeName': 'Arnt Erik', 'Initials': 'AE', 'LastName': 'Tjønna', 'Affiliation': ''}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Kristoffersen', 'Affiliation': ''}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Spencer', 'Affiliation': ''}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Sandbakk', 'Affiliation': ''}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Skovereng', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0594']
404,33624527,Transcutaneous auricular vagal nerve stimulation improves functional dyspepsia by enhancing vagal efferent activity.,"This study was designed to investigate whether transcutaneous auricular vagal nerve stimulation (taVNS) would be able to improve major pathophysiologies of functional dyspepsia (FD) in patients with FD. Thirty-six patients with FD (21 F) were studied in two sessions (taVNS and sham-ES). Physiological measurements, including gastric slow waves, gastric accommodation, and autonomic functions, were assessed by the electrogastrogram (EGG), a nutrient drink test and the spectral analysis of heart rate variability derived from the electrocardiogram (ECG), respectively. Thirty-six patients with FD (25 F) were randomized to receive 2-wk taVNS or sham-ES. The dyspeptic symptom scales, anxiety and depression scores, and the same physiological measurements were assessed at the beginning and the end of the 2-wk treatment. In comparison with sham-ES, acute taVNS improved gastric accommodation ( P  = 0.008), increased the percentage of normal gastric slow waves (%NSW, fasting:  P  = 0.010; fed:  P  = 0.007) and vagal activity (fasting:  P  = 0.056; fed:  P  = 0.026). In comparison with baseline, 2-wk taVNS but not sham-ES reduced symptoms of dyspepsia ( P  = 0.010), decreased the scores of anxiety ( P  = 0.002) and depression ( P  < 0.001), and improved gastric accommodation ( P  < 0.001) and the %NSW (fasting:  P  < 0.05; fed:  P  < 0.05) by enhancing vagal efferent activity (fasting:  P  = 0.015; fed:  P  = 0.048). Compared with the HC, the patients showed increased anxiety ( P  < 0.001) and depression ( P  < 0.001), and decreased gastric accommodation ( P  < 0.001) and %NSW ( P  < 0.001) as well as decreased vagal activity (fasting:  P  = 0.047). The noninvasive taVNS has a therapeutic potential for treating nonsevere FD by improving gastric accommodation and gastric pace-making activity via enhancing vagal activity. NEW & NOTEWORTHY  Treatment of functional dyspepsia is difficult due to various pathophysiological factors. The proposed method of transcutaneous auricular vagal nerve stimulation improves symptoms of both dyspepsia and depression/anxiety, and gastric functions (accommodation and slow waves), possibly mediated via the enhancement of vagal efferent activity. This noninvasive and easy-to-implement neuromodulation method will be well received by patients and healthcare providers.",2021,"RESULTS


Acute: In comparison with sham-ES, acute taVNS improved gastric accommodation (p=0.008), increased the percentage of normal gastric slow waves (%NSW, fasting: p=0.010; fed: p=0.007) and vagal activity (fasting: p=0.056; fed: p=0.026).","['patients with FD.\nMETHODS\n\n\nAcute: Thirty-six FD patients (21F', 'Thirty-six FD patients (25F', 'Chronic']","['transcutaneous auricular vagal nerve stimulation (taVNS', 'taVNS or sham-ES', 'Transcutaneous auricular vagal nerve stimulation']","['functional dyspepsia (FD', 'gastric slow waves, gastric accommodation and autonomic functions', 'anxiety (p<0.001) and depression', 'symptoms of dyspepsia', 'depression (p<0.001), improved gastric accommodation', 'dyspeptic symptom scales, anxiety and depression scores and the same physiological measurements', 'percentage of normal gastric slow waves', 'gastric accommodation', 'scores of anxiety', 'functional dyspepsia', 'vagal activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",36.0,0.0614287,"RESULTS


Acute: In comparison with sham-ES, acute taVNS improved gastric accommodation (p=0.008), increased the percentage of normal gastric slow waves (%NSW, fasting: p=0.010; fed: p=0.007) and vagal activity (fasting: p=0.056; fed: p=0.026).","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Division of Gastroenterology, Northern Jiangsu People's Hospital, Yangzhou, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Division of Gastroenterology, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Dewen', 'Initials': 'D', 'LastName': 'Lu', 'Affiliation': 'Division of Gastroenterology, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ningbo, China.'}, {'ForeName': 'Peijing', 'Initials': 'P', 'LastName': 'Rong', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Jiafei', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Division of Gastroenterology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Division of Gastroenterology, the Affiliated Huaian No. 1 People's Hospital of Nanjing Medical University, Huaian, China.""}, {'ForeName': 'Yaoyao', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Division of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': ""Division of Gastroenterology, Northern Jiangsu People's Hospital, Yangzhou, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Division of Gastroenterology, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Division of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jiande D Z', 'Initials': 'JDZ', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, School of Medicine, University of Michigan, Ann Arbor, Michigan.'}]",American journal of physiology. Gastrointestinal and liver physiology,['10.1152/ajpgi.00426.2020']
405,33611742,Beneficial Effects of Intravenous Magnesium Administration During Robotic Radical Prostatectomy: A Randomized Controlled Trial.,"INTRODUCTION


Robotic radical prostatectomy requires prolonged pneumoperitoneum and a steep Trendelenburg position. Magnesium can attenuate the stress response and hemodynamic perturbations. This study aimed to evaluate the effects of intravenous magnesium administration on hemodynamics and the stress response in patients undergoing robotic radical prostatectomy.
METHODS


In this prospective, double-blind, randomized controlled study, 52 patients undergoing robotic radical prostatectomy were randomized into two groups: 26 in the magnesium group and 26 in the control group. The patients in the magnesium group received magnesium sulfate 50 mg/kg intravenously, followed by infusion at a rate of 10 mg/kg/h during surgery. The patients in the control group received an equal volume of 0.9% saline. The primary outcomes were the changes in heart rate and mean arterial pressure (MAP) during surgery. The serum stress hormones (adrenocorticotropic hormone, cortisol, epinephrine, and norepinephrine) were also measured.
RESULTS


MAP showed a significant intergroup difference over time (P group*time  = 0.017); it increased significantly at 5 min after Trendelenburg position in the control group and decreased significantly at 30 min after Trendelenburg position in the magnesium group. The intergroup difference in the change in cortisol concentrations was significant over time (P group*time  = 0.006). The cortisol concentration decreased significantly from baseline to 24 h after surgery in the magnesium group but did not change significantly in the control group. The requirement for intraoperative remifentanil was 35% lower in the magnesium group (P = 0.011), and the severity of postoperative pain at 30 min and 6 h after surgery was also lower in the magnesium group (P = 0.024 and P = 0.015).
CONCLUSION


There is a possibility that intravenous magnesium administration during robotic radical prostatectomy reduces the increases in arterial pressure, cortisol concentrations, opioid requirements, and postoperative pain.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02833038.",2021,"The requirement for intraoperative remifentanil was 35% lower in the magnesium group (P = 0.011), and the severity of postoperative pain at 30 min and 6 h after surgery was also lower in the magnesium group (P = 0.024 and P = 0.015).
","['52 patients undergoing robotic radical prostatectomy', 'patients undergoing robotic radical prostatectomy', 'Robotic Radical Prostatectomy']","['Robotic radical prostatectomy', 'magnesium sulfate', 'Magnesium', 'magnesium', 'equal volume of 0.9% saline', 'Intravenous Magnesium']","['serum stress hormones (adrenocorticotropic hormone, cortisol, epinephrine, and norepinephrine', 'stress response and hemodynamic perturbations', 'severity of postoperative pain', 'change in cortisol concentrations', 'arterial pressure, cortisol concentrations, opioid requirements, and postoperative pain', 'requirement for intraoperative remifentanil', 'changes in heart rate and mean arterial pressure (MAP', 'cortisol concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",52.0,0.287592,"The requirement for intraoperative remifentanil was 35% lower in the magnesium group (P = 0.011), and the severity of postoperative pain at 30 min and 6 h after surgery was also lower in the magnesium group (P = 0.024 and P = 0.015).
","[{'ForeName': 'Ha Yeon', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, South Korea.'}, {'ForeName': 'Sook Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, South Korea.'}, {'ForeName': 'Hye Sun', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Bo Kyeong', 'Initials': 'BK', 'LastName': 'Jun', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, South Korea.'}, {'ForeName': 'Jong Bum', 'Initials': 'JB', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, South Korea.'}, {'ForeName': 'Ji Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, South Korea. beye98@aumc.ac.kr.'}]",Advances in therapy,['10.1007/s12325-021-01643-8']
406,33638108,Comparison of three-dimensional (3D) endovision system versus ultra-high-definition 4K endovision system in minimally invasive surgical procedures: a randomized-open label pilot study.,"BACKGROUND


Experimental work comparing 3-Dimensional (3D) and 4K ultra-high-definition endovision system (4K) indicates that the latter with double the resolution of standard 2D high-definition systems may provide additional visual cues to compensate for the lack of stereoscopic vision. There is paucity of studies comparing 3D and 4K system in clinical settings. This randomized study compares 3D and 4K systems in three laparoscopic procedures of increasing complexity.
METHODS


139 patients undergoing laparoscopic cholecystectomy (60 patients), transabdominal preperitoneal (TAPP) repair (49 patients) and laparoscopic Heller's cardiomyotomy with anti- reflux procedure (30 patients) between May 2018 and February 2020 were randomized to undergo surgery using either 3D or 4K systems. Primary objective was to measure total operative time. Secondary objectives were to compare workload perceived by surgeons using SURG-TLX and surgeon satisfaction score. Timings of key surgical steps and peri-operative course of the patients was also recorded. Data were analyzed using Stata Corp. 2015.
RESULTS


Patients undergoing surgery with 3D and 4K systems were comparable in their clinical and demographic profiles. The mean total operative time in 3D and 4K groups was comparable in cholecystectomy (52.7 vs 56.2, p = 0.50), TAPP (63.8 vs 69.6, p = 0.25) and Heller's cardiomyotomy (124.7 vs 143.3, p = 0.14) with faster hiatal dissection in 3D group (8 min, p = 0.02). Operative time was better in patients undergoing Heller's myotomy with Angle of His accentuation with 3D by 28 min (p = 0.03). Total workload was similar in 3D and 4K groups in all the procedures but mental & physical demand was lower in 3D group in Heller's cardiomyotomy (p = 0.03, p = 0.01), Surgeon satisfaction score was comparable in all three procedures.
CONCLUSION


Overall, 3D HD and 4K systems are comparable in performing laparoscopic cholecystectomy, TAPP and Heller's Cardiomyotomy. Hiatal dissection time, mental and physical task load was better with 3D in Heller's Cardiomyotomy.",2022,Total workload was similar in 3D and 4K groups in all the procedures but mental & physical demand was lower in 3D group in Heller's cardiomyotomy (,"['139 patients undergoing', '60 patients', 'Patients undergoing surgery with 3D and 4K systems', 'minimally invasive surgical procedures', '30 patients) between May 2018 and February 2020']","['3-Dimensional (3D) and 4K ultra-high-definition endovision system (4K', 'three-dimensional (3D) endovision system versus ultra-high-definition 4K endovision system', ""transabdominal preperitoneal (TAPP) repair (49 patients) and laparoscopic Heller's cardiomyotomy with anti- reflux procedure"", 'laparoscopic cholecystectomy', 'TAPP ']","['mean total operative time', 'Total workload', 'total operative time', 'Operative time', 'workload perceived by surgeons using SURG-TLX and surgeon satisfaction score', ""Heller's cardiomyotomy"", 'Surgeon satisfaction score', 'Hiatal dissection time, mental and physical task load']","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4505238', 'cui_str': 'Laparoscopic Heller Cardiomyotomy'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1505678', 'cui_str': 'CD46 protein, human'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0192265', 'cui_str': 'Esophagomyotomy'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",139.0,0.0598975,Total workload was similar in 3D and 4K groups in all the procedures but mental & physical demand was lower in 3D group in Heller's cardiomyotomy (,"[{'ForeName': 'Rajinder', 'Initials': 'R', 'LastName': 'Parshad', 'Affiliation': 'Department of Surgical disciplines, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Shashikiran', 'Initials': 'S', 'LastName': 'Nanjakla Jayappa', 'Affiliation': 'Department of Surgical disciplines, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India. shashikiran.nj@gmail.com.'}, {'ForeName': 'Hemanga Kumar', 'Initials': 'HK', 'LastName': 'Bhattacharjee', 'Affiliation': 'Department of Surgical disciplines, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Suhani', 'Initials': 'S', 'LastName': 'Suhani', 'Affiliation': 'Department of Surgical disciplines, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Mohit Kumar', 'Initials': 'MK', 'LastName': 'Joshi', 'Affiliation': 'Department of Surgical disciplines, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Debesh', 'Initials': 'D', 'LastName': 'Bhoi', 'Affiliation': 'Department of Surgical disciplines, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Lokesh', 'Initials': 'L', 'LastName': 'Kashyap', 'Affiliation': 'Department of Surgical disciplines, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}]",Surgical endoscopy,['10.1007/s00464-021-08377-2']
407,33630639,Promotion of physical activity during weight loss maintenance: A randomized controlled trial.,"OBJECTIVE


Behavioral weight loss (BWL) programs are not sufficiently effective at promoting high levels of moderate-to-vigorous physical activity (MVPA), despite the clear health benefits of exercise and the possibility that high levels of MVPA may improve long-term weight loss. This three-arm randomized controlled trial tested the hypotheses that 1) BWL interventions with an intensive focus on exercise would result in higher amounts of MVPA and greater long-term weight loss, compared to standard BWL, and 2) among interventions with an intensive focus on exercise, outcomes would be superior when skills for exercise promotion were taught from an acceptance-based theoretical framework (which fosters willingness to accept discomfort in the service of valued behaviors), versus a traditional behavioral approach.
METHOD


Three hundred and twenty adults with overweight/obesity received group-based BWL for induction of weight loss (Months 1-6) and were randomized to receive one of three interventions for weight loss maintenance (Months 7-18): continued standard behavioral treatment (BT), behavioral treatment with an emphasis on exercise (BT + PA), or acceptance-based treatment with an emphasis on exercise (ABT + PA).
RESULTS


MVPA and percent weight loss did not significantly differ by condition at 12 or 18 months. Participants engaging in relatively higher levels of MVPA had greater long-term weight losses compared to participants engaging in lower levels of MVPA.
CONCLUSIONS


Further clinical innovations are needed so that participants in BWL programs can more readily adopt and maintain the recommended amounts of MVPA. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Participants engaging in relatively higher levels of MVPA had greater long-term weight losses compared to participants engaging in lower levels of MVPA.
",['Three hundred and twenty adults with overweight/obesity received group-based BWL for induction of weight loss (Months 1-6'],"['three interventions for weight loss maintenance (Months 7-18): continued standard behavioral treatment (BT), behavioral treatment with an emphasis on exercise (BT + PA), or acceptance-based treatment with an emphasis on exercise (ABT + PA']","['weight loss', 'long-term weight losses']","[{'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0045246', 'cui_str': ""2,2'-azino-di-(3-ethylbenzothiazoline)-6-sulfonic acid""}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",320.0,0.0921816,"Participants engaging in relatively higher levels of MVPA had greater long-term weight losses compared to participants engaging in lower levels of MVPA.
","[{'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'Center for WorkLife Wellbeing, ChristianaCare.'}, {'ForeName': 'Christine C', 'Initials': 'CC', 'LastName': 'Call', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University.'}, {'ForeName': 'Fengqing', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, Drexel University.'}, {'ForeName': 'Stella L', 'Initials': 'SL', 'LastName': 'Volpe', 'Affiliation': 'Department of Nutrition Sciences, Drexel University.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0001043']
408,33637544,Peer-Assisted Lifestyle (PAL) intervention: a protocol of a cluster-randomised controlled trial of a health-coaching intervention delivered by veteran peers to improve obesity treatment in primary care.,"INTRODUCTION


Among US veterans, more than 78% have a body mass index (BMI) in the overweight (≥25 kg/m 2 ) or obese range (≥30 kg/m 2 ). Clinical guidelines recommend multicomponent lifestyle programmes to promote modest, clinically significant body mass (BM) loss. Primary care providers (PCPs) often lack time to counsel and refer patients to intensive programmes (≥6 sessions over 3 months). Using peer coaches to deliver obesity counselling in primary care may increase patient motivation, promote behavioural change and address the specific needs of veterans. We describe the rationale and design of a cluster-randomised controlled trial to test the efficacy of the Peer-Assisted Lifestyle (PAL) intervention compared with enhanced usual care (EUC) to improve BM loss, clinical and behavioural outcomes (aim 1); identify BM-loss predictors (aim 2); and increase PCP counselling (aim 3).
METHODS AND ANALYSIS


We are recruiting 461 veterans aged 18-69 years with obesity or overweight with an obesity-associated condition under the care of a PCP at the Brooklyn campus of the Veterans Affairs NY Harbor Healthcare System. To deliver counselling, PAL uses in-person and telephone-based peer support, a tablet-delivered goal-setting tool and PCP training. Patients in the EUC arm receive non-tailored healthy living handouts. In-person data collection occurs at baseline, month 6 and month 12 for patients in both arms. Repeated measures modelling based on mixed models will compare mean BM loss (primary outcome) between study arms.
ETHICS AND DISSEMINATION


The protocol has been approved by the Institutional Review Board and the Research and Development Committee at the VA NY Harbor Health Systems (#01607). We will disseminate the results via peer-reviewed publications, conference presentations and meetings with stakeholders.
TRIAL REGISTRATION NUMBER


NCT03163264; Pre-results.",2021,"Using peer coaches to deliver obesity counselling in primary care may increase patient motivation, promote behavioural change and address the specific needs of veterans.","['461 veterans aged 18-69 years with obesity or overweight with an obesity-associated condition under the care of a PCP at the Brooklyn campus of the Veterans Affairs NY Harbor Healthcare System', 'US veterans, more than 78% have a body mass index (BMI) in the overweight', 'veteran peers to improve obesity treatment in primary care']","['Peer-Assisted Lifestyle (PAL) intervention', 'enhanced usual care (EUC', 'health-coaching intervention', 'EUC arm receive non-tailored healthy living handouts']","['BM loss, clinical and behavioural outcomes', 'mean BM loss']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0996201,"Using peer coaches to deliver obesity counselling in primary care may increase patient motivation, promote behavioural change and address the specific needs of veterans.","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Wittleder', 'Affiliation': 'Department of Medicine, New York University School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Shea', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, New York University School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Binhuan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Jeannette M', 'Initials': 'JM', 'LastName': 'Beasley', 'Affiliation': 'Department of Medicine, New York University School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Orstad', 'Affiliation': 'Department of Medicine, New York University School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Sweat', 'Affiliation': 'Department of Medicine, New York University School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Squires', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York City, New York, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine, New York University School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Doebrich', 'Affiliation': 'Department of Medicine, New York University School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Damara', 'Initials': 'D', 'LastName': 'Gutnick', 'Affiliation': 'Department of Epidemiology & Population Health, Department of Family & Social Medicine, Department of Psychiatry & Behavioral Sciences, The Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Tenner', 'Affiliation': 'Department of Medicine, New York University School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'Veterans Affairs New York Harbor Healthcare System, Veterans Health Administration, New York City, New York, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Jay', 'Affiliation': 'Veterans Affairs New York Harbor Healthcare System, Veterans Health Administration, New York City, New York, USA melanie.jay@nyulangone.org.'}]",BMJ open,['10.1136/bmjopen-2020-043013']
409,33632748,Improving Pediatric Resident Safety Event Reporting Using Quality Improvement Methods.,"BACKGROUND AND OBJECTIVES


Safety event reporting systems facilitate identification of system-level targets to improve patient safety. Resident physicians report few safety events despite their role as frontline providers and the frequent occurrence of events. The objective of this study is to increase the number of pediatric resident safety event submissions from <1 to 4 submissions per 14-day period within 12 months.
METHODS


We conducted an iterative quality improvement process with 39 pediatric residents at a children's hospital. Interventions focused on 4 key drivers: user-friendly event submission process, resident buy-in, nonpunitive safety culture, and data transparency. The primary outcome measure of number of pediatric resident event submissions was analyzed by using statistical process control. Balancing measures included time from submission to feedback, duplicate submissions, and nonevent submissions. As a control, the primary outcome measure was monitored for nonpediatric residents during the same period.
RESULTS


The mean number of pediatric resident event submissions increased from 0.9 to 5.7 submissions per 14 days. Impactful interventions included a designated space in the resident workroom to list safety events to submit, monthly project updates, and an interresident competition. There were no duplicate submissions or nonevent submissions in the postintervention period. Time to feedback in the postintervention period had both upward and downward shifts, with >8 consecutive points above and below the baseline period's centerline. The control group showed no sustained change in event submissions.
CONCLUSIONS


Our improvement process was associated with significant increase in pediatric resident safety event submissions without an increase in the number of submissions categorized as duplicates or nonevents.",2021,Our improvement process was associated with significant increase in pediatric resident safety event submissions without an increase in the number of submissions categorized as duplicates or nonevents.,"[""39 pediatric residents at a children's hospital""]","['4 key drivers: user-friendly event submission process, resident buy-in, nonpunitive safety culture, and data transparency']","['sustained change in event submissions', 'mean number of pediatric resident event submissions', 'number of pediatric resident event submissions', 'time from submission to feedback, duplicate submissions, and nonevent submissions', 'pediatric resident safety event submissions']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4045992', 'cui_str': 'Safety Culture'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",39.0,0.0430886,Our improvement process was associated with significant increase in pediatric resident safety event submissions without an increase in the number of submissions categorized as duplicates or nonevents.,"[{'ForeName': 'Monica D', 'Initials': 'MD', 'LastName': 'Mattes', 'Affiliation': 'Department of Pediatrics, University of California Davis, Sacramento, California; and monica.mattes@gmail.com.'}, {'ForeName': 'Hadley S', 'Initials': 'HS', 'LastName': 'Sauers-Ford', 'Affiliation': 'Department of Pediatrics, University of California Davis, Sacramento, California; and.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Selleck', 'Affiliation': 'University of California Davis Health, Sacramento, California.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Slee', 'Affiliation': 'University of California Davis Health, Sacramento, California.'}, {'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Natale', 'Affiliation': 'Department of Pediatrics, University of California Davis, Sacramento, California; and.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Pediatrics, University of California Davis, Sacramento, California; and.'}]",Hospital pediatrics,['10.1542/hpeds.2020-001081']
410,33626197,A phase 3 trial of azacitidine versus a semi-intensive fludarabine and cytarabine schedule in older patients with untreated acute myeloid leukemia.,"BACKGROUND


Options to treat elderly patients (≥65 years old) newly diagnosed with acute myeloid leukemia (AML) include intensive and attenuated chemotherapy, hypomethylating agents with or without venetoclax, and supportive care. This multicenter, randomized, open-label, phase 3 trial was designed to assess the efficacy and safety of a fludarabine, cytarabine, and filgrastim (FLUGA) regimen in comparison with azacitidine (AZA).
METHODS


Patients (n = 283) were randomized 1:1 to FLUGA (n = 141) or AZA (n = 142). Response was evaluated after cycles 1, 3, 6, and 9. Measurable residual disease (MRD) was assessed after cycle 9. When MRD was ≥0.01%, patients continued with the treatment until relapse or progressive disease. Patients with MRD < 0.01% suspended treatment to enter the follow-up phase.
RESULTS


The complete remission (CR) rate after 3 cycles was significantly better in the FLUGA arm (18% vs 9%; P = .04), but the CR/CR with incomplete recovery rate at 9 months was similar (33% vs 29%; P = .41). There were no significant differences between arms in early mortality at 30 or 60 days. Hematologic toxicities were more frequent with FLUGA, especially during induction. The 1-year overall survival (OS) rate and the median OS were superior with AZA versus FLUGA: 47% versus 27% and 9.8 months (95% confidence interval [CI], 5.6-14 months) versus 4.1 months (95% CI, 2.7-5.5 months; P = .005), respectively. The median event-free survival was 4.9 months (95% CI, 2.8-7 months) with AZA and 3 months (95% CI, 2.5-3.5 months) with FLUGA (P = .001).
CONCLUSIONS


FLUGA achieved more remissions after 3 cycles, but the 1-year OS rate was superior with AZA. However, long-term outcomes were disappointing in both arms (3-year OS rate, 10% vs 5%). This study supports the use of an AZA backbone for future combinations in elderly patients with AML.",2021,"The median event-free survival was 4.9 months (95% CI, 2.8-7 months) with AZA and 3 months (95% CI, 2.5-3.5 months) with FLUGA (P =","['Patients (n = 283', 'older patients with untreated acute myeloid leukemia', 'elderly patients (≥65 years old) newly diagnosed with acute myeloid leukemia (AML) include intensive and attenuated chemotherapy, hypomethylating agents with or without venetoclax, and supportive care', 'elderly patients with AML', 'comparison with azacitidine (AZA']","['AZA versus FLUGA', 'FLUGA', 'AZA backbone', 'azacitidine', 'semi-intensive fludarabine and cytarabine', 'AZA', 'fludarabine, cytarabine, and filgrastim (FLUGA']","['Hematologic toxicities', '1-year overall survival (OS) rate and the median OS', 'median event-free survival', 'complete remission (CR) rate', 'early mortality', 'efficacy and safety', '1-year OS rate', 'Measurable residual disease (MRD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}]","[{'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}]","[{'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}]",283.0,0.14715,"The median event-free survival was 4.9 months (95% CI, 2.8-7 months) with AZA and 3 months (95% CI, 2.5-3.5 months) with FLUGA (P =","[{'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Vives', 'Affiliation': ""Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Badalona, Spain.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Martínez-Cuadrón', 'Affiliation': 'Hospital Universitari i Politècnic La Fe, Valencia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Bergua Burgues', 'Affiliation': 'Hospital San Pedro Alcántara, Cáceres, Spain.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Algarra', 'Affiliation': 'Hospital General de Albacete, Albacete, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Tormo', 'Affiliation': 'Hospital Clínic de Valencia (INCLIVA), Valencia, Spain.'}, {'ForeName': 'María Pilar', 'Initials': 'MP', 'LastName': 'Martínez-Sánchez', 'Affiliation': 'Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Serrano', 'Affiliation': 'Hospital Universitario Reina Sofía, Córdoba, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Herrera', 'Affiliation': 'Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ramos', 'Affiliation': 'Hospital Universitario de León, León, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Salamero', 'Affiliation': ""Hospital Vall d'Hebrón-VHIO, Barcelona, Spain.""}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Lavilla', 'Affiliation': 'Hospital Universitario Lucus Agusti, Lugo, Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'López-Lorenzo', 'Affiliation': 'Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gil', 'Affiliation': 'Hospital General Universitario de Alicante, Alicante, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Vidriales', 'Affiliation': 'Hospital Universitario de Salamanca, IBSAL, Salamanca, Spain.'}, {'ForeName': 'Jose F', 'Initials': 'JF', 'LastName': 'Falantes', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla, Seville, Spain.'}, {'ForeName': 'Alfons', 'Initials': 'A', 'LastName': 'Serrano', 'Affiliation': 'Hospital Universitario HM San Chinarro, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Labrador', 'Affiliation': 'Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Sayas', 'Affiliation': 'Hospital Doctor Peset, Valencia, Spain.'}, {'ForeName': 'María Á', 'Initials': 'MÁ', 'LastName': 'Foncillas', 'Affiliation': 'Hospital Universitario Infanta Leonor, Madrid, Spain.'}, {'ForeName': 'María L', 'Initials': 'ML', 'LastName': 'Amador Barciela', 'Affiliation': 'Hospital Montecelo, Pontevedra, Spain.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Olave', 'Affiliation': 'Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Colorado', 'Affiliation': 'Hospital Universitario Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Gascón', 'Affiliation': 'Hospital General Universitari de Castelló, Castelló, Spain.'}, {'ForeName': 'María Á', 'Initials': 'MÁ', 'LastName': 'Fernández', 'Affiliation': 'Hospital Xeral Cíes, Vigo, Spain.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Simiele', 'Affiliation': 'Hospital Povisa, Vigo, Spain.'}, {'ForeName': 'Manuel M', 'Initials': 'MM', 'LastName': 'Pérez-Encinas', 'Affiliation': 'Hospital Clínico Universitario de Santiago, A Coruña, Spain.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Rodríguez-Veiga', 'Affiliation': 'Hospital Universitari i Politècnic La Fe, Valencia, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'García', 'Affiliation': ""Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Badalona, Spain.""}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Martínez-López', 'Affiliation': 'Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Barragán', 'Affiliation': 'Hospital Universitari i Politècnic La Fe, Valencia, Spain.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Paiva', 'Affiliation': 'Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.'}, {'ForeName': 'Miguel Á', 'Initials': 'MÁ', 'LastName': 'Sanz', 'Affiliation': 'Hospital Universitari i Politècnic La Fe, Valencia, Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'Hospital Universitari i Politècnic La Fe, Valencia, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cancer,['10.1002/cncr.33403']
411,33638647,Effect of a church-based intervention on abstinence communication among African-American caregiver-child dyads: the role of gender of caregiver and child.,"Parent-child sexual-health communication is critical. Religious involvement is important in many African-American families, but can be a barrier to sexual-health communication. We tested a theory-based, culturally tailored intervention to increase sexual-abstinence communication among church-attending African-American parent-child dyads. In a randomized controlled trial, 613 parent-child dyads were randomly assigned to one of three 3-session interventions: (i) faith-based abstinence-only; (ii) non-faith-based abstinence-only; or (iii) attention-matched health-promotion control. Data were collected pre- and post-intervention, and 3-, 6-, 12- and 18-months post-intervention. Generalized-estimating-equations Poisson-regression models revealed no differences in communication by intervention arm. However, three-way condition � sex-of-child � sex-of-parent interactions on children's reports of parent-child communication about puberty [IRR=0.065, 95% CI: (0.010, 0.414)], menstruation or wet dreams [IRR=0.103, 95% CI: (0.013, 0.825)] and dating [IRR=0.102, 95% CI: (0.016, 0.668)] indicated that the non-faith-based abstinence intervention's effect on increasing communication was greater with daughters than with sons, when the parent was the father. This study highlights the importance of considering parent and child gender in the efficacy of parent-child interventions and the need to tailor interventions to increase fathers' comfort with communication.",2021,Generalized-estimating-equations Poisson-regression models revealed no differences in communication by intervention arm.,"['613 parent-child dyads', 'African-American caregiver-child dyads', 'church-attending African-American parent-child dyads']","['church-based intervention', 'culturally tailored intervention', '3-session interventions: (i) faith-based abstinence-only; (ii) non-faith-based abstinence-only; or (iii) attention-matched health-promotion control']","['sexual-abstinence communication', 'abstinence communication', 'menstruation or wet dreams']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0233931', 'cui_str': 'Nocturnal emission'}]",613.0,0.0304318,Generalized-estimating-equations Poisson-regression models revealed no differences in communication by intervention arm.,"[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Cederbaum', 'Affiliation': 'University of Southern California, Suzanne Dworak-Peck School of Social Work, 669 W. 34th Street, MRF 222, Los Angeles, CA 90089, USA.'}, {'ForeName': 'Soojong', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Annenberg School of Communication, 3901 Walnut Street, Suite 500, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'University of California, Davis, Department of Communication. One Shields Ave. Davis, CA 95616, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Jemmott', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine and Annenberg School of Communication, 3901 Walnut Street, Suite 500, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Loretta S', 'Initials': 'LS', 'LastName': 'Jemmott', 'Affiliation': 'Drexel University, College of Nursing and Health Professions, 1601 Cherry Street, Philadelphia, PA 19102, USA.'}]",Health education research,['10.1093/her/cyab009']
412,33626506,Recovery Kinetics Following Small-Sided Games in Competitive Soccer Players: Does Player Density Size Matter?,"PURPOSE


To examine the recovery kinetics of exercise-induced muscle damage (EIMD), neuromuscular fatigue, and performance following small-sided games (SSGs) of different densities in soccer.
METHODS


Ten male players randomly completed 3 trials: a control trial (no SSGs), 4v4 SSGs (62.5 m2/player), and 8v8 SSGs (284.4 m2/player). External and internal load were monitored using GPS technology, heart-rate monitors, and rating of perceived exertion. Delayed-onset muscle soreness (DOMS), creatine kinase (CK), isokinetic strength, countermovement jump (CMJ), and sprint were determined at baseline, as well as at 24, 48, and 72 hours post-SSGs. Neuromuscular fatigue was assessed at baseline and at 1, 2, and 3 hours post-SSGs.
RESULTS


DOMS increased (P < .05) in 4v4 for 72 hours and in 8v8 for 24 hours with that of knee flexors being more pronounced than that of extensors. CK increased (P < .05) in 4v4 for 72 hours and in 8v8 for 24 hours. Neuromuscular fatigue increased (P < .05) in 4v4 for 2 hours and in 8v8 for 3 hours. Strength declined (P < .05) in 4v4 for 48 hours and in 8v8 for 72 hours. CMJ decreased (P < .05) in 4v4 for 24 hours and in 8v8 for 48 hours. Sprint decreased (P < .05) for 48 hours in 4v4 and for 72 hours in 8v8.
CONCLUSIONS


SSGs are associated with a prolonged rise of EIMD and induce short-term neuromuscular fatigue and slow recovery kinetics of strength, jump, and sprinting performance. The time for complete recovery is longer for SSGs of lower density.",2021,CK increased (P < .05) in 4v4 for 72 hours and in 8v8 for 24 hours.,"['Ten male players randomly completed 3 trials: a control trial (no SSGs), 4v4 SSGs (62.5 m2/player), and 8v8 SSGs (284.4 m2/player', 'Competitive Soccer Players', 'small-sided games (SSGs) of different densities in soccer']",[],"['recovery kinetics of exercise-induced muscle damage (EIMD), neuromuscular fatigue, and performance', 'DOMS', 'Neuromuscular fatigue', 'Delayed-onset muscle soreness (DOMS), creatine kinase (CK), isokinetic strength, countermovement jump (CMJ), and sprint', 'CK', 'Recovery Kinetics', 'CMJ']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",[],"[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",10.0,0.0546845,CK increased (P < .05) in 4v4 for 72 hours and in 8v8 for 24 hours.,"[{'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Papanikolaou', 'Affiliation': ''}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Tsimeas', 'Affiliation': ''}, {'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Anagnostou', 'Affiliation': ''}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Varypatis', 'Affiliation': ''}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Mourikis', 'Affiliation': ''}, {'ForeName': 'Theofanis', 'Initials': 'T', 'LastName': 'Tzatzakis', 'Affiliation': ''}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Draganidis', 'Affiliation': ''}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Batsilas', 'Affiliation': ''}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Mersinias', 'Affiliation': ''}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Loules', 'Affiliation': ''}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Poulios', 'Affiliation': ''}, {'ForeName': 'Chariklia K', 'Initials': 'CK', 'LastName': 'Deli', 'Affiliation': ''}, {'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Batrakoulis', 'Affiliation': ''}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Chatzinikolaou', 'Affiliation': ''}, {'ForeName': 'Magni', 'Initials': 'M', 'LastName': 'Mohr', 'Affiliation': ''}, {'ForeName': 'Athanasios Z', 'Initials': 'AZ', 'LastName': 'Jamurtas', 'Affiliation': ''}, {'ForeName': 'Ioannis G', 'Initials': 'IG', 'LastName': 'Fatouros', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0380']
413,33629376,Vegan dietary pattern for the primary and secondary prevention of cardiovascular diseases.,"BACKGROUND


Diet plays a major role in the aetiology of cardiovascular disease (CVD) and as a modifiable risk factor is the focus of many prevention strategies. Recently vegan diets have gained popularity and there is a need to synthesise existing clinical trial evidence for their potential in CVD prevention.
OBJECTIVES


To determine the effectiveness of following a vegan dietary pattern for the primary and secondary prevention of CVD.
SEARCH METHODS


We searched the following electronic databases on 4 February 2020: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and Web of Science Core Collection. We also searched ClinicalTrials.gov in January 2021. We applied no language restrictions.
SELECTION CRITERIA


We selected randomised controlled trials (RCTs) in healthy adults and adults at high risk of CVD (primary prevention) and those with established CVD (secondary prevention). A vegan dietary pattern excludes meat, fish, eggs, dairy and honey; the intervention could be dietary advice, provision of relevant foods, or both. The comparison group received either no intervention, minimal intervention, or another dietary intervention. Outcomes included clinical events and CVD risk factors. We included only studies with follow-up periods of 12 weeks or more, defined as the intervention period plus post-intervention follow-up.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed studies for inclusion, extracted data and assessed risks of bias. We used GRADE to assess the certainty of the evidence. We conducted three main comparisons: 1. Vegan dietary intervention versus no intervention or minimal intervention for primary prevention; 2. Vegan dietary intervention versus another dietary intervention for primary prevention; 3. Vegan dietary intervention versus another dietary intervention for secondary prevention.
MAIN RESULTS


Thirteen RCTs (38 papers, 7 trial registrations) and eight ongoing trials met our inclusion criteria. Most trials contributed to primary prevention: comparisons 1 (four trials, 466 participants randomised) and comparison 2 (eight trials, 409 participants randomised). We included only one secondary prevention trial for comparison 3 (63 participants randomised). None of the trials reported on clinical endpoints. Other primary outcomes included lipid levels and blood pressure. For comparison 1 there was moderate-certainty evidence from four trials with 449 participants that a vegan diet probably led to a small reduction in total cholesterol (mean difference (MD) -0.24 mmol/L, 95% confidence interval (CI) -0.36 to -0.12) and low-density lipoprotein (LDL) cholesterol (MD -0.22 mmol/L, 95% CI -0.32 to -0.11), a very small decrease in high-density lipoprotein (HDL) levels (MD -0.08 mmol/L, 95% CI -0.11 to -0.04) and a very small increase in triglyceride levels (MD 0.11 mmol/L, 95% CI 0.01 to 0.21). The very small changes in HDL and triglyceride levels are in the opposite direction to that expected. There was a lack of evidence for an effect with the vegan dietary intervention on systolic blood pressure (MD 0.94 mmHg, 95% CI -1.18 to 3.06; 3 trials, 374 participants) and diastolic blood pressure (MD -0.27 mmHg, 95% CI -1.67 to 1.12; 3 trials, 372 participants) (low-certainty evidence). For comparison 2 there was a lack of evidence for an effect of the vegan dietary intervention on total cholesterol levels (MD -0.04 mmol/L, 95% CI -0.28 to 0.20; 4 trials, 163 participants; low-certainty evidence). There was probably little or no effect of the vegan dietary intervention on LDL (MD -0.05 mmol/L, 95% CI -0.21 to 0.11; 4 trials, 244 participants) or HDL cholesterol levels (MD -0.01 mmol/L, 95% CI -0.08 to 0.05; 5 trials, 256 participants) or triglycerides (MD 0.21 mmol/L, 95% CI -0.07 to 0.49; 5 trials, 256 participants) compared to other dietary interventions (moderate-certainty evidence). We are very uncertain about any effect of the vegan dietary intervention on systolic blood pressure (MD 0.02 mmHg, 95% CI -3.59 to 3.62)  or diastolic blood pressure (MD 0.63 mmHg, 95% CI -1.54 to 2.80; 5 trials, 247 participants (very low-certainty evidence)). Only one trial (63 participants) contributed to comparison 3, where there was a lack of evidence for an effect of the vegan dietary intervention on lipid levels or blood pressure compared to other dietary interventions (low- or very low-certainty evidence). Four trials reported on adverse events, which were absent or minor.
AUTHORS' CONCLUSIONS


Studies were generally small with few participants contributing to each comparison group. None of the included studies report on CVD clinical events. There is currently insufficient information to draw conclusions about the effects of vegan dietary interventions on CVD risk factors. The eight ongoing studies identified will add to the evidence base, with all eight reporting on primary prevention. There is a paucity of evidence for secondary prevention.",2021,"There was a lack of evidence for an effect with the vegan dietary intervention on systolic blood pressure (MD 0.94 mmHg, 95% CI -1.18 to 3.06; 3 trials, 374 participants) and diastolic blood pressure (MD -0.27 mmHg, 95% CI -1.67 to 1.12; 3 trials, 372 participants) (low-certainty evidence).","['healthy adults and adults at high risk of CVD (primary prevention) and those with established CVD (secondary prevention', 'primary prevention', '466 participants randomised) and comparison 2 (eight trials, 409 participants randomised']","['vegan dietary intervention', 'vegan dietary interventions', 'no intervention, minimal intervention, or another dietary intervention', 'Vegan dietary intervention versus another dietary intervention', 'Vegan dietary intervention versus no intervention or minimal intervention']","['HDL and triglyceride levels', 'systolic blood pressure', 'cardiovascular diseases', 'high-density lipoprotein (HDL) levels', 'total cholesterol levels', 'HDL cholesterol levels', 'low-density lipoprotein (LDL) cholesterol', 'clinical events and CVD risk factors', 'lipid levels or blood pressure', 'triglyceride levels', 'adverse events', 'lipid levels and blood pressure', 'diastolic blood pressure', 'LDL', 'total cholesterol']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0679699', 'cui_str': 'Secondary prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0344353', 'cui_str': 'Vegan'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",63.0,0.333201,"There was a lack of evidence for an effect with the vegan dietary intervention on systolic blood pressure (MD 0.94 mmHg, 95% CI -1.18 to 3.06; 3 trials, 374 participants) and diastolic blood pressure (MD -0.27 mmHg, 95% CI -1.67 to 1.12; 3 trials, 372 participants) (low-certainty evidence).","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rees', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Al-Khudairy', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Takeda', 'Affiliation': 'Cochrane ENT, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Stranges', 'Affiliation': 'Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Canada.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013501.pub2']
414,33634747,Effects of Mulligan Mobilization with Movement in Subacute Lateral Ankle Sprains: A Pragmatic Randomized Trial.,"Objective : In a pragmatic and randomized clinical trial, patients with lateral ankle sprains were assessed, under blinded conditions, for their responsiveness and improvements during Mulligan mobilization-with-movement (MWM) therapy.  Methods : Overall, 51 participants with subacute lateral ankle sprains (Grade I-II) were recruited. Following an MWM screening procedure, responders were randomized to either an intervention group (MWM) or a sham group. The MWM group received inferior tibiofibular, talocrural, or cubometatarsal MWM. The treatment or sham was administered upon three sessions, each 4 days apart. Changes from baseline were measured and compared between the sessions for dorsiflexion range of motion, pain, stiffness perception, and the Y-balance test.  Results : In total, 43 participants were considered responders to MWM. Using a two-way repeated-measure ANOVA, a statistical and clinically meaningful improvement in dorsiflexion range of motion was revealed in the MWM group (p = 0.004, 1 rst  = +1.762 cm; 3 rd  = +2.714 cm), whereas no improvement following the first session occurred in the sham group (p = 0.454, 1 rst trial = +1.091 cm; 3 rd trial = +1.409 cm). Pain and stiffness significantly improved, yet below the clinically meaningful level. The MWM group demonstrated a significant improvement after three sessions for the Y-balance test (p = 0.001, +8.857 cm).  Conclusion : More than 80% of participants with subacute lateral ankle sprains responded well to the MWM approach. Three sessions of pragmatically determined MWM provided a significant and clinically meaningful benefit in dorsiflexion range of motion and Y-balance test performance compared to a sham treatment.",2021,Three sessions of pragmatically determined MWM provided a significant and clinically meaningful benefit in dorsiflexion range of motion and Y-balance test performance compared to a sham treatment.,"['43 participants were considered responders to MWM', 'patients with lateral ankle sprains', 'participants with subacute lateral ankle sprains', 'Subacute Lateral Ankle Sprains', '51 participants with subacute lateral ankle sprains (Grade I-II) were recruited']","['intervention group (MWM) or a\xa0sham group', 'Mulligan Mobilization with Movement', 'inferior tibiofibular, talocrural, or cubometatarsal MWM', 'Mulligan mobilization-with-movement\xa0(MWM) therapy']","['Pain and stiffness', 'dorsiflexion range of motion', 'dorsiflexion range of motion, pain, stiffness perception, and the Y-balance test', 'dorsiflexion range of motion and Y-balance test performance']","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",43.0,0.34662,Three sessions of pragmatically determined MWM provided a significant and clinically meaningful benefit in dorsiflexion range of motion and Y-balance test performance compared to a sham treatment.,"[{'ForeName': 'Anh Phong', 'Initials': 'AP', 'LastName': 'Nguyen', 'Affiliation': 'Université Catholique de Louvain, Institut de Recherche Expérimentale et Clinique, Neuromusculoskeletal lab, Brussels, Belgium.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Pitance', 'Affiliation': 'Université Catholique de Louvain, Institut de Recherche Expérimentale et Clinique, Neuromusculoskeletal lab, Brussels, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Mahaudens', 'Affiliation': 'Université Catholique de Louvain, Institut de Recherche Expérimentale et Clinique, Neuromusculoskeletal lab, Brussels, Belgium.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Detrembleur', 'Affiliation': 'Université Catholique de Louvain, Institut de Recherche Expérimentale et Clinique, Neuromusculoskeletal lab, Brussels, Belgium.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'David', 'Affiliation': ""Ariel University, Departement of Physiotherapy, Ari'el, Israel.""}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Hall', 'Affiliation': 'Clinique Universitaire Saint-Luc, Service De Médecine Physique Et Réadaptation, Bruxelles, Belgium.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hidalgo', 'Affiliation': 'Université Catholique de Louvain, Institut de Recherche Expérimentale et Clinique, Neuromusculoskeletal lab, Brussels, Belgium.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2021.1889165']
415,33632110,Ventilatory Response to Hypercapnia as Experimental Model to Study Effects of Oxycodone on Respiratory Depression.,"BACKGROUND


Opioid analgesics used to treat pain can cause respiratory depression. However, this effect has not been extensively studied, and life-threatening, opioid-induced respiratory depression remains difficult to predict. We tested the ventilatory response to hypercapnia for evaluating the pharmacodynamic effect of a drug on respiratory depression.
METHODS


We conducted a randomized, placebo-controlled, double-blind, crossover study on 12 healthy adult males. Subjects received 2 treatments (placebo and immediate-release oxycodone 30 mg) separated by a 24-hour washout period. Subjects inhaled a mixture of 7% carbon dioxide, 21% oxygen, and 72% nitrogen for 5 minutes to assess respiratory depression. Minute ventilation, respiratory rate, tidal volume, flow rate, end-tidal CO2, and oxygen saturation were recorded continuously at pre-dose and 30, 60, 120, and 180 minutes post-dose. The primary endpoint was the effect on the ventilatory response to hypercapnia at 60 minutes post-dose, as assessed by the slope of the linear relationship between minute ventilation and end-tidal CO2.
RESULTS


At 60 minutes post-dose, subjects had a mean slope of 2.4 in the oxycodone crossover period, compared to 0.1 in the placebo period (mean difference, 2.3; 95% CI: 0.2 to 4.5; p = 0.035). Statistical significance was likewise achieved at the secondary time points (30, 120, and 180 minutes post-dose, p <0.05).
CONCLUSIONS


This model for testing ventilatory response to hypercapnia discriminated the effect of 30 mg of oxycodone  vs . placebo for up to 3 hours after a single dose. It may serve as a method to predict the relative effect of a drug on respiratory depression.",2022,"At 60 minutes post-dose, subjects had a mean slope of 2.4 in the oxycodone crossover period, compared to 0.1 in the placebo period (mean difference, 2.3; 95%CI: 0.2 to 4.5; p = 0.035).",['12 healthy adult males'],"['placebo', '2 treatments (placebo and immediate-release oxycodone 30 mg) separated by a 24-hour washout period', 'oxycodone vs. placebo', 'Oxycodone', 'mixture of 7% carbon dioxide, 21% oxygen, and 72% nitrogen']","['respiratory depression', 'Respiratory Depression', 'Minute ventilation, respiratory rate, tidal volume, flow rate, end-tidal CO2, and oxygen saturation', 'slope of the linear relationship between minute ventilation and end-tidal CO2', 'ventilatory response to hypercapnia']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C1127511', 'cui_str': 'Oxycodone 30 MG'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}]","[{'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}]",12.0,0.239376,"At 60 minutes post-dose, subjects had a mean slope of 2.4 in the oxycodone crossover period, compared to 0.1 in the placebo period (mean difference, 2.3; 95%CI: 0.2 to 4.5; p = 0.035).","[{'ForeName': 'Lynn R', 'Initials': 'LR', 'LastName': 'Webster', 'Affiliation': 'Early Development Services, PRA Health Sciences, Salt Lake City, Utah UT 84122 USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hansen', 'Affiliation': 'Early Development Services, PRA Health Sciences, Salt Lake City, Utah UT 84122 USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Stoddard', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Rynders', 'Affiliation': 'Early Development Services, PRA Health Sciences, Salt Lake City, Utah UT 84122 USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ostler', 'Affiliation': 'Early Development Services, PRA Health Sciences, Salt Lake City, Utah UT 84122 USA.'}, {'ForeName': 'Harley', 'Initials': 'H', 'LastName': 'Lennon', 'Affiliation': 'Early Development Services, PRA Health Sciences, Salt Lake City, Utah UT 84122 USA.'}]",Current reviews in clinical and experimental pharmacology,['10.2174/1574884716666210225083213']
416,33646730,Effects of Laughter Therapy on Life Satisfaction and Loneliness in Older Adults Living in Nursing Homes in Turkey: A Parallel Group Randomized Controlled Trial.,,2021,,['Older Adults Living in Nursing Homes in Turkey'],['Laughter Therapy'],['Life Satisfaction and Loneliness'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0949806', 'cui_str': 'Laughter Therapy'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}]",,0.184037,,[],Rehabilitation nursing : the official journal of the Association of Rehabilitation Nurses,['10.1097/RNJ.0000000000000321']
417,33644992,Discrepancy Between Multi-Biomarker Disease Activity and Clinical Disease Activity Scores in Patients With Persistently Active Rheumatoid Arthritis.,"OBJECTIVE


Responsive assessment of disease activity in patients with rheumatoid arthritis (RA) is necessary to evaluate therapeutic efficacy and guide treatment. We compared the utility of the multi-biomarker disease activity (MBDA) score in assessing RA disease activity with that of the Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) and the Clinical Disease Activity Index (CDAI) in a multicenter, randomized, placebo-controlled trial of repository corticotropin injection (RCI) in patients with persistently active RA.
METHODS


Patients received 80 U of RCI twice weekly during a 12-week open-label period; those who achieved low disease activity at week 12 were randomly assigned to receive either 80 U of RCI or placebo twice weekly during a 12-week double-blind period. Changes in disease activity (measured by DAS28-ESR, CDAI, and MBDA) and correlations between MBDA scores and both DAS28-ESR and CDAI scores were assessed.
RESULTS


Changes from baseline in DAS28-ESR and CDAI scores suggested that RCI therapy led to clinically meaningful improvements in disease activity, but improvements from baseline in MBDA scores were below the minimally important difference threshold. For the DAS28-ESR and CDAI, correlations with total MBDA and individual component scores were generally low (r≤0.3), occasionally moderate (r>0.3 but <0.5).
CONCLUSION


Our results suggest overall MBDA scores are not sufficiently responsive for assessing RA disease activity after RCI therapy. These findings are consistent with those seen with other RA drugs and, although they are from a clinical trial, suggest the MBDA should not be a preferred disease activity measure in clinical practice.",2021,"RESULTS


Changes from baseline in DAS28-ESR and CDAI scores suggested that RCI therapy led to clinically meaningful improvements in disease activity, but improvements from baseline in MBDA scores were below the minimally important difference threshold.","['patients with persistently active RA', 'Patients With Persistently Active Rheumatoid Arthritis', 'patients with rheumatoid arthritis (RA', 'Patients received 80 U of RCI twice weekly during a 12-week open-label period; those who achieved low disease activity at week 12']","['RCI or placebo', 'repository corticotropin injection (RCI', 'placebo']","['Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) and the Clinical Disease Activity Index (CDAI', 'DAS28-ESR, CDAI, and MBDA) and correlations between MBDA scores and both DAS28-ESR and CDAI scores', 'disease activity', 'total MBDA and individual component scores', 'overall MBDA scores', 'DAS28-ESR and CDAI scores', 'MBDA scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0473228,"RESULTS


Changes from baseline in DAS28-ESR and CDAI scores suggested that RCI therapy led to clinically meaningful improvements in disease activity, but improvements from baseline in MBDA scores were below the minimally important difference threshold.","[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas, United States.'}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, New Jersey, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, New Jersey, United States.'}, {'ForeName': 'Oscar G', 'Initials': 'OG', 'LastName': 'Segurado', 'Affiliation': 'SSI Strategy, San Jose, California, United States.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'David Geffen School of Medicine, Division of Rheumatology, University of California, Los Angeles, California, United States.'}]",Arthritis care & research,['10.1002/acr.24583']
418,33646286,Intermittent vs Continuous Pulse Oximetry in Hospitalized Infants With Stabilized Bronchiolitis: A Randomized Clinical Trial.,"Importance


There is low level of evidence and substantial practice variation regarding the use of intermittent or continuous monitoring in infants hospitalized with bronchiolitis.
Objective


To compare the effect of intermittent vs continuous pulse oximetry on clinical outcomes.
Design, Setting, and Participants


This multicenter, pragmatic randomized clinical trial included infants 4 weeks to 24 months of age who were hospitalized with bronchiolitis from November 1, 2016, to May 31, 2019, with or without supplemental oxygen after stabilization at community and children's hospitals in Ontario, Canada.
Interventions


Intermittent (every 4 hours, n = 114) or continuous (n = 115) pulse oximetry, using an oxygen saturation target of 90% or higher.
Main Outcomes and Measures


The primary outcome was length of hospital stay from randomization to discharge. Secondary outcomes included length of stay from inpatient unit admission to discharge and outcomes measured from randomization: medical interventions, safety (intensive care unit transfer and revisits), parent anxiety and workdays missed, and nursing satisfaction.
Results


Among 229 infants enrolled (median [IQR] age, 4.0 [2.2-8.5] months; 136 [59.4%] male; 101 [44.1%] from community hospital sites), the median length of hospital stay from randomization to discharge was 27.6 hours (interquartile range [IQR], 18.8-49.6 hours) in the intermittent group and 25.4 hours (IQR, 18.3-47.6 hours) in the continuous group (difference of medians, 2.2 hours; 95% CI, -1.9 to 6.3 hours; P = .17). No significant differences were observed between the intermittent and continuous groups in the median length of stay from inpatient unit admission to discharge: 49.1 (IQR, 37.2-87.0) hours vs 46.0 (IQR, 32.5-73.8) hours (P = .13) or in frequencies or durations of hospital interventions, such as oxygen supplementation initiation: 4 of 114 (3.5%) vs. 9 of 115 (7.8%) (P = .16) and median duration of oxygen supplementation: 20.6 (IQR, 7.6-46.1) hours vs. 21.4 (11.6-52.9) hours (P = .66). Similarly, there were no significant differences in frequencies of intensive care unit transfer: 1 of 114 (0.9%) vs 2 of 115 (2.7%) (P = .76); readmission to hospital: 3 of 114 (2.6%) in the intermittent group vs 4 of 115 (3.5%) in the continuous group (P > .99); parent anxiety: mean (SD) parent anxiety score, 2.9 (0.9) in the intermittent group vs 2.8 (0.9) in the continuous group (P = .40); or parent workdays missed: median workdays missed, 1.5 (IQR, 0.5-3.0) vs 1.5 (IQR, 0.5-2.5) (P = .36). Mean (SD) nursing satisfaction with monitoring was significantly greater in the intermittent group: 8.6 (1.7) vs 7.1 (2.8) of 10 workdays; the mean difference was 1.5 (95% CI, 0.9-2.2; P < .001).
Conclusions and Relevance


In this randomized clinical trial, among infants hospitalized with stabilized bronchiolitis with and without hypoxia and managed using an oxygen saturation target of 90% or higher, clinical outcomes, including length of hospital stay and safety, were similar with intermittent vs continuous pulse oximetry. Nursing satisfaction was greater with intermittent monitoring. Given that other important clinical practice considerations favor less intense monitoring, these findings support the standard use of intermittent pulse oximetry in stable infants hospitalized with bronchiolitis.
Trial Registration


ClinicalTrials.gov Identifier: NCT02947204.",2021,"No significant differences were observed between the intermittent and continuous groups in the median length of stay from inpatient unit admission to discharge: 49.1 (IQR, 37.2-87.0) hours vs 46.0 (IQR, 32.5-73.8) hours (P = .13) or in frequencies or durations of hospital interventions, such as oxygen supplementation initiation: 4 of 114 (3.5%) vs. 9 of 115 (7.8%) (P = .16) and median duration of oxygen supplementation: 20.6 (IQR, 7.6-46.1) hours vs. 21.4 (11.6-52.9) hours (P = .66).","[""infants 4 weeks to 24 months of age who were hospitalized with bronchiolitis from November 1, 2016, to May 31, 2019, with or without supplemental oxygen after stabilization at community and children's hospitals in Ontario, Canada"", 'stable infants hospitalized with bronchiolitis', 'With Stabilized Bronchiolitis', 'Hospitalized Infants', 'infants hospitalized with bronchiolitis', 'infants hospitalized with stabilized bronchiolitis with and without hypoxia and managed using an oxygen saturation target of 90% or higher, clinical outcomes, including length of hospital stay and safety, were similar with intermittent vs continuous pulse oximetry', '229 infants enrolled (median [IQR] age, 4.0 [2.2-8.5] months; 136 [59.4%] male; 101 [44.1%] from community hospital sites']","['intermittent vs continuous pulse oximetry', 'Intermittent vs Continuous Pulse Oximetry']","['length of hospital stay from randomization to discharge', 'Nursing satisfaction', 'median duration of oxygen supplementation', 'anxiety: mean (SD) parent anxiety score', 'median length of hospital stay', 'length of stay from inpatient unit admission to discharge and outcomes measured from randomization: medical interventions, safety (intensive care unit transfer and revisits), parent anxiety and workdays missed, and nursing satisfaction', 'frequencies of intensive care unit transfer', 'Mean (SD) nursing satisfaction with monitoring', 'median length of stay']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1960498', 'cui_str': 'Continuous pulse oximetry'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1960498', 'cui_str': 'Continuous pulse oximetry'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",229.0,0.25354,"No significant differences were observed between the intermittent and continuous groups in the median length of stay from inpatient unit admission to discharge: 49.1 (IQR, 37.2-87.0) hours vs 46.0 (IQR, 32.5-73.8) hours (P = .13) or in frequencies or durations of hospital interventions, such as oxygen supplementation initiation: 4 of 114 (3.5%) vs. 9 of 115 (7.8%) (P = .16) and median duration of oxygen supplementation: 20.6 (IQR, 7.6-46.1) hours vs. 21.4 (11.6-52.9) hours (P = .66).","[{'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Mahant', 'Affiliation': 'Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Wahi', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, McMaster University and McMaster Children's Hospital, Hamilton, Ontario, Canada.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bayliss', 'Affiliation': 'Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Giglia', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, McMaster University and McMaster Children's Hospital, Hamilton, Ontario, Canada.""}, {'ForeName': 'Ronik', 'Initials': 'R', 'LastName': 'Kanani', 'Affiliation': 'Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Pound', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada.""}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Sakran', 'Affiliation': 'Department of Pediatrics, Queens University, Kingston, Ontario, Canada.'}, {'ForeName': 'Natascha', 'Initials': 'N', 'LastName': 'Kozlowski', 'Affiliation': 'Department of Pediatrics, Lakeridge Health, Oshawa, Ontario, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Breen-Reid', 'Affiliation': 'Learning Institute, Hospital for Sick Children and Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Arafeh', 'Affiliation': 'Child Health Evaluative Sciences, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Myla E', 'Initials': 'ME', 'LastName': 'Moretti', 'Affiliation': 'Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Amisha', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.""}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Barrowman', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.""}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Willan', 'Affiliation': 'Ontario Child Health Support Unit, SickKids Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Schuh', 'Affiliation': 'Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Parkin', 'Affiliation': 'Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.6141']
419,33646267,Effect of a Multifaceted Clinical Pharmacist Intervention on Medication Safety After Hospitalization in Persons Prescribed High-risk Medications: A Randomized Clinical Trial.,"Importance


The National Action Plan for Adverse Drug Event (ADE) Prevention identified 3 high-priority, high-risk drug classes as targets for reducing the risk of drug-related injuries: anticoagulants, diabetes agents, and opioids.
Objective


To determine whether a multifaceted clinical pharmacist intervention improves medication safety for patients who are discharged from the hospital and prescribed medications within 1 or more of these high-risk drug classes.
Design, Setting, and Participants


This randomized clinical trial was conducted at a large multidisciplinary group practice in Massachusetts and included patients 50 years or older who were discharged from the hospital and prescribed at least 1 high-risk medication. Participants were enrolled into the trial from June 2016 through September 2018.
Interventions


The pharmacist-directed intervention included an in-home assessment by a clinical pharmacist, evidence-based educational resources, communication with the primary care team, and telephone follow-up. Participants in the control group were provided educational materials via mail.
Main Outcomes and Measures


The study assessed 2 outcomes over a 45-day posthospital discharge period: (1) adverse drug-related incidents and (2) a subset defined as clinically important medication errors, which included preventable or ameliorable ADEs and potential ADEs (ie, medication-related errors that may not yet have caused injury to a patient, but have the potential to cause future harm if not addressed). Clinically important medication errors were the primary study outcome.
Results


There were 361 participants (mean [SD] age, 68.7 [9.3] years; 177 women [49.0%]; 319 White [88.4%] and 8 Black individuals [2.2%]). Of these, 180 (49.9%) were randomly assigned to the intervention group and 181 (50.1%) to the control group. Among all participants, 100 (27.7%) experienced 1 or more adverse drug-related incidents, and 65 (18%) experienced 1 or more clinically important medication errors. There were 81 adverse drug-related incidents identified in the intervention group and 72 in the control group. There were 44 clinically important medication errors in the intervention group and 45 in the control group. The intervention did not significantly alter the per-patient rate of adverse drug-related incidents (unadjusted incidence rate ratio, 1.13; 95% CI, 0.83-1.56) or clinically important medication errors (unadjusted incidence rate ratio, 0.99; 95% CI, 0.65-1.49).
Conclusions and Relevance


In this randomized clinical trial, there was not an observed lower rate of adverse drug-related incidents or clinically important medication errors during the posthospitalization period that was associated with a clinical pharmacist intervention. However, there were study recruitment challenges and lower than expected numbers of events among the study population.
Trial Registration


ClinicalTrials.gov Identifier: NCT02781662.",2021,"In this randomized clinical trial, there was not an observed lower rate of adverse drug-related incidents or clinically important medication errors during the posthospitalization period that was associated with a clinical pharmacist intervention.","['large multidisciplinary group practice in Massachusetts and included patients 50 years or older who were discharged from the hospital and prescribed at least 1 high-risk medication', 'patients who are discharged from the hospital and prescribed medications within 1 or more of these high-risk drug classes', 'Persons Prescribed High-risk Medications', 'Participants were enrolled into the trial from June 2016 through September 2018', '361 participants (mean [SD] age, 68.7 [9.3] years; 177 women [49.0%]; 319 White [88.4%] and 8 Black individuals [2.2']","['multifaceted clinical pharmacist intervention', 'pharmacist-directed intervention included an in-home assessment by a clinical pharmacist, evidence-based educational resources, communication with the primary care team, and telephone follow-up', 'Multifaceted Clinical Pharmacist Intervention', 'educational materials via mail']","['45-day posthospital discharge period: (1) adverse drug-related incidents and (2) a subset defined as clinically important medication errors, which included preventable or ameliorable ADEs and potential ADEs (ie, medication-related errors', 'per-patient rate of adverse drug-related incidents', 'Medication Safety', 'medication safety']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4517629', 'cui_str': '2.2'}]","[{'cui': 'C1449564', 'cui_str': 'Clinical pharmacist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0579118', 'cui_str': 'Home assessment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0024492', 'cui_str': 'Mail'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1547273', 'cui_str': 'Preventable'}, {'cui': 'C0057163', 'cui_str': 'DAV regimen'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.185459,"In this randomized clinical trial, there was not an observed lower rate of adverse drug-related incidents or clinically important medication errors during the posthospitalization period that was associated with a clinical pharmacist intervention.","[{'ForeName': 'Jerry H', 'Initials': 'JH', 'LastName': 'Gurwitz', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Garber', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mazor', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester.'}, {'ForeName': 'Joann', 'Initials': 'J', 'LastName': 'Wagner', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Cutrona', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester.'}, {'ForeName': 'Sonal', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester.'}, {'ForeName': 'Abir O', 'Initials': 'AO', 'LastName': 'Kanaan', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Crawford', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Anzuoni', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Konola', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester.'}, {'ForeName': 'Terry S', 'Initials': 'TS', 'LastName': 'Field', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.9285']
420,33647972,A prospective phase II randomized trial of proton radiotherapy vs intensity-modulated radiotherapy for patients with newly diagnosed glioblastoma.,"BACKGROUND


To determine if proton radiotherapy (PT), compared to intensity-modulated radiotherapy (IMRT), delayed time to cognitive failure in patients with newly diagnosed glioblastoma (GBM).
METHODS


Eligible patients were randomized unblinded to PT vs IMRT. The primary endpoint was time to cognitive failure. Secondary endpoints included overall survival (OS), intracranial progression-free survival (PFS), toxicity, and patient-reported outcomes (PROs).
RESULTS


A total of 90 patients were enrolled and 67 were evaluable with median follow-up of 48.7 months (range 7.1-66.7). There was no significant difference in time to cognitive failure between treatment arms (HR, 0.88; 95% CI, 0.45-1.75; P = .74). PT was associated with a lower rate of fatigue (24% vs 58%, P = .05), but otherwise, there were no significant differences in PROs at 6 months. There was no difference in PFS (HR, 0.74; 95% CI, 0.44-1.23; P = .24) or OS (HR, 0.86; 95% CI, 0.49-1.50; P = .60). However, PT significantly reduced the radiation dose for nearly all structures analyzed. The average number of grade 2 or higher toxicities was significantly higher in patients who received IMRT (mean 1.15, range 0-6) compared to PT (mean 0.35, range 0-3; P = .02).
CONCLUSIONS


In this signal-seeking phase II trial, PT was not associated with a delay in time to cognitive failure but did reduce toxicity and patient-reported fatigue. Larger randomized trials are needed to determine the potential of PT such as dose escalation for GBM and cognitive preservation in patients with lower-grade gliomas with a longer survival time.",2021,"PT was associated with a lower rate of fatigue (24% vs. 58%, P=0.05), but otherwise there were no significant differences in patient-reported outcomes at 6 months.","['Patients with Newly Diagnosed Glioblastoma', 'Eligible patients', 'patients with lower grade gliomas with a longer survival time', 'patients with newly diagnosed glioblastoma', 'A total of 90 patients were enrolled and 67 were evaluable with median follow-up of 48.7 months ']","['Proton Radiotherapy vs. Intensity Modulated Radiotherapy', 'intensity modulated radiotherapy (IMRT', 'PT vs. IMRT', 'proton radiotherapy (PT', 'IMRT']","['PFS', 'average number of grade 2 or higher toxicities', 'rate of fatigue', 'time to cognitive failure', 'overall survival (OS), intracranial progression-free survival (PFS), toxicity, and patient-reported outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C1997217', 'cui_str': 'Low grade glioma'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",90.0,0.140947,"PT was associated with a lower rate of fatigue (24% vs. 58%, P=0.05), but otherwise there were no significant differences in patient-reported outcomes at 6 months.","[{'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Brown', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Chung', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McAvoy', 'Affiliation': 'Department of Radiation Oncology, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Grosshans', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Al Feghali', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McGovern', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Mary-Fran', 'Initials': 'MF', 'LastName': 'McAleer', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Amol J', 'Initials': 'AJ', 'LastName': 'Ghia', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Sulman', 'Affiliation': 'Department of Radiation Oncology, NYU Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Penas-Prado', 'Affiliation': 'Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'de Groot', 'Affiliation': 'Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Amy B', 'Initials': 'AB', 'LastName': 'Heimberger', 'Affiliation': 'Department of Neurosurgery, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Terri S', 'Initials': 'TS', 'LastName': 'Armstrong', 'Affiliation': 'Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Gilbert', 'Affiliation': 'Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Guha-Thakurta', 'Affiliation': 'Department of Neuroradiology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Wefel', 'Affiliation': 'Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",Neuro-oncology,['10.1093/neuonc/noab040']
421,33648819,Understanding intracortical excitability in phantom limb pain: A multivariate analysis from a multicenter randomized clinical trial.,"OBJECTIVES


To explore associations of intracortical excitability with clinical characteristics in a large sample of subjects with phantom limb pain (PLP).
METHODS


Ancillary study using baseline and longitudinal data from a large multicenter randomized trial that investigated the effects of non-invasive brain stimulation combined with sensorimotor training on PLP. Multivariate regression modeling analyses were used to investigate the association of intracortical excitability, measured by percentages of intracortical inhibition (ICI) and facilitation (ICF) with clinical variables.
RESULTS


Ninety-eight subjects were included. Phantom sensation of itching was positively associated with ICI changes and at baseline in the affected hemisphere (contralateral to PLP). However, in the non-affected hemisphere (ipsilateral to PLP), the phantom sensation of warmth and PLP intensity were negatively associated with ICI (both models). For the ICF, PLP intensity (baseline model only) and age (longitudinal model) were negatively associated, while time since amputation and amputation level (both for longitudinal model only) were positively associated in the affected hemisphere. Additionally, use of antidepressants led to lower ICF in the non-affected hemisphere for the baseline model while higher amputation level also led to less changes in the ICF.
CONCLUSION


Results revealed clear associations of clinical variables and cortical excitability in a large chronic pain sample. ICI and ICF changes appear not to be mainly explained by PLP intensity. Instead, other variables associated with duration of neuroplasticity changes (such as age and duration of amputation) and compensatory mechanisms (such as itching and phantom limb sensation) seem to be more important in explaining these variables.",2021,Phantom sensation of itching was positively associated with ICI changes and at baseline in the affected hemisphere (contralateral to PLP).,"['Ninety-eight subjects were included', 'subjects with phantom limb pain (PLP', 'phantom limb pain']",['non-invasive brain stimulation combined with sensorimotor training'],"['phantom sensation of warmth and PLP intensity', 'Phantom sensation of itching', 'time since amputation and amputation level', 'intracortical inhibition (ICI) and facilitation (ICF']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031315', 'cui_str': 'Phantom limb'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0031315', 'cui_str': 'Phantom limb'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}]",98.0,0.120529,Phantom sensation of itching was positively associated with ICI changes and at baseline in the affected hemisphere (contralateral to PLP).,"[{'ForeName': 'Paulo E P', 'Initials': 'PEP', 'LastName': 'Teixeira', 'Affiliation': 'Neuromodulation and Clinical Research Learning Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Charlestown, MA, USA; Harvard Medical School, Boston, MA, USA; MGH Institute of Health Professions, Boston, MA, USA; Instituto Wilson Mello, Campinas, SP, Brazil. Electronic address: pteixeira2@mgh.harvard.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Pacheco-Barrios', 'Affiliation': 'Neuromodulation and Clinical Research Learning Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Charlestown, MA, USA; Harvard Medical School, Boston, MA, USA; Universidad San Ignacio de Loyola, Vicerrectorado de Investigación, Unidad de Investigación para la Generación y Síntesis de Evidencias en Salud, Lima, Peru.'}, {'ForeName': 'Muhammed Enes', 'Initials': 'ME', 'LastName': 'Gunduz', 'Affiliation': 'Neuromodulation and Clinical Research Learning Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Charlestown, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Anna Carolyna', 'Initials': 'AC', 'LastName': 'Gianlorenço', 'Affiliation': 'Neuromodulation and Clinical Research Learning Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Charlestown, MA, USA; Harvard Medical School, Boston, MA, USA; Laboratory of neuroscience, Department of Physical Therapy, Federal University of Sao Carlos, SP, Brazil.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Castelo-Branco', 'Affiliation': 'Neuromodulation and Clinical Research Learning Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Charlestown, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Neuromodulation and Clinical Research Learning Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Charlestown, MA, USA; Harvard Medical School, Boston, MA, USA; Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}]",Neurophysiologie clinique = Clinical neurophysiology,['10.1016/j.neucli.2020.12.006']
422,33654204,Midostaurin reduces relapse in FLT3-mutant acute myeloid leukemia: the Alliance CALGB 10603/RATIFY trial.,"The prospective randomized, placebo-controlled CALGB 10603/RATIFY trial (Alliance) demonstrated a statistically significant overall survival benefit from the addition of midostaurin to standard frontline chemotherapy in a genotypically-defined subgroup of 717 patients with FLT3-mutant acute myeloid leukemia (AML). The risk of death was reduced by 22% on the midostaurin-containing arm. In this post hoc analysis, we analyzed the cumulative incidence of relapse (CIR) on this study and also evaluated the impact of 12 4-week cycles of maintenance therapy. CIR analyses treated relapses and AML deaths as events, deaths from other causes as competing risks, and survivors in remission were censored. CIR was improved on the midostaurin arm (HR = 0.71 (95% CI, 0.54-0.93); p = 0.01), both overall and within European LeukemiaNet 2017 risk classification subsets when post-transplant events were considered in the analysis as events. However, when transplantation was considered as a competing risk, there was overall no significant difference between the risks of relapse on the two randomized arms. Patients still in remission after consolidation with high-dose cytarabine entered the maintenance phase, continuing with either midostaurin or placebo. Analyses were inconclusive in quantifying the impact of the maintenance phase on the overall outcome. In summary, midostaurin reduces the CIR.",2021,"CIR was improved on the midostaurin arm (HR = 0.71 (95% CI, 0.54-0.93); p = 0.01), both overall and within European LeukemiaNet 2017 risk classification subsets when post-transplant events were considered in the analysis as events.","['FLT3-mutant acute myeloid leukemia', '717 patients with FLT3-mutant acute myeloid leukemia (AML']","['cytarabine', 'midostaurin to standard frontline chemotherapy', 'placebo', 'midostaurin or placebo', 'Midostaurin']","['risks of relapse', 'overall survival benefit', 'CIR', 'cumulative incidence of relapse (CIR', 'risk of death']","[{'cui': 'C0251006', 'cui_str': 'FLT3 protein, human'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0526371', 'cui_str': 'midostaurin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",717.0,0.245335,"CIR was improved on the midostaurin arm (HR = 0.71 (95% CI, 0.54-0.93); p = 0.01), both overall and within European LeukemiaNet 2017 risk classification subsets when post-transplant events were considered in the analysis as events.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': 'Department of Medicine and Comprehensive Cancer Center, University of Chicago, Chicago, IL, USA. rlarson@medicine.bsd.uchicgo.edu.'}, {'ForeName': 'Sumithra J', 'Initials': 'SJ', 'LastName': 'Mandrekar', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Lucas J', 'Initials': 'LJ', 'LastName': 'Huebner', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ben L', 'Initials': 'BL', 'LastName': 'Sanford', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Laumann', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Geyer', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Clara D', 'Initials': 'CD', 'LastName': 'Bloomfield', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiede', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus der TU Dresden, Dresden, Germany.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Prior', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Konstanze', 'Initials': 'K', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Marcucci', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Voso', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Klisovic', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Ilene', 'Initials': 'I', 'LastName': 'Galinsky', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Wei', 'Affiliation': 'Department of Clinical Haematology, The Alfred Hospital and Monash University, Melbourne, Australia.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sierra', 'Affiliation': 'Hematology Department, Hospital de la Santa Creu i Sant Pau, IIB Sant Pau and Jose Carreras Leukemia Research Institute, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Sanz', 'Affiliation': 'Department of Hematology, Hospital Universitario y Politécnico La Fe and Department of Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Brandwein', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'de Witte', 'Affiliation': 'Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Dietger', 'Initials': 'D', 'LastName': 'Niederwieser', 'Affiliation': 'Department of Hematology and Oncology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Frederick R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Bruno C', 'Initials': 'BC', 'LastName': 'Medeiros', 'Affiliation': 'Division of Hematology, Stanford Comprehensive Cancer Center, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': 'Leukemia Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Krauter', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Serve', 'Affiliation': 'Department of Medicine II, Hematology/Oncology, Goethe University Hospital Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ehninger', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus der TU Dresden, Dresden, Germany.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Amadori', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Insa', 'Initials': 'I', 'LastName': 'Gathmann', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Stone', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}]",Leukemia,['10.1038/s41375-021-01179-4']
423,33657420,Tube Versus Trabeculectomy IRIS Ⓡ  Registry 1-Year Composite Outcome Analysis with Comparisons to the Randomized Controlled Trial.,"PURPOSE


This study compared 1-year results for the composite treatment outcome from the Tube Versus Trabeculectomy (TVT) randomized controlled trial (RCT) to those from an IRIS Ⓡ  (Intelligent Research In Sight) Registry cohort of analogous eyes.
DESIGN


Retrospective clinical study with comparison to an RCT.
METHODS


Subjects' eyes in the IRIS Registry received either a glaucoma drainage implant (tube) or underwent trabeculectomy after a previous trabeculectomy and/or cataract extraction and had data for 1-year follow-up analyses.
OUTCOME


Eyes were classified as failing if they had hypotony (intraocular pressure (IOP) ≤5 mm Hg) or inadequate IOP control (IOP >21 mm Hg or not reduced at least 20% below baseline) on 2 consecutive follow-up visits after 3 months, a reoperation for glaucoma, or no light perception vision and as successful otherwise. Failure risk was compared by treatment, demographic, and clinical variables and was compared to analogous failure risks from the TVT RCT.
RESULTS


The TVT IRIS Registry cohort included 419 eyes, 236 tube eyes (56.3%) and 183 trabeculectomy eyes (43.7%). In this cohort, there was no significant failure risk difference (12.3% for tube eyes and 16.4% for trabeculectomy eyes, P = 0.231). Comparing the studies, there was a significantly greater risk of failure in the TVT IRIS Registry tube eyes than in the TVT RCT tube eyes (3.8%; P <.001). Reasons for treatment failure included reoperations for glaucoma (none in the TVT RCT at 1 year).
CONCLUSIONS


Our results were different from those in the TVT RCT. Possible reasons include non-Baerveldt tubes, greater severity among tube eyes, and practice patterns that reflect real-world data, which are different than those in RCTs.",2021,"In this cohort, there was no significant failure risk difference (12.3% for tube eyes and 16.4% for trabeculectomy eyes, P=0.231).","['Subjects: Eyes in the IRIS Registry receiving either a', '419 eyes, 236 tube eyes (56.3%) and 183 trabeculectomy eyes (43.7']","['TVT RCT', 'Tube vs Trab IRIS Registry', 'Tube Versus Trabeculectomy (TVT', 'glaucoma drainage implant (tube) or trabeculectomy after a previous trabeculectomy and/or cataract extraction with data for one-year follow-up analyses']","['Failure risk', 'risk of failure', 'reoperation for glaucoma, or no light perception vision', 'failure risk difference', 'hypotony (intraocular pressure (IOP)≤5 mmHg) or inadequate IOP control (IOP>21 mmHg']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0022077', 'cui_str': 'Iris structure'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0328667', 'cui_str': 'Stylephorus chordatus'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}]","[{'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022077', 'cui_str': 'Iris structure'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0181041', 'cui_str': 'Glaucoma drainage device'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0442774', 'cui_str': 'Visual acuity, no light perception'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",419.0,0.0580518,"In this cohort, there was no significant failure risk difference (12.3% for tube eyes and 16.4% for trabeculectomy eyes, P=0.231).","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Vanner', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA. Electronic address: EAV45@med.miami.edu.'}, {'ForeName': 'Catherine Q', 'Initials': 'CQ', 'LastName': 'Sun', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA; University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'McSoley', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA; University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Patrice J', 'Initials': 'PJ', 'LastName': 'Persad', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Feuer', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Lum', 'Affiliation': 'American Academy of Ophthalmology, San Francisco, California.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Kelly', 'Affiliation': 'American Academy of Ophthalmology, San Francisco, California.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Parrish', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA.'}, {'ForeName': 'Ta C', 'Initials': 'TC', 'LastName': 'Chang', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Gedde', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2021.02.023']
424,33657083,Mindfulness-Based Stress Reduction Buffers Glucocorticoid Resistance Among Older Adults: A Randomized Controlled Trial.,"OBJECTIVE


Mindfulness interventions have been effective for improving a range of health outcomes; however, pathways underlying these effects remain unclear. Inflammatory processes may play a role, possibly through increased resistance of immune cells to the anti-inflammatory effects of glucocorticoids (i.e., glucocorticoid resistance, or GCR). Here, we conducted an initial examination of whether mindfulness training mitigates GCR among lonely older adults.
METHODS


Lonely older adults (65-85 years; n = 190) were randomly assigned to an 8-week Mindfulness-Based Stress Reduction (MBSR) or a matched Health Enhancement Program (HEP). Whole blood drawn before and after the intervention and at 3-month follow-up was incubated with endotoxin and varying concentrations of dexamethasone, and interleukin-6 production was assessed using enzyme-linked immunosorbent assay. GCR was assessed as the concentration of dexamethasone required to decrease the stimulated interleukin-6 response by 50% (half maximal inhibitory concentration), with higher concentrations indicating greater GCR. Mixed-effects linear models tested time (pre, post, follow-up) by condition (MBSR versus HEP) effects.
RESULTS


There was no overall time by condition effect on GCR across all time points. However, a significant time by condition effect was observed from preintervention to postintervention (d = 0.29), such that MBSR buffered increases in GCR observed in the HEP group. Although MBSR showed small, nonsignificant reductions in GCR from preintervention to 3-month follow-up, group differences were not maintained at the 3-month follow-up (d = 0.10).
CONCLUSIONS


Results suggest that MBSR may protect against declines in the sensitivity of immune cells to the anti-inflammatory effects of glucocorticoids among at-risk lonely older adults and show value in studying this biological mechanism in future trials.Trial Registration: Clinical Trials identifier NCT02888600.",2021,"Although MBSR showed small, nonsignificant reductions in GCR from pre-intervention to 3-month follow-up, group differences were not maintained at the 3-month follow-up (d=.10).
","['N=190', 'older adults', 'Lonely older adults (65-85 years', 'lonely older adults']","['MBSR', 'Mindfulness-Based Stress Reduction', 'mindfulness training mitigates glucocorticoid resistance (GCR', '8-week Mindfulness-Based Stress Reduction (MBSR) or a matched Health Enhancement Program (HEP']","['stimulated IL-6 response', 'GCR']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1841972', 'cui_str': 'Glucocorticoid Receptor Deficiency'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1841972', 'cui_str': 'Glucocorticoid Receptor Deficiency'}]",190.0,0.0613487,"Although MBSR showed small, nonsignificant reductions in GCR from pre-intervention to 3-month follow-up, group differences were not maintained at the 3-month follow-up (d=.10).
","[{'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Lindsay', 'Affiliation': 'From the University of Pittsburgh (Lindsay, Stern, Greco, Walsh, Wright, Marsland); Carnegie Mellon University (Creswell, Dutcher, Lipitz), Pittsburgh, Pennsylvania; and Virginia Commonwealth University (Brown), Richmond, Virginia.'}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Creswell', 'Affiliation': ''}, {'ForeName': 'Harrison J', 'Initials': 'HJ', 'LastName': 'Stern', 'Affiliation': ''}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Greco', 'Affiliation': ''}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Dutcher', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lipitz', 'Affiliation': ''}, {'ForeName': 'Catherine P', 'Initials': 'CP', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Aidan G C', 'Initials': 'AGC', 'LastName': 'Wright', 'Affiliation': ''}, {'ForeName': 'Kirk Warren', 'Initials': 'KW', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Marsland', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000928']
425,33636517,Predictors of Depressive Symptoms and Post Traumatic Stress Disorder Among Women Engaged in Commercial Sex Work in Southern Uganda.,"This study examined the factors associated with depressive symptoms and post traumatic depressive disorder (PTSD) among economically vulnerable women engaged in commercial sex work (WESW) in southern Uganda. Baseline data from a longitudinal cluster randomized study involving 542 self-identified WESW (18-55 years), recruited from 19 HIV hotspots were analyzed. Hierarchical linear regression modelling was utilized to estimate individual, family-level and economic-level predictors of depressive symptoms and PTSD. Family cohesion, sex work stigma, HIV status, financial distress, household assets, number of children and number of household income earners, were associated with PTSD. Similarly, family cohesion, number of people in the household, HIV status, sex work stigma, financial distress, and household assets, were associated with depressive symptoms. Women engaged in commercial sex work are at a higher risk of HIV and poor mental health outcomes. Sex work stigma and financial distress elevate levels of depressive symptoms and PTSD, over and above an individual's HIV status. Family and economic-level factors have the potential to mitigate the risk of poor mental health outcomes. As such, integrating stigma reduction and economic strengthening components in the programming targeting WESW-a key population, may be critical to address their mental health outcomes.",2021,"Family cohesion, sex work stigma, HIV status, financial distress, household assets, number of children and number of household income earners, were associated with PTSD.","['542 self-identified WESW (18-55 years), recruited from 19 HIV hotspots were analyzed', 'depressive symptoms and post traumatic depressive disorder (PTSD) among economically vulnerable women engaged in commercial sex work (WESW) in southern Uganda', 'Women', 'Engaged in Commercial Sex Work in Southern Uganda']",[],"['family cohesion, number of people in the household, HIV status, sex work stigma, financial distress', 'Family cohesion, sex work stigma, HIV status, financial distress, household assets, number of children and number of household income earners']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0033595', 'cui_str': 'Works as prostitute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]",[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0033595', 'cui_str': 'Works as prostitute'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0557163', 'cui_str': 'Household income'}]",542.0,0.0321672,"Family cohesion, sex work stigma, HIV status, financial distress, household assets, number of children and number of household income earners, were associated with PTSD.","[{'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: nabunyap@wustl.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: byansiw@wustl.edu.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: damulirac@wustl.edu.'}, {'ForeName': 'Ozge Sensoy', 'Initials': 'OS', 'LastName': 'Bahar', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: ozge.sensoybahar@wustl.edu.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Jennings Mayo-Wilson', 'Affiliation': 'Indiana University School of Public Health, Department of Applied Health Science, 1025 E. 7(TH) Street, Bloomington, IN 47405, USA. Electronic address: ljmayowi@iu.edu.'}, {'ForeName': 'Yesim', 'Initials': 'Y', 'LastName': 'Tozan', 'Affiliation': 'New York University College of Global Public Health, 14 East 4(th) street, 3(rd) floor. New York, NY 10003, USA. Electronic address: yt23@nyu.edu.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kiyingi', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: j.kiyingi@wustl.edu.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Nabayinda', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: josepn84@gmail.com.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Braithwaite', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: rachel.brathwaite@wustl.edu.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Witte', 'Affiliation': 'Columbia University School of Social Work1255 Amsterdam Avenue, New York, NY 10027, USA. Electronic address: ssw12@columbia.edu.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Washington University in St. Louis Brown School, International Center for Child Health and Development (ICHAD), 1 Brookings Drive, St. Louis, MO 63130, USA. Electronic address: fms1@wustl.edu.'}]",Psychiatry research,['10.1016/j.psychres.2021.113817']
426,33656374,Liposuction of Breast Cancer-Related Arm Lymphedema Reduces Fat and Muscle Hypertrophy.,"Background:  Adipose tissue deposition is a known consequence of lymphedema. A previous study showed that the affected arm in patients with nonpitting breast cancer-related lymphedema (BCRL) had a mean excess volume of 73% fat and 47% muscle. This condition impairs combined physiotherapy as well as more advanced microsurgical methods. Liposuction is, therefore, a way of improving the effects of treatment. This study aims to evaluate the tissue changes in lymphedematous arms after liposuction and controlled compression therapy (CCT) in patients with nonpitting BCRL.  Methods and Results:  Eighteen women with an age of 61 years and a duration of arm lymphedema (BCRL) of 9 years were treated with liposuction and CCT. Tissue composition of fat, lean (muscle), and bone mineral was analyzed through dual energy X-ray absorptiometry (DXA) before, and at 3 and 12 months after surgery. Excess volumes were also measured with plethysmography. The median DXA preoperative excess volume was 1425 mL (704 mL fat volume, 651 mL lean volume). The DXA excess volume at 3 months after surgery was 193 mL (-196 mL fat volume, 362 mL lean volume). At 12 months after surgery, the median excess DXA volume was 2 mL (-269 mL fat volume, 338 mL lean volume). From before surgery to 3 months after surgery, the median DXA excess volume reduced by 85% ( p  < 0.001) (fat volume reduction 128% ( p  < 0.001), lean volume reduction 37% ( p  = 0.016)). From before surgery to 12 months after surgery, it reduced by 100% ( p  < 0.001) (fat volume reduction 139% [ p  < 0.001], lean volume reduction 54% [ p  = 0.0013]).  Conclusions:  Liposuction and CCT effectively remove the excess fat in patients with nonpitting BCRL, and a total reduction of excess arm volume is achievable. A postoperative decrease in excess muscle volume is also seen, probably due to the reduced weight of the arm postoperatively.",2022,"From before surgery to 3 months after surgery, the median DXA excess volume reduced by 85% ( p  < 0.001) (fat volume reduction 128% ( p  < 0.001), lean volume reduction 37% ( p  = 0.016)).","['patients with nonpitting breast cancer-related lymphedema (BCRL', 'Eighteen women with an age of 61 years and a duration of arm lymphedema (BCRL) of 9 years were treated with', 'patients with nonpitting BCRL']","['mL', 'liposuction and CCT', 'liposuction and controlled compression therapy (CCT']","['lean volume reduction', 'median DXA preoperative excess volume', 'Tissue composition of fat, lean (muscle), and bone mineral', 'median excess DXA volume', 'median DXA excess volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0038640', 'cui_str': 'Liposuction of subcutaneous tissue'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}]",18.0,0.0506081,"From before surgery to 3 months after surgery, the median DXA excess volume reduced by 85% ( p  < 0.001) (fat volume reduction 128% ( p  < 0.001), lean volume reduction 37% ( p  = 0.016)).","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Karlsson', 'Affiliation': 'Department of Clinical Sciences, Lund University, Malmö, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Karlsson', 'Affiliation': 'Department of Clinical Sciences, Lund University, Malmö, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ohlin', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Olsson', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Brorson', 'Affiliation': 'Department of Clinical Sciences, Lund University, Malmö, Sweden.'}]",Lymphatic research and biology,['10.1089/lrb.2020.0120']
427,33655299,Transforming clinical research by involving and empowering patients- the RATE-AF randomized trial.,,2021,,[],[],[],[],[],[],,0.0434221,,"[{'ForeName': 'Karina V', 'Initials': 'KV', 'LastName': 'Bunting', 'Affiliation': 'Cardiac Physiologist & Postdoctoral Fellow, University of Birmingham & University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Stanbury', 'Affiliation': 'Lead for the Patient & Public Involvement Team, RATE-AF trial.'}, {'ForeName': 'Otilia', 'Initials': 'O', 'LastName': 'Tica', 'Affiliation': 'Cardiologist & Postdoctoral Fellow, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Dipak', 'Initials': 'D', 'LastName': 'Kotecha', 'Affiliation': 'Professor of Cardiology, Institute of Cardiovascular Sciences, University of Birmingham & University Hospitals Birmingham NHS Foundation Trust, Vincent Drive, Birmingham B15 2TT, UK.'}]",European heart journal,['10.1093/eurheartj/ehab098']
428,33655794,Integrated Diabetes Self-Management Program Using Smartphone Application: A Randomized Controlled Trial.,"This study identified the effects of an integrated diabetes self-management program using smartphone application (app), based on the Information-Motivation-Behavioral skills (IMB) model. A randomized comparison, using a pre-and post-test design, was conducted with 32 participants in the experimental group and 36 in the control group. The integrated diabetes self-management program consisted of face-to-face educational sessions, a diabetes self-management smartphone app, and phone counseling. In the experimental group, diabetes self-management knowledge (Z=-2.70,  p =.007), social motivation (Z=-1.97,  p =.048), and behavior (t=3.22,  p =.002) improved, with their hemoglobin A1c (Z=-4.83,  p <.001) decreasing compared to the control group. At the post-test, the experimental group's fasting blood sugar level (t=2.79,  p =.009), total calorie intake (t=3.94,  p =.001), carbohydrate intake (t=5.69,  p< .001), and fat intake (t=2.54,  p =.021) decreased compared to the pre-test. An integrated diabetes self-management program using smartphone app, based on the IMB model, should be utilized as a nursing intervention.",2022,"In the experimental group, diabetes self-management knowledge (Z=-2.70,  p =.007), social motivation (Z=-1.97,  p =.048), and behavior (t=3.22,  p =.002) improved, with their hemoglobin A1c (Z=-4.83,  p <.001) decreasing compared to the control group.",['32 participants in the experimental group and 36 in the control group'],"['integrated diabetes self-management program using smartphone application (app', 'Smartphone Application', 'integrated diabetes self-management program consisted of face-to-face educational sessions, a diabetes self-management smartphone app, and phone counseling']","['total calorie intake', 'carbohydrate intake', 'hemoglobin A1c', 'social motivation', 'diabetes self-management knowledge', 'fat intake', 'fasting blood sugar level']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",,0.0100694,"In the experimental group, diabetes self-management knowledge (Z=-2.70,  p =.007), social motivation (Z=-1.97,  p =.048), and behavior (t=3.22,  p =.002) improved, with their hemoglobin A1c (Z=-4.83,  p <.001) decreasing compared to the control group.","[{'ForeName': 'Yeojin', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Pusan National University Hospital, Busan, South Korea.'}, {'ForeName': 'Hyejin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Pusan National University, Yangsan, South Korea.'}, {'ForeName': 'Ji Min', 'Initials': 'JM', 'LastName': 'Seo', 'Affiliation': 'College of Nursing, Pusan National University, Yangsan, South Korea.'}]",Western journal of nursing research,['10.1177/0193945921994912']
429,33656561,Effect of Incentives for Alcohol Abstinence in Partnership With 3 American Indian and Alaska Native Communities: A Randomized Clinical Trial.,"Importance


Many American Indian and Alaska Native communities are disproportionately affected by problems with alcohol use and seek culturally appropriate and effective interventions for individuals with alcohol use disorders.
Objective


To determine whether a culturally tailored contingency management intervention, in which incentives were offered for biologically verified alcohol abstinence, resulted in increased abstinence among American Indian and Alaska Native adults. This study hypothesized that adults assigned to receive a contingency management intervention would have higher levels of alcohol abstinence than those assigned to the control condition.
Design, Setting, and Participants


This multisite randomized clinical trial, the Helping Our Native Ongoing Recovery (HONOR) study, included a 1-month observation period before randomization and a 3-month intervention period. The study was conducted at 3 American Indian and Alaska Native health care organizations located in Alaska, the Pacific Northwest, and the Northern Plains from October 10, 2014, to September 2, 2019. Recruitment occurred between October 10, 2014, and February 20, 2019. Eligible participants were American Indian or Alaska Native adults who had 1 or more days of high alcohol-use episodes within the last 30 days and a current diagnosis of alcohol dependence. Data were analyzed from February 1 to April 29, 2020.
Interventions


Participants received treatment as usual and were randomized to either the contingency management group, in which individuals received 12 weeks of incentives for submitting a urine sample indicating alcohol abstinence, or the control group, in which individuals received 12 weeks of incentives for submitting a urine sample without the requirement of alcohol abstinence. Regression models fit with generalized estimating equations were used to assess differences in abstinence during the intervention period.
Main Outcomes and Measures


Alcohol-negative ethyl glucuronide (EtG) urine test result (defined as EtG<150 ng/mL).
Results


Among 1003 adults screened for eligibility, 400 individuals met the initial criteria. Of those, 158 individuals (39.5%; mean [SD] age, 42.1 [11.4] years; 83 men [52.5%]) met the criteria for randomization, which required submission of 4 or more urine samples and 1 alcohol-positive urine test result during the observation period before randomization. A total of 75 participants (47.5%) were randomized to the contingency management group, and 83 participants (52.5%) were randomized to the control group. At 16 weeks, the number who submitted an alcohol-negative urine sample was 19 (59.4%) in the intervention group vs 18 (38.3%) in the control group. Participants randomized to the contingency management group had a higher likelihood of submitting an alcohol-negative urine sample (averaged over time) compared with those randomized to the control group (odds ratio, 1.70; 95% CI, 1.05-2.76; P = .03).
Conclusions and Relevance


The study's findings indicate that contingency management may be an effective strategy for increasing alcohol abstinence and a tool that can be used by American Indian and Alaska Native communities for the treatment of individuals with alcohol use disorders.
Trial Registration


ClinicalTrials.gov Identifier: NCT02174315.",2021,"Participants randomized to the contingency management group had a higher likelihood of submitting an alcohol-negative urine sample (averaged over time) compared with those randomized to the control group (odds ratio, 1.70; 95% CI, 1.05-2.76; P = .03).
","['1003 adults screened for eligibility, 400 individuals met the initial criteria', 'Partnership With 3 American Indian and Alaska Native Communities', 'A total of 75 participants (47.5%) were randomized to the contingency management group, and 83 participants (52.5', 'individuals with alcohol use disorders', '158 individuals (39.5%; mean [SD] age, 42.1 [11.4] years; 83 men [52.5%]) met the criteria for randomization, which required submission of 4 or more urine samples and 1 alcohol-positive urine test result during the observation period before randomization', '3 American Indian and Alaska Native health care organizations located in Alaska, the Pacific Northwest, and the Northern Plains from October 10, 2014, to September 2, 2019', 'American Indian and Alaska Native adults', 'Eligible participants were American Indian or Alaska Native adults who had 1 or more days of high alcohol-use episodes within the last 30 days and a current diagnosis of alcohol dependence']","['contingency management group, in which individuals received 12 weeks of incentives for submitting a urine sample indicating alcohol abstinence, or the control group, in which individuals received 12 weeks of incentives for submitting a urine sample without the requirement of alcohol abstinence', 'contingency management intervention', 'culturally tailored contingency management intervention']","['alcohol abstinence', 'likelihood of submitting an alcohol-negative urine sample', 'Measures\n\n\nAlcohol-negative ethyl glucuronide (EtG) urine test result (defined as EtG<150 ng/mL']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517802', 'cui_str': '52.5'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0001905', 'cui_str': 'Alaska'}, {'cui': 'C0030170', 'cui_str': 'Pacific Northwest'}, {'cui': 'C1515945', 'cui_str': 'American Indian or Alaska native'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0678274', 'cui_str': 'Alcohol Abstinence'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]","[{'cui': 'C0678274', 'cui_str': 'Alcohol Abstinence'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0298229', 'cui_str': 'Ethyl glucuronide'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]",75.0,0.0686201,"Participants randomized to the contingency management group had a higher likelihood of submitting an alcohol-negative urine sample (averaged over time) compared with those randomized to the control group (odds ratio, 1.70; 95% CI, 1.05-2.76; P = .03).
","[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'McDonell', 'Affiliation': 'Department of Medical Education and Clinical Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Hirchak', 'Affiliation': 'Department of Medical Education and Clinical Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane.'}, {'ForeName': 'Jalene', 'Initials': 'J', 'LastName': 'Herron', 'Affiliation': 'Center on Alcoholism, Substance Abuse and Addictions, University of New Mexico, Albuquerque.'}, {'ForeName': 'Abram J', 'Initials': 'AJ', 'LastName': 'Lyons', 'Affiliation': 'Department of Medical Education and Clinical Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane.'}, {'ForeName': 'Karl C', 'Initials': 'KC', 'LastName': 'Alcover', 'Affiliation': 'Department of Medical Education and Clinical Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': 'Southcentral Foundation, Anchorage, Alaska.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Kordas', 'Affiliation': 'Department of Medical Education and Clinical Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Dirks', 'Affiliation': 'Southcentral Foundation, Anchorage, Alaska.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Jansen', 'Affiliation': 'Southcentral Foundation, Anchorage, Alaska.'}, {'ForeName': 'Jaedon', 'Initials': 'J', 'LastName': 'Avey', 'Affiliation': 'Southcentral Foundation, Anchorage, Alaska.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Lillie', 'Affiliation': 'Southcentral Foundation, Anchorage, Alaska.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Donovan', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, Seattle.'}, {'ForeName': 'Sterling M', 'Initials': 'SM', 'LastName': 'McPherson', 'Affiliation': 'Department of Medical Education and Clinical Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Dillard', 'Affiliation': 'Southcentral Foundation, Anchorage, Alaska.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ries', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roll', 'Affiliation': 'Department of Medical Education and Clinical Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane.'}, {'ForeName': 'Dedra', 'Initials': 'D', 'LastName': 'Buchwald', 'Affiliation': 'Department of Medical Education and Clinical Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.4768']
430,33660002,Ultrasound assessment of urethral structure and bladder neck position in women with different parities.,"INTRODUCTION AND HYPOTHESIS


The study aims to compare the urethral sphincter size and bladder neck position and mobility in women with different parities.
METHODS


Women referred to the urodynamics clinic for lower urinary tract and prolapse symptoms were included in the study. A detailed history was taken, and transperineal two- and three-dimensional ultrasound was performed on all the women. The women were divided into four groups according to the vaginal parity. Group 1 had no vaginal childbirths. Group 2 had one, group 3 had two and group 4 had three or more vaginal childbirths. The data was analysed and compared among the groups.
RESULTS


One hundred fifty women were included in the study. There were 34, 22, 48 and 46 women in groups 1 to 4 respectively. The distribution of different urodynamic diagnoses was similar in all four groups. The urethral sphincter measurements were significantly larger in the vaginally nulliparous group than in all other groups. The measurements were not smaller in multiparous women than in primiparous women. The bladder neck was at a lower position at rest in parous women than nulliparous women. The bladder neck movement was not more in groups 2 to 4 than in group 1.
CONCLUSION


The urethral sphincter was smaller and the bladder neck position was lower in parous women than nulliparous women. These differences were not progressive with increasing parity. Request for elective caesarean section during the second pregnancy to protect the urethra is not supported by this study.",2022,"The bladder neck movement was not more in groups 2 to 4 than in group 1.
","['women with different parities', 'parous women than nulliparous women', 'multiparous women than in primiparous women', 'Women referred to the urodynamics clinic for lower urinary tract and prolapse symptoms were included in the study', 'One hundred fifty women were included in the study']",[],"['distribution of different urodynamic diagnoses', 'vaginal childbirths', 'bladder neck', 'bladder neck position', 'urethral sphincter', 'urethral sphincter size and bladder neck position and mobility', 'Ultrasound assessment of urethral structure and bladder neck position', 'bladder neck movement', 'urethral sphincter measurements']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0026751', 'cui_str': 'Multiparous'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4321486', 'cui_str': '150'}]",[],"[{'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0227716', 'cui_str': 'Structure of neck of urinary bladder'}, {'cui': 'C0429795', 'cui_str': 'Bladder neck position'}, {'cui': 'C0457053', 'cui_str': 'Urethral sphincter'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",150.0,0.0392634,"The bladder neck movement was not more in groups 2 to 4 than in group 1.
","[{'ForeName': 'Roopali', 'Initials': 'R', 'LastName': 'Karmarkar', 'Affiliation': 'Chelsea and Westminster NHS Foundation Trust, London, UK. roopalikarmarkar@gmail.com.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Digesu', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Ruwan', 'Initials': 'R', 'LastName': 'Fernando', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Vik', 'Initials': 'V', 'LastName': 'Khullar', 'Affiliation': 'Imperial College London, London, UK.'}]",International urogynecology journal,['10.1007/s00192-021-04715-z']
431,33658605,Peripheral inflammatory biomarkers define biotypes of bipolar depression.,"We identified biologically relevant moderators of response to tumor necrosis factor (TNF)-α inhibitor, infliximab, among 60 individuals with bipolar depression. Data were derived from a 12-week, randomized, placebo-controlled clinical trial secondarily evaluating the efficacy of infliximab on a measure of anhedonia (i.e., Snaith-Hamilton Pleasure Scale). Three inflammatory biotypes were derived from peripheral cytokine measurements using an iterative, machine learning-based approach. Infliximab-randomized participants classified as biotype 3 exhibited lower baseline concentrations of pro- and anti-inflammatory cytokines and soluble TNF receptor-1 and reported greater pro-hedonic improvements, relative to those classified as biotype 1 or 2. Pretreatment biotypes also moderated changes in neuroinflammatory substrates relevant to infliximab's hypothesized mechanism of action. Neuronal origin-enriched extracellular vesicle (NEV) protein concentrations were reduced to two factors using principal axis factoring: phosphorylated nuclear factorκB (p-NFκB), Fas-associated death domain (p-FADD), and IκB kinase (p-IKKα/β) and TNF receptor-1 (TNFR1) comprised factor ""NEV1,"" whereas phosphorylated insulin receptor substrate-1 (p-IRS1), p38 mitogen-activated protein kinase (p-p38), and c-Jun N-terminal kinase (p-JNK) constituted ""NEV2"". Among infliximab-randomized subjects classified as biotype 3, NEV1 scores were decreased at weeks 2 and 6 and increased at week 12, relative to baseline, and NEV2 scores increased over time. Decreases in NEV1 scores and increases in NEV2 scores were associated with greater reductions in anhedonic symptoms in our classification and regression tree model (r 2  = 0.22, RMSE = 0.08). Our findings provide preliminary evidence supporting the hypothesis that the pro-hedonic effects of infliximab require modulation of multiple TNF-α signaling pathways, including NF-κB, IRS1, and MAPK.",2021,"Decreases in NEV1 scores and increases in NEV2 scores were associated with greater reductions in anhedonic symptoms in our classification and regression tree model (r 2  = 0.22, RMSE = 0.08).",['60 individuals with bipolar depression'],"['placebo', 'infliximab', 'Infliximab', 'tumor necrosis factor (TNF)-α inhibitor, infliximab']","['biotype 3, NEV1 scores', 'anhedonic symptoms', 'Neuronal origin-enriched extracellular vesicle (NEV) protein concentrations', 'anhedonia (i.e., Snaith-Hamilton Pleasure Scale', 'NEV1 scores', 'NEV2 scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0441707', 'cui_str': 'Biotyping'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}, {'cui': 'C0427716', 'cui_str': 'Protein concentration, test strip measurement'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",60.0,0.0417392,"Decreases in NEV1 scores and increases in NEV2 scores were associated with greater reductions in anhedonic symptoms in our classification and regression tree model (r 2  = 0.22, RMSE = 0.08).","[{'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada. yenalee.lee@utoronto.ca.'}, {'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': ""Department of Psychiatry, School of Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kapogiannis', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD, USA.'}, {'ForeName': 'Francheska', 'Initials': 'F', 'LastName': 'Delgado-Peraza', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD, USA.'}, {'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Boutilier', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Timothy C Y', 'Initials': 'TCY', 'LastName': 'Chan', 'Affiliation': 'Department of Mechanical and Industrial Engineering, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Carmona', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Rosenblat', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'JungGoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, College of Medicine, Haeundae Paik Hospital, Inje University, Busan, Republic of Korea.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Maletic', 'Affiliation': 'Department of Neuropsychiatry and Behavioral Sciences, University of South Carolina School of Medicine, Greer, SC, USA.'}, {'ForeName': 'Maj', 'Initials': 'M', 'LastName': 'Vinberg', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Benjamin I', 'Initials': 'BI', 'LastName': 'Goldstein', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Arun V', 'Initials': 'AV', 'LastName': 'Ravindran', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Valerie H', 'Initials': 'VH', 'LastName': 'Taylor', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Sahil', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Nogueras-Ortiz', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD, USA.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Ho', 'Affiliation': 'Department of Psychological Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Raison', 'Affiliation': 'School of Human Ecology, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}]",Molecular psychiatry,['10.1038/s41380-021-01051-y']
432,33642724,Second best conduit-is it the tag or patency that counts?,"The Radial Artery Patency and Clinical Outcomes (RAPCO) trial compared radial artery (RA) with free right internal thoracic artery (RITA) and saphenous vein grafts (SVG). This was a prospective, randomized, single-center trial with two separate arms (RA-RITA and RA-SVG). The study showed that RA was superior to free RITA in terms of 10-year angiographic patency and provided a survival advantage as well. In contrast, RA-SVG comparison suggested a trend towards better outcomes with RA but no statistically significant difference in patency or survival. In this appraisal of the RAPCO trial, both the conduct and the findings have been critically evaluated. The concerns over using free RITA as aorto-coronary grafts as opposed to composite grafts and the insufficient sample size for the RA-SVG comparison have been highlighted. In the RAPCO trial that spanned almost quarter of a century, patency of all three conduits studied in the trial appears satisfactory.",2021,"In contrast, RA-SVG comparison suggested a trend towards better outcomes with RA but no statistically significant difference in patency or survival.",[],[],"['patency or survival', 'Radial Artery Patency and Clinical Outcomes (RAPCO) trial compared radial artery (RA) with free right internal thoracic artery (RITA) and saphenous vein grafts (SVG', '10-year angiographic patency']",[],[],"[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0500531', 'cui_str': 'Right internal mammary artery'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0439234', 'cui_str': 'year'}]",3.0,0.063056,"In contrast, RA-SVG comparison suggested a trend towards better outcomes with RA but no statistically significant difference in patency or survival.","[{'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Department of Cardiac Surgery, NH Rabindranath Tagore International Institute of Cardiac Sciences, 124, EM Bypass, Mukundapur, Kolkata, 700099 India.'}]",Indian journal of thoracic and cardiovascular surgery,['10.1007/s12055-020-01105-w']
433,33643877,In Ear Surgeries Intravenous Dexamethasone Preoperatively Decreases Post Operative Sore Throat After Endotracheal Intubation in Adult Patients: A Prospective Randomized Control Study.,"Sore throat is commonly seen after general anaesthesia with endotracheal intubation. It is distressing for the patient as it delays return to work, increases morbidity and bad memories of the surgical period with disturbances in sleep. This double-blinded prospective randomized study was done to know the efficacy of intravenous dexamethasone in decreasing the incidence of postoperative sore throat at 1, 6 and 24 h after tracheal extubation. 60 patients aged 18-50 years scheduled for ear surgeries under general anesthesia with endotracheal intubation, were randomly allocated into two groups A and B. The patients received either intravenous 0.2 mg/kg diluted till 4 ml dexamethasone (group A, n = 30) or 4 ml normal saline (group B, n = 30) prior to induction. Endotracheal intubation was done to secure the airway. Follow up for the incidence of sore throat was done at 1, 6 and 24 h post-extubation. At 1 h, 6 h and 24 h after extubating the patient, the incidence of sore throat in the control group was significantly less in dexamethasone group compared to the control group ( p  < 0.039, 0.024, 0.032) respectively. Prophylactic intravenous dexamethasone in a dose of 0.2 mg/kg can reduce the incidence of postoperative sore throat after extubation with minimal side effects.",2021,Prophylactic intravenous dexamethasone in a dose of 0.2 mg/kg can reduce the incidence of postoperative sore throat after extubation with minimal side effects.,"['postoperative sore throat at 1, 6 and 24\xa0h after tracheal extubation', 'Adult Patients', '60 patients aged 18-50\xa0years scheduled for ear surgeries under general anesthesia with endotracheal intubation']","['intravenous 0.2\xa0mg/kg diluted till 4\xa0ml dexamethasone', 'Endotracheal intubation', '4\xa0ml normal saline', 'Prophylactic intravenous dexamethasone', 'Dexamethasone', 'dexamethasone']",['incidence of sore throat'],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038899', 'cui_str': 'Otologic Surgical Procedure'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}]",60.0,0.30119,Prophylactic intravenous dexamethasone in a dose of 0.2 mg/kg can reduce the incidence of postoperative sore throat after extubation with minimal side effects.,"[{'ForeName': 'Gurchand', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Department of E.N.T., Maharishi Markandeshwar (Deemed to be) University, Mullana, India.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Puri', 'Affiliation': 'Department of Anaesthesia and Critical Care, Maharishi Markandeshwar (Deemed to be) University, Mullana, India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-019-01776-x']
434,33652438,Alternative Flicker Glass: A New Anti-Suppression Approach to the Treatment of Anisometropic Amblyopia.,"INTRODUCTION


Amblyopia always presents with monocular and binocular dysfunction. In this study, we aim to investigate the efficacy of alternative occlusion using liquid crystal glasses versus continuous occlusion therapy using traditional patches for treating amblyopia.
METHODS


Eligible subjects with anisometropic amblyopia were randomized into 2 groups: alternative flicker glass (AFG) or patching group. In the AFG group, subjects were instructed to wear the flicker glasses for 1 h a day. The AFG is a lightweight spectacle frame with liquid crystal lenses that provide direct square-wave alternating occlusion, which were preprogrammed at a temporal frequency of 7 Hz. In the patching group, the patients were prescribed to wear traditional patches for 2 h a day. The best-corrected visual acuity (BCVA), contrast sensitivity function (CSF), and stereoacuity were measured at the baseline and 3 and 12 weeks.
RESULTS


In this pilot study, a total of 40 children were recruited, with 20 in the AFG group. Mean BCVA improved by 0.17 ± 0.14 logMAR (95% CI = 0.10-0.23) in the AFG group and 0.18 ± 0.18 logMAR (95% CI = 0.09-0.26) in the patching group from baseline to 12 weeks. The improvement in BCVA in both groups was significant (both p < 0.01), while there was no significant difference between the groups (p = 0.82). The CSF of both low and high spatial frequencies exhibited significant improvement at 12 weeks in the AFG group (p < 0.01, respectively) and just had a significant improvement at low spatial frequency in the patching group (p < 0.01). The stereoacuity significantly improved by 504.00 ± 848.00 (95% CI = 107.12 to 900.88) arc seconds in the AFG group (p < 0.05), while it was 263.50 ± 639.55 (95% CI = -35.82 to 562.82) arc seconds in the patching group (p > 0.05).
CONCLUSION


Alternative flicker glass was effective in improving both monocular and binocular function, which was most likely achieved by reducing suppression and promoting binocular fusion. This therapy exhibited promise as an alternative method for amblyopia treatment.",2021,"The stereoacuity significantly improved by 504.00±848.00 (95% CI= -900.88 to -107.12) arc seconds in the AFG group (P＜0.05), while 263.50± 639.55 (95% CI=-562.82 to 35.82) arc seconds in the patching group (P＞0.05).
","['Anisometropic Amblyopia', 'Eligible subjects with anisometropic amblyopia', 'a total of forty children were recruited, with twenty in the AFG group']","['Alternative flicker glass', 'Alternative Flicker Glass', 'alternative flicker glass (AFG) or patching group', 'alternative occlusion using liquid crystal glasses versus continuous occlusion therapy']","['Mean BCVA', 'corrected visual acuity (BCVA), contrast sensitivity function (CSF) and stereoacuity', 'monocular and binocular function', 'BCVA']","[{'cui': 'C0339696', 'cui_str': 'Anisometropic amblyopia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0302603', 'cui_str': 'Liquid Crystals'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1444614', 'cui_str': 'Occlusion therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}]",40.0,0.0338321,"The stereoacuity significantly improved by 504.00±848.00 (95% CI= -900.88 to -107.12) arc seconds in the AFG group (P＜0.05), while 263.50± 639.55 (95% CI=-562.82 to 35.82) arc seconds in the patching group (P＞0.05).
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Key Laboratory of Fundus Disease, Shanghai, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'National Clinical Research Center for Eye Diseases, Shanghai, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Yao', 'Affiliation': 'Shanghai Eye Disease Prevention and Treatment Center, Shanghai, China.'}, {'ForeName': 'Xinhui', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Shanghai Eye Disease Prevention and Treatment Center, Shanghai, China.'}, {'ForeName': 'Bilian', 'Initials': 'B', 'LastName': 'Ke', 'Affiliation': 'Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, kebilian@126.com.'}]",Ophthalmic research,['10.1159/000515599']
435,33638104,Robotic-assisted cholecystectomy is superior to laparoscopic cholecystectomy in the initial training for surgical novices in an ex vivo porcine model: a randomized crossover study.,"BACKGROUND


Robotic-assisted surgery (RAS) potentially reduces workload and shortens the surgical learning curve compared to conventional laparoscopy (CL). The present study aimed to compare robotic-assisted cholecystectomy (RAC) to laparoscopic cholecystectomy (LC) in the initial learning phase for novices.
METHODS


In a randomized crossover study, medical students (n = 40) in their clinical years performed both LC and RAC on a cadaveric porcine model. After standardized instructions and basic skill training, group 1 started with RAC and then performed LC, while group 2 started with LC and then performed RAC. The primary endpoint was surgical performance measured with Objective Structured Assessment of Technical Skills (OSATS) score, secondary endpoints included operating time, complications (liver damage, gallbladder perforations, vessel damage), force applied to tissue, and subjective workload assessment.
RESULTS


Surgical performance was better for RAC than for LC for total OSATS (RAC = 77.4 ± 7.9 vs. LC = 73.8 ± 9.4; p = 0.025, global OSATS (RAC = 27.2 ± 1.0 vs. LC = 26.5 ± 1.6; p = 0.012, and task specific OSATS score (RAC = 50.5 ± 7.5 vs. LC = 47.1 ± 8.5; p = 0.037). There were less complications with RAC than with LC (10 (25.6%) vs. 26 (65.0%), p = 0.006) but no difference in operating times (RAC = 77.0 ± 15.3 vs. LC = 75.5 ± 15.3 min; p = 0.517). Force applied to tissue was similar. Students found RAC less physical demanding and less frustrating than LC.
CONCLUSIONS


Novices performed their first cholecystectomies with better performance and less complications with RAS than with CL, while operating time showed no differences. Students perceived less subjective workload for RAS than for CL. Unlike our expectations, the lack of haptic feedback on the robotic system did not lead to higher force application during RAC than LC and did not increase tissue damage. These results show potential advantages for RAS over CL for surgical novices while performing their first RAC and LC using an ex vivo cadaveric porcine model. REGISTRATION NUMBER: researchregistry6029.",2022,"BACKGROUND


Robotic-assisted surgery (RAS) potentially reduces workload and shortens the surgical learning curve compared to conventional laparoscopy (CL).",['medical students (n\u2009=\u200940) in their clinical years performed both'],"['LC and RAC', 'Robotic-assisted cholecystectomy', 'robotic-assisted cholecystectomy (RAC', 'laparoscopic cholecystectomy', 'Robotic-assisted surgery (RAS', 'laparoscopic cholecystectomy (LC', 'conventional laparoscopy (CL']","['surgical performance measured with Objective Structured Assessment of Technical Skills (OSATS) score, secondary endpoints included operating time, complications (liver damage, gallbladder perforations, vessel damage), force applied to tissue, and subjective workload assessment', 'subjective workload for RAS', 'complications with RAC', 'tissue damage']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0151763', 'cui_str': 'Liver damage'}, {'cui': 'C0156215', 'cui_str': 'Perforation of gallbladder'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}]",,0.0355421,"BACKGROUND


Robotic-assisted surgery (RAS) potentially reduces workload and shortens the surgical learning curve compared to conventional laparoscopy (CL).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Willuth', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Hardon', 'Affiliation': 'Department of Surgery, Amsterdam UMC-VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lang', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Haney', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Felinska', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'K F', 'Initials': 'KF', 'LastName': 'Kowalewski', 'Affiliation': 'Department of Urology and Urological Surgery, University Medical Center Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'B P', 'Initials': 'BP', 'LastName': 'Müller-Stich', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Horeman', 'Affiliation': 'Department of BioMechanical Engineering, Delft University of Technology, Delft, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nickel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany. felix.nickel@med.uni-heidelberg.de.'}]",Surgical endoscopy,['10.1007/s00464-021-08373-6']
436,33638105,Ultrasound-guided bilateral subcostal transversus abdominis plane block in gastric cancer patients undergoing laparoscopic gastrectomy: a randomised-controlled double-blinded study.,"BACKGROUND


The effectiveness of subcostal transversus abdominis plane block (TAPB) in laparoscopic gastric cancer surgery is unknown. We aimed to investigate its opioid-sparing and pain-relief effects in laparoscopic gastrectomy for gastric cancer.
METHOD


One hundred and twelve patients undergoing elective laparoscopic gastrectomy were randomised to the TAPB or control group. The TAPB group received ultrasound-guided bilateral subcostal TAPB at the end of surgery, while the control group did not. We investigated fentanyl consumption administered via intravenous patient-controlled analgesia and as a rescue analgesic, the numeric rating scale (NRS) pain scores at rest and during coughing, and the opioid-related side effects at 6, 12, 24, and 48 h postoperatively. The primary outcome was cumulative fentanyl consumption at 24 h postoperatively.
RESULTS


The study included 53 patients in each group. The cumulative fentanyl consumption 24 h postoperatively was significantly lower in the TAPB group than in the control group (median difference -170 mcg, P = 0.03, 95% CI -360 to -15 mcg). Subcostal TAPB also significantly reduced the resting NRS score at 48 h postoperatively (median difference -1, 95% CI -1 to 0, P = 0.01) and coughing NRS score at all time points (all median difference -1, 95% CI -2 to 0, P < 0.01, P  = 0.02, 0.01, and 0.01, respectively). However, it did not reduce the occurrence of opioid-related side effects, except the use of antiemetics during the first 6 h postoperatively (TAPB, 1.9% vs. Control, 15.1%, P = 0.03).
CONCLUSION


Ultrasound-guided bilateral subcostal TAPB provides efficient postoperative analgesia with an opioid-sparing effect after laparoscopic gastrectomy.",2022,"The cumulative fentanyl consumption 24 h postoperatively was significantly lower in the TAPB group than in the control group (median difference -170 mcg, P = 0.03, 95% CI -360 to -15 mcg).","['gastric cancer patients undergoing', 'One hundred and twelve patients undergoing elective laparoscopic gastrectomy', 'laparoscopic gastric cancer surgery', '53 patients in each group']","['laparoscopic gastrectomy', 'TAPB', 'subcostal transversus abdominis plane block (TAPB', 'Ultrasound-guided bilateral subcostal transversus abdominis plane block']","['numeric rating scale (NRS) pain scores', 'cumulative fentanyl consumption at 24\xa0h postoperatively', 'coughing NRS score', 'resting NRS score', 'cumulative fentanyl consumption 24\xa0h postoperatively']","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0442184', 'cui_str': 'Subcostal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",112.0,0.290628,"The cumulative fentanyl consumption 24 h postoperatively was significantly lower in the TAPB group than in the control group (median difference -170 mcg, P = 0.03, 95% CI -360 to -15 mcg).","[{'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Gyu Young', 'Initials': 'GY', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Occupational Safety and Health Research Institute, Ulsan, Republic of Korea.'}, {'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea. zenerdiode03@gmail.com.'}, {'ForeName': 'Seong-Ho', 'Initials': 'SH', 'LastName': 'Kong', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Won Ho', 'Initials': 'WH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Do Joong', 'Initials': 'DJ', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyuk-Joon', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Han-Kwang', 'Initials': 'HK', 'LastName': 'Yang', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.'}]",Surgical endoscopy,['10.1007/s00464-021-08370-9']
437,33662265,Effect of SMS reminders on PrEP adherence in young Kenyan women (MPYA study): a randomised controlled trial.,"BACKGROUND


Pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV acquisition. However, adherence among young women (aged 18-24 years) has been challenging. SMS reminders have been shown to improve adherence to antiretroviral therapy in some contexts, including in combination with real-time adherence monitoring. We aimed to determine the effect of SMS reminders on PrEP adherence among young women in Kenya over a 2-year period.
METHODS


The monitoring PrEP among young adult women (MPYA) study was an open label randomised controlled trial involving young adult women at high risk of HIV in Thika and Kisumu, Kenya. Participants were recruited from colleges, vocational institutions, informal settlements, and community-based organisations supporting young women. Women had to be aged 18-24 years and at high risk of HIV acquisition (defined as a VOICE risk score of 5 or higher, or being in a serodiscordant relationship). Study staff randomly assigned participants (1:1) to receive either SMS reminders (SMS reminder group) or no reminders (no SMS reminder group). Study group assignment was known to trial staff but masked to investigators. Reminders were initially sent daily and participants could switch to as-needed reminders (ie, sent only if they missed opening the monitor as expected) after 1 month. Study visits occurred at 1 month, 3 months, and then quarterly (ie, every 3 months). The primary outcome was PrEP adherence over 24 months measured with a real-time electronic monitor and assessed by negative binomial models adjusted for the study site and quarter among participants who collected PrEP. This trial is registered with ClinicalTrials.gov, NCT02915367.
FINDINGS


Of 642 women initially approached, 348 eligible women were enrolled between Dec 21, 2016, and Feb 5, 2018. Participants were randomly assigned to either the SMS reminder group (n=173) or the no SMS reminder group (n=175). The median age was 21 years (IQR 19-22) and 228 (66%) of the 348 participants reported condomless sex in the month before baseline. 24 (14%) of the 173 participants assigned to receive daily SMS reminders later opted for as-needed reminders. 69 291 (97%) of 71 791 SMS reminders were sent as planned. Among participants collecting PrEP (thus potentially suggesting a desire for HIV protection), electronically monitored adherence averaged 26·8% over 24 months and was similar by study group (27·0% with SMS, 26·6% without SMS, adjusted incidence rate ratio 1·16 [95% CI 0·93-1·45], p=0·19). There were no serious adverse events related to trial participation; five social harms occurred in each study group, primarily related to PrEP use.
INTERPRETATION


SMS reminders were ineffective in promoting PrEP adherence among young Kenyan women. Given the overall low adherence in the trial, additional interventions are needed to support PrEP use in this population.
FUNDING


US National Institute of Mental Health.",2021,"There were no serious adverse events related to trial participation; five social harms occurred in each study group, primarily related to PrEP use.
","['young adult women (MPYA', 'young Kenyan women', '642 women initially approached, 348 eligible women were enrolled between Dec 21, 2016, and', 'Women had to be aged 18-24 years and at high risk of HIV acquisition (defined as a VOICE risk score of 5 or higher, or being in a serodiscordant relationship', 'young adult women at high risk of HIV in Thika and Kisumu, Kenya', 'young women in Kenya over a 2-year period', 'Participants were recruited from colleges, vocational institutions, informal settlements, and community-based organisations supporting young women', 'The median age was 21 years (IQR 19-22) and 228 (66%) of the 348 participants reported condomless sex in the month before baseline', 'young Kenyan women (MPYA study', 'young women (aged 18-24 years']","['Pre-exposure prophylaxis (PrEP', 'SMS reminder group (n=173) or the no SMS reminder', 'SMS reminders', 'SMS reminders (SMS reminder group) or no reminders (no SMS reminder group']","['PrEP adherence over 24 months measured with a real-time electronic monitor and assessed by negative binomial models', 'PrEP adherence']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336646', 'cui_str': 'Electronic monitor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026338', 'cui_str': 'Models, Binomial'}]",348.0,0.307741,"There were no serious adverse events related to trial participation; five social harms occurred in each study group, primarily related to PrEP use.
","[{'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Center for Global Health, Massachusetts General Hospital, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA. Electronic address: jhaberer@mgh.harvard.edu.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya; Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Nelly R', 'Initials': 'NR', 'LastName': 'Mugo', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA; Center for Clinical Research, Kenya Medical Research Institute, Thika, Kenya.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pyra', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kiptinness', 'Affiliation': 'Center for Clinical Research, Kenya Medical Research Institute, Thika, Kenya.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Oware', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Lindsey E', 'Initials': 'LE', 'LastName': 'Garrison', 'Affiliation': 'Center for Global Health, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Thomas', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Musinguzi', 'Affiliation': 'Global Health Collaborative, Mbarara, Uganda.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Morrison', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Anderson', 'Affiliation': 'Department of Pharmaceutical Sciences, University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ngure', 'Affiliation': 'Center for Clinical Research, Kenya Medical Research Institute, Thika, Kenya; Department of Community Heath, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA; Department of Medicine and Department of Epidemiology, University of Washington, Seattle, WA, USA; Gilead Sciences, Redwood City, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30307-6']
438,33668015,Intensified Training Supersedes the Impact of Heat and/or Altitude for Increasing Performance in Elite Rugby Union Players.,"PURPOSE


To investigate whether including heat and altitude exposures during an elite team-sport training camp induces similar or greater performance benefits.
METHODS


The study assessed 56 elite male rugby players for maximal oxygen uptake, repeated-sprint cycling, and Yo-Yo intermittent recovery level 2 (Yo-Yo) before and after a 2-week training camp, which included 5 endurance and 5 repeated-sprint cycling sessions in addition to daily rugby training. Players were separated into 4 groups: (1) control (all sessions in temperate conditions at sea level), (2) heat training (endurance sessions in the heat), (3) altitude (repeated-sprint sessions and sleeping in hypoxia), and (4) combined heat and altitude (endurance in the heat, repeated sprints, and sleeping in hypoxia).
RESULTS


Training increased maximal oxygen uptake (4% [10%], P = .017), maximal aerobic power (9% [8%], P < .001), and repeated-sprint peak (5% [10%], P = .004) and average power (12% [14%], P < .001) independent of training conditions. Yo-Yo distance increased (16% [17%], P < .001) but not in the altitude group (P = .562). Training in heat lowered core temperature and increased sweat rate during a heat-response test (P < .05).
CONCLUSION


A 2-week intensified training camp improved maximal oxygen uptake, repeated-sprint ability, and aerobic performance in elite rugby players. Adding heat and/or altitude did not further enhance physical performance, and altitude appears to have been detrimental to improving Yo-Yo.",2021,"Training in heat lowered core temperature and increased sweat rate during a heat-response test (P < .05).
","['56 elite male rugby players for maximal oxygen uptake, repeated-sprint cycling, and Yo-Yo intermittent recovery level 2 (Yo-Yo) before and after a 2-week training camp, which included 5 endurance and 5 repeated', 'Elite Rugby Union Players', 'elite rugby players']","['control (all sessions in temperate conditions at sea level), (2)\xa0heat training (endurance sessions in the heat), (3)\xa0altitude (repeated-sprint sessions and sleeping in hypoxia), and (4)\xa0combined heat and altitude (endurance in the heat, repeated sprints, and sleeping in hypoxia', 'sprint cycling sessions in addition to daily rugby training']","['repeated-sprint peak', 'maximal oxygen uptake, repeated-sprint ability, and aerobic performance', 'maximal oxygen uptake', 'average power', 'maximal aerobic power', 'sweat rate']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}]",56.0,0.014011,"Training in heat lowered core temperature and increased sweat rate during a heat-response test (P < .05).
","[{'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Racinais', 'Affiliation': ''}, {'ForeName': 'Julien D', 'Initials': 'JD', 'LastName': 'Périard', 'Affiliation': ''}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Piscione', 'Affiliation': ''}, {'ForeName': 'Pitre C', 'Initials': 'PC', 'LastName': 'Bourdon', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Cocking', 'Affiliation': ''}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Ihsan', 'Affiliation': ''}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Lacome', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nichols', 'Affiliation': ''}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Townsend', 'Affiliation': ''}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Travers', 'Affiliation': ''}, {'ForeName': 'Mathew G', 'Initials': 'MG', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Girard', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0630']
439,33662124,Oral Corticosteroids Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Nasal Polyposis: A Randomized Clinical Trial.,"Importance


Although oral corticosteroids are commonly prescribed following endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) without nasal polyposis, there are little data to suggest that this is a beneficial practice.
Objective


To assess the efficacy of oral corticosteroids following ESS in CRS without polyps.
Design, Setting, and Participants


This prospective double-blinded, placebo-controlled, randomized noninferiority clinical trial conducted in a single academic tertiary rhinology practice included adults with CRS without polyps undergoing ESS. Of 81 patients recruited, 72 completed the study.
Interventions


Patients were randomized into 2 treatment groups: a 12-day postoperative taper of oral prednisone vs matched placebo tablets. All study patients also received a uniform 2-week postoperative regimen of oral antibiotics, fluticasone nasal spray, and saline rinses.
Main Outcomes and Measures


The primary outcome measures were Sinonasal Outcome Test-22 (SNOT-22) scores and Lund-Kennedy endoscopy scores, collected preoperatively and postoperatively at 1 week, 1 month, 3 months, and 6 months. Scores were compared between treatment groups at each time point using longitudinal difference between treatment groups and analyzed using 2-way, repeated measures analysis of variance. Secondary outcome measures included treatment-related adverse effects.
Results


Overall, 72 patients (mean [SD] age, 49.4 [14.9] years; 36 men, 36 women) completed the study, with 33 in the prednisone arm and 39 in the placebo arm. When comparing longitudinal differences between treatment groups, there was no clinically meaningful difference observed in SNOT-22 total (F[4254] = 1.71, η2 = 0.01 [95% CI, 0.00-0.05]) or Lund-Kennedy scores (F[4247] = 1.23, η2 = 0.02 [95% CI, 0.00-0.50]). In SNOT-22 subdomain analyses, there was no clinically meaningful difference between treatment groups for rhinologic, extranasal rhinologic, ear/facial, or sleep subdomains. However, the prednisone group had worse longitudinal scores for psychological dysfunction compared with the placebo group (F[4254] = 3.18, η2 = 0.05 [95% CI, 0.02-0.09]). Reported adverse effects were similar between the 2 treatment groups.
Conclusions and Relevance


In this randomized clinical trial of patients with CRS without polyps, oral prednisone following ESS conferred no additional benefit over placebo in terms of SNOT-22 total scores, SNOT-22 rhinologic subscores, or Lund-Kennedy endoscopy scores up to 6 months after surgery. Patients receiving prednisone, however, did demonstrate worse SNOT-22 psychologic subdomain scores. These results suggest that the risks of oral corticosteroids may outweigh the benefits; thus use of oral corticosteroids after ESS for CRS without polyps should be carefully considered.
Trial Registration


ClinicalTrials.gov Identifier: NCT02748070.",2021,"In this randomized clinical trial of patients with CRS without polyps, oral prednisone following ESS conferred no additional benefit over placebo in terms of SNOT-22 total scores, SNOT-22 rhinologic subscores, or Lund-Kennedy endoscopy scores up to 6 months after surgery.","['Chronic Rhinosinusitis Without Nasal Polyposis', 'patients with CRS without polyps, oral', '72 patients (mean [SD] age, 49.4 [14.9] years; 36 men, 36 women) completed the study, with 33 in the prednisone arm and 39 in the placebo arm', '81 patients recruited, 72 completed the study', 'single academic tertiary rhinology practice included adults with CRS without polyps undergoing ESS']","['prednisone following ESS', 'Endoscopic Sinus Surgery', 'prednisone', 'placebo', 'endoscopic sinus surgery (ESS', 'oral antibiotics, fluticasone nasal spray, and saline rinses', 'oral corticosteroids', '12-day postoperative taper of oral prednisone vs matched placebo tablets', 'Oral Corticosteroids']","['Sinonasal Outcome Test-22 (SNOT-22) scores and Lund-Kennedy endoscopy scores', 'SNOT-22 psychologic subdomain scores', 'longitudinal scores for psychological dysfunction', 'SNOT-22 total scores, SNOT-22 rhinologic subscores, or Lund-Kennedy endoscopy scores', 'rhinologic, extranasal rhinologic, ear/facial, or sleep subdomains', 'treatment-related adverse effects', 'adverse effects']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0360577', 'cui_str': 'Fluticasone-containing product in nasal dose form'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",81.0,0.534731,"In this randomized clinical trial of patients with CRS without polyps, oral prednisone following ESS conferred no additional benefit over placebo in terms of SNOT-22 total scores, SNOT-22 rhinologic subscores, or Lund-Kennedy endoscopy scores up to 6 months after surgery.","[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Chang', 'Affiliation': 'Stanford University School of Medicine, Department of Otolaryngology-Head & Neck Surgery, Stanford, California.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Noel', 'Affiliation': 'Stanford University School of Medicine, Department of Otolaryngology-Head & Neck Surgery, Stanford, California.'}, {'ForeName': 'Noel F', 'Initials': 'NF', 'LastName': 'Ayoub', 'Affiliation': 'Stanford University School of Medicine, Department of Otolaryngology-Head & Neck Surgery, Stanford, California.'}, {'ForeName': 'Zhen Jason', 'Initials': 'ZJ', 'LastName': 'Qian', 'Affiliation': 'Stanford University School of Medicine, Department of Otolaryngology-Head & Neck Surgery, Stanford, California.'}, {'ForeName': 'Sachi', 'Initials': 'S', 'LastName': 'Dholakia', 'Affiliation': 'Stanford University School of Medicine, Department of Otolaryngology-Head & Neck Surgery, Stanford, California.'}, {'ForeName': 'Jayakar V', 'Initials': 'JV', 'LastName': 'Nayak', 'Affiliation': 'Stanford University School of Medicine, Department of Otolaryngology-Head & Neck Surgery, Stanford, California.'}, {'ForeName': 'Zara M', 'Initials': 'ZM', 'LastName': 'Patel', 'Affiliation': 'Stanford University School of Medicine, Department of Otolaryngology-Head & Neck Surgery, Stanford, California.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Hwang', 'Affiliation': 'Stanford University School of Medicine, Department of Otolaryngology-Head & Neck Surgery, Stanford, California.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2021.0011']
440,33662112,Overminus Lens Therapy for Children 3 to 10 Years of Age With Intermittent Exotropia: A Randomized Clinical Trial.,"Importance


This is the first large-scale randomized clinical trial evaluating the effectiveness and safety of overminus spectacle therapy for treatment of intermittent exotropia (IXT).
Objective


To evaluate the effectiveness of overminus spectacles to improve distance IXT control.
Design, Setting, and Participants


This randomized clinical trial conducted at 56 clinical sites between January 2017 and January 2019 associated with the Pediatric Eye Disease Investigator Group enrolled 386 children aged 3 to 10 years with IXT, a mean distance control score of 2 or worse, and a refractive error between 1.00 and -6.00 diopters (D). Data analysis was performed from February to December 2020.
Interventions


Participants were randomly assigned to overminus spectacle therapy (-2.50 D for 12 months, then -1.25 D for 3 months, followed by nonoverminus spectacles for 3 months) or to nonoverminus spectacle use.
Main Outcomes and Measures


Primary and secondary outcomes were the mean distance IXT control scores of participants examined after 12 months of treatment (primary outcome) and at 18 months (3 months after treatment ended) assessed by an examiner masked to treatment group. Change in refractive error from baseline to 12 months was compared between groups. Analyses were performed using the intention-to-treat population.
Results


The mean (SD) age of 196 participants randomized to overminus therapy and 190 participants randomized to nonoverminus treatment was 6.3 (2.1) years, and 226 (59%) were female. Mean distance control at 12 months was better in participants treated with overminus spectacles than with nonoverminus spectacles (1.8 vs 2.8 points; adjusted difference, -0.8; 95% CI, -1.0 to -0.5; P < .001). At 18 months, there was little or no difference in mean distance control between overminus and nonoverminus groups (2.4 vs 2.7 points; adjusted difference, -0.2; 95% CI, -0.5 to 0.04; P = .09). Myopic shift from baseline to 12 months was greater in the overminus than the nonoverminus group (-0.42 D vs -0.04 D; adjusted difference, -0.37 D; 95% CI, -0.49 to -0.26 D; P < .001), with 33 of 189 children (17%) in the overminus group vs 2 of 169 (1%) in the nonoverminus group having a shift higher than 1.00 D.
Conclusions and Relevance


Children 3 to 10 years of age had improved distance exotropia control when assessed wearing overminus spectacles after 12 months of overminus treatment; however, this treatment was associated with increased myopic shift. The beneficial effect of overminus lens therapy on distance exotropia control was not maintained after treatment was tapered off for 3 months and children were examined 3 months later.
Trial Registration


ClinicalTrials.gov Identifier: NCT02807350.",2021,"Mean distance control at 12 months was better in participants treated with overminus spectacles than with nonoverminus spectacles (1.8 vs 2.8 points; adjusted difference, -0.8; 95% CI, -1.0 to -0.5; P < .001).","['196 participants randomized to overminus therapy and 190 participants randomized to nonoverminus treatment was 6.3 (2.1) years, and 226 (59%) were female', '56 clinical sites between January 2017 and January 2019 associated with the Pediatric Eye Disease Investigator Group enrolled 386 children aged 3 to 10 years with IXT, a mean distance control score of 2 or worse, and a refractive error between 1.00 and -6.00 diopters (D', 'Children 3 to 10 Years of Age With Intermittent Exotropia']","['overminus spectacle therapy', 'Overminus Lens Therapy', 'overminus lens therapy']","['myopic shift', 'Myopic shift', 'Mean distance control', 'mean distance IXT control scores', 'distance exotropia control', 'mean distance control', 'Change in refractive error']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0423062', 'cui_str': 'Intermittent exotropia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}]","[{'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}]","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0423062', 'cui_str': 'Intermittent exotropia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0730505', 'cui_str': 'Distance exotropia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}]",386.0,0.205915,"Mean distance control at 12 months was better in participants treated with overminus spectacles than with nonoverminus spectacles (1.8 vs 2.8 points; adjusted difference, -0.8; 95% CI, -1.0 to -0.5; P < .001).","[{'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Chen', 'Affiliation': 'Southern California College of Optometry at Marshall B. Ketchum University, Fullerton.'}, {'ForeName': 'S Ayse', 'Initials': 'SA', 'LastName': 'Erzurum', 'Affiliation': 'Eye Care Associates, Inc, Poland, Ohio.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Chandler', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Amra', 'Initials': 'A', 'LastName': 'Hercinovic', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'B Michele', 'Initials': 'BM', 'LastName': 'Melia', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Amit R', 'Initials': 'AR', 'LastName': 'Bhatt', 'Affiliation': ""Texas Children's Hospital, Houston.""}, {'ForeName': 'Donny W', 'Initials': 'DW', 'LastName': 'Suh', 'Affiliation': 'University of Nebraska Medical Center, Omaha.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Vricella', 'Affiliation': 'State University of New York, College of Optometry, New York.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Erickson', 'Affiliation': ""Nemours Children's Clinic, Jacksonville, Florida.""}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Miller', 'Affiliation': 'Houston Eye Associates, The Woodlands, Texas.'}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Marsh', 'Affiliation': ""Children's Mercy Hospitals and Clinics, Kansas City, Missouri.""}, {'ForeName': 'Marie I', 'Initials': 'MI', 'LastName': 'Bodack', 'Affiliation': 'Southern College of Optometry, Memphis, Tennessee.'}, {'ForeName': 'Stacy R', 'Initials': 'SR', 'LastName': 'Martinson', 'Affiliation': 'Virginia Pediatric Eye Center, Virginia Beach.'}, {'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Titelbaum', 'Affiliation': 'Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Gray', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Holtorf', 'Affiliation': ""Arkansas Children's Hospital, University of Arkansas Medical Sciences, Little Rock.""}, {'ForeName': 'Lingkun', 'Initials': 'L', 'LastName': 'Kong', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Kraker', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Rahmani', 'Affiliation': ""Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.""}, {'ForeName': 'Birva K', 'Initials': 'BK', 'LastName': 'Shah', 'Affiliation': 'The Eye Specialist Center, LLC, Munster, Indiana.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Holmes', 'Affiliation': 'University of Arizona, Tucson.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Cotter', 'Affiliation': 'Southern California College of Optometry at Marshall B. Ketchum University, Fullerton.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2021.0082']
441,33675351,Impact of high-dose folic acid supplementation in pregnancy on biomarkers of folate status and 1-carbon metabolism: An ancillary study of the Folic Acid Clinical Trial (FACT).,"BACKGROUND


Periconceptional folic acid (FA) supplementation is recommended to prevent the occurrence of neural tube defects. Currently, most over-the-counter FA supplements in Canada and the United States contain 1 mg FA and some women are prescribed 5 mg FA/d. High-dose FA is hypothesized to impair 1-carbon metabolism. We aimed to determine folate and 1-carbon metabolism biomarkers in pregnant women exposed to 1 mg or 5 mg FA.
OBJECTIVES


This was an ancillary study within the Folic Acid Clinical Trial (FACT), a randomized, double-blinded, placebo-controlled, phase III trial designed to assess the efficacy of high-dose FA to prevent preeclampsia.
METHODS


For FACT, women were randomized at 8-16 gestational weeks to receive daily 4.0 mg FA (high dose) or placebo (low dose) plus their usual supplementation (≤1.1 mg). Women were recruited from 3 Canadian FACT centers and provided nonfasting blood samples at 24-26 gestational weeks for measurement of RBC and serum total folate, serum unmetabolized FA (UMFA), tetrahydrofolate (THF), 5-methylTHF, 5-formylTHF, 5,10-methenylTHF, and MeFox (pyrazino-s-triazine derivative of 4α-hydroxy-5-methylTHF, a 5-methylTHF oxidation product); total vitamins B-12 and B-6; and plasma total homocysteine. Group differences were determined using χ2, Fisher exact, and Wilcoxon rank-sum tests.
RESULTS


Nineteen (38%) women received high-dose FA and 31 (62%) received low-dose FA. The median RBC folate concentration was 2701 (IQR: 2243-3032) nmol/L and did not differ between groups. The high-dose group had higher serum total folate (median: 148.4 nmol/L, IQR: 110.4-181.2; P = 0.007), UMFA (median: 4.6 nmol/L, IQR: 2.5-33.8; P = 0.008), and 5-methylTHF (median: 126.6 nmol/L, IQR: 98.8-158.6; P = 0.03) compared with the low-dose group (median: 122.8 nmol/L, IQR: 99.5-136.0; median: 1.9 nmol/L, IQR: 0.9-4.1; median: 108.6 nmol/L, IQR: 96.4-123.2, respectively). Other biomarkers of 1-carbon metabolism did not differ.
CONCLUSIONS


High-dose FA supplementation in early pregnancy increases maternal serum folate but not RBC folate concentrations, suggesting tissue saturation. Higher UMFA concentrations in women receiving high-dose FA supplements suggest that these doses are supraphysiologic but with no evidence of altered 1-carbon metabolism.",2021,"The high-dose group had higher serum total folate (median: 148.4 nmol/L, IQR: 110.4-181.2; P = 0.007), UMFA (median: 4.6 nmol/L, IQR: 2.5-33.8; P = 0.008), and 5-methylTHF (median: 126.6 nmol/L, IQR: 98.8-158.6; P = 0.03) compared with the low-dose group (median: 122.8 nmol/L, IQR: 99.5-136.0; median: 1.9 nmol/L, IQR: 0.9-4.1; median: 108.6 nmol/L, IQR: 96.4-123.2, respectively).","['Nineteen (38', 'pregnant women exposed to 1 mg or 5 mg FA']","['Periconceptional folic acid (FA) supplementation', 'low-dose FA', 'high-dose folic acid supplementation', 'placebo', 'placebo (low dose) plus their usual supplementation']","['UMFA', 'serum total folate', 'median RBC folate concentration', 'biomarkers of folate status and 1-carbon metabolism', 'RBC and serum total folate, serum unmetabolized FA (UMFA), tetrahydrofolate (THF), 5-methylTHF, 5-formylTHF, 5,10-methenylTHF, and MeFox (pyrazino-s-triazine derivative of 4α-hydroxy-5-methylTHF, a 5-methylTHF oxidation product); total vitamins B-12 and B-6; and plasma total homocysteine', 'folate and 1-carbon metabolism biomarkers', '5-methylTHF']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0427418', 'cui_str': 'Folic acid measurement, RBC'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0039669', 'cui_str': 'Tetrahydrofolates'}, {'cui': 'C1720200', 'cui_str': 'Triazine derivative'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}]",,0.359256,"The high-dose group had higher serum total folate (median: 148.4 nmol/L, IQR: 110.4-181.2; P = 0.007), UMFA (median: 4.6 nmol/L, IQR: 2.5-33.8; P = 0.008), and 5-methylTHF (median: 126.6 nmol/L, IQR: 98.8-158.6; P = 0.03) compared with the low-dose group (median: 122.8 nmol/L, IQR: 99.5-136.0; median: 1.9 nmol/L, IQR: 0.9-4.1; median: 108.6 nmol/L, IQR: 96.4-123.2, respectively).","[{'ForeName': 'Malia S Q', 'Initials': 'MSQ', 'LastName': 'Murphy', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Muldoon', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Hauna', 'Initials': 'H', 'LastName': 'Sheyholislami', 'Affiliation': 'Nutrition Research Division, Health Canada, Ottawa, Ontario, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Behan', 'Affiliation': 'Nutrition Research Division, Health Canada, Ottawa, Ontario, Canada.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Lamers', 'Affiliation': 'Food, Nutrition, and Health Program, Faculty of Land and Food Systems, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rybak', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Ruth Rennicks', 'Initials': 'RR', 'LastName': 'White', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Alysha L J', 'Initials': 'ALJ', 'LastName': 'Harvey', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Gaudet', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Graeme N', 'Initials': 'GN', 'LastName': 'Smith', 'Affiliation': 'Department of Obstetrics and Gynecology, Kingston Health Sciences Centre, Kingston, Ontario, Canada.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Walker', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Shi Wu', 'Initials': 'SW', 'LastName': 'Wen', 'Affiliation': 'OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'MacFarlane', 'Affiliation': 'Nutrition Research Division, Health Canada, Ottawa, Ontario, Canada.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa407']
442,33675344,ω-3 Ethyl ester results in better cognitive function at 12 and 30 months than control in cognitively healthy subjects with coronary artery disease: a secondary analysis of a randomized clinical trial.,"BACKGROUND


Omega-3 (n-3) fatty acids have shown benefit in cognitively impaired subjects, but the effect on cognitively healthy older subjects is unclear.
OBJECTIVES


Our aim was to determine if long-term, high-dose ω-3 ethyl esters, EPA (20:5n-3) and DHA (22:6n-3), prevent deterioration of cognitive function in cognitively healthy older adults.
METHODS


A total of 285 subjects with stable coronary artery disease (CAD) on statin treatment were randomly assigned to 3.36 g EPA and DHA or none (control) for 30 mo. Cognitive function was assessed in all 285 subjects at baseline and in 268 and 250 subjects who returned at 12- and 30-mo follow-up, respectively, with neuropsychological testing as a prespecified secondary outcome. A completer's analysis, along with a sensitivity analysis carrying forward the last observation, was performed.
RESULTS


Over the 30-mo period, subjects randomly assigned to EPA and DHA had significantly better scores than control for verbal fluency, language, and memory (mean: 1.08; 95% CI: 0.25, 1.91; P = 0.011) and 2 tests of visual-motor coordination (mean: -2.95; 95% CI: -5.33, -0.57; P = 0.015 and mean: -9.44; 95% CI: -18.60, -0.30; P = 0.043, respectively). The better scores for EPA and DHA were due to an improvement at 12 mo compared with baseline in verbal fluency, language, and memory (P = 0.047) and 2 tests of visual-motor coordination (P = 0.033 and P < 0.001, respectively), whereas control had no change. Post hoc analyses indicated no difference by age, sex, or diabetes status.
CONCLUSIONS


Cognitively healthy older adults with stable CAD randomly assigned to high-dose EPA and DHA had improved cognitive function over a 30-mo period compared with control. These findings may be especially important for CAD patients because CAD is a risk factor for cognitive decline.This trial was registered at clinicaltrials.gov as NCT01624727.",2021,"Over the 30-mo period, subjects randomly assigned to EPA and DHA had significantly better scores than control for verbal fluency, language, and memory (mean: 1.08; 95% CI: 0.25, 1.91; P = 0.011) and 2 tests of visual-motor coordination (mean:","['285 subjects at baseline and in 268 and 250 subjects who returned at 12- and 30-mo follow-up, respectively, with neuropsychological testing as a prespecified secondary outcome', 'cognitively healthy older subjects', 'cognitively healthy subjects with coronary artery disease', 'cognitively healthy older adults', '285 subjects with stable coronary artery disease (CAD) on statin treatment', 'Cognitively healthy older adults with stable CAD']","['high-dose ω-3 ethyl esters, EPA (20:5n-3) and DHA (22:6n-3', 'Omega-3 (n-3) fatty acids', 'EPA and DHA', 'ω-3 Ethyl ester']","['verbal fluency, language, and memory', 'visual-motor coordination (mean', 'Cognitive function', 'visual-motor coordination', 'cognitive function']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0042828', 'cui_str': 'Visual Motor Coordination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",285.0,0.313364,"Over the 30-mo period, subjects randomly assigned to EPA and DHA had significantly better scores than control for verbal fluency, language, and memory (mean: 1.08; 95% CI: 0.25, 1.91; P = 0.011) and 2 tests of visual-motor coordination (mean:","[{'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'Malik', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Ramadan', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Bhavya', 'Initials': 'B', 'LastName': 'Vemuri', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Wardah', 'Initials': 'W', 'LastName': 'Siddiq', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maral', 'Initials': 'M', 'LastName': 'Amangurbanova', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Aamir', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Francine K', 'Initials': 'FK', 'LastName': 'Welty', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa420']
443,33683435,"One-stage laparoscopic parenchymal sparing liver resection for bilobar colorectal liver metastases: safety, recurrence patterns and oncologic outcomes.","BACKGROUND AND PURPOSE


Laparoscopic liver resections (LLR) of bilobar colorectal liver metastases (CRLM) are challenging and the safety and long-term outcomes are unclear. In this study, the short- and long-term outcomes and recurrence patterns of one-stage LLR for bilobar CRLM were compared to single laparoscopic resection for CRLM.
METHODS


This single-center study consisted of all patients who underwent a parenchymal sparing LLR for CRLM between October 2011 and December 2018. Demographics, perioperative outcomes, short-term outcomes, oncologic outcomes and recurrence patterns were compared. Data were retrieved from a prospectively maintained database.
RESULTS


Thirty six patients underwent a LLR for bilobar CRLM and ninety patients underwent a single LLR. Demographics were similar among groups. More patients received neoadjuvant chemotherapy in the bilobar group (55.6% vs 34.4%, P = 0.03). There was no difference in conversion rate, R0 resection and transfusion rate. Blood loss and operative time were higher in the bilobar group (250 ml (IQR 150-450) vs 100 ml (IQR 50-250), P < 0.001 and 200 min (IQR 170-230) vs 130 min (IQR 100-165), P < 0.001) and hospital stay was longer (5 days (IQR 4-7) vs 4 days (IQR 3-6), P = 0.015). The bilobar group had more technically major resections (88.9% vs 56.7%, P < 0.001). Mortality was nil in both groups and major morbidity was similar (2.8% vs 3.3%, P = 1.0). There was no difference in recurrence pattern. Overall survival (OS) was similar (1 yr: 96% in both groups and 5 yr 76% vs 66%, P = 0.49), as was recurrence-free survival (RFS) (1 yr: 64% vs 73%, 3 yr: 38 vs 42%, 5 yr: 38% vs 28%, P = 0.62).
CONCLUSION


In experienced hands, LLR for bilobar CRLM can be performed safely with similar oncologic outcomes as patients who underwent a single LLR for CRLM.",2022,"The bilobar group had more technically major resections (88.9% vs 56.7%, P < 0.001).","['patients who underwent a parenchymal sparing LLR for CRLM between October 2011 and December 2018', 'Laparoscopic liver resections (LLR) of bilobar colorectal liver metastases (CRLM', 'bilobar colorectal liver metastases', 'Thirty']","['LLR', 'neoadjuvant chemotherapy', 'laparoscopic parenchymal sparing liver resection', 'single LLR']","['Overall survival (OS', 'recurrence-free survival (RFS', 'recurrence pattern', 'Mortality', 'Demographics, perioperative outcomes, short-term outcomes, oncologic outcomes and recurrence patterns', 'Blood loss and operative time', 'technically major resections', 'hospital stay', 'conversion rate, R0 resection and transfusion rate', 'major morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0444465', 'cui_str': 'Bilobar'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",36.0,0.170167,"The bilobar group had more technically major resections (88.9% vs 56.7%, P < 0.001).","[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': ""D'Hondt"", 'Affiliation': 'Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, President Kennedylaan 4, 8500, Kortrijk, Belgium. Mathieudhondt2000@yahoo.com.'}, {'ForeName': 'Zoë', 'Initials': 'Z', 'LastName': 'Pironet', 'Affiliation': 'Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, President Kennedylaan 4, 8500, Kortrijk, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Parmentier', 'Affiliation': 'Department of Oncology and Statistics, Groeninge Hospital Kortrijk, Kortrijk, Belgium.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'De Meyere', 'Affiliation': 'Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, President Kennedylaan 4, 8500, Kortrijk, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Cancer Center Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Pottel', 'Affiliation': 'Interdisciplinary Research Center, Catholic University Leuven, Campus Kortrijk, Kortrijk, Belgium.'}, {'ForeName': 'Franky', 'Initials': 'F', 'LastName': 'Vansteenkiste', 'Affiliation': 'Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, President Kennedylaan 4, 8500, Kortrijk, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Verslype', 'Affiliation': 'Department of Gastroenterology and Hepatology, KU Leuven, Leuven, Belgium.'}]",Surgical endoscopy,['10.1007/s00464-021-08366-5']
444,33667741,Intermittent pneumatic compression after varicose vein surgery.,"OBJECTIVE


Intermittent pneumatic compression (IPC) is an established treatment option to remove tissue fluid from patients with lymphedema and chronic venous disease. The effects of IPC applied directly after varicose vein surgery performed with high volumes of tumescent local anesthesia have not been investigated. The aim of the present study was to evaluate the use of postoperative IPC concerning its effects on the leg volume and patient comfort after surgery.
METHODS


We performed an investigator-initiated, single-center, open-label randomized controlled trial. A total of 186 patients indicated for saphenofemoral junction ligation and great saphenous vein or anterior accessory saphenous vein stripping or great saphenous vein redo surgery were randomly assigned 1:1 to the intervention or control group. The patients in the intervention group were treated with IPC at 40 mm Hg for 45 minutes directly after surgery. The outcome measures were the leg volume changes calculated using an optical three-dimensional scanning system (primary objective), quality of life (QoL; Freiburg Life Quality Assessment for chronic venous disease, short form), pain, and extent of ecchymosis with follow-up examinations on days 1 and 7 after surgery.
RESULTS


The patients in both groups had comparable mean leg volume reductions from baseline to day 1 (IPC group, 58.8 mL; control group, 37.4 mL; P = .967) and to day 7 (63.1 mL and 57.0 mL, respectively; P = .546). We also did not observe significant differences between the two groups in QoL and pain. The patients in the IPC group had developed larger areas of ecchymosis compared with the control group (16% vs 13.3% of leg surface, respectively; P = .046), with a tendency toward an increase in pain at 7 days after surgery compared with no IPC application.
CONCLUSIONS


The present randomized controlled trial was designed to evaluate the decongestive effects of a single postoperative session of IPC and its effect on QoL, pain, and ecchymosis in patients who had undergone varicose vein surgery under tumescent local anesthesia. Because no evidence for a benefit from IPC could be found in the present study and increased ecchymosis was found, its standard use after varicose vein surgery cannot be recommended.",2021,"RESULTS


Patients of both groups had comparable mean leg volume reductions from baseline to day 1 (58.8 ml (IPC group) and 37.4 ml (control group), p= 0,967), and to day 7 (63.1 ml and 57.0 ml respectively, p=0.546).","['patients with lymphedema and chronic venous disease', 'patients undergoing varicose vein surgery under TLA', 'One hundred and eighty-six patients indicated for saphenofemoral junction ligation and great saphenous vein (GSV) or anterior accessory saphenous vein stripping or GSV redo surgery', 'varicose vein surgery']","['IPC', 'Intermittent pneumatic compression (IPC', 'Intermittent pneumatic compression', 'tumescent local anesthesia (TLA']","['leg volume changes calculated by an optical 3D scanning system (primary objective), quality of life (Freiburg Life Quality Assessment for chronic venous disease, short form: FLQA-VS-10), pain and extent of ecchymosis with follow-up examinations on day 1 and 7 after surgery', 'QoL and pain', 'ecchymosis', 'larger areas of ecchymosis', 'mean leg volume reductions', 'QoL, pain, and ecchymosis', 'leg volume and patient comfort']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}, {'cui': 'C0521235', 'cui_str': 'Varicose vein operation'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0447132', 'cui_str': 'Structure of saphenofemoral junction'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0226826', 'cui_str': 'Structure of accessory saphenous vein'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}]",,0.208754,"RESULTS


Patients of both groups had comparable mean leg volume reductions from baseline to day 1 (58.8 ml (IPC group) and 37.4 ml (control group), p= 0,967), and to day 7 (63.1 ml and 57.0 ml respectively, p=0.546).","[{'ForeName': 'Korina', 'Initials': 'K', 'LastName': 'Kappa-Markovi', 'Affiliation': 'Center for Venous and Peripheral Arterial Diseases, Eifelklinik St Brigida, Simmerath, Germany. Electronic address: korinakappa-markovi@hotmail.com.'}, {'ForeName': 'Houman', 'Initials': 'H', 'LastName': 'Jalaie', 'Affiliation': 'European Venous Centre Aachen-Maastricht, University Hospital Aachen, Aachen, Germany.'}, {'ForeName': 'Hilal', 'Initials': 'H', 'LastName': 'Özhan-Hasan', 'Affiliation': 'Center for Venous and Peripheral Arterial Diseases, Eifelklinik St Brigida, Simmerath, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Deges', 'Affiliation': 'Center for Venous and Peripheral Arterial Diseases, Eifelklinik St Brigida, Simmerath, Germany.'}, {'ForeName': 'Knuth', 'Initials': 'K', 'LastName': 'Rass', 'Affiliation': 'Center for Venous and Peripheral Arterial Diseases, Eifelklinik St Brigida, Simmerath, Germany.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2021.02.011']
445,33667319,Prevention of depression in adults with long-term physical conditions.,"BACKGROUND


Major depression is one of the world's leading causes of disability in adults with long-term physical conditions compared to those without physical illness. This co-morbidity is associated with a negative prognosis in terms of increased morbidity and mortality rates, increased healthcare costs, decreased adherence to treatment regimens, and a substantial decline in quality of life. Therefore, preventing the onset of depressive episodes in adults with long-term physical conditions should be a global healthcare aim. In this review, primary or tertiary (in cases of preventing recurrences in those with a history of depression) prevention are the focus. While primary prevention aims at preventing the onset of depression, tertiary prevention comprises both preventing recurrences and prohibiting relapses. Tertiary prevention aims to address a depressive episode that might still be present, is about to subside, or has recently resolved. We included tertiary prevention in the case where the focus was preventing the onset of depression in those with a history of depression (preventing recurrences) but excluded it if it specifically focused on maintaining an condition or implementing rehabilitation services (relapse prevention). Secondary prevention of depression seeks to prevent the progression of depressive symptoms by early detection and treatment and may therefore be considered a 'treatment,' rather than prevention. We therefore exclude the whole spectrum of secondary prevention.
OBJECTIVES


To assess the effectiveness, acceptability and tolerability of psychological or pharmacological interventions, in comparison to control conditions, in preventing depression in adults with long-term physical conditions; either before first ever onset of depressive symptoms (i.e. primary prevention) or before first onset of depressive symptoms in patients with a history of depression (i.e. tertiary prevention).
SEARCH METHODS


We searched the Cochrane Common Mental Disorders Controlled Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO and two trials registries, up to 6 February 2020.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) of preventive psychological or pharmacological interventions, specifically targeting incidence of depression in comparison to treatment as usual (TAU), waiting list, attention/psychological placebo, or placebo. Participants had to be age 18 years or older, with at least one long-term physical condition, and no diagnosis of major depression at baseline (primary prevention). In addition, we included studies comprising mixed samples of patients with and without a history of depression, which explored tertiary prevention of recurrent depression. We excluded other tertiary prevention studies. We also excluded secondary preventive interventions. Primary outcomes included incidence of depression, tolerability, and acceptability. Secondary outcomes included severity of depression, cost-effectiveness and cost-utility.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane.
MAIN RESULTS


We included 11 RCTs, with one trial on psychological interventions, and 10 trials on pharmacological interventions. Data analyses on the psychological intervention (problem-solving therapy compared to TAU) included 194 participants with age-related macular degeneration. Data analyses on pharmacological interventions included 837 participants comparing citalopram (one trial), escitalopram (three trials), a mixed sample of fluoxetine/nortriptyline (one trial), melatonin (one trial), milnacipran (one trial), and sertraline (three trials), each to placebo. Included types of long-term physical conditions were acute coronary syndrome (one trial), breast cancer (one trial), head and neck cancer (two trials), stroke (five trials), and traumatic brain injury (one trial). Psychological interventions Very low-certainty evidence of one study suggests that problem solving therapy may be slightly more effective than TAU in preventing the incidence of depression, immediately post-intervention (odds ratio (OR) 0.43, 95% confidence interval (CI) 0.20 to 0.95; 194 participants). However, there may be little to no difference between groups at six months follow-up (OR 0.71, 95% CI 0.36 to 1.38; 190 participants; one study; very low-certainty evidence). No data were available regarding incidence of depression after six months. Regarding acceptability (drop-outs due to any cause), slightly fewer drop-outs occurred in the TAU group immediately post-intervention (OR 5.21, 95% CI 1.11 to 24.40; 206 participants; low-certainty evidence). After six months, however, the groups did not differ (OR 1.67, 95% CI 0.58 to 4.77; 206 participants; low-certainty evidence). This study did not measure tolerability. Pharmacological interventions Post-intervention, compared to placebo, antidepressants may be beneficial in preventing depression in adults with different types of long-term physical conditions, but the evidence is very uncertain (OR 0.31, 95% CI 0.20 to 0.49; 814 participants; nine studies; I 2  =0%; very low-certainty evidence). There may be little to no difference between groups both immediately and at six months follow-up (OR 0.44, 95% CI 0.08 to 2.46; 23 participants; one study; very low-certainty evidence) as well as at six to 12 months follow-up (OR 0.81, 95% CI 0.23 to 2.82; 233 participants; three studies; I 2  = 49%; very low-certainty evidence). There was very low-certainty evidence from five studies regarding the tolerability of the pharmacological intervention. A total of 669 adverse events were observed in 316 participants from the pharmacological intervention group, and 610 adverse events from 311 participants in the placebo group. There was very low-certainty evidence that drop-outs due to adverse events may be less frequent in the placebo group (OR 2.05, 95% CI 1.07 to 3.89; 561 participants; five studies; I 2  = 0%). There was also very low-certainty evidence that drop-outs due to any cause may not differ between groups either post-intervention (OR 1.13, 95% CI 0.73 to 1.73; 962 participants; nine studies; I 2  = 28%), or at six to 12 months (OR 1.13, 95% CI 0.69 to 1.86; 327 participants; three studies; I 2  = 0%).
AUTHORS' CONCLUSIONS


Based on evidence of very low certainty, our results may indicate the benefit of pharmacological interventions, during or directly after preventive treatment. Few trials examined short-term outcomes up to six months, nor the follow-up effects at six to 12 months, with studies suffering from great numbers of drop-outs and inconclusive results. Generalisation of results is limited as study populations and treatment regimes were very heterogeneous. Based on the results of this review, we conclude that for adults with long-term physical conditions, there is only very uncertain evidence regarding the implementation of any primary preventive interventions (psychological/pharmacological) for depression.",2021,"After six months, however, the groups did not differ (OR 1.67, 95% CI 0.58 to 4.77; 206 participants; low-certainty evidence).","['patients with a history of depression (i.e. tertiary prevention', 'Participants had to be age 18 years or older, with at least one long-term physical condition, and no diagnosis of major depression at baseline (primary prevention', '316 participants from the pharmacological intervention group, and 610 adverse events from 311 participants in the placebo group', '194 participants with age-related macular degeneration', '837 participants comparing citalopram (one trial), escitalopram (three trials), a mixed sample of', 'adults with long-term physical conditions', 'Included types of long-term physical conditions were acute coronary syndrome (one trial), breast cancer (one trial), head and neck cancer (two trials), stroke (five trials), and traumatic brain injury (one trial', 'patients with and without a history of depression, which explored tertiary prevention of recurrent depression']","['placebo', 'psychological intervention (problem-solving therapy compared to TAU', 'melatonin', 'preventive psychological or pharmacological interventions', 'fluoxetine/nortriptyline', 'sertraline', 'usual (TAU), waiting list, attention/psychological placebo, or placebo']","['severity of depression, cost-effectiveness and cost-utility', 'morbidity and mortality rates, increased healthcare costs', 'effectiveness, acceptability and tolerability', 'tolerability', 'incidence of depression, tolerability, and acceptability', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0455503', 'cui_str': 'H/O: depression'}, {'cui': 'C0679700', 'cui_str': 'Tertiary Prevention'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0560182', 'cui_str': 'Diagnosis not made'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0028420', 'cui_str': 'Nortriptyline'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",194.0,0.340148,"After six months, however, the groups did not differ (OR 1.67, 95% CI 0.58 to 4.77; 206 participants; low-certainty evidence).","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Kampling', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Clinic of Giessen and Marburg, Justus-Liebig-University Giessen, Giessen, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Bengel', 'Affiliation': 'Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Mittag', 'Affiliation': 'Section of Health Care Research and Rehabilitation Research, Center for Medical Biometry and Statistics, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011246.pub2']
446,33683016,Unblinding in Randomized Controlled Trials: A Research Ethics Case.,"A pregnant woman was enrolled in a double-blind randomized controlled trial (RCT) in which participants were randomized to a placebo or a drug being tested to prevent a hypertensive complication. After completing the trial, the research participant insisted on being told which drug she received to prepare for a future pregnancy. This case highlights an element of RCT procedure that has received minimal attention-whether to unblind study participants at the end of their participation. Given that unblinding is not standard practice for nonserious adverse events, what actions are justifiable for the investigators to take? To synthesize the information about this case, we used the CASES model, created by the National Center for Ethics in Health Care to analyze ethics cases. Ethical principles that guide research emphasize communication with participants and the importance of reducing harm within the constraints of the scientific goals. Participants may value knowing which drug they received for future health care decision-making. We review information about the benefits and harms of unblinding.",2021,"After completing the trial, the research participant insisted on being told which drug she received to prepare for a future pregnancy.",['A pregnant woman'],['placebo'],['hypertensive complication'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3266050', 'cui_str': 'Hypertensive complication'}]",,0.239717,"After completing the trial, the research participant insisted on being told which drug she received to prepare for a future pregnancy.","[{'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Bhatia', 'Affiliation': 'Research study coordinator in the Department of Psychiatry and Behavioral Sciences at Northwestern University Feinberg School of Medicine.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Appelbaum', 'Affiliation': 'Dollard Professor of Psychiatry, Medicine, & Law, the director of the Division of Law, Ethics, and Psychiatry, and the director of the Center for Research on Ethical, Legal & Social Implications of Psychiatric, Neurologic & Behavioral Genetics at Columbia University College of Physicians & Surgeons.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Wisner', 'Affiliation': 'Norman and Helen Asher Professor of Psychiatry and Behavioral Sciences and Obstetrics and Gynecology, and the director of the Asher Center for the Study and Treatment of Depressive Disorders at Northwestern University Feinberg School of Medicine.'}]",Ethics & human research,['10.1002/eahr.500084']
447,33685375,"Women's perspectives on relationship dynamics with their partners and their role in HIV acquisition, HIV disclosure, hormonal contraceptive uptake, and condom use.","Background : Limited information exists about relationship dynamics and their role in HIV acquisition, HIV disclosure, hormonal contraceptive uptake, and condom use among women in Malawi. Methods : Ninety-seven women aged 18-45 years were randomly assigned to initiate the depot medroxyprogesterone acetate injectable or levonorgestrel implant from May 2014 to April 2015 in Lilongwe, Malawi. Women were recruited after randomisation to participate in semi-structured interviews about HIV and family planning using purposive sampling. Interviews were thematically analysed using within and between group comparisons. Results : We conducted individual interviews and/or focus group discussions with 41 women: 30 (73%) women living with HIV and 11 (27%) women not living with HIV. Most women living with HIV who participated in in-depth interviews disclosed their status to their partners, and most partners agreed to get HIV tested only after disclosure. Nearly all women said their partners agreed to use condoms, but few used them consistently. Nearly all women believed their current and former partners had outside partners. Most women living with HIV who participated in in-depth interviews believed their current or other serious partners were the source of their infection. Some women thought their partner's infidelity was due to their partner's disinterest in sex with them during menstrual/ breakthrough bleeding. Some women included their partners in contraceptive decision-making when the partner was supportive. Discussion : Relationship dynamics affected decision-making for contraceptive and condom use, as well as serodisclosure for the women living with HIV in the study. All women reported challenges with consistent condom use with their male partners, although contraceptive use was generally more acceptable. Women included their partners in their decision-making concerning contraceptive use when they were supportive.",2021,"Relationship dynamics affected decision-making for contraceptive and condom use, as well as serodisclosure for the women living with HIV in the study.","['women living with HIV in the study', 'Methods : Ninety-seven women aged 18-45 years', '41 women: 30 (73%) women living with HIV and 11 (27', 'Discussion ', 'women not living with HIV', 'women in Malawi']","['depot medroxyprogesterone acetate injectable or levonorgestrel implant', ' ']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]",[],97.0,0.0499329,"Relationship dynamics affected decision-making for contraceptive and condom use, as well as serodisclosure for the women living with HIV in the study.","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Chapola', 'Affiliation': 'University of North Carolina Project, Lilongwe, Malawi.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Hatfield-Timajchy', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'Agatha K', 'Initials': 'AK', 'LastName': 'Bula', 'Affiliation': 'University of North Carolina Project, Lilongwe, Malawi.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Hurst', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'Lameck', 'Initials': 'L', 'LastName': 'Chinula', 'Affiliation': 'University of North Carolina Project, Lilongwe, Malawi.'}, {'ForeName': 'Athena P', 'Initials': 'AP', 'LastName': 'Kourtis', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina Project, Lilongwe, Malawi.'}]",African journal of AIDS research : AJAR,['10.2989/16085906.2021.1872664']
448,33675226,Human Antibody Responses Following Vaccinia Immunization Using Protein Microarrays and Correlation With Cell-Mediated Immunity and Antibody-Dependent Cellular Cytotoxicity Responses.,"BACKGROUND


There are limited data regarding immunological correlates of protection for the modified vaccinia Ankara (MVA) smallpox vaccine.
METHODS


A total of 523 vaccinia-naive subjects were randomized to receive 2 vaccine doses, as lyophilized MVA given subcutaneously, liquid MVA given subcutaneously (liquid-SC group), or liquid MVA given intradermally (liquid-ID group) 28 days apart. For a subset of subjects, antibody-dependent cellular cytotoxicity (ADCC), interferon-γ release enzyme-linked immunospot (ELISPOT), and protein microarray antibody-binding assays were conducted. Protein microarray responses were assessed for correlations with plaque reduction neutralization titer (PRNT), enzyme-linked immunosorbent assay, ADCC, and ELISPOT results.
RESULTS


MVA elicited significant microarray antibody responses to 15 of 224 antigens, mostly virion membrane proteins, at day 28 or 42, particularly WR113/D8L and WR101H3L. In the liquid-SC group, responses to 9 antigens, including WR113/D8L and WR101/H3L, correlated with PRNT results. Three were correlated in the liquid-ID group. No significant correlations were observed with ELISPOT responses. In the liquid-ID group, WR052/F13L, a membrane glycoprotein, correlated with ADCC responses.
CONCLUSIONS


MVA elicited antibodies to 15 vaccinia strain antigens representing virion membrane. Antibody responses to 2 proteins strongly increased and significantly correlated with increases in PRNT. Responses to these proteins are potential correlates of protection and may serve as immunogens for future vaccine development.
CLINICAL TRIALS REGISTRATION


NCT00914732.",2021,"RESULTS


MVA elicited significant microarray antibody responses to 15 of 224 antigens, mostly virion membrane proteins, at day 28 or 42, particularly, WR113/D8L and WR101H3L.",['Five hundred twenty-three vaccinia-naïve subjects'],"['lyophilized MVA subcutaneously (SC), liquid MVA SC or liquid MVA', 'vaccinia immunization']","['Antibody responses', 'ELISPOT responses', 'PRNT', 'correlations with PRNT, enzyme-linked immunosorbent assay (ELISA), ADCC and ELISPOT results']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0042214', 'cui_str': 'Vaccinia'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042214', 'cui_str': 'Vaccinia'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0920508', 'cui_str': 'Enzyme linked immunospot assay'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0003272', 'cui_str': 'Antibody-dependent cellular cytotoxicity'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",,0.0222487,"RESULTS


MVA elicited significant microarray antibody responses to 15 of 224 antigens, mostly virion membrane proteins, at day 28 or 42, particularly, WR113/D8L and WR101H3L.","[{'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Frey', 'Affiliation': 'Department of Internal Medicine, Saint Louis University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Jack T', 'Initials': 'JT', 'LastName': 'Stapleton', 'Affiliation': 'Department of Internal Medicine, University of Iowa and Iowa City VA Medical Center, Iowa City, Iowa, USA.'}, {'ForeName': 'Zuhair K', 'Initials': 'ZK', 'LastName': 'Ballas', 'Affiliation': 'Department of Internal Medicine, University of Iowa and Iowa City VA Medical Center, Iowa City, Iowa, USA.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Internal Medicine, University of Iowa and Iowa City VA Medical Center, Iowa City, Iowa, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kaufman', 'Affiliation': 'Department of Internal Medicine, University of Iowa and Iowa City VA Medical Center, Iowa City, Iowa, USA.'}, {'ForeName': 'Tammy P', 'Initials': 'TP', 'LastName': 'Blevins', 'Affiliation': 'Department of Internal Medicine, Saint Louis University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Travis L', 'Initials': 'TL', 'LastName': 'Jensen', 'Affiliation': 'Emmes, Rockville, Maryland, USA.'}, {'ForeName': 'D Huw', 'Initials': 'DH', 'LastName': 'Davies', 'Affiliation': 'Vaccine Research & Development Center, Department of Physiology and Biophysics, School of Medicine, University of California, Irvine, California, USA.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Tary-Lehmann', 'Affiliation': 'Cellular Technology Limited, Shaker Heights, Ohio, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chaplin', 'Affiliation': 'Bavarian Nordic, Martinsried, Germany.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': 'Emmes, Rockville, Maryland, USA.'}, {'ForeName': 'Johannes B', 'Initials': 'JB', 'LastName': 'Goll', 'Affiliation': 'Emmes, Rockville, Maryland, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiab111']
449,33679027,Is continuous locking suture with braided suture sufficient for arthrotomy repair in the conventional TKR? A randomized controlled trial study.,"Introduction


Medial-parapatellar-arthrotomy is the standard approach for total knee replacement(TKR). No studies have clarified the outcomes as quadriceps-strength-recovery (QS) and safety of Continuous-locking-suture-technique(CLS) for the arthrotomy-repair.
Methods


Patients were randomly assigned into a CLS(n = 40) and an interrupted-horizontal-mattress(IHM, n = 40). QS, visual-analog-scale(VAS), modified-timed-up-and-go(TUGT) test, Western-Ontario-and McMasters-Universities-Osteoarthritis-Index[WOMAC] and Knee-Society-Score[KSS] were followed for 6 months'.
Results


A significantly-shorter capsular-closure-time in CLS(233 ± 40 VS 388 ± 47 sec)(p < 0.0001). There were insignificant difference in QS, VAS, TUGT, WOMAC and KSS during the 6-month follow-up period(p > 0.05 all). No wound complications were found.
Conclusion


CLS with braided-suture is safe and effective as demonstrated a recovery of the QS and knee function outcome comparable to IHM.
Trial registration


This study was registered in Thai Clinical Trials Registry on December 2015 (https://www.clinicaltrials.in.th). The registration number was TCTR20151208003.",2021,"There were insignificant difference in QS, VAS, TUGT, WOMAC and KSS during the 6-month follow-up period(p > 0.05 all).","['Thai Clinical Trials Registry on December 2015 (https://www.clinicaltrials.in.th', '47']","['continuous locking suture with braided suture sufficient for arthrotomy repair', 'Introduction\n\n\nMedial-parapatellar-arthrotomy', 'QS, visual-analog-scale(VAS), modified-timed-up-and-go(TUGT) test, Western-Ontario-and McMasters-Universities-Osteoarthritis-Index[WOMAC']","['wound complications', 'QS, VAS, TUGT, WOMAC and KSS']","[{'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0185160', 'cui_str': 'Arthrotomy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0442141', 'cui_str': 'Medial parapatellar approach'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}]",,0.098661,"There were insignificant difference in QS, VAS, TUGT, WOMAC and KSS during the 6-month follow-up period(p > 0.05 all).","[{'ForeName': 'Siwadol', 'Initials': 'S', 'LastName': 'Wongsak', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270, Rama VI Road, Thung Phaya Thai, Ratchathewi District, Bangkok, 10400, Thailand.'}, {'ForeName': 'Kulapat', 'Initials': 'K', 'LastName': 'Chulsomlee', 'Affiliation': 'Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 111 Suwannabhumi Canal Road, Bang Pla, Bang Phli District, Samut Prakan, 10540, Thailand.'}, {'ForeName': 'Chavarat', 'Initials': 'C', 'LastName': 'Jarungvittayakon', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270, Rama VI Road, Thung Phaya Thai, Ratchathewi District, Bangkok, 10400, Thailand.'}, {'ForeName': 'Suphaneewan', 'Initials': 'S', 'LastName': 'Jaovisidha', 'Affiliation': 'Department of Radiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270, Rama VI Road, Thung Phaya Thai, Ratchathewi District, Bangkok, 10400, Thailand.'}, {'ForeName': 'Paphon', 'Initials': 'P', 'LastName': 'Sa-Ngasoongsong', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270, Rama VI Road, Thung Phaya Thai, Ratchathewi District, Bangkok, 10400, Thailand.'}]",Journal of orthopaedics,['10.1016/j.jor.2021.02.011']
450,33676384,Can changes in skin impedance be used to monitor sedation after midazolam and during recovery from anesthesia?,"It has been suggested that sympathetic activity, measured as changes in electrical skin impedance (SI), can be used to assess the adequacy of general anesthesia. Our prospective study investigated if measurements of skin impedance can determine levels of sedation induced by midazolam. Twenty-seven patients scheduled for arthroscopy requiring general anesthesia were served as their own control. These were blinded to the order of injections by telling them that they will be randomly administered a placebo (saline) orsedative agent. A DM 3900 multimeter was used for SI measurements. The degree of sedation was measured using the modified Observer's Assessment of Alertness and Sedation (mOAAS) scale. Resting SI values were noted, and all participants were then administered the placebo followed 5 min later by midazolam 2 mg i.v. Five min after that, patients were administered standard general anesthesia with propofol, oxygen, nitrous oxide 60 %, and isoflurane 1 MAC via a laryngeal mask, and sufentanil 5 - 10 µg. SI significantly increased after administration of midazolam and induction of anesthesia. There were no significant differences between pre-administration (baseline) and placebo and end of surgery and end of anesthesia with closed eyes. There were highly significant differences (p<0.001) between pre-administration vs. midazolam, placebo vs. midazolam, pre-administration vs. induction of anesthesia. We found slight correlation between mOAAS and SI. There were no significant changes between the end of surgery and the end of anesthesia with closed eyes, but SI significantly decreased (p<0.01) after eyes opened.",2021,"There were highly significant differences (p<0.001) between pre-administration vs. midazolam, placebo vs. midazolam, pre-administration vs. induction of anesthesia.",['Twenty-seven patients scheduled for arthroscopy requiring general anesthesia'],"['midazolam, placebo vs. midazolam', 'placebo', 'midazolam', 'propofol, oxygen, nitrous oxide 60%, and isoflurane 1 MAC via a laryngeal mask, and sufentanil', 'placebo (saline) or sedative agent']","['SI', ""modified Observer's Assessment of Alertness and Sedation (mOAAS) scale"", 'degree of sedation', 'Resting SI values']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0036557', 'cui_str': 'Sedative'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",27.0,0.100062,"There were highly significant differences (p<0.001) between pre-administration vs. midazolam, placebo vs. midazolam, pre-administration vs. induction of anesthesia.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kurzová', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hess', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Slíva', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Third Faculty of Medicine, Charles University in Prague, and University Hospital Kralovske Vinohrady, Prague, Czech Republic. Jiri.Sliva@lf3.cuni.cz.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Málek', 'Affiliation': ''}]",Physiological research,[]
451,33668062,Two methods for assessment of choline status in a randomized crossover study with varying dietary choline intake in people: isotope dilution MS of plasma and in vivo single-voxel magnetic resonance spectroscopy of liver.,"BACKGROUND


Choline deficiency has numerous negative health consequences; although the preponderance of the US population consumes less than the recommended Adequate Intake (AI), clinical assessment of choline status is difficult. Further, several pathways involved in primary metabolism of choline are estrogen-sensitive and the AI for premenopausal women is lower than that for men.
OBJECTIVES


We sought to determine whether in vivo magnetic resonance spectroscopy (MRS) of liver and/or isotope-dilution MS of plasma could identify biomarkers reflective of choline intake (preregistered primary outcomes 1 and 2, secondary outcome 1). Determination of whether biomarker concentrations showed sex dependence was a post hoc outcome. This substudy is a component of a larger project to identify a clinically useful biomarker panel for assessment of choline status.
METHODS


In a double-blind, randomized, crossover trial, people consumed 3 diets, representative of ∼100%, ∼50%, and ∼25% of the choline AI, for 2-wk periods. We measured the concentrations of choline and several metabolites using 1H single-voxel MRS of liver in vivo and using 2H-labeled isotope dilution MS of several choline metabolites in extracted plasma.
RESULTS


Plasma concentrations of 2H9-choline, unlabeled betaine, and 2H9-betaine, and the isotopic enrichment ratio (IER) of betaine showed highly significant between-diet effects (q < 0.0001), with unlabeled betaine concentration decreasing 32% from highest to lowest choline intake. Phosphatidylcholine IER was marginally significant (q = 0.03). Unlabeled phosphatidylcholine plasma concentrations did not show between-diet effects (q = 0.34). 2H9 (trimethyl)-phosphatidylcholine plasma concentrations (q = 0.07) and MRS-measured total soluble choline species liver concentrations (q = 0.07) showed evidence of between-diet effects but this was not statistically significant.
CONCLUSIONS


Although MRS is a more direct measure of choline status, variable spectral quality limited interpretation. MS analysis of plasma showed clear correlation of plasma betaine concentration, but not plasma phosphatidylcholine concentration, with dietary choline intake. Plasma betaine concentrations also correlate with sex status (premenopausal women, postmenopausal women, men).This trial was registered at clinicaltrials.gov as NCT03726671.",2021,"MS analysis of plasma showed clear correlation of plasma betaine concentration, but not plasma phosphatidylcholine concentration, with dietary choline intake.","['people', 'sex status (premenopausal women, postmenopausal women']","['varying dietary choline intake', 'vivo magnetic resonance spectroscopy (MRS) of liver and/or isotope-dilution MS of plasma']","['Plasma concentrations of 2H9-choline, unlabeled betaine, and 2H9-betaine, and the isotopic enrichment ratio (IER) of betaine', 'unlabeled betaine concentration', 'Phosphatidylcholine IER', 'Plasma betaine concentrations', 'MRS-measured total soluble choline species liver concentrations', '2H9 (trimethyl)-phosphatidylcholine plasma concentrations', 'Unlabeled phosphatidylcholine plasma concentrations']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022262', 'cui_str': 'Isotope'}, {'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}]",,0.162441,"MS analysis of plasma showed clear correlation of plasma betaine concentration, but not plasma phosphatidylcholine concentration, with dietary choline intake.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Horita', 'Affiliation': 'Nutrition Research Institute, University of North Carolina at Chapel Hill, Kannapolis, NC, USA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': 'Nutrition Research Institute, University of North Carolina at Chapel Hill, Kannapolis, NC, USA.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Stegall', 'Affiliation': 'Nutrition Research Institute, University of North Carolina at Chapel Hill, Kannapolis, NC, USA.'}, {'ForeName': 'Walter B', 'Initials': 'WB', 'LastName': 'Friday', 'Affiliation': 'Nutrition Research Institute, University of North Carolina at Chapel Hill, Kannapolis, NC, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Kirchner', 'Affiliation': 'Nutrition Research Institute, University of North Carolina at Chapel Hill, Kannapolis, NC, USA.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Zeisel', 'Affiliation': 'Nutrition Research Institute, University of North Carolina at Chapel Hill, Kannapolis, NC, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa439']
452,33668058,Effects of dietary macronutrients on serum urate: results from the OmniHeart trial.,"BACKGROUND


Dietary recommendations to prevent gout emphasize a low-purine diet. Recent evidence suggests that the Dietary Approaches to Stop Hypertension (DASH) diet reduces serum urate while also improving blood pressure and lipids.
OBJECTIVE


To compare the effects of DASH-style diets emphasizing different macronutrient proportions on serum urate reduction.
METHODS


We conducted a secondary analysis of the Optimal Macronutrient Intake Trial to Prevent Heart Disease feeding study, a 3-period, crossover design, randomized trial of adults with prehypertension or hypertension. Participants were provided with 3 DASH-style diets in random order, each for 6 wk. Each DASH-style diet emphasized different macronutrient proportions: a carbohydrate-rich (CARB) diet, a protein-rich (PROT) diet, and an unsaturated fat-rich (UNSAT) diet. In the PROT diet, approximately half of the protein came from plant sources. We compared the effects of these diets on serum urate at weeks 4 and 6 of each feeding period.
RESULTS


Of the 163 individuals included in the final analysis, the mean serum urate at baseline was 5.1 mg/dL. Only the PROT diet reduced serum urate from baseline at the end of the 6-wk feeding period (-0.16 mg/dL; 95% CI: -0.28, -0.04; P = 0.007). Neither the CARB diet (-0.03 mg/dL; 95% CI: -0.14, 0.09; P = 0.66) nor the UNSAT diet (-0.01 mg/dL; 95% CI: -0.12, 0.09; P = 0.78) reduced serum urate from baseline. The PROT diet lowered serum urate by 0.12 mg/dL (95% CI: -0.20, -0.03; P = 0.006) compared with CARB and by 0.12 mg/dL (95% CI: -0.20, -0.05; P = 0.002) compared with UNSAT.
CONCLUSIONS


A DASH-style diet emphasizing plant-based protein lowered serum urate compared with those emphasizing carbohydrates or unsaturated fat. Future trials should test the ability of a DASH-style diet emphasizing plant-based protein to lower serum urate and prevent gout flares in patients with gout. This trial was registered at clinicaltrials.gov as NCT00051350.",2021,"The PROT diet lowered serum urate by 0.12 mg/dL (95% CI: -0.20, -0.03; P = 0.006) compared with CARB and by 0.12 mg/dL (95% CI: -0.20, -0.05; P = 0.002) compared with UNSAT.
","['adults with prehypertension or hypertension', 'patients with gout']","['carbohydrate-rich (CARB) diet, a protein-rich (PROT) diet, and an unsaturated fat-rich (UNSAT) diet', 'dietary macronutrients', 'DASH-style diets']","['mean serum urate', 'blood pressure and lipids', 'serum urate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018099', 'cui_str': 'Gout'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015678', 'cui_str': 'Unsaturated fat'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",163.0,0.0537171,"The PROT diet lowered serum urate by 0.12 mg/dL (95% CI: -0.20, -0.03; P = 0.006) compared with CARB and by 0.12 mg/dL (95% CI: -0.20, -0.05; P = 0.002) compared with UNSAT.
","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Belanger', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Wee', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Johns Hopkins University, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Shmerling', 'Affiliation': 'Division of Rheumatology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hyon K', 'Initials': 'HK', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, Division of Rheumatology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa424']
453,33674558,Effects of glossopharyngeal insufflation on pulmonary function in cervical cord injury patients.,"STUDY DESIGN


Quasi experimental.
OBJECTIVE


To evaluate the effect of glossopharyngeal insufflation on pulmonary function in cervical cord injury.
SETTING


Indian Spinal Injuries Centre, Vasant Kunj, Delhi, India.
METHODS


Thirty-one cervical cord injured (ISNCSCI A and B) subjects received respiratory rehabilitation for 4 weeks, with the experimental group performing glossopharyngeal insufflation along with respiratory rehabilitation. The groups were assessed at baseline and after 4 weeks for pulmonary function test, chest expansion, dyspnea, and chest tightness.
RESULTS


Significant differences were observed in IVC, IC, FVC, FEV1, MEF 75%, PEF, tidal volume, chest expansion, dyspnea, and chest tightness (p < 0.05).
CONCLUSION


Glossopharyngeal insufflation is a technique that can be used to improve the respiratory function after cervical cord injury.",2021,"RESULTS


Significant differences were observed in IVC, IC, FVC, FEV1, MEF 75%, PEF, tidal volume, chest expansion, dyspnea, and chest tightness (p < 0.05).
","['cervical cord injury patients', 'Indian Spinal Injuries Centre, Vasant Kunj, Delhi, India', 'Quasi experimental', 'Thirty-one cervical cord injured (ISNCSCI A and B) subjects received']","['respiratory rehabilitation for 4 weeks, with the experimental group performing glossopharyngeal insufflation along with respiratory rehabilitation', 'Glossopharyngeal insufflation', 'glossopharyngeal insufflation']","['pulmonary function', 'pulmonary function test, chest expansion, dyspnea, and chest tightness', 'IVC, IC, FVC, FEV1, MEF 75%, PEF, tidal volume, chest expansion, dyspnea, and chest tightness']","[{'cui': 'C0457846', 'cui_str': 'Segment of cervical spinal cord'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0037937', 'cui_str': 'Spinal injury'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0450355', 'cui_str': '31'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0231902', 'cui_str': 'Chest expansion'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0232292', 'cui_str': 'Tight chest'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0030771', 'cui_str': 'Pefloxacin'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",31.0,0.0341704,"RESULTS


Significant differences were observed in IVC, IC, FVC, FEV1, MEF 75%, PEF, tidal volume, chest expansion, dyspnea, and chest tightness (p < 0.05).
","[{'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'ISIC Institute of Rehabilitation Sciences, Vasant Kunj, Delhi, India. akankshasharma1097@gmail.com.'}, {'ForeName': 'Shambhovi', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'ISIC Institute of Rehabilitation Sciences, Vasant Kunj, Delhi, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Dutta', 'Affiliation': 'Indian Spinal Injuries Centre, Vasant Kunj, Delhi, India.'}, {'ForeName': 'Jamal Ali', 'Initials': 'JA', 'LastName': 'Moiz', 'Affiliation': 'Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Delhi, India.'}]",Spinal cord series and cases,['10.1038/s41394-021-00390-w']
454,33694035,Can we enhance compliance to treatment by performing a continuous positive airway pressure trial in obstructive sleep apnea?,"BACKGROUND


Although continuous positive airway pressure (CPAP) therapy is the most effective treatment for obstructive sleep apnea (OSA), it is not always easy to gain adherence to therapy. We aimed to evaluate how short-term CPAP application during the daytime before the titration night affects polysomnographic data and CPAP adherence in OSA.
METHODS


Patients with moderate to severe OSA for whom CPAP titration was recommended were prospectively randomized to daytime CPAP application (group 1) or usual care (group 2).  For group 1, CPAP was applied for 30-60 min in daytime conditions to acclimate patients to the device. An appointment was then made to perform CPAP titration with PSG. In group 2 (usual care), the first CPAP application was performed on the titration night. PSG recordings and titration night recordings of both groups were compared. All subjects were evaluated 1 month after the initiation of CPAP treatment.
RESULTS


Among 246 cases, first night data were similar in both groups. During the titration night, total sleep time, sleep efficiency, and time in stage N3 were significantly higher in patients who underwent the daytime CPAP trial. Adherence to CPAP treatment at first-month follow-up was significantly higher in the group 1 (5.7 ± 1.0 h/night) compared to the group 2 (3.9 ± 1.1 h/night, p < 0.001).
CONCLUSION


A short-term daytime CPAP trial in patients before the titration night may provide longer and more efficient sleep on the titration night and better CPAP adherence at one month.",2021,"During the titration night, total sleep time, sleep efficiency, and time in stage N3 were significantly higher in patients who underwent the daytime CPAP trial.","['Patients with moderate to severe OSA for whom CPAP titration', 'obstructive sleep apnea (OSA']","['daytime CPAP application (group 1) or usual care (group 2', 'continuous positive airway pressure (CPAP) therapy']","['total sleep time, sleep efficiency, and\xa0time in stage N3', 'PSG recordings and titration night recordings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C2960045', 'cui_str': 'Continuous positive airway pressure titration'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",,0.00943435,"During the titration night, total sleep time, sleep efficiency, and time in stage N3 were significantly higher in patients who underwent the daytime CPAP trial.","[{'ForeName': 'Elif Torun', 'Initials': 'ET', 'LastName': 'Parmaksız', 'Affiliation': 'Department of Chest Diseases, Health Sciences University, Kartal Dr Lutfi Kırdar City Hospital, Istanbul, Turkey. dreliftorun@yahoo.com.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-021-02340-0']
455,33674869,Targeted Antibiotics for Trachoma: A Cluster-Randomized Trial.,"BACKGROUND


Current guidelines recommend community-wide mass azithromycin for trachoma, but a targeted treatment strategy could reduce the volume of antibiotics required.
METHODS


In total, 48 Ethiopian communities were randomized to mass, targeted, or delayed azithromycin distributions. In the targeted arm, only children aged 6 months to 5 years with evidence of ocular chlamydia received azithromycin, distributed thrice over the following year. The primary outcome was ocular chlamydia at months 12 and 24, comparing the targeted and delayed arms (0-5 year-olds, superiority analysis) and the targeted and mass azithromycin arms (8-12 year-olds, noninferiority analysis, 10% noninferiority margin).
RESULTS


At baseline, the mean prevalence of ocular chlamydia in the 3 arms ranged from 7% to 9% among 0-5 year-olds and from 3% to 9% among 8-12 year-olds. Averaged across months 12-24, the mean prevalence of ocular chlamydia among 0-5 year-olds was 16.7% (95% confidence interval [CI]: 9.0%-24.4%) in the targeted arm and 22.3% (95% CI: 11.1%-33.6%) in the delayed arm (P = .61). The final mean prevalence of ocular chlamydia among 8-12 year-olds was 13.5% (95% CI: 7.9%-19.1%) in the targeted arm and 5.5% (95% CI: 0.3%-10.7%) in the mass treatment arm (adjusted risk difference 8.5 percentage points [pp] higher in the targeted arm, 95% CI: 0.9 pp-16.1 pp higher).
CONCLUSIONS


Antibiotic treatments targeted to infected preschool children did not result in significantly less ocular chlamydia infections compared with untreated communities and did not meet noninferiority criteria relative to mass azithromycin distributions. Targeted approaches may require treatment of a broader segment of the population in areas with hyperendemic trachoma.",2021,"CONCLUSIONS


Antibiotic treatments targeted to infected pre-school children did not result in significantly less ocular chlamydia infections compared with untreated communities, and did not meet non-inferiority criteria relative to mass azithromycin distributions.","['children aged 6 months to 5 years with evidence of ocular chlamydia received', '48 Ethiopian communities']","['azithromycin', 'azithromycin distributions']","['final mean prevalence of ocular chlamydia', 'ocular chlamydia', 'ocular chlamydia infections', 'mean prevalence of ocular chlamydia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0008149', 'cui_str': 'Chlamydial infection'}]",,0.217567,"CONCLUSIONS


Antibiotic treatments targeted to infected pre-school children did not result in significantly less ocular chlamydia infections compared with untreated communities, and did not meet non-inferiority criteria relative to mass azithromycin distributions.","[{'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Melo', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Aragie', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Ambahun', 'Initials': 'A', 'LastName': 'Chernet', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Zerihun', 'Initials': 'Z', 'LastName': 'Tadesse', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Adane', 'Initials': 'A', 'LastName': 'Dagnew', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Dagnachew', 'Initials': 'D', 'LastName': 'Hailu', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Mahteme', 'Initials': 'M', 'LastName': 'Haile', 'Affiliation': 'Amhara Public Health Institute, Bahir Dar, Ethiopia.'}, {'ForeName': 'Tàye', 'Initials': 'T', 'LastName': 'Zeru', 'Affiliation': 'Amhara Public Health Institute, Bahir Dar, Ethiopia.'}, {'ForeName': 'Dionna M', 'Initials': 'DM', 'LastName': 'Wittberg', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Nash', 'Affiliation': 'The Carter Center, Atlanta, Georgia, USA.'}, {'ForeName': 'E Kelly', 'Initials': 'EK', 'LastName': 'Callahan', 'Affiliation': 'The Carter Center, Atlanta, Georgia, USA.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciab193']
456,33674863,Contextual Predictors of Engagement in a Tailored mHealth Intervention for Adolescent and Young Adult Cancer Survivors.,"BACKGROUND


Despite the promise of mobile health (mHealth), engagement is often too low for durable health behavior change, and little is known regarding why certain individuals abandon mHealth tools.
PURPOSE


Guided by a mHealth engagement framework, we evaluated contextual predictors of objective engagement with an app for adolescents and young adults (AYA) who survived cancer.
METHODS


One hundred and ten AYA survivors (M age = 20.5, 43% female, 30% racial/ethnic minority) were randomized to receive a disease self-management app that delivered 1-2 tailored messages/day for 16 weeks, and contained a survivorship care plan (SCP). Demographic, disease, psychosocial, and setting characteristics were examined as predictors of three objective engagement outcomes: (a) % of active app days, (b) % of messages read, and (c) viewed SCP in the app versus not. A subsample (n = 10) completed qualitative interviews to further assess engagement barriers.
RESULTS


Self-reported uninterrupted app access (β = -0.56, p < .001), iPhone (vs. Android) ownership (β = 0.30, p < .001), and receiving the intervention in the summer (β = -0.20, p = .01) predicted more active days. Lower depressed mood (β = -0.30, p = .047) and uninterrupted app access (β = -0.50, p < .001) predicted more messages read. Qualitatively, technical glitches and competing priorities were described as engagement barriers, whereas certain types of messages (e.g., health goal messages) were perceived as engaging. Among participants who had uninterrupted app access (n = 76), higher baseline motivation to change, better health perceptions, using the app during the summer, and iPhone ownership predicted higher engagement.
CONCLUSIONS


Findings demonstrate the importance of comprehensively assessing and planning for multi-level ecological determinants of mHealth engagement in future trials.
CLINICALTRIALS.GOV IDENTIFIER


NCT03363711.",2021,"RESULTS


Self-reported uninterrupted app access (β = -0.56, p < .001), iPhone (vs. Android) ownership (β = 0.30, p < .001), and receiving the intervention in the summer (β = -0.20, p = .01) predicted more active days.","['adolescents and young adults (AYA) who survived cancer', 'participants who had uninterrupted app access (n = 76', 'Adolescent and Young Adult Cancer Survivors', 'One hundred and ten AYA survivors (M age = 20.5, 43% female, 30% racial/ethnic minority']","['Tailored mHealth Intervention', 'disease self-management app that delivered 1-2 tailored messages/day for 16 weeks, and contained a survivorship care plan (SCP']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}]",[],110.0,0.224919,"RESULTS


Self-reported uninterrupted app access (β = -0.56, p < .001), iPhone (vs. Android) ownership (β = 0.30, p < .001), and receiving the intervention in the summer (β = -0.20, p = .01) predicted more active days.","[{'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Psihogios', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'King-Dowling', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': ""O'Hagan"", 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Darabos', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Maurer', 'Affiliation': 'Tennessee Department of Health, Nashville, TN, USA.'}, {'ForeName': 'Jordyn', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Fleisher', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Lamia P', 'Initials': 'LP', 'LastName': 'Barakat', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Dava', 'Initials': 'D', 'LastName': 'Szalda', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Hill-Kayser', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Schwartz', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaab008']
457,33674858,Using Positive Attribute Framing to Attenuate Nocebo Side Effects: A Cybersickness Study.,"BACKGROUND


Side effect warnings can contribute directly to their occurrence via the nocebo effect. This creates a challenge for clinicians and researchers, because warnings are necessary for informed consent, but can cause harm. Positive framing has been proposed as a method for reducing nocebo side effects whilst maintaining the principles of informed consent, but the limited available empirical data are mixed.
PURPOSE


To test whether positive attribute framing reduces nocebo side effects relative to negative framing, general warning, and no warning.
METHODS


Ninety-nine healthy volunteers were recruited under the guise of a study on virtual reality (VR) and spatial awareness. Participants were randomized to receive positively framed (""7 out of 10 people will not experience nausea""), negatively framed (""3 out of 10 people will experience nausea""), general (""a proportion of people will experience nausea""), or no side effect warnings prior to VR exposure.
RESULTS


Receiving a side effect warning increased VR cybersickness relative to no warning overall, confirming that warnings can induce nocebo side effects. Importantly, however, positive framing reduced cybersickness relative to both negative framing and the general warning, with no difference between the latter two. Further, there was no difference in side effects between positive framing and no warning.
CONCLUSIONS


These findings suggest that positive framing not only reduces nocebo side effects relative to negative framing and general warnings, but actually prevents nocebo side effects from occurring at all. As such, positive attribute framing may be a cheap and ethical way to reduce nocebo side effects.",2021,"Receiving a side effect warning increased VR cybersickness relative to no warning overall, confirming that warnings can induce nocebo side effects.",['Ninety-nine healthy volunteers were recruited under the guise of a study on virtual reality (VR) and spatial awareness'],[],"['side effects', 'VR cybersickness']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0584950', 'cui_str': 'Spatial awareness'}]",[],"[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]",99.0,0.0368161,"Receiving a side effect warning increased VR cybersickness relative to no warning overall, confirming that warnings can induce nocebo side effects.","[{'ForeName': 'Alanna', 'Initials': 'A', 'LastName': 'Mao', 'Affiliation': 'School of Psychology, University of Sydney, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Barnes', 'Affiliation': 'School of Psychology, University of Sydney, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Sharpe', 'Affiliation': 'School of Psychology, University of Sydney, Australia.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Geers', 'Affiliation': 'Department of Psychology, University of Toledo.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Helfer', 'Affiliation': 'Department of Psychology, Adrian College.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Faasse', 'Affiliation': 'School of Psychology, University of New South Wales, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Colagiuri', 'Affiliation': 'School of Psychology, University of Sydney, Australia.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa115']
458,33678909,A Comprehensive Examination of Factors Impacting Collegiate Athletes' Utilization of Psychological Assessment and Intervention Services.,"Although collegiate athletes underutilize mental health programming, investigators have rarely examined factors that may influence their participation in such programs. The current study examined how structured interviews and demographic factors influence collegiate athletes to use psychological programming. Two-hundred and eighty-nine collegiate athletes were referred to the study. They were screened for mental health and randomly assigned to one of two semi-structured interviews based on experimental phase. Participants in Phase I received standard engagement (SE; N = 35) or SE+discussion of mental health (DMH; N = 44). Phase II participants received SE+DMH (N = 82) or SE+DMH + discussion of personal ambitions (DPA; N = 66). Phase III participants received SE+DMH+discussion about their culture of choice (DCC) (N = 25) or SE+DMH+discussion of sport culture (DSC) (N = 37). After receiving the respective interview participants were offered psychological assessment and intervention. Chi squared analyses revealed class standing, mental health symptom severity, referral type, and type of engagement interview influenced program commitment/utilization. Logistic regression analyses indicated SE+DMH+DPA and SE+DMH+DSC uniquely improved assessment attendance whereas referrals from the athletic department and coaches/teammates, participation in sport performance workshops, and senior status uniquely improved assessment and intervention attendance.",2021,"Logistic regression analyses indicated SE+DMH+DPA and SE+DMH+DSC uniquely improved assessment attendance whereas referrals from the athletic department and coaches/teammates, participation in sport performance workshops, and senior status uniquely improved assessment and intervention attendance.","['Participants in Phase', 'Two-hundred and eighty-nine collegiate athletes']","['SE+DMH+DPA and SE+DMH+DSC', 'SE+DMH+discussion about their culture of choice (DCC) (N = 25) or SE+DMH+discussion of sport culture (DSC', 'standard engagement (SE; N = 35) or SE+discussion of mental health', 'SE+DMH (N = 82) or SE+DMH + discussion of personal ambitions']","['class standing, mental health symptom severity, referral type, and type of engagement interview influenced program commitment/utilization']","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",289.0,0.0136786,"Logistic regression analyses indicated SE+DMH+DPA and SE+DMH+DSC uniquely improved assessment attendance whereas referrals from the athletic department and coaches/teammates, participation in sport performance workshops, and senior status uniquely improved assessment and intervention attendance.","[{'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Donohue', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gavrilova', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Danlag', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Perry', 'Affiliation': 'Orthopedic Service Line, Novant Health, Charlotte, NC USA.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Kuhn', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Allen', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Benning', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, NV, USA.'}]",Psychology in the schools,['10.1002/pits.22458']
459,33689118,A Family-Based Healthy Lifestyle Intervention: Crossover Effects on Substance Use and Sexual Risk Behaviors.,"This study examined the efficacy of a healthy lifestyle family-based intervention in reducing substance use and sexual risk behaviors compared with prevention as usual over 24 months in Hispanic adolescents. Participants were overweight/obese Hispanic adolescents (N = 280; M age 13.01; SD = .82) in the 7th/8th grade and their primary caregivers. Participants were randomized to either the healthy lifestyle family-based intervention or to the control condition (i.e., referral to community services offered for overweight and/or obese adolescents and their families). Outcomes included adolescent substance use and sexual risk behaviors among adolescents. Intervention effects were found for adolescent alcohol (b = - 0.37, 95% CI = [- 0.49, - 0.26]), marijuana (b = - 1.00, CI = [- 1.22, - 0.78]), and non-prescription drug use (b = - 3.77, CI = [- 6.49, - 1.05]) over 24 months. No significant intervention effects were found for adolescent sexual risk behaviors. Findings suggest that Familias Unidas for Health and Wellness reduces adolescent alcohol, marijuana, and non-prescription drug use across time. ClinicalTrials.gov Identifier: NCT03943628.",2021,"Intervention effects were found for adolescent alcohol (b = - 0.37, 95% CI = [- 0.49, - 0.26]), marijuana (b = - 1.00, CI = [- 1.22, - 0.78]), and non-prescription drug use (b = - 3.77, CI = [- 6.49, - 1.05]) over 24 months.","['for overweight and/or obese adolescents and their families', 'Hispanic adolescents', 'Participants were overweight/obese Hispanic adolescents (N\u2009=\u2009280; M age 13.01; SD\u2009=\u2009.82) in the 7th/8th grade and their primary caregivers']","['healthy lifestyle family-based intervention', 'Healthy Lifestyle Intervention', 'healthy lifestyle family-based intervention or to the control condition (i.e., referral to community services offered']","['adolescent alcohol', 'Substance Use and Sexual Risk Behaviors', 'adolescent sexual risk behaviors', 'substance use and sexual risk behaviors', 'adolescent substance use and sexual risk behaviors']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4040088', 'cui_str': 'Referral to community service'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0267888,"Intervention effects were found for adolescent alcohol (b = - 0.37, 95% CI = [- 0.49, - 0.26]), marijuana (b = - 1.00, CI = [- 1.22, - 0.78]), and non-prescription drug use (b = - 3.77, CI = [- 6.49, - 1.05]) over 24 months.","[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, FL, 33146, USA. axm2508@miami.edu.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Lozano', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Tae Kyoung', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Yannine', 'Initials': 'Y', 'LastName': 'Estrada', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, FL, 33146, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Messiah', 'Affiliation': 'University of Texas Health Science Center, Dallas Campus, School of Public Health, Dallas, TX, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Prado', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, FL, 33146, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-021-01220-z']
460,33704378,Safety and Efficacy of Virtual Prostatectomy With Single-Dose Radiotherapy in Patients With Intermediate-Risk Prostate Cancer: Results From the PROSINT Phase 2 Randomized Clinical Trial.,"Importance


Ultra-high single-dose radiotherapy (SDRT) represents a potential alternative to curative extreme hypofractionated stereotactic body radiotherapy (SBRT) in organ-confined prostate cancer.
Objective


To compare toxic effect profiles, prostate-specific antigen (PSA) responses, and quality-of-life end points of SDRT vs extreme hypofractionated SBRT.
Design, Setting, and Participants


The PROSINT single-institution phase 2 randomized clinical trial accrued, between September 2015 and January 2017, 30 participants with intermediate-risk prostate cancer to receive SDRT or extreme hypofractionated SBRT. Androgen deprivation therapy was not permitted. Data were analyzed from March to May 2020.
Interventions


Patients were randomized in a 1:1 ratio to receive 5 × 9 Gy SBRT (control arm) or 24 Gy SDRT (test arm).
Main Outcomes and Measures


The primary end point was toxic effects; the secondary end points were PSA response, PSA relapse-free survival, and patient-reported quality of life measured with the International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaires.
Results


A total of 30 men were randomized; median (interquartile range) age was 66.3 (61.2-69.9) and 73.6 (64.7-75.9) years for the SBRT and SDRT arms, respectively. Time to appearance and duration of acute and late toxic effects were similar in the 2 trial arms. Cumulative late actuarial urinary toxic effects did not differ for grade 1 (hazard ratio [HR], 0.41; 90% CI, 0.13-1.27) and grade 2 or greater (HR, 1.07; 90% CI, 0.21-5.57). Actuarial grade 1 late gastrointestinal (GI) toxic effects were comparable (HR, 0.37; 90% CI, 0.07-1.94) and there were no grade 2 or greater late GI toxic effects. Declines in PSA level to less than 0.5 ng/mL occurred by 36 months in both study arms. No PSA relapses occurred in favorable intermediate-risk disease, while in the unfavorable category, the actuarial 4-year PSA relapse-free survival values were 75.0% vs 64.0% (HR, 0.76; 90% CI, 0.17-3.31) for SBRT vs SDRT, respectively. The EPIC-26 median summary scores for the genitourinary and GI domains dropped transiently at 1 month and returned to pretreatment scores by 3 months in both arms. The IPSS-derived transient late urinary flare symptoms occurred at 9 to 18 months in 20% (90% CI, 3%-37%) of patients receiving SDRT.
Conclusions and Relevance


In this randomized clinical trial among patients with intermediate-risk prostate cancer, SDRT was safe and associated with low toxicity, and the tumor control and quality-of-life end points closely match the SBRT arm outcomes. Further studies are encouraged to explore indications for SDRT in the cure of prostate cancer.
Trial Registration


ClinicalTrials.gov Identifier: NCT02570919.",2021,"In this randomized clinical trial among patients with intermediate-risk prostate cancer, SDRT was safe and associated with low toxicity, and the tumor control and quality-of-life end points closely match the SBRT arm outcomes.","['Patients With Intermediate-Risk Prostate Cancer', 'Participants\n\n\nThe PROSINT single-institution phase 2 randomized clinical trial accrued, between September 2015 and January 2017, 30 participants with intermediate-risk prostate cancer to receive', 'A total of 30 men were randomized; median (interquartile range) age was 66.3 (61.2-69.9) and 73.6 (64.7-75.9) years for the SBRT and SDRT arms, respectively', 'patients with intermediate-risk prostate cancer']","['Importance\n\n\nUltra-high single-dose radiotherapy (SDRT', 'Androgen deprivation therapy', 'SDRT vs extreme hypofractionated SBRT', 'hypofractionated stereotactic body radiotherapy (SBRT', '5\u2009×\u20099 Gy SBRT (control arm) or 24 Gy SDRT', 'Virtual Prostatectomy With Single-Dose Radiotherapy', 'SDRT or extreme hypofractionated SBRT']","['EPIC-26 median summary scores for the genitourinary and GI domains', 'toxic effect profiles, prostate-specific antigen (PSA) responses, and quality-of-life', 'Cumulative late actuarial urinary toxic effects', 'PSA level', 'Safety and Efficacy', 'toxic effects', 'actuarial 4-year PSA relapse-free survival values', 'late GI toxic effects', 'Actuarial grade 1 late gastrointestinal (GI) toxic effects', 'Time to appearance and duration of acute and late toxic effects', 'PSA response, PSA relapse-free survival, and patient-reported quality of life measured with the International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaires', 'PSA relapses', 'IPSS-derived transient late urinary flare symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517833', 'cui_str': '61.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}]","[{'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",30.0,0.371541,"In this randomized clinical trial among patients with intermediate-risk prostate cancer, SDRT was safe and associated with low toxicity, and the tumor control and quality-of-life end points closely match the SBRT arm outcomes.","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Greco', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Pares', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Pimentel', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Vasco', 'Initials': 'V', 'LastName': 'Louro', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Santiago', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Vieira', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Joep', 'Initials': 'J', 'LastName': 'Stroom', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Mateus', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Soares', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Marques', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Elda', 'Initials': 'E', 'LastName': 'Freitas', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Graça', 'Initials': 'G', 'LastName': 'Coelho', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Seixas', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lopez-Beltran', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Zvi', 'Initials': 'Z', 'LastName': 'Fuks', 'Affiliation': 'The Champalimaud Centre for the Unknown, Lisbon, Portugal.'}]",JAMA oncology,['10.1001/jamaoncol.2021.0039']
461,33715993,Health care costs related to home spirometry in the eICE randomized trial.,"BACKGROUND


Home spirometry with regular symptom assessment is one strategy to track lung health to intervene early in episodes of pulmonary exacerbations (PE). In a multi-center randomized controlled trial home spirometry and symptom tracking demonstrated no significant differences regarding the primary clinical endpoint, FEV 1 , compared to usual care, but did identify differences in healthcare utilization. We used data from the Early Intervention in Cystic Fibrosis Exacerbation (eICE) study to evaluate whether home monitoring of PE is a cost-minimizing intervention in the context of this randomized trial.
METHODS


We reviewed healthcare resource utilization of all 267 eICE participants, including outpatient visits, antibiotics and hospitalizations. Prices were identified in the IBM/Watson MarketScan Ⓡ  Commercial Claims and Encounters Databases and averaged over the 2014-2017 period. Using total healthcare utilization costs, we generated summary statistics by intervention and protocol arm (total cost, mean cost, standard deviation). We performed Welch Two Sample t-tests to determine if total costs and cost by type of utilization differed significantly between groups.
RESULTS


Outpatient visit costs were significantly higher by 13% in the Early Intervention (EI) than in the usual care (UC) arm ($3,345 vs. $2,966). We found no significant differences in outpatient antibiotic, hospitalization, or total health care costs between the arms.
CONCLUSIONS


Within the context of the eICE trial, outpatient visits were significantly higher in those with experimental home spirometry care, but that did not translate into statistically significant differences of overall health care costs between the two arms.",2022,"Outpatient visit costs were significantly higher by 13% in the Early Intervention (EI) than in the usual care (UC) arm ($3,345 vs. $2,966).","['267 eICE participants, including outpatient visits, antibiotics and hospitalizations', 'Cystic Fibrosis Exacerbation (eICE']",[],"['total cost, mean cost, standard deviation', 'Outpatient visit costs', 'outpatient antibiotic, hospitalization, or total health care costs', 'overall health care costs', 'total costs and cost by type of utilization']","[{'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0397045,"Outpatient visit costs were significantly higher by 13% in the Early Intervention (EI) than in the usual care (UC) arm ($3,345 vs. $2,966).","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Franz', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, Washington, United States.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Rapp', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, Washington, United States.'}, {'ForeName': 'Ryan N', 'Initials': 'RN', 'LastName': 'Hansen', 'Affiliation': 'School of Pharmacy, University of Washington, Seattle, Washington, United States.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Gold', 'Affiliation': 'Department of Radiology, University of Washington, Seattle, Washington, United States.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Goss', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, United States; Department of Pediatrics, University of Washington, Seattle, Washington, United States.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Lechtzin', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, Maryland, United States.'}, {'ForeName': 'Larry G', 'Initials': 'LG', 'LastName': 'Kessler', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, Washington, United States. Electronic address: kesslerl@uw.edu.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2021.02.014']
462,33713826,Double Blind Pilot Randomized Trial Comparing Extended Anticoagulation to Placebo Following Major Lung Resection for Cancer.,"Venous thromboembolism (VTE), which comprises pulmonary embolus (PE) and deep vein thrombosis (DVT), is a significant cause of postoperative morbidity and mortality. This pilot randomized control trial (RCT) evaluated the feasibility of a full-scale RCT investigating extended thromboprophylaxis in patients undergoing oncological lung resections. Patients undergoing oncological lung resections in 2 tertiary centers received in-hospital, thromboprophylaxis and were randomized to receive post-discharge low-molecular-weight heparin (LMWH) or placebo injections once-daily for 30 days. At 30 days postoperatively, all patients underwent chest computed tomography with PE protocol and bilateral leg venous ultrasound. Primary outcomes included feasibility and safety; VTE incidence and 90-day survival were secondary outcomes. Between December 2015 and June 2018, 619 patients were screened, of whom 62.7% (165/263) of eligible patients consented to participate, and 133 (81%) were randomized. One-hundred and 3 patients, (77.4%), completed the 90-day study follow-up. Reasons for non-participation pre-randomization included patient discomfort and LMWH/placebo administration challenges. Post-randomization withdrawals were due to patient preference, surgeon preference and minor adverse events. Six asymptomatic VTE events (5 PE and 1 DVT) were detected within 30 days (3 in each group), for an overall incidence of 7%. There were 3 minor and no major adverse events. This study is the first to demonstrate the feasibility and safety of a full-scale extended thromboprophylaxis RCT in thoracic surgical oncology. Our results demonstrate that, while recruitment and retention rates were modest, the study design is feasible and with minimal adverse events and no intervention-related mortality.",2021,"Six asymptomatic VTE events (5 PE and 1 DVT) were detected within 30 days (3 in each group), for an overall incidence of 7%.","['One-hundred and three patients, (77.4%), completed the 90-day study follow-up', 'patients undergoing oncological lung resections', 'Patients undergoing oncological lung resections in two tertiary centers received in-hospital, thromboprophylaxis', 'Between December 2015 and June 2018, 619 patients were screened, of whom 62.7% (165/263) of eligible patients consented to participate, and 133 (81%) were randomized', 'major lung resection for cancer']","['post-discharge low-molecular-weight heparin (LMWH) or placebo injections', 'placebo', 'full-scale RCT investigating extended thromboprophylaxis', 'chest computed tomography with PE protocol and bilateral leg venous ultrasound']","['Six asymptomatic VTE events', 'Venous Thromboembolism (VTE), which comprises pulmonary embolus (PE) and deep vein thrombosis (DVT', 'patient preference, surgeon preference and minor adverse events', 'feasibility and safety; VTE incidence and 90-day survival']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",619.0,0.202147,"Six asymptomatic VTE events (5 PE and 1 DVT) were detected within 30 days (3 in each group), for an overall incidence of 7%.","[{'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Shargall', 'Affiliation': ""Division of Thoracic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Division of Thoracic Surgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada; Division of Thoracic Surgery, St. Joseph's Healthcare Hamilton, Firestone Institute for Respiratory Health, Hamilton, Ontario, Canada. Electronic address: shargal@mcmaster.ca.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lori-Ann', 'Initials': 'LA', 'LastName': 'Linkins', 'Affiliation': 'Division of Hematology and Thromboembolism, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Crowther', 'Affiliation': 'Division of Hematology and Thromboembolism, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Farrokhyar', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Waddell', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'de Perrot', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Douketis', 'Affiliation': ""Division of Hematology and Thromboembolism, Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Division of Thoracic Surgery, St. Joseph's Healthcare Hamilton, Firestone Institute for Respiratory Health, Hamilton, Ontario, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Yessica', 'Initials': 'Y', 'LastName': 'Lopez-Hernandez', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Schnurr', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Haider', 'Affiliation': 'Department of Radiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Agzarian', 'Affiliation': ""Division of Thoracic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Division of Thoracic Surgery, St. Joseph's Healthcare Hamilton, Firestone Institute for Respiratory Health, Hamilton, Ontario, Canada.""}, {'ForeName': 'Waël C', 'Initials': 'WC', 'LastName': 'Hanna', 'Affiliation': ""Division of Thoracic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Division of Thoracic Surgery, St. Joseph's Healthcare Hamilton, Firestone Institute for Respiratory Health, Hamilton, Ontario, Canada.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Finley', 'Affiliation': ""Division of Thoracic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Division of Thoracic Surgery, St. Joseph's Healthcare Hamilton, Firestone Institute for Respiratory Health, Hamilton, Ontario, Canada.""}]",Seminars in thoracic and cardiovascular surgery,['10.1053/j.semtcvs.2021.02.032']
463,33691344,Clarithromycin versus furazolidone for naïve Helicobacter pylori infected patients in a high clarithromycin resistance area.,"BACKGROUND AND AIM


The increase in antibiotic resistance makes the eradication of Helicobacter pylori more difficult. Considering the limitations of the application of susceptibility-guided therapy, it is important to find an effective empirical regimen. The aim of the study is to compare the efficacy, safety, and cost-effectiveness of clarithromycin-based bismuth-containing quadruple therapy (C-BQT) and furazolidone-based bismuth-containing quadruple therapy (F-BQT) in naïve H. pylori positive patients.
METHODS


This was an open-label, randomized controlled, crossover trial. The trial comprised two phases. In C-F group, patients received C-BQT in the first phase; those who were still positive for H. pylori infection after the first phase entered the second phase to receive F-BQT as rescue treatment. In F-C group, patients were treated with F-BQT firstly and rescued with C-BQT.
RESULTS


As first-line treatments, the eradication rates of C-BQT and F-BQT were 89.7% (157/175) and 92.0% (161/175) (P = 0.458) in intention-to-treat analysis and 93.4% (156/167) and 95.8% (161/168) (P = 0.327) in per-protocol analysis, respectively. The cumulative eradication rates of the C-F group and the F-C group were both 94.3% in intention-to-treat analysis (P = 1.000). Cost-effectiveness indexes of F-BQT and C-BQT were 0.54 and 1.24 in first-line treatments. Frequencies of adverse events in F-BQT and C-BQT had no differences (36.0% in C-BQT vs 32.6% in F-BQT, P = 0.499).
CONCLUSIONS


Furazolidone-based bismuth-containing quadruple therapy should be preferred for its excellent cost-effectiveness and acceptable safety.",2021,"Frequencies of adverse events in F-BQT and C-BQT had no differences (36.0% in C-BQT vs 32.6% in F-BQT, P = 0.499).
","['naïve Helicobacter pylori infected patients in a high clarithromycin resistance area', 'naïve H.\xa0pylori positive patients']","['furazolidone', 'C-BQT', 'Clarithromycin', 'Furazolidone-based bismuth-containing quadruple therapy', 'clarithromycin-based bismuth-containing quadruple therapy (C-BQT) and furazolidone-based bismuth-containing quadruple therapy (F-BQT']","['Cost-effectiveness indexes of F-BQT and C-BQT', 'cumulative eradication rates', 'eradication rates of C-BQT and F-BQT', 'Frequencies of adverse events', 'efficacy, safety, and cost-effectiveness']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0016855', 'cui_str': 'Furazolidone'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016855', 'cui_str': 'Furazolidone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0871771,"Frequencies of adverse events in F-BQT and C-BQT had no differences (36.0% in C-BQT vs 32.6% in F-BQT, P = 0.499).
","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Qiao', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Yueyue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Chaoran', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Junyan', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Junnan', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ji', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wan', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Boshen', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Minjuan', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Qi', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15468']
464,33713213,Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial.,"We evaluated the acceptability of the 25 mg dapivirine vaginal ring (DVR) as an HIV prevention intervention and its influence on DVR adherence in the MTN-020/ASPIRE phase III trial. Acceptability measures were captured using ACASI at month 3 and end of product use (median 24 months, IQR 15-30). Monthly returned rings were classified as nonadherent if dapivirine release rate was ≤ 0.9 mg/month. Associations between acceptability measures and nonadherence were estimated using Poisson regression models with robust standard errors. At month 3 (N = 2334), 88% reported DVR was comfortable, 80% were unaware of it during daily activities, and 74% never felt it during sex. At exit, 66% were 'very likely' to use DVR in the future. Acceptability was found to differ significantly by country across several measures including wearing the ring during sex, during menses, partner acceptability, impact on sexual pleasure and willingness to use the ring in the future. Risk of nonadherence at month 12 was elevated if DVR was felt during sex at month 3 (aRR 1.67, 95% CI 1.26, 2.23). Risk of nonadherence in the last year of study participation was elevated if, at exit, participants minded wearing during sex (aRR 2.08, 95% CI 1.52, 2.85), during menses (aRR 1.57, 95% CI 1.06, 2.32), reported a problematic change to the vaginal environment (aRR 1.57, 95% CI 1.12, 2.21), and were not ""very likely"" to use DVR in the future (aRR 1.31, 95% CI 1.02, 1.68). DVR acceptability was overall high yet varied by country. Addressing perceived ring interference with sex, menses, or problematic changes to the vaginal environment in future interventions could help improve adherence, as could embracing sex-positive messaging related to ring use and increased pleasure.Trial Registration ClinicalTrials.gov Identifier: NCT01617096.",2021,"Acceptability was found to differ significantly by country across several measures including wearing the ring during sex, during menses, partner acceptability, impact on sexual pleasure and willingness to use the ring in the future.",[],"['Dapivirine Vaginal Ring', 'dapivirine vaginal ring (DVR']","['sexual pleasure and willingness to use the ring in the future', 'DVR acceptability', 'Acceptability measures', 'Risk of nonadherence', 'problematic change to the vaginal environment', 'Acceptability', 'DVR adherence', 'DVR']",[],"[{'cui': 'C1434916', 'cui_str': 'dapivirine'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C1434916', 'cui_str': 'dapivirine'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",66.0,0.0972898,"Acceptability was found to differ significantly by country across several measures including wearing the ring during sex, during menses, partner acceptability, impact on sexual pleasure and willingness to use the ring in the future.","[{'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Mayo', 'Affiliation': ', FHI 360, Durham, NC, USA. amayo@fhi360.org.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Browne', 'Affiliation': ""Women's Global Health Imperative, RTI International, Berkeley, CA, USA.""}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Montgomery', 'Affiliation': ""Women's Global Health Imperative, RTI International, Berkeley, CA, USA.""}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Torjesen', 'Affiliation': ', FHI 360, Durham, NC, USA.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nitesha', 'Initials': 'N', 'LastName': 'Jeenarain', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Linly', 'Initials': 'L', 'LastName': 'Seyama', 'Affiliation': 'College of Medicine-Johns Hopkins Research Project, Queen Elizabeth Central Hospital, Blantyre, Malawi.'}, {'ForeName': 'Kubashni', 'Initials': 'K', 'LastName': 'Woeber', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Ishana', 'Initials': 'I', 'LastName': 'Harkoo', 'Affiliation': 'Centre for AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Krishnaveni', 'Initials': 'K', 'LastName': 'Reddy', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Tchangani', 'Initials': 'T', 'LastName': 'Tembo', 'Affiliation': 'University of North Carolina Project, Lilongwe, Malawi.'}, {'ForeName': 'Prisca', 'Initials': 'P', 'LastName': 'Mutero', 'Affiliation': 'University of Zimbabwe Clinical Trials Research Centre (UZ-CTRC), Harare, Zimbabwe.'}, {'ForeName': 'Thelma', 'Initials': 'T', 'LastName': 'Tauya', 'Affiliation': 'University of Zimbabwe Clinical Trials Research Centre (UZ-CTRC), Harare, Zimbabwe.'}, {'ForeName': 'Miria', 'Initials': 'M', 'LastName': 'Chitukuta', 'Affiliation': 'University of Zimbabwe Clinical Trials Research Centre (UZ-CTRC), Harare, Zimbabwe.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Gati Mirembe', 'Affiliation': 'Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration CRS, Kampala, Uganda.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Soto-Torres', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Brown', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ""Women's Global Health Imperative, RTI International, Berkeley, CA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-021-03205-z']
465,33719899,Mindfulness-Based Stress Reduction in Older Adults at Risk for Coronary Artery Disease: A Pilot Randomized Trial.,"OBJECTIVES


Stress influences metabolic activity and increases risk for cardiovascular disease (CVD). We sought to a) examine feasibility and acceptability of mindfulness-based stress reduction (MBSR) in older adults at risk for CVD, and b) obtain preliminary data on its metabolic impact.
METHODS


A pilot RCT was conducted using a pre-post, 2-month follow-up design. Eighty-one individuals with metabolic syndrome and non-normative responses to stress in a previous investigation were invited. Participants were randomized (by sex and stress response) to a 9-week MBSR or a wait-list control group. Feasibility and acceptability were assessed and blood assayed. Between-subjects (MBSR vs waitlist control) ANOVAs on metabolic parameter change scores, and one-way repeated measures ANOVAs (pre-, post-, follow-up) were performed.
RESULTS


Thirty-three individuals (41%) responded to invitations, 26 were interested, of whom 19 were randomized (M age  = 67 years,  SD  = 7.70). Completion rate of MBSR was 72% and overall attendance was 96%. Reported benefits included increased relaxation, greater interpersonal connection, and increased body awareness. MBSR led to a decrease of 15% in LDL cholesterol and 10% in total cholesterol versus 4.5% and 1%, respectively, in the waitlist. Within group analyses showed notable decreases in LDL, triglycerides, and waist circumference post-MBSR and 2 months later.
CONCLUSIONS


A RCT was largely feasible and MBSR acceptable to participants. MBSR may lead to sustained decreases in cholesterol levels, warranting development of large-scale research on this topic.
CLINICAL IMPLICATIONS


Given the role of stress in CVD, addition of stress management interventions may serve as a useful complement to risk management among older individuals.",2022,"MBSR led to a decrease of 15% in LDL cholesterol and 10% in total cholesterol versus 4.5% and 1%, respectively, in the waitlist.","['Eighty-one individuals with metabolic syndrome and non-normative responses to stress in a previous investigation were invited', 'Older Adults at Risk for Coronary Artery Disease', 'Thirty-three individuals (41%) responded to invitations, 26 were interested, of whom 19 were randomized (M age \xa0=\xa067\xa0years', 'older individuals', 'older adults at risk for CVD, and b']","['Mindfulness-Based Stress Reduction', 'mindfulness-based stress reduction (MBSR', 'MBSR', 'MBSR or a wait-list control group']","['LDL, triglycerides, and waist circumference post-MBSR and 2\xa0months later', 'relaxation, greater interpersonal connection, and increased body awareness', 'cardiovascular disease (CVD', 'Completion rate of MBSR', 'total cholesterol', 'overall attendance', 'Feasibility and acceptability', 'cholesterol levels', 'LDL cholesterol']","[{'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",81.0,0.0230812,"MBSR led to a decrease of 15% in LDL cholesterol and 10% in total cholesterol versus 4.5% and 1%, respectively, in the waitlist.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Gentile', 'Affiliation': 'Research Centre, Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Louisia', 'Initials': 'L', 'LastName': 'Starnino', 'Affiliation': 'Research Centre, Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Dupuis', 'Affiliation': 'Psychology Department, Université du Québec à Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': ""D'Antono"", 'Affiliation': 'Research Centre, Montreal Heart Institute, Montreal, Quebec, Canada.'}]",Clinical gerontologist,['10.1080/07317115.2021.1887421']
466,33719795,Examining Patient Feedback and the Role of Cognitive Arousal in Treatment Non-response to Digital Cognitive-behavioral Therapy for Insomnia during Pregnancy.,"OBJECTIVE


Insomnia affects over half of pregnant and postpartum women. Early evidence indicates that cognitive-behavioral therapy for insomnia (CBTI) improves maternal sleep and mood. However, standard CBTI may be less efficacious in perinatal women than the broader insomnia population. This study sought to identify patient characteristics in a perinatal sample associated with poor response to CBTI, and characterize patient feedback to identify areas of insomnia therapy to tailor for the perinatal experience.
PARTICIPANTS


Secondary analysis of 46 pregnant women with insomnia symptoms who were treated with digital CBTI in a randomized controlled trial.
METHODS


We assessed insomnia, cognitive arousal, and depression before and after prenatal treatment, then 6 weeks postpartum. Patients provided feedback on digital CBTI.
RESULTS


Residual cognitive arousal  after treatment  was the most robust factor associated with treatment non-response. Critically, CBTI responders and non-responders differed on no other sociodemographic or pretreatment metrics. After childbirth, short sleep (<6 hrs/night) was associated with maternal reports of poor infant sleep quality. Patient feedback indicated that most patients preferred online treatment to in-person treatment. Although women described digital CBTI as convenient and helpful, many patients indicated that insomnia therapy would be improved if it addressed sleep challenges unique to pregnancy and postpartum. Patients requested education on maternal and infant sleep, flexibility in behavioral sleep strategies, and guidance to manage infant sleep.
CONCLUSIONS


Modifying insomnia therapy to better alleviate refractory cognitive arousal and address the changing needs of women as they progress through pregnancy and early parenting may increase efficacy for perinatal insomnia.Name: Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum DepressionURL: clinicaltrials.govRegistration: NCT03596879.",2022,"After childbirth, short sleep (<6 hrs/night) was associated with maternal reports of poor infant sleep quality.","['Insomnia during Pregnancy', '46 pregnant women with insomnia symptoms who were treated with', 'Participants ', 'pregnant and postpartum women']","['standard CBTI', 'digital CBTI', 'cognitive-behavioral therapy', 'Digital Cognitive-behavioral Therapy']","['Insomnia and Rumination', 'maternal sleep and mood', 'maternal reports of poor infant sleep quality', 'Residual cognitive arousal', 'insomnia, cognitive arousal, and depression', 'feedback on digital CBTI']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",46.0,0.0500376,"After childbirth, short sleep (<6 hrs/night) was associated with maternal reports of poor infant sleep quality.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Division of Sleep Medicine, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Division of Sleep Medicine, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Division of Sleep Medicine, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Swanson', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Division of Sleep Medicine, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Roth', 'Affiliation': 'Thriving Minds Behavioral Health, Brighton, Michigan.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Division of Sleep Medicine, Henry Ford Health System, Detroit, Michigan.'}]",Behavioral sleep medicine,['10.1080/15402002.2021.1895793']
467,33705531,Rosuvastatin for the prevention of venous thromboembolism: a pooled analysis of the HOPE-3 and JUPITER randomized controlled trials.,"AIMS


To examine the association between rosuvastatin and VTE risk, and whether effects vary in different subpopulations stratified by key demographic, cardiovascular disease (CVD) risk factors, and other risk factors associated with VTE.
METHODS AND RESULTS


An individual participant data meta-analysis was conducted across two randomized controlled trials in 30 507 participants over a mean follow-up of 3.62 years, individuals had no prior history of vascular disease but were at intermediate CV risk. In both trials, participants were randomized to receive rosuvastatin or matching placebo. The primary outcome was VTE during follow-up, defined as either deep vein thrombosis or pulmonary embolism. Associations between rosuvastatin and VTE were examined in the overall pooled cohort, and subpopulations stratified by demographic risk factors (i.e. age and sex), CVD risk factors (i.e. obesity, smoking, lipid levels, blood pressure levels, and C-reactive protein level), and a history of cancer. Mean age was 65.96 (SD 7.19) years of age, and 17 832 (58.45%) were male and 5434 (17.82%) were smokers, median BMI was 27.6 [interquartile range (IQR) 24.7-31.1] kg/m2, and median CRP level was 3.4 (IQR 2.1-6.0) mg/L. There were 139 VTE events. In the pooled cohort, rosuvastatin was associated with a large proportional reduction in the risk of VTE (hazard ratio 0.53, 95% CI 0.37-0.75). No significant interactions were observed between treatment with rosuvastatin and the risk of VTE across subpopulations stratified by demographic, CVD risk factors, or a history of cancer (P-values for interactions >0.05 for all subgroups).
CONCLUSION


Rosuvastatin is associated with a 47% proportional reduction in the risk of VTE, and its effect is consistent both in the presence or absence of VTE-related clinical risk factors.",2022,"No significant interactions were observed between treatment with rosuvastatin and the risk of VTE across subpopulations stratified by demographic, CVD risk factors or a history of cancer (p-values for interactions >0.05 for all subgroups).
","['30,507 participants over a mean follow up of 3.62 years, Individuals had no prior history of vascular disease but were at intermediate CV risk', 'Mean age was 65.96 (SD 7.19) years of age, and 17,832 (58.45%) were male']","['Rosuvastatin', 'rosuvastatin and VTE', 'rosuvastatin or matching placebo', 'rosuvastatin to placebo, rosuvastatin', 'rosuvastatin']","['venous thromboembolism', 'VTE during follow-up, defined as either deep vein thrombosis or pulmonary embolism', 'CVD risk factors (i.e. obesity, smoking, lipid levels, blood pressure levels, C-reactive protein level), and a history of cancer', 'median BMI', 'median CRP level']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0455471', 'cui_str': 'H/O: malignant neoplasm'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",30507.0,0.211126,"No significant interactions were observed between treatment with rosuvastatin and the risk of VTE across subpopulations stratified by demographic, CVD risk factors or a history of cancer (p-values for interactions >0.05 for all subgroups).
","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Joseph', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, 237 Barton St East, Hamilton, ON L8L 2X2, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Glynn', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Lonn', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, 237 Barton St East, Hamilton, ON L8L 2X2, Canada.'}, {'ForeName': 'Chinthanie', 'Initials': 'C', 'LastName': 'Ramasundarahettige', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, 237 Barton St East, Hamilton, ON L8L 2X2, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Eikelboom', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, 237 Barton St East, Hamilton, ON L8L 2X2, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'MacFadyen', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ridker', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, 237 Barton St East, Hamilton, ON L8L 2X2, Canada.'}]",Cardiovascular research,['10.1093/cvr/cvab078']
468,33706000,Correlation between great saphenous length of treatment zone and diameter with improvement in symptoms after ablation.,"OBJECTIVE


The aim of the present study was to examine the relationship between the great saphenous vein (GSV) length of segment ablated and diameter with symptom improvement.
METHODS


Data from a multicenter, randomized, controlled prospective study of 242 patients undergoing radiofrequency ablation (RFA) or cyanoacrylate closure (CAC) of the GSV were analyzed. The venous clinical severity score (VCSS) was measured at baseline and at 1, 3, 6, 12, 24, and 36 months after ablation. The GSV diameter was evaluated for a correlation with VCSS at each time point. Using the median treatment length of 34 cm, the patients were divided into group I (treatment length ≥34 cm) vs group II (<34 cm) for analysis. The pretreatment VCSS and VCSS improvement (ΔVCSS) after treatment were evaluated with respect to the length of the ablated GSV segment. The postablation VCSS was compared between the pretreatment GSV diameters of <5.5 mm vs ≥5.5 mm.
RESULTS


The mean GSV length ablated by RFA was 35.3 ± 14 cm vs 32.6 ± 11 cm with CAC (P = NS). No significant difference was found in the VCSS (at baseline or follow-up) between RFA and CAC. The pooled data for all participants (n = 242) demonstrated a correlation between the treated GSV length and pretreatment VCSS and the ΔVCSS at 36 months (R = 0.23; P < .001). Greater VCSS improvement was seen in group I (≥34 cm ablated) than in group II (<34 cm ablated) at ≤36 months of follow-up (P = .003). At baseline, group I had had higher VCSSs (6.21 ± 2.75 vs 4.88 ± 2.33; P < .00001) and CEAP (clinical, etiologic, anatomic, pathophysiologic) and reflux scores. Of the 242 patients, 101 had had a GSV diameter <5.5 mm and 141 had had a GSV diameter of ≥5.5 mm. No significant differences were noted in the VCSSs, either at baseline or at follow-up, between the two groups. Within the study population, a poor correlation was found between the GSV diameter and baseline VCSS (R = -0.004; P = .95) and between the GSV diameter and ΔVCSS for ≤36 months (R = 0.04; P = .55).
CONCLUSIONS


Longer segments of GSV reflux appeared to correlate with symptom severity. We found a small to moderate correlation between the length of GSV segment ablated and symptom improvement. This might reflect the greater severity of symptoms at baseline in patients with longer segments with reflux. We found a poor correlation between the proximal GSV diameter and symptom improvement after ablation.",2021,Greater VCSS score improvement was seen in group I (≥34cm ablated) versus group II (<34cm ablated) at up to 36-months follow-up (p=0.003).,"['patients with longer segments with reflux', '242 patients undergoing']","['VCSS', 'radiofrequency ablation (RFA) or cyanoacrylate closure (CAC']","['Venous Clinical Severity Score (VCSS', 'great saphenous vein (GSV) length of segment ablated and diameter with symptom improvement', 'treated GSV length and pre-treatment VCSS levels', 'VCSS', 'mean GSV length ablated by RFA', 'CEAP and reflux scores', 'GSV diameter and baseline VCSS', 'VCSS score (ΔVCSS', 'Greater VCSS score improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C1532132', 'cui_str': 'Length of segment'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",242.0,0.0246344,Greater VCSS score improvement was seen in group I (≥34cm ablated) versus group II (<34cm ablated) at up to 36-months follow-up (p=0.003).,"[{'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Attaran', 'Affiliation': 'Divisions of Cardiovascular Medicine, Vascular Surgery and Endovascular Therapy, Yale School of Medicine, New Haven, Conn. Electronic address: robert.attaran@yale.edu.'}, {'ForeName': 'Aneil', 'Initials': 'A', 'LastName': 'Bhalla', 'Affiliation': 'Divisions of Cardiovascular Medicine, Vascular Surgery and Endovascular Therapy, Yale School of Medicine, New Haven, Conn.'}, {'ForeName': 'Carlos I', 'Initials': 'CI', 'LastName': 'Mena-Hurtado', 'Affiliation': 'Divisions of Cardiovascular Medicine, Vascular Surgery and Endovascular Therapy, Yale School of Medicine, New Haven, Conn.'}, {'ForeName': 'Cassius I', 'Initials': 'CI', 'LastName': 'Ochoa Chaar', 'Affiliation': 'Divisions of Cardiovascular Medicine, Vascular Surgery and Endovascular Therapy, Yale School of Medicine, New Haven, Conn.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2021.02.013']
469,33709192,"Dexmedetomidine-soaked nasal packing can reduce pain and improve sleep quality after nasal endoscopic surgery: a double-blind, randomized, controlled clinical trial.","STUDY OBJECTIVE


Bilateral endoscopic nasal surgery is usually associated with pain and sleep disturbance. The aim of this study was to evaluate the effects of dexmedetomidine-soaked nasal packing on analgesia and improvement of sleep quality in patients undergoing this surgery.
METHOD


Eighty patients were enrolled and randomly allocated into 4 groups. At the end of surgery, dexmedetomidine-soaked nasal packings were applied to three groups with a dosage of 1 μg kg -1  (D1), 2μg kg -1  (D2), 4 μg kg -1  (D4) and normal saline-soaked nasal packing (NS) was applied to a fourth group. The primary outcome was postoperative pain scores using a visual analog scale (VAS) recorded at six time points: before the surgery (T1); 2 h (T2), 8 h (T3), 24 h (T4), 48 h (T5) after surgery; and at the moment of nasal packing removal (T6). Secondary outcomes were postoperative sleep status evaluated by the Pittsburgh sleep quality index (PSQI) and subjective sleep quality value (SSQV). Factors affecting sleep, hemodynamic changes, and adverse events were also recorded.
RESULTS


Compared with the NS group, dexmedetomidine-soaked nasal packing significantly relieved postoperative pain and improved sleep quality. The effect was similar between D2 and D4, which was greater than in D1. However, D2 was associated with fewer adverse events.
CONCLUSIONS


Dexmedetomidine-soaked nasal packing not only offers effective analgesia but also improves postoperative sleep quality in patients undergoing bilateral endoscopic nasal surgery. Taking effect and adverse events into consideration, a dosage of 2μg kg -1  may be optimal.
TRIAL REGISTRATION


www.chictr.org.cn/index.aspx (ChiCTR1900025692) Retrospectively registered 5 September 2019.",2021,"Compared with the NS group, dexmedetomidine-soaked nasal packing significantly relieved postoperative pain and improved sleep quality.","['Eighty patients', 'patients undergoing this surgery', 'after nasal endoscopic surgery', 'patients undergoing bilateral endoscopic nasal surgery']","['Dexmedetomidine-soaked nasal packing', 'normal saline-soaked nasal packing (NS', 'dexmedetomidine-soaked nasal packing', 'Bilateral endoscopic nasal surgery', 'dexmedetomidine-soaked nasal packings']","['Factors affecting sleep, hemodynamic changes, and adverse events', 'postoperative pain and improved sleep quality', 'pain', 'sleep quality', 'postoperative sleep quality', 'postoperative sleep status evaluated by the Pittsburgh sleep quality index (PSQI) and subjective sleep quality value (SSQV', 'pain and sleep disturbance', 'postoperative pain scores using a visual analog scale (VAS']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0188970', 'cui_str': 'Operation on nose'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0188970', 'cui_str': 'Operation on nose'}]","[{'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",80.0,0.190427,"Compared with the NS group, dexmedetomidine-soaked nasal packing significantly relieved postoperative pain and improved sleep quality.","[{'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Seventh Affiliated Hospital of Sun Yat-sen University, Shen Zhen, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Shuai', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Shantou University Medical College, 57 Changping Road, Shan Tou, 515000, China.'}, {'ForeName': 'Fudan', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'Department of ENT, The First Affiliated Hospital of Shantou University Medical College, Shan Tou, China.'}, {'ForeName': 'Jiamei', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Shantou University Medical College, 57 Changping Road, Shan Tou, 515000, China.'}, {'ForeName': 'Shaohui', 'Initials': 'S', 'LastName': 'Zhuang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Shantou University Medical College, 57 Changping Road, Shan Tou, 515000, China. doctorzsh@163.com.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-021-02342-y']
470,33749362,Implementation Adherence and Perspectives of the Childcare PhysicaL ActivitY (PLAY) Policy: A Process Evaluation.,"The Childcare PhysicaL ActivitY (PLAY) policy was an evidence-informed, eight-item institutional-level policy document targeting children's physical activity, outdoor play, and sedentary time. Nine childcare centers in London, Ontario, participated in this cluster, randomized controlled trial. Early Childhood Educators allocated to the experimental group, from five childcare centers in London, Ontario, implemented the policy for young children (18 months to 4 years) for 8 weeks and documented adherence to each policy item (i.e., dose) in daily logs. Program evaluation surveys ( n  = 21) and interviews ( n  = 10) were completed postintervention to assess Early Childhood Educators' perspectives of feasibility, context, enjoyment, communication between researchers and childcare staff, and likelihood of future implementation. Descriptive statistics were calculated, and thematic analysis was conducted. Adherence to policy items ranged from 16.5% (for delivery of shorter, more frequent outdoor periods) to 85.9% (for delivery of unstructured/child-directed play). Participants reported effective communication between the research team and childcare centers (0 =  not at all effective  to 5 =  very effective; M  = 4.20;  SD  = 0.83) but noted that they were unlikely to continue the implementation of more frequent outdoor periods (0 =  not at all likely  to 5 =  extremely likely; M  = 2.19;  SD  = 1.21). Interview themes included weather as a prominent barrier and the use of verbal prompts as a solution for implementing the policy. As this was a small and short-term intervention, this pilot study offers important insight on larger scale policy interventions aimed at increasing physical activity and minimizing sedentary time among children enrolled in childcare.",2022,"Adherence to policy items ranged from 16.5% (for delivery of shorter, more frequent outdoor periods) to 85.9% (for delivery of unstructured/child-directed play).","['children enrolled in childcare', 'Nine childcare centers in London, Ontario', 'Program evaluation surveys ( n  = 21) and interviews ( n  = 10']",['Childcare PhysicaL ActivitY'],"['effective communication', 'Childcare PhysicaL ActivitY']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0033336', 'cui_str': 'Evaluation, Program'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",10.0,0.0201039,"Adherence to policy items ranged from 16.5% (for delivery of shorter, more frequent outdoor periods) to 85.9% (for delivery of unstructured/child-directed play).","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Szpunar', 'Affiliation': 'Western University, London, Ontario, Canada.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'Western University, London, Ontario, Canada.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Driediger', 'Affiliation': 'Western University, London, Ontario, Canada.'}, {'ForeName': 'Shauna M', 'Initials': 'SM', 'LastName': 'Burke', 'Affiliation': 'Western University, London, Ontario, Canada.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Irwin', 'Affiliation': 'Western University, London, Ontario, Canada.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Shelley', 'Affiliation': 'Western University, London, Ontario, Canada.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Timmons', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Leigh M', 'Initials': 'LM', 'LastName': 'Vanderloo', 'Affiliation': 'Western University, London, Ontario, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Tucker', 'Affiliation': 'Western University, London, Ontario, Canada.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198121996285']
471,33723675,"Relationship between social support, physical symptoms, and depression in women with breast cancer and pain.","PURPOSE


Fatigue and pain are common among women with breast cancer, and often related to depressive symptoms. Social support may influence levels of fatigue, pain interference, and depressive symptoms. We tested a theory-based, structural model examining the relationship between social support (i.e., emotional and instrumental) and depressive symptoms via fatigue and pain interference in women with breast cancer.
METHODS


Women (N = 327) with stages I-III breast cancer were enrolled in a randomized trial investigating a behavioral pain intervention. Measures of social support, fatigue, pain interference, and depressive symptoms were completed at enrollment. Data were analyzed using structural equation modeling to test direct and indirect pathways relating social support, fatigue, pain interference, and depressive symptoms.
RESULTS


Our model evidenced good fit. Significant direct effects emerged linking higher levels of emotional support with lower levels of fatigue (β = -.30), pain interference (β = -.32), and depressive symptoms (β = -.31). More instrumental support was significantly associated with more depressive symptoms (β = .11), but not fatigue or pain interference. Higher levels of fatigue (β = .30) and pain interference (β = .34) were significantly related to higher levels of depressive symptoms. More emotional support related to less depressive symptoms via lower levels of fatigue (β = -.09) and pain interference (β = -.11).
CONCLUSION


Women reporting higher levels of emotional support endorsed fewer depressive symptoms, and that relationship was driven by lower levels of fatigue and pain interference. Our results highlight novel pathways that healthcare professionals can leverage to optimize social support topics in psychosocial interventions targeting breast cancer symptoms. This model should be replicated using longitudinal data.",2021,"More emotional support related to less depressive symptoms via lower levels of fatigue (β = -.09) and pain interference (β = -.11).
","['I-III breast cancer', 'women with breast cancer and pain', 'Women (N = 327) with stages', 'women with breast cancer']",['behavioral pain intervention'],"['fatigue and pain interference', 'fatigue or pain interference', 'pain interference (β = -.32), and depressive symptoms', 'depressive symptoms', 'fatigue, pain interference, and depressive symptoms', 'pain interference', 'social support, fatigue, pain interference, and depressive symptoms', 'Higher levels of fatigue', 'depressive symptoms via fatigue and pain interference']","[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}]",327.0,0.120541,"More emotional support related to less depressive symptoms via lower levels of fatigue (β = -.09) and pain interference (β = -.11).
","[{'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Fisher', 'Affiliation': 'Pain Prevention and Treatment Research Program, Duke University Medical Center, 2200 W. Main Street, Suite 340, Durham, NC, 27705, USA. hannah.fisher@duke.edu.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Winger', 'Affiliation': 'Pain Prevention and Treatment Research Program, Duke University Medical Center, 2200 W. Main Street, Suite 340, Durham, NC, 27705, USA.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Miller', 'Affiliation': 'Pain Prevention and Treatment Research Program, Duke University Medical Center, 2200 W. Main Street, Suite 340, Durham, NC, 27705, USA.'}, {'ForeName': 'Arianna N', 'Initials': 'AN', 'LastName': 'Wright', 'Affiliation': 'Pain Prevention and Treatment Research Program, Duke University Medical Center, 2200 W. Main Street, Suite 340, Durham, NC, 27705, USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Plumb Vilardaga', 'Affiliation': 'Pain Prevention and Treatment Research Program, Duke University Medical Center, 2200 W. Main Street, Suite 340, Durham, NC, 27705, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Majestic', 'Affiliation': 'Pain Prevention and Treatment Research Program, Duke University Medical Center, 2200 W. Main Street, Suite 340, Durham, NC, 27705, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Kelleher', 'Affiliation': 'Pain Prevention and Treatment Research Program, Duke University Medical Center, 2200 W. Main Street, Suite 340, Durham, NC, 27705, USA.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Somers', 'Affiliation': 'Pain Prevention and Treatment Research Program, Duke University Medical Center, 2200 W. Main Street, Suite 340, Durham, NC, 27705, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-021-06136-6']
472,33723491,mHealth Mindfulness Intervention for Women with Moderate-to-Moderately-Severe Antenatal Depressive Symptoms: a Pilot Study Within an Integrated Health Care System.,"Objectives


Traditional mindfulness-based interventions have been shown to reduce depression symptoms in pregnant women, although in-person classes may pose significant accessibility barriers, particularly during the COVID-19 pandemic. Mobile technology offers greater convenience, but little is known regarding the efficacy of self-paced, mobile-delivered (mHealth) mindfulness interventions in this population. This study tested the feasibility and acceptability of offering such an intervention for pregnant women with moderate-to-moderately-severe depression symptoms.
Methods


We conducted a single-arm trial within Kaiser Permanente Northern California (KPNC). Participants were identified through KPNC's universal perinatal depression screening program. Eligible participants included English-speaking pregnant women (<28 weeks of gestation) with moderate-to-moderately-severe depressive symptoms without a regular (<3 times/week) mindfulness/meditation practice. Participants were asked to follow a self-paced, 6-week mindfulness meditation program using a mobile app, Headspace™, 10-20 min/day. Outcome measures included feasibility, acceptability, and patient-reported outcomes (e.g., depression symptoms).
Results


Of the 27 women enrolled, 20 (74%) completed the study. Over half (55%) of participants used the app ≥50% of the days during the 6-week intervention. Responses to the semi-structured interviews indicated that women appreciated the convenience of the intervention and the ability to engage without having to attend classes or arrange childcare. We observed significant improvements in pre-postintervention scores for depression symptoms, perceived stress, sleep disturbance, and mindfulness.
Conclusions


Our study demonstrates the feasibility and acceptability of an mHealth mindfulness intervention for women with moderate-to-moderately-severe antenatal depression symptoms. The preliminary data further suggest that an efficacy trial is warranted.",2021,"We observed significant improvements in pre-postintervention scores for depression symptoms, perceived stress, sleep disturbance, and mindfulness.
","['Eligible participants included English-speaking pregnant women (<28 weeks of gestation) with moderate-to-moderately-severe depressive symptoms without a regular (<3 times/week) mindfulness/meditation practice', 'pregnant women with moderate-to-moderately-severe depression symptoms', 'Women with Moderate-to-Moderately-Severe Antenatal Depressive Symptoms', 'Kaiser Permanente Northern California (KPNC', 'pregnant women', ""Participants were identified through KPNC's universal perinatal depression screening program"", '27 women enrolled, 20 (74%) completed the study', 'women with moderate-to-moderately-severe antenatal depression symptoms']","['mHealth mindfulness intervention', 'mHealth Mindfulness Intervention']","['feasibility, acceptability, and patient-reported outcomes (e.g., depression symptoms', 'depression symptoms', 'pre-postintervention scores for depression symptoms, perceived stress, sleep disturbance, and mindfulness', 'feasibility and acceptability']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4304583', 'cui_str': 'Moderately severe depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",27.0,0.0427185,"We observed significant improvements in pre-postintervention scores for depression symptoms, perceived stress, sleep disturbance, and mindfulness.
","[{'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Kubo', 'Affiliation': 'Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA 94612 USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Aghaee', 'Affiliation': 'Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA 94612 USA.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Kurtovich', 'Affiliation': 'Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA 94612 USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Nkemere', 'Affiliation': 'Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA 94612 USA.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Quesenberry', 'Affiliation': 'Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA 94612 USA.'}, {'ForeName': 'MegAnn K', 'Initials': 'MK', 'LastName': 'McGinnis', 'Affiliation': 'Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA 94612 USA.'}, {'ForeName': 'Lyndsay A', 'Initials': 'LA', 'LastName': 'Avalos', 'Affiliation': 'Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA 94612 USA.'}]",Mindfulness,['10.1007/s12671-021-01606-8']
473,33745107,"Transvenous phrenic nerve stimulation improves central sleep apnea, sleep quality, and quality of life regardless of prior positive airway pressure treatment.","STUDY OBJECTIVE


Positive airway pressure (PAP) therapy for central sleep apnea (CSA) is often poorly tolerated, ineffective, or contraindicated. Transvenous phrenic nerve stimulation (TPNS) offers an alternative, although its impact on previously PAP-treated patients with CSA has not been examined.
METHODS


TPNS responses among PAP-naïve and prior PAP-treated patients from the remedē ®  System Pivotal Trial were assessed. Of 151, 56 (37%) used PAP therapy before enrolling in the trial. Patients were implanted with a TPNS device and randomized to either active or deferred (control) therapy for 6 months before therapy activation. Apnea-hypopnea index (AHI) and patient-reported outcomes (PRO) were assessed at baseline, and 6 and 12 months following active therapy.
RESULTS


Patients had moderate-severe CSA at baseline, which was of greater severity and more symptomatic in the PAP-treated vs. PAP-naïve group (median AHI 52/h vs. 38, central apnea index (CAI) 32/h vs. 18, Epworth Sleepiness Scale 13 vs. 10, fatigue severity scale 5.2 vs. 4.5). Twelve months of TPNS decreased AHI to <20/h and CAI to ≤2/h. Both groups showed reductions in daytime sleepiness and fatigue, improved well-being by patient global assessment, and high therapeutic acceptance with 98% and 94% of PAP-treated and PAP-naïve patients indicating they would undergo the implant again. Stimulation produced discomfort in approximately one-third of patients, yet <5% of prior PAP-treated participants discontinued therapy.
CONCLUSION


Polysomnographic and clinical responses to TPNS were comparable in PAP-naïve and prior PAP-treated CSA patients. TPNS is a viable therapy across a broad spectrum of CSA patients.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT01816776; March 22, 2013.",2021,"Both groups showed reductions in daytime sleepiness and fatigue, improved well-being by patient global assessment, and high therapeutic acceptance with 98% and 94% of PAP-treated and PAP-naïve patients indicating they would undergo the implant again.","['central sleep apnea (CSA', 'TPNS responses among PAP-naïve and prior PAP-treated patients from the remedē ®  System Pivotal Trial were assessed']","['Positive airway pressure (PAP) therapy', 'PAP therapy', 'TPNS device and randomized to either active or deferred (control) therapy', 'Transvenous phrenic nerve stimulation (TPNS', 'TPNS', 'Transvenous phrenic nerve stimulation']","['discomfort', 'Apnea-hypopnea index (AHI) and patient-reported outcomes (PRO', 'moderate-severe CSA', 'central sleep apnea, sleep quality, and quality of life regardless of prior positive airway pressure treatment', 'daytime sleepiness and fatigue, improved well-being by patient global assessment, and high therapeutic acceptance', 'central apnea index']","[{'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0328586,"Both groups showed reductions in daytime sleepiness and fatigue, improved well-being by patient global assessment, and high therapeutic acceptance with 98% and 94% of PAP-treated and PAP-naïve patients indicating they would undergo the implant again.","[{'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Schwartz', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA. aschwar02@gmail.com.'}, {'ForeName': 'Lee R', 'Initials': 'LR', 'LastName': 'Goldberg', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McKane', 'Affiliation': 'Respicardia, Inc., Minnetonka, MN, USA.'}, {'ForeName': 'Timothy I', 'Initials': 'TI', 'LastName': 'Morgenthaler', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-021-02335-x']
474,33723969,Prehabilitation with wearables versus standard of care before major abdominal cancer surgery: a randomised controlled pilot study (trial registration: NCT04047524).,"BACKGROUND


Prehabilitation aims to improve post-operative outcomes by enhancing pre-operative fitness but is labour-intensive. This pilot study aimed to assess the efficacy of a tri-modal prehabilitation programme delivered by smartwatches for improving functional fitness prior to major abdominal cancer surgery.
METHODS


A single-centre, randomised controlled pilot study, in which 22 patients were randomised to: (a) a prehabilitation group (n = 11), comprising of home-based exercise, nutritional, and dietary advice delivered using a wrist-worn smartwatch connected to a smartphone application; or (b) a control group (n = 11) receiving usual care, with patients given a smartwatch as a placebo. Eligible participants had over two weeks until planned surgery. The primary outcome was pre-operative physical activity including 6-min walk test (6MWT) distance, with secondary outcomes including change in body weight and hospital anxiety and depression score (HADS).
RESULTS


Recruitment was 67% of eligible patients, with groups matched for baseline characteristics. The prehabilitation group engaged in more daily minutes of moderate [25.1 min (95% CI 9.79-40.44) vs 13.1 min (95% CI 5.97-20.31), p = 0.063] and vigorous physical activity [36.1 min (95% CI 21.24-50.90) vs 17.5 min (95% CI 5.18-29.73), p = 0.022] compared to controls. They also had significantly greater improvements in 6MWT distance compared to controls [+ 85.6 m (95% CI, + 18.06 to + 153.21) vs + 13.23 m (95% CI - 6.78 to 33.23), p = 0.014]. HADS scores remained unchanged from baseline in both groups.
CONCLUSION


Prehabilitation in the colorectal cancer care setting can be delivered using smartwatches and mobile applications. Furthermore, this study provides early indicative evidence that such technologies can improve functional capacity prior to surgery TRIAL REGISTRATION: NCT04047524.",2022,"They also had significantly greater improvements in 6MWT distance compared to controls [+ 85.6 m (95% CI, + 18.06 to + 153.21) vs + 13.23 m (95% CI - 6.78 to 33.23), p = 0.014].","['before major abdominal cancer surgery', 'Eligible participants had over two weeks until planned surgery', '22 patients']","['prehabilitation group (n\u2009=\u200911), comprising of home-based exercise, nutritional, and dietary advice delivered using a wrist-worn smartwatch connected to a smartphone application; or (b) a control group (n\u2009=\u200911) receiving usual care, with patients given a smartwatch as a placebo', 'Prehabilitation with wearables versus standard of care', 'tri-modal prehabilitation programme']","['6MWT distance', 'HADS scores', 'vigorous physical activity', 'pre-operative physical activity including 6-min walk test (6MWT) distance, with secondary outcomes including change in body weight and hospital anxiety and depression score (HADS']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0153662', 'cui_str': 'Malignant neoplasm of abdomen'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",22.0,0.279144,"They also had significantly greater improvements in 6MWT distance compared to controls [+ 85.6 m (95% CI, + 18.06 to + 153.21) vs + 13.23 m (95% CI - 6.78 to 33.23), p = 0.014].","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Waller', 'Affiliation': 'Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sutton', 'Affiliation': 'Colorectal and Peritoneal Oncology Centre, The Christie NHS Foundation Trust, Manchester, M20 4BX, UK.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Colorectal and Peritoneal Oncology Centre, The Christie NHS Foundation Trust, Manchester, M20 4BX, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Colorectal and Peritoneal Oncology Centre, The Christie NHS Foundation Trust, Manchester, M20 4BX, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Saxton', 'Affiliation': 'Department of Sport, Exercise, and Rehabilitation, Northumbria University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Aziz', 'Affiliation': 'Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK. omer.aziz@manchester.ac.uk.'}]",Surgical endoscopy,['10.1007/s00464-021-08365-6']
475,33742271,Remote training in laparoscopy: a randomized trial comparing home-based self-regulated training to centralized instructor-regulated training.,"BACKGROUND


Simulation-based surgical training (SBST) is key to securing future surgical expertise. Proficiency-based training (PBT) in laparoscopy has shown promising results on skills transfer. However, time constraints and limited possibilities for distributed training constitute barriers to effective PBT. Home-based training may provide a solution to these barriers and may be a feasible alternative to centralized training in times of assembly constraints.
METHODS


We randomly assigned first-year trainees in abdominal surgery, gynecology, and urology to either centralized instructor-regulated training (CIRT) or home-based self-regulated training (HSRT) in laparoscopy. All participants trained on portable box trainers providing feedback on metrics and possibility for video reviewing. Training in both groups was structured as PBT with graded proficiency exercises adopted from the Fundamentals of Laparoscopic Surgery (FLS). The HSRT group trained at home guided by online learning materials, while the CIRT group attended two training sessions in the simulation center with feedback from experienced instructors. Performance tests consisted of hand-eye and bimanual coordination, suture and knot-tying, and FLS exercises. We analyzed passing rates, training time and distribution, and test performances.
RESULTS


Passing rates were 87% and 96% in the CIRT and HSRT group, respectively. HSRT facilitated distributed training and resulted in greater variation in training times. Task times for hand-eye and bimanual coordination were significantly reduced between pretest and posttest in both groups. Trainees maintained their posttest performances at the 6-month retention test. Our analyses revealed no significant inter-group differences in performances at pretest, posttest, or retention test. Performance improvements in the two groups followed similar patterns.
CONCLUSION


CIRT and HSRT in laparoscopy result in comparable performance improvements. HSRT in laparoscopy is a feasible and effective alternative to CIRT when offered inside a supportive instructional design. Further research is needed to clarify trainees' preferences and explore facilitators and barriers to HSRT.",2022,Task times for hand-eye and bimanual coordination were significantly reduced between pretest and posttest in both groups.,['laparoscopy'],"['CIRT and HSRT', 'Simulation-based surgical training (SBST', 'hand-eye and bimanual coordination, suture and knot-tying, and FLS exercises', 'abdominal surgery, gynecology, and urology to either centralized instructor-regulated training (CIRT) or home-based self-regulated training (HSRT) in laparoscopy', 'PBT with graded proficiency exercises adopted from the Fundamentals of Laparoscopic Surgery (FLS', 'home-based self-regulated training to centralized instructor-regulated training', 'Remote training', 'HSRT', 'Proficiency-based training (PBT']","['passing rates, training time and distribution, and test performances', 'Passing rates', 'Task times for hand-eye and bimanual coordination', 'Performance improvements']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0560032', 'cui_str': 'knot'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0205157', 'cui_str': 'Remote'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",,0.00714702,Task times for hand-eye and bimanual coordination were significantly reduced between pretest and posttest in both groups.,"[{'ForeName': 'Sigurd Beier', 'Initials': 'SB', 'LastName': 'Sloth', 'Affiliation': 'Centre for Educational Development, Aarhus University, Aarhus, Denmark. sigurd@au.dk.'}, {'ForeName': 'Rune Dall', 'Initials': 'RD', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Seyer-Hansen', 'Affiliation': 'Department of Obstetrics & Gynecology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mette Krogh', 'Initials': 'MK', 'LastName': 'Christensen', 'Affiliation': 'Centre for Educational Development, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'De Win', 'Affiliation': 'Antwerp Surgical Training, Anatomy and Research Center (ASTARC), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}]",Surgical endoscopy,['10.1007/s00464-021-08429-7']
476,33735832,The Effects of Combined Balance and Complex Training Versus Complex Training Only on Measures of Physical Fitness in Young Female Handball Players.,"PURPOSE


To examine the effects of balance exercises conducted prior to complex training (bCT) versus complex training (CT) only on measures of physical fitness in young female elite handball players.
METHODS


Participants aged 17 years were randomly assigned to bCT (n = 11) or CT (n = 12). The 2 training interventions lasted 8 weeks with 2 sessions per week in replacement of some technical/tactical handball exercises and were matched for total training volume. Before and after training, tests were performed for the evaluation of proxies of muscle power (countermovement jump height, standing long-jump distance, and reactive strength index), muscle strength (back half-squat 1-repetition maximum), dynamic balance (Y-balance test), linear sprint speed (20-m sprint test), and change-of-direction speed (T test).
RESULTS


Two-factor repeated-measures analysis of variance revealed significant group × time interactions for the reactive strength index (d = 0.99, P = .03) and Y-balance test score (d = 1.32, P < .01). Post hoc analysis indicated significant pre-post reactive strength index improvements in CT (d = 0.69, P = .04) only. For the Y-balance test, significant pre-post increases were found in bCT (d = 0.71, P = .04) with no significant changes in CT (d = 0.61, P = .07). In addition, significant main effects of time were observed for half-squat 1-repetition maximum, countermovement jump, standing long jump, and T test performance (d = 1.50 to 3.10, P < .05).
CONCLUSIONS


Both bCT and CT interventions were effective in improving specific measures of physical fitness in young elite female handball players. If the training goal is to improve balance in addition, balance exercises can be conducted within a CT training session and prior to CT exercises.",2021,"CONCLUSIONS


Both bCT and CT interventions were effective in improving specific measures of physical fitness in young elite female handball players.","['Young Female Handball Players', 'Participants aged 17\xa0years', 'young female elite handball players', 'young elite female handball players']","['balance exercises conducted prior to complex training (bCT) versus complex training (CT', 'bCT', 'bCT and CT interventions', 'CT', 'Combined Balance and Complex Training Versus Complex Training']","['reactive strength index', 'Physical Fitness', 'Y-balance test score', 'physical fitness', 'half-squat 1-repetition maximum, countermovement jump, standing long jump, and T test performance', 'proxies of muscle power (countermovement jump height, standing long-jump distance, and reactive strength index), muscle strength (back half-squat 1-repetition maximum), dynamic balance (Y-balance test), linear sprint speed (20-m sprint test), and change-of-direction speed (T test', 'specific measures of physical fitness']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.00637947,"CONCLUSIONS


Both bCT and CT interventions were effective in improving specific measures of physical fitness in young elite female handball players.","[{'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Chaabene', 'Affiliation': ''}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Negra', 'Affiliation': ''}, {'ForeName': 'Senda', 'Initials': 'S', 'LastName': 'Sammoud', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Moran', 'Affiliation': ''}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': ''}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': ''}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Prieske', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0765']
477,33724296,Short-course radiotherapy with consolidation chemotherapy versus conventionally fractionated long-course chemoradiotherapy for locally advanced rectal cancer: randomized clinical trial.,"BACKGROUND


The trial hypothesis was that, in a resource-constrained situation, short-course radiotherapy would improve treatment compliance compared with conventional chemoradiotherapy for locally advanced rectal cancer, without compromising oncological outcomes.
METHODS


In this open-label RCT, patients with cT3, cT4 or node-positive non-metastatic rectal cancer were allocated randomly to 5 × 5 Gy radiotherapy and two cycles of XELOX (arm A) or chemoradiotherapy with concurrent capecitabine (arm B), followed by total mesorectal excision in both arms. All patients received a further six cycles of adjuvant chemotherapy with the XELOX regimen. The primary endpoint was treatment compliance, defined as the ability to complete planned treatment, including neoadjuvant radiochemotherapy, surgery, and adjuvant chemotherapy to a dose of six cycles.
RESULTS


Of 162 allocated patients, 140 were eligible for analysis: 69 in arm A and 71 in arm B. Compliance with planned treatment (primary endpoint) was greater in arm A (63 versus 41 per cent; P = 0.005). The incidence of acute toxicities of neoadjuvant therapy was similar (haematological: 28 versus 32 per cent, P = 0.533; gastrointestinal: 14 versus 21 per cent, P = 0.305; grade III-IV: 2 versus 4 per cent, P = 1.000). Delays in radiotherapy were less common in arm A (9 versus 45 per cent; P < 0.001), and overall times for completion of neoadjuvant treatment were shorter (P < 0.001). The rates of R0 resection (87 versus 90 per cent; P = 0.554), sphincter preservation (32 versus 35 per cent; P = 0.708), pathological complete response (12 versus 10 per cent; P = 0.740), and overall tumour downstaging (75 versus 75 per cent; P = 0.920) were similar. Downstaging of the primary tumour (ypT) was more common in arm A (P = 0.044). There was no difference in postoperative complications between trial arms (P = 0.838).
CONCLUSION


Reduced treatment delays and a higher rate of compliance were observed with treatment for short-course radiotherapy with consolidation chemotherapy, with no difference in early oncological surgical outcomes. In time- and resource-constrained rectal cancer units in developing countries, short-course radiotherapy should be the standard of care.",2021,"Delays in radiotherapy were less common in arm A (9 versus 45 per cent; P < 0.001), and overall times for completion of neoadjuvant treatment were shorter (P < 0.001).","['locally advanced rectal cancer', '162 allocated patients', 'patients with cT3, cT4 or node-positive non-metastatic rectal cancer']","['Short-course radiotherapy with consolidation chemotherapy versus conventionally fractionated long-course chemoradiotherapy', 'conventional chemoradiotherapy', 'Gy radiotherapy and two cycles of XELOX (arm A) or chemoradiotherapy with concurrent capecitabine', 'adjuvant chemotherapy']","['pathological complete response', 'rate of compliance', 'postoperative complications', 'treatment compliance, defined as the ability to complete planned treatment, including neoadjuvant radiochemotherapy, surgery, and adjuvant chemotherapy to a dose of six cycles', 'early oncological surgical outcomes', 'acute toxicities of neoadjuvant therapy', 'sphincter preservation', 'overall tumour downstaging', 'rates of R0 resection']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1175872', 'cui_str': 'CAGE1 protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0346975', 'cui_str': 'Secondary malignant neoplasm of rectum'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",162.0,0.474483,"Delays in radiotherapy were less common in arm A (9 versus 45 per cent; P < 0.001), and overall times for completion of neoadjuvant treatment were shorter (P < 0.001).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Chakrabarti', 'Affiliation': ""Department of Radiation Oncology, King George's Medical University, Lucknow, India.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rajan', 'Affiliation': ""Department of Surgical Oncology, King George's Medical University, Lucknow, India.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Akhtar', 'Affiliation': ""Department of Surgical Oncology, King George's Medical University, Lucknow, India.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Qayoom', 'Affiliation': ""Department of Pathology, King George's Medical University, Lucknow, India.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ""Department of Surgical Oncology, King George's Medical University, Lucknow, India.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Verma', 'Affiliation': ""Department of Radiation Oncology, King George's Medical University, Lucknow, India.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Srivastava', 'Affiliation': ""Department of Radiation Oncology, King George's Medical University, Lucknow, India.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': ""Department of Surgical Oncology, King George's Medical University, Lucknow, India.""}, {'ForeName': 'M L B', 'Initials': 'MLB', 'LastName': 'Bhatt', 'Affiliation': ""Department of Radiation Oncology, King George's Medical University, Lucknow, India.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': ""Department of Radiation Oncology, King George's Medical University, Lucknow, India.""}]",The British journal of surgery,['10.1093/bjs/znab020']
478,33745228,"A pilot feasibility study of an unguided, internet-delivered cognitive behavioral therapy program for irritable bowel syndrome.","BACKGROUND


Irritable bowel syndrome (IBS) is linked with lower health-related quality of life. Cognitive behavioral therapy (CBT) designed for IBS management can improve outcomes but further research of more accessible implementations of this treatment approach for IBS is needed. This study assessed the feasibility of a web-delivered CBT program among adults with IBS to apply to a future clinical trial.
METHODS


Twenty-five participants were randomized to receive an unguided web-based, CBT program for IBS. The primary outcome was changes in IBS symptom severity (IBS Symptom Severity Scale [IBS-SSS]). Secondary outcomes included IBS-specific CBT therapeutic mechanisms of change (GI-specific anxiety, unhelpful IBS behaviors, and GI-focused cognitions) and changes in depressive (Patient Health Questionnaire-9 [PHQ-9]) and anxiety (Generalized Anxiety Disorder-7 scale [GAD-7]) symptom severity.
KEY RESULTS


Among participants randomized to receive web-based CBT, the average baseline IBS-SSS score was 296.3 (SD=100.9). IBS symptom severity significantly improved at 2-month (p < 0.001) and 3-month follow-up (p < 0.0001); the within-group effect size between baseline and 3-month follow-up IBS-SSS scores was large (d = 1.14) and 63.6% experienced a clinically meaningful improvement (ie, ≥50-point IBS-SSS score reduction). GI-specific anxiety symptoms and cognitions significantly improved at 2-month follow-up, as did unhelpful IBS safety behaviors. Additionally, clinically meaningful improvement was observed in depressive and anxiety symptoms at 3-month follow-up among participants with symptoms above the clinical threshold (ie, PHQ-9 ≥ 10 and GAD-7 ≥ 10, respectively) at baseline.
CONCLUSIONS & INFERENCES


These preliminary findings warrant a larger trial to investigate an unguided, web-based CBT for IBS symptom management that is powered to detect between-group treatment effects.",2021,"IBS symptom severity significantly improved at 2-month (p < 0.001) and 3-month follow-up (p < 0.0001); the within-group effect size between baseline and 3-month follow-up IBS-SSS scores was large (d = 1.14) and 63.6% experienced a clinically meaningful improvement (ie, ≥50-point IBS-SSS score reduction).","['Twenty-five participants', 'adults with IBS', 'irritable bowel syndrome']","['unguided, internet-delivered cognitive behavioral therapy program', 'CBT program', 'Cognitive behavioral therapy (CBT', 'unguided web-based, CBT program for IBS']","['IBS symptom severity', 'anxiety (Generalized Anxiety Disorder-7 scale [GAD-7]) symptom severity', 'IBS-specific CBT therapeutic mechanisms of change (GI-specific anxiety, unhelpful IBS behaviors, and GI-focused cognitions) and changes in depressive (Patient Health Questionnaire-9', 'average baseline IBS-SSS score', 'IBS symptom severity (IBS Symptom Severity Scale [IBS-SSS', 'GI-specific anxiety symptoms and cognitions', 'depressive and anxiety symptoms']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",25.0,0.0900536,"IBS symptom severity significantly improved at 2-month (p < 0.001) and 3-month follow-up (p < 0.0001); the within-group effect size between baseline and 3-month follow-up IBS-SSS scores was large (d = 1.14) and 63.6% experienced a clinically meaningful improvement (ie, ≥50-point IBS-SSS score reduction).","[{'ForeName': 'Jocelynn T', 'Initials': 'JT', 'LastName': 'Owusu', 'Affiliation': 'Mahana Therapeutics, Inc, San Francisco, CA, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sibelli', 'Affiliation': 'Mahana Therapeutics, Inc, San Francisco, CA, USA.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""Department of Psychology, King's College London, UK.""}, {'ForeName': 'Miranda A L', 'Initials': 'MAL', 'LastName': 'van Tilburg', 'Affiliation': 'College of Pharmacy & Health Sciences, Campbell University, Buies Creek, NC, USA.'}, {'ForeName': 'Rona L', 'Initials': 'RL', 'LastName': 'Levy', 'Affiliation': 'School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Oser', 'Affiliation': 'Mahana Therapeutics, Inc, San Francisco, CA, USA.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.14108']
479,33737170,Effects of web-based cognitive behavioral stress management and health promotion interventions on neuroendocrine and inflammatory markers in men with advanced prostate cancer: A randomized controlled trial.,"Cognitive behavioral stress management (CBSM) improves quality of life and mitigates stress biology in patients with early-stage cancer, including men with localized prostate cancer. However, treatments for advanced prostate cancer like androgen deprivation therapy (ADT) can lead to significant symptom burden that may be further exacerbated by stress-induced inflammation and cortisol dysregulation. The aim of this study was to examine the effects of CBSM (versus an active health promotion control) on circulating inflammatory markers and cortisol in men with advanced prostate cancer.
METHODS


Men with stage III or IV prostate cancer (N = 192) who had undergone ADT within the last year were randomized to CBSM or health promotion. Both interventions were 10 weeks, group-based, and delivered online. Venous blood was drawn at baseline, 6 months, and 12 months to measure circulating levels of CRP, IL-6, IL-8, IL-10, and TNF-α. Saliva samples were collected at awakening, 30 min after awakening, evening, and night for two consecutive days at baseline, 6-months, and 12-months to measure diurnal cortisol slopes.
RESULTS


Mixed modeling analyses demonstrated that changes in inflammatory markers and cortisol did not differ by intervention. Men in both CBSM and health promotion showed decreases in IL-10, IL-8, and TNF-α from baseline to 6 months (β = -3.85--5.04, p's = 0.004-<0.001). However, these markers generally demonstrated a rebound increase from 6 to 12 months (β = 1.91-4.06, p's = 0.06-<0.001). Men in health promotion also demonstrated a flatter diurnal cortisol slope versus men in CBSM at 6 months (β = -2.27, p = .023), but not at 12 months. There were no intervention effects on CRP, IL-6, or overall cortisol output.
CONCLUSIONS


Contrary to hypotheses, CBSM did not lead to changes in the circulating inflammatory markers and cortisol relative to health promotion. CBSM may be associated with healthy diurnal cortisol rhythm because of its focus on cognitive behavioral approaches to stress management. More research is needed to understand the impact of CBSM and health promotion on biomarkers among men with advanced prostate cancer.",2021,"Men in both CBSM and health promotion showed decreases in IL-10, IL-8, and TNF-α from baseline to 6 months (β=-3.85--5.04, p's=.004-<.001).","['men with advanced prostate cancer', 'advanced prostate cancer like', 'patients with early-stage cancer, including men with localized prostate cancer', 'Men with stage III or IV prostate cancer (N = 192) who had undergone ADT within the last year']","['CBSM', 'androgen deprivation therapy (ADT', 'CBSM or health promotion', 'Cognitive behavioral stress management (CBSM', 'web-based cognitive behavioral stress management and health promotion interventions', 'active health promotion control']","['inflammatory markers and cortisol', 'diurnal cortisol slopes', 'Venous blood', 'IL-10, IL-8, and TNF-α', 'circulating levels of CRP, IL-6, IL-8, IL-10, and TNF-α. Saliva samples', 'CRP, IL-6, or overall cortisol output', 'flatter diurnal cortisol slope', 'quality of life and mitigates stress biology']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005532', 'cui_str': 'Biology'}]",192.0,0.176443,"Men in both CBSM and health promotion showed decreases in IL-10, IL-8, and TNF-α from baseline to 6 months (β=-3.85--5.04, p's=.004-<.001).","[{'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Penedo', 'Affiliation': 'Department of Psychology, University of Miami, United States; Department of Medicine, University of Miami Miller School of Medicine, United States. Electronic address: frank.penedo@miami.edu.'}, {'ForeName': 'Rina S', 'Initials': 'RS', 'LastName': 'Fox', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, United States.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychology, University of Miami, United States.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Yanez', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, United States.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Miller', 'Affiliation': 'Institute for Policy Research and Department of Psychology, Northwestern University, United States.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Oswald', 'Affiliation': 'Health Outcomes and Behavior Program, H. Lee Moffitt Cancer Center & Research Institute, United States.'}, {'ForeName': 'Ryne', 'Initials': 'R', 'LastName': 'Estabrook', 'Affiliation': 'Department of Psychology, University of Illinois at Chicago, United States.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Chatterton', 'Affiliation': 'Department of Obstetrics & Gynecology, Northwestern University Feinberg School of Medicine, United States.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, United States.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Begale', 'Affiliation': 'Vibrent Health, United States.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Flury', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, United States.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Perry', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, United States.'}, {'ForeName': 'Shilajit D', 'Initials': 'SD', 'LastName': 'Kundu', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, United States.'}, {'ForeName': 'Patricia I', 'Initials': 'PI', 'LastName': 'Moreno', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, United States.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2021.03.014']
480,33752941,Post-fundoplication dysphagia: Laparoscopic intervention or endoscopic dilation?,,2021,,['Post-fundoplication dysphagia'],['Laparoscopic intervention or endoscopic dilation'],[],"[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0192499', 'cui_str': 'Esophagogastric fundoplasty'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0393293', 'cui_str': 'Endoscopic dilation'}]",[],,0.0646026,,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Tustumi', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brasil; Hospital Israelita Albert Einstein, São Paulo, Brasil; Centro Universitário Lusíada, São Paulo, Brasil. Electronic address: franciscotustumi@gmail.com.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Nogueira Datrino', 'Affiliation': 'Centro Universitário Lusíada, São Paulo, Brasil.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Andrade Serafim', 'Affiliation': 'Centro Universitário Lusíada, São Paulo, Brasil.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Orlandini', 'Affiliation': 'Centro Universitário Lusíada, São Paulo, Brasil.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Gioia Morrell', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brasil; Centro Universitário Lusíada, São Paulo, Brasil; Instituto Morrell, São Paulo, Brasil.'}]",Revista de gastroenterologia de Mexico (English),['10.1016/j.rgmx.2020.11.003']
481,33752439,High-Sensitivity Cardiac Troponin on Presentation to Rule Out Myocardial Infarction: A Stepped-Wedge Cluster Randomized Controlled Trial.,"BACKGROUND


High-sensitivity cardiac troponin assays enable myocardial infarction to be ruled out earlier, but the safety and efficacy of this approach is uncertain. We investigated whether an early rule-out pathway is safe and effective for patients with suspected acute coronary syndrome.
METHODS


We performed a stepped-wedge cluster randomized controlled trial in the emergency departments of 7 acute care hospitals in Scotland. Consecutive patients presenting with suspected acute coronary syndrome between December 2014 and December 2016 were included. Sites were randomized to implement an early rule-out pathway where myocardial infarction was excluded if high-sensitivity cardiac troponin I concentrations were <5 ng/L at presentation. During a previous validation phase, myocardial infarction was ruled out when troponin concentrations were <99th percentile at 6 to 12 hours after symptom onset. The coprimary outcome was length of stay (efficacy) and myocardial infarction or cardiac death after discharge at 30 days (safety). Patients were followed for 1 year to evaluate safety and other secondary outcomes.
RESULTS


We enrolled 31 492 patients (59±17 years of age [mean±SD]; 45% women) with troponin concentrations <99th percentile at presentation. Length of stay was reduced from 10.1±4.1 to 6.8±3.9 hours (adjusted geometric mean ratio, 0.78 [95% CI, 0.73-0.83];  P <0.001) after implementation and the proportion of patients discharged increased from 50% to 71% (adjusted odds ratio, 1.59 [95% CI, 1.45-1.75]). Noninferiority was not demonstrated for the 30-day safety outcome (upper limit of 1-sided 95% CI for adjusted risk difference, 0.70% [noninferiority margin 0.50%];  P =0.068), but the observed differences favored the early rule-out pathway (0.4% [57/14 700] versus 0.3% [56/16 792]). At 1 year, the safety outcome occurred in 2.7% (396/14 700) and 1.8% (307/16 792) of patients before and after implementation (adjusted odds ratio, 1.02 [95% CI, 0.74-1.40];  P =0.894), and there were no differences in hospital reattendance or all-cause mortality.
CONCLUSIONS


Implementation of an early rule-out pathway for myocardial infarction reduced length of stay and hospital admission. Although noninferiority for the safety outcome was not demonstrated at 30 days, there was no increase in cardiac events at 1 year. Adoption of this pathway would have major benefits for patients and health care providers. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03005158.",2021,"Non-inferiority was not demonstrated for the 30-day safety outcome (upper limit of one-sided 95% CI for adjusted risk difference 0.70%, non-inferiority margin 0.50%, P=0.068), but the observed differences favoured the early rule-out pathway (0.4% [57/14,700] versus 0.3% [56/16,792]).","['Myocardial Infarction', 'Emergency Departments of seven acute care hospitals in Scotland', 'We enrolled 31,492 patients (59±17 years, 45% women) with troponin concentrations <99th centile at presentation', 'Consecutive patients presenting with suspected acute coronary syndrome between December 2014 and December 2016 were included', 'patients with suspected acute coronary syndrome']",['High-Sensitivity Cardiac Troponin'],"['hospital reattendance or all-cause mortality', 'Length of stay', 'proportion of patients discharged', 'safety outcome', 'troponin concentrations', 'length of stay and hospital admission', '30-day safety outcome', 'length of stay (efficacy), and myocardial infarction or cardiac death after discharge at 30 days (safety', 'cardiac events']","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",31492.0,0.497957,"Non-inferiority was not demonstrated for the 30-day safety outcome (upper limit of one-sided 95% CI for adjusted risk difference 0.70%, non-inferiority margin 0.50%, P=0.068), but the observed differences favoured the early rule-out pathway (0.4% [57/14,700] versus 0.3% [56/16,792]).","[{'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.A., K.K.L., A.R.C., A.V.F., P.D.A., F.E.S., K.A.A.F., D.E.N., A.S.V.S., N.L.M.), University of Edinburgh, United Kingdom.s.'}, {'ForeName': 'Kuan Ken', 'Initials': 'KK', 'LastName': 'Lee', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.A., K.K.L., A.R.C., A.V.F., P.D.A., F.E.S., K.A.A.F., D.E.N., A.S.V.S., N.L.M.), University of Edinburgh, United Kingdom.s.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Chapman', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.A., K.K.L., A.R.C., A.V.F., P.D.A., F.E.S., K.A.A.F., D.E.N., A.S.V.S., N.L.M.), University of Edinburgh, United Kingdom.s.'}, {'ForeName': 'Amy V', 'Initials': 'AV', 'LastName': 'Ferry', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.A., K.K.L., A.R.C., A.V.F., P.D.A., F.E.S., K.A.A.F., D.E.N., A.S.V.S., N.L.M.), University of Edinburgh, United Kingdom.s.'}, {'ForeName': 'Phil D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.A., K.K.L., A.R.C., A.V.F., P.D.A., F.E.S., K.A.A.F., D.E.N., A.S.V.S., N.L.M.), University of Edinburgh, United Kingdom.s.'}, {'ForeName': 'Fiona E', 'Initials': 'FE', 'LastName': 'Strachan', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.A., K.K.L., A.R.C., A.V.F., P.D.A., F.E.S., K.A.A.F., D.E.N., A.S.V.S., N.L.M.), University of Edinburgh, United Kingdom.s.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences (C.B.), University of Glasgow, United Kingdom.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Findlay', 'Affiliation': 'Department of Cardiology, Royal Alexandra Hospital, Paisley, United Kingdom (I.F.).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cruikshank', 'Affiliation': 'Department of Biochemistry, Queen Elizabeth University Hospital, Glasgow, United Kingdom (A.C., A.R.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Reid', 'Affiliation': 'Department of Biochemistry, Queen Elizabeth University Hospital, Glasgow, United Kingdom (A.C., A.R.).'}, {'ForeName': 'Paul O', 'Initials': 'PO', 'LastName': 'Collinson', 'Affiliation': ""Departments of Clinical Blood Sciences and Cardiology, St. George's University Hospitals NHS Trust and St. George's University of London, United Kingdom (P.O.C.).""}, {'ForeName': 'Fred S', 'Initials': 'FS', 'LastName': 'Apple', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Hennepin Healthcare & University of Minnesota School of Medicine, Minneapolis (F.S.A.).'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'McAllister', 'Affiliation': 'Institute of Health and Wellbeing (D.A.M.), University of Glasgow, United Kingdom.'}, {'ForeName': 'Donogh', 'Initials': 'D', 'LastName': 'Maguire', 'Affiliation': 'Emergency Medicine Department, Glasgow Royal Infirmary, United Kingdom (D.M.).'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.A., K.K.L., A.R.C., A.V.F., P.D.A., F.E.S., K.A.A.F., D.E.N., A.S.V.S., N.L.M.), University of Edinburgh, United Kingdom.s.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.A., K.K.L., A.R.C., A.V.F., P.D.A., F.E.S., K.A.A.F., D.E.N., A.S.V.S., N.L.M.), University of Edinburgh, United Kingdom.s.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Tuck', 'Affiliation': 'Edinburgh Clinical Trials Unit (C.T., R.H., C.K., C.J.W., R.A.P.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Harkess', 'Affiliation': 'Edinburgh Clinical Trials Unit (C.T., R.H., C.K., C.J.W., R.A.P.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Keerie', 'Affiliation': 'Edinburgh Clinical Trials Unit (C.T., R.H., C.K., C.J.W., R.A.P.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Weir', 'Affiliation': 'Edinburgh Clinical Trials Unit (C.T., R.H., C.K., C.J.W., R.A.P.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Parker', 'Affiliation': 'Edinburgh Clinical Trials Unit (C.T., R.H., C.K., C.J.W., R.A.P.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Alasdair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Usher Institute (A.G., A.S.V.S., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Anoop S V', 'Initials': 'ASV', 'LastName': 'Shah', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.A., K.K.L., A.R.C., A.V.F., P.D.A., F.E.S., K.A.A.F., D.E.N., A.S.V.S., N.L.M.), University of Edinburgh, United Kingdom.s.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.A., K.K.L., A.R.C., A.V.F., P.D.A., F.E.S., K.A.A.F., D.E.N., A.S.V.S., N.L.M.), University of Edinburgh, United Kingdom.s.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.052380']
482,33772435,Keepin' It REAL-Mantente REAL in Mexico: a Cluster Randomized Controlled Trial of a Culturally Adapted Substance Use Prevention Curriculum for Early Adolescents.,"This study assesses the efficacy of a version of the keepin' it REAL (kiREAL) substance use prevention curriculum for middle school students that was culturally adapted for Mexico, renamed Mantente REAL (MREAL), and tested in a cluster randomized controlled trial in Mexico's three largest cities. Student participants were in 7th grade in public middle schools (N = 5523, 49% female, mean age = 11.9). A representative sample of 12 schools from each city, stratified by whether they held morning or afternoon sessions, was randomized to three conditions: culturally adapted MREAL, original kiREAL translated into Spanish, or a treatment-as-usual control group. Regular classroom teachers were trained to deliver the adapted MREAL or the kiREAL manualized curricula. Students with active parental consent completed pretest and post-test questionnaires, 7-8 months apart, at the beginning and end of the 2017-2018 academic year. We assessed the MREAL intervention, relative to kiREAL and controls, with general linear models adjusted for baseline, attrition (24%), non-normal distributions, stratification by city, and school-level clustering. Among students already using the substance more often at pretest, MREAL students had relatively more desirable outcomes, compared to kiREAL and/or to controls, in recent use of alcohol, cigarettes, ""hard drugs,"" heavy episodic drinking, and intoxication. MREAL students reported relatively less violence victimization and perpetration of bullying and relatively more use of three of the intervention's REAL drug resistance strategies (Explain, Avoid, Leave). The adapted version of kiREAL for Mexico showed numerous desired outcomes in areas deliberately targeted in the cultural adaptation. Full protocol can be accessed through Clinical Trials.gov. ID: NCT03233386, ""'Keepin' It REAL in Mexico: An adaptation and multisite RCT"".",2021,"MREAL students reported relatively less violence victimization and perpetration of bullying and relatively more use of three of the intervention's REAL drug resistance strategies (Explain, Avoid, Leave).","['Early Adolescents', 'Regular classroom teachers', 'Mexico', 'middle school students', 'A representative sample of 12 schools from each city, stratified by whether they held morning or afternoon sessions, was randomized to three conditions', 'Student participants were in 7th grade in public middle schools (N\xa0=\xa05523, 49% female, mean age\xa0=\xa011.9']","['culturally adapted MREAL, original kiREAL translated into Spanish, or a treatment-as-usual control group', ""keepin' it REAL (kiREAL) substance use prevention curriculum"", 'ID', 'Keepin']",['violence victimization and perpetration of bullying'],"[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0040710', 'cui_str': 'Translating'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150358', 'cui_str': 'Substance use prevention'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}]",,0.16054,"MREAL students reported relatively less violence victimization and perpetration of bullying and relatively more use of three of the intervention's REAL drug resistance strategies (Explain, Avoid, Leave).","[{'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Kulis', 'Affiliation': 'Global, Center for Applied Health Research, Arizona State University, 411 N. Central Avenue, Suite 720, Phoenix, AZ, 85004-0693, USA. kulis@asu.edu.'}, {'ForeName': 'Flavio F', 'Initials': 'FF', 'LastName': 'Marsiglia', 'Affiliation': 'Global, Center for Applied Health Research, Arizona State University, 411 N. Central Avenue, Suite 720, Phoenix, AZ, 85004-0693, USA.'}, {'ForeName': 'Maria Elena', 'Initials': 'ME', 'LastName': 'Medina-Mora', 'Affiliation': 'Facultad de Psicología, Universidad Nacional Autónoma de México, Avenida Universidad 3000, Circuito Ciudad Universitaria, Coyoacán, CP 04510, Ciudad de Mexico, Mexico.'}, {'ForeName': 'Bertha L', 'Initials': 'BL', 'LastName': 'Nuño-Gutiérrez', 'Affiliation': 'Centro de Estudios e Investigaciones, Universidad de Guadalajara, Francisco de Quevedo, #180 Col. Arcos Vallarta, 44130, Guadalajara, Mexico.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Corona', 'Affiliation': 'Departamento de Enfermerías, Universidad Autónoma de Nuevo León, San Nicolas de la Garza, Mexico.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Ayers', 'Affiliation': 'Global, Center for Applied Health Research, Arizona State University, 411 N. Central Avenue, Suite 720, Phoenix, AZ, 85004-0693, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-021-01217-8']
483,33758387,Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial.,"OBJECTIVE


This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial.
STUDY DESIGN


Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial. Moderate/severe NDI was defined as BSID-III Cognitive or Motor composite score <85, moderate or severe cerebral palsy, blindness, or hearing loss that prevents communication despite amplification were assessed.
RESULTS


Primary outcome was determined for 605/638 (95%). The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40).
CONCLUSIONS


Treatment group did not affect the risk of death or survival with moderate/severe NDI. Despite early termination, this study represents the largest RCT of extremely preterm infants treated with myo-inositol with neurodevelopmental outcome data.",2021,"The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40).
","['Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial', 'preterm infants enrolled in myo-inositol randomized controlled trial']",[],"['mean gestational age', 'BSID-III Cognitive or Motor composite score <85, moderate or severe cerebral palsy, blindness, or hearing loss', 'Moderate/severe NDI', 'risk of death or survival', 'death or survival with moderate/severe NDI']","[{'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C1563705', 'cui_str': 'Diabetes Insipidus, Nephrogenic, Type I'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.283315,"The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40).
","[{'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Adams-Chapman', 'Affiliation': ""Department of Pediatrics, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA.""}, {'ForeName': 'Kristi L', 'Initials': 'KL', 'LastName': 'Watterberg', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Nolen', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Hirsch', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Cole', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Cotten', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Oh', 'Affiliation': ""Department of Pediatrics, Women & Infants' Hospital, Brown University, Providence, RI, USA.""}, {'ForeName': 'Brenda B', 'Initials': 'BB', 'LastName': 'Poindexter', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Zaterka-Baxter', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, MD, USA.'}, {'ForeName': 'Conra Backstrom', 'Initials': 'CB', 'LastName': 'Lacy', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Scorsone', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Andrea F', 'Initials': 'AF', 'LastName': 'Duncan', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'DeMauro', 'Affiliation': ""Department of Pediatrics, The Children's Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Ricki F', 'Initials': 'RF', 'LastName': 'Goldstein', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, USA.'}, {'ForeName': 'Tarah T', 'Initials': 'TT', 'LastName': 'Colaizy', 'Affiliation': 'Department of Pediatrics, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Deanne E', 'Initials': 'DE', 'LastName': 'Wilson-Costello', 'Affiliation': ""Department of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH, USA.""}, {'ForeName': 'Isabell B', 'Initials': 'IB', 'LastName': 'Purdy', 'Affiliation': 'Department of Pediatrics, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Hintz', 'Affiliation': ""Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA, USA.""}, {'ForeName': 'Roy J', 'Initials': 'RJ', 'LastName': 'Heyne', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Myers', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Janell', 'Initials': 'J', 'LastName': 'Fuller', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Merhar', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Harmon', 'Affiliation': 'Department of Pediatrics, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Peralta-Carcelen', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Howard W', 'Initials': 'HW', 'LastName': 'Kilbride', 'Affiliation': ""Department of Pediatrics, Children's Mercy Hospital and University of Missouri Kansas City School of Medicine, Kansas City, MO, USA.""}, {'ForeName': 'Nathalie L', 'Initials': 'NL', 'LastName': 'Maitre', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USA.""}, {'ForeName': 'Betty R', 'Initials': 'BR', 'LastName': 'Vohr', 'Affiliation': ""Department of Pediatrics, Women & Infants' Hospital, Brown University, Providence, RI, USA.""}, {'ForeName': 'Girija', 'Initials': 'G', 'LastName': 'Natarajan', 'Affiliation': 'Department of Pediatrics, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mintz-Hittner', 'Affiliation': 'Department of Ophthalmology and Visual Science, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Graham E', 'Initials': 'GE', 'LastName': 'Quinn', 'Affiliation': ""Department of Ophthalmology, The Children's Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Wallace', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Olson', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Faruk H', 'Initials': 'FH', 'LastName': 'Orge', 'Affiliation': ""Department of Ophthalmology, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH, USA.""}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Tsui', 'Affiliation': 'Department of Ophthalmology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gaynon', 'Affiliation': ""Department of Ophthalmology, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA, USA.""}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Hutchinson', 'Affiliation': ""Department of Ophthalmology, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA.""}, {'ForeName': 'Yu-Guang', 'Initials': 'YG', 'LastName': 'He', 'Affiliation': 'Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Winter', 'Affiliation': 'Division of Ophthalmology/Department of Surgery, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Haider', 'Affiliation': 'Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Cogen', 'Affiliation': 'Department of Ophthalmology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Hug', 'Affiliation': ""Department of Ophthalmology, Children's Mercy Hospital and University of Missouri Kansas City School of Medicine, Kansas City, MO, USA.""}, {'ForeName': 'Don L', 'Initials': 'DL', 'LastName': 'Bremer', 'Affiliation': ""Department of Ophthalmology, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Donahue', 'Affiliation': 'Alpert Medical School of Brown University and Consulting Staff, Women & Infants Hospital of Rhode Island, Providence, RI, USA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Lucas', 'Affiliation': 'Department of Ophthalmology, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Dale L', 'Initials': 'DL', 'LastName': 'Phelps', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Rosemary D', 'Initials': 'RD', 'LastName': 'Higgins', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA. rhiggin@gmu.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-021-01018-5']
484,33761461,"Time Course of Neuromuscular, Hormonal, and Perceptual Responses Following Moderate- and High-Load Resistance Priming Exercise.","PURPOSE


The aim of this study was to map responses over 32 hours following high-load (HL) and moderate-load (ML) half-squat priming.
METHODS


Fifteen participants completed control, HL (87% 1RM), and ML (65% 1RM) activities in randomized, counterbalanced order. Countermovement jump (CMJ), squat jump (SJ), saliva testosterone, saliva cortisol, and perceptual measures were assessed before and 5 minutes, 8 hours, 24 hours, and 32 hours after each activity. Results are presented as percentage change from baseline and 95% confidence interval (CI). Cliff delta was used to determine threshold for group changes.
RESULTS


SJ height increased by 4.5% (CI = 2.2-6.8, Cliff delta = 0.20) 8 hours following HL. CMJ and SJ improved by 6.1% (CI = 2.1-7.8, Cliff delta = 0.27) and 6.5% (CI = 1.2-11.8, Cliff delta = 0.30), respectively, 32 hours after ML. No clear diurnal changes in CMJ or SJ occurred 8 hours following control; however, increases of 3.9% (CI = 2.9-9.2, Cliff delta = 0.26) and 4.5% (CI = 0.9-8.1, Cliff delta = 0.24), respectively, were observed after 32 hours. Although diurnal changes in saliva hormone concentration occurred (Cliff delta = 0.37-0.92), the influence of priming was unclear. Perceived ""physical feeling"" was greater 8 hours following HL (Cliff delta = 0.36) and 32 hours after ML and control (Cliff delta = 0.17-0.34).
CONCLUSIONS


HL priming in the morning may result in small improvements in jump output and psychophysiological state in the afternoon. Similar improvements were observed in the afternoon the day after ML priming.",2021,"Perceived ""physical feeling"" was greater 8 hours following HL (Cliff delta = 0.36) and 32 hours after ML and control (Cliff delta = 0.17-0.34).
","['Fifteen participants completed control, HL (87% 1RM), and ML (65% 1RM) activities in randomized, counterbalanced order']","['high-load (HL) and moderate-load (ML) half-squat priming', 'Moderate- and High-Load Resistance Priming Exercise']","['Countermovement jump (CMJ), squat jump (SJ), saliva testosterone, saliva cortisol, and perceptual measures', 'saliva hormone concentration', 'Perceived ""physical feeling', 'jump output and psychophysiological state', 'Time Course of Neuromuscular, Hormonal, and Perceptual Responses', 'SJ height', 'CMJ and SJ']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C2938869', 'cui_str': 'Saliva testosterone'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",15.0,0.0960461,"Perceived ""physical feeling"" was greater 8 hours following HL (Cliff delta = 0.36) and 32 hours after ML and control (Cliff delta = 0.17-0.34).
","[{'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Harrison', 'Affiliation': ''}, {'ForeName': 'Lachlan P', 'Initials': 'LP', 'LastName': 'James', 'Affiliation': ''}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Jenkins', 'Affiliation': ''}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McGuigan', 'Affiliation': ''}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Schuster', 'Affiliation': ''}, {'ForeName': 'Vincent G', 'Initials': 'VG', 'LastName': 'Kelly', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0646']
485,33356994,Separating insulin-mediated and non-insulin-mediated glucose uptake during and after aerobic exercise in type 1 diabetes.,"Aerobic exercise in type 1 diabetes (T1D) causes rapid increase in glucose utilization due to muscle work during exercise, followed by increased insulin sensitivity after exercise. Better understanding of these changes is necessary for models of exercise in T1D. Twenty-six individuals with T1D underwent three sessions at three insulin rates (100%, 150%, 300% of basal). After 3-h run-in, participants performed 45 min aerobic exercise (moderate or intense). We determined area under the curve for endogenous glucose production (AUC EGP ) and rate of glucose disappearance (AUC Rd ) over 45 min from exercise start. A novel application of linear regression of R d  across the three insulin sessions allowed separation of insulin-mediated from non-insulin-mediated glucose uptake before, during, and after exercise. AUC Rd  increased 12.45 mmol/L (CI = 10.33-14.58,  P  < 0.001) and 13.13 mmol/L (CI = 11.01-15.26,  P  < 0.001) whereas AUC EGP  increased 1.66 mmol/L (CI = 1.01-2.31,  P  < 0.001) and 3.46 mmol/L (CI = 2.81-4.11,  P  < 0.001) above baseline during moderate and intense exercise, respectively. AUC EGP  increased during intense exercise by 2.14 mmol/L (CI = 0.91-3.37,  P  < 0.001) compared with moderate exercise. There was significant effect of insulin infusion rate on AUC Rd  equal to 0.06 mmol/L per % above basal rate (CI = 0.05-0.07,  P  < 0.001). Insulin-mediated glucose uptake rose during exercise and persisted hours afterward, whereas non-insulin-mediated effect was limited to the exercise period. To our knowledge, this method of isolating dynamic insulin- and non-insulin-mediated uptake has not been previously employed during exercise. These results will be useful in informing glucoregulatory models of T1D. The study has been registered at www.clinicaltrials.gov as NCT03090451. NEW & NOTEWORTHY  Separating insulin and non-insulin glucose uptake dynamically during exercise in type 1 diabetes has not been done before. We use a multistep process, including a previously described linear regression method, over three insulin infusion sessions, to perform this separation and can graph these components before, during, and after exercise for the first time.",2021,"AUC Rd  increased 12.45 mmol/L (CI = 10.33-14.58,  P  < 0.001) and 13.13 mmol/L (CI = 11.01-15.26,  P  < 0.001) whereas AUC EGP  increased 1.66 mmol/L (CI = 1.01-2.31,  P  < 0.001) and 3.46 mmol/L (CI = 2.81-4.11,  P  < 0.001) above baseline during moderate and intense exercise, respectively.",['T1D. Twenty-six individuals with T1D'],"['Aerobic exercise', '45\u2009min aerobic exercise (moderate or intense']","['AUC Rd', 'AUC EGP  increased during intense exercise', 'Insulin-mediated glucose uptake', 'endogenous glucose production (AUC EGP ) and rate of glucose disappearance (AUC Rd ', 'AUC EGP', 'insulin infusion rate']","[{'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C4544151', 'cui_str': 'Insulin infusion rate'}]",,0.0344397,"AUC Rd  increased 12.45 mmol/L (CI = 10.33-14.58,  P  < 0.001) and 13.13 mmol/L (CI = 11.01-15.26,  P  < 0.001) whereas AUC EGP  increased 1.66 mmol/L (CI = 1.01-2.31,  P  < 0.001) and 3.46 mmol/L (CI = 2.81-4.11,  P  < 0.001) above baseline during moderate and intense exercise, respectively.","[{'ForeName': 'Thanh-Tin P', 'Initials': 'TP', 'LastName': 'Nguyen', 'Affiliation': 'School of Medicine, Oregon Health & Science University (OHSU), Portland, Oregon.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Jacobs', 'Affiliation': 'Department of Biomedical Engineering, Oregon Health & Science University (OHSU), Portland, Oregon.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Castle', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Wilson', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Kuehl', 'Affiliation': 'Department of Sports Medicine, Oregon Health & Science University (OHSU), Portland, Oregon.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Branigan', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Gabo', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Guillot', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Riddell', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Haidar', 'Affiliation': 'Institut de Recherches Cliniques de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'El Youssef', 'Affiliation': 'Department of Biomedical Engineering, Oregon Health & Science University (OHSU), Portland, Oregon.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00534.2020']
486,33763659,Populating preterm infants with probiotics.,A randomized placebo-controlled trial by Martí et al. 1  shows that probiotic supplementation of premature infants can modulate the infant gut microbiota soon after birth.,2021,1  shows that probiotic supplementation of premature infants can modulate the infant gut microbiota soon after birth.,"['Populating preterm infants with probiotics', 'premature infants']","['probiotic supplementation', 'placebo']",[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.467501,1  shows that probiotic supplementation of premature infants can modulate the infant gut microbiota soon after birth.,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Dalby', 'Affiliation': 'Gut Microbes & Health, Quadram Institute Bioscience, Norwich Research Park, Norwich, UK.'}, {'ForeName': 'Lindsay J', 'Initials': 'LJ', 'LastName': 'Hall', 'Affiliation': 'Gut Microbes & Health, Quadram Institute Bioscience, Norwich Research Park, Norwich, UK.'}]",Cell reports. Medicine,['10.1016/j.xcrm.2021.100224']
487,33771941,Time Spent Near V˙O2max During Different Cycling Self-Paced Interval Training Protocols.,"PURPOSE


Cyclists may increase exercise intensity by prolonging exercise duration and/or shortening the recovery period during self-paced interval training, which could impact the time spent near V˙O2max. Thus, the main objective of this study was to compare the time spent near V˙O2max during 4 different self-paced interval training sessions.
METHODS


After an incremental test, 11 cyclists (mean [SD]: age = 34.4 [6.2] y; V˙O2max=55.7 [7.4] mL·kg-1·min-1) performed in a randomized order 4 self-paced interval training sessions characterized by a work-recovery ratio of 4:1 or 2:1. Sessions comprised 4 repetitions of 4 minutes of cycling with 1 minute (4/1) or 2 minutes (4/2) of active recovery or 8 minutes of cycling with 2 minutes (8/2) or 4 minutes (8/4) of active recovery. Time spent at 90% to 94% (t90V˙O2max), ≥95% (t95V˙O2max), and 90% to 100% V˙O2max (tV˙O2max) was analyzed in absolute terms and relative to the total work duration. Power output, heart rate, blood lactate, and rating of perceived exertion were compared.
RESULTS


The 8/4 session provided higher absolute tV˙O2max and t95V˙O2max than 8/2 (P = .015 and .029) and 4/1 (P = .002 and .047). The 4/2 protocol elicited higher relative tV˙O2max (47.7% [26.9%]) and t95V˙O2max (23.5% [22.7%]) than 4/1 (P = .015 and .028) and 8/2 (P < .01). Session 4/2 (275 [23] W) elicited greater mean power output (P < .01) than 4/1 (261 [27] W), 8/4 (250 [25] W), and 8/2 (234 [23] W).
CONCLUSIONS


Self-paced interval training composed of 4-minute and 8-minute work periods efficiently elicit tV˙O2max, but protocols with a work-recovery ratio of 2:1 (ie, 4/2 and 8/4) could be prioritized to maximize tV˙O2max.",2021,The 8/4 session provided higher absolute tV˙O2max and t95V˙O2max than 8/2 (P = .015 and .029) and 4/1 (P = .002 and .047).,['11 cyclists (mean [SD]: age = 34.4 [6.2]\xa0y; V˙O2max=55.7 [7.4] mL·kg-1·min-1'],[],"['Time spent', 't95V˙O2max', 'time spent near V˙O2max', 'absolute tV˙O2max and t95V˙O2max', 'relative tV˙O2max', 'Time Spent Near V˙O2max', 'mean power output', 'Power output, heart rate, blood lactate, and rating of perceived exertion']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C4517858', 'cui_str': '7.4'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",,0.0470526,The 8/4 session provided higher absolute tV˙O2max and t95V˙O2max than 8/2 (P = .015 and .029) and 4/1 (P = .002 and .047).,"[{'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': ""Dall' Agnol"", 'Affiliation': ''}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Turnes', 'Affiliation': ''}, {'ForeName': 'Ricardo Dantas', 'Initials': 'RD', 'LastName': 'De Lucas', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0314']
488,33771940,Additional Clothing Increases Heat Load in Elite Female Rugby Sevens Players.,"PURPOSE


To determine whether elite female rugby sevens players are exposed to core temperatures (Tc) during training in the heat that replicate the temperate match demands previously reported and to investigate whether additional clothing worn during a hot training session meaningfully increases the heat load experienced.
METHODS


A randomized parallel-group study design was employed, with all players completing the same approximately 70-minute training session (27.5°C-34.8°C wet bulb globe temperature) and wearing a standardized training ensemble (synthetic rugby shorts and training tee [control (CON); n = 8]) or additional clothing (standardized training ensemble plus compression garments and full tracksuit [additional clothing (AC); n = 6]). Groupwise differences in Tc, sweat rate, GPS-measured external locomotive output, rating of perceived exertion, and perceptual thermal load were compared.
RESULTS


Mean (P = .006, ηp2=.88) and peak (P < .001, ηp2=.97) Tc were higher in AC compared with CON during the training session. There were no differences in external load (F4,9 = 0.155, P = .956, Wilks Λ = 0.935, ηp2=.06) or sweat rate (P = .054, Cohen d = 1.09). A higher rating of perceived exertion (P = .016, Cohen d = 1.49) was observed in AC compared with CON. No exertional-heat-illness symptomology was reported in either group.
CONCLUSIONS


Player Tc is similar between training performed in hot environments and match play in temperate conditions when involved for >6 minutes. Additional clothing is a viable and effective method to increase heat strain in female rugby sevens players without compromising training specificity or external locomotive capacity.",2021,"A higher rating of perceived exertion (P = .016, Cohen d = 1.49) was observed in AC compared with CON.","['all players completing the same approximately 70-minute training session (27.5°C-34.8', 'Elite Female Rugby Sevens Players', 'female rugby sevens players', 'elite female rugby sevens players']","['C wet bulb globe temperature) and wearing a standardized training ensemble (synthetic rugby shorts and training tee [control (CON); n = 8]) or additional clothing (standardized training ensemble plus compression garments and full tracksuit [additional clothing (AC', 'CON']","['external load', 'exertional-heat-illness symptomology', 'sweat rate', 'Tc, sweat rate, GPS-measured external locomotive output, rating of perceived exertion, and perceptual thermal load']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0025148', 'cui_str': 'Medulla oblongata structure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1456556', 'cui_str': 'Heat illness'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",8.0,0.035541,"A higher rating of perceived exertion (P = .016, Cohen d = 1.49) was observed in AC compared with CON.","[{'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Henderson', 'Affiliation': ''}, {'ForeName': 'Bryna C R', 'Initials': 'BCR', 'LastName': 'Chrismas', 'Affiliation': ''}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Novak', 'Affiliation': ''}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'Fransen', 'Affiliation': ''}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Coutts', 'Affiliation': ''}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0620']
489,33769837,Community  qigong  for People with Multiple Sclerosis: A Pragmatic Feasibility Study.,"Objectives:   qigong , a traditional Chinese mind-body exercise, has been shown to improve balance and gait in several neurological conditions; however, community-delivered  qigong  has never been assessed for people with multiple sclerosis (MS). The authors assessed the feasibility of community  qigong  classes for people with MS and explored outcomes of balance, gait, and quality of life (QOL).  Design:  Twenty adults with MS were randomly assigned to 10 weeks of community  qigong  classes or wait-list control.  Settings/Location:  Portland, Oregon.  Subjects:  People with MS.  Intervention:  Community qigong classes.  Outcome measures:  Feasibility criteria included recruitment, retention, adherence, and ability to participate in  qigong  movements. Secondary outcome measures included physical tests of mobility, gait, and balance and participant-reported mobility, depression, anxiety, fatigue, and QOL.  Results:  Recruitment of eligible and interested people with MS was feasible. Retention in the trial was 60%. Completers attended a mean of 7 of 10 classes. All completers participated with no or minor modifications to  qigong  movements. Exploratory within-group analyses showed trends toward improved mental health, QOL, and reduced fatigue and depression. Several participants spontaneously reported improved energy, flexibility, sleep, and mobility.  Conclusions:  Community  qigong  may be a feasible form of exercise for people with MS. To improve retention and capture potential effects of  qigong  on physical function and quality of life, future studies might consider pragmatic trials with tiered level classes, simpler forms of  qigong , and/or refined inclusion criteria (CTR#: NCT04585659).",2021,"Exploratory within-group analyses showed trends toward improved mental health, QOL, and reduced fatigue and depression.","['Subjects:  People with MS', 'People with Multiple Sclerosis', 'people with MS', 'All completers participated with no or minor modifications to  qigong  movements', 'Twenty adults with MS', 'people with multiple sclerosis (MS']","['traditional Chinese mind-body exercise', 'Community  qigong', 'qigong', 'community  qigong']","['physical tests of mobility, gait, and balance and participant-reported mobility, depression, anxiety, fatigue, and QOL', 'mental health, QOL, and reduced fatigue and depression', 'energy, flexibility, sleep, and mobility', 'balance, gait, and quality of life (QOL', 'physical function and quality of life', 'Outcome measures:  Feasibility criteria included recruitment, retention, adherence, and ability to participate in  qigong  movements']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",20.0,0.0425697,"Exploratory within-group analyses showed trends toward improved mental health, QOL, and reduced fatigue and depression.","[{'ForeName': 'Lita', 'Initials': 'L', 'LastName': 'Buttolph', 'Affiliation': 'Helfgott Research Institute, National University of Natural Medicine, Portland, OR, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Corn', 'Affiliation': 'Helfgott Research Institute, National University of Natural Medicine, Portland, OR, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hanes', 'Affiliation': 'Helfgott Research Institute, National University of Natural Medicine, Portland, OR, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Bradley', 'Affiliation': 'Helfgott Research Institute, National University of Natural Medicine, Portland, OR, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Senders', 'Affiliation': 'Helfgott Research Institute, National University of Natural Medicine, Portland, OR, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0481']
490,33777256,Yoga v. health education for attentional processes relevant to major depressive disorder.,"Objectives


Research has shown that yoga may be an effective adjunctive treatment for persistent depression, the benefits of which may accumulate over time. The objectives of this study were to evaluate the following in a sample of persistently depressed individuals: whether yoga increases mindfulness and whether yoga attenuates rumination. Rumination and mindfulness both represent attentional processes relevant for onset and maintenance of depressive episodes.
Methods


One-hundred-ten individuals who were persistently depressed despite ongoing use of pharmacological treatment were recruited into an RCT comparing yoga with a health education class. Mindfulness and rumination were assessed at baseline and across 3 time points during the ten-week intervention.
Results


Findings demonstrate that, compared to health education, yoga was associated with higher mean levels of the observe facet of mindfulness relative to the control group during the intervention period ( p  =.004,  d  =0.38), and that yoga was associated with a faster rate of increase in levels of acting with awareness over the intervention period ( p = .03,  f 2  =0.027). There were no differences between intervention groups with respect to rumination.
Conclusions


Results suggest a small effect of yoga on components of mindfulness during a 10-week intervention period. Previous research suggests that continued assessment after the initial 10 weeks may reveal continued improvement. Future research may also examine moderators of the impact of yoga on mindfulness and rumination, including clinical factors such as depression severity or depression chronicity, or demographic factors such as age.",2021,"There were no differences between intervention groups with respect to rumination.
",['Methods\n\n\nOne-hundred-ten individuals who were persistently depressed despite ongoing use of pharmacological treatment were recruited into an RCT comparing yoga with a health education class'],"['yoga increases mindfulness and whether yoga attenuates rumination', 'Yoga v. health education']","['levels of acting with awareness', 'Mindfulness and rumination']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}]",110.0,0.018066,"There were no differences between intervention groups with respect to rumination.
","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'West', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Tremont', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Ivan W', 'Initials': 'IW', 'LastName': 'Miller', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Uebelacker', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI.'}]",Mindfulness,['10.1007/s12671-020-01519-y']
491,33768702,Personality disorder among youth with first episode psychotic mania: An important target for specific treatment?,"AIM


Personality disorder is a common co-occurrence ('comorbidity') among patients with bipolar disorder and appears to affect outcome negatively. However, there is little knowledge about the impact of this comorbidity in the early phases of bipolar disorder. We examined the prevalence and effect of personality disorder co-occurrence on outcome in a cohort of youth with first episode mania with psychotic features.
METHODS


Seventy-one first episode mania patients, aged 15-29, were assessed at baseline, 6, 12, and 18 months as part of a randomized controlled trial of olanzapine and chlorpromazine as add-on to lithium in first episode mania with psychotic features. The current study involved secondary analysis of trial data.
RESULTS


A co-occurring clinical personality disorder diagnosis was present in 16.9% of patients. Antisocial and narcissistic personality disorders were the most common diagnoses. Patients with co-occurring personality disorder had higher rates of readmission to hospital, lower rates of symptomatic recovery and poorer functional levels at 6 months, but these differences disappeared after 12 and 18 months.
CONCLUSIONS


In the early phase of bipolar disorder, patients with personality disorder comorbidity display delayed symptomatic and functional recovery and increased likelihood to need hospital readmissions. These observations suggest that routine assessment for personality disorder and specific interventions are important in order to improve short-term treatment efficacy in this subgroup.",2022,"Patients with co-occurring personality disorder had higher rates of readmission to hospital, lower rates of symptomatic recovery and poorer functional levels at 6 months, but these differences disappeared after 12 and 18 months.
","['Patients with co-occurring personality disorder', 'cohort of youth with first episode mania with psychotic features', 'Seventy-one first episode mania patients, aged 15-29, were assessed at baseline, 6, 12, and 18\u2009months', 'Personality disorder among youth with first episode psychotic mania', 'patients with bipolar disorder', 'in first episode mania with psychotic features']","['lithium', 'olanzapine and chlorpromazine']","['Antisocial and narcissistic personality disorders', 'rates of readmission to hospital, lower rates of symptomatic recovery and poorer functional levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0031212', 'cui_str': 'Personality disorder'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}]","[{'cui': 'C0233523', 'cui_str': 'Antisocial behavior'}, {'cui': 'C0027402', 'cui_str': 'Narcissistic personality disorder'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.148945,"Patients with co-occurring personality disorder had higher rates of readmission to hospital, lower rates of symptomatic recovery and poorer functional levels at 6 months, but these differences disappeared after 12 and 18 months.
","[{'ForeName': 'Melissa K', 'Initials': 'MK', 'LastName': 'Hasty', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Macneil', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Cotton', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kader', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}, {'ForeName': 'Aswin', 'Initials': 'A', 'LastName': 'Ratheesh', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ramain', 'Affiliation': 'Department of Psychiatry CHUV, Treatment and Early Intervention in Psychosis Program (TIPP), Service of General Psychiatry, Lausanne University, Lausanne, Switzerland.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Chanen', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Conus', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}]",Early intervention in psychiatry,['10.1111/eip.13150']
492,33774892,An integrative healthcare model with heartfulness meditation and care coordination improves outcomes in cyclic vomiting syndrome.,"BACKGROUND


Cyclic vomiting syndrome (CVS) is associated with psychosocial comorbidity and often triggered by stress. Since the current disease-centered care model does not address psychosocial factors, we hypothesized that holistic, patient-centered care integrating meditation and addressing psychosocial needs through a care coordinator will improve healthcare outcomes in CVS.
METHODS


We conducted a prospective randomized controlled trial: 49 patients with CVS (mean age: 34 ± 14 years; 81% female) were randomized to conventional health care (controls) or Integrative Health care (IHC) (27: controls, 22: IHC). The IHC group was assigned a care coordinator and received meditation with a certified instructor. Outcomes including psychological distress, coping strategies to manage chronic stress, cognitive symptom management, and Health-Related Quality of Life (HRQoL) were measured.
KEY RESULTS


In intention-to-treat analyses, patients receiving IHC showed significant improvement in multiple domains of coping including positive reframing, planning, and reduction in self-blame (p values ≤0.05), and physical HRQoL (p = 0.03) at 6 months. They also leaned toward spirituality/religion as a coping measure (p ≤ 0.02 at 3 and 6 months). Subgroup analysis of compliant patients showed additional benefit with significant reduction in psychological distress (p = 0.04), improvement in sleep quality (p = 0.03), reduction in stress levels (0.02), improvement in physical HRQoL (0.04), and further improvement in other domains of coping (p < 0.05).
CONCLUSIONS AND INFERENCES


An IHC model incorporating meditation and care coordination improves patient outcomes in CVS and is a useful adjunct to standard treatment. Studies to determine the independent effects of meditation and care coordination are warranted.",2021,"In intention-to-treat analyses, patients receiving IHC showed significant improvement in multiple domains of coping including positive reframing, planning, and reduction in self-blame (p values ≤0.05), and physical HRQoL (p = 0.03) at 6 months.",['49 patients with CVS (mean age: 34\xa0±\xa014\xa0years; 81% female'],"['heartfulness meditation and care coordination', 'conventional health care (controls) or Integrative Health care (IHC', 'care coordinator and received meditation with a certified instructor']","['sleep quality', 'psychological distress', 'physical HRQoL', 'psychological distress, coping strategies to manage chronic stress, cognitive symptom management, and Health-Related Quality of Life (HRQoL', 'multiple domains of coping including positive reframing, planning, and reduction in self-blame', 'cyclic vomiting syndrome', 'reduction in stress levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152164', 'cui_str': 'Cyclical vomiting syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C4708569', 'cui_str': 'Care coordinator'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0152164', 'cui_str': 'Cyclical vomiting syndrome'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",49.0,0.0887831,"In intention-to-treat analyses, patients receiving IHC showed significant improvement in multiple domains of coping including positive reframing, planning, and reduction in self-blame (p values ≤0.05), and physical HRQoL (p = 0.03) at 6 months.","[{'ForeName': 'Thangam', 'Initials': 'T', 'LastName': 'Venkatesan', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Porcelli', 'Affiliation': 'Department of Psychology, Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'Anagha', 'Initials': 'A', 'LastName': 'Matapurkar', 'Affiliation': 'Heartfulness Institute, Austin, TX, USA.'}, {'ForeName': 'Vishnu Charan', 'Initials': 'VC', 'LastName': 'Suresh Kumar', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Aniko', 'Initials': 'A', 'LastName': 'Szabo', 'Affiliation': 'Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Wieloch', 'Affiliation': 'Froedtert Hospital, Milwaukee, WI, USA.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.14132']
493,33757609,The intestinal microbiota as a predictor for antidepressant treatment outcome in geriatric depression: a prospective pilot study.,"OBJECTIVES


(1) To investigate if gut microbiota can be a predictor of remission in geriatric depression and to identify features of the gut microbiota that is associated with remission. (2) To determine if changes in gut microbiota occur with remission in geriatric depression.
DESIGN


Secondary analysis of a parent randomized placebo-controlled trial (NCT02466958).
SETTING


Los Angeles, CA, USA (2016-2018).
PARTICIPANTS


Seventeen subjects with major depressive disorder, over 60 years of age, 41.2% female.
INTERVENTION


Levomilacipran (LVM) or placebo.
MEASUREMENTS


Remission was defined by Hamilton Depression Rating Scale score of 6 or less at 12 weeks. 16S-ribosomal RNA sequencing based fecal microbiota composition and diversity were measured at baseline and 12 weeks. Differences in fecal microbiota were evaluated between remitters and non-remitters as well as between baseline and post-treatment samples. LVM and placebo groups were combined in all the analyses.
RESULTS


Baseline microbiota showed no community level α-diversity or β-diversity differences between remitters and non-remitters. At the individual taxa level, a random forest classifier created with nine genera from the baseline microbiota was highly accurate in predicting remission (AUC = .857). Of these, baseline enrichment of Faecalibacterium, Agathobacter and Roseburia relative to a reference frame was associated with treatment outcome of remission. Differential abundance analysis revealed significant genus level changes from baseline to post-treatment in remitters, but not in non-remitters.
CONCLUSIONS


This is the first study demonstrating fecal microbiota as a potential predictor of treatment response in geriatric depression. Our findings need to be confirmed in larger prospective studies.",2022,"Differential abundance analysis revealed significant genus level changes from baseline to post-treatment in remitters, but not in non-remitters.
CONCLUSIONS


","['Seventeen subjects with major depressive disorder, over 60 years of age, 41.2% female', 'Los Angeles, CA, USA (2016-2018', 'geriatric depression']","['Levomilacipran (LVM) or placebo', 'placebo', 'LVM and placebo']","['community level α-diversity or β-diversity differences', 'Hamilton Depression Rating Scale score', 'fecal microbiota composition and diversity', 'fecal microbiota']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",17.0,0.259534,"Differential abundance analysis revealed significant genus level changes from baseline to post-treatment in remitters, but not in non-remitters.
CONCLUSIONS


","[{'ForeName': 'S Melanie', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Tien S', 'Initials': 'TS', 'LastName': 'Dong', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Krause-Sorio', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Prabha', 'Initials': 'P', 'LastName': 'Siddarth', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Michaela M', 'Initials': 'MM', 'LastName': 'Milillo', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Lagishetty', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Datta', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Yesenia', 'Initials': 'Y', 'LastName': 'Aguilar-Faustino', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Jacobs', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lavretsky', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, CA, USA.'}]",International psychogeriatrics,['10.1017/S1041610221000120']
494,33770278,Endoscopic thermocoagulation hemostasis for acute non-varicose upper gastrointestinal hemorrhage: a randomized controlled study.,"OBJECTIVE


This study evaluated the application of the bipolar electrocoagulation catheter via a peripheral-to-central (3 + 1) technique, relative to directly pressing only at the center of the bleeding site (direct-stroke), to effect endoscopic hemostasis of acute non-varicose gastrointestinal bleeding (ANVUGIB).
METHODS


Patients (n = 148) with endoscopically diagnosed ANVUGIB were randomly apportioned to receive treatment by 3 + 1 (n = 78) or direct-stroke (n = 70) application of the bipolar electrocoagulation catheter. The 3 + 1 strategy required pressing at3 narrowly restricted sites equidistant peripheral and center to the site of bleeding. The rates of initial success, hemostasis time, and number of compressions were compared according to intention-to-treat (ITT) or per protocol (PP).
RESULTS


The ITT (PP) rate of initial hemostatic success in patients receiving the 3 + 1 catheter was 91.02% (95.9%); and for the direct-stroke group was 71.42% (76.9%). For Forrest IIa lesions specifically, these rates were respectively 91.70% (97.1%) and 63.9% (67.6%). The ITT (PP) hemostasis times of the 3 + 1 and direct-stroke groups were 10.96 ± 3.28 (10.65 ± 2.90) and 14.27 ± 6.58 (14.12 ± 6.67) min; and the number of compressions numbered 5.73 ± 1.98 (5.42 ± 1.46) and 6.47 ± 2.82 (6.16 ± 2.47).
CONCLUSION


During thermocoagulation treatment of ANVUGIB via bipolar electrocoagulation catheter, the 3 + 1 strategy showed a significantly higher rate of successful initial hemostasis relative to the direct-stroke technique, and shorter hemostasis time, with no increase in total procedural steps.",2022,"RESULTS


The ITT (PP) rate of initial hemostatic success in patients receiving the 3 + 1 catheter was 91.02% (95.9%); and for the direct-stroke group was 71.42% (76.9%).","['acute non-varicose upper gastrointestinal hemorrhage', 'Patients (n\u2009=\u2009148) with endoscopically diagnosed ANVUGIB']","['direct-stroke (n\u2009=\u200970) application of the bipolar electrocoagulation catheter', 'Endoscopic thermocoagulation hemostasis', 'bipolar electrocoagulation catheter via a peripheral-to-central (3\u2009+\u20091) technique']","['rate of successful initial hemostasis', 'total procedural steps', 'rates of initial success, hemostasis time, and number of compressions', 'hemostasis time', 'ITT (PP) rate of initial hemostatic success', 'ITT (PP) hemostasis times']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439652', 'cui_str': 'Varicose'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal bleeding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",148.0,0.0662306,"RESULTS


The ITT (PP) rate of initial hemostatic success in patients receiving the 3 + 1 catheter was 91.02% (95.9%); and for the direct-stroke group was 71.42% (76.9%).","[{'ForeName': 'Ou', 'Initials': 'O', 'LastName': 'Qian', 'Affiliation': 'Department of Endoscopy Center, The First Afilliated Hospital of Fujian Medical University, Chazhong Road 20, Fuzhou, 350004, Fujian, China.'}, {'ForeName': 'Qiaoxian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing Department, The First Afilliated Hospital of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Endoscopy Center, The First Afilliated Hospital of Fujian Medical University, Chazhong Road 20, Fuzhou, 350004, Fujian, China.'}, {'ForeName': 'Chiyue', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': 'Department of Endoscopy Center, The First Afilliated Hospital of Fujian Medical University, Chazhong Road 20, Fuzhou, 350004, Fujian, China.'}, {'ForeName': 'Lanying', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Endoscopy Center, The First Afilliated Hospital of Fujian Medical University, Chazhong Road 20, Fuzhou, 350004, Fujian, China.'}, {'ForeName': 'Jinhui', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'Department of Endoscopy Center, The First Afilliated Hospital of Fujian Medical University, Chazhong Road 20, Fuzhou, 350004, Fujian, China.'}, {'ForeName': 'Ze-Hao', 'Initials': 'ZH', 'LastName': 'Zhuang', 'Affiliation': 'Department of Endoscopy Center, The First Afilliated Hospital of Fujian Medical University, Chazhong Road 20, Fuzhou, 350004, Fujian, China. zhuang203@yeah.net.'}]",Surgical endoscopy,['10.1007/s00464-021-08448-4']
495,33771956,Contact Lens Adaption in Neophytes.,"SIGNIFICANCE


Clinicians commonly either recommend patients begin contact lens (CL) wear full time or suggest that patients should gradually increase their wear times during the first few days of wear. This study found no differences between these two wear schedules, suggesting that patient preference may be the best schedule.
PURPOSE


The purpose of this study was to determine if there are any clinical differences in neophyte, 2-week, reusable soft CL wearers who were randomized to either a full-time or a gradually increasing wear time schedule.
METHODS


This was an investigator-masked, three-visit, randomized, clinical trial. Participants were randomized to wear their CLs full time starting on the first day or gradually starting with 2 hours of wear on the first day and increasing wear by 2 hours each day until 8 hours or more of wear per day was achieved. Symptoms (Ocular Surface Disease Index and visual analog scale) and ocular surface signs (tear breakup time, extent of corneal staining, and Schirmer test I) were evaluated at each visit.
RESULTS


A total of 25 participants were randomized, with 21 participants completing at least 1 week of follow-up. Completed participants had a mean ± standard deviation age of 23.5 ± 3.0 years, and 48% were female. No significant between-group differences were found when comparing the full-time and gradual wear time schedule groups at 2 weeks (all, P > .32): Ocular Surface Disease Index (10.8 ± 8.5 vs. 16.3 ± 18.8), visual analog scale (89.0 ± 9.7 vs. 81.8 ± 18.7), tear breakup time (11.7 ± 7.0 vs. 9.8 ± 2.7), extent of corneal staining (0.0 ± 0.1 vs. 0.3 ± 0.5), or Schirmer test I (15.9 ± 8.8 vs. 21.2 ± 12.5).
CONCLUSIONS


No between-group differences were found for any metric evaluated, which suggests that the best wear schedule may be the one that best suits the neophyte CL wearer's lifestyle.",2021,"No significant between-group differences were found when comparing the full-time and gradual wear time schedule groups at 2 weeks (all, P > .32):","['Completed participants had a mean ± standard deviation age of 23.5 ± 3.0 years, and 48% were female', 'A total of 25 participants']",[],"['Ocular Surface Disease Index', 'full-time and gradual wear time schedule', 'Symptoms (Ocular Surface Disease Index and visual analog scale) and ocular surface signs (tear breakup time, extent of corneal staining, and Schirmer test', 'tear breakup time', 'visual analog scale']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",[],"[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}]",25.0,0.380057,"No significant between-group differences were found when comparing the full-time and gradual wear time schedule groups at 2 weeks (all, P > .32):","[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Pucker', 'Affiliation': ''}, {'ForeName': 'Kelsy', 'Initials': 'K', 'LastName': 'Steele', 'Affiliation': 'The Ohio State University College of Optometry, Columbus, Ohio.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Rueff', 'Affiliation': 'The Ohio State University College of Optometry, Columbus, Ohio.'}, {'ForeName': 'Quentin X', 'Initials': 'QX', 'LastName': 'Franklin', 'Affiliation': 'School of Optometry, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'McClure', 'Affiliation': 'The Ohio State University College of Optometry, Columbus, Ohio.'}, {'ForeName': 'Keyur', 'Initials': 'K', 'LastName': 'Savla', 'Affiliation': 'School of Optometry, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Walline', 'Affiliation': 'The Ohio State University College of Optometry, Columbus, Ohio.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001662']
496,33771952,Effect of Vergence/Accommodative Therapy on Attention in Children with Convergence Insufficiency: A Randomized Clinical Trial.,"SIGNIFICANCE


The results of this study suggest that clinicians providing vergence/accommodative therapy for convergence insufficiency in children should not suggest that such treatment will lead to improvements in attention when compared with placebo treatment.
PURPOSE


This study aimed to compare the effects of 16 weeks of vergence/accommodative therapy and placebo therapy on changes in attention for children in the Convergence Insufficiency Treatment Trial-Attention and Reading Trial.
METHODS


Three hundred ten children 9 to 14 years old with convergence insufficiency were assigned to receive treatment with office-based vergence/accommodative therapy or placebo therapy. Attention tests were administered at baseline and after 16 weeks of treatment. The primary measure of attention was the Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior (SWAN) scale. Other measures included the Swanson, Nolan, and Pelham checklist; the Homework Problems Checklist; and the d2 Test of Attention. Within and between-group differences are reported using Cohen d effect sizes.
RESULTS


For the SWAN, there was no significant difference between the groups for the inattention scale parental report (d = 0.036; 95% confidence interval, -0.21 to 0.28) or for the hyperactivity impulsivity scale parental report (d = -0.003; 95% confidence interval, -0.24 to 0.24). Similar results were found for teacher reports and the secondary measures (d estimates from -0.97 to +0.10). There were, however, large within-group changes with d ≥ 1 in both treatment groups for the SWAN, the Homework Problems Checklist, and the d2 Test of Attention.
CONCLUSIONS


These results suggest that vergence/accommodative therapy is no better than placebo therapy in improving attention. Large improvements in inattention, completing homework, and selective and sustained attention were found in each group. However, these improvements cannot be attributed to improvements in vergence and accommodation and are likely due to nonspecific effects of an intensive therapy regimen.",2021,"For the SWAN, there was no significant difference between the groups for the inattention scale parental report (d = 0.036; 95% confidence interval, -0.21 to 0.28) or for the hyperactivity impulsivity scale parental report (d = -0.003","['Three hundred ten children 9 to 14 years old with convergence insufficiency', 'children in the Convergence Insufficiency Treatment Trial-Attention and Reading Trial', 'Children with Convergence Insufficiency']","['placebo', 'vergence/accommodative therapy and placebo therapy', 'office-based vergence/accommodative therapy or placebo therapy', 'Vergence/Accommodative Therapy']","['Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior (SWAN) scale', 'hyperactivity impulsivity scale parental report', 'inattention, completing homework, and selective and sustained attention', 'Swanson, Nolan, and Pelham checklist; the Homework Problems Checklist; and the d2 Test of Attention']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0271379', 'cui_str': 'Convergence insufficiency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233512', 'cui_str': 'Normal behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",310.0,0.164722,"For the SWAN, there was no significant difference between the groups for the inattention scale parental report (d = 0.036; 95% confidence interval, -0.21 to 0.28) or for the hyperactivity impulsivity scale parental report (d = -0.003","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001659']
497,33767798,Design and analysis considerations for a sequentially randomized HIV prevention trial.,"TechStep is a randomized trial of a mobile health interventions targeted towards transgender adolescents. The interventions include a short message system, a mobile-optimized web application, and electronic counseling. The primary outcomes are self-reported sexual risk behaviors and uptake of HIV preventing medication. In order that we may evaluate the efficacy of several different combinations of interventions, the trial has a sequentially randomized design. We use a causal framework to formalize the estimands of the primary and key secondary analyses of the TechStep trial data. Targeted minimum loss-based estimators of these quantities are described and studied in simulation.",2020,We use a causal framework to formalize the estimands of the primary and key secondary analyses of the TechStep trial data.,['transgender adolescents'],[],['self-reported sexual risk behaviors and uptake of HIV preventing medication'],"[{'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.234657,We use a causal framework to formalize the estimands of the primary and key secondary analyses of the TechStep trial data.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Benkeser', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Emory University.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Horvath', 'Affiliation': 'Department of Psychology, University of California, San Diego.'}, {'ForeName': 'Cathy J', 'Initials': 'CJ', 'LastName': 'Reback', 'Affiliation': 'Friends Research Institute.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rusow', 'Affiliation': 'Friends Research Institute.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hudgens', 'Affiliation': 'Department of Biostatistics, University of North Carolina, Chapel Hill.'}]",Statistics in biosciences,['10.1007/s12561-020-09274-3']
498,33779437,Cost-effectiveness of Guided Internet-Delivered Cognitive Behavioral Therapy in Comparison with Care-as-Usual for Patients with Insomnia in General Practice.,"STUDY OBJECTIVES


Clinical guidelines recommend cognitive-behavioral therapy for insomnia (CBT-I) as first-line treatment. However, provision of CBT-I is limited due to insufficient time and expertise. Internet-delivered CBT-I might bridge this gap. This study aimed to estimate the cost-effectiveness of guided, internet-delivered CBT-I (i-Sleep) compared to care-as-usual for insomnia patients in general practice over 26 weeks from a societal perspective.
METHODS


Primary outcomes were the Insomnia Severity Index (ISI, continuous score and clinically relevant response), and Quality-Adjusted Life Years (QALYs). Societal costs were assessed at baseline, and at 8 and 26 weeks. Missing data were imputed using multiple imputation. Statistical uncertainty around cost and effect differences was estimated using bootstrapping, and presented in cost-effectiveness planes and acceptability curves.
RESULTS


The difference in societal costs between i-Sleep and care-as-usual was not statistically significant (-€318; 95% CI -1282 to 645). Cost-effectiveness analyses revealed a 95% probability of i-Sleep being cost-effective compared to care-as-usual at ceiling ratios of €450/extra point of improvement in ISI score and €7,000/additional response to treatment, respectively. Cost-utility analysis showed a 67% probability of cost-effectiveness for i-Sleep compared to care-as-usual at a ceiling ratio of 20,000 €/QALY gained.
CONCLUSIONS


The internet-delivered intervention may be considered cost-effective for insomnia severity in comparison with care-as-usual from the societal perspective. However, the improvement in insomnia severity symptoms did not result in similar improvements in QALYs.",2022,The difference in societal costs between i-Sleep and care-as-usual was not statistically significant (-€318; 95% CI -1282 to 645).,"['insomnia patients in general practice over 26\xa0weeks from a societal perspective', 'Patients with Insomnia in General Practice']","['guided, internet-delivered CBT-I (i-Sleep', 'Guided Internet-Delivered Cognitive Behavioral Therapy', 'cognitive-behavioral therapy']","['Insomnia Severity Index (ISI, continuous score and clinically relevant response), and Quality-Adjusted Life Years (QALYs', 'Societal costs', 'societal costs', 'ISI score', 'cost-effectiveness planes and acceptability curves', 'insomnia severity symptoms', 'Cost-effectiveness']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",,0.0232733,The difference in societal costs between i-Sleep and care-as-usual was not statistically significant (-€318; 95% CI -1282 to 645).,"[{'ForeName': 'Agni', 'Initials': 'A', 'LastName': 'Baka', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'van der Zweerde', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, & Amsterdam Public Health Research Institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Lancee', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'van Straten', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, & Amsterdam Public Health Research Institute, Vrije Universiteit, Amsterdam, The Netherlands.'}]",Behavioral sleep medicine,['10.1080/15402002.2021.1901708']
499,33793979,Breast cancer patients' insurance status and residence zip code correlate with early discontinuation of endocrine therapy: An analysis of the ECOG-ACRIN TAILORx trial.,"BACKGROUND


Early discontinuation is a substantial barrier to the delivery of endocrine therapies (ETs) and may influence recurrence and survival. The authors investigated the association between early discontinuation of ET and social determinants of health, including insurance coverage and the neighborhood deprivation index (NDI), which was measured on the basis of patients' zip codes, in breast cancer.
METHODS


In this retrospective analysis of a prospective randomized clinical trial (Trial Assigning Individualized Options for Treatment), women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who started ET within a year of study entry were included. Early discontinuation was calculated as stopping ET within 4 years of its start for reasons other than distant recurrence or death via Kaplan-Meier estimates. A Cox proportional hazards joint model was used to analyze the association between early discontinuation of ET and factors such as the study-entry insurance and NDI, with adjustments made for other variables.
RESULTS


Of the included 9475 women (mean age, 55.6 years; White race, 84%), 58.0% had private insurance, whereas 11.7% had Medicare, 5.8% had Medicaid, 3.8% were self-pay, and 19.1% were treated at international sites. The early discontinuation rate was 12.3%. Compared with those with private insurance, patients with Medicaid (hazard ratio [HR], 1.53; 95% confidence interval [CI], 1.23-1.92) and self-pay patients (HR, 1.65; 95% CI, 1.25-2.17) had higher early discontinuation. Participants with a first-quartile NDI (highest deprivation) had a higher probability of discontinuation than those with a fourth-quartile NDI (lowest deprivation; HR, 1.34; 95% CI, 1.11-1.62).
CONCLUSIONS


Patients' insurance and zip code at study entry play roles in adherence to ET, with uninsured and underinsured patients having a high rate of treatment nonadherence. Early identification of patients at risk may improve adherence to therapy.
LAY SUMMARY


In this retrospective analysis of 9475 women with breast cancer participating in a clinical trial (Trial Assigning Individualized Options for Treatment), Medicaid and self-pay patients (compared with those with private insurance) and those in the highest quartile of neighborhood deprivation scores (compared with those in the lowest quartile) had a higher probability of early discontinuation of endocrine therapy. These social determinants of health assume larger importance with the expected increase in unemployment rates and loss of insurance coverage in the aftermath of the coronavirus disease 2019 pandemic. Early identification of patients at risk and enrollment in insurance optimization programs may improve the persistence of therapy.",2021,"Compared with those with private insurance, patients with Medicaid (hazard ratio [HR], 1.53; 95% confidence interval [CI], 1.23-1.92) and self-pay patients (HR, 1.65; 95% CI, 1.25-2.17) had higher early discontinuation.","['women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who started ET within a year of study entry were included', 'Of the included 9475 women (mean age, 55.6 years; White race, 84%), 58.0% had private insurance, whereas 11.7% had Medicare, 5.8% had Medicaid, 3.8% were self-pay, and 19.1% were treated at international sites', ""Breast cancer patients' insurance status and residence zip code correlate with early discontinuation of endocrine therapy"", '9475 women with breast cancer participating in a clinical trial (Trial Assigning Individualized Options for Treatment), Medicaid and self-pay patients (compared with those with private insurance']",[],"['unemployment rates and loss of insurance coverage', 'early discontinuation rate', 'neighborhood deprivation scores', 'probability of discontinuation', 'ET and social determinants of health, including insurance coverage and the neighborhood deprivation index (NDI', 'probability of early discontinuation of endocrine therapy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0453984', 'cui_str': 'Zipper'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3658315', 'cui_str': 'Social Determinants of Health'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]",9475.0,0.0700825,"Compared with those with private insurance, patients with Medicaid (hazard ratio [HR], 1.53; 95% confidence interval [CI], 1.23-1.92) and self-pay patients (HR, 1.65; 95% CI, 1.25-2.17) had higher early discontinuation.","[{'ForeName': 'Gelareh', 'Initials': 'G', 'LastName': 'Sadigh', 'Affiliation': 'Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'ECOG-ACRIN Biostatistics Center, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Yanez', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Sofia F', 'Initials': 'SF', 'LastName': 'Garcia', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Lava R', 'Initials': 'LR', 'LastName': 'Timsina', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford Cancer Center Palo Alto, Stanford, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Sciences, Winston-Salem, North Carolina.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'Carlos', 'Affiliation': 'University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan.'}]",Cancer,['10.1002/cncr.33527']
500,33797667,Relationship Between Mental Health and HIV Transmission Knowledge and Prevention Attitudes Among Adolescents Living with HIV: Lessons from Suubi + Adherence Cluster Randomized Study in Southern Uganda.,"We assessed the effect of depression, hopelessness, and self-concept on HIV prevention attitudes and knowledge about infection, transmission and sexual risk behavior among adolescents living with HIV in Uganda. Utilizing longitudinal data from 635 adolescents living with HIV, multiple ordinary least square regression was used to evaluate associations between the three indicators of mental health functioning at baseline and HIV knowledge and prevention attitudes at 12-months follow-up. We found that depression (β = - 0.17; 95% CI - 0.31, - 0.04) and hopelessness (β = - 0.16; 95% CI - 0.28, - 0.04) scores at baseline were associated with a 0.17 and 0.16 average reduction in HIV prevention attitudes and HIV knowledge scores, respectively at 12-months follow-up. However, self-concept was not significantly associated with HIV knowledge or prevention attitudes. Adolescents living with HIV with greater levels of hopelessness are at increased risk of having limited HIV knowledge while those with greater symptoms of depression had less favorable HIV prevention attitudes.",2021,"However, self-concept was not significantly associated with HIV knowledge or prevention attitudes.","['Adolescents living with HIV with greater levels of hopelessness', 'Adolescents Living with HIV', '635 adolescents living with HIV, multiple ordinary least square regression', 'Southern Uganda', 'adolescents living with HIV in Uganda']",[],"['HIV knowledge or prevention attitudes', 'Mental Health and HIV Transmission Knowledge and Prevention Attitudes', 'HIV prevention attitudes and knowledge about infection, transmission and sexual risk behavior', 'HIV prevention attitudes and HIV knowledge scores']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",635.0,0.116633,"However, self-concept was not significantly associated with HIV knowledge or prevention attitudes.","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA. byansiw@wustl.edu.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Brathwaite', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Calvert', 'Affiliation': 'Sargent College of Health and Rehabilitation Sciences, Boston University, Boston, MA, 02215, USA.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Namuwonge', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McKay', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Claude A', 'Initials': 'CA', 'LastName': 'Mellins', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute, Columbia University Medical Center, 1051 Riverside Drive, Box 15, New York, NY, 10032, USA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}]",AIDS and behavior,['10.1007/s10461-021-03243-7']
501,33789243,Effects of Caffeine on Performance During High- and Long-Jump Competitions.,"PURPOSE


To investigate the effects of caffeine (CAF) on performance during high- and long-jump competitions.
METHODS


Using a crossover and double-blind design, 6 well-trained high jumpers and 6 well-trained long jumpers performed a simulation of a high- and long-jump competition 60 minutes after ingesting a capsule containing either 5 mg·kg-1 body mass of anhydrous CAF or a placebo. The high jumps were video recorded for kinematic analysis. The velocity during the approach run of the long jump was also monitored using photocells.
RESULTS


CAF improved jump performance (ie, the highest bar height overlap increased by 5.1% [2.3%], P = .008), as well as enhancing the height displacement of the central body mass (+1.3% [1.7%], P = .004) compared with the placebo. CAF had no ergogenic effect on jump distance (P = .722); however, CAF increased the velocity during the last 10 m of the long jump (P = .019), and the percentage of ""foul jumps"" was higher than that expected by chance in the CAF group (80.5% [12.5%], χ2 = 13.44, P < .001) but not in the cellulose condition (58.3% [22.9%], χ2 = 1.48, P = .224).
CONCLUSION


CAF ingestion (5 mg·kg-1 body mass) improves high-jump performance but seems to negatively influence technical aspects during the approach run of the long jump, resulting in no improvement in long-jump performance. Thus, CAF can be useful for jumpers, but the specificity of the jump competition must be taken into account.",2021,"CAF had no ergogenic effect on jump distance (P = .722); however, CAF increased the velocity during the last 10 m of the long jump (P = .019), and the percentage of ""foul jumps"" was higher than that expected by chance in the CAF group (80.5% [12.5%], χ2 = 13.44, P < .001) but not in the cellulose condition (58.3% [22.9%], χ2 = 1.48, P",[],"['6 well-trained high jumpers and 6 well-trained long jumpers performed a simulation of a high- and long-jump competition 60\xa0minutes after ingesting a capsule containing either 5\xa0mg·kg-1 body mass of anhydrous CAF or a placebo', 'placebo', 'caffeine (CAF', 'Caffeine', 'CAF ingestion', 'CAF']","['jump distance', 'jump performance', 'height displacement of the central body mass', 'percentage of ""foul jumps', 'highest bar height overlap']",[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0542352', 'cui_str': 'Pullover'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}]",,0.0931742,"CAF had no ergogenic effect on jump distance (P = .722); however, CAF increased the velocity during the last 10 m of the long jump (P = .019), and the percentage of ""foul jumps"" was higher than that expected by chance in the CAF group (80.5% [12.5%], χ2 = 13.44, P < .001) but not in the cellulose condition (58.3% [22.9%], χ2 = 1.48, P","[{'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Santos-Mariano', 'Affiliation': ''}, {'ForeName': 'Fabiano', 'Initials': 'F', 'LastName': 'Tomazini', 'Affiliation': ''}, {'ForeName': 'Cintia', 'Initials': 'C', 'LastName': 'Rodacki', 'Affiliation': ''}, {'ForeName': 'Romulo', 'Initials': 'R', 'LastName': 'Bertuzzi', 'Affiliation': ''}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'De-Oliveira', 'Affiliation': ''}, {'ForeName': 'Adriano E', 'Initials': 'AE', 'LastName': 'Lima-Silva', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0755']
502,33785743,Peginterferon Lambda-1a for treatment of outpatients with uncomplicated COVID-19: a randomized placebo-controlled trial.,"Type III interferons have been touted as promising therapeutics in outpatients with coronavirus disease 2019 (COVID-19). We conducted a randomized, single-blind, placebo-controlled trial (NCT04331899) in 120 outpatients with mild to moderate COVID-19 to determine whether a single, 180 mcg subcutaneous dose of Peginterferon Lambda-1a (Lambda) within 72 hours of diagnosis could shorten the duration of viral shedding (primary endpoint) or symptoms (secondary endpoint). In both the 60 patients receiving Lambda and 60 receiving placebo, the median time to cessation of viral shedding was 7 days (hazard ratio [HR] = 0.81; 95% confidence interval [CI] 0.56 to 1.19). Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively, and symptom duration did not differ significantly between groups (HR 0.94; 95% CI 0.64 to 1.39). Both Lambda and placebo were well-tolerated, though liver transaminase elevations were more common in the Lambda vs. placebo arm (15/60 vs 5/60; p = 0.027). In this study, a single dose of subcutaneous Peginterferon Lambda-1a neither shortened the duration of SARS-CoV-2 viral shedding nor improved symptoms in outpatients with uncomplicated COVID-19.",2021,"Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively, and symptom duration did not differ significantly between groups (HR 0.94; 95% CI 0.64 to 1.39).","['60 patients receiving Lambda and 60 receiving', '120 outpatients with mild to moderate COVID-19 to determine whether a single, 180 mcg subcutaneous dose of Peginterferon Lambda-1a (Lambda) within 72 hours of diagnosis could shorten the duration of viral shedding (primary endpoint) or symptoms (secondary endpoint', 'outpatients with uncomplicated COVID-19', 'outpatients with coronavirus disease 2019 (COVID-19']","['placebo', 'Peginterferon Lambda-1a', 'subcutaneous Peginterferon Lambda-1a']","['symptom duration', 'median time to cessation of viral shedding', 'tolerated', 'liver transaminase elevations', 'duration of SARS-CoV-2 viral shedding nor improved symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1720314', 'cui_str': 'Lambda'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4043002', 'cui_str': 'peginterferon lambda-1a'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4043002', 'cui_str': 'peginterferon lambda-1a'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",120.0,0.505733,"Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively, and symptom duration did not differ significantly between groups (HR 0.94; 95% CI 0.64 to 1.39).","[{'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Jagannathan', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA. prasj@stanford.edu.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Andrews', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Bonilla', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Hedlin', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Jacobson', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Vidhya', 'Initials': 'V', 'LastName': 'Balasubramanian', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Purington', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Kamble', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Christiaan R', 'Initials': 'CR', 'LastName': 'de Vries', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Orlando', 'Initials': 'O', 'LastName': 'Quintero', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Feng', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ley', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Winslow', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Newberry', 'Affiliation': 'Department of Emergency Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Karlie', 'Initials': 'K', 'LastName': 'Edwards', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Hislop', 'Affiliation': 'Department of Pediatrics, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Choong', 'Affiliation': 'Department of Pediatrics, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Maldonado', 'Affiliation': 'Eiger BioPharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Glenn', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Bhatt', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Blish', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Taia', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Chaitan', 'Initials': 'C', 'LastName': 'Khosla', 'Affiliation': 'ChEM-H, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Pinsky', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Parsonnet', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Upinder', 'Initials': 'U', 'LastName': 'Singh', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA. usingh@stanford.edu.'}]",Nature communications,['10.1038/s41467-021-22177-1']
503,33798499,Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial.,"BACKGROUND


A new variant of SARS-CoV-2, B.1.1.7, emerged as the dominant cause of COVID-19 disease in the UK from November, 2020. We report a post-hoc analysis of the efficacy of the adenoviral vector vaccine, ChAdOx1 nCoV-19 (AZD1222), against this variant.
METHODS


Volunteers (aged ≥18 years) who were enrolled in phase 2/3 vaccine efficacy studies in the UK, and who were randomly assigned (1:1) to receive ChAdOx1 nCoV-19 or a meningococcal conjugate control (MenACWY) vaccine, provided upper airway swabs on a weekly basis and also if they developed symptoms of COVID-19 disease (a cough, a fever of 37·8°C or higher, shortness of breath, anosmia, or ageusia). Swabs were tested by nucleic acid amplification test (NAAT) for SARS-CoV-2 and positive samples were sequenced through the COVID-19 Genomics UK consortium. Neutralising antibody responses were measured using a live-virus microneutralisation assay against the B.1.1.7 lineage and a canonical non-B.1.1.7 lineage (Victoria). The efficacy analysis included symptomatic COVID-19 in seronegative participants with a NAAT positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to vaccine received. Vaccine efficacy was calculated as 1 - relative risk (ChAdOx1 nCoV-19 vs MenACWY groups) derived from a robust Poisson regression model. This study is continuing and is registered with ClinicalTrials.gov, NCT04400838, and ISRCTN, 15281137.
FINDINGS


Participants in efficacy cohorts were recruited between May 31 and Nov 13, 2020, and received booster doses between Aug 3 and Dec 30, 2020. Of 8534 participants in the primary efficacy cohort, 6636 (78%) were aged 18-55 years and 5065 (59%) were female. Between Oct 1, 2020, and Jan 14, 2021, 520 participants developed SARS-CoV-2 infection. 1466 NAAT positive nose and throat swabs were collected from these participants during the trial. Of these, 401 swabs from 311 participants were successfully sequenced. Laboratory virus neutralisation activity by vaccine-induced antibodies was lower against the B.1.1.7 variant than against the Victoria lineage (geometric mean ratio 8·9, 95% CI 7·2-11·0). Clinical vaccine efficacy against symptomatic NAAT positive infection was 70·4% (95% CI 43·6-84·5) for B.1.1.7 and 81·5% (67·9-89·4) for non-B.1.1.7 lineages.
INTERPRETATION


ChAdOx1 nCoV-19 showed reduced neutralisation activity against the B.1.1.7 variant compared with a non-B.1.1.7 variant in vitro, but the vaccine showed efficacy against the B.1.1.7 variant of SARS-CoV-2.
FUNDING


UK Research and Innovation, National Institute for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midlands NIHR Clinical Research Network, and AstraZeneca.",2021,Neutralising antibody responses were measured using a live-virus microneutralisation assay against the B.1.1.7 lineage and a canonical non-B.1.1.7 lineage (Victoria).,"['seronegative participants with a NAAT positive swab more than 14 days after a second dose of', '401 swabs from 311 participants were successfully sequenced', '8534 participants in the primary efficacy cohort, 6636 (78%) were aged 18-55 years and 5065 (59%) were female', 'Volunteers (aged ≥18 years) who were enrolled in phase 2/3 vaccine efficacy studies in the UK, and who were randomly assigned (1:1) to receive', 'Participants in efficacy cohorts were recruited between May 31 and Nov 13, 2020, and received booster doses between Aug 3 and Dec 30, 2020']","['ChAdOx1 nCoV-19 (AZD1222) vaccine', 'adenoviral vector vaccine, ChAdOx1 nCoV-19 (AZD1222', 'vaccine', 'ChAdOx1 nCoV-19 or a meningococcal conjugate control (MenACWY) vaccine, provided upper airway swabs']","['neutralisation activity', 'Vaccine efficacy', 'Neutralising antibody responses', 'Clinical vaccine efficacy against symptomatic NAAT positive infection', 'SARS-CoV-2 infection']","[{'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0183753', 'cui_str': 'Swab'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",311.0,0.536314,Neutralising antibody responses were measured using a live-virus microneutralisation assay against the B.1.1.7 lineage and a canonical non-B.1.1.7 lineage (Victoria).,"[{'ForeName': 'Katherine R W', 'Initials': 'KRW', 'LastName': 'Emary', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Golubchik', 'Affiliation': 'Big Data Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Parvinder K', 'Initials': 'PK', 'LastName': 'Aley', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cristina V', 'Initials': 'CV', 'LastName': 'Ariani', 'Affiliation': 'Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Angus', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sagida', 'Initials': 'S', 'LastName': 'Bibi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Blane', 'Affiliation': 'COVID-19 Genomics UK, Department of Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bonsall', 'Affiliation': 'Wellcome Centre for Human Genetics, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cicconi', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Charlton', 'Affiliation': 'National Infection Service, Public Health England, Salisbury, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Clutterbuck', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Collins', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine and Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Cox', 'Affiliation': 'UK Biocentre, Milton Keynes, UK.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Darton', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK; Department of Infection and Tropical Medicine, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dold', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Douglas', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher J A', 'Initials': 'CJA', 'LastName': 'Duncan', 'Affiliation': 'Department of Infection and Tropical Medicine, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Translational and Clinical Research Institute, Immunity and Inflammation Theme, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Katie J', 'Initials': 'KJ', 'LastName': 'Ewer', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Flaxman', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Daniela M', 'Initials': 'DM', 'LastName': 'Ferreira', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine and Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Finn', 'Affiliation': 'University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Fuskova', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Galiza', 'Affiliation': ""St George's Vaccine Institute, St George's, University of London, London, UK.""}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Goodman', 'Affiliation': ""Department of Infection, Guy's and St Thomas' NHS Foundation Trust, St Thomas' Hospital, London, UK; MRC Clinical Trials Unit, University College London, London, UK.""}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Green', 'Affiliation': 'Clinical BioManufacturing Facility, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Green', 'Affiliation': 'NIHR/Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Greenland', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Hallis', 'Affiliation': 'National Infection Service, Public Health England, Salisbury, UK.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Heath', 'Affiliation': ""St George's Vaccine Institute, St George's, University of London, London, UK.""}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Hay', 'Affiliation': 'University of Glasgow, Glasgow, UK; Lighthouse Laboratory in Glasgow, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine and Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jenkin', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kerridge', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rajeka', 'Initials': 'R', 'LastName': 'Lazarus', 'Affiliation': 'Severn Pathology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Libri', 'Affiliation': 'NIHR UCLH Clinical Research Facility, London, UK; NIHR UCLH Biomedical Research Centre, London, UK.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Lillie', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust, Hull, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ludden', 'Affiliation': 'COVID-19 Genomics UK, Department of Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Natalie G', 'Initials': 'NG', 'LastName': 'Marchevsky', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Minassian', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alastair C', 'Initials': 'AC', 'LastName': 'McGregor', 'Affiliation': 'London Northwest University Healthcare, Harrow, UK.'}, {'ForeName': 'Yama F', 'Initials': 'YF', 'LastName': 'Mujadidi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Phillips', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Plested', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katrina M', 'Initials': 'KM', 'LastName': 'Pollock', 'Affiliation': 'NIHR Imperial Clinical Research Facility, London, UK; NIHR Imperial Biomedical Research Centre, London, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'College of Medical, Veterinary & Life Sciences, Glasgow Dental Hospital and School, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Rinn', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Sutherland', 'Affiliation': 'Clinical Infection Research Group, Regional Infectious Diseases Unit, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Emma C', 'Initials': 'EC', 'LastName': 'Thomson', 'Affiliation': 'MRC University of Glasgow Centre for Virus Research, Glasgow, UK; Severn Pathology, North Bristol NHS Trust, Bristol, UK; Department of Infectious Diseases, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Toshner', 'Affiliation': 'Heart Lung Research Institute, Department of Medicine, University of Cambridge, Cambridge, UK; NIHR Cambridge Clinical Research Facility, Cambridge, UK; Cambridge University Hospital and Royal Papworth NHS Foundation Trusts, Cambridge, UK.'}, {'ForeName': 'David P J', 'Initials': 'DPJ', 'LastName': 'Turner', 'Affiliation': 'University of Nottingham, Nottingham, UK; Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vekemans', 'Affiliation': 'AstraZeneca BioPharmaceuticals, Gaithersburg, MD, USA.'}, {'ForeName': 'Tonya L', 'Initials': 'TL', 'LastName': 'Villafana', 'Affiliation': 'AstraZeneca BioPharmaceuticals, Gaithersburg, MD, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Williams', 'Affiliation': 'Public Health Wales, Cardiff, UK; Aneurin Bevan University Health Board, Newport, UK.'}, {'ForeName': 'Adrian V S', 'Initials': 'AVS', 'LastName': 'Hill', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Gilbert', 'Affiliation': 'Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Maheshi N', 'Initials': 'MN', 'LastName': 'Ramasamy', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK. Electronic address: maheshi.ramasamy@paediatrics.ox.ac.uk.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)00628-0']
504,33811730,Clinical outcomes after permanent polymer or polymer-free stent implantation in patients with diabetes mellitus: The ReCre8 diabetes substudy.,"OBJECTIVES


The purpose of this analysis was to compare target-lesion failure (TLF) of a permanent polymer zotarolimus-eluting stent (PP-ZES) versus a polymer-free amphilimus-eluting stent (PF-AES) in diabetics.
BACKGROUND


The improvement of outcomes with new-generation drug-eluting stent as seen in the general population is less pronounced among diabetics. The PF-AES introduces an elution-technology with potential enhanced performance in diabetics.
METHODS


In this subanalysis of the ReCre8 trial, patients were randomized to either a PP-ZES or PF-AES after stratification for diabetes and troponin status. The primary device-oriented endpoint was TLF, a composite of cardiac death, target-vessel myocardial infarction and target-lesion revascularization.
RESULTS


In the ReCre8 trial, 304 (20%) patients were diabetic and 96 (6%) had insulin-dependent diabetes mellitus. There was no statistically significant difference between the two study arms regarding the primary endpoint (PP-ZES 7.2% vs. PF-AES 4.0%; p = .21), although the composite of net adverse clinical events was higher in the PP-ZES arm (15.7 vs. 8.0%; p = .035). Stent thrombosis was low in both groups with no cases in the PP-ZES arm and 1 case in the PF-AES arm (p = .32). Regarding insulin-treated diabetics, TLF was higher in the PP-ZES arm (14.9 vs. 2.1%; p = .022).
CONCLUSIONS


Diabetics could potentially benefit from a dedicated stent, releasing sirolimus with a lipophilic carrier (amphilimus-formulation). Future trials should confirm the potential benefit of a PF-AES in this population.",2022,Stent thrombosis was low in both groups with no cases in the PP-ZES arm and 1 case in the PF-AES arm (p = .32).,"['304 (20%) patients were diabetic and 96 (6%) had insulin-dependent diabetes mellitus', 'patients with diabetes mellitus']","['polymer-free amphilimus-eluting stent (PF-AES', 'permanent polymer or polymer-free stent implantation', 'PP-ZES or PF-AES', 'new-generation drug-eluting stent', 'permanent polymer zotarolimus-eluting stent (PP-ZES']","['TLF, a composite of cardiac death, target-vessel myocardial infarction and target-lesion revascularization', 'composite of net adverse clinical events', 'Stent thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1700035', 'cui_str': 'Zotarolimus'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",304.0,0.198561,Stent thrombosis was low in both groups with no cases in the PP-ZES arm and 1 case in the PF-AES arm (p = .32).,"[{'ForeName': 'Nicole D', 'Initials': 'ND', 'LastName': 'van Hemert', 'Affiliation': 'Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Rozemeijer', 'Affiliation': 'Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Voskuil', 'Affiliation': 'Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Mèra', 'Initials': 'M', 'LastName': 'Stein', 'Affiliation': 'Department of Cardiology, Zuyderland Medical Center, Heerlen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Frambach', 'Affiliation': 'Department of Cardiology, National Institute of Cardiac Surgery and Interventional Cardiology, Luxembourg, Luxembourg.'}, {'ForeName': 'Saskia Z', 'Initials': 'SZ', 'LastName': 'Rittersma', 'Affiliation': 'Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Adriaan O', 'Initials': 'AO', 'LastName': 'Kraaijeveld', 'Affiliation': 'Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Geert E H', 'Initials': 'GEH', 'LastName': 'Leenders', 'Affiliation': 'Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'van der Harst', 'Affiliation': 'Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Pierfrancesco', 'Initials': 'P', 'LastName': 'Agostoni', 'Affiliation': 'Department of Cardiology, Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim, Antwerp, Belgium.'}, {'ForeName': 'Pieter R', 'Initials': 'PR', 'LastName': 'Stella', 'Affiliation': 'Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29685']
505,33812750,"Family Economic Empowerment, Family Social Support, and Sexual Risk-Taking Behaviors Among Adolescents Living With HIV in Uganda: The Suubi+Adherence Study.","PURPOSE


This study examined the effect of a family economic empowerment (EE) intervention and family support on sexual risk-taking behaviors among adolescents living with HIV in rural Uganda.
METHODS


We used data from the Suubi + Adherence study, a longitudinal cluster randomized clinical trial of 702 adolescents living with HIV aged 10-16 years. Participants were randomly assigned to either the control arm (n = 358) receiving bolstered standard of care or a treatment arm (n = 344) receiving bolstered standard of care plus the family EE intervention. We used mixed-effects models to examine the effect of the EE intervention and family support on sexual risk-taking behaviors at the baseline, 12 months, and 24 months after intervention initiation.
RESULTS


Adolescents in both the intervention and control groups did not differ significantly in their sexual risk-taking attitudes at the baseline and over the 24-month follow-up period. Higher levels of caregiver social support were significantly associated with a decrease in attitudes toward sexual risk-taking (ß = -.40, 95%CI = -.51, -.29). More frequent parent-child communication was significantly associated with increased negative sexual risk-taking attitudes (ß = .21, 95%CI = .16, .26).
CONCLUSIONS


Although we find no direct relationship between family EE and attitudes related to sexual risk-taking behaviors, we find that a supportive family environment can promote positive attitudes related to sexual risk-taking behaviors. The effectiveness of sexual risk reduction interventions would be enhanced by engaging families and strengthening supportive relationships between adolescents and their caregivers.",2021,"RESULTS


Adolescents in both the intervention and control groups did not differ significantly in their sexual risk-taking attitudes at the baseline and over the 24-month follow-up period.","['adolescents living with HIV in rural Uganda', '702 adolescents living with HIV aged 10-16\xa0years', 'Adolescents Living With HIV in Uganda', 'adolescents and their caregivers']","['control arm (n\xa0= 358) receiving bolstered standard of care or a treatment arm (n\xa0= 344) receiving bolstered standard of care plus the family EE intervention', 'family economic empowerment (EE) intervention and family support', 'sexual risk reduction interventions']","['negative sexual risk-taking attitudes', 'sexual risk-taking attitudes', 'attitudes toward sexual risk-taking (ß', 'sexual risk-taking behaviors', 'Higher levels of caregiver social support', 'Family Economic Empowerment, Family Social Support, and Sexual Risk-Taking Behaviors']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]",702.0,0.0586898,"RESULTS


Adolescents in both the intervention and control groups did not differ significantly in their sexual risk-taking attitudes at the baseline and over the 24-month follow-up period.","[{'ForeName': 'Thembekile', 'Initials': 'T', 'LastName': 'Shato', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Ucheoma', 'Initials': 'U', 'LastName': 'Nwaozuru', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Okumu', 'Affiliation': 'School of Social Work, University of North Carolina-Chapel, Chapel Hill, North Carolina.'}, {'ForeName': 'Massy', 'Initials': 'M', 'LastName': 'Mutumba', 'Affiliation': 'Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Brathwaite', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Masaka, Uganda.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Namuwonge', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Masaka, Uganda.'}, {'ForeName': 'Ozge Sensoy', 'Initials': 'OS', 'LastName': 'Bahar', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Division of Prevention Science, Center for AIDS Prevention Studies (CAPS), Department of Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, Missouri. Electronic address: fms1@wustl.edu.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2021.02.005']
506,33807319,Antenatal Determinants of Childhood Obesity in High-Risk Offspring: Protocol for the DiGest Follow-Up Study.,"Childhood obesity is an area of intense concern internationally and is influenced by events during antenatal and postnatal life. Although pregnancy complications, such as gestational diabetes and large-for-gestational-age birthweight have been associated with increased obesity risk in offspring, very few successful interventions in pregnancy have been identified. We describe a study protocol to identify if a reduced calorie diet in pregnancy can reduce adiposity in children to 3 years of age. The dietary intervention in gestational diabetes (DiGest) study is a randomised, controlled trial of a reduced calorie diet provided by a whole-diet replacement in pregnant women with gestational diabetes. Women receive a weekly dietbox intervention from enrolment until delivery and are blinded to calorie allocation. This follow-up study will assess associations between a reduced calorie diet in pregnancy with offspring adiposity and maternal weight and glycaemia. Anthropometry will be performed in infants and mothers at 3 months, 1, 2 and 3 years post-birth. Glycaemia will be assessed using bloodspot C-peptide in infants and continuous glucose monitoring with HbA1c in mothers. Data regarding maternal glycaemia in pregnancy, maternal nutrition, infant birthweight, offspring feeding behaviour and milk composition will also be collected. The DiGest follow-up study is expected to take 5 years, with recruitment finishing in 2026.",2021,"Although pregnancy complications, such as gestational diabetes and large-for-gestational-age birthweight have been associated with increased obesity risk in offspring, very few successful interventions in pregnancy have been identified.","['gestational diabetes (DiGest', 'infants and continuous glucose monitoring with HbA1c in mothers', 'pregnancy with offspring adiposity and maternal weight and glycaemia', 'children to 3 years of age', 'pregnant women with gestational diabetes']","['dietbox intervention', 'reduced calorie diet provided by a whole-diet replacement', 'dietary intervention', 'reduced calorie diet']","['Glycaemia', 'maternal glycaemia in pregnancy, maternal nutrition, infant birthweight, offspring feeding behaviour and milk composition']","[{'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1720845', 'cui_str': 'Maternal Nutritional Physiological Phenomenon'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",,0.0343703,"Although pregnancy complications, such as gestational diabetes and large-for-gestational-age birthweight have been associated with increased obesity risk in offspring, very few successful interventions in pregnancy have been identified.","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Emanuella', 'Initials': 'E', 'LastName': 'De Lucia Rolfe', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre-Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Rennie', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre-Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Linda M Oude', 'Initials': 'LMO', 'LastName': 'Griep', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre-Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Kusinski', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Hughes', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Soren', 'Initials': 'S', 'LastName': 'Brage', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Ken K', 'Initials': 'KK', 'LastName': 'Ong', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Beardsall', 'Affiliation': 'Department of Paediatric Medicine, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Meek', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK.'}]",Nutrients,['10.3390/nu13041156']
507,33811049,A two-arm parallel-group individually randomised prison pilot study of a male remand alcohol intervention for self-efficacy enhancement: the APPRAISE study protocol.,"INTRODUCTION


The prevalence of at-risk drinking is far higher among those in contact with the criminal justice system (73%) than the general population (35%). However, there is little evidence on the effectiveness of alcohol brief interventions (ABIs) in reducing risky drinking among those in the criminal justice system, including the prison system and, in particular, those on remand. Building on earlier work, A two-arm parallel group individually randomised Prison Pilot study of a male Remand Alcohol Intervention for Self-efficacy Enhancement (APPRAISE) is a pilot study designed to assess the feasibility and acceptability of an ABI, delivered to male prisoners on remand. The findings of APPRAISE should provide the information required to design a future definitive randomised controlled trial (RCT).
METHODS AND ANALYSIS


APPRAISE will use mixed methods, with two linked phases, across two prisons in the UK, recruiting 180 adult men on remand: 90 from Scotland and 90 from England. Phase I will involve a two-arm, parallel-group, individually randomised pilot study. The pilot evaluation will provide data on the likely impact of A two-arm parallel group individually randomised Prison Pilot study of a male Remand Alcohol Intervention for Self-efficacy Enhancement (APPRAISE), which will be used to inform a future definitive multicentre RCT. Phase II will be a process evaluation assessing how the ABI has been implemented to explore the change mechanisms underpinning the ABI (figure 1) and to assess the context within which the ABI is delivered.
ETHICS AND DISSEMINATION


The APPRAISE protocol has been approved by the East of Scotland Research Ethics Committee (19/ES/0068), National Offender Management System (2019-240), Health Board Research and Development (2019/0268), Scottish Prison Service research and ethics committee, and by the University of Edinburgh's internal ethics department. The findings will be disseminated via peer-reviewed journal publications, presentations at local, national and international conferences, infographics and shared with relevant stakeholders through meetings and events.
TRIAL REGISTRATION NUMBER


ISRCTN27417180.",2021,The prevalence of at-risk drinking is far higher among those in contact with the criminal justice system (73%) than the general population (35%).,"['male prisoners on remand', '180 adult men on remand: 90 from Scotland and 90 from England']","['alcohol brief interventions (ABIs', 'male remand alcohol intervention', 'male Remand Alcohol Intervention']","['prevalence of at-risk drinking', 'feasibility and acceptability']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0425170', 'cui_str': 'On remand'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C3494740', 'cui_str': 'Alcohol brief intervention'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",180.0,0.0637577,The prevalence of at-risk drinking is far higher among those in contact with the criminal justice system (73%) than the general population (35%).,"[{'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Holloway', 'Affiliation': 'School of Health in Social Science, University of Edinburgh, Edinburgh, UK Aisha.Holloway@ed.ac.uk.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Guthrie', 'Affiliation': 'School of Health in Social Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Waller', 'Affiliation': 'School of Social Sciences, Humanities & Law, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'School of Health in Social Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Boyd', 'Affiliation': 'School of Social Sciences, Humanities & Law, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Mercado', 'Affiliation': 'School of Health in Social Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'School of Health in Social Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Stenhouse', 'Affiliation': 'School of Health in Social Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Division of Community Health Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Richard Anthony', 'Initials': 'RA', 'LastName': 'Parker', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Stoddart', 'Affiliation': 'Edinburgh Health Services Research Unit, The University Of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Conaglen', 'Affiliation': 'Public Health Directorate, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Coulton', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, UK.'}, {'ForeName': 'Gertraud', 'Initials': 'G', 'LastName': 'Stadler', 'Affiliation': 'Institute for Gender Medicine, Charite Universitatsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hunt', 'Affiliation': 'Institute of Social Marketing, University of Stirling, Stirling, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bray', 'Affiliation': 'Department of Economics, University of North Carolina at Greensboro, Greensborough, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ferguson', 'Affiliation': 'School of Social Sciences, Humanities & Law, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sondhi', 'Affiliation': 'Therapeutic Solutions, London, UK.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Lynch', 'Affiliation': 'Criminal Justice, Alcohol, Drugs and Tobacco Division, Public Health England, London, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Rees', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Newbury-Birch', 'Affiliation': 'School of Social Sciences, Humanities & Law, Teesside University, Middlesbrough, UK.'}]",BMJ open,['10.1136/bmjopen-2020-040636']
508,33245618,"Your Path to Transplant: A randomized controlled trial of a tailored expert system intervention to increase knowledge, attitudes, and pursuit of kidney transplant.","Individually tailoring education over time may help more patients, especially racial/ethnic minorities, get waitlisted and pursue deceased and living donor kidney transplant (DDKT and LDKT, respectively). We enrolled 802 patients pursuing transplant evaluation at the University of California, Los Angeles Transplant Program into a randomized education trial. We compared the effectiveness of Your Path to Transplant (YPT), an individually tailored coaching and education program delivered at 4 time points, with standard of care (SOC) education on improving readiness to pursue DDKT and LDKT, transplant knowledge, taking 15 small transplant-related actions, and pursuing transplant (waitlisting or LDKT rates) over 8 months. Survey outcomes were collected prior to evaluation and at 4 and 8 months. Time to waitlisting or LDKT was assessed with at least 18 months of follow-up. At 8 months, compared to SOC, the YPT group demonstrated increased LDKT readiness (47% vs 33%, P = .003) and transplant knowledge (effect size [ES] = 0.41, P < .001). Transplant pursuit was higher in the YPT group (hazard ratio: 1.44, 95% confidence interval: 1.15-1.79, P = .002). A focused, coordinated education effort can improve transplant-seeking behaviors and waitlisting rates. ClinicalTrials.gov registration: NCT02181114.",2021,"Transplant pursuit was higher in the YPT group (hazard ratio: 1.44, 95% confidence interval: 1.15-1.79, P = .002).","['802 patients pursuing transplant evaluation at the University of California, Los Angeles Transplant Program into a randomized education trial', 'Your Path to Transplant']","['YPT', 'tailored expert system intervention', 'Your Path to Transplant (YPT), an individually tailored coaching and education program delivered at 4 time points, with standard of care (SOC) education on improving readiness to pursue DDKT and LDKT, transplant knowledge, taking 15 small transplant-related actions, and pursuing transplant (waitlisting or LDKT rates']","['LDKT readiness', 'transplant knowledge', 'transplant-seeking behaviors and waitlisting rates', 'knowledge, attitudes, and pursuit of kidney transplant', 'Time to waitlisting or LDKT', 'Transplant pursuit']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1141889', 'cui_str': 'Transplant evaluation'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0015324', 'cui_str': 'Expert Systems'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0441472', 'cui_str': 'Action'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",802.0,0.0353113,"Transplant pursuit was higher in the YPT group (hazard ratio: 1.44, 95% confidence interval: 1.15-1.79, P = .002).","[{'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Waterman', 'Affiliation': 'Division of Nephrology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Peipert', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Terasaki Institute of Biomedical Innovation, Los Angeles, California, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Beaumont', 'Affiliation': 'Terasaki Institute of Biomedical Innovation, Los Angeles, California, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Paiva', 'Affiliation': 'Department of Psychology, The University of Rhode Island, Kingston, Rhode Island, USA.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Lipsey', 'Affiliation': 'Division of Nephrology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Crystal S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'Division of Nephrology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Robbins', 'Affiliation': 'Department of Psychology, The University of Rhode Island, Kingston, Rhode Island, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16262']
509,33815732,Role of an e-Health Intervention in Holistic Healthcare: A Quasiexperiment in Patients Undergoing Cardiac Catheterization in Taiwan.,"Background


The use of electronic health (e-health) resources is emerging as an alternative method to improve the secondary prevention of coronary artery disease (CAD). The aim of this study was to describe the influence of an e-health application in holistic healthcare for patients with CAD.
Methods


A quasiexperiment with nonequivalent groups design recruited outpatients with a high risk of CAD admitted for cardiac catheterization. They were divided into two groups. Before the procedure, the control group received traditional patient education, and the intervention group watched videos on Internet-based social media. EQ-5D and FACIT-Sp-12 questionnaires were used as outcome measures of interest, and they were administered before and after the procedure and at the first return visit to the outpatient clinic after discharge. The effect of each intervention was tested using a linear mixed effects model. In addition, the 90-day readmission rate was also studied.
Results


A total of 300 patients were divided into intervention and control groups (150 patients in each group). The interaction effect of EQ-5D was not statistically significant; however, improvements in FACIT-Sp-12 were greater in the intervention group from baseline to before discharge (regression coefficient ( B ) = 1.70,  p  < 0.001) and from baseline to postdischarge first outpatient visit ( B  = 1.81,  p  < 0.001). Moreover, the 90-day readmission rate was significantly lower in the intervention group (14% vs. 18.7%;  p =0.016, log-rank test).
Conclusions


e-health intervention with easily accessible Internet-based social media is a promising model to meet the holistic needs of patients with CAD in the modern era.",2021,"The interaction effect of EQ-5D was not statistically significant; however, improvements in FACIT-Sp-12 were greater in the intervention group from baseline to before discharge (regression coefficient ( B ) = 1.70,  p  < 0.001) and from baseline to postdischarge first outpatient visit ( B  = 1.81,  p  < 0.001).","['Holistic Healthcare', 'patients with CAD', '300 patients', 'Patients Undergoing Cardiac Catheterization in Taiwan', 'outpatients with a high risk of CAD admitted for cardiac catheterization']","['e-Health Intervention', 'traditional patient education, and the intervention group watched videos on Internet-based social media', 'EQ-5D']","['90-day readmission rate', 'EQ-5D and FACIT-Sp-12 questionnaires', 'FACIT-Sp-12']","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",300.0,0.0131607,"The interaction effect of EQ-5D was not statistically significant; however, improvements in FACIT-Sp-12 were greater in the intervention group from baseline to before discharge (regression coefficient ( B ) = 1.70,  p  < 0.001) and from baseline to postdischarge first outpatient visit ( B  = 1.81,  p  < 0.001).","[{'ForeName': 'Jian-Rong', 'Initials': 'JR', 'LastName': 'Peng', 'Affiliation': 'Department of Cardiology, New Taipei Municipal TuCheng Hospital, Chang Gung Memorial Hospital, New Taipei, Taiwan.'}, {'ForeName': 'Hung-Chi', 'Initials': 'HC', 'LastName': 'Su', 'Affiliation': 'Department of Cardiology, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan.'}, {'ForeName': 'Chia-Pin', 'Initials': 'CP', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiology, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan.'}, {'ForeName': 'Chun-Chi', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan.'}, {'ForeName': 'Chi-Jen', 'Initials': 'CJ', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiology, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan.'}, {'ForeName': 'Siou-Ling', 'Initials': 'SL', 'LastName': 'Gong', 'Affiliation': 'Department of Cardiology, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan.'}, {'ForeName': 'Pao-Hsien', 'Initials': 'PH', 'LastName': 'Chu', 'Affiliation': 'Department of Cardiology, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan.'}]",Journal of healthcare engineering,['10.1155/2021/6692952']
510,33242998,Pharmacokinetics and Pharmacodynamics of Human Regular U-500 Insulin Administered via Continuous Subcutaneous Insulin Infusion Versus Subcutaneous Injection in Adults With Type 2 Diabetes and High-Dose Insulin Requirements.,"INTRODUCTION


Human regular U-500 insulin (U-500R) is approved for subcutaneous (SC) injection in patients with diabetes requiring >200 units/day of insulin. Here, pharmacokinetic and pharmacodynamic (PK/PD) profiles following U-500R administered by continuous subcutaneous insulin infusion (CSII) and SC injection in adults with type 2 diabetes (T2D) on high-dose insulin were studied.
METHODS


In this randomized, crossover, euglycemic clamp study, patients received a 100-unit bolus of U-500R via SC injection or CSII with basal infusion using a U-500R specific pump. PK parameters were estimated using non-compartmental methods. PD estimates were derived from the glucose infusion rate during the euglycemic clamp procedure.
RESULTS


When corrected for the basal infusion, the PK profiles for the 100-unit bolus of U-500R were similar for CSII and SC injection. Without correction for basal infusion, PK and PD profiles showed a greater insulin concentration and effect when U-500R was administered via CSII compared to SC injection, primarily due to basal insulin infusion for CSII. The ratio of geometric least squares AUC 0-tlast  means SC:CSII (90% CI) is 0.857 (0.729, 1.01) with correction (mean AUC 0-tlast : 5230 pmol*L/h [SC injection] and 6070 pmol*L/h [CSII, with correction]) and 0.424 (0.361, 0.499) without correction (mean AUC 0-tlast : 12300 pmol*L/h [CSII, without correction]). Median time-to-peak insulin concentration was six hours (range 0.5-8 hours) via SC injection and five hours (0.5-12 hours) via CSII.
CONCLUSIONS


In adults with T2D on high-dose insulin, U-500R PK/PD parameters were similar for a 100-unit bolus when given by SC injection or CSII via a U-500R pump.",2022,"When corrected for the basal infusion, the PK profiles for the 100-unit bolus of U-500R were similar for CSII and SC injection.","['adults with type 2 diabetes (T2D) on high-dose insulin were studied', 'patients with diabetes requiring >200 units/day of insulin', 'Adults With Type 2 Diabetes and High-Dose Insulin Requirements']","['Human regular U-500 insulin (U-500R', '6070 pmol*L/h [CSII, with correction', 'U-500R via SC injection or CSII with basal infusion using a U-500R specific pump', 'Human Regular U-500 Insulin Administered via Continuous Subcutaneous Insulin Infusion', 'U-500R administered by continuous subcutaneous insulin infusion (CSII) and SC injection']","['glucose infusion rate', 'Median time-to-peak insulin concentration', 'PK parameters']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0456683', 'cui_str': 'U/day'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0875028,"When corrected for the basal infusion, the PK profiles for the 100-unit bolus of U-500R were similar for CSII and SC injection.","[{'ForeName': 'Xiaosu', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Charles T', 'Initials': 'CT', 'LastName': 'Benson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Prescilla', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Linnebjerg', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'LaBell', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Morrow', 'Affiliation': 'ProSciento Incorporated, Chula Vista, CA, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Jackson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Insulet Corporation, Acton, MA, USA.'}, {'ForeName': 'Liza L', 'Initials': 'LL', 'LastName': 'Ilag', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jennal L', 'Initials': 'JL', 'LastName': 'Johnson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Leishman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Journal of diabetes science and technology,['10.1177/1932296820972719']
511,33814847,Randomized controlled trial comparing the efficacy of pectoral nerve block with general anesthesia alone in patients undergoing unilateral mastectomy.,"This study was conducted to evaluate the efficacy of pectoral nerve block for post-operative analgesia in breast surgery patients. This double blinded, randomized controlled trial was conducted after Clinical Trials Registry-India registration. Sixty ASA grade I-II female patients undergoing unilateral modified radical mastectomy under general anesthesia, were recruited pre-operatively in two groups. PECS group ( n   =  29) was given ipsilateral pectoral nerve block I & II while the CONTROL group ( n   =  29) directly proceeded to surgery. Our primary outcome was comparison of immediate post-operative pain scores at rest and movement. The secondary outcomes were post-operative pain scores at 2, 4, 6, 12, 18, and 24 h, total intraoperative fentanyl consumption, time to rescue analgesia, post-operative nausea vomiting, and complications, if any. Categorical data was analyzed by using the chi-squared test or Fishers Exact test. Comparison of pain scores was analyzed by using the Independent sample  t  test. The immediate post-operative pain scores in two groups were comparable. The pain scores were also comparable at 4, 6, 12, and 24 h; but statistically significantly lower in PECS group at 2 and 18 h. The total intraoperative fentanyl consumption was also reduced in PECS group ( P  = 0.009). Only 9 patients in PECS group (796.5 min) as compared to 22 patients in CONTROL group (387.7 min) required rescue analgesia ( P   =  0.001). Pectoral nerve block benefits patients undergoing mastectomy by achieving similar post-operative pain scores with decreased consumption of intraoperative and post-operative opioids. Registration. Clinical Trials Registry of India, (CTRI/2017/04/008289). ctri.nic.in.",2021,The total intraoperative fentanyl consumption was also reduced in PECS group ( P  = 0.009).,"['I-II female patients undergoing unilateral modified radical mastectomy under general anesthesia', 'breast surgery patients', 'Sixty ASA grade', 'patients undergoing unilateral mastectomy']","['pectoral nerve block with general anesthesia alone', 'PECS', 'pectoral nerve block']","['24\xa0h, total intraoperative fentanyl consumption, time to rescue analgesia, post-operative nausea vomiting, and complications, if any', 'immediate post-operative pain scores at rest and movement', 'pain scores', 'immediate post-operative pain scores', 'post-operative pain scores', 'rescue analgesia', 'total intraoperative fentanyl consumption']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0024886', 'cui_str': 'Simple mastectomy'}]","[{'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0055065', 'cui_str': 'CEP combination'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.565637,The total intraoperative fentanyl consumption was also reduced in PECS group ( P  = 0.009).,"[{'ForeName': 'Sudivya', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Anaesthesia Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, 400012 Mumbai, India.'}, {'ForeName': 'Shashank', 'Initials': 'S', 'LastName': 'Tiwari', 'Affiliation': 'Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'Kailash', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'Department of Anaesthesia Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, 400012 Mumbai, India.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Nair', 'Affiliation': 'Department Of Surgical Oncology (Breast Services), Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}]",Indian journal of surgical oncology,['10.1007/s13193-020-01269-2']
512,33814842,A Prospective Study on Metronomic Scheduling of Non-chemotherapeutic Drugs in Advanced Epithelial Ovarian Cancers.,"The objectives of this study are to assess the role of non-chemotherapeutic combination of drugs as maintenance therapy, after standard treatment, for advanced epithelial ovarian cancers (EOC) and to determine the recurrence-free survival (RFS) and cancer-specific survival (CSS). One hundred women with advanced high-grade EOC who had completed standard treatment by primary/interval debulking surgery followed by adjuvant chemotherapy were randomised to either receive (study group) or not to receive (control group) the non-chemotherapeutic maintenance therapy (oral metformin, anastrozole, aspirin, atorvastatin, vitamin D, injection zoledronic acid). Both groups were followed up, and trends of RFS and CSS were analysed. One hundred patients were analysed. Median RFS was 18 months (95% CI: 13-24) in study group versus 16 (95% CI: 14-20) in the control group ( P  value = 0.57). Median CSS in the study group was lesser than that in the control group (47 months (95% CI: 31-68) versus 51 (95% CI: 32-66),  P  value = 0.76). Five-year CSS was not significantly different between the groups (47% study vs 40% control,  P  value = 0.51). The use of combination of non-chemotherapeutic drugs as maintenance therapy was found to have no significant impact on the survival or reduction of recurrences in patients with advanced epithelial ovarian cancer.
Supplementary Information


The online version contains supplementary material available at 10.1007/s13193-020-01261-w.",2021,"Five-year CSS was not significantly different between the groups (47% study vs 40% control,  P  value = 0.51).","['advanced epithelial ovarian cancers (EOC', 'Advanced Epithelial Ovarian Cancers', 'One hundred women with advanced high-grade EOC who had completed standard treatment by primary/interval debulking surgery followed by adjuvant chemotherapy', 'patients with advanced epithelial ovarian cancer', 'One hundred patients were analysed']","['Metronomic Scheduling of Non-chemotherapeutic Drugs', 'not to receive (control group) the non-chemotherapeutic maintenance therapy (oral metformin, anastrozole, aspirin, atorvastatin, vitamin D, injection zoledronic acid']","['Median CSS', 'recurrence-free survival (RFS) and cancer-specific survival (CSS', 'Median RFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",100.0,0.208763,"Five-year CSS was not significantly different between the groups (47% study vs 40% control,  P  value = 0.51).","[{'ForeName': 'Shruthi', 'Initials': 'S', 'LastName': 'Shivdas', 'Affiliation': 'Department of Gynaecologic Oncology, Kidwai Memorial Institute of Oncology campus, No. 5, AB Type, Block- 1, Dr M H Marigowda Road, Bangalore, 560029 India.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rajatharangani', 'Affiliation': 'Department of Gynaecologic Oncology, Kidwai Memorial Institute of Oncology campus, No. 5, AB Type, Block- 1, Dr M H Marigowda Road, Bangalore, 560029 India.'}, {'ForeName': 'Praveen S', 'Initials': 'PS', 'LastName': 'Rathod', 'Affiliation': 'Department of Gynaecologic Oncology, Kidwai Memorial Institute of Oncology campus, No. 5, AB Type, Block- 1, Dr M H Marigowda Road, Bangalore, 560029 India.'}, {'ForeName': 'V R', 'Initials': 'VR', 'LastName': 'Pallavi', 'Affiliation': 'Department of Gynaecologic Oncology, Kidwai Memorial Institute of Oncology campus, No. 5, AB Type, Block- 1, Dr M H Marigowda Road, Bangalore, 560029 India.'}, {'ForeName': 'Uttam D', 'Initials': 'UD', 'LastName': 'Bafna', 'Affiliation': 'Department of Gynaecologic Oncology, Kidwai Memorial Institute of Oncology campus, No. 5, AB Type, Block- 1, Dr M H Marigowda Road, Bangalore, 560029 India.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Vijay', 'Affiliation': 'Department of Biostatistics, Kidwai Memorial Institute of Oncology, Bangalore, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shobha', 'Affiliation': 'Department of Gynaecologic Oncology, Kidwai Memorial Institute of Oncology campus, No. 5, AB Type, Block- 1, Dr M H Marigowda Road, Bangalore, 560029 India.'}, {'ForeName': 'Rajashekar', 'Initials': 'R', 'LastName': 'Kundargi', 'Affiliation': 'Department of Gynaecologic Oncology, Kidwai Memorial Institute of Oncology campus, No. 5, AB Type, Block- 1, Dr M H Marigowda Road, Bangalore, 560029 India.'}]",Indian journal of surgical oncology,['10.1007/s13193-020-01261-w']
513,33814840,Sensory Changes and Postmastectomy Pain Following Preservation of Intercostobrachial Nerve in Breast Cancer Surgery: a Prospective Randomized Study.,"Surgery for breast cancer leads to sensory changes and persistent pain in about 20-60% of patients and is usually attributed to section of the intercostobrachial nerve (ICBN). However, the opinion is divided about the benefit of preservation of ICBN. Hence, this study was designed to assess the role of preservation of ICBN on sensory changes and acute and persistent pain following mastectomy. The study was conducted on patients undergoing modified radical mastectomy for breast cancer. At the time of surgery, ICBN was sacrificed in group I ( N  = 29), and preserved in group II ( N  = 24). Patients underwent sensory assessment for touch and pain in predefined areas after surgery. They were also assessed for acute post-operative pain and persistent pain (PP) on day 30 and 90 by numeric pain rating scale. PP was also evaluated by douleur neuropathique 4 questionnaire for assessment of its neuropathic character. Preservation of ICBN resulted in significantly better preserved sensation on lateral aspect of mastectomy incision, axilla, and medial aspect of the arm. Frequency and severity of acute post-operative pain were similar between the two groups. However, PP was significantly reduced in ICBN preserved group. At 3 months, 31% patients in group I and 12.5% in group II had clinically significant pain ( p  = 0.024). DN 4 assessment showed neuropathic character of pain in 20.6% and 8.33% in group I and II respectively. In our study, preservation of ICBN resulted in reduced rates of sensory loss and persistent neuropathic pain.",2021,DN 4 assessment showed neuropathic character of pain in 20.6% and 8.33% in group I and II respectively.,"['Breast Cancer Surgery', 'patients undergoing modified radical mastectomy for breast cancer']",['ICBN'],"['sensory loss and persistent neuropathic pain', 'neuropathic character of pain', 'lateral aspect of mastectomy incision, axilla, and medial aspect of the arm', 'acute post-operative pain and persistent pain (PP', 'Frequency and severity of acute post-operative pain', 'PP', 'Sensory Changes and Postmastectomy Pain', 'numeric pain rating scale', 'sensory changes and acute and persistent pain', 'clinically significant pain', 'sensory changes and persistent pain']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}]","[{'cui': 'C0228894', 'cui_str': 'Structure of intercostobrachial nerve'}]","[{'cui': 'C0278134', 'cui_str': 'Absence of sensation'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0423608', 'cui_str': 'Pain character'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0457821', 'cui_str': 'Mastectomy incision'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",,0.0301186,DN 4 assessment showed neuropathic character of pain in 20.6% and 8.33% in group I and II respectively.,"[{'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Kaur', 'Affiliation': 'Department of Surgery, UCMS & GTB Hospital University of Delhi, Dilshad Garden, Delhi, 110095 India.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Surgery, UCMS & GTB Hospital University of Delhi, Dilshad Garden, Delhi, 110095 India.'}, {'ForeName': 'Ayush', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Department of Surgery, UCMS & GTB Hospital University of Delhi, Dilshad Garden, Delhi, 110095 India.'}, {'ForeName': 'Ashok Kumar', 'Initials': 'AK', 'LastName': 'Saxena', 'Affiliation': 'Department of Anesthesia and critical care, UCMS & GTB Hospital, Delhi, India.'}]",Indian journal of surgical oncology,['10.1007/s13193-020-01193-5']
514,33783399,Combined Oxytocin and Cognitive Behavioral Social Skills Training for Social Function in People With Schizophrenia.,"BACKGROUND


A significant proportion of people with schizophrenia are characterized by impaired ability to socially engage with others. The development of effective interventions for social functioning remains a central therapeutic challenge. Cognitive-behavioral social skills training (CBSST) has been found to improve social functioning in schizophrenia, but with only medium effect sizes. Intranasal oxytocin also has prosocial effects, but also only with modest effect sizes. This study assessed whether the addition of intranasal oxytocin to CBSST can strengthen their impact on social function.
METHODS


Participants (N = 62) with schizophrenia or schizoaffective disorder entered a 24-week, double-blind, placebo-controlled, randomized clinical trial with a 3-month follow-up evaluation at 2 sites: Maryland and San Diego. Participants were randomized to either intranasal oxytocin 36 IU (3 sprays) twice a day (n = 31) or intranasal placebo-oxytocin (3 sprays) twice a day (n = 31). All participants received CBSST plus a social cognition skills training module (48 total sessions).
RESULTS


There were no significant treatment group differences in social functioning, positive symptoms, negative symptoms, defeatist beliefs, or asocial beliefs. The interpretation of treatment effects was complicated by site effects, whereby participants in San Diego began the trial with greater severity of impairments and subsequently showed greater improvements compared with participants in Maryland.
CONCLUSIONS


The results did not support the utility of add-on intranasal oxytocin to psychosocial rehabilitation interventions like CBSST for improvement in social function (ClinicalTrials.gov trial number: NCT01752712).",2021,The results did not support the utility of add-on intranasal oxytocin to psychosocial rehabilitation interventions like CBSST for improvement in social function (ClinicalTrials.gov trial number: NCT01752712).,"['Participants (N = 62) with schizophrenia or schizoaffective disorder', 'People With Schizophrenia']","['Cognitive-behavioral social skills training (CBSST', 'Combined Oxytocin and Cognitive Behavioral Social Skills Training', 'intranasal placebo-oxytocin', 'intranasal oxytocin', 'Intranasal oxytocin', 'placebo', 'CBSST plus a social cognition skills training module', 'Maryland and San Diego']","['social functioning, positive symptoms, negative symptoms, defeatist beliefs, or asocial beliefs']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150777', 'cui_str': 'Social skills training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",62.0,0.104902,The results did not support the utility of add-on intranasal oxytocin to psychosocial rehabilitation interventions like CBSST for improvement in social function (ClinicalTrials.gov trial number: NCT01752712).,"[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Buchanan', 'Affiliation': 'From the Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Deanna L', 'Initials': 'DL', 'LastName': 'Kelly', 'Affiliation': 'From the Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Strauss', 'Affiliation': 'Department of Psychology, University of Georgia, Athens, GA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Gold', 'Affiliation': 'From the Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Weiner', 'Affiliation': 'From the Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Zaranski', 'Affiliation': 'From the Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'From the Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Blatt', 'Affiliation': 'From the Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Holden', 'Affiliation': 'Veterans Affairs San Diego Healthcare System; Department of Psychiatry, University of California, San Diego School of Medicine, San Diego, CA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Granholm', 'Affiliation': 'Veterans Affairs San Diego Healthcare System; Department of Psychiatry, University of California, San Diego School of Medicine, San Diego, CA.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001397']
515,33814831,Flap Fixation as a Technique for Reducing Seroma Formation in Patients Undergoing Modified Radical Mastectomy: an Institutional Experience.,"Formation of seroma most frequently occurs after mastectomy and axillary surgery. This study is intended at creating data on whether flap fixation has any role in reducing the seroma formation in patients undergoing the modified radical mastectomy. A prospective comparative study was conducted among 61 patients scheduled for modified radical mastectomy from 1st of January 2017 to 31st of December 2017. Patients were divided into two groups. In the flap fixation group ( N  = 30), the skin flaps were sutured to the pectoral muscle with Vicryl 3-0 sutures, and in the control group ( N  = 31), the wound was closed in the conventional methods at the edges. Closed suction drain was used in both groups. Flap fixation group showed a significantly lower frequency of seroma formation compared with the control group. In the flap fixation group, the drain was removed earlier compared with the control group. Mean value of the total amount of fluid drained for the study group was significantly lower than that of control. Flap fixation is a surgical technique which appears to reduce the total volume of fluid drained, the development of seroma, and the need for seroma aspirations.",2021,Flap fixation group showed a significantly lower frequency of seroma formation compared with the control group.,"['Patients Undergoing Modified Radical Mastectomy', '61 patients scheduled for modified radical mastectomy from 1st of January 2017 to 31st of December 2017', 'patients undergoing the modified radical mastectomy']","['flap fixation', 'Closed suction drain', 'Flap fixation', 'Flap Fixation']","['frequency of seroma formation', 'seroma formation', 'Seroma Formation', 'Mean value of the total amount of fluid drained']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205435', 'cui_str': 'First'}]","[{'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0441139', 'cui_str': 'Suction drain'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}]",61.0,0.0451452,Flap fixation group showed a significantly lower frequency of seroma formation compared with the control group.,"[{'ForeName': 'Ajith', 'Initials': 'A', 'LastName': 'Vettuparambil', 'Affiliation': 'Department of surgery, DM Wayanad Institute of Medical Sciences, Wayanad, Kerala 673577 India.'}, {'ForeName': 'Chandrashekar', 'Initials': 'C', 'LastName': 'Subramanya', 'Affiliation': 'Department of General Surgery, Mysore Medical College and Research Institute, Mysore, Karnataka 570001 India.'}]",Indian journal of surgical oncology,['10.1007/s13193-020-01220-5']
516,33782086,"Myo -Inositol, Probiotics, and Micronutrient Supplementation From Preconception for Glycemia in Pregnancy: NiPPeR International Multicenter Double-Blind Randomized Controlled Trial.","OBJECTIVE


Better preconception metabolic and nutritional health are hypothesized to promote gestational normoglycemia and reduce preterm birth, but evidence supporting improved outcomes with nutritional supplementation starting preconception is limited.
RESEARCH DESIGN AND METHODS


This double-blind randomized controlled trial recruited from the community 1,729 U.K., Singapore, and New Zealand women aged 18-38 years planning conception. We investigated whether a nutritional formulation containing  myo -inositol, probiotics, and multiple micronutrients (intervention), compared with a standard micronutrient supplement (control), taken preconception and throughout pregnancy could improve pregnancy outcomes. The primary outcome was combined fasting, 1-h, and 2-h postload glycemia (28 weeks gestation oral glucose tolerance test).
RESULTS


Between 2015 and 2017, participants were randomized to control ( n  = 859) or intervention ( n  = 870); 585 conceived within 1 year and completed the primary outcome (295 intervention, 290 control). In an intention-to-treat analysis adjusting for site, ethnicity, and preconception glycemia with prespecified  P  < 0.017 for multiplicity, there were no differences in gestational fasting, 1-h, and 2-h glycemia between groups (β [95% CI] log e  mmol/L intervention vs. control -0.004 [-0.018 to 0.011], 0.025 [-0.014 to 0.064], 0.040 [0.004-0.077], respectively). Between the intervention and control groups there were no significant differences in gestational diabetes mellitus (24.8% vs. 22.6%, adjusted risk ratio [aRR] 1.22 [0.92-1.62]), birth weight (adjusted β = 0.05 kg [-0.03 to 0.13]), or gestational age at birth (mean 39.3 vs. 39.2 weeks, adjusted β = 0.20 [-0.06 to 0.46]), but there were fewer preterm births (5.8% vs. 9.2%, aRR 0.43 [0.22-0.82]), adjusting for prespecified covariates.
CONCLUSIONS


Supplementation with  myo -inositol, probiotics, and micronutrients preconception and in pregnancy did not lower gestational glycemia but did reduce preterm birth.",2021,"Between the intervention and control groups there were no significant differences in gestational diabetes mellitus (24.8% vs. 22.6%, adjusted risk ratio [aRR] 1.22 [0.92-1.62]), birth weight (adjusted β = 0.05 kg [-0.03 to 0.13]), or gestational age at birth (mean 39.3 vs. 39.2 weeks, adjusted β = 0.20 [-0.06 to 0.46]), but there were fewer preterm births (5.8% vs. 9.2%, aRR 0.43 [0.22-0.82]), adjusting for prespecified covariates.
","['Between 2015 and 2017', 'community 1,729 U.K., Singapore, and New Zealand women aged 18-38 years planning conception']","['Myo -Inositol, Probiotics, and Micronutrient Supplementation From Preconception', 'nutritional formulation containing  myo -inositol, probiotics, and multiple micronutrients (intervention), compared with a standard micronutrient supplement (control), taken preconception and throughout pregnancy']","['birth weight', 'gestational diabetes mellitus', 'preterm births', 'combined fasting, 1-h, and 2-h postload glycemia (28 weeks gestation oral glucose tolerance test', 'gestational fasting, 1-h, and 2-h glycemia', 'preterm birth', 'gestational glycemia']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0009637', 'cui_str': 'Conception'}]","[{'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}]",,0.79278,"Between the intervention and control groups there were no significant differences in gestational diabetes mellitus (24.8% vs. 22.6%, adjusted risk ratio [aRR] 1.22 [0.92-1.62]), birth weight (adjusted β = 0.05 kg [-0.03 to 0.13]), or gestational age at birth (mean 39.3 vs. 39.2 weeks, adjusted β = 0.20 [-0.06 to 0.46]), but there were fewer preterm births (5.8% vs. 9.2%, aRR 0.43 [0.22-0.82]), adjusting for prespecified covariates.
","[{'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, U.K. kmg@mrc.soton.ac.uk.'}, {'ForeName': 'Sheila J', 'Initials': 'SJ', 'LastName': 'Barton', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, U.K.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'El-Heis', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, U.K.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Kenealy', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Nield', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, U.K.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Baker', 'Affiliation': 'College of Life Sciences, Biological Sciences and Psychology, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Yap Seng', 'Initials': 'YS', 'LastName': 'Chong', 'Affiliation': 'Department of Obstetrics and Gynaecology, Yong Loo Lin School of Medicine, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Cutfield', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Shiao-Yng', 'Initials': 'SY', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-2515']
517,33246911,Long-term azithromycin use is not associated with QT prolongation in children with cystic fibrosis.,"Chronic Azithromycin (AZM) is a common treatment for lung infection. Among adults at risk of cardiac events, AZM use has been associated with cardiovascular harm. We assessed cardiovascular safety of AZM among children with CF, as a secondary analysis of a placebo-controlled, clinical trial, in which study drug was taken thrice-weekly for a planned 18 months. Safety assessments using electrocardiogram (ECG) occurred at study enrollment, and then after 3 weeks and 18 months of participation. Among 221 study participants with a median of 18 months follow-up, increased corrected QT interval (QTc) of ≥30 msec was rare, at 3.4 occurrences per 100 person-years; and incidence of QTc prolongation was no higher in the AZM arm than the placebo arm (1.8 versus 5.4 per 100 person-years). No persons experienced QTc intervals above 500 msec. Long-term chronic AZM use was not associated with increased QT prolongation.",2021,Long-term chronic AZM use was not associated with increased QT prolongation.,"['children with CF', 'children with cystic fibrosis']","['azithromycin', 'Chronic Azithromycin (AZM', 'placebo']","['incidence of QTc prolongation', 'corrected QT interval (QTc', 'QT prolongation', 'QTc intervals', 'cardiovascular safety of AZM', 'Safety assessments using electrocardiogram (ECG']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0855333', 'cui_str': 'Electrocardiogram QT corrected interval prolonged'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",221.0,0.146974,Long-term chronic AZM use was not associated with increased QT prolongation.,"[{'ForeName': 'Amalia S', 'Initials': 'AS', 'LastName': 'Magaret', 'Affiliation': ""Division of Pulmonary and Sleep Medicine, Department of Pediatrics, University of Washington, Seattle, WA, United States; Department of Biostatistics, University of Washington, Seattle, WA, United States; Seattle Children's Hospital, Seattle, WA, United States. Electronic address: amag@uw.edu.""}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Salerno', 'Affiliation': ""Division of Pulmonary and Sleep Medicine, Department of Pediatrics, University of Washington, Seattle, WA, United States; Seattle Children's Hospital, Seattle, WA, United States.""}, {'ForeName': 'Jason F', 'Initials': 'JF', 'LastName': 'Deen', 'Affiliation': ""Division of Cardiology, Department of Medicine, University of Washington, Seattle, WA, United States; Seattle Children's Hospital, Seattle, WA, United States.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kloster', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA, United States.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mayer-Hamblett', 'Affiliation': ""Division of Pulmonary and Sleep Medicine, Department of Pediatrics, University of Washington, Seattle, WA, United States; Department of Biostatistics, University of Washington, Seattle, WA, United States; Seattle Children's Hospital, Seattle, WA, United States.""}, {'ForeName': 'Bonnie W', 'Initials': 'BW', 'LastName': 'Ramsey', 'Affiliation': ""Division of Pulmonary and Sleep Medicine, Department of Pediatrics, University of Washington, Seattle, WA, United States; Seattle Children's Hospital, Seattle, WA, United States.""}, {'ForeName': 'Dave P', 'Initials': 'DP', 'LastName': 'Nichols', 'Affiliation': ""Division of Pulmonary and Sleep Medicine, Department of Pediatrics, University of Washington, Seattle, WA, United States; Seattle Children's Hospital, Seattle, WA, United States.""}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.11.005']
518,33780529,Recruitment and Screening Methods in Alzheimer's Disease Research: The FIT-AD Trial.,"BACKGROUND


Recruiting older adults with Alzheimer's disease (AD) dementia into clinical trials is challenging requiring multiple approaches. We describe recruitment and screening processes and results from the Functional Improvement from Aerobic Training in Alzheimer's Disease study (FIT-AD Trial), a single-site, pilot randomized controlled trial testing the effects of a 6-month aerobic exercise intervention on cognition and hippocampal volume in community-dwelling older adults with mild-to-moderate AD dementia.
METHODS


Ten recruitment strategies and a 4-step screening process were used to ensure a homogenous sample and exercise safety. The initial target sample was 90 participants over 48 months which was increased to 96 to allow those in the screening process to enroll if qualified. A tertiary analysis of recruitment and screening rates, recruitment yields and costs, and demographic characteristics of participants was conducted.
RESULTS


During the 48-month recruiting period, 396 potential participants responded to recruitment efforts, 301 individuals were reached and 103 were tentatively qualified. Of these, 67 (69.8%) participants completed the optional magnetic resonance imaging and 7 were excluded due to abnormal magnetic resonance imaging findings. As a result, we enrolled 96 participants with a 2.92 screen ratio, 2.14 recruitment rate, and 31.9% recruitment yield. Referrals (28.1%) and Alzheimer's Association events/services (21.9%) yielded over 49% of the enrolled participants. Total recruitment cost was $38 246 or $398 per randomized participant.
CONCLUSIONS


A multiprong approach involving extensive community outreach was essential in recruiting older adults with AD dementia into a single-site trial. For every randomized participant, 3 individuals needed to be screened. Referrals were the most cost-effective recruitment strategy. Clinical Trials Registration Number: NCT0194550.",2022,Referrals were the most cost-effective recruitment strategy.,"['community-dwelling older adults with mild-to moderate AD dementia', ""Alzheimer's Disease Research"", ""older adults with Alzheimer's disease (AD) dementia"", 'older adults with AD dementia into a single-site trial', '67 (69.8%) participants completed the optional magnetic resonance (MRI) imaging and seven were excluded due to abnormal MRI findings', '396 potential participants responded to recruitment efforts, 301 individuals were reached and 103 were tentatively qualified', '96 participants with a 2.92 screen ratio, 2.14 recruitment rate, and 31.9% recruitment yield']",['aerobic exercise intervention'],"['Total recruitment cost', 'cognition and hippocampal volume']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0436540', 'cui_str': 'MRI scan abnormal'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",96.0,0.717902,Referrals were the most cost-effective recruitment strategy.,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Greimel', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, USA.'}, {'ForeName': 'Jean F', 'Initials': 'JF', 'LastName': 'Wyman', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, USA.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, USA.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glab092']
519,33245144,Oral self-management of palbociclib (Ibrance®) using mobile technology protocol.,"AIM


This study will test the feasibility and effectiveness of mobile technology intervention on the patients' self-management of oral anticancer medication. Secondary objectives include acceptability, the usefulness of text messages, and satisfaction by participants and nurses.
METHODS


This prospective two-arm study will recruit patients (N = 220) with metastatic breast cancer and initiating treatment with palbociclib (Ibrance ®). Allowing for attrition, patients will be randomized into the control (N = 100) or intervention (N = 100) group. Unidirectional text message reminders will be sent during the treatment cycle through a secure web application using the patient's smartphone. Self-reported survey responses will be collected at three time points; at consent, end of treatment cycles, and the follow-up clinic visit and include a demographic questionnaire, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Post study questionnaire and the R-15 Patient Satisfaction Questionnaire. Nurses providing care for study patients will complete the Adaptation of Stamps Nurse Workload questionnaire. Data will be analysed an intent-to-treat analysis comparing the two arms. Study approval was obtained in December 2019 and funded in January 2020.
DISCUSSION


Smartphones are globally available and have text messaging capability which is increasingly being used as an intervention in healthcare studies. This study will test a low-cost, nurse-led intervention that enhances the patient's experience with oral anti-cancer medications, improves access to care, reduces costs, and improves the satisfaction of nurses caring for oncology patients.
IMPACT


Despite the ease of administering oral anti-cancer medications, oncology patients maynot take them as prescribed and consequently, these factors affect patient outcomes and disease control. Given the importance of taking oral anti-cancer medications and the difficulties patients experience in achieving it, the effective use of mobile technology interventions can actively engage patients in their care and improve medication self-management of anticancer treatment regimens.",2021,Unidirectional text message reminders will be sent during the treatment cycle through a secure web application using the patient's smartphone.,"['nurses caring for oncology patients', 'patients (N\xa0=\xa0220) with metastatic breast cancer and initiating treatment with palbociclib (Ibrance ®', 'December 2019 and funded in January 2020', ""patients' self-management of oral anticancer medication""]","['oral anti-cancer medications', 'mobile technology intervention', 'Oral self-management of palbociclib (Ibrance®', 'mobile technology interventions']","['acceptability, the usefulness of text messages, and satisfaction by participants and nurses']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C3883373', 'cui_str': 'Ibrance'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C3883373', 'cui_str': 'Ibrance'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]",,0.0349031,Unidirectional text message reminders will be sent during the treatment cycle through a secure web application using the patient's smartphone.,"[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Mazzella Ebstein', 'Affiliation': 'Office of Nursing Research, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Barton-Burke', 'Affiliation': 'Office of Nursing Research, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Venice', 'Initials': 'V', 'LastName': 'Anthony', 'Affiliation': 'Breast and Imaging Center, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Breast and Imaging Center, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robson', 'Affiliation': 'Office of Nursing Research, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",Journal of advanced nursing,['10.1111/jan.14659']
520,33251910,Efficacy and safety of eltrombopag in Chinese patients with chronic immune thrombocytopenia: stage 2 results from a multicenter phase III study.,"This phase III, randomized, placebo-controlled study conducted in three stages (6-week, randomized, placebo-controlled stage 1; 24-week, open-label stage 2; and continuous extension stage 3) assessed the long-term efficacy and safety of eltrombopag use in Chinese patients with chronic immune thrombocytopenia (ITP). This article presents the results from stage 2. Overall, 150 patients (placebo-eltrombopag [P-E], 50; eltrombopag-eltrombopag [E-E], 100) received open-label eltrombopag. The median platelet count was maintained between 41 × 10 9 /L and 80 × 10 9 /L. Most patients in both groups (P-E, 90.0%; E-E, 81.8%) achieved platelet counts ≥30 × 10 9 /L and ≥2 times the baseline platelet count at least once with eltrombopag treatment. Overall, 32% of patients achieved platelet counts ≥50 × 10 9 /L in ≥75% of platelet count assessments. Both groups showed a decreased tendency to infrequent bleeding and clinically significant bleeding events during stage 2 compared with baseline. Among patients who received ≥1 ITP medication at baseline, 70.4% in the P-E group and 40.8% in the E-E group reduced or permanently stopped ≥1 of their ITP medications. The stage 2 results further demonstrated a sustainable long-term efficacy and good tolerability of eltrombopag with a favorable benefit-risk ratio in Chinese chronic ITP patients.Trial registration: Clinicaltrials.gov NCT01762761. Registered 8 January 2013, https://clinicaltrials.gov/ct2/show/NCT01762761.",2022,"Most patients in both groups (P-E, 90.0%; E-E, 81.8%) achieved platelet counts ≥30 ","['150 patients', 'Chinese chronic ITP patients', 'Chinese patients with chronic immune thrombocytopenia (ITP', 'Chinese patients with chronic immune thrombocytopenia', '10 9']","['placebo', 'placebo-eltrombopag', 'eltrombopag-eltrombopag [E-E], 100) received open-label eltrombopag', 'eltrombopag']","['infrequent bleeding and clinically significant bleeding events', 'platelet counts ≥30', 'Efficacy and safety', 'median platelet count', 'sustainable long-term efficacy and good tolerability', 'platelet counts ≥50', 'baseline platelet count']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1831905', 'cui_str': 'eltrombopag'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.179537,"Most patients in both groups (P-E, 90.0%; E-E, 81.8%) achieved platelet counts ≥30 ","[{'ForeName': 'Xiaofan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': ""Qilu Hospital, Shandong University, Ji'nan, China.""}, {'ForeName': 'Junmin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'The First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, China.'}, {'ForeName': 'Meijuan', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Fujian Union Hospital, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ziqiang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'The First Affiliated Hospital of Soochow University, Soochow University, Suzhou, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'The seventh Affiliated Hospital, Sun Yat-sen University, Shenzhen, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Peking University People's Hospital, Peking University, Beijing, China.""}, {'ForeName': 'Renchi', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}]",Platelets,['10.1080/09537104.2020.1847267']
521,33791930,A Rebuttal-Based Social Norms-Tailored Cannabis Intervention for At-Risk Adolescents.,"Many past cannabis prevention campaigns have proven largely ineffective due in part to the diversity of adolescents' cannabis-relevant beliefs. The current studies evaluated the impact of a sequential multiple message approach tailored to the usage norms of adolescents expressing negative attitudes toward a cannabis prevention appeal. A multiple-message strategy was implemented-initial unfavorable message evaluations were invalidated using attitudinal rebuttal feedback prior to presenting a third tailored communication. Participants were cannabis-abstinent middle and high school students (ages 11 to 16). Study 1 (N = 808) compared effects of gain- and loss-framed messages tailored to each student's normative usage perceptions. In Study 2 (N = 391), students were randomly assigned to receive a tailored or non-tailored message after receiving feedback meant to destabilize anti-message attitudes. For at-risk adolescents in Study 1 who perceived cannabis use as normative, a tailored gain-framed message resulted in the lowest usage intentions (p < .05). In Study 2, a conditional multiple-moderated mediation model showed that for high-risk teens with normative beliefs and pro-cannabis attitudes, exposure to a tailored gain-framed communication was associated with decreased cannabis attitude certainty, and lower usage intentions 2 months later (p < .05). Findings have implications for sequential messaging utilization in mass media campaigns and support the efficacy of tailored messages over a one-size-fits-all media approach. Further, results suggest that systematically weakening resistance to persuasive communications and tailoring messages consistent with individually perceived peer norms is an effective prevention strategy.",2021,"In Study 2 (N = 391), students were randomly assigned to receive a tailored or non-tailored message after receiving feedback meant to destabilize anti-message attitudes.","['At-Risk Adolescents', 'In Study 2 (N = 391), students', 'Participants were cannabis-abstinent middle and high school students (ages 11 to 16', 'adolescents expressing negative attitudes toward a cannabis prevention appeal']","['Rebuttal-Based Social Norms-Tailored Cannabis Intervention', ""gain- and loss-framed messages tailored to each student's normative usage perceptions"", 'tailored or non-tailored message after receiving feedback meant to destabilize anti-message attitudes']",['cannabis attitude certainty'],"[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1262620', 'cui_str': 'Negative attitude'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205423', 'cui_str': 'Certain'}]",,0.016923,"In Study 2 (N = 391), students were randomly assigned to receive a tailored or non-tailored message after receiving feedback meant to destabilize anti-message attitudes.","[{'ForeName': 'Candice D', 'Initials': 'CD', 'LastName': 'Donaldson', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10thSt., Claremont, CA, 91711, USA.'}, {'ForeName': 'Eusebio M', 'Initials': 'EM', 'LastName': 'Alvaro', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10thSt., Claremont, CA, 91711, USA.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Ruybal', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10thSt., Claremont, CA, 91711, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Coleman', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10thSt., Claremont, CA, 91711, USA.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Siegel', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10thSt., Claremont, CA, 91711, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Crano', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10thSt., Claremont, CA, 91711, USA. William.crano@cgu.edu.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-021-01224-9']
522,33252489,Depressive symptoms and use of HIV care and medication-assisted treatment among people with HIV who inject drugs.,"OBJECTIVE


Vietnam, Indonesia, and Ukraine have major burdens of IDU and HIV. We estimated the prevalence of depressive symptoms at baseline among people living with HIV who inject drugs, evaluated associations between depression at baseline and 12-month HIV care outcomes and medication-assisted treatment (MAT), and evaluated the study intervention effect by baseline depression subgroups.
DESIGN


HPTN 074 was a randomized study. The study intervention included psychosocial counseling, systems navigation, and antiretroviral treatment (ART) at any CD4+ cell count.
METHODS


Moderate-to-severe depression was defined as a Patient Health Questionnaire-9 score of 10 or above. ART and MAT were self-reported. Eligibility criteria were: 18-60 years of age, active IDU, and viral load of at least 1000 copies/ml. Adjusted probability differences (aPD) were estimated using inverse-probability weighting.
RESULTS


A total of 502 participants enrolled from April 2015 to June 2016. Median age was 35 years; 85% identified as men. Prevalence of baseline moderate-to-severe depression was 14% in Vietnam, 14% in Indonesia, and 56% in Ukraine. No evident associations were detected between baseline depression and ART, viral suppression, or MAT at 12-month follow-up. The study intervention improved the proportions of people who inject drugs achieving 12-month viral suppression in both the depressed [intervention 44%; standard of care 24%; estimated aPD = 25% (95% confidence interval: 4.0%, 45%)] and nondepressed subgroups [intervention 38%; standard of care 24%; aPD = 13% (95% confidence interval: 2.0%, 25%)].
CONCLUSION


High levels of depressive symptoms were common among people living with HIV who inject drugs in Ukraine but were less common in Vietnam and Indonesia. The study intervention was effective among participants with or without baseline depression symptoms.",2021,"No evident associations were detected between baseline depression and ART, viral suppression, or MAT at 12-month follow-up.","['people living with HIV (PLWH) who inject drugs, evaluated associations between depression at baseline and 12-month HIV care outcomes and medication-assisted treatment (MAT), and evaluated the study intervention effect by baseline depression subgroups', 'participants with or without baseline depression symptoms', 'Median age was 35 years; 85% identified as men', 'Moderate-to-severe depression was defined as a Patient Health Questionnaire (PHQ-9) score of 10 or above', '502 participants enrolled from April 2015-June 2016', 'people living with HIV who inject drugs']","['psychosocial counseling, systems navigation, and antiretroviral treatment (ART) at any CD4 count', 'HIV care and medication-assisted treatment']","['Depressive symptoms', 'proportions of PWID achieving 12-month viral suppression', 'baseline depression and ART, viral suppression, or MAT', 'depressive symptoms', 'Prevalence of baseline moderate-to-severe depression']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0841579', 'cui_str': 'Psychosocial counseling'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]",502.0,0.166131,"No evident associations were detected between baseline depression and ART, viral suppression, or MAT at 12-month follow-up.","[{'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Zeziulin', 'Affiliation': 'Ukrainian Institute on Public Health Policy, Kyiv, Ukraine.'}, {'ForeName': 'Katie R', 'Initials': 'KR', 'LastName': 'Mollan', 'Affiliation': 'School of Medicine.'}, {'ForeName': 'Bonnie E', 'Initials': 'BE', 'LastName': 'Shook-Sa', 'Affiliation': 'Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Hanscom', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention (SCHARP), Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lancaster', 'Affiliation': 'College of Public Health, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Kostyantyn', 'Initials': 'K', 'LastName': 'Dumchev', 'Affiliation': 'Ukrainian Institute on Public Health Policy, Kyiv, Ukraine.'}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Viet A', 'Initials': 'VA', 'LastName': 'Chu', 'Affiliation': 'UNC Vietnam, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tetiana', 'Initials': 'T', 'LastName': 'Kiriazova', 'Affiliation': 'Ukrainian Institute on Public Health Policy, Kyiv, Ukraine.'}, {'ForeName': 'Zulvia', 'Initials': 'Z', 'LastName': 'Syarif', 'Affiliation': 'Abhipraya Foundation & Department Psychiatry Faculty of Medicine, University of Indonesia, Depok, Indonesia.'}, {'ForeName': 'Sergii', 'Initials': 'S', 'LastName': 'Dvoryak', 'Affiliation': 'Ukrainian Institute on Public Health Policy, Kyiv, Ukraine.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Reifeis', 'Affiliation': 'Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Hamilton', 'Affiliation': 'Family Health International (FHI 360), Durham, North Carolina, USA.'}, {'ForeName': 'Riza', 'Initials': 'R', 'LastName': 'Sarasvita', 'Affiliation': 'Indonesia National Narcotics Board & Abhipraya Foundation, East Jakarta, Indonesia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': 'Family Health International (FHI 360), Durham, North Carolina, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Clarke', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Metzger', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Irving F', 'Initials': 'IF', 'LastName': 'Hoffman', 'Affiliation': 'School of Medicine.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Miller', 'Affiliation': 'College of Public Health, The Ohio State University, Columbus, Ohio, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002774']
523,33252482,Optimizing respondent-driven sampling to find undiagnosed HIV-infected people who inject drugs.,"OBJECTIVE


We evaluated whether identification of undiagnosed HIV-infected people who inject drugs (PWID) via respondent-driven sampling (RDS) can be enhanced through a precision RDS (pRDS) approach.
DESIGN/METHODS


First, using prior RDS data from PWID in India, we built a prediction algorithm for recruiting undiagnosed HIV-infected PWID. pRDS was tested in Morinda, Punjab where participants were randomly assigned to standard or pRDS. In the standard RDS approach, all participants received two recruitment coupons. For pRDS, the algorithm determined an individual's probability of recruiting an undiagnosed PWID, and individuals received either two (low probability) or five (high probability) coupons. Efficiency in identifying undiagnosed HIV-infected PWID for the RDS approaches was evaluated in two ways: the number needed to recruit (NNR) and identification rate/week.
RESULTS


Predictors of recruiting undiagnosed PWID included HIV/HCV infection, network size, syringe services utilization, and injection environment. 1631 PWID were recruited in Morinda. From the standard RDS approach, 615 were recruited, including 39 undiagnosed; from pRDS, 1012 were recruited, including 77 undiagnosed. In pRDS, those with higher predicted probability were more likely to recruit others with HIV/HCV co-infection, undiagnosed and viremic HIV, and who utilized services. pRDS had a significantly higher identification rate of undiagnosed PWID (1.5/week) compared with the standard (0.8/week). The NNR for pRDS (13.1) was not significantly lower than the standard approach (15.8).
CONCLUSION


pRDS identified twice as many undiagnosed and viremic PWID significantly faster than the standard approach. Leveraging RDS or similar network-based strategies should be considered alongside other strategies to ensure meeting UNAIDS targets.",2021,"The NNR for pRDS (13.1) was not significantly lower than the standard approach (15.8).
","['undiagnosed HIV-infected people who inject drugs', '1631 PWID were recruited in Morinda', '615 were recruited, including 39 undiagnosed; from pRDS, 1012 were recruited, including 77 undiagnosed', 'undiagnosed HIV-infected people who inject drugs (PWID) via respondent-driven sampling (RDS']","['standard or pRDS', 'pRDS']","['identification rate of undiagnosed PWID', 'HIV/HCV infection, network size, syringe services utilization, and injection environment']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1010821', 'cui_str': 'Morinda'}, {'cui': 'C5192273', 'cui_str': '615'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",1631.0,0.0633873,"The NNR for pRDS (13.1) was not significantly lower than the standard approach (15.8).
","[{'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'McFall', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Mayland, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Lau', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Mayland, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Latkin', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Mayland, USA.'}, {'ForeName': 'Aylur K', 'Initials': 'AK', 'LastName': 'Srikrishnan', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education, Chennai, India.'}, {'ForeName': 'Santhanam', 'Initials': 'S', 'LastName': 'Anand', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education, Chennai, India.'}, {'ForeName': 'Canjeevaram K', 'Initials': 'CK', 'LastName': 'Vasudevan', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education, Chennai, India.'}, {'ForeName': 'Shruti H', 'Initials': 'SH', 'LastName': 'Mehta', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Mayland, USA.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Solomon', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002763']
524,33248115,Percent Body Fat Content Measured by Plethysmography in Infants Randomized to High- or Usual-Volume Feeding after Very Preterm Birth.,We measured percent body fat by air-displacement plethysmography in 86 infants born at <32 weeks of gestation randomized to receive either high-volume (180-200 mL/kg/day) or usual volume feeding (140-160 mL/kg/day). High-volume feeding increased percent body fat by ≤2% at 36 weeks of postmenstrual age (within a predefined range of equivalence). TRIAL REGISTRATION: ClincialTrials.gov: NCT02377050.,2021,,[],[],['Percent Body Fat Content'],[],[],"[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",,0.0258087,,"[{'ForeName': 'Ariel A', 'Initials': 'AA', 'LastName': 'Salas', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Alabama at Birmingham, Birmingham, AL. Electronic address: asalas@peds.uab.edu.'}, {'ForeName': 'Colm P', 'Initials': 'CP', 'LastName': 'Travers', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Jerome', 'Affiliation': 'Department of Nutrition Sciences, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Chandler-Laney', 'Affiliation': 'Department of Nutrition Sciences, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Alabama at Birmingham, Birmingham, AL.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.11.028']
525,33248743,"Assessing barriers to providing tobacco use disorder treatment in community mental health settings with a revised version of the Smoking Knowledge, Attitudes, and Practices (S-KAP) instrument.","BACKGROUND


Tobacco use disorder (TUD) rates are 2-3 times higher among people with serious mental illness (SMI) than the general population. Clinicians working in outpatient community mental health clinics are well positioned to provide TUD treatment to this group, but rates of treatment provision are very low. Understanding factors associated with the provision of TUD treatment by mental health clinicians is a priority.
METHODS


This study used baseline data from an ongoing cluster-randomized clinical trial evaluating two approaches to training clinicians to increase TUD treatment. Following a psychometric assessment of our assessment tool, the Smoking Knowledge, Attitudes, and Practices (S-KAP) instrument, a new factor structure was evaluated utilizing confirmatory factor analysis. Structural equation modeling was then used to examine the associations between TUD treatment practices and clinician, setting, and patient characteristics in a sample of 182 mental health clinicians across 10 mental health clinics.
RESULTS


Clinician but not setting or patient characteristics emerged as significant correlates of providing TUD treatment. Specifically, clinicians' general ethical commitment to providing TUD services and perceptions of their skills in providing this type of care were associated with providing TUD treatment. In contrast, clinician perceptions of patient motivation, anticipated quit rates, or available setting resources were not significantly associated with providing TUD treatment.
CONCLUSIONS


Enhancing community mental health clinician TUD treatment skills and commitment to providing such services may reduce TUD rates among people with SMI. Future studies should evaluate interventions that target these factors.",2021,"CONCLUSIONS


Enhancing community mental health clinician TUD treatment skills and commitment to providing such services may reduce TUD rates among people with SMI.","['outpatient community mental health clinics', '182 mental health clinicians across 10 mental health clinics', 'people with serious mental illness (SMI) than the general population', 'people with SMI']",[],"['TUD rates', 'quit rates, or available setting resources']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0040336', 'cui_str': 'Tobacco abuse'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",182.0,0.0630986,"CONCLUSIONS


Enhancing community mental health clinician TUD treatment skills and commitment to providing such services may reduce TUD rates among people with SMI.","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Siegel', 'Affiliation': 'Value Institute and Helen F. Graham Cancer Center & Research Institute, Christiana Care Health System, United States. Electronic address: ssiegel@christianacare.org.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Laurenceau', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, United States.'}, {'ForeName': 'Naja', 'Initials': 'N', 'LastName': 'Hill', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Anna-Marika', 'Initials': 'AM', 'LastName': 'Bauer', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Flitter', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Ziedonis', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, United States.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Stevens', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Hosie Quinn', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Leone', 'Affiliation': 'Pulmonary, Allergy, & Critical Care Division, University of Pennsylvania, United States.'}, {'ForeName': 'Rinad', 'Initials': 'R', 'LastName': 'Beidas', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States; Department of Medical Ethics and Health Policy, Penn Implementation Science Center at the Leonard Davis Institute (PISCE@LDI), United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kimberly', 'Affiliation': 'The Wharton School of Business, University of Pennsylvania, United States.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106735']
526,33249632,Group-randomized trial of tailored brief shared decision-making to improve asthma control in urban black adults.,"AIMS


To assess the intervention effects of BREATHE (BRief intervention to Evaluate Asthma THErapy), a novel brief shared decision-making intervention and evaluate feasibility and acceptability of intervention procedures.
DESIGN


Group-randomized longitudinal pilot study.
METHODS


In total, 80 adults with uncontrolled persistent asthma participated in a trial comparing BREATHE (N = 40) to a dose-matched attention control intervention (N = 40). BREATHE is a one-time shared decision-making intervention delivered by clinicians during routine office visits. Ten clinicians were randomized and trained on BREATHE or the control condition. Participants were followed monthly for 3 months post-intervention. Data were collected from December 2017 - May 2019 and included surveys, lung function tests, and interviews.
RESULTS


Participants were Black/multiracial (100%) mostly female (83%) adults (mean age 45). BREATHE clinicians delivered BREATHE to all 40 participants with fidelity based on expert review of audiorecordings. While the control group reported improvements in asthma control at 1-month and 3-month follow-up, only BREATHE participants had better asthma control at each timepoint (β = 0.77; standard error (SE)[0.17]; p ≤ 0.0001; β = 0.71; SE[0.16]; p ≤ 0.0001; β = 0.54; SE[0.15]; p = .0004), exceeding the minimally important difference. BREATHE participants also perceived greater shared decision-making occurred during the intervention visit (β = 7.39; SE[3.51]; p = .03) and fewer symptoms at follow-up (e.g., fewer nights woken, less shortness of breath and less severity of symptoms) than the controls. Both groups reported improved adherence and fewer erroneous medication beliefs.
CONCLUSION


BREATHE is a promising brief tailored intervention that can be integrated into office visits using clinicians as interventionists. Thus, BREATHE offers a pragmatic approach to improving asthma outcomes and shared decision-making in a health disparity population.
IMPACT


The study addressed the important problem of uncontrolled asthma in a high-risk vulnerable population. Compared with the dose-matched attention control condition, participants receiving the novel brief tailored shared decision-making intervention had significant improvements in asthma outcomes and greater perceived engagement in shared decision-making. Brief interventions integrated into office visits and delivered by clinicians may offer a pragmatic approach to narrowing health disparity gaps. Future studies where other team members (e.g., office nurses, social workers) are trained in shared decision-making may address important implementation science challenges as it relates to adoption, maintenance, and dissemination. TRAIL REGISTRATION: clinicaltrials.gov # NCT03300752.",2021,"BREATHE participants also perceived greater shared decision-making occurred during the intervention visit (β = 7.39; SE[3.51]; p = .03) and fewer symptoms at follow-up (e.g., fewer nights woken, less shortness of breath and less severity of symptoms) than the controls.","['Participants were Black/multiracial (100%) mostly female (83%) adults (mean age 45', 'Data were collected from December 2017 - May 2019 and included surveys, lung function tests, and interviews', 'uncontrolled asthma in a high-risk vulnerable population', 'urban black adults', '80 adults with uncontrolled persistent asthma', '40 participants with fidelity based on expert review of audiorecordings']","['tailored brief shared decision-making', 'dose-matched attention control intervention']","['shortness of breath and less severity of symptoms', 'asthma outcomes and greater perceived engagement in shared decision-making', 'asthma control', 'adherence and fewer erroneous medication beliefs']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0699752', 'cui_str': 'Review of'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C3541364', 'cui_str': 'Erroneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",80.0,0.0381982,"BREATHE participants also perceived greater shared decision-making occurred during the intervention visit (β = 7.39; SE[3.51]; p = .03) and fewer symptoms at follow-up (e.g., fewer nights woken, less shortness of breath and less severity of symptoms) than the controls.","[{'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'George', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Bruzzese', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Lynn S Sommers', 'Affiliation': 'University of Pennsylvania School of Nursing, Philadelphia, PA, USA.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Pantalon', 'Affiliation': 'Department of Emergency Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Haomiao', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Columbia University School of Nursing, Columbia University Mailman School of Public Health, New York, NY, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rhodes', 'Affiliation': 'University of Pennsylvania School of Nursing, Philadelphia, PA, USA.'}, {'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Norful', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Chung', 'Affiliation': 'Center for Health Behavior Research, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Chittams', 'Affiliation': 'Biostatistics Analysis Core, University of Pennsylvania School of Nursing, Philadelphia, PA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Coleman', 'Affiliation': 'Xxxx, Philadelphia, PA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Glanz', 'Affiliation': 'Perelman School of Medicine and School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of advanced nursing,['10.1111/jan.14646']
527,34118248,Effect of vitamin D supplementation on total and allergen-specific IgE in children with asthma and low vitamin D levels.,"BACKGROUND


Observational studies have yielded inconsistent findings for the relation between vitamin D level and total IgE or allergic sensitization.
OBJECTIVE


To determine whether vitamin D supplementation reduces levels of total IgE and IgE to each of 2 common indoor allergens in children with asthma and low vitamin D levels.
METHODS


Total IgE, IgE to Dermatophagoides pteronyssinus, and IgE to Blattella germanica were measured at the randomization and exit visits for 174 participants in the Vitamin D Kids Asthma Study, a multicenter, double-blind, randomized placebo-controlled trial of vitamin D 3  supplementation (4000 IU/d) to prevent severe exacerbations in children with persistent asthma and vitamin D levels less than 30 ng/mL. Multivariable linear regression was used for the analysis of the effect of vitamin D supplementation on change in each IgE measure.
RESULTS


Participants were followed for an average of 316 days. At the exit visit, more subjects in the vitamin D arm achieved a vitamin D level equal to or more than 30 ng/mL compared with those in the placebo arm (87% vs 30%; P < .001). In a multivariable analysis, vitamin D 3  supplementation had no significant effect on change in total IgE, IgE to Dermatophagoides pteronyssinus, or IgE to Blattella germanica between the exit and randomization visits (eg, for log 10  total IgE, β = 0.007; 95% CI, -0.061 to 0.074; P = .85).
CONCLUSIONS


Vitamin D supplementation, compared with placebo, has no significant effect on serum levels of total IgE, IgE to dust mite, or IgE to cockroach in children with asthma and low vitamin D levels.",2022,"CONCLUSION


Vitamin D supplementation, compared to placebo, has no significant effect on serum levels of total IgE, IgE to dust mite, or IgE to cockroach in children with asthma and low vitamin D levels.","['children with asthma and low vitamin D levels', 'Total IgE, IgE to Dermatophagoides pteronyssinus (Der p), and IgE to Blattella germanica (Bla g) were measured at the randomization and exit visits for 174 participants in the Vitamin D Kids Asthma study (VDKA', 'children with persistent asthma and vitamin D levels <30 ng/ml']","['vitamin D supplementation', 'placebo', 'vitamin D 3  supplementation', 'Vitamin D supplementation']","['lung function', 'total IgE, IgE to Der p, or IgE to Bla g between the exit and randomization visits', 'serum levels of total IgE, IgE to dust mite, or IgE to cockroach', 'total IgE and IgE']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4285871', 'cui_str': 'Vitamin D low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0323674', 'cui_str': 'Dermatophagoides'}, {'cui': 'C0322502', 'cui_str': 'Blattella germanica'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0323674', 'cui_str': 'Dermatophagoides'}, {'cui': 'C0322502', 'cui_str': 'Blattella germanica'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0009208', 'cui_str': 'Cockroach'}]",,0.453991,"CONCLUSION


Vitamin D supplementation, compared to placebo, has no significant effect on serum levels of total IgE, IgE to dust mite, or IgE to cockroach in children with asthma and low vitamin D levels.","[{'ForeName': 'Franziska J', 'Initials': 'FJ', 'LastName': 'Rosser', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, Pa.""}, {'ForeName': 'Yueh-Ying', 'Initials': 'YY', 'LastName': 'Han', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, Pa.""}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Forno', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, Pa.""}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': ""Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, Monroe Carell Jr Children's Hospital at Vanderbilt, Nashville, Tenn.""}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Division of Allergy and Immunology, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Theresa W', 'Initials': 'TW', 'LastName': 'Guilbert', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Cabana', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Ross', 'Affiliation': ""Division of Pediatric Pulmonology, UH Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, Ohio.""}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Blatter', 'Affiliation': ""Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, Saint Louis Children's Hospital, Washington University at Saint Louis, St Louis, Mo.""}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Durrani', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Luther', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Celedón', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, Pa. Electronic address: juan.celedon@chp.edu.""}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2021.05.037']
528,34118150,Perioperative platelet reduction after sutureless or stented valve implantation: results from the PERSIST-AVR controlled randomized trial.,"OBJECTIVES


Platelet count reduction is a common but not fully understood phenomenon after aortic valve replacement (AVR) with bioprosthesis implantation. The aim of the present study was to investigate the occurrence and the clinical impact of platelet count reduction in patients receiving the Perceval bioprosthesis compared to those receiving standard sutured stented bioprosthetic aortic valve in a randomized, controlled AVR study.
METHODS


PERceval Sutureless Implant versus STandard Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016-September 2018) to AVR with a sutureless or stented valve. Ad hoc analyses have been performed to evaluate the occurrence of platelet count reduction and the clinical impact of the platelet variations in the 2 groups.
RESULTS


The Perceval group showed a higher platelet reduction than the control group (46% vs 32%). The phenomenon was transient in both groups, with a slow recovery of the platelet count by hospital discharge. No differences were observed between groups regarding need of transfusions, blood loss, major bleeding and stroke events.
CONCLUSIONS


The Perceval sutureless aortic bioprosthesis implantation is associated with higher rate of transient platelet reduction as compared to stented bioprostheses for AVR. However, the platelet count reduction is transient and the decline does not affect the patient's clinical outcomes. Current explanations for this phenomenon are speculative, and further investigations are required to elucidate it.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02673697-ClinicalTrials.gov-4 February 2016.",2021,"No differences were observed between groups regarding need of transfusions, blood loss, major bleeding and stroke events.
",['patients receiving the'],"['PERceval Sutureless Implant versus STandard Aortic Valve Replacement', 'sutureless or stented valve implantation', 'AVR with a sutureless or stented valve', 'standard sutured stented bioprosthetic aortic valve', 'Perceval bioprosthesis']","['Perioperative platelet reduction', 'platelet reduction', 'need of transfusions, blood loss, major bleeding and stroke events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0005557', 'cui_str': 'Bioprosthesis'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.10454,"No differences were observed between groups regarding need of transfusions, blood loss, major bleeding and stroke events.
","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Lorusso', 'Affiliation': 'Cardio-Thoracic Surgery Department, Heart and Vascular Center, Maastricht University Medical Center (MUMC+), Maastricht, Netherlands.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Jiritano', 'Affiliation': 'Cardio-Thoracic Surgery Department, Heart and Vascular Center, Maastricht University Medical Center (MUMC+), Maastricht, Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Roselli', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Malakh', 'Initials': 'M', 'LastName': 'Shrestha', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Folliguet', 'Affiliation': 'Department of Cardiac Surgery, Hôpital Henri Mondor, Université Paris 12, Créteil, Paris, France.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Meuris', 'Affiliation': 'Cardiac Surgery Department, Universitaire Ziekenhuizen Leuven, Leuven, Belgium.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pollari', 'Affiliation': 'Klinikum Nürnberg, Cardiovascular Center, Paracelsus Medical University, Nuremberg, Germany.'}, {'ForeName': 'Theodor', 'Initials': 'T', 'LastName': 'Fischlein', 'Affiliation': 'Klinikum Nürnberg, Cardiovascular Center, Paracelsus Medical University, Nuremberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezab175']
529,34118298,"Delgocitinib ointment in pediatric patients with atopic dermatitis: A phase 3, randomized, double-blind, vehicle-controlled study and a subsequent open-label, long-term study.","BACKGROUND


Delgocitinib 0.5% ointment, a topical Janus kinase inhibitor, has been approved in Japan for adult patients with atopic dermatitis (AD).
OBJECTIVE


To evaluate the efficacy and safety of delgocitinib ointment in pediatric patients with AD.
METHODS


Part 1 of this study was a 4-week double-blind period in which Japanese patients aged 2 through 15 years were randomized in a 1:1 ratio to delgocitinib 0.25% ointment or vehicle ointment. Part 2 was a 52-week extension period. Eligible patients entered part 2 to receive 0.25% or 0.5% delgocitinib ointment.
RESULTS


At the initiation of the study, approximately half of the patients had moderate AD. At the end of treatment in part 1, the least-squares mean percent change from baseline in modified Eczema Area and Severity Index score, the primary efficacy endpoint, was significantly greater for delgocitinib ointment than for vehicle (-39.3% vs +10.9%, P < .001). In part 2, improvements in AD were also seen through week 56. Most adverse events were mild and unrelated to delgocitinib across the study periods.
LIMITATIONS


Only Japanese patients were included. In part 2, no control group was included and rescue therapy was allowed.
CONCLUSION


Delgocitinib ointment was effective and well tolerated when applied to Japanese pediatric patients with AD for up to 56 weeks.",2021,Delgocitinib ointment was effective and well tolerated when applied to Japanese pediatric patients with AD for up to 56 weeks.,"['Japanese pediatric patients with AD for up to 56 weeks', 'Only Japanese patients', 'pediatric patients with AD', 'Japanese patients aged 2 through 15 years', 'adult patients with atopic dermatitis (AD) in Japan', 'pediatric patients with atopic dermatitis', 'Eligible patients entered part 2, a 52-week extension period, to receive 0.25% or 0.5']","['Delgocitinib ointment', 'delgocitinib ointment', 'delgocitinib 0.25% ointment or vehicle ointment', 'topical JAK inhibitor']","['modified Eczema Area and Severity Index score', 'efficacy and safety', 'effective and well tolerated']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.511637,Delgocitinib ointment was effective and well tolerated when applied to Japanese pediatric patients with AD for up to 56 weeks.,"[{'ForeName': 'Hidemi', 'Initials': 'H', 'LastName': 'Nakagawa', 'Affiliation': 'Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Nemoto', 'Affiliation': 'Kojinkai Sapporo Skin Clinic, Hokkaido, Japan.'}, {'ForeName': 'Atsuyuki', 'Initials': 'A', 'LastName': 'Igarashi', 'Affiliation': 'Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hidehisa', 'Initials': 'H', 'LastName': 'Saeki', 'Affiliation': 'Department of Dermatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kabashima', 'Affiliation': 'Department of Dermatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Oda', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco Inc, Tokyo, Japan. Electronic address: manabu.oda@jt.com.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagata', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco Inc, Tokyo, Japan.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2021.06.014']
530,34121224,"Real-time continuous glucose monitoring in preterm infants (react): An International, open-label, randomised, controlled trial.",,2021,,['preterm infants (react'],[],[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C4224854', 'cui_str': 'React'}]",[],[],,0.0941968,,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Dinu', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rozance', 'Affiliation': 'University of Colorado, Aurora, CO, USA.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15946']
531,34138662,Foveal Displacement following Temporal Inverted Internal Limiting Membrane Technique for Full Thickness Macular Holes: 12 Months Results.,"Purpose:  To compare conventional 360° internal limiting membrane (ILM) peeling and temporal inverted ILM flap technique with regard to postoperative foveal displacement. Methods:  Patients who underwent 23 G vitrectomy with either 360° ILM peeling (Group 1) or temporal inverted ILM technique (Group 2) for idiopathic macular hole with a minimum follow up of 12 months were included. The metamorphopsia rates and distances between fovea and 3 retinal landmarks: the first retinal vascular bifurcation or crossover located superonasal and inferonasal to the fovea and ciliary vessel at the temporal margin of the disc, were compared on MultiColor SLO and near-infrared reflectance images. In addition, papillofoveal distance was measured on B-scan optical coherence tomography (OCT). Results:  A total of 57 eyes were recruited (Group 1, n = 25; Group 2, n = 32). The visual acuity at month-1 was significantly higher in Group 2 than Group 1 ( p  = .007). A significant postoperative foveal displacement towards the disc was observed in Group 1 and Group 2 ( p  < .001 and  p  = .002 respectively). Shortening of the papillofoveal distance was greater in Group 1 than Group 2 at all postoperative visits ( p  < .05 for all). Furthermore, significant changes in papillofoveal distance continued until 6 months in Group 1 ( p  < .05 for all), whereas no significant changes occurred in Group 2 after month-1 ( p  > .05 for all). The complaints of metamorphopsia was significantly higher in Group 1 (n = 18/25) compared with Group 2 (n = 10/32) ( p  = .002). Conclusion:  Temporal inverted ILM flap appear to be superior to 360° ILM peeling with regard to faster visual rehabilitation, lower rates of subjective metamorphopsia and less foveal displacement.",2021,The visual acuity at month-1 was significantly higher in Group 2 than Group 1 (p = .007).,"['A total of 57 eyes were recruited (Group 1, n = 25; Group 2, n = 32', 'Group 2) for idiopathic macular hole with a minimum follow up of 12 months were included', 'Patients who underwent 23']","['conventional 360° internal limiting membrane (ILM) peeling and temporal inverted ILM flap technique', 'Temporal Inverted Internal Limiting Membrane Technique', 'G vitrectomy with either 360° ILM peeling (Group 1) or temporal inverted ILM technique']","['papillofoveal distance', 'Shortening of the papillofoveal distance', 'complaints of metamorphopsia', 'rates of subjective metamorphopsia and less foveal displacement', 'postoperative foveal displacement', 'Foveal Displacement', 'visual acuity']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C4522321', 'cui_str': 'Inverted'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0271185', 'cui_str': 'Metamorphopsia'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",57.0,0.0387512,The visual acuity at month-1 was significantly higher in Group 2 than Group 1 (p = .007).,"[{'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Yilmaz', 'Affiliation': 'Retina Department, Bursa Retina Eye Hospital, Bursa, Turkey.'}, {'ForeName': 'Aysegul', 'Initials': 'A', 'LastName': 'Mavi Yildiz', 'Affiliation': 'Retina Department, Bursa Retina Eye Hospital, Bursa, Turkey.'}, {'ForeName': 'Remzi', 'Initials': 'R', 'LastName': 'Avci', 'Affiliation': 'Retina Department, Bursa Retina Eye Hospital, Bursa, Turkey.'}]",Current eye research,['10.1080/02713683.2021.1945110']
532,34119373,"Validation of the modified NUTrition Risk Score (mNUTRIC) in mechanically ventilated, severe burn patients: A prospective multinational cohort study.","BACKGROUND


Whether nutrition therapy benefits all burn victims equally is unknown. To identify patients who will benefit the most from optimal nutrition, the modified Nutrition Risk in Critically Ill (mNUTRIC) Score has been validated in the Intensive Care Unit. However, the utility of mNUTRIC in severe burn victims is unknown. We hypothesized that a higher mNUTRIC (≥5) will be associated with worse clinical outcomes, but that greater nutritional adequacy will be associated with better clinical outcomes in patients with higher mNUTRIC score.
METHODS


This prospective study included data from mechanically ventilated, severe burn patients (n = 359) from 51 Burn Units worldwide included in a randomized trial. Our primary and secondary outcomes were hospital mortality and the time to discharge alive (TTDA) from hospital. We described the association between nutrition performance and clinical outcomes.
RESULTS


Compared to low mNUTRIC (n = 313), the high mNUTRIC group (n = 46) had higher mortality (61% vs. 19%, p = 0.001), and longer TTDA (>90 [87->90] vs. 64 [38-90] days, p = <0.0001). Only in the high mNUTRIC group, increased calorie intake (per 20% increase) was associated with lower mortality and a faster TTDA.
CONCLUSIONS


The mNUTRIC score identifies those with poor clinical outcomes and may identifies those mechanically ventilated, severe burn patients in whom optimal nutrition therapy may be more advantageous.",2021,"Only in the high mNUTRIC group, increased calorie intake (per 20% increase) was associated with lower mortality and a faster TTDA.
","['mechanically ventilated, severe burn patients (n = 359) from 51 Burn Units worldwide included in a randomized trial', 'patients who will benefit the most from optimal nutrition, the modified Nutrition Risk in Critically Ill (mNUTRIC', 'mechanically ventilated, severe burn patients']",[],"['higher mortality', 'increased calorie intake', 'hospital mortality and the time to discharge alive (TTDA) from hospital']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006425', 'cui_str': 'Burns unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",359.0,0.0585844,"Only in the high mNUTRIC group, increased calorie intake (per 20% increase) was associated with lower mortality and a faster TTDA.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Alfonso Ortiz', 'Affiliation': ""Clinical Evaluation Research Unit, Queen's University, Kingston, ON, K7L 2V7, Canada; Department of Critical Care Medicine, Queen's University, Kingston, ON, K7L 2V7, Canada. Electronic address: laor@queensu.ca.""}, {'ForeName': 'Xuran', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Clinical Evaluation Research Unit, Queen's University, Kingston, ON, K7L 2V7, Canada. Electronic address: Xuran.Jiang@kingstonhsc.ca.""}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Université Laval, Québec City, QC, G1V 0A6, Canada; CHU de Québec - Université Laval Research Center, Population Health and Optimal Health Practices Research Unit, Trauma-Emergency-Critical Care Medicine, Québec City, QC, G1V 0A6, Canada. Electronic address: Alexis.Turgeon@fmed.ulaval.ca.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Wibbenmeyer', 'Affiliation': 'University of Iowa Hospital and Clinics, Iowa City, IA, 52242, USA. Electronic address: lucy-wibbenmeyer@uiowa.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Pollack', 'Affiliation': ""Mercy Research Institute, St. John's Mercy Hospital, St. Louis, MO, 63141, USA. Electronic address: jonathan.pollack@mercy.net.""}, {'ForeName': 'Samuel P', 'Initials': 'SP', 'LastName': 'Mandell', 'Affiliation': 'UW Medicine Regional Burn Center, Harborview Medical Center, Seattle, WA, 98104, USA. Electronic address: mandells@uw.edu.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Day', 'Affiliation': ""Clinical Evaluation Research Unit, Queen's University, Kingston, ON, K7L 2V7, Canada; Research Institute, Kingston Health Sciences Centre, Kingston, ON, K7L 2V7, Canada. Electronic address: Andrew.Day@kingstonhsc.ca.""}, {'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ""Clinical Evaluation Research Unit, Queen's University, Kingston, ON, K7L 2V7, Canada; Department of Critical Care Medicine, Queen's University, Kingston, ON, K7L 2V7, Canada; Research Institute, Kingston Health Sciences Centre, Kingston, ON, K7L 2V7, Canada. Electronic address: dkh2@queensu.ca.""}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2021.05.010']
533,34139706,Extracorporeal Albumin Dialysis in Liver Failure with MARS and SPAD: A Randomized Crossover Trial.,"INTRODUCTION


Liver failure is associated with hepatic and extrahepatic organ failure leading to a high short-term mortality rate. Extracorporeal albumin dialysis (ECAD) aims to reduce albumin-bound toxins accumulated during liver failure. ECAD detoxifies blood using albumin dialysis through an artificial semipermeable membrane with recirculation (molecular adsorbent recirculating system, MARS) or without (single-pass albumin dialysis, SPAD).
METHODS


We performed a randomized crossover open trial in a surgical intensive care unit. The primary outcome of the study was total bilirubin reduction during MARS and during SPAD therapies. The secondary outcomes were conjugated bilirubin and bile acid level reduction during MARS and SPAD sessions and tolerance of dialysis system devices. Inclusion criteria were adult patients presenting liver failure with factor V activity <50% associated with bilirubin ≥250 μmol/L and a complication (either hepatic encephalopathy, severe pruritus, or hepatorenal syndrome). For MARS and SPAD, the dialysis flow rate was equal to 1,000 mL/h.
RESULTS


Twenty crossovers have been performed. Baseline biochemical characteristics (bilirubin, ammonia, bile acids, creatinine, and urea) were not statistically different between MARS and SPAD. Both ECAD have led to a significant reduction in total bilirubin (-83 ± 67 μmol/L after MARS; -122 ± 118 μmol/L after SPAD session), conjugated bilirubin (-82 ± 61 μmol/L after MARS; -105 ± 96 μmol/L after SPAD session), and bile acid levels (-64 ± 75 μmol/L after MARS; -56 ± 56 μmol/L after SPAD session), all nondifferent comparing MARS to SPAD.
CONCLUSION


A simple-to-perform SPAD therapy with equal to MARS dialysate flow parameters provides the same efficacy in bilirubin and bile acid removal. However, clinically relevant endpoints have to be evaluated in randomized trials to compare MARS and SPAD therapies and to define the place of SPAD in the liver failure care program.",2022,"Baseline biochemical characteristics (bilirubin, ammonia, bile acids, creatinine, and urea) were not statistically different between MARS and SPAD.","['Liver Failure with MARS and SPAD', 'Inclusion criteria were adult patients presenting liver failure with factor V activity <50% associated with bilirubin ≥250 μmol/L and a complication (either hepatic encephalopathy, severe pruritus, or hepatorenal syndrome']","['ECAD', 'Extracorporeal albumin dialysis (ECAD', 'Extracorporeal Albumin Dialysis']","['total bilirubin reduction', 'total bilirubin', 'Baseline biochemical characteristics (bilirubin, ammonia, bile acids, creatinine, and urea', 'dialysis flow rate', 'conjugated bilirubin and bile acid level reduction during MARS and SPAD sessions and tolerance of dialysis system devices', 'bile acid levels']","[{'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}, {'cui': 'C0074937', 'cui_str': 'SPAD'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1721147', 'cui_str': 'factor V clotting activity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0019212', 'cui_str': 'Hepatorenal syndrome'}]","[{'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0236556', 'cui_str': 'Direct reacting bilirubin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}, {'cui': 'C0074937', 'cui_str': 'SPAD'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",,0.12437,"Baseline biochemical characteristics (bilirubin, ammonia, bile acids, creatinine, and urea) were not statistically different between MARS and SPAD.","[{'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Wallon', 'Affiliation': ""Département d'Anesthésie-Réanimation, Centre Léon Bérard, Lyon, France.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Guth', 'Affiliation': ""Département d'Anesthésie-Réanimation, Hôpital d'Instruction des Armées Percy, Clamart, France.""}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Guichon', 'Affiliation': ""Département d'Anesthésie-Réanimation, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France.""}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Thevenon', 'Affiliation': 'Centre de Recherche Clinique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Gazon', 'Affiliation': ""Département d'Anesthésie-Réanimation, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France.""}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Viale', 'Affiliation': ""Département d'Anesthésie-Réanimation, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France.""}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Schoeffler', 'Affiliation': ""Département d'Anesthésie-Réanimation, Centre Hospitalier de Montélimar, Montélimar, France.""}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Duperret', 'Affiliation': ""Département d'Anesthésie-Réanimation, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France.""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Aubrun', 'Affiliation': ""Département d'Anesthésie-Réanimation, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France.""}]",Blood purification,['10.1159/000515825']
534,34137199,Vaginal stimulation enhances ovulation of queen ovaries treated using a combination of eCG and hCG.,"Follicular changes throughout the oestrous phase have been poorly documented in queens because of the location and the small size of ovaries. We investigated follicular development in queens treated with a combination of equine chorionic gonadotropin (eCG) and human chorionic gonadotropin (hCG) and evaluated the effects of vaginal stimulation by a tomcat on ovulation induction. A hormonal treatment was administered using a simple crossover design. Four queens were administered 150 IU of eCG (day 1) and 250 IU of hCG on day 5 and 6. Half of the queens were mated with a vasectomised tomcat for 3 days after hCG injection. Ultrasound imaging of the ovaries clamped at a subcutaneous site was performed once a day from day 1 to 7, and on day 13, and the serum concentrations of oestradiol and progesterone were examined on day 1, 5, 7 and 13. The mean number of follicles gradually increased with the eCG treatment and decreased after hCG injection. The ovulation rate of follicles was significantly higher in the vaginal stimulation group (70.0%) than in the control group (42.6%). During the hormonal treatments, the serum concentration of oestradiol and progesterone did not differ between the two groups. Ultrasound imaging of the ovaries clamped at a subcutaneous site showed that eCG and hCG treatment promoted the follicular growth and corpus luteum formation, respectively. The combination of hCG injection with vaginal stimulation by a vasectomised tomcat enhanced the ovulation rate of follicles.",2021,The ovulation rate of follicles was significantly higher in the vaginal stimulation group (70.0%) than in the control group (42.6%).,[],"['equine chorionic gonadotropin (eCG) and human chorionic gonadotropin (hCG', 'eCG and hCG', 'hCG injection with vaginal stimulation', 'hCG']","['ovulation rate of follicles', 'mean number of follicles', 'serum concentrations of oestradiol and progesterone', 'Vaginal stimulation enhances ovulation', 'follicular growth and corpus luteum formation', 'serum concentration of oestradiol and progesterone']",[],"[{'cui': 'C0018064', 'cui_str': 'Equine Gonadotropins'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0010092', 'cui_str': 'Structure of corpus luteum of ovary'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",4.0,0.0473769,The ovulation rate of follicles was significantly higher in the vaginal stimulation group (70.0%) than in the control group (42.6%).,"[{'ForeName': 'Naoaki', 'Initials': 'N', 'LastName': 'Yoshimura', 'Affiliation': 'Laboratory of Animal Reproduction, Faculty of Bioscience and Bioindustry, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Taniguchi', 'Affiliation': 'The United Graduate School of Veterinary Science, Yamaguchi University, Yamaguchi, Japan.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Terazono', 'Affiliation': 'The United Graduate School of Veterinary Science, Yamaguchi University, Yamaguchi, Japan.'}, {'ForeName': 'Tetsushi', 'Initials': 'T', 'LastName': 'Ono', 'Affiliation': 'The United Graduate School of Veterinary Science, Yamaguchi University, Yamaguchi, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Takagi', 'Affiliation': 'The United Graduate School of Veterinary Science, Yamaguchi University, Yamaguchi, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Biological Science, School of Biological Science, Tokai University, Hokkaido, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Hirata', 'Affiliation': 'Laboratory of Animal Reproduction, Faculty of Bioscience and Bioindustry, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Fuminori', 'Initials': 'F', 'LastName': 'Tanihara', 'Affiliation': 'Laboratory of Animal Reproduction, Faculty of Bioscience and Bioindustry, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Takeshige', 'Initials': 'T', 'LastName': 'Otoi', 'Affiliation': 'Laboratory of Animal Reproduction, Faculty of Bioscience and Bioindustry, Tokushima University, Tokushima, Japan.'}]",Veterinary medicine and science,['10.1002/vms3.552']
535,34137177,Autologous versus allogeneic versus umbilical cord sera for the treatment of severe dry eye disease: a double-blind randomized clinical trial.,"PURPOSE


To measure the effects of Autologous serum (AS), Allogeneic Serum (HS) and Umbilical Cord serum (CS) eye drops in severe dry eye disease (DES), as well as to characterize and quantify several molecules in the three sera (albumin, fibronectin; Vitamin A and E; IgG, IgA and IgM; Transforming growth factor β; Epithelial growth factor).
METHODS


Randomized, double-blind, single-centre, three-arm (AS, HS and CS) clinical trial. Sixty-three subjects were included with severe DES, 21 in each arm of the study. Visual acuity, Schirmer test, Breakup time (BUT), lissamine green, fluorescein staining measurements and a questionnaire were performed prior to treatment, and after one-month and three-month follow-up.
RESULTS


There was a significant main effect of time on visual acuities, Schirmer and BUT tests and fluorescein and lissamine green staining measurements and questionnaire scores (p = 0.015, p = 0.002, p < 0.001, p < 0.001, p = 0.031 and p < 0.001, respectively), although there was no significant interaction between time and serum type, nor between serum type and the test performed. Regarding the concentration of molecules, in our study AS contained significantly higher concentrations of IgA, IgG and fibronectin whereas HS contained significantly higher concentration of IgM, vitamins A and E, TGF and albumin. Contrary to previous reports, CS did not show higher concentration of any of the molecules analysed.
CONCLUSIONS AND RELEVANCE


The three sera were effective in the treatment of severe DES. CS did not contain a higher proportion of molecules compared to AS/HS. More research is needed to assess the effect of AS in patients with DES and autoimmune diseases.",2022,"There was a significant main effect of time on visual acuities, Schirmer and BUT tests and fluorescein and lissamine green staining measurements and questionnaire scores (p = 0.015, p = ","['Sixty-three subjects were included with severe DES, 21 in each arm of the study', 'severe dry eye disease', 'patients with DES and autoimmune diseases']",['Autologous versus allogeneic versus umbilical cord sera'],"['IgM, vitamins A and E, TGF and albumin', 'concentrations of IgA, IgG and fibronectin', 'Autologous serum (AS), Allogeneic Serum (HS) and Umbilical Cord serum (CS) eye drops in severe dry eye disease (DES', 'visual acuities, Schirmer and BUT tests and fluorescein and lissamine green staining measurements and questionnaire scores', 'Visual acuity, Schirmer test, Breakup time (BUT), lissamine green, fluorescein staining measurements and a questionnaire']","[{'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]","[{'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0016055', 'cui_str': 'Fibronectin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}]",63.0,0.308254,"There was a significant main effect of time on visual acuities, Schirmer and BUT tests and fluorescein and lissamine green staining measurements and questionnaire scores (p = 0.015, p = ","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Rodríguez Calvo-de-Mora', 'Affiliation': 'Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.'}, {'ForeName': 'Cayetano', 'Initials': 'C', 'LastName': 'Domínguez-Ruiz', 'Affiliation': 'Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Barrero-Sojo', 'Affiliation': 'Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Rodríguez-Moreno', 'Affiliation': 'Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Antúnez Rodríguez', 'Affiliation': 'Centro Regional de Transfusiones, Málaga, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ponce Verdugo', 'Affiliation': 'Centro Regional de Transfusiones, Málaga, Spain.'}, {'ForeName': 'María Del Carmen', 'Initials': 'MDC', 'LastName': 'Hernández Lamas', 'Affiliation': 'Centro Regional de Transfusiones, Málaga, Spain.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Hernández-Guijarro', 'Affiliation': 'Hospital Quirón Salud, Málaga, Spain.'}, {'ForeName': 'Jacinto', 'Initials': 'J', 'LastName': 'Villalvilla Castillo', 'Affiliation': 'Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.'}, {'ForeName': 'Idefonso', 'Initials': 'I', 'LastName': 'Fernández-Baca Casares', 'Affiliation': 'Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.'}, {'ForeName': 'Isidro', 'Initials': 'I', 'LastName': 'Prat Arrojo', 'Affiliation': 'Centro Regional de Transfusiones, Málaga, Spain.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Borroni', 'Affiliation': 'The Veneto Eye Bank Foundation, Venice, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Alba-Linero', 'Affiliation': 'Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Zamorano-Martín', 'Affiliation': 'Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Moreno-Guerrero', 'Affiliation': 'Ophthalmology Department, Málaga University, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Rocha-de-Lossada', 'Affiliation': 'Qvision, Department of Ophthalmology, Vithas, Almería, Spain.'}]",Acta ophthalmologica,['10.1111/aos.14953']
536,34131048,Baseline Predictors of Glycemic Worsening in Youth and Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes in the Restoring Insulin Secretion (RISE) Study.,"OBJECTIVE


To identify predictors of glycemic worsening among youth and adults with impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes in the Restoring Insulin Secretion (RISE) Study.
RESEARCH DESIGN AND METHODS


A total of 91 youth (10-19 years) were randomized 1:1 to 12 months of metformin (MET) or 3 months of glargine, followed by 9 months of metformin (G-MET), and 267 adults were randomized to MET, G-MET, liraglutide plus MET (LIRA+MET), or placebo for 12 months. All participants underwent a baseline hyperglycemic clamp and a 3-h oral glucose tolerance test (OGTT) at baseline, month 6, month 12, and off treatment at month 15 and month 21. Cox models identified baseline predictors of glycemic worsening (HbA 1c  increase ≥0.5% from baseline).
RESULTS


Glycemic worsening occurred in 17.8% of youth versus 7.5% of adults at month 12 ( P  = 0.008) and in 36% of youth versus 20% of adults at month 21 ( P  = 0.002). In youth, glycemic worsening did not differ by treatment. In adults, month 12 glycemic worsening was less on LIRA+MET versus placebo (hazard ratio 0.21, 95% CI 0.05-0.96,  P  = 0.044). In both age-groups, lower baseline clamp-derived β-cell responses predicted month 12 and month 21 glycemic worsening ( P  < 0.01). Lower baseline OGTT-derived β-cell responses predicted month 21 worsening ( P  < 0.05). In youth, higher baseline HbA 1c  and 2-h glucose predicted month 12 and month 21 glycemic worsening, and higher fasting glucose predicted month 21 worsening ( P  < 0.05). In adults, lower clamp- and OGTT-derived insulin sensitivity predicted month 12 and month 21 worsening ( P  < 0.05).
CONCLUSIONS


Glycemic worsening was more common among youth than adults with IGT or recently diagnosed type 2 diabetes, predicted by lower baseline β-cell responses in both groups, hyperglycemia in youth, and insulin resistance in adults.",2021,"In adults, month 12 glycemic worsening was less on LIRA+MET versus placebo (hazard ratio 0.21, 95% CI 0.05-0.96,  P  = 0.044).","['A total of 91 youth (10-19 years', 'youth and adults with impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes in the Restoring Insulin Secretion (RISE) Study', '267 adults', 'Youth and Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes in the Restoring Insulin Secretion (RISE) Study']","['LIRA+MET versus placebo', 'liraglutide plus MET (LIRA+MET), or placebo', 'metformin (MET) or 3 months of glargine, followed by 9 months of metformin (G-MET', 'baseline hyperglycemic clamp and a 3-h oral glucose tolerance test (OGTT']",['Glycemic worsening'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517672', 'cui_str': '267'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}]",267.0,0.277001,"In adults, month 12 glycemic worsening was less on LIRA+MET versus placebo (hazard ratio 0.21, 95% CI 0.05-0.96,  P  = 0.044).","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Sam', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'George Washington University Biostatistics Center, Washington, DC.'}, {'ForeName': 'Silva A', 'Initials': 'SA', 'LastName': 'Arslanian', 'Affiliation': ""University of Pittsburgh Medical Center-Children's Hospital of Pittsburgh, Pittsburgh, PA.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barengolts', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': 'University of Southern California Keck School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Caprio', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ehrmann', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Tamara S', 'Initials': 'TS', 'LastName': 'Hannon', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Ashley Hogan', 'Initials': 'AH', 'LastName': 'Tjaden', 'Affiliation': 'George Washington University Biostatistics Center, Washington, DC.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Veterans Affairs Puget Sound Health Care System and University of Washington, Seattle, WA.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tripputi', 'Affiliation': 'George Washington University Biostatistics Center, Washington, DC.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'Veterans Affairs Puget Sound Health Care System and University of Washington, Seattle, WA.'}, {'ForeName': 'Anny H', 'Initials': 'AH', 'LastName': 'Xiang', 'Affiliation': 'Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc21-0027']
537,34121047,Distinct effects of carbohydrate ingestion timing on glucose fluctuation and energy metabolism in patients with type 2 diabetes: a randomized controlled study.,"This randomized, open-label, and parallel-group study aimed to investigate the effects of altering the timing of carbohydrate intake at breakfast or dinner on blood glucose fluctuations and energy metabolism. A total of 43 participants with type 2 diabetes were assigned to either the breakfast or dinner group. Participants were provided an isocaloric carbohydrate-restricted diet constituting 10% carbohydrate only at breakfast or dinner for 2 days during the study. Glucose fluctuations were compared using a continuous glucose monitoring system (iPro2) and body composition, energy expenditure, blood biochemistry, and endocrine function changes. The carbohydrate restriction either at breakfast or dinner significantly decreased postprandial glucose excursion and mean 24-h blood glucose levels. The incremental blood glucose area under the curve (AUC) for 2 h (iAUC0-2h) at lunch significantly increased in the breakfast group, whereas no significant differences were observed in the iAUC0-2h between breakfast and lunch in the dinner group. Carbohydrate restriction reduced diet-induced thermogenesis at breakfast (intragroup comparison; 223 ± 117 to 109 ± 104 kcal, p = 0.002) but did not affect diet-induced thermogenesis at dinner. However, fasting plasma free fatty acids were comparable in both groups, prelunch free fatty acids increased significantly only in the breakfast group (0.20 ± 0.09 to 0.63 ± 0.19 mEq/L, p < 0.001). Carbohydrate restriction in the diet once daily decreases mean 24-h blood glucose levels and exerts unique metabolic effects depending on the timing.",2021,"Carbohydrate restriction reduced diet-induced thermogenesis at breakfast (intragroup comparison; 223 ± 117 to 109 ± 104 kcal, p = 0.002) but did not affect diet-induced thermogenesis at dinner.","['patients with type 2 diabetes', '43 participants with type 2 diabetes']","['carbohydrate intake at breakfast or dinner', 'carbohydrate ingestion', 'isocaloric carbohydrate-restricted diet constituting 10% carbohydrate only at breakfast or dinner']","['glucose fluctuation and energy metabolism', 'blood glucose fluctuations and energy metabolism', 'incremental blood glucose area under the curve (AUC', 'continuous glucose monitoring system (iPro2) and body composition, energy expenditure, blood biochemistry, and endocrine function changes', 'postprandial glucose excursion and mean 24-h blood glucose levels', 'Glucose fluctuations', 'mean 24-h blood glucose levels', 'fasting plasma free fatty acids', 'prelunch free fatty acids']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0877314', 'cui_str': 'Blood glucose fluctuation'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0678896', 'cui_str': 'Endocrine function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}]",43.0,0.0147207,"Carbohydrate restriction reduced diet-induced thermogenesis at breakfast (intragroup comparison; 223 ± 117 to 109 ± 104 kcal, p = 0.002) but did not affect diet-induced thermogenesis at dinner.","[{'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Enyama', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Ishikawa 920-8640, Japan.'}, {'ForeName': 'Yumie', 'Initials': 'Y', 'LastName': 'Takeshita', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Ishikawa 920-8640, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Ishikawa 920-8640, Japan.'}, {'ForeName': 'Saori', 'Initials': 'S', 'LastName': 'Sako', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Ishikawa 920-8640, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Kanamori', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Ishikawa 920-8640, Japan.'}, {'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Takamura', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Ishikawa 920-8640, Japan.'}]",Endocrine journal,['10.1507/endocrj.EJ20-0623']
538,34127294,Non-specific effects of rabies vaccine on the incidence of self-reported common infectious disease episodes: A randomized controlled trial.,"Vaccines may affect recipients' immune systems in ways that change morbidity or mortality rates to unrelated infections in vaccinated populations. It has been proposed that these non-specific effects differ by type of vaccine and by sex, with non-live vaccines enhancing susceptibility of females to unrelated infections, and live vaccines enhancing resistance in both sexes. Rabies vaccine-a non-live vaccine-has been associated with protection against unrelated central nervous system infections. Data from randomized controlled trials are needed to assess this effect against other illnesses. This phase IV, single-site, participant-blinded, randomized, placebo-controlled trial in a population of veterinary students on the rabies-free island of St. Kitts assessed the effect of a primary course of rabies vaccine on the incidence rate of weekly self-reported new episodes of common infectious disease (CID) syndromes, defined as a new episode of any one of the following syndromes in a particular week: upper respiratory illness (URI), influenza-like illness (ILI), diarrheal illness (DIA) or undifferentiated febrile illness (UFI). As a secondary objective, we tested for modification of the effect of rabies vaccine on study outcomes by sex. 546 participants were randomized (274 to rabies vaccine and 272 to placebo). No statistically significant differences between groups were observed for any study outcomes: CID incidence rate ratio (IRR) 0.95 (95% CI 0.77-1.18); URI IRR 1.15 (95% CI 0.86-1.54); ILI IRR 0.83 (95% CI 0.54-1.27); DIA IRR 0.93 (95% CI 0.70-1.24) and UFI IRR 1.09 (95% CI 0.48-2.44). In a secondary analysis, there was little evidence that sex modified the effect of vaccination on any of the evaluated outcomes, although the power to detect this was low. In conclusion, rabies vaccine did not provide protection against mild self-reported illness among a young and healthy group of adults attending veterinary school. Clinical trial registration. ClinicalTrials.gov: NCT03656198.",2022,No statistically significant differences between groups were observed for any study outcomes: CID incidence rate ratio (IRR) 0.95,['546 participants were randomized (274 to'],"['placebo', 'rabies vaccine and 272 to placebo', 'rabies vaccine', 'Rabies vaccine-a non-live vaccine']","['upper respiratory illness (URI), influenza-like illness (ILI), diarrheal illness (DIA) or undifferentiated febrile illness (UFI', 'study outcomes: CID incidence rate ratio (IRR) 0.95']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034496', 'cui_str': 'Rabies vaccine'}, {'cui': 'C0042211', 'cui_str': 'Vaccines, Live, Attenuated'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C0743841', 'cui_str': 'Disorder characterized by fever'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",546.0,0.66566,No statistically significant differences between groups were observed for any study outcomes: CID incidence rate ratio (IRR) 0.95,"[{'ForeName': 'Christianah I', 'Initials': 'CI', 'LastName': 'Odita', 'Affiliation': 'Department of Veterinary Tropical Diseases, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Conan', 'Affiliation': 'Department of Biomedical Sciences, Ross University School of Veterinary Medicine, Basseterre, Saint Kitts and Nevis; Center for One Health Research and Policy Advice, City University of Hong Kong, Kowloon, Hong Kong Special Administrative Region.'}, {'ForeName': 'Marshalette', 'Initials': 'M', 'LastName': 'Smith-Antony', 'Affiliation': 'Department of Biomedical Sciences, Ross University School of Veterinary Medicine, Basseterre, Saint Kitts and Nevis.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Battice', 'Affiliation': 'Department of Biomedical Sciences, Ross University School of Veterinary Medicine, Basseterre, Saint Kitts and Nevis.'}, {'ForeName': 'Shianne', 'Initials': 'S', 'LastName': 'England', 'Affiliation': 'Department of Biomedical Sciences, Ross University School of Veterinary Medicine, Basseterre, Saint Kitts and Nevis.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Barry', 'Affiliation': 'Department of Biomedical Sciences, Ross University School of Veterinary Medicine, Basseterre, Saint Kitts and Nevis.'}, {'ForeName': 'Bradford D', 'Initials': 'BD', 'LastName': 'Gessner', 'Affiliation': 'EpiVac Consulting Services, Anchorage, AK, United States.'}, {'ForeName': 'Darryn L', 'Initials': 'DL', 'LastName': 'Knobel', 'Affiliation': 'Department of Veterinary Tropical Diseases, University of Pretoria, Pretoria, South Africa; Department of Biomedical Sciences, Ross University School of Veterinary Medicine, Basseterre, Saint Kitts and Nevis. Electronic address: dknobel@rossvet.edu.kn.'}]",Vaccine,['10.1016/j.vaccine.2021.06.007']
539,34126156,Novel antibody cocktail targeting Bet v 1 rapidly and sustainably treats birch allergy symptoms in a phase 1 study.,"BACKGROUND


The efficacy of an allergen-specific IgG cocktail to treat cat allergy suggests that allergen-specific IgG may be a major protective mechanism elicited by allergen immunotherapy.
OBJECTIVES


Extending these findings, we tested a Bet v 1-specific antibody cocktail in birch-allergic subjects.
METHODS


This was a phase 1, randomized, double-blind, study with 2 parts. Part A administered ascending doses of the Bet v 1-specific antibody cocktail REGN5713/14/15 (150-900 mg) in 32 healthy adults. Part B administered a single subcutaneous 900-mg dose or placebo in 64 birch-allergic subjects. Total nasal symptom score response to titrated birch extract nasal allergen challenge and skin prick test (SPT) with birch and alder allergen were assessed at screening and days 8, 29, 57, and 113 (SPT only); basophil activation tests (n = 26) were conducted.
RESULTS


Single-dose REGN5713/14/15 significantly reduced total nasal symptom score following birch nasal allergen challenge relative to baseline. Differences in total nasal symptom score areas under the curve (0-1 hour) for subjects treated with REGN5713/14/15 versus those given placebo (day 8: -1.17, P = .001; day 29: -1.18, P = .001; day 57: -0.85, P = .024) and titration SPT with birch difference in area under the curve of mean wheal diameters for subjects treated with REGN5713/14/15 versus placebo (all P < .001) were sustained for ≥2 months; similar results were observed with alder SPT. REGN5713/14/15 was well tolerated. Basophil responsiveness to birch-related allergens was significantly decreased in subjects treated with REGN5713/14/15 versus those given placebo on days 8, 57, and 113 (all P < .01).
CONCLUSIONS


Single-dose REGN5713/14/15 was well tolerated and provided a rapid (1 week) and durable (2 months) reduction in allergic symptoms after birch allergen nasal allergen challenge, potentially offering a new paradigm for the treatment of birch allergy symptoms.",2022,"Basophil responsiveness to birch-related allergens was significantly decreased in REGN5713/14/15-treated subjects versus placebo on days 8, 57, and 113 (all P < .01).
","['64 birch-allergic subjects', 'birch-allergic subjects', '32 healthy adults']","['placebo', 'TNSS', 'Part-B, single subcutaneous 900 mg dose or placebo', 'Bet v 1-specific antibody cocktail ""REGN5713/14/15']","['Basophil responsiveness', 'TNSS', 'allergic symptoms', 'tolerated', 'Total nasal symptom score (TNSS) response to titrated birch extract nasal allergen challenge (NAC) and skin prick test (SPT) with birch and alder allergen']","[{'cui': 'C0330312', 'cui_str': 'Betula'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}]","[{'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0330312', 'cui_str': 'Betula'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0259780', 'cui_str': 'Alder-Reilly body'}]",32.0,0.137278,"Basophil responsiveness to birch-related allergens was significantly decreased in REGN5713/14/15-treated subjects versus placebo on days 8, 57, and 113 (all P < .01).
","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gevaert', 'Affiliation': 'Department of Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'De Craemer', 'Affiliation': 'Department of Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'De Ruyck', 'Affiliation': 'Department of Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Rottey', 'Affiliation': 'Drug Research Unit Ghent, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'de Hoon', 'Affiliation': 'Center for Clinical Pharmacology, UZ Leuven, Leuven, Belgium.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Hellings', 'Affiliation': 'Department of Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium; Allergy and Clinical Immunology Research Group, KU Leuven, Leuven, Belgium; Academic Medical Center Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Volckaert', 'Affiliation': 'SGS Belgium Clinical Pharmacology Unit Antwerpen, Antwerp, Belgium.'}, {'ForeName': 'Kristof', 'Initials': 'K', 'LastName': 'Lesneuck', 'Affiliation': 'SGS Belgium Clinical Pharmacology Unit Antwerpen, Antwerp, Belgium.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Orengo', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Atanasio', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Kamal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'Abdallah', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Kamat', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dingman', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'DeVeaux', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Ramesh', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Lorah', 'Initials': 'L', 'LastName': 'Perlee', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Claire Q', 'Initials': 'CQ', 'LastName': 'Wang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Herman', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY.'}, {'ForeName': 'Meagan P', 'Initials': 'MP', 'LastName': ""O'Brien"", 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY. Electronic address: meagan.obrien@regeneron.com.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2021.05.039']
540,34139356,PROState Pathway Embedded Comparative Trial: The IP3-PROSPECT study.,"INTRODUCTION


The traditional double blind RCT is the 'gold standard' trial design. For a variety of reasons, these designs often fail to accrue enough participants to conclude. This is particularly challenging in localized prostate cancer. The cohort multiple randomised controlled trial (cmRCT) trial design may represent an alternative approach to delivering robust comparative data in prostate cancer.
PATIENTS AND METHODS


IP3-PROSPECT is a cmRCT designed to test multiple prostate cancer interventions from eligible men in one cohort. Key to the design is two points of consent. First, at point of consent one, men referred for prostate cancer investigations are invited to join the cohort. They may then be randomly invited at a later date to consider an intervention at point of consent two. In the pilot phase we will test the acceptability and feasibility of developing the cohort.
RESULTS


Acceptability and feasibility of the study will be measured by a combination of quantitative and qualitative methods. The primary outcome measure is the rate of consent to inclusion to the IP3-PROSPECT cohort. Secondary outcome measures include the completeness of data collection at sites and return rates of patient questionnaires. We will also interview patients and healthcare professionals to explore their thoughts on the implementation, practicality and efficiency of IP3-PROSPECT.
CONCLUSION


The IP3-PROSPECT study will evaluate the cmRCT design in prostate cancer. Initially we will pilot the design, assessing for acceptability and feasibility. The cmRCT is an innovative design that offers potential for building a modern comparative evidence base for prostate cancer.",2021,"We will also interview patients and healthcare professionals to explore their thoughts on the implementation, practicality and efficiency of IP3-PROSPECT.
",['eligible men in one cohort'],[],"['completeness of data collection at sites and return rates of patient questionnaires', 'rate of consent to inclusion to the IP3-PROSPECT cohort']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0021549', 'cui_str': '1,4,5-IP3'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",,0.432134,"We will also interview patients and healthcare professionals to explore their thoughts on the implementation, practicality and efficiency of IP3-PROSPECT.
","[{'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Bass', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Imperial Urology, Division of Cancer, Cardiovascular Medicine and Surgery, Imperial College Healthcare NHS Trust, London, UK. Electronic address: ebass@ic.ac.uk.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Klimowska-Nassar', 'Affiliation': 'Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sasikaran', 'Affiliation': 'Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Day', 'Affiliation': 'Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Fiorentino', 'Affiliation': 'Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit at UCL, University College London, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Winkler', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Imperial Urology, Division of Cancer, Cardiovascular Medicine and Surgery, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Arumainayagam', 'Affiliation': ""Department of Urology, Ashford and St. Peter's Hospitals NHS Foundation Trust, St. Peter's Hospital, Chertsey, UK.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Khoubehi', 'Affiliation': 'Imperial Urology, Division of Cancer, Cardiovascular Medicine and Surgery, Imperial College Healthcare NHS Trust, London, UK; Department of Urology, Chelsea and Westminster Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pope', 'Affiliation': 'Imperial Urology, Division of Cancer, Cardiovascular Medicine and Surgery, Imperial College Healthcare NHS Trust, London, UK; Department of Urology, The Hillingdon Hospitals NHS Foundation Trust, Uxbridge, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sokhi', 'Affiliation': 'Department of Radiology, The Hillingdon Hospitals NHS Foundation Trust, Uxbridge, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Dudderidge', 'Affiliation': 'Department of Urology, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'H U', 'Initials': 'HU', 'LastName': 'Ahmed', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Imperial Urology, Division of Cancer, Cardiovascular Medicine and Surgery, Imperial College Healthcare NHS Trust, London, UK.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106485']
541,34143803,Evaluation of an integrated intervention to reduce psychological distress and intimate partner violence in refugees: Results from the Nguvu cluster randomized feasibility trial.,"INTRODUCTION


The complex relationship between intimate partner violence and psychological distress warrants an integrated intervention approach. In this study we examined the relevance, acceptability, and feasibility of evaluating a multi-sectoral integrated violence- and mental health-focused intervention (Nguvu).
METHODS


We enrolled 311 Congolese refugee women from Nyarugusu refugee camp in Tanzania with past-year intimate partner violence and elevated psychological distress in a feasibility cluster randomized trial. Women were recruited from local women's groups that were randomized to the Nguvu intervention or usual care. Participants from women's groups randomized to Nguvu received 8 weekly sessions delivered by lay refugee incentive workers. Psychological distress, intimate partner violence, other wellbeing, and process indicators were assessed at baseline and 9-weeks post-enrollment to evaluate relevance, acceptability, and feasibility of implementing and evaluating Nguvu in refugee contexts.
RESULTS


We found that Nguvu was relevant to the needs of refugee women affected by intimate partner violence. We found reductions in some indicators of psychological distress, but did not identify sizeable changes in partner violence over time. Overall, we found that Nguvu was acceptable and feasible. However, challenges to the research protocol included baseline imbalances between study conditions, differential intervention completion related to intimate partner violence histories, differences between Nguvu groups and facilitators, and some indication that Nguvu may be less beneficial for participants with more severe intimate partner violence profiles.
CONCLUSIONS


We found evidence supporting the relevance of Nguvu to refugee women affected by partner violence and psychological distress and moderate evidence supporting the acceptability and feasibility of evaluating and implementing this intervention in a complex refugee setting. A definitive cluster randomized trial requires further adaptations for recruitment and eligibility screening, randomization, and retention.
TRIAL REGISTRATION


ISRCTN65771265, June 27, 2016.",2021,We found evidence supporting the relevance of Nguvu to refugee women affected by partner violence and psychological distress and moderate evidence supporting the acceptability and feasibility of evaluating and implementing this intervention in a complex refugee setting.,"['311 Congolese refugee women from Nyarugusu refugee camp in Tanzania with past-year intimate partner violence and elevated psychological distress in a feasibility cluster randomized trial', 'participants with more severe intimate partner violence profiles', ""Women were recruited from local women's groups"", 'psychological distress and intimate partner violence in refugees']","['multi-sectoral integrated violence- and mental health-focused intervention (Nguvu', 'integrated intervention', 'Nguvu intervention or usual care', 'Nguvu received 8 weekly sessions delivered by lay refugee incentive workers']","['partner violence', 'relevance, acceptability, and feasibility of implementing and evaluating Nguvu in refugee contexts', 'psychological distress', 'Psychological distress, intimate partner violence, other wellbeing, and process indicators']","[{'cui': 'C0337830', 'cui_str': 'Congolese'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242477', 'cui_str': 'Refugee Camps'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0242543', 'cui_str': ""Women's Groups""}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439741', 'cui_str': 'Sectoral'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",311.0,0.0603717,We found evidence supporting the relevance of Nguvu to refugee women affected by partner violence and psychological distress and moderate evidence supporting the acceptability and feasibility of evaluating and implementing this intervention in a complex refugee setting.,"[{'ForeName': 'M Claire', 'Initials': 'MC', 'LastName': 'Greene', 'Affiliation': 'Program on Forced Migration and Health, Columbia University Mailman School of Public Health, New York, New York, United States of America.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Likindikoki', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Rees', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Bonz', 'Affiliation': 'HIAS, Silver Spring, Maryland, United States of America.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kaysen', 'Affiliation': 'Department Psychiatry, Public Mental Health and Population Sciences, Stanford University, Palo Alto, California, United States of America.'}, {'ForeName': 'Lusia', 'Initials': 'L', 'LastName': 'Misinzo', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Tasiana', 'Initials': 'T', 'LastName': 'Njau', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Shangwe', 'Initials': 'S', 'LastName': 'Kiluwa', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Turner', 'Affiliation': 'Department of Community-Public Health, Johns Hopkins School of Nursing, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ventevogel', 'Affiliation': 'Public Health Section, United Nations High Commissioner for Refugees, Geneva, Switzerland.'}, {'ForeName': 'Jessie K K', 'Initials': 'JKK', 'LastName': 'Mbwambo', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Wietse A', 'Initials': 'WA', 'LastName': 'Tol', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States of America.'}]",PloS one,['10.1371/journal.pone.0252982']
542,34149867,Aerobic exercise reduces anxiety and fear ratings to threat and increases circulating endocannabinoids in women with and without PTSD.,"Reductions in state anxiety have been reported following an acute bout of aerobic exercise. However, less is known regarding anxiety and fear ratings to specific threatening stimuli following an acute bout of aerobic exercise in women with PTSD. Moreover, the mechanisms responsible for the anxiolytic effects of exercise are not fully understood, although recent studies suggest a role for the endocannabinoid (eCB) system. Thus, this study utilized a randomized, counterbalanced approach to examine anxiety and fear ratings to predictable or unpredictable electric shock administration and circulating concentrations of eCBs and mood states immediately following moderate-intensity aerobic exercise (30 min on treadmill at 70-75% maximum heart rate) and a quiet rest control condition in women with and without a history of trauma, and in women with PTSD (N=42). Results revealed that anxiety and fear ratings to unpredictable and predictable threats were significantly ( p <.05) lower following exercise compared to quiet rest, with correlational analyses indicating those with greater increases in circulating eCBs had greater reductions in anxiety and fear ratings to unpredictable and predictable threats following exercise. Also, there were significant ( p <.05) reductions in fatigue, confusion, total mood disturbance, and increases in positive affect following exercise for the entire sample. Non-trauma controls and PTSD groups reported significant ( p <.05) increases in vigor, with additional mood improvements following exercise for the PTSD group (i.e., decreases in state anxiety, negative affect, tension, anger, and depression). Results from this study suggest that aerobic exercise exerts psychological benefits in women with PTSD, potentially due to exercise-induced increases in circulating concentrations of eCBs.",2021,"Results revealed that anxiety and fear ratings to unpredictable and predictable threats were significantly ( p <.05) lower following exercise compared to quiet rest, with correlational analyses indicating those with greater increases in circulating eCBs had greater reductions in anxiety and fear ratings to unpredictable and predictable threats following exercise.","['women with and without a history of trauma, and in women with PTSD (N=42', 'women with and without PTSD', 'women with PTSD']","['aerobic exercise', 'moderate-intensity aerobic exercise (30 min on treadmill at 70-75% maximum heart rate) and a quiet rest control condition', 'Aerobic exercise']","['anxiety and fear ratings to threat and increases circulating endocannabinoids', 'circulating concentrations of eCBs', 'anxiety and fear ratings to unpredictable and predictable threats', 'anxiety and fear ratings', 'state anxiety, negative affect, tension, anger, and depression', 'fatigue, confusion, total mood disturbance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0424139', 'cui_str': 'Anxiety and fear'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}]",,0.0214195,"Results revealed that anxiety and fear ratings to unpredictable and predictable threats were significantly ( p <.05) lower following exercise compared to quiet rest, with correlational analyses indicating those with greater increases in circulating eCBs had greater reductions in anxiety and fear ratings to unpredictable and predictable threats following exercise.","[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Crombie', 'Affiliation': 'Department of Kinesiology at the University of Wisconsin-Madison, Madison, WI - USA.'}, {'ForeName': 'Josh M', 'Initials': 'JM', 'LastName': 'Cisler', 'Affiliation': 'Department of Psychiatry at the University of Wisconsin - Madison, Madison, WI - USA.'}, {'ForeName': 'Cecilia J', 'Initials': 'CJ', 'LastName': 'Hillard', 'Affiliation': 'Neuroscience Research Center and Department of Pharmacology and Toxicology at the Medical College of Wisconsin, Milwaukee, WI - USA.'}, {'ForeName': 'Kelli F', 'Initials': 'KF', 'LastName': 'Koltyn', 'Affiliation': 'Department of Kinesiology at the University of Wisconsin-Madison, Madison, WI - USA.'}]",Mental health and physical activity,['10.1016/j.mhpa.2020.100366']
543,34146521,A Randomized Controlled Trial of Heart Failure Disease Management in Skilled Nursing Facilities.,"OBJECTIVE


Patients discharged from the hospital to a skilled nursing facility (SNF) are not typically part of a heart failure disease management program (HF-DMP). The objective of this study is to determine if an HF-DMP in SNF improves outcomes for patients with HF.
DESIGN


Cluster-randomized controlled trial.
PARTICIPANTS


The trial was conducted in 47 SNFs, and 671 patients were enrolled (329 HF-DMP; 342 to usual care).
METHODS


The HF-DMP included documentation of ejection fraction, symptoms, weights, diet, medication optimization, education, and 7-day visit post SNF discharge. The composite outcome was all-cause hospitalization, emergency department visits, or mortality at 60 days. Secondary outcomes included the composite endpoint at 30 days, change in the Kansas City Cardiomyopathy Questionnaire and the Self-care of HF Index at 60 days. Rehospitalization and mortality rates were calculated as an exploratory outcome.
RESULTS


Mean age of the patients was 79 ± 10 years, 58% were women, and the mean ejection fraction was 51% ± 16%. At 30 and 60 days post SNF admission, the composite endpoint was not significant between DMP (29%) and usual care (32%) at 30 days and 60 days (43% vs 47%, respectively). The Kansas City Cardiomyopathy Questionnaire significantly improved in the HF-DMP vs usual care for the Physical Limitation (11.3 ± 2.9 vs 20.8 ± 3.6; P = .039) and Social Limitation subscales (6.0 ± 3.1 vs 17.9 ± 3.8; P = .016). Self-care of HF Index was not significant. The total number of events (composite endpoint) totaled 517 (231 in HF-DMP and 286 in usual care). Differences in the 60-day hospitalization rate [mean HF-DMP rate 0.43 (SE 0.03) vs usual care 0.54 (SE 0.05), P = .04] and mortality rate (HF-DMP 5.2% vs usual care 10.8%, P < .001) were significant.
CONCLUSIONS AND IMPLICATIONS


The composite endpoint was high for patients with HF in SNF regardless of group. Rehospitalization and mortality rates were reduced by the HF-DMP. HF-DMPs in SNFs may be beneficial to the outcomes of patients with HF. SNFs should consider structured HF-DMPs for their patients.",2022,"Differences in the 60-day hospitalization rate [mean HF-DMP rate 0.43 (SE 0.03) vs usual care 0.54 (SE 0.05), P ","['Patients discharged from the hospital to a skilled nursing facility (SNF) are not typically part of a heart failure disease management program (HF-DMP', 'Skilled Nursing Facilities', 'patients with HF', 'The trial was conducted in 47 SNFs, and 671 patients were enrolled (329 HF-DMP; 342 to usual care']",[],"['60-day hospitalization rate [mean HF-DMP rate', 'documentation of ejection fraction, symptoms, weights, diet, medication optimization, education, and 7-day visit post SNF discharge', 'Social Limitation subscales', 'composite endpoint at 30\xa0days, change in the Kansas City Cardiomyopathy Questionnaire and the Self-care of HF Index', 'mean ejection fraction', 'cause hospitalization, emergency department visits, or mortality at 60\xa0days', 'total number of events', 'Self-care of HF Index', 'usual care', 'Kansas City Cardiomyopathy Questionnaire', 'mortality rate', 'Rehospitalization and mortality rates']","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037265', 'cui_str': 'Skilled nursing facility'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C5191280', 'cui_str': '342'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0037265', 'cui_str': 'Skilled nursing facility'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}]",671.0,0.122859,"Differences in the 60-day hospitalization rate [mean HF-DMP rate 0.43 (SE 0.03) vs usual care 0.54 (SE 0.05), P ","[{'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Boxer', 'Affiliation': 'Institute for Health Research, Kaiser Permanente, Aurora, CO, USA; Division of Geriatric Medicine, University of Colorado School of Medicine, Aurora, CO, USA. Electronic address: Rebecca.S.Boxer@kp.org.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Dolansky', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Chaussee', 'Affiliation': 'Biostatistics and Informatics, Colorado School of Public Health, Aurora, CO, USA; Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Jon D', 'Initials': 'JD', 'LastName': 'Campbell', 'Affiliation': 'Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Daddato', 'Affiliation': 'Institute for Health Research, Kaiser Permanente, Aurora, CO, USA; Division of Geriatric Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Page', 'Affiliation': 'Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Fairclough', 'Affiliation': 'Biostatistics and Informatics, Colorado School of Public Health, Aurora, CO, USA; Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Gravenstein', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI, USA; Brown School of Public Health, Providence, RI, USA; Providence Veterans Administration Medical Center, Providence, RI, USA.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2021.05.023']
544,34151132,Randomized Phase II Study of 3 Months or 2 Years of Adjuvant Afatinib in Patients With Surgically Resected Stage I-III  EGFR -Mutant Non-Small-Cell Lung Cancer.,"For patients with surgically resected disease, multiple studies suggest a benefit of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in delaying cancer recurrence. The necessary duration of therapy for benefit is unknown.
MATERIALS AND METHODS


This randomized phase II study enrolled patients with completely resected stage IA-IIIB  EGFR -mutant non-small-cell lung cancer (American Joint Committee on Cancer 7th edition) after stage-appropriate standard-of-care adjuvant therapy. Patients were randomly assigned 1:1 to 3 months or 2 years of adjuvant afatinib starting at 30 mg by mouth daily. Computed tomography imaging was performed every 6 months for 3 years and then annually. The primary study end point for this planned 92-patient trial was recurrence rate at 2 years from randomization. A 20% improvement (from 70% with 3 months to 90% with 2 years) was targeted.
RESULTS


Forty-six patients enrolled and 45 were treated. The assigned course of afatinib treatment was completed by 96% (22/23) of patients in the 3-month group and only 41% (9/22) in the 2-year group. The 2-year recurrence-free survival (RFS) rates were 70% in the 3-month group and 81% in the 2-year group ( P  = .55). The median RFS was 42.8 months in the 3-month group and 58.6 months in the 2-year group. Side effects were consistent with those previously described for afatinib.
CONCLUSION


Recurrences at 2 years were 11% less common with 2 years versus 3 months of adjuvant afatinib. This difference did not meet the 20% primary study target, likely because of underaccrual and early drug discontinuation on the 2-year group. With the availability of osimertinib with better efficacy and tolerability than earlier-generation agents, the optimal duration of adjuvant EGFR TKI therapy remains an important question.",2021,The 2-year recurrence-free survival (RFS) rates were 70% in the 3-month group and 81% in the 2-year group ( P  = .55).,"['Patients', 'enrolled patients with completely resected stage IA-IIIB  EGFR -mutant non-small-cell lung cancer (American Joint Committee on Cancer 7th edition) after stage-appropriate standard-of-care adjuvant therapy', 'Forty-six patients enrolled and 45 were treated']","['Adjuvant Afatinib', 'epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs', 'Computed tomography imaging']","['2-year recurrence-free survival (RFS) rates', 'Recurrences', 'efficacy and tolerability', 'recurrence rate', 'Side effects', 'median RFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0456595', 'cui_str': 'Stage 1A'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",46.0,0.137312,The 2-year recurrence-free survival (RFS) rates were 70% in the 3-month group and 81% in the 2-year group ( P  = .55).,"[{'ForeName': 'Joel W', 'Initials': 'JW', 'LastName': 'Neal', 'Affiliation': 'Stanford Cancer Institute, Stanford, CA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Costa', 'Affiliation': 'Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Muzikansky', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Shrager', 'Affiliation': 'Stanford Cancer Institute, Stanford, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lanuti', 'Affiliation': 'Stanford Cancer Institute, Stanford, CA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Thoracic Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Kavitha J', 'Initials': 'KJ', 'LastName': 'Ramachandran', 'Affiliation': 'Stanford Cancer Institute, Stanford, CA.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Rangachari', 'Affiliation': 'Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Huberman', 'Affiliation': 'Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Zofia', 'Initials': 'Z', 'LastName': 'Piotrowska', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Kris', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Azzoli', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Lecia V', 'Initials': 'LV', 'LastName': 'Sequist', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Chaft', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.'}]",JCO precision oncology,['10.1200/PO.20.00301']
545,34160288,Effects of altitude and recombinant human erythropoietin on iron metabolism: a randomized controlled trial.,"Current markers of iron deficiency (ID), such as ferritin and hemoglobin, have shortcomings, and hepcidin and erythroferrone (ERFE) could be of clinical relevance in relation to early assessment of ID. Here, we evaluate whether exposure to altitude-induced hypoxia (2,320 m) alone, or in combination with recombinant human erythropoietin (rHuEPO) treatment, affects hepcidin and ERFE levels before alterations in routine ID biomarkers and stress erythropoiesis manifest. Two interventions were completed, each comprising a 4-wk baseline, a 4-wk intervention at either sea level or altitude, and a 4-wk follow-up. Participants ( n  = 39) were randomly assigned to 20 IU·kg body wt -1  rHuEPO or placebo injections every second day for 3 wk during the two intervention periods. Venous blood was collected weekly. Altitude increased ERFE ( P  ≤ 0.001) with no changes in hepcidin or routine iron biomarkers, making ERFE of clinical relevance as an early marker of moderate hypoxia. rHuEPO treatment at sea level induced a similar pattern of changes in ERFE ( P  < 0.05) and hepcidin levels ( P  < 0.05), demonstrating the impact of accelerated erythropoiesis and not of other hypoxia-induced mechanisms. Compared with altitude alone, concurrent rHuEPO treatment and altitude exposure induced additive changes in hepcidin ( P  < 0.05) and ERFE ( P  ≤ 0.001) parallel with increases in hematocrit ( P  < 0.001), demonstrating a relevant range of both hepcidin and ERFE. A poor but significant correlation between hepcidin and ERFE was found ( R 2  = 0.13,  P  < 0.001). The findings demonstrate that hepcidin and ERFE are more rapid biomarkers of changes in iron demands than routine iron markers. Finally, ERFE and hepcidin may be sensitive markers in an antidoping context.",2021,"Altitude increased ERFE (P≤0.001) with no changes in hepcidin or routine iron biomarkers, making ERFE of clinical relevance as an early marker of moderate hypoxia.",['Participants (n=39'],"['hepcidin and ERFE', 'rHuEPO', 'altitude-induced hypoxia (2,320 m) alone, or in combination with recombinant human erythropoietin (rHuEPO', '20 IU·kg bw -1  rHuEPO or placebo', 'altitude and recombinant human erythropoietin']","['Venous blood', 'Altitude increased ERFE', 'hepcidin and ERFE', 'iron metabolism']",[],"[{'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",39.0,0.0582371,"Altitude increased ERFE (P≤0.001) with no changes in hepcidin or routine iron biomarkers, making ERFE of clinical relevance as an early marker of moderate hypoxia.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Breenfeldt Andersen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Bonne', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bejder', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Jung', 'Affiliation': 'Department of Medicine and Pathology, Center for Iron Disorders, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Ganz', 'Affiliation': 'Department of Medicine and Pathology, Center for Iron Disorders, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Elizabeta', 'Initials': 'E', 'LastName': 'Nemeth', 'Affiliation': 'Department of Medicine and Pathology, Center for Iron Disorders, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Niels Vidiendal', 'Initials': 'NV', 'LastName': 'Olsen', 'Affiliation': 'Department of Neuroscience and Pharmacology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jesús Rodríguez', 'Initials': 'JR', 'LastName': 'Huertas', 'Affiliation': 'Department of Physiology, Faculty of Sport Sciences, Institute of Nutrition and Food Technology, Biomedical Research Centre, University of Granada, Armilla, Spain.'}, {'ForeName': 'Nikolai Baastrup', 'Initials': 'NB', 'LastName': 'Nordsborg', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00070.2021']
546,34154896,Treadmill versus overground gait training in patients with lower limb burn injury: A matched control study.,"INTRODUCTION


Gait impairment is commonly seen in patients with a lower limb burn injury (LLBI). Therefore, the aim of this study was to investigate the effects of two different gait training modes on gait symmetry, functional mobility and kinesiophobia in patients with LLBI.
METHODS


This matched control study was conducted between January 2017 and August 2018. Patients with LLBI (n=28) were allocated to 2 different groups by matching according to burn localization, age, and gender. Group 1 (overground group: n=14) received overground gait training in addition to standard burn rehabilitation, and Group 2 (treadmill group: n=14) received treadmill gait training in addition to standard burn rehabilitation. The rehabilitation program and gait training were started when the patient was admitted to the hospital and ended on discharge. These physical therapy interventions were performed 5 days per week. The gait training intensity, including walking speed and duration, was determined according to patient tolerance. Gait parameters, functional mobility, kinesiophobia and pain values were evaluated with GAITRite, the timed up-and-go test (TUG), Tampa Kinesiophobia Scale and Visual Analogue Scale, respectively. These evaluations were made twice; on admission and immediately prior to discharge. Gait symmetry was calculated using the Symmetry Index.
RESULTS


The baseline characteristics of the groups and initial outcome values were similar. In the comparison of the differences between the overground and treadmill groups, the change in kinesiophobia and TUG values were significantly higher in the treadmill group (p=0.01, p=0.02, respectively). The intragroup comparisons showed significant differences in SI in respect of step length (p=0.004), swing (p=0.006), stance (p=0.008) and velocity (p=0.001), cadence (p=0.001), TUG (p=0.001), kinesiophobia (p=0.001) and pain (p=0.001) in the overground group. Statistically significant differences were determined in step length (p=0.01), swing (p=0.01), stance (p=0.02) and velocity (p=0.001), cadence (p=0.001), TUG (p=0.001), kinesiophobia (p=0.001) and pain (p=0.001) in the treadmill group, when pre and post-training values were compared.
CONCLUSIONS


The results of this study have shown that treadmill gait training was more effective in the improvement of functional mobility and reduction in kinesiophobia levels of patients with LLBI compared to overground gait training. Both overground and treadmill gait training also provide greater improvements in the velocity and cadence, and gait symmetry for step length, swing and stance in patients with LLBI.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03217526.",2022,"Statistically significant differences were determined in step length (p=0.01), swing (p=0.01), stance (p=0.02) and velocity (p=0.001), cadence (p=0.001), TUG (p=0.001), kinesiophobia (p=0.001) and pain (p=0.001) in the treadmill group, when pre and post-training values were compared.
","['January 2017 and August 2018', 'patients with a lower limb burn injury (LLBI', 'patients with lower limb burn injury', 'Patients with LLBI (n=28', 'patients with LLBI']","['treadmill gait training', 'gait training modes', 'overground gait training in addition to standard burn rehabilitation, and Group 2 (treadmill group: n=14) received treadmill gait training in addition to standard burn rehabilitation', 'rehabilitation program and gait training', 'Treadmill versus overground gait training']","['Gait impairment', 'stance (p=0.02) and velocity', 'Gait symmetry', 'Gait parameters, functional mobility, kinesiophobia and pain values', 'velocity', 'velocity and cadence, and gait symmetry for step length, swing and stance', 'step length', 'kinesiophobia and TUG values', 'pain', 'timed up-and-go test (TUG), Tampa Kinesiophobia Scale and Visual Analogue Scale', 'TUG', 'gait training intensity, including walking speed and duration', 'kinesiophobia levels', 'kinesiophobia', 'SI in respect of step length', 'gait symmetry, functional mobility and kinesiophobia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0679133', 'cui_str': 'Respect'}]",,0.0117758,"Statistically significant differences were determined in step length (p=0.01), swing (p=0.01), stance (p=0.02) and velocity (p=0.001), cadence (p=0.001), TUG (p=0.001), kinesiophobia (p=0.001) and pain (p=0.001) in the treadmill group, when pre and post-training values were compared.
","[{'ForeName': 'Özden', 'Initials': 'Ö', 'LastName': 'Özkal', 'Affiliation': 'Bursa Uludağ University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Bursa, Turkey. Electronic address: ozdenozkal@gmail.com.'}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Kısmet', 'Affiliation': 'Selçuk University, Faculty of Nursing, Konya, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Konan', 'Affiliation': 'Hacettepe University School of Medicine, Department of General Surgery, Clinic of Burn, Ankara, Turkey.'}, {'ForeName': 'Mutlu', 'Initials': 'M', 'LastName': 'Hayran', 'Affiliation': 'Hacettepe University Cancer Institute, Department of Preventive Oncology, Ankara, Turkey.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Topuz', 'Affiliation': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Ankara, Turkey.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2021.04.019']
547,34156898,"Open-Label Phase II Prospective, Randomized, Controlled Study of Romyelocel-L Myeloid Progenitor Cells to Reduce Infection During Induction Chemotherapy for Acute Myeloid Leukemia.","PURPOSE


Standard cytotoxic induction chemotherapy for acute myeloid leukemia (AML) results in prolonged neutropenia and risk of infection. Romyelocel-L is a universal, allogeneic myeloid progenitor cell product being studied to reduce infection during induction chemotherapy.
PATIENTS AND METHODS


One hundred sixty-three patients with de novo AML (age ≥ 55 years) receiving induction chemotherapy were randomly assigned on day 0 (d0), of whom 120 were evaluable. Subjects received either romyelocel-L infusion on d9 with granulocyte colony-stimulating factor (G-CSF) starting daily d14 (treatment group) or G-CSF daily alone on d14 (control) until absolute neutrophil count recovery to 500/µL. End points included days in febrile episode, microbiologically defined infections, clinically diagnosed infection, and days in hospital.
RESULTS


Mean days in febrile episode was shorter in the treatment arm from d15 through d28 (2.36  v  3.90;  P  = .02). Similarly, a trend toward decreased microbiologically defined infections and clinically diagnosed infection in the treatment arm was observed from d9 to d28 (35.6%  v  47.5%;  P  = .09), reaching a statistically significant difference from d15 to d28 (6.8%  v  27.9%;  P  = .002). Because of this, antibacterial or antifungal use for treatment of an infection was significantly less in the treatment group (d9-d28: 44.1%  v  63.9%;  P  = .01). Significantly fewer patients in the treatment arm received empiric antifungals from d9 tod28 (42.4%  v  63.9%;  P  = .02) and d15-d28 (42.4%  v  62.3%;  P  = .02). Patients in the treatment arm also had 3.2 fewer hospital days compared with control (25.5  v  28.7;  P  = .001). Remission rates and days to absolute neutrophil count recovery were similar in the two groups. No patients in the romyelocel-L plus G-CSF group died because of infection compared with two patients in the control arm. No graft-versus-host disease was observed.
CONCLUSION


Subjects receiving romyelocel-L showed a decreased incidence of infections, antimicrobial use, and hospitalization, suggesting that romyelocel-L may provide a new option to reduce infections in patients with AML undergoing induction therapy.",2021,Mean days in febrile episode was shorter in the treatment arm from d15 through d28 (2.36  v  3.90;  P  = .02).,"['Acute Myeloid Leukemia', 'One hundred sixty-three patients with de novo AML (age ≥ 55 years) receiving induction chemotherapy were randomly assigned on day 0 (d0), of whom 120 were evaluable', 'patients with AML undergoing induction therapy', 'acute myeloid leukemia (AML']","['cytotoxic induction chemotherapy', 'romyelocel-L infusion on d9 with granulocyte colony-stimulating factor (G-CSF) starting daily d14 (treatment group) or G-CSF daily alone', 'Romyelocel-L Myeloid Progenitor Cells']","['Mean days in febrile episode', 'incidence of infections, antimicrobial use, and hospitalization', 'hospital days', 'microbiologically defined infections and clinically diagnosed infection', 'Infection', 'Remission rates and days to absolute neutrophil count recovery']","[{'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0596993', 'cui_str': 'Stem Cells, Myeloid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}]",163.0,0.0223794,Mean days in febrile episode was shorter in the treatment arm from d15 through d28 (2.36  v  3.90;  P  = .02).,"[{'ForeName': 'Pinkal M', 'Initials': 'PM', 'LastName': 'Desai', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Stanford University Medical Center, Stanford, CA.'}, {'ForeName': 'Saar', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Melham M', 'Initials': 'MM', 'LastName': 'Solh', 'Affiliation': 'Northside Hospital, Atlanta, GA.'}, {'ForeName': 'Luke P', 'Initials': 'LP', 'LastName': 'Akard', 'Affiliation': 'Indiana Blood and Marrow Transplantation, Indianapolis, IN.'}, {'ForeName': 'Jack W', 'Initials': 'JW', 'LastName': 'Hsu', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Celalettin', 'Initials': 'C', 'LastName': 'Ustun', 'Affiliation': 'University of Minnesota, St Paul, MN.'}, {'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Andreadis', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Frankfurt', 'Affiliation': 'Northwestern University, Chicago, IL.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Foran', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lister', 'Affiliation': 'Allegheny Health Network, Pittsburgh, PA.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Schiller', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Wieduwilt', 'Affiliation': 'Stephenson Cancer Center, University of Oklahoma, Oklahoma City, OK.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Pagel', 'Affiliation': 'Swedish Cancer Institute, Seattle, WA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Stiff', 'Affiliation': 'Loyola University Stritch School of Medicine, Maywood, IL.'}, {'ForeName': 'Delong', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'New York Medical College, Hawthorne, NY.'}, {'ForeName': 'Irum', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'University of Illinois Cancer Center, Chicago, IL.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stock', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Kambhampati', 'Affiliation': 'Kansas City Veterans Affairs Medical Center, Kansas City, MO.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': 'Northside Hospital, Atlanta, GA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Edwards', 'Affiliation': 'Indiana Blood and Marrow Transplantation, Indianapolis, IN.'}, {'ForeName': 'Iskra', 'Initials': 'I', 'LastName': 'Pusic', 'Affiliation': 'Washington University, St Louis, MO.'}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Mamelok', 'Affiliation': 'Cellerant Therapeutics, San Carlos, CA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Cellerant Therapeutics, San Carlos, CA.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Van Syoc', 'Affiliation': 'Cellerant Therapeutics, San Carlos, CA.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Kellerman', 'Affiliation': 'Cellerant Therapeutics, San Carlos, CA.'}, {'ForeName': 'Swapna', 'Initials': 'S', 'LastName': 'Panuganti', 'Affiliation': 'Cellerant Therapeutics, San Carlos, CA.'}, {'ForeName': 'Ramkumar', 'Initials': 'R', 'LastName': 'Mandalam', 'Affiliation': 'Cellerant Therapeutics, San Carlos, CA.'}, {'ForeName': 'Camille N', 'Initials': 'CN', 'LastName': 'Abboud', 'Affiliation': 'Washington University, St Louis, MO.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ravandi', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01739']
548,34161807,Self-care Management Intervention in Heart Failure (SMART-HF): A Multicenter Randomized Controlled Trial.,"BACKGROUND


Self-care behavior is important in avoiding hospitalization for patients with heart failure (HF) and refers to those activities performed with the intention of improving or restoring health and well-being, as well as treating or preventing disease. The purpose was to study the effects of a home-based mobile device on self-care behavior and hospitalizations in a representative HF-population.
METHODS AND RESULTS


SMART-HF is a randomized controlled multicenter clinical trial, where patients were randomized 1:1 to receive standard care (control group [CG]) or intervention with a home-based tool designed to enhance self-care behavior (intervention group [IG]) and followed for 240 days. The tool educates the patient about HF, monitors objective and subjective symptoms and adjusts loop diuretics. The primary outcome is self-care as measured by the European Heart Failure Self-care behavior scale and the secondary outcome is HF related in-hospital days.A total of 124 patients were recruited and 118 were included in the analyses (CG: n = 60, IG: n = 58). The mean age was 79 years, 39% were female, and 45% had an ejection fraction of less than 40%. Self-care was significantly improved in the IG compared to the CG (median (interquartile range) (21.5 [13.25; 28] vs 26 [18; 29.75], p = 0.014). Patients in the IG spent significantly less time in the hospital admitted for HF (2.2 days less, relative risk 0.48, 95% confidence interval 0.32-0.74, P = .001).
CONCLUSIONS


The device significantly improved self-care behavior and reduced in-hospital days in a relevant HF population.",2022,"Self-care was significantly improved in the IG compared to the CG (21.5 [13.25; 28] vs 26 [18; 29.75], p = 0.014).","['patients with heart failure (HF', 'A total of 124 patients were recruited and 118 were included in the analyses (CG: n\u202f=\u202f60, IG: n\u202f=\u202f58', 'The mean age was 79 years, 39% were female, and 45% had an EF < 40']","['Selfcare Management Intervention', 'home-based mobile device', 'standard care (control group, CG) or intervention with a home-based tool designed to enhance self-care behaviour (intervention group, IG']","['self-care as measured by the European Heart Failure Self-care behaviour scale and the secondary outcome is HF related in-hospital days', 'Self-care', 'self-care behaviour', 'hospital admitted for HF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",124.0,0.141273,"Self-care was significantly improved in the IG compared to the CG (21.5 [13.25; 28] vs 26 [18; 29.75], p = 0.014).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sahlin', 'Affiliation': 'Department of Emergency and Internal Medicine, Skåne University Hospital, Skåne, Sweden.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Rezanezad', 'Affiliation': 'Department of Emergency and Internal Medicine, Skåne University Hospital, Skåne, Sweden; Department of Clinical Sciences, Lund University, Malmö, Sweden.'}, {'ForeName': 'Marie-Louise', 'Initials': 'ML', 'LastName': 'Edvinsson', 'Affiliation': 'Department of Emergency and Internal Medicine, Skåne University Hospital, Skåne, Sweden; Department of Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Erasums', 'Initials': 'E', 'LastName': 'Bachus', 'Affiliation': 'Department of Clinical Sciences, Lund University, Malmö, Sweden.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Melander', 'Affiliation': 'Department of Emergency and Internal Medicine, Skåne University Hospital, Skåne, Sweden; Department of Clinical Sciences, Lund University, Malmö, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Gerward', 'Affiliation': 'Department of Clinical Sciences, Lund University, Malmö, Sweden. Electronic address: sofia.gerward@med.lu.se.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2021.06.009']
549,34161750,Impact of Lens Material on Objective Refraction in Eyes with Trifocal Diffractive Intraocular Lenses.,"PURPOSE


Compare subjective (Rx) and objective (ObjRx) refractions outcomes with two autorefractors models and an aberrometer in eyes implanted with a hydrophobic trifocal IOL (FineVision POD F GF, Physiol, Liége, Belgium) and a hydrophilic one (FineVision POD F, Physiol, Liége, Belgium).
METHODS


Prospective comparative cohort study, with 100 subjects randomly assigned to either the POD F group (n = 50) or the POD F-GF group (n = 50). Postoperative eye examinations at 1-month visit included seven result sets, one for each assessment method: Rx, AR (automated refraction measured with the autorefractor KR8800), WF-P (Zernike-coefficients-based objective refraction, photopic pupil size), WF-M (Zernike-coefficients-based objective refraction, mesopic pupil size), WF-4 (Zernike-coefficients-based objective refraction, 4 mm pupil), OPD-C (automated refraction measured with the aberrometer OPD in the central pupil/photopic conditions), and OPD-M (automated refraction measured with the aberrometer OPD under mesopic conditions).
RESULTS


Mean differences between ObjRx and Rx reached statistical significance for sphere and spherical equivalent (M) only with OPD-C in the POD F-GF group. All ObjRx methods showed significant differences with Rx in the POD F group, with some values differing by more than 0.50 D (-0.58 D in M for the WF-P). Bland Altman plots showed better agreement for the astigmatic components, and for sphere and spherical equivalents in both IOL groups measured with AR and OPD-M.
CONCLUSIONS


None of the objective methods of refraction evaluated in this study were as reliable as the subjective refraction, irrespective of the lens material, but POD F-GF ObjRx seems to differ less with Rx than POD F ObjRx values.",2022,"RESULTS


Mean differences between ObjRx and Rx reached statistical significance for sphere and spherical equivalent (M) only with OPD-C in the POD F-GF group.",['100 subjects randomly assigned to either the'],"['POD F-GF', 'POD F']","['Rx, AR (automated refraction measured with the autorefractor KR8800), WF-P (Zernike-coefficients-based objective refraction, photopic pupil size), WF-M (Zernike-coefficients-based objective refraction, mesopic pupil size), WF-4 (Zernike-coefficients-based objective refraction, 4 mm pupil), OPD-C (automated refraction measured with the aberrometer OPD in the central pupil/photopic conditions), and OPD-M (automated refraction', 'subjective (Rx) and objective']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]",[],"[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1275634', 'cui_str': 'Automated infrared optometer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1301317', 'cui_str': 'Objective refraction'}, {'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1532954', 'cui_str': 'Wavefront analyzer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",100.0,0.0479611,"RESULTS


Mean differences between ObjRx and Rx reached statistical significance for sphere and spherical equivalent (M) only with OPD-C in the POD F-GF group.","[{'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Garzón', 'Affiliation': 'Miranza Group, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Poyales', 'Affiliation': 'Miranza Group, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'García-Montero', 'Affiliation': 'Miranza Group, Madrid, Spain.'}, {'ForeName': 'Fidel', 'Initials': 'F', 'LastName': 'Vega', 'Affiliation': ""Departament d'Òptica i Optometria, Universitat Politécnica de Catalunya, BarcelonaTech, Terrassa, Spain.""}, {'ForeName': 'María Sagrario', 'Initials': 'MS', 'LastName': 'Millán', 'Affiliation': ""Departament d'Òptica i Optometria, Universitat Politécnica de Catalunya, BarcelonaTech, Terrassa, Spain.""}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Albarrán-Diego', 'Affiliation': 'Optics, Optometry and Vision Science Department, Faculty of Physics, University of Valencia, Burjassot, Spain.'}]",Current eye research,['10.1080/02713683.2021.1946563']
550,34161745,Body mass-normalized moderate dose of dietary nitrate intake improves endothelial function and walking capacity in patients with peripheral artery disease.,"Peripheral artery disease (PAD) is characterized by the accumulation of atherosclerotic plaques in the lower extremity conduit arteries, which impairs blood flow and walking capacity. Dietary nitrate has been used to reduce blood pressure (BP) and improve walking capacity in PAD. However, a standardized dose for PAD has not been determined. Therefore, we sought to determine the effects of a body mass-normalized moderate dose of nitrate (0.11 mmol nitrate/kg) as beetroot juice on serum nitrate/nitrite, vascular function, walking capacity, and tissue oxygen utilization capacity in patients with PAD. A total of 11 patients with PAD received either nitrate supplement or placebo in a randomized crossover design. Total serum nitrate/nitrite, resting BP, brachial and popliteal artery endothelial function (flow-mediated dilation, FMD), arterial stiffness (pulse-wave velocity, PWV), augmentation index (AIx), maximal walking distance and time, claudication onset time, and skeletal muscle oxygen utilization were measured pre- and postnitrate and placebo intake. There were significant group × time interactions ( P  < 0.05) for serum nitrate/nitrite, FMD, BP, walking distance and time, and skeletal muscle oxygen utilization. The nitrate group showed significantly increased serum nitrate/nitrite (Δ1.32 μM), increased brachial and popliteal FMD (Δ1.3% and Δ1.7%, respectively), reduced peripheral and central systolic BP (Δ-4.7 mmHg and Δ-8.2 mmHg, respectively), increased maximal walking distance (Δ92.7 m) and time (Δ56.3 s), and reduced deoxygenated hemoglobin during walking. There were no changes in PWV, AIx, or claudication ( P  > 0.05). These results indicate that a body-mass normalized moderate dose of nitrate may be effective and safe for reducing BP, improving endothelial function, and improving walking capacity in patients with PAD.",2021,"The nitrate group showed significantly increased serum nitrate/nitrite (Δ1.32μM), increased brachial and popliteal FMD (Δ1.3% and Δ1.7%, respectively), reduced peripheral and central systolic BP (Δ-4.7mmHg and Δ-8.2mmHg, respectively), increased maximal walking distance (Δ92.7m) and time (Δ56.3s), and reduced deoxygenated hemoglobin during walking.","['11 patients with PAD', 'patients with peripheral artery disease', 'patients with PAD']","['dietary nitrate intake', 'nitrate supplement or placebo']","['serum nitrate/nitrite, vascular function, walking capacity, and tissue oxygen utilization capacity', 'PWV, AIx, or claudication (p>0.05', 'walking capacity', 'maximal walking distance (Δ92.7m) and time (Δ56.3s), and reduced deoxygenated hemoglobin', 'Total serum nitrate/nitrite, resting BP, brachial and popliteal artery endothelial function (flow-mediated dilation, FMD), arterial stiffness (pulse-wave velocity, PWV), augmentation index (AIx), maximal walking distance and time, claudication onset time, and skeletal muscle oxygen utilization', 'serum nitrate/nitrite, FMD, BP, walking distance and time, and skeletal muscle oxygen utilization', 'serum nitrate/nitrite (Δ1.32μM), increased brachial and popliteal FMD', 'BP, improving endothelial function', 'endothelial function and walking capacity', 'reduced peripheral and central systolic BP', 'blood pressure (BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0057437', 'cui_str': 'Deoxyhemoglobin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",11.0,0.0175328,"The nitrate group showed significantly increased serum nitrate/nitrite (Δ1.32μM), increased brachial and popliteal FMD (Δ1.3% and Δ1.7%, respectively), reduced peripheral and central systolic BP (Δ-4.7mmHg and Δ-8.2mmHg, respectively), increased maximal walking distance (Δ92.7m) and time (Δ56.3s), and reduced deoxygenated hemoglobin during walking.","[{'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Pekas', 'Affiliation': 'School of Health & Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'TeSean K', 'Initials': 'TK', 'LastName': 'Wooden', 'Affiliation': 'School of Health & Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Santosh K', 'Initials': 'SK', 'LastName': 'Yadav', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'School of Health & Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00121.2021']
551,33676366,The carbon isotope ratios of nonessential amino acids identify sugar-sweetened beverage (SSB) consumers in a 12-wk inpatient feeding study of 32 men with varying SSB and meat exposures.,"BACKGROUND


The carbon isotope ratios (CIRs) of individual amino acids (AAs) may provide more sensitive and specific biomarkers of sugar-sweetened beverages (SSBs) than total tissue CIR. Because CIRs turn over slowly, long-term controlled-feeding studies are needed in their evaluation.
OBJECTIVE


We assessed the responses of plasma and RBC CIRAA's to SSB and meat intake in a 12-wk inpatient feeding study.
METHODS


Thirty-two men (aged 46.2 ± 10.5 y) completed the feeding study at the National Institute of Diabetes and Digestive and Kidney Diseases in Phoenix, Arizona. The effects of SSB, meat, and fish intake on plasma and RBC CIRAA's were evaluated in a balanced factorial design with each dietary variable either present or absent in a common weight-maintaining, macronutrient-balanced diet. Fasting blood samples were collected biweekly from baseline. Dietary effects on the postfeeding CIR of 5 nonessential AAs (CIRNEAA's) and 4 essential AAs (CIREAA's) were analyzed using multivariable regression.
RESULTS


In plasma, 4 of 5 CIRNEAA's increased with SSB intake. Of these, the CIRAla was the most sensitive (β = 2.81, SE = 0.38) to SSB intake and was not affected by meat or fish intake. In RBCs, all 5 CIRNEAA's increased with SSBs but had smaller effect sizes than in plasma. All plasma CIREAA's increased with meat intake (but not SSB or fish intake), and the CIRLeu was the most sensitive (β = 1.26, SE = 0.23). CIRs of leucine and valine also increased with meat intake in RBCs. Estimates of turnover suggest that CIRAA's in plasma, but not RBCs, were in equilibrium with the diets by the end of the study.
CONCLUSIONS


The results of this study in men support CIRNEAA's as potential biomarkers of SSB intake and suggest CIREAA's as potential biomarkers of meat intake in US diets. This trial was registered at clinicaltrials.gov/ct2/show/NCT01237093 as NCT01237093.",2021,"Of these, the CIRAla was the most sensitive (β = 2.81, SE = 0.38) to SSB intake and was not affected by meat or fish intake.","['32 men with varying SSB and meat exposures', 'Thirty-two men (aged 46.2\xa0±\xa010.5 y) completed the feeding study at the National Institute of Diabetes and Digestive and Kidney Diseases in Phoenix, Arizona']",[],"['SSB intake', 'Fasting blood samples', ""responses of plasma and RBC CIRAA's to SSB and meat intake"", ""SSB, meat, and fish intake on plasma and RBC CIRAA's""]","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1513898', 'cui_str': 'NIDDK'}, {'cui': 'C0003787', 'cui_str': 'Arizona - US state'}]",[],"[{'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0556201', 'cui_str': 'Meat intake'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0556216', 'cui_str': 'Fish intake'}]",32.0,0.0555722,"Of these, the CIRAla was the most sensitive (β = 2.81, SE = 0.38) to SSB intake and was not affected by meat or fish intake.","[{'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Johnson', 'Affiliation': 'Institute of Arctic Biology, Department of Biology and Wildlife, University of Alaska Fairbanks, Fairbanks, AK, USA.'}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Shaw', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Oh', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Wooller', 'Affiliation': 'Alaska Stable Isotope Facility, Water and Environmental Research Center, Institute of Northern Engineering, University of Alaska Fairbanks, Fairbanks, AK, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Merriman', 'Affiliation': 'Institute of Arctic Biology, Department of Biology and Wildlife, University of Alaska Fairbanks, Fairbanks, AK, USA.'}, {'ForeName': 'Hee Young', 'Initials': 'HY', 'LastName': 'Yun', 'Affiliation': 'Institute of Arctic Biology, Department of Biology and Wildlife, University of Alaska Fairbanks, Fairbanks, AK, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Larsen', 'Affiliation': 'Department of Archaeology, Max Planck Institute for the Science of Human History, Jena, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Krakoff', 'Affiliation': 'Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases/NIH, Phoenix, AZ, USA.'}, {'ForeName': 'Susanne B', 'Initials': 'SB', 'LastName': 'Votruba', 'Affiliation': 'Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases/NIH, Phoenix, AZ, USA.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': ""O'Brien"", 'Affiliation': 'Institute of Arctic Biology, Department of Biology and Wildlife, University of Alaska Fairbanks, Fairbanks, AK, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa374']
552,34153006,Intrathecal 2-Chloroprocaine 3% Versus Hyperbaric Bupivacaine 0.75% for Cervical Cerclage: A Double-Blind Randomized Controlled Trial.,"BACKGROUND


Cervical cerclage is a short ambulatory procedure. For spinal anesthesia, local anesthetic agents with rapid postoperative resolution are desired. We hypothesized that in combination with fentanyl, intrathecal 2-chloroprocaine would produce earlier resolution of motor block, resulting in shorter time to meet recovery room discharge criteria than hyperbaric bupivacaine.
METHODS


Women undergoing cervical cerclage with spinal anesthesia were randomized to receive intrathecal 2-chloroprocaine 3% 50 mg or hyperbaric bupivacaine 0.75% 9 mg, both with fentanyl 15 µg. Doses were empirically selected. The onset and resolution of sensory and motor blockade and time to achieve recovery room discharge criteria were monitored. On postoperative day 1, patients rated their satisfaction with the anesthetic and reported on transient neurologic symptoms (TNS), back pain, or headache. The primary outcome was time from spinal injection to motor block resolution. The main secondary outcomes included times from spinal injection to (i) T12 dermatomal level, (ii) sensory block resolution, and (iii) ability to ambulate and void.
RESULTS


Forty-three women were enrolled and randomized to either the chloroprocaine (N = 23) or bupivacaine group (N = 20). The mean (standard deviation [SD]) duration of surgery was 35.3 (11.4) minutes. There was no difference between groups for time to motor block resolution-the median [interquartile range] time for the bupivacaine group (N = 17) was 112 [97-143] minutes versus 109 [88-148] minutes in the chloroprocaine group (N = 22), P = .66, but there was a significant difference in median time to sensory block resolution: 143 [116-162] minutes in the chloroprocaine group versus 198 [152-263] minutes in the bupivacaine group, P = .002. The recovery room discharge criteria, which at our institution include the ability to ambulate unassisted and void urine, were met 76 (95% CI, 33-145) minutes earlier in the chloroprocaine group, P < .0005. One complete block failure occurred with hyperbaric bupivacaine and 2 subjects in each group received treatment for intraoperative discomfort. No patients reported TNS.
CONCLUSIONS


Intrathecal 2-chloropocaine 3% provided similarly effective surgical anesthesia for cerclage placement. Although no difference in time to motor block resolution between groups was observed, the time to sensory block resolution and time to meet recovery room discharge criteria were both significantly shorter among patients who received chloroprocaine than patients who received bupivacaine. Future studies are needed to identify and compare equipotent doses of chloroprocaine and bupivacaine to confirm the superiority of chloroprocaine for this ambulatory obstetric procedure.",2022,"Although no difference in time to motor block resolution between groups was observed, the time to sensory block resolution and time to meet recovery room discharge criteria were both significantly shorter among patients who received chloroprocaine than patients who received bupivacaine.","['Forty-three women', 'Women undergoing cervical cerclage with spinal anesthesia', 'Cervical Cerclage']","['intrathecal 2-chloroprocaine 3% 50 mg or hyperbaric bupivacaine', 'chloroprocaine', 'Intrathecal 2-Chloroprocaine', 'Intrathecal 2-chloropocaine', 'fentanyl, intrathecal 2-chloroprocaine', 'Hyperbaric Bupivacaine', 'bupivacaine', 'hyperbaric bupivacaine']","['transient neurologic symptoms (TNS), back pain, or headache', 'mean (standard deviation [SD]) duration of surgery', 'times from spinal injection to (i) T12 dermatomal level, (ii) sensory block resolution, and (iii) ability to ambulate and void', 'time to motor block resolution-the median [interquartile range] time', 'block failure', 'median time to sensory block resolution', 'time from spinal injection to motor block resolution', 'time to motor block resolution', 'recovery room discharge criteria', 'time to sensory block resolution and time to meet recovery room discharge criteria']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0195681', 'cui_str': 'Cerclage of uterine cervix'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0055443', 'cui_str': 'chloroprocaine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0235031', 'cui_str': 'Neurological symptom'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021498', 'cui_str': 'Spinal Injections'}, {'cui': 'C0054967', 'cui_str': 'Lymphocyte antigen CD6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}]",43.0,0.444183,"Although no difference in time to motor block resolution between groups was observed, the time to sensory block resolution and time to meet recovery room discharge criteria were both significantly shorter among patients who received chloroprocaine than patients who received bupivacaine.","[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'From the Department of Anesthesiology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Shatil', 'Affiliation': 'Department of Anesthesiology, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Landau', 'Affiliation': 'From the Department of Anesthesiology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Prahlad', 'Initials': 'P', 'LastName': 'Menon', 'Affiliation': 'Department of Bioengineering, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Smiley', 'Affiliation': 'From the Department of Anesthesiology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005653']
553,34154963,[Medico-economic evaluation of the impact of measures to adapt to the switch to surgery robot-assisted in urology].,"INTRODUCTION


The development of robot-assisted urological surgery is held back by the lack of robust medico-economic analyses and their heterogeneity. We conducted a medico-economic study to evaluate the implementation of measures to optimize the transition to robotic surgery.
METHOD


We carried out a single-center, controlled study from the point of view of the public healthcare establishment for 4 years. Economic data collection was based on a micro-costing method and revenues from stay-related groups. Clinical data corresponded to mean lengths of stay, operating duration, complications and stays in intensive care. The measures to optimize the transition to robotic, implemented mid-study period, enabled before/after comparison.
RESULTS


Altogether, 668 patients undergoing robotic surgery were included. Robotic activity increased significantly from periods 1 to 2 to 256% (P=<0.001) as did the overall proportion of robotic by 45% to 85% (P=<0.001). The mean lengths of stay fell significantly, 6.8 d vs. 5.1 d (P<0.001). Costs and revenues increased significantly, resulting in a persistent deficit for the activity €226K vs. €382K (P=<0.001). With increased volume of activity, the deficit per operation and the cost per minute of robotic operating room fell significantly, €3,284 vs. €1,474/procedure (P=<0.001) and €27 vs €24/min (P=<0.029), tending towards a break-even point (=zero deficit) at 430 operations per year.
CONCLUSIONS


Robotic-assisted surgery can be significantly optimized by implementing measures for the robotic turn to reach a break-even point at 430 operations per year. A better multidisciplinary case mix could lower the break-even volume of activity in short term.
LEVEL OF EVIDENCE


3.",2022,Robotic activity increased significantly from periods 1 to 2 to 256% (P=<0.001) as did the overall proportion of robotic by 45% to 85% (P=<0.001).,['668 patients undergoing robotic surgery were included'],"['robot-assisted urological surgery', 'Robotic-assisted surgery']","['overall proportion of robotic', 'mean lengths of stay fell', 'mean lengths of stay, operating duration, complications and stays in intensive care', 'Robotic activity', 'volume of activity, the deficit per operation and the cost per minute of robotic operating room fell']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",668.0,0.0470237,Robotic activity increased significantly from periods 1 to 2 to 256% (P=<0.001) as did the overall proportion of robotic by 45% to 85% (P=<0.001).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Durand', 'Affiliation': ""Service d'Urologie, Andrologie, Transplantation Rénale, Hôpital Pasteur 2, CHU de Nice; Inserm U1081 - CNRS UMR 7284 Université de Nice Côte d'Azur. Electronic address: durand.m@chu-nice.fr.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bentellis', 'Affiliation': ""Service d'Urologie, Andrologie, Transplantation Rénale, Hôpital Pasteur 2, CHU de Nice.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shaikh', 'Affiliation': ""Service d'Urologie, Andrologie, Transplantation Rénale, Hôpital Pasteur 2, CHU de Nice.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Barthe', 'Affiliation': ""Service d'Urologie, Andrologie, Transplantation Rénale, Hôpital Pasteur 2, CHU de Nice.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Imbert de la Phalecque', 'Affiliation': ""Service d'Urologie, Andrologie, Transplantation Rénale, Hôpital Pasteur 2, CHU de Nice.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Tibi', 'Affiliation': ""Service d'Urologie, Andrologie, Transplantation Rénale, Hôpital Pasteur 2, CHU de Nice.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ahallal', 'Affiliation': ""Service d'Urologie, Andrologie, Transplantation Rénale, Hôpital Pasteur 2, CHU de Nice.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Elleboode', 'Affiliation': 'Direction Générale, ARS Nouvelle-Aquitaine.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Guepratte', 'Affiliation': 'Direction Générale, CHU de Nice.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Acloque', 'Affiliation': 'Service de contrôle de Gestion, CHU de Nice.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lechevallier', 'Affiliation': ""Service d'Urologie et Transplantation Rénale, Hôpital de la Conception, APHM - Aix-Marseille Université - Campus Timone - Faculté des Sciences Médicales et Paramédicales, boulevard J Moulin, 13385 Marseille.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Chevallier', 'Affiliation': ""Service d'Urologie, Andrologie, Transplantation Rénale, Hôpital Pasteur 2, CHU de Nice.""}]",Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie,['10.1016/j.purol.2020.12.019']
554,34157132,Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis: interim analysis of the LIMMitless open-label extension trial beyond 3 years of follow-up.,"BACKGROUND


Psoriasis is a chronic inflammatory skin disease requiring prolonged treatment. New biologic therapies require long-term evaluation to assess the durability of their efficacy and safety profiles over time.
OBJECTIVES


To evaluate the long-term efficacy and safety of risankizumab (RZB) for the treatment of psoriasis.
METHODS


LIMMitless is an ongoing, phase III, open-label extension study evaluating the long-term efficacy and safety of RZB in adults with moderate-to-severe plaque psoriasis following multiple phase II/III studies. This analysis assessed efficacy through 172 weeks of continuous RZB treatment by examining the proportion of patients achieving ≥ 90% or 100% improvement in Psoriasis Area and Severity Index (PASI 90 and PASI 100), static Physician's Global Assessment of clear or almost clear (sPGA 0/1) and Dermatology Life Quality Index of no effect on quality of life (DLQI 0/1). Safety was assessed by recording adverse events (AEs) through the data cutoff date. The study is registered at ClinicalTrials.gov (identifier: NCT03047395).
RESULTS


Of 955 patients randomized to RZB 150 mg in the base studies, 897 patients continued into LIMMitless; 799 patients were still receiving treatment in LIMMitless at the time of data cutoff for this analysis. After 172 weeks of continuous RZB treatment, 85·5% of patients achieved PASI 90, 54·4% achieved PASI 100, 85·2% achieved sPGA 0/1, and 78·4% achieved DLQI 0/1 using modified nonresponder imputation. Rates of AEs leading to discontinuation and AEs of safety interest were low with long-term treatment and comparable with those identified in the base studies.
CONCLUSIONS


Overall, long-term continuous RZB was well tolerated and showed high and durable efficacy over 172 weeks.",2021,"Rates of AEs leading to discontinuation and AEs of safety interest were low with long-term treatment and comparable to those identified in the base studies.
","['955 patients randomized to RZB\xa0150', '897\xa0patients continued into LIMMitless; 799 patients', 'psoriasis', 'adults with moderate-to-severe plaque psoriasis following multiple phase\xa02/3 studies', 'moderate-to-severe plaque psoriasis']","['risankizumab', 'risankizumab (RZB', 'RZB']","['tolerated and showed high and durable efficacy', ""Psoriasis Area and Severity Index (PASI\xa090 and PASI\xa0100), static Physician's Global Assessment of clear or almost clear (sPGA\xa00/1), and Dermatology Life Quality Index of no effect on quality of life (DLQI 0/1"", 'Rates of AEs leading to discontinuation and AEs of safety interest']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4505511', 'cui_str': 'risankizumab'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C1301751', 'cui_str': 'No effect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",955.0,0.0324468,"Rates of AEs leading to discontinuation and AEs of safety interest were low with long-term treatment and comparable to those identified in the base studies.
","[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Puig', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ohtsuki', 'Affiliation': 'Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Beissert', 'Affiliation': 'Department of Dermatology, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rubant', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sinvhal', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Soliman', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Alperovich', 'Affiliation': 'AbbVie Inc., Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Leonardi', 'Affiliation': 'Central Dermatology, Richmond Heights, MO, USA.'}]",The British journal of dermatology,['10.1111/bjd.20595']
555,34159342,"Molnupiravir, an Oral Antiviral Treatment for COVID-19.","Background


Easily distributed oral antivirals are urgently needed to treat coronavirus disease-2019 (COVID-19), prevent progression to severe illness, and block transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We report the results of a Phase 2a trial evaluating the safety, tolerability, and antiviral efficacy of molnupiravir in the treatment of COVID-19 ( ClinicalTrials.gov NCT04405570 ).
Methods


Eligible participants included outpatients with confirmed SARS-CoV-2 infection and symptom onset within 7 days. Participants were randomized 1:1 to 200 mg molnupiravir or placebo, or 3:1 to molnupiravir (400 or 800 mg) or placebo, twice-daily for 5 days. Antiviral activity was assessed as time to undetectable levels of viral RNA by reverse transcriptase polymerase chain reaction and time to elimination of infectious virus isolation from nasopharyngeal swabs.
Results


Among 202 treated participants, virus isolation was significantly lower in participants receiving 800 mg molnupiravir (1.9%) versus placebo (16.7%) at Day 3 (p = 0.02). At Day 5, virus was not isolated from any participants receiving 400 or 800 mg molnupiravir, versus 11.1% of those receiving placebo (p = 0.03). Time to viral RNA clearance was decreased and a greater proportion overall achieved clearance in participants administered 800 mg molnupiravir versus placebo (p = 0.01). Molnupiravir was generally well tolerated, with similar numbers of adverse events across all groups.
Conclusions


Molnupiravir is the first oral, direct-acting antiviral shown to be highly effective at reducing nasopharyngeal SARS-CoV-2 infectious virus and viral RNA and has a favorable safety and tolerability profile.",2021,Time to viral RNA clearance was decreased and a greater proportion overall achieved clearance in participants administered 800 mg molnupiravir versus placebo (p = 0.01).,['Eligible participants included outpatients with confirmed SARS-CoV-2 infection and symptom onset within 7 days'],"['placebo', 'molnupiravir or placebo, or 3:1 to molnupiravir (400 or 800 mg) or placebo']","['Time to viral RNA clearance', 'safety, tolerability, and antiviral efficacy', 'Antiviral activity', 'virus isolation']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3844106', 'cui_str': '800'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035736', 'cui_str': 'Viral RNA'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0200955', 'cui_str': 'Viral culture'}]",202.0,0.240204,Time to viral RNA clearance was decreased and a greater proportion overall achieved clearance in participants administered 800 mg molnupiravir versus placebo (p = 0.01).,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fischer', 'Affiliation': ''}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Eron', 'Affiliation': ''}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Holman', 'Affiliation': ''}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': ''}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Szewczyk', 'Affiliation': ''}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Sheahan', 'Affiliation': ''}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Baric', 'Affiliation': ''}, {'ForeName': 'Katie R', 'Initials': 'KR', 'LastName': 'Mollan', 'Affiliation': ''}, {'ForeName': 'Cameron R', 'Initials': 'CR', 'LastName': 'Wolfe', 'Affiliation': ''}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Duke', 'Affiliation': ''}, {'ForeName': 'Masoud M', 'Initials': 'MM', 'LastName': 'Azizad', 'Affiliation': ''}, {'ForeName': 'Katyna', 'Initials': 'K', 'LastName': 'Borroto-Esoda', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wohl', 'Affiliation': ''}, {'ForeName': 'Amy James', 'Initials': 'AJ', 'LastName': 'Loftis', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Alabanza', 'Affiliation': ''}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Lipansky', 'Affiliation': ''}, {'ForeName': 'Wendy P', 'Initials': 'WP', 'LastName': 'Painter', 'Affiliation': ''}]",medRxiv : the preprint server for health sciences,['10.1101/2021.06.17.21258639']
556,34156758,"Wound healing with ""spray-on"" autologous skin grafting (ReCell) compared with standard care in patients with large diabetes-related foot wounds: an open-label randomised controlled trial.","There is an urgent need for interventions that improve healing time, prevent amputations and recurrent ulceration in patients with diabetes-related foot wounds. In this randomised, open-label trial, participants were randomised to receive an application of non-cultured autologous skin cells (""spray-on"" skin; ReCell) or standard care interventions for large (>6 cm 2  ), adequately vascularised wounds. The primary outcome was complete healing at 6 months, determined by assessors blinded to the intervention. Forty-nine eligible foot wounds in 45 participants were randomised. An evaluable primary outcome was available for all wounds. The median (interquartile range) wound area at baseline was 11.4 (8.8-17.6) cm 2  . A total of 32 (65.3%) index wounds were completely healed at 6 months, including 16 of 24 (66.7%) in the spray-on skin group and 16 of 25 (64.0%) in the standard care group (unadjusted OR [95% CI]: 1.13 (0.35-3.65), P = .845). Lower body mass index (P = .002) and non-plantar wounds (P = .009) were the only patient- or wound-related factors associated with complete healing at 6 months. Spray-on skin resulted in high rates of complete healing at 6 months in patients with large diabetes-related foot wounds, but was not significantly better than standard care (Australian New Zealand Clinical Trials Registry: ACTRN12618000511235).",2022,"Spray-on skin resulted in high rates of complete healing at 6 months in patients with large diabetes-related foot wounds, but was not significantly better than standard care (Australian New Zealand Clinical Trials Registry:","['patients with diabetes-related foot wounds', 'patients with large diabetes-related foot wounds', 'Forty-nine eligible foot wounds in 45 participants']","['spray-on"" autologous skin grafting (ReCell', 'standard care', 'application of non-cultured autologous skin cells (""spray-on"" skin; ReCell) or standard care interventions for large ']","['complete healing', 'Wound healing', 'healing time', 'Lower body mass index', 'complete healing at 6\xa0months']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0037297', 'cui_str': 'Grafting to skin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0814995', 'cui_str': 'Skin cell'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231255', 'cui_str': 'Decreased body mass index'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",45.0,0.0789437,"Spray-on skin resulted in high rates of complete healing at 6 months in patients with large diabetes-related foot wounds, but was not significantly better than standard care (Australian New Zealand Clinical Trials Registry:","[{'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Manning', 'Affiliation': 'Harry Perkins Research Institute, Fiona Stanley Hospital, Medical School, University of Western Australia, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Ivana Bastos', 'Initials': 'IB', 'LastName': 'Ferreira', 'Affiliation': 'Multidisciplinary Diabetes Foot Ulcer Service, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gittings', 'Affiliation': 'Department of Burns, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hiew', 'Affiliation': 'Multidisciplinary Diabetes Foot Ulcer Service, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Ryan', 'Affiliation': 'Multidisciplinary Diabetes Foot Ulcer Service, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Mendel', 'Initials': 'M', 'LastName': 'Baba', 'Affiliation': 'Multidisciplinary Diabetes Foot Ulcer Service, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Raby', 'Affiliation': 'Department of Infectious Diseases, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Keryln', 'Initials': 'K', 'LastName': 'Carville', 'Affiliation': 'Silver Chain Group and Curtin University, Wilson, Western Australia, Australia.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Norman', 'Affiliation': 'Harry Perkins Research Institute, Fiona Stanley Hospital, Medical School, University of Western Australia, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Wendy Angela', 'Initials': 'WA', 'LastName': 'Davis', 'Affiliation': 'Medical School, Fremantle Hospital, University of Western Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Wood', 'Affiliation': 'Department of Burns, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Emma Jane', 'Initials': 'EJ', 'LastName': 'Hamilton', 'Affiliation': 'Harry Perkins Research Institute, Fiona Stanley Hospital, Medical School, University of Western Australia, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Jens Carsten', 'Initials': 'JC', 'LastName': 'Ritter', 'Affiliation': 'Multidisciplinary Diabetes Foot Ulcer Service, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}]",International wound journal,['10.1111/iwj.13646']
557,34165694,Confirmed 6-Month Disability Improvement and Worsening Correlate with Long-term Disability Outcomes in Alemtuzumab-Treated Patients with Multiple Sclerosis: Post Hoc Analysis of the CARE-MS Studies.,"INTRODUCTION


In the 2-year CARE-MS trials (NCT00530348; NCT00548405) in patients with relapsing-remitting multiple sclerosis, alemtuzumab showed superior efficacy versus subcutaneous interferon beta-1a. Efficacy was maintained in two consecutive extensions (NCT00930553; NCT02255656). This post hoc analysis compared disability outcomes over 9 years among alemtuzumab-treated patients according to whether they experienced confirmed disability improvement (CDI) or worsening (CDW) or neither CDI nor CDW.
METHODS


CARE-MS patients were randomized to receive two alemtuzumab courses (12 mg/day; 5 days at baseline; 3 days at 12 months), with additional as-needed 3-day courses in the extensions. CDI or CDW were defined as ≥ 1.0-point decrease or increase, respectively, in Expanded Disability Status Scale (EDSS) score from core study baseline confirmed over 6 months, assessed in patients with baseline EDSS score ≥ 2.0. Improved or stable EDSS scores were defined as ≥ 1-point decrease or ≤ 0.5-point change (either direction), respectively, from core study baseline. Functional systems (FS) scores were also assessed.
RESULTS


Of 511 eligible patients, 43% experienced CDI and 34% experienced CDW at any time through year 9 (patients experiencing both CDI and CDW were counted in each individual group); 29% experienced neither CDI nor CDW. At year 9, patients with CDI had a -0.58-point mean EDSS score change from baseline; 88% had stable or improved EDSS scores. Improvements occurred across all FS, primarily in sensory, pyramidal, and cerebellar domains. Patients with CDW had a +1.71-point mean EDSS score change; 16% had stable or improved EDSS scores. Patients with neither CDI nor CDW had a -0.10-point mean EDSS score change; 98% had stable or improved EDSS scores.
CONCLUSION


CDI achievement at any point during the CARE-MS studies was associated with improved disability at year 9, highlighting the potential of alemtuzumab to change the multiple sclerosis course. Conversely, CDW at any point was associated with worsened disability at year 9.",2021,"Improvements occurred across all FS, primarily in sensory, pyramidal, and cerebellar domains.",['patients with relapsing-remitting multiple sclerosis'],[],"['6-Month Disability Improvement and Worsening Correlate with Long-term Disability Outcomes', 'worsened disability', 'disability improvement (CDI) or worsening (CDW', 'Functional systems (FS) scores', 'CDW', 'EDSS scores', 'CDI nor CDW', 'disability outcomes', 'stable EDSS scores', 'Efficacy', 'Expanded Disability Status Scale (EDSS) score', 'sensory, pyramidal, and cerebellar domains', 'CDI or CDW']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}]",[],"[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",511.0,0.0535114,"Improvements occurred across all FS, primarily in sensory, pyramidal, and cerebellar domains.","[{'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Hunter', 'Affiliation': 'Advanced Neurosciences Institute, 101 Forrest Crossing Blvd., Franklin, TN, 37064, USA. sfhunter@neurosci.us.'}, {'ForeName': 'Rany A', 'Initials': 'RA', 'LastName': 'Aburashed', 'Affiliation': 'Institute for Neurosciences and Multiple Sclerosis, Owosso, MI, USA.'}, {'ForeName': 'Raed', 'Initials': 'R', 'LastName': 'Alroughani', 'Affiliation': 'Division of Neurology, Department of Medicine, Amiri Hospital, Sharq, Kuwait.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Department of Neurology, Inselspital Bern, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Dive', 'Affiliation': 'University Hospital Centre of Liège, Liège, Belgium.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Eichau', 'Affiliation': 'Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kantor', 'Affiliation': 'Florida Atlantic University, Boca Raton, FL, USA.'}, {'ForeName': 'Ho Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Research Institute and Hospital of National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lycke', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Richard A L', 'Initials': 'RAL', 'LastName': 'Macdonell', 'Affiliation': 'Austin Health and Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Pozzilli', 'Affiliation': 'Department of Human Neuroscience, Sapienza University, Rome, Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Scott', 'Affiliation': 'Allegheny General Hospital, Drexel University College of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Sharrack', 'Affiliation': 'Sheffield NIHR Neuroscience BRC and Sheffield Teaching Hospitals, Sheffield, UK.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Wiendl', 'Affiliation': 'University of Münster, Münster, Germany.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Chung', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Daizadeh', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Darren P', 'Initials': 'DP', 'LastName': 'Baker', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vermersch', 'Affiliation': 'Univ. Lille, INSERM U1172 LilNCog, CHU Lille, FHU Precise, Lille, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology and therapy,['10.1007/s40120-021-00262-3']
558,34166810,The Role of the Observers' Perception of a Model's Self-Confidence in Observationally Induced Placebo Analgesia.,"The aim of this study was to investigate the effect of a model's self-confidence as well as the observer's self-esteem and self-efficacy on observationally acquired placebo analgesia. In addition, we aimed to verify the stability of the placebo effect induced by observational learning. Participants (n = 60) were randomly assigned to one of three groups: a self-confident model, an unself-confident model, and a control group. In the experimental groups, participants watched a videotaped model who rated the intensity of electrocutaneous pain stimuli applied in the placebo condition as lower than those applied in the non-placebo condition. The different levels of self-confidence in these groups were manifested in the body posture and facial expressions of the model as well as in specific behavior that accompanied the assessment of pain. Then, 16 electrocutaneous pain stimuli of the same intensity, preceded by the placebo or non-placebo, were applied to participants. In both experimental groups, in contrast to the control group, participants experienced less pain in the placebo than in the non-placebo condition. Although the magnitude of placebo analgesia did not differ between the experimental groups, multiple regression analysis revealed that the perceived self-confidence of the model, but not the self-efficacy or self-esteem of the observer, was a significant predictor of the placebo effect. Moreover, placebo analgesia induced by observational learning did not extinguish over the course of the experiment. These results support the premise that the observers' perception of a model's self-confidence plays a significant role in placebo effects. PERSPECTIVE: The results of this study open the discussion on the role of model's features in the effectiveness of observational learning in the induction of placebo effects. The study provides the very first suggestion that the perceived self-confidence of the model may be related to the magnitude of the observationally induced placebo analgesia. It suggests that self-confidence of other patients and medical staff might affect individual pain experiences.",2021,"In both experimental groups, in contrast to the control group, participants experienced less pain in the placebo than in the non-placebo condition.",['Participants (N\u202f=\u202f60'],"['placebo', 'placebo or non-placebo', 'placebo analgesia']","['self-efficacy or self-esteem', 'pain']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.0562274,"In both experimental groups, in contrast to the control group, participants experienced less pain in the placebo than in the non-placebo condition.","[{'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Brączyk', 'Affiliation': 'Jagiellonian University, Institute of Psychology, Pain Research Group, Kraków, Poland.'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Bąbel', 'Affiliation': 'Jagiellonian University, Institute of Psychology, Pain Research Group, Kraków, Poland. Electronic address: przemyslaw.babel@uj.edu.pl.'}]",The journal of pain,['10.1016/j.jpain.2021.06.001']
559,34171086,A Controlled Pilot Study of the Wish Outcome Obstacle Plan Strategy for Spouses of Persons With Early-Stage Dementia.,"OBJECTIVES


Behavioral interventions can reduce distress for couples coping with early-stage dementia. However, most interventions are limited in accessibility and fail to address individualized goals. This pilot study examined the dyadic effects on multiple indicators of well-being of the Wish Outcome Obstacle Plan (WOOP) intervention, which guides participants to use Mental Contrasting with Implementation Intentions to achieve attainable goals in their daily lives.
METHODS


This randomized controlled trial included 45 older persons with early-stage dementia (PWD) and their spousal care partners (CPs: n = 90 individuals). CPs were assigned randomly to WOOP training immediately after baseline (WOOP) or after a 3-month follow-up interview (Control; CON). Both groups received a dementia care education booklet. WOOP CPs were instructed to practice WOOP at least once a day for 2 weeks. All CPs and PWDs completed home surveys (baseline, 2 weeks, and 3 months), measuring perceived stress, depressive symptoms, quality of life, and affect.
RESULTS


Mixed-effects models showed significant intervention × time interaction effects with large effect sizes for CPs on three of the five outcomes over 3 months. Compared with CON, WOOP CPs had decreased perceived stress (δ = 1.71) and increased quality of life (δ = 1.55) and positive affect (δ = 2.30). WOOP PWD showed decreased perceived stress (δ = 0.87) and increased quality of life (δ = 1.26), but these effects were not statistically significant.
DISCUSSION


WOOP is a promising, brief intervention to improve dementia CPs' well-being that may also positively affect their partners with dementia.",2022,"Compared to CON, WOOP CPs had decreased perceived stress (δ = 1.71) and increased quality of life (δ = 1.55) and positive affect (δ = 2.30).","['45 older persons with early-stage dementia (PWD) and their spousal care partners (CPs: n = 90 individuals', 'couples coping with early-stage dementia', 'Spouses of Persons with Early-Stage Dementia']","['dementia care education booklet', 'Outcome Obstacle Plan (WOOP) intervention which guides participants to use Mental Contrasting with Implementation Intentions (MCII', 'CON, WOOP CPs', 'Behavioral interventions']","['quality of life', 'perceived stress, depressive symptoms, quality of life, and affect']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",45.0,0.0402535,"Compared to CON, WOOP CPs had decreased perceived stress (δ = 1.71) and increased quality of life (δ = 1.55) and positive affect (δ = 2.30).","[{'ForeName': 'Joan K', 'Initials': 'JK', 'LastName': 'Monin', 'Affiliation': 'Social and Behavioral Sciences, Yale School of Public Health, New Haven, Connecticut, USA.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Oettingen', 'Affiliation': 'Department of Psychology, New York University, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Laws', 'Affiliation': 'Department of Psychology, University of Massachusetts, Amherst, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'David', 'Affiliation': 'Rory Meyers College of Nursing, New York University, USA.'}, {'ForeName': 'Lyndsay', 'Initials': 'L', 'LastName': 'DeMatteo', 'Affiliation': 'Social and Behavioral Sciences, Yale School of Public Health, New Haven, Connecticut, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Marottoli', 'Affiliation': 'Geriatrics, Yale School of Medicine, VA Connecticut Healthcare System, New Haven, USA.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbab115']
560,34158245,A Phase II Study Evaluating the Safety and Efficacy of Sunitinib Malate in Combination With Weekly Paclitaxel Followed by Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF as Neoadjuvant Chemotherapy for Locally Advanced or Inflammatory Breast Cancer.,"INTRODUCTION


Neoadjuvant chemotherapy is standard treatment for locally advanced breast cancer (LABC) or inflammatory breast cancer (IBC). We hypothesized that adding sunitinib, a tyrosine kinase inhibitor with antitumor and antiangiogenic activity, to an anthracycline and taxane regimen would improve pathologic complete response (pCR) rates to a prespecified endpoint of 45% in patients with HER2-negative LABC or IBC.
METHODS


We conducted a multicenter, phase II trial of neoadjuvant sunitinib with paclitaxel (S+T) followed by doxorubicin and cyclophosphamide plus G-CSF for patients with HER2-negative LABC or IBC. Patients received sunitinib 25 mg PO daily with paclitaxel 80 mg/m 2  IV weekly ×12 followed by doxorubicin 24 mg/m 2  IV weekly + cyclophosphamide 60 mg/m 2  PO daily with G-CSF support. Response was evaluated using pCR in the breast and the CPS + EG score (clinical-pathologic scoring + estrogen receptor [ER] and grade).
RESULTS


Seventy patients enrolled, and 66 were evaluable for efficacy. Eighteen patients (27%) had pCR in the breast (10 had ER +  disease and 8 had triple-negative disease). When defining response as pCR and/or CPS + EG score ≤2, 31 (47%) were responders. In pateints with ER positive disease, 23 (64%) were responders. The most common toxicities were cytopenias and fatigue.
CONCLUSIONS


Neoadjuvant S+T followed by AC+G-CSF was safe and tolerable in LABC and IBC. The study did not meet the prespecified endpoint for pCR; however, 47% were responders using pCR and/or CPS + EG score ≤2. ER positive patients had the highest response rate (64%). The addition of sunitinib to neoadjuvant chemotherapy may provide promising incremental benefit for patients with ER positive LABC.",2022,ER positive patients had the highest response rate (64%).,"['Seventy patients enrolled, and 66 were evaluable for efficacy', 'Locally Advanced or Inflammatory Breast Cancer', 'locally advanced breast cancer (LABC) or inflammatory breast cancer (IBC', 'patients with ER positive LABC', 'patients with HER2-negative LABC or IBC', 'Eighteen patients (27%) had pCR in the breast (10 had ER +  disease and 8 had triple-negative disease']","['neoadjuvant sunitinib with paclitaxel (S+T', 'Sunitinib Malate', 'anthracycline and taxane regimen', 'sunitinib 25 mg PO daily with paclitaxel', 'doxorubicin 24 mg/m 2  IV weekly\xa0+\xa0cyclophosphamide 60 mg/m 2  PO daily with G-CSF support', 'doxorubicin and cyclophosphamide plus G-CSF', 'Paclitaxel Followed by Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF', 'Neoadjuvant chemotherapy']","['highest response rate', 'pathologic complete response (pCR) rates']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278601', 'cui_str': 'Inflammatory carcinoma of breast'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1700685', 'cui_str': 'Sunitinib malate'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1702967', 'cui_str': 'sunitinib 25 MG [Sutent]'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",70.0,0.0423103,ER positive patients had the highest response rate (64%).,"[{'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Symonds', 'Affiliation': 'Medical Oncology, University of Washington, Seattle, WA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Jenkins', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Linden', 'Affiliation': 'Medical Oncology, University of Washington, Seattle, WA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kurland', 'Affiliation': 'eResearch Technologies, Inc., Pittsburgh, PA.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'Medical Oncology, University of Washington, Seattle, WA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Vijayakrishna V K', 'Initials': 'VVK', 'LastName': 'Gadi', 'Affiliation': 'Medical Oncology, University of Illinois Cancer Center, Chicago, IL.'}, {'ForeName': 'Georgiana K', 'Initials': 'GK', 'LastName': 'Ellis', 'Affiliation': 'Medical Oncology, University of Washington, Seattle, WA.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Rodler', 'Affiliation': 'Hematology and Oncology, University of California Davis, Sacramento, CA.'}, {'ForeName': 'Pavani', 'Initials': 'P', 'LastName': 'Chalasani', 'Affiliation': 'Hematology and Oncology, University of Arizona Cancer Center, Tucson, AZ.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Chai', 'Affiliation': 'Microsoft, Redmond, WA.'}, {'ForeName': 'Jinny', 'Initials': 'J', 'LastName': 'Riedel', 'Affiliation': 'Clinical Cancer Genetics, Duke Cancer Institute, Durham, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Scca Network Investigators', 'Affiliation': 'Seattle Cancer Care Alliance Network, Seattle, WA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Stopeck', 'Affiliation': 'Hematology and Oncology, Stony Brook University, Stony Brook, NY.'}, {'ForeName': 'Ursa', 'Initials': 'U', 'LastName': 'Brown-Glaberman', 'Affiliation': 'Hematology and Oncology, University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Specht', 'Affiliation': 'Medical Oncology, University of Washington, Seattle, WA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA. Electronic address: jspecht@uw.edu.'}]",Clinical breast cancer,['10.1016/j.clbc.2021.05.009']
561,34166000,Prospective evaluation of a clinical decision support system in psychological therapy.,"OBJECTIVE


Thus far, most applications in precision mental health have not been evaluated prospectively. This article presents the results of a prospective randomized-controlled trial investigating the effects of a digital decision support and feedback system, which includes two components of patient-specific recommendations: (a) a clinical strategy recommendation and (b) adaptive recommendations for patients at risk for treatment failure.
METHOD


Therapist-patient dyads ( N  = 538) in a cognitive behavioral therapy outpatient clinic were randomized to either having access to a decision support system (intervention group;  n  = 335) or not (treatment as usual;  n  = 203). First, treatment strategy recommendations (problem-solving, motivation-oriented, or a mix of both strategies) for the first 10 sessions were evaluated. Second, the effect of psychometric feedback enhanced with clinical problem-solving tools on treatment outcome was investigated.
RESULTS


The prospective evaluation showed a differential effect size of about 0.3 when therapists followed the recommended treatment strategy in the first 10 sessions. Moreover, the linear mixed models revealed therapist symptom awareness and therapist attitude and confidence as significant predictors of an outcome as well as therapist-rated usefulness of feedback as a significant moderator of the feedback-outcome and the not on track-outcome associations. However, no main effects were found for feedback.
CONCLUSIONS


The results demonstrate the importance of prospective studies and the high-quality implementation of digital decision support tools in clinical practice. Therapists seem to be able to learn from such systems and incorporate them into their clinical practice to enhance patient outcomes, but only when implementation is successful. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,"Moreover, the linear mixed models revealed therapist symptom awareness and therapist attitude and confidence as significant predictors of an outcome as well as therapist-rated usefulness of feedback as a significant moderator of the feedback-outcome and the not on track-outcome associations.","['Therapist-patient dyads ( N  = 538) in a cognitive behavioral therapy outpatient clinic', 'patients at risk for treatment failure']","['having access to a decision support system (intervention group;  n  = 335) or not (treatment as usual;  n  = 203', 'digital decision support and feedback system']",['therapist symptom awareness and therapist attitude and confidence'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}]","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0131565,"Moreover, the linear mixed models revealed therapist symptom awareness and therapist attitude and confidence as significant predictors of an outcome as well as therapist-rated usefulness of feedback as a significant moderator of the feedback-outcome and the not on track-outcome associations.","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Lutz', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Anne-Katharina', 'Initials': 'AK', 'LastName': 'Deisenhofer', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Rubel', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Bennemann', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Giesemann', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Poster', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Schwartz', 'Affiliation': 'Department of Psychology.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000642']
562,34173699,"Five-year angiographic, OCT and clinical outcomes of a randomized comparison of everolimus and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds.","AIMS


To compare 5-year angiographic, optical coherence tomography (OCT), and clinical outcomes between patients treated with bioresorbable vascular scaffolds (BVS) and drug-eluting stents (DES).
METHODS


The EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) was a single-center, assessor-blinded, randomized controlled trial in which 240 patients were randomly allocated (1:1:1) to BVS, everolimus-eluting (EES) or biolimus-eluting (BES) DES. Clinical follow-up was scheduled up to 5 years. All patients, alive and who did not have repeat revascularization of the target lesion during follow-up were asked to return for angiographic follow-up at 5 years.
RESULTS


Five-year angiographic follow-up was completed in 122 patients (51%) and OCT analysis was performed in 86 (36%) patients. In-stent late lumen loss was similar in both groups with 0.50 ± 0.38 mm in BVS versus 0.58 ± 0.36 mm in EES/BES, p = 0.20. Clinical follow-up was complete in 232 patients (97%) at 5 years. The rate of the device-oriented endpoint was 22% in the BVS and 18% in the EES/BES group (p = 0.49). The patient-oriented composite endpoint occurred in 40% of BVS- and 43% of EES/BES-treated patients (p = 0.72) at 5 years. No acute coronary syndrome due to stent thrombosis was detected after 2 years. Complete BVS strut resorption was observed at 5 years in the OCT subgroup.
CONCLUSION


Five-year clinical outcomes were similar between BVS and DES patients as well as angiographic outcomes in a selected subgroup. However, a definitive conclusion cannot be drawn because the EverBio-2 trial was not powered for clinical and angiographic endpoints at 5 years of follow-up.",2022,"In-stent late lumen loss was similar in both groups with 0.50 ± 0.38 mm in BVS versus 0.58 ± 0.36 mm in EES/BES, p = 0.20.","['240 patients', 'All patients, alive and who did not have repeat revascularization of the target lesion during follow-up were asked to return for angiographic follow-up at 5\u2009years', 'patients treated with bioresorbable vascular scaffolds (BVS) and drug-eluting stents (DES', '232 patients (97%) at 5\u2009years']","['Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold', 'BVS, everolimus-eluting (EES) or biolimus-eluting (BES) DES', 'EES/BES', 'everolimus and biolimus-eluting coronary stents with everolimus']","['acute coronary syndrome due to stent thrombosis', 'rate of the device-oriented endpoint', '5-year angiographic, optical coherence tomography (OCT), and clinical outcomes', 'angiographic outcomes', 'Complete BVS strut resorption']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0053353', 'cui_str': 'N,N-bis(2-hydroxyethyl)aminoethanesulfonic acid'}]","[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0441295', 'cui_str': 'Strut'}]",240.0,0.0598411,"In-stent late lumen loss was similar in both groups with 0.50 ± 0.38 mm in BVS versus 0.58 ± 0.36 mm in EES/BES, p = 0.20.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Schukraft', 'Affiliation': 'Cardiology, University & Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Arroyo', 'Affiliation': 'Cardiology, University & Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Togni', 'Affiliation': 'Cardiology, University & Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Goy', 'Affiliation': 'Cardiology, University & Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wenaweser', 'Affiliation': 'Cardiology, University & Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Stadelmann', 'Affiliation': 'Cardiology, University & Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Baeriswyl', 'Affiliation': 'Cardiology, University & Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Muller', 'Affiliation': 'Cardiology, University & Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Stauffer', 'Affiliation': 'Cardiology, University & Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Serban', 'Initials': 'S', 'LastName': 'Puricel', 'Affiliation': 'Cardiology, University & Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Cardiology, University & Hospital Fribourg, Fribourg, Switzerland.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29837']
563,34172326,Nandrolone decanoate safely combats catabolism in burned patients: A new potential indication after recall.,"INTRODUCTION


The hyper-catabolic state is a devastating pathophysiological response to severe injury, infection or burns. Nandrolone decanoate (ND) is a potent anabolic steroid have many clinical indications, but not investigated in burn injuries yet.
PATIENTS AND METHODS


A prospective randomized control study included 40 burned patients who were treated in Burn unit from burn injuries ranged from 20 to 40%. Both groups are objectively assessed, clinically and laboratory during treatment period till full recovery from burns' injury. Recall assessment of the drug safety after many years is achieved.
RESULTS


ND showed highly significant results supporting its use in combating catabolic insults in burns patient. Both clinical findings and laboratory findings are correlated and highly support the use of ND in burns as new effective and safe long-lasting indication.
CONCLUSION


This study results showed preservation of lean body mass and protein partition, as well as the near normal nitrogen balance in burn patients. Study proposes that nandrolone decanoate could be used in safe and effective way to combat hypercatabolic impact in burn injury.",2022,"Both clinical findings and laboratory findings are correlated and highly support the use of ND in burns as new effective and safe long-lasting indication.
","['burned patients', '40 burned patients who were treated in Burn unit from burn injuries ranged from 20 to 40', 'burn patients']","['Nandrolone decanoate (ND', 'Nandrolone decanoate', 'nandrolone decanoate']",[],"[{'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0006425', 'cui_str': 'Burns unit'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0068395', 'cui_str': 'Nandrolone decanoate'}]",[],40.0,0.00799553,"Both clinical findings and laboratory findings are correlated and highly support the use of ND in burns as new effective and safe long-lasting indication.
","[{'ForeName': 'Yasser Helmy', 'Initials': 'YH', 'LastName': 'Ali', 'Affiliation': 'Al-Azhar University, Faculty of Medicine, Naser City, Cairo, Egypt. Electronic address: dryasserhelmy@azhar.edu.eg.'}, {'ForeName': 'Tasnim', 'Initials': 'T', 'LastName': 'Ali', 'Affiliation': 'Nile University, Faculty of Biotechnology, 6th of October City, Egypt. Electronic address: t.yasserhelmy@nu.edu.eg.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2021.04.011']
564,34169381,RIC in COVID-19-a Clinical Trial to Investigate Whether Remote Ischemic Conditioning (RIC) Can Prevent Deterioration to Critical Care in Patients with COVID-19.,"PURPOSE


Coronavirus disease 19 (COVID-19) has, to date, been diagnosed in over 130 million persons worldwide and is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Several variants of concern have emerged including those in the United Kingdom, South Africa, and Brazil. SARS-CoV-2 can cause a dysregulated inflammatory response known as a cytokine storm, which can progress rapidly to acute respiratory distress syndrome (ARDS), multi-organ failure, and death. Suppressing these cytokine elevations may be key to improving outcomes. Remote ischemic conditioning (RIC) is a simple, non-invasive procedure whereby a blood pressure cuff is inflated and deflated on the upper arm for several cycles. ""RIC in COVID-19"" is a pilot, multi-center, randomized clinical trial, designed to ascertain whether RIC suppresses inflammatory cytokine production.
METHODS


A minimum of 55 adult patients with diagnosed COVID-19, but not of critical status, will be enrolled from centers in the United Kingdom, Brazil, and South Africa. RIC will be administered daily for up to 15 days. The primary outcome is the level of inflammatory cytokines that are involved in the cytokine storm that can occur following SARS-CoV-2 infection. The secondary endpoint is the time between admission and until intensive care admission or death. The in vitro cytotoxicity of patient blood will also be assessed using primary human cardiac endothelial cells.
CONCLUSIONS


The results of this pilot study will provide initial evidence on the ability of RIC to suppress the production of inflammatory cytokines in the setting of COVID-19.
TRIAL REGISTRATION


NCT04699227, registered January 7th, 2021.",2021,"SARS-CoV-2 can cause a dysregulated inflammatory response known as a cytokine storm, which can progress rapidly to acute respiratory distress syndrome (ARDS), multi-organ failure, and death.","['55 adult patients with diagnosed COVID-19, but not of critical status, will be enrolled from centers in the United Kingdom, Brazil, and South Africa', 'Patients with COVID-19']","['Remote ischemic conditioning (RIC', 'Remote Ischemic Conditioning (RIC']","['level of inflammatory cytokines that are involved in the cytokine storm that can occur following SARS-CoV-2 infection', 'time between admission and until intensive care admission or death']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0919747', 'cui_str': 'Cytokine storm'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.376844,"SARS-CoV-2 can cause a dysregulated inflammatory response known as a cytokine storm, which can progress rapidly to acute respiratory distress syndrome (ARDS), multi-organ failure, and death.","[{'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Davidson', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, 67 Chenies Mews, London, WC1E 6HX, UK.'}, {'ForeName': 'Kishal', 'Initials': 'K', 'LastName': 'Lukhna', 'Affiliation': 'Division of Cardiology, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Diana A', 'Initials': 'DA', 'LastName': 'Gorog', 'Affiliation': 'Postgraduate Medicine, University of Hertfordshire, UK & East and North Hertfordshire NHS Trust, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Salama', 'Affiliation': 'Department of Renal Medicine, Royal Free Hospital, London, UK.'}, {'ForeName': 'Alejandro Rosell', 'Initials': 'AR', 'LastName': 'Castillo', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Giesz', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, 67 Chenies Mews, London, WC1E 6HX, UK.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Golforoush', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, 67 Chenies Mews, London, WC1E 6HX, UK.'}, {'ForeName': 'Siavash Beikoghli', 'Initials': 'SB', 'LastName': 'Kalkhoran', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, 67 Chenies Mews, London, WC1E 6HX, UK.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lecour', 'Affiliation': 'The Hatter Institute for Cardiovascular Research, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Aqeela', 'Initials': 'A', 'LastName': 'Imamdin', 'Affiliation': 'The Hatter Institute for Cardiovascular Research, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Helison R P', 'Initials': 'HRP', 'LastName': 'do Carmo', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Ticiane Gonçalez', 'Initials': 'TG', 'LastName': 'Bovi', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Mauricio W', 'Initials': 'MW', 'LastName': 'Perroud', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Mpiko', 'Initials': 'M', 'LastName': 'Ntsekhe', 'Affiliation': 'Division of Cardiology, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Andrei C', 'Initials': 'AC', 'LastName': 'Sposito', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Derek M', 'Initials': 'DM', 'LastName': 'Yellon', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, 67 Chenies Mews, London, WC1E 6HX, UK. d.yellon@ucl.ac.uk.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-021-07221-y']
565,34178113,Targeting Physical Health in Schizophrenia: Results from the Physical Activity Can Enhance Life (PACE-Life) 24-Week Open Trial.,"Poor health and low cardiorespiratory fitness (CRF) contribute substantially to the shortened lifespan of individuals with schizophrenia spectrum disorders (SSDs). Increasing physical activity has demonstrated value; however, there are limited interventions that are accessible and adequately address motivational challenges. This paper reports on an open trial of Physical Activity Can Enhance Life (PACE-Life), a motivational theory-based manualized multicomponent walking intervention. The primary aim was to examine the feasibility of implementing PACE-Life through meeting the recruitment target (n=14), attendance and adherence rates, and participant feedback. The secondary aim was to assess the impact of PACE-Life on intermediate targets (autonomous motivation and satisfaction of autonomy, relatedness, and competence needs), proximal outcomes (Fitbit steps/day and minutes spent walking), the primary outcome (CRF), and secondary outcomes (loneliness, symptoms, resting heart rate, blood pressure, weight, body mass index, and hip and waist circumference). Seventeen participants with SSDs enrolled in a 24-week open trial. Assessments occurred at baseline, midpoint, post-test, and one-month follow-up. The recruitment target was exceeded, the group attendance rate was 34%, Fitbit adherence rate was 54%, and participant feedback indicated satisfaction with the intervention as well as a positive group environment. There was a large improvement in the primary outcome of CRF with 77% of participants achieving clinically significant improvement at post-test. Small and medium effect size increases were observed in autonomous motivation and satisfaction of autonomy, relatedness, and competence needs. Fitbit data and secondary outcomes generally remained unchanged or worsened during the intervention. Results from this open trial indicate that PACE-Life leads to meaningful changes in CRF among people with SSDs.",2021,There was a large improvement in the primary outcome of CRF with 77% of participants achieving clinically significant improvement at post-test.,"['Seventeen participants with SSDs enrolled in a 24-week open trial', 'Schizophrenia', 'individuals with schizophrenia spectrum disorders (SSDs']",['Physical Activity'],"['autonomous motivation and satisfaction of autonomy, relatedness, and competence needs', 'PACE-Life on intermediate targets (autonomous motivation and satisfaction of autonomy, relatedness, and competence needs), proximal outcomes (Fitbit steps/day and minutes spent walking), the primary outcome (CRF), and secondary outcomes (loneliness, symptoms, resting heart rate, blood pressure, weight, body mass index, and hip and waist circumference', 'CRF', 'Fitbit adherence rate']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",17.0,0.0821775,There was a large improvement in the primary outcome of CRF with 77% of participants achieving clinically significant improvement at post-test.,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Browne', 'Affiliation': 'Center of Excellence for Psychosocial and Systemic Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Battaglini', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'L Fredrik', 'Initials': 'LF', 'LastName': 'Jarskog', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Paschal', 'Initials': 'P', 'LastName': 'Sheeran', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Abrantes', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McDermott', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Elliott', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Penn', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Mental health and physical activity,['10.1016/j.mhpa.2021.100393']
566,34180500,Role of Yoga and Its Plausible Mechanism in the Mitigation of DNA Damage in Type-2 Diabetes: A Randomized Clinical Trial.,"BACKGROUND


Although yoga is found to be beneficial in the management of type 2 diabetes (T2D), its mechanism of action is poorly understood. T2D is also known to be associated with increased oxidative stress (OS) and DNA damage.
PURPOSE


This study examines how yoga modulates OS-induced DNA damage and the efficiency of DNA repair in T2D conditions.
METHODS


In this assessor-masked randomized clinical trial, T2D subjects (n = 61), aged (Mean ± SD, 50.3 ± 4.2) were randomly allocated into Yoga group (31) that received 10 weeks of yoga intervention and Control (30) with routine exercises. Molecular and biochemical assessments were done before and after the intervention period. Structural Equation Modeling using ""R"" was used for mediation analysis.
RESULTS


At the end of the 10th week, Yoga group showed significant reduction in DNA damage indicators like Tail Moment (-5.88[95%CI: -10.47 to -1.30]; P = .013) and Olive Tail Moment (-2.93[95%CI: -4.87 to -1.00]; P < .01), oxidative DNA damage marker 8-OHdG (-60.39[95%CI: -92.55 to -28.23]; P < .001) and Fasting Blood Sugar (-22.58[95%CI: -44.33 to -0.83]; P = .042) compared to Control. OGG1 protein expression indicating DNA repair, improved significantly (17.55[95%CI:1.37 to 33.73]; P = .034) whereas Total Antioxidant Capacity did not (5.80[95%CI: -0.86 to 12.47]; P = 0.086). Mediation analysis indicated that improvements in oxidative DNA damage and DNA repair together played a major mediatory role (97.4%) in carrying the effect of yoga.
CONCLUSION


The beneficial effect of yoga on DNA damage in T2D subjects was found to be mediated by mitigation of oxidative DNA damage and enhancement of DNA repair.
CLINICAL TRIAL INFORMATION


(www.ctri.nic.in) CTRI/2018/07/014825.",2022,"OGG1 protein expression indicating DNA repair, improved significantly (17.55[95%CI:1.37 to 33.73]; P = .034) whereas Total Antioxidant Capacity did not (5.80[95%CI: -0.86 to 12.47]; P = 0.086).","['Type-2 Diabetes', 'T2D subjects', 'T2D subjects (n\u2005=\u200561), aged (Mean ± SD, 50.3 ± 4.2']",['yoga intervention and Control (30) with routine exercises'],"['oxidative stress (OS) and DNA damage', 'Fasting Blood Sugar (-22.58[95%CI', 'oxidative DNA damage marker 8-OHdG', 'Total Antioxidant Capacity', 'OGG1 protein expression indicating DNA repair', 'DNA damage indicators like Tail Moment ']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517758', 'cui_str': '4.2'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C1313359', 'cui_str': 'oxoguanine glycosylase 1, human'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0012899', 'cui_str': 'DNA repair'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0039259', 'cui_str': 'Tail'}]",,0.247625,"OGG1 protein expression indicating DNA repair, improved significantly (17.55[95%CI:1.37 to 33.73]; P = .034) whereas Total Antioxidant Capacity did not (5.80[95%CI: -0.86 to 12.47]; P = 0.086).","[{'ForeName': 'Rajesh G', 'Initials': 'RG', 'LastName': 'Nair', 'Affiliation': 'Molecular Bioscience Lab, Anvesana Research Labs, S-VYASA, Bangalore, India.'}, {'ForeName': 'Mithila M', 'Initials': 'MM', 'LastName': 'Vasudev', 'Affiliation': 'Molecular Bioscience Lab, Anvesana Research Labs, S-VYASA, Bangalore, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Mavathur', 'Affiliation': 'Molecular Bioscience Lab, Anvesana Research Labs, S-VYASA, Bangalore, India.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaab043']
567,34176862,Timing of Intervention in Asymptomatic Aortic Stenosis.,"The decision to perform an intervention for asymptomatic severe aortic stenosis (AS) requires careful weighing of the risks of early intervention against those of watchful observation, and the optimal timing of intervention remains controversial. With improvements in surgical and postoperative care, long-term survival after surgical aortic valve (AV) replacement (AVR) is excellent in low-risk patients, and the emergence of transcatheter AVR may change the thresholds for early preemptive intervention, although a durability issue has to be resolved. A watchful observation strategy also has a risk of sudden death, irreversible myocardial damage, and increase in operative risk while waiting for symptoms to develop. We have been waiting for a prospective randomized trial to solve the intense debate between early AVR and watchful observation, and the RECOVERY (Randomized Comparison of Early Surgery versus Conventional Treatment in Very Severe Aortic Stenosis) trial provides the evidence to support early AVR for asymptomatic severe AS. Risk assessment with severity of AS and staging classification may help to facilitate the identification of patients who may benefit from early intervention. Based on the results of the RECOVERY trial, early surgical AVR is reasonable for asymptomatic patients with very severe AS (aortic jet velocity ≥4.5 m/s) and low surgical risk. Further evidence is required to extend the indications of surgical AVR and to consider transcatheter AVR in asymptomatic patients with severe AS.",2022,"The decision to perform an intervention for asymptomatic severe aortic stenosis (AS) requires careful weighing of the risks of early intervention against those of watchful observation, and the optimal timing of intervention remains controversial.","['asymptomatic patients with very severe AS (aortic jet velocity ≥4.5 m/s) and low surgical risk', 'Asymptomatic Aortic Stenosis', 'asymptomatic severe aortic stenosis (AS', 'Very Severe Aortic Stenosis', 'low-risk patients', 'asymptomatic patients with severe AS']","['surgical aortic valve (AV) replacement (AVR', 'Early Surgery versus Conventional Treatment']",[],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0449217', 'cui_str': 'aVR'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0218727,"The decision to perform an intervention for asymptomatic severe aortic stenosis (AS) requires careful weighing of the risks of early intervention against those of watchful observation, and the optimal timing of intervention remains controversial.","[{'ForeName': 'Seung-Ah', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan.'}, {'ForeName': 'Duk-Hyun', 'Initials': 'DH', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-21-0200']
568,34176245,The efficacy and cost-effectiveness of a family-based economic empowerment intervention (Suubi + Adherence) on suppression of HIV viral loads among adolescents living with HIV: results from a Cluster Randomized Controlled Trial in southern Uganda.,"INTRODUCTION


Evidence from low-resource settings indicates that economic insecurity is a major barrier to HIV treatment adherence. Economic empowerment (EE) interventions have the potential to improve adherence outcomes among adolescents living with HIV (ALWHIV) by mitigating the effects of poverty. This study aims to assess the efficacy and cost-effectiveness of a savings-led family-based EE intervention, Suubi + Adherence, aimed at improving antiretroviral therapy (ART) adherence outcomes ALWHIV in Uganda.
METHODS


Adolescents (mean age 12 years at enrolment; 56% female) receiving ART for HIV at 39 health centres were randomized to Suubi + Adherence intervention (n = 358) or bolstered standard of care (BSOC; n = 344). A difference-in-differences analysis was employed to assess the change in the proportion of virally suppressed adolescents (HIV RNA viral load <40 copies/mL) over 24 months. The cost-effectiveness analysis examined how much the intervention cost to virally suppress one additional adolescent relative to BSOC from the healthcare provider perspective.
RESULTS


At 24 months, the intervention was associated with an 8.85-percentage point [95% confidence interval (CI) 0.80 to 16.90 percentage points] increase in the proportion of virally suppressed adolescents between the study arms (p = 0.032). Per-participant costs were US$177 and US$263 for the BSOC and intervention groups respectively. The incremental cost of virally suppressing one additional adolescent was estimated at US$970 [95% CI, US$508 to 10,725] over two years.
CONCLUSIONS


Our results support the integration of family-based EE interventions into adherence-support strategies as part of routine HIV care in low-resource settings to address the underlying economic drivers of poor ART adherence among ALWHIV. Moreover, per-participant costs to achieve viral suppression do not seem prohibitive compared to other community-based adherence interventions targeted at ALWHIV in low-resource settings. Further research on combination interventions at the nexus of economic security and HIV treatment and care is needed to inform the development of feasible and scalable HIV policies and programmes.",2021,Economic empowerment (EE) interventions have the potential to improve adherence outcomes among adolescents living with HIV (ALWHIV) by mitigating the effects of poverty.,"['Adolescents (mean age 12\xa0years at enrolment; 56% female) receiving ART for HIV at 39 health centres', 'southern Uganda', 'adolescents living with HIV', 'adolescents living with HIV (ALWHIV', 'Uganda']","['savings-led family-based EE intervention, Suubi\xa0+\xa0Adherence', 'family-based economic empowerment intervention (Suubi\xa0+\xa0Adherence', 'Economic empowerment (EE) interventions', 'Suubi\xa0+\xa0Adherence intervention (n\xa0=\xa0358) or bolstered standard of care (BSOC']","['HIV viral loads', 'incremental cost of virally suppressing one additional adolescent', 'efficacy and cost-effectiveness']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.201518,Economic empowerment (EE) interventions have the potential to improve adherence outcomes among adolescents living with HIV (ALWHIV) by mitigating the effects of poverty.,"[{'ForeName': 'Yesim', 'Initials': 'Y', 'LastName': 'Tozan', 'Affiliation': 'School of Global Public Health, New York University, New York, NY, USA.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Capasso', 'Affiliation': 'School of Global Public Health, New York University, New York, NY, USA.'}, {'ForeName': 'Sicong', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Brown School, Washington University in Saint Louis, Saint Louis, MO, USA.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Center for AIDS Prevention Studies, School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'International Center for Child Health and Development, Washington University in St. Louis, Uganda Field Office, Masaka, Uganda.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Namuwonge', 'Affiliation': 'International Center for Child Health and Development, Washington University in St. Louis, Uganda Field Office, Masaka, Uganda.'}, {'ForeName': 'Gertrude', 'Initials': 'G', 'LastName': 'Nakigozi', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Mwebembezi', 'Affiliation': 'International Center for Child Health and Development, Washington University in St. Louis, Uganda Field Office, Masaka, Uganda.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mukasa', 'Affiliation': 'Mildmay Uganda, Kampala, Uganda.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'Brown School, Washington University in Saint Louis, Saint Louis, MO, USA.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'Brown School, Washington University in Saint Louis, Saint Louis, MO, USA.'}, {'ForeName': 'Claude A', 'Initials': 'CA', 'LastName': 'Mellins', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Department of Psychiatry, New York State Psychiatric Institute and Columbia University, New York, NY, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McKay', 'Affiliation': 'Brown School, Washington University in Saint Louis, Saint Louis, MO, USA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Brown School, Washington University in Saint Louis, Saint Louis, MO, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25752']
569,34189934,Maintenance of Training Effects of Two Models for Implementing Evidence-Based Psychological Treatment.,"OBJECTIVE


The authors compared maintenance of training outcomes for two approaches to training college therapists in interpersonal psychotherapy (IPT): train the trainer versus expert training.
METHODS


A cluster-randomized trial was conducted in 24 college counseling centers. Therapists were recruited from enrolled centers, and the therapists enrolled students with depression and eating disorder symptoms. The therapists (N=184) provided data during baseline, posttraining (during the 12 months of expert consultation offered to the expert training group), and maintenance (approximately 7 months after the expert consultation ended). Outcomes were therapist fidelity (i.e., adherence and competence) and IPT knowledge.
RESULTS


Both groups showed within-group improvement from baseline to the maintenance period for adherence, competence, and IPT knowledge; however, the train-the-trainer group had greater improvement over time in adherence and competence.
CONCLUSIONS


Given that the effects of the train-the-trainer approach were better maintained, and this model's potential to train more therapists over time, the train-the-trainer approach may help increase dissemination of evidence-based treatments such as IPT.",2021,"Both groups showed within-group improvement from baseline to the maintenance period for adherence, competence, and IPT knowledge; however, the train-the-trainer group had greater improvement over time in adherence and competence.
","['24 college counseling centers', 'Therapists were recruited from enrolled centers, and the therapists enrolled students with depression and eating disorder symptoms']",['interpersonal psychotherapy (IPT): train the trainer versus expert training'],"['time in adherence and competence', 'therapist fidelity (i.e., adherence and competence) and IPT knowledge', 'adherence, competence, and IPT knowledge']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}]","[{'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0244856,"Both groups showed within-group improvement from baseline to the maintenance period for adherence, competence, and IPT knowledge; however, the train-the-trainer group had greater improvement over time in adherence and competence.
","[{'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Fitzsimmons-Craft', 'Affiliation': 'Department of Psychiatry (Fitzsimmons-Craft, Laing, Welch, Wilfley), Washington University School of Medicine, and the George Warren Brown School of Social Work (Proctor), Washington University, St. Louis; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California (Bohon, Jo, Mondal, Agras); Graduate School of Applied and Professional Psychology, Rutgers, State University of New Jersey, Piscataway (Wilson); Silver School of Social Work, New York University, New York City (Raghavan).'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Bohon', 'Affiliation': 'Department of Psychiatry (Fitzsimmons-Craft, Laing, Welch, Wilfley), Washington University School of Medicine, and the George Warren Brown School of Social Work (Proctor), Washington University, St. Louis; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California (Bohon, Jo, Mondal, Agras); Graduate School of Applied and Professional Psychology, Rutgers, State University of New Jersey, Piscataway (Wilson); Silver School of Social Work, New York University, New York City (Raghavan).'}, {'ForeName': 'G Terence', 'Initials': 'GT', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychiatry (Fitzsimmons-Craft, Laing, Welch, Wilfley), Washington University School of Medicine, and the George Warren Brown School of Social Work (Proctor), Washington University, St. Louis; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California (Bohon, Jo, Mondal, Agras); Graduate School of Applied and Professional Psychology, Rutgers, State University of New Jersey, Piscataway (Wilson); Silver School of Social Work, New York University, New York City (Raghavan).'}, {'ForeName': 'Booil', 'Initials': 'B', 'LastName': 'Jo', 'Affiliation': 'Department of Psychiatry (Fitzsimmons-Craft, Laing, Welch, Wilfley), Washington University School of Medicine, and the George Warren Brown School of Social Work (Proctor), Washington University, St. Louis; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California (Bohon, Jo, Mondal, Agras); Graduate School of Applied and Professional Psychology, Rutgers, State University of New Jersey, Piscataway (Wilson); Silver School of Social Work, New York University, New York City (Raghavan).'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Mondal', 'Affiliation': 'Department of Psychiatry (Fitzsimmons-Craft, Laing, Welch, Wilfley), Washington University School of Medicine, and the George Warren Brown School of Social Work (Proctor), Washington University, St. Louis; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California (Bohon, Jo, Mondal, Agras); Graduate School of Applied and Professional Psychology, Rutgers, State University of New Jersey, Piscataway (Wilson); Silver School of Social Work, New York University, New York City (Raghavan).'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Laing', 'Affiliation': 'Department of Psychiatry (Fitzsimmons-Craft, Laing, Welch, Wilfley), Washington University School of Medicine, and the George Warren Brown School of Social Work (Proctor), Washington University, St. Louis; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California (Bohon, Jo, Mondal, Agras); Graduate School of Applied and Professional Psychology, Rutgers, State University of New Jersey, Piscataway (Wilson); Silver School of Social Work, New York University, New York City (Raghavan).'}, {'ForeName': 'R Robinson', 'Initials': 'RR', 'LastName': 'Welch', 'Affiliation': 'Department of Psychiatry (Fitzsimmons-Craft, Laing, Welch, Wilfley), Washington University School of Medicine, and the George Warren Brown School of Social Work (Proctor), Washington University, St. Louis; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California (Bohon, Jo, Mondal, Agras); Graduate School of Applied and Professional Psychology, Rutgers, State University of New Jersey, Piscataway (Wilson); Silver School of Social Work, New York University, New York City (Raghavan).'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Raghavan', 'Affiliation': 'Department of Psychiatry (Fitzsimmons-Craft, Laing, Welch, Wilfley), Washington University School of Medicine, and the George Warren Brown School of Social Work (Proctor), Washington University, St. Louis; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California (Bohon, Jo, Mondal, Agras); Graduate School of Applied and Professional Psychology, Rutgers, State University of New Jersey, Piscataway (Wilson); Silver School of Social Work, New York University, New York City (Raghavan).'}, {'ForeName': 'Enola K', 'Initials': 'EK', 'LastName': 'Proctor', 'Affiliation': 'Department of Psychiatry (Fitzsimmons-Craft, Laing, Welch, Wilfley), Washington University School of Medicine, and the George Warren Brown School of Social Work (Proctor), Washington University, St. Louis; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California (Bohon, Jo, Mondal, Agras); Graduate School of Applied and Professional Psychology, Rutgers, State University of New Jersey, Piscataway (Wilson); Silver School of Social Work, New York University, New York City (Raghavan).'}, {'ForeName': 'W Stewart', 'Initials': 'WS', 'LastName': 'Agras', 'Affiliation': 'Department of Psychiatry (Fitzsimmons-Craft, Laing, Welch, Wilfley), Washington University School of Medicine, and the George Warren Brown School of Social Work (Proctor), Washington University, St. Louis; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California (Bohon, Jo, Mondal, Agras); Graduate School of Applied and Professional Psychology, Rutgers, State University of New Jersey, Piscataway (Wilson); Silver School of Social Work, New York University, New York City (Raghavan).'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Department of Psychiatry (Fitzsimmons-Craft, Laing, Welch, Wilfley), Washington University School of Medicine, and the George Warren Brown School of Social Work (Proctor), Washington University, St. Louis; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California (Bohon, Jo, Mondal, Agras); Graduate School of Applied and Professional Psychology, Rutgers, State University of New Jersey, Piscataway (Wilson); Silver School of Social Work, New York University, New York City (Raghavan).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.202000702']
570,34182895,The Embodiment of an Older Avatar in a Virtual Reality Setting Impacts the Social Motivation of Young Adults.,"OBJECTIVES


Socio-emotional selectivity theory implies that an individual's motives change over their lifespan, starting with a focus on information seeking and shifting toward the motivation of maintaining emotionally meaningful social relationships in old age. The concept of future time perspective serves as an underlying mechanism for this phenomenon.
METHODS


This study aimed to capture how social motivation changes as a result of the manipulation of one's own visual appearance. Thus, the explicit age stereotypes of  N  = 74 participants were assessed, among other covariates. The following intervention consisted of a virtual reality (VR) scenario in which the experimental group embodied an old age avatar and the control group a young age avatar.
RESULTS


Changes in social motivation were assessed using the concept of socio-emotional selectivity based on imagined situational preferences. Results with strong effect sizes indicate that changes in social motivation commonly connected with old age might be caused by visual cues when actively embodying a virtual avatar.",2022,"The following intervention consisted of a virtual reality (VR) scenario in which the experimental group embodied an old age avatar and the control group a young age avatar.
",['Young Adults'],['virtual reality (VR) scenario in which the experimental group embodied an old age avatar and the control group a young age avatar'],['social motivation'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}]",74.0,0.0378577,"The following intervention consisted of a virtual reality (VR) scenario in which the experimental group embodied an old age avatar and the control group a young age avatar.
","[{'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Vahle', 'Affiliation': 'Department of Psychology and Psychotherapy, University of Witten-Herdecke, Witten, Germany.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Tomasik', 'Affiliation': 'Department of Psychology and Psychotherapy, University of Witten-Herdecke, Witten, Germany.'}]",Experimental aging research,['10.1080/0361073X.2021.1943793']
571,34193407,Mucositis reduction with probiotics in children with cancer: a randomised-controlled feasibility study.,"BACKGROUND


A recent systematic review and meta-analysis identified a paucity of randomised-controlled trials (RCTs) investigating the use of probiotics to reduce or prevent mucositis and infection in children with cancer.
OBJECTIVE


This study evaluated the feasibility of undertaking an RCT and investigated the efficacy of probiotics for reducing or preventing mucositis and infection in children with cancers.
SETTING


The Paediatric Oncology and Haematology department at Leeds Teaching Hospital, UK.
PATIENTS


Children aged 1 year or older, receiving chemotherapies likely to cause mucositis.
INTERVENTIONS


Participants were randomised to receive the probiotic or placebo on day 1-14 of a chemotherapy cycle. Participants were also required to complete a patient diary for 21 days.
MAIN OUTCOME MEASURES


To assess whether it is feasible to recruit children diagnosed with cancer who are at risk of developing mucositis to an adequately powered RCT.
RESULTS


Between May and November 2019, 34 out of 39 eligible participants were approached. Ten patients were recruited (4 probiotic and 6 placebo) of which 2 participants withdrew. Seven participants partially completed the diary but only two participants completed 80% or more. Eligible participants appeared to prefer giving informal verbal feedback when in direct contact with research and healthcare professionals.
CONCLUSION


This study demonstrated that recruitment needs to be improved prior to undertaking an adequately powered RCT.
TRIAL REGISTRATION NUMBER


NCT03785938.",2022,"This study evaluated the feasibility of undertaking an RCT and investigated the efficacy of probiotics for reducing or preventing mucositis and infection in children with cancers.
","['children with cancer', 'Between May and November 2019', ' 34 out of 39 eligible participants were approached', 'children diagnosed with cancer who are at risk of developing mucositis to an adequately powered RCT', 'Eligible participants', 'children with cancers', 'The Paediatric Oncology and Haematology department at Leeds Teaching Hospital, UK', 'Ten patients were recruited (4 probiotic and 6 placebo) of which 2 participants withdrew', 'Children aged 1\u2009year or older, receiving chemotherapies likely to cause mucositis']",['probiotic or placebo'],"['informal verbal feedback', 'Mucositis reduction']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0587491', 'cui_str': 'Hematology department'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",39.0,0.614623,"This study evaluated the feasibility of undertaking an RCT and investigated the efficacy of probiotics for reducing or preventing mucositis and infection in children with cancers.
","[{'ForeName': 'Hadeel', 'Initials': 'H', 'LastName': 'Hassan', 'Affiliation': 'Leeds Institute of Cancer and Pathology, University of Leeds, Faculty of Medicine and Health, Leeds, UK hadeelhassan@doctors.org.uk.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kinsey', 'Affiliation': 'Leeds Institute of Cancer and Pathology, University of Leeds, Faculty of Medicine and Health, Leeds, UK.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Phillips', 'Affiliation': 'Centre for Reviews and Dissemination, University of York Alcuin College, York, UK.'}]",Archives of disease in childhood,['10.1136/archdischild-2020-319968']
572,34216552,"The Effect of Convergence Gamification Training in Community-Dwelling Older People: A Multicenter, Randomized Controlled Trial.","OBJECTIVES


It is necessary to improve the health of older adults through exercise, but there is no concrete way to implement it or an environment in which they can exercise continuously. Our objective was to confirm the safety and efficacy of information technology (IT) convergence gamification exercise equipment for older adults. We tried to demonstrate equivalence to conventional exercise by comparing the functional improvement.
DESIGN


Randomized controlled trial, with 8-week-long IT convergence exercises 3 times a week vs conventional exercise.
SETTING AND PARTICIPANTS


40 community-dwelling participants aged 60-85 years.
METHOD


Participants were randomly divided into a conventional exercise group (group 1) and an IT convergence exercise group (group 2). Both groups were trained for 8 weeks, and functional assessment was performed before training (pre-evaluation), after training, and after 4 weeks of rest.
RESULTS


There were functional improvements in both groups. A comparison of the differences in the functional assessment between pre-evaluation and after 8 weeks of training yielded the following results. In group 1, the mean Five Times Sit to Stand Test-30 seconds was scored as 3.60 ± 2.56 (P < .015); Five Times Sit to Stand Test-5 times, -1.75 ± 2.04 s (P < .015); Berg Balance Scale, 1.05 ± 1.39 (P < .015); Timed Up-and-Go test, -0.64 ± 0.64 s (P < .015); and 10-m Walking Test, -0.35 ± 0.47 s (P < .015). And in group 2, the mean Five Times Sit to Stand Test-30 seconds (s) was scored as 3.70 ± 2.62 (P < .015), Five Times Sit to Stand Test-5 times, -1.65 ± 1.59 s (P < .015); Berg Balance Scale, 1.05 ± 1.00 (P < .015); Timed Up-and-Go test, -0.93 ± 0.68 s (P < .015); 10-m Walking Test, -0.41 ± 0.489 s (P < .015); Chair Sit and Reach test, 2.23 ± 3.19 cm (P < .015); and Korean version of the Falls Efficacy Scale-International, -1.05 ± 1.43 (P < .015).
CONCLUSION AND IMPLICATIONS


The results of this study suggest that the IT convergence gamification exercise equipment such as balpro110 has exercise effects similar to conventional exercise and also has advantages as an alternative to exercise for older adults in the next generation.",2022,"Five Times Sit to Stand Test-5 times, -1.75 ± 2.04 (P < .015); Berg Balance Scale, 1.05 ± 1.39 (P < .015); Timed Up-and-Go test, -0.64 ± 0.64 (P < .015); and 10-m Walking Test, -0.35 ± 0.47 (P < .015).","['Community-Dwelling Older People', '40 community-dwelling participants aged 60-85\xa0years', 'Participants', 'older adults']","['IT convergence exercise group', 'information technology (IT) convergence gamification exercise equipment', 'conventional exercise', 'Information Technology Convergence Gamification Training']","['Korean version of the Falls Efficacy Scale', 'mean Five Times Sit to Stand']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0021423', 'cui_str': 'Information Sciences'}, {'cui': 'C0443193', 'cui_str': 'Convergence'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}]",40.0,0.0195028,"Five Times Sit to Stand Test-5 times, -1.75 ± 2.04 (P < .015); Berg Balance Scale, 1.05 ± 1.39 (P < .015); Timed Up-and-Go test, -0.64 ± 0.64 (P < .015); and 10-m Walking Test, -0.35 ± 0.47 (P < .015).","[{'ForeName': 'Eun-Lee', 'Initials': 'EL', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Biomedical Research Institute of Pusan National University Hospital, Pusan, Republic of Korea; Department of Public health, Graduate School, Inje University, Pusan, Republic of Korea.'}, {'ForeName': 'Myoung-Hwan', 'Initials': 'MH', 'LastName': 'Ko', 'Affiliation': 'Department of Physical Medicine and Rehabilitation of Jeonbuk National University Medical School, Jeonju, Republic of Korea; Research Institute of Clinical Medicine of Jeonbuk National University-Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Myung-Jun', 'Initials': 'MJ', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, Biomedical Research Institute of Pusan National University Hospital, Pusan, Republic of Korea. Electronic address: drshinmj@gmail.com.'}, {'ForeName': 'Byeong-Ju', 'Initials': 'BJ', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Biomedical Research Institute of Pusan National University Hospital, Pusan, Republic of Korea.'}, {'ForeName': 'Da Hwi', 'Initials': 'DH', 'LastName': 'Jung', 'Affiliation': 'Department of Rehabilitation Medicine, Biomedical Research Institute of Pusan National University Hospital, Pusan, Republic of Korea.'}, {'ForeName': 'Kap-Soo', 'Initials': 'KS', 'LastName': 'Han', 'Affiliation': 'Research Institute of Clinical Medicine of Jeonbuk National University-Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Jin Mi', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics, Clinical Trial Center, Biomedical Research Institute, Pusan National University Hospital, Pusan, Republic of Korea.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2021.05.041']
573,34215673,"A Randomized, Factorial Phase II Study to Determine the Optimal Dosing Regimen for  68 Ga-Satoreotide Trizoxetan as an Imaging Agent in Patients with Gastroenteropancreatic Neuroendocrine Tumors.","68 Ga-satoreotide trizoxetan is a novel somatostatin receptor antagonist associated with high sensitivity and reproducibility in neuroendocrine tumor (NET) detection and localization. However, the optimal peptide mass and radioactivity ranges for  68 Ga-satoreotide trizoxetan have not yet been established. We therefore aimed to determine its optimal dosing regimen in patients with metastatic gastroenteropancreatic NETs in a prospective, randomized, 2 × 3 factorial, multicenter phase II study.  Methods:  Patients received  68 Ga-satoreotide trizoxetan at a peptide mass of 5-20 µg on day 1 of the study and of 30-45 µg on days 16-22, at 1 of 3  68 Ga radioactivity ranges (40-80, 100-140, or 160-200 MBq). Whole-body PET/CT imaging was performed 50-70 min after each injection. The primary endpoint was the detection rate of NET lesions imaged by  68 Ga-satoreotide trizoxetan relative to contrast-enhanced CT (for each of the 6 peptide mass and radioactivity range combinations).  Results:  Twenty-four patients were evaluated in the per-protocol analysis. The median number of lesions detected by  68 Ga-satoreotide trizoxetan PET/CT or PET alone was at least twice as high as the number detected by contrast-enhanced CT across the 6 studied peptide mass and radioactivity range combinations. There were no differences between the 2 peptide mass ranges or between the 3 radioactivity ranges in the number of identified lesions. However, a trend toward a lower relative lesion count was noted in the liver for the 40- to 80-MBq range. No relationship was observed between the radioactivity range per patient's body weight (MBq/kg) and the number of lesions detected by  68 Ga-satoreotide trizoxetan. The median diagnostic sensitivity of  68 Ga-satoreotide trizoxetan PET/CT, based on the number of lesions per patient, ranged from 85% to 87% across the different peptide mass and radioactivity ranges. Almost all reported adverse events were mild and self-limiting.  Conclusion:  A radioactivity of 100-200 MBq with a peptide mass of up to 50 µg was confirmed as the optimal dosing regimen for  68 Ga-satoreotide trizoxetan to be used in future phase III studies.",2022,"However, a trend towards a lower relative lesion count was noted in the liver for the 40-80 MBq range.","['patients with metastatic gastroenteropancreatic NETs', 'patients with gastroenteropancreatic neuroendocrine tumours']",['68 Ga-satoreotide trizoxetan'],"['adverse events', 'median number of lesions', 'relative lesion count', 'detection rate of NET lesions imaged by  68 Ga-satoreotide trizoxetan relative to contrast-enhanced CT (CECT', 'Median diagnostic sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C2930967', 'cui_str': 'Gastro-enteropancreatic neuroendocrine tumor'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}]","[{'cui': 'C0303226', 'cui_str': 'Gallium-68'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449791', 'cui_str': 'Number of lesions'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0303226', 'cui_str': 'Gallium-68'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",24.0,0.0692987,"However, a trend towards a lower relative lesion count was noted in the liver for the 40-80 MBq range.","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Virgolini', 'Affiliation': 'Department of Nuclear Medicine, University of Innsbruck, Innsbruck, Austria; irene.virgolini@i-med.ac.at.'}, {'ForeName': 'Shadfar', 'Initials': 'S', 'LastName': 'Bahri', 'Affiliation': 'Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, UCLA, Los Angeles, California.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kjaer', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine and PET and Cluster for Molecular Imaging, Department of Biomedical Sciences, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Grønbæk', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Iversen', 'Affiliation': 'Department of Nuclear Medicine and PET Center, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Esben A', 'Initials': 'EA', 'LastName': 'Carlsen', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine and PET and Cluster for Molecular Imaging, Department of Biomedical Sciences, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Loft', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine and PET and Cluster for Molecular Imaging, Department of Biomedical Sciences, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Knigge', 'Affiliation': 'Department of Endocrinology PE and Department of Surgery C, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Maffey-Steffan', 'Affiliation': 'Department of Nuclear Medicine, University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'Ipsen Bioscience, Cambridge, Massachusetts.'}, {'ForeName': 'Colin G', 'Initials': 'CG', 'LastName': 'Miller', 'Affiliation': 'Bracken Group for Ipsen Bioscience, Newtown, Pennsylvania; and.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rohban', 'Affiliation': 'Partner 4 Health for Ipsen Bioscience, Paris, France.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'McEwan', 'Affiliation': 'Ipsen Bioscience, Cambridge, Massachusetts.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Czernin', 'Affiliation': 'Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, UCLA, Los Angeles, California.'}]","Journal of nuclear medicine : official publication, Society of Nuclear Medicine",['10.2967/jnumed.121.261936']
574,34213861,Understanding Engagement in and Affective Experiences During Physical Activity: The Role of Meditation Interventions.,"OBJECTIVE


Meditation interventions promote an array of well-being outcomes. However, the way in which these interventions promote beneficial outcomes is less clear. Here, we expanded on prior work by examining the influence of mindfulness and loving-kindness meditation on a key health behavior: physical activity.
METHODS


To test our hypotheses, we drew upon two randomized intervention studies. In the first study, 171 adults (73.0% female) received 6 weeks of training in either mindfulness meditation or loving-kindness meditation, or were assigned to a control condition. In the second study, 124 adults (60.0% female) were assigned to a 6-week mindfulness or loving-kindness meditation group.
RESULTS


Study 1 demonstrated that individuals who received mindfulness training reported sustained levels of physical activity across the intervention period (Pre: mean [standard deviation], or M [SD] = 4.09 [2.07]; Post: M [SD] = 3.68 [2.00]; p = .054), whereas those in the control (Pre: M [SD] = 3.98 [2.25]; Post: M [SD] = 3.01 [2.07]; p < .001) and loving-kindness (Pre: M [SD] = 4.11 [2.26]; Post: M [SD] = 3.45 [1.96]; p < .001) conditions reported lower levels. Study 2 demonstrated those who received mindfulness training experienced increases in positive emotions during physical activity from preintervention to postintervention (Pre: M [SD] = 6.06 [2.51]; Post: M [SD] = 6.54 [2.43]; p = .001), whereas those trained in loving-kindness meditation experienced decreases in positive emotions during physical activity (Pre: M [SD] = 6.45 [2.35]; Post: M [SD] = 6.09 [2.46]; p = .040).
CONCLUSIONS


These results suggest mindfulness training (but not loving-kindness training) promotes sustained physical activity, and one plausible reason why this occurs is enhanced positive emotion during physical activity.",2021,"Study 2 demonstrated those who received mindfulness training experienced increases in positive emotions during physical activity from preintervention to postintervention (Pre: M [SD] = 6.06 [2.51]; Post: M [SD] = 6.54 [2.43]; p = .001), whereas those trained in loving-kindness meditation experienced decreases in positive emotions during physical activity (Pre: M [SD] = 6.45 [2.35]; Post: M [SD] = 6.09 [2.46]; p = .040).
","['Affective Experiences', '171 adults (73.0% female', '124 adults (60.0% female']","['training in either mindfulness meditation or loving-kindness meditation', '6-week mindfulness or loving-kindness meditation group', 'mindfulness training']","['positive emotions during physical activity', 'loving-kindness', 'sustained levels of physical activity']","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517553', 'cui_str': '124'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",171.0,0.0227221,"Study 2 demonstrated those who received mindfulness training experienced increases in positive emotions during physical activity from preintervention to postintervention (Pre: M [SD] = 6.06 [2.51]; Post: M [SD] = 6.54 [2.43]; p = .001), whereas those trained in loving-kindness meditation experienced decreases in positive emotions during physical activity (Pre: M [SD] = 6.45 [2.35]; Post: M [SD] = 6.09 [2.46]; p = .040).
","[{'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Don', 'Affiliation': 'From the University of North Carolina at Chapel Hill (Don), Chapel Hill; Duke University (Van Cappellen), Durham; and University of North Carolina at Chapel Hill (Fredrickson), Chapel Hill, California.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Van Cappellen', 'Affiliation': ''}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Fredrickson', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000909']
575,34196693,Use of Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: Initial Results From the Pembrolizumab Arm of a Phase 2 Randomized Clinical Trial.,"Importance


Total neoadjuvant therapy (TNT) is often used to downstage locally advanced rectal cancer (LARC) and decrease locoregional relapse; however, more than one-third of patients develop recurrent metastatic disease. As such, novel combinations are needed.
Objective


To assess whether the addition of pembrolizumab during and after neoadjuvant chemoradiotherapy can lead to an improvement in the neoadjuvant rectal (NAR) score compared with treatment with FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin) and chemoradiotherapy alone.
Design, Setting, and Participants


In this open-label, phase 2, randomized clinical trial (NRG-GI002), patients in academic and private practice settings were enrolled. Patients with stage II/III LARC with distal location (cT3-4 ≤ 5 cm from anal verge, any N), with bulky disease (any cT4 or tumor within 3 mm of mesorectal fascia), at high risk for metastatic disease (cN2), and/or who were not candidates for sphincter-sparing surgery (SSS) were stratified based on clinical tumor and nodal stages. Trial accrual opened on August 1, 2018, and ended on May 31, 2019. This intent-to-treat analysis is based on data as of August 2020.
Interventions


Patients were randomized (1:1) to neoadjuvant FOLFOX for 4 months and then underwent chemoradiotherapy (capecitabine with 50.4 Gy) with or without intravenous pembrolizumab administered at a dosage of 200 mg every 3 weeks for up to 6 doses before surgery.
Main Outcomes and Measures


The primary end point was the NAR score. Secondary end points included pathologic complete response (pCR) rate, SSS, disease-free survival, and overall survival. This report focuses on end points available after definitive surgery (NAR score, pCR, SSS, clinical complete response rate, margin involvement, and safety).
Results


A total of 185 patients (126 [68.1%] male; mean [SD] age, 55.7 [11.1] years) were randomized to the control arm (CA) (n = 95) or the pembrolizumab arm (PA) (n = 90). Of these patients, 137 were evaluable for NAR score (68 CA patients and 69 PA patients). The mean (SD) NAR score was 11.53 (12.43) for the PA patients (95% CI, 8.54-14.51) vs 14.08 (13.82) for the CA patients (95% CI, 10.74-17.43) (P = .26). The pCR rate was 31.9% in the PA vs 29.4% in the CA (P = .75). The clinical complete response rate was 13.9% in the PA vs 13.6% in the CA (P = .95). The percentage of patients who underwent SSS was 59.4% in the PA vs 71.0% in the CA (P = .15). Grade 3 to 4 adverse events were slightly increased in the PA (48.2%) vs the CA (37.3%) during chemoradiotherapy. Two deaths occurred during FOLFOX: sepsis (CA) and pneumonia (PA). No differences in radiotherapy fractions, FOLFOX, or capecitabine doses were found.
Conclusions and Relevance


Pembrolizumab added to chemoradiotherapy as part of total neoadjuvant therapy was suggested to be safe; however, the NAR score difference does not support further study.
Trial Registration


ClinicalTrials.gov Identifier: NCT02921256.",2021,Grade 3 to 4 adverse events were slightly increased in the PA (48.2%) vs the CA (37.3%) during chemoradiotherapy.,"['Patients with stage II/III LARC with distal location (cT3-4\u2009≤\u20095 cm from anal verge, any N), with bulky disease (any cT4 or tumor within 3 mm of mesorectal fascia), at high risk for metastatic disease (cN2), and/or who were not candidates for sphincter-sparing surgery (SSS) were stratified based on clinical tumor and nodal stages', 'Locally Advanced Rectal Cancer', 'patients in academic and private practice settings were enrolled', '185 patients (126 [68.1%] male; mean [SD] age, 55.7 [11.1] years']","['neoadjuvant chemoradiotherapy', 'pembrolizumab', 'chemoradiotherapy (capecitabine with 50.4 Gy) with or without intravenous pembrolizumab', 'FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin) and chemoradiotherapy alone', 'pembrolizumab arm (PA', 'neoadjuvant FOLFOX', 'Total neoadjuvant therapy (TNT', 'Total Neoadjuvant Therapy']","['locoregional relapse', 'definitive surgery (NAR score, pCR, SSS, clinical complete response rate, margin involvement, and safety', 'mean (SD', 'clinical complete response rate', 'NAR score', 'Grade 3 to 4 adverse events', 'pathologic complete response (pCR) rate, SSS, disease-free survival, and overall survival', 'neoadjuvant rectal (NAR) score', 'pCR\u2009rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C1175872', 'cui_str': 'CAGE1 protein, human'}, {'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1269794', 'cui_str': 'Status of margin involvement by tumor'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",185.0,0.388095,Grade 3 to 4 adverse events were slightly increased in the PA (48.2%) vs the CA (37.3%) during chemoradiotherapy.,"[{'ForeName': 'Osama E', 'Initials': 'OE', 'LastName': 'Rahma', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Yothers', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Theodore S', 'Initials': 'TS', 'LastName': 'Hong', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Marcia M', 'Initials': 'MM', 'LastName': 'Russell', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Y Nancy', 'Initials': 'YN', 'LastName': 'You', 'Affiliation': 'Department of Surgical Oncology, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Parker', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Jacobs', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Colangelo', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Lucas', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Gollub', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Hall', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kachnic', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Vijayvergia', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': ""O'Rourke"", 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Faller', 'Affiliation': 'Missouri Baptist Medical Center, Heartland Cancer Research, National Cancer Institute Community Oncology Research Program, St Louis.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Valicenti', 'Affiliation': 'Department of Radiation Oncology, UC Davis, Davis, California.'}, {'ForeName': 'Tracey E', 'Initials': 'TE', 'LastName': 'Schefter', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Moxley', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Kainthla', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Stella', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Sigurdson', 'Affiliation': 'Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'George', 'Affiliation': 'NRG Oncology, Philadelphia, Pennsylvania.'}]",JAMA oncology,['10.1001/jamaoncol.2021.1683']
576,34211259,Updates in chemoprevention research for hereditary gastrointestinal and polyposis syndromes.,"Purpose of review


To critically examine recently published research in the area of chemoprevention in hereditary polyposis and gastrointestinal cancers, and to briefly review several ongoing chemoprevention trials testing novel agents in this population.
Recent findings


Four recent chemoprevention trials in patients with familial adenomatous polyposis (FAP) were identified and reviewed. In the FAPEST trial, the combination of erlotinib+sulindac (compared to placebo) met its primary outcome of decreased duodenal polyp burden. A secondary analysis of lower gastrointestinal tract outcomes also demonstrated significant benefits. Two randomized trials in FAP patients examining combination regimens (celecoxib+DFMO and sulindac+DFMO) failed to meet their primary endpoints. Benefits of further research into these combinations was suggested by efficacy signals seen in secondary and post-hoc analyses. Finally, a randomized trial found curcumin (vs placebo) to have no benefit in reducing colorectal polyp count or size in patients with FAP.
Summary


Progress in developing new and more effective preventive options for patients with hereditary gastrointestinal syndromes continues to be made through the efforts of investigators conducting chemoprevention research.",2021,"Finally, a randomized trial found curcumin (vs placebo) to have no benefit in reducing colorectal polyp count or size in patients with FAP.
","['patients with hereditary gastrointestinal syndromes', 'hereditary polyposis and gastrointestinal cancers', 'patients with FAP', 'patients with familial adenomatous polyposis (FAP', 'FAP patients examining']","['curcumin (vs placebo', 'placebo', 'combination regimens (celecoxib+DFMO and sulindac+DFMO']","['colorectal polyp count or size', 'duodenal polyp burden']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0334108', 'cui_str': 'Multiple polyps'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0032580', 'cui_str': 'Adenomatous polyposis coli'}, {'cui': 'C0420616', 'cui_str': 'Patient examined'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0347266', 'cui_str': 'Polyp of duodenum'}]",4.0,0.270904,"Finally, a randomized trial found curcumin (vs placebo) to have no benefit in reducing colorectal polyp count or size in patients with FAP.
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hall', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, USA.'}]",Current treatment options in gastroenterology,['10.1007/s11938-020-00306-x']
577,34217570,Retesting the hypothesis that early Diphtheria-Tetanus-Pertussis vaccination increases female mortality: An observational study within a randomised trial.,"BACKGROUND


There are worrying indications that diphtheria-tetanus-pertussis (DTP) vaccine has negative non-specific effects for females. We previously found, in a trial of early-Bacillus Calmette-Guérin (BCG) to low weight (LW) neonates, that receiving early-DTP (before 2 months of age), was associated with increased female mortality compared with no-DTP/delayed-DTP. Within a subsequent LW trial, we aimed to retest this observation.
METHODS


Between 2010 and 2014, in Guinea-Bissau, 2,398 infants were randomised 1:1 to early-BCG (intervention) or delayed-BCG (standard practice for LW neonates) and visited at 2, 6 and 12 months of age to assess nutritional and vaccination status. DTP is recommended at 6 weeks of age. We examined the effect of having ""early-DTP"" versus ""no-DTP"" at the time of the 2-month visit on all-cause mortality between the 2- and 6-month visits in Cox models stratified by sex and adjusted for BCG-group and 2-month-weight-for-age (z-scores) providing adjusted mortality rate ratios (aMRRs). We analysed to which extent conditions varied between the present and the previous LW trials and how that might have affected the overall result of comparing the early-DTP and the no-DTP groups.
RESULTS


At the time of the 2-month visit, 75% (1,795/2,398) had received DTP. Those vaccinated had better anthropometric indices than no-DTP infants at birth and by 2 months of age. Between the 2- and 6-month visits, 29 deaths occurred. The early-DTP/no-DTP aMRR was 1.09 (95% CI: 0.44-2.69); 1.19 (0.45-3.15) for females and 0.77 (0.14-4.19) for males. Compared to the previous study, the present study cohort had 56% (30-72%) lower overall mortality, fewer no-DTP infants, higher BCG vaccination coverage and several more oral polio vaccine campaigns.
CONCLUSION


We did not find that early-DTP was associated with increased female mortality as found in a previous study; differences in results may partly be due to a decline in overall mortality and changes in vaccination practices.",2022,"Compared to the previous study, the present study cohort had 56% (30-72%) lower overall mortality, fewer no-DTP infants, higher BCG vaccination coverage and several more oral polio vaccine campaigns.
","['Between 2010 and 2014, in Guinea-Bissau, 2,398 infants']","['having ""early-DTP"" versus ""no-DTP', 'Diphtheria-Tetanus-Pertussis vaccination', 'diphtheria-tetanus-pertussis (DTP) vaccine', 'early-BCG (intervention) or delayed-BCG (standard practice for LW neonates) and visited at 2, 6 and 12\xa0months of age to assess nutritional and vaccination status', 'DTP']","['early-DTP/no-DTP aMRR', 'overall mortality', 'anthropometric indices', 'female mortality', 'BCG vaccination coverage', 'mortality rate ratios (aMRRs']","[{'cui': 'C0018387', 'cui_str': 'Guinea-Bissau'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012546', 'cui_str': 'Diphtheria'}, {'cui': 'C0039614', 'cui_str': 'Tetanus'}, {'cui': 'C0031237', 'cui_str': 'Pertussis Vaccine'}, {'cui': 'C0042203', 'cui_str': 'Pertussis vaccination'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1443394', 'cui_str': 'Vaccination status'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012546', 'cui_str': 'Diphtheria'}, {'cui': 'C0039614', 'cui_str': 'Tetanus'}, {'cui': 'C0031237', 'cui_str': 'Pertussis Vaccine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C4505148', 'cui_str': 'Vaccination Coverage'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",2398.0,0.168873,"Compared to the previous study, the present study cohort had 56% (30-72%) lower overall mortality, fewer no-DTP infants, higher BCG vaccination coverage and several more oral polio vaccine campaigns.
","[{'ForeName': 'Marcus Kjær', 'Initials': 'MK', 'LastName': 'Sørensen', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau. Electronic address: marcussorensen93@gmail.com.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Schaltz-Buchholzer', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau; Bandim Health Project, Institute of Clinical Research, Uni. Southern Denmark and Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Andreas Møller', 'Initials': 'AM', 'LastName': 'Jensen', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau; Bandim Health Project, Institute of Clinical Research, Uni. Southern Denmark and Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau; Bandim Health Project, Institute of Clinical Research, Uni. Southern Denmark and Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Monteiro', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Aaby', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}, {'ForeName': 'Christine Stabell', 'Initials': 'CS', 'LastName': 'Benn', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau; Bandim Health Project, Institute of Clinical Research, Uni. Southern Denmark and Odense University Hospital, Odense, Denmark; Danish Institute of Advanced Science, Uni. Southern Denmark, Odense, Denmark. Electronic address: cbenn@health.sdu.dk.'}]",Vaccine,['10.1016/j.vaccine.2021.06.008']
578,34232456,Exercise as a smoking cessation treatment for women: a randomized controlled trial.,"Cigarette smoking remains the leading behavioral risk factor for chronic disease and premature mortality. This RCT tested the efficacy of moderate intensity aerobic exercise as an adjunctive smoking cessation treatment among women. Participants (N = 105; age = 42.5, SD = 11.2) received brief smoking cessation counseling and 10 weeks of nicotine replacement therapy and were randomized to 12 weeks of moderate intensity exercise (Exercise; n = 53) or 12 weeks of health education (Control; n = 52). Longitudinal models, with Generalized Estimating Equations, showed no differences between Exercise and Control in cotinine-verified 7-day point prevalence abstinence (Wald = 1.96, p = 0.10) or continuous abstinence (Wald = 1.45, p = 0.23) at 12-weeks (post-treatment) or 6-, 9-, or 12-month follow-up, controlling for differences in baseline nicotine dependence. There was no effect of exercise on smoking cessation. The present study adds to the literature suggesting null effects of exercise as a smoking cessation adjunctive treatment despite promising findings in short-term laboratory based studies.",2021,"Longitudinal models, with Generalized Estimating Equations, showed no differences between Exercise and Control in cotinine-verified 7-day point prevalence abstinence (Wald = 1.96, p = 0.10) or continuous abstinence (Wald = 1.45, p = 0.23) at 12-weeks (post-treatment) or 6-, 9-, or 12-month follow-up, controlling for differences in baseline nicotine dependence.","['women', 'Participants (N\u2009=\u2009105; age\u2009=\u200942.5, SD\u2009=\u200911.2) received']","['moderate intensity exercise (Exercise; n\u2009=\u200953) or 12\xa0weeks of health education (Control; n\u2009=\u200952', 'brief smoking cessation counseling', 'nicotine replacement therapy', 'Exercise', 'moderate intensity aerobic exercise']","['Exercise and Control in cotinine-verified 7-day point prevalence abstinence', 'smoking cessation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.0346835,"Longitudinal models, with Generalized Estimating Equations, showed no differences between Exercise and Control in cotinine-verified 7-day point prevalence abstinence (Wald = 1.96, p = 0.10) or continuous abstinence (Wald = 1.45, p = 0.23) at 12-weeks (post-treatment) or 6-, 9-, or 12-month follow-up, controlling for differences in baseline nicotine dependence.","[{'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Box G-S121, Providence, RI, 02912, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Emerson', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Box G-S121, Providence, RI, 02912, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ussher', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, UK.""}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Box G-S121, Providence, RI, 02912, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Miranda', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Monti', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Box G-S121, Providence, RI, 02912, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Williams', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Box G-S121, Providence, RI, 02912, USA. david_m_williams@brown.edu.'}]",Journal of behavioral medicine,['10.1007/s10865-021-00236-8']
579,34228099,Immunoguided Discontinuation of Prophylaxis for Cytomegalovirus Disease in Kidney Transplant Recipients Treated with Antithymocyte Globulin: A Randomized Clinical Trial.,"BACKGROUND


Antiviral prophylaxis is recommended in cytomegalovirus (CMV)-seropositive kidney transplant (KT) recipients receiving antithymocyte globulin (ATG) as induction. An alternative strategy of premature discontinuation of prophylaxis after CMV-specific cell-mediated immunity (CMV-CMI) recovery (immunoguided prevention) has not been studied. The aim of this study was to evaluate whether it is effective and safe to discontinue prophylaxis when CMV-CMI is detected and to continue with preemptive therapy.
METHODS


In this open-label, non-inferiority clinical trial, patients were randomized 1:1 to follow immunoguided strategy, receiving prophylaxis (valganciclovir 900 mg daily) until CMV-CMI recovery or to receive fixed-duration prophylaxis until day +90. After prophylaxis, preemptive therapy (valganciclovir 900 mg twice daily) was indicated in both arms until month 6. The primary and secondary outcomes were incidence of CMV disease and replication, respectively, within the first 12 months. Desirability of outcome ranking (DOOR) assessed two deleterious events (CMV disease/replication and neutropenia).
RESULTS


A total of 150 CMV-seropositive KT recipients were randomly assigned. There was no difference in the incidence of CMV disease (0% vs. 2.7%; P = 0.149) and replication (17.1% vs. 13.5%; log-rank test, P = 0.422) between both arms. Incidence of neutropenia was lower in the immunoguided arm (9.2% vs. 37.8%; OR, 6.0; P < 0.001). A total of 66.1% of patients in the immunoguided arm showed a better DOOR, indicating a greater likelihood of a better outcome.
CONCLUSIONS


Prophylaxis can be prematurely discontinued in CMV-seropositive KT patients receiving ATG when CMV-CMI is recovered since no significant increase in the incidence of CMV replication or disease is observed.",2021,"There was no difference in the incidence of CMV disease (0% vs. 2.7%; P = 0.149) and replication (17.1% vs. 13.5%; log-rank test, P = 0.422) between both arms.","['cytomegalovirus (CMV)-seropositive kidney transplant (KT) recipients receiving', 'A total of 150 CMV-seropositive KT recipients', 'Kidney Transplant Recipients Treated with']","['prophylaxis (valganciclovir 900\xa0mg daily) until CMV-CMI recovery or to receive fixed-duration prophylaxis until day +90', 'antithymocyte globulin (ATG', 'Antithymocyte Globulin', 'preemptive therapy (valganciclovir']","['Desirability of outcome ranking (DOOR) assessed two deleterious events (CMV disease/replication and neutropenia', 'Incidence of neutropenia', 'incidence of CMV disease', 'incidence of CMV disease and replication', 'replication']","[{'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0909381', 'cui_str': 'valganciclovir'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0037408', 'cui_str': 'Social Desirability'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0699794', 'cui_str': 'Rank'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0598312', 'cui_str': 'DNA replication'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.0739285,"There was no difference in the incidence of CMV disease (0% vs. 2.7%; P = 0.149) and replication (17.1% vs. 13.5%; log-rank test, P = 0.422) between both arms.","[{'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Páez-Vega', 'Affiliation': 'Maimónides Institute for Biomedical Research of Cordoba (IMIBIC)/Reina Sofía University Hospital/University of Cordoba (UCO), Cordoba, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Gutiérrez-Gutiérrez', 'Affiliation': 'Clinical Unit of Infectious Diseases, Microbiology and Preventive Medicine. Virgen Macarena University Hospital/ University of Seville. Biomedicine Institute of Seville (IBiS), Seville, Spain.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Agüera', 'Affiliation': 'Maimónides Institute for Biomedical Research of Cordoba (IMIBIC)/Reina Sofía University Hospital/University of Cordoba (UCO), Cordoba, Spain.'}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Facundo', 'Affiliation': 'Renal Transplant Unit, Nephrology Service, Fundació Puigvert, Institut Investigació Biosanitaria Sant Pau, Autonomous University of Barcelona (UAB), RedInRen (RD16/0009/0019), Barcelona, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Redondo-Pachón', 'Affiliation': 'Nephrology Service, Hospital del Mar, Hospital del Mar Medical Research Institute (IMIM), RedInRen (RD16/0009/0013), Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Suñer', 'Affiliation': 'Nephrology Service, Virgen del Rocío University Hospital, Seville, Spain.'}, {'ForeName': 'Maria O', 'Initials': 'MO', 'LastName': 'López-Oliva', 'Affiliation': 'Nephrology Service, La Paz University Hospital, RedInRen (RD16/0009/0008), Madrid, Spain.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Yuste', 'Affiliation': 'Infectious Diseases Unit, Clinic University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Montejo', 'Affiliation': 'Infectious Diseases Service, Cruces University Hospital, Bilbao, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Galeano-Álvarez', 'Affiliation': 'Nephrology Service, Ramón y Cajal University Hospital, IRYCIS, RedInRen (RD16/0009/0014), Madrid, Spain.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Ruiz-San Millan', 'Affiliation': 'Nephrology Service, Marqués de Valdecilla Hospital, University of Cantabria, IDIVAL, RedInRen (RD16/0009/0027), Santander, Spain.'}, {'ForeName': 'Ibai', 'Initials': 'I', 'LastName': 'Los-Arcos', 'Affiliation': ""Infectious Diseases Service, Vall d' Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Hernández', 'Affiliation': 'Nephrology Service, Carlos Haya Regional University Hospital, Institute for Biomedical Research of Malaga (IBIMA), Universidad of Malaga, RedInRen (RD16/0009/0006), Malaga, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Fernández-Ruiz', 'Affiliation': 'Infectious Diseases Unit, 12 de Octubre University Hospital, Health Research Institute (imas12), Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Muñoz', 'Affiliation': 'Department of Clinical Microbiology and Infectious Diseases, Gregorio Marañon University Hospital, Madrid, Spain. Gregorio Marañón Biomedical Research Institute, Madrid, Spain. Department of Medicine, Complutense University of Madrid, Madrid, Spain. CIBERES (CB06/06/0058), Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Valle-Arroyo', 'Affiliation': 'Maimónides Institute for Biomedical Research of Cordoba (IMIBIC)/Reina Sofía University Hospital/University of Cordoba (UCO), Cordoba, Spain.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Cano', 'Affiliation': 'Maimónides Institute for Biomedical Research of Cordoba (IMIBIC)/Reina Sofía University Hospital/University of Cordoba (UCO), Cordoba, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Rodríguez-Benot', 'Affiliation': 'Maimónides Institute for Biomedical Research of Cordoba (IMIBIC)/Reina Sofía University Hospital/University of Cordoba (UCO), Cordoba, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Crespo', 'Affiliation': 'Nephrology Service, Hospital del Mar, Hospital del Mar Medical Research Institute (IMIM), RedInRen (RD16/0009/0013), Barcelona, Spain.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Rodelo-Haad', 'Affiliation': 'Maimónides Institute for Biomedical Research of Cordoba (IMIBIC)/Reina Sofía University Hospital/University of Cordoba (UCO), Cordoba, Spain.'}, {'ForeName': 'María A', 'Initials': 'MA', 'LastName': 'Lobo-Acosta', 'Affiliation': 'Clinical Trials Unit, Virgen del Rocio University Hospital (CTU-HUVR), (SCReNPT13/0002/0010-PT17/0017/0012). Seville, Spain.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Garrido-Gracia', 'Affiliation': 'Clinical Trials Unit, Maimonides Institute for Biomedical Research of Cordoba (IMIBIC)/Reina Sofia University Hospital/University of Cordoba (SCReN PT13/0002/0014, PT17/0017/0032), Cordoba, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Vidal', 'Affiliation': 'Maimónides Institute for Biomedical Research of Cordoba (IMIBIC)/Reina Sofía University Hospital/University of Cordoba (UCO), Cordoba, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Guirado', 'Affiliation': 'Renal Transplant Unit, Nephrology Service, Fundació Puigvert, Institut Investigació Biosanitaria Sant Pau, Autonomous University of Barcelona (UAB), RedInRen (RD16/0009/0019), Barcelona, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cantisán', 'Affiliation': 'Maimónides Institute for Biomedical Research of Cordoba (IMIBIC)/Reina Sofía University Hospital/University of Cordoba (UCO), Cordoba, Spain.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Torre-Cisneros', 'Affiliation': 'Maimónides Institute for Biomedical Research of Cordoba (IMIBIC)/Reina Sofía University Hospital/University of Cordoba (UCO), Cordoba, Spain.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciab574']
580,34229074,"Opioid Specific Effects on Central Processing of Sensation and Pain: A Randomized, Cross-Over, Placebo-Controlled Study.","Moderate to severe pain is often treated with opioids, but central mechanisms underlying opioid analgesia are poorly understood. Findings thus far have been contradictory and none could infer opioid specific effects. This placebo-controlled, randomized, 2-way cross-over, double-blinded study aimed to explore opioid specific effects on central processing of external stimuli. Twenty healthy male volunteers were included and 3 sets of assessments were done at each of the 2 visits: 1) baseline, 2) during continuous morphine or placebo intravenous infusion and 3) during simultaneous morphine + naloxone or placebo infusion. Opioid antagonist naloxone was introduced in order to investigate opioid specific effects by observing which morphine effects are reversed by this intervention. Quantitative sensory testing, spinal nociceptive withdrawal reflexes (NWR), spinal electroencephalography (EEG), cortical EEG responses to external stimuli and resting EEG were measured and analyzed. Longer lasting pain (cold-pressor test - hand in 2° water for 2 minutes, tetanic electrical), deeper structure pain (bone pressure) and strong nociceptive (NWR) stimulations were the most sensitive quantitative sensory testing measures of opioid analgesia. In line with this, the principal opioid specific central changes were seen in NWRs, EEG responses to NWRs and cold-pressor EEG. The magnitude of NWRs together with amplitudes and insular source strengths of the corresponding EEG responses were attenuated. The decreases in EEG activity were correlated to subjective unpleasantness scores. Brain activity underlying slow cold-pressor EEG (1-4Hz) was decreased, whereas the brain activity underlying faster EEG (8-12Hz) was increased. These changes were strongly correlated to subjective pain relief. This study points to evidence of opioid specific effects on perception of external stimuli and the underlying central responses. The analgesic response to opioids is likely a synergy of opioids acting at both spinal and supra-spinal levels of the central nervous system. Due to the strong correlations with pain relief, the changes in EEG signals during cold-pressor test have the potential to serve as biomarkers of opioid analgesia. PERSPECTIVE: This exploratory study presents evidence of opioid specific effects on the pain system at peripheral and central levels. The findings give insights into which measures are the most sensitive for assessing opioid-specific effects.",2021,The decreases in EEG activity were correlated to subjective unpleasantness scores.,['Twenty healthy male volunteers'],"['morphine\u202f+\u202fnaloxone or placebo infusion', 'placebo', 'Opioid antagonist naloxone', 'morphine or placebo']","['subjective pain relief', 'Brain activity underlying slow cold-pressor EEG (1-4Hz', 'subjective unpleasantness scores', 'EEG activity', 'Longer lasting pain', 'central processing of sensation and pain', 'central processing of external stimuli', 'Quantitative sensory testing (QST), spinal nociceptive withdrawal reflexes (NWR), spinal electroencephalography (EEG), cortical EEG responses to external stimuli and resting EEG', 'structure pain (bone pressure) and strong nociceptive (NWR) stimulations']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0277847', 'cui_str': 'Flexion spinal defense reflex'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",20.0,0.0474266,The decreases in EEG activity were correlated to subjective unpleasantness scores.,"[{'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Lelic', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark. Electronic address: dl@mech-sense.com.'}, {'ForeName': 'Anne Estrup', 'Initials': 'AE', 'LastName': 'Olesen', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Grønlund', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Fabricio Ariel', 'Initials': 'FA', 'LastName': 'Jure', 'Affiliation': 'Integrative Neuroscience, Center for Sensory-Motor Interaction, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Asbjørn Mohr', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}]",The journal of pain,['10.1016/j.jpain.2021.06.011']
581,34224279,Comparison of Digital Camera Real-Time Display with Conventional Teaching Tube for Slit Lamp Microscopy Teaching.,"PURPOSE


To compare slit-lamp microscopy teaching outcomes with digital camera real-time display and conventional teaching tube in undergraduate education of clinical ophthalmology.
METHODS


Thirty-seven Year 4 medical students were assigned to two groups for slit lamp microscopy teaching with digital camera real-time display (n = 18) and teaching tube (n = 19). The outcome measures included a 5-item questionnaire on their experience and the quality of slit lamp photos taken by the students.
RESULTS


The overall satisfaction score was significantly higher in the group of digital camera real-time display compared with the group of teaching tube (4.5 ± 0.5 vs. 4.2 ± 0.7,  P  = .013). The former group also achieved higher quality score of the slit-lamp photography (4.1 ± 0.3 vs. 3.6 ± 0.5,  P  = .002).
CONCLUSIONS


The digital camera real-time display attachment is more effective in undergraduate ophthalmic education over conventional slit-lamp teaching tube. It is also more favored by students and is thus highly recommended for clinical ophthalmology education.",2022,"The overall satisfaction score was significantly higher in the group of digital camera real-time display compared with the group of teaching tube (4.5 ± 0.5 vs. 4.2 ± 0.7,  P  =0.013).",['Thirty-seven Year 4 medical students'],"['digital camera real-time display with conventional teaching tube for slit lamp microscopy teaching', 'slit lamp microscopy teaching with digital camera real-time display (n=18) and teaching tube', 'digital camera real-time display and conventional teaching tube']","['5-item questionnaire on their experience and the quality of slit lamp photos taken by the students', 'higher quality score', 'overall satisfaction score']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0183355', 'cui_str': 'Slit lamp biomicroscope'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.040733,"The overall satisfaction score was significantly higher in the group of digital camera real-time display compared with the group of teaching tube (4.5 ± 0.5 vs. 4.2 ± 0.7,  P  =0.013).","[{'ForeName': 'Zijing', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong, Shantou, China.'}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong, Shantou, China.'}, {'ForeName': 'Hongxi', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong, Shantou, China.'}, {'ForeName': 'Chi Pui', 'Initials': 'CP', 'LastName': 'Pang', 'Affiliation': 'Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong, Shantou, China.'}, {'ForeName': 'Haoyu', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong, Shantou, China.'}]",Current eye research,['10.1080/02713683.2021.1952606']
582,34228379,Differences in maternal and early child nutritional status by offspring sex in lowland Nepal.,"OBJECTIVE


On average, boys grow faster than girls in early life but appear more susceptible to undernutrition. We investigated sex differences in early child growth, and whether maternal nutritional status and diet differed by offspring sex during and after pregnancy in an undernourished population.
METHODS


We analyzed longitudinal data from a cluster-randomized trial from plains Nepal, stratifying results by child or gestational age. Children's outcomes (0-20 months) were weight, length, and head circumference and their z-scores relative to WHO reference data in 2-monthly intervals (n range: 24837 to 25 946). Maternal outcomes were mid-upper arm circumference (MUAC), and body mass index (BMI) during pregnancy (12-40 weeks) (n = 5550 and n = 5519) and postpartum (n = 15 710 and n = 15 356), and diet in pregnancy. We fitted unadjusted and adjusted mixed-effects linear and logistic regression models comparing boys with girls.
RESULTS


Boys were larger than girls, however relative to their sex-specific reference they had lower length and head circumference z-scores from birth to 12 months, but higher weight-for-length z-scores from 0 to 6 months. Mothers of sons had higher MUAC and BMI around 36 weeks gestation but no other differences in pregnancy diets or pregnancy/postpartum maternal anthropometry were detected. Larger sex differences in children's size in the food supplementation study arm suggest that food restriction in pregnancy may limit fetal growth of boys more than girls.
CONCLUSIONS


Generally, mothers' anthropometry and dietary intake do not differ according to offspring sex. As boys are consistently larger, we expect that poor maternal nutritional status may compromise their growth more than girls. Copyright © 2021 John Wiley & Sons, Ltd.",2022,Mothers of sons had higher MUAC and BMI around 36 weeks gestation but no other differences in pregnancy diets or pregnancy/postpartum maternal anthropometry were detected.,['boys with girls'],['Copyright'],"['MUAC and BMI', 'weight, length, and head circumference and their z-scores relative to WHO reference data', 'pregnancy diets or pregnancy/postpartum maternal anthropometry', 'Maternal outcomes were mid-upper arm circumference (MUAC), and body mass index (BMI']","[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009993', 'cui_str': 'Copyright'}]","[{'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0968211,Mothers of sons had higher MUAC and BMI around 36 weeks gestation but no other differences in pregnancy diets or pregnancy/postpartum maternal anthropometry were detected.,"[{'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Saville', 'Affiliation': 'Institute for Global Health (IGH), University College London (UCL), London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Harris-Fry', 'Affiliation': 'Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Marphatia', 'Affiliation': 'Department of Geography, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Reid', 'Affiliation': 'Department of Geography, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cortina-Borja', 'Affiliation': 'Section of Clinical Epidemiology, Nutrition and Biostatistics, Population Policy and Practice Research and Teaching Department, Great Ormond Street Institute of Child Health (ICH), University College London (UCL), London, UK.'}, {'ForeName': 'Dharma S', 'Initials': 'DS', 'LastName': 'Manandhar', 'Affiliation': 'Mother and Infant Research Activities (MIRA), Kathmandu, Nepal.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Wells', 'Affiliation': 'Section of Clinical Epidemiology, Nutrition and Biostatistics, Population Policy and Practice Research and Teaching Department, Great Ormond Street Institute of Child Health (ICH), University College London (UCL), London, UK.'}]",American journal of human biology : the official journal of the Human Biology Council,['10.1002/ajhb.23637']
583,34228155,"Commentary on ""Methenamine hippurate compared with trimethoprim for the prevention of recurrent urinary tract infections: a randomized clinical trial"".",,2022,,['recurrent urinary tract infections'],['trimethoprim'],[],"[{'cui': 'C0262655', 'cui_str': 'Recurrent urinary tract infection'}]","[{'cui': 'C0041041', 'cui_str': 'Trimethoprim'}]",[],,0.395718,,"[{'ForeName': 'Abdelmageed', 'Initials': 'A', 'LastName': 'Abdelrahman', 'Affiliation': ""Department of Urogynaecology, Liverpool Women's Hospital NHS Foundation Trust, Liverpool, UK. abdelmageed@hotmail.co.uk.""}]",International urogynecology journal,['10.1007/s00192-021-04904-w']
584,34228786,"Comparison of student satisfaction, perceived learning and outcome performance.","OBJECTIVE


The goal of this study was to investigate whether blended online with laboratory instruction differs from traditional classroom lecture and laboratory with regard to student satisfaction and performance in a radiographic technique class teaching radiation health and physics.
METHODS


Following institutional review board approval, 122 participants were randomly assigned to either an online or classroom environment for the lecture portion of the course. All participants attended weekly laboratory sessions in person. Anonymous surveys given during midterm and final exams assessed satisfaction with learning experience and expected grades. Linear models assessing differences between groups were adjusted for age, gender, prior online class experience, online class preference, self-reported computer skill, and time of year.
RESULTS


Students in the blended cohort reported overall greater satisfaction (p < .03) and found the delivery method more enjoyable (p < .002) than did the traditional classroom cohort. No differences in exam scores between groups were observed.
CONCLUSION


This study demonstrated that a blended format of instruction can improve learner satisfaction as compared with the traditional classroom method. Blended instruction implemented into a traditional educational program helps students balance schedules, has a positive impact on perceived learning, and provides exam success similar to that of the traditional classroom.",2022,"RESULTS


Students in the blended cohort reported overall greater satisfaction (p < .03) and found the delivery method more enjoyable (p < .002) than did the traditional classroom cohort.",['122 participants'],['online or classroom environment'],"['overall greater satisfaction', 'learner satisfaction', 'exam scores']",[],"[{'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",122.0,0.0307136,"RESULTS


Students in the blended cohort reported overall greater satisfaction (p < .03) and found the delivery method more enjoyable (p < .002) than did the traditional classroom cohort.","[{'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Taliaferro', 'Affiliation': 'Steven Taliaferro is an assistant professor in the Basic Sciences Department at the University of Western States College of Chiropractic (2900 NE 132nd Avenue, Portland, OR 97230; staliaferro@uws.edu).'}, {'ForeName': 'Beverly L', 'Initials': 'BL', 'LastName': 'Harger', 'Affiliation': 'Beverly Harger is the program director, Diagnostic Imaging, University of Western States (2900 NE 132nd Avenue, Portland, OR 97230; bharger@uws.edu).'}]",The Journal of chiropractic education,['10.7899/JCE-19-33']
585,34236705,"A split-tattoo randomized Q-switched neodymium-doped yttrium-aluminium-garnet laser trial comparing the efficacy of a novel three-pass, one-session method with a conventional method in the treatment of blue/black tattoos in darker skin types.","Tattoos with blue/black ink show good lightening of pigment after treatment with 1064 nm Q-switched (QS) neodymium-doped yttrium-aluminium-garnet (Nd:YAG) laser. In this randomized trial, we compared the efficacy of a novel three pass, one session procedure (R15 method) with a conventional method for treating blue/black tattoos in darker skin types. Tattoos were treated with 1064 nm QS Nd:YAG Laser with a spot size of 4 mm, fluence of 5 J/cm 2  and frequency of 5 Hz. The tattoo pigment lightening was comparable with both methods. Thread-like tattoos had significantly better pigment lightening with fewer side effects than the broad band-like tattoos. We would like to recommend the R15 method of the QS Nd:YAG laser for thread-like tattoos, which can save patients' time, cut short the frequency of their hospital visits and, more importantly, decrease the cost involved in it.",2022,"Tattoos with blue/black ink show good lightening of pigment after treatment with QS Nd-YAG (1064-nm) laser, QS alexandrite (755-nm) laser, or QS ruby (694-nm) laser.[1-3]",['blue/black tattoos in darker skin types'],"['QS Nd-YAG (1064-nm) laser, QS alexandrite (755-nm) laser, or QS ruby (694-nm) laser.[1-3', 'R15 method with conventional regime']",[],"[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0039343', 'cui_str': 'Tattooing'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0675767', 'cui_str': 'alexandrite'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]",[],,0.0403011,"Tattoos with blue/black ink show good lightening of pigment after treatment with QS Nd-YAG (1064-nm) laser, QS alexandrite (755-nm) laser, or QS ruby (694-nm) laser.[1-3]","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Narayanan', 'Affiliation': 'Department of, Dermatology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bhari', 'Affiliation': 'Department of, Dermatology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Sreenivas', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Sharma', 'Affiliation': 'Department of, Dermatology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sethuraman', 'Affiliation': 'Department of, Dermatology, All India Institute of Medical Sciences, New Delhi, India.'}]",Clinical and experimental dermatology,['10.1111/ced.14827']
586,34224858,Mastiha has efficacy in immune-mediated inflammatory diseases through a microRNA-155 Th17 dependent action.,"Mastiha is a natural nutritional supplement with known anti-inflammatory properties. Non-alcoholic fatty liver disease (NAFLD) and Inflammatory bowel disease (IBD) are immune mediated inflammatory diseases that share common pathophysiological features. Mastiha has shown beneficial effects in both diseases. MicroRNAs have emerged as key regulators of inflammation and their modulation by phytochemicals have been extensively studied over the last years. Therefore, the aim of this study was to investigate whether a common route exists in the anti-inflammatory activity of Mastiha, specifically through the regulation of miRNA levels. Plasma miR-16, miR-21 and miR-155 were measured by Real-Time PCR before and after two double blinded and placebo-controlled randomized clinical trials with Mastiha. In IBD and particularly in ulcerative colitis patients in relapse, miR-155 increased in the placebo group (p = 0.054) whereas this increase was prevented by Mastiha. The mean changes were different in the two groups even after adjusting for age, sex and BMI (p = 0.024 for IBD and p = 0.042). Although the results were not so prominent in NAFLD, miR-155 displayed a downward trend in the placebo group (p = 0.054) whereas the levels did not changed significantly in the Mastiha group in patients with less advanced fibrosis. Our results propose a regulatory role for Mastiha in circulating levels of miR-155, a critical player in T helper-17 (Th17) differentiation and function.",2021,"In IBD and particularly in ulcerative colitis patients in relapse, miR-155 increased in the placebo group (p=0.054) whereas this increase was prevented by Mastiha.",[],['placebo'],"['Plasma miR-16, miR-21 and miR-155', 'relapse, miR-155']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.198795,"In IBD and particularly in ulcerative colitis patients in relapse, miR-155 increased in the placebo group (p=0.054) whereas this increase was prevented by Mastiha.","[{'ForeName': 'Charalampia', 'Initials': 'C', 'LastName': 'Amerikanou', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Efstathia', 'Initials': 'E', 'LastName': 'Papada', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Aristea', 'Initials': 'A', 'LastName': 'Gioxari', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Smyrnioudis', 'Affiliation': 'Chios Mastic Gum Growers Association, Chios, Greece.'}, {'ForeName': 'Stamatia-Angeliki', 'Initials': 'SA', 'LastName': 'Kleftaki', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Evdokia', 'Initials': 'E', 'LastName': 'Valsamidou', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Bruns', 'Affiliation': 'Sanofi Research and Development, Industriepark Hoechst, D-65926 Frankfurt, Germany.'}, {'ForeName': 'Rajarshi', 'Initials': 'R', 'LastName': 'Banerjee', 'Affiliation': 'Perspectum Ltd, Oxford, UK.'}, {'ForeName': 'Maria Giovanna', 'Initials': 'MG', 'LastName': 'Trivella', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy; Institute of Clinical Physiology National Research Council, Pisa, Italy.'}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Milic', 'Affiliation': 'Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Medić-Stojanoska', 'Affiliation': 'Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia; Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Centre of Vojvodina, Novi Sad, Serbia.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'Institute of Clinical Physiology National Research Council, Pisa, Italy.'}, {'ForeName': 'Aimo', 'Initials': 'A', 'LastName': 'Kannt', 'Affiliation': 'Sanofi Research and Development, Industriepark Hoechst, D-65926 Frankfurt, Germany; Fraunhofer Institute of Translational Medicine and Pharmacology ITMP, Frankfurt, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'George V', 'Initials': 'GV', 'LastName': 'Dedoussis', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece. Electronic address: dedousi@hua.gr.'}, {'ForeName': 'Andriana C', 'Initials': 'AC', 'LastName': 'Kaliora', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece. Electronic address: akaliora@hua.gr.'}]",Pharmacological research,['10.1016/j.phrs.2021.105753']
587,34224785,Tolerance development in cow's milk-allergic infants receiving amino acid-based formula: A randomized controlled trial.,"BACKGROUND


Tolerance development is an important clinical outcome for infants with cow's milk allergy.
OBJECTIVE


This multicenter, prospective, randomized, double-blind, controlled clinical study (NTR3725) evaluated tolerance development to cow's milk (CM) and safety of an amino acid-based formula (AAF) including synbiotics (AAF-S) comprising prebiotic oligosaccharides (oligofructose, inulin) and probiotic Bifidobacterium breve M-16V in infants with confirmed IgE-mediated CM allergy.
METHODS


Subjects aged ≤13 months with IgE-mediated CM allergy were randomized to receive AAF-S (n = 80) or AAF (n = 89) for 12 months. Stratification was based on CM skin prick test wheal size and study site. After 12 and 24 months, CM tolerance was evaluated by double-blind, placebo-controlled food challenge. A logistic regression model used the all-subjects randomized data set.
RESULTS


At baseline, mean ± SD age was 9.36 ± 2.53 months. At 12 and 24 months, respectively, 49% and 62% of subjects were CM tolerant (AAF-S 45% and 64%; AAF 52% and 59%), and not differ significantly between groups. During the 12-month intervention, the number of subjects reporting at least 1 adverse event did not significantly differ between groups; however, fewer subjects required hospitalization due to serious adverse events categorized as infections in the AAF-S versus AAF group (9% vs 20%; P = .036).
CONCLUSIONS


After 12 and 24 months, CM tolerance was not different between groups and was in line with natural outgrowth. Results suggest that during the intervention, fewer subjects receiving AAF-S required hospitalization due to infections.",2022,"During 12-month intervention, numbers of subjects reporting at least one adverse event did not significantly differ between groups, however fewer subjects required hospitalization due to serious adverse events categorized as infections in AAF-S vs AAF group (9% vs 20%; p=0.036).
","['Subjects ≤13 months with IgE-mediated CMA', ""cow's-milk-allergic infants receiving amino-acid-based formula"", 'Infants with IgE-mediated CMA receiving', ""infants with cow's milk allergy (CMA"", 'infants with confirmed IgE-mediated CMA']","['AAF-S', 'AAF', 'amino-acid-based formula (AAF) including synbiotics (AAF-S) comprising prebiotic-oligosaccharides (oligofructose, inulin) and probiotic Bifidobacterium breve M-16V']","['numbers of subjects reporting at least one adverse event', 'CM tolerance']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0907858', 'cui_str': 'oligofructose'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",,0.175507,"During 12-month intervention, numbers of subjects reporting at least one adverse event did not significantly differ between groups, however fewer subjects required hospitalization due to serious adverse events categorized as infections in AAF-S vs AAF group (9% vs 20%; p=0.036).
","[{'ForeName': 'Pantipa', 'Initials': 'P', 'LastName': 'Chatchatee', 'Affiliation': 'Pediatric Allergy and Clinical Immunology Research Unit, Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nowak-Wegrzyn', 'Affiliation': 'Allergy and Immunology, Department of Pediatrics, New York University Langone Health, New York, NY; Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lange', 'Affiliation': 'St Marien Hospital, Bonn, Germany.'}, {'ForeName': 'Suwat', 'Initials': 'S', 'LastName': 'Benjaponpitak', 'Affiliation': 'Pediatric Allergy and Immunology Division, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kok Wee', 'Initials': 'KW', 'LastName': 'Chong', 'Affiliation': ""Allergy Service, Department of Paediatric Medicine, KK Women's & Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'Pasuree', 'Initials': 'P', 'LastName': 'Sangsupawanich', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand.'}, {'ForeName': 'Marleen T J', 'Initials': 'MTJ', 'LastName': 'van Ampting', 'Affiliation': 'Danone Nutricia Research, Utrecht, The Netherlands. Electronic address: marleen.vanampting@nutricia.com.'}, {'ForeName': 'Manon M', 'Initials': 'MM', 'LastName': 'Oude Nijhuis', 'Affiliation': 'Danone Nutricia Research, Utrecht, The Netherlands.'}, {'ForeName': 'Lucien F', 'Initials': 'LF', 'LastName': 'Harthoorn', 'Affiliation': 'Danone Nutricia Research, Utrecht, The Netherlands.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Langford', 'Affiliation': 'Danone Nutricia Research, Utrecht, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Knol', 'Affiliation': 'Danone Nutricia Research, Utrecht, The Netherlands; Laboratory of Microbiology, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Knipping', 'Affiliation': 'Danone Nutricia Research, Utrecht, The Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Garssen', 'Affiliation': 'Danone Nutricia Research, Utrecht, The Netherlands; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Trendelenburg', 'Affiliation': 'Department of Pediatric Pneumology, Immunology, and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pesek', 'Affiliation': ""Arkansas Children's Hospital, Little Rock, Ark.""}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Davis', 'Affiliation': ""Texas Children's Hospital, Baylor College of Medicine, Houston, Tex.""}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Muraro', 'Affiliation': 'Food Allergy Referral Centre, Padua University Hospital, Padua, Italy.'}, {'ForeName': 'Mich', 'Initials': 'M', 'LastName': 'Erlewyn-Lajeunesse', 'Affiliation': 'University Hospitals Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Fox', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Louise J', 'Initials': 'LJ', 'LastName': 'Michaelis', 'Affiliation': ""Great North Children's Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, United Kingdom.""}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Beyer', 'Affiliation': 'Department of Pediatric Pneumology, Immunology, and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2021.06.025']
588,34233065,Efficacy and safety of glycoprotein IIb/IIIa inhibitors in addition to P2Y 12  inhibitors in ST-segment elevation myocardial infarction: A subanalysis of the POPular Genetics trial.,"BACKGROUND


Glycoprotein IIb/IIIa inhibitors (GPI) are still used in patients with ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI), although discussion about its clinical benefit is ongoing.
METHODS


GPI use was analyzed in this subanalysis of the POPular Genetics trial, which randomized STEMI patients to CYP2C19 genotype-guided treatment (clopidogrel or ticagrelor) or standard treatment with ticagrelor/prasugrel. The composite thrombotic endpoint consisted of cardiovascular death, myocardial infarction (MI), definite stent thrombosis, and stroke at 30 days. The combined bleeding endpoint consisted of Platelet Inhibition and Patient Outcomes (PLATO) major and minor bleeding at 30 days. Univariable and multivariable analyses in addition to a propensity score-matched (PSM) analysis were conducted.
RESULTS


In total, 2378 patients, of whom 1033 received GPI and 1345 did not, were included. In multivariable analysis, GPI administration was associated with fewer thrombotic events (hazard ratio [HR] 0.22, 95% confidence interval [CI] 0.09-0.55) and MIs (HR 0.24, 95% CI 0.08-0.73). Furthermore, GPI administration was associated with an increase in bleedings (HR 2.02, 95% CI 1.27-3.19), driven by minor bleedings (HR 2.32, 95% CI 1.43-3.76), without a significant difference in major bleedings (HR 0.69, 95% CI 0.19-2.57). In the PSM analysis, no significant association was found.
CONCLUSION


In STEMI patients undergoing primary PCI, GPI administration was associated with a reduction in thrombotic events at a cost of an increase in (mostly minor) bleedings in multivariable analysis, while propensity score analysis did not show significant associations.",2022,"In multivariable analysis, GPI administration was associated with fewer thrombotic events (hazard ratio [HR] 0.22, 95% confidence interval [CI] 0.09-0.55) and MIs (HR 0.24, 95% CI 0.08-0.73).","['ST-segment elevation myocardial infarction', '2378 patients, of whom 1033 received GPI and 1345 did not, were included', 'patients with ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI']","['ticagrelor/prasugrel', 'glycoprotein IIb/IIIa inhibitors', 'Glycoprotein IIb/IIIa inhibitors (GPI', 'CYP2C19 genotype-guided treatment (clopidogrel or ticagrelor']","['thrombotic events', 'Platelet Inhibition and Patient Outcomes (PLATO) major and minor bleeding', 'cardiovascular death, myocardial infarction (MI), definite stent thrombosis, and stroke at 30\u2009days', 'major bleedings', 'bleedings']","[{'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016011', 'cui_str': 'Glycoproteins IIb-IIIa'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0016011', 'cui_str': 'Glycoproteins IIb-IIIa'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",2378.0,0.257115,"In multivariable analysis, GPI administration was associated with fewer thrombotic events (hazard ratio [HR] 0.22, 95% confidence interval [CI] 0.09-0.55) and MIs (HR 0.24, 95% CI 0.08-0.73).","[{'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Tavenier', 'Affiliation': 'Department of Cardiology, Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'Daniel M F', 'Initials': 'DMF', 'LastName': 'Claassens', 'Affiliation': 'Department of Cardiology, Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'Department of Cardiology, Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'Gerrit J A', 'Initials': 'GJA', 'LastName': 'Vos', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Thomas O', 'Initials': 'TO', 'LastName': 'Bergmeijer', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Kelder', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Vera H M', 'Initials': 'VHM', 'LastName': 'Deneer', 'Affiliation': 'Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Arnoud W J', 'Initials': 'AWJ', 'LastName': ""van 't Hof"", 'Affiliation': 'Department of Cardiology, Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29861']
589,34224503,"Reading Aloud, Self-Regulation, and Early Language and Cognitive Development in Northern Brazil.","OBJECTIVES


In this study, we examined (1) whether a reading aloud intervention, Universidade do Bebê (UBB), had impacts on self-regulation; (2) whether effects on child outcomes were mediated by self-regulation; and (3) whether effects of UBB were explained through a sequential pathway of impact, including cognitive stimulation in the home, parent-child interactive reading, and self-regulation.
METHODS


We performed a cluster randomized controlled trial of UBB in child care centers serving low-income children (mean age 37.4 months; SD = 6.5) in Northern Brazil. The child care centers were randomized to receive UBB or standard care (control). Families in UBB could borrow children's books weekly and participate in monthly workshops focused on reading aloud. Parent-child dyads (n = 484, intervention = 232, control = 252) were evaluated at baseline and 9 months later on: child self-regulation, vocabulary, intelligence quotient (IQ), working memory, and phonological memory and measures of cognitive stimulation in the home and parent-child interactive reading. Multilevel analyses accounted for baseline performance, sociodemographics, and clustering within centers and sites.
RESULTS


The UBB group showed significantly higher self-regulation (Cohen's d = 0.25), compared with the control group, particularly in the subdomains of Attention (d = 0.24) and Impulse Control (d = 0.21). Previously shown impacts of UBB on receptive vocabulary, IQ, and working memory were mediated by self-regulation. Effects of UBB on self-regulation and child outcomes were partially explained through cognitive stimulation in the home and parent-child interactive reading.
CONCLUSION


Self-regulation represents an important mechanism by which reading aloud interventions affect language and cognitive outcomes. Investigators should consider the role of self-regulation when refining interventions, seeking to prevent poverty-related disparities.",2022,"The UBB group showed significantly higher self-regulation (Cohen's d = 0.25), compared with the control group, particularly in the subdomains of Attention (d = 0.24) and Impulse Control (d = 0.21).","['child care centers', 'Northern Brazil', 'child care centers serving low-income children (mean age 37.4 months; SD = 6.5) in Northern Brazil', 'Parent-child dyads']","['UBB or standard care (control', 'UBB']","['baseline performance, sociodemographics, and clustering within centers and sites', 'child self-regulation, vocabulary, intelligence quotient (IQ), working memory, and phonological memory and measures of cognitive stimulation', 'self-regulation', 'self-regulation and child outcomes', 'receptive vocabulary, IQ, and working memory', 'cognitive stimulation in the home, parent-child interactive reading, and self-regulation', 'Reading Aloud, Self-Regulation, and Early Language and Cognitive Development']","[{'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517741', 'cui_str': '37.4'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",252.0,0.0579374,"The UBB group showed significantly higher self-regulation (Cohen's d = 0.25), compared with the control group, particularly in the subdomains of Attention (d = 0.24) and Impulse Control (d = 0.21).","[{'ForeName': 'Luciane da Rosa', 'Initials': 'LDR', 'LastName': 'Piccolo', 'Affiliation': 'Department of Pediatrics, Division of Developmental-Behavioral Pediatrics, NYU Grossman School of Medicine, New York, NY.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Weisleder', 'Affiliation': 'Roxelyn and Richard Pepper Department of Communication Sciences and Disorders at Northwestern University, Evanston, IL.'}, {'ForeName': 'João B A', 'Initials': 'JBA', 'LastName': 'Oliveira', 'Affiliation': 'Instituto Alfa e Beto, Brasília, Brazil.'}, {'ForeName': 'Denise S R', 'Initials': 'DSR', 'LastName': 'Mazzuchelli', 'Affiliation': 'Instituto Alfa e Beto, Brasília, Brazil.'}, {'ForeName': 'Aline Sá', 'Initials': 'AS', 'LastName': 'Lopez', 'Affiliation': 'Instituto Alfa e Beto, Brasília, Brazil.'}, {'ForeName': 'Walfrido D', 'Initials': 'WD', 'LastName': 'Neto', 'Affiliation': 'Instituto Alfa e Beto, Brasília, Brazil.'}, {'ForeName': 'Carolyn B', 'Initials': 'CB', 'LastName': 'Cates', 'Affiliation': 'Department of Pediatrics, Division of Developmental-Behavioral Pediatrics, NYU Grossman School of Medicine, New York, NY.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'Department of Pediatrics, Division of Developmental-Behavioral Pediatrics, NYU Grossman School of Medicine, New York, NY.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000985']
590,34232458,Seizures and Cognitive Outcome After Traumatic Brain Injury: A Post Hoc Analysis.,"INTRODUCTION


Seizures and abnormal periodic or rhythmic patterns are observed on continuous electroencephalography monitoring (cEEG) in up to half of patients hospitalized with moderate to severe traumatic brain injury (TBI). We aimed to determine the impact of seizures and abnormal periodic or rhythmic patterns on cognitive outcome 3 months following moderate to severe TBI.
METHODS


This was a post hoc analysis of the multicenter randomized controlled phase 2 INTREPID 2566  clinical trial conducted from 2010 to 2016 across 20 United States Level I trauma centers. Patients with nonpenetrating TBI and postresuscitation Glasgow Coma Scale scores 4-12 were included. Bedside cEEG was initiated per protocol on admission to intensive care, and the burden of ictal-interictal continuum (IIC) patterns, including seizures, was quantified. A summary global cognition score at 3 months following injury was used as the primary outcome.
RESULTS


142 patients (age mean + / - standard deviation 32 + / - 13 years; 131 [92%] men) survived with a mean global cognition score of 81 + / - 15; nearly one third were considered to have poor functional outcome. 89 of 142 (63%) patients underwent cEEG, of whom 13 of 89 (15%) had severe IIC patterns. The quantitative burden of IIC patterns correlated inversely with the global cognition score (r =  - 0.57; p = 0.04). In multiple variable analysis, the log-transformed burden of severe IIC patterns was independently associated with the global cognition score after controlling for demographics, premorbid estimated intelligence, injury severity, sedatives, and antiepileptic drugs (odds ratio 0.73, 95% confidence interval 0.60-0.88; p = 0.002).
CONCLUSIONS


The burden of seizures and abnormal periodic or rhythmic patterns was independently associated with worse cognition at 3 months following TBI. Their impact on longer-term cognitive endpoints and the potential benefits of seizure detection and treatment in this population warrant prospective study.",2022,The quantitative burden of IIC patterns correlated inversely with the global cognition score (r =  - 0.57; p = 0.04).,"['Patients with nonpenetrating TBI and postresuscitation Glasgow Coma Scale scores 4-12 were included', 'patients hospitalized with moderate to severe traumatic brain injury (TBI', 'moderate to severe TBI', 'multicenter randomized controlled phase 2 INTREPID 2566  clinical trial conducted from 2010 to 2016 across 20 United States Level I trauma centers', 'After Traumatic Brain Injury', '142 patients (age mean\u2009+\u2009/\u2009-\u2009standard deviation 32\u2009+\u2009/\u2009-\u200913\xa0years; 131 [92%] men) survived with a']",['continuous electroencephalography monitoring (cEEG'],"['global cognition score', 'burden of seizures and abnormal periodic or rhythmic patterns', 'Seizures and Cognitive Outcome', 'mean global cognition score', 'severe IIC patterns']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.177625,The quantitative burden of IIC patterns correlated inversely with the global cognition score (r =  - 0.57; p = 0.04).,"[{'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Foreman', 'Affiliation': 'Department of Neurology & Rehabilitation Medicine, University of Cincinnati Gardner Neuroscience Institute, University of Cincinnati, 231 Albert Sabin Way, Cincinnati, OH, 45267-0517, USA. brandon.foreman@uc.edu.'}, {'ForeName': 'Hyunjo', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology & Rehabilitation Medicine, University of Cincinnati Gardner Neuroscience Institute, University of Cincinnati, 231 Albert Sabin Way, Cincinnati, OH, 45267-0517, USA.'}, {'ForeName': 'Moshe A', 'Initials': 'MA', 'LastName': 'Mizrahi', 'Affiliation': 'Department of Neurology & Rehabilitation Medicine, University of Cincinnati Gardner Neuroscience Institute, University of Cincinnati, 231 Albert Sabin Way, Cincinnati, OH, 45267-0517, USA.'}, {'ForeName': 'Jed A', 'Initials': 'JA', 'LastName': 'Hartings', 'Affiliation': 'Collaborative for Research on Acute Neurological Injuries, University of Cincinnati,, Cincinnati, OH, USA.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Ngwenya', 'Affiliation': 'Department of Neurology & Rehabilitation Medicine, University of Cincinnati Gardner Neuroscience Institute, University of Cincinnati, 231 Albert Sabin Way, Cincinnati, OH, 45267-0517, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Privitera', 'Affiliation': 'Department of Neurology & Rehabilitation Medicine, University of Cincinnati Gardner Neuroscience Institute, University of Cincinnati, 231 Albert Sabin Way, Cincinnati, OH, 45267-0517, USA.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Tortella', 'Affiliation': 'Walter Reed Army Institute of Research, Brain Trauma, Neuroprotection and Neurorestoration Branch, Silver Springs, MD, USA.'}, {'ForeName': 'Nanhua', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': ""Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Joel H', 'Initials': 'JH', 'LastName': 'Kramer', 'Affiliation': 'San Francisco Memory and Aging Center, University of California, San Francisco,, CA, USA.'}]",Neurocritical care,['10.1007/s12028-021-01267-4']
591,34233907,Comparison of volume guarantee and volume-controlled ventilation both using closed loop inspired oxygen in preterm infants: a randomised crossover study (CLIO-VG study).,"OBJECTIVE


The objective of this study was to compare two different modes of ventilation in maintaining oxygen saturation (SpO2) in target range (90%-95%) in ventilated preterm infants cared for with automatic control of oxygen delivery (A-FiO2).
DESIGN


A single-centre randomised crossover study.
SETTINGS


A level III neonatal intensive care unit.
PATIENTS


Preterm infants receiving mechanical ventilation and oxygen requirement >21%.
INTERVENTIONS


Volume guarantee (VG) vs volume controlled ventilation (VCV) modes with automatic oxygen control (A-FiO2).
OUTCOMES


The primary outcome of this study was the proportion of time spent with oxygen saturations in the target range (90%-95%) .
RESULTS


Nineteen preterm infants with a median gestation age 25 weeks (IQR: 24-28) and birth weight 685 g (IQR: 595-980) were enrolled in the study. There was no significant difference in primary outcome of median proportion of time spent in target saturation between the two arms (72% (57-81) in VG vs 75% (58-83) in VCV; p=0.98). There was no significant difference in the secondary outcomes of time spent in SpO2 <80% (0.03% vs 0.14%; p=0.51), time spent in SpO2 >98% (0.50% vs 0.08%; p=0.54), the median FiO2 (31% vs 29%; p=0.51) or manual adjustments carried out between VG and VCV, respectively. The number of episodes of prolonged hypoxaemia and hyperoxaemia were similar in the two groups.
CONCLUSION


There was no significant difference in time spent in target SpO2 range between VG and VCV when A-FiO2 was used as the FiO2 controller in this crossover randomised control study.
TRIAL REGISTRATION NUMBER


NCT03865069.",2022,"There was no significant difference in time spent in target SpO2 range between VG and VCV when A-FiO2 was used as the FiO2 controller in this crossover randomised control study.
","['A level III neonatal intensive care unit', 'preterm infants', 'ventilated preterm infants cared for with automatic control of oxygen delivery (A-FiO2', 'Preterm infants receiving mechanical ventilation and oxygen requirement >21', 'Nineteen preterm infants with a median gestation age 25 weeks (IQR: 24-28) and birth weight 685 g (IQR: 595-980) were enrolled in the study']","['volume guarantee and volume-controlled ventilation both using closed loop inspired oxygen', 'Volume guarantee (VG) vs volume controlled ventilation (VCV) modes with automatic oxygen control (A-FiO2']","['number of episodes of prolonged hypoxaemia and hyperoxaemia', 'median FiO2', 'proportion of time spent with oxygen saturations', 'median proportion of time spent in target saturation', 'time spent in SpO2', 'time spent in target SpO2 range']","[{'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0204796', 'cui_str': 'Special care of premature baby'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C5191367', 'cui_str': '595'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",980.0,0.0970672,"There was no significant difference in time spent in target SpO2 range between VG and VCV when A-FiO2 was used as the FiO2 controller in this crossover randomised control study.
","[{'ForeName': 'Vrinda', 'Initials': 'V', 'LastName': 'Nair', 'Affiliation': 'Neonatal Intensive Care Unit, James Cook University Hospital, Middlesbrough, UK vrinda.nair1@nhs.net.'}, {'ForeName': 'Mithilesh Kumar', 'Initials': 'MK', 'LastName': 'Lal', 'Affiliation': 'Neonatal Intensive Care Unit, James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Gillone', 'Affiliation': 'Neonatal Intensive Care Unit, James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Kannan Loganathan', 'Affiliation': 'Neonatal Intensive Care Unit, James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Thomas Edward', 'Initials': 'TE', 'LastName': 'Bachman', 'Affiliation': 'Medtrx.org, Lake Arrowhead, California, USA.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2021-321712']
592,34240173,The Effect of Erector Spinae Block versus Serratus Plane Block on Pain Scores and Diaphragmatic Excursion in Multiple Rib Fractures. A Prospective Randomized Trial.,"OBJECTIVES


We aimed to investigate whether ultrasound guided erector spinae plane block and serratus anterior plane block would provide effective and safe analgesia in patients with fracture ribs, and to detect their effects on diaphragmatic excursion in such cases.
DESIGN


Prospective double-blind randomized study.
SETTINGS


Tanta University Hospitals.
SUBJECT


Fifty adult patients ASA I, II with fracture ribs.
METHODS


Patients were randomized to receive either ultrasound guided erector spinae block (Group I) or serratus plane block (Group II) with injection of 19 ml bupivacaine 0.25% plus 1 ml dexamethasone (4 mg). Pain scores, 24 hour total analgesic requirements, diaphragmatic excursion and incidence of adverse events were recorded.
RESULTS


At rest and dynamic pain scores were significantly lower in Group I as compared to Group II from 2 hour up to 24 hour post block [median differences (95% CI): -1 (-0.9999; 0.0002), -1 (-0.9999; 0.0002), -1 (-0.9998; 0.0003), -1(-1.000;-0.000) and -1(-2.0000;-1.0000), -1(-0.9998;-0.0001), -1(-1.0001;-1.0002), -1(-2.000; 0.000), respectively], with a significant reduction in 24 hour opioid consumption in Group I in comparison to Group II (P = .004*). Diaphragmatic excursion showed a significant improvement in Group I when compared to Group II at 2, 6, 12, and 24 hour after the block (P = .024*, .038*, .027*, .042* correspondingly). No adverse events were noted.
CONCLUSIONS


Both erector spinae block and serratus plane block provided safe and effective pain relief in traumatic rib fractures. Although the erector spinae group displayed significantly reduced pain scores, decreased analgesic needs and improved diaphragmatic excursion as compared to serratus group, nevertheless, this was of no clinical significance.",2022,At rest and dynamic pain scores were significantly lower in Group I as compared to Group II from 2 hour up to 24 hour post block [median differences (95% CI):,"['Patients', 'Tanta University Hospitals', 'patients with fracture ribs', 'multiple rib fractures', 'traumatic rib fractures', 'Fifty adult patients ASA I, II with fracture ribs']","['ultrasound guided erector spinae block (Group I) or serratus plane block (Group II) with injection of 19\u2009ml bupivacaine 0.25% plus 1', 'ultrasound guided erector spinae plane block and serratus anterior plane block', 'ml dexamethasone', 'erector spinae block versus serratus plane block']","['24h opioid consumption', 'analgesic needs and improved diaphragmatic excursion', 'Pain scores, 24\u2009hour total analgesic requirements, diaphragmatic excursion and incidence of adverse events', 'pain scores and diaphragmatic excursion', 'dynamic pain scores', 'adverse events', 'Diaphragmatic excursion', 'pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0035522', 'cui_str': 'Fracture of rib'}, {'cui': 'C0272567', 'cui_str': 'Fracture of multiple ribs'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0232086', 'cui_str': 'Diaphragmatic excursion'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",50.0,0.079218,At rest and dynamic pain scores were significantly lower in Group I as compared to Group II from 2 hour up to 24 hour post block [median differences (95% CI):,"[{'ForeName': 'Dina Ahmed', 'Initials': 'DA', 'LastName': 'El Malla', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care, and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Rehab Abd El Fattah', 'Initials': 'RAEF', 'LastName': 'Helal', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care, and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Tamer Atef Mohamed', 'Initials': 'TAM', 'LastName': 'Zidan', 'Affiliation': 'Department of Emergency Medicine and Traumatology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mona Blough', 'Initials': 'MB', 'LastName': 'El Mourad', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care, and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnab214']
593,34235822,Enhancing spatial skills of preschoolers from under-resourced backgrounds: A comparison of digital app vs. concrete materials.,"Spatial skills support STEM learning and achievement. However, children from low-socioeconomic (SES) backgrounds typically lag behind their middle- and high-SES peers. We asked whether a digital educational app-designed to mirror an already successful, spatial assembly training program using concrete materials-would be as effective for facilitating spatial skills in under-resourced preschoolers as the concrete materials. Three-year-olds (N = 61) from under-resourced backgrounds were randomly assigned to a business-as-usual control group or to receive 5 weeks of spatial training using either concrete, tangible materials or a digital app on a tablet. The spatial puzzles used were an extension of items from the Test of Spatial Assembly (TOSA). Preschoolers were pretested and posttested on new two-dimensional (2D) TOSA trials. Results indicate that both concrete and digital spatial training increased performance on the 2D-TOSA compared to the control group. The two trainings did not statistically differ from one another suggesting that educational spatial apps may be one route to providing early foundational skills to children from under-resourced backgrounds.",2022,Results indicate that both concrete and digital spatial training increased performance on the 2D-TOSA compared to the control group.,"['Three-year-olds (N\xa0=\xa061) from under-resourced backgrounds', 'preschoolers from under-resourced backgrounds']","['business-as-usual control group or to receive 5 weeks of spatial training using either concrete, tangible materials or a digital app on a tablet', 'digital app vs. concrete materials', 'digital educational app-designed to mirror an already successful, spatial assembly training program']",['performance on the 2D-TOSA'],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}]","[{'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0557857', 'cui_str': 'Concrete'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",[],61.0,0.0154012,Results indicate that both concrete and digital spatial training increased performance on the 2D-TOSA compared to the control group.,"[{'ForeName': 'Corinne A', 'Initials': 'CA', 'LastName': 'Bower', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zimmermann', 'Affiliation': 'School of Education, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Brian N', 'Initials': 'BN', 'LastName': 'Verdine', 'Affiliation': 'School of Education, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Calla', 'Initials': 'C', 'LastName': 'Pritulsky', 'Affiliation': 'School of Education, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Roberta Michnick', 'Initials': 'RM', 'LastName': 'Golinkoff', 'Affiliation': 'School of Education, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Hirsh-Pasek', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, Pennsylvania, USA.'}]",Developmental science,['10.1111/desc.13148']
594,34240656,Efficacy and safety of temelimab in multiple sclerosis: Results of a randomized phase 2b and extension study.,"BACKGROUND


The envelope protein of human endogenous retrovirus W (HERV-W-Env) is expressed by macrophages and microglia, mediating axonal damage in chronic active MS lesions.
OBJECTIVE AND METHODS


This phase 2, double-blind, 48-week trial in relapsing-remitting MS with 48-week extension phase assessed the efficacy and safety of temelimab; a monoclonal antibody neutralizing HERV-W-Env. The primary endpoint was the reduction of cumulative gadolinium-enhancing T1-lesions in brain magnetic resonance imaging (MRI) scans at week 24. Additional endpoints included numbers of T2 and T1-hypointense lesions, magnetization transfer ratio, and brain atrophy. In total, 270 participants were randomized to receive monthly intravenous temelimab (6, 12, or 18 mg/kg) or placebo for 24 weeks; at week 24 placebo-treated participants were re-randomized to treatment groups.
RESULTS


The primary endpoint was not met. At week 48, participants treated with 18 mg/kg temelimab had fewer new T1-hypointense lesions ( p  = 0.014) and showed consistent, however statistically non-significant, reductions in brain atrophy and magnetization transfer ratio decrease, as compared with the placebo/comparator group. These latter two trends were sustained over 96 weeks. No safety issues emerged.
CONCLUSION


Temelimab failed to show an effect on features of acute inflammation but demonstrated preliminary radiological signs of possible anti-neurodegenerative effects. Current data support the development of temelimab for progressive MS.
TRIAL REGISTRATION


CHANGE-MS: ClinicalTrials.gov: NCT02782858, EudraCT: 2015-004059-29; ANGEL-MS: ClinicalTrials.gov: NCT03239860, EudraCT: 2016-004935-18.",2022,"At week 48, participants treated with 18 mg/kg temelimab had fewer new T1-hypointense lesions ( p  = 0.014) and showed consistent, however statistically non-significant, reductions in brain atrophy and magnetization transfer ratio decrease, as compared with the placebo/comparator group.","['multiple sclerosis', '270 participants']","['placebo', 'temelimab', 'intravenous temelimab']","['new T1-hypointense lesions', 'reduction of cumulative gadolinium-enhancing T1-lesions in brain magnetic resonance imaging (MRI) scans', 'brain atrophy and magnetization transfer ratio decrease', 'Efficacy and safety', 'numbers of T2 and T1-hypointense lesions, magnetization transfer ratio, and brain atrophy']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4319603', 'cui_str': '270'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",270.0,0.401651,"At week 48, participants treated with 18 mg/kg temelimab had fewer new T1-hypointense lesions ( p  = 0.014) and showed consistent, however statistically non-significant, reductions in brain atrophy and magnetization transfer ratio decrease, as compared with the placebo/comparator group.","[{'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, Universitätsklinikum Düsseldorf (UKD) and Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany/Center for Neurology and Neuropsychiatry, LVR-Klinikum Düsseldorf, Medical Faculty, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany/Brain and Mind Centre, The University of Sydney, Sydney, NSW, Australia/Department of Neurology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Derfuss', 'Affiliation': 'Department of Neurology, Universitätsspital Basel, Basel, Switzerland.'}, {'ForeName': 'Bruce Ac', 'Initials': 'BA', 'LastName': 'Cree', 'Affiliation': 'Department of Neurology, UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Sormani', 'Affiliation': 'Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy/Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Ospedale Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Selmaj', 'Affiliation': 'Department of Neurology, University of Warmia and Mazury in Olsztyn, Olsztyn, Poland/Department of Neurology, Medical Academy of Łódź, Łódź, Poland.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Stutters', 'Affiliation': 'Nuclear Magnetic Resonance (NMR) Research Unit, Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, UCL Queen Square Institute of Neurology, University College London, London, UK.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Prados', 'Affiliation': 'Nuclear Magnetic Resonance (NMR) Research Unit, Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, UCL Queen Square Institute of Neurology, University College London, London, UK/Centre for Medical Image Computing (CMIC), Department of Medical Physics and Biomedical Engineering, University College London, London, UK; Universitat Oberta de Catalunya, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'MacManus', 'Affiliation': 'Nuclear Magnetic Resonance (NMR) Research Unit, Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, UCL Queen Square Institute of Neurology, University College London, London, UK.'}, {'ForeName': 'Hans-Martin', 'Initials': 'HM', 'LastName': 'Schneble', 'Affiliation': 'Centre for Medical Image Computing (CMIC), Department of Medical Physics and Biomedical Engineering, University College London, London, UK.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Lambert', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Porchet', 'Affiliation': 'GeNeuro SA, Geneva, Switzerland/Department of Pharmacology, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Glanzman', 'Affiliation': 'GeNeuro SA, Geneva, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Warne', 'Affiliation': 'GeNeuro SA, Geneva, Switzerland.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Curtin', 'Affiliation': 'GeNeuro SA, Geneva, Switzerland; Clinical Pharmacology and Toxicology Division, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Kornmann', 'Affiliation': 'GeNeuro SA, Geneva, Switzerland.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Buffet', 'Affiliation': 'GeNeuro SA, Geneva, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kremer', 'Affiliation': 'Department of Neurology, Universitätsklinikum Düsseldorf (UKD) and Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany/Center for Neurology and Neuropsychiatry, LVR-Klinikum Düsseldorf, Medical Faculty, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Küry', 'Affiliation': 'Department of Neurology, Universitätsklinikum Düsseldorf (UKD) and Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany/Center for Neurology and Neuropsychiatry, LVR-Klinikum Düsseldorf, Medical Faculty, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leppert', 'Affiliation': 'Brain and Mind Centre, The University of Sydney, Sydney, NSW, Australia/GeNeuro SA, Geneva, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rückle', 'Affiliation': 'GeNeuro SA, Geneva, Switzerland.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Barkhof', 'Affiliation': 'Nuclear Magnetic Resonance (NMR) Research Unit, Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, UCL Queen Square Institute of Neurology, University College London, London, UK/Centre for Medical Image Computing (CMIC), Department of Medical Physics and Biomedical Engineering, University College London, London, UK/Department of Radiology and Nuclear Medicine, VU University Medical Center Amsterdam, Amsterdam, The Netherlands.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/13524585211024997']
595,34245392,HIT-6 and EQ-5D-5L in patients with migraine: assessment of common latent constructs and development of a mapping algorithm.,"OBJECTIVE


The aims of this study were to assess whether there is a conceptual overlap between the questionnaires HIT-6 and EQ-5D and to develop a mapping algorithm allowing the conversion of HIT-6 to EQ-5D utility scores for Germany.
METHODS


This study used data from an ongoing randomised controlled trial for patients suffering from migraine. We assessed the conceptual overlap between the two instruments with correlation matrices and exploratory factor analysis. Linear regression, tobit, mixture, and two-part models were used for mapping, accounting for repeated measurements, tenfold cross-validation was conducted to validate the models.
RESULTS


We included 1010 observations from 410 patients. The EQ-5D showed a substantial ceiling effect (47.3% had the highest score) but no floor effect, while the HIT-6 showed a very small ceiling effect (0.5%). The correlation between the instruments' total scores was moderate (- 0.30), and low to moderate among each domain (0.021-0.227). The exploratory factor analysis showed insufficient conceptual overlap between the instruments, as they load on different factors. Thus, there is reason to believe that the instruments' domains do not capture the same latent constructs. To facilitate future mapping, we provide coefficients and a variance-covariance matrix for the preferred model, a two-part model with the total HIT-6 score as the explanatory variable.
CONCLUSION


This study showed that the German EQ-5D and the HIT-6 lack the conceptual overlap needed for appropriate mapping. Thus, the estimated mapping algorithms should only be used as a last resort for estimating utilities to be employed in economic evaluations.",2022,"The EQ-5D showed a substantial ceiling effect (47.3% had the highest score) but no floor effect, while the HIT-6 showed a very small ceiling effect (0.5%).","['patients with migraine', 'patients suffering from migraine', '1010 observations from 410 patients']",['HIT-6 and EQ-5D-5L'],['substantial ceiling effect'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}]",1010.0,0.0657839,"The EQ-5D showed a substantial ceiling effect (47.3% had the highest score) but no floor effect, while the HIT-6 showed a very small ceiling effect (0.5%).","[{'ForeName': 'Ana Sofia', 'Initials': 'AS', 'LastName': 'Oliveira Gonçalves', 'Affiliation': 'Institute of Public Health, Charité - Universitätsmedizin, Berlin, Charitépl. 1, 10117, Berlin, Germany. ana.goncalves@charite.de.'}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Panteli', 'Affiliation': 'Department of Health Care Management, Technische Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Neeb', 'Affiliation': 'Department of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kurth', 'Affiliation': 'Institute of Public Health, Charité - Universitätsmedizin, Berlin, Charitépl. 1, 10117, Berlin, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Aigner', 'Affiliation': 'Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-021-01342-9']
596,34242140,Cuff Leak Test and Airway Obstruction in Mechanically Ventilated Intensive Care Unit Patients: A Pilot Randomized Controlled Clinical Trial.,"Rationale:  Laryngeal edema is a known complication of endotracheal intubation that may cause airway obstruction upon extubation. The only test available to predict this complication is the cuff leak test (CLT).  Objectives:  Given the uncertainty of the CLT's clinical utility, we conducted the COMIC ( C uff Leak Test and Airway  O bstruction in  M echanically Ventilated  IC U Patients) pilot study to examine the feasibility of undertaking a larger trial.  Methods:  COMIC is a multicentered, parallel-group randomized trial performed in Canada, Saudi Arabia, and Poland. We enrolled mechanically ventilated adults admitted to the intensive care unit who were deemed ready for extubation. Those allocated to the intervention arm had the results of their CLT communicated to the healthcare team, who then decided to proceed with extubation or not. In those randomized to the control arm, the CLT results were not communicated to the healthcare team and patients were extubated, regardless of the CLT result. The primary outcomes focused on feasibility.  Results:  One hundred patients (56 in the intervention and 44 in the control arm) were enrolled. All feasibility criteria were met, including  1 ) recruitment rate of 7.6 patients/month,  2 ) consent rate of 88.3% (95% confidence interval [CI], 82.1-94.5%), and  3 ) protocol adherence of 98% (95% CI, 95-100%). There were two episodes of clinically significant stridor in the intervention group and four patients who required reintubation in each group.  Conclusions:  The results of the COMIC pilot trial support the feasibility of a larger trial to determine the effect of the CLT on reintubation and clinically important stridor.Clinical trial registered with www.clinicaltrials.gov (NCT03372707).",2022,"There were two episodes of clinically significant stridor in the intervention group, and four patients that required reintubation in each group.
","['Mechanically Ventilated ICU Patients', 'Canada, Saudi Arabia, and Poland', 'Mechanically Ventilated ICU Patients (COMIC', 'enrolled mechanically ventilated adults admitted to the intensive care unit (ICU) who were deemed ready for extubation', 'One hundred patients (56 in the intervention and 44 in the control arm) were enrolled']",['CLT'],"['Cuff Leak Test and Airway Obstruction', 'feasibility']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0001883', 'cui_str': 'Respiratory obstruction'}]",,0.410287,"There were two episodes of clinically significant stridor in the intervention group, and four patients that required reintubation in each group.
","[{'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Culgin', 'Affiliation': ""St. Joseph's Health Research Institute, St. Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Jaeschke', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Perri', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Corry', 'Initials': 'C', 'LastName': 'Marchildon', 'Affiliation': ""St. Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Hassall', 'Affiliation': ""St. Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Almubarak', 'Affiliation': 'Department of Critical Care, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Szczeklik', 'Affiliation': 'Department of Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Piraino', 'Affiliation': ""St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, and.'}, {'ForeName': 'Khaled M', 'Initials': 'KM', 'LastName': 'Alqahtani', 'Affiliation': 'Department of Mathematics, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia; and.'}, {'ForeName': 'Abdulazez', 'Initials': 'A', 'LastName': 'Alghamdi', 'Affiliation': 'Imam Abdulrahman Bin Faisal University Respiratory Therapy Department, King Fahad Hospital of the University, Dammam, Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alshahrani', 'Affiliation': 'Department of Critical Care, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Alhazzani', 'Affiliation': 'Department of Medicine.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202103-390OC']
597,34244154,Economic Evaluation of Web- versus Telephone-based Interventions to Simultaneously Increase Colorectal and Breast Cancer Screening Among Women.,"Screening for colorectal and breast cancer is considered cost effective, but limited evidence exists on cost-effectiveness of screening promotion interventions that simultaneously target both cancers. Increasing Colorectal and Breast Cancer Screening (Project COBRA), a randomized controlled trial conducted in the community, examined the cost-effectiveness of an innovative tailored web-based intervention compared with tailored telephone counseling and usual care. Screening status at 6 months was obtained by participant surveys plus medical record reviews. Cost was prospectively measured from the patient and provider perspectives using time logs and project invoices. Relative efficiency of the interventions was quantified by the incremental cost-effectiveness ratios. Nonparametric bootstrapping and net benefit regression analysis were used to assess statistical uncertainty of the results. The average cost per participant to implement the Phone counseling, Web-based, and Web + Phone counseling interventions were $277, $314, and $337, respectively. Comparing Phone counseling with usual care resulted in an additional cost of $300 (95% confidence interval [CI]: $283-$320) per cancer screening test and $421 (95% CI: $400-$441) per additional person screened in the target population. Phone counseling alone was more cost-effective than the Web + Phone intervention. Web-based intervention alone was more costly but less effective than the Phone counseling. When simultaneously promoting screening for both colorectal and breast cancer the Web-based intervention was less cost-effective compared with Phone and Web + Phone strategies. The results suggest that targeting multiple cancer screening may improve the cost-effectiveness of cancer screening interventions. PREVENTION RELEVANCE: This study informs researchers, decision makers, healthcare providers, and payers about the improved cost-effectiveness of targeting multiple cancer screenings for cancer early detection programs.",2021,When simultaneously promoting screening for both colorectal and breast cancer the Web-based intervention was less cost-effective compared to Phone and Web + Phone strategies.,[],"['Phone counseling alone', 'innovative tailored web-based intervention compared to tailored telephone counseling and usual care']","['cost-effective', 'cost-effectiveness', 'average cost per participant to implement the Phone counseling, Web-based and Web + Phone counseling interventions']",[],"[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0468217,When simultaneously promoting screening for both colorectal and breast cancer the Web-based intervention was less cost-effective compared to Phone and Web + Phone strategies.,"[{'ForeName': 'Danmeng', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'School of Public Health, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lairson', 'Affiliation': 'School of Public Health, The University of Texas Health Science Center at Houston, Houston, Texas. David.R.Lairson@uth.tmc.edu.'}, {'ForeName': 'Tong H', 'Initials': 'TH', 'LastName': 'Chung', 'Affiliation': 'School of Public Health, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Patrick O', 'Initials': 'PO', 'LastName': 'Monahan', 'Affiliation': 'Department of Biostatistics and Health Data Science, Richard M. Fairbanks School of Public Health, School of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Rawl', 'Affiliation': 'School of Nursing, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Champion', 'Affiliation': 'School of Nursing, Indiana University, Indianapolis, Indiana.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-21-0009']
598,34232434,Correction to: RIC in COVID-19-a Clinical Trial to Investigate Whether Remote Ischemic Conditioning (RIC) Can Prevent Deterioration to Critical Care in Patients with COVID-19.,,2021,,['Patients with COVID-19'],['Remote Ischemic Conditioning (RIC'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],,0.172966,,"[{'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Davidson', 'Affiliation': 'The Hatter Cardiovascular Institute, University College, London, 67 Chenies Mews, London, WC1E 6HX, UK.'}, {'ForeName': 'Kishal', 'Initials': 'K', 'LastName': 'Lukhna', 'Affiliation': 'Division of Cardiology, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Diana A', 'Initials': 'DA', 'LastName': 'Gorog', 'Affiliation': 'Postgraduate Medicine, University of Hertfordshire, UK & East and North Hertfordshire NHS Trust, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Salama', 'Affiliation': 'Department of Renal Medicine, Royal Free Hospital, London, UK.'}, {'ForeName': 'Alejandro Rosell', 'Initials': 'AR', 'LastName': 'Castillo', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Giesz', 'Affiliation': 'The Hatter Cardiovascular Institute, University College, London, 67 Chenies Mews, London, WC1E 6HX, UK.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Golforoush', 'Affiliation': 'The Hatter Cardiovascular Institute, University College, London, 67 Chenies Mews, London, WC1E 6HX, UK.'}, {'ForeName': 'Siavash Beikoghli', 'Initials': 'SB', 'LastName': 'Kalkhoran', 'Affiliation': 'The Hatter Cardiovascular Institute, University College, London, 67 Chenies Mews, London, WC1E 6HX, UK.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lecour', 'Affiliation': 'The Hatter Institute for Cardiovascular Research, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Aqeela', 'Initials': 'A', 'LastName': 'Imamdin', 'Affiliation': 'The Hatter Institute for Cardiovascular Research, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Helison R P', 'Initials': 'HRP', 'LastName': 'do Carmo', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Ticiane Gonçalez', 'Initials': 'TG', 'LastName': 'Bovi', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Mauricio W', 'Initials': 'MW', 'LastName': 'Perroud', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Mpiko', 'Initials': 'M', 'LastName': 'Ntsekhe', 'Affiliation': 'Division of Cardiology, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Andrei C', 'Initials': 'AC', 'LastName': 'Sposito', 'Affiliation': 'Atherosclerosis and Vascular Biology Laboratory, State University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Derek M', 'Initials': 'DM', 'LastName': 'Yellon', 'Affiliation': 'The Hatter Cardiovascular Institute, University College, London, 67 Chenies Mews, London, WC1E 6HX, UK. d.yellon@ucl.ac.uk.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-021-07223-w']
599,34252576,A randomized controlled trial to evaluate the safety and efficacy of transluminal injection of foam sclerotherapy compared with ultrasound-guided foam sclerotherapy during endovenous catheter ablation in patients with varicose veins.,"OBJECTIVE


We compared the safety, need for additional foam sclerotherapy, and 1-year venous clinical severity score (VCSS) improvement in the limbs of patients with chronic venous disease and great saphenous vein (GSV) reflux. These patients had undergone endovenous laser ablation (EVLA) using a 1470-nm diode laser and concurrent foam sclerotherapy (1% polidocanol) through the access sheath (transluminal injection of foam sclerotherapy [TLFS]) or EVLA and concurrent direct-puncture ultrasound-guided foam sclerotherapy (UGFS).
METHODS


In the present study, we screened 467 patients (577 legs) with symptomatic primary GSV reflux for randomization to either TLFS with EVLA (n = 103 legs; TLFS group) or UGFS with EVLA (n = 94 legs; UGFS group). The exclusion criteria were (1) recurrent varicose veins after previous intervention; (2) hypersensitivity reaction to sclerotherapy; (3) acute deep vein thrombosis; (4) serious lower limb ischemic disease; (5) a coagulation disorder; and (6) simultaneous EVLA of both GSVs and small saphenous veins. The correlations of the VCSS changes with the clinical features, such as age, sex, CEAP (clinical, etiologic, anatomic, pathophysiologic) classification, total amount of sclerosant used at the original procedure, multiple punctures (more than two) for sclerotherapy at the original procedure, the use of TLFS, and linear endovenous energy density, were estimated using logistic regression.
RESULTS


No significant differences in the distribution of the CEAP classification were observed between the two groups. After 12 months of follow-up, all truncal veins were occluded. The VCSS had significantly improved in the TLFS group compared with the UGFS group (UGFS, -7.4 ± 1.8; TLFS, -8.7 ± 1.5; P < .0001). Multivariate analysis revealed that TLFS was the only significant factor for an improved VCSS (hazard ratio, 0.63; 95% confidence interval, 0.32-0.96; P < .0001). The need for additional second-stage sclerotherapy was significantly avoided in the TLFS group (n = 10; 10%) compared with the UGFS group (n = 51; 54%; P < .0001).
CONCLUSIONS


TLFS combined with EVLA is a safe and feasible procedure that improves the VCSS and reduces the need for additional second-stage interventions compared with UGFS combined with EVLA.",2022,"Additional second-stage sclerotherapy was significantly avoided in the TLFS group [n=10 (10%)] compared to the UGFS group [n=51 (54%); p<.0001].
","['patients with varicose veins', 'Exclusion criteria were (1) recurrent varicose veins after a previous intervention, (2) hypersensitivity reaction to sclerotherapy, (3) acute deep vein thrombosis, (4) serious lower-limb ischemic disease, (5) coagulation disorder, and (6) simultaneous EVLA of both GSV and small saphenous veins', '467 patients (577 legs) with symptomatic primary GSV reflux for randomization to either TLFS with EVLA (103 legs; TLFS group) or UGFS with EVLA (94 legs; UGFS group', 'limbs of chronic venous disease patients with great saphenous vein (GSV) reflux treated with']","['TLFS', 'TLFS combined with EVLA', 'transluminal injection of foam sclerotherapy', 'EVLA and concurrent direct-puncture ultrasound-guided foam sclerotherapy (UGFS', 'sheath [transluminal injection of foam sclerotherapy (TLFS', 'UGFS', 'endovenous laser ablation (EVLA; 1470 nm diode laser) and concurrent foam sclerotherapy (1% polidocanol', 'ultrasound-guided foam sclerotherapy', 'endovenous catheter ablation']","['safety and efficacy', 'VCSS', 'distribution of CEAP classification']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0226827', 'cui_str': 'Structure of small saphenous vein'}, {'cui': 'C4517784', 'cui_str': '467'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0522520', 'cui_str': 'Transluminal approach'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0522520', 'cui_str': 'Transluminal approach'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0071330', 'cui_str': 'polidocanol'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]",467.0,0.108352,"Additional second-stage sclerotherapy was significantly avoided in the TLFS group [n=10 (10%)] compared to the UGFS group [n=51 (54%); p<.0001].
","[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Watanabe', 'Affiliation': 'Cardiovascular Center, Sakurabashi Watanabe Hospital, Osaka, Japan. Electronic address: sa_watanabe@watanabe-hsp.or.jp.'}, {'ForeName': 'Atsunori', 'Initials': 'A', 'LastName': 'Okamura', 'Affiliation': 'Cardiovascular Center, Sakurabashi Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Mutsumi', 'Initials': 'M', 'LastName': 'Iwamoto', 'Affiliation': 'Cardiovascular Center, Sakurabashi Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Nagai', 'Affiliation': 'Cardiovascular Center, Sakurabashi Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Sumiyoshi', 'Affiliation': 'Cardiovascular Center, Sakurabashi Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Cardiovascular Center, Sakurabashi Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Cardiovascular Center, Sakurabashi Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Cardiovascular Center, Sakurabashi Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Katsuomi', 'Initials': 'K', 'LastName': 'Iwakura', 'Affiliation': 'Cardiovascular Center, Sakurabashi Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Fujii', 'Affiliation': 'Cardiovascular Center, Sakurabashi Watanabe Hospital, Osaka, Japan.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2021.06.017']
600,34247893,Efficacy of a novel walking assist device with auxiliary laser illuminator in stroke Patients~ a randomized control trial.,"BACKGROUND/PURPOSE


Task-oriented functional walking is important in stroke patients. We aimed to investigate effects of a quad-cane with auxiliary laser illuminator (laser-cane) among stroke patients.
METHODS


This was a randomized-prospective study. Patients in the experimental group (EG) received 15-min of walking training with laser-cane and 15-min of traditional physical therapy. Patients in the control group (CG) received the same rehabilitation without laser-cane. The rehabilitation lasted for 4 weeks, twice per week. Primary outcome were gait parameters. Secondary outcomes were Berg Balance Scale (BBS), Timed Up and Go Test (TUG), and Barthel index (BI). Outcomes were measured at baseline, at the end of the rehabilitation (visit-1), and 4 weeks later (visit-2).
RESULTS


Both the groups (both n = 15) showed improvement of cadence, relative stance and swing phase duration of non-paretic side, BBS, and TUG at both visits. In the intragroup comparison, the EG additionally improved at stride length, relative stance and swing phase duration of paretic side, and gait speed at both visits; temporal swing symmetry, and toe-off angle of non-paretic side at the visit-2. Intergroup comparing for changing of outcomes with the CG, stride length and gait speed increased, relative stance phase duration of the non-paretic site decreased, and the temporal swing symmetry improved at the visit-1; relative stance phase duration of the paretic side decreased and the temporal stance symmetry improved at the visit-2 in the EG.
CONCLUSION


Rehabilitation with laser-cane improved the balance, activity of daily living, gait symmetry and gait parameters of stroke patients.",2022,"In the intragroup comparison, the EG additionally improved at stride length, relative stance and swing phase duration of paretic side, and gait speed at both visits; temporal swing symmetry, and toe-off angle of non-paretic side at the visit-2.",['stroke patients'],"['walking training with laser-cane and 15-min of traditional physical therapy', 'quad-cane with auxiliary laser illuminator (laser-cane', 'novel walking assist device with auxiliary laser illuminator', 'same rehabilitation without laser-cane']","['temporal swing symmetry', 'Berg Balance Scale (BBS), Timed Up and Go Test (TUG), and Barthel index (BI', 'stride length, relative stance and swing phase duration of paretic side, and gait speed at both visits; temporal swing symmetry, and toe-off angle of non-paretic side at the visit-2', 'stride length and gait speed increased, relative stance phase duration of the non-paretic site', 'gait parameters', 'temporal stance symmetry', 'balance, activity of daily living, gait symmetry and gait parameters', 'improvement of cadence, relative stance and swing phase duration of non-paretic side, BBS, and TUG at both visits']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0006856', 'cui_str': 'Cane'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C4042790', 'cui_str': 'Quad'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.0271888,"In the intragroup comparison, the EG additionally improved at stride length, relative stance and swing phase duration of paretic side, and gait speed at both visits; temporal swing symmetry, and toe-off angle of non-paretic side at the visit-2.","[{'ForeName': 'Wan-Yun', 'Initials': 'WY', 'LastName': 'Huang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Institute of Allied Health Sciences, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Sheng-Hui', 'Initials': 'SH', 'LastName': 'Tuan', 'Affiliation': 'Department of Rehabilitation Medicine, Cishan Hospital, Ministry of Health and Welfare, Kaohsiung, Taiwan; Department of Physical Therapy, Shu-Zen Junior College of Medicine and Management, Kaohsiung, Taiwan.'}, {'ForeName': 'Min-Hui', 'Initials': 'MH', 'LastName': 'Li', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. Electronic address: mhli@vghks.gov.tw.'}, {'ForeName': 'Pei-Te', 'Initials': 'PT', 'LastName': 'Hsu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. Electronic address: peitehsu@gmail.com.'}]",Journal of the Formosan Medical Association = Taiwan yi zhi,['10.1016/j.jfma.2021.06.019']
601,34255325,Acute Effects of Parallel Back Squat Performed in Different Set Configurations on Neuromuscular Performance.,"We compared the acute effects of parallel back squat performed from different resistance training configurations on neuromuscular performance. Twenty-eight young adults underwent 4 experimental conditions: inter-repetition rest, traditional, traditional to failure, and rest-pause in the parallel back squat in a randomized, counterbalanced, and cross-over design. The neuromuscular performance was assessed through peak torque of knee extensors and flexors at two angular velocities (90 and 120 º/s) in three moments (before, post, and post-30 min). The peak torque of the knee extensors and flexors at 90 and 120 º/s decreased immediately after training for traditional, traditional to failure, and rest-pause (-8.1% to -17.7%,  P <0.001). A greater reduction in the extensor peak torque was found at 120 º/s ( P <0.05) in the rest-pause (-17.7%) when compared to traditional (-10.8%). The peak torque returned to baseline values only at post-30 min for the traditional configuration for the knee flexion action at 120 º/s. The peak torque remained similar for the muscular actions and angular velocities for the inter-repetition rest ( P >0.05). Our results suggest the inter-repetition rest configuration seems to be a more appropriate strategy for maintaining the lower limb neuromuscular performance after a resistance training session.",2022,"The peak torque of the knee extensors and flexors at 90 and 120 º/s decreased immediately after training for traditional, traditional to failure, and rest-pause (-8.1% to -17.7%,  P <0.001).",['Twenty-eight young adults underwent'],"['Parallel Back Squat', '4 experimental conditions: inter-repetition rest, traditional, traditional to failure, and rest-pause in the parallel back squat', 'parallel back squat performed from different resistance training configurations']","['extensor peak torque', 'peak torque of knee extensors and flexors at two angular velocities', 'peak torque of the knee extensors and flexors', 'muscular actions and angular velocities', 'Neuromuscular Performance', 'peak torque', 'neuromuscular performance']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0441472', 'cui_str': 'Action'}]",28.0,0.0373224,"The peak torque of the knee extensors and flexors at 90 and 120 º/s decreased immediately after training for traditional, traditional to failure, and rest-pause (-8.1% to -17.7%,  P <0.001).","[{'ForeName': 'Witalo', 'Initials': 'W', 'LastName': 'Kassiano', 'Affiliation': 'GEPEMENE-Metabolism, Nutrition and Exercise Laboratory, State University of Londrina, Londrina, Brazil.'}, {'ForeName': 'Manoel', 'Initials': 'M', 'LastName': 'da Cunha Costa', 'Affiliation': 'Human Performance Laboratory, State of University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Fabiano', 'Initials': 'F', 'LastName': 'de Souza Fonseca', 'Affiliation': 'Department of Physical Education, Federal Rural University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Dalton', 'Initials': 'D', 'LastName': 'de Lima-Júnior', 'Affiliation': 'Department of Physical Education, Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Costa', 'Affiliation': 'GEPEMENE-Metabolism, Nutrition and Exercise Laboratory, State University of Londrina, Londrina, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'de Sousa Fortes', 'Affiliation': 'Department of Physical Education, Federal University of Paraíba, João Pessoa, Brazil.'}]",International journal of sports medicine,['10.1055/a-1518-7537']
602,34254405,"Neurophysiological and clinical effects of the NMDA receptor antagonist lanicemine (BHV-5500) in PTSD: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Posttraumatic stress disorder (PTSD) is associated with hyperarousal and stress reactivity, features consistent with behavioral sensitization. In this Phase 1b, parallel-arm, randomized, double-blind, placebo-controlled trial, we tested whether the selective low-trapping N-methyl-D-aspartate receptor (NMDAR) antagonist [Lanicemine (BHV-5500)] blocks expression of behavioral sensitization.
METHODS


Twenty-four participants with elevated anxiety potentiated startle (APS) and moderate-to-severe PTSD symptoms received three infusions of lanicemine 1.0 mg/ml (100 mg) or matching placebo (0.9% saline) (1:1 ratio), over a 5-day period. The primary outcome was change in APS from baseline to end of third infusion. We also examined changes in EEG gamma-band oscillatory activity as measures of NMDAR target engagement and explored Clinician-Administered PTSD Scale (CAPS-5) hyperarousal scores.
RESULTS


Lanicemine was safe and well-tolerated with no serious adverse events. Using Bayesian statistical inference, the posterior probability that lanicemine outperformed placebo on APS T-score after three infusions was 38%. However, after the first infusion, there was a 90% chance that lanicemine outperformed placebo in attenuating APS T-score by a standardized effect size more than 0.4.
CONCLUSION


We demonstrated successful occupancy of lanicemine on NMDAR using gamma-band EEG and effects on hyperarousal symptoms (Cohen's d = 0.75). While lanicemine strongly attenuated APS following a single infusion, differential changes from placebo after three infusions was likely obscured by habituation effects. To our knowledge, this is the first use of APS in the context of an experimental medicine trial of a NMDAR antagonist in PTSD. These findings support selective NMDAR antagonism as a viable pharmacological strategy for salient aspects of PTSD.",2021,"Using Bayesian statistical inference, the posterior probability that lanicemine outperformed placebo on APS T-score after three infusions was 38%.","['PTSD', 'Posttraumatic stress disorder (PTSD', 'Twenty-four participants with elevated anxiety potentiated startle (APS) and moderate-to-severe PTSD symptoms']","['placebo', 'NMDA receptor antagonist lanicemine (BHV-5500', 'lanicemine 1.0\u2009mg/ml (100\u2009mg) or matching placebo', 'selective low-trapping N-methyl-D-aspartate receptor (NMDAR) antagonist [Lanicemine (BHV-5500']","['change in APS', 'APS T-score', 'EEG gamma-band oscillatory activity as measures of NMDAR target engagement and explored Clinician-Administered PTSD Scale (CAPS-5) hyperarousal scores', 'hyperarousal symptoms', 'safe and well-tolerated with no serious adverse events']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",24.0,0.574909,"Using Bayesian statistical inference, the posterior probability that lanicemine outperformed placebo on APS T-score after three infusions was 38%.","[{'ForeName': 'Nithya', 'Initials': 'N', 'LastName': 'Ramakrishnan', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Mood and Anxiety Disorders Program, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Marijn', 'Initials': 'M', 'LastName': 'Lijffijt', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Mood and Anxiety Disorders Program, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Green', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, University of Texas, Houston, Texas, USA.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Balderston', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Murphy', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Mood and Anxiety Disorders Program, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'Intramural Research Program, NIMH, Bethesda, Maryland, USA.'}, {'ForeName': 'Tabish', 'Initials': 'T', 'LastName': 'Iqbal', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Mood and Anxiety Disorders Program, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Vo-Le', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Mood and Anxiety Disorders Program, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': ""O'Brien"", 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Mood and Anxiety Disorders Program, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Murrough', 'Affiliation': 'Department of Psychiatry, Department of Neuroscience, Depression and Anxiety Center for Discovery and Treatment, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Swann', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Mood and Anxiety Disorders Program, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Mood and Anxiety Disorders Program, Baylor College of Medicine, Houston, Texas, USA.'}]",Depression and anxiety,['10.1002/da.23194']
603,34254673,Long-term safety of adjunctive cenobamate in patients with uncontrolled focal seizures: Open-label extension of a randomized clinical study.,"OBJECTIVE


This study was undertaken to examine long-term (up to 7.8 years) retention rate, safety, and tolerability of the antiseizure medication (ASM) cenobamate as adjunctive treatment in the open-label extension (OLE) of study YKP3089C013 (C013; ClinicalTrials.gov: NCT01397968).
METHODS


Patients who completed the 12-week, multicenter, multinational, double-blind, randomized, placebo-controlled C013 study, which examined adjunctive cenobamate treatment of adults with uncontrolled focal seizures, were eligible to enroll in the OLE. During the OLE, dose adjustments of cenobamate and concomitant ASMs were allowed. Safety assessments included frequency of treatment-emergent adverse events (TEAEs) and serious TEAEs, TEAE severity, and TEAEs leading to discontinuation. Probability of patient continuation in the OLE was examined using a Kaplan-Meier analysis.
RESULTS


One hundred forty-nine patients entered the OLE (median duration of cenobamate treatment = 6.25 years). As of the data cutoff, 57% of patients (85/149) remained in the OLE (median treatment duration = 6.8 years, range = 6.4-7.8 years). The median modal daily cenobamate dose was 200 mg (range = 50-400 mg). The probability of treatment continuation at 1-6 years of cenobamate treatment was 73%, 67%, 63%, 61%, 60%, and 59%, respectively. Among patients who continued at 1 year (n = 107), the probability of continuing at Years 2-5 was 92%, 87%, 83%, and 82%. The most common discontinuation reasons were patient withdrawal (19.5%, 29/149), adverse event (10.1%, 15/149), and lack of efficacy (5.4%, 8/149). TEAEs leading to discontinuation in 1% or more of patients were fatigue (1.3%, 2/149), ataxia (1.3%, 2/149), and memory impairment or amnesia (1.3%, 2/149). Dizziness (32.9%, 49/149), headache (26.8%, 40/149), and somnolence (21.5%, 32/149) were the most frequently reported TEAEs and were primarily mild or moderate in severity.
SIGNIFICANCE


Long-term retention in the C013 OLE study demonstrated sustained safety and tolerability of adjunctive cenobamate treatment up to 7.8 years in adults with treatment-resistant focal seizures taking one to three ASMs.",2021,"The most common discontinuation reasons were patient withdrawal (19.5%, 29/149), adverse event (10.1%, 15/149), and lack of efficacy (5.4%, 8/149).","['adults with uncontrolled focal seizures, were eligible to enroll in the OLE', 'Patients who completed the 12-week, multicenter, multinational', 'One hundred forty-nine patients entered the', 'adults with treatment-resistant focal seizures taking one to three ASMs', 'patients with uncontrolled focal seizures']","['adjunctive cenobamate', 'placebo', 'antiseizure medication (ASM) cenobamate', 'OLE']","['memory impairment or amnesia', 'frequency of treatment-emergent adverse events (TEAEs) and serious TEAEs, TEAE severity, and TEAEs leading to discontinuation', 'ataxia', 'sustained safety and tolerability', 'retention rate, safety, and tolerability', 'fatigue', 'lack of efficacy', 'Dizziness', 'headache', 'adverse event', 'somnolence', 'probability of continuing', 'probability of treatment continuation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0242536', 'cui_str': 'Eastern Samoa'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0233794', 'cui_str': 'Memory impairment'}, {'cui': 'C0002622', 'cui_str': 'Amnesia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",,0.173802,"The most common discontinuation reasons were patient withdrawal (19.5%, 29/149), adverse event (10.1%, 15/149), and lack of efficacy (5.4%, 8/149).","[{'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'French', 'Affiliation': 'New York University Langone Comprehensive Epilepsy Center, New York, New York, USA.'}, {'ForeName': 'Steve S', 'Initials': 'SS', 'LastName': 'Chung', 'Affiliation': 'Neuroscience Institute, Banner-University Medical Center, University of Arizona, Phoenix, Arizona, USA.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Krauss', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Sang Kun', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Adult Comprehensive Epilepsy Center, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Maciejowski', 'Affiliation': 'NZOZ Diagnomed Clinical Research, Katowice, Poland.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Rosenfeld', 'Affiliation': 'Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, Missouri, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Sperling', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kamin', 'Affiliation': 'SK Life Science, Paramus, New Jersey, USA.'}]",Epilepsia,['10.1111/epi.17007']
604,34394896,Computed Tomography Image Segmentation Algorithm to Detect the Curative Effect of Radial Shock Wave Therapy for Knee Osteoarthritis.,"The aim of this study was to investigate the values of computed tomography (CT) imaging technology based on image segmentation algorithm (ISA). It was applied in the radial shock wave therapy (RSWT) to treat knee osteoarthritis (KOA), so its curative effect and rehabilitation effect on nerve function were mainly analyzed in this study. 84 patients with KOA were selected and grouped into an ultrasonic treatment group (group A) and a RSW group (group B). All the patients received the ISA-based CT examination and high-quality nursing intervention. There were comparisons on the effects of pain improvement, knee joint function, and nerve function rehabilitation of patients in groups A and B. Results showed that visual analogue scale (VAS) scores before and after treatment were markedly different among all patients, and the pain degree of patients in group B was lower than the degree of group A ( P  < 0.05). The knee joint function of group B after treatment was greatly better than group A ( P  < 0.05). Scandinavian stroke scale (SSS) scores of nerve function rehabilitation after nursing in patients from group B were sharply lower than the scores of group A ( P  < 0.05). Results indicated that ISA-based CT images could be applied in analysis of curative effect on KOA, and there was more obvious effect of RSWT in the treatment of KOA.",2021,The knee joint function of group B after treatment was greatly better than group A ( P  < 0.05).,"['Knee Osteoarthritis', '84 patients with KOA']","['computed tomography (CT) imaging technology', 'radial shock wave therapy (RSWT', 'Radial Shock Wave Therapy', 'RSW', 'Computed Tomography Image Segmentation Algorithm']","['Scandinavian stroke scale (SSS) scores of nerve function rehabilitation', 'pain degree', 'pain improvement, knee joint function, and nerve function rehabilitation', 'knee joint function', 'visual analogue scale (VAS) scores']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0441635', 'cui_str': 'Segment'}]","[{'cui': 'C0240951', 'cui_str': 'Scandinavian'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",84.0,0.0141448,The knee joint function of group B after treatment was greatly better than group A ( P  < 0.05).,"[{'ForeName': 'Jinghai', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Department of Orthopedics, People's Hospital of Dongxihu District, Wuhan 430030, Hubei, China.""}, {'ForeName': 'Guoyong', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, Wuhan Asia Heart General Hospital, Wuhan 430000, Hubei, China.'}, {'ForeName': 'Fuhong', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': 'Department of Orthopedics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, Hubei, China.'}, {'ForeName': 'Guotang', 'Initials': 'G', 'LastName': 'Lan', 'Affiliation': ""Department of Orthopedics, People's Hospital of Dongxihu District, Wuhan 430030, Hubei, China.""}]",Journal of healthcare engineering,['10.1155/2021/7098924']
605,34258889,Changes in mood and health-related quality of life in Look AHEAD 6 years after termination of the lifestyle intervention.,"OBJECTIVE


The Action for Health in Diabetes (Look AHEAD) study previously reported that intensive lifestyle intervention (ILI) reduced incident depressive symptoms and improved health-related quality of life (HRQOL) over nearly 10 years of intervention compared with a control group (the diabetes support and education group [DSE]) in participants with type 2 diabetes and overweight or obesity. The present study compared incident depressive symptoms and changes in HRQOL in these groups for an additional 6 years following termination of the ILI in September 2012.
METHODS


A total of 1,945 ILI participants and 1,900 DSE participants completed at least one of four planned postintervention assessments at which weight, mood (via the Patient Health Questionnaire-9), antidepressant medication use, and HRQOL (via the Medical Outcomes Scale, Short Form-36) were measured.
RESULTS


ILI participants and DSE participants lost 3.1 (0.3) and 3.8 (0.3) kg [represented as mean (SE); p = 0.10], respectively, during the 6-year postintervention follow-up. No significant differences were observed between groups during this time in incident mild or greater symptoms of depression, antidepressant medication use, or in changes on the physical component summary or mental component summary scores of the Short Form-36. In both groups, mental component summary scores were higher than physical component summary scores.
CONCLUSIONS


Prior participation in the ILI, compared with the DSE group, did not appear to improve subsequent mood or HRQOL during 6 years of postintervention follow-up.",2021,"No significant differences were observed between groups during this time in incident mild or greater symptoms of depression, antidepressant medication use, or in changes on the physical component summary or mental component summary scores of the Short Form-36.","['participants with type 2 diabetes and overweight or obesity', '1,945 ILI participants and 1,900 DSE participants completed at least one of four planned postintervention assessments at which', 'Diabetes']","['control group (the diabetes support and education group [DSE', 'intensive lifestyle intervention (ILI', 'DSE']","['subsequent mood or HRQOL', 'symptoms of depression, antidepressant medication use, or in changes on the physical component summary or mental component summary scores of the Short Form-36', 'incident depressive symptoms and improved health-related quality of life (HRQOL', 'weight, mood (via the Patient Health Questionnaire-9), antidepressant medication use, and HRQOL (via the Medical Outcomes Scale, Short Form-36', 'mood and health-related quality of life', 'incident depressive symptoms and changes in HRQOL']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0525726,"No significant differences were observed between groups during this time in incident mild or greater symptoms of depression, antidepressant medication use, or in changes on the physical component summary or mental component summary scores of the Short Form-36.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Harelda', 'Initials': 'H', 'LastName': 'Anderson', 'Affiliation': 'Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona, and Shiprock, New Mexico, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Annis', 'Affiliation': 'Department of Psychiatry, the Miriam Hospital, Alpert Medical School, Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Atkinson', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, VA Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Bolin', 'Affiliation': 'Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona, and Shiprock, New Mexico, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Brantley', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Dutton', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Foreyt', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'W Gregg', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Helen P', 'Initials': 'HP', 'LastName': 'Hazuda', 'Affiliation': 'Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Van S', 'Initials': 'VS', 'LastName': 'Hubbard', 'Affiliation': 'Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Department of Health and Physical Activity, School of Education, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Jeffery', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Twin Cities, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Departments of Preventive Medicine and Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, VA Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona, and Shiprock, New Mexico, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Korytkowski', 'Affiliation': 'Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Blandine', 'Initials': 'B', 'LastName': 'Laferrère', 'Affiliation': 'Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Roeland J', 'Initials': 'RJ', 'LastName': 'Middelbeek', 'Affiliation': 'Joslin Diabetes Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Medha N', 'Initials': 'MN', 'LastName': 'Munshi', 'Affiliation': 'Joslin Diabetes Center, Boston, Massachusetts, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Nathan', 'Affiliation': 'Diabetes Center, Massachusetts General Hospital, Harvard Medical School, Harvard University, Boston, Massachusetts, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Biostatistics and Data Science, School of Medicine, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Pilla', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Jack W', 'Initials': 'JW', 'LastName': 'Rejeski', 'Affiliation': 'Department of Health and Exercise Sciences, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Redmon', 'Affiliation': 'Department of Medicine, University of Minnesota Medical School, Twin Cities, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Stewart', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Vaughan', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Lynne E', 'Initials': 'LE', 'LastName': 'Wagenknecht', 'Affiliation': 'Department of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Walkup', 'Affiliation': 'Department of Biostatistics and Data Science, School of Medicine, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Department of Psychiatry, the Miriam Hospital, Alpert Medical School, Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wyatt', 'Affiliation': 'Department of Medicine, School of Medicine, University of Colorado Denver - Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Centers for Disease Control and Prevention, DDT Health Economics Workgroup Atlanta, Atlanta, Georgia, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.23191']
606,34260092,Home viewing of educational video improves patient understanding of Mohs micrographic surgery.,"BACKGROUND


Educational videos improve patient knowledge of wound care and skin cancer. However, the effect of viewing an educational video at home before undergoing Mohs micrographic surgery (MMS) has not been demonstrated.
AIM


To evaluate the use of an educational video to improve patient understanding of MMS.
METHODS


Patients scheduled to undergo MMS were randomized to receive standard patient education, or standard patient education with an additional video developed by the authors. The educational material was posted to patients along with the details of their MMS appointment. Both groups answered questionnaires to assess their knowledge of MMS, and to measure their anxiety and satisfaction.
RESULTS


Patients who watched the educational video scored higher on the knowledge questionnaire than did patients in the control group (0.8, 95% CI 0.3 to 1.4, P < 0.01), but were not statistically less anxious (-0.7, 95% CI -2.6 to 1.3, P = 0.50). Overall, patients undergoing MMS were satisfied.
CONCLUSION


Home viewing of an educational video before MMS can improve patient understanding.",2022,"RESULTS


Patients that watched the educational video scored higher on the knowledge questionnaire than patients in the control group (0.8, 95% CI 0.3 to 1.4, p = 0.003), but were not statistically less anxious (-0.7, 95% CI -2.6 to 1.3, p = 0.50).",[' Patients scheduled to undergo MMS'],"['Home viewing of educational video', 'educational video', 'standard patient education, or standard patient education with an additional video developed by the authors']","['patient knowledge of wound care and skin cancer', 'patient understanding of Mohs Surgery', 'anxious', 'knowledge questionnaire']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0025706', 'cui_str': 'Methylmesilate'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C3812881', 'cui_str': 'Author'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0886052', 'cui_str': 'Wound care'}, {'cui': 'C0007114', 'cui_str': 'Malignant neoplasm of skin'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0079850', 'cui_str': 'Mohs surgery'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.109159,"RESULTS


Patients that watched the educational video scored higher on the knowledge questionnaire than patients in the control group (0.8, 95% CI 0.3 to 1.4, p = 0.003), but were not statistically less anxious (-0.7, 95% CI -2.6 to 1.3, p = 0.50).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mann', 'Affiliation': ""Dermatological Surgery and Laser Unit, St John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kulakov', 'Affiliation': 'Dermatology Department, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy Ltd., Amersham, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Birnie', 'Affiliation': 'Department of Dermatology, East Kent Hospitals University NHS Foundation Trust, Canterbury, UK.'}]",Clinical and experimental dermatology,['10.1111/ced.14845']
607,34259202,Apalutamide for patients with metastatic castrationsensitive prostate cancer in East Asia: a subgroup analysis of the TITAN trial.,"Ethnicity might be associated with treatment outcomes in advanced prostate cancer. This study aimed to evaluate the efficacy and safety of androgen deprivation therapy (ADT) combined with apalutamide in East Asians with metastatic castration-sensitive prostate cancer (mCSPC). The original phase 3 Targeted Investigational Treatment Analysis of Novel Anti-androgen (TITAN) trial was conducted at 260 sites in 23 countries. This subgroup analysis included patients enrolled in 62 participating centers in China, Japan, and Korea. Radiographic progression-free survival (PFS), time to prostate-specific antigen (PSA) progression, and PSA changes from baseline were compared between groups in the East Asian population. The intent-to-treat East Asian population included 111 and 110 participants in the apalutamide and placebo groups, respectively. The 24-month radiographic PFS rates were 76.1% and 52.3% in the apalutamide and placebo groups, respectively (apalutamide vs placebo: hazard ratio [HR] = 0.506; 95% confidence interval [CI], 0.302-0.849; P = 0.009). Median time to PSA progression was more favorable with apalutamide than placebo (HR = 0.210; 95% CI, 0.124-0.357; P < 0.001). Median maximum percentages of PSA decline from baseline were 99.0% and 73.9% in the apalutamide and placebo groups, respectively. The most common adverse event (AE) was rash in the apalutamide group, with a higher rate than that in the placebo group (37.3% vs 9.1%). The most common grade 3 or 4 AEs were rash (12 [10.9%]) and hypertension (12 [10.9%]) for apalutamide. The efficacy and safety of apalutamide in the East Asian subgroup of the TITAN trial are consistent with the global results.",2022,"Median time to PSA progression was more favorable with apalutamide than placebo (HR = 0.210; 95% CI, 0.124-0.357; P < 0.001).","['East Asian subgroup', '260 sites in 23 countries', 'East Asian population included 111 and 110 participants in the apalutamide and placebo groups, respectively', 'patients with metastatic castrationsensitive prostate cancer in East Asia', 'patients enrolled in 62 participating centers in China, Japan, and Korea', 'advanced prostate cancer', 'East Asians with metastatic castration-sensitive prostate cancer (mCSPC']","['placebo', 'androgen deprivation therapy (ADT) combined with apalutamide', 'Apalutamide']","['efficacy and safety', 'Median time to PSA progression', 'Radiographic progression-free survival (PFS), time to prostate-specific antigen (PSA) progression, and PSA changes', 'Median maximum percentages of PSA decline', '24-month radiographic PFS rates', 'rash', 'hypertension']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0015631', 'cui_str': 'Far east country'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",,0.792184,"Median time to PSA progression was more favorable with apalutamide than placebo (HR = 0.210; 95% CI, 0.124-0.357; P < 0.001).","[{'ForeName': 'Byung Ha', 'Initials': 'BH', 'LastName': 'Chung', 'Affiliation': 'Department of Urology, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 135-271, Korea.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Sun Yat-Sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510120, China.'}, {'ForeName': 'Zhang-Qun', 'Initials': 'ZQ', 'LastName': 'Ye', 'Affiliation': 'Wuhan Tongji Hospital, Tongji Medical College, Wuhan 430030, China.'}, {'ForeName': 'Da-Lin', 'Initials': 'DL', 'LastName': 'He', 'Affiliation': ""First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 719054, China.""}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Kindai University Hospital, Ōsakasayama 589-8511, Japan.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Arai', 'Affiliation': 'Dokkyo Medical University Saitama Medical Center, Saitama 2-1-50, Japan.'}, {'ForeName': 'Choung Soo', 'Initials': 'CS', 'LastName': 'Kim', 'Affiliation': 'Asian Medical Center, University of Ulsan, Seoul 138-040, Korea.'}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Zhang', 'Affiliation': 'Janssen Medical Affairs Department, Beijing 100025, China.'}, {'ForeName': 'Yusoke', 'Initials': 'Y', 'LastName': 'Koroki', 'Affiliation': 'Janssen Medical Affairs Department, Tokyo 101-0065, Japan.'}, {'ForeName': 'SuYeon', 'Initials': 'S', 'LastName': 'Jeong', 'Affiliation': 'Janssen Medical Affairs Department, Seoul 140-012, Korea.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Mundle', 'Affiliation': 'Janssen Global Medical Affairs Department, Horsham, PA 08869, USA.'}, {'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Triantos', 'Affiliation': 'Janssen Research and Development, Spring House, PA 19477, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'McCarthy', 'Affiliation': 'Janssen Research and Development, Raritan, NJ 08869, USA.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'BC Cancer and Vancouver Prostate Centre, Vancouver, BC V5Z 1G1, Canada.'}, {'ForeName': 'Ding-Wei', 'Initials': 'DW', 'LastName': 'Ye', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai 200032, China.'}]",Asian journal of andrology,['10.4103/aja.aja_64_21']
608,34266853,Impact on quality of life from multimodality treatment for lung cancer: a randomised controlled feasibility trial of surgery versus no surgery as part of multimodality treatment in potentially resectable stage III-N2 NSCLC (the PIONEER trial).,"INTRODUCTION


Optimal treatment for 'potentially resectable' stage III-N2 non-small cell lung cancer (NSCLC) requires multimodality treatment: local treatment (surgery or radiotherapy) and systemic anticancer therapy. There is no clear evidence of superiority for survival between the two approaches and little research has explored quality of life (QOL). This study will inform the design of a phase III randomised trial of surgery versus no surgery as part of multimodality treatment for stage III-N2 NSCLC with QOL as a primary outcome.
METHODS AND ANALYSIS


Patient participants will be randomised to receive multimodality treatment (1) with surgery OR (2) without surgery. The Quintet Recruitment Intervention will be used to maximise recruitment. Eligible patients will have 'potentially resectable' N2 NSCLC and have received a multidisciplinary team recommendation for multimodality treatment. Sixty-six patients and their carers will be recruited from 8 UK centres. Patient/carer QOL questionnaires will be administered at baseline, weeks 6, 9, 12 and month 6. Semistructured interviews will be conducted. Quantitative data will be analysed descriptively and qualitative data will be analysed using framework analysis.
ETHICS AND DISSEMINATION


Ethical approval has been obtained. Results will be disseminated via publications, national bodies and networks, and patient and public involvement groups.
TRIAL REGISTRATION


NCT04540757.",2021,There is no clear evidence of superiority for survival between the two approaches and little research has explored quality of life (QOL).,"[""Eligible patients will have 'potentially resectable' N2 NSCLC and have received a multidisciplinary team recommendation for multimodality treatment"", 'lung cancer', ""potentially resectable' stage III-N2 non-small cell lung cancer (NSCLC) requires"", 'Sixty-six patients and their carers will be recruited from 8 UK centres']","['surgery versus no surgery', 'multimodality treatment: local treatment (surgery or radiotherapy) and systemic anticancer therapy', 'multimodality treatment (1) with surgery OR (2) without surgery']","['quality of life (QOL', 'quality of life', 'Patient/carer QOL questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",66.0,0.451104,There is no clear evidence of superiority for survival between the two approaches and little research has explored quality of life (QOL).,"[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Christie Patient Centred Research, The Christie NHS Foundation Trust, Manchester, UK sally.taylor38@nhs.net.'}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Yorke', 'Affiliation': 'Christie Patient Centred Research, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Selina', 'Initials': 'S', 'LastName': 'Tsim', 'Affiliation': 'Glasgow Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Navani', 'Affiliation': 'Lungs For Living Research Centre, University College London and Department of Thoracic Medicine, University College London Hospital, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baldwin', 'Affiliation': 'Respiratory Medicine Unit, David Evans Research Centre, Nottingham University Hospitals NHS Trust, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Woolhouse', 'Affiliation': 'Department of Respiratory Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Edwards', 'Affiliation': 'Department of Cardiothoracic Surgery, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, Sheffield, UK.'}, {'ForeName': 'Seamus', 'Initials': 'S', 'LastName': 'Grundy', 'Affiliation': 'Respiratory Medicine, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Robson', 'Affiliation': 'Leeds Teaching Hospital Trusts, Leeds, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rhodes', 'Affiliation': 'University of Manchester, Manchester, UK.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Gomes', 'Affiliation': 'Christie Patient Centred Research, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Blackhall', 'Affiliation': 'University of Manchester, Manchester, UK.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'University of Manchester, Manchester, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Evison', 'Affiliation': 'Lung Cancer & Thoracic Surgery Directorate, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000846']
609,34264696,A mindfulness-based mobile health (mHealth) intervention among psychologically distressed university students in quarantine during the COVID-19 pandemic: A randomized controlled trial.,"This randomized controlled trial evaluated the effect of a mindfulness-based mobile health (mHealth) intervention, tailored to the pandemic context, among young adult students (N = 114) with elevated anxiety and/or depressive symptoms during quarantine in China, compared to a time- and attention-matched social support-based mHealth control. At baseline, postintervention (1 month), and 2-month follow-up, participants completed self-reports of primary outcomes (anxiety and depression), secondary outcomes (mindfulness and social support), and emotional suppression as a culturally relevant mechanism of change. Feasibility and acceptability were also evaluated. Using intent-to-treat (ITT) analysis, linear mixed effects models showed that compared to social support mHealth, mindfulness mHealth had a superior effect on anxiety (p = .024, between-group d = 0.72). Both conditions improved on depression (baseline-to-FU ds > 1.10, between-group difference not significant, d = 0.36 favoring mindfulness). There was an interaction of Emotional suppression reduction × Condition in the improvement of anxiety and depression. Further, mindfulness mHealth was demonstrated to be more feasible and acceptable in program engagement, evaluation, skills improvement, and perceived benefit. Retention was high in both conditions (>80%). The difference in self-reported adverse effect was nonsignificant (3.9% in mindfulness and 8.7% in social support). Results of this pilot trial suggest that both mindfulness and social support, delivered via mHealth, show promise in reducing distress among young adults in quarantine, with mindfulness being particularly effective in addressing anxiety. Successful implementation and dissemination of this mHealth intervention approach have the potential for addressing the psychological consequences of the pandemic. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Both conditions improved on depression (baseline-to-FU ds > 1.10, between-group difference not significant, d = 0.36 favoring mindfulness).","['young adult students (N = 114) with elevated anxiety and/or depressive symptoms during quarantine in China, compared to a time- and attention-matched social support-based mHealth control', 'psychologically distressed university students in quarantine during the COVID-19 pandemic']",['mindfulness-based mobile health (mHealth) intervention'],"['anxiety', 'depression', 'self-reported adverse effect', 'Feasibility and acceptability', 'self-reports of primary outcomes (anxiety and depression), secondary outcomes (mindfulness and social support), and emotional suppression as a culturally relevant mechanism of change', 'anxiety and depression', 'feasible and acceptable in program engagement, evaluation, skills improvement, and perceived benefit']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0034386', 'cui_str': 'Quarantine'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",114.0,0.0741976,"Both conditions improved on depression (baseline-to-FU ds > 1.10, between-group difference not significant, d = 0.36 favoring mindfulness).","[{'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health.'}, {'ForeName': 'Danhua', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'Institute of Developmental Psychology, Department of Psychology, Beijing Normal University.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Goldberg', 'Affiliation': 'Department of Counseling Psychology, University of Wisconsin-Madison College of Education.'}, {'ForeName': 'Zijiao', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Institute of Developmental Psychology, Department of Psychology, Beijing Normal University.'}, {'ForeName': 'Pujing', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Institute of Developmental Psychology, Department of Psychology, Beijing Normal University.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, University of South Carolina Arnold School of Public Health.'}, {'ForeName': 'Judson', 'Initials': 'J', 'LastName': 'Brewer', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Loucks', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Operario', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health.'}]",Journal of counseling psychology,['10.1037/cou0000568']
610,34269326,Visual outcomes and safety of an extended depth-of-focus intraocular lens: results of a pivotal clinical trial.,"PURPOSE


To compare the effectiveness and safety of the TECNIS Symfony intraocular lens (IOL; ZXR00) with the TECNIS 1-piece monofocal IOL (ZCB00).
SETTING


15 sites in the United States.
DESIGN


Prospective, randomized, patient-masked/evaluator-masked clinical trial.
METHODS


Randomized participants received either the ZXR00 or ZCB00 IOL bilaterally. The 6-month postoperative outcomes included monocular and binocular distance, intermediate, and near visual acuity (VA), spherical equivalent refraction and refractive cylinder, spectacle wear, and visual symptoms.
RESULTS


Overall, 299 patients were implanted with a study IOL (ZXR00 IOL, n = 148; ZCB00 IOL control, n = 151). At the 6-month follow-up, mean binocular uncorrected distance VA was comparable between ZXR00 and ZCB00 IOL recipients (P = .1011). The ZXR00 IOL group had significantly better mean binocular uncorrected intermediate VA and uncorrected near VA (both P < .0001) than the ZCB00 IOL group. The mean binocular distance-corrected intermediate VA and distance-corrected near VA were also better in the ZXR00 IOL group (both P < .0001). More ZXR00 IOL recipients reported wearing spectacles none of the time or a little of the time for overall vision at 6 months compared with the ZCB00 IOL group (85.0% vs 59.9%, P < .0001). In the ZXR00 IOL-implanted patients, low incidence rates of night glare (mild to moderate, 2.7%), halo (mild to moderate, 13.6%; severe, 2.7%), and starbursts (mild to moderate, 7.5%; severe, 1.4%) were reported.
CONCLUSIONS


The TECNIS Symfony IOL provided comparable distance vision and improved uncorrected and distance-corrected intermediate and near vision, along with decreased spectacle wear and low incidence rates of dysphotopsia, compared with the TECNIS 1-piece monofocal IOL.",2022,"The TECNIS Symfony® IOL provided comparable distance vision and improved uncorrected and distance-corrected intermediate and near vision, along with decreased spectacle wear and low incidence rates of dysphotopsias, compared with the TECNIS® 1-piece monofocal IOL.","['299 patients were implanted with a study lens (ZXR00, n = 148; ZCB00 control, n = 151', 'Fifteen sites in the United States']","['TECNIS Symfony® intraocular lens (IOL; ZXR00', 'ZCB00', 'TECNIS Symfony intraocular lens', 'ZXR00 or ZCB00 IOL bilaterally']","['overall vision', 'Mean binocular distance-corrected intermediate VA and distance-corrected near VA', 'mean binocular uncorrected distance VA', 'mean binocular uncorrected intermediate VA and uncorrected near VA', 'distance vision and improved uncorrected and distance-corrected intermediate and near vision', 'monocular and binocular distance, intermediate, and near visual acuity (VA), spherical equivalent refraction and refractive cylinder, spectacle wear, and visual symptoms', 'low incidence rates of night glare']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0422943', 'cui_str': 'Visual symptoms'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1328586', 'cui_str': 'Night glare'}]",299.0,0.171281,"The TECNIS Symfony® IOL provided comparable distance vision and improved uncorrected and distance-corrected intermediate and near vision, along with decreased spectacle wear and low incidence rates of dysphotopsias, compared with the TECNIS® 1-piece monofocal IOL.","[{'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Chang', 'Affiliation': 'From the Empire Eye and Laser Center, Bakersfield, California (Chang); Johnson & Johnson Vision, Santa Ana, California (Janakiraman, Smith, Buteyn, Domingo); Jones Eye Clinic, Sioux City, Iowa (Jones); Scott & Christie and Associates, PC, Cranberry Township, Pennsylvania (Christie).'}, {'ForeName': 'Devi Priya', 'Initials': 'DP', 'LastName': 'Janakiraman', 'Affiliation': ''}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Buteyn', 'Affiliation': ''}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Domingo', 'Affiliation': ''}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Christie', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000747']
611,34261798,Repurposed floxacins targeting RSK4 prevent chemoresistance and metastasis in lung and bladder cancer.,"Lung and bladder cancers are mostly incurable because of the early development of drug resistance and metastatic dissemination. Hence, improved therapies that tackle these two processes are urgently needed to improve clinical outcome. We have identified RSK4 as a promoter of drug resistance and metastasis in lung and bladder cancer cells. Silencing this kinase, through either RNA interference or CRISPR, sensitized tumor cells to chemotherapy and hindered metastasis in vitro and in vivo in a tail vein injection model. Drug screening revealed several floxacin antibiotics as potent RSK4 activation inhibitors, and trovafloxacin reproduced all effects of RSK4 silencing in vitro and in/ex vivo using lung cancer xenograft and genetically engineered mouse models and bladder tumor explants. Through x-ray structure determination and Markov transient and Deuterium exchange analyses, we identified the allosteric binding site and revealed how this compound blocks RSK4 kinase activation through binding to an allosteric site and mimicking a kinase autoinhibitory mechanism involving the RSK4's hydrophobic motif. Last, we show that patients undergoing chemotherapy and adhering to prophylactic levofloxacin in the large placebo-controlled randomized phase 3 SIGNIFICANT trial had significantly increased ( P  = 0.048) long-term overall survival times. Hence, we suggest that RSK4 inhibition may represent an effective therapeutic strategy for treating lung and bladder cancer.",2021,"Silencing this kinase, through either RNA interference or CRISPR, sensitized tumor cells to chemotherapy and hindered metastasis in vitro and in vivo in a tail vein injection model.",[],['levofloxacin'],['overall survival times'],[],"[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",,0.153077,"Silencing this kinase, through either RNA interference or CRISPR, sensitized tumor cells to chemotherapy and hindered metastasis in vitro and in vivo in a tail vein injection model.","[{'ForeName': 'Stelios', 'Initials': 'S', 'LastName': 'Chrysostomou', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Roy', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Prischi', 'Affiliation': 'School of Biological Sciences, University of Essex, Colchester CO4 3SQ, UK.'}, {'ForeName': 'Lucksamon', 'Initials': 'L', 'LastName': 'Thamlikitkul', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Chapman', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'Uwais', 'Initials': 'U', 'LastName': 'Mufti', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Peach', 'Affiliation': 'Department of Chemistry, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'Laifeng', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Key Laboratory of Magnetic Resonance in Biological Systems, National Centre for Magnetic Resonance in Wuhan, State Key Laboratory of Magnetic Resonance and Atomic and Molecular Physics, Wuhan Institute of Physics and Mathematics, Chinese Academy of Sciences, Wuhan 430071, China.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hancock', 'Affiliation': 'Oncogene Biology Laboratory, The Francis Crick Institute, London NW1 1AT, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': 'Oncogene Biology Laboratory, The Francis Crick Institute, London NW1 1AT, UK.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Molina-Arcas', 'Affiliation': 'Oncogene Biology Laboratory, The Francis Crick Institute, London NW1 1AT, UK.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Mauri', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Pinato', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Abrahams', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ottaviani', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Castellano', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Giamas', 'Affiliation': 'Department of Biochemistry and Biomedicine, School of Life Sciences, University of Sussex, Falmer, Brighton BN1 9QG, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pascoe', 'Affiliation': 'Department of Oncology, University Hospitals Birmingham NHS Foundation Trust, Birmingham B15 2TH, UK.'}, {'ForeName': 'Devmini', 'Initials': 'D', 'LastName': 'Moonamale', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pirrie', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Gaunt', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Billingham', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Steven', 'Affiliation': 'Department of Oncology, University Hospitals Birmingham NHS Foundation Trust, Birmingham B15 2TH, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cullen', 'Affiliation': 'Department of Oncology, University Hospitals Birmingham NHS Foundation Trust, Birmingham B15 2TH, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hrouda', 'Affiliation': 'Department Urology, Charing Cross Hospital, London W6 8RF, UK.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Winkler', 'Affiliation': 'Department Urology, Charing Cross Hospital, London W6 8RF, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Post', 'Affiliation': 'MRC Protein Phosphorylation and Ubiquitylation Unit, School of Life Sciences, University of Dundee, Dow Street, Dundee DD1 5EH. UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cohen', 'Affiliation': 'MRC Protein Phosphorylation and Ubiquitylation Unit, School of Life Sciences, University of Dundee, Dow Street, Dundee DD1 5EH. UK.'}, {'ForeName': 'Seth J', 'Initials': 'SJ', 'LastName': 'Salpeter', 'Affiliation': 'Curesponse, 6 Weizmann Street, 6423906 Tel Aviv, Israel.'}, {'ForeName': 'Vered', 'Initials': 'V', 'LastName': 'Bar', 'Affiliation': 'Curesponse, 6 Weizmann Street, 6423906 Tel Aviv, Israel.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Zundelevich', 'Affiliation': 'Curesponse, 6 Weizmann Street, 6423906 Tel Aviv, Israel.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'Golan', 'Affiliation': 'Department of Urology, Rabin Medical Center, Jabotinsky St. 39, 4941492 Petah Tikva, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Leibovici', 'Affiliation': 'Department of Urology, Kaplan Medical Center, 7610001 Rehovot, Israel.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Lara', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Klug', 'Affiliation': 'Department of Chemistry, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'Sophia N', 'Initials': 'SN', 'LastName': 'Yaliraki', 'Affiliation': 'Department of Chemistry, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Barahona', 'Affiliation': 'Department of Mathematics, Imperial College London, London SW7 2AZ, UK.'}, {'ForeName': 'Yulan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore 636921, Singapore.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Downward', 'Affiliation': 'Oncogene Biology Laboratory, The Francis Crick Institute, London NW1 1AT, UK.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'Skehel', 'Affiliation': 'Biological Mass Spectrometry and Proteomics, MRC LMB, Cambridge CB2 0QH, UK.'}, {'ForeName': 'Maruf M U', 'Initials': 'MMU', 'LastName': 'Ali', 'Affiliation': 'Department of Life Sciences, Imperial College London, London SW7 2AZ, UK. maruf.ali@imperial.ac.uk m.seckl@imperial.ac.uk o.pardo@imperial.ac.uk.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Seckl', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London SW7 2AZ, UK. maruf.ali@imperial.ac.uk m.seckl@imperial.ac.uk o.pardo@imperial.ac.uk.'}, {'ForeName': 'Olivier E', 'Initials': 'OE', 'LastName': 'Pardo', 'Affiliation': 'Division of Cancer, Department of Surgery and Cancer, Imperial College London, London SW7 2AZ, UK. maruf.ali@imperial.ac.uk m.seckl@imperial.ac.uk o.pardo@imperial.ac.uk.'}]",Science translational medicine,['10.1126/scitranslmed.aba4627']
612,34266520,Mid-Tibiofibular Amputation as a Method of Terminal Blood Collection in  Xenopus   Laevis .,"The African clawed frog,  Xenopus laevis , is a widely used model for biomedical research.  X. laevis  could be more useful as a model with a better method for collection and analysis of its blood and serum. However, blood collection in  X. laevis  can be challenging due to their small size, lack of peripheral vascular access, and species-specific hematology variables. The goal of this study was to compare cardiocentesis, the current gold standard terminal blood collection method, with a leg amputation technique. Blood samples were collected from 24 laboratory-reared  X. laevis,  randomized to either the cardiocentesis or leg amputation method, with 6 males and 6 females in each group. Hematology and serum biochemistry were also conducted to identify any lymph contamination in the samples. The leg amputation method produced significantly higher blood volumes in shorter times and showed no significant differences in clinical pathology parameters as compared with cardiocentesis. These results indicate that blood collection by leg amputation may be a valuable approach for increasing the utility of an already valuable biomedical research model.",2021,The leg amputation method produced significantly higher blood volumes in shorter times and showed no significant differences in clinical pathology parameters as compared with cardiocentesis.,[],[],"['blood volumes', 'clinical pathology parameters']",[],[],"[{'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0030667', 'cui_str': 'Clinical Pathology'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.00648172,The leg amputation method produced significantly higher blood volumes in shorter times and showed no significant differences in clinical pathology parameters as compared with cardiocentesis.,"[{'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Dixon', 'Affiliation': 'Veterinary Medicine Division, United States Army Medical Research Institute of Infectious Diseases, Frederick, Maryland;, Email: Benjamin.c.dixon.mil@mail.mil.'}, {'ForeName': 'Marilynn J', 'Initials': 'MJ', 'LastName': 'Culbreth', 'Affiliation': 'Veterinary Medicine Division, United States Army Medical Research Institute of Infectious Diseases, Frederick, Maryland.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kumsher', 'Affiliation': 'Experimental Therapeutics, Walter Reed Army Institute of Research, Silver Springs, Maryland.'}, {'ForeName': 'Chance M', 'Initials': 'CM', 'LastName': 'Carbaugh', 'Affiliation': 'Experimental Therapeutics, Walter Reed Army Institute of Research, Silver Springs, Maryland.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Fetterer', 'Affiliation': 'Veterinary Medicine Division, United States Army Medical Research Institute of Infectious Diseases, Frederick, Maryland.'}, {'ForeName': 'Cara P', 'Initials': 'CP', 'LastName': 'Reiter', 'Affiliation': 'Veterinary Medicine Division, United States Army Medical Research Institute of Infectious Diseases, Frederick, Maryland.'}]",Journal of the American Association for Laboratory Animal Science : JAALAS,['10.30802/AALAS-JAALAS-21-000005']
613,34268888,"Clinical evaluation of large volume subcutaneous injection tissue effects, pain, and acceptability in healthy adults.","Determining feasibility and tolerability of large volume viscous subcutaneous injection may enable optimized, intuitive delivery system design. A translational early feasibility clinical study examined large volume subcutaneous injection viability, tolerability, acceptability, tissue effects and depot location for ~1, 8, and 20 cP injections at volumes up to 10 ml in the abdomen and 5 ml in the thigh in 32 healthy adult subjects. A commercial syringe pump system delivered 192 randomized, constant rate (20 µl/s) injections (6/subject) with in-line injection pressure captured versus time. Deposition location was qualified via ultrasound. Tissue effects and pain tolerability were monitored through 2 hours post-injection with corresponding Likert acceptability questionnaires administered through 72 hours. All injection conditions were feasible and well-tolerated with ≥79.3% favorable subject responses for injection site appearance and sensation immediately post-injection, increasing to ≥96.8% at 24 hours. Mean subject pain measured via 100 mm visual analog scale increased at needle insertion (6.9 mm, SD 10.8), peaked during injection (26.9 mm, SD 21.7) and diminished within 10 minutes post-removal (1.9 mm, SD 4.2). Immediate injection site wheal (90.9%) and erythema (92.6%) formation was observed with progressive although incomplete resolution through 2 hours (44.6% and 11.4% remaining, respectively). Wheal resolution occurred more rapidly at lower viscosities. Most subjects (64.5%) had no preference between abdomen and thigh. Correlations between tissue effects, injection pressure and pain were weak (Pearson's rho ± 0-0.4). The large volume injections tested, 1-20 cP viscosities up to 10 ml in the abdomen and 5 ml in the thigh, are feasible with good subject acceptability and rapid resolution of tissue effects and pain.",2022,"Immediate injection site wheal (90.9%) and erythema (92.6%) formation was observed with progressive although incomplete resolution through 2 hours (44.6% and 11.4% remaining, respectively).","['Healthy Adults', '32 healthy adult subjects']",[],"['Wheal resolution', 'Tissue effects and pain tolerability', 'Pain, and Acceptability', 'tolerability, acceptability, tissue effects and depot location', 'erythema', 'tissue effects, injection pressure and pain', 'feasible and well-tolerated', 'Mean subject pain measured via 100mm visual analog scale']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0221232', 'cui_str': 'Weal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",32.0,0.0325038,"Immediate injection site wheal (90.9%) and erythema (92.6%) formation was observed with progressive although incomplete resolution through 2 hours (44.6% and 11.4% remaining, respectively).","[{'ForeName': 'Wendy D', 'Initials': 'WD', 'LastName': 'Woodley', 'Affiliation': 'BD Technologies & Innovation, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Didier R', 'Initials': 'DR', 'LastName': 'Morel', 'Affiliation': 'BD Medical- Pharmaceutical Systems, Le Pont de Claix, France.'}, {'ForeName': 'Diane E', 'Initials': 'DE', 'LastName': 'Sutter', 'Affiliation': 'BD Technologies & Innovation, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Pettis', 'Affiliation': 'BD Technologies & Innovation, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Natasha G', 'Initials': 'NG', 'LastName': 'Bolick', 'Affiliation': 'BD Technologies & Innovation, Research Triangle Park, North Carolina, USA.'}]",Clinical and translational science,['10.1111/cts.13109']
614,34260849,Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19.,"BACKGROUND


Patients with underlying medical conditions are at increased risk for severe coronavirus disease 2019 (Covid-19). Whereas vaccine-derived immunity develops over time, neutralizing monoclonal-antibody treatment provides immediate, passive immunity and may limit disease progression and complications.
METHODS


In this phase 3 trial, we randomly assigned, in a 1:1 ratio, a cohort of ambulatory patients with mild or moderate Covid-19 who were at high risk for progression to severe disease to receive a single intravenous infusion of either a neutralizing monoclonal-antibody combination agent (2800 mg of bamlanivimab and 2800 mg of etesevimab, administered together) or placebo within 3 days after a laboratory diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The primary outcome was the overall clinical status of the patients, defined as Covid-19-related hospitalization or death from any cause by day 29.
RESULTS


A total of 1035 patients underwent randomization and received an infusion of bamlanivimab-etesevimab or placebo. The mean (±SD) age of the patients was 53.8±16.8 years, and 52.0% were adolescent girls or women. By day 29, a total of 11 of 518 patients (2.1%) in the bamlanivimab-etesevimab group had a Covid-19-related hospitalization or death from any cause, as compared with 36 of 517 patients (7.0%) in the placebo group (absolute risk difference, -4.8 percentage points; 95% confidence interval [CI], -7.4 to -2.3; relative risk difference, 70%; P<0.001). No deaths occurred in the bamlanivimab-etesevimab group; in the placebo group, 10 deaths occurred, 9 of which were designated by the trial investigators as Covid-19-related. At day 7, a greater reduction from baseline in the log viral load was observed among patients who received bamlanivimab plus etesevimab than among those who received placebo (difference from placebo in the change from baseline, -1.20; 95% CI, -1.46 to -0.94; P<0.001).
CONCLUSIONS


Among high-risk ambulatory patients, bamlanivimab plus etesevimab led to a lower incidence of Covid-19-related hospitalization and death than did placebo and accelerated the decline in the SARS-CoV-2 viral load. (Funded by Eli Lilly; BLAZE-1 ClinicalTrials.gov number, NCT04427501.).",2021,"At day 7, a greater reduction from baseline in the log viral load was observed among patients who received bamlanivimab plus etesevimab than among those who received placebo (difference from placebo in the change from baseline, -1.20; 95% CI, -1.46 to -0.94; P<0.001).
","['The mean (±SD) age of the patients was 53.8±16.8 years, and 52.0% were adolescent girls or women', 'Mild or Moderate Covid-19', 'ambulatory patients with mild or moderate Covid-19 who were at high risk for progression to severe disease to receive a single intravenous infusion of either a', '1035 patients underwent randomization and received an']","['placebo', 'neutralizing monoclonal-antibody combination agent (2800 mg of bamlanivimab and 2800 mg of etesevimab, administered together) or placebo', 'Bamlanivimab plus Etesevimab', 'infusion of bamlanivimab-etesevimab or placebo']","['Covid-19-related hospitalization and death', 'overall clinical status of the patients, defined as Covid-19-related hospitalization or death', 'log viral load', 'deaths', 'Covid-19-related hospitalization or death']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C4517680', 'cui_str': '2800'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",1035.0,0.771569,"At day 7, a greater reduction from baseline in the log viral load was observed among patients who received bamlanivimab plus etesevimab than among those who received placebo (difference from placebo in the change from baseline, -1.20; 95% CI, -1.46 to -0.94; P<0.001).
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dougan', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nirula', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Azizad', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Mocherla', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Hebert', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Perry', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Boscia', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Heller', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Crystal', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Awawu', 'Initials': 'A', 'LastName': 'Igbinadolor', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Huhn', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cardona', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Shawa', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Princy', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Adams', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Van Naarden', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Custer', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Durante', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Oakley', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Schade', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Holzer', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Ebert', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Higgs', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Kallewaard', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Sabo', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Dipak R', 'Initials': 'DR', 'LastName': 'Patel', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Matan C', 'Initials': 'MC', 'LastName': 'Dabora', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Skovronsky', 'Affiliation': ""From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2102685']
615,34265007,"Pilot study of extended-release lorcaserin for cocaine use disorder among men who have sex with men: A double-blind, placebo-controlled randomized trial.","OBJECTIVE


To determine if men who have sex with men (MSM) with cocaine use disorder (CUD) and actively-using cocaine could be enrolled and retained in a pharmacologic intervention trial of lorcaserin-a novel 5-HT2cR agonist-and determine the degree to which participants would adhere to study procedures.
METHODS


This was a phase II randomized, double-blind, placebo-controlled pilot study with 2:1 random parallel group assignment to daily extended-release oral lorcaserin 20 mg versus placebo (clinicaltrials.gov identifier-NCT03192995). Twenty-two of a planned 45 cisgender MSM with CUD were enrolled and had weekly follow-up visits during a 12-week treatment period, with substance use counseling, urine specimen collection, and completion of audio-computer assisted self-interview (ACASI) behavioral risk assessments. Adherence was measured by medication event monitoring systems (MEMS) caps and self-report. This study was terminated early because of an FDA safety alert for lorcaserin's long-term use.
RESULTS


Eighty-six percent completed the trial, with 82% of weekly study follow-up visits completed. Adherence was 55.3% (lorcaserin 51.6% vs. placebo 66.2%) by MEMS cap and 56.9% (56.5% vs. placebo 57.9%) by self-report and did not differ significantly by treatment assignment. Intention-to-treat analyses (ITT) did not show differences in cocaine positivity by urine screen between the lorcaserin and placebo groups by 12 week follow-up (incidence risk ratio [IRR]: 0.96; 95%CI = 0.24-3.82, P = 0.95). However, self-reported cocaine use in timeline follow-back declined more significantly in the lorcaserin group compared to placebo (IRR: 0.66; 95%CI = 0.49-0.88; P = 0.004).
CONCLUSION


We found that it is feasible, acceptable, and tolerable to conduct a placebo-controlled pharmacologic trial for MSM with CUD who are actively using cocaine. Lorcaserin was not associated with significant reductions in cocaine use by urine testing, but was associated with significant reductions in self-reported cocaine use. Future research may be needed to continue to explore the potential utility of 5-HT2cR agonists.",2021,"Intention-to-treat analyses (ITT) did not show differences in cocaine positivity by urine screen between the lorcaserin and placebo groups by 12 week follow-up (incidence risk ratio [IRR]: 0.96; 95%CI = 0.24-3.82, P = 0.95).","['Twenty-two of a planned 45 cisgender MSM with CUD were enrolled and had weekly follow-up visits during a 12-week treatment period, with', 'men who have sex with men (MSM) with cocaine use disorder (CUD) and actively-using', 'men who have sex with men', 'Eighty-six percent completed the trial, with 82% of weekly study follow-up visits completed']","['cocaine', 'extended-release lorcaserin', 'placebo', 'daily extended-release oral lorcaserin', 'substance use counseling, urine specimen collection, and completion of audio-computer assisted self-interview (ACASI) behavioral risk assessments']","['cocaine positivity by urine screen', 'Adherence']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C2350948', 'cui_str': 'lorcaserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.506913,"Intention-to-treat analyses (ITT) did not show differences in cocaine positivity by urine screen between the lorcaserin and placebo groups by 12 week follow-up (incidence risk ratio [IRR]: 0.96; 95%CI = 0.24-3.82, P = 0.95).","[{'ForeName': 'Glenn-Milo', 'Initials': 'GM', 'LastName': 'Santos', 'Affiliation': 'Department of Community Health Systems, University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Ikeda', 'Affiliation': 'Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Coffin', 'Affiliation': 'Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Walker', 'Affiliation': 'Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Matheson', 'Affiliation': 'Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McLaughlin', 'Affiliation': 'Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, CA, United States of America.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jain', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Batki', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, CA, United States of America.'}]",PloS one,['10.1371/journal.pone.0254724']
616,34275398,Outcomes of Canaliculotomy with and without Silicone Tube Intubation in Management of Primary Canaliculitis.,"PURPOSE


To compare the outcomes of canaliculotomy and curettage with and without silicone tube intubation in the treatment of primary canaliculitis.
METHODS


A prospective, randomized, interventional case series was performed. Fifty patients diagnosed with unilateral inferior primary canaliculitis underwent canaliculotomy with curettage and were randomly divided into two groups depending on silicone tube intubation. Twenty-five patients were recruited in group A (without intubation) and 25 patients were recruited in group B (with intubation). The resolution of infection, the success rate and postoperative complications observed in both groups were analyzed with a minimum follow-up of 1 year.
RESULTS


Forty-seven patients were finally included in the study consisting of 23 patients in group A and 24 patients in group B. There were 33 females and 14 males with a median age of 57 ± 13.9 years (range 29-89 years). All patients recorded complete resolution of canaliculitis and no recurrent infections were observed in the 2 groups during follow-up. A significantly higher number of anatomical and functional successes were achieved in patients in group B (100%, 87.5%) than in group A (78.3%, 60.9%) ( P  < .05,). The surgical complication of canalicular obstruction was significantly higher in patients in group A (21.7%, 5/23) compared to group B (0/24)(P < .05).
CONCLUSION


Canaliculotomy with curettage gives excellent clinical outcomes in the treatment of patients with primary canaliculitis and a higher success rate can be achieved when silicone tube intubation is performed during the procedure. The use of silicone tube intubation may be a necessary choice in canaliculotomy to avoid post-operative canalicular obstruction.",2021,All patients recorded complete resolution of canaliculitis and no recurrent infections were observed in the 2 groups during follow-up.,"['33 females and 14 males with a median age of 57\xa0±\xa013.9\xa0years (range 29-89\xa0years', 'primary canaliculitis', 'patients with primary canaliculitis', 'Twenty-five patients were recruited in group A (without intubation) and 25 patients were recruited in group B (with intubation', 'Fifty patients diagnosed with unilateral inferior primary canaliculitis underwent', 'Forty-seven patients were finally included in the study consisting of 23 patients in group A and 24 patients in group']","['silicone tube intubation', 'canaliculotomy with curettage', 'canaliculotomy and curettage with and without silicone tube intubation', 'Canaliculotomy with and without Silicone Tube Intubation']","['complete resolution of canaliculitis and no recurrent infections', 'resolution of infection, the success rate and postoperative complications', 'surgical complication of canalicular obstruction', 'number of anatomical and functional successes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0423172', 'cui_str': 'Lacrimal canaliculus inflamed'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0423172', 'cui_str': 'Lacrimal canaliculus inflamed'}, {'cui': 'C0239998', 'cui_str': 'Recurrent infectious disease'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0022906', 'cui_str': 'Blocked lacrimal canaliculus'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",25.0,0.0095404,All patients recorded complete resolution of canaliculitis and no recurrent infections were observed in the 2 groups during follow-up.,"[{'ForeName': 'Mingling', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Baoan Central Hospital of Shenzhen (The Fifth Affiliated Hospital of Shenzhen University), Shenzhen, China.'}, {'ForeName': 'Richang', 'Initials': 'R', 'LastName': 'Cong', 'Affiliation': 'Department of Ophthalmology, Baoan Central Hospital of Shenzhen (The Fifth Affiliated Hospital of Shenzhen University), Shenzhen, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Department of Orbital and Oculoplastic Surgery, Eye Hospital of Wenzhou Medical University, Wenzhou, China.'}]",Current eye research,['10.1080/02713683.2021.1942074']
617,34281934,Direct swallowing training and oral sensorimotor stimulation in preterm infants: a randomised controlled trial.,"OBJECTIVE


To evaluate the effects of direct swallowing training (DST) alone and combined with oral sensorimotor stimulation (OSMS) on oral feeding ability in very preterm infants.
DESIGN


Blinded, parallel group, randomised controlled trial (1:1:1).
SETTING


Neonatal intensive care unit of a South Korean tertiary hospital.
PARTICIPANTS


Preterm infants born at <32 weeks of gestation who achieved full tube feeding.
INTERVENTIONS


Two sessions per day were provided according to the randomly assigned groups (control: two times per day sham intervention; DST: DST and sham interventions, each once a day; DST+OSMS: DST and OSMS interventions, each once a day).
PRIMARY OUTCOME


Time from start to independent oral feeding (IOF).
RESULTS


Analyses were conducted in 186 participants based on modified intention-to-treat (63 control; 63 DST; 60 DST+OSMS). The mean time from start to IOF differed significantly between the control, DST and DST+OSMS groups (21.1, 17.2 and 14.8 days, respectively, p=0.02). Compared with non-intervention, DST+OSMS significantly shortened the time from start to IOF (effect size: -0.49; 95% CI: -0.86 to -0.14; p=0.02), whereas DST did not. The proportion of feeding volume taken during the initial 5 min, an index of infants' actual feeding ability when fatigue is minimal, increased earlier in the DST+OSMS than in the DST.
CONCLUSIONS


In very preterm infants, DST+OSMS led to the accelerated attainment of IOF compared with non-intervention, whereas DST alone did not. The effect of DST+OSMS on oral feeding ability appeared earlier than that of DST alone.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT02508571).",2022,"The mean time from start to IOF differed significantly between the control, DST and DST+OSMS groups (21.1, 17.2 and 14.8 days, respectively, p=0.02).","['preterm infants', 'very preterm infants', 'Preterm infants born at <32 weeks of gestation who achieved full tube feeding', '186 participants based on modified intention-to-treat (63 control; 63 DST; 60 DST+OSMS', 'Neonatal intensive care unit of a South Korean tertiary hospital']","['Direct swallowing training and oral sensorimotor stimulation', 'direct swallowing training (DST) alone and combined with oral sensorimotor stimulation (OSMS', 'DST']","['oral feeding ability', 'mean time from start to IOF', 'Time from start to independent oral feeding (IOF']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1299583', 'cui_str': 'Independent'}]",186.0,0.124098,"The mean time from start to IOF differed significantly between the control, DST and DST+OSMS groups (21.1, 17.2 and 14.8 days, respectively, p=0.02).","[{'ForeName': 'Ju Sun', 'Initials': 'JS', 'LastName': 'Heo', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, Korea (the Republic of).'}, {'ForeName': 'Ee-Kyung', 'Initials': 'EK', 'LastName': 'Kim', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, Korea (the Republic of) kimek@snu.ac.kr.'}, {'ForeName': 'Sae Yun', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, Korea (the Republic of).'}, {'ForeName': 'In Gyu', 'Initials': 'IG', 'LastName': 'Song', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, Korea (the Republic of).'}, {'ForeName': 'Young Mi', 'Initials': 'YM', 'LastName': 'Yoon', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, Korea (the Republic of).'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, Korea (the Republic of).'}, {'ForeName': 'Eun Sun', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, Korea (the Republic of).'}, {'ForeName': 'Seung Han', 'Initials': 'SH', 'LastName': 'Shin', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, Korea (the Republic of).'}, {'ForeName': 'Byung-Mo', 'Initials': 'BM', 'LastName': 'Oh', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul, Korea (the Republic of).'}, {'ForeName': 'Hyung-Ik', 'Initials': 'HI', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul, Korea (the Republic of).'}, {'ForeName': 'Han-Suk', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, Korea (the Republic of).'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2021-321945']
618,34286370,Prostatic Artery Embolization Versus Transurethral Resection of the Prostate: A Post Hoc Cost Analysis of a Randomized Controlled Clinical Trial.,"PURPOSE


To perform a post hoc analysis of patient-incurred costs in a randomized controlled clinical trial comparing prostatic artery embolization (PAE) and transurethral resection of the prostate (TURP).
MATERIALS AND METHODS


Patients older than 60 years with indication of TURP were randomized to PAE or TURP procedure. After intervention and hospital discharge, patients were follow-up during 12 months The associated patient costs were categorized according to the study period: pre-intervention, intervention, hospitalization, and follow-up. Several items for both groups were analyzed within each study period.
RESULTS


The mean total costs per patient were lower for PAE (€ 3,192.87) than for TURP (€ 3,974.57), with this difference of € 781.70 being significant (p = 0.026). For most evaluated items, the mean costs were significantly higher for TURP. No significant differences were observed in the mean costs of PAE (€ 1,468.00) and TURP (€ 1,684.25) procedures (p = 0.061). However, the histopathology analysis, recovery room stay, and intraoperative laboratory analysis increased the interventional costs for TURP (€ 1,999.70) compared with PAE (€ 1,468.00) (p < 0.001). No cost differences were observed between PAE (€ 725.26) and TURP (€ 556.22) during the 12 months of follow-up (p = 0.605). None of patients required a repeat intervention during the study period.
CONCLUSIONS


Considering the short-term follow-up, PAE was associated with significantly lower costs compared with TURP. Future investigations in the context of routine clinical practice should be aimed at comparing the long-term effectiveness of both procedures and determining their cost-effectiveness.
LEVEL OF EVIDENCE


Level 1 (a-c).",2021,"The mean total costs per patient were lower for PAE (€ 3,192.87) than for TURP (€ 3,974.57), with this difference of € 781.70 being significant (p = 0.026).",['Patients older than 60\xa0years with indication of TURP'],"['prostatic artery embolization (PAE) and transurethral resection of the prostate (TURP', 'Prostatic Artery Embolization Versus Transurethral Resection of the Prostate', 'PAE or TURP procedure']","['mean costs of PAE', 'mean costs', 'histopathology analysis, recovery room stay, and intraoperative laboratory analysis increased the interventional costs for TURP', 'mean total costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0397760', 'cui_str': 'Embolization of artery'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0397760', 'cui_str': 'Embolization of artery'}, {'cui': 'C0243140', 'cui_str': 'histopathology'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0595259,"The mean total costs per patient were lower for PAE (€ 3,192.87) than for TURP (€ 3,974.57), with this difference of € 781.70 being significant (p = 0.026).","[{'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Capdevila', 'Affiliation': 'Complejo Hospitalario de Navarra, Calle Irunlarrea 3, 31008, Pamplona, Spain. fcapdevilabastons@gmail.com.'}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Insausti', 'Affiliation': 'Complejo Hospitalario de Navarra, Calle Irunlarrea 3, 31008, Pamplona, Spain.'}, {'ForeName': 'Arkaitz', 'Initials': 'A', 'LastName': 'Galbete', 'Affiliation': 'Complejo Hospitalario de Navarra, Calle Irunlarrea 3, 31008, Pamplona, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sanchez-Iriso', 'Affiliation': 'Universidad Pública de Navarra (UPNA), Campus de Arrosadia, s/n, 31006, Pamplona, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Montesino', 'Affiliation': 'Complejo Hospitalario de Navarra, Calle Irunlarrea 3, 31008, Pamplona, Spain.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-021-02920-3']
619,34267085,The Impact of Optimism and Pain Interference on Response to Online Behavioral Treatment for Mood and Anxiety Symptoms.,"OBJECTIVE


This study aimed to explore a) if high pain interference has a negative effect on response to computerized cognitive behavioral therapy (cCBT) for anxiety and depression and b) whether high optimism can buffer the negative effects of pain interference on cCBT outcomes.
METHODS


We performed a secondary analysis of data on 403 participants from the randomized controlled clinical trial ""Online Treatment for Mood and Anxiety Disorders in Primary Care."" It examined the impact of cCBT, with and without access to an Internet support group, on health-related quality of life (HRQoL), mood, and anxiety symptoms.
RESULTS


High versus low pain interference had a negative effect on response to cCBT for physical HRQoL regardless of high or low optimism level (between group difference = -3.46 [-5.89 to -1.03], p = .005, or -4.06 [-6.28 to -1.85], p < .001, respectively). However, in the context of low optimism/high pain interference only negatively impacted the effect of cCBT on mental HRQoL (3.68 [0.63 to 6.73], p = .018) and anxiety symptoms (-2.61 [-4.87 to -0.35], p = .024). Although the pattern of effects was similar for depressive symptoms, the between-group differences were not significant.
CONCLUSIONS


High optimism may buffer against the negative effects of pain interference on treatment response from cCBT. Primary care patients who report high pain interference yet also lack optimism may not receive as much benefit from cCBT as other groups. Furthermore, this study found an unexpected positive effect of low optimism on treatment response. For depressed and anxious patients with low pain interference, low optimism enhanced the impact of cCBT on mental HRQoL.Trial Registration:ClinicalTrials.gov Identifier: NCT01482806.",2021,"However, in the context of low optimism high pain interference only negatively impacted the effect of cCBT on mental HRQoL (3.68 (0.63, 6.73) p = 0.018) and anxiety symptoms (-2.61 (-4.87, -0.35) p = 0.024).","['403 participants from the randomized controlled clinical trial ""Online Treatment for Mood and Anxiety Disorders in Primary Care']",['computerized cognitive behavioral therapy (cCBT'],"['mental HRQoL', 'anxiety symptoms', 'health-related quality of life (HRQoL), mood, and anxiety symptoms', 'Mood and Anxiety Symptoms', 'depressive symptoms']","[{'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",403.0,0.0327649,"However, in the context of low optimism high pain interference only negatively impacted the effect of cCBT on mental HRQoL (3.68 (0.63, 6.73) p = 0.018) and anxiety symptoms (-2.61 (-4.87, -0.35) p = 0.024).","[{'ForeName': 'Natalia E', 'Initials': 'NE', 'LastName': 'Morone', 'Affiliation': 'From the Section of General Internal Medicine (Morone), Boston University School of Medicine, Boston Medical Center, Boston, Massachusetts; University of Pittsburgh Center for Behavioral Health, Media, and Technology, Division of General Internal Medicine (Belnap Herbeck, Rollman, Jonassaint), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; Department of Psychosomatic Medicine and Psychotherapy (Belnap Herbeck), University of Göttingen Medical Center, Göttingen, Germany; and Division of General Internal Medicine (Huang, Abebe), and Center for Research on Health Care Data Center, Division of General Internal Medicine (Abebe), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Bea Belnap', 'Initials': 'BB', 'LastName': 'Herbeck', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': ''}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Rollman', 'Affiliation': ''}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Jonassaint', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000980']
620,34265088,Time to onset of cannabidiol treatment effects in Dravet syndrome: Analysis from two randomized controlled trials.,"OBJECTIVE


We conducted a post hoc analysis of two randomized controlled trials, GWPCARE1 (NCT02091375) and GWPCARE2 (NCT02224703), to estimate the time to onset of cannabidiol (CBD) treatment effects (seizure reduction and adverse events [AEs]) in patients with Dravet syndrome (DS).
METHODS


Patients received either plant-derived highly purified CBD (Epidiolex in the United States; 100 mg/ml oral solution) 10 mg/kg/day (CBD10; GWPCARE2) or 20 mg/kg/day (CBD20; GWPCARE1&2), or matching placebo for 14 weeks. Treatment started at 2.5 mg/kg/day, reached 10 mg/kg/day on Day 7, and went up to 20 mg/kg/day on Day 11 during the 14-day titration period. Percentage change from baseline in convulsive seizure frequency was calculated by cumulative day (i.e., including all previous days). Time to onset and resolution of AEs were also evaluated.
RESULTS


Overall, 124 patients received placebo and 194 received CBD (CBD10, n = 64; CBD20, n = 130). Mean age was 9.5 years (range = 2.2-18.9). Patients had discontinued a median of four antiepileptic drugs (range = 0-26) and were currently taking a median of three (range = 1-5). Differences in convulsive seizure reduction between placebo and CBD emerged during titration and became nominally significant by Day 12 for CBD20 (p = .02) and Day 13 for CBD10 (p = .03). Additionally, differences in the 50% responder rate between placebo and CBD became apparent during titration. Onset of the first reported AE occurred during the titration period in 48.4% of placebo patients and 54.1% of CBD patients. The three most common AEs of somnolence, decreased appetite, and diarrhea resolved within 4 weeks of onset in the majority of CBD-treated patients (56.3%-72.9%).
SIGNIFICANCE


The therapeutic effect of CBD in DS may start within 2 weeks of treatment in some patients. Although AEs lasted longer for CBD than placebo, most resolved within the 14-week study period.",2021,Differences in convulsive seizure reduction between placebo and CBD emerged during titration and became nominally significant by Day 12 for CBD20 (p = .02) and Day 13 for CBD10 (p = .03).,"['Patients received either', 'Patients had discontinued a median of four antiepileptic drugs (range = 0-26) and were currently taking a median of three (range = 1-5', 'Mean age was 9.5\xa0years (range = 2.2-18.9', '124 patients received', 'Dravet syndrome', 'patients with Dravet syndrome (DS']","['placebo', 'plant-derived highly purified CBD (Epidiolex in the United States; 100\xa0mg/ml oral solution) 10\xa0mg/kg/day (CBD10; GWPCARE2) or 20\xa0mg/kg/day (CBD20; GWPCARE1&2), or matching placebo', 'CBD']","['convulsive seizure reduction', 'somnolence, decreased appetite, and diarrhea', 'convulsive seizure frequency', 'Time to onset and resolution of AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0751122', 'cui_str': 'Severe myoclonic epilepsy in infancy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C4731581', 'cui_str': 'Epidiolex'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0751494', 'cui_str': 'Seizures, Convulsive'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",,0.369243,Differences in convulsive seizure reduction between placebo and CBD emerged during titration and became nominally significant by Day 12 for CBD20 (p = .02) and Day 13 for CBD10 (p = .03).,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Madan Cohen', 'Affiliation': ""Department of Pediatrics, Division of Neurology at Connecticut Children's, University of Connecticut, Hartford, Connecticut, USA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Checketts', 'Affiliation': 'GW Research, Cambridge, UK.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Greenwich Biosciences, Carlsbad, California, USA.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'Gunning', 'Affiliation': 'Stichting Epilepsie Instellingen Nederland, Zwolle, the Netherlands.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hyslop', 'Affiliation': ""Nicklaus Children's Hospital, Miami, Florida, USA.""}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Madhavan', 'Affiliation': 'Boys Town National Research Hospital, Boys Town, Nebraska, USA.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Villanueva', 'Affiliation': 'University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Zolnowska', 'Affiliation': 'Medical Center Plejady, Krakow, Poland.'}, {'ForeName': 'Sameer M', 'Initials': 'SM', 'LastName': 'Zuberi', 'Affiliation': 'Paediatric Neurosciences Research Group, Royal Hospital for Children & College of Medical, Veterinary, and Life Sciences, University of Glasgow, Glasgow, UK.'}]",Epilepsia,['10.1111/epi.16974']
621,34275765,Effect of Tart Cherry on Aromatase Inhibitor-Induced Arthralgia (AIA) in Nonmetastatic Hormone-Positive Breast Cancer Patients: A Randomized Double-Blind Placebo-Controlled Trial.,"BACKGROUND


Aromatase Inhibitor induced Arthralgia (AIA) can cause noncompliance leading to decreased breast-cancer survival. Effective interventions for AIA are limited. Tart cherry (TC) showed beneficial effect on musculoskeletal pain. 48 patients (Pts) randomized to TC versus placebo over 6 weeks, TC (23pts) had 34.7% mean pain decrease versus 1.4% in Placebo (25pts). TC can improve AIA in nonmetastatic breast-cancer patients.
METHODS


Randomized, placebo-controlled, double-blind trial. Eligible patients with NMHPBC on AI for at least 4 weeks were randomized to TC concentrate [50 tart cherries] vs. placebo (P) [syrup] in 1:1 model. Patients instructed to consume 1 Oz of concentrate in 8 Oz water daily for 6 weeks, and document their pain intensity at baseline, weekly and at study completion in a diary using Visual Analog Scale (VAS), with 0 mm indicating no pain, and 100 mm indicating highest pain.
RESULTS


Sixty patients were enrolled. Two patients did not complete the study due to diarrhea, and 10 patients were noncompliant. Forty-eight patients were included in the final analysis. TC group (23 pts) had 34.7% mean decrease in pain compared to 1.4% in P group (25 pts). This difference was statistically significant (Mann-Whitney U Test, P = .034).
CONCLUSIONS


Tart cherry can significantly improve AIA in nonmetastatic breast cancer patient.",2022,TC group (23 pts) had 34.7% mean decrease in pain compared to 1.4% in P group (25 pts).,"['48 patients (Pts) randomized to', 'Sixty patients were enrolled', 'Nonmetastatic Hormone-Positive Breast Cancer Patients', 'Forty-eight patients were included in the final analysis', 'Eligible patients with NMHPBC on AI for at least 4 weeks', 'nonmetastatic breast cancer patient', 'nonmetastatic breast-cancer patients']","['TC concentrate [50 tart cherries] vs. placebo (P) [syrup', 'Tart Cherry', 'TC', 'Placebo', 'Tart cherry (TC', 'placebo', 'TC versus placebo']","['musculoskeletal pain', 'Aromatase Inhibitor-Induced Arthralgia (AIA', 'pain', 'mean pain decrease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0330657', 'cui_str': 'Prunus cerasus'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}]","[{'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",48.0,0.497838,TC group (23 pts) had 34.7% mean decrease in pain compared to 1.4% in P group (25 pts).,"[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Shenouda', 'Affiliation': 'Hematology Oncology Department, Marshall University, Joan C. Edwards School of Medicine, Edwards Comprehensive Cancer Center, Huntington, WV. Electronic address: mshenouda11@gmail.com.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Copley', 'Affiliation': 'Hematology Oncology Department, Marshall University, Joan C. Edwards School of Medicine, Edwards Comprehensive Cancer Center, Huntington, WV.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Pacioles', 'Affiliation': 'Hematology Oncology Department, Marshall University, Joan C. Edwards School of Medicine, Edwards Comprehensive Cancer Center, Huntington, WV.'}, {'ForeName': 'Yehuda', 'Initials': 'Y', 'LastName': 'Lebowicz', 'Affiliation': 'Hematology Oncology Department, Marshall University, Joan C. Edwards School of Medicine, Edwards Comprehensive Cancer Center, Huntington, WV; Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Jamil', 'Affiliation': 'Hematology Oncology Department, Marshall University, Joan C. Edwards School of Medicine, Edwards Comprehensive Cancer Center, Huntington, WV.'}, {'ForeName': 'Sutoidem', 'Initials': 'S', 'LastName': 'Akpanudo', 'Affiliation': 'Internal Medicine Department, Marshall University, Joan C. Edwards School of Medicine, Huntington, WV; Internal Medicine Department, Duke University, Durham, NC.'}, {'ForeName': 'Maria Tria', 'Initials': 'MT', 'LastName': 'Tirona', 'Affiliation': 'Hematology Oncology Department, Marshall University, Joan C. Edwards School of Medicine, Edwards Comprehensive Cancer Center, Huntington, WV.'}]",Clinical breast cancer,['10.1016/j.clbc.2021.06.007']
622,34280568,Infectious consequences of hematoma from cardiac implantable electronic device procedures and the role of the antibiotic envelope: A WRAP-IT trial analysis.,"BACKGROUND


Hematoma is a complication of cardiac implantable electronic device (CIED) procedures and may lead to device infection. The TYRX antibacterial envelope reduced major CIED infection by 40% in the randomized WRAP-IT (World-wide Randomized Antibiotic Envelope Infection Prevention Trial) study, but its effectiveness in the presence of hematoma is not well understood.
OBJECTIVE


The purpose of this study was to evaluate the incidence and infectious consequences of hematoma and the association between envelope use, hematomas, and major CIED infection among WRAP-IT patients.
METHODS


All 6800 study patients were included in this analysis (control 3429; envelope 3371). Hematomas occurring within 30 days postprocedure (acute) were characterized and grouped by study treatment and evaluated for subsequent infection risk. Data were analyzed using Cox proportional hazard regression modeling.
RESULTS


Acute hematoma incidence was 2.2% at 30 days, with no significant difference between treatment groups (envelope vs control hazard ratio [HR] 1.15; 95% confidence interval [CI] 0.84-1.58; P = .39). Through all follow-up, the risk of major infection was significantly higher among control patients with hematoma vs those without (13.1% vs 1.6%; HR 11.3; 95% CI 5.5-23.2; P <.001). The risk of major infection was significantly lower in the envelope vs control patients with hematoma (2.5% vs 13.1%; HR 0.18; 95% CI 0.04-0.85; P = .03).
CONCLUSION


The risk of hematoma was 2.2% among WRAP-IT patients. Among control patients, hematoma carried a >11-fold risk of developing a major CIED infection. This risk was significantly mitigated with antibacterial envelope use, with an 82% reduction in major CIED infection among envelope patients who developed hematoma compared to control.",2021,This risk was significantly mitigated with antibacterial envelope use as there was an 82% reduction in major CIED infection among envelope patients who developed hematoma compared to control.,"['WRAP-IT patients', 'All 6800 study patients were included in this analysis (control = 3429; envelope = 3371']",[],"['Acute hematoma incidence', 'risk of hematoma', 'major CIED infection', 'risk of major infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",6800.0,0.0665997,This risk was significantly mitigated with antibacterial envelope use as there was an 82% reduction in major CIED infection among envelope patients who developed hematoma compared to control.,"[{'ForeName': 'Khaldoun G', 'Initials': 'KG', 'LastName': 'Tarakji', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland Ohio. Electronic address: tarakjk@ccf.org.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Korantzopoulos', 'Affiliation': 'First Department of Cardiology, University Hospital of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Philippon', 'Affiliation': 'Electrophysiology Division, Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ), Québec, Canada.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Biffi', 'Affiliation': ""Institute of Cardiology, University of Bologna, Policlinico Sant' Orsola, Malpighi, Italy.""}, {'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Cardiology, Valley Health System, Ridgewood, New Jersey.'}, {'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'Division of Cardiology, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kennergren', 'Affiliation': 'First Department of Cardiology, University Hospital of Ioannina, Ioannina, Greece; Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Lexcen', 'Affiliation': 'Medtronic, Inc., Mounds View, Minnesota.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Lande', 'Affiliation': 'Medtronic, Inc., Mounds View, Minnesota.'}, {'ForeName': 'Swathi', 'Initials': 'S', 'LastName': 'Seshadri', 'Affiliation': 'Medtronic, Inc., Mounds View, Minnesota.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Wilkoff', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland Ohio.'}]",Heart rhythm,['10.1016/j.hrthm.2021.07.011']
623,34267857,A Phase I-II Basket Trial Design to Optimize Dose-Schedule Regimes Based on Delayed Outcomes.,"This paper proposes a Bayesian adaptive basket trial design to optimize the dose-schedule regimes of an experimental agent within disease subtypes, called ""baskets"", for phase I-II clinical trials based on late-onset efficacy and toxicity. To characterize the association among the baskets and regimes, a Bayesian hierarchical model is assumed that includes a heterogeneity parameter, adaptively updated during the trial, that quantifies information shared across baskets. To account for late-onset outcomes when doing sequential decision making, unobserved outcomes are treated as missing values and imputed by exploiting early biomarker and low-grade toxicity information. Elicited joint utilities of efficacy and toxicity are used for decision making. Patients are randomized adaptively to regimes while accounting for baskets, with randomization probabilities proportional to the posterior probability of achieving maximum utility. Simulations are presented to assess the design's robustness and ability to identify optimal dose-schedule regimes within disease subtypes, and to compare it to a simplified design that treats the subtypes independently.",2021,"Simulations are presented to assess the design's robustness and ability to identify optimal dose-schedule regimes within disease subtypes, and to compare it to a simplified design that treats the subtypes independently.",[],[],['Elicited joint utilities of efficacy and toxicity'],[],[],"[{'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.0465268,"Simulations are presented to assess the design's robustness and ability to identify optimal dose-schedule regimes within disease subtypes, and to compare it to a simplified design that treats the subtypes independently.","[{'ForeName': 'Ruitao', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas 77030, U.S.A.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Thall', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas 77030, U.S.A.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas 77030, U.S.A.'}]",Bayesian analysis,['10.1214/20-ba1205']
624,34275774,Tooth extractions in patients with cancer receiving high-dose antiresorptive medication: a randomized clinical feasibility trial of drug holiday versus drug continuation.,"OBJECTIVE


Medication-related osteonecrosis of the jaw (MRONJ) is a serious adverse reaction to high-dose antiresorptive medication (AR) in patients with cancer. A temporary discontinuation of AR (drug holiday) has been suggested to potentially reduce the risk of MRONJ after oral surgery. However, no consensus exists. The aim of the present feasibility trial was to evaluate the impact of a high-dose AR drug holiday in connection with surgical tooth extraction on the development of MRONJ and patient-reported health state.
STUDY DESIGN


Patients with cancer receiving high-dose AR were randomized to a drug holiday from 1 month before to 3 months after surgical tooth extraction or drug continuation. Follow-up was scheduled at 1, 3, and 6 months postoperatively. Patient health state was evaluated using the EQ-5D-5L questionnaire.
RESULTS


The study included 23 patients (11 men, 12 women). AR included denosumab (n = 13) and bisphosphonate (n = 10) with median AR durations of 9 and 17.5 months, respectively. Four denosumab patients from the drug holiday group developed MRONJ. Differences in EQ-5D-5L between the treatment groups were found in favor of drug continuation.
CONCLUSIONS


The results indicate that a high-dose AR drug holiday does not prevent development of MRONJ after surgical tooth extraction and that patient-reported health state declines during a drug holiday compared with drug continuation.",2022,"Differences in EQ-5D-5L between the treatment groups were found in favor of drug continuation.
","['23 patients (11 men, 12 women', 'Patients with cancer receiving high-dose AR', 'patients with cancer receiving high-dose antiresorptive medication', 'patients with cancer']","['bisphosphonate', 'denosumab']","['Patient health state', 'EQ-5D-5L']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}]",23.0,0.100203,"Differences in EQ-5D-5L between the treatment groups were found in favor of drug continuation.
","[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Ottesen', 'Affiliation': 'Research Area Oral Rehabilitation, Section for Oral Health, Society and Technology, Institute of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Department of Oral & Maxillofacial Surgery, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: camilla.ottesen@sund.ku.dk.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schiodt', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Simon Storgaard', 'Initials': 'SS', 'LastName': 'Jensen', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark; Research Area Oral Surgery, Section for Oral Biology and Immunopathology, Institute of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kofod', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Gotfredsen', 'Affiliation': 'Research Area Oral Rehabilitation, Section for Oral Health, Society and Technology, Institute of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2021.06.003']
625,34282506,Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair.,"INTRODUCTION


Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months.
METHODS


A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm 2 , scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months.
RESULTS


Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery.
CONCLUSION


After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations.
TRIAL REGISTRATION


Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.",2022,"After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients.","['Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10\xa0cm 2 , scheduled for elective repair, were included', 'VHWG grade 3 hernia repair', 'Eighty-four patients were treated with biosynthetic mesh']",[],"['hernia recurrence', 'quality of life or reduction of pain', 'manageable SSO rates and favorable recurrence rates', 'quality of life outcomes', '3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24\xa0months']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}]",[],"[{'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}]",84.0,0.169745,"After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients.","[{'ForeName': 'M M J', 'Initials': 'MMJ', 'LastName': 'Van Rooijen', 'Affiliation': 'Department of Surgery, Erasmus University Medical Centre Rotterdam, Room Ee-1453, PO BOX 2040, 3000 CA, Rotterdam, The Netherlands. m.vanrooijen@erasmusmc.nl.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tollens', 'Affiliation': 'Department of General Surgery, Imelda Hospital, Bonheiden, Belgium.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Surgery, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'de Vries Reilingh', 'Affiliation': 'Department of Surgery, Elkerliek Hospital, Helmond, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'Department of Surgery, University Hospital Lille, Lille, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Köckerling', 'Affiliation': 'Department of Surgery, Vivantes Klinikum Spandau, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miserez', 'Affiliation': 'Department of Abdominal Surgery, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'A C J', 'Initials': 'ACJ', 'LastName': 'Windsor', 'Affiliation': 'Department of Colorectal Surgery, University College London Hospital, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Berrevoet', 'Affiliation': 'Department of General and Hepatobiliary Surgery, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Fortelny', 'Affiliation': 'Department of General, Visceral and Oncologic Surgery, Wilhelminen Hospital, Vienna, Austria.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Dousset', 'Affiliation': 'Department of Digestive, Hepatobiliary and Endocrine Surgery, Hôpital Cochin, Paris, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Woeste', 'Affiliation': 'Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt am Main, Germany.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'van Westreenen', 'Affiliation': 'Department of Surgery, Isala Zwolle, Zwolle, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gossetti', 'Affiliation': 'Università di Roma Sapienza, Rome, Italy.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Lange', 'Affiliation': 'Department of Surgery, Erasmus University Medical Centre Rotterdam, Room Ee-1453, PO BOX 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'G W M', 'Initials': 'GWM', 'LastName': 'Tetteroo', 'Affiliation': 'Department of Surgery, IJsselland Ziekenhuis, Capelle aan den Ijssel, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Chirurgische Praxis Cottbus, Cottbus, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jeekel', 'Affiliation': 'Department of Neuroscience, Erasmus University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-021-02453-1']
626,34275593,"Randomized, Placebo-Controlled Trial of the Angiotensin Receptor Antagonist Losartan for Posttraumatic Stress Disorder.","BACKGROUND


Evidence-based pharmacological treatments for posttraumatic stress disorder (PTSD) are few and of limited efficacy. Previous work suggests that angiotensin type 1 receptor inhibition facilitates fear inhibition and extinction, important for recovery from PTSD. This study tests the efficacy of the angiotensin type 1 receptor antagonist losartan, an antihypertensive drug, repurposed for the treatment of PTSD.
METHODS


A randomized controlled trial was conducted for 10 weeks in 149 men and women meeting DSM-5 PTSD criteria. Losartan (vs. placebo) was flexibly titrated from 25 to 100 mg/day by week 6 and held at highest tolerated dose until week 10. Primary outcome was the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) change score at 10 weeks from baseline. A key secondary outcome was change in CAPS-5 associated with a single nucleotide polymorphism of the ACE gene. Additional secondary outcomes included changes in the PTSD Checklist for DSM-5 and the Patient Health Questionnaire-9, and proportion of responders with a Clinical Global Impressions-Improvement scale of ""much improved"" or ""very much improved.""
RESULTS


Both groups had robust improvement in PTSD symptoms, but there was no significant difference on the primary end point, CAPS-5 measured as week 10 change from baseline, between losartan and placebo (mean change difference, 0.9, 95% confidence interval, -3.2 to 5.0). There was no significant difference in the proportion of Clinical Global Impressions-Improvement scale responders for losartan (58.6%) versus placebo (57.9%), no significant differences in changes in PTSD Checklist for DSM-5 or Patient Health Questionnaire-9, and no association between ACE genotype and CAPS-5 improvement on losartan.
CONCLUSIONS


At these doses and durations, there was no significant benefit of losartan compared with placebo for the treatment of PTSD. We discuss implications for failure to determine the benefit of a repurposed drug with strong a priori expectations of success based on preclinical and epidemiological data.",2021,"Both groups had robust improvement in PTSD symptoms, but there was no significant difference on the primary end point, CAPS-5 measured as week 10 change from baseline, between losartan and placebo (mean change difference, 0.9, 95% confidence interval, -3.2 to 5.0).","['10 weeks in 149 men and women meeting DSM-5 PTSD criteria', 'Posttraumatic Stress Disorder', 'posttraumatic stress disorder (PTSD']","['losartan', 'Losartan (vs. placebo', 'angiotensin type 1 receptor antagonist losartan', 'Placebo', 'placebo', 'Angiotensin Receptor Antagonist Losartan']","['proportion of Clinical Global Impressions-Improvement scale responders', 'CAPS-5', 'PTSD Checklist for DSM-5 and the Patient Health Questionnaire-9, and proportion of responders with a Clinical Global Impressions-Improvement scale of ""much improved"" or ""very much improved', 'Clinician-Administered PTSD Scale for DSM-5', 'PTSD symptoms', 'PTSD Checklist for DSM-5 or Patient Health Questionnaire-9']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0529330', 'cui_str': 'Angiotensin Type 1 Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0442824', 'cui_str': 'Very'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",149.0,0.410183,"Both groups had robust improvement in PTSD symptoms, but there was no significant difference on the primary end point, CAPS-5 measured as week 10 change from baseline, between losartan and placebo (mean change difference, 0.9, 95% confidence interval, -3.2 to 5.0).","[{'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, California; Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, La Jolla, California; VA San Diego Healthcare System, San Diego, California. Electronic address: mstein@health.ucsd.edu.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'NYU Grossman School of Medicine and NYU Langone Health, New York, New York.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'West', 'Affiliation': 'Uniformed Services University of the Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Marvar', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bui', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, La Jolla, California.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Benedek', 'Affiliation': 'Uniformed Services University of the Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Cassano', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Griffith', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Howlett', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, California; VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Malgaroli', 'Affiliation': 'NYU Grossman School of Medicine and NYU Langone Health, New York, New York.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Melaragno', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Antonia V', 'Initials': 'AV', 'LastName': 'Seligowski', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'I-Wei', 'Initials': 'IW', 'LastName': 'Shu', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, California; VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Szuhany', 'Affiliation': 'NYU Grossman School of Medicine and NYU Langone Health, New York, New York.'}, {'ForeName': 'Charles T', 'Initials': 'CT', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Ressler', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; McLean Hospital, Belmont, Massachusetts. Electronic address: kressler@mclean.harvard.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Biological psychiatry,['10.1016/j.biopsych.2021.05.012']
627,34284006,Short-term Efficacy and Mechanism of Electrical Pudendal Nerve Stimulation Versus Pelvic Floor Muscle Training Plus Transanal Electrical Stimulation in Treating Post-radical Prostatectomy Urinary Incontinence.,"OBJECTIVE


To assess the short-term efficacy of electrical pudendal nerve stimulation (EPNS) versus pelvic floor muscle training (PFMT) plus transanal electrical stimulation (TES) for the early treatment of post-radical prostatectomy urinary incontinence (PRPUI) and explore its mechanism of action.
SUBJECTS AND METHODS


A parallel designed randomized controlled trial was conducted at a research institute and a university hospital. Ninety-six PRPUI patients were allocated to EPNS group (64 cases) and PFMT+TES group (32 cases) and treated by EPNS and biofeedback-assisted PFMT plus TES, 3 times a week for 8 weeks, respectively. Outcome measurements were improvement rate, scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the number of used diapers.
RESULTS


After 24 treatments, the efficacy rate of 68.7% in EPNS group was significantly higher than that of 34.4% in PFMT+TES group (P=0.005). The ICIQ-UI SF score, and urine leakage amount score, diaper score, symptom and quality of life improved significantly in both groups and showed Therapy x Treatment interaction, and the above scores in EPNS group were significantly lower than these in PFMT+TES group. Perineal ultrasonographic recordings showed that PFM movement amplitude during EPNS (≥1- <3 mm) was similar to that during PFMT, however, PFM movement EMG amplitude was significantly higher during EPNS than during PFMT (P <0.001).
CONCLUSION


EPNS is more effective than PFMT+TES in short-term (8 weeks) treatments of early urinary incontinence after radical prostatectomy. Its mechanism of action is that EPNS can excite the pudendal nerve and simulate PFMT.",2022,"After 24 treatments, the efficacy rate of 68.7% in EPNS group was significantly higher than that of 34.4% in PFMT+TES group (P=0.005).","['treating post-radical prostatectomy urinary incontinence', 'Ninety-six PRPUI patients', 'post-radical prostatectomy urinary incontinence (PRPUI']","['EPNS', 'electrical pudendal nerve stimulation (EPNS) versus pelvic floor muscle training (PFMT) plus transanal electrical stimulation (TES', 'EPNS and biofeedback-assisted PFMT plus TES', 'electrical pudendal nerve stimulation versus pelvic floor muscle training plus transanal electrical stimulation']","['PFM movement EMG amplitude', 'ICIQ-UI SF score, and urine leakage amount score, diaper score, symptom and quality of life', 'PFM movement amplitude', 'improvement rate, scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the number of used diapers', 'efficacy rate']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0228959', 'cui_str': 'Structure of pudendal nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C1868598', 'cui_str': 'Enlarged parietal foramina'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0152245', 'cui_str': 'Extravasation of urine'}, {'cui': 'C0180416', 'cui_str': 'Diaper'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4544471', 'cui_str': 'International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",96.0,0.0435141,"After 24 treatments, the efficacy rate of 68.7% in EPNS group was significantly higher than that of 34.4% in PFMT+TES group (P=0.005).","[{'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Clinical Research Section, Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China; Shanghai University of Traditional Chinese MedicineYueyang Hospital of Traditional Chineseand Western Medicine, Shanghai, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': 'Department of Urology, Shanghai Jiaotong University School of Medicine Renji Hospital, Shanghai, China.'}, {'ForeName': 'Meixian', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Shanghai University of Traditional Chinese MedicineYueyang Hospital of Traditional Chineseand Western Medicine, Shanghai, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Lv', 'Affiliation': 'Department of Urology, Shanghai Jiaotong University School of Medicine Renji Hospital, Shanghai, China.'}, {'ForeName': 'Siyou', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Clinical Research Section, Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China; Shanghai University of Traditional Chinese MedicineYueyang Hospital of Traditional Chineseand Western Medicine, Shanghai, China. Electronic address: wangsiyou1234@163.com.'}]",Urology,['10.1016/j.urology.2021.04.069']
628,34288280,"Effectiveness of mindfulness-based stress reduction and attachment-based compassion therapy for the treatment of depressive, anxious, and adjustment disorders in mental health settings: A randomized controlled trial.","OBJECTIVES


To study the effectiveness of attachment-based compassion therapy (ABCT) for reducing affective distress in a sample of outpatients with depressive, anxiety, or adjustment disorders, and to explore its mechanisms of action.
METHODS


This randomized controlled trial involved the assessment time points of pretreatment, posttreatment and 6-month follow-up. A total of 90 patients from three mental health units in Castellón, Spain, were recruited and randomly assigned to ""ABCT + treatment as usual (TAU),"" ""Mindfulness-based stress reduction (MBSR) + TAU"" or ""TAU"" alone. Affective distress, as measured by the ""Depression, Anxiety and Stress Scales"" (DASS-21) was the main outcome; self-compassion and mindfulness were also assessed. Multilevel mixed-effects models were used to estimate the effectiveness of the program, and path analyses were conducted to study the potential mechanistic role of mindfulness and self-compassion.
RESULTS


ABCT was not superior to MBSR in any outcome or at any assessment point. ABCT was superior to TAU alone both posttreatment (B = -13.20; 95% confidence interval [CI]: -19.57, -6.84) and at 6-month follow-up (B = -7.20; 95% CI: -13.63, -0.76) for reducing DASS-21, and MBSR was superior to TAU alone both posttreatment (B = -11.51; 95% CI: -17.97, -5.05) and at 6-month follow-up (B = -8.59; 95% CI: -15.09, -2.10), with large effects (d ≥ 0.90). Changes produced by ABCT in DASS-21 were mediated by self-compassion, whereas changes produced by MBSR were mediated by both mindfulness and self-compassion.
CONCLUSION


ABCT is effective for reducing affective distress in patients with anxiety, depressive and adjustment disorders, although its effect is not superior to that offered by MBSR. Self-compassion seems to be a significant mediator of the effects of ABCT.",2021,"ABCT was superior to TAU alone both posttreatment (B = -13.20; 95% confidence interval [CI]: -19.57, -6.84) and at 6-month follow-up (B = -7.20; 95% CI: -13.63, -0.76) for reducing DASS-21, and MBSR was superior to TAU alone both posttreatment (B = -11.51; 95% CI: -17.97, -5.05) and at 6-month follow-up (B = -8.59; 95% CI: -15.09, -2.10), with large effects (d ≥ 0.90).","['patients with anxiety, depressive and adjustment disorders', '90 patients from three mental health units in Castellón, Spain', 'depressive, anxious, and adjustment disorders in mental health settings', 'outpatients with depressive, anxiety, or adjustment disorders']","['mindfulness-based stress reduction and attachment-based compassion therapy', 'ABCT', 'ABCT\u2009+\u2009treatment as usual (TAU),"" ""Mindfulness-based stress reduction (MBSR)\u2009+\u2009TAU"" or ""TAU"" alone', 'attachment-based compassion therapy (ABCT']","['Affective distress', 'DASS-21, and MBSR', 'Depression, Anxiety and Stress Scales"" (DASS-21', 'affective distress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001546', 'cui_str': 'Adjustment disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",90.0,0.0435043,"ABCT was superior to TAU alone both posttreatment (B = -13.20; 95% confidence interval [CI]: -19.57, -6.84) and at 6-month follow-up (B = -7.20; 95% CI: -13.63, -0.76) for reducing DASS-21, and MBSR was superior to TAU alone both posttreatment (B = -11.51; 95% CI: -17.97, -5.05) and at 6-month follow-up (B = -8.59; 95% CI: -15.09, -2.10), with large effects (d ≥ 0.90).","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Collado-Navarro', 'Affiliation': 'Department of Psychology, University and Polytechnic La Fe Hospital, Valencia, Spain.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Navarro-Gil', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Pérez-Aranda', 'Affiliation': 'Research Group on Mental Health in Primary Care, Institute of Health Research of Aragon (IIS Aragón), Miguel Servet University Hospital, Zaragoza, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'López-Del-Hoyo', 'Affiliation': 'Department of Psychology and Sociology, Department of Psychiatry, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Garcia-Campayo', 'Affiliation': 'Department of Psychology and Sociology, Department of Psychiatry, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Montero-Marin', 'Affiliation': 'Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK.'}]",Depression and anxiety,['10.1002/da.23198']
629,34292205,Noninvasive Cervical Vagal Nerve Stimulation Alters Brain Activity During Traumatic Stress in Individuals With Posttraumatic Stress Disorder.,"OBJECTIVE


Posttraumatic stress disorder (PTSD) is a disabling condition affecting a large segment of the population; however, current treatment options have limitations. New interventions that target the neurobiological alterations underlying symptoms of PTSD could be highly beneficial. Transcutaneous cervical (neck) vagal nerve stimulation (tcVNS) has the potential to represent such an intervention. The goal of this study was to determine the effects of tcVNS on neural responses to reminders of traumatic stress in PTSD.
METHODS


Twenty-two participants were randomized to receive either sham (n = 11) or active (n = 11) tcVNS stimulation in conjunction with exposure to neutral and personalized traumatic stress scripts with high-resolution positron emission tomography scanning with radiolabeled water for brain blood flow measurements.
RESULTS


Compared with sham, tcVNS increased brain activations during trauma scripts (p < .005) within the bilateral frontal and temporal lobes, left hippocampus, posterior cingulate, and anterior cingulate (dorsal and pregenual), and right postcentral gyrus. Greater deactivations (p < .005) with tcVNS were observed within the bilateral frontal and parietal lobes and left thalamus. Compared with tcVNS, sham elicited greater activations (p < .005) in the bilateral frontal lobe, left precentral gyrus, precuneus, and thalamus, and right temporal and parietal lobes, hippocampus, insula, and posterior cingulate. Greater (p < .005) deactivations were observed with sham in the right temporal lobe, posterior cingulate, hippocampus, left anterior cingulate, and bilateral cerebellum.
CONCLUSIONS


tcVNS increased anterior cingulate and hippocampus activation during trauma scripts, potentially indicating a reversal of neurobiological changes with PTSD consistent with improved autonomic control.Trial Registration: No. NCT02992899.",2021,"Compared to tcVNS, sham elicited greater activations (p < 0.005) in the bilateral frontal lobe, left precentral gyrus, precuneus, and thalamus, and right temporal and parietal lobes, hippocampus, insula, and posterior cingulate.","['Twenty-two participants', 'Posttraumatic stress disorder (PTSD', 'Individuals with Posttraumatic Stress Disorder']","['Invasive Cervical Vagal Nerve Stimulation Alters Brain Activity', 'Transcutaneous cervical (neck) vagal nerve stimulation (tcVNS', 'tcVNS', 'active (n = 11) tcVNS stimulation in conjunction with exposure to neutral and personalized traumatic stress scripts with High-Resolution Positron Emission Tomography scanning with radiolabeled water for brain blood flow measurements']","['brain activations', 'anterior cingulate and hippocampus activation', 'bilateral frontal and temporal lobes, left hippocampus, posterior cingulate, and anterior cingulate (dorsal and pregenual), and right postcentral gyrus', 'Greater deactivations', 'bilateral frontal lobe, left precentral gyrus, precuneus, and thalamus, and right temporal and parietal lobes, hippocampus, insula, and posterior cingulate']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005776', 'cui_str': 'Circulatory function tests'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152302', 'cui_str': 'Structure of postcentral gyrus'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0152299', 'cui_str': 'Structure of ascending frontal gyrus'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}]",22.0,0.0996097,"Compared to tcVNS, sham elicited greater activations (p < 0.005) in the bilateral frontal lobe, left precentral gyrus, precuneus, and thalamus, and right temporal and parietal lobes, hippocampus, insula, and posterior cingulate.","[{'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wittbrodt', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences (Wittbrodt, Bremner), Emory University School of Medicine; School of Electrical and Computer Engineering (Gurel, Shandhi, Gazi, Inan), Georgia Institute of Technology; Department of Radiology (Nye) and Imaging Sciences, Emory University School of Medicine; Department of Epidemiology (Shah, Pearce, Murrah, Shallenberger, Vaccarino), Rollins School of Public Health, Emory University; Division of Cardiology, Department of Medicine (Shah, Vaccarino), Emory University School of Medicine, Atlanta; Atlanta VA Medical Center (Shah, Bremner), Decatur; Department of Biostatistics and Bioinformatics, Rollins School of Public Health (Ko), Emory University; and Wallace H. Coulter Department of Biomedical Engineering (Inan), Georgia Institute of Technology, Atlanta, Georgia.'}, {'ForeName': 'Nil Z', 'Initials': 'NZ', 'LastName': 'Gurel', 'Affiliation': ''}, {'ForeName': 'Jonathon A', 'Initials': 'JA', 'LastName': 'Nye', 'Affiliation': ''}, {'ForeName': 'Md Mobashir H', 'Initials': 'MMH', 'LastName': 'Shandhi', 'Affiliation': ''}, {'ForeName': 'Asim H', 'Initials': 'AH', 'LastName': 'Gazi', 'Affiliation': ''}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Pearce', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Murrah', 'Affiliation': ''}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'Lucy H', 'Initials': 'LH', 'LastName': 'Shallenberger', 'Affiliation': ''}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': ''}, {'ForeName': 'Omer T', 'Initials': 'OT', 'LastName': 'Inan', 'Affiliation': ''}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Bremner', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000987']
630,34292474,Intensive Blood Pressure Lowering and DWI Lesions in Intracerebral Hemorrhage: Exploratory Analysis of the ATACH-2 Randomized Trial.,"BACKGROUND


With the increasing use of magnetic resonance imaging in the assessment of acute intracerebral hemorrhage, diffusion-weighted imaging hyperintense lesions have been recognized to occur at sites remote to the hematoma in up to 40% of patients. We investigated whether blood pressure reduction was associated with diffusion-weighted imaging hyperintense lesions in acute intracerebral hemorrhage and whether such lesions are associated with worse clinical outcomes by analyzing imaging data from a randomized trial.
METHODS


We performed exploratory subgroup analyses in an open-label randomized trial that investigated acute blood pressure lowering in 1000 patients with intracerebral hemorrhage between May 2011 and September 2015. Eligible participants were assigned to an intensive systolic blood pressure target of 110-139 mm Hg versus 140-179 mm Hg with the use of intravenous nicardipine. Of these, 171 patients had requisite magnetic resonance imaging sequences for inclusion in these subgroup analyses. The primary outcome was the presence of diffusion-weighted imaging hyperintense lesions. Secondary outcomes included death or disability and serious adverse event at 90 days.
RESULTS


Diffusion-weighted imaging hyperintense lesions were present in 25% of patients (mean age 62 years). Hematoma volume > 30 cm 3  was an adjusted predictor (adjusted relative risk 2.41, 95% confidence interval 1.00-5.80) of lesion presence. Lesions occurred in 25% of intensively treated patients and 24% of standard treatment patients (relative risk 1.01, 95% confidence interval 0.71-1.43, p = 0.97). Patients with diffusion-weighted imaging hyperintense lesions had similar frequencies of death or disability at 90 days, compared with patients without lesions.
CONCLUSIONS


Randomized assignment to intensive acute blood pressure lowering did not result in a greater frequency of diffusion-weighted imaging hyperintense lesion. Alternative mechanisms of diffusion-weighted imaging hyperintense lesion formation other than hemodynamic fluctuations need to be explored. Clinical trial registration ClinicalTrials.gov (Ref. NCT01176565; https://clinicaltrials.gov/ct2/show/NCT01176565 ).",2022,"Hematoma volume > 30 cm 3  was an adjusted predictor (adjusted relative risk 2.41, 95% confidence interval 1.00-5.80) of lesion presence.","['Eligible participants were assigned to an intensive systolic blood pressure target of 110-139\xa0mm Hg versus 140-179\xa0mm Hg with the use of intravenous', 'Intracerebral Hemorrhage', '171 patients had requisite magnetic resonance imaging sequences for inclusion in these subgroup analyses', '1000 patients with intracerebral hemorrhage between May 2011 and September 2015']","['nicardipine', 'Intensive Blood Pressure Lowering and DWI Lesions', 'magnetic resonance imaging']","['death or disability and serious adverse event at 90\xa0days', 'Lesions', 'presence of diffusion-weighted imaging hyperintense lesions', 'blood pressure reduction', 'death or disability']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0028005', 'cui_str': 'Nicardipine'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0598801', 'cui_str': 'Diffusion weighted magnetic resonance imaging'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",1000.0,0.302709,"Hematoma volume > 30 cm 3  was an adjusted predictor (adjusted relative risk 2.41, 95% confidence interval 1.00-5.80) of lesion presence.","[{'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'Division of Neurology, Department of Medicine, McMaster University / Population Health Research Institute, Hamilton, ON, Canada. ashkan.shoamanesh@phri.ca.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Cassarly', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Morotti', 'Affiliation': 'Stroke Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Javier M', 'Initials': 'JM', 'LastName': 'Romero', 'Affiliation': 'Department of Neurology J. P. Kistler Stroke Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jamary', 'Initials': 'J', 'LastName': 'Oliveira-Filho', 'Affiliation': 'Department of Neurology J. P. Kistler Stroke Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Frieder', 'Initials': 'F', 'LastName': 'Schlunk', 'Affiliation': 'Department of Neurology J. P. Kistler Stroke Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jessel', 'Affiliation': 'Department of Neurology J. P. Kistler Stroke Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Butcher', 'Affiliation': 'Department of Neurology, University of South Wales, Sydney, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gioia', 'Affiliation': ""Department of Neurology, Centre hospitalier de l'Université de Montréal (CHUM), Montréal, QC, Canada.""}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Ayres', 'Affiliation': 'Department of Neurology J. P. Kistler Stroke Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Vashkevich', 'Affiliation': 'Department of Neurology J. P. Kistler Stroke Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Schwab', 'Affiliation': 'Department of Neurology J. P. Kistler Stroke Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mohammad Rauf', 'Initials': 'MR', 'LastName': 'Afzal', 'Affiliation': 'Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Renee H', 'Initials': 'RH', 'LastName': 'Martin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Greenberg', 'Affiliation': 'Department of Neurology J. P. Kistler Stroke Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosand', 'Affiliation': 'Department of Neurology J. P. Kistler Stroke Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Goldstein', 'Affiliation': 'Department of Neurology J. P. Kistler Stroke Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurocritical care,['10.1007/s12028-021-01254-9']
631,34289086,"Difamilast, a selective phosphodiesterase 4 inhibitor, ointment in paediatric patients with atopic dermatitis: a phase III randomized double-blind, vehicle-controlled trial.","BACKGROUND


In atopic dermatitis (AD), phosphodiesterase 4 (PDE4) inhibition reduces proinflammatory mediators and cytokines. Difamilast is a new selective PDE4 inhibitor.
OBJECTIVES


To demonstrate the superiority of topical difamilast to vehicle in Japanese paediatric patients with AD.
METHODS


This was a phase III randomized, double-blind, vehicle-controlled trial. Patients aged 2-14 years with an Investigator Global Assessment (IGA) score of 2 or 3 received difamilast 0·3% (n = 83), difamilast 1% (n = 85) or vehicle (n = 83) ointment twice daily for 4 weeks.
RESULTS


The primary endpoint was the percentage of patients with an IGA score of 0 or 1 with improvement by at least two grades at week 4. The success rates in IGA score at week 4 were 44·6%, 47·1% and 18·1% in the difamilast 0·3%, difamilast 1% and vehicle groups, respectively. Both difamilast groups demonstrated significantly higher success rates in IGA score compared with vehicle at week 4 [difamilast 0·3% (P < 0·001); difamilast 1% (P < 0·001)]. Regarding secondary endpoints, improvements in Eczema Area and Severity Index (EASI; improvement of ≥ 50%, ≥ 75% and ≥ 90% in overall score) at week 4 were significantly higher in patients in the difamilast 0·3% and 1% groups than those in the vehicle group. EASI score in the difamilast 0·3% and 1% groups was significantly reduced compared with that of patients in the vehicle group at week 1. The significant difference between both the difamilast groups and the vehicle groups was maintained from week 1 through to week 4. Most treatment-emergent adverse events were mild or moderate, and no serious events or deaths were reported.
CONCLUSIONS


Difamilast 0·3% and 1% ointments are superior to vehicle and well tolerated in Japanese paediatric patients with AD.",2022,"Both difamilast groups demonstrated significantly higher success rates in IGA score versus vehicle at week 4 (difamilast 0·3%, P = 0·0005; difamilast 1%, P < 0·0001).","['Patients aged 2-14 years with an Investigator Global Assessment (IGA) score of 2 or 3 received difamilast 0·3% (n = 83), difamilast 1% (n = 85) or vehicle (n = 83', 'paediatric patients with atopic dermatitis', 'Japanese paediatric patients with AD']",['ointment twice daily for 4 weeks'],"['EASI score', 'success rate in IGA score', 'success rates in Eczema Area and Severity Index (EASI) 50, EASI 75 and EASI 90', 'success rates in IGA score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",,0.710747,"Both difamilast groups demonstrated significantly higher success rates in IGA score versus vehicle at week 4 (difamilast 0·3%, P = 0·0005; difamilast 1%, P < 0·0001).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Saeki', 'Affiliation': 'Department of Dermatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Baba', 'Affiliation': ""Department of Dermatology, Kanagawa Children's Medical Center, Kanagawa, Japan.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd, Osaka, Japan.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Yokota', 'Affiliation': 'Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd, Osaka, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tsubouchi', 'Affiliation': 'Medical Affairs, Otsuka Pharmaceutical Co., Ltd, Osaka, Japan.'}]",The British journal of dermatology,['10.1111/bjd.20655']
632,34292199,"Comparative Analysis of Pain, Muscle Strength, Disability, and Quality of Life in Middle-Aged and Older Adults After Web Video Lower Back Exercise.","This study analyzed the effect of lower back exercise using Web for each age group to use it as nursing intervention. We conducted a randomized experiment with 54 patients with low back pain, composed of 26 middle-aged and 28 older adult people with low back pain who visited a joint center. The participants were instructed to perform the exercise at least twice a day, four times a week. Pain, muscle strength, disability, and quality of life were measured before the exercise intervention, and data were collected again 8 weeks after. The data were analyzed using independent t tests, χ2test, Fisher's exact tests, repeated measures analysis of variance, and paired t tests. The middle-aged and older groups showed differences in pain, muscle strength, disability, and quality of life before and after exercise. In particular, the older group showed statistically significantly larger differences in quality of life compared with the middle-aged group. The results indicated that the effects of the lower back exercises, performed using the Web-based videos, were the same for both the middle-aged and older groups, whereas quality of life showed better improvement in the latter than in the former group. For elderly patients, exercise intervention is an appropriate nursing care to improve the quality of life.",2021,"The middle-aged and older groups showed differences in pain, muscle strength, disability, and quality of life before and after exercise.","['Middle-Aged and Older Adults', '54 patients with low back pain, composed of 26 middle-aged and 28 older adult people with low back pain who visited a joint center']","['lower back exercise', 'exercise intervention']","['Pain, Muscle Strength, Disability, and Quality of Life', 'quality of life', 'pain, muscle strength, disability, and quality of life', 'Pain, muscle strength, disability, and quality of life']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0454348', 'cui_str': 'Back exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",54.0,0.0159305,"The middle-aged and older groups showed differences in pain, muscle strength, disability, and quality of life before and after exercise.","[{'ForeName': 'Kyung Hye', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': ""Author Affiliations: Chonnam National University Bitgoel Hospital, The Doctor's Course of Nursing, College of Medicine, Chosun University (Ms Park), Gwangju; and College of Nursing, Gachon University (Dr Song), Incheon, South Korea.""}, {'ForeName': 'Mi Ryeong', 'Initials': 'MR', 'LastName': 'Song', 'Affiliation': ''}]","Computers, informatics, nursing : CIN",['10.1097/CIN.0000000000000801']
633,34292050,"Reappraising stress arousal improves affective, neuroendocrine, and academic performance outcomes in community college classrooms.","The field experiment presented here applied a stress regulation technique to optimize affective and neuroendocrine responses and improve academic and psychological outcomes in an evaluative academic context. Community college students (N = 339) were randomly assigned to stress reappraisal or active control conditions immediately before taking their second in-class exam. Whereas stress is typically perceived as having negative effects, stress reappraisal informs individuals about the functional benefits of stress and is hypothesized to reduce threat appraisals, and subsequently, improve downstream outcomes. Multilevel models indicated that compared with controls, reappraising stress led to less math evaluation anxiety, lower threat appraisals, more adaptive neuroendocrine responses (lower cortisol and higher testosterone levels on testing days relative to baseline), and higher scores on Exam 2 and on a subsequent Exam 3. Reappraisal students also persisted in their courses at a higher rate than controls. Targeted mediation models suggested stress appraisals partially mediated effects of reappraisal. Notably, procrastination and performance approach goals (measured between exams) partially mediated lagged effects of reappraisal on subsequent performance. Implications for the stress, emotion regulation, and mindsets literatures are discussed. Moreover, alleviating negative effects of acute stress in community college students, a substantial but understudied population, has potentially important applied implications. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,"Multilevel models indicated that compared with controls, reappraising stress led to less math evaluation anxiety, lower threat appraisals, more adaptive neuroendocrine responses (lower cortisol and higher testosterone levels on testing days relative to baseline), and higher scores on Exam 2 and on a subsequent Exam 3.","['Community college students (N = 339', 'community college classrooms', 'community college students']",['stress reappraisal or active control conditions immediately before taking their second in-class exam'],"['math evaluation anxiety, lower threat appraisals, more adaptive neuroendocrine responses (lower cortisol and higher testosterone levels', 'affective, neuroendocrine, and academic performance outcomes']","[{'cui': 'C0557812', 'cui_str': 'Community college'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]","[{'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0740379', 'cui_str': 'Cortisol decreased'}, {'cui': 'C0241358', 'cui_str': 'Testosterone increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",339.0,0.0483338,"Multilevel models indicated that compared with controls, reappraising stress led to less math evaluation anxiety, lower threat appraisals, more adaptive neuroendocrine responses (lower cortisol and higher testosterone levels on testing days relative to baseline), and higher scores on Exam 2 and on a subsequent Exam 3.","[{'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Jamieson', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Black', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Libbey E', 'Initials': 'LE', 'LastName': 'Pelaia', 'Affiliation': 'Department of Mathematics.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Gravelding', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Gordils', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Harry T', 'Initials': 'HT', 'LastName': 'Reis', 'Affiliation': 'Department of Psychology.'}]",Journal of experimental psychology. General,['10.1037/xge0000893']
634,34297008,Direct Verbal Suggestibility as a Predictor of Placebo Hypoalgesia Responsiveness.,"OBJECTIVE


Reliably identifying good placebo responders has pronounced implications for basic research on, and clinical applications of, the placebo response. Multiple studies point to direct verbal suggestibility as a potentially valuable predictor of individual differences in placebo responsiveness, but previous research has produced conflicting results on this association.
METHODS


In two double-blind studies, we examined whether behavioral direct verbal suggestibility measures involving a correction for compliance would be associated with individual differences in responsiveness to conditioned and unconditioned placebo hypoalgesia using an established placebo analgesia paradigm. In study 1 (n = 57; mean [standard deviation] age = 23.7 [8.1] years; 77% women), we used behavioral hypnotic suggestibility as a predictor of placebo hypoalgesia induced through conditioning and verbal suggestion, whereas in study 2 (n = 78; mean [standard deviation] = 26.1 [7.4] years; 65% women), we measured nonhypnotic suggestibility and placebo hypoalgesia induced through verbal suggestion without conditioning.
RESULTS


In study 1, the placebo hypoalgesia procedure yielded a moderate placebo response (g = 0.63 [95% confidence interval = 0.32 to 0.97]), but the response magnitude did not significantly correlate with hypnotic suggestibility (rs = 0.11 [-0.17 to 0.37]). In study 2, the placebo procedure did not yield a significant placebo response across the full sample (g = 0.11 [-0.11 to 0.33]), but the magnitude of individual placebo responsiveness significantly correlated with nonhypnotic suggestibility (rs = 0.27 [0.03 to 0.48]).
CONCLUSIONS


These results suggest that the extent to which direct verbal suggestibility captures variability in placebo responsiveness depends on the use of conditioning and highlights the utility of suggestibility as a potential contributing factor to placebo responding when placebo hypoalgesia is induced through verbal suggestions.",2021,"In Study 2, the placebo procedure did not yield a significant placebo response across the full sample (g = 0.11","['In Study 1 (N = 57; MAge = 23.7, SD = 8.1; 77% women), we used behavioural hypnotic suggestibility as a predictor of placebo hypoalgesia induced through conditioning and verbal suggestion whereas in Study 2 (N = 78; MAge = 26.1, SD = 7.4; 65% women), we measured non-hypnotic suggestibility and placebo hypoalgesia induced through verbal suggestion without conditioning']",[],"['moderate placebo response', 'magnitude of individual placebo responsiveness', 'hypnotic suggestibility']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0233423', 'cui_str': 'Suggestibility'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],"[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0233423', 'cui_str': 'Suggestibility'}]",,0.235556,"In Study 2, the placebo procedure did not yield a significant placebo response across the full sample (g = 0.11","[{'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Parsons', 'Affiliation': 'From the Department of Psychology, Goldsmiths (Parsons, Bergmann, Terhune), University of London, London, United Kingdom; Department of Psychology (Parsons), University of Bath, Bath, England; and Wellcome Centre for Integrative Neuroimaging & Nuffield Department of Clinical Neurosciences (Wiech), University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bergmann', 'Affiliation': ''}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wiech', 'Affiliation': ''}, {'ForeName': 'Devin B', 'Initials': 'DB', 'LastName': 'Terhune', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000977']
635,34294642,The Effect of Sodium Thiosulfate on Coronary Artery Calcification in Hemodialysis Patients.,"This study aimed to effectively control the disease process of hemodialysis outpatients. Hemodialysis secondary hyperparathyroidism patients were randomly divided into the control group and treatment group. The control group was treated with routine treatment, and the treatment group was treated with sodium thiosulfate based on the control group. The changes of serum calcium, phosphorus, whole parathyroid hormone, calcium-phosphorus product and coronary artery calcification (CAC) score, as well as the relief of clinical symptoms, postoperative complications and recurrence in the preoperative and postoperative periods were observed. The levels of C-reactive protein and CAC scores were significantly decreased in the treatment group after treatment. While there was no significant difference in blood calcium, blood phosphorus, PTH, calcium-phosphorus product, and CAC score in the control group after treatment. And after treatment, the proportion of skin pruritus, myasthenia, bone pain, insomnia, restless legs syndrome, and other symptoms in the treatment group was significantly decreased compared with those before treatment, but there was no significant change in the control group before and after treatment. Sodium thiosulfate can reduce the high level of CAC in hemodialysis patients obviously.",2022,"While there was no significant difference in blood calcium, blood phosphorus, PTH, calcium-phosphorus product, and CAC score in the control group after treatment.","['hemodialysis outpatients', 'Hemodialysis Patients', 'Hemodialysis secondary hyperparathyroidism patients']","['Sodium Thiosulfate', 'sodium thiosulfate based on the control group']","['levels of C-reactive protein and CAC scores', 'serum calcium, phosphorus, whole parathyroid hormone, calcium-phosphorus product and coronary artery calcification (CAC) score', 'blood calcium, blood phosphorus, PTH, calcium-phosphorus product, and CAC score', 'Coronary Artery Calcification', 'relief of clinical symptoms, postoperative complications and recurrence', 'proportion of skin pruritus, myasthenia, bone pain, insomnia, restless legs syndrome, and other symptoms']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020503', 'cui_str': 'Secondary hyperparathyroidism'}]","[{'cui': 'C0074774', 'cui_str': 'sodium thiosulfate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}, {'cui': 'C0729820', 'cui_str': 'Blood calcium measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0151825', 'cui_str': 'Bone pain'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}]",,0.0110958,"While there was no significant difference in blood calcium, blood phosphorus, PTH, calcium-phosphorus product, and CAC score in the control group after treatment.","[{'ForeName': 'Zhixiang', 'Initials': 'Z', 'LastName': 'Bian', 'Affiliation': ""From the Department of Nephrology, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Shanghai, China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Shunjie', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ''}]",ASAIO journal (American Society for Artificial Internal Organs : 1992),['10.1097/MAT.0000000000001531']
636,34293233,The effect of esketamine in patients with treatment-resistant depression with and without comorbid anxiety symptoms or disorder.,"BACKGROUND


Comorbid anxiety is generally associated with poorer response to antidepressant treatment. This post hoc analysis explored the efficacy of esketamine plus an antidepressant in patients with treatment-resistant depression (TRD) with or without comorbid anxiety.
METHODS


TRANSFORM-2, a double-blind, flexible-dose, 4-week study (NCT02418585), randomized adults with TRD to placebo or esketamine nasal spray, each with a newly-initiated oral antidepressant. Comorbid anxiety was defined as clinically noteworthy anxiety symptoms (7-item Generalized Anxiety Disorder scale [GAD-7] score ≥10) at screening and baseline or comorbid anxiety disorder diagnosis at screening. Treatment effect based on change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score, and response and remission were examined by presence/absence of comorbid anxiety using analysis of covariance and logistic regression models.
RESULTS


Approximately 72% (162/223) of patients had baseline comorbid anxiety. Esketamine-treated patients with and without anxiety demonstrated significant reductions in MADRS (mean [SD] change from baseline at day 28: -21.0 [12.51] and -22.7 [11.98], respectively). Higher rates of response and remission, and a significantly greater decrease in MADRS score at day 28 were observed compared to antidepressant/placebo, regardless of comorbid anxiety (with anxiety: difference in LS means [95% CI] -4.2 [-8.1, -0.3]; without anxiety: -7.5 [-13.7, -1.3]). There was no significant interaction of treatment and comorbid anxiety (p = .371). Notably, in the antidepressant/placebo group improvement was similar in those with and without comorbid anxiety.
CONCLUSION


Post hoc data support efficacy of esketamine plus an oral antidepressant in patients with TRD, regardless of comorbid anxiety.",2021,"Higher rates of response and remission, and a significantly greater decrease in MADRS score at day 28 were observed compared to antidepressant/placebo, regardless of comorbid anxiety (with anxiety: difference in LS means [95% CI]","['patients with treatment-resistant depression (TRD) with or without comorbid anxiety', 'patients with treatment-resistant depression with and without comorbid anxiety symptoms or disorder', 'patients with TRD, regardless of comorbid anxiety']","['esketamine', 'placebo', 'placebo or esketamine nasal spray, each with a newly-initiated oral antidepressant']","['comorbid anxiety', 'MADRS', 'baseline comorbid anxiety', 'Higher rates of response and remission', 'MADRS score', 'Montgomery-Åsberg Depression Rating Scale (MADRS) total score, and response and remission', 'Comorbid anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0756026,"Higher rates of response and remission, and a significantly greater decrease in MADRS score at day 28 were observed compared to antidepressant/placebo, regardless of comorbid anxiety (with anxiety: difference in LS means [95% CI]","[{'ForeName': 'Ella J', 'Initials': 'EJ', 'LastName': 'Daly', 'Affiliation': 'Department of Neuroscience Medical Affairs, Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Turkoz', 'Affiliation': 'Department of Statistics & Decision Sciences, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Salvadore', 'Affiliation': 'Department of Neuroscience, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Fedgchin', 'Affiliation': 'Department of Neuroscience, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Department of Neuroscience, Janssen Research & Development, LLC, San Diego, California, USA.'}, {'ForeName': 'H Lynn', 'Initials': 'HL', 'LastName': 'Starr', 'Affiliation': 'Department of Neuroscience Medical Affairs, Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Borentain', 'Affiliation': 'Department of Neuroscience Medical Affairs, Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania and the Corporal Michael J. Crescenz VAMC, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jaskaran B', 'Initials': 'JB', 'LastName': 'Singh', 'Affiliation': 'Department of Neuroscience, Janssen Research & Development, LLC, San Diego, California, USA.'}]",Depression and anxiety,['10.1002/da.23193']
637,34293223,Efficacy of temporally intensified exposure for anxiety disorders: A multicenter randomized clinical trial.,"BACKGROUND


The need to optimize exposure treatments for anxiety disorders may be addressed by temporally intensified exposure sessions. Effects on symptom reduction and public health benefits should be examined across different anxiety disorders with comorbid conditions.
METHODS


This multicenter randomized controlled trial compared two variants of prediction error-based exposure therapy (PeEx) in various anxiety disorders (both 12 sessions + 2 booster sessions, 100 min/session): temporally intensified exposure (PeEx-I) with exposure sessions condensed to 2 weeks (n = 358) and standard nonintensified exposure (PeEx-S) with weekly exposure sessions (n = 368). Primary outcomes were anxiety symptoms (pre, post, and 6-months follow-up). Secondary outcomes were global severity (across sessions), quality of life, disability days, and comorbid depression.
RESULTS


Both treatments resulted in substantial improvements at post (PeEx-I: d within   = 1.50, PeEx-S: d within   = 1.78) and follow-up (PeEx-I: d within   = 2.34; PeEx-S: d within   = 2.03). Both groups showed formally equivalent symptom reduction at post and follow-up. However, time until response during treatment was 32% shorter in PeEx-I (median = 68 days) than PeEx-S (108 days; TR PeEx-I   = 0.68). Interestingly, drop-out rates were lower during intensified exposure. PeEx-I was also superior in reducing disability days and improving quality of life at follow-up without increasing relapse.
CONCLUSIONS


Both treatment variants focusing on the transdiagnostic exposure-based violation of threat beliefs were effective in reducing symptom severity and disability in severe anxiety disorders. Temporally intensified exposure resulted in faster treatment response with substantial public health benefits and lower drop-out during the exposure phase, without higher relapse. Clinicians can expect better or at least comparable outcomes when delivering exposure in a temporally intensified manner.",2021,"PeEx-I was also superior in reducing disability days and improving quality of life at follow-up without increasing relapse.
",['anxiety disorders'],"['prediction error-based exposure therapy (PeEx', 'intensified exposure (PeEx-I) with exposure sessions condensed to 2 weeks (n\u2009=\u2009358) and standard nonintensified exposure (PeEx-S) with weekly exposure sessions']","['disability days and improving quality of life', 'time until response', 'global severity (across sessions), quality of life, disability days, and comorbid depression', 'anxiety symptoms (pre, post, and 6-months follow-up']","[{'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.0884528,"PeEx-I was also superior in reducing disability days and improving quality of life at follow-up without increasing relapse.
","[{'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Pittig', 'Affiliation': 'Department of Psychology (Biological Psychology Clinical Psychology, and Psychotherapy), Center of Mental Health, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Ingmar', 'Initials': 'I', 'LastName': 'Heinig', 'Affiliation': 'Institute of Clinical Psychology & Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Goerigk', 'Affiliation': 'Institute of Clinical Psychology & Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Freya', 'Initials': 'F', 'LastName': 'Thiel', 'Affiliation': 'Institute of Clinical Psychology & Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Hummel', 'Affiliation': 'Institute of Clinical Psychology & Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Scholl', 'Affiliation': 'Institute of Clinical Psychology & Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Deckert', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Pauli', 'Affiliation': 'Department of Psychology (Biological Psychology Clinical Psychology, and Psychotherapy), Center of Mental Health, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Domschke', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fydrich', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Fehm', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Plag', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind Brain and Behavior - CMBB, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind Brain and Behavior - CMBB, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Faculty of Psychology & Center for Mind, Brain and Behavior - CMBB, Philipps-University of Marburg, Marburg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Koelkebeck', 'Affiliation': 'Institute for Translational Psychiatry, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Institute for Translational Psychiatry, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Dannlowski', 'Affiliation': 'Institute for Translational Psychiatry, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Margraf', 'Affiliation': 'Mental Health Research and Treatment Center, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Totzeck', 'Affiliation': 'Mental Health Research and Treatment Center, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Mental Health Research and Treatment Center, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Neudeck', 'Affiliation': 'Institute of Clinical Psychology & Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Department of Psychology and Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, USA.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Hollandt', 'Affiliation': 'Department of Psychology, Biological and Clinical Psychology, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Richter', 'Affiliation': 'Department of Psychology, Biological and Clinical Psychology, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Alfons', 'Initials': 'A', 'LastName': 'Hamm', 'Affiliation': 'Department of Psychology, Biological and Clinical Psychology, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology & Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}]",Depression and anxiety,['10.1002/da.23204']
638,34293124,Oils Rich in α-Linolenic Acid or Docosahexaenoic Acid Have Distinct Effects on Plasma Oxylipin and Adiponectin Concentrations and on Monocyte Bioenergetics in Women with Obesity.,"BACKGROUND


Omega-3 fatty acids, including DHA and α-linolenic acid (ALA), are proposed to improve metabolic health by reducing obesity-associated inflammation. Their effects are mediated in part by conversion to oxylipins. ALA is relatively understudied, and direct comparisons to other omega-3 fatty acids are limited.
OBJECTIVES


We compared the effects of equal doses of ALA and DHA on plasma oxylipins and markers of metabolic health in women with obesity.
METHODS


We carried out a randomized, double-blind, crossover clinical trial where women aged 20-51 with a BMI of 30-51 kg/m2 were supplemented with 4 g/day of ALA or DHA for 4 weeks in the form of ALA-rich flaxseed oil or DHA-rich fish oil. The primary outcome, the plasma oxylipin profile, was assessed at Days 0 and 28 of each phase by HPLC-MS/MS. Plasma fatty acids, inflammatory markers, and the monocyte glucose metabolism were key secondary outcomes. Data were analyzed using a mixed model.
RESULTS


Compared to the baseline visit, there were higher plasma levels of nearly all oxylipins derived from DHA (3.8-fold overall; P < 0.001) and EPA (2.7-fold overall; P < 0.05) after 28 days of fish-oil supplementation, while there were no changes to oxylipins after flaxseed-oil supplementation. Neither supplement altered plasma cytokines; however, adiponectin was increased (1.1-fold; P < 0.05) at the end of the fish-oil phase. Compared to the baseline visit, 28 days of flaxseed-oil supplementation reduced ATP-linked oxygen consumption (0.75-fold; P < 0.05) and increased spare respiratory capacity (1.4-fold; P < 0.05) in monocytes, and countered the shift in oxygen consumption induced by LPS.
CONCLUSIONS


Flaxseed oil and fish oil each had unique effects on metabolic parameters in women with obesity. The supplementation regimens were insufficient to reduce inflammatory markers but adequate to elicit increases in omega-3 oxylipins and adiponectin in response to fish oil and to alter monocyte bioenergetics in response to flaxseed oil. This trial was registered at clinicaltrials.gov as NCT03583281.",2021,"Neither supplement altered plasma cytokines; however, adiponectin was increased (1.1-fold; P < 0.05) at the end of the fish-oil phase.","['women with obesity', 'women aged 20-51 with a BMI of 30-51 kg/m2 were supplemented with', 'Women with Obesity']","['ALA and DHA', 'Flaxseed oil and fish oil each', 'Docosahexaenoic Acid', 'ALA-rich flaxseed oil or DHA-rich fish oil', 'Omega-3 fatty acids, including DHA and α-linolenic acid (ALA', '4\xa0g/day of ALA or DHA']","['metabolic parameters', 'plasma cytokines', 'Plasma Oxylipin and Adiponectin Concentrations', 'spare respiratory capacity', 'Plasma fatty acids, inflammatory markers, and the monocyte glucose metabolism', 'plasma oxylipin profile', 'plasma levels', 'EPA', 'adiponectin', 'plasma oxylipins and markers of metabolic health', 'ATP-linked oxygen consumption']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0023754', 'cui_str': 'Linseed Oil'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",,0.739475,"Neither supplement altered plasma cytokines; however, adiponectin was increased (1.1-fold; P < 0.05) at the end of the fish-oil phase.","[{'ForeName': 'Samantha D', 'Initials': 'SD', 'LastName': 'Pauls', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Manitoba, Canada.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Rodway', 'Affiliation': 'Canadian Centre for Agri-Food Research in Health and Medicine, Winnipeg, Canada.'}, {'ForeName': 'Karanbir K', 'Initials': 'KK', 'LastName': 'Sidhu', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Manitoba, Canada.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Winter', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Manitoba, Canada.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Sidhu', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Manitoba, Canada.'}, {'ForeName': 'Harold M', 'Initials': 'HM', 'LastName': 'Aukema', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Manitoba, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zahradka', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Manitoba, Canada.'}, {'ForeName': 'Carla G', 'Initials': 'CG', 'LastName': 'Taylor', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Manitoba, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxab235']
639,34302228,Intervention mediating effects of self-efficacy on patient physical and psychological health following ICD implantation.,"This study examined mechanisms by which social cognitive theory (SCT) interventions influence health outcomes and the importance of involving partners in recovery following the patients' receipt of an initial implantable cardioverter defibrillator (ICD). We compared direct and indirect intervention effects on patient health outcomes with data from a randomized clinical trial involving two telephone-based interventions delivered during the first 3 months post-ICD implant by experienced trained nurses: P-only conducted only with patients, and P + P conducted with patients and their intimate partners. Each intervention included the patient-focused component. P + P also included a partner-focused intervention component. ICD-specific SCT-derived mediators included self-efficacy expectations, outcome expectations, self-management behavior, and ICD knowledge. Outcomes were assessed at discharge, 3- and 12-months post ICD implant. Patients (N = 301) were primarily Caucasian, male, 64 (± 11.9) years of age with a mean ejection fraction of 34.08 (± 14.3). Intervention effects, mediated through ICD-specific self-efficacy and outcome expectations, were stronger for P + P compared to P-only for physical function (β = 0.04, p = 0.04; β = 0.02, p = 0.04, respectively) and for psychological adjustment (β = 0.06, p = 0.04; β = 0.03, p = 0.04, respectively). SCT interventions show promise for improving ICD patient physical and psychological health outcomes through self-efficacy and outcome expectations. Including partners in post-ICD interventions may potentiate positive outcomes for patients.Trial registration number (TRN): NCT01252615 (Registration date: 12/02/2010).",2021,"Intervention effects, mediated through ICD-specific self-efficacy and outcome expectations, were stronger for P + P compared to P-only for physical function (β = 0.04, p = 0.04; β = 0.02, p = 0.04, respectively) and for psychological adjustment (β = 0.06, p = 0.04; β = 0.03, p = 0.04, respectively).","['by experienced trained nurses: P-only conducted only with patients, and P\u2009+\u2009P conducted with patients and their intimate partners', 'patient physical and psychological health following ICD implantation', 'Patients (N\u2009=\u2009301) were primarily Caucasian, male, 64 (±\u200911.9) years of age with a mean ejection fraction of 34.08 (±\u200914.3']","['telephone-based interventions delivered during the first 3\xa0months post-ICD implant', 'SCT interventions', 'initial implantable cardioverter defibrillator (ICD', 'social cognitive theory (SCT) interventions']","['ICD patient physical and psychological health outcomes', 'ICD-specific self-efficacy and outcome expectations']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",301.0,0.0341791,"Intervention effects, mediated through ICD-specific self-efficacy and outcome expectations, were stronger for P + P compared to P-only for physical function (β = 0.04, p = 0.04; β = 0.02, p = 0.04, respectively) and for psychological adjustment (β = 0.06, p = 0.04; β = 0.03, p = 0.04, respectively).","[{'ForeName': 'Ana C S', 'Initials': 'ACS', 'LastName': 'Liberato', 'Affiliation': 'Evidera PPD Inc., Patient Centered Research, London, UK.'}, {'ForeName': 'Elaine A', 'Initials': 'EA', 'LastName': 'Thompson', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, University of Washington School of Nursing, 1959 NE Pacific Street, 357266, Seattle, WA, 98195, USA.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Dougherty', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, University of Washington School of Nursing, 1959 NE Pacific Street, 357266, Seattle, WA, 98195, USA. cindyd@uw.edu.'}]",Journal of behavioral medicine,['10.1007/s10865-021-00244-8']
640,34311606,"The dosing procedure that ""makes the poison"": Comparing the effects of single versus cumulative alcohol administration methods on emotion recognition.","BACKGROUND


Most people often consume alcohol cumulatively and gradually. Yet almost scientific knowledge about alcohol's acute effects on cognition, behavior, and affect stems from laboratory studies that employ a single beverage administration procedure.
OBJECTIVE


This study tests the hypothesis that alcohol's acute effects depend on both methods of administration and alcohol blood level. We introduce a new laboratory procedure for studying cumulative alcohol drinking and examine alcohol's effects on emotion recognition as a function of both alcohol administration method and alcohol blood level.
METHODS


Participants were recruited for one of two studies. One study employed a between-subject design using a single alcoholic dose. Participants were randomly assigned to drink either placebo (0.00%), low (0.03%), moderate (0.06%), or high (0.09%) alcohol levels. The second study employed a within-subject design using a cumulative alcoholic administration method, in which each participant drank four drinks (placebo, followed by three alcoholic drinks). Both groups reached similar breath alcohol concentrations. In both studies, participants attended a single study session, in which emotion recognition was examined following alcohol administration.
RESULTS


Single alcoholic beverage administration method caused greater impairment in emotion recognition ability, specifically for anger, happiness, and fear, as compared with cumulative administration method, even though breath alcohol levels were similar in both conditions.
CONCLUSIONS


This paper presents questions concerning the internal validity of previous laboratory studies that use a single beverage administration procedure. Insights into the effects of alcohol on behavior, as well as regarding our knowledge about models of addiction are presented.",2021,"RESULTS


Single alcoholic beverage administration method caused greater impairment in emotion recognition ability, specifically for anger, happiness, and fear, as compared with cumulative administration method, even though breath alcohol levels were similar in both conditions.
",['Participants were recruited for one of two studies'],"['placebo', 'participant drank four drinks (placebo']","['emotion recognition', 'breath alcohol levels', 'impairment in emotion recognition ability, specifically for anger, happiness, and fear', 'breath alcohol concentrations']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0202306', 'cui_str': 'Ethanol measurement, breath'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0249341,"RESULTS


Single alcoholic beverage administration method caused greater impairment in emotion recognition ability, specifically for anger, happiness, and fear, as compared with cumulative administration method, even though breath alcohol levels were similar in both conditions.
","[{'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Nagar', 'Affiliation': 'School of Criminology, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Weller', 'Affiliation': 'Psychology Department and Gonda Brain Research Center, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Rabinovitz', 'Affiliation': 'School of Criminology and The Unit for Excellence in Research and Study of Addiction, The Center for Rehabilitation Research, University of Haifa, Haifa, Israel.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/02698811211032466']
641,34309859,Prevention of infant eczema by neonatal Bacillus Calmette-Guérin vaccination: The MIS BAIR randomized controlled trial.,"BACKGROUND


Bacille Calmette-Guérin (BCG) vaccine could play a role in counteracting the rising prevalence of atopic diseases, through its beneficial off-target effects. We aimed to determine whether neonatal BCG vaccination reduces the incidence of eczema in infants.
METHODS


Randomized controlled trial with 1272 infants allocated to receive BCG-Denmark or no BCG at birth. The primary outcome was the 12-month incidence of eczema based on 3-monthly questionnaires. Eczema was also assessed at a 12-month clinic visit. ClinicalTrial.gov: NCT01906853.
RESULTS


The 12-month eczema incidence was 32.2% in the BCG group compared with 36.6% in the control group (adjusted risk difference (aRD) -4.3%, 95% CI -9.9% to 1.3%, multiple imputation model). In addition, comparing infants in the BCG group with the control group, 15.7% vs. 19.2% had eczema lesions at the 12-month visit (aRD -3.5%, 95% CI -8.0% to 1.0%); 35.7% vs. 39.0% reported using topical steroids (aRD -3.3, 95% CI -9.2 to 2.7); and 7.3% vs. 10.2% had severe eczema scores (aRD -3.0%, 95% CI -8.8% to 2.7%). In 344 high-risk infants (two atopic parents), the 12-month eczema incidence was 35.3% in the BCG group compared with 46.8% in the control group (aRD -11.5%, 95% CI -21.9% to -1.2%; number needed to treat 8.7, 95% CI 4.6 to 83.3).
CONCLUSION


There is insufficient evidence to recommend neonatal BCG vaccination in all infants for the prevention of eczema in the first year of life; however, a modest beneficial effect was observed among high-risk infants. A single dose of BCG-Denmark soon after birth could reduce the incidence of eczema in infants with two atopic parents.",2022,"There is insufficient evidence to recommend neonatal BCG vaccination in all infants for the prevention of eczema in the first year of life; however, a modest beneficial effect was observed among high-risk infants.","['1272 infants allocated to receive BCG-Denmark or no BCG at birth', 'infants with two atopic parents', 'infants', '344 high-risk infants (two atopic parents']","['neonatal Bacillus Calmette-Guérin vaccination', 'Bacille Calmette-Guérin (BCG) vaccine', 'neonatal BCG vaccination']","['12-month incidence of eczema based on 3-monthly questionnaires', 'severe eczema scores', 'incidence of eczema', 'eczema lesions', 'Eczema', '12-month eczema incidence']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0392707', 'cui_str': 'Atopy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0419437', 'cui_str': 'High risk infant'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",2.0,0.436971,"There is insufficient evidence to recommend neonatal BCG vaccination in all infants for the prevention of eczema in the first year of life; however, a modest beneficial effect was observed among high-risk infants.","[{'ForeName': 'Laure F', 'Initials': 'LF', 'LastName': 'Pittet', 'Affiliation': ""Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Messina', 'Affiliation': ""Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Kaya', 'Initials': 'K', 'LastName': 'Gardiner', 'Affiliation': ""Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Freyne', 'Affiliation': ""Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Abruzzo', 'Affiliation': ""Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Francis', 'Affiliation': ""Clinical Epidemiology & Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Morrison', 'Affiliation': ""Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Zufferey', 'Affiliation': ""Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vuillermin', 'Affiliation': 'School of Medicine, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Allen', 'Affiliation': ""Formerly Centre for Food and Allergy Research, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Anne-Louise', 'Initials': 'AL', 'LastName': 'Ponsonby', 'Affiliation': ""Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Robins-Browne', 'Affiliation': ""Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Shann', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Flanagan', 'Affiliation': 'School of Health Sciences, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Rod', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Donath', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Casalaz', 'Affiliation': 'Neonatal Intensive Care Unit, Mercy Hospital for Women, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Curtis', 'Affiliation': ""Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}]",Allergy,['10.1111/all.15022']
642,34303602,"Implementation Science Strategies Promote Fidelity in the Food, Feeding, and Your Family Study.","OBJECTIVE


Use of implementation science strategies to promote fidelity in the Food, Feeding, and Your Family study.
DESIGN


Cluster randomized controlled trial with 3 conditions: control, in-class, or online, delivered in English or Spanish. Observations of 20% of classes.
SETTING


Expanded Food and Nutrition Education Program (EFNEP) in 2 states.
PARTICIPANTS


EFNEP peer educators (n = 11).
INTERVENTION


Parental feeding content incorporated into EFNEP lessons (in-class) or through text with links to videos/activities (online). Extensive educator training, scripted curriculum, frequent feedback.
ANALYSIS


Assessment of fidelity compliance. Qualitative analysis of verbatim educator interviews and classroom observer comments.
RESULTS


During 128 class observations (40-45 per condition), peer educators followed scripted lesson plan 78% to 89% of the time. There was no evidence of cross-contamination of parental feeding content in control and only minor sharing in online conditions. Variations with fidelity were primarily tied to the EFNEP curriculum, not the parent feeding content. Educators (n = 7) expressed favorable opinions about the Food, Feeding, and Your Family study, thought it provided valuable information, and appreciated support from EFNEP leadership.
CONCLUSIONS AND IMPLICATIONS


Incorporating implementation science strategies can help ensure successful adherence to research protocols. With proper training and support, EFNEP peer educators can deliver an evidence-based curriculum as part of a complex research study.",2021,There was no evidence of cross-contamination of parental feeding content in control and only minor sharing in online conditions.,['EFNEP peer educators (n\u202f=\u202f11'],"['Nutrition Education Program', 'Parental feeding content incorporated into EFNEP lessons (in-class) or through text with links to videos/activities (online']",['fidelity compliance'],"[{'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.0256781,There was no evidence of cross-contamination of parental feeding content in control and only minor sharing in online conditions.,"[{'ForeName': 'M Catalina', 'Initials': 'MC', 'LastName': 'Aragón', 'Affiliation': 'Washington State University Extension, Pierce County, Tacoma, WA. Electronic address: c.aragon@wsu.edu.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Auld', 'Affiliation': 'Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Baker', 'Affiliation': 'Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO.'}, {'ForeName': 'Karen V', 'Initials': 'KV', 'LastName': 'Barale', 'Affiliation': 'Washington State University Extension, Pierce County, Tacoma, WA.'}, {'ForeName': 'Karina Silva', 'Initials': 'KS', 'LastName': 'Garcia', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA.'}, {'ForeName': 'Nilda', 'Initials': 'N', 'LastName': 'Micheli', 'Affiliation': ""US Department of Agriculture, Agricultural Research Service, Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Parker', 'Affiliation': 'Washington State University Extension, Seattle, WA.'}, {'ForeName': 'Jane D', 'Initials': 'JD', 'LastName': 'Lanigan', 'Affiliation': 'Department of Human Development, Washington State University, Vancouver, WA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Power', 'Affiliation': 'Department of Human Development, Washington State University, Pullman, WA.'}, {'ForeName': 'Sheryl O', 'Initials': 'SO', 'LastName': 'Hughes', 'Affiliation': ""US Department of Agriculture, Agricultural Research Service, Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX.""}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2021.06.001']
643,34305196,BRIEF MOTIVATIONAL INTERVENTION FOR SUBSTANCE USE MAY DECREASE VIOLENCE AMONG HEAVY ALCOHOL USERS IN A JAIL DIVERSION PROGRAM.,"Rates of harmful alcohol use are high among justice-involved individuals and may contribute to violent recidivism. Robust treatments for alcohol-related violence in criminal justice systems are thus a public health priority. In this analysis of existing randomized controlled trial data ( N  = 105), we examined the impact of a brief motivational intervention (BMI) for harmful substance use on violent recidivism among individuals in a pretrial jail diversion program. Results indicated that, after controlling for violence history, the intervention's impact on violent recidivism was moderated by baseline harmful alcohol use. Specifically, among people with severe alcohol problems at baseline, the BMI + standard care group had less violent recidivism at a 1-year follow-up than participants randomized to standard care alone. This finding was unchanged when we accounted for psychopathic traits. Our study provides preliminary evidence that a BMI may be useful for decreasing violent recidivism among heavy drinkers in criminal justice systems.",2021,"Results indicated that, after controlling for violence history, the intervention's impact on violent recidivism was moderated by baseline harmful alcohol use.",['individuals in a pretrial jail diversion program'],['brief motivational intervention (BMI'],['violent recidivism'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0185033', 'cui_str': 'Diversion procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}]",,0.0343816,"Results indicated that, after controlling for violence history, the intervention's impact on violent recidivism was moderated by baseline harmful alcohol use.","[{'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Catterall', 'Affiliation': 'Leeds Beckett University.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Mitchell', 'Affiliation': 'University of Rochester Medical Center.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Dhingra', 'Affiliation': 'Leeds Beckett University.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Conner', 'Affiliation': 'University of Rochester Medical Center.'}, {'ForeName': 'Marc T', 'Initials': 'MT', 'LastName': 'Swogger', 'Affiliation': 'University of Rochester Medical Center.'}]",Criminal justice and behavior,['10.1177/0093854820958747']
644,34309124,Effects of participation in a U.S. trial of newborn genomic sequencing on parents at risk for depression.,"Much emphasis has been placed on participant's psychological safety within genomic research studies; however, few studies have addressed parental psychological health effects associated with their child's participation in genomic studies, particularly when parents meet the threshold for clinical concern for depression. We aimed to determine if parents' depressive symptoms were associated with their child's participation in a randomized-controlled trial of newborn exome sequencing. Parents completed the Edinburgh Postnatal Depression Scale (EPDS) at baseline, immediately post-disclosure, and 3 months post-disclosure. Mothers and fathers scoring at or above thresholds for clinical concern on the EPDS, 12 and 10, respectively, indicating possible Major Depressive Disorder with Peripartum Onset, were contacted by study staff for mental health screening. Parental concerns identified in follow-up conversations were coded for themes. Forty-five parents had EPDS scores above the clinical threshold at baseline, which decreased by an average of 2.9 points immediately post-disclosure and another 1.1 points 3 months post-disclosure (both p ≤ .014). For 28 parents, EPDS scores were below the threshold for clinical concern at baseline, increased by an average of 4.7 points into the elevated range immediately post-disclosure, and decreased by 3.8 points at 3 months post-disclosure (both p < .001). Nine parents scored above thresholds only at 3 months post-disclosure after increasing an average of 5.7 points from immediately post-disclosure (p < .001). Of the 82 parents who scored above the threshold at any time point, 43 (52.4%) were reached and 30 (69.7%) of these 43 parents attributed their elevated scores to parenting stress, balancing work and family responsibilities, and/or child health concerns. Only three parents (7.0%) raised concerns about their participation in the trial, particularly their randomization to the control arm. Elevated scores on the EPDS were typically transient and parents attributed their symptomatology to life stressors in the postpartum period rather than participation in a trial of newborn exome sequencing.",2022,"For 28 parents, EPDS scores were below the threshold for clinical concern at baseline, increased by an average of 4.7 points into the elevated range immediately post-disclosure, and decreased by 3.8 points at 3 months post-disclosure (both p < .001).","[""parents' depressive symptoms"", 'parents at risk for depression']",['newborn genomic sequencing'],"['Edinburgh Postnatal Depression Scale (EPDS', 'parenting stress, balancing work and family responsibilities, and/or child health concerns', 'EPDS scores']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",82.0,0.0662857,"For 28 parents, EPDS scores were below the threshold for clinical concern at baseline, increased by an average of 4.7 points into the elevated range immediately post-disclosure, and decreased by 3.8 points at 3 months post-disclosure (both p < .001).","[{'ForeName': 'Talia S', 'Initials': 'TS', 'LastName': 'Schwartz', 'Affiliation': ""Division of Genetics and Genomics, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Kurt D', 'Initials': 'KD', 'LastName': 'Christensen', 'Affiliation': 'PRecisiOn Medicine Translational Research (PROMoTeR) Center, Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Melissa K', 'Initials': 'MK', 'LastName': 'Uveges', 'Affiliation': ""Division of Genetics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Waisbren', 'Affiliation': ""Division of Genetics and Genomics, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'McGuire', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Pereira', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Jill O', 'Initials': 'JO', 'LastName': 'Robinson', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Beggs', 'Affiliation': ""Division of Genetics and Genomics, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Green', 'Affiliation': 'The Broad Institute of MIT and Harvard, Cambridge, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Gloria A', 'Initials': 'GA', 'LastName': 'Bachmann', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Piscataway, New Jersey, USA.'}, {'ForeName': 'Arnold B', 'Initials': 'AB', 'LastName': 'Rabson', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Piscataway, New Jersey, USA.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Holm', 'Affiliation': ""Division of Genetics and Genomics, Boston Children's Hospital, Boston, Massachusetts, USA.""}]",Journal of genetic counseling,['10.1002/jgc4.1475']
645,34304951,Evaluation of dual-energy CT derived radiomics signatures in predicting outcomes in patients with advanced gastric cancer after neoadjuvant chemotherapy.,"BACKGROUND


To investigate the prognostic value of dual-energy CT (DECT) based radiomics to predict disease-free survival (DFS) and overall survival (OS) for patients with advanced gastric cancer (AGC) after neoadjuvant chemotherapy (NAC).
METHODS


From January 2014 to December 2018, a total of 156 AGC patients were enrolled and randomly allocated into a training cohort and a testing cohort at a ratio of 2:1. Volume of interest of primary tumor was delineated on eight image series. Four feature sets derived from pre-NAC and delta radiomics were generated for each survival arm. Random survival forest was used for generating the optimal radiomics signature (RS). Statistical metrics for model evaluation included Harrell's concordance index (C-index) and the average cumulative/dynamic AUC throughout follow-up. A clinical model and a combined Rad-clinical model were built for comparison.
RESULTS


The pre-IU (derived from iodine uptake images before NAC) RS performed best for DFS and OS in the testing cohort (C-indices, 0.784 and 0.698; the average cumulative/dynamic AUCs, 0.80 and 0.77). When compared with the clinical model, the radiomics model had significantly higher C-index to predict DFS in the testing cohort (0.784 vs. 0.635, p < 0.001), but no statistical difference was found for OS (0.698 vs. 0.680, p = 0.473). The combined Rad-clinical models showed improved performance in the testing cohort, with C-indices of 0.810 and 0.710 for DFS and OS, respectively.
CONCLUSION


DECT-derived radiomics serves as a promising non-invasive biomarker to predict survival for AGC patients after NAC, providing an opportunity for transforming proper treatment.",2022,"The combined Rad-clinical models showed improved performance in the testing cohort, with C-indices of 0.810 and 0.710 for DFS and OS, respectively.
","['patients with advanced gastric cancer (AGC) after neoadjuvant chemotherapy (NAC', 'From January 2014 to December 2018, a total of 156 AGC patients', 'patients with advanced gastric cancer after neoadjuvant chemotherapy']","['dual-energy CT (DECT', 'dual-energy CT derived radiomics signatures']","['disease-free survival (DFS) and overall survival (OS', ""Harrell's concordance index (C-index) and the average cumulative/dynamic AUC""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",156.0,0.061174,"The combined Rad-clinical models showed improved performance in the testing cohort, with C-indices of 0.810 and 0.710 for DFS and OS, respectively.
","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No 197, Rui Jin 2nd Road, Shanghai, 200025, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': 'Department of Pathology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No 197, Rui Jin 2nd Road, Shanghai, 200025, China.'}, {'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No 197, Rui Jin 2nd Road, Shanghai, 200025, China.'}, {'ForeName': 'Elsie', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': 'Shanghai Engineering Research Center for Broadband Technologies & Applications, No 150, Honggu Road, Shanghai, 200336, China.'}, {'ForeName': 'Zhihan', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Siemens Healthineers Ltd, No. 278, Zhouzhu Road, Shanghai, 201318, China.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wels', 'Affiliation': 'Department of Diagnostic Imaging Computed Tomography Image Analytics, Siemens Healthcare GmbH, Siemensstr, 391301, Forchheim, Germany.'}, {'ForeName': 'Weiwu', 'Initials': 'W', 'LastName': 'Yao', 'Affiliation': 'Department of Radiology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, No. 738, Yuyuan Road, Shanghai, 200050, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No 197, Rui Jin 2nd Road, Shanghai, 200025, China. Electronic address: Zh10765@rjh.com.cn.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2021.07.014']
646,34313619,Effect of Iron Supplementation in Children with Attention-Deficit/Hyperactivity Disorder and Iron Deficiency: A Randomized Controlled Trial.,"OBJECTIVES


To determine the effectiveness of combined iron supplementation and methylphenidate treatment on attention-deficit/hyperactivity disorder (ADHD) symptoms in children/adolescents with ADHD and iron deficiency compared with methylphenidate alone.
METHODS


In total, 116 children/adolescents with ADHD were screened for iron deficiency. Participants who exhibited iron deficiency were randomized into 2 groups (ferrous supplementation vs placebo). Vanderbilt ADHD rating scales were completed by parents and teachers at prestudy and poststudy periods. Student's t tests were used to determine improvements of Vanderbilt scores between the groups.
RESULTS


Among 116 children who participated in this study, 44.8% (52/116) met the criteria for iron deficiency. Of the total 52 participants with iron deficiency, 26 were randomized to the ferrous group and 26 to the placebo group. Most participants in each group had been prescribed short-acting methylphenidate twice daily in the morning and at noon. After a 12-week study period, total parents' Vanderbilt ADHD symptom scores showed a significant improvement between the groups (mean decrement = -3.96 ± 6.79 vs 0 ± 6.54, p = 0.037). However, teachers' Vanderbilt ADHD symptom scores showed no difference between the groups.
CONCLUSION


Children with ADHD and iron deficiency being on methylphenidate and iron supplementation had shown improvement of ADHD symptoms that were reported by parents.",2022,"However, teachers' Vanderbilt ADHD symptom scores showed no difference between the groups.
","['Participants who exhibited iron deficiency', 'Children with Attention-Deficit/Hyperactivity Disorder and Iron Deficiency', 'Of the total 52 participants with iron deficiency, 26 were randomized to the ferrous group and 26 to the', 'Children with ADHD and iron deficiency being on', '116 children who participated in this study, 44.8% (52/116) met the criteria for iron deficiency', 'children/adolescents with ADHD and iron deficiency compared with methylphenidate alone', '116 children/adolescents with ADHD were screened for iron deficiency']","['combined iron supplementation and methylphenidate treatment', 'placebo', 'methylphenidate and iron supplementation', 'methylphenidate', 'Iron Supplementation', 'ferrous supplementation vs placebo']","['Vanderbilt scores', 'Vanderbilt ADHD rating scales', 'attention-deficit/hyperactivity disorder (ADHD) symptoms', ""total parents' Vanderbilt ADHD symptom scores"", ""teachers' Vanderbilt ADHD symptom scores"", 'ADHD symptoms']","[{'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",116.0,0.216872,"However, teachers' Vanderbilt ADHD symptom scores showed no difference between the groups.
","[{'ForeName': 'Atcha', 'Initials': 'A', 'LastName': 'Pongpitakdamrong', 'Affiliation': 'Division of Developmental and Behavioral Pediatrics, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Vilawan', 'Initials': 'V', 'LastName': 'Chirdkiatgumchai', 'Affiliation': 'Division of Developmental and Behavioral Pediatrics, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nichara', 'Initials': 'N', 'LastName': 'Ruangdaraganon', 'Affiliation': 'Division of Developmental and Behavioral Pediatrics, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rawiwan', 'Initials': 'R', 'LastName': 'Roongpraiwan', 'Affiliation': 'Division of Developmental and Behavioral Pediatrics, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nongnuch', 'Initials': 'N', 'LastName': 'Sirachainan', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Manas', 'Initials': 'M', 'LastName': 'Soongprasit', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Umaporn', 'Initials': 'U', 'LastName': 'Udomsubpayakul', 'Affiliation': 'Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000993']
647,34311441,Effects of High-Intensity Interval Training on the Vascular and Autonomic Components of the Baroreflex at Rest in Adolescents.,"PURPOSE


In a sample of healthy adolescents, the authors aimed to investigate the effects of high-intensity interval exercise (HIIE) training and detraining on baroreflex sensitivity (BRS) and it's vascular and autonomic components at rest.
METHODS


Nineteen volunteers were randomly allocated to (1) 4 weeks HIIE training performed 3 times per week or (2) a control condition with no intervention for the same duration as HIIE training. PRE, POST, and following 2 weeks of detraining resting supine heart rate and blood pressure were measured, and a cross-spectral method (integrated gain [gain in low frequency]) was used to determine BRS gain. Arterial compliance (AC) was assessed as the BRS vascular component. LFgain divided by AC (LFgain/AC) was used as the autonomic determinant of BRS.
RESULTS


The HIIE training was completed with 100% compliance. HIIE did not change resting gain in low frequency (LFgain) (P = .66; effect size = 0.21), AC (P = .44; effect size = 0.36), or LFgain/AC (P = .68; effect size = 0.19) compared to control.
CONCLUSION


Four weeks of HIIE training does not change BRS and its autonomic and vascular determinant in a sample of healthy adolescents at rest.",2021,Four weeks of HIIE training does not change BRS and its autonomic and vascular determinant in a sample of healthy adolescents at rest.,"['healthy adolescents', 'Nineteen volunteers', 'Adolescents']","['HIIE training', 'High-Intensity Interval Training', 'high-intensity interval exercise (HIIE) training and detraining', 'LFgain divided by AC (LFgain/AC', 'HIIE training performed 3 times per week or (2)\xa0a control condition with no intervention for the same duration as HIIE training']","['Arterial compliance (AC', 'low frequency (LFgain', 'baroreflex sensitivity (BRS']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",19.0,0.0110634,Four weeks of HIIE training does not change BRS and its autonomic and vascular determinant in a sample of healthy adolescents at rest.,"[{'ForeName': 'Ricardo S', 'Initials': 'RS', 'LastName': 'Oliveira', 'Affiliation': 'University of Exeter.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Barker', 'Affiliation': 'University of Exeter.'}, {'ForeName': 'Sascha H', 'Initials': 'SH', 'LastName': 'Kranen', 'Affiliation': 'University of Exeter.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Debras', 'Affiliation': 'University of Exeter.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Williams', 'Affiliation': 'University of Exeter.'}]",Pediatric exercise science,['10.1123/pes.2020-0220']
648,34314843,Examining the influence of mental stress on balance perturbation responses in older adults.,"BACKGROUND


Reach-to-grasp responses following balance perturbations are important to fall prevention but are often ineffective in older adults. The ability to shift attention from an ongoing cognitive task to balance related processes has been shown to influence reach-to-grasp effectiveness in older adults. However, the added influence of stress and anxiety - known to negatively affect attention shifting ability - has not yet been explored in relation to recovery from balance perturbations. Given that fear and anxiety over falling is a key fall risk factor, an understanding of how such a negative mental state may affect postural reactions is important. This study aimed to investigate the effect of varied induced emotional states on reach-to-grasp balance responses in older adults.
METHODS


Healthy older adults (mean age 70.5 ± 5.38 years) stood laterally between 2 handrails with contact sensors. A safety harness with an integrated loadcell was worn to prevent falls and measure the amount of harness assistance (expressed as percent body weight). With instructions to grasp one rail to restore balance, participants' balance was laterally disturbed using surface translations under three randomized conditions: no cognitive task, neutral (verb generation) task, and mental stress task with negative prompts (paced auditory serial addition). The primary outcome was frequency of protective grasps. Secondary outcomes included frequency of harness assistance during trials with grasp errors as well as wrist movement time, trajectory distance, and peak velocity.
RESULTS


Perceived level of distress was highest for the mental stress task compared to no task (p < 0.001) and neutral task conditions (p = 0.008). The mental stress task resulted in the lowest percentage of protective grasps (p < 0.001) in response to balance perturbations. Closer examination of trials that resulted in grasp errors (i.e., collisions or overshoots), revealed increased harness assistance and reduced peak velocity of wrist movement (p < 0.001) under the mental stress condition compared to grasp errors that occurred under the no task or neutral task condition.
DISCUSSION AND CONCLUSION


Distressing mental thoughts immediately prior to a balance perturbation lead to reduced effectiveness in reach-to-grasp balance responses compared to no or neutral cognitive tasks and should be considered as a possible fall risk factor.",2021,"RESULTS


Perceived level of distress was highest for the mental stress task compared to no task (p < 0.001) and neutral task conditions (p = 0.008).","['Healthy older adults (mean age 70.5\xa0±', 'older adults']","['cognitive task, neutral (verb generation) task, and mental stress task with negative prompts (paced auditory serial addition']","['frequency of harness assistance during trials with grasp errors as well as wrist movement time, trajectory distance, and peak velocity', 'neutral task conditions', 'harness assistance and reduced peak velocity of wrist movement', 'level of distress', 'frequency of protective grasps']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3873748', 'cui_str': 'Harness'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.0240657,"RESULTS


Perceived level of distress was highest for the mental stress task compared to no task (p < 0.001) and neutral task conditions (p = 0.008).","[{'ForeName': 'Ruth Y', 'Initials': 'RY', 'LastName': 'Akinlosotu', 'Affiliation': 'University of Maryland School of Medicine, Department of Physical Therapy and Rehabilitation Science, Baltimore, MD 21201, USA. Electronic address: Ruakinlosotu@umaryland.edu.'}, {'ForeName': 'Nesreen', 'Initials': 'N', 'LastName': 'Alissa', 'Affiliation': 'University of Maryland School of Medicine, Department of Physical Therapy and Rehabilitation Science, Baltimore, MD 21201, USA. Electronic address: nesreen.alissa@som.umaryland.edu.'}, {'ForeName': 'Shari R', 'Initials': 'SR', 'LastName': 'Waldstein', 'Affiliation': 'Department of Psychology, University of Maryland Baltimore County, Baltimore, MD 21250, USA; Department of Medicine, University of Maryland School of Medicine, Baltimore, MD 21201, USA. Electronic address: waldstei@umbc.edu.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Creath', 'Affiliation': 'Department of Exercise Science, Lebanon Valley College, Annville, PA 17003, USA. Electronic address: creath@lvc.edu.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Wittenberg', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Human Engineering Research Laboratory, VA Pittsburgh Healthcare System, USA; Department of Neurology, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA. Electronic address: geowitt@pitt.edu.'}, {'ForeName': 'Kelly P', 'Initials': 'KP', 'LastName': 'Westlake', 'Affiliation': 'University of Maryland School of Medicine, Department of Physical Therapy and Rehabilitation Science, Baltimore, MD 21201, USA. Electronic address: kwestlake@som.umaryland.edu.'}]",Experimental gerontology,['10.1016/j.exger.2021.111495']
649,34318607,Sovesudil (locally acting rho kinase inhibitor) for the treatment of normal-tension glaucoma: the randomized phase II study.,"PURPOSE


To evaluate ocular hypotensive efficacy and the safety of sovesudil (formally known as PHP-201), a novel Rho-associated protein kinase (ROCK) inhibitor, in patients with normal-tension glaucoma (NTG).
DESIGN


Multicentre, prospective, double-masked, randomized, placebo-controlled, parallel clinical study.
METHODS


Patients with NTG (unmedicated baseline IOP ≤ 21 mmHg) were randomized in 3 groups and treated with sovesudil in concentrations of 0.25% and 0.5%, or with a placebo three times daily (TID) for 4 weeks. The primary end-point was the mean diurnal IOP change from the baseline at week 4. Safety was recorded over a 4-week treatment period and the following 2-week observation period.
RESULTS


A total of 119 patients were included in the primary efficacy analysis. The mean diurnal IOP change from the baseline at week 4 was -1.56 mmHg for the high-dose group, -1.10 mmHg for the low-dose group and -0.65 mmHg for the placebo group. The difference between the high-dose and the placebo groups was -0.91 mmHg (95% confidence intervals: -1.73, -0.09). 0.5% sovesudil TID met the criteria for superiority to the placebo. The most frequent ocular adverse event among sovesudil-treated patients was conjunctival hyperaemia (24.4% for the high-dose and 17.5% for the low-dose group) and predominately classified as mild.
CONCLUSIONS


Sovesudil 0.25% and 0.5% TID showed statistically significant IOP-lowering effects and 0.5% concentration's IOP-lowering effects met the superiority criteria in comparison with the placebo at week 4. Sovesudil was well tolerated with mild adverse events including relatively low incidence of conjunctival hyperaemia in patients with NTG.",2022,TID showed statistically significant IOP-lowering effects and 0.5% concentration's IOP-lowering effects met the superiority criteria in comparison with the placebo at week 4.,"['patients with normal-tension glaucoma (NTG', 'Patients with NTG (unmedicated baseline IOP', '119 patients', 'normal-tension glaucoma', 'patients with NTG']","['placebo', 'Sovesudil (locally acting rho kinase inhibitor']","['conjunctival hyperaemia', 'mean diurnal IOP change', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152136', 'cui_str': 'Low tension glaucoma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C4722003', 'cui_str': 'Rho-associated protein kinase inhibitor'}]","[{'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",119.0,0.345391,TID showed statistically significant IOP-lowering effects and 0.5% concentration's IOP-lowering effects met the superiority criteria in comparison with the placebo at week 4.,"[{'ForeName': 'Ahnul', 'Initials': 'A', 'LastName': 'Ha', 'Affiliation': 'Department of Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young Kook', 'Initials': 'YK', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Wook', 'Initials': 'JW', 'LastName': 'Jeoung', 'Affiliation': 'Department of Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Satyal', 'Affiliation': 'pH-Pharma Co., Ltd, Seoul, Korea.'}, {'ForeName': 'Jaesoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'pH-Pharma Co., Ltd, Seoul, Korea.'}, {'ForeName': 'Soojin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'pH-Pharma Co., Ltd, Seoul, Korea.'}, {'ForeName': 'Ki Ho', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, Seoul National University College of Medicine, Seoul, Korea.'}]",Acta ophthalmologica,['10.1111/aos.14949']
650,34346729,Sustainment of Integrated Care in Addiction Treatment Settings: Primary Outcomes From a Cluster-Randomized Controlled Trial.,"OBJECTIVE


Integrated treatment services are the gold standard for addressing co-occurring mental and substance use disorders, yet they are not readily available. The Network for the Improvement of Addiction Treatment (NIATx) was hypothesized to be an effective strategy to implement and sustain integrated mental health and substance use care in addiction treatment programs. This study examined sustainment of integrated services for up to 2 years after the active implementation phase.
METHODS


The effectiveness of NIATx strategies to implement and sustain integrated services was evaluated by using a cluster-randomized, waitlist control group design. Forty-nine addiction treatment organizations were randomly assigned to either NIATx1 (active implementation strategy) or NIATx2 (waitlist control). The Dual Diagnosis Capability in Addiction Treatment Index was used to evaluate organizations' capability to provide integrated care. The NIATx Stages of Implementation Completion scale was used to assess participation in and adherence to the NIATx implementation process. Linear mixed-effects modeling was used to evaluate changes from baseline to end of the sustainment period.
RESULTS


Both cohorts sustained their capability to provide integrated treatment services. Both groups achieved successful implementation and sustained integrated services to a similar degree, regardless of sustainment year. Sustainment did not vary as a function of NIATx adherence.
CONCLUSIONS


The delivery of integrated treatment services was sustained for 2 years after receipt of active implementation support. Future research should consider how contextual factors may predict, mediate, and moderate sustainment outcomes.",2022,"Sustainment did not vary as a function of NIATx adherence.
",['Forty-nine addiction treatment organizations'],['NIATx1 (active implementation strategy) or NIATx2 (waitlist control'],[],"[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],49.0,0.0175687,"Sustainment did not vary as a function of NIATx adherence.
","[{'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Chokron Garneau', 'Affiliation': 'Center for Behavioral Health Services and Implementation Research, Division of Public Health and Population Sciences (Chokron Garneau, Assefa, McGovern) and Center for Interdisciplinary Brain Sciences Research (Jo), Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California; School of Pharmacy, Social and Administrative Sciences Division, University of Wisconsin-Madison, Madison (Ford); Oregon Social Learning Center, Eugene (Saldana).'}, {'ForeName': 'Mehret T', 'Initials': 'MT', 'LastName': 'Assefa', 'Affiliation': 'Center for Behavioral Health Services and Implementation Research, Division of Public Health and Population Sciences (Chokron Garneau, Assefa, McGovern) and Center for Interdisciplinary Brain Sciences Research (Jo), Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California; School of Pharmacy, Social and Administrative Sciences Division, University of Wisconsin-Madison, Madison (Ford); Oregon Social Learning Center, Eugene (Saldana).'}, {'ForeName': 'Booil', 'Initials': 'B', 'LastName': 'Jo', 'Affiliation': 'Center for Behavioral Health Services and Implementation Research, Division of Public Health and Population Sciences (Chokron Garneau, Assefa, McGovern) and Center for Interdisciplinary Brain Sciences Research (Jo), Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California; School of Pharmacy, Social and Administrative Sciences Division, University of Wisconsin-Madison, Madison (Ford); Oregon Social Learning Center, Eugene (Saldana).'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Ford', 'Affiliation': 'Center for Behavioral Health Services and Implementation Research, Division of Public Health and Population Sciences (Chokron Garneau, Assefa, McGovern) and Center for Interdisciplinary Brain Sciences Research (Jo), Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California; School of Pharmacy, Social and Administrative Sciences Division, University of Wisconsin-Madison, Madison (Ford); Oregon Social Learning Center, Eugene (Saldana).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Saldana', 'Affiliation': 'Center for Behavioral Health Services and Implementation Research, Division of Public Health and Population Sciences (Chokron Garneau, Assefa, McGovern) and Center for Interdisciplinary Brain Sciences Research (Jo), Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California; School of Pharmacy, Social and Administrative Sciences Division, University of Wisconsin-Madison, Madison (Ford); Oregon Social Learning Center, Eugene (Saldana).'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'McGovern', 'Affiliation': 'Center for Behavioral Health Services and Implementation Research, Division of Public Health and Population Sciences (Chokron Garneau, Assefa, McGovern) and Center for Interdisciplinary Brain Sciences Research (Jo), Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California; School of Pharmacy, Social and Administrative Sciences Division, University of Wisconsin-Madison, Madison (Ford); Oregon Social Learning Center, Eugene (Saldana).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.202000293']
651,34325037,Factors associated with paid employment 12 months after stroke in A Very Early Rehabilitation Trial (AVERT).,"BACKGROUND


Returning to work is an important outcome for stroke survivors.
OBJECTIVES


This sub-study of a randomised controlled trial aimed to provide characteristics of working-age stroke participants and identify factors associated with return to work at 12 months.
METHODS


We used paid employment data collected as part of A Very Early Rehabilitation Trial (AVERT, n=2104), an international randomised controlled trial studying the effects of very early mobilisation after stroke at 56 acute stroke units across Australia, New Zealand, the United Kingdom, Malaysia and Singapore. For the present analysis, data for trial participants < 65 years old were included if they were working at the time of stroke and had complete 12-month return-to-work data. The primary outcome was 12-month return to paid work. Univariable and multivariable logistic regression analyses were conducted to determine the association of multiple factors with return to work.
RESULTS


In total, 376 AVERT participants met the inclusion criteria for this sub-study. By 12 months, 221 (59%) participants had returned to work at a median of 38 hr per week. Similar rates were found across geographic regions. On univariable analysis, the odds of returning to paid employment were increased with younger age (OR per year 0.95, 95%CI 0.92-0.97), no previous diabetes (0.4, 0.24-0.67), lower stroke severity (OR per National Institutes of Health Stroke Scale point 0.82, 0.78-0.86), less 3-month depressive traits (Irritability Depression Anxiety [IDA] scale) (OR per IDA point 0.87, 0.80-0.93), less 3-month disability (modified Rankin Scale), and prior full-time work (2.04, 1.23-3.38). On multivariable analysis, return to work remained associated with younger age (OR 0.94, 95%CI 0.91-0.98), lower stroke severity (0.92, 0.86-0.99), prior full-time work (2.33, 1.24-4.40), and less 3-month disability.
CONCLUSIONS


Return to work at 12 months after stroke was associated with young age, acute stroke severity, 3-month disability and full-time employment before stroke. Greater understanding of this topic could help in developing programs to support successful resumption of work post-stroke.",2021,"On multivariable analysis, return to work remained associated with younger age (OR 0.94, 95%CI 0.91-0.98), lower stroke severity (0.92, 0.86-0.99), prior full-time work (2.33, 1.24-4.40), and less 3-month disability.
","['trial participants < 65 years old were included if they were working at the time of stroke and had complete 12-month return-to-work data', '56 acute stroke units across Australia, New Zealand, the United Kingdom, Malaysia and Singapore', '376 AVERT participants met the inclusion criteria for this sub-study']",[],"['3-month depressive traits (Irritability Depression Anxiety [IDA] scale', '12-month return to paid work', '3-month disability (modified Rankin Scale), and prior full-time work', 'lower stroke severity', 'odds of returning to paid employment']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0451107', 'cui_str': 'Depression anxiety scale'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1320371', 'cui_str': 'In paid employment'}]",376.0,0.2042,"On multivariable analysis, return to work remained associated with younger age (OR 0.94, 95%CI 0.91-0.98), lower stroke severity (0.92, 0.86-0.99), prior full-time work (2.33, 1.24-4.40), and less 3-month disability.
","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cain', 'Affiliation': 'Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Collier', 'Affiliation': 'Stroke, Florey Institute of Neuroscience and Mental Health, 245 Burgundy Street, Heidelberg, Victoria 3084, Australia.'}, {'ForeName': 'Lilian B', 'Initials': 'LB', 'LastName': 'Carvalho', 'Affiliation': 'Stroke, Florey Institute of Neuroscience and Mental Health, 245 Burgundy Street, Heidelberg, Victoria 3084, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Borschmann', 'Affiliation': 'Stroke, Florey Institute of Neuroscience and Mental Health, 245 Burgundy Street, Heidelberg, Victoria 3084, Australia.'}, {'ForeName': 'Marj', 'Initials': 'M', 'LastName': 'Moodie', 'Affiliation': 'Deakin Health Economics, Institute for Health Transformation, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'Austin Health, Heidelberg, Victoria, Australia; Stroke, Florey Institute of Neuroscience and Mental Health, 245 Burgundy Street, Heidelberg, Victoria 3084, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bernhardt', 'Affiliation': 'Stroke, Florey Institute of Neuroscience and Mental Health, 245 Burgundy Street, Heidelberg, Victoria 3084, Australia. Electronic address: julie.bernhardt@florey.edu.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2021.101565']
652,34333391,The effect of milk and rapeseed protein on growth factors in 7-8 year-old healthy children - A randomized controlled trial.,"OBJECTIVE


Milk protein may stimulate linear growth through insulin-like growth factor-1 (IGF-1). However, the effect of plant proteins on growth factors is largely unknown. This study assesses the effect of combinations of milk and rapeseed protein versus milk protein alone on growth factors in children.
DESIGN


An exploratory 3-armed randomized, double-blind, controlled trial was conducted in 129 healthy 7-8 year-old Danish children. Children received 35 g milk and rapeseed protein (ratio 54:46 or 30:70) or 35 g milk protein per day for 4 weeks. The primary outcome was difference in IGF-1 changes between intervention groups after 4 weeks. Secondary outcomes included changes in IGF-1 after 1 week and changes in insulin-like growth factor binding protein-3 (IGFBP-3), IGF-1/IGFBP-3, insulin, height, weight and body composition after 1 and 4 weeks. Results were analysed by multiple linear mixed-effect models.
RESULTS


There were no differences in changes of plasma IGF-1, insulin-like growth factor binding protein-3 (IGFBP-3), IGF-1/IGFBP-3 ratio or insulin between groups after 1 or 4 weeks based on 89 complete cases (P > 0.10). IGF-1 increased by 13.7 (95% CI 9.7;17.7) ng/mL and 18.0 (14.0;22.0) ng/mL from baseline to week 1 and 4, respectively, a 16% increase during the intervention. Similarly, insulin increased by 31% (14; 50) and 33% (16; 53) from baseline to week 1 and 4. Fat-free mass index (FFMI) increments were higher with milk alone than rapeseed blends (P < 0.05), coinciding with a trend towards a lower height increment. Body mass index increased within all groups (P < 0.05), mainly due to an increase in FFMI (P < 0.01).
CONCLUSION


There were no differences in changes of growth factors between the combinations of milk and rapeseed protein and milk protein alone in healthy, well-nourished children with a habitual intake of milk. Within groups, growth factors increased considerably. Future studies are needed to investigate how intakes of plant and animal proteins affect childhood growth.",2021,"Body mass index increased within all groups (P < 0.05), mainly due to an increase in FFMI (P ","['children', '7-8\xa0year-old healthy children', '129 healthy 7-8\xa0year-old Danish children']","['milk and rapeseed protein', '35\xa0g milk and rapeseed protein (ratio 54:46 or 30:70) or 35\xa0g milk protein', 'milk and rapeseed protein versus milk protein alone']","['IGF-1', 'changes in IGF-1 after 1\xa0week and changes in insulin-like growth factor binding protein-3 (IGFBP-3), IGF-1/IGFBP-3, insulin, height, weight and body composition after 1 and 4\xa0weeks', 'plasma IGF-1, insulin-like growth factor binding protein-3 (IGFBP-3), IGF-1/IGFBP-3 ratio or insulin', 'Body mass index', 'growth factors', 'FFMI (P', 'Fat-free mass index (FFMI) increments', 'IGF-1 changes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0034670', 'cui_str': 'Brassica rapa'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026138', 'cui_str': 'Milk protein'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0443625', 'cui_str': 'Binding protein 3'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",129.0,0.0846779,"Body mass index increased within all groups (P < 0.05), mainly due to an increase in FFMI (P ","[{'ForeName': 'Benedikte', 'Initials': 'B', 'LastName': 'Grenov', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark. Electronic address: bgr@nexs.ku.dk.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Larnkjær', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark. Electronic address: ala@nexs.ku.dk.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark. Electronic address: ritz@nexs.ku.dk.'}, {'ForeName': 'Kim F', 'Initials': 'KF', 'LastName': 'Michaelsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark. Electronic address: kfm@nexs.ku.dk.'}, {'ForeName': 'Camilla T', 'Initials': 'CT', 'LastName': 'Damsgaard', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark. Electronic address: ctd@nexs.ku.dk.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mølgaard', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark. Electronic address: cm@nexs.ku.dk.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2021.101418']
653,34340839,Effect of erector spinae plane block on the postoperative quality of recovery after laparoscopic cholecystectomy: a prospective double-blind study.,"BACKGROUND


Laparoscopic cholecystectomy is a common surgical procedure that frequently results in substantial postoperative pain. Erector spinae plane block (ESPB) has been shown to have beneficial postoperative analgesic effects when used as a part of multimodal analgesia. The aim of this study was to determine whether ESPB improves postoperative recovery quality in patients undergoing laparoscopic cholecystectomy. Evaluation of the effects of ESPB on postoperative pain, opioid consumption, and nausea and vomiting was the secondary objective.
METHODS


In this prospective double-blind study, 82 patients undergoing laparoscopic cholecystectomy were randomised into one of two groups: a standard multimodal analgesic regimen in Group N (control) or an ESPB was performed in Group E. Preoperative and postoperative recovery quality was measured using the 40-item quality of recovery (QoR-40) questionnaire; postoperative pain was evaluated using the numerical rating scale scores.
RESULTS


Postoperative mean (standard deviation) QoR-40 scores were higher in Group E (181 [7.3]) than in Group N (167 [11.4]); P<0.01. With repeated measures, a significant effect of group and time was demonstrated for the global QoR-40 score, P<0.01, indicating better quality of recovery in Group E. Pain scores were significantly lower in Group E than in Group N, both during resting and motion at T1-T8 times (P<0.01 at each time). The total amount of tramadol consumed in the first 24 h was lower in Group E [median 0 mg, inter-quartile range (IQR) (0-140)], than in Group N [median 180 mg, IQR (150-240); P<0.01].
CONCLUSIONS


ESPB improved postoperative quality of recovery in patients undergoing laparoscopic cholecystectomy. Moreover, ESPB reduced pain scores and cumulative opioid consumption.
CLINICAL TRIAL REGISTRATION


NCT04112394.",2021,QoR-40 scores were higher in Group E (181 [7.3]) than in Group N (167 [11.4]); P<0.01.,"['82 patients undergoing', 'patients undergoing laparoscopic cholecystectomy']","['ESPB', 'Laparoscopic cholecystectomy', 'standard multimodal analgesic regimen in Group N (control) or an ESPB', 'Erector spinae plane block (ESPB', 'laparoscopic cholecystectomy', 'erector spinae plane block']","['40-item quality of recovery (QoR-40) questionnaire; postoperative pain', 'global QoR-40 score', 'postoperative pain, opioid consumption, and nausea and vomiting', 'ESPB reduced pain scores and cumulative opioid consumption', 'QoR-40 scores', 'numerical rating scale scores', 'postoperative quality of recovery', 'Postoperative mean (standard deviation', 'quality of recovery in Group E. Pain scores', 'postoperative recovery quality', 'total amount of tramadol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0441848', 'cui_str': 'Group N'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]",82.0,0.101684,QoR-40 scores were higher in Group E (181 [7.3]) than in Group N (167 [11.4]); P<0.01.,"[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Canıtez', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Abdulkadir Yuksel City Hospital, Gaziantep, Turkey.'}, {'ForeName': 'Betul', 'Initials': 'B', 'LastName': 'Kozanhan', 'Affiliation': 'Department of Anaesthesiology and Reanimation, University of Health Sciences, Konya Education and Research Hospital, Konya, Turkey. Electronic address: betulkozanhan@gmail.com.'}, {'ForeName': 'Nergis', 'Initials': 'N', 'LastName': 'Aksoy', 'Affiliation': 'Department of General Surgery, University of Health Sciences, Konya Education and Research Hospital, Konya, Turkey.'}, {'ForeName': 'Munise', 'Initials': 'M', 'LastName': 'Yildiz', 'Affiliation': 'Department of Anaesthesiology and Reanimation, University of Health Sciences, Konya Education and Research Hospital, Konya, Turkey.'}, {'ForeName': 'Mahmut S', 'Initials': 'MS', 'LastName': 'Tutar', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Konya Numune State Hospital, Konya, Turkey.'}]",British journal of anaesthesia,['10.1016/j.bja.2021.06.030']
654,34343621,An Early Palliative Care Telehealth Coaching Intervention to Enhance Advanced Cancer Family Caregivers' Decision Support Skills: The CASCADE Pilot Factorial Trial.,"CONTEXT


Patients with advanced cancer often involve family caregivers in health-related decision-making from diagnosis to end-of-life; however, few interventions have been developed to enhance caregiver decision support skills.
OBJECTIVES


Assess the feasibility, acceptability, and potential efficacy of individual intervention components of CASCADE (CAre Supporters Coached to be Adept DEcision Partners), an early telehealth, palliative care coach-led decision support training intervention for caregivers.
METHODS


Pilot factorial trial using the multiphase optimization strategy (October 2019-October 2020). Family caregivers and their care recipients with newly-diagnosed advanced cancer (n = 46 dyads) were randomized to1 of 8 experimental conditions that included a combination of one of the following three CASCADE components: 1) effective decision support psychoeducation; 2) decision support communication training; and 3) Ottawa Decision Guide training. Feasibility was assessed by completion of sessions and questionnaires (predefined as ≥80%). Acceptability was determined through postintervention interviews and participants' ratings of their likelihood to recommend. Measures of effective decision support and caregiver and patient distress were collected at Twelve and Twenty four weeks.
RESULTS


Caregiver participants completed 78% of intervention sessions and 81% of questionnaires; patients completed 80% of questionnaires. Across conditions, average caregiver ratings for recommending the program to others was 9.9 on a scale from 1-Not at all likely to 10-Extremely likely. Individual CASCADE components were observed to have potential benefit for effective decision support and caregiver distress.
CONCLUSION


We successfully piloted a factorial trial design to examine components of a novel intervention to enhance the decision support skills of advanced cancer family caregivers. A fully-powered factorial trial is warranted.
KEY MESSAGE


We pilot tested components of CASCADE, an early palliative care decision support training intervention for family caregivers of patients with advanced cancer. CASCADE components were acceptable and the trial design feasible, providing promising future directions for palliative care intervention development and testing. Pilot results will inform a fully-powered trial.",2022,We successfully piloted a factorial trial design to examine components of a novel intervention to enhance the decision support skills of advanced cancer family caregivers.,"[""advanced cancer family caregivers' decision support skills"", 'advanced cancer family caregivers', 'family caregivers of patients with advanced cancer', 'Family caregivers and their care recipients with newly-diagnosed advanced cancer (N=46 dyads', 'Patients with advanced cancer often involve family caregivers in health-related decision-making from diagnosis to end-of-life']","['individual intervention components of CASCADE', 'palliative care telehealth coaching intervention', 'palliative care decision support training intervention', 'effective decision support psychoeducation; 2) decision support communication training; and 3) Ottawa Decision Guide training']","['feasibility, acceptability, and potential efficacy', 'effective decision support and caregiver and patient distress', 'Acceptability']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.062569,We successfully piloted a factorial trial design to examine components of a novel intervention to enhance the decision support skills of advanced cancer family caregivers.,"[{'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (J.N.D.O., R.D.W., A.A., B.A.H., E.R.C., A.B., C.D., R.T., S.G., S.E., P.M., M.A.B.), Birmingham, Alabama, USA; Division of Gerontology, Geriatrics, and Palliative Care, School of Medicine, University of Alabama at Birmingham (J.N.D.O., M.A.B.), Birmingham, Alabama, USA; Center for Palliative and Supportive Care, University of Alabama at Birmingham (J.N.D.O., M.A.B.), Birmingham, Alabama, USA. Electronic address: dionneod@uab.edu.'}, {'ForeName': 'Rachel D', 'Initials': 'RD', 'LastName': 'Wells', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (J.N.D.O., R.D.W., A.A., B.A.H., E.R.C., A.B., C.D., R.T., S.G., S.E., P.M., M.A.B.), Birmingham, Alabama, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Guastaferro', 'Affiliation': 'Methodology Center, Pennsylvania State University (K.G.), University Park, Pennsylvania, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (J.N.D.O., R.D.W., A.A., B.A.H., E.R.C., A.B., C.D., R.T., S.G., S.E., P.M., M.A.B.), Birmingham, Alabama, USA.'}, {'ForeName': 'Bailey A', 'Initials': 'BA', 'LastName': 'Hendricks', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (J.N.D.O., R.D.W., A.A., B.A.H., E.R.C., A.B., C.D., R.T., S.G., S.E., P.M., M.A.B.), Birmingham, Alabama, USA.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Currie', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (J.N.D.O., R.D.W., A.A., B.A.H., E.R.C., A.B., C.D., R.T., S.G., S.E., P.M., M.A.B.), Birmingham, Alabama, USA.'}, {'ForeName': 'Avery', 'Initials': 'A', 'LastName': 'Bechthold', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (J.N.D.O., R.D.W., A.A., B.A.H., E.R.C., A.B., C.D., R.T., S.G., S.E., P.M., M.A.B.), Birmingham, Alabama, USA.'}, {'ForeName': 'Chinara', 'Initials': 'C', 'LastName': 'Dosse', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (J.N.D.O., R.D.W., A.A., B.A.H., E.R.C., A.B., C.D., R.T., S.G., S.E., P.M., M.A.B.), Birmingham, Alabama, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (J.N.D.O., R.D.W., A.A., B.A.H., E.R.C., A.B., C.D., R.T., S.G., S.E., P.M., M.A.B.), Birmingham, Alabama, USA.'}, {'ForeName': 'Rhiannon D', 'Initials': 'RD', 'LastName': 'Reed', 'Affiliation': 'Comprehensive Transplant Institute, University of Alabama at Birmingham (R.D.R.), Birmingham, Alabama, USA.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Harrell', 'Affiliation': 'Department of Psychology, University of Alabama (E.R.H.), Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Shena', 'Initials': 'S', 'LastName': 'Gazaway', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (J.N.D.O., R.D.W., A.A., B.A.H., E.R.C., A.B., C.D., R.T., S.G., S.E., P.M., M.A.B.), Birmingham, Alabama, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Engler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (J.N.D.O., R.D.W., A.A., B.A.H., E.R.C., A.B., C.D., R.T., S.G., S.E., P.M., M.A.B.), Birmingham, Alabama, USA.'}, {'ForeName': 'Peg', 'Initials': 'P', 'LastName': 'McKie', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (J.N.D.O., R.D.W., A.A., B.A.H., E.R.C., A.B., C.D., R.T., S.G., S.E., P.M., M.A.B.), Birmingham, Alabama, USA.'}, {'ForeName': 'Grant R', 'Initials': 'GR', 'LastName': 'Williams', 'Affiliation': 'School of Medicine, Division of Hematology-Oncology, University of Alabama at Birmingham (G.R.W.), Birmingham, Alabama, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sudore', 'Affiliation': 'School of Medicine, Division of Geriatrics, University of California (R.S.), San Francisco, California, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rini', 'Affiliation': 'Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University (C.R.), Chicago, Illinois, USA.'}, {'ForeName': 'Abby R', 'Initials': 'AR', 'LastName': 'Rosenberg', 'Affiliation': ""Division of Hematology-Oncology, Department of Pediatrics, School of Medicine, University of Washington (A.R.R.), Seattle, Washington, USA; Palliative Care and Resilience Lab, Seattle Children's Research Institute (A.R.R.), Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington (A.R.R.), Seattle, Washington, USA.""}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Bakitas', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (J.N.D.O., R.D.W., A.A., B.A.H., E.R.C., A.B., C.D., R.T., S.G., S.E., P.M., M.A.B.), Birmingham, Alabama, USA; Division of Gerontology, Geriatrics, and Palliative Care, School of Medicine, University of Alabama at Birmingham (J.N.D.O., M.A.B.), Birmingham, Alabama, USA; Center for Palliative and Supportive Care, University of Alabama at Birmingham (J.N.D.O., M.A.B.), Birmingham, Alabama, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2021.07.023']
655,34343620,A Randomized Controlled Pilot Study of Yoga Skills Training Versus an Attention Control Delivered During Chemotherapy Administration.,"CONTEXT


It is important to address fatigue and co-occurring symptoms during chemotherapy to preserve quality of life in patients with gastrointestinal (GI) cancer.
OBJECTIVE


To conduct a randomized controlled pilot study of a Yoga Skills Training (YST) intervention compared to an attention control (AC) among adults diagnosed with GI cancer.
METHODS


YST consisted of four 30-minute sessions delivered individually during chemotherapy plus home practice. AC provided empathic attention plus home diaries. Patient-reported (PROMIS T-score) assessments of fatigue, depressive symptoms, sleep disturbances, and psychological stress (Perceived Stress Scale) were collected at chemotherapy visits: baseline, Week 8, Week 10 and Week 14, and analyzed using a mixed effects model. Inflammatory cytokines were assessed at baseline and Week 10.
RESULTS


Forty-four of 77 adults approached agreed to participate (57%; YST n = 23; AC n = 21). Participants' mean age was 58 years and 48% were men. Participants randomized to YST reported a larger decline in fatigue (-2.4 difference, d = 0.30) and depressive symptoms (-2.5 difference, d = 0.30) than AC participants from baseline to Week 10 and sleep disturbances at Week 8 (-3.9 difference, d = 0.50). Differences in magnitude of change in symptoms were consistent with or exceeded a minimally important difference. Psychological stress decreased more in the AC at Week 10 (d = 0.30). Reductions in inflammatory cytokines (IL-6, sTNF R1) were larger in the YST group than AC.
CONCLUSION


YST showed promise for improving fatigue, depressive symptoms, sleep disturbances, and inflammation. YST is also feasible and reaches patients underrepresented in yoga research (i.e., GI cancer, men), thus warranting further examination.",2022,"Reductions in inflammatory cytokines (IL-6, sTNF R1) were larger in the YST group than AC.
","['adults diagnosed with GI cancer', ""Participants' mean age was 58 years and 48% were men"", 'patients with gastrointestinal (GI) cancer', 'Forty-four of 77 adults approached agreed to participate (57']","['attention control (AC', 'Yoga Skills Training (YST) intervention', 'chemotherapy plus home practice', 'YST', 'Yoga Skills Training']","['Inflammatory cytokines', 'sleep disturbances', 'Psychological stress', 'inflammatory cytokines (IL-6, sTNF R1', 'depressive symptoms', 'Patient-reported (PROMIS T-score) assessments of fatigue, depressive symptoms, sleep disturbances, and psychological stress (Perceived Stress Scale', 'fatigue', 'fatigue, depressive symptoms, sleep disturbances, and inflammation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C4041113', 'cui_str': 'Assessment of fatigue'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",77.0,0.205742,"Reductions in inflammatory cytokines (IL-6, sTNF R1) were larger in the YST group than AC.
","[{'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Sohl', 'Affiliation': 'Wake Forest School of Medicine (S.J.S., J.A.T., E.N.J., C.R.L., K.C.A., B.N., N.E.A, L.I.W.), Winston-Salem, North Carolina, USA. Electronic address: ssohl@wakehealth.edu.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Tooze', 'Affiliation': 'Wake Forest School of Medicine (S.J.S., J.A.T., E.N.J., C.R.L., K.C.A., B.N., N.E.A, L.I.W.), Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Emily Nance', 'Initials': 'EN', 'LastName': 'Johnson', 'Affiliation': 'Wake Forest School of Medicine (S.J.S., J.A.T., E.N.J., C.R.L., K.C.A., B.N., N.E.A, L.I.W.), Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Sheila H', 'Initials': 'SH', 'LastName': 'Ridner', 'Affiliation': 'Vanderbilt University School of Nursing (S.H.R.), Nashville, Tennessee, USA.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Rothman', 'Affiliation': 'Vanderbilt University School of Medicine (R.L.R.), Nashville, Tennessee, USA.'}, {'ForeName': 'Caio Rocha', 'Initials': 'CR', 'LastName': 'Lima', 'Affiliation': 'Wake Forest School of Medicine (S.J.S., J.A.T., E.N.J., C.R.L., K.C.A., B.N., N.E.A, L.I.W.), Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Katherine C', 'Initials': 'KC', 'LastName': 'Ansley', 'Affiliation': 'Wake Forest School of Medicine (S.J.S., J.A.T., E.N.J., C.R.L., K.C.A., B.N., N.E.A, L.I.W.), Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wheeler', 'Affiliation': 'California State University (A.W.), San Bernardino, California, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Nicklas', 'Affiliation': 'Wake Forest School of Medicine (S.J.S., J.A.T., E.N.J., C.R.L., K.C.A., B.N., N.E.A, L.I.W.), Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Avis', 'Affiliation': 'Wake Forest School of Medicine (S.J.S., J.A.T., E.N.J., C.R.L., K.C.A., B.N., N.E.A, L.I.W.), Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest School of Medicine (S.J.S., J.A.T., E.N.J., C.R.L., K.C.A., B.N., N.E.A, L.I.W.), Winston-Salem, North Carolina, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2021.07.022']
656,34320288,A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection.,"BACKGROUND


Primary cytomegalovirus (CMV) infection during pregnancy carries a risk of congenital infection and possible severe sequelae. There is no established intervention for preventing congenital CMV infection.
METHODS


In this multicenter, double-blind trial, pregnant women with primary CMV infection diagnosed before 24 weeks' gestation were randomly assigned to receive a monthly infusion of CMV hyperimmune globulin (at a dose of 100 mg per kilogram of body weight) or matching placebo until delivery. The primary outcome was a composite of congenital CMV infection or fetal or neonatal death if CMV testing of the fetus or neonate was not performed.
RESULTS


From 2012 to 2018, a total of 206,082 pregnant women were screened for primary CMV infection before 23 weeks of gestation; of the 712 participants (0.35%) who tested positive, 399 (56%) underwent randomization. The trial was stopped early for futility. Data on the primary outcome were available for 394 participants; a primary outcome event occurred in the fetus or neonate of 46 of 203 women (22.7%) in the group that received hyperimmune globulin and of 37 of 191 women (19.4%) in the placebo group (relative risk, 1.17; 95% confidence interval [CI] 0.80 to 1.72; P = 0.42). Death occurred in 4.9% of fetuses or neonates in the hyperimmune globulin group and in 2.6% in the placebo group (relative risk, 1.88; 95% CI, 0.66 to 5.41), preterm birth occurred in 12.2% and 8.3%, respectively (relative risk, 1.47; 95% CI, 0.81 to 2.67), and birth weight below the 5th percentile occurred in 10.3% and 5.4% (relative risk, 1.92; 95% CI, 0.92 to 3.99). One participant in the hyperimmune globulin group had a severe allergic reaction to the first infusion. Participants who received hyperimmune globulin had a higher incidence of headaches and shaking chills while receiving infusions than participants who received placebo.
CONCLUSIONS


Among pregnant women, administration of CMV hyperimmune globulin starting before 24 weeks' gestation did not result in a lower incidence of a composite of congenital CMV infection or perinatal death than placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences; ClinicalTrials.gov number, NCT01376778.).",2021,"Participants who received hyperimmune globulin had a higher incidence of headaches and shaking chills while receiving infusions than participants who received placebo.
","['From 2012 to 2018', '206,082 pregnant women were screened for primary CMV infection before 23 weeks of gestation; of the 712 participants (0.35%) who tested positive, 399 (56%) underwent randomization', ""pregnant women with primary CMV infection diagnosed before 24 weeks' gestation""]","['placebo', 'CMV hyperimmune globulin', 'Hyperimmune Globulin', 'hyperimmune globulin']","['birth weight', 'severe allergic reaction', 'Congenital Cytomegalovirus Infection', 'preterm birth', 'headaches and shaking chills', 'congenital CMV infection or perinatal death', 'fetus or neonate', 'composite of congenital CMV infection or fetal or neonatal death if CMV testing of the fetus or neonate was not performed', 'Death']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0017649', 'cui_str': 'Globulin'}]","[{'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0158945', 'cui_str': 'Congenital cytomegalovirus infection'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0445106', 'cui_str': 'Not performed'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",206082.0,0.886239,"Participants who received hyperimmune globulin had a higher incidence of headaches and shaking chills while receiving infusions than participants who received placebo.
","[{'ForeName': 'Brenna L', 'Initials': 'BL', 'LastName': 'Hughes', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Clifton', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Mara J', 'Initials': 'MJ', 'LastName': 'Dinsmoor', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pass', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Allard', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Lida M', 'Initials': 'LM', 'LastName': 'Fette', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Gyamfi-Bannerman', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Varner', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Goodnight', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Maged M', 'Initials': 'MM', 'LastName': 'Costantine', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Gibbs', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Yasser Y', 'Initials': 'YY', 'LastName': 'El-Sayed', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Parry', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Napolitano', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': ""From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1913569']
657,34320250,"Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy.","BACKGROUND


The benefit of daily administration of Peanut (Arachis hypogaea) Allergen Powder-dnfp (PTAH)-formerly AR101-has been established in clinical trials, but limited data past the first year of treatment are available. This longitudinal analysis aimed to explore the impact of continued PTAH therapeutic maintenance dosing (300 mg/day) on efficacy, safety/tolerability, and food allergy-related quality of life.
METHODS


We present a subset analysis of PALISADE-ARC004 participants (aged 4-17 years) who received 300 mg PTAH daily for a total of ~1.5 (Group A, n = 110) or ~2 years (Group B, n = 32). Safety assessments included monitoring the incidence of adverse events (AEs), accidental exposures to food allergens, and adrenaline use. Efficacy was assessed by double-blind, placebo-controlled food challenge (DBPCFC); skin prick testing; peanut-specific antibody assays; and Food Allergy Quality of Life Questionnaire (FAQLQ) and Food Allergy Independent Measure (FAIM) scores.
RESULTS


Continued maintenance with PTAH increased participants' ability to tolerate peanut protein: 48.1% of completers in Group A (n = 50/104) and 80.8% in Group B (n = 21/26) tolerated 2000 mg peanut protein at exit DBPCFC without dose-limiting symptoms. Immune biomarkers showed a pattern consistent with treatment-induced desensitization. Among PTAH-continuing participants, the overall and treatment-related exposure-adjusted AE rate decreased throughout the intervention period in both groups. Clinically meaningful improvements in FAQLQ and FAIM scores over time suggest a potential link between increased desensitization as determined by the DBPCFC and improved quality of life.
CONCLUSIONS


These results demonstrate that daily PTAH treatment for peanut allergy beyond 1 year leads to an improved safety/tolerability profile and continued clinical and immunological response.",2022,"Clinically meaningful improvements in FAQLQ and FAIM scores over time suggest a potential link between increased desensitisation as determined by the DBPCFC and improved quality of life.
","['children with peanut allergy', 'ARC004 participants (aged 4-17 years) who received 300 mg PTAH daily for a total of ~1.5 (Group A, n=110) or ~2 years (Group B, n=32']","['PTAH', 'Peanut (Arachis hypogaea', 'placebo-controlled food challenge (DBPCFC); skin prick testing; peanut-specific antibody assays']","['exposure-adjusted AE rate', 'Food Allergy Quality of Life Questionnaire (FAQLQ) and Food Allergy Independent Measure (FAIM) scores', 'FAQLQ and FAIM scores', 'safety/tolerability profile and continued clinical and immunological response', 'efficacy, safety/tolerability, and food allergy-related quality of life', 'Efficacy', 'quality of life', 'efficacy, safety, and quality of life', 'adverse events (AEs), accidental exposures to food allergens, and adrenaline use']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0450027', 'cui_str': 'Accidental exposure'}, {'cui': 'C1320239', 'cui_str': 'Food allergen'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.134411,"Clinically meaningful improvements in FAQLQ and FAIM scores over time suggest a potential link between increased desensitisation as determined by the DBPCFC and improved quality of life.
","[{'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fernandez-Rivas', 'Affiliation': 'Allergy Department, Hospital Clinico San Carlos, IdISSC, Madrid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vereda', 'Affiliation': 'Aimmune Therapeutics, London, UK.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Vickery', 'Affiliation': 'Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Vibha', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': ""Department of Paediatric Allergy and Immunology, Royal Manchester Children's Hospital, Manchester, UK.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Nilsson', 'Affiliation': ""Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Sachs' Children and Youth Hospital, Stockholm, Sweden.""}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Muraro', 'Affiliation': 'Food Allergy Referral Centre Veneto Region, Department of Woman and Child Health, Padua University Hospital, Padua, Italy.'}, {'ForeName': ""Jonathan O'B"", 'Initials': 'JO', 'LastName': 'Hourihane', 'Affiliation': 'Paediatrics and Child Health, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'DunnGalvin', 'Affiliation': 'Infant Centre and Pediatrics and Child Health, University College Cork, and HRB Clinical Research Facility-Cork, Cork, Ireland.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'du Toit', 'Affiliation': ""Guy's and St. Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Blumchen', 'Affiliation': 'Division of Allergology, Pneumology and Cystic Fibrosis, Department of Children and Adolescent Medicine, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Beyer', 'Affiliation': 'Division of Pulmonology, Immunology and Critical Care Medicine, Department of Pediatrics, Charité Universtãtsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Aimmune Therapeutics, Brisbane, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ryan', 'Affiliation': 'Aimmune Therapeutics, London, UK.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Adelman', 'Affiliation': 'Aimmune Therapeutics, Brisbane, California, USA.'}, {'ForeName': 'Stacie M', 'Initials': 'SM', 'LastName': 'Jones', 'Affiliation': ""University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Arkansas, USA.""}]",Allergy,['10.1111/all.15027']
658,34337726,"Efficacy of intravenous perioperative parecoxib administration in the surgical fixation of unstable ankle fracture: a prospective, double-blinded, randomized, placebo-controlled trial.","OBJECTIVE


Little is known about the efficacy of perioperative intravenous (IV) non-opioid medication administration in patients undergoing orthopedic surgery. The objective of this study was to determine the efficacy of perioperative parecoxib in patients with unstable ankle fractures who were scheduled to undergo surgery.
PATIENTS AND METHODS


In this double-blinded, prospective, randomized controlled trial, 40 patients who underwent open reduction and internal fixation for unstable ankle fractures were randomly allocated to the parecoxib group (parecoxib 40 mg IV 30 min before surgery and then 40 mg IV every 12 h for the initial 48 h postoperatively [n=20]) or the placebo group (saline [n=20]). The efficacy of pain control was assessed according to the total morphine used. Pain intensity (at rest/ambulation) and pain relief (at rest/ambulation) were assessed using the verbal numerical rating score (VNRS) and verbal numerical rating percentage (VNRP), respectively. Subjective rating of medication was performed by each patient. All outcomes were recorded by trained personnel who were blinded to the patient group allocation.
RESULTS


The mean patient age was 49.3±18.0 years. There were no significant differences between the two groups in terms of pain intensity, pain relief, patients' subjective ratings of the medication at both the preoperative and postoperative periods, total quantity of morphine used, side effects, and acute complications of surgery (p>0.05). The mean length of hospital stay tended to be shorter in the parecoxib group than in the placebo group (6 vs. 9.9 days; p=0.183).
CONCLUSIONS


Although the perioperative administration of parecoxib did not provide significantly better postoperative pain control or reduce the opioid requirement relative to placebo, its use led to a shorter hospital stay.",2021,"There were no significant differences between the two groups in terms of pain intensity, pain relief, patients' subjective ratings of the medication at both the preoperative and postoperative periods, total quantity of morphine used, side effects, and acute complications of surgery (p>0.05).","['40 patients who underwent open reduction and internal fixation for unstable ankle fractures', 'patients with unstable ankle fractures who were scheduled to undergo surgery', 'unstable ankle fracture', 'patients undergoing orthopedic surgery']","['intravenous perioperative parecoxib', 'parecoxib group (parecoxib', 'placebo group (saline', 'parecoxib', 'perioperative intravenous (IV) non-opioid medication administration', 'placebo', 'perioperative parecoxib']","['Pain intensity', 'verbal numerical rating score (VNRS) and verbal numerical rating percentage (VNRP', ""pain intensity, pain relief, patients' subjective ratings of the medication at both the preoperative and postoperative periods, total quantity of morphine used, side effects, and acute complications of surgery"", 'pain relief', 'Subjective rating of medication', 'efficacy of pain control', 'mean length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",40.0,0.342043,"There were no significant differences between the two groups in terms of pain intensity, pain relief, patients' subjective ratings of the medication at both the preoperative and postoperative periods, total quantity of morphine used, side effects, and acute complications of surgery (p>0.05).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Angthong', 'Affiliation': ""Division of Digital and Innovative Medicine, Faculty of Medicine, King Mongkut's Institute of Technology Ladkrabang, Bangkok, Thailand. Chayanin.an@kmitl.ac.th.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Manuwong', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rajbhandari', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Veljkovic', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202107_26390']
659,34342015,Trajectories of reward availability moderate the impact of brief alcohol interventions on alcohol severity in heavy-drinking young adults.,"BACKGROUND


Behavioral economic theory predicts that low access to environmental reward is a risk factor for alcohol use disorder (AUD). The Substance-Free Activity Session (SFAS) is a behavioral economic supplement to standard brief alcohol interventions that attempts to increase environmental reward and may therefore have beneficial effects, particularly for individuals with low levels of environmental reward.
METHODS


Participants were 393 college students who reported at least 2 heavy-drinking episodes in the past month. Participants were randomly assigned to 1 of 3 conditions following a baseline assessment: a standard alcohol-focused brief motivational intervention plus relaxation training session (BMI + RT), BMI plus Substance-Free Activity Session (BMI + SFAS), or an assessment-only control condition (AO). In a secondary analysis of the data from this study, we used person-centered statistical techniques to describe trajectories of alcohol severity and environmental reward over a 16-month follow-up and examined whether environmental reward levels moderated the effectiveness of the interventions.
RESULTS


Piecewise growth mixture modeling identified 2 trajectories of reward availability: low increasing (LR; n = 120) and high stable (HR; n = 273). Depressive symptoms, cannabis use, sensation seeking, and low life satisfaction were associated with a greater probability of classification in the LR trajectory. Alcohol severity was greater in the LR trajectory than the HR trajectory. For students in the LR trajectory, at 1, 6, and 12 months, BMI + SFAS led to greater increases in reward availability and reduced levels of alcohol severity compared with the BMI + RT and AO conditions and at 16 months compared with AO.
CONCLUSIONS


Young adults with low levels of environmental reward are at heightened risk for greater alcohol severity and may show greater benefit from brief alcohol interventions that focus on increasing substance-free reward than individuals who are not deficient in reward availability.",2021,"For students in the LR trajectory, BMI+SFAS led to greater increases in reward availability and reduced levels of alcohol severity at 1, 6, and 12 months compared to BMI+RT and AO conditions, and also at 16 months compared to AO.
","['Participants were 393 college students who reported at least 2 heavy drinking episodes in the past month', 'individuals with low levels of environmental reward', 'heavy-drinking young adults']","['standard alcohol-focused brief motivational intervention plus relaxation training session (BMI+RT), BMI plus Substance-Free Activity Session (BMI+SFAS), or assessment-only control condition (AO', 'alcohol interventions', 'Substance-Free Activity Session (SFAS', 'BMI+SFAS']","['Alcohol severity', 'Depressive symptoms, cannabis use, sensation-seeking, and low life satisfaction', 'alcohol severity', 'reward availability and reduced levels of alcohol severity']","[{'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556342', 'cui_str': 'Drinking episode'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",393.0,0.0184426,"For students in the LR trajectory, BMI+SFAS led to greater increases in reward availability and reduced levels of alcohol severity at 1, 6, and 12 months compared to BMI+RT and AO conditions, and also at 16 months compared to AO.
","[{'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychology, The University of Memphis, Memphis, Tennessee, USA.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychology, The University of Memphis, Memphis, Tennessee, USA.'}, {'ForeName': 'Keanan J', 'Initials': 'KJ', 'LastName': 'Joyner', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee, Florida, USA.'}, {'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Dennhardt', 'Affiliation': 'Department of Psychology, The University of Memphis, Memphis, Tennessee, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Martens', 'Affiliation': 'Department of Educational, School, and Counseling Psychology, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Borsari', 'Affiliation': 'Mental Health Service (116B, San Francisco VA Health Care System, San Francisco, California, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14681']
660,34342007,The effect of alcohol on mood among males drinking with a platonic friend.,"BACKGROUND


Despite the social nature of most drinking experiences, prior work has largely failed to incorporate social context into the study of alcohol's effects on emotion. The present study provides an initial test of the effect of alcohol on mood among platonic friends drinking together in a non-stress setting. We hypothesized that subjects would report more positive postdrink mood after consuming alcohol than after consuming a nonalcoholic control beverage.
METHODS


Dyads of platonic male friends (n = 36; 55.55% White, 38.88% Asian, 5.55% Black) attended two laboratory-based experimental sessions, wherein their drink conditions (alcohol vs. no alcohol control) were randomized by dyad and counter-balanced across sessions. They reported their mood before and after consuming their beverages together, using the Positive and Negative Affect Schedule and an 8-item mood measure.
RESULTS


As hypothesized, alcohol enhanced positive mood (  β   = 0.26, p < 0.01). Although in the expected direction, the effect of alcohol on negative mood was not significant (  β   = -0.12, p = 0.17). Post hoc analyses revealed that alcohol yielded greater increases in both stimulation (  β     =     0.26    , p = 0.00) and sedation (  β   =   0.40    , p = 0.00) as compared to the control condition.
CONCLUSION


This study highlights the positive mood-enhancing and broader subjective effects of alcohol when drinking with a platonic friend and encourages further consideration of friendship contexts in the examination of alcohol's effects when developing models of the etiology of alcohol use disorder.",2021,"Post-hoc analyses revealed alcohol to yield greater increases in both stimulation (β = .26, p = .00) and sedation (β = .40, p = .00) as compared to the control condition.
","['Dyads of platonic male friends (n = 36; 55.55% White, 38.88% Asian, 5.55% Black) attended two', 'males drinking with a platonic friend']","['alcohol', 'lab-based experimental sessions, wherein their drink conditions (alcohol vs. no-alcohol control']",['negative mood'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.00753939,"Post-hoc analyses revealed alcohol to yield greater increases in both stimulation (β = .26, p = .00) and sedation (β = .40, p = .00) as compared to the control condition.
","[{'ForeName': 'Molly A', 'Initials': 'MA', 'LastName': 'Bowdring', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Sayette', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14682']
661,34350897,Programming Directional Deep Brain Stimulation in Parkinson's Disease: A Randomized Prospective Trial Comparing Early versus Delayed Stimulation Steering.,"INTRODUCTION


Programming directional leads poses new challenges as the optimal strategy is yet to be established. We designed a randomized control study to establish an evidence-based programming algorithm for patients with Parkinson's disease undergoing subthalamic nucleus deep brain stimulation with directional leads.
METHODS


Fourteen consecutive patients were randomized to programming with either early or delayed (i.e., starting with a ""ring mode"") steered stimulation. Motor scores, number of programming visits, calls to the clinic, battery consumption, and stimulation adjustments required were recorded and compared between groups, using the Wilcoxon signed-ranks test, after 3 months of open-label programming.
RESULTS


Thirteen patients (25 electrodes) were included, of which 23 were steerable. Nine out of 14 electrodes allocated to delayed steered stimulation were changed to steered mode due to side effects during the course of the study. No patients (11 electrodes) initially allocated to early steered stimulation were converted to ring mode. The 2 study arms did not differ in any of the considered measures at 3 months.
CONCLUSION


Programming with early or delayed steered stimulation is equally effective in the short term. However, delayed steering is less time consuming and is not always needed.",2021,"The 2 study arms did not differ in any of the considered measures at 3 months.
","[""patients with Parkinson's disease undergoing subthalamic nucleus deep brain stimulation with directional leads"", ""Parkinson's Disease"", 'Fourteen consecutive patients', 'Thirteen patients (25 electrodes) were included, of which 23 were steerable']","['evidence-based programming algorithm', 'Programming Directional Deep Brain Stimulation']","['Motor scores, number of programming visits, calls to the clinic, battery consumption, and stimulation adjustments required']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]",14.0,0.0282058,"The 2 study arms did not differ in any of the considered measures at 3 months.
","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Maciel', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Centre, Toronto Western Hospital, UHN, Toronto, Ontario, Canada.""}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Soh', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Centre, Toronto Western Hospital, UHN, Toronto, Ontario, Canada.""}, {'ForeName': 'Renato P', 'Initials': 'RP', 'LastName': 'Munhoz', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Centre, Toronto Western Hospital, UHN, Toronto, Ontario, Canada.""}, {'ForeName': 'Yu-Yan', 'Initials': 'YY', 'LastName': 'Poon', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Centre, Toronto Western Hospital, UHN, Toronto, Ontario, Canada.""}, {'ForeName': 'Suneil K', 'Initials': 'SK', 'LastName': 'Kalia', 'Affiliation': 'Division of Neurosurgery, Department of Neurosurgery, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Hodaie', 'Affiliation': 'Division of Neurosurgery, Department of Neurosurgery, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Lozano', 'Affiliation': 'Division of Neurosurgery, Department of Neurosurgery, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Fasano', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Centre, Toronto Western Hospital, UHN, Toronto, Ontario, Canada.""}]",Stereotactic and functional neurosurgery,['10.1159/000517054']
662,34331080,"Effects of topiramate on the association between affect, cannabis craving, and cannabis use in the daily life of youth during a randomized clinical trial.","RATIONALE


Topiramate is an anticonvulsant currently under study for treating substance use disorders. Topiramate is thought to reduce substance use by attenuating craving and the rewarding effects of acute substance use through its concurrent GABAergic agonism and glutamatergic antagonism. Importantly, topiramate also impacts mood states central to many models of substance use. Despite this, little previous research has examined whether topiramate attenuates the respective associations of affect and craving with substance use.
OBJECTIVES


We conducted a secondary analysis of 63 youths that exhibited heavy cannabis use, aged 15-24 years, who were randomized in a double-blinded 6-week clinical trial comparing the effects of topiramate (up to 200 mg/day) and placebo on cannabis use. Ecological momentary assessment data were leveraged to model the role positive affect, negative affect, and craving on use over the 6-week period and whether topiramate attenuated associations between these feeling states and cannabis use.
RESULTS


Findings showed that craving was positively associated with use at the within-person level, while positive affect was negatively associated with use at the between-person level. Topiramate appears to attenuate the negative association of between-person positive affect (i.e., average) and cannabis use. Specifically, those in the placebo condition exhibited this inverse association between average positive affect and use while those in topiramate condition did not. No other significant affect or affect × medication condition interactions were observed.
CONCLUSIONS


These findings implicate craving and low positive affect as important risk factors for cannabis use in youth in treatment. Topiramate may attenuate this association for positive affect.",2021,No other significant affect or affect ,"['63 youths that exhibited heavy cannabis use, aged 15-24\xa0years']","['topiramate', 'Topiramate', 'placebo']",[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0380272,No other significant affect or affect ,"[{'ForeName': 'Noah N', 'Initials': 'NN', 'LastName': 'Emery', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Ryan W', 'Initials': 'RW', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychological Sciences, University of Missouri St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Samuel N', 'Initials': 'SN', 'LastName': 'Meisel', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Box S121-4, Providence, RI, 02912, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Miranda', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Box S121-4, Providence, RI, 02912, USA. Robert_Miranda_Jr@brown.edu.'}]",Psychopharmacology,['10.1007/s00213-021-05925-5']
663,34339059,How to improve clotting factors depletion in double-filtration plasmapheresis.,"BACKGROUND


Double-filtration plasmapheresis (DFPP), a selective therapeutic apheresis, can deplete pathogenic antibodies/substances, but also important coagulation factors.
AIM


To determine if the use of a separator filter with different characteristics (CascadefloEC-50 W) as compared to the reference filter (PlasmafloOP-08 W) is as efficient in terms of immunoglobulin loss, but can reduce coagulation factor losses and have similar tolerability.
PATIENTS/METHODS


This is a single-center prospective study including 14 patients divided into two groups (7 each): that is, group1 = CascadefloEC-50 W and group2 = PlasmafloOP-08 W. We measured immunoglobulins, lipid profiles, blood-cell counts, hemostasis (prothrombin time, activated partial thromboplastin time), coagulation factors, and natural anticoagulants at before and after the first DFPP-session.
RESULTS


In group 1, the loss of coagulation factors was significantly reduced as compared to group 2 for proteins with a molecular weight of >150 kDa: there was, respectively, an average decrease of 70% vs 31% for fibrinogen (P = 0.004), 66% vs 21% for factor V (P = 2.16e-07), 60% vs 32% for factor XI (P = 6.96e-06), 75% vs 17% for XIII-antigen (P = 0.0002), and 47% vs 0% for VWF-antigen(P = 0.02). The decrease in post-session IgG was, on average, 45% in group 1 and 50% in group 2 (P = 0.13). Those results remained significant even when adjusted to the treated-plasma volume and the pre-DFPP factor values.
CONCLUSION


DFPP, using a CascadefloEC-50W as a first-filter, reduces efficiently IgGs similarly to PlasmafloOP-08W but spares clotting factors.",2021,"The decrease in post-session IgG was, on average, 45% in group 1 and 50% in group 2 (P = 0.13).","['14 patients divided into two groups (7 each): that is, group1\xa0']","['Double-filtration plasmapheresis (DFPP', 'PlasmafloOP-08\u2009W', 'CascadefloEC-50\u2009W and group2\xa0', 'separator filter with different characteristics (CascadefloEC-50\u2009W']","['loss of coagulation factors', 'immunoglobulins, lipid profiles, blood-cell counts, hemostasis (prothrombin time, activated partial thromboplastin time), coagulation factors, and natural anticoagulants', 'clotting factors depletion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C5200809', 'cui_str': 'Double Filtration Plasmapheresis'}, {'cui': 'C0180860', 'cui_str': 'Filter'}]","[{'cui': 'C0005789', 'cui_str': 'Blood clotting factor'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}]",14.0,0.0176681,"The decrease in post-session IgG was, on average, 45% in group 1 and 50% in group 2 (P = 0.13).","[{'ForeName': 'Hamza', 'Initials': 'H', 'LastName': 'Naciri Bennani', 'Affiliation': 'Nephrology, Hemodialysis, Apheresis and Kidney Transplantation Department, Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Marlu', 'Affiliation': 'Hemostasis Laboratory, Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Terrec', 'Affiliation': 'Nephrology, Hemodialysis, Apheresis and Kidney Transplantation Department, Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Motte', 'Affiliation': 'Nephrology, Hemodialysis, Apheresis and Kidney Transplantation Department, Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Landry', 'Initials': 'L', 'LastName': 'Seyve', 'Affiliation': 'Hemostasis Laboratory, Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Eloi', 'Initials': 'E', 'LastName': 'Chevallier', 'Affiliation': 'Nephrology, Hemodialysis, Apheresis and Kidney Transplantation Department, Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Malvezzi', 'Affiliation': 'Nephrology, Hemodialysis, Apheresis and Kidney Transplantation Department, Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jouve', 'Affiliation': 'University Grenoble-Alpes, Grenoble, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Rostaing', 'Affiliation': 'Nephrology, Hemodialysis, Apheresis and Kidney Transplantation Department, Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Noble', 'Affiliation': 'Nephrology, Hemodialysis, Apheresis and Kidney Transplantation Department, Grenoble University Hospital, Grenoble, France.'}]",Journal of clinical apheresis,['10.1002/jca.21928']
664,34348351,Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial.,"IMPORTANCE


Polypoidal choroidal vasculopathy (PCV) is far less common and studied in a Caucasian population than in an Asian population, and the optimal treatment approach remains to be confirmed.
METHODS


A 52-week, double-masked, sham-controlled, phase 4, investigator-initiated randomized clinical trial (RCT) in naive symptomatic Caucasian patients with PCV treated with aflibercept in a treat-and-extend regimen (T&amp;E) (intravitreal aflibercept injection [IVAI] T&amp;E). Patients were randomized at week 16 to receive IVAI T&amp;E plus either sham photodynamic therapy (PDT) or standard fluence PDT with verteporfin. The main outcome measures were changes in best-corrected visual acuity (BCVA) from baseline to 52 weeks and polyp occlusion at week 52. Data are presented as median (interquartile range [IQR]) for BCVA, number of IVAI, and change in central retinal thickness (CRT).
RESULTS


Of the 50 patients included in the study, 48 patients completed the 52 weeks of follow-up. During this period, a significant median (IQR) BCVA gain of 6 [2-12] Early Treatment Diabetic Retinopathy Study letters was observed for all patients (p < 0.001), after 8 (7-9) injections, with a significant reduction of -93.0 [-154.0, -44.0] µm in central macular thickness (p < 0.001). Using indocyanine green angiography, a complete occlusion of polypoidal lesions was documented in 72% of the cases. Still, no significant difference was detected between the sham PDT and the aflibercept PDT arms, at week 52, for BCVA change (6.5 [2-11] vs. 5 [2-13] letters (p = 0.98)), number of IVAIs (8.5 [7-9] vs. 8 [7-9] (p = 0.21)), change in CRT (-143 [-184; -47] vs. -89 [-123; -41.5] µm [p = 0.23]), and rates of complete polyp occlusion: 77 versus 68% (p = 0.53) or presence of fluid: 68 versus 57% (p = 0.56). No serious ocular adverse events were registered in the 2 arms.
CONCLUSIONS AND RELEVANCE


To our knowledge, this is the first RCT to compare aflibercept T&amp;E monotherapy with aflibercept T&amp;E plus verteporfin PDT in a Caucasian population with PCV. Aflibercept monotherapy in a T&amp;E showed to be effective and safe with a significant median BCVA improvement of 6 letters and a complete occlusion of polypoidal lesions in near 3 quarters of the eyes, at 1 year. As only 22% of the eyes underwent PDT treatment, the benefit of combined treatment for PCV in Caucasian patients could not be definitively elucidated from this study.
TRIAL REGISTRATION


The clinical trial was registered in ClinicalTrials.gov Identifier NCT02495181 and the European Union Drug Regulating Authorities Clinical Trials Database EudraCT No. 2015-001368-20.",2022,,['Caucasian Population with Polypoidal Choroidal Vasculopathy'],['Intravitreal Aflibercept Vs Verteporfin Photodynamic Therapy'],['Efficacy and safety'],"[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1504336', 'cui_str': 'Polypoidal choroidal vasculopathy'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0387288', 'cui_str': 'Verteporfin'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.193785,,"[{'ForeName': 'Rufino', 'Initials': 'R', 'LastName': 'Silva', 'Affiliation': 'Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Arias', 'Affiliation': ""Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Sandrina', 'Initials': 'S', 'LastName': 'Nunes', 'Affiliation': 'Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Farinha', 'Affiliation': 'Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Coimbra', 'Affiliation': 'Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal.'}, {'ForeName': 'João P', 'Initials': 'JP', 'LastName': 'Marques', 'Affiliation': 'Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Cachulo', 'Affiliation': 'Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Figueira', 'Affiliation': 'Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Barreto', 'Affiliation': 'Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal.'}, {'ForeName': 'Maria H', 'Initials': 'MH', 'LastName': 'Madeira', 'Affiliation': 'Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Pires', 'Affiliation': 'Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal.'}, {'ForeName': 'João C', 'Initials': 'JC', 'LastName': 'Sousa', 'Affiliation': 'Centro Hospitalar de Leiria, Leiria, Portugal.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Distefano', 'Affiliation': ""Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Rosa', 'Affiliation': 'Instituto Retina Diabetes Ocular de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Ângela', 'Initials': 'Â', 'LastName': 'Carneiro', 'Affiliation': 'Department of Ophthalmology, Centro Hospitalar de São João, EPE, Oporto, Portugal.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vaz-Pereira', 'Affiliation': 'Department of Ophthalmology, Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria, Lisbon, Portugal.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Meireles', 'Affiliation': 'Centro Hospitalar Porto-Hospital Santo António, Oporto, Portugal.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cabrera', 'Affiliation': 'Hospital Insular de Gran Canaria (Las Palmas), Canarias, Spain.'}, {'ForeName': 'Anniken', 'Initials': 'A', 'LastName': 'Bures', 'Affiliation': 'Instituto Microcirugia Ocular, Barcelona, Spain.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Mendonça', 'Affiliation': 'Department of Ophthalmology, Hospital Braga, Braga, Portugal.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Fernandez-Vega-Sanz', 'Affiliation': 'Instituto Oftalmológico Fernandez-Veja, Oviedo, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Barrão', 'Affiliation': 'Instituto de Oftalmologia Dr. Gama Pinto, Lisbon, Portugal.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Koh', 'Affiliation': 'Eye & Retina Surgeons, Singapore, Singapore.'}, {'ForeName': 'Chui Ming Gemmy', 'Initials': 'CMG', 'LastName': 'Cheung', 'Affiliation': 'Singapore Eye Research Institute, Singapore, Singapore.'}, {'ForeName': 'José G', 'Initials': 'JG', 'LastName': 'Cunha-Vaz', 'Affiliation': 'Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Murta', 'Affiliation': 'Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde,['10.1159/000518235']
665,33333055,Lead-Time Trajectory of CA19-9 as an Anchor Marker for Pancreatic Cancer Early Detection.,"BACKGROUND & AIMS


There is substantial interest in liquid biopsy approaches for cancer early detection among subjects at risk, using multi-marker panels. CA19-9 is an established circulating biomarker for pancreatic cancer; however, its relevance for pancreatic cancer early detection or for monitoring subjects at risk has not been established.
METHODS


CA19-9 levels were assessed in blinded sera from 175 subjects collected up to 5 years before diagnosis of pancreatic cancer and from 875 matched controls from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. For comparison of performance, CA19-9 was assayed in blinded independent sets of samples collected at diagnosis from 129 subjects with resectable pancreatic cancer and 275 controls (100 healthy subjects; 50 with chronic pancreatitis; and 125 with noncancerous pancreatic cysts). The complementary value of 2 additional protein markers, TIMP1 and LRG1, was determined.
RESULTS


In the PLCO cohort, levels of CA19-9 increased exponentially starting at 2 years before diagnosis with sensitivities reaching 60% at 99% specificity within 0 to 6 months before diagnosis for all cases and 50% at 99% specificity for cases diagnosed with early-stage disease. Performance was comparable for distinguishing newly diagnosed cases with resectable pancreatic cancer from healthy controls (64% sensitivity at 99% specificity). Comparison of resectable pancreatic cancer cases to subjects with chronic pancreatitis yielded 46% sensitivity at 99% specificity and for subjects with noncancerous cysts, 30% sensitivity at 99% specificity. For prediagnostic cases below cutoff value for CA19-9, the combination with LRG1 and TIMP1 yielded an increment of 13.2% in sensitivity at 99% specificity (P = .031) in identifying cases diagnosed within 1 year of blood collection.
CONCLUSION


CA19-9 can serve as an anchor marker for pancreatic cancer early detection applications.",2021,Performance was comparable for distinguishing newly diagnosed cases with resectable pancreatic cancer from healthy controls (64% sensitivity at 99% specificity).,"['CA19-9 levels were assessed in blinded sera from 175 subjects collected up to 5 years before diagnosis of pancreatic cancer and from 875 matched controls from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial', '129 subjects with resectable pancreatic cancer and 275 controls (100 healthy subjects; 50 with chronic pancreatitis; and 125 with noncancerous pancreatic cysts']",[],['levels of CA19'],"[{'cui': 'C0201551', 'cui_str': 'Cancer antigen 19-9 measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C4517897', 'cui_str': '875'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0854778', 'cui_str': 'Pancreatic carcinoma resectable'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0149521', 'cui_str': 'Chronic pancreatitis'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030283', 'cui_str': 'Cyst of pancreas'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}]",875.0,0.0326872,Performance was comparable for distinguishing newly diagnosed cases with resectable pancreatic cancer from healthy controls (64% sensitivity at 99% specificity).,"[{'ForeName': 'Johannes F', 'Initials': 'JF', 'LastName': 'Fahrmann', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'C Max', 'Initials': 'CM', 'LastName': 'Schmidt', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Xiangying', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Irajizad', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Loftus', 'Affiliation': ""Dana-Farber Brigham and Women's Cancer Center, Division of Gastrointestinal Oncology, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Jinming', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Dana-Farber Brigham and Women's Cancer Center, Division of Gastrointestinal Oncology, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Nikul', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Vykoukal', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Dennison', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Long', 'Affiliation': 'Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Kim-Anh', 'Initials': 'KA', 'LastName': 'Do', 'Affiliation': 'Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Chabot', 'Affiliation': 'Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, Department of Epidemiology, Columbia Mailman School of Public Health, New York, New York.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Kluger', 'Affiliation': 'Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, Department of Epidemiology, Columbia Mailman School of Public Health, New York, New York.'}, {'ForeName': 'Fay', 'Initials': 'F', 'LastName': 'Kastrinos', 'Affiliation': 'Division of Digestive and Liver Diseases, Columbia University Irving Medical Cancer and the Vagelos College of Physicians and Surgeons, New York, New York, Department of Pathology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas; Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, Department of Surgery, New York, New York.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Brais', 'Affiliation': ""Dana-Farber Brigham and Women's Cancer Center, Division of Gastrointestinal Oncology, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Babic', 'Affiliation': ""Dana-Farber Brigham and Women's Cancer Center, Division of Gastrointestinal Oncology, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Jajoo', 'Affiliation': ""Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Lee', 'Affiliation': ""Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Clancy', 'Affiliation': ""Dana-Farber Brigham and Women's Cancer Center, Division of Surgical Oncology, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': ""Dana-Farber Brigham and Women's Cancer Center, Division of Gastrointestinal Oncology, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bullock', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Genkinger', 'Affiliation': 'Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, Department of Epidemiology, Columbia Mailman School of Public Health, New York, New York.'}, {'ForeName': 'Michele T', 'Initials': 'MT', 'LastName': 'Yip-Schneider', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Anirban', 'Initials': 'A', 'LastName': 'Maitra', 'Affiliation': 'Division of Digestive and Liver Diseases, Columbia University Irving Medical Cancer and the Vagelos College of Physicians and Surgeons, New York, New York, Department of Pathology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Wolpin', 'Affiliation': ""Dana-Farber Brigham and Women's Cancer Center, Division of Gastrointestinal Oncology, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Hanash', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas M. D. Anderson Cancer Center, Houston, Texas. Electronic address: shanash@mdanderson.org.'}]",Gastroenterology,['10.1053/j.gastro.2020.11.052']
666,34321410,Comparison of refractive and visual outcomes of 3 presbyopia-correcting intraocular lenses.,"PURPOSE


To evaluate and compare the clinical outcomes after cataract surgery with implantation of 3 types of trifocal diffractive intraocular lenses (IOLs).
SETTING


Hospital da Luz, Lisbon, Portugal.
DESIGN


Prospective comparative case series.
METHODS


Patients undergoing phacoemulsification cataract surgery with implantation of 1 of the 3 trifocal IOLs were enrolled: TECNIS Synergy (Synergy group, 30 patients), Acrysof PanOptix (PanOptix group, 30 patients), and POD F (Finevision group, 30 patients). The outcomes of distance, intermediate, and near visual acuity (VA), refraction, defocus curve, photic phenomena, and spectacle independence were evaluated at the 3-month follow-up.
RESULTS


180 eyes of 90 patients were enrolled. No statistically significant differences were found between groups in monocular distance-corrected intermediate (Synergy group 0.04 ± 0.11, PanOptix group 0.05 ± 0.09, and Finevision group 0.08 ± 0.10; P = .107) and near VA (0.01 ± 0.08, 0.01 ± 0.06, and 0.04 ± 0.10, respectively; P = .186). Similarly, no statistically significant differences among groups were found in binocular uncorrected distance (P = .572), near (P = .929), and intermediate VA (P = .327). By contrast, statistically significant differences between groups were found in the visual acuity for the vergence demands of -0.50, -1.00, -2.00, -3.50, and -4.00 diopters (P ≤ .045). No statistically significant differences among groups were found in the frequency, severity, and bothersomeness of different disturbing visual symptoms, including glare and halos (P ≥ .129). More than 87 (96%) of patients in all groups did not require the use of spectacles at any distance postoperatively.
CONCLUSIONS


The 3 trifocal IOLs evaluated provided an effective visual rehabilitation with minimal incidence of photic phenomena. A trend to obtain a wider range of functional focus was observed with the TECNIS Synergy IOL.",2022,"No significant differences among groups were found either in the frequency, severity and bothersomeness of different disturbing visual symptoms, including glare and haloes (p≥0.129).","['180 eyes of 90 patients undergoing phacoemulsification cataract surgery with implantation of one of these trifocal IOLs were enrolled', 'Hospital da Luz, Lisbon, Portugal', 'Synergy group, 30 patients), Acrysof PanOptix (Alcon) (PanOptix group, 30 patients), and POD F (PhysIOL) (Finevision group, 30 patients']","['trifocal diffractive intraocular lenses (IOLs', 'Tecnis Synergy (J&J Vision']","['monocular distance-corrected intermediate', 'binocular uncorrected distance', 'distance, intermediate and near visual acuity (VA), refraction, defocus curve, photic phenomena and spectacle independence', 'frequency, severity and bothersomeness of different disturbing visual symptoms, including glare and haloes', 'visual acuity']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0422943', 'cui_str': 'Visual symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0278215', 'cui_str': 'Glare'}, {'cui': 'C0181278', 'cui_str': 'Halo brace'}]",90.0,0.0397405,"No significant differences among groups were found either in the frequency, severity and bothersomeness of different disturbing visual symptoms, including glare and haloes (p≥0.129).","[{'ForeName': 'Tiago B', 'Initials': 'TB', 'LastName': 'Ferreira', 'Affiliation': 'From the Hospital da Luz Lisboa, Lisbon, Portugal (Ferreira, Ribeiro, Silva, Matos, Gaspar, Almeida); Lisbon University, Lisbon, Portugal (Ribeiro); Visual Sciences Research Centre, Lisbon, Portugal (Ribeiro).'}, {'ForeName': 'Filomena J', 'Initials': 'FJ', 'LastName': 'Ribeiro', 'Affiliation': ''}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Ana Cláudia', 'Initials': 'AC', 'LastName': 'Matos', 'Affiliation': ''}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Gaspar', 'Affiliation': ''}, {'ForeName': 'Soraia', 'Initials': 'S', 'LastName': 'Almeida', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000743']
667,34325772,Effects of Tinidazole on Food Intake in Chinchillas ( Chinchilla lanigera ).,"Tinidazole is a second-generation nitroimidazole compound that is used as an antimicrobial to treat anaerobic bacterial and protozoal infections in humans and, less frequently, in veterinary medicine. However, metronidazole, another secondgeneration nitroimidazole, is more commonly used. Nonetheless, tinidazole has proven to be a superior therapy for parasitic infections in humans, particularly in the treatment of giardiasis. Furthermore, in chinchillas, metronidazole has been shown to cause a clinically relevant reduction in food intake after oral administration at published dosages. This study's objective was to evaluate the effect of orally administered tinidazole on food intake in healthy chinchillas. In 2 randomized, placebocontrolled, blinded, crossover studies, tinidazole was evaluated at 2 single high doses (100 mg/kg and 200 mg/kg PO,  n  = 9) and a repeated dosing schedule at a lower dose (20 mg/kg PO q12h for 10 doses,  n  = 12). Food intake was measured over 24-h periods before and after drug administration. The single-dose treatment groups both displayed significantly reduced food intake (200 mg/kg: -26 ± 21%; 100 mg/kg: -9 ± 21%,  P  < 0.01) as compared with the control group during the first 24 h after drug administration. Food intake returned to pretreatment values within 4-5 d. Repeated administration at 20 mg/kg q12h was not associated with any significant changes in food intake. No other adverse effects were noted during this study. Tinidazole administration at single higher doses resulted in an acute self-limiting reduction in food intake. In comparison, repeated administration of lower doses (20 mg/kg PO q12h) had no significant effects on food intake in healthy chinchillas. Therefore, tinidazole may be a more suitable drug for treating  Giardia  and anaerobic bacterial infections in this species than the more commonly used metronidazole.",2021,"The single-dose treatment groups both displayed significantly reducedfood intake (200 mg/kg: -26 ± 21%; 100 mg/kg: -9 ± 21%, P < 0.01) as compared with the control group during the first 24 hafter drug administration.","['healthy chinchillas', 'Chinchillas (Chinchilla lanigera']","['placebocontrolled', 'Tinidazole', 'tinidazole', 'metronidazole']","['Food intake', 'Food Intake', 'adverse effects', 'food intake', 'reducedfood intake']","[{'cui': 'C0008119', 'cui_str': 'Genus Chinchilla'}]","[{'cui': 'C0040263', 'cui_str': 'Tinidazole'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",,0.0537244,"The single-dose treatment groups both displayed significantly reducedfood intake (200 mg/kg: -26 ± 21%; 100 mg/kg: -9 ± 21%, P < 0.01) as compared with the control group during the first 24 hafter drug administration.","[{'ForeName': 'Chelsey M', 'Initials': 'CM', 'LastName': 'Tournade', 'Affiliation': 'University of Wisconsin-Madison, School of Veterinary Medicine, Madison, Wisconsin.'}, {'ForeName': 'Dustin M', 'Initials': 'DM', 'LastName': 'Fink', 'Affiliation': 'University of Wisconsin-Madison, School of Veterinary Medicine, Madison, Wisconsin.'}, {'ForeName': 'Shelby R', 'Initials': 'SR', 'LastName': 'Williams', 'Affiliation': 'University of Wisconsin-Madison, School of Veterinary Medicine, Madison, Wisconsin.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Mans', 'Affiliation': 'University of Wisconsin-Madison, School of Veterinary Medicine, Madison, Wisconsin;, Email: christoph.mans@wisc.edu.'}]",Journal of the American Association for Laboratory Animal Science : JAALAS,['10.30802/AALAS-JAALAS-20-000141']
668,34331403,Effects of the Mediterranean Diet or Nut Consumption on Gut Microbiota Composition and Fecal Metabolites and their Relationship with Cardiometabolic Risk Factors.,"SCOPE


To examine whether a Mediterranean Diet (MedDiet) compared to the consumption of nuts in the context of a habitual non-MedDiet exerts a greater beneficial effect on gut microbiota and fecal metabolites; thus, contributing to explain major benefits on cardiometabolic risk factors.
METHODS AND RESULTS


Fifty adults with Metabolic Syndrome are randomized to a controlled, crossover 2-months dietary-intervention trial with a 1-month wash-out period, following a MedDiet or consuming nuts (50 g day -1  ). Microbiota composition is assessed by 16S rRNA gene sequencing and metabolites are measured using Nuclear Magnetic Resonance (NMR) and liquid chromatography coupled to triple quadrupole mass spectrometry (LC-qTOF) platforms in a targeted metabolomics approach. Decreased glucose, insulin and the homeostatic model assessment of insulin resistance (HOMA-IR) is observed after the MedDiet compared to the nuts intervention. Relative abundances of Lachnospiraceae NK4A136 and an uncultured genera of Ruminococcaceae are significantly increased after the MedDiet compared to nuts supplementation. Changes in Lachnospiraceae NK4A136 are inversely associated with insulin levels and HOMA-IR, while positively and negatively with changes in cholate and cadaverine, respectively.
CONCLUSIONS


Following a MedDiet, rather than nuts, induces a significant increase in Lachnospiraceae NK4A136 and improves the metabolic risk. This genera seems to affect the bile acid metabolism and cadaverine which may account for the improvement in insulin levels.",2021,"Changes in Lachnospiraceae NK4A136 were inversely associated with insulin levels and HOMA-IR, while positively and negatively with changes in cholate and cadaverine, respectively.
",['Fifty adults with Metabolic Syndrome'],"['Mediterranean Diet (MedDiet', 'MedDiet or consuming nuts', 'Mediterranean Diet or Nut Consumption']","['Relative abundances of Lachnospiraceae NK4A136\xa0and un uncultured genera of Ruminococcaceae', 'Lachnospiraceae NK4A136', 'metabolic risk', 'Microbiota composition', 'Decreased glucose, insulin and HOMA-IR', 'insulin levels and HOMA-IR', 'Gut Microbiota Composition and Fecal Metabolites']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1210564', 'cui_str': 'Lachnospiraceae'}, {'cui': 'C2584567', 'cui_str': 'Ruminococcaceae'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",50.0,0.0383033,"Changes in Lachnospiraceae NK4A136 were inversely associated with insulin levels and HOMA-IR, while positively and negatively with changes in cholate and cadaverine, respectively.
","[{'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Galié', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'García-Gavilán', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Camacho-Barcía', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Atzeni', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}, {'ForeName': 'Jananee', 'Initials': 'J', 'LastName': 'Muralidharan', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Papandreou', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Arcelin', 'Affiliation': 'IISPV, Institute of Health Pere Virgily, Reus, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Palau-Galindo', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garcia', 'Affiliation': ""ABS Alt Camp Oest. Centre d'Atenció Primària Alcover, Spain.""}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Basora', 'Affiliation': 'Tarragona-Reus Research Support Unit, Jordi Gol University Institute for Primary Care Research, Tarragona, 43202, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Arias-Vasquez', 'Affiliation': 'Department of Psychiatry, Radboudumc, Cognition and Behaviour, Donders Institute for Brain, Nijmegen, GA, 6525, The Netherlands.'}, {'ForeName': 'Mònica', 'Initials': 'M', 'LastName': 'Bulló', 'Affiliation': 'Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, University RoviraiVirgili (URV), Reus, Spain.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000982']
669,34337893,Blood glucose concentration is unchanged during exposure to acute normobaric hypoxia in healthy humans.,"Normal blood [glucose] regulation is critical to support metabolism, particularly in contexts of metabolic stressors (e.g., exercise, high altitude hypoxia). Data regarding blood [glucose] regulation in hypoxia are inconclusive. We aimed to characterize blood [glucose] over 80 min following glucose ingestion during both normoxia and acute normobaric hypoxia. In a randomized cross-over design, on two separate days, 28 healthy participants (16 females; 21.8 ± 1.6 years; BMI 22.8 ± 2.5 kg/m 2  ) were randomly exposed to either NX (room air; fraction of inspired [F I  ]O 2  ~0.21) or HX (F I  O 2  ~0.148) in a normobaric hypoxia chamber. Measured F I  O 2  and peripheral oxygen saturation were both lower at baseline in hypoxia (p < 0.001), which was maintained over 80 min, confirming the hypoxic intervention. Following a 10-min baseline (BL) under both conditions, participants consumed a standardized glucose beverage (75 g, 296 ml) and blood [glucose] and physiological variables were measured at BL intermittently over 80 min. Blood [glucose] was measured from finger capillary samples via glucometer. Initial fasted blood [glucose] was not different between trials (NX:4.8 ± 0.4 vs. HX:4.9 ± 0.4 mmol/L; p = 0.47). Blood [glucose] was sampled every 10 min (absolute, delta, and percent change) following glucose ingestion over 80 min, and was not different between conditions (p > 0.77). In addition, mean, peak, and time-to-peak responses during the 80 min were not different between conditions (p > 0.14). There were also no sex differences in these blood [glucose] responses in hypoxia. We conclude that glucose regulation is unchanged in young, healthy participants with exposure to acute steady-state normobaric hypoxia, likely due to counterbalancing mechanisms underlying blood [glucose] regulation in hypoxia.",2021,"Measured F I  O 2  and peripheral oxygen saturation were both lower at baseline in hypoxia (p < 0.001), which was maintained over 80 min, confirming the hypoxic intervention.","['healthy humans', 'young, healthy participants with exposure to acute steady-state normobaric hypoxia', '28\xa0healthy participants (16 females; 21.8\xa0±\xa01.6\xa0years; BMI 22.8\xa0±\xa02.5\xa0kg/m 2  ']","['NX (room air; fraction of inspired [F I  ]O 2  ~0.21) or HX (F I  O 2  ~0.148) in a normobaric hypoxia chamber', 'standardized glucose beverage']","['Measured F I  O 2  and peripheral oxygen saturation', 'Initial fasted blood [glucose', 'mean, peak, and time-to-peak responses', 'blood [glucose] responses', 'Blood [glucose', 'Blood glucose concentration']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}]",,0.035154,"Measured F I  O 2  and peripheral oxygen saturation were both lower at baseline in hypoxia (p < 0.001), which was maintained over 80 min, confirming the hypoxic intervention.","[{'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Chan', 'Affiliation': 'Department of Biology, Faculty of Science and Technology, Mount Royal University, Calgary, AB, Canada.'}, {'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Chiew', 'Affiliation': 'Department of Biology, Faculty of Science and Technology, Mount Royal University, Calgary, AB, Canada.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Rimke', 'Affiliation': 'Department of Biology, Faculty of Science and Technology, Mount Royal University, Calgary, AB, Canada.'}, {'ForeName': 'Garrick', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Department of Biology, Faculty of Science and Technology, Mount Royal University, Calgary, AB, Canada.'}, {'ForeName': 'Zahrah H', 'Initials': 'ZH', 'LastName': 'Rampuri', 'Affiliation': 'Department of Biology, Faculty of Science and Technology, Mount Royal University, Calgary, AB, Canada.'}, {'ForeName': 'Mackenzie D', 'Initials': 'MD', 'LastName': 'Kozak', 'Affiliation': 'Department of Biology, Faculty of Science and Technology, Mount Royal University, Calgary, AB, Canada.'}, {'ForeName': 'Normand G', 'Initials': 'NG', 'LastName': 'Boulé', 'Affiliation': 'Alberta Diabetes Institute, Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Craig D', 'Initials': 'CD', 'LastName': 'Steinback', 'Affiliation': 'Alberta Diabetes Institute, Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Margie H', 'Initials': 'MH', 'LastName': 'Davenport', 'Affiliation': 'Alberta Diabetes Institute, Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Day', 'Affiliation': 'Department of Biology, Faculty of Science and Technology, Mount Royal University, Calgary, AB, Canada.'}]",Physiological reports,['10.14814/phy2.14932']
670,34351533,"Economic evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: a cost-utility and cost-consequences analysis.","BACKGROUND


People in prison experience a range of physical and mental health problems. Evaluating the effectiveness and efficiency of prison-based interventions presents a number of methodological challenges. We present a case study of an economic evaluation of a prison-based intervention (""Engager"") to address common mental health problems.
METHODS


Two hundred and eighty people were recruited from prisons in England and randomised to Engager plus usual care or usual care. Participants were followed up for 12 months following release from prison. The primary analysis is the cost per quality-adjusted life year (QALY) gained of Engager compared to usual care from a National Health Service (NHS) perspective with QALYs calculated using the CORE 6 Dimension. A cost-consequences analysis evaluated cross-sectoral costs and a range of outcomes.
RESULTS


From an NHS perspective, Engager cost an additional £2737 per participant (95% of iterations between £1029 and £4718) with a mean QALY difference of - 0.014 (95% of iterations between - 0.045 and 0.017). For the cost-consequences, there was evidence of improved access to substance misuse services 12 months post-release (odds ratio 2.244, 95% confidence Interval 1.304-3.861).
CONCLUSION


Engager provides a rare example of a cost-utility analysis conducted in prisons and the community using patient-completed measures. Although the results from this trial show no evidence that Engager is cost-effective, the results of the cost-consequences analysis suggest that follow-up beyond 12 months post-release using routine data may provide additional insights into the effectiveness of the intervention and the importance of including a wide range of costs and outcomes in prison-based economic evaluations.
TRIAL REGISTRATION


(ISRCTN11707331).",2022,"For the cost-consequences, there was evidence of improved access to substance misuse services 12 months post-release (odds ratio 2.244, 95% confidence Interval 1.304-3.861).
","['prisoners with common mental health problems', 'People in prison experience a range of physical and mental health problems', 'Two hundred and eighty people were recruited from prisons in England and randomised to']","['complex intervention (Engager', 'Engager plus usual care or usual care', 'prison-based intervention (""Engager']",['cost per quality-adjusted life year (QALY) gained of Engager compared to usual care from a National Health Service (NHS) perspective with QALYs'],"[{'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}]",280.0,0.0578626,"For the cost-consequences, there was evidence of improved access to substance misuse services 12 months post-release (odds ratio 2.244, 95% confidence Interval 1.304-3.861).
","[{'ForeName': 'Rachael Maree', 'Initials': 'RM', 'LastName': 'Hunter', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London (UCL), Rowland Hill Street, London, NW3 2PF, UK. r.hunter@ucl.ac.uk.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'Primary Care Department, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Kirkpatrick', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lennox', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Warren', 'Affiliation': 'Primary Care Department, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'Primary Care Department, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Haddad', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Stirzaker', 'Affiliation': 'NHS England, South West Mental Health Clinical Network, Taunton, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Maguire', 'Affiliation': 'Centre for Criminology, University of South Wales, Pontypridd, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Byng', 'Affiliation': 'Community and Primary Care Research Group, University of Plymouth, Plymouth, UK.'}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-021-01360-7']
671,34363278,Consequences of child maltreatment: A glimpse at stress and sleep.,"The present study goal was to provide further information on the association of maltreatment experiences in childhood (CM) and impaired sleep taking the hyperarousal theory of insomnia and stress reaction into account. In all, 62 participants took part in the study. CM history (Childhood Trauma Questionnaire) and subjective sleep quality (Pittsburgh Sleep Quality Index) were assessed before study commencement. In addition, participants wore an actigraph for 6-7 consecutive nights and completed a sleep log during this time. After 3-4 days, the participants took part in a laboratory stress paradigm (Maastricht Acute Stress Test) with 29 participants in the experimental and 31 in the control condition. Saliva cortisol samples were taken before and after the experiment and heart rate variability was assessed. CM was positively correlated with impaired subjectively assessed sleep in adulthood. The stress manipulation led to heightened subjective and physiological stress. Although lower cortisol changes after and lower mean heart rate values during the stress induction were found in the CM group, the differences were not statistically significant. There was no observable sleep reactivity on the stress induction. Stress and CM appear to have long-term effects on subjective sleep. Acute social stress does not directly worsen sleep quality, neither in participants with nor without a history of CM. However, the association underlines the importance of prevention and intervention. When treating sleep impairments, potential CM experiences should be taken into account.",2022,"Although lower cortisol changes after and lower mean heart rate values during the stress induction were found in the CM group, the differences were not statistically significant.","['child maltreatment', 'participants with nor without a history of CM', '62 participants took part in the study']",[],"['heart rate variability', 'CM history (Childhood Trauma Questionnaire) and subjective sleep quality (Pittsburgh Sleep Quality Index', 'CM', 'Saliva cortisol samples', 'subjective sleep', 'mean heart rate values']","[{'cui': 'C0008060', 'cui_str': 'Child abuse'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",62.0,0.0399746,"Although lower cortisol changes after and lower mean heart rate values during the stress induction were found in the CM group, the differences were not statistically significant.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Pfaff', 'Affiliation': 'Fakultät für Psychologie und Sportwissenschaft, Universität Bielefeld, Bielefeld, Germany.'}, {'ForeName': 'Angelika A', 'Initials': 'AA', 'LastName': 'Schlarb', 'Affiliation': 'Fakultät für Psychologie und Sportwissenschaft, Universität Bielefeld, Bielefeld, Germany.'}]",Journal of sleep research,['10.1111/jsr.13456']
672,34371511,Comparison of two phacoemulsification system handpieces: prospective randomized comparative study.,"PURPOSE


To compare the safety and efficacy of Active Sentry handpiece with Ozil handpiece for Centurion phacoemulsification system.
SETTING


Tertiary eye center, South India.
DESIGN


Prospective observational study.
METHODS


204 eyes of 204 patients with uncomplicated cataract who underwent phacoemulsification cataract surgery with Centurion Vision System were randomized into 2 groups: Ozil handpiece (n = 101) and Active Sentry handpiece (n = 103). Intraoperative factors such as patient pain perception, surgeon comfort level, amount of phacoemulsification energy and aspiration fluid used, and frequency of activation of active surge mitigation (ASM) were analyzed, and postoperatively, corrected distance visual acuity (CDVA) and corneal edema on day 1 were compared.
RESULTS


A total of 204 eyes of 204 patients were included among which 101 underwent surgery with ozil hand piece and 103 with Active Sentry handpiece. Patient pain perception was comparable between the groups with no statistically significant differences in patients who had pain-free surgery (66% vs 61.3%) and those who experienced moderate pain (24.3% vs 28.7%). Surgeons were more comfortable using Ozil handpiece during entry into anterior chamber and emulsification of hard nuclei (48.5% vs 28.6%). The mean cumulative dissipated energy for soft and hard cataracts was 5.6 and 4.8 and 9.3 and 9.4 for Ozil and Active Sentry groups, respectively. ASM was activated for 53 eyes (51.5%), of which 42 eyes (79.2%) had soft cataract and 11 eyes (20.7%) hard cataract. Postoperative CDVA and incidence of corneal edema were comparable between the groups.
CONCLUSIONS


For Centurion Vision System, Active Sentry handpiece was as safe and efficacious as the Ozil handpiece with added benefit of operating at lower intraocular pressure levels.",2022,"RESULTS


Patient's pain perception was comparable between the groups with no significant differences in proportion of patients who had pain free surgery (66% vs 61.3%) or those experienced moderate pain (24.3% vs 28.7%).","['204 eyes of 204 patients with uncomplicated cataract who underwent phacoemulsification cataract surgery with centurion vision system', 'Tertiary eye centre, South India']","['active sentry hand piece with ozil hand piece', 'Ozil hand piece (n=101) and active sentry hand piece']","['pain free surgery', 'distance visual acuity (CDVA) and corneal edema', 'safety and efficacy', 'mean CDE for soft cataracts', 'soft cataract', 'pain perception', ""Intra-operative factors like patient's pain perception, surgeon's comfort level, amount of phacoemulsification energy and aspiration fluid used, frequency of activation of active surge mitigation (ASM"", 'moderate pain', 'corneal edema', 'ASM']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0010037', 'cui_str': 'Corneal edema'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0108844', 'cui_str': 'CDE protocol'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0449896', 'cui_str': 'Fluid used'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}]",204.0,0.0490406,"RESULTS


Patient's pain perception was comparable between the groups with no significant differences in proportion of patients who had pain free surgery (66% vs 61.3%) or those experienced moderate pain (24.3% vs 28.7%).","[{'ForeName': 'Dhanya', 'Initials': 'D', 'LastName': 'Cyril', 'Affiliation': 'Department of Intraocular Lens and Cataract Services, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Madurai, India (Cyril, Brahmani, Prasad, Rashme, Sankarananthan R, Kamble, Nagu, Shekhar), and the Department of Biostatistics, Aravind Eye Care System, Madurai, India (Balakrishnan).'}, {'ForeName': 'Pathakamuri', 'Initials': 'P', 'LastName': 'Brahmani', 'Affiliation': ''}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Prasad', 'Affiliation': ''}, {'ForeName': 'Vinitha L', 'Initials': 'VL', 'LastName': 'Rashme', 'Affiliation': ''}, {'ForeName': 'Sankarananthan', 'Initials': 'S', 'LastName': 'R', 'Affiliation': ''}, {'ForeName': 'Nikhil Rajendra', 'Initials': 'NR', 'LastName': 'Kamble', 'Affiliation': ''}, {'ForeName': 'Logesh', 'Initials': 'L', 'LastName': 'Balakrishnan', 'Affiliation': ''}, {'ForeName': 'Kamatchi', 'Initials': 'K', 'LastName': 'Nagu', 'Affiliation': ''}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Shekhar', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000769']
673,34375677,Efficacy evaluation of PCSK9 monoclonal antibody (Evolocumab) in combination with Rosuvastatin and Ezetimibe on cholesterol levels in patients with coronary heart disease (CHD): A retrospective analysis from a single center in China.,"BACKGROUND AND PURPOSE


Proprotein convertase subtilisin-kexin type 9(PCSK9) monoclonal antibody (Mab; Evolocumab) has been reported to inhibit low-density lipoprotein cholesterol (LDL-C) and Lipoprotein(a) [LP(a)] in coronary heart diseases (CHD) patients in America, Europe and Japan. However, little is known about the effect of Evolocumab in Chinese population. This retrospective study in Chinese CHD patients compared the efficacy without or with Evolocumab therapy added to the conventional treatment with a statin (Rosuvastatin) and a gut cholesterol absorption inhibitor (Ezetimibe).
METHODS


CHD patients from our hospital were divided into three therapeutic groups, A) the statin monotherapy group (10 mg Rosuvastatin every night); B) the statin/cholesterol absorption inhibitor group (10 mg Rosuvastatin and 10 mg Ezetimibe daily); and C) the triple therapy with PCSK9 Mab group (10 mg Rosuvastatin daily, 10 mg Ezetimibe daily, and 140 mg Evolocumab once 2 weeks). The plasma lipid data were collected at 0, 4, 12, and 24 Week(s). The Graphpad Prism 7 program was used to perform all the statistical analysis.
RESULTS


Out of 103 patients 91 were eligible for further evaluation with 31 in group A, 31 in group B, and 29 in group C. The plasma LDL-C levels were reduced only by 33.82% in the Rosuvastatin monotherapy group, 52.13% in the Rosuvastatin/Ezetimibe group, and 73.59% in the Evolocumab/Rosuvastatin/Ezetimibe group (P < 0.0001) at 24 weeks compared to the prior therapy levels. Neither the statin therapy alone (5.95%; P = 0.6), nor the double therapy (5.27%; P = 0.7) affected LP(a) levels. In contrast, addition of Evolocumab to the double therapy significantly decreased LP(a) level by 37.2% (P < 0.0001).
CONCLUSION


Addition of Evolocumab to the standard double therapy in Chinese CHD patients improved the efficacy in LDL-C reduction when compared to Rosuvastatin alone or in Rosuvastatin/Ezetimibe double therapy. Furthermore, the addition of Evolocumab lowered LP(a) level in Chinese CHD patients.",2021,"The plasma LDL-C levels were reduced only by 33.82% in the Rosuvastatin monotherapy group, 52.13% in the Rosuvastatin/Ezetimibe group, and 73.59% in the Evolocumab/Rosuvastatin/Ezetimibe group (P < 0.0001) at 24 weeks compared to the prior therapy levels.","['Chinese CHD patients', 'coronary heart diseases (CHD) patients in America, Europe and Japan', 'single center in China', 'CHD patients from our hospital', 'patients with coronary heart disease (CHD', '103 patients 91 were eligible for further evaluation with 31 in group A, 31 in group B, and 29 in group C']","['statin/cholesterol absorption inhibitor group (10\u202fmg Rosuvastatin and 10\u202fmg Ezetimibe', 'PCSK9 Mab group (10\u202fmg Rosuvastatin daily, 10\u202fmg Ezetimibe', 'monoclonal antibody (Mab; Evolocumab', 'Evolocumab/Rosuvastatin/Ezetimibe', 'Rosuvastatin and Ezetimibe', 'Evolocumab therapy added to the conventional treatment with a statin (Rosuvastatin) and a gut cholesterol absorption inhibitor (Ezetimibe', 'Rosuvastatin', 'Evolocumab', 'Rosuvastatin/Ezetimibe', 'PCSK9 monoclonal antibody (Evolocumab', 'statin monotherapy']","['plasma lipid data', 'LP(a) level', 'efficacy in LDL-C reduction', 'LP(a) levels', 'plasma LDL-C levels', 'cholesterol levels']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1426592', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 gene'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C3700394', 'cui_str': 'rosuvastatin and ezetimibe'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}]","[{'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",,0.0607838,"The plasma LDL-C levels were reduced only by 33.82% in the Rosuvastatin monotherapy group, 52.13% in the Rosuvastatin/Ezetimibe group, and 73.59% in the Evolocumab/Rosuvastatin/Ezetimibe group (P < 0.0001) at 24 weeks compared to the prior therapy levels.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'MM, Cardiac Diagnosis and Treatment Center, Xuzhou Central Hospital, Xuzhou City, Jiangsu Province, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'MM, Cardiac Diagnosis and Treatment Center, Xuzhou Central Hospital, Xuzhou City, Jiangsu Province, China. Electronic address: dw566855@126.com.'}]",Transplant immunology,['10.1016/j.trim.2021.101444']
674,34327833,The glaucoma intensive treatment study: interim results from an ongoing longitudinal randomized clinical trial.,"PURPOSE


The aim of the study was to determine the perimetric rate of glaucoma progression in the ongoing Glaucoma Intensive Treatment Study (GITS) after 3 years of follow-up.
DESIGN


This is a randomized, two-centre, prospective open-labelled treatment trial for open-angle glaucoma (OAG).
PARTICIPANTS


The participants of this study were treatment-naive patients with newly diagnosed OAG, aged 46-78 years, with early to moderate glaucomatous visual field loss scheduled to be followed for 5 years within the study.
METHODS


Patients were randomized to initial treatment with either topical monotherapy or with an intensive approach using drugs from three different classes, plus 360° laser trabeculoplasty. Changes in treatment were allowed. Standard automated perimetry and tonometry were performed and side-effects documented. All results are presented using intention-to-treat analysis.
RESULTS


A total of 242 patients were randomized. After 3 years of follow-up, eight patients were lost to follow-up, six of whom were deceased. The median untreated baseline intraocular pressure (IOP) was 24 mmHg in both arms. The median IOP was almost constant over the 3 years of follow-up: ≈17 mmHg in the mono-arm and ≈14 mmHg in the multi-treatment arm. Treatment was intensified in 42% of the mono-treated patients and in 7% of the multi-treated patients. Treatment was reduced in 13% of the multi-treated patients. The median perimetric rate of progression was -0.5%/year in the mono-treated group and -0.1%/year in the multi-treated group (p = 0.03).
CONCLUSION


The rate of disease progression was significantly slower in the multi-treated patients than in the mono-treated patients. Further follow-up will show whether this difference is sustained over time.",2022,The median IOP was almost constant over the 3 years of follow-up: ≈17 mmHg in the mono-arm and ≈14 mmHg in the multi-treatment arm.,"['Patients', '242 patients were randomized', 'open-angle glaucoma (OAG', 'The participants of this study were treatment-naive patients with newly diagnosed OAG, aged 46-78\xa0years, with early to moderate glaucomatous visual field loss scheduled to be followed for 5\xa0years within the study']","['topical\xa0monotherapy or with an intensive approach using drugs from three different classes, plus 360° laser trabeculoplasty']","['rate of disease progression', 'median untreated baseline intraocular pressure (IOP', 'median perimetric rate of progression', 'median IOP', 'perimetric rate of glaucoma progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3887875', 'cui_str': 'Visual field defect'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0395482', 'cui_str': 'Laser trabeculoplasty'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}]",242.0,0.0762361,The median IOP was almost constant over the 3 years of follow-up: ≈17 mmHg in the mono-arm and ≈14 mmHg in the multi-treatment arm.,"[{'ForeName': 'Boel', 'Initials': 'B', 'LastName': 'Bengtsson', 'Affiliation': 'Department of Clinical Scien,ces in Malmö, Ophthalmology, Lund University, Lund, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lindén', 'Affiliation': 'Department of Clinical Sciences, Ophthalmology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Heijl', 'Affiliation': 'Department of Clinical Scien,ces in Malmö, Ophthalmology, Lund University, Lund, Sweden.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Andersson-Geimer', 'Affiliation': 'Department of Clinical Scien,ces in Malmö, Ophthalmology, Lund University, Lund, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Aspberg', 'Affiliation': 'Department of Clinical Scien,ces in Malmö, Ophthalmology, Lund University, Lund, Sweden.'}, {'ForeName': 'Gauti', 'Initials': 'G', 'LastName': 'Jóhannesson', 'Affiliation': 'Department of Clinical Sciences, Ophthalmology, Umeå University, Umeå, Sweden.'}]",Acta ophthalmologica,['10.1111/aos.14978']
675,34337917,Perioperative sedation requirements of infants aged 0 to 3 months subjected to lower-body surgery under caudal blockade: a randomized controlled trial.,"BACKGROUND


It remains unclear how much sedation is required for subumbilical surgery under caudal blockade, and sedatives may carry a poorly understood risk of late sequelae in infants. We designed a randomized controlled study to evaluate total propofol consumption and perioperative sedation quality with the avoidance of continuous perioperative sedation in infants undergoing surgery under caudal anesthesia.
METHODS


Thirty-two infants (age: 0-3 months) were randomized to one of two groups in which perioperative administration of propofol was provided either ""as needed"" or by continuous infusion (5 mg kg -1  h -1 ). After induction of anesthesia via a facemask with sevoflurane, a venous access was established and 1 mL kg -1  of ropivacaine 0.35% was injected for caudal anesthesia. Intraoperative stress was assessed by repeated recording comfort behavioral scale scores and heart rates.
RESULTS


Significantly (P=0.0001) less propofol was administered in the as-needed group (0.7±1.4 mg/kg) than in the continuous-infusion group (3.0±1.6 mg/kg). This difference was not reflected in different requirements of additional intraoperative sedation (0.5±0.8 mg/kg in 5 versus 0.6±1.0 mg/kg in four cases; P=0.76).
CONCLUSIONS


As needed propofol administration offers no disadvantage in terms of intraoperative sedation, but significant dose reductions can be achieved by avoiding continuous propofol infusion.",2022,Significantly (p = 0.0001) less propofol was administered in the as-needed group (0.7 ± 1.4 mg/kg) than in the continuous-infusion group (3.0 ± 1.6 mg/kg).,"['Thirty-two infants (age: 0-3 months', 'infants undergoing surgery under caudal anesthesia', 'infants aged 0 to 3 months subjected to lower-body surgery under caudal blockade']","['ropivacaine', 'propofol', 'continuous perioperative sedation', 'propofol was provided either ""as needed"" or by continuous infusion', 'sevoflurane']","['Perioperative sedation requirements', 'Intraoperative stress', 'additional intraoperative sedation', 'Comfort Behavioral Scale scores and heart rates']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002909', 'cui_str': 'Anesthesia, Sacral Epidural'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",32.0,0.232515,Significantly (p = 0.0001) less propofol was administered in the as-needed group (0.7 ± 1.4 mg/kg) than in the continuous-infusion group (3.0 ± 1.6 mg/kg).,"[{'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Schmid', 'Affiliation': 'Department of Anesthesiology and General Intensive Care Medicine, Medical University of Vienna, Vienna, Austria - werner.schmid@meduniwien.ac.at.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Marhofer', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Orthopedic Hospital Speising, Vienna, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kimberger', 'Affiliation': 'Department of Anesthesiology and General Intensive Care Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Marhofer', 'Affiliation': 'Department of Anesthesiology and General Intensive Care Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kettner', 'Affiliation': 'Vienna Hospital Association, Department of Anesthesiology and Intensive Care, Karl Landsteiner Institute for Anesthesiology and Intensive Care Medicine, Hospital Hietzing, Vienna, Austria.'}]",Minerva anestesiologica,['10.23736/S0375-9393.21.15716-5']
676,34351608,"Efficacy and Safety Results from a Phase 2, Randomized, Double-Blind Study of Enzalutamide Versus Placebo in Advanced Hepatocellular Carcinoma.","BACKGROUND AND OBJECTIVE


Hepatocellular carcinoma (HCC) is the fourth leading cause of cancer-related mortality worldwide. Despite recent advances, more effective therapeutic options for patients with advanced HCC are still required. The aim of this Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study (NCT02528643) was to investigate the potential benefit of enzalutamide in the treatment of patients with advanced HCC.
METHODS


Patients aged ≥ 18 years diagnosed with advanced HCC (Barcelona Clinic Liver Cancer stage B or C and Child-Pugh class A at screening who had progressed on, or were intolerant to, sorafenib or other anti-vascular endothelial growth factor therapies) were randomized 2:1 to receive either enzalutamide 160 mg daily or placebo. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS) and safety.
RESULTS


In total, 165 patients were randomized to enzalutamide (n = 110) or placebo (n = 55). The hazard ratio (HR) (95% confidence interval [CI]) for OS was 1.15 (0.774-1.696) and median OS was 7.8 months and 7.7 months for enzalutamide and placebo, respectively. The HR (95% CI) for PFS was 1.04 (0.732-1.474) and median PFS was 2.2 months and 1.9 months for enzalutamide and placebo, respectively. The overall frequency of treatment-emergent adverse events (TEAEs) was broadly similar between the groups: 105 (98.1%) enzalutamide patients experienced ≥1 TEAEs compared with 49 (89.1%) placebo patients.
CONCLUSIONS


The results of this study indicate that enzalutamide does not provide a benefit in patients with advanced HCC. No unexpected safety findings were observed in the trial. CLINICALTRIALS.
GOV IDENTIFIER


NCT02528643.",2021,"The HR (95% CI) for PFS was 1.04 (0.732-1.474) and median PFS was 2.2 months and 1.9 months for enzalutamide and placebo, respectively.","['Hepatocellular carcinoma (HCC', 'patients with advanced HCC', 'Patients aged ≥ 18 years diagnosed with advanced HCC (Barcelona Clinic Liver Cancer stage B or C and Child', '165 patients', 'Pugh class A at screening who had progressed on, or were intolerant to, sorafenib or other anti-vascular endothelial growth factor therapies', 'Advanced Hepatocellular Carcinoma']","['enzalutamide 160\xa0mg daily or placebo', 'Enzalutamide Versus Placebo', 'placebo', 'enzalutamide']","['Efficacy and Safety', 'PFS', 'median PFS', 'overall frequency of treatment-emergent adverse events (TEAEs', 'median OS', 'overall survival (OS); secondary endpoints included progression-free survival (PFS) and safety', 'hazard ratio (HR']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C0441781', 'cui_str': 'Stage B'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",165.0,0.759298,"The HR (95% CI) for PFS was 1.04 (0.732-1.474) and median PFS was 2.2 months and 1.9 months for enzalutamide and placebo, respectively.","[{'ForeName': 'Baek-Yeol', 'Initials': 'BY', 'LastName': 'Ryoo', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. ryooby@amc.seoul.kr.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': 'Liverpool CR UK/NIHR Experimental Cancer Medicine Centre, and The Clatterbridge Cancer Centre, Liverpool, UK.'}, {'ForeName': 'Sook Ryun', 'Initials': 'SR', 'LastName': 'Park', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Debashis Sarker', 'Affiliation': ""School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Daniele', 'Affiliation': 'Department of Oncology, G. Rummo Hospital, Benevento, Italy.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Steinberg', 'Affiliation': 'Astellas Pharma Inc., Northbrook, IL, USA.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'López', 'Affiliation': 'Data Science, Astellas Pharma Inc., Leiden, The Netherlands.'}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Division of Hematology-OncologyDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}]",Clinical drug investigation,['10.1007/s40261-021-01063-0']
677,34379236,Physical activity outcomes from a randomized trial of a theory- and technology-enhanced intervention for Latinas: the Seamos Activas II study.,"Latina women report disproportionately high and increasing prevalence of chronic health conditions (obesity, diabetes) related to low physical activity levels. Efforts to date at addressing high rates of physical inactivity in this at-risk population have shown modest success. The original Seamos Saludables (sample size N = 266) was a culturally and linguistically adapted, print-based physical activity intervention that showed significant increases in moderate to vigorous physical activity (MVPA) from baseline to 6 months. However, only 11% of intervention participants reached the national PA guidelines of ≥ 150 min/week of aerobic MVPA. The current study tests the original Seamos Saludables intervention (Original Intervention) against an enhanced iteration Seamos Activas II (Enhanced Intervention). Study aims and intervention refinements focus on increasing the percentage of Latinas meeting national aerobic PA guidelines. For the current study (Seamos Activas II), a randomized controlled trial with (N = 199 participants) of two PA interventions (original intervention, N = 102; vs. enhanced intervention, N = 97) was conducted. Intervention refinements involved further targeting key constructs of the Social Cognitive Theory and incorporating text-message-based strategies for self-monitoring, in response to participant feedback for greater interactivity and accountability. PA assessments were conducted at baseline and 6 months. The sample was predominantly Mexican American (89%) with average age of 43.8 years (SD = 10.11) and mean BMI at baseline was 30.6 (SD = 7.56). There were significant within group increases in MVPA from baseline to 6 months (p < .05) in both Original and Enhanced Intervention arms. However, quantile regression models did not indicate significant differences in 6-month outcomes between conditions controlling for baseline, p = 0.73. There were significant differences between conditions with respect to meeting national guidelines for aerobic MVPA at 6 months, with 57% of Enhanced Intervention participants meeting guidelines compared to 44% of Original Intervention participants, OR = 1.66, 95% CI: 1.09 -2.89. Models suggest trends favoring the enhanced condition for improvements in biomarkers over 6 months. Findings indicate that the intervention enhancements likely helped more Latinas achieve nationally recommended, health enhancing PA levels than the original intervention and showed promise for improving physiological response to exercise.Trial Registration ClinicalTrials.Gov; NCT02630953. Registered 14 December 2015. https://clinicaltrials.gov/ct2/show/NCT02630953 .",2022,There were significant within group increases in MVPA from baseline to 6 months (p < .05) in both Original and Enhanced Intervention arms.,"['Latinas', 'The sample was predominantly Mexican American (89%) with average age of 43.8\xa0years (SD\u2009=\u200910.11) and mean BMI at baseline was 30.6 (SD\u2009=\u20097.56', 'N\u2009=\u2009199 participants) of two', 'Latina women report disproportionately high and increasing prevalence of chronic health conditions (obesity, diabetes']","['PA interventions (original intervention, N\u2009=\u2009102; vs. enhanced intervention, N\u2009=\u200997', 'theory- and technology-enhanced intervention']","['MVPA', 'moderate to vigorous physical activity (MVPA', 'national PA guidelines', 'Physical activity outcomes']","[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025884', 'cui_str': 'Chicanos'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.071833,There were significant within group increases in MVPA from baseline to 6 months (p < .05) in both Original and Enhanced Intervention arms.,"[{'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Center for Health Promotion and Health Equity, School of Public Health, Brown University, 121 South Main Street, Providence, RI, 02903, USA. bess_marcus@brown.edu.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Center for Health Promotion and Health Equity, School of Public Health, Brown University, 121 South Main Street, Providence, RI, 02903, USA.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Pekmezi', 'Affiliation': 'School of Public Health, University of Alabama Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Benitez', 'Affiliation': 'Department of Behavioral and Social Sciences, Center for Health Promotion and Health Equity, School of Public Health, Brown University, 121 South Main Street, Providence, RI, 02903, USA.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Larsen', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Meyer', 'Affiliation': 'School of Medicine, University of California San Diego, La Jolla, CA, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-021-00246-6']
678,34330147,Validation of the triple-checked criteria for drain management after pancreatectomy.,"BACKGROUND


Drain management is important for the detection and treatment of clinically relevant postoperative pancreatic fistula (CR-POPF). We previously established the triple-checked criteria for drain removal: drain fluid amylase (DFA) <5000 U/L on postoperative day (POD) 1 and DFA <3000 U/L on POD 3, or C-reactive protein <15 mg/dL on POD 3. This study aimed to validate the efficacy of the triple-checked criteria.
METHODS


In this study, 681 patients who underwent pancreatectomy were included. Drains were removed according to our previous criteria (sequentially checked criteria: DFA <5000 U/L on POD 1 and DFA <3000 U/L on POD 3) from 2012 to 2016 (control group) and the triple-checked criteria from 2017 to 2019 (intervention group).
RESULTS


The control group included 406 patients, and the intervention group included 275 patients. Significantly more patients (n = 237, 86.2%) met the triple-checked criteria in the intervention group, relative to the sequentially checked criteria for early drain removal policy (n = 309, 76.1%; P = .001). Sensitivity, accuracy, and negative predictive value were significantly higher in the intervention group than in the control group (P < .001). The incidence of CR-POPF was not significantly different (11.1% vs 13.8%, P = .285).
CONCLUSIONS


The triple-checked criteria contributed to effective drain removal after pancreatectomy without increasing CR-POPF.",2022,"Significantly more patients (n=237, 86.2%) met the triple-checked criteria in the intervention group, relative to the sequentially-checked criteria for early drain removal policy (n=309, 76.1%; p=0.001).","['681 patients who underwent pancreatectomy were included', '406 patients, and the intervention group included 275 patients']","['DFA', 'drain removal: drain fluid amylase (DFA']","['incidence of CR-POPF', 'Sensitivity, accuracy, and negative predictive value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030279', 'cui_str': 'Pancreatectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517676', 'cui_str': '275'}]","[{'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",681.0,0.0510915,"Significantly more patients (n=237, 86.2%) met the triple-checked criteria in the intervention group, relative to the sequentially-checked criteria for early drain removal policy (n=309, 76.1%; p=0.001).","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Surgery, Kansai Medical University, Hirakata, Japan.'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Satoi', 'Affiliation': 'Department of Surgery, Kansai Medical University, Hirakata, Japan.'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Surgery, Kansai Medical University, Hirakata, Japan.'}, {'ForeName': 'So', 'Initials': 'S', 'LastName': 'Yamaki', 'Affiliation': 'Department of Surgery, Kansai Medical University, Hirakata, Japan.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Ishida', 'Affiliation': 'Department of Pathology and Clinical Laboratory, Kansai Medical University, Hirakata, Japan.'}, {'ForeName': 'Tatsuma', 'Initials': 'T', 'LastName': 'Sakaguchi', 'Affiliation': 'Department of Surgery, Kansai Medical University, Hirakata, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hirooka', 'Affiliation': 'Department of Surgery, Kansai Medical University, Hirakata, Japan.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Ikeura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kansai Medical University, Hirakata, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Department of Surgery, Kansai Medical University, Hirakata, Japan.'}, {'ForeName': 'Mitsugu', 'Initials': 'M', 'LastName': 'Sekimoto', 'Affiliation': 'Department of Surgery, Kansai Medical University, Hirakata, Japan.'}]",Journal of hepato-biliary-pancreatic sciences,['10.1002/jhbp.1030']
679,34351426,Rationale and design of the pragmatic clinical trial tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT).,"BACKGROUND


There is a lack of evidence regarding the benefits of β-blocker treatment after invasively managed acute myocardial infarction (MI) without reduced left ventricular ejection fraction (LVEF).
METHODS AND RESULTS


TREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fraction (REBOOT) trial is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial testing the benefits of β-blocker maintenance therapy in patients discharged after MI with or without ST-segment elevation. Patients eligible for participation are those managed invasively during index hospitalization (coronary angiography), with LVEF >40%, and no history of heart failure (HF). At discharge, patients will be randomized 1:1 to β-blocker therapy (agent and dose according to treating physician) or no β-blocker therapy. The primary endpoint is a composite of all-cause death, nonfatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 years (minimum 2 years, maximum 3 years). Key secondary endpoints include the incidence of the individual components of the primary composite endpoint, the incidence of cardiac death, and incidence of malignant ventricular arrhythmias or resuscitated cardiac arrest. The primary endpoint will be analyzed according to the intention-to-treat principle.
CONCLUSION


The REBOOT trial will provide robust evidence to guide the prescription of β-blockers to patients discharged after MI without reduced LVEF.",2021,"The primary endpoint is a composite of all-cause death, nonfatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 years (minimum 2 years, maximum 3 years).","['Patients eligible for participation are those managed invasively during index hospitalization (coronary angiography), with LVEF >40%, and no history of heart failure (HF', 'patients discharged after MI with or without ST-segment elevation', 'TREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fraction (REBOOT) trial']","['β-blocker therapy (agent and dose according to treating physician) or no β-blocker therapy', 'β-blocker maintenance therapy', 'Beta-blockers']","['incidence of the individual components of the primary composite endpoint, the incidence of cardiac death, and incidence of malignant ventricular arrhythmias or resuscitated cardiac arrest', 'composite of all-cause death, nonfatal reinfarction, or HF hospitalization', 'intention-to-treat principle']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]",,0.20457,"The primary endpoint is a composite of all-cause death, nonfatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 years (minimum 2 years, maximum 3 years).","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Rossello', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Raposeiras-Roubin', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Latini', 'Affiliation': 'Department of Cardiovascular Medicine. Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Dominguez-Rodriguez', 'Affiliation': 'CIBER de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Barrabés', 'Affiliation': 'CIBER de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Sánchez', 'Affiliation': 'CIBER de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Anguita', 'Affiliation': 'Department of Cardiology, Hospital Universitario Reina Sofía de Cordoba, Córdoba, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fernández-Vázquez', 'Affiliation': 'Cardiology Department, Hospital Universitario de León, León, Spain.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Pascual-Figal', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'De la Torre Hernandez', 'Affiliation': 'Cardiology Department, Hospital Marques de Valdecilla, Santander, IDIVAL, Spain.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ferraro', 'Affiliation': 'Cardiology Department, Ospedale Guglielmo da Saliceto, Piacenza, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Vetrano', 'Affiliation': 'Cardiology Department, Ospedale S. Anna e S. Sebastiano, Caserta, Italy.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Pérez-Rivera', 'Affiliation': 'Department of Cardiology, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Prada-Delgado', 'Affiliation': 'Department of Cardiology, Hospital Universitario A Coruña, A Coruña, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Escalera', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Staszewsky', 'Affiliation': 'Department of Cardiovascular Medicine. Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Pizarro', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Agüero', 'Affiliation': 'CIBER de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Ottani', 'Affiliation': 'Cardiology Department, Ospedale Vizzolo Predabissi di Melegnano, Milan, Italy.'}, {'ForeName': 'Valentín', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Ibáñez', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvab060']
680,34355354,Early Data on Long-term Impact of Inotersen on Quality-of-Life in Patients with Hereditary Transthyretin Amyloidosis Polyneuropathy: Open-Label Extension of NEURO-TTR.,"INTRODUCTION


Patients with hereditary transthyretin amyloidosis associated with polyneuropathy (ATTRv-PN) experience deterioration in health-related quality of life (HRQOL) as the disease progresses. Findings from the randomized placebo-controlled phase III NEURO-TTR study showed treatment benefit of inotersen, an antisense oligonucleotide, for preserving or improving HRQOL after 65 weeks of treatment. The current analysis examines longitudinal trends in specific aspects of HRQOL, including polyneuropathy symptoms, daily activities, and physical, role, and social functioning in patients with ATTRv-PN receiving long-term treatment in a follow-up open-label extension (OLE) study.
METHODS


One-hundred thirty-five patients with ATTRv-PN were enrolled in an ongoing 5-year OLE study following completion of NEURO-TTR. Eighty-five patients received continuous weekly treatment with inotersen in both studies (inotersen-inotersen group), while 50 patients switched from placebo to inotersen at OLE study baseline (placebo-inotersen group). Descriptive analyses of changes in domain scores and item responses through week 104 of the OLE study were conducted for measures of neuropathy-related and generic HRQOL: Norfolk QOL-Diabetic Neuropathy (DN) questionnaire and SF-36v2® Health Survey (SF-36v2), respectively.
RESULTS


For both inotersen-inotersen and placebo-inotersen groups, all Norfolk QOL-DN and most SF-36v2 domain scores remained stable from OLE baseline through week 104. Differences in HRQOL between the two groups at OLE baseline were sustained through week 104. Analysis of item responses from NEURO-TTR baseline to OLE study week 104 (170 weeks) for the inotersen-inotersen group found no notable increases in the proportion of patients reporting substantial impairments across a wide variety of symptoms, daily activities, and functioning.
CONCLUSION


Long-term treatment with inotersen preserved HRQOL for patients with ATTRv-PN for periods of up to 3 years. The gap in HRQOL between those who had previously received inotersen or placebo in NEURO-TTR did not close by week 104 of the OLE phase, indicating the importance of early treatment for maintaining HRQOL in these patients.
TRIAL REGISTRATION


ClinicalTrials.gov Identifiers NCT01737398 for NEURO-TTR study; NCT02175004 for OLE study INFOGRAPHIC.",2021,Long-term treatment with inotersen preserved HRQOL for patients with ATTRv-PN for periods of up to 3 years.,"['patients with ATTRv-PN receiving long-term treatment in a follow-up open-label extension (OLE) study', 'One-hundred thirty-five patients with ATTRv-PN were enrolled in an ongoing 5-year OLE study following completion of NEURO-TTR', 'Patients with Hereditary Transthyretin Amyloidosis Polyneuropathy']","['placebo', 'placebo to inotersen at OLE study baseline (placebo-inotersen group']","['polyneuropathy symptoms, daily activities, and physical, role, and social functioning', 'HRQOL', 'proportion of patients reporting substantial impairments across a wide variety of symptoms, daily activities, and functioning', 'Quality-of-Life', 'neuropathy-related and generic HRQOL: Norfolk QOL-Diabetic Neuropathy (DN) questionnaire and SF-36v2® Health Survey (SF-36v2', 'Norfolk QOL-DN and most SF-36v2 domain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C2751492', 'cui_str': 'Hereditary Amyloidosis, Transthyretin-Related'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4731850', 'cui_str': 'inotersen'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0454866', 'cui_str': 'Norfolk'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",135.0,0.146943,Long-term treatment with inotersen preserved HRQOL for patients with ATTRv-PN for periods of up to 3 years.,"[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Yarlas', 'Affiliation': 'QualityMetric, 1301 Atwood Avenue, Suite 316E, Johnston, RI, 02919, USA. ayarlas@qualitymetric.com.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lovley', 'Affiliation': 'QualityMetric, 1301 Atwood Avenue, Suite 316E, Johnston, RI, 02919, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'McCausland', 'Affiliation': 'QualityMetric, 1301 Atwood Avenue, Suite 316E, Johnston, RI, 02919, USA.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Ionis Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Vera-Llonch', 'Affiliation': 'Ionis Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Conceição', 'Affiliation': 'Centro Hospitalar Universitário Lisboa Norte, Hospital de Santa Maria and Faculdade de Medicina, Lisbon, Portugal.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Khella', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Obici', 'Affiliation': 'Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Waddington-Cruz', 'Affiliation': 'Federal University of Rio de Janeiro, National Amyloidosis Referral Center, CEPARM, Rio de Janeiro, Brazil.'}]",Neurology and therapy,['10.1007/s40120-021-00268-x']
681,34362779,A randomized controlled trial on the effect of dietary guidance on the treatment of Henoch-Schonlein purpura in children.,"The amino acid-based formulae were extensively added to diet of children for the treatment of Henoch-Schonlein purpura (HSP), and the nutrition and growth situation of children were evaluated after giving new dietary intervention. Patients were randomly divided into restricted diet group (n=30) and dietary guidance group (n=30). Besides, 30 cases with bronchiolitis who had normal diet were selected as the control group. The dietary questionnaire was designed to record the types and intakes of various foods taken by children every day, and the intake levels of nutrients were analyzed. Physical examination, biochemical analysis of blood and urine routine were carried out to evaluate the effect of dietary guidance on their growth and development. The results showed that restricted diet group had lower levels of nutrient intake and the actual/recommended percentage. However, overall nutrient intake level of the dietary guidance group was higher, basically equal to the recommended intake level. Besides, the actual intake and actual/recommended percentage of nutrients of dietary guidance group were significantly higher than those of restricted diet group (p<0.05). Dietary guidance can improve nutrients and protein intake of children with HSP, and reduce the relapse of rash and incidence of complications.",2021,"Dietary guidance can improve nutrients and protein intake of children with HSP, and reduce the relapse of rash and incidence of complications.","['children with HSP', '30 cases with bronchiolitis who had normal diet', 'Henoch-Schonlein purpura in children']","['dietary guidance', 'dietary guidance group']","['relapse of rash and incidence of complications', 'lower levels of nutrient intake', 'overall nutrient intake level']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034152', 'cui_str': 'Henoch-Schönlein purpura'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",30.0,0.0244977,"Dietary guidance can improve nutrients and protein intake of children with HSP, and reduce the relapse of rash and incidence of complications.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Pediatrics, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Yin', 'Affiliation': ""Department of Pediatrics, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Meizhen', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Pediatrics, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Mao', 'Affiliation': ""Department of Pediatrics, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Huixiang', 'Initials': 'H', 'LastName': 'Hao', 'Affiliation': ""Department of Pediatrics, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Department of Pediatrics, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Wanli', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': ""Department of Nutrition and Food Safety Research, School of Public Health, Xi'an Jiaotong University, Xi'an, Shaanxi, China xuewl@mail.xjtu.edu.cn.""}]",Journal of investigative medicine : the official publication of the American Federation for Clinical Research,['10.1136/jim-2021-001984']
682,34366180,Traditional Versus Digital Media-Based Hand Therapy After Distal Radius Fracture.,"PURPOSE


Distal radius fractures (DRFs) are common injuries with a rising incidence. A substantial portion of the cost of care is attributable to therapy services. Our purpose was to evaluate the effectiveness of a self-directed hand therapy program guided by digital media compared with that of traditional therapy.
METHODS


We conducted a randomized controlled trial in patients aged 18 years or older who underwent open reduction and internal fixation of a DRF with volar plating. Subjects were randomized to traditional hand therapy using a 12-week protocol or an identical protocol presented in digital videos and performed at home. Disabilities of the Arm, Shoulder, and Hand (QuickDASH) scores were collected as the primary outcome at 2 weeks (baseline), 6 weeks, and 12 weeks or greater. Pain visual analog scale (VAS) scores, Veterans RAND 12-Item Health Survey (VR-12) scores, wrist and forearm range of motion, wrist circumference, and grip strength were recorded as secondary outcomes.
RESULTS


Fifty-one patients were enrolled. Forty-nine patients were included in the analysis-21 in the digital media group and 28 in the traditional group. Both groups demonstrated significant improvements in QuickDASH scores between baseline and 12-week or greater time points. The QuickDASH scores in the digital media group were slightly more improved than those in the traditional group at the 6-week and 12-week or greater time points; however, these differences were not statistically significant. Pain VAS and VR-12 scores were comparable between group differences at each time point.
CONCLUSIONS


Our digital media program was at least as effective as traditional therapy for patients undergoing volar plating of DRF. These results may help inform the design of future trials investigating the effectiveness of digital media-based hand therapy programs.
TYPE OF STUDY/LEVEL OF EVIDENCE


Therapeutic II.",2022,"The QuickDASH scores in the digital media group were slightly more improved than those in the traditional group at the 6-week and 12-week or greater time points; however, these differences were not statistically significant.","['Forty-nine patients were included in the analysis-21 in the digital media group and 28 in the traditional group', 'Fifty-one patients were enrolled', 'patients undergoing volar plating of DRF', 'patients aged 18 years or older who underwent open reduction and internal fixation of a DRF with volar plating']","['traditional hand therapy using a 12-week protocol or an identical protocol presented in digital videos and performed at home', 'Traditional Versus Digital Media-Based Hand Therapy']","['Pain visual analog scale (VAS) scores, Veterans RAND 12-Item Health Survey (VR-12) scores, wrist and forearm range of motion, wrist circumference, and grip strength', 'Pain VAS and VR-12 scores', 'QuickDASH scores', 'Disabilities of the Arm, Shoulder, and Hand (QuickDASH) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",51.0,0.0242891,"The QuickDASH scores in the digital media group were slightly more improved than those in the traditional group at the 6-week and 12-week or greater time points; however, these differences were not statistically significant.","[{'ForeName': 'Taylor R', 'Initials': 'TR', 'LastName': 'Lara', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Ryland P', 'Initials': 'RP', 'LastName': 'Kagan', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Hiratzka', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Austin R', 'Initials': 'AR', 'LastName': 'Thompson', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Omar F', 'Initials': 'OF', 'LastName': 'Nazir', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Mirarchi', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR. Electronic address: mirarchi@ohsu.edu.'}]",The Journal of hand surgery,['10.1016/j.jhsa.2021.06.018']
683,34378863,"Efficacy of high versus conventional dose of ergocalciferol supplementation on serum 25-hydroxyvitamin D and interleukin-6 levels among hemodialysis patients with vitamin D deficiency: A multicenter, randomized, controlled study.","Long-term dialysis involves a chronic inflammatory state and produces a high prevalence of vitamin D deficiency. A clinical trial was conducted in hemodialysis with serum 25-hydroxyvitamin D (25[OH]D) level <30 ng/ml. The conventional-group (N = 35) and the high-dose group (N = 35) were treated with ergocalciferol according to the K/DOQI guidelines and double dosage of ergocalciferol from the recommendation for 8 weeks, respectively. The main outcomes were measured by serum 25[OH]D and interleukin-6 (IL-6). At the end of 8 weeks, a statistically significant greater increase was observed of mean serum 25[OH]D levels and a decrease of mean parathyroid hormone levels in the high-dose group compared with the conventional-dose group. The high dose group had the higher achievement of vitamin D sufficiency than the conventional-dose group (97.4% vs. 76.4%, p = 0.012). No significant difference was found in mean changes of serum IL-6 level in both groups, except subgroup patients with vitamin D deficiency or serum 25[OH]D <20 ng/ml, high dose treatment suppressed serum IL-6 level (-2.67 pg/ml [IQR -6.56 to -0.17], p = 0.039). No differences were observed between the two groups in adverse events. Oral high-dose ergocalciferol supplementation has achieved higher vitamin D sufficiency than standard dose in end stage renal disease patients on dialysis.",2022,"At the end of 8 weeks, a statistically significantly greater increase was observed of mean serum 25[OH]D levels and decrease of mean PTH levels in the high-dose group compared with the conventional-dose group.","['subgroup patients with vitamin D deficiency or serum', 'ESRD patients on dialysis', 'Hemodialysis Patients with Vitamin D Deficiency', 'hemodialysis with serum 25-hydroxyvitamin D (25[OH]D) level\u2009<\u200930']","['Oral high-dose ergocalciferol supplementation', 'Ergocalciferol Supplementation', 'ergocalciferol according to the K/DOQI guidelines and double dosage of ergocalciferol']","['adverse events', 'serum IL-6 level', 'mean serum 25[OH]D levels', 'serum 25[OH]D and interleukin-6 (IL-6', 'mean PTH levels', 'Serum 25-Hydroxyvitamin D and Interleukin-6 Levels', 'vitamin D sufficiency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",35.0,0.199123,"At the end of 8 weeks, a statistically significantly greater increase was observed of mean serum 25[OH]D levels and decrease of mean PTH levels in the high-dose group compared with the conventional-dose group.","[{'ForeName': 'Naowanit', 'Initials': 'N', 'LastName': 'Nata', 'Affiliation': 'Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Wittaya', 'Initials': 'W', 'LastName': 'Siricheepchaiyan', 'Affiliation': 'Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Ouppatham', 'Initials': 'O', 'LastName': 'Supasyndh', 'Affiliation': 'Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Bancha', 'Initials': 'B', 'LastName': 'Satirapoj', 'Affiliation': 'Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.13722']
684,34351820,Efficacy of Online Learning Modules for Teaching Dialogic Reading Strategies and Phonemic Awareness.,"Purpose The purpose of this study was to create and evaluate online learning modules designed to teach speech-language pathologists (SLPs) dialogic reading strategies and phonemic awareness skills. Method School-based SLPs ( n  = 28) were assigned to complete one of two online learning modules. One module taught dialogic reading strategies, and the other taught phonemic awareness. Participants in the dialogic reading group served as controls for the phonemic awareness group and vice versa. Participants completed a pretest that assessed phonemic awareness skill and knowledge of dialogic reading strategies to control for prior knowledge and skill, completed their assigned module, and then completed a posttest that assessed phonemic awareness skill and knowledge of dialogic reading strategies. Results Data were analyzed using multiple regression. The independent variables were pretest score, group, and the pretest score by group interaction. The dependent variable in the first model was posttest score on the dialogic reading measure. The dependent variable in the second model was posttest score on the phonemic awareness measure. There was a statistically significant group by posttest score interaction in the dialogic reading model, indicating that the dialogic reading module was effective for improving knowledge of dialogic reading strategies. There was not a statistically significant group by posttest score interaction in the phonemic awareness module, indicating that the phonemic awareness module was not effective for improving phoneme segmentation skill and phoneme manipulation skill. Conclusions Online learning modules may be effective for establishing knowledge needed for evidence-based practice in speech-language pathology. Additional research is warranted to determine whether online learning modules can be used to change clinician intervention behavior.",2021,"There was not a statistically significant group by posttest score interaction in the phonemic awareness module, indicating that the phonemic awareness module was not effective for improving phoneme segmentation skill and phoneme manipulation skill.",['Method School-based SLPs ( n  = 28'],"['dialogic reading group served as controls for the phonemic awareness group and vice versa', 'online learning modules designed to teach speech-language pathologists (SLPs) dialogic reading strategies and phonemic awareness skills', 'Online Learning Modules']","['phoneme segmentation skill and phoneme manipulation skill', 'knowledge of dialogic reading strategies', 'phonemic awareness skill and knowledge of dialogic reading strategies']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0334866', 'cui_str': 'Medical pathologist'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C4505477', 'cui_str': 'Online Education'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0334866', 'cui_str': 'Medical pathologist'}]","[{'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",28.0,0.0239135,"There was not a statistically significant group by posttest score interaction in the phonemic awareness module, indicating that the phonemic awareness module was not effective for improving phoneme segmentation skill and phoneme manipulation skill.","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Krimm', 'Affiliation': 'Department of Communication Sciences and Special Education, University of Georgia, Athens.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Lund', 'Affiliation': 'Davies School of Communication Sciences & Disorders, Texas Christian University, Fort Worth.'}]","Language, speech, and hearing services in schools",['10.1044/2021_LSHSS-21-00011']
685,34355232,Predictors of Lack of Relapse After Random Discontinuation of Oral and Long-acting Injectable Antipsychotics in Clinically Stabilized Patients with Schizophrenia: A Re-analysis of Individual Participant Data.,"OBJECTIVE


To quantify the risk and predictors of relapse among individuals with schizophrenia randomly withdrawn from antipsychotic maintenance treatment.
METHODS


We re-analyzed time-to-event and baseline predictors from placebo arms in five placebo-controlled randomized trials of antipsychotics (n = 688 individuals; 173 stabilized on oral antipsychotic [OAP] and 515 on long-acting injectables [LAI]) for relapse-prevention available in the Yale Open Data Access repository. Using a survival and Cox-proportional hazards regression analyses, we estimated survival rates of ""relapse-free"" individuals by the end of follow-up (median = 118 days, IQR = 52.0-208.0), the rate of study-confirmed relapse, and adjusted hazard ratios (aHR, 95% confidence intervals [CI]) associated with baseline predictors. We also estimated these parameters for individuals followed for >5 half-lives of the stabilizing antipsychotic, and studied predictors of ""rebound psychosis"" in OAP-stabilized participants, defined as occurring within 30 days of antipsychotic withdrawal.
RESULTS


29.9% (95%CI = 23.2-38.5) remained relapse-free by the end of follow-up, 11.1% (95%CI = 5.65-21.9) among those OAP-stabilized, 36.4% (95%CI = 28.4-46.7) among those LAI-stabilized. The study-confirmed relapse rate was 45.2%, 62.4% among those OAP-stabilized and 39.4% among those LAI-stabilized. Predictors of relapse included smoking (aHR = 1.54, 95%CI = 1.19-2.00), female sex (aHR = 1.37, 95%CI = 1.08-1.79), and having been stabilized on OAPs vs LAIs (aHR = 3.56, 95%CI = 2.68-4.72). Greater risk of relapse on OAP persisted even after sufficient time had elapsed to clear antipsychotic plasma level among LAI-stabilized (aHR = 5.0, 95%CI = 3.5-7.1). ""Rebound psychosis"" did not show predictors.
CONCLUSIONS AND RELEVANCE


Our results corroborate the high relapse risk following antipsychotic withdrawal after symptom stabilization with limited patient-related predictors of safe treatment discontinuation. Stabilization with LAIs reduces the short-/medium-term relapse risk.",2022,"Predictors of relapse included smoking (aHR = 1.54, 95%CI = 1.19-2.00), female sex (aHR = 1.37, 95%CI = 1.08-1.79), and having been stabilized on OAPs vs LAIs (aHR = 3.56, 95%CI = 2.68-4.72).","['individuals with schizophrenia randomly withdrawn from antipsychotic maintenance treatment', 'Clinically Stabilized Patients with Schizophrenia', 'n = 688 individuals']","['LAIs', 'oral antipsychotic [OAP', 'long-acting injectables [LAI', 'antipsychotics', 'placebo', 'Oral and Long-acting Injectable Antipsychotics']","['survival rates of ""relapse-free"" individuals', 'Greater risk of relapse on OAP', 'short-/medium-term relapse risk', 'relapse-free', 'Lack of Relapse', 'relapse rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443021', 'cui_str': 'Lai'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0069290', 'cui_str': 'OAP protocol'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0069290', 'cui_str': 'OAP protocol'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}]",688.0,0.53358,"Predictors of relapse included smoking (aHR = 1.54, 95%CI = 1.19-2.00), female sex (aHR = 1.37, 95%CI = 1.08-1.79), and having been stabilized on OAPs vs LAIs (aHR = 3.56, 95%CI = 2.68-4.72).","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Schoretsanitis', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Hospital of Psychiatry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kane', 'Affiliation': 'Department of Psychiatry, Northwell Health, The Zucker Hillside Hospital, Glen Oaks, NY, USA.'}, {'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'Department of Psychiatry, Northwell Health, The Zucker Hillside Hospital, Glen Oaks, NY, USA.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Rubio', 'Affiliation': 'Department of Psychiatry, Northwell Health, The Zucker Hillside Hospital, Glen Oaks, NY, USA.'}]",Schizophrenia bulletin,['10.1093/schbul/sbab091']
686,34362713,Predictive value of geriatric oncology screening and geriatric assessment of older patients with cancer: A randomized clinical trial protocol (PROGNOSIS-RCT).,"INTRODUCTION


Comprehensive geriatric assessment (CGA) has been shown to reduce frailty in older patients in general. In older patients with cancer, frailty affects quality of life (QoL), physical function, and survival. However, few studies have examined the effect of CGA as an additional intervention to antineoplastic treatment. This protocol presents a randomized controlled trial, which aims to evaluate the effects of CGA-based interventions in older patients with cancer and Geriatric 8 (G8) identified frailty.
MATERIALS AND METHODS


This randomized controlled trial will include patients, age 70+ years, with solid malignancies and G8 frailty (G8 ≤ 14). Patients will be separated into two groups, with different primary endpoints, depending on palliative or curative antineoplastic treatment initiation, and subsequently randomized 1:1 to either CGA with corresponding interventions or standard of care, along with standardized antineoplastic treatment. A geriatrician led CGA with corresponding interventions and clinical follow-up will be conducted within one month of antineoplastic treatment initiation. The interdisciplinary CGA will cover multiple geriatric domains and employ a standard set of validated assessment tools. Primary endpoints will be physical decline measured with the 30-s Chair-Stand-Test at three months (palliative setting) and unplanned hospital admissions at six months (curative setting). Additional outcomes include QoL, treatment toxicity and adherence, occurrence of polypharmacy, potential drug interactions, potential inappropriate medications, and survival. The primary outcomes will be analyzed using a mixed model regression analysis (30-s chair stand test) and linear regression models (unplanned hospitalizations), with an intention to treat approach. Power calculations reveal the need to enroll 134 (palliative) and 188 (curative) patients.
DISCUSSION


The present study will examine whether CGA, as an additional intervention to antineoplastic treatment, can improve endpoints valued by older patients with cancer. Inclusion began November 2020 and is ongoing, with 37 and 29 patients recruited April 15th, 2021. Registration:NCT04686851.",2022,"This protocol presents a randomized controlled trial, which aims to evaluate the effects of CGA-based interventions in older patients with cancer and Geriatric 8 (G8) identified frailty.
","['older patients with cancer and Geriatric 8 (G8) identified frailty', 'enroll 134 (palliative) and 188 (curative) patients', 'Inclusion began November 2020 and is ongoing, with 37 and 29 patients recruited April 15th, 2021', 'older patients in general', 'older patients with cancer', 'patients, age 70+ years, with solid malignancies and G8 frailty (G8 ≤ 14']","['Comprehensive geriatric assessment (CGA', 'geriatric oncology screening and geriatric assessment', 'CGA-based interventions', 'CGA with corresponding interventions or standard of care, along with standardized antineoplastic treatment', 'CGA']","['quality of life (QoL), physical function, and survival', 'QoL, treatment toxicity and adherence, occurrence of polypharmacy, potential drug interactions, potential inappropriate medications, and survival', 'physical decline measured with the 30-s Chair-Stand-Test at three months (palliative setting) and unplanned hospital admissions', 'mixed model regression analysis (30-s chair stand test) and linear regression models (unplanned hospitalizations), with an intention to treat approach']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205208', 'cui_str': 'Solid'}]","[{'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0678798', 'cui_str': 'Adverse drug interaction'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0034980', 'cui_str': 'Analysis, Regression'}, {'cui': 'C0023733', 'cui_str': 'Linear Regression'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",,0.203507,"This protocol presents a randomized controlled trial, which aims to evaluate the effects of CGA-based interventions in older patients with cancer and Geriatric 8 (G8) identified frailty.
","[{'ForeName': 'Ann-Kristine Weber', 'Initials': 'AW', 'LastName': 'Giger', 'Affiliation': 'Department of Geriatric Medicine, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark. Electronic address: Ann-Kristine.Weber.Giger@rsyd.dk.'}, {'ForeName': 'Helena Møgelbjerg', 'Initials': 'HM', 'LastName': 'Ditzel', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark; Department of Oncology, Odense University Hospital, Denmark.'}, {'ForeName': 'Trine Lembrecht', 'Initials': 'TL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark; Department of Oncology, Odense University Hospital, Denmark.'}, {'ForeName': 'Henrik Jørn', 'Initials': 'HJ', 'LastName': 'Ditzel', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark; Department of Oncology, Odense University Hospital, Denmark.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Mohammadnejad', 'Affiliation': 'Department of Public Health, University of Southern Denmark, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Ewertz', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark; Department of Oncology, Odense University Hospital, Denmark.'}, {'ForeName': 'Cecilia Margareta', 'Initials': 'CM', 'LastName': 'Lund', 'Affiliation': 'Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark; Department of Medicine, Copenhagen University Hospital, Herlev and Gentofte, Denmark; CopenAge, Copenhagen Center for Clinical Age research, University of Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Ryg', 'Affiliation': 'Department of Geriatric Medicine, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Denmark.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2021.07.005']
687,34375444,Mechanisms of change in acceptance and commitment therapy for primary headaches.,"BACKGROUND


Despite the demonstrated effectiveness of behavioural headache interventions, it is not yet known which intervention processes account for treatment responses. Acceptance and commitment therapy (ACT), an emerging behavioural intervention for headaches, proposes psychological flexibility (PF) processes as the mechanisms via which intervention change occurs. This is the first study examining these processes of change variables on headache-related disability and quality of life (treatment outcome).
METHODS


Data originated from a Randomized Clinical Trial evaluating the efficacy of ACT for primary headaches. Ninety-four individuals with primary headaches (M = 43 y; 84% females; M headache frequency/month = 9.30) were randomized to either an ACT-based or a Wait-list control group (N = 47 in each). Participants completed questionnaires related to their headache experiences and PF processes at pre- (T1), post-treatment (T2), and 3-month follow-up (T3).
RESULTS


Following a bootstrapped cross product of coefficients approach, results demonstrated mediating effects of headache acceptance, cognitive defusion, avoidance of headache, and mindfulness in the ACT group compared to control on parameters of headache-related disability and quality of life at post and 3-month follow-ups.
CONCLUSIONS


These findings demonstrate that changes in certain PF processes lower disability and improve quality of life in headache sufferers, supporting that ACT works via its proposed mechanisms of change. Interventions for headache management may be optimized if they target increases in headache acceptance, defusion from thoughts, and mindfulness.
SIGNIFICANCE


Psychological flexibility (PF) guides the ACT approach, an emerging behavioral headache intervention that focuses on optimizing head pain adjustment via flexible responses to pain. It targets at increasing daily functioning rather than preventing or controlling headache episodes. Pain acceptance, cognitive defusion, and mindfulness act as processes of functional change in ACT, lowering disability and increasing daily functioning and quality of life. These components can upgrade the established effectiveness of behavioral headache interventions with personalized, modularized therapeutic targets that can help headache sufferers re-establish optimal daily functioning even in fluctuating and persistent headache episodes.
TRIAL REGISTRATION


clinical trials.gov registry (NCT02734992).",2022,"Interventions for headache management may be optimized if they target increases in headache acceptance, defusion from thoughts, and mindfulness.","['headache sufferers', 'Ninety-four individuals with primary headaches (M=43 yrs; 84% females; M headache frequency/month=9.30', 'primary headaches', 'Primary Headaches']","['Acceptance and commitment therapy (ACT', 'ACT-based or a Wait-list control group', 'ACT']","['headache-related disability and quality of life', 'headache experiences and PF processes', 'quality of life', 'headache acceptance, cognitive defusion, avoidance of headache, and mindfulness']","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",94.0,0.0358457,"Interventions for headache management may be optimized if they target increases in headache acceptance, defusion from thoughts, and mindfulness.","[{'ForeName': 'Vasilis S', 'Initials': 'VS', 'LastName': 'Vasiliou', 'Affiliation': 'Department of Applied Psychology, University College Cork, Cork, Ireland.'}, {'ForeName': 'Evangelos C', 'Initials': 'EC', 'LastName': 'Karademas', 'Affiliation': 'Department of Psychology, University of Crete, Rethymnon, Greece.'}, {'ForeName': 'Yiolanda', 'Initials': 'Y', 'LastName': 'Christou', 'Affiliation': ""Neurology Clinic B', The Cyprus Institute of Neurology and Genetics, Egkomi, Cyprus.""}, {'ForeName': 'Savvas', 'Initials': 'S', 'LastName': 'Papacostas', 'Affiliation': ""Neurology Clinic B', The Cyprus Institute of Neurology and Genetics, Egkomi, Cyprus.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Karekla', 'Affiliation': 'Department of Psychology, ACTHealthy Laboratory, University of Cyprus, Nicosia, Cyprus.'}]","European journal of pain (London, England)",['10.1002/ejp.1851']
688,34378159,Effects of remote ischemic postconditioning on HIF-1α and other markers in on-pump cardiac surgery.,"BACKGROUND


There is a lack of data about the effects of remote ischemic postconditioning (RIPostC) on hypoxia-inducible factor-1α (HIF-1α) plasma levels after on-pump cardiac surgery (OPCS). This study aimed to measure the effects of RIPostC on postoperative HIF-1α plasma levels, cardiac markers and arterial oxygenation in patients undergoing OPCS.
METHODS


This single-centre randomized, double blind, controlled trial, enrolled 70 patients (35 control and 35 RIPostC). RIPostC was performed by 3 cycles (5 min of ischemia followed by 5 min of reperfusion) administered in upper arm immediately after the pump period. The primary outcome was to measure HIF-1α plasma levels: before surgery (T0), and 2 h (T1), 8 h (T2), 24 h (T3), 36 h (T4) and 48 h (T5) after RIPostC. As secondary endpoint, Troponin T, CK-MB, CPK plasma levels and PaO 2 /FiO 2  ratio were measured.
RESULTS


HIF-1α plasma levels were increased at T1-T3 compared to T0 in both groups (P < 0.001). In the RIPostC group HIF-1α increased compared to the control group: differences between means (95% CI) were 0.034 (0.006-0.06) P = 0.019 at T1; 0.041 (0.013-0.069) P = 0.005 at T2; and 0.021 (0.001-0.042) P = 0.045 at T3. PaO 2 /FiO 2  was higher in the RIPostC group than in the control group: at T3, T4 and T5. Moreover, Troponin T, CK-MB and CPK values decreased in the RIPostC group compared to the control group.
CONCLUSIONS


HIF-1α plasma levels increased in control patients during for at least 36 h after OPCS. RIPostC resulted in even higher HIF-1α levels during at least the first 24 h and improved arterial oxygenation and cardiac markers.",2022,"Moreover, Troponin T, CK-MB and CPK values decreased in the RIPostC group compared to the control group.
","['patients undergoing OPCS', 'enrolled 70 patients (35 control and 35 RIPostC']","['remote ischemic postconditioning', 'remote ischemic postconditioning (RIPostC', 'RIPostC']","['HIF-1α plasma levels', 'PaO 2 /FiO 2', 'HIF-1α levels', 'Troponin T, CK-MB, CPK plasma levels and PaO 2 /FiO 2  ratio', 'hypoxia-inducible factor-1α (HIF-1α) plasma levels', 'postoperative HIF-1α plasma levels, cardiac markers and arterial oxygenation', 'Troponin T, CK-MB and CPK values', 'arterial oxygenation and cardiac markers', 'HIF-1α plasma levels: before surgery (T0), and 2\xa0h (T1), 8\xa0h (T2), 24\xa0h (T3), 36\xa0h (T4) and 48\xa0h (T5) after RIPostC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C2936234', 'cui_str': 'Ischemic Post-Conditioning'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C2936234', 'cui_str': 'Ischemic Post-Conditioning'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1271630', 'cui_str': 'Cardiac markers'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C2936234', 'cui_str': 'Ischemic Post-Conditioning'}]",70.0,0.434038,"Moreover, Troponin T, CK-MB and CPK values decreased in the RIPostC group compared to the control group.
","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'García-de-la-Asunción', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Hospital Clínico Universitario, Instituto de Investigación Sanitaria-INCLIVA, Valencia, Spain. josegarciadelaasuncion@gmail.com.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Moreno', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Hospital Clínico Universitario, Instituto de Investigación Sanitaria-INCLIVA, Valencia, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Duca', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Hospital Clínico Universitario, Instituto de Investigación Sanitaria-INCLIVA, Valencia, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'García-Del-Olmo', 'Affiliation': 'Department of General Surgery, Hospital Lluís Alcanyís, Xàtiva, Spain.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Perez-Griera', 'Affiliation': 'Laboratory of Biochemistry, Hospital Clínico Universitario, Instituto de Investigación Sanitaria-INCLIVA, Valencia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Belda', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Hospital Clínico Universitario, Instituto de Investigación Sanitaria-INCLIVA, Valencia, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Soro', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Hospital Clínico Universitario, Instituto de Investigación Sanitaria-INCLIVA, Valencia, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'García-Del-Olmo', 'Affiliation': 'Department of Thoracic Surgery, Consorcio Hospital General Universitario, Valencia, Spain.'}]",General thoracic and cardiovascular surgery,['10.1007/s11748-021-01690-6']
689,34381303,Deepening the Group Training Experience: Group Cohesion and Supervision Impact in Alliance-Focused Training.,"Objective


The aim of the current study is to explore experiences of trainees engaged in alliance-focused training (AFT), a group supervision modality with an explicit focus on awareness of ruptures and implementation of repair strategies. Using Cognitive Behavioral Therapy (CBT) group supervision as a point of comparison, the study examines supervisory alliance, ruptures, group cohesion and safety, and supervision impact.
Method


Eighty-three trainees (clinical psychology interns, advanced-level psychology externs and psychiatry residents) at a metropolitan medical center in New York City who received supervision in CBT (N = 38) or AFT (N = 45) reported on their group supervision experience. Participants had a mean age of 29.5 ( SD =  4.9); 77% were women; 84% of participants identified as White, 7% as Multiethnic, 6% as Hispanic/Latinx, 1% as Black, and 1% as Asian. Participants reported on occurrence of ruptures with their supervisor, supervisory alliance (Working Alliance Inventory-Short), group safety, supervision depth and smoothness (Session Evaluation Questionnaire), and group cohesion (Group Climate Questionnaire). Mixed and general linear models, and correlation analyses were used for analysis.
Results


All trainees reported equally low incidence of ruptures with their supervisor alongside high ratings of supervisory alliance. Trainees in AFT reported experiencing less safety, smoothness, and greater intergroup conflict than trainees in CBT supervision; however, they also reported stronger group engagement and a deeper supervision experience.
Conclusions


Results suggest that AFT may provide a rich environment to foster a certain level of discomfort and risk-taking that may facilitate an engaging and meaningful learning experience.",2021,"Trainees in AFT reported experiencing less safety, smoothness, and greater intergroup conflict than trainees in CBT supervision; however, they also reported stronger group engagement and a deeper supervision experience.
","['Method\n\n\nEighty-three trainees (clinical psychology interns, advanced-level psychology externs and psychiatry residents) at a metropolitan medical center in New York City who received supervision in CBT (N = 38) or AFT (N = 45', 'Participants had a mean age of 29.5 ( SD =  4.9); 77% were women; 84% of participants identified as White, 7% as Multiethnic, 6% as Hispanic/Latinx, 1% as Black, and 1% as Asian']","['trainees engaged in alliance-focused training (AFT', 'Cohesion and Supervision Impact in Alliance-Focused Training', 'AFT', 'Cognitive Behavioral Therapy (CBT']","['occurrence of ruptures with their supervisor, supervisory alliance (Working Alliance Inventory-Short), group safety, supervision depth and smoothness (Session Evaluation Questionnaire), and group cohesion (Group Climate Questionnaire']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0033912', 'cui_str': 'Clinical Psychology'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008946', 'cui_str': 'Climate'}]",,0.038987,"Trainees in AFT reported experiencing less safety, smoothness, and greater intergroup conflict than trainees in CBT supervision; however, they also reported stronger group engagement and a deeper supervision experience.
","[{'ForeName': 'Adelya A', 'Initials': 'AA', 'LastName': 'Urmanche', 'Affiliation': 'Derner School of Psychology, Adelphi University, Hy Weinberg Center, 158 Cambridge Avenue, Garden City, NY 11530, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Minges', 'Affiliation': 'Brief Psychotherapy Research Program, Mount Sinai Beth Israel, 10 Nathan D. Perlman Place, New York, NY 10003.'}, {'ForeName': 'Catherine F', 'Initials': 'CF', 'LastName': 'Eubanks', 'Affiliation': 'Ferkauf Graduate School in Psychology, Yeshiva University, 1165 Morris Park Avenue, Bronx, NY 10461, USA.'}, {'ForeName': 'Bernard S', 'Initials': 'BS', 'LastName': 'Gorman', 'Affiliation': 'Derner School of Psychology, Adelphi University, Hy Weinberg Center, 158 Cambridge Avenue, Garden City, NY 11530, USA.'}, {'ForeName': 'J Christopher', 'Initials': 'JC', 'LastName': 'Muran', 'Affiliation': 'Derner School of Psychology, Adelphi University, Hy Weinberg Center, 158 Cambridge Avenue, Garden City, NY 11530, USA.'}]","Group dynamics : theory, research, and practice : the official journal of Division 49, Group Psychology and Group Psychotherapy of the American Psychological Association",['10.1037/gdn0000134']
690,34383903,"Pecan-Enriched Diets Alter Cholesterol Profiles and Triglycerides in Adults at Risk for Cardiovascular Disease in a Randomized, Controlled Trial.","BACKGROUND


Research indicates that tree nuts are cardioprotective, but studies on pecans are limited.
OBJECTIVES


We examined the impact of daily pecan consumption on blood lipids and glycemia in adults at-risk for cardiovascular disease (CVD).
METHODS


This was a randomized, controlled trial where 56 adults (BMI ≥28 kg/m2 or hypercholesterolemia) were randomly allocated into a control group (n = 18) or 1 of 2 pecan groups. The ADD group (n = 16) consumed pecans (68 g) as part of a free-living diet. The SUB group (n = 18) substituted the pecans (68 g) for isocaloric foods from their diet. At baseline and 8 wk, a high-fat meal was consumed with 4-h postprandial blood draws to determine changes in blood lipids and glycemia.
RESULTS


There was a significant reduction from baseline to 8 wk in fasting total cholesterol (TC) (204 ± 8.76 to 195 ± 8.12; 205 ± 8.06 to 195 ± 6.94 mg/dL), LDL cholesterol (143 ± 8.09 to 129 ± 7.71; 144 ± 6.60 to 135 ± 6.16 mg/dL), triglycerides (TGs) (139 ± 12.1 to 125 ± 14.6; 133 ± 10.7 to 120 ± 10.3 mg/dL), TC/HDL cholesterol ratio (3.92 ± 0.206 to 3.58 ± 0.175; 4.08 ± 0.167 to 3.79 ± 0.151), non-HDL cholesterol (151 ± 8.24 to 140 ± 7.95; 155 ± 6.87 to 143 ± 6.00 mg/dL), and apolipoprotein B (99.1 ± 5.96 to 93.0 ± 5.35; 104 ± 3.43 to 97.1 ± 3.11 mg/dL) in the ADD and SUB groups, respectively (P ≤ 0.05 for all), with no changes in control. There was a reduction in postprandial TGs (P ≤ 0.01) in ADD, and a reduction in postprandial glucose (P < 0.05) in SUB.
CONCLUSIONS


Pecan consumption improves fasting and postprandial blood lipids in CVD at-risk adults. This trial was registered at clinicaltrials.gov as NCT04376632.",2021,"There was a reduction in postprandial TGs (P ≤ 0.01) in ADD, and a reduction in postprandial glucose (P < 0.05) in SUB.
","['Adults at Risk for Cardiovascular Disease', 'adults at-risk for cardiovascular disease (CVD', '56 adults (BMI ≥28\xa0kg/m2 or hypercholesterolemia', 'CVD at-risk adults']","['Pecan-Enriched Diets', 'daily pecan consumption', 'Pecan consumption']","['TC/HDL cholesterol ratio', 'blood lipids and glycemia', 'non-HDL cholesterol', 'LDL cholesterol', 'fasting and postprandial blood lipids', 'postprandial TGs', 'apolipoprotein B', 'postprandial glucose', 'fasting total cholesterol (TC']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}]","[{'cui': 'C0946601', 'cui_str': 'Carya illinoinensis'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",56.0,0.407432,"There was a reduction in postprandial TGs (P ≤ 0.01) in ADD, and a reduction in postprandial glucose (P < 0.05) in SUB.
","[{'ForeName': 'Liana L', 'Initials': 'LL', 'LastName': 'Guarneiri', 'Affiliation': 'Department of Nutritional Sciences, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Chad M', 'Initials': 'CM', 'LastName': 'Paton', 'Affiliation': 'Department of Nutritional Sciences, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Jamie A', 'Initials': 'JA', 'LastName': 'Cooper', 'Affiliation': 'Department of Nutritional Sciences, University of Georgia, Athens, GA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxab248']
691,34386838,Changes in family involvement occasioned by FAMS mobile health intervention mediate changes in glycemic control over 12 months.,"Mobile phone-delivered interventions have proven effective in improving glycemic control (HbA1c) in the short term among adults with type 2 diabetes (T2D). Family systems theory suggests engaging family/friend in adults' diabetes self-care may enhance or sustain improvements. In secondary analysis from a randomized controlled trial (N = 506), we examined intervention effects on HbA1c via change in diabetes-specific helpful and harmful family/friend involvement. We compared a text messaging intervention that did not target family/friend involvement (REACH), REACH plus family-focused intervention components targeting helpful and harmful family/friend involvement (REACH + FAMS), and a control condition. Over 6 months, both intervention groups experienced improvement in HbA1c relative to control, but at 12 months neither did. However, REACH + FAMS showed an indirect effect on HbA1c via change in helpful family/friend involvement at both 6 and 12 months while REACH effects were not mediated by family/friend involvement. Consistent with family systems theory, improvements in HbA1c mediated by improved family/friend involvement were sustained.",2022,Mobile phone-delivered interventions have proven effective in improving glycemic control (HbA1c) in the short term among adults with type 2 diabetes (T2D).,['adults with type 2 diabetes (T2D'],"['text messaging intervention that did not target family/friend involvement (REACH), REACH plus family-focused intervention components targeting helpful and harmful family/friend involvement (REACH\u2009+\u2009FAMS', 'Mobile phone-delivered interventions']","['HbA1c relative', 'glycemic control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0060056', 'cui_str': 'FAM protocol'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0620148,Mobile phone-delivered interventions have proven effective in improving glycemic control (HbA1c) in the short term among adults with type 2 diabetes (T2D).,"[{'ForeName': 'McKenzie K', 'Initials': 'MK', 'LastName': 'Roddy', 'Affiliation': 'Quality Scholars Program, VA Tennessee Valley Healthcare System, US Department of Veteran Affairs, Nashville, TN, USA.'}, {'ForeName': 'Lyndsay A', 'Initials': 'LA', 'LastName': 'Nelson', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Greevy', 'Affiliation': 'Deparment of Biostatistics, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Lindsay S', 'Initials': 'LS', 'LastName': 'Mayberry', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. Lindsay.mayberry@vumc.org.'}]",Journal of behavioral medicine,['10.1007/s10865-021-00250-w']
692,34371137,Completion of Patient-Reported Outcome Questionnaires Among Older Adults with Advanced Cancer.,"CONTEXT


Systematic collection of patient-reported outcomes (PROs) reduces symptom burden and improves quality of life. The ability of older adults to complete PROs, however, has not been thoroughly studied.
OBJECTIVES


To determine whether older adults with advanced cancer received assistance completing PROs, the nature of the assistance, the factors associated with receiving assistance, and how the prevalence of assistance changed over time.
METHODS


Data were obtained from a multisite cluster randomized controlled study of geriatric assessment (Clinicaltrials.gov: NCT02107443). Adults ≥70 years with advanced cancer completed multiple PROs at 4 time points (enrollment, 6 weeks, 3 months, 6 months). Factors associated with receipt of assistance were assessed with bivariate and multivariate analyses.
RESULTS


The study included 541 adults (range 70-96 years, 49% female, mixed incurable cancer diagnoses). Twenty-eight percent (153/541) received assistance completing PROs. Of these, 42% received assistance from caregivers, 37% from research staff, and 15% from both. Factors associated with receiving assistance included older age [Adjusted Odds Ratio (AOR) 3.71, 95% Confidence Interval (CI) 1.03-13.38], lower education level (3.92, 2.11-7.29), impaired cognition (1.90, 1.23-2.93), impaired functional status (2.16, 1.33-3.52), and impaired hearing (1.38, 1.05-1.80). Eighty percent of individuals who received assistance were identified at study initiation. Receiving assistance decreased over time from 28% to 18%, partially due to drop-outs.
CONCLUSION


Over a quarter of older adults with advanced cancer in this study received assistance completing PROs. Completing PROs is a key aspect of many clinical programs and cancer trials; assistance in completing PROs should be offered and provided.",2022,"Factors associated with receiving assistance included older age [Adjusted Odds Ratio (AOR) 3.71, 95% Confidence Interval (CI) 1.03-13.38], lower education level (3.92, 2.11-7.29), impaired cognition (1.90, 1.23-2.93), impaired functional status (2.16, 1.33-3.52), and impaired hearing (1.38, 1.05-1.80).","['Older Adults with Advanced Cancer', 'Adults ≥70 years with advanced cancer', '541 adults (range 70-96 years, 49% female, mixed incurable cancer diagnoses', 'older adults with advanced cancer', 'older adults']",['assistance completing PROs'],"['impaired hearing', 'lower education level', 'impaired functional status', 'impaired cognition', 'quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]","[{'cui': 'C0260662', 'cui_str': 'Hearing problem'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",541.0,0.256423,"Factors associated with receiving assistance included older age [Adjusted Odds Ratio (AOR) 3.71, 95% Confidence Interval (CI) 1.03-13.38], lower education level (3.92, 2.11-7.29), impaired cognition (1.90, 1.23-2.93), impaired functional status (2.16, 1.33-3.52), and impaired hearing (1.38, 1.05-1.80).","[{'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Flannery', 'Affiliation': 'School of Nursing (M.A.F., S.N.), University of Rochester School of Medicine and Dentistry, Rochester, New York, USA. Electronic address: marie_flannery@urmc.rochester.edu.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Mohile', 'Affiliation': 'University of Rochester School of Medicine and Dentistry (S.M., E.C., C.K., G.D., K.P.L.), Rochester, New York, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'University of Rochester School of Medicine and Dentistry (S.M., E.C., C.K., G.D., K.P.L.), Rochester, New York, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Norton', 'Affiliation': 'School of Nursing (M.A.F., S.N.), University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kamen', 'Affiliation': 'University of Rochester School of Medicine and Dentistry (S.M., E.C., C.K., G.D., K.P.L.), Rochester, New York, USA.'}, {'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'University of Alabama (J.N.D.-O.), Birmingham, School of Nursing, Birmingham, Alabama, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'DiGiovanni', 'Affiliation': 'University of Rochester School of Medicine and Dentistry (S.M., E.C., C.K., G.D., K.P.L.), Rochester, New York, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Griggs', 'Affiliation': 'University of Rochester Medical Center (L.G.), SCOREBOARD, Patient Advisory Board, Rochester, New York, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bradley', 'Affiliation': 'Northwell Health NCORP (T.B.), New York, New York, USA.'}, {'ForeName': 'Judith O', 'Initials': 'JO', 'LastName': 'Hopkins', 'Affiliation': 'Southeast Clinical Oncology Research Consortium NCORP (J.O.H.), Winston Salem, North Carolina, USA.'}, {'ForeName': 'Jane Jijun', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'Illinois Cancer Care and Heartland NCORP (J.J.L.), Illnois, USA.'}, {'ForeName': 'Kah Poh', 'Initials': 'KP', 'LastName': 'Loh', 'Affiliation': 'University of Rochester School of Medicine and Dentistry (S.M., E.C., C.K., G.D., K.P.L.), Rochester, New York, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2021.07.032']
693,34375748,Multilevel Follow-up of Cancer Screening (mFOCUS): Protocol for a multilevel intervention to improve the follow-up of abnormal cancer screening test results.,"INTRODUCTION


While substantial attention is focused on the delivery of routine preventive cancer screening, less attention has been paid to systematically ensuring that there is timely follow-up of abnormal screening test results. Barriers to completion of timely follow-up occur at the patient, provider, care team and system levels.
METHODS


In this pragmatic cluster randomized controlled trial, primary care sites in three networks are randomized to one of four arms: (1) standard care, (2) ""visit-based"" reminders that appear in a patient's electronic health record (EHR) when it is accessed by either patient or providers (3) visit based reminders with population health outreach, and (4) visit based reminders, population health outreach, and patient navigation with systematic screening and referral to address social barriers to care. Eligible patients in participating practices are those overdue for follow-up of an abnormal results on breast, cervical, colorectal and lung cancer screening tests.
RESULTS


The primary outcome is whether an individual receives follow-up, specific to the organ type and screening abnormality, within 120 days of becoming eligible for the trial. Secondary outcomes assess the effect of intervention components on the patient and provider experience of obtaining follow-up care and the delivery of the intervention components.
CONCLUSIONS


This trial will provide evidence for the role of a multilevel intervention on improving the follow-up of abnormal cancer screening test results. We will also specifically assess the relative impact of the components of the intervention, compared to standard care.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03979495.",2021,"The primary outcome is whether an individual receives follow-up, specific to the organ type and screening abnormality, within 120 days of becoming eligible for the trial.","['Eligible patients in participating practices are those overdue for follow-up of an abnormal results on breast, cervical, colorectal and lung cancer screening tests']","['standard care, (2) ""visit-based"" reminders that appear in a patient\'s electronic health record (EHR) when it is accessed by either patient or providers (3) visit based reminders with population health outreach, and (4) visit based reminders, population health outreach, and patient navigation with systematic screening and referral to address social barriers to care']","['effect of intervention components on the patient and provider experience of obtaining follow-up care and the delivery of the intervention components', 'individual receives follow-up, specific to the organ type and screening abnormality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0459424', 'cui_str': 'Abnormal result'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3242284', 'cui_str': 'Population Health'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C3899107', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",,0.299859,"The primary outcome is whether an individual receives follow-up, specific to the organ type and screening abnormality, within 120 days of becoming eligible for the trial.","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: Jennifer.Haas@mgh.harvard.edu.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Atlas', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Aman', 'Affiliation': 'Information, Technology and Consulting (ITC), Dartmouth College, Lebanon, NH.'}, {'ForeName': 'Erica S', 'Initials': 'ES', 'LastName': 'Breslau', 'Affiliation': 'Division of Cancer Prevention and Control, National Cancer Institute, Rockville, MD, USA.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Burdick', 'Affiliation': 'Department of Community and Family Medicine, Dartmouth-Hitchcock Health, Lebanon, NH; The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine, Hanover, NH, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Carpenter', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Chang', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Tin', 'Initials': 'T', 'LastName': 'Dang', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Courtney J', 'Initials': 'CJ', 'LastName': 'Diamond', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Feldman', 'Affiliation': ""Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Harris', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Shoshana J', 'Initials': 'SJ', 'LastName': 'Hort', 'Affiliation': 'Department of Medicine, Dartmouth-Hitchcock Health, Lebanon, NH, USA.'}, {'ForeName': 'Molly L', 'Initials': 'ML', 'LastName': 'Housman', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine, Hanover, NH, USA.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Mecker', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Constance D', 'Initials': 'CD', 'LastName': 'Lehman', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Percac-Lima', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine, Hanover, NH, USA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Wint', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Anna N A', 'Initials': 'ANA', 'LastName': 'Tosteson', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine, Hanover, NH, USA; Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center and Geisel School of Medicine at Dartmouth, Lebanon, NH, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106533']
694,34377934,MAF  Amplification and Adjuvant Clodronate Outcomes in Early-Stage Breast Cancer in NSABP B-34 and Potential Impact on Clinical Practice.,"Background


The Adjuvant Zoledronic Acid (ZA) study in early breast cancer (AZURE) showed correlation between a nonamplified  MAF  gene in the primary tumor and benefit from adjuvant ZA. Adverse ZA outcomes occurred in MAF-amplified patients. NSABP B-34 is a validation study.
Methods


A retrospective analysis of  MAF  gene status in NSABP B-34 was performed. Eligible patients were randomly assigned to standard adjuvant systemic treatment plus 3 years oral clodronate (1600 mg/daily) or placebo. Tumors were tested for  MAF  gene amplification and analyzed for their relationship to clodronate for disease-free survival (DFS) and overall survival (OS) in  MAF  nonamplified patients. All statistical tests were 2-sided .
Results


MAF  status was assessed in 2533 available primary tumor samples from 3311 patients. Of these, 37 withdrew consent; in 77 samples, no tumor was found; 536 assays did not meet quality standards, leaving 1883 (77.8%) evaluable for  MAF  assay by fluorescence in situ hybridization (947 from placebo and 936 from clodronate arms). At 5 years, in  MAF  nonamplified patients receiving clodronate, DFS improved by 30% (hazard ratio = 0.70, 95% confidence interval = 0.51 to 0.94;  P  =   .02). OS improved at 5 years (hazard ratio = 0.59, 95% confidence interval = 0.37 to 0.93;  P  =   .02) remaining statistically significant for clodronate throughout study follow-up. Conversely, adjuvant clodronate in women with  MAF -amplified tumors was not associated with benefit but rather possible harm in some subgroups. Association between MAF status and menopausal status was not seen.
Conclusions


Nonamplified  MAF  showed statistically significant benefits (DFS and OS) with oral clodronate, supporting validation of the AZURE study.",2021,"OS improved at 5 years (hazard ratio = 0.59, 95% confidence interval = 0.37 to 0.93;  P  =   .02) remaining statistically significant for clodronate throughout study follow-up.","['women with  MAF', 'early breast cancer (AZURE', '2533 available primary tumor samples from 3311 patients', 'Eligible patients']","['oral clodronate', 'Zoledronic Acid (ZA', 'standard adjuvant systemic treatment plus 3 years oral clodronate', 'clodronate', 'placebo', 'adjuvant clodronate']","['Adverse ZA outcomes', 'disease-free survival (DFS) and overall survival (OS', 'OS', 'MAF status and menopausal status']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0079786', 'cui_str': 'Macrophage activating factor'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0162357', 'cui_str': 'Clodronate'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0079786', 'cui_str': 'Macrophage activating factor'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]",3311.0,0.389442,"OS improved at 5 years (hazard ratio = 0.59, 95% confidence interval = 0.37 to 0.93;  P  =   .02) remaining statistically significant for clodronate throughout study follow-up.","[{'ForeName': 'Alexander H G', 'Initials': 'AHG', 'LastName': 'Paterson', 'Affiliation': 'NSABP Foundation and NRG Oncology, Pittsburgh, PA, USA.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Lucas', 'Affiliation': 'NSABP Foundation and NRG Oncology, Pittsburgh, PA, USA.'}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Anderson', 'Affiliation': 'NSABP Foundation and NRG Oncology, Pittsburgh, PA, USA.'}, {'ForeName': 'Eleftherios P', 'Initials': 'EP', 'LastName': 'Mamounas', 'Affiliation': 'NSABP Foundation and NRG Oncology, Pittsburgh, PA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Brufsky', 'Affiliation': 'NSABP Foundation and NRG Oncology, Pittsburgh, PA, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Baez-Diaz', 'Affiliation': 'NSABP Foundation and NRG Oncology, Pittsburgh, PA, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'King', 'Affiliation': 'NSABP Foundation and NRG Oncology, Pittsburgh, PA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lad', 'Affiliation': 'NSABP Foundation and NRG Oncology, Pittsburgh, PA, USA.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Robidoux', 'Affiliation': 'NSABP Foundation and NRG Oncology, Pittsburgh, PA, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Finnigan', 'Affiliation': 'NSABP Foundation and NRG Oncology, Pittsburgh, PA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Sampayo', 'Affiliation': 'Syntax for Science SL, Palma de Mallorca, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Tercero', 'Affiliation': 'Inbiomotion SL, Barcelona, Spain.'}, {'ForeName': 'Joël Jean', 'Initials': 'JJ', 'LastName': 'Mairet', 'Affiliation': 'Inbiomotion SL, Barcelona, Spain.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'NSABP Foundation and NRG Oncology, Pittsburgh, PA, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fehrenbacher', 'Affiliation': 'NSABP Foundation and NRG Oncology, Pittsburgh, PA, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NSABP Foundation and NRG Oncology, Pittsburgh, PA, USA.'}, {'ForeName': 'Roger R', 'Initials': 'RR', 'LastName': 'Gomis', 'Affiliation': 'Cancer Science, Institute for Research in Biomedicine (IRB Barcelona), The Barcelona Institute of Science and Technology, Barcelona, Spain.'}]",JNCI cancer spectrum,['10.1093/jncics/pkab054']
695,34379802,High-dose pollen intralymphatic immunotherapy: Two RDBPC trials question the benefit of dose increase.,"BACKGROUND


The same dosing schedule, 1000 SQ-U times three, with one-month intervals, have been evaluated in most trials of intralymphatic immunotherapy (ILIT) for the treatment of allergic rhinitis (AR). The present studies evaluated if a dose escalation in ILIT can enhance the clinical and immunological effects, without compromising safety.
METHODS


Two randomized double-blind placebo-controlled trials of ILIT for grass pollen-induced AR were performed. The first included 29 patients that had recently ended 3 years of SCIT and the second contained 39 not previously vaccinated patients. An up-dosage of 1000-3000-10,000 (5000 + 5000 with 30 minutes apart) SQ-U with 1 month in between was evaluated.
RESULTS


Doses up to 10,000 SQ-U were safe after recent SCIT. The combined symptom-medication scores (CSMS) were reduced by 31% and the grass-specific IgG4 levels in blood were doubled. In ILIT de novo, the two first patients that received active treatment developed serious adverse reactions at 5000 SQ-U. A modified up-dosing schedule; 1000-3000-3000 SQ-U appeared to be safe but failed to improve the CSMS. Flow cytometry analyses showed increased activation of lymph node-derived dendritic but not T cells. Quality of life and nasal provocation response did not improve in any study.
CONCLUSION


Intralymphatic immunotherapy in high doses after SCIT appears to further reduce grass pollen-induced seasonal symptoms and may be considered as an add-on treatment for patients that do not reach full symptom control after SCIT. Up-dosing schedules de novo with three monthly injections that exceeds 3000 SQ-U should be avoided.",2022,The combined symptom-medication scores (CSMS) were reduced by 31% and the grass specific IgG4 levels in blood were doubled.,['29 patients that had recently ended 3 years of SCIT and the second contained 39 not previously vaccinated patients'],"['placebo', 'ILIT', 'intralymphatic immunotherapy (ILIT']","['combined symptom-medication scores (CSMS', 'Quality of life and nasal provocation response', 'serious adverse reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1512956', 'cui_str': 'Intralymphatic route'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0449428', 'cui_str': 'Provocation'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",10000.0,0.112489,The combined symptom-medication scores (CSMS) were reduced by 31% and the grass specific IgG4 levels in blood were doubled.,"[{'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Hellkvist', 'Affiliation': 'Division of ENT Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hjalmarsson', 'Affiliation': 'Division of ENT Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Weinfeld', 'Affiliation': 'Asthma and Allergy Clinic Outpatient Unit (adults), Department of Internal Medicine, South Alvsborgs Central Hospital, Boras, Sweden.'}, {'ForeName': 'Åslög', 'Initials': 'Å', 'LastName': 'Dahl', 'Affiliation': 'Departments of Biological and Environmental Sciences, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Karlsson', 'Affiliation': 'Division of ENT Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Westman', 'Affiliation': 'Immunology and Allergy Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Lundkvist', 'Affiliation': 'Division of ENT Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Winqvist', 'Affiliation': 'ABC Labs, Biomedicum, Stockholm, Sweden.'}, {'ForeName': 'Susanna Kumlien', 'Initials': 'SK', 'LastName': 'Georén', 'Affiliation': 'Division of ENT Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Westin', 'Affiliation': 'Laboratory of Clinical and Experimental Allergy Research, Department of Otorhinolaryngology Malmö, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Lars Olaf', 'Initials': 'LO', 'LastName': 'Cardell', 'Affiliation': 'Division of ENT Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}]",Allergy,['10.1111/all.15042']
696,34384042,Comparing Smoking Cessation Interventions among Underserved Patients Referred for Lung Cancer Screening: A Pragmatic Trial Protocol.,"Smoking burdens are greatest among underserved patients. Lung cancer screening (LCS) reduces mortality among individuals at risk for smoking-associated lung cancer. Although LCS programs must offer smoking cessation support, the interventions that best promote cessation among underserved patients in this setting are unknown. This stakeholder-engaged, pragmatic randomized clinical trial will compare the effectiveness of four interventions promoting smoking cessation among underserved patients referred for LCS. By using an additive study design, all four arms provide standard ""ask-advise-refer"" care. Arm 2 adds free or subsidized pharmacologic cessation aids, arm 3 adds financial incentives up to $600 for cessation, and arm 4 adds a mobile device-delivered episodic future thinking tool to promote attention to long-term health goals. We hypothesize that smoking abstinence rates will be higher with the addition of each intervention when compared with arm 1. We will enroll 3,200 adults with LCS orders at four U.S. health systems. Eligible patients include those who smoke at least one cigarette daily and self-identify as a member of an underserved group (i.e., is Black or Latinx, is a rural resident, completed a high school education or less, and/or has a household income <200% of the federal poverty line). The primary outcome is biochemically confirmed smoking abstinence sustained through 6 months. Secondary outcomes include abstinence sustained through 12 months, other smoking-related clinical outcomes, and patient-reported outcomes. This pragmatic randomized clinical trial will identify the most effective smoking cessation strategies that LCS programs can implement to reduce smoking burdens affecting underserved populations. Clinical trial registered with clinicaltrials.gov (NCT04798664). Date of registration: March 12, 2021. Date of trial launch: May 17, 2021.",2022,"This stakeholder-engaged, pragmatic randomized clinical trial (RCT) will compare the effectiveness of four interventions promoting smoking cessation among underserved patients referred for LCS.","['Eligible patients include those who smoke at least one cigarette daily and self-identify as a member of an underserved group (i.e., Black or Latinx, a rural resident, completed a high school education or less, and/or with a household income <200% of the federal poverty line', 'Underserved Patients Referred for Lung Cancer Screening', 'individuals at risk for smoking-associated lung cancer', 'underserved patients referred for LCS', 'underserved patients', '3,200 adults with LCS orders at four United States health systems']","['Smoking Cessation Interventions', 'Lung cancer screening (LCS']","['Smoking burdens', 'smoking abstinence rates', 'abstinence sustained through 12 months, other smoking-related clinical outcomes, and patient-reported outcomes', 'smoking abstinence sustained through 6 months']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",3200.0,0.0912829,"This stakeholder-engaged, pragmatic randomized clinical trial (RCT) will compare the effectiveness of four interventions promoting smoking cessation among underserved patients referred for LCS.","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kohn', 'Affiliation': 'Palliative and Advanced Illness Research Center.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Vachani', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Small', 'Affiliation': 'Department of Statistics, The Wharton School, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alisa J', 'Initials': 'AJ', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Sheu', 'Affiliation': 'Palliative and Advanced Illness Research Center.'}, {'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Madden', 'Affiliation': 'Palliative and Advanced Illness Research Center.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bayes', 'Affiliation': 'Palliative and Advanced Illness Research Center.'}, {'ForeName': 'Marzana', 'Initials': 'M', 'LastName': 'Chowdhury', 'Affiliation': 'Palliative and Advanced Illness Research Center.'}, {'ForeName': 'Sadie', 'Initials': 'S', 'LastName': 'Friday', 'Affiliation': 'Palliative and Advanced Illness Research Center.'}, {'ForeName': 'Jannie', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Palliative and Advanced Illness Research Center.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Gould', 'Affiliation': 'Department of Health Systems Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, California.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Ismail', 'Affiliation': 'Department of Preventive Medicine and.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Creekmur', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Riverside, California.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Facktor', 'Affiliation': 'Department of Thoracic Surgery, Geisinger Heart Institute.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Collins', 'Affiliation': 'Department of Psychiatry, and.'}, {'ForeName': 'Kristina K', 'Initials': 'KK', 'LastName': 'Blessing', 'Affiliation': 'Investigator Initiated Research Operations, Geisinger Health System, Danville, Pennsylvania.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Neslund-Dudas', 'Affiliation': 'Department of Public Health Sciences.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Simoff', 'Affiliation': 'Henry Ford Cancer Institute, and.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Alleman', 'Affiliation': 'Department of Public Health Sciences.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Horst', 'Affiliation': 'Lancaster General Health Research Institute, University of Pennsylvania Health System, Lancaster, Pennsylvania.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Scott', 'Affiliation': 'The Center for Black Health and Equity, Durham, North Carolina; and.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Halpern', 'Affiliation': 'Palliative and Advanced Illness Research Center.'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Hart', 'Affiliation': 'Palliative and Advanced Illness Research Center.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202104-499SD']
697,34384000,"Bioequivalence Assessment of an Oral Fixed-Dose Formulation of Dutasteride-Tamsulosin 0.5 mg/0.4 mg: A Randomized, Single-Blind, Single-Dose, 2-Period Crossover Study in Mexican Population Under Fasted Conditions.","The aim of the present study was to compare the bioavailability and to demonstrate the bioequivalence between a dutasteride-tamsulosin 0.5 mg/0.4 mg capsule formulation and the regulatory reference drug (Combodart®, GlaxoSmithKline). A randomized, single-blind, single-dose, 2-way crossover study under fasting conditions, with at least a 28-day washout period was carried out in healthy volunteers. Plasma concentrations of drugs were determined by high-performance liquid chromatography-tandem mass spectrometry. The pharmacokinetic analysis included maximum plasma concentration (C max  ), area under the plasma concentration-time curve (AUC) from time 0 to 72 hours, and AUC from baseline to infinity. The test formulation was considered bioequivalent if the geometric mean ratios (test/reference) were within the predetermined range of 80% to 125%. Safety and tolerability were evaluated by clinical assessment. The confidence intervals for the log-transformed test/reference ratios for dutasteride, C max  (95.4-109.2) and AUC from baseline to 72 hours (93.2-109.1), and for tamsulosin, C max  (101.9-119.8), AUC from baseline to the last quantifiable concentration (91.4-106.3) and AUC from baseline to infinity (90.9-103.3), were within the allowed limit specified by the regulatory authorities (80%-125%). In addition, both test and reference drugs were safe and tolerated. These results demonstrated the bioequivalence of test product (Dakart®) compared with Combodart®.",2022,These results demonstrated the bioequivalence of test product (Dakart®) compared with Combodart®.,"['healthy volunteers', 'Mexican Population Under Fasted Conditions']","['Dutasteride-Tamsulosin', 'dutasteride-tamsulosin']","['safe and tolerated', 'bioavailability', 'Safety and tolerability', 'maximum plasma concentration (C max  ), area under the plasma concentration-time curve (AUC) from time 0 to 72 hours, and AUC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C2926870', 'cui_str': 'tamsulosin and dutasteride'}]","[{'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.095281,These results demonstrated the bioequivalence of test product (Dakart®) compared with Combodart®.,"[{'ForeName': 'Everardo', 'Initials': 'E', 'LastName': 'Piñeyro-Garza', 'Affiliation': 'Ipharma, S.A. de C.V., Colonia Mitras Centro, Monterrey, Nuevo León, México.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Gómez-Silva', 'Affiliation': 'Ipharma, S.A. de C.V., Colonia Mitras Centro, Monterrey, Nuevo León, México.'}, {'ForeName': 'María E', 'Initials': 'ME', 'LastName': 'Gamino', 'Affiliation': 'Ipharma, S.A. de C.V., Colonia Mitras Centro, Monterrey, Nuevo León, México.'}, {'ForeName': 'Livan', 'Initials': 'L', 'LastName': 'Delgado-Roche', 'Affiliation': 'Laboratorios Liomont, S.A. de C.V., Colonia Cuajimalpa, Cuajimalpa de Morelos, Ciudad de México, México.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.1011']
698,33831843,Effect of Warm-Up and Sodium Bicarbonate Ingestion on 4-km Cycling Time-Trial Performance.,"PURPOSE


To examine whether an ecologically valid, intermittent, sprint-based warm-up strategy impacted the ergogenic capacity of individualized sodium bicarbonate (NaHCO3) ingestion on 4-km cycling time-trial (TT) performance.
METHODS


A total of 8 male cyclists attended 6 laboratory visits for familiarization, determination of time to peak blood bicarbonate, and 4 × 4-km cycling TTs. Experimental beverages were administered doubleblind. Treatments were conducted in a block-randomized, crossover order: intermittent warm-up + NaHCO3 (IWSB), intermittent warm-up + placebo, control warm-up + NaHCO3 (CWSB), and control warm-up + placebo (CWP). The intermittent warm-up comprised exercise corresponding to lactate threshold (5 min at 50%, 2 min at 60%, 2 min at 80%, 1 min at 100%, and 2 min at 50%) and 3 × 10-second maximal sprints. The control warm-up comprised 16.5 minutes cycling at 150 W. Participants ingested 0.3 g·kg body mass-1 NaHCO3 or 0.03 g·kg body mass-1 sodium chloride (placebo) in 5 mL·kg body mass-1 fluid (3:2, water and sugar-free orange squash). Paired t tests were conducted for TT performance. Hematological data (blood bicarbonate and blood lactate) and gastrointestinal discomfort were analyzed using repeated-measures analysis of variance.
RESULTS


Performance was faster for CWSB versus IWSB (5.0 [6.1] s; P = .052) and CWP (5.8 [6.0] s; P = .03). Pre-TT bicarbonate concentration was elevated for CWSB versus IWSB (+9.3 mmol·L-1; P < .001) and CWP (+7.1 mmol·L-1; P < .001). Post-TT blood lactate concentration was elevated for CWSB versus CWP (+2.52 mmol·L-1; P = .022). Belching was exacerbated pre-warm-up for IWSB versus intermittent warm-up +placebo (P = .046) and CWP (P = .027).
CONCLUSION


An intermittent, sprint-based warm-up mitigated the ergogenic benefits of NaHCO3 ingestion on 4-km cycling TT performance.",2021,"Belching was exacerbated pre-warm-up for IWSB versus intermittent warm-up +placebo (P = .046) and CWP (P = .027).
CONCLUSION


","['8 male cyclists attended 6 laboratory visits for familiarization, determination of time to peak blood bicarbonate, and 4 × 4-km cycling TTs']","['individualized sodium bicarbonate (NaHCO3) ingestion', 'Warm-Up and Sodium Bicarbonate Ingestion', 'IWSB versus intermittent warm-up +placebo', 'intermittent warm-up comprised exercise corresponding to lactate threshold', 'control warm-up comprised 16.5\xa0minutes cycling at 150\xa0W. Participants ingested 0.3\xa0g·kg body mass-1 NaHCO3 or 0.03\xa0g·kg body mass-1 sodium chloride (placebo', 'intermittent warm-up + NaHCO3 (IWSB), intermittent warm-up + placebo, control warm-up + NaHCO3 (CWSB), and control warm-up + placebo (CWP']","['4-km cycling time-trial (TT) performance', 'Hematological data (blood bicarbonate and blood lactate) and gastrointestinal discomfort', 'Post-TT blood lactate concentration', 'Belching', 'TT bicarbonate concentration', 'CWP']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0853263', 'cui_str': 'Blood bicarbonate'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0853263', 'cui_str': 'Blood bicarbonate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014724', 'cui_str': 'Eructation'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",8.0,0.0891105,"Belching was exacerbated pre-warm-up for IWSB versus intermittent warm-up +placebo (P = .046) and CWP (P = .027).
CONCLUSION


","[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Gurton', 'Affiliation': ''}, {'ForeName': 'Steve H', 'Initials': 'SH', 'LastName': 'Faulkner', 'Affiliation': ''}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'James', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0743']
699,33832998,"Characteristics of Veterans With Non-VA Encounters Enrolled in a Trial of Standards-Based, Interoperable Event Notification and Care Coordination.","INTRODUCTION


Understanding how veterans use Veterans Affairs (VA) for primary care and non-VA for acute care can help policy makers predict future health care resource use. We aimed to describe characteristics of veterans enrolled in a multisite clinical trial of non-VA acute event notifications and care coordination and to identify patient factors associated with non-VA acute care.
METHODS


Characteristics of 565 veterans enrolled in a prospective cluster randomized trial at the Bronx and Indianapolis VA Medical Centers were obtained by interview and chart review.
RESULTS


Veterans' mean age was 75.8 years old, 98.3% were male, and 39.2% self-identified as a minority race; 81.2% reported receiving the majority of care at the VA. There were 197 (34.9%) veterans for whom a non-VA acute care alert was received. Patient characteristics significantly associated with greater odds of a non-VA alert included older age (OR = 1.05; 95% CI, 1.04-1.05); majority of care received is non-VA (OR = 1.83; 95% CI, 1.06-3.15); private insurance (OR = 1.39; 95% CI, 1.19-1.62); and higher income (OR = 4.01; 95% CI, 2.68-5.98).
CONCLUSIONS


We identified several patient-level factors associated with non-VA acute care that can inform the design of VA services and policies for veterans with non-VA acute care encounters and reintegration back into the VA system.",2021,"Patient characteristics significantly associated with greater odds of a non-VA alert included older age (OR = 1.05; 95% CI, 1.04-1.05); majority of care received is non-VA (OR = 1.83; 95% CI, 1.06-3.15); private insurance (OR = 1.39; 95% CI, 1.19-1.62); and higher income (OR = 4.01; 95% CI, 2.68-5.98).
","['Characteristics of 565 veterans enrolled in a prospective cluster randomized trial at the Bronx and Indianapolis VA Medical Centers were obtained by interview and chart review', ""Veterans' mean age was 75.8 years old, 98.3% were male, and 39.2% self-identified as a minority race; 81.2% reported receiving the majority of care at the VA"", 'Veterans With Non-VA Encounters Enrolled in a Trial of Standards']",[],[],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0541653', 'cui_str': 'Chart evaluation by healthcare professional'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],[],565.0,0.107328,"Patient characteristics significantly associated with greater odds of a non-VA alert included older age (OR = 1.05; 95% CI, 1.04-1.05); majority of care received is non-VA (OR = 1.83; 95% CI, 1.06-3.15); private insurance (OR = 1.39; 95% CI, 1.19-1.62); and higher income (OR = 4.01; 95% CI, 2.68-5.98).
","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kartje', 'Affiliation': 'From the Richard L. Roudebush VA Medical Center, U.S. Department of Veterans Affairs, Indianapolis, IN (RK, BED, ALS, JCY); IU Fairbanks School of Public Health, Indianapolis, IN (BED); Regenstrief Institute, Indianapolis, IN (BED): James J. Peters VA Medical Center, U.S. Department of Veterans Affairs, Bronx, NY (VG, KMJ, KB); Icahn School of Medicine at Mount Sinai, New York, NY (KB). rebecca.kartje@va.gov.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Dixon', 'Affiliation': 'From the Richard L. Roudebush VA Medical Center, U.S. Department of Veterans Affairs, Indianapolis, IN (RK, BED, ALS, JCY); IU Fairbanks School of Public Health, Indianapolis, IN (BED); Regenstrief Institute, Indianapolis, IN (BED): James J. Peters VA Medical Center, U.S. Department of Veterans Affairs, Bronx, NY (VG, KMJ, KB); Icahn School of Medicine at Mount Sinai, New York, NY (KB).'}, {'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Schwartzkopf', 'Affiliation': 'From the Richard L. Roudebush VA Medical Center, U.S. Department of Veterans Affairs, Indianapolis, IN (RK, BED, ALS, JCY); IU Fairbanks School of Public Health, Indianapolis, IN (BED); Regenstrief Institute, Indianapolis, IN (BED): James J. Peters VA Medical Center, U.S. Department of Veterans Affairs, Bronx, NY (VG, KMJ, KB); Icahn School of Medicine at Mount Sinai, New York, NY (KB).'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Guerrero', 'Affiliation': 'From the Richard L. Roudebush VA Medical Center, U.S. Department of Veterans Affairs, Indianapolis, IN (RK, BED, ALS, JCY); IU Fairbanks School of Public Health, Indianapolis, IN (BED); Regenstrief Institute, Indianapolis, IN (BED): James J. Peters VA Medical Center, U.S. Department of Veterans Affairs, Bronx, NY (VG, KMJ, KB); Icahn School of Medicine at Mount Sinai, New York, NY (KB).'}, {'ForeName': 'Kimberly M', 'Initials': 'KM', 'LastName': 'Judon', 'Affiliation': 'From the Richard L. Roudebush VA Medical Center, U.S. Department of Veterans Affairs, Indianapolis, IN (RK, BED, ALS, JCY); IU Fairbanks School of Public Health, Indianapolis, IN (BED); Regenstrief Institute, Indianapolis, IN (BED): James J. Peters VA Medical Center, U.S. Department of Veterans Affairs, Bronx, NY (VG, KMJ, KB); Icahn School of Medicine at Mount Sinai, New York, NY (KB).'}, {'ForeName': 'Joanne C', 'Initials': 'JC', 'LastName': 'Yi', 'Affiliation': 'From the Richard L. Roudebush VA Medical Center, U.S. Department of Veterans Affairs, Indianapolis, IN (RK, BED, ALS, JCY); IU Fairbanks School of Public Health, Indianapolis, IN (BED); Regenstrief Institute, Indianapolis, IN (BED): James J. Peters VA Medical Center, U.S. Department of Veterans Affairs, Bronx, NY (VG, KMJ, KB); Icahn School of Medicine at Mount Sinai, New York, NY (KB).'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Boockvar', 'Affiliation': 'From the Richard L. Roudebush VA Medical Center, U.S. Department of Veterans Affairs, Indianapolis, IN (RK, BED, ALS, JCY); IU Fairbanks School of Public Health, Indianapolis, IN (BED); Regenstrief Institute, Indianapolis, IN (BED): James J. Peters VA Medical Center, U.S. Department of Veterans Affairs, Bronx, NY (VG, KMJ, KB); Icahn School of Medicine at Mount Sinai, New York, NY (KB).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2021.02.200251']
700,34382209,"Pharmacokinetic/Pharmacodynamic Analysis of Guselkumab for Treatment of Palmoplantar Pustulosis: Clinical Implications of Guselkumab Dose, Disease Severity, and Smoking in Japanese Patients.","Guselkumab is a human IgG1λ monoclonal antibody that has been approved for treatment of multiple immunologic diseases including palmoplantar pustulosis in Japan. The efficacy of guselkumab in reducing disease severity as compared with placebo has been demonstrated in phase 2 and 3 clinical studies. In some patients assigned to the placebo treatment, worsening of Palmoplantar Pustulosis Area and Severity Index (PPPASI) score was noted. Most of these patients were smokers, raising a possibility of an association of smoking with the disease progression. To understand the clinical implications of guselkumab dose, baseline disease severity, and smoking on the treatment effect and describe the longitudinal relationship between guselkumab exposure and the PPPASI score, a pharmacokinetic/pharmacodynamic modeling analysis was conducted using the pooled data from 1 phase 2 and 1 phase 3 study. Data from 207 Japanese patients (77% women and 60% smokers) with a median PPPASI score of 24.6 were included in the analysis. The observed treatment efficacy (the PPPASI score reduction) appeared to be similar at the current approved dose (100 mg) and the higher dose (200 mg). A greater PPPASI score reduction (in absolute points) is expected in patients with higher baseline PPPASI score (severe disease). However, the higher baseline did not translate to larger magnitude of the change from baseline (in percentage) in the PPPASI score. Incorporating a linear disease progression effect in the model significantly decreased the Nonlinear Mixed Effects Modeling objective function value (P < .001). Smoking status appeared to be related to disease worsening in some patients, but the covariate did not reach statistical significance in the model.",2022,Greater extent of the PPPASI score reduction (in absolute points) is expected in patients with higher baseline PPPASI score (severe disease).,"['Japanese Patients', 'Palmoplantar Pustulosis', '207 Japanese patients (77% women and 60% smokers) with a median PPPASI score of 24.6 were included in the analysis', 'palmoplantar pustulosis (PPP) in Japan']","['Guselkumab', 'placebo', 'guselkumab']","['worsening of PPP Area and Severity Index (PPPASI) score', 'PPPASI score reduction']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030246', 'cui_str': 'Pustular psoriasis of palms and soles'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0031106', 'cui_str': 'Aggressive periodontitis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0031106', 'cui_str': 'Aggressive periodontitis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",207.0,0.164318,Greater extent of the PPPASI score reduction (in absolute points) is expected in patients with higher baseline PPPASI score (severe disease).,"[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Iwaki', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Janssen Pharmaceutical K.K., Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Sayori', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Janssen Pharmaceutical K.K., Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Chuanpu', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1953']
701,33829804,"Intersecting minority statuses and tryptophan degradation among stimulant-using, sexual minority men living with HIV.","BACKGROUND


Disclosure of one's sexual orientation as a sexual-minority (SM) person (i.e., being ""out"") may affect HIV-related health outcomes. This longitudinal study examined whether race/ethnicity moderated effects of outness on the plasma kynurenine/tryptophan (KT) ratio, a marker of dysregulated serotonin metabolism due to immune activation that predicts clinical HIV progression.
METHODS


Participants were African American, Hispanic/Latino, and non-Hispanic White, methamphetamine-using SM men living with HIV (N = 97) who completed self-report scales of outness and SM stress at baseline for a randomized controlled trial of a positive affect intervention. Linear mixed modeling was used to test whether race/ethnicity and experimental condition moderated the association of baseline outness with the KT ratio at baseline, 6, 12, and 15 months controlling for SM stress, sociodemographics, HIV disease markers, and recent stimulant use.
RESULTS


The interactions of outness by race/ethnicity and outness by experimental condition on the KT ratio were significant. Greater outness predicted a lower KT ratio over time in non-Hispanic White SM men, but not among SM men of color (MOC). Greater outness predicted a lower KT ratio over time for SM men in the control, but not among those in the intervention arm.
CONCLUSION


Being more out may be protective for non-Hispanic White SM men, but not for their SM MOC peers. Outness mattered for participants who did not receive the positive affect intervention. Findings underscore the potentially different contexts and consequences of outness depending on SM men's race/ethnicity and whether they received a positive affect intervention. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Greater outness predicted a lower KT ratio over time in non-Hispanic White SM men, but not among SM men of color (MOC).","['Participants were African American, Hispanic/Latino, and non-Hispanic White, methamphetamine-using SM men living with HIV (N = 97) who completed self-report scales of outness and SM stress at baseline for a randomized controlled trial of a positive affect intervention', 'sexual minority men living with HIV']",[],"['plasma kynurenine/tryptophan (KT) ratio', 'KT ratio']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022818', 'cui_str': 'Kynurenine'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.160264,"Greater outness predicted a lower KT ratio over time in non-Hispanic White SM men, but not among SM men of color (MOC).","[{'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Vincent', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Carrico', 'Affiliation': 'Department of Public Health Sciences.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Dilworth', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Fuchs', 'Affiliation': 'Division of Biological Chemistry.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Judith T', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Department of Medicine Social Sciences.'}, {'ForeName': 'Annesa', 'Initials': 'A', 'LastName': 'Flentje', 'Affiliation': 'Department of Community Health Systems.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000586']
702,33842907,"Effect of selenium supplementation on musculoskeletal health in older women: a randomised, double-blind, placebo-controlled trial.","Background


Observational and preclinical studies show associations between selenium status, bone health, and physical function. Most adults in Europe have serum selenium below the optimum range. We hypothesised that selenium supplementation could reduce pro-resorptive actions of reactive oxygen species on osteoclasts and improve physical function.
Methods


We completed a 6-month randomised, double-blind, placebo-controlled trial. We recruited postmenopausal women older than 55 years with osteopenia or osteoporosis at the Northern General Hospital, Sheffield, UK. Participants were randomly assigned 1:1:1 to receive selenite 200 μg, 50 μg, or placebo orally once per day. Medication was supplied to the site blinded and numbered by a block randomisation sequence with a block size of 18, and participants were allocated medication in numerical order. All participants and study team were masked to treatment allocation. The primary endpoint was urine N-terminal cross-linking telopeptide of type I collagen (NTx, expressed as ratio to creatinine) at 26 weeks. Analysis included all randomly assigned participants who completed follow-up. Groups were compared with analysis of covariance with Hochberg testing. Secondary endpoints were other biochemical markers of bone turnover, bone mineral density, short physical performance battery, and grip strength. Mechanistic endpoints were glutathione peroxidase, highly sensitive C-reactive protein, and interleukin-6. This trial is registered with EU clinical trials, EudraCT 2016-002964-15, and ClinicalTrials.gov, NCT02832648, and is complete.
Findings


120 participants were recruited between Jan 23, 2017, and April 11, 2018, and randomly assigned to selenite 200 μg, 50 μg, or placebo (n=40 per group). 115 (96%) of 120 participants completed follow-up and were included in the primary analysis (200 μg [n=39], 50 μg [n=39], placebo [n=37]). Median follow-up was 25·0 weeks (IQR 24·7-26·0). In the 200 μg group, mean serum selenium increased from 78·8 (95% CI 73·5-84·2) to 105·7 μg/L (99·5-111·9). Urine NTx to creatinine ratio (nmol bone collagen equivalent:mmol creatinine) did not differ significantly between treatment groups at 26 weeks: 40·5 (95% CI 34·9-47·0) for placebo, 43·4 (37·4-50·5) for 50 μg, and 42·2 (37·5-47·6) for 200 μg. None of the secondary or mechanistic endpoint measurements differed between treatment groups at 26 weeks. Seven (6%) of 120 participants were withdrawn from treatment at week 13 due to abnormal thyroid-stimulating hormone concentrations (one in the 200 μg group, three in the 50 μg group, and three in the placebo group) and abnormal blood glucose (one in the 50 μg group). There were three serious adverse events: a non-ST elevation myocardial infarction at week 18 (in the 50 μg group), a diagnosis of bowel cancer after routine population screening at week 2 (in the placebo group), and a pulmonary embolus due to metastatic bowel cancer at week 4 (in the 200 μg group). All severe adverse events were judged by the principal investigator as unrelated to trial medication.
Interpretation


Selenium supplementation at these doses does not affect musculoskeletal health in postmenopausal women.
Funding


UK National Institute for Health Research Efficacy and Mechanism Evaluation programme.",2021,"Urine NTx to creatinine ratio (nmol bone collagen equivalent:mmol creatinine) did not differ significantly between treatment groups at 26 weeks: 40·5 (95% CI 34·9-47·0) for placebo, 43·4 (37·4-50·5) for 50 μg, and 42·2 (37·5-47·6) for 200 μg.","['115 (96%) of 120 participants completed follow-up and were included in the primary analysis (200 μg [n=39], 50 μg [n=39], placebo [n=37', 'older women', 'postmenopausal women older than 55 years with osteopenia or osteoporosis at the Northern General Hospital, Sheffield, UK', 'Findings\n\n\n120 participants were recruited between Jan 23, 2017, and April 11, 2018', 'postmenopausal women']","['selenite 200 μg, 50 μg, or placebo', 'placebo', 'selenium supplementation', 'Selenium supplementation']","['urine N-terminal cross-linking telopeptide of type', 'glutathione peroxidase, highly sensitive C-reactive protein, and interleukin-6', 'mean serum selenium', 'pulmonary embolus due to metastatic bowel cancer', 'Urine NTx to creatinine ratio (nmol bone collagen equivalent:mmol creatinine', 'abnormal blood glucose', 'serious adverse events: a non-ST elevation myocardial infarction', 'All severe adverse events', 'biochemical markers of bone turnover, bone mineral density, short physical performance battery, and grip strength', 'diagnosis of bowel cancer', 'musculoskeletal health']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0036580', 'cui_str': 'Selenite'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0439822', 'cui_str': 'Highly sensitive'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0858170', 'cui_str': 'Serum selenium'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0346627', 'cui_str': 'Malignant tumor of intestine'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439191', 'cui_str': 'nmol'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1276061', 'cui_str': 'Acute non-ST segment elevation myocardial infarction'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",120.0,0.763507,"Urine NTx to creatinine ratio (nmol bone collagen equivalent:mmol creatinine) did not differ significantly between treatment groups at 26 weeks: 40·5 (95% CI 34·9-47·0) for placebo, 43·4 (37·4-50·5) for 50 μg, and 42·2 (37·5-47·6) for 200 μg.","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Walsh', 'Affiliation': 'Mellanby Centre for Musculoskeletal Research, University of Sheffield, Northern General Hospital, Sheffield, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Jacques', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Schomburg', 'Affiliation': 'Institut für Experimentelle Endokrinologie, Campus Virchow-Klinikum, Berlin, Germany.'}, {'ForeName': 'Tom R', 'Initials': 'TR', 'LastName': 'Hill', 'Affiliation': 'Human Nutrition Research Centre, Centre for Healthier Lives, Population Health Science Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Centre for Healthier Lives, Population Health Science Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Graham R', 'Initials': 'GR', 'LastName': 'Williams', 'Affiliation': 'Molecular Endocrinology Laboratory, Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Eastell', 'Affiliation': 'Mellanby Centre for Musculoskeletal Research, University of Sheffield, Northern General Hospital, Sheffield, UK.'}]",The Lancet. Healthy longevity,['10.1016/S2666-7568(21)00051-9']
703,33837400,Effectiveness of tailored intervention with a salutogenic approach to improve adherence in adults with hypertension: a non-randomized trial.,"AIMS


Hypertension (HTN) is a chronic long-term, slowly progressing disease. For HTN control, management, and prevention of associated complications, adequate adherence to treatment is required. It has been proposed that tailored interventions to individual needs are required to address the phenomenon of adherence to treatment. However, studies evaluating the effects of tailored interventions to improve adherence are still scarce. The aim of this study is to evaluate the effectiveness of a tailored intervention using a salutogenic approach, to improve adherence in patients with HTN.
METHODS AND RESULTS


A non-randomized trial design was used in this study. Adult patients with HTN were allocated in two groups: tailored intervention (n = 75) and standard care (n = 78). The content of the tailored intervention was based on personal resources and elaboration of an action plan with objectives in agreement with the patients. Patient outcomes (treatment adherence, blood pressure) were assessed both at the beginning of the study and at the 4-week follow-up for the intervention group and the standard care group. The Treatment Adherence Questionnaire for Patients with Hypertension was used to measure adherence. The results of this study showed that the total score and each dimension of the adherence questionnaire (medications, diet, physical activity, weight control, stimulation, and stress relief) increased significantly in the experimental group compared with the control group (P < 0.05). For the group assigned to tailored intervention, the delta score of the total adherence score increased in the final evaluation to 9.4 (95% CI = 8.60-10.28).
CONCLUSION


A tailored intervention with a salutogenic approach appears to be effective for improving adherence in patients with HTN. Randomized controlled trials are required to confirm the effect of tailored interventions in this type of population.",2022,"For the group assigned to tailored intervention, the delta score of the total adherence score increased in the final evaluation to 9.4 (95% CI = 8.60-10.28).
","['Adult patients with HTN', 'Patients with Hypertension', 'adults with hypertension', 'patients with HTN']","['tailored intervention with a salutogenic approach', 'tailored intervention (n\u2009=\u200975) and standard care']","['delta score of the total adherence score', 'total score and each dimension of the adherence questionnaire (medications, diet, physical activity, weight control, stimulation, and stress relief', 'Patient outcomes (treatment adherence, blood pressure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.0102472,"For the group assigned to tailored intervention, the delta score of the total adherence score increased in the final evaluation to 9.4 (95% CI = 8.60-10.28).
","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Esquivel Garzón', 'Affiliation': 'Department of Clinical Sciences, Cl. 42 # 1B-1, Universidad del Tolima, Ibagué, 730001, Colombia.'}, {'ForeName': 'Luz Patricia', 'Initials': 'LP', 'LastName': 'Díaz Heredia', 'Affiliation': 'Faculty of Nursing, Universidad Nacional de Colombia, Cra.30 #45-03 Ciudad Universitaria. Edificio 228, Piso 3, Of. 306, Bogotá, 111321, Colombia.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Grisales Romero', 'Affiliation': 'Demography and Health Research Group, National School of Public Health, Universidad de Antioquia, Cl. 62 #52-59, Medellín, 050010, Colombia.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Cañon-Montañez', 'Affiliation': 'Faculty of Nursing, Universidad de Antioquia, Cl. 64 #53-09, Medellín, 050010, Colombia.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1093/eurjcn/zvab030']
704,33838950,"[For obese patients or for patients who are overweight and have an associated comorbidity, how safe and effective is semaglutide as compared with placebo as an adjunct to lifestyle intervention for reducing body weight and other related end points?]",,2021,,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0460906,,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lanthier', 'Affiliation': 'Service de médecine interne générale, département de médecine spécialisé, Université de Sherbrooke, Sherbrooke, QC, Canada. Electronic address: luc.lanthier@usherbrooke.ca.'}, {'ForeName': 'M-F', 'Initials': 'MF', 'LastName': 'Langlois', 'Affiliation': ""Service d'endocrinologie, département de médecine spécialisé, Université de Sherbrooke, Sherbrooke, QC, Canada.""}, {'ForeName': 'M-É', 'Initials': 'MÉ', 'LastName': 'Plourde', 'Affiliation': 'Service de radio-oncologie, département de médecine nucléaire et radiobiologie, Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cauchon', 'Affiliation': ""Département de médecine familiale et de médecine d'urgence, Université Laval, Québec, QC, Canada.""}]",La Revue de medecine interne,['10.1016/j.revmed.2021.03.334']
705,33847758,Randomized Controlled Trial of Cognitive-Behavioral and Mindfulness-Based Stress Reduction on the Quality of Life of Patients With Crohn Disease.,"BACKGROUND


Patients with Crohn disease have debilitating psychological symptoms, mental fatigue, and poor quality of life. Psychological intervention may improve these symptoms.
METHODS


We performed a randomized parallel-group physician-blinded trial of cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX) on quality of life and psychological symptoms in adults with mild-moderate Crohn disease. COBMINDEX was taught by social workers in one-on-one video conferences over 3 months; quotidian home practice was mandated.
RESULTS


Fifty-five COBMINDEX and 61 waitlist control patients completed the study; mean age was 33 years and 65% of participants were women. At 3 months, COBMINDEX patients had significantly reduced disease activity (per Harvey-Bradshaw Index score, C-reactive protein level, and calprotectin level), increased quality of life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ] score increased from baseline 41 to 50; P < 0.001), decreased psychological symptoms (Global Severity Index [GSI], 0.98-0.70; P < 0.001), reduced fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue, 26-33; P < 0.001), and increased mindfulness disposition (Freiburg Mindfulness Inventory, 33-38; P < 0.001). Waitlist patients had a significant but small change in Harvey-Bradshaw Index, SIBDQ, and GSI scores, without improvement in fatigue or mindfulness. There were significant correlations (0.02 > P < 0.002) in COBMINDEX patients between baseline SIBDQ, GSI, Freiburg Mindfulness Inventory, and Functional Assessment of Chronic Illness Therapy-Fatigue scores with a relative change (baseline to 3 months) of the SIBDQ score, but none among waitlist patients. Predictors of relative change of the SIBDQ score in COBMINDEX patients included the GSI score (90% quantile; coefficient 0.52; P < 0.001), somatization (90%; 0.20; P = 0.001), depression (75%; 0.16; P = 0.03), and phobic anxiety (75%; 0.31; P = 0.008).
CONCLUSIONS


COBMINDEX was effective in increasing patients' quality of life and reducing psychological symptoms and fatigue. Patients with severe baseline psychological symptoms benefited the most from COBMINDEX.",2022,"Waitlist patients had a significant but small change in Harvey-Bradshaw Index, SIBDQ, and GSI scores, without improvement in fatigue or mindfulness.","['Fifty-five', 'Patients with Crohn disease', 'adults with mild-moderate Crohn disease', 'Patients With Crohn Disease', 'Patients with severe baseline psychological symptoms', '61 waitlist control patients completed the study; mean age was 33 years and 65% of participants were women']","['Psychological intervention', 'Cognitive-Behavioral and Mindfulness-Based Stress Reduction', 'cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX']","['depression', 'GSI, Freiburg Mindfulness Inventory, and Functional Assessment of Chronic Illness Therapy-Fatigue scores', 'quality of life and psychological symptoms', 'disease activity (per Harvey-Bradshaw Index score, C-reactive protein level, and calprotectin level), increased quality of life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ] score', 'SIBDQ score', 'Quality of Life', 'somatization', ""patients' quality of life and reducing psychological symptoms and fatigue"", 'psychological symptoms (Global Severity Index [GSI', 'reduced fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue', 'small change in Harvey-Bradshaw Index, SIBDQ, and GSI scores', 'phobic anxiety', 'fatigue or mindfulness', 'mindfulness disposition']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}]",,0.201347,"Waitlist patients had a significant but small change in Harvey-Bradshaw Index, SIBDQ, and GSI scores, without improvement in fatigue or mindfulness.","[{'ForeName': 'Ganit', 'Initials': 'G', 'LastName': 'Goren', 'Affiliation': 'Spitzer Department of Social Work, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Schwartz', 'Affiliation': 'Department of Gastroenterology and Hepatology, Soroka Medical Center, Beer Sheva, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friger', 'Affiliation': 'Department of Public Health, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Hagar', 'Initials': 'H', 'LastName': 'Banai', 'Affiliation': 'Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Sergienko', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Regev', 'Affiliation': 'Spitzer Department of Social Work, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Abu-Kaf', 'Affiliation': 'Department of Gastroenterology and Hepatology, Soroka Medical Center, Beer Sheva, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Greenberg', 'Affiliation': 'Department of Health Systems Management, School of Public Health, Guilford Glazer Faculty of Business and Management, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nemirovsky', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Karny', 'Initials': 'K', 'LastName': 'Ilan', 'Affiliation': 'The Shraga Segal Department of Microbiology and Immunology, Faculty of Health Sciences, The National Institute for Biotechnology in the Negev, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Livnat', 'Initials': 'L', 'LastName': 'Lerner', 'Affiliation': 'The Shraga Segal Department of Microbiology and Immunology, Faculty of Health Sciences, The National Institute for Biotechnology in the Negev, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Monsonego', 'Affiliation': 'The Shraga Segal Department of Microbiology and Immunology, Faculty of Health Sciences, The National Institute for Biotechnology in the Negev, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Dotan', 'Affiliation': 'Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Henit', 'Initials': 'H', 'LastName': 'Yanai', 'Affiliation': 'Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Eliakim', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Shomron', 'Initials': 'S', 'LastName': 'Ben Horin', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Vered', 'Initials': 'V', 'LastName': 'Slonim-Nevo', 'Affiliation': 'Spitzer Department of Social Work, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Odes', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Orly', 'Initials': 'O', 'LastName': 'Sarid', 'Affiliation': 'Spitzer Department of Social Work, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}]",Inflammatory bowel diseases,['10.1093/ibd/izab083']
706,33833379,One-year outcomes after treatment with a drug-coated balloon catheter system for lower urinary tract symptoms related to benign prostatic hyperplasia.,"BACKGROUND


This is the first report of the 1-year outcomes of the EVEREST-I study evaluating the safety and efficacy of the Optilume ®  BPH Catheter System, a prostatic paclitaxel-coated balloon catheter system, for the treatment of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH).
METHODS


Subjects were men >50 years old with moderate-to-severe LUTS secondary to BPH, peak urinary flow rate of 5-15 ml/s, prostatic urethra length 30-55 mm, and prostate volume 20-80 g. All were treated with the Optilume BPH Catheter System and followed at Foley removal, 2 weeks, 30 days, 3, 6, and 12 months after treatment. The primary endpoint was the proportion of subjects with ≥40% improvement in International Prostate Symptom Score (IPSS). The rate of post-procedural complications was evaluated.
RESULTS


Eighty subjects were treated at six sites in Latin America and 75 completed the 1-year follow-up. The percent of subjects with an improvement ≥40% in IPSS from baseline was 81% at 3 months and 1 year. IPSS improved from 22.3 at baseline to 7.9 at 1 year, Qmax improved from 10.9 to 18.4 ml/s, and IPSS QoL improved from 4.6 to 1.3. Post-procedural complications included common urologic events and the rate of complications was significantly impacted by device diameter.
CONCLUSIONS


Treatment with the minimally invasive Optilume BPH Catheter System is safe and showed subjective and objective improvements in LUTS. Benefits were rapid and persisted through 1 year. The initial results warrant further evaluation of this therapy as a treatment option for patients with LUTS related to BPH.",2021,"CONCLUSIONS


Treatment with the minimally invasive Optilume BPH Catheter System is safe and showed subjective and objective improvements in LUTS.","['lower urinary tract symptoms', 'Subjects were men >50 years old with moderate-to-severe LUTS secondary to BPH, peak urinary flow rate of 5-15\u2009ml/s, prostatic urethra length 30-55\u2009mm, and prostate volume 20-80\u2009g. All were treated with the', 'Eighty subjects were treated at six sites in Latin America and 75 completed the 1-year follow-up', 'patients with LUTS related to BPH']","['EVEREST', 'drug-coated balloon catheter system', 'Optilume ®  BPH Catheter System, a prostatic paclitaxel-coated balloon catheter system', 'Optilume BPH Catheter System']","['Qmax', 'rate of post-procedural complications', 'safety and efficacy', 'proportion of subjects with ≥40% improvement in International Prostate Symptom Score (IPSS', 'rate of complications', 'IPSS QoL', 'IPSS']","[{'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}, {'cui': 'C0439390', 'cui_str': 'mL/s'}, {'cui': 'C0458450', 'cui_str': 'Prostatic urethra structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C1141930', 'cui_str': 'Post procedural complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",80.0,0.0624465,"CONCLUSIONS


Treatment with the minimally invasive Optilume BPH Catheter System is safe and showed subjective and objective improvements in LUTS.","[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': 'Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY, USA. steven.kaplan@mountsinai.org.'}, {'ForeName': 'Merycarla', 'Initials': 'M', 'LastName': 'Pichardo', 'Affiliation': 'URUS, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Rijo', 'Affiliation': 'Centro Médico Dr. Canela SRL, La Romana, Dominican Republic.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Espino', 'Affiliation': 'Centro Especializado San Fernando, Panama City, Panama.'}, {'ForeName': 'Ramon Rodriguez', 'Initials': 'RR', 'LastName': 'Lay', 'Affiliation': 'Edificio Royal Center, Panama City, Panama.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Estrella', 'Affiliation': 'Clínica Unión Medica, Santiago de los Caballeros, Dominican Republic.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-021-00362-z']
707,33833378,What is the effect of MRI with targeted biopsies on the rate of patients discontinuing active surveillance? A reflection of the use of MRI in the PRIAS study.,"BACKGROUND


The reduction of overtreatment by active surveillance (AS) is limited in patients with low-risk prostate cancer (PCa) due to high rates of patients switching to radical treatment. MRI improves biopsy accuracy and could therewith affect inclusion in or continuation of AS. We aim to assess the effect of MRI with target biopsies on the total rate of patients discontinuing AS, and in particular discontinuation due to Grade Group (GG) reclassification.
METHODS


Three subpopulations included in the prospective PRIAS study with GG 1 were studied. Group A consists of patients diagnosed before 2009 without MRI before or during AS. Group B consists of patients diagnosed without MRI, but all patients underwent MRI within 6 months after diagnosis. Group C consists of patients who underwent MRI before diagnosis and during follow-up. We used cumulative incidence curves to estimate the rates of discontinuation.
RESULTS


In Group A (n = 500), the cumulative probability of discontinuing AS at 2 years is 27.5%; GG reclassification solely accounted for 6.9% of the discontinuation. In Group B (n = 351) these numbers are 30.9 and 22.8%, and for Group C (n = 435) 24.2 and 13.4%. The three groups were not randomized, however, baseline characteristics are highly comparable.
CONCLUSIONS


Performing an MRI before starting AS reduces the cumulative probability of discontinuing AS at 2 years. Performing an MRI after already being on AS increases the cumulative probability of discontinuing AS in comparison to not performing an MRI, especially because of an increase in GG reclassification. These results suggest that the use of MRI could lead to more patients being considered unsuitable for AS. Considering the excellent long-term cancer-specific survival of AS before the MRI era, the increased diagnostic accuracy of MRI could potentially lead to more overtreatment if definitions and treatment options of significant PCa are not adapted.",2021,"Performing an MRI after already being on AS increases the cumulative probability of discontinuing AS in comparison to not performing an MRI, especially because of an increase in GG reclassification.","['Three subpopulations included in the prospective PRIAS study with GG 1 were studied', 'patients with low-risk prostate cancer (PCa', 'patients discontinuing AS, and in particular discontinuation due to Grade Group (GG) reclassification']",['MRI'],"['biopsy accuracy', 'cumulative probability', 'cumulative probability of discontinuing AS']","[{'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]",,0.0417329,"Performing an MRI after already being on AS increases the cumulative probability of discontinuing AS in comparison to not performing an MRI, especially because of an increase in GG reclassification.","[{'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'Luiting', 'Affiliation': 'Department of Urology, Erasmus University Medical Centre Cancer Institute, Rotterdam, The Netherlands. h.luiting@erasmusmc.nl.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Remmers', 'Affiliation': 'Department of Urology, Erasmus University Medical Centre Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Valdagni', 'Affiliation': 'Department of Oncology and Haemato-oncology, Università degli Studi di Milano. Radiation Oncology 1, Prostate Cancer Program, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Boevé', 'Affiliation': 'Department of Urology, Sint Franciscus Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Staerman', 'Affiliation': 'Department of Urology, Polycliniques REIMS-BEZANNES, Reims, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rueb', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Herne, Germany.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Somford', 'Affiliation': 'Department of Urology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pickles', 'Affiliation': 'Department of Radiation Oncology, Vancouver Center, BC Cancer, Vancouver, BC, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rannikko', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Roobol', 'Affiliation': 'Department of Urology, Erasmus University Medical Centre Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Prostate cancer and prostatic diseases,['10.1038/s41391-021-00343-2']
708,33844435,Promoting mother-infant relationships and underlying neural correlates: Results from a randomized controlled trial of a home-visiting program for adolescent mothers in Brazil.,"Poverty and teenage pregnancy are common in low-and-middle-income countries and can impede the development of healthy parent-child relationships. This study aimed to test whether a home-visiting intervention could improve early attachment relationships between adolescent mothers and their infants living in poverty in Brazil. Analyses were conducted on secondary outcomes from a randomized controlled trial (NCT0280718) testing the efficacy of a home-visiting program, Primeiros Laços, on adolescent mothers' health and parenting skills and their infants' development. Pregnant youth were randomized to intervention (n = 40) or care-as-usual (CAU, n = 40) from the first trimester of pregnancy until infants were aged 24 months. Mother-infant attachment was coded during a mother-infant interaction when the infants were aged 12 months. Electrophysiological correlates of social processing (mean amplitude of the Nc component) were measured while infants viewed facial images of the mother and a stranger at age 6 months. Infants in the intervention group were more securely attached and more involved with their mothers than those receiving CAU at 12 months. Smaller Nc amplitudes to the mother's face at 6 months were associated with better social behavior at 12 months. Our findings indicate that the Primeiros Laços Program is effective in enhancing the development of mother-infant attachment.",2021,Infants in the intervention group were more securely attached and more involved with their mothers than those receiving CAU at 12 months.,"['adolescent mothers in Brazil', 'adolescent mothers and their infants living in poverty in Brazil', ""adolescent mothers' health and parenting skills and their infants' development"", 'Pregnant youth']","['home-visiting program', 'home-visiting program, Primeiros Laços', 'home-visiting intervention', 'care-as-usual (CAU']","['early attachment relationships', 'social behavior', 'Electrophysiological correlates of social processing (mean amplitude of the Nc component']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444892', 'cui_str': 'CAU'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",40.0,0.0412429,Infants in the intervention group were more securely attached and more involved with their mothers than those receiving CAU at 12 months.,"[{'ForeName': 'Fernanda Speggiorin Pereira', 'Initials': 'FSP', 'LastName': 'Alarcão', 'Affiliation': 'Department of Psychiatry, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Shephard', 'Affiliation': 'Department of Psychiatry, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fatori', 'Affiliation': 'Department of Psychiatry, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Amável', 'Affiliation': 'Department of Psychiatry, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Chiesa', 'Affiliation': 'School of Nursing, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lislaine', 'Initials': 'L', 'LastName': 'Fracolli', 'Affiliation': 'School of Nursing, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Matijasevich', 'Affiliation': 'Department of Preventive Medicine, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Brentani', 'Affiliation': 'Department of Psychiatry, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Laboratories of Cognitive Neuroscience, Division of Developmental Medicine, Boston Children's Hospital, Harvard Medical School, Boston, USA.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Leckman', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, USA.'}, {'ForeName': 'Eurípedes Constantino', 'Initials': 'EC', 'LastName': 'Miguel', 'Affiliation': 'Department of Psychiatry, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Guilherme V', 'Initials': 'GV', 'LastName': 'Polanczyk', 'Affiliation': 'Department of Psychiatry, Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}]",Developmental science,['10.1111/desc.13113']
709,33844408,Epigastric symptom response to low FODMAP dietary advice compared with standard dietetic advice in individuals with functional dyspepsia.,"BACKGROUND


Certain dietary constituents may provoke symptoms of functional dyspepsia (FD); however, there is an absence of dietary trials testing specific dietary interventions. Empirically derived dietary strategies and the low FODMAP diet are frequently used in practice. This study aimed to compare the effectiveness of low FODMAP dietary advice with standard dietary advice for reducing epigastric and overall gastrointestinal symptoms in individuals with FD.
METHODS


Data were collected from 59 consecutive eligible individuals with FD attending an initial and review outpatient dietetic consultation at Princess Alexandra Hospital. Of these, 40 received low FODMAP advice and 19 received standard dietary advice. As part of usual care, the Structured Assessment of Gastrointestinal Symptom Scale (SAGIS) was used to assess epigastric (maximum score = 28) and overall gastrointestinal symptoms (maximum score = 88). Dietary adherence data were collected, and change in symptom score and proportion of responders (defined as a ≥30% reduction in score) for epigastric and total symptoms was calculated.
KEY RESULTS


Most individuals (48/59, 81%) had FD and coexisting irritable bowel syndrome. There was a greater reduction in epigastric score in those receiving low FODMAP dietary advice compared with those receiving standard advice (est. marginal mean [95% CI]: -3.6 [-4.9, -2.2] vs. -0.9 [-2.9, 1.1], p = 0.032) and total symptom score (-9.4 [-12.4, -6.4] vs. -3.3 [-7.7, 1.1] p = 0.026). A greater proportion receiving low FODMAP dietary advice were responders versus those receiving standard advice (50% vs. 16%, p = 0.012). Dietary adherence did not differ between groups (p = 0.497).
CONCLUSIONS & INFERENCES


The low FODMAP diet appears more effective for improving epigastric symptoms in people with FD compared with standard advice. A randomized controlled trial is required to substantiate these findings.",2021,The low FODMAP diet appears more effective for improving epigastric symptoms in people with FD compared with standard advice.,"['individuals with functional dyspepsia', 'individuals with FD', '59 consecutive eligible individuals with FD attending an initial and review outpatient dietetic consultation at Princess Alexandra Hospital']","['low FODMAP dietary advice with standard dietary advice', 'low FODMAP dietary advice', 'standard dietetic advice', 'low FODMAP advice and 19 received standard dietary advice']","['Epigastric symptom response', 'Dietary adherence', 'epigastric and total symptoms', 'epigastric and overall gastrointestinal symptoms', 'FD and coexisting irritable bowel syndrome', 'epigastric score', 'total symptom score', 'Gastrointestinal Symptom Scale (SAGIS', 'overall gastrointestinal symptoms', 'Dietary adherence data', 'epigastric symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0401706,The low FODMAP diet appears more effective for improving epigastric symptoms in people with FD compared with standard advice.,"[{'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Staudacher', 'Affiliation': 'Department of Nutrition and Dietetics, Princess Alexandra Hospital, Brisbane, Qld, Australia.'}, {'ForeName': 'Amy N', 'Initials': 'AN', 'LastName': 'Nevin', 'Affiliation': 'Department of Nutrition and Dietetics, Princess Alexandra Hospital, Brisbane, Qld, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Duff', 'Affiliation': 'Department of Nutrition and Dietetics, Princess Alexandra Hospital, Brisbane, Qld, Australia.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Kendall', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Qld, Australia.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Holtmann', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Qld, Australia.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.14148']
710,33847977,Embryo Morphokinetics and Blastocyst Development After GnRH Agonist versus hCG Triggering in Normo-ovulatory Women: a Secondary Analysis of a Multicenter Randomized Controlled Trial.,"Gonadotropin-releasing hormone agonist (GnRHa) for final oocyte maturation, along with vitrification of all usable embryos followed by transfer in a subsequent frozen-thawed cycle, is the most effective strategy to avoid ovarian hyperstimulation syndrome (OHSS). However, less is known about the ovulation induction triggers effect on early embryo development and blastocyst formation. This study is a secondary analysis of a multicenter, randomized controlled trial, with the aim to compare embryo development in normo-ovulatory women, randomized to GnRHa or human chorionic gonadotropin (hCG) trigger. In all, 4056 retrieved oocytes were observed, 1998 from the GnRHa group (216 women) and 2058 from the hCG group (218 women). A number of retrieved oocytes, mature and fertilized oocytes, and high-quality embryos and blastocysts were similar between the groups. A sub-analysis in 250 women enrolled at the main trial site including 2073 oocytes was conducted to compare embryo morphokinetics and cleavage patterns with EmbryoScope time-lapse system. In total, 1013 oocytes were retrieved from the GnRHa group (124 women) and 1060 oocytes were retrieved from the hCG group (126 women). Morphokinetic parameters and cleavage patterns were comparable between the groups. However, embryos derived from the GnRHa group were less likely to perform rolling during their development than the embryos from the hCG trigger group (OR = 0.41 (95%CI 0.25; 0.67), p-value 0.0003). The comparable results on embryo development and utilization rates between the GnRHa and hCG triggers is of clinical relevance to professionals and infertile patients, when GnRHa trigger and freeze-all is performed to avoid OHSS development. ClinicalTrials.gov Identifier: NCT02746562.",2021,"The comparable results on embryo development and utilization rates between the GnRHa and hCG triggers is of clinical relevance to professionals and infertile patients, when GnRHa trigger and freeze-all is performed to avoid OHSS development.","['normo-ovulatory women', 'Normo-ovulatory Women', '4056 retrieved oocytes were observed, 1998 from the GnRHa group (216 women) and 2058 from the hCG group (218 women', 'In total, 1013 oocytes were retrieved from the GnRHa group (124 women) and 1060 oocytes were retrieved from the hCG group (126 women', '250 women enrolled at the main trial site including 2073 oocytes was conducted to compare embryo morphokinetics and cleavage patterns with EmbryoScope time-lapse system']","['GnRH Agonist versus hCG', 'Gonadotropin-releasing hormone agonist (GnRHa', 'GnRHa or human chorionic gonadotropin (hCG']","['retrieved oocytes, mature and fertilized oocytes, and high-quality embryos and blastocysts', 'embryo development and utilization rates', 'Morphokinetic parameters and cleavage patterns', 'Embryo Morphokinetics and Blastocyst Development']","[{'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0752061', 'cui_str': 'Embryoscopes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}]","[{'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029974', 'cui_str': 'Ovum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0013936', 'cui_str': 'Embryo Development'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",250.0,0.158826,"The comparable results on embryo development and utilization rates between the GnRHa and hCG triggers is of clinical relevance to professionals and infertile patients, when GnRHa trigger and freeze-all is performed to avoid OHSS development.","[{'ForeName': 'Evaggelia', 'Initials': 'E', 'LastName': 'Alexopoulou', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark. Evangelia.alexopoulou.02@regionh.dk.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Stormlund', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Løssl', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, DK-2100, Copenhagen Ø, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Prætorius', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark.'}, {'ForeName': 'Negjyp', 'Initials': 'N', 'LastName': 'Sopa', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark.'}, {'ForeName': 'Jeanette Wulff', 'Initials': 'JW', 'LastName': 'Bogstad', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark.'}, {'ForeName': 'Anne Lis', 'Initials': 'AL', 'LastName': 'Mikkelsen', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Sealland University Hospital Køge, Lykkebækvej 1, DK-4600, Køge, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Forman', 'Affiliation': 'Section of Biostatistics, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5B, DK-1014, Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'la Cour Freiesleben', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark.'}, {'ForeName': 'Janni', 'Initials': 'J', 'LastName': 'Vikkelsø Jeppesen', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, DK-2100, Copenhagen Ø, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bergh', 'Affiliation': 'Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Reproductive Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Peter Samir Heskjær', 'Initials': 'PSH', 'LastName': 'Al Humaidan', 'Affiliation': 'The Fertility Clinic, Skive Regional Hospital, Faculty of Health Aarhus University, Resenvej 25, Skive, 7800, Denmark.'}, {'ForeName': 'Marie Louise', 'Initials': 'ML', 'LastName': 'Grøndahl', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Herlev, Borgmester Ib Juuls vej 9, DK-2750, Herlev, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zedeler', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark.'}, {'ForeName': 'Anja Bisgaard', 'Initials': 'AB', 'LastName': 'Pinborg', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Kettegård Alle 30, DK-2650, Hvidovre, Denmark.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-021-00564-9']
711,33847862,Gender differences with short-term vs 12 months dual antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO dual therapy stent: 2-years follow-up results of the REDUCE trial.,"BACKGROUND


Gender differences in the thrombotic and bleeding risk have been suggested to condition the benefits of antithrombotic therapies in Acute Coronary Syndrome (ACS) patients, and mainly among those undergoing percutaneous coronary interventions with drug eluting stents (DES). The impact of gender on the optimal duration of dual antiplatelet therapy (DAPT) in ACS patients is still unexplored and was, therefore, the aim of the present sub-study.
METHODS


REDUCE was a prospective, multicenter, randomized investigator-initiated study designed to enroll 1500 ACS patients after treatment with the COMBO Dual Stent Therapy, based on a noninferiority design. Patients were randomized in a 1:1 fashion to either 3 or 12 months of DAPT. Primary study endpoint was a composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleedings (BARC II, III, V) at 12 months. Secondary endpoints were cardiovascular mortality and the individual components of the primary endpoint within 24 months.
RESULTS


From June 2014 to May 2016 300 women and 1196 men were included in the study. Among them, 43.7% of females and 51.9% of males were assigned to the 3 months DAPT treatment. Baseline characteristics were well matched between the two arms, with the exception of a lower rate of TIMI flow < 3 (p = 0.04), lower systolic blood pressure (p = 0.05) and use of spironolactone (p = 0.006) among women and a more advanced age (p = 0.05) among men receiving a short-term DAPT. At a mean follow-up of 525 (± 198) days, no difference in the primary endpoint was observed according to DAPT duration in both females [6.9% vs 5.9%, HR (95% CI) = 1.19 (0.48-2.9), p = 0.71] and males [8.2% vs 9%, HR (95% CI) = 0.92 (0.63-1.35), p = 0.67; p INT = 0.20]. Results were confirmed after correction for baseline differences [females: adjusted HR (95% CI) = 1.12 (0.45-2.78), p = 0.81; males: adjusted HR (95% CI) = 0.90 (0.61-1.32), p = 0.60]. Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of gender.
CONCLUSIONS


The present study shows that among ACS patients randomized in the REDUCE trial, a 3 months DAPT strategy offers comparable results as compared to a standard 12 months DAPT at 2-years follow-up in both male and female gender.",2021,"Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of gender.
","['From June 2014 to May 2016 300 women and 1196 men were included in the study', '1500 ACS patients after treatment with the COMBO Dual Stent Therapy, based on a noninferiority design', 'Acute Coronary Syndrome (ACS) patients, and mainly among those undergoing percutaneous coronary interventions with drug eluting stents (DES', 'ACS patients', 'patients with acute coronary syndrome treated with the COMBO dual therapy stent']","['DAPT', 'spironolactone', 'dual antiplatelet therapy (DAPT']","['cardiovascular mortality and the individual components of the primary endpoint within 24\xa0months', 'composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleedings (BARC II, III, V', 'lower systolic blood pressure', 'DAPT duration', 'survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events', 'rate of TIMI flow']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0277885', 'cui_str': 'Decreased systolic arterial pressure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",300.0,0.109172,"Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of gender.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Verdoia', 'Affiliation': 'AOU Maggiore Della Carità, Eastern Piedmont University, Novara, Italy.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Suryapranata', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Damen', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Camaro', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Benit', 'Affiliation': 'Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Barbieri', 'Affiliation': 'AOU Maggiore Della Carità, Eastern Piedmont University, Novara, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rasoul', 'Affiliation': 'Atrium Medical Center, Heerlen, The Netherlands.'}, {'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'Liew', 'Affiliation': 'Queen Elizabeth II, Sabah, Malaysia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Polad', 'Affiliation': ""Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, The Netherlands.""}, {'ForeName': 'W A W', 'Initials': 'WAW', 'LastName': 'Ahmad', 'Affiliation': 'University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zambahari', 'Affiliation': 'National Heart Institute, Kuala Lumpur, Malaysia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lalmand', 'Affiliation': 'Centre Hospitalier Universitaire, Charleroi, Belgium.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Koh', 'Affiliation': 'National Heart Center, Singapore, Singapore.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Timmermans', 'Affiliation': 'Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dilling-Boer', 'Affiliation': 'Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Veenstra', 'Affiliation': 'Atrium Medical Center, Heerlen, The Netherlands.'}, {'ForeName': 'A W J', 'Initials': 'AWJ', 'LastName': ""Van't Hof"", 'Affiliation': 'Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'S W L', 'Initials': 'SWL', 'LastName': 'Lee', 'Affiliation': 'Queen Mary Hospital, University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Roolvink', 'Affiliation': 'Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ligtenberg', 'Affiliation': 'OrbusNeich Medical BV, Hoevelaken, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Postma', 'Affiliation': 'Diagram BV, Zwolle, The Netherlands.'}, {'ForeName': 'E J J', 'Initials': 'EJJ', 'LastName': 'Kolkman', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Brouwer', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kedhi', 'Affiliation': 'Erasmus Hospital, Bruxelles, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'De Luca', 'Affiliation': 'AOU Maggiore Della Carità, Eastern Piedmont University, Novara, Italy. giuseppe.deluca@med.uniupo.it.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-021-02439-x']
712,33849715,"Optimization of pulmonary function, functional capacity, and quality of life in adolescents with thoracic burns after a 2-month arm cycling exercise programme: A randomized controlled study.","BACKGROUND


Burns to the thorax are at high risk for long-term pulmonary complications due to chest muscle contractures and chronic inflammation in both adolescents and young adults. Few studies have investigated the effects of arm cycling exercise in those individuals. For that reason, this study examined pulmonary function, functional capacity, and quality of life (QOL) in adolescents with thoracic burns subsequent to 2-month arm cycling exercise programme.
METHODS


A single-blinded, two-month randomized prospective controlled study was carried out between July 2019 and March 2020 on thirty adolescents with chest burns aged 11-17 years. They were randomized into two equal groups (n = 15), traditional physiotherapy programme (control group), and arm cycling exercise plus traditonal physiotherapy (arm cycling exercise group) for 2 consecutive months. Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), six-minute walk test (6MWT), and Pediatric Quality of Life Inventory (PedsQL) were measured in both groups at baseline and after 2-month after intervention.
RESULTS


No statistical significance was detected at baseline between control and arm cycling exercise groups (FVC, p = 0.903, FEV1, p = 0.835, 6MWT, p = 0.817, and PedsQL, p = 0.612). 2 months after intervention showed statistical improvements in the arm cycling exercise group in all measures (FVC, p = 0.001, FEV1, p < 0.0001, 6MWT, p = 0.001, and PedsQL, p = 0.001) however, the control group showed statistical improvements in FVC, p = 0.044 and FEV1, p = 0.024 with non-statistically significant changes in 6MWT, p = 0.145 and PedsQL, p = 0.067. The arm cycling exercise group showed greater improvements than control group in the outcome measures (FVC, p = 0.034, FEV1, p < 0.017, 6MWT, p = 0.037, and PedsQL, p = 0.021).
CONCLUSIONS


This prospective study clearly demonstrated positive and beneficial influences of two-month arm cycling exercise in the optimization of pulmonary functions, functional performance, and QOL in adolescents suffering from chest burns and thereby eliminating post-burn complications.",2022,"2 months after intervention showed statistical improvements in the arm cycling exercise group in all measures (FVC, p = 0.001, FEV1, p < 0.0001, 6MWT, p = 0.001, and PedsQL, p = 0.001) however, the control group showed statistical improvements in FVC, p = 0.044 and FEV1, p = 0.024 with non-statistically significant changes in 6MWT, p = 0.145 and PedsQL, p = 0.067.","['adolescents with thoracic burns subsequent to 2-month arm cycling exercise programme', 'July 2019 and March 2020 on thirty adolescents with chest burns aged 11-17 years', 'adolescents and young adults', 'adolescents suffering from chest burns and thereby eliminating post-burn complications', 'adolescents with thoracic burns after a 2-month arm cycling exercise programme']","['traditional physiotherapy programme (control group), and arm cycling exercise plus traditonal physiotherapy (arm cycling exercise group', 'cycling exercise']","['pulmonary functions, functional performance, and QOL', 'pulmonary function, functional capacity, and quality of life', 'pulmonary function, functional capacity, and quality of life (QOL', 'Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), six-minute walk test (6MWT), and Pediatric Quality of Life Inventory (PedsQL']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0740396', 'cui_str': 'Chest burning'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",30.0,0.0362257,"2 months after intervention showed statistical improvements in the arm cycling exercise group in all measures (FVC, p = 0.001, FEV1, p < 0.0001, 6MWT, p = 0.001, and PedsQL, p = 0.001) however, the control group showed statistical improvements in FVC, p = 0.044 and FEV1, p = 0.024 with non-statistically significant changes in 6MWT, p = 0.145 and PedsQL, p = 0.067.","[{'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia; Department of Physical Therapy, Kasr Al-Aini Hospital, Cairo University, Giza, Egypt. Electronic address: walidkamal.wr@gmail.com.'}, {'ForeName': 'Shereen H', 'Initials': 'SH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health and Rehabilitation Sciences, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Nambi', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Bader A', 'Initials': 'BA', 'LastName': 'Alqahtani', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Osailan', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Alshimaa R', 'Initials': 'AR', 'LastName': 'Azab', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia; Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Samah A', 'Initials': 'SA', 'LastName': 'Moawd', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia; Department of Physical Therapy for Cardiovascular/Respiratory Disorders and Geriatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Zeinab A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt; Department of Physical Therapy, College of Applied Medical Sciences in Al-Qurayyat, Jouf University, Saudi Arabia.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Ramadan S', 'Initials': 'RS', 'LastName': 'Hussein', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Marwa M', 'Initials': 'MM', 'LastName': 'Eid', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt; Department of Physical Therapy, College of Applied Medical Sciences, Taif University, Taif, Saudi Arabia.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2021.03.010']
713,33839766,The Effect of a Consumer-Based Activity Tracker Intervention on Accelerometer-Measured Sedentary Time Among Retirees: A Randomized Controlled REACT Trial.,"BACKGROUND


Effective strategies to reverse the increasing trend of sedentary behavior after retirement are needed. The aim of this study was to examine the effect of 12-month activity tracker-based intervention on daily total and prolonged sedentary time (≥60 minutes) among recent retirees.
METHODS


Randomization to intervention and control groups was performed to 231 retirees (mean age 65.2 [SD 1.1] years, 83% women). Intervention participants wore a consumer-based wrist-worn activity tracker (Polar Loop 2, Polar, Kempele, Finland), including daily activity goal, every day and night for 12 months. The activity tracker also gave vibrating reminders to break up uninterrupted inactivity periods after 55 minutes. A wrist-worn triaxial ActiGraph wGT3X-BT accelerometer was used to measure sedentary time at baseline and at 3-, 6-, and 12-month time points.
RESULTS


The use of an activity tracker did not reduce daily total or prolonged sedentary time over 12 months (p values for time * group interaction 0.39 and 0.27, respectively). In the post hoc analysis focusing on short- and medium-term effects on prolonged sedentary time, no differences between the intervention and control groups over 3 months were found, but a tendency for a greater decrease in prolonged sedentary time in the intervention group over 6 months was seen (mean difference in changes between the groups 29 minutes, 95% CI -2 to 61).
CONCLUSIONS


The activity tracker with inactivity alerts did not elicit changes in sedentary time over 12 months among recent retirees. Alternative approaches may be needed to achieve long-term changes in sedentary time among retirees. Clinical Trials registration Number: NCT03320746.",2022,"The use of an activity tracker did not reduce daily total or prolonged sedentary time over 12 months (p values for time*group interaction 0.27 and 0.39, respectively).","['231 retirees (mean age 65.2 (SD 1.1) years, 83% women', 'accelerometer-measured sedentary time among retirees']","['consumer-based activity tracker intervention', 'consumer-based wrist-worn activity tracker (Polar Loop 2, Polar, Kempele, Finland', 'activity tracker-based intervention']","['prolonged sedentary time', 'daily total and prolonged sedentary time', 'daily total or prolonged sedentary time']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0598862,"The use of an activity tracker did not reduce daily total or prolonged sedentary time over 12 months (p values for time*group interaction 0.27 and 0.39, respectively).","[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Suorsa', 'Affiliation': 'Department of Public Health, University of Turku and Turku University Hospital, Finland.'}, {'ForeName': 'Tuija', 'Initials': 'T', 'LastName': 'Leskinen', 'Affiliation': 'Department of Public Health, University of Turku and Turku University Hospital, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pulakka', 'Affiliation': 'Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Pentti', 'Affiliation': 'Department of Public Health, University of Turku and Turku University Hospital, Finland.'}, {'ForeName': 'Eliisa', 'Initials': 'E', 'LastName': 'Löyttyniemi', 'Affiliation': 'Department of Biostatistics, University of Turku and Turku University Hospital, Finland.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Heinonen', 'Affiliation': 'Turku PET Centre, and Department of Clinical Physiology and Nuclear Medicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Vahtera', 'Affiliation': 'Department of Public Health, University of Turku and Turku University Hospital, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Stenholm', 'Affiliation': 'Department of Public Health, University of Turku and Turku University Hospital, Finland.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glab107']
714,33846214,Effects of Message Framing on Cervical Cancer Screening Knowledge and Intentions Related to Primary HPV Testing.,"Numerous national guidelines now include primary human papillomavirus (HPV) testing as a recommended screening option for cervical cancer in the United States yet little is known regarding screening intentions for this specific screening strategy or interventions that may increase uptake. Gain- and loss-framed messaging can positively impact health behaviors; however, there is mixed evidence on which is more effective for cervical cancer screening, with no published evidence examining HPV testing. To help address this gap, this study compared the effects of message framing on screening knowledge and intentions related to primary HPV testing. We randomized females aged 21-65 ( n  = 365) to receive brief messaging about cervical cancer screening with either gain- or loss-framing. In January-February 2020, participants completed pretest and posttest measures evaluating cervical cancer knowledge, beliefs, and intentions to be screened using HPV testing. We used generalized estimating equations to model message and framing effects on screening outcomes, controlling for age, education, race, and baseline measures. In comparison to pretest, messaging significantly increased HPV-related screening intentions [adjusted OR (aOR): 2.4 (1-3.5)] and knowledge [aOR: 1.7 (1.2-2.4)], perceived effectiveness of HPV testing [aOR: 4.3 (2.8-6.5)], and preference for primary HPV screening [aOR: 3.2 (1.2-8.5)], regardless of message framing. For all outcomes, no significant interaction by message framing was observed. Brief public health messaging positively impacted HPV-related screening intentions, knowledge, and beliefs, independent of message framing. In conjunction with other strategies, these results suggest that messaging could be an effective tool to increase uptake of primary HPV testing. PREVENTION RELEVANCE: Primary HPV tests are more sensitive and offer greater reassurance than Pap tests alone yet use for routine cervical cancer screening remains low. Brief public health messaging can positively impact awareness, knowledge, and screening intention regarding primary HPV testing. Messaging campaigns paired with other strategies can increase uptake across populations. See related Spotlight, p. 823 .",2021,"In comparison to pretest, messaging significantly increased HPV-related screening intentions [aOR: 2.4 (1., 3.5)] and knowledge [aOR: 1.7 (1.2, 2.4)], perceived effectiveness of HPV testing [aOR: 4.3 (2.8, 6.5)], and preference for primary HPV screening [aOR: 3.2 (1.2, 8.5), regardless of message framing.",['females aged 21-65 (n=365) to receive'],"['brief messaging about cervical cancer screening with either gain- or loss-framing', 'Gain- and loss-framed messaging']","['HPV-related screening intentions', 'cervical cancer knowledge, beliefs, and intentions to be screened using HPV testing']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",,0.0377657,"In comparison to pretest, messaging significantly increased HPV-related screening intentions [aOR: 2.4 (1., 3.5)] and knowledge [aOR: 1.7 (1.2, 2.4)], perceived effectiveness of HPV testing [aOR: 4.3 (2.8, 6.5)], and preference for primary HPV screening [aOR: 3.2 (1.2, 8.5), regardless of message framing.","[{'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Ogden', 'Affiliation': 'Department of Health Law, Policy and Management, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Leskinen', 'Affiliation': 'School of Social Science and Human Services, Ramapo College of New Jersey, Mahwah, New Jersey.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sarma', 'Affiliation': 'Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Jocelyn V', 'Initials': 'JV', 'LastName': 'Wainwright', 'Affiliation': 'Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Katharine A', 'Initials': 'KA', 'LastName': 'Rendle', 'Affiliation': 'Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. katharine.rendle@pennmedicine.upenn.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0622']
715,33846198,FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma.,"The FDA approved pembrolizumab on June 29, 2020, for the treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) colorectal cancer with no prior systemic treatment for advanced disease. The approval was based on data from Study Keynote-177, which randomly allocated patients to receive either pembrolizumab or standard of care (SOC) with chemotherapy. Overall survival (OS) and independently assessed progression-free survival (PFS) were the primary endpoints. At the time of the final PFS analysis and second prespecified interim OS analysis, the estimated median PFS was 16.5 months (95% CI: 5.4-32.4) versus 8.2 months (95% CI: 6.1-10.2) in the pembrolizumab and SOC arms, respectively [HR: 0.60 (95% CI: 0.45-0.80); two-sided  P  = 0.0004]. FDA assessed unblinded OS data during the review of the application and identified no safety concerns that would preclude approval of this supplement. Adverse reactions occurring in >30% of patients receiving pembrolizumab were diarrhea, fatigue/asthenia, and nausea. Adverse reactions occurring in >30% of patients receiving SOC were diarrhea, nausea, fatigue/asthenia, neutropenia, decreased appetite, peripheral neuropathy (high-level term), vomiting, abdominal pain, constipation, and stomatitis. Duration of treatment in the pembrolizumab arm was almost double (median 11.1 months, range 0-30.6 months) than the duration of treatment in patients receiving SOC (median, 5.7 months). Approval of pembrolizumab is likely to change the treatment paradigm for first-line treatment with MSI-H advanced colorectal cancer given the study results and different safety profile.",2021,"Adverse reactions occurring in >30% of patients receiving SOC were diarrhea, nausea, fatigue/asthenia, neutropenia, decreased appetite, peripheral neuropathy (high-level term), vomiting, abdominal pain, constipation, and stomatitis.","['patients with unresectable or metastatic microsatellite instability-high (MSI-H) colorectal cancer (CRC) with no prior systemic treatment for advanced disease', 'patients with MSI-H/dMMR advanced unresectable or metastatic colorectal carcinoma']","['pembrolizumab or standard of care (SOC) with chemotherapy', 'pembrolizumab', 'Pembrolizumab']","['Overall survival (OS) and independently-assessed progression free survival (PFS', 'median PFS', 'diarrhea, nausea, fatigue/asthenia, neutropenia, decreased appetite, peripheral neuropathy (high-level term), vomiting, abdominal pain, constipation, and stomatitis', 'diarrhea, fatigue/asthenia, and nausea', 'Adverse reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0796369', 'cui_str': 'Microsatellite instability'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",,0.234237,"Adverse reactions occurring in >30% of patients receiving SOC were diarrhea, nausea, fatigue/asthenia, neutropenia, decreased appetite, peripheral neuropathy (high-level term), vomiting, abdominal pain, constipation, and stomatitis.","[{'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Casak', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. Sandra.Casak@fda.hhs.gov.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Marcus', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Fashoyin-Aje', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Sirisha L', 'Initials': 'SL', 'LastName': 'Mushti', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Yuan-Li', 'Initials': 'YL', 'LastName': 'Shen', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pierce', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Her', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Theoret', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Kluetz', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Lemery', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-0557']
716,33840531,"Effect of light-emitting diode-mediated photobiomodulation on extraction space closure in adolescents and young adults: A split-mouth, randomized controlled trial.","INTRODUCTION


This split-mouth trial aimed to examine the effects of light-emitting diode (LED)-mediated photobiomodulation compared with no photobiomodulation on maxillary canine distalization.
METHODS


Twenty participants (10 males and 10 females; aged 11-20 years) requiring bilateral extraction of maxillary first premolars were included from the Sydney Dental Hospital waiting list. After premolar extractions, leveling, and alignment, canines were retracted on 0.020-in stainless steel wires with coil springs delivering 150 g of force to each side. Each patient's right side was randomly assigned to experimental or control using www.randomisation.com, and allocation concealment was performed with sequentially numbered, opaque, sealed envelopes. The experimental side received 850 nm wavelength, 60 mW/cm 2  power, continuous LED with OrthoPulse device (Biolux Research Ltd, Vancouver, British Columbia, Canada) for 5 min/d. For the control side, the device was blocked with opaque black film. Patients were reviewed at 4-week intervals for force reactivation and intraoral scanning over 12 weeks. The primary outcome was the amount of tooth movement, and secondary outcomes were anchorage loss and canine rotation, all measured digitally. Blinding for study participants and the treating clinician was not possible; however, blinding was done for the measurements by deidentifying the digital scans. Linear mixed models were implemented for the data analysis.
RESULTS


Nineteen participants concluded the study. Data analysis showed that the treatment × time interaction was not significant, suggesting no difference in space closure (unstandardized regression coefficient [b], 0.12; 95% confidence interval [CI], -0.05 to 0.29; P = 0.17), canine rotation (b, 0.21; 95% CI, -0.82 to 1.25; P = 0.69), and anchorage loss (b, -0.01, 95% CI, -0.28 to 0.26, P = 0.94). No harms were noted.
CONCLUSIONS


Daily 5-minute application of LED did not result in clinically meaningful differences during extraction space closure compared with no LED application.
REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12616000652471).
PROTOCOL


The protocol was not published before trial commencement.
FUNDING


This research was funded by the Australian Society of Orthodontists Foundation for Research and Education.",2021,"CONCLUSIONS


Daily 5-minute application of LED did not result in clinically meaningful differences during extraction space closure compared with no LED application.
","['adolescents and young adults', 'Nineteen participants concluded the study', 'Twenty participants (10 males and 10 females; aged 11-20\xa0years) requiring\xa0bilateral extraction of maxillary first premolars were included from the Sydney Dental Hospital waiting list']","['light-emitting diode (LED)-mediated photobiomodulation', 'light-emitting diode-mediated photobiomodulation']","['extraction space closure', 'anchorage loss', 'space closure (unstandardized regression coefficient', 'canine rotation', 'amount of tooth movement, and secondary outcomes were anchorage loss and canine rotation, all measured digitally']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3164440', 'cui_str': 'Dental hospital'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040446', 'cui_str': 'Orthodontic Tooth Movement'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",19.0,0.405531,"CONCLUSIONS


Daily 5-minute application of LED did not result in clinically meaningful differences during extraction space closure compared with no LED application.
","[{'ForeName': 'Safa', 'Initials': 'S', 'LastName': 'Al-Shafi', 'Affiliation': 'Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, Faculty of Medicine and Health, The University of Sydney, Department of Orthodontics, Sydney Dental Hospital, Sydney South Local Health District, Australia.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Pandis', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, School of Dentistry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'M Ali', 'Initials': 'MA', 'LastName': 'Darendeliler', 'Affiliation': 'Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, Faculty of Medicine and Health, The University of Sydney, Department of Orthodontics, Sydney Dental Hospital, Sydney South Local Health District, Australia.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Papadopoulou', 'Affiliation': 'Discipline of Orthodontics and Paediatric Dentistry, School of Dentistry, Faculty of Medicine and Health, The University of Sydney, Department of Orthodontics, Sydney Dental Hospital, Sydney South Local Health District, Australia. Electronic address: alexandra.papadopoulou@sydney.edu.au.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2020.12.021']
717,33853071,Effects of Mental Imagery on Prospective Memory: A Process Analysis in Individuals with Amnestic Mild Cognitive Impairment.,"INTRODUCTION


Prospective memory (PM) is a multiphasic cognitive function important for autonomy and functional independence but is easily disrupted by pathological aging processes. Through cognitive simulation of perceptual experiences, mental imagery could be an effective compensatory strategy to enhance PM performance. Nevertheless, relevant research in individuals with amnestic mild cognitive impairment (MCI) has been limited, and the underlying mechanism of the therapeutic effect has not been sufficiently elucidated. The present study aimed to examine complex PM performances and the effect of mental imagery on each phase in older adults with MCI and to investigate the underlying cognitive mechanism from a process perspective.
METHODS


Twenty-eight MCI and 32 normal aging controls completed a seminaturalistic PM task, in addition to a series of neuropsychological tests. Participants from each group were randomly assigned to a mental imagery condition or a standard repeated encoding condition before performing the PM task. Four indices were used to measure performance in the intention formation, intention retention, intention initiation, and intention execution phases of PM. Performances in each phase was compared between the 2 diagnostic groups and the 2 instruction conditions.
RESULTS


The MCI group performed worse than the normal aging group in the intention formation and intention retention phases. The participants in the mental imagery condition performed significantly better than those in the standard condition during the intention formation, intention retention, and intention execution phases, regardless of the diagnostic group. Moreover, there was a significant interaction between the group and condition during intention retention, showing that people with MCI benefited even more from mental imagery than normal aging in this phase. Performance in the intention retention phase predicted performance in the intention initiation and intention execution phases.
DISCUSSION


PM deficits in MCI mainly manifest during planning and retaining intentions. Mental imagery was able to promote performance in all but the initiation phase, although a trend for improvement was observed in this phase. The effects of mental imagery may be exerted in the intention retention phase by strengthening the PM cue-action bond, thereby facilitating the probability of intention initiation and bolstering fidelity to the original plan during intention execution.",2021,"The participants in the mental imagery condition performed significantly better than those in the standard condition during the intention formation, intention retention, and intention execution phases, regardless of the diagnostic group.","['individuals with amnestic mild cognitive impairment (MCI', 'Prospective Memory', 'older adults with MCI', 'Individuals with Amnestic Mild Cognitive Impairment', 'Twenty-eight MCI and 32 normal aging controls completed a seminaturalistic PM task, in addition to a series of neuropsychological tests']","['mental imagery', 'mental imagery condition or a standard repeated encoding condition before performing the PM task', 'Mental Imagery', 'MCI']","['intention formation, intention retention, intention initiation, and intention execution phases of PM', 'intention formation, intention retention, and intention execution phases']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0589154', 'cui_str': 'Prospective memory'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0589154', 'cui_str': 'Prospective memory'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0589154', 'cui_str': 'Prospective memory'}]",4.0,0.0124031,"The participants in the mental imagery condition performed significantly better than those in the standard condition during the intention formation, intention retention, and intention execution phases, regardless of the diagnostic group.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Department of Psychiatry, Hsinchu MacKay Memorial Hospital, MacKay Medical Foundation, The Presbyterian Church in Taiwan, Hsinchu, Taiwan.'}, {'ForeName': 'Min-Chien', 'Initials': 'MC', 'LastName': 'Tu', 'Affiliation': 'Department of Neurology, Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taichung, Taiwan.'}, {'ForeName': 'Wen-Hui', 'Initials': 'WH', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taichung, Taiwan.'}, {'ForeName': 'Yen-Hsuan', 'Initials': 'YH', 'LastName': 'Hsu', 'Affiliation': 'Department of Psychology, National Chung Cheng University, Chiayi, Taiwan.'}]",Gerontology,['10.1159/000514869']
718,33852720,Growth Hormone Releasing Hormone Reduces Circulating Markers of Immune Activation in Parallel with Effects on Hepatic Immune Pathways in Individuals with HIV-infection and Nonalcoholic Fatty Liver Disease.,"BACKGROUND


The growth hormone (GH)/insulin-like growth factor-1 (IGF-1) axis modulates critical metabolic pathways; however, little is known regarding effects of augmenting pulsatile GH secretion on immune function in humans. This study used proteomics and gene set enrichment analysis to assess effects of a GH releasing hormone (GHRH) analog, tesamorelin, on circulating immune markers and liver tissue in people with human immunodeficiency virus (HIV) (PWH) and nonalcoholic fatty liver disease (NAFLD).
METHODS


92 biomarkers associated with immunity, chemotaxis, and metabolism were measured in plasma samples from 61 PWH with NAFLD who participated in a double-blind, randomized trial of tesamorelin versus placebo for 12 months. Gene set enrichment analysis was performed on serial liver biopsies targeted to immune pathways.
RESULTS


Tesamorelin, compared to placebo, decreased interconnected proteins related to cytotoxic T-cell and monocyte activation. Circulating concentrations of 13 proteins were significantly decreased, and no proteins increased, by tesamorelin. These included 4 chemokines (CCL3, CCL4, CCL13 [MCP4], IL8 [CXCL8]), 2 cytokines (IL-10 and CSF-1), and 4 T-cell associated molecules (CD8A, CRTAM, GZMA, ADGRG1), as well as ARG1, Gal-9, and HGF. Network analysis indicated close interaction among the gene pathways responsible for these proteins, with imputational analyses suggesting down-regulation of a closely related cluster of immune pathways. Targeted transcriptomics using liver tissue confirmed a significant end-organ signal of down-regulated immune activation pathways.
CONCLUSIONS


Long-term treatment with a GHRH analog reduced markers of T-cell and monocyte/macrophage activity, suggesting that augmentation of the GH axis may ameliorate immune activation in an HIV population with metabolic dysregulation, systemic and end organ inflammation. Clinical Trials Registration. NCT02196831.",2021,"Circulating concentrations of 13 proteins were significantly decreased, and no proteins increased, by tesamorelin.","['92 biomarkers associated with immunity, chemotaxis, and metabolism were measured in plasma samples from 61 PWH with NAFLD who participated in a double-blind, randomized trial of', 'people with HIV (PWH) and NAFLD', 'Individuals with HIV-Infection and Nonalcoholic Fatty Liver Disease']","['GH releasing hormone (GHRH) analog, tesamorelin', 'placebo', 'tesamorelin versus placebo', 'Growth Hormone Releasing Hormone']","['cytotoxic T-cell and monocyte activation', 'Circulating concentrations of 13 proteins', 'chemokines (CCL3, CCL4, CCL13 [MCP4], IL8 [CXCL8]), two cytokines (IL-10 and CSF-1), and four T-cell associated molecules (CD8A, CRTAM, GZMA, ADGRG1), as well as ARG1, Gal-9, and HGF']","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}]","[{'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C1876200', 'cui_str': 'tesamorelin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039195', 'cui_str': 'Cytotoxic T lymphocyte'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C1871788', 'cui_str': 'CCL3 protein, human'}, {'cui': 'C0007022', 'cui_str': 'Carbon tetrachloride'}, {'cui': 'C0390071', 'cui_str': 'chemokine (C-C motif) ligand 13, human'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0914468', 'cui_str': 'class-I restricted T cell-associated molecule'}, {'cui': 'C0766915', 'cui_str': 'GPR56 protein, human'}, {'cui': 'C0537111', 'cui_str': 'LGALS9 protein, human'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",13.0,0.278888,"Circulating concentrations of 13 proteins were significantly decreased, and no proteins increased, by tesamorelin.","[{'ForeName': 'Takara L', 'Initials': 'TL', 'LastName': 'Stanley', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Lindsay T', 'Initials': 'LT', 'LastName': 'Fourman', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Lai Ping', 'Initials': 'LP', 'LastName': 'Wong', 'Affiliation': 'Department of Molecular Biology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Sadreyev', 'Affiliation': 'Department of Molecular Biology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Billingsley', 'Affiliation': 'Harvard Chan Bioinformatics Core, Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Meghan N', 'Initials': 'MN', 'LastName': 'Feldpausch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Zheng', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Chelsea S', 'Initials': 'CS', 'LastName': 'Pan', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Boutin', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Corey', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Torriani', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kleiner', 'Affiliation': 'Laboratory of Pathology, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Chung', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Hadigan', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Massachusetts, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciab019']
719,33858390,"Effect of various dialysis modalities on intradialytic hemodynamics, tissue injury and patient discomfort in chronic dialysis patients: design of a randomized cross-over study (HOLLANT).","BACKGROUND


From a recent meta-analysis it appeared that online post-dilution hemodiafiltration (HDF), especially with a high convection volume (HV-HDF), is associated with superior overall and cardiovascular survival, if compared to standard hemodialysis (HD). The mechanism(s) behind this effect, however, is (are) still unclear. In this respect, a lower incidence of intradialytic hypotension (IDH), and hence less tissue injury, may play a role. To address these items, the HOLLANT study was designed.
METHODS


HOLLANT is a Dutch multicentre randomized controlled cross-over trial. In total, 40 prevalent dialysis patients will be included and, after a run-in phase, exposed to standard HD, HD with cooled dialysate, low-volume HDF and high-volume HDF (Dialog iQ® machine) in a randomized fashion. The primary endpoint is an intradialytic nadir in systolic blood pressure (SBP) of < 90 and < 100 mmHg for patients with predialysis SBP < 159 and ≥ 160 mmHg, respectively. The main secondary outcomes are 1) intradialytic left ventricle (LV) chamber quantification and deformation, 2) intradialytic hemodynamic profile of SBP, diastolic blood pressure (DBP), mean arterial pressure (MAP) and pulse pressure (PP), 3) organ and tissue damage, such as the release of specific cellular components, and 4) patient reported symptoms and thermal perceptions during each modality.
DISCUSSION


The current trial is primarily designed to test the hypothesis that a lower incidence of intradialytic hypotension contributes to the superior survival of (HV)-HDF. A secondary objective of this investigation is the question whether changes in the intradialytic blood pressure profile correlate with organ dysfunction and tissue damage, and/or patient discomfort.
TRIAL REGISTRATION


Registered Report Identifier: NCT03249532 # ( ClinicalTrials.gov ). Date of registration: 2017/08/15.",2021,"In this respect, a lower incidence of intradialytic hypotension (IDH), and hence less tissue injury, may play a role.","['40 prevalent dialysis patients', 'chronic dialysis patients']","['various dialysis modalities', 'standard HD, HD with cooled dialysate, low-volume HDF and high-volume HDF (Dialog iQ® machine']","['intradialytic nadir in systolic blood pressure (SBP', 'intradialytic hemodynamics, tissue injury and patient discomfort', '1) intradialytic left ventricle (LV) chamber quantification and deformation, 2) intradialytic hemodynamic profile of SBP, diastolic blood pressure (DBP), mean arterial pressure (MAP) and pulse pressure (PP), 3) organ and tissue damage, such as the release of specific cellular components, and 4) patient reported symptoms and thermal perceptions during each modality', 'intradialytic hypotension (IDH']","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336779', 'cui_str': 'Machine'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C4552279', 'cui_str': 'Tissue injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007799', 'cui_str': 'Brain ventricle structure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",,0.0842744,"In this respect, a lower incidence of intradialytic hypotension (IDH), and hence less tissue injury, may play a role.","[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Rootjes', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam UMC, VU University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Menso J', 'Initials': 'MJ', 'LastName': 'Nubé', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam UMC, VU University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Camiel L M', 'Initials': 'CLM', 'LastName': 'de Roij van Zuijdewijn', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam UMC, VU University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Gertrude', 'Initials': 'G', 'LastName': 'Wijngaarden', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam UMC, VU University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Muriel P C', 'Initials': 'MPC', 'LastName': 'Grooteman', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences (ACS), Amsterdam UMC, VU University of Amsterdam, Amsterdam, The Netherlands. mpc.grooteman@amsterdamumc.nl.'}]",BMC nephrology,['10.1186/s12882-021-02331-z']
720,34379922,Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women.,"BACKGROUND


Safe and effective long-acting injectable agents for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection are needed to increase the options for preventing HIV infection.
METHODS


We conducted a randomized, double-blind, double-dummy, noninferiority trial to compare long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor [INSTI]) at a dose of 600 mg, given intramuscularly every 8 weeks, with daily oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) for the prevention of HIV infection in at-risk cisgender men who have sex with men (MSM) and in at-risk transgender women who have sex with men. Participants were randomly assigned (1:1) to receive one of the two regimens and were followed for 153 weeks. HIV testing and safety evaluations were performed. The primary end point was incident HIV infection.
RESULTS


The intention-to-treat population included 4566 participants who underwent randomization; 570 (12.5%) identified as transgender women, and the median age was 26 years (interquartile range, 22 to 32). The trial was stopped early for efficacy on review of the results of the first preplanned interim end-point analysis. Among 1698 participants from the United States, 845 (49.8%) identified as Black. Incident HIV infection occurred in 52 participants: 13 in the cabotegravir group (incidence, 0.41 per 100 person-years) and 39 in the TDF-FTC group (incidence, 1.22 per 100 person-years) (hazard ratio, 0.34; 95% confidence interval, 0.18 to 0.62). The effect was consistent across prespecified subgroups. Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF-FTC group. In the participants in whom HIV infection was diagnosed after exposure to CAB-LA, INSTI resistance and delays in the detection of HIV infection were noted. No safety concerns were identified.
CONCLUSIONS


CAB-LA was superior to daily oral TDF-FTC in preventing HIV infection among MSM and transgender women. Strategies are needed to prevent INSTI resistance in cases of CAB-LA PrEP failure. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 083 ClinicalTrials.gov number, NCT02720094.).",2021,Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF-FTC group.,"['4566 participants who underwent randomization; 570 (12.5%) identified as transgender women, and the median age was 26 years (interquartile range, 22 to 32', '1698 participants from the United States, 845 (49.8%) identified as Black', 'human immunodeficiency virus', 'Cisgender Men and Transgender Women', 'at-risk cisgender men who have sex with men (MSM) and in at-risk transgender women who have sex with men']","['long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor [INSTI', 'tenofovir disoproxil fumarate-emtricitabine (TDF-FTC', 'TDF-FTC']","['Incident HIV infection', 'Injection-site reactions', 'incident HIV infection', 'HIV testing and safety evaluations']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0376601', 'cui_str': 'Integrase strand transfer inhibitor-containing product'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}]","[{'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",4566.0,0.621575,Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF-FTC group.,"[{'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'Landovitz', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'Clement', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Hanscom', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cottle', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Coelho', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Cabello', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Suwat', 'Initials': 'S', 'LastName': 'Chariyalertsak', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Eileen F', 'Initials': 'EF', 'LastName': 'Dunne', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Frank', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Gallardo-Cartagena', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Aditya H', 'Initials': 'AH', 'LastName': 'Gaur', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gonzales', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Ha V', 'Initials': 'HV', 'LastName': 'Tran', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Hinojosa', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Esper G', 'Initials': 'EG', 'LastName': 'Kallas', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Colleen F', 'Initials': 'CF', 'LastName': 'Kelley', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Marcelo H', 'Initials': 'MH', 'LastName': 'Losso', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'J Valdez', 'Initials': 'JV', 'LastName': 'Madruga', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Middelkoop', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Nittaya', 'Initials': 'N', 'LastName': 'Phanuphak', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Breno', 'Initials': 'B', 'LastName': 'Santos', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Sued', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Valencia Huamaní', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Swaminathan', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Del Rio', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Gulick', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Sullivan', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Piwowar-Manning', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Marzinke', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Hendrix', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Maoji', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Marrazzo', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Daar', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Asmelash', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Anderson', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Eshleman', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bryan', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Blanchette', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lucas', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Psaros', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Safren', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Sugarman', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Hyman', 'Initials': 'H', 'LastName': 'Scott', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Eron', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Sheldon D', 'Initials': 'SD', 'LastName': 'Fields', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Nirupama D', 'Initials': 'ND', 'LastName': 'Sista', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Kailazarid', 'Initials': 'K', 'LastName': 'Gomez-Feliciano', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jennings', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Kofron', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Holtz', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Shin', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Rooney', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Smith', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Spreen', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margolis', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rinehart', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Adeola', 'Initials': 'A', 'LastName': 'Adeyeye', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Marybeth', 'Initials': 'M', 'LastName': 'McCauley', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': ""From the Center for Clinical AIDS Research and Education, David Geffen School of Medicine, University of California, Los Angeles (R.J.L., R.M.K.),\xa0the Lundquist Institute at Harbor-UCLA Medical Center, Torrance (E.D.),\xa0the San Francisco Department of Public Health, San Francisco (H.S.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the Fred Hutchinson Cancer Research Center, Seattle (D.D., B.H., L. Cottle, M.L., Z.W.); the Louisiana State University Health Sciences Center, New Orleans (M.E.C.); Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro (L. Coelho, B.G.), University of São Paulo (E.G.K.), and Centro de Referência e Treinamento DST-AIDS-SP (J.V.M.), São Paulo, and Hospital Nossa Senhora da Conceição, Porto Alegre (B.S.) - all in Brazil; Via Libre (R.C.), Universidad Nacional Mayor de San Marcos (J.A.G.-C.), and Asociacion Civil Impacta Salud y Educacion (P.G., J.V.H.), Lima, and Asociacion Civil Selva Amazonica, Iquitos (J.C.H.) - all in Peru; the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai (S.C.), and the Institute of HIV Research and Innovation, Bangkok (N.P.) - both in Thailand; the Division of HIV-AIDS Prevention, Centers for Disease Control and Prevention (E.F.D.), the School of Medicine (C.F.K., C.R.), and Rollins School of Public Health (C.R.), Emory University - both in Atlanta; the Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.), and Pennsylvania State University, State College (S.D.F.) - both in Pennsylvania; St. Jude Children's Research Hospital, Memphis, TN (A.H.G.); University of North Carolina at Chapel Hill, Chapel Hill (H.V.T., J.J.E., M.S.C.), FHI 360, Durham (A. Asmelash, M.B., C.B., J.L., N.D.S., K.G.-F., A.J., M.M.), and ViiV Healthcare, Research Triangle (K.Y.S., W.S., D.M., A.R.) - all in North Carolina; Hospital General de Agudos José María Ramos Mejia (M.H.L.) and Fundación Huésped (O.S.) - both in Buenos Aires; the Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (K.M.); University of Alabama at Birmingham, Birmingham (E.T.O., J.M.); Rutgers New Jersey Medical School, Newark (S. Swaminathan); Weill Cornell Medicine, New York (R.M.G.); Johns Hopkins University, Baltimore (P.R., P.S., E.P.-M., M.M., C.H., T.T.B., S.H.E., J.S.); University of Colorado Anschutz Medical Campus, Aurora (P.A.); Massachusetts General Hospital, Boston (C.P.); University of Miami, Coral Gables, FL (S. Safren); the Office of AIDS Research (T.H.H.) and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD (K.S., A. Adeyeye).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2101016']
721,34379916,A Monoclonal Antibody for Malaria Prevention.,"BACKGROUND


Additional interventions are needed to reduce the morbidity and mortality caused by malaria.
METHODS


We conducted a two-part, phase 1 clinical trial to assess the safety and pharmacokinetics of CIS43LS, an antimalarial monoclonal antibody with an extended half-life, and its efficacy against infection with  Plasmodium falciparum . Part A of the trial assessed the safety, initial side-effect profile, and pharmacokinetics of CIS43LS in healthy adults who had never had malaria. Participants received CIS43LS subcutaneously or intravenously at one of three escalating dose levels. A subgroup of participants from Part A continued to Part B, and some received a second CIS43LS infusion. Additional participants were enrolled in Part B and received CIS43LS intravenously. To assess the protective efficacy of CIS43LS, some participants underwent controlled human malaria infection in which they were exposed to mosquitoes carrying  P. falciparum  sporozoites 4 to 36 weeks after administration of CIS43LS.
RESULTS


A total of 25 participants received CIS43LS at a dose of 5 mg per kilogram of body weight, 20 mg per kilogram, or 40 mg per kilogram, and 4 of the 25 participants received a second dose (20 mg per kilogram regardless of initial dose). No safety concerns were identified. We observed dose-dependent increases in CIS43LS serum concentrations, with a half-life of 56 days. None of the 9 participants who received CIS43LS, as compared with 5 of 6 control participants who did not receive CIS43LS, had parasitemia according to polymerase-chain-reaction testing through 21 days after controlled human malaria infection. Two participants who received 40 mg per kilogram of CIS43LS and underwent controlled human malaria infection approximately 36 weeks later had no parasitemia, with serum concentrations of CIS43LS of 46 and 57 μg per milliliter at the time of controlled human malaria infection.
CONCLUSIONS


Among adults who had never had malaria infection or vaccination, administration of the long-acting monoclonal antibody CIS43LS prevented malaria after controlled infection. (Funded by the National Institute of Allergy and Infectious Diseases; VRC 612 ClinicalTrials.gov number, NCT04206332.).",2021,No safety concerns were identified.,"['participants underwent controlled human malaria infection in which they were exposed to mosquitoes carrying  P. falciparum  sporozoites 4 to 36 weeks after administration of CIS43LS', 'adults who had never had malaria infection or vaccination, administration of the long-acting monoclonal antibody CIS43LS prevented malaria after controlled infection', 'healthy adults who had never had malaria']","['40 mg per kilogram of CIS43LS', 'CIS43LS', 'CIS43LS subcutaneously']",['CIS43LS serum concentrations'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0562648', 'cui_str': 'Kingdom Protozoa sporozoite'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0439209', 'cui_str': 'kg'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",2.0,0.393783,No safety concerns were identified.,"[{'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Gaudinski', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Nina M', 'Initials': 'NM', 'LastName': 'Berkowitz', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Azza H', 'Initials': 'AH', 'LastName': 'Idris', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Coates', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'LaSonji A', 'Initials': 'LA', 'LastName': 'Holman', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Floreliz', 'Initials': 'F', 'LastName': 'Mendoza', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Ingelise J', 'Initials': 'IJ', 'LastName': 'Gordon', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Plummer', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Trofymenko', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Zonghui', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Andrezza', 'Initials': 'A', 'LastName': 'Campos Chagas', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': ""O'Connell"", 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Basappa', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Douek', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Sandeep R', 'Initials': 'SR', 'LastName': 'Narpala', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Barry', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Alicia T', 'Initials': 'AT', 'LastName': 'Widge', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Renunda', 'Initials': 'R', 'LastName': 'Hicks', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Seemal F', 'Initials': 'SF', 'LastName': 'Awan', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Wu', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Somia', 'Initials': 'S', 'LastName': 'Hickman', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Wycuff', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Stein', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Case', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Evans', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Carlton', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Gall', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Vazquez', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Flach', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Chen', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Francica', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Flynn', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Neville K', 'Initials': 'NK', 'LastName': 'Kisalu', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'McDermott', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Ledgerwood', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Seder', 'Affiliation': 'From the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2034031']
722,33888247,Patient Selection for Intensive Blood Pressure Management Based on Benefit and Adverse Events.,"BACKGROUND


Intensive systolic blood pressure (SBP) treatment prevents cardiovascular disease (CVD) events in patients with high CVD risk on average, though benefits likely vary among patients.
OBJECTIVES


The aim of this study was to predict the magnitude of benefit (reduced CVD and all-cause mortality risk) along with adverse event (AE) risk from intensive versus standard SBP treatment.
METHODS


This was a secondary analysis of SPRINT (Systolic Blood Pressure Intervention Trial). Separate benefit outcomes were the first occurrence of: 1) a CVD composite of acute myocardial infarction or other acute coronary syndrome, stroke, heart failure, or CVD death; and 2) all-cause mortality. Treatment-related AEs of interest included hypotension, syncope, bradycardia, electrolyte abnormalities, injurious falls, and acute kidney injury. Modified elastic net Cox regression was used to predict absolute risk for each outcome and absolute risk differences on the basis of 36 baseline variables available at the point of care with intensive versus standard treatment.
RESULTS


Among 8,828 SPRINT participants (mean age 67.9 years, 35% women), 600 CVD composite events, 363 all-cause deaths, and 481 treatment-related AEs occurred over a median follow-up period of 3.26 years. Individual participant risks were predicted for the CVD composite (C index = 0.71), all-cause mortality (C index = 0.75), and treatment-related AEs (C index = 0.69). Higher baseline CVD risk was associated with greater benefit (i.e., larger absolute CVD risk reduction). Predicted CVD benefit and predicted increased treatment-related AE risk were correlated (Spearman correlation coefficient = -0.72), and 95% of participants who fell into the highest tertile of predicted benefit also had high or moderate predicted increases in treatment-related AE risk. Few were predicted as high benefit with low AE risk (1.8%) or low benefit with high AE risk (1.5%). Similar results were obtained for all-cause mortality.
CONCLUSIONS


SPRINT participants with higher baseline predicted CVD risk gained greater absolute benefit from intensive treatment. Participants with high predicted benefit were also most likely to experience treatment-related AEs, but AEs were generally mild and transient. Patients should be prioritized for intensive SBP treatment on the basis of higher predicted benefit. (Systolic Blood Pressure Intervention Trial [SPRINT]; NCT01206062).",2021,"Individual participant risks were predicted for the CVD composite (C index = 0.71), all-cause mortality (C index = 0.75), and treatment-related AEs (C index = 0.69).","['8,828 SPRINT participants (mean age 67.9 years, 35% women', 'patients with high CVD risk']",['Intensive systolic blood pressure (SBP'],"['hypotension, syncope, bradycardia, electrolyte abnormalities, injurious falls, and acute kidney injury', 'treatment-related AE risk', 'cardiovascular disease (CVD) events', 'CVD composite of acute myocardial infarction or other acute coronary syndrome, stroke, heart failure, or CVD death; and 2) all-cause mortality']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0151613', 'cui_str': 'Electrolytes abnormal'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",8828.0,0.305998,"Individual participant risks were predicted for the CVD composite (C index = 0.71), all-cause mortality (C index = 0.75), and treatment-related AEs (C index = 0.69).","[{'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Bress', 'Affiliation': 'Department of Population Health Sciences, University of Utah, Salt Lake City, Utah, USA. Electronic address: adam.bress@hsc.utah.edu.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Department of Population Health Sciences, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Catherine G', 'Initials': 'CG', 'LastName': 'Derington', 'Affiliation': 'Department of Population Health Sciences, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Jincheng', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Department of Population Health Sciences, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Yizhe', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Population Health Sciences, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Yiyi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Division of General Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ying', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Brandon K', 'Initials': 'BK', 'LastName': 'Bellows', 'Affiliation': 'Division of General Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA; Medical Service, Memphis VA Medical Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana, USA.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reboussin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddu', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hess', 'Affiliation': 'Department of Population Health Sciences, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Herrick', 'Affiliation': 'Department of Population Health Sciences, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Zugui', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Christiana Care Health System, Newark, Delaware, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kolm', 'Affiliation': 'MedStar Health Research Institute, Washington, District of Columbia, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Yeh', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Research and Analytics, Collective Health, San Francisco, California, USA; Center for Primary Care, Harvard Medical School, Boston, Massachusetts, USA; School of Public Health, Imperial College, London, United Kingdom.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Weintraub', 'Affiliation': 'MedStar Health Research Institute, Washington, District of Columbia, USA; Department of Medicine, Georgetown University, Washington, District of Columbia, USA.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Moran', 'Affiliation': 'Division of General Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2021.02.058']
723,33858855,"Effects of the SGLT2 Inhibitor Dapagliflozin on Energy Metabolism in Patients With Type 2 Diabetes: A Randomized, Double-Blind Crossover Trial.","OBJECTIVE


SGTL2 inhibitors increase urinary glucose excretion and have beneficial effects on cardiovascular and renal outcomes. The underlying mechanism may involve caloric restriction-like metabolic effects due to urinary glucose loss. We investigated the effects of dapagliflozin on 24-h energy metabolism and insulin sensitivity in patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS


There were 26 patients with type 2 diabetes randomized to a 5-week double-blind, crossover study with a 6- to 8-week washout. Indirect calorimetry was used to measure 24-h energy metabolism and the respiratory exchange ratio (RER), both by whole-room calorimetry and by ventilated hood during a two-step euglycemic-hyperinsulinemic clamp. Results are presented as the differences in least squares mean (95% CI) between treatments.
RESULTS


Evaluable patients ( n  = 24) had a mean (SD) age of 64.2 (4.6) years, BMI of 28.1 (2.4) kg/m 2 , and HbA 1c  of 6.9% (0.7) (51.7 [6.8] mmol/mol). Rate of glucose disappearance was unaffected by dapagliflozin, whereas fasting endogenous glucose production (EGP) increased by dapagliflozin (+2.27 [1.39, 3.14] μmol/kg/min,  P  < 0.0001). Insulin-induced suppression of EGP (-1.71 [-2.75, -0.63] μmol/kg/min,  P  = 0.0036) and plasma free fatty acids (-21.93% [-39.31, -4.54],  P  = 0.016) was greater with dapagliflozin. Twenty-four-hour energy expenditure (-0.11 [-0.24, 0.03] MJ/day) remained unaffected by dapagliflozin, but dapagliflozin reduced the RER during daytime and nighttime, resulting in an increased day-to-nighttime difference in the RER (-0.010 [-0.017, -0.002],  P  = 0.016). Dapagliflozin treatment resulted in a negative 24-h energy and fat balance (-20.51 [-27.90, -13.12] g/day).
CONCLUSIONS


Dapagliflozin treatment for 5 weeks resulted in major adjustments of metabolism mimicking caloric restriction, increased fat oxidation, improved hepatic and adipose insulin sensitivity, and improved 24-h energy metabolism.",2021,"Insulin-induced suppression of EGP (-1.71 [-2.75, -0.63] μmol/kg/min,  P  = 0.0036) and plasma free fatty acids (-21.93% [-39.31, -4.54],  P  = 0.016) was greater with dapagliflozin.","['26 patients with type 2 diabetes', 'Evaluable patients ( n  = 24) had a mean (SD) age of 64.2 (4.6) years, BMI of 28.1 (2.4) kg/m 2 , and HbA 1c  of 6.9% (0.7) (51.7 [6.8] mmol/mol', 'Patients With Type 2 Diabetes', 'patients with type 2 diabetes']","['dapagliflozin', 'SGLT2 Inhibitor Dapagliflozin', 'Dapagliflozin']","['RER during daytime and nighttime, resulting in an increased day-to-nighttime difference in the RER', '24-h energy metabolism and insulin sensitivity', 'negative 24-h energy and fat balance', 'Rate of glucose disappearance', 'Insulin-induced suppression of EGP', '24-h energy metabolism and the respiratory exchange ratio (RER', 'metabolism mimicking caloric restriction, increased fat oxidation, improved hepatic and adipose insulin sensitivity, and improved 24-h energy metabolism', 'urinary glucose excretion', 'fasting endogenous glucose production (EGP', 'Energy Metabolism', 'plasma free fatty acids']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}]","[{'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0903677', 'cui_str': 'TACSTD1 protein, human'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}]",26.0,0.175956,"Insulin-induced suppression of EGP (-1.71 [-2.75, -0.63] μmol/kg/min,  P  = 0.0036) and plasma free fatty acids (-21.93% [-39.31, -4.54],  P  = 0.016) was greater with dapagliflozin.","[{'ForeName': 'Yvo J M', 'Initials': 'YJM', 'LastName': 'Op den Kamp', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'de Ligt', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Dautzenberg', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kornips', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Esterline', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Matthijs K C', 'Initials': 'MKC', 'LastName': 'Hesselink', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Hoeks', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Vera B', 'Initials': 'VB', 'LastName': 'Schrauwen-Hinderling', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Havekes', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oscarsson', 'Affiliation': 'BioPharmaceuticals R&D, Late-Stage Development, Cardiovascular, Renal and Metabolism, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Phielix', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands p.schrauwen@maastrichtuniversity.nl.'}]",Diabetes care,['10.2337/dc20-2887']
724,33883196,Dasiglucagon: A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia Results of Phase 3 Randomized Double-Blind Clinical Trial.,,2021,,[],['Dasiglucagon'],[],[],[],[],,0.632392,,"[{'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Medical University of Graz, Graz, Austria thomas.pieber@meduigraz.at.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes and Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Hövelmann', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Willard', 'Affiliation': 'ProSciento, San Diego, CA.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil, Mainz, Germany.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Knudsen', 'Affiliation': 'Zealand Pharma, Søborg, Denmark.'}, {'ForeName': 'Benedikte', 'Initials': 'B', 'LastName': 'Bandak', 'Affiliation': 'Zealand Pharma, Søborg, Denmark.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tehranchi', 'Affiliation': 'Zealand Pharma, Søborg, Denmark.'}]",Diabetes care,['10.2337/DC20-2995']
725,33871015,Daily Motivational Text Messages to Promote Physical Activity in University Students: Results From a Microrandomized Trial.,"BACKGROUND


Low physical activity is an important risk factor for common physical and mental disorders. Physical activity interventions delivered via smartphones can help users maintain and increase physical activity, but outcomes have been mixed.
PURPOSE


Here we assessed the effects of sending daily motivational and feedback text messages in a microrandomized clinical trial on changes in physical activity from one day to the next in a student population.
METHODS


We included 93 participants who used a physical activity app, ""DIAMANTE"" for a period of 6 weeks. Every day, their phone pedometer passively tracked participants' steps. They were microrandomized to receive different types of motivational messages, based on a cognitive-behavioral framework, and feedback on their steps. We used generalized estimation equation models to test the effectiveness of feedback and motivational messages on changes in steps from one day to the next.
RESULTS


Sending any versus no text message initially resulted in an increase in daily steps (729 steps, p = .012), but this effect decreased over time. A multivariate analysis evaluating each text message category separately showed that the initial positive effect was driven by the motivational messages though the effect was small and trend-wise significant (717 steps; p = .083), but not the feedback messages (-276 steps, p = .4).
CONCLUSION


Sending motivational physical activity text messages based on a cognitive-behavioral framework may have a positive effect on increasing steps, but this decreases with time. Further work is needed to examine using personalization and contextualization to improve the efficacy of text-messaging interventions on physical activity outcomes.
CLINICALTRIALS.GOV IDENTIFIER


NCT04440553.",2022,"Sending any versus no text message initially resulted in an increase in daily steps (729 steps, p = .012), but this effect decreased over time.","['University Students', '93 participants who used a physical activity app, ""DIAMANTE"" for a period of 6 weeks']","['Daily Motivational Text Messages', 'sending daily motivational and feedback text messages']","['physical activity', 'daily steps']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",93.0,0.0251757,"Sending any versus no text message initially resulted in an increase in daily steps (729 steps, p = .012), but this effect decreased over time.","[{'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Figueroa', 'Affiliation': 'School of Social Welfare, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Deliu', 'Affiliation': 'Department of Statistical Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Bibhas', 'Initials': 'B', 'LastName': 'Chakraborty', 'Affiliation': 'Centre for Quantitative Medicine and Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Arghavan', 'Initials': 'A', 'LastName': 'Modiri', 'Affiliation': 'Department of Computer Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Centre for Quantitative Medicine and Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Jai', 'Initials': 'J', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Computer Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Jay Williams', 'Affiliation': 'Department of Computer Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Lyles', 'Affiliation': 'UCSF Center for Vulnerable Populations, Zuckerberg San Francisco General Hospital, San Francisco, CA, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Aguilera', 'Affiliation': 'School of Social Welfare, University of California, Berkeley, CA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaab028']
726,32535124,Acute Kidney Function Declines in the Context of Decongestion in Acute Decompensated Heart Failure.,"OBJECTIVES


This study aimed to examine whether incorporation of a comprehensive set of measures of decongestion modifies the association of acute declines in kidney function with outcomes.
BACKGROUND


In-hospital acute declines in kidney function occur in approximately 20% to 30% of patients admitted with acute decompensated heart failure (ADHF) and may be associated with adverse outcomes.
METHODS


Using data from EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan), we used multivariable Cox regression models to evaluate the association between in-hospital changes in estimated glomerular filtration rate (eGFR) with death and a composite outcome of cardiovascular death and hospitalization for heart failure. We evaluated eGFR declines within the context of changes in markers of volume overload including b-type natriuretic peptide (BNP), N-terminal prohormone of B-type natriuretic peptide (NT-proBNP), and weight, as well as changes in measures of hemoconcentration including hematocrit, albumin, and total protein.
RESULTS


Among 3,715 patients over a median follow-up of 9.9 months, every 30% decline in eGFR was associated with higher risk of both death (hazard ratio [HR]: 1.19; 95% confidence interval [CI]: 1.07 to 1.31) and the composite outcome (HR: 1.09; 95% CI: 1.01 to 1.18) in adjusted models. The acute decline in eGFR was no longer associated with higher risk of either outcome as long as there was evidence of decongestion, either by declines in BNP, NT-proBNP, or weight or by increases in hematocrit, albumin or total protein. Interaction testing between decline in eGFR and changes in hematocrit, albumin, and total protein was statistically significant (p interaction of <0.01 for death and p interaction of ≤0.01 for composite for all 3 biomarkers). Interaction between change in eGFR and changes in BNP (p interaction = 0.07 for death; p interaction = 0.08 for composite), NT-proBNP (p interaction = 0.15 for death; p interaction = 0.18 for composite) and weight (p interaction = 0.13 for death; p interaction = 0.19 for composite) did not meet statistical significance.
CONCLUSIONS


Overall, acute declines in eGFR are associated with adverse outcomes, with evidence of modification by changes in markers of decongestion, suggesting that they are no longer associated with adverse outcomes if these markers are concomitantly improving.",2020,"Interaction testing between decline in eGFR and changes in hematocrit, albumin, and total protein was statistically significant (p interaction of <0.01 for death and p interaction of ≤0.01 for composite for all 3 biomarkers).","['3,715 patients over a median follow-up of 9.9\xa0months', 'Acute Decompensated Heart Failure', 'patients admitted with acute decompensated heart failure (ADHF']",['Tolvaptan'],"['hematocrit, albumin, and total protein', 'BNP', 'BNP, NT-proBNP, or weight or by increases in hematocrit, albumin or total protein', 'glomerular filtration rate (eGFR) with death and a composite outcome of cardiovascular death and hospitalization for heart failure', 'eGFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}]","[{'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0301817', 'cui_str': 'Prohormone'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0239935', 'cui_str': 'Haematocrit increased'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",3715.0,0.331182,"Interaction testing between decline in eGFR and changes in hematocrit, albumin, and total protein was statistically significant (p interaction of <0.01 for death and p interaction of ≤0.01 for composite for all 3 biomarkers).","[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'McCallum', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Hocine', 'Initials': 'H', 'LastName': 'Tighiouart', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Testani', 'Affiliation': 'Division of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'Division of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Marvin A', 'Initials': 'MA', 'LastName': 'Konstam', 'Affiliation': 'Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Udelson', 'Affiliation': 'Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sarnak', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts. Electronic address: msarnak@tuftsmedicalcenter.org.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.03.009']
727,33887208,"Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial.","BACKGROUND


Given the scale of the ongoing COVID-19 pandemic, the development of vaccines based on different platforms is essential, particularly in light of emerging viral variants, the absence of information on vaccine-induced immune durability, and potential paediatric use. We aimed to assess the safety and immunogenicity of an MF59-adjuvanted subunit vaccine for COVID-19 based on recombinant SARS-CoV-2 spike glycoprotein stabilised in a pre-fusion conformation by a novel molecular clamp (spike glycoprotein-clamp [sclamp]).
METHODS


We did a phase 1, double-blind, placebo-controlled, block-randomised trial of the sclamp subunit vaccine in a single clinical trial site in Brisbane, QLD, Australia. Healthy adults (aged ≥18 to ≤55 years) who had tested negative for SARS-CoV-2, reported no close contact with anyone with active or previous SARS-CoV-2 infection, and tested negative for pre-existing SARS-CoV-2 immunity were included. Participants were randomly assigned to one of five treatment groups and received two doses via intramuscular injection 28 days apart of either placebo, sclamp vaccine at 5 μg, 15 μg, or 45 μg, or one dose of sclamp vaccine at 45 μg followed by placebo. Participants and study personnel, except the dose administration personnel, were masked to treatment. The primary safety endpoints included solicited local and systemic adverse events in the 7 days after each dose and unsolicited adverse events up to 12 months after dosing. Here, data are reported up until day 57. Primary immunogenicity endpoints were antigen-specific IgG ELISA and SARS-CoV-2 microneutralisation assays assessed at 28 days after each dose. The study is ongoing and registered with ClinicalTrials.gov, NCT04495933.
FINDINGS


Between June 23, 2020, and Aug 17, 2020, of 314 healthy volunteers screened, 120 were randomly assigned (n=24 per group), and 114 (95%) completed the study up to day 57 (mean age 32·5 years [SD 10·4], 65 [54%] male, 55 [46%] female). Severe solicited reactions were infrequent and occurred at similar rates in participants receiving placebo (two [8%] of 24) and the SARS-CoV-2 sclamp vaccine at any dose (three [3%] of 96). Both solicited reactions and unsolicited adverse events occurred at a similar frequency in participants receiving placebo and the SARS-CoV-2 sclamp vaccine. Solicited reactions occurred in 19 (79%) of 24 participants receiving placebo and 86 (90%) of 96 receiving the SARS-CoV-2 sclamp vaccine at any dose. Unsolicited adverse events occurred in seven (29%) of 24 participants receiving placebo and 35 (36%) of 96 participants receiving the SARS-CoV-2 sclamp vaccine at any dose. Vaccination with SARS-CoV-2 sclamp elicited a similar antigen-specific response irrespective of dose: 4 weeks after the initial dose (day 29) with 5 μg dose (geometric mean titre [GMT] 6400, 95% CI 3683-11 122), with 15 μg dose (7492, 4959-11 319), and the two 45 μg dose cohorts (8770, 5526-13 920 in the two-dose 45 μg cohort; 8793, 5570-13 881 in the single-dose 45 μg cohort); 4 weeks after the second dose (day 57) with two 5 μg doses (102 400, 64 857-161 676), with two 15 μg doses (74 725, 51 300-108 847), with two 45 μg doses (79 586, 55 430-114 268), only a single 45 μg dose (4795, 2858-8043). At day 57, 67 (99%) of 68 participants who received two doses of sclamp vaccine at any concentration produced a neutralising immune response, compared with six (25%) of 24 who received a single 45 μg dose and none of 22 who received placebo. Participants receiving two doses of sclamp vaccine elicited similar neutralisation titres, irrespective of dose: two 5 μg doses (GMT 228, 95% CI 146-356), two 15 μg doses (230, 170-312), and two 45 μg doses (239, 187-307).
INTERPRETATION


This first-in-human trial shows that a subunit vaccine comprising mammalian cell culture-derived, MF59-adjuvanted, molecular clamp-stabilised recombinant spike protein elicits strong immune responses with a promising safety profile. However, the glycoprotein 41 peptide present in the clamp created HIV diagnostic assay interference, a possible barrier to widespread use highlighting the criticality of potential non-spike directed immunogenicity during vaccine development. Studies are ongoing with alternative molecular clamp trimerisation domains to ameliorate this response.
FUNDING


Coalition for Epidemic Preparedness Innovations, National Health and Medical Research Council, Queensland Government, and further philanthropic sources listed in the acknowledgments.",2021,Both solicited reactions and unsolicited adverse events occurred at a similar frequency in participants receiving placebo and the SARS-CoV-2 sclamp vaccine.,"['Between June 23, 2020, and Aug 17, 2020, of 314 healthy volunteers screened', '120 were randomly assigned (n=24 per group), and 114 (95%) completed the study up to day 57 (mean age 32·5 years [SD 10·4], 65 [54%] male, 55 [46%] female', 'Healthy adults (aged ≥18 to ≤55 years) who had tested negative for SARS-CoV-2, reported no close contact with anyone with active or previous SARS-CoV-2 infection, and tested negative for pre-existing SARS-CoV-2 immunity were included', 'SARS-CoV-2']","['sclamp subunit vaccine', 'MF59-adjuvanted subunit vaccine', 'GMT', 'placebo', 'sclamp vaccine', 'placebo, sclamp vaccine', 'sclamp vaccine at 45 μg followed by placebo', 'MF59-adjuvanted spike glycoprotein-clamp vaccine']","['unsolicited adverse events', 'Unsolicited adverse events', 'Solicited reactions', 'Safety and immunogenicity', 'neutralisation titres', 'Severe solicited reactions', 'safety and immunogenicity', 'antigen-specific IgG ELISA and SARS-CoV-2 microneutralisation assays', 'solicited local and systemic adverse events in the 7 days after each dose and unsolicited adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0887892', 'cui_str': 'Vaccines, Subunit'}, {'cui': 'C0289787', 'cui_str': 'MF59 oil emulsion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0456981', 'cui_str': 'Specific antigen'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",120.0,0.562498,Both solicited reactions and unsolicited adverse events occurred at a similar frequency in participants receiving placebo and the SARS-CoV-2 sclamp vaccine.,"[{'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Chappell', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, St Lucia, QLD, Australia; The Australian Institute for Biotechnology and Nanotechnology, The University of Queensland, St Lucia, QLD, Australia; Australian Infectious Disease Research Centre, The University of Queensland, St Lucia, QLD, Australia. Electronic address: k.chappell@uq.edu.au.'}, {'ForeName': 'Francesca L', 'Initials': 'FL', 'LastName': 'Mordant', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Zheyi', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Immunology and Infectious Disease, The John Curtin School of Medical Research, The Australian National University, Canberra, ACT, Australia.'}, {'ForeName': 'Danushka K', 'Initials': 'DK', 'LastName': 'Wijesundara', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, St Lucia, QLD, Australia; The Australian Institute for Biotechnology and Nanotechnology, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Lackenby', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, St Lucia, QLD, Australia; The Australian Institute for Biotechnology and Nanotechnology, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Stacey T M', 'Initials': 'STM', 'LastName': 'Cheung', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Naphak', 'Initials': 'N', 'LastName': 'Modhiran', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avumegah', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, St Lucia, QLD, Australia; The Australian Institute for Biotechnology and Nanotechnology, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Henderson', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, St Lucia, QLD, Australia; The Australian Institute for Biotechnology and Nanotechnology, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Kym', 'Initials': 'K', 'LastName': 'Hoger', 'Affiliation': 'The Australian Institute for Biotechnology and Nanotechnology, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Griffin', 'Affiliation': 'School of Medicine, The University of Queensland, St Lucia, QLD, Australia; Nucleus Network Brisbane Clinic, Herston, QLD, Australia; Department of Infectious Diseases, Mater Health, QLD, Australia.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Bennet', 'Affiliation': 'Tanawell Nominees, Melbourne, VIC, Australia.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Hensen', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Wuji', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Thi H O', 'Initials': 'THO', 'LastName': 'Nguyen', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Marrero-Hernandez', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Selva', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Amy W', 'Initials': 'AW', 'LastName': 'Chung', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Mai H', 'Initials': 'MH', 'LastName': 'Tran', 'Affiliation': 'TetraQ, The University of Queensland, Herston, QLD, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tapley', 'Affiliation': 'TetraQ, The University of Queensland, Herston, QLD, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Barnes', 'Affiliation': 'WHO Collaborating Centre for Reference and Research on Influenza, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Reading', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia; WHO Collaborating Centre for Reference and Research on Influenza, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Suellen', 'Initials': 'S', 'LastName': 'Nicholson', 'Affiliation': 'Victorian Infectious Diseases Reference Laboratory, The Royal Melbourne Hospital, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Corby', 'Affiliation': 'Victorian Infectious Diseases Reference Laboratory, The Royal Melbourne Hospital, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Holgate', 'Affiliation': 'Victorian Infectious Diseases Reference Laboratory, The Royal Melbourne Hospital, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Wines', 'Affiliation': 'Immune Therapies Group, Burnet Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'P Mark', 'Initials': 'PM', 'LastName': 'Hogarth', 'Affiliation': 'Immune Therapies Group, Burnet Institute, Melbourne, VIC, Australia; Department of Clinical Pathology, The University of Melbourne, Parkville, VIC, Australia; Department of Immunology and Pathology, Monash University, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kedzierska', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Damian F J', 'Initials': 'DFJ', 'LastName': 'Purcell', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Charani', 'Initials': 'C', 'LastName': 'Ranasinghe', 'Affiliation': 'Department of Immunology and Infectious Disease, The John Curtin School of Medical Research, The Australian National University, Canberra, ACT, Australia.'}, {'ForeName': 'Kanta', 'Initials': 'K', 'LastName': 'Subbarao', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia; WHO Collaborating Centre for Reference and Research on Influenza, The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Watterson', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, St Lucia, QLD, Australia; The Australian Institute for Biotechnology and Nanotechnology, The University of Queensland, St Lucia, QLD, Australia; Australian Infectious Disease Research Centre, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Young', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, St Lucia, QLD, Australia; The Australian Institute for Biotechnology and Nanotechnology, The University of Queensland, St Lucia, QLD, Australia; Australian Infectious Disease Research Centre, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Trent P', 'Initials': 'TP', 'LastName': 'Munro', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, St Lucia, QLD, Australia; The Australian Institute for Biotechnology and Nanotechnology, The University of Queensland, St Lucia, QLD, Australia.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(21)00200-0']
728,33860839,"Age-related hearing loss, depression and auditory amplification: a randomized clinical trial.","PURPOSE


Our study investigates the effectiveness of aural rehabilitation to decrease depressive symptoms in older adults, and the relationship between hearing loss and depression.
METHODS


A randomized controlled study was conducted at a hearing rehabilitation center with people over 65 years old. Participants were randomly allocated to the intervention group who received hearing aids, or to the control group. Data collection included pure-tone audiometry and a Portuguese version of the Geriatric Depression Scale assessed at two time points: baseline (P0) and after 4-week period (P1).
RESULTS


The results show that the increase of hearing thresholds in pure-tone audiometry is associated with a significant increase in depressive symptoms (p = 0.001). The effect of aural rehabilitation for improving depressive symptoms was significant in intervention group (p = 0.000) and between groups (p = 0.003) in P1.
CONCLUSION


Age-related hearing loss has adverse effects on older adults' mental health, due to reduced hearing inputs that may increase levels of effort to communicate and affect social engagement, which lead to depression. Hearing aid use improves levels of depression and can promote greater quality of life in older adults.",2022,"The effect of aural rehabilitation for improving depressive symptoms was significant in intervention group (p = 0.000) and between groups (p = 0.003) in P1.
","['hearing rehabilitation center with people over 65\xa0years old', 'older adults']","['aural rehabilitation', 'hearing aids, or to the control group']","['hearing thresholds', 'quality of life', 'depressive symptoms', 'pure-tone audiometry and a Portuguese version of the Geriatric Depression Scale']","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0034994', 'cui_str': 'Hearing Impaired Rehabilitation'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0234732', 'cui_str': 'Threshold of hearing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0004292', 'cui_str': 'Pure tone audiometry'}, {'cui': 'C0032730', 'cui_str': 'Portuguese'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}]",,0.016826,"The effect of aural rehabilitation for improving depressive symptoms was significant in intervention group (p = 0.000) and between groups (p = 0.003) in P1.
","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Marques', 'Affiliation': 'Department of Biomedicine, Faculty of Medicine, University of Porto, Porto, Portugal. tatiana.marques@estescoimbra.pt.'}, {'ForeName': 'Filipa D', 'Initials': 'FD', 'LastName': 'Marques', 'Affiliation': 'Department of Education, Coimbra College of Education, Coimbra, Portugal.'}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Miguéis', 'Affiliation': 'University Clinic of Otorhinolaryngology, Faculty of Medicine, University of Coimbra, Coimbra, Portugal.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-021-06805-6']
729,33876306,Technical considerations depending on the level of vascular ligation in laparoscopic rectal resection.,"AIM


In addition to ischemia there is also anastomotic ends tension proven to be a risk factor for anastomotic leak. HT vascular ligation is accepted as a rule, in attempt to achieve tension-free anastomosis. LT is a preferred option, based on the more accurate preservation of proximal intestinal segment microperfusion and lower risk of damage to the hypogastric plexus. The aim of this study is evaluation of comparative indicators in high tie (HT) and low tie (LT) laparoscopic rectal resections.
METHODS


A prospective nonrandomized comparative cohort study of patients in our department with cancer of the rectum in clinical stage I-III, operated on in laparoscopic approach over a 6-years period.
RESULTS


For the period 2015-2020, a number of 208 laparoscopic surgeries have been done for rectal cancer. Patients were divided into three groups-group A with HT vascular ligation 116 pts. (69%), group B-53 pts. (25%), underwent low ligation-LT and group C-39pts. (19%) low tie plus lymph node dissection of the apical LN group (LT-appic LND). The distribution was made without randomization, based on the operators' expertise. Anastomotic leaks were 3.8% in group A, 3.0% in group B and 2.9% in group C (p > 0.05) with no significance difference. There is no significant difference in the number of lymph nodes obtained in group A and group B, while in group C the number of the harvested lymph nodes was higher (p < 0.05). The indicators for intestinal / defecation dysfunction, as well as for urinary/sexual dysfunction, according to our data, are significantly more favorable in patients with LT, in contrast to the other two groups.
CONCLUSION


HT vascular ligation attempts to achieve tension-free anastomosis and more harvested lymph nodes. However, LT could be a preferred option, based on the lack of significant evidence for a difference in specific oncological survival and due to more accurate preservation of proximal intestinal segment microperfusion to prevent anastomosis dehiscence, also for its lower risk of damage to the hypogastric plexus. Splenic flexure mobilization provides elongation of the proximal intestinal segment, but has no proven effect on anastomotic leakage incidence. It increases surgical duration and is in fact necessary in up to 30% of the cases. At the present moment there is no precise data whether LT has an advantage in terms of prevention of autonomic nervous and urogenital dysfunction. New prospective randomized and highly probative studies are needed to standardize the procedures in specific clinical situations.",2022,"There is no significant difference in the number of lymph nodes obtained in group A and group B, while in group C the number of the harvested lymph nodes was higher (p < 0.05).","['laparoscopic rectal resection', 'patients in our department with cancer of the rectum in clinical stage I-III, operated on in laparoscopic approach over a 6-years period']","['HT vascular ligation', 'HT vascular ligation 116\xa0pts', 'high tie (HT) and low tie (LT) laparoscopic rectal resections']","['number of the harvested lymph nodes', 'number of lymph nodes', 'Anastomotic leaks', 'specific oncological survival', 'surgical duration']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0193062', 'cui_str': 'Resection of rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205564', 'cui_str': 'Clinical stage I'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0453920', 'cui_str': 'Tie'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0193062', 'cui_str': 'Resection of rectum'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0331669,"There is no significant difference in the number of lymph nodes obtained in group A and group B, while in group C the number of the harvested lymph nodes was higher (p < 0.05).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sokolov', 'Affiliation': 'Department of Surgery, University Hospital Alexandrovska, Sofia, St. Georgi Sofiyski Str. 1, 1431, Sofia, Bulgaria. msokolov@medfac.mu-sofia.bg.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Petrov', 'Affiliation': 'Department of Surgery, University Hospital Alexandrovska, Sofia, St. Georgi Sofiyski Str. 1, 1431, Sofia, Bulgaria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Maslyankov', 'Affiliation': 'Department of Surgery, University Hospital Alexandrovska, Sofia, St. Georgi Sofiyski Str. 1, 1431, Sofia, Bulgaria.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Angelov', 'Affiliation': 'Department of Surgery, University Hospital Alexandrovska, Sofia, St. Georgi Sofiyski Str. 1, 1431, Sofia, Bulgaria.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Atanasova', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University Hospital Alexandrovska, Sofia, Bulgaria.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tzoneva', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University Hospital Alexandrovska, Sofia, Bulgaria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gribnev', 'Affiliation': 'Department of Surgery, University Hospital Alexandrovska, Sofia, St. Georgi Sofiyski Str. 1, 1431, Sofia, Bulgaria.'}]",Surgical endoscopy,['10.1007/s00464-021-08479-x']
730,33873154,"Autonomic and Perceptual Responses to Induction of a Ketogenic Diet in Free-Living Endurance Athletes: A Randomized, Crossover Trial.","PURPOSE


Considerable interindividual heterogeneity has been observed in endurance performance responses following induction of a ketogenic diet (KD). It is plausible that a physiological stress response in the period following the dramatic dietary shift associated with transition to a KD may explain this heterogeneity.
METHODS


In a randomized, crossover study design, 8 trained male runners completed an incremental exercise test and ran to exhaustion at 70%VO2max before and after a 31-day rigorously controlled habitual diet or KD intervention, and recorded heart rate variability (root mean square of the sum of successive differences in R-R intervals [rMSSD]) upon waking each morning along with the recovery-stress questionnaire for athletes each week. Data were analyzed using linear mixed models.
RESULTS


A significant reduction in rMSSD was observed in the KD (-9.77 [4.03] ms, P = .02), along with an increase in day-to-day variability in rMSSD (2.1% [1.0%], P = .03). The reduction in rMSSD in the KD for the subgroup of individuals exhibiting impaired exercise capacity following induction of the KD approached significance (Δ -22 [15] ms, P = .06, N = 4); whereas no effect was observed in those who exhibited unchanged exercise capacity (Δ 5 [18] ms, P = .61, N = 4). No main effects were observed for recovery-stress questionnaire for athletes.
CONCLUSIONS


Our data suggest those working with endurance athletes transitioning onto a KD may consider using noninvasive, inexpensive resting heart rate variability measures to gain individual-level insights into the likely short-term effects on exercise capacity.",2021,"No main effects were observed for recovery-stress questionnaire for athletes.
","['8 trained male runners completed an', 'Free-Living Endurance Athletes']","['ketogenic diet (KD', 'Ketogenic Diet', 'incremental exercise test and ran to exhaustion at 70%VO2max before and after a 31-day rigorously controlled habitual diet or KD intervention']","['recovery-stress questionnaire', 'rMSSD', 'exercise capacity', 'reduction in rMSSD']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",8.0,0.05087,"No main effects were observed for recovery-stress questionnaire for athletes.
","[{'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Maunder', 'Affiliation': ''}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Dulson', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Shaw', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0814']
731,33880701,Can a Dyadic Resiliency Program Improve Quality of Life in Cognitively Intact Dyads of Neuro-ICU Survivors and Informal Caregivers? Results from a Pilot RCT.,"BACKGROUND


Neuro-ICU hospitalization for an acute neurological illness is often traumatic and associated with heightened emotional distress and reduced quality of life (QoL) for both survivors and their informal caregivers (i.e., family and friends providing unpaid care). In a pilot study, we previously showed that a dyadic (survivor and caregiver together) resiliency intervention (Recovering Together [RT]) was feasible and associated with sustained improvement in emotional distress when compared with an attention placebo educational control. Here we report on changes in secondary outcomes assessing QoL.
METHODS


Survivors (n = 58) and informal caregivers (n = 58) completed assessments at bedside and were randomly assigned to participate together as a dyad in the RT or control intervention (both 6 weeks, two in-person sessions at bedside and four sessions via live video post discharge). We measured QoL domain scores (physical health, psychological, social relations, and environmental), general QoL, and QoL satisfaction using the World Health Organization Quality of Life Abbreviated Instrument at baseline, post treatment, and 3 months' follow-up. We conducted mixed model analyses of variance with linear contrasts to estimate (1) within-group changes in QoL from baseline to post treatment and from post treatment to 3 months' follow-up and (2) between-group differences in changes in QoL from baseline to post treatment and from post treatment to 3 months' follow-up.
RESULTS


We found significant within-group improvements from baseline to post treatment among RT survivors for physical health QoL (mean difference 1.73; 95% confidence interval [CI] 0.39-3.06; p = 0.012), environmental QoL (mean difference 1.29; 95% CI 0.21-2.36; p = 0.020), general QoL (mean difference 0.55; 95% CI 0.13-0.973; p = 0.011), and QoL satisfaction (mean difference 0.87; 95% CI 0.36-1.37; p = 0.001), and those improvements sustained through the 3-month follow-up. We found no significant between-group improvements for survivors or caregivers from baseline to post treatment or from post treatment to 3 months' follow-up for any QoL variables (i.e., domains, general QoL, and QoL satisfaction together).
CONCLUSIONS


In this pilot study, we found improved QoL among survivors, but not in caregivers, who received RT and improvements sustained over time. These RT-related improvements were not significantly greater than those observed in the control. Results support a fully powered randomized controlled trial to allow for a definitive evaluation of RT-related effects among dyads of survivors of acute brain injury and their caregivers.",2021,"We found no significant between-group improvements for survivors or caregivers from baseline to post treatment or from post treatment to 3 months' follow-up for any QoL variables (i.e., domains, general QoL, and QoL satisfaction together).
","['Survivors (n\u2009=\u200958) and informal caregivers (n\u2009=\u200958) completed assessments at bedside', 'Cognitively Intact Dyads of Neuro-ICU Survivors and Informal Caregivers']","['dyadic (survivor and caregiver together) resiliency intervention (Recovering Together [RT', 'RT or control intervention', 'Dyadic Resiliency Program']","['QoL satisfaction', 'QoL domain scores (physical health, psychological, social relations, and environmental), general QoL, and QoL satisfaction using the World Health Organization Quality of Life Abbreviated Instrument', 'physical health QoL', 'environmental QoL', 'Quality of Life', 'emotional distress', 'quality of life (QoL', 'general QoL']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",,0.104768,"We found no significant between-group improvements for survivors or caregivers from baseline to post treatment or from post treatment to 3 months' follow-up for any QoL variables (i.e., domains, general QoL, and QoL satisfaction together).
","[{'ForeName': 'Ethan G', 'Initials': 'EG', 'LastName': 'Lester', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Mace', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, USA.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Bannon', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, USA.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Popok', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, USA.'}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Gates', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Meyers', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Tehan', 'Affiliation': 'Neuroscience Intensive Care Unit, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Sagueiro', 'Affiliation': 'Neuroscience Intensive Care Unit, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosand', 'Affiliation': 'Harvard Medical School, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Harvard Medical School, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, USA. avranceanu@mgh.harvard.edu.'}]",Neurocritical care,['10.1007/s12028-021-01222-3']
732,33875799,"Omega-3 supplementation and stress reactivity of cellular aging biomarkers: an ancillary substudy of a randomized, controlled trial in midlife adults.","Higher levels of omega-3 track with longer telomeres, lower inflammation, and blunted sympathetic and cardiovascular stress reactivity. Whether omega-3 supplementation alters the stress responsivity of telomerase, cortisol, and inflammation is unknown. This randomized, controlled trial examined the impact of omega-3 supplementation on cellular aging-related biomarkers following a laboratory speech stressor. In total, 138 sedentary, overweight, middle-aged participants (n = 93 women, n = 45 men) received either 2.5 g/d of omega-3, 1.25 g/d of omega-3, or a placebo for 4 months. Before and after the trial, participants underwent the Trier Social Stress Test. Saliva and blood samples were collected once before and repeatedly after the stressor to measure salivary cortisol, telomerase in peripheral blood lymphocytes, and serum anti-inflammatory (interleukin-10; IL-10) and pro-inflammatory (interleukin-6; IL-6, interleukin-12, tumor necrosis factor-alpha) cytokines. Adjusting for pre-supplementation reactivity, age, sagittal abdominal diameter, and sex, omega-3 supplementation altered telomerase (p = 0.05) and IL-10 (p = 0.05) stress reactivity; both supplementation groups were protected from the placebo group's 24% and 26% post-stress declines in the geometric means of telomerase and IL-10, respectively. Omega-3 also reduced overall cortisol (p = 0.03) and IL-6 (p = 0.03) throughout the stressor; the 2.5 g/d group had 19% and 33% lower overall cortisol levels and IL-6 geometric mean levels, respectively, compared to the placebo group. By lowering overall inflammation and cortisol levels during stress and boosting repair mechanisms during recovery, omega-3 may slow accelerated aging and reduce depression risk. ClinicalTrials.gov identifier: NCT00385723.",2021,"Omega-3 also reduced overall cortisol (p = 0.03) and IL-6 (p = 0.03) throughout the stressor; the 2.5 g/d group had 19% and 33% lower overall cortisol levels and IL-6 geometric mean levels, respectively, compared to the placebo group.","['138 sedentary, overweight, middle-aged participants (n\u2009=\u200993 women, n\u2009=\u200945 men', 'midlife adults']","['omega-3 supplementation', 'Omega-3 supplementation', '2.5\u2009g/d of omega-3, 1.25\u2009g/d of omega-3, or a placebo', 'placebo']","['stress reactivity of cellular aging biomarkers', 'IL-6', 'Saliva and blood samples', 'stress responsivity of telomerase, cortisol, and inflammation', 'overall cortisol levels and IL-6 geometric mean levels', 'salivary cortisol, telomerase in peripheral blood lymphocytes, and serum anti-inflammatory (interleukin-10; IL-10) and pro-inflammatory (interleukin-6; IL-6, interleukin-12, tumor necrosis factor-alpha) cytokines', 'overall cortisol', 'lower inflammation, and blunted sympathetic and cardiovascular stress reactivity']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0087071', 'cui_str': 'Telomerase Reverse Transcriptase'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",138.0,0.71963,"Omega-3 also reduced overall cortisol (p = 0.03) and IL-6 (p = 0.03) throughout the stressor; the 2.5 g/d group had 19% and 33% lower overall cortisol levels and IL-6 geometric mean levels, respectively, compared to the placebo group.","[{'ForeName': 'Annelise A', 'Initials': 'AA', 'LastName': 'Madison', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Belury', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Andridge', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Renna', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rosie Shrout', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Malarkey', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Biochemistry and Biophysics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Janice K', 'Initials': 'JK', 'LastName': 'Kiecolt-Glaser', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA. Janice.Kiecolt-Glaser@osumc.edu.'}]",Molecular psychiatry,['10.1038/s41380-021-01077-2']
733,33884414,Effects of Behavioral Weight Loss and Metformin on IGFs in Cancer Survivors: A Randomized Trial.,"CONTEXT


Higher levels of insulin-like growth factor-1 (IGF-1) are associated with increased risk of cancers and higher mortality. Therapies that reduce IGF-1 have considerable appeal as means to prevent recurrence.
DESIGN


Randomized, 3-parallel-arm controlled clinical trial.
INTERVENTIONS AND OUTCOMES


Cancer survivors with overweight or obesity were randomized to (1) self-directed weight loss (comparison), (2) coach-directed weight loss, or (3) metformin treatment. Main outcomes were changes in IGF-1 and IGF-1:IGFBP3 molar ratio at 6 months. The trial duration was 12 months.
RESULTS


Of the 121 randomized participants, 79% were women, 46% were African Americans, and the mean age was 60 years. At baseline, the average body mass index was 35 kg/m2; mean IGF-1 was 72.9 (SD, 21.7) ng/mL; and mean IGF1:IGFBP3 molar ratio was 0.17 (SD, 0.05). At 6 months, weight changes were -1.0% (P = 0.07), -4.2% (P < 0.0001), and -2.8% (P < 0.0001) in self-directed, coach-directed, and metformin groups, respectively. Compared with the self-directed group, participants in metformin had significant decreases on IGF-1 (mean difference in change: -5.50 ng/mL, P = 0.02) and IGF1:IGFBP3 molar ratio (mean difference in change: -0.0119, P = 0.011) at 3 months. The significant decrease of IGF-1 remained in participants with obesity at 6 months (mean difference in change: -7.2 ng/mL; 95% CI: -13.3 to -1.1), but not in participants with overweight (P for interaction = 0.045). There were no significant differences in changes between the coach-directed and self-directed groups. There were no differences in outcomes at 12 months.
CONCLUSIONS


In cancer survivors with obesity, metformin may have a short-term effect on IGF-1 reduction that wanes over time.",2021,"Compared to the self-directed group, participants in metformin had significant decreases on IGF-1 (mean difference in change: -5.50 ng/ml, p=0.02) and IGF1:IGFBP3 molar ratio (mean difference in change: -0.0119, p=0.011) at 3 months.","['Of the 121 randomized participants, 79% were women, 46% were African Americans, and the mean age was 60 years', 'Cancer Survivors', 'Cancer survivors with overweight or obesity']","['metformin', 'Behavioral Weight Loss and Metformin', 'self-directed weight loss (comparison), 2) coach-directed weight loss, or 3) metformin treatment']","['IGF-1 and IGF-1:IGFBP3 molar ratio', 'mean IGF1:IGFBP3 molar ratio', 'weight changes', 'average BMI', 'risk of cancers and higher mortality', 'IGF-1', 'insulin-like growth factor-1 (IGF-1', 'IGF1:IGFBP3 molar ratio', 'mean IGF-1']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",121.0,0.479751,"Compared to the self-directed group, participants in metformin had significant decreases on IGF-1 (mean difference in change: -5.50 ng/ml, p=0.02) and IGF1:IGFBP3 molar ratio (mean difference in change: -0.0119, p=0.011) at 3 months.","[{'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Nisa M', 'Initials': 'NM', 'LastName': 'Maruthur', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Jerome', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Arlene T', 'Initials': 'AT', 'LastName': 'Dalcin', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'White', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Mueller', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Charleston', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Nowella', 'Initials': 'N', 'LastName': 'Durkin', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hassoon', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Dina G', 'Initials': 'DG', 'LastName': 'Lansey', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Norma F', 'Initials': 'NF', 'LastName': 'Kanarek', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab266']
734,33886115,Combination of Dydrogesterone and Antibiotic Versus Antibiotic Alone for Chronic Endometritis: a Randomized Controlled Trial Study.,"To evaluate the impact of dydrogesterone in the treatment of chronic endometritis with antibiotic treatment in premenopausal women. A total of 188 chronic endometritis patients diagnosed by syndecan-1 (CD138) expression were enrolled in this randomized controlled trial study. Dydrogesterone and doxycycline were given in the treatment group, while single antibiotic was given in the control group. CD138, estrogen receptor, and progesterone receptor expression in samples of the endometrium was analyzed by immunohistochemistry. Comparison of chronic endometritis cure rate between groups was performed based on conversion of CD138 expression from positive to negative. The 188 cases included in the statistical analysis consisted of 93 cases in the treatment group and 95 cases in the control group. The cure rates of chronic endometritis in the dydrogesterone and antibiotic combination group and the single antibiotic group were 86.0% (80/93) and 72.6% (69/95), respectively, with an overall cure rate of 79.3% (149/188). The dydrogesterone and antibiotic combination group showed better effects regarding the cure rate of chronic endometritis (P<.05). Multivariate analysis showed that the cure rate of chronic endometritis was not affected by age, clinical diagnosis, hysteroscopic resection, estrogen receptor status, or progesterone receptor status (all P>.05). Addition of dydrogesterone was effective for the treatment of chronic endometritis with antibiotic treatment in premenopausal women. The study was retrospectively registered to Chinese Clinical Trial Registry (ChiCTR2000040227) in November 2020.",2021,"Multivariate analysis showed that the cure rate of chronic endometritis was not affected by age, clinical diagnosis, hysteroscopic resection, estrogen receptor status, or progesterone receptor status (all P>.05).","['chronic endometritis with antibiotic treatment in premenopausal women', 'Chronic Endometritis', '188 chronic endometritis patients diagnosed by syndecan-1']","['Dydrogesterone and Antibiotic Versus Antibiotic Alone', 'Dydrogesterone and doxycycline', 'dydrogesterone', 'dydrogesterone and antibiotic combination']","['chronic endometritis cure rate', 'clinical diagnosis, hysteroscopic resection, estrogen receptor status, or progesterone receptor status', 'CD138, estrogen receptor, and progesterone receptor expression', 'cure rate of chronic endometritis', 'overall cure rate', 'cure rates of chronic endometritis']","[{'cui': 'C0238104', 'cui_str': 'Chronic endometritis'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}]","[{'cui': 'C0013340', 'cui_str': 'Dydrogesterone'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}]","[{'cui': 'C0238104', 'cui_str': 'Chronic endometritis'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034833', 'cui_str': 'Progesterone receptor'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",188.0,0.149312,"Multivariate analysis showed that the cure rate of chronic endometritis was not affected by age, clinical diagnosis, hysteroscopic resection, estrogen receptor status, or progesterone receptor status (all P>.05).","[{'ForeName': 'Dacheng', 'Initials': 'D', 'LastName': 'Qu', 'Affiliation': 'Department of Obstetrics and Gynecology, Affiliated Hospital of North Sichuan Medical College, No 63, Wenhua Road, Nanchong, Sichuan province, China.'}, {'ForeName': 'Maomei', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ""Department of Obstetrics and Gynecology, Chengdu Second People's Hospital, Chengdu, China.""}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Tong', 'Affiliation': ""Department of Obstetrics and Gynecology, Nanbu County People's Hospital, Nanbu, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Obstetrics and Gynecology, Affiliated Hospital of North Sichuan Medical College, No 63, Wenhua Road, Nanchong, Sichuan province, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Jing', 'Affiliation': 'Department of Obstetrics and Gynecology, Affiliated Hospital of North Sichuan Medical College, No 63, Wenhua Road, Nanchong, Sichuan province, China.'}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Obstetrics and Gynecology, Affiliated Hospital of North Sichuan Medical College, No 63, Wenhua Road, Nanchong, Sichuan province, China.'}, {'ForeName': 'Honggui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Obstetrics and Gynecology, Affiliated Hospital of North Sichuan Medical College, No 63, Wenhua Road, Nanchong, Sichuan province, China. 5252624@qq.com.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-021-00583-6']
735,33866968,Effectiveness of Wellbeing Intervention for Chronic Kidney Disease (WICKD): results of a randomised controlled trial.,"BACKGROUND


End stage kidney disease (ESKD) is associated with many losses, subsequently impacting mental wellbeing. Few studies have investigated the efficacy of psychosocial interventions for people with ESKD and none exist for Indigenous people, a population in which the ESKD burden is especially high.
METHODS


This three-arm, waitlist, single-blind randomised controlled trial examined efficacy of the Stay Strong App in improving psychological distress (Kessler distress scale; K10), depressive symptoms (adapted Patient Health Questionnaire; PHQ-9), quality of life (EuroQoL; EQ. 5D) and dialysis adherence among Indigenous Australians undergoing haemodialysis in central and northern Australia (Alice Springs and Darwin), with follow up over two 3-month periods. Effects of immediate AIMhi Stay Strong App treatment were compared with those from a contact control app (The Hep B Story) and treatment as usual (TAU). Control conditions received the Stay Strong intervention after 3 months.
RESULTS


Primary analyses of the full sample (N = 156) showed statistically significant decreases in K10 and PHQ-9 scores at 3 months for the Hep B Story but not for the Stay Strong app or TAU. Restricting the sample to those with moderate to severe symptoms of distress or depression (K10 > =25 or PHQ-9 > =10) showed significant decreases in K10 and PHQ-9 scores for both Stay Strong and Hep B Story. No significant differences were observed for the EQ-5D or dialysis attendance.
CONCLUSIONS


Findings suggest that talking to people about their wellbeing and providing information relevant to kidney health using culturally adapted, locally relevant apps improve the wellbeing of people on dialysis. Further research is required to replicate these findings and identify active intervention components.
TRIAL REGISTRATION


ACTRN12617000249358 ; 17/02/2017.",2021,"No significant differences were observed for the EQ-5D or dialysis attendance.
","['Indigenous Australians undergoing haemodialysis in central and northern Australia (Alice Springs and Darwin', 'Chronic Kidney Disease (WICKD']","['Stay Strong App', 'Stay Strong intervention', 'immediate AIMhi Stay Strong App treatment', 'Wellbeing Intervention']","['psychological distress (Kessler distress scale; K10), depressive symptoms (adapted Patient Health Questionnaire; PHQ-9), quality of life (EuroQoL; EQ', '5D) and dialysis adherence', 'EQ-5D or dialysis attendance', 'severe symptoms of distress or depression', 'K10 and PHQ-9 scores']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0442985', 'cui_str': 'Alice'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0818341,"No significant differences were observed for the EQ-5D or dialysis attendance.
","[{'ForeName': 'Kylie M', 'Initials': 'KM', 'LastName': 'Dingwall', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Alice Springs, NT, 0870, Australia. kylie.dingwall@menzies.edu.au.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Sweet', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Alice Springs, NT, 0870, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cass', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Darwin, NT, 0811, Australia.'}, {'ForeName': 'Jaquelyne T', 'Initials': 'JT', 'LastName': 'Hughes', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Darwin, NT, 0811, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kavanagh', 'Affiliation': ""Centre for Children's Health Research and School of Psychology & Counselling, Faculty of Health, Queensland University of Technology (QUT), Brisbane, QLD, 4101, Australia.""}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Barzi', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Darwin, NT, 0811, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Western Desert Nganampa Walytija Palyantjaku Tjutaku, Alice Springs, NT, 0870, Australia.'}, {'ForeName': 'Cherian', 'Initials': 'C', 'LastName': 'Sajiv', 'Affiliation': 'Central Australian Renal Services, Alice Springs Hospital, Northern Territory Department of Health, Alice Springs, NT, 0870, Australia.'}, {'ForeName': 'Sandawana W', 'Initials': 'SW', 'LastName': 'Majoni', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Darwin, NT, 0811, Australia.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Nagel', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Darwin, NT, 0811, Australia.'}]",BMC nephrology,['10.1186/s12882-021-02344-8']
736,33861548,Association Between Incident Delirium Treatment With Haloperidol and Mortality in Critically Ill Adults.,"OBJECTIVES


Haloperidol is commonly administered in the ICU to reduce the burden of delirium and its related symptoms despite no clear evidence showing haloperidol helps to resolve delirium or improve survival. We evaluated the association between haloperidol, when used to treat incident ICU delirium and its symptoms, and mortality.
DESIGN


Post hoc cohort analysis of a randomized, double-blind, placebo-controlled, delirium prevention trial.
SETTING


Fourteen Dutch ICUs between July 2013 and December 2016.
PATIENTS


One-thousand four-hundred ninety-five critically ill adults free from delirium at ICU admission having an expected ICU stay greater than or equal to 2 days.
INTERVENTIONS


Patients received preventive haloperidol or placebo for up to 28 days until delirium occurrence, death, or ICU discharge. If delirium occurred, treatment with open-label IV haloperidol 2 mg tid (up to 5 mg tid per delirium symptoms) was administered at clinician discretion.
MEASUREMENTS AND MAIN RESULTS


Patients were evaluated tid for delirium and coma for 28 days. Time-varying Cox hazards models were constructed for 28-day and 90-day mortality, controlling for study-arm, delirium and coma days, age, Acute Physiology and Chronic Health Evaluation-II score, sepsis, mechanical ventilation, and ICU length of stay. Among the 1,495 patients, 542 (36%) developed delirium within 28 days (median [interquartile range] with delirium 4 d [2-7 d]). A total of 477 of 542 (88%) received treatment haloperidol (2.1 mg [1.0-3.8 mg] daily) for 6 days (3-11 d). Each milligram of treatment haloperidol administered daily was associated with decreased mortality at 28 days (hazard ratio, 0.93; 95% CI, 0.91-0.95) and 90 days (hazard ratio, 0.97; 95% CI, 0.96-0.98). Treatment haloperidol administered later in the ICU course was less protective of death. Results were stable by prevention study-arm, predelirium haloperidol exposure, and haloperidol treatment protocol adherence.
CONCLUSIONS


Treatment of incident delirium and its symptoms with haloperidol may be associated with a dose-dependent improvement in survival. Future randomized trials need to confirm these results.",2021,"Each milligram of treatment haloperidol administered daily was associated with decreased mortality at 28 days (hazard ratio, 0.93; 95% CI, 0.91-0.95) and 90 days (hazard ratio, 0.97; 95% CI, 0.96-0.98).","['One-thousand four-hundred ninety-five critically ill adults free from delirium at ICU admission having an expected ICU stay greater than or equal to 2 days', 'Fourteen Dutch ICUs between July 2013 and December 2016', 'Critically Ill Adults']","['haloperidol', 'preventive haloperidol or placebo', 'placebo', 'Haloperidol', 'open-label IV haloperidol']","['28-day and 90-day mortality, controlling for study-arm, delirium and coma days, age, Acute Physiology and Chronic Health Evaluation-II score, sepsis, mechanical ventilation, and ICU length of stay', 'protective of death', 'mortality', 'survival', 'delirium']","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4758051', 'cui_str': 'APACHE II (Acute Physiology and Chronic Health Evaluation II) score'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",1495.0,0.173313,"Each milligram of treatment haloperidol administered daily was associated with decreased mortality at 28 days (hazard ratio, 0.93; 95% CI, 0.91-0.95) and 90 days (hazard ratio, 0.97; 95% CI, 0.96-0.98).","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Duprey', 'Affiliation': 'Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston, MA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Devlin', 'Affiliation': 'Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston, MA.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboud Institute for Health Science, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'Department of Intensive Care, Radboud Institute for Health Science, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Becky A', 'Initials': 'BA', 'LastName': 'Briesacher', 'Affiliation': 'Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston, MA.'}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Saczynski', 'Affiliation': 'Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, Boston, MA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Griffith', 'Affiliation': 'Department of Health Sciences, Bouve College of Health Sciences, Northeastern University, Boston, MA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van den Boogaard', 'Affiliation': 'Department of Intensive Care, Radboud Institute for Health Science, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Critical care medicine,['10.1097/CCM.0000000000004976']
737,33878154,Long-term tolerability and efficacy of golimumab in active non-radiographic axial spondyloarthritis: results from open-label extension.,"OBJECTIVES


We report the open-label extension (OLE) of the GO-AHEAD study evaluating the long-term efficacy and safety of golimumab (GLM) in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
METHODS


Patients [both GLM- and placebo (PBO)-treated in the double-blind phase] received GLM 50 mg every 4 weeks during the OLE (36-week treatment; additional 8-week safety follow-up; GLM/GLM and PBO/GLM groups). All patients who entered and received ≥1 dose of study treatment in the OLE were included in the efficacy and safety analyses. The primary efficacy evaluations were the proportions of patients achieving 20% and 40% improvement in the ASAS criteria (ASAS20 and ASAS40, respectively). Responders' analyses were calculated using a non-responder imputation approach.
RESULTS


Of 198 patients randomised, 189/198 (95.5%) entered the OLE; 174/198 patients (87.9%) completed all visits. Although the proportion of responders increased from week 16 to week 52 in the OLE in both GLM/GLM and PBO/GLM groups, the GLM/GLM group had a higher proportion of responders than the PBO/GLM group throughout the OLE from week 16 to week 52 (ASAS20: 71.1% to 83.9% vs 40.0% to 75.0%, respectively; ASAS40: 56.7% to 76.3% vs 23.0% to 59.4%, respectively; ASAS partial remission: 33.0% to 53.8% and 18.0% to 45.8%). In the OLE, the overall incidence of AEs was lower in the GLM/GLM vs PBO/GLM groups (41.9% and 54.2%).
CONCLUSIONS


Sustained improvement in clinical efficacy was observed at 52 weeks in patients with nr-axSpA following GLM treatment. GLM was well tolerated and provided substantial long-term benefits to patients with nr-axSpA.
TRIAL REGISTRATION


NCT01453725; United States National Library of Medicine clinical trials database; www.clinicaltrials.gov.",2022,"CONCLUSIONS


Sustained improvement in clinical efficacy was observed at 52 weeks in patients with nr-axSpA following GLM treatment.","['Of 198 patients randomised, 189/198 (95.5%) entered the OLE; 174/198 patients (87.9%) completed all visits', 'patients with non-radiographic axial spondyloarthritis (nr-axSpA', 'Patients (both']","['OLE', 'GLM- and placebo', 'ASAS20', 'Golimumab', 'GLM', 'ASAS40', 'golimumab (GLM']","['overall incidence of AEs', 'ASAS partial remission', 'clinical efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3889038', 'cui_str': 'Non-radiographic axial spondyloarthritis'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",,0.10114,"CONCLUSIONS


Sustained improvement in clinical efficacy was observed at 52 weeks in patients with nr-axSpA following GLM treatment.","[{'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Rheumatology Department - Hôpital Cochin, Université de Paris, Assistance Publique - Hôpitaux de Paris, INSERM (U1153): Clinical epidemiology and biostatistics, PRES Sorbonne Paris-Cité. Paris, France.'}, {'ForeName': 'Walter P', 'Initials': 'WP', 'LastName': 'Maksymowych', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Bergman', 'Affiliation': 'Merck Research Laboratories, Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Curtis', 'Affiliation': 'Merck Research Laboratories, Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Anjela', 'Initials': 'A', 'LastName': 'Tzontcheva', 'Affiliation': 'Merck Research Laboratories, Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': 'Merck Research Laboratories, Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Philip', 'Affiliation': 'Merck Research Laboratories, Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Sieper', 'Affiliation': 'Department of Gastroenterology, Infectiology and Rheumatology, University Clinic Benjamin Franklin, Berlin, Germany.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keab346']
738,33884645,Early enteral feeding is beneficial for patients after pelvic exenteration surgery: A randomized controlled trial.,"BACKGROUND


Postoperative feeding practices vary after pelvic exenteration surgery because of the lack of nutrition research in this specific surgical area. Postoperative ileus (POI) is common after pelvic exenteration surgery, and early enteral feeding is often avoided because of the lack of evidence and the belief that this may induce POI in this patient cohort. The aim of this study was to determine the effects of early enteral feeding after pelvic exenteration surgery on return of bowel movement and POI.
METHODS


A randomized controlled trial was conducted with patients undergoing pelvic exenteration surgery from November 2018 to June 2020. Forty participants received standard nutrition care (parenteral nutrition) and 47 participants received trophic enteral feeding (20 ml/h) via a nasogastric tube, in addition to standard care, until participants were upgraded to free fluids. Time to first bowel movement and rates of POI were the main outcome measures.
RESULTS


There was no significant difference between arms for time to first bowel movement; however, POI rates were significantly less in participants who were enterally fed (P = .036) in the per-protocol analysis. Regressions showed that the longer patients were restricted from an oral diet after surgery, the greater the time was to first bowel movement and the greater the postoperative complication rates (P < .0005).
CONCLUSIONS


Early enteral feeding can be commenced safely to improve gastrointestinal function after pelvic exenteration surgery.",2022,"There was no significant difference between arms for time to first bowel movement, however postoperative ileus rates were significantly less in participants who were enterally fed (p = 0.036) in the per-protocol analysis.","['patients after pelvic exenteration surgery ', 'patients undergoing pelvic exenteration surgery from November 2018 to June 2020', 'Forty participants received']","['standard nutrition care (total parenteral nutrition', 'early enteral feeding after pelvic exenteration surgery', 'trophic enteral feeding (20mL/hr) via a nasogastric tube in addition to standard care until participants were upgraded to free fluids']","['time to first bowel movement, however postoperative ileus rates', 'Time to first bowel movement and rates of postoperative ileus', 'postoperative complication rates', 'return of bowel movement and postoperative ileus', 'gastrointestinal function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030788', 'cui_str': 'Pelvic exenteration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1258068', 'cui_str': 'Nutrition management'}, {'cui': 'C0030548', 'cui_str': 'Total parenteral nutrition'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0030788', 'cui_str': 'Pelvic exenteration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.108111,"There was no significant difference between arms for time to first bowel movement, however postoperative ileus rates were significantly less in participants who were enterally fed (p = 0.036) in the per-protocol analysis.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hogan', 'Affiliation': 'Department of Nutrition and Dietetics, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Reece', 'Affiliation': 'Department of Nutrition and Dietetics, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Solomon', 'Affiliation': 'Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rangan', 'Affiliation': 'School of Life and Environmental Sciences, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Carey', 'Affiliation': 'Department of Nutrition and Dietetics, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.2120']
739,33905530,"Risk of cardiovascular mortality with androgen deprivation therapy in prostate cancer: A secondary analysis of the Prostate, Lung, Colorectal, and Ovarian (PLCO) Randomized Controlled Trial.","BACKGROUND


For men with radiation-managed prostate cancer, there is conflicting evidence regarding the association between androgen deprivation therapy (ADT) and cardiovascular mortality (CVM), particularly among those who have with preexisting comorbidities. The objective of this study was to analyze the association between ADT and CVM across patient comorbidity status using prospectively collected data from a large clinical trial.
METHODS


In total, 1463 men were identified who were diagnosed with clinically localized, intermediate-risk/high-risk prostate cancer (T2b-T4, Gleason 7-10, or prostate-specific antigen >10 ng/mL) from 1993 to 2001 and managed with either radiation therapy (RT) alone or RT plus ADT during the randomized Prostate, Lung, Colon, and Ovarian (PLCO) Cancer Screening Trial. Adjusted hazard ratios (aHRs) for cause-specific mortality (prostate cancer-specific mortality vs other-cause mortality-including the primary end point of CVM [death from ischemic heart disease, cerebrovascular accident, or other circulatory disease]) were determined using Fine and Gray competing-risk regression analysis and stratified by comorbidity history.
RESULTS


There was no difference in the risk of 5-year CVM between ADT plus RT and RT alone (2.3% vs 3.3%, respectively; aHR, 0.69; 95% CI, 0.38-1.24; P = .21) overall or on subgroup analysis among men with a history of ≥1 preexisting comorbidities (3.2% vs 5.3%, respectively; aHR, 0.83; 95% CI, 0.43-1.60; P = .58), ≥2 preexisting comorbidities (6.9% vs 8.3%, respectively; aHR, 0.95; 95% CI, 0.40-2.25; P = .90), or cardiovascular disease/risk factors (3.6% vs 4.3%, respectively; aHR, 0.85; 95% CI, 0.44-1.65; P = .63). These results were all similar when each component of CVM was analyzed separately-either cardiac, stroke, or other vascular mortality (P > .05).
CONCLUSIONS


This study provides prospectively collected evidence that the use of ADT plus RT, compared with RT alone, is not associated with an increased risk of CVM, even among subgroups of men who have preexisting comorbidities and cardiovascular disease.",2021,"Adjusted hazard ratios (aHRs) for cause-specific mortality (prostate cancer-specific mortality vs other-cause mortality-including the primary end point of CVM [death from ischemic heart disease, cerebrovascular accident, or other circulatory disease]) were determined using Fine and Gray competing-risk regression analysis and stratified by comorbidity history.
","['prostate cancer', 'men with radiation-managed prostate cancer', '1463 men were identified who were diagnosed with clinically localized, intermediate-risk/high-risk prostate cancer (T2b-T4, Gleason 7-10, or prostate-specific antigen >10 ng/mL) from 1993 to 2001 and managed with either radiation therapy (RT) alone or RT plus ADT during the randomized Prostate, Lung, Colon, and Ovarian (PLCO) Cancer Screening Trial', 'subgroups of men who have preexisting comorbidities and cardiovascular disease']","['androgen deprivation therapy', 'ADT plus RT']","['cardiovascular disease/risk factors', 'vascular mortality', 'Adjusted hazard ratios (aHRs) for cause-specific mortality (prostate cancer-specific mortality', 'Prostate, Lung, Colorectal, and Ovarian (PLCO', '≥2 preexisting comorbidities', 'risk of 5-year CVM', 'androgen deprivation therapy (ADT) and cardiovascular mortality (CVM']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0475388', 'cui_str': 'Tumor stage T2b'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]",1463.0,0.482796,"Adjusted hazard ratios (aHRs) for cause-specific mortality (prostate cancer-specific mortality vs other-cause mortality-including the primary end point of CVM [death from ischemic heart disease, cerebrovascular accident, or other circulatory disease]) were determined using Fine and Gray competing-risk regression analysis and stratified by comorbidity history.
","[{'ForeName': 'Santino S', 'Initials': 'SS', 'LastName': 'Butler', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Mahal', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Javid J', 'Initials': 'JJ', 'LastName': 'Moslehi', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Nohria', 'Affiliation': ""Department of Cardiovascular Medicine, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Dee', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Makkar', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Whitbeck', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wangoe', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kent W', 'Initials': 'KW', 'LastName': 'Mouw', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Nguyen', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Vinayak', 'Initials': 'V', 'LastName': 'Muralidhar', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts.""}]",Cancer,['10.1002/cncr.33486']
740,33907293,Diagnostic yield of fusion magnetic resonance-guided prostate biopsy versus cognitive-guided biopsy in biopsy-naive patients: a head-to-head randomized controlled trial.,"BACKGROUND


The combination of MRI-guided targeted biopsy (MRGB) with systematic biopsy (SB) provides the highest accuracy in detecting prostate cancer. There is a controversy over the superiority of fusion targeted biopsy (fus-MRGB) over cognitive targeted biopsy (cog-MRGB). The present head-to-head randomized controlled trial was performed to compare diagnostic yield of fus-MRGB in combination with SB with cog-MRGB in combination with SB.
METHODS


Biopsy-naive patients with a prostate-specific antigen level between 2 and 10 ng/dL who were candidates for prostate biopsy were included in the study. Multiparametric MRI was performed on all patients and patients with suspicious lesions with Prostate Imaging Reporting and Data System score of 3 or more were randomized into two groups. In the cog-MRGB group, a targeted cognitive biopsy was performed followed by a 12-core SB. Similarly, in the fus-MRGB group, first targeted fusion biopsy and then SBs were performed. The overall and clinically significant prostate cancer detection rates between the two study groups were compared by the Pearson χ 2  test. McNemar test was used to compare detection rates yielded by SB and targeted biopsy in each study group.
RESULTS


One-hundred men in the cog-MRGB group and 99 men in the fus-MRGB group were compared. The baseline characteristics of patients including age, PSA level, prostate volume, PSA density, and clinical stage were similar in the two groups (p > 0.05). Both the overall and clinically significant prostate cancer detection rates in the fus-MRGB group (44.4% and 33.3%, respectively) were significantly higher than cog-MRGB group (31.0% and 19.0%, respectively) (p = 0.035 and p = 0.016, respectively).
CONCLUSION


The accuracy of identifying overall and clinically significant prostate cancer by fus-MRGB in biopsy-naive patients with PSA levels between 2 and 10 ng/dL is significantly higher than cog-MRGB and if available, we recommend using fus-MRGB over cog-MRGB in these patients.",2021,"Both the overall and clinically significant prostate cancer detection rates in the fus-MRGB group (44.4% and 33.3%, respectively) were significantly higher than cog-MRGB group (31.0% and 19.0%, respectively) (p = 0.035 and p = 0.016, respectively).
","['One-hundred men in the cog-MRGB group and 99 men in the fus-MRGB group', 'Biopsy-naive patients with a prostate-specific antigen level between 2 and 10\u2009ng/dL who were candidates for prostate biopsy were included in the study', 'patients and patients with suspicious lesions with Prostate Imaging Reporting and Data System score of 3 or more', 'biopsy-naive patients']","['SB with cog-MRGB in combination with SB', 'magnetic resonance-guided prostate biopsy versus cognitive-guided biopsy', 'MRI-guided targeted biopsy (MRGB) with systematic biopsy (SB']","['prostate cancer detection rates', 'PSA level, prostate volume, PSA density, and clinical stage']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4043426', 'cui_str': 'FUS protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1622900', 'cui_str': 'Data Systems'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}]","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}]",100.0,0.212766,"Both the overall and clinically significant prostate cancer detection rates in the fus-MRGB group (44.4% and 33.3%, respectively) were significantly higher than cog-MRGB group (31.0% and 19.0%, respectively) (p = 0.035 and p = 0.016, respectively).
","[{'ForeName': 'Mohammad-Hossein', 'Initials': 'MH', 'LastName': 'Izadpanahi', 'Affiliation': 'Department of Urology, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amirreza', 'Initials': 'A', 'LastName': 'Elahian', 'Affiliation': 'Department of Urology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Gholipour', 'Affiliation': 'Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. gholipour@med.mui.ac.ir.'}, {'ForeName': 'Mohammad-Hatef', 'Initials': 'MH', 'LastName': 'Khorrami', 'Affiliation': 'Department of Urology, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Zargham', 'Affiliation': 'Department of Urology, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Mohammadi Sichani', 'Affiliation': 'Department of Urology, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Alizadeh', 'Affiliation': 'Department of Urology, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Farbod', 'Initials': 'F', 'LastName': 'Khorrami', 'Affiliation': 'Department of Human Biology, University of Toronto, Toronto, ON, Canada.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-021-00366-9']
741,33913511,"Efficacy of secukinumab and adalimumab in patients with psoriatic arthritis and concomitant moderate-to-severe plaque psoriasis: results from EXCEED, a randomized, double-blind head-to-head monotherapy study.","BACKGROUND


Secukinumab [an interleukin (IL)-17A inhibitor] has demonstrated significantly higher efficacy vs. etanercept (a tumour necrosis factor inhibitor) and ustekinumab (an IL-12/23 inhibitor) in patients with moderate-to-severe plaque psoriasis.
OBJECTIVES


To report 52-week results from a prespecified analysis of patients with active psoriatic arthritis (PsA) having concomitant moderate-to-severe plaque psoriasis from the head-to-head EXCEED monotherapy study comparing secukinumab with adalimumab.
METHODS


Patients were randomized to receive secukinumab 300 mg via subcutaneous injection at baseline, week 1-4, and then every 4 weeks until week 48 or adalimumab 40 mg via subcutaneous injection every 2 weeks from baseline until week 50. Assessments in patients with concomitant moderate-to-severe psoriasis, defined as having affected body surface area > 10% or Psoriasis Area and Severity Index (PASI) ≥ 10 at baseline, included musculoskeletal, skin and quality-of-life outcomes. Missing data were handled using multiple imputation.
RESULTS


Of the 853 patients [secukinumab (N = 426), adalimumab (N = 427)], 211 (24·7%) had concomitant moderate-to-severe psoriasis [secukinumab (N = 110, 25·8%), adalimumab (N = 101, 23·7%)]. Up to week 50, 5·5% of patients discontinued secukinumab vs.17·8% in the adalimumab group. The proportion of patients who achieved American College of Rheumatology (ACR) 20 response was 76·4% with secukinumab vs. 68·3% with adalimumab (P = 0·175), PASI 100 response was 39·1% vs. 23·8% (P = 0·013), and simultaneous improvement in ACR 50 and PASI 100 response at week 52 was 28·2% vs. 17·7%, respectively (P = 0·06). Secukinumab demonstrated consistently higher responses vs. adalimumab across skin endpoints.
CONCLUSIONS


This prespecified analysis in PsA patients with concomitant moderate-to-severe plaque psoriasis in the EXCEED study provides further evidence that IL-17 inhibitors offer a comprehensive biological treatment to manage the concomitant features of psoriasis and PsA.",2021,"Up to Week 50, 5.5% patients discontinued secukinumab vs.17.8% in the adalimumab group.","['patients with active psoriatic arthritis (PsA) having concomitant moderate to severe plaque psoriasis from head-to-head EXCEED monotherapy study comparing secukinumab with adalimumab', 'patients with moderate to severe plaque psoriasis', 'PsA patients with concomitant moderate to severe plaque psoriasis', 'Patients', 'psoriatic arthritis patients with concomitant moderate to severe plaque psoriasis', 'patients with concomitant moderate to severe psoriasis']","['secukinumab 300 mg subcutaneous at baseline', 'adalimumab', 'secukinumab and adalimumab', 'etanercept']","['concomitant moderate to severe psoriasis', 'PASI 100 response', 'simultaneous improvement in ACR50 and PASI 100 response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]",853.0,0.199189,"Up to Week 50, 5.5% patients discontinued secukinumab vs.17.8% in the adalimumab group.","[{'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Merola', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg- Eppendorf, Hamburg, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Behrens', 'Affiliation': 'Rheumatology University Hospital and Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Branch for Translational Medicine and Pharmacology TMP and Fraunhofer Cluster of Excellence for Immune-Mediated Diseases CIMD, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Department of Medicine, Griffith University, Brisbane, QLD, Australia.'}, {'ForeName': 'C E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'The Dermatology Centre, Salford Royal NHS Foundation Trust, NIHR Manchester Biomedical Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bao', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pellet', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pricop', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}]",The British journal of dermatology,['10.1111/bjd.20413']
742,33955628,"Reduction of telogen rate and increase of hair density in androgenetic alopecia by a cosmetic product: Results of a randomized, prospective, vehicle-controlled double-blind study in men.","BACKGROUND


Considerable parts of the global population are affected by androgenetic alopecia (AGA).
AIMS


The efficacy of a foam containing nicotinic acid hexyl ester, polyphenols, zinc, glycine, and caffeine in comparison with a vehicle control foam was assessed in a double-blind vehicle-controlled study in men with AGA over 6 months.
PATIENTS/METHODS


Sixty-two men with AGA were assigned either to the active ingredients (verum) or the vehicle group. They applied the products twice daily on affected scalp areas over 6 months. Automated phototrichograms were obtained at baseline, after 3 and 6 months. In addition, a clinical rating by a dermatologist and by the subjects themselves was documented using standardized questionnaires.
RESULTS


The reduction of the telogen rate from T0 to T6 was significantly stronger in the verum group compared to the vehicle group. The reduction was significant from T0 to T3 and T6 in the verum group, but in the vehicle group only from T0 to T3, not to T6. Significantly increased hair density was noticed in both groups at all time points, but the change from T0 to T6 did not differ significantly between the groups. Cosmetic acceptance of the foam and its application regimen was generally good in both groups. Slight reddening and burning after application of verum in six cases was probably due to the presence of hexyl nicotinate.
CONCLUSION


The study demonstrated a reduction of the telogen rate by a cosmetic foam in men affected by AGA, indicating a benefit for cosmetic intervention against male pattern hair loss.",2022,"Significantly increased hair density was noticed in both groups at all time points, but the change from T0 to T6 did not differ significantly between the groups.","['men with AGA over 6\xa0months', 'Sixty-two men with AGA', 'men']","['foam containing nicotinic acid hexyl ester, polyphenols, zinc, glycine, and caffeine']","['hair density', 'Cosmetic acceptance', 'telogen rate', 'reduction of the telogen rate']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517835', 'cui_str': '62'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0062684', 'cui_str': 'Hexyl nicotinate'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",62.0,0.224918,"Significantly increased hair density was noticed in both groups at all time points, but the change from T0 to T6 did not differ significantly between the groups.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Welzel', 'Affiliation': 'Department of Dermatology and Allergology, University Hospital Augsburg, Augsburg, Germany.'}, {'ForeName': 'Helmut H', 'Initials': 'HH', 'LastName': 'Wolff', 'Affiliation': 'Department of Dermatology and Venerology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Gehring', 'Affiliation': 'Department of Dermatology, Municipal Clinics Karlsruhe, Karlsruhe, Germany.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14158']
743,33914418,Analysis of Feasibility and Acceptability of an E-Learning Module in Anatomy.,"Recent advance in medical education is in correlation with the advances in information technology and thus computer-based learning is being increasingly employed. The objective of the present study was to design and evaluate an e-learning module in anatomy and assess the perceptions of students and faculty about this e-learning module. The participating students were randomized into three groups by block stratified randomization and Google groups were created for each of the three groups. The e-learning module was implemented in three sessions by rotating the three groups. Validated questionnaires were sent to faculty and participating students via Google forms to obtain feedback. The results of ANOVA showed that there was a significant difference among the groups in terms of marks obtained with conventional (F = 2.403, P = 0.103), online (F = 6.050, P = 0.005), and blended (F = 5.801, P = 0.006). Post hoc comparisons using the Tukey HSD test, about the gain of knowledge, indicated that the results were insignificant when comparing the conventional group with the online group, but were significant when comparing the blended group with the conventional and online group. The qualitative data regarding the perception of students toward e-learning were analyzed using thematic analysis. The introduction of an interactive e-learning module in anatomy was effective and well received by the students and faculty. The study showed that blended learning has a positive impact on the students' learning by improving cognitive gain and receptive perception for e-learning.",2022,"The results of ANOVA showed that there was a significant difference among the groups in terms of marks obtained with conventional (F = 2.403, P = 0.103), online (F = 6.050, P = 0.005), and blended (F = 5.801, P = 0.006).",[],['blended learning'],['cognitive gain and receptive perception'],[],"[{'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.038573,"The results of ANOVA showed that there was a significant difference among the groups in terms of marks obtained with conventional (F = 2.403, P = 0.103), online (F = 6.050, P = 0.005), and blended (F = 5.801, P = 0.006).","[{'ForeName': 'Ghulam Mohammad', 'Initials': 'GM', 'LastName': 'Bhat', 'Affiliation': 'Postgraduate Department of Anatomy, Government Medical College Srinagar, Srinagar, India.'}, {'ForeName': 'Ishfaq Hussain', 'Initials': 'IH', 'LastName': 'Bhat', 'Affiliation': 'Department of Management Studies, Islamic University of Science and Technology Awantipora, Pulwama, India.'}, {'ForeName': 'Shaheen', 'Initials': 'S', 'LastName': 'Shahdad', 'Affiliation': 'Postgraduate Department of Anatomy, Government Medical College Srinagar, Srinagar, India.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Rashid', 'Affiliation': 'Postgraduate Department of Anatomy, Government Medical College Srinagar, Srinagar, India.'}, {'ForeName': 'Mudasir Ahmad', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Postgraduate Department of Anatomy, Government Medical College Srinagar, Srinagar, India.'}, {'ForeName': 'Ajaz Ahmad', 'Initials': 'AA', 'LastName': 'Patloo', 'Affiliation': 'Postgraduate Department of Anatomy, Government Medical College Srinagar, Srinagar, India.'}]",Anatomical sciences education,['10.1002/ase.2096']
744,33929674,Musical Auditory Alpha Wave Neurofeedback: Validation and Cognitive Perspectives.,"Neurofeedback through visual, auditory, or tactile sensations improves cognitive functions and alters the activities of daily living. However, some people, such as children and the elderly, have difficulty concentrating on neurofeedback for a long time. Constant stressless neurofeedback for a long time may be achieved with auditory neurofeedback using music. The primary purpose of this study was to clarify whether music-based auditory neurofeedback increases the power of the alpha wave in healthy subjects. During neurofeedback, white noise was superimposed on classical music, with the noise level inversely correlating with normalized alpha wave power. This was a single-blind, randomized control crossover trial in which 10 healthy subjects underwent, in an assigned order, normal and random feedback (NF and RF), either of which was at least 4 weeks long. Cognitive functions were evaluated before, between, and after each neurofeedback period. The secondary purpose was to assess neurofeedback-induced changes in cognitive functions. A crossover analysis showed that normalized alpha-power was significantly higher in NF than in RF; therefore, music-based auditory neurofeedback facilitated alpha wave induction. A composite category-based analysis of cognitive functions revealed greater improvements in short-term memory in subjects whose alpha-power increased in response to NF. The present study employed a long period of auditory alpha neurofeedback and achieved successful alpha wave induction and subsequent improvements in cognitive functions. Although this was a pilot study that validated a music-based alpha neurofeedback system for healthy subjects, the results obtained are encouraging for those with difficulty in concentrating on conventional alpha neurofeedback.Trial registration: 2018077NI, date of registration: 2018/11/27.",2021,A composite category-based analysis of cognitive functions revealed greater improvements in short-term memory in subjects whose alpha-power increased in response to NF.,"['healthy subjects', '10 healthy subjects']",['music-based auditory neurofeedback'],"['cognitive functions', 'normalized alpha-power', 'Neurofeedback through visual, auditory, or tactile sensations improves cognitive functions and alters the activities of daily living', 'Cognitive functions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0702221', 'cui_str': 'Touch sensation, function'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",10.0,0.0172567,A composite category-based analysis of cognitive functions revealed greater improvements in short-term memory in subjects whose alpha-power increased in response to NF.,"[{'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Takabatake', 'Affiliation': 'Department of Neurosurgery, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kunii', 'Affiliation': 'Department of Neurosurgery, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Nakatomi', 'Affiliation': 'Department of Neurosurgery, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. hnakatomi-tky@umin.ac.jp.'}, {'ForeName': 'Seijiro', 'Initials': 'S', 'LastName': 'Shimada', 'Affiliation': 'Department of Neurosurgery, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Yanai', 'Affiliation': 'Department of Neurosurgery, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Takasago', 'Affiliation': 'Department of Neurosurgery, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Nobuhito', 'Initials': 'N', 'LastName': 'Saito', 'Affiliation': 'Department of Neurosurgery, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-021-09507-1']
745,33866020,Targeting location relates to treatment response in active but not sham rTMS stimulation.,"BACKGROUND


Precise targeting of brain functional networks is believed critical for treatment efficacy of rTMS (repetitive pulse transcranial magnetic stimulation) in treatment resistant major depression.
OBJECTIVE


To use imaging data from a ""failed"" clinical trial of rTMS in Veterans to test whether treatment response was associated with rTMS coil location in active but not sham stimulation, and compare fMRI functional connectivity between those stimulation locations.
METHODS


An imaging substudy of 49 Veterans (mean age, 56 years; range, 27-78 years; 39 male) from a randomized, sham-controlled, double-blinded clinical trial of rTMS treatment, grouping participants by clinical response, followed by group comparisons of treatment locations identified by individualized fiducial markers on structural MRI and resting state fMRI derived networks.
RESULTS


The average stimulation location for responders versus nonresponders differed in the active but not in the sham condition (P = .02). The average responder location derived from the active condition showed significant negative functional connectivity with the subgenual cingulate (P < .001) while the nonresponder location did not (P = .17), a finding replicated in independent cohorts of 84 depressed and 35 neurotypical participants. The responder and nonresponder stimulation locations evoked different seed based networks (FDR corrected clusters, all P < .03), revealing additional brain regions related to rTMS treatment outcome.
CONCLUSION


These results provide evidence from a randomized controlled trial that clinical response to rTMS is related to accuracy in targeting the region within DLPFC that is negatively correlated with subgenual cingulate. These results support the validity of a neuro-functionally informed rTMS therapy target in Veterans.",2021,"The responder and nonresponder stimulation locations evoked different seed based networks (FDR corrected clusters, all P < .03), revealing additional brain regions related to rTMS treatment outcome.
","['49 Veterans (mean age, 56 years; range, 27-78 years; 39 male']","['rTMS', 'rTMS (repetitive pulse transcranial magnetic stimulation']","['average stimulation location', 'fMRI functional connectivity', 'negative functional connectivity']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",84.0,0.183334,"The responder and nonresponder stimulation locations evoked different seed based networks (FDR corrected clusters, all P < .03), revealing additional brain regions related to rTMS treatment outcome.
","[{'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Rosen', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA; Department of Psychiatry, Stanford University, Stanford, CA, 94305, USA. Electronic address: rosena@stanford.edu.'}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Bhat', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA; Palo Alto Veterans Institute for Research, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Cardenas', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Ehrlich', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA; University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Horwege', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'Mental Health Service, San Francisco Veterans Affairs Health Care System, University of California, San Francisco, CA, USA; Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Roach', 'Affiliation': 'Mental Health Service, San Francisco Veterans Affairs Health Care System, University of California, San Francisco, CA, USA; Northern California Institute for Research and Education, San Francisco Veterans Affairs Medical Center, University of California, San Francisco, CA, USA.'}, {'ForeName': 'G H', 'Initials': 'GH', 'LastName': 'Glover', 'Affiliation': 'Department of Radiology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Badran', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Forman', 'Affiliation': 'Department of Veterans Affairs, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA; Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, USA.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'VISN4 Mental Illness Research, Education, and Clinical Center at the Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, 19104, USA; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Yurgelun-Todd', 'Affiliation': 'Rocky Mountain Network Mental Illness Research Education and Clinical Centers (VISN 19), VA Salt Lake City Health Care System, Salt Lake City, UT, USA; Department of Psychiatry, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Sughrue', 'Affiliation': 'Omniscient Neurotechnologies, Sydney, Australia; Prince of Wales Hospital, Randwick, NSW, Australia.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Doyen', 'Affiliation': 'Omniscient Neurotechnologies, Sydney, Australia.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Nicholas', 'Affiliation': 'Omniscient Neurotechnologies, Sydney, Australia.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Scott', 'Affiliation': 'VISN4 Mental Illness Research, Education, and Clinical Center at the Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, 19104, USA; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Department of Biomedical Data Science, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Yesavage', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA; Department of Psychiatry, Stanford University, Stanford, CA, 94305, USA.'}]",Brain stimulation,['10.1016/j.brs.2021.04.010']
746,33947501,The effect of playing games with toys made with medical materials in children with cancer on pain during intravenous treatment.,"OBJECTIVE


This research aims to examine the effect of playing games with toys made of medical materials in children with cancer on pain that occurs during intravenous (IV) treatment.
METHODS


The randomized controlled clinical trial was conducted between May 2016 and February 2018. The study sample comprised 110 children (experimental group 55; control group 55), determined using power analysis from the study population. The data were collected by the researcher, using face-to-face interview techniques, the Information Form, and Wong-Baker FACES Pain Rating Scale (WBS).
RESULTS


The pre- and post-test pain mean scores of patients in the experimental group were 2.27 ± 0.91 and 0.43 ± 0.66, respectively (p = 0.0001). The pre- and post-test pain mean scores of patients in the control group were 1.72 ± 0.82 and 3.34 ± 0.77, respectively (p = 0.0001).
SIGNIFICANCE OF RESULTS


The experience of playing with toys made from materials used for invasive procedures relieves pain the during IV treatment.",2022,"The pre- and post-test pain mean scores of patients in the control group were 1.72 ± 0.82 and 3.34 ± 0.77, respectively (p = 0.0001).
","['children with cancer on pain during intravenous treatment', 'May 2016 and February 2018', '110 children (experimental group 55; control group 55), determined using power analysis from the study population', 'children with cancer on pain that occurs during intravenous (IV) treatment']",['playing games with toys made with medical materials'],"['pre- and post-test pain mean scores', 'Baker FACES Pain Rating Scale (WBS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0040565', 'cui_str': 'Toy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0740768,"The pre- and post-test pain mean scores of patients in the control group were 1.72 ± 0.82 and 3.34 ± 0.77, respectively (p = 0.0001).
","[{'ForeName': 'Hakime', 'Initials': 'H', 'LastName': 'Aslan', 'Affiliation': 'Department of Fundamentals of Nursing, Faculty of Nursing, Inonu University, Malatya44280, Turkey.'}, {'ForeName': 'Behice', 'Initials': 'B', 'LastName': 'Erci', 'Affiliation': 'Department of Public Health Nursing, Faculty of Nursing, Inonu University, Malatya44280, Turkey.'}]",Palliative & supportive care,['10.1017/S1478951521000390']
747,33928209,Molecular Profiling-Based Assignment of Cancer Therapy (NCI-MPACT): A Randomized Multicenter Phase II Trial.,"This trial assessed the utility of applying tumor DNA sequencing to treatment selection for patients with advanced, refractory cancer and somatic mutations in one of four signaling pathways by comparing the efficacy of four study regimens that were either matched to the patient's aberrant pathway (experimental arm) or not matched to that pathway (control arm).
MATERIALS AND METHODS


Adult patients with an actionable mutation of interest were randomly assigned 2:1 to receive either (1) a study regimen identified to target the aberrant pathway found in their tumor (veliparib with temozolomide or adavosertib with carboplatin [DNA repair pathway], everolimus [PI3K pathway], or trametinib [RAS/RAF/MEK pathway]), or (2) one of the same four regimens, but chosen from among those not targeting that pathway.
RESULTS


Among 49 patients treated in the experimental arm, the objective response rate was 2% (95% CI, 0% to 10.9%). One of 20 patients (5%) in the experimental trametinib cohort had a partial response. There were no responses in the other cohorts. Although patients and physicians were blinded to the sequencing and random assignment results, a higher pretreatment dropout rate was observed in the control arm (22%) compared with the experimental arm (6%;  P  = .038), suggesting that some patients may have had prior tumor mutation profiling performed that led to a lack of participation in the control arm.
CONCLUSION


Further investigation, better annotation of predictive biomarkers, and the development of more effective agents are necessary to inform treatment decisions in an era of precision cancer medicine. Increasing prevalence of tumor mutation profiling and preference for targeted therapy make it difficult to use a randomized phase II design to evaluate targeted therapy efficacy in an advanced disease setting.",2021,"Among 49 patients treated in the experimental arm, the objective response rate was 2% (95% CI, 0% to 10.9%).","[""patients with advanced, refractory cancer and somatic mutations in one of four signaling pathways by comparing the efficacy of four study regimens that were either matched to the patient's aberrant pathway (experimental arm) or not matched to that pathway (control arm"", 'Adult patients with an actionable mutation of interest']","['Cancer Therapy (NCI-MPACT', 'aberrant pathway found in their tumor (veliparib with temozolomide or adavosertib with carboplatin [DNA repair pathway], everolimus [PI3K pathway], or trametinib [RAS/RAF/MEK pathway']","['objective response rate', 'partial response', 'dropout rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0677936', 'cui_str': 'Refractory cancer'}, {'cui': 'C0544886', 'cui_str': 'Somatic mutation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C1958300', 'cui_str': 'veliparib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012899', 'cui_str': 'DNA repair'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0044602', 'cui_str': '1-phosphatidylinositol 3-kinase'}, {'cui': 'C0169101', 'cui_str': 'MAP Kinase Kinases'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}]",,0.0413271,"Among 49 patients treated in the experimental arm, the objective response rate was 2% (95% CI, 0% to 10.9%).","[{'ForeName': 'Alice P', 'Initials': 'AP', 'LastName': 'Chen', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Shivaani', 'Initials': 'S', 'LastName': 'Kummar', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Moore', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Lawrence V', 'Initials': 'LV', 'LastName': 'Rubinstein', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Yingdong', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'P Mickey', 'Initials': 'PM', 'LastName': 'Williams', 'Affiliation': 'Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Palmisano', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sims', 'Affiliation': 'Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': ""O'Sullivan Coyne"", 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Rosenberger', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Mel', 'Initials': 'M', 'LastName': 'Simpson', 'Affiliation': 'Applied/Developmental Research Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Kanwal P S', 'Initials': 'KPS', 'LastName': 'Raghav', 'Affiliation': 'Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Meric-Bernstam', 'Affiliation': 'Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Leong', 'Affiliation': 'University of Colorado Cancer Center, Aurora, CO.'}, {'ForeName': 'Saiama', 'Initials': 'S', 'LastName': 'Waqar', 'Affiliation': 'Department of Medical Oncology, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Jared C', 'Initials': 'JC', 'LastName': 'Foster', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Mariam M', 'Initials': 'MM', 'LastName': 'Konaté', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Biswajit', 'Initials': 'B', 'LastName': 'Das', 'Affiliation': 'Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Karlovich', 'Affiliation': 'Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Chih-Jian', 'Initials': 'CJ', 'LastName': 'Lih', 'Affiliation': 'Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Polley', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Simon', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Ming-Chung', 'Initials': 'MC', 'LastName': 'Li', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Piekarz', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Doroshow', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.'}]",JCO precision oncology,['10.1200/PO.20.00372']
748,33940595,"Investigating the Effects of Threatening Language, Message Framing, and Reactance in Opt-Out Organ Donation Campaigns.","BACKGROUND


Under opt-out organ donation policies, individuals are automatically considered to have agreed to donate their organs in the absence of a recorded opt-out decision. Growing evidence suggests that the language used within organ donation campaigns influences donor intentions and decision-making.
PURPOSE


As awareness campaigns to promote opt-out consent in the UK are ongoing, the objectives of this study were to investigate the effect of language and message framing used in opt-out organ donation campaigns on donor intentions and psychological reactance.
METHODS


Individuals from Scotland and England (N = 1,350) completed this online experiment. Participants were randomized to view one of four messages, designed in the format of a newspaper article, which described the upcoming opt-out system. This followed a 2 × 2 design whereby the degree of threatening language (high threat vs. low threat) and message framing (loss vs. gain) of the newspaper article was experimentally manipulated. Measures of intention (pre-exposure and postexposure) and postmessage reactance (threat to freedom and anger and counter-arguing) were obtained.
RESULTS


A mixed analysis of variance revealed a significant Group × Time interaction on donor intentions; post hoc analysis revealed that intentions significantly decreased for individuals exposed to the High threat × Loss frame article but significantly increased for those exposed to the High threat × Gain frame article.
CONCLUSIONS


In campaigns to promote opt-out legislation, high-threat language combined with loss-frame messages should be avoided. If high-threat language is used, gain-frame messaging that highlights the benefits of organ donation should also be incorporated.",2022,"Measures of intention (pre-exposure and postexposure) and postmessage reactance (threat to freedom and anger and counter-arguing) were obtained.
","['Individuals from Scotland and England (N = 1,350']",[],['Measures of intention (pre-exposure and postexposure) and postmessage reactance (threat to freedom and anger and counter-arguing'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0014282', 'cui_str': 'England'}]",[],"[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0677601', 'cui_str': 'Counter'}]",1350.0,0.0464964,"Measures of intention (pre-exposure and postexposure) and postmessage reactance (threat to freedom and anger and counter-arguing) were obtained.
","[{'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Division of Psychology, Faculty of Natural Sciences, University of Stirling, Stirling FK9 4LA, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'McGregor', 'Affiliation': 'Division of Psychology, Faculty of Natural Sciences, University of Stirling, Stirling FK9 4LA, UK.'}, {'ForeName': 'Sinéad', 'Initials': 'S', 'LastName': 'Currie', 'Affiliation': 'Division of Psychology, Faculty of Natural Sciences, University of Stirling, Stirling FK9 4LA, UK.'}, {'ForeName': 'Ronan E', 'Initials': 'RE', 'LastName': ""O'Carroll"", 'Affiliation': 'Division of Psychology, Faculty of Natural Sciences, University of Stirling, Stirling FK9 4LA, UK.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaab017']
749,33905129,Safety of the standardized quality tree sublingual immunotherapy tablet: Pooled safety analysis of clinical trials.,"BACKGROUND


The standardized quality (SQ) tree sublingual immunotherapy (SLIT)-tablet has recently been approved for treatment of tree pollen allergy. Healthcare workers should be provided with detailed safety data for clinical use.
OBJECTIVE


To assess the tolerability and safety of the SQ tree SLIT-tablet (12 SQ-Bet) in adults and adolescents.
METHODS


Safety data were pooled from three double-blinded, randomized, placebo-controlled trials (2 phase-II/1 phase-III) including adults and adolescents 12-65 years with allergic rhinitis and/or conjunctivitis treated before and during one pollen season once-daily with 12 SQ-Bet (n = 471) or placebo (n = 458): EudraCT no: 2012-000031-59; NCT02481856; EudraCT 2015-004821-15.
RESULTS


The most frequently reported investigational medicinal product (IMP)-related AEs with 12 SQ-Bet were oral pruritis (39% of subjects) and throat irritation (29%). IMP-related AEs were mainly mild or moderate in severity, and the majority resolved without treatment and did not lead to treatment interruption/discontinuation. With 12 SQ-Bet, oral pruritus was more frequent among subjects with pollen food syndrome (PFS) (45%) than without PFS (29%). The 12 SQ-Bet did not seem to induce an increased risk of asthma: 7 events were reported in 7 subjects with 12 SQ-Bet and 11 in 10 subjects with placebo. No differences were seen in the risk of moderate-to-severe IMP-related AEs regardless of age, PFS status and asthma medical history.
CONCLUSIONS


The 12 SQ tree SLIT-tablet was well tolerated in tree pollen allergic subjects with no major safety concerns detected. This safety profile supports daily at-home sublingual administration once the first dose is tolerated when administered under medical supervision.",2021,"No differences were seen in the risk of moderate to severe IMP-related AEs regardless of age, PFS status and asthma medical history.
","['Health care workers', 'adults and adolescents 12-65 years with allergic rhinitis and/orconjunctivitis treated before and during one pollen season once-daily with 12 SQ-Bet (n=471) or', '12 SQ-Bet)in adults and adolescents']","['placebo', 'SQ tree SLIT-tablet']","['risk of asthma', 'tolerability and safety']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0032385', 'cui_str': 'Pollen'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040811', 'cui_str': 'Tree'}, {'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",7.0,0.0940057,"No differences were seen in the risk of moderate to severe IMP-related AEs regardless of age, PFS status and asthma medical history.
","[{'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Biedermann', 'Affiliation': 'Department of Dermatology and Allergology, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Couroux', 'Affiliation': 'Inflamax Research Inc, Mississauga, ON, Canada.'}, {'ForeName': 'Tina Maria', 'Initials': 'TM', 'LastName': 'Greve', 'Affiliation': 'Global Clinical Development, ALK, Hørsholm, Denmark.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Mäkelä', 'Affiliation': 'Inflammatory Diseases, Skin and Allergy Hospital, Helsinki University Central Hospital, Helsinki, Finland.'}]",Allergy,['10.1111/all.14882']
750,33902333,Adaptations to Acupuncture and Pain Counseling Implementation in a Multisite Pragmatic Randomized Clinical Trial.,"Objectives:  As part of a pragmatic effectiveness trial of integrative pain management among inpatients with cancer, the authors sought to understand the clinical context and adaptations to implementation of two study interventions, acupuncture and pain counseling (i.e., pain education and coping skills).  Design:  The larger study uses a 2 × 2 factorial design with inpatients randomized to: (1) usual care (UC), (2) UC with acupuncture, (3) UC with pain counseling, and (4) UC with acupuncture and pain counseling. The study is being conducted in two hospitals (one academic and one public) and three languages (Cantonese, English, and Spanish). The authors conducted a process evaluation by interviewing study interventionists. Analysis included deductive coding to describe context, intervention, implementation, and inductive thematic coding related to intervention delivery.  Results:  Interviewees included seven acupuncturists and four pain counselors. Qualitative themes covered adaptations and recognizing site-specific differences that affected implementation. Interventionists adhered closely to protocols and made patient-centered adaptations that were then standardized in broader implementation (e.g., including caregivers in pain counseling sessions; working in culturally nuanced ways with non-English-speaking patients). The public hospital included more patients with recent diagnoses and advanced disease, more ethnically and linguistically diverse patients, less continuity of staffing, and shared patient rooms. At the academic medical center, more patients were familiar with integrative therapies and all were located in single rooms. Providing acupuncture to hospital staff was a key strategy to establish trust, experientially explain the intervention, and create camaraderie and staff buy-in.  Conclusions:  Providing nonpharmacologic interventions for a pragmatic trial requires adapting to a range of clinical factors. Site-specific factors included greater coordination and resources needed for successful implementation in the public hospital. The authors conclude that adaptation to context and individual patient needs can be done without compromising intervention fidelity and that intervention design should apply principles such as centering at the margins to reduce participation barriers for diverse patient populations.",2021,"Providing acupuncture to hospital staff was a key strategy to establish trust, experientially explain the intervention, and create camaraderie and staff buy-in.  ","['two hospitals (one academic and one public) and three languages (Cantonese, English, and Spanish', 'inpatients with cancer', 'patients with recent diagnoses and advanced disease, more ethnically and linguistically diverse patients, less continuity of staffing, and shared patient rooms']","['Acupuncture and Pain Counseling Implementation', 'acupuncture and pain counseling (i.e., pain education and coping skills', 'usual care (UC), (2) UC with acupuncture, (3) UC with pain counseling, and (4) UC with acupuncture and pain counseling', 'integrative pain management']","['deductive coding to describe context, intervention, implementation, and inductive thematic coding related to intervention delivery']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0030707', 'cui_str': ""Client's room""}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",7.0,0.0550248,"Providing acupuncture to hospital staff was a key strategy to establish trust, experientially explain the intervention, and create camaraderie and staff buy-in.  ","[{'ForeName': 'Evelyn Y', 'Initials': 'EY', 'LastName': 'Ho', 'Affiliation': 'Department of Communication Studies, University of San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Thompson-Lastad', 'Affiliation': 'Osher Center for Integrative Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Rachele', 'Initials': 'R', 'LastName': 'Lam', 'Affiliation': 'Osher Center for Integrative Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Osher Center for Integrative Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Thompson', 'Affiliation': 'Osher Center for Integrative Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Chao', 'Affiliation': 'Osher Center for Integrative Medicine, University of California, San Francisco, San Francisco, CA, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0387']
751,33938071,Decrease in CD38 +  TH2A cell frequencies following immunotherapy with house dust mite tablet correlates with humoral responses.,"BACKGROUND


In line with evidence for a role of pathogenic TH2A in seasonal allergies, we previously showed that individuals suffering from food allergy exhibited a decrease in circulating TH2A cells following multi-food immunotherapy. Herein, we aim to confirm the decline of TH2A cells in individuals undergoing house dust mite immunotherapy (HDM-AIT) and extend our observation to a new subset of CD38 expressing activated TH2A cells.
METHODS


The frequencies of TH2A and CD38 +  TH2A cells were analysed by flow cytometry in blood cells from 182 Japanese HDM-allergic individuals included in a 1-year clinical trial assessing the efficacy of HDM tablets. Interrelationship between these cellular responses and humoral mite-specific IgE and IgG4 levels was further explored.
RESULTS


A decrease in TH2A cells was observed in both active and placebo groups. Interestingly, CD38 +  TH2A cell frequencies significantly decreased only in active groups. In younger individuals (16-30 years), both TH2A and CD38 +  TH2A cells were significantly reduced in active groups but not in the placebo group. Significant inverse correlations were observed in the course of HDM-AIT between changes in TH2A or CD38 +  TH2A frequencies and IgG4 antibody levels.
CONCLUSIONS


We confirm the value of monitoring TH2A cell frequencies in allergic individuals and extend this observation to perennial allergy to HDM. We highlight the interest of CD38 to better identify the subset of TH2A cell down-regulated by AIT. Finally, correlated cellular and humoral responses observed in immunoreactive individuals stress that coordinated pathways occur in the adaptive responses during AIT.",2021,"Significant inverse correlations were observed in the course of HDM-AIT between changes in TH2A or CD38+ TH2A frequencies and IgG4 antibody levels.
","['individuals undergoing house dust mite immunotherapy (HDM-AIT', '182 Japanese HDM-allergic individuals', 'allergic individuals']",['placebo'],"['CD38 +  TH2A cell frequencies', 'TH2A and CD38+ TH2A cells', 'TH2A cells', 'CD38+ TH2A cell frequencies', 'frequencies of TH2A and CD38+ TH2A cells', 'circulating TH2A cells']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0075742', 'cui_str': 'Lymphocyte antigen CD38'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",,0.0827544,"Significant inverse correlations were observed in the course of HDM-AIT between changes in TH2A or CD38+ TH2A frequencies and IgG4 antibody levels.
","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Luce', 'Affiliation': 'Stallergenes Greer, Antony, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Batard', 'Affiliation': 'Stallergenes Greer, Antony, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Bordas-Le Floch', 'Affiliation': 'Stallergenes Greer, Antony, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Le Gall', 'Affiliation': 'Stallergenes Greer, Antony, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mascarell', 'Affiliation': 'Stallergenes Greer, Antony, France.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13891']
752,33941737,"Behavioral and Socioemotional Outcomes of the Legacy for Children™ Randomized Control Trial to Promote Healthy Development of Children Living in Poverty, 4 to 6 Years Postintervention.","OBJECTIVE


The objective of this article was to assess the impact on behavioral and socioemotional development, 4 to 6 years postintervention (depending on the curriculum), of Legacy for Children™, a public health approach to improve child developmental outcomes among families living in poverty.
METHODS


Mothers who were recruited prenatally or at the time of childbirth participated in a set of Legacy parallel design randomized control trials between 2001 and 2009 in Miami, Florida, or Los Angeles, California. Of the initial 574 mother-child dyads, 364 completed at least 1 behavioral or socioemotional outcome measure at the third-grade follow-up. Intention-to-treat analyses compared Legacy and comparison groups on behavioral and socioemotional outcomes.
RESULTS


Children of Legacy mothers in Los Angeles were at lower risk for externalizing behaviors and poor adaptive skills than children whose mothers did not participate in the intervention. No significant outcome differences by group assignment were found in Miami.
CONCLUSION


Group-based positive parenting interventions such as Legacy may have a sustained impact on children's behavioral and socioemotional development several years after intervention completion.",2022,"No significant outcome differences by group assignment were found in Miami.
","['families living in poverty', 'Mothers who were recruited prenatally or at the time of childbirth participated in a set of Legacy parallel design randomized control trials between 2001 and 2009 in Miami, Florida, or Los Angeles, California', 'Children Living in Poverty, 2 to 6 Years Postintervention']",[],"['Miami', 'externalizing behaviors and poor adaptive skills']","[{'cui': 'C0557130', 'cui_str': 'Lives with family'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0242538', 'cui_str': 'Inheritance'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",,0.0858983,"No significant outcome differences by group assignment were found in Miami.
","[{'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Barry', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Lara R', 'Initials': 'LR', 'LastName': 'Robinson', 'Affiliation': 'National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Chamblee, GA.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Kaminski', 'Affiliation': 'National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Chamblee, GA.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Danielson', 'Affiliation': 'National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Chamblee, GA.'}, {'ForeName': 'Corey L', 'Initials': 'CL', 'LastName': 'Jones', 'Affiliation': 'Booz Allen Hamilton, Atlanta, GA.'}, {'ForeName': 'Delia L', 'Initials': 'DL', 'LastName': 'Lang', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000962']
753,33944909,Change in Dysfunctional Sleep-Related Beliefs is Associated with Changes in Sleep and Other Health Outcomes Among Older Veterans With Insomnia: Findings From a Randomized Controlled Trial.,"BACKGROUND


Cognitive behavioral therapy for insomnia (CBTI) targets changing dysfunctional sleep-related beliefs. The impact of these changes on daytime functioning in older adults is unknown.
PURPOSE


We examined whether changes in sleep-related beliefs from pre- to post-CBTI predicted changes in sleep and other outcomes in older adults.
METHOD


Data included 144 older veterans with insomnia from a randomized controlled trial testing CBTI. Sleep-related beliefs were assessed with the Dysfunctional Beliefs and Attitudes about Sleep-16 (DBAS-16, subscales: Consequences, Worry/Helplessness, Sleep Expectations, Medication). Outcomes included sleep diary variables, actigraphy-measured sleep efficiency, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), Flinders Fatigue Scale (FFS), Patient Health Questionnaire-9, and health-related quality of life. Analyses compared slope of change in DBAS subscales from baseline to posttreatment between CBTI and control, and assessed the relationship between DBAS change and the slope of change in outcomes from baseline to 6 months.
RESULTS


Compared to controls, the CBTI group demonstrated stronger associations between improvement in DBAS-Consequences and subsequent improvement in PSQI, ISI, ESS, and FFS. The CBTI group also demonstrated stronger associations between improvement in DBAS-Worry/Helplessness and subsequent improvements in PSQI, ISI, and FFS; improvements in DBAS-Medication and PSQI; and improvements in DBAS-Sleep Expectations and wake after sleep onset (sleep diary) and FFS (all p < .05).
CONCLUSIONS


Significant reduction in dysfunctional sleep-related beliefs following CBTI in older adults predicted improvement in several outcomes of sleep and daytime functioning. This suggests the importance of addressing sleep-related beliefs for sustained improvement with CBTI in older veterans.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT00781963.",2022,"Compared to controls, the CBTI group demonstrated stronger associations between improvement in DBAS-Consequences and subsequent improvement in PSQI, ISI, ESS, and FFS.","['144 older veterans with insomnia from a randomized controlled trial testing CBTI', 'Older Veterans With Insomnia', 'older adults', 'older veterans']",['Cognitive behavioral therapy'],"['sleep diary variables, actigraphy-measured sleep efficiency, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), Flinders Fatigue Scale (FFS), Patient Health Questionnaire-9, and health-related quality of life', 'dysfunctional sleep-related beliefs', 'daytime functioning', 'Sleep-related beliefs', 'DBAS-Worry/Helplessness and subsequent improvements in PSQI, ISI, and FFS; improvements in DBAS-Medication and PSQI; and improvements in DBAS-Sleep Expectations and wake after sleep onset (sleep diary) and FFS', 'Dysfunctional Beliefs and Attitudes about Sleep-16 (DBAS-16, subscales: Consequences, Worry/Helplessness, Sleep Expectations, Medication', 'DBAS-Consequences and subsequent improvement in PSQI, ISI, ESS, and FFS', 'DBAS subscales']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0025923', 'cui_str': 'Mouse, Inbred DBA'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0018897', 'cui_str': 'Learned Helplessness'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}]",,0.136882,"Compared to controls, the CBTI group demonstrated stronger associations between improvement in DBAS-Consequences and subsequent improvement in PSQI, ISI, ESS, and FFS.","[{'ForeName': 'Yeonsu', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'School of Nursing, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Monica R', 'Initials': 'MR', 'LastName': 'Kelly', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, VA Greater Los Angeles Healthcare System, CAUSA.'}, {'ForeName': 'Constance H', 'Initials': 'CH', 'LastName': 'Fung', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, VA Greater Los Angeles Healthcare System, CAUSA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Dzierzewski', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Grinberg', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, VA Greater Los Angeles Healthcare System, CAUSA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Mitchell', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, VA Greater Los Angeles Healthcare System, CAUSA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Josephson', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, VA Greater Los Angeles Healthcare System, CAUSA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Martin', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, VA Greater Los Angeles Healthcare System, CAUSA.'}, {'ForeName': 'Cathy A', 'Initials': 'CA', 'LastName': 'Alessi', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, VA Greater Los Angeles Healthcare System, CAUSA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaab030']
754,33937580,Comparing written exposure therapy to Prolonged Exposure for the treatment of PTSD in a veteran sample: A non-inferiority randomized design.,"Posttraumatic stress disorder (PTSD) is highly prevalent among veterans. Although there are effective treatment approaches for PTSD, such as Prolonged Exposure (PE) and Cognitive Processing Therapy, many providers trained in these approaches do not use them, or use them without sufficient fidelity, and veterans drop out of these treatments at very high rates. The time intensive nature of these treatments is frequently cited as a barrier to receiving the treatment among veterans and delivering the treatment among providers. According, there is an urgent need to establish more efficient and effective PTSD treatment approaches in order to meet the needs of veterans seeking care. Written exposure therapy (WET) is an efficient, exposure-based treatment, and may represent a plausible alternative treatment option to address PTSD in veterans. Although WET has been found to be effective and non-inferior to more time intensive trauma-focused treatment, it has not yet been investigated with a veteran sample. In an ongoing randomized controlled trial (RCT) we are investigating whether WET is non-inferior in treating PTSD compared with the more time intensive PE. The study sample will include 150 men and women veterans diagnosed with PTSD who are randomly assigned to either WET ( n  = 75) or PE ( n  = 75). Participants are assessed prior to treatment and 10-, 20-, and 30-weeks after the first treatment session. The primary outcome is PTSD symptom severity assessed with the Clinician Administered PTSD Scale for DSM-5. Establishing that PTSD can be treated effectively with fewer treatment sessions would represent a significant advance in improving access to evidence-based care for veterans with PTSD.",2021,"Written exposure therapy (WET) is an efficient, exposure-based treatment, and may represent a plausible alternative treatment option to address PTSD in veterans.","['Posttraumatic stress disorder (PTSD', '150 men and women veterans diagnosed with PTSD', 'veterans with PTSD']","['Written exposure therapy (WET', 'PE', 'WET']",['PTSD symptom severity assessed with the Clinician Administered PTSD Scale for DSM-5'],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}]",150.0,0.0261779,"Written exposure therapy (WET) is an efficient, exposure-based treatment, and may represent a plausible alternative treatment option to address PTSD in veterans.","[{'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Sloan', 'Affiliation': 'National Center for PTSD, Boston Healthcare System, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Marx', 'Affiliation': 'National Center for PTSD, Boston Healthcare System, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Acierno', 'Affiliation': 'University of Texas Health Sciences Center Houston, Faillace Department of Psychiatry, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Messina', 'Affiliation': 'William S. Middleton VA Medical Center, USA.'}, {'ForeName': 'Travis A', 'Initials': 'TA', 'LastName': 'Cole', 'Affiliation': 'National Center for PTSD, Boston Healthcare System, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2021.100764']
755,33957767,Research on the Tufts Be Well at Work Program for Employees With Depression: 2005-2020.,"OBJECTIVE


Although depression is a prevalent and costly health problem exacting a large toll on work productivity, interventions targeting occupational functioning are rare. This article describes the development of the Tufts Be Well at Work intervention, a brief telephonic program designed to improve occupational functioning among employees with depression and reduce depression symptom severity. Results from 15 years of research are summarized evaluating the occupational, clinical, and economic impact of Be Well at Work.
METHODS


The design, methods, and results of all six Tufts Be Well at Work studies are reported. Studies included an initial workplace pilot study, two workplace randomized clinical trials (RCTs), one RCT in a health care system, and two pilot implementation studies conducted in a workplace and in an academic medical center. RCTs compared Tufts Be Well at Work to usual care.
RESULTS


Tufts Be Well at Work consistently and significantly improved occupational functioning, work productivity, and depression symptom severity. Employees randomly assigned to usual care experienced smaller gains. The program also delivered a positive return on investment.
CONCLUSIONS


Evidence suggests that Tufts Be Well at Work is an effective intervention for improving occupational and clinical functioning. Its relatively low cost and its impact on work productivity contribute to its positive economic impact.",2021,Employees randomly assigned to usual care experienced smaller gains.,"['Employees With Depression: 2005-2020', 'Tufts', 'employees with depression and reduce depression symptom severity']",[],"['occupational functioning, work productivity, and depression symptom severity', 'occupational functioning']","[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",[],"[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",2.0,0.0568345,Employees randomly assigned to usual care experienced smaller gains.,"[{'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Lerner', 'Affiliation': 'Program on Health, Work and Productivity, Institute for Clinical Research and Health Policy Studies (Lerner, Adler, Rogers), and Departments of Psychiatry and Medicine (Lerner, Adler), Tufts Medical Center, Boston; Department of Psychiatry, University of Massachusetts Medical School, Worcester (Shayani).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Adler', 'Affiliation': 'Program on Health, Work and Productivity, Institute for Clinical Research and Health Policy Studies (Lerner, Adler, Rogers), and Departments of Psychiatry and Medicine (Lerner, Adler), Tufts Medical Center, Boston; Department of Psychiatry, University of Massachusetts Medical School, Worcester (Shayani).'}, {'ForeName': 'Ariella', 'Initials': 'A', 'LastName': 'Shayani', 'Affiliation': 'Program on Health, Work and Productivity, Institute for Clinical Research and Health Policy Studies (Lerner, Adler, Rogers), and Departments of Psychiatry and Medicine (Lerner, Adler), Tufts Medical Center, Boston; Department of Psychiatry, University of Massachusetts Medical School, Worcester (Shayani).'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Rogers', 'Affiliation': 'Program on Health, Work and Productivity, Institute for Clinical Research and Health Policy Studies (Lerner, Adler, Rogers), and Departments of Psychiatry and Medicine (Lerner, Adler), Tufts Medical Center, Boston; Department of Psychiatry, University of Massachusetts Medical School, Worcester (Shayani).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.202000762']
756,33957195,"Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies.","BACKGROUND


Ruxolitinib (RUX) cream demonstrated potent anti-inflammatory and antipruritic efficacy in a phase 2 study in adults with atopic dermatitis (AD).
OBJECTIVE


To evaluate 8-week efficacy and safety in 2 phase 3 studies of RUX cream in patients with AD.
METHODS


Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (NCT03745638) and Study 2 (NCT03745651) enrolled patients aged ≥12 years with AD for ≥2 years, an Investigator's Global Assessment score of 2/3, and 3%-20% affected body surface area. Patients were randomized 2:2:1 to twice-daily 0.75% RUX cream, 1.5% RUX cream, or vehicle cream for 8 continuous weeks. The primary endpoint was Investigator's Global Assessment treatment success at week 8 (Investigator's Global Assessment score of 0/1 and ≥2-grade improvement from baseline).
RESULTS


In the Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 and 2, 631 and 618 patients were randomized (631/577 analyzed for efficacy). Significantly more patients achieved Investigator's Global Assessment treatment success with 0.75% RUX cream (50.0%/39.0%) and 1.5% RUX cream (53.8%/51.3%) versus vehicle (15.1%/7.6%; P < .0001) at week 8. Significant itch reductions versus vehicle were reported within 12 hours of first application of 1.5% RUX (P < .05). Application site reactions were infrequent (<1%) and lower with RUX versus vehicle; none were clinically significant.
LIMITATIONS


Longer-term safety data are not yet available.
CONCLUSIONS


RUX cream showed anti-inflammatory and prompt antipruritic effects with superior efficacy versus vehicle and was well tolerated.",2021,"CONCLUSIONS


RUX cream showed anti-inflammatory and prompt antipruritic effects with superior efficacy versus vehicle and was well tolerated.","['adults with atopic dermatitis (AD', 'patients with AD', 'Atopic Dermatitis', 'patients aged ≥12 years with AD for ≥2 years, an IGA score of 2/3, and 3% to 20% affected body surface area']","['twice-daily 0.75% RUX cream, 1.5% RUX cream, or vehicle cream', 'RUX cream', 'Ruxolitinib (RUX) cream', 'Ruxolitinib Cream']","['efficacy and safety', 'Efficacy and Safety', 'tolerated', 'Application site reactions', 'IGA treatment success (IGA-TS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0151505', 'cui_str': 'Application site reaction'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.174999,"CONCLUSIONS


RUX cream showed anti-inflammatory and prompt antipruritic effects with superior efficacy versus vehicle and was well tolerated.","[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'K. Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada. Electronic address: kapapp@probitymedical.com.'}, {'ForeName': 'Jacek C', 'Initials': 'JC', 'LastName': 'Szepietowski', 'Affiliation': 'Department of Dermatology, Venereology, and Allergology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Kircik', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Darryl', 'Initials': 'D', 'LastName': 'Toth', 'Affiliation': 'XLR8 Medical Research and Probity Medical Research, Windsor, Ontario, Canada.'}, {'ForeName': 'Lawrence F', 'Initials': 'LF', 'LastName': 'Eichenfield', 'Affiliation': 'Departments of Dermatology and Pediatrics, University of California San Diego, San Diego, California.'}, {'ForeName': 'Donald Y M', 'Initials': 'DYM', 'LastName': 'Leung', 'Affiliation': 'Division of Pediatric Allergy and Clinical Immunology, Department of Pediatrics, National Jewish Health, Denver, Colorado.'}, {'ForeName': 'Seth B', 'Initials': 'SB', 'LastName': 'Forman', 'Affiliation': 'ForCare Clinical Research, Tampa, Florida.'}, {'ForeName': 'May E', 'Initials': 'ME', 'LastName': 'Venturanza', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kuligowski', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2021.04.085']
757,33960618,Suppression of axillary odor and control of axillary bacterial flora by erythritol.,"BACKGROUND


Erythritol is a sugar alcohol with 4 carbon atoms that has approximately 75% of the sweetness of sucrose. It is a safe and widely used food component.
AIMS


We herein investigated the growth inhibitory effects on axillary odor-causing bacteria and axillary odor-reducing effects of erythritol.
METHODS


Growth tests in vitro were performed on Corynebacterium minutissimum, C. striatum, and Staphylococcus epidermidis. An axillary odor sensory test and axillary bacterial flora analysis were then conducted. A test product containing erythritol was applied to the axillae of 18 subjects.
RESULTS


Erythritol significantly inhibited the growth of tested bacteria. The results of the axillary odor sensory test showed that the median values for each odor intensity of Total axillary odor intensity, Animal, Milk-fat, Damp-dried dust cloth, and Sourness were significantly lower in the test product application group than in the placebo group (p = 0, 0.008, 0.025, 0.004, 0, 0.001, respectively). The axillary flora analysis revealed that the relative abundance of the most dominant bacteria was lower in the test product application group than in the placebo group. Furthermore, the diversity of the total bacterial flora was significantly higher in the test product application group (p = 0.048).
CONCLUSION


The present results suggest that erythritol inhibits the growth of the predominant bacteria in the axilla, increases the diversity of the bacterial flora, controls the bacterial flora of the skin to a healthy abundance ratio, and reduces axillary odor.",2022,"Furthermore, the diversity of the total bacterial flora was significantly higher in the test product application group (p = 0.048).
",['18 subjects'],['placebo'],"['relative abundance of the most dominant bacteria', 'median values for each odor intensity of Total axillary odor intensity, Animal, Milk-fat, Damp-dried dust cloth, and Sourness', 'growth of tested bacteria', 'diversity of the total bacterial flora']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C3256606', 'cui_str': 'milk fat, cow'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.068758,"Furthermore, the diversity of the total bacterial flora was significantly higher in the test product application group (p = 0.048).
","[{'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Research & Development Center, B Food Science Co., Ltd., Chita, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': 'Rohto Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kawai', 'Affiliation': 'Rohto Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Tochio', 'Affiliation': 'Research & Development Center, B Food Science Co., Ltd., Chita, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Rohto Pharmaceutical Co., Ltd., Osaka, Japan.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14201']
758,33969434,"A phase I study assessing the safety, tolerability, immunogenicity, and low-density lipoprotein cholesterol-lowering activity of immunotherapeutics targeting PCSK9.","PURPOSE


AT04A and AT06A are two AFFITOPE® peptide vaccine candidates being developed for the treatment of hypercholesterolemia by inducing proprotein convertase subtilisin/kexin type 9 (PCSK9)-specific antibodies. This study aimed to investigate safety, tolerability, antibody development, and reduction of low-density lipoprotein cholesterol (LDLc) following four subcutaneous immunizations.
METHODS


This phase I, single-blind, randomized, placebo-controlled study was conducted in a total of 72 healthy subjects with a mean fasting LDLc level at baseline of 117.1 mg/dL (range 77-196 mg/dL). Each cohort enrolled 24 subjects to receive three priming immunizations at weeks 0, 4, and 8 and to receive a single booster immunization at week 60 of either AT04A, AT06A, or placebo. In addition to safety (primary objective), the antigenic peptide- and PCSK9-specific antibody response and the impact on LDLc were evaluated over a period of 90 weeks.
RESULTS


The most common systemic treatment-related adverse events (AEs) reported were fatigue, headache, and myalgia in 75% of subjects in the AT06A group and 58% and 46% of subjects in the placebo and AT04A groups, respectively. Injection site reactions (ISR) representing 63% of all treatment-emergent adverse events (TEAEs), were transient and mostly of mild or moderate intensity and rarely severe (3%). Both active treatments triggered a robust, long-lasting antibody response towards the antigenic peptides used for immunization that optimally cross-reacted with the target epitope on PCSK9. In the AT04A group, a reduction in serum LDLc was observed with a mean peak reduction of 11.2% and 13.3% from baseline compared to placebo at week 20 and 70 respectively, and over the whole study period, the mean LDLc reduction for the AT04A group vs. placebo was -7.2% (95% CI [-10.4 to -3.9], P < 0.0001). In this group, PCSK9 target epitope titers above 50 were associated with clinically relevant LDLc reductions with an individual maximal decrease of 39%.
CONCLUSIONS


Although both AT04A and AT06 were safe and immunogenic, only AT04A demonstrated significant LDLc-lowering activity, justifying further development.
TRIAL REGISTRATION


EudraCT: 2015-001719-11. ClinicalTrials.gov Identifier: NCT02508896.",2021,"Injection site reactions (ISR) representing 63% of all treatment-emergent adverse events (TEAEs), were transient and mostly of mild or moderate intensity and rarely severe (3%).",['72 healthy subjects with a mean fasting LDLc level at baseline of 117.1\xa0mg/dL'],"['AT04A, AT06A, or placebo', 'placebo']","['mean peak reduction', 'mean LDLc reduction', 'serum LDLc', 'fatigue, headache, and myalgia', 'safety, tolerability, immunogenicity, and low-density lipoprotein cholesterol', 'antigenic peptide- and PCSK9-specific antibody response', 'safety, tolerability, antibody development, and reduction of low-density lipoprotein cholesterol (LDLc']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",72.0,0.244719,"Injection site reactions (ISR) representing 63% of all treatment-emergent adverse events (TEAEs), were transient and mostly of mild or moderate intensity and rarely severe (3%).","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Zeitlinger', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Reindl-Schwaighofer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Stoekenbroek', 'Affiliation': 'Department of Vascular Surgery, Academic Medical Center, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, Netherlands.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Lambert', 'Affiliation': 'Laboratoire Inserm, UMR 1188 DéTROI, Université de La Réunion, 2 Rue Maxime Rivière, 97490, Sainte Clotilde, France.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Berger-Sieczkowski', 'Affiliation': 'Department of Neurology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Heimo', 'Initials': 'H', 'LastName': 'Lagler', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Oesterreicher', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Wulkersdorfer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Lührs', 'Affiliation': 'AFFiRiS AG, Karl Farkas Gasse 22, 1030, Vienna, Austria.'}, {'ForeName': 'Gergana', 'Initials': 'G', 'LastName': 'Galabova', 'Affiliation': 'AFFiRiS AG, Karl Farkas Gasse 22, 1030, Vienna, Austria.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schwenke', 'Affiliation': 'SCO:SSiS, Karmeliterweg 42, 13465, Berlin, Germany.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Mader', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Medori', 'Affiliation': 'AFFiRiS AG, Karl Farkas Gasse 22, 1030, Vienna, Austria.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Landlinger', 'Affiliation': 'AFFiRiS AG, Karl Farkas Gasse 22, 1030, Vienna, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kutzelnigg', 'Affiliation': 'AFFiRiS AG, Karl Farkas Gasse 22, 1030, Vienna, Austria.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Staffler', 'Affiliation': 'AFFiRiS AG, Karl Farkas Gasse 22, 1030, Vienna, Austria. guenther.staffler@affiris.com.'}]",European journal of clinical pharmacology,['10.1007/s00228-021-03149-2']
759,33964979,Examining a stepped-care telehealth program for parents of young children with autism: a proof-of-concept trial.,"BACKGROUND


Intervention during the first years of life for children with autism spectrum disorder (ASD) may have the strongest impact on long-term brain development and functioning. Yet, barriers such as a shortage of trained professionals contribute to significant delays in service. The goal of this proof-of-concept study was to explore strategies that support timely and equitable deployment of ASD-specific interventions.
METHODS


This 15-week, randomized proof-of-concept study explored the acceptability of a digital parent mediated intervention online reciprocal imitation training (RIT; a naturalistic developmental behavioral intervention) and compared it to a treatment as usual (TAU) control on parent and child outcomes. Eligible children were between 18 and 60 months, met the cutoff for ASD on the Autism Diagnostic Observation Schedule-2nd Edition and demonstrate significant social imitation deficits. Primary outcomes include the acceptability of RIT (Scale of Treatment Perceptions) and the feasibility of the Online RIT digital intervention (online RIT attributes). Secondary outcomes included parent fidelity (RIT parent fidelity form) and parental self-efficacy (Early Intervention Parenting Self-Efficacy Scale). Exploratory outcome measures included child social communication (Social Communication Checklist), child imitation skills (Unstructured Imitation Assessment), and family quality of life (Beach Center Family Quality of Life Scale).
RESULTS


Twenty participants were randomized in a 1:1 fashion. The acceptability and feasibility of RIT and the Online RIT digital intervention were rated highly. Among the secondary outcomes, there were significant group differences in parent fidelity (p < .001) and self-efficacy (p = .029). On exploratory outcomes, there were group differences in child social communication (p = .048). There were no significant group differences in imitation ability (p = .05) or family quality of life (p = .22).
LIMITATIONS


There are several limitations with this study, including the small sample size as well as lack of data on enactment and website engagement. This study was not able to address questions related to which variables predict program engagement and treatment response, which will be critical for determining which families may benefit from such a stepped-care delivery model.
CONCLUSIONS


Overall, the Online RIT program delivered in a stepped-care format shows strong acceptability and holds promise as an innovative delivery model. Trial registration ClinicalTrials.gov, NCT04467073. Registered 10 July 2020- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04467073.",2021,"There were no significant group differences in imitation ability (p = .05) or family quality of life (p = .22).
","['Eligible children were between 18 and 60\xa0months, met the cutoff for ASD on the Autism Diagnostic Observation Schedule-2nd Edition and demonstrate significant social imitation deficits', 'Twenty participants', 'parents of young children with autism', 'children with autism spectrum disorder (ASD']","['stepped-care telehealth program', 'digital parent mediated intervention online reciprocal imitation training (RIT']","['self-efficacy', 'imitation ability', 'Parenting Self-Efficacy Scale', 'child social communication (Social Communication Checklist), child imitation skills (Unstructured Imitation Assessment), and family quality of life (Beach Center Family Quality of Life Scale', 'parent fidelity', 'acceptability and feasibility of RIT', 'parent fidelity (RIT parent fidelity form) and parental self-efficacy', 'acceptability of RIT (Scale of Treatment Perceptions) and the feasibility of the Online RIT digital intervention (online RIT attributes', 'child social communication', 'family quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0331781', 'cui_str': 'Beach'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}]",20.0,0.123012,"There were no significant group differences in imitation ability (p = .05) or family quality of life (p = .22).
","[{'ForeName': 'Allison L', 'Initials': 'AL', 'LastName': 'Wainer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, 1645 W. Jackson Blvd., Suite 603, Chicago, IL, 60612, USA. Allison_Wainer@rush.edu.'}, {'ForeName': 'Zachary E', 'Initials': 'ZE', 'LastName': 'Arnold', 'Affiliation': 'Department of Psychology, University of Alabama At Birmingham, 1300 University Blvd., Birmingham, AL, 35233, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Leonczyk', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, 1645 W. Jackson Blvd., Suite 603, Chicago, IL, 60612, USA.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Valluripalli Soorya', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, 1645 W. Jackson Blvd., Suite 603, Chicago, IL, 60612, USA.'}]",Molecular autism,['10.1186/s13229-021-00443-9']
760,33972949,LENZILUMAB EFFICACY AND SAFETY IN NEWLY HOSPITALIZED COVID-19 SUBJECTS: RESULTS FROM THE LIVE-AIR PHASE 3 RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL.,"BACKGROUND


Severe COVID-19 pneumonia results from a hyperinflammatory immune response (cytokine storm, CS), characterized by GM-CSF mediated activation and trafficking of myeloid cells, leading to elevation of downstream inflammatory chemokines (MCP-1, IL-8, IP-10), cytokines (IL-6, IL-1), and other markers of systemic inflammation (CRP, D-dimer, ferritin). CS leads to fever, hypotension, coagulopathy, respiratory failure, ARDS, and death. Lenzilumab is a novel Humaneered  ®  anti-human GM-CSF monoclonal antibody that directly binds GM-CSF and prevents signaling through its receptor. The LIVE-AIR Phase 3 randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of lenzilumab to assess the potential for lenzilumab to improve the likelihood of ventilator-free survival (referred to herein as survival without ventilation, SWOV), beyond standard supportive care, in hospitalized subjects with severe COVID-19.
METHODS


Subjects with COVID-19 (n=520), ≥18 years, and ≤94% oxygen saturation on room air and/or requiring supplemental oxygen, but not invasive mechanical ventilation, were randomized to receive lenzilumab (600 mg, n=261) or placebo (n=259) via three intravenous infusions administered 8 hours apart. Subjects were followed through Day 28 following treatment.
RESULTS


Baseline demographics were comparable between the two treatment groups: male, 64.7%; mean age, 60.5 years; mean BMI, 32.5 kg/m  2  ; mean CRP, 98.36 mg/L; CRP was <150 mg/L in 77.9% of subjects. The most common comorbidities were obesity (55.1%), diabetes (53.4%), chronic kidney disease (14.0%), and coronary artery disease (13.6%). Subjects received steroids (93.7%), remdesivir (72.4%), or both (69.1%). Lenzilumab improved the likelihood of SWOV by 54% in the mITT population (HR: 1.54; 95%CI: 1.02-2.31, p=0.041) and by 90% in the ITT population (HR: 1.90; 1.02-3.52, nominal p=0.043) compared to placebo. SWOV also relatively improved by 92% in subjects who received both corticosteroids and remdesivir (1.92; 1.20-3.07, nominal p=0.0067); by 2.96-fold in subjects with CRP<150 mg/L and age <85 years (2.96; 1.63-5.37, nominal p=0.0003); and by 88% in subjects hospitalized ≤2 days prior to randomization (1.88; 1.13-3.12, nominal p=0.015). Survival was improved by 2.17-fold in subjects with CRP<150 mg/L and age <85 years (2.17; 1.04-4.54, nominal p=0.040).
CONCLUSION


Lenzilumab significantly improved SWOV in hospitalized, hypoxic subjects with COVID-19 pneumonia over and above treatment with remdesivir and/or corticosteroids. Subjects with CRP<150 mg/L and age <85 years demonstrated an improvement in survival and had the greatest benefit from lenzilumab. NCT04351152.",2021,"Survival was improved by 2.17-fold in subjects with CRP<150 mg/L and age <85 years (2.17; 1.04-4.54, nominal p=0.040).
","['Subjects with COVID-19 (n=520), ≥18 years, and ≤94% oxygen saturation on room air and/or requiring supplemental oxygen, but not invasive mechanical ventilation', 'groups: male, 64.7%; mean age, 60.5 years; mean BMI, 32.5 kg/m  2  ; mean CRP, 98.36 mg/L', 'hospitalized subjects with severe COVID-19']","['placebo', 'lenzilumab', 'Lenzilumab']","['chronic kidney disease', 'likelihood of SWOV', 'survival', 'SWOV', 'Survival', 'fever, hypotension, coagulopathy, respiratory failure, ARDS, and death', 'coronary artery disease']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]",,0.269322,"Survival was improved by 2.17-fold in subjects with CRP<150 mg/L and age <85 years (2.17; 1.04-4.54, nominal p=0.040).
","[{'ForeName': 'Zelalem', 'Initials': 'Z', 'LastName': 'Temesgen', 'Affiliation': ''}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Burger', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Polk', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Libertin', 'Affiliation': ''}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Kelley', 'Affiliation': ''}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Orenstein', 'Affiliation': ''}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Durrant', 'Affiliation': ''}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Chappell', 'Affiliation': ''}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Ahmed', 'Affiliation': ''}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Chappell', 'Affiliation': ''}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Badley', 'Affiliation': ''}]",medRxiv : the preprint server for health sciences,['10.1101/2021.05.01.21256470']
761,33974131,"[Care of rheumatology patients during the lockdown in early 2020 : Telemedicine, delegation, patient satisfaction and vaccination behavior].","BACKGROUND


Telemedicine was implemented in outpatient care during the lockdown between March and May 2020. The aim of the study was to assess patients from a private practice and the university outpatient department with respect to patient satisfaction with telemedicine, COVID-19 worries and vaccination behavior and to compare the teleconsultation by a medical assistant for rheumatology (RFA) and a physician.
METHODS


Patients with rheumatoid arthritis, psoriatric arthropathy or spondylarthritis without treatment modifications since the previous presentation were offered a telemedical replacement appointment within the framework of this study in the case of appointment cancellation by the treating center. Participants were randomized to a telemedicine appointment by a physician or an RFA (RFA university only). The patient history was carried out by telephone and standardized using a questionnaire. The disease activity was determined using the modified clinical disease activity score (CDAI) and the BASDAI. Subsequently, all patients received a pseudonymized evaluation questionnaire.
RESULTS


In total 112/116 (96%) patients participated. Of these 88/112 (79%) returned the questionnaire. The RFAs conducted 19/112 (17%) of the telephone calls. The treatment was modified in 19/112 (17%) patients. Concerns about contracting COVID-19 correlated with high disease activity (p = 0.031) including the presence of painful joints (p = 0.001) and high pain levels (VAS ≥7, p = 0.009). These patients would have also cancelled their appointment themselves (p = 0.015). Patient satisfaction with the consultation was good (mean 4.3/5.0 modified FAPI) independent of the institution, the duration of the consultation and the consultation partner. Patients with a high pain intensity were the least satisfied (p = 0.036). Only 42/100 (38.2%) of the patients had been vaccinated against pneumococci and 59/100 (53.6%) against influenza.
CONCLUSION


Telemedical care within the framework of a telephone consultation is well-suited for selected patients. With respect to patient satisfaction the delegation of a telemedical consultation to an RFA is possible. There is a need for improvement with respect to the vaccination behavior.",2022,"Concerns about contracting COVID-19 correlated with high disease activity (p = 0.031) including the presence of painful joints (p = 0.001) and high pain levels (VAS ≥7, p = 0.009).","['rheumatology patients during the lockdown in early 2020 ', 'Patients with rheumatoid arthritis, psoriatric arthropathy or spondylarthritis without treatment modifications since the previous presentation were offered a telemedical replacement appointment within the framework of this study in the case of appointment cancellation by the treating center', 'patients from a private practice and the university outpatient department with respect to patient satisfaction with telemedicine, COVID-19 worries and vaccination behavior and to compare the teleconsultation by a\xa0medical assistant for rheumatology (RFA) and a physician']",['telemedicine appointment by a\xa0physician or an RFA (RFA university only'],"['high pain levels', 'modified clinical disease activity score (CDAI) and the BASDAI', 'presence of painful joints', 'disease activity']","[{'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C1299575', 'cui_str': 'Treatment modification'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282675', 'cui_str': 'Teleconsultation'}, {'cui': 'C0334914', 'cui_str': 'Medical assistant'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0484859,"Concerns about contracting COVID-19 correlated with high disease activity (p = 0.031) including the presence of painful joints (p = 0.001) and high pain levels (VAS ≥7, p = 0.009).","[{'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Thiele', 'Affiliation': 'Klinik für Rheumatologie und Immunologie, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Beider', 'Affiliation': 'Klinik für Rheumatologie und Immunologie, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kühl', 'Affiliation': 'Klinik für Rheumatologie und Immunologie, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Mielke', 'Affiliation': 'Klinik für Rheumatologie und Immunologie, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Holz', 'Affiliation': 'Rheumatologische Facharztpraxis, Hildesheim, Deutschland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hirsch', 'Affiliation': 'Klinik für Rheumatologie und Immunologie, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Witte', 'Affiliation': 'Klinik für Rheumatologie und Immunologie, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Hoeper', 'Affiliation': 'Klinik für Rheumatologie und Immunologie, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cossmann', 'Affiliation': 'Klinik für Rheumatologie und Immunologie, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Happle', 'Affiliation': 'Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie, Medizinische Hochschule Hannover, Hannover, Deutschland.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Jablonka', 'Affiliation': 'Klinik für Rheumatologie und Immunologie, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ernst', 'Affiliation': 'Klinik für Rheumatologie und Immunologie, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland. Ernst.Diana@mh-hannover.de.'}]",Zeitschrift fur Rheumatologie,['10.1007/s00393-021-01005-3']
762,33971731,Helping People Denied Disability Benefits for a Mental Health Impairment: The Supported Employment Demonstration.,"Social Security Administration demonstration projects that are intended to help people receiving disability benefits have increased employment but not the number of exits from disability programs. The Supported Employment Demonstration (SED) is a randomized controlled trial (RCT) of services for individuals with mental health problems before they enter disability programs. The SED aims to provide health, employment, and other support services that help them become self-sufficient and avoid entering disability programs. The target population is people who have been denied Social Security disability benefits for a presumed psychiatric impairment. Thirty community-based programs across the United States serve as treatment sites; inclusion in the SED was based on the existence of high-fidelity employment programs that use the individual placement and support model, the ability to implement team-based care, and the willingness to participate in a three-armed RCT. In the SED trial, one-third of 2,960 participants receive services as usual, one-third receive services from a multidisciplinary team that includes integrated supported employment, and one-third receive services from a similar team that also includes a nurse care coordinator for medication management support and medical care. The goals of the study are to help people find employment, attain better health, and delay or avoid disability program entry. This article introduces the SED.",2021,Social Security Administration demonstration projects that are intended to help people receiving disability benefits have increased employment but not the number of exits from disability programs.,"['Mental Health Impairment', '2,960 participants receive services as usual, one-third receive services from a', 'individuals with mental health problems before they enter disability programs']","['multidisciplinary team that includes integrated supported employment, and one-third receive services from a similar team that also includes a nurse care coordinator for medication management support and medical care']",[],"[{'cui': 'C0556284', 'cui_str': 'Mental health impairment'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C4708569', 'cui_str': 'Care coordinator'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]",[],,0.0333594,Social Security Administration demonstration projects that are intended to help people receiving disability benefits have increased employment but not the number of exits from disability programs.,"[{'ForeName': 'Jarnee', 'Initials': 'J', 'LastName': 'Riley', 'Affiliation': 'Department of Social Policy and Economics Research, Westat Corporation, Rockville, Maryland.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Drake', 'Affiliation': 'Department of Social Policy and Economics Research, Westat Corporation, Rockville, Maryland.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Frey', 'Affiliation': 'Department of Social Policy and Economics Research, Westat Corporation, Rockville, Maryland.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Goldman', 'Affiliation': 'Department of Social Policy and Economics Research, Westat Corporation, Rockville, Maryland.'}, {'ForeName': 'Deborah R', 'Initials': 'DR', 'LastName': 'Becker', 'Affiliation': 'Department of Social Policy and Economics Research, Westat Corporation, Rockville, Maryland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Salkever', 'Affiliation': 'Department of Social Policy and Economics Research, Westat Corporation, Rockville, Maryland.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Marrow', 'Affiliation': 'Department of Social Policy and Economics Research, Westat Corporation, Rockville, Maryland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Borger', 'Affiliation': 'Department of Social Policy and Economics Research, Westat Corporation, Rockville, Maryland.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Department of Social Policy and Economics Research, Westat Corporation, Rockville, Maryland.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Bond', 'Affiliation': 'Department of Social Policy and Economics Research, Westat Corporation, Rockville, Maryland.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Karakus', 'Affiliation': 'Department of Social Policy and Economics Research, Westat Corporation, Rockville, Maryland.'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.202000671']
763,33972448,Alcohol narrows physical distance between strangers.,"Pandemic management is likely to represent a global reality for years to come, but the roadmap for how to approach pandemic restrictions is as yet unclear. Of the restrictions enacted during COVID-19, among the more controversial surround alcohol. Like many infectious diseases, the principal mode of transmission for COVID-19 is direct respiration of droplets emitted during close social contact, and health officials warn that alcohol consumption may lead to decreased adherence to physical distancing guidelines. Governing bodies have acted to close bars before restaurants and have also specifically restricted alcohol sales, while at the same time those in the nightlife industry have labeled such actions unfounded and discriminatory. Complicating such debates is the lack of evidence on alcohol's effects on physical distance. In the current study we employed a randomized alcohol-administration design paired with computer-vision measures, analyzing over 20,000 proximity readings derived from video to examine the effect of alcohol consumption on physical distance during social interaction. Results indicated that alcohol caused individuals to draw significantly closer to an unfamiliar interaction partner during social exchange, reducing physical proximity at a rate with potentially important implications for public health. In contrast, alcohol had no effect on physical distance with a familiar interaction partner. Findings suggest that alcohol might act to overcome a natural caution people feel towards strangers and thus promote virus transmission between previously unconnected social groups.",2021,"Results indicated that alcohol caused individuals to draw significantly closer to an unfamiliar interaction partner during social exchange, reducing physical proximity at a rate with potentially important implications for public health.",[],['alcohol consumption'],['physical distance'],[],"[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.00489606,"Results indicated that alcohol caused individuals to draw significantly closer to an unfamiliar interaction partner during social exchange, reducing physical proximity at a rate with potentially important implications for public health.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gurrieri', 'Affiliation': 'Department of Psychology, University of Illinois at Urbana-Champaign, Champaign, IL 61820.'}, {'ForeName': 'Catharine E', 'Initials': 'CE', 'LastName': 'Fairbairn', 'Affiliation': 'Department of Psychology, University of Illinois at Urbana-Champaign, Champaign, IL 61820; cfairbai@illinois.edu.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Sayette', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA 15260.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Bosch', 'Affiliation': 'School of Information Sciences, University of Illinois at Urbana-Champaign, Champaign, IL 61820.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2101937118']
764,33973141,"The Effects of Exergame on Postural Control in Individuals with Ataxia: a Rater-Blinded, Randomized Controlled, Cross-over Study.","Exergame trainings might have therapeutic value in ataxic patients. The aim of this study was to investigate the effect of exergame training with an exercise program on postural control by comparing it with traditional balance and coordination exercise program. Nineteen patients were randomly allocated to two groups. In the first group, exergame training and an exercise program (EEP) were applied together for the first 8 weeks; after 10 weeks washout, a conventional exercise program (CEP) was applied for the second 8 weeks. In the second group, the CEP was applied first followed by the EEP. Outcome measures were Limits of Stability test (LoS), International Classification Ataxia Ratio Scale (ICARS), Berg Balance Scale (BBS), and Timed-Up and Go test with a cognitive task (TUG-C), Reactive postural control and sensory orientation subscales of the Mini-BESTest. Seventeen patients (mean age ± SD, 32.53 ± 11.07 years) completed the study. ICARS, BBS scores improved only after EEP (p < 0.05). While there was no change in the RT and MVL parameters of the LoS test after EEP, the MXE, EPE, and DCL parameters improved significantly (p < 0.05). The MXE and MVL parameters of LoS improved after CEP (p < 0.05). There were no significant improvements in the Mini-BESTest's reactive postural control and sensory orientation subscale scores after both EEP and CEP (p > 0.05). The results of the present study demonstrated that exergame training can be used as a complementary training option in physiotherapy to improve postural control in patients with ataxia. ClinicalTrial.gov Identifier: NCT03607058.",2022,There were no significant improvements in the Mini-BESTest's reactive postural control and sensory orientation subscale scores after both EEP and CEP (p > 0.05).,"['Nineteen patients', 'ataxic patients', 'Individuals with Ataxia', 'Seventeen patients (mean age\u2009±\u2009SD, 32.53\u2009±\u200911.07\xa0years) completed the study', 'patients with ataxia']","['exergame training with an exercise program', 'Exergame', 'exergame training and an exercise program (EEP', 'conventional exercise program (CEP', 'traditional balance and coordination exercise program', 'CEP']","['MXE and MVL parameters of LoS', 'ICARS, BBS scores', 'Limits of Stability test (LoS), International Classification Ataxia Ratio Scale (ICARS), Berg Balance Scale (BBS), and Timed-Up and Go test with a cognitive task (TUG-C), Reactive postural control and sensory orientation subscales of the Mini-BESTest', 'RT and MVL parameters', 'MXE, EPE, and DCL parameters', ""Mini-BESTest's reactive postural control and sensory orientation subscale scores""]","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0234366', 'cui_str': 'Ataxic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0203990', 'cui_str': 'Coordination exercise'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",19.0,0.0106289,There were no significant improvements in the Mini-BESTest's reactive postural control and sensory orientation subscale scores after both EEP and CEP (p > 0.05).,"[{'ForeName': 'Ender', 'Initials': 'E', 'LastName': 'Ayvat', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, 06100, Ankara, Turkey. ender.ayvat@gmail.com.'}, {'ForeName': 'Özge', 'Initials': 'Ö', 'LastName': 'Onursal Kılınç', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, 06100, Ankara, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Ayvat', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, 06100, Ankara, Turkey.'}, {'ForeName': 'Cevher', 'Initials': 'C', 'LastName': 'Savcun Demirci', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Balıkesir University, Balıkesir, Turkey.'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Aksu Yıldırım', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, 06100, Ankara, Turkey.'}, {'ForeName': 'Oğuzhan', 'Initials': 'O', 'LastName': 'Kurşun', 'Affiliation': 'Neurology Clinic, Ministry of Health Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Kılınç', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, 06100, Ankara, Turkey.'}]","Cerebellum (London, England)",['10.1007/s12311-021-01277-0']
765,33971654,Effects of Short- and Long-Term Aerobic-Strength Training and Determinants of Walking Speed in the Elderly.,"BACKGROUND/AIMS


Walking speed (WS) is an objective measure of physical capacity and a modifiable risk factor of morbidity and mortality in the elderly. In this study, we (i) determined effects of 3-month supervised aerobic-strength training on WS, muscle strength, and habitual physical activity; (ii) evaluated capacity of long-term (21 months) training to sustain higher WS; and (iii) identified determinants of WS in the elderly.
METHODS


Volunteers (F 48/M 14, 68.4 ± 7.1 years) completed either 3-month aerobic-strength (3 × 1 h/week, n = 48) or stretching (active control, n = 14) intervention (study A). Thirty-one individuals (F 24/M 7) from study A continued in supervised aerobic-strength training (2 × 1 h/week, 21 months) and 6 (F 5/M 1) became nonexercising controls.
RESULTS


Three-month aerobic-strength training increased preferred and maximal WS (10-m walk test, p < 0.01), muscle strength (p < 0.01) and torque (p < 0.01) at knee extension, and 24-h habitual physical activity (p < 0.001), while stretching increased only preferred WS (p < 0.03). Effect of training on maximal WS was most prominent in individuals with baseline WS between 1.85 and 2.30 m·s-1. Maximal WS measured before intervention correlated negatively with age (r = -0.339, p = 0.007), but this correlation was weakened by the intervention (r = -0.238, p = 0.06). WS progressively increased within the first 9 months of aerobic-strength training (p < 0.001) and remained elevated during 21-month intervention (p < 0.01). Cerebellar gray matter volume (MRI) was positively associated with maximal (r = 0.54; p < 0.0001) but not preferred WS and explained >26% of its variability, while age had only minor effect.
CONCLUSIONS


Supervised aerobic-strength training increased WS, strength, and dynamics of voluntary knee extension as well as habitual physical activity in older individuals. Favorable changes in WS were sustainable over the 21-month period by a lower dose of aerobic-strength training. Training effects on WS were not limited by age, and cerebellar cortex volume was the key determinant of WS.",2022,"RESULTS


Three-month aerobic-strength training increased preferred and maximal WS (10-m walk test, p < 0.01), muscle strength (p < 0.01) and torque (p < 0.01) at knee extension, and 24-h habitual physical activity (p < 0.001), while stretching increased only preferred WS (p < 0.03).","['individuals with baseline WS between 1.85 and 2.30', 'older individuals', 'Elderly', 'Volunteers (F 48/M 14, 68.4 ± 7.1 years) completed either', 'Thirty-one individuals (F 24/M 7) from study A continued in']","['stretching (active control, n = 14) intervention', 'Short- and Long-Term Aerobic-Strength Training', 'Supervised aerobic-strength training', '3-month aerobic-strength', 'supervised aerobic-strength training']","['24-h habitual physical activity', 'Cerebellar gray matter volume (MRI', 'torque', 'Maximal WS', 'habitual physical activity', 'muscle strength', 'WS, muscle strength, and habitual physical activity', 'maximal WS', 'WS, strength, and dynamics of voluntary knee extension']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3850014', 'cui_str': 'Cerebellar Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",,0.00462101,"RESULTS


Three-month aerobic-strength training increased preferred and maximal WS (10-m walk test, p < 0.01), muscle strength (p < 0.01) and torque (p < 0.01) at knee extension, and 24-h habitual physical activity (p < 0.001), while stretching increased only preferred WS (p < 0.03).","[{'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Slobodová', 'Affiliation': 'Biomedical Research Center, Institute of Experimental Endocrinology, Slovak Academy of Sciences, University Science, Park for Biomedicine, Bratislava, Slovakia.'}, {'ForeName': 'Ľudmila', 'Initials': 'Ľ', 'LastName': 'Oreská', 'Affiliation': 'Faculty of Physical Education and Sports, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schön', 'Affiliation': 'Biomedical Research Center, Institute of Experimental Endocrinology, Slovak Academy of Sciences, University Science, Park for Biomedicine, Bratislava, Slovakia.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Krumpolec', 'Affiliation': 'Biomedical Research Center, Institute of Experimental Endocrinology, Slovak Academy of Sciences, University Science, Park for Biomedicine, Bratislava, Slovakia.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Tirpáková', 'Affiliation': 'Institute of Sports Medicine, Faculty of Medicine, Slovak Medical University, Bratislava, Slovakia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jurina', 'Affiliation': 'Biomedical Research Center, Institute of Experimental Endocrinology, Slovak Academy of Sciences, University Science, Park for Biomedicine, Bratislava, Slovakia.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Laurovič', 'Affiliation': 'Biomedical Research Center, Institute of Experimental Endocrinology, Slovak Academy of Sciences, University Science, Park for Biomedicine, Bratislava, Slovakia.'}, {'ForeName': 'Matej', 'Initials': 'M', 'LastName': 'Vajda', 'Affiliation': 'Faculty of Physical Education and Sports, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Nemec', 'Affiliation': 'Biomedical Research Center, Institute of Experimental Endocrinology, Slovak Academy of Sciences, University Science, Park for Biomedicine, Bratislava, Slovakia.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hečková', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Šoóšová', 'Affiliation': 'National Institute of Cardiovascular Diseases, Bratislava, Slovakia.'}, {'ForeName': 'Ján', 'Initials': 'J', 'LastName': 'Cvečka', 'Affiliation': 'Faculty of Physical Education and Sports, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'Dušan', 'Initials': 'D', 'LastName': 'Hamar', 'Affiliation': 'Faculty of Physical Education and Sports, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Turčáni', 'Affiliation': '1st Department of Neurology, Faculty of Medicine, Comenius University & University Hospital Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Chia-Liang', 'Initials': 'CL', 'LastName': 'Tsai', 'Affiliation': 'Institute of Physical Education, Health and Leisure Studies, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Bogner', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Sedliak', 'Affiliation': 'Faculty of Physical Education and Sports, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Krššák', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Biomedical Research Center, Institute of Experimental Endocrinology, Slovak Academy of Sciences, University Science, Park for Biomedicine, Bratislava, Slovakia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ukropcová', 'Affiliation': 'Biomedical Research Center, Institute of Experimental Endocrinology, Slovak Academy of Sciences, University Science, Park for Biomedicine, Bratislava, Slovakia.'}]",Gerontology,['10.1159/000515325']
766,33978907,Impact of antithrombin III and enoxaparin dosage adjustment on prophylactic anti-Xa concentrations in trauma patients at high risk for venous thromboembolism: a randomized pilot trial.,"The impact of antithrombin III activity (AT-III) on prophylactic enoxaparin anti-factor Xa concentration (anti-Xa) is unknown in high-risk trauma patients. So too is the optimal anti-Xa-adjusted enoxaparin dosage. This prospective, randomized, pilot study sought to explore the association between AT-III and anti-Xa goal attainment and to preliminarily evaluate two enoxaparin dosage adjustment strategies in patients with subprophylactic anti-Xa. Adult trauma patients with Risk Assessment Profile (RAP) ≥ 5 prescribed enoxaparin 30 mg subcutaneously every 12 h were eligible. AT-III and anti-Xa were drawn 8 h after the third enoxaparin dose and compared between patients with anti-Xa ≥ 0.1 IU/mL (goal; control group) or anti-Xa < 0.1 IU/mL (subprophylactic; intervention group). The primary outcome was difference in baseline AT-III. Subsequently, intervention group patients underwent 1:1 randomization to either enoxaparin 40 mg every 12 h (up to 50 mg every 12 h if repeat anti-Xa < 0.1 IU/mL) (enox12) or enoxaparin 30 mg every 8 h (enox8) with repeat anti-Xa assessments. The proportion of patients achieving goal anti-Xa after dosage adjustment were compared. A total of 103 patients were included. Anti-Xa was subprophylactic in 50.5%. Baseline AT-III (median [IQR]) was 87% [80-98%] in control patients versus 82% [71-96%] in intervention patients (p = 0.092). Goal trough anti-Xa was achieved on first assessment in 38.1% enox12 versus 50% enox8 patients (p = 0.67), 84.6% versus 53.3% on second assessment (p = 0.11), and 100% vs. 54.5% on third trough assessment (p = 0.045). AT-III activity did not differ between high-risk trauma patients with goal and subprophylactic enoxaparin anti-Xa concentrations, although future investigation is warranted. Enoxaparin dose adjustment rather than frequency adjustment may be associated with a higher proportion of patients achieving goal anti-Xa over time.",2021,"AT-III activity did not differ between high-risk trauma patients with goal and subprophylactic enoxaparin anti-Xa concentrations, although future investigation is warranted.","['A total of 103 patients were included', 'high-risk trauma patients', 'patients with subprophylactic anti-Xa. Adult trauma patients with Risk Assessment Profile (RAP)\u2009≥', 'trauma patients at high risk for venous thromboembolism']","['anti-Xa\u2009<\u20090.1\xa0IU/mL (subprophylactic; intervention', 'enoxaparin anti-factor Xa concentration (anti-Xa', 'enoxaparin 40\xa0mg every 12\xa0h (up to 50\xa0mg every 12\xa0h if repeat anti-Xa\u2009<\u20090.1\xa0IU/mL) (enox12) or enoxaparin 30\xa0mg every 8\xa0h (enox8) with repeat anti-Xa assessments', 'enoxaparin', 'antithrombin III and enoxaparin', 'Enoxaparin', 'enoxaparin 30\xa0mg subcutaneously', 'antithrombin III activity (AT-III']","['prophylactic anti-Xa concentrations', 'proportion of patients achieving goal anti-Xa', 'baseline AT-III', 'Goal trough anti-Xa']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0443793', 'cui_str': 'Anti factor Xa'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]","[{'cui': 'C0443793', 'cui_str': 'Anti factor Xa'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0200416', 'cui_str': 'Antithrombin III assay'}, {'cui': 'C0724532', 'cui_str': 'Human antithrombin III'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0443793', 'cui_str': 'Anti factor Xa'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272277', 'cui_str': 'Goal achieved'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0724532', 'cui_str': 'Human antithrombin III'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0444506', 'cui_str': 'Trough'}]",103.0,0.0841197,"AT-III activity did not differ between high-risk trauma patients with goal and subprophylactic enoxaparin anti-Xa concentrations, although future investigation is warranted.","[{'ForeName': 'Molly Elizabeth', 'Initials': 'ME', 'LastName': 'Droege', 'Affiliation': 'UC Health - University of Cincinnati Medical Center, 234 Goodman Street, Mail Location 0740, Cincinnati, OH, USA. Molly.Droege@UCHealth.com.'}, {'ForeName': 'Christopher Allen', 'Initials': 'CA', 'LastName': 'Droege', 'Affiliation': 'UC Health - University of Cincinnati Medical Center, 234 Goodman Street, Mail Location 0740, Cincinnati, OH, USA.'}, {'ForeName': 'Carolyn Dosen', 'Initials': 'CD', 'LastName': 'Philpott', 'Affiliation': 'UC Health - University of Cincinnati Medical Center, 234 Goodman Street, Mail Location 0740, Cincinnati, OH, USA.'}, {'ForeName': 'Megan Leslie', 'Initials': 'ML', 'LastName': 'Webb', 'Affiliation': 'UC Health - University of Cincinnati Medical Center, 234 Goodman Street, Mail Location 0740, Cincinnati, OH, USA.'}, {'ForeName': 'Neil Edward', 'Initials': 'NE', 'LastName': 'Ernst', 'Affiliation': 'UC Health - University of Cincinnati Medical Center, 234 Goodman Street, Mail Location 0740, Cincinnati, OH, USA.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Athota', 'Affiliation': 'Department of Surgery, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Mail Location 0558, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Wakefield', 'Affiliation': 'Department of Surgery, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Mail Location 0558, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Joseph Richard', 'Initials': 'JR', 'LastName': 'Dowd', 'Affiliation': 'Department of Surgery, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Mail Location 0558, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Gomaa', 'Affiliation': 'Department of Surgery, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Mail Location 0558, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Bryce H R', 'Initials': 'BHR', 'LastName': 'Robinson', 'Affiliation': 'Department of Surgery, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Mail Location 0558, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Hanseman', 'Affiliation': 'Department of Surgery, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Mail Location 0558, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Elterman', 'Affiliation': 'Department of Surgery, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Mail Location 0558, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Eric William', 'Initials': 'EW', 'LastName': 'Mueller', 'Affiliation': 'UC Health - University of Cincinnati Medical Center, 234 Goodman Street, Mail Location 0740, Cincinnati, OH, USA.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-021-02478-4']
767,33976420,Randomized prospective evaluation of genome sequencing versus standard-of-care as a first molecular diagnostic test.,"PURPOSE


To evaluate the diagnostic yield and clinical relevance of clinical genome sequencing (cGS) as a first genetic test for patients with suspected monogenic disorders.
METHODS


We conducted a prospective randomized study with pediatric and adult patients recruited from genetics clinics at Massachusetts General Hospital who were undergoing planned genetic testing. Participants were randomized into two groups: standard-of-care genetic testing (SOC) only or SOC and cGS.
RESULTS


Two hundred four participants were enrolled, 202 were randomized to one of the intervention arms, and 99 received cGS. In total, cGS returned 16 molecular diagnoses that fully or partially explained the indication for testing in 16 individuals (16.2% of the cohort, 95% confidence interval [CI] 8.9-23.4%), which was not significantly different from SOC (18.2%, 95% CI 10.6-25.8%, P = 0.71). An additional eight molecular diagnoses reported by cGS had uncertain relevance to the participant's phenotype. Nevertheless, referring providers considered 20/24 total cGS molecular diagnoses (83%) to be explanatory for clinical features or worthy of additional workup.
CONCLUSION


cGS is technically suitable as a first genetic test. In our cohort, diagnostic yield was not significantly different from SOC. Further studies addressing other variant types and implementation challenges are needed to support feasibility and utility of broad-scale cGS adoption.",2021,"To evaluate the diagnostic yield and clinical relevance of clinical genome sequencing (cGS) as a first genetic test for patients with suspected monogenic disorders.
","['patients with suspected monogenic disorders', 'Two hundred four participants were enrolled, 202', 'pediatric and adult patients recruited from genetics clinics at Massachusetts General Hospital who were undergoing planned genetic testing']","['standard-of-care genetic testing (SOC) only or SOC and cGS', 'cGS', 'genome sequencing versus standard-of-care']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3840001', 'cui_str': 'Genetics clinic'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}]",[],204.0,0.221924,"To evaluate the diagnostic yield and clinical relevance of clinical genome sequencing (cGS) as a first genetic test for patients with suspected monogenic disorders.
","[{'ForeName': 'Deanna G', 'Initials': 'DG', 'LastName': 'Brockman', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA. Deanna.brockman@mgh.harvard.edu.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Austin-Tse', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Renée C', 'Initials': 'RC', 'LastName': 'Pelletier', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Harley', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Patterson', 'Affiliation': 'Broad Institute of Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Head', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Courtney Elizabeth', 'Initials': 'CE', 'LastName': 'Leonard', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': ""O'Brien"", 'Affiliation': 'Laboratory for Molecular Medicine, Partners Personalized Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Mahanta', 'Affiliation': 'Laboratory for Molecular Medicine, Partners Personalized Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Lebo', 'Affiliation': 'Laboratory for Molecular Medicine, Partners Personalized Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Christine Y', 'Initials': 'CY', 'LastName': 'Lu', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Natarajan', 'Affiliation': 'Broad Institute of Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Amit V', 'Initials': 'AV', 'LastName': 'Khera', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Krishna G', 'Initials': 'KG', 'LastName': 'Aragam', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Sekar', 'Initials': 'S', 'LastName': 'Kathiresan', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Rehm', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Miriam S', 'Initials': 'MS', 'LastName': 'Udler', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-021-01193-y']
768,33991085,Fatigue Perpetuating Factors as Mediators of Change in a Cognitive Behavioral Intervention for Targeted Therapy-Related Fatigue in Chronic Myeloid Leukemia: A Pilot Study.,"BACKGROUND


Cognitive behavioral therapy for targeted-therapy related fatigue (CBT-TTF) has demonstrated preliminary efficacy in reducing fatigue in patients treated with tyrosine kinase inhibitors (TKIs) for chronic myeloid leukemia (CML).
PURPOSE


The aim of the current analyses was to explore whether fatigue perpetuating factors (disturbed sleep/wake cycle, dysregulated activity patterns, maladaptive cognitions about fatigue and cancer, insufficient processing of cancer and treatment, inadequate social support and interactions, heightened fear of cancer progression) changed over time in patients receiving CBT-TTF, and whether the effect of CBT-TTF on fatigue was mediated by these factors.
METHODS


Secondary data analyses were conducted from a pilot randomized controlled trial. Patients with CML treated with a TKI who reported moderate to severe fatigue were randomized 2:1 to CBT-TTF delivered via FaceTime for iPad or a waitlist control condition (WLC). Self-report measures of fatigue and fatigue perpetuating factors were obtained before randomization and post-intervention (i.e., approximately 18 weeks later). Mixed model and mediation analyses using bootstrap methods were used.
RESULTS


A total of 36 participants (CBT-TTF n = 22, WLC n = 14) who had baseline and 18-week follow-up data and attended >5 sessions for CBT-TTF were included. Participants randomized to CBT-TTF reported improvements in activity (mental, physical, social, p's ≤ .023) and cognitions (helplessness, catastrophizing, focusing on symptoms, self-efficacy, p's ≤ .003) compared to WLC. Mental activity, social activity, self-efficacy, helplessness, and focusing on symptoms, as well as sleep and insufficient processing (avoidance) mediated the relationship between treatment group and fatigue.
CONCLUSIONS


CBT-TTF appears to improve TKI-related fatigue in CML patients through changes in behavior (sleep, activity patterns) and cognitions about fatigue and cancer. A larger randomized controlled trial is warranted to confirm these findings.",2022,"Participants randomized to CBT-TTF reported improvements in activity (mental, physical, social, p's ≤ .023) and cognitions (helplessness, catastrophizing, focusing on symptoms, self-efficacy, p's ≤ .003) compared to WLC.","['patients treated with tyrosine kinase inhibitors (TKIs) for chronic myeloid leukemia (CML', 'Patients with CML treated with a TKI who reported moderate to severe fatigue', '36 participants (CBT-TTF n = 22, WLC n = 14) who had baseline and 18-week follow-up data and attended >5 sessions for CBT-TTF were included', 'Chronic Myeloid Leukemia']","['Cognitive Behavioral Intervention', 'CBT-TTF', 'CBT-TTF delivered via FaceTime for iPad or a waitlist control condition (WLC', 'Cognitive behavioral therapy']","['behavior (sleep, activity patterns) and cognitions about fatigue and cancer', 'fatigue perpetuating factors (disturbed sleep/wake cycle, dysregulated activity patterns, maladaptive cognitions about fatigue and cancer, insufficient processing of cancer and treatment, inadequate social support and interactions, heightened fear of cancer progression', ""activity (mental, physical, social, p's ≤ .023) and cognitions (helplessness, catastrophizing, focusing on symptoms, self-efficacy"", 'Mental activity, social activity, self-efficacy, helplessness, and focusing on symptoms, as well as sleep and insufficient processing (avoidance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2364105', 'cui_str': 'Inadequate social support'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018897', 'cui_str': 'Learned Helplessness'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",36.0,0.139943,"Participants randomized to CBT-TTF reported improvements in activity (mental, physical, social, p's ≤ .023) and cognitions (helplessness, catastrophizing, focusing on symptoms, self-efficacy, p's ≤ .003) compared to WLC.","[{'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Hyland', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Nelson', 'Affiliation': 'Department of Psychiatry, Harvard Medical School/Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Eisel', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Aasha I', 'Initials': 'AI', 'LastName': 'Hoogland', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ibarz-Pinilla', 'Affiliation': 'Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Sweet', 'Affiliation': 'Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Jacobsen', 'Affiliation': 'Healthcare Delivery Research Program, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Knoop', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Heather S L', 'Initials': 'HSL', 'LastName': 'Jim', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaab035']
769,33991326,"Pharmacokinetics and Comparative Bioavailability of Apomorphine Sublingual Film and Subcutaneous Apomorphine Formulations in Patients with Parkinson's Disease and ""OFF"" Episodes: Results of a Randomized, Three-Way Crossover, Open-Label Study.","INTRODUCTION


In a pivotal study, apomorphine sublingual film (APL; KYNMOBI ® ) was an effective and generally well-tolerated on-demand treatment of ""OFF"" episodes in patients with Parkinson's disease (PD), approved across the dose range of 10-30 mg. Pharmacokinetics and comparative bioavailability of APL and two subcutaneous (SC) apomorphine formulations (SC-APO [APOKYN ® ] and SC-APO-GO [APO-go ®  PEN]) were evaluated in a randomized, three-way crossover, open-label study (NCT03292016).
METHODS


Patients with PD and ""OFF"" episodes received an open-label randomized sequence of single doses of SC-APO and SC-APO-GO at the currently prescribed dose (2/3/4/5 mg) and APL doses with similar plasma exposure (15/20/25/30 mg) with ≥ 1-day washout between formulations. Plasma pharmacokinetics of apomorphine and apomorphine sulfate (major inactive metabolite) were measured 0-6 h postdose.
RESULTS


Median time to maximum plasma concentration (t max ) of apomorphine was 0.63-0.75 h for APL and 0.25-0.38 h for SC-APO and SC-APO-GO. Geometric mean maximum plasma concentration (C max ) of apomorphine was 4.31-11.2 ng/ml across APL doses and was generally lower compared with SC apomorphine formulations within dose groups. Area under the concentration-time curve from time 0 to infinity (AUC ∞ ) was similar across apomorphine formulations within most dose groups. Relative bioavailability of APL was ~ 17% of SC apomorphine by AUC ∞ ; SC-APO and SC-APO-GO had similar bioavailability (98% and 83% by AUC ∞  and C max , respectively). Apomorphine sulfate exposure was ~ three-fold higher for APL versus SC-APO and SC-APO-GO by AUC ∞  and C max .
CONCLUSION


In patients with PD and ""OFF"" episodes, APL demonstrated lower C max  and relative bioavailability but similar exposures (AUCs) versus SC apomorphine within the approved dose range.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03292016.",2021,"RESULTS


Median time to maximum plasma concentration (t max ) of apomorphine was 0.63-0.75 h for APL and 0.25-0.38 h for SC-APO and SC-APO-GO.","[""patients with Parkinson's disease (PD"", 'Patients with Parkinson\'s Disease and ""OFF"" Episodes', 'Patients with PD and ""OFF"" episodes']","['apomorphine sublingual film (APL; KYNMOBI ® ', 'Apomorphine Sublingual Film and Subcutaneous Apomorphine Formulations', 'APL and two subcutaneous (SC) apomorphine formulations (SC-APO [APOKYN ® ] and SC-APO-GO', 'apomorphine and apomorphine sulfate (major inactive metabolite', 'SC-APO and SC-APO-GO', 'APL doses with similar plasma exposure (15/20/25/30\xa0mg) with\u2009≥\u20091-day washout between formulations']","['Median time to maximum plasma concentration (t max ) of apomorphine', 'C max  and relative bioavailability', 'Apomorphine sulfate exposure', 'Geometric mean maximum plasma concentration (C max ) of apomorphine', 'Relative bioavailability of APL', 'bioavailability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]","[{'cui': 'C0003596', 'cui_str': 'Apomorphine'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C1589388', 'cui_str': 'Apokyn'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003596', 'cui_str': 'Apomorphine'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1704608', 'cui_str': 'Film'}]",,0.0765772,"RESULTS


Median time to maximum plasma concentration (t max ) of apomorphine was 0.63-0.75 h for APL and 0.25-0.38 h for SC-APO and SC-APO-GO.","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Agbo', 'Affiliation': 'Clinical Pharmacology, Modeling and Simulation, Sunovion Pharmaceuticals Inc., One Bridge Plaza North, Suite 510, Fort Lee, NJ, 07024, USA. Felix.Agbo@sunovion.com.'}, {'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA.""}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Gil', 'Affiliation': ""Parkinson's Disease Treatment Center of Southwest Florida, Port Charlotte, FL, USA.""}, {'ForeName': 'Yu-Yuan', 'Initials': 'YY', 'LastName': 'Chiu', 'Affiliation': 'Clinical Pharmacology, Modeling and Simulation, Sunovion Pharmaceuticals Inc., One Bridge Plaza North, Suite 510, Fort Lee, NJ, 07024, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Brantley', 'Affiliation': 'Nuventra, Inc., Durham, NC, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Bhargava', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Navia', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}]",Neurology and therapy,['10.1007/s40120-021-00251-6']
770,33981951,"Physical Activity, Weight, and Outcomes in Patients Receiving Chemotherapy for Metastatic Breast Cancer (C40502/Alliance).","Background


Obesity and inactivity are associated with increased risk of cancer-related and overall mortality in breast cancer, but there are few data in metastatic disease.
Methods


Cancer and Leukemia Group B 40502 was a randomized trial of first-line taxane-based chemotherapy for patients with metastatic breast cancer. Height and weight were collected at enrollment. After 299 patients enrolled, the study was amended to assess recreational physical activity (PA) at enrollment using the Nurses' Health Study Exercise Questionnaire. Associations with progression-free survival (PFS) and overall survival (OS) were evaluated using stratified Cox modeling (strata included hormone receptor status, prior taxane, bevacizumab use, and treatment arm). All statistical tests were 2-sided.
Results


A total of 799 patients were enrolled, and at the time of data lock, median follow-up was 60 months. At enrollment, median age was 56.7 years, 73.1% of participants had hormone receptor-positive cancers, 42.6% had obesity, and 47.6% engaged in less than 3 metabolic equivalents of task (MET) hours of PA per week (<1 hour of moderate PA). Neither baseline body mass index nor PA was statistically significantly associated with PFS or OS, although there was a marginally statistically significant increase in PFS (hazard ratio = 0.83, 95% confidence interval = 0.79 to 1.02;  P  = .08) and OS (hazard ratio = 0.81, 95% confidence interval = 0.65 to 1.02;  P  = .07) in patients who reported PA greater than 9 MET hours per week vs 0-9 MET hours per week.
Conclusions


In a trial of first-line chemotherapy for metastatic breast cancer, rates of obesity and inactivity were high. There was no statistically significant relationship between body mass index and outcomes. More information is needed regarding the relationship between PA and outcomes.",2021,"Neither baseline body mass index nor PA was statistically significantly associated with PFS or OS, although there was a marginally statistically significant increase in PFS (hazard ratio = 0.83, 95% confidence interval = 0.79 to 1.02;  P  = .08) and OS (hazard ratio = 0.81, 95% confidence interval = 0.65 to 1.02;  P  = .07) in patients who reported PA greater than 9 MET hours per week vs 0-9 MET hours per week.
","['Patients', 'At enrollment, median age was 56.7\u2009years, 73.1% of participants had hormone receptor-positive cancers, 42.6% had obesity, and 47.6% engaged in less than 3 metabolic equivalents of task (MET) hours of PA per week (<1\u2009hour of moderate PA', '799 patients were enrolled, and at the time of data lock, median follow-up was 60\u2009months', 'patients with metastatic breast cancer', ""299 patients enrolled, the study was amended to assess recreational physical activity (PA) at enrollment using the Nurses' Health Study Exercise Questionnaire"", 'Metastatic Breast Cancer (C40502/Alliance']","['Chemotherapy', 'line chemotherapy', 'line taxane-based chemotherapy']","['Physical Activity, Weight, and Outcomes', 'baseline body mass index nor PA', 'PFS', 'progression-free survival (PFS) and overall survival (OS', 'Height and weight']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C2983100', 'cui_str': 'Metabolic equivalent of task'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}]",799.0,0.303475,"Neither baseline body mass index nor PA was statistically significantly associated with PFS or OS, although there was a marginally statistically significant increase in PFS (hazard ratio = 0.83, 95% confidence interval = 0.79 to 1.02;  P  = .08) and OS (hazard ratio = 0.81, 95% confidence interval = 0.65 to 1.02;  P  = .07) in patients who reported PA greater than 9 MET hours per week vs 0-9 MET hours per week.
","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Ligibel', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Huebner', 'Affiliation': 'Alliance Statistics and Data Center, Rochester, MN, USA.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Harold J', 'Initials': 'HJ', 'LastName': 'Burstein', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Toppmeyer', 'Affiliation': 'Department of Medicine, Robert Wood Johnson Medical School, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Carey K', 'Initials': 'CK', 'LastName': 'Anders', 'Affiliation': 'Department of Medicine, Duke University, Division of Medical Oncology, Duke Cancer Institute, Duke Medical Center, Durham, NC, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Barry', 'Affiliation': 'Alliance Statistics and Data Center, Rochester, MN, USA.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Suman', 'Affiliation': 'Alliance Statistics and Data Center, Rochester, MN, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Clifford A', 'Initials': 'CA', 'LastName': 'Hudis', 'Affiliation': 'American Society of Clinical Oncology, Alexandria, VA, USA.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.'}]",JNCI cancer spectrum,['10.1093/jncics/pkab025']
771,33985991,Phase 1/2 Study of Lumasiran for Treatment of Primary Hyperoxaluria Type 1: A Placebo-Controlled Randomized Clinical Trial.,"BACKGROUND AND OBJECTIVES


In the rare disease primary hyperoxaluria type 1, overproduction of oxalate by the liver causes kidney stones, nephrocalcinosis, kidney failure, and systemic oxalosis. Lumasiran, an RNA interference therapeutic, suppresses glycolate oxidase, reducing hepatic oxalate production. The objective of this first-in-human, randomized, placebo-controlled trial was to evaluate the safety, pharmacokinetic, and pharmacodynamic profiles of lumasiran in healthy participants and patients with primary hyperoxaluria type 1.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


This phase 1/2 study was conducted in two parts. In part A, healthy adults randomized 3:1 received a single subcutaneous dose of lumasiran or placebo in ascending dose groups (0.3-6 mg/kg). In part B, patients with primary hyperoxaluria type 1 randomized 3:1 received up to three doses of lumasiran or placebo in cohorts of 1 or 3 mg/kg monthly or 3 mg/kg quarterly. Patients initially assigned to placebo crossed over to lumasiran on day 85. The primary outcome was incidence of adverse events. Secondary outcomes included pharmacokinetic and pharmacodynamic parameters, including measures of oxalate in patients with primary hyperoxaluria type 1. Data were analyzed using descriptive statistics.
RESULTS


Thirty-two healthy participants and 20 adult and pediatric patients with primary hyperoxaluria type 1 were enrolled. Lumasiran had an acceptable safety profile, with no serious adverse events or study discontinuations attributed to treatment. In part A, increases in mean plasma glycolate concentration, a measure of target engagement, were observed in healthy participants. In part B, patients with primary hyperoxaluria type 1 had a mean maximal reduction from baseline of 75% across dosing cohorts in 24-hour urinary oxalate excretion. All patients achieved urinary oxalate levels ≤1.5 times the upper limit of normal.
CONCLUSIONS


Lumasiran had an acceptable safety profile and reduced urinary oxalate excretion in all patients with primary hyperoxaluria type 1 to near-normal levels.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Study of Lumasiran in Healthy Adults and Patients with Primary Hyperoxaluria Type 1, NCT02706886.",2021,"Lumasiran had an acceptable safety profile, with no serious adverse events or study discontinuations attributed to treatment.","['healthy participants', 'Healthy Adults and Patients with Primary Hyperoxaluria Type 1, NCT02706886', 'healthy participants and patients with primary hyperoxaluria type 1', 'patients with primary hyperoxaluria type', 'healthy adults', 'Thirty-two healthy participants and 20 adult and pediatric patients with primary hyperoxaluria type 1 were enrolled']","['Placebo', 'placebo', 'Lumasiran', 'lumasiran or placebo']","['incidence of adverse events', 'urinary oxalate excretion', 'safety, pharmacokinetic, and pharmacodynamic profiles of lumasiran', 'mean plasma glycolate concentration', 'urinary oxalate levels', 'mean maximal reduction', 'pharmacokinetic and pharmacodynamic parameters, including measures of oxalate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0268164', 'cui_str': 'Primary hyperoxaluria, type I'}, {'cui': 'C0020501', 'cui_str': 'Primary hyperoxaluria'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0029988', 'cui_str': 'Oxalate'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017948', 'cui_str': 'Hydroxyacetates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0202153', 'cui_str': 'Oxalate measurement'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",32.0,0.455565,"Lumasiran had an acceptable safety profile, with no serious adverse events or study discontinuations attributed to treatment.","[{'ForeName': 'Yaacov', 'Initials': 'Y', 'LastName': 'Frishberg', 'Affiliation': 'Division of Pediatric Nephrology, Shaare Zedek Medical Center, Jerusalem, Israel yaacovf@ekmd.huji.ac.il.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Deschênes', 'Affiliation': 'Department of Pediatric Nephrology, Hôpital Robert Debré, Paris, France.'}, {'ForeName': 'Jaap W', 'Initials': 'JW', 'LastName': 'Groothoff', 'Affiliation': 'Department of Pediatric Nephrology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Sally-Anne', 'Initials': 'SA', 'LastName': 'Hulton', 'Affiliation': ""Department of Nephrology, Birmingham Women's and Children's Hospital, Birmingham, United Kingdom.""}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Magen', 'Affiliation': ""Pediatric Nephrology Institute, Ruth Children's Hospital, Haifa, Israel.""}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Harambat', 'Affiliation': 'Pediatric Nephrology Unit, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': ""Van't Hoff"", 'Affiliation': 'Department of Paediatric Nephrology, Great Ormond Street Hospital, London, United Kingdom.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lorch', 'Affiliation': 'Richmond Pharmacology Ltd., London, United Kingdom.'}, {'ForeName': 'Dawn S', 'Initials': 'DS', 'LastName': 'Milliner', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Lieske', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Haslett', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts.'}, {'ForeName': 'Pushkal P', 'Initials': 'PP', 'LastName': 'Garg', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts.'}, {'ForeName': 'Akshay K', 'Initials': 'AK', 'LastName': 'Vaishnaw', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Talamudupula', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts.'}, {'ForeName': 'Jiandong', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts.'}, {'ForeName': 'Bahru A', 'Initials': 'BA', 'LastName': 'Habtemariam', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts.'}, {'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Erbe', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'McGregor', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, Massachusetts.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Cochat', 'Affiliation': 'Center for Rare Renal Diseases and Institut National de la Santé et de la Recherche Médicale Pediatric Clinical Investigation Center, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.14730920']
772,33989786,A Preliminary Study of Provider Burden in the Treatment of Chronic Pain: Perspectives of Physicians and People with Chronic Pain.,"This study compared perceptions of the burden of patient care and associated clinical judgments between physicians and people with chronic pain (PWCP) in a 2 × 3 × 2 between-subjects design that varied participant type, patient-reported pain severity (4/6-8/10), and supporting medical evidence (low/high). One hundred and nine physicians and 476 American Chronic Pain Association members were randomly assigned to 1 of 6 conditions. Respondents estimated the clinical burden they would assume as the treating physician of a hypothetical patient with chronic low back pain, and made clinical judgments regarding that patient. Physician burden ratings were significantly higher than PWCP ratings, and clinical impressions (eg, trust in pain report, medical attribution) and management concerns (eg, opioid abuse risk) were relatively less favorable. Neither pain severity nor medical evidence affected burden ratings significantly. High medical evidence was associated with more favorable clinical impressions; higher pain severity led to more discounting of patient pain reports. Burden was significantly correlated with a range of clinical judgments. Results indicate that physicians and PWCP differ in their perceptions of provider burden and related clinical judgments in ways that could impact treatment collaboration. Further research is needed that examines provider burden in actual clinical practice. PERSPECTIVE: Physicians and people with chronic pain (PWCP) estimated the clinical burden of patient care and made judgments about a hypothetical patient with chronic pain. Physician burden ratings were higher and clinical judgments less favorable, relative to PWCP respondents. These differences could impact treatment collaboration and merit study in clinical practice.",2021,High medical evidence was associated with more favorable clinical impressions; higher pain severity led to more discounting of patient pain reports.,"['physicians and people with chronic pain (PWCP) in a 2\u202f×\u202f3\u202f×\u202f2 between-subjects design that varied participant type, patient-reported pain severity (4-6-8/10), and supporting medical evidence (low/high', 'Perspective Physicians and people with chronic pain (PWCP', 'Physicians and People with Chronic Pain', '109 physicians and 476 American Chronic Pain Association members']",[],"['Physician burden ratings', 'PWCP ratings, and clinical impressions (e.g., trust in pain report, medical attribution) and management concerns (e.g., opioid abuse risk']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]",[],"[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0029095', 'cui_str': 'Opioid abuse'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.132073,High medical evidence was associated with more favorable clinical impressions; higher pain severity led to more discounting of patient pain reports.,"[{'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Tait', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Saint Louis University School of Medicine, St. Louis, Missouri. Electronic address: raymond.tait@health.slu.edu.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Chibnall', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Saint Louis University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Kalauokalani', 'Affiliation': 'American Chronic Pain Association, Rocklin, California.'}]",The journal of pain,['10.1016/j.jpain.2021.04.009']
773,33981301,"Islet Autoimmunity in Adults With Impaired Glucose Tolerance and Recently Diagnosed, Treatment Naïve Type 2 Diabetes in the Restoring Insulin SEcretion (RISE) Study.","The presence of islet autoantibodies and islet reactive T cells (T+) in adults with established type 2 diabetes (T2D) have been shown to identify those patients with more severe β-cell dysfunction. However, at what stage in the progression toward clinical T2D does islet autoimmunity emerge as an important component influencing β-cell dysfunction? In this ancillary study to the Restoring Insulin SEcretion (RISE) Study, we investigated the prevalence of and association with β-cell dysfunction of T+ and autoantibodies to the 65 kDa glutamic acid decarboxylase antigen (GADA) in obese pre-diabetes adults with impaired glucose tolerance (IGT) and recently diagnosed treatment naïve (Ndx) T2D. We further investigated the effect of 12 months of RISE interventions (metformin or liraglutide plus metformin, or with 3 months of insulin glargine followed by 9 months of metformin or placebo) on islet autoimmune reactivity. We observed GADA(+) in 1.6% of NdxT2D and 4.6% of IGT at baseline, and in 1.6% of NdxT2D and 5.3% of IGT at 12 months, but no significant associations between GADA(+) and β-cell function. T(+) was observed in 50% of NdxT2D and 60.4% of IGT at baseline, and in 68.4% of NdxT2D and 83.9% of IGT at 12 months. T(+) NdxT2D were observed to have significantly higher fasting glucose ( p  = 0.004), and 2 h glucose ( p  = 0.0032), but significantly lower steady state C-peptide (sscpep,  p  = 0.007) compared to T(-) NdxT2D. T(+) IGT participants demonstrated lower but not significant ( p  = 0.025) acute (first phase) C-peptide response to glucose (ACPRg) compared to T(-) IGT. With metformin treatment, T(+) participants were observed to have a significantly lower Hemoglobin A1c (HbA1c,  p  = 0.002) and fasting C-peptide ( p  = 0.002) compared to T(-), whereas T(+) treated with liraglutide + metformin had significantly lower sscpep ( p  = 0.010) compared to T(-) participants. In the placebo group, T(+) participants demonstrated significantly lower ACPRg ( p  = 0.001) compared to T(-) participants. In summary, T(+) were found in a large percentage of obese pre-diabetes adults with IGT and in recently diagnosed T2D. Moreover, T(+) were significantly correlated with treatment effects and β-cell dysfunction. Our results demonstrate that T(+) are an important component in T2D.",2021,"In the placebo group, T(+) participants demonstrated significantly lower ACPRg ( p  = 0.001) compared to T(-) participants.","['Adults With Impaired Glucose Tolerance and Recently Diagnosed, Treatment Naïve Type 2 Diabetes in the Restoring Insulin SEcretion (RISE) Study', 'adults with established type 2 diabetes (T2D', 'obese pre-diabetes adults with IGT and in recently diagnosed T2D', 'obese pre-diabetes adults with impaired glucose tolerance (IGT) and recently diagnosed treatment naïve']","['65 kDa glutamic acid decarboxylase antigen (GADA', 'T', 'liraglutide + metformin', 'metformin', 'RISE interventions (metformin or liraglutide plus metformin, or with 3 months of insulin glargine', 'metformin or placebo', 'placebo']","['Restoring Insulin SEcretion (RISE', 'steady state C-peptide (sscpep,  p  = 0.007) compared to T(-) NdxT2D. T', 'fasting glucose', 'islet autoantibodies and islet reactive T cells (T', 'fasting C-peptide', 'islet autoimmune reactivity', 'ACPRg', 'Hemoglobin A1c']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C1532717', 'cui_str': 'kDa'}, {'cui': 'C0017785', 'cui_str': 'Glutamate decarboxylase'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0443146', 'cui_str': 'Autoimmune reaction'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.175118,"In the placebo group, T(+) participants demonstrated significantly lower ACPRg ( p  = 0.001) compared to T(-) participants.","[{'ForeName': 'Barbara M', 'Initials': 'BM', 'LastName': 'Brooks-Worrell', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Ashley H', 'Initials': 'AH', 'LastName': 'Tjaden', 'Affiliation': 'Biostatistics Center, Milken School of Public Health, George Washington University Biostatistics Center, Rockville, MD, United States.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'Biostatistics Center, Milken School of Public Health, George Washington University Biostatistics Center, Rockville, MD, United States.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Palomino', 'Affiliation': 'Seattle Institute for Biochemical and Clinical Research, Seattle, WA, United States.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Arslanian', 'Affiliation': ""Department of Medicine, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, Pittsburgh, PA, United States.""}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Indiana University School of Medicine, Richard L. Roudebush Veterans Affairs Medical Center, Indianapolis, IN, United States.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': 'University of Southern California Keck School of Medicine/Kaiser Permanente Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ""University of Colorado Anschutz Medical Campus/Children's Hospital Colorado, Aurora, CO, United States.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Atkinson', 'Affiliation': 'Veterans Affairs Puget Sound Health Care System, Seattle, WA, United States.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barengolts', 'Affiliation': 'University of Chicago Clinical Research Center and Jesse Brown Veterans Affairs Medical Center, Chicago, IL, United States.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Palmer', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Frontiers in immunology,['10.3389/fimmu.2021.640251']
774,33991341,Direct comparison of risankizumab and fumaric acid esters in systemic therapy-naïve patients with moderate-to-severe plaque psoriasis: a randomized controlled trial.,"BACKGROUND


Fumaric acid esters (FAEs; Fumaderm ®  ) are the most frequently prescribed first-line systemic treatment for moderate-to-severe plaque psoriasis in Germany. Risankizumab (Skyrizi ®  ) is a humanized IgG1 monoclonal antibody that specifically binds to the p19 subunit of interleukin 23.
OBJECTIVES


To compare risankizumab treatment to FAEs in patients with psoriasis.
METHODS


This phase III randomized, active-controlled, open-label study with blinded assessment of efficacy was conducted in Germany. Patients were randomized (1 : 1) to subcutaneous risankizumab 150 mg (weeks 0, 4 and 16) or oral FAEs at increasing doses from 30 mg daily (week 0) up to 720 mg daily (weeks 8-24). Enrolled patients were adults naïve to and candidates for systemic therapy, with chronic moderate-to-severe plaque psoriasis. Phototherapy was not allowed within 14 days before or during the study.
RESULTS


Key efficacy endpoints were met at week 24 for risankizumab (n = 60) vs. FAEs (n = 60) (P < 0·001): achievement of a ≥ 90% improvement in Psoriasis Area and Severity Index (PASI; primary endpoint 83·3% vs. 10·0%), ≥ 100% improvement in PASI (50·0% vs. 5·0%), ≥ 75% improvement in PASI (98·3% vs. 33·3%), ≥ 50% improvement in PASI (100% vs. 53·3%) and a Static Physician's Global Assessment of clear/almost clear (93·3% vs. 38·3%). The rates of gastrointestinal disorders, flushing, lymphopenia and headache were higher in the FAE group. One patient receiving risankizumab reported a serious infection (influenza, which required hospitalization). There were no malignancies, tuberculosis or opportunistic infections in either treatment arm.
CONCLUSIONS


Risankizumab was found to be superior to FAEs, providing earlier and greater improvement in psoriasis outcomes that persisted with continued treatment, and more favourable safety results, which is consistent with the known safety profile. No new safety signals for risankizumab or FAEs were observed.",2022,"The rates of gastrointestinal disorders, flushing, lymphopenia, and headache were higher in the FAEs group.","['Enrolled patients were adults naive to and candidates for systemic therapy, with chronic, moderate-to-severe plaque psoriasis', 'Systemic-Therapy-Naive Patients With Moderate to Severe Plaque Psoriasis', 'psoriasis patients']","['Risankizumab (Skyrizi ®  ', 'risankizumab treatment with FAEs', 'subcutaneous risankizumab', 'risankizumab', 'Risankizumab and Fumaric Acid Esters', 'Phototherapy', 'oral FAEs']","[""Static Physician's Global Assessment of clear/almost clear"", 'rates of gastrointestinal disorders, flushing, lymphopenia, and headache', 'serious infection (influenza requiring hospitalization', 'malignancies, tuberculosis, or opportunistic infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0919936', 'cui_str': 'Therapy naive'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C4766123', 'cui_str': 'Skyrizi'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1959568', 'cui_str': 'Fumarate Esters'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}]",,0.196472,"The rates of gastrointestinal disorders, flushing, lymphopenia, and headache were higher in the FAEs group.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Eyerich', 'Affiliation': 'Department of Dermatology and Allergy, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinter', 'Affiliation': 'Department of Dermatology, Venerology and Allergology, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sebastian', 'Affiliation': 'Gemeinschaftspraxis für Dermatologie, Mahlow, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Unnebrink', 'Affiliation': 'AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rubant', 'Affiliation': 'AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Weisenseel', 'Affiliation': 'Dermatologikum, Hamburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.20481']
775,34000245,"Adjuvant and concurrent temozolomide for 1p/19q non-co-deleted anaplastic glioma (CATNON; EORTC study 26053-22054): second interim analysis of a randomised, open-label, phase 3 study.","BACKGROUND


The CATNON trial investigated the addition of concurrent, adjuvant, and both current and adjuvant temozolomide to radiotherapy in adults with newly diagnosed 1p/19q non-co-deleted anaplastic gliomas. The benefit of concurrent temozolomide chemotherapy and relevance of mutations in the IDH1 and IDH2 genes remain unclear.
METHODS


This randomised, open-label, phase 3 study done in 137 institutions across Australia, Europe, and North America included patients aged 18 years or older with newly diagnosed 1p/19q non-co-deleted anaplastic gliomas and a WHO performance status of 0-2. Patients were randomly assigned (1:1:1:1) centrally using a minimisation technique to radiotherapy alone (59·4 Gy in 33 fractions; three-dimensional conformal radiotherapy or intensity-modulated radiotherapy), radiotherapy with concurrent oral temozolomide (75 mg/m 2  per day), radiotherapy with adjuvant oral temozolomide (12 4-week cycles of 150-200 mg/m 2  temozolomide given on days 1-5), or radiotherapy with both concurrent and adjuvant temozolomide. Patients were stratified by institution, WHO performance status score, age, 1p loss of heterozygosity, the presence of oligodendroglial elements on microscopy, and MGMT promoter methylation status. The primary endpoint was overall survival adjusted by stratification factors at randomisation in the intention-to-treat population. A second interim analysis requested by the independent data monitoring committee was planned when two-thirds of total required events were observed to test superiority or futility of concurrent temozolomide. This study is registered with ClinicalTrials.gov, NCT00626990.
FINDINGS


Between Dec 4, 2007, and Sept 11, 2015, 751 patients were randomly assigned (189 to radiotherapy alone, 188 to radiotherapy with concurrent temozolomide, 186 to radiotherapy and adjuvant temozolomide, and 188 to radiotherapy with concurrent and adjuvant temozolomide). Median follow-up was 55·7 months (IQR 41·0-77·3). The second interim analysis declared futility of concurrent temozolomide (median overall survival was 66·9 months [95% CI 45·7-82·3] with concurrent temozolomide vs 60·4 months [45·7-71·5] without concurrent temozolomide; hazard ratio [HR] 0·97 [99·1% CI 0·73-1·28], p=0·76). By contrast, adjuvant temozolomide improved overall survival compared with no adjuvant temozolomide (median overall survival 82·3 months [95% CI 67·2-116·6] vs 46·9 months [37·9-56·9]; HR 0·64 [95% CI 0·52-0·79], p<0·0001). The most frequent grade 3 and 4 toxicities were haematological, occurring in no patients in the radiotherapy only group, 16 (9%) of 185 patients in the concurrent temozolomide group, and 55 (15%) of 368 patients in both groups with adjuvant temozolomide. No treatment-related deaths were reported.
INTERPRETATION


Adjuvant temozolomide chemotherapy, but not concurrent temozolomide chemotherapy, was associated with a survival benefit in patients with 1p/19q non-co-deleted anaplastic glioma. Clinical benefit was dependent on IDH1 and IDH2 mutational status.
FUNDING


Merck Sharpe & Dohme.",2021,Median follow-up was 55·7 months,"['patients with 1p/19q non-co-deleted anaplastic glioma', '137 institutions across Australia, Europe, and North America included patients aged 18 years or older with newly diagnosed 1p/19q non-co-deleted anaplastic gliomas and a WHO performance status of 0-2', 'adults with newly diagnosed 1p/19q non-co-deleted anaplastic gliomas', 'Patients were stratified by institution, WHO performance status score, age, 1p loss of heterozygosity, the presence of oligodendroglial elements on microscopy, and MGMT promoter methylation status']","['Adjuvant and concurrent temozolomide', 'temozolomide to radiotherapy', 'radiotherapy with both concurrent and adjuvant temozolomide', 'minimisation technique to radiotherapy alone (59·4 Gy in 33 fractions; three-dimensional conformal radiotherapy or intensity-modulated radiotherapy), radiotherapy with concurrent oral temozolomide', 'temozolomide chemotherapy', 'temozolomide', 'radiotherapy with concurrent temozolomide, 186 to radiotherapy and adjuvant temozolomide, and 188 to radiotherapy with concurrent and adjuvant temozolomide', 'radiotherapy', 'radiotherapy with adjuvant oral temozolomide', 'Adjuvant temozolomide chemotherapy']","['overall survival', 'survival benefit']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0524869', 'cui_str': 'Heterozygosity, Loss of'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0069197', 'cui_str': 'Methylated-DNA-protein-cysteine methyltransferase'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",751.0,0.296586,Median follow-up was 55·7 months,"[{'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'Brain Tumor Center, Erasmus MC Cancer Institute, Rotterdam, Netherlands. Electronic address: m.vandenbent@erasmusmc.nl.'}, {'ForeName': 'C Mircea S', 'Initials': 'CMS', 'LastName': 'Tesileanu', 'Affiliation': 'Brain Tumor Center, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Neurologische Klinik und Nationales Zentrum für Tumorerkrankungen Universitätsklinik Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sanson', 'Affiliation': 'Sorbonne Universités, Inserm, CNRS, UMR S 1127, Institut du Cerveau et de la Moelle épinière, ICM AP-HP, Paris, France; Hôpital Univeristaires Pitié-salpêtrière -Chales Foix, service de Neurologie 2-Mazarin, Paris, France.'}, {'ForeName': 'Alba Ariela', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'Medical Oncology Department, AUSL-IRCCS Scienze Neurologiche, Bologna, Italy.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Clement', 'Affiliation': 'Department of Oncology, KU Leuven and Department of General Medical Oncology, UZ Leuven, Leuven Cancer Institute, Leuven, Belgium.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Erridge', 'Affiliation': 'Edinburgh Centre for Neuro-Oncology, Western General Hospital, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Vogelbaum', 'Affiliation': 'Department of NeuroOncology, Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Nowak', 'Affiliation': 'Medical School of Medicine and Pharmacology, University of Western Australia, Crawley, WA, Australia; CoOperative Group for NeuroOncology, University of Sydney, Camperdown, NSW, Australia; Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'Jean Français', 'Initials': 'JF', 'LastName': 'Baurain', 'Affiliation': 'Medical Oncology Department, King Albert II Cancer Institute, Cliniques universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Warren P', 'Initials': 'WP', 'LastName': 'Mason', 'Affiliation': 'Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Wheeler', 'Affiliation': 'Northern Sydney Cancer Centre, St Leonards, Sydney, NSW, Australia.'}, {'ForeName': 'Olivier L', 'Initials': 'OL', 'LastName': 'Chinot', 'Affiliation': 'Aix-Marseille University, AP-HM, Neuro-Oncology division, Marseille, France.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': 'Department of Medical Oncology, Alfred Hospital, Melbourne, QLD, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'Department of Clinical Oncology, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Leland', 'Initials': 'L', 'LastName': 'Rogers', 'Affiliation': 'Department of Radiation Oncology, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Taal', 'Affiliation': 'Brain Tumor Center, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Rudà', 'Affiliation': 'Department of Neuro-Oncology, City of Health and Science Hospital and University of Turin, Turin, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology and Brain Tumor Center, University Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'McBain', 'Affiliation': 'Department of Clinical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Reijneveld', 'Affiliation': 'Brain Tumor Center Amsterdam and Department of Neurology, VU University Medical Center, Amsterdam, Netherlands; Department of Neurology, Academic Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Roelien H', 'Initials': 'RH', 'LastName': 'Enting', 'Affiliation': 'Department of Neurology, UMCG, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Caparrotti', 'Affiliation': 'Department of Radiation Oncology, University Hospital of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lesimple', 'Affiliation': 'Department of Clinical Oncology, Comprehensive Cancer Center Eugène Marquis, Rennes, France.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Clenton', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Gijtenbeek', 'Affiliation': 'Department of Neurology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lim', 'Affiliation': 'Department of Clinical Oncology, Plymouth Hospitals NHS Trust, Plymouth, UK.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Herrlinger', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology, University of Bonn Medical Center, Bonn, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hau', 'Affiliation': 'Wilhelm Sander-NeuroOncology Unit and Department of Neurology, University Hospital, Regensburg, Regensburg, Germany.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Dhermain', 'Affiliation': 'Radiotherapy Department, Gustave Roussy University Hospital, Villejuif, Cedex, France.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'de Heer', 'Affiliation': 'Brain Tumor Center, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Aldape', 'Affiliation': 'Laboratory of Pathology, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Jenkins', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester MN, USA.'}, {'ForeName': 'Hendrikus Jan', 'Initials': 'HJ', 'LastName': 'Dubbink', 'Affiliation': 'Department of Pathology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Johan M', 'Initials': 'JM', 'LastName': 'Kros', 'Affiliation': 'Department of Pathology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Wesseling', 'Affiliation': 'Department of Pathology, Amsterdam University Medical Centers, Amsterdam, Netherlands; Princess Máxima Center for Pediatric Oncology, Utrecht, Netherlands; Department of Pathology, Radboud University Nijmegen Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nuyens', 'Affiliation': 'EORTC, Brussels, Belgium.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Golfinopoulos', 'Affiliation': 'EORTC, Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gorlia', 'Affiliation': 'EORTC, Brussels, Belgium.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'French', 'Affiliation': 'Brain Tumor Center, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Brigitta G', 'Initials': 'BG', 'LastName': 'Baumert', 'Affiliation': 'Department of Radiation-Oncology (MAASTRO), Maastricht University Medical Center (MUMC) GROW (School for Oncology), Maastricht, Netherlands; Institute of Radiation-Oncology, Cantonal Hospital Graubünden, Chur, Switzerland.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00090-5']
776,33988236,Long-Term Effectiveness of Oral Ferric Maltol vs Intravenous Ferric Carboxymaltose for the Treatment of Iron-Deficiency Anemia in Patients With Inflammatory Bowel Disease: A Randomized Controlled Noninferiority Trial.,"BACKGROUND


Iron-deficiency anemia is common in inflammatory bowel disease, requiring oral or intravenous iron replacement therapy. Treatment with standard oral irons is limited by poor absorption and gastrointestinal toxicity. Ferric maltol is an oral iron designed for improved absorption and tolerability.
METHODS


In this open-label, phase 3b trial (EudraCT 2015-002496-26 and NCT02680756), adults with nonseverely active inflammatory bowel disease and iron-deficiency anemia (hemoglobin, 8.0-11.0/12.0 g/dL [women/men]; ferritin, <30 ng/mL/<100 ng/mL with transferrin saturation <20%) were randomized to oral ferric maltol 30 mg twice daily or intravenous ferric carboxymaltose given according to each center's standard practice. The primary endpoint was a hemoglobin responder rate (≥2 g/dL increase or normalization) at week 12, with a 20% noninferiority limit in the intent-to-treat and per-protocol populations.
RESULTS


For the intent-to-treat (ferric maltol, n = 125/ferric carboxymaltose, n = 125) and per-protocol (n = 78/88) analyses, week 12 responder rates were 67% and 68%, respectively, for ferric maltol vs 84% and 85%, respectively, for ferric carboxymaltose. As the confidence intervals crossed the noninferiority margin, the primary endpoint was not met. Mean hemoglobin increases at weeks 12, 24, and 52 were 2.5 vs 3.0 g/dL, 2.9 vs 2.8 g/dL, and 2.7 vs 2.8 g/dL with ferric maltol vs ferric carboxymaltose. Treatment-emergent adverse events occurred in 59% and 36% of patients, respectively, and resulted in treatment discontinuation in 10% and 3% of patients, respectively.
CONCLUSIONS


Ferric maltol achieved clinically relevant increases in hemoglobin but did not show noninferiority vs ferric carboxymaltose at week 12. Both treatments had comparable long-term effectiveness for hemoglobin and ferritin over 52 weeks and were well tolerated.",2022,"CONCLUSIONS


Ferric maltol achieved clinically relevant increases in hemoglobin but did not show noninferiority vs ferric carboxymaltose at week 12.","['adults with nonseverely active inflammatory bowel disease and iron-deficiency anemia (hemoglobin, 8.0-11.0/12.0 g/dL', 'Patients With Inflammatory Bowel Disease', 'women/men]; ferritin, <30 ng/mL/<100 ng/mL with transferrin saturation <20']","['oral ferric maltol 30 mg twice daily or intravenous ferric carboxymaltose', 'ferric carboxymaltose', 'Oral Ferric Maltol vs Intravenous Ferric Carboxymaltose', 'ferric maltol vs ferric carboxymaltose']","['absorption and tolerability', 'Mean hemoglobin', 'tolerated', 'hemoglobin', 'Treatment-emergent adverse events', 'hemoglobin responder rate (≥2 g/dL increase or normalization']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0060237', 'cui_str': 'ferric maltol'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}]","[{'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.135496,"CONCLUSIONS


Ferric maltol achieved clinically relevant increases in hemoglobin but did not show noninferiority vs ferric carboxymaltose at week 12.","[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Howaldt', 'Affiliation': 'Research Institute for IBD-HaFCED e.K., Hamburg, Germany.'}, {'ForeName': 'Eugeni', 'Initials': 'E', 'LastName': 'Domènech', 'Affiliation': 'Gastroenterology and Hepatology Department, Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, and Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Madrid, Spain.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Martinez', 'Affiliation': 'Gastroenterology Research of America, San Antonio, Texas, USA.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schmidt', 'Affiliation': 'Department of Gastroenterology, Hepatology, Endocrinology, Diabetology, and Infectious Diseases, Klinikum Fulda, Fulda, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Bokemeyer', 'Affiliation': 'Gastroenterology Practice Minden and University Hospital Schleswig-Holstein, Campus Kiel, Clinic for Internal Medicine I, Kiel, Germany.'}]",Inflammatory bowel diseases,['10.1093/ibd/izab073']
777,34007017,Outcomes of older men receiving docetaxel for metastatic hormone-sensitive prostate cancer.,"BACKGROUND


Most men who die of prostate cancer are older than 70 years. The ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) randomized men of all ages with metastatic hormone-sensitive prostate cancer (mHSPC) to receive androgen deprivation therapy (ADT) with or without docetaxel demonstrating an overall survival (OS) benefit for docetaxel.
METHODS


In a post-hoc analysis of this trial, we assessed patient characteristics and OS in patients ≥70 years (""older men"") versus <70 years (""younger men"") with Cox proportional hazards models. In addition, we compared adverse events, therapy completion rate, and subsequent treatment patterns between these two groups using Chi-squared tests.
RESULTS


177 (22.4%) patients were ≥70 years. Docetaxel + ADT resulted in improved OS in both older and younger men (Hazard Ratio [HR] 0.45, 95%CI: 0.25-0.80 for older men; HR 0.71, 95%CI: 0.53-0.95 for younger men). This treatment benefit was seen for subgroups of older men with high volume disease (HR 0.43, 95%CI 0.23-0.79) and de novo metastatic disease (HR 0.36, 95%CI 0.19-0.69). A similar proportion of older and younger men completed six cycles of docetaxel (82.6% vs. 87.1%, p = 0.28). Rates of grade 3-5 adverse events were similar between older and younger men (36.8% vs. 26.8%, respectively, p = 0.069). The rate of any Grades 4-5 adverse events did not differ significantly between older and younger men (14.9% vs. 11.9%, respectively, p = 0.46). In the control arm, a smaller proportion of older men received subsequent cancer treatments (34.4% vs. 51.5%, p = 0.017) or subsequent docetaxel (25.6% vs. 37.6%, p = 0.035) compared to younger men.
CONCLUSIONS


Older men with mHSPC had similar OS benefit and clinical outcomes compared to younger men when receiving docetaxel + ADT. Oncologists should consider docetaxel chemotherapy as a favorable treatment option for older men with mHSPC who are fit for chemotherapy.",2021,"Docetaxel + ADT resulted in improved OS in both older and younger men (Hazard Ratio [HR] 0.45, 95%CI: 0.25-0.80 for older men; HR 0.71, 95%CI:","['Extensive Disease in Prostate Cancer (CHAARTED) randomized men of all ages with metastatic hormone-sensitive prostate cancer (mHSPC', 'Older men with', 'for metastatic hormone-sensitive prostate cancer', 'patients ≥70 years (""older men"") versus <70 years (""younger men"") with Cox proportional hazards models', 'older men with mHSPC who are fit for chemotherapy', 'older men receiving', 'men who die of prostate cancer are older than 70 years', '177 (22.4%) patients were ≥70 years']","['docetaxel', 'docetaxel chemotherapy', 'androgen deprivation therapy (ADT) with or without docetaxel', 'Docetaxel + ADT', 'mHSPC', 'docetaxel\u2009+\u2009ADT']","['rate of any Grades 4-5 adverse events', 'Rates of grade 3-5 adverse events', 'adverse events, therapy completion rate, and subsequent treatment patterns', 'OS']","[{'cui': 'C0849867', 'cui_str': 'Generalized illness'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0010235', 'cui_str': 'Cox Proportional Hazards Models'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.208548,"Docetaxel + ADT resulted in improved OS in both older and younger men (Hazard Ratio [HR] 0.45, 95%CI: 0.25-0.80 for older men; HR 0.71, 95%CI:","[{'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Lage', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA. dlage@mgh.harvard.edu.'}, {'ForeName': 'M Dror', 'Initials': 'MD', 'LastName': 'Michaelson', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Lee', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sweeney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-021-00389-2']
778,34010494,Sleep quality and outcome of exposure therapy in adults with social anxiety disorder.,"INTRODUCTION


Poor sleep is prevalent among individuals with social anxiety disorder (SAD) and may negatively affect exposure therapy outcomes. Poor sleep may impair memory and learning, and thus compromise fear extinction learning thought to take place in exposure therapy. We examined poor sleep as a predictor of exposure therapy outcomes for SAD and the moderating role of d-cycloserine (DCS) on this relationship.
METHODS


Participants were 152 individuals with a primary diagnosis of SAD. As part of a randomized clinical trial evaluating the efficacy of DCS for enhancing the effects of exposure therapy, they completed self-report baseline measure of sleep quality, and self-report sleep diaries assessing sleep duration (total sleep time [TST]) and sleep quality the nights before and after treatment sessions.
RESULTS


Poorer baseline sleep quality was significantly associated with slower improvement over time and worse symptom outcomes at the end of treatment and follow-up after controlling for baseline symptoms of depression and social anxiety. Greater TST the night before treatment predicted lower SAD symptoms at the next session, after controlling for symptoms at the previous session. There was no relation between prior or subsequent night sleep quality on symptoms at the next session. No associations were moderated by DCS.
CONCLUSIONS


We replicated and extended findings indicating that poor sleep quality is associated with poorer exposure therapy outcomes for SAD. Assessing for sleep difficulties before treatment initiation and incorporating sleep interventions into treatment may enhance exposure therapy outcomes for SAD.",2021,"Greater TST the night before treatment predicted lower SAD symptoms at the next session, after controlling for symptoms at the previous session.","['individuals with social anxiety disorder (SAD', 'adults with social anxiety disorder', 'Participants were 152 individuals with a primary diagnosis of SAD']","['d-cycloserine (DCS', 'exposure therapy', 'DCS']","['depression and social anxiety', 'baseline sleep quality', 'Sleep quality', 'SAD symptoms', 'sleep quality, and self-report sleep diaries assessing sleep duration (total sleep time [TST]) and sleep quality the nights']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}]","[{'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",152.0,0.116116,"Greater TST the night before treatment predicted lower SAD symptoms at the next session, after controlling for symptoms at the previous session.","[{'ForeName': 'Christina D', 'Initials': 'CD', 'LastName': 'Dutcher', 'Affiliation': 'Department of Psychology, Institute for Mental Health Research, The University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Dowd', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Alyson K', 'Initials': 'AK', 'LastName': 'Zalta', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychology, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Department of Psychology, Southern Methodist University, Dallas, Texas, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Perrone', 'Affiliation': 'Department of Psychology, Institute for Mental Health Research, The University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Pollack', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Stefan G', 'Initials': 'SG', 'LastName': 'Hofmann', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Department of Psychology, Institute for Mental Health Research, The University of Texas at Austin, Austin, Texas, USA.'}]",Depression and anxiety,['10.1002/da.23167']
779,34009326,Cardiac symptom burden and arrhythmia recurrence drives digital health use: results from the iHEART randomized controlled trial.,"AIMS


Digital health can transform the management of atrial fibrillation (AF) and enable patients to take a central role in detecting symptoms and self-managing AF. There is a gap in understanding factors that support sustained use of digital health tools for patients with AF. This study identified predictors of Alivecor® KardiaMobile ECG monitor usage among patients with AF enrolled in the iPhone®Helping Evaluate Atrial fibrillation Rhythm through Technology (iHEART) randomized controlled trial.
METHODS AND RESULTS


We analysed data from 105 English and Spanish-speaking adults with AF enrolled in the intervention arm of the iHEART trial. The iHEART intervention included smartphone-based electrocardiogram self-monitoring with Alivecor® KardiaMobile and triweekly text messages for 6 months. The primary outcome was use of Alivecor® categorized as: infrequent (≤5 times/week), moderate (>5 times and ≤11 times/week), and frequent (>11 times/week). We applied multinomial logistic regression modelling to characterize frequency and predictors of use. Of the 105 participants, 25% were female, 75% were White, and 45% were ≥65 years of age. Premature atrial contractions (PACs) [adjusted odds ratio (OR): 1.23, 1.08-1.40, P = 0.002] predicted frequent as compared to infrequent use. PACs (adjusted OR: 1.17, 95% confidence interval 1.06-1.30, P = 0.003), lower symptom burden (adjusted OR: 1.06, 1.01-1.11, P = 0.02), and less treatment concern (adjusted OR: 0.96, 0.93-0.99, P = 0.02) predicted moderate as compared to infrequent use.
CONCLUSIONS


Frequent use of AliveCor® is associated with AF symptoms and potentially symptomatic cardiac events. Symptom burden and frequency should be measured and incorporated into analyses of future digital health trials for AF management.",2022,"Premature atrial contractions (PACs) [adjusted odds ratio (OR): 1.23, 1.08-1.40, P = 0.002] predicted frequent as compared to infrequent use.","['105 participants, 25% were female, 75% were White, and 45% were ≥65\u2009years of age', 'We analysed data from 105 English and Spanish-speaking adults with AF enrolled in the intervention arm of the iHEART trial', 'patients with AF', 'patients with AF enrolled in the iPhone®Helping Evaluate Atrial fibrillation Rhythm through Technology (iHEART) randomized controlled trial']",['smartphone-based electrocardiogram self-monitoring with Alivecor® KardiaMobile and triweekly text messages'],"['lower symptom burden', 'Alivecor® categorized as: infrequent (≤5 times/week), moderate', 'Premature atrial contractions (PACs']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}]",105.0,0.126049,"Premature atrial contractions (PACs) [adjusted odds ratio (OR): 1.23, 1.08-1.40, P = 0.002] predicted frequent as compared to infrequent use.","[{'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Masterson Creber', 'Affiliation': 'Division of Health Informatics, Department of Population Health Sciences, Weill Cornell Medical College, 425 East 61st Street, Suite 301, New York, NY 10065, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Reading Turchioe', 'Affiliation': 'Division of Health Informatics, Department of Population Health Sciences, Weill Cornell Medical College, 425 East 61st Street, Suite 301, New York, NY 10065, USA.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Biviano', 'Affiliation': 'Department of Medicine-Cardiology, Columbia University Irving Medical Center, New York, NY 10032, USA.'}, {'ForeName': 'Billy', 'Initials': 'B', 'LastName': 'Caceres', 'Affiliation': 'School of Nursing, Columbia University Irving Medical Center, New York, NY 10032, USA.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Garan', 'Affiliation': 'Department of Medicine-Cardiology, Columbia University Irving Medical Center, New York, NY 10032, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Goldenthal', 'Affiliation': 'Department of Medicine-Cardiology, Columbia University Irving Medical Center, New York, NY 10032, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Koleck', 'Affiliation': 'School of Nursing, Columbia University Irving Medical Center, New York, NY 10032, USA.'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Mitha', 'Affiliation': 'School of Nursing, Columbia University Irving Medical Center, New York, NY 10032, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Hickey', 'Affiliation': 'Department of Medicine-Cardiology, Columbia University Irving Medical Center, New York, NY 10032, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Bakken', 'Affiliation': 'School of Nursing, Columbia University Irving Medical Center, New York, NY 10032, USA.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1093/eurjcn/zvab009']
780,34003418,Psychological and behavioral pathways between perceived stress and weight change in a behavioral weight loss intervention.,"Black women have a higher prevalence of obesity and tend to have suboptimal outcomes in behavioral weight loss programs for reasons that are not fully understood. Studies have shown a potential relationship between perceived psychological stress and weight loss in behavioral interventions. This study sought to assess whether baseline stress was directly or indirectly associated with 6-month weight change among Black women participating in a behavioral weight loss study. Indirect pathways of interest included depressive symptoms and dietary intake. A secondary analysis of data (n = 409) collected from a cluster, randomized behavioral weight loss trial was conducted. Demographics, anthropometry, surveys, and dietary data were collected at baseline and 6 months. Path analysis was used to test for direct and indirect effects of baseline stress on 6-month weight change while controlling for sociodemographic factors and intervention group. Baseline stress was not directly associated with 6-month weight change nor was it indirectly associated via depressive symptoms in the adjusted model. However, each of the direct paths linking baseline stress to weight loss were statistically significant. Stress was not associated with 6-month weight change via dietary intake. Baseline stress was positively associated with 6-month depressive symptoms which in turn was associated with less weight change. Depressive symptoms may offer an additional psychosocial target to consider when designing behavioral weight loss interventions for Black women.",2021,Baseline stress was not directly associated with 6-month weight change nor was it indirectly associated via depressive symptoms in the adjusted model.,"['Black women participating in a behavioral weight loss study', 'Black women']",[],"['weight loss', 'Demographics, anthropometry, surveys, and dietary data', 'weight change', '6-month weight change via dietary intake', '6-month depressive symptoms', 'Depressive symptoms']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.109104,Baseline stress was not directly associated with 6-month weight change nor was it indirectly associated via depressive symptoms in the adjusted model.,"[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Molina', 'Affiliation': 'Department of Psychological Sciences, University of California Irvine, Irvine, CA, USA.'}, {'ForeName': 'Monica L', 'Initials': 'ML', 'LastName': 'Baskin', 'Affiliation': 'School of Medicine, Department of Medicine, Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Long', 'Affiliation': 'School of Public Health, Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Carson', 'Affiliation': 'Department of Health Outcomes and Behavior, Division of Population Sciences, H. Lee Moffitt Cancer Center & Research Institute, MFC-EDU, 12902 Magnolia Drive, Tampa, FL, 33612, USA. tiffany.carson@moffitt.org.'}]",Journal of behavioral medicine,['10.1007/s10865-021-00231-z']
781,33999414,Evidence for the additive effects of dispositional negative mood regulation expectancies and placebo-induced expectancies on mood recovery.,"OBJECTIVE


Low negative mood regulation expectancies (NMRE) are associated with greater anticipated and experienced negative mood states, as well as with coping strategies that prolong these states. Individuals with low NMRE may be especially responsive to placebos because confidence in an external source of mood improvement can provide the positive mood expectancies and motivation for active coping that they typically lack. This study investigated how NMRE and placebo-induced expectancies contribute to mood recovery.
METHOD


Participants (N = 125) completed personality scales, including NMRE, online. During a subsequent in-person session, participants were randomly assigned to one of three conditions: (1) placebo treatment-participants learned of a mood-enhancing treatment and received it; (2) treatment deprivation-participants learned of the same treatment, but did not receive it; (3) control-treatment was never mentioned. Participants also completed measures of mood, active coping, and expectations.
RESULTS


NMRE was a stronger predictor of mood recovery than placebo-induced expectancies regardless of group assignment. Additionally, pessimistic expectations arose when participants believed treatment was being deprived, and these participants exhibited the least active coping.
CONCLUSION


Our results confirm the reliability of NMRE in predicting affective outcomes and suggest that personality and placebo-induced expectations have additive effects on mood recovery.",2021,"Additionally, pessimistic expectations arose when participants believed treatment was being deprived, and these participants exhibited the least active coping.
","['Participants (N = 125) completed personality scales, including NMRE, online']","['NMRE and placebo', 'Placebo', 'placebo', 'placebo treatment - participants learned of a mood-enhancing treatment and received it; (2) treatment deprivation - participants learned of the same treatment, but did not receive it; (3) control - treatment']","['Mood Recovery', 'mood, active coping, and expectations', 'mood recovery']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",125.0,0.14603,"Additionally, pessimistic expectations arose when participants believed treatment was being deprived, and these participants exhibited the least active coping.
","[{'ForeName': 'Veronika S', 'Initials': 'VS', 'LastName': 'Bailey', 'Affiliation': 'Department of Psychiatry, BronxCare Health System, Bronx, NY, USA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Brown', 'Affiliation': 'Department of Psychology, Arcadia University, Glenside, PA, USA.'}]",Journal of personality,['10.1111/jopy.12646']
782,34009274,Blood PD-1+TFh and CTLA-4+CD4+ T cells predict remission after CTLA-4Ig treatment in early rheumatoid arthritis.,"OBJECTIVE


Treatment with CTLA-4Ig blocks T-cell activation and is clinically effective in RA. However, it is unknown if specific CD4+ T-cell subsets in blood at baseline predict remission after CTLA-4Ig, or other biological treatments with different modes of action, and how treatment affects CD4+ T cells in patients with untreated early RA (eRA).
METHODS


This study included 60 patients with untreated eRA from a larger randomized trial. They were treated with methotrexate combined with CTLA-4Ig (abatacept, n = 17), anti-IL6 receptor (tocilizumab, n = 21) or anti-TNF (certolizumab-pegol, n = 22). Disease activity was assessed by clinical disease activity index (CDAI), DAS28, swollen joint counts, tender joint counts, CRP and ESR. The primary outcome was CDAI remission (CDAI ≤ 2.8) at week 24. Proportions of 12 CD4+ T-cell subsets were measured by flow cytometry at baseline and after 4, 12 and 24 weeks of treatment.
RESULTS


In patients treated with CTLA-4Ig, the proportions of PD-1+TFh and CTLA-4+ conventional CD4+ T cells at baseline predicted CDAI remission at week 24. CD4+ T-cell subset proportions could not predict remission after treatment with anti-IL6R or anti-TNF. The percentage of regulatory T cells (Tregs) expressing CTLA-4 decreased in all treatment arms by 24 weeks, but only CTLA-4Ig treatment significantly reduced the proportions of Tregs and PD-1+T follicular helper (TFh) cells.
CONCLUSION


These findings indicate that circulating proportions PD-1+TFh and CTLA-4+ conventional CD4+ T cells at baseline may serve as predictive biomarkers for remission in early RA after CTLA-4Ig treatment.",2022,CD4+ T cell subset proportions could not predict remission after treatment with anti-IL6R or anti-TNF.,"['patients with untreated early RA (eRA', 'early rheumatoid arthritis', '60 patients with untreated eRA from a larger randomised trial']","['CTLA-4Ig blocks T cell activation', 'Blood PD-1+TFh and CTLA-4+CD4+ T cells', 'methotrexate combined with CTLA-4Ig (abatacept, n\u2009=\u200917), anti-IL6 receptor (tocilizumab, n\u2009=\u200921) or anti-TNF (certolizumab-pegol, n\u2009=\u200922']","['CD4+ T cells', 'proportions of Tregs and PD-1+T follicular helper (TFh) cells', 'Disease activity', 'CDAI remission', 'percentage of regulatory T cells (Tregs) expressing CTLA-4', 'clinical disease activity index (CDAI), DAS28, swollen joint counts, tender joint counts, CRP and ESR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1619966', 'cui_str': 'abatacept'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}]","[{'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0111208', 'cui_str': 'Cytotoxic T-Lymphocyte Antigen 4'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}]",60.0,0.337099,CD4+ T cell subset proportions could not predict remission after treatment with anti-IL6R or anti-TNF.,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Aldridge', 'Affiliation': 'Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Andersson', 'Affiliation': 'Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Gjertsson', 'Affiliation': 'Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg.'}, {'ForeName': 'Anna-Karin', 'Initials': 'AK', 'LastName': 'Hultgård Ekwall', 'Affiliation': 'Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Hallström', 'Affiliation': 'Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'van Vollenhoven', 'Affiliation': 'Department of Medicine, Rheumatology Unit, Center for Molecular Medicine, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anna-Carin', 'Initials': 'AC', 'LastName': 'Lundell', 'Affiliation': 'Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rudin', 'Affiliation': 'Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keab454']
783,34017999,"Impact of Oral Metronidazole, Vancomycin, and Fidaxomicin on Host Shedding and Environmental Contamination With Clostridioides difficile.","BACKGROUND


Shedding of Clostridioides difficile spores from infected individuals contaminates the hospital environment and contributes to infection transmission. We assessed whether antibiotic selection affects C. difficile shedding and contamination of the hospital environment.
METHODS


In this prospective, unblinded, randomized controlled trial of hospitalized adults with C. difficile infection, patients were randomized 1:1:1 to receive fidaxomicin, oral vancomycin, or metronidazole. The primary outcome was change in environmental contamination rate during treatment. Secondary outcomes included stool shedding, total burden of contamination, and molecular relatedness of stool versus environmental C. difficile isolates.
RESULTS


Of 33 patients enrolled, 31 (94%) completed the study. Fidaxomicin (-0.36 log10 colony-forming units [CFUs]/d [95% confidence interval (CI), -.52 to -.19]; P < .01) and vancomycin (-0.17 log10 CFUs/d [-.34 to -.01]; P = .05) were associated with more rapid decline in C. difficile shedding than metronidazole (-0.01 log10 CFUs/d [95% CI, -.10 to .08). Both vancomycin (6.3% [95% CI, 4.7-8.3) and fidaxomicin (13.1% [10.7-15.9]) were associated with lower rates of environmental contamination than metronidazole (21.4% [18.0-25.2]). With specific modeling of within-subject change over time, fidaxomicin (adjusted odds ratio, 0.83 [95% CI, .70-.99]; P = .04) was associated with more rapid decline in environmental contamination than vancomycin or metronidazole. Overall, 207 of 233 environmental C. difficile isolates (88.8%) matched patient stool isolates by ribotyping, without significant difference by treatment.
CONCLUSIONS


Fidaxomicin, and to a lesser extent vancomycin, reduces C. difficile shedding and contamination of the hospital environment relative to metronidazole. Treatment choice may play a role in reducing healthcare-associated C. difficile transmission.
CLINICAL TRIALS REGISTRATION


NCT02057198.",2022,"Fidaxomicin (-0.36 log10 CFU/day, 95% CI -0.52 to -0.19, p<0.01) and vancomycin (-0.17 log10 CFU/day, 95% CI -0.34 to -0.01, p=0.05) were associated with more rapid decline in C. difficile shedding compared to metronidazole (-0.01 log10 CFU/day, 95% CI -0.10 to +0.08).","['33 patients were enrolled and 31 (94%) completed the study', 'hospitalized adults with C. difficile infection, subjects']","['Oral Metronidazole, Vancomycin, and Fidaxomicin', 'metronidazole', 'vancomycin', 'vancomycin or metronidazole', 'fidaxomicin, oral vancomycin, or metronidazole', 'fidaxomicin ', 'Fidaxomicin']","['rates of environmental contamination', 'fidaxomicin', 'environmental contamination rate', 'stool shedding, total burden of contamination, and molecular relatedness of stool versus environmental C. difficile isolates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0360345', 'cui_str': 'Metronidazole-containing product in oral dose form'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0065023', 'cui_str': 'fidaxomicin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0360373', 'cui_str': 'Vancomycin-containing product in oral dose form'}]","[{'cui': 'C0014419', 'cui_str': 'Environmental pollution'}, {'cui': 'C0065023', 'cui_str': 'fidaxomicin'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}]",33.0,0.332972,"Fidaxomicin (-0.36 log10 CFU/day, 95% CI -0.52 to -0.19, p<0.01) and vancomycin (-0.17 log10 CFU/day, 95% CI -0.34 to -0.01, p=0.05) were associated with more rapid decline in C. difficile shedding compared to metronidazole (-0.01 log10 CFU/day, 95% CI -0.10 to +0.08).","[{'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Turner', 'Affiliation': 'Duke University School of Medicine, Division of Infectious Diseases, Durham, North Carolina, USA.'}, {'ForeName': 'Bobby G', 'Initials': 'BG', 'LastName': 'Warren', 'Affiliation': 'Duke University School of Medicine, Division of Infectious Diseases, Durham, North Carolina, USA.'}, {'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Gergen-Teague', 'Affiliation': 'Division of Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Addison', 'Affiliation': 'Duke University School of Medicine, Division of Infectious Diseases, Durham, North Carolina, USA.'}, {'ForeName': 'Bechtler', 'Initials': 'B', 'LastName': 'Addison', 'Affiliation': 'Duke University School of Medicine, Division of Infectious Diseases, Durham, North Carolina, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Rutala', 'Affiliation': 'Division of Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Weber', 'Affiliation': 'Division of Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Sexton', 'Affiliation': 'Duke University School of Medicine, Division of Infectious Diseases, Durham, North Carolina, USA.'}, {'ForeName': 'Deverick J', 'Initials': 'DJ', 'LastName': 'Anderson', 'Affiliation': 'Duke University School of Medicine, Division of Infectious Diseases, Durham, North Carolina, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciab473']
784,34004347,The Effect of Literacy-Adapted Psychosocial Treatments on Biomedical and Biopsychosocial Pain Conceptualization.,"This is a secondary data analysis of a subgroup of participants who received the Learning About My Pain (LAMP) intervention (clinicaltrials.gov identifier NCT01967342). We examined the effects of LAMP on pre-to-post changes in biomedical and biopsychosocial pain conceptualization and whether those changes in pain conceptualization were associated with physical and psychological functioning. Participants were randomized into three conditions: Cognitive Behavioral Therapy (CBT), Pain Psychoeducation (EDU), or Usual Medical Care (UC). Results based on 225 participants who completed the Pain Concepts Questionnaire (PCQ) showed a pre-to-post reduction in biomedical pain conceptualization (BM), an increase in biopsychosocial pain conceptualization (BPS), and an increase in BPS/BM ratio for CBT and EDU but not UC. There were no differences between CBT and EDU in post-treatment PCQ scores. Compared to those with lower BM pain beliefs scores at post-treatment, participants endorsing higher BM pain beliefs scores reported greater pain intensity and greater pain interference. Furthermore, higher BM pain beliefs scores at post-treatment and lower BPS/BM ratio were associated with higher levels of pain catastrophizing. Overall, results of this study suggest the need for targeting specific pain beliefs that influence pain-related outcomes. PERSPECTIVE: This article presents the potential benefits of providing literacy-adapted psychosocial treatments to expand pain conceptualization beyond a biomedical-only understanding and toward a biopsychosocial conceptualization of the experience of pain. Furthermore, the association of changes in pain conceptualization and pain-related functioning argues for its potential clinical relevance.",2021,There were no differences between CBT and EDU in post-treatment PCQ scores.,['225 participants who completed the'],"['Learning About My Pain (LAMP) interventions', 'Cognitive Behavioral Therapy (CBT), Pain Psychoeducation (EDU), or Usual Medical Care (UC', 'LAMP', 'Literacy-Adapted Psychosocial Treatments']","['Pain Concepts Questionnaire (PCQ', 'higher BM pain beliefs scores', 'BPS/BM ratio', 'Biomedical and Biopsychosocial Pain Conceptualization', 'BM pain beliefs scores', 'biopsychosocial pain conceptualization (BPS', 'pain intensity and greater pain interference', 'pain catastrophizing']","[{'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0589138', 'cui_str': 'Conceptualization'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}]",225.0,0.183092,There were no differences between CBT and EDU in post-treatment PCQ scores.,"[{'ForeName': 'Calia A', 'Initials': 'CA', 'LastName': 'Morais', 'Affiliation': 'Pain Research and Intervention Center of Excellence (PRICE), Department of Community Dentistry and Behavioral Sciences, College of Dentistry, University of Florida, Gainesville, Florida; Center for Pain Research and Behavioral Health, Department of Clinical and Health Psychology, University of Florida, Florida. Electronic address: cmorais@dental.ufl.edu.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Newman', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Van Dyke', 'Affiliation': 'Department of Psychology, Young Harris College, Young Harris, Georgia.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Thorn', 'Affiliation': 'Department of Psychology, The University of Alabama, Tuscaloosa, Alabama.'}]",The journal of pain,['10.1016/j.jpain.2021.04.005']
785,34021314,"Sensitivity, Specificity, and Safety of a Novel ESAT6-CFP10 Skin Test for Tuberculosis Infection in China: 2 Randomized, Self-Controlled, Parallel-Group Phase 2b Trials.","BACKGROUND


Diagnostics to identify tuberculosis infection are limited. We aimed to assess the diagnostic accuracy and safety of ESAT6-CFP10 (EC) skin test for tuberculosis infection in Chinese adults.
METHODS


We conducted 2 randomized, parallel-group clinical trials in healthy participants and tuberculosis patients. All participants were tested with the T-SPOT.TB test, then received an EC skin test and tuberculin skin test (TST). The diameter of skin indurations and/or redness at injection sites were measured at different time periods. A bacillus Calmette Guerin (BCG) model was established to assess the diagnosis of tuberculosis infection using an EC skin test.
RESULTS


In total, 777 healthy participants and 96 tuberculosis patients were allocated to receive EC skin test at 1.0 μg/0.1 mL or 0.5 μg/0.1 mL. The area under the curve was 0.95 (95% confidence interval [CI], .91-.97) for the EC skin test at 1.0 μg/0.1 mL at 24-72 hours. Compared with the T-SPOT.TB test, the EC skin test demonstrated similar sensitivity (87.5, 95% CI, 77.8-97.2 vs 86.5, 95% CI, 79.5-93.4) and specificity (98.9, 95% CI, 96.0-99.9 vs 96.1, 95% CI, 93.5-97.8). Among BCG vaccinated participants, the EC skin test had high consistency with the T-SPOT.TB test (96.3, 95% CI, 92.0-100.0). No serious adverse events related to the EC skin test were observed.
CONCLUSIONS


The EC skin test demonstrated both high specificity and sensitivity at a dose of 1.0 μg/0.1 mL, comparable to the T-SPOT.TB test. The diagnostic accuracy of the EC skin test was not impacted by BCG vaccination.
CLINICAL TRIALS REGISTRATION


NCT02389322 and NCT02336542.",2022,"The EC skin test demonstrated both high specificity and sensitivity at a dose of 1.0μg/0.1ml, comparable to the T-SPOT.TB test.","['healthy participants and tuberculosis patients', 'tuberculosis infection in Chinese adults', 'tuberculosis infection in China', '777 healthy participants and 96 tuberculosis patients']","['novel ESAT6-CFP10 skin test', 'EC skin test and tuberculin skin test (TST', 'novel ESAT6-CFP10 (EC) skin test']","['diameter of skin indurations and/or redness at injection sites', 'specificity', 'sensitivity', 'Sensitivity, specificity, and safety']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037296', 'cui_str': 'Hypersensitivity skin testing'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0241075', 'cui_str': 'Induration of skin'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",777.0,0.323857,"The EC skin test demonstrated both high specificity and sensitivity at a dose of 1.0μg/0.1ml, comparable to the T-SPOT.TB test.","[{'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, PR China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Center for Disease Control and Prevention of Jiangsu Province, Nanjing, Jiangsu Province, PR China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Shanghai Public Health Clinical Center, Fudan University, Shanghai, PR China.'}, {'ForeName': 'Jingxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Center for Disease Control and Prevention of Jiangsu Province, Nanjing, Jiangsu Province, PR China.'}, {'ForeName': 'Weixin', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, PR China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Tianjin Haihe Hospital, Tianjin University, Tianjin, PR China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Center for Disease Control and Prevention of Jiangsu Province, Nanjing, Jiangsu Province, PR China.'}, {'ForeName': 'Baodong', 'Initials': 'B', 'LastName': 'Yuan', 'Affiliation': 'Wuhan Pulmonary Hospital, Wuhan, Hubei Province, PR China.'}, {'ForeName': 'Jinbiao', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, PR China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Center for Disease Control and Prevention of Jiangsu Province, Nanjing, Jiangsu Province, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Shanghai Public Health Clinical Center, Fudan University, Shanghai, PR China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Center for Disease Control and Prevention of Jurong city, Zhenjiang, Jiangsu Province, PR China.'}, {'ForeName': 'Baowen', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, PR China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Pu', 'Affiliation': 'Anhui Zhifei Longcom Biopharmaceutical Co, Ltd, Hefei, Anhui Province, PR China.'}, {'ForeName': 'Rongping', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Center for Disease Control and Prevention of Jurong city, Zhenjiang, Jiangsu Province, PR China.'}, {'ForeName': 'Xiuhong', 'Initials': 'X', 'LastName': 'Xi', 'Affiliation': 'Shanghai Public Health Clinical Center, Fudan University, Shanghai, PR China.'}, {'ForeName': 'Rongguang', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Center for Disease Control and Prevention of Jurong city, Zhenjiang, Jiangsu Province, PR China.'}, {'ForeName': 'Zaoxian', 'Initials': 'Z', 'LastName': 'Mei', 'Affiliation': 'Tianjin Haihe Hospital, Tianjin University, Tianjin, PR China.'}, {'ForeName': 'Ronghui', 'Initials': 'R', 'LastName': 'Du', 'Affiliation': 'Wuhan Pulmonary Hospital, Wuhan, Hubei Province, PR China.'}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Anhui Zhifei Longcom Biopharmaceutical Co, Ltd, Hefei, Anhui Province, PR China.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Martinez', 'Affiliation': 'Boston University, School of Public Health, Department of Epidemiology, Boston, Massachusetts, USA.'}, {'ForeName': 'Shuihua', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Public Health Clinical Center, Fudan University, Shanghai, PR China.'}, {'ForeName': 'Guozhi', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, PR China.'}, {'ForeName': 'Fengcai', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Center for Disease Control and Prevention of Jiangsu Province, Nanjing, Jiangsu Province, PR China.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciab472']
786,34015952,Characteristics of Enrollees in the Supported Employment Demonstration.,"OBJECTIVE


The Supported Employment Demonstration (SED), a multiyear (2016-2022), randomized controlled trial funded by the Social Security Administration, recruited a nontraditional sample of benefits applicants with self-reported or documented mental health conditions who were denied disability benefits and who expressed a desire for employment. This study describes the characteristics of the SED sample at baseline.
METHODS


The authors analyzed baseline data from the 2,960 eligible enrollees, including responses to the Composite International Diagnostic Interview, the 12-item Short-Form Health Survey (SF-12), and the Work Disability Functional Assessment Battery (WD-FAB).
RESULTS


A majority of SED enrollees self-identified as female (57%), White (56%), and non-Hispanic (87%). Many were 35 years or older (58%), reported at least a high school education (81%), lived with relatives (69%), had never married (55%), were unemployed (81%), and were poor. Median monthly household income was $1,200. Anxiety disorders (71%), personality disorders (65%), and mood disorders (61%) were prevalent. Enrollees reported a mean±SD of 2.5±1.3 mental health conditions and 3.5±2.1 general medical conditions. Health-related quality of life was low, relative to national norms: mean scores for the sample were 32.6±12.5 on the SF-12 mental component summary and 38.3±13.0 on the physical component summary. Mean scores on the WD-FAB subdomains were more than a SD below norms.
CONCLUSIONS


At baseline, the SED sample had multiple mental health and general medical conditions, low quality of life, and low functional ability. Despite these challenges, the ongoing SED intervention seeks to build on enrollees' expressed desire for employment.",2021,"Health-related quality of life was low, relative to national norms: mean scores for the sample were 32.6±12.5 on the SF-12 mental component summary and 38.3±13.0 on the physical component summary.","['Many were 35 years or older (58%), reported at least a high school education (81%), lived with relatives (69%), had never married (55%), were unemployed (81%), and were poor', 'A majority of SED enrollees self-identified as female (57%), White (56%), and non-Hispanic (87', '2,960 eligible enrollees, including responses to the Composite International Diagnostic Interview, the 12-item Short-Form Health Survey (SF-12), and the Work Disability Functional Assessment Battery (WD-FAB', 'multiyear (2016-2022), randomized controlled trial funded by the Social Security Administration, recruited a nontraditional sample of benefits applicants with self-reported or documented mental health conditions who were denied disability benefits and who expressed a desire for employment']",[],"['Anxiety disorders', 'Mean scores', 'multiple mental health and general medical conditions, low quality of life, and low functional ability', 'Health-related quality of life', 'mood disorders', 'personality disorders']","[{'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0578839', 'cui_str': 'Lives with relatives'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0451085', 'cui_str': 'Composite international diagnostic interview'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0282680', 'cui_str': 'Social Security Administration, United States'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332319', 'cui_str': 'Denied'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}]",[],"[{'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0031212', 'cui_str': 'Personality disorder'}]",2960.0,0.175892,"Health-related quality of life was low, relative to national norms: mean scores for the sample were 32.6±12.5 on the SF-12 mental component summary and 38.3±13.0 on the physical component summary.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Borger', 'Affiliation': 'Westat, Rockville, Maryland.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Marrow', 'Affiliation': 'Westat, Rockville, Maryland.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Drake', 'Affiliation': 'Westat, Rockville, Maryland.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Westat, Rockville, Maryland.'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.202000826']
787,34020312,Evaluating potential mediators for the impact of a family-based economic intervention (Suubi+Adherence) on the mental health of adolescents living with HIV in Uganda.,"INTRODUCTION


Many adolescents living with HIV in sub-Saharan Africa (SSA) experience poverty and have access to limited resources, which can impact HIV and mental health outcomes. Few studies have analyzed the impact of economic empowerment interventions on the psychosocial wellbeing of adolescents living with HIV in low resource communities, and this study aims to examine the mediating mechanism(s) that may explain the relationship between a family economic empowerment intervention (Suubi + Adherence) and mental health outcomes for adolescents (ages 10-16 at enrollment) living with HIV in Uganda.
METHOD


We utilized data from Suubi + Adherence, a large-scale six-year (2012-2018) longitudinal randomized controlled trial (N = 702). Generalized structural equation models (GSEMs) were conducted to examine 6 potential mediators (HIV viral suppression, food security, family assets, and employment, HIV stigma, HIV status disclosure comfort level, and family cohesion) to determine those that may have driven the effects of the Suubi + Adherence intervention on adolescents' mental health.
RESULTS


Family assets and employment were the only statistically significant mediators during follow-up (β from -0.03 to -0.06), indicating that the intervention improved family assets and employment which, in turn, was associated with improved mental health. The proportion of the total effect mediated by family assets and employment was from 42.26% to 71.94%.
CONCLUSIONS


Given that mental health services provision is inadequate in SSA, effective interventions incorporating components related to family assets, employment, and financial stability are crucial to supporting the mental health needs of adolescents living with HIV in under-resourced countries like Uganda. Future research should work to develop the sustainability of such interventions to improve long-term mental health outcomes among this at-risk group.",2021,"Few studies have analyzed the impact of economic empowerment interventions on the psychosocial wellbeing of adolescents living with HIV in low resource communities, and this study aims to examine the mediating mechanism(s) that may explain the relationship between a family economic empowerment intervention (Suubi + Adherence) and mental health outcomes for adolescents (ages 10-16 at enrollment) living with HIV in Uganda.
","['adolescents living with HIV in under-resourced countries like Uganda', 'adolescents living with HIV in low resource communities', 'adolescents (ages 10-16\xa0at enrollment) living with HIV in Uganda', 'adolescents living with HIV in Uganda', 'adolescents living with HIV in sub-Saharan Africa (SSA) experience poverty', ""adolescents' mental health""]","['family-based economic intervention (Suubi+Adherence', 'economic empowerment interventions', 'Suubi\xa0+\xa0Adherence intervention', 'Generalized structural equation models (GSEMs']","['mental health', 'potential mediators (HIV viral suppression, food security, family assets, and employment, HIV stigma, HIV status disclosure comfort level, and family cohesion']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}]",,0.108468,"Few studies have analyzed the impact of economic empowerment interventions on the psychosocial wellbeing of adolescents living with HIV in low resource communities, and this study aims to examine the mediating mechanism(s) that may explain the relationship between a family economic empowerment intervention (Suubi + Adherence) and mental health outcomes for adolescents (ages 10-16 at enrollment) living with HIV in Uganda.
","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Cavazos-Rehg', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, 660 South Euclid Avenue, Box 8134, St. Louis, MO, 63110, USA. Electronic address: pcavazos@wustl.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Doroshenko', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, 660 South Euclid Avenue, Box 8134, St. Louis, MO, 63110, USA.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'University of California, San Francisco, School of Medicine, 533 Parnassus Ave, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Nnenna', 'Initials': 'N', 'LastName': 'Anako', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, 660 South Euclid Avenue, Box 8134, St. Louis, MO, 63110, USA; Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Kasson', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, 660 South Euclid Avenue, Box 8134, St. Louis, MO, 63110, USA.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Claude A', 'Initials': 'CA', 'LastName': 'Mellins', 'Affiliation': 'Columbia University, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, St. Louis, MO, 63130, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2021.113946']
788,34021031,Nephrologist Follow-Up versus Usual Care after an Acute Kidney Injury Hospitalization (FUSION): A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


Survivors of AKI are at higher risk of CKD and death, but few patients see a nephrologist after hospital discharge. Our objectives during this 2-year vanguard phase trial were to determine the feasibility of randomizing survivors of AKI to early follow-up with a nephrologist or usual care, and to collect data on care processes and outcomes.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


We performed a randomized controlled trial in patients hospitalized with Kidney Disease Improving Global Outcomes (KDIGO) stage 2-3 AKI at four hospitals in Toronto, Canada. We randomized patients to early nephrologist follow-up (standardized basket of care that emphasized BP control, cardiovascular risk reduction, and medication safety) or usual care from July 2015 to June 2017. Feasibility outcomes included the proportion of eligible patients enrolled, seen by a nephrologist, and followed to 1 year. The primary clinical outcome was a major adverse kidney event at 1 year, defined as death, maintenance dialysis, or incident/progressive CKD.
RESULTS


We screened 3687 participants from July 2015 to June 2017, of whom 269 were eligible. We randomized 71 (26%) patients (34 to nephrology follow-up and 37 to usual care). The primary reason stated for declining enrollment included hospitalization-related fatigue ( n =65), reluctance to add more doctors to the health care team ( n =59), and long travel times ( n =40). Nephrologist visits occurred in 24 of 34 (71%) intervention participants, compared with three of 37 (8%) participants randomized to usual care. The primary clinical outcome occurred in 15 of 34 (44%) patients in the nephrologist follow-up arm, and 16 of 37 (43%) patients in the usual care arm (relative risk, 1.02; 95% confidence interval, 0.60 to 1.73).
CONCLUSIONS


Major adverse kidney events are common in AKI survivors, but we found the in-person model of follow-up posed a variety of barriers that was not acceptable to many patients.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Nephrologist Follow-up versus Usual Care after an Acute Kidney Injury Hospitalization (FUSION), NCT02483039 CJASN 16: 1005-1014, 2021. doi: https://doi.org/10.2215/CJN.17331120.",2021,"The primary clinical outcome occurred in 15/34 (44%) patients in the nephrologist follow-up arm and 16/37 (43%) patients in the usual care arm (relative risk=1.02, 95% CI 0.60-1.73).
","['n=65), reluctance to add more doctors to the healthcare team (n=59), and long travel times (n=40', 'Survivors of acute kidney injury (AKI', '3687 participants from July 2015 to June 2017, of whom 269 were eligible', 'patients hospitalized with Kidney Disease Improving Global Outcomes (KDIGO) stage 2-3 AKI at 4 hospitals in Toronto, Canada']",['Nephrologist Follow-Up versus Usual Care'],"['hospitalization-related fatigue', 'Nephrologist visits', 'major adverse kidney event at 1-year, defined as death, maintenance dialysis, or incident/progressive chronic kidney disease']","[{'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0086390', 'cui_str': 'Health Care Team'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0260039', 'cui_str': 'Nephrologist'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0260039', 'cui_str': 'Nephrologist'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]",71.0,0.167884,"The primary clinical outcome occurred in 15/34 (44%) patients in the nephrologist follow-up arm and 16/37 (43%) patients in the usual care arm (relative risk=1.02, 95% CI 0.60-1.73).
","[{'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Silver', 'Affiliation': ""Division of Nephrology, Kingston Health Sciences Centre, Queen's University, Kingston, Ontario, Canada, samuel.silver@queensu.ca.""}, {'ForeName': 'Neill K', 'Initials': 'NK', 'LastName': 'Adhikari', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Chaim M', 'Initials': 'CM', 'LastName': 'Bell', 'Affiliation': 'Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Chan', 'Affiliation': 'Division of Nephrology, University Health Network-Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Harel', 'Affiliation': ""Division of Nephrology and Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Abhijat', 'Initials': 'A', 'LastName': 'Kitchlu', 'Affiliation': 'Division of Nephrology, University Health Network-Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Meraz-Muñoz', 'Affiliation': ""Division of Nephrology and Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Norman', 'Affiliation': 'Kingston General Health Research Institute, Kingston, Ontario, Canada.'}, {'ForeName': 'Adic', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Zahirieh', 'Affiliation': 'Division of Nephrology, Sunnybrook Health Sciences Centre, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Wald', 'Affiliation': ""Division of Nephrology and Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.17331120']
789,34021094,Continuous Versus Intermittent Running: Acute Performance Decrement and Training Load.,"PURPOSE


To examine the effect of continuous (CON) and intermittent (INT) running training sessions of different durations and intensities on subsequent performance and calculated training load (TL).
METHODS


Runners (N = 11) performed a 1500-m time trial as a baseline and after completing 4 different running training sessions. The training sessions were performed in a randomized order and were either maximal for 10 minutes (10CON and 10INT) or submaximal for 25 minutes (25CON and 25INT). An acute performance decrement (APD) was calculated as the percentage change in 1500-m time-trial speed measured after training compared with baseline. The pattern of APD response was compared with that for several TL metrics (bTRIMP, eTRIMP, iTRIMP, running training stress score, and session rating of perceived exertion) for the respective training sessions.
RESULTS


Average speed (P < .001, ηp2=.924) was different for each of the initial training sessions, which all resulted in a significant APD. This APD was similar when compared across the sessions except for a greater APD found after 10INT versus 25CON (P = .02). In contrast, most TL metrics were different and showed the opposite response to APD, being higher for CON versus INT and lower for 10- versus 25-minute sessions (P < .001, ηp2>.563).
CONCLUSION


An APD was observed consistently after running training sessions, but it was not consistent with most of the calculated TL metrics. The lack of agreement found between APD and TL suggests that current methods for quantifying TL are flawed when used to compare CON and INT running training sessions of different durations and intensities.",2021,"RESULTS


Average speed (P < .001, ηp2=.924) was different for each of the initial training sessions, which all resulted in a significant APD.",['Runners (N = 11'],"['continuous (CON) and intermittent (INT) running training sessions', 'Continuous Versus Intermittent Running', 'maximal for 10\xa0minutes (10CON and 10INT) or submaximal for 25\xa0minutes (25CON and 25INT']","['several TL metrics (bTRIMP, eTRIMP, iTRIMP, running training stress score, and session rating of perceived exertion', 'acute performance decrement (APD', 'Acute Performance Decrement and Training Load']",[],"[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.0124097,"RESULTS


Average speed (P < .001, ηp2=.924) was different for each of the initial training sessions, which all resulted in a significant APD.","[{'ForeName': 'Antonis', 'Initials': 'A', 'LastName': 'Kesisoglou', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Nicolò', 'Affiliation': ''}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Howland', 'Affiliation': ''}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Passfield', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0844']
790,34021092,Limiting Rise in Heat Load With an Ice Vest During Elite Female Rugby Sevens Warm-Ups.,"PURPOSE


To determine the effect of wearing a phase-change cooling vest in elite female rugby sevens athletes during (1) a simulated match-day warm-up in hot conditions prior to a training session and (2) a prematch warm-up during a tournament in cool conditions.
METHODS


This study consisted of 2 randomized independent group designs (separated by 16 d) where athletes completed the same 23- to 25-minute match-day warm-up (1) in hot conditions (range = 28.0°C to 35.1°C wet bulb globe temperature [WBGT]) prior to training and (2) in cool conditions (range = 18.8°C to 20.1°C WBGT) prior to a World Rugby Women's Sevens Series match. In both conditions, athletes were randomly assigned to wearing either (1) the standardized training/playing ensemble (synthetic rugby shorts and training tee/jersey) or (2) the standardized training/playing ensemble plus a commercial phase-change athletic cooling vest. Group-wise differences in core temperature rise from baseline, global positioning system-measured external locomotive output, and perceptual thermal load were compared.
RESULTS


Core temperature rise during a match warm-up was lower in the hot condition only (-0.65°C [95% confidence interval = -1.22°C to -0.08°C], ηp2=.23 [95% confidence interval = .00 to .51], P = .028). No differences in various external-load variables were observed.
CONCLUSIONS


Phase-change cooling vests can be worn by athletes prior to, and during, a prematch warm-up in hot conditions to limit excess core temperature rise without adverse effects on thermal perceptions or external locomotion output.",2021,"RESULTS


Core temperature rise during a match warm-up was lower in the hot condition only (-0.65°C [95% confidence interval = -1.22°C to -0.08",['elite female rugby sevens athletes'],"[""athletes completed the same 23- to 25-minute match-day warm-up (1)\xa0in hot conditions (range = 28.0°C to 35.1°C wet bulb globe temperature [WBGT]) prior to training and (2)\xa0in cool conditions (range = 18.8°C to 20.1°C WBGT) prior to a World Rugby Women's Sevens Series match"", 'wearing either (1)\xa0the standardized training/playing ensemble (synthetic rugby shorts and training tee/jersey) or (2)\xa0the standardized training/playing ensemble plus a commercial phase-change athletic cooling vest', 'wearing a phase-change cooling vest', 'Ice Vest']","['global positioning system-measured external locomotive output, and perceptual thermal load']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0025148', 'cui_str': 'Medulla oblongata structure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0454673', 'cui_str': 'Jersey'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C0020746', 'cui_str': 'Ice'}]","[{'cui': 'C2350032', 'cui_str': 'Global Positioning System'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}]",,0.0952028,"RESULTS


Core temperature rise during a match warm-up was lower in the hot condition only (-0.65°C [95% confidence interval = -1.22°C to -0.08","[{'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Henderson', 'Affiliation': ''}, {'ForeName': 'Bryna C R', 'Initials': 'BCR', 'LastName': 'Chrismas', 'Affiliation': ''}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'Fransen', 'Affiliation': ''}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Coutts', 'Affiliation': ''}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0833']
791,34039769,A Comparison of Training With a Velocity Loss Threshold or to Repetition Failure on Upper-Body Strength Development in Professional Australian Footballers.,"PURPOSE


To compare resistance training using a velocity loss threshold with training to repetition failure on upper-body strength parameters in professional Australian footballers.
METHODS


A total of 26 professional Australian footballers (23.9 [4.2] y, 189.9 [7.8] cm, 88.2 [8.8] kg) tested 1-repetition-maximum strength (FPmax) and mean barbell velocity at 85% of 1-repetition maximum on floor press (FPvel). They were then assigned to 2 training groups: 20% velocity loss threshold training (VL; n = 12, maximum-effort lift velocity) or training to repetition failure (TF; n = 14, self-selected lift velocity). Subjects trained twice per week for 3 weeks before being reassessed on FPmax and FPvel. Training volume (total repetitions) was recorded for all training sessions. No differences were present between groups on any pretraining measure.
RESULTS


The TF group significantly improved FPmax (105.2-110.9 kg, +5.4%), while the VL group did not (107.5-109.2 kg, +1.6%) (P > .05). Both groups significantly increased FPvel (0.38-0.46 m·s-1, +19.1% and 0.37-0.42 m·s-1, +16.7%, respectively) with no between-groups differences evident (P > .05). The TF group performed significantly more training volume (12.2 vs 6.8 repetitions per session, P > .05).
CONCLUSIONS


Training to repetition failure improved FPmax, while training using a velocity loss threshold of 20% did not. Both groups demonstrated similar improvements in FPvel despite the VL group completing 45% less total training volume than the TF group. The reduction in training volume associated with implementing a 20% velocity loss threshold may negatively impact the development of upper-body maximum strength while still enhancing submaximal movement velocity.",2021,Both groups demonstrated similar improvements in FPvel despite the VL group completing 45% less total training volume than the TF group.,"['A total of 26 professional Australian footballers (23.9 [4.2]\xa0y, 189.9 [7.8]\xa0cm, 88.2 [8.8]\xa0kg) tested 1-repetition-maximum strength (FPmax) and mean barbell velocity at 85% of 1-repetition maximum on floor press (FPvel', 'Professional Australian Footballers']","['velocity loss threshold training (VL; n = 12, maximum-effort lift velocity) or training to repetition failure (TF; n = 14, self-selected lift velocity', 'Training With a Velocity Loss Threshold or to Repetition Failure']","['FPvel', 'Training volume (total repetitions', 'training volume', 'total training volume', 'FPmax']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0233742', 'cui_str': 'Repetition failure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",26.0,0.00371943,Both groups demonstrated similar improvements in FPvel despite the VL group completing 45% less total training volume than the TF group.,"[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Kilgallon', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Johnston', 'Affiliation': ''}, {'ForeName': 'Liam P', 'Initials': 'LP', 'LastName': 'Kilduff', 'Affiliation': ''}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Watsford', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0882']
792,34024025,Effects of Gocovri (Amantadine) Extended-Release Capsules on Motor Aspects of Experiences of Daily Living in People with Parkinson's Disease and Dyskinesia.,"INTRODUCTION


Gocovri, a bedtime-administered delayed-release/extended-release capsule formulation of amantadine, is the only drug approved by the US Food and Drug Administration as levodopa-adjunctive therapy for the treatment of OFF episodes and/or dyskinesia in Parkinson's disease (PD). Part II of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assesses patient-perceived disability on experiences of daily living affected by PD motor symptoms. We analyzed Gocovri-related changes in MDS-UPDRS Part II ratings in two placebo-controlled clinical trials.
METHODS


Baseline to week 12 changes in MDS-UPDRS Part II total and item scores were compared for Gocovri and placebo using pooled data from phase 3 trials (EASE LID and EASE LID 3).
RESULTS


Baseline mean MDS-UPDRS Part II total score was 15.1 for Gocovri (n = 100) and 15.3 for placebo (n = 96) groups. At week 12, the least squares mean change from baseline was -3.4 for the Gocovri group and -1.4 for placebo (treatment difference, -2.0; 95% CI -3.3 to -0.7; P = 0.004). For Gocovri, change from baseline exceeded a published minimal clinically important difference threshold of 3.05. Gocovri-related treatment differences over placebo were driven primarily by improvement in the scale items of freezing (-0.4; P < 0.0001), tremor (-0.4; P = 0.002), getting out of bed/car/deep chair (-0.3; P = 0.002), and eating tasks (-0.2; P = 0.016).
CONCLUSION


In addition to improvement in dyskinesia, Gocovri-treated participants experienced improvement in motor aspects of experiences of daily living. Analyses suggest that Gocovri may specifically improve freezing, tremor, getting out of bed/car/deep chair, and eating tasks.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: NCT02136914, NCT02274766.",2021,Baseline mean MDS-UPDRS Part II total score was 15.1 for Gocovri (n = 100) and 15.3 for placebo (n = 96) groups.,"[""OFF episodes and/or dyskinesia in Parkinson's disease (PD"", ""Experiences of Daily Living in People with Parkinson's Disease and Dyskinesia""]","['amantadine', 'Gocovri (Amantadine', 'Gocovri and placebo', 'placebo', 'levodopa-adjunctive therapy']","['motor aspects of experiences of daily living', 'MDS-UPDRS', 'getting out of bed/car/deep chair', 'freezing, tremor, getting out of bed/car/deep chair, and eating tasks', 'Baseline mean MDS-UPDRS Part II total score', 'eating tasks']","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0002403', 'cui_str': 'Amantadine'}, {'cui': 'C4522700', 'cui_str': 'Gocovri'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.350984,Baseline mean MDS-UPDRS Part II total score was 15.1 for Gocovri (n = 100) and 15.3 for placebo (n = 96) groups.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': ""USF Parkinson's Disease and Movement Disorders Center, Parkinson Foundation Center of Excellence, University of South Florida, 4001 E. Fletcher Ave, 6th Floor, Tampa, FL, 33613, USA. rhauser@usf.edu.""}, {'ForeName': 'Shyamal H', 'Initials': 'SH', 'LastName': 'Mehta', 'Affiliation': 'Department of Neurology, Mayo Clinic-Scottsdale, Scottsdale, AZ, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kremens', 'Affiliation': 'Department of Neurology, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Chernick', 'Affiliation': 'Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Formella', 'Affiliation': 'Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.'}]",Neurology and therapy,['10.1007/s40120-021-00256-1']
793,34044481,Modified high-flow nasal cannula for children with respiratory distress.,"BACKGROUND


High-flow nasal cannula (HFNC) is a noninvasive respiratory support that provides the optimum flow of an air-oxygen mixture. Several studies demonstrated its usefulness and good safety profile for treating pediatric respiratory distress patients. However, the cost of the commercial HFNC is high; therefore, the modified high-flow nasal cannula was developed.
PURPOSE


This study aimed to compare the effectiveness, safety, and nurses' satisfaction of the modified system versus the standard commercial HFNC.
METHODS


This prospective comparative study was performed in a tertiary care hospital. We recruited children aged 1 month to 5 years who developed acute respiratory distress and were admitted to the pediatric intensive care unit. Patients were assigned to 2 groups (modified vs. commercial). The effectiveness and safety assessments included vital signs, respiratory scores, intubation rate, adverse events, and nurses' satisfaction.
RESULTS


A total of 74 patients were treated with HFNC. Thirty- nine patients were assigned to the modified group, while the remaining 35 patients were in the commercial group. Intubation rate and adverse events did not differ significantly between the 2 groups. However, the commercial group had higher nurses' satisfaction scores than the modified group.
CONCLUSION


Our findings suggest that our low-cost modified HFNC could be a useful respiratory support option for younger children with acute respiratory distress, especially in hospital settings with financial constraints.",2022,Intubation rate and adverse events did not differ significantly between the two groups.,"['Thirty-nine patients', 'children with respiratory distress', 'younger children with acute respiratory distress', 'children aged 1 month to 5 years who developed acute respiratory distress and were admitted to the pediatric intensive care unit', 'pediatric respiratory distress patients', '74 patients were treated with']","['HFNC', 'Modified high-flow nasal cannula', '\n\n\nHigh-flow nasal cannula (HFNC']","[""effectiveness and safety assessments included vital signs, respiratory scores, intubation rate, adverse events, and nurses' satisfaction"", ""effectiveness, safety, and nurses' satisfaction"", 'Intubation rate and adverse events', ""nurses' satisfaction scores""]","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0748355', 'cui_str': 'Acute respiratory distress'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",74.0,0.0253049,Intubation rate and adverse events did not differ significantly between the two groups.,"[{'ForeName': 'Sarocha', 'Initials': 'S', 'LastName': 'Itdhiamornkulchai', 'Affiliation': 'Division of Pediatric Critical Care Medicine, Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Aroonwan', 'Initials': 'A', 'LastName': 'Preutthipan', 'Affiliation': 'Division of Pediatric Pulmonology, Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Jarin', 'Initials': 'J', 'LastName': 'Vaewpanich', 'Affiliation': 'Division of Pediatric Critical Care Medicine, Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nattachai', 'Initials': 'N', 'LastName': 'Anantasit', 'Affiliation': 'Division of Pediatric Critical Care Medicine, Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Clinical and experimental pediatrics,['10.3345/cep.2020.01403']
794,34044366,Dose-Response Relationship Between Velocity Loss During Resistance Training and Changes in the Squat Force-Velocity Relationship.,"PURPOSE


This study aimed to compare the adaptations provoked by various velocity loss (VL) thresholds used in resistance training on the squat force-velocity (F-V) relationship.
METHODS


Sixty-four resistance-trained young men were randomly assigned to one of four 8-week resistance training programs (all 70%-85% 1-repetition maximum) using different VL thresholds (VL0 = 0%, VL10 = 10%, VL20 = 20%, and VL40 = 40%) in the squat exercise. The F-V relationship was assessed under unloaded and loaded conditions in squat. Linear and hyperbolic (Hill) F-V equations were used to calculate force at zero velocity (F0), velocity at zero force (V0), maximum muscle power (Pmax), and force produced at mean velocities ranging from 0.0 to 2.0 m·s-1. Changes in parameters derived from the F-V relationship were compared among groups using linear mixed models.
RESULTS


Linear equations showed increases in F0 (120.7 N [89.4 to 152.1]) and Pmax (76.2 W [45.3 to 107.2]) and no changes in V0 (-0.02 m·s-1 [-0.11 to 0.06]) regardless of VL. Hyperbolic equations depicted increases in F0 (120.7 N [89.4 to 152.1]), V0 (1.13 m·s-1 [0.78 to 1.48]), and Pmax (198.5 W [160.5 to 236.6]) with changes in V0 being greater in VL0 and VL10 versus VL40 (both P < .001). All groups similarly improved force at 0.0 to 2.0 m·s-1 (all P < .001), although in general, effect sizes were greater in VL10 and VL20 versus VL0 and VL40 at velocities ≤0.5 m·s-1.
CONCLUSIONS


All groups improved linear and hyperbolic F0 and Pmax and hyperbolic V0 (except VL40). The dose-response relationship exhibited an inverted U-shape pattern at velocities ≤0.5 m·s-1 with VL10 and VL20 showing the greatest standardized changes.",2021,The dose-response relationship exhibited an inverted U-shape pattern at velocities ≤0.5 m·s-1 with VL10 and VL20 showing the greatest standardized changes.,['Sixty-four resistance-trained young men'],['squat exercise'],"['calculate force at zero velocity (F0), velocity at zero force (V0), maximum muscle power (Pmax), and force produced at mean velocities', 'VL10 and VL20 versus VL0 and VL40 at velocities ≤0.5', 'linear and hyperbolic F0 and Pmax and hyperbolic V0 (except VL40', 'Velocity Loss', 'F0', 'Linear and hyperbolic (Hill) F-V equations']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",64.0,0.0297932,The dose-response relationship exhibited an inverted U-shape pattern at velocities ≤0.5 m·s-1 with VL10 and VL20 showing the greatest standardized changes.,"[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Alcazar', 'Affiliation': ''}, {'ForeName': 'Pedro J', 'Initials': 'PJ', 'LastName': 'Cornejo-Daza', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Sánchez-Valdepeñas', 'Affiliation': ''}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Alegre', 'Affiliation': ''}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pareja-Blanco', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0692']
795,34043064,Prophylactic administration of diphenhydramine/paracetamol reduced emergence agitation and postoperative pain following maxillofacial surgeries: a randomized controlled trial.,"BACKGROUND


Emergence agitation after maxillofacial surgeries is an anxious and problematic complication for the surgeon and anesthesiologist that may lead to self-extubation, haemorrhage, and surgical destruction. In this study, we investigated the effects of preemptive administration of diphenhydramine on emergence agitation and quality of recovery after maxillofacial surgery in adult patients.
METHODS


Eighty-five patients undergoing maxillofacial surgery were randomized into two groups. The diphenhydramine group (Group D, n = 40) received diphenhydramine premedication 0.5 mg/kg before anesthesia induction, while the control group (Group C, n = 40) received volume-matched normal saline as a placebo. Before incision, all patients receive 0.1 mg/kg morphine sulfate slowly intravenously within 5 min. Continuous infusion of remifentanil 0.2 μg/kg/h and inhalation of isoflurane was maintained during the anesthesia period. Paracetamol 1 g was infused 15 min before extubation. We evaluated the incidence of agitation during the extubation period after general anesthesia, hemodynamic parameters, and recovery characteristics during the postoperative period.
RESULTS


During extubation time, the incidence of emergence agitation was lower in Group D than in Group C (16% vs. 49%, P = 0.041). The time from isoflurane discontinuation to extubation (7.7 min in Group D vs. 6.8 min in Group C, P = 0.082) was not different. Grade of cough during emergence, the severity of pain, analgesic requirements, and hemodynamic changes were lower in group D compared with Group C.
CONCLUSIONS


Preemptive administration of diphenhydramine provided smooth emergence from anesthesia. It also improved the quality of recovery after maxillofacial surgery.
TRIAL REGISTRATION NUMBER


This study was registered at http://irct.ir (registration number IRCT20130304012695N3).",2022,"Grade of cough during emergence, the severity of pain, analgesic requirements, and hemodynamic changes were lower in group D compared with Group C.
CONCLUSIONS


","['Eighty-five patients undergoing maxillofacial surgery', 'maxillofacial surgeries', 'adult patients']","['diphenhydramine premedication 0.5\xa0mg/kg before anesthesia induction, while the control group (Group C, n\u2009=\u200940) received volume-matched normal saline as a placebo', 'remifentanil 0.2\xa0μg/kg/h and inhalation of isoflurane', 'diphenhydramine/paracetamol', 'diphenhydramine', 'morphine sulfate', 'Paracetamol']","['quality of recovery', 'emergence agitation and postoperative pain', 'Grade of cough during emergence, the severity of pain, analgesic requirements, and hemodynamic changes', 'emergence agitation and quality of recovery', 'incidence of emergence agitation']","[{'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0066814', 'cui_str': 'Morphine sulfate'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",85.0,0.145417,"Grade of cough during emergence, the severity of pain, analgesic requirements, and hemodynamic changes were lower in group D compared with Group C.
CONCLUSIONS


","[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Khajavi', 'Affiliation': 'Department of Anesthesiology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran. khajavim@tums.ac.ir.'}, {'ForeName': 'Armita', 'Initials': 'A', 'LastName': 'Saffarian', 'Affiliation': 'Department of Anesthesiology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fazeleh', 'Initials': 'F', 'LastName': 'Majidi', 'Affiliation': 'Research Development Center, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza Shariat', 'Initials': 'RS', 'LastName': 'Moharari', 'Affiliation': 'Department of Anesthesiology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Pourfakhr', 'Affiliation': 'Department of Anesthesiology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Alireza', 'Initials': 'SA', 'LastName': 'Parhiz', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dental School, Tehran University of Medical Sciences, Tehran, Iran.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-021-06904-4']
796,34044369,"The Effects of an Acute ""Train-Low"" Nutritional Protocol on Markers of Recovery Optimization in Endurance-Trained Male Athletes.","PURPOSE


This study aimed to determine the effects of an acute ""train-low"" nutritional protocol on markers of recovery optimization compared to standard recovery nutrition protocol.
METHODS


After completing a 2-hour high-intensity interval running protocol, 8 male endurance athletes consumed a standard dairy milk recovery beverage (CHO; 1.2 g/kg body mass [BM] of carbohydrate and 0.4 g/kg BM of protein) and a low-carbohydrate (L-CHO; isovolumetric with 0.35 g/kg BM of carbohydrate and 0.5 g/kg BM of protein) dairy milk beverage in a double-blind randomized crossover design. Venous blood and breath samples, nude BM, body water, and gastrointestinal symptom measurements were collected preexercise and during recovery. Muscle biopsy was performed at 0 hour and 2 hours of recovery. Participants returned to the laboratory the following morning to measure energy substrate oxidation and perform a 1-hour distance test.
RESULTS


The exercise protocol resulted in depletion of muscle glycogen stores (250 mmol/kg dry weight) and mild body-water losses (BM loss = 1.8%). Neither recovery beverage replenished muscle glycogen stores (279 mmol/kg dry weight) or prevented a decrease in bacterially stimulated neutrophil function (-21%). Both recovery beverages increased phosphorylation of mTORSer2448 (main effect of time = P < .001) and returned hydration status to baseline. A greater fold increase in p-GSK-3βSer9/total-GSK-3β occurred on CHO (P = .012). Blood glucose (P = .005) and insulin (P = .012) responses were significantly greater on CHO (618 mmol/L per 2 h and 3507 μIU/mL per 2 h, respectively) compared to L-CHO (559 mmol/L per 2 h and 1147 μIU/mL per 2 h, respectively). Rates of total fat oxidation were greater on CHO, but performance was not affected.
CONCLUSION


A lower-carbohydrate recovery beverage consumed after exercise in a ""train-low"" nutritional protocol does not negatively impact recovery optimization outcomes.",2021,Both recovery beverages increased phosphorylation of mTORSer2448 (main effect of time = P < .001) and returned hydration status to baseline.,['Endurance-Trained Male Athletes'],"['acute ""train-low"" nutritional protocol', 'L-CHO', 'Acute ""Train-Low"" Nutritional Protocol', 'male endurance athletes consumed a standard dairy milk recovery beverage (CHO; 1.2\xa0g/kg body mass [BM]\xa0of carbohydrate and 0.4\xa0g/kg BM of protein) and a low-carbohydrate (L-CHO; isovolumetric with 0.35\xa0g/kg BM of carbohydrate and 0.5\xa0g/kg BM of protein) dairy milk beverage', 'CHO']","['Venous blood and breath samples, nude BM, body water, and gastrointestinal symptom measurements', 'p-GSK-3βSer9/total-GSK-3β', 'Rates of total fat oxidation', 'bacterially stimulated neutrophil function', 'Blood glucose', 'recovery beverage replenished muscle glycogen stores', 'depletion of muscle glycogen stores']","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025932', 'cui_str': 'Mouse, Nude'}, {'cui': 'C0005909', 'cui_str': 'Body water'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}]",8.0,0.13362,Both recovery beverages increased phosphorylation of mTORSer2448 (main effect of time = P < .001) and returned hydration status to baseline.,"[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Russo', 'Affiliation': ''}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Della Gatta', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Garnham', 'Affiliation': ''}, {'ForeName': 'Judi', 'Initials': 'J', 'LastName': 'Porter', 'Affiliation': ''}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Burke', 'Affiliation': ''}, {'ForeName': 'Ricardo J S', 'Initials': 'RJS', 'LastName': 'Costa', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0847']
797,34044367,Morning Preconditioning Exercise Does Not Increase Afternoon Performance in Competitive Runners.,"PURPOSE


Preconditioning exercise is a widely used strategy believed to enhance performance later the same day. The authors examined the influence of preconditioning exercises 6 hours prior to a time-to-exhaustion (TTE) test during treadmill running.
METHODS


Ten male competitive runners (age = 26 [3] y, height = 184 [8] cm, weight = 73 [9] kg, maximum oxygen consumption = 72 [7] mL·kg-1·min-1) did a preconditioning session of running (RUN) or resistance exercise (RES) or no morning exercise (NoEx) in a randomized order, separated by >72 hours. The RUN consisted of 15 minutes of low-intensity running and 4 × 15 seconds at race pace (21-24 km·h-1) on a treadmill; RES involved 5 minutes of low-intensity running and 2 × 3 repetitions of isokinetic 1-leg shallow squats with maximal mobilization. Following a 6-hour break, electrically evoked force (m. vastus medialis), countermovement jump, running economy, and a TTE of approximately 2 minutes were examined.
RESULTS


Relative to NoEx, no difference was seen for RUN or RES in TTE (mean ± 95% CI: -1.3% ± 3.4% and -0.5% ± 6.0%) or running economy (0.2% ± 1.6% and 1.9% ± 2.7%; all Ps > .05). Jump height was not different for the RUN condition (1.0% ± 2.7%]) but tended to be higher in RES than in the NoEx condition (1.5% ± 1.6%, P = .07). The electrically evoked force tended to reveal low-frequency fatigue (reduced 20:50-Hz peak force ratio) only after RES compared to NoEx (-4.5% ± 4.6%, P = .06).
CONCLUSION


The RUN or RES 6 hours prior to approximately 2 minutes of TTE running test did not improve performance in competitive runners.",2021,"The electrically evoked force tended to reveal low-frequency fatigue (reduced 20:50-Hz peak force ratio) only after RES compared to NoEx (-4.5% ± 4.6%, P = .06).
","['3]\xa0y, height = 184 [8]\xa0cm, weight = 73', 'Ten male competitive runners (age = 26', 'Competitive Runners']","['mL·kg-1·min-1', 'preconditioning session of running (RUN) or resistance exercise (RES) or no morning exercise (NoEx', 'treadmill; RES involved 5 minutes of low-intensity running and 2 × 3 repetitions of isokinetic 1-leg shallow squats with maximal mobilization', 'preconditioning exercises', 'Morning Preconditioning Exercise']","['Jump height', 'Afternoon Performance', 'maximum oxygen consumption = 72 [7']","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1709632', 'cui_str': 'Precondition'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",10.0,0.0554848,"The electrically evoked force tended to reveal low-frequency fatigue (reduced 20:50-Hz peak force ratio) only after RES compared to NoEx (-4.5% ± 4.6%, P = .06).
","[{'ForeName': 'Even Brøndbo', 'Initials': 'EB', 'LastName': 'Dahl', 'Affiliation': ''}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Øygard', 'Affiliation': ''}, {'ForeName': 'Gøran', 'Initials': 'G', 'LastName': 'Paulsen', 'Affiliation': ''}, {'ForeName': 'Bjarne', 'Initials': 'B', 'LastName': 'Rud', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Losnegard', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0747']
798,34037993,"Dupilumab suppresses type 2 inflammatory biomarkers across multiple atopic, allergic diseases.","BACKGROUND


Type 2 inflammation is common in numerous atopic/allergic diseases and can be identified by elevated biomarker levels. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and interleukin-13, key and central drivers of type 2 inflammation.
OBJECTIVE


Assessment of dupilumab effect on type 2 inflammatory biomarkers in atopic dermatitis (AD), asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and eosinophilic esophagitis (EoE).
METHODS


Data were extracted from three randomized placebo-controlled trials of dupilumab in AD (NCT02277743, N = 671; NCT02277769, N = 708; NCT02260986, N = 740); and one each in asthma (NCT02414854, N = 1902); CRSwNP (NCT02898454, N = 448); and EoE (NCT02379052, N = 47). Biomarkers assessed were serum thymus and activation-regulated chemokine (TARC), plasma eotaxin-3, serum total immunoglobulin E (IgE), serum periostin and blood eosinophil count.
RESULTS


Dupilumab versus placebo significantly suppressed most type 2 inflammatory biomarker levels across all studies/indications where data were assessed. Reductions in serum TARC, plasma eotaxin-3 and serum periostin occurred rapidly, whereas reductions in serum total IgE were more gradual. Across diseases, at the end of treatment, median percentage change from baseline in TARC levels ranged from -24.8% to -88.6% (placebo +2.6% to -53.6%); -38.2% to -51.5% (placebo +8.3% to -0.16%) in eotaxin-3; -24.8% to -76.7% (placebo +8.3% to -4.4%) in total IgE; and -13.6% to -41.1% (placebo +10.1% to -6.94%) in periostin levels. Blood eosinophil responses to dupilumab varied by disease, with minimal changes in AD in the SOLO studies (median percentage change from baseline to end of treatment: 0% [95% CI: -15.8, 0]); transient increases followed by decreases to below-baseline levels in asthma (-14.6% [-20.0, -7.7]) and CRSwNP (-29.4% [-40.0, -16.3]); and significant decreases in EoE (-50.0% [-50.0, -33.3]).
CONCLUSION AND CLINICAL RELEVANCE


Dupilumab reduced levels of type 2 biomarkers across clinical studies in patients with AD, asthma, CRSwNP and EoE.",2021,"Biomarkers assessed were serum thymus and activation-regulated chemokine (TARC), plasma eotaxin-3, serum total immunoglobulin E (IgE), serum periostin, and blood eosinophil count.
","['atopic dermatitis (AD), asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and eosinophilic esophagitis (EoE']",['placebo'],"['serum TARC, plasma eotaxin-3, and serum periostin', 'Blood eosinophil responses', 'serum thymus and activation-regulated chemokine (TARC), plasma eotaxin-3, serum total immunoglobulin E (IgE), serum periostin, and blood eosinophil count', 'TARC levels', 'serum total IgE']","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0539535', 'cui_str': 'CCL17 protein, human'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0907797', 'cui_str': 'CCL26 protein, human'}, {'cui': 'C0219433', 'cui_str': 'POSTN protein, human'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0428539', 'cui_str': 'Total immunoglobulin measurement'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.269794,"Biomarkers assessed were serum thymus and activation-regulated chemokine (TARC), plasma eotaxin-3, serum total immunoglobulin E (IgE), serum periostin, and blood eosinophil count.
","[{'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Hamilton', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Harel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Brian N', 'Initials': 'BN', 'LastName': 'Swanson', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brian', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Rice', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Amin', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Radin', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Naimish', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Leda', 'Initials': 'L', 'LastName': 'Mannent', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13954']
799,34034808,Randomized controlled trial of sulforaphane and metabolite discovery in children with Autism Spectrum Disorder.,"BACKGROUND


Sulforaphane (SF), an isothiocyanate in broccoli, has potential benefits relevant to autism spectrum disorder (ASD) through its effects on several metabolic and immunologic pathways. Previous clinical trials of oral SF demonstrated positive clinical effects on behavior in young men and changes in urinary metabolomics in children with ASD.
METHODS


We conducted a 15-week randomized parallel double-blind placebo-controlled clinical trial with 15-week open-label treatment and 6-week no-treatment extensions in 57 children, ages 3-12 years, with ASD over 36 weeks. Twenty-eight were assigned SF and 29 received placebo (PL). Clinical effects, safety and tolerability of SF were measured as were biomarkers to elucidate mechanisms of action of SF in ASD.
RESULTS


Data from 22 children taking SF and 23 on PL were analyzed. Treatment effects on the primary outcome measure, the Ohio Autism Clinical Impressions Scale (OACIS), in the general level of autism were not significant between SF and PL groups at 7 and 15 weeks. The effect sizes on the OACIS were non-statistically significant but positive, suggesting a possible trend toward greater improvement in those on treatment with SF (Cohen's d 0.21; 95% CI - 0.46, 0.88 and 0.10; 95% CI - 0.52, 0.72, respectively). Both groups improved in all subscales when on SF during the open-label phase. Caregiver ratings on secondary outcome measures improved significantly on the Aberrant Behavior Checklist (ABC) at 15 weeks (Cohen's d - 0.96; 95% CI - 1.73, - 0.15), but not on the Social Responsiveness Scale-2 (SRS-2). Ratings on the ABC and SRS-2 improved with a non-randomized analysis of the length of exposure to SF, compared to the pre-treatment baseline (p < 0.001). There were significant changes with SF compared to PL in biomarkers of glutathione redox status, mitochondrial respiration, inflammatory markers and heat shock proteins. Clinical laboratory studies confirmed product safety. SF was very well tolerated and side effects of treatment, none serious, included rare insomnia, irritability and intolerance of the taste and smell.
LIMITATIONS


The sample size was limited to 45 children with ASD and we did not impute missing data. We were unable to document significant changes in clinical assessments during clinical visits in those taking SF compared to PL. The clinical results were confounded by placebo effects during the open-label phase.
CONCLUSIONS


SF led to small yet non-statistically significant changes in the total and all subscale scores of the primary outcome measure, while for secondary outcome measures, caregivers' assessments of children taking SF showed statistically significant improvements compared to those taking PL on the ABC but not the SRS-2. Clinical effects of SF were less notable in children compared to our previous trial of a SF-rich preparation in young men with ASD. Several of the effects of SF on biomarkers correlated to clinical improvements. SF was very well tolerated and safe and effective based on our secondary clinical measures.
TRIAL REGISTRATION


This study was prospectively registered at clinicaltrials.gov (NCT02561481) on September 28, 2015. Funding was provided by the U.S. Department of Defense.",2021,"There were significant changes with SF compared to PL in biomarkers of glutathione redox status, mitochondrial respiration, inflammatory markers and heat shock proteins.","['22 children taking SF and 23 on PL', 'children with Autism Spectrum Disorder', '57 children, ages 3-12\xa0years, with ASD over 36\xa0weeks', '45 children with ASD', 'young men with ASD', 'young men', 'children with ASD']","['oral SF', 'sulforaphane', 'SF', 'Sulforaphane (SF', 'placebo (PL', 'placebo', '15-week open-label treatment and 6-week no-treatment extensions']","['Aberrant Behavior Checklist (ABC', 'Clinical effects, safety and tolerability of SF', 'glutathione redox status, mitochondrial respiration, inflammatory markers and heat shock proteins', 'Caregiver ratings', 'tolerated and safe and effective', 'Ohio Autism Clinical Impressions Scale (OACIS), in the general level of autism', 'Social Responsiveness Scale-2 (SRS-2', 'urinary metabolomics', 'rare insomnia, irritability and intolerance of the taste and smell', 'tolerated and side effects', 'ABC and SRS-2']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0163159', 'cui_str': 'sulforafan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0163159', 'cui_str': 'sulforafan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0163159', 'cui_str': 'sulforafan'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018850', 'cui_str': 'Heat-Shock Protein'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",45.0,0.594997,"There were significant changes with SF compared to PL in biomarkers of glutathione redox status, mitochondrial respiration, inflammatory markers and heat shock proteins.","[{'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Zimmerman', 'Affiliation': 'Departments of Pediatrics, Neurology and Psychiatry, University of Massachusetts Medical School, 55 N. Lake Ave., Worcester, MA, 01655, USA. Andrew.Zimmerman@umassmemorial.org.'}, {'ForeName': 'Kanwaljit', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'Departments of Pediatrics, Neurology and Psychiatry, University of Massachusetts Medical School, 55 N. Lake Ave., Worcester, MA, 01655, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Connors', 'Affiliation': 'Departments of Pediatrics, Neurology and Psychiatry, University of Massachusetts Medical School, 55 N. Lake Ave., Worcester, MA, 01655, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Pharmacology and Molecular Sciences, and The Cullman Chemoprotection Center, Johns Hopkins University School of Medicine, 725 N. Wolfe St., Baltimore, MD, 21205, USA.'}, {'ForeName': 'Anita A', 'Initials': 'AA', 'LastName': 'Panjwani', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, and iMIND Hopkins, Johns Hopkins University School of Medicine, 600 N. Wolfe St., Baltimore, MD, 21287, USA.'}, {'ForeName': 'Li-Ching', 'Initials': 'LC', 'LastName': 'Lee', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St., Baltimore, MD, 21205, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Diggins', 'Affiliation': 'Departments of Pediatrics, Neurology and Psychiatry, University of Massachusetts Medical School, 55 N. Lake Ave., Worcester, MA, 01655, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Foley', 'Affiliation': 'Departments of Pediatrics, Neurology and Psychiatry, University of Massachusetts Medical School, 55 N. Lake Ave., Worcester, MA, 01655, USA.'}, {'ForeName': 'Stepan', 'Initials': 'S', 'LastName': 'Melnyk', 'Affiliation': 'Department of Pediatrics, University of Arkansas for Medical Sciences, 4301 W. Markham St., Little Rock, AR, 72205, USA.'}, {'ForeName': 'Indrapal N', 'Initials': 'IN', 'LastName': 'Singh', 'Affiliation': ""Barrow Neurologic Institute at Phoenix Children's Hospital and Department of Child Health, University of Arizona College of Medicine - Phoenix, 475 N. 5th St., Phoenix, AZ, 85004, USA.""}, {'ForeName': 'S Jill', 'Initials': 'SJ', 'LastName': 'James', 'Affiliation': 'Department of Pediatrics, University of Arkansas for Medical Sciences, 4301 W. Markham St., Little Rock, AR, 72205, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Frye', 'Affiliation': ""Barrow Neurologic Institute at Phoenix Children's Hospital and Department of Child Health, University of Arizona College of Medicine - Phoenix, 475 N. 5th St., Phoenix, AZ, 85004, USA.""}, {'ForeName': 'Jed W', 'Initials': 'JW', 'LastName': 'Fahey', 'Affiliation': 'Department of Pharmacology and Molecular Sciences, and The Cullman Chemoprotection Center, Johns Hopkins University School of Medicine, 725 N. Wolfe St., Baltimore, MD, 21205, USA.'}]",Molecular autism,['10.1186/s13229-021-00447-5']
800,34036337,Repeated Passive Mobilization to Stimulate Vascular Function in Individuals of Advanced Age Who Are Chronically Bedridden: A Randomized Controlled Trial.,"BACKGROUND


Vascular dysfunction and associated disorders are major side effects of chronic bed rest, yet passive mobilization as a potential treatment has only been theorized so far. This study investigated the effects of passive mobilization treatment on vascular function in older, chronically bedridden people.
METHOD


The study sample was 45 chronically bedridden people of advanced age (mean age: 87 years; 56% female; mean bed rest: 4 years) randomly assigned to a treatment (n = 23) or a control group (CTRL, n = 22). The treatment group received passive mobilization twice daily (30 minutes, 5 times/wk) for 4 weeks. A kinesiologist performed passive mobilization by passive knee flexion/extension at 1 Hz in one leg (treated leg [T-leg] vs control leg [Ctrl-leg]). The CTRL group received routine treatment. The primary outcome was changes in peak blood flow (∆peak) as measured with the single passive leg movement test at the common femoral artery.
RESULTS


∆Peak was increased in both legs in the Treatment group (+90.9 mL/min, p < .001, in T-leg and +25.7 mL/min, p = .039 in Ctrl-leg). No difference in peak blood flow after routine treatment was found in the CTRL group.
CONCLUSION


Improvement in vascular function after 4 weeks of passive mobilization was recorded in the treatment group. Passive mobilization may be advantageously included in standard clinical practice as an effective strategy to treat vascular dysfunction in persons with severely limited mobility.",2022,"RESULTS


∆Peak was increased in both legs in the Treatment group (+90.9 ml/min, p<0.001, in T-leg and +25.7 ml/min, p=0.039 in ctrl-leg).","['persons with severely limited mobility', 'individuals of advanced age who are chronically bedridden', 'older, chronically bedridden people', '45 chronically bedridden people of advanced age (mean age 87 years; 56% female; mean bed rest 4 years']","['Repeated passive mobilization', 'passive mobilization treatment', 'CTRL', 'passive mobilization', 'control group (CTRL']","['vascular function', 'peak blood flow', 'peak blood flow (∆Peak) as measured with the single passive leg movement test (sPLM']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0700572', 'cui_str': 'Reduced mobility'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0741453', 'cui_str': 'Bedridden'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0859254,"RESULTS


∆Peak was increased in both legs in the Treatment group (+90.9 ml/min, p<0.001, in T-leg and +25.7 ml/min, p=0.039 in ctrl-leg).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedrinolla', 'Affiliation': 'Department of Neurosciences, Biomedicine, and Movement Science, Section of Movement Science, University of Verona, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Magliozzi', 'Affiliation': 'Department of Neurosciences, Biomedicine, and Movement Science, Section of Movement Science, University of Verona, Italy.'}, {'ForeName': 'Alessandro L', 'Initials': 'AL', 'LastName': 'Colosio', 'Affiliation': 'Department of Neurosciences, Biomedicine, and Movement Science, Section of Movement Science, University of Verona, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Danese', 'Affiliation': 'Department of Life and Reproduction Sciences, Laboratory of Clinical Biochemistry, University of Verona, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Gelati', 'Affiliation': 'Department of Life and Reproduction Sciences, Laboratory of Clinical Biochemistry, University of Verona, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Rossi', 'Affiliation': 'Department of Neurosciences, Biomedicine, and Movement Science, Section of Movement Science, University of Verona, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pogliaghi', 'Affiliation': 'Department of Neurosciences, Biomedicine, and Movement Science, Section of Movement Science, University of Verona, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Calabrese', 'Affiliation': 'Department of Neurosciences, Biomedicine, and Movement Science, Section of Movement Science, University of Verona, Italy.'}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'Muti', 'Affiliation': 'Mons. Mazzali Foundation, Mantua, Italy.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Cè', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Esposito', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lippi', 'Affiliation': 'Department of Life and Reproduction Sciences, Laboratory of Clinical Biochemistry, University of Verona, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Schena', 'Affiliation': 'Department of Neurosciences, Biomedicine, and Movement Science, Section of Movement Science, University of Verona, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Venturelli', 'Affiliation': 'Department of Neurosciences, Biomedicine, and Movement Science, Section of Movement Science, University of Verona, Italy.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glab148']
801,34032906,Acupuncture is associated with a positive effect on odour discrimination in patients with postinfectious smell loss-a controlled prospective study.,"INTRODUCTION


Smell disorders are common in the general population and occur e.g., after infections, trauma or idiopathically Treatment strategies for smell loss range from surgery, medication to olfactory training, depending on the pathology, but they are limited This study examined the effect of acupuncture on olfactory function.
METHODS


Sixty patients with smell loss following infections of the upper respiratory tract were included in this investigation Half of the study group were randomly assigned to verum acupuncture and the other half to sham acupuncture Olfaction was measured by means of the ""Sniffin' Sticks"" test battery (odour threshold, discrimination and identification).
RESULTS


Compared to sham acupuncture, verum was associated with an improvement of smell function as measured by the TDI score (p = 0.039) The improvement was largely determined by improvement in odour discrimination, and was significantly better in patients with a shorter duration of the disorder.
CONCLUSION


The present results suggest that acupuncture is an effective supplementary treatment option for patients with olfactory loss.",2022,"Compared to sham acupuncture, verum was associated with an improvement of smell function as measured by the TDI score (p = 0.039)","['patients with olfactory loss', 'Sixty patients with smell loss following infections of the upper respiratory tract were included in this investigation Half of the study group', 'patients with postinfectious smell loss']","['acupuncture', 'Acupuncture', 'verum acupuncture and the other half to sham acupuncture Olfaction was measured by means of the ""Sniffin\' Sticks"" test battery (odour threshold, discrimination and identification']","['TDI score', 'smell function', 'odour discrimination']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0458578', 'cui_str': 'Upper respiratory tract structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}]","[{'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]",60.0,0.0288299,"Compared to sham acupuncture, verum was associated with an improvement of smell function as measured by the TDI score (p = 0.039)","[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Drews', 'Affiliation': 'Department of Otorhinolaryngology, Smell and Taste Clinic, Technische Universität Dresden, Technical University of Dresden Medical School, Fetscherstrasse 74, 01307, Dresden, Germany. Tanja.Drews@uniklinikum-dresden.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Department of Otorhinolaryngology, Smell and Taste Clinic, Technische Universität Dresden, Technical University of Dresden Medical School, Fetscherstrasse 74, 01307, Dresden, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Rochlitzer', 'Affiliation': 'Department of Otorhinolaryngology, Smell and Taste Clinic, Technische Universität Dresden, Technical University of Dresden Medical School, Fetscherstrasse 74, 01307, Dresden, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hauswald', 'Affiliation': 'Department of Otorhinolaryngology, Smell and Taste Clinic, Technische Universität Dresden, Technical University of Dresden Medical School, Fetscherstrasse 74, 01307, Dresden, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Hähner', 'Affiliation': 'Department of Otorhinolaryngology, Smell and Taste Clinic, Technische Universität Dresden, Technical University of Dresden Medical School, Fetscherstrasse 74, 01307, Dresden, Germany.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-021-06872-9']
802,34047839,"Is the 3D exoscope better than the surgical microscope in parotid surgery: a prospective, randomized single-center study.","BACKGROUND


High-definition, three-dimensional (3D) exoscopes are being used to perform a growing number of head and neck surgeries. However, the use of the 3D exoscope in parotid gland surgery has not been previously described. Our initial experience with the VITOM 3D exoscope in the surgical treatment of parotid gland tumors is detailed here.
METHODS


We made a prospective study of patients with benign parotid gland tumors indicated for surgical resection. Between January and December 2018, patients were randomly assigned to undergo surgery assisted with the VITOM 3D system (n = 31) or an operating microscope (n = 40). Visualization quality (greater auricular nerve, digastric muscle, tragal pointer), operating time, conversion rates, and surgical outcomes were compared.
RESULTS


A total of 71 patients underwent superficial (n = 18) or total parotidectomy (n = 53). No exoscope-related complications were observed. Five patients undergoing exoscope-guided deep lobe surgery required intraoperative conversion to a microscope. No differences were observed in the subjective quality of intraoperative visualization of key anatomical structures. However, a significantly higher percentage of patients in the exoscope group developed transient facial nerve paralysis (n = 9; 29% vs. n = 4, 10%).
CONCLUSIONS


These findings suggest that the VITOM 3D is a valid visualization tool for parotid gland surgery, comparable to the operating microscope but with higher resolution 3D visualization, an increased degree of freedom of movement, and better ergonomics. However, the high rate of transient nerve palsy, possibly related to decreased depth perception and the brief learning curve, merits further investigation.",2022,No differences were observed in the subjective quality of intraoperative visualization of key anatomical structures.,"['patients with benign parotid gland tumors', 'Five patients undergoing', '71 patients underwent superficial (n\u2009=\u200918) or total parotidectomy (n\u2009=\u200953']","['surgical resection', 'exoscope-guided deep lobe surgery required intraoperative conversion to a microscope', 'surgery assisted with the VITOM 3D system (n\u2009=\u200931) or an operating microscope']","['Visualization quality (greater auricular nerve, digastric muscle, tragal pointer), operating time, conversion rates, and surgical outcomes', 'subjective quality of intraoperative visualization of key anatomical structures', 'transient facial nerve paralysis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0496857', 'cui_str': 'Benign neoplasm of parotid gland'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0193318', 'cui_str': 'Complete parotidectomy'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0181839', 'cui_str': 'Microscope'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1744553', 'cui_str': 'Structure of great auricular nerve'}, {'cui': 'C0224155', 'cui_str': 'Digastric muscle structure'}, {'cui': 'C0324413', 'cui_str': 'Pointer'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0700276', 'cui_str': 'Anatomical structure'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0015469', 'cui_str': 'Facial palsy'}]",71.0,0.0485968,No differences were observed in the subjective quality of intraoperative visualization of key anatomical structures.,"[{'ForeName': 'Ewelina', 'Initials': 'E', 'LastName': 'Bartkowiak', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Poznań University of Medical Sciences, Poznan, Poland. ewelina.anna.bartkowiak@gmail.com.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Łuczewski', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Poznań University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Jadzia Tin-Tsen', 'Initials': 'JT', 'LastName': 'Chou', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Poznań University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Wierzbicka', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Poznań University of Medical Sciences, Poznan, Poland.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-021-06876-5']
803,34057279,Impact of a micro-net mesh technology covering stent on coronary microvascular dysfunction in patients with high thrombus burden.,"BACKGROUND


Highly thrombotic coronary lesions continue to be a serious and clinically significant problem that is not effectively and completely addressed by current technology.
OBJECTIVES


We aimed to investigate whether a micro-net mesh (MNM) technology covering stent could preserve the index of microcirculatory resistance (IMR) after percutaneous coronary intervention (PCI) in patients with high thrombus burden.
METHODS AND RESULTS


Fifty-two patients with non-ST elevation myocardial infarction or ST Elevation Myocardial Infarction and high thrombus burden (TIMI thrombus grade ≥ 3) were randomized into two groups, PCI with a MNM covering stent (MNM group, n = 25) and PCI with any commercially available stent (DES group, n = 27). As the primary endpoint, IMR was measured immediately after PCI using a pressure-temperature sensor-tipped coronary wire. The secondary endpoint was left ventricular ejection fraction (LVEF) at 6 months of follow-up. The IMR in the MNM group was significantly lower in comparison to the DES group (33.2 [21.3, 48.9] vs. 57.2 [39.9, 98.0], p = 0.005). No significant differences were observed in baseline LVEF (54.5 ± 10.2% vs. 53.1 ± 6.87%, p = .57), while LVEF was significantly improved at follow-up in the MNM group (61.1 ± 7.1% vs. 53.9 ± 6.35%, p = .0001).
CONCLUSION


MNM technology significantly improved coronary microvascular dysfunction after PCI in patient with acute coronary syndrome and appears as a useful technological option for thrombus management.",2022,"The IMR in the MNM group was significantly lower in comparison to the DES group (33.2 [21.3, 48.9] vs. 57.2 [39.9, 98.0], p = 0.005).","['patients with high thrombus burden', 'patient with acute coronary syndrome', 'Fifty-two patients with non-ST elevation myocardial infarction or ST Elevation Myocardial Infarction and high thrombus burden (TIMI thrombus grade\u2009≥\u20093']","['MNM technology', 'micro-net mesh (MNM) technology covering stent', 'PCI with a MNM covering stent (MNM group, n\xa0=\xa025) and PCI with any commercially available stent (DES', 'percutaneous coronary intervention (PCI', 'DES', 'micro-net mesh technology covering stent']","['coronary microvascular dysfunction', 'left ventricular ejection fraction (LVEF', 'baseline LVEF', 'LVEF', 'index of microcirculatory resistance (IMR', 'IMR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C1276061', 'cui_str': 'Acute non-ST segment elevation myocardial infarction'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}]","[{'cui': 'C3696962', 'cui_str': 'Coronary microvascular dysfunction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",52.0,0.0740023,"The IMR in the MNM group was significantly lower in comparison to the DES group (33.2 [21.3, 48.9] vs. 57.2 [39.9, 98.0], p = 0.005).","[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Noirclerc', 'Affiliation': 'Department of Cardiology, Hospital Center, Annecy-Genevois, France.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Marliere', 'Affiliation': 'Department of Cardiology, University Hospital, Grenoble-Alpes, France.'}, {'ForeName': 'Akader', 'Initials': 'A', 'LastName': 'Bakhti', 'Affiliation': 'Department of Cardiology, Hospital Center, Annecy-Genevois, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Mangin', 'Affiliation': 'Department of Cardiology, Hospital Center, Annecy-Genevois, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Cassar', 'Affiliation': 'Department of Cardiology, Hospital Center, Annecy-Genevois, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Vautrin', 'Affiliation': 'Department of Cardiology, University Hospital, Grenoble-Alpes, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Piliero', 'Affiliation': 'Department of Cardiology, University Hospital, Grenoble-Alpes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Ormezzano', 'Affiliation': 'Department of Cardiology, University Hospital, Grenoble-Alpes, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Bouvaist', 'Affiliation': 'Department of Cardiology, University Hospital, Grenoble-Alpes, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Riou', 'Affiliation': 'University Grenoble alpes, INSERM U1039, Bioclinic Radiopharmaceutics Laboratory, Grenoble, France.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Vanzetto', 'Affiliation': 'Department of Cardiology, University Hospital, Grenoble-Alpes, France.'}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Belle', 'Affiliation': 'Department of Cardiology, Hospital Center, Annecy-Genevois, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Barone-Rochette', 'Affiliation': 'Department of Cardiology, University Hospital, Grenoble-Alpes, France.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29782']
804,34050419,Effects of the short-stitch technique for midline abdominal closure: short-term results from the randomised-controlled ESTOIH trial.,"PURPOSE


The short-stitch technique for midline laparotomy closure has been shown to reduce hernia rates, but long stitches remain the standard of care and the effect of the short-stitch technique on short-term results is not well known. The aim of this study was to compare the two techniques, using an ultra-long-term absorbable elastic suture material.
METHODS


Following elective midline laparotomy, 425 patients in 9 centres were randomised to receive wound closure using the short-stitch (USP 2-0 single thread, n = 215) or long-stitch (USP 1 double loop, n = 210) technique with a poly-4-hydroxybutyrate-based suture material (Monomax ® ). Here, we report short-term surgical outcomes.
RESULTS


At 30 (+10) days postoperatively, 3 (1.40%) of 215 patients in the short-stitch group and 10 (4.76%) of 210 patients in the long-stitch group had developed burst abdomen [OR 0.2830 (0.0768-1.0433), p = 0.0513]. Ruptured suture, seroma and hematoma and other wound healing disorders occurred in small numbers without differences between groups. In a planned Cox proportional hazard model for burst abdomen, the short-stitch group had a significantly lower risk [HR 0.1783 (0.0379-0.6617), p = 0.0115].
CONCLUSIONS


Although this trial revealed no significant difference in short-term results between the short-stitch and long-stitch techniques for closure of midline laparotomy, a trend towards a lower rate of burst abdomen in the short-stitch group suggests a possible advantage of the short-stitch technique.
TRIAL REGISTRY


NCT01965249, registered October 18, 2013.",2022,"Although this trial revealed no significant difference in short-term results between the short-stitch and long-stitch techniques for closure of midline laparotomy, a trend towards a lower rate of burst abdomen in the short-stitch group suggests a possible advantage of the short-stitch technique.
","['midline abdominal closure', '425 patients in 9 centres']","['short-stitch technique', 'wound closure using the short-stitch (USP 2-0 single thread, n\u2009=\u2009215) or long-stitch (USP 1 double loop, n\u2009=\u2009210) technique with a poly-4-hydroxybutyrate-based suture material (Monomax ® ', 'elective midline laparotomy', 'ultra-long-term absorbable elastic suture material']","['hernia rates', 'rate of burst abdomen', 'Ruptured suture, seroma and hematoma and other wound healing disorders', 'burst abdomen']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0032400', 'cui_str': 'Poly(rA)'}, {'cui': 'C0000503', 'cui_str': '4-hydroxybutyrate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038969', 'cui_str': 'Surgical suture'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}]","[{'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0607422', 'cui_str': 'Abdoman (drug)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0780548,"Although this trial revealed no significant difference in short-term results between the short-stitch and long-stitch techniques for closure of midline laparotomy, a trend towards a lower rate of burst abdomen in the short-stitch group suggests a possible advantage of the short-stitch technique.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Albertsmeier', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, LMU University Hospital, Ludwig-Maximilians-Universität (LMU) Munich, 81377, Munich, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hofmann', 'Affiliation': 'Allgemein-, Viszeral- und Tumorchirurgie, Wilhelminenspital, Montleartstr. 37, 1160, Vienna, Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Baumann', 'Affiliation': 'Department of Medical Scientific Affairs, Aesculap AG, Am Aesculap Platz, 78532, Tuttlingen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Riedl', 'Affiliation': 'Klinik am Eichert, Allgemeinchirurgie, Alb Fils Klinik GmbH, Eichertstr.3, 73035, Göppingen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Reisensohn', 'Affiliation': 'Klinik am Eichert, Allgemeinchirurgie, Alb Fils Klinik GmbH, Eichertstr.3, 73035, Göppingen, Germany.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Kewer', 'Affiliation': 'Klinik für Allgemein-, Viszeral- und Gefäßchirurgie, Klinikum Landkreis Tuttlingen, Zeppelinstr. 21, 78532, Tuttlingen, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hoelderle', 'Affiliation': 'Klinik für Allgemein-, Viszeral- und Gefäßchirurgie, Klinikum Landkreis Tuttlingen, Zeppelinstr. 21, 78532, Tuttlingen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shamiyeh', 'Affiliation': 'Klinik für Allgemein- und Viszeralchirurgie, Kepler Universitätsklinikum GmbH, Krankenhausstr. 9, 4021, Linz, Austria.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Klugsberger', 'Affiliation': 'Klinik für Allgemein- und Viszeralchirurgie, Kepler Universitätsklinikum GmbH, Krankenhausstr. 9, 4021, Linz, Austria.'}, {'ForeName': 'T D', 'Initials': 'TD', 'LastName': 'Maier', 'Affiliation': 'Allgemein- und Viszeralchirurgie, Robert-Bosch-Krankenhaus, Auerbachstr. 110, 70376, Stuttgart, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schumacher', 'Affiliation': 'Chirurgische Klinik, Städtisches Klinikum Braunschweig, Salzdahlumer Str. 90, 38126, Brunswick, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Köckerling', 'Affiliation': 'Klinik für Chirurgie, Viszeral- und Gefäßchirurgie, Vivantes Klinikum Spandau, Neue Bergstr. 6, 13585, Berlin, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Pession', 'Affiliation': 'Zentrum der Chirurgie, Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Frankfurt, Theodor-Stern-Kai, 60590, Frankfurt am Main, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weniger', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, LMU University Hospital, Ludwig-Maximilians-Universität (LMU) Munich, 81377, Munich, Germany.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Fortelny', 'Affiliation': 'Allgemein-, Viszeral- und Tumorchirurgie, Wilhelminenspital, Montleartstr. 37, 1160, Vienna, Austria. dr.fortelny@gmail.com.'}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-021-02410-y']
805,34057275,Reduction of door-to-balloon time in patients with ST-elevation myocardial infarction by single-catheter primary percutaneous coronary intervention method.,"OBJECTIVES


The objectives of this study is to confirm reduction of door-to-balloon (D2B) time with single-catheter percutaneous coronary intervention (SC-PCI) method.
BACKGROUND


Reduction of total ischemic time is important in the emergency treatment of ST-elevation myocardial infarction (STEMI). There have been no established methods in primary percutaneous coronary intervention (PCI) to shorten ischemic time via radial access. Ikari left curve was reported as a universal guiding catheter for left and right coronary arteries. Several procedure steps can be skipped by SC-PCI method as the advantage of a universal catheter.
METHODS


This study is a retrospective analysis of a total of 1,275 consecutive STEMI cases treated with primary PCI in 14 hospitals. Patients were divided into two groups, SC-PCI method (n = 298) and conventional PCI method (n = 977). Primary endpoints were door-to-balloon (D2B) time and radiation exposure dose.
RESULTS


The mean age was 68 ± 13 years old. Radial access was used in 85% of participants. PCI success was achieved in 99.5% of participants and the SC-PCI method was successfully performed in 92.6%. The D2B time was shorter (68 ± 46 vs. 74 ± 50 min, respectively; p = .02), and the radiation exposure dose was lower (1,664 ± 970 vs. 2008 ± 1,605 mGy, respectively; p < .0001) in the SC-PCI group than in the conventional group.
CONCLUSION


Primary PCI with SC-PCI method for patients with STEMI demonstrated shorter D2B time and lower radiation exposure dose.",2022,"The D2B time was shorter (68 ± 46 vs. 74 ± 50 min, respectively; p = .02), and the radiation exposure dose was lower (1,664 ± 970 vs. 2008 ± 1,605 mGy, respectively; p < .0001) in the SC-PCI group than in the conventional group.
","['patients with ST-elevation myocardial infarction by single-catheter primary percutaneous coronary intervention method', 'The mean age was 68\u2009±\u200913\u2009years old', '1,275 consecutive STEMI cases treated with primary PCI in 14 hospitals']","['conventional PCI method', 'single-catheter percutaneous coronary intervention (SC-PCI']","['Radial access', 'radiation exposure dose', 'reduction of door-to-balloon (D2B) time', 'door-to-balloon (D2B) time and radiation exposure dose', 'D2B time', 'Reduction of door-to-balloon time', 'shorter D2B time', 'PCI success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",1275.0,0.0352847,"The D2B time was shorter (68 ± 46 vs. 74 ± 50 min, respectively; p = .02), and the radiation exposure dose was lower (1,664 ± 970 vs. 2008 ± 1,605 mGy, respectively; p < .0001) in the SC-PCI group than in the conventional group.
","[{'ForeName': 'Kyong Hee', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Cardiology, Tokai University Hospital, Isehara, Kanagawa, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Torii', 'Affiliation': 'Cardiology, Tokai University Hospital, Isehara, Kanagawa, Japan.'}, {'ForeName': 'Mitsutoshi', 'Initials': 'M', 'LastName': 'Oguri', 'Affiliation': 'Cardiology, Kasugai City Hospital, Kasugai, Aichi, Japan.'}, {'ForeName': 'Tsuyosi', 'Initials': 'T', 'LastName': 'Miyaji', 'Affiliation': 'Cardiology, Hosogi Hospital, Kochi, Japan.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Kiyooka', 'Affiliation': 'Cardiology, Tokai University Oiso Hospital, Naka-gun, Kanagawa, Japan.'}, {'ForeName': 'Yuujirou', 'Initials': 'Y', 'LastName': 'Ono', 'Affiliation': 'Cardiology, Higashihiroshima Medical Center, Horoshima, Japan.'}, {'ForeName': 'Kouhei', 'Initials': 'K', 'LastName': 'Asada', 'Affiliation': 'Cardiology, Okamura Memorial Hospital, Shizuoka, Japan.'}, {'ForeName': 'Taichi', 'Initials': 'T', 'LastName': 'Adachi', 'Affiliation': 'Cardiology, Tochigi National Hospital, Tochigi, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Takahashi', 'Affiliation': 'Cardiology, Takahashi Hospital, Kobe, Hyogo, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ikari', 'Affiliation': 'Cardiology, Tokai University Hospital, Isehara, Kanagawa, Japan.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29797']
806,34052121,Effects of mindful breath awareness and muscle relaxation and transcranial electrical stimulation techniques on improving blood pressure status in patients with type 2 diabetes.,"OBJECTIVE


The present study aimed to determine the effects of mindful breath awareness & muscle relaxation (MBMR) and transcranial electrical stimulation (tCES) techniques on improving the systolic and diastolic blood pressure status in patients with type 2 diabetes.
METHODS


The research method was randomized controlled trial (RCT) using split-plot ANOVA (SPANOVA). Thirty patients were selected through purposive sampling from Bonab County Diabetes Association (Iran) and were randomly divided into three 10-member groups, namely MBMR, tCES, and MBMR+tCES groups. Participants received their group interventions in 10 individual sessions. All patients were evaluated for systolic and diastolic blood pressure at two stages, before and immediately after each session. SPANOVA and Bonferroni pairwise comparison tests were used for data analysis.
RESULTS


The results indicated that the MBMR and tCES techniques, alone and in combination, had significant and equal effects on reducing diastolic blood pressure, but the MBMR treatment was more effective in the systolic blood pressure than the tCES.
CONCLUSIONS


The MBMR and tCES techniques were effective and safe in treating hypertension in patients with type 2 diabetes.",2022,"The results indicated that the MBMR and tCES techniques, alone and in combination, had significant and equal effects on reducing diastolic blood pressure, but the MBMR treatment was more effective in the systolic blood pressure than the tCES.
","['patients with type 2 diabetes', 'Thirty patients were selected through purposive sampling from Bonab County Diabetes Association (Iran']","['mindful breath awareness and muscle relaxation and transcranial electrical stimulation techniques', 'namely MBMR, tCES, and MBMR+tCES', 'mindful breath awareness & muscle relaxation (MBMR) and transcranial electrical stimulation (tCES) techniques']","['systolic blood pressure', 'diastolic blood pressure', 'blood pressure status', 'systolic and diastolic blood pressure', 'systolic and diastolic blood pressure status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0026836', 'cui_str': 'Muscle relaxation'}, {'cui': 'C0455803', 'cui_str': 'Transcranial electrical stimulation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",30.0,0.0277426,"The results indicated that the MBMR and tCES techniques, alone and in combination, had significant and equal effects on reducing diastolic blood pressure, but the MBMR treatment was more effective in the systolic blood pressure than the tCES.
","[{'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran. Electronic address: mohammdi.rogayeh@gmail.com.'}, {'ForeName': 'Gholam Hossein', 'Initials': 'GH', 'LastName': 'Javanmard', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alipour', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Zare', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2021.05.002']
807,34051122,Tapentadol results in less deterioration of gastrointestinal function and symptoms than standard opioid therapy in healthy male volunteers.,"BACKGROUND


Tapentadol is a combined opioid agonist and norepinephrine reuptake inhibitor with fewer gastrointestinal side effects at equianalgesic doses compared with classical strong opioids. Previous studies on tapentadol have included multi-morbid patients in whom confounders exclude detailed assessment of the mechanistic effects and strict comparison with other opioids or placebo. This study aimed at investigating the effects of tapentadol and oxycodone on gastrointestinal motility and gastrointestinal side effects.
METHODS


21 healthy males participated in a randomized, double-blind, placebo-controlled, crossover study. Tapentadol (50 mg twice daily), oxycodone (10 mg twice daily), or placebo tablets were administered for 14 days. Segmental gastrointestinal transit times and colonic motility parameters were measured with electromagnetic capsules. Gastrointestinal side effects were assessed using questionnaires.
KEY RESULTS


During dosing with tapentadol, gastrointestinal side effects and motility parameters were on placebo level. Compared with tapentadol, oxycodone increased whole gut transit time by 17.9 hours (p = .015) and rectosigmoid transit time by 6.5 hours (p = .005). Compared with tapentadol, oxycodone also reduced long, fast antegrade colonic movements (p = .001). In comparison with placebo, oxycodone prolonged whole gut transit time by 31.6 hours, (p < .001). Moreover, less long, fast antegrade colonic movements (p = .002) were observed during oxycodone. For oxycodone only, slow colonic movements were associated with gastrointestinal side effects.
CONCLUSIONS & INFERENCES


In this mechanistic study, tapentadol caused significantly less colonic dysmotility and gastrointestinal side effects as compared with oxycodone in equianalgesic doses.",2021,"Moreover, less long, fast antegrade colonic movements (p = .002) were observed during oxycodone.","['healthy male volunteers', '21 healthy males']","['tapentadol', 'standard opioid therapy', 'placebo', 'Tapentadol', 'oxycodone', 'tapentadol, oxycodone', 'placebo, oxycodone', 'placebo tablets', 'tapentadol and oxycodone']","['colonic dysmotility and gastrointestinal side effects', 'Gastrointestinal side effects', 'whole gut transit time', 'gut transit time', 'rectosigmoid transit time', 'fast antegrade colonic movements', 'gastrointestinal function and symptoms', 'long, fast antegrade colonic movements', 'gastrointestinal motility and gastrointestinal side effects', 'Segmental gastrointestinal transit times and colonic motility parameters']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C2001271', 'cui_str': 'tapentadol'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521377', 'cui_str': 'Rectosigmoid structure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0232484', 'cui_str': 'Gastrointestinal transit time'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",21.0,0.024667,"Moreover, less long, fast antegrade colonic movements (p = .002) were observed during oxycodone.","[{'ForeName': 'Esben Bolvig', 'Initials': 'EB', 'LastName': 'Mark', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Rasmus Bach', 'Initials': 'RB', 'LastName': 'Nedergaard', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Tine Maria', 'Initials': 'TM', 'LastName': 'Hansen', 'Affiliation': 'Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Thomas Dahl', 'Initials': 'TD', 'LastName': 'Nissen', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jens Brøndum', 'Initials': 'JB', 'LastName': 'Frøkjaer', 'Affiliation': 'Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'S Mark', 'Initials': 'SM', 'LastName': 'Scott', 'Affiliation': 'Neurogastroenterology Group (GI Physiology Unit), Centre for Neuroscience, Surgery & Trauma, Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Krogh', 'Affiliation': 'Neurogastroenterology Unit, Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Asbjørn Mohr', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.14131']
808,34051120,Randomized controlled trial of home biofeedback therapy versus office biofeedback therapy for fecal incontinence.,"BACKGROUND


Biofeedback therapy is useful for treatment of fecal incontinence (FI), but is not widely available and labor intensive. We investigated if home biofeedback therapy (HBT) is non-inferior to office biofeedback therapy (OBT).
METHODS


Patients with FI (≥1 episode/week) were randomized to HBT or OBT for 6 weeks. HBT was performed daily using novel device that provided resistance training and electrical stimulation with voice-guided instructions. OBT consisted of six weekly sessions. Both methods involved anal strength, endurance, and coordination training. Primary outcome was change in weekly FI episodes. FI improvement was assessed with stool diaries, validated instruments (FISI, FISS, and ICIQ-B), and anorectal manometry using intention-to-treat analysis.
KEY RESULTS


Thirty (F/M = 26/4) FI patients (20 in HBT, 10 in OBT) participated. Weekly FI episodes decreased significantly after HBT (Δ ± 95% confidence interval: 4.7 ± 1.8, compared with baseline, p = 0.003) and OBT (3.7 ± 1.6, p = 0.0003) and HBT was non-inferior to OBT (p = 0.2). The FISI and FISS scores improved significantly in HBT group (p < 0.02). Bowel pattern, bowel control, and quality of life (QOL) domains (ICIQ-B) improved significantly in HBT arm (p < 0.023). Resting and maximum squeeze sphincter pressures significantly improved in both HBT and OBT groups and sustained squeeze pressure in HBT, without group differences.
CONCLUSIONS & INFERENCES


Home biofeedback therapy is non-inferior to OBT for FI treatment. Home biofeedback is safe, effective, improves QOL, and through increased access could facilitate improved management of FI.",2021,"Resting and maximum squeeze sphincter pressures significantly improved in both HBT and OBT groups and sustained squeeze pressure in HBT, without group differences.
","['Patients with FI (≥1 episode/week', 'Thirty (F/M\xa0=\xa026/4', 'fecal incontinence']","['HBT', 'home biofeedback therapy versus office biofeedback therapy', 'Biofeedback therapy', 'HBT and OBT', 'home biofeedback therapy (HBT', 'HBT or OBT']","['change in weekly FI episodes', 'HBT', 'stool diaries, validated instruments (FISI, FISS, and ICIQ-B), and anorectal manometry using intention-to-treat analysis', 'Resting and maximum squeeze sphincter pressures', 'Weekly FI episodes', 'anal strength, endurance, and coordination training', 'OBT', 'Bowel pattern, bowel control, and quality of life (QOL) domains (ICIQ-B', 'safe, effective, improves QOL', 'FISI and FISS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0442603', 'cui_str': 'Office'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0374190', 'cui_str': 'Anorectal manometry'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0419112', 'cui_str': 'Coordination training'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1290944', 'cui_str': 'Anorectal continence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0838235,"Resting and maximum squeeze sphincter pressures significantly improved in both HBT and OBT groups and sustained squeeze pressure in HBT, without group differences.
","[{'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Xiang', 'Affiliation': 'Division of Gastroenterology & Hepatology, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Amol', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Division of Gastroenterology & Hepatology, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Tanisa', 'Initials': 'T', 'LastName': 'Patcharatrakul', 'Affiliation': 'Division of Gastroenterology & Hepatology, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Division of Gastroenterology & Hepatology, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Tennekoon', 'Initials': 'T', 'LastName': 'Karunaratne', 'Affiliation': 'Division of Gastroenterology & Hepatology, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Parr', 'Affiliation': 'Division of Gastroenterology & Hepatology, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Deepak Nag', 'Initials': 'DN', 'LastName': 'Ayyala', 'Affiliation': 'Department of Population Health Sciences, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Department of Population Health Sciences, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Satish S C', 'Initials': 'SSC', 'LastName': 'Rao', 'Affiliation': 'Division of Gastroenterology & Hepatology, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.14168']
809,34053371,Effects of High-Speed Versus Traditional Resistance Training in Older Adults.,"BACKGROUND


The losses of strength, agility, balance, and functionality caused by aging are harmful to the elderly population. Resistance training (RT) may be an efficient tool to mitigate such neuromuscular decline and different RT methods can be used. Therefore, it is important to investigate the different responses to different training methods.
HYPOTHESIS


Eight weeks of traditional resistance training (TRT) are expected to promote similar results to high-speed training (HST) in physical functional performance (PFP) and quality of life in the elderly.
STUDY DESIGN


A clinical trial.
LEVEL OF EVIDENCE


Level 3.
METHODS


Participants (n = 24) with a mean age of 67.8 ± 6.3 years completed 8 weeks of RT. They were allocated into HST (n = 12) and TRT (n = 12). TRT involved training with 10 to 12 repetitions at controlled velocity until momentary muscle failure, while HST involved performing 6 to 8 repetitions at 40% to 60% of 1 repetition maximum (1RM) at maximum velocity. Pre- and posttraining, the participants were tested for (1) maximum strength in the 45° leg press and chest press; (2) PFP in the 30-second chair stand, timed-up-and-go (TUG), and medicine ball throw test; and (3) quality of life.
RESULTS


Both groups improved muscle strength in the 45° leg press, with greater increases for TRT (HST: +21% vs TRT: +49%,  P  = 0.019). There was no change in chest press strength for HST (-0.6%) ( P  = 0.61), but there was a significant increase for the TRT group (+21%,  P  = 0.001). There was a similar improvement ( P  < 0.05) for both groups in TUG (HST: 7%; TRT: 10%), chair stand (HST: 18%; TRT: 21%), and medicine ball throwing performance (HST: 9%; TRT: 9%), with no difference between groups ( P  = 0.08-0.94). Emotional aspect significantly increased by 20% ( P  = 0.04) in HST and 50% ( P  = 0.04) in TRT.
CONCLUSION


Both TRT and HST are able to promote improvements in functional performance in the elderly with greater in strength gains for TRT. Therefore, exercise professionals could choose based on individual characteristics and preferences.
CLINICAL RELEVANCE


The findings provide important insights into how health care professionals can prescribe HST and TRT, considering efficiency, safety, and individual aspects.",2022,"There was a similar improvement ( P  < 0.05) for both groups in TUG (HST: 7%; TRT: 10%), chair stand (HST: 18%; TRT: 21%), and medicine ball throwing performance (HST: 9%; TRT: 9%), with no difference between groups ( P  = 0.08-0.94).","['Participants (n = 24) with a mean age of 67.8 ± 6.3 years completed 8 weeks of RT', 'Older Adults']","['HST', 'Pre- and posttraining', 'High-Speed Versus Traditional Resistance Training', 'TRT', 'traditional resistance training (TRT', 'TRT and HST', 'speed training (HST', 'Resistance training (RT']","['chest press strength for HST', 'physical functional performance (PFP) and quality of life', 'functional performance', 'muscle strength', 'Emotional aspect']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4704690', 'cui_str': 'Physical Functional Performance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0243152', 'cui_str': 'emotional aspects'}]",24.0,0.0283445,"There was a similar improvement ( P  < 0.05) for both groups in TUG (HST: 7%; TRT: 10%), chair stand (HST: 18%; TRT: 21%), and medicine ball throwing performance (HST: 9%; TRT: 9%), with no difference between groups ( P  = 0.08-0.94).","[{'ForeName': 'Itamar P', 'Initials': 'IP', 'LastName': 'Vieira', 'Affiliation': 'Faculdade de Nutrição, Universidade Federal de Goiás, Goiânia, GO, Brazil.'}, {'ForeName': 'Patrícia C B', 'Initials': 'PCB', 'LastName': 'Lobo', 'Affiliation': 'Faculdade de Nutrição, Universidade Federal de Goiás, Goiânia, GO, Brazil.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fisher', 'Affiliation': 'School for Sport, Health and Social Sciences, Southampton Solent University, Southampton, UK.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campilo', 'Affiliation': 'Department of Physical and Sports Sciences, Universidad de Los Lagos, Osorno, Chile.'}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Pimentel', 'Affiliation': 'Faculdade de Nutrição, Universidade Federal de Goiás, Goiânia, GO, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Gentil', 'Affiliation': 'Faculdade de Educação Física e Dança, Universidade Federal de Goiás, Goiânia, GO, Brazil.'}]",Sports health,['10.1177/19417381211015211']
810,34051293,Mirtazapine in Cancer-Associated Anorexia and Cachexia: A Double-Blind Placebo-Controlled Randomized Trial.,"CONTEXT


Few pharmacological interventions are available for cancer-associated anorexia and cachexia. Mirtazapine has been suggested for use in cancer-associated anorexia and cachexia.
OBJECTIVES


This study was conducted to assess the efficacy and tolerability of mirtazapine in cancer-associated anorexia and cachexia.
METHODS


A double-blind placebo-controlled randomized trial. The study included 120 incurable solid tumour patients with anorexia (appetite loss ≥4 on 0 - 10 scale, 10 = maximum appetite loss), cachexia (>5% body weight loss over 6 months or >2% plus body mass index <20) and depression score ≤3 on 0-6 scale (6 = extreme feelings of depression). Patients were 1:1 randomized to receive mirtazapine 15mg daily at night for 8 weeks or placebo. The primary endpoint was change in appetite from baseline to day 28. Other outcomes included changes in quality-of-life, fatigue, depressive symptoms, body weight, lean body mass, handgrip strength, inflammatory markers, adverse events and survival.
RESULTS


48 (80%) patients in the mirtazapine arm and 52 (87%) in the placebo were assessable for the 1ry endpoint. Appetite score increased significantly with mirtazapine as well as with placebo (P < 0.0001 each). The increase in appetite score did not differ significantly between the two arms in the per-protocol and intention-to-treat analysis (P = 0.472 and 0.462, respectively). Mirtazapine was associated with significantly less increase in depressive symptoms and higher prevalence of somnolence. The change in other outcomes did not differ significantly between mirtazapine and placebo.
CONCLUSION


Mirtazapine 15mg at night for 28 days is no better than placebo in improving the appetite of incurable solid tumor patients with cancer-associated anorexia and cachexia.",2021,Appetite score increased significantly with mirtazapine as well as with placebo (p<0.0001 each).,"['120 incurable solid tumour patients with anorexia (appetite loss ≥4 on 0-10 scale, 10= maximum appetite loss), cachexia (>5% body weight loss over 6 months or >2% plus body mass index <20) and depression score ≤3 on 0-6 scale (6= extreme feelings of depression', 'cancer-associated anorexia and cachexia']","['placebo', 'mirtazapine', 'Mirtazapine', 'mirtazapine 15mg daily at night for 8 weeks or placebo']","['change in appetite', 'quality-of-life, fatigue, depressive symptoms, body weight, lean body mass, handgrip strength, inflammatory markers, adverse events and survival', 'appetite score', 'depressive symptoms', 'efficacy and tolerability', 'Appetite score', 'somnolence']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C1145809', 'cui_str': 'Mirtazapine 15 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0426587', 'cui_str': 'Altered appetite'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",120.0,0.646803,Appetite score increased significantly with mirtazapine as well as with placebo (p<0.0001 each).,"[{'ForeName': 'Catherine N', 'Initials': 'CN', 'LastName': 'Hunter', 'Affiliation': 'Palliative Medicine Unit, Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine, Kasr Al-Ainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hesham H', 'Initials': 'HH', 'LastName': 'Abdel-Aal', 'Affiliation': 'Palliative Medicine Unit, Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine, Kasr Al-Ainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Wessam A', 'Initials': 'WA', 'LastName': 'Elsherief', 'Affiliation': 'Palliative Medicine Unit, Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine, Kasr Al-Ainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Dina E', 'Initials': 'DE', 'LastName': 'Farag', 'Affiliation': 'Palliative Medicine Unit, Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine, Kasr Al-Ainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nermine M', 'Initials': 'NM', 'LastName': 'Riad', 'Affiliation': 'Clinical and Chemical Pathology Department, Kasr Al-Ainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Samy A', 'Initials': 'SA', 'LastName': 'Alsirafy', 'Affiliation': 'Palliative Medicine Unit, Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine, Kasr Al-Ainy School of Medicine, Cairo University, Cairo, Egypt. Electronic address: alsirafy@kasralainy.edu.eg.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2021.05.017']
811,34077499,Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial.,"Importance


Continuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy, but its use in type 2 diabetes treated with basal insulin without prandial insulin has not been well studied.
Objective


To determine the effectiveness of CGM in adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices.
Design, Setting, and Participants


This randomized clinical trial was conducted at 15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications.
Interventions


Random assignment 2:1 to CGM (n = 116) or traditional blood glucose meter (BGM) monitoring (n = 59).
Main Outcomes and Measures


The primary outcome was hemoglobin A1c (HbA1c) level at 8 months. Key secondary outcomes were CGM-measured time in target glucose range of 70 to 180 mg/dL, time with glucose level at greater than 250 mg/dL, and mean glucose level at 8 months.
Results


Among 175 randomized participants (mean [SD] age, 57 [9] years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4% [95% CI, -0.8% to -0.1%]; P = .02). In the CGM group, compared with the BGM group, the mean percentage of CGM-measured time in the target glucose range of 70 to 180 mg/dL was 59% vs 43% (adjusted difference, 15% [95% CI, 8% to 23%]; P < .001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, -16% [95% CI, -21% to -11%]; P < .001), and the means of the mean glucose values were 179 mg/dL vs 206 mg/dL (adjusted difference, -26 mg/dL [95% CI, -41 to -12]; P < .001). Severe hypoglycemic events occurred in 1 participant (1%) in the CGM group and in 1 (2%) in the BGM group.
Conclusions and Relevance


Among adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin, continuous glucose monitoring, as compared with blood glucose meter monitoring, resulted in significantly lower HbA1c levels at 8 months.
Trial Registration


ClinicalTrials.gov Identifier: NCT03566693.",2021,"Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4% [95% CI, -0.8% to -0.1%]; P = .02).","['57 [9] years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial', 'adults with poorly controlled type 2 diabetes treated with', '15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with', 'adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices', '175 randomized participants (mean [SD] age', 'Patients With Type 2 Diabetes Treated With Basal Insulin', 'adults with type 2 diabetes']","['basal insulin without prandial insulin, continuous glucose monitoring', 'BGM', 'dL', 'CGM', 'Continuous glucose monitoring (CGM', 'CGM (n\u2009=\u2009116) or traditional blood glucose meter (BGM) monitoring (n\u2009=\u200959', 'Continuous Glucose Monitoring', '1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications']","['HbA1c levels', 'mean percentage of CGM-measured time', 'mean percentage of time', 'mean glucose level', 'mean glucose values', 'Mean HbA1c level', 'CGM-measured time in target glucose range of 70 to 180 mg/dL, time with glucose level', 'Severe hypoglycemic events', 'hemoglobin A1c (HbA1c) level']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0472226', 'cui_str': 'Blood glucose meters'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",175.0,0.25414,"Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4% [95% CI, -0.8% to -0.1%]; P = .02).","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Martens', 'Affiliation': 'International Diabetes Center, Park Nicollet Internal Medicine, Minneapolis, Minnesota.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Bailey', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Ruedy', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Peters', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, California.'}, {'ForeName': 'Shichun', 'Initials': 'S', 'LastName': 'Bao', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Umpierrez', 'Affiliation': 'Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Davida', 'Initials': 'D', 'LastName': 'Kruger', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Bhargava', 'Affiliation': 'Iowa Diabetes Research, West Des Moines.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Young', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill.'}, {'ForeName': 'Janet B', 'Initials': 'JB', 'LastName': 'McGill', 'Affiliation': 'Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Aleppo', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Quang T', 'Initials': 'QT', 'LastName': 'Nguyen', 'Affiliation': 'Las Vegas Endocrinology, Henderson, Nevada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Orozco', 'Affiliation': 'Carteret Medical Group, Morehead City, North Carolina.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Biggs', 'Affiliation': 'Amarillo Medical Specialists, Amarillo, Texas.'}, {'ForeName': 'K Jean', 'Initials': 'KJ', 'LastName': 'Lucas', 'Affiliation': 'Diabetes & Endocrinology Consultants PC, Morehead City, North Carolina.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Polonsky', 'Affiliation': 'Behavioral Diabetes Institute, San Diego, California.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Dexcom Inc, San Diego, California.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'International Diabetes Center, HealthPartners Institute, Minneapolis, Minnesota.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2021.7444']
812,34390604,The Impact of Enriched Resistant Starch Type-2 Cookies on the Gut Microbiome in Hemodialysis Patients: A Randomized Controlled Trial.,"INTRODUCTION


Resistant starch type-2 (RS2) can mitigate inflammation and oxidative stress in hemodialysis (HD) patients. However, there is still a lack of knowledge on the impact of the RS2 on the gut microbiota community in these patients. Thus, this study aims to evaluate the effects of enriched RS2 cookies on the gut microbiome in HD patients.
METHODS AND RESULTS


This comprises a randomized, double-blind, placebo-controlled trial of age-, sex-, and BMI-matched patients and controls. The RS2 group receives enriched RS2 cookies (16 g d -1  of Hi-Maize 260, Ingredion) for 4 weeks, while the placebo group received cookies made with manioc flour. Fecal microbiota composition is evaluated by the 16S ribosomal RNA gene. Analysis of the microbiota reveals that Pielou's evenness is significantly decreased after RS2 supplementation. Notably, it is observed that RS2 intervention upregulates significantly 8 Amplicon Sequencing Variants (ASV's), including Roseburia and Ruminococcus gauvreauii, which are short-chain fatty acids (SCFA) producers. Furthermore, it is associated with the downregulation of 11 ASVs, such as the pro-inflammatory Dialister.
CONCLUSIONS


RS2 intervention for 4 weeks in HD patients effectively alters SCFA producers in the gut microbiota, suggesting that it could be a good nutritional strategy for patients with chronic kidney disease (CKD) on HD.",2021,"SCOPE


Resistant starch type-2 (RS2), can mitigate inflammation and oxidative stress in hemodialysis (HD) patients.","['hemodialysis (HD) patients', 'HD patients', 'controlled trial of age-, sex-, and BMI-matched patients and controls', 'Hemodialysis Patients', 'patients with CKD on HD']","['Enriched Resistant Starch Type-2 Cookies', 'RS2 intervention', 'SCOPE\n\n\nResistant starch type-2 (RS2', 'placebo', 'cookies made with manioc flour', 'RS2 cookies']","[""Pielou's evenness"", 'Fecal microbiota composition']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C3853210', 'cui_str': 'Cookie'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007335', 'cui_str': 'Manihot esculenta'}, {'cui': 'C0016260', 'cui_str': 'Flour'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",,0.160275,"SCOPE


Resistant starch type-2 (RS2), can mitigate inflammation and oxidative stress in hemodialysis (HD) patients.","[{'ForeName': 'Julie Ann', 'Initials': 'JA', 'LastName': 'Kemp', 'Affiliation': 'Graduate Program in Cardiovascular Sciences, Fluminense Federal University (UFF), Niterói, RJ, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Regis de Paiva', 'Affiliation': 'Graduate Program in Cardiovascular Sciences, Fluminense Federal University (UFF), Niterói, RJ, Brazil.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'Fragoso Dos Santos', 'Affiliation': 'Department of Marine Biology, Fluminense Federal University (UFF), Niterói, RJ, Brazil.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Emiliano de Jesus', 'Affiliation': 'Department of Marine Biology, Fluminense Federal University (UFF), Niterói, RJ, Brazil.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Craven', 'Affiliation': 'Wolfson Wohl Translational Research Centre, Institute of Cancer Sciences, University of Glasgow, Bearsden, Glasgow, UK.'}, {'ForeName': 'Umer', 'Initials': 'U', 'LastName': 'Z Ijaz', 'Affiliation': 'School of Engineering University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Alvarenga Borges', 'Affiliation': 'Graduate Program in Cardiovascular Sciences, Fluminense Federal University (UFF), Niterói, RJ, Brazil.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'G Shiels', 'Affiliation': 'Wolfson Wohl Translational Research Centre, Institute of Cancer Sciences, University of Glasgow, Bearsden, Glasgow, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Mafra', 'Affiliation': 'Graduate Program in Cardiovascular Sciences, Fluminense Federal University (UFF), Niterói, RJ, Brazil.'}]",Molecular nutrition & food research,['10.1002/mnfr.202100374']
813,34036237,Impact of Conditioning Intensity and Genomics on Relapse After Allogeneic Transplantation for Patients With Myelodysplastic Syndrome.,"PURPOSE


Patients with myelodysplastic syndrome (MDS) are at risk of relapse after allogeneic hematopoietic cell transplantation. The utility of ultra-deep genomic testing to predict and the impact of conditioning intensity to prevent MDS relapse are unknown.
METHODS


Targeted error-corrected DNA sequencing was performed on preconditioning blood samples from patients with MDS (n = 48) from the Blood and Marrow Transplant Clinical Trials Network 0901 phase III randomized clinical trial, which compared outcomes by allogeneic hematopoietic cell transplantation conditioning intensity in adult patients with < 5% marrow myeloblasts and no leukemic myeloblasts in blood on morphological analysis at the time of pretransplant assessment. Clinical end points (53-month median follow-up) included transplant-related mortality (TRM), relapse, relapse-free survival (RFS), and overall survival (OS). Of the 48 patients examined, 14 experienced TRM, 23 are relapse-free, and 11 relapsed, of which 7 died.
RESULTS


Using a previously described set of 10 gene regions, 42% of patients (n = 20) had mutations detectable before random assignment to reduced intensity conditioning (RIC) or myeloablative conditioning (MAC). Testing positive was associated with increased rates of relapse (3-year relapse, 40%  v  11%;  P  = .022) and decreased OS (3-year OS, 55%  v  79%,  P  = .045). In those testing positive, relapse rates were higher (3-year relapse, 75%  v  17%;  P  = .003) and RFS was lower (3-year RFS, 13%  v  49%;  P  = .003) in RIC versus MAC arms. Testing additional genes, including those associated with MDS, did not improve prognostication.
CONCLUSION


This study provides evidence that targeted DNA sequencing in patients with MDS before transplant can identify those with highest post-transplant relapse rates. In those testing positive, random assignment to MAC lowered but did not eliminate relapse risk.",2021,"In those testing positive, relapse rates were higher (3-year relapse, 75%  v  17%;  P  = .003) and RFS was lower (3-year RFS, 13%  v  49%;  P  = .003) in RIC versus MAC arms.","['patients with MDS (n = 48) from the Blood and Marrow Transplant Clinical Trials Network 0901 phase III randomized clinical trial', 'Patients with myelodysplastic syndrome (MDS', '48 patients examined, 14 experienced TRM, 23 are relapse-free, and 11 relapsed, of which 7 died', 'Patients With Myelodysplastic Syndrome', 'adult patients with < 5% marrow myeloblasts and no leukemic myeloblasts in blood on morphological analysis at the time of pretransplant assessment']","['Allogeneic Transplantation', 'allogeneic hematopoietic cell transplantation', 'allogeneic hematopoietic cell transplantation conditioning intensity']","['RFS', 'Relapse', 'relapse rates', 'OS', 'relapse risk', 'rates of relapse (3-year relapse', 'transplant-related mortality (TRM), relapse, relapse-free survival (RFS), and overall survival (OS', 'intensity conditioning (RIC) or myeloablative conditioning (MAC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0420616', 'cui_str': 'Patient examined'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0229633', 'cui_str': 'Myeloblast'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.335677,"In those testing positive, relapse rates were higher (3-year relapse, 75%  v  17%;  P  = .003) and RFS was lower (3-year RFS, 13%  v  49%;  P  = .003) in RIC versus MAC arms.","[{'ForeName': 'Laura W', 'Initials': 'LW', 'LastName': 'Dillon', 'Affiliation': 'Laboratory of Myeloid Malignancies, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Gege', 'Initials': 'G', 'LastName': 'Gui', 'Affiliation': 'Laboratory of Myeloid Malignancies, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Brent R', 'Initials': 'BR', 'LastName': 'Logan', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'Fei', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Ghannam', 'Affiliation': 'Laboratory of Myeloid Malignancies, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Yuesheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Laboratory of Myeloid Malignancies, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Licon', 'Affiliation': 'ArcherDX, Boulder, CO.'}, {'ForeName': 'Edwin P', 'Initials': 'EP', 'LastName': 'Alyea', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Bashey', 'Affiliation': 'Blood and Marrow Transplant Program at Northside Hospital, Atlanta, GA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Devine', 'Affiliation': 'National Marrow Donor Program and Center for International Blood and Marrow Transplant Research, Minneapolis, MN.'}, {'ForeName': 'Hugo F', 'Initials': 'HF', 'LastName': 'Fernandez', 'Affiliation': 'Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Giralt', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hamadani', 'Affiliation': 'West Virginia University Medicine, Morgantown, WV.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Howard', 'Affiliation': 'National Marrow Donor Program and Center for International Blood and Marrow Transplant Research, Minneapolis, MN.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Maziarz', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Porter', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Warlick', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Marcelo C', 'Initials': 'MC', 'LastName': 'Pasquini', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Scott', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Mitchell E', 'Initials': 'ME', 'LastName': 'Horwitz', 'Affiliation': 'Duke University, Durham, NC.'}, {'ForeName': 'H Joachim', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Hourigan', 'Affiliation': 'Laboratory of Myeloid Malignancies, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}]",JCO precision oncology,['10.1200/PO.20.00355']
814,34036235,Protein Signature Predicts Response to Neoadjuvant Treatment With Chemotherapy and Bevacizumab in HER2-Negative Breast Cancers.,"PURPOSE


Antiangiogenic therapy using bevacizumab has proven effective for a number of cancers; however, in breast cancer (BC), there is an unmet need to identify patients who benefit from such treatment.
PATIENTS AND METHODS


In the NeoAva phase II clinical trial, patients (N = 132) with large (≥ 25 mm) human epidermal growth factor receptor 2 (HER2)-negative primary tumors were randomly assigned 1:1 to treatment with neoadjuvant chemotherapy (CTx) alone or in combination with bevacizumab (Bev plus CTx). The ratio of the tumor size after relative to before treatment was calculated into a continuous response scale. Tumor biopsies taken prior to neoadjuvant treatment were analyzed by reverse-phase protein arrays (RPPA) for expression levels of 210 BC-relevant (phospho-) proteins. Lasso regression was used to derive a predictor of tumor shrinkage from the expression of selected proteins prior to treatment.
RESULTS


We identified a nine-protein signature score named vascular endothelial growth factor inhibition response predictor (ViRP) for use in the Bev plus CTx treatment arm able to predict with accuracy pathologic complete response (pCR) (area under the curve [AUC] = 0.85; 95% CI, 0.74 to 0.97) and low residual cancer burden (RCB 0/I) (AUC = 0.80; 95% CI, 0.68 to 0.93). The ViRP score was significantly lower in patients with pCR ( P  < .001) and in patients with low RCB ( P  < .001). The ViRP score was internally validated on mRNA data and the resultant surrogate mRNA ViRP score significantly separated the pCR patients ( P  = .016). Similarly, the mRNA ViRP score was validated ( P  < .001) in an independent phase II clinical trial (PROMIX).
CONCLUSION


Our ViRP score, integrating the expression of nine proteins and validated on mRNA data both internally and in an independent clinical trial, may be used to increase the likelihood of benefit from treatment with bevacizumab combined with chemotherapy in patients with HER2-negative BC.",2021,The ViRP score was significantly lower in patients with pCR ( P  < .001) and in patients with low RCB ( P  < .001).,"['patients (N = 132) with large (≥ 25 mm) human epidermal growth factor receptor 2 (HER2)-negative primary tumors', 'HER2-Negative Breast Cancers', 'patients with HER2-negative BC']","['bevacizumab', 'neoadjuvant chemotherapy (CTx) alone or in combination with bevacizumab (Bev plus CTx', 'bevacizumab combined with chemotherapy', 'Neoadjuvant Treatment', 'Chemotherapy and Bevacizumab']","['accuracy pathologic complete response (pCR', 'ViRP score', 'surrogate mRNA ViRP score', 'mRNA ViRP score', 'vascular endothelial growth factor inhibition response predictor (ViRP', 'ratio of the tumor size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}]",132.0,0.0563807,The ViRP score was significantly lower in patients with pCR ( P  < .001) and in patients with low RCB ( P  < .001).,"[{'ForeName': 'Mads H', 'Initials': 'MH', 'LastName': 'Haugen', 'Affiliation': 'Department of Tumor Biology, Institute for Cancer Research, Division of Cancer Medicine, Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Ole Christian', 'Initials': 'OC', 'LastName': 'Lingjærde', 'Affiliation': 'Department of Genetics, Institute for Cancer Research, Division of Cancer Medicine, Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Hedenfalk', 'Affiliation': 'Department of Clinical Sciences, Division of Oncology and Pathology, Lund University, Lund, Sweden.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Garred', 'Affiliation': 'Division of Laboratory Medicine-Pathology, Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Borgen', 'Affiliation': 'Division of Laboratory Medicine-Pathology, Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Loman', 'Affiliation': 'Department of Clinical Sciences, Division of Oncology and Pathology, Lund University, Lund, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hatschek', 'Affiliation': 'Department of Oncology-Pathology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anne-Lise', 'Initials': 'AL', 'LastName': 'Børresen-Dale', 'Affiliation': 'Department of Genetics, Institute for Cancer Research, Division of Cancer Medicine, Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Naume', 'Affiliation': 'Institute for Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Gordon B', 'Initials': 'GB', 'LastName': 'Mills', 'Affiliation': 'Department of Cell, Developmental and Cancer Biology, School of Medicine, Oregon Health Science University, Portland, OR.'}, {'ForeName': 'Gunhild M', 'Initials': 'GM', 'LastName': 'Mælandsmo', 'Affiliation': 'Department of Tumor Biology, Institute for Cancer Research, Division of Cancer Medicine, Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Engebraaten', 'Affiliation': 'Department of Tumor Biology, Institute for Cancer Research, Division of Cancer Medicine, Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway.'}]",JCO precision oncology,['10.1200/PO.20.00086']
815,34060185,Speechreading in hearing children can be improved by training.,"Visual information conveyed by a speaking face aids speech perception. In addition, children's ability to comprehend visual-only speech (speechreading ability) is related to phonological awareness and reading skills in both deaf and hearing children. We tested whether training speechreading would improve speechreading, phoneme blending, and reading ability in hearing children. Ninety-two hearing 4- to 5-year-old children were randomised into two groups: business-as-usual controls, and an intervention group, who completed three weeks of computerised speechreading training. The intervention group showed greater improvements in speechreading than the control group at post-test both immediately after training and 3 months later. This was the case for both trained and untrained words. There were no group effects on the phonological awareness or single-word reading tasks, although those with the lowest phoneme blending scores did show greater improvements in blending as a result of training. The improvement in speechreading in hearing children following brief training is encouraging. The results are also important in suggesting a hypothesis for future investigation: that a focus on visual speech information may contribute to phonological skills, not only in deaf children but also in hearing children who are at risk of reading difficulties. A video abstract of this article can be viewed at https://www.youtube.com/watch?v=bBdpliGkbkY.",2021,The intervention group showed greater improvements in speechreading than the control group at post-test both immediately after training and 3 months later.,"['Ninety-two hearing 4- to 5-year-old children', 'hearing children']","['business-as-usual controls, and an intervention group, who completed three weeks of computerised speechreading training']",['phonological awareness or single-word reading tasks'],"[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0023844', 'cui_str': 'Speechreading'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",92.0,0.0130355,The intervention group showed greater improvements in speechreading than the control group at post-test both immediately after training and 3 months later.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Buchanan-Worster', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'Department of Education, Oxford University, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dennan', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Mairéad', 'Initials': 'M', 'LastName': 'MacSweeney', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}]",Developmental science,['10.1111/desc.13124']
816,34432984,Audiologist-Supported Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States: A Pilot Trial.,"Background Patients often report that living with a condition such as tinnitus can be debilitating, worrying, and frustrating. Efficient ways to foster management strategies for individuals with tinnitus and promoting tinnitus self-efficacy are needed. Internet-based cognitive behavioral therapy (ICBT) for tinnitus shows promise as an evidence-based intervention in Europe, but is not available in the United States. The aim of this pilot study was to evaluate the feasibility of an ICBT intervention for tinnitus in the United States. Method This study reports the Phase 1 trial intended to support implementation of a larger randomized clinical trial (RCT) comparing ICBT to a weekly monitoring group. As a pilot study, a single-group pretest-posttest design was used to determine outcome potential, recruitment strategy, retention, and adherence rates of ICBT for tinnitus. The primary outcome was a change in tinnitus distress. Secondary outcome measures included measures of anxiety, depression, insomnia, tinnitus cognitions, hearing-related difficulties, and quality of life. Results Of the 42 screened participants, nine did not meet the inclusion criteria and six withdrew. There were 27 participants who completed the intervention, with a mean age of 55.48 (± 9.9) years. Feasibility was established, as a large pretest-posttest effect size of  d  = 1.6 was found for tinnitus severity. Large pretest-posttest effect sizes were also found for tinnitus cognitions and hearing-related effects, and a medium effect was found for insomnia and quality of life. Treatment adherence varied with a retention rate of 85% ( n  = 23) at post-intervention assessment and 67% ( n  = 18) for the follow-up assessment. Conclusions This pilot study supported the feasibility of ICBT for tinnitus in the United States. Ways of improving intervention retention and recruitment rates need to be explored in future ICBT studies. Protocol refinements that were identified will be implemented prior to further RCTs to investigate the efficacy of ICBT for tinnitus in the United States. Supplemental Material https://doi.org/10.23641/asha.15501135.",2021,Treatment adherence varied with a retention rate of 85% ( n  = 23) at post-intervention assessment and 67% ( n  = 18) for the follow-up assessment.,"['27 participants who completed the intervention, with a mean age of 55.48 (± 9.9) years', 'individuals with tinnitus', '42 screened participants, nine did not meet the inclusion criteria and six withdrew']","['Internet-based cognitive behavioral therapy (ICBT', 'ICBT intervention', 'Audiologist-Supported Internet-Based Cognitive Behavioral Therapy', 'ICBT', 'Supplemental Material https://doi.org/10.23641/asha.15501135']","['tinnitus cognitions and hearing-related effects', 'measures of anxiety, depression, insomnia, tinnitus cognitions, hearing-related difficulties, and quality of life', 'change in tinnitus distress', 'insomnia and quality of life']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0175838', 'cui_str': 'Audiologist'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",27.0,0.0400508,Treatment adherence varied with a retention rate of 85% ( n  = 23) at post-intervention assessment and 67% ( n  = 18) for the follow-up assessment.,"[{'ForeName': 'Eldré W', 'Initials': 'EW', 'LastName': 'Beukes', 'Affiliation': 'Department of Speech and Hearing Sciences, Lamar University, Beaumont, TX.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Department of Biomedical and Clinical Sciences, Linköping University, Sweden.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fagelson', 'Affiliation': 'Department of Audiology and Speech-Language Pathology, East Tennessee State University, Johnson City.'}, {'ForeName': 'Vinaya', 'Initials': 'V', 'LastName': 'Manchaiah', 'Affiliation': 'Department of Speech and Hearing Sciences, Lamar University, Beaumont, TX.'}]",American journal of audiology,['10.1044/2021_AJA-20-00222']
817,34094511,A higher-protein nut-based snack product suppresses glycaemia and decreases glycaemic response to co-ingested carbohydrate in an overweight prediabetic Asian Chinese cohort: the Tū Ora postprandial RCT.,"Nut-based products may aid low-glycaemic dietary strategies that are important for diabetes prevention in populations at increased risk of dysglycaemia, such as Asian Chinese. This randomised cross-over trial assessed the postprandial glycaemic response (0-120 min) of a higher-protein nut-based (HP-NB) snack formulation, in bar format (1009 kJ, Nutrient Profiling Score, NPS, -2), when compared with an iso-energetic higher-carbohydrate (CHO) cereal-based bar (HC-CB, 985 kJ, NPS +3). It also assessed the ability to suppress glucose response to a typical CHO-rich food (white bread, WB), when co-ingested. Ten overweight prediabetic Chinese adults (mean, sd: age 47⋅9, 15⋅7 years; BMI 25⋅5, 1⋅6 kg/m 2 ), with total body fat plus ectopic pancreas and liver fat quantified using dual-energy X-ray absorptiometry and magnetic resonance imaging and spectroscopy, received the five meal treatments in random order: HP-NB, HC-CB, HP-NB + WB (50 g available CHO), HC-CB + WB and WB only. Compared with HC-CB, HP-NB induced a significantly lower 30-120 min glucose response ( P  < 0⋅05), with an approximately 10-fold lower incremental area under the glucose curve (iAUC 0-120 ;  P  < 0⋅001). HP-NB also attenuated glucose response by approximately 25 % when co-ingested with WB ( P  < 0⋅05). Half of the cohort had elevated pancreas and/or liver fat, with 13-21 % greater suppression of iAUC 0-120  glucose in the low  v.  high organ fat subgroups across all five treatments. A nut-based snack product may be a healthier alternative to an energy equivalent cereal-based product with evidence of both a lower postprandial glycaemic response and modulation of CHO-induced hyperglycaemia even in high-risk, overweight, pre-diabetic adults.",2021,HP-NB also attenuated glucose response by approximately 25 % when co-ingested with WB ( P  < 0⋅05).,"['Ten overweight prediabetic Chinese adults (mean, sd: age 47⋅9, 15⋅7 years; BMI 25⋅5, 1⋅6 kg/m 2 ), with total body fat plus ectopic pancreas and liver fat quantified using dual-energy X-ray absorptiometry and magnetic resonance imaging and spectroscopy, received the five meal treatments in random order']","['higher-protein nut-based (HP-NB) snack formulation', 'HP-NB, HC-CB, HP-NB + WB (50 g available CHO), HC-CB + WB and WB only']","['HP-NB induced a significantly lower 30-120 min glucose response', 'glucose response', 'postprandial glycaemic response', 'glycaemic response']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}]",10.0,0.0262401,HP-NB also attenuated glucose response by approximately 25 % when co-ingested with WB ( P  < 0⋅05).,"[{'ForeName': 'Louise W', 'Initials': 'LW', 'LastName': 'Lu', 'Affiliation': 'Human Nutrition Unit, School of Biological Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Marta P', 'Initials': 'MP', 'LastName': 'Silvestre', 'Affiliation': 'Human Nutrition Unit, School of Biological Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ivana R', 'Initials': 'IR', 'LastName': 'Sequeira', 'Affiliation': 'Human Nutrition Unit, School of Biological Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Lindsay D', 'Initials': 'LD', 'LastName': 'Plank', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Meika', 'Initials': 'M', 'LastName': 'Foster', 'Affiliation': 'Edible Research Ltd, Christchurch, New Zealand.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Middleditch', 'Affiliation': 'High-Value Nutrition National Science Challenge, Auckland, New Zealand.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Acevedo-Fani', 'Affiliation': 'High-Value Nutrition National Science Challenge, Auckland, New Zealand.'}, {'ForeName': 'Kieren G', 'Initials': 'KG', 'LastName': 'Hollingsworth', 'Affiliation': 'Newcastle Magnetic Resonance Centre, Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Sally D', 'Initials': 'SD', 'LastName': 'Poppitt', 'Affiliation': 'Human Nutrition Unit, School of Biological Sciences, University of Auckland, Auckland, New Zealand.'}]",Journal of nutritional science,['10.1017/jns.2021.20']
818,34100976,Pulsed electromagnetic field (PEMF) as an adjunct therapy for pain management in interstitial cystitis/bladder pain syndrome.,"INTRODUCTION AND HYPOTHESIS


Patients with interstitial cystitis/bladder pain syndrome (IC/BPS) often experience chronic pelvic and even systemic pain that can be difficult to clinically manage. Pulsed electromagnetic field (PEMF) therapy, a non-invasive strategy that has shown significant efficacy for pain reduction in other chronic pain conditions, may provide benefit for pain management in patients with IC/BPS.
METHODS


PEMF delivery to patients occurs via a bio-electromagnetic-energy device which consists of a flexible mat (180 × 50 cm) that the patient lies on for systemic, full-body delivery and/or a flexible pad (50 × 15 cm) for targeted delivery to a specific body region (e.g., pelvic area). The duration of individual sessions, number of sessions per day, total number of sessions, and follow-up observation period vary between previously published studies. Positive outcomes are typically reported as a significant reduction in visual analog scale (VAS) pain score and functional improvement assessed using validated questionnaires specific to the condition under study.
RESULTS AND CONCLUSIONS


The use of PEMF has been evaluated as a therapeutic strategy for pain management in several clinical scenarios. Randomized, double-blinded, placebo-controlled trials have reported positive efficacy and safety profiles when PEMF was used to treat non-specific low back pain, patellofemoral pain syndrome, chronic post-operative pain, osteoarthritis-related pain, rheumatoid arthritis-related pain, and fibromyalgia-related pain. Based on these positive outcomes in a variety of pain conditions, clinical trials to evaluate whether PEMF can provide a safe, non-invasive therapeutic approach to improve symptoms of chronic pain and fatigue in patients with IC/BPS are warranted.",2022,"The duration of individual sessions, number of sessions per day, total number of sessions, and follow-up observation period vary between previously published studies.","['patients occurs via a bio-electromagnetic-energy device which consists of a flexible mat (180\u2009×\u200950\xa0cm) that the patient lies on for systemic, full-body delivery and/or a flexible pad (50\u2009×\u200915\xa0cm) for targeted delivery to a specific body region (e.g., pelvic area', 'Patients with interstitial cystitis/bladder pain syndrome (IC/BPS', 'patients with IC/BPS', 'interstitial cystitis/bladder pain syndrome']","['Pulsed electromagnetic field (PEMF', 'placebo', 'PEMF', 'Pulsed electromagnetic field (PEMF) therapy']","['duration of individual sessions, number of sessions per day, total number of sessions', 'chronic pain and fatigue', 'visual analog scale (VAS) pain score and functional improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0005898', 'cui_str': 'Body region structure'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.175485,"The duration of individual sessions, number of sessions per day, total number of sessions, and follow-up observation period vary between previously published studies.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ross', 'Affiliation': 'Wake Forest Institute for Regenerative Medicine, Wake Forest Baptist Medical Center, 391 Technology Way, Winston Salem, NC, 27101, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Overholt', 'Affiliation': 'Department of Urology/Female Pelvic Health, Wake Forest Baptist Medical Center, Winston-Salem, NC, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Urology/Female Pelvic Health, Wake Forest Baptist Medical Center, Winston-Salem, NC, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Badlani', 'Affiliation': 'Department of Urology/Female Pelvic Health, Wake Forest Baptist Medical Center, Winston-Salem, NC, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Evans', 'Affiliation': 'Department of Urology/Female Pelvic Health, Wake Forest Baptist Medical Center, Winston-Salem, NC, USA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Matthews', 'Affiliation': 'Department of Urology/Female Pelvic Health, Wake Forest Baptist Medical Center, Winston-Salem, NC, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Walker', 'Affiliation': 'Wake Forest Institute for Regenerative Medicine, Wake Forest Baptist Medical Center, 391 Technology Way, Winston Salem, NC, 27101, USA. swalker@wakehealth.edu.'}]",International urogynecology journal,['10.1007/s00192-021-04862-3']
819,34432899,A Phase 1 Trial to Evaluate the Relationship Between Fluoride Intake and Urinary Fluoride Excretion in Healthy Participants.,"Chronic overexposure to fluoride can have deleterious effects in the musculoskeletal system. Some fluorine-containing therapeutics, such as voriconazole, release fluoride through metabolism. Therefore, drug-related fluoride exposure should be assessed for novel therapeutics suspected of releasing fluoride through metabolism. Two trials were conducted to identify the optimal method of assessing drug-related fluoride exposure. In trial 1, designed to assess reproducibility of fluoride pharmacokinetics in urine and plasma, 14 participants were administered a fluoride-restricted diet and once-daily doses of sodium fluoride (2.2 mg [1 mg of fluoride] on days 1 and 2; and 13.2 mg of sodium fluoride [6 mg of fluoride] on days 3 and 4). In trial 2, designed to confirm the selected method for fluoride detection, 12 participants were administered a fluoride-restricted diet and randomized to receive voriconazole (400 mg twice, 12 hours apart, on day 1 [131 mg/d of fluoride maximum], then 3 doses of 200 mg every 12 hours [65.3 mg/d of fluoride maximum]) or placebo. Plasma fluoride concentrations and urinary fluoride excretion were assessed in each trial. Assessment of plasma fluoride concentrations in trial 1 was limited by 301 of 854 samples (35.2%) below the lower limit of quantitation. Urine fluoride excretion was readily measured and demonstrated a decrease from baseline during the fluoride-restricted diet phase, as well as dose-proportional increases with fluoride administration. In trial 2, increases in urine fluoride were successfully observed in participants administered voriconazole. In conclusion, fluoride exposure was optimally assessed by urinary fluoride excretion in conjunction with strict dietary fluoride restrictions, as measurements were consistent and reproducible.",2022,"Urine fluoride excretion was readily measured and demonstrated a decrease from baseline during the fluoride-restricted diet phase, as well as dose-proportional increases with fluoride administration.","['12 participants were administered a', 'urine and plasma, 14 participants', 'Healthy Participants']","['fluoride-restricted diet and randomized to receive voriconazole', 'fluoride-restricted diet and once-daily doses of sodium fluoride (2.2 mg [1 mg fluoride', 'placebo', 'sodium fluoride [6 mg fluoride', 'voriconazole']","['Plasma fluoride concentrations and urinary fluoride excretion', 'urine fluoride', 'plasma fluoride concentrations', 'Urine fluoride excretion']","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0042036', 'cui_str': 'Urine'}]",14.0,0.0573416,"Urine fluoride excretion was readily measured and demonstrated a decrease from baseline during the fluoride-restricted diet phase, as well as dose-proportional increases with fluoride administration.","[{'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Gillespie', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Jackson Rudd', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Saijuan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schaeffer', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Tomek', 'Affiliation': 'Celerion, Lincoln, Nebraska, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Larson', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'S Aubrey', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Iwamoto', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1956']
820,34078408,Planned early delivery for late preterm pre-eclampsia in a low- and middle-income setting: a feasibility study.,"BACKGROUND


Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity globally. Planned delivery between 34 +0  and 36 +6  weeks may reduce adverse pregnancy outcomes but is yet to be evaluated in a low and middle-income setting. Prior to designing a randomised controlled trial to evaluate this in India and Zambia, we carried out a 6-month feasibility study in order to better understand the proposed trial environment and guide development of our intervention.
METHODS


We used mixed methods to understand the disease burden and current management of pre-eclampsia at our proposed trial sites and explore the acceptability of the intervention. We undertook a case notes review of women with pre-eclampsia who delivered at the proposed trial sites over a 3-month period, alongside facilitating focus group discussions with women and partners and conducting semi-structured interviews with healthcare providers. Descriptive statistics were used to analyse audit data. A thematic framework analysis was used for qualitative data.
RESULTS


Case notes data (n = 326) showed that in our settings, 19.5% (n = 44) of women with pre-eclampsia delivering beyond 34 weeks experienced an adverse outcome. In women delivering between 34 +0  and 36 +6  weeks, there were similar numbers of antenatal stillbirths [n = 3 (3.3%)] and neonatal deaths [n = 3 (3.4%)]; median infant birthweight was 2.2 kg and 1.9 kg in Zambia and India respectively. Lived experience of women and healthcare providers was an important facilitator to the proposed intervention, highlighting the serious consequences of pre-eclampsia. A preference for spontaneous labour and limited neonatal resources were identified as potential barriers.
CONCLUSIONS


This study demonstrated a clear need to evaluate the intervention and highlighted several challenges relating to trial context that enabled us to adapt our protocol and design an acceptable intervention. Our study demonstrates the importance of assessing feasibility when developing complex interventions, particularly in a low-resource setting. Additionally, it provides a unique insight into the management of pre-eclampsia at our trial settings and an understanding of the knowledge, attitudes and beliefs underpinning the acceptability of planned early delivery.",2021,"In women delivering between 34 +0  and 36 +6  weeks, there were similar numbers of antenatal stillbirths [n = 3 (3.3%)] and neonatal deaths [n = 3 (3.4%)]; median infant birthweight was 2.2 kg and 1.9 kg in Zambia and India respectively.","['women with pre-eclampsia who delivered at the proposed trial sites over a 3-month period, alongside facilitating focus group discussions with women and partners and conducting semi-structured interviews with healthcare providers']",[],"['adverse pregnancy outcomes', 'neonatal deaths', 'median infant birthweight', 'adverse outcome', 'numbers of antenatal stillbirths']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",[],"[{'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}]",,0.0783216,"In women delivering between 34 +0  and 36 +6  weeks, there were similar numbers of antenatal stillbirths [n = 3 (3.3%)] and neonatal deaths [n = 3 (3.4%)]; median infant birthweight was 2.2 kg and 1.9 kg in Zambia and India respectively.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Beardmore-Gray', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK. alice.1.beardmore-gray@kcl.ac.uk.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Vousden', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Sergio A', 'Initials': 'SA', 'LastName': 'Silverio', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Charantimath', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, JNMC, Belagavi, Karnataka, India.""}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Katageri', 'Affiliation': ""BVV Sangha's S Nijalingappa Medical College and HSK Hospital and Research Centre, Bagalkot, Karnataka, India.""}, {'ForeName': 'Mrutyunjaya', 'Initials': 'M', 'LastName': 'Bellad', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, JNMC, Belagavi, Karnataka, India.""}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Chinkoyo', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ndola Teaching Hospital, Ndola, Zambia.'}, {'ForeName': 'Bellington', 'Initials': 'B', 'LastName': 'Vwalika', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Shivaprasad', 'Initials': 'S', 'LastName': 'Goudar', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, JNMC, Belagavi, Karnataka, India.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}]",Reproductive health,['10.1186/s12978-021-01159-y']
821,34099544,Low-dose thrombolysis for submassive pulmonary embolism.,"The role of thrombolysis in submassive pulmonary embolism (PE) is controversial due to the high risk of hemorrhage. This study aimed to evaluate the role of half-dose tissue-type plasminogen activator (rt-PA) in preventing death/hemodynamic decompensation in submassive (intermediate-risk) PE without increasing the risk of bleeding. In a prospective, non-randomized, open-label, single-center trial, we compared 50 mg rt-PA plus low molecular weight heparin (LMWH) with LMWH in submassive (intermediate-risk) PE. Eligible cases had confirmed pulmonary hypertension on echocardiography, and/or right ventricular cavity expansion and/or interventricular septal deviation on echocardiography, and/or right to left ventricular ratio equal to or greater than 0.9 mm on CT angiography. The primary outcome was death or hemodynamic decompensation within 7 and 30 days after treatment was given. The primary safety outcome was major extracranial bleeding or hemorrhagic stroke within 7 days. Seventy-six patients were included in the study. Total death/hemodynamic decompensation in the first 7 and 30 days was significantly less in the half-dose rt-PA group than in the LMWH group (p=0.028 and p=0.009, respectively). No significant differences were found between the two groups in terms of recurrent embolism and pulmonary hypertension at 6-month follow-up (p=1.000 and p=0.778). There was no intracranial hemorrhage in any of the patients. There were no statistically significant differences between the two groups in terms of major or minor bleeding complications. This trial showed half-dose rt-PA treatment in submassive (intermediate-risk) PE prevented death/hemodynamic decompensation in the first 7-day and 30-day period compared with LMWH treatment without increasing the risk of bleeding.",2021,No significant differences were found between the two groups in terms of recurrent embolism and pulmonary hypertension at 6-month follow-up (p=1.000 and p=0.778).,"['submassive pulmonary embolism', 'submassive pulmonary embolism (PE', 'Seventy-six patients were included in the study', 'Eligible cases had confirmed pulmonary hypertension on echocardiography, and/or right ventricular cavity expansion and/or interventricular septal deviation on echocardiography, and/or right to left ventricular ratio equal to or greater than 0.9 mm on CT angiography']","['Low-dose thrombolysis', 'half-dose tissue-type plasminogen activator (rt-PA', 'LMWH', '50 mg rt-PA plus low molecular weight heparin (LMWH) with LMWH']","['risk of bleeding', 'Total death/hemodynamic decompensation', 'intracranial hemorrhage', 'death or hemodynamic decompensation', 'recurrent embolism and pulmonary hypertension', 'major or minor bleeding complications', 'death/hemodynamic decompensation', 'major extracranial bleeding or hemorrhagic stroke']","[{'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0549397', 'cui_str': 'Deviated nasal septum'}, {'cui': 'C0445232', 'cui_str': 'Right to left'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0580586', 'cui_str': 'Extracranial'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}]",76.0,0.0279475,No significant differences were found between the two groups in terms of recurrent embolism and pulmonary hypertension at 6-month follow-up (p=1.000 and p=0.778).,"[{'ForeName': 'Emine Serap', 'Initials': 'ES', 'LastName': 'Yilmaz', 'Affiliation': 'Pulmonary Medicine, Ordu University Faculty of Medicine, Training and Research Hospital, Ordu, Turkey serapenderyilmaz@gmail.com.'}, {'ForeName': 'Oğuz', 'Initials': 'O', 'LastName': 'Uzun', 'Affiliation': 'Pulmonary Medicine, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}]",Journal of investigative medicine : the official publication of the American Federation for Clinical Research,['10.1136/jim-2021-001816']
822,34115162,Methenamine hippurate compared with trimethoprim for the prevention of recurrent urinary tract infections: a randomized clinical trial.,"INTRODUCTION AND HYPOTHESIS


The objective was to find an alternative treatment to a low-dose antibiotic for the prevention of recurrent urinary tract infections (UTI) and to evaluate the difference in rates of reinfection within 1 year when treated with methenamine hippurate for prophylaxis compared with trimethoprim.
METHODS


We present a non-blinded randomized trial comparing methenamine hippurate with trimethoprim for the prevention of recurrent UTI at 12 months after starting treatment. Women over 18 who had at least two culture-positive UTI in the prior 6 months or three in the prior year were included. Ninety-two patients met enrollment criteria and were randomized to receive daily prophylaxis with methenamine hippurate or trimethoprim for a minimum of 6 months. Both intent-to-treat and per-protocol analyses if patients received the alternative drug after randomization were analyzed using Student's t test, Mann-Whitney U test, Kaplan-Meier curves, log-rank test, and a logistic and multivariate regression model. The primary outcome of this study was culture-proven UTI recurrence by 12 months after initiating prophylaxis.
RESULTS


In the intent-to-treat analysis, we found no difference between groups in recurrent UTI, with a 65% (28 out of 43) recurrence in the trimethoprim group versus 65% (28 out of 43) in the methenamine hippurate group (p = 1.00). In the per-protocol analysis, 65% (26 out of 40) versus 65% (30 out of 46) of patients had UTI recurrences in the trimethoprim group versus the methenamine hippurate group (p = 0.98).
CONCLUSIONS


Methenamine hippurate may be an alternative for the prevention of recurrent UTI, with similar rates of recurrence and adverse effects to trimethoprim.",2022,"CONCLUSIONS


Methenamine hippurate may be an alternative for the prevention of recurrent UTI, with similar rates of recurrence and adverse effects to trimethoprim.","['Women over 18 who had at least two culture-positive UTI in the prior 6\xa0months or three in the prior year were included', 'Ninety-two patients met enrollment criteria', 'recurrent urinary tract infections']","['trimethoprim', 'daily prophylaxis with methenamine hippurate or trimethoprim', 'methenamine hippurate with trimethoprim', 'Methenamine hippurate']","['culture-proven UTI recurrence', 'rates of reinfection', 'UTI recurrences']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0159125', 'cui_str': 'Culture positive'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0262655', 'cui_str': 'Recurrent urinary tract infection'}]","[{'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0066105', 'cui_str': 'Methenamine hippurate'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205339', 'cui_str': 'Reinfection'}]",43.0,0.476955,"CONCLUSIONS


Methenamine hippurate may be an alternative for the prevention of recurrent UTI, with similar rates of recurrence and adverse effects to trimethoprim.","[{'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Botros', 'Affiliation': 'Lehigh Valley Health Network, 1611 Pond Road, Allentown, PA, 18104, USA. carolynbotros@gmail.com.'}, {'ForeName': 'Svjetlana', 'Initials': 'S', 'LastName': 'Lozo', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Iyer', 'Affiliation': 'University of Chicago Medicine, Chicago, IL, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Warren', 'Affiliation': 'Central Michigan University College of Medicine, Mount Pleasant, MI, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Goldberg', 'Affiliation': 'NorthShore University Health System, Skokie, IL, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Tomezsko', 'Affiliation': ""Women's Health Institute of Illinois, Skokie, IL, USA.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sasso', 'Affiliation': ""Women's Health Institute of Illinois, Skokie, IL, USA.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sand', 'Affiliation': 'NorthShore University Health System, Skokie, IL, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gafni-Kane', 'Affiliation': 'NorthShore University Health System, Skokie, IL, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Biener', 'Affiliation': 'Lafayette College, Easton, PA, USA.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Botros-Brey', 'Affiliation': 'University of Texas Health Science Center San Antonio, San Antonio, TX, USA.'}]",International urogynecology journal,['10.1007/s00192-021-04849-0']
823,34433220,An Efficacy Study between High Viscosity Glass Ionomers and Resin Sealants in Fissure Caries Prevention: A 2-Year Split Mouth Randomized Controlled Trial.,"OBJECTIVES


This clinical trial compared the efficacy of atraumatic restorative treatment (ART) sealants against resin-based sealants in terms of their retention and fissure caries preventive benefits over a period of 24 months among a section of school children in the Southern Indian state of Telangana.
MATERIALS AND METHODS


A split mouth clinical trial employed 198 children, who received these sealants on their lower permanent first molars. Retention was assessed 6 monthly and caries annually STATISTICAL ANALYSIS:  Chi-square tests were utilized to analyze the retention rate and the incidence of dental caries between the two groups. Kaplan-Meier survival analysis plotted the cumulative survival percentage of partially, and fully retained sealants and the survival of dentin carious free pits and fissures among both the groups. A linear binary logistical regression analysis calculated the odds ratio.
RESULTS


A statistical significant difference was observed in the retention rate between these sealants at every follow-up stage. The cumulative survival percentage of ART and resin sealants was calculated to be 30.9 and 37.5% by the end of 2 years. The Kaplan-Meier analysis showed no significant difference with regard to the survival of dentin carious free pits and fissures. The odds ratio for this trial was 0.747 (95% confidence interval: 0.493-1.13) CONCLUSION:  Resin sealants fared better than ART sealants in the field of retention. However, no significant differences were observed with regard to fissure caries prevention by the end of the study period.",2022,The Kaplan-Meier analysis showed no significant difference with regard to the survival of dentin carious free pits and fissures.,"['Fissure Caries Prevention', 'school children in the Southern Indian state of Telangana', '198 children, who received these sealants on their lower permanent first molars']","['atraumatic restorative treatment (ART) sealants against resin-based sealants', 'ART sealants', 'High Viscosity Glass Ionomers and Resin Sealants']","['cumulative survival percentage of ART and resin sealants', 'survival of dentin carious free pits and fissures', 'fissure caries prevention', 'retention rate and the incidence of dental caries', 'retention rate']","[{'cui': 'C0332469', 'cui_str': 'Fissure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0061297', 'cui_str': 'glass ionomer'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0175697', 'cui_str': 'Van der Woude syndrome'}, {'cui': 'C0332469', 'cui_str': 'Fissure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",198.0,0.198464,The Kaplan-Meier analysis showed no significant difference with regard to the survival of dentin carious free pits and fissures.,"[{'ForeName': 'Praveen Bhoopathi', 'Initials': 'PB', 'LastName': 'Haricharan', 'Affiliation': 'Dental Public Health Unit, Faculty of Dentistry, Asian Institute of Medicine, Science and Technology University, Bedong, Kedah, Malaysia.'}, {'ForeName': 'Sreenivas', 'Initials': 'S', 'LastName': 'Voruganti', 'Affiliation': 'Department of Public Health Dentistry, Kamineni Institute of Dental Sciences, Telangana, India.'}, {'ForeName': 'Arpitha', 'Initials': 'A', 'LastName': 'Kotha', 'Affiliation': 'Department of Public Health Dentistry, MNR Dental College & Hospital, Telangana, India.'}, {'ForeName': 'Madhuniranjanswamy', 'Initials': 'M', 'LastName': 'Mahalakshmamma Shivanna', 'Affiliation': 'Department of Community Dentistry, Penang International Dental College, Butterworth, Penang, Malaysia.'}, {'ForeName': 'Bhavana', 'Initials': 'B', 'LastName': 'Gandhi', 'Affiliation': 'Faculty of Dentistry, AIMST University, Bedong, Kedah, Malaysia.'}, {'ForeName': 'Nanditha', 'Initials': 'N', 'LastName': 'Suresh', 'Affiliation': 'Department of Periodontology, Asean memorial dental college and hospital, Tamil Nadu, Chennai, India.'}]",European journal of dentistry,['10.1055/s-0041-1731925']
824,34435467,A Dose-Confirmation Phase 1 Study to Evaluate the Safety and Pharmacology of Glucarpidase in Healthy Volunteers.,"Glucarpidase rapidly decomposes methotrexate. A phase 1 study of glucarpidase in an open-label, randomized parallel group was conducted to evaluate the safety, pharmacokinetics, and other pharmacologic effects in Japanese healthy volunteers without methotrexate treatment. A dose of 50 U/kg (n = 8) or 20 U/kg (n = 8) of glucarpidase was administered as an intravenous injection, with 1 repeated dose at 48 hours after the first dose. No dose-limiting toxicities, no significant clinical examination findings, and no clinically relevant differences between dose levels were observed. The pharmacokinetic parameters at a first dose of 20 or 50 U/kg were similar to those at a second dose and were as follows: half-life, 7.45 and 7.25 hours; area under the plasma concentration-time curve from time 0 to infinity, 8.25 and 19.05 μg·h/mL; total clearance, 4.85 and 5.47 mL/min; and volume of distribution during the elimination phase, 3.12 and 3.41 L, respectively. The area under the plasma concentration-time curve increased in a generally linear dose-proportional manner. An ethnicity specificity in the pharmacokinetic profile was not observed in Japanese volunteers. The serum folate concentration decreased after glucarpidase administration in all the volunteers. The production of anti-glucarpidase antibody was observed in many cases in both cohorts. Although the long-term effect of anti-glucarpidase antibody will need to be investigated in the future, the effects produced by the anti-glucarpidase antibody were not influenced by the pharmacokinetics of glucarpidase within 96 hours after the first dose. The observed safety and tolerability, pharmacokinetics, and pharmacodynamics support the continued evaluation of glucarpidase in the patients with lethal methotrexate toxicities.",2022,"No dose-limiting toxicities, no significant clinical examination findings, and no clinically relevant differences between dose levels were observed.","['patients with lethal methotrexate toxicities', 'Japanese healthy volunteers without methotrexate treatment', 'Healthy Volunteers', 'Japanese volunteers']","['methotrexate', 'glucarpidase']","['safety and tolerability, pharmacokinetics, and pharmacodynamics', 'serum folate concentration', 'production of anti-glucarpidase antibody', 'plasma concentration-time curve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0568062', 'cui_str': 'Methotrexate poisoning'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0007072', 'cui_str': 'glucarpidase'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007072', 'cui_str': 'glucarpidase'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.028224,"No dose-limiting toxicities, no significant clinical examination findings, and no clinically relevant differences between dose levels were observed.","[{'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Fukaya', 'Affiliation': ""Department of Pharmacy, Tokyo Women's Medical University Hospital, Tokyo, Japan.""}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': ""Department of Pharmacy, Tokyo Women's Medical University Hospital, Tokyo, Japan.""}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Center for Integrated Medical Research, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Umemura', 'Affiliation': 'Department of Pharmacology, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kawamoto', 'Affiliation': 'Department of Pediatric Oncology, National Cancer Center Hospital, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.1010']
825,34439206,Behavioral and Psychological Outcomes Associated with Skin Cancer Genetic Testing in Albuquerque Primary Care.,"Public availability of genetic information is increasing; thus, efforts to improve diversity in basic and translational research in genomics is a top priority. Given the increasing U.S. incidence and mortality of melanoma, and the prevalence of common melanocortin-1 receptor ( MC1R)  gene melanoma risk variants in the general population, we examined genomic testing of  MC1R  for skin cancer risk in a randomized controlled trial in Albuquerque, New Mexico primary care. Participants were 48% Hispanic and were randomized 5:1 to a  MC1R  test invitation or usual care. We assessed 3 month sun protection, skin cancer screening, and skin cancer worry outcomes associated with testing, and key effect moderators (e.g., cancer risk perceptions, and skin cancer risk factors). Our findings indicate that the primary outcomes were unchanged by the  MC1R  test offer, test acceptance, and level of risk feedback. Moderator analyses showed that those with lower risk perception, and those with skin that readily tans, significantly increased their sun protection in response to higher than average risk feedback. Risk feedback did not prompt cancer worry, and average risk feedback did not erode existing sun protection. This study paves the way for the development of tailored strategies to address low skin cancer risk awareness in this understudied context of public health genomics.",2021,"Moderator analyses showed that those with lower risk perception, and those with skin that readily tans, significantly increased their sun protection in response to higher than average risk feedback.",['Participants were 48% Hispanic'],['MC1R  test invitation or usual care'],"['sun protection, skin cancer screening, and skin cancer worry outcomes associated with testing, and key effect moderators (e.g., cancer risk perceptions, and skin cancer risk factors', 'MC1R  test offer, test acceptance, and level of risk feedback', 'sun protection']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C2919584', 'cui_str': 'Screening for malignant neoplasm of skin'}, {'cui': 'C0007114', 'cui_str': 'Malignant neoplasm of skin'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",,0.110397,"Moderator analyses showed that those with lower risk perception, and those with skin that readily tans, significantly increased their sun protection in response to higher than average risk feedback.","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Hay', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Kaphingst', 'Affiliation': 'Cancer Communication Research, Huntsman Cancer Center, University of Utah, Salt Lake City, UT 84112, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., Golden, CO 80401, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schofield', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Meyer White', 'Affiliation': 'New Mexico VA Health System, Veterans Health Administration, Albuquerque, NM 87108, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sussman', 'Affiliation': 'Department of Family and Community Medicine, University of New Mexico, Albuquerque, NM 87102, USA.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Guest', 'Affiliation': 'University of New Mexico Comprehensive Cancer Center, Albuquerque, NM 87102, USA.'}, {'ForeName': 'Yvonne T', 'Initials': 'YT', 'LastName': 'Dailey', 'Affiliation': 'University of New Mexico Comprehensive Cancer Center, Albuquerque, NM 87102, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Robers', 'Affiliation': 'University of New Mexico Comprehensive Cancer Center, Albuquerque, NM 87102, USA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Schwartz', 'Affiliation': 'University of New Mexico Comprehensive Cancer Center, Albuquerque, NM 87102, USA.'}, {'ForeName': 'Yuelin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Hunley', 'Affiliation': 'Department of Anthropology, University of New Mexico, Albuquerque, NM 87102, USA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Berwick', 'Affiliation': 'Department of Internal Medicine, University of New Mexico, Albuquerque, NM 87102, USA.'}]",Cancers,['10.3390/cancers13164053']
826,34078323,Rationale and design of the OPTIMIZE trial: OPen label multicenter randomized trial comparing standard IMmunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen In combination with everolimus in de novo renal transplantation in Elderly patients.,"BACKGROUND


In 2019, more than 30 % of all newly transplanted kidney transplant recipients in The Netherlands were above 65 years of age. Elderly patients are less prone to rejection, and death censored graft loss is less frequent compared to younger recipients. Elderly recipients do have increased rates of malignancy and infection-related mortality. Poor kidney transplant function in elderly recipients may be related to both pre-existing (i.e. donor-derived) kidney damage and increased susceptibility to nephrotoxicity of calcineurin inhibitors (CNIs) in kidneys from older donors. Hence, it is pivotal to shift the focus from prevention of rejection to preservation of graft function and prevention of over-immunosuppression in the elderly. The OPTIMIZE study will test the hypothesis that reduced CNI exposure in combination with everolimus will lead to better kidney transplant function, a reduced incidence of complications and improved health-related quality of life for kidney transplant recipients aged 65 years and older, compared to standard immunosuppression.
METHODS


This open label, randomized, multicenter clinical trial will include 374 elderly kidney transplant recipients (≥ 65 years) and consists of two strata. Stratum A includes elderly recipients of a kidney from an elderly deceased donor and stratum B includes elderly recipients of a kidney from a living donor or from a deceased donor < 65 years. In each stratum, subjects will be randomized to a standard, tacrolimus-based immunosuppressive regimen with mycophenolate mofetil and glucocorticoids or an adapted immunosuppressive regimen with reduced CNI exposure in combination with everolimus and glucocorticoids. The primary endpoint is 'successful transplantation', defined as survival with a functioning graft and an eGFR ≥ 30 ml/min per 1.73 m 2  in stratum A and ≥ 45 ml/min per 1.73 m 2  in stratum B, after 2 years, respectively.
CONCLUSIONS


The OPTIMIZE study will help to determine the optimal immunosuppressive regimen after kidney transplantation for elderly patients and the cost-effectiveness of this regimen. It will also provide deeper insight into immunosenescence and both subjective and objective outcomes after kidney transplantation in elderly recipients.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03797196 , registered January 9th, 2019. EudraCT: 2018-003194-10, registered March 19th, 2019.",2021,Elderly recipients do have increased rates of malignancy and infection-related mortality.,"['elderly recipients', '374 elderly kidney transplant recipients (≥\u200965 years) and consists of two strata', 'elderly patients', 'elderly recipients of a kidney from an elderly deceased donor and stratum B includes elderly recipients of a kidney from a living donor or from a deceased donor\u2009<\u200965 years', 'Elderly patients', 'kidney transplant recipients aged 65 years and older', 'Elderly recipients', 'In 2019, more than 30\u2009% of all newly transplanted kidney transplant recipients in The Netherlands were above 65 years of age']","['EudraCT', 'everolimus', 'mycophenolate mofetil and glucocorticoids or an adapted immunosuppressive regimen with reduced CNI exposure in combination with everolimus and glucocorticoids', 'standard IMmunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen']","[""successful transplantation', defined as survival with a functioning graft and an eGFR"", 'rates of malignancy and infection-related mortality']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1431767', 'cui_str': 'cni protein, Drosophila'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",374.0,0.0494077,Elderly recipients do have increased rates of malignancy and infection-related mortality.,"[{'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'de Boer', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. s.e.de.boer@umcg.nl.'}, {'ForeName': 'J S F', 'Initials': 'JSF', 'LastName': 'Sanders', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Bemelman', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, Amsterdam Universal Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'M G H', 'Initials': 'MGH', 'LastName': 'Betjes', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology & Transplantation, Erasmus MC, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'J G M', 'Initials': 'JGM', 'LastName': 'Burgerhof', 'Affiliation': 'Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hilbrands', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kuypers', 'Affiliation': 'Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'van Munster', 'Affiliation': 'Department of Internal Medicine, Divison of Geriatrics, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Nurmohamed', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, Amsterdam Universal Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'A P J', 'Initials': 'APJ', 'LastName': 'de Vries', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology; and Leiden Transplant Center, Leiden University Medical Center, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'van Zuilen', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Hesselink', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology & Transplantation, Erasmus MC, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Berger', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]",BMC nephrology,['10.1186/s12882-021-02409-8']
827,34115244,Closed non-suction drain placement as haematoma and seroma formation preventive measure post-nylon darn surgery for inguinoscrotal hernias in adults.,"PURPOSE


Inguinal hernia is a common male surgical disease. Intervention carries a wide range of complications such as scrotal haematoma and seroma which may require surgical re-intervention or predispose patients to developing infections, pains or feeling of mass. This could lead to long hospital stay. Scrotal tamponade by bandaging or wearing of tight pants and elevation are practiced to reduce bleeding and haematoma formation. These methods require prolong use. Closed suction drains are scarcely used in resource-deprived communities due to high cost and non-availability.
AIM


This study was to determine the effectiveness of a closed non-suction drain in preventing scrotal collection requiring further surgical intervention and the predisposition to developing surgical site infection following nylon darn repair of inguinoscrotal hernia.
METHODS


Forty (40) participants were recruited for a preliminary study and assigned into control and interventional groups (CG, IG) for purposes of inserting flexible feeding tube (FFT) wound drain after nylon darn (ND) repair. Daily measurement of drained scrotal collection was carried out in the IG till the day drainage was zero. Residual volumes in IG and wound collection in the CG who were not candidates for re-intervention were determined at 14th and 28th post-operative days using ultrasound scan. Data were analyzed using SPSS version 25.
RESULTS


Three (3) patients (15.8%) in the CG required re-intervention. Surgical site infection rates for the CG and IG were, respectively, 2/19 versus 0/21 (ρ = 0.134).There was a numerical significant difference in the mean volumes of scrotal collections between the control (0.95 ± 0.42 ml) and the intervention group (0.44 ± 0.33 ml) [p value of 0.041] but with no clinical impact.
CONCLUSION


Simple inexpensive flexible feeding tube placement significantly reduced scrotal collection which forms a base for larger sample size in subsequent studies. This could reduce the feared risk of re-intervention, wound infection and long hospital stay post-operative.",2022,0.134).There was a numerical significant difference in the mean volumes of scrotal collections between the control (0.95 ± 0.42 ml) and the intervention group (0.44 ± 0.33 ml),"['Forty (40', 'inguinoscrotal hernias in adults']","['Closed suction drains', 'closed non-suction drain', 'Closed non-suction drain placement', 'flexible feeding tube (FFT) wound drain after nylon darn (ND) repair']","['Surgical site infection rates', 'scrotal collection', 'mean volumes of scrotal collections']","[{'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0441139', 'cui_str': 'Suction drain'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C2945625', 'cui_str': 'Feeding tube'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0028736', 'cui_str': 'Nylon'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0036471', 'cui_str': 'Scrotal'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",40.0,0.0410166,0.134).There was a numerical significant difference in the mean volumes of scrotal collections between the control (0.95 ± 0.42 ml) and the intervention group (0.44 ± 0.33 ml),"[{'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Hagbevor', 'Affiliation': 'Surgical Unit, Margret Marquart Catholic Hospital, Kpando, Ghana. futagbiisrael@yahoo.com.'}, {'ForeName': 'Mahamudu Ayamba', 'Initials': 'MA', 'LastName': 'Ali', 'Affiliation': 'Department of Surgery, School of Medicine, University of Health and Allied Sciences, Ho, Ghana.'}, {'ForeName': 'George Asare', 'Initials': 'GA', 'LastName': 'Awuku', 'Affiliation': 'Department of Medical Laboratory Sciences, School of Biomedical and Allied Health Sciences, University of Ghana, Korle, Bu, Accra, Ghana.'}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-021-02430-8']
828,34435933,"A randomized trial assessing the efficacy, immunogenicity, and safety of vaccination with live attenuated varicella zoster virus-containing vaccines: ten-year follow-up in Russian children.","In Russia, a universal varicella vaccination (UVV) program has not been implemented, and varicella vaccination coverage is low. We assessed the efficacy, antibody persistence, and safety of one- and two-dose varicella vaccination schedules in Russian children with a ten-year follow-up period, as part of an international phase IIIB, observer-blind, randomized, controlled trial (NCT00226499). Children aged 12-22 months were randomized (3:3:1) to receive two doses of tetravalent measles-mumps-rubella-varicella vaccine (V2 group), one dose trivalent measles-mumps-rubella (MMR) vaccine and one dose of varicella vaccine (V1 group), or two doses of MMR vaccine (V0 [control] group), 42 days apart. Main study outcomes were: vaccine efficacy (VE) against confirmed varicella cases, anti-varicella zoster virus (VZV) seropositivity rates and geometric mean concentrations, and reporting of (serious) adverse events ([S]AEs). The total vaccinated cohort in Russia comprised 1000 children; 900 were followed up until study end (year [Y] 10). VE estimates against confirmed varicella (Y10) were 92.4% in the V2 group and 74.7% in the V1 group. Anti-VZV seropositivity rates remained ≥99.4% in the V2 group and ≥89.7% in the V1 group from day 42 post-vaccination 2 until Y10. Occurrence of (un)solicited AEs and SAEs was similar across groups and confirmed the safety profile of the vaccines. No vaccination-related SAEs or deaths were reported. These results are consistent with the global trial results, i.e., the highest VE estimates observed following the two-dose schedule compared to the one-dose schedule. These data may inform decision-making related to potential implementation of a UVV program.",2021,VE estimates against confirmed varicella (Y10) were 92.4% in the V2 group and 74.7% in the V1 group.,"['Russian children with a ten-year follow-up period, as part of an international phase IIIB', 'Children aged 12-22\xa0months', 'Russian children']","['vaccination with live attenuated varicella zoster virus-containing vaccines', 'tetravalent measles-mumps-rubella-varicella vaccine (V2 group), one dose trivalent measles-mumps-rubella (MMR) vaccine and one dose of varicella vaccine (V1 group), or two doses of MMR vaccine (V0 [control']","['Anti-VZV seropositivity rates', 'efficacy, antibody persistence, and safety', 'efficacy, immunogenicity, and safety', 'vaccine efficacy (VE) against confirmed varicella cases, anti-varicella zoster virus (VZV) seropositivity rates and geometric mean concentrations, and reporting of (serious) adverse events ([S]AEs']","[{'cui': 'C0035967', 'cui_str': 'Russian language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042338', 'cui_str': 'Human herpesvirus 3'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0035920', 'cui_str': 'Rubella'}, {'cui': 'C0078048', 'cui_str': 'Varicella virus vaccine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035923', 'cui_str': 'Rubella virus vaccine'}, {'cui': 'C0065828', 'cui_str': 'Measles, mumps and rubella vaccine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042338', 'cui_str': 'Human herpesvirus 3'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0008049', 'cui_str': 'Varicella'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1000.0,0.284746,VE estimates against confirmed varicella (Y10) were 92.4% in the V2 group and 74.7% in the V1 group.,"[{'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Namazova-Baranova', 'Affiliation': 'Scientific Center of Children Health, Moscow, Russia.'}, {'ForeName': 'Md Ahsan', 'Initials': 'MA', 'LastName': 'Habib', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Povey', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'Efendieva', 'Affiliation': 'Scientific Center of Children Health, Moscow, Russia.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Fedorova', 'Affiliation': 'Regional Children Hospital, Tomsk, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Fedoseenko', 'Affiliation': 'Scientific Center of Children Health, Moscow, Russia.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Ivleva', 'Affiliation': 'Medical Clinicodiagnostic Center Reafan, Novosibirsk, Russia.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Kovshirina', 'Affiliation': 'Regional Children Hospital, Tomsk, Russia.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Levina', 'Affiliation': 'Scientific Center of Children Health, Moscow, Russia.'}, {'ForeName': 'Artem', 'Initials': 'A', 'LastName': 'Lyamin', 'Affiliation': 'Samara State Medical University, Samara, Russia.'}, {'ForeName': 'Ludmila', 'Initials': 'L', 'LastName': 'Ogorodova', 'Affiliation': 'Regional Children Hospital, Tomsk, Russia.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Reshetko', 'Affiliation': 'City outpatient clinic #11, Saratov, Russia.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Romanenko', 'Affiliation': 'Ural State Medical University, Ministry of Health of the Russian Federation, Ekaterinburg, Russia.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Ryzhenkova', 'Affiliation': 'City outpatient clinic #11, Saratov, Russia.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Sidorenko', 'Affiliation': 'Children Moscow city Polyclinic N 118, Moscow, Russia.'}, {'ForeName': 'Yakov', 'Initials': 'Y', 'LastName': 'Yakovlev', 'Affiliation': 'Novokuznetsk Municipal Children Hospital, Novokuznetsk, Russia.'}, {'ForeName': 'Aleksandr', 'Initials': 'A', 'LastName': 'Zhestkov', 'Affiliation': 'Samara State Medical University, Samara, Russia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Tatochenko', 'Affiliation': 'City Children Hospital Named after T.G.Petrova, Ivanteevka Moscow Region, Russia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Scherbakov', 'Affiliation': 'GSK, Moscow, Russia.'}, {'ForeName': 'Evgeniy L', 'Initials': 'EL', 'LastName': 'Shpeer', 'Affiliation': 'GSK, Moscow, Russia.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Casabona', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Nadezhda', 'Initials': 'N', 'LastName': 'Ardentova', 'Affiliation': 'Saratov State Medical University, Saratov, Russia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Deev', 'Affiliation': 'Siberian State Medical University, Tomsk, Russia.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Denisov', 'Affiliation': 'Novosibirsk State University, Novosibirsk, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Galytskaya', 'Affiliation': 'Private Medical Clinic Preamble, Moscow, Russia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gayvoronskaya', 'Affiliation': 'Pirogov National Medical and Surgical Center, Moscow, Russia.'}, {'ForeName': 'Natalia Ivanovna', 'Initials': 'NI', 'LastName': 'Ilina', 'Affiliation': 'National Research Center ""Institute of Immunology"" Federal Medical-Biological Agency of Russia, Moscow, Russia.'}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Karnaukhov', 'Affiliation': ""LLC Medical Center 'Reafan', Novosibirsk, Russia.""}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Karpova', 'Affiliation': 'GSK, Moscow, Russia.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Lutsevich', 'Affiliation': 'City outpatient clinic #11, Saratov, Russia.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Romanova', 'Affiliation': 'Children Hospital N.Ivanova, Samara, Russia.'}, {'ForeName': 'Olga Victorovna', 'Initials': 'OV', 'LastName': 'Rybina', 'Affiliation': ""LLC Medical Center 'Reafan', Novosibirsk, Russia.""}, {'ForeName': 'Alebai', 'Initials': 'A', 'LastName': 'Sabitov', 'Affiliation': 'Ural State Medical University, Ekaterinburg, Russia.'}, {'ForeName': 'Sophia Anatolyevna', 'Initials': 'SA', 'LastName': 'Tsarkova', 'Affiliation': 'FGBOU HE USMU of the Ministry of Health of Russia, Ekaterinburg, Russia.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Zakharzhevskaya', 'Affiliation': 'Children Moscow city Polyclinic N 118, Moscow, Russia.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2021.1959148']
829,34435831,Personalized normative feedback for hazardous drinking among college women: Differential outcomes by history of incapacitated rape.,"OBJECTIVE


Personalized normative feedback (PNF) interventions are effective at reducing hazardous drinking in college. However, little is known about who is most receptive to PNF. College women with a history of alcohol-related incapacitated rape (IR) are at elevated risk for hazardous drinking, but it is unclear what impact intervention messaging may have on this group and how their outcomes compare to those without past IR. To address this gap, this study involved secondary data analysis of a large web-based clinical trial.
METHOD


Heavy drinking college women ( N  = 1,188) were randomized into PNF ( n  = 895) or control conditions ( n  = 293). Postintervention, women reported their reactions to intervention messaging. Hazardous drinking outcomes (typical drinking, heavy episodic drinking [HED], peak estimated blood alcohol content [eBAC], blackout frequency) were assessed at baseline and 12 months.
RESULTS


Past IR was reported by 16.3% ( n  = 194) of women. Women with a history of IR reported more baseline hazardous drinking and greater readiness to change than women without IR. For those who received PNF, history of IR related to greater perceived impact of the intervention, but no difference in satisfaction with the message. After controlling for baseline drinking, regressions revealed the effect of PNF was moderated by IR for frequency of HED at 12 months. Simple main effects revealed PNF was associated with lower levels of hazardous drinking at follow-up among women with past IR.
CONCLUSIONS


This initial investigation suggests PNF is a low resource and easily disseminated intervention that can have a positive impact on college women with past IR. (PsycInfo Database Record (c) 2021 APA, all rights reserved).",2021,"Simple main effects revealed PNF was associated with lower levels of hazardous drinking at follow-up among women with past IR.
","['college women with past IR', 'hazardous drinking among college women', 'Heavy drinking college women', 'College women with a history of alcohol-related incapacitated rape (IR', 'hazardous drinking in college']","['Personalized normative feedback', 'PNF', 'Personalized normative feedback (PNF) interventions']","['Hazardous drinking outcomes (typical drinking, heavy episodic drinking [HED], peak estimated blood alcohol content [eBAC], blackout frequency', 'hazardous drinking']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0034668', 'cui_str': 'Forcible intercourse'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Concentration'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",1188.0,0.0374644,"Simple main effects revealed PNF was associated with lower levels of hazardous drinking at follow-up among women with past IR.
","[{'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Jaffe', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Blayney', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Graupensperger', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Stappenbeck', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Bedard-Gilligan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Larimer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000657']
830,34436943,The Effects of Written Stuttering Disclosure on the Perceptions of a Child Who Stutters.,"Purpose This study measured between-groups differences in perceived speech skills and personality characteristics of a 12-year-old male child who stutters (CWS) as a function of a written factual stuttering disclosure statement, delivered by the CWS, his ""mother,"" or his ""teacher."" Method Four hundred twenty-four college-age adults were assigned to one of four groups, including three experimental groups (i.e., written self-disclosure, mother-written disclosure, and teacher-written disclosure) and a control group (no written disclosure). Participants in the control conditions viewed a brief video of the CWS. In the experimental conditions, participants read a brief written disclosure statement for 30 s, followed by the same video used in the control condition. After viewing the video, all participants completed surveys relative to their perceptions of the CWS speech skills and personality characteristics. Results Results reveal that a written stuttering disclosure statement provided by the mother correlated with select significant desirable perceptual differences of the CWS, while a written disclosure statement provided by the CWS yielded insignificant or even undesirable perceptual differences of the CWS. Written stuttering disclosures provided by a ""teacher"" did not yield any significant between-groups differences in the perception of a CWS. Gender affiliation was found to be a source of covariance in a number of perceived speech skills and personality characteristics. Conclusions Written stuttering disclosure statements provided by the ""mother"" correlated with select favorable perceptual differences of speech skills and personal characteristics of a CWS. Clinically, the application of novel methods (written and oral disclosure statements) and sources (i.e., CWS advocates such as ""mother"" and ""teacher"") of stuttering disclosure statement can be integrated into a systematic therapeutic program, creating an innovative approach of scaffolding self-advocacy via stuttering disclosure in CWS. Supplemental Material https://doi.org/10.23641/asha.15505857.",2021,"Written stuttering disclosures provided by a ""teacher"" did not yield any significant between-groups differences in the perception of a CWS.","['12-year-old male child who stutters (CWS) as a function of a written factual stuttering disclosure statement, delivered by the CWS, his ""mother,"" or his ""teacher', 'Method Four hundred twenty-four college-age adults']","['Written Stuttering Disclosure', 'written self-disclosure, mother-written disclosure, and teacher-written disclosure) and a control group (no written disclosure']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0038506', 'cui_str': 'Stuttering'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0038506', 'cui_str': 'Stuttering'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0036596', 'cui_str': 'Self Disclosure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],424.0,0.068967,"Written stuttering disclosures provided by a ""teacher"" did not yield any significant between-groups differences in the perception of a CWS.","[{'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Snyder', 'Affiliation': 'Department of Communication Sciences & Disorders, The University of Mississippi, Oxford.'}, {'ForeName': 'Ashlee', 'Initials': 'A', 'LastName': 'Manahan', 'Affiliation': 'Department of Communication Sciences & Disorders, The University of Mississippi, Oxford.'}, {'ForeName': 'Peyton', 'Initials': 'P', 'LastName': 'McKnight', 'Affiliation': 'Department of Communication Sciences & Disorders, The University of Mississippi, Oxford.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Kornisch', 'Affiliation': 'Department of Communication Sciences & Disorders, The University of Mississippi, Oxford.'}]","Language, speech, and hearing services in schools",['10.1044/2021_LSHSS-20-00119']
831,34088883,Variability in Submaximal Self-Paced Exercise Bouts of Different Intensity and Duration.,"PURPOSE


Rating of perceived exertion (RPE) as a training-intensity prescription has been extensively used by athletes and coaches. However, individual variability in the physiological response to exercise prescribed using RPE has not been investigated.
METHODS


Twenty well-trained competitive cyclists (male = 18, female = 2, maximum oxygen consumption = 55.07 [11.06] mL·kg-1·min-1) completed 3 exercise trials each consisting of 9 randomized self-paced exercise bouts of either 1, 4, or 8 minutes at RPEs of 9, 13, and 17. Within-athlete variability (WAV) and between-athletes variability (BAV) in power and physiological responses were calculated using the coefficient of variation. Total variability was calculated as the ratio of WAV to BAV.
RESULTS


Increased RPEs were associated with higher power, heart rate, work, volume of expired oxygen (VO2), volume of expired carbon dioxide (VCO2), minute ventilation (VE), deoxyhemoglobin (ΔHHb) (P < .001), and lower tissue saturation index (ΔTSI%) and ΔO2Hb (oxyhaemoglobin; P < .001). At an RPE of 9, shorter durations resulted in lower VO2 (P < .05) and decreased ΔTSI%, and the ΔHHb increased as the duration increased (P < .05). At an RPE of 13, shorter durations resulted in lower VO2, VE, and percentage of maximum oxygen consumption (P < .001), as well as higher power, heart rate, ΔHHb (P < .001), and ΔTSI% (P < .05). At an RPE of 17, power (P < .001) and ΔTSI% (P < .05) increased as duration decreased. As intensity and duration increased, WAV and BAV in power, work, heart rate, VO2, VCO2, and VE decreased, and WAV and BAV in near-infrared spectroscopy increased.
CONCLUSIONS


Self-paced intensity prescriptions of high effort and long duration result in the greatest consistency on both a within- and between-athletes basis.",2021,"At an RPE of 9, shorter durations resulted in lower VO2 (P < .05) and decreased ΔTSI%, and the ΔHHb increased as the duration increased (P < .05).","['Twenty well-trained competitive cyclists (male = 18, female = 2, maximum oxygen consumption =55.07']","['ΔTSI', 'perceived exertion (RPE']","['heart rate, work, volume of expired oxygen (VO2), volume of expired carbon dioxide\xa0(VCO2), minute ventilation\xa0(VE), deoxyhemoglobin (ΔHHb', 'intensity and duration increased, WAV and BAV in power, work, heart rate, VO2, VCO2, and VE decreased, and WAV and BAV', 'lower tissue saturation index (ΔTSI%) and ΔO2Hb (oxyhaemoglobin', 'higher power, heart rate, ΔHHb', 'Total variability', 'ΔTSI', 'lower VO2, VE, and percentage of maximum oxygen consumption', 'lower VO2']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0057437', 'cui_str': 'Deoxyhemoglobin'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",20.0,0.020011,"At an RPE of 9, shorter durations resulted in lower VO2 (P < .05) and decreased ΔTSI%, and the ΔHHb increased as the duration increased (P < .05).","[{'ForeName': 'Ciaran', 'Initials': 'C', 'LastName': ""O'Grady"", 'Affiliation': ''}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Passfield', 'Affiliation': ''}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Hopker', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0785']
832,34100922,Apremilast monotherapy for long-term treatment of active psoriatic arthritis in DMARD-naïve patients.,"OBJECTIVES


Apremilast monotherapy was evaluated up to 5 years in PALACE 4 (fourth PsA Long-term Assessment of Clinical Efficacy study) DMARD-naïve patients with PsA.
METHODS


Patients with active PsA were randomized (1:1:1) to placebo, apremilast 30 mg or apremilast 20 mg twice a day. Placebo patients were rerandomized to apremilast at week 16 or 24. Double-blind apremilast continued to week 52, with a 4-year open-label extension (≤260 weeks of exposure). Analyses through week 260 were based on observed data.
RESULTS


A total of 527 patients were treated. Among patients randomized to apremilast 30 mg at baseline, 45.5% completed week 260. At study end, 24.8% reported conventional synthetic DMARD or steroid use for any reason. At week 260, 65.8%/39.0%/20.3% of apremilast 30 mg patients achieved ACR20/ACR50/ACR70 responses, respectively. PsA sign and symptom improvements were sustained up to week 260 with continued treatment, including reductions in swollen (84.8%) and tender (76.4%) joint counts. Among apremilast 30 mg patients with baseline enthesitis or dactylitis, 71.2% achieved a Maastricht Ankylosing Spondylitis Enthesitis Score of 0 and 95.1% achieved a dactylitis count of 0. Over 50% of patients achieved a HAQ Disability Index minimal clinically important difference (≥0.35). In patients with ≥3% baseline psoriasis-involved body surface area, 60.3% and 47.6% achieved ≥50% and ≥75% improvement in Psoriasis Area and Severity Index scores, respectively. Patients continuing apremilast 20 mg also demonstrated consistent, sustained improvements. The most common adverse events were diarrhoea, nausea, headache, upper respiratory tract infection and nasopharyngitis. No new safety concerns were observed long term.
CONCLUSIONS


Apremilast led to sustained PsA efficacy up to 260 weeks and was well tolerated.
TRIAL REGISTRATION


ClinicalTrials.gov (http://clinicaltrials.gov), NCT01307423.",2022,"No new safety concerns were observed long term.
","['527 patients were treated', 'Patients with active PsA', 'Patients continuing apremilast 20', 'DMARD-naive patients']","['Placebo', 'placebo, apremilast 30\u2009mg or apremilast 20\u2009mg twice daily', 'Apremilast monotherapy']","['Maastricht Ankylosing Spondylitis Enthesitis Score', 'PsA sign/symptom improvements', 'ACR20/ACR50/ACR70 responses', 'diarrhoea, nausea, headache, upper respiratory tract infection and nasopharyngitis', 'tolerated', 'Psoriasis Area and Severity Index scores', 'sustained PsA efficacy']","[{'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1678805', 'cui_str': 'apremilast'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3819585', 'cui_str': 'apremilast 30 MG [Otezla]'}, {'cui': 'C3819586', 'cui_str': 'apremilast 20 MG [Otezla]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1678805', 'cui_str': 'apremilast'}]","[{'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C1282952', 'cui_str': 'Enthesitis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",527.0,0.144446,"No new safety concerns were observed long term.
","[{'ForeName': 'Alvin F', 'Initials': 'AF', 'LastName': 'Wells', 'Affiliation': 'Aurora Rheumatology and Immunotherapy Center, Franklin, WI, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Edwards', 'Affiliation': 'NIHR Clinical Research Facility, University Hospital Southampton, Southampton, UK.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, PA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bird', 'Affiliation': 'Department of Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Guerette', 'Affiliation': 'Global Medical Affairs, Amgen Inc., Thousand Oaks, CA.'}, {'ForeName': 'Nikolay', 'Initials': 'N', 'LastName': 'Delev', 'Affiliation': 'Clinical Development, Celgene Corporation, Summit, NJ.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Paris', 'Affiliation': 'Global Medical Affairs, Amgen Inc., Thousand Oaks, CA.'}, {'ForeName': 'Lichen', 'Initials': 'L', 'LastName': 'Teng', 'Affiliation': 'Global Medical Affairs, Amgen Inc., Thousand Oaks, CA.'}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Aelion', 'Affiliation': 'West Tennessee Research Institute, Jackson, TN, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keab449']
833,34435745,Short- and long-term effects of body weight loss following calorie restriction and gastric bypass on CYP3A-activity - a non-randomized three-armed controlled trial.,"It remains uncertain whether pharmacokinetic changes following Roux-en-Y gastric bypass (RYGB) can be attributed to surgery-induced gastrointestinal alterations per se and/or the subsequent weight loss. The aim was to compare short- and long-term effects of RYGB and calorie restriction on CYP3A-activity, and cross-sectionally compare CYP3A-activity with normal weight to overweight controls using midazolam as probe drug. This three-armed controlled trial included patients with severe obesity preparing for RYGB (n = 41) or diet-induced (n = 41) weight-loss, and controls (n = 18). Both weight-loss groups underwent a 3-week low-energy-diet (<1200 kcal/day) followed by a 6-week very-low-energy-diet or RYGB (both <800 kcal/day). Patients were followed for 2 years, with four pharmacokinetic investigations using semisimultaneous oral and intravenous dosing to determine changes in midazolam absolute bioavailability and clearance, within and between groups. The RYGB and diet groups showed similar weight-loss at week 9 (13 ± 2.4% vs. 11 ± 3.6%), but differed substantially after 2 years (-30 ± 7.0% vs. -3.1 ± 6.3%). At baseline, mean absolute bioavailability and clearance of midazolam were similar in the RYGB and diet groups, but higher compared with controls. On average, absolute bioavailability was unaltered at week 9, but decreased by 40 ± 7.5% in the RYGB group and 32 ± 6.1% in the diet group at year 2 compared with baseline, with no between-group difference. No difference in clearance was observed over time, nor between groups. In conclusion, neither RYGB per se nor weight loss impacted absolute bioavailability or clearance of midazolam short term. Long term, absolute bioavailability was similarly decreased in both groups despite different weight loss, suggesting that the recovered CYP3A-activity is not only dependent on weight-loss through RYGB.",2022,"At baseline, mean absolute bioavailability and clearance of midazolam were similar in the RYGB and diet groups, but higher compared with controls.","['patients with severe obesity preparing for RYGB (n\xa0=\xa041) or diet-induced (n\xa0=\xa041) weight-loss, and controls (n\xa0=\xa018']","['midazolam', 'RYGB and calorie restriction', 'calorie restriction and gastric bypass', 'Roux-en-Y gastric bypass (RYGB']","['mean absolute bioavailability and clearance of midazolam', 'clearance', 'absolute bioavailability', 'weight-loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0122723,"At baseline, mean absolute bioavailability and clearance of midazolam were similar in the RYGB and diet groups, but higher compared with controls.","[{'ForeName': 'Kine Eide', 'Initials': 'KE', 'LastName': 'Kvitne', 'Affiliation': 'Section for Pharmacology and Pharmaceutical Biosciences, Department of Pharmacy, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Robertsen', 'Affiliation': 'Section for Pharmacology and Pharmaceutical Biosciences, Department of Pharmacy, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Skovlund', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, NTNU, Trondheim, Norway.'}, {'ForeName': 'Hege', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Section for Pharmacology and Pharmaceutical Biosciences, Department of Pharmacy, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Krogstad', 'Affiliation': 'Section for Pharmacology and Pharmaceutical Biosciences, Department of Pharmacy, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wegler', 'Affiliation': 'Department of Pharmacy, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Philip Carlo', 'Initials': 'PC', 'LastName': 'Angeles', 'Affiliation': 'Vestfold Hospital Trust, The Morbid Obesity Center, Tønsberg, Norway.'}, {'ForeName': 'Birgit Malene', 'Initials': 'BM', 'LastName': 'Wollmann', 'Affiliation': 'Center for Psychopharmacology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Hole', 'Affiliation': 'Center for Psychopharmacology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Line Kristin', 'Initials': 'LK', 'LastName': 'Johnson', 'Affiliation': 'Vestfold Hospital Trust, The Morbid Obesity Center, Tønsberg, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Sandbu', 'Affiliation': 'Vestfold Hospital Trust, The Morbid Obesity Center, Tønsberg, Norway.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Artursson', 'Affiliation': 'Department of Pharmacy and Science for Life Laboratory, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Karlsson', 'Affiliation': 'Late-stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Andersson', 'Affiliation': 'Research and Early Development, Discovery Sciences, BioPharmaceuticals R&D, AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Tommy B', 'Initials': 'TB', 'LastName': 'Andersson', 'Affiliation': 'DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Jøran', 'Initials': 'J', 'LastName': 'Hjelmesaeth', 'Affiliation': 'Vestfold Hospital Trust, The Morbid Obesity Center, Tønsberg, Norway.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Jansson-Löfmark', 'Affiliation': 'DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Åsberg', 'Affiliation': 'Section for Pharmacology and Pharmaceutical Biosciences, Department of Pharmacy, University of Oslo, Oslo, Norway.'}]",Clinical and translational science,['10.1111/cts.13142']
834,34437784,Triple Therapy for Cystic Fibrosis  Phe508del -Gating and -Residual Function Genotypes.,"BACKGROUND


Elexacaftor-tezacaftor-ivacaftor is a small-molecule cystic fibrosis transmembrane conductance regulator (CFTR) modulator regimen shown to be efficacious in patients with at least one  Phe508del  allele, which indicates that this combination can modulate a single  Phe508del  allele. In patients whose other  CFTR  allele contains a gating or residual function mutation that is already effectively treated with previous CFTR modulators (ivacaftor or tezacaftor-ivacaftor), the potential for additional benefit from restoring Phe508del CFTR protein function is unclear.
METHODS


We conducted a phase 3, double-blind, randomized, active-controlled trial involving patients 12 years of age or older with cystic fibrosis and  Phe508del -gating or  Phe508del -residual function genotypes. After a 4-week run-in period with ivacaftor or tezacaftor-ivacaftor, patients were randomly assigned to receive elexacaftor-tezacaftor-ivacaftor or active control for 8 weeks. The primary end point was the absolute change in the percentage of predicted forced expiratory volume in 1 second (FEV 1 ) from baseline through week 8 in the elexacaftor-tezacaftor-ivacaftor group.
RESULTS


After the run-in period, 132 patients received elexacaftor-tezacaftor-ivacaftor and 126 received active control. Elexacaftor-tezacaftor-ivacaftor resulted in a percentage of predicted FEV 1  that was higher by 3.7 percentage points (95% confidence interval [CI], 2.8 to 4.6) relative to baseline and higher by 3.5 percentage points (95% CI, 2.2 to 4.7) relative to active control and a sweat chloride concentration that was lower by 22.3 mmol per liter (95% CI, 20.2 to 24.5) relative to baseline and lower by 23.1 mmol per liter (95% CI, 20.1 to 26.1) relative to active control (P<0.001 for all comparisons). The change from baseline in the Cystic Fibrosis Questionnaire-Revised respiratory domain score (range, 0 to 100, with higher scores indicating better quality of life) with elexacaftor-tezacaftor-ivacaftor was 10.3 points (95% CI, 8.0 to 12.7) and with active control was 1.6 points (95% CI, -0.8 to 4.1). The incidence of adverse events was similar in the two groups; adverse events led to treatment discontinuation in one patient (elevated aminotransferase level) in the elexacaftor-tezacaftor-ivacaftor group and in two patients (anxiety or depression and pulmonary exacerbation) in the active control group.
CONCLUSIONS


Elexacaftor-tezacaftor-ivacaftor was efficacious and safe in patients with  Phe508del -gating or  Phe508del -residual function genotypes and conferred additional benefit relative to previous CFTR modulators. (Funded by Vertex Pharmaceuticals; VX18-445-104 ClinicalTrials.gov number, NCT04058353.).",2021,"The incidence of adverse events was similar in the two groups; adverse events led to treatment discontinuation in one patient (elevated aminotransferase level) in the elexacaftor-tezacaftor-ivacaftor group and in two patients (anxiety or depression and pulmonary exacerbation) in the active control group.
","['patients with at least one  Phe508del  allele', 'patients 12 years of age or older with cystic fibrosis and  Phe508del -gating or  Phe508del -residual function genotypes']","['elexacaftor-tezacaftor-ivacaftor and 126 received active control', 'elexacaftor-tezacaftor-ivacaftor or active control', 'Elexacaftor-tezacaftor-ivacaftor', 'ivacaftor or tezacaftor-ivacaftor', 'Triple Therapy']","['sweat chloride concentration', 'Cystic Fibrosis Questionnaire-Revised respiratory domain score', 'absolute change in the percentage of predicted forced expiratory volume in 1 second (FEV 1 ', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0855766', 'cui_str': 'Residual function'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}]","[{'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.313216,"The incidence of adverse events was similar in the two groups; adverse events led to treatment discontinuation in one patient (elevated aminotransferase level) in the elexacaftor-tezacaftor-ivacaftor group and in two patients (anxiety or depression and pulmonary exacerbation) in the active control group.
","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Barry', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Mall', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Álvarez', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Colombo', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'de Winter-de Groot', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Fajac', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'McBennett', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'McKone', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Bonnie W', 'Initials': 'BW', 'LastName': 'Ramsey', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Sivagurunathan', 'Initials': 'S', 'LastName': 'Sutharsan', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Taylor-Cousar', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tullis', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ahluwalia', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Lucy S', 'Initials': 'LS', 'LastName': 'Jun', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Moskowitz', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Prieto-Centurion', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Waltz', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Fengjuan', 'Initials': 'F', 'LastName': 'Xuan', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Yaohua', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Rowe', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Polineni', 'Affiliation': ""From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen (S.S.) - all in Germany; Vall d'Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan - both in Milan (C.C.); Wilhelmina Children's Hospital-University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands (K.M.W.-G.); Assistance Publique-Hôpitaux de Paris (AP-HP) Centre-Université de Paris Hôpital Cochin AP-HP, Paris (I.F.); Rainbow Babies and Children's Hospital, Cleveland (K.A.M.); St. Vincent's University Hospital, Dublin (E.F.M.); Seattle Children's Hospital, Seattle (B.W.R.); National Jewish Health, Denver (J.L.T.-C.); St. Michael's Hospital, Toronto (E.T.); Vertex Pharmaceuticals, Boston (N.A., L.S.J., S.M.M., V.P.-C., S.T., D.W., F.X., Y.Z.); the University of Alabama at Birmingham, Birmingham (S.M.R.); and the University of Kansas Medical Center, Kansas City (D.P.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2100665']
835,34448877,[German-language versions of the Tinnitus Functional Index : Comparison of the two validated German-language versions of the Tinnitus Functional Index for Switzerland and Germany].,"BACKGROUND


Two validated German-language versions of the Tinnitus Functional Index (TFI) exist, one for Switzerland and one for Germany. The TFI is considered to be a possible new standard questionnaire for evaluation of tinnitus severity and tinnitus treatment.
OBJECTIVE


Considering the standardization taking place in tinnitus evaluation, our aim was to compare the two German-language TFI versions and to recommend only one TFI version in the German-speaking area.
MATERIALS AND METHODS


The two German-language TFI versions were compared in a multicenter and randomized online questionnaire study with a crossover design.
RESULTS


The total score of the two TFI versions did not differ in the total population. However, when further divided in terms of population and order of presentation of the TFI versions, there were significant differences in some cases, albeit with only moderate effect sizes. This suggests that the two versions are slightly different but still comparable. In factor analysis for the TFI version for Germany, in the entire population as well as in the Swiss population, six factors could be extracted. In contrast, for the German and Swiss TFI versions, only five factors could be extracted in the German population, and for the Swiss TFI version, only five factors in the Swiss population.
CONCLUSION


The two German-language versions of the TFI are well comparable with each other. However, the factor analysis rather argues for use of the TFI version for Germany in the entire German-speaking region.",2022,The total score of the two TFI versions did not differ in the total population.,[],[],['total score of the two TFI versions'],[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",,0.049884,The total score of the two TFI versions did not differ in the total population.,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Peter', 'Affiliation': 'Klinik für Ohren‑, Nasen- Hals- und Gesichtschirurgie, UniversitätsSpital Zürich, Universität Zürich, Frauenklinikstraße\xa024, 8091, Zürich, Schweiz. nicole.peter-siegrist@usz.ch.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kleinjung', 'Affiliation': 'Klinik für Ohren‑, Nasen- Hals- und Gesichtschirurgie, UniversitätsSpital Zürich, Universität Zürich, Frauenklinikstraße\xa024, 8091, Zürich, Schweiz.'}, {'ForeName': 'Ricarda', 'Initials': 'R', 'LastName': 'Lippuner', 'Affiliation': 'Klinik für Ohren‑, Nasen- Hals- und Gesichtschirurgie, UniversitätsSpital Zürich, Universität Zürich, Frauenklinikstraße\xa024, 8091, Zürich, Schweiz.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Boecking', 'Affiliation': 'Tinnituszentrum, Charité\xa0- Universitätsmedizin Berlin, Chariteplatz\xa01, 10117, Berlin, Deutschland.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Brueggemann', 'Affiliation': 'Tinnituszentrum, Charité\xa0- Universitätsmedizin Berlin, Chariteplatz\xa01, 10117, Berlin, Deutschland.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Mazurek', 'Affiliation': 'Tinnituszentrum, Charité\xa0- Universitätsmedizin Berlin, Chariteplatz\xa01, 10117, Berlin, Deutschland.'}]",HNO,['10.1007/s00106-021-01099-w']
836,34448986,A feasibility trial of a digital mindfulness-based intervention to improve asthma-related quality of life for primary care patients with asthma.,"Asthma outcomes remain suboptimal, despite effective pharmacotherapy. Psychological dysfunction (such as anxiety) is common, and associated with poorer outcomes. We evaluated a digital mindfulness programme as an intervention to improve asthma-related quality of life for primary care patients, in a prospectively registered randomized-controlled feasibility study. We offered 'Headspace', a widely-used digital mindfulness intervention, to adults with asthma through 16 UK GP practices. Participants were randomized on a 2:1 basis to the mindfulness intervention, or waitlist control. Participants completed questionnaires (including asthma symptom control, asthma-related quality of life, anxiety, depression) at baseline, 6-week and 3-month follow-up. 116 participants completed primary outcomes at 3-month follow-up: intervention 73 (79%), control 43 (84%). Compared to baseline, the intervention group but not the control group reported significantly improved asthma-related quality of life, with a between-group difference favoring the intervention group that was not significant (Mean difference = 0.15, 95%CI - 0.13 to 0.42). Intervention use varied (ranging from 0 to 192 times) but was generally high. Digital mindfulness interventions are feasible and acceptable adjunct treatments for mild and moderate asthma to target quality of life. Further research should adapt 'generic' mindfulness-based stress-reduction to maximize effectiveness for asthma, and validate our findings in a fully-powered randomized controlled trial.Trial registration Prospectively registered: ISRCTN52212323.",2022,"Compared to baseline, the intervention group but not the control group reported significantly improved asthma-related quality of life, with a between-group difference favoring the intervention group that was not significant (Mean difference = 0.15, 95%CI - 0.13 to 0.42).","['primary care patients with asthma', 'adults with asthma through 16 UK GP practices', 'primary care patients', '116 participants']","['Digital mindfulness interventions', 'digital mindfulness-based intervention', 'digital mindfulness programme', 'mindfulness intervention, or waitlist control']","['questionnaires (including asthma symptom control, asthma-related quality of life, anxiety, depression', 'Psychological dysfunction (such as anxiety', 'asthma-related quality of life']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",116.0,0.0667686,"Compared to baseline, the intervention group but not the control group reported significantly improved asthma-related quality of life, with a between-group difference favoring the intervention group that was not significant (Mean difference = 0.15, 95%CI - 0.13 to 0.42).","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Ainsworth', 'Affiliation': 'Department of Psychology, Faculty of Humanities and Social Sciences, University of Bath, Bath, UK. b.ainsworth@bath.ac.uk.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Stanescu', 'Affiliation': 'School of Psychology, Faculty of Life and Environmental Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Stuart', 'Affiliation': 'Primary Care Research Centre, School of Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Russell', 'Affiliation': ', Southampton, UK.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Liddiard', 'Affiliation': 'Primary Care Research Centre, School of Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ratko', 'Initials': 'R', 'LastName': 'Djukanovic', 'Affiliation': 'NIHR Biomedical Research Centre, University Hospitals Southampton NHS Foundation Trust, Southampton, Hampshire, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Primary Care Research Centre, School of Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.'}]",Journal of behavioral medicine,['10.1007/s10865-021-00249-3']
837,34080761,The implementation of reciprocal imitation training in a Part C early intervention setting: A stepped-wedge pragmatic trial.,"Despite the development of several evidence-based Naturalistic Developmental Behavioral Interventions (NDBIs), very few have been adapted for use in community-based settings. This study examines the implementation of Reciprocal Imitation Training (RIT)-an NDBI-by community Early Intervention (EI; IDEA Part C) providers serving toddlers from birth to 3 years. Of the 87 EI providers enrolled from 9 agencies in 4 counties across Washington State, 66 were included in the current sample. A stepped-wedge design was used to randomly assign counties to the timing of RIT training workshops. Self-report measures of practice and self-efficacy regarding ASD care were collected at baseline (T1, T2) and 6-months and 12-months post-training (T3, T4). At T3 and T4, providers reported on RIT adoption and rated items about RIT feasibility and perceived RIT effectiveness; at T4, they also reported on child characteristics that led to RIT use and modifications. From pre-training to post-training, there were significant increases in providers' self-efficacy in providing services to children with ASD or suspected ASD. At T3 and T4, provider ratings indicated high levels of RIT adoption, feasibility, and perceived RIT effectiveness. At T4, providers indicated that they most commonly: (a) initiated RIT when there were social-communication or motor imitation delays, or an ASD diagnosis; and (b) made modifications to RIT by repeating elements, blending it with other therapies, and loosening its structure. While additional research is needed, RIT may help families get an early start on accessing specialized treatment within an established infrastructure available across the United States. LAY SUMMARY: Reciprocal imitation training (RIT) is an evidence-based treatment for ASD that might be a good fit for use by intervention providers in widely accessible community-based settings. After attending an educational workshop on RIT, providers reported feeling more comfortable providing services to families with ASD concerns, used RIT with over 400 families, and believed that RIT improved important social communication behaviors.",2021,"From pre-training to post-training, there were significant increases in providers' self-efficacy in providing services to children with ASD or suspected ASD.","['87 EI providers enrolled from 9 agencies in 4 counties across Washington State, 66 were included in the current sample', 'providers serving toddlers from birth to 3\u2009years']","['reciprocal imitation training', 'Reciprocal imitation training (RIT', 'Reciprocal Imitation Training (RIT)-an NDBI-by community Early Intervention (EI; IDEA Part C']","[""providers' self-efficacy"", 'levels of RIT adoption, feasibility, and perceived RIT effectiveness', 'RIT adoption and rated items about RIT feasibility and perceived RIT effectiveness', 'important social communication behaviors', 'social-communication or motor imitation delays']","[{'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0459920', 'cui_str': 'Ability to think abstractly'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0172527,"From pre-training to post-training, there were significant increases in providers' self-efficacy in providing services to children with ASD or suspected ASD.","[{'ForeName': 'Lisa V', 'Initials': 'LV', 'LastName': 'Ibañez', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Stone', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington, USA.'}]",Autism research : official journal of the International Society for Autism Research,['10.1002/aur.2522']
838,34090959,Efficacy and safety of the oral Janus kinase inhibitor baricitinib in the treatment of adults with alopecia areata: Phase 2 results from a randomized controlled study.,"BACKGROUND


There are no treatments approved by the Food and Drug Administration for alopecia areata.
OBJECTIVE


To evaluate the efficacy and safety of baricitinib in patients with ≥50% scalp hair loss in a phase 2 study of adults with alopecia areata (BRAVE-AA1).
METHODS


Patients were randomized 1:1:1:1 to receive placebo or baricitinib 1 mg, 2 mg, or 4 mg once daily. Two consecutive interim analyses were performed after all patients completed weeks 12 and 36 or had discontinued treatment prior to these time points. The primary endpoint was the proportion of patients achieving a Severity of Alopecia Tool (SALT) score ≤20 at week 36. Logistic regression was used with nonresponder imputation for missing data.
RESULTS


A total of 110 patients were randomized (placebo, 28; baricitinib 1-mg, 28; 2-mg, 27; 4-mg, 27). The baricitinib 1-mg dose was dropped after the first interim analysis based on lower SALT 30  response rate. At week 36, the proportion of patients achieving a SALT score of ≤20 was significantly greater in baricitinib 2-mg (33.3%, P = .016) and 4-mg (51.9%, P = .001) groups versus placebo (3.6%). Baricitinib was well tolerated with no new safety findings.
LIMITATIONS


Small sample size limits generalizability of results.
CONCLUSION


These results support the efficacy and safety of baricitinib in patients with ≥50% scalp hair loss.",2021,"At Week 36, the proportion of patients achieving SALT score ≤20 was significantly greater in baricitinib 2-mg (33.3%, p=0.016) and 4-mg (51.9%, p=0.001) groups versus placebo (3.6%).","['Patients', 'adults with alopecia areata', 'patients with ≥50% scalp hair loss in a Phase 2 study of adults with AA (BRAVE-AA1; NCT03570749', 'alopecia areata (AA', 'A total of 110 patients were randomized ', 'patients with ≥50% scalp hair loss']","['placebo', 'placebo, baricitinib 1-mg, 2-mg, or 4-mg once daily', 'oral Janus kinase inhibitor baricitinib']","['proportion of patients achieving SALT score', 'Efficacy and safety', 'efficacy and safety of baricitinib', 'proportion of patients achieving Severity of Alopecia Tool (SALT) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0574769', 'cui_str': 'Loss of scalp hair'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3854325', 'cui_str': 'Janus kinase inhibitor'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}]",110.0,0.158251,"At Week 36, the proportion of patients achieving SALT score ≤20 was significantly greater in baricitinib 2-mg (33.3%, p=0.016) and 4-mg (51.9%, p=0.001) groups versus placebo (3.6%).","[{'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'King', 'Affiliation': 'Department of Dermatology, Yale School of Medicine, New Haven, Connecticut. Electronic address: brett.king@yale.edu.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ko', 'Affiliation': 'Department of Dermatology, Stanford University, Stanford, California.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Forman', 'Affiliation': 'ForCare Clinical Research, Tampa, Florida.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Ohyama', 'Affiliation': 'Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Mesinkovska', 'Affiliation': 'Department of Dermatology and Dermatopathology, University of California, Irvine, California.'}, {'ForeName': 'Guanglei', 'Initials': 'G', 'LastName': 'Yu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'McCollam', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Gamalo', 'Affiliation': 'Global Biometrics and Data Management, Pfizer Inc., Collegeville, Pennsylvania.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Janes', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Edson-Heredia', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Holzwarth', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dutronc', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2021.05.050']
839,34105767,Five-year maintenance of clinical response and health-related quality of life improvements in patients with moderate-to-severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2.,"BACKGROUND


Psoriasis is a chronic disease requiring long-term therapy.
OBJECTIVES


Physician- and patient-reported outcomes were evaluated through week 252 in VOYAGE 1 and VOYAGE 2.
METHODS


In total, 1829 patients were randomized at baseline to receive guselkumab 100 mg every 8 weeks, placebo or adalimumab. Patients receiving placebo crossed over to guselkumab at week 16. Patients receiving adalimumab crossed over to guselkumab at week 52 in VOYAGE 1, and randomized withdrawal and retreatment occurred at weeks 28-76 in VOYAGE 2; all patients then received open-label guselkumab through week 252. Efficacy and health-related quality of life (HRQoL) endpoints were analysed through week 252. Safety was monitored through week 264.
RESULTS


The proportions of patients in the guselkumab group who achieved clinical responses at week 252 in VOYAGE 1 and VOYAGE 2, respectively, were 84·1% and 82·0% [≥ 90% improvement in Psoriasis Area and Severity Index (PASI)]; 82·4% and 85·0% [Investigator's Global Assessment (IGA) 0 or 1]; 52·7% and 53·0% (100% improvement in PASI) and 54·7% and 55·5% (IGA 0). HRQoL endpoints were achieved as follows: 72·7% and 71·1% of patients (Dermatology Life Quality Index 0 or 1: no effect on patient's life); 42·4% and 42·0% [Psoriasis Symptoms and Signs Diary (PSSD) symptom score = 0] and 33·0% and 31·0% (PSSD sign score = 0). As measured in VOYAGE 2 only, approximately 45% of patients achieved ≥ 5-point reduction in Short Form-36 physical and mental component scores, and 80% reported no anxiety or depression (Hospital Anxiety and Depression Scale scores < 8). Similar findings were reported for adalimumab crossovers. These effects were maintained from week 52 in VOYAGE 1 and week 100 in VOYAGE 2. No new safety signals were identified.
CONCLUSIONS


Guselkumab maintains high levels of clinical response and improvement in patient-reported outcomes through 5 years in patients with moderate-to-severe psoriasis.",2021,"In VOYAGE 2 only, approximately 45% of patients achieved ≥5-point reduction in SF-36 Physical/Mental component scores and 80% reported no anxiety/depression (Hospital Anxiety and Depression scores <8).","['patients with moderate-to-severe psoriasis', 'A total of 1829 patients', 'patients with moderate-to-severe psoriasis treated with']","['guselkumab 100 mg every-8-weeks, placebo, or adalimumab; placebo', 'guselkumab', 'Adalimumab']","['anxiety/depression (Hospital Anxiety and Depression scores', 'HRQoL endpoints', 'clinical responses', 'health-related quality of life', '≥5-point reduction in SF-36 Physical/Mental component scores', 'clinical response and PRO improvement', 'Efficacy and HRQoL endpoints', 'Safety', 'Dermatology Life Quality Index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0585337', 'cui_str': 'Bimonthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}]",1829.0,0.0601639,"In VOYAGE 2 only, approximately 45% of patients achieved ≥5-point reduction in SF-36 Physical/Mental component scores and 80% reported no anxiety/depression (Hospital Anxiety and Depression scores <8).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Strober', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Y K', 'Initials': 'YK', 'LastName': 'Shen', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Janssen Global Services, LLC, Horsham and Malvern, PA, USA.'}, {'ForeName': 'Y W', 'Initials': 'YW', 'LastName': 'Yang', 'Affiliation': 'Janssen Global Services, LLC, Horsham and Malvern, PA, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ""The University of Melbourne, St Vincent's Hospital Melbourne and Probity Medical Research, Skin Health Institute, Carlton, VIC, Australia.""}, {'ForeName': 'C E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester, UK.'}]",The British journal of dermatology,['10.1111/bjd.20568']
840,34435371,"Fluoride Pharmacokinetics in Urine and Plasma Following Multiple Doses of MK-8507, an Investigational, Oral, Once-Weekly Nonnucleoside Reverse Transcriptase Inhibitor.","MK-8507 is an investigational HIV-1 nonnucleoside reverse transcriptase inhibitor being developed for the treatment of HIV-1 infection. MK-8507 contains 2 trifluoromethyl groups that may result in fluoride release through metabolism, but the extent of MK-8507-related fluoride release in humans has yet to be determined. This double-blind, placebo-controlled, 2-period, parallel-group, multiple-dose trial in healthy participants without HIV-1 who were administered a fluoride-restricted diet and once-weekly doses of MK-8507 aimed to estimate the relationship between MK-8507 dose and fluoride exposure. A total of 15 adult male and 3 adult female (of non-childbearing potential) participants were randomized to receive MK-8507 200 mg (n = 6), MK-8507 800 mg (n = 6), or placebo (n = 6). Change from baseline in mean daily fluoride excretion averaged over 7 days following the administration of MK-8507 200 mg resulted in a net mean increase of 19.8 μmol (90% confidence interval, 12.2-27.4) relative to placebo and did not exceed 57 μmol, a threshold related to the mean difference between the daily reference dose set by the US Environmental Protection Agency and the average dietary fluoride intake in the United States. However, daily urinary fluoride excretion exceeded the threshold following administration of 800 mg MK-8507 (75.1 μmol [90% confidence interval, 67.5-82.7]). Assuming a linear relationship between MK-8507 dose and estimated mean daily fluoride released at steady-state, data interpolation suggests that the US Environmental Protection Agency reference dose for fluoride would not be exceeded in most patients when administering MK-8507 at doses currently under clinical investigation (≤400 mg once weekly).",2022,"However, daily urinary fluoride excretion exceeded the threshold following administration of 800 mg MK-8507 (75.1 μmol [90% CI: 67.5, 82.7]).","['Fifteen adult male and 3 adult female (of non-childbearing potential) participants', 'healthy participants without HIV-1 administered a']","['placebo', 'fluoride-restricted diet', 'MK-8507']","['mean daily fluoride excretion', 'daily urinary fluoride excretion']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",15.0,0.161492,"However, daily urinary fluoride excretion exceeded the threshold following administration of 800 mg MK-8507 (75.1 μmol [90% CI: 67.5, 82.7]).","[{'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Gillespie', 'Affiliation': 'Merck & Co, Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Jackson Rudd', 'Affiliation': 'Merck & Co, Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Saijuan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Merck & Co, Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schaeffer', 'Affiliation': 'Merck & Co, Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Tomek', 'Affiliation': 'Celerion, Lincoln, Nebraska, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Larson', 'Affiliation': 'Merck & Co, Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'S Aubrey', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co, Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Iwamoto', 'Affiliation': 'Merck & Co, Inc., Kenilworth, New Jersey, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1957']
841,34446552,Poverty-related bandwidth constraints reduce the value of consumption.,"Poverty confers many costs on individuals, primarily through direct material deprivation. We hypothesize that these costs may be understated: poverty may also reduce human welfare by decreasing the experiential value of what little the poor are able to consume via reduced bandwidth (cognitive resources)-exerting a de facto ""tax"" on the value of consumption. We test this hypothesis using a randomized controlled trial in which we experimentally simulate key aspects of poverty that impair bandwidth via methods commonly used in laboratory studies (e.g., memorizing sequences) and via introducing stressors commonly associated with life in poverty (e.g., thinking about financial security and experiencing thirst). Participants then engaged in consumption activities and were asked to rate their enjoyment of these activities. Consistent with our hypothesis, the randomly assigned treatments designed to reduce bandwidth significantly and meaningfully reduced ratings of the consumption activities, with the strongest effects on the consumption of food. Our results shed additional light on how the consequences of poverty on human welfare may compound and motivate future work on the full scope of returns to poverty alleviation efforts.",2021,"Consistent with our hypothesis, the randomly assigned treatments designed to reduce bandwidth significantly and meaningfully reduced ratings of the consumption activities, with the strongest effects on the consumption of food.",[],[],[],[],[],[],,0.149617,"Consistent with our hypothesis, the randomly assigned treatments designed to reduce bandwidth significantly and meaningfully reduced ratings of the consumption activities, with the strongest effects on the consumption of food.","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Schofield', 'Affiliation': 'Division of Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104.'}, {'ForeName': 'Atheendar S', 'Initials': 'AS', 'LastName': 'Venkataramani', 'Affiliation': 'Division of Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104; atheenv@pennmedicine.upenn.edu.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2102794118']
842,34446531,Tenecteplase Reperfusion therapy in Acute ischaemic Cerebrovascular Events-II (TRACE II): rationale and design.,"BACKGROUND AND PURPOSE


Tenecteplase (TNK) is a promising agent for treatment of acute ischaemic stroke (AIS). We hypothesised that recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) is non-inferior to rt-PA in achieving excellent functional outcome at 90 days, when administered within 4.5 hours of ischaemic stroke onset.
METHODS AND DESIGN


Tenecteplase Reperfusion therapy in Acute ischemic Cerebrovascular Events (TRACE) is a phase III, multicentre, prospective, randomised, open-label, blinded-end point non-inferiority study. Patients eligible for intravenous thrombolysis therapy are randomised to rhTNK-tPA 0.25 mg/kg (single bolus) to a maximum of 25 mg or rt-PA 0.9 mg/kg (10% bolus+90% infusion/1 hour) to a maximum of 90 mg. Medications considered necessary for the patient's health may be given at the discretion of the investigator during 90-day follow-up.
STUDY OUTCOMES


The primary study outcome is excellent functional outcome defined as modified Rankin Scale (mRS) 0-1 at 90 days. Secondary efficacy outcomes include favourable functional outcome defined as mRS ≤2 at 90 days, ordinal distribution of mRS and major neurological improvement on the National Institutes of Health Stroke Scale. Safety outcomes are symptomatic intracranial haemorrhage within 36 hours and death from any cause.
DISCUSSION


There is no completed registration study of TNK in AIS worldwide. TRACE II strives to provide evidence for a new drug application for rhTNK-tPA in AIS within 4.5 hours through a well-designed and rigorously executed randomised trial in China.
TRIAL REGISTRATION NUMBER


NCT04797013.",2022,"Secondary efficacy outcomes include favourable functional outcome defined as mRS ≤2 at 90 days, ordinal distribution of mRS and major neurological improvement on the National Institutes of Health Stroke Scale.","['Acute ischemic Cerebrovascular Events (TRACE', 'Patients eligible for intravenous thrombolysis therapy']","['recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA', 'Tenecteplase Reperfusion therapy']","['favourable functional outcome defined as mRS ≤2 at 90 days, ordinal distribution of mRS and major neurological improvement on the National Institutes of Health Stroke Scale', 'excellent functional outcome defined as modified Rankin Scale (mRS) 0-1 at 90 days', 'symptomatic intracranial haemorrhage within 36 hours and death from any cause']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0842376,"Secondary efficacy outcomes include favourable functional outcome defined as mRS ≤2 at 90 days, ordinal distribution of mRS and major neurological improvement on the National Institutes of Health Stroke Scale.","[{'ForeName': 'Shuya', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Bruce C V', 'Initials': 'BCV', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine and Neurology, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lee H', 'Initials': 'LH', 'LastName': 'Schwamm', 'Affiliation': 'Department of Neurology and Comprehensive Stroke Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Parsons', 'Affiliation': 'Department of Neurology, Liverpool Hospital, South Western Sydney Clinical School, Sydney, New South Wales, Australia.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China yongjunwang@ncrcnd.org.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke and vascular neurology,['10.1136/svn-2021-001074']
843,34449285,Randomized Clinical Trial of Air Cleaners to Improve Indoor Air Quality and Chronic Obstructive Pulmonary Disease Health: Results of the CLEAN AIR Study.,"Rationale:  Indoor particulate matter is associated with worse chronic obstructive pulmonary disease (COPD) outcomes. It remains unknown whether reductions of indoor pollutants improve respiratory morbidity.  Objectives:  To determine whether placement of active portable high-efficiency particulate air cleaners can improve respiratory morbidity in former smokers.  Methods:  Eligible former smokers with moderate-to-severe COPD received active or sham portable high-efficiency particulate absolute air cleaners and were followed for 6 months in this blinded randomized controlled trial. The primary outcome was 6-month change in St. George's Respiratory Questionnaire (SGRQ). Secondary outcomes were exacerbation risk, respiratory symptoms, rescue medication use, and 6-minute-walk distance (6MWD). Intention-to-treat analysis included all subjects, and per-protocol analysis included adherent participants (greater than 80% use of air cleaner).  Measurements and Main Results:  A total of 116 participants were randomized, of which 84.5% completed the study. There was no statistically significant difference in total SGRQ score, but the active filter group had greater reduction in SGRQ symptom subscale (β, -7.7 [95% confidence interval (CI), -15.0 to -0.37]) and respiratory symptoms (Breathlessness, Cough, and Sputum Scale, β, -0.8 [95% CI, -1.5 to -0.1]); and lower rate of moderate exacerbations (incidence rate ratio, 0.32 [95% CI, 0.12-0.91]) and rescue medication use (incidence rate ratio, 0.54 [95% CI, 0.33-0.86]) compared with sham group (all  P  < 0.05). In per-protocol analysis, there was a statistically significant difference in primary outcome between the active filter versus sham group (SGRQ, β -4.76 [95% CI, -9.2 to -0.34]) and in moderate exacerbation risk, Breathlessness, Cough, and Sputum Scale, and 6MWD. Participants spending more time indoors were more likely to have treatment benefit.  Conclusions:  This is the first environmental intervention study conducted among former smokers with COPD showing potential health benefits of portable high-efficiency particulate absolute air cleaners, particularly among those with greater adherence and spending a greater time indoors.",2022,"There was no statistically significant difference in total SGRQ score, but the active filter group had greater reduction in SGRQ symptom subscale (ß -7.7 [95% CI, -15.0 to -0.37]) and respiratory symptoms (BCSS, ß -0.8 [95% CI, -1.5 to -0.1); and lower rate of moderate exacerbations (IRR 0.32","['116 participants were randomized of which 84.5% completed study', 'former smokers with COPD', 'Eligible former smokers with moderate-severe COPD received']",['active or sham portable HEPA air cleaners'],"['respiratory symptoms', 'rescue medication use', 'moderate exacerbation risk, BCSS and 6MWD', 'rate of moderate exacerbations', 'total SGRQ score', 'SGRQ symptom subscale', 'exacerbation risk, respiratory symptoms, rescue medication use and 6MWD', 'Indoor Air Quality and COPD Health', ""six-month change in Saint George's Respiratory Questionnaire (SGRQ""]","[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0789995', 'cui_str': 'Air cleaner'}]","[{'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085760', 'cui_str': 'Indoor Air Quality'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",116.0,0.764403,"There was no statistically significant difference in total SGRQ score, but the active filter group had greater reduction in SGRQ symptom subscale (ß -7.7 [95% CI, -15.0 to -0.37]) and respiratory symptoms (BCSS, ß -0.8 [95% CI, -1.5 to -0.1); and lower rate of moderate exacerbations (IRR 0.32","[{'ForeName': 'Nadia N', 'Initials': 'NN', 'LastName': 'Hansel', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Nirupama', 'Initials': 'N', 'LastName': 'Putcha', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Woo', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Peng', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; and.'}, {'ForeName': 'Gregory B', 'Initials': 'GB', 'LastName': 'Diette', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Fawzy', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Romero', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Meghan F', 'Initials': 'MF', 'LastName': 'Davis', 'Affiliation': 'Department of Environmental Health and Engineering and.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Rule', 'Affiliation': 'Department of Environmental Health and Engineering and.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Eakin', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Patrick N', 'Initials': 'PN', 'LastName': 'Breysse', 'Affiliation': 'Department of Environmental Health and Engineering and.'}, {'ForeName': 'Meredith C', 'Initials': 'MC', 'LastName': 'McCormack', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Department of Environmental Health and Engineering and.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202103-0604OC']
844,34089676,Flogging a Dead Salmon? Reduced Dose Posterior to Prostate Correlates With Increased PSA Progression in Voxel-Based Analysis of 3 Randomized Phase 3 Trials.,,2021,,[],[],['Reduced Dose Posterior to Prostate Correlates'],[],[],"[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}]",,0.130628,,"[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Shortall', 'Affiliation': 'Division of Cancer Science, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Palma', 'Affiliation': 'National Research Council, Institute of Biostructures and Bioimaging, Napoli, Italy.'}, {'ForeName': 'Hitesh', 'Initials': 'H', 'LastName': 'Mistry', 'Affiliation': 'Division of Cancer Science, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Vasquez Osorio', 'Affiliation': 'Division of Cancer Science, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'McWilliam', 'Affiliation': 'Division of Cancer Science, University of Manchester, Manchester, United Kingdom; Christie Medical Physics & Engineering, The Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Ananya', 'Initials': 'A', 'LastName': 'Choudhury', 'Affiliation': 'Division of Cancer Science, University of Manchester, Manchester, United Kingdom; Christie Medical Physics & Engineering, The Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Aznar', 'Affiliation': 'Division of Cancer Science, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'van Herk', 'Affiliation': 'Division of Cancer Science, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': 'Division of Cancer Science, University of Manchester, Manchester, United Kingdom. Electronic address: andrew.green-2@manchester.ac.uk.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.01.017']
845,34091726,Effects of face masks on performance and cardiorespiratory response in well-trained athletes.,"BACKGROUND


During the COVID-19 pandemic, compulsory masks became an integral part of outdoor sports such as jogging in crowded areas (e.g. city parks) as well as indoor sports in gyms and sports centers. This study, therefore, aimed to investigate the effects of medical face masks on performance and cardiorespiratory parameters in athletes.
METHODS


In a randomized, cross-over design, 16 well-trained athletes (age 27 ± 7 years, peak oxygen consumption 56.2 ± 5.6 ml kg -1  min -1 , maximum performance 5.1 ± 0.5 Watt kg -1 ) underwent three stepwise incremental exercise tests to exhaustion without mask (NM), with surgical mask (SM) and FFP2 mask (FFP2). Cardiorespiratory and metabolic responses were monitored by spiroergometry and blood lactate (BLa) testing throughout the tests.
RESULTS


There was a large effect of masks on performance with a significant reduction of maximum performance with SM (355 ± 41 Watt) and FFP2 (364 ± 43 Watt) compared to NM (377 ± 40 Watt), respectively (p < 0.001; ηp 2  = 0.50). A large interaction effect with a reduction of both oxygen consumption (p < 0.001; ηp 2  = 0.34) and minute ventilation (p < 0.001; ηp 2  = 0.39) was observed. At the termination of the test with SM 11 of 16 subjects reported acute dyspnea from the suction of the wet and deformed mask. No difference in performance was observed at the individual anaerobic threshold (p = 0.90).
CONCLUSION


Both SM and to a lesser extent FFP2 were associated with reduced maximum performance, minute ventilation, and oxygen consumption. For strenuous anaerobic exercise, an FFP2 mask may be preferred over an SM.",2022,A large interaction effect with a reduction of both oxygen consumption (p < 0.001; ηp 2  = 0.34) and minute ventilation (p < 0.001; ηp 2  = 0.39) was observed.,"['well-trained athletes', '16 well-trained athletes (age 27\u2009±\u20097\xa0years', 'athletes']","['peak oxygen consumption 56.2\u2009±\u20095.6\xa0ml', 'medical face masks', 'stepwise incremental exercise tests to exhaustion without mask (NM), with surgical mask (SM) and FFP2 mask (FFP2', 'strenuous anaerobic exercise', 'face masks']","['acute dyspnea', 'performance and cardiorespiratory response', 'performance', 'Cardiorespiratory and metabolic responses', 'oxygen consumption', 'maximum performance, minute ventilation, and oxygen consumption', 'spiroergometry and blood lactate (BLa) testing', 'minute ventilation']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0181758', 'cui_str': 'Surgical face mask'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0743323', 'cui_str': 'Acute dyspnea'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",,0.0813526,A large interaction effect with a reduction of both oxygen consumption (p < 0.001; ηp 2  = 0.34) and minute ventilation (p < 0.001; ηp 2  = 0.39) was observed.,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Egger', 'Affiliation': 'Department of Internal Medicine, Saarland University Hospital, Homburg, Saar, Germany. florian.egger@uni-saarland.de.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Blumenauer', 'Affiliation': 'Department of Internal Medicine, Saarland University Hospital, Homburg, Saar, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Fischer', 'Affiliation': 'Department of Internal Medicine, Saarland University Hospital, Homburg, Saar, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Venhorst', 'Affiliation': 'Institute of Sports and Preventive Medicine, Saarland University, Campus, Building B8 2, 66123, Saarbrücken, Germany.'}, {'ForeName': 'Saarraaken', 'Initials': 'S', 'LastName': 'Kulenthiran', 'Affiliation': 'Department of Internal Medicine, Saarland University Hospital, Homburg, Saar, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bewarder', 'Affiliation': 'Department of Internal Medicine, Saarland University Hospital, Homburg, Saar, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Zimmer', 'Affiliation': 'Department of Internal Medicine, Saarland University Hospital, Homburg, Saar, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Internal Medicine, Saarland University Hospital, Homburg, Saar, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Institute of Sports and Preventive Medicine, Saarland University, Campus, Building B8 2, 66123, Saarbrücken, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mahfoud', 'Affiliation': 'Department of Internal Medicine, Saarland University Hospital, Homburg, Saar, Germany.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-021-01877-0']
846,34110861,For whom does a match matter most? Patient-level moderators of evidence-based patient-therapist matching.,"OBJECTIVE


A double-blind, randomized controlled trial tested the effectiveness of a personalized Match System in which patients are assigned to therapists with a ""track record"" of effectively treating a given patient's primary concern(s) (e.g., anxiety). Matched patients demonstrated significantly better outcomes than those assigned through usual pragmatic means. The present study examined patient-level moderators of this match effect. We hypothesized that the match benefits would be especially pronounced for patients who presented with (a) greater overall problem severity, and (b) greater problem complexity (i.e., number of elevated problem domains). We also explored if patient racial/ethnic minority status moderated the condition effect.
METHOD


Patients were 218 adults randomized to the Match or as-usual assignment condition, and then treated naturalistically by 48 therapists. The primary outcome was the  Treatment Outcome Package  (TOP), a multidimensional assessment tool that also primed the Match algorithm (based on historical, therapist-level effectiveness data), and assessed trial patients' symptoms/functioning and demographic information at baseline. Moderator effects were tested as patient-level interactions in three-level hierarchical linear models.
RESULTS


The beneficial match effect was significantly more pronounced for patients with higher initial severity (-0.03, 95% CI -0.05, -0.01) and problem complexity (-0.01, 95% CI -0.02, -0.004), yet the high correlation between severity and complexity called into question the uniqueness of the complexity moderator effect. Moreover, the match effect was more pronounced for racial/ethnic minority patients (i.e., nonwhite; -0.05, 95% CI -0.09, -0.01).
CONCLUSIONS


Measurement-based matching is especially effective for patients with certain characteristics, which further informs mental health treatment personalization. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,"The beneficial match effect was significantly more pronounced for patients with higher initial severity (-0.03, 95% CI -0.05, -0.01) and problem complexity (-0.01, 95% CI -0.02, -0.004), yet the high correlation between severity and complexity called into question the uniqueness of the complexity moderator effect.","['Patients were 218 adults randomized to the Match or as-usual assignment condition, and then treated naturalistically by 48 therapists']",['personalized Match System'],"['problem complexity', ""Treatment Outcome Package  (TOP), a multidimensional assessment tool that also primed the Match algorithm (based on historical, therapist-level effectiveness data), and assessed trial patients' symptoms/functioning and demographic information""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",218.0,0.104452,"The beneficial match effect was significantly more pronounced for patients with higher initial severity (-0.03, 95% CI -0.05, -0.01) and problem complexity (-0.01, 95% CI -0.02, -0.004), yet the high correlation between severity and complexity called into question the uniqueness of the complexity moderator effect.","[{'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Boswell', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Constantino', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Coyne', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Kraus', 'Affiliation': 'Outcome Referrals, Inc.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000644']
847,34435439,Required dose of sugammadex or neostigmine for reversal of vecuronium-induced shallow residual neuromuscular block at a train-of-four ratio of 0.3.,"Residual shallow neuromuscular block (NMB) is potentially harmful and contributes to critical respiratory events. Evidence for the optimal dose of sugammadex required to reverse vecuronium-induced shallow NMB is scarce. The aims of the present study were to find suitable doses of sugammadex and neostigmine to reverse a residual vecuronium-induced NMB from a time of flight (TOF) ratio of 0.3-0.9 and evaluate their safety and efficacy. In total, 121 patients aged 18-65 years were randomly assigned to 11 groups to receive placebo, sugammadex (doses of 0.125, 0.25, 0.5, 1.0, or 2.0 mg/kg), or neostigmine (doses of 10, 25, 40, 55, or 70 μg/kg). The reversal time of sugammadex and neostigmine to antagonize a vecuronium-induced shallow residual NMB (i.e., TOF ratio of 0.3) and related adverse reactions were recorded. Several statistical models were tested to find an appropriate statistical model to explore the suitable doses of sugammadex and neostigmine required to reverse a residual vecuronium-induced NMB. Based on a monoexponential model with the response variable on a logarithmic scale, sugammadex 0.56 mg/kg may be sufficient to reverse vecuronium-induced shallow residual NMB at a TOF ratio of 0.3 under anesthesia maintained with propofol. Neostigmine may not provide prompt and satisfactory antagonism as sugammadex, even in shallow NMB.",2022,"The reversal time of sugammadex and neostigmine to antagonize a vecuronium-induced shallow residual NMB (i.e., TOF ratio of 0.3) and related adverse reactions were recorded.",['121 patients aged 18-65 years'],"['Sugammadex or Neostigmine', 'sugammadex and neostigmine', 'propofol', 'Residual shallow neuromuscular block (NMB', 'placebo, sugammadex', 'neostigmine', 'Neostigmine']","['safety and efficacy', 'reversal time of sugammadex and neostigmine', 'shallow residual NMB (i.e., TOF ratio of 0.3) and related adverse reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C4042763', 'cui_str': 'Postoperative Residual Curarisation'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",121.0,0.06041,"The reversal time of sugammadex and neostigmine to antagonize a vecuronium-induced shallow residual NMB (i.e., TOF ratio of 0.3) and related adverse reactions were recorded.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, General Hospital of Southern Theatre Command of PLA, Guangzhou, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, General Hospital of Southern Theatre Command of PLA, Guangzhou, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, General Hospital of Southern Theatre Command of PLA, Guangzhou, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, General Hospital of Southern Theatre Command of PLA, Guangzhou, China.'}, {'ForeName': 'Zhihao', 'Initials': 'Z', 'LastName': 'Lai', 'Affiliation': 'Department of Anesthesiology, General Hospital of Southern Theatre Command of PLA, Guangzhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, General Hospital of Southern Theatre Command of PLA, Guangzhou, China.'}]",Clinical and translational science,['10.1111/cts.13143']
848,34444833,Effects of a Behavioral Weight Loss Intervention and Metformin Treatment on Serum Urate: Results from a Randomized Clinical Trial.,"Background:  Lower body mass index (BMI) has been associated with lower serum urate (SU), but only in observational studies. We sought to determine the effects of behavioral weight loss and metformin treatment on SU in a randomized trial.  Methods and Findings:  The Survivorship Promotion In Reducing IGF-1 Trial (SPIRIT) was a parallel three-arm randomized controlled trial of overweight/obese adult cancer survivors without gout at a single center in Maryland, United States. Participants were randomized to: (1) coach-directed weight loss (behavioral telephonic coaching), (2) metformin (up to 2000 mg daily), or (3) self-directed weight loss (informational brochures; reference group). SU and BMI were assessed at baseline and at 3, 6, and 12 months post-randomization. The 121 participants had a mean ± standard deviation (SD) age of 60 ± 9 years, 79% were female, and 45% were Black. At baseline, BMI was 35 ± 5 kg/m 2 , and SU was 5.6 ± 1.3 mg/dL. Compared to the self-directed group, at 12 months, the coach-directed group reduced BMI by 0.9 kg/m 2  (95% confidence interval (CI): -1.5, -0.4) and metformin reduced BMI by 0.6 kg/m 2  (95% CI: -1.1, -0.1). However, compared to the self-directed group, the coach-directed group unexpectedly increased SU by 0.3 mg/dL (95% CI: 0.05, 0.6), and metformin non-significantly increased SU by 0.2 mg/dL (95% CI: -0.04, 0.5); these effects were attenuated when analyses included change in estimated glomerular filtration rate (eGFR).  Conclusions:  In this randomized trial of cancer survivors without gout, reductions in BMI either increased or did not change SU, potentially due to effects on eGFR. These results do not support a focus on BMI reduction for SU reduction; however, long-term studies are needed.  ClinicalTrials.gov Registration : NCT02431676.",2021,"However, compared to the self-directed group, the coach-directed group unexpectedly increased SU by 0.3 mg/dL (95% CI: 0.05, 0.6), and metformin non-significantly increased SU by 0.2 mg/dL (95% CI: -0.04, 0.5); these effects were attenuated when analyses included change in estimated glomerular filtration rate (eGFR).  ","['121 participants had a mean ± standard deviation (SD) age of 60 ± 9 years, 79% were female, and 45% were Black', 'overweight/obese adult cancer survivors without gout at a single center in Maryland, United States']","['Behavioral Weight Loss Intervention and Metformin Treatment', 'metformin', 'coach-directed weight loss (behavioral telephonic coaching), (2) metformin', 'Survivorship Promotion']","['body mass index', 'SU', 'metformin reduced BMI', 'glomerular filtration rate (eGFR', 'Serum Urate', 'BMI', 'SU and BMI']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}]",,0.442642,"However, compared to the self-directed group, the coach-directed group unexpectedly increased SU by 0.3 mg/dL (95% CI: 0.05, 0.6), and metformin non-significantly increased SU by 0.2 mg/dL (95% CI: -0.04, 0.5); these effects were attenuated when analyses included change in estimated glomerular filtration rate (eGFR).  ","[{'ForeName': 'Jiun-Ruey', 'Initials': 'JR', 'LastName': 'Hu', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN 37232, USA.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Welch Center for Epidemiology, Prevention, and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, MD 21287, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Mueller', 'Affiliation': 'Welch Center for Epidemiology, Prevention, and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, MD 21287, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Welch Center for Epidemiology, Prevention, and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, MD 21287, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Welch Center for Epidemiology, Prevention, and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, MD 21287, USA.'}, {'ForeName': 'Nisa M', 'Initials': 'NM', 'LastName': 'Maruthur', 'Affiliation': 'Welch Center for Epidemiology, Prevention, and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, MD 21287, USA.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Jerome', 'Affiliation': 'Department of Kinesiology, Towson University, Towson, MD 21252, USA.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Chang', 'Affiliation': 'Division of Nephrology, Geisinger Health, Danville, PA 17822, USA.'}, {'ForeName': 'Allan C', 'Initials': 'AC', 'LastName': 'Gelber', 'Affiliation': 'Welch Center for Epidemiology, Prevention, and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, MD 21287, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, CO-1309, #216, Boston, MA 02215, USA.'}]",Nutrients,['10.3390/nu13082673']
849,34449939,Ketamine administration for acute painful sickle cell crisis: A randomized controlled trial.,"OBJECTIVE


The objective was to evaluate the efficacy and safety of single-dose ketamine infusion in adults with sickle cell disease (SCD) who presented with acute sickle vasoocclusive crisis (VOC).
METHODS


This study was a parallel-group, prospective, randomized, double-blind, pragmatic trial. Participants were randomized to receive a single dose of either ketamine or morphine, infused over 30 min. Primary outcome was mean difference in the numerical pain rating scale (NPRS) score over 2 h. NPRS was recorded every 30 min for a maximum of 180 min and secondary outcomes were cumulative dose of opioids, emergency department (ED) length of stay, hospital admission, change in vital signs, and drug-related side effects. Authors performed the analysis using intention-to-treat principle.
RESULT


A total of 278 adults with SCD and who presented with acute sickle VOC participated in this trial. A total of 138 were allocated to the ketamine group. Mean (±standard deviation [SD]) NPRS scores over 2 h were 5.7 (±2.13) and 5.6 (±1.90) in the ketamine and morphine groups. The ketamine group received significantly lower cumulative doses of morphine during their ED stay (mean ± SD = 4.5 ± 4.6 mg) than of the morphine group (mean ± SD = 8.5 ± 7.55 mg). Both groups had similar rates of hospital admission: 6.3% in the ketamine group had drug-related side effects compared to 2.2% in the morphine group.
CONCLUSION


Early use of ketamine in adults with VOC resulted in a meaningful reduction in pain scores over a 2-h period and reduced the cumulative morphine dose in the ED with no significant drug-related side effects in the ketamine-treated group.",2022,Early use of ketamine in adults with VOC resulted in a meaningful reduction in pain scores over a 2-h period and reduced the cumulative morphine dose in the ED with no significant drug-related side effects in the ketamine treated group.,"['278 adults with sickle cell disease and presented with acute sickle vaso-occlusive crisis', 'adults with VOC', 'adults with sickle cell disease who presented with acute sickle vaso-occlusive crisis', 'Acute Painful Sickle Cell Crisis']","['Ketamine', 'single-dose ketamine infusion', 'ketamine', 'ketamine or morphine', 'morphine']","['numerical pain rating score (NPRS', 'efficacy and safety', 'rates of hospital admission', 'cumulative dose of opioids, ED length of stay, hospital admission, change in vital signs, and drug-related side effects', 'cumulative doses of morphine during ED stay', 'NPRS', 'Mean numerical pain rating score', 'pain scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0238425', 'cui_str': 'Hemoglobin SS disease with crisis'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",278.0,0.625577,Early use of ketamine in adults with VOC resulted in a meaningful reduction in pain scores over a 2-h period and reduced the cumulative morphine dose in the ED with no significant drug-related side effects in the ketamine treated group.,"[{'ForeName': 'Mohammed S', 'Initials': 'MS', 'LastName': 'Alshahrani', 'Affiliation': 'Emergency and Critical Care Departments, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Amal H', 'Initials': 'AH', 'LastName': 'AlSulaibikh', 'Affiliation': 'Emergency Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Mohamed R', 'Initials': 'MR', 'LastName': 'ElTahan', 'Affiliation': 'Anesthesiology Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Sukayna Z', 'Initials': 'SZ', 'LastName': 'AlFaraj', 'Affiliation': 'Emergency Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Laila P', 'Initials': 'LP', 'LastName': 'Asonto', 'Affiliation': 'Emergency and Critical Care Departments, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Abdullah A', 'Initials': 'AA', 'LastName': 'AlMulhim', 'Affiliation': 'Emergency Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Murad F', 'Initials': 'MF', 'LastName': 'AlAbbad', 'Affiliation': 'Emergency Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Nisreen', 'Initials': 'N', 'LastName': 'Almaghraby', 'Affiliation': 'Emergency Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'AlJumaan', 'Affiliation': 'Emergency Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Thamir O', 'Initials': 'TO', 'LastName': 'AlJunaid', 'Affiliation': 'Emergency Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Moath N', 'Initials': 'MN', 'LastName': 'Darweesh', 'Affiliation': 'Emergency Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Faisal M', 'Initials': 'FM', 'LastName': 'AlHawaj', 'Affiliation': 'Emergency Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Alaa M', 'Initials': 'AM', 'LastName': 'Mahmoud', 'Affiliation': 'Emergency Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Bader K', 'Initials': 'BK', 'LastName': 'Alossaimi', 'Affiliation': 'Emergency Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Shaikhah K', 'Initials': 'SK', 'LastName': 'Alotaibi', 'Affiliation': 'Emergency Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Talal M', 'Initials': 'TM', 'LastName': 'AlMutairi', 'Affiliation': 'Emergency Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Duaa A', 'Initials': 'DA', 'LastName': 'AlSulaiman PharmD', 'Affiliation': 'Pharmacy Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Dunya', 'Initials': 'D', 'LastName': 'Alfaraj', 'Affiliation': 'Emergency Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Alhawwas', 'Affiliation': 'Emergency Department, King Fahad Hospital of the University-Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Mbuagbaw', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Verhovsek', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Crowther', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Guyatt', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Alhazzani', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14382']
850,34455200,The effects of perioperative dexamethasone on eicosanoids and mediators of inflammation resolution: A sub-study of the PADDAG trial.,"INTRODUCTION


Dexamethasone is an antiemetic that is frequently administered before or after the induction of anesthesia for prevention and treatment of perioperative nausea and vomiting. Dexamethasone has anti-inflammatory and immunosuppressive effects primarily via suppression of expression of inflammatory mediators. However, its effect on the eicosanoids and docosanoids that mediate the inflammatory response and inflammation resolution are unclear. We aimed to assess the effect of a single dose of intra-operative dexamethasone on peri‑operative eicosanoids involved in inflammation including leukotriene B 4  (LTB 4 ) and 20-hydroxyeicosatetraenoic acid (20-HETE), and inflammation resolution (Specialised Proresolving Mediators (SPM)).
PATIENTS AND METHODS


A subgroup of 80 patients from the randomised controlled PADDAG trial was enrolled into this substudy. They were allocated to receive 0, 4 or 8 mg dexamethasone administered intravenously at induction of anesthesia. Blood samples were collected before and 24 h after dexamethasone, for measurement of leukocytes, hs-CRP, LTB 4,  20-HETE, the SPM pathway intermediates (14-HDHA, 18-HEPE and 17-HDHA) and SPMs (E-series resolvins, and d-series resolvins).
RESULTS


Compared to the administration of placebo, neutrophil count was elevated (P<0.05) 24 h after administration of 4 and 8 mg dexamethasone. Dexamethasone (8 mg) resulted in increased levels of LTB 4  (P = 0.012) and 20-HETE (P = 0.009) and reduced hs-CRP levels (P<0.001). Dexamethasone did not significantly affect plasma SPM pathway intermediates or RvE3.
CONCLUSION


Antiemetic doses of dexamethasone given during surgery increased plasma LTB 4  and 20-HETE at a time when hs-CRP was significantly reduced. Plasma SPM pathway intermediates and RvE3 were unaffected.",2021,Dexamethasone (8 mg) resulted in increased levels of LTB 4  (P = 0.012) and 20-HETE,['A subgroup of 80 patients'],"['perioperative dexamethasone', 'Dexamethasone', '20-HETE', 'dexamethasone', 'placebo', 'intra-operative dexamethasone']","['Blood samples', 'neutrophil count', 'plasma LTB 4  and 20-HETE', 'reduced hs-CRP levels', 'plasma SPM pathway intermediates or RvE3', 'eicosanoids and mediators of inflammation resolution', 'Plasma SPM pathway intermediates and RvE3', 'levels of LTB 4', 'measurement of leukocytes, hs-CRP, LTB 4,  20-HETE, the SPM pathway intermediates (14-HDHA, 18-HEPE and 17-HDHA) and SPMs (E-series resolvins, and d-series resolvins', 'inflammation including leukotriene B 4  (LTB 4 ) and 20-hydroxyeicosatetraenoic acid (20-HETE), and inflammation resolution (Specialised Proresolving Mediators (SPM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0046616', 'cui_str': '20-hydroxy-5,8,11,14-eicosatetraenoic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1664181', 'cui_str': 'LTB protein, human'}, {'cui': 'C0046616', 'cui_str': '20-hydroxy-5,8,11,14-eicosatetraenoic acid'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038111', 'cui_str': 'Saint Pierre and Miquelon'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0013725', 'cui_str': 'Eicosanoid'}, {'cui': 'C0243042', 'cui_str': 'Mediator of inflammation'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0019215', 'cui_str': ""N-2-Hydroxyethylpiperazine-N'-2'-ethanesulfonic Acid""}, {'cui': 'C4310301', 'cui_str': '17(S)-HDHA'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023546', 'cui_str': 'LTB4'}, {'cui': 'C0205555', 'cui_str': 'Special'}]",80.0,0.200124,Dexamethasone (8 mg) resulted in increased levels of LTB 4  (P = 0.012) and 20-HETE,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Barden', 'Affiliation': 'Medical School, Royal Perth Hospital Unit University of Western Australia, Australia. Electronic address: anne.barden@uwa.edu.au.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Phillips', 'Affiliation': 'Harry Perkins Institute of Medical Research, University of Western Australia, Australia.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Shinde', 'Affiliation': 'Medical School, Royal Perth Hospital Unit University of Western Australia, Australia.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Corcoran', 'Affiliation': 'Department of Anaesthesia & Pain Medicine, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Mori', 'Affiliation': 'Medical School, Royal Perth Hospital Unit University of Western Australia, Australia.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2021.102334']
851,34455171,"Grip training improves handgrip strength, cognition, and brain white matter in minor acute ischemic stroke patients.","OBJECTIVE


A large proportion of stroke patients experience cognitive impairment. Previous studies found that handgrip training can improve cognitive dysfunction after stroke through an unknown mechanism. In this study, we aimed to examine the influence of handgrip training on the cognition of patients with acute mild ischemic stroke and explore the mechanism using an advanced post-processing method for magnetic resonance imaging.
METHODS


Seventy-six patients with acute mild ischemic stroke were recruited for this study and randomly divided into a grip training group (n = 37) and a control group (n = 39). Both groups of patients also received standardized treatment for stroke in the acute phase and for secondary prevention, as well as conventional physical therapy after stroke. Grip strength, global cognitive function, and the local and global efficiencies of white matter networks derived from diffusion tensor images were measured before and after the 12-week training period.
RESULTS


In the within-group comparisons, grip training significantly improved the grip strength (3.52 [3.09-3.96], p = 0.02), Montreal Cognitive Assessment (MoCA) (2.27 [1.68-2.86], p = 0.05), and local, but not global, efficiency of the brain white matter network (0.03 [0.02-0.03], p = 0.02) in the experimental group. In contrast, these parameters were not statistically different over the same period in the control group. In the between-groups comparisons, the improvement of grip strength (2.71 [2.20-3.21], p = 0.01), MoCA (1.17 [0.39-1.95], p = 0.05), and local efficiency (0.02 [0.01-0.03], p = 0.01) showed statistically significant differences after the intervention, but not the absolute value of them, neither at the base line nor after the intervention.
CONCLUSIONS


Our results indicate that grip training can improve cognitive function by increasing the local efficiency of brain white matter connectivity. This suggests that white matter remodeling is a potential physiological mechanism connecting grip training and cognition improvement.",2021,"In the within-group comparisons, grip training significantly improved the grip strength (3.52 [3.09-3.96], p = 0.02), Montreal Cognitive Assessment (MoCA) (2.27 [1.68-2.86], p = 0.05), and local, but not global, efficiency of the brain white matter network (0.03 [0.02-0.03], p = 0.02) in the experimental group.","['minor acute ischemic stroke patients', 'Seventy-six patients with acute mild ischemic stroke', 'patients with acute mild ischemic stroke', 'stroke patients experience cognitive impairment']","['grip training', 'grip training group', 'handgrip training', 'Grip training']","['Grip strength, global cognitive function, and the local and global efficiencies of white matter networks', 'cognitive dysfunction', 'MoCA', 'handgrip strength, cognition, and brain white matter', 'local efficiency', 'cognitive function', 'Montreal Cognitive Assessment (MoCA', 'grip strength']","[{'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",76.0,0.00546038,"In the within-group comparisons, grip training significantly improved the grip strength (3.52 [3.09-3.96], p = 0.02), Montreal Cognitive Assessment (MoCA) (2.27 [1.68-2.86], p = 0.05), and local, but not global, efficiency of the brain white matter network (0.03 [0.02-0.03], p = 0.02) in the experimental group.","[{'ForeName': 'Xinyuan', 'Initials': 'X', 'LastName': 'Shang', 'Affiliation': ""Department of Neurology, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Xianyue', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': ""Department of Neurology, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Xinxing', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Department of Neurology, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Zhentao', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': ""Department of Rehabilitation, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': ""Department of Neurology, Liaocheng People's Hospital, Liaocheng 252000, China. Electronic address: 554022790@qq.com.""}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2021.106886']
852,34990385,"Clinical presentation, microbiological aetiology and disease course in patients with flu-like illness: a post hoc analysis of randomised controlled trial data.","BACKGROUND


There is little evidence about the relationship between aetiology, illness severity, and clinical course of respiratory tract infections (RTIs) in primary care. Understanding these associations would aid in the development of effective management strategies for these infections.
AIM


To investigate whether clinical presentation and illness course differ between RTIs where a viral pathogen was detected and those where a potential bacterial pathogen was found.
DESIGN AND SETTING


Post hoc analysis of data from a pragmatic randomised trial on the effects of oseltamivir in patients with flu-like illness in primary care ( n  = 3266) in 15 European countries.
METHOD


Patient characteristics and their signs and symptoms of disease were registered at baseline. Nasopharyngeal (adults) or nasal and pharyngeal (children) swabs were taken for polymerase chain reaction analysis. Patients were followed up until 28 days after inclusion. Regression models and Kaplan-Meier curves were used to analyse the relationship between aetiology, clinical presentation at baseline, and course of disease including complications.
RESULTS


Except for a less prominent congested nose (odds ratio [OR] 0.55, 95% confidence interval [CI] = 0.35 to 0.86) and acute cough (OR 0.42, 95% CI = 0.27 to 0.65) in patients with flu-like illness in whom a possible bacterial pathogen was isolated, there were no clear clinical differences in presentations between those with a possible bacterial aetiology compared with those with a viral aetiology. Also, course of disease and complications were not related to aetiology.
CONCLUSION


Given current available microbiological tests and antimicrobial treatments, and outside pandemics such as COVID-19, microbiological testing in primary care patients with flu-like illness seems to have limited value. A wait-and-see policy in most of these patients with flu-like illness seems the best option.",2022,"Except for a less prominent congested nose (odds ratio [OR] 0.55, 95% confidence interval [CI] = 0.35 to 0.86) and acute cough (OR 0.42, 95% CI = 0.27 to 0.65) in patients with flu-like illness in whom a possible bacterial pathogen was isolated, there were no clear clinical differences in presentations between those with a possible bacterial aetiology compared with those with a viral aetiology.","['patients with flu-like illness', 'Nasopharyngeal (adults) or nasal and pharyngeal (children', 'patients with flu-like illness in primary care ( n  = 3266) in 15 European countries', 'primary care patients with flu-like illness']",['oseltamivir'],['acute cough'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521839', 'cui_str': 'Influenza-like illness'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0454713', 'cui_str': 'European country'}]","[{'cui': 'C0874161', 'cui_str': 'Oseltamivir'}]","[{'cui': 'C0742857', 'cui_str': 'Acute cough'}]",,0.3471,"Except for a less prominent congested nose (odds ratio [OR] 0.55, 95% confidence interval [CI] = 0.35 to 0.86) and acute cough (OR 0.42, 95% CI = 0.27 to 0.65) in patients with flu-like illness in whom a possible bacterial pathogen was isolated, there were no clear clinical differences in presentations between those with a possible bacterial aetiology compared with those with a viral aetiology.","[{'ForeName': 'Theo J', 'Initials': 'TJ', 'LastName': 'Verheij', 'Affiliation': 'Julius Center for Health Science and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Cianci', 'Affiliation': 'Julius Center for Health Science and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Alike W', 'Initials': 'AW', 'LastName': 'van der Velden', 'Affiliation': 'Julius Center for Health Science and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care, University of Oxford Medical Sciences Division, Oxford, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bongard', 'Affiliation': 'Nuffield Department of Primary Care, University of Oxford Medical Sciences Division, Oxford, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Coenen', 'Affiliation': 'Department of Primary and Interdisciplinary Care (ELIZA) - Centre for General Practice, University of Antwerp Faculty of Medicine and Health Sciences, Antwerp, Belgium.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Colliers', 'Affiliation': 'Department of Primary and Interdisciplinary Care (ELIZA) - Centre for General Practice, University of Antwerp Faculty of Medicine and Health Sciences, Antwerp, Belgium.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Francis', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Maciek', 'Initials': 'M', 'LastName': 'Godycki-Cwirko', 'Affiliation': 'Division of Public Health, Centre for Family and Community Medicine, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Llor', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark; University Institute in Primary Care Research Jordi Gol, Via Roma Health Centre, Barcelona, Spain.'}, {'ForeName': 'Sławomir', 'Initials': 'S', 'LastName': 'Chlabicz', 'Affiliation': 'Department of Family Medicine, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Lionis', 'Affiliation': 'Clinic of Social and Family Medicine, University of Crete School of Medicine, Heraklion, Greece.'}, {'ForeName': 'Pär-Daniel', 'Initials': 'PD', 'LastName': 'Sundvall', 'Affiliation': 'Research and Development Primary Health Care, Västra Götalandsregionen, University of Gothenburg; Sahlgrenska Academy, Department of Public Health and Community Medicine/Primary Health Care, Institute of Medicine, Gothenburg, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bjerrum', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'De Sutter', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University Faculty of Medicine and Health Sciences, Ghent, Belgium.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Aabenhus', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolay Jonassen', 'Initials': 'NJ', 'LastName': 'Harbin', 'Affiliation': 'Antibiotic Center for Primary Care, Department of General Practice, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Lindbæk', 'Affiliation': 'Antibiotic Center for Primary Care, Department of General Practice, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Glinz', 'Affiliation': 'Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Heiner C', 'Initials': 'HC', 'LastName': 'Bucher', 'Affiliation': 'Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Bernadett', 'Initials': 'B', 'LastName': 'Kovács', 'Affiliation': 'Drug Research Center, Balatonfüred, Hungary.'}, {'ForeName': 'Bohumil', 'Initials': 'B', 'LastName': 'Seifert', 'Affiliation': 'Department of General Practice, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Ruta Radzeviciene', 'Initials': 'RR', 'LastName': 'Jurgute', 'Affiliation': 'JSC Mano Seimos Gydytojas, Klaipeda, Lithuania.'}, {'ForeName': 'Pia Touboul', 'Initials': 'PT', 'LastName': 'Lundgren', 'Affiliation': ""Départment de Santé Publique, Université Côte d'Azur Faculté de Médecine, Nice, France.""}, {'ForeName': 'Muireann', 'Initials': 'M', 'LastName': 'de Paor', 'Affiliation': 'Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Matheeussen', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine & Infectious Diseases Institute, University Hospital Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Goossens', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine & Infectious Diseases Institute, University Hospital Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Ieven', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine & Infectious Diseases Institute, University Hospital Antwerp, Antwerp, Belgium.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/BJGP.2021.0344']
853,34446377,Feasibility of implementing an exercise intervention in older adults with hematologic malignancy.,"Older adults with Hematologic Malignancy (HM) are vulnerable to functional decline secondary to disease and treatment. Interventions for physical deconditioning, in concert with routine hematology care are limited. The feasibility of accrual, retention, and demand for an exercise intervention among a high-risk HM population was piloted.
METHODS


Older adults with HM, on active treatment, with functional impairment were recruited prospectively to participate in a 6-month Otago Exercise Programme (OEP). Measures of motivation, self-efficacy, patient identified barriers to exercise, barriers to clinical trial enrollment, study satisfaction, and serious adverse events were captured.
RESULTS


63 patients were approached, 18 declined trial enrollment, 45 consented, 30 patients enrolled in the exercise program. The main barrier for trial enrollment was transportation/travel concerns (n = 15). Of the 45 consented participants, 8 (12.7%) dropped out due to clinical deterioration, 5 (7.9%) withdrew, and 2 (3.2%) were ineligible prior to exercise-intervention intiation. The median age was 75.5 years (range 62-83) with plasma cell dyscrasia (63%), non-Hodgkin lymphoma (20%) and leukemia (17%). Retention of the physical therapist (PT) led-OEP was 76.6% of patients (n = 23/30), and end-of-study retention was 66.7% (n = 20/30). Of the evaluable patients, 23/29 completed the PE-led OEP yielding a completion rate of 79%. Participants were extremely motivated (72.4%) and strongly intended (89.7%) to engage in regular physical activity. Exercising when tired increased from a median score of 50 at Visit 1 to 70 at Visit 2, but dropped significantly to 45 at Visit 3 (p < 0.001). Participants reported significantly lower self-efficacy to exercise over the next 6 months from Visit 1 to Visit 3 (p = 0.001).
CONCLUSIONS


Older patients with HM had higher completion of in-person, PT-led exercise compared to at-home, independent exercise. Older adults were motivated and found the program acceptable, yet the ability to sustain a structured exercise program was challenging due to changes in health status. ClinicalTrials.gov Identifier: NCT02791737.",2022,"Retention of the physical therapist (PT) led-OEP was 76.6% of patients (n = 23/30), and end-of-study retention was 66.7% (n = 20/30).","['Older patients with HM', 'older adults with hematologic malignancy', 'Older adults with HM, on active treatment, with functional impairment were recruited prospectively to participate in a 6-month', '45 consented participants, 8 (12.7%) dropped out due to clinical deterioration, 5 (7.9%) withdrew, and 2 (3.2%) were ineligible prior to exercise-intervention intiation', 'Older adults with Hematologic Malignancy (HM', 'The median age was 75.5\xa0years (range 62-83) with plasma cell dyscrasia (63%), non-Hodgkin lymphoma (20%) and leukemia (17', 'Older adults', '63 patients were approached, 18 declined trial enrollment, 45 consented, 30 patients enrolled in the exercise program']","['exercise intervention', 'Otago Exercise Programme (OEP']","['motivation, self-efficacy, patient identified barriers to exercise, barriers to clinical trial enrollment, study satisfaction, and serious adverse events', 'self-efficacy to exercise']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4505323', 'cui_str': 'Clinical Deterioration'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1136084', 'cui_str': 'Plasma cell disorder'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",30.0,0.0586411,"Retention of the physical therapist (PT) led-OEP was 76.6% of patients (n = 23/30), and end-of-study retention was 66.7% (n = 20/30).","[{'ForeName': 'AshleyE', 'Initials': 'A', 'LastName': 'Rosko', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH, United States of America; Division of Hematology, The Ohio State University, Columbus, OH, United States of America. Electronic address: ashley.rosko@osumc.edu.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Division of Hematology, The Ohio State University, Columbus, OH, United States of America.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Division of Hematology, The Ohio State University, Columbus, OH, United States of America.'}, {'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Presley', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH, United States of America; Division of Medical Oncology, The Ohio State University, Columbus, OH, United States of America.'}, {'ForeName': 'Jordon', 'Initials': 'J', 'LastName': 'Jaggers', 'Affiliation': 'College of Medicine, The Ohio State University, Columbus, OH, United States of America.'}, {'ForeName': 'ReNea', 'Initials': 'R', 'LastName': 'Owens', 'Affiliation': 'Rehabilitation Services, The Ohio State University, Columbus, OH, United States of America.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Naughton', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH, United States of America; Cancer Prevention and Control, The Ohio State University, Columbus, OH, United States of America.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Krok-Schoen', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH, United States of America; Division of Medical Dietetics and Health Sciences, School of Health and Rehabilitation Sciences, College of Medicine, The Ohio State University, Columbus, OH, United States of America.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2021.07.010']
854,34453111,Is it time to study routine car seat tolerance screening in a randomized controlled trial? An international survey of current practice and clinician equipoise.,,2021,,[],[],[],[],[],[],,0.234582,,"[{'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Jensen', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia and The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA. jensene@chop.edu.""}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Greenspan', 'Affiliation': 'Division of Neonatology, Nemours/Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Zubair H', 'Initials': 'ZH', 'LastName': 'Aghai', 'Affiliation': 'Division of Neonatology, Nemours/Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Carola', 'Affiliation': 'Division of Neonatology, Nemours/Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Eichenwald', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia and The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.""}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'DeMauro', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia and The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Dysart', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia and The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-021-01167-7']
855,34459060,Sleep extension and metabolic health in male overweight/obese short sleepers: A randomised controlled trial.,"While limited evidence suggests that longer sleep durations can improve metabolic health in habitual short sleepers, there is no consensus on how sustained sleep extension can be achieved. A total of 18 men (mean [SD] age 41 [ 9] years), who were overweight/obese (mean [SD] body mass index 30 [3] kg/m 2  ) and short sleepers at increased risk of type 2 diabetes were randomised to a 6-week sleep-extension programme based on cognitive behavioural principles (n = 10) or a control (n = 8) group. The primary outcome was 6-week change in actigraphic total sleep time (TST). Fasting plasma insulin, insulin resistance (Homeostatic Model Assessment for Insulin Resistance [HOMA-IR]), blood pressure, appetite-related hormones from a mixed-meal tolerance test, and continuous glucose levels were also measured. Baseline to 6-week change in TST was greater in the sleep-extension group, at 79 (95% confidence interval [CI] 68.90, 88.05) versus 6 (95% CI -4.43, 16.99) min. Change in the sleep-extension and control groups respectively also showed: lower fasting insulin (-11.03 [95% CI -22.70, 0.65] versus 7.07 [95% CI -4.60, 18.74] pmol/L); lower systolic (-11.09 [95% CI -17.49, -4.69] versus 0.76 [95% CI -5.64, 7.15] mmHg) and diastolic blood pressure (-12.16 [95% CI -17.74, -6.59] versus 1.38 [95% CI -4.19, 6.96] mmHg); lower mean amplitude of glucose excursions (0.34 [95% CI -0.57, -0.12] versus 0.05 [95% CI -0.20, 0.30] mmol/L); lower fasting peptide YY levels (-18.25 [95%CI -41.90, 5.41] versus 21.88 [95% CI -1.78, 45.53] pg/ml), and improved HOMA-IR (-0.51 [95% CI -0.98, -0.03] versus 0.28 [95% CI -0.20, 0.76]). Our protocol increased TST and improved markers of metabolic health in male overweight/obese short sleepers.",2022,"Fasting plasma insulin, insulin resistance (Homeostatic Model Assessment for Insulin Resistance","['18 men (mean [SD] age 41\xa0[\xa09]\xa0years), who were overweight/obese (mean [SD] body mass index 30', 'male overweight/obese short sleepers']",['6-week sleep-extension programme based on cognitive behavioural principles (n\xa0=\xa010) or a control'],"['metabolic health', 'systolic', 'diastolic blood pressure', 'Fasting plasma insulin, insulin resistance (Homeostatic Model Assessment for Insulin Resistance', 'lower fasting insulin', 'TST', 'Sleep extension and metabolic health', 'HOMA-IR', 'fasting peptide YY levels ', 'mean amplitude of glucose excursions', 'HOMA-IR]), blood pressure, appetite-related hormones from a mixed-meal tolerance test, and continuous glucose levels', 'actigraphic total sleep time (TST']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0751509', 'cui_str': 'Short-sleeper'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",18.0,0.44716,"Fasting plasma insulin, insulin resistance (Homeostatic Model Assessment for Insulin Resistance","[{'ForeName': 'Iuliana', 'Initials': 'I', 'LastName': 'Hartescu', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Dorling', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Eva N', 'Initials': 'EN', 'LastName': 'Rogers', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Hall', 'Affiliation': 'The Hanning Sleep Laboratory, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Emer M', 'Initials': 'EM', 'LastName': 'Brady', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'National Institute for Health Research (NIHR), Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'National Institute for Health Research (NIHR), Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Morgan', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}]",Journal of sleep research,['10.1111/jsr.13469']
856,34455507,"The relationship of plasma antioxidant levels to semen parameters: the Males, Antioxidants, and Infertility (MOXI) randomized clinical trial.","PURPOSE


The understanding of the role of plasma antioxidant levels in male fertility in the USA is limited. In a secondary analysis of the Males, Antioxidants, and Infertility (MOXI) randomized clinical trial, we sought to determine whether serum levels of vitamin E (α-tocopherol), zinc, and selenium were correlated with semen parameters and couple fertility outcomes.
METHODS


This study is a secondary analysis of the MOXI clinical trial. The primary endpoints in this secondary analysis include semen parameters, and DNA fragmentation and clinical outcomes including pregnancy and live birth. Analyses were completed using Wilcoxon's rank-sum test and linear regression models.
RESULTS


At baseline, the analysis included plasma labs for vitamin E (n = 131), selenium (n = 124), and zinc (n = 128). All baseline plasma values were in the normal ranges. There was no association between selenium, zinc, or vitamin E levels and semen parameters or DNA fragmentation. Baseline antioxidant levels in the male partners did not predict pregnancy or live birth among all couples. Among those randomized to placebo, baseline male antioxidant levels did not differ between those couples with live birth and those that did not conceive or have a live birth.
CONCLUSIONS


Among men attending fertility centers in the USA, who have sufficient plasma antioxidant levels of zinc, selenium, or vitamin E, no association was observed between vitamins and semen parameters or clinical outcomes in couples with male infertility. Higher levels of antioxidants among men with circulating antioxidants in the normal range do not appear to confer benefit on semen parameters or male fertility.",2021,Higher levels of antioxidants among men with circulating antioxidants in the normal range do not appear to confer benefit on semen parameters or male fertility.,"['men attending fertility centers', 'male partners', 'couples with male infertility']",['placebo'],"['Baseline antioxidant levels', 'semen parameters, and DNA fragmentation and clinical outcomes including pregnancy and live birth', 'baseline male antioxidant levels', 'selenium, zinc, or vitamin E levels and semen parameters or DNA fragmentation', 'serum levels of vitamin E (α-tocopherol), zinc, and selenium']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0021364', 'cui_str': 'Male infertility'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C1142098', 'cui_str': 'Vitamin E measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}]",,0.460461,Higher levels of antioxidants among men with circulating antioxidants in the normal range do not appear to confer benefit on semen parameters or male fertility.,"[{'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Knudtson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Health Science Center San Antonio, San Antonio, Texas; and Aspire Fertility, San Antonio, TX, USA. jenk1022@gmail.com.'}, {'ForeName': 'Fangbai', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'R Matthew', 'Initials': 'RM', 'LastName': 'Coward', 'Affiliation': 'Department of Urology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, Health Sciences Center, University of Oklahoma, Oklahoma City, OK, USA.'}, {'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Department of Urology, University of California- San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Krawetz', 'Affiliation': 'Department of Obstetrics and Gynecology & Molecular Medicine and Genetics, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Usadi', 'Affiliation': 'Department of Reproductive Endocrinology and Infertility, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Baker', 'Affiliation': 'Department of Gynecology and Obstetrics, Division of Reproductive Endocrinology and Infertility, Johns Hopkins University, Lutherville, MD, USA.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Anne Z', 'Initials': 'AZ', 'LastName': 'Steiner', 'Affiliation': 'Department of Reproductive Endocrinology and Infertility, Duke University School of Medicine, Durham, NC, USA.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-021-02301-2']
857,34461561,"The effects of a high eicosapentaenoic acid multinutrient supplement on measures of stress, anxiety and depression in young adults: Study protocol for NutriMOOD, a randomised double-blind placebo-controlled trial.","Anxiety disorders affect nearly 20% of young adults aged 18-29 years. First-line treatment for anxiety disorders comprises pharmacotherapy and Cognitive Behavioural Therapy, options often criticised for their low efficacy and safety. In contrast, fish-oil-based supplements comprising omega-3 polyunsaturated fatty acids and supporting nutrients are gaining recognition as safe and effective alternatives. Here we present the protocol for a randomised, double-blind, placebo-controlled trial investigating the effects of a high eicosapentaenoic acid multinutrient supplement on validated measures of anxiety and depression in healthy university students experiencing non-clinical levels of anxiety and depression. The primary outcome is improvement in anxiety compared to the placebo group assessed via the Generalised Anxiety Disorder Assessment-7 scale. The participants will be randomised to active treatment comprising a daily dose of 1125 mg eicosapentaenoic acid, 441 mg docosahexaenoic acid, 330 mg magnesium and 7.5 mg vitamin E, or placebo, for 24 weeks, and will complete validated questionnaires and tablet-based tasks sensitive to mood at baseline and end of intervention. Circulating fatty acids and key biomarkers will also be assessed. The students will be genotyped for polymorphisms thought to influence the relationship between long-chain omega-3 polyunsaturated fatty acids and affect. Trial registration; ClinicalTrials.gov, NCT04844034.",2021,The students will be genotyped for polymorphisms thought to influence the relationship between long-chain omega-3 polyunsaturated fatty acids and affect.,"['Anxiety disorders affect nearly 20% of young adults aged 18-29 years', 'young adults', 'healthy university students experiencing non-clinical levels of anxiety and depression']","['placebo', 'eicosapentaenoic acid, 441\xa0mg docosahexaenoic acid, 330\xa0mg magnesium and 7.5\xa0mg vitamin E, or placebo', 'eicosapentaenoic acid multinutrient supplement']","['Generalised Anxiety Disorder Assessment-7 scale', 'anxiety and depression', 'stress, anxiety and depression', 'anxiety']","[{'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.618616,The students will be genotyped for polymorphisms thought to influence the relationship between long-chain omega-3 polyunsaturated fatty acids and affect.,"[{'ForeName': 'Christos F', 'Initials': 'CF', 'LastName': 'Kelaiditis', 'Affiliation': 'School of Life and Health Sciences, University of Roehampton, London, UK. Electronic address: kelaidic@roehampton.ac.uk.'}, {'ForeName': 'E Leigh', 'Initials': 'EL', 'LastName': 'Gibson', 'Affiliation': 'School of Psychology, University of Roehampton, London, UK.'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Dyall', 'Affiliation': 'School of Life and Health Sciences, University of Roehampton, London, UK.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2021.102335']
858,34461298,A Care Coordination Intervention Improves Symptoms But Not Charges in High-Risk Patients With Inflammatory Bowel Disease.,"BACKGROUND


Inflammatory bowel disease (IBD) is associated with substantial symptom burden, variability in clinical outcomes, and high direct costs. We sought to determine if a care coordination-based strategy was effective at improving patient symptom burden and reducing healthcare costs for patients with IBD in the top quintile of predicted healthcare utilization and costs.
METHODS


We performed a randomized controlled trial to evaluate the efficacy of a patient-tailored multicomponent care coordination intervention composed of proactive symptom monitoring and care coordinator-triggered algorithms. Enrolled patients with IBD were randomized to usual care or to our care coordination intervention over a 9-month period (April 2019 to January 2020). Primary outcomes included change in patient symptom scores throughout the intervention and IBD-related charges at 12 months.
RESULTS


Eligible IBD patients in the top quintile for predicted healthcare utilization and expenditures were identified. A total of 205 patients were enrolled and randomized to our intervention (n = 100) or to usual care (n = 105). Patients in the care coordinator arm demonstrated an improvement in symptoms scores compared with usual care (coefficient, -0.68, 95% confidence interval, -1.18 to -0.18; P = .008) without a significant difference in median annual IBD-related healthcare charges ($10,094 vs $9080; P = .322).
CONCLUSIONS


In this first randomized controlled trial of a patient-tailored care coordination intervention, composed of proactive symptom monitoring and care coordinator-triggered algorithms, we observed an improvement in patient symptom scores but not in healthcare charges. Care coordination programs may represent an effective value-based approach to improve symptoms scores without added direct costs in a subgroup of high-risk patients with IBD. (ClinicalTrials.gov, Number: NCT04796571).",2021,"Patients in the care coordinator arm demonstrated an improvement in symptoms scores compared to usual care (coefficient -0.68, 95% CI, -1.18 to -0.18; p=.008) without a significant difference in median annual IBD-related healthcare charges ($10,094 vs $9,080, P=.322).
","['Enrolled patients with IBD', 'High-Risk Patients with Inflammatory Bowel Disease', 'patients with IBD in the top quintile of predicted healthcare utilization and costs', '205 patients were enrolled and randomized to our intervention (n=100) or usual care (n=105']","['usual care or to our care coordination intervention', 'Care Coordination Intervention', 'patient-tailored care coordination intervention', 'patient-tailored multicomponent care coordination intervention', 'proactive symptom monitoring and care coordinator-triggered algorithms']","['patient symptom scores', 'change in patient symptom scores throughout the intervention and IBD-related charges at 12 months', 'healthcare costs', 'median annual IBD-related healthcare charges', 'symptoms scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C4708569', 'cui_str': 'Care coordinator'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",205.0,0.0787737,"Patients in the care coordinator arm demonstrated an improvement in symptoms scores compared to usual care (coefficient -0.68, 95% CI, -1.18 to -0.18; p=.008) without a significant difference in median annual IBD-related healthcare charges ($10,094 vs $9,080, P=.322).
","[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Berinstein', 'Affiliation': 'Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan; Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan. Electronic address: jberinst@med.umich.edu.'}, {'ForeName': 'Shirley A', 'Initials': 'SA', 'LastName': 'Cohen-Mekelburg', 'Affiliation': 'Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan; Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Gillian M', 'Initials': 'GM', 'LastName': 'Greenberg', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Michigan, Detroit, Michigan.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wray', 'Affiliation': 'Twine Clinical Consulting, Park City, Utah.'}, {'ForeName': 'Sameer K', 'Initials': 'SK', 'LastName': 'Berry', 'Affiliation': 'Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan.'}, {'ForeName': 'Sameer D', 'Initials': 'SD', 'LastName': 'Saini', 'Affiliation': 'Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan; Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'A Mark', 'Initials': 'AM', 'LastName': 'Fendrick', 'Affiliation': 'Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan; Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan; Center for Value-Based Insurance Design, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Adams', 'Affiliation': 'Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan; Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Akbar K', 'Initials': 'AK', 'LastName': 'Waljee', 'Affiliation': 'Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan; Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Peter D R', 'Initials': 'PDR', 'LastName': 'Higgins', 'Affiliation': 'Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2021.08.034']
859,34455583,First-in-Human Study of Bamlanivimab in a Randomized Trial of Hospitalized Patients With COVID-19.,"Therapeutics for patients hospitalized with coronavirus disease 2019 (COVID-19) are urgently needed during the pandemic. Bamlanivimab is a potent neutralizing monoclonal antibody that blocks severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) attachment and entry into human cells, which could potentially lead to therapeutic benefit. J2W-MC-PYAA was a randomized, double-blind, sponsor unblinded, placebo-controlled, single ascending dose first-in-human trial (NCT04411628) in hospitalized patients with COVID-19. A total of 24 patients received either placebo or a single dose of bamlanivimab (700 mg, 2,800 mg, or 7,000 mg). The primary objective was assessment of safety and tolerability, including adverse events and serious adverse events, with secondary objectives of pharmacokinetic (PK) and pharmacodynamic analyses. Treatment-emergent adverse event (TEAE) rates were identical in the placebo and pooled bamlanivimab groups (66.7%). There were no apparent dose-related increases in the number or severity of TEAEs. There were no serious adverse events or deaths during the study, and no discontinuations due to adverse events. PKs of bamlanivimab is linear and exposure increased proportionally with dose following single i.v. administration. The half-life was ~ 17 days. These results demonstrate the favorable safety profile of bamlanivimab, and provided the initial critical evaluation of safety, tolerability, and PKs in support of the development of bamlanivimab in several ongoing clinical trials.",2021,"There were no serious adverse events or deaths during the study, and no discontinuations due to adverse events.","['Hospitalized Patients with COVID-19', 'patients hospitalized with COVID-19', 'hospitalized patients with COVID-19']","['bamlanivimab', 'placebo', 'Bamlanivimab']","['Treatment-emergent adverse event (TEAE) rates', 'serious adverse events or deaths', 'safety and tolerability, including adverse events and serious adverse events, with secondary objectives of pharmacokinetic (PK) and pharmacodynamic (PD) analyses', 'number or severity of TEAEs']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",24.0,0.507601,"There were no serious adverse events or deaths during the study, and no discontinuations due to adverse events.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.""}, {'ForeName': 'Gourab', 'Initials': 'G', 'LastName': 'Datta', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Grace Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Chien', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Price', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Chigutsa', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Brown-Augsburger', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Poorbaugh', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Fill', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Benschop', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Rouphael', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Kay', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': 'NYU Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': 'NYU Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Fischer', 'Affiliation': 'The University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dougan', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nirula', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Benson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2405']
860,34454810,Disease management with home telemonitoring aimed at substitution of usual care in the Netherlands: Post-hoc analyses of the e-Vita HF study.,"BACKGROUND


Home telemonitoring in heart failure (HF) patients may reduce workload of HF nurses by reducing face-to-face contacts. The aim of this study is to assess whether telemonitoring as a substitution could have negative effects as expressed by less reduction in circulating natriuretic peptide levels between baseline and one-year of follow up compared to usual care.
METHODS


A post-hoc analysis of the e-Vita HF trial, a three-arm parallel randomized trial conducted in stable HF patients. Patients were randomized into three arms: (i) usual HF outpatient care, (ii) usual care combined with the use of the website heartfailurematters.org, and (iii) telemonitoring (e-Vita HF platform) instead of face-to-face consultations. Mixed linear model analyses were applied to assess differences in the N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels between the three arms over a year.
RESULTS


A total of 223 participants could be included (mean age 67.1 ± 10.1 years, 27% women, New York Heart Association class I-IV; 39%, 38%, 14%, and 9%). The mean left ventricular ejection fraction was 35 ± 10%. The median of routine face-to-face contacts over a year was 1.0 lower (2.0 vs. 3.0) in the third arm compared with usual care. Median NT-proBNP levels did not significantly differ between the three arms.
CONCLUSION


In stable and optimally treated HF patients, telemonitoring causing a reduction of routine face-to-face contacts seems not to negatively affect hemodynamic status as measured by NT-proBNP levels over time.",2022,"Median NT-proBNP levels did not significantly differ between the three arms.
","['stable HF patients', '223 participants could be included (mean age 67.1\xa0±\xa010.1 years, 27% women, New York Heart Association class I-IV; 39%, 38%, 14%, and 9', 'heart failure (HF) patients']","['usual HF outpatient care, (ii) usual care combined with the use of the website heartfailurematters.org, and (iii) telemonitoring (e-Vita HF platform) instead of face-to-face consultations']","['mean left ventricular ejection fraction', 'Median NT-proBNP levels', 'median of routine face-to-face contacts', 'brain natriuretic peptide (NT-proBNP) levels', 'circulating natriuretic peptide levels']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0373745', 'cui_str': 'Vitamin A measurement'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0301817', 'cui_str': 'Prohormone'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}]",223.0,0.0275242,"Median NT-proBNP levels did not significantly differ between the three arms.
","[{'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Brons', 'Affiliation': 'Department of Cardiology, Division Heart and Lungs, University Medical Center Utrecht, P.O. Box 85500, Utrecht, GA 3508, the Netherlands. Electronic address: m.brons@umcutrecht.nl.'}, {'ForeName': 'Frans H', 'Initials': 'FH', 'LastName': 'Rutten', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Nicolaas P A', 'Initials': 'NPA', 'LastName': 'Zuithoff', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Marish I F J', 'Initials': 'MIFJ', 'LastName': 'Oerlemans', 'Affiliation': 'Department of Cardiology, Division Heart and Lungs, University Medical Center Utrecht, P.O. Box 85500, Utrecht, GA 3508, the Netherlands.'}, {'ForeName': 'Folkert W', 'Initials': 'FW', 'LastName': 'Asselbergs', 'Affiliation': 'Department of Cardiology, Division Heart and Lungs, University Medical Center Utrecht, P.O. Box 85500, Utrecht, GA 3508, the Netherlands; Faculty of Population Health Sciences, Institute of Cardiovascular Science, University College London, London, UK; Institute of Health Informatics, University College London, London, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Koudstaal', 'Affiliation': 'Department of Cardiology, Division Heart and Lungs, University Medical Center Utrecht, P.O. Box 85500, Utrecht, GA 3508, the Netherlands.'}]",Journal of cardiology,['10.1016/j.jjcc.2021.08.003']
861,34463929,"Intravenous magnesium sulfate for prevention of vancomycin plus piperacillin-tazobactam induced acute kidney injury in critically ill patients: An open-label, placebo-controlled, randomized clinical trial.","BACKGROUND


Recent studies have shown an increased risk of acute kidney injury (AKI) induced by vancomycin + piperacillin-tazobactam (VPT) combination. In this study, the efficacy of intravenous magnesium sulfate in prevention of VPT induced AKI in critically ill patients admitted to the ICU has been evaluated.
METHODS


In an open-label, placebo-controlled, randomized clinical trial, 72 adults (≥ 18 years old) who had indications to receive VPT as empiric therapy were assigned to the magnesium or control group in 1:1 ratio. Concomitant with VPT, intravenous infusion of magnesium sulfate was started for patients in the magnesium group. The target serum level of magnesium was defined 3 mg/dl. Patients in the control group received normal saline as placebo. The target serum level of magnesium was defined 1.9 mg/dl in this group. The study's primary outcome was incidence of AKI during and up to 48 h after the treatment course. Escalation and de-escalation of VPT regimen, duration of hospitalization, length of ICU stay and 28-day mortality were secondary outcomes.
RESULTS


Thirty patients in each group completed the examination. Five patients in the magnesium group and 11 patients in the control group experienced AKI (p = 0.072). De-escalation of VPT regimen was done approximately in 60% of patients. Duration of hospitalization and length of ICU stay were not statistically different between the groups. Finally, 28-day mortality was 23.33% in each group. Although the incidence of AKI was not statistically different between the groups in unadjusted logistic regression model, it became significant after adjusting for confounding factors [unadjusted model (OR = 0.34; 95% CI: 0.10-1.16, p = 0.084), adjusted model: (OR = 0.26; 95% CI: 0.07-0.96, p = 0.04)].
CONCLUSIONS


Administration of magnesium sulfate with the target serum levels around 3 mg/dL reduced the incidence of AKI in critically ill patients who were receiving VPT as empric therapy.",2021,Five patients in the magnesium group and 11 patients in the control group experienced AKI (p = 0.072).,"['critically ill patients who were receiving VPT as empric therapy', 'critically ill patients', 'critically ill patients admitted to the ICU', 'patients in the magnesium group', '72 adults (≥\u200918\xa0years old) who had indications to receive VPT as empiric therapy', 'Thirty patients in each group completed the examination']","['VPT, intravenous infusion of magnesium sulfate', 'magnesium sulfate', 'vancomycin plus piperacillin-tazobactam', 'normal saline as placebo', 'VPT', 'vancomycin\u2009+\u2009piperacillin-tazobactam (VPT) combination', 'magnesium or control', 'placebo', 'Intravenous magnesium sulfate', 'magnesium']","['incidence of AKI', 'target serum level of magnesium', 'incidence of AKI during and up to 48', '28-day mortality', 'duration of hospitalization, length of ICU stay and 28-day mortality', 'Duration of hospitalization and length of ICU stay']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0250480', 'cui_str': 'Piperacillin and tazobactam'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0250480', 'cui_str': 'Piperacillin and tazobactam'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",72.0,0.189401,Five patients in the magnesium group and 11 patients in the control group experienced AKI (p = 0.072).,"[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rahmani', 'Affiliation': 'Department of Pharmacotherapy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran. hmdrahmani89@gmail.com.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Intensive Care Unit, Faculty of Medicine, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mostafavi', 'Affiliation': 'General Intensive Care Unit, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]","Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences",['10.1007/s40199-021-00411-x']
862,34454637,"Study protocol: A stepped-wedge, cluster-randomized trial of the effectiveness of a deliberative loop in identifying implementation strategies for the adoption of a dental sealant guideline in dental clinics.","BACKGROUND


The American Dental Association (ADA) recommends dental providers apply dental sealants to the occlusal surfaces of permanent molars for the prevention or treatment of non-cavitated dental caries. Despite the evidence-based support for this guideline, adherence among general dentists is low, ranging from less than 5 to 38.5%. Thus, an evidence-to-practice gap exists, and it is unclear which implementation strategies would best support providers in adopting and implementing the evidence-based practice. One potential approach to selecting and tailoring implementation strategies is a deliberative loop process, a stakeholder-engaged approach to decision-making. This trial aims to test the acceptability, feasibility, and effectiveness of using a deliberative loop intervention with stakeholders (i.e., providers and staff) to enable managers to select implementation strategies that facilitate the adoption of an evidence-based dental practice.
METHODS


Sixteen dental clinics within Kaiser Permanente Northwest Dental will be cluster randomized to determine the timing of receiving the intervention in this stepped-wedge trial. In the three-part deliberative loop intervention, clinic stakeholders engage in the following activities: (1) receive background information, (2) participate in facilitated small-group discussions designed to promote learning from each other's lived experiences and develop informed opinions about effective clinic-level implementation strategies, and (3) share their informed opinions with clinic leaders, who may then choose to select and deploy implementation strategies based on the stakeholders' informed opinions. The primary outcome of Reach will be defined as patient-level receipt of guideline-concordant care. Secondary outcomes will include the cost-effectiveness, acceptability, and feasibility of the deliberative loop process. Implementation strategies deployed will be catalogued over time.
DISCUSSION


These results will establish the extent to which the deliberative loop process can help leaders select and tailor implementation strategies with the goal of improving guideline-concordant dental care.
TRIAL REGISTRATION


This project is registered at ClinicalTrials.gov with ID NCT04682730. The trial was first registered on 12/18/2020. https://clinicaltrials.gov/ct2/show/NCT04682730.",2021,"This trial aims to test the acceptability, feasibility, and effectiveness of using a deliberative loop intervention with stakeholders (i.e., providers and staff) to enable managers to select implementation strategies that facilitate the adoption of an evidence-based dental practice.
","['Sixteen dental clinics within Kaiser Permanente Northwest Dental', 'dental clinics']","[""background information, (2) participate in facilitated small-group discussions designed to promote learning from each other's lived experiences and develop informed opinions about effective clinic-level implementation strategies, and (3) share their informed opinions with clinic leaders, who may then choose to select and deploy implementation strategies based on the stakeholders' informed opinions"", 'deliberative loop']","['patient-level receipt of guideline-concordant care', 'cost-effectiveness, acceptability, and feasibility of the deliberative loop process', 'acceptability, feasibility, and effectiveness']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0011344', 'cui_str': 'Dental clinic'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0445022', 'cui_str': 'Loop'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",16.0,0.171261,"This trial aims to test the acceptability, feasibility, and effectiveness of using a deliberative loop intervention with stakeholders (i.e., providers and staff) to enable managers to select implementation strategies that facilitate the adoption of an evidence-based dental practice.
","[{'ForeName': 'Deborah E', 'Initials': 'DE', 'LastName': 'Polk', 'Affiliation': 'University of Pittsburgh School of Dental Medicine, Pittsburgh, PA, USA. dpolk@pitt.edu.'}, {'ForeName': 'Erick G', 'Initials': 'EG', 'LastName': 'Guerrero', 'Affiliation': 'Research to End Healthcare Disparities Corp, Los Angeles, CA, USA.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Gruß', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, USA.'}, {'ForeName': 'Nilesh H', 'Initials': 'NH', 'LastName': 'Shah', 'Affiliation': 'University of Pittsburgh School of Dental Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Nadia M', 'Initials': 'NM', 'LastName': 'Yosuf', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Dawson', 'Affiliation': 'The Art of Democracy, Pittsburgh, PA, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Kaplan', 'Affiliation': 'Charles D. Kaplan Consulting, LLC, Los Angeles, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Pihlstrom', 'Affiliation': 'Permanente Dental Associates, Portland, OR, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Fellows', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR, USA.'}]",Implementation science communications,['10.1186/s43058-021-00199-6']
863,34459702,A randomized phase II study comparing consolidation with a single dose of  90 Y ibritumomab tiuxetan  vs.  maintenance with rituximab for two years in patients with newly diagnosed follicular lymphoma responding to R-CHOP. Long-term follow-up results.,"This is a randomized phase-2 trial aimed to compare consolidation vs. maintenance in untreated patients with follicular lymphoma (FL) responding to induction. 146 patients were enrolled from 25 Spanish institutions (ZAR2007; ClinicalTrials.gov #NCT00662948). Patients in PR or CR/CR[u] after R-CHOP were randomized 1:1 to  90 Y-ibritumomab-tiuxetan 0.4 mCi/kg (arm A) vs. rituximab 375 mg/m 2  every 8 weeks for 2 years (arm B). After a median follow-up of 10.55 years, 53 patients eventually progressed with a 10-year PFS of 50% vs. 56% for patients in arm A and B, respectively (HR = 1.42;  p  > 0.1). No significant differences were seen in OS (10-year OS 78% vs. 84.5%; HR = 1.39,  p  > .1). Patients receiving  90 Y-ibritumomab-tiuxetan showed higher incidence of second neoplasms than those in arm B (10-year cumulative incidence 18.5 vs. 2%, respectively;  p  = .038). In conclusion, in FL patients responding to R-CHOP, no significant differences were found between consolidation and maintenance, although with higher late toxicity for consolidation.",2022,"No significant differences were seen in OS (10-year OS 78% vs. 84.5%; HR = 1.39,  p  > .1).","['untreated patients with follicular lymphoma (FL) responding to induction', '146 patients', 'patients with newly diagnosed follicular lymphoma responding to R-CHOP']","['90 Y ibritumomab tiuxetan  vs.  maintenance with rituximab', 'rituximab']","['10-year PFS', 'late toxicity', 'OS', 'incidence of second neoplasms']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}]","[{'cui': 'C0303596', 'cui_str': 'Yttrium-90'}, {'cui': 'C0877880', 'cui_str': 'ibritumomab tiuxetan'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085183', 'cui_str': 'Second Primary Neoplasms'}]",146.0,0.078975,"No significant differences were seen in OS (10-year OS 78% vs. 84.5%; HR = 1.39,  p  > .1).","[{'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'López-Guillermo', 'Affiliation': 'Hematopathology Department, Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Canales', 'Affiliation': 'Hematology Department, Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Dlouhy', 'Affiliation': 'Hematopathology Department, Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Mercadal', 'Affiliation': 'Catalan Institute of Oncology, Hospital Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Briones', 'Affiliation': 'Hospital de la Santa Creu y Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Martín García-Sancho', 'Affiliation': 'Hospital Clinico, Salamanca, Spain.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Sancho', 'Affiliation': 'Hematology Department, ICO-IJC-Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Moraleda', 'Affiliation': 'Hematology Department, Hospital V. Arraixaca, Murcia, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Terol', 'Affiliation': 'Department of Haematology and Medical Oncology, Hospital Clinico, Valencia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Salar', 'Affiliation': 'Hematology Department, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Palomera', 'Affiliation': 'Hematology Department, Hospital Clínico Lozano Blesa, Zaragoza, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Gardella', 'Affiliation': 'Catalan Institute of Oncology, Hospital Josep Trueta, Girona, Spain.'}, {'ForeName': 'Isidro', 'Initials': 'I', 'LastName': 'Jarque', 'Affiliation': 'Hematology Department, Hospital La Fe, CIBERONC - Instituto Carlos III, Valencia, Spain.'}, {'ForeName': 'Secundino', 'Initials': 'S', 'LastName': 'Ferrer', 'Affiliation': 'Hematology Department, Hospital Dr. Peset, Valencia, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bargay', 'Affiliation': 'Hospital Son Llatzer, Mallorca, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'López', 'Affiliation': ""Hematology Department, Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Panizo', 'Affiliation': 'Hematology Department, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Muntañola', 'Affiliation': 'Hematology Department, Hospital Universitari Mutua de Terrassa, Terrassa, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Montalbán', 'Affiliation': 'Internal Medicine, Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Eulogio', 'Initials': 'E', 'LastName': 'Conde', 'Affiliation': 'Department of Hematology, Hospital Universitario Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'Miguel T', 'Initials': 'MT', 'LastName': 'Hernández', 'Affiliation': 'Hematology Department, Hospital Universitario de Canarias, Tenerife, Spain.'}, {'ForeName': 'Alfons', 'Initials': 'A', 'LastName': 'Soler', 'Affiliation': 'Hematology Department, Hospital Parc Taulí, Sabadell, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'García Marco', 'Affiliation': 'Hospital Puerta de Hierro, Madrid, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Deben', 'Affiliation': 'Hematology Department, Hospital Juan Canalejo, La Coruña, Spain.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Marín', 'Affiliation': 'Hematology Department, Hospital Nuestra Señora de Aránzazu, San Sebastián, Spain.'}, {'ForeName': 'José Francisco', 'Initials': 'JF', 'LastName': 'Tomás', 'Affiliation': 'Hematology Department, MD Anderson Cancer Center, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia & lymphoma,['10.1080/10428194.2021.1971216']
864,34463696,Effect of Low-Normal vs High-Normal Oxygenation Targets on Organ Dysfunction in Critically Ill Patients: A Randomized Clinical Trial.,"Importance


Hyperoxemia may increase organ dysfunction in critically ill patients, but optimal oxygenation targets are unknown.
Objective


To determine whether a low-normal Pao2 target compared with a high-normal target reduces organ dysfunction in critically ill patients with systemic inflammatory response syndrome (SIRS).
Design, Setting, and Participants


Multicenter randomized clinical trial in 4 intensive care units in the Netherlands. Enrollment was from February 2015 to October 2018, with end of follow-up to January 2019, and included adult patients admitted with 2 or more SIRS criteria and expected stay of longer than 48 hours. A total of 9925 patients were screened for eligibility, of whom 574 fulfilled the enrollment criteria and were randomized.
Interventions


Target Pao2 ranges were 8 to 12 kPa (low-normal, n = 205) and 14 to 18 kPa (high-normal, n = 195). An inspired oxygen fraction greater than 0.60 was applied only when clinically indicated.
Main Outcomes and Measures


Primary end point was SOFARANK, a ranked outcome of nonrespiratory organ failure quantified by the nonrespiratory components of the Sequential Organ Failure Assessment (SOFA) score, summed over the first 14 study days. Participants were ranked from fastest organ failure improvement (lowest scores) to worsening organ failure or death (highest scores). Secondary end points were duration of mechanical ventilation, in-hospital mortality, and hypoxemic measurements.
Results


Among the 574 patients who were randomized, 400 (70%) were enrolled within 24 hours (median age, 68 years; 140 women [35%]), all of whom completed the trial. The median Pao2 difference between the groups was -1.93 kPa (95% CI, -2.12 to -1.74; P < .001). The median SOFARANK score was -35 points in the low-normal Pao2 group vs -40 in the high-normal Pao2 group (median difference, 10 [95% CI, 0 to 21]; P = .06). There was no significant difference in median duration of mechanical ventilation (3.4 vs 3.1 days; median difference, -0.15 [95% CI, -0.88 to 0.47]; P = .59) and in-hospital mortality (32% vs 31%; odds ratio, 1.04 [95% CI, 0.67 to 1.63]; P = .91). Mild hypoxemic measurements occurred more often in the low-normal group (1.9% vs 1.2%; median difference, 0.73 [95% CI, 0.30 to 1.20]; P < .001). Acute kidney failure developed in 20 patients (10%) in the low-normal Pao2 group and 21 patients (11%) in the high-normal Pao2 group, and acute myocardial infarction in 6 patients (2.9%) in the low-normal Pao2 group and 7 patients (3.6%) in the high-normal Pao2 group.
Conclusions and Relevance


Among critically ill patients with 2 or more SIRS criteria, treatment with a low-normal Pao2 target compared with a high-normal Pao2 target did not result in a statistically significant reduction in organ dysfunction. However, the study may have had limited power to detect a smaller treatment effect than was hypothesized.
Trial Registration


ClinicalTrials.gov Identifier: NCT02321072.",2021,"The median Pao2 difference between the groups was -1.93 kPa (95% CI, -2.12 to -1.74; P < .001).","['Critically Ill Patients', '574 patients who were randomized, 400 (70%) were enrolled within 24 hours (median age, 68 years; 140 women [35%]), all of whom completed the trial', 'critically ill patients', '9925 patients were screened for eligibility, of whom 574 fulfilled the enrollment criteria and were randomized', '4 intensive care units in the Netherlands', 'critically ill patients with 2 or more SIRS criteria', 'critically ill patients with systemic inflammatory response syndrome (SIRS', 'Enrollment was from February 2015 to October 2018, with end of follow-up to January 2019, and included adult patients admitted with 2 or more SIRS criteria and expected stay of longer than 48 hours']","['low-normal Pao2 target compared with a high-normal target', 'Low-Normal vs High-Normal Oxygenation Targets']","['organ dysfunction', 'Organ Dysfunction', 'nonrespiratory organ failure quantified by the nonrespiratory components of the Sequential Organ Failure Assessment (SOFA) score', 'Acute kidney failure', 'duration of mechanical ventilation, in-hospital mortality, and hypoxemic measurements', 'Mild hypoxemic measurements', 'acute myocardial infarction', 'median Pao2 difference', 'worsening organ failure or death', 'hospital mortality', 'median duration of mechanical ventilation']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439586', 'cui_str': '48 hours'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]","[{'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",9925.0,0.245398,"The median Pao2 difference between the groups was -1.93 kPa (95% CI, -2.12 to -1.74; P < .001).","[{'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Gelissen', 'Affiliation': 'Department of Intensive Care Medicine, Research VUmc Intensive Care, Amsterdam Cardiovascular Science, Amsterdam Infection and Immunity Institute, Amsterdam Medical Data Science, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Harm-Jan', 'Initials': 'HJ', 'LastName': 'de Grooth', 'Affiliation': 'Department of Intensive Care Medicine, Research VUmc Intensive Care, Amsterdam Cardiovascular Science, Amsterdam Infection and Immunity Institute, Amsterdam Medical Data Science, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Yvo', 'Initials': 'Y', 'LastName': 'Smulders', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Evert-Jan', 'Initials': 'EJ', 'LastName': 'Wils', 'Affiliation': 'Department of Intensive Care, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'de Ruijter', 'Affiliation': 'Department of Intensive Care, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Vink', 'Affiliation': 'Department of Intensive Care, Tergooiziekenhuizen, Hilversum, the Netherlands.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Smit', 'Affiliation': 'Department of Intensive Care Medicine, Research VUmc Intensive Care, Amsterdam Cardiovascular Science, Amsterdam Infection and Immunity Institute, Amsterdam Medical Data Science, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Jantine', 'Initials': 'J', 'LastName': 'Röttgering', 'Affiliation': 'Department of Intensive Care Medicine, Research VUmc Intensive Care, Amsterdam Cardiovascular Science, Amsterdam Infection and Immunity Institute, Amsterdam Medical Data Science, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Atmowihardjo', 'Affiliation': 'Department of Intensive Care Medicine, Research VUmc Intensive Care, Amsterdam Cardiovascular Science, Amsterdam Infection and Immunity Institute, Amsterdam Medical Data Science, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Armand', 'Initials': 'A', 'LastName': 'Girbes', 'Affiliation': 'Department of Intensive Care Medicine, Research VUmc Intensive Care, Amsterdam Cardiovascular Science, Amsterdam Infection and Immunity Institute, Amsterdam Medical Data Science, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Elbers', 'Affiliation': 'Department of Intensive Care Medicine, Research VUmc Intensive Care, Amsterdam Cardiovascular Science, Amsterdam Infection and Immunity Institute, Amsterdam Medical Data Science, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Pieter-Roel', 'Initials': 'PR', 'LastName': 'Tuinman', 'Affiliation': 'Department of Intensive Care Medicine, Research VUmc Intensive Care, Amsterdam Cardiovascular Science, Amsterdam Infection and Immunity Institute, Amsterdam Medical Data Science, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Oudemans-van Straaten', 'Affiliation': 'Department of Intensive Care Medicine, Research VUmc Intensive Care, Amsterdam Cardiovascular Science, Amsterdam Infection and Immunity Institute, Amsterdam Medical Data Science, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'de Man', 'Affiliation': 'Department of Intensive Care Medicine, Research VUmc Intensive Care, Amsterdam Cardiovascular Science, Amsterdam Infection and Immunity Institute, Amsterdam Medical Data Science, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}]",JAMA,['10.1001/jama.2021.13011']
865,34464517,"Pharmacokinetics, Safety, and Tolerability of the α 2C  -Adrenoreceptor Antagonist BAY 1193397 in Healthy Male Subjects.","The α 2C  -adrenoreceptor antagonist BAY 1193397 is in development for the oral treatment of diabetic foot ulcers. Safety, tolerability, and pharmacokinetics of BAY 1193397 were investigated in 3 randomized, single-center phase 1 studies in healthy male subjects: a first-in-human study (single oral doses of 0.5-50 mg), a relative bioavailability and food effect study (single doses of 1 and 10 mg), and a multiple-dose escalation study (using 2 and 5 mg twice daily and 10 and 20 mg once daily for 9 consecutive days). BAY 1193397 was rapidly absorbed in the fasted state, peak concentrations were reached between 0.6 and 2 hours. The mean terminal half-life was in the range of 17 to 20 hours. Area under the plasma concentration-time curve and maximum concentration appeared to be dose proportional, with a negligible food effect. There were no high-accumulation effects of BAY 1193397 after repeated dosing. BAY 1193397 was safe and well tolerated. At supratherapeutic plasma concentrations, there were slight transient increases in norepinephrine levels, heart rate, and blood pressure that were more pronounced after a single dose compared to steady state and appeared to be maximum concentration dependent. The results of the presented studies support the conduct of subsequent clinical trials with BAY 1193397 in patients with diabetes and compromised microcirculation.",2022,"At supratherapeutic plasma concentrations, there were slight transient increases in norepinephrine levels, heart rate, and blood pressure that were more pronounced after a single dose compared to steady state and appeared to be maximum concentration dependent.","['diabetic foot ulcers', 'healthy male subjects', 'Healthy Male Subjects', 'patients with diabetes and compromised microcirculation']",[],"['safe and well tolerated', 'plasma concentration-time curve and maximum concentration', 'norepinephrine levels, heart rate, and blood pressure', 'peak concentrations', 'Safety, tolerability, and pharmacokinetics', 'Pharmacokinetics, Safety, and Tolerability', 'mean terminal half-life']","[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",,0.0273688,"At supratherapeutic plasma concentrations, there were slight transient increases in norepinephrine levels, heart rate, and blood pressure that were more pronounced after a single dose compared to steady state and appeared to be maximum concentration dependent.","[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Kapsa', 'Affiliation': 'Clinical Pharmacokinetics, BAYER AG, Wuppertal, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Thuss', 'Affiliation': 'Bioanalytics, BAYER AG, Wuppertal, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Boxnick', 'Affiliation': 'CRS Clinical Research Services, Wuppertal GmbH, Wuppertal, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schaumann', 'Affiliation': 'CRS Clinical Research Services, Wuppertal GmbH, Wuppertal, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Schultz', 'Affiliation': 'CRS Clinical Research Services, Mannheim GmbH, Mannheim, Germany.'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Unger', 'Affiliation': 'Research and Early Development Statistics, BAYER AG, Wuppertal, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Otto', 'Affiliation': 'Clinical Experimentation Cardiovascular, BAYER AG, Wuppertal, Germany.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.1018']
866,34464490,"Directional effects of parent and child anxiety 1 year following treatment of child anxiety, and the mediational role of parent psychological control.","BACKGROUND


We leveraged a recent efficacy trial to investigate directionality between parent anxiety and child anxiety at posttreatment and 12-month follow-up, and the potential role of parent psychological control as a mediator. We also explored child age and sex as moderators.
METHOD


Two-hundred and fifty-four children were randomized to individual cognitive behavioral therapy (CBT) or to one of two CBT arms with parent involvement. Parent anxiety was not a treatment target in any of the three arms.
RESULTS


Child anxiety at posttreatment was associated with parent anxiety and psychological control at 12-month follow-up, providing evidence of child-to-parent directionality. Parent anxiety at posttreatment was associated indirectly with child anxiety at 12-month follow-up through associations with parent psychological control, providing evidence of parent-to-child directionality. At posttreatment, parent psychological control contemporaneously mediated the relation between parent and child anxiety. Neither child age nor sex moderated any association.
CONCLUSIONS


Findings highlight the directional effects between child anxiety, parent anxiety, and psychological control from posttreatment to 12-month follow-up, even when parent anxiety is not a treatment target. Research and clinical implications are discussed, with an emphasis on enhancing durability following treatment effects.",2021,"Parent anxiety at posttreatment was associated indirectly with child anxiety at 12-month follow-up through associations with parent psychological control, providing evidence of parent-to-child directionality.",['Two-hundred and fifty-four children'],['individual cognitive behavioral therapy (CBT'],"['Parent anxiety', 'child anxiety', 'parent anxiety and psychological control', 'parent anxiety and child anxiety']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",254.0,0.0431889,"Parent anxiety at posttreatment was associated indirectly with child anxiety at 12-month follow-up through associations with parent psychological control, providing evidence of parent-to-child directionality.","[{'ForeName': 'Wendy K', 'Initials': 'WK', 'LastName': 'Silverman', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Carla E', 'Initials': 'CE', 'LastName': 'Marin', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Rey', 'Affiliation': 'Department of Psychology, Florida International University, Miami, Florida, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jaccard', 'Affiliation': 'Silver School of Social Work, New York University, New York, New York, USA.'}, {'ForeName': 'Jeremy W', 'Initials': 'JW', 'LastName': 'Pettit', 'Affiliation': 'Department of Psychology, Florida International University, Miami, Florida, USA.'}]",Depression and anxiety,['10.1002/da.23210']
867,34464485,Transcranial direct current stimulation targeting the medial prefrontal cortex modulates functional connectivity and enhances safety learning in obsessive-compulsive disorder: Results from two pilot studies.,"BACKGROUND


Exposed-based psychotherapy is a mainstay of treatment for obsessive-compulsive disorder (OCD) and anxious psychopathology. The medial prefrontal cortex (mPFC) and the default mode network (DMN), which is anchored by the mPFC, promote safety learning. Neuromodulation targeting the mPFC might augment therapeutic safety learning and enhance response to exposure-based therapies.
METHODS


To characterize the effects of mPFC neuromodulation on functional connectivity, 17 community volunteers completed resting-state functional magnetic resonance imaging scans before and after 20 min of frontopolar anodal multifocal transcranial direct current stimulation (tDCS). To examine the effects of tDCS on therapeutic safety learning, 24 patients with OCD completed a pilot randomized clinical trial; they were randomly assigned (double-blind, 50:50) to receive active or sham frontopolar tDCS before completing an in vivo exposure and response prevention (ERP) challenge. Changes in subjective emotional distress during the ERP challenge were used to index therapeutic safety learning.
RESULTS


In community volunteers, frontal pole functional connectivity with the middle and superior frontal gyri increased, while connectivity with the anterior insula and basal ganglia decreased (ps < .001, corrected) after tDCS; functional connectivity between DMN and salience network also decreased after tDCS (ps < .001, corrected). OCD patients who received active tDCS exhibited more rapid therapeutic safety learning (ps < .05) during the ERP challenge than patients who received sham tDCS.
CONCLUSIONS


Frontopolar tDCS may modulate mPFC and DMN functional connectivity and can accelerate therapeutic safety learning. Though limited by small samples, these findings motivate further exploration of the effects of frontopolar tDCS on neural and behavioral targets associated with exposure-based psychotherapies.",2022,"OCD patients who received active tDCS exhibited more rapid therapeutic safety learning (ps < .05) during the ERP challenge than patients who received sham tDCS.
","['24 patients with OCD', 'obsessive-compulsive disorder', 'OCD patients who received', '17 community volunteers completed resting-state functional']","['Frontopolar tDCS', 'tDCS', 'frontopolar tDCS', 'Exposed-based psychotherapy', 'active tDCS', 'Transcranial direct current stimulation targeting the medial prefrontal cortex', 'active or sham frontopolar tDCS before completing an in vivo exposure and response prevention (ERP) challenge', 'mPFC neuromodulation', 'magnetic resonance imaging scans before and after 20\u2009min of frontopolar anodal multifocal transcranial direct current stimulation (tDCS']","['frontal pole functional connectivity', 'subjective emotional distress', 'connectivity with the anterior insula and basal ganglia', 'rapid therapeutic safety learning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}]","[{'cui': 'C0149546', 'cui_str': 'Structure of frontal pole'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0228259', 'cui_str': 'Anterior insula'}, {'cui': 'C0004781', 'cui_str': 'Basal ganglion structure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",24.0,0.0927078,"OCD patients who received active tDCS exhibited more rapid therapeutic safety learning (ps < .05) during the ERP challenge than patients who received sham tDCS.
","[{'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Adams', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Josh M', 'Initials': 'JM', 'LastName': 'Cisler', 'Affiliation': 'Department of Psychiatry, University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Kelmendi', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Jamilah R', 'Initials': 'JR', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Kichuk', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Averill', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Anticevic', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Chadi G', 'Initials': 'CG', 'LastName': 'Abdallah', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pittenger', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University, New Haven, Connecticut, USA.'}]",Depression and anxiety,['10.1002/da.23212']
868,34463700,Effect of Lower Tidal Volume Ventilation Facilitated by Extracorporeal Carbon Dioxide Removal vs Standard Care Ventilation on 90-Day Mortality in Patients With Acute Hypoxemic Respiratory Failure: The REST Randomized Clinical Trial.,"Importance


In patients who require mechanical ventilation for acute hypoxemic respiratory failure, further reduction in tidal volumes, compared with conventional low tidal volume ventilation, may improve outcomes.
Objective


To determine whether lower tidal volume mechanical ventilation using extracorporeal carbon dioxide removal improves outcomes in patients with acute hypoxemic respiratory failure.
Design, Setting, and Participants


This multicenter, randomized, allocation-concealed, open-label, pragmatic clinical trial enrolled 412 adult patients receiving mechanical ventilation for acute hypoxemic respiratory failure, of a planned sample size of 1120, between May 2016 and December 2019 from 51 intensive care units in the UK. Follow-up ended on March 11, 2020.
Interventions


Participants were randomized to receive lower tidal volume ventilation facilitated by extracorporeal carbon dioxide removal for at least 48 hours (n = 202) or standard care with conventional low tidal volume ventilation (n = 210).
Main Outcomes and Measures


The primary outcome was all-cause mortality 90 days after randomization. Prespecified secondary outcomes included ventilator-free days at day 28 and adverse event rates.
Results


Among 412 patients who were randomized (mean age, 59 years; 143 [35%] women), 405 (98%) completed the trial. The trial was stopped early because of futility and feasibility following recommendations from the data monitoring and ethics committee. The 90-day mortality rate was 41.5% in the lower tidal volume ventilation with extracorporeal carbon dioxide removal group vs 39.5% in the standard care group (risk ratio, 1.05 [95% CI, 0.83-1.33]; difference, 2.0% [95% CI, -7.6% to 11.5%]; P = .68). There were significantly fewer mean ventilator-free days in the extracorporeal carbon dioxide removal group compared with the standard care group (7.1 [95% CI, 5.9-8.3] vs 9.2 [95% CI, 7.9-10.4] days; mean difference, -2.1 [95% CI, -3.8 to -0.3]; P = .02). Serious adverse events were reported for 62 patients (31%) in the extracorporeal carbon dioxide removal group and 18 (9%) in the standard care group, including intracranial hemorrhage in 9 patients (4.5%) vs 0 (0%) and bleeding at other sites in 6 (3.0%) vs 1 (0.5%) in the extracorporeal carbon dioxide removal group vs the control group. Overall, 21 patients experienced 22 serious adverse events related to the study device.
Conclusions and Relevance


Among patients with acute hypoxemic respiratory failure, the use of extracorporeal carbon dioxide removal to facilitate lower tidal volume mechanical ventilation, compared with conventional low tidal volume mechanical ventilation, did not significantly reduce 90-day mortality. However, due to early termination, the study may have been underpowered to detect a clinically important difference.
Trial Registration


ClinicalTrials.gov Identifier: NCT02654327.",2021,"There were significantly fewer mean ventilator-free days in the extracorporeal carbon dioxide removal group compared with the standard care group (7.1 [95% CI, 5.9-8.3] vs 9.2 [95% CI, 7.9-10.4] days; mean difference, -2.1 [95% CI, -3.8 to -0.3]; P = .02).","['Patients With Acute Hypoxemic Respiratory Failure', 'patients with acute hypoxemic respiratory failure', '412 patients who were randomized (mean age, 59 years; 143 [35%] women), 405 (98%) completed the trial', 'for acute hypoxemic respiratory failure, of a planned sample size of 1120, between May 2016 and December 2019 from 51 intensive care units in the UK', '412 adult patients receiving']","['extracorporeal carbon dioxide removal', 'Lower Tidal Volume Ventilation Facilitated by Extracorporeal Carbon Dioxide Removal vs Standard Care Ventilation', 'lower tidal volume ventilation facilitated by extracorporeal carbon dioxide removal for at least 48 hours (n\u2009=\u2009202) or standard care with conventional low tidal volume ventilation', 'mechanical ventilation']","['22 serious adverse events', 'mean ventilator-free days', '90-day mortality', 'bleeding', 'intracranial hemorrhage', '90-Day Mortality', 'ventilator-free days at day 28 and adverse event rates', 'cause mortality', 'Serious adverse events', '90-day mortality rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0398339', 'cui_str': 'Extracorporeal carbon dioxide removal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}]",412.0,0.302932,"There were significantly fewer mean ventilator-free days in the extracorporeal carbon dioxide removal group compared with the standard care group (7.1 [95% CI, 5.9-8.3] vs 9.2 [95% CI, 7.9-10.4] days; mean difference, -2.1 [95% CI, -3.8 to -0.3]; P = .02).","[{'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'McNamee', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gillies', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Barrett', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, King's College London, United Kingdom.""}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tunnicliffe', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Young', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bentley', 'Affiliation': 'Manchester Academic Health Sciences Centre, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Brodie', 'Affiliation': 'Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Boyle', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Millar', 'Affiliation': 'Roslin Institute, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Szakmany', 'Affiliation': 'Department of Anaesthesia, Intensive Care and Pain Medicine, Division of Population Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bannard-Smith', 'Affiliation': 'Department of Critical Care, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Redmond P', 'Initials': 'RP', 'LastName': 'Tully', 'Affiliation': 'Department of Anaesthetics and Intensive Care, Royal Oldham Hospital, Northern Care Alliance, Oldham, United Kingdom.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Agus', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, United Kingdom.'}, {'ForeName': 'Clíona', 'Initials': 'C', 'LastName': 'McDowell', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, United Kingdom.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Jackson', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, United Kingdom.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2021.13374']
869,34461224,"Simvastatin modulates estrogen signaling in uterine leiomyoma via regulating receptor palmitoylation, trafficking and degradation.","Uterine leiomyomas or fibroids are the most common tumors of the female reproductive tract. Estrogen (E 2 ), a steroid-derived hormone, and its receptors (ERs), particularly ER-α, are important drivers for the development and growth of leiomyomas. We previously demonstrated that simvastatin, a drug used for hyperlipidemia, also possesses anti-leiomyoma properties. The aim of this work is to investigate the impact of simvastatin on ER-α signaling in leiomyoma cells, including its expression, downstream signaling, transcriptional activity, post-translational modification, trafficking and degradation. Primary and immortalized human uterine leiomyoma (HuLM) cells were used for in vitro experiments. Immunodeficient mice xenografted with human leiomyoma tissue explants were used for in vivo studies. Leiomyoma samples were obtained from patients enrolled in an ongoing double-blinded, phase II, randomized controlled trial. Here, we found that simvastatin significantly reduced E 2 -induced proliferation and PCNA expression. In addition, simvastatin reduced total ER-α expression in leiomyoma cells and altered its subcellular localization by inhibiting its trafficking to the plasma membrane and nucleus. Simvastatin also inhibited E 2  downstream signaling, including ERK and AKT pathways, E 2 /ER transcriptional activity and E 2 -responsive genes. To explain simvastatin effects on ER-α level and trafficking, we examined its effects on ER-α post-translational processing. We noticed that simvastatin reduced ER-α palmitoylation; a required modification for its stability, trafficking to plasma membrane, and signaling. We also observed an increase in ubiquitin-mediated ER-α degradation. Importantly, we found that the effects of simvastatin on ER-α expression were recapitulated in the xenograft leiomyoma mouse model and human tissues. Thus, our data suggest that simvastatin modulates several E 2 /ER signaling targets with potential implications in leiomyoma therapy and beyond.",2021,"In addition, simvastatin reduced total ER-α expression in leiomyoma cells and altered its subcellular localization by inhibiting its trafficking to the plasma membrane and nucleus.",[],"['simvastatin', 'Simvastatin']","['total ER-α expression', 'E 2 -induced proliferation and PCNA expression', 'ER-α expression', 'ubiquitin-mediated ER-α degradation', 'ER-α level and trafficking']",[],"[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0072108', 'cui_str': 'Antigen, Proliferating Cell Nuclear'}, {'cui': 'C0041538', 'cui_str': 'Ubiquitin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0883208,"In addition, simvastatin reduced total ER-α expression in leiomyoma cells and altered its subcellular localization by inhibiting its trafficking to the plasma membrane and nucleus.","[{'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Afrin', 'Affiliation': 'Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Malak', 'Initials': 'M', 'LastName': 'El Sabeh', 'Affiliation': 'Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Md Soriful', 'Initials': 'MS', 'LastName': 'Islam', 'Affiliation': 'Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Miyashita-Ishiwata', 'Affiliation': 'Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Minnie', 'Initials': 'M', 'LastName': 'Malik', 'Affiliation': 'Department of Obstetrics and Gynecology, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Catherino', 'Affiliation': 'Department of Obstetrics and Gynecology, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.'}, {'ForeName': 'Askar M', 'Initials': 'AM', 'LastName': 'Akimzhanov', 'Affiliation': 'Department of Biochemistry and Molecular Biology, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Boehning', 'Affiliation': 'Cooper Medical School of Rowan University, 401 Broadway, Camden, NJ 08103, USA.'}, {'ForeName': 'Qiwei', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Chicago School of Medicine, Chicago, IL 60637, USA.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Al-Hendy', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Chicago School of Medicine, Chicago, IL 60637, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Segars', 'Affiliation': 'Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Mostafa A', 'Initials': 'MA', 'LastName': 'Borahay', 'Affiliation': 'Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA. Electronic address: mboraha1@jhmi.edu.'}]",Pharmacological research,['10.1016/j.phrs.2021.105856']
870,34468913,Investigation of a Capnometry Guided Respiratory Intervention in the Treatment of Posttraumatic Stress Disorder.,"Evidence-based treatments for posttraumatic stress disorder (PTSD), including psychotherapies and medications, have high dropout and nonresponse rates, suggesting that more acceptable and effective treatments for PTSD are needed. Capnometry Guided Respiratory Intervention (CGRI) is a digital therapeutic effective in panic disorder that measures and displays end-tidal carbon dioxide (EtCO 2 ) and respiratory rate (RR) in real-time within a structured breathing protocol and may have benefit in PTSD by moderating breathing and EtCO 2  levels. We conducted a single-arm study of a CGRI system, Freespira®, to treat symptoms of PTSD. Participants with PTSD (n = 55) were treated for four weeks with twice-daily, 17-min at-home CGRI sessions using a sensor and tablet with pre-loaded software. PTSD and associated symptoms were assessed at baseline, end-of treatment, 2-months and 6-months post-treatment. Primary efficacy outcome was 50% of participants having ≥ 6-point decrease in Clinician Administered PTSD Scale (CAPS-5) score at 2-month follow up. Tolerability, usability, safety, adherence and patient satisfaction were assessed. CGRI was well tolerated, with 88% [95% CI 74-96%] having ≥ 6-point decrease in CAPS-5 scores at 2-months post-treatment follow up. Mean CAPS-5 scores decreased from 49.5 [s.d. = 9.2] at baseline to 27.1 [s.d. = 17.8] at 2-months post-treatment follow up. Respiratory rate decreased and EtCO 2  levels increased. Associated mental and physical health symptoms also improved. This CGRI intervention was safe, acceptable, and well-tolerated in improving symptoms in this study in PTSD. Further study against an appropriate comparator is warranted.Trial registration Clinicaltrials.gov NCT#03039231.",2021,"CGRI was well tolerated, with 88% [95% CI 74-96%] having ≥ 6-point decrease in CAPS-5 scores at 2-months post-treatment follow up.","['Participants with PTSD (n\u2009=\u200955', 'Posttraumatic Stress Disorder', 'posttraumatic stress disorder (PTSD']","['CGRI intervention', 'Capnometry Guided Respiratory Intervention (CGRI', 'Capnometry Guided Respiratory Intervention']","['Respiratory rate', 'Clinician Administered PTSD Scale (CAPS-5) score', 'PTSD and associated symptoms', 'Mean CAPS-5 scores', 'tolerated', 'CAPS-5 scores', 'Associated mental and physical health symptoms', 'Tolerability, usability, safety, adherence and patient satisfaction']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0376529', 'cui_str': 'Capnography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",,0.0449797,"CGRI was well tolerated, with 88% [95% CI 74-96%] having ≥ 6-point decrease in CAPS-5 scores at 2-months post-treatment follow up.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ostacher', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA. ostacher@stanford.edu.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Fischer', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Ellie R', 'Initials': 'ER', 'LastName': 'Bowen', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Jihun', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Denishia J', 'Initials': 'DJ', 'LastName': 'Robbins', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-021-09521-3']
871,34462286,"Effects of Spironolactone and Chlorthalidone on Cardiovascular Structure and Function in Chronic Kidney Disease: A Randomized, Open-Label Trial.","BACKGROUND AND OBJECTIVES


In a randomized double-blind, placebo-controlled trial, treatment with spironolactone in early-stage CKD reduced left ventricular mass and arterial stiffness compared with placebo. It is not known if these effects were due to BP reduction or specific vascular and myocardial effects of spironolactone.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


A prospective, randomized, open-label, blinded end point study conducted in four UK centers (Birmingham, Cambridge, Edinburgh, and London) comparing spironolactone 25 mg to chlorthalidone 25 mg once daily for 40 weeks in 154 participants with nondiabetic stage 2 and 3 CKD (eGFR 30-89 ml/min per 1.73 m 2 ). The primary end point was change in left ventricular mass on cardiac magnetic resonance imaging. Participants were on treatment with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and had controlled BP (target ≤130/80 mm Hg).
RESULTS


There was no significant difference in left ventricular mass regression; at week 40, the adjusted mean difference for spironolactone compared with chlorthalidone was -3.8 g (95% confidence interval, -8.1 to 0.5 g,  P =0.08). Office and 24-hour ambulatory BPs fell in response to both drugs with no significant differences between treatment. Pulse wave velocity was not significantly different between groups; at week 40, the adjusted mean difference for spironolactone compared with chlorthalidone was 0.04 m/s (-0.4 m/s, 0.5 m/s,  P =0.90). Hyperkalemia (defined ≥5.4 mEq/L) occurred more frequently with spironolactone (12 versus two participants, adjusted relative risk was 5.5, 95% confidence interval, 1.4 to 22.1,  P =0.02), but there were no patients with severe hyperkalemia (defined ≥6.5 mEq/L). A decline in eGFR >30% occurred in eight participants treated with chlorthalidone compared with two participants with spironolactone (adjusted relative risk was 0.2, 95% confidence interval, 0.05 to 1.1,  P =0.07).
CONCLUSIONS


Spironolactone was not superior to chlorthalidone in reducing left ventricular mass, BP, or arterial stiffness in nondiabetic CKD.",2021,"Spironolactone was not superior to chlorthalidone in reducing left ventricular mass, blood pressure or arterial stiffness in non-diabetic CKD.","['154 participants with non diabetic stage 2 and 3 chronic kidney disease (eGFR 30-89ml/min/1.73m 2 ', 'Chronic Kidney Disease', 'and had controlled blood pressure (target ≤130/80mmHg', 'early-stage chronic kidney disease']","['Spironolactone', 'angiotensin converting enzyme inhibitor or angiotensin receptor blocker', 'Spironolactone and Chlorthalidone', 'spironolactone 25mg to chlorthalidone', 'chlorthalidone', 'spironolactone', 'placebo']","['change in left ventricle mass on cardiac magnetic resonance', 'severe hyperkalemia', 'Hyperkalemia', 'eGFR', 'left ventricular mass regression', 'Office and 24-hour ambulatory blood pressures', 'Cardiovascular Structure and Function', 'Pulse wave velocity', 'left ventricular mass, blood pressure or arterial stiffness']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0990353', 'cui_str': 'Spironolactone 25 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0225897', 'cui_str': 'Left cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}]",154.0,0.216689,"Spironolactone was not superior to chlorthalidone in reducing left ventricular mass, blood pressure or arterial stiffness in non-diabetic CKD.","[{'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Edwards', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, United Kingdom Nicolaed@adhb.govt.co.nz.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Price', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, United Kingdom.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Hiemstra', 'Affiliation': 'Cambridge Clinical Trials Unit, Division of Experimental Medicine and Immunotherapeutics, University of Cambridge, United Kingdom.'}, {'ForeName': 'Amreen', 'Initials': 'A', 'LastName': 'Kaur', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, United Kingdom.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Webb', 'Affiliation': 'Center for Cardiovascular Science and Clinical Research Center, University of Edinburgh, United Kingdom.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Dhaun', 'Affiliation': 'Center for Cardiovascular Science and Clinical Research Center, University of Edinburgh, United Kingdom.'}, {'ForeName': 'Iain M', 'Initials': 'IM', 'LastName': 'MacIntyre', 'Affiliation': 'Center for Cardiovascular Science and Clinical Research Center, University of Edinburgh, United Kingdom.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Farrah', 'Affiliation': 'Center for Cardiovascular Science and Clinical Research Center, University of Edinburgh, United Kingdom.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Melville', 'Affiliation': 'Center for Cardiovascular Science and Clinical Research Center, University of Edinburgh, United Kingdom.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Herrey', 'Affiliation': ""UCL Institute of Cardiovascular Science and Department of Cardiology, Barts Heart Centre, St Bartholomew's Hospital, London, United Kingdom.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Slinn', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Wale', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ives', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Department of Renal Medicine, University College London, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Wilkinson', 'Affiliation': 'Cambridge Clinical Trials Unit, Division of Experimental Medicine and Immunotherapeutics, University of Cambridge, United Kingdom.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Steeds', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, United Kingdom.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ferro', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, United Kingdom.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Townend', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, United Kingdom.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.01930221']
872,34464752,Feasibility of a novel mixed-nutrient supplement in a multimodal prehabilitation intervention for lung cancer patients awaiting surgery: A randomized controlled pilot trial.,"OBJECTIVE


To investigate, in lung cancer patients awaiting elective surgery, the feasibility of delivering a novel four-week multimodal prehabilitation intervention and its effects on preoperative functional capacity and health-related quality of life (HRQoL), compared to standard hospital care.
METHODS


Adult patients awaiting elective thoracotomy for lung cancer stages I, II or IIIa, were approached to participate in an open-label, randomized controlled trial of two parallel arms: multimodal prehabilitation combining a mixed-nutrient supplement with structured supervised and home-based exercise training, and relaxation-strategies (Prehab) or standard hospital care (Control). Feasibility was assessed based on recruitment and adherence rates to the intervention and study outcome assessment. Functional capacity, measured by the 6-min walk test (6MWT), and HRQoL were measured at baseline and after four weeks (preoperative).
RESULTS


Within 5 months, 34 patients were enrolled and randomized (2:1) to Prehab (n = 24; median age = 67 years) or Control (n = 10; median age = 69 years); recruitment rate of 58.6%. The study was interrupted by the COVID-19 pandemic. Adherence to the prescribed intensity of the supervised exercise program was 84.1% (SD 23.1). Self-reported adherence to the home-based exercise program was 88.2% (SD 21) and to the nutritional supplement, 93.2% (SD 14.2). Adherence to patients' preoperative assessment was 82% and 88% in Prehab and Control, respectively. The mean adjusted difference in 4-week preoperative 6MWT between groups was 37.7 m (95% CI, -6.1 to 81.4), p = 0.089. There were no differences in HRQoL between groups.
CONCLUSION


Within a preoperative timeframe, it was feasible to deliver this novel multimodal prehabilitation intervention in lung cancer patients awaiting surgery.",2021,"Within a preoperative timeframe, it was feasible to deliver this novel multimodal prehabilitation intervention in lung cancer patients awaiting surgery.","['Adult patients awaiting elective thoracotomy for lung cancer stages', 'lung cancer patients awaiting elective surgery', '34 patients were enrolled and randomized (2:1) to Prehab (n\u202f=\u202f24; median age\u202f=\u202f67 years) or Control (n\u202f=\u202f10; median age\u202f=\u202f69 years); recruitment rate of 58.6', 'lung cancer patients awaiting surgery']","['multimodal prehabilitation combining a mixed-nutrient supplement with structured supervised and home-based exercise training, and relaxation-strategies (Prehab) or standard hospital care (Control', 'novel mixed-nutrient supplement']","['HRQoL', 'six-minute walk test (6MWT), and HRQoL', 'preoperative functional capacity and health-related quality of life (HRQoL']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",34.0,0.0935441,"Within a preoperative timeframe, it was feasible to deliver this novel multimodal prehabilitation intervention in lung cancer patients awaiting surgery.","[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Ferreira', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montreal, QC, Canada; Department of Anesthesia, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Lawson', 'Affiliation': 'School of Human Nutrition, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Department of Anesthesia, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Celena', 'Initials': 'C', 'LastName': 'Scheede-Bergdahl', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montreal, QC, Canada; Department of Anesthesia, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Chevalier', 'Affiliation': 'School of Human Nutrition, McGill University, Montreal, QC, Canada; Research Institute of the McGill University Health Centre, Montreal, QC, Canada. Electronic address: stephanie.chevalier@mcgill.ca.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2021.106079']
873,34460948,Phase 2a randomized clinical trial of dupilumab (anti-IL-4Rα) for alopecia areata patients.,"BACKGROUND


Treatments for alopecia areata (AA) patients with extensive scalp hair loss are limited, and recent evidence supports a role for type 2 T-cell (Th2)-immune response in AA. Dupilumab, a monoclonal antibody inhibiting Th2 signaling, approved for type 2 diseases including atopic dermatitis, was evaluated in AA patients.
METHODS


Alopecia areata patients with and without concomitant atopic dermatitis were randomized 2:1 to receive weekly subcutaneous dupilumab (300 mg) or placebo for 24 weeks, followed by another 24-week dupilumab open-label phase. The primary outcome was change from baseline in the Severity of Alopecia Tool (SALT) score at week 24; secondary outcomes included a range of measures of hair regrowth.
RESULTS


Forty and 20 patients were assigned to the dupilumab and placebo arms, respectively. At week 24, disease worsening was documented in the placebo arm, with a least-squares mean change in the SALT score of -6.5 (95% confidence-interval [CI], -10.4 to -2.6), versus a change of 2.2 (95% CI, -0.6 to 4.94) in the dupilumab arm (p < .05). After 48 weeks of dupilumab treatment, 32.5%, 22.5% and 15% of patients achieved SALT 30  /SALT 50  /SALT 75  improvement, respectively, while in patients with baseline IgE ≥ 200 IU/ml response rates increased to 53.8%, 46.2%, and 38.5%, respectively. Moreover, baseline IgE predicts treatment response with 83% accuracy. No new safety signals were detected.
CONCLUSIONS


This hypothesis-driven trial is the first to indicate the possible pathogenic role of the Th2 axis and Th2 targeting in AA patients. Patient selection based on baseline serum IgE levels may improve treatment results (Clinicaltrials.gov number, NCT03359356).",2022,"Dupilumab, a monoclonal antibody inhibiting Th2 signaling, approved for type 2 diseases including atopic dermatitis, was evaluated in AA patients.
","['alopecia areata (AA) patients with extensive scalp hair loss', '50', 'AA patients with and without concomitant atopic dermatitis', 'Forty and 20 patients', 'Alopecia Areata Patients']","['SALT 30  /SALT', 'Dupilumab (anti-IL-4Rα', 'placebo', 'subcutaneous dupilumab', 'dupilumab and placebo']","['range of measures of hair regrowth', 'disease worsening', 'SALT score', 'Severity of Alopecia Tool (SALT) score', 'ml response rates']","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0574769', 'cui_str': 'Loss of scalp hair'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.486761,"Dupilumab, a monoclonal antibody inhibiting Th2 signaling, approved for type 2 diseases including atopic dermatitis, was evaluated in AA patients.
","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Renert-Yuval', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bares', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Chima', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Hawkes', 'Affiliation': 'Department of Dermatology, UC Davis Medical Center, University of California Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Gilleaudeau', 'Affiliation': 'Laboratory for Investigative Dermatology, Rockefeller University, New York, NY, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sullivan-Whalen', 'Affiliation': 'Laboratory for Investigative Dermatology, Rockefeller University, New York, NY, USA.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Singer', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Garcet', 'Affiliation': 'Laboratory for Investigative Dermatology, Rockefeller University, New York, NY, USA.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Pavel', 'Affiliation': 'Department of Biomedical Engineering, University of Mississippi, Oxford, MS, USA.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Lebwohl', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'Laboratory for Investigative Dermatology, Rockefeller University, New York, NY, USA.'}]",Allergy,['10.1111/all.15071']
874,34470506,Confirmatory Efficacy of Cognitive Enhancement Therapy for Early Schizophrenia: Results From a Multisite Randomized Trial.,"OBJECTIVE


Cognitive enhancement therapy (CET) is an 18-month comprehensive cognitive remediation intervention designed to improve cognition and functioning among patients with schizophrenia. The current study sought to confirm previously observed benefits of CET on cognitive and behavioral outcomes in the early course of the condition in a large multisite trial.
METHODS


Overall, 102 outpatients with early-course schizophrenia were randomly assigned to 18 months of CET (N=58) or enriched supportive therapy (EST; N=44). Participants completed cognitive, social adjustment, and symptom assessments at baseline and at 9 and 18 months. Composite indices were calculated for these outcomes. Mixed-effects models investigated differential changes in outcomes between CET and EST. Because of a high attrition rate, sensitivity analyses of data from treatment completers (N=49) were conducted.
RESULTS


The effects of CET on improved overall cognition were confirmed and tentatively confirmed for social cognition in both intent-to-treat and completer analyses, and beneficial effects on attention/vigilance were also observed. An effect of CET on social adjustment was not confirmed in the analyses, because both CET and EST groups had considerably improved social adjustment. Although not statistically significant, the between-group effect size for CET's effect on social adjustment doubled from the intent-to-treat (Cohen's d=0.23) to completer analyses (Cohen's d=0.51) (p=0.057). Both groups displayed similar symptom improvements.
CONCLUSIONS


CET effectively improved cognition among patients with early-course schizophrenia. The functional benefits of CET appeared to increase with treatment retention. Further research is needed to understand predictors of attrition and mechanisms of change during CET for this population.",2021,"Although not statistically significant, the between-group effect size for CET's effect on social adjustment doubled from the intent-to-treat (Cohen's d=0.23) to completer analyses (Cohen's d=0.51) (p=0.057).","['Early Schizophrenia', '102 outpatients with early-course schizophrenia', 'patients with schizophrenia', 'patients with early-course schizophrenia']","['CET', 'CET and EST', 'CET (N=58) or enriched supportive therapy (EST', 'Cognitive enhancement therapy (CET', 'Cognitive Enhancement Therapy']","['social adjustment', 'overall cognition', 'social cognition', 'cognitive and behavioral outcomes']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",102.0,0.111538,"Although not statistically significant, the between-group effect size for CET's effect on social adjustment doubled from the intent-to-treat (Cohen's d=0.23) to completer analyses (Cohen's d=0.51) (p=0.057).","[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Wojtalik', 'Affiliation': 'Jack, Joseph and Morton Mandel School of Applied Social Sciences, Case Western Reserve University, Cleveland (Wojtalik); Massachusetts Mental Health Center Public Psychiatry Division of the Beth Israel Deaconess Medical Center, Boston (Mesholam-Gately, Sandoval, Shashidhar, Keshavan); Department of Psychiatry, Harvard Medical School, Boston (Mesholam-Gately, Sandoval, Guimond, Keshavan); Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh (Hogarty, Greenwald, Litschge, Eack); Department of Psychoeducation and Psychology, Université du Québec en Outaouais, Gatineau, Quebec, Canada (Guimond); School of Social Work, University of Pittsburgh, Pittsburgh (Eack).'}, {'ForeName': 'Raquelle I', 'Initials': 'RI', 'LastName': 'Mesholam-Gately', 'Affiliation': 'Jack, Joseph and Morton Mandel School of Applied Social Sciences, Case Western Reserve University, Cleveland (Wojtalik); Massachusetts Mental Health Center Public Psychiatry Division of the Beth Israel Deaconess Medical Center, Boston (Mesholam-Gately, Sandoval, Shashidhar, Keshavan); Department of Psychiatry, Harvard Medical School, Boston (Mesholam-Gately, Sandoval, Guimond, Keshavan); Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh (Hogarty, Greenwald, Litschge, Eack); Department of Psychoeducation and Psychology, Université du Québec en Outaouais, Gatineau, Quebec, Canada (Guimond); School of Social Work, University of Pittsburgh, Pittsburgh (Eack).'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Hogarty', 'Affiliation': 'Jack, Joseph and Morton Mandel School of Applied Social Sciences, Case Western Reserve University, Cleveland (Wojtalik); Massachusetts Mental Health Center Public Psychiatry Division of the Beth Israel Deaconess Medical Center, Boston (Mesholam-Gately, Sandoval, Shashidhar, Keshavan); Department of Psychiatry, Harvard Medical School, Boston (Mesholam-Gately, Sandoval, Guimond, Keshavan); Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh (Hogarty, Greenwald, Litschge, Eack); Department of Psychoeducation and Psychology, Université du Québec en Outaouais, Gatineau, Quebec, Canada (Guimond); School of Social Work, University of Pittsburgh, Pittsburgh (Eack).'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Greenwald', 'Affiliation': 'Jack, Joseph and Morton Mandel School of Applied Social Sciences, Case Western Reserve University, Cleveland (Wojtalik); Massachusetts Mental Health Center Public Psychiatry Division of the Beth Israel Deaconess Medical Center, Boston (Mesholam-Gately, Sandoval, Shashidhar, Keshavan); Department of Psychiatry, Harvard Medical School, Boston (Mesholam-Gately, Sandoval, Guimond, Keshavan); Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh (Hogarty, Greenwald, Litschge, Eack); Department of Psychoeducation and Psychology, Université du Québec en Outaouais, Gatineau, Quebec, Canada (Guimond); School of Social Work, University of Pittsburgh, Pittsburgh (Eack).'}, {'ForeName': 'Maralee Y', 'Initials': 'MY', 'LastName': 'Litschge', 'Affiliation': 'Jack, Joseph and Morton Mandel School of Applied Social Sciences, Case Western Reserve University, Cleveland (Wojtalik); Massachusetts Mental Health Center Public Psychiatry Division of the Beth Israel Deaconess Medical Center, Boston (Mesholam-Gately, Sandoval, Shashidhar, Keshavan); Department of Psychiatry, Harvard Medical School, Boston (Mesholam-Gately, Sandoval, Guimond, Keshavan); Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh (Hogarty, Greenwald, Litschge, Eack); Department of Psychoeducation and Psychology, Université du Québec en Outaouais, Gatineau, Quebec, Canada (Guimond); School of Social Work, University of Pittsburgh, Pittsburgh (Eack).'}, {'ForeName': 'Luis R', 'Initials': 'LR', 'LastName': 'Sandoval', 'Affiliation': 'Jack, Joseph and Morton Mandel School of Applied Social Sciences, Case Western Reserve University, Cleveland (Wojtalik); Massachusetts Mental Health Center Public Psychiatry Division of the Beth Israel Deaconess Medical Center, Boston (Mesholam-Gately, Sandoval, Shashidhar, Keshavan); Department of Psychiatry, Harvard Medical School, Boston (Mesholam-Gately, Sandoval, Guimond, Keshavan); Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh (Hogarty, Greenwald, Litschge, Eack); Department of Psychoeducation and Psychology, Université du Québec en Outaouais, Gatineau, Quebec, Canada (Guimond); School of Social Work, University of Pittsburgh, Pittsburgh (Eack).'}, {'ForeName': 'Gautami', 'Initials': 'G', 'LastName': 'Shashidhar', 'Affiliation': 'Jack, Joseph and Morton Mandel School of Applied Social Sciences, Case Western Reserve University, Cleveland (Wojtalik); Massachusetts Mental Health Center Public Psychiatry Division of the Beth Israel Deaconess Medical Center, Boston (Mesholam-Gately, Sandoval, Shashidhar, Keshavan); Department of Psychiatry, Harvard Medical School, Boston (Mesholam-Gately, Sandoval, Guimond, Keshavan); Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh (Hogarty, Greenwald, Litschge, Eack); Department of Psychoeducation and Psychology, Université du Québec en Outaouais, Gatineau, Quebec, Canada (Guimond); School of Social Work, University of Pittsburgh, Pittsburgh (Eack).'}, {'ForeName': 'Synthia', 'Initials': 'S', 'LastName': 'Guimond', 'Affiliation': 'Jack, Joseph and Morton Mandel School of Applied Social Sciences, Case Western Reserve University, Cleveland (Wojtalik); Massachusetts Mental Health Center Public Psychiatry Division of the Beth Israel Deaconess Medical Center, Boston (Mesholam-Gately, Sandoval, Shashidhar, Keshavan); Department of Psychiatry, Harvard Medical School, Boston (Mesholam-Gately, Sandoval, Guimond, Keshavan); Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh (Hogarty, Greenwald, Litschge, Eack); Department of Psychoeducation and Psychology, Université du Québec en Outaouais, Gatineau, Quebec, Canada (Guimond); School of Social Work, University of Pittsburgh, Pittsburgh (Eack).'}, {'ForeName': 'Matcheri S', 'Initials': 'MS', 'LastName': 'Keshavan', 'Affiliation': 'Jack, Joseph and Morton Mandel School of Applied Social Sciences, Case Western Reserve University, Cleveland (Wojtalik); Massachusetts Mental Health Center Public Psychiatry Division of the Beth Israel Deaconess Medical Center, Boston (Mesholam-Gately, Sandoval, Shashidhar, Keshavan); Department of Psychiatry, Harvard Medical School, Boston (Mesholam-Gately, Sandoval, Guimond, Keshavan); Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh (Hogarty, Greenwald, Litschge, Eack); Department of Psychoeducation and Psychology, Université du Québec en Outaouais, Gatineau, Quebec, Canada (Guimond); School of Social Work, University of Pittsburgh, Pittsburgh (Eack).'}, {'ForeName': 'Shaun M', 'Initials': 'SM', 'LastName': 'Eack', 'Affiliation': 'Jack, Joseph and Morton Mandel School of Applied Social Sciences, Case Western Reserve University, Cleveland (Wojtalik); Massachusetts Mental Health Center Public Psychiatry Division of the Beth Israel Deaconess Medical Center, Boston (Mesholam-Gately, Sandoval, Shashidhar, Keshavan); Department of Psychiatry, Harvard Medical School, Boston (Mesholam-Gately, Sandoval, Guimond, Keshavan); Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh (Hogarty, Greenwald, Litschge, Eack); Department of Psychoeducation and Psychology, Université du Québec en Outaouais, Gatineau, Quebec, Canada (Guimond); School of Social Work, University of Pittsburgh, Pittsburgh (Eack).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.202000552']
875,34472200,Pharmacokinetics of Flunarizine Hydrochloride After Single Oral Doses in Healthy Subjects: Bioequivalence Study and Food Effects.,"We designed a study to compare the newly developed 5-mg flunarizine hydrochloride capsules (test) to that of its marketed counterpart (5-mg; reference) among healthy adult Chinese volunteers. We performed an open-label, single-center study that consisted of 2 randomized, crossover trials, including a fasting trial and a fed trial. In each part of the study, the subjects were randomly assigned to either receive the test or reference products (5-mg flunarizine) in a 1:1 ratio. Subjects then received the alternative products, following a 14-day washout period. Concentrations of plasma flunarizine were analyzed using liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters (noncompartmental model) were evaluated using the WinNonlin software. The analysis of variance and Food and Drug Administration bioequivalence statistical criterion of 90% confidence interval for 80% to 125% range (set at P ≤ .05) of geometric means ratios of test: reference product for peak plasma concentration, area under the plasma concentration-time curve (AUC) from time 0 to time t, and AUC from time 0 to infinity were determined. Tolerability was evaluated during the entire study period. Overall, 23 volunteers completed the fasting study, while 40 volunteers completed the fed study. The test formulation was found to be bioequivalent to the marketed formulation, as the 90% confidence interval for the ratio of geometric means of peak plasma concentration (fasting: 87.61%-101.67%; fed: 87.38%-104.06%), AUC from time 0 to time t (fasting: 89.44%-99.92%; fed: 92.65%-98.28%), and AUC from time 0 to infinity (fasting: 95.02%-104.33%; fed: 90.41%-96.96%) were within equivalence limits (80-125%) under both the fasting and fed conditions. When flunarizine was given alongside high-fat meals, time to maximum concentration was delayed ≈3.5 hours compared to fasting conditions. Meantime, high-fat meals increased its exposure by nearly 50%. Furthermore, there were no serious adverse events found among the subjects. This study confirmed that test and reference flunarizine hydrochloride capsules were bioequivalent under fasting and postprandial conditions.",2022,"The test formulation was found to be bioequivalent to the marketed formulation, as the 90% confidence interval for the ratio of geometric means of peak plasma concentration (fasting: 87.61%-101.67%; fed: 87.38%-104.06%), AUC from time 0 to time t (fasting: 89.44%-99.92%; fed: 92.65%-98.28%), and AUC from time 0 to infinity (fasting: 95.02%-104.33%; fed: 90.41%-96.96%) were within equivalence limits (80-125%) under both the fasting and fed conditions.","['Healthy Subjects', 'healthy adult Chinese volunteers', '23 volunteers completed the fasting study, while 40 volunteers completed the fed study']","['Flunarizine Hydrochloride', 'flunarizine hydrochloride', 'reference products (5-mg flunarizine', 'flunarizine']","['peak plasma concentration', 'Tolerability', 'peak plasma concentration, area under the plasma concentration-time curve (AUC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0282181', 'cui_str': 'Flunarizine hydrochloride'}, {'cui': 'C0016295', 'cui_str': 'Flunarizine'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",23.0,0.0352709,"The test formulation was found to be bioequivalent to the marketed formulation, as the 90% confidence interval for the ratio of geometric means of peak plasma concentration (fasting: 87.61%-101.67%; fed: 87.38%-104.06%), AUC from time 0 to time t (fasting: 89.44%-99.92%; fed: 92.65%-98.28%), and AUC from time 0 to infinity (fasting: 95.02%-104.33%; fed: 90.41%-96.96%) were within equivalence limits (80-125%) under both the fasting and fed conditions.","[{'ForeName': 'Yan-Ying', 'Initials': 'YY', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiovascular Medicine, Xiangya Hospital, Central South University, Changsha, PR China.'}, {'ForeName': 'Zhi-Heng', 'Initials': 'ZH', 'LastName': 'Yi', 'Affiliation': 'Hunan Dinuo Pharmaceutical Co. Ltd., Changsha, PR China.'}, {'ForeName': 'Xiao-Min', 'Initials': 'XM', 'LastName': 'Li', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, PR China.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, PR China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': 'Hunan Dinuo Pharmaceutical Co. Ltd., Changsha, PR China.'}, {'ForeName': 'Yi-Xin', 'Initials': 'YX', 'LastName': 'Dai', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, PR China.'}, {'ForeName': 'Xue-Feng', 'Initials': 'XF', 'LastName': 'Zhong', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, PR China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, PR China.'}, {'ForeName': 'Ping-Sheng', 'Initials': 'PS', 'LastName': 'Xu', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, PR China.'}, {'ForeName': 'Su-Mei', 'Initials': 'SM', 'LastName': 'Xu', 'Affiliation': 'Phase Ⅰ Clinical Trial Center, Xiangya Hospital, Central South University, Changsha, PR China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.1012']
876,34472194,Effect of Transcodent painless needles on injection pain in maxillary anterior infiltration: a split-mouth controlled randomized clinical trial.,"OBJECTIVES


The present study aimed to determine the pain perceived during supraperiosteal (infiltration) injection in anterior maxillary region by Transcodent painless needle tips in comparison to the regular needle tips.
MATERIAL AND METHODS


In this split-mouth controlled randomised clinical trial, 30 patients were selected as candidates for cosmetic treatment who needed infiltration injections on both sides of canine area. They were each administered 0.9 mL of Lidocaine HCl 2% with epinephrine 1:100,000 in the buccal vestibules using two types of needle tips, Transcodent painless needle tip or regular needle tip. Immediately after the injection, the pain was measured using a 100 mm visual analog scale. The level of pain was statistically analyzed in the two groups using the parametric paired t-test. A 5% significance level was considered for statically significant difference between two means.
RESULTS


In accordance with the results, the patients' level of pain were estimated as 18.3 ± 10.7 mm with Transcodent painless needle tips and 43.1 ± 13.1 mm in regular needle tip (p < 0.05).
CONCLUSION


The Transcodent painless needle showed considerable reduction of pain in the anterior maxillary infiltration when compared to the regular needle tips.",2022,The Transcodent painless needle showed considerable reduction of pain in the anterior maxillary infiltration when compared to the regular needle tips.,"['30 patients were selected as candidates for cosmetic treatment who needed infiltration injections on both sides of canine area', 'maxillary anterior infiltration']","['Lidocaine HCl', 'epinephrine', 'pain perceived during supraperiosteal (infiltration) injection', 'Transcodent painless needles', 'Transcodent painless needle tip or regular needle tip']","['injection pain', 'pain', 'level of pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]","[{'cui': 'C0546869', 'cui_str': 'Lidocaine hydrochloride'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",30.0,0.260575,The Transcodent painless needle showed considerable reduction of pain in the anterior maxillary infiltration when compared to the regular needle tips.,"[{'ForeName': 'Farnoosh', 'Initials': 'F', 'LastName': 'Razmara', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arjang', 'Initials': 'A', 'LastName': 'Baghi', 'Affiliation': 'Private Practice, Tehran, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Afkhami', 'Affiliation': 'Department of Endodontics, School of Dentistry, Tehran University of Medical Sciences, International Campus, Tehran, Iran.'}]",Clinical and experimental dental research,['10.1002/cre2.475']
877,34477275,Pharmacokinetics of oral versus intravenous ibuprofen for closure of patent ductus arteriosus: A pilot randomised controlled study.,"AIM


This pilot study aimed to compare the pharmacokinetic profiles of oral (PO) and intravenous (IV) ibuprofen for treatment of patent ductus arteriosus (PDA) in preterm neonates.
METHODS


In a single-centre, parallel, randomised open-label trial, neonates ≤35 weeks, weight <1800 g with haemodynamically significant PDA during the first week of life were recruited between June 2017 and February 2019 and randomised to receive either PO or IV ibuprofen at standard dosage of 10, 5 and 5 mg/kg every 24 h for three consecutive days. Plasma concentrations of ibuprofen were quantified using a validated high-performance liquid chromatography method and pharmacokinetic parameters were calculated. Treatment outcomes were recorded.
RESULTS


Eleven neonates participated in the trial, six and five patients receiving PO and IV ibuprofen, respectively. Pharmacokinetic analysis reveals similar ibuprofen exposure levels in treatment groups. Median dose- and weight-normalised C max  values of PO and IV groups were 2.12 and 2.53 g/mL respectively (P = 0.082) and median AUC 0-24  levels were comparable (PO: 34.6 g*h/mL vs. IV: 50.7.6 g*h/mL, P = 0.25).
CONCLUSION


This exploratory study demonstrates comparable pharmacokinetics of PO and IV formulations of ibuprofen in preterm neonates. Larger prospective studies are required to validate these findings.",2022,Median dose- and weight-normalised C max  values of PO and IV groups were 2.12 and 2.53 g/mL respectively (P = 0.082) and median AUC 0-24  levels were comparable (PO: 34.6 g*h/mL vs. IV:,"['g with haemodynamically significant PDA during the first week of life were recruited between June 2017 and February 2019', 'patent ductus arteriosus (PDA) in preterm neonates', 'neonates ≤35\u2009weeks, weight <1800', 'Eleven neonates participated in the trial, six and five patients receiving', 'patent ductus arteriosus', 'preterm neonates']","['intravenous ibuprofen', 'ibuprofen', 'oral (PO) and intravenous (IV) ibuprofen', 'PO or IV ibuprofen', 'PO and IV ibuprofen']","['Plasma concentrations of ibuprofen', 'Median dose- and weight-normalised C max  values']","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",11.0,0.0864751,Median dose- and weight-normalised C max  values of PO and IV groups were 2.12 and 2.53 g/mL respectively (P = 0.082) and median AUC 0-24  levels were comparable (PO: 34.6 g*h/mL vs. IV:,"[{'ForeName': 'Priyantha Ebenezer', 'Initials': 'PE', 'LastName': 'Edison', 'Affiliation': 'Department of Neonatal & Developmental Medicine, The Academia, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Clinical Pharmacology Laboratory, Division of Cellular & Molecular Research, National Cancer Centre, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Cheo Lian', 'Initials': 'CL', 'LastName': 'Yeo', 'Affiliation': 'Department of Neonatal & Developmental Medicine, The Academia, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Allen', 'Affiliation': 'Centre for Quantitative Medicine, Office of Clinical Sciences, Duke NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Woei Bing', 'Initials': 'WB', 'LastName': 'Poon', 'Affiliation': 'Department of Neonatal & Developmental Medicine, The Academia, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Vijayendra R', 'Initials': 'VR', 'LastName': 'Baral', 'Affiliation': 'Department of Neonatal & Developmental Medicine, The Academia, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Balram', 'Initials': 'B', 'LastName': 'Chowbay', 'Affiliation': 'Clinical Pharmacology Laboratory, Division of Cellular & Molecular Research, National Cancer Centre, Singapore General Hospital, Singapore, Singapore.'}]",Journal of paediatrics and child health,['10.1111/jpc.15720']
878,34471087,Detection of an anti-angina therapeutic module in the effective population treated by a multi-target drug Danhong injection: a randomized trial.,"It's a challenge for detecting the therapeutic targets of a polypharmacological drug from variations in the responsed networks in the differentiated populations with complex diseases, as stable coronary heart disease. Here, in an adaptive, 31-center, randomized, double-blind trial involving 920 patients with moderate symptomatic stable angina treated by 14-day Danhong injection(DHI), a kind of polypharmacological drug with high quality control, or placebo (0.9% saline), with 76-day following-up, we firstly confirmed that DHI could increase the proportion of patients with clinically significant changes on angina-frequency assessed by Seattle Angina Questionnaire (ΔSAQ-AF ≥ 20) (12.78% at Day 30, 95% confidence interval [CI] 5.86-19.71%, P = 0.0003, 13.82% at Day 60, 95% CI 6.82-20.82%, P = 0.0001 and 8.95% at Day 90, 95% CI 2.06-15.85%, P = 0.01). We also found that there were no significant differences in new-onset major vascular events (P = 0.8502) and serious adverse events (P = 0.9105) between DHI and placebo. After performing the RNA sequencing in 62 selected patients, we developed a systemic modular approach to identify differentially expressed modules (DEMs) of DHI with the Z summary  value less than 0 compared with the control group, calculated by weighted gene co-expression network analysis (WGCNA), and sketched out the basic framework on a modular map with 25 functional modules targeted by DHI. Furthermore, the effective therapeutic module (ETM), defined as the highest correlation value with the phenotype alteration (ΔSAQ-AF, the change in SAQ-AF at Day 30 from baseline) calculated by WGCNA, was identified in the population with the best effect (ΔSAQ-AF ≥ 40), which is related to anticoagulation and regulation of cholesterol metabolism. We assessed the modular flexibility of this ETM using the global topological D value based on Euclidean distance, which is correlated with phenotype alteration (r 2 : 0.8204, P = 0.019) by linear regression. Our study identified the anti-angina therapeutic module in the effective population treated by the multi-target drug. Modular methods facilitate the discovery of network pharmacological mechanisms and the advancement of precision medicine. (ClinicalTrials.gov identifier: NCT01681316).",2021,We also found that there were no significant differences in new-onset major vascular events (P = 0.8502) and serious adverse events (P = 0.9105) between DHI and placebo.,"['62 selected patients', '920 patients with moderate symptomatic stable angina treated by 14-day Danhong injection(DHI), a kind of polypharmacological drug with high quality control, or']",['placebo (0.9% saline'],"['angina-frequency assessed by Seattle Angina Questionnaire (ΔSAQ-AF\u2009≥\u200920', 'serious adverse events', 'new-onset major vascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2715773', 'cui_str': 'danhong'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C3695257', 'cui_str': 'Frequency of angina'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",920.0,0.11449,We also found that there were no significant differences in new-onset major vascular events (P = 0.8502) and serious adverse events (P = 0.9105) between DHI and placebo.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Dan-Dan', 'Initials': 'DD', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yu-Qi', 'Initials': 'YQ', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Da-Xuan', 'Initials': 'DX', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Fu-Chun', 'Initials': 'FC', 'LastName': 'Zhang', 'Affiliation': 'Department of Geratology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Qiu', 'Affiliation': 'Department of Geratology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Hua', 'Affiliation': 'Department of Cardiology, Xuan Wu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing-Yu', 'Initials': 'JY', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, Xuan Wu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Bai', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Ting-Hai', 'Initials': 'TH', 'LastName': 'Du', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, China.'}, {'ForeName': 'Lin-Lin', 'Initials': 'LL', 'LastName': 'Niu', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, China.'}, {'ForeName': 'Xue-Jun', 'Initials': 'XJ', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Wuhan University Renmin Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Cui', 'Affiliation': 'Department of Cardiology, Wuhan University Renmin Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Jiang-Bin', 'Initials': 'JB', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Wuhan University Renmin Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Yang-Gan', 'Initials': 'YG', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Wuhan University Zhongnan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Hai-Rong', 'Initials': 'HR', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Wuhan University Zhongnan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Affiliated Zhongshan Hospital of Dalian University, Dalian, Liaoning, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Affiliated Zhongshan Hospital of Dalian University, Dalian, Liaoning, China.'}, {'ForeName': 'Yi-Lin', 'Initials': 'YL', 'LastName': 'Mao', 'Affiliation': 'Department of Cardiology, Second Affiliated Hospital to Hunan University of Chinese Medicine, Changsha, Hunan, China.'}, {'ForeName': 'Xiao-Fang', 'Initials': 'XF', 'LastName': 'Bin', 'Affiliation': 'Department of Cardiology, Second Affiliated Hospital to Hunan University of Chinese Medicine, Changsha, Hunan, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.'}, {'ForeName': 'Yu-Dan', 'Initials': 'YD', 'LastName': 'Tian', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.'}, {'ForeName': 'Qing-Hua', 'Initials': 'QH', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital to Shanxi Medical University, Taiyuan, Shanxi, China.'}, {'ForeName': 'Da-Jin', 'Initials': 'DJ', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital to Shanxi Medical University, Taiyuan, Shanxi, China.'}, {'ForeName': 'Li-Qin', 'Initials': 'LQ', 'LastName': 'Duan', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital to Shanxi Medical University, Taiyuan, Shanxi, China.'}, {'ForeName': 'Ming-Jun', 'Initials': 'MJ', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Affiliated Hospital of Shanxi University of Chinese Medicine, Xianyang, Shanxi, China.'}, {'ForeName': 'Cui-Ying', 'Initials': 'CY', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Affiliated Hospital of Shanxi University of Chinese Medicine, Xianyang, Shanxi, China.'}, {'ForeName': 'Hai-Ying', 'Initials': 'HY', 'LastName': 'Dai', 'Affiliation': 'Department of Cardiology, Changsha Central Hospital, Changsha, Hunan, China.'}, {'ForeName': 'Ze-Hua', 'Initials': 'ZH', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Changsha Central Hospital, Changsha, Hunan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Cardiology, Changsha Central Hospital, Changsha, Hunan, China.'}, {'ForeName': 'You-Zhi', 'Initials': 'YZ', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, Hubei, China.'}, {'ForeName': 'Xiao-Yu', 'Initials': 'XY', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, Hubei, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Xing', 'Affiliation': ""Department of Cardiology, Shanxi Provincial People's Hospital, Xi'an, Shanxi, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Department of Cardiology, Shanxi Provincial People's Hospital, Xi'an, Shanxi, China.""}, {'ForeName': 'Chao-Feng', 'Initials': 'CF', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Shanxi Province Hospital of Traditional Chinese Medicine, Xi'an, Shanxi, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'An', 'Affiliation': ""Department of Cardiology, Shanxi Province Hospital of Traditional Chinese Medicine, Xi'an, Shanxi, China.""}, {'ForeName': 'Feng-Chun', 'Initials': 'FC', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Xi'an City Hospital of Traditional Chinese Medicine, Xi'an, Shanxi, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Tao', 'Affiliation': ""Department of Cardiology, Xi'an City Hospital of Traditional Chinese Medicine, Xi'an, Shanxi, China.""}, {'ForeName': 'Jin-Fa', 'Initials': 'JF', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Shanghai Tongji Hospital, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Shanghai Tongji Hospital, Shanghai, China.'}, {'ForeName': 'Yao-Rong', 'Initials': 'YR', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiology, The First Hospital of Changsha, Changsha, Hunan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The First Hospital of Changsha, Changsha, Hunan, China.'}, {'ForeName': 'Shu-Wei', 'Initials': 'SW', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Xinhua Hospital of Zhejiang Province, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Dou', 'Affiliation': 'Department of Cardiology, Xinhua Hospital of Zhejiang Province, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Lan-Jun', 'Initials': 'LJ', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Zengchan Dao, Tianjin, China.'}, {'ForeName': 'Ying-Qiang', 'Initials': 'YQ', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Zengchan Dao, Tianjin, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Zengchan Dao, Tianjin, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': ""Department of Chinese medicine, Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Chinese medicine, Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Chongqing City Hospital of Traditional Chinese Medicine, Chongqing, China.'}, {'ForeName': 'Wen-Jin', 'Initials': 'WJ', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, Chongqing City Hospital of Traditional Chinese Medicine, Chongqing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Chongqing City Hospital of Traditional Chinese Medicine, Chongqing, China.'}, {'ForeName': 'Jian-Cong', 'Initials': 'JC', 'LastName': 'Tan', 'Affiliation': ""Department of Cardiology, Third People's Hospital of Chongqing, Chongqing, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Department of Cardiology, Third People's Hospital of Chongqing, Chongqing, China.""}, {'ForeName': 'Ya-Bin', 'Initials': 'YB', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, Harbin, Heilongjiang, China.'}, {'ForeName': 'Jian-Fei', 'Initials': 'JF', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, Harbin, Heilongjiang, China.'}, {'ForeName': 'Guo-Qing', 'Initials': 'GQ', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, Harbin, Heilongjiang, China.'}, {'ForeName': 'Hui-Jun', 'Initials': 'HJ', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, Harbin, Heilongjiang, China.'}, {'ForeName': 'He-Ping', 'Initials': 'HP', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Jilin Province People's Hospital, Changchun, Jilin, China.""}, {'ForeName': 'Zong-Wu', 'Initials': 'ZW', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Jilin Province People's Hospital, Changchun, Jilin, China.""}, {'ForeName': 'Jian-Xiong', 'Initials': 'JX', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Chengdu Second People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Xiao-Jia', 'Initials': 'XJ', 'LastName': 'Luo', 'Affiliation': ""Department of Cardiology, Chengdu Second People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Bin', 'Affiliation': ""Department of Cardiology, Chengdu Second People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Ya-Nan', 'Initials': 'YN', 'LastName': 'Yu', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Hai-Xia', 'Initials': 'HX', 'LastName': 'Dang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Teng', 'Affiliation': 'Beijing Genomics Institute (Shenzhen), Shenzhen, Guangdong, China.'}, {'ForeName': 'Wang-Min', 'Initials': 'WM', 'LastName': 'Qiao', 'Affiliation': 'Beijing Genomics Institute (Shenzhen), Shenzhen, Guangdong, China.'}, {'ForeName': 'Xiao-Long', 'Initials': 'XL', 'LastName': 'Zhu', 'Affiliation': 'Beijing Genomics Institute (Shenzhen), Shenzhen, Guangdong, China.'}, {'ForeName': 'Bing-Wei', 'Initials': 'BW', 'LastName': 'Chen', 'Affiliation': 'School of Public Health, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qi-Guang', 'Initials': 'QG', 'LastName': 'Chen', 'Affiliation': 'School of Public Health, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Chun-Ti', 'Initials': 'CT', 'LastName': 'Shen', 'Affiliation': 'Changzhou Hospital of Traditional Chinese Medicine, Changzhou, Jiangsu, China.'}, {'ForeName': 'Yong-Yan', 'Initials': 'YY', 'LastName': 'Wang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China. wangyongyan2010@sina.cn.'}, {'ForeName': 'Yun-Dai', 'Initials': 'YD', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China. cyundai@medmail.com.cn.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China. zhonw@vip.sina.com.'}]",Signal transduction and targeted therapy,['10.1038/s41392-021-00741-x']
879,34476847,Acute sleep loss alters circulating fibroblast growth factor 21 levels in humans: A randomised crossover trial.,"The hormone fibroblast growth factor 21 (FGF21) modulates tissue metabolism and circulates at higher levels in metabolic conditions associated with chronic sleep-wake disruption, such as type 2 diabetes and obesity. In the present study, we investigated whether acute sleep loss impacts circulating levels of FGF21 and tissue-specific production, and response pathways linked to FGF21. A total of 15 healthy normal-weight young men participated in a randomised crossover study with two conditions, sleep loss versus an 8.5-hr sleep window. The evening before each intervention, fasting blood was collected. Fasting, post-intervention morning skeletal muscle and adipose tissue samples underwent quantitative polymerase chain reaction and DNA methylation analyses, and serum FGF21 levels were measured before and after an oral glucose tolerance test. Serum levels of FGF21 were higher after sleep loss compared with sleep, both under fasting conditions and following glucose intake (~27%-30%, p = 0.023). Fasting circulating levels of fibroblast activation protein, a protein which can degrade circulating FGF21, were not altered by sleep loss, whereas DNA methylation in the FGF21 promoter region increased only in adipose tissue. However, even though specifically the muscle exhibited transcriptional changes indicating adverse alterations to redox and metabolic homeostasis, no tissue-based changes were observed in expression of FGF21, its receptors, or selected signalling targets, in response to sleep loss. In summary, we found that acute sleep loss resulted in increased circulating levels of FGF21 in healthy young men, which may occur independent of a tissue-based stress response in metabolic peripheral tissues. Further studies may decipher whether changes in FGF21 signalling after sleep loss modulate metabolic outcomes associated with sleep or circadian disruption.",2022,"Fasting circulating levels of fibroblast activation protein, a protein which can degrade circulating FGF21, were not altered by sleep loss, whereas DNA methylation in the FGF21 promoter region increased only in adipose tissue.","['humans', '15 healthy normal-weight young men', 'healthy young men']",['sleep loss versus an 8.5-hr sleep window'],"['serum FGF21 levels', 'circulating levels of FGF21', 'Serum levels of FGF21']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0235161', 'cui_str': 'Sleep loss'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0557702', 'cui_str': 'Window'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",15.0,0.0150057,"Fasting circulating levels of fibroblast activation protein, a protein which can degrade circulating FGF21, were not altered by sleep loss, whereas DNA methylation in the FGF21 promoter region increased only in adipose tissue.","[{'ForeName': 'Luiz Eduardo', 'Initials': 'LE', 'LastName': 'Mateus Brandão', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Espes', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jakub Orzechowski', 'Initials': 'JO', 'LastName': 'Westholm', 'Affiliation': 'Department of Biochemistry and Biophysics, National Bioinformatics Infrastructure Sweden, Science for Life Laboratory, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Martikainen', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Nestori', 'Initials': 'N', 'LastName': 'Westerlund', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Lampola', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Popa', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Vogel', 'Affiliation': 'Department of Experimental Diabetology, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Schürmann', 'Affiliation': 'Department of Experimental Diabetology, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany.'}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Dickson', 'Affiliation': 'Department of Physiology/Endocrinology, Institute of Neuroscience and Physiology, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Benedict', 'Affiliation': 'Department of Neuroscience, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cedernaes', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}]",Journal of sleep research,['10.1111/jsr.13472']
880,34475270,Baby's First Years: Design of a Randomized Controlled Trial of Poverty Reduction in the United States.,"Childhood economic disadvantage is associated with lower cognitive and social-emotional skills, reduced educational attainment, and lower earnings in adulthood. Despite these robust correlations, it is unclear whether family income is the cause of differences observed between children growing up in poverty and their more fortunate peers or whether these differences are merely due to the many other aspects of family life that co-occur with poverty. Baby's First Years is the first randomized controlled trial in the United States designed to identify the causal impact of poverty reduction on children's early development. A total of 1000 low-income mothers of newborns were enrolled in the study and began receiving a monthly unconditional cash gift for the first several years of their children's lives. Mothers were randomly assigned to receive either a large monthly cash gift or a nominal monthly cash gift. All monthly gifts are administered via debit card and can be freely spent with no restrictions. Baby's First Years aims to answer whether poverty reduction in early childhood (1) improves children's developmental outcomes and promotes healthier brain functioning, and (2) improves family functioning and better enables parents to support child development. Here we present the rationale and design of the study as well as potential implications for science and policy.",2021,Baby's First Years is the first randomized controlled trial in the United States designed to identify the causal impact of poverty reduction on children's early development.,"[""1000 low-income mothers of newborns were enrolled in the study and began receiving a monthly unconditional cash gift for the first several years of their children's lives"", ""Baby's First Years""]",['large monthly cash gift or a nominal monthly cash gift'],"['lower cognitive and social-emotional skills, reduced educational attainment']","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016999', 'cui_str': 'Gamete intrafallopian transfer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016999', 'cui_str': 'Gamete intrafallopian transfer'}]","[{'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}]",1000.0,0.146748,Baby's First Years is the first randomized controlled trial in the United States designed to identify the causal impact of poverty reduction on children's early development.,"[{'ForeName': 'Kimberly G', 'Initials': 'KG', 'LastName': 'Noble', 'Affiliation': 'Departments of Biobehavioral Sciences and Human Development, Teachers College, Columbia University, New York, New York kgn2106@tc.columbia.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Magnuson', 'Affiliation': 'Sandra Rosenbaum School of Social Work and.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Gennetian', 'Affiliation': 'Sanford School of Public Policy, Duke University, Durham, North Carolina.'}, {'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Duncan', 'Affiliation': 'School of Education, University of California, Irvine, Irvine, California.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Applied Psychology, New York University, New York, New York.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, Maryland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Halpern-Meekin', 'Affiliation': 'Department of Human Development and Family Studies and La Follette School of Public Affairs, University of Wisconsin-Madison, Madison, Wisconsin.'}]",Pediatrics,['10.1542/peds.2020-049702']
881,34476342,A Randomized Trial of Calcium Plus Vitamin D Supplementation and Risk of Ductal Carcinoma In Situ of the Breast.,"Background


The effect of calcium plus vitamin D (CaD) supplementation on risk of ductal carcinoma in situ (DCIS) of the breast, a nonobligate precursor of invasive ductal carcinoma, is not well understood. In this secondary analysis, we examined this association in the Women's Health Initiative CaD trial over approximately 20 years of follow-up.
Methods


A total of 36 282 cancer-free postmenopausal women (50-79 years) were randomly assigned to daily (d) calcium (1000 mg) plus vitamin D (400 IU) supplementation or to a placebo. Personal supplementation with vitamin D (≤600 IU/d, subsequently raised to 1000 IU/d) and calcium (≤1000 mg/d) was allowed. The intervention phase (median = 7.1 years), was followed by a postintervention phase (additional 13.8 years), which included 86.0% of the surviving women. A total of 595 incident DCIS cases were ascertained. Hazard ratios (HRs) plus 95% confidence intervals (CIs) were calculated.
Results


The intervention group had a lower risk of DCIS throughout follow-up (HR = 0.82, 95% CI = 0.70 to 0.96) and during the postintervention phase (HR = 0.76, 95% CI = 0.61 to 0.94). The group that used CaD personal supplements in combination with the trial intervention had a lower risk of DCIS compared with the trial placebo group that did not use personal supplementation (HR = 0.72, 95% CI = 0.56 to 0.91).
Conclusions


CaD supplementation in postmenopausal women was associated with reduced risk of DCIS, raising the possibility that consistent use of these supplements might provide long-term benefits for the prevention of DCIS.",2021,"The intervention group had a lower risk of DCIS throughout follow-up (HR = 0.82, 95% CI = 0.70 to 0.96) and during the postintervention phase (HR = 0.76, 95% CI = 0.61 to 0.94).","['ductal carcinoma in situ (DCIS) of the breast, a nonobligate precursor of invasive ductal carcinoma', 'Ductal Carcinoma', ""Women's Health Initiative CaD trial over approximately 20\u2009years of follow-up"", 'postmenopausal women', '36 282 cancer-free postmenopausal women (50-79\u2009years']","['Personal supplementation with vitamin D', 'calcium (1000\u2009mg) plus vitamin D (400\u2009IU) supplementation or to a placebo', 'calcium plus vitamin D (CaD) supplementation', 'calcium', 'placebo', 'Calcium Plus Vitamin D Supplementation']","['risk of DCIS', 'lower risk of DCIS']","[{'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C1134719', 'cui_str': 'Infiltrating ductular carcinoma'}, {'cui': 'C1176475', 'cui_str': 'Ductal Carcinoma'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]",36282.0,0.461034,"The intervention group had a lower risk of DCIS throughout follow-up (HR = 0.82, 95% CI = 0.70 to 0.96) and during the postintervention phase (HR = 0.76, 95% CI = 0.61 to 0.94).","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Peila', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Chlebowski', 'Affiliation': 'The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Nassir', 'Affiliation': 'Department of Pathology, College of Medicine, Umm Al-Qura University, Saudi Arabia.'}, {'ForeName': 'Nazmus', 'Initials': 'N', 'LastName': 'Saquib', 'Affiliation': 'College of Medicine at Sulaiman, Al Rajhi University, Sulaiman AlRajhi, Saudi Arabia.'}, {'ForeName': 'Aladdin H', 'Initials': 'AH', 'LastName': 'Shadyab', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Division of Oncological Science, Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Wassertheil-Smoller', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Rohan', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, USA.'}]",JNCI cancer spectrum,['10.1093/jncics/pkab072']
882,34474715,Bronchial provocation test measured by using the forced oscillation technique to assess airway responsiveness.,"Background:  The bronchial provocation test (BPT) performed by using the forced oscillation technique (FOT) is cooperated without forced expiratory effort. However, a comparison of the application value and safety of BPTs measured by using the FOT and the standardized dosimeter method is lacking, which limits its clinical practice.  Objective:  We aimed to analyze the diagnostic value and safety of the BPT as measured by the FOT in patients with asthma and in healthy subjects.  Methods:  This was a randomized cross-over clinical study. Airway responsiveness was measured by using the FOT and the aerosol provocation system (APS) dosimeter method in all the participants. The between-test interval was 24 hours. The diagnostic value and safety of the two tests were analyzed.  Results:  Asthma control status was assessed based on ACT scores, and patients with asthma (including 27 uncontrolled, 34 partially controlled, and 32 controlled) were collected, and 69 healthy subjects were recruited. Receiver operating characteristic curves revealed slightly superior screening capability of cumulative dose of methacholine causing a 20% decrease (PD 20 )-forced expiratory volume in the first second of expiration when measured by using the APS-dosimeter method (area under the curve [AUC] 0.981 [95% confidence interval {CI}, 0.952-1.000]) over that of cumulative dose of inhaled methacholine at the inflection point when respiratory resistance began to increase continuously (Dmin) by using the FOT (AUC 0.959 [95% CI, 0.924-0.994]). The sensitivity and specificity were 98.9% and 98.6%, respectively, with the APS-dosimeter method, and 100% and 87.0%, respectively, with the FOT. It took an average of 9.0 minutes (range, 6.0-11.0 minutes) when using the FOT and an average of 17.0 minutes (range, 14.0-25.0 minutes) when using APS-dosimeter method ( p  < 0.01) in all the participants. The measurement time for the FOT was reduced by 47.1% than the APS-dosimeter. The incidence rate of the adverse events with the FOT was slightly higher than that with the APS-dosimeter method ( p  < 0.05). Both tests were well tolerated. No serious adverse event was found.  Conclusion:  The FOT, characterized as being simple, safe, and time saving, could be used to assess airway hyperresponsiveness in patients with asthma and worthy of clinical application.",2021,The incidence rate of the adverse events with the FOT was slightly higher than that with the APS-dosimeter method ( p  < 0.05).,"['patients with asthma and in healthy subjects', 'patients with asthma (including 27 uncontrolled, 34 partially controlled, and 32 controlled) were collected, and 69 healthy subjects were recruited', 'patients with asthma and worthy of clinical application']","['bronchial provocation test (BPT) performed by using the forced oscillation technique (FOT', 'inhaled methacholine', 'methacholine']","['diagnostic value and safety', 'incidence rate of the adverse events with the FOT', 'Airway responsiveness', 'measurement time for the FOT', 'expiratory volume', 'tolerated', 'sensitivity and specificity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3853135', 'cui_str': 'Somewhat controlled'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0006265', 'cui_str': 'Bronchial provocation test'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0600370', 'cui_str': 'Methacholine'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",,0.0708446,The incidence rate of the adverse events with the FOT was slightly higher than that with the APS-dosimeter method ( p  < 0.05).,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ''}]",Allergy and asthma proceedings,['10.2500/aap.2021.42.210044']
883,34475522,Effects of the Fyn kinase inhibitor saracatinib on ventral striatal activity during performance of an fMRI monetary incentive delay task in individuals family history positive or negative for alcohol use disorder. A pilot randomised trial.,"Altered striatal regulation of the GluN2B subunit of N-methyl-D-aspartate (NMDA) glutamate receptors by the Fyn/Src family of protein tyrosine kinases has been implicated in animal alcohol consumption. Previously, we have described differences between individuals positive (FHP) and negative (FHN) for familial alcohol use disorder (AUD) in the ventral striatal (VS) activation associated with monetary incentive delay task (MIDT) performance during functional magnetic resonance imaging (fMRI). Here, we used AZD0530 (saracatinib), a centrally active Fyn/Src inhibitor to probe the role of Fyn/Src regulation of NMDA receptors (NMDAR) in VS activation differences between FHP and FHN individuals during fMRI MIDT performance. We studied 21 FHN and 22 FHP individuals, all without AUD. In two sessions, spaced 1 week apart, we administered 125 mg of saracatinib or placebo in a double-blind manner, prior to measuring VS signal during fMRI MIDT performance. MIDT comprises reward prospect, anticipation, and outcome phases. During the initial (prospect of reward) task phase, there was a significant group-by-condition interaction such that, relative to placebo, saracatinib reduced VS BOLD signal in FHP and increased it in FHN individuals. This study provides the first human evidence that elevated signaling in striatal protein kinase A-dependent pathways may contribute to familial AUD risk via amplifying the neural response to the prospect of reward. As Fyn kinase is responsible for NMDAR upregulation, these data are consistent with previous evidence for upregulated NMDAR function within reward circuitry in AUD risk. These findings also suggest a possible therapeutic role for Src/Fyn kinase inhibitors in AUD risk.",2022,"Previously, we have described differences between individuals positive (FHP) and negative (FHN) for familial alcohol use disorder (AUD) in the ventral striatal (VS) activation associated with monetary incentive delay task (MIDT) performance during functional magnetic resonance imaging (fMRI).","['21 FHN and 22 FHP individuals, all without AUD', 'individuals family history positive or negative for alcohol use disorder']","['Fyn kinase inhibitor saracatinib', 'saracatinib or placebo']","['ventral striatal activity', 'VS BOLD signal in FHP']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C1442788', 'cui_str': 'FYN protein, human'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2828242', 'cui_str': 'saracatinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",21.0,0.108749,"Previously, we have described differences between individuals positive (FHP) and negative (FHN) for familial alcohol use disorder (AUD) in the ventral striatal (VS) activation associated with monetary incentive delay task (MIDT) performance during functional magnetic resonance imaging (fMRI).","[{'ForeName': 'Krishna T', 'Initials': 'KT', 'LastName': 'Patel', 'Affiliation': 'Olin Neuropsychiatry Research Center, Institute of Living at Hartford Hospital, Hartford, CT, USA. krishnapancholi@gmail.com.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Stevens', 'Affiliation': 'Olin Neuropsychiatry Research Center, Institute of Living at Hartford Hospital, Hartford, CT, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Dunlap', 'Affiliation': 'Olin Neuropsychiatry Research Center, Institute of Living at Hartford Hospital, Hartford, CT, USA.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Gallagher', 'Affiliation': 'Olin Neuropsychiatry Research Center, Institute of Living at Hartford Hospital, Hartford, CT, USA.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'DeMartini', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Marc N', 'Initials': 'MN', 'LastName': 'Potenza', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Godfrey D', 'Initials': 'GD', 'LastName': 'Pearlson', 'Affiliation': 'Olin Neuropsychiatry Research Center, Institute of Living at Hartford Hospital, Hartford, CT, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-01157-5']
884,34470831,Comparison of Iron Dosing Strategies in Patients Undergoing Long-Term Hemodialysis: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


Whether iron supplementation in patients on hemodialysis could be delivered by less frequent but higher single doses compared with the currently more common higher-frequency schedules of lower single iron doses is unknown.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


We carried out an open-label, randomized, controlled noninferiority trial over 40 weeks in patients on prevalent hemodialysis ( n =142). We administered in total 2 g iron as 100 mg iron sucrose biweekly in a continuous (20 × 100 mg) fashion or 500 mg ferric carboxymaltose every 10 weeks in a periodic (4 × 500 mg) fashion. The primary end point was the change in hemoglobin at week 40 from baseline with a noninferiority margin of -0.8 g/dl. Secondary end points were changes in ferritin, transferrin, transferrin saturation, and erythropoiesis-stimulating agent use.
RESULTS


In total, 108 patients completed the study. At 40 weeks, hemoglobin changed by -0.27 g/dl (95% confidence interval, -0.64 to 0.09) in the iron sucrose arm and by -0.74 g/dl (95% confidence interval, -1.1 to -0.39) in the ferric carboxymaltose arm compared with baseline. Noninferiority was not established in the per-protocol population as hemoglobin changes compared with baseline differed by -0.47 g/dl (95% confidence interval, -0.95 to 0.01) in the ferric carboxymaltose arm compared with the iron sucrose arm. Proportional changes from baseline to week 40 differed by -31% (98.3% confidence interval, -52 to -0.1) for ferritin, by 1% (98.3% confidence interval, -7 to 10) for transferrin, and by -27% (98.3% confidence interval, -39 to -13) for transferrin saturation in the ferric carboxymaltose arm compared with the iron sucrose arm. Erythropoiesis-stimulating agent dosing did not differ between groups. The overall number of adverse events was similar; however, more infections were observed in the iron sucrose arm.
CONCLUSIONS


An equal cumulative dose of ferric carboxymaltose administered less frequently did not meet noninferiority for maintaining hemoglobin levels compared with iron sucrose administered more frequently.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients (COPEFER), NCT02198495.",2021,An equal cumulative dose of ferric carboxymaltose administered less frequently did not meet non-inferiority for maintaining hemoglobin levels compared to iron sucrose administered more frequently.,"['Patients Undergoing Long-Term Hemodialysis', 'prevalent hemodialysis patients (n=142', '108 patients completed the study', 'hemodialysis patients']",['ferric carboxymaltose'],"['changes in ferritin, transferrin, transferrin saturation and erythropoiesis stimulating agent use', 'hemoglobin changes', 'overall number of adverse events', 'change in hemoglobin', 'transferrin saturation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0449881', 'cui_str': 'Agent used'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.198723,An equal cumulative dose of ferric carboxymaltose administered less frequently did not meet non-inferiority for maintaining hemoglobin levels compared to iron sucrose administered more frequently.,"[{'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Bielesz', 'Affiliation': 'Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria bernhard.bielesz@meduniwien.ac.at.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Lorenz', 'Affiliation': 'Vienna Dialysis Center, Vienna, Austria.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Monteforte', 'Affiliation': 'Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Prikoszovich', 'Affiliation': 'Vienna Dialysis Center, Vienna, Austria.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Gabriel', 'Affiliation': 'Vienna Dialysis Center, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wolzt', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Gleiss', 'Affiliation': 'Center for Medical Statistics, Informatics, and Intelligent Systems, Institute of Clinical Biometrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Walter H', 'Initials': 'WH', 'LastName': 'Hörl', 'Affiliation': 'Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Gere', 'Initials': 'G', 'LastName': 'Sunder-Plassmann', 'Affiliation': 'Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.03850321']
885,34477931,Different endurance exercises modulate NK cell cytotoxic and inhibiting receptors.,"PURPOSE


Induction of IDO depends on the activation of AhR forming the AhR/IDO axis. Activated AhR can transcribe various target genes including cytotoxic and inhibiting receptors of NK cells. We investigated whether AhR and IDO levels as well as activating (NKG2D) and inhibiting (KIR2DL1) NK cell receptors are influenced by acute exercise and different chronic endurance exercise programs.
METHODS


21 adult breast and prostate cancer patients of the TOP study (NCT02883699) were randomized to intervention programs of 12 weeks of (1) endurance standard training or (2) endurance polarized training after a cardiopulmonary exercise test (CPET). Serum was collected pre-CPET, immediately post-CPET, 1 h post-CPET and after 12 weeks post-intervention. Flow cytometry analysis was performed on autologous serum incubated NK-92 cells for: AhR, IDO, KIR2DL1 and NKG2D. Differences were investigated using analysis-of-variance for acute and analysis-of-covariance for chronic effects.
RESULTS


Acute exercise: IDO levels changed over time with a significant increase from post-CPET to 1 h post-CPET (p = 0.03). KIR2DL1 levels significantly decreased over time (p < 0.01). NKG2D levels remained constant (p = 0.31). Chronic exercise: for both IDO and NKG2D a significant group × time interaction, a significant time effect and a significant difference after 12 weeks of intervention were observed (IDO: all p < 0.01, NKG2D: all p > 0.05).
CONCLUSION


Both acute and chronic endurance training may regulate NK cell function via the AhR/IDO axis. This is clinically relevant, as exercise emerges to be a key player in immune regulation.",2021,KIR2DL1 levels significantly decreased over time (p < 0.01).,['21 adult breast and prostate cancer patients of the TOP study (NCT02883699'],"['chronic endurance training', 'endurance standard training or (2) endurance polarized training\xa0after a cardiopulmonary exercise test (CPET']","['activating (NKG2D) and inhibiting (KIR2DL1', 'NKG2D levels', 'KIR2DL1 levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}]","[{'cui': 'C1430233', 'cui_str': 'KIR2DL1 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",21.0,0.0321925,KIR2DL1 levels significantly decreased over time (p < 0.01).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pal', 'Affiliation': 'Division of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Schlüter', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Steindorf', 'Affiliation': 'Division of Physical Activity, Prevention and Cancer, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wiskemann', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rosenberger', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Institute for Sport and Sport Science, Division of ""Performance and Health (Sports Medicine)"" , TU Dortmund University, August-Schmidt-Straße 4, 44227, Dortmund, Germany. philipp.zimmer@tu-dortmund.de.'}]",European journal of applied physiology,['10.1007/s00421-021-04735-z']
886,34478693,Disease Management in Skilled Nursing Facilities Improves Outcomes for Patients With a Primary Diagnosis of Heart Failure.,"OBJECTIVE


Skilled nursing facilities (SNFs) are common destinations after hospitalization for patients with heart failure (HF). Our objective was to determine if patients in SNFs with a primary hospital discharge diagnosis of HF benefit from an HF disease management program (HF-DMP).
DESIGN


This is a subgroup analysis of multisite, physician and practice blocked, cluster-randomized controlled trial of HF-DMP vs usual care for patients in SNF with an HF diagnosis. The HF-DMP standardized SNF HF care using HF practice guidelines and performance measures and was delivered by an HF nurse advocate.
SETTING AND PARTICIPANTS


Patients with a primary hospital discharge diagnosis of HF discharged to SNF.
METHODS


Composite outcome of all-cause hospitalization, emergency department visits, and mortality were evaluated at 30 and 60 days post SNF admission. Linear mixed models accounted for patient clustering at the physician level.
RESULTS


Of 671 individuals enrolled in the main study, 125 had a primary hospital discharge diagnosis of HF (50 HF-DMP; 75 usual care). Mean age was 79 ± 10 years, 53% women, and mean ejection fraction 46% ± 15%. At 60 days post SNF admission, the rate of the composite outcome was lower in the HF-DMP group (30%) compared with usual care (52%) (P = .02). The rate of the composite outcome at 30 days for the HF-DMP group was 18% vs 31% in the usual care group (P = .11).
CONCLUSIONS AND IMPLICATIONS


Patients with a primary hospital discharge diagnosis of HF who received HF-DMP while cared for in an SNF had lower rates of the composite outcome at 60 days. Standardized HF management during SNF stays may be important for patients with a primary discharge diagnosis of HF.",2022,"At 60 days post SNF admission, the rate of the composite outcome was lower in the HF-DMP group (30%) compared with usual care (52%)","['patients with a primary discharge diagnosis of HF', 'Mean age was 79 ± 10\xa0years, 53% women, and mean ejection fraction 46% ± 15', 'Patients with a primary hospital discharge diagnosis of HF who received', 'patients in SNF with an HF diagnosis', '671 individuals enrolled in the main study, 125 had a primary hospital discharge diagnosis of HF (50 HF-DMP; 75 usual care', 'Patients With a Primary Diagnosis of Heart Failure', 'patients with heart failure (HF', 'patients in SNFs with a primary hospital discharge diagnosis of HF benefit from an HF disease management program (HF-DMP', 'Patients with a primary hospital discharge diagnosis of HF discharged to SNF']",['HF-DMP'],"['rate of the composite outcome', 'cause hospitalization, emergency department visits, and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",671.0,0.202824,"At 60 days post SNF admission, the rate of the composite outcome was lower in the HF-DMP group (30%) compared with usual care (52%)","[{'ForeName': 'Himali', 'Initials': 'H', 'LastName': 'Weerahandi', 'Affiliation': 'Division of General Internal Medicine and Clinical Innovation, Department of Medicine, NYU Grossman School of Medicine, New York, NY, USA; Division of Healthcare Delivery Science, Department of Population Health, NYU Grossman School of Medicine, New York, NY, USA; Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, USA. Electronic address: Himali.Weerahandi@nyulangone.org.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Chaussee', 'Affiliation': 'Department of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Dodson', 'Affiliation': 'Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, USA; Leon H. Charney Division of Cardiology, Department of Medicine, NYU Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dolansky', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Boxer', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA; Division of Geriatric Medicine, University of Colorado, Aurora, CO, USA.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2021.08.002']
887,34478604,Long-term efficacy and complications of a multicentre randomised controlled trial comparing retropubic and transobturator mid-urethral slings: a prospective observational study.,"OBJECTIVE


There are concerns regarding the risks of mid-urethral slings (MUS) for stress urinary incontinence (SUI), particularly because of the lack of long-term data. We compare patient-reported outcomes of a multicentre randomised controlled trial of retropubic (TVT, GYNECARE™) versus transobturator (TOT, MONARC™) tape surgery at 12 years.
DESIGN AND SETTING


A multicentre study was performed in 11 tertiary referral centres.
POPULATION


A cohort of 180 participants from the original trial, the majority of whom had mixed urinary incontinence.
METHODS


Postal questionnaire survey of patient-reported outcome measures using the International Consultation on Incontinence Questionnaire, Patient Global Impression of Improvement questionnaire (PGI-I) and a numeric rating scale pain questionnaire.
MAIN OUTCOME MEASURES


Comparison of the efficacy and complications between the TVT and TOT procedures in the long term.
RESULTS


A total of 110/180 responses were received: 55 for TVT and 55 for TOT. The mean follow-up was 12.8 ± 0.29 years (SD). TVT was significantly superior to TOT: 41.8% TVT with no SUI, versus 21.8% TOT (P = 0.04). Urgency urinary incontinence (UUI) was the most bothersome urinary symptom: 14.5% of respondents reported UUI after TVT and TOT. This was an improvement from the baseline levels: 61.8% TVT and 76.4% TOT. Seventeen patients (9 TVT and 8 TOT) out of 121 reported moderate or severe pain with severe pain in 3 with TVT and 2 with TOT. Overall, 80% TVT and 77% TOT participants reported their symptoms as improved on the PGI-I.
CONCLUSIONS


TVT is superior to TOT for SUI cure. Efficacy is reduced by 12 years. There is low incidence of severe vaginal or groin pain. Careful patient counselling on long-term outcomes is required. The Retropubic tape appears to be an effective treatment for the majority of women with SUI.
TWEETABLE ABSTRACT


Retropubic tape has superior efficacy to transobturator tape. Complications are comparable with low rates.",2021,TVT was significantly superior to TOT,"['A multicentre study was performed in 11 tertiary referral centres', '180 participants from the original trial, the majority had mixed urinary incontinence', '17 respondents had severe or moderate pain: 9(14.3%)TVT and 8(13.8%)TOT']","['TOT', 'mid-urethral slings (MUS', 'MUS', 'TVT', 'retropubic (TVT-GYNECARE TM  ) versus transobturator (TOT-MONARC TM  ) tape surgery', 'Retropubic and Transobturator Mid-Urethral Slings']","['International Consultation on Incontinence Questionnaire, Patient Global Impression of Improvement questionnaire (PGI-I) and a Numeric rating scale pain questionnaire', 'efficacy and complications between the TVT and TOT procedures in the long term', 'Urgency urinary incontinence (UUI', 'Efficacy', 'Severe vaginal or groin pain']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}]","[{'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}]",180.0,0.104694,TVT was significantly superior to TOT,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Offiah', 'Affiliation': 'University of Plymouth, Plymouth, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'University Hospital Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16899']
888,34482319,Biomarker Analysis for Combination Therapy of Vitamin C and Thiamine in Septic Shock: A Post-Hoc Study of the ATESS Trial.,"INTRODUCTION


We evaluated the effects of vitamin C and thiamine administration on biomarkers in patients with septic shock.
METHODS


This was a post-hoc analysis of the Ascorbic Acid and Thiamine Effect in Septic Shock (ATESS) trial, a multicenter, double-blind, randomized controlled trial. Patients were randomized to either a treatment group (intravenous vitamin C and thiamine for 48 h) or a control group. Interleukin (IL)-6, IL-10, angiopoietin-II (AP2), and S100β were assessed at baseline and at 72 h. The primary outcomes were the biomarker levels at 72 h, and the secondary outcome was reduction rate.
RESULTS


Forty-five patients were assigned to the treatment group and 52 were assigned to the control group. Baseline biomarker levels and at 72 h were not significantly different between the treatment and the placebo groups. The reduction rates were not significantly different between the two groups. These outcome variables showed fair diagnostic accuracy for predicting 28-day mortality according to the area under the receiver operating characteristic curve.
CONCLUSION


Vitamin C and thiamine administration during the early phase of septic shock did not significantly change prognostic biomarker levels of IL-6, IL-10, AP2, and S100β.
TRIAL REGISTRATION


NCT, ClinicalTrials.gov NCT03756220, ATESS. Registered 28 November 2018, https://clinicaltrials.gov/ct2/show/NCT03756220.",2022,"These outcome variables showed fair diagnostic accuracy for predicting 28-day mortality according to the area under the receiver operating characteristic curve.
","['Forty-five patients', 'patients with septic shock']","['Vitamin C and Thiamine', 'treatment group (intravenous vitamin C and thiamine for 48\u200ah) or a control group', 'Vitamin C and thiamine', 'Ascorbic Acid and Thiamine', 'placebo', 'vitamin C and thiamine']","['biomarker levels at 72\u200ah', 'Baseline biomarker levels', 'Interleukin (IL)-6', 'reduction rates', 'IL-10, angiopoietin-II (AP2), and S100β', 'reduction rate']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1113649', 'cui_str': 'Angiopoietins'}]",45.0,0.868524,"These outcome variables showed fair diagnostic accuracy for predicting 28-day mortality according to the area under the receiver operating characteristic curve.
","[{'ForeName': 'Jong Eun', 'Initials': 'JE', 'LastName': 'Park', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'You Hwan', 'Initials': 'YH', 'LastName': 'Jo', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Sung Yeon', 'Initials': 'SY', 'LastName': 'Hwang', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Won Young', 'Initials': 'WY', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seung Mok', 'Initials': 'SM', 'LastName': 'Ryoo', 'Affiliation': 'Department of Emergency Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dong-Hyun', 'Initials': 'DH', 'LastName': 'Jang', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Taegyun', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Youn-Jung', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seonwoo', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Statistics and Data Center, Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'Statistics and Data Center, Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Gun Tak', 'Initials': 'GT', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung Phil', 'Initials': 'SP', 'LastName': 'Chung', 'Affiliation': 'Department of Emergency Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung-Hyuk', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Emergency Medicine, Guro Hospital, Korea University Medical Center, Seoul, Korea.'}, {'ForeName': 'Tae Gun', 'Initials': 'TG', 'LastName': 'Shin', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Gil Joon', 'Initials': 'GJ', 'LastName': 'Suh', 'Affiliation': 'Department of Emergency Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Shock (Augusta, Ga.)",['10.1097/SHK.0000000000001850']
889,34481017,Adding Short-Term Androgen Deprivation Therapy to Radiation Therapy in Men With Localized Prostate Cancer: Long-Term Update of the NRG/RTOG 9408 Randomized Clinical Trial.,"PURPOSE


For men with localized prostate cancer, NRG Oncology/Radiation Therapy Oncology Group (RTOG) 9408 demonstrated that adding short-term androgen deprivation therapy (ADT) to radiation therapy (RT) improved the primary endpoint of overall survival (OS) and improved disease-specific mortality (DSM), biochemical failure (BF), local progression, and freedom from distant metastases (DM). This study was performed to determine whether the short-term ADT continued to improve OS, DSM, BF, and freedom from DM with longer follow-up.
METHODS AND MATERIALS


From 1994 to 2001, NRG/RTOG 9408 randomized 2028 men from 212 North American institutions with T1b-T2b, N0 prostate adenocarcinoma and prostate-specific antigen (PSA) ≤20ng/mL to RT alone or RT plus short-term ADT. Patients were stratified by PSA, tumor grade, and surgical versus clinical nodal staging. ADT was flutamide with either goserelin or leuprolide for 4 months. Prostate RT (66.6 Gy) was started after 2 months. OS was calculated at the date of death from any cause or at last follow-up. Secondary endpoints were DSM, BF, local progression, and DM. Acute and late toxic effects were assessed using RTOG toxicity scales.
RESULTS


Median follow-up in surviving patients was 14.8 years (range, 0.16-21.98). The 10-year and 18-year OS was 56% and 23%, respectively, with RT alone versus 63% and 23% with combined therapy (HR 0.94; 95% confidence interval [CI], 0.85-1.05; P = .94). The hazards were not proportional (P = .003). Estimated restricted mean survival time at 18 years was 11.8 years (95% CI, 11.4-12.1) with combined therapy versus 11.3 years with RT alone (95% CI, 10.9-11.6; P = .05). The 10-year and 18-year DSM was 7% and 14%, respectively, with RT alone versus 3% and 8% with combined therapy (HR 0.56; 95% CI, 0.41-0.75; P < .01). DM and BF favored combined therapy at 18 years. Rates of late grade ≥3 hepatic, gastrointestinal, and genitourinary toxicity were ≤1%, 3%, and 8%, respectively, with combined therapy versus ≤1%, 2%, and 5% with RT alone.
CONCLUSIONS


Further follow-up demonstrates that OS converges at approximately 15 years, by which point the administration of 4 months of ADT had conferred an estimated additional 6 months of life.",2022,"and 18-year OS was 56% and 23% with RT-alone versus 63% and 23% with combined-therapy (HR 0.94, 95%CI: 0.85-1.05, p=0.94).","['From 1994-2001', 'men with localized prostate cancer', '2028 men from 212 North American institutions with T1b-T2b, N0 prostate adenocarcinoma and PSA≤20ng/mL to RT-alone or RT plus short-term ADT']","['goserelin or leuprolide', 'short-term Androgen deprivation therapy (ADT) to radiotherapy (RT', 'Adding short-term androgen deprivation therapy to RT']","['mean-survival-time', 'toxicity scales', '10-year and 18-year DSM', 'Rates of late grade ≥3 hepatic, gastrointestinal and genitourinary toxicity', 'OS, DSM, BF, and freedom from DM', 'overall-survival (OS) and also improved disease-specific-mortality (DSM), biochemical-failure (BF), local-progression (LP) and freedom from distant-metastases (DM', '10-year', 'DSM, BF, LP and DM', 'Acute and late toxic effects']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0475385', 'cui_str': 'Tumor stage T1b'}, {'cui': 'C0475388', 'cui_str': 'Tumor stage T2b'}, {'cui': 'C0007112', 'cui_str': 'Adenocarcinoma of prostate'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",2028.0,0.103893,"and 18-year OS was 56% and 23% with RT-alone versus 63% and 23% with combined-therapy (HR 0.94, 95%CI: 0.85-1.05, p=0.94).","[{'ForeName': 'Christopher U', 'Initials': 'CU', 'LastName': 'Jones', 'Affiliation': 'Sutter Medical Center Sacramento, Roseville, California. Electronic address: jonescu@sutterhealth.org.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Pugh', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chetner', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Mahul B', 'Initials': 'MB', 'LastName': 'Amin', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, Tennessee.'}, {'ForeName': 'Deborah W', 'Initials': 'DW', 'LastName': 'Bruner', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Zietman', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Den', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Leibenhaut', 'Affiliation': 'Sutter Medical Center Sacramento, Roseville, California.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Longo', 'Affiliation': 'Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Bahary', 'Affiliation': 'Centre Hospitalier De L`Université De Montréal-Notre Dame, Montréal, Quebec, Canada.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Rosenthal', 'Affiliation': 'Sutter Medical Center Sacramento, Roseville, California.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Souhami', 'Affiliation': 'The Research Institute of the McGill University Health Centre, Montréal, Quebec, Canada.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Michalski', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Hartford', 'Affiliation': 'Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Pradip P', 'Initials': 'PP', 'LastName': 'Amin', 'Affiliation': 'University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland.'}, {'ForeName': 'Mack', 'Initials': 'M', 'LastName': 'Roach', 'Affiliation': 'UCSF Medical Center-Mount Zion, San Francisco, California.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Yee', 'Affiliation': 'Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Efstathiou', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Rodgers', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'UCSF Medical Center-Mount Zion, San Francisco, California.'}, {'ForeName': 'William U', 'Initials': 'WU', 'LastName': 'Shipley', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, Massachusetts.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.08.031']
890,34483276,Effect of Azithromycin on the Ocular Surface Microbiome of Children in a High Prevalence Trachoma Area.,"PURPOSE


The aim of this study was to evaluate the effect of the 4 times per year mass azithromycin distributions on the ocular surface microbiome of children in a trachoma endemic area.
METHODS


In this cluster-randomized controlled trial, children aged 1 to 10 years in rural communities in the Goncha Seso Enesie district of Ethiopia were randomized to either no treatment or treatment with a single dose of oral azithromycin (height-based dosing to approximate 20 mg/kg) every 3 months for 1 year. Post hoc analysis of ocular surface Chlamydia trachomatis load, microbial community diversity, and macrolide resistance determinants was performed to evaluate differences between treatment arms.
RESULTS


One thousand two hundred fifty-five children from 24 communities were included in the study. The mean azithromycin coverage in the treated communities was 80% (95% CI: 73%-86%). The average age was 5 years (95% CI: 4-5). Ocular surface C. trachomatis load was reduced in children treated with the 4 times per year azithromycin (P = 0.0003). Neisseria gonorrhoeae, Neisseria lactamica, and Neisseria meningitidis were more abundant in the no-treatment arm compared with the treated arm. The macrolide resistance gene ermB was not different between arms (P = 0.63), but mefA/E was increased (P = 0.04) in the azithromycin-treated arm.
CONCLUSIONS


We found a reduction in the load of C. trachomatis and 3 Neisseria species in communities treated with azithromycin. These benefits came at the cost of selection for macrolide resistance.",2021,Ocular surface C. trachomatis load was reduced in children treated with the 4 times per year azithromycin (P = 0.0003).,"['Children in a High Prevalence Trachoma Area', 'children in a trachoma endemic area', 'children aged 1 to 10 years in rural communities in the Goncha Seso Enesie district of Ethiopia', 'One thousand two hundred fifty-five children from 24 communities were included in the study']","['Azithromycin', 'azithromycin distributions', 'azithromycin', 'oral azithromycin']","['macrolide resistance gene ermB', 'Ocular surface C. trachomatis load', 'mean azithromycin coverage', 'Neisseria gonorrhoeae, Neisseria lactamica, and Neisseria meningitidis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0040592', 'cui_str': 'Trachoma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0027573', 'cui_str': 'Neisseria gonorrhoeae'}, {'cui': 'C0317887', 'cui_str': 'Neisseria lactamica'}, {'cui': 'C0027571', 'cui_str': 'Neisseria'}]",1255.0,0.132823,Ocular surface C. trachomatis load was reduced in children treated with the 4 times per year azithromycin (P = 0.0003).,"[{'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, CA; Department of Ophthalmology, University of California San Francisco, CA; The Carter Center Ethiopia, Addis Ababa, Ethiopia; International Trachoma Initiative, Addis Ababa, Ethiopia; International Trachoma Initiative, Atlanta, GA; Department of Epidemiology and Biostatistics, University of California San Francisco, CA; and Institute for Global Health Sciences, University of California San Francisco, CA.'}, {'ForeName': 'Teshome', 'Initials': 'T', 'LastName': 'Gebre', 'Affiliation': ''}, {'ForeName': 'Berhan', 'Initials': 'B', 'LastName': 'Ayele', 'Affiliation': ''}, {'ForeName': 'Mulat', 'Initials': 'M', 'LastName': 'Zerihun', 'Affiliation': ''}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Hinterwirth', 'Affiliation': ''}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': ''}, {'ForeName': 'Cindi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Ruder', 'Affiliation': ''}, {'ForeName': 'Zhaoxia', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Emerson', 'Affiliation': ''}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': ''}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': ''}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': ''}]",Cornea,['10.1097/ICO.0000000000002863']
891,34483247,Evaluating the Efficacy of Intratympanic Dexamethasone in Protecting Against Irreversible Hearing Loss in Patients on Cisplatin-Based Cancer Treatment: A Randomized Controlled Phase IIIB Clinical Trial.,"OBJECTIVE


To determine the efficacy of long-term high-dose intratympanic dexamethasone in protecting the hearing capacity of cancer patients undergoing cisplatin-based ototoxic treatment.
DESIGN


A randomized controlled phase IIIB clinical trial to evaluate the efficacy of dexamethasone in protecting against hearing loss in patients undergoing cisplatin treatment. The subjects participating in the clinical trial were patients with a neoplastic disease whose treatment protocol included cisplatin. The average dose of cisplatin was 444.87 mg (SD 235.2 mg). Treatment consisted of intratympanically administering dexamethasone via a passive diffusion device called Microwick (8 mg/24 h dose) from the start of treatment with cisplatin to 3 weeks after the last cycle. Patients were administered the medication to one ear, and the contralateral ear was used as the control. The treated ears were randomly chosen using a computer system (randomization). The hearing threshold was evaluated using pure tone audiometry before each cisplatin cycle.
RESULTS


Thirty-four patients were recruited over a 2-year period at a reference tertiary hospital, of whom 11 were excluded. Forty-six ears were analyzed (23 treated and 23 control ears). When treatment was completed, the audiometric analysis showed a higher hearing threshold in the study group than in the control group. Differences were statistically significant at frequencies of 500, 1000, and 6000 Hz: 4.9 dB (1.1 to 8.7), 5.5 dB (0.8 to 10.3), and 16 dB (3.2 to 28.7), respectively, (p < 0.05, 95% confidence interval), but were not clinically significant according to the ASHA hearing loss criteria. Both 8.69% infection complications during treatment and 34.8% permanent perforation at 6 mo were detected after device removal.
CONCLUSIONS


Long-term high-dose intratympanic dexamethasone treatment did not prevent cisplatin-induced hearing loss.",2021,"When treatment was completed, the audiometric analysis showed a higher hearing threshold in the study group than in the control group.","['subjects participating in the clinical trial were patients with a neoplastic disease whose treatment protocol included', 'patients undergoing cisplatin treatment', 'cancer patients undergoing cisplatin-based ototoxic treatment', 'Patients on Cisplatin-Based Cancer Treatment', 'Forty-six ears were analyzed (23 treated and 23 control ears', 'Thirty-four patients were recruited over a 2-year period at a reference tertiary hospital, of whom 11 were excluded']","['Intratympanic Dexamethasone', 'long-term high-dose intratympanic dexamethasone', 'cisplatin', 'dexamethasone']","['hearing loss', 'infection complications']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",34.0,0.0983629,"When treatment was completed, the audiometric analysis showed a higher hearing threshold in the study group than in the control group.","[{'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Moreno', 'Affiliation': 'Department of Otolaryngology, Villarrobledo General Hospital, Albacete, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Belinchon', 'Affiliation': 'Department of Otolaryngology, University Hospital Complex of Albacete, Albacete, Spain.'}]",Ear and hearing,['10.1097/AUD.0000000000001119']
892,34485814,Cancer Antigen 15-3/Mucin 1 Levels in CCTG MA.32: A Breast Cancer Randomized Trial of Metformin vs Placebo.,"Background


Circulating levels of cancer antigen (CA) 15-3, a tumor marker and regulator of cellular metabolism, were reduced by metformin in a nonrandomized neoadjuvant study. We examined the effects of metformin (vs placebo) on CA 15-3 in participants of MA.32, a phase III randomized trial in early-stage breast cancer.
Methods


A total of 3649 patients with T1-3, N0-3, M0 breast cancer were randomly assigned; pretreatment and 6-month on-treatment fasting plasma were centrally assayed for CA 15-3. Genomic DNA was analyzed for the rs11212617 single nucleotide polymorphism. Absolute and relative change of CA 15-3 (metformin vs placebo) were compared using Wilcoxon rank and  t  tests. Regression models adjusted for baseline differences and assessed key interactions. All statistical tests were 2-sided.
Results


Mean (SD) age was 52.4 (10.0) years. The majority of patients had T2/3, node-positive, hormone receptor-positive, HER2-negative breast cancer treated with (neo)adjuvant chemotherapy and hormone therapy. Mean (SD) baseline CA 15-3 was 17.7 (7.6) and 18.0 (8.1 U/mL). At 6 months, CA 15-3 was statistically significantly reduced in metformin vs placebo arms (absolute geometric mean reduction in CA 15-3 = 7.7% vs 2.0%,  P  <   .001; relative metformin: placebo level of CA 15-3 [adjusted for age, baseline body mass index, and baseline CA 15-3] = 0.94, 95% confidence interval = 0.92 to 0.96). This reduction was independent of tumor characteristics, perioperative systemic therapy, baseline body mass index, insulin, and the single nucleotide polymorphism status (all  Ps  >   .11).
Conclusions


Our observation that metformin reduces CA 15-3 by approximately 6% was corroborated in a large placebo-controlled randomized trial. The clinical implications of this reduction in CA 15-3 will be explored in upcoming efficacy analyses of breast cancer outcomes in MA.32.",2021,"<   .001; relative metformin: placebo level of CA 15-3 [adjusted for age, baseline body mass index, and baseline CA 15-3] = 0.94, 95% confidence interval = 0.92 to 0.96).","['Cancer Antigen 15-3/Mucin 1', '3649 patients with T1-3, N0-3, M0 breast cancer', 'CA 15-3 in participants of MA.32, a phase III randomized trial in early-stage breast cancer']","['MA.32', 'metformin', 'Metformin vs Placebo', 'CCTG', 'metformin (vs placebo', 'placebo', 'metformin: placebo', 'CA 15-3 (metformin vs placebo']","['tumor characteristics, perioperative systemic therapy, baseline body mass index, insulin, and the single nucleotide polymorphism status ', 'Mean (SD) baseline']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0006611', 'cui_str': 'Cancer antigen 15-3'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006611', 'cui_str': 'Cancer antigen 15-3'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",3649.0,0.706767,"<   .001; relative metformin: placebo level of CA 15-3 [adjusted for age, baseline body mass index, and baseline CA 15-3] = 0.94, 95% confidence interval = 0.92 to 0.96).","[{'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Goodwin', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, and Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ryan J O', 'Initials': 'RJO', 'LastName': 'Dowling', 'Affiliation': 'Hoffman-La Roche Limited, Mississauga, ON, Canada.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Ennis', 'Affiliation': 'Applied Statistician, Markham, ON, Canada.'}, {'ForeName': 'Bingshu E', 'Initials': 'BE', 'LastName': 'Chen', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Wendy R', 'Initials': 'WR', 'LastName': 'Parulekar', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Lois E', 'Initials': 'LE', 'LastName': 'Shepherd', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Gelmon', 'Affiliation': 'University of British Columbia, BC Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Whelan', 'Affiliation': 'McMaster University, Juravinski Cancer Centre, Hamilton, ON, Canada.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Ligibel', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': 'Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, NY, USA.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Hobday', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'NRG Oncology and University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Rabaglio-Poretti', 'Affiliation': 'IBCSG and Department of Oncology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lemieux', 'Affiliation': 'CHU de Québec-Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Thompson', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Rea', 'Affiliation': 'Cancer Research UK Clinical Trials Unit (CRCTU), Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Vuk', 'Initials': 'V', 'LastName': 'Stambolic', 'Affiliation': 'Department of Medical Biophysics, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada and University of Toronto, Toronto, ON, Canada.'}]",JNCI cancer spectrum,['10.1093/jncics/pkab066']
893,34483325,Subspecialty Fellowship Training is Not Associated with Better Outcomes in Fixation of Low Energy Femoral Neck Fractures - An Analysis of the FAITH Database.,"OBJECTIVES


To compare risk of reoperation for femoral neck fracture patients undergoing fixation with cancellous screws (CS) or sliding hip screws (SHS) based on surgeon fellowship (trauma-fellowship-trained versus non-trauma-fellowship-trained).
DESIGN


Retrospective review of FAITH data.
SETTING


Eighty-one centers across eight countries.
PATIENTS/PARTICIPANTS


819 patients ≥ 50 years-old with low energy hip fractures requiring surgical fixation.
INTERVENTION


Patients were randomized to CS or SHS in the initial dataset.
MAIN OUTCOME MEASUREMENTS


The primary outcome was risk of reoperation. Secondary outcomes included death, serious adverse events, radiographic healing, discharge disposition, and use of ambulatory devices postoperatively.
RESULTS


There was no difference in risk of reoperation between the two surgeon groups (p > 0.05). Patients treated by orthopaedic trauma surgeons were more likely to be overweight/obese and have major medical comorbidities (p < 0.05). There was a higher risk of serious adverse events, higher likelihood of radiographic healing, and higher odds of discharge to a facility for patients treated by trauma-fellowship-trained surgeons (p < 0.05).
CONCLUSIONS


Based on this data, risk of reoperation for low energy femoral neck fracture fixation is equivalent regardless of fellowship training. The higher likelihood of radiographic healing noted in the trauma-trained group does not appear to have a major clinical implication as it did not affect risk of reoperation between the two groups. Patient-specific factors present pre-injury, such as body habitus and medical comorbidities, may account for the lower odds of discharge to home and higher risk of postoperative medical complications for patients treated by orthopaedic trauma surgeons.
LEVEL OF EVIDENCE


Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.",2021,There was no difference in risk of reoperation between the two surgeon groups (p > 0.05).,"['Eighty-one centers across eight countries', 'patients treated by orthopaedic trauma surgeons', 'femoral neck fracture patients undergoing', '819 patients ≥ 50 years-old with low energy hip fractures requiring surgical fixation']","['CS or SHS', 'Subspecialty Fellowship Training', 'fixation with cancellous screws (CS) or sliding hip screws (SHS) based on surgeon fellowship (trauma-fellowship-trained versus non-trauma-fellowship-trained']","['radiographic healing', 'higher risk of serious adverse events', 'risk of reoperation', 'overweight/obese and have major medical comorbidities', 'death, serious adverse events, radiographic healing, discharge disposition, and use of ambulatory devices postoperatively']","[{'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",819.0,0.0744025,There was no difference in risk of reoperation between the two surgeon groups (p > 0.05).,"[{'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'DeAngelis', 'Affiliation': 'Department of Orthopaedic Surgery, University of Pennsylvania, Philadelphia, PA, United States Department of Surgery, University of Western Ontario, London, Ontario, Canada Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada Department of Orthopaedic Surgery, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Stein', 'Affiliation': ''}, {'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Minutillo', 'Affiliation': ''}, {'ForeName': 'Nikhilesh G', 'Initials': 'NG', 'LastName': 'Mehta', 'Affiliation': ''}, {'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': ''}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bzovsky', 'Affiliation': ''}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': ''}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Swiontkowski', 'Affiliation': ''}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Donegan', 'Affiliation': ''}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000002264']
894,34481881,Anodal tDCS accelerates on-line learning of dart throwing.,"Transcranial direct current stimulation (tDCS) has been shown to enhance or block online learning of motor skills, depending on the current direction. However, most research on the use of tDCS has been limited to the study of relatively simple motor tasks. The purpose of the present study was to examine the influence of anodal (a-tDCS) and cathodal (c-tDCS) direct current stimulation on the online learning during a single session of dart throwing. Fifty-eight young adults were randomized to a-tDCS, c-tDCS, or SHAM groups and completed a pre-test block of dart throws, a 20-minute practice block of throws while receiving their stimulation condition, and a post-test block of dart throws. The results showed that a-tDCS accelerated the skill learning of dart throwing more than SHAM and c-tDCS conditions. The SHAM and c-tDCS conditions were not different. We conclude that a-tDCS may have a positive effect in a single training session which would be ideal in a recreational game environment where repeated practice is not common.",2021,The results showed that a-tDCS accelerated the skill learning of dart throwing more than SHAM and c-tDCS conditions.,['Fifty-eight young adults'],"['anodal (a-tDCS) and cathodal (c-tDCS) direct current stimulation', 'tDCS, c-tDCS, or SHAM groups and completed a pre-test block of dart throws, a 20-minute practice block of throws while receiving their stimulation condition, and a post-test block of dart throws', 'Transcranial direct current stimulation (tDCS', 'tDCS']","['Anodal tDCS accelerates on-line learning of dart throwing', 'skill learning']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0336707', 'cui_str': 'Dart'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0336707', 'cui_str': 'Dart'}]",58.0,0.0704114,The results showed that a-tDCS accelerated the skill learning of dart throwing more than SHAM and c-tDCS conditions.,"[{'ForeName': 'Anthony W', 'Initials': 'AW', 'LastName': 'Meek', 'Affiliation': 'School of Health and Human Sciences, Indiana University Purdue University Indianapolis, Indianapolis, IN, USA.'}, {'ForeName': 'Davin', 'Initials': 'D', 'LastName': 'Greenwell', 'Affiliation': 'School of Health and Human Sciences, Indiana University Purdue University Indianapolis, Indianapolis, IN, USA.'}, {'ForeName': 'Brach', 'Initials': 'B', 'LastName': 'Poston', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Riley', 'Affiliation': 'School of Health and Human Sciences, Indiana University Purdue University Indianapolis, Indianapolis, IN, USA. Electronic address: zariley@iu.edu.'}]",Neuroscience letters,['10.1016/j.neulet.2021.136211']
895,34491449,Early failures when using three different adhesively retained core build-up materials-a randomized controlled trial.,"OBJECTIVES


To compare the failure rates for three different adhesively retained core build-up composites up to the incorporation of a permanent fixed dental prosthesis (FDP), and to identify potential failure risk factors.
MATERIAL AND METHODS


A randomized controlled trial of 300 participants in need of a core build-up to restore a vital abutment tooth before prosthetic treatment was conducted. Participants were assigned by stratified block randomization to one of three study groups: Rebilda DC (RDC), Clearfil DC Core (CDC), or Multicore Flow (MF). Test teeth were prepared by use of the respective manufacturer's adhesive system. The total-etch technique was used for RDC and MF, and the self-etch technique for CDC. Participants were treated by dentists (n = 150) or dental students (n = 150). Failure rates of core build-ups before incorporation of FDPs were investigated using univariate and multiple logistic regression.
RESULTS


The overall failure rate was 8% (n = 23). Rate differences between the three investigated groups did not reach statistical significance (p > 0.05). The mean time between placement of core build-ups and placement of fixed dental prostheses was 12.2 (SD: 14.2) weeks. Conversely, larger cavities (> 3 surfaces) and treatment by dental students were independently associated with an increased failure risk (p < 0.05).
CONCLUSIONS


The main risk factors for early failure seem to be the size of the core build-up and clinical experience of the operator, whereas failure rates of core build-up materials combined with a self-etch approach seem to be similar to the rates of materials combined with the total-etch technique.
CLINICAL SIGNIFICANCE


This research article should give clinicians an impression of the short-term performance of different adhesively retained core build-ups using different adhesive techniques/materials. Moreover, predominant influencing factors for the success or failure should be pictured.",2022,This research article should give clinicians an impression of the short-term performance of different adhesively retained core build-ups using different adhesive techniques/materials.,"['300 participants in need of a core build-up to restore a vital abutment tooth before prosthetic treatment was conducted', 'Participants were treated by dentists (n\u2009=\u2009150) or dental students (n\u2009=\u2009150']","['Rebilda DC (RDC), Clearfil DC Core (CDC), or Multicore Flow (MF']","['Failure rates', 'failure rates', 'overall failure rate', 'failure risk', 'mean time between placement of core build-ups and placement of fixed dental prostheses']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}]","[{'cui': 'C2353948', 'cui_str': 'rebilda DC'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C1700605', 'cui_str': 'MultiCore Flow'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}]",300.0,0.235404,This research article should give clinicians an impression of the short-term performance of different adhesively retained core build-ups using different adhesive techniques/materials.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Zenthöfer', 'Affiliation': 'Department of Prosthodontics, Dental School, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. andreas.zenthoefer@med.uni-heidelberg.de.'}, {'ForeName': 'Justo Lorenzo', 'Initials': 'JL', 'LastName': 'Bermejo', 'Affiliation': 'Institute of Medical Biometry, University of Heidelberg, INF 130.3, 69120, Heidelberg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Bömicke', 'Affiliation': 'Department of Prosthodontics, Dental School, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Frese', 'Affiliation': 'Department of Operative Dentistry, Dental School, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Rumeysa', 'Initials': 'R', 'LastName': 'Gülmez', 'Affiliation': 'Department of Prosthodontics, Dental School, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rammelsberg', 'Affiliation': 'Department of Prosthodontics, Dental School, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Ohlmann', 'Affiliation': 'Department of Prosthodontics, Dental School, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}]",Clinical oral investigations,['10.1007/s00784-021-04170-6']
896,34491446,The role of surgical flap design (minimally invasive flap vs. extended flap with papilla preservation) on the healing of intrabony defects treated with an enamel matrix derivative: a 12-month two-center randomized controlled clinical trial.,"OBJECTIVES


Minimally invasive flap designs have been introduced to enhance blood clot stability and support wound healing. Limited data appear to suggest, that in intrabony defects, better clinical outcomes can be achieved by means of minimally invasive flap compared to more extended flaps. The aim of this study was to evaluate the healing of intrabony defects treated with either minimally invasive surgical flaps or with modified or simplified papilla preservation techniques in conjunction with the application of an enamel matrix derivative (EMD).
MATERIALS AND METHODS


Forty-seven subjects were randomly assigned to either test (N = 23) or control (N = 24) procedures. In the test group, the intrabony defects were accessed by means of either minimally invasive surgical technique (MIST) or modified minimally invasive surgical technique (M-MIST) according to the defect localization while the defects in the control group were treated with either the modified or simplified papilla preservation (MPP) or the simplified papilla preservation technique (SPP). EMD was used as regenerative material in all defects. The following clinical parameters were recorded at baseline and after 12 months: full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depths (PD), clinical attachment level (CAL), and gingival recession (GR). Early healing index (EHI) score was assessed in both groups 1 week following the surgery. CAL gain was set as primary outcome.
RESULTS


After 12 months follow-up, the CAL gain was 4.09 ± 1.68 mm in test group and 3.79 ± 1.67 mm in control group, while the PD reduction was 4.52 ± 1.34 mm and 4.04 ± 1.62 mm for test and control sites. In both groups, a minimal GR increase (0.35 ± 1.11 mm and 0.25 ± 1.03 mm) was noted. No residual PDs ≥ 6 mm were recorded in both groups. CAL gains of 4-5 mm were achieved in 30.4% and in 29.2% of test and control group, respectively. Moreover, CAL gains ≥ 6 mm were recorded in 21.7% of experimental sites and in 20.8% of control sites. No statistically significant differences in any of the evaluated parameters were found between the test and control procedures (P > 0.05). After 1 week post-surgery, a statistically significant difference (P < 0.05) between the groups was found in terms of EHI score.
CONCLUSIONS


Within the limits of this pilot RCT, the results have failed to show any differences in the measured parameters following treatment of intrabony defects with EMD, irrespective of the employed surgical technique.
CLINICAL RELEVANCE


In intrabony defects, the application of EMD in conjunction with either MIST/M-MIST or M-PPT/SPPT resulted in substantial clinical improvements.",2022,"After 1 week post-surgery, a statistically significant difference (P < 0.05) between the groups was found in terms of EHI score.
",['Forty-seven subjects'],"['minimally invasive surgical technique (MIST) or modified minimally invasive surgical technique (M-MIST', 'EMD', 'surgical flap design (minimally invasive flap vs. extended flap with papilla preservation', 'minimally invasive surgical flaps or with modified or simplified papilla preservation techniques', 'modified or simplified papilla preservation (MPP) or the simplified papilla preservation technique (SPP', 'enamel matrix derivative']","['CAL gains\u2009≥', 'CAL gains', 'CAL gain', 'residual PDs\u2009≥', 'Early healing index (EHI) score', 'PD reduction', 'full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depths (PD), clinical attachment level (CAL), and gingival recession (GR', 'EHI score']","[{'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}]",47.0,0.0354964,"After 1 week post-surgery, a statistically significant difference (P < 0.05) between the groups was found in terms of EHI score.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Windisch', 'Affiliation': 'Department of Periodontology, Semmelweis University, Szentkiralyi str.47.4th floor, 1088, Budapest, Hungary.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Iorio-Siciliano', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S. Pansini 5 80131, Naples, Italy. enzois@libero.it.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Palkovics', 'Affiliation': 'Department of Periodontology, Semmelweis University, Szentkiralyi str.47.4th floor, 1088, Budapest, Hungary.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Ramaglia', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S. Pansini 5 80131, Naples, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Blasi', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S. Pansini 5 80131, Naples, Italy.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Sculean', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Freiburgstrasse 7, CH-3010, Bern, Switzerland.'}]",Clinical oral investigations,['10.1007/s00784-021-04155-5']
897,34490685,Body representation among adults with phantom limb pain: Results from a foot identification task.,"BACKGROUND


Impaired body representation (i.e. disrupted body awareness or perception) may be a critical, but understudied, factor underlying phantom limb pain (PLP). This cross-sectional study investigated whether adults with lower-limb loss (LLL) and PLP demonstrate impaired body representation as compared to Pain-Free peers with and without LLL.
METHODS


Participants (n = 41 adults with PLP, n = 27 Pain-Free peers with LLL, n = 39 Controls with intact limbs) completed an online foot identification task. Participants judged whether randomized images depicted left or right feet (i.e. left-right discrimination) as quickly as possible without limb movement. Using two Generalized Estimating Equations, effects of group, image characteristics (i.e. side, foot type, view, angle) and trial block (i.e. 1-4) were evaluated, with task response time and accuracy as dependent variables (a ≤ 0.050).
RESULTS


Adults with PLP demonstrated slower and less accurate performance as compared to Controls with intact limbs (p = 0.018) but performed similarly to Pain-Free peers with LLL (p = 0.394). Significant three-way interactions of group, view and angle indicated between-group differences were greatest for dorsal-view images, but smaller and angle-dependent for plantar-view images. While all groups demonstrated significant response time improvements across blocks, improvements were greatest among adults with PLP, who also reported significant reductions in pain intensity.
CONCLUSIONS


Adults with PLP demonstrate body representation impairments as compared to Controls with intact limbs. Body representation impairments, however, may not be unique to PLP, given similar performance between adults with and without PLP following LLL.
SIGNIFICANCE


Following lower-limb loss, adults with phantom limb pain (PLP) demonstrate impaired body representation as compared to Controls with intact limbs, evidenced by slower response times and reduced accuracy when completing a task requiring mental rotation. Importantly, 80% of participants with pre-task PLP reported reduced pain intensity during the task, providing compelling evidence for future investigations into whether imagery-based, mind-body interventions have positive effects on PLP.",2022,"RESULTS


Adults with phantom limb pain demonstrated slower and less accurate performance as compared to controls with intact limbs (p=.018) but performed similarly to pain-free peers with lower-limb loss (p=.394).","['Participants (n=41 adults with phantom limb pain, n=27 pain-free peers with lower-limb loss, n=39 controls with intact limbs', 'adults with lower-limb loss and phantom limb pain demonstrate impaired body representation as compared to pain-free peers with and without lower-limb loss', 'Adults with Phantom Limb Pain']",['online foot identification task'],"['accurate performance', 'pain intensity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0031315', 'cui_str': 'Phantom limb'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C3489573', 'cui_str': 'Body Representation'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",41.0,0.0203922,"RESULTS


Adults with phantom limb pain demonstrated slower and less accurate performance as compared to controls with intact limbs (p=.018) but performed similarly to pain-free peers with lower-limb loss (p=.394).","[{'ForeName': 'Emma H', 'Initials': 'EH', 'LastName': 'Beisheim-Ryan', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Pohlig', 'Affiliation': 'Biostatistics Core, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Medina', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Hicks', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Jaclyn M', 'Initials': 'JM', 'LastName': 'Sions', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, Delaware, USA.'}]","European journal of pain (London, England)",['10.1002/ejp.1860']
898,34510395,Does the association of therapeutic exercise and supplementation with sucrosomial magnesium improve posture and balance and prevent the risk of new falls?,"BACKGROUND


Fracture of the proximal femur is the most feared complication of osteoporosis. Given the numerous physiological functions that magnesium performs in our body, in the literature there is a correlation between osteoporosis and low serum levels of magnesium.
AIM


Evaluate the incidence of hypomagnesemia in patients with lateral fragility fracture of the proximal femur, the possible correlation between serum magnesium levels and fractures, and the effectiveness of supplementing Sucrosomial ®  magnesium associated with therapeutic exercise on the outcome of these patients.
METHODS


We divided the study into two parts. In the first part, we assessed the preoperative incidence of hypomagnesemia in patients using a blood test. In the second part, patients with hypomagnesemia were divided, in the post-operative period, into two groups, who received, respectively, only therapeutic exercise or oral supplementation with sucrosomial magnesium associated with therapeutic exercise.
RESULTS


Half of the patients with fragility femoral fracture had hypomagnesemia, with a higher incidence of the subclinical form. From the comparison between the two groups, the T1 treatment group showed a significant improvement in blood levels of magnesium (2.11 ± 0.15 vs. 1.94 ± 0.11; p < 0.05), on the NRS scale (5.7 ± 0.81 vs. 6.6 ± 1.18; p < 0.05), the Tinetti scale (17.3 ± 1.15 vs. 15.2 ± 2.98; p < 0.05) and the SarQoL questionnaire (47.3 ± 5.21 vs. 44.9 ± 5.54; p < 0.05).
CONCLUSIONS


More attention would be needed in the diagnosis and correction of subclinical hypomagnesemia and not just the simple and clinically evident one, including hypomagnesemia among the modifiable risk factors for osteoporosis.",2022,"From the comparison between the two groups, the T1 treatment group showed a significant improvement in blood levels of magnesium (2.11 ± 0.15 vs. 1.94 ± 0.11; p < 0.05), on the NRS scale (5.7 ± 0.81 vs. 6.6 ± 1.18; p < 0.05), the Tinetti scale (17.3 ± 1.15 vs. 15.2 ± 2.98; p < 0.05) and the SarQoL questionnaire (47.3 ± 5.21 vs. 44.9 ± 5.54; p < 0.05).
","['patients with lateral fragility fracture of the proximal femur', 'patients with hypomagnesemia']","['sucrosomial magnesium', 'therapeutic exercise or oral supplementation with sucrosomial magnesium associated with therapeutic exercise']","['SarQoL questionnaire', 'preoperative incidence of hypomagnesemia', 'NRS scale', 'hypomagnesemia', 'blood levels of magnesium', 'Tinetti scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}]",,0.0308142,"From the comparison between the two groups, the T1 treatment group showed a significant improvement in blood levels of magnesium (2.11 ± 0.15 vs. 1.94 ± 0.11; p < 0.05), on the NRS scale (5.7 ± 0.81 vs. 6.6 ± 1.18; p < 0.05), the Tinetti scale (17.3 ± 1.15 vs. 15.2 ± 2.98; p < 0.05) and the SarQoL questionnaire (47.3 ± 5.21 vs. 44.9 ± 5.54; p < 0.05).
","[{'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Scaturro', 'Affiliation': 'Department of Surgical, Oncological and Stomatological Disciplines, University of Palermo, Via del Vespro, 129, 90127, Palermo, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Vitagliani', 'Affiliation': 'Department of Surgical, Oncological and Stomatological Disciplines, University of Palermo, Via del Vespro, 129, 90127, Palermo, Italy. fabiovitagliani93@libero.it.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Terrana', 'Affiliation': 'Department of Surgical, Oncological and Stomatological Disciplines, University of Palermo, Via del Vespro, 129, 90127, Palermo, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Tomasello', 'Affiliation': 'University of Verona, Verona, Italy.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Camarda', 'Affiliation': 'Department of Surgical, Oncological and Stomatological Disciplines, University of Palermo, Via del Vespro, 129, 90127, Palermo, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Letizia Mauro', 'Affiliation': 'Department of Surgical, Oncological and Stomatological Disciplines, University of Palermo, Via del Vespro, 129, 90127, Palermo, Italy.'}]",Aging clinical and experimental research,['10.1007/s40520-021-01977-x']
899,34498421,Aspiration pneumonia in head and neck cancer patients undergoing concurrent chemoradiation from India: Findings from a post hoc analysis of a phase 3 study.,"BACKGROUND


There are limited data from low- to middle-income countries (LMIC) on the incidence, risk factors, treatment outcomes, and antibiotic susceptibility spectrum of aspiration pneumonia (AsP).
METHODS


We conducted a post hoc analysis of a randomized control trial in which adult patients with locally advanced head and neck cancers had received 66-70 Gy of radiation combined with cisplatin 30 mg/m 2  weekly for 6-7 weeks or cisplatin at the same dose with nimotuzumab 200 mg once weekly till the completion of radiation. The following data were extracted and analyzed-the incidence of AsP, time to the onset of AsP, risk factors, treatment outcomes of AsP, and its impact on progression-free survival (PFS), locoregional control (LRC) rates, and overall survival (OS).
RESULTS


Out of 536 patients enrolled in the study, 151 (28.3%, 95% confidence interval [CI] 24.5-2.1) patients developed AsP. The median time to develop AsP was 39 days (95% CI 34-44). Only baseline dysphagia (odds ratio = 3.76, 95% CI 1.05-13.51, p = 0.042) was associated with a significant risk of development of AsP. Among the patients in which pathogenic organism was isolated (69 patients), gram-negative species was isolated in 63 patients (89%). Cisplatin at 200 mg/m 2  or more was delivered in 312 (81%) patients in the non-AsP cohort versus 107 (70.9%) patients in AsP cohort (p = 0.014). There was no statistical difference in LRC (hazard ratio [HR] = 1.057; 95% CI 0.771-1.448), PFS (HR = 1.176; 95% CI 0.89-1.553), and OS (HR = 1.233; 95% CI 0.939-1.618) between the two cohorts.
CONCLUSION


Aspiration pneumonia is a common complication in head and neck malignancies and patients with baseline dysphagia are at high risk. Gram-negative bacteria are the predominant causative agents. The use of broad-spectrum antibiotics results in resolution of symptoms.",2021,"Only baseline dysphagia (odds ratio = 3.76, 95% CI 1.05-13.51, p = 0.042) was associated with a significant risk of development of AsP.","['head and neck cancer patients undergoing concurrent chemoradiation from India', '536 patients enrolled in the study, 151 ', 'adult patients with locally advanced head and neck cancers']","['66-70\xa0Gy of radiation combined with cisplatin 30', 'cisplatin', 'Cisplatin', 'nimotuzumab 200\xa0mg once weekly till the completion of radiation']","['progression-free survival (PFS), locoregional control (LRC) rates, and overall survival (OS', 'baseline dysphagia', 'LRC', 'PFS', 'median time to develop AsP', 'risk of development of AsP']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1570308', 'cui_str': 'Nimotuzumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004015', 'cui_str': 'Aspartic Acid'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",536.0,0.25168,"Only baseline dysphagia (odds ratio = 3.76, 95% CI 1.05-13.51, p = 0.042) was associated with a significant risk of development of AsP.","[{'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Patil', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, HBNI, Mumbai, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Noronha', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, HBNI, Mumbai, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Shrirangwar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, HBNI, Mumbai, India.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Menon', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, HBNI, Mumbai, India.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Abraham', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, HBNI, Mumbai, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Chandrasekharan', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, HBNI, Mumbai, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, HBNI, Mumbai, India.'}]",Cancer medicine,['10.1002/cam4.4210']
900,34498388,The bioequivalence of fixed-dose combination tablets of bisoprolol and ramipril and its drug-drug interaction potential.,"Chronic antihypertensive treatment often includes combination of two or more therapies with complementary mechanism of action targeting different blood pressure (BP) control system. If available, these components are recommended to be administered as a fixed-dose combination (FDC) to reduce tablet burden, improve adherence and thus BP control. A combination of ramipril (RAMI) and bisoprolol (BISO) is one of the options used in clinical practice and is supported by therapeutic guidelines. The clinical program for a novel BISO/RAMI FDC consisted of two randomized, open-label, bioequivalence (BE) studies and one drug-drug interaction (DDI) study. The BE was examined between two FDC strengths of BISO/RAMI (10/10 and 10/5 mg) and the individual reference products administered concomitantly at respective doses after a single oral dose under fasting conditions. In both BE studies, 64 healthy subjects were randomized according to a two-way crossover design. The DDI study evaluated a potential pharmacokinetic (PK) interaction between BISO 10 mg and RAMI 10 mg following their single or concomitant administrations in 30 healthy subjects under fasting condition. BE for BISO/RAMI 10/5 mg and absence of a clinically relevant PK DDI between BISO and RAMI was demonstrated as the 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) for area under the concentration time curve (AUC) and maximum concentration (C max  ) remained within the acceptance range of 80.00 to 125.00%. However, BE for BISO/RAMI 10/10 mg was not demonstrated, as the lower bound of the 90% CI of C max  for RAMI was outside the acceptance range of BE. Both drugs administered alone or combined were well-tolerated. No PK interaction was observed between BISO and RAMI/ramiprilat, since the co-administration of BISO and RAMI 10 mg single doses resulted in comparable rate and extent of absorption for BISO and RAMI when compared to their individual products.",2022,Both drugs administered alone or combined were well-tolerated.,"['64 healthy subjects', '30 healthy subjects under fasting condition']","['ramipril (RAMI) and bisoprolol (BISO', 'RAMI', 'bisoprolol and ramipril']","['rate and extent of absorption for BISO and RAMI', 'potential pharmacokinetic (PK) interaction', 'geometric mean ratios (GMRs) for area under the concentration time curve (AUC) and maximum concentration (C max  ', 'blood pressure (BP) control system']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}]","[{'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C1868980', 'cui_str': 'Pharmacokinetic interaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",30.0,0.0460497,Both drugs administered alone or combined were well-tolerated.,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Sus', 'Affiliation': 'Zentiva, k.s., Prague, Czech Republic.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Huguet', 'Affiliation': 'Altasciences, Laval, Quebec, Canada.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bosak', 'Affiliation': 'Zentiva, k.s., Prague, Czech Republic.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Setnik', 'Affiliation': 'Altasciences, Laval, Quebec, Canada.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Hauser', 'Affiliation': 'Zentiva, k.s., Prague, Czech Republic.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Sicard', 'Affiliation': 'Altasciences, Laval, Quebec, Canada.'}]",Clinical and translational science,['10.1111/cts.13128']
901,34500117,Liver fibrosis staging by computed tomography: Prospective randomized multicentric evaluation of image analyses.,"AIM


Liver fibrosis staging is essential. We prospectively evaluated the liver fibrosis staging performance of computed tomography (CT).
METHODS


70 hepato-gastroenterology clinicians were randomized into three stratified groups with different image analyses of radiological semiology, i.e., on raw images (group 1) and on expert-annotated (group 2) and computerized-morphometry-enriched (group 3) images. Radiological fibrosis staging based on seven simple descriptors into four stages equivalent to Metavir stages (F0/1, F2, F3, F4=cirrhosis) was determined at baseline and after image analyses in 10 patients with chronic liver diseases (two per F) concordant for four independent fibrosis stagings including Metavir. 23,800 CT images were analysed, providing 1400 fibrosis stagings.
RESULTS


Fibrosis staging: overall (3 groups) accuracy (correct classification rate) was, baseline: 43%, post-analysis: 60% (p < 0.001) without significant progression in group 1 (6%, p = 0.207) contrary to groups 2 (34%, p < 0.001) and 3 (13%, p = 0.007). Cirrhosis diagnosis: overall accuracy was, baseline: 84%, post-analysis: 89% (p < 0.001) without significant progression in group 1 (0%, p = 1) contrary to groups 2 (8%, p = 0.009) and 3 (7%, p = 0.015). Baseline AUROCs were good (≥0.83) for marked fibrosis (F≥3 or cirrhosis) in all groups. Post-analysis AUROCs became excellent (≥0.89) in group 2 for all diagnostic targets (≥0.98 for F≥3 and cirrhosis) and in group 3 for cirrhosis. In post-analysis group 2, discrimination between all F was excellent (especially, F1 from F0) with an Obuchowski index at 0.87. Negative and positive predictive values for marked fibrosis were 98% and 95%, respectively.
CONCLUSION


Simple CT descriptors accurately discriminate all Metavir liver fibrosis stages.",2022,Baseline AUROCs were good (≥0.83) for marked fibrosis (F≥3 or cirrhosis) in all groups.,"['10 patients with chronic liver diseases (two per F) concordant for four independent fibrosis stagings including Metavir', '70 hepato-gastroenterology clinicians']",['computed tomography (CT'],['marked fibrosis (F≥3 or cirrhosis'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]",23800.0,0.104651,Baseline AUROCs were good (≥0.83) for marked fibrosis (F≥3 or cirrhosis) in all groups.,"[{'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Vitellius', 'Affiliation': 'Hepato-gastroenterology department, Angers University Hospital, Angers, France; HIFIH Laboratory UPRES EA3859, SFR 4208, Angers University, Angers, France.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Paisant', 'Affiliation': 'HIFIH Laboratory UPRES EA3859, SFR 4208, Angers University, Angers, France; Radiology department, Angers University Hospital, Angers, France.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Lannes', 'Affiliation': 'Hepato-gastroenterology department, Angers University Hospital, Angers, France; HIFIH Laboratory UPRES EA3859, SFR 4208, Angers University, Angers, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Chaigneau', 'Affiliation': 'HIFIH Laboratory UPRES EA3859, SFR 4208, Angers University, Angers, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Oberti', 'Affiliation': 'Hepato-gastroenterology department, Angers University Hospital, Angers, France; HIFIH Laboratory UPRES EA3859, SFR 4208, Angers University, Angers, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Lebigot', 'Affiliation': 'HIFIH Laboratory UPRES EA3859, SFR 4208, Angers University, Angers, France; Radiology department, Angers University Hospital, Angers, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Fouchard', 'Affiliation': 'Hepato-gastroenterology department, Angers University Hospital, Angers, France; HIFIH Laboratory UPRES EA3859, SFR 4208, Angers University, Angers, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Boursier', 'Affiliation': 'Hepato-gastroenterology department, Angers University Hospital, Angers, France; HIFIH Laboratory UPRES EA3859, SFR 4208, Angers University, Angers, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'David', 'Affiliation': 'Radiology centre, 24 Couscher street, 49400 Saumur, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Aubé', 'Affiliation': 'HIFIH Laboratory UPRES EA3859, SFR 4208, Angers University, Angers, France; Radiology department, Angers University Hospital, Angers, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Calès', 'Affiliation': 'Hepato-gastroenterology department, Angers University Hospital, Angers, France; HIFIH Laboratory UPRES EA3859, SFR 4208, Angers University, Angers, France. Electronic address: paul.cales@univ-angers.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2021.101797']
902,34495879,Association of Socioeconomic Status With Postdischarge Pediatric Resource Use and Quality of Life.,"OBJECTIVES


Socioeconomic factors may impact healthcare resource use and health-related quality of life, but their association with postcritical illness outcomes is unknown. This study examines the associations between socioeconomic status, resource use, and health-related quality of life in a cohort of children recovering from acute respiratory failure.
DESIGN


Secondary analysis of data from the Randomized Evaluation of Sedation Titration for Respiratory Failure clinical trial.
SETTING


Thirty-one PICUs.
PATIENTS


Children with acute respiratory failure enrolled whose parent/guardians consented for follow-up.
MEASUREMENTS AND MAIN RESULTS


Resource use included in-home care, number of healthcare providers, prescribed medications, home medical equipment, emergency department visits, and hospital readmission. Socioeconomic status was estimated by matching residential address to census tract-based median income. Health-related quality of life was measured using age-based parent-report instruments. Resource use interviews with matched census tract data (n = 958) and health-related quality of life questionnaires (n = 750/958) were assessed. Compared with high-income children, low-income children received care from fewer types of healthcare providers (β = -0.4; p = 0.004), used less newly prescribed medical equipment (odds ratio = 0.4; p < 0.001), and had more emergency department visits (43% vs 33%; p = 0.04). In the youngest cohort (< 2 yr old), low-income children had lower quality of life scores from physical ability (-8.6 points; p = 0.01) and bodily pain/discomfort (+8.2 points; p < 0.05). In addition, health-related quality of life was lower in those who had more healthcare providers and prescribed medications. In older children, health-related quality of life was lower if they had prescribed medications, emergency department visits, or hospital readmission.
CONCLUSIONS


Children recovering from acute respiratory failure have ongoing healthcare resource use. Yet, lower income children use less in-home and outpatient services and use more hospital resources. Continued follow-up care, especially in lower income children, may help identify those in need of ongoing healthcare resources and those at-risk for decreased health-related quality of life.",2022,"In older children, health-related quality of life was lower if they had prescribed medications, emergency department visits, or hospital readmission.
","['Children with acute respiratory failure enrolled whose parent/guardians consented for follow-up', 'children recovering from acute respiratory failure', 'Thirty-one PICUs']",['Sedation Titration'],"['Socioeconomic Status', 'emergency department visits', 'Socioeconomic status', 'quality of life scores from physical ability', 'health-related quality of life', 'bodily pain/discomfort', 'Resource use included in-home care, number of healthcare providers, prescribed medications, home medical equipment, emergency department visits, and hospital readmission', 'health-related quality of life questionnaires', 'Quality of Life', 'Health-related quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C1046445', 'cui_str': 'Picus'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}]","[{'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",958.0,0.0647501,"In older children, health-related quality of life was lower if they had prescribed medications, emergency department visits, or hospital readmission.
","[{'ForeName': 'Alicia G', 'Initials': 'AG', 'LastName': 'Kachmar', 'Affiliation': 'Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Watson', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, WA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wypij', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Mallory A', 'Initials': 'MA', 'LastName': 'Perry', 'Affiliation': ""Department of Critical Care and Anesthesia, The Children's Hospital of Philadelphia Research Institute, Philadelphia, PA.""}, {'ForeName': 'Martha A Q', 'Initials': 'MAQ', 'LastName': 'Curley', 'Affiliation': 'Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000005261']
903,34504990,Genomic Profiling of Premenopausal HR+ and HER2- Metastatic Breast Cancer by Circulating Tumor DNA and Association of Genetic Alterations With Therapeutic Response to Endocrine Therapy and Ribociclib.,"PURPOSE


This analysis evaluated the genomic landscape of premenopausal patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer and the association of genetic alterations with response to ribociclib in the phase III MONALEESA-7 trial.
METHODS


Premenopausal patients were randomly assigned 1:1 to receive endocrine therapy plus ribociclib or placebo. Plasma collected at baseline was sequenced using targeted next-generation sequencing for approximately 600 relevant cancer genes. The association of circulating tumor DNA alterations with progression-free survival (PFS) was evaluated to identify biomarkers of response and resistance to ribociclib.
RESULTS


Baseline circulating tumor DNA was sequenced in 565 patients; 489 had evidence of ≥ 1 alteration. The most frequent alterations included  PIK3CA  (28%),  TP53  (19%),  CCND1  (10%),  MYC  (8%),  GATA3  (8%), receptor tyrosine kinases (17%), and the Chr8p11.23 locus (12%). A treatment benefit of ribociclib was seen with wild-type (hazard ratio [HR] 0.45 [95% CI, 0.33 to 0.62]) and altered (HR 0.57 [95% CI, 0.36 to 0.9])  PIK3CA . Overall, patients with altered  CCND1  had shorter PFS regardless of treatment, suggesting  CCND1  as a potential prognostic biomarker. Benefit with ribociclib was seen in patients with altered (HR 0.21 [95% CI, 0.08 to 0.54]) or wild-type (HR 0.52 [95% CI, 0.39 to 0.68])  CCND1 , but greater benefit was observed with altered, suggesting predictive potential of  CCND1 . Alterations in  TP53 ,  MYC , Chr8p11.23 locus, and receptor tyrosine kinases were associated with worse PFS, but ribociclib benefit was independent of alteration status.
CONCLUSION


In this study-to our knowledge, the first large study of premenopausal patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer-multiple genomic alterations were associated with poor outcome. A PFS benefit of ribociclib was observed regardless of gene alteration status, although in this exploratory analysis, a magnitude of benefits varied by alteration.",2021,"Alterations in  TP53 ,  MYC , Chr8p11.23 locus, and receptor tyrosine kinases were associated with worse PFS, but ribociclib benefit was independent of alteration status.
","['565 patients; 489 had evidence of ≥ 1 alteration', 'premenopausal patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer', 'premenopausal patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer-multiple genomic alterations', 'Premenopausal patients']",['endocrine therapy plus ribociclib or placebo'],"['receptor tyrosine kinases', 'TP53']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0017428', 'cui_str': 'Genome'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0206364', 'cui_str': 'Receptor Protein-Tyrosine Kinase'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}]",600.0,0.178522,"Alterations in  TP53 ,  MYC , Chr8p11.23 locus, and receptor tyrosine kinases were associated with worse PFS, but ribociclib benefit was independent of alteration status.
","[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Bardia', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Su', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Solovieff', 'Affiliation': 'Novartis Pharmaceuticals Corporation, Cambridge, MA.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei Cancer Center, Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Keun Seok', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Center for Breast Cancer, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Campos-Gomez', 'Affiliation': 'Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Division of Medical Senology, IEO, European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'Rafael Villanueva', 'Initials': 'RV', 'LastName': 'Vázquez', 'Affiliation': ""Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Franke', 'Affiliation': 'Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hurvitz', 'Affiliation': 'University of California, Los Angeles Jonsson Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Department of Obstetrics and Gynecology, Breast Center, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Chow', 'Affiliation': 'Organisation for Oncology and Translational Research, Hong Kong, China.'}, {'ForeName': 'Tetiana', 'Initials': 'T', 'LastName': 'Taran', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rodriguez Lorenc', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Babbar', 'Affiliation': 'Novartis Pharmaceuticals Corporation, Cambridge, MA.'}, {'ForeName': 'Debu', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Yen-Shen', 'Initials': 'YS', 'LastName': 'Lu', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}]",JCO precision oncology,['10.1200/PO.20.00445']
904,34508021,The Effect of Computer-Based Training on Self-care and Daily Living Activities in Patients With Lumbar Discectomy Surgery: A Randomized Controlled Study.,"This research was conducted to determine the effect of computer-based discharge training on patients with lumbar disc surgery on self-care agency and independence in daily living activities. A randomized controlled study was conducted on 60 patients, 30 in the intervention group and 30 in the control group. Computer-based lumbar disc surgery discharge training and a CD containing the training content were given to the intervention group after the surgery, whereas the control group received routine discharge training in the ward. The data of the study were collected using a Patient Information Form, the modified Barthel Index, and the Exercise of Self-Care Agency Scale. The increase in the modified Barthel Index and Exercise of Self-Care Agency Scale scores after training in the intervention and control groups were statistically significant (P < .001). The increase in Exercise of Self-Care Agency Scale scores after the training was found to be higher in the intervention group than in the control group. There was no difference between the modified Barthel Index mean scores before and after the training between the groups (P > .05). Computer-based discharge training improved the participants' independence in their daily living activities and increased the self-care power of the patients compared with the control group.",2021,The increase in Exercise of Self-Care Agency Scale scores after the training was found to be higher in the intervention group than in the control group.,"['patients with lumbar disc surgery on self-care agency and independence in daily living activities', '60 patients, 30 in the intervention group and 30 in the control group', 'Patients With Lumbar Discectomy Surgery']","['Computer-based lumbar disc surgery discharge training', 'routine discharge training', 'Computer-Based Training', 'computer-based discharge training', 'Computer-based discharge training']","['modified Barthel Index and Exercise of Self-Care Agency Scale scores', 'modified Barthel Index mean scores', 'Self-care and Daily Living Activities', 'Exercise of Self-Care Agency Scale scores', 'self-care power']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",60.0,0.00526145,The increase in Exercise of Self-Care Agency Scale scores after the training was found to be higher in the intervention group than in the control group.,"[{'ForeName': 'Busra Selma', 'Initials': 'BS', 'LastName': 'Saha', 'Affiliation': 'Author Affiliation: Hamidiye Faculty of Nursing, Department of Surgical Nursing, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Sonay', 'Initials': 'S', 'LastName': 'Goktas', 'Affiliation': ''}]","Computers, informatics, nursing : CIN",['10.1097/CIN.0000000000000829']
905,34498370,A cluster-randomized controlled trial to improve the quality of integrated HIV-tuberculosis services in primary healthcareclinics in South Africa.,"INTRODUCTION


Tuberculosis (TB) remains the most common cause of death among people living with HIV. Integrating HIV and TB services reduces mortality but is sub-optimally implemented. Quality improvement (QI) methods offer a low-cost and easily implementable approach to strengthening healthcare delivery systems. This trial assessed a QI intervention on key process indicators for delivering integrated HIV-TB care in rural South African primary healthcare (PHC) clinics.
METHODS


Sixteen nurse supervisors, (each with a cluster of clinics) overseeing 40 PHC clinics, were randomized 1:1 to the intervention or the standard of care (SOC) groups. The QI intervention comprised three key components: clinical and QI skills training, on-site mentorship of nurse supervisors and clinic staff, and data quality improvement activities to enhance accuracy and completeness of routine clinic data. The SOC comprised monthly supervision and data feedback meetings. From 01 December 2016 to 31 December 2018, data were collected monthly by a team of study-appointed data capturers from all study clinics. This study's outcomes were HIV testing services (HTS), TB screening, antiretroviral therapy (ART) initiation, isoniazid preventive therapy (IPT) initiation and viral load (VL) testing.
RESULTS


The QI group (eight clusters) comprised 244 clinic staff who attended to 13,347 patients during the trial compared to the SOC group (eight clusters) with 217 clinic staff who attended to 8141 patients. QI mentors completed 85% (510/600) of expected QI mentorship visits to QI clinics. HTS was 19% higher [94.5% vs. 79.6%; relative risk (RR)=1.19; 95% CI: 1.02-1.38; p=0.029] and IPT initiation was 66% higher (61.2 vs. 36.8; RR=1.66; 95% CI: 1.02-2.72; p=0·044), in the QI group compared to SOC group. The percentage of patients screened for TB (83.4% vs. 79.3%; RR=1.05; p=0.448), initiated on ART (91.7 vs. 95.5; RR=0.96; p=0.172) and VL testing (72.2% vs. 72.8%; RR=0.99; p=0.879) was similar in both groups.
CONCLUSIONS


QI improved HIV testing and IPT initiation compared to SOC. TB screening, ART initiation and VL testing remained similar. Incorporating QI methods into routine supervision and support activities may strengthen integrated HIV-TB service delivery and increase the success of future QI scale-up activities.",2021,"HTS was 19% higher [94.5% vs. 79.6%; relative risk (RR)=1.19; 95% CI: 1.02-1.38; p=0.029] and IPT initiation was 66% higher (61.2 vs. 36.8; RR=1.66; 95% CI: 1.02-2.72; p=0·044), in the QI group compared to SOC group.","['244 clinic staff who attended to 13,347 patients during the trial compared to the SOC group (eight clusters) with 217 clinic staff who attended to 8141 patients', 'From 01 December 2016 to 31 December 2018, data were collected monthly by a team of study-appointed data capturers from all study clinics', 'primary healthcareclinics in South Africa', 'Sixteen nurse supervisors, (each with a cluster of clinics) overseeing 40 PHC clinics', 'people living with HIV', 'rural South African primary healthcare (PHC) clinics']",['QI intervention'],"['IPT initiation', 'HIV testing services (HTS), TB screening, antiretroviral therapy (ART) initiation, isoniazid preventive therapy (IPT) initiation and viral load (VL) testing', 'HTS', 'HIV testing and IPT initiation']","[{'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027567', 'cui_str': 'African race'}]","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0420004', 'cui_str': 'Tuberculosis screening'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",,0.286717,"HTS was 19% higher [94.5% vs. 79.6%; relative risk (RR)=1.19; 95% CI: 1.02-1.38; p=0.029] and IPT initiation was 66% higher (61.2 vs. 36.8; RR=1.66; 95% CI: 1.02-2.72; p=0·044), in the QI group compared to SOC group.","[{'ForeName': 'Santhanalakshmi', 'Initials': 'S', 'LastName': 'Gengiah', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Pierre M', 'Initials': 'PM', 'LastName': 'Barker', 'Affiliation': 'Institute for Healthcare Improvement, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Nonhlanhla', 'Initials': 'N', 'LastName': 'Yende-Zuma', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Mduduzi', 'Initials': 'M', 'LastName': 'Mbatha', 'Affiliation': 'Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Naidoo', 'Affiliation': 'Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Loveday', 'Affiliation': 'MRC-CAPRISA HIV-TB Pathogenesis and Treatment Research Unit, Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Mesuli', 'Initials': 'M', 'LastName': 'Mhlongo', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Clark', 'Initials': 'C', 'LastName': 'Jackson', 'Affiliation': 'Institute for Healthcare Improvement, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Nunn', 'Affiliation': 'Medical Research Council, Clinical Trials Unit at University College London (UCL), London, UK.'}, {'ForeName': 'Nesri', 'Initials': 'N', 'LastName': 'Padayatchi', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Salim S Abdool', 'Initials': 'SSA', 'LastName': 'Karim', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Kogieleum', 'Initials': 'K', 'LastName': 'Naidoo', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}]",Journal of the International AIDS Society,['10.1002/jia2.25803']
906,34523146,Depressive symptoms interfere with the improvement in exercise capacity by cardiac rehabilitation after left ventricular assist device implantation.,"BACKGROUND


Although depressive symptoms are associated with an increased risk of readmission after left ventricular assist device (LVAD) implantation, it is unclear whether they affect the efficacy of exercise-based cardiac rehabilitation (EBCR). This study aimed to investigate the effect of depressive symptoms on EBCR efficacy.
METHODS


We analyzed 48 patients who participated in EBCR after LVAD implantation (mean age 45 ± 12 years; 60% male). Patients were classified into two groups using the Zung Self-Rating Depression Scale (SDS): depressive group (SDS ≥40, n = 27) and non-depressive group (SDS <40, n = 21). We examined changes in peak oxygen uptake (VO 2  ), knee extensor muscular strength (KEMS), and quality of life (QOL) during EBCR using analysis of covariance.
RESULTS


Although baseline characteristics were similar between the two groups, the non-depressive group was less likely to receive diuretics (22% vs. 52%, p = 0.030). Peak VO 2  , KEMS, and QOL significantly increased over time in both groups (all p < 0.05). The depressive group had a significantly lower change in peak VO 2  than the non-depressive group (2.7 vs. 1.6 ml/kg/min; mean difference: -1.1 ml/kg/min, 95% confidence interval [CI]: -0.045 to -2.17; p = 0.041, d = 0.59). There was no between-group difference regarding the change in KEMS or QOL. Adjusting for the baseline value, a significant difference between groups was observed only in peak VO 2  (p = 0.045).
CONCLUSIONS


Although EBCR significantly improved exercise capacity after LVAD implantation, depressive symptoms interfered with this improvement. Further studies are needed to determine whether psychological interventions for depression, in addition to EBCR, would improve the response to EBCR after LVAD implantation.",2022,"Peak VO 2  , KEMS, and QOL significantly increased over time in both groups (all p<0.05).","['SDS): depressive group (SDS≥40, n=27) and non-depressive group (SDS<40, n=21', '48 patients who participated in EBCR after LVAD implantation (mean age 45±12 years; 60% male']",['EBCR'],"['depressive symptoms', 'Zung Self-Rating Depression Scale', 'Peak VO 2  , KEMS, and QOL', 'peak oxygen uptake (VO 2  ), knee extensor muscular strength (KEMS), and quality of life (QOL', 'peak VO', 'KEMS or QOL', 'exercise capacity']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451593', 'cui_str': 'Zung self-rating depression scale'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",48.0,0.091942,"Peak VO 2  , KEMS, and QOL significantly increased over time in both groups (all p<0.05).","[{'ForeName': 'Kazufumi', 'Initials': 'K', 'LastName': 'Kitagaki', 'Affiliation': 'Faculty of Rehabilitation, Shijonawate Gakuen University, Osaka, Japan.'}, {'ForeName': 'Rei', 'Initials': 'R', 'LastName': 'Ono', 'Affiliation': 'Department of Public Health, Kobe University Graduate School of Health Sciences, Kobe, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': 'Department of Cardiovascular Rehabilitation, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Yanagi', 'Affiliation': 'Department of Cardiovascular Rehabilitation, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Harumi', 'Initials': 'H', 'LastName': 'Konishi', 'Affiliation': 'Department of Nursing, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Nakanishi', 'Affiliation': 'Department of Cardiovascular Rehabilitation, National Cerebral and Cardiovascular Center, Osaka, Japan.'}]",Artificial organs,['10.1111/aor.14072']
907,34489756,The LIFEwithIBD Intervention: Study Protocol for a Randomized Controlled Trial of a Face-to-Face Acceptance and Commitment Therapy and Compassion-Based Intervention Tailored to People With Inflammatory Bowel Disease.,"Background:  There is ample evidence of the high mental health burden caused by Inflammatory Bowel Disease (IBD). Several constructs such as experiential avoidance, cognitive fusion, shame, and self-criticism have recently emerged as potential intervention targets to improve mental health in IBD. Psychotherapeutic models such as Acceptance and Commitment Therapy and compassion-based interventions are known to target these constructs. In this protocol, we aim to describe a two-arm Randomized Controlled Trial (RCT) testing the efficacy of an ACT and compassion-focused intervention named Living with Intention, Fullness, and Engagement with Inflammatory Bowel Disease (LIFEwithIBD) intervention + Treatment As Usual (TAU) vs. TAU in improving psychological distress, quality of life, work and social functioning, IBD symptom perception, illness-related shame, psychological flexibility, self-compassion, disease activity, inflammation biomarkers, and gut microbiota diversity.  Methods:  This trial is registered at ClinicalTrials.gov (Identifier: NCT03840707, date assigned 13/02/2019). The LIFEwithIBD intervention is an adaptation to the IBD population of the Mind programme for people with cancer, an acceptance, mindfulness, and compassion-based intervention designed to be delivered in a group format. The LIFEwithIBD intervention's structure and topics are presented in this protocol. Participants were recruited at the Gastroenterology Service of the Coimbra University Hospital between June and September 2019. Of the 355 patients screened, 61 participants were selected, randomly assigned to one of two conditions [experimental group (LIFEwithIBD + TAU) or control group (TAU)] and completed the baseline assessment. Outcome measurement took place at baseline, post-intervention, 3- and 12-month follow-ups.  Discussion:  Results from this RCT will support future studies testing the LIFEwithIBD intervention or other acceptance and/or compassion-based interventions for IBD.",2021,"The LIFEwithIBD intervention is an adaptation to the IBD population of the Mind programme for people with cancer, an acceptance, mindfulness, and compassion-based intervention designed to be delivered in a group format.","['355 patients screened, 61 participants', 'People With Inflammatory Bowel Disease', 'Participants were recruited at the Gastroenterology Service of the Coimbra University Hospital between June and September 2019']","['LIFEwithIBD intervention', 'Face-to-Face Acceptance and Commitment Therapy and Compassion-Based Intervention', 'ACT and compassion-focused intervention named Living with Intention, Fullness, and Engagement with Inflammatory Bowel Disease (LIFEwithIBD) intervention + Treatment As Usual (TAU) vs. TAU', 'conditions [experimental group (LIFEwithIBD + TAU) or control group (TAU']","['psychological distress, quality of life, work and social functioning, IBD symptom perception, illness-related shame, psychological flexibility, self-compassion, disease activity, inflammation biomarkers, and gut microbiota diversity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0587581', 'cui_str': 'Gastroenterology service'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",61.0,0.147499,"The LIFEwithIBD intervention is an adaptation to the IBD population of the Mind programme for people with cancer, an acceptance, mindfulness, and compassion-based intervention designed to be delivered in a group format.","[{'ForeName': 'Inês A', 'Initials': 'IA', 'LastName': 'Trindade', 'Affiliation': 'Faculty of Psychology and Education Sciences, CINEICC, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Pereira', 'Affiliation': 'Faculty of Psychology and Education Sciences, CINEICC, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Galhardo', 'Affiliation': 'Faculty of Psychology and Education Sciences, CINEICC, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Nuno B', 'Initials': 'NB', 'LastName': 'Ferreira', 'Affiliation': 'School of Social Sciences, University of Nicosia, Nicosia, Cyprus.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Lucena-Santos', 'Affiliation': 'Faculty of Psychology and Education Sciences, CINEICC, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Sérgio A', 'Initials': 'SA', 'LastName': 'Carvalho', 'Affiliation': 'Faculty of Psychology and Education Sciences, CINEICC, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Oliveira', 'Affiliation': 'Faculty of Psychology and Education Sciences, CINEICC, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Skvarc', 'Affiliation': 'School of Psychology, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Bárbara S', 'Initials': 'BS', 'LastName': 'Rocha', 'Affiliation': 'Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Portela', 'Affiliation': 'Gastroenterology Service, Centro Hospitalar e Universitário de Coimbra (CHUC), Coimbra, Portugal.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Psychology and Education Sciences, CINEICC, University of Coimbra, Coimbra, Portugal.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2021.699367']
908,34514653,The effects of earplugs and eye masks on sleep quality of patients admitted to coronary care units: A randomised clinical trial.,"Sleep is an essential need for patients admitted to coronary care units. The present clinical trial aimed to determine the effect of using eye masks and earplugs on the sleep quality of patients with coronary heart disease (CHD). A total of 68 eligible patients with CHD were randomly allocated into four groups of 17 (control, eye masks, earplugs, and eye masks with earplugs). All three interventions were performed during the night from 10:00 p.m. to 7:00 a.m. the next day. The outcomes were the quality of sleep, measured by the Verran and Snyder-Halpern (VSH) Sleep Scale, and the urinary levels of nocturnal melatonin and cortisol, measured by urine samples taken during the night (from 10:00 p.m. to 7:00 a.m.). The study outcomes were measured on the third and fourth days. Sleep disturbance was statistically significantly lower in patients with earplugs (visual analogue scale mean difference [MD]: 74.31 mm, SE: 11.34, p = 0.001). Sleep effectiveness was statistically significantly higher in patients with eye mask (MD: 36.88 mm, SE: 8.75, p = 0.001). The need for sleep supplementation was statistically significantly lower in patients with eye masks (MD: 39.79 mm, SE: 7.23, p = 0.001). There was a significant difference in melatonin levels between eye masks and the control group (p = 0.03). For urinary cortisol levels, there were significant differences between eye masks and the control group (p = 0.007), earplugs and the control group (p = 0.001), and eye masks with earplugs and the control group (p = 0.006). The mean scores for comfort, effectiveness, and ease of use were highest for the group that used eye masks (2.88, 2.94, and 3.18, respectively). As a result, all three interventions improved the sleep quality of patients. However, the interventions had different effects on the three dimensions of the VSH Sleep Scale, as well as the urinary levels of cortisol and melatonin.",2022,"For urinary cortisol levels, there were significant differences between eye masks and the control group (p = 0.007), earplugs and the control group (p = 0.001), and eye masks with earplugs and the control group (p = 0.006).","['68 eligible patients with CHD', 'patients admitted to coronary care units', 'patients with coronary heart disease (CHD']","['17 (control, eye masks, earplugs, and eye masks with earplugs', 'eye masks and earplugs', 'earplugs and eye masks']","['urinary cortisol levels', 'quality of sleep, measured by the Verran and Snyder-Halpern (VSH) Sleep Scale, and the urinary levels of nocturnal melatonin and cortisol, measured by urine samples taken during the night', 'VSH Sleep Scale', 'melatonin levels', 'mean scores for comfort, effectiveness, and ease of use', 'urinary levels of cortisol and melatonin', 'need for sleep supplementation', 'Sleep effectiveness', 'Sleep disturbance', 'sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0010066', 'cui_str': 'Coronary Care Units'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0181752', 'cui_str': 'Eye mask'}, {'cui': 'C1135964', 'cui_str': 'Ear plug'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]",68.0,0.0215357,"For urinary cortisol levels, there were significant differences between eye masks and the control group (p = 0.007), earplugs and the control group (p = 0.001), and eye masks with earplugs and the control group (p = 0.006).","[{'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Khoddam', 'Affiliation': 'Nursing Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Seyedmahrokh A', 'Initials': 'SA', 'LastName': 'Maddah', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Sommayeh', 'Initials': 'S', 'LastName': 'Rezvani Khorshidi', 'Affiliation': 'Department of Medical-Surgical Nursing, Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Zaman Kamkar', 'Affiliation': 'Department of Psychiatry, Golestan Research Center of Psychiatry, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Modanloo', 'Affiliation': 'Nursing Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}]",Journal of sleep research,['10.1111/jsr.13473']
909,34993933,"A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of Subcutaneous Eflapegrastim in Healthy Japanese and Caucasian Subjects.","BACKGROUND


Eflapegrastim (Rolontis ® ) is a novel long-acting pegylated recombinant human granulocyte colony-stimulating factor (G-CSF). Eflapegrastim has been developed to reduce the duration and incidence of chemotherapy-induced neutropenia in cancer patients using patient-friendly, less-frequent administration.
OBJECTIVE


This phase I study aimed to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of eflapegrastim following a single subcutaneous administration to healthy Japanese and Caucasian subjects.
METHODS


A randomized, double-blind, placebo- and active-controlled, dose-escalation study was conducted in healthy Japanese and Caucasian subjects. Eligible subjects randomly received a single subcutaneous administration of eflapegrastim (1.1, 3.3, 10, 45, 135, and 270 μg/kg), pegfilgrastim 6 mg, or placebo in a ratio of 6:2:2 (Cohorts 1-2, Caucasian subjects only) or 12:2:2 (Cohorts 3-6, Japanese and Caucasian subjects). Safety and tolerability were assessed throughout the study. Serial blood samples were collected predose and up to day 22 postdose for PK and PD analyses. PK assessments were performed in the 45, 135, and 270 µg/kg dose groups. Antidrug antibodies to eflapegrastim were determined at baseline up to day 42 after the first dose for immunogenicity.
RESULTS


A total of 84 subjects (42 males and 42 females) were enrolled, and 78 (31 Japanese and 47 Caucasian subjects) completed the study as planned. Japanese and Caucasian subjects showed similar PK and PD profiles. In the 45, 135, and 270 µg/kg dose groups, the maximum serum concentration (C max ) of eflapegrastim exhibited a dose-proportional increase, whereas its exposure increased greater than dose proportional in both ethnic groups. The mean area under the effect-time curve (AUEC last ) and maximum serum concentration of both absolute neutrophil count (ANC max ) and CD34 +  cell count (CD34 + max ) increased in a dose-dependent manner. There were no significant adverse events attributable to eflapegrastim or pegfilgrastim in both Japanese and Caucasian subjects. No neutralizing antibodies against G-CSF were detected.
CONCLUSIONS


Eflapegrastim was safe and well tolerated at doses up to 270 μg/kg in healthy Japanese and Caucasian subjects. In both ethnic groups, eflapegrastim showed dose-dependent PK and the exposure to eflapegrastim was positively correlated with ANC and CD34 +  cell count. The comparable PK and PD profiles of eflapegrastim in Japanese and Caucasian subjects may indicate the same dosage regimen is acceptable.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov: NCT01037543 (23 December 2009).",2022,There were no significant adverse events attributable to eflapegrastim or pegfilgrastim in both Japanese and Caucasian subjects.,"['Healthy Japanese and Caucasian Subjects', 'Japanese and Caucasian subjects', 'healthy Japanese and Caucasian subjects', '84 subjects (42 males and 42 females) were enrolled, and 78 (31 Japanese and 47 Caucasian subjects']","['placebo', 'pegfilgrastim 6 mg, or placebo', 'single subcutaneous administration of eflapegrastim', 'Placebo', 'Subcutaneous Eflapegrastim', 'pegfilgrastim']","['Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles', 'mean area under the effect-time curve (AUEC last ) and maximum serum concentration of both absolute neutrophil count (ANC max ) and CD34 +  cell count (CD34 + max ', 'safe and well tolerated', 'safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of eflapegrastim', 'neutralizing antibodies against G-CSF', 'Safety and tolerability', 'maximum serum concentration (C max ) of eflapegrastim']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0054953', 'cui_str': 'Lymphocyte antigen CD34'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}]",84.0,0.152278,There were no significant adverse events attributable to eflapegrastim or pegfilgrastim in both Japanese and Caucasian subjects.,"[{'ForeName': 'Yoomin', 'Initials': 'Y', 'LastName': 'Jeon', 'Affiliation': 'Department of Applied Biomedical Engineering, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, 08826, South Korea.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Hanmi Pharmaceutical Co., Ltd., Seoul, 05545, South Korea.'}, {'ForeName': 'Seungjae', 'Initials': 'S', 'LastName': 'Baek', 'Affiliation': 'Hanmi Pharmaceutical Co., Ltd., Seoul, 05545, South Korea.'}, {'ForeName': 'JaeDuk', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Hanmi Pharmaceutical Co., Ltd., Seoul, 05545, South Korea.'}, {'ForeName': 'Stanford', 'Initials': 'S', 'LastName': 'Jhee', 'Affiliation': 'Parexel International, Glendale, CA, 91206, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Applied Biomedical Engineering, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, 08826, South Korea. howardlee@snu.ac.kr.'}]",Drugs in R&D,['10.1007/s40268-021-00379-8']
910,34529293,Dance and yoga reduced functional abdominal pain in young girls: A randomized controlled trial.,"BACKGROUND


Functional abdominal pain disorders (FAPDs) affect children, especially girls, all over the world. The evidence for existing treatments is mixed, and effective accessible treatments are needed. Dance, a rhythmic cardio-respiratory activity, combined with yoga, which enhances relaxation and focus, may provide physiological and psychological benefits that could help to ease pain.
OBJECTIVES


The aim of this study was to evaluate the effect of a dance and yoga intervention on maximum abdominal pain in 9- to 13-year- old girls with FAPDs.
METHODS


This study was a prospective randomized controlled trial with 121 participants recruited from outpatient clinics as well as the general public. The intervention group participated in dance and yoga twice weekly for 8 months; controls received standard care. Abdominal pain, as scored on the Faces Pain Scale-Revised, was recorded in a pain diary. A linear mixed model was used to estimate the outcomes and effect sizes.
RESULTS


Dance and yoga were superior to standard health care alone, with a medium to high between-group effect size and significantly greater pain reduction (b = -1.29, p = 0.002) at the end of the intervention.
CONCLUSIONS


An intervention using dance and yoga is likely a feasible and beneficial complementary treatment to standard health care for 9- to 13-year-old girls with FAPDs.
SIGNIFICANCE


FAPDs affect children, especially girls, all over the world. The negative consequences such as absence from school, high consumption of medical care and depression pose a considerable burden on children and their families and effective treatments are needed. This is the first study examining a combined dance/yoga intervention for young girls with FAPDs and the result showed a reduction of abdominal pain. These findings contribute with new evidence in the field of managing FAPDs in a vulnerable target group.",2022,"RESULTS


Dance and yoga were superior to standard healthcare alone, with a medium to high between-group effect size and significantly greater pain reduction (b = -1.29, p = 0.002) at the end of the intervention.
","['Young Girls', '121 participants recruited from outpatient clinics as well as the general public', '9- to 13-year- old girls with FAPDs', '9- to 13-year-old girls with FAPDs']","['dance and yoga twice weekly for 8 months; controls received standard care', 'dance and yoga intervention']","['maximum abdominal pain', 'Functional Abdominal Pain', 'pain reduction', 'Abdominal pain']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",121.0,0.0839611,"RESULTS


Dance and yoga were superior to standard healthcare alone, with a medium to high between-group effect size and significantly greater pain reduction (b = -1.29, p = 0.002) at the end of the intervention.
","[{'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Högström', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Philipson', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Ekstav', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'Faculty of Medicine and Health, School of Health Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Ulrika L', 'Initials': 'UL', 'LastName': 'Fagerberg', 'Affiliation': 'Department of Pediatrics, Center for Clinical Research, Västmanland Hospital, Västerås, Uppsala University Uppsala, Västerås, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Falk', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Möller', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Sandberg', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Särnblad', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Duberg', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}]","European journal of pain (London, England)",['10.1002/ejp.1862']
911,34503879,"Corrigendum to ""Randomized Controlled Trial for Paclitaxel Coated Balloon Versus Plain Balloon Angioplasty in Dysfunctional Haemodialysis Vascular Access: 12-month outcome from a non-sponsored trial"" [Annals of Vascular Surgery 72C (2021) 299-306].",,2022,,['Dysfunctional Haemodialysis Vascular Access'],"['Plain Balloon Angioplasty', 'Paclitaxel Coated Balloon']",['Vascular Surgery 72C (2021'],"[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}]","[{'cui': 'C0042381', 'cui_str': 'Vascular surgery procedure'}]",,0.237588,,"[{'ForeName': 'Skyi Y C', 'Initials': 'SYC', 'LastName': 'Pang', 'Affiliation': 'Department of Surgery, Pamela Youde Nethersole Eastern Hospital, Hong Kong. Electronic address: pangyc2@ha.org.hk.'}, {'ForeName': 'Karen C L', 'Initials': 'KCL', 'LastName': 'Au-Yeung', 'Affiliation': 'Department of Surgery, Pamela Youde Nethersole Eastern Hospital, Hong Kong.'}, {'ForeName': 'Grace Y L', 'Initials': 'GYL', 'LastName': 'Liu', 'Affiliation': 'Department of Surgery, Pamela Youde Nethersole Eastern Hospital, Hong Kong.'}, {'ForeName': 'Ronald O H', 'Initials': 'ROH', 'LastName': 'Tse', 'Affiliation': 'Department of Surgery, Pamela Youde Nethersole Eastern Hospital, Hong Kong.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Lai', 'Affiliation': 'Department of Radiology, Pamela Youde Nethersole Eastern Hospital Hong Kong.'}, {'ForeName': 'Warren K W', 'Initials': 'WKW', 'LastName': 'Leung', 'Affiliation': 'Department of Radiology, Pamela Youde Nethersole Eastern Hospital Hong Kong.'}, {'ForeName': 'Ka Leung', 'Initials': 'KL', 'LastName': 'Mo', 'Affiliation': 'Department of Medicine, Pamela Youde Nethersole Eastern Hospital, Hong Kong.'}, {'ForeName': 'Chung Ngai', 'Initials': 'CN', 'LastName': 'Tang', 'Affiliation': 'Department of Surgery, Pamela Youde Nethersole Eastern Hospital, Hong Kong.'}]",Annals of vascular surgery,['10.1016/j.avsg.2021.09.001']
912,34510314,Brief Report: Perceptions of Family-Centered Care Across Service Delivery Systems and Types of Caregiver Concerns About Their Toddlers' Development.,"Family-centered care represents a collaborative partnership between caregivers and service providers, and is associated with positive caregiver and child outcomes. This approach may be especially important for caregivers with early concerns about autism, as service providers are often the gateway to appropriately-specialized intervention. Perceptions of family-centered care received from primary care providers (PCPs) and Part C Early Intervention (EI) providers were rated by two groups of caregivers: those concerned about autism (n = 37) and those concerned about another developmental problem (n = 22), using the Measure of Processes of Care (MPOC-20). Ratings did not differ across caregiver groups, but both groups rated EI providers significantly higher than PCPs, which may reflect systems-level differences between primary care and EI.",2021,"Family-centered care represents a collaborative partnership between caregivers and service providers, and is associated with positive caregiver and child outcomes.",[],['family-centered care received from primary care providers (PCPs) and Part C Early Intervention (EI) providers'],[],[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}]",[],,0.114934,"Family-centered care represents a collaborative partnership between caregivers and service providers, and is associated with positive caregiver and child outcomes.","[{'ForeName': 'Catherine C', 'Initials': 'CC', 'LastName': 'Dick', 'Affiliation': 'Department of Psychology, University of Washington, Box 351525, Seattle, WA, 98195, USA. ccdick@uw.edu.'}, {'ForeName': 'Lisa V', 'Initials': 'LV', 'LastName': 'Ibañez', 'Affiliation': 'Department of Psychology, University of Washington, Box 351525, Seattle, WA, 98195, USA.'}, {'ForeName': 'Trent D', 'Initials': 'TD', 'LastName': 'DesChamps', 'Affiliation': 'Department of Psychology, University of Washington, Box 351525, Seattle, WA, 98195, USA.'}, {'ForeName': 'Shana M', 'Initials': 'SM', 'LastName': 'Attar', 'Affiliation': 'Department of Psychology, University of Washington, Box 351525, Seattle, WA, 98195, USA.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Stone', 'Affiliation': 'Department of Psychology, University of Washington, Box 351525, Seattle, WA, 98195, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-021-05248-6']
913,34520092,Two-year follow-up of trauma-focused cognitive behavior therapy for posttraumatic stress disorder in emergency service personnel: A randomized clinical trial.,"BACKGROUND


Emergency service personnel experience elevated rates of posttraumatic stress disorder (PTSD). There are few controlled trials for PTSD in this population, and none report longer term effects of treatment. This study evaluated the benefits of cognitive behavior therapy (CBT) for PTSD in emergency service personnel who received either brief exposure (CBT-B) to trauma memories or prolonged exposure (CBT-L) 2 years following treatment.
METHODS


One hundred emergency service personnel with PTSD were randomized to CBT-L, CBT-B, or Wait-List (WL). Following posttreatment assessment, WL participants were randomized to an active treatment. Participants randomized to CBT-L or CBT-B were assessed at baseline, posttreatment, 6-month, and 2-year follow-up. Both CBT conditions involved 12 weekly individual sessions comprising education, CBT skills building, imaginal exposure, in vivo exposure, cognitive restructuring, and relapse prevention. Reliving trauma memories occurred for 40 min per session in CBT-L and for 10 min in CBT-B.
RESULTS


At the 2-year follow-up, there were no differences in PTSD severity (Clinician Administered PTSD Scale) between CBT-L and CBT-B. There were very large effect sizes for CBT-L (1.28, 95% confidence interval [CI] = 0.90-1.64) and CBT-B (1.28, 95% CI = 0.05-1.63) from baseline to 2-year follow-up.
CONCLUSIONS


This study highlights that CBT can be an effective treatment of PTSD in emergency service personnel using either prolonged or brief periods of reliving the trauma memory, and that these benefits can last for at least 2 years after treatment.",2021,"There were very large effect sizes for CBT-L (1.28, 95% confidence interval [CI] = 0.90-1.64) and CBT-B (1.28, 95% CI = 0.05-1.63) from baseline to 2-year follow-up.
","['posttraumatic stress disorder in emergency service personnel', 'PTSD in emergency service personnel who received either brief exposure (CBT-B) to trauma memories or prolonged exposure (CBT-L) 2 years following treatment', 'One hundred emergency service personnel with PTSD']","['CBT-L, CBT-B, or Wait-List (WL', 'cognitive behavior therapy (CBT', 'trauma-focused cognitive behavior therapy', 'CBT']","['Reliving trauma memories', 'PTSD severity (Clinician Administered PTSD Scale']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",100.0,0.0898779,"There were very large effect sizes for CBT-L (1.28, 95% confidence interval [CI] = 0.90-1.64) and CBT-B (1.28, 95% CI = 0.05-1.63) from baseline to 2-year follow-up.
","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bryant', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Kenny', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Rawson', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cahill', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Joscelyne', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Garber', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Tockar', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Tran', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Dawson', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, New South Wales, Australia.'}]",Depression and anxiety,['10.1002/da.23214']
914,34521594,Nutrition Literacy Tailored Interventions May Improve Diet Behaviors in Outpatient Nutrition Clinics.,"OBJECTIVES


Nutrition literacy examines the intersection of nutrition knowledge and skills; however, no evidence shows interventions tailored to nutrition literacy deficits affect diet behaviors. This study examined the effects of nutrition interventions tailored to individual nutrition literacy deficits on improving diet-related behaviors.
METHODS


Five outpatient clinics were randomized to 2 arms. The nutrition literacy and diet behaviors of patients were assessed before intervention with a dietitian and again 1 month later. Intervention-arm dietitians received patient nutrition literacy levels and tailored interventions toward nutrition literacy weaknesses. Differences in diet behaviors between arms were analyzed using Mann-Whitney U-tests and within-arms using Wilcoxon signed-rank tests.
RESULTS


Intervention-arm patients improved 10 of 25 measured diet behaviors; control-arm patients improved 6 behaviors. Similarly, intervention-arm patients reported increased green vegetable consumption from baseline to follow-up (z = 2.00; P = 0.04).
CONCLUSIONS AND IMPLICATIONS


Nutrition interventions tailored toward nutrition literacy deficits may play an important role in improving patient diet behaviors.",2021,"Similarly, intervention-arm patients reported increased green vegetable consumption from baseline to follow-up (z = 2.00; P = 0.04).
","['Five outpatient clinics', 'Outpatient Nutrition Clinics']","['Intervention-arm dietitians received patient nutrition literacy levels and tailored interventions toward nutrition literacy weaknesses', 'Nutrition Literacy Tailored Interventions', 'nutrition interventions']","['diet behaviors', 'green vegetable consumption', 'Diet Behaviors']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0195791,"Similarly, intervention-arm patients reported increased green vegetable consumption from baseline to follow-up (z = 2.00; P = 0.04).
","[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Marchello', 'Affiliation': 'School of Nutrition, Kinesiology, and Psychological Science, University of Central Missouri, Warrensburg, MO.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Daley', 'Affiliation': 'Department of Family Medicine Research, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Sullivan', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Heather V', 'Initials': 'HV', 'LastName': 'Nelson-Brantley', 'Affiliation': 'School of Nursing, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Jinxiang', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Biostatistics and Data Science, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Gibbs', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS. Electronic address: hgibbs@kumc.edu.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2021.07.013']
915,34492326,Impact of sterile gloves on blood-culture contamination rates: A randomized clinical trial.,"BACKGROUND


Reducing the blood-culture contamination rate is a constant challenge for health services. This study aimed to analyze whether blood-culture (BC) collection using sterile gloves reduces the contamination rate when compared to the non-sterile gloves, and to compare baseline and intervention periods.
METHODS


A randomized clinical trial, performed in an intensive care unit in Brazil and paired in two groups: sterile (BCs obtained with modified sterile technique: only sterile gloves; no fenestrated drape or dedicated sterile collection kit) and clean (clean technique: usual care with non-sterile gloves). Two paired blood samples were obtained from each patient by trained and calibrated nurses. BCs were processed by conventional microbiological methods and the results were issued by blinded microbiologists.
RESULTS


There was no difference (P = 1.00) in the contamination rate of BC between the sterile (1%) and clean (1%) groups. However, there was a significant difference (P = 0.05; relative risk: 0.17; 95% confidence interval: 0.04-0.70) in the contamination rate between baseline (6.1%; 20/330) and intervention (1%; 2/200).
CONCLUSIONS


This study suggests that the aseptic care provided in obtaining samples is more important than the sterile technique itself, and highlights the value of standardizing the practices, qualification and calibration of phlebotomists.",2022,There was no difference (p=1.00) in the contamination rate of BC between the sterile (1%) and clean (1%) groups.,['intensive care unit in Brazil and paired in two groups'],"['sterile (BCs obtained with modified sterile technique: only sterile gloves; no fenestrated drape or dedicated sterile collection kit) and clean (clean technique: usual care with non-sterile gloves', 'blood-culture (BC) collection using sterile gloves', 'sterile gloves']","['contamination rate', 'contamination rate of BC', 'blood-culture contamination', 'blood-culture contamination rates']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0200949', 'cui_str': 'Blood culture'}]","[{'cui': 'C0200949', 'cui_str': 'Blood culture'}]",,0.341847,There was no difference (p=1.00) in the contamination rate of BC between the sterile (1%) and clean (1%) groups.,"[{'ForeName': 'Oleci Pereira', 'Initials': 'OP', 'LastName': 'Frota', 'Affiliation': 'School of Nursing, Universidade Federal de Mato Grosso do Sul, Campo Grande, Brazil. Electronic address: olecifrota@gmail.com.'}, {'ForeName': 'Raysa Muriel', 'Initials': 'RM', 'LastName': 'Silva', 'Affiliation': 'School of Nursing, Universidade Federal de Mato Grosso do Sul, Campo Grande, Brazil; School of Nursing, Universidade de Brasília, Brasília, Brazil.'}, {'ForeName': 'Juliana Silva', 'Initials': 'JS', 'LastName': 'Ruiz', 'Affiliation': 'School of Nursing, Universidade Federal de Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Marcos Antonio', 'Initials': 'MA', 'LastName': 'Ferreira-Júnior', 'Affiliation': 'School of Nursing, Universidade Federal de Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Paula Regina de Souza', 'Initials': 'PRS', 'LastName': 'Hermann', 'Affiliation': 'School of Nursing, Universidade de Brasília, Brasília, Brazil.'}]",American journal of infection control,['10.1016/j.ajic.2021.08.030']
916,34498507,Eculizumab monotherapy for NMOSD: Data from PREVENT and its open-label extension.,"During PREVENT (a phase 3, randomized, double-blind, placebo-controlled, time-to-event study) and its open-label extension (interim analysis), 33 adults with aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder (AQP4-IgG + NMOSD) received eculizumab monotherapy for a median of 2.8 years (range, 14 weeks-5.2 years). At 192 weeks (~4 years), 96% of these patients were free from adjudicated relapses (Kaplan-Meier analysis; 95% confidence interval, 75.7-99.4). During PREVENT, 95% (20/21) of patients receiving eculizumab monotherapy had no disability worsening. Eculizumab monotherapy provides effective long-term relapse prevention, relieving the chronic immunosuppression burden in patients with AQP4-IgG + NMOSD. ClinicalTrials.gov; PREVENT: NCT01892345; open-label extension: NCT02003144.",2022,"At 192 weeks (~4 years), 96% of these patients were free from adjudicated relapses (Kaplan-Meier analysis; 95% confidence interval, 75.7-99.4).","['patients with AQP4-IgG + NMOSD', 'for a median of 2.8 years (range, 14 weeks-5.2 years', '33 adults with aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder (AQP4-IgG + NMOSD']","['eculizumab monotherapy', 'placebo', 'Eculizumab monotherapy']",['disability worsening'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0292777', 'cui_str': 'Aquaporin-4'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027873', 'cui_str': 'Neuromyelitis optica'}]","[{'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]",33.0,0.295436,"At 192 weeks (~4 years), 96% of these patients were free from adjudicated relapses (Kaplan-Meier analysis; 95% confidence interval, 75.7-99.4).","[{'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Pittock', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Fujihara', 'Affiliation': 'Department of Neurology, Tohoku University Graduate School of Medicine, Sendai, Japan/Department of Multiple Sclerosis Therapeutics, Fukushima Medical University, Fukushima City, Japan/Multiple Sclerosis and Neuromyelitis Optica Center, Southern TOHOKU Research Institute for Neuroscience (STRINS), Koriyama, Japan.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Palace', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Berthele', 'Affiliation': 'Department of Neurology, School of Medicine, Klinikum rechts der Isar of the Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Ho Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Oreja-Guevara', 'Affiliation': 'Department of Neurology, Hospital Clinico Universitario San Carlos, Madrid, Spain/Department of Medicine, Universidad Complutense de Madrid, Madrid, Spain/IdISSC, Madrid, Spain.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Nakashima', 'Affiliation': 'Department of Neurology, Tohoku University Graduate School of Medicine, Sendai, Japan/Division of Neurology, Tohoku Medical and Pharmaceutical University, Sendai, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Levy', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, MD, USA/Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Shulian', 'Initials': 'S', 'LastName': 'Shang', 'Affiliation': 'Alexion Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Yountz', 'Affiliation': 'Alexion Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'Alexion Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Róisín', 'Initials': 'R', 'LastName': 'Armstrong', 'Affiliation': 'Alexion Pharmaceuticals, Boston, MA, USA/Rallybio, New Haven, CT, USA.'}, {'ForeName': 'Dean M', 'Initials': 'DM', 'LastName': 'Wingerchuk', 'Affiliation': 'Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/13524585211038291']
917,34499613,"A Web-Based Cognitive Behavioral Therapy, Mindfulness Meditation, and Yoga Intervention for Posttraumatic Stress Disorder: Single-Arm Experimental Clinical Trial.","BACKGROUND


Posttraumatic stress disorder (PTSD) is a debilitating, undertreated condition. The web-based delivery of cognitive behavioral therapy supplemented with mindfulness meditation and yoga is a viable treatment that emphasizes self-directed daily practice.
OBJECTIVE


This study aims to examine the effectiveness of a web-based cognitive behavioral therapy, mindfulness, and yoga (CBT-MY) program designed for daily use.
METHODS


We conducted an 8-week, single-arm, experimental, registered clinical trial on adults reporting PTSD symptoms (n=22; aged 18-35 years). Each participant received web-based CBT-MY content and an hour of web-based counseling each week. Pre-post outcomes included self-reported PTSD symptom severity, depression, anxiety, chronic pain, and mindfulness. Pre-post psychophysiological outcomes included peak pupil dilation (PPD) and heart rate variability (HRV). HRV and PPD were also compared with cross-sectional data from a non-PTSD comparison group without a history of clinical mental health diagnoses and CBT-MY exposure (n=46).
RESULTS


Pre-post intention-to-treat analyses revealed substantial improvements in PTSD severity (d=1.60), depression (d=0.83), anxiety (d=0.99), and mindfulness (d=0.88). Linear multilevel mixed models demonstrated a significant pre-post reduction in PPD (B=-0.06; SE=0.01; P<.001; d=0.90) but no significant pre-post change in HRV (P=.87). Overall, participants spent an average of 11.53 (SD 22.76) min/day on self-directed mindfulness practice.
CONCLUSIONS


Web-based CBT-MY was associated with clinically significant symptom reductions and significant PPD changes, suggesting healthier autonomic functioning. Future randomized controlled trials are needed to further examine the gains apparent in this single-arm study.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03684473; https://clinicaltrials.gov/ct2/show/NCT03684473.",2022,"RESULTS


Pre-post intention-to-treat analyses revealed substantial improvements in PTSD severity (d = 1.60), depression (d = 0.83), anxiety (d = 0.99), and mindfulness (d = 0.88).","['Posttraumatic Stress Disorder', 'sample of adults, ages 18-35 years, with PTSD symptoms (n = 22', 'Posttraumatic Stress Disorder (PTSD']","['cognitive behavioural therapy supplemented with mindfulness meditation and yoga', 'Online Cognitive Behavioral Therapy, Mindfulness Meditation, and Yoga (CBT-MY) Intervention', 'online CBT-MY content and an hour of online counselling each week', 'online cognitive behaviour therapy program combined with mindfulness and yoga methods (CBT-MY']","['PTSD severity', 'breath awareness techniques', 'PTSD symptom severity, depression, anxiety, chronic pain, and mindfulness. Pre-post psychophysiological outcomes were pupillometry and heart rate variability (HRV', 'peak pupil diameter (PPD', 'clinical mental health diagnoses', 'depression', 'normalized autonomic function', 'anxiety']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",46.0,0.0899883,"RESULTS


Pre-post intention-to-treat analyses revealed substantial improvements in PTSD severity (d = 1.60), depression (d = 0.83), anxiety (d = 0.99), and mindfulness (d = 0.88).","[{'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Kirk', 'Affiliation': 'School of Kinesiology and Health Sciences, York University, Toronto, ON, Canada.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Taha', 'Affiliation': 'Department of Electrical and Computer Engineering, Faculty of Applied Science and Engineering, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Dang', 'Affiliation': 'School of Kinesiology and Health Sciences, York University, Toronto, ON, Canada.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'McCague', 'Affiliation': 'Institute for Social Research, York University, Toronto, ON, Canada.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Hatzinakos', 'Affiliation': 'Department of Electrical and Computer Engineering, Faculty of Applied Science and Engineering, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of Psychology, York University, Toronto, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ritvo', 'Affiliation': 'School of Kinesiology and Health Sciences, York University, Toronto, ON, Canada.'}]",JMIR mental health,['10.2196/26479']
918,34510196,Durable Cognitive Gains and Symptom Improvement Are Observed in Individuals With Recent-Onset Schizophrenia 6 Months After a Randomized Trial of Auditory Training Completed Remotely.,"OBJECTIVE


Cognitive impairment in schizophrenia predicts functional outcomes and is largely unresponsive to pharmacology or psychotherapy; it is thus a critical unmet treatment need. This article presents the impact of remotely completed, intensive, targeted auditory training (AT) vs control condition computer games (CG) in a double-blind randomized trial in young adults with recent-onset schizophrenia.
METHOD


Participants (N = 147) were assessed for cognition, symptoms, and functioning at baseline, post-intervention, and at 6-month follow-up. All participants were provided with laptop computers and were instructed to complete 40 hours remotely of training or computer games. An intent-to-treat analysis (N = 145) was performed using linear mixed models with time modeled as a continuous variable. Planned contrasts tested the change from baseline to post-training, baseline to 6-month follow-up, and post-training to 6-month follow-up.
RESULTS


Global Cognition, which had improved in the AT group relative to the CG group at post-training, showed durable gains at 6-month follow-up in an omnibus group-by-time interaction test (F(1,179) = 4.80, P = .030), as did Problem-Solving (F(1,179) = 5.13, P = .025), and Speed of Processing improved at trend level significance (F(1,170) = 3.80, P = .053). Furthermore, the AT group showed significantly greater improvement than the CG group in positive symptoms (F(1,179) = 4.06, P = .045).
CONCLUSIONS


These results provide the first evidence of durable cognitive gains and symptom improvement at follow-up of cognitive training (CT) in early schizophrenia completed independently and remotely. While functioning did not show significant improvement, these findings suggest that intensive targeted CT of auditory processing is a promising component of early intervention to promote recovery from psychosis.",2022,"Furthermore, the AT group showed significantly greater improvement than the CG group in positive symptoms (F(1,179) =","['young adults with recent-onset schizophrenia', 'Participants (N = 147) were assessed for cognition, symptoms, and functioning at baseline, post-intervention, and at 6-month follow-up', 'Individuals With Recent-Onset Schizophrenia 6 Months']","['Auditory Training Completed Remotely', 'auditory training (AT) vs control condition computer games (CG', 'cognitive training (CT', 'CG', 'psychotherapy']","['Durable Cognitive Gains and Symptom Improvement', 'durable gains']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}]",147.0,0.0569762,"Furthermore, the AT group showed significantly greater improvement than the CG group in positive symptoms (F(1,179) =","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Loewy', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Sisi', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'School of Medicine, Division of General Internal Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Carter', 'Affiliation': 'Department of Psychiatry, University of California, Davis, Davis, CA, USA.'}, {'ForeName': 'J Daniel', 'Initials': 'JD', 'LastName': 'Ragland', 'Affiliation': 'Department of Psychiatry, University of California, Davis, Davis, CA, USA.'}, {'ForeName': 'Tara A', 'Initials': 'TA', 'LastName': 'Niendam', 'Affiliation': 'Department of Psychiatry, University of California, Davis, Davis, CA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Stuart', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Schlosser', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Amirfathi', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Seghel', 'Initials': 'S', 'LastName': 'Yohannes', 'Affiliation': 'Department of Public Health, University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Minnesota, Minneapolis, MN, USA.'}]",Schizophrenia bulletin,['10.1093/schbul/sbab102']
919,34506326,Initial Laparotomy Versus Peritoneal Drainage in Extremely Low Birthweight Infants With Surgical Necrotizing Enterocolitis or Isolated Intestinal Perforation: A Multicenter Randomized Clinical Trial.,"OBJECTIVE


The aim of this study was to determine which initial surgical treatment results in the lowest rate of death or neurodevelopmental impairment (NDI) in premature infants with necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP).
SUMMARY BACKGROUND DATA


The impact of initial laparotomy versus peritoneal drainage for NEC or IP on the rate of death or NDI in extremely low birth weight infants is unknown.
METHODS


We conducted the largest feasible randomized trial in 20 US centers, comparing initial laparotomy versus peritoneal drainage. The primary outcome was a composite of death or NDI at 18 to 22 months corrected age, analyzed using prespecified frequentist and Bayesian approaches.
RESULTS


Of 992 eligible infants, 310 were randomized and 96% had primary outcome assessed. Death or NDI occurred in 69% of infants in the laparotomy group versus 70% with drainage [adjusted relative risk (aRR) 1.0; 95% confidence interval (CI): 0.87-1.14]. A preplanned analysis identified an interaction between preoperative diagnosis and treatment group (P = 0.03). With a preoperative diagnosis of NEC, death or NDI occurred in 69% after laparotomy versus 85% with drainage (aRR 0.81; 95% CI: 0.64-1.04). The Bayesian posterior probability that laparotomy was beneficial (risk difference <0) for a preoperative diagnosis of NEC was 97%. For preoperative diagnosis of IP, death or NDI occurred in 69% after laparotomy versus 63% with drainage (aRR, 1.11; 95% CI: 0.95-1.31); Bayesian probability of benefit with laparotomy = 18%.
CONCLUSIONS


There was no overall difference in death or NDI rates at 18 to 22 months corrected age between initial laparotomy versus drainage. However, the preoperative diagnosis of NEC or IP modified the impact of initial treatment.",2021,There was no overall difference in death or NDI rates at 18 to 22 months corrected age between initial laparotomy versus drainage.,"['premature infants with necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP', '992 eligible infants', 'Extremely Low Birthweight Infants With Surgical Necrotizing Enterocolitis or Isolated Intestinal Perforation', 'extremely low birth weight infants']","['initial laparotomy versus peritoneal drainage for NEC or IP', 'Initial Laparotomy Versus Peritoneal Drainage', 'initial laparotomy versus peritoneal drainage']","['death or neurodevelopmental impairment (NDI', 'preoperative diagnosis of IP, death or NDI', 'rate of death or NDI', 'Death or NDI', 'death or NDI rates', 'death or NDI', 'composite of death or NDI']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0021845', 'cui_str': 'Perforation of intestine'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0456065', 'cui_str': 'Extremely low birth weight infant'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0021845', 'cui_str': 'Perforation of intestine'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1318968', 'cui_str': 'Pre-op diagnosis'}, {'cui': 'C0021845', 'cui_str': 'Perforation of intestine'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",992.0,0.380061,There was no overall difference in death or NDI rates at 18 to 22 months corrected age between initial laparotomy versus drainage.,"[{'ForeName': 'Martin L', 'Initials': 'ML', 'LastName': 'Blakely', 'Affiliation': 'Department of Pediatric Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Tyson', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Lally', 'Affiliation': 'Department of Pediatric Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Hintz', 'Affiliation': ""Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA.""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Eggleston', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Stevenson', 'Affiliation': ""Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA.""}, {'ForeName': 'Gail E', 'Initials': 'GE', 'LastName': 'Besner', 'Affiliation': ""Department of Pediatric Surgery, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH.""}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Research Rockville, MD.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Ohls', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Truog', 'Affiliation': ""Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO.""}, {'ForeName': 'Leif D', 'Initials': 'LD', 'LastName': 'Nelin', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH.""}, {'ForeName': 'Brenda B', 'Initials': 'BB', 'LastName': 'Poindexter', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Michele C', 'Initials': 'MC', 'LastName': 'Walsh', 'Affiliation': ""Department of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH.""}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Stoll', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Geller', 'Affiliation': 'Department of Pediatrics, University of California, Los Angeles, CA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Kennedy', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Reed A', 'Initials': 'RA', 'LastName': 'Dimmitt', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Cotten', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, ND.'}, {'ForeName': 'Abbot R', 'Initials': 'AR', 'LastName': 'Laptook', 'Affiliation': ""Department of Pediatrics, Women's & Infants Hospital, Brown University, Providence, RI.""}, {'ForeName': 'Krisa P', 'Initials': 'KP', 'LastName': 'Van Meurs', 'Affiliation': ""Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA.""}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Calkins', 'Affiliation': 'Department of Pediatrics, University of California, Los Angeles, CA.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Sokol', 'Affiliation': 'Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Pablo J', 'Initials': 'PJ', 'LastName': 'Sanchez', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH.""}, {'ForeName': 'Myra H', 'Initials': 'MH', 'LastName': 'Wyckoff', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Ravi M', 'Initials': 'RM', 'LastName': 'Patel', 'Affiliation': ""Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta, GA.""}, {'ForeName': 'Ivan D', 'Initials': 'ID', 'LastName': 'Frantz', 'Affiliation': 'Department of Pediatrics, Division of Newborn Medicine, Floating Hospital for Children, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Seetha', 'Initials': 'S', 'LastName': 'Shankaran', 'Affiliation': 'Department of Pediatrics, Wayne State University, Detroit, MI.'}, {'ForeName': 'Carl T', 'Initials': 'CT', 'LastName': ""D'Angio"", 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Yoder', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Bell', 'Affiliation': 'Department of Pediatrics, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Kristi L', 'Initials': 'KL', 'LastName': 'Watterberg', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Martin', 'Affiliation': 'Division of Pediatric Surgery, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Carroll M', 'Initials': 'CM', 'LastName': 'Harmon', 'Affiliation': 'Division of Pediatric Surgery, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Rice', 'Affiliation': 'Division of Pediatric General Surgery, Duke University, Durham, NC.'}, {'ForeName': 'Arlet G', 'Initials': 'AG', 'LastName': 'Kurkchubasche', 'Affiliation': ""Department of Pediatric Surgery, Hasbro Children's Hospital, Brown University, Providence, RI.""}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Sylvester', 'Affiliation': 'Department of Pediatric Surgery, Stanford University School of Medicine, Palo Alto, CA.'}, {'ForeName': 'James C Y', 'Initials': 'JCY', 'LastName': 'Dunn', 'Affiliation': 'Department of Pediatric Surgery, Stanford University School of Medicine, Palo Alto, CA.'}, {'ForeName': 'Troy A', 'Initials': 'TA', 'LastName': 'Markel', 'Affiliation': 'Department of Pediatric Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Diesen', 'Affiliation': 'Department of Pediatric Surgery, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Amina M', 'Initials': 'AM', 'LastName': 'Bhatia', 'Affiliation': ""Department of Pediatric Surgery, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Flake', 'Affiliation': 'Department of Pediatric Surgery, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Chwals', 'Affiliation': 'Department of Pediatric Surgery, Floating Hospital for Children, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Rebeccah', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': ""Department of Pediatric Surgery, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Kathryn D', 'Initials': 'KD', 'LastName': 'Bass', 'Affiliation': ""Division of Pediatric Surgery, University of Buffalo, John R. Oishei Children's Hospital, Buffalo, NY.""}, {'ForeName': 'Shawn D', 'Initials': 'SD', 'LastName': 'St Peter', 'Affiliation': ""Department of Pediatric Surgery, Children's Mercy Hospital, Kansas City, MO.""}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Shanti', 'Affiliation': 'Department of Pediatric Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Pegoli', 'Affiliation': 'Department of Pediatric Surgery, University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Skarda', 'Affiliation': 'Department of Pediatric Surgery, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Shilyansky', 'Affiliation': 'Department of Surgery, University of Iowa, Iowa City, IA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Lemon', 'Affiliation': 'Department of Pediatric Surgery, University of New Mexico Health Sciences Center, Albuquerque, NM.'}, {'ForeName': 'Ricardo A', 'Initials': 'RA', 'LastName': 'Mosquera', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Peralta-Carcelen', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Ricki F', 'Initials': 'RF', 'LastName': 'Goldstein', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, ND.'}, {'ForeName': 'Betty R', 'Initials': 'BR', 'LastName': 'Vohr', 'Affiliation': ""Department of Pediatrics, Women's & Infants Hospital, Brown University, Providence, RI.""}, {'ForeName': 'Isabell B', 'Initials': 'IB', 'LastName': 'Purdy', 'Affiliation': 'Department of Pediatrics, University of California, Los Angeles, CA.'}, {'ForeName': 'Abbey C', 'Initials': 'AC', 'LastName': 'Hines', 'Affiliation': 'Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Nathalie L', 'Initials': 'NL', 'LastName': 'Maitre', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH.""}, {'ForeName': 'Roy J', 'Initials': 'RJ', 'LastName': 'Heyne', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'DeMauro', 'Affiliation': 'Department of Pediatrics, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Elisabeth C', 'Initials': 'EC', 'LastName': 'McGowan', 'Affiliation': ""Department of Pediatrics, Women's & Infants Hospital, Brown University, Providence, RI.""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Yolton', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Howard W', 'Initials': 'HW', 'LastName': 'Kilbride', 'Affiliation': ""Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO.""}, {'ForeName': 'Girija', 'Initials': 'G', 'LastName': 'Natarajan', 'Affiliation': 'Department of Pediatrics, Wayne State University, Detroit, MI.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Yost', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Winter', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Tarah T', 'Initials': 'TT', 'LastName': 'Colaizy', 'Affiliation': 'Department of Pediatrics, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Laughon', 'Affiliation': 'Division of Neonatal/Perinatal Medicine, Department of Pediatrics, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Satyanarayana', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Rosemary D', 'Initials': 'RD', 'LastName': 'Higgins', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000005099']
920,34514739,Nintedanib in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease: Subgroup Analyses by Autoantibody Status and Modified Rodnan Skin Thickness Score.,"OBJECTIVE


Using data from the SENSCIS trial, these analyses were undertaken to assess the effects of nintedanib versus placebo in subgroups of patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), based on characteristics previously identified as being associated with the progression of SSc-ILD.
METHODS


Patients with SSc-ILD were randomized to receive either nintedanib or placebo, stratified by anti-topoisomerase I antibody (ATA) status. We assessed the rate of decline in forced vital capacity (FVC) (expressed in ml/year) over 52 weeks in subgroups based on baseline ATA status, modified Rodnan skin thickness score (MRSS) (<18 versus ≥18), and SSc subtype (limited cutaneous SSc [lcSSc] versus diffuse cutaneous SSc [dcSSc]).
RESULTS


At baseline, 60.8% of 576 patients who received treatment with either nintedanib or placebo were positive for ATA, 51.9% had dcSSc, and 77.5% of 574 patients with MRSS data available had an MRSS of <18. The effect of nintedanib versus placebo on reducing the rate of decline in FVC (ml/year) was numerically more pronounced in ATA-negative patients compared to ATA-positive patients (adjusted difference in the rate of FVC decline, 57.2 ml/year [95% confidence interval (95% CI) -3.5, 118.0] versus 29.9 ml/year [95% CI -19.1, 78.8]), in patients with a baseline MRSS ≥18 compared to those with a baseline MRSS of <18 (adjusted difference in the rate of FVC decline, 88.7 ml/year [95% CI 7.7, 169.8] versus 26.4 ml/year [95% CI -16.8, 69.6]), and in patients with dcSSc compared to those with lcSSc (adjusted difference in the rate of FVC decline, 56.6 ml/year [95% CI 3.2, 110.0] versus 25.3 ml/year [95% CI -28.9, 79.6]). However, all exploratory interaction P values were nonsignificant (all P > 0.05), indicating that there was no heterogeneity in the effect of nintedanib versus placebo between these subgroups of patients.
CONCLUSION


In patients with SSc-ILD, reduction in the annual rate of decline in FVC among patients receiving nintedanib compared to those receiving placebo was not found to be heterogenous across subgroups based on ATA status, MRSS, or SSc subtype.",2022,"In patients with SSc-ILD, no heterogeneity was detected in the treatment effect of nintedanib in reducing the annual rate of decline in FVC across subgroups based on ATA status, mRSS, and SSc subtype.","['Patients with SSc-ILD', 'patients with systemic sclerosis-associated interstitial lung disease', 'subgroups of patients with SSc-ILD based on characteristics associated with progression of SSc-ILD in previous studies', '576 patients treated, 60.8% were ATA-positive, 51.9% had dcSSc, and 77.5% of 574 patients with mRSS data available had mRSS <18']","['placebo', 'lcSSc', 'nintedanib or placebo, stratified by anti-topoisomerase I antibody (ATA) status', 'Nintedanib', 'nintedanib versus placebo']","['modified Rodnan skin score (mRSS', 'rate of decline in forced vital capacity (FVC', 'rate of decline in FVC (mL/year']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0201360', 'cui_str': 'Antibody to SCL-70'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0201360', 'cui_str': 'Antibody to SCL-70'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0439234', 'cui_str': 'year'}]",574.0,0.428223,"In patients with SSc-ILD, no heterogeneity was detected in the treatment effect of nintedanib in reducing the annual rate of decline in FVC across subgroups based on ATA status, mRSS, and SSc subtype.","[{'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Allanore', 'Affiliation': 'Descartes University, AP-HP, and Cochin Hospital, Paris, France.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Denton', 'Affiliation': 'University College London Division of Medicine, London, UK.'}, {'ForeName': 'Jörg H W', 'Initials': 'JHW', 'LastName': 'Distler', 'Affiliation': 'University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Steen', 'Affiliation': 'Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Matucci-Cerinic', 'Affiliation': 'University of Florence, Florence, Italy.'}, {'ForeName': 'Maureen D', 'Initials': 'MD', 'LastName': 'Mayes', 'Affiliation': 'University of Texas McGovern Medical School, Houston.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Miede', 'Affiliation': 'mainanalytics, Sulzbach, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Gahlemann', 'Affiliation': 'Boehringer Ingelheim, Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Quaresma', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim, Germany.'}, {'ForeName': 'Margarida', 'Initials': 'M', 'LastName': 'Alves', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Distler', 'Affiliation': 'University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41965']
921,34511333,Long-Term Safety and Efficacy of Deutetrabenazine in Younger and Older Patients With Tardive Dyskinesia.,"OBJECTIVES


To assess long-term safety and efficacy of deutetrabenazine in younger (<55 years) and older (≥55 years) adult participants with tardive dyskinesia (TD).
DESIGN


Three-year, single-arm, open-label extension (OLE) study enrolling participants who completed the 12-week, pivotal ARM-TD or AIM-TD studies.
SETTING


Seventy-six centers in the United States and Europe.
PARTICIPANTS


A total of 337 participants with TD (119 younger and 218 older).
INTERVENTION


Deutetrabenazine was initiated at 12 mg/day and titrated once weekly by 6 mg/day using a response-driven dosing regimen until adequate dyskinesia control was reached or a clinically significant adverse event occurred.
MEASUREMENTS


This post hoc analysis assessed change and percent change from baseline in total motor Abnormal Involuntary Movement Scale (AIMS) score, response rates for ≥50% AIMS improvement, Clinical Global Impression of Change (CGIC), Patient Global Impression of Change (PGIC), and safety in younger and older participants with TD.
RESULTS


After 3 years of open-label treatment, mean deutetrabenazine dose was ∼39.5 mg/day in both groups. Mean±SE changes from baseline in total motor AIMS score were -6.7 ± 0.62 and -6.5 ± 0.47 in younger and older participants, respectively (percent changes: -61.4% ± 4.10% and -54.6% ± 3.01%); 76% of younger and 62% of older participants achieved ≥50% AIMS response. Most younger and older participants achieved treatment success per CGIC (67% and 76%) and PGIC (64% and 63%). Deutetrabenazine was generally well tolerated in both groups.
CONCLUSIONS


Deutetrabenazine treatment was associated with sustained improvements in total motor AIMS score, treatment success, and improved quality of life, and was well tolerated in younger and older adults with TD in this 3-year OLE study.",2022,"This post hoc analysis assessed change and percent change from baseline in total motor Abnormal Involuntary Movement Scale (AIMS) score, response rates for ≥50% AIMS improvement, Clinical Global Impression of Change (CGIC), Patient Global Impression of Change (PGIC), and safety in younger and older participants with TD.
","['younger and older participants with TD', 'A total of 337 participants with TD (119 younger and 218 older', 'Younger and Older Patients With Tardive Dyskinesia', 'Seventy-six centers in the United States and Europe', 'younger (<55 years) and older (≥55 years) adult participants with tardive dyskinesia (TD']","['deutetrabenazine', 'Deutetrabenazine']","['treatment success per CGIC', 'tolerated', 'total motor AIMS score, treatment success, and improved quality of life', 'total motor AIMS score', 'total motor Abnormal Involuntary Movement Scale (AIMS) score, response rates for ≥50% AIMS improvement, Clinical Global Impression of Change (CGIC), Patient Global Impression of Change (PGIC), and safety']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0686347', 'cui_str': 'Tardive dyskinesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4277781', 'cui_str': 'deutetrabenazine'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0450978', 'cui_str': 'Abnormal involuntary movement scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",337.0,0.0666769,"This post hoc analysis assessed change and percent change from baseline in total motor Abnormal Involuntary Movement Scale (AIMS) score, response rates for ≥50% AIMS improvement, Clinical Global Impression of Change (CGIC), Patient Global Impression of Change (PGIC), and safety in younger and older participants with TD.
","[{'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': 'University Hospitals Cleveland Medical Center (MS), Case Western Reserve University School of Medicine, Cleveland, OH. Electronic address: martha.sajatovic@uhhospitals.org.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Finkbeiner', 'Affiliation': 'Teva Pharmaceuticals (SF, AW, NCNG, MFG), West Chester, PA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Wilhelm', 'Affiliation': 'Teva Pharmaceuticals (SF, AW, NCNG, MFG), West Chester, PA.'}, {'ForeName': 'Hadas', 'Initials': 'H', 'LastName': 'Barkay', 'Affiliation': 'Teva Pharmaceuticals (HB), Netanya, Israel.'}, {'ForeName': 'Nayla', 'Initials': 'N', 'LastName': 'Chaijale', 'Affiliation': 'Teva Pharmaceuticals (SF, AW, NCNG, MFG), West Chester, PA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Gross', 'Affiliation': 'Teva Pharmaceuticals (SF, AW, NCNG, MFG), West Chester, PA.'}, {'ForeName': 'Mark Forrest', 'Initials': 'MF', 'LastName': 'Gordon', 'Affiliation': 'Teva Pharmaceuticals (SF, AW, NCNG, MFG), West Chester, PA.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2021.08.003']
922,34521576,The Efficacy of a Multi-Theory-Based Peer-Led Intervention on Oral Health Among Hong Kong Adolescents: A Cluster-Randomized Controlled Trial.,"PURPOSE


This study aimed to investigate the effects of a peer-led oral health intervention based on the Health Belief Model and the Social Cognitive Theory on improving oral health among Hong Kong adolescents.
METHODS


The study adopted a cluster-randomized controlled trial design, and 1184 students in 12 schools were randomized to intervention or control groups. After baseline assessment, the intervention group received a peer-led theory-based oral health intervention, while the control group received booklets for oral health promotion. Self-reported brushing and flossing, Health Belief Model/Social Cognitive Theory constructs, and oral health-related quality of life (OHRQoL) were measured at baseline, 6 months, and 12 months, and dental plaque accumulation and caries status were measured at baseline and 12 months. The trial was registered at https://www.clinicaltrials.gov (NCT03694496).
RESULTS


Brushing, flossing, and OHRQoL improved more in the experimental group than in the control group at the 6-month follow-up compared with baseline (p < .001). The mean gain score difference was .81 for brushing, .47 for flossing, and -2.51 for OHRQoL. At the 12-month follow-up, the mean gain score of brushing frequency, plaque index, caries status, and OHRQoL were .18, -.28, -.32, and -2.79, respectively, which all sustained the significant difference (p < .001).
CONCLUSIONS


Our findings suggested that the Health Belief Model combined with Social Cognitive Theory in a peer-led intervention is effective to increase self-reported brushing frequency and improve oral hygiene status and OHRQoL among adolescents.",2022,"RESULTS


Brushing, flossing, and OHRQoL improved more in the experimental group than in the control group at the 6-month follow-up compared with baseline (p < .001).","['1184 students in 12 schools', 'Hong Kong Adolescents']","['peer-led theory-based oral health intervention, while the control group received booklets for oral health promotion', 'peer-led oral health intervention', 'Multi-Theory-Based Peer-Led Intervention', 'OHRQoL']","['oral hygiene status and OHRQoL', 'oral health', 'Oral Health', 'mean gain score difference', 'oral health-related quality of life (OHRQoL', 'mean gain score of brushing frequency, plaque index, caries status, and OHRQoL', 'Brushing, flossing, and OHRQoL', 'dental plaque accumulation and caries status']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0150290', 'cui_str': 'Oral health promotion'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C4082459', 'cui_str': 'Oral hygiene status'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}]",12.0,0.129019,"RESULTS


Brushing, flossing, and OHRQoL improved more in the experimental group than in the control group at the 6-month follow-up compared with baseline (p < .001).","[{'ForeName': 'Bilu', 'Initials': 'B', 'LastName': 'Xiang', 'Affiliation': 'Department of Paediatric Dentistry, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Colman P J', 'Initials': 'CPJ', 'LastName': 'McGrath', 'Affiliation': 'Department of Dental Public Health, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Hai Ming', 'Initials': 'HM', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatric Dentistry, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR. Electronic address: wonghmg@hku.hk.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2021.08.001']
923,34521108,A randomized phase 2 trial of idiotype vaccination and adoptive autologous T-cell transfer in patients with multiple myeloma.,"We hypothesized that combining adoptively transferred autologous T cells with a cancer vaccine strategy would enhance therapeutic efficacy by adding antimyeloma idiotype (Id)-keyhole limpet hemocyanin (KLH) vaccine to vaccine-specific costimulated T cells. In this randomized phase 2 trial, patients received either control (KLH only) or Id-KLH vaccine, autologous transplantation, vaccine-specific costimulated T cells expanded ex vivo, and 2 booster doses of assigned vaccine. In 36 patients (KLH, n = 20; Id-KLH, n = 16), no dose-limiting toxicity was seen. At last evaluation, 6 (30%) and 8 patients (50%) had achieved complete remission in KLH-only and Id-KLH arms, respectively (P = .22), and no difference in 3-year progression-free survival was observed (59% and 56%, respectively; P = .32). In a 594 Nanostring nCounter gene panel analyzed for immune reconstitution (IR), compared with patients receiving KLH only, there was a greater change in IR genes in T cells in those receiving Id-KLH relative to baseline. Specifically, upregulation of genes associated with activation, effector function induction, and memory CD8+ T-cell generation after Id-KLH but not after KLH control vaccination was observed. Similarly, in responding patients across both arms, upregulation of genes associated with T-cell activation was seen. At baseline, all patients had greater expression of CD8+ T-cell exhaustion markers. These changes were associated with functional Id-specific immune responses in a subset of patients receiving Id-KLH. In conclusion, in this combination immunotherapy approach, we observed significantly more robust IR in CD4+ and CD8+ T cells in the Id-KLH arm, supporting further investigation of vaccine and adoptive immunotherapy strategies. This trial was registered at www.clinicaltrials.gov as #NCT01426828.",2022,"Specifically, upregulation of genes associated with activation, induction of effector function, and generation of memory CD8+ T cells after Id-KLH, but not after KLH control vaccination, was observed.",['Multiple Myeloma patients'],"['control (KLH only) or Id-KLH vaccine, an auto-transplant, vaccine-specific co-stimulated T-cells expanded ex-vivo, and two booster doses of the assigned vaccine', 'Idiotype Vaccination and Adoptive Autologous T-Cell Transfer']","['no dose-limiting toxicity', 'upregulation of genes associated with activation, induction of effector function, and generation of memory CD8+ T cells', 'upregulation of genes associated with T-cell activation', 'expression of CD8+ T-cell exhaustion markers', 'functional Id-specific immune responses', 'robust IR in CD4+ and CD8+ T cells', 'therapeutic efficacy', '3-year progression-free survival', 'complete remission']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0064332', 'cui_str': 'Keyhole-limpet hemocyanin'}, {'cui': 'C0021013', 'cui_str': 'Immunoglobulin idiotype'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C4505207', 'cui_str': 'Immune Regeneration'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",,0.076151,"Specifically, upregulation of genes associated with activation, induction of effector function, and generation of memory CD8+ T cells after Id-KLH, but not after KLH control vaccination, was observed.","[{'ForeName': 'Muzaffar H', 'Initials': 'MH', 'LastName': 'Qazilbash', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Neeraj Y', 'Initials': 'NY', 'LastName': 'Saini', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Soung-Chul', 'Initials': 'SC', 'LastName': 'Cha', 'Affiliation': 'Toni Stephenson Lymphoma Center, Hematologic Malignancies Research Institute, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, CA.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Toni Stephenson Lymphoma Center, Hematologic Malignancies Research Institute, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, CA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Stadtmauer', 'Affiliation': 'Center for Cellular Immunotherapies and the Parker Institute for Cancer Immunotherapy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Veerabhadran', 'Initials': 'V', 'LastName': 'Baladandayuthapani', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX; and.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX; and.'}, {'ForeName': 'Beryl', 'Initials': 'B', 'LastName': 'Tross', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Medhavi', 'Initials': 'M', 'LastName': 'Honhar', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Sheetal S', 'Initials': 'SS', 'LastName': 'Rao', 'Affiliation': 'Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Kunhwa', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Popescu', 'Affiliation': 'Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Szymon', 'Initials': 'S', 'LastName': 'Szymura', 'Affiliation': 'Toni Stephenson Lymphoma Center, Hematologic Malignancies Research Institute, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, CA.'}, {'ForeName': 'Tiantian', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Toni Stephenson Lymphoma Center, Hematologic Malignancies Research Institute, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, CA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Toni Stephenson Lymphoma Center, Hematologic Malignancies Research Institute, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, CA.'}, {'ForeName': 'Qaiser', 'Initials': 'Q', 'LastName': 'Bashir', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Shpall', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Levine', 'Affiliation': 'Center for Cellular Immunotherapies and the Parker Institute for Cancer Immunotherapy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Naseem', 'Initials': 'N', 'LastName': 'Kerr', 'Affiliation': 'Center for Cellular Immunotherapies and the Parker Institute for Cancer Immunotherapy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Garfall', 'Affiliation': 'Center for Cellular Immunotherapies and the Parker Institute for Cancer Immunotherapy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Center for Cellular Immunotherapies and the Parker Institute for Cancer Immunotherapy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Dan T', 'Initials': 'DT', 'LastName': 'Vogl', 'Affiliation': 'Center for Cellular Immunotherapies and the Parker Institute for Cancer Immunotherapy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dengel', 'Affiliation': 'Center for Cellular Immunotherapies and the Parker Institute for Cancer Immunotherapy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Carl H', 'Initials': 'CH', 'LastName': 'June', 'Affiliation': 'Center for Cellular Immunotherapies and the Parker Institute for Cancer Immunotherapy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Champlin', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Kwak', 'Affiliation': 'Toni Stephenson Lymphoma Center, Hematologic Malignancies Research Institute, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, CA.'}]",Blood,['10.1182/blood.2020008493']
924,32888944,Enhancing the prediction of childhood asthma remission: Integrating clinical factors with microRNAs.,,2021,,[],[],[],[],[],[],,0.0594964,,"[{'ForeName': 'Alberta L', 'Initials': 'AL', 'LastName': 'Wang', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, Mass; Division of Allergy and Clinical Immunology, Brigham and Women's Hospital, Boston, Mass. Electronic address: awang@bwh.harvard.edu.""}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Alvin T', 'Initials': 'AT', 'LastName': 'Kho', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'McGeachie', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Kelan G', 'Initials': 'KG', 'LastName': 'Tantisira', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, Mass; Division of Pulmonary and Critical Care, Brigham and Women's Hospital, Boston, Mass.""}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.08.019']
925,34538263,Impact of vitamin C supplementation on placental DNA methylation changes related to maternal smoking: association with gene expression and respiratory outcomes.,"BACKGROUND


Maternal smoking during pregnancy (MSDP) affects development of multiple organ systems including the placenta, lung, brain, and vasculature. In particular, children exposed to MSDP show lifelong deficits in pulmonary function and increased risk of asthma and wheeze. Our laboratory has previously shown that vitamin C supplementation during pregnancy prevents some of the adverse effects of MSDP on offspring respiratory outcomes. Epigenetic modifications, including DNA methylation (DNAm), are a likely link between in utero exposures and adverse health outcomes, and MSDP has previously been associated with DNAm changes in blood, placenta, and buccal epithelium. Analysis of placental DNAm may reveal critical targets of MSDP and vitamin C relevant to respiratory health outcomes.
RESULTS


DNAm was measured in placentas obtained from 72 smokers enrolled in the VCSIP RCT: NCT03203603 (37 supplemented with vitamin C, 35 with placebo) and 24 never-smokers for reference. Methylation at one CpG, cg20790161, reached Bonferroni significance and was hypomethylated in vitamin C supplemented smokers versus placebo. Analysis of spatially related CpGs identified 93 candidate differentially methylated regions (DMRs) between treatment groups, including loci known to be associated with lung function, oxidative stress, fetal development and growth, and angiogenesis. Overlap of nominally significant differentially methylated CpGs (DMCs) in never-smokers versus placebo with nominally significant DMCs in vitamin C versus placebo identified 9059 candidate ""restored CpGs"" for association with placental transcript expression and respiratory outcomes. Methylation at 274 restored candidate CpG sites was associated with expression of 259 genes (FDR < 0.05). We further identified candidate CpGs associated with infant lung function (34 CpGs) and composite wheeze (1 CpG) at 12 months of age (FDR < 0.05). Increased methylation in the DIP2C, APOH/PRKCA, and additional candidate gene regions was associated with improved lung function and decreased wheeze in offspring of vitamin C-treated smokers.
CONCLUSIONS


Vitamin C supplementation to pregnant smokers ameliorates changes associated with maternal smoking in placental DNA methylation and gene expression in pathways potentially linked to improved placental function and offspring respiratory health. Further work is necessary to validate candidate loci and elucidate the causal pathway between placental methylation changes and outcomes of offspring exposed to MSDP. Clinical trial registration ClinicalTrials.gov, NCT01723696. Registered November 6, 2012. https://clinicaltrials.gov/ct2/show/record/NCT01723696 .",2021,"Methylation at one CpG, cg20790161, reached Bonferroni significance and was hypomethylated in vitamin C supplemented smokers versus placebo.","['pregnant smokers', '72 smokers enrolled in the VCSIP RCT']","['placebo', 'Vitamin C supplementation', 'vitamin C, 35 with placebo', 'vitamin C supplementation']","['placental DNA methylation changes related to maternal smoking', 'lung function', 'lung function, oxidative stress, fetal development and growth, and angiogenesis', 'risk of asthma and wheeze']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0015928', 'cui_str': 'Fetal Development'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}]",,0.523069,"Methylation at one CpG, cg20790161, reached Bonferroni significance and was hypomethylated in vitamin C supplemented smokers versus placebo.","[{'ForeName': 'Lyndsey E', 'Initials': 'LE', 'LastName': 'Shorey-Kendrick', 'Affiliation': 'Division of Neuroscience, Oregon National Primate Research Center, Oregon Health and Science University, 505 NW 185th Ave, Beaverton, OR, 97006, USA. shorey@ohsu.edu.'}, {'ForeName': 'Cindy T', 'Initials': 'CT', 'LastName': 'McEvoy', 'Affiliation': 'Department of Pediatrics, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': ""O'Sullivan"", 'Affiliation': 'Division of Neuroscience, Oregon National Primate Research Center, Oregon Health and Science University, 505 NW 185th Ave, Beaverton, OR, 97006, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Milner', 'Affiliation': 'Department of Pediatrics, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Vuylsteke', 'Affiliation': 'Department of Pediatrics, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Tepper', 'Affiliation': 'Department of Pediatrics, Herman B Wells Center for Pediatric Research, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Haas', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Byung', 'Initials': 'B', 'LastName': 'Park', 'Affiliation': 'Biostatistics Shared Resources, Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Biostatistics Shared Resources, Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Vu', 'Affiliation': 'Department of Medical Informatics and Clinical Epidemiology, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Morris', 'Affiliation': 'Department of Medical Informatics and Clinical Epidemiology, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Eliot R', 'Initials': 'ER', 'LastName': 'Spindel', 'Affiliation': 'Division of Neuroscience, Oregon National Primate Research Center, Oregon Health and Science University, 505 NW 185th Ave, Beaverton, OR, 97006, USA.'}]",Clinical epigenetics,['10.1186/s13148-021-01161-y']
926,34529551,Improving Practices of Mental Health Professionals in Recommending More Physical Activity and Less Sedentary Behaviour to Their Clients: An Intervention Trial.,"We investigated the effects of increasing physical activity (PA) and reducing sedentary behaviour (SB) of mental health professionals on their attitudes towards and practices in recommending more PA and less SB to their clients. A 4-week pre-post intervention trial was conducted involving 17 mental health professionals. The participants who increased their own physical activity during the intervention increased the frequency of recommending more PA ( p  = 0.009) and less SB ( p  = 0.005) to their clients. A relatively simple, low-cost intervention, consisting of group behaviour change counselling, goal setting and positive feedback, may improve the practices of mental health professionals.Supplemental data for this article is available online at https://doi.org/10.1080/01612840.2021.1972189 .",2022,The participants who increased their own physical activity during the intervention increased the frequency of recommending more PA ( p  = 0.009) and less SB ( p  = 0.005) to their clients.,"['mental health professionals on their attitudes towards and practices in recommending more PA and less SB to their clients', '17 mental health professionals']",['physical activity (PA) and reducing sedentary behaviour (SB'],"['SB', 'frequency of recommending more PA', 'physical activity']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3875150', 'cui_str': 'Towards'}, {'cui': 'C0205172', 'cui_str': 'More'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",17.0,0.0222897,The participants who increased their own physical activity during the intervention increased the frequency of recommending more PA ( p  = 0.009) and less SB ( p  = 0.005) to their clients.,"[{'ForeName': 'Nipun', 'Initials': 'N', 'LastName': 'Shrestha', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Parker', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Danijel', 'Initials': 'D', 'LastName': 'Jurakic', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Stuart J H', 'Initials': 'SJH', 'LastName': 'Biddle', 'Affiliation': 'Physically Active Lifestyles Research Group (USQ-PALs), Centre for Health Research, University of Southern Queensland, Springfield Central, Australia.'}, {'ForeName': 'Zeljko', 'Initials': 'Z', 'LastName': 'Pedisic', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}]",Issues in mental health nursing,['10.1080/01612840.2021.1972189']
927,34535609,Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Efficacy Analysis of a Phase III Study Performed in Russia.,"INTRODUCTION


Allergic rhinitis (AR) is a disease which affects >24% of the population in Russia. Triamcinolone acetonide (TAA) is a corticosteroid used for treating AR. This post hoc analysis assesses the efficacy of intranasal TAA in improving perennial AR (PAR) symptom scores over 4 weeks.
METHODS


NASANIF (NCT03317015) was a double-blind, parallel-group, multicenter, prospective, non-inferiority, phase III clinical trial in which patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) over 4 weeks. Our post hoc analysis evaluates weekly change in PAR symptoms using the reflective Total Nasal Symptom Score (rTNSS), overall and for individual symptoms (sneezing, nasal itching, rhinorrhoea, and nasal obstruction). Proportion of patients and time to achieve a ≥50 or ≥75% reduction in rTNSS were assessed. For rTNSS endpoints, a linear mixed-model methodology was used; for time-to-event endpoints, cumulative incidence functions were estimated using the Kaplan-Meier method, in the per-protocol population.
RESULTS


Of 260 patients, 128 each completed the study and were randomized to receive TAA or FP. From baseline to week 4, the changes in total rTNSS were -7.78 (95% CI: -8.1701 to -7.3967; p < 0.001) and -7.52 (-7.9053 to -7.1320; p < 0.001) for TAA and FP, respectively. Individual symptoms improved significantly from baseline. The proportion of patients achieving ≥50 and ≥75% reductions in total rTNSS was 88.0 and 67.2%, respectively in the TAA group. No significant differences were observed between the TAA and FP in any analyses.
CONCLUSIONS


TAA produced effective and prolonged improvement of PAR symptoms over a 4-week treatment period.",2022,"This post hoc analysis assesses the efficacy of intranasal TAA in improving perennial AR (PAR) symptom scores over 4 weeks.
","['Perennial Allergic Rhinitis', '260 patients', 'patients with PAR were randomized ']","['intranasal TAA', 'TAA or FP', 'Triamcinolone Acetonide', 'TAA or fluticasone propionate (FP', 'Triamcinolone acetonide (TAA']","['PAR symptoms', 'PAR symptoms using the reflective Total Nasal Symptom Score (rTNSS), overall and for individual symptoms (sneezing, nasal itching, rhinorrhoea, and nasal obstruction', 'total rTNSS', 'perennial AR (PAR) symptom scores', 'Individual symptoms', 'TAA and FP']","[{'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037383', 'cui_str': 'Sneezing'}, {'cui': 'C0850060', 'cui_str': 'Nasal pruritus'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}]",260.0,0.118996,"This post hoc analysis assesses the efficacy of intranasal TAA in improving perennial AR (PAR) symptom scores over 4 weeks.
","[{'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Karaulov', 'Affiliation': 'Department of Clinical Immunology and Allergology of I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation.'}, {'ForeName': 'Natalia I', 'Initials': 'NI', 'LastName': 'Ilina', 'Affiliation': 'National Research Centre, Institute of Immunology Federal Medical-Biological Agency of Russia, Moscow, Russian Federation.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Shartanova', 'Affiliation': 'Medical Department, Sanofi Consumer Healthcare, Medical Affairs, Moscow, Russian Federation.'}, {'ForeName': 'Aleksandr', 'Initials': 'A', 'LastName': 'Maslakov', 'Affiliation': 'Medical Department, Sanofi Consumer Healthcare, Medical Affairs, Moscow, Russian Federation.'}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Lucio', 'Affiliation': 'Medical Department, Sanofi Consumer Healthcare, São Paulo, Brazil.'}]",International archives of allergy and immunology,['10.1159/000518754']
928,33949213,Metabolomic profiles are reflective of hypoxia-induced insulin resistance during exercise in healthy young adult males.,"Hypoxia-induced insulin resistance appears to suppress exogenous glucose oxidation during metabolically matched aerobic exercise during acute (<8 h) high-altitude (HA) exposure. However, a better understanding of this metabolic dysregulation is needed to identify interventions to mitigate these effects. The objective of this study was to determine if differences in metabolomic profiles during exercise at sea level (SL) and HA are reflective of hypoxia-induced insulin resistance. Native lowlanders ( n  = 8 males) consumed 145 g (1.8 g/min) of glucose while performing 80-min of metabolically matched treadmill exercise at SL (757 mmHg) and HA (460 mmHg) after 5-h exposure. Exogenous glucose oxidation and glucose turnover were determined using indirect calorimetry and dual tracer technique ([ 13 C]glucose and [6,6- 2 H 2 ]glucose). Metabolite profiles were analyzed in serum as change (Δ), calculated by subtracting postprandial/exercised state SL (ΔSL) and HA (ΔHA) from fasted, rested conditions at SL. Compared with SL, exogenous glucose oxidation, glucose rate of disappearance, and glucose metabolic clearance rate (MCR) were lower ( P  < 0.05) during exercise at HA. One hundred and eighteen metabolites differed between ΔSL and ΔHA ( P  < 0.05,  Q  <   0.10). Differences in metabolites indicated increased glycolysis, tricarboxylic acid cycle, amino acid catabolism, oxidative stress, and fatty acid storage, and decreased fatty acid mobilization for ΔHA. Branched-chain amino acids and oxidative stress metabolites, Δ3-methyl-2-oxobutyrate ( r  = -0.738) and Δγ-glutamylalanine ( r  = -0.810), were inversely associated ( P  < 0.05) with Δexogenous glucose oxidation. Δ3-Hydroxyisobutyrate ( r  = -0.762) and Δ2-hydroxybutyrate/2-hydroxyisobutyrate ( r  = -0.738) were inversely associated ( P  < 0.05) with glucose MCR. Coupling global metabolomics and glucose kinetic data suggest that the underlying cause for diminished exogenous glucose oxidative capacity during aerobic exercise is acute hypoxia-mediated peripheral insulin resistance.",2021,"Compared with SL, exogenous glucose oxidation, glucose rate of disappearance, and glucose metabolic clearance rate (MCR) were lower ( P  < 0.05) during exercise at HA.","['healthy young adult males', 'Native lowlanders ( n  = 8 males) consumed 145']","['Hypoxia-induced insulin resistance', 'glucose while performing 80-min of metabolically matched treadmill exercise at SL']","['exogenous glucose oxidation, glucose rate of disappearance, and glucose metabolic clearance rate (MCR', 'Δ3-Hydroxyisobutyrate', 'glycolysis, tricarboxylic acid cycle, amino acid catabolism, oxidative stress, and fatty acid storage, and decreased fatty acid mobilization for ΔHA', 'subtracting postprandial/exercised state SL (ΔSL) and HA (ΔHA', 'Metabolite profiles', 'Exogenous glucose oxidation and glucose turnover']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C4517577', 'cui_str': '145'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C3254418', 'cui_str': 'NR3C2 protein, human'}, {'cui': 'C0017952', 'cui_str': 'Glycolysis'}, {'cui': 'C0008858', 'cui_str': 'Krebs cycle pathway'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0543484', 'cui_str': 'catabolism'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C1719767', 'cui_str': 'Subtract - dosing instruction fragment'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1290923', 'cui_str': 'Exercise state'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}]",,0.0480915,"Compared with SL, exogenous glucose oxidation, glucose rate of disappearance, and glucose metabolic clearance rate (MCR) were lower ( P  < 0.05) during exercise at HA.","[{'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Margolis', 'Affiliation': 'United States Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Karl', 'Affiliation': 'United States Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Marques A', 'Initials': 'MA', 'LastName': 'Wilson', 'Affiliation': 'United States Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Coleman', 'Affiliation': 'United States Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Arny A', 'Initials': 'AA', 'LastName': 'Ferrando', 'Affiliation': 'Department of Geriatrics, Center for Translational Research in Aging and Longevity, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Young', 'Affiliation': 'United States Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Stefan M', 'Initials': 'SM', 'LastName': 'Pasiakos', 'Affiliation': 'United States Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00076.2021']
929,34518408,Factor Analysis of the Short-Form Cohen-Mansfield Agitation Inventory and the Measurement Invariance by Gender.,"BACKGROUND AND PURPOSE


The Cohen-Mansfield Agitation Inventory (CMAI) is a widely used measure of agitation. The purpose of this study was to test the internal consistency, reliability, and validity of short-form CMAI in a sample of nursing home residents with cognitive impairment and examine if it is invariant across gender.
METHODS


This study utilized baseline data from a randomized trial including 553 residents from 55 nursing homes. Data was analyzed using structural equation modeling.
RESULTS


Confirmatory factory analysis supported the three-factor structure including  aggressive  (α = .794),  physically nonaggressive  (α = .617), and  verbally agitated  (α = .718) behaviors. Invariance testing confirmed that the shortened measure is invariant across gender.
CONCLUSIONS


Findings provide validity evidence of short-form CMAI to assess agitation and gender differences in agitation in nursing home population.",2021,"RESULTS


Confirmatory factory analysis supported the three-factor structure including  aggressive  ( α  = .794),  physically nonaggressive  ( α  = .617), and  verbally agitated  ( α  = .718) behaviors.",['553 residents from 55 nursing homes'],['short-form CMAI'],[],"[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",[],553.0,0.0486145,"RESULTS


Confirmatory factory analysis supported the three-factor structure including  aggressive  ( α  = .794),  physically nonaggressive  ( α  = .617), and  verbally agitated  ( α  = .718) behaviors.","[{'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Paudel', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, Maryland paudelanju41@gmail.com.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Resnick', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Galik', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, Maryland.'}]",Journal of nursing measurement,['10.1891/JNM-D-20-00031']
930,34518377,The Bihormonal Bionic Pancreas Improves Glycemic Control in Individuals With Hyperinsulinism and Postpancreatectomy Diabetes: A Pilot Study.,"OBJECTIVE


To determine whether the bihormonal bionic pancreas (BHBP) improves glycemic control and reduces hypoglycemia in individuals with congenital hyperinsulinism (HI) and postpancreatectomy diabetes (PPD) compared with usual care (UC).
RESEARCH DESIGN AND METHODS


Ten subjects with HI and PPD completed this open-label, crossover pilot study. Coprimary outcomes were mean glucose concentration and time with continuous glucose monitoring (CGM) glucose concentration <3.3 mmol/L.
RESULTS


Mean (SD) CGM glucose concentration was 8.3 (0.7) mmol/L in the BHBP period versus 9 (1.8) mmol/L in the UC period ( P  = 0.13). Mean (SD) time with CGM glucose concentration <3.3 mmol/L was 0% (0.002) in the BHBP period vs. 1.3% (0.018) in the UC period ( P  = 0.11).
CONCLUSIONS


Relative to UC, the BHBP resulted in comparable glycemic control in our population.",2021,L was 0% (0.002) in the BHBP period vs. 1.3% (0.018) in the UC period (,"['Ten subjects with HI and PPD completed this open-label, crossover pilot study', 'individuals with congenital hyperinsulinism (HI) and postpancreatectomy diabetes (PPD) compared with usual care (UC', 'Individuals With Hyperinsulinism and Postpancreatectomy Diabetes']",['bihormonal bionic pancreas (BHBP'],"['mean glucose concentration and time with continuous glucose monitoring (CGM) glucose concentration', 'Mean (SD) CGM glucose concentration', 'Mean (SD) time with CGM glucose concentration', 'hypoglycemia']","[{'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3888018', 'cui_str': 'Congenital hyperinsulinism'}]","[{'cui': 'C0005549', 'cui_str': 'Bionics'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0202048', 'cui_str': 'Glucose measurement by monitoring device'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",10.0,0.019085,L was 0% (0.002) in the BHBP period vs. 1.3% (0.018) in the UC period (,"[{'ForeName': 'Arpana', 'Initials': 'A', 'LastName': 'Rayannavar', 'Affiliation': ""Division of Endocrinology and Diabetes, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Mitteer', 'Affiliation': ""Division of Endocrinology and Diabetes, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Balliro', 'Affiliation': 'Diabetes Research Center and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Firas H', 'Initials': 'FH', 'LastName': 'El-Khatib', 'Affiliation': 'Department of Biomedical Engineering, Boston University, Boston, MA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Lord', 'Affiliation': ""Division of Endocrinology and Diabetes, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Colin P', 'Initials': 'CP', 'LastName': 'Hawkes', 'Affiliation': ""Division of Endocrinology and Diabetes, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Lance S', 'Initials': 'LS', 'LastName': 'Ballester', 'Affiliation': ""Biostatistics and Data Management Core, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Damiano', 'Affiliation': 'Department of Biomedical Engineering, Boston University, Boston, MA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Russell', 'Affiliation': 'Diabetes Research Center and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Diva D', 'Initials': 'DD', 'LastName': 'De León', 'Affiliation': ""Division of Endocrinology and Diabetes, The Children's Hospital of Philadelphia, Philadelphia, PA deleon@chop.edu.""}]",Diabetes care,['10.2337/dc21-0416']
931,34994838,Assessment of Intraparenchymal Injection of 1% Patent Blue Dye in the Upper Outer Quadrant of the Breast to Identify Sentinel Lymph Node in Early Retro-Areolar Breast Cancer in Women: A Tertiary Centre Experience in Egypt.,"BACKGROUND


Sentinel lymph node biopsy is the gold standard for axillary assessment of patients with clinically node negative breast cancer. The current internationally accepted methods comprise of the usage of either a radioactive tracer, vital stains or the combination of both. However, in developing countries radioactive tracer is not widely used due to its high cost and limited availability. In addition, the classic retro-areolar blue dye injection has a high failure rate.
OBJECTIVE


Our study aimed to assess the efficacy of patent blue dye injection in the upper outer quadrant of the breast after validation by concurrent usage of radioactive nanocolloid, in comparison with the classic retro-areolar injection in identifying the sentinel node.
METHODS


A randomized control study involving 279 patients randomly divided into two groups. In group A lateral injection of 1% patent blue dye (validated by radioactive nanocolloid) was used, while subdermal patent blue dye injection in the retro-areolar space was performed in group B.
RESULTS


The new technique showed the promising results with lower failure rate (3.4%) in comparison with the classic retro-areolar patent blue injection (13.7%).
CONCLUSIONS


The lateral injection technique can be result in comparable results to the combination technique with the added benefit of being widely available and a cheaper option especially in developing countries.",2022,"The new technique showed the promising results with lower failure rate (3.4%) in comparison with the classic retro-areolar patent blue injection (13.7%).
","['279 patients randomly divided into two groups', 'Areolar Breast Cancer in Women', 'patients with clinically node negative breast cancer', 'A Tertiary Centre Experience in Egypt']","['Intraparenchymal Injection of 1% Patent Blue Dye', 'lateral injection of 1% patent blue dye (validated by radioactive nanocolloid', 'patent blue dye injection']",['failure rate'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0034553', 'cui_str': 'Radioactivity'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}]",279.0,0.052734,"The new technique showed the promising results with lower failure rate (3.4%) in comparison with the classic retro-areolar patent blue injection (13.7%).
","[{'ForeName': 'Mina M B', 'Initials': 'MMB', 'LastName': 'Fouad', 'Affiliation': 'General Surgery Department, Kasr Al Aini teaching hospital, Cairo University, 18 A, North road, Nottingham, NG116AD, UK. mina.fouad89@gmail.com.'}, {'ForeName': 'Kirilos', 'Initials': 'K', 'LastName': 'Fouad', 'Affiliation': 'South Valley University, Qena, Egypt.'}, {'ForeName': 'Sandy M N', 'Initials': 'SMN', 'LastName': 'Ibraheim', 'Affiliation': 'Radiology department, Kasr Al Aini Teaching Hospital, Cairo University, Nottingham, UK.'}]",World journal of surgery,['10.1007/s00268-021-06421-9']
932,34533841,The antimuscarinic agent biperiden selectively impairs recognition of abstract figures without affecting the processing of non-words.,"OBJECTIVES


The present study investigated the effects of biperiden, a muscarinic type 1 antagonist, on the recognition performance of pre-experimentally unfamiliar abstract figures and non-words in healthy young volunteers. The aim was to examine whether 4 mg biperiden could model the recognition memory impairment seen in healthy aging.
METHODS


A double-blind, placebo-controlled, two-way crossover study was conducted. We used a three-phase (deep memorization, shallow memorization, and recognition) old/new discrimination paradigm in which memory strength was manipulated. Strong memories were induced by deep encoding and repetition. Deep encoding was encouraged by redrawing the abstract figures and mentioning existing rhyme words for the non-words (semantic processing). Weak memories were created by merely instructing the participants to study the stimuli (shallow memorization).
RESULTS


Biperiden impaired recognition accuracy and prolonged reaction times of the drawn and the studied abstract figures. However, participants were biased towards ""old"" responses in the placebo condition. The recognition of the new abstract figures was unaffected by the drug. Biperiden did not affect the recognition of the non-words.
CONCLUSIONS


Although biperiden may model age-related deficits in episodic memory, the current findings indicate that biperiden does not mimic age-related deficits in recognition performance.",2022,Biperiden did not affect the recognition of,"['healthy aging', 'healthy young volunteers']",['placebo'],['recognition accuracy and prolonged reaction times'],"[{'cui': 'C2963171', 'cui_str': 'Healthy Ageing'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0360117,Biperiden did not affect the recognition of,"[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Toth', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, The Netherlands.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Sambeth', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, The Netherlands.'}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Blokland', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, The Netherlands.'}]",Human psychopharmacology,['10.1002/hup.2819']
933,34536050,Intradialytic periodized exercise improves cardiopulmonary fitness and respiratory function: A randomized controlled trial.,"BACKGROUND


Chronic kidney disease (CKD) is a factor that predisposes to gradual physical deconditioning from its early stages leading to cardiorespiratory fitness and musculoskeletal system impairment. We evaluated the effects of combined and periodized intradialytic exercise training on cardiopulmonary fitness and respiratory function in HD subjects.
METHODS


A randomized controlled trial with HD subjects was allocated into two groups: exercise group (EXG) and usual care group (UCG). EXG performed a 12-week combined and periodized intradialytic training. UCG maintained the HD routine.
RESULTS


Thirty-nine HD subjects were analyzed (EXG = 20; UCG = 19). The EXG in comparison with the UCG showed improvements in peak oxygen consumption (Δ3.1[0.4-5.5] vs. -0.2[-2.0-1.5] ml/kg/min; p = 0.003), forced expiratory volume in the first second (Δ0.1[-0.0-0.1] vs. -0.0[-0.1-0.0] L; p = 0.022), forced vital capacity (Δ0.1[0.0-0.2] vs. -0.1[-0.2-0.0] L; p = 0.005), peak expiratory flow (Δ0.4[-0.7-1.2] vs. -0.1[-0.5-0.2] L; p = 0.046), and maximal inspiratory pressure (Δ7.35[-8.5-17.5] vs. -4.0[-18.0-12.0] cmH 2  O; p = 0.028). The EXG, different from the UCG, did not worsen the maximal expiratory pressure (Δ0.1[-8.8-7.5] vs. -2.5[-15.0-9.0] cmH 2  O; p = 0.036). Besides, EXG showed a significant improvement in quadriceps strength (32.05 ± 10.61 vs. 33.35 ± 11.62 kg; p = 0.042).
CONCLUSIONS


The combined and periodized intradialytic exercise training improved cardiopulmonary fitness, respiratory function, inspiratory muscle strength, and quadriceps strength, beyond maintaining the expiratory muscle strength in HD subjects.",2022,"Besides, EXG showed a significant improvement in quadriceps strength (32.05 ± 10.61 vs. 33.35 ± 11.62 kg; p = 0.042).
","['Chronic kidney disease (CKD', 'Thirty-nine HD subjects', 'HD subjects']","['EXG', 'exercise group (EXG) and usual care group (UCG', 'combined and periodized intradialytic exercise training', 'periodized intradialytic training', 'Intradialytic periodized exercise', 'periodized intradialytic exercise training']","['cardiopulmonary fitness and respiratory function', 'forced expiratory volume', 'maximal inspiratory pressure', 'quadriceps strength', 'peak expiratory flow', 'forced vital capacity', 'cardiopulmonary fitness, respiratory function, inspiratory muscle strength, and quadriceps strength, beyond maintaining the expiratory muscle strength', 'maximal expiratory pressure', 'peak oxygen consumption']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C3816447', 'cui_str': '39'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4082175', 'cui_str': 'Maximum Expiratory Pressure'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",39.0,0.0270809,"Besides, EXG showed a significant improvement in quadriceps strength (32.05 ± 10.61 vs. 33.35 ± 11.62 kg; p = 0.042).
","[{'ForeName': 'Francini Porcher', 'Initials': 'FP', 'LastName': 'Andrade', 'Affiliation': 'Ciências Pneumológicas Post-Graduation Program, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Gabrielle Costa', 'Initials': 'GC', 'LastName': 'Borba', 'Affiliation': 'Ciências Pneumológicas Post-Graduation Program, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Kacylen Costa', 'Initials': 'KC', 'LastName': 'da Silva', 'Affiliation': 'Ciências Pneumológicas Post-Graduation Program, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Tatiane de Souza', 'Initials': 'TS', 'LastName': 'Ferreira', 'Affiliation': 'Ciências Pneumológicas Post-Graduation Program, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Samantha Gonçalves', 'Initials': 'SG', 'LastName': 'de Oliveira', 'Affiliation': 'Division of Nephrology, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Verônica Verleine Hörbe', 'Initials': 'VVH', 'LastName': 'Antunes', 'Affiliation': 'Division of Nephrology, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Francisco Veríssimo', 'Initials': 'FV', 'LastName': 'Veronese', 'Affiliation': 'Division of Nephrology, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Paula Maria Eidt', 'Initials': 'PME', 'LastName': 'Rovedder', 'Affiliation': 'Ciências Pneumológicas Post-Graduation Program, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}]",Seminars in dialysis,['10.1111/sdi.13020']
934,34515149,Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Analysis of Quality of Life during a Phase III Study.,"INTRODUCTION


Allergic rhinitis (AR) is a disease that affects ≤24% of people in Russia, significantly impairing quality of life (QoL). Intranasal corticosteroids, such as triamcinolone acetonide (TAA), are considered effective drugs for treatment. A post hoc analysis of data (phase III NASANIF trial) examined weekly QoL changes in patients receiving TAA for the treatment of perennial AR (PAR).
METHODS


NASANIF (NCT03317015) was a double-blind, parallel group, multicenter, prospective, noninferiority, phase III clinical trial. Patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) for 4 weeks. Here, a post hoc analysis measures QoL using a shortened Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ). Differences in miniRQLQ score were evaluated using a mixed linear model and descriptive statistics. A subgroup analysis was performed in patients with a previous diagnosis of allergic conjunctivitis.
RESULTS


Of 260 patients eligible for randomization, 128 each completed treatment with TAA or FP. Overall and individual domain scores progressively improved and were significantly different versus baseline at week 4 in both treatment groups: LS mean difference TAA: -30.92 (95% CI [-33.01 to -28.83]), p < 0.001, and FP: -31.13 (-33.23 to -29.04), p < 0.001. In both arms of the subgroup, there was a significant reduction in eye symptoms. There was no significant difference between the TAA and FP treatment groups in any analyses.
CONCLUSIONS


TAA is effective in improving overall and individual domains of QoL in patients with PAR, over 4 weeks. Patients with a previous diagnosis of allergic conjunctivitis experienced significant improvements in QoL related to the resolution of these symptoms.",2022,Overall and individual domain scores progressively improved and were significantly different versus baseline at week 4 in both treatment groups:,"['260 patients eligible for randomization, 128 each completed treatment with TAA or FP', 'patients receiving TAA for the treatment of perennial AR (PAR', 'Patients with a previous diagnosis of allergic conjunctivitis', 'Patients with PAR', 'Perennial Allergic Rhinitis', 'patients with a previous diagnosis of allergic conjunctivitis']","['Triamcinolone Acetonide', 'triamcinolone acetonide (TAA', 'TAA or fluticasone propionate (FP', 'TAA', 'Intranasal corticosteroids']","['QoL', 'miniRQLQ score', 'Quality of Life', 'quality of life (QoL', 'Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ', 'eye symptoms', 'Overall and individual domain scores']","[{'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}, {'cui': 'C0009766', 'cui_str': 'Allergic conjunctivitis'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0586406', 'cui_str': 'Eye symptom'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",260.0,0.100531,Overall and individual domain scores progressively improved and were significantly different versus baseline at week 4 in both treatment groups:,"[{'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Karaulov', 'Affiliation': 'Department of Clinical Immunology and Allergology, I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Nenasheva', 'Affiliation': 'Department of Immunology and Allergology, Russian Medical Academy for Continued Professional Education, Moscow, Russian Federation.'}, {'ForeName': 'Yury', 'Initials': 'Y', 'LastName': 'Smolkin', 'Affiliation': 'Department of Clinical Immunology and Allergology, Research and Clinical Center for Allergy and Clinical Immunology, Moscow, Russian Federation.'}, {'ForeName': 'Aleksandr', 'Initials': 'A', 'LastName': 'Maslakov', 'Affiliation': 'Medical Department, Sanofi Consumer Healthcare, Moscow, Russian Federation.'}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Lucio', 'Affiliation': 'Medical Department, Sanofi Consumer Healthcare, São Paulo, Brazil.'}]",International archives of allergy and immunology,['10.1159/000518753']
935,34516759,Capecitabine Versus Active Monitoring in Stable or Responding Metastatic Colorectal Cancer After 16 Weeks of First-Line Therapy: Results of the Randomized FOCUS4-N Trial.,"PURPOSE


Despite extensive randomized evidence supporting the use of treatment breaks in metastatic colorectal cancer (mCRC), they are not universally offered to patients despite improvements in quality of life without detriment to overall survival (OS). FOCUS4-N was set up to explore the impact of oral maintenance therapy in patients who are responding to first-line therapy.
METHODS


FOCUS4 was a molecularly stratified trial program that registered patients with newly diagnosed mCRC. The FOCUS4-N trial was offered to patients in whom a targeted subtrial was unavailable or biomarker tests failed. Patients were randomly assigned using a 1:1 ratio between maintenance capecitabine and active monitoring (AM). The primary outcome was progression-free survival (PFS) with secondary outcomes including OS toxicity and tolerability.
RESULTS


Between March 2014 and March 2020, 254 patients were randomly assigned (127 to capecitabine and 127 to AM) across 88 UK sites. Baseline characteristics were balanced. There was strong evidence of efficacy for PFS (hazard ratio = 0.40; 95% CI, 0.21 to 0.75;  P  < .0001), but no significant improvement in OS (hazard ratio, 0.93; 95% CI, 0.69 to 1.27;  P  = .66) was observed. Compliance with treatment was good, and toxicity from capecitabine versus AM was as expected with grade ≥ 2 fatigue (25%  v  12%), diarrhea (23%  v  13%), and hand-foot syndrome (26%  v  3%). Quality of life showed little difference between the groups.
CONCLUSION


Despite strong evidence of disease control with maintenance therapy, OS remains unaffected and FOCUS4-N provides additional evidence to support the use of treatment breaks as safe management alternatives for patients who are stable or responding to first-line treatment for mCRC. Capecitabine without bevacizumab may be used to extend PFS in the interval after 16 weeks of first-line therapy.",2021,"There was strong evidence of efficacy for PFS (hazard ratio = 0.40; 95% CI, 0.21 to 0.75;  P  < .0001), but no significant improvement in OS (hazard ratio, 0.93; 95% CI, 0.69 to 1.27;  P  = .66) was observed.","['Stable or Responding Metastatic Colorectal Cancer', 'patients who are stable or responding to first-line treatment for mCRC', 'Between March 2014 and March 2020', 'registered patients with newly diagnosed mCRC', 'metastatic colorectal cancer (mCRC', 'patients who are responding to first-line therapy', '254 patients were randomly assigned (127 to']","['Capecitabine', 'maintenance capecitabine and active monitoring (AM', 'FOCUS4-N', 'maintenance therapy', 'FOCUS4', 'capecitabine', 'Capecitabine without bevacizumab']","['Quality of life', 'progression-free survival (PFS', 'toxicity', 'OS toxicity and tolerability', 'diarrhea', 'OS']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1531698', 'cui_str': 'Active monitoring'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",254.0,0.138851,"There was strong evidence of efficacy for PFS (hazard ratio = 0.40; 95% CI, 0.21 to 0.75;  P  < .0001), but no significant improvement in OS (hazard ratio, 0.93; 95% CI, 0.69 to 1.27;  P  = .66) was observed.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Adams', 'Affiliation': 'Centre for Trials Research Cardiff University and Velindre NHS Trust, Cardiff, United Kingdom.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Fisher', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': 'University of Glasgow and Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Jenny F', 'Initials': 'JF', 'LastName': 'Seligmann', 'Affiliation': 'Leeds Institute of Medical Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Seymour', 'Affiliation': 'Leeds Institute of Medical Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Yates', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Richman', 'Affiliation': 'Leeds Institute of Medical Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Quirke', 'Affiliation': 'Leeds Institute of Medical Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Butler', 'Affiliation': 'Bristol Genetics Laboratory, Bristol, United Kingdom.'}, {'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Brown', 'Affiliation': 'Western General Hospital, Edinburgh, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Collinson', 'Affiliation': 'Leeds Institute of Medical Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Cancer Institute, Bristol, United Kingdom.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital London, London, United Kingdom.'}, {'ForeName': 'Kai-Keen', 'Initials': 'KK', 'LastName': 'Shiu', 'Affiliation': 'University College Hospital London, London, United Kingdom.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Middleton', 'Affiliation': 'University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Samuel', 'Affiliation': 'Aberdeen Royal Infirmary, Aberdeen, United Kingdom.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Wilson', 'Affiliation': 'University of Glasgow and Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Louise C', 'Initials': 'LC', 'LastName': 'Brown', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Maughan', 'Affiliation': 'MRC Oxford Institute for Radiation Oncology, Department of Oncology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.01436']
936,34518072,"Design and rationale of the EVOCATION trial: A prospective, randomized, exploratory study comparing the effect of evolocumab on coronary microvascular function after percutaneous coronary intervention in patients with stable coronary artery disease.","Percutaneous coronary intervention (PCI) is a standard treatment in patients with stable coronary artery disease (CAD); however, periprocedural myocardial infarction (PMI) remains a common complication of PCI. Aggressive lipid-lowering therapy with statin has shown to reduce the incidence of PMI by preventing coronary microvascular dysfunction. It is unclear whether evolocumab, a potent lipid-lowering agent, could diminish microvascular damage after PCI. The EVOCATION trial (jRCTs051180022) is a multicenter, randomized, open-label, active-controlled, parallel-group, exploratory, investigator-initiated clinical study to evaluate whether pretreatment with evolocumab could decrease the index of microvascular resistance (IMR) after PCI in patients with stable CAD. This study population consists of 100 patients with stable CAD who will undergo PCI and have high low-density lipoprotein cholesterol levels despite administration of maximum tolerated dose of statins for at least 2 weeks. Eligible patients are randomized in a 1:1 ratio to receive either evolocumab 140 mg every 2 weeks in addition to standard of care treatment or standard of care treatment only for 2-6 weeks before PCI. The primary endpoint is IMR after PCI. The EVOCATION trial will evaluate whether pretreatment with evolocumab reduces periprocedural microvascular damage in patients with stable CAD undergoing PCI.",2022,"The EVOCATION trial (jRCTs051180022) is a multicenter, randomized, open-label, active-controlled, parallel-group, exploratory, investigator-initiated clinical study to evaluate whether pretreatment with evolocumab could decrease the index of microvascular resistance (IMR) after PCI in patients with stable CAD.","['patients with stable coronary artery disease', 'Eligible patients', '100 patients with stable CAD who will undergo PCI and have high low-density lipoprotein cholesterol levels despite administration of maximum tolerated dose of statins for at least 2 weeks', 'patients with stable coronary artery disease (CAD', 'patients with stable CAD undergoing PCI', 'patients with stable CAD']","['Percutaneous coronary intervention (PCI', 'evolocumab', 'percutaneous coronary intervention', 'evolocumab 140 mg every 2 weeks in addition to standard of care treatment or standard of care treatment only for 2-6 weeks before PCI']","['periprocedural microvascular damage', 'coronary microvascular function', 'index of microvascular resistance (IMR', 'IMR after PCI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",100.0,0.0283166,"The EVOCATION trial (jRCTs051180022) is a multicenter, randomized, open-label, active-controlled, parallel-group, exploratory, investigator-initiated clinical study to evaluate whether pretreatment with evolocumab could decrease the index of microvascular resistance (IMR) after PCI in patients with stable CAD.","[{'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Asakura', 'Affiliation': 'Department of Cardiovascular and Renal Medicine, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hibi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Shimizu', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Fujii', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Suwa', 'Affiliation': 'Department of Cardiology, Juntendo University Shizuoka Hospital, Shizuoka, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Okumura', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Mano', 'Affiliation': 'Cardiovascular Center, Kansai Rosai Hospital, Hyogo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Igeta', 'Affiliation': 'Department of Biostatistics, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Rika', 'Initials': 'R', 'LastName': 'Okamoto', 'Affiliation': 'Center for Clinical Research and Education, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Ishihara', 'Affiliation': 'Department of Cardiovascular and Renal Medicine, Hyogo College of Medicine, Hyogo, Japan. Electronic address: ma-ishihara@hyo-med.ac.jp.'}]",Journal of cardiology,['10.1016/j.jjcc.2021.08.024']
937,34520230,Hepatectomy Followed by mFOLFOX6 Versus Hepatectomy Alone for Liver-Only Metastatic Colorectal Cancer (JCOG0603): A Phase II or III Randomized Controlled Trial.,"PURPOSE


Adjuvant chemotherapy after hepatectomy is controversial in liver-only metastatic colorectal cancer (CRC). We conducted a randomized controlled trial to examine if adjuvant modified infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) is superior to hepatectomy alone for liver-only metastasis from CRC.
PATIENTS AND METHODS


In this phase II or III trial (JCOG0603), patients age 20-75 years with confirmed CRC and an unlimited number of liver metastatic lesions were randomly assigned to hepatectomy alone or 12 courses of adjuvant mFOLFOX6 after hepatectomy. The primary end point of phase III was disease-free survival (DFS) in intention-to-treat analysis.
RESULTS


Between March 2007 and January 2019, 300 patients were randomly assigned to hepatectomy alone (149 patients) or hepatectomy followed by chemotherapy (151 patients). At the third interim analysis of phase III with median follow-up of 53.6 months, the trial was terminated early according to the protocol because DFS was significantly longer in patients treated with hepatectomy followed by chemotherapy. With median follow-up of 59.2 months, the updated 5-year DFS was 38.7% (95% CI, 30.4 to 46.8) for hepatectomy alone compared with 49.8% (95% CI, 41.0 to 58.0) for chemotherapy (hazard ratio, 0.67; 95% CI, 0.50 to 0.92; one-sided  P  = .006). However, the updated 5-year overall survival (OS) was 83.1% (95% CI, 74.9 to 88.9) with hepatectomy alone and 71.2% (95% CI, 61.7 to 78.8) with hepatectomy followed by chemotherapy. In the chemotherapy arm, the most common grade 3 or higher severe adverse event was neutropenia (50% of patients), followed by sensory neuropathy (10%) and allergic reaction (4%). One patient died of unknown cause after three courses of mFOLFOX6 administration.
CONCLUSION


DFS did not correlate with OS for liver-only metastatic CRC. Adjuvant chemotherapy with mFOLFOX6 improves DFS among patients treated with hepatectomy for CRC liver metastasis. It remains unclear whether chemotherapy improves OS.",2021,"However, the updated 5-year overall survival (OS) was 83.1% (95% CI, 74.9 to 88.9) with hepatectomy alone and 71.2% (95% CI, 61.7 to 78.8) with hepatectomy followed by chemotherapy.","['Between March 2007 and January 2019', 'patients age 20-75 years with confirmed CRC and an unlimited number of liver metastatic lesions', 'for Liver-Only Metastatic Colorectal Cancer (JCOG0603', '300 patients', '149 patients) or', 'patients treated with hepatectomy for CRC liver metastasis', 'liver-only metastasis from CRC', 'liver-only metastatic colorectal cancer (CRC']","['hepatectomy alone or 12 courses of adjuvant mFOLFOX6 after hepatectomy', 'hepatectomy followed by chemotherapy', 'adjuvant modified infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6', 'Adjuvant chemotherapy with mFOLFOX6', 'Hepatectomy Followed by mFOLFOX6 Versus Hepatectomy Alone', 'hepatectomy alone']","['neutropenia', 'updated 5-year DFS', 'allergic reaction', 'DFS', 'disease-free survival (DFS', 'OS', '5-year overall survival (OS']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",300.0,0.228011,"However, the updated 5-year overall survival (OS) was 83.1% (95% CI, 74.9 to 88.9) with hepatectomy alone and 71.2% (95% CI, 61.7 to 78.8) with hepatectomy followed by chemotherapy.","[{'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Kanemitsu', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Inaba', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Hamaguchi', 'Affiliation': 'Saitama Medical University International Medical Center, Hidaka, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Shida', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohue', 'Affiliation': 'Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Komori', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Shiomi', 'Affiliation': 'Shizuoka Cancer Center Hospital, Shizuoka, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Shiozawa', 'Affiliation': 'Kanagawa Cancer Center, Kanagawa, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Watanabe', 'Affiliation': 'Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Suto', 'Affiliation': 'Yamagata Prefectural Central Hospital, Yamagata, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kinugasa', 'Affiliation': 'Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Takii', 'Affiliation': 'Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Ishikawa Prefectural Central Hospital, Kanazawa, Japan.'}, {'ForeName': 'Takaya', 'Initials': 'T', 'LastName': 'Kobatake', 'Affiliation': 'National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Inomata', 'Affiliation': 'Oita University Faculty of Medicine, Yufu, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': 'Kochi Health Sciences Center, Kochi, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.01032']
938,34994118,Effect of the temperature of sodium hypochlorite on the cyclic fatigue resistance of ProTaper Gold rotary files.,"BACKGROUND


Instrument fracture is one of major challenges during root canal treatment. In order to reduce such errors, it seems necessary to investigate the effects of potentially impactful factors. One of such factors could be the temperature of an agitator.
OBJECTIVES


This study examined the effects of different temperature of the sodium hypochlorite solution on the cyclic fatigue resistance of ProTaper Gold (PTG) rotary files.
MATERIAL AND METHODS


Forty-five PTG S1 rotary files were tested in a metal block that simulated a canal curvature angle of 60° and a curvature radius of 5 mm. They were randomly divided into 3 groups of 15 according to sodium hypochlorite temperatures of 22°C (group 1), 4°C (group 2) and 37°C (group 3). Files from each group were rotated at 300 rpm in the block at each temperature. The number of cycles to fracture was calculated and the fragment length was measured. The fractured surfaces were examined by means of scanning electron microscopy (SEM). The statistical analysis was completed using the Kolmogorov-Smirnov and Kruskal-Wallis tests, and the IBM SPSS Statistics for Windows software, v. 22.0, at a significance level of 5%.
RESULTS


The cyclic fatigue resistance of the PTG rotary files was not significantly affected by the temperature of sodium hypochlorite (p > 0.05).
CONCLUSIONS


Increasing the temperature of sodium hypochlorite to 37°C or decreasing it to 4°C did not significantly affect the cyclic fatigue resistance of PTG rotary files.",2021,"The cyclic fatigue resistance of the PTG rotary files was not significantly affected by the temperature of sodium hypochlorite (p > 0.05).
","['ProTaper Gold rotary files', 'Forty-five PTG S1 rotary files were tested in a metal block that simulated a canal curvature angle of 60° and a curvature radius of 5 mm']","['sodium hypochlorite solution', 'sodium hypochlorite']","['cyclic fatigue resistance', 'number of cycles to fracture', 'IBM SPSS Statistics']","[{'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}]","[{'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0238190', 'cui_str': 'Inclusion body myositis'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}]",,0.0516817,"The cyclic fatigue resistance of the PTG rotary files was not significantly affected by the temperature of sodium hypochlorite (p > 0.05).
","[{'ForeName': 'Seyed Amir', 'Initials': 'SA', 'LastName': 'Mousavi', 'Affiliation': 'Dental Research Center, Department of Endodontics, School of Dentistry, Isfahan University of Medical Sciences, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Norouzi', 'Affiliation': 'Dental Research Center, Department of Endodontics, School of Dentistry, Isfahan University of Medical Sciences, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Memarzadeh', 'Affiliation': 'Dental Research Center, Department of Endodontics, School of Dentistry, Isfahan University of Medical Sciences, Iran.'}, {'ForeName': 'Seyed Rohollah', 'Initials': 'SR', 'LastName': 'Havaei', 'Affiliation': 'Dental Research Center, Department of Endodontics, School of Dentistry, Isfahan University of Medical Sciences, Iran.'}, {'ForeName': 'Hazhir', 'Initials': 'H', 'LastName': 'Yousefshahi', 'Affiliation': 'Department of Endodontics, School of Dentistry, Islamic Azad University of Medical Sciences, Tehran, Iran.'}]",Dental and medical problems,['10.17219/dmp/126260']
939,34550757,Poziotinib for Patients With  HER2  Exon 20 Mutant Non-Small-Cell Lung Cancer: Results From a Phase II Trial.,"PURPOSE


Targeted therapies against non-small-cell lung cancer (NSCLC) harboring  HER2  mutations remain an unmet need. In this study, we assessed the efficacy and safety of poziotinib in patients with  HER2  exon 20 mutant advanced NSCLC in a single-arm, open-label, phase II study.
PATIENTS AND METHODS


Patients with advanced  HER2  exon 20 mutant NSCLC were enrolled to receive poziotinib at a dose of 16 mg/d for 28-day cycles. The primary end point was objective response rate per RECIST version 1.1. Confirmatory scans were performed at least 28 days from initial radiologic response.
RESULTS


Thirty patients received poziotinib treatment. At baseline, 90% of patients received prior platinum-based chemotherapy and 53% had two lines or more prior systemic therapies. As of data cutoff on March 1, 2021, the confirmed objective response rate was 27% (95% CI, 12 to 46). Responses were observed across  HER2  exon 20 mutation subtypes. The median duration of response was 5.0 months (95% CI, 4.0 to not estimable). The median progression-free survival was 5.5 months (95% CI, 4.0 to 7.0). The median overall survival was 15 months (95% CI, 9.0 to not estimable). The most common grade 3 treatment-related adverse events were skin rash (47%) and diarrhea (20%). There was one possible treatment-related death because of pneumonitis.
CONCLUSION


Poziotinib showed promising antitumor activity in patients with  HER2  exon 20 mutant NSCLC including patients who had previously received platinum-based chemotherapy.",2022,The most common grade 3 treatment-related adverse events were skin rash (47%) and diarrhea (20%).,"['Thirty patients received poziotinib treatment', 'patients with  HER2  exon 20 mutant NSCLC including patients who had previously received platinum-based chemotherapy', 'Patients with advanced  HER2  exon 20 mutant', 'Exon 20 Mutant Non-Small-Cell Lung Cancer', 'patients with  HER2  exon 20 mutant advanced NSCLC in a single-arm, open-label, phase II study', 'Patients With  HER2', 'non-small-cell lung cancer (NSCLC) harboring  HER2']","['prior platinum-based chemotherapy', 'poziotinib']","['median progression-free survival', 'objective response rate per RECIST version 1.1', 'skin rash', 'antitumor activity', 'efficacy and safety', 'median overall survival', 'objective response rate', 'diarrhea', 'median duration of response']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}]","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.24582,The most common grade 3 treatment-related adverse events were skin rash (47%) and diarrhea (20%).,"[{'ForeName': 'Yasir Y', 'Initials': 'YY', 'LastName': 'Elamin', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jacqulyne P', 'Initials': 'JP', 'LastName': 'Robichaux', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Brett W', 'Initials': 'BW', 'LastName': 'Carter', 'Affiliation': 'Department of Thoracic Imaging, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Altan', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Don L', 'Initials': 'DL', 'LastName': 'Gibbons', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Frank V', 'Initials': 'FV', 'LastName': 'Fossella', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Vincent K', 'Initials': 'VK', 'LastName': 'Lam', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Anisha B', 'Initials': 'AB', 'LastName': 'Patel', 'Affiliation': 'Department of Dermatology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Marcelo V', 'Initials': 'MV', 'LastName': 'Negrao', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Xiuning', 'Initials': 'X', 'LastName': 'Le', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Mott', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blumenschein', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Tsao', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Heymach', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.01113']
940,34554015,Optimal allocation to treatments in a sequential multiple assignment randomized trial.,"One of the main questions in the design of a trial is how many subjects should be assigned to each treatment condition. Previous research has shown that equal randomization is not necessarily the best choice. We study the optimal allocation for a novel trial design, the sequential multiple assignment randomized trial, where subjects receive a sequence of treatments across various stages. A subject's randomization probabilities to treatments in the next stage depend on whether he or she responded to treatment in the current stage. We consider a prototypical sequential multiple assignment randomized trial design with two stages. Within such a design, many pairwise comparisons of treatment sequences can be made, and a multiple-objective optimal design strategy is proposed to consider all such comparisons simultaneously. The optimal design is sought under either a fixed total sample size or a fixed budget. A Shiny App is made available to find the optimal allocations and to evaluate the efficiency of competing designs. As the optimal design depends on the response rates to first-stage treatments, maximin optimal design methodology is used to find robust optimal designs. The proposed methodology is illustrated using a sequential multiple assignment randomized trial example on weight loss management.",2021,"We study the optimal allocation for a novel trial design, the sequential multiple assignment randomized trial, where subjects receive a sequence of treatments across various stages.",[],[],[],[],[],[],,0.124935,"We study the optimal allocation for a novel trial design, the sequential multiple assignment randomized trial, where subjects receive a sequence of treatments across various stages.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Morciano', 'Affiliation': 'Findomestic Banca, Florence, Italy.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Moerbeek', 'Affiliation': 'Department of Methodology and Statistics, Utrecht University, the Netherlands.'}]",Statistical methods in medical research,['10.1177/09622802211037066']
941,34533774,Iron deficiency and biomarkers of inflammation: a 3-year prospective analysis of the DO-HEALTH trial.,"BACKGROUND


The longitudinal association between iron deficiency and inflammatory biomarkers levels has not been fully explored among relatively healthy older adults.
AIMS


To assess whether iron deficiency at baseline and at any yearly follow-up time point, with or without anemia, was associated with changes from baseline in high-sensitivity C-reactive protein (hs-CRP) and interleukin-6 (IL-6) levels over 3 years.
METHODS


This is a post-hoc observational analysis of DO-HEALTH, a double-blind, randomized controlled trial including 2157 European community-dwelling adults age 70+. The outcomes were changes from baseline in hs-CRP and IL-6 levels, measured at 12, 24, and 36 months of follow-up. Iron deficiency was defined by soluble transferrin receptor levels > 28.1 nmol/L and baseline anemia by hemoglobin levels < 130 g/L for men and < 120 g/L for women.
RESULTS


In total, 2141 participants were included in the analyses (mean age: 74.9 years, 61.5% of women, 26.8% with iron deficiency). Baseline iron deficiency was associated with greater increase in IL-6 levels (mean difference in change: 0.52 ng/L, 95%CI 0.03-1.00, P = .04) over 3 years. Iron deficiency at any yearly time point was associated with higher increases in hs-CRP (mean difference in change: 1.62 mg/L, 95%CI 0.98-2.26, P < .001) and IL-6 levels (mean difference in change: 1.33 ng/L, 95%CI 0.87-1.79, P < .001) over 3 years. No significant interaction between iron deficiency and anemia was found, suggesting that the results are independent of the anemic status.
CONCLUSIONS


These findings suggest that iron deficiency may play a role in low-grade chronic inflammation among relatively healthy older adults.",2022,"Baseline iron deficiency was associated with greater increase in IL-6 levels (mean difference in change: 0.52 ng/L, 95%CI 0.03-1.00, P = .04) over 3 years.","['2141 participants were included in the analyses (mean age: 74.9\xa0years, 61.5% of women, 26.8% with iron deficiency', 'relatively healthy older adults', '2157 European community-dwelling adults age 70']",[],"['IL-6 levels', 'hs-CRP and IL-6 levels', 'Iron deficiency and biomarkers of inflammation', 'hs-CRP', 'high-sensitivity C-reactive protein (hs-CRP) and interleukin-6 (IL-6) levels']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",2157.0,0.586377,"Baseline iron deficiency was associated with greater increase in IL-6 levels (mean difference in change: 0.52 ng/L, 95%CI 0.03-1.00, P = .04) over 3 years.","[{'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Wieczorek', 'Affiliation': 'Department of Aging Medicine and Aging Research, University Hospital Zurich and University of Zurich, Raemistrasse 101, 8091, Zurich, Switzerland.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Schwarz', 'Affiliation': 'Department of Aging Medicine and Aging Research, University Hospital Zurich and University of Zurich, Raemistrasse 101, 8091, Zurich, Switzerland.'}, {'ForeName': 'Angélique', 'Initials': 'A', 'LastName': 'Sadlon', 'Affiliation': 'Department of Aging Medicine and Aging Research, University Hospital Zurich and University of Zurich, Raemistrasse 101, 8091, Zurich, Switzerland.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Abderhalden', 'Affiliation': 'Department of Aging Medicine and Aging Research, University Hospital Zurich and University of Zurich, Raemistrasse 101, 8091, Zurich, Switzerland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'de Godoi Rezende Costa Molino', 'Affiliation': 'Department of Aging Medicine and Aging Research, University Hospital Zurich and University of Zurich, Raemistrasse 101, 8091, Zurich, Switzerland.'}, {'ForeName': 'Donat R', 'Initials': 'DR', 'LastName': 'Spahn', 'Affiliation': 'Institute of Anesthesiology, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Dominik J', 'Initials': 'DJ', 'LastName': 'Schaer', 'Affiliation': 'Division of Internal Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': 'Department of Biostatistics, Harvard School of Public Health, Boston, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Egli', 'Affiliation': 'Department of Aging Medicine and Aging Research, University Hospital Zurich and University of Zurich, Raemistrasse 101, 8091, Zurich, Switzerland.'}, {'ForeName': 'Heike A', 'Initials': 'HA', 'LastName': 'Bischoff-Ferrari', 'Affiliation': 'Department of Aging Medicine and Aging Research, University Hospital Zurich and University of Zurich, Raemistrasse 101, 8091, Zurich, Switzerland. Heike.Bischoff@usz.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Aging clinical and experimental research,['10.1007/s40520-021-01955-3']
942,34536266,Excising or preserving perforation margins in endoscopic transtympanic cartilage myringoplasty does not affect surgical success.,"OBJECTIVE


To compare the outcome of endoscopic transtympanic cartilage myringoplasty with and without removal of perforation edges for repairing chronic perforations with mucosal chronic otitis media (COM).
STUDY DESIGN


Quasi-randomised clinical trial.
SETTING


Tertiary referral centre.
MATERIALS AND METHODS


Patients with chronic perforations and mucosal COM undergoing endoscopic transtympanic cartilage myringoplasty were allocated to a control group for whom the perforation edges were preserved (n = 40) and an intervention group for whom the edges were removed (n = 39). Mean operation time, graft success rate, mean scores of graft neovascularisation and epithelialisation, and hearing were compared between the groups at 4 weeks and/or 6 months postoperatively.
RESULTS


Graft success rate was 95% (38/40) in the control group and 97% (38/39) in the intervention group at 6 months postoperatively; the difference was not significant. Mean graft neovascularisation scores 4 weeks postoperatively were 2.52 ± 0.59 in the control group and 2.58 ± 0.55 in the intervention group; the difference was not significant. Mean graft epithelisation scores 4 weeks postoperatively were 1.48 ± 0.57 in the control group and 1.68 ± 0.51 in the intervention group; the difference was not significant and remained nonsignificant 6 months postoperatively (2.5 ± 0.55 vs. 2.76 ± 0.36). Audiological outcomes at 6 months did not differ between the groups.
CONCLUSION


Endoscopic, transtympanic cartilage underlay myringoplasty with preservation of the perforation margins did not affect graft neovascularisation, epithelialisation or success. Longer-term outcomes and risk of cholesteatoma require further study.",2022,Mean graft neovascularization scores 4 weeks postoperatively were 2.52±0.59 in the control group and 2.58±0.55 in the intervention group; the difference was not significant.,"['Patients with chronic perforations and mucosal COM undergoing endoscopic transtympanic cartilage myringoplasty', 'repairing chronic perforations with mucosal chronic otitis media (COM', 'Tertiary referral center']",['endoscopic transtympanic cartilage myringoplasty with and without removal of perforation edges'],"['Mean graft neovascularization scores', 'Mean graft epithelization scores', 'graft neovascularization, epithelialization, or success', 'Mean operation time, graft success rate, mean scores of graft neovascularization and epithelialization, and hearing', 'Graft success rate', 'Audiological outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0271441', 'cui_str': 'Chronic otitis media'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0442388', 'cui_str': 'Transtympanic approach'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0442388', 'cui_str': 'Transtympanic approach'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0644307,Mean graft neovascularization scores 4 weeks postoperatively were 2.52±0.59 in the control group and 2.58±0.55 in the intervention group; the difference was not significant.,"[{'ForeName': 'Zhengcai', 'Initials': 'Z', 'LastName': 'Lou', 'Affiliation': 'Department of Otorhinolaryngology, Yiwu central Hospital, Yiwu, China.'}, {'ForeName': 'Zihan', 'Initials': 'Z', 'LastName': 'Lou', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Kangfeng', 'Initials': 'K', 'LastName': 'Jin', 'Affiliation': 'Department of Otorhinolaryngology, Yiwu central Hospital, Yiwu, China.'}, {'ForeName': 'Junzhi', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Otorhinolaryngology, Yiwu central Hospital, Yiwu, China.'}, {'ForeName': 'Zhengnong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}]",Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery,['10.1111/coa.13863']
943,34542612,Impact of coronary calcification assessed by coronary CT angiography on treatment decision in patients with three-vessel CAD: insights from SYNTAX III trial.,"OBJECTIVES


The aim of this study was to determine Syntax scores based on coronary computed tomography angiography (CCTA) and invasive coronary angiography (ICA) and to assess whether heavy coronary calcification significantly limits the CCTA evaluation and the impact of severe calcification on heart team's treatment decision and procedural planning in patients with three-vessel coronary artery disease (CAD) with or without left main disease.
METHODS


SYNTAX III was a multicentre, international study that included patients with three-vessel CAD with or without left main disease. The heart teams were randomized to either assess coronary arteries with coronary CCTA or ICA. We stratified the patients based on the presence of at least 1 lesion with heavy calcification defined as arc of calcium >180° within the lesion using CCTA. Agreement on the anatomical SYNTAX score and treatment decision was compared between patients with and without heavy calcifications.
RESULTS


Overall, 222 patients with available CCTA and ICA were included in this trial subanalysis (104 with heavy calcification, 118 without heavy calcification). The mean difference in the anatomical SYNTAX score (CCTA derived-ICA derived) was lower in patients without heavy calcifications [mean (-1.96 SD; +1.96 SD) = 1.5 (-19.3; 22.4) vs 5.9 (-17.5; +29.3), P = 0.004]. The agreement on treatment decision did not differ between patients with (Cohen's kappa 0.79) or without coronary calcifications (Cohen's kappa 0.84). The agreement on the treatment planning did not differ between patients with (concordance 80.3%) or without coronary calcifications (concordance 82.8%).
CONCLUSIONS


An overall good correlation between CCTA- and ICA-derived Syntax score was found. The presence of heavy coronary calcification moderately influenced the agreement between CCTA and ICA on the anatomical SYNTAX score. However, agreement on the treatment decision and planning was high and irrespective of the presence of calcified lesions.",2022,The mean difference in the anatomical SYNTAX score (CCTA derived-ICA derived) was lower in patients without heavy calcifications [mean (-1.96 SD; +1.96 SD) =,"['patients with three-vessel coronary artery disease (CAD) with or without left main disease', 'SYNTAX III was a multicentre, international study that included patients with three-vessel CAD with or without left main disease', 'patients with three-vessel CAD', '222 patients with available CCTA and ICA were included in this trial subanalysis (104 with heavy calcification, 118 without heavy calcification']","['coronary arteries with coronary CCTA or ICA', 'coronary CT angiography', 'coronary computed tomography angiography (CCTA) and invasive coronary angiography (ICA']","['heavy coronary calcification', 'Syntax scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010075', 'cui_str': 'Coronary Vessels'}, {'cui': 'C0852949', 'cui_str': 'Disorder of artery'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",222.0,0.0662731,The mean difference in the anatomical SYNTAX score (CCTA derived-ICA derived) was lower in patients without heavy calcifications [mean (-1.96 SD; +1.96 SD) =,"[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Andreini', 'Affiliation': 'Department of Cardiovascular Imaging, Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Mushtaq', 'Affiliation': 'Department of Cardiovascular Imaging, Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Conte', 'Affiliation': 'Department of Cardiovascular Imaging, Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Sonck', 'Affiliation': 'Cardiovascular Center Aalst, OLV Hospital, Aalst, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'De Mey', 'Affiliation': 'Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ravagnani', 'Affiliation': 'Department of Cardiovascular Imaging, Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Schoors', 'Affiliation': 'University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Maisano', 'Affiliation': 'University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kaufmann', 'Affiliation': 'University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Wietze', 'Initials': 'W', 'LastName': 'Lindeboom', 'Affiliation': 'Cardialysis BV, Rotterdam, Netherlands.'}, {'ForeName': 'Marie-Angele', 'Initials': 'MA', 'LastName': 'Morel', 'Affiliation': 'Cardialysis BV, Rotterdam, Netherlands.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Doenst', 'Affiliation': 'Jena University Hospital, Friedrich-Schiller-University of Jena, Jena, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Teichgräber', 'Affiliation': 'Jena University Hospital, Friedrich-Schiller-University of Jena, Jena, Germany.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pontone', 'Affiliation': 'Department of Cardiovascular Imaging, Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Pompilio', 'Affiliation': 'Department of Cardiovascular Imaging, Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bartorelli', 'Affiliation': 'Department of Cardiovascular Imaging, Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Thoraxcenter, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, Royal Brompton and Harefield Hospitals, Imperial College London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivab249']
944,34540188,Postoperative Effects of Dexmedetomidine on Serum Inflammatory Factors and Cognitive Malfunctioning in Patients with General Anesthesia.,"Objective


To investigate the effects of dexmedetomidine intervention on serum inflammatory factor concentration and postoperative cognitive malfunction in elderly patients with general anesthesia.  Methodology . 174 patients with general anesthesia were selected, who were categorized into a control group (HC) and a dexmedetomidine group (HS) using the random number table method, with 87 patients in individual groups. The dexmedetomidine group was pumped intravenously with dexmedetomidine at a loading dose of 1  μ g/kg before induction of anesthesia for 15 min, followed by continuous intravenous pumping at a rate of 0.4  μ g/kg/h, and the dosing was stopped at 30 min before concluding the surgery. The control group was administered the identical dose of saline in the same manner. Interleukin 6 (IL-6) and tumor necrosis factor  α  (TNF- α ) levels and MMES scores were tested at 1 h before and 24 h after anesthesia.
Results


Comparing to HC group, patients in the HS group had lower TNF- α  and IL-6 levels at both scheduled points ( P  < 0.05).
Conclusion


Dexmedetomidine reduced the expression of inflammatory factors in elderly patients with general anesthesia and effectively reduced the incidence of postoperative cognitive dysfunction after general anesthesia surgery.",2021,"Comparing to HC group, patients in the HS group had lower TNF- α  and IL-6 levels at both scheduled points ( P  < 0.05).
","['elderly patients with general anesthesia', 'Patients with General Anesthesia', 'group (HS) using the random number table method, with 87 patients in individual groups', '174 patients with general anesthesia']","['HC', 'dexmedetomidine', 'dexmedetomidine intervention', 'Dexmedetomidine']","['Interleukin 6 (IL-6) and tumor necrosis factor  α  (TNF- α ) levels and MMES scores', 'postoperative cognitive dysfunction', 'expression of inflammatory factors', 'lower TNF- α  and IL-6 levels', 'Serum Inflammatory Factors and Cognitive Malfunctioning', 'serum inflammatory factor concentration and postoperative cognitive malfunction']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517604', 'cui_str': '174'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0066662', 'cui_str': '1,2,3,4,9,9-hexachloro-1,4,4a,5,8,8a-hexahydro-6- methyl-6,7-epoxy-1,4-methanonaphthalene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",174.0,0.0416185,"Comparing to HC group, patients in the HS group had lower TNF- α  and IL-6 levels at both scheduled points ( P  < 0.05).
","[{'ForeName': 'Zitan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The Fourth Hospital of Hebei Medical University, 12 Jiankang Road Shijiazhuang, Hebei 050011, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Hebei Medical University, 215 Heping West Road Shijiazhuang, Hebei 050000, China.'}, {'ForeName': 'Huiqun', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Department of Anesthesiology, The Fourth Hospital of Hebei Medical University, 12 Jiankang Road Shijiazhuang, Hebei 050011, China.'}]",Journal of healthcare engineering,['10.1155/2021/7161901']
945,34528669,Is Medication Adherence Predictive of Cardiovascular Outcomes and Blood Pressure Control? The Systolic Blood Pressure Intervention Trial (SPRINT).,"BACKGROUND


Adherence to study medications is crucial to evaluating treatment effects in clinical trials. To assess whether in the SPRINT trial, adherence and cardiovascular outcomes are associated regardless of intervention assignment.
METHODS


This study included 9,361 participants aged ≥50 years, recruited from 102 clinics. Participants were randomized to a Standard Treatment Group (targeted systolic blood pressure [SBP] <140 mm Hg) or an Intensive Treatment Group (targeted SBP <120 mm Hg) and followed for incident cardiovascular events until the study was halted early for benefit. The 8-item Morisky Medication Adherence Scale (MMAS-8) was administered at baseline, and at the 12- and 48-month (or close out) visit.
RESULTS


Adjusting for covariates, there was no association between the baseline 8-item MMAS-8 and the likelihood of the primary composite endpoint, any of the secondary endpoints, or blood pressure (BP) control. Low adherence was associated with a higher body mass index, SBP, diastolic BP, and Patient Health Questionnaire, and high adherence was associated with a higher Montreal Cognitive Assessment. There was no difference in the MMAS-8 over time by treatment arm assignment. For the primary outcome (a composite of myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes), baseline odds ratios (95% confidence intervals) for the Low vs. Medium and vs. High; and, for Medium vs. High MMAS-8 were 1.02 (0.82-1.28), 1.07 (0.85-1.34), and 1.05 (0.88-1.250).
CONCLUSIONS


In SPRINT, medication adherence as measured using the MMAS-8 was not associated with outcomes or BP control.",2022,"Low adherence was associated with a higher BMI, SBP, DBP, and PHQ-9, and high adherence was associated with a higher MOCA.","['9361 participants aged ≥ 50 years, recruited from 102 clinics']",['Standard Treatment Group (targeted SBP <140 mmHg) or an Intensive Treatment Group (targeted SBP'],"['MMAS-8', 'higher BMI, SBP, DBP, and PHQ-9, and high adherence', '8-item Morisky Medication Adherence Scale (MMAS-8', 'composite of myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes), baseline odds ratios']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}]","[{'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",9361.0,0.42791,"Low adherence was associated with a higher BMI, SBP, DBP, and PHQ-9, and high adherence was associated with a higher MOCA.","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Glasser', 'Affiliation': 'Department of Medicine (Cardiology), University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Vitolins', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Section on Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Carolyn Harmon', 'Initials': 'CH', 'LastName': 'Still', 'Affiliation': 'Frances Payne Bolton, School of Nursing, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Stacey S', 'Initials': 'SS', 'LastName': 'Cofield', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Mayo Clinic Division of Nephrology and Hypertension, Jacksonville, Florida, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goff', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute (NIH/NHLBI), Bethesda, Maryland, USA.'}]",American journal of hypertension,['10.1093/ajh/hpab145']
946,34551415,Enhancing Cognitive Restructuring with Concurrent Repetitive Transcranial Magnetic Stimulation: A Transdiagnostic Randomized Controlled Trial.,"INTRODUCTION


Emotional dysregulation constitutes a serious public health problem in need of novel transdiagnostic treatments.
OBJECTIVE


To this aim, we developed and tested a one-time intervention that integrates behavioral skills training with concurrent repetitive transcranial magnetic stimulation (rTMS).
METHODS


Forty-six adults who met criteria for at least one DSM-5 disorder and self-reported low use of cognitive restructuring (CR) were enrolled in a randomized, double-blind, sham-controlled trial that used a between-subjects design. Participants were taught CR and underwent active rTMS applied at 10 Hz over the right (n = 17) or left (n = 14) dorsolateral prefrontal cortex (dlPFC) or sham rTMS (n = 15) while practicing reframing and emotional distancing in response to autobiographical stressors.
RESULTS


Those who received active left or active right as opposed to sham rTMS exhibited enhanced regulation (ds = 0.21-0.62) as measured by psychophysiological indices during the intervention (higher high-frequency heart rate variability, lower regulation duration). Those who received active rTMS over the left dlPFC also self-reported reduced distress throughout the intervention (d = 0.30), higher likelihood to use CR, and lower daily distress during the week following the intervention. The procedures were acceptable and feasible with few side effects.
CONCLUSIONS


These findings show that engaging frontal circuits simultaneously with cognitive skills training and rTMS may be clinically feasible, well-tolerated and may show promise for the treatment of transdiagnostic emotional dysregulation. Larger follow-up studies are needed to confirm the efficacy of this novel therapeutic approach.",2022,"Those who received active left or active right as opposed to sham rTMS exhibited enhanced regulation (ds = 0.21-0.62) as measured by psychophysiological indices during the intervention (higher high-frequency heart rate variability, lower regulation duration).",['Forty-six adults who met criteria for at least one DSM-5 disorder and self-reported low use of cognitive restructuring (CR'],"['Enhancing Cognitive Restructuring with Concurrent Repetitive Transcranial Magnetic Stimulation', 'dorsolateral prefrontal cortex (dlPFC) or sham rTMS (n = 15) while practicing reframing and emotional distancing', 'integrates behavioral skills training with concurrent repetitive transcranial magnetic stimulation (rTMS', 'active rTMS']",['daily distress'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring'}]","[{'cui': 'C0150173', 'cui_str': 'Cognitive restructuring'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",46.0,0.0473228,"Those who received active left or active right as opposed to sham rTMS exhibited enhanced regulation (ds = 0.21-0.62) as measured by psychophysiological indices during the intervention (higher high-frequency heart rate variability, lower regulation duration).","[{'ForeName': 'Andrada D', 'Initials': 'AD', 'LastName': 'Neacsiu', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Lysianne', 'Initials': 'L', 'LastName': 'Beynel', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Powers', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Steven T', 'Initials': 'ST', 'LastName': 'Szabo', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Appelbaum', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'LaBar', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}]",Psychotherapy and psychosomatics,['10.1159/000518957']
947,34533211,Similar mortality risk in incident cognitive impairment and dementia: Evidence from the ASPirin in Reducing Events in the Elderly (ASPREE) trial.,"BACKGROUND


This study examined the risk of mortality in older adults with newly detected cognitive impairment or dementia.
METHODS


Data from the Australian cohort of the ASPirin in Reducing Events in the Elderly (ASPREE) trial were examined. The ASPREE clinical trial compared daily low-dose aspirin to a placebo and involved 16,703 individuals aged 70 years and over, who were without major cognitive impairment, physical disability, or cardiovascular disease at recruitment. During the trial, evidence of cognitive impairment, based on cognitive testing and medical record information, triggered dementia adjudication of participants using DSM-IV criteria. Cox proportional hazard models were used to compare mortality rates across the dementia, trigger-only, and no-trigger groups.
RESULTS


Over a median 4.7-year follow-up period, 806 participants triggered dementia adjudication, with 485 (60.2%) judged to have dementia. Following recruitment, mortality risks were 32.9, 33.6, and 10.8 events per 1000 person-years in the dementia, trigger-no-dementia, and no-trigger groups, respectively. In the fully adjusted model, mortality risks remained higher in the dementia and trigger-no-dementia groups, with hazard ratios of 1.7 (95% CI: 1.3-2.1) and 1.9 (95% CI: 1.5-2.6), respectively. There was no discernible difference between the dementia and trigger-no-dementia groups in mortality rates following recruitment, or following a dementia trigger. These two groups were more likely to die from sepsis, respiratory disease, and dementia, but less likely to die from cancer than the no-trigger group, χ 2   = 161.5, p < 0.001.
CONCLUSION


ASPREE participants who triggered for a dementia evaluation experienced a substantially higher mortality rate than those who remained cognitively intact. The increase was indistinguishable among persons who met DSM-IV criteria for dementia vs. those who triggered for a dementia evaluation but failed to meet DSM-IV criteria. Future work should investigate whether earlier detection of cognitive decline can be used to identify and prevent early mortality.",2021,"There was no discernible difference between the dementia and trigger-no-dementia groups in mortality rates following recruitment, or following a dementia trigger.","['806 participants triggered dementia adjudication, with 485 (60.2%) judged to have dementia', 'older adults with newly detected cognitive impairment or dementia', 'Data from the Australian cohort of the', '16,703 individuals aged 70\u2009years and over, who were without major cognitive impairment, physical disability, or cardiovascular disease at recruitment']","['aspirin', 'placebo', 'ASPirin']","['dementia and trigger-no-dementia groups in mortality rates', 'die from sepsis, respiratory disease, and dementia', 'mortality rates', 'mortality risks', 'mortality rate']","[{'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",16703.0,0.338842,"There was no discernible difference between the dementia and trigger-no-dementia groups in mortality rates following recruitment, or following a dementia trigger.","[{'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Banaszak-Holl', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Ward', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Brodaty', 'Affiliation': 'Centre for Healthy Brain Ageing (CHeBA), School of Psychiatry, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Elsdon', 'Initials': 'E', 'LastName': 'Storey', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, Illinois, USA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Health Research Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Sharyn M', 'Initials': 'SM', 'LastName': 'Fitzgerald', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.17435']
948,34542241,The impact of experimental pain on shoulder movement during an arm elevated reaching task in a virtual reality environment.,"BACKGROUND


People with chronic shoulder pain have been shown to present with motor adaptations during arm movements. These adaptations may create abnormal physical stress on shoulder tendons and muscles. However, how and why these adaptations develop from the acute stage of pain is still not well-understood.
OBJECTIVE


To investigate motor adaptations following acute experimental shoulder pain during upper limb reaching.
METHODS


Forty participants were assigned to the Control or Pain group. They completed a task consisting of reaching targets in a virtual reality environment at three time points: (1) baseline (both groups pain-free), (2) experimental phase (Pain group experiencing acute shoulder pain induced by injecting hypertonic saline into subacromial space), and (3) Post experimental phase (both groups pain-free). Electromyographic (EMG) activity, kinematics, and performance data were collected.
RESULTS


The Pain group showed altered movement planning and execution as shown by a significant increased delay to reach muscles EMG peak and a loss of accuracy, compared to controls that have decreased their mean delay to reach muscles peak and improved their movement speed through the phases. The Pain group also showed protective kinematic adaptations using less shoulder elevation and elbow flexion, which persisted when they no longer felt the experimental pain.
CONCLUSION


Acute experimental pain altered movement planning and execution, which affected task performance. Kinematic data also suggest that such adaptations may persist over time, which could explain those observed in chronic pain populations.",2021,"The Pain group showed altered movement planning and execution as shown by a significant increased delay to reach muscles EMG peak and a loss of accuracy, compared to controls that have decreased their mean delay to reach muscles peak and improved their movement speed through the phases.","['People with chronic shoulder pain', 'acute experimental shoulder pain during upper limb reaching', 'Forty participants were assigned to the Control or Pain group']",['experimental phase (Pain group experiencing acute shoulder pain induced by injecting hypertonic saline into subacromial space'],"['protective kinematic adaptations', 'shoulder elevation and elbow flexion', 'Electromyographic (EMG) activity, kinematics, and performance data', 'delay to reach muscles EMG peak and a loss of accuracy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]","[{'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",40.0,0.102273,"The Pain group showed altered movement planning and execution as shown by a significant increased delay to reach muscles EMG peak and a loss of accuracy, compared to controls that have decreased their mean delay to reach muscles peak and improved their movement speed through the phases.","[{'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Dupuis', 'Affiliation': 'Faculty of Medicine, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Sole', 'Affiliation': 'Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Wassinger', 'Affiliation': 'Physical Therapy Program, East Tennessee State University, Johnson City, TN, USA.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'Osborne', 'Affiliation': 'Department of Medicine, Otago Medical School, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Beilmann', 'Affiliation': 'Faculty of Medicine, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mercier', 'Affiliation': 'Faculty of Medicine, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Campeau-Lecours', 'Affiliation': 'Centre for Interdisciplinary Research in Rehabilitation and Social Integration, Quebec City, Canada.'}, {'ForeName': 'Laurent J', 'Initials': 'LJ', 'LastName': 'Bouyer', 'Affiliation': 'Faculty of Medicine, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Jean-Sébastien', 'Initials': 'JS', 'LastName': 'Roy', 'Affiliation': 'Faculty of Medicine, Université Laval, Quebec City, Canada.'}]",Physiological reports,['10.14814/phy2.15025']
949,34534048,Women require routine opioids to prevent painful colonoscopies: a randomised controlled trial.,"BACKGROUND


Women are at high risk for painful colonoscopy. Pain, but also sedation, are barriers to colorectal cancer (CRC) screening participation. In a randomised controlled trial, we compared on-demand with pre-colonoscopy opioid administration to control pain in women at CRC screening age.
METHODS


Women, aged 55-79 years, attending colonoscopy at two Norwegian endoscopy units were randomised 1:1:1 to (1) fentanyl on-demand, (2) fentanyl prior to colonoscopy, or (3) alfentanil on-demand. The primary endpoint was procedural pain reported by the patients on a validated four-point Likert scale and further dichotomized for the study into painful (moderate or severe pain) and non-painful (slight or no pain) colonoscopy. Secondary endpoints were: willingness to repeat colonoscopy, adverse events, cecal intubation time and rate, and post-procedure recovery time.
RESULTS


Between June 2017 and May 2020, 183 patients were included in intention-to-treat analyses in the fentanyl on-demand group, 177 in the fentanyl prior to colonoscopy group, and 179 in the alfentanil on-demand group. Fewer women receiving fentanyl prior to colonoscopy reported a painful colonoscopy compared to those who were given fentanyl on-demand (25.2% vs. 44.1%,  p  < .001). There was no difference in the proportion of painful colonoscopies between fentanyl on-demand and alfentanil on-demand (44.1% vs. 39.5%,  p  = .40). No differences were observed for adverse events or any of the other secondary endpoints between the three groups.
CONCLUSIONS


Fentanyl prior to colonoscopy provided better pain control than fentanyl or alfentanil on-demand. Fentanyl before colonoscopy should be recommended to all women at screening age.  Trial registration:  Clinicaltrials.gov (NCT01538550). Norwegian Medicines Agency (16/16266-13). EU Clinical Trials Register (EUDRACTNR. 2016-005090-13).",2021,"There was no difference in the proportion of painful colonoscopies between fentanyl on-demand and alfentanil on-demand (44.1% vs. 39.5%,  p  = .40).","['women at CRC screening age', 'Women are at high risk for painful colonoscopy', 'Women, aged 55-79\u2009years, attending colonoscopy at two Norwegian endoscopy units', 'Between June 2017 and May 2020, 183 patients were included in intention-to-treat analyses in the fentanyl on-demand group, 177 in the fentanyl prior to colonoscopy group, and 179 in the alfentanil on-demand group']","['Fentanyl', 'demand with pre-colonoscopy opioid administration', 'fentanyl on-demand, (2) fentanyl prior to colonoscopy, or (3) alfentanil on-demand', 'fentanyl or alfentanil']","['willingness to repeat colonoscopy, adverse events, cecal intubation time and rate, and post-procedure recovery time', 'proportion of painful colonoscopies', 'point Likert scale and further dichotomized for the study into painful (moderate or severe pain) and non-painful (slight or no pain) colonoscopy', 'Pain', 'adverse events', 'pain control', 'procedural pain', 'painful colonoscopy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C2937276', 'cui_str': 'Slight'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}]",183.0,0.382433,"There was no difference in the proportion of painful colonoscopies between fentanyl on-demand and alfentanil on-demand (44.1% vs. 39.5%,  p  = .40).","[{'ForeName': 'Anna Lisa', 'Initials': 'AL', 'LastName': 'Schult', 'Affiliation': 'Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Botteri', 'Affiliation': 'Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Hoff', 'Affiliation': 'Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Holme', 'Affiliation': 'Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bretthauer', 'Affiliation': 'Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kristin Ranheim', 'Initials': 'KR', 'LastName': 'Randel', 'Affiliation': 'Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway.'}, {'ForeName': 'Elisabeth Haagensen', 'Initials': 'EH', 'LastName': 'Gulichsen', 'Affiliation': 'Department of Medicine, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Badboni', 'Initials': 'B', 'LastName': 'El-Safadi', 'Affiliation': 'Department of Medicine, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Ishita', 'Initials': 'I', 'LastName': 'Barua', 'Affiliation': 'Department of Medicine, Vestre Viken Hospital Trust Baerum, Gjettum, Norway.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Munck', 'Affiliation': 'Department of Medicine, Vestre Viken Hospital Trust Baerum, Gjettum, Norway.'}, {'ForeName': 'Linn Rosén', 'Initials': 'LR', 'LastName': 'Nilsen', 'Affiliation': 'Department of Gastroenterology, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Hege Marie', 'Initials': 'HM', 'LastName': 'Svendsen', 'Affiliation': 'Department of Medicine, Vestre Viken Hospital Trust Baerum, Gjettum, Norway.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'de Lange', 'Affiliation': 'Department of Medical Research, Vestre Viken Hospital Trust Baerum, Gjettum, Norway.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2021.1969683']
950,34535170,Organizational contextual factors that predict success of a quality improvement collaborative approach to enhance integrated HIV-tuberculosis services: a sub-study of the Scaling up TB/HIV Integration trial.,"BACKGROUND


A quality improvement (QI) collaborative approach to enhancing integrated HIV-Tuberculosis (TB) services may be effective in scaling up and improving the quality of service delivery. Little is known of the role of organizational contextual factors (OCFs) in influencing the success of QI collaboratives. This study aims to determine which OCFs were associated with improvement in a QI collaborative intervention to enhance integrated HIV-TB services delivery.
METHODS


This is a nested sub-study embedded in a cluster-randomized controlled trial. Sixteen nurse supervisors (clusters) overseeing 40 clinics were randomized (1:1) to receive QI training and mentorship, or standard of care support (SOC). In the QI arm, eight nurse supervisors and 20 clinics formed a ""collaborative"" which aimed to improve HIV-TB process indicators, namely HIV testing, TB screening, isoniazid preventive therapy (IPT) initiations, viral load testing, and antiretroviral therapy for TB patients. OCFs measured at baseline were physical infrastructure, key staff, flexibility of clinic hours, monitoring data for improvement (MDI), and leadership support. Surveys were administered to clinic staff at baseline and month 12 to assess perceptions of supportiveness of contexts for change, and clinic organization for delivering integrated HIV-TB services. Linear mixed modelling was used to test for associations between OCFs and HIV-TB process indicators.
RESULTS


A total of 209 clinic staff participated in the study; 97 (46.4%) and 112 (53.6%) from QI and SOC arms, respectively. There were no differences between the QI and SOC arms scores achieved for physical infrastructure (78.9% vs 64.7%; p = 0.058), key staff (95.8 vs 92; p = 0.270), clinic hours (66.9 vs 65.5; p = 0.900), MDI (63.3 vs 65; p = 0.875, leadership support (46.0 vs 57.4; p = 0.265), and perceptions of supportiveness of contexts for change (76.2 vs 79.7; p = 0.128 and clinic organization for delivering integrated HIV-TB services (74.1 vs 80.1; p = 0.916). IPT initiation was the only indicator that was significantly improved in the parent study. MDI was a significantly associated with increasing IPT initiation rates [beta coefficient (β) = 0.004; p = 0.004].
DISCUSSION


MDI is a practice that should be fostered in public health facilities to increase the likelihood of success of future QI collaboratives to improve HIV-TB service delivery.
TRIAL REGISTRATION


Clinicaltrials.gov , NCT02654613 . Registered 01 June 2015.",2021,"This study aims to determine which OCFs were associated with improvement in a QI collaborative intervention to enhance integrated HIV-TB services delivery.
","['Sixteen nurse supervisors (clusters) overseeing 40 clinics', 'A total of 209 clinic staff participated in the study; 97 (46.4%) and 112 (53.6%) from QI and SOC arms, respectively', 'TB patients']","['isoniazid preventive therapy (IPT) initiations, viral load testing, and antiretroviral therapy', 'QI training and mentorship, or standard of care support (SOC', 'QI collaborative intervention']","['QI and SOC arms scores achieved for physical infrastructure', 'OCFs', 'MDI', 'physical infrastructure, key staff, flexibility of clinic hours, monitoring data for improvement (MDI), and leadership support', 'IPT initiation rates', 'IPT initiation']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",40.0,0.175957,"This study aims to determine which OCFs were associated with improvement in a QI collaborative intervention to enhance integrated HIV-TB services delivery.
","[{'ForeName': 'Santhanalakshmi', 'Initials': 'S', 'LastName': 'Gengiah', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Private Bag X7 Congella, Durban, 4013, South Africa. Santhana.Gengiah@caprisa.org.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Connolly', 'Affiliation': 'School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Nonhlanhla', 'Initials': 'N', 'LastName': 'Yende-Zuma', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Private Bag X7 Congella, Durban, 4013, South Africa.'}, {'ForeName': 'Pierre M', 'Initials': 'PM', 'LastName': 'Barker', 'Affiliation': 'Institute for Healthcare Improvement, Cambridge, MA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Nunn', 'Affiliation': 'Medical Research Council, Clinical Trials Unit at University College London (UCL), London, UK.'}, {'ForeName': 'Nesri', 'Initials': 'N', 'LastName': 'Padayatchi', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Private Bag X7 Congella, Durban, 4013, South Africa.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Loveday', 'Affiliation': 'CAPRISA-MRC TB-HIV Pathogenesis and Treatment Research Unit, Durban, South Africa.'}, {'ForeName': 'Kogieleum', 'Initials': 'K', 'LastName': 'Naidoo', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Private Bag X7 Congella, Durban, 4013, South Africa.'}]",Implementation science : IS,['10.1186/s13012-021-01155-7']
951,34532970,A community-based trial of a psychosocial eHealth intervention for parents of children with cancer.,"BACKGROUND


The Electronic Surviving Cancer Competently Intervention Program (eSCCIP), a psychosocial eHealth intervention for parents and caregivers of children with cancer (parents), was delivered in a community-based psychosocial oncology center. Primary endpoints were intervention acceptability, feasibility, and accessibility, with a secondary exploratory focus on psychosocial outcomes.
PROCEDURE


Oncology therapists in a psychosocial oncology center were trained in eSCCIP delivery. Participants were eligible for participation if they were the primary caregiver of a child with cancer between the ages 0 and 17, could read and write in English, and had reliable internet access to complete eSCCIP. Surveys were administered electronically at baseline and post intervention to evaluate study endpoints. Effect sizes (Cohen's d) were computed for exploratory psychosocial outcomes. Nineteen parents completed the intervention.
RESULTS


Parents rated eSCCIP as highly acceptable, feasible, and accessible. A large clinical effect was detected for acute distress (d = 0.79). Moderate clinical effects were reported for overall posttraumatic stress disorder (PTSD) symptoms (d = 0.37), negative mood/cognitions (d = 0.59), and symptoms of anxiety (d = 0.48).
CONCLUSIONS


Results indicate that eSCCIP is an acceptable, feasible, and accessible psychosocial intervention for parents. Exploratory analyses suggest that participation in eSCCIP may contribute to decreases in acute distress, symptoms of anxiety, and symptoms of PTSD.",2022,A large clinical effect was detected for acute distress (,"['parents and caregivers of children with cancer (parents', 'Participants were eligible for participation if they were the primary caregiver of a child with cancer between the ages 0 and 17, could read and write in English, and had reliable internet access to complete eSCCIP', 'parents of children with cancer', 'Nineteen parents completed the intervention']","['psychosocial eHealth intervention', 'eSCCIP', 'Competently Intervention Program ']","['overall posttraumatic stress disorder (PTSD) symptoms ', 'symptoms of anxiety', 'acute distress, symptoms of anxiety, and symptoms of PTSD', 'intervention acceptability, feasibility, and accessibility, with a secondary exploratory focus on psychosocial outcomes', 'negative mood/cognitions', 'acute distress ']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",19.0,0.0726236,A large clinical effect was detected for acute distress (,"[{'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Canter', 'Affiliation': 'Nemours Center for Healthcare Delivery Science, Wilmington, Delaware, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McIntyre', 'Affiliation': 'Inova Schar Cancer Institute, Life with Cancer, Fairfax, Virginia, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Babb', 'Affiliation': 'Inova Schar Cancer Institute, Life with Cancer, Fairfax, Virginia, USA.'}, {'ForeName': 'Alejandra Perez', 'Initials': 'AP', 'LastName': 'Ramirez', 'Affiliation': 'Nemours Center for Healthcare Delivery Science, Wilmington, Delaware, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Vega', 'Affiliation': 'Nemours Center for Healthcare Delivery Science, Wilmington, Delaware, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Nemours Center for Healthcare Delivery Science, Wilmington, Delaware, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Bottrell', 'Affiliation': 'Inova Schar Cancer Institute, Life with Cancer, Fairfax, Virginia, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lawlor', 'Affiliation': 'Center for Cancer and Blood Disorders, Pediatric Specialists of Virginia, Fairfax, Virginia, USA.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Kazak', 'Affiliation': 'Nemours Center for Healthcare Delivery Science, Wilmington, Delaware, USA.'}]",Pediatric blood & cancer,['10.1002/pbc.29352']
952,34532842,Cost Effectiveness of Durvalumab in Unresectable Stage III NSCLC: 4-Year Survival Update and Model Validation from a UK Healthcare Perspective.,"BACKGROUND


In the phase III PACIFIC study, durvalumab improved survival versus placebo in patients with unresectable stage III non-small-cell lung cancer (NSCLC) whose disease had not progressed after platinum-based concurrent chemoradiotherapy. The appraisal by the UK's National Institute for Health and Care Excellence (NICE) included a cost-effectiveness analysis based on an early data readout from PACIFIC [March 2018 data cut-off (DCO); median follow-up duration 25.2 months; range 0.2-43.1]. Uncertainties regarding long-term survival outcomes with durvalumab led to some challenges in estimating the cost effectiveness of this therapy.
OBJECTIVE


Here, we validate the survival extrapolations used in the original company base-case analysis by benchmarking them against updated survival data from the 4-year follow-up analysis of PACIFIC (i.e. approximately 4 years after the last patient was randomised; March 2020 DCO; median follow-up duration 34.2 months; range 0.2-64.9). Moreover, we update the original analysis with these more mature survival data to examine the consistency of key economic outputs with the original analysis.
METHODS


The original analysis used a semi-Markov (state-transition) approach and was based on patients whose tumours expressed programmed cell death-ligand 1 on ≥ 1% of cells (to reflect the European licence for durvalumab). We benchmarked the survival extrapolations used in the original company base-case analysis against survival data from the 4-year follow-up of PACIFIC and updated the cost-effectiveness analysis with these more mature survival data. Early deaths avoided by the adoption of durvalumab into the UK Cancer Drugs Fund (CDF) in March 2019 were estimated using the 4-year follow-up survival data and an assumed uptake of 125 patients/year (lower estimate) and 367 patients/year (higher estimate).
RESULTS


The original company base-case analysis had a good visual fit with the observed overall survival (OS) distribution for the durvalumab arm and accurately predicted the 48-month OS rate (predicted 55%; observed 55%); by comparison, the fit was less precise for the placebo arm, for which the analysis underestimated the 48-month OS rate (predicted 32%; observed 38%). In the updated company base-case analysis, durvalumab yielded 2.51 incremental quality-adjusted life-years (QALYs) (- 0.43 vs. the original company base-case analysis), corresponding to an incremental cost-effectiveness ratio of £22,665/QALY (+£3298 vs. the original analysis), which falls within the upper bound of NICE's willingness-to-pay threshold (£30,000/QALY gained). We estimate that between 31 and 91 early patient deaths may have been avoided by the adoption of durvalumab into the CDF.
CONCLUSIONS


These findings reinforce the patient benefit observed with durvalumab in unresectable stage III NSCLC, support the routine use and cost effectiveness of this therapy, and demonstrate how appropriate modelling can inform the early adoption of therapies by payers to achieve patient benefit.",2022,"The original company base-case analysis had a good visual fit with the observed overall survival (OS) distribution for the durvalumab arm and accurately predicted the 48-month OS rate (predicted 55%; observed 55%); by comparison, the fit was less precise for the placebo arm, for which the analysis underestimated the 48-month OS rate (","['Unresectable Stage III NSCLC', 'patients with unresectable stage III non-small-cell lung cancer (NSCLC) whose disease had not progressed after platinum-based concurrent chemoradiotherapy']","['Durvalumab', 'placebo', 'durvalumab']","['48-month OS rate', 'survival', 'survival extrapolations', 'overall survival (OS) distribution', '48-month OS rate ']","[{'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",,0.21978,"The original company base-case analysis had a good visual fit with the observed overall survival (OS) distribution for the durvalumab arm and accurately predicted the 48-month OS rate (predicted 55%; observed 55%); by comparison, the fit was less precise for the placebo arm, for which the analysis underestimated the 48-month OS rate (","[{'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Dunlop', 'Affiliation': 'AstraZeneca Global Health Economics & Payer Evidence (Oncology), 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA, UK. william.dunlop@astrazeneca.com.'}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'van Keep', 'Affiliation': 'BresMed Netherlands, Utrecht, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Elroy', 'Affiliation': 'BresMed Netherlands, Utrecht, The Netherlands.'}, {'ForeName': 'Ignacio Diaz', 'Initials': 'ID', 'LastName': 'Perez', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Mario J N M', 'Initials': 'MJNM', 'LastName': 'Ouwens', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Sarbajna', 'Affiliation': 'AstraZeneca Global Health Economics & Payer Evidence (Oncology), 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA, UK.'}, {'ForeName': 'Yiduo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Greystoke', 'Affiliation': 'Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}]",PharmacoEconomics - open,['10.1007/s41669-021-00301-7']
953,34534130,Effect of a Multicomponent Sepsis Transition and Recovery Program on Mortality and Readmissions After Sepsis: The Improving Morbidity During Post-Acute Care Transitions for Sepsis Randomized Clinical Trial.,"OBJECTIVES


To evaluate whether a nurse navigator-led, multicomponent Sepsis Transition And Recovery program improves 30-day mortality and readmission outcomes after sepsis hospitalization.
DESIG


n: Multisite pragmatic randomized clinical trial.
SETTING


Three hospitals in North Carolina from January 2019 to March 2020.
PATIENTS


Eligible patients hospitalized for suspected sepsis and deemed high-risk for mortality or readmission by validated internal risk models.
INTERVENTIONS


Patients were randomized to receive usual care alone (i.e., routine transition support, outpatient care; n = 342) or additional Sepsis Transition And Recovery support (n = 349). The 30-day intervention involved a multicomponent transition service led by a nurse navigator through telephone and electronic health record communication to facilitate best practice postsepsis care strategies during and after hospitalization including: postdischarge medication review, evaluation for new impairments or symptoms, monitoring comorbidities, and palliative care approach when appropriate. Clinical oversight was provided by a Hospital Medicine Transition Services team.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was a composite of mortality or hospital readmission at 30 days. Logistic regression models were constructed to evaluate marginal and conditional odds ratios (adjusted for prognostic covariates: age, comorbidity, and organ dysfunction at enrollment). Among 691 randomized patients (mean age = 63.7 ± 15.1 yr; 52% female), a lower percentage of patients in the Sepsis Transition And Recovery group experienced the primary outcome compared with the usual care group (28.7% vs 33.3%; risk difference, 4.7%; odds ratio, 0.80; 95% CI, 0.58-1.11; adjusted odds ratio, 0.80; 95% CI, 0.64-0.98). There were 74 deaths (Sepsis Transition And Recovery: 33 [9.5%] vs usual care: 41 [12.0%]) and 155 rehospitalizations (Sepsis Transition And Recovery: 71 [20.3%] vs usual care: 84 [24.6%]).
CONCLUSIONS


In a multisite randomized clinical trial of patients hospitalized with sepsis, patients provided with a 30-day program using a nurse navigator to provide best practices for postsepsis care experienced a lower proportion of either mortality or rehospitalization within 30 days after discharge. Further research is needed to understand the contextual factors associated with successful implementation.",2022,"vs usual care: 84 [24.6%]).
","['Eligible patients hospitalized for suspected sepsis and deemed high-risk for mortality or readmission by validated internal risk models', 'After Sepsis', 'patients hospitalized with sepsis, patients provided with a 30-day program using a nurse navigator to provide best practices for postsepsis care experienced a lower proportion of either mortality or rehospitalization within 30 days after discharge', '691 randomized patients (mean age = 63.7 ± 15.1 yr; 52% female', 'Three hospitals in North Carolina from January 2019 to March 2020']","['Multicomponent Sepsis Transition and Recovery Program', 'usual care alone (i.e., routine transition support, outpatient care; n = 342) or additional Sepsis Transition And Recovery support', 'nurse navigator-led, multicomponent Sepsis Transition And Recovery program', 'multicomponent transition service led by a nurse navigator through telephone and electronic health record communication to facilitate best practice postsepsis care strategies']","['74 deaths (Sepsis Transition And Recovery', 'Mortality and Readmissions', 'composite of mortality or hospital readmission', '30-day mortality and readmission outcomes', 'Morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",691.0,0.271531,"vs usual care: 84 [24.6%]).
","[{'ForeName': 'Stephanie Parks', 'Initials': 'SP', 'LastName': 'Taylor', 'Affiliation': 'Department of Internal Medicine, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Transition Services, Department of Internal Medicine, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Aleta', 'Initials': 'A', 'LastName': 'Rios', 'Affiliation': 'Ambulatory Care Management, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McWilliams', 'Affiliation': 'Department of Internal Medicine and Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'McCurdy', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Shih-Hsiung', 'Initials': 'SH', 'LastName': 'Chou', 'Affiliation': 'Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hetherington', 'Affiliation': 'Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Rossman', 'Affiliation': 'Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Russo', 'Affiliation': 'Division of Hepatology, Department of Internal Medicine, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gibbs', 'Affiliation': 'Department of Emergency Medicine, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Kowalkowski', 'Affiliation': 'Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, NC.'}]",Critical care medicine,['10.1097/CCM.0000000000005300']
954,34538072,Inhibition of WEE1 Is Effective in  TP53 - and  RAS -Mutant Metastatic Colorectal Cancer: A Randomized Trial (FOCUS4-C) Comparing Adavosertib (AZD1775) With Active Monitoring.,"PURPOSE


Outcomes in  RAS -mutant metastatic colorectal cancer (mCRC) remain poor and patients have limited therapeutic options. Adavosertib is the first small-molecule inhibitor of WEE1 kinase. We hypothesized that aberrations in DNA replication seen in mCRC with both  RAS  and  TP53  mutations would sensitize tumors to WEE1 inhibition.
METHODS


Patients with newly diagnosed mCRC were registered into FOCUS4 and tested for  TP53  and  RAS  mutations. Those with both mutations who were stable or responding after 16 weeks of chemotherapy were randomly assigned 2:1 between adavosertib and active monitoring (AM). Adavosertib (250 mg or 300 mg) was taken orally once on days 1-5 and days 8-12 of a 3-week cycle. The primary outcome was progression-free survival (PFS), with a target hazard ratio (HR) of 0.5 and 80% power with a one-sided 0.025 significance level.
RESULTS


FOCUS4-C was conducted between April 2017 and Mar 2020 during which time 718 patients were registered; 247 (34%) were  RAS/TP53 -mutant. Sixty-nine patients were randomly assigned from 25 UK hospitals (adavosertib = 44; AM = 25). Adavosertib was associated with a PFS improvement over AM (median 3.61  v  1.87 months; HR = 0.35; 95% CI, 0.18 to 0.68;  P  = .0022). Overall survival (OS) was not improved with adavosertib versus AM (median 14.0  v  12.8 months; HR = 0.92; 95% CI, 0.44 to 1.94;  P  = .93). In prespecified subgroup analysis, adavosertib activity was greater in left-sided tumors (HR = 0.24; 95% CI, 0.11 to 0.51), versus right-sided (HR = 1.02; 95% CI, 0.41 to 2.56; interaction  P  = .043). Adavosertib was well-tolerated; grade 3 toxicities were diarrhea (9%), nausea (5%), and neutropenia (7%).
CONCLUSION


In this phase II randomized trial, adavosertib improved PFS compared with AM and demonstrates potential as a well-tolerated therapy for  RAS/TP53 -mutant mCRC. Further testing is required in this sizable population of unmet need.",2021,"Adavosertib was associated with a PFS improvement over AM (median 3.61  v  1.87 months; HR = 0.35; 95% CI, 0.18 to 0.68;  P  = .0022).","['Those with both mutations who were stable or responding after 16 weeks of chemotherapy', '718 patients were registered; 247 (34%) were  RAS/TP53', 'Sixty-nine patients were randomly assigned from 25 UK hospitals (adavosertib = 44; AM = 25', 'Patients with newly diagnosed mCRC were registered into FOCUS4 and tested for  TP53  and  RAS  mutations', 'RAS -mutant metastatic colorectal cancer (mCRC', 'Metastatic Colorectal Cancer']","['adavosertib and active monitoring (AM', 'Adavosertib', 'FOCUS4-C']","['PFS improvement over AM', 'neutropenia', 'tolerated; grade 3 toxicities were diarrhea', 'adavosertib activity', 'progression-free survival (PFS), with a target hazard ratio (HR', 'Overall survival (OS', 'nausea']","[{'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0034678', 'cui_str': 'ras Oncogene'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C1531698', 'cui_str': 'Active monitoring'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",69.0,0.27701,"Adavosertib was associated with a PFS improvement over AM (median 3.61  v  1.87 months; HR = 0.35; 95% CI, 0.18 to 0.68;  P  = .0022).","[{'ForeName': 'Jenny F', 'Initials': 'JF', 'LastName': 'Seligmann', 'Affiliation': 'Leeds Institute of Medical Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Fisher', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Louise C', 'Initials': 'LC', 'LastName': 'Brown', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Adams', 'Affiliation': 'Centre for Trials Research University and Velindre NHS Trust, Cardiff, United Kingdom.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': 'Beatson Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Quirke', 'Affiliation': 'Leeds Institute of Medical Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Richman', 'Affiliation': 'Leeds Institute of Medical Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Butler', 'Affiliation': 'Bristol Genetics Laboratory, Bristol, United Kingdom.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Domingo', 'Affiliation': 'MRC Oxford Institute for Radiation Oncology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blake', 'Affiliation': 'MRC Oxford Institute for Radiation Oncology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Yates', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Braun', 'Affiliation': 'Christie Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Collinson', 'Affiliation': 'Leeds Institute of Medical Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Brown', 'Affiliation': 'Western General Hospital, Edinburgh, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'de Winton', 'Affiliation': 'Royal United Hospital, Bath, United Kingdom.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Humphrey', 'Affiliation': 'MRC Oxford Institute for Radiation Oncology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Wilson', 'Affiliation': 'Beatson Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Seymour', 'Affiliation': 'Leeds Institute of Medical Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Maughan', 'Affiliation': 'MRC Oxford Institute for Radiation Oncology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.01435']
955,34539455,"A ""Proof of Concept"" Randomized Controlled Trial of a Video Game Requiring Emotional Regulation to Augment Anger Control Training.","Emotional dysregulation leading to clinically significant anger and aggression is a common and substantial concern for youth and their families. While psychotropic medications and cognitive behavioral therapies can be effective, these modalities suffer from drawbacks such as significant side effects, high rates of attrition, and lack of real-world skill translation.  R egulate  a nd  G ain  E motional Control (RAGE-Control) is a video game designed as an engaging augment to existing treatments. The game facilitates emotional regulation skill building through practice modulating physiological arousal while completing a challenging inhibitory task. We compared reduction in anger, aggression, oppositionality, and global severity between two treatment conditions: Anger Control Training (ACT) augmented with RAGE-Control and ACT with a sham version of the game, in a pilot double-blind randomized controlled trial. To begin to understand mechanisms of change, we examined heart rate during game play over the course of the study and explored associations between symptom changes and heart rate changes.  Materials and Methods:  Forty youth with clinically significant anger dyscontrol (age 10-17) were randomly assigned to 10 sessions of ACT with RAGE-Control or ACT with sham video game.  Results:  Both treatments similarly reduced self-reported anger. However, ACT with RAGE-Control led to larger improvements in aggression (CI: -17 to -1.0, ES: 0.55,  p  = 0.015); oppositionality (CI: -9.0 to -7e-6, ES: 0.48,  p  = 0.032); and global severity (CI: -1.0 to -5e-6, ES: 0.51,  p  = 0.023) relative to sham. Participants in the RAGE-Control group saw a decrease in median heart rate during game play (β = 1.2,  p  < 0.001). Larger pre to post decreases in heart rate were significantly associated with larger pre to post decreases in aggression and oppositional behaviors.  Discussion:  Augmenting ACT with RAGE-Control reduced behavioral expression of anger, but not the experience of angry feelings, as compared to ACT with a sham version of the game. Increased heart rate control, demonstrated by reduction in median heart rate during gameplay, was associated with decreased aggression and oppositional behavior. Together these findings support that augmenting traditional treatment with technology facilitating heart rate control through skill practice translates to enhancements in real-life behavioral change. Therefore, further exploration into engaging skill-focused games such as RAGE-Control is warranted.  Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT01551732.",2021,Larger pre to post decreases in heart rate were significantly associated with larger pre to post decreases in aggression and oppositional behaviors.  ,['Forty youth with clinically significant anger dyscontrol (age 10-17'],"['Video Game Requiring Emotional Regulation to Augment Anger Control Training', 'ACT with RAGE-Control or ACT with sham video game', 'Anger Control Training (ACT) augmented with RAGE-Control and ACT with a sham version of the game']","['global severity', 'aggression', 'heart rate control', 'heart rate', 'aggression and oppositional behaviors', 'behavioral expression of anger', 'anger, aggression, oppositionality, and global severity', 'aggression and oppositional behavior', 'median heart rate']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0034634', 'cui_str': 'Rage'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C1959585', 'cui_str': 'Heart Rate Control'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",40.0,0.200405,Larger pre to post decreases in heart rate were significantly associated with larger pre to post decreases in aggression and oppositional behaviors.  ,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ducharme', 'Affiliation': ""Department of Psychiatry, Boston Children's Hospital, Boston, MA, United States.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Kahn', 'Affiliation': ""Department of Psychiatry, Boston Children's Hospital, Boston, MA, United States.""}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Vaudreuil', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Gusman', 'Affiliation': ""Department of Psychiatry, Boston Children's Hospital, Boston, MA, United States.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Waber', 'Affiliation': ""Department of Psychiatry, Boston Children's Hospital, Boston, MA, United States.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Ross', 'Affiliation': ""Department of Psychiatry, Boston Children's Hospital, Boston, MA, United States.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rotenberg', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Boston, MA, United States.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Rober', 'Affiliation': ""Department of Psychiatry, Boston Children's Hospital, Boston, MA, United States.""}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Kimball', 'Affiliation': ""Department of Psychiatry, Boston Children's Hospital, Boston, MA, United States.""}, {'ForeName': 'Alyssa L', 'Initials': 'AL', 'LastName': 'Peechatka', 'Affiliation': 'Neuromotion Labs, Boston, MA, United States.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Gonzalez-Heydrich', 'Affiliation': ""Department of Psychiatry, Boston Children's Hospital, Boston, MA, United States.""}]",Frontiers in psychiatry,['10.3389/fpsyt.2021.591906']
956,34543417,Nonadherence to Ledipasvir/Sofosbuvir Did Not Predict Sustained Virologic Response in a Randomized Controlled Trial of Human Immunodeficiency Virus/Hepatitis C Virus Coinfected Persons Who Use Drugs.,"BACKGROUND


Eliminating hepatitis C virus (HCV) will require effective treatment delivery to persons with substance use disorders (SUDs). We evaluated the relationship between ledipasvir/sofosbuvir treatment persistence (receiving 84 tablets), adherence, and sustained virologic response (SVR) in persons with human immunodeficiency virus (HIV)/HCV coinfection.
METHODS


Of the 144 participants with HIV/HCV and SUDs, 110 initiated a 12-week treatment course under 1 of 3 conditions (usual care, peer mentors, and cash incentives). We used self-report, pharmacy pill counts, and expected date of refill to examine adherence. Persistent participants were categorized as high adherence (taking ≥90% of doses) or low adherence (taking <90% of doses).
RESULTS


Most participants persisted on treatment after initiation (n = 105), with 95% (n = 100) achieving SVR. One third (34%) of participants had moderate/heavy alcohol use by the biomarker phosphatidylethanol ([Peth] ≥50 ng/mL), and 44% had urine toxicology positive for cocaine or heroin at enrollment. The proportion of persons with high adherence was 72% (n = 76), and the proportion of persons with low adherence was 28%. Although low adherence was associated with moderate/heavy alcohol use by PEth (relative risk = 2.77; 95% confidence interval, 1.50-5.12), SVR did not vary according to adherence (P = .702), and most participants (97%) with low adherence achieved SVR.
CONCLUSIONS


Treatment persistence led to high SVR rates among persons with HIV/HCV, despite imperfect adherence and SUDs.",2022,"Although low adherence was associated with moderate/heavy alcohol use by PEth (RR 2.77, 95% CI 1.50-5.12), SVR did not vary according to adherence (p=0.702), and most participants (97%) with low adherence achieved SVR.
","['persons with substance use disorders (SUDs', 'persons with HIV/HCV coinfection', 'Of the 144 participants with HIV/HCV and SUDs']","['LDV/SOF', 'Hepatitis C Virus (HCV', 'phosphatidylethanol']","['SVR', 'SVR rates', 'proportion of persons with high adherence', 'urine toxicology positive', 'adherence, and sustained virologic response (SVR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0070787', 'cui_str': 'Phosphatidylethanol'}]","[{'cui': 'C4050171', 'cui_str': 'Sustained Viral Suppression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0040541', 'cui_str': 'Toxicology'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}]",144.0,0.0328542,"Although low adherence was associated with moderate/heavy alcohol use by PEth (RR 2.77, 95% CI 1.50-5.12), SVR did not vary according to adherence (p=0.702), and most participants (97%) with low adherence achieved SVR.
","[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Ward', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Oluwaseun', 'Initials': 'O', 'LastName': 'Falade-Nwulia', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Juhi', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Catherine G', 'Initials': 'CG', 'LastName': 'Sutcliffe', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Sherilyn', 'Initials': 'S', 'LastName': 'Brinkley', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Haselhuhn', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Katz', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Herne', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Arteaga', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Shruti H', 'Initials': 'SH', 'LastName': 'Mehta', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Latkin', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Brooner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Sulkowski', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiab477']
957,34551936,The Deterrence of Rapid Metabolic Decline Within 3 Months After Teplizumab Treatment in Individuals at High Risk for Type 1 Diabetes.,"End points that provide an early identification of treatment effects are needed to implement type 1 diabetes prevention trials more efficiently. To this end, we assessed whether metabolic end points can be used to detect a teplizumab effect on rapid β-cell decline within 3 months after treatment in high-risk individuals in the TrialNet teplizumab trial. Glucose and C-peptide response curves (GCRCs) were constructed by plotting mean glucose and C-peptide values from 2-h oral glucose tolerance tests on a two-dimensional grid. Groups were compared visually for changes in GCRC shape and movement. GCRC changes reflected marked metabolic deterioration in the placebo group within 3 months of randomization. By 6 months, GCRCs resembled typical GCRCs at diagnosis. In contrast, GCRC changes in the teplizumab group suggested metabolic improvement. Quantitative comparisons, including two novel metabolic end points that indicate GCRC changes, the within-quadrant end point and the ordinal directional end point, were consistent with visual impressions of an appreciable treatment effect at the 3- and 6-month time points. In conclusion, an analytic approach combining visual evidence with novel end points demonstrated that teplizumab delays rapid metabolic decline and improves the metabolic state within 3 months after treatment; this effect extends for at least 6 months.",2021,GCRC changes reflected marked metabolic deterioration in the placebo group within 3 months of randomization.,"['high-risk individuals in the TrialNet teplizumab trial', 'Individuals at High Risk for Type 1 Diabetes']","['placebo', 'Teplizumab']","['Glucose and C-peptide response curves (GCRCs', 'metabolic state', 'metabolic improvement', 'metabolic deterioration', 'GCRC changes, the Within Quadrant Endpoint (WQE) and the Ordinal Directional Endpoint (ODE']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2743673', 'cui_str': 'teplizumab'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2743673', 'cui_str': 'teplizumab'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}]",,0.109294,GCRC changes reflected marked metabolic deterioration in the placebo group within 3 months of randomization.,"[{'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Sims', 'Affiliation': 'Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN eksims@iu.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cuthbertson', 'Affiliation': 'Department of Pediatrics, Pediatrics Epidemiology Center, Morsani College of Medicine, University of South Florida, Tampa, FL.'}, {'ForeName': 'Kevan C', 'Initials': 'KC', 'LastName': 'Herold', 'Affiliation': 'Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Sosenko', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL.'}]",Diabetes,['10.2337/db21-0519']
958,34551902,Arthroscopic Bankart versus open Latarjet as a primary operative treatment for traumatic anteroinferior instability in young males: a randomised controlled trial with 2-year follow-up.,"OBJECTIVES


To compare the success rates of arthroscopic Bankart and open Latarjet procedure in the treatment of traumatic shoulder instability in young males.
DESIGN


Multicentre randomised controlled trial.
SETTING


Orthopaedic departments in eight public hospitals in Finland.
PARTICIPANTS


122 young males, mean age 21 years (range 16-25 years) with traumatic shoulder anteroinferior instability were randomised.
INTERVENTIONS


Arthroscopic Bankart (group B) or open Latarjet (group L) procedure.
MAIN OUTCOME MEASURES


The primary outcome measure was the reported recurrence of instability, that is, dislocation at 2-year follow-up. The secondary outcome measures included clinical apprehension, sports activity level, the Western Ontario Shoulder Instability Index, the pain Visual Analogue Scale, the Oxford Shoulder Instability Score, the Constant Score and the Subjective Shoulder Value scores and the progression of osteoarthritic changes in plain films and MRI.
RESULTS


91 patients were available for analyses at 2-year follow-up (drop-out rate 25%). There were 10 (21%) patients with redislocations in group B and 1 (2%) in group L, p=0.006. One (9%) patient in group B and five (56%) patients in group L returned to their previous top level of competitive sports (p=0.004) at follow-up. There was no statistically significant between group differences in any of the other secondary outcome measures.
CONCLUSIONS


Arthroscopic Bankart operation carries a significant risk for short-term postoperative redislocations compared with open Latarjet operation, in the treatment of traumatic anteroinferior instability in young males. Patients should be counselled accordingly before deciding the surgical treatment.
TRIAL REGISTRATION NUMBER


NCT01998048.",2022,"There was no statistically significant between group differences in any of the other secondary outcome measures.
","['122 young males, mean age 21 years (range 16-25 years) with traumatic shoulder anteroinferior instability were randomised', 'young males', 'Orthopaedic departments in eight public hospitals in Finland']","['arthroscopic Bankart and open Latarjet procedure', 'Arthroscopic Bankart (group B) or open Latarjet (group L) procedure', 'Arthroscopic Bankart operation', 'Arthroscopic Bankart versus open Latarjet']","['clinical apprehension, sports activity level, the Western Ontario Shoulder Instability Index, the pain Visual Analogue Scale, the Oxford Shoulder Instability Score, the Constant Score and the Subjective Shoulder Value scores and the progression of osteoarthritic changes in plain films and MRI', 'reported recurrence of instability, that is, dislocation at 2-year follow-up']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3697075', 'cui_str': 'Latarjet procedure'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441846', 'cui_str': 'Group L'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0233485', 'cui_str': 'Apprehension'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",122.0,0.0994086,"There was no statistically significant between group differences in any of the other secondary outcome measures.
","[{'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Kukkonen', 'Affiliation': 'Orthopaedics and Traumatology, Turku University Hospital, Turku, Finland jupeku@utu.fi.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elamo', 'Affiliation': 'Surgery, Division of Orthopaedic and Trauma Surgery, Satakunta Central Hospital, Pori, Finland.'}, {'ForeName': 'Tapio', 'Initials': 'T', 'LastName': 'Flinkkilä', 'Affiliation': 'Surgery, Division of Orthopaedic and Trauma Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Paloneva', 'Affiliation': 'Orthopaedics and Traumatology, Central Finland Central Hospital, Jyvaskyla, Finland.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Mäntysaari', 'Affiliation': 'Orthopaedics and Traumatology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Joukainen', 'Affiliation': 'Orthopaedics and Traumatology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Lehtinen', 'Affiliation': 'Orthopaedic Unit, Tays Hatanpää Hospital, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Lepola', 'Affiliation': 'Pohjola Hospital Tampere, Tampere, Finland.'}, {'ForeName': 'Milja', 'Initials': 'M', 'LastName': 'Holstila', 'Affiliation': 'Department of Radiology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Kauko', 'Affiliation': 'Auria Clinical Informatics, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Aarimaa', 'Affiliation': 'Orthopaedics and Traumatology, Turku University Hospital, Turku, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of sports medicine,['10.1136/bjsports-2021-104028']
959,34534319,Influence of Preseason Antibodies Against Influenza Virus on Risk of Influenza Infection Among Healthcare Personnel.,"BACKGROUND


The association of hemagglutination inhibition (HAI) antibodies with protection from influenza among healthcare personnel (HCP) with occupational exposure to influenza viruses has not been well-described.
METHODS


The Respiratory Protection Effectiveness Clinical Trial was a cluster-randomized, multisite study that compared medical masks to N95 respirators in preventing viral respiratory infections among HCP in outpatient healthcare settings for 5180 participant-seasons. Serum HAI antibody titers before each influenza season and influenza virus infection confirmed by polymerase chain reaction were studied over 4 study years.
RESULTS


In univariate models, the risk of influenza A(H3N2) and B virus infections was associated with HAI titers to each virus, study year, and site. HAI titers were strongly associated with vaccination. Within multivariate models, each log base 2 increase in titer was associated with 15%, 26% and 33%-35% reductions in the hazard of influenza A(H3N2), A(H1N1), and B infections, respectively. Best models included preseason antibody titers and study year, but not other variables.
CONCLUSIONS


HAI titers were associated with protection from influenza among HCP with routine exposure to patients with respiratory illness and influenza season contributed to risk. HCP can be reassured about receiving influenza vaccination to stimulate immunity.",2022,"CONCLUSIONS


HAI titers were associated with protection from influenza among HCP with routine exposure to patients with respiratory illness and influenza season contributed to risk.","['5,180 participant-seasons', 'Health Care Personnel']",['HCP'],"['Serum HAI antibody titers', 'HAI titers']","[{'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",,0.055707,"CONCLUSIONS


HAI titers were associated with protection from influenza among HCP with routine exposure to patients with respiratory illness and influenza season contributed to risk.","[{'ForeName': 'Geoffrey J', 'Initials': 'GJ', 'LastName': 'Gorse', 'Affiliation': 'Section of Infectious Diseases, Veterans Affairs St Louis Health Care System, St Louis, Missouri, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Rattigan', 'Affiliation': 'Department of Biology and the Emerging Pathogens Institute, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kirpich', 'Affiliation': 'Department of Population Health Sciences, School of Public Health, Georgia State University, Atlanta, Georgia, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Simberkoff', 'Affiliation': 'Department of Medicine, Veterans Affairs New York Harbor Healthcare System, New York, New York, USA.'}, {'ForeName': 'Mary T', 'Initials': 'MT', 'LastName': 'Bessesen', 'Affiliation': 'Veterans Affairs Eastern Colorado Healthcare System, Aurora, Colorado, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Gibert', 'Affiliation': 'Medical Service, Washington DC Veterans Affairs Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Ann-Christine', 'Initials': 'AC', 'LastName': 'Nyquist', 'Affiliation': 'Division of Infectious Diseases, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Connie Savor', 'Initials': 'CS', 'LastName': 'Price', 'Affiliation': 'Division of Infectious Diseases, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Gaydos', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Radonovich', 'Affiliation': 'Respiratory Health Division, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Morgantown, West Virginia, USA.'}, {'ForeName': 'Trish M', 'Initials': 'TM', 'LastName': 'Perl', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Rodriguez-Barradas', 'Affiliation': 'Infectious Diseases Section, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA.'}, {'ForeName': 'Derek A T', 'Initials': 'DAT', 'LastName': 'Cummings', 'Affiliation': 'Department of Biology and the Emerging Pathogens Institute, University of Florida, Gainesville, Florida, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiab468']
960,34546534,"Pharmacokinetics, Pharmacodynamics, and Tolerability of AZD5718, an Oral 5-Lipoxygenase-Activating Protein (FLAP) Inhibitor, in Healthy Japanese Male Subjects.","BACKGROUND AND OBJECTIVE


AZD5718, a 5-lipoxygenase-activating protein (FLAP) inhibitor, is in clinical development for treatment of coronary artery disease (CAD) and chronic kidney disease (CKD). This study evaluated AZD5718 pharmacokinetics, pharmacodynamics, and tolerability in healthy male Japanese subjects.
METHODS


Four cohorts of eight Japanese subjects were randomized to receive oral doses of AZD5718 (60, 180, 360, and 600 mg) or matching placebo administered as a single dose on Day 1 and as once-daily doses from Day 3 to Day 10 in fasted conditions. Pharmacokinetic, pharmacodynamic, and safety data were collected.
RESULTS


The pharmacokinetics characteristics of AZD5718 in Japanese male subjects were similar to those reported in a previous study, and the pharmacokinetics were characterized as rapid absorption with median time to reach maximum concentration (T max ) of 1-2 h Creatine-normalized urine maximum concentration (C max ) with mean half-lives ranging from 8 to 21 h, and supra-proportional increase in exposure over the 60-600 mg dose range evaluated. Also, an increase in steady-state area under the concentration-time curve (AUC) compared to the first dose was observed. After both single and multiple doses of AZD5718, a clear dose/concentration-effect relationship was shown for urinary leukotriene E 4  (LTE 4 ) versus AZD5718 exposure with > 80 % inhibition at plasma concentrations in the lower nM range. No clinically relevant safety and tolerability findings were observed.
CONCLUSIONS


The observed pharmacokinetics and pharmacodynamics were similar to reported data for non-Japanese healthy subjects, which support further evaluation of AZD5718 at similar doses/exposures in Japanese and non-Japanese subjects for future evaluation in patients with CAD and CKD.",2021,"No clinically relevant safety and tolerability findings were observed.
","['Japanese male subjects', 'healthy male Japanese subjects', 'Healthy Japanese Male Subjects', 'Four cohorts of eight Japanese subjects', 'Japanese healthy subjects', 'coronary artery disease (CAD) and chronic kidney disease (CKD']","['AZD5718', '5-lipoxygenase-activating protein (FLAP) inhibitor', 'matching placebo', 'AZD5718, an Oral 5-Lipoxygenase-Activating Protein (FLAP) Inhibitor']","['rapid absorption with median\xa0time to reach maximum concentration (T max )\xa0of 1-2 h Creatine-normalized urine maximum concentration (C max ', 'steady-state area under the concentration-time curve (AUC', 'Pharmacokinetics, Pharmacodynamics, and Tolerability', 'Pharmacokinetic, pharmacodynamic, and safety data']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C5198148', 'cui_str': 'AZD5718'}, {'cui': 'C2936593', 'cui_str': 'FLAP Inhibitors'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0361266,"No clinically relevant safety and tolerability findings were observed.
","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Knöchel', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Pepparedsleden 1, Mölndal, 431 83, Gothenburg, Sweden. jane.knochel@astrazeneca.com.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Nelander', 'Affiliation': 'Early Biometrics and Statistical Innovation, Data Science and AI, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Heijer', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Pepparedsleden 1, Mölndal, 431 83, Gothenburg, Sweden.'}, {'ForeName': 'Eva-Lotte', 'Initials': 'EL', 'LastName': 'Lindstedt', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Gun-Britt', 'Initials': 'GB', 'LastName': 'Forsberg', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Whatling', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Shimada', 'Affiliation': 'Science Enablement, Science and Data Analytics, Japan R&D, AstraZeneca, Osaka, Japan.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Han', 'Affiliation': 'PAREXEL Early Phase Clinical Unit, Los Angeles, CA, USA.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Gabrielsen', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Pavlo', 'Initials': 'P', 'LastName': 'Garkaviy', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Ericsson', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Pepparedsleden 1, Mölndal, 431 83, Gothenburg, Sweden.'}]",Clinical drug investigation,['10.1007/s40261-021-01078-7']
961,34546914,Longitudinal Outcomes of a Smartphone Application to Prevent Drug Use Among Hispanic Youth.,"OBJECTIVE


This trial tested the efficacy of a smartphone application (app) designed to prevent drug use among Hispanic youth.
METHOD


Participants were recruited through online advertising and youth service agencies. The baseline sample ( N  = 644) had a mean age of 14.1 years, was primarily female (60%), and resided in 31 U.S. states and Puerto Rico. Youth assented to study participation and received parental permission to participate. Youth were randomly assigned to an intervention arm or a measurement-only control arm. Intervention-arm youth completed 10 prevention program sessions via a smartphone app. Following intervention delivery, all youth completed posttest and 1-, 2-, and 3-year follow-up measures.
RESULTS


Analyzed within an Arm by Time interaction model, follow-up data showed that compared with control-arm youth, intervention-arm youth reported (a) less increase in alcohol use from baseline to 2-year follow-up; (b) less increase in marijuana use from baseline to 2- and 3-year follow-ups; and (c) less increase in polydrug use from baseline to 1-, 2-, and 3-year follow-ups. Compared with youth in the control arm, intervention-arm youth reported (a) less depressed mood and improved skills for refusing offers of alcohol and tobacco at posttest; (b) higher self-efficacy and social self-efficacy at 1-, 2-, and 3-year follow-ups; (c) improved skills for refusing offers of marijuana at 2- and 3-year follow-ups; (d) higher media literacy at 2- and 3-year follow-ups; and (e) better coping skills at 3-year follow-up.
CONCLUSIONS


These longitudinal findings suggest that Hispanic youth can profit from tailored, skills-based content delivered via a smartphone app to prevent drug use.",2021,"Compared with youth in the control arm, intervention-arm youth reported (a) less depressed mood and improved skills for refusing offers of alcohol and tobacco at posttest; (b) higher self-efficacy and social self-efficacy at 1-, 2-, and 3-year follow-ups; (c) improved skills for refusing offers of marijuana at 2- and 3-year follow-ups; (d) higher media literacy at 2- and 3-year follow-ups; and (e) better coping skills at 3-year follow-up.
","['Participants were recruited through online advertising and youth service agencies', 'Hispanic Youth', 'Hispanic youth', 'The baseline sample ( N  = 644) had a mean age of 14.1 years, was primarily female (60%), and resided in 31 U.S. states and Puerto Rico']","['Smartphone Application', 'Intervention-arm youth completed 10 prevention program sessions via a smartphone app', 'smartphone application (app']",['self-efficacy and social self-efficacy'],"[{'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0188754,"Compared with youth in the control arm, intervention-arm youth reported (a) less depressed mood and improved skills for refusing offers of alcohol and tobacco at posttest; (b) higher self-efficacy and social self-efficacy at 1-, 2-, and 3-year follow-ups; (c) improved skills for refusing offers of marijuana at 2- and 3-year follow-ups; (d) higher media literacy at 2- and 3-year follow-ups; and (e) better coping skills at 3-year follow-up.
","[{'ForeName': 'Traci M', 'Initials': 'TM', 'LastName': 'Schwinn', 'Affiliation': 'Columbia School of Social Work, New York, New York.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hopkins', 'Affiliation': 'Catalyst Advisors, New York, New York.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Pacheco', 'Affiliation': 'Columbia School of Social Work, New York, New York.'}]",Journal of studies on alcohol and drugs,[]
962,34558312,Thromboprophylaxis for Children Post-Fontan Procedure: Insights From the UNIVERSE Study.,"Background Patients with single-ventricle physiology who undergo the Fontan procedure are at risk for thrombotic events associated with significant morbidity and mortality. The UNIVERSE Study evaluated the efficacy and safety of a novel liquid rivaroxaban formulation, using a body weight-adjusted dosing regimen, versus acetylsalicylic acid (ASA) in children post-Fontan. Methods and Results The UNIVERSE Study was a randomized, multicenter, 2-part, open-label study of rivaroxaban, in children who had undergone a Fontan procedure, to evaluate its dosing regimen, safety, and efficacy. Part A was the single-arm part of the study that determined the pharmacokinetics/pharmacodynamics and safety of rivaroxaban in 12 participants before proceeding to part B, whereby 100 participants were randomized 2:1 to open-label rivaroxaban versus ASA. The study period was 12 months. A total of 112 participants were enrolled across 35 sites in 10 countries. In part B, for safety outcomes, major bleeding occurred in one participant on rivaroxaban (epistaxis that required transfusion). Clinically relevant nonmajor bleeding occurred in 6% of participants on rivaroxaban versus 9% on ASA. Trivial bleeding occurred in 33% of participants on rivaroxaban versus 35% on ASA. For efficacy outcomes, 1 participant on rivaroxaban in part B had a pulmonary embolism (2% overall event rate); and for ASA, 1 participant had ischemic stroke and 2 had venous thrombosis (9% overall event rate). Conclusions In this study, participants who received rivaroxaban for thromboprophylaxis had a similar safety profile and fewer thrombotic events, albeit not statistically significant, compared with those in the ASA group. Registration URL: https://www.clinicaltrials.gov. Identifier: NCT02846532.",2021,"In this study, participants who received rivaroxaban for thromboprophylaxis had a similar safety profile and fewer thrombotic events, albeit not statistically significant, compared with those in the ASA group.","['children who had undergone a Fontan procedure, to evaluate its dosing regimen, safety, and efficacy', '12 participants before proceeding to part B, whereby 100 participants', 'Children Post-Fontan Procedure', '112 participants were enrolled across 35 sites in 10 countries', 'children post-Fontan']","['open-label rivaroxaban versus ASA', 'Thromboprophylaxis', 'rivaroxaban', 'novel liquid rivaroxaban formulation', 'acetylsalicylic acid (ASA']","['morbidity and mortality', 'thrombotic events', 'nonmajor bleeding', 'safety outcomes, major bleeding', 'Trivial bleeding', 'pulmonary embolism', 'efficacy and safety', 'ischemic stroke and 2 had venous thrombosis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0190010', 'cui_str': 'Fontan procedure'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}]",112.0,0.14935,"In this study, participants who received rivaroxaban for thromboprophylaxis had a similar safety profile and fewer thrombotic events, albeit not statistically significant, compared with those in the ASA group.","[{'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'McCrindle', 'Affiliation': 'The Hospital for Sick Children University of Toronto Toronto ON Canada.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Michelson', 'Affiliation': ""Boston Children's HospitalHarvard Medical School Boston MA.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Van Bergen', 'Affiliation': ""Advocate Children's Hospital Oak Lawn IL.""}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Suzana Horowitz', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology Porto Alegre Brazil.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Pablo Sandoval', 'Affiliation': 'National Institute of Cardiology Mexico City Mexico.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Justino', 'Affiliation': ""Rady Children's Hospital San Diego CA.""}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Harris', 'Affiliation': ""Children's Heart CentreBC Children's Hospital Vancouver BC Canada.""}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Jefferies', 'Affiliation': 'The Cardiac Institute University of Tennessee Health Science Center Memphis TN.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Miriam Pina', 'Affiliation': 'Janssen Research and Development, LLC Raritan NJ.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Peluso', 'Affiliation': 'Janssen Research and Development, LLC Raritan NJ.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Nessel', 'Affiliation': 'Janssen Research and Development, LLC Raritan NJ.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Janssen Research and Development, LLC Raritan NJ.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Duke University Medical Center Durham NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.120.021765']
963,34544660,Community pharmacy technicians' engagement in the delivery of brief tobacco cessation interventions: Results of a randomized trial.,"BACKGROUND


In recent years, the role of community pharmacy technicians has expanded to include involvement in the provision of brief tobacco cessation interventions. While technicians appear to be a key component in this service, their level of engagement and associated perceptions of this new role have not been described.
OBJECTIVE


To compare pharmacy technicians' frequency of involvement in brief tobacco cessation interventions delivered in a community pharmacy setting, as a function of training approach, and to characterize their perceptions of this expanded role, including barriers to implementation.
METHODS


Twenty California-based grocery store chain pharmacies were randomized to receive (a) written training materials-only [minimal] or (b) written training materials plus live training with coaching and active monitoring by pharmacy management [intensive]. After written materials were distributed to the sites, tobacco cessation interventions were documented prospectively for 12 weeks post-training.
RESULTS


Over the 12-week study, technicians (n = 50) documented their involvement in 524 interventions (57.7% of 908 total), with the minimal group accounting for 56.1% and the intensive group accounting for 43.9% (p < 0.001). The number of individual technicians who reported at least one intervention was 16 (of 26; 61.5%) in the minimal group and 24 (of 24; 100%) in the intensive group (p < 0.001). At the conclusion of the study, 100% of technicians in the intensive group self-rated their ability to interact with patients about quitting smoking as good, very good, or excellent compared to 73.9% in the minimal group (p = 0.10).
CONCLUSION


In both study arms, technicians documented high numbers of tobacco cessation interventions. The higher proportion of technicians providing one or more interventions in the intensive group suggests a greater overall engagement in the process, relative to those receiving minimal training. Technicians can play a key role in the delivery of tobacco cessation interventions in community pharmacies.",2021,"The higher proportion of technicians providing one or more interventions in the intensive group suggests a greater overall engagement in the process, relative to those receiving minimal training.","['Twenty California-based grocery store chain pharmacies', 'community pharmacies']","['written training materials-only [minimal] or (b) written training materials plus live training with coaching and active monitoring by pharmacy management [intensive', 'tobacco cessation interventions']",['number of individual technicians'],"[{'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1531698', 'cui_str': 'Active monitoring'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",,0.0315385,"The higher proportion of technicians providing one or more interventions in the intensive group suggests a greater overall engagement in the process, relative to those receiving minimal training.","[{'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Corelli', 'Affiliation': 'University of California, San Francisco School of Pharmacy, San Francisco, CA 94143, USA. Electronic address: robin.corelli@ucsf.edu.'}, {'ForeName': 'Kyle R', 'Initials': 'KR', 'LastName': 'Merchant', 'Affiliation': 'University of California, San Francisco School of Pharmacy, San Francisco, CA 94143, USA.'}, {'ForeName': 'Katy Ellis', 'Initials': 'KE', 'LastName': 'Hilts', 'Affiliation': 'Indiana University School of Nursing, Indianapolis, IN 46202, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kroon', 'Affiliation': 'University of California, San Francisco School of Pharmacy, San Francisco, CA 94143, USA.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Vatanka', 'Affiliation': 'University of California, San Francisco School of Pharmacy, San Francisco, CA 94143, USA; American Pharmacists Association, Washington DC, 20037, USA.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Hille', 'Affiliation': 'Albertsons Companies, Boise, ID 83706, USA.'}, {'ForeName': 'Karen Suchanek', 'Initials': 'KS', 'LastName': 'Hudmon', 'Affiliation': 'University of California, San Francisco School of Pharmacy, San Francisco, CA 94143, USA; Purdue University College of Pharmacy, Indianapolis, IN 46202, USA.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2021.09.001']
964,34545626,Test-retest reliability of the Epworth Sleepiness Scale in clinical trial settings.,"The present analysis examined the test-retest reliability of the Epworth Sleepiness Scale in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea in three clinical trials. Intraclass correlation coefficient estimates for Epworth Sleepiness Scale scores from two solriamfetol 12-week placebo-controlled trials (one narcolepsy, one obstructive sleep apnea) and one long-term open-label extension trial (narcolepsy or obstructive sleep apnea) were calculated using postbaseline time-point pairs for the overall population in each trial, by treatment, and by primary obstructive sleep apnea therapy adherence. In the 12-week narcolepsy trial, intraclass correlation coefficients (95% confidence intervals) were 0.83 (0.79, 0.87) for weeks 4 and 8 (n = 199), 0.87 (0.83, 0.90) for weeks 8 and 12 (n = 196), and 0.81 (0.76, 0.85) for weeks 4 and 12 (n = 196). In the 12-week obstructive sleep apnea trial, intraclass correlation coefficients (95% confidence intervals) were 0.74 (0.69, 0.78) (n = 416), 0.80 (0.76, 0.83) (n = 405), and 0.74 (0.69, 0.78) (n = 405), respectively. In the open-label extension trial, intraclass correlation coefficients (95% confidence intervals) were 0.82 (0.79, 0.85) for weeks 14 and 26/27 (n = 495), 0.85 (0.82, 0.87) for weeks 26/27 and 39/40 (n = 463), and 0.78 (0.74, 0.81) for weeks 14 and 39/40 (n = 463). Placebo/solriamfetol treatment or adherence to primary obstructive sleep apnea therapy did not affect reliability. In conclusion, across three large clinical trials of participants with narcolepsy or obstructive sleep apnea, Epworth Sleepiness Scale scores demonstrated a robust acceptable level of test-retest reliability in evaluating treatment response over time.",2022,"In the 12-week narcolepsy trial, intraclass correlation coefficients (95% confidence intervals) were 0.83 (0.79, 0.87) for weeks 4 and 8 (n = 199),",['participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea in three clinical trials'],['Placebo/solriamfetol'],"['narcolepsy or obstructive sleep apnea, Epworth Sleepiness Scale scores', 'Epworth Sleepiness Scale scores']","[{'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4726765', 'cui_str': 'Solriamfetol'}]","[{'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C4706348', 'cui_str': 'ESS (Epworth Sleepiness Scale) score'}]",,0.160902,"In the 12-week narcolepsy trial, intraclass correlation coefficients (95% confidence intervals) were 0.83 (0.79, 0.87) for weeks 4 and 8 (n = 199),","[{'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Rosenberg', 'Affiliation': 'NeuroTrials Research, Atlanta, GA, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Babson', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Menno', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Baladi', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hyman', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Black', 'Affiliation': 'Stanford Center for Sleep Sciences and Medicine, Palo Alto, CA, USA.'}]",Journal of sleep research,['10.1111/jsr.13476']
965,34543523,Ultrasound energy consumption and macular changes with manual and femtolaser-assisted high-fluidics cataract surgery: a prospective randomized comparison.,"PURPOSE


The purpose of the study was to compare ultrasound (US) consumption and central macular thickness (CMT) and volume changes with manual and femtosecond laser (FSL)-assisted cataract nucleus workup.
METHODS


Sixty patients scheduled for immediate sequential bilateral surgery underwent a prospective randomized intraindividual comparison of nucleus sector fragmentation performed manually in one eye and with low-energy FSL assistance in the partner eye, followed by high-fluidics phacoaspiration with a maximum US power of 30%. Ultrasound (US) energy consumption and macular thickness and volume were compared as measured by intraoperative effective phacoemulsification time (EPT) and high-resolution spectral domain optical coherence tomography pre- and 1 week, 3 weeks and 6 weeks postoperatively. Results are presented as means ± SD or medians [min; max].
RESULTS


Fifty-two patients completed the full follow-up. For the manual and FSL-assisted groups, nuclear hardness was almost identical with a mean LOCS III grade of 2.44 ± 1.08 and 2.50 ± 1.00 (p = 0.371). Median EPT was 1.40 [0.2; 8.3] and 1.25 [0.2; 9.4] seconds. Median preoperative CMT was 276.50 [263.25; 289.75] µm and 276.00 [262.00; 290.00] µm. Median postoperative CMT was 278.00 [260.50; 288.00] versus 275.50 [264.00; 290.50] µm at 1 week, 279.50 [266.75; 292.25] versus 280.00 [266.50; 294.50] µm at 3 weeks and 280.50 [268.00, 293.75] versus 279.50 [264.75; 295.25] µm at 6 weeks. Differences in CMT and total macular volume between the groups were not statistically significant at any point in time.
CONCLUSION


Femtosecond laser (FSL) prefragmentation of the nucleus into six sectors did not reduce US energy consumption compared with manual splitting of the nucleus into four quadrants in this particular surgical setting. Sectorial FSL-prechopping with the low-energy FSL used had no additional impact on postoperative macular thickness and volume.",2022,Sectorial FSL-prechopping with the low-energy FSL used had no additional impact on postoperative macular thickness and volume.,['Sixty patients scheduled for immediate sequential bilateral surgery'],"['ultrasound (US) consumption and central macular thickness (CMT', 'Femtosecond laser (FSL', 'manual and femtosecond laser (FSL)-assisted cataract', 'Ultrasound energy consumption and macular changes with manual and femtolaser-assisted high-fluidics cataract surgery', 'nucleus sector fragmentation performed manually in one eye and with low-energy FSL assistance']","['postoperative macular thickness and volume', 'nuclear hardness', 'CMT and total macular volume', 'Median postoperative CMT']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",60.0,0.0273004,Sectorial FSL-prechopping with the low-energy FSL used had no additional impact on postoperative macular thickness and volume.,"[{'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Röggla', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Gregor S', 'Initials': 'GS', 'LastName': 'Reiter', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}]",Acta ophthalmologica,['10.1111/aos.14983']
966,34549852,Effectiveness of an internet-based intervention to improve sleep difficulties in a culturally diverse sample of international students: A randomised controlled pilot study.,"Sleep difficulties are widespread among international students. Internet-based interventions are suggested as a low-threshold treatment option but may require cultural adaptation among culturally diverse populations. The present pilot study investigated the effectiveness and acceptance of an internet-based intervention to improve sleep difficulties in international students. A total of 81 international students of 36 nationalities were randomly assigned to the intervention (n = 41) or waitlist control group (n = 40). The intervention group received immediate access to a culturally non-adapted unguided internet-based sleep intervention consisting of three modules based on sleep hygiene and cognitive techniques to reduce rumination. At baseline, 4 and 12 weeks after randomisation, insomnia severity, measured by the Insomnia Severity Index, and secondary outcomes (sleep quality, depression, anxiety, perceived stress, well-being, presenteeism, mental health literacy) were assessed. Data were analysed using linear multi-level analyses. Additionally, satisfaction and perceived cultural appropriateness of the intervention were evaluated by international students after 4 weeks, and compared with ratings of German students, who represent the original target group. Insomnia severity improved over time in the intervention group compared to the control group, revealing a significant estimated mean difference of -5.60 (Hedges' g = 0.84, p < 0.001) after 12 weeks. Satisfaction and perceived cultural appropriateness was high and comparable to that of German students. The present study shows that a culturally non-adapted internet-based sleep intervention can be a low-threshold treatment option to help meet the high demand for mental healthcare among international students. It thus indicates that cultural adaptation might not represent a precondition for providing effective internet-based sleep interventions to this target group.",2022,The intervention group received immediate access to a culturally non-adapted unguided internet-based sleep intervention consisting of three modules based on sleep hygiene and cognitive techniques to reduce rumination.,"['international students', 'culturally diverse sample of international students', '81 international students of 36 nationalities']","['waitlist control group', 'immediate access to a culturally non-adapted unguided internet-based sleep intervention consisting of three modules based on sleep hygiene and cognitive techniques to reduce rumination', 'culturally non-adapted internet-based sleep intervention', 'internet-based intervention']","['Insomnia severity', 'sleep difficulties', 'Sleep difficulties', 'Satisfaction and perceived cultural appropriateness', 'satisfaction and perceived cultural appropriateness', 'insomnia severity, measured by the Insomnia Severity Index, and secondary outcomes (sleep quality, depression, anxiety, perceived stress, well-being, presenteeism, mental health literacy']","[{'cui': 'C3472518', 'cui_str': 'International student'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0027473', 'cui_str': 'Nationality'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]",81.0,0.0234453,The intervention group received immediate access to a culturally non-adapted unguided internet-based sleep intervention consisting of three modules based on sleep hygiene and cognitive techniques to reduce rumination.,"[{'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Spanhel', 'Affiliation': 'Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Burdach', 'Affiliation': 'Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Lehr', 'Affiliation': 'Department of Health Psychology, Institute of Psychology, Leuphana University Lueneburg, Lueneburg, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Spiegelhalder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Psychology und Digital Mental Health Care, Department of Sport and Health Sciences, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Bengel', 'Affiliation': 'Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Lasse B', 'Initials': 'LB', 'LastName': 'Sander', 'Affiliation': 'Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Freiburg, Germany.'}]",Journal of sleep research,['10.1111/jsr.13493']
967,34559420,Specialist breast care nurses for support of women with breast cancer.,"BACKGROUND


Interventions by specialist breast cancer nurses (SBCNs) aim to support women and help them cope with the impact of the disease on their quality of life.
OBJECTIVES


To assess the effects of individual interventions carried out by SBCNs on indicators of quality of life, anxiety, depression, and participant satisfaction.
SEARCH METHODS


In June 2020, we searched MEDLINE, Embase, CENTRAL (Trials only), Cochrane Breast Cancer Group's Specialist Register (CBCG SR), CINAHL, PsycINFO, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and Clinicaltrials.gov.
SELECTION CRITERIA


We selected randomised controlled trials (RCTs) of interventions carried out by SBCNs for women with breast cancer, which reported indicators of quality of life, anxiety, depression, and participant satisfaction.
DATA COLLECTION AND ANALYSIS


The certainty of the evidence was evaluated using the GRADE approach. A narrative description of the results including structured tabulation was carried out.
MAIN RESULTS


We included 14 RCTs involving 2905 women. With the exception of one study (women with advanced breast cancer), all the women were diagnosed with primary breast cancer. Mean age ranged from 48 to 64 years. Psychosocial nursing interventions compared with standard care for women with primary breast cancer Eight studies (1328 women, low-quality evidence) showed small improvements in general health-related quality of life or no difference in effect between nine weeks and 18 months. Six studies (897 women, low-quality evidence) showed small improvements in cancer-specific quality of life or no difference in effect between nine weeks and 18 months. Six studies (951 women, low-quality evidence) showed small improvements in anxiety and depression between nine weeks and 18 months. Two studies (320 women, low-quality evidence) measured satisfaction during survivorship; one study measured satisfaction only in the intervention group and showed high levels of satisfaction with care; the second study showed equal satisfaction with care in both groups at six months. Psychosocial nursing interventions compared with other supportive care interventions for women with primary breast cancer Two studies (351 women, very-low quality evidence) measured general health-related quality of life. One study reported that psychological morbidity reduced over the 12-month period; scores were consistently lower in women supported by SBCNs alone compared to support from a voluntary organisation. The other study reported that at six months, women receiving psychosocial support by either SBCNs or psychologists clinically improved from ""higher levels of distress"" to ""lower levels of distress"". One study (179 women, very-low quality evidence) showed no between-group differences on subscales at all time points up to six months measured using cancer-specific quality of life questionnaires. There were significant group-by-time changes in the global quality of life, nausea and vomiting, and systemic therapy side effects subscales, for women receiving psychosocial support by either SBCNs or psychologists at six months. There were improvements in other subscales over time in both groups. Systemic therapy side effects increased significantly in the psychologist group but not in the SBCN group. Sexual functioning decreased in both groups. Two studies (351 women, very-low quality evidence) measured anxiety and depression. One study reported that anxiety subscale scores and state anxiety scores improved over six months but there was no effect on depression subscale scores in the SBCN group compared to the psychologist group. There was no group-by-time interaction on the anxiety and depression or state anxiety subscales. The other study reported that anxiety and depression scores reduced over the 12-month post-surgery period in the SBCN group; scores were consistently lower in women supported by SBCNs compared to support from a voluntary organisation. SBCN-led telephone interventions delivering follow-up care compared with usual care for women with primary breast cancer Three studies (931 women, moderate-quality evidence) reported general health-related quality of life outcomes. Two studies reported no difference in psychological morbidity scores between SBCN-led follow-up care and standard care at 18 to 24 months. One trial reported no change in feelings of control scores between SBCN-led follow-up care and standard care at 12 months. Two studies (557 women, moderate-quality evidence) reported no between-group difference in cancer-specific quality of life at 18 to 24 months. A SBCN intervention conducted by telephone, as a point-of-need access to specialist care, did not change psychological morbidity compared to routine clinical review at 18 months. Scores for both groups on the breast cancer subscale improved over time, with lower scores at nine and 18 months compared to baseline. The adjusted mean differences between groups at 18 months was 0.7 points in favour of the SBCN intervention (P = 0.058). A second study showed no differences between groups for role and emotional functioning measured using cancer-specific quality of life questionnaires in a SBCN-led telephone intervention compared with standard hospital care, both with and without an educational group programme at 12 months. At 12 months, mean scores were 78.4 (SD = 16.2) and 77.7 (SD = 16.2) respectively for SBCN-led telephone and standard hospital follow-up. The 95% confidence interval difference at 12 months was -1.93 to 4.64. Three studies (1094 women, moderate-quality evidence) reported no between-group difference in anxiety between 12 and 60 months follow-up. One of these studies also measured depression and reported no difference in depression scores between groups at five years (anxiety: RR 1.8; 95% CI 0.6 to 5.1; depression: RR 1.7 95% CI 0.4 to 7.2). Four studies (1331 women, moderate-quality evidence) demonstrated high levels of satisfaction with SBCN-led follow-up care by telephone between 12 and 60 months. Psychosocial nursing interventions compared with usual care for women with advanced breast cancer One study (105 women, low-quality evidence) showed no difference in cancer-specific quality of life outcomes at 3 months.
AUTHORS' CONCLUSIONS


Evidence suggests that psychosocial interventions delivered by SBCNs for women with primary breast cancer may improve or are at least as effective as standard care and other supportive interventions, during diagnosis, treatment and survivorship. SBCN-led telephone follow-up interventions were equally as effective as standard care, for women with primary breast cancer.",2021,"SBCN-led telephone follow-up interventions were equally as effective as standard care, for women with primary breast cancer.","['14 RCTs involving 2905 women', 'women with advanced breast cancer', 'women with primary breast cancer Two studies (351 women, very-low quality evidence', 'women with primary breast cancer', 'specialist breast cancer nurses (SBCNs', 'Mean age ranged from 48 to 64 years', 'women with primary breast cancer Eight studies (1328 women, low-quality evidence', 'women with breast cancer', 'women with advanced breast cancer One study (105 women, low-quality evidence']","['supportive care interventions', 'SBCN-led telephone interventions delivering follow-up care compared with usual care', 'Psychosocial nursing interventions', 'SBCN-led telephone intervention']","['psychological morbidity', 'depression subscale scores', 'Sexual functioning', 'breast cancer subscale', 'anxiety and depression scores', 'quality of life, anxiety, depression, and participant satisfaction', 'general health-related quality of life', 'anxiety and depression or state anxiety subscales', 'mean scores', 'anxiety', 'cancer-specific quality of life questionnaires', 'depression scores', 'cancer-specific quality of life outcomes', 'anxiety and depression', 'global quality of life, nausea and vomiting, and systemic therapy side effects subscales', 'cancer-specific quality of life', 'psychological morbidity scores', 'feelings of control scores', 'anxiety subscale scores and state anxiety scores', 'Systemic therapy side effects']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3899107', 'cui_str': 'Follow-Up Care'}, {'cui': 'C3853031', 'cui_str': 'Psychosocial Nursing'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",2905.0,0.177068,"SBCN-led telephone follow-up interventions were equally as effective as standard care, for women with primary breast cancer.","[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Brown', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Cruickshank', 'Affiliation': 'Applied Health Research, The Royal Marsden, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Noblet', 'Affiliation': 'Breast Unit, Queen Alexandra Hospital, Cosham, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD005634.pub3']
968,34543687,"Kidney Disease, Hypertension Treatment, and Cerebral Perfusion and Structure.","RATIONALE & OBJECTIVE


The safety of intensive blood pressure (BP) targets is controversial for persons with chronic kidney disease (CKD). We studied the effects of hypertension treatment on cerebral perfusion and structure in individuals with and without CKD.
STUDY DESIGN


Neuroimaging substudy of a randomized trial.
SETTING & PARTICIPANTS


A subset of participants in the Systolic Blood Pressure Intervention Trial (SPRINT) who underwent brain magnetic resonance imaging studies. Presence of baseline CKD was assessed by estimated glomerular filtration rate (eGFR) and urinary albumin-creatinine ratio (UACR).
INTERVENTION


Participants were randomly assigned to intensive (systolic BP <120 mm Hg) versus standard (systolic BP <140 mm Hg) BP lowering.
OUTCOMES


The magnetic resonance imaging outcome measures were the 4-year change in global cerebral blood flow (CBF), white matter lesion (WML) volume, and total brain volume (TBV).
RESULTS


A total of 716 randomized participants with a mean age of 68 years were enrolled; follow-up imaging occurred after a median 3.9 years. Among participants with eGFR <60 mL/min/1.73 m 2  (n = 234), the effects of intensive versus standard BP treatment on change in global CBF, WMLs, and TBV were 3.38 (95% CI, 0.32 to 6.44) mL/100 g/min, -0.06 (95% CI, -0.16 to 0.04) cm 3  (inverse hyperbolic sine-transformed), and -3.8 (95% CI, -8.3 to 0.7) cm 3 , respectively. Among participants with UACR >30 mg/g (n = 151), the effects of intensive versus standard BP treatment on change in global CBF, WMLs, and TBV were 1.91 (95% CI, -3.01 to 6.82) mL/100 g/min, 0.003 (95% CI, -0.13 to 0.13) cm 3  (inverse hyperbolic sine-transformed), and -7.0 (95% CI, -13.3 to -0.3) cm 3 , respectively. The overall treatment effects on CBF and TBV were not modified by baseline eGFR or UACR; however, the effect on WMLs was attenuated in participants with albuminuria (P = 0.04 for interaction).
LIMITATIONS


Measurement variability due to multisite design.
CONCLUSIONS


Among adults with hypertension who have primarily early kidney disease, intensive versus standard BP treatment did not appear to have a detrimental effect on brain perfusion or structure. The findings support the safety of intensive BP treatment targets on brain health in persons with early kidney disease.
FUNDING


SPRINT was funded by the National Institutes of Health (including the National Heart, Lung, and Blood Institute; the National Institute of Diabetes and Digestive and Kidney Diseases; the National Institute on Aging; and the National Institute of Neurological Disorders and Stroke), and this substudy was funded by the National Institutes of Diabetes and Digestive and Kidney Diseases.
TRIAL REGISTRATION


SPRINT was registered at ClinicalTrials.gov with study number NCT01206062.",2021,"The overall treatment effects on cerebral blood flow and total brain volume were not modified by baseline eGFR or UACR; however the effect on WMLs was attenuated in participants with albuminuria (interaction p-value 0.04).
","['A subset of participants in the Systolic Blood Pressure Intervention Trial who underwent brain MRI studies', 'persons with chronic kidney disease (CKD', 'hypertensive adults with primarily early kidney disease', '716 randomized participants with mean age of 68 years', 'persons with early kidney disease']","['hypertension treatment', 'intensive blood pressure treatment targets', 'intensive blood pressure (BP']","['glomerular filtration rate (eGFR) and urine albumin to creatinine ratio (UACR', 'global cerebral blood flow, white matter lesion (WML) volume, and total brain volume', 'cerebral blood flow and total brain volume', 'global cerebral blood flow, WMLs and total brain volume', 'BP lowering', 'WMLs', 'cerebral perfusion and structure']","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4028269', 'cui_str': 'Nuclear magnetic resonance imaging brain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C2752009', 'cui_str': 'White matter lesion'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",716.0,0.137978,"The overall treatment effects on cerebral blood flow and total brain volume were not modified by baseline eGFR or UACR; however the effect on WMLs was attenuated in participants with albuminuria (interaction p-value 0.04).
","[{'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Kurella Tamura', 'Affiliation': 'Geriatric Research and Education Clinical Center, Palo Alto VA Health Care System, Palo Alto, CA; Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA. Electronic address: mktamura@stanford.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gaussoin', 'Affiliation': 'Departments of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Departments of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Zaharchuk', 'Affiliation': 'Department of Radiology, Stanford University School of Medicine, Palo Alto, CA.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Department of Internal Medicine, Section on Nephrology, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Psychiatry & Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Auchus', 'Affiliation': 'Department of Neurology, University of Mississippi Medical Center, Jackson, MS.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Department of Medicine, Division of Nephrology and Hypertension, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Division of Cardiovascular Disease, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kendrick', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, Denver, CO.'}, {'ForeName': 'Christianne L', 'Initials': 'CL', 'LastName': 'Roumie', 'Affiliation': 'VA Tennessee Valley Healthcare System Geriatrics Research and Education Clinical Center and Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Division of Nephrology & Hypertension, Department of Internal Medicine, University of Utah and Veterans Affairs Salt Lake City Healthcare System, Salt Lake City, UT.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology & Hypertension, Department of Internal Medicine, University of Utah and Veterans Affairs Salt Lake City Healthcare System, Salt Lake City, UT.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': ""Sticht Center for Healthy Aging and Alzheimer's Prevention, Wake Forest School of Medicine, Winston-Salem, NC.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Detre', 'Affiliation': 'Departments of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Sudipto', 'Initials': 'S', 'LastName': 'Dolui', 'Affiliation': 'Radiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'R Nick', 'Initials': 'RN', 'LastName': 'Bryan', 'Affiliation': 'Department of Diagnostic Medicine Dell Medical School, University of Texas Austin Austin, TX.'}, {'ForeName': 'Ilya M', 'Initials': 'IM', 'LastName': 'Nasrallah', 'Affiliation': 'Radiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2021.07.024']
969,34543068,One-Year Committed Exercise Training Reverses Abnormal Left Ventricular Myocardial Stiffness in Patients With Stage B Heart Failure With Preserved Ejection Fraction.,"BACKGROUND


Individuals with left ventricular (LV) hypertrophy and elevated cardiac biomarkers in middle age are at increased risk for the development of heart failure with preserved ejection fraction. Prolonged exercise training reverses the LV stiffening associated with healthy but sedentary aging; however, whether it can also normalize LV myocardial stiffness in patients at high risk for heart failure with preserved ejection fraction is unknown. In a prospective, randomized controlled trial, we hypothesized that 1-year prolonged exercise training would reduce LV myocardial stiffness in patients with LV hypertrophy.
METHODS


Forty-six patients with LV hypertrophy (LV septum >11 mm) and elevated cardiac biomarkers (N-terminal pro-B-type natriuretic peptide [>40 pg/mL] or high-sensitivity troponin T [>0.6 pg/mL]) were randomly assigned to either 1 year of high-intensity exercise training (n=30) or attention control (n=16). Right-heart catheterization and 3-dimensional echocardiography were performed while preload was manipulated using both lower body negative pressure and rapid saline infusion to define the LV end-diastolic pressure-volume relationship. A constant representing LV myocardial stiffness was calculated from the following: P=S×[Exp {a (V-V 0 )}-1], where ""P"" is transmural pressure (pulmonary capillary wedge pressure - right atrial pressure), ""S"" is the pressure asymptote of the curve, ""V"" is the LV end-diastolic volume index, ""V 0 "" is equilibrium volume, and ""a"" is the constant that characterizes LV myocardial stiffness.
RESULTS


Thirty-one participants (exercise group [n=20]: 54±6 years, 65% male; and controls (n=11): 51±6 years, 55% male) completed the study. One year of exercise training increased max by 21% (baseline 26.0±5.3 to 1 year later 31.3±5.8 mL·min -1 ·kg -1 ,  P <0.0001, interaction  P =0.0004), whereas there was no significant change in max in controls (baseline 24.6±3.4 to 1 year later 24.2±4.1 mL·min -1 ·kg -1 ,  P =0.986). LV myocardial stiffness was reduced (right and downward shift in the end-diastolic pressure-volume relationship; LV myocardial stiffness: baseline 0.062±0.020 to 1 year later 0.031±0.009), whereas there was no significant change in controls (baseline 0.061±0.033 to 1 year later 0.066±0.031, interaction  P =0.001).
CONCLUSIONS


In patients with LV hypertrophy and elevated cardiac biomarkers (stage B heart failure with preserved ejection fraction), 1 year of exercise training reduced LV myocardial stiffness. Thus, exercise training may provide protection against the future risk of heart failure with preserved ejection fraction in such patients. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03476785.",2021,"LV myocardial stiffness was reduced (right and downward shift in the end-diastolic pressure-volume relationship; LV myocardial stiffness: baseline 0.062±0.020 to 1 year later 0.031±0.009), whereas there was no significant change in controls (baseline 0.061±0.033 to 1 year later 0.066±0.031, interaction  P =0.001).
","['Thirty-one participants (exercise group [n=20]: 54±6 years, 65% male; and controls (n=11): 51±6 years, 55% male) completed the study', 'patients with LV hypertrophy', 'Patients With Stage B Heart Failure With Preserved Ejection Fraction', 'patients with LV hypertrophy and elevated cardiac biomarkers (stage B heart failure with preserved ejection fraction', 'Forty-six patients with LV hypertrophy (LV septum >11 mm) and elevated cardiac biomarkers (N-terminal pro-B-type natriuretic peptide [>40 pg/mL] or high-sensitivity troponin T [>0.6 pg/mL']","['exercise training', 'high-intensity exercise training (n=30) or attention control', 'Prolonged exercise training', 'Right-heart catheterization and 3-dimensional echocardiography', 'Exercise Training Reverses']","['LV myocardial stiffness', 'Abnormal Left Ventricular Myocardial Stiffness']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149721', 'cui_str': 'Left ventricular hypertrophy'}, {'cui': 'C0441781', 'cui_str': 'Stage B'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0225870', 'cui_str': 'Interventricular septum structure'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C4068883', 'cui_str': '0.6'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}]",46.0,0.0307601,"LV myocardial stiffness was reduced (right and downward shift in the end-diastolic pressure-volume relationship; LV myocardial stiffness: baseline 0.062±0.020 to 1 year later 0.031±0.009), whereas there was no significant change in controls (baseline 0.061±0.033 to 1 year later 0.066±0.031, interaction  P =0.001).
","[{'ForeName': 'Michinari', 'Initials': 'M', 'LastName': 'Hieda', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas (M.H., S.S., C.M.H., J.P.M., K.A.D., M.S., D.P., S.L., M.M., B.D.L.).'}, {'ForeName': 'Satyam', 'Initials': 'S', 'LastName': 'Sarma', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas (M.H., S.S., C.M.H., J.P.M., K.A.D., M.S., D.P., S.L., M.M., B.D.L.).'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Hearon', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas (M.H., S.S., C.M.H., J.P.M., K.A.D., M.S., D.P., S.L., M.M., B.D.L.).'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'MacNamara', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas (M.H., S.S., C.M.H., J.P.M., K.A.D., M.S., D.P., S.L., M.M., B.D.L.).'}, {'ForeName': 'Katrin A', 'Initials': 'KA', 'LastName': 'Dias', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas (M.H., S.S., C.M.H., J.P.M., K.A.D., M.S., D.P., S.L., M.M., B.D.L.).'}, {'ForeName': 'Mitchel', 'Initials': 'M', 'LastName': 'Samels', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas (M.H., S.S., C.M.H., J.P.M., K.A.D., M.S., D.P., S.L., M.M., B.D.L.).'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Palmer', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas (M.H., S.S., C.M.H., J.P.M., K.A.D., M.S., D.P., S.L., M.M., B.D.L.).'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Livingston', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas (M.H., S.S., C.M.H., J.P.M., K.A.D., M.S., D.P., S.L., M.M., B.D.L.).'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Morris', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas (M.H., S.S., C.M.H., J.P.M., K.A.D., M.S., D.P., S.L., M.M., B.D.L.).'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Levine', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas (M.H., S.S., C.M.H., J.P.M., K.A.D., M.S., D.P., S.L., M.M., B.D.L.).'}]",Circulation,['10.1161/CIRCULATIONAHA.121.054117']
970,34550563,Intraoperative use of low-dose dexmedetomidine for the prevention of emergence agitation following general anaesthesia in elderly patients: a randomized controlled trial.,"OBJECTIVE


To clarify the effect of an intraoperative low-dose dexmedetomidine infusion on emergence agitation following general anaesthesia in elderly patients.
METHODS


Eighty elderly patients (> 64-years-old) following elective general anaesthesia for radical cancer surgeries were randomly allocated into two groups (n = 40 each): the dexmedetomidine group (Group D) and the normal saline group (Group C). Anaesthesia was maintained with continuous intravenous infusion of dexmedetomidine at - 0.2 µg kg -1  h -1  in Group D, and an equal volume of normal saline (0.5 ml kg -1  h -1 ) was given in Group C. All patients were observed for 30 min in the post-anaesthesia care unit (PACU), AFPS and NRS were recorded every 2 min, and the total doses of nalbuphine and fentanyl were calculated in the PACU. MAP and HR were recorded at the time of 10 min (T1), 20 min (T2), 30 min (T3) after dexmedetomidine or saline pumping, and before extubation (T4), immediately after extubation (T5), and 5 min after extubation (T6). We also documented some durations, including anaesthesia duration (D1), surgery duration (D2), duration from the end of surgery to extubation (D3), and emergence agitation duration (D4).
RESULTS


The MAP in Group C was significantly higher than that in Group D (P < 0.05), and there were no significant changes between the two groups in HR and MAP within each time point and D1, D2, D3, and D4. The incidence of agitation, NRS score and total dose of nalbuphine and fentanyl were all lower in Group D than in Group C (P < 0.05).
CONCLUSION


An intraoperative low-dose dexmedetomidine continuous infusion can reduce emergence agitation following general anaesthesia in elderly patients (> 64-years-old), remain stable in terms of haemodynamics, and not lead to delays in anaesthesia recovery time and extubation time.",2022,"The incidence of agitation, NRS score and total dose of nalbuphine and fentanyl were all lower in Group D than in Group C (P < 0.05).
","['Eighty elderly patients (>\u200964-years-old) following elective general anaesthesia for radical cancer surgeries', 'elderly patients (>\u200964-years-old', 'elderly patients']","['normal saline (0.5\xa0ml\xa0kg', 'dexmedetomidine continuous infusion', 'intraoperative low-dose dexmedetomidine infusion', 'dexmedetomidine', 'normal saline']","['incidence of agitation, NRS score and total dose of nalbuphine and fentanyl', 'anaesthesia duration (D1), surgery duration (D2), duration from the end of surgery to extubation (D3), and emergence agitation duration (D4', 'emergence agitation', 'HR and MAP within each time point and D1, D2, D3, and D4', 'MAP and HR']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",80.0,0.0892341,"The incidence of agitation, NRS score and total dose of nalbuphine and fentanyl were all lower in Group D than in Group C (P < 0.05).
","[{'ForeName': 'Meiyan', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Weifang Medical University, Weifang, 261000, China.'}, {'ForeName': 'Tianliang', 'Initials': 'T', 'LastName': 'Peng', 'Affiliation': 'School of Anesthesiology, Weifang Medical University, Weifang, 261000, China.'}, {'ForeName': 'Yingui', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Weifang Medical University, Weifang, 261000, China.'}, {'ForeName': 'Zhaolu', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Weifang Medical University, Weifang, 261000, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Chunling', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'School of Anesthesiology, Weifang Medical University, Weifang, 261000, China.'}, {'ForeName': 'Yanjing', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Anesthesiology, Weifang Medical University, Weifang, 261000, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'School of Anesthesiology, Weifang Medical University, Weifang, 261000, China.'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Kong', 'Affiliation': 'School of Anesthesiology, Weifang Medical University, Weifang, 261000, China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'School of Anesthesiology, Weifang Medical University, Weifang, 261000, China.'}, {'ForeName': 'Xude', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, Tang Du Hospital, Air Force Medical University, Xi'an, 710038, China. sunxude@fmmu.edu.cn.""}, {'ForeName': 'Xiaoyong', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Weifang Medical University, Weifang, 261000, China. zhaoxiaoyong@wfmc.edu.cn.'}]",Aging clinical and experimental research,['10.1007/s40520-021-01984-y']
971,34561695,Absence of drug-drug interactions between γ-hydroxybutyric acid (GHB) and cobicistat.,"OBJECTIVES


Potential interactions between CYP3A4 inhibitors and γ-hydroxybutyric acid (GHB) have been suggested as a possible explanation for cases of GHB overdose in recent years among people living with HIV engaged in chemsex. Our objective was to assess the effect of cobicistat on the pharmacokinetics of GHB.
METHODS


Fifteen healthy adults were enrolled in this randomized, double-blind, placebo-controlled, two-arm, crossover clinical trial. Participants underwent two 5 day treatment periods with at least a 1 week washout period between them. In each treatment period, participants received cobicistat (150 mg q24h orally) or matched placebo. On day 5 of each treatment period, participants were given a single oral dose of GHB (25 mg/kg). Plasma concentrations of GHB, subjective effects, blood pressure, heart rate and oxygen saturation were monitored for 5 h after dosing. GHB pharmacokinetic and pharmacodynamic parameters were calculated for each participant during each study period by non-compartmental analysis and were compared using linear mixed-effects models. The study was registered at https://www.clinicaltrialsregister.eu (Eudra-CT number 2019-002122-71) and at https://clinicaltrials.gov (NCT04322214).
RESULTS


Ten participants completed the two study periods. No drug-related adverse events that necessitated subject withdrawal or medical intervention occurred during the study. Compared with placebo, none of the primary pharmacokinetic parameters of GHB was substantially changed by the administration of GHB with cobicistat. Similarly, no differences regarding subjective or physiological effects were observed when GHB was administered alone or with cobicistat.
CONCLUSIONS


Neither pharmacokinetic nor pharmacodynamic drug-drug interactions between cobicistat and GHB were identified in this study.",2021,"Compared with placebo, none of the primary pharmacokinetic parameters of GHB was substantially changed by the administration of GHB with cobicistat.","['people living with HIV engaged in chemsex', 'Fifteen healthy adults']","['γ-hydroxybutyric acid (GHB) and cobicistat', 'CYP3A4 inhibitors and γ-hydroxybutyric acid (GHB', 'GHB', 'cobicistat (150\u2009mg q24h orally) or matched placebo', 'placebo']","['Plasma concentrations of GHB, subjective effects, blood pressure, heart rate and oxygen saturation', 'GHB pharmacokinetic and pharmacodynamic parameters', 'subjective or physiological effects', 'GHB']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0673093', 'cui_str': '4-hydroxybutyric acid'}, {'cui': 'C3177235', 'cui_str': 'cobicistat'}, {'cui': 'C3850053', 'cui_str': 'CYP3A4 Inhibitors'}, {'cui': 'C0000503', 'cui_str': '4-hydroxybutyrate'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1275548', 'cui_str': 'Every twenty four hours'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0000503', 'cui_str': '4-hydroxybutyrate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",15.0,0.209522,"Compared with placebo, none of the primary pharmacokinetic parameters of GHB was substantially changed by the administration of GHB with cobicistat.","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Moltó', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Bailón', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Pérez-Mañá', 'Affiliation': 'Department of Clinical Pharmacology, Hospital Universitari Germans Trias i Pujol and Institut de Recerca Germans Trias i Pujol (HUGTiP-IGTP), Badalona, Spain.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Papaseit', 'Affiliation': 'Department of Clinical Pharmacology, Hospital Universitari Germans Trias i Pujol and Institut de Recerca Germans Trias i Pujol (HUGTiP-IGTP), Badalona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Miranda', 'Affiliation': 'Fundació Lluita contra la Sida, Badalona, Spain.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Martín', 'Affiliation': 'Department of Clinical Pharmacology, Hospital Universitari Germans Trias i Pujol and Institut de Recerca Germans Trias i Pujol (HUGTiP-IGTP), Badalona, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Mothe', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Magí', 'Initials': 'M', 'LastName': 'Farré', 'Affiliation': 'Department of Clinical Pharmacology, Hospital Universitari Germans Trias i Pujol and Institut de Recerca Germans Trias i Pujol (HUGTiP-IGTP), Badalona, Spain.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkab359']
972,34558835,Ipragliflozin Improves the Hepatic Outcomes of Patients With Diabetes with NAFLD.,"Sodium glucose cotransporter-2 inhibitors (SGLT2is) are now widely used to treat diabetes, but their effects on nonalcoholic fatty liver disease (NAFLD) remain to be determined. We aimed to evaluate the effects of SGLT2is on the pathogenesis of NAFLD. A multicenter, randomized, controlled trial was conducted in patients with type 2 diabetes with NAFLD. The changes in glycemic control, obesity, and liver pathology were compared between participants taking ipragliflozin (50 mg/day for 72 weeks; IPR group) and participants being managed without SGLT2is, pioglitazone, glucagon-like peptide-1 analogs, or insulin (CTR group). In the IPR group (n = 25), there were significant decreases in hemoglobin A1c (HbA1c) and body mass index (BMI) during the study (HbA1c, -0.41%, P < 0.01; BMI, -1.06 kg/m 2  , P < 0.01), whereas these did not change in the CTR group (n = 26). Liver pathology was evaluated in 21/25 participants in the IPR/CTR groups, and hepatic fibrosis was found in 17 (81%) and 18 (72%) participants in the IPR and CTR groups at baseline. This was ameliorated in 70.6% (12 of 17) of participants in the IPR group and 22.2 % (4 of 18) of those in the CTR group (P < 0.01). Nonalcoholic steatohepatitis (NASH) resolved in 66.7% of IPR-treated participants and 27.3% of CTR participants. None of the participants in the IPR group developed NASH, whereas 33.3% of the CTR group developed NASH. Conclusion: Long-term ipragliflozin treatment ameliorates hepatic fibrosis in patients with NAFLD. Thus, ipragliflozin might be effective for the treatment and prevention of NASH in patients with diabetes, as well as improving glycemic control and obesity. Therefore, SGLT2is may represent a therapeutic choice for patients with diabetes with NAFLD, but further larger studies are required to confirm these effects.",2022,"None of the participants in the IPR group developed NASH, whereas 33.3% of the CTR group developed NASH.","['Patients With Diabetes with NAFLD', 'patients with type 2 diabetes with NAFLD', 'patients with NAFLD', 'patients with diabetes', 'patients with diabetes with NAFLD']","['SGLT2is, pioglitazone, glucagon-like peptide-1 analogs, or insulin (CTR group', 'SGLT2is', 'ipragliflozin', 'Ipragliflozin', 'Sodium glucose cotransporter-2 inhibitors (SGLT2is']","['Nonalcoholic steatohepatitis (NASH', 'NASH', 'glycemic control, obesity, and liver pathology', 'hepatic fibrosis', 'Liver pathology', 'hemoglobin A1c (HbA1c) and body mass index (BMI', 'Hepatic Outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0859988,"None of the participants in the IPR group developed NASH, whereas 33.3% of the CTR group developed NASH.","[{'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Division of Metabolism and Endocrinology, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Takaomi', 'Initials': 'T', 'LastName': 'Kessoku', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Miwa', 'Initials': 'M', 'LastName': 'Kawanaka', 'Affiliation': 'Department of General Internal Medicine Kawasaki Medical Center, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Nonaka', 'Affiliation': 'Department of Gastroenterology and Hepatology, JA Hiroshima General Hospital, Hatsukaichi, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Hyogo', 'Affiliation': 'Department of Gastroenterology and Hepatology, JA Hiroshima General Hospital, Hatsukaichi, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Department of Gastroenterology and Hepatology, Osaka City Juso Hospital, Osaka, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Department of Hepatology, Sapporo Kosei General Hospital, Sapporo, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Imajo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Division of Metabolism and Endocrinology, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Kubotsu', 'Affiliation': 'Division of Metabolism and Endocrinology, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Isoda', 'Affiliation': 'Liver Center, Saga University Hospital, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Oeda', 'Affiliation': 'Liver Center, Saga University Hospital, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Kurai', 'Affiliation': 'Department of Gastroenterology and Hepatology, Osaka City Juso Hospital, Osaka, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Yoneda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': ""Internal Medicine, Tokyo Women's Medical University Medical Center East, Tokyo, Japan.""}, {'ForeName': 'Yoichiro', 'Initials': 'Y', 'LastName': 'Kitajima', 'Affiliation': 'Division of Metabolism and Endocrinology, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Tajiri', 'Affiliation': 'Clinical Research Center, Saga University Hospital, Saga, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Takamori', 'Affiliation': 'Clinical Research Center, Saga University Hospital, Saga, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kawaguchi', 'Affiliation': 'Education and Research Center for Community Medicine, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Aishima', 'Affiliation': 'Department of Pathology and Microbiology, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Kage', 'Affiliation': 'Kurume University Research Center for Innovative Cancer Therapy, Kurume, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Eguchi', 'Affiliation': 'Liver Center, Saga University Hospital, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Keizo', 'Initials': 'K', 'LastName': 'Anzai', 'Affiliation': 'Division of Metabolism and Endocrinology, Faculty of Medicine, Saga University, Saga, Japan.'}]",Hepatology communications,['10.1002/hep4.1696']
973,34562067,"Evaluation of the safety, tolerability, and pharmacokinetics of RO7049389 in healthy Chinese volunteers.","The objectives of this phase I study are to assess the safety, tolerability, and pharmacokinetics (PKs) of RO7049389 in healthy Chinese volunteers (HVs) and evaluate potential ethnic differences in the safety and PKs using data from this study and the first-in-human study (in which most of the HVs were non-Asian). HVs randomly received a single dose of 200-600 mg of RO7049389 or a placebo in a single ascending dose (n = 28) or multiple doses of 200-400 mg of RO7049389 or a placebo in multiple ascending doses (n = 24). Safety and tolerability were monitored throughout the study. Serial blood samples were collected for PK analysis. RO7049389 was safe and well-tolerated in the HVs. The time to maximum concentration ranged from 1.5 to 3.0 h, and terminal half-life ranged from 3.66 to 14.6 h. A single dose of 200-600 mg and multiple doses of 200-400 mg exhibited nonlinear PKs. In general, the safety profiles were comparable between non-Asian and Asian HVs, but the plasma exposure of RO7049389 in Chinese HVs was higher than that in non-Asian HVs. The data generated from this study will provide guidance for future clinical studies on RO7049389 in Chinese/Asian patients with hepatitis B virus.",2022,"In general, the safety profiles were comparable between non-Asian and Asian HVs, but the plasma exposure of RO7049389 in Chinese HVs was higher than that in non-Asian HVs.","['healthy Chinese volunteers (HVs', 'Chinese/Asian patients with hepatitis B virus', 'healthy Chinese volunteers']","['placebo', 'multiple doses of 200-400\xa0mg of RO7049389 or a placebo', '200-600\xa0mg and multiple doses of 200-400\xa0mg exhibited nonlinear PKs']","['time to maximum concentration', 'Safety and tolerability', 'safety, tolerability, and pharmacokinetics (PKs', 'safe and well-tolerated', 'safety, tolerability, and pharmacokinetics']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0739823,"In general, the safety profiles were comparable between non-Asian and Asian HVs, but the plasma exposure of RO7049389 in Chinese HVs was higher than that in non-Asian HVs.","[{'ForeName': 'Xiaojie', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Phase I Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Pharmaceutical Sciences, Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Wenhong', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Pharmaceutical Sciences, Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Mingfen', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'I2O DTA, Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Triyatni', 'Affiliation': 'Early Development Safety, Roche Pharma, Basel, Switzerland.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Biostatistics, Roche Pharma Product Development Shanghai, Shanghai, China.'}, {'ForeName': 'Qingyan', 'Initials': 'Q', 'LastName': 'Bo', 'Affiliation': 'I2O DTA, Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Yuyan', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Pharmaceutical Sciences, Roche Innovation Center Shanghai, Shanghai, China.'}]",Clinical and translational science,['10.1111/cts.13134']
974,34558214,Perioperative amino acid infusion reestablishes muscle net balance during total hip arthroplasty.,"Surgery and anesthesia induce a catabolic response that leads to skeletal muscle protein loss. Previous investigations have observed positive effects of perioperative nutrition. Furthermore, the benefits of exogenous amino acids on muscle protein kinetics are well established. However, no investigation has focused on muscle protein kinetics with and without perioperative amino acid infusion. Thus, we aimed to assess the effect of perioperative amino acid (AA) infusion on muscle protein balance in individuals undergoing elective total hip arthroplasty (THA). Elective THA patients were randomized to undergo a metabolic study prior to surgery (n = 5; control [CON]), intraoperative AA infusion (n = 9), or no AA (n = 13; standard of care [SC]). The CON group was studied prior to surgery to provide nonoperative/non-anesthesia muscle protein kinetic reference values. The bolus infusion method with  13  C 6  -phenylalanine injected at time 0, and [ 15  N]-phenylalanine 30 min later was used to calculate muscle protein synthesis (MPS), protein breakdown (MPB), and net balance (MPS-MPB). Perioperative AA significantly improved muscle net balance as compared to SC (-0.005 ± 0.018%/h vs. -0.052 ± 0.011%/h) but not CON (0.003 ± 0.013%/h). The AA infusion significantly increased muscle net balance via a significant increase in MPS (AA = 0.062 ± 0.007%/h; SC = 0.037 ± 0.004%/h; CON = 0.072% ± 0.005%/h), and a nonsignificant attenuation of MPB (AA = 0.067 ± 0.012%/h; SC = 0.089 ± 0.014%/h; CON = 0.075 ± 0.011%/h). Our data support the use of perioperative AA infusion during elective THA as pragmatic strategy to offset the loss of surgically induced skeletal muscle protein.",2021,Perioperative AA significantly improved muscle net balance as compared to SC (-0.005 ± 0.018%/h vs. -0.052 ± 0.011%/h) but not CON (0.003 ± 0.013%/h).,"['individuals undergoing elective total hip arthroplasty (THA', 'Elective THA patients', 'total hip arthroplasty']","['exogenous amino acids', 'metabolic study prior to surgery (n\xa0=\xa05; control [CON]), intraoperative AA infusion (n\xa0=\xa09), or no AA', 'perioperative amino acid (AA) infusion', 'CON', 'Perioperative amino acid infusion']","['MPS', 'muscle net balance', 'muscle protein synthesis (MPS), protein breakdown (MPB), and net balance (MPS-MPB']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0412467', 'cui_str': 'Radionuclide metabolic studies'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0699900', 'cui_str': 'Catabolism'}, {'cui': 'C4083212', 'cui_str': 'Male pattern alopecia'}]",,0.0677239,Perioperative AA significantly improved muscle net balance as compared to SC (-0.005 ± 0.018%/h vs. -0.052 ± 0.011%/h) but not CON (0.003 ± 0.013%/h).,"[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Church', 'Affiliation': 'Department of Geriatrics, Center for Translational Research in Aging & Longevity, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Schutzler', 'Affiliation': 'Department of Geriatrics, Center for Translational Research in Aging & Longevity, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Wolfe', 'Affiliation': 'Department of Geriatrics, Center for Translational Research in Aging & Longevity, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.'}, {'ForeName': 'Arny A', 'Initials': 'AA', 'LastName': 'Ferrando', 'Affiliation': 'Department of Geriatrics, Center for Translational Research in Aging & Longevity, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.'}]",Physiological reports,['10.14814/phy2.15055']
975,34562058,The micro-shear bond strength of resin cements to aged laser bleached enamel after using different desensitizing agents.,"OBJECTIVES


To evaluate the micro-shear bond strength of two resin cements to aged laser bleached enamel after the application of three different desensitizing agents.
MATERIALS AND METHODS


Forty extracted human central and lateral incisors were prepared and bleached using laser activation bleaching protocol. The teeth were assigned randomly into four groups for desensitization; G1: No post-bleaching treatment, G2: GC MI Paste Plus, G3: Hydroxyapatite nanoparticles (n-HAP) and G4: Flor-Opal. Specimens were subjected to aging for 6 months. All groups were subdivided into two subgroups according to the resin cements used (dual-curing resin cement and light-curing resin cement).
RESULTS


Flor-Opal groups showed the highest statistically significant micro-shear bond strength (MSBS), followed by GC MI Paste Plus and n-HAP groups with no statistically significant difference between them. The light-curing resin cement had statistically higher MSBS than dual-curing resin cement in case of no-post bleaching treatment and n-HAP groups, and no statistical difference in case of GC MI Paste Plus and Flor-Opal groups.
CONCLUSION


Usage of desensitizing agents containing, CPP-ACP, n-HAP or fluoride after laser bleaching can enhance the bond strength of the resin cements to enamel.
CLINICAL SIGNIFICANCE


The composition of the desensitizing agents applied after laser bleaching could interfere in bond strength values.",2022,"The light-curing resin cement had statistically higher MSBS than dual-curing resin cement in case of no-post bleaching treatment and n-HAP groups, and no statistical difference in case of GC MI Paste","['Forty extracted human central and lateral incisors', 'All groups were subdivided into two subgroups according to the resin cements used (dual-curing resin cement and light-curing resin cement']","['GC MI Paste', 'G3: Hydroxyapatite nanoparticles (n-HAP) and G4: Flor-Opal', 'laser activation bleaching protocol', 'desensitization; G1: No post-bleaching treatment, G2: GC MI Paste']","['bond strength', 'MSBS', 'micro-shear bond strength (MSBS', 'bond strength values']","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0376523', 'cui_str': 'Resin Cement'}, {'cui': 'C0382301', 'cui_str': 'DCR cement'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0084990', 'cui_str': 'VPDA protocol'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0178702', 'cui_str': 'Desensitization therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",40.0,0.0376191,"The light-curing resin cement had statistically higher MSBS than dual-curing resin cement in case of no-post bleaching treatment and n-HAP groups, and no statistical difference in case of GC MI Paste","[{'ForeName': 'Aya E', 'Initials': 'AE', 'LastName': 'Samaha', 'Affiliation': 'Faculty of Dentistry, Ain Shams university, Cairo, Egypt.'}, {'ForeName': 'Ahmad K', 'Initials': 'AK', 'LastName': 'ElFadl', 'Affiliation': 'Faculty of Dentistry, Ain Shams university, Cairo, Egypt.'}, {'ForeName': 'Mohammed N', 'Initials': 'MN', 'LastName': 'Anwar', 'Affiliation': 'Faculty of Dentistry, Ain Shams university, Cairo, Egypt.'}]",Clinical and experimental dental research,['10.1002/cre2.496']
976,34561972,HBcrAg Levels Are Associated With Virological Response to Treatment With Interferon in Patients With Hepatitis Delta.,"Standard treatment of hepatitis delta virus (HDV) infection remains pegylated-interferon alfa (peg-IFNα) in most centers, which is not only associated with rather low efficacy but several adverse events. Hepatitis B core-related antigen (HBcrAg) is linked to intrahepatic covalently closed circular DNA levels and has previously been suggested as response predictor in IFN-based treatment of hepatitis B virus (HBV) mono-infection. This study aimed to investigate the value of HBcrAg in the management of patients with HBV/HDV co-infection undergoing peg-IFNα treatment. The Hep-Net-International-Delta-Hepatitis-Intervention Trial-2 study included 120 patients co-infected with HBV/HDV. Patients were treated for 96 weeks with peg-IFNα and either tenofovir or placebo. Ninety-nine patients with HDV-RNA results 24 weeks after end of treatment (FU24) were included in this analysis, of whom 32 patients (32.3%) had undetectable HDV RNA at FU24. HBcrAg was measured at baseline, week 12, 24, 48, 96, and FU24. HBcrAg levels showed no significant correlation with HDV RNA but were significantly linked to treatment outcome. HBcrAg levels < 4.5 log IU/mL at baseline, week 24, and week 48 had high negative predictive value (NPV) for achieving undetectable HDV RNA at FU24 (81.8%, 87.1% and 95.0%, respectively). Similarly, HBcrAg levels at week 96 were significantly higher in patients with viral relapse until FU24 (3.0 vs. 3.63 log IU/mL; P = 0.0089). Baseline, week 24, and week 48 HBcrAg levels were also associated with the likelihood of achieving HBsAg level < 100 IU/mL at FU24 (HBcrAg < 3.0 log IU/mL: NPV 91.7%, 90.4% and 92.3%, respectively). Test statistics improved when combining HBcrAg with additional viral and clinical parameters. Conclusion: HBcrAg is linked to treatment response to peg-IFNα in patients with HBV/HDV co-infection and could be a promising marker to determine treatment futility.",2022,"HBcrAg levels < 4.5 log IU/mL at baseline, week 24, and week 48 had high negative predictive value (NPV) for achieving undetectable HDV RNA at FU24 (81.8%, 87.1% and 95.0%, respectively).","['patients with HBV/HDV co-infection undergoing peg-IFNα treatment', 'Patients With Hepatitis Delta', '120 patients co-infected with HBV/HDV', 'patients with HBV/HDV co-infection']","['tenofovir or placebo', 'Interferon', 'hepatitis delta virus (HDV) infection remains pegylated-interferon alfa (peg-IFNα']","['HDV RNA', 'likelihood of achieving HBsAg level', 'HBcrAg levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0011220', 'cui_str': 'Hepatitis D virus'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011226', 'cui_str': 'Viral hepatitis D'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0011220', 'cui_str': 'Hepatitis D virus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}]","[{'cui': 'C0011220', 'cui_str': 'Hepatitis D virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0430420', 'cui_str': 'Antigen assay'}]",120.0,0.0659741,"HBcrAg levels < 4.5 log IU/mL at baseline, week 24, and week 48 had high negative predictive value (NPV) for achieving undetectable HDV RNA at FU24 (81.8%, 87.1% and 95.0%, respectively).","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sandmann', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Yurdaydin', 'Affiliation': 'Department of Gastroenterology, University of Ankara Medical School, Ankara, Turkey.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Deterding', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Heidrich', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Svenja', 'Initials': 'S', 'LastName': 'Hardtke', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lehmann', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Bremer', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Manns', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Cornberg', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Heiner', 'Initials': 'H', 'LastName': 'Wedemeyer', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Maasoumy', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hepatology communications,['10.1002/hep4.1821']
977,34561741,"Invited Commentary: Prostatic Artery Embolization Versus Transurethral Resection of the Prostate: A Post Hoc Cost Analysis of a Randomized Controlled Clinical Trial, By Capdevila et al.",,2021,,[],['Prostatic Artery Embolization Versus Transurethral Resection of the Prostate'],[],[],"[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0397760', 'cui_str': 'Embolization of artery'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]",[],,0.161371,,"[{'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Ray', 'Affiliation': 'Department of Radiology, University of Illinois College of Medicine, 1740 W. Taylor St, Chicago, IL, 60614, USA. chray@uic.edu.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-021-02972-5']
978,34554369,Longitudinal effects of cigarette pictorial warning labels among young adults.,"Young adults are influenced by cigarette package marketing. Pictorial warning labels are a recommended intervention. Evidence demonstrates pictorial warnings impact negative emotion, risk perceptions, and motivation to quit smoking, but there is limited research on their effects over time. This study analyzes data from a randomized trial of young adult smokers (N = 229) exposed to a pictorial or text-only cigarette warning. We assessed changes in fear, anger, risk perceptions, and motivation to quit smoking after 4 weeks using latent change score modeling and over 3 months using latent growth modeling. Latent change results showed exposure was associated with increases in fear, anger, and motivation to quit after 4 weeks. Latent growth showed exposure was associated with increases in motivation to quit smoking over 3 months, but not other outcomes. Findings suggest pictorial warning labels produce an emotional response and increase motivation to quit among young adult smokers.",2022,"We assessed changes in fear, anger, risk perceptions, and motivation to quit smoking after 4 weeks using latent change score modeling and over 3 months using latent growth modeling.","['young adult smokers', 'Young adults', 'young adults', 'young adult smokers (N\u2009=\u2009229']","['cigarette pictorial warning labels', 'pictorial or text-only cigarette warning']","['fear, anger, and motivation to quit', 'fear, anger, risk perceptions, and motivation to quit smoking', 'motivation to quit smoking', 'emotional response and increase motivation to quit']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0520939', 'cui_str': 'Increased motivation'}]",,0.068786,"We assessed changes in fear, anger, risk perceptions, and motivation to quit smoking after 4 weeks using latent change score modeling and over 3 months using latent growth modeling.","[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychiatry and Tobacco Center of Regulatory Science, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, Philadelphia, PA, 19104-3309, USA. andrea.johnson1@pennmedicine.upenn.edu.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Simmens', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Monique M', 'Initials': 'MM', 'LastName': 'Turner', 'Affiliation': 'Department of Communication, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'W Douglas', 'Initials': 'WD', 'LastName': 'Evans', 'Affiliation': 'Prevention and Community Health Department, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Strasser', 'Affiliation': 'Department of Psychiatry and Tobacco Center of Regulatory Science, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, Philadelphia, PA, 19104-3309, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': 'Department of Internal Medicine, Wexner Medical Center, Center for Tobacco Research, The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-021-00258-2']
979,34560015,"Efficacy and safety of PXL770, a direct AMP kinase activator, for the treatment of non-alcoholic fatty liver disease (STAMP-NAFLD): a randomised, double-blind, placebo-controlled, phase 2a study.","BACKGROUND


AMP kinase (AMPK) is an energy sensor implicated in regulation of lipid metabolism, inflammation, and insulin sensitivity. We aimed to assess efficacy and safety of PXL770, a novel direct AMPK activator, in patients with non-alcoholic fatty liver disease (NAFLD).
METHODS


STAMP-NAFLD, a randomised, double-blind, placebo-controlled phase 2a study, was done across 15 US clinical sites. Patients aged 18-75 years with liver fat content of at least 10% at baseline when assessed by MRI-proton density fat fraction (MRI-PDFF) were eligible. Patients were randomly assigned (1:1:1:1), via an interactive web response system, to receive oral PXL770 250 mg once daily, 250 mg twice daily, or 500 mg once daily, or matched placebo. Patients were stratified according to type 2 diabetes status and study site. The primary endpoint was relative change in liver fat content from baseline compared with placebo at week 12, assessed by MRI-PDFF. The primary endpoint was analysed in an ANCOVA model with treatment and stratification criteria as factors and baseline liver fat content as a covariate in the modified intention-to-treat population, defined as all as-randomised patients who received at least one dose of study treatment. Safety was analysed in the safety population, defined as all as-treated patients receiving at least one dose of the study treatment. The trial has been completed and the final results are reported. The trial is registered with ClinicalTrials.gov, NCT03763877.
FINDINGS


Between March 29, 2019, and March 13, 2020, 387 patients were screened, of whom 120 were included in the modified intention-to-treat and safety analyses (30 in the 250 mg once daily group, 30 in the 250 mg twice daily group, 29 in the 500 mg once daily group, and 31 in the placebo group). The mean relative change from baseline in liver fat content at week 12 was -1·1% in the placebo group, -1·0% in the 250 mg once daily group (mean difference versus placebo 0·1% [95% CI -15·4 to 15·7], p=0·99), -14·3% in the 250 mg twice daily group (-13·1% [-28·1 to 1·8], p=0·084), and -14·7% in the 500 mg once daily group (-13·5% [-28·5 to 1·4], p=0·076). At least one treatment-emergent adverse event occurred in 23 (77%) of 30 patients in the 250 mg once daily group, 20 (67%) of 30 patients in the 250 mg twice daily group, 21 (72%) of 29 patients in the 500 mg once daily group, and 21 (68%) of 31 patients in the placebo group. The most common treatment-emergent adverse event was diarrhoea (five [17%] of patients in the 250 mg once daily group, seven [23%] in the 250 mg twice daily group, six [21%] in the 500 mg once daily group, and none in the placebo group). No life-threatening events or treatment-related deaths occurred.
INTERPRETATION


PXL770 treatment did not meet the primary outcome of liver fat improvement compared with placebo. Treatment was well tolerated. Given indications that metabolic features improved with PXL770 treatment, AMPK activation might be a promising pharmacological target for patients with type 2 diabetes and NAFLD, and could also be considered for further assessment in patients with non-alcoholic steatohepatitis.
FUNDING


Poxel.",2021,"No life-threatening events or treatment-related deaths occurred.
","['Patients aged 18-75 years with liver fat content of at least 10% at baseline when assessed by MRI-proton density fat fraction (MRI-PDFF) were eligible', '387 patients were screened, of whom 120 were included in the modified intention-to-treat', 'Between March 29, 2019, and March 13, 2020', 'patients with non-alcoholic steatohepatitis', 'non-alcoholic fatty liver disease (STAMP-NAFLD', 'patients with non-alcoholic fatty liver disease (NAFLD']","['placebo', 'oral PXL770', 'PXL770']","['diarrhoea', 'Safety', 'tolerated', 'liver fat improvement', 'relative change in liver fat content']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",387.0,0.446021,"No life-threatening events or treatment-related deaths occurred.
","[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Cusi', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, FL, USA; Malcom Randall Veterans Administration Medical Center, Gainesville, FL, USA.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Arizona Liver Health, Tucson, AZ, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Pinnacle Clinical Research, San Antonio, TX, USA.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Fouqueray', 'Affiliation': 'Poxel, Lyon, France.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Moller', 'Affiliation': 'Poxel, Lyon, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hallakou-Bozec', 'Affiliation': 'Poxel, Lyon, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Bolze', 'Affiliation': 'Poxel, Lyon, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Grouin', 'Affiliation': 'Department of Statistics, Université de Rouen, Rouen, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Jeannin Megnien', 'Affiliation': 'Summit Clinical Research, San Antonio, TX, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dubourg', 'Affiliation': 'Poxel, Lyon, France. Electronic address: julie.dubourg@me.com.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Ratziu', 'Affiliation': 'Institute for Cardiometabolism and Nutrition, Sorbonne Université, Hôpital Pitié Salpêtrière, Paris, France.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(21)00300-9']
980,34564686,A randomized clinical trial of topical dexamethasone vs. cyclosporine treatment for oral lichen planus.,"BACKGROUND


Oral lichen planus (OLP) is a common, frequently symptomatic, immune-mediated disease. Various treatments have been used for symptomatic OLP, including corticosteroids and immunosuppressants administered topically or systemically. The aim of this study was to compare the effectiveness of topical dexamethasone vs. topical cyclosporine in treatment of symptomatic OLP.
MATERIAL AND METHODS


Thirty-two patients with biopsy-proven symptomatic OLP were randomly assigned to two therapeutic groups: dexamethasone 2mg/5ml or cyclosporine 100mg/ml, both administered topically in a swish and spit method three times a day for 4 weeks. The patients were followed up for a total of 6 months. Assessed parameters included clinical scoring (according to Thongprasom's scale, 0-5), pain (VAS scale, 0-10), dysphagia and speech difficulties (none, mild or severe). Possible side effects, including fungal overgrowth, were also recorded.
RESULTS


At the end of the 4-week treatment period, both dexamethasone and cyclosporine showed a statistically significant improvement in clinical scoring (p<0.025 and p=0.034, respectively), which was better with dexamethasone (p=0.001). In addition, both dexamethasone and cyclosporine induced statistical significant improvement in pain and dysphagia (and speech difficulties for dexamethasone), without significant differences between the two groups. Regarding side effects, patients in the dexamethasone group developed candidiasis more frequently compared to cyclosporine (p=0.031). At the end of the 6-month follow-up period, the difference in response between the two groups was not statistically significant. Interestingly, a trend for further improvement compared with the end of the 4-week treatment period was noticed only for patients treated with cyclosporine.
CONCLUSIONS


Despite the small number of enrolled patients, topical cyclosporine treatment induces a significant clinical improvement in symptomatic OLP patients, which, compared to topical dexamethasone, appears to be less pronounced during initial administration, but capable to induce further improvement after discontinuation with a satisfactory long-term remission in the absence of significant side effects. This study may contribute to a better understanding of the differences in effectiveness of OLP topical treatments and guide future larger scale clinical trials.",2022,"In addition, both dexamethasone and cyclosporine induced statistical significant improvement in pain and dysphagia (and speech difficulties for dexamethasone), without significant differences between the two groups.","['oral lichen planus', 'Thirty-two patients with biopsy-proven symptomatic OLP']","['dexamethasone and cyclosporine', 'dexamethasone', 'cyclosporine', 'dexamethasone 2mg/5ml or cyclosporine', 'topical dexamethasone vs. cyclosporine', 'topical dexamethasone vs. topical cyclosporine']","['pain and dysphagia (and speech difficulties for dexamethasone', ""clinical scoring (according to Thongprasom's scale, 0-5), pain (VAS scale, 0-10), dysphagia and speech difficulties (none, mild or severe"", 'candidiasis', 'clinical scoring']","[{'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0233715', 'cui_str': 'Disturbance in speech'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006840', 'cui_str': 'Candidiasis'}]",32.0,0.0529868,"In addition, both dexamethasone and cyclosporine induced statistical significant improvement in pain and dysphagia (and speech difficulties for dexamethasone), without significant differences between the two groups.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Georgaki', 'Affiliation': 'Department of Oral Medicine and Pathology and Hospital Dentistry School of Dentistry, National and Kapodistrian University of Athens 2 Thivon St., Goudi 11527, Athens, Greece mar1georgaki@gmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Piperi', 'Affiliation': ''}, {'ForeName': 'V-I', 'Initials': 'VI', 'LastName': 'Theofilou', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pettas', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stoufi', 'Affiliation': ''}, {'ForeName': 'N-G', 'Initials': 'NG', 'LastName': 'Nikitakis', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.25040']
981,34558200,"First-in-human study of milvexian, an oral, direct, small molecule factor XIa inhibitor.","Milvexian (BMS-986177/JNJ-70033093) is a small molecule, active-site inhibitor of factor XIa (FXIa) being developed to prevent and treat thrombotic events. The safety, tolerability, pharmacokinetics (PKs), and pharmacodynamics (PDs) of milvexian were assessed in a two-part, double-blind, placebo-controlled, sequential single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy adults. Participants in SAD panels (6 panels of 8 participants; n = 48) were randomized (3:1) to receive milvexian (4, 20, 60, 200, 300, or 500 mg) or placebo. The 200- and 500-mg panels investigated the pharmacokinetic impact of a high-fat meal. Participants in MAD panels (7 panels of 8 participants; n = 56) were randomized (3:1) to receive milvexian (once- or twice-daily) or placebo for 14 days. All milvexian dosing regimens were safe and well-tolerated, with only mild treatment-emergent adverse events and no clinically significant bleeding events. In SAD panels, maximum milvexian plasma concentration occurred 3 h postdose in all fasted panels. The terminal half-life (T 1/2  ) ranged from 8.3 to 13.8 h. In fasted panels from 20 to 200 mg, absorption was dose-proportional; results at higher doses (300 and 500 mg) were consistent with saturable absorption. Food increased milvexian bioavailability in a dose-dependent fashion. In MAD panels, steady-state milvexian plasma concentration was reached within 3 and 6 dosing days with once- and twice-daily dosing, respectively. Renal excretion was less than 20% in all panels. Prolongation of activated partial thromboplastin time was observed and was directly related to drug exposure. These results suggest that the safety, tolerability, PK, and PD properties of milvexian are suitable for further clinical development.",2022,"All milvexian dosing regimens were safe and well-tolerated, with only mild treatment-emergent adverse events and no clinically significant bleeding events.","['Participants in MAD panels (7 panels of 8 participants; n\xa0=\xa056', 'healthy adults', 'Participants in SAD panels (6 panels of 8 participants; n\xa0=\xa048']","['milvexian', 'placebo', 'milvexian (once- or twice-daily) or placebo', 'Milvexian (BMS-986177/JNJ-70033093']","['steady-state milvexian plasma concentration', 'milvexian bioavailability', 'safety, tolerability, PK, and PD properties of milvexian', 'Renal excretion', 'safety, tolerability, pharmacokinetics (PKs), and pharmacodynamics (PDs) of milvexian', 'Prolongation of activated partial thromboplastin time', 'safe and well-tolerated', 'bleeding events', 'maximum milvexian plasma concentration']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3853087', 'cui_str': 'One to two times'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C1373187', 'cui_str': 'Renal Excretion'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",48.0,0.164483,"All milvexian dosing regimens were safe and well-tolerated, with only mild treatment-emergent adverse events and no clinically significant bleeding events.","[{'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Perera', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Zhaoqing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Luettgen', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Danshi', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'DeSouza', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cerra', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Seiffert', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}]",Clinical and translational science,['10.1111/cts.13148']
982,34562260,Correction to: Quality of life in a randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel in patients with metastatic breast cancer.,,2022,,['patients with metastatic breast cancer'],['3-week cycle nab-paclitaxel'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]",[],,0.0505218,,"[{'ForeName': 'Naruto', 'Initials': 'N', 'LastName': 'Taira', 'Affiliation': 'Department of Breast and Endocrine Surgery, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan. ntaira@md.okayama-u.ac.jp.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kashiwabara', 'Affiliation': 'Clinical Research Promotion Center, University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tsurutani', 'Affiliation': 'Advanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kitada', 'Affiliation': 'Breast Disease Center, Asahikawa Medical University Hospital, Hokkaido, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Hokkaido, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kato', 'Affiliation': 'Department of Breast Surgery, Teine Keijinkai Hospital, Hokkaido, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kikawa', 'Affiliation': 'Department of Breast Surgery, Kansai Medical University Hospital, Osaka, Japan.'}, {'ForeName': 'Eiko', 'Initials': 'E', 'LastName': 'Sakata', 'Affiliation': 'Department of Breast Surgery, Niigata City General Hospital, Niigata, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Naito', 'Affiliation': 'Department of Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Yoshie', 'Initials': 'Y', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Breast Surgery, Hirosaki Municipal Hospital, Aomori, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Department of Breast Surgery, Japanese Red Cross Saitama Hospital, Saitama, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Iwasa', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takashima', 'Affiliation': 'Department of Breast and Endocrine Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Aihara', 'Affiliation': 'Breast Center, Aihara Hospital, Osaka, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'Department of Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Fumikata', 'Initials': 'F', 'LastName': 'Hara', 'Affiliation': 'Breast Oncology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}]","Breast cancer (Tokyo, Japan)",['10.1007/s12282-021-01296-z']
983,34563635,Parotid Gland Stem Cell Sparing Radiation Therapy for Patients With Head and Neck Cancer: A Double-Blind Randomized Controlled Trial.,"PURPOSE


Radiation therapy for head and neck cancer frequently leads to salivary gland damage and subsequent xerostomia. The radiation response of the parotid glands of rats, mice, and patients critically depends on dose to parotid gland stem cells, mainly located in the gland's main ducts (stem cell rich [SCR] region). Therefore, this double-blind randomized controlled trial aimed to test the hypothesis that parotid gland stem cell sparing radiation therapy preserves parotid gland function better than currently used whole parotid gland sparing radiation therapy.
METHODS AND MATERIALS


Patients with head and neck cancer (n = 102) treated with definitive radiation therapy were randomized between standard parotid-sparing and stem cell sparing (SCS) techniques. The primary endpoint was >75% reduction in parotid gland saliva production compared with pretreatment production (FLOW 12M ). Secondary endpoints were several aspects of xerostomia 12 months after treatment.
RESULTS


Fifty-four patients were assigned to the standard arm and 48 to the SCS arm. Only dose to the SCR regions (contralateral 16 and 11 Gy [P = .004] and ipsilateral 26 and 16 Gy [P = .001] in the standard and SCS arm, respectively) and pretreatment patient-rated daytime xerostomia (35% and 13% [P = .01] in the standard and SCS arm, respectively) differed significantly between the arms. In the SCS arm, 1 patient (2.8%) experienced FLOW 12M  compared with 2 (4.9%) in the standard arm (P = 1.00). However, a trend toward better relative parotid gland salivary function in favor of SCS radiation therapy was shown. Moreover, multivariable analysis showed that mean contralateral SCR region dose was the strongest dosimetric predictor for moderate-to-severe patient-rated daytime xerostomia and grade ≥2 physician-rated xerostomia, the latter including reported alteration in diet.
CONCLUSIONS


No significantly better parotid function was observed in SCS radiation therapy. However, additional multivariable analysis showed that dose to the SCR region was more predictive of the development of parotid gland function-related xerostomia endpoints than dose to the entire parotid gland.",2022,"Only dose to the SCR regions (contralateral 16 and 11 Gy (p=0.004) and ipsilateral 26 and 16 Gy (p=0.001), standard and SCS arm respectively) and pretreatment patient-rated daytime xerostomia (35% and 13% (p=0.01), standard and SCS arm respectively) differed significantly between the arms.","['Fifty-four patients were assigned to the standard arm and 48 to the SCS arm', 'head and neck cancer (HNC', 'head and neck cancer patients', 'HNC patients (n=102) treated with']","['Parotid gland stem cell sparing radiotherapy', 'parotid gland stem cell sparing radiotherapy', 'SCS radiotherapy', 'standard parotid sparing and stem cell sparing (SCS) techniques', 'definitive radiotherapy']","['daytime xerostomia and grade ≥2 physician-rated xerostomia', 'relative parotid gland salivary function', 'parotid function', 'FLOW 12M', 'parotid gland saliva production', 'pretreatment patient-rated daytime xerostomia', 'several aspects of xerostomia 12 months after treatment']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0030580', 'cui_str': 'Parotid gland structure'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0030580', 'cui_str': 'Parotid gland structure'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1272569', 'cui_str': 'Parotid gland saliva'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]",54.0,0.278668,"Only dose to the SCR regions (contralateral 16 and 11 Gy (p=0.004) and ipsilateral 26 and 16 Gy (p=0.001), standard and SCS arm respectively) and pretreatment patient-rated daytime xerostomia (35% and 13% (p=0.01), standard and SCS arm respectively) differed significantly between the arms.","[{'ForeName': 'Roel J H M', 'Initials': 'RJHM', 'LastName': 'Steenbakkers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. Electronic address: r.steenbakkers@umcg.nl.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'van Rijn-Dekker', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Monique A', 'Initials': 'MA', 'LastName': 'Stokman', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Roel G J', 'Initials': 'RGJ', 'LastName': 'Kierkels', 'Affiliation': 'Department of Radiation Oncology, Radiotherapiegroep, Deventer, The Netherlands.'}, {'ForeName': 'Arjen', 'Initials': 'A', 'LastName': 'van der Schaaf', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Johanna G M', 'Initials': 'JGM', 'LastName': 'van den Hoek', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Hendrik P', 'Initials': 'HP', 'LastName': 'Bijl', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Maria C A', 'Initials': 'MCA', 'LastName': 'Kramer', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Coppes', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands; Department of Biomedical Sciences of Cell and Systems, Section Molecular Cell Biology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Johannes A', 'Initials': 'JA', 'LastName': 'Langendijk', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van Luijk', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. Electronic address: p.van.luijk@umcg.nl.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.09.023']
984,34563627,Acupuncture for Quality of Life in Gastric Cancer Patients Undergoing Adjuvant Chemotherapy.,"CONTEXT


Patients with gastric cancer experience health-related quality of life (HRQOL) decline during adjuvant chemotherapy following gastrectomy.
OBJECTIVES


This pilot study aimed to evaluate the preliminary effect and feasibility of electro-acupuncture (EA) for HRQOL and symptom burden in these patients.
METHODS


In this open-label, multicenter, parallel controlled trial, gastric cancer patients who planned to receive adjuvant chemotherapy were randomly assigned to receive high-dose EA (seven times each chemotherapy cycle for three cycles), low-dose EA (three times each chemotherapy cycle), or usual care only. The acupoints prescription consisted of bilateral ST36, PC6, SP4, and DU20, EX-HN3, and selected Back-shu points. Patients completed the Functional Assessment of Cancer Therapy-Gastric (FACT-Ga) weekly, and the Edmonton Symptom Assessment System (ESAS). The primary outcome was the difference among the groups on the gastric cancer subscale (GaCS) of the FACT-Ga.
RESULTS


Of the 66 randomized patients, 58 were analyzed according to intention-to-treat principle, and 45 were in the per-protocol set (PPS). The average scores in PPS of GaCS were 52.12±9.71, 51.85±12.36, and 45.37±8.61 in high-dose EA, low-dose EA, and control groups, respectively. EA was significantly associated with improved average GaCS scores when compared with control group (51.98±10.91 vs. 45.37±8.61, P = 0.039). EA treatment also produced ESAS relief at the end of intervention (14.36 ± 12.28 vs. 23.91 ± 15.52, P = 0.027). Participants in EA groups had fewer grade ≥3 leukopenia (0% vs. 15.79%, P = 0.031) and neutropenia (2.56% vs. 26.31%, P = 0.012).
CONCLUSION


EA showed promising effects in improving HRQOL, controlling symptom burden, and reducing toxicity during adjuvant chemotherapy in gastric cancer patients. Future adequately powered trials are feasible and needed to confirm the specific effect of EA.",2022,"Participants in EA groups had fewer grade ≥3 leukopenia (0% versus 15.79%, p=0.031) and neutropenia (2.56% versus 26.31%, p=0.012).
","['gastric cancer patients', 'Patients with gastric cancer experience health-related quality of life (HRQOL) decline during adjuvant chemotherapy following gastrectomy', 'patients', 'gastric cancer patients who planned to receive adjuvant chemotherapy', 'Gastric Cancer Patients Undergoing Adjuvant Chemotherapy']","['Acupuncture', 'bilateral ST36, PC6, SP4, and DU20, EX-HN3, and selected Back-shu points', 'electro-acupuncture (EA']","['Functional Assessment of Cancer Therapy-Gastric', 'neutropenia', 'HRQOL, controlling symptom burden, and reducing toxicity', 'ESAS relief', 'average GaCS scores', 'average scores in PPS of GaCS', 'gastric cancer subscale (GaCS) of the FACT-Ga', 'Quality of Life', 'grade ≥3 leukopenia']","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0450533', 'cui_str': 'ST36'}, {'cui': 'C0135624', 'cui_str': 'PC6 extract'}, {'cui': 'C0450546', 'cui_str': 'SP4'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C3472649', 'cui_str': 'Edmonton symptom assessment system'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}]",66.0,0.295059,"Participants in EA groups had fewer grade ≥3 leukopenia (0% versus 15.79%, p=0.031) and neutropenia (2.56% versus 26.31%, p=0.012).
","[{'ForeName': 'Yan-Juan', 'Initials': 'YJ', 'LastName': 'Zhu', 'Affiliation': 'Department of Oncology (Y.J.Z., X.S.C., D.D.Z., Y.D.C., H.B.Z.), Guangdong Provincial Hospital of Traditional Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China; Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome (Y.J.Z., H.B.Z.), Guangzhou, China; Guangdong-Hong Kong-Macau Joint Lab on Chinese Medicine and Immune Disease Research (Y.J.Z., H.B.Z.), Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xiao-Yu', 'Initials': 'XY', 'LastName': 'Wu', 'Affiliation': 'Gastrointestinal Surgery (X.Y.W., G.N.W.), Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Gastrointestinal Surgery, Guangdong Provincial Hospital of Traditional Chinese Medicine (W.W., D.C.D., J.W.), the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xue-Song', 'Initials': 'XS', 'LastName': 'Chang', 'Affiliation': 'Department of Oncology (Y.J.Z., X.S.C., D.D.Z., Y.D.C., H.B.Z.), Guangdong Provincial Hospital of Traditional Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Dan-Dan', 'Initials': 'DD', 'LastName': 'Zhan', 'Affiliation': 'Department of Oncology (Y.J.Z., X.S.C., D.D.Z., Y.D.C., H.B.Z.), Guangdong Provincial Hospital of Traditional Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'De-Chang', 'Initials': 'DC', 'LastName': 'Diao', 'Affiliation': 'Gastrointestinal Surgery, Guangdong Provincial Hospital of Traditional Chinese Medicine (W.W., D.C.D., J.W.), the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Medical Oncology, the Sixth Affiliated Hospital (J.X., T.Y.C., X.H.Z.), Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Gastrointestinal Surgery (Y.L.), Guangdong Provincial People's Hospital, Guangzhou, China.""}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': ""Gastrointestinal Oncology (D.M.), Guangdong Provincial People's Hospital, Guangzhou, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Gastrointestinal Surgery (M.H., C.F.K.), the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jian-Chang', 'Initials': 'JC', 'LastName': 'Li', 'Affiliation': 'Gastrointestinal Surgery (J.C.L., Z.L.H.), Cancer Center of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wan', 'Affiliation': 'Gastrointestinal Surgery, Guangdong Provincial Hospital of Traditional Chinese Medicine (W.W., D.C.D., J.W.), the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Guan-Nan', 'Initials': 'GN', 'LastName': 'Wu', 'Affiliation': 'Gastrointestinal Surgery (X.Y.W., G.N.W.), Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Chuan-Feng', 'Initials': 'CF', 'LastName': 'Ke', 'Affiliation': 'Gastrointestinal Surgery (M.H., C.F.K.), the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Kai-Yu', 'Initials': 'KY', 'LastName': 'Sun', 'Affiliation': 'Gastrointestinal Surgery (K.U.S., J.J.P.), the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhi-Liang', 'Initials': 'ZL', 'LastName': 'Huang', 'Affiliation': 'Gastrointestinal Surgery (J.C.L., Z.L.H.), Cancer Center of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Tai-Yuan', 'Initials': 'TY', 'LastName': 'Cao', 'Affiliation': 'Medical Oncology, the Sixth Affiliated Hospital (J.X., T.Y.C., X.H.Z.), Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiao-Hui', 'Initials': 'XH', 'LastName': 'Zhai', 'Affiliation': 'Medical Oncology, the Sixth Affiliated Hospital (J.X., T.Y.C., X.H.Z.), Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ya-Dong', 'Initials': 'YD', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology (Y.J.Z., X.S.C., D.D.Z., Y.D.C., H.B.Z.), Guangdong Provincial Hospital of Traditional Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Peng', 'Affiliation': 'Gastrointestinal Surgery (K.U.S., J.J.P.), the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China. Electronic address: pjianj@mail.sysu.edu.cn.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Department of Medicine (J.J.M.), Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: maoj@mskcc.org.'}, {'ForeName': 'Hai-Bo', 'Initials': 'HB', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology (Y.J.Z., X.S.C., D.D.Z., Y.D.C., H.B.Z.), Guangdong Provincial Hospital of Traditional Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China; Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome (Y.J.Z., H.B.Z.), Guangzhou, China; Guangdong-Hong Kong-Macau Joint Lab on Chinese Medicine and Immune Disease Research (Y.J.Z., H.B.Z.), Guangzhou University of Chinese Medicine, Guangzhou, China; State Key Laboratory of Dampness Syndrome of Chinese Medicine (H.B.Z.), the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou China. Electronic address: haibozh@gzucm.edu.cn.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2021.09.009']
985,34569853,Inference for the treatment effect in longitudinal cluster randomized trials when treatment effect heterogeneity is ignored.,"In cluster-randomized trials, sometimes the effect of the intervention being studied differs between clusters, commonly referred to as treatment effect heterogeneity. In the analysis of stepped wedge and cluster-randomized crossover trials, it is possible to include terms in outcome regression models to allow for such treatment effect heterogeneity yet this is not frequently considered. Outside of some simulation studies of specific cases where the outcome is binary, the impact of failing to include terms for treatment effect heterogeneity on the variance of the treatment effect estimator is unknown. We analytically examine the impact of failing to include terms for treatment effect heterogeneity on the variance of the treatment effect estimator, when outcomes are continuous. Using analysis of variance and feasible generalized least squares we provide expressions for this variance. For both the cluster-randomized crossover design and the stepped wedge design, our analytic derivations indicate that failing to include treatment effect heterogeneity results in the estimates for variance of the treatment effect that are too small, leading to inflation of type I error rates. We therefore recommend assessing the sensitivity of sample size calculations and conclusions drawn from the analysis of cluster randomized trials to the inclusion of treatment effect heterogeneity.",2021,"For both the cluster-randomized crossover design and the stepped wedge design, our analytic derivations indicate that failing to include treatment effect heterogeneity results in the estimates for variance of the treatment effect that are too small, leading to inflation of type I error rates.",[],[],[],[],[],[],,0.0723898,"For both the cluster-randomized crossover design and the stepped wedge design, our analytic derivations indicate that failing to include treatment effect heterogeneity results in the estimates for variance of the treatment effect that are too small, leading to inflation of type I error rates.","[{'ForeName': 'Rhys', 'Initials': 'R', 'LastName': 'Bowden', 'Affiliation': 'School of Public Health and Preventive Medicine, 22457Monash University, Australia.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Forbes', 'Affiliation': 'School of Public Health and Preventive Medicine, 22457Monash University, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'School of Public Health and Preventive Medicine, 22457Monash University, Australia.'}]",Statistical methods in medical research,['10.1177/09622802211041754']
986,34562610,Consolidation nivolumab and ipilimumab versus observation in limited-disease small-cell lung cancer after chemo-radiotherapy - results from the randomised phase II ETOP/IFCT 4-12 STIMULI trial.,"BACKGROUND


Concurrent chemotherapy and thoracic radiotherapy followed by prophylactic cranial irradiation (PCI) is the standard treatment in limited-disease small-cell lung cancer (LD-SCLC), with 5-year overall survival (OS) of only 25% to 33%.
PATIENTS AND METHODS


STIMULI is a 1:1 randomised phase II trial aiming to demonstrate superiority of consolidation combination immunotherapy versus observation after chemo-radiotherapy plus PCI (protocol amendment-1). Consolidation immunotherapy consisted of four cycles of nivolumab [1 mg/kg, every three weeks (Q3W)] plus ipilimumab (3 mg/kg, Q3W), followed by nivolumab monotherapy (240 mg, Q2W) for up to 12 months. Patient recruitment closed prematurely due to slow accrual and the statistical analyses plan was updated to address progression-free survival (PFS) as the only primary endpoint.
RESULTS


Of the 222 patients enrolled, 153 were randomised (78: experimental; 75: observation). Among the randomised patients, median age was 62 years, 60% males, 34%/65% current/former smokers, 31%/66% performance status (PS) 0/1. Up to 25 May 2020 (median follow-up 22.4 months), 40 PFS events were observed in the experimental arm, with median PFS 10.7 months [95% confidence interval (CI) 7.0-not estimable (NE)] versus 42 events and median 14.5 months (8.2-NE) in the observation, hazard ratio (HR) = 1.02 (0.66-1.58), two-sided P = 0.93. With updated follow-up (03 June 2021; median: 35 months), median OS was not reached in the experimental arm, while it was 32.1 months (26.1-NE) in observation, with HR = 0.95 (0.59-1.52), P = 0.82. In the experimental arm, median time-to-treatment-discontinuation was only 1.7 months. CTCAE v4 grade ≥3 adverse events were experienced by 62% of patients in the experimental and 25% in the observation arm, with 4 and 1 fatal, respectively.
CONCLUSIONS


The STIMULI trial did not meet its primary endpoint of improving PFS with nivolumab-ipilimumab consolidation after chemo-radiotherapy in LD-SCLC. A short period on active treatment related to toxicity and treatment discontinuation likely affected the efficacy results.",2022,"Grade≥3 adverse events were experienced by 62% pts in experimental and 25% in observation arm, with 4 and 1 fatal, respectively.
",['222 patients enrolled'],"['Consolidation nivolumab and ipilimumab', 'ipilimumab', 'nivolumab', 'nivolumab monotherapy', 'chemotherapy and thoracic radiotherapy followed by prophylactic cranial irradiation (PCI', 'consolidation combination immunotherapy versus observation after chemo-radiotherapy plus PCI']","['40 PFS events', 'median OS', 'median time-to-treatment-discontinuation', 'Grade≥3 adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0079172', 'cui_str': 'Cranial Irradiation'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",222.0,0.232312,"Grade≥3 adverse events were experienced by 62% pts in experimental and 25% in observation arm, with 4 and 1 fatal, respectively.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland; Lausanne University, Lausanne, Switzerland.'}, {'ForeName': 'J-L', 'Initials': 'JL', 'LastName': 'Pujol', 'Affiliation': 'Thoracic Oncology Unit, Hopital Arnaud de Villeneuve, Montpellier, France.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Dafni', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece; Frontier Science Foundation-Hellas, Athens, Greece.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dómine', 'Affiliation': 'Hospital Universitario Fundacion Jimenez Díaz (IIS-FJD), Madrid, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'Medicine, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Andrade', 'Affiliation': 'Medical Oncology, Hospital Virgen De La Salud, Toledo, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Becker', 'Affiliation': 'Department of Pulmonology, Amsterdam University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Thoracic Oncology Unit, Centre Hospitalier Universitaire Grenoble-Alpes, Grenoble, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Curioni-Fontecedro', 'Affiliation': 'Department of Medical Oncology and Hematology, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Molinier', 'Affiliation': 'Department of Respiratory Disease, Centre Hospitalier - Le Mans, Le Mans, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nackaerts', 'Affiliation': 'Department of Pulmonology, Respiratory Oncology Unit, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Insa Mollá', 'Affiliation': 'Medical Oncology, Hospital Clínico Universitario De Valencia, Valencia, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gervais', 'Affiliation': 'Medical Oncology, Centre François Baclesse, Caen, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'López Vivanco', 'Affiliation': 'Medical Oncology, Hospital Universitario Cruces, Barakaldo, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Madelaine', 'Affiliation': 'Thoracic Oncology Unit, Centre Hospitalier Universitaire Caen Normandie, Caen, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Thoracic Oncology, Centre Hospitalier Universitaire Toulouse, Toulouse, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Faehling', 'Affiliation': 'Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Griesinger', 'Affiliation': 'Pius-Hospital Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Hospital De La Santa Creu I Sant Pau, Barcelona, Spain.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'González Larriba', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Provencio Pulla', 'Affiliation': 'Hospital Puerta de Hierro, Madrid, Spain.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Vervita', 'Affiliation': 'Frontier Science Foundation-Hellas, Athens, Greece.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Roschitzki-Voser', 'Affiliation': 'Coordinating Office, European Thoracic Oncology Platform, Bern, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ruepp', 'Affiliation': 'Coordinating Office, European Thoracic Oncology Platform, Bern, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mitchell', 'Affiliation': 'Olivia Newton-John Cancer Centre, Austin Hospital (VIC), Melbourne, Australia.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Stahel', 'Affiliation': 'Coordinating Office, European Thoracic Oncology Platform, Bern, Switzerland. Electronic address: Rolf.Stahel@etop-eu.org.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Le Pechoux', 'Affiliation': 'Department of Radiation Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'De Ruysscher', 'Affiliation': 'Maastricht University Medical Center, Department of Radiation Oncology (Maastro), GROW School for Oncology, Maastricht, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.09.011']
987,34571194,A Motivational Interviewing Intervention Improves Physical Symptoms in Patients with Heart Failure: A Secondary Outcome Analysis of the Motivate-HF Randomized Controlled Trial.,"CONTEXT


Heart failure (HF) patients experience high burden of physical symptoms during their disease trajectory.
OBJECTIVE


To evaluate the effects of Motivational Interviewing (MI) on the burden of physical symptoms in HF patients.
METHODS


We performed a secondary analysis of data from the MOTIVATE-HF randomized controlled trial. A sample of 510 patients (median 74 years, 58% male) and their caregivers (median 55 years, 75.5% female) was randomly allocated to Arm 1 (MI only for patients), Arm 2 (MI for patients and caregivers), and Arm 3 (standard of care). The MI intervention consisted of one face-to-face session plus three telephone calls conducted within two months from enrollment. Symptoms' burden was assessed with the Heart Failure Somatic Perception Scale (HFSPS) with the dimensions of Chest Discomfort, Dyspnea, Early and subtle and Edema. Data were collected at baseline and at 3, 6, 9, and 12 months after enrollment.
RESULTS


At 12 months, Chest Discomfort improved in Arms 1 and 2 vs Arm 3 (Δ: -8.13, 95% CI: -14.61; -1.65). Dyspnea improved in Arms 1 and 2 vs Arm 3 both at 9 and 12 months (Δ: -7, 95% CI: -13.18; -0.82 and -6.78, 95% CI: -13.19; -0.38); HFSPS total score improved in Arm 1 and Arm 2 vs Arm 3 at 9 months (Δ: -4.55, 95% CI: -9.05; -0.05). Over 1 year, Chest Discomfort and HFSPS total score in Arm 2 improved compared to Arm 3 (β= -2.61, 95% CI: -4.21; -1.00, P = 0.0015 and β=-1.35, 95% CI: -2.50; -0.21, P = 0.02).
CONCLUSION


MI reduces the burden of physical HF symptoms, particularly when caregivers are involved in the intervention.",2022,"Dyspnea improved in Arms 1 and 2 vs Arm 3 both at 9 and 12 months (Δ: -7, 95%CI: -13.18; -0.82 and -6.78, 95%CI: -13.19; -0.38); HFSPS total score improved in Arm 1 and Arm 2 vs Arm 3 at 9 months (Δ: -4.55, 95%CI: -9.05; -0.05).","['HF patients', '510 patients (median 74 years, 58% male) and their caregivers (median 55 years, 75.5% female', 'Patients with Heart Failure']","['Motivational Interviewing (MI', 'Motivational Interviewing Intervention']","['HFSPS total score', 'Dyspnea', 'Physical Symptoms', 'burden of physical HF symptoms', 'Chest Discomfort and HFSPS total score', 'Heart Failure Somatic Perception Scale (HFSPS) with the dimensions of Chest Discomfort, Dyspnea, Early and subtle and Edema', 'Chest Discomfort', 'physical symptoms', 'burden of physical symptoms']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0235710', 'cui_str': 'Chest discomfort'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",510.0,0.184495,"Dyspnea improved in Arms 1 and 2 vs Arm 3 both at 9 and 12 months (Δ: -7, 95%CI: -13.18; -0.82 and -6.78, 95%CI: -13.19; -0.38); HFSPS total score improved in Arm 1 and Arm 2 vs Arm 3 at 9 months (Δ: -4.55, 95%CI: -9.05; -0.05).","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Caggianelli', 'Affiliation': 'Department of Biomedicine and Prevention (G.C., P.I., V.Z., G.L., R.A., E.V.), University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Iovino', 'Affiliation': 'Department of Biomedicine and Prevention (G.C., P.I., V.Z., G.L., R.A., E.V.), University of Rome Tor Vergata, Rome, Italy; School of Nursing, Midwifery and Paramedicine Faculty of Health Science (P.I., G.L.), Australian Catholic University, Melbourne, Australia. Electronic address: paolo.iovino@uniroma2.it.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Rebora', 'Affiliation': 'Bicocca Bioinformatics, Biostatistics and Bioimaging Centre - B4 School of Medicine and Surgery (P.R., G.O.), University of Milan-Bicocca, Monza, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Occhino', 'Affiliation': 'Bicocca Bioinformatics, Biostatistics and Bioimaging Centre - B4 School of Medicine and Surgery (P.R., G.O.), University of Milan-Bicocca, Monza, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Zeffiro', 'Affiliation': 'Department of Biomedicine and Prevention (G.C., P.I., V.Z., G.L., R.A., E.V.), University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Locatelli', 'Affiliation': 'Department of Biomedicine and Prevention (G.C., P.I., V.Z., G.L., R.A., E.V.), University of Rome Tor Vergata, Rome, Italy; School of Nursing, Midwifery and Paramedicine Faculty of Health Science (P.I., G.L.), Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Ausili', 'Affiliation': 'Department of Medicine and Surgery (D.A.), University of Milan-Bicocca, Monza, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Alvaro', 'Affiliation': 'Department of Biomedicine and Prevention (G.C., P.I., V.Z., G.L., R.A., E.V.), University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'School of Nursing (B.R.), University of Pennsylvania, Philadelphia, PA, USA; Mary McKillop Institute of Health Research (B.R.), Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Ercole', 'Initials': 'E', 'LastName': 'Vellone', 'Affiliation': 'Department of Biomedicine and Prevention (G.C., P.I., V.Z., G.L., R.A., E.V.), University of Rome Tor Vergata, Rome, Italy.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2021.09.006']
988,34570925,Heart Rate Variability Features as Predictors of Intermittent Theta-Burst Stimulation Response in Posttraumatic Stress Disorder.,"BACKGROUND


Posttraumatic stress disorder (PTSD) is associated with autonomic dysfunction as indicated by deficits in the sympathetic and parasympathetic nervous systems. These abnormalities are expressed as elevated heart rate and reduced heart rate variability (HRV), respectively. Intermittent theta-burst stimulation (iTBS), a form of transcranial magnetic stimulation, has demonstrated effectiveness in PTSD. Nevertheless, it remains unclear whether HRV may be an iTBS biomarker for PTSD and whether iTBS impacts autonomic activity.
MATERIALS AND METHODS


Fifty Veterans with PTSD participated in a randomized controlled trial, receiving ten daily sessions of sham-controlled iTBS (right dorsolateral prefrontal cortex, 1800 pulses/day, 80% active motor threshold, 9.5 min). With a usable dataset of (N = 47), HRV parameters were assessed as predictors of clinical response immediately after stimulation. iTBS effects on autonomic response (mean RR interval, root mean square of successive differences [RMSSD], total power [TP], and low-frequency/high-frequency [LF/HF] ratio) were evaluated using an ultra-short approach.
RESULTS


TP and RMSSD were significant predictors of acute clinical response to iTBS. Individuals with higher TP had better response to iTBS with improved symptoms on the Clinician-Administered PTSD Scale (r s   = -0.58, p = 0.004), and higher functionality on the Social and Occupational Function Scale (r s   = 0.43, p = 0.04). Similarly, higher RMSSD was associated with superior outcomes (r s   = -0.44, p = 0.04). No other significant changes in HRV metrics were observed (p ≥ 0.05).
CONCLUSIONS


Our findings indicate that autonomic activity is a potential low-cost and technically simple predictive biomarker of iTBS response in PTSD. Less autonomic dysfunction was associated with superior clinical improvements with iTBS. Future studies might consider HRV acquisition during iTBS, as well as prospective testing of these findings in patients with elevated hyperarousal.",2021,"Individuals with higher TP had better response to iTBS with improved symptoms on the Clinician-Administered PTSD Scale (r s   = -0.58, p = 0.004), and higher functionality on the Social and Occupational Function Scale (r s   = 0.43, p = 0.04).","['Posttraumatic Stress Disorder', 'Posttraumatic stress disorder (PTSD', 'Fifty Veterans with PTSD participated', 'patients with elevated hyperarousal']","['sham-controlled iTBS', 'Intermittent theta-burst stimulation (iTBS']","['autonomic response (mean RR interval, root mean square of successive differences [RMSSD], total power [TP], and low-frequency/high-frequency [LF/HF] ratio', 'autonomic dysfunction', 'elevated heart rate and reduced heart rate variability (HRV', 'Clinician-Administered PTSD Scale', 'HRV metrics', 'HRV parameters', 'Social and Occupational Function Scale']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0013363', 'cui_str': 'Dysautonomia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0291721,"Individuals with higher TP had better response to iTBS with improved symptoms on the Clinician-Administered PTSD Scale (r s   = -0.58, p = 0.004), and higher functionality on the Social and Occupational Function Scale (r s   = 0.43, p = 0.04).","[{'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Cosmo', 'Affiliation': 'Department of Psychiatry and Human Behavior, The Warren Alpert Medical School, Brown University, Providence, RI, USA.'}, {'ForeName': 'Antonia V', 'Initials': 'AV', 'LastName': 'Seligowski', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Aiken', 'Affiliation': 'VA RR&D Center for Neurorestoration and Neurotechnology, VA Providence Healthcare System, Providence, RI, USA.'}, {'ForeName': 'Mascha', 'Initials': 'M', 'LastName': ""Van't Wout-Frank"", 'Affiliation': 'Department of Psychiatry and Human Behavior, The Warren Alpert Medical School, Brown University, Providence, RI, USA.'}, {'ForeName': 'Noah S', 'Initials': 'NS', 'LastName': 'Philip', 'Affiliation': 'Department of Psychiatry and Human Behavior, The Warren Alpert Medical School, Brown University, Providence, RI, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13529']
989,33430608,Microrandomized Trial Design for Evaluating Just-in-Time Adaptive Interventions Through Mobile Health Technologies for Cardiovascular Disease.,"Smartphone and wearable device use is rising broadly and can be leveraged for chronic disease management. Just-in-time adaptive interventions promise to deliver personalized, dynamic interventions directly to patients through use of push notifications from mobile devices. Although just-in-time adaptive interventions are a powerful tool for shaping health behavior, their application to cardiovascular disease management has been limited as they can be challenging to design. Herein, we provide a general overview and conceptual framework for microrandomized trials, a novel experimental study design that can be used to optimize just-in-time adaptive interventions. Microrandomized trials leverage mobile devices to sequentially randomize participants to types or levels of an intervention to determine the effectiveness of an intervention and time-varying moderators of those effects. Microrandomized trials are an efficient study design that can be used to determine which intervention components to include in just-in-time adaptive interventions and to optimize their decision rules while maintaining the strength of causal inference associated with traditional randomized controlled trials.",2021,"Just-in-time adaptive interventions promise to deliver personalized, dynamic interventions directly to patients through use of push notifications from mobile devices.",[],[],[],[],[],[],,0.0512822,"Just-in-time adaptive interventions promise to deliver personalized, dynamic interventions directly to patients through use of push notifications from mobile devices.","[{'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Golbus', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Internal Medicine (J.R.G., B.K.N.), University of Michigan, Ann Arbor.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Dempsey', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor (W.D.).'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Jackson', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, University of Alabama at Birmingham (E.A.J.).'}, {'ForeName': 'Brahmajee K', 'Initials': 'BK', 'LastName': 'Nallamothu', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Internal Medicine (J.R.G., B.K.N.), University of Michigan, Ann Arbor.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Klasnja', 'Affiliation': 'School of Information (P.K.), University of Michigan, Ann Arbor.'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.120.006760']
990,34583969,"Precision Patient Navigation to Improve Rates of Follow-up Colonoscopy, An Individual Randomized Effectiveness Trial.","BACKGROUND


Colorectal cancer screening by annual fecal immunochemical test (FIT) with follow-up on abnormal results is a cost-effective strategy to reduce colorectal cancer incidence and mortality. Unfortunately, many patients with abnormal results do not complete a follow-up colonoscopy. We tested whether navigation targeted to patients who are unlikely to complete the procedure may improve adherence and long-term outcomes.
METHODS


Study participants were patients at a large, integrated health system (Kaiser Permanente Northwest) who were ages 50 to 75 and were due for a follow-up colonoscopy after a recent abnormal FIT result. Probability of adherence to follow-up was estimated at baseline using a predictive risk model. Patients whose probability was 70% or lower were randomized to receive patient navigation or usual care, with randomization stratified by probability category (<50%, 50% < 60%, 60% < 65%, 65% ≤ 70%). We compared colonoscopy completion within 6 months between the navigation and usual care groups using Cox proportional hazards regression.
RESULTS


Participants ( n  = 415; 200 assigned to patient navigation, 215 to usual care) had a mean age of 62 years, 54% were female, and 87% were non-Hispanic white. By 6 months, 76% of the patient navigation group had completed a colonoscopy, compared with 65% of the usual care group (HR = 1.35; 95% confidence interval, 1.07-1.72; log-rank  P  value = 0.027).
CONCLUSIONS


In this randomized trial, patient navigation led to improvements in follow-up colonoscopy adherence.
IMPACT


More research is needed to assess the value of precision-directed navigation programs.",2021,"By six months, 76% of the patient navigation group had completed a colonoscopy, compared to 65% of the usual care group (HR=1.35, 95% CI: 1.07, 1.72; log-rank p-value: 0.027).
","['Study participants were patients at a large, integrated health system (Kaiser Permanente Northwest) who were aged 50-75 and were due for a follow-up colonoscopy after a recent abnormal FIT result', 'Participants (n = 415; 200 assigned to patient navigation, 215 to usual care) had a mean age of 62 years, 54% were female, and 87% were non-Hispanic white', 'Patients whose probability was 70% or lower']",['patient navigation or usual care'],['CRC incidence and mortality'],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C3494323', 'cui_str': 'Patient Navigation'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.07015,"By six months, 76% of the patient navigation group had completed a colonoscopy, compared to 65% of the usual care group (HR=1.35, 95% CI: 1.07, 1.72; log-rank p-value: 0.027).
","[{'ForeName': 'Gloria D', 'Initials': 'GD', 'LastName': 'Coronado', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon. Gloria.D.Coronado@kpchr.org.'}, {'ForeName': 'Andreea M', 'Initials': 'AM', 'LastName': 'Rawlings', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Petrik', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Slaughter', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Johnson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Peggy A', 'Initials': 'PA', 'LastName': 'Hannon', 'Affiliation': 'University of Washington School of Public Health, Seattle, Washington.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Cole', 'Affiliation': 'University of Washington School of Public Health, Seattle, Washington.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Vu', 'Affiliation': 'University of Washington School of Public Health, Seattle, Washington.'}, {'ForeName': 'Rajasekhara R', 'Initials': 'RR', 'LastName': 'Mummadi', 'Affiliation': 'Northwest Permanente Medicine, Portland, Oregon.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-20-1793']
991,34581443,Effect of methotrexate on melanoma risk in older adults: Secondary analysis of a randomised controlled trial.,,2022,,['older adults'],['methotrexate'],['melanoma risk'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.525962,,"[{'ForeName': 'Mabel K', 'Initials': 'MK', 'LastName': 'Yan', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA,, USA.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Mar', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}]",The Australasian journal of dermatology,['10.1111/ajd.13727']
992,34581297,TearCare for the Treatment of Meibomian Gland Dysfunction in Adult Patients With Dry Eye Disease: A Masked Randomized Controlled Trial.,"PURPOSE


The aim of this study was to demonstrate the safety and effectiveness of a single TearCare procedure compared with a single LipiFlow procedure in treatment of the dry eye disease associated with meibomian gland dysfunction.
METHODS


In a multicenter, masked, randomized controlled trial, 135 subjects received a single TearCare (TC) treatment (n = 67) or a single LipiFlow (LF) treatment (n = 68) at baseline and were followed up for 1 month posttreatment. Tear film breakup time, meibomian gland function, and corneal and conjunctival staining scores were assessed as dry eye signs at baseline, 2 weeks, and 1 month; dry eye symptoms were assessed using the Ocular Surface Disease Index, Symptom Assessment in Dry Eye, and eye dryness questionnaires at baseline and 1 month.
RESULTS


At 1 month posttreatment, both groups demonstrated significant improvements (P < 0.0001) in mean tear film breakup time and meibomian gland secretion score to 3.0 ± 4.4 and 11.2 ± 11.1 in the TC group and 2.6 ± 3.3 and 11.0 ± 10.4 in the LF group, respectively. The mean eye dryness, Symptom Assessment in Dry Eye, and Ocular Surface Disease Index scores were significantly reduced (P < 0.0001) by 35.4 ± 34.1, 38.2 ± 31.0, and 27.9 ± 20.5 in the TC group and 34.9 ± 26.9, 38.0 ± 25.9, and 23.4 ± 17.7 in the LF group, respectively. There were no statistically significant differences for any result between the groups. However, the TC group demonstrated numerically greater improvements consistently in all signs and symptoms. Device-related ocular adverse events were reported in 3 patients in the TC group (superficial punctate keratitis, chalazion, and blepharitis) and 4 patients in the LF group (blepharitis, 2 cases of foreign body sensation, and severe eye dryness).
CONCLUSIONS


A single TearCare treatment significantly alleviates the signs and symptoms of dry eye disease in patients with meibomian gland dysfunction and is equivalent in its safety and effectiveness profile to LipiFlow treatment as shown in this 1-month follow-up study.",2022,"At 1 month posttreatment, both groups demonstrated significant improvements (P < 0.0001) in mean tear film breakup time and meibomian gland secretion score to 3.0 ± 4.4 and 11.2 ± 11.1 in the TC group and 2.6 ± 3.3 and 11.0 ± 10.4 in the LF group, respectively.","['Adult Patients With Dry Eye Disease', '135 subjects received a', 'patients with meibomian gland dysfunction']","['single TearCare (TC) treatment', 'single LipiFlow procedure', 'TearCare', 'single LipiFlow (LF) treatment', 'single TearCare procedure']","['mean tear film breakup time and meibomian gland secretion score', 'signs and symptoms of dry eye disease', 'foreign body sensation, and severe eye dryness', 'Tear film breakup time, meibomian gland function, and corneal and conjunctival staining scores', 'Meibomian Gland Dysfunction', 'Ocular Surface Disease Index, Symptom Assessment in Dry Eye, and eye dryness questionnaires', 'mean eye dryness, Symptom Assessment in Dry Eye, and Ocular Surface Disease Index scores', 'Device-related ocular adverse events', 'safety and effectiveness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3203718', 'cui_str': 'Conjunctival staining'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",135.0,0.102035,"At 1 month posttreatment, both groups demonstrated significant improvements (P < 0.0001) in mean tear film breakup time and meibomian gland secretion score to 3.0 ± 4.4 and 11.2 ± 11.1 in the TC group and 2.6 ± 3.3 and 11.0 ± 10.4 in the LF group, respectively.","[{'ForeName': 'Preeya K', 'Initials': 'PK', 'LastName': 'Gupta', 'Affiliation': 'Cornea and Refractive Surgery, Duke University Eye Center, Durham, NC.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Holland', 'Affiliation': 'Cincinnati Eye Institute, Edgewood, KY.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hovanesian', 'Affiliation': 'Harvard Eye Associates, Laguna Hills, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Loh', 'Affiliation': 'Loh Ophthalmology Associates, Miami, FL.'}, {'ForeName': 'Mitchell A', 'Initials': 'MA', 'LastName': 'Jackson', 'Affiliation': 'Jacksoneye, Lake Villa, IL.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Karpecki', 'Affiliation': 'Kentucky Eye Institute, Lexington, KY; and.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Dhamdhere', 'Affiliation': 'Sight Sciences, Inc, Menlo Park, CA.'}]",Cornea,['10.1097/ICO.0000000000002837']
993,34580053,Prostate Cancer Screening with Magnetic Resonance Imaging: Results from the Second Round of the Göteborg Prostate Cancer Screening 2 Trial.,"BACKGROUND


The Göteborg 2 prostate cancer (PC) screening (G2) trial evaluates screening with prostate-specific antigen (PSA) followed by magnetic resonance imaging (MRI) in case of elevated PSA levels.
OBJECTIVE


To assess the safety of using a 2-yr interval in men who were previously screened positive with PSA but had negative MRI or positive MRI with a negative biopsy.
DESIGN, SETTING, AND PARTICIPANTS


A total of 61 201 men aged 50-60 yr were randomized and 38 366 were invited for screening (years 2015-2020). Men with positive MRI (Prostate Imaging Reporting and Data System [PI-RADS] score ≥3) were scheduled for targeted biopsies. Men with negative MRI or negative biopsies were reinvited after 2 yr. Round 1 and 2 MRI scans (PI-RADS ≥3) of men not diagnosed with PC in round 1 were re-read and classified according to Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) by two radiologists. Interval PCs (detected outside the program before invitation to round 2) were identified by linking to the Regional PC Registry.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Tabulation of overall detection of PC was done.
RESULTS AND LIMITATIONS


Between October 2017 and June 2020, 474 men with round 1 elevated PSA and MRI underwent a second screening. Of those, 19% had nonelevated PSA in round 2 and were not examined further. Of the remaining 376 men, 89% had negative MRI. Targeted biopsies yielded 14 PCs: nine grade group (GG) 1 and five GG 2-3. In men with PI-RADS ≥3 and PC diagnosed in round 2, only two (GG 1) progressed according to the PRECISE criteria and the remainder were stable. Ten interval PCs were diagnosed: seven GG 1, one GG 2, and two GG 5. The two GG 5 PCs were PI-RADS 4 and 5 with negative round 1 biopsy.
CONCLUSIONS


A 2-yr interval seems to be safe in men with negative MRI, while men with PI-RADS 4 and 5 lesions with negative biopsies should have a closer follow-up.
PATIENT SUMMARY


In prostate cancer screening, a 2-yr follow-up seems to be safe if magnetic resonance imaging did not show highly suspicious findings.",2022,Targeted biopsies yielded 14 PCs: nine grade group (GG) 1 and five GG 2-3.,"['A total of 61 201 men aged 50-60 yr were randomized and 38 366 were invited for screening (years 2015-2020', 'Men with negative MRI or negative biopsies', 'Of the remaining 376 men, 89% had negative MRI', 'Between October 2017 and June 2020, 474 men with round 1 elevated PSA and MRI underwent a second screening', 'men who were previously screened positive with PSA but had negative MRI or positive MRI with a negative biopsy', 'men with negative MRI, while men with PI-RADS 4 and 5 lesions with negative biopsies', 'Men with positive MRI (Prostate Imaging Reporting and Data System [PI-RADS] score ≥3) were scheduled for targeted biopsies']","['magnetic resonance imaging (MRI', 'Magnetic Resonance Imaging']","['nonelevated PSA', 'Interval PCs']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0406775', 'cui_str': 'Symmetrical dyschromatosis of extremities'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1622900', 'cui_str': 'Data Systems'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}]",61201.0,0.28533,Targeted biopsies yielded 14 PCs: nine grade group (GG) 1 and five GG 2-3.,"[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Wallström', 'Affiliation': 'Department of Radiology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Radiology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden. Electronic address: Jonas.wallstrom@gu.se.'}, {'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Geterud', 'Affiliation': 'Department of Radiology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Kimia', 'Initials': 'K', 'LastName': 'Kohestani', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Urology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Stephan E', 'Initials': 'SE', 'LastName': 'Maier', 'Affiliation': 'Department of Radiology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Radiology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Carl-Gustaf', 'Initials': 'CG', 'LastName': 'Pihl', 'Affiliation': 'Department of Pathology, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Socratous', 'Affiliation': 'Department of Radiology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Stranne', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Urology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Arnsrud-Godtman', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Urology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Månsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Hellström', 'Affiliation': 'Department of Radiology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Radiology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hugosson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Urology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.'}]",European urology oncology,['10.1016/j.euo.2021.09.001']
994,34585396,Ibudilast attenuates alcohol cue-elicited frontostriatal functional connectivity in alcohol use disorder.,"BACKGROUND


Ibudilast, a novel neuroimmune modulator being studied to treat alcohol use disorder (AUD), was shown in a randomized controlled trial (NCT03489850) to reduce ventral striatum (VS) activation in response to visual alcohol cues. The present study extended this finding by probing the effects of ibudilast on alcohol cue-elicited functional connectivity (i.e., temporally correlated activation) with the VS seed. The study also tests the association between functional connectivity and alcohol use during the trial.
METHODS


Non-treatment-seeking participants (n = 45) with current alcohol use disorder were randomized to receive twice-daily dosing with either ibudilast (50 mg; n = 20) or placebo (n = 25). Upon reaching the target dosagee of the medication or placebo, participants completed a functional neuroimaging alcohol cue reactivity paradigm. Drinks per drinking day were assessed at baseline and daily during the 2-week trial.
RESULTS


Ibudilast reduced alcohol cue-elicited functional connectivity between the VS seed and reward-processing regions including the orbitofrontal and anterior cingulate cortices compared with placebo (p < 0.05). Cue-elicited functional connectivity was correlated with drinks per drinking day (R 2   = 0.5351, p < 0.001), and ibudilast reduced this association in similar reward-processing regions compared with placebo.
CONCLUSIONS


Ibudilast's effects on drinking outcomes may be related to the attenuation of functional connectivity in frontostriatal circuits related to reward processing. These results provide an important proof of concept for this novel pharmacotherapy and support the clinical utility of incorporating neuroimaging-and especially functional connectivity-analyses into medication development.",2021,"Cue-elicited functional connectivity was correlated with drinks per drinking day (R 2   = 0.5351, p < 0.001), and ibudilast reduced this association in similar reward-processing regions compared with placebo.
",['Non-treatment-seeking participants (n\xa0=\xa045) with current alcohol use disorder'],['placebo'],"['alcohol cue-elicited functional connectivity', 'Cue-elicited functional connectivity']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.102161,"Cue-elicited functional connectivity was correlated with drinks per drinking day (R 2   = 0.5351, p < 0.001), and ibudilast reduced this association in similar reward-processing regions compared with placebo.
","[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Burnette', 'Affiliation': 'Department of Psychology, University of California at Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, University of California at Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Department of Psychology, University of California at Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Grodin', 'Affiliation': 'Department of Psychology, University of California at Los Angeles, Los Angeles, California, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14696']
995,34582445,"Factors associated with the prevalence of HIV, HSV-2, pregnancy, and reported sexual activity among adolescent girls in rural western Kenya: A cross-sectional analysis of baseline data in a cluster randomized controlled trial.","BACKGROUND


Adolescence is a sensitive time for girls' sexual and reproductive health (SRH), as biological changes occur concurrently with heightening pressures for sexual activity. In western Kenya, adolescent girls are vulnerable to acquiring sexually transmitted infections (STIs), such as HIV and herpes simplex virus type 2 (HSV-2), and to becoming pregnant prior to reaching adulthood. This study examines associations between individual, household, and partner-related risk factors and the prevalence of sex, adolescent pregnancy, HIV, and HSV-2.
METHODS AND FINDINGS


We report baseline findings among 4,138 girls attending secondary school who were enrolled between 2017 and 2018 in the Cups or Cash for Girls (CCG) cluster randomized controlled trial in Siaya County, rural western Kenya. Laboratory confirmed biomarkers and survey data were utilized to assess the effects of girls' individual, household, and partner characteristics on the main outcome measures (adolescent reported sex, prior pregnancy, HIV, and HSV-2) through generalized linear model (GLM) analysis. Complete data were available for 3,998 girls (97%) with median age 17.1 years (interquartile range [IQR] 16.3 to 18.0 years); 17.2% were HSV-2 seropositive (n = 686) and 1.7% tested positive for HIV (n = 66). Sexual activity was reported by 27.3% girls (n = 1,090), of whom 12.2% had been pregnant (n = 133). After adjustment, orphanhood (adjusted risk ratio [aRR] 2.81, 95% confidence interval [CI] 1.18 to 6.71, p-value [p] = 0.020), low body mass index (BMI) (aRR 2.07; CI: 1.00 to 4.30, p = 0.051), and age (aRR 1.34, 1.18 to 1.53, p < 0.001) were all associated with HIV infection. Girls reporting light menstrual bleeding (aRR 2.42, 1.22 to 4.79, p = 0.012) for fewer than 3 days (aRR 2.81, 1.16 to 6.82, p = 0.023) were over twice as likely to have HIV. Early menarche (aRR 2.05, 1.33 to 3.17, p = 0.001) was associated with adolescent pregnancy and HSV-2-seropositive girls reported higher rates of pregnancy (aRR 1.62, CI: 1.16 to 2.27, p = 0.005). High BMI was associated with HSV-2 (aRR 1.24, 1.05 to 1.46, p = 0.010) and sexual activity (aRR 1.14, 1.02 to 1.28, p = 0.016). High levels of harassment were detected in the cohort (41.2%); being touched indecently conveyed the strongest association related to reported sexual activity (aRR 2.52, 2.26 to 2.81, p < 0.001). Study limitations include the cross-sectional design of the study, which informs on the SRH burdens found in this population but limits causal interpretation of associations, and the self-reported exposure ascertainment, which may have led to possible underreporting of risk factors, most notably prior sexual activity.
CONCLUSIONS


Our findings indicate that adolescent girls attending school in Kenya face frequent harassment for sex and are at high risk of pregnancy and HSV-2, with girls experiencing early menarche particularly vulnerable. Targeted interventions, such as earlier sexual education programs, are warranted to address their vulnerability to SRH harms.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03051789.",2021,"Early menarche (aRR 2.05, 1.33 to 3.17, p = 0.001) was associated with adolescent pregnancy and HSV-2-seropositive girls reported higher rates of pregnancy (aRR 1.62, CI: 1.16 to 2.27, p = 0.005).","['adolescent girls attending school in Kenya', 'adolescent girls in rural western Kenya', '3,998 girls (97%) with median age 17.1 years (interquartile range [IQR] 16.3 to 18.0 years); 17.2% were HSV-2 seropositive (n = 686) and 1.7% tested positive for HIV (n = 66', '4,138 girls attending secondary school who were enrolled between 2017 and 2018 in the Cups or Cash for Girls (CCG) cluster randomized controlled trial in Siaya County, rural western Kenya']",[],"['Sexual activity', 'sexual activity', 'prevalence of HIV, HSV-2, pregnancy, and reported sexual activity', 'rates of pregnancy', 'High BMI', 'High levels of harassment', 'Girls reporting light menstrual bleeding', 'low body mass index (BMI']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0557295', 'cui_str': 'School attendance - finding'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0449572', 'cui_str': 'Virus type'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0557298', 'cui_str': 'Attending secondary school'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0449572', 'cui_str': 'Virus type'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0162790', 'cui_str': 'Sexual harassment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0231255', 'cui_str': 'Decreased body mass index'}]",4138.0,0.261198,"Early menarche (aRR 2.05, 1.33 to 3.17, p = 0.001) was associated with adolescent pregnancy and HSV-2-seropositive girls reported higher rates of pregnancy (aRR 1.62, CI: 1.16 to 2.27, p = 0.005).","[{'ForeName': 'Garazi', 'Initials': 'G', 'LastName': 'Zulaika', 'Affiliation': 'Liverpool School of Tropical Medicine (LSTM), Liverpool, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Nyothach', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'van Eijk', 'Affiliation': 'Liverpool School of Tropical Medicine (LSTM), Liverpool, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Obor', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mason', 'Affiliation': 'Liverpool School of Tropical Medicine (LSTM), Liverpool, United Kingdom.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Liverpool School of Tropical Medicine (LSTM), Liverpool, United Kingdom.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Liverpool School of Tropical Medicine (LSTM), Liverpool, United Kingdom.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Kerubo', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Valarie', 'Initials': 'V', 'LastName': 'Opollo', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Ngere', 'Affiliation': 'Ministry of Health, Siaya County, Kenya.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Omondi Owino', 'Affiliation': 'Ministry of Health, Siaya County, Kenya.'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Oyaro', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Feiko O', 'Initials': 'FO', 'LastName': 'Ter Kuile', 'Affiliation': 'Liverpool School of Tropical Medicine (LSTM), Liverpool, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kwaro', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Phillips-Howard', 'Affiliation': 'Liverpool School of Tropical Medicine (LSTM), Liverpool, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1003756']
996,34582427,Continuous Versus Routine Standardized Electroencephalogram for Outcome Prediction in Critically Ill Adults: Analysis From a Randomized Trial.,"OBJECTIVES


To investigate electroencephalogram (EEG) features' relation with mortality or functional outcome after disorder of consciousness, stratifying patients between continuous EEG and routine EEG.
DESIGN


Retrospective analysis of data from a randomized controlled trial.
SETTING


Multiple adult ICUs.
PATIENTS


Data from 364 adults with acute disorder of consciousness, randomized to continuous EEG (30-48 hr; n = 182) or repeated 20-minute routine electroencephalogram (n = 182).
INTERVENTIONS


None.
MEASUREMENTS AND MAIN RESULTS


Correlations between electrographic features and mortality and modified Rankin scale at 6 months (good 0-2) were assessed. Background continuity, higher frequency, and reactivity correlated with survival and good modified Rankin scale. Rhythmic and periodic patterns carried dual prognostic information: lateralized periodic discharges were associated with mortality and bad modified Rankin scale. Generalized rhythmic delta activity correlated with survival, good modified Rankin scale, and lower occurrence of status epilepticus. Presence of sleep-spindles and continuous EEG background was associated with good outcome in the continuous EEG subgroup. In the routine EEG group, a model combining background frequency, continuity, reactivity, sleep-spindles, and lateralized periodic discharges was associated with mortality at 70.91% (95% CI, 59.62-80.10%) positive predictive value and 63.93% (95% CI, 58.67-68.89%) negative predictive value. In the continuous EEG group, a model combining background continuity, reactivity, generalized rhythmic delta activity, and lateralized periodic discharges was associated with mortality at 84.62% (95%CI, 75.02-90.97) positive predictive value and 74.77% (95% CI, 68.50-80.16) negative predictive value.
CONCLUSIONS


Standardized EEG interpretation provides reliable prognostic information. Continuous EEG provides more information than routine EEG.",2022,Rhythmic and periodic patterns carried dual prognostic information: lateralized periodic discharges were associated with mortality and bad modified Rankin scale.,"['n = 182', 'Multiple adult ICUs', 'Critically Ill Adults', '364 adults with acute disorder of consciousness, randomized to continuous EEG (30-48 hr; n = 182) or']","['Continuous Versus Routine Standardized Electroencephalogram', 'repeated 20-minute routine electroencephalogram']","['electrographic features and mortality and modified Rankin scale', 'mortality and bad modified Rankin scale', 'model combining background frequency, continuity, reactivity, sleep-spindles, and lateralized periodic discharges', 'model combining background continuity, reactivity, generalized rhythmic delta activity, and lateralized periodic discharges', 'Generalized rhythmic delta activity correlated with survival, good modified Rankin scale, and lower occurrence of status epilepticus', ' continuity, higher frequency, and reactivity correlated with survival and good modified Rankin scale']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001314', 'cui_str': 'Acute disease'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0038220', 'cui_str': 'Status epilepticus'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]",364.0,0.102405,Rhythmic and periodic patterns carried dual prognostic information: lateralized periodic discharges were associated with mortality and bad modified Rankin scale.,"[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Beuchat', 'Affiliation': 'Department of Neurology, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Andrea O', 'Initials': 'AO', 'LastName': 'Rossetti', 'Affiliation': 'Department of Neurology, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Novy', 'Affiliation': 'Department of Neurology, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Schindler', 'Affiliation': 'Department of Neurology, Sleep-Wake-Epilepsy-Center, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Rüegg', 'Affiliation': 'Department of Neurology, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Alvarez', 'Affiliation': 'Department of Neurology, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.'}]",Critical care medicine,['10.1097/CCM.0000000000005311']
997,34591289,The involvement of axillary reverse mapping nodes in patients with clinically node-negative breast cancer.,"BACKGROUND


Axillary reverse mapping (ARM) was developed to preserve the lymphatic drainage from the upper arm during sentinel lymph-node (SLN) biopsy or axillary lymph-node dissection (ALND). However, the oncological safety of ARM has been controversial because of not infrequent involvement of ARM nodes.
METHODS


Patients with clinically negative nodes (cN0) underwent SLN biopsy and ARM. SLNs were identified using blue dye and radioisotope, and ARM nodes were traced using the fluorescent method. Patients with positive SLN underwent the standard ALND. After surgery, they were followed up for more than 3 years.
RESULTS


A total of 507 patients with cN0 breast cancer were enrolled between May 2009 and November 2017. SLNs were identified in 499 (98%) of 507 patients, and ARM nodes were identified in 159 (31%) patients in the SLN field. The crossover rate of SLN-ARM nodes was 28%. Among 95 patients with positive SLNs, 70 patients underwent conventional ALND. ARM nodes were identified in 65 (93%) of those patients in the ALND field. The mean number of removed ARM nodes was 7.2 (range 0-25) in patients who underwent the standard ALND. Although ARM nodes were involved in 18 of 65 patients, the involved ARM nodes were the same SLNs identified in 14 (78%) patients. Since SLN-ARM nodes should be removed, ARM nodes were involved only in 4 (5.7%) patients after SLN biopsy.
CONCLUSIONS


Except for positive SLN-ARM nodes, the involvement of ARM nodes is infrequent in patients with positive SLN.",2022,"SLNs were identified in 499 (98%) of 507 patients, and ARM nodes were identified in 159 (31%) patients in the SLN field.","['Patients with clinically negative nodes (cN0) underwent', 'patients with positive SLN', '507 patients with cN0 breast cancer were enrolled between May 2009 and November 2017', '95 patients with positive SLNs, 70 patients underwent', 'patients with clinically node-negative breast cancer', 'Patients with positive SLN underwent the standard ALND']","['SLN biopsy and ARM', 'conventional ALND', 'Axillary reverse mapping (ARM']","['ARM nodes', 'mean number of removed ARM nodes', 'SLNs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}]","[{'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}]","[{'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1883720', 'cui_str': 'Removes'}]",507.0,0.0577364,"SLNs were identified in 499 (98%) of 507 patients, and ARM nodes were identified in 159 (31%) patients in the SLN field.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Noguchi', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanazawa Medical University Hospital, Daigaku 1-1, Kahoku, Uchinada, Ishikawa, 920-0293, Japan. nogumasa@kanazawa-med.ac.jp.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Inokuchi', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanazawa Medical University Hospital, Daigaku 1-1, Kahoku, Uchinada, Ishikawa, 920-0293, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yokoi-Noguchi', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanazawa Medical University Hospital, Daigaku 1-1, Kahoku, Uchinada, Ishikawa, 920-0293, Japan.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Morioka', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanazawa Medical University Hospital, Daigaku 1-1, Kahoku, Uchinada, Ishikawa, 920-0293, Japan.'}]","Breast cancer (Tokyo, Japan)",['10.1007/s12282-021-01300-6']
998,34587231,Stimulated Insulin Secretion Predicts Changes in Body Composition Following Weight Loss in Adults with High BMI.,"BACKGROUND


The aim of obesity treatment is to promote loss of fat relative to lean mass. However, body composition changes with calorie restriction differ among individuals.
OBJECTIVES


The goal of this study was to test the hypothesis that insulin secretion predicts body composition changes among young and middle-age adults with high BMI (in kg/m2) following major weight loss.
METHODS


Exploratory analyses were conducted with pre-randomization data from 2 large feeding trials: the Framingham, Boston, Bloomington, Birmingham, and Baylor study (FB4; n = 82, 43.9% women, BMI ≥27) and the Framingham State Food Study [(FS)2; n = 161, 69.6% women, BMI ≥25]. Participants in the 2 trials consumed calorie-restricted moderate-carbohydrate or very-low-carbohydrate diets to produce 12-18% weight loss in ∼14 wk or 10-14% in ∼10 wk, respectively. We determined insulin concentration 30 min after a 75-g oral glucose load (insulin-30) as a measure of insulin secretion and HOMA-IR as a measure of insulin resistance at baseline. Body composition was determined by DXA at baseline and post-weight loss. Associations were analyzed using general linear models with adjustment for covariates.
RESULTS


In FB4, higher insulin-30 was associated with a smaller decrease in fat mass (0.441 kg per 100 μIU/mL increment in baseline insulin-30; P = 0.005; -1.20-kg mean difference between the first compared with the fifth group of insulin-30) and a larger decrease in lean mass (-0.465 kg per 100 μIU/mL; P = 0.004; 1.27-kg difference). Participants with higher insulin-30 lost a smaller proportion of weight loss as fat (-3.37% per 100 μIU/mL; P = 0.003; 9.20% difference). Greater HOMA-IR was also significantly associated with adverse body composition changes. Results from (FS)2 were qualitatively similar but of a smaller magnitude.
CONCLUSIONS


Baseline insulin dynamics predict substantial individual differences in body composition following weight loss. These findings may inform understanding of the pathophysiological basis for weight regain and the design of more effective obesity treatment. Registered at clinicaltrials.gov as NCT03394664 and NCT02068885.",2022,"In FB4, higher insulin-30 was associated with a smaller decrease in fat mass (0.441 kg per 100 μIU/mL increment in baseline","['Adults with High BMI', 'young and middle-age adults with high BMI (in kg/m2) following major weight loss', 'Exploratory analyses were conducted with pre-randomization data from 2 large feeding trials: the Framingham, Boston, Bloomington, Birmingham, and Baylor study (FB4; n\xa0']","['calorie-restricted moderate-carbohydrate or very-low-carbohydrate diets', 'insulin secretion']","['weight loss', 'Body composition', 'lean mass', 'insulin secretion and HOMA-IR as a measure of insulin resistance', 'fat mass', 'Greater HOMA-IR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0301577', 'cui_str': 'Carbohydrate diet'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",,0.152997,"In FB4, higher insulin-30 was associated with a smaller decrease in fat mass (0.441 kg per 100 μIU/mL increment in baseline","[{'ForeName': 'Julia M W', 'Initials': 'JMW', 'LastName': 'Wong', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Shui', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Mehta', 'Affiliation': 'Department of Health Services Administration, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Dickinson', 'Affiliation': 'Indiana University School of Public Health-Bloomington, Bloomington, IN, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Allison', 'Affiliation': 'Indiana University School of Public Health-Bloomington, Bloomington, IN, USA.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Heymsfield', 'Affiliation': 'Metabolism & Body Composition Laboratory, Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Cara B', 'Initials': 'CB', 'LastName': 'Ebbeling', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Ludwig', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Boston Children's Hospital, Boston, MA, USA.""}]",The Journal of nutrition,['10.1093/jn/nxab315']
999,34586954,Effects of radiotherapeutic X-ray irradiation on cervical enamel.,"PURPOSE


Therapeutic radiation used for head and neck cancers mainly affects the cervical region of the tooth. To better understand the impact of therapeutic radiation on tooth, we aimed to examine the crystallinity, micro-morphology, and elemental composition of the cervical inner enamel located adjacent to the dento-enamel junction.
MATERIALS AND METHODS


Ninety-one specimens obtained from 16 impacted third mandibular molars were randomly divided into seven groups (0, 10, 20, 30, 40, 50, and 60 Gy irradiation groups). Energy-dispersive X-ray spectroscopy (EDX) and scanning electron microscopy (SEM) were performed after the irradiation by 6 MV photon energy. The X-ray diffraction (XRD) were conducted in every group before and after irradiation. Elemental compositions, and Ca/P, P/N, Ca/N atomic ratios were subjected to the Shapiro-Wilk normality test. All of the elements except Mg showed a normal distribution and were compared by the one-way ANOVA. The non-normally distributed Mg data and Ca/P, P/N, and Ca/N ratios were compared by the Kruskal-Wallis test.
RESULTS


The results showed that widening in the interprismatic spaces were observed in the experimental groups subjected to 30 Gy and the following increased doses. In addition, there were no significant differences in C, O, Ca, P, N percentages between irradiated and non-irradiated groups ( p  > .05). An increase in atomic ratio of the Mg was detected after samples conducted by 60 Gy radiation dose ( p  < .05). The stoichiometric Ca/P, Ca/N, and P/N atomic ratios did not change by irradiation ( p  > .05). The XRD peaks of the inner enamel crystalline phase showed a slight decline in the 60 Gy radiation dose group.
CONCLUSION


Radiation effects begin to be seen after 30 Gy radiation dose groups. The widen interprismatic spaces seen obviously in 50 Gy and 60 Gy dose groups. Besides Mg ratio showed an increase in the 60 Gy dose group. But it should be thought that radiation caries is a multi-factorial disease that is in collaboration with various radiation-induced side effects.",2021,An increase in atomic ratio of the Mg was detected after samples conducted by 60 Gy radiation dose (p < 0.05).,"['head and neck cancers', 'Ninety-one specimens obtained from sixteen impacted third mandibular molars']","['radiotherapeutic X-ray irradiation', 'Energy-dispersive X-ray spectroscopy (EDX), and scanning electron microscopy (SEM']","['Elemental compositions, and Ca/P, P/N, Ca/N atomic ratios', 'C, O, Ca, P, N percentages', 'atomic ratio', 'crystallinity, micro-morphology, and elemental composition', 'cervical enamel', 'interprismatic spaces']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C2699997', 'cui_str': 'Energy Dispersive X-Ray Fluorescence Spectroscopy'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}]","[{'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]",,0.0421034,An increase in atomic ratio of the Mg was detected after samples conducted by 60 Gy radiation dose (p < 0.05).,"[{'ForeName': 'Yeşim', 'Initials': 'Y', 'LastName': 'Deniz', 'Affiliation': 'Department of Dentomaxillofacial Radiology, Faculty of Dentistry, Çanakkale Onsekiz Mart University, Çanakkale, Turkey.'}, {'ForeName': 'Çağatay', 'Initials': 'Ç', 'LastName': 'Aktaş', 'Affiliation': 'Department of Prosthodontics, Private Dental Clinic, Çanakkale, Turkey.'}, {'ForeName': 'Tuğba', 'Initials': 'T', 'LastName': 'Misilli', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Çanakkale Onsekiz Mart University, Çanakkale, Turkey.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Çarıkçıoğlu', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Çanakkale Onsekiz Mart University, Çanakkale, Turkey.'}]",International journal of radiation biology,['10.1080/09553002.2021.1987560']
1000,34590247,The Effect of the FIFA 11 + with Added Neck Exercises on Maximal Isometric Neck Strength and Peak Head Impact Magnitude During Heading: A Pilot Study.,"BACKGROUND


Higher neck strength has been postulated to reduce head impact magnitude during purposeful heading in football.
OBJECTIVES


This pilot trial explored the effect of a neck exercise programme on (1) neck strength and (2) head impact magnitude during heading in male and female adolescent football players.
METHODS


Boys and girls (aged 12-17 years) were randomised by team to the intervention (5 weeks of supervised neuromuscular neck exercises integrated into part 2 of the FIFA 11 + , completed three times per week) or the control group (usual part 2 of the FIFA 11 + , no neck exercises). Outcomes included isometric neck strength and head impact magnitude (peak linear acceleration and peak angular velocity) during standardised heading from a throw-in (at baseline and 6 weeks) plus completion of an evaluation survey by intervention players and coaches.
RESULTS


In total, 52 players (n = 31 intervention; n = 21 control) completed the study. Mixed-model analysis of variance (ANOVA) revealed significant differences in neck strength variables (p < 0.001), peak linear acceleration (p = 0.04) and peak angular velocity (p = 0.04) between the intervention and control groups over time. Intervention players demonstrated increases in mean composite neck strength (53.8% intervention vs 15.6% control) as well as decreases in mean peak linear head acceleration during heading (- 11.8% vs - 5.0%) from baseline to follow-up. Reduction in peak angular velocity was more pronounced in girls (- 27.7%) than boys (- 11.5%) in the intervention group. The addition of neck exercises into part 2 of the FIFA 11 + was feasible and accepted by players and coaches.
CONCLUSION


On average, players who completed neck exercises demonstrated an increase in isometric neck strength and a decrease in head impact magnitude during heading. These exercises were easily incorporated into usual training. Australian New Zealand Clinical Trials Registry (no: ACTRN12619001375145).",2022,"On average, players who completed neck exercises demonstrated an increase in isometric neck strength and a decrease in head impact magnitude during heading.","['52 players (n\u2009=\u200931 intervention; n\u2009=\u200921 control) completed the study', 'Boys and girls (aged 12-17\xa0years', 'male and female adolescent football players']","['neck exercise programme', 'supervised neuromuscular neck exercises integrated into part 2 of the FIFA 11\u2009+\u2009, completed three times per week) or the control group (usual part 2 of the FIFA 11\u2009+\u2009, no neck exercises', 'FIFA 11\u2009+\u2009with Added Neck Exercises']","['Maximal Isometric Neck Strength', 'isometric neck strength', 'neck strength variables', 'mean composite neck strength', 'isometric neck strength and head impact magnitude (peak linear acceleration and peak angular velocity', 'mean peak linear head acceleration during heading', 'peak angular velocity', 'peak linear acceleration']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}]","[{'cui': 'C0454347', 'cui_str': 'Neck exercises'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",52.0,0.0153378,"On average, players who completed neck exercises demonstrated an increase in isometric neck strength and a decrease in head impact magnitude during heading.","[{'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Peek', 'Affiliation': 'Discipline of Physiotherapy, School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Susan Wakil Health Building, Camperdown, Sydney, NSW, Australia. Kerry.Peek@sydney.edu.au.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Andersen', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Marnee J', 'Initials': 'MJ', 'LastName': 'McKay', 'Affiliation': 'Discipline of Physiotherapy, School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Susan Wakil Health Building, Camperdown, Sydney, NSW, Australia.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Versteegh', 'Affiliation': 'School of Physical Therapy, Western University, London, ON, Canada.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Gilchrist', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Institute of Sports and Preventive Medicine, Medical Faculty, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gardner', 'Affiliation': 'Priority Research Centre for Stroke and Brain Injury, School of Medicine and Public Health, The University of Newcastle, Newcastle, NSW, Australia.'}]","Sports medicine (Auckland, N.Z.)",['10.1007/s40279-021-01564-0']
1001,34590519,A new protocol for exercise testing in COPD; improved prediction algorithm for  W MAX  and validation of the endurance test in a placebo-controlled double bronchodilator study.,"BACKGROUND


Two new protocols have been developed for bicycle exercise testing in chronic obstructive pulmonary disease (COPD) with an individualized cardiopulmonary exercise test (ICPET) and subsequent customized endurance test (CET), which generate less interindividual spread in endurance time compared with the standard endurance test. Main objectives of this study were to improve the prediction algorithm for  W MAX  for the ICPET and validate the CET by examining treatment effects on exercise performance of indacaterol/glycopyrronium (IND/GLY) compared with placebo.
METHODS


COPD patients, with forced expiratory volume in 1 s ( FEV 1 ) 40-80% predicted, were recruited. Pooled baseline data from two previous studies ( n  = 38) were used for the development of an improved  W MAX  prediction algorithm. Additional COPD patients ( n  = 14) were recruited and performed the ICPET, using the new prediction formula at visit 1. Prior to the CET at visits 2 and 3, they were randomized to a single dose of IND/GLY (110/50 µg) or placebo.
RESULTS


The improved multiple regression algorithm for  W MAX  includes diffusing capacity for carbon monoxide ( DLCO ),  FEV 1 ,  sex ,  age  and  height  and correlated to measured  W MAX  ( R 2  = 0.89 and slope = 0.89). Treatment with IND/GLY showed improvement in endurance time  versus  placebo, mean 113 s [95% confidence interval (CI): 6-220],  p  = 0.037, with more prominent effect in patients with  FEV 1  < 70% predicted.
CONCLUSION


The two new protocols for ICPET (including the new improved algorithm) and CET were retested with consistent results. In addition, the CET showed a significant and clinically relevant prolongation of endurance time for IND/GLY  versus  placebo in a small number of patients.",2021,"GLY showed improvement in endurance time  versus  placebo, mean 113 s [95% confidence interval (CI):","['chronic obstructive pulmonary disease (COPD', 'patients with', 'COPD patients, with forced expiratory volume in 1 s ( FEV 1 ) 40-80% predicted, were recruited', 'Additional COPD patients ( n \u2009=\u200914']","['CET', 'bicycle exercise testing', 'indacaterol/glycopyrronium (IND/GLY', 'individualized cardiopulmonary exercise test (ICPET) and subsequent customized endurance test (CET', 'placebo', 'ICPET']","['diffusing capacity for carbon monoxide ( DLCO ),  FEV 1 ,  sex ,  age  and  height', 'endurance time']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280474', 'cui_str': 'Transfer factor (respiratory measure)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.468298,"GLY showed improvement in endurance time  versus  placebo, mean 113 s [95% confidence interval (CI):","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Tufvesson', 'Affiliation': 'Respiratory Medicine and Allergology, Department of Clinical Sciences, Lund, Lund University, Skane University Hospital, 221 85 Lund, Sweden.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Radner', 'Affiliation': 'Respiratory Medicine and Allergology, Department of Clinical Sciences, Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Simonsen', 'Affiliation': 'Respiratory Medicine and Allergology, Department of Clinical Sciences, Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Papapostolou', 'Affiliation': 'Respiratory Medicine and Allergology, Department of Clinical Sciences, Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Jarenbäck', 'Affiliation': 'Respiratory Medicine and Allergology, Department of Clinical Sciences, Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Saga', 'Initials': 'S', 'LastName': 'Jönsson', 'Affiliation': 'Respiratory Medicine and Allergology, Department of Clinical Sciences, Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Nihlen', 'Affiliation': 'Respiratory Medicine and Allergology, Department of Clinical Sciences, Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Alf', 'Initials': 'A', 'LastName': 'Tunsäter', 'Affiliation': 'Respiratory Medicine and Allergology, Department of Clinical Sciences, Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Jaro', 'Initials': 'J', 'LastName': 'Ankerst', 'Affiliation': 'Respiratory Medicine and Allergology, Department of Clinical Sciences, Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Peterson', 'Affiliation': 'Regional Cancer Centre South, Region Skane, Lund, Sweden.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Bjermer', 'Affiliation': 'Respiratory Medicine and Allergology, Department of Clinical Sciences, Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Eriksson', 'Affiliation': 'Respiratory Medicine and Allergology, Department of Clinical Sciences, Lund, Lund University, Skane University Hospital, Lund, Sweden.'}]",Therapeutic advances in respiratory disease,['10.1177/17534666211037454']
1002,34592049,Patients' self-reported physical and psychological effects of opioid use in chronic noncancer pain-A retrospective cross-sectional analysis.,"BACKGROUND


Strong opioids can have unintended effects. Clinical studies of strong opioids mainly report physical side effects, psychiatric or opioid use disorders. To date, too little attention has been paid to the psychological effects of opioids to treat patients with chronic noncancer pain (CNCP). This study aims to identify and measure (i) the nature and frequency of physical and psychological effects and (ii) the degree of physician counseling of patients with CNCP taking strong opioids.
METHODS


Within a cross-sectional survey-conducted as part of a randomised controlled online intervention trial (ERONA [Experiencing the risk of overusing opioids among patients with chronic non-cancer pain in ambulatory care])-300 German CNCP patients were surveyed via patient-reported outcome measures regarding on both the side effects from their use of strong opioids as well as their counselling experience.
RESULTS


Among the patients' reported effects, the psychological outcomes of the opioids in CNCP were: feeling relaxed (84%), fatigue (76%), dizziness (57%), listlessness (37%), difficulty with mental activities (23%), dulled emotions (17%) and poor memory (17%). Ninety-two per cent of the patients reported having received information about opioid effects, and 46% had discussed cessation of the opioid medication with their physicians before commencing the prescription.
CONCLUSIONS


In addition to the well-known physical side effects, patients with CNCP taking strong opioids experience significant psychological effects. In view of these effects, discontinuation of opioid therapy should be discussed early to ensure their benefits do not outweigh their harm.
SIGNIFICANCE


In this study, patients with non-cancer pain notice that opioids they have taken do not only cause physical side effects but also may have an impact on their psyche and their emotions and, thus, may also affect quality of life substantially. Clinical trial number: DRKS00020358.",2022,"To date, too little attention has been paid to the psychological effects of opioids to treat patients with chronic noncancer pain (CNCP).","['300 German CNCP patients', 'patients with chronic noncancer pain taking strong opioids', 'patients with chronic noncancer pain (CNCP']",[],"['fatigue', 'listlessness', 'dulled emotions', 'dizziness', 'difficulty with mental activities']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",[],"[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0278144', 'cui_str': 'Dull pain'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",300.0,0.0209454,"To date, too little attention has been paid to the psychological effects of opioids to treat patients with chronic noncancer pain (CNCP).","[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Schulte', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Spies', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Denke', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Joerg J', 'Initials': 'JJ', 'LastName': 'Meerpohl', 'Affiliation': 'Institute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center & Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Donner-Banzhoff', 'Affiliation': 'Department of Primary Care, Phillips University Marburg, Marburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Petzke', 'Affiliation': 'Pain Clinic, Department of Anesthesiology, Universitätsmedizin Göttingen, Göttingen, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Hertwig', 'Affiliation': 'Center for Adaptive Rationality, Max-Planck-Institut für Bildungsforschung, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schäfer', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Wegwarth', 'Affiliation': 'Center for Adaptive Rationality, Max-Planck-Institut für Bildungsforschung, Berlin, Germany.'}]","European journal of pain (London, England)",['10.1002/ejp.1868']
1003,34592862,Long-term maintenance treatment with 300 mg thiamine for fatigue in patients with inflammatory bowel disease: results from an open-label extension of the TARIF study.,"OBJECTIVE AND AIMS


Fatigue is common in inflammatory bowel disease (IBD). In a RCT we demonstrated reductions in fatigue after 4 weeks' treatment with high-dose oral thiamine. We aimed to investigate whether 300 mg thiamine daily for 12 weeks could maintain the achieved levels of fatigue in patients with IBD after a 4-week intervention with high-dose thiamine; and evaluate the effect of a 6-month period where patients were free to take oral thiamine.
METHODS


A randomised, open-label, controlled trial, performed as a long-term extension (LTE) study of an initial randomised, high-dose thiamine trial. Patients were allocated 1:1 to 300 mg oral thiamine or no thiamine for 12 weeks. Subsequently, the patients were allowed to self-treat with over-the-counter (OTC) oral thiamine 6-month.
RESULTS


Regardless of allocation in the LTE study fatigue severity increased in the study period. No significant effect of 300 mg oral thiamine were found, when stratifying for initial allocation in the high-dose study or fatigue level at entry in the LTE study. Patients who took OTC thiamine had lower level of fatigue 6 month later (7.8; 95% CI: 5.5-10.1) when compared to the remains (11.0; 95% CI: 9.2-12.8) ( p  = .02). After the 6-months follow-up without restrictions, 66% of patients had reached normal fatigue levels.
CONCLUSIONS


We found no beneficial effect on fatigue from thiamine taken in doses of 300 mg per day for 12 weeks following high-dose treatment. After a 6-months follow-up without restrictions 66% had reached a normal level of fatigue.
CLINICAL TRIAL REGISTRATION


The trial was registered at ClinicalTrials.gov under study identifier NCT03634735.",2022,Patients who took OTC thiamine had lower level of fatigue 6 month later (7.8; 95% CI: 5.5-10.1) when compared to the remains (11.0; 95% CI: 9.2-12.8) ( p  = .02).,"['patients with inflammatory bowel disease', 'patients with IBD after a']","['thiamine', '300\u2009mg thiamine', '4-week intervention with high-dose thiamine', 'OTC thiamine', 'oral thiamine or no thiamine', 'oral thiamine']","['normal fatigue levels', 'fatigue severity', 'fatigue', 'lower level of fatigue 6\u2009month later', 'normal level of fatigue', 'levels of fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}]","[{'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",,0.410111,Patients who took OTC thiamine had lower level of fatigue 6 month later (7.8; 95% CI: 5.5-10.1) when compared to the remains (11.0; 95% CI: 9.2-12.8) ( p  = .02).,"[{'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Bager', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Christian Lodberg', 'Initials': 'CL', 'LastName': 'Hvas', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Charlotte Lock', 'Initials': 'CL', 'LastName': 'Rud', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Jens Frederik', 'Initials': 'JF', 'LastName': 'Dahlerup', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus N, Denmark.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2021.1983640']
1004,34592854,Development and validation of a novel nomogram for predicting survival rate in pancreatic neuroendocrine neoplasms.,"BACKGROUND


Over the past decades, the incidence and prevalence of pancreatic neuroendocrine neoplasms (pNENs) have steadily increased. However, accurate prediction of the prognosis and treatment of this condition are currently challenging. This study aims to develop and validate a personalized nomogram to predict the survival of patients with pNENs.
MATERIALS AND METHODS


A total of 9739 patients with pNENs were downloaded from the Surveillance, Epidemiology, and End Results (SEER) database. Subsequently, the patients were randomly assigned to a derivation cohort ( n  = 6874) and a validation cohort ( n  = 2865). The survival of patients was assessed using the Cox proportional hazards (PHs) regression analysis. Then, the nomogram that predicted 3-and 5-year survival rates were developed in the derivation cohort. Further, the predictive performance of the nomogram was evaluated through discrimination and calibration.
RESULTS


The Cox regression analysis revealed that age, differentiation, the extent of tumor, M staging, and surgery were independent prognostic predictors for pNENs. The nomogram showed superior discrimination capability than AJCC staging in both derived and validation cohorts (C-index: 0.874 versus 0.721 and 0.833 versus 0.721). The calibration curves showed that the practical and predicted survival rates effectively coincided, specifically for the 3-year survival rate.
CONCLUSION


Our nomogram is a valuable tool for the prediction of the survival rate for patients with pNENs; this may promote individualized prognostic evaluation and treatment.",2022,"The calibration curves showed that the practical and predicted survival rates effectively coincided, specifically for the 3-year survival rate.
","['9739 patients with pNENs', 'patients with pNENs', 'pancreatic neuroendocrine neoplasms']",[],"['3-and 5-year survival rates', 'survival rate', '3-year survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242363', 'cui_str': 'Pancreatic endocrine tumor'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",9739.0,0.124475,"The calibration curves showed that the practical and predicted survival rates effectively coincided, specifically for the 3-year survival rate.
","[{'ForeName': 'Tianbao', 'Initials': 'T', 'LastName': 'Liao', 'Affiliation': ""Department of President's Office, Youjiang Medical University for Nationalities, Baise, China.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Su', 'Affiliation': ""Department of ECG Diagnostics, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.""}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Comprehensive Internal Medicine, Guangxi Medical University Cancer Hospital, Nanning, China.'}, {'ForeName': 'Bixun', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Comprehensive Internal Medicine, Guangxi Medical University Cancer Hospital, Nanning, China.'}, {'ForeName': 'Lu-Huai', 'Initials': 'LH', 'LastName': 'Feng', 'Affiliation': 'Department of Comprehensive Internal Medicine, Guangxi Medical University Cancer Hospital, Nanning, China.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2021.1984571']
1005,34588210,The Effect of Discontinuing Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin.,"OBJECTIVE


To explore the effect of discontinuing continuous glucose monitoring (CGM) after 8 months of CGM use in adults with type 2 diabetes treated with basal without bolus insulin.
RESEARCH DESIGN AND METHODS


This multicenter trial had an initial randomization to either real-time CGM or blood glucose monitoring (BGM) for 8 months followed by 6 months in which the BGM group continued to use BGM ( n  = 57) and the CGM group was randomly reassigned either to continue CGM ( n  = 53) or discontinue CGM with resumption of BGM for glucose monitoring ( n  = 53).
RESULTS


In the group that discontinued CGM, mean time in range (TIR) 70-180 mg/dL, which improved from 38% before initiating CGM to 62% after 8 months of CGM, decreased after discontinuing CGM to 50% at 14 months (mean change from 8 to 14 months -12% [95% CI -21% to -3%],  P  = 0.01). In the group that continued CGM use, little change was found in TIR from 8 to 14 months (baseline 44%, 8 months 56%, 14 months 57%, mean change from 8 to 14 months 1% [95% CI -11% to 12%],  P  = 0.89). Comparing the two groups at 14 months, the adjusted treatment group difference in mean TIR was -6% (95% CI -16% to 4%,  P  = 0.20).
CONCLUSIONS


In adults with type 2 diabetes treated with basal insulin who had been using real-time CGM for 8 months, discontinuing CGM resulted in a loss of about one-half of the initial gain in TIR that had been achieved during CGM use.",2021,"In the group that continued CGM use, little change was found in TIR from 8 to 14 months (baseline 44%, 8 months 56%, 14 months 57%, mean change from 8 to 14 months 1% [95% CI -11% to 12%],  P  = 0.89).","['adults with type 2 diabetes treated with basal without bolus insulin', 'Adults With Type 2 Diabetes Treated With Basal Insulin', 'adults with type 2 diabetes treated with']","['basal insulin', 'real-time CGM or blood glucose monitoring (BGM', 'Discontinuing Continuous Glucose Monitoring', 'CGM group was randomly reassigned either to continue CGM', 'discontinuing continuous glucose monitoring (CGM', 'discontinue CGM with resumption of BGM for glucose monitoring']","['mean TIR', 'mean time in range (TIR', 'TIR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}]",,0.0417287,"In the group that continued CGM use, little change was found in TIR from 8 to 14 months (baseline 44%, 8 months 56%, 14 months 57%, mean change from 8 to 14 months 1% [95% CI -11% to 12%],  P  = 0.89).","[{'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Aleppo', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL rbeck@jaeb.org.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Bailey', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Ruedy', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Peters', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA.'}, {'ForeName': 'Shichun', 'Initials': 'S', 'LastName': 'Bao', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Umpierrez', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Davida', 'Initials': 'D', 'LastName': 'Kruger', 'Affiliation': 'Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Bhargava', 'Affiliation': 'Iowa Diabetes Research, West Des Moines, IA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Young', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Janet B', 'Initials': 'JB', 'LastName': 'McGill', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Martens', 'Affiliation': 'International Diabetes Center, Park Nicollet Internal Medicine, Minneapolis, MN.'}, {'ForeName': 'Quang T', 'Initials': 'QT', 'LastName': 'Nguyen', 'Affiliation': 'Las Vegas Endocrinology, Henderson, NV.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Orozco', 'Affiliation': 'Carteret Medical Group, Morehead City, NC.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Biggs', 'Affiliation': 'Amarillo Medical Specialists, Amarillo, TX.'}, {'ForeName': 'K Jean', 'Initials': 'KJ', 'LastName': 'Lucas', 'Affiliation': 'Diabetes and Endocrinology Consultants, PC, Morehead City, NC.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Polonsky', 'Affiliation': 'Behavioral Diabetes Institute, San Diego, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Dexcom, Inc., San Diego, CA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc21-1304']
1006,34592023,Effectiveness of self-myofascial release combined with biofeedback and electrical stimulation for the management of myofascial pelvic pain: A randomized controlled trial.,"BACKGROUND


Myofascial pelvic pain (MFPP) caused by myofascial trigger points (MTrPs) is a major contributor to chronic pelvic pain in women. However, the effect of the patient's self-myofascial release (SMFR) is unclear. This study aimed to investigate the effect of SMFR combined with biofeedback and electrical stimulation (BES) therapy in comparison with BES alone in patients with MFPP.
METHODS


A prospective randomized controlled study was conducted. Sixty-eight patients were randomly allocated into BES-SMFR group (n = 34) and BES group (n = 34). Every patient received 4 weeks of treatment, evaluated at baseline (T0), 4 weeks post-intervention (T4) and 12-week follow-up (T12). The primary outcome was pain intensity. The secondary outcomes were degree of activation of MTrPs, surface electromyography (sEMG) levels and Patient Global Impression of Improvement (PGI-I).
RESULTS


Compared with the effect of BES, BES-SMFR treatment significantly decreased pain intensity and the degree of activation of MTrPs in the levator ani (p = 0.02) and obturator internus (p = 0.03), as well as the sEMG levels of the pre-test resting baseline and post-test resting baseline (all p < 0.01). The degree of activation of MTrPs in the piriformis and coccygeus (all p > 0.05) and the sEMG levels of the quick flicks and endurance contraction were not significantly different. The BES-SMFR treatment improved the PGI-I scale at T4 (p = 0.02) but not at T12 (p = 0.40).
CONCLUSIONS


This study confirmed that the addition of SMFR to BES treatment resulted in superior outcomes compared with those with BES alone in patients with MFPP.
SIGNIFICANCE STATEMENT


Myofascial pelvic pain (MFPP) is a major contributor of female chronic pelvic pain. Myofascial release has been used commonly for better pain release; however, poor therapeutic effect due to poor patient compliance is common in clinical practice. Therefore, in future research, there is a need to investigate the effect of patient's self-myofascial release (SMFR) technique, which can eliminate the need for frequent office visits and improve patient compliance to some extent, in patients with MFPP.",2022,"The BES-SMFR treatment improved the PGI-I scale at T4 (P = 0.02) but not at T12 (P = 0.40).
","['chronic pelvic pain in women', 'myofascial pelvic pain', 'Sixty-eight patients', 'patients with MFPP']","['BES, BES-SMFR', 'self-myofascial release combined with biofeedback and electrical stimulation', 'BES', 'BES-SMFR', 'SMFR combined with biofeedback and electrical stimulation (BES) therapy']","['sEMG levels', 'pain intensity and the degree of activation of MTrPs', 'PGI-I scale', 'sEMG levels of the quick flicks and endurance contraction', 'degree of activation of MTrPs, surface electromyography (sEMG) levels, and patient global impression of improvement (PGI-I', 'pain intensity', 'degree of activation of MTrPs']","[{'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]",68.0,0.0519495,"The BES-SMFR treatment improved the PGI-I scale at T4 (P = 0.02) but not at T12 (P = 0.40).
","[{'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Obstetrics and Gynecology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Section of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Howard University Hospital, Howard University College of Medicine, Washington, District of Columbia, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Department of Obstetrics and Gynecology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Mingyue', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Department of Obstetrics and Gynecology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Mulan', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': 'Department of Obstetrics and Gynecology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Obstetrics and Gynecology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, Jiangsu, China.'}]","European journal of pain (London, England)",['10.1002/ejp.1867']
1007,34587830,Repetitive Peripheral Sensory Stimulation as an Add-On Intervention for Upper Limb Rehabilitation in Stroke: A Randomized Trial.,"INTRODUCTION


Repetitive peripheral sensory stimulation (RPSS) followed by 4-hour task-specific training (TST) improves upper limb motor function in subjects with stroke who experience moderate to severe motor upper limb impairments. Here, we compared effects of RPSS vs sham followed by a shorter duration of training in subjects with moderate to severe motor impairments in the chronic phase after stroke.
METHODS


This single-center, randomized, placebo-controlled, parallel-group clinical trial compared effects of 18 sessions of either 1.5 h of active RPSS or sham followed by a supervised session that included 45 min of TST of the paretic upper limb. In both groups, subjects were instructed to perform functional tasks at home, without supervision. The primary outcome measure was the Wolf Motor Function Test (WMFT) after 6 weeks of treatment. Grasp and pinch strength were secondary outcomes.
RESULTS


In intention-to-treat analysis, WMFT improved significantly in both active and sham groups at 3 and 6 weeks of treatment. Grasp strength improved significantly in the active, but not in the sham group, at 3 and 6 weeks. Pinch strength improved significantly in both groups at 3 weeks, and only in the active group at 6 weeks.
CONCLUSIONS


The between-group difference in changes in WMFT was not statistically significant. Despite the short duration of supervised treatment, WMFT improved significantly in subjects treated with RPSS or sham. These findings are relevant to settings that impose constraints in duration of direct contact between therapists and patients. In addition, RPSS led to significant gains in hand strength.Trial Registry Name: Peripheral Nerve Stimulation and Motor Training in Stroke Clinical Trials.gov identifier: NCT0265878 https://clinicaltrials.gov/ct2/show/NCT02658578.",2021,"In intention-to-treat analysis, WMFT improved significantly in both active and sham groups at 3 and 6 weeks of treatment.","['subjects with stroke who experience moderate to severe motor upper limb impairments', 'subjects with moderate to severe motor impairments in the chronic phase after stroke', 'Upper Limb Rehabilitation in Stroke']","['RPSS', 'placebo', 'Repetitive Peripheral Sensory Stimulation', 'Repetitive peripheral sensory stimulation (RPSS) followed by 4-hour task-specific training (TST']","['Pinch strength', 'Grasp and pinch strength', 'Grasp strength', 'changes in WMFT', 'Wolf Motor Function Test (WMFT']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0150763', 'cui_str': 'Sensory stimulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0930993,"In intention-to-treat analysis, WMFT improved significantly in both active and sham groups at 3 and 6 weeks of treatment.","[{'ForeName': 'Adriana B', 'Initials': 'AB', 'LastName': 'Conforto', 'Affiliation': 'Neurology Clinical Division, Hospital Das Clínicas, 117265São Paulo University and Fundação Faculdade de Medicina, São Paulo, Brazil.'}, {'ForeName': 'André G', 'Initials': 'AG', 'LastName': 'Machado', 'Affiliation': 'Departament of Neurosciences, 2569Lerner Reasearch Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Nathalia H V', 'Initials': 'NHV', 'LastName': 'Ribeiro', 'Affiliation': 'Neurology Clinical Division, Hospital Das Clínicas, 117265São Paulo University and Fundação Faculdade de Medicina, São Paulo, Brazil.'}, {'ForeName': 'Ela B', 'Initials': 'EB', 'LastName': 'Plow', 'Affiliation': 'Departament of Neurosciences, 2569Lerner Reasearch Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Sook-Lei', 'Initials': 'SL', 'LastName': 'Liew', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, Biokinesiology and Physical Therapy, Biomedical Engineering, and Neurology; USC Stevens Neuroimaging and Informatics Institute, 5116University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'da Costa Leite', 'Affiliation': 'Núcleo de Apoio à Pesquisa Em Neurociências (Center for Interdisciplinary Research on Applied Neurosciences: NAPNA), São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'Artemis', 'Initials': 'A', 'LastName': 'Zavaliangos-Petropulu', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, Biokinesiology and Physical Therapy, Biomedical Engineering, and Neurology; USC Stevens Neuroimaging and Informatics Institute, 5116University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Menezes', 'Affiliation': 'Neurology Clinical Division, Hospital Das Clínicas, 117265São Paulo University and Fundação Faculdade de Medicina, São Paulo, Brazil.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Dos Anjos', 'Affiliation': 'School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Luccas', 'Affiliation': 'Neurology Clinical Division, Hospital Das Clínicas, 117265São Paulo University and Fundação Faculdade de Medicina, São Paulo, Brazil.'}, {'ForeName': 'Paul Hunter', 'Initials': 'PH', 'LastName': 'Peckham', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Leonardo G', 'Initials': 'LG', 'LastName': 'Cohen', 'Affiliation': 'Human Cortical Physiology and Stroke Neurorehabilitation Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}]",Neurorehabilitation and neural repair,['10.1177/15459683211046259']
1008,34592318,"Study of Alteplase for Respiratory Failure in SARS-CoV-2 COVID-19: A Vanguard Multicenter, Rapidly Adaptive, Pragmatic, Randomized Controlled Trial.","BACKGROUND


Pulmonary vascular microthrombi are a proposed mechanism of COVID-19 respiratory failure. We hypothesized that early administration of tissue plasminogen activator (tPA) followed by therapeutic heparin would improve pulmonary function in these patients.
RESEARCH QUESTION


Does tPA improve pulmonary function in severe COVID-19 respiratory failure, and is it safe?
STUDY DESIGN AND METHODS


Adults with COVID-19-induced respiratory failure were randomized from May14, 2020 through March 3, 2021, in two phases. Phase 1 (n = 36) comprised a control group (standard-of-care treatment) vs a tPA bolus (50-mg tPA IV bolus followed by 7 days of heparin; goal activated partial thromboplastin time [aPTT], 60-80 s) group. Phase 2 (n = 14) comprised a control group vs a tPA drip (50-mg tPA IV bolus, followed by tPA drip 2 mg/h plus heparin 500 units/h over 24 h, then heparin to maintain aPTT of 60-80 s for 7 days) group. Patients were excluded from enrollment if they had not undergone a neurologic examination or cross-sectional brain imaging within the previous 4.5 h to rule out stroke and potential for hemorrhagic conversion. The primary outcome was Pao 2  to Fio 2  ratio improvement from baseline at 48 h after randomization. Secondary outcomes included Pao 2  to Fio 2  ratio improvement of > 50% or Pao 2  to Fio 2  ratio of ≥ 200 at 48 h (composite outcome), ventilator-free days (VFD), and mortality.
RESULTS


Fifty patients were randomized: 17 in the control group and 19 in the tPA bolus group in phase 1 and eight in the control group and six in the tPA drip group in phase 2. No severe bleeding events occurred. In the tPA bolus group, the Pao 2  to Fio 2  ratio values were significantly (P < .017) higher than baseline at 6 through 168 h after randomization; the control group showed no significant improvements. Among patients receiving a tPA bolus, the percent change of Pao 2  to Fio 2  ratio at 48 h (16.9% control [interquartile range (IQR), -8.3% to 36.8%] vs 29.8% tPA bolus [IQR, 4.5%-88.7%]; P = .11), the composite outcome (11.8% vs 47.4%; P = .03), VFD (0.0 [IQR, 0.0-9.0] vs 12.0 [IQR, 0.0-19.0]; P = .11), and in-hospital mortality (41.2% vs 21.1%; P = .19) did not reach statistically significant differences when compared with those of control participants. The patients who received a tPA drip did not experience benefit.
INTERPRETATION


The combination of tPA bolus plus heparin is safe in severe COVID-19 respiratory failure. A phase 3 study is warranted given the improvements in oxygenation and promising observations in VFD and mortality.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT04357730; URL: www.clinicaltrials.gov.",2021,"In tPA-Bolus patients, the PaO2/FiO2 ratio was significantly(p<0.017) higher than baseline at 6 through 168 hours post-randomization; controls experienced no significant improvements.","['Fifty patients', 'Patients were excluded from enrollment if they did not have a neurologic exam or cross-sectional brain imaging within the previous 4.5 hours to rule out stroke and potential for hemorrhagic conversion', 'Adults with COVID-19-induced respiratory failure were randomized May14,2020-March 3,2021 in two phases: Phase-1(n=36', 'Respiratory failure in SARS-Cov2 COVID-19 (STARS']","['heparin', 'tissue-plasminogen activator(tPA', 'control vs tPA-Drip(50 mg of tPA IV-bolus, followed by tPA drip 2mg/hr plus heparin', 'Alteplase', 'tPA-Bolus+heparin', 'control (standard-of-care) vs tPA-Bolus(50mg tPA IV-bolus followed by 7 days of heparin (goal aPTT=60-80s', 'tPA']","['severe bleeding events', 'PaO2/FiO2 improvement', 'pulmonary function', 'PaO2/FiO2 improvement>50% or PaO2/FiO2>=200 at 48hrs(COMPOSITE), ventilator-free days(VFD) and mortality', 'PaO2/FiO2 ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0032140', 'cui_str': 'Plasminogen'}, {'cui': 'C0032144', 'cui_str': 'Plasminogen activator'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0452837', 'cui_str': 'Dripping'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",50.0,0.13732,"In tPA-Bolus patients, the PaO2/FiO2 ratio was significantly(p<0.017) higher than baseline at 6 through 168 hours post-randomization; controls experienced no significant improvements.","[{'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Barrett', 'Affiliation': 'Department of Surgery, Boston University School of Medicine, Boston, MA; Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; Koch Institute for Integrative Cancer Research, Center for Precision Cancer Medicine, Departments of Biological Engineering and Biology, Massachusetts Institute of Technology, Cambridge, MA.'}, {'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'Department of Surgery, University of Colorado Denver, Aurora, CO.'}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': 'Department of Surgery, University of Colorado Denver, Aurora, CO; Ernest E. Moore Shock Trauma Center at Denver Health, Department of Surgery, Denver, CO. Electronic address: ernest.moore@dhha.org.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Hajizadeh', 'Affiliation': 'Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY.'}, {'ForeName': 'Walter L', 'Initials': 'WL', 'LastName': 'Biffl', 'Affiliation': 'Division of Trauma/Acute Care Surgery, Department of Surgery, Scripps Memorial Hospital La Jolla, La Jolla, CA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lottenberg', 'Affiliation': ""Department of Surgery, St. Mary's Medical Center, Florida Atlantic University, West Palm Beach, FL.""}, {'ForeName': 'Purvesh R', 'Initials': 'PR', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Dallas, TX.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Truitt', 'Affiliation': 'Department of Surgery, Methodist Dallas Medical Center, Dallas, TX.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'McIntyre', 'Affiliation': 'Department of Surgery, University of Colorado Denver, Aurora, CO.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Bull', 'Affiliation': 'Division of Pulmonary Sciences and Critical Care Medicine, Department of Medicine, University of Colorado Denver, Aurora, CO.'}, {'ForeName': 'Lee Anne', 'Initials': 'LA', 'LastName': 'Ammons', 'Affiliation': 'Ernest E. Moore Shock Trauma Center at Denver Health, Department of Surgery, Denver, CO.'}, {'ForeName': 'Arsen', 'Initials': 'A', 'LastName': 'Ghasabyan', 'Affiliation': 'Ernest E. Moore Shock Trauma Center at Denver Health, Department of Surgery, Denver, CO.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chandler', 'Affiliation': 'Ernest E. Moore Shock Trauma Center at Denver Health, Department of Surgery, Denver, CO.'}, {'ForeName': 'Ivor S', 'Initials': 'IS', 'LastName': 'Douglas', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Schmidt', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Moore', 'Affiliation': 'Division of Pulmonary Sciences and Critical Care Medicine, Department of Medicine, University of Colorado Denver, Aurora, CO.'}, {'ForeName': 'Franklin L', 'Initials': 'FL', 'LastName': 'Wright', 'Affiliation': 'Department of Surgery, University of Colorado Denver, Aurora, CO.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Ramdeo', 'Affiliation': 'Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Borrego', 'Affiliation': 'Division of Pulmonary/Critical Care Medicine, Department of Medicine, Scripps Memorial Hospital La Jolla, La Jolla, CA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Rueda', 'Affiliation': 'Division of Pulmonary/Critical Care Medicine, Department of Medicine, Scripps Memorial Hospital La Jolla, La Jolla, CA.'}, {'ForeName': 'Achal', 'Initials': 'A', 'LastName': 'Dhupa', 'Affiliation': 'Division of Trauma/Acute Care Surgery, Department of Surgery, Scripps Memorial Hospital La Jolla, La Jolla, CA.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'McCaul', 'Affiliation': 'Division of Trauma/Acute Care Surgery, Department of Surgery, Scripps Memorial Hospital La Jolla, La Jolla, CA.'}, {'ForeName': 'Tala', 'Initials': 'T', 'LastName': 'Dandan', 'Affiliation': 'Division of Trauma/Acute Care Surgery, Department of Surgery, Scripps Memorial Hospital La Jolla, La Jolla, CA.'}, {'ForeName': 'Pralay K', 'Initials': 'PK', 'LastName': 'Sarkar', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Dallas, TX.'}, {'ForeName': 'Benazir', 'Initials': 'B', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Dallas, TX.'}, {'ForeName': 'Coimbatore', 'Initials': 'C', 'LastName': 'Sreevidya', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Dallas, TX.'}, {'ForeName': 'Conner', 'Initials': 'C', 'LastName': 'McDaniel', 'Affiliation': 'Department of Surgery, Methodist Dallas Medical Center, Dallas, TX.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Grossman Verner', 'Affiliation': 'Clinical Research Institute, Methodist Dallas Medical Center, Dallas, TX.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pearcy', 'Affiliation': 'Department of Surgery, Methodist Dallas Medical Center, Dallas, TX.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Anez-Bustillos', 'Affiliation': 'Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Elias N', 'Initials': 'EN', 'LastName': 'Baedorf-Kassis', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Rashi', 'Initials': 'R', 'LastName': 'Jhunjhunwala', 'Affiliation': 'Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Shaefi', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Capers', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Banner-Goodspeed', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Talmor', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': 'Ernest E. Moore Shock Trauma Center at Denver Health, Department of Surgery, Denver, CO; Colorado School of Public Health and Department of Surgery, University of Colorado Denver, Denver, CO.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Yaffe', 'Affiliation': 'Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; Koch Institute for Integrative Cancer Research, Center for Precision Cancer Medicine, Departments of Biological Engineering and Biology, Massachusetts Institute of Technology, Cambridge, MA.'}]",Chest,['10.1016/j.chest.2021.09.024']
1009,34597713,Archway Randomized Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration.,"PURPOSE


To evaluate the safety and efficacy of the Port Delivery System with ranibizumab (PDS) for the treatment of neovascular age-related macular degeneration (nAMD).
DESIGN


Phase 3, open-label, randomized, visual acuity assessor-masked noninferiority and equivalence trial.
PARTICIPANTS


Patients with nAMD diagnosed within 9 months of screening previously treated with and responsive to anti-vascular endothelial growth factor therapy.
METHODS


Patients were randomized 3:2 to treatment with the PDS with ranibizumab 100 mg/ml with fixed 24-week (Q24W) refill-exchanges (PDS Q24W) or intravitreal ranibizumab 0.5-mg injections every 4 weeks (monthly ranibizumab).
MAIN OUTCOME MEASURES


Primary end point was change in best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study letter (letters) score from baseline averaged over weeks 36 and 40 (noninferiority margin,-4.5 letters; equivalence margin, ±4.5 letters).
RESULTS


Archway enrolled 418 patients; 251 were randomized to and 248 received treatment with the PDS Q24W, and 167 were randomized to and received treatment with monthly ranibizumab. Baseline BCVA was 74.4 letters (PDS Q24W arm) and 75.5 letters (monthly ranibizumab arm; Snellen equivalent, 20/32). Adjusted mean change in BCVA score from baseline averaged over weeks 36 and 40 was +0.2 letters (standard error [SE], 0.5 letters) in the PDS Q24W arm and +0.5 letters (SE, 0.6 letters) in the monthly ranibizumab arm (difference, -0.3 letters; 95% confidence interval, -1.7 to 1.1 letters). PDS Q24W was both noninferior and equivalent to monthly ranibizumab. Of 246 PDS-treated patients assessed for supplemental ranibizumab treatment, 242 (98.4%) did not receive supplemental ranibizumab treatment before the first refill-exchange procedure, including 4 patients who discontinued treatment before the first refill-exchange procedure. Prespecified ocular adverse events of special interest were reported in 47 patients (19.0%) in the PDS Q24W arm and 10 patients (6.0%) in the monthly ranibizumab arm, which included, in the former arm, 4 (1.6%) endophthalmitis cases, 2 (0.8%) retinal detachments, 13 (5.2%) vitreous hemorrhages, 6 (2.4%) conjunctival erosions, and 5 (2.0%) conjunctival retractions. Most ocular adverse events in the PDS Q24W arm occurred within 1 month of implantation.
CONCLUSIONS


Archway met its primary objective and PDS Q24W demonstrated noninferior and equivalent efficacy to monthly ranibizumab, with 98.4% of PDS-treated patients not receiving supplemental treatment in the first 24-week interval.",2022,Prespecified ocular adverse events of special interest (AESIs) were reported in 47 (19.0%) PDS Q24W and 10 (6.0%) monthly ranibizumab patients.,"['Neovascular Age-Related Macular Degeneration', 'neovascular age-related macular degeneration (nAMD', 'Patients', 'Patients with nAMD diagnosed within 9 months of screening previously treated with and responsive to anti-vascular endothelial growth factor therapy', 'Archway enrolled 418 patients; 251 were randomized to and 248 received treatment with']","['ranibizumab (PDS', 'Ranibizumab', 'ranibizumab', 'supplemental ranibizumab', 'PDS with ranibizumab 100 mg/mL with fixed 24-week refill-exchanges (PDS Q24W) or intravitreal ranibizumab 0.5 mg injections every 4 weeks (monthly ranibizumab', 'PDS Q24W']","['safety and efficacy', 'Baseline BCVA', 'Ocular AESIs', 'Adjusted mean (standard error) change in BCVA score', 'vitreous hemorrhages', 'conjunctival erosions', 'Prespecified ocular adverse events of special interest (AESIs', 'change in best-corrected visual acuity (BCVA) score', 'retinal detachments']","[{'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042909', 'cui_str': 'Vitreous hemorrhage'}, {'cui': 'C0859994', 'cui_str': 'Conjunctival erosion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0035305', 'cui_str': 'Retinal detachment'}]",418.0,0.473118,Prespecified ocular adverse events of special interest (AESIs) were reported in 47 (19.0%) PDS Q24W and 10 (6.0%) monthly ranibizumab patients.,"[{'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Holekamp', 'Affiliation': 'Pepose Vision Institute, Chesterfield, Missouri. Electronic address: nholekamp@gmail.com.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Campochiaro', 'Affiliation': 'The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Chang', 'Affiliation': 'Retinal Consultants, Sacramento, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'Cincinnati Eye Institute, University of Cincinnati School of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Pieramici', 'Affiliation': 'California Retina Consultants, Santa Barbara, California.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Adamis', 'Affiliation': 'Genentech, Inc., a member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Brittain', 'Affiliation': 'Genentech, Inc., a member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Evans', 'Affiliation': 'Genentech, Inc., a member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Kaufman', 'Affiliation': 'Genentech, Inc., a member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Katie F', 'Initials': 'KF', 'LastName': 'Maass', 'Affiliation': 'Genentech, Inc., a member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Shienal', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Genentech, Inc., a member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Shrirang', 'Initials': 'S', 'LastName': 'Ranade', 'Affiliation': 'Genentech, Inc., a member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Genentech, Inc., a member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Barteselli', 'Affiliation': 'Genentech, Inc., a member of the Roche Group, South San Francisco, California.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Regillo', 'Affiliation': 'Wills Eye Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2021.09.016']
1010,34587568,Cognitive behavioral intervention for improving emotion recognition among individuals with substance use disorders: A randomized-controlled pilot study in a naturalistic setting.,"Individuals with substance use disorders (SUD) experience impaired facial emotion recognition. This pilot study explored the efficacy of a cognitive behavioral therapy (CBT) intervention to improve facial cues interpretation. Twenty-four men with SUD were randomized into an equal-size experimental and control groups and were evaluated by a cognitive-assessment battery at baseline and post-intervention. Post-intervention individuals in the experimental group recognized happy expressions with higher accuracy, and their response times were slower in sadness/disgust/neutral expressions. Interventions focused at improving social cues interpretation may facilitate social interactions and treatment outcomes for SUD population.",2021,"Post-intervention individuals in the experimental group recognized happy expressions with higher accuracy, and their response times were slower in sadness/disgust/neutral expressions.","['Individuals with substance use disorders (SUD) experience impaired facial emotion recognition', 'Twenty-four men with SUD', 'individuals with substance use disorders', 'SUD population']","['Cognitive behavioral intervention', 'cognitive behavioral therapy (CBT) intervention']","['emotion recognition', 'facial cues interpretation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}]",24.0,0.0192824,"Post-intervention individuals in the experimental group recognized happy expressions with higher accuracy, and their response times were slower in sadness/disgust/neutral expressions.","[{'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Lawental', 'Affiliation': 'School of Social Work, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'School of Social Work, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Yoav', 'Initials': 'Y', 'LastName': 'Blay', 'Affiliation': 'Child and Adolescent Division, Geha Mental Health Center, P.O. Box 102, Petah Tikva 49 100, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Shoval', 'Affiliation': 'Child and Adolescent Division, Geha Mental Health Center, P.O. Box 102, Petah Tikva 49 100, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Aviv, Israel; Princeton Neuroscience Institute, Princeton University, NJ, USA. Electronic address: shovgal@tau.ac.il.'}]",Psychiatry research,['10.1016/j.psychres.2021.114220']
1011,34587567,"Cerebellar theta burst stimulation for the treatment of negative symptoms of schizophrenia: A multicenter, double-blind, randomized controlled trial.","Given the importance of the cerebellum in the pathophysiology of schizophrenia, the cerebellar vermis has been proposed as a new rTMS stimulation site for negative symptoms. In this study, 64 patients from 7 psychiatric hospitals were randomized into the study (n=32) or control (n=32) group. Intermittent theta burst stimulation (iTBS) (or sham stimulation) to the cerebellar midline was administered 5 times/week for 2 weeks. Psychotic symptoms were assessed with the Positive and Negative Symptoms Scale (PANSS) at baseline, the end of treatment, and 2, 6, 12, and 24 weeks after the treatment. Regarding the negative symptoms, the interaction effect between group and time was statistically significant, with the scores in the study group significantly lower than those in the control group at the 4 follow-ups after treatment, and the group difference was maximal at 24 weeks of follow-up. The main effect of time was significant; however, the main effect of group did not show statistical significance. Our study revealed that cerebellar iTBS may improve negative symptoms in schizophrenia patients, and the effect was more pronounced at 24 weeks after the end of treatment, which provides preliminary empirical evidence for the maintenance of efficacy after stimulation of this new site.",2021,"Regarding the negative symptoms, the interaction effect between group and time was statistically significant, with the scores in the study group significantly lower than those in the control group at the 4 follow-ups after treatment, and the group difference was maximal at 24 weeks of follow-up.","['schizophrenia patients', '64 patients from 7 psychiatric hospitals were randomized into the study (n=32) or control (n=32) group', 'negative symptoms of schizophrenia']","['Intermittent theta burst stimulation (iTBS) (or sham stimulation', 'Cerebellar theta burst stimulation']","['negative symptoms', 'Positive and Negative Symptoms Scale (PANSS', 'Psychotic symptoms']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}]",64.0,0.0893103,"Regarding the negative symptoms, the interaction effect between group and time was statistically significant, with the scores in the study group significantly lower than those in the control group at the 4 follow-ups after treatment, and the group difference was maximal at 24 weeks of follow-up.","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Center for Mental Disease Control and Prevention, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.'}, {'ForeName': 'Weibo', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Center for Mental Disease Control and Prevention, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.'}, {'ForeName': 'Youwei', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Center for Mental Disease Control and Prevention, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Mu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Center for Mental Disease Control and Prevention, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Tongji Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Yanfeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Center for Mental Disease Control and Prevention, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Center for Mental Disease Control and Prevention, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China. Electronic address: caijun533@163.com.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xie', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Center for Mental Disease Control and Prevention, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China. Electronic address: xiebin313@126.com.'}]",Psychiatry research,['10.1016/j.psychres.2021.114204']
1012,34597436,Low-dose ketamine infusion in treatment-resistant double depression: Revisiting the adjunctive ketamine study of Taiwanese patients with treatment-resistant depression.,"BACKGROUND


Whether a single low-dose ketamine infusion may have rapid antidepressant and antisuicidal effects in patients with treatment-resistant double depression remains unclear.
METHODS


This study enrolled 35 patients with treatment-resistant double depression, 12 of whom received 0.5 mg/kg ketamine, 11 received 0.2 mg/kg ketamine, and 12 received normal saline as a placebo. The patients were assessed using the 17-item Hamilton Rating Scale for Depression (HDRS) prior to the initiation of infusions, at 40 and 240 min post-infusion, and sequentially on Days 2-7 and on Day 14 after ketamine or placebo infusions.
RESULTS


A single 0.5 mg/kg ketamine infusion had rapid antidepressant (p = 0.031, measured by the HDRS) and antisuicidal (p = 0.033, measured by the HDRS item 3 scores) effects in patients with treatment-resistant double depression. However, 0.2 mg/kg ketamine was insufficient to exert rapid antidepressant and antisuicidal effects in this patient population with severe and chronic illness.
DISCUSSION


In this patient population, the commonly used dose of 0.5 mg/kg was sufficient. Additional studies are required to investigate whether repeated infusions of low-dose ketamine may also maintain antidepressant and antisuicidal effects in patients with treatment-resistant double depression.",2022,"A single 0.5 mg/kg ketamine infusion had rapid antidepressant (p = 0.031, measured by the HDRS) and antisuicidal (p = 0.033, measured by the HDRS item 3 scores) effects in patients with treatment-resistant double depression.","['treatment-resistant double depression', 'patients with treatment-resistant double depression remains unclear', 'Taiwanese patients with treatment-resistant depression', 'patient population with severe and chronic illness', 'patients with treatment-resistant double depression', '35 patients with treatment-resistant double depression, 12 of whom received 0.5\xa0mg/kg']","['ketamine or placebo infusions', 'ketamine, 11 received 0.2\xa0mg/kg ketamine', 'ketamine', 'normal saline as a placebo']",['17-item Hamilton Rating Scale for Depression (HDRS'],"[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",35.0,0.199172,"A single 0.5 mg/kg ketamine infusion had rapid antidepressant (p = 0.031, measured by the HDRS) and antisuicidal (p = 0.033, measured by the HDRS item 3 scores) effects in patients with treatment-resistant double depression.","[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Hui-Ju', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Wei-Chung', 'Initials': 'WC', 'LastName': 'Mao', 'Affiliation': 'Department of Psychiatry, Cheng Hsin General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}]",Human psychopharmacology,['10.1002/hup.2820']
1013,34599693,Acute effects of whole body vibration exercise on post-load glucose metabolism in healthy men: a pilot randomized crossover trial.,"PURPOSE


Exercise on a whole body vibration (WBV) platform, namely WBV exercise (WBVE), has long-term beneficial effects on glucose metabolism, similarly to conventional moderate-intensity exercise. Conventional moderate-intensity exercise reduces post-load plasma glucose levels at the acute phase. This study aimed to reveal acute effects of WBVE on post-load glucose metabolism.
METHODS


This randomized crossover trial enrolled 18 healthy men. They completed the following three interventions in a random order: (1) a 2-hour 75-g oral glucose tolerance test (OGTT) without WBVE (OGTT-alone), (2) 20-minute WBVE before an OGTT (WBVE → OGTT), and (3) 20-minute WBVE during an OGTT (OGTT → WBVE). Post-load glucose metabolism in the WBVE → OGTT and OGTT → WBVE interventions were compared with that in the OGTT-alone intervention.
RESULTS


Plasma glucose levels in the WBVE → OGTT and OGTT → WBVE interventions were not significantly different from those in the OGTT-alone intervention at any time point except 15 min, wherein the WBVE → OGTT intervention had higher glucose levels (111 [interquartile range, 102-122] mg/dL vs 122 [111-134] mg/dL, P = 0.026). Higher plasma glucagon levels were observed at 0 min in the WBVE → OGTT intervention and at 60 min in the OGTT → WBVE intervention (P = 0.010 and 0.015). Cortisol, Growth hormone, and adrenaline levels were significantly increased after WBVE, whereas noradrenaline levels were not. Serum insulin levels in the WBVE → OGTT intervention were significantly higher than those in the OGTT-alone intervention at 0 min (P = 0.008).
CONCLUSIONS


WBVE did not decrease post-load plasma glucose levels at the acute phase. Acute effects of WBVE on post-load glucose metabolism would not be identical to those of conventional exercise. The unique trial number and the name of the registry: UMIN000036520, www.umin.ac.jp , date of registration, June 12, 2019.",2022,"Serum insulin levels in the WBVE → OGTT intervention were significantly higher than those in the OGTT-alone intervention at 0 min (P = 0.008).
","['healthy men', '18 healthy men']","['whole body vibration exercise', 'whole body vibration (WBV) platform, namely WBV exercise (WBVE', '2-hour 75-g oral glucose tolerance test (OGTT) without WBVE (OGTT-alone), (2) 20-minute WBVE before an OGTT (WBVE\u2009→\u2009OGTT', 'WBVE', 'Conventional moderate-intensity exercise']","['Serum insulin levels', 'Plasma glucose levels', 'Cortisol, Growth hormone, and adrenaline levels', 'post-load plasma glucose levels', 'glucose levels', 'Higher plasma glucagon levels', 'noradrenaline levels']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0201998', 'cui_str': 'Epinephrine measurement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]",18.0,0.0211122,"Serum insulin levels in the WBVE → OGTT intervention were significantly higher than those in the OGTT-alone intervention at 0 min (P = 0.008).
","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watanabe', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Takahara', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. takahara@endmet.med.osaka-u.ac.jp.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Katakami', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kanamoto', 'Affiliation': 'Department of Health and Sport Sciences, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Nakata', 'Affiliation': 'Department of Health and Sport Sciences, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Iichiro', 'Initials': 'I', 'LastName': 'Shimomura', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}]",Endocrine,['10.1007/s12020-021-02893-w']
1014,34599476,Effect of a Behavioural Intervention for Adoption and Maintenance of a Physically Active Lifestyle on Psychological Well-Being and Quality of Life in Patients with Type 2 Diabetes: The IDES_2 Randomized Clinical Trial.,"BACKGROUND


Psychological well-being and quality of life (QoL) are important outcomes of lifestyle interventions, as a positive impact may favour long-term maintenance of behaviour change.
OBJECTIVE


This study investigated the effect of a behavioural intervention for adopting and maintaining an active lifestyle on psychological well-being and health-related QoL in individuals with type 2 diabetes.
METHODS


Three hundred physically inactive and sedentary patients were randomized 1:1 to receive 1 month's theoretical and practical counselling once a year (intervention group, INT) or standard care (control group, CON) for 3 years. Psychological well-being and QoL, assessed using the World Health Organization (WHO)-5 and the 36-Item Short Form (SF-36) questionnaire, respectively, were pre-specified secondary endpoints. The primary endpoint was sustained behaviour change, as assessed by accelerometer-based measurement of physical activity (PA) and sedentary time.
RESULTS


WHO-5 and SF-36 physical and mental component summary (PCS and MCS) scores increased progressively in the INT group and decreased in the CON group, resulting in significant between-group differences (WHO-5: mean difference 7.35 (95% confidence interval (CI) 3.15-11.55), P = 0.0007; PCS 4.20 (95% CI 2.25-6.15), P < 0.0001; MCS 3.04 (95% CI 1.09-4.99), P = 0.0025). Percentage of participants with likely depression decreased in the INT group and increased in the CON group. PA volume changes were independently associated with WHO-5 changes, which were significantly higher in participants who accumulated > 150 min·wk -1  of moderate-to-vigorous intensity PA versus those who did not (13.06 (95% CI 7.51-18.61), P < 0.0001), whereas no relationship was detected for QoL.
CONCLUSION


A counselling intervention that was effective in promoting a sustained change in PA and sedentary behaviour significantly improved psychological well-being and QoL.
TRIAL REGISTRATION


ClinicalTrials.gov; NCT01600937; 10 October 2012.",2022,"PA volume changes were independently associated with WHO-5 changes, which were significantly higher in participants who accumulated > 150 ","['Three hundred physically inactive and sedentary patients', 'individuals with type 2 diabetes', 'participants who accumulated\u2009>\u2009150', 'Patients with Type 2 Diabetes']","['CON', ""1\xa0month's theoretical and practical counselling once a year (intervention group, INT) or standard care (control group, CON"", 'Behavioural Intervention', 'behavioural intervention']","['WHO-5 and SF-36 physical and mental component summary (PCS and MCS', 'PA volume changes', 'Psychological well-being and QoL, assessed using the World Health Organization (WHO)-5 and the 36-Item Short Form (SF-36) questionnaire', 'likely depression', 'sustained behaviour change, as assessed by accelerometer-based measurement of physical activity (PA) and sedentary time', 'Psychological Well-Being and Quality of Life']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",300.0,0.125237,"PA volume changes were independently associated with WHO-5 changes, which were significantly higher in participants who accumulated > 150 ","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nicolucci', 'Affiliation': 'Centre for Outcomes Research and Clinical Epidemiology (CORESEARCH), Pescara, Italy.'}, {'ForeName': 'Jonida', 'Initials': 'J', 'LastName': 'Haxhi', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': ""D'Errico"", 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Sacchetti', 'Affiliation': ""Department of Human Movement and Sport Sciences, University of Rome 'Foro Italico', Rome, Italy.""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Orlando', 'Affiliation': ""Department of Human Movement and Sport Sciences, University of Rome 'Foro Italico', Rome, Italy.""}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Cardelli', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.'}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Bollanti', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Conti', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.'}, {'ForeName': 'Silvano', 'Initials': 'S', 'LastName': 'Zanuso', 'Affiliation': 'Centre for Applied Biological and Exercise Sciences, Faculty of Health and Life Sciences, Coventry University, Coventry, UK.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lucisano', 'Affiliation': 'Centre for Outcomes Research and Clinical Epidemiology (CORESEARCH), Pescara, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Balducci', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Via di Grottarossa, 1035-1039, 00189, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pugliese', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome La Sapienza, Via di Grottarossa, 1035-1039, 00189, Rome, Italy. giuseppe.pugliese@uniroma1.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Sports medicine (Auckland, N.Z.)",['10.1007/s40279-021-01556-0']
1015,34601602,Continuous Pecto-Intercostal Fascial Block Provides Effective Analgesia in Patients Undergoing Open Cardiac Surgery: A Randomized Controlled Trial.,"BACKGROUND


The optimal analgesia regimen after open cardiac surgery has been unclear. The aim of this study was to investigate the beneficial effects of continuous pecto-intercostal fascial blocks (PIFB) initiated before surgery on outcomes after open cardiac surgery.
METHODS


A group of 116 patients were randomly allocated to receive either bilateral continuous PIFB (PIF group) or the same block with saline (SAL group). The primary endpoint was postoperative pain at 4, 8, 16, 24, 48, and 72 hours after extubation at rest and during exercise. The secondary outcome measures included analgesia requirements (sufentanil and flurbiprofen consumption), time to extubation, length of stay in the intensive care unit, incidence of postoperative nausea and vomiting, time until return of bowel function, time to mobilization, time to urinary catheter removal, and the length of hospital stay.
RESULTS


The length of stay in the intensive care unit (29 ± 7 hours vs 13 ± 4 hours, P < 0.01) and length of hospital stay (8.9 ± 0.9 days vs 6.5 ± 1.1 days, P < 0.01) were significantly longer in the SAL group than in the PIF group. Resting pain scores (2 hours after extubation: 1.1 vs 3.3, P < 0.01; 4 hours after extubation: 1.0 vs 3.5, P < 0.01; 8 hours after extubation: 1.2 vs 3.7, P < 0.01; 16 hours after extubation: 1.3 vs 3.7, P < 0.01; 24 hours after extubation: 1.4 vs 2.8, P < 0.01; 48 hours after extubation: 0.9 vs 2.2, P < 0.01; 72 hours after extubation: 0.8 vs 2.1, P < 0.01) and dynamic pain scores (2 hours after extubation: 1.4 vs 3.7, P < 0.01; 4 hours after extubation: 1.3 vs 3.8, P < 0.01; 8 hours after extubation: 1.4 vs 3.5, P < 0.01; 16 hours after extubation: 1.2 vs 3.4, P < 0.01; 24 hours after extubation: 1.1 vs 3.1, P < 0.01; 48 hours after extubation: 1.0 vs 2.9, P < 0.01; 72 hours after extubation: 0.9 vs 2.8, P < 0.01) were significantly lower in the PIF group than in the SAL group at all time points. The PIF group required significantly less intraoperative sufentanil consumption (123 ± 32 μg vs 63 ± 16 μg, P < 0.01), postoperative sufentanil consumption (102 ± 22 μg vs 52 ± 17 μg, P < 0.01), and postoperative flurbiprofen consumption (350 ± 100 mg vs 100 ± 100 mg, P < 0.01) than the SAL groups. Time to extubation (8.9 ± 2.4 hours vs 3.2 ± 1.3 hours, P < 0.01), time to first flatus (43 ± 6 hours vs 30 ± 7 hours, P < 0.01), time until mobilization (35 ± 5 hours vs 24 ± 7 hours, P < 0.01), and time until urinary catheter removal (47 ± 9 hours vs 31 ± 4 hours, P < 0.01) were significantly earlier in the PIF group than in the SAL group. The incidence of postoperative nausea and vomiting was significantly lower in the PIF group (9.1% vs 27.3%, P < 0.01).
CONCLUSION


Bilateral continuous PIFB reduced the length of hospital stay and provided effective postoperative pain relief for 3 days.",2022,"Resting pain scores (2 h after extubation : 1.1 vs 3.3, p < 0.01; 4 h after extubation : 1.0 vs 3.5, p < 0.01; 8 h after extubation : 1.2 vs 3.7, p < 0.01; 16 h after extubation : 1.3 vs 3.7, p < 0.01; 24 h after extubation : 1.4 vs 2.8, p < 0.01; 48 h after extubation : 0.9 vs 2.2, p < 0.01; 72 h after extubation : 0.8 vs 2.1, p < 0.01) and dynamic pain scores (2 h after extubation : 1.4 vs 3.7, p < 0.01; 4 h after extubation : 1.3 vs 3.8, p < 0.01; 8 h after extubation : 1.4 vs 3.5, p < 0.01; 16 h after extubation : 1.2 vs 3.4, p < 0.01; 24 h after extubation : 1.1 vs 3.1, p < 0.01; 48 h after extubation : 1.0 vs 2.9, p < 0.01; 72 h after extubation: 0.9 vs 2.8, p < 0.01) were significantly lower in PIF group compared with SAL group at all time points.","['Patients Undergoing Open Cardiac Surgery', 'A group of 116 patients']","['bilateral continuous PIFB (PIF group) or the same block with saline (SAL', 'Continuous Pecto-Intercostal Fascial Block', 'continuous Pecto-Intercostal Fascial Block (PIFB) blocks', 'SAL']","['Time to extubation', 'analgesia requirements (sufentanil and flurbiprofen consumption), time to extubation, length of stay in the ICU, incidence of postoperative nausea and vomiting (PONV), time until return of bowel function, time to mobilization, urinary catheter removal and the length of hospital stay', 'postoperative pain', 'time to first flatus', 'length of stay in the ICU', 'postoperative sufentanil', 'dynamic pain scores', 'Resting pain scores', 'time until mobilization', 'time until urinary catheter removal', 'incidence of PONV', 'consumption, postoperative flurbiprofen consumption', 'length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0033373', 'cui_str': 'Prolactin inhibiting factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0016377', 'cui_str': 'Flurbiprofen'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",116.0,0.0712047,"Resting pain scores (2 h after extubation : 1.1 vs 3.3, p < 0.01; 4 h after extubation : 1.0 vs 3.5, p < 0.01; 8 h after extubation : 1.2 vs 3.7, p < 0.01; 16 h after extubation : 1.3 vs 3.7, p < 0.01; 24 h after extubation : 1.4 vs 2.8, p < 0.01; 48 h after extubation : 0.9 vs 2.2, p < 0.01; 72 h after extubation : 0.8 vs 2.1, p < 0.01) and dynamic pain scores (2 h after extubation : 1.4 vs 3.7, p < 0.01; 4 h after extubation : 1.3 vs 3.8, p < 0.01; 8 h after extubation : 1.4 vs 3.5, p < 0.01; 16 h after extubation : 1.2 vs 3.4, p < 0.01; 24 h after extubation : 1.1 vs 3.1, p < 0.01; 48 h after extubation : 1.0 vs 2.9, p < 0.01; 72 h after extubation: 0.9 vs 2.8, p < 0.01) were significantly lower in PIF group compared with SAL group at all time points.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Shibiao', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnab291']
1016,34617561,"Fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs), but not gluten, elicit modest symptoms of irritable bowel syndrome: a double-blind, placebo-controlled, randomized three-way crossover trial.","BACKGROUND


Irritable bowel syndrome (IBS) has been associated with diets rich in fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs), and gluten. Most previous studies have been single-blind and have focused on the elimination of FODMAPs or provocation with single FODMAPs. The effect of gluten is unclear, large trials isolating the effect of gluten from that of FODMAPs are needed.
OBJECTIVES


The aims of this study were to ensure high intakes of a wide range of FODMAPs, gluten, or placebo, and to evaluate the effects on IBS symptoms using the IBS-severity scoring system (IBS-SSS).
METHODS


The study was carried out with a double-blind, placebo-controlled, randomized 3-way crossover design in a clinical facility in Uppsala from September 2018 to June 2019. In all, 110 participants fulfilling the IBS Rome IV criteria, with moderate to severe IBS, were randomly assigned; 103 (90 female, 13 male) completed the trial. Throughout, IBS participants maintained a diet with minimal FODMAP content and no gluten. Participants were block-randomly assigned to 1-wk interventions with FODMAPs (50 g/d), gluten (17.3 g/d), or placebo, separated by 1-wk washout. All participants who completed ≥1 intervention were included in the intention-to-treat analysis.
RESULTS


In participants with IBS (n = 103), FODMAPs caused higher IBS-SSS scores (mean 240 [95% CI: 222, 257]) than placebo (198 [180, 215]; P = 0.00056) or gluten (208 [190, 226]; P = 0.013); no differences were found between the placebo and gluten groups (P = 1.0). There were large interindividual differences in IBS-SSS scores associated with treatment. No adverse events were reported.
CONCLUSION


In participants with IBS, FODMAPs had a modest effect on typical IBS symptoms, whereas gluten had no effect. The large interindividual differences in responses to the interventions warrant further detailed studies to identify possible underlying causes and enable individual prediction of responses. This trial was registered at www.clinicaltrials.gov as NCT03653689.",2022,P = 0.013); no differences were found between the placebo and gluten groups (P = 1.0).,"['110 participants fulfilling the IBS Rome IV criteria, with moderate to severe IBS, were randomized; 103 (90 female, 13 male) completed the trial', 'All participants who completed at least one intervention were included in the intention-to-treat analysis', 'Irritable bowel syndrome (IBS', 'clinical facility in Uppsala in September 2018-June 2019']","['placebo', 'FODMAPs']","['irritable bowel syndrome', 'IBS-SSS scores', 'typical IBS symptoms', 'adverse events']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028953', 'cui_str': 'Oligonucleotide'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0071629', 'cui_str': 'polyol'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",110.0,0.484346,P = 0.013); no differences were found between the placebo and gluten groups (P = 1.0).,"[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Nordin', 'Affiliation': 'Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Brunius', 'Affiliation': 'Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Landberg', 'Affiliation': 'Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Per M', 'Initials': 'PM', 'LastName': 'Hellström', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab337']
1017,34605392,Daily associations between modifiable sleep behaviors and nighttime sleep among young adult drinkers with insomnia.,"STUDY OBJECTIVES


Empirical evidence linking individual sleep hygiene practices to subsequent sleep parameters is limited, particularly at the daily level. This study compared the strength of daily, within-person associations between these modifiable sleep behaviors and nighttime sleep in young adult drinkers with insomnia.
METHODS


Young adults (ages 18-30 years; n = 56) who met diagnostic criteria for insomnia and reported past-month binge drinking wore wrist actigraphy and completed online sleep diaries for 8.5 days (standard deviation = 2.3; 477 reports). Diaries assessed engagement in 11 sleep hygiene recommendations. Multilevel models tested daily associations between sleep behaviors and 3 outcomes: sleep quality, self-reported sleep efficiency, and actigraphy-measured sleep efficiency.
RESULTS


Participants self-reported better sleep quality/efficiency on days that they slept in a comfortable environment, limited naps to 30 minutes, and maintained a consistent wake time. They self-reported worse sleep quality and efficiency on nights that they avoided alcohol use before bedtime. No sleep behaviors were significantly associated with actigraphy-measured sleep efficiency after correcting for inflation in type I error.
CONCLUSIONS


The sleep hygiene recommendations most strongly associated with sleep at the daily level were consistent with stimulus control. Creating a comfortable sleep environment also emerged as an important correlate of daily sleep. Heavy drinkers with insomnia may perceive better sleep if they drink before bedtime; however, this finding may be unique to this population.
CITATION


Miller MB, Curtis AF, Hall NA, et al. Daily associations between modifiable sleep behaviors and nighttime sleep among young adult drinkers with insomnia.  J Clin Sleep Med.  2022;18(3):703-712.",2022,"No sleep behaviors were significantly associated with actigraphy-measured sleep efficiency after correcting for inflation in Type I error.
","['Heavy drinkers with insomnia', 'Young adults (18-30y,  N =56) who met diagnostic criteria for insomnia and reported past-month binge drinking wore wrist actigraphy and completed online sleep diaries for 8.5 days ( SD =2.3; 477 reports', 'young adult drinkers with insomnia']",[],"['nighttime sleep', 'sleep behaviors and three outcomes: sleep quality, self-reported sleep efficiency, and actigraphy-measured sleep efficiency', 'sleep quality/efficiency', 'sleep behaviors', 'sleep efficiency', 'sleep quality and efficiency']","[{'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],"[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0945351,"No sleep behaviors were significantly associated with actigraphy-measured sleep efficiency after correcting for inflation in Type I error.
","[{'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Ashley F', 'Initials': 'AF', 'LastName': 'Curtis', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Hall', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Lindsey K', 'Initials': 'LK', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Everson', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Leticia D', 'Initials': 'LD', 'LastName': 'Martinez', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Chan Jeong', 'Initials': 'CJ', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'McCrae', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, Missouri.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9706']
1018,34608858,Validation of a nonwearable device in healthy adults with normal and short sleep durations.,"STUDY OBJECTIVES


To determine the accuracy of early and newer versions of a nonwearable sleep tracking device relative to polysomnography and actigraphy, under conditions of normal and restricted sleep duration.
METHODS


Participants were 35 healthy adults (mean age = 18.97; standard deviation = 0.95 years; 77.14% female; 42.86% White). In a controlled sleep laboratory environment, we randomly assigned participants to go to bed at 10:30 pm (normal sleep) or 1:30 am (restricted sleep), setting lights-on at 7:00 am. Sleep was measured using polysomnography, wristband actigraphy (the Philips Respironics Actiwatch Spectrum Plus), self-report, and an early or newer version of a nonwearable device that uses a sensor strip to measure movement, heart rate, and breathing (the Apple, Inc. Beddit). We tested accuracy against polysomnography for total sleep time, sleep efficiency, sleep onset latency, and wake after sleep onset.
RESULTS


The early version of the nonwearable device (Beddit 3.0) displayed poor reliability (intraclass correlation coefficient [ICC] < 0.30). However, the newer nonwearable device (Beddit 3.5) yielded excellent reliability with polysomnography for total sleep time (ICC = 0.998) and sleep efficiency (ICC = 0.98) across normal and restricted sleep conditions. Agreement was also excellent for the notoriously difficult metrics of sleep onset latency (ICC = 0.92) and wake after sleep onset (ICC = 0.92). This nonwearable device significantly outperformed clinical-grade actigraphy (ICC between 0.44 and 0.96) and self-reported sleep measures (ICC < 0.75).
CONCLUSIONS


A nonwearable device showed better agreement than actigraphy with polysomnography outcome measures. Future work is needed to test the validity of this device in clinical populations.
CITATION


Hsiou DA, Gao C, Matlock RC, Scullin MK. Validation of a nonwearable device in healthy adults with normal and short sleep durations.  J Clin Sleep Med.  2022;18(3):751-757.",2022,"This non-wearable device significantly outperformed clinical grade actigraphy (ICCs between 0.44 and 0.96) and self-reported sleep measures (ICCs below 0.75).
","['healthy adults with normal and short sleep durations', 'Participants were 35 healthy adults (M age =18.97, SD=0.95 years; 77.14% female; 42.86% Caucasian']","['go to bed at 10:30pm (normal sleep) or 1:30am (restricted sleep), setting lights-on at 7:00am']","['total sleep time (TST), sleep efficiency (SE%), sleep onset latency (SOL), and wake after sleep onset (WASO', 'Sleep']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",35.0,0.0933656,"This non-wearable device significantly outperformed clinical grade actigraphy (ICCs between 0.44 and 0.96) and self-reported sleep measures (ICCs below 0.75).
","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hsiou', 'Affiliation': 'Department of Psychology and Neuroscience, Baylor University, Waco, Texas.'}, {'ForeName': 'Chenlu', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Matlock', 'Affiliation': 'Ascension Medical Group Providence, Department of Sleep Medicine, Waco, Texas.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Scullin', 'Affiliation': 'Department of Psychology and Neuroscience, Baylor University, Waco, Texas.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9700']
1019,33463408,"Gender Norms, Beliefs and Academic Achievement of Orphaned Adolescent Boys and Girls in Uganda.","This study examined the traditional gender norms and beliefs held by orphaned adolescent boys and girls, and the role of such norms and beliefs on their academic performance. Data from a NIMH-funded study known as Suubi-Maka in Uganda were analyzed. Results indicate that overall, adolescents held strong gendered norms and beliefs that favor males over females. Compared to boys, girls were more likely to report more egalitarian gender norms and beliefs that give equal consideration to both girls and boys. In addition, more egalitarian gender norms and beliefs were associated with better school grades. Study findings point to the need to integrate targeted components that address harmful gender norms and beliefs in programs that support vulnerable adolescents, including education policy, if we are to address inequalities in education access and achievement, as well promote and strengthen education for all in sub-Saharan Africa.",2021,"Compared to boys, girls were more likely to report more egalitarian gender norms and beliefs that give equal consideration to both girls and boys.",['Orphaned Adolescent Boys and Girls in Uganda'],[],"['Gender Norms, Beliefs and Academic Achievement']","[{'cui': 'C0242299', 'cui_str': 'Orphan'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]",[],"[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}]",,0.104573,"Compared to boys, girls were more likely to report more egalitarian gender norms and beliefs that give equal consideration to both girls and boys.","[{'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School of Social Work, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Jami', 'Initials': 'J', 'LastName': 'Curley', 'Affiliation': 'School of Social Work, Saint Louis University, St. Louis, Missouri, USA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School of Social Work, Washington University in St. Louis, St. Louis, Missouri, USA.'}]",The Journal of genetic psychology,['10.1080/00221325.2021.1873727']
1020,34612846,Prognostic and Predictive Biomarkers in Patients With Coronavirus Disease 2019 Treated With Tocilizumab in a Randomized Controlled Trial.,"OBJECTIVES


To explore candidate prognostic and predictive biomarkers identified in retrospective observational studies (interleukin-6, C-reactive protein, lactate dehydrogenase, ferritin, lymphocytes, monocytes, neutrophils, d-dimer, and platelets) in patients with coronavirus disease 2019 pneumonia after treatment with tocilizumab, an anti-interleukin-6 receptor antibody, using data from the COVACTA trial in patients hospitalized with severe coronavirus disease 2019 pneumonia.
DESIGN


Exploratory analysis from a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial.
SETTING


Hospitals in North America and Europe.
PATIENTS


Adults hospitalized with severe coronavirus disease 2019 pneumonia receiving standard care.
INTERVENTION


Randomly assigned 2:1 to IV tocilizumab 8 mg/kg or placebo.
MEASUREMENTS AND MAIN RESULTS


Candidate biomarkers were measured in 295 patients in the tocilizumab arm and 142 patients in the placebo arm. Efficacy outcomes assessed were clinical status on a seven-category ordinal scale (1, discharge; 7, death), mortality, time to hospital discharge, and mechanical ventilation (if not receiving it at randomization) through day 28. Prognostic and predictive biomarkers were evaluated continuously with proportional odds, binomial or Fine-Gray models, and additional sensitivity analyses. Modeling in the placebo arm showed all candidate biomarkers except lactate dehydrogenase and d-dimer were strongly prognostic for day 28 clinical outcomes of mortality, mechanical ventilation, clinical status, and time to hospital discharge. Modeling in the tocilizumab arm showed a predictive value of ferritin for day 28 clinical outcomes of mortality (predictive interaction, p = 0.03), mechanical ventilation (predictive interaction, p = 0.01), and clinical status (predictive interaction, p = 0.02) compared with placebo.
CONCLUSIONS


Multiple biomarkers prognostic for clinical outcomes were confirmed in COVACTA. Ferritin was identified as a predictive biomarker for the effects of tocilizumab in the COVACTA patient population; high ferritin levels were associated with better clinical outcomes for tocilizumab compared with placebo at day 28.",2022,Ferritin was identified as a predictive biomarker for the effects of tocilizumab in the COVACTA patient population; high ferritin levels were associated with better clinical outcomes for tocilizumab compared with placebo at day 28.,"['patients hospitalized with severe coronavirus disease 2019 pneumonia', 'Patients With Coronavirus Disease 2019 Treated With', 'patients with coronavirus disease 2019 pneumonia after treatment with', 'Hospitals in North America and Europe', '295 patients in the tocilizumab arm and 142 patients in the placebo arm', 'Adults hospitalized with severe coronavirus disease 2019 pneumonia receiving standard care']","['tocilizumab', 'placebo', 'tocilizumab 8\u2009mg/kg or placebo', 'Tocilizumab']","['mortality, mechanical ventilation, clinical status, and time to hospital discharge', 'clinical status on a seven-category ordinal scale (1, discharge; 7, death), mortality, time to hospital discharge, and mechanical ventilation (if not receiving it at randomization', 'mechanical ventilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",,0.52405,Ferritin was identified as a predictive biomarker for the effects of tocilizumab in the COVACTA patient population; high ferritin levels were associated with better clinical outcomes for tocilizumab compared with placebo at day 28.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Tom', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Bao', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Tsai', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Qamra', 'Affiliation': 'Hoffmann-La Roche Ltd, Mississauga, ON, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Summers', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Carrasco-Triguero', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'McBride', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Carrie M', 'Initials': 'CM', 'LastName': 'Rosenberger', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Celia J F', 'Initials': 'CJF', 'LastName': 'Lin', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Stubbings', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Blyth', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Carratalà', 'Affiliation': 'Department of Infectious Diseases, Bellvitge University Hospital, Bellvitge Biomedical Research Institute, University of Barcelona and Spanish Network for Research in Infectious Diseases, Barcelona, Spain.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'François', 'Affiliation': 'Intensive Care Unit and Inserm CIC1435 and UMR1092, CHU Limoges, Limoges, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Center of Research and Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital, Amager Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Haslem', 'Affiliation': 'Medical Oncology, Intermountain Medical Group, St George, UT.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bonfanti', 'Affiliation': 'School of Medicine and Surgery, University of Milano-Bicocca and Infectious Diseases Unit Azienda Ospedaliera San Gerardo di Monza, Monza, Italy.'}, {'ForeName': 'Cor H', 'Initials': 'CH', 'LastName': 'van der Leest', 'Affiliation': 'Pulmonary Surgery, Amphia Ziekenhuis, Breda, The Netherlands.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Rohatgi', 'Affiliation': 'Division of Hospital Medicine, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Wiese', 'Affiliation': 'Department of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Charles Edouard', 'Initials': 'CE', 'LastName': 'Luyt', 'Affiliation': 'Service de Réanimation, Institut de Cardiologie, Hopital de la Pitié Salpêtrière, Paris, France.'}, {'ForeName': 'Farrah', 'Initials': 'F', 'LastName': 'Kheradmand', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Ivan O', 'Initials': 'IO', 'LastName': 'Rosas', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Cai', 'Affiliation': 'Genentech, South San Francisco, CA.'}]",Critical care medicine,['10.1097/CCM.0000000000005229']
1021,34606988,Integrating tobacco treatment into lung cancer screening practices: Study protocol for the Screen ASSIST randomized clinical trial.,"BACKGROUND


Integrating tobacco treatment services into lung cancer screening (LCS) has the potential to leverage a 'teachable moment' to promote cessation among long-term smokers and reduce disparities in tobacco treatment access. This protocol paper describes the Screen ASSIST (Aiding Screening Support In Stopping Tobacco) trial, which will identify how to best deliver evidence-driven tobacco treatment in the context of LCS.
METHODS


Screen ASSIST is a randomized clinical trial with a 3-factor, fully crossed factorial design that enrolls current smokers (any cigarette use in the past 30 days) scheduled to attend LCS at multiple sites in the Mass General Brigham healthcare system. To maximize reach, recruitment is conducted at 3 time points: 1) at the time of LCS scheduling, 2) at the LCS visit, and 3) after the participant has received their LCS results. Participants are stratified by LCS study site and recruitment point and randomly assigned into 8 groups that test intervention components varying on telehealth counseling duration (4 weeks vs. 8 weeks), nicotine replacement therapy duration (2 weeks vs. 8 weeks), and systematic screening and referral for social determinants of health via a service named 'AuntBertha' (referral vs. no referral). The primary study outcome is self-reported past 7-day tobacco abstinence at 6-month follow-up. This trial will also assess systems integration and evaluate implementation of the intervention.
DISCUSSION


Screen ASSIST will identify the most effective combination of tobacco cessation treatments within the LCS context, in order to improve the cost-effectiveness of LCS and quality of life among long-term heavy smokers.",2021,"This protocol paper describes the Screen ASSIST (Aiding Screening Support in Stopping Tobacco) trial, which will identify how to best deliver evidence-driven tobacco treatment in the context of LCS.
","['enrolls current smokers (any cigarette use in the past 30\u202fdays) scheduled to attend LCS at multiple sites in the Mass General Brigham healthcare system', 'lung cancer screening practices']","[""nicotine replacement therapy duration (2\u202fweeks vs. 8\u202fweeks), and systematic screening and referral for social determinants of health via a service named 'AuntBertha' (referral vs. no referral"", 'test intervention components varying on telehealth counseling duration']","['self-reported past 7-day tobacco abstinence', 'cost-effectiveness of LCS and quality of life']","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C3658315', 'cui_str': 'Social Determinants of Health'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.215881,"This protocol paper describes the Screen ASSIST (Aiding Screening Support in Stopping Tobacco) trial, which will identify how to best deliver evidence-driven tobacco treatment in the context of LCS.
","[{'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Neil', 'Affiliation': 'Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States of America; TSET Health Promotion Research Center, Stephenson Cancer Center, Oklahoma City, OK, United States of America; Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America. Electronic address: Jordan-Neil@ouhsc.edu.'}, {'ForeName': 'Caylin', 'Initials': 'C', 'LastName': 'Marotta', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Gonzalez', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Levy', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Tobacco Research and Treatment Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wint', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Harris', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Saif', 'Initials': 'S', 'LastName': 'Hawari', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Noonan', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Styklunas', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Crute', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Sydney E', 'Initials': 'SE', 'LastName': 'Howard', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Sheppard', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Inga T', 'Initials': 'IT', 'LastName': 'Lennes', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Jacobson', 'Affiliation': ""Department of Radiology, Brigham and Women's Faulkner Hospital, Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Efren J', 'Initials': 'EJ', 'LastName': 'Flores', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Tobacco Research and Treatment Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Health Promotion and Resiliency and Intervention Research Program; Mongan Institute Health Policy Research Center, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America; Tobacco Research and Treatment Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106586']
1022,34149690,Epigenetic Features of HIV-Induced T-Cell Exhaustion Persist Despite Early Antiretroviral Therapy.,"T cell dysfunction occurs early following HIV infection, impacting the emergence of non-AIDS morbidities and limiting curative efforts. ART initiated during primary HIV infection (PHI) can reverse this dysfunction, but the extent of recovery is unknown. We studied 66 HIV-infected individuals treated from early PHI with up to three years of ART. Compared with HIV-uninfected controls, CD4 and CD8 T cells from early HIV infection were characterised by T cell activation and increased expression of the immune checkpoint receptors (ICRs) PD1, Tim-3 and TIGIT. Three years of ART lead to partial - but not complete - normalisation of ICR expression, the dynamics of which varied for individual ICRs. For HIV-specific cells, epigenetic profiling of tetramer-sorted CD8 T cells revealed that epigenetic features of exhaustion typically seen in chronic HIV infection were already present early in PHI, and that ART initiation during PHI resulted in only a partial shift of the epigenome to one with more favourable memory characteristics. These findings suggest that although ART initiation during PHI results in significant immune reconstitution, there may be only partial resolution of HIV-related phenotypic and epigenetic changes.",2021,"Compared with HIV-uninfected controls, CD4 and CD8 T cells from early HIV infection were characterised by T cell activation and increased expression of the immune checkpoint receptors (ICRs) PD1, Tim-3 and TIGIT.",['66 HIV-infected individuals treated from early PHI with up to three years of ART'],[],"['CD4 and CD8 T cells', 'T cell activation and increased expression of the immune checkpoint receptors (ICRs) PD1, Tim-3 and TIGIT']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1142553', 'cui_str': 'Primary HIV infection'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]",[],"[{'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C3537335', 'cui_str': 'TIMD3 Protein'}, {'cui': 'C2607657', 'cui_str': 'TIGIT protein, human'}]",66.0,0.165217,"Compared with HIV-uninfected controls, CD4 and CD8 T cells from early HIV infection were characterised by T cell activation and increased expression of the immune checkpoint receptors (ICRs) PD1, Tim-3 and TIGIT.","[{'ForeName': 'Genevieve E', 'Initials': 'GE', 'LastName': 'Martin', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Debattama R', 'Initials': 'DR', 'LastName': 'Sen', 'Affiliation': 'Department of Immunology, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Pace', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Robinson', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Meyerowitz', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Adland', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Thornhill', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Ane', 'Initials': 'A', 'LastName': 'Ogbe', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Parolini', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Olejniczak', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Zacharopoulou', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Christian B', 'Initials': 'CB', 'LastName': 'Willberg', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Nneka', 'Initials': 'N', 'LastName': 'Nwokolo', 'Affiliation': 'Chelsea and Westminster Hospital, London, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Fox', 'Affiliation': ""Department of Genitourinary Medicine and Infectious Disease, Guys and St Thomas' National Health Service (NHS) Trust, London, United Kingdom.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'Division of Medicine, Wright Fleming Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'W Nicholas', 'Initials': 'WN', 'LastName': 'Haining', 'Affiliation': 'Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Frater', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}]",Frontiers in immunology,['10.3389/fimmu.2021.647688']
1023,34618367,"Topical Cyperus rotundus essential oil for treatment of axillary hyperpigmentation: a randomized, double-blind, active- and placebo-controlled study.","BACKGROUND


The oil of the grass Cyperus rotundus (purple nutsedge) is an effective and safe treatment option for a variety of conditions. It has anti-inflammatory and antipigmenting properties. There have been no clinical trials comparing topical C. rotundus oil with skin-lightening treatments for axillary hyperpigmentation.
AIM


To assess the efficacy of C. rotundus essential oil (CREO) in treating axillary hyperpigmentation, and compare with another active treatment hydroquinone (HQ) and a placebo (cold cream) in this study.
METHODS


The study included 153 participants, who were assigned to one of three study groups: CREO, HQ group or placebo group. A tri-stimulus colorimeter was used to assess pigmentation and erythema. Two independent experts completed the Physician Global Assessment, and the patients completed a self-assessment questionnaire.
RESULTS


CREO had significantly (P < 0.001) better depigmenting effects than HQ. CREO and HQ did not differ significantly in terms of depigmentation effects (P > 0.05); however, there were statistically significant differences in anti-inflammatory effects and decrease in hair growth (P < 0.05) in favour of CREO.
CONCLUSIONS


CREO is a cost-effective and safe treatment for axillary hyperpigmentation.",2022,The essential oil of Cyperus rotundus is a cost-effective and safe treatment for axillary hyperpigmentation.,"['axillary hyperpigmentation', '153 participants and assigned to one of three study groups']","['Topical Cyperus rotundus Oil', 'hydroquinone and cold cream', 'C. rotundus oil group), (hydroquinone group), or (cold cream', 'placebo']","['anti-inflammatory and decreasing hair growth', 'depigmentation effects', 'Physician Global Assessment, and patient self-assessments']","[{'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0950026', 'cui_str': 'Cyperus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C0302231', 'cui_str': 'Cold cream'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0232407', 'cui_str': 'Hair growth'}, {'cui': 'C0162835', 'cui_str': 'Hypopigmentation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}]",153.0,0.187916,The essential oil of Cyperus rotundus is a cost-effective and safe treatment for axillary hyperpigmentation.,"[{'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Mohammed', 'Affiliation': 'Department of Dermatology, Venereology and Sexology, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}]",Clinical and experimental dermatology,['10.1111/ced.14959']
1024,34606578,Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial.,"Importance


The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.
Objective


To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19.
Design, Setting, and Participants


The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021.
Interventions


The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916).
Main Outcomes and Measures


The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, -1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events.
Results


Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11 secondary outcomes. Serious adverse events were reported in 3.0% (32/1075) of participants in the convalescent plasma group and in 1.3% (12/905) of participants in the no convalescent plasma group.
Conclusions and Relevance


Among critically ill adults with confirmed COVID-19, treatment with 2 units of high-titer, ABO-compatible convalescent plasma had a low likelihood of providing improvement in the number of organ support-free days.
Trial Registration


ClinicalTrials.gov Identifier: NCT02735707.",2021,"Serious adverse events were reported in 3.0% (32/1075) of participants in the convalescent plasma group and in 1.3% (12/905) of participants in the no convalescent plasma group.
","['Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults', 'Critically Ill Patients With COVID-19', 'critically ill adults with confirmed COVID-19, treatment with 2 units of high-titer, ABO-compatible convalescent plasma', 'critically ill patients with COVID-19', 'critically ill adults with COVID-19', '2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998']","['2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL\u2009±\u2009150 mL) within 48 hours of randomization (n\u2009=\u20091084) or no convalescent plasma', 'Convalescent Plasma', 'open-label interventions in the immunoglobulin domain']","['posterior probability of an odds ratio (OR', 'median number of organ support-free days', 'survival', 'median number of days alive and free of organ support', 'Serious adverse events', 'hospital mortality rate', 'organ support-free days (days alive and free of intensive care unit-based organ support', 'posterior probability of futility', 'hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events', 'median-adjusted OR']","[{'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1512665', 'cui_str': 'Immunoglobulin Domain'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086322', 'cui_str': 'Futility'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}]",4763.0,0.327326,"Serious adverse events were reported in 3.0% (32/1075) of participants in the convalescent plasma group and in 1.3% (12/905) of participants in the no convalescent plasma group.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Lise J', 'Initials': 'LJ', 'LastName': 'Estcourt', 'Affiliation': 'NHS Blood and Transplant, Oxford, England.'}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'Division of Critical Care Medicine, Department of Anesthesiology and Critical Care Medicine, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Zoe K', 'Initials': 'ZK', 'LastName': 'McQuilten', 'Affiliation': 'Transfusion Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'McVerry', 'Affiliation': 'Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Al-Beidh', 'Affiliation': 'Division of Anesthetics, Pain Medicine, and Intensive Care Medicine, Department of Surgery and Cancer, Imperial College London and Imperial College Healthcare NHS Trust, London, England.'}, {'ForeName': 'Djillali', 'Initials': 'D', 'LastName': 'Annane', 'Affiliation': 'Intensive Care Unit, Raymond Poincaré Hospital, Paris, France.'}, {'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': 'Intensive Care Department, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Arnold', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Beane', 'Affiliation': 'Nuffield Department of Clinical Medicine, University of Oxford, Oxford, England.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bégin', 'Affiliation': 'Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'van Bentum-Puijk', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Lindsay R', 'Initials': 'LR', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Bhimani', 'Affiliation': ""Li Ka Shing Knowledge Institute, Unity Health Toronto, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Birchall', 'Affiliation': 'Welsh Blood Service, Cardiff, Wales.'}, {'ForeName': 'Marc J M', 'Initials': 'MJM', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Bradbury', 'Affiliation': 'University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, England.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Brunkhorst', 'Affiliation': 'Center for Clinical Studies and Center for Sepsis Control and Care, Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Buxton', 'Affiliation': 'Global Coalition for Adaptive Research, San Francisco, California.'}, {'ForeName': 'Jeannie L', 'Initials': 'JL', 'LastName': 'Callum', 'Affiliation': 'Canadian Blood Services, Ottawa, Ontario, Canada.'}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Chassé', 'Affiliation': 'Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'Infection Prevention and Healthcare Epidemiology Unit, Alfred Health, Melbourne, Australia.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Cove', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Daly', 'Affiliation': 'Australian Red Cross Lifeblood, Sydney and Perth, Australia.'}, {'ForeName': 'Lennie', 'Initials': 'L', 'LastName': 'Derde', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Detry', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Menno', 'Initials': 'M', 'LastName': 'De Jong', 'Affiliation': 'Department of Medical Microbiology, University of Amsterdam Medical Center, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Evans', 'Affiliation': 'NHSBT Clinical Trials Unit, NHS Blood and Transplant, Cambridge, England.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Ottawa Hospital Research Institute, Clinical Epidemiology Unit, Ottawa, Ontario, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fish', 'Affiliation': 'School of Immunology and Microbial Sciences, Kings College London, London, England.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fitzgerald', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Foley', 'Affiliation': 'NHSBT Clinical Trials Unit, NHS Blood and Transplant, Cambridge, England.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Goossens', 'Affiliation': 'Department of Microbiology, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Division of Anesthetics, Pain Medicine, and Intensive Care Medicine, Department of Surgery and Cancer, Imperial College London and Imperial College Healthcare NHS Trust, London, England.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'Gosbell', 'Affiliation': 'Australian Red Cross Lifeblood, Sydney and Perth, Australia.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Rashan', 'Initials': 'R', 'LastName': 'Haniffa', 'Affiliation': 'Network for Improving Critical Care Systems and Training, Colombo, Sri Lanka.'}, {'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Harvala', 'Affiliation': 'NHS Blood and Transplant, London, England.'}, {'ForeName': 'Alisa M', 'Initials': 'AM', 'LastName': 'Higgins', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Hills', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Veronica C', 'Initials': 'VC', 'LastName': 'Hoad', 'Affiliation': 'Australian Red Cross Lifeblood, Sydney and Perth, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Horvat', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Huang', 'Affiliation': 'Department of Critical Care Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Cara L', 'Initials': 'CL', 'LastName': 'Hudson', 'Affiliation': 'NHSBT Clinical Trials Unit, Bristol, England.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Ichihara', 'Affiliation': 'Department of Healthcare Quality Assessment, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Laing', 'Affiliation': 'NHSBT Clinical Trials Unit, NHS Blood and Transplant, Cambridge, England.'}, {'ForeName': 'Abigail A', 'Initials': 'AA', 'LastName': 'Lamikanra', 'Affiliation': 'NHS Blood and Transplant, Oxford, England.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Lawler', 'Affiliation': 'Cardiac Intensive Care Unit, Peter Munk Cardiac Centre, University Health Network, Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Linstrum', 'Affiliation': 'Clinical Research Investigation and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'School of Medicine and Pharmacology, University of Western Australia, Crawley.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lorenzi', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'MacLennan', 'Affiliation': 'NHS Blood and Transplant, Barnsley, England.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': ""Li Ka Shing Knowledge Institute, Unity Health Toronto, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""Centre for Experimental Medicine, School of Medicine, Dentistry, and Biomedical Sciences, Queen's University Belfast, Belfast, Ireland.""}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'McDyer', 'Affiliation': 'Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McGlothlin', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Miflin', 'Affiliation': 'NHS Blood and Transplant, Bristol, England.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Montgomery', 'Affiliation': 'Clinical Research Investigation and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'School of Medicine, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Nichol', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parke', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Parker', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Priddee', 'Affiliation': 'Scottish National Blood Transfusion Service, Edinburgh, Scotland.'}, {'ForeName': 'Damian F J', 'Initials': 'DFJ', 'LastName': 'Purcell', 'Affiliation': 'Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Luis F', 'Initials': 'LF', 'LastName': 'Reyes', 'Affiliation': 'Universidad de La Sabana, Chia, Colombia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'Welsh Blood Service, Cardiff, Wales.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Robitaille', 'Affiliation': 'Héma-Québec, Montreal, Quebec, Canada.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rynne', 'Affiliation': 'School of Immunology and Microbial Sciences, Kings College London, London, England.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Department of Emergency and Critical Care Medicine, St Marianna University School of Medicine, Yokohama City Seibu Hospital, Yokohama, Japan.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Santos', 'Affiliation': ""Li Ka Shing Knowledge Institute, Unity Health Toronto, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Christina T', 'Initials': 'CT', 'LastName': 'Saunders', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa Neto', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Seymour', 'Affiliation': 'Clinical Research Investigation and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jon A', 'Initials': 'JA', 'LastName': 'Silversides', 'Affiliation': ""Centre for Experimental Medicine, School of Medicine, Dentistry, and Biomedical Sciences, Queen's University Belfast, Belfast, Ireland.""}, {'ForeName': 'Alan A', 'Initials': 'AA', 'LastName': 'Tinmouth', 'Affiliation': 'Ottawa Hospital Research Institute, Clinical Epidemiology Unit, Ottawa, Ontario, Canada.'}, {'ForeName': 'Darrell J', 'Initials': 'DJ', 'LastName': 'Triulzi', 'Affiliation': 'Department of Pathology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Turner', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van de Veerdonk', 'Affiliation': 'Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Walsh', 'Affiliation': 'University of Edinburgh, Edinburgh, Scotland.'}, {'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Wood', 'Affiliation': 'Transfusion Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Lewis', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Menon', 'Affiliation': ""University Division of Anesthesia, Addenbrooke's Hospital Cambridge, Cambridge, England.""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'Department of Medicine, Critical Care and Hematology/Medical Oncology, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Clinical Research Investigation and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Steve A', 'Initials': 'SA', 'LastName': 'Webb', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Roberts', 'Affiliation': 'NHS Blood and Transplant, Oxford, England.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Shankar-Hari', 'Affiliation': 'School of Immunology and Microbial Sciences, Kings College London, London, England.'}]",JAMA,['10.1001/jama.2021.18178']
1025,34606574,Cardiovascular Safety and Hemostatic Efficacy of Topical Epinephrine in Children Receiving Zirconia Crowns.,"OBJECTIVE


The primary aim of this study was to determine the cardiovascular safety of topical racemic epinephrine pellets by measuring heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure in children receiving dental care under general anesthesia. The secondary aim was to assess clinical efficacy by measuring time to reach adequate hemostasis.
METHODS


For this pilot study utilizing a split-mouth randomized design, 13 patients requiring prefabricated zirconia crowns on both primary maxillary first molars were recruited. Patients received continuous infusions of propofol and remifentanil with 50-70% inhaled nitrous oxide and oxygen. After randomization and tooth preparation, either saline pellets (control) or racemic epinephrine pellets (experimental) were applied directly to gingival tissue. Vital signs were recorded for 5 minutes. The procedure was repeated on the contralateral side using the alternative (control or experimental) treatment.
RESULTS


Topical racemic epinephrine compared to saline produced a significantly larger decrease in mean diastolic blood pressure (-11.1% vs -3.9%; P < .01) and mean arterial pressure (-8.1% vs -2.1%; P < .01), although all noted decreases in cardiovascular variables were clinically insignificant. All experimental treatment teeth achieved adequate hemostasis after 2.2 minutes. Only 5 of the 13 control treatment teeth achieved adequate hemostasis during the 5-minute observation period (1.6 vs 4.2 minutes; P = .01).
CONCLUSION


Overall, we conclude that use of topical racemic epinephrine pellets did not result in adverse cardiovascular effects and hemostasis was reached more quickly and predictably compared to saline pellets.",2021,"RESULTS


Topical racemic epinephrine compared to saline produced a significantly larger decrease in mean diastolic blood pressure (-11.1% vs -3.9%; P < .01) and mean arterial pressure (-8.1% vs -2.1%; P < .01), although all noted decreases in cardiovascular variables were clinically insignificant.","['children receiving dental care under general anesthesia', 'Children Receiving Zirconia Crowns', '13 patients requiring prefabricated zirconia crowns on both primary maxillary first molars were recruited']","['propofol and remifentanil with 50-70% inhaled nitrous oxide and oxygen', 'Topical Epinephrine', 'saline pellets (control) or racemic epinephrine pellets (experimental', 'topical racemic epinephrine', 'Topical racemic epinephrine']","['cardiovascular variables', 'adverse cardiovascular effects and hemostasis', 'Cardiovascular Safety and Hemostatic Efficacy', 'mean arterial pressure', 'heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure', 'adequate hemostasis', 'clinical efficacy', 'mean diastolic blood pressure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3218184', 'cui_str': 'Epinephrine-containing product in cutaneous dose form'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0441436', 'cui_str': 'Pellet gun missile'}, {'cui': 'C0205758', 'cui_str': 'Racepinephrine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",13.0,0.0755716,"RESULTS


Topical racemic epinephrine compared to saline produced a significantly larger decrease in mean diastolic blood pressure (-11.1% vs -3.9%; P < .01) and mean arterial pressure (-8.1% vs -2.1%; P < .01), although all noted decreases in cardiovascular variables were clinically insignificant.","[{'ForeName': 'Afsoon', 'Initials': 'A', 'LastName': 'Fazeli', 'Affiliation': 'Department of Pediatric Dentistry, University of Washington, Seattle, Washington.'}, {'ForeName': 'Travis M', 'Initials': 'TM', 'LastName': 'Nelson', 'Affiliation': 'Department of Pediatric Dentistry, University of Washington, Seattle, Washington.'}, {'ForeName': 'Mir Sohail', 'Initials': 'MS', 'LastName': 'Fazeli', 'Affiliation': 'Evidinno Outcomes Research Inc, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Yvonne S', 'Initials': 'YS', 'LastName': 'Lin', 'Affiliation': 'Department of Pharmaceutics, University of Washington, Seattle, Washington.'}, {'ForeName': 'JoAnna', 'Initials': 'J', 'LastName': 'Scott', 'Affiliation': 'University of Missouri-Kansas City School of Dentistry, Kansas City, Missouri.'}]",Anesthesia progress,['10.2344/anpr-68-02-05']
1026,34612489,Corrigendum to: Long-Term Effectiveness of Oral Ferric Maltol vs Intravenous Ferric Carboxymaltose for the Treatment of Iron-Deficiency Anemia in Patients With Inflammatory Bowel Disease: A Randomized Controlled Noninferiority Trial.,,2022,,['Patients With Inflammatory Bowel Disease'],['Oral Ferric Maltol vs Intravenous Ferric Carboxymaltose'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0060237', 'cui_str': 'ferric maltol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}]",[],,0.103993,,"[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Howaldt', 'Affiliation': 'Research Institute for IBD-HaFCED e.K., Hamburg, Germany.'}, {'ForeName': 'Eugeni', 'Initials': 'E', 'LastName': 'Domènech', 'Affiliation': 'Gastroenterology and Hepatology Department, Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, and Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Madrid, Spain.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Martinez', 'Affiliation': 'Gastroenterology Research of America, San Antonio, Texas, USA.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schmidt', 'Affiliation': 'Department of Gastroenterology, Hepatology, Endocrinology, Diabetology, and Infectious Diseases, Klinikum Fulda, Fulda, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Bokemeyer', 'Affiliation': 'Gastroenterology Practice Minden and University Hospital Schleswig-Holstein, Campus Kiel, Clinic for Internal Medicine I, Kiel, Germany.'}]",Inflammatory bowel diseases,['10.1093/ibd/izab224']
1027,34620545,Sexual Communication and Sexual Consent Self-Efficacy Among College Students: Implications for Sexually Transmitted Infection Prevention.,"PURPOSE


Obtaining affirmative consent, a hallmark of sexual violence prevention education on college campuses, may influence sexual communication and behaviors such as condom use. This study examined the relationship between self-efficacy to obtain sexual consent with sexual health communication and behaviors among a sample of U.S. college students.
METHODS


Data were from 2,291 students enrolled in a cluster-randomized controlled trial conducted on 28 college campuses from 2015 to 2017. Students reported their self-efficacy to obtain sexual consent, communication about sexual health, and sexual health behaviors. Multivariable logistic regression, adjusted for school clustering, history of violence victimization, and sexually transmitted infection history, estimated odds ratios and 95% confidence intervals (CIs) for sexual consent self-efficacy and sexual health communication.
RESULTS


Females (n = 1,150) reported higher self-efficacy to obtain consent than males (b 1  = .32, 95% CI = .23, .41), but lower odds of communication about condom use (adjusted odds ratio [AOR] = .75, 95% CI = .60, .96) and HIV prevention (AOR = .63, 95% CI = .48, .81). Black and other race students reported higher odds of HIV/sexually transmitted infection prevention communication than white students. Odds of consistent condom use were highest among students reporting condom use communication and high self-efficacy to obtain sexual consent (AOR = 1.99, 95% CI = 1.58, 2.51).
CONCLUSIONS


Campus sexual assault prevention education that focuses narrowly on obtaining sexual consent may be missing an opportunity to enhance sexual health communication broadly, including condom and contraceptive use discussion to promote overall sexual health.",2022,Odds of consistent condom use were highest among students reporting condom use communication and high self-efficacy to obtain sexual consent (AOR = 1.99,"['College Students', 'sample of U.S. college students', 'Data were from 2,291 students enrolled in a cluster-randomized controlled trial conducted on 28 college campuses from 2015 to 2017']",[],"['Sexual Communication and Sexual Consent Self-Efficacy', 'self-efficacy to obtain sexual consent, communication about sexual health, and sexual health behaviors', 'sexual consent self-efficacy and sexual health communication', 'HIV prevention', 'higher self-efficacy']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",[],"[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0205250', 'cui_str': 'High'}]",2291.0,0.062339,Odds of consistent condom use were highest among students reporting condom use communication and high self-efficacy to obtain sexual consent (AOR = 1.99,"[{'ForeName': 'Briana', 'Initials': 'B', 'LastName': 'Edison', 'Affiliation': ""Department of Infectious Diseases & Microbiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania; Division of Adolescent and Young Adult Medicine, Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. Electronic address: bredison17@gmail.com.""}, {'ForeName': 'Robert W S', 'Initials': 'RWS', 'LastName': 'Coulter', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; Department of Behavioral and Community Health Sciences, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Lynissa R', 'Initials': 'LR', 'LastName': 'Stokes', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Ashley V', 'Initials': 'AV', 'LastName': 'Hill', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2021.08.012']
1028,34619378,Effect of desflurane on changes in regional cerebral oxygenation in patients undergoing one-lung ventilation is equivalent to the effect of propofol.,"OBJECTIVES


Desaturation is an important clinical problem during one-lung ventilation (OLV) since it may induce cerebral hypoxia. Measurement of cerebral oxygenation has been shown to provide accurate information about episodes of cerebral hypoxemia. The purpose of this study was to compare the effect of desflurane on changes in cerebral oxygenation during OLV with the effect of propofol.
METHODS


A randomized, single-blinded, prospective study was conducted. Fifty adult patients who were scheduled to undergo thoracic surgery were randomly assigned to anesthetic management using desflurane with remifentanil (Group D: n = 25) or using propofol and remifentanil (Group P: n = 25).
RESULTS


The characteristics of the patients were very similar. Intergroup analysis of changes in cerebral oxygenation showed no significant difference on the operative side (two-way ANOVA, F (7, 368) = 0.425, p = 0.887) or the non-operative side (two-way ANOVA, F (7, 367) = 1.342, p = 0.229). Intragroup analysis of changes in cerebral oxygenation using one-way ANOVA showed no significant difference on the operative side (Group P; p = 0.585, Group D; p = 0.928) or the non-operative side in both groups (Group P; p = 0.657, Group D; p = 0.602).
CONCLUSIONS


The effects of desflurane and propofol on changes in cerebral oxygenation in patients undergoing OLV were equivalent. Our results indicated that desflurane might be an appropriate anesthetic during OLV for maintaining cerebral oxygenation with an effective equivalent to that of propofol.",2022,"Intergroup analysis of changes in cerebral oxygenation showed no significant difference on the operative side (two-way ANOVA, F (7, 368) = 0.425, p = 0.887) or the non-operative side (two-way ANOVA, F (7, 367) = 1.342, p = 0.229).","['patients undergoing one-lung ventilation', 'Fifty adult patients who were scheduled to undergo thoracic surgery', 'patients undergoing OLV']","['desflurane with remifentanil', 'desflurane', 'propofol and remifentanil', 'propofol', 'desflurane and propofol']","['cerebral oxygenation', 'regional cerebral oxygenation', 'operative side']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0205147', 'cui_str': 'Regional'}]",50.0,0.0447102,"Intergroup analysis of changes in cerebral oxygenation showed no significant difference on the operative side (two-way ANOVA, F (7, 368) = 0.425, p = 0.887) or the non-operative side (two-way ANOVA, F (7, 367) = 1.342, p = 0.229).","[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, West 16, South 1, Chuo-ward, Sapporo, Hokkaido, 060-8543, Japan. Electronic address: sucrose0711@gmail.com.'}, {'ForeName': 'Mitsutaka', 'Initials': 'M', 'LastName': 'Edanaga', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, West 16, South 1, Chuo-ward, Sapporo, Hokkaido, 060-8543, Japan.'}, {'ForeName': 'Mamiko', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, West 16, South 1, Chuo-ward, Sapporo, Hokkaido, 060-8543, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, West 16, South 1, Chuo-ward, Sapporo, Hokkaido, 060-8543, Japan.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2021.103798']
1029,34609726,Endovascular renal sympathetic denervation to improve heart failure with reduced ejection fraction: the IMPROVE-HF-I study.,"INTRODUCTION


The aim of the present study was to assess the safety and efficacy of renal sympathetic denervation (RDN) in patients with heart failure with reduced ejection fraction (HFrEF).
METHODS


We randomly assigned 50 patients with a left ventricular ejection fraction (LVEF) ≤ 35% and NYHA class ≥ II, in a 1:1 ratio, to either RDN and optimal medical therapy (OMT) or OMT alone. The primary safety endpoint was the occurrence of a combined endpoint of cardiovascular death, rehospitalisation for heart failure, and acute kidney injury at 6 months. The primary efficacy endpoint was the change in iodine-123 meta-iodobenzylguanidine ( 123 I‑MIBG) heart-to-mediastinum ratio (HMR) at 6 months.
RESULTS


Mean age was 60 ± 9 years, 86% was male and mean LVEF was 33 ± 8%. At 6 months, the primary safety endpoint occurred in 8.3% vs 8.0% in the RDN and OMT groups, respectively (p = 0.97). At 6 months, the mean change in late HMR was -0.02 (95% CI: -0.08 to 0.12) in the RDN group, versus -0.02 (95% CI: -0.09 to 0.12) in the OMT group (p = 0.95) whereas the mean change in washout rate was 2.34 (95% CI: -6.35 to 1.67) in the RDN group versus -2.59 (95% CI: -1.61 to 6.79) in the OMT group (p-value 0.09).
CONCLUSION


RDN with the Vessix system in patients with HFrEF was safe, but did not result in significant changes in cardiac sympathetic nerve activity at 6 months as measured using  123 I‑MIBG.",2022,"RDN with the Vessix system in patients with HFrEF was safe, but did not result in significant changes in cardiac sympathetic nerve activity at 6 months as measured using  123 I‑MIBG.","['Mean age was 60\u202f±\u20099\xa0years, 86% was male and mean LVEF was 33\u202f±\u20098', 'patients with heart failure with reduced ejection fraction (HFrEF']","['left ventricular ejection fraction (LVEF) ≤\u202f35% and NYHA class ≥\u202fII, in a\xa01:1\xa0ratio, to either RDN and optimal medical therapy (OMT) or OMT alone', 'Endovascular renal sympathetic denervation', 'renal sympathetic denervation (RDN', 'OMT']","['primary safety endpoint', 'safety and efficacy', 'mean change in late HMR', 'cardiac sympathetic nerve activity', 'heart failure', 'change in iodine-123 meta-iodobenzylguanidine ( 123 I‑MIBG) heart-to-mediastinum ratio (HMR', 'occurrence of a\xa0combined endpoint of cardiovascular death, rehospitalisation for heart failure, and acute kidney injury at 6\xa0months', 'mean change in washout rate']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0039038', 'cui_str': 'Sympathectomy'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0025066', 'cui_str': 'Mediastinal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0228992', 'cui_str': 'Structure of middle cardiac nerve'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3495673', 'cui_str': 'IODIDE ION I-123'}, {'cui': 'C0047506', 'cui_str': '3-Iodobenzylguanidine'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.16968,"RDN with the Vessix system in patients with HFrEF was safe, but did not result in significant changes in cardiac sympathetic nerve activity at 6 months as measured using  123 I‑MIBG.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Feyz', 'Affiliation': 'University Medical Center, Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Nannan Panday', 'Affiliation': 'University Medical Center, Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Henneman', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Verzijlbergen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Constantinescu', 'Affiliation': 'University Medical Center, Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'van Dalen', 'Affiliation': 'University Medical Center, Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Brugts', 'Affiliation': 'University Medical Center, Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Caliskan', 'Affiliation': 'University Medical Center, Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Geleijnse', 'Affiliation': 'University Medical Center, Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kardys', 'Affiliation': 'University Medical Center, Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'University Medical Center, Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Manintveld', 'Affiliation': 'University Medical Center, Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Daemen', 'Affiliation': 'University Medical Center, Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands. j.daemen@erasmusmc.nl.'}]",Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation,['10.1007/s12471-021-01633-z']
1030,34613416,Telavancin pharmacokinetics in patients with chronic kidney disease receiving haemodialysis.,"BACKGROUND


Telavancin is a lipoglycopeptide antibiotic with limited pharmacokinetic data to guide drug dosing in patients receiving haemodialysis.
OBJECTIVES


This study characterized telavancin pharmacokinetics in patients receiving haemodialysis.
PATIENTS AND METHODS


This was a Phase IV, prospective, open-label, single-centre, crossover pharmacokinetic study (ClinicalTrials.gov: NCT02392208). Eight subjects with end-stage kidney disease requiring maintenance haemodialysis (mean ± SD: 47 ± 20 years, 69.5 ± 17.1 kg) received 5 mg/kg telavancin IV 3 h before starting a 3.5 hour haemodialysis treatment with a high-permeability haemodialyser (haemodialysis period). After a 14 day washout period, a second 5 mg/kg dose was administered post-haemodialysis (control period). Telavancin plasma concentrations were measured over a 2 day period after each dose and non-compartmental pharmacokinetic analyses were performed.
RESULTS


The geometric mean (GM) of telavancin overall clearance was 11.2 mL/h/kg (intrinsic clearance and dialytic clearance) in the haemodialysis period and 5.9 mL/h/kg (off-haemodialysis clearance) in the control period [GM ratio (GMR) = 1.89; 90% CI: 1.70-2.10; P < 0.01]. The GM t½ was 13.1 h when haemodialysis occurred 3 h post-dosing in the haemodialysis period but extended to 20.9 h with post-haemodialysis dosing in the control period (GMR = 0.63; 90% CI: 0.54-0.73; P < 0.01). The GM of telavancin plasma concentrations removed by haemodialysis was 27.7%. The GMR of peak plasma concentration and volume of distribution of the haemodialysis period and the control period were 0.88 (90% CI: 0.79-0.98; P = 0.08) and 1.17 (90% CI: 1.05-1.30; P = 0.048), respectively.
CONCLUSIONS


Haemodialysis with high-permeability haemodialysers removes telavancin considerably (∼⅓ of body load). Telavancin 5 mg/kg every 48 h post-haemodialysis dosing is recommended, but dose adjustments may be warranted if haemodialysis starts within 3 h of telavancin administration.",2021,[GM ratio (GMR) = 1.89; 90% CI: 1.70-2.10; P < 0.01].,"['Eight subjects with end-stage kidney disease requiring maintenance haemodialysis (mean\u200a±\u200aSD: 47\u200a±\u200a20 years, 69.5\u200a±\u200a17.1 kg) received', 'patients with chronic kidney disease receiving haemodialysis', 'patients receiving haemodialysis']","['Telavancin', '5 mg/kg telavancin IV 3 h before starting a 3.5 hour haemodialysis treatment with a high-permeability haemodialyser (haemodialysis period', 'Telavancin pharmacokinetics']","['telavancin plasma concentrations', 'geometric mean (GM) of telavancin overall clearance', 'Telavancin plasma concentrations', 'GMR of peak plasma concentration and volume of distribution of the haemodialysis period']","[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C1453642', 'cui_str': 'telavancin'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]","[{'cui': 'C1453642', 'cui_str': 'telavancin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]",8.0,0.0362349,[GM ratio (GMR) = 1.89; 90% CI: 1.70-2.10; P < 0.01].,"[{'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Gharibian', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Lewis', 'Affiliation': 'Department of Pharmacy Practice, University of Findlay College of Pharmacy, Findlay, OH, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heung', 'Affiliation': 'Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Segal', 'Affiliation': 'Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Noha N', 'Initials': 'NN', 'LastName': 'Salama', 'Affiliation': 'Department of Pharmaceutics and Industrial Pharmacy, Cairo University Faculty of Pharmacy, Cairo, Egypt.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Mueller', 'Affiliation': 'Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, MI, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkab370']
1031,34612724,"Long-Term Safety and Efficacy of Blonanserin Oral Tablet in Adolescents with Schizophrenia: A 52-Week, Multicenter, Open-Label Extension Study.","Objectives:  To evaluate the long-term efficacy and safety/tolerability of oral blonanserin in adolescents with schizophrenia (Study registration number: JapicCTI-111725).  Methods:  This 52-week, multicenter, open-label extension study enrolled adolescent patients with schizophrenia who opted to enter in this study after the completion of the preceding placebo-controlled study. Blonanserin tablet was orally administered twice daily, after morning and evening meals, for 52 weeks using dose-titration method within a range between 4 and 24 mg/day. The primary end point was the change from baseline to the end of the study in the Positive and Negative Syndrome Scale (PANSS) total score. Safety/tolerability was assessed by the incidence and severity of adverse events.  Results:  Of 117 patients who completed the preceding placebo-controlled study, 109 entered this extension study and 43 (39.4%) of them discontinued the study treatment. The safety analysis set comprised 106 patients who received the study drug at least once, including 36 and 70 patients treated with placebo (DB-placebo group) and blonanserin tablet (DB-blonanserin group), respectively, in the placebo-controlled study. At the last assessment, the mean change in PANSS total score overall [mean (standard deviation)] was -24.9 (20.76) from the baseline of the placebo-controlled study, which was similar in the DB-placebo and DB-blonanserin groups. The overall incidence of adverse events was 90.6%, and most of them were mild or moderate in severity, with similar incidence of extrapyramidal symptoms (38.7%) to that in adults receiving long-term blonanserin oral tablet treatment and minimal change in weight and metabolic parameters.  Conclusions:  This long-term extension study showed that 52 weeks of oral blonanserin treatment improved or stabilized psychiatric symptoms in patients with adolescent schizophrenia. There were no major issues with the safety or tolerability of blonanserin administration in this study. Considering relatively less adverse effects on weight increase and metabolic parameters, blonanserin is expected to be a safe/tolerable treatment option for adolescent schizophrenia that can be used seamlessly from adolescence to adulthood.",2022,This long-term extension study showed that 52 weeks of oral blonanserin treatment improved or stabilized psychiatric symptoms in patients with adolescent schizophrenia.,"['adolescents with schizophrenia (Study registration number: JapicCTI-111725', 'enrolled adolescent patients with schizophrenia who opted to enter in this study after the completion of the preceding placebo-controlled study', '106 patients who received the study drug at least once, including 36 and 70 patients treated with', 'Adolescents with Schizophrenia', '117 patients who completed the preceding placebo-controlled study, 109 entered this extension study and 43 (39.4%) of them discontinued the study treatment', 'patients with adolescent schizophrenia']","['blonanserin', 'oral blonanserin', 'Blonanserin Oral Tablet', 'placebo (DB-placebo', 'blonanserin tablet (DB-blonanserin', 'Blonanserin']","['Positive and Negative Syndrome Scale (PANSS) total score', 'Safety/tolerability', 'extrapyramidal symptoms', 'safety or tolerability', 'overall incidence of adverse events', 'weight and metabolic parameters', 'stabilized psychiatric symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0993159', 'cui_str': 'Oral tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}]",117.0,0.0982782,This long-term extension study showed that 52 weeks of oral blonanserin treatment improved or stabilized psychiatric symptoms in patients with adolescent schizophrenia.,"[{'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Hyodo', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Chuo-Ku, Tokyo, Japan.'}, {'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Sakaguchi', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Chuo-Ku, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Chuo-Ku, Tokyo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ishigooka', 'Affiliation': 'Institute of CNS Pharmacology, Shibuya-ku, Tokyo, Japan.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2021.0058']
1032,34611745,Virtual reality versus optokinetic stimulation in visual vertigo rehabilitation.,"BACKGROUND


Visual vertigo (VV) is a condition at which there is worsening or triggering of vestibular symptoms in certain visual environments with large size (full field) repetitive or moving visual patterns as shopping malls.
PURPOSE


This work was designed to study effect of virtual reality and optokinetic stimulation on rehabilitation of VV.
METHOD


A total of 60 subjects divided into 2 groups that were simply randomized by the concealed envelope method: Group I consisted of 30 VV patients underwent vestibular rehabilitation using virtual reality. Group II consisted of 30 VV patients underwent vestibular rehabilitation using optokinetic stimulation.
RESULTS


Significant improvement in performance in the two groups after rehabilitation with no statistically significant difference when comparing both groups.
CONCLUSIONS


A combined intense rehabilitation program including OPK stimulation or VR rehabilitation combined with home-based exercises appeared to be equally effective for management of patients with VV and improving their quality of life.",2022,A combined intense rehabilitation program including OPK stimulation or VR rehabilitation combined with home-based exercises appeared to be equally effective for management of patients with VV and improving their quality of life.,"['60 subjects divided into 2 groups that were simply randomized by the concealed envelope method: Group I consisted of 30 VV patients underwent', 'visual vertigo rehabilitation']","['Virtual reality versus optokinetic stimulation', 'virtual reality and optokinetic stimulation', 'VR rehabilitation combined with home-based exercises', 'vestibular rehabilitation using virtual reality', 'vestibular rehabilitation using optokinetic stimulation']",['quality of life'],"[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0522360', 'cui_str': 'Persistent postural perceptual dizziness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.00356753,A combined intense rehabilitation program including OPK stimulation or VR rehabilitation combined with home-based exercises appeared to be equally effective for management of patients with VV and improving their quality of life.,"[{'ForeName': 'Alaa El-Sayed', 'Initials': 'AE', 'LastName': 'Mandour', 'Affiliation': 'Faculty of Medicine, Tanta University, Tanta, 1666, Egypt. alaa.ismaeil@med.tanta.edu.eg.'}, {'ForeName': 'Amani Mohamed', 'Initials': 'AM', 'LastName': 'El-Gharib', 'Affiliation': 'Faculty of Medicine, Tanta University, Tanta, 1666, Egypt.'}, {'ForeName': 'Afaf Ahmad', 'Initials': 'AA', 'LastName': 'Emara', 'Affiliation': 'Faculty of Medicine, Tanta University, Tanta, 1666, Egypt.'}, {'ForeName': 'Trandil Hassan', 'Initials': 'TH', 'LastName': 'Elmahallawy', 'Affiliation': 'Faculty of Medicine, Tanta University, Tanta, 1666, Egypt.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-021-07091-y']
1033,34623746,"Surgical closure, mainly with glue injection and anti-tumour necrosis factor α, in fistulizing perianal Crohn's disease: A multicentre randomized controlled trial.","AIM


In patients with fistulizing perianal Crohn's disease (CD), the need for a secondary surgical step is not defined. The aim was to assess the efficacy of surgical closure compared to a single seton removal in patients with drained fistulizing perianal CD treated with adalimumab.
METHODS


This was a multicentre, randomized controlled trial, comparing seton removal + surgical closure (closure group) to seton removal alone (control group) with a stratification according to the American Gastroenterological Association classification. The primary end-point was fistula closure at month 12 defined by the association of the following criteria: no seton, absence of a visible external opening, absence of discharge from the tract after finger compression, absence of an internal opening, absence of perianal pain/abscess and absence of fistula-related abnormalities.
RESULTS


Among the 64 included patients (262 expected) (48 complex fistula, 75%), 33 were randomized to the closure group and 31 to the control group. In the closure group, 26 patients (78.8%) had glue. At month 12, overall fistula closure was achieved in 35 of the evaluable 58 patients (60%): 18/32 (56%) in the surgery group and 17/26 (65%) in the control group (P = 0.479). In the closure group, fistula closure was observed in 13/25 (52%) and 5/7 (71%) patients with complex and simple fistula respectively (P = 0.426), compared with 12/18 (67%) and 5/8 (63%), respectively in the control group (P = 1.000).
CONCLUSIONS


Seton removal alone seems to be no more effective than a secondary surgical step (in particular glue injection) in patients having fistulizing perianal CD controlled by an initial drainage combined with adalimumab. The results should be interpreted with caution.",2022,"At month 12, overall fistula closure was achieved in 35 of the evaluable 58 patients (60%): 18/32 (56%) in the surgery group and 17/26 (65%) in the control group (p=0.479).","[""patients with fistulizing perianal Crohn's Disease (FPCD"", 'patients with drained FPCD treated by', '64 included patients (262 expected) (48 complex fistula, 75%), 33 were randomized to the closure group and 31 to the control group', ""fistulizing perianal crohn's disease""]","['surgical closure', 'adalimumab', 'seton removal + surgical closure [closure group] to seton removal alone [control group', 'glue injection and anti tnf alpha']","['fistula closure', 'seton, absence of a visible external opening, absence of discharge from the tract after finger compression, absence of an internal opening, absence of perianal pain/abscess and absence of fistula-related abnormalities', 'overall fistula closure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341395', 'cui_str': ""Perianal Crohn's disease""}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0185003', 'cui_str': 'Closure'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}]","[{'cui': 'C0441508', 'cui_str': 'Fistula repair'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0585134', 'cui_str': 'Perianal pain'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0539659,"At month 12, overall fistula closure was achieved in 35 of the evaluable 58 patients (60%): 18/32 (56%) in the surgery group and 17/26 (65%) in the control group (p=0.479).","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Abramowitz', 'Affiliation': ""Service d'Hépato-gastroentérologie et Proctologie, Hôpital Bichat-Claude Bernard, Paris, France.""}, {'ForeName': 'Charlène', 'Initials': 'C', 'LastName': 'Brochard', 'Affiliation': ""Service des Maladies de l'Appareil Digestif, CHU Pontchaillou, Université de Rennes 1, Rennes, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Pigot', 'Affiliation': 'Service de Proctologie, Hôpital Bagatelle, Maison de Santé Protestante Bagatelle, Talence, France.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Roumeguere', 'Affiliation': 'Clinique Tivoli-Ducos, Bordeaux, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Pillant', 'Affiliation': 'Service de Proctologie, Groupe Hospitalier Paris Saint Joseph, Institut Léopold-Bellan, Paris, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Vinson Bonnet', 'Affiliation': 'Service de Chirurgie Viscérale et Digestive, CHI, Poissy-St-Germain-en-Laye, Paris, France.'}, {'ForeName': 'Jean Luc', 'Initials': 'JL', 'LastName': 'Faucheron', 'Affiliation': ""Unité de Chirurgie Colo-rectale, Service de Chirurgie Digestive et de l'Urgence, Hôpital Michallon, CHUGA, Grenoble, France.""}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Senéjoux', 'Affiliation': 'CHP Saint-Grégoire, Saint-Grégoire, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bonnaud', 'Affiliation': 'Clinique Ambroise Paré, Toulouse, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Meurette', 'Affiliation': ""Clinique de Chirurgie Digestive et Endocrinienne (CCDE), Institut des Maladies de l'Appareil Digestif (IMAD), University Hospital of Nantes, Nantes, France.""}, {'ForeName': 'Jean Marie', 'Initials': 'JM', 'LastName': 'Fayette', 'Affiliation': 'Société ClinSearch, Malakoff, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Train', 'Affiliation': 'Société ClinSearch, Malakoff, France.'}, {'ForeName': 'Ghislain', 'Initials': 'G', 'LastName': 'Staumont', 'Affiliation': 'Clinique Saint-Jean-Languedoc, Toulouse, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Siproudhis', 'Affiliation': ""Service des Maladies de l'Appareil Digestif, CHU Pontchaillou, Université de Rennes 1, Rennes, France.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Bouchard', 'Affiliation': 'Service de Proctologie, Hôpital Bagatelle, Maison de Santé Protestante Bagatelle, Talence, France.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15947']
1034,34622433,Low-dose ticagrelor with or without acetylsalicylic acid in patients with acute coronary syndrome: Rationale and design of the ELECTRA-SIRIO 2 trial.,,2022,,['patients with acute coronary syndrome'],['Low-dose ticagrelor with or without acetylsalicylic acid'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]",[],,0.111501,,"[{'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kubica', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Adamski', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland. piotr.adamski@wp.eu.'}, {'ForeName': 'Diana A', 'Initials': 'DA', 'LastName': 'Gorog', 'Affiliation': 'Postgraduate Medical School, University of Hertfordshire, Stevenage, United Kingdom.'}, {'ForeName': 'Aldona', 'Initials': 'A', 'LastName': 'Kubica', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Jilma', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Poland, Austria.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Budaj', 'Affiliation': 'Center of Postgraduate Medical Education, Grochowski Hospital, Warsaw, Poland.'}, {'ForeName': 'Jolanta M', 'Initials': 'JM', 'LastName': 'Siller-Matula', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Poland, Austria.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gurbel', 'Affiliation': 'Sinai Center for Thrombosis Research and Drug Development, Sinai Hospital, Life Bridge Health System, Baltimore, MD, United States.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Alexopoulos', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Jolita', 'Initials': 'J', 'LastName': 'Badarienė', 'Affiliation': 'Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Dąbrowski', 'Affiliation': 'Department of Cardiology, The Pope John Paul II Hospital, Zamosc, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': 'Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Giannitsis', 'Affiliation': 'Medizinische Klinik III, Department of Cardiology, Angiology and Pulmology, University Hospital of Heidelberg, Germany.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Horszczaruk', 'Affiliation': 'Department of Cardiology, Voivodeship Hospital, Lomza, Poland.'}, {'ForeName': 'Miłosz J', 'Initials': 'MJ', 'LastName': 'Jaguszewski', 'Affiliation': '1st Department of Cardiology, Medical University of Gdansk, Poland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Young-Hoon', 'Initials': 'YH', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Cardiovascular Center, Gyeongsang National University Changwon Hospital, Changwon, South Korea.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Kryjak', 'Affiliation': 'Department of Cardiology, The Doctor Sokolowski Hospital, Walbrzych, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Niezgoda', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Ostrowska', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Patti', 'Affiliation': 'University of Eastern Piemont, Maggiore della Carità Hospital, Novara, Italy.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Romanek', 'Affiliation': 'Cardiology Department with the Acute Coronary Syndromes Subdivision, Clinical Provincial Hospital No. 2, Faculty of Medicine, University of Rzeszow, Poland.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Di Somma', 'Affiliation': 'Department of Medical-Surgery Sciences and Translational Medicine, University La Sapienza, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Specchia', 'Affiliation': 'Pavia, Italy.'}, {'ForeName': 'Udaya', 'Initials': 'U', 'LastName': 'Tantry', 'Affiliation': 'Sinai Center for Thrombosis Research and Drug Development, Sinai Hospital, Life Bridge Health System, Baltimore, MD, United States.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Gąsior', 'Affiliation': '3rd Department of Cardiology, Silesian Center for Heart Diseases, Faculty of Medicine in Zabrze, Medical University of Silesia, Zabrze, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Tycińska', 'Affiliation': 'Department of Cardiology, Medical University of Bialystok, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Wojakowski', 'Affiliation': 'Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Buszko', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gil', 'Affiliation': 'Department of Invasive Cardiology, Center of Postgraduate Medical Education, Central Hospital of the Internal Affairs and Administration Ministry, Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Gruchała', 'Affiliation': '1st Department of Cardiology, Medical University of Gdansk, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Kasprzak', 'Affiliation': '1st Department and Chair of Cardiology, Medical University of Lodz, Bieganski Hospital, Lodz, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Kleinrok', 'Affiliation': 'Department of Cardiology, The Pope John Paul II Hospital, Zamosc, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Legutko', 'Affiliation': 'Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College and John Paul II Hospital in Krakow, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Lesiak', 'Affiliation': 'Chair and 1st Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Eliano P', 'Initials': 'EP', 'LastName': 'Navarese', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland.'}]",Cardiology journal,['10.5603/CJ.a2021.0118']
1035,34622430,Emotional and Attentional Bias in Fibromyalgia: A Pilot ERP Study of the Dot-Probe Task.,"INTRODUCTION


The present research investigates the neural correlates of attentional bias in fibromyalgia (FM) with a dot-probe task performed during an electroencephalogram (EEG) recording.
METHODS


For this purpose, 30 female participants were recruited, divided into two groups: a group of patients with FM (FM, n = 15, M age  = 51.87) and a healthy control group (HC) (HC, n = 15, M age  = 46.13).
RESULTS


The results did not show behavioral differences between groups, but the EEG results showed that healthy controls had larger P300 amplitudes than patients with FM. Regarding late positive potentials (LPP), we found that patients with FM had larger amplitudes than healthy controls in a later time window.
CONCLUSION


In summary, while the P300 results suggest that patients allocate less attentional resources to the task, the increased amplitudes of their LPP suggest augmented emotional processing of the target stimuli. Altogether, our results seem to support the thesis of generalized attentional deficits in FM.",2021,"The results did not show behavioral differences between groups, but the EEG results showed that healthy controls had larger P300 amplitudes than patients with FM.","['Fibromyalgia', '30 female participants were recruited, divided into two groups: a group of patients with FM (FM, n\u2009=\u200915, M age \u2009=\u200951.87) and a healthy control group (HC) (HC, n\u2009=\u200915, M age \u2009=\u200946.13']",[],"['generalized attentional deficits', 'Emotional and Attentional Bias', 'larger P300 amplitudes']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}]",30.0,0.0428402,"The results did not show behavioral differences between groups, but the EEG results showed that healthy controls had larger P300 amplitudes than patients with FM.","[{'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Cardoso', 'Affiliation': 'Laboratory of Neuropsychophysiology, Faculty of Psychology and Education Sciences, University of Porto, Rua Alfredo Allen, 4200-135, Porto, Portugal. carmensnunes@utad.pt.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Fernandes', 'Affiliation': 'Laboratory of Neuropsychophysiology, Faculty of Psychology and Education Sciences, University of Porto, Rua Alfredo Allen, 4200-135, Porto, Portugal.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Barbosa', 'Affiliation': 'Laboratory of Neuropsychophysiology, Faculty of Psychology and Education Sciences, University of Porto, Rua Alfredo Allen, 4200-135, Porto, Portugal.'}]",Neurology and therapy,['10.1007/s40120-021-00287-8']
1036,34622310,Clinical study showing a lower abundance of Neisseria in the oral microbiome aligns with low birth weight pregnancy outcomes.,"OBJECTIVES


The objective of this study was to examine the association between the oral microbiome and pregnancy outcomes, specifically healthy or preterm low birth weight (PLBW) in individuals with and without periodontal disease (PD).
MATERIAL AND METHODS


In this prospective clinical trial, we recruited 186 pregnant women, 17 of whom exhibited PD and delivered PLBW infants (PD-PLBW group). Of the remaining women, 155 presented PD and delivered healthy infants; 18 of these subjects with similar periodontal condition and age matched to the PD-PLBW group, and they became the PD-HD group. From the total group, 11 women exhibited healthy gingiva and had a healthy delivery (HD) and healthy infants (H-HD group), and 3 exhibited healthy gingiva and delivered PLBW infants (H-PLBW group). Periodontal parameters were recorded, and subgingival plaque and serum were collected during 26-28 gestational weeks. For the plaque samples, microbial abundance and diversity were accessed by 16S rRNA sequencing.
RESULTS


Women with PD showed an enrichment in the genus Porphyromonas, Treponema, and Filifactor, whereas women with healthy gingiva showed an enrichment in Streptococcus, Actinomyces, and Corynebacterium, independently of the birth status. Although no significant difference was found in the beta diversity between the 4 groups, women that had PLBW infants presented a significantly lower abundance of the genus Neisseria, independently of PD status.
CONCLUSION


Lower levels of Neisseria align with preterm low birth weight in pregnant women, whereas a higher abundance of Treponema, Porphyromonas, Fretibacterium, and Filifactor and a lower abundance of Streptococcus may contribute to periodontal disease during pregnancy.
CLINICAL RELEVANCE


The oral commensal Neisseria have potential in the prediction of PLBW.",2022,"RESULTS


Women with PD showed an enrichment in the genus Porphyromonas, Treponema, and Filifactor, whereas women with healthy gingiva showed an enrichment in Streptococcus, Actinomyces, and Corynebacterium, independently of the birth status.","['pregnant women', '186 pregnant women, 17 of whom exhibited PD and delivered PLBW infants (PD-PLBW group', 'remaining women, 155 presented PD and delivered healthy infants; 18 of these subjects with similar periodontal condition and age matched to the PD-PLBW group, and they became the PD-HD group', '11 women exhibited healthy gingiva and had a healthy delivery (HD) and healthy infants (H-HD group), and 3 exhibited healthy gingiva and delivered PLBW infants (H-PLBW group', 'healthy or preterm low birth weight (PLBW) in individuals with and without periodontal disease (PD']",[],"['beta diversity', 'subgingival plaque and serum']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0021288', 'cui_str': 'Low birth weight infant'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0399451', 'cui_str': 'Subgingival plaque'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",186.0,0.0469921,"RESULTS


Women with PD showed an enrichment in the genus Porphyromonas, Treponema, and Filifactor, whereas women with healthy gingiva showed an enrichment in Streptococcus, Actinomyces, and Corynebacterium, independently of the birth status.","[{'ForeName': 'Changchang', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Periodontology, West China Hospital of Stomatology, Sichuan University, Renmin South Road 3rd section 14#, 610041, Chengdu, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'You', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Periodontology, West China Hospital of Stomatology, Sichuan University, Renmin South Road 3rd section 14#, 610041, Chengdu, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Periodontology, West China Hospital of Stomatology, Sichuan University, Renmin South Road 3rd section 14#, 610041, Chengdu, China.'}, {'ForeName': 'Zhongyi', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Periodontology, West China Hospital of Stomatology, Sichuan University, Renmin South Road 3rd section 14#, 610041, Chengdu, China.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Radaic', 'Affiliation': 'Department of Orofacial Sciences, Division of Periodontology, School of Dentistry, University of California San Francisco, Box 0422, UCSF, San Francisco, CA, 94143-0422, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Periodontology, West China Hospital of Stomatology, Sichuan University, Renmin South Road 3rd section 14#, 610041, Chengdu, China.'}, {'ForeName': 'Wanhong', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Periodontology, West China Hospital of Stomatology, Sichuan University, Renmin South Road 3rd section 14#, 610041, Chengdu, China.'}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Periodontology, West China Hospital of Stomatology, Sichuan University, Renmin South Road 3rd section 14#, 610041, Chengdu, China. yfw1110@163.com.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Kapila', 'Affiliation': 'Department of Orofacial Sciences, Division of Periodontology, School of Dentistry, University of California San Francisco, Box 0422, UCSF, San Francisco, CA, 94143-0422, USA. Yvonne.Kapila@ucsf.edu.'}]",Clinical oral investigations,['10.1007/s00784-021-04214-x']
1037,34622233,Blocking endogenous IL-6 impairs mobilization of free fatty acids during rest and exercise in lean and obese men.,"Lack of interleukin-6 (IL-6) leads to expansion of adipose tissue mass in rodents and humans. The exact underlying mechanisms have not been identified. In this placebo-controlled, non-randomized, participant-blinded crossover study, we use the IL-6 receptor antibody tocilizumab to investigate the role of endogenous IL-6 in regulating systemic energy metabolism at rest and during exercise and recovery in lean and obese men using tracer dilution methodology. Tocilizumab reduces fatty acid appearance in the circulation under all conditions in lean and obese individuals, whereas lipolysis (the rate of glycerol appearance into the circulation) is mostly unaffected. The fact that fatty acid oxidation is unaffected by IL-6 receptor blockade suggests increased re-esterification of fatty acids. Glucose kinetics are unaffected. We find that blocking endogenous IL-6 signaling with tocilizumab impairs fat mobilization, which may contribute to expansion of adipose tissue mass and, thus, affect the health of individuals undergoing anti-IL-6 therapy (Clinicaltrials.gov: NCT03967691).",2021,"Tocilizumab reduces fatty acid appearance in the circulation under all conditions in lean and obese individuals, whereas lipolysis (the rate of glycerol appearance into the circulation) is mostly unaffected.","['lean and obese individuals', 'lean and obese men', 'rodents and humans']","['tocilizumab', 'placebo', 'IL-6 receptor antibody tocilizumab', 'Tocilizumab']",['Glucose kinetics'],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0035804', 'cui_str': 'Order Rodentia'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",,0.281495,"Tocilizumab reduces fatty acid appearance in the circulation under all conditions in lean and obese individuals, whereas lipolysis (the rate of glycerol appearance into the circulation) is mostly unaffected.","[{'ForeName': 'Beckey', 'Initials': 'B', 'LastName': 'Trinh', 'Affiliation': 'The Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Merel', 'Initials': 'M', 'LastName': 'Peletier', 'Affiliation': 'The Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Simonsen', 'Affiliation': 'The Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Plomgaard', 'Affiliation': 'The Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'The Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Klarlund Pedersen', 'Affiliation': 'The Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'The Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Cell reports. Medicine,['10.1016/j.xcrm.2021.100396']
1038,34605699,"Evaluation of Afterschool Activity Programs' (ASAP) Effect on Children's Physical Activity, Physical Health, and Fundamental Movement Skills.","BACKGROUND


Physical literacy-focused afterschool activity programs (ASAPs) can be an effective strategy to improve children's health-related parameters. We sought to compare physical activity, body composition, aerobic capacity, and fundamental movement skills between physical literacy-focused ASAP and a standard recreational ASAP.
METHOD


A pre-post (6 months) comparison study was conducted in 5- to 12-year-old children in a physical literacy-focused ASAP (physical literacy group,  n  = 14) and children attending a standard recreational ASAP (comparison group,  n  = 15). Physical activity guideline adherence was assessed using accelerometry, body composition was analyzed using bioelectrical impedance, aerobic capacity was estimated using the Progressive Aerobic Cardiovascular Endurance Run test, and fundamental movement skills were evaluated using the Test of Gross Motor Development-2.
RESULTS


There were no significant differences between groups at baseline. After 6 months, the physical literacy group exhibited a significant improvement in their total raw score for the Test of Gross Motor Development-2 ( p  = .016), which was likely due to improvements in object control skills ( p  = .024). The comparison group significantly increased body mass index ( p  = .001) and body fat ( p  = .009) over time. No significant between-group differences were found; however, there was a trend for improved aerobic capacity in the physical literacy group ( d  = 0.58).
CONCLUSIONS


Engagement in the physical literacy-focused ASAP contributed to an attenuated increase in adiposity and an improvement in object control skills.",2022,The comparison group significantly increased body mass index ( p  = .001) and body fat ( p  = .009) over time.,"['A pre-post (6 months) comparison study was conducted in 5- to 12-year-old children in a physical literacy-focused ASAP (physical literacy group,  n  = 14) and children attending a standard recreational ASAP (comparison group,  n  = 15']","[""Afterschool Activity Programs' (ASAP"", 'Physical literacy-focused afterschool activity programs (ASAPs']","['aerobic capacity', 'object control skills', 'adiposity', 'Progressive Aerobic Cardiovascular Endurance Run test, and fundamental movement skills', 'Physical activity guideline adherence', 'body fat', 'total raw score', 'physical activity, body composition, aerobic capacity, and fundamental movement skills', 'body mass index', ""Children's Physical Activity, Physical Health, and Fundamental Movement Skills""]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1332353', 'cui_str': 'Atypical small acinar proliferation of prostate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1332353', 'cui_str': 'Atypical small acinar proliferation of prostate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0525059', 'cui_str': 'Guideline Adherence'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.00970317,The comparison group significantly increased body mass index ( p  = .001) and body fat ( p  = .009) over time.,"[{'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Crozier', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Niko S', 'Initials': 'NS', 'LastName': 'Wasenius', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Denize', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Danilo F', 'Initials': 'DF', 'LastName': 'da Silva', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Taniya S', 'Initials': 'TS', 'LastName': 'Nagpal', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kristi B', 'Initials': 'KB', 'LastName': 'Adamo', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/10901981211033234']
1039,34610387,Radiation Therapy Techniques and Treatment-Related Toxicity in the PORTEC-3 Trial: Comparison of 3-Dimensional Conformal Radiation Therapy Versus Intensity-Modulated Radiation Therapy.,"PURPOSE


Radiation therapy techniques have developed from 3-dimensional conformal radiation therapy (3DCRT) to intensity modulated radiation therapy (IMRT), with better sparing of the surrounding normal tissues. The current analysis aimed to investigate whether IMRT, compared to 3DCRT, resulted in fewer adverse events (AEs) and patient-reported symptoms in the randomized PORTEC-3 trial for high-risk endometrial cancer.
METHODS AND MATERIALS


Data on AEs and patient-reported quality of life (QoL) of the PORTEC-3 trial were available for analysis. Physician-reported AEs were graded using Common Terminology Criteria for Adverse Events v3.0. QoL was assessed by the European Organisation for Research and Treatment of Cancer QLQC30, CX24, and OV28 questionnaires. Data were compared between 3DCRT and IMRT. A P value of ≤ .01 was considered statistically significant due to the risk of multiple testing. For QoL, combined scores 1 to 2 (""not at all"" and ""a little"") versus 3 to 4 (""quite a bit"" and ""very much"") were compared between the techniques.
RESULTS


Of 658 evaluable patients, 559 received 3DCRT and 99 IMRT. Median follow-up was 74.6 months. During treatment no significant differences were observed, with a trend for more grade ≥3 AEs, mostly hematologic and gastrointestinal, after 3DCRT (37.7% vs 26.3%, P = .03). During follow-up, 15.4% (vs 4%) had grade ≥2 diarrhea, and 26.1% (vs 13.1%) had grade ≥2 hematologic AEs after 3DCRT (vs IMRT) (both P < .01). Among 574 (87%) patients evaluable for QoL, 494 received 3DCRT and 80 IMRT. During treatment, 37.5% (vs 28.6%) reported diarrhea after 3DCRT (vs IMRT) (P = .125); 22.1% (versus 10.0%) bowel urgency (P = 0039), and 18.2% and 8.6% abdominal cramps (P = .058). Other QoL scores showed no differences.
CONCLUSIONS


IMRT resulted in fewer grade ≥3 AEs during treatment and significantly lower rates of grade ≥2 diarrhea and hematologic AEs during follow-up. Trends toward fewer patient-reported bowel urgency and abdominal cramps were observed after IMRT compared to 3DCRT.",2022,Trends towards fewer patient-reported bowel urgency and abdominal cramps were observed after IMRT compared to 3DCRT.,"['658 evaluable patients', '574 (87%) patients evaluable for QoL, 494 received 3DCRT and 80 IMRT']","['Dimensional Conformal Radiotherapy versus Intensity-Modulated Radiotherapy', '3-dimensional conformal radiotherapy (3DCRT) to intensity-modulated radiotherapy (IMRT', 'IMRT', '3DCRT and 99 IMRT']","['quality of life (QoL', 'grade ≥3 AE, mostly hematological and gastro-intestinal', 'grade ≥2 diarrhea', 'grade ≥2 diarrhea and hematological AE', 'bowel urgency and abdominal cramps', 'QoL', 'diarrhea', 'grade ≥2 hematological AE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0426636', 'cui_str': 'Urgent desire for stool'}, {'cui': 'C0000729', 'cui_str': 'Abdominal Cramps'}]",658.0,0.124966,Trends towards fewer patient-reported bowel urgency and abdominal cramps were observed after IMRT compared to 3DCRT.,"[{'ForeName': 'Bastiaan G', 'Initials': 'BG', 'LastName': 'Wortman', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: b.g.wortman@lumc.nl.'}, {'ForeName': 'Cathalijne C B', 'Initials': 'CCB', 'LastName': 'Post', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Melanie E', 'Initials': 'ME', 'LastName': 'Powell', 'Affiliation': 'Department of Clinical Oncology, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Pearly', 'Initials': 'P', 'LastName': 'Khaw', 'Affiliation': 'Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Fyles', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Canada.'}, {'ForeName': 'Romerai', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Department of Radiotherapy, Azienda Socio Sanitaria Territoriale, Lecco, Italy.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Haie-Meder', 'Affiliation': 'Department of Radiotherapy, Institute Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Ina M', 'Initials': 'IM', 'LastName': 'Jürgenliemk-Schulz', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McCormack', 'Affiliation': 'Clinical Oncology, University College London Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Viet', 'Initials': 'V', 'LastName': 'Do', 'Affiliation': 'Radiation Oncology, Liverpool & Macarthur Cancer Therapy Center, NSW, Australia.'}, {'ForeName': 'Dionyssios', 'Initials': 'D', 'LastName': 'Katsaros', 'Affiliation': ""Department of Surgical Sciences, Gynecologic Oncology, Città della Salute and Sant'Anna Hospital, University of Turin, Turin, Italy.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bessette', 'Affiliation': 'Gynecologic Oncology, University of Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Marie Hélène', 'Initials': 'MH', 'LastName': 'Baron', 'Affiliation': 'Department of Radiotherapy, Centre Hospitalier Régional Universitaire de Besançon, Besançon, France.'}, {'ForeName': 'Remi A', 'Initials': 'RA', 'LastName': 'Nout', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Whitmarsh', 'Affiliation': 'The Clatterbridge Cancer Center, Bebington, United Kingdom.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mileshkin', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Ludy C H W', 'Initials': 'LCHW', 'LastName': 'Lutgens', 'Affiliation': 'Department of Radiation Oncology, MAASTRO, Maastricht, The Netherlands.'}, {'ForeName': 'Henry C', 'Initials': 'HC', 'LastName': 'Kitchener', 'Affiliation': 'Institute of Cancer Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Brooks', 'Affiliation': 'Department of Radiation Oncology, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Hans W', 'Initials': 'HW', 'LastName': 'Nijman', 'Affiliation': 'Department of Gynecologic Oncology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Eleftheria', 'Initials': 'E', 'LastName': 'Astreinidou', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Carien L', 'Initials': 'CL', 'LastName': 'Creutzberg', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'de Boer', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.09.042']
1040,34617916,Impact of a Mobile App on Paramedics' Perceived and Physiologic Stress Response During Simulated Prehospital Pediatric Cardiopulmonary Resuscitation: Study Nested Within a Multicenter Randomized Controlled Trial.,"BACKGROUND


Out-of-hospital cardiac arrests (OHCAs) are stressful, high-stake events that are associated with low survival rates. Acute stress experienced in this situation is associated with lower cardiopulmonary resuscitation performance in calculating drug dosages by emergency medical services. Children are particularly vulnerable to such errors. To date, no app has been validated to specifically support emergency drug preparation by paramedics through reducing the stress level of this procedure and medication errors.
OBJECTIVE


This study aims to determine the effectiveness of an evidence-based mobile app compared with that of the conventional preparation methods in reducing acute stress in paramedics at the psychological and physiological levels while safely preparing emergency drugs during simulated pediatric OHCA scenarios.
METHODS


In a parent, multicenter, randomized controlled trial of 14 emergency medical services, perceived and physiologic stress of advanced paramedics with drug preparation autonomy was assessed during a 20-minute, standardized, fully video-recorded, and highly realistic pediatric OHCA scenario in an 18-month-old child. The primary outcome was participants' self-reported psychological stress perceived during sequential preparations of 4 intravenous emergency drugs (epinephrine, midazolam, 10% dextrose, and sodium bicarbonate) with the support of the PedAMINES (Pediatric Accurate Medication in Emergency Situations) app designed to help pediatric drug preparation (intervention) or conventional methods (control). The State-Trait Anxiety Inventory and Visual Analog Scale questionnaires were used to measure perceived stress. The secondary outcome was physiologic stress, measured by a single continuous measurement of the participants' heart rate with optical photoplethysmography.
RESULTS


From September 3, 2019, to January 21, 2020, 150 advanced paramedics underwent randomization. A total of 74 participants were assigned to the mobile app (intervention group), and 76 did not use the app (control group). A total of 600 drug doses were prepared. Higher State-Trait Anxiety Inventory-perceived stress increase from baseline was observed during the scenario using the conventional methods (mean 35.4, SD 8.2 to mean 49.8, SD 13.2; a 41.3%, 35.0 increase) than when using the app (mean 36.1, SD 8.1 to mean 39.0, SD 8.4; a 12.3%, 29.0 increase). This revealed a 30.1% (95% CI 20.5%-39.8%; P<.001) lower relative change in stress response in participants who used the app. On the Visual Analog Scale questionnaire, participants in the control group reported a higher increase in stress at the peak of the scenario (mean 7.1, SD 1.8 vs mean 6.4, SD 1.9; difference: -0.8, 95% CI -1.3 to -0.2; P=.005). Increase in heart rate during the scenario and over the 4 drugs was not different between the 2 groups.
CONCLUSIONS


Compared with the conventional method, dedicated mobile apps can reduce acute perceived stress during the preparation of emergency drugs in the prehospital setting during critical situations. These findings can help advance the development and evaluation of mobile apps for OHCA management and should be encouraged.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03921346; https://clinicaltrials.gov/ct2/show/NCT03921346.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s13063-019-3726-4.",2021,"Compared with the conventional method, dedicated mobile apps can reduce acute perceived stress during the preparation of emergency drugs in the prehospital setting during critical situations.","['74 participants were assigned to the mobile app (intervention group), and 76 did not use the app (control group', 'From September 3, 2019, to January 21, 2020, 150 advanced paramedics underwent randomization', '14 emergency medical services, perceived and physiologic stress of advanced paramedics with drug preparation autonomy', 'paramedics at the psychological and physiological levels while safely preparing emergency drugs during simulated pediatric OHCA scenarios', 'Simulated Prehospital Pediatric Cardiopulmonary Resuscitation']","['epinephrine, midazolam, 10% dextrose, and sodium bicarbonate', 'Mobile App']","['stress response', 'heart rate', ""physiologic stress, measured by a single continuous measurement of the participants' heart rate with optical photoplethysmography"", 'cardiopulmonary resuscitation performance', ' self-reported psychological stress', 'Higher State-Trait Anxiety Inventory-perceived stress increase', 'acute stress', 'State-Trait Anxiety Inventory and Visual Analog Scale questionnaires', ""Paramedics' Perceived and Physiologic Stress Response"", 'Visual Analog Scale questionnaire', 'stress at the peak of the scenario']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0013164', 'cui_str': 'Drug Preparation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",74.0,0.281681,"Compared with the conventional method, dedicated mobile apps can reduce acute perceived stress during the preparation of emergency drugs in the prehospital setting during critical situations.","[{'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Lacour', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Bloudeau', 'Affiliation': 'A.C.E. Geneva Ambulances SA, Geneva, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Combescure', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haddad', 'Affiliation': ""Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Hugon', 'Affiliation': ""Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Suppan', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Rodieux', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lovis', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Gervaix', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Ehrler', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Manzano', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Johan N', 'Initials': 'JN', 'LastName': 'Siebert', 'Affiliation': 'University of Geneva, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""See Authors' Contributions, .""}]",JMIR mHealth and uHealth,['10.2196/31748']
1041,34614363,"Diet-dependent acid load is associated with mean arterial pressure in a cohort of non-obese, non-black, postmenopausal women.","Higher sodium (Na + ) intake is associated with higher blood pressure (BP). Whether this relationship is stronger with diet-dependent acid load (DAL) and in patients diagnosed with hypertension or normal BP is not well determined. We studied 170 postmenopausal women randomized to receive potassium bicarbonate or placebo for 36 months, after which 24-hour urine and arterialized blood samples were collected. We investigated the association between DAL estimated as urinary potential renal acid load (UPRAL) and mean arterial pressure (MAP) using a mixed-effects model, adjusting for age, anthropometrics, creatinine clearance, and treatment. Adjusted regression estimates for changes in Na +  and UPRAL on MAP after 12 months of follow-up were calculated, and further adjustments were made for changes in potassium (K + ) and body mass index (BMI). MAP was inversely associated with UPRAL (β [95% confidence interval]: -0.11 [-0.25, -0.001]). There was an effect modification by hypertension ( p -interaction = 0.04); MAP decreased significantly in normotensives, but the association was not significant in hypertensives. A decrease of 0.70 mm Hg in MAP [0.13, 1.69] per 50 mmol/24 hour reduction in Na +  was noted when the model was adjusted for change in K + . Our results with UPRAL exhibited a stronger dose-response for MAP, which remained significant after adjusting for BMI. UPRAL was independently associated with MAP even after adjusting for potential confounders, and the data showed that this association was more pronounced in normotensive patients.  Novelty:  First longitudinal study on the association of UPRAL and MAP. Association was a more robust relationship than that between U [Na + /K + ] ratio and MAP. UPRAL may play a significant role in the pathogenesis of primary hypertension.",2022,There was effect modification by hypertension (p-interaction=0.04); MAP decreased significantly in normotensives but the association was not significant in hypertensives.,"['170 postmenopausal women randomized to', 'patients with diagnosed hypertension or normal BP', 'cohort of non-obese, non-black, post-menopausal women']","['Diet-dependent acid load associates with mean arterial pressure', 'Higher sodium (Na+) intakes', 'potassium bicarbonate or placebo']","['hypertension', 'blood pressure (BP', 'change in potassium (K+) and body mass index (BMI', 'Novelty', 'Na', 'urinary potential renal acid load (UPRAL) and mean arterial pressure (MAP']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0595879', 'cui_str': 'Sodium high'}, {'cui': 'C0074752', 'cui_str': 'Sodium perchlorate'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0071751', 'cui_str': 'potassium bicarbonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",170.0,0.0308284,There was effect modification by hypertension (p-interaction=0.04); MAP decreased significantly in normotensives but the association was not significant in hypertensives.,"[{'ForeName': 'Tanushree', 'Initials': 'T', 'LastName': 'Banerjee', 'Affiliation': 'Department of Medicine, University of California, San Francisco, California, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Sebastian', 'Affiliation': 'Department of Medicine, University of California, San Francisco, California, USA.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Frassetto', 'Affiliation': 'Department of Medicine, University of California, San Francisco, California, USA.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0928']
1042,34618727,"Potential Value of Presepsin Guidance in Shortening Antibiotic Therapy in Septic Patients: a Multicenter, Prospective Cohort Trial.","INTRODUCTION


Long-term use of antibiotics for septic patients leads to bacterial resistance, increased mortality, and hospital stay. In this study, we investigated an emerging biomarker presepsin-guided strategy, which can be used to evaluate the shortening of antibiotic treatment in patients with sepsis without risking a worse outcome.
METHODS


In this multicenter prospective cohort trial, patients were assigned to the presepsin or control groups. In the presepsin group, antibiotics were ceased based on predefined cut-off ranges of presepsin concentrations. The control group stopped antibiotics according to international guidelines. The primary endpoints were the number of days without antibiotics within 28 days and mortality at 28 and 90 days. Secondary endpoints were the percentage of patients with a recurrent infection, length of stay in ICU and hospital, hospitalization costs, days of first episode of antibiotic treatment, percentage of antibiotic administration and multidrug-resistant bacteria, and SOFA score.
RESULTS


Overall, 656 out of an initial 708 patients were eligible and assigned to the presepsin group (n = 327) or the control group (n = 329). Patients in the presepsin group had significantly more days without antibiotics than those in the control group (14.54 days [SD 9.01] vs. 11.01 days [SD 7.73]; P < 0.001). Mortality in the presepsin group showed no difference to that in the control group at days 28 (17.7% vs. 18.2%; P = 0.868) and 90 (19.9% vs. 19.5%; P = 0.891). Patients in the presepsin group had a significantly shorter mean length of stay in the hospital and lower hospitalization costs than control subjects. There were no differences in the rate of recurrent infection and multidrug-resistant bacteria and the SOFA score tendency between the two groups.
CONCLUSIONS


Presepsin guidance has potential to shorten the duration of antibiotic treatment in patients with sepsis without risking worse outcomes of death, recurrent infection, and aggravation of organ failure.
TRIAL REGISTRATION


ChiCTR, ChiCTR1900024391. Registered 9 July 2019-Retrospectively registered, http://www.chictr.org.cn.",2022,"There were no differences in the rate of recurrent infection and multidrug-resistant bacteria and the SOFA score tendency between the two groups.
","['patients with sepsis without risking a worse outcome', 'patients with sepsis', '656 out of an initial 708 patients were eligible and assigned to the presepsin group (n\u200a=\u200a327) or the control group (n\u200a=\u200a329']","['Antibiotic Therapy', 'Presepsin Guidance']","['percentage of patients with a recurrent infection, length of stay in ICU and hospital, hospitalization costs, days of first episode of antibiotic treatment, percentage of antibiotic administration and multidrug-resistant bacteria, and SOFA score', 'rate of recurrent infection and multidrug-resistant bacteria and the SOFA score tendency', 'days without antibiotics', 'mean length of stay in the hospital and lower hospitalization costs', 'Mortality', 'number of days without antibiotics within 28\u200adays and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239998', 'cui_str': 'Recurrent infectious disease'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199779', 'cui_str': 'Administration of antibiotic'}, {'cui': 'C1444090', 'cui_str': 'Resistant bacteria'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",708.0,0.0495331,"There were no differences in the rate of recurrent infection and multidrug-resistant bacteria and the SOFA score tendency between the two groups.
","[{'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'EICU of Department of Emergency Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Guoxing', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'EICU of Department of Emergency Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'EICU of Department of Emergency Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Tan', 'Affiliation': 'EICU of Department of Emergency Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'EICU of Department of Emergency Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'EICU of Department of Emergency Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Meili', 'Initials': 'M', 'LastName': 'Duan', 'Affiliation': 'Department of Critical Care Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Deyuan', 'Initials': 'D', 'LastName': 'Zhi', 'Affiliation': 'Department of Critical Care Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ziren', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'EICU of Department of Emergency Medicine, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Hang', 'Affiliation': 'EICU of Department of Emergency Medicine, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'EICU of Department of Emergency Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'EICU of Department of Emergency Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Caijun', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'EICU of Department of Emergency Medicine, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Fengjie', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'EICU of Department of Emergency Medicine, Beijing Luhe Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'EICU of Department of Emergency Medicine, The Hospital of Shunyi District Beijing, China Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'EICU of Department of Emergency Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'EICU of Department of Emergency Medicine, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xinchao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'EICU of Department of Emergency Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'EICU of Department of Emergency Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Qi', 'Affiliation': 'Department of Infectious Disease, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Miaorong', 'Initials': 'M', 'LastName': 'Xie', 'Affiliation': 'EICU of Department of Emergency Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Chunsheng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'EICU of Department of Emergency Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}]","Shock (Augusta, Ga.)",['10.1097/SHK.0000000000001870']
1043,34618684,Phase IIa clinical trial of complement C3 inhibitor AMY-101 in adults with periodontal inflammation.,"BackgroundGingivitis and periodontitis are prevalent inflammatory diseases of the periodontal tissues. Current treatments are often ineffective or do not prevent disease recurrence. Uncontrolled complement activation and the resulting chronic gingival inflammation are hallmarks of periodontal diseases. We determined the efficacy and safety of a complement 3-targeted therapeutic, AMY-101, which was locally administered to adult patients with periodontal inflammation.MethodsThirty-two patients with gingival inflammation were enrolled in a randomized, placebo-controlled, double-blind, split-mouth phase IIa trial that followed a dose escalation study to select a safe and effective dose in an additional 8 patients. Half of the patient's mouth was randomly assigned to AMY-101 (0.1 mg/site) or placebo injections at sites of inflammation, administered on days 0, 7, and 14, and then evaluated for safety and efficacy outcomes on days 28, 60, and 90. The primary efficacy outcome was a change in gingival inflammation, measured by a modified gingival index (MGI), and secondary outcomes included changes in bleeding on probing (BOP), the amount of plaque, pocket depth, clinical attachment level, and gingival crevicular fluid levels of matrix metalloproteinases (MMPs) over 90 days.ResultsA once-weekly intragingival injection of AMY-101 for 3 weeks was safe and well tolerated in all participants and resulted in significant (P < 0.001) reductions in clinical indices measuring gingival inflammation (MGI and BOP). AMY-101 significantly (P < 0.05) reduced MMP-8 and MMP-9 levels, indicators of inflammatory tissue destruction. These therapeutic effects persisted for at least 3 months after treatment.ConclusionAMY-101 treatment resulted in a significant and sustainable reduction in gingival inflammation without adverse events and, we believe, merits further investigation for the treatment of periodontitis and other oral or peri-implant inflammatory conditions.Trial registrationClinicalTrials.gov identifier NCT03694444.FundingAmyndas Pharmaceuticals.",2021,"AMY-101 significantly (P<0.05) reduced MMP-8 and MMP-9 levels, indicators of inflammatory tissue destruction.","['adults with periodontal inflammation', 'Thirty-two patients with gingival inflammation']","['complement C3 inhibitor AMY-101', 'placebo']","['safety and efficacy outcomes', 'clinical indices measuring gingival inflammation (MGI and BOP', 'MMP-8 and MMP-9 levels, indicators of inflammatory tissue destruction', 'safe and well-tolerated', 'efficacy and safety', 'change in gingival inflammation, measured by modified gingival index (MGI), and secondary outcomes included changes in bleeding-on-probing (BOP), amount of plaque, pocket depth, clinical attachment level, and gingival crevicular fluid levels of matrix metalloproteinases (MMPs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3495798', 'cui_str': 'Periodontal inflammation'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}]","[{'cui': 'C0009506', 'cui_str': 'Complement component C3'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}]",32.0,0.285023,"AMY-101 significantly (P<0.05) reduced MMP-8 and MMP-9 levels, indicators of inflammatory tissue destruction.","[{'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Hasturk', 'Affiliation': 'The Forsyth Institute, Center for Clinical and Translational Research (CCTR), Cambridge, Massachusetts, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hajishengallis', 'Affiliation': 'Department of Basic and Translational Sciences, University of Pennsylvania, Penn Dental Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Lambris', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Dimitrios C', 'Initials': 'DC', 'LastName': 'Mastellos', 'Affiliation': ""National Center for Scientific Research 'Demokritos,' Division of Biodiagnostic Science and Technologies, INRASTES, Athens, Greece.""}, {'ForeName': 'Despina', 'Initials': 'D', 'LastName': 'Yancopoulou', 'Affiliation': 'Amyndas Pharmaceuticals, Glyfada, Greece.'}]",The Journal of clinical investigation,['10.1172/JCI152973']
1044,34608713,Ultrasound-versus landmark-guided medium-sized joint arthrocentesis: A randomized clinical trial.,"OBJECTIVES


Arthrocentesis is commonly performed in the emergency department, but success rates vary based on location. Presently, there is a paucity of data assessing the utility of ultrasound-guided (USG) medium-sized joint arthrocentesis. The objective of this study was to compare the success of USG and landmark-guided (LMG) medium-sized joint arthrocentesis.
METHODS


This was a single-center, prospective, randomized clinical trial (NCT03327584) of a convenience sample of adult patients who presented to an urban, university hospital with > 105,000 visits annually. Patients with a suspected medium-sized joint effusion (defined as elbow, wrist, or ankle) undergoing arthrocentesis were randomized into LMG or USG using the GE Logiq e linear transducer (4-10 MHz). The following patients were excluded: on anticoagulation, with soft tissue infection overlying the joint, or involving an artificial joint. Statistical analysis included the Fisher exact, Mann-Whitney U-test, and t-test.
RESULTS


Overall, 44 patients were enrolled with 23 patients randomized into the LMG group and 21 patients into the USG arm. USG was significantly better than LMG with an overall success of 94.1% versus 60% for LMG (difference = 34.1%, 95% confidence interval [CI] = 4.90 to 58.83). USG first-pass success was 82.4% versus 46.7% for LMG (difference = 35.7%, 95% CI = 2.76 to 60.37) and a mean of 1.35 attempts versus 2.00 for LMG (difference = 0.65, 95% CI = 0.005 to 1.296). Of the 14 LMG failures, eight had no effusion present on USG crossover. Four patients in the USG group had no effusion present.
CONCLUSIONS


Ultrasound guidance improved first-pass and overall successful arthrocentesis of medium-sized joint effusions.",2022,"USG was significantly better than LMG with an overall success of 94.1% vs 60% for LMG (difference of 34.1%, 95% CI 4.90 - 58.83).","['Patients with a suspected medium sized joint effusion (defined as elbow, wrist, or ankle) undergoing arthrocentesis', '4 patients in the USG group had no effusion present', 'adult patients who presented to an urban, university hospital with >105,000 visits annually', '44 patients were enrolled with 23 patients randomized into the', 'patients were excluded: on anticoagulation, with soft tissue infection overlying the joint, or involving an artificial joint']","['LMG', 'Ultrasound vs Landmark Guided Medium Sized Joint Arthrocentesis', 'LMG or USG', 'ultrasound guided (USG) and landmark guided (LMG) medium sized joint arthrocentesis']",['USG first pass success'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1253936', 'cui_str': 'Effusion of joint'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0204854', 'cui_str': 'Arthrocentesis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0149778', 'cui_str': 'Soft tissue infection'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0204854', 'cui_str': 'Arthrocentesis'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0444693', 'cui_str': 'First pass'}]",44.0,0.157908,"USG was significantly better than LMG with an overall success of 94.1% vs 60% for LMG (difference of 34.1%, 95% CI 4.90 - 58.83).","[{'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Gibbons', 'Affiliation': 'Department of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Zanaboni', 'Affiliation': ""Department of Emergency Medicine, SSM St. Mary's Hospital, St. Louis, Missouri, USA.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Genninger', 'Affiliation': 'Department of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Costantino', 'Affiliation': 'Department of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14396']
1045,34607196,"Neuroaspis PLP10™, a nutritional formula rich in omega-3 and omega-6 fatty acids with antioxidant vitamins including gamma-tocopherol in early Parkinson's disease: A randomized, double-blind, placebo-controlled trial.","In the present study, we investigated whether Neuroaspis PLP10™, a well-designed intervention, rich in omega-3 (n-3) and omega-6 (n-6) polyunsaturated fatty acids (PUFAs) with specific antioxidant vitamins, may exert positive action in the improvement of Parkinson's disease symptoms and perhaps delay the progression of the disease when used as an adjuvant to the conventional treatment. Forty patients were randomized 1:1 to receive either 20 ml dose, once daily, of control (pure virgin olive oil) or Neuroaspis PLP 10™, a formula containing a mixture of omega-3 (810 mg Eicosapentaenoic acid and 4140 mg Docosahexaenoic acid) and omega-6 fatty acids (1800 mg gamma-Linolenic acid and 3150 mg Linoleic acid) (1:1 w/w), with 0.6 mg vitamin A, vitamin E (22 mg) plus pure gamma (γ)-tocopherol (760 mg), for a total of 30 months in a randomized double-blind, placebo-controlled trial. Participants completed assessments based on the Hoehn and Yahr Staging Scale of Parkinson's Disease (HY scale) and the Unified Parkinson's Disease Rating Scale (UPDRS) III. Overall, for this small sample size clinical trial, Neuroaspis PLP10™ supplementation as an adjuvant treatment for 30 months in PD patients significantly delayed disease progression according to UPDRS (p ≤ 0.05) Vs placebo.",2021,Participants completed assessments based on the Hoehn and Yahr Staging Scale of Parkinson's Disease (HY scale) and the Unified Parkinson's Disease Rating Scale (UPDRS) III.,"[""early Parkinson's disease"", 'Forty patients']","['control (pure virgin olive oil) or Neuroaspis PLP 10™, a formula containing a mixture of omega-3 (810\xa0mg Eicosapentaenoic acid and 4140', 'mg\xa0gamma-Linolenic acid and 3150', 'mg Linoleic acid', 'vitamin A, vitamin E (22\xa0mg) plus pure gamma (γ)-tocopherol', 'Neuroaspis PLP10™, a well-designed intervention, rich in omega-3 (n-3) and omega-6 (n-6) polyunsaturated fatty acids (PUFAs) with specific antioxidant vitamins', 'nutritional formula rich in omega-3 and omega-6 fatty acids with antioxidant vitamins', 'mg Docosahexaenoic acid) and omega-6 fatty acids', 'placebo']","['delayed disease progression', ""Hoehn and Yahr Staging Scale of Parkinson's Disease (HY scale) and the Unified Parkinson's Disease Rating Scale (UPDRS) III""]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0034266', 'cui_str': 'pyridoxal phosphate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0017054', 'cui_str': 'Gamma tocopherol'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0133860', 'cui_str': 'Fatty Acids, Omega-6'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}]",40.0,0.839737,Participants completed assessments based on the Hoehn and Yahr Staging Scale of Parkinson's Disease (HY scale) and the Unified Parkinson's Disease Rating Scale (UPDRS) III.,"[{'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Pantzaris', 'Affiliation': 'Cyprus Institute of Neurology and Genetics, Nicosia, Cyprus; School of Molecular Medicine, Cyprus Institute of Neurology and Genetics, Cyprus; PALUPA Medical Ltd, Nicosia, Cyprus. Electronic address: pantzari@cing.ac.cy.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loukaides', 'Affiliation': 'Cyprus Institute of Neurology and Genetics, Nicosia, Cyprus; PALUPA Medical Ltd, Nicosia, Cyprus.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Paraskevis', 'Affiliation': 'School of Medicine, European University Cyprus, Cyprus; Department of Hygiene Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Evangelia-Georgia', 'Initials': 'EG', 'LastName': 'Kostaki', 'Affiliation': 'Department of Hygiene Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Patrikios', 'Affiliation': 'School of Medicine, European University Cyprus, Cyprus; PALUPA Medical Ltd, Nicosia, Cyprus. Electronic address: i.patrikios@euc.ac.cy.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2021.106954']
1046,34613578,Autologous platelet-rich plasma treatment for moderate-severe Asherman syndrome: the first experience.,"PURPOSE


Treatment of Asherman syndrome (AS) presents a significant clinical challenge. Based on our in vitro data showing that PRP could activate endometrial cell proliferation and migration, we hypothesized that intrauterine infusion of autologous platelet-rich plasma (PRP) may improve endometrial regeneration and fertility outcomes in patients with moderate-severe AS.
MATERIALS AND METHODS


Subjects with moderate-severe AS were randomized to PRP or saline control administered following hysteroscopic adhesiolysis. Due to relative inability to randomize patients to the control group, after initial randomization of 10 subjects (6 in PRP and 4 in control groups), the remainder were prospectively enrolled in PRP group (n = 9), with 11 historic controls added to control group, for a total of 30 subjects (PRP n = 15; saline control n = 15). Right after hysteroscopy, 0.5-1 mL of PRP or saline was infused into the uterus via a Wallace catheter, followed by estrogen therapy. The primary outcomes were changes in endometrial thickness (EMT, checked in 3 weeks) and in menstrual flow; secondary outcomes were pregnancy and live birth rates. EMT and menstrual bleeding pattern were assessed before and after the intervention. Pregnancy was assessed over a 6-month period.
RESULTS


There were no statistically significant differences in age, gravidity/parity, cause of AS, preoperative menses assessment, AS hysteroscopy score, and intrauterine balloon placement between the groups. There was no statistically significant difference (p = 0.79) in EMT pre-PRP infusion for control (5.7 mm, 4.0-6.0) and study arm (5.3 mm, 4.9-6.0). There was no statistically significant change (p = 0.78) in EMT after PRP infusion (1.4 mm, - 0.5-2.4) vs saline (1.0 mm, 0.0-2.5). Patients tolerated the procedure well, with no adverse effects. There was no difference in the predicted likelihood of pregnancy (p = 0.45) between the control (0.67, 0.41-0.85) and study arm (0.53, 0.29-0.76).
CONCLUSIONS


PRP was well accepted and tolerated in AS patients. However, we did not observe any significant EMT increase or improved pregnancy rates after adding PRP infusion, compared to standard treatment only. The use of intrauterine PRP infusion may be a feasible option, and its potential use must be tested on a larger sample size of AS patients.",2021,"However, we did not observe any significant EMT increase or improved pregnancy rates after adding PRP infusion, compared to standard treatment only.","['Asherman syndrome (AS', '10 subjects (6 in PRP and 4 in control groups), the remainder were prospectively enrolled in PRP group (n\u2009=\u20099), with 11 historic controls added to control group, for a total of 30 subjects ', 'moderate-severe Asherman syndrome', 'patients with moderate-severe AS', 'Subjects with moderate-severe AS']","['PRP or saline control administered following hysteroscopic adhesiolysis', 'intrauterine PRP infusion', 'PRP or saline', 'Autologous platelet-rich plasma treatment', 'PRP n\u2009=\u200915; saline control n\u2009=\u200915']","['pregnancy rates', 'EMT and menstrual bleeding pattern', 'endometrial regeneration and fertility outcomes', 'changes in endometrial thickness (EMT, checked in 3\xa0weeks) and in menstrual flow; secondary outcomes were pregnancy and live birth rates', 'age, gravidity/parity, cause of AS, preoperative menses assessment, AS hysteroscopy score, and intrauterine balloon placement', 'predicted likelihood of pregnancy']","[{'cui': 'C0156372', 'cui_str': 'Asherman syndrome'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0012826', 'cui_str': 'Lysis of adhesions'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0156372', 'cui_str': 'Asherman syndrome'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0181374', 'cui_str': 'Intrauterine balloon'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",30.0,0.0306438,"However, we did not observe any significant EMT increase or improved pregnancy rates after adding PRP infusion, compared to standard treatment only.","[{'ForeName': 'Lusine', 'Initials': 'L', 'LastName': 'Aghajanova', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA. aghajano@stanford.edu.'}, {'ForeName': 'Viji', 'Initials': 'V', 'LastName': 'Sundaram', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Chia-Ning', 'Initials': 'CN', 'LastName': 'Kao', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Letourneau', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Evelyna', 'Initials': 'E', 'LastName': 'Manvelyan', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Marcelle I', 'Initials': 'MI', 'LastName': 'Cedars', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Heather G', 'Initials': 'HG', 'LastName': 'Huddleston', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-021-02328-5']
1047,34613454,Disease-modifying effects of ranibizumab for central retinal vein occlusion.,"PURPOSE


To identify anatomic endpoints altered by intravitreal ranibizumab in central retinal vein occlusion (CRVO) to determine any potential underlying disease modification that occurs with anti-vascular endothelial growth factor (anti-VEGF) therapy beyond best-corrected visual acuity and central optical coherence tomography outcomes.
METHODS


A post hoc analysis of a double-masked, multicenter, randomized clinical trial was performed. A total of 392 patients with macular edema after CRVO were randomized 1:1:1 to receive monthly intraocular injections of 0.3 or 0.5 mg of ranibizumab or sham injections. Central reading center-read data were reviewed to explore potential anatomic endpoints altered by therapy.
RESULTS


At 6 months, there was a reduction in the ranibizumab groups compared with sham groups with respect to total area of retinal hemorrhage (median change from baseline in disc areas: - 1.17 [sham], - 2.37 [ranibizumab 0.3 mg], - 1.64 [ranibizumab 0.5 mg]), development of disc neovascularization (prevalence: 3% [sham], 0% [ranibizumab 0.3 mg], 0% [ranibizumab 0.5 mg]), and presence of papillary swelling (prevalence: 22.9% [sham], 8.0% [ranibizumab 0.3 mg], 8.3% [ranibizumab 0.5 mg], p < 0.01). There was no difference between groups in collateral vessel formation. Analysis of vitreous and preretinal hemorrhage could not be performed due to low frequency of events in both treated and sham groups.
CONCLUSIONS


Ranibizumab for CRVO resulted in beneficial disease-modifying effects through a reduction in retinal hemorrhage, neovascularization, and papillary swelling. These findings may form the basis for future work in the development of a treatment response or severity scale for eyes with CRVO.",2022,"At 6 months, there was a reduction in the ranibizumab groups compared with sham groups with respect to total area of retinal hemorrhage (median change from baseline in disc areas: - 1.17 [sham], - 2.37 [ranibizumab 0.3 mg], - 1.64 [ranibizumab 0.5 mg]), development of disc neovascularization (prevalence: 3% [sham], 0% [ranibizumab 0.3 mg], 0% [ranibizumab 0.5 mg]), and presence of papillary swelling (prevalence: 22.9% [sham], 8.0% [ranibizumab 0.3 mg], 8.3% [ranibizumab 0.5 mg], p < 0.01).","['central retinal vein occlusion (CRVO', 'central retinal vein occlusion', '392 patients with macular edema after CRVO']","['ranibizumab', 'Ranibizumab', 'monthly intraocular injections of 0.3 or 0.5\xa0mg of ranibizumab or sham injections', 'ranibizumab 0.3\xa0mg], 8.3% [ranibizumab', 'intravitreal ranibizumab']","['total area of retinal hemorrhage', 'development of disc neovascularization', 'retinal hemorrhage, neovascularization, and papillary swelling', 'collateral vessel formation']","[{'cui': 'C0154841', 'cui_str': 'Central retinal vein occlusion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1554875', 'cui_str': 'Intra-ocular injection'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035317', 'cui_str': 'Retinal hemorrhage'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1112634', 'cui_str': 'Disc neovascularization'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C1275670', 'cui_str': 'Collateral branch of vessel'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",392.0,0.586155,"At 6 months, there was a reduction in the ranibizumab groups compared with sham groups with respect to total area of retinal hemorrhage (median change from baseline in disc areas: - 1.17 [sham], - 2.37 [ranibizumab 0.3 mg], - 1.64 [ranibizumab 0.5 mg]), development of disc neovascularization (prevalence: 3% [sham], 0% [ranibizumab 0.3 mg], 0% [ranibizumab 0.5 mg]), and presence of papillary swelling (prevalence: 22.9% [sham], 8.0% [ranibizumab 0.3 mg], 8.3% [ranibizumab 0.5 mg], p < 0.01).","[{'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Huang', 'Affiliation': 'University of California Los Angeles Stein Eye Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, CA, USA.'}, {'ForeName': 'Avanti', 'Initials': 'A', 'LastName': 'Ghanekar', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Pin-Wen', 'Initials': 'PW', 'LastName': 'Wang', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Bann-Mo', 'Initials': 'BM', 'LastName': 'Day', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Blodi', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Amitha', 'Initials': 'A', 'LastName': 'Domalpally', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Quezada-Ruiz', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ip', 'Affiliation': 'Doheny Eye Institute, 800 South Fairmont Avenue, Pasadena, CA, 91105, USA. mip@doheny.org.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-021-05224-x']
1048,34612491,Effectiveness of unconditional cash transfers combined with lipid-based nutrient supplement and/or behavior change communication to prevent stunting among children in Pakistan: a cluster randomized controlled trial.,"BACKGROUND


In Pakistan, the prevalence of stunting among children younger than 5 y has remained above WHO critical thresholds (≥30%) over the past 2 decades.
OBJECTIVES


We hypothesized that an unconditional cash transfer (UCT) combined with lipid-based nutrient supplement (LNS) and/or social and behavior change communication (SBCC) will prevent stunting among children 6-23 mo of age.
METHODS


This was a 4-arm, community-based cluster randomized controlled trial conducted in the district of Rahim Yar Khan, Pakistan. A total of 1729 children (UCT, n = 434; UCT + SBCC, n = 433; UCT + LNS, n = 430; and UCT + LNS + SBCC, n = 432) were enrolled at 6 mo of age and measured monthly for 18 mo until the age of 24 mo.
RESULTS


At 24 mo of age, children who received UCT + LNS [rate ratio (RR): 0.85; 95% CI: 0.74, 0.97; P = 0.015) and UCT + LNS + SBCC (RR: 0.86; 95% CI: 0.77, 0.96; P = 0.007) had a significantly lower risk of being stunted compared with the UCT arm. No significant difference was noted among children who received UCT + SBCC (RR: 1.03; 95% CI: 0.91, 1.16; P = 0.675) in the risk of being stunted compared with the UCT arm. The pooled prevalence of stunting among children aged 6-23 mo was 41.7%, 44.8%, 38.5%, and 39.3% in UCT, UCT + SBCC, UCT + LNS, and UCT + LNS + SBCC, respectively. In pairwise comparisons, a significant impact on stunting among children in UCT + LNS (P = 0.029) and UCT + LNS + SBCC (P = <0.001) was noted compared with the UCT arm.
CONCLUSIONS


UCT combined with LNS and UCT + LNS + SBCC were effective in reducing the prevalence of stunting among children aged 6-23 mo in marginalized populations. UCT + SBCC was not effective in reducing the child stunting prevalence. This trial was registered at clinicaltrials.gov as NCT03299218.",2022,"The pooled prevalence of stunting among children 6-23 months was 41.7%, 44.8%, 38.5% and 39.3% in UCT, UCT+SBCC, UCT+LNS and UCT+LNS+SBCC, respectively.","['children 6-23 months of age', 'district of Rahim Yar Khan, Pakistan', '1729 children (UCT n = 434); (UCT+SBCC n = 433); (UCT+LNS n = 430) and (UCT+LNS+SBCC n = 432) were enrolled at 6 months of age and measured monthly for 18 months until the age of 24 months', 'stunting among children in Pakistan']","['UCT combined with LNS and UCT+LNS+SBCC', 'UCT+SBCC', 'unconditional cash transfer (UCT) combined with lipid-based nutrient supplement (LNS) and/or social and behavior change communication (SBCC', 'unconditional cash transfers combined with lipid-based nutrient supplement and/or behavior change communication']",['prevalence of stunting'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0041497', 'cui_str': 'Tyrosine-tRNA ligase'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}]",1729.0,0.220737,"The pooled prevalence of stunting among children 6-23 months was 41.7%, 44.8%, 38.5% and 39.3% in UCT, UCT+SBCC, UCT+LNS and UCT+LNS+SBCC, respectively.","[{'ForeName': 'Sajid Bashir', 'Initials': 'SB', 'LastName': 'Soofi', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Shabina', 'Initials': 'S', 'LastName': 'Ariff', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Gul Nawaz', 'Initials': 'GN', 'LastName': 'Khan', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Habib', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sumra', 'Initials': 'S', 'LastName': 'Kureishy', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Ihtesham', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Masawar', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Centre of Excellence in Women and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Arjumand', 'Initials': 'A', 'LastName': 'Rizvi', 'Affiliation': 'Centre of Excellence in Women and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Sajid', 'Affiliation': 'Centre of Excellence in Women and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Akbar', 'Affiliation': 'Benazir Income Support Programme, Government of Pakistan, Islamabad, Pakistan.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Garzon', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'de Pee', 'Affiliation': 'World Food Programme, Rome, Italy.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre of Excellence in Women and Child Health, Aga Khan University, Karachi, Pakistan.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab341']
1049,34617922,Impact of endotracheal tube taping site on tube displacement during head movements: A prospective randomised controlled study.,,2021,,['tube displacement during head movements'],['endotracheal tube taping site'],[],"[{'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0376591', 'cui_str': 'Head Movements'}]","[{'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",[],,0.0127694,,"[{'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Ortais', 'Affiliation': 'From the VIVALTO clinic, Medico-Surgical Center of the Bay of Morlaix, Morlaix (GO), Department of Pneumology (CG-G), INSERM CIC 1412 (ZA), Departments of Anaesthesia and Intensive Care, University Hospital of Brest (GO, B-VN), Department of Anesthesia and Intensive Care, Laveran Military Teaching Hospital, Marseille; French Military Health Service Academy, Ecole du Val-de-Grâce, Paris, France (B-VN).'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Gut-Gobert', 'Affiliation': ''}, {'ForeName': 'Zarrin', 'Initials': 'Z', 'LastName': 'Alavi', 'Affiliation': ''}, {'ForeName': 'Ba-Vinh', 'Initials': 'BV', 'LastName': 'Nguyen', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001517']
1050,34619638,Early Biomarkers of Hypoxia and Inflammation and Two-Year Neurodevelopmental Outcomes in the Preterm Erythropoietin Neuroprotection (PENUT) Trial.,"BACKGROUND


In the Preterm Erythropoietin (Epo) NeUroproTection (PENUT) Trial, potential biomarkers of neurological injury were measured to determine their association with outcomes at two years of age and whether Epo treatment decreased markers of inflammation in extremely preterm (<28 weeks' gestation) infants.
METHODS


Plasma Epo was measured (n=391 Epo, n=384 placebo) within 24h after birth (baseline), 30min after study drug administration (day 7), 30min before study drug (day 9), and on day 14. A subset of infants (n=113 Epo, n=107 placebo) had interferon-gamma (IFN-γ), Interleukin (IL)-6, IL-8, IL-10, Tau, and tumour necrosis factor-α (TNF-α) levels evaluated at baseline, day 7 and 14. Infants were then evaluated at 2 years using the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III).
FINDINGS


Elevated baseline Epo was associated with increased risk of death or severe disability (BSID-III Motor and Cognitive subscales <70 or severe cerebral palsy). No difference in other biomarkers were seen between treatment groups at any time, though Epo appeared to mitigate the association between elevated baseline IL-6 and lower BSID-III scores in survivors. Elevated baseline, day 7 and 14 Tau concentrations were associated with worse BSID-III Cognitive, Motor, and Language skills at two years.
INTERPRETATION


Elevated Epo at baseline and elevated Tau in the first two weeks after birth predict poor outcomes in infants born extremely preterm. However, no clear prognostic cut-off values are apparent, and further work is required before these biomarkers can be widely implemented in clinical practice.
FUNDING


PENUT was funded by the National Institute of Neurological Disorders and Stroke (U01NS077955 and U01NS077953).",2021,"Elevated baseline, day 7 and 14 Tau concentrations were associated with worse BSID-III Cognitive, Motor, and Language skills at two years.
",[],['factor-α'],"['TNF-α) levels', 'elevated baseline IL-6 and lower BSID-III scores', 'worse BSID-III Cognitive, Motor, and Language skills', 'interferon-gamma (IFN-γ), Interleukin (IL)-6, IL-8, IL-10, Tau, and tumour necrosis', 'risk of death or severe disability (BSID-III Motor and Cognitive subscales <70 or severe cerebral palsy']",[],[],"[{'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0333516', 'cui_str': 'Tumor necrosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]",,0.603734,"Elevated baseline, day 7 and 14 Tau concentrations were associated with worse BSID-III Cognitive, Motor, and Language skills at two years.
","[{'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Wood', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Washington, Seattle, WA.'}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Parikh', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Washington, Seattle, WA.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Comstock', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Janessa B', 'Initials': 'JB', 'LastName': 'Law', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Washington, Seattle, WA.'}, {'ForeName': 'Theo K', 'Initials': 'TK', 'LastName': 'Bammler', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, WA.'}, {'ForeName': 'Karl C', 'Initials': 'KC', 'LastName': 'Kuban', 'Affiliation': 'Department of Pediatrics, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Mayock', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Washington, Seattle, WA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Juul', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Washington, Seattle, WA. Electronic address: sjuul@uw.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EBioMedicine,['10.1016/j.ebiom.2021.103605']
1051,34623633,Ketamine and other glutamate receptor modulators for depression in adults with bipolar disorder.,"BACKGROUND


Glutamergic system dysfunction has been implicated in the pathophysiology of bipolar depression. This is an update of the 2015 Cochrane Review for the use of glutamate receptor modulators for depression in bipolar disorder.
OBJECTIVES


1. To assess the effects of ketamine and other glutamate receptor modulators in alleviating the acute symptoms of depression in people with bipolar disorder. 2. To review the acceptability of ketamine and other glutamate receptor modulators in people with bipolar disorder who are experiencing depressive symptoms.
SEARCH METHODS


We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Embase and PsycINFO all years to July 2020.  We did not apply any restrictions to date, language or publication status.
SELECTION CRITERIA


RCTs comparing ketamine or other glutamate receptor modulators with other active psychotropic drugs or saline placebo in adults with bipolar depression.
DATA COLLECTION AND ANALYSIS


Two review authors independently selected studies for inclusion, assessed trial quality and extracted data. Primary outcomes were response rate and adverse events. Secondary outcomes included remission rate, depression severity change scores, suicidality, cognition, quality of life, and dropout rate. The GRADE framework was used to assess the certainty of the evidence.
MAIN RESULTS


Ten studies (647 participants) were included in this review (an additional five studies compared to the 2015 review). There were no additional studies added to the comparisons identified in the 2015 Cochrane review on ketamine, memantine and cytidine versus placebo. However, three new comparisons were found: ketamine versus midazolam, N-acetylcysteine versus placebo, and riluzole versus placebo. The glutamate receptor modulators studied were ketamine (three trials), memantine (two), cytidine (one), N-acetylcysteine (three), and riluzole (one). Eight of these studies were placebo-controlled and two-armed. In seven trials the glutamate receptor modulators had been used as add-on drugs to mood stabilisers. Only one trial compared ketamine with an active comparator, midazolam. The treatment period ranged from a single intravenous administration (all ketamine studies), to repeated administration for riluzole, memantine, cytidine, and N-acetylcysteine (with a follow-up of eight weeks, 8 to 12 weeks, 12 weeks, and 16 to 20 weeks, respectively). Six of the studies included sites in the USA, one in Taiwan, one in Denmark, one in Australia, and in one study the location was unclear. All participants had a primary diagnosis of bipolar disorder and were experiencing an acute bipolar depressive episode, diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders fourth edition (IV) or fourth edition text revision (IV-TR). Among all glutamate receptor modulators included in this review, only ketamine appeared to be more efficacious than placebo 24 hours after infusion for response rate (odds ratio (OR) 11.61, 95% confidence interval (CI) 1.25 to 107.74; P = 0.03; participants = 33; studies = 2; I² = 0%, low-certainty evidence). Ketamine seemed to be more effective in reducing depression rating scale scores (MD -11.81, 95% CI -20.01 to -3.61; P = 0.005; participants = 32; studies = 2; I 2  = 0%, very low-certainty evidence). There was no evidence of ketamine's efficacy in producing remission over placebo at 24 hours (OR 5.16, 95% CI 0.51 to 52.30; P = 0.72; participants = 33; studies = 2; I 2  = 0%, very low-certainty evidence). Evidence on response, remission or depression rating scale scores between ketamine and midazolam was uncertain at 24 hours due to very low-certainty evidence (OR 3.20, 95% CI 0.23 to 45.19). In the one trial assessing ketamine and midazolam, there were no dropouts due to adverse effects or for any reason (very low-certainty evidence). Placebo may have been more effective than N-acetylcysteine in reducing depression rating scale scores at three months, although this was based on very low-certainty evidence (MD 1.28, 95% CI 0.24 to 2.31; participants = 58; studies = 2). Very uncertain evidence found no difference in response at three months (OR 0.82, 95% CI 0.32 to 2.14; participants = 69; studies = 2; very low-certainty evidence). No data were available for remission or acceptability. Extremely limited data were available for riluzole vs placebo, finding only very-low certainty evidence of no difference in dropout rates (OR 2.00, 95% CI 0.31 to 12.84; P = 0.46; participants = 19; studies = 1; I 2  = 0%).
AUTHORS' CONCLUSIONS


It is difficult to draw reliable conclusions from this review due to the certainty of the evidence being low to very low, and the relatively small amount of data usable for analysis in bipolar disorder, which is considerably less than the information available for unipolar depression. Nevertheless, we found uncertain evidence in favour of a single intravenous dose of ketamine (as add-on therapy to mood stabilisers) over placebo in terms of response rate up to 24 hours, however ketamine did not show any better efficacy for remission in bipolar depression. Even though ketamine has the potential to have a rapid and transient antidepressant effect, the efficacy of a single intravenous dose may be limited. We did not find conclusive evidence on adverse events with ketamine, and there was insufficient evidence to draw meaningful conclusions for the remaining glutamate receptor modulators. However, ketamine's psychotomimetic effects (such as delusions or delirium) may have compromised study blinding in some studies, and so we cannot rule out the potential bias introduced by inadequate blinding procedures. To draw more robust conclusions, further methodologically sound RCTs (with adequate blinding) are needed to explore different modes of administration of ketamine, and to study different methods of sustaining antidepressant response, such as repeated administrations.",2021,"Ketamine seemed to be more effective in reducing depression rating scale scores (MD -11.81, 95% CI -20.01 to -3.61; P = 0.005; participants = 32; studies = 2; I 2  = 0%, very low-certainty evidence).","['All participants had a primary diagnosis of bipolar disorder and were experiencing an acute bipolar depressive episode, diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders fourth edition (IV) or fourth edition text revision (IV-TR', 'people with bipolar disorder', 'people with bipolar disorder who are experiencing depressive symptoms', 'adults with bipolar depression', 'Ten studies (647 participants', 'Embase and PsycINFO all years to July 2020', 'adults with bipolar disorder']","['ketamine and midazolam', 'glutamate receptor modulators', 'riluzole vs placebo', 'memantine (two), cytidine (one), N-acetylcysteine (three), and riluzole', 'Placebo', 'ketamine', 'ketamine and other glutamate receptor modulators', 'riluzole versus placebo', 'Ketamine', 'saline placebo', 'ketamine, memantine', 'midazolam', 'placebo', 'ketamine versus midazolam, N-acetylcysteine versus placebo', 'riluzole, memantine, cytidine, and N-acetylcysteine']","['response rate and adverse events', 'remission rate, depression severity change scores, suicidality, cognition, quality of life, and dropout rate', 'depression rating scale scores', 'response, remission or depression rating scale scores', 'remission or acceptability', 'dropout rates']","[{'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0061465', 'cui_str': 'Glutamate Receptor'}, {'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0010715', 'cui_str': 'Cytidine'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.654008,"Ketamine seemed to be more effective in reducing depression rating scale scores (MD -11.81, 95% CI -20.01 to -3.61; P = 0.005; participants = 32; studies = 2; I 2  = 0%, very low-certainty evidence).","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Dean', 'Affiliation': 'Oxford, UK.'}, {'ForeName': 'Tahnee', 'Initials': 'T', 'LastName': 'Marquardt', 'Affiliation': 'Oxford, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Hurducas', 'Affiliation': 'Oxford, UK.'}, {'ForeName': 'Styliani', 'Initials': 'S', 'LastName': 'Spyridi', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health Sciences, Cyprus University of Technology, Lemesos, Cyprus.'}, {'ForeName': 'Annabelle', 'Initials': 'A', 'LastName': 'Barnes', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Cowen', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'McShane', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Hawton', 'Affiliation': 'Centre for Suicide Research, University Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Gin S', 'Initials': 'GS', 'LastName': 'Malhi', 'Affiliation': 'Discipline of Psychiatry, Northern Clinical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Geddes', 'Affiliation': 'UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cipriani', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011611.pub3']
1052,34626273,Factors which influence the complications of external ventricular cerebrospinal fluid drainage.,"BACKGROUND


External ventricular drainage (EVD) is one of the most common neurosurgical procedures in emergencies. This study aims to find out which factors influence the occurrence of EVD-related complications in a comparative investigation of metal needles and polyurethane catheters. This is the first clinical study comparing these two systems.
METHODS


Adult patients undergoing pre-coronal EVD placement via freehand burr hole trepanation were included in this prospective study. The exclusion criteria were the open EVD insertion and/or a pre-existing infectious disease of the central nervous system.
RESULTS


Two hundred consecutive patients were enrolled. Of these, 100 patients were treated by using metal EVD (group 1) and 100 patients with polyurethane catheters (group 2). The overall complication rate was 26% (misplacement 13.5%, hemorrhage 12.5%, infection 2.5%, and dislocation 1%) without statistically significant differences between both groups. Generalized brain edema and midline shift had a significant influence on misplacements (generalized brain edema: p = 0.0002, Cramer-V: 0.307, OR = 7.364, 95% CI: 2.691-20.148; all patients: p = 0.001, Cramer-V: 0.48, OR = 43.5, 95% CI: 4.327-437.295; group 1: p = 0.047, Cramer-V: 0.216, OR = 3.75, 95% CI: 1.064-13.221; group 2: midline shift: p = 0.038, Cramer-V: 0.195, OR = 3.626, 95% CI: 1.389-9.464) all patients: p = 0.053, Cramer-V: 0.231, OR = 5.533, 95% CI 1.131-27.081; group 1: p = 0.138, Cramer-V: 0.168, OR = 2.769, 95% CI: 0.813-9.429 group 2. Hemorrhages were associated with the use of oral anticoagulants or antiplatelet therapy (p = 0.002; Cramer-V: 0.220, OR = 3.798, 95% CI: 1.572-9.175) with a statistically similar influence in both groups.
CONCLUSION


Generalized brain edema has a significant influence on misplacements in both groups. Midline shift lost its significance when considering only the patients in group 2. Patients under oral anticoagulation and antiplatelet therapy have increased odds of EVD-associated hemorrhage. Metal needles and polyurethane catheters are equivalent in terms of patient safety when there are no midline shift and generalized brain edema.",2022,"The overall complication rate was 26% (misplacement 13.5%, hemorrhage 12.5%, infection 2.5%, and dislocation 1%) without statistically significant differences between both groups.","['Adult patients undergoing pre-coronal EVD placement via freehand burr hole trepanation', '100 patients were treated by using metal EVD (group 1) and 100 patients with', 'Two hundred consecutive patients were enrolled']","['Metal needles and polyurethane catheters', 'External ventricular drainage (EVD', 'polyurethane catheters', 'metal needles and polyurethane catheters']","['Hemorrhages', 'Generalized brain edema and midline shift', 'overall complication rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0948930', 'cui_str': 'Ventricular drainage'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040836', 'cui_str': 'Trephination of cranium'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0032616', 'cui_str': 'Polyisocyanate'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0948930', 'cui_str': 'Ventricular drainage'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",200.0,0.0753297,"The overall complication rate was 26% (misplacement 13.5%, hemorrhage 12.5%, infection 2.5%, and dislocation 1%) without statistically significant differences between both groups.","[{'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'Kerry', 'Affiliation': 'Department of Neurosurgery, Klinikum Nuremberg, Paracelsus Medical University, Nuremberg, Germany. Ghassan.Kerry@klinikum-nuernberg.de.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Holtmannspoetter', 'Affiliation': 'Department of Neuroradiology, Klinikum Nuremberg, Paracelsus Medical University, Nuremberg, Germany.'}, {'ForeName': 'Jens Christian', 'Initials': 'JC', 'LastName': 'Kubitz', 'Affiliation': 'Department of Anesthesiology, Klinikum Nuremberg, Paracelsus Medical University, Nuremberg, Germany.'}, {'ForeName': 'Hans-Herbert', 'Initials': 'HH', 'LastName': 'Steiner', 'Affiliation': 'Department of Neurosurgery, Klinikum Nuremberg, Paracelsus Medical University, Nuremberg, Germany.'}]",Acta neurochirurgica,['10.1007/s00701-021-05007-7']
1053,34626672,Do Extremely Low Gestational Age Neonates Regulate Iron Absorption via Hepcidin?,"OBJECTIVES


To evaluate whether extremely preterm infants regulate iron status via hepcidin.
STUDY DESIGN


In this retrospective analysis of infants from the Preterm Epo Neuroprotection (PENUT) Trial, urine hepcidin (Uhep) normalized to creatinine (Uhep/UCr) was evaluated among infants randomized to erythropoietin (Epo) or placebo.
RESULTS


The correlation (r) between Uhep/UCr and serum markers of iron status (ferritin and zinc protoporphyrin-to-heme ratio [ZnPP/H]) and iron dose was assessed. A total of 243 urine samples from 76 infants born at 24-27 6/7  weeks gestation were analyzed. The median Uhep/UCr concentration was 0.3, 1.3, 0.4, and 0.1 ng/mg at baseline, 2 weeks, 4 weeks, and 12 weeks, respectively, in placebo-treated infants. The median Uhep/UCr value in Epo-treated infants were not significantly different, with the exception of the value at the 2-week time point (median Uhep/UCr, 0.1 ng/mg; P < .001). A significant association was seen between Uhep/UCr and ferritin at 2 weeks (r = 0.63; P < .001) and at 4 weeks (r = 0.41; P = .01) and between Uhep/UCr and ZnPP/H at 2 weeks (r = -0.49; P = .002).
CONCLUSIONS


Uhep/UCr values correlate with serum iron markers. Uhep/UCr values vary over time and are affected by treatment with Epo, suggesting that extremely preterm neonates can regulate hepcidin and therefore their iron status. Uhep is suppressed in extremely preterm neonates, particularly those treated with Epo.",2022,The correlation (r) between Uhep/UCr and serum markers of iron status (ferritin and zinc protoporphyrin-to-heme ratio (ZnPP/H)) and iron dose was assessed.,"['A total of 243 urine samples from 76 infants born at 24-27 6/7 weeks gestation were analyzed', 'extremely preterm infants regulate iron status via hepcidin', 'infants from the Preterm Epo Neuroprotection (PENUT) Trial']",['erythropoietin (Epo) or placebo'],"['Median Uhep/UCr values', 'serum markers of iron status (ferritin and zinc protoporphyrin-to-heme ratio (ZnPP/H)) and iron dose']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0598958', 'cui_str': 'Neuron Protection'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0078791', 'cui_str': 'Zinc protoporphyrin'}, {'cui': 'C0018966', 'cui_str': 'Heme'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.142669,The correlation (r) between Uhep/UCr and serum markers of iron status (ferritin and zinc protoporphyrin-to-heme ratio (ZnPP/H)) and iron dose was assessed.,"[{'ForeName': 'Kendell R', 'Initials': 'KR', 'LastName': 'German', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, WA. Electronic address: germank@uw.edu.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Comstock', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Parikh', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, Children's Hospital of San Antonio, San Antonio, TX.""}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Whittington', 'Affiliation': 'Department of Medicinal Chemistry, University of Washington, Seattle, WA.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Mayock', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, WA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Bahr', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, WA.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2021.09.059']
1054,34628939,SLEAP SMART (Sleep Apnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke): A Randomized Controlled Trial.,"BACKGROUND AND PURPOSE


Poststroke/transient ischemic attack obstructive sleep apnea (OSA) is prevalent, linked with numerous unfavorable health consequences, but remains underdiagnosed. Reasons include patient inconvenience and costs associated with use of in-laboratory polysomnography (iPSG), the current standard tool. Fortunately, home sleep apnea testing (HSAT) can accurately diagnose OSA and is potentially more convenient and cost-effective compared with iPSG. Our objective was to assess whether screening for OSA in patients with stroke/transient ischemic attack using HSAT, compared with standard of care using iPSG, increased diagnosis and treatment of OSA, improved clinical outcomes and patient experiences with sleep testing, and was a cost-effective approach.
METHODS


We consecutively recruited 250 patients who had sustained a stroke/transient ischemic attack within the past 6 months. Patients were randomized (1:1) to use of (1) HSAT versus (2) iPSG. Patients completed assessments and questionnaires at baseline and 6-month follow-up appointments. Patients diagnosed with OSA were offered continuous positive airway pressure. The primary outcome was compared between study arms via an intention-to-treat analysis.
RESULTS


At 6 months, 94 patients completed HSAT and 71 patients completed iPSG. A significantly greater proportion of patients in the HSAT arm were diagnosed with OSA (48.8% versus 35.2%,  P =0.04) compared with the iPSG arm. Furthermore, patients assigned to HSAT, compared with iPSG, were more likely to be prescribed continuous positive airway pressure (40.0% versus 27.2%), report significantly reduced sleepiness, and a greater ability to perform daily activities. Moreover, a significantly greater proportion of patients reported a positive experience with sleep testing in the HSAT arm compared with the iPSG arm (89.4% versus 31.1%). Finally, a cost-effectiveness analysis revealed that HSAT was economically attractive for the detection of OSA compared with iPSG.
CONCLUSIONS


In patients with stroke/transient ischemic attack, use of HSAT compared with iPSG increases the rate of OSA diagnosis and treatment, reduces daytime sleepiness, improves functional outcomes and experiences with sleep testing, and could be an economically attractive approach. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02454023.",2022,"Finally, a cost-effectiveness analysis revealed that HSAT was economically attractive for the detection of OSA compared with iPSG.
","['patients with stroke/transient ischemic attack', 'Patients diagnosed with OSA', 'After TIA/Stroke', '250 patients who had sustained a stroke/transient ischemic attack within the past 6 months', 'patients with stroke/transient ischemic attack using', 'Poststroke/transient ischemic attack obstructive sleep apnea (OSA']","['iPSG', 'HSAT', 'home sleep apnea testing (HSAT', 'SLEAP SMART', 'HSAT versus (2) iPSG', 'Mobile Ambulatory Recorders']","['Sleep Apnea Screening', 'positive experience with sleep testing', 'intention-to-treat analysis', 'functional outcomes and experiences with sleep testing', 'continuous positive airway pressure', 'greater ability to perform daily activities', 'rate of OSA diagnosis and treatment, reduces daytime sleepiness', 'OSA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0182913', 'cui_str': 'Recorder'}]","[{'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}]",250.0,0.0880588,"Finally, a cost-effectiveness analysis revealed that HSAT was economically attractive for the detection of OSA compared with iPSG.
","[{'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'Boulos', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (M.I.B., M.K., D.R.C., N.K., D.J.G., K.B., A.S., J.J.H., R.H.S., B.J.M.).'}, {'ForeName': 'Maneesha', 'Initials': 'M', 'LastName': 'Kamra', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (M.I.B., M.K., D.R.C., N.K., D.J.G., K.B., A.S., J.J.H., R.H.S., B.J.M.).'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Colelli', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (M.I.B., M.K., D.R.C., N.K., D.J.G., K.B., A.S., J.J.H., R.H.S., B.J.M.).'}, {'ForeName': 'Nardin', 'Initials': 'N', 'LastName': 'Kirolos', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (M.I.B., M.K., D.R.C., N.K., D.J.G., K.B., A.S., J.J.H., R.H.S., B.J.M.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Gladstone', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (M.I.B., M.K., D.R.C., N.K., D.J.G., K.B., A.S., J.J.H., R.H.S., B.J.M.).'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Boyle', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (M.I.B., M.K., D.R.C., N.K., D.J.G., K.B., A.S., J.J.H., R.H.S., B.J.M.).'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sundaram', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (M.I.B., M.K., D.R.C., N.K., D.J.G., K.B., A.S., J.J.H., R.H.S., B.J.M.).'}, {'ForeName': 'Julia J', 'Initials': 'JJ', 'LastName': 'Hopyan', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (M.I.B., M.K., D.R.C., N.K., D.J.G., K.B., A.S., J.J.H., R.H.S., B.J.M.).'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Swartz', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (M.I.B., M.K., D.R.C., N.K., D.J.G., K.B., A.S., J.J.H., R.H.S., B.J.M.).'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Mamdani', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (M.I.B., M.K., D.R.C., N.K., D.J.G., K.B., A.S., J.J.H., R.H.S., B.J.M.).'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Loong', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (M.I.B., M.K., D.R.C., N.K., D.J.G., K.B., A.S., J.J.H., R.H.S., B.J.M.).'}, {'ForeName': 'Wanrudee', 'Initials': 'W', 'LastName': 'Isaranuwatchai', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (M.I.B., M.K., D.R.C., N.K., D.J.G., K.B., A.S., J.J.H., R.H.S., B.J.M.).'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Murray', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (M.I.B., M.K., D.R.C., N.K., D.J.G., K.B., A.S., J.J.H., R.H.S., B.J.M.).'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (M.I.B., M.K., D.R.C., N.K., D.J.G., K.B., A.S., J.J.H., R.H.S., B.J.M.).'}]",Stroke,['10.1161/STROKEAHA.120.033753']
1055,34627809,Three-Year Clinical Trial of Low-Concentration Atropine for Myopia Progression (LAMP) Study: Continued Versus Washout: Phase 3 Report.,"PURPOSE


(1) To compare the efficacy of continued and stopping treatment for 0.05%, 0.025%, and 0.01% atropine during the third year. (2) To evaluate the efficacy of continued treatment over 3 years. (3) To investigate the rebound phenomenon and its determinants after cessation of treatment.
DESIGN


A randomized, double-masked extended trial.
PARTICIPANTS


A total of 350 of 438 children aged 4 to 12 years originally recruited into the Low-Concentration Atropine for Myopia Progression (LAMP) study.
METHODS


At the beginning of the third year, children in each group were randomized at a 1:1 ratio to continued treatment and washout subgroups. Cycloplegic spherical equivalent (SE) refraction and axial length (AL) were measured at 4-month intervals.
MAIN OUTCOME MEASURES


Changes in SE and AL between groups.
RESULTS


A total of 326 children completed 3 years of follow-up. During the third year, SE progression and AL elongation were faster in the washout subgroups than in the continued treatment groups across all concentrations: -0.68 ± 0.49 diopters (D) versus -0.28 ± 0.42 D (P < 0.001) and 0.33 ± 0.17 mm versus 0.17 ± 0.14 mm (P < 0.001) for the 0.05%; -0.57 ± 0.38 D versus -0.35 ± 0.37 D (P = 0.004) and 0.29 ± 0.14 mm versus 0.20 ± 0.15 mm (P = 0.001) for the 0.025%; -0.56 ± 0.40 D versus -0.38 ± 0.49 D (P = 0.04) and 0.29 ± 0.15 mm versus 0.24 ± 0.18 mm (P = 0.13) for the 0.01%. Over the 3-year period, SE progressions were -0.73 ± 1.04 D, -1.31 ± 0.92 D, and -1.60 ± 1.32 D (P = 0.001) for the 0.05%, 0.025%, and 0.01% groups in the continued treatment subgroups, respectively, and -1.15 ± 1.13 D, -1.47 ± 0.77 D, and -1.81 ± 1.10 D (P = 0.03), respectively, in the washout subgroup. The respective AL elongations were 0.50 ± 0.40 mm, 0.74 ± 0.41 mm, and 0.89 ± 0.53 mm (P < 0.001) for the continued treatment subgroups and 0.70 ± 0.47 mm, 0.82 ± 0.37 mm, and 0.98 ± 0.48 mm (P = 0.04) for the washout subgroup. The rebound SE progressions during washout were concentration dependent, but their differences were clinically small (P = 0.15). Older age and lower concentration were associated with smaller rebound effects in both SE progression (P < 0.001) and AL elongation (P < 0.001).
CONCLUSIONS


During the third year, continued atropine treatment achieved a better effect across all concentrations compared with the washout regimen. 0.05% atropine remained the optimal concentration over 3 years in Chinese children. The differences in rebound effects were clinically small across all 3 studied atropine concentrations. Stopping treatment at an older age and lower concentration are associated with a smaller rebound.",2022,"During the third year, SE progression and AL elongation were faster in the washout subgroups than in the continued treatment groups across all concentrations (-0.68±0.49D vs.-0.28±0.42D (P<0.001) and 0.33±0.17mm vs. 0.17±0.14mm (P<0.001) for the 0.05%; -0.57±0.38D vs. -0.35±0.37D (P=0.004) and 0.29±0.14mm vs. 0.20±0.15mm (P=0.04) for the 0.025%; -0.56±0.40D vs.-0.38±0.49D (P=0.04) and 0.29±0.15mm vs 0.24±0.18mm (P=0.13) for the 0.01%).","['Myopia Progression (LAMP', ' 350 of 438 children aged 4-12 years originally recruited into the', '326 children completed 3 years of follow-up', 'for Myopia Progression (LAMP) study METHODS']","['atropine', 'Low-concentration Atropine', 'Low-Concentration Atropine']","['rebound SE progressions', 'SE progression and AL elongation', 'Cycloplegic spherical equivalent (SE) refraction and axial length (AL', 'rebound effects']","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0010586', 'cui_str': 'Cycloplegic preparation'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0549262', 'cui_str': 'Rebound effect'}]",438.0,0.142905,"During the third year, SE progression and AL elongation were faster in the washout subgroups than in the continued treatment groups across all concentrations (-0.68±0.49D vs.-0.28±0.42D (P<0.001) and 0.33±0.17mm vs. 0.17±0.14mm (P<0.001) for the 0.05%; -0.57±0.38D vs. -0.35±0.37D (P=0.004) and 0.29±0.14mm vs. 0.20±0.15mm (P=0.04) for the 0.025%; -0.56±0.40D vs.-0.38±0.49D (P=0.04) and 0.29±0.15mm vs 0.24±0.18mm (P=0.13) for the 0.01%).","[{'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Yam', 'Affiliation': ""Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; Hong Kong Eye Hospital, Hong Kong; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong; Department of Ophthalmology, Hong Kong Children's Hospital, Hong Kong. Electronic address: yamcheuksing@cuhk.edu.hk.""}, {'ForeName': 'Xiu Juan', 'Initials': 'XJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Yuzhou', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Yu Meng', 'Initials': 'YM', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Shu Min', 'Initials': 'SM', 'LastName': 'Tang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; Department of Ophthalmology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Fen Fen', 'Initials': 'FF', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; The Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Ka Wai', 'Initials': 'KW', 'LastName': 'Kam', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong.'}, {'ForeName': 'Simon T', 'Initials': 'ST', 'LastName': 'Ko', 'Affiliation': ""Department of Ophthalmology, Hong Kong Children's Hospital, Hong Kong; Department of Ophthalmology, Tung Wah Eastern Hospital, Hong Kong.""}, {'ForeName': 'Benjamin H K', 'Initials': 'BHK', 'LastName': 'Yip', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Alvin L', 'Initials': 'AL', 'LastName': 'Young', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong.'}, {'ForeName': 'Clement C', 'Initials': 'CC', 'LastName': 'Tham', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; Hong Kong Eye Hospital, Hong Kong; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Li Jia', 'Initials': 'LJ', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Chi Pui', 'Initials': 'CP', 'LastName': 'Pang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong.'}]",Ophthalmology,['10.1016/j.ophtha.2021.10.002']
1056,34632493,Assessing Phlebotomy Device Preference and Specimen Quality in an Oncology Outpatient Clinic.,"BACKGROUND


Oncology patients have frequent venipunctures, which causes scarring, making subsequent draws difficult and painful. Novel blood collection systems may decrease discomfort in patients experiencing repeat blood draws.
METHODS


Oncology outpatients (n = 101; criteria excluded 12) were recruited to determine their preference for either of two blood collection systems, the 23-gauge standard BD Vacutainer Push Button Blood Collection Set (Standard Push Button system) or the 25-gauge BD Vacutainer UltraTouch Push Button Blood Collection Set (UltraTouch Push Button system). Subjects received two blinded, randomized blood draws, one with each device and just one device for each arm. Subjects subsequently rated their blinded preference for blood collection system. Specimen quality was assessed for each device with measurements for plasma hemoglobin (Shimadzu UV-1800 spectrophotometer, Shimadzu), lactate dehydrogenase, and potassium (Vitros 4600/5600 analyzer, Ortho Diagnostics).
RESULTS


Preference for the 25-gauge UltraTouch Push Button system over the 23-gauge Standard Push Button system was significant (UltraTouch, n = 51; Standard n = 30; no preference, n = 8; P = 0.0196). Regarding sample quality, the 25-gauge UltraTouch Push Button system had significantly lower plasma hemoglobin (average 5.34 mg/dL) vs the 23-gauge Standard Push Button system (9.37 mg/dL; P < 0.0001); serum lactate dehydrogenase and potassium differences were not statistically significant.
CONCLUSION


Subjects in an oncology clinic preferred phlebotomy with the 25-gauge UltraTouch Push Button system, and samples using this device had less hemolysis as assessed by plasma hemoglobin.",2022,"RESULTS


Preference for the 25-gauge UltraTouch Push Button system over the 23-gauge Standard Push Button system was significant (UltraTouch, n = 51; Standard n = 30; no preference, n = 8; P = 0.0196).","['Oncology outpatients (n\u2005=\u2005101; criteria excluded 12', 'patients experiencing repeat blood draws', 'Oncology Outpatient Clinic']",['23-gauge standard BD Vacutainer Push Button Blood Collection Set (Standard Push Button system) or the 25-gauge BD Vacutainer UltraTouch Push Button Blood Collection Set (UltraTouch Push Button system'],"['Specimen quality', 'serum lactate dehydrogenase and potassium differences', 'plasma hemoglobin (Shimadzu UV-1800 spectrophotometer, Shimadzu), lactate dehydrogenase, and potassium (Vitros 4600/5600 analyzer, Ortho Diagnostics', 'plasma hemoglobin']","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0456564', 'cui_str': 'Gauges'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0453985', 'cui_str': 'Button'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0456638', 'cui_str': '25G'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0474563', 'cui_str': 'Measurement of total hemoglobin concentration in plasma specimen'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",101.0,0.0388649,"RESULTS


Preference for the 25-gauge UltraTouch Push Button system over the 23-gauge Standard Push Button system was significant (UltraTouch, n = 51; Standard n = 30; no preference, n = 8; P = 0.0196).","[{'ForeName': 'VeRonika D', 'Initials': 'VD', 'LastName': 'Merrill', 'Affiliation': 'Department of Pathology, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Ward', 'Affiliation': 'Department of Pathology, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jovita', 'Initials': 'J', 'LastName': 'Diaz-McNair', 'Affiliation': 'Department of Pathology, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Pickett', 'Affiliation': 'Department of Pathology, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Show-Hong', 'Initials': 'SH', 'LastName': 'Duh', 'Affiliation': 'Department of Pathology, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Christenson', 'Affiliation': 'Department of Pathology, University of Maryland School of Medicine, Baltimore, MD, USA.'}]",The journal of applied laboratory medicine,['10.1093/jalm/jfab109']
1057,34980020,PIONEER-Panc: a platform trial for phase II randomized investigations of new and emerging therapies for localized pancreatic cancer.,"BACKGROUND


Personalized and effective treatments for pancreatic ductal adenocarcinoma (PDAC) continue to remain elusive. Novel clinical trial designs that enable continual and rapid evaluation of novel therapeutics are needed. Here, we describe a platform clinical trial to address this unmet need.
METHODS


This is a phase II study using a Bayesian platform design to evaluate multiple experimental arms against a control arm in patients with PDAC. We first separate patients into three clinical stage groups of localized PDAC (resectable, borderline resectable, and locally advanced disease), and further divide each stage group based on treatment history (treatment naïve or previously treated). The clinical stage and treatment history therefore define 6 different cohorts, and each cohort has one control arm but may have one or more experimental arms running simultaneously. Within each cohort, adaptive randomization rules are applied and patients will be randomized to either an experimental arm or the control arm accordingly. The experimental arm(s) of each cohort are only compared to the applicable cohort specific control arm. Experimental arms may be added independently to one or more cohorts during the study. Multiple correlative studies for tissue, blood, and imaging are also incorporated.
DISCUSSION


To date, PDAC has been treated as a single disease, despite knowledge that there is substantial heterogeneity in disease presentation and biology. It is recognized that the current approach of single arm phase II trials and traditional phase III randomized studies are not well-suited for more personalized treatment strategies in PDAC. The PIONEER Panc platform clinical trial is designed to overcome these challenges and help advance our treatment strategies for this deadly disease.
TRIAL REGISTRATION


This study is approved by the Institutional Review Board (IRB) of MD Anderson Cancer Center, IRB-approved protocol 2020-0075. The PIONEER trial is registered at the US National Institutes of Health (ClinicalTrials.gov) NCT04481204 .",2022,"Within each cohort, adaptive randomization rules are applied and patients will be randomized to either an experimental arm or the control arm accordingly.","['patients with PDAC', 'localized pancreatic cancer', 'separate patients into three clinical stage groups of localized PDAC (resectable, borderline resectable, and locally advanced disease), and further divide each stage group based on treatment history (treatment naïve or previously treated', 'pancreatic ductal adenocarcinoma (PDAC']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",[],[],,0.0742998,"Within each cohort, adaptive randomization rules are applied and patients will be randomized to either an experimental arm or the control arm accordingly.","[{'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Douglas', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1220 Holcombe Boulevard, MS97, Houston, TX, 77030, USA.'}, {'ForeName': 'Suyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wolff', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Shubham', 'Initials': 'S', 'LastName': 'Pant', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Anirban', 'Initials': 'A', 'LastName': 'Maitra', 'Affiliation': 'Sheikh Ahmed Center for Pancreatic Cancer Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Tamm', 'Affiliation': 'Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Bhosale', 'Affiliation': 'Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Matthew H G', 'Initials': 'MHG', 'LastName': 'Katz', 'Affiliation': 'Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Gauri R', 'Initials': 'GR', 'LastName': 'Varadhachary', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Eugene J', 'Initials': 'EJ', 'LastName': 'Koay', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1220 Holcombe Boulevard, MS97, Houston, TX, 77030, USA. EKoay@mdanderson.org.'}]",BMC cancer,['10.1186/s12885-021-09095-7']
1058,34615617,Morbidity and mortality in elderly patients with heart failure managed with a comprehensive care model vs. usual care: The UMIPIC program.,"BACKGROUND


Elderly patients with heart failure (HF) have a high degree of comorbidity which leads to fragmented care, with frequent hospitalizations and high mortality. This study evaluated the benefit of a comprehensive continuous care model (UMIPIC program) in elderly HF patients.
METHODS AND RESULTS


We prospectively analyzed data from the RICA registry on 2862 patients with HF treated in internal medicine departments. They were divided into two groups: one monitored in the UMIPIC program (UMIPIC group, n: 809) and another which received conventional care (RICA group, n: 2.053). We evaluated HF readmissions during 12 months of follow-up and total mortality after episodes of HF hospitalization. UMIPIC patients were older with higher rates of comorbidity and preserved ejection fraction than the RICA group. However, the UMIPIC group had a lower rate of HF readmissions (17% vs. 26%, p < .001) and mortality (16% vs. 27%, respectively; p < .001). In addition, we selected 370 propensity score-matched patients from each group and the differences in HF readmissions (15% UMIPIC vs. 30% RICA; hazard ratio [HR] = 0.44; 95% confidence interval [CI] 0.32-0.60; p < .001) and mortality (17% UMIPIC vs. 28% RICA; hazard ratio = 0.58; 95% CI 0.42-0.79; p = .001) were maintained.
CONCLUSIONS


The implementation of the UMIPIC program, based on comprehensive continuous care of elderly patients with HF and high comorbidity, markedly reduce HF readmissions and total mortality.",2022,"However, the UMIPIC group had a lower rate of HF readmissions (17% vs. 26%, p < .001) and mortality (16% vs. 27%, respectively; p < .001).","['elderly patients with heart failure managed with a comprehensive care model vs. usual care', 'elderly patients with HF and high comorbidity', '2862 patients with HF treated in internal medicine departments', 'elderly HF patients', 'Elderly patients with heart failure (HF']","['comprehensive continuous care model (UMIPIC program', 'UMIPIC program (UMIPIC group, n: 809) and another which received conventional care (RICA']","['HF readmissions and total mortality', 'mortality', 'HF readmissions', 'rate of HF readmissions', 'Morbidity and mortality']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",2862.0,0.067955,"However, the UMIPIC group had a lower rate of HF readmissions (17% vs. 26%, p < .001) and mortality (16% vs. 27%, respectively; p < .001).","[{'ForeName': 'Á', 'Initials': 'Á', 'LastName': 'González-Franco', 'Affiliation': 'Servicio de Medicina Interna, Hospital Universitario Central de Asturias, Oviedo, Spain. Electronic address: alvarogfranco@yahoo.com.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Cerqueiro González', 'Affiliation': 'Servicio de Medicina Interna, Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Arévalo-Lorido', 'Affiliation': 'Servicio de Medicina Interna, Hospital Comarcal de Zafra, Zafra, Badajoz, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Álvarez-Rocha', 'Affiliation': 'Servicio de Medicina Interna y Cardiología, Hospital de Clínicas Dr. Manuel Quintela, Montevideo, Uruguay.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Carrascosa-García', 'Affiliation': 'Servicio de Medicina Interna, Consorcio Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Armengou', 'Affiliation': 'Servicio de Medicina Interna, Hospital Universitari de Girona Dr. Josep Trueta, Girona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Guzmán-García', 'Affiliation': 'Servicio de Medicina Interna, Hospital San Juan de la Cruz, Jaén, Spain.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Trullàs', 'Affiliation': ""Servicio de Medicina Interna, Hospital d'Olot i comarcal de la Garrotxa, Girona, Spain; Laboratori de Reparació i Regeneració Tissular (TR2Lab), Facultat de Medicina, Universitat de Vic - Universitat Central de Catalunya, Vic, Barcelona, Spain.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Montero-Pérez-Barquero', 'Affiliation': 'Servicio de Medicina Interna, IMIBIC/Hospital Universitario Reina Sofía, Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Manzano', 'Affiliation': 'Servicio de Medicina Interna, Hospital Universitario Ramón y Cajal, Universidad de Alcalá (IRYCIS), Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Revista clinica espanola,['10.1016/j.rceng.2021.05.007']
1059,34618513,Therapist-level moderation of within- and between-therapist process-outcome associations.,"OBJECTIVE


Although higher quality patient-therapist alliance and more positive patient outcome expectation (OE) consistently predict symptomatic/functional improvement in psychotherapy, most research has failed to capture the nuance in these process-outcome relations by parsing them into  within-therapist  (i.e., differences between patients treated by the same therapist) and  between-therapist  (i.e., differences between therapists' average process/outcome ratings across all patients in their caseloads) components. Moreover, the few studies that have done so have produced mixed results, suggesting the possibility of systematic variability in these associations (i.e., moderators). One potential source of such variability could be providers themselves; that is, different therapists could use these processes to differing therapeutic benefit. This study tested the alliance- and OE-outcome associations at both the within- and between-therapist levels and explored therapist-level moderators of them.
METHOD


Data derived from 212 adult outpatients treated naturalistically by 42 psychotherapists as part of a randomized trial that compared different case-assignment methods. Patients completed measures of alliance, OE, and outcome repeatedly throughout treatment. Therapist characteristics were assessed at baseline.
RESULTS


Multilevel structural equation models revealed that, at the between-therapist level, only higher alliance quality, but not more optimistic OE, was associated with greater caseload-level improvement. At the within-therapist level, only more optimistic OE, but not higher alliance quality, was associated with patient improvement. Finally, therapists' self-perceived alliance-fostering effectiveness and cognitive-behavioral orientation moderated the within- and between-therapist alliance-outcome associations, respectively.
CONCLUSION


Results indicate that different therapists use common treatment processes to differing therapeutic benefit, which can inform more personalized clinical practices and trainings. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,"At the within-therapist level, only more optimistic OE, but not higher alliance quality, was associated with patient improvement.",['212 adult outpatients treated naturalistically by 42 psychotherapists as part of a randomized trial that compared different case-assignment methods'],[],"['optimistic OE', 'alliance quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0557555', 'cui_str': 'Psychotherapist'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],"[{'cui': 'C0564470', 'cui_str': 'Optimistic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",212.0,0.0911043,"At the within-therapist level, only more optimistic OE, but not higher alliance quality, was associated with patient improvement.","[{'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Coyne', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Constantino', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Boswell', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Kraus', 'Affiliation': 'Outcome Referrals, Inc.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000676']
1060,34628506,Designing More Effective Cigar Warnings: An Experiment Among Adult Cigar Smokers.,"INTRODUCTION


Little systematic evidence exists about the effectiveness of cigar warnings. This study examined the perceived message effectiveness (PME) of warning statements about different health consequences caused by cigars. PME is a validated self-report scale of how effectively a health message discourages smoking.
AIMS AND METHODS


We conducted an online study from April to May 2020 with adults in the United States who used cigars in the past 30 days (n = 777). Participants were randomly assigned to view and rate PME (three items, range 1-5) for seven out of 37 text warning statements about different health consequences from cigar use. Linear mixed effects models evaluated the most effective warning characteristics (eg, type of health consequence), controlling for repeated measures and participant demographics.
RESULTS


Analyses showed that health consequences about the cardiovascular system (B = 0.38), mouth (B = 0.40), other digestive (B = 0.45), respiratory system (B = 0.36), and early death (B = 0.36) were associated with higher PME scores than reproductive health consequences (all p values <.001). Similar results were found for these health consequences compared with addiction (all p values p < .001). We also observed that awareness of the health consequence was associated with higher PME scores (B = 0.19, p < .001) and length of the warning message (number of characters) was associated with lower PME scores (B = -0.007, p = .03). No differences were observed between cancer and noncancer health consequences (p = .27) or health consequences that used plain language versus medical jargon (p = .94).
CONCLUSIONS


Our study provides new evidence about the perceived effectiveness of different cigar health warning statements and identifies features that may strengthen statements.
IMPLICATIONS


Our study with cigar smokers from across the United States provides much-needed evidence concerning the perceived effectiveness of different cigar health warning statements and features that may strengthen such statements. Mandated cigar warnings in the United States could be strengthened by including health consequences that were perceived as more effective in our study (eg, early death), using health consequences that participants were aware of, and using short warning statements.",2022,Similar results were found for these health consequences compared to addiction (all p-values p<0.001).,"['adult cigar smokers', '2020 with adults in the United States who used cigars in the past 30 days (n=777', 'cigar smokers']",['PME'],"['early death', 'PME scores', 'cancer and non-cancer health consequences', 'health consequences about the cardiovascular system', 'respiratory system']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337666', 'cui_str': 'Cigar smoker'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0678446', 'cui_str': 'Cigar'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}]",,0.0411778,Similar results were found for these health consequences compared to addiction (all p-values p<0.001).,"[{'ForeName': 'Sarah D', 'Initials': 'SD', 'LastName': 'Kowitt', 'Affiliation': 'Department of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Jarman', 'Affiliation': 'Department of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cornacchione Ross', 'Affiliation': 'Department of Social Sciences and Health Policy, Division of Public Health Sciences, Wake Forest School of Medicine, Winston Salem, NC, USA.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Ranney', 'Affiliation': 'Department of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Caleb A', 'Initials': 'CA', 'LastName': 'Smith', 'Affiliation': 'School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Kistler', 'Affiliation': 'Department of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Paschal', 'Initials': 'P', 'LastName': 'Sheeran', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Thrasher', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Adam O', 'Initials': 'AO', 'LastName': 'Goldstein', 'Affiliation': 'Department of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab207']
1061,34628482,Effects of the selective orexin-2 receptor antagonist JNJ-48816274 on sleep initiated in the circadian wake maintenance zone: a randomised trial.,"The effects of orexinergic peptides are diverse and are mediated by orexin-1 and orexin-2 receptors. Antagonists that target both receptors have been shown to promote sleep initiation and maintenance. Here, we investigated the role of the orexin-2 receptor in sleep regulation in a randomised, double-blind, placebo-controlled, three-period crossover clinical trial using two doses (20 and 50 mg) of a highly selective orexin-2 receptor antagonist (2-SORA) (JNJ-48816274). We used a phase advance model of sleep disruption where sleep initiation is scheduled in the circadian wake maintenance zone. We assessed objective and subjective sleep parameters, pharmacokinetic profiles and residual effects on cognitive performance in 18 healthy male participants without sleep disorders. The phase advance model alone (placebo condition) resulted in disruption of sleep at the beginning of the sleep period compared to baseline sleep (scheduled at habitual time). Compared to placebo, both doses of JNJ-48816274 significantly increased total sleep time, REM sleep duration and sleep efficiency, and reduced latency to persistent sleep, sleep onset latency, and REM latency. All night EEG spectral power density for both NREM and REM sleep were unaffected by either dose. Participants reported significantly better quality of sleep and feeling more refreshed upon awakening following JNJ-48816274 compared to placebo. No significant residual effects on objective performance measures were observed and the compound was well tolerated. In conclusion, the selective orexin-2 receptor antagonist JNJ-48816274 rapidly induced sleep when sleep was scheduled earlier in the circadian cycle and improved self-reported sleep quality without impact on waking performance.",2022,"Compared to placebo, both doses of JNJ-48816274 significantly increased total sleep time, REM sleep duration and sleep efficiency, and reduced latency to persistent sleep, sleep onset latency, and REM latency.",['18 healthy male participants without sleep disorders'],"['highly selective orexin-2 receptor antagonist (2-SORA) (JNJ-48816274', 'selective orexin-2 receptor antagonist JNJ-48816274', 'placebo']","['disruption of sleep', 'total sleep time, REM sleep duration and sleep efficiency, and reduced latency to persistent sleep, sleep onset latency, and REM latency', 'objective performance measures', 'tolerated', 'All night EEG spectral power density for both NREM and REM sleep', 'quality of sleep and feeling more refreshed upon awakening']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1113688', 'cui_str': 'Orexin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C1275624', 'cui_str': 'Porzana carolina'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}]",18.0,0.0741756,"Compared to placebo, both doses of JNJ-48816274 significantly increased total sleep time, REM sleep duration and sleep efficiency, and reduced latency to persistent sleep, sleep onset latency, and REM latency.","[{'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Revell', 'Affiliation': 'Surrey Sleep Research Centre, University of Surrey, Guildford, Surrey, GU2 7XP, UK.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Della Monica', 'Affiliation': 'Surrey Sleep Research Centre, University of Surrey, Guildford, Surrey, GU2 7XP, UK.'}, {'ForeName': 'Jeewaka', 'Initials': 'J', 'LastName': 'Mendis', 'Affiliation': 'Surrey Clinical Trials Unit, University of Surrey, Guildford, Surrey, GU2 7XP, UK.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Hassanin', 'Affiliation': 'Surrey Clinical Research Facility, University of Surrey, Guildford, Surrey, GU2 7XP, UK.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'Halter', 'Affiliation': 'Janssen Research & Development, LLC, San Diego, CA, USA.'}, {'ForeName': 'Sandra R', 'Initials': 'SR', 'LastName': 'Chaplan', 'Affiliation': 'Janssen Research & Development, LLC, San Diego, CA, USA.'}, {'ForeName': 'Derk-Jan', 'Initials': 'DJ', 'LastName': 'Dijk', 'Affiliation': 'Surrey Sleep Research Centre, University of Surrey, Guildford, Surrey, GU2 7XP, UK. d.j.dijk@surrey.ac.uk.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-01175-3']
1062,34636474,Safety and efficacy of the transoral approach for cheek volumization with hyaluronic acid: A pilot study.,"BACKGROUND


With aging, there is a decrease in the volume of facial fat compartments, which can be restored using injectable biodegradable fillers.
AIMS


The objective of this study was to assess the efficacy and safety of an ultrasound-guided transoral injection versus the traditional percutaneous approach for cheek volumization with hyaluronic acid.
PATIENTS/METHODS


This is a pilot, single-center, comparative, prospective study conducted in Spain in which the hemifaces were randomized to receive an injection with each technique, and the duration of follow-up was 1 year. Results were assessed using the GAIS and the procedure satisfaction survey. The degree of pain experienced was evaluated using a VAS for pain.
RESULTS


This study included 20 women with a mean age of 45.3 years (SD 5.1, range of 38-53). No significant differences were observed in esthetic improvement scores or in the satisfaction surveys. There were significant differences in the transoral approach assessment at V3 (p = 0.0362) and in both procedures at V6 (p = 0.0026) between patients and evaluators. Of all patients, 55% (n = 11/20) reported less pain with the transoral approach, and 15% (n = 3/20) did not perceive pain with any techniques. No side effects different than those expected were observed, and they all resolved without the need for treatment.
CONCLUSION


The transoral approach for cheek volumization with hyaluronic acid was shown as a safe, effective technique that provides more comfort and minor sensation of pain than the traditional percutaneous approach but with equivalent esthetic outcomes.",2022,There were significant differences in the transoral approach assessment at V3 (p = 0.0362) and in both procedures at V6 (p = 0.0026) between patients and evaluators.,"['20 women with a mean age of 45.3\xa0years (SD 5.1, range of 38-53']","['hyaluronic acid', 'ultrasound-guided transoral injection', 'transoral approach']","['pain', 'Safety and efficacy', 'esthetic improvement scores', 'degree of pain', 'efficacy and safety']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",20.0,0.0141417,There were significant differences in the transoral approach assessment at V3 (p = 0.0362) and in both procedures at V6 (p = 0.0026) between patients and evaluators.,"[{'ForeName': 'Jesús Luis', 'Initials': 'JL', 'LastName': 'Oliva Hernández', 'Affiliation': 'Clínica Luis Oliva, Tenerife, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'García Monforte', 'Affiliation': 'Clínica Renacimiento, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Tejero García', 'Affiliation': 'Clínica Mediestetic, Toledo, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Hernández Ponce', 'Affiliation': 'Hospital Universitario Nuestra Señora de la Candelaria, Tenerife, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Naranjo García', 'Affiliation': 'Clínca Elite Laser, Madrid, Spain.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14523']
1063,34620759,"Growth of Very Low Birth Weight Infants Who Received a Liquid Human Milk Fortifier: A Randomized, Controlled Multicenter Trial.","OBJECTIVES


To evaluate growth (weight, length, head circumference, and knee-heel length [KHL]) in very low birth weight (VLBW) infants (500-1500 g) who received human milk with a liquid fortifier (LHMF) with high protein and fatty acid content versus a traditional powder fortifier (PHMF) for 45 days or until discharge.
METHODS


This was a multicenter, randomized, controlled trial. An intention-to-treat analysis was performed to determine adverse events and withdrawal causes. We also performed an efficacy analysis involving the infants who completed at least 2 weeks of study.
RESULTS


Of the 158 infants enrolled in the study, 146 completed at least 2 weeks, and 125 completed the entire study. The biodemographic characteristics were similar between groups, with no differences in increments of weight (22.9 vs 22.7 g kg-1 day-1), length (1.03 vs 1.09 cm/week), head circumference (0.91 vs 0.90 cm/week), or KHL (3.6 vs 3.3 mm/week). The KHL increment was greater in infants weighing >1 kg receiving LHMF (3.7 vs 3.2 mm/week, P = 0.027). Although there were no significant differences in serious adverse events, the incidence difference of the composite outcome death/necrotizing enterocolitis between groups warrants attention (1.3% with LHMF and 8.1% with PHMF).
CONCLUSION


There were no differences in the overall growth between VLBW infants receiving either fortifier.",2022,"Although there were no significant differences in serious adverse events, the incidence difference of the composite outcome death/necrotizing enterocolitis between groups warrants attention (1.3% with LHMF and 8.1% with PHMF).
","['infants who completed at least 2\u200aweeks of study', 'very low birth weight (VLBW) infants (500-1,500\u200ag) who received', 'Very Low Birth Weight Infants', '158 infants enrolled in the study, 146 completed at least 2\u200aweeks, and 125 completed the entire study']","['human milk with a liquid fortifier (LHMF) with high protein and fatty acid content versus a traditional powder fortifier (PHMF', 'Liquid Human Milk Fortifier']","['weight', 'biodemographic characteristics', 'KHL increment', 'composite outcome death/necrotizing enterocolitis', 'overall growth', 'serious adverse events', 'growth (weight, length, head circumference, and knee-heel length [KHL', 'head circumference']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439751', 'cui_str': 'Entire'}]","[{'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C3853188', 'cui_str': 'Human milk fortifier'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}]",158.0,0.195168,"Although there were no significant differences in serious adverse events, the incidence difference of the composite outcome death/necrotizing enterocolitis between groups warrants attention (1.3% with LHMF and 8.1% with PHMF).
","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Masoli', 'Affiliation': 'Department of Neonatology, School of Medicine, Pontificia Universidad Católica de Chile.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Mena', 'Affiliation': 'Hospital Dr. Sótero del Río, Department of Neonatology, School of Medicine, Pontificia Universidad Católica de Chile.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Dominguez', 'Affiliation': 'Department of Public Health, School of Medicine, Pontificia Universidad Católica de Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Ramolfo', 'Affiliation': 'Division of Neonatology, Hospital Gustavo Fricke, Viña del Mar, Chile.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Vernal', 'Affiliation': 'Division of Neonatology, Hospital San José, Universidad de Chile.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Pantoja', 'Affiliation': 'Division of Neonatology, Hospital San Borja- Arriarán, Universidad de Chile.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Esparza', 'Affiliation': 'Division of Neonatology, Hospital Guillermo Grant Benavente, Concepción, Chile.'}, {'ForeName': 'Maria Eugenia', 'Initials': 'ME', 'LastName': 'Hübner', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Clínica Alemana/ Faculty of Medicine, Clínica Alemana- Universidad del Desarrollo, Chile.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ríos', 'Affiliation': 'Division of Neonatology, Clínica Dávila, Chile.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Faunes', 'Affiliation': 'School of Nursing, Pontificia Universidad Católica de Chile.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Uauy', 'Affiliation': 'Department of Neonatology, School of Medicine, Pontificia Universidad Católica de Chile.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Tapia', 'Affiliation': 'Department of Neonatology, School of Medicine, Pontificia Universidad Católica de Chile.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000003321']
1064,34624497,"International Tailored Chemotherapy Adjuvant (ITACA) trial, a phase III multicenter randomized trial comparing adjuvant pharmacogenomic-driven chemotherapy versus standard adjuvant chemotherapy in completely resected stage II-IIIA non-small-cell lung cancer.","BACKGROUND


Several strategies have been investigated to improve the 4% survival advantage of adjuvant chemotherapy in early-stage non-small-cell lung cancer (NSCLC). In this investigator-initiated study we aimed to evaluate the predictive utility of the messenger RNA (mRNA) expression levels of excision repair cross complementation group 1 (ERCC1) and thymidylate synthase (TS) as assessed in resected tumor.
PATIENTS AND METHODS


Seven hundred and seventy-three completely resected stage II-III NSCLC patients were enrolled and randomly assigned in each of the four genomic subgroups to investigator's choice of platinum-based chemotherapy (C, n = 389) or tailored chemotherapy (T, n = 384). All anticancer drugs were administered according to standard doses and schedules. Stratification factors included stage and smoking status. The primary endpoint of the study was overall survival (OS).
RESULTS


Six hundred and ninety patients were included in the primary analysis. At a median follow-up of 45.9 months, 85 (24.6%) and 70 (20.3%) patients died in arms C and T, respectively. Five-year survival for patients in arms C and T was of 65.4% (95% CI (confidence interval): 58.5% to 71.4%) and 72.9% (95% CI: 66.5% to 78.3%), respectively. The estimated hazard ratio (HR) was 0.77 (95% CI: 0.56-1.06, P value: 0.109) for arm T versus arm C. HR for recurrence-free survival was 0.89 (95% CI: 0.69-1.14, P value: 0.341) for arm T versus arm C. Grade 3-5 toxicities were more frequently reported in arm C than in arm T.
CONCLUSION


In completely resected stage II-III NSCLC tailoring adjuvant chemotherapy conferred a non-statistically significant trend for OS favoring the T arm. In terms of safety, the T arm was associated with better efficacy/toxicity ratio related to the different therapeutic choices in the experimental arm.",2022,"5-year survival for patients in arms C and T was of 65.4% (95%CI: 58.5-71.4%) and 72.9% (95%CI: 66.5-78.3%), respectively.","['early-stage non-small cell lung cancer (NSCLC', 'Six hundred and ninety patients were included in the primary analysis', 'Seven hundred seventy-three completely resected stage II-III', 'NSCLC patients']","['platinum-based chemotherapy (C, n=389) or tailored chemotherapy', 'NSCLC tailoring adjuvant chemotherapy', 'Adjuvant Pharmacogenomic-Driven Chemotherapy versus Standard Adjuvant Chemotherapy', 'adjuvant chemotherapy']","['efficacy/toxicity ratio', 'recurrence-free survival', '5-year survival', 'estimated hazard ratio (HR', 'overall survival (OS']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1138555', 'cui_str': 'Pharmacogenomic specialist'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",690.0,0.464268,"5-year survival for patients in arms C and T was of 65.4% (95%CI: 58.5-71.4%) and 72.9% (95%CI: 66.5-78.3%), respectively.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'Department of Oncology at San Luigi Hospital, University of Torino, Orbassano (Torino), Italy. Electronic address: silvia.novello@unito.it.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Oncology Department at Instituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Grohe', 'Affiliation': 'Department of Respiratory Diseases, Evangelische Lungenklinik Berlin, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kurz', 'Affiliation': 'Evangelische Lungenklinik Berlin, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Serke', 'Affiliation': 'Thorax Center Clinic for Haematology, Oncology, Pulmonology and Palliative Medicine, Evangelisches Krankenhaus Hamm, Hamm, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wehler', 'Affiliation': 'Thorax Center Clinic for Haematology, Oncology, Pulmonology and Palliative Medicine, Evangelisches Krankenhaus Hamm, Hamm, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'Department of Pneumology, Maria Hilf Hospital, Moenchengladbach, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ladage', 'Affiliation': 'Department of Pneumology, Maria Hilf Hospital, Moenchengladbach, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Geissler', 'Affiliation': 'Esslingen Cancer Center Department of Oncology, Gastroenterology and Infectious Diseases Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Colantonio', 'Affiliation': 'Division of Oncology, Azienda Ospedaliera Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cauchi', 'Affiliation': 'Division of Oncology, Azienda Ospedaliera Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stoelben', 'Affiliation': 'Lung Clinic, Cologne-Merheim Hospital, Cologne, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ceribelli', 'Affiliation': 'Division of Clinical Oncology A, Istituto Nazionale Regina Elena per lo Studio e la Cura dei Tumori, Rome, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kropf-Sanchen', 'Affiliation': 'Department of Pulmonology, Internal Medicine II, University of Ulm, Ulm, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Valmadre', 'Affiliation': 'Division of Clinical Oncology, Ospedale di Sondalo, Sondrio, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Borra', 'Affiliation': 'Division of Clinical Oncology, AOU Maggiore della Carità, Novara, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schena', 'Affiliation': 'Division of Clinical Oncology I, AOU Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morabito', 'Affiliation': 'Division of Clinical Oncology and Thoracic Pneumology, IRCCS Fondazione Pascale, Naples, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Santo', 'Affiliation': 'Complex Operative Unit of Oncology - Gruppo Interdisciplinare Veronese Oncologia Polmonare (GIVOP), Verona, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gregorc', 'Affiliation': 'Division of Clinical Oncology, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chiari', 'Affiliation': 'Division of Clinical Oncology, Azienda Ospedaliera di Perugia, Ospedale Santa Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Oncology Department, LungenClinic Grosshansdorf, Grosshansdorf, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schmid-Bindert', 'Affiliation': 'Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Folprecht', 'Affiliation': 'University Hospital Carl Gustav Carus Medical Department I Dresden, Dresden, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Griesinger', 'Affiliation': 'Clinic for Haematology and Oncoloy, Medizinischer Campus Universität Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Follador', 'Affiliation': 'Department of Oncology, Presidio Ospedaliero Universitario Santa Maria della Misericordia, Azienda Sanitaria Universitaria Integrata Friuli Centrale, Udine, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pedrazzoli', 'Affiliation': 'Oncology Division, University Hospital Santa Maria della Misericordia AOU Friuli Centrale, Udine, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bearz', 'Affiliation': 'Division of Clinical Oncology, Centro di Riferimento Oncologico, Aviano, Italy.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Caffo', 'Affiliation': 'Division of Clinical Oncology, Ospedale Santa Chiara, Trento, Italy.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Dickgreber', 'Affiliation': 'Department for Respiratory Medicine and Thoracic Oncology, Klinikum Rheine - Mathias-Spital, Rheine, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Irtelli', 'Affiliation': 'Oncology Clinic, Policlinico SS. Annunziata, Chieti, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wiest', 'Affiliation': 'Asklepios Cancer Center Hamburg, Asklepios Klinikum Harburg, Hamburg, Harburg, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Monica', 'Affiliation': 'Department of Oncology at San Luigi Hospital, University of Torino, Orbassano (Torino), Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Porcu', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Oncology Department at Instituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Manegold', 'Affiliation': 'Department of Surgery, University Medical Center Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Scagliotti', 'Affiliation': 'Department of Oncology at San Luigi Hospital, University of Torino, Orbassano (Torino), Italy.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.09.017']
1065,34628013,Polypharmacy in Palliative Care for Advanced Heart Failure: The PAL-HF Experience.,"BACKGROUND


Palliative care (PC) in advanced heart failure (HF) aims to improve symptoms and quality of life (QOL), in part through medication management. The impact of PC on polypharmacy (>5 medications) remains unknown.
METHODS AND RESULTS


We explored patterns of polypharmacy in the Palliative Care in HF (PAL-HF) randomized controlled trial of standard care vs interdisciplinary PC in advanced HF (N = 150). We describe differences in medication counts between arms at 2, 6, 12, and 24 weeks for HF (12 classes) and PC (6 classes) medications. General linear mixed models were used to evaluate associations between treatment arm and polypharmacy over time. The median age of the patients was 72 years (interquartile range 62-80 years), 47% were female, and 41% were Black. Overall, 48% had ischemic etiology, and 55% had an ejection fraction of 40% or less. Polypharmacy was present at baseline in 100% of patients. HF and PC medication counts increased in both arms, with no significant differences in counts by drug class at any time point between arms.
CONCLUSIONS


In a trial of patients with advanced HF considered eligible for PC, polypharmacy was universal at baseline and increased during follow-up with no effect of the palliative intervention on medication counts relative to standard care.",2022,"HF and PC medication counts increased in both arms, with no significant differences in counts by drug class at any time-point between arms.
","['The median age of the patients was 72 (62-80) years, and 47% were female while 41% were Black', 'Advanced Heart Failure', 'We explored patterns of polypharmacy in the Palliative Care in HF (PAL-HF) randomized controlled trial of standard care versus interdisciplinary PC in advanced HF (N=150']",[],"['HF and PC medication counts', 'symptoms and quality of life (QOL', 'medication counts', 'ischemic etiology']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}]",[],"[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]",,0.190934,"HF and PC medication counts increased in both arms, with no significant differences in counts by drug class at any time-point between arms.
","[{'ForeName': 'Bradi B', 'Initials': 'BB', 'LastName': 'Granger', 'Affiliation': 'School of Nursing, Duke University, Durham, North Carolina; Margolis Center for Health Policy, Duke University, Durham, North Carolina. Electronic address: bradi.granger@dm.duke.edu.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Tulsky', 'Affiliation': ""Dana-Farber Institute, Harvard Medical School, Boston, Massachusetts; Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Brystana G', 'Initials': 'BG', 'LastName': 'Kaufman', 'Affiliation': 'Margolis Center for Health Policy, Duke University, Durham, North Carolina; Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Clare', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Chetan B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fiuzat', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steinhauser', 'Affiliation': 'Margolis Center for Health Policy, Duke University, Durham, North Carolina.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'connor"", 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Rogers', 'Affiliation': 'Texas Heart Institute, Houston, Texas.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Texas Heart Institute, Houston, Texas.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2021.08.021']
1066,34633168,Ketamine versus magnesium sulphate as an adjuvant to local anesthetics in the peribulbar block for posterior segment surgeries: a randomized controlled study.,"BACKGROUND


The use of an adjuvant to local anesthetics in the peribulbar block may improve block characteristics. The aim of this double-blinded, parallel-group, randomized, controlled trial was to evaluate the safety and efficacy of ketamine versus magnesium sulphate as adjuvants to the local anesthetic mixture of peribulbar block in patients scheduled for vitreoretinal surgeries.
METHODS


A total of 126 patients scheduled for vitreoretinal surgery were randomly allocated as either ketamine (GK, N.=42), magnesium sulphate (GM, N.=42), or control (GC, N.=42) groups. The primary outcomes were the onset and duration of globe akinesia, duration of lid akinesia, and onset of sensory block. Secondary outcomes included time to start surgery, duration of analgesia, intraocular pressure, and patient and surgeon satisfaction.
RESULTS


The use of either ketamine or magnesium significantly shortened the onset of globe akinesia, enhanced the onset of sensory block, prolonged the duration of globe and lid akinesia, minimized the time required to start surgery, and increased the total analgesic time. The effect of magnesium was significantly more pronounced on durations of globe and lid akinesia as well as analgesia, whereas ketamine significantly shortened the time required to start surgery. Both patient and surgeon satisfaction were significantly improved with the use of either drug.
CONCLUSIONS


In vitreoretinal surgeries the use of either ketamine or magnesium sulphate as adjuvants to the local anesthetic mixture of peribulbar block improved the onset, duration, and quality of the block, offered better patient and surgeon satisfaction, and was not associated with drug adverse effects or surgical complications.",2022,"The use of either ketamine or magnesium significantly shortened the onset of globe akinesia, enhanced the onset of sensory block, prolonged the duration of globe and lid akinesia, minimized the time required to start surgery, and increased the total analgesic time.","['126 patients scheduled for vitreoretinal surgery', 'patients scheduled for vitreoretinal surgeries', 'posterior segment surgeries']","['magnesium sulphate', 'ketamine', 'ketamine (GK', 'Ketamine', 'magnesium sulphate (GM, n=42), or control (GC', 'ketamine or magnesium sulphate', 'magnesium', 'ketamine or magnesium']","['onset of sensory block, prolonged the duration of globe and lid akinesia, minimized the time required to start surgery', 'durations of globe and lid akinesia', 'safety and efficacy', 'total analgesic time', 'onset of globe akinesia', 'onset and duration of globe akinesia, duration of lid akinesia, and onset of sensory block', 'time to start surgery, duration of analgesia, intraocular pressure, and patient and surgeon satisfaction', 'surgeon satisfaction', 'onset, duration, and quality of the block, offered better patient and surgeon satisfaction']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C2936205', 'cui_str': 'Vitreoretinal Surgery'}, {'cui': 'C0348015', 'cui_str': 'Posterior segment'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}]","[{'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0085623', 'cui_str': 'Akinesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]",126.0,0.397059,"The use of either ketamine or magnesium significantly shortened the onset of globe akinesia, enhanced the onset of sensory block, prolonged the duration of globe and lid akinesia, minimized the time required to start surgery, and increased the total analgesic time.","[{'ForeName': 'Tamer M', 'Initials': 'TM', 'LastName': 'Kheir', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, University of Cairo, Cairo, Egypt.'}, {'ForeName': 'Eslam M', 'Initials': 'EM', 'LastName': 'Saleh', 'Affiliation': 'Department of Anesthesia, Research Institute of Ophthalmology, Giza, Egypt - esaleh67@gmail.com.'}, {'ForeName': 'Rehab S', 'Initials': 'RS', 'LastName': 'Khattab', 'Affiliation': 'Department of Anesthesia, Research Institute of Ophthalmology, Giza, Egypt.'}, {'ForeName': 'Nader N', 'Initials': 'NN', 'LastName': 'Naguib', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, University of Cairo, Cairo, Egypt.'}]",Minerva anestesiologica,['10.23736/S0375-9393.21.15730-X']
1067,34636899,"Sustained Efficacy and Safety of Burosumab, a Monoclonal Antibody to FGF23, in Children With X-Linked Hypophosphatemia.","PURPOSE


In X-linked hypophosphatemia (XLH), excess fibroblast growth factor-23 causes hypophosphatemia and low calcitriol, leading to musculoskeletal disease with clinical consequences. XLH treatment options include conventional oral phosphate with active vitamin D, or monotherapy with burosumab, a monoclonal antibody approved to treat children and adults with XLH. We have previously reported outcomes up to 64 weeks, and here we report safety and efficacy follow-up results up to 160 weeks from an open-label, multicenter, randomized, dose-finding trial of burosumab for 5- to 12-year-old children with XLH.
METHODS


After 1 week of conventional therapy washout, patients were randomized 1:1 to burosumab every 2 weeks (Q2W) or every 4 weeks (Q4W) for 64 weeks, with dosing titrated based on fasting serum phosphorus levels between baseline and week 16. From week 66 to week 160, all patients received Q2W burosumab.
RESULTS


Twenty-six children were randomized initially into each Q2W and Q4W group and all completed treatment to week 160. In 41 children with open distal femoral and proximal tibial growth plates (from both treatment groups), total Rickets Severity Score significantly decreased by 0.9 ± 0.1 (least squares mean ± SE; P < 0.0001) from baseline to week 160. Fasting serum phosphorus increases were sustained by burosumab therapy throughout the study, with an overall population mean (SD) of 3.35 (0.39) mg/dL, within the pediatric normal range (3.2-6.1 mg/dL) at week 160 (mean change from baseline P < 0.0001). Most adverse events were mild to moderate in severity.
MAIN CONCLUSIONS


In children with XLH, burosumab administration for 160 weeks improved phosphate homeostasis and rickets and was well-tolerated. Long-term safety was consistent with the reported safety profile of burosumab.
CLINICALTRIALS.GOV


NCT02163577.",2022,"In children with XLH, burosumab administration for 160 weeks improved phosphate homeostasis and rickets and was welltolerated.","['children and adults with XLH', '41 children with open distal femoral and proximal tibial growth plates', 'children with X-linked hypophosphatemia', 'Twenty-six children', '5 to 12 year-old children with XLH']","['Q2W and Q4W', 'XLH']","['Fasting serum phosphorus', 'phosphate homeostasis and rickets', 'total Rickets Severity Score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0733682', 'cui_str': 'Hypophosphatemic Rickets, X-Linked Dominant'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0018283', 'cui_str': 'Structure of epiphyseal plate'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0733682', 'cui_str': 'Hypophosphatemic Rickets, X-Linked Dominant'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0035579', 'cui_str': 'Rickets'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",41.0,0.100478,"In children with XLH, burosumab administration for 160 weeks improved phosphate homeostasis and rickets and was welltolerated.","[{'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Linglart', 'Affiliation': 'AP-HP, Endocrinology and Diabetes for Children, Reference Center for Rare Disorders of the Calcium and Phosphate Metabolism, and Filière OSCAR, Bicêtre Paris Saclay Hospital, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Imel', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Whyte', 'Affiliation': 'Shriners Hospitals for Children - St. Louis, MO, USA.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Portale', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Högler', 'Affiliation': 'Johannes Kepler University Linz, Linz, Austria.'}, {'ForeName': 'Annemieke M', 'Initials': 'AM', 'LastName': 'Boot', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Padidela', 'Affiliation': ""Royal Manchester Children's Hospital and Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': ""Van't Hoff"", 'Affiliation': 'Great Ormond Street Hospital, London, UK.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Gottesman', 'Affiliation': 'Shriners Hospitals for Children - St. Louis, St Louis, MO, USA.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., Novato, CA, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Skrinar', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., Novato, CA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Scott Roberts', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., Novato, CA, USA.'}, {'ForeName': 'Thomas O', 'Initials': 'TO', 'LastName': 'Carpenter', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab729']
1068,34621044,Efficacy and safety of cabozantinib for patients with advanced hepatocellular carcinoma based on albumin-bilirubin grade.,"BACKGROUND


Albumin-bilirubin (ALBI) grade is an objective measure of liver function for patients with hepatocellular carcinoma (HCC). The tyrosine kinase inhibitor cabozantinib is approved for patients with advanced HCC who have received prior sorafenib based on the phase 3 CELESTIAL trial (NCT01908426). Cabozantinib improved overall survival (OS) and progression-free survival (PFS) versus placebo in patients with previously treated HCC.
METHODS


Patients were randomised 2:1 to receive cabozantinib 60 mg or placebo orally every day. Clinical outcomes in patients with ALBI grade 1 or 2 at baseline were evaluated in CELESTIAL. ALBI scores were retrospectively calculated based on baseline serum albumin and total bilirubin, with an ALBI grade of 1 defined as  ≤ -2.60 score and a grade of 2 as a score of > -2.60 to  ≤ -1.39.
RESULTS


Cabozantinib improved OS and PFS versus placebo in both ALBI grade 1 (hazard ratio [HR] [95% CI]: 0.63 [0.46-0.86] and 0.42 [0.32-0.56]) and ALBI grade 2 (HR [95% CI]: 0.84 [0.66-1.06] and 0.46 [0.37-0.58]) subgroups. Adverse events were consistent with those in the overall population. Rates of grade 3/4 adverse events associated with hepatic decompensation were generally low and were more common among patients in the ALBI grade 2 subgroup.
DISCUSSION


These results provide initial support of cabozantinib in patients with advanced HCC irrespective of ALBI grade 1 or 2.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov number, NCT01908426.",2022,"Cabozantinib improved overall survival (OS) and progression-free survival (PFS) versus placebo in patients with previously treated HCC.
","['patients with advanced HCC who have received prior', 'patients with previously treated HCC', 'patients with advanced HCC irrespective of ALBI grade 1 or 2', 'patients with ALBI grade 1 or 2 at baseline', 'Patients', 'patients with hepatocellular carcinoma (HCC', 'patients with advanced hepatocellular carcinoma based on albumin-bilirubin grade']","['sorafenib', 'cabozantinib', 'cabozantinib 60\u2009mg or placebo', 'Albumin-bilirubin ', 'placebo']","['hepatic decompensation', 'ALBI scores', 'liver function', 'OS and PFS', 'Efficacy and safety', 'overall survival (OS) and progression-free survival (PFS', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C4237943', 'cui_str': 'cabozantinib 60 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}]","[{'cui': 'C1394798', 'cui_str': 'Hepatic decompensation'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.440198,"Cabozantinib improved overall survival (OS) and progression-free survival (PFS) versus placebo in patients with previously treated HCC.
","[{'ForeName': 'Robin Kate', 'Initials': 'RK', 'LastName': 'Kelley', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA. katie.kelley@ucsf.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Miksad', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Cicin', 'Affiliation': 'Trakya University, Edirne, Turkey.'}, {'ForeName': 'YenHsun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Klümpen', 'Affiliation': 'Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Centre Hospitalier Régional Universitaire de Besançon, Besançon, France.'}, {'ForeName': 'Zhong-Zhe', 'Initials': 'ZZ', 'LastName': 'Lin', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Youkstetter', 'Affiliation': 'Exelixis, Inc, Alameda, CA, USA.'}, {'ForeName': 'Saswati', 'Initials': 'S', 'LastName': 'Hazra', 'Affiliation': 'Exelixis, Inc, Alameda, CA, USA.'}, {'ForeName': 'Suvajit', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Exelixis, Inc, Alameda, CA, USA.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Royal Free Hospital, University College London, London, UK.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",British journal of cancer,['10.1038/s41416-021-01532-5']
1069,34635802,"The efficacy and safety of zolpidem and zopiclone to treat insomnia in Alzheimer's disease: a randomized, triple-blind, placebo-controlled trial.","No prior studies have evaluated the efficacy and safety of zolpidem and zopiclone to treat insomnia of demented patients. This randomized, triple-blind, placebo-controlled clinical trial used these drugs to treat patients with probable, late onset Alzheimer's dementia (AD) (DSM V and NINCDS-ADRDA criteria) exhibiting insomnia (DSM V criteria and nocturnal NPI scores ≥ 2). Actigraphic records were performed for 7 days at baseline and for 14 days during the treatment period in 62 patients aged 80.5 years in average and randomized at a 1:1:1 ratio for administration of zolpidem 10 mg/day, zopiclone 7.5 mg/day or placebo. Primary endpoint was the main nocturnal sleep duration (MNSD), whereas secondary outcomes were the proportion of the night time slept, awake time after sleep onset (WASO), nocturnal awakenings, total daytime sleep time and daytime naps. Cognitive and functional domains were tested before and after drug/placebo use. Three participants under zopiclone use had intervention interrupted due to intense daytime sedation and worsened agitation with wandering. Zopiclone produced an 81 min increase in MNSD (95% confidence interval (CI): -0.8, 163.2), a 26 min reduction in WASO (95% CI: -56.2, 4.8) and a 2-episode decrease in awakening per night (95% CI: -4.0, 0.4) in average compared to placebo. Zolpidem yielded no significant difference in MNSD despite a significant 22 min reduction in WASO (95% CI: -52.5, 8.3) and a reduction of 1 awakening each night (95% CI: -3.4, 1.2) in relation to placebo. There was a 1-point reduction in mean performance in the symbols search test among zolpidem users (95% CI: -4.1, 1.5) and an almost eight-point reduction in average scores in the digit-symbol coding test among zopiclone users (95% CI: -21.7, 6.2). In summary, short-term use of zolpidem or zopiclone by older insomniacs with AD appears to be clinically helpful, even though safety and tolerance remain issues to be personalized in healthcare settings and further investigated in subsequent trials. This trial was registered in ClinicalTrials.gov Identifier: NCT03075241.",2022,"Zolpidem yielded no significant difference in MNSD despite a significant 22 min reduction in WASO (95% CI: -52.5, 8.3) and a reduction of 1 awakening each night (95% CI: -3.4, 1.2) in relation to placebo.","['demented patients', ""Alzheimer's disease"", ""patients with probable, late onset Alzheimer's dementia (AD) (DSM V and NINCDS-ADRDA criteria) exhibiting insomnia (DSM V criteria and nocturnal NPI scores\u2009≥\u20092"", '62 patients aged 80.5 years in average']","['zolpidem and zopiclone', 'zolpidem', 'zolpidem 10\u2009mg/day, zopiclone 7.5\u2009mg/day or placebo', 'placebo', 'Zolpidem']","['mean performance', 'MNSD', 'efficacy and safety', 'Cognitive and functional domains', 'WASO', 'main nocturnal sleep duration (MNSD', 'proportion of the night time slept, awake time after sleep onset (WASO), nocturnal awakenings, total daytime sleep time and daytime naps']","[{'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C0078847', 'cui_str': 'zopiclone'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1128536', 'cui_str': 'zopiclone 7.5 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0860510', 'cui_str': 'Nocturnal awakening'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4075948', 'cui_str': 'Sleeps during day'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}]",62.0,0.484574,"Zolpidem yielded no significant difference in MNSD despite a significant 22 min reduction in WASO (95% CI: -52.5, 8.3) and a reduction of 1 awakening each night (95% CI: -3.4, 1.2) in relation to placebo.","[{'ForeName': 'Luciana L', 'Initials': 'LL', 'LastName': 'Louzada', 'Affiliation': 'Graduation Program in Medical Sciences, University of Brasilia, Campus Universitário Darcy Ribeiro, Brasília, DF, 70910-900, Brazil. lucianaelouzada@gmail.com.'}, {'ForeName': 'Flávio V', 'Initials': 'FV', 'LastName': 'Machado', 'Affiliation': 'Graduation Program in Medical Sciences, University of Brasilia, Campus Universitário Darcy Ribeiro, Brasília, DF, 70910-900, Brazil.'}, {'ForeName': 'Juliana L', 'Initials': 'JL', 'LastName': 'Quintas', 'Affiliation': 'Graduation Program in Medical Sciences, University of Brasilia, Campus Universitário Darcy Ribeiro, Brasília, DF, 70910-900, Brazil.'}, {'ForeName': 'Guilherme A', 'Initials': 'GA', 'LastName': 'Ribeiro', 'Affiliation': 'Health Sciences Faculty, University of Brasilia, Campus Universitário Darcy Ribeiro, Brasília, DF, 70910-900, Brazil.'}, {'ForeName': 'Mônica V', 'Initials': 'MV', 'LastName': 'Silva', 'Affiliation': 'Health Sciences Faculty, University of Brasilia, Campus Universitário Darcy Ribeiro, Brasília, DF, 70910-900, Brazil.'}, {'ForeName': 'Dayde L', 'Initials': 'DL', 'LastName': 'Mendonça-Silva', 'Affiliation': 'Health Sciences Faculty, University of Brasilia, Campus Universitário Darcy Ribeiro, Brasília, DF, 70910-900, Brazil.'}, {'ForeName': 'Bruno S B', 'Initials': 'BSB', 'LastName': 'Gonçalves', 'Affiliation': 'Multidisciplinary Geriatric Center, Brasília University Hospital, SGAN 605 Av. L2 Norte, Brasilia, DF, 70840-901, Brazil.'}, {'ForeName': 'Otávio T', 'Initials': 'OT', 'LastName': 'Nóbrega', 'Affiliation': 'Graduation Program in Medical Sciences, University of Brasilia, Campus Universitário Darcy Ribeiro, Brasília, DF, 70910-900, Brazil.'}, {'ForeName': 'Einstein F', 'Initials': 'EF', 'LastName': 'Camargos', 'Affiliation': 'Graduation Program in Medical Sciences, University of Brasilia, Campus Universitário Darcy Ribeiro, Brasília, DF, 70910-900, Brazil.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-01191-3']
1070,34954841,"Secukinumab demonstrates efficacy, safety, and tolerability upon administration by 2 ml autoinjector in adult patients with plaque psoriasis: 52-week results from MATURE, a randomized, placebo-controlled trial.","Convenient administration is an important factor for treatment adherence in patients with psoriasis. MATURE study reports the efficacy, safety, tolerability, and pharmacokinetics (PKs) of secukinumab 300 mg 2 ml autoinjector (AI) from MATURE trial (NCT03589885). Eligible patients were randomized to secukinumab 300 mg 2 ml AI or 2× 1 ml prefilled syringe (PFS) or placebo. The co-primary endpoints were psoriasis area and severity index (PASI) 75 and investigator's global assessment (IGA) 0/1 response rates at Week 12 versus placebo. Other endpoints included PASI90/100 response, dermatology life quality index (DLQI) 0/1, PKs, 2 ml AI usability rated using self-injection assessment questionnaire (SIAQ), and safety. The study met both co-primary and secondary endpoints (p < 0.0001). Secukinumab 300 mg 2 ml AI and 2× 1 ml PFS treatments led to superior PASI75/90/100 (2 ml AI: 95.1%/75.6%/43.9%; 2× 1 mL PFS: 83.2%/62.6%/37.5% and placebo: 10%/5.0%/0.0%, respectively), IGA, and DLQI 0/1 responses compared with placebo, and efficacy was sustained through 52 weeks. SIAQ results showed high usability of self-injection with 2 mL AI device. No new safety signals were observed. Study design may bias the interpretation of safety profile after Week 12, due to different exposure of secukinumab versus placebo. Secukinumab 300 mg administered with the 2 mL AI demonstrated superior efficacy over placebo, good tolerability, and convenient administration.",2022,"Secukinumab 300 mg administered with the 2 mL AI demonstrated superior efficacy over placebo, good tolerability, and convenient administration.","['patients with psoriasis', 'Eligible patients', 'adult patients with plaque psoriasis']","['placebo', 'secukinumab 300\u2009mg 2', 'Secukinumab 300\u2009mg 2\u2009ml AI', 'secukinumab versus placebo', 'secukinumab 300\u2009mg 2\xa0ml AI or 2×', 'Secukinumab', 'ml prefilled syringe (PFS) or placebo']","['AI usability rated using self-injection assessment questionnaire (SIAQ), and safety', ""psoriasis area and severity index (PASI) 75 and investigator's global assessment (IGA) 0/1 response rates"", 'efficacy, safety, tolerability, and pharmacokinetics (PKs', 'PASI90/100 response, dermatology life quality index (DLQI) 0/1, PKs', 'efficacy, safety, and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}]","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}]",,0.46174,"Secukinumab 300 mg administered with the 2 mL AI demonstrated superior efficacy over placebo, good tolerability, and convenient administration.","[{'ForeName': 'Bardur', 'Initials': 'B', 'LastName': 'Sigurgeirsson', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, University of Iceland, Reykjavík, Iceland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Browning', 'Affiliation': 'Department of Dermatology, University of Texas Health Science Center San Antonio, Texas, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Tyring', 'Affiliation': 'Center for Clinical Studies, Houston, Texas, USA.'}, {'ForeName': 'Jacek C', 'Initials': 'JC', 'LastName': 'Szepietowski', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Rivera-Díaz', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Isaak', 'Initials': 'I', 'LastName': 'Effendy', 'Affiliation': 'Departrment of Dermatology and Allergology, University Hospital of Bielefeld, Bielefeld, Germany.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Keefe', 'Affiliation': 'Immunology, Hepatology and Dermatology (IH&D), Novartis Pharmaceuticals Corporation, New Jersey, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Bruin', 'Affiliation': 'Immunology, Hepatology and Dermatology (IH&D), Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Paguet', 'Affiliation': 'Immunology, Hepatology and Dermatology (IH&D), Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Fu', 'Affiliation': 'Analytics, Immunology, Hepatology and Dermatology (IH&D), Novartis Institutes of for Biomedical Research, Shanghai, China.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Hampele', 'Affiliation': 'Immunology, Hepatology and Dermatology (IH&D), Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Reinhardt', 'Affiliation': 'Immunology, Hepatology and Dermatology (IH&D), Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Manmath', 'Initials': 'M', 'LastName': 'Patekar', 'Affiliation': 'Immunology, Hepatology and Dermatology (IH&D), Novartis Pharma AG, Basel, Switzerland.'}]",Dermatologic therapy,['10.1111/dth.15285']
1071,34630560,Associated Mirror Therapy Enhances Motor Recovery of the Upper Extremity and Daily Function after Stroke: A Randomized Control Study.,"Bimanual cooperation plays a vital role in functions of the upper extremity and daily activities. Based on the principle of bilateral movement, mirror therapy could provide bimanual cooperation training. However, conventional mirror therapy could not achieve the isolation of the mirror. A novel paradigm mirror therapy called associated mirror therapy (AMT) was proposed to achieve bimanual cooperation task-based mirror visual feedback isolating from the mirror. The study was aimed at exploring the feasibility and effectiveness of AMT on stroke patients. We conducted a single-blind, randomized controlled trial. Thirty-six eligible patients were equally assigned into the experimental group (EG) receiving AMT and the control group (CG) receiving bimanual training without mirroring for five days/week, lasting four weeks. The Fugl-Meyer Assessment Upper Limb subscale (FMA-UL) for upper extremity motor impairment was used as the primary outcome. The secondary outcomes were the Box and Block Test (BBT) and Functional Independence Measure (FIM) for motor and daily function. All patients participated in trials throughout without adverse events or side effects. The scores of FMA-UL and FIM improved significantly in both groups following the intervention. Compared to CG, the scores of FMA-UL and FIM were improved more significantly in EG after the intervention. The BBT scores were improved significantly for EG following the intervention, but no differences were found in the BBT scores of CG after the intervention. However, no differences in BBT scores were observed between the two groups. In summary, our study suggested that AMT was a feasible and practical approach to enhance the motor recovery of paretic arms and daily function in stroke patients. Furthermore, AMT may improve manual dexterity for poststroke rehabilitation.",2021,"Compared to CG, the scores of FMA-UL and FIM were improved more significantly in EG after the intervention.","['stroke patients', 'Thirty-six eligible patients']","['novel paradigm mirror therapy called associated mirror therapy (AMT', 'AMT', 'conventional mirror therapy', 'AMT and the control group (CG) receiving bimanual training without mirroring']","['BBT scores of CG', 'Fugl-Meyer Assessment Upper Limb subscale (FMA-UL', 'Box and Block Test (BBT) and Functional Independence Measure (FIM) for motor and daily function', 'scores of FMA-UL and FIM', 'BBT scores']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319606', 'cui_str': '36'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",36.0,0.0367021,"Compared to CG, the scores of FMA-UL and FIM were improved more significantly in EG after the intervention.","[{'ForeName': 'Jin-Yang', 'Initials': 'JY', 'LastName': 'Zhuang', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Bei-Bei', 'Initials': 'BB', 'LastName': 'Shu', 'Affiliation': ""Department of Rehabilitation Medicine, Shanghai Jing'an District Central Hospital, Shanghai, China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Rehabilitation Medicine, Shanghai Jing'an District Central Hospital, Shanghai, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}]",Neural plasticity,['10.1155/2021/7266263']
1072,34634436,Impact of Dose-Escalated Chemoradiation on Quality of Life in Patients With Locally Advanced Rectal Cancer: 2-Year Follow-Up of the Randomized RECTAL-BOOST Trial.,"PURPOSE


Dose-escalated chemoradiation (CRT) for locally advanced rectal cancer did not result in higher complete response rates but initiated more tumor regression in the randomized RECTAL-BOOST trial (Clinicaltrials.gov NCT01951521). This study compared patient reported outcomes between patients who received dose-escalated CRT (5 × 3 gray boost + CRT) or standard CRT for 2 years after randomization.
METHODS AND MATERIALS


Patients with locally advanced rectal cancer who were participating in the RECTAL-BOOST trial filled out European Organisation for Research and Treatment of Cancer QLQ-C30 and CR29 questionnaires on quality of life (QoL) and symptoms at baseline, 3, 6, 12, 18, and 24 months after start of treatment. Between-group differences in functional QoL domains were estimated using a linear mixed-effects model and expressed as effect size (ES). Symptom scores were compared using Mann-Whitney U test.
RESULTS


Patients treated with dose-escalated CRT (boost group, n = 51) experienced a significantly stronger decline in global health at 3 and 6 months (ES -0.4 and ES -0.4), physical functioning at 6 months (ES -1.1), role functioning at 3 and 6 months (ES -0.8 and ES -0.6), and social functioning at 6 months (ES -0.6), compared with patients treated with standard CRT (control group, n = 64). The boost group reported significantly more fatigue at 3 and 6 months (83% vs 66% respectively 89% vs 76%), pain at 3 and 6 months (67% vs 36% respectively 80% vs 44%), and diarrhea at 3 months (45% vs 29%) compared with the control group. From 12 months onwards, QoL and symptoms were similar between groups, apart from more blood/mucus in stool in the boost group.
CONCLUSIONS


In patients with locally advanced rectal cancer, dose-escalated CRT resulted in a transient deterioration in global health, physical, role, and social functioning and more pain, fatigue and diarrhea at 3 and 6 months after start of treatment compared with standard CRT. From 12 months onwards, the effect of dose-escalated CRT on QoL largely resolved.",2022,"From 12 months onwards, QoL and symptoms were similar between groups, apart from more blood/mucus in stool in the boost group.
","['locally advanced rectal cancer (LARC', 'Patients with LARC, participating in the XXXXX trial', 'patients with locally advanced rectal cancer']","['CRT (5\u202f×\u202f3Gy boost\u202f+\u202fCRT) or standard CRT', 'dose-escalated chemoradiation', 'filled out EORTC QLQ-C30 and CR29 questionnaires', 'CRT', 'standard CRT', 'Dose-escalated chemoradiation (CRT']","['global health, physical, role, and social functioning and more pain, fatigue and diarrhea', 'pain', 'QoL and symptoms', 'functional QoL domains', 'global health', 'fatigue', 'quality of life (QoL) and symptoms', 'diarrhea', 'social functioning', 'quality of life', 'Symptom scores']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.116329,"From 12 months onwards, QoL and symptoms were similar between groups, apart from more blood/mucus in stool in the boost group.
","[{'ForeName': 'Maaike E', 'Initials': 'ME', 'LastName': 'Verweij', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht; Department of Surgery, University Medical Center Utrecht, Utrecht. Electronic address: m.e.verweij-5@umcutrecht.nl.'}, {'ForeName': 'Sieske', 'Initials': 'S', 'LastName': 'Hoendervangers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht; Department of Surgery, University Medical Center Utrecht, Utrecht.'}, {'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Couwenberg', 'Affiliation': 'Department of Radiation Oncology, Antoni van Leeuwenhoek Ziekenhuis, Amsterdam.'}, {'ForeName': 'J P Maarten', 'Initials': 'JPM', 'LastName': 'Burbach', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, Groningen.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Berbee', 'Affiliation': 'Department of Radiation Oncology (Maastro), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Buijsen', 'Affiliation': 'Department of Radiation Oncology (Maastro), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Roodhart', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht.'}, {'ForeName': 'Onne', 'Initials': 'O', 'LastName': 'Reerink', 'Affiliation': 'Department of Radiation Oncology, Isala Clinic, Zwolle.'}, {'ForeName': 'Apollo', 'Initials': 'A', 'LastName': 'Pronk', 'Affiliation': 'Department of Surgery, Diakonessenhuis, Utrecht.'}, {'ForeName': 'Esther C J', 'Initials': 'ECJ', 'LastName': 'Consten', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, Groningen; Department of Surgery, Meander Medical Center, Amersfoort.'}, {'ForeName': 'Anke B', 'Initials': 'AB', 'LastName': 'Smits', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, Nieuwegein.'}, {'ForeName': 'Joost T', 'Initials': 'JT', 'LastName': 'Heikens', 'Affiliation': 'Department of Surgery, Hospital Rivierenland, Tiel; The Netherlands.'}, {'ForeName': 'W Helma M U', 'Initials': 'WHMU', 'LastName': 'van Grevenstein', 'Affiliation': 'Department of Surgery, University Medical Center Utrecht, Utrecht.'}, {'ForeName': 'Martijn P W', 'Initials': 'MPW', 'LastName': 'Intven', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht.'}, {'ForeName': 'H Lenny M', 'Initials': 'HLM', 'LastName': 'Verkooijen', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.09.052']
1073,34627753,Effect of a Video-Assisted Advance Care Planning Intervention on End-of-Life Health Care Transitions Among Long-Stay Nursing Home Residents.,"OBJECTIVE


To determine the relationship between an advance care planning (ACP) video intervention, Pragmatic Trial of Video Education in Nursing Homes (PROVEN), and end-of-life health care transitions among long-stay nursing home residents with advanced illness.
DESIGN


Pragmatic cluster randomized clinical trial. Five ACP videos were available on tablets or online at intervention facilities. PROVEN champions employed by nursing homes (usually social workers) were directed to offer residents (or their proxies) ≥1 video under certain circumstances. Control facilities employed usual ACP practices.
SETTING AND PARTICIPANTS


PROVEN occurred from February 2016 to May 2019 in 360 nursing homes (119 intervention, 241 control) owned by 2 health care systems. This post hoc study of PROVEN data analyzed long-stay residents ≥65 years who died during the trial who had either advanced dementia or cardiopulmonary disease (advanced illness). We required an observation time ≥90 days before death. The analytic sample included 923 and 1925 advanced illness decedents in intervention and control arms; respectively.
METHODS


Outcomes included the proportion of residents with 1 or more hospital transfer (ie, hospitalization, emergency department use, or observation stay), multiple (≥3) hospital transfers during the last 90 days of life, and late transitions (ie, hospital transfer during the last 3 days or hospice admission on the last day of life).
RESULTS


Hospital transfers in the last 90 days of life among decedents with advanced illness were significantly lower in the intervention vs control arm (proportion difference = -1.7%, 95% CI -3.2%, -0.1%). The proportion of decedents with multiple hospital transfers and late transitions did not differ between the trial arms.
CONCLUSIONS AND IMPLICATIONS


Video-assisted ACP was modestly associated with reduced hospital transfers in the last 90 days of life among nursing home residents with advanced illness. The intervention was not significantly associated with late health care transitions and multiple hospital transfers.",2022,"RESULTS


Hospital transfers in the last 90 days of life among decedents with advanced illness were significantly lower in the intervention vs control arm (proportion difference = -1.7%, 95% CI -3.2%, -0.1%).","['long-stay nursing home residents with advanced illness', 'data analyzed long-stay residents ≥65\xa0years who died during the trial who had either advanced dementia or cardiopulmonary disease (advanced illness', 'nursing homes (usually social workers', 'Long-Stay Nursing Home Residents', 'Outcomes included the proportion of residents with 1 or more hospital transfer (ie, hospitalization, emergency department use, or observation stay), multiple (≥3) hospital transfers during the last 90\xa0days of life, and late transitions (ie, hospital transfer during the last 3\xa0days or hospice admission on the last day of life', 'PROVEN occurred from February 2016 to May 2019 in 360 nursing homes (119 intervention, 241 control) owned by 2 health care systems', '923 and 1925 advanced illness decedents in intervention and control arms; respectively', 'nursing home residents with advanced illness']","['Video-Assisted Advance Care Planning Intervention', 'advance care planning (ACP) video intervention']","['End-of-Life Health Care Transitions', 'proportion of decedents with multiple hospital transfers and late transitions', 'late health care transitions and multiple hospital transfers', 'advanced illness', 'hospital transfers']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3658215', 'cui_str': 'Practical Clinical Trials'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]",5.0,0.0291325,"RESULTS


Hospital transfers in the last 90 days of life among decedents with advanced illness were significantly lower in the intervention vs control arm (proportion difference = -1.7%, 95% CI -3.2%, -0.1%).","[{'ForeName': 'Patience', 'Initials': 'P', 'LastName': 'Moyo', 'Affiliation': 'Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, RI, USA. Electronic address: patience_moyo@brown.edu.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Loomer', 'Affiliation': 'Department of Economics and Health Care Management, University of Minnesota Duluth Labovitz School of Business and Economics, Duluth, MN, USA.'}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Teno', 'Affiliation': 'Oregon Health Sciences University School of Medicine, Portland, OR, USA.'}, {'ForeName': 'Roee', 'Initials': 'R', 'LastName': 'Gutman', 'Affiliation': 'Department of Biostatistics, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'McCreedy', 'Affiliation': 'Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Bélanger', 'Affiliation': 'Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Angelo E', 'Initials': 'AE', 'LastName': 'Volandes', 'Affiliation': 'General Medicine, Harvard Medical School, Boston, MA, USA; Section of General Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Mitchell', 'Affiliation': 'Hebrew Senior Life, Hinda and Arthur Marcus Institute for Aging Research, Boston, MA, USA; Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mor', 'Affiliation': 'Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, RI, USA; Long Term Services and Supports Center of Innovation, Providence VA Medical Center, Providence, RI, USA.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2021.09.014']
1074,34633894,"Has the time come for routine use of PET/CT for guiding treatment of biochemical recurrence after radical prostatectomy? RE: JaniAB, et al.  18 F-fluciclovine-PET/CT imaging versus conventional imaging alone to guide postprostatectomy salvage radiotherapy for prostate cancer (EMPIRE-1): a single centre, open-label, phase 2/3 randomised controlled trial. Lancet. 2021 May 22;55:1895-1904.",,2021,,['2021'],"['fluciclovine-PET/CT imaging versus conventional imaging alone', 'PET/CT']",[],[],"[{'cui': 'C1311253', 'cui_str': 'fluciclovine F-18'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]",[],,0.150917,,"[{'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Bratt', 'Affiliation': 'Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Scandinavian journal of urology,['10.1080/21681805.2021.1942192']
1075,34643944,Machine learning-assisted screening for cognitive impairment in the emergency department.,"BACKGROUND/OBJECTIVES


Despite a high prevalence and association with poor outcomes, screening to identify cognitive impairment (CI) in the emergency department (ED) is uncommon. Identification of high-risk subsets of older adults is a critical challenge to expanding screening programs. We developed and evaluated an automated screening tool to identify a subset of patients at high risk for CI.
METHODS


In this secondary analysis of existing data collected for a randomized control trial, we developed machine-learning models to identify patients at higher risk of CI using only variables available in electronic health record (EHR). We used records from 1736 community-dwelling adults age > 59 being discharged from three EDs. Potential CI was determined based on the Blessed Orientation Memory Concentration (BOMC) test, administered in the ED. A nested cross-validation framework was used to evaluate machine-learning algorithms, comparing area under the receiver-operator curve (AUC) as the primary metric of performance.
RESULTS


Based on BOMC scores, 121 of 1736 (7%) participants screened positive for potential CI at the time of their ED visit. The best performing algorithm, an XGBoost model, predicted BOMC positivity with an AUC of 0.72. With a classification threshold of 0.4, this model had a sensitivity of 0.73, a specificity of 0.64, a negative predictive value of 0.97, and a positive predictive value of 0.13. In a hypothetical ED with 200 older adult visits per week, the use of this model would lead to a decrease in the in-person screening burden from 200 to 77 individuals in order to detect 10 of 14 patients who would fail a BOMC.
CONCLUSION


This study demonstrates that an algorithm based on EHR data can define a subset of patients at higher risk for CI. Incorporating such an algorithm into a screening workflow could allow screening efforts and resources to be focused where they have the most impact.",2021,"With a classification threshold of 0.4, this model had a sensitivity of 0.73, a specificity of 0.64, a negative predictive value of 0.97, and a positive predictive value of 0.13.","['1736 community-dwelling adults age\u2009>\u200959 being discharged from three EDs', 'older adults', '77 individuals in order to detect 10 of 14 patients who would fail a BOMC']",['Machine learning-assisted screening'],"['BOMC scores', 'Blessed Orientation Memory Concentration (BOMC) test']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",1736.0,0.116846,"With a classification threshold of 0.4, this model had a sensitivity of 0.73, a specificity of 0.64, a negative predictive value of 0.97, and a positive predictive value of 0.13.","[{'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Yadgir', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Collin', 'Initials': 'C', 'LastName': 'Engstrom', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Gwen Costa', 'Initials': 'GC', 'LastName': 'Jacobsohn', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Green', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Courtney M C', 'Initials': 'CMC', 'LastName': 'Jones', 'Affiliation': 'Department of Emergency Medicine, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Jeremy T', 'Initials': 'JT', 'LastName': 'Cushman', 'Affiliation': 'Department of Emergency Medicine, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Caprio', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Amy J H', 'Initials': 'AJH', 'LastName': 'Kind', 'Affiliation': 'Division of Geriatrics and Gerontology, Department of Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lohmeier', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Manish N', 'Initials': 'MN', 'LastName': 'Shah', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.17491']
1076,34643808,Treatment of intrabony periodontal defects in controlled diabetic patients with an enamel matrix derivative: a split-mouth randomized clinical trial.,"OBJECTIVE


This split-mouth randomized controlled trial aimed to evaluate the effect of enamel matrix derivative (EMD) associated with a simplified papilla preservation flap (SPPF) compared to SPPF alone in the surgical treatment of intrabony defects (ID) in type 2 diabetic mellitus (T2DM) patients.
MATERIAL AND METHODS


Thirteen patients with controlled T2DM presenting with ID in at least two quadrants were included. In each patient, the test site (TS) was treated with SPPF plus EMD, whereas the control site (CS) was treated only with SPPF. Prior to surgery and at 6 months after intervention, the following parameters were evaluated: clinical attachment level (CAL), probing pocket depth (PPD), and gingival recession (GR).
RESULTS


The TS and CS demonstrated a mean CAL gain of 3.31 ± 0.96 mm and 1.61 ± 1.12 mm, and a PPD reduction from 8.15 ± 0.98 to 3.00 ± 0.57 mm and 7.53 ± 0.96 to 4.69 ± 0.63 mm after 6 months, respectively. In both sites, the mean CAL gain and PPD reduction improved significantly after 6 months compared to baseline; however, the improvement was higher in the TS (p < 0.001).
CONCLUSIONS


Both surgical procedures presented with clinical improvements in controlled T2DM patients. However, the additional use of EMD showed enhanced clinical results after 6 months with regard to CAL gain and PPD reduction.
CLINICAL RELEVANCE


This study showed a better PPD reduction and CAL gain when an EMD was applied in addition to SPPF. Therefore, EMD may be used to enhance clinical outcomes in periodontal ID of controlled T2DM patients.",2022,"However, the additional use of EMD showed enhanced clinical results after 6 months with regard to CAL gain and PPD reduction.
","['Thirteen patients with controlled T2DM presenting with ID in at least two quadrants were included', 'type 2 diabetic mellitus (T2DM) patients', 'controlled diabetic patients with an enamel matrix derivative']","['EMD', 'simplified papilla preservation flap (SPPF', 'SPPF alone', 'enamel matrix derivative (EMD']","['clinical attachment level (CAL), probing pocket depth (PPD), and gingival recession (GR', 'PPD reduction and CAL gain', 'mean CAL gain and PPD reduction']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",13.0,0.0997058,"However, the additional use of EMD showed enhanced clinical results after 6 months with regard to CAL gain and PPD reduction.
","[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Cimões', 'Affiliation': 'Department of Prosthesis and Oral Facial Surgery, Federal University of Pernambuco, Recife, Pernambuco, Brazil. renata.silveira@ufpe.br.'}, {'ForeName': 'Leógenes M', 'Initials': 'LM', 'LastName': 'Santiago', 'Affiliation': 'Faculty of Dentistry of Caruaru, Caruaru, Pernambuco, Brazil.'}, {'ForeName': 'Arnaldo', 'Initials': 'A', 'LastName': 'de França Caldas Júnior', 'Affiliation': 'Department of Clinics and Preventive Dentistry, Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'de Carvalho Farias Vajgel', 'Affiliation': 'Department of Prosthesis and Oral Facial Surgery, Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Jeniffer', 'Initials': 'J', 'LastName': 'Perussolo', 'Affiliation': 'Centre for Oral Immunobiology & Regenerative Medicine and Centre for Oral Clinical Research, Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London (QMUL), London, UK.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Donos', 'Affiliation': 'Centre for Oral Immunobiology & Regenerative Medicine and Centre for Oral Clinical Research, Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London (QMUL), London, UK.'}]",Clinical oral investigations,['10.1007/s00784-021-04215-w']
1077,34635956,Comparison of the effect of removing bandage contact lens on the days 3 and 5 following photorefractive keratectomy.,"AIM


To compare the outcomes of removing bandage contact lens (BCL) on days 3 and 5 after photorefractive keratectomy (PRK).
METHODS


One hundred patients who underwent PRK (a total of 200 eyes) were enrolled in the present study. The subjects were assigned to two groups. Group 1 consisted of the right eyes of subjects and bandage contact lenses removal were on the 3rd day; Group 2 consisted of the fellow eyes of same subjects and removed bandage contact lenses on the 5th day after PRK. Then, data obtained from both groups were compared. To evaluate complications, the subjects underwent a slit-lamp examination in all visits.
RESULTS


Filamentary keratitis was observed in one eye in both groups. The frequency of haze was higher in group 1; however, it was not significant between the two groups. Using mixed model analysis, significant differences were observed in the rate of complications as well as pain and eye discomfort scores between the groups (P < 0.05). No major complication was reported.
CONCLUSION


Majority of post-PRK corneal epithelial defect is healed on day 3. However, keeping BCL for 5 days postoperatively instead of the three days produces a slightly lower rate of total complication.",2022,"Using mixed model analysis, significant differences were observed in the rate of complications as well as pain and eye discomfort scores between the groups (P < 0.05).",['One hundred patients who underwent PRK (a total of 200 eyes'],"['removing bandage contact lens', 'removing bandage contact lens (BCL', 'fellow eyes of same subjects and removed bandage contact lenses']","['frequency of haze', 'rate of total complication', 'pain and eye discomfort scores', 'rate of complications']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0395416', 'cui_str': 'Refractive keratoplasty by laser surgery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1562032', 'cui_str': 'Bandage contact lens'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",200.0,0.0158755,"Using mixed model analysis, significant differences were observed in the rate of complications as well as pain and eye discomfort scores between the groups (P < 0.05).","[{'ForeName': 'Seyed-Hashem', 'Initials': 'SH', 'LastName': 'Daryabari', 'Affiliation': 'Chemical Injuries Research Center, Systems Biology and Poisonings Institutes, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Khosrow', 'Initials': 'K', 'LastName': 'Jadidi', 'Affiliation': 'Bina Eye Hospital Research Center, Tehran, Iran.'}, {'ForeName': 'Seyed Aliasghar', 'Initials': 'SA', 'LastName': 'Mosavi', 'Affiliation': 'Bina Eye Hospital Research Center, Tehran, Iran. a_a_mosavi@hotmail.com.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Naderi', 'Affiliation': 'Chemical Injuries Research Center, Systems Biology and Poisonings Institutes, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}]",International ophthalmology,['10.1007/s10792-021-02029-z']
1078,34637608,"Bioequivalence and Food Effect Assessment of 2 Rivaroxaban Formulations in Healthy Chinese Volunteers: An Open, Randomized, Single-Dose, and 4-Period Crossover Study.","Rivaroxaban is a direct factor Xa inhibitor used for the management of thromboembolic disorders. The aim of this study was to evaluate the safety, pharmacokinetic profile, and bioequivalence of a generic and a branded rivaroxaban formulation (Xarelto) under fasted and fed conditions in healthy Chinese volunteers. An open-label, randomized, single-dose, 4-period complete, and replicate crossover study in healthy Chinese volunteers was performed. A single oral dose of 20 mg of 2 rivaroxaban formulations was administered to 72 healthy volunteers, with 36 in the fasted group and 36 consuming a high-fat diet. The evaluated pharmacokinetic parameters, including maximum rivaroxaban concentration, the area under the concentration-time curve (AUC) from time 0 to the last measurable concentration, and AUC from time 0 to infinity, were assessed for BE. The plasma concentrations of rivaroxaban were measured by a validated liquid chromatography-tandem mass spectrometry method. The geometric mean ratios with 90% confidence intervals of the maximum rivaroxaban concentration, AUC from time 0 to the last measurable concentration, and AUC from time 0 to infinity were all within the range of 80% to 125% under fasted and fed conditions. The within-subject variability of the test and reference products was compared, and the upper limit of the 90% confidence intervals for the test-to-reference ratio of the within-subject variability was <2.5, which indicated that the rivaroxaban test and the rivaroxaban reference formulation were bioequivalent. No serious adverse events were reported during either fasted or fed conditions of the study.",2022,No serious adverse events were reported during either fasted or fed conditions of the study.,"['Healthy Chinese Volunteers', '72 healthy volunteers, with 36 in the fasted group and 36 consuming a high-fat diet', 'healthy Chinese volunteers']","['Rivaroxaban Formulations', 'rivaroxaban formulations', 'branded rivaroxaban formulation (Xarelto', 'Rivaroxaban', 'Xa inhibitor']","['plasma concentrations of rivaroxaban', 'maximum rivaroxaban concentration, the area under the concentration-time curve (AUC', 'geometric mean ratios', 'serious adverse events']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C3159309', 'cui_str': 'Xarelto'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",72.0,0.0322632,No serious adverse events were reported during either fasted or fed conditions of the study.,"[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Phase I Clinical Research Center, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Phase I Clinical Research Center, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Shi', 'Affiliation': 'Phase I Clinical Research Center, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Research Center, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': 'Phase I Clinical Research Center, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Shuqin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Research Center, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Phase I Clinical Research Center, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xiaomeng', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Phase I Clinical Research Center, the Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Phase I Clinical Research Center, the Affiliated Hospital of Qingdao University, Qingdao, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.1031']
1079,34643807,Fatigue behavior and stress distribution of molars restored with MOD inlays with and without deep margin elevation.,"OBJECTIVES


This study evaluated the effect of deep margin elevation (DME) and restorative materials (leucite-reinforced glass-ceramics [C] vs. indirect resin composite [R]) on the fatigue behavior and stress distribution of maxillary molars with 2-mm deep proximal margins restored with MOD inlay.
METHODS


Fifty-two extracted human third molars were randomly assigned into four groups (n = 13): C; DME + C; R; and DME + R. Inlays were fabricated in CAD-CAM and bonded to all teeth. The fatigue behavior was assessed with the stepwise stress test (10,000 cycles/step; step = 50 N; 20 Hz; initial load = 200 N). Fatigue failure loads and the number of cycles were analyzed with 2-way ANOVA and Tukey's test (p < 0.05) and Kaplan-Meier survival plots. The stress distribution was assessed with finite element analysis. The models were considered isotropic, linear, and homogeneous, and presented bonded contacts. A tripod axial load (400 N) was applied to the occlusal surface. The stress distribution was analyzed with the maximum principal stress criterion.
RESULTS


For fatigue, there was no difference for DME factor (p > 0.05). For the material factor, the load and number of cycles for failure were statistically higher in the R groups (p < 0.05). The finite element analysis showed that resin composite inlays concentrated more stress in the tooth structure, while ceramic inlays concentrated more stress in the restoration. Non-reparable failures were more frequent in the resin composite inlays groups.
CONCLUSIONS


DME was not negative for fatigue and biomechanical behaviors. Resin composite inlays were more resistant to the fatigue test, although the failure mode was more aggressive.
CLINICAL SIGNIFICANCE


DME does not impair mechanical behavior. Resin composite inlays failed at higher loads but with a more aggressive failure mode.",2022,"For the material factor, the load and number of cycles for failure were statistically higher in the R groups (p < 0.05).","['Fifty-two extracted human third molars were randomly assigned into four groups (n\u2009=\u200913', 'maxillary molars with 2-mm deep proximal margins restored with MOD inlay']","['DME', 'deep margin elevation (DME) and restorative materials (leucite-reinforced glass-ceramics [C] vs. indirect resin composite [R']","['Fatigue behavior and stress distribution', 'fatigue behavior', 'DME factor', 'load and number of cycles for failure', 'Fatigue failure loads and the number of cycles', 'stress distribution']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C0211161', 'cui_str': 'leucite'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",52.0,0.108248,"For the material factor, the load and number of cycles for failure were statistically higher in the R groups (p < 0.05).","[{'ForeName': 'Elisa Donaria Aboucauch', 'Initials': 'EDA', 'LastName': 'Grassi', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Institute of Science and Technology, São Paulo State University (Unesp), 777th Eng. Francisco José Longo Av., São José dos Campos, SP, 12245-000, Brazil.'}, {'ForeName': 'Guilherme Schmitt', 'Initials': 'GS', 'LastName': 'de Andrade', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Institute of Science and Technology, São Paulo State University (Unesp), 777th Eng. Francisco José Longo Av., São José dos Campos, SP, 12245-000, Brazil.'}, {'ForeName': 'João Paulo Mendes', 'Initials': 'JPM', 'LastName': 'Tribst', 'Affiliation': 'Post-Graduate Program in Dentistry, University of Taubaté (UNITAU), 09th Rua Dos Operários St., Taubaté, SP, 12020-340, Brazil.'}, {'ForeName': 'Renan Vaz', 'Initials': 'RV', 'LastName': 'Machry', 'Affiliation': 'Graduate Program of Oral Science, Prosthodontics Unit, School of Dentistry, Federal University of Santa Maria (UFSM), Roraima Av, Santa Maria, RS, 100097105-340, Brazil.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Graduate Program of Oral Science, Prosthodontics Unit, School of Dentistry, Federal University of Santa Maria (UFSM), Roraima Av, Santa Maria, RS, 100097105-340, Brazil.'}, {'ForeName': 'Nathalia de Carvalho', 'Initials': 'NC', 'LastName': 'Ramos', 'Affiliation': 'School of Dentistry, São Francisco University (USF), 218th São Francisco de Assis Av., Bragança Paulista, SP, 12916-900, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bresciani', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University (Unesp), 777th Eng. Francisco José Longo Av., São José dos Campos, SP, 12245-000, Brazil.'}, {'ForeName': 'Guilherme de Siqueira Ferreira Anzaloni', 'Initials': 'GSFA', 'LastName': 'Saavedra', 'Affiliation': 'Department of Dental Materials and Prosthodontics, Institute of Science and Technology, São Paulo State University (Unesp), 777th Eng. Francisco José Longo Av., São José dos Campos, SP, 12245-000, Brazil. guilherme.saavedra@unesp.br.'}]",Clinical oral investigations,['10.1007/s00784-021-04219-6']
1080,34643736,Neural Changes in Reward Processing Following Approach Avoidance Training for Depression.,"Altered approach motivation is hypothesized to be critical for the maintenance of depression. Computer-administered approach-avoidance training programs to increase approach action tendencies toward positive stimuli produce beneficial outcomes. However, there have been few studies examining neural changes following approach-avoidance training. Participants with Major Depressive Disorder were randomized to an Approach Avoidance Training (AAT) manipulation intended to increase approach tendencies for positive social cues (n=13) or a control procedure (n=15). We examined changes in neural activation (primary outcome) and connectivity patterns using Group Iterative Multiple Model Estimation during a social reward anticipation task (exploratory). A laboratory-based social affiliation task was also administered following the manipulation to measure affect during anticipation of real-world social activity. Individuals in the AAT group demonstrated increased activation in reward processing regions during social reward anticipation relative to the control group from pre to post-training. Following training, connectivity patterns across reward regions were observed in the full sample and connectivity between the medial PFC and caudate was associated with anticipatory positive affect before the social interaction; preliminary evidence of differential connectivity patterns between the two groups also emerged. Results support models whereby modifying approach-oriented behavioral tendencies with computerized training leads to alterations in reward circuitry. (NCT02330744).",2021,Individuals in the AAT group demonstrated increased activation in reward processing regions during social reward anticipation relative to the control group from pre to post-training.,['Participants with Major Depressive Disorder'],"['Approach Avoidance Training (AAT) manipulation intended to increase approach tendencies for positive social cues (n=13) or a control procedure', 'connectivity patterns using Group Iterative Multiple Model Estimation during a social reward anticipation task (exploratory', 'Approach Avoidance Training']",['activation in reward processing regions'],"[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.0136739,Individuals in the AAT group demonstrated increased activation in reward processing regions during social reward anticipation relative to the control group from pre to post-training.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bomyea', 'Affiliation': 'VA San Diego Healthcare System, Center of Excellence for Stress and Mental Health; SanDiego, CA USA.'}, {'ForeName': 'Soo-Hee', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Psychiatry, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Sweet', 'Affiliation': 'University of California, Department of Psychiatry, San Diego, CA USA.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Stein', 'Affiliation': 'University of California, Department of Psychiatry, San Diego, CA USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Paulus', 'Affiliation': 'Laureate Institute for Brain Research; Tulsa, OK USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'University of California, Department of Psychiatry, San Diego, CA USA.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsab107']
1081,34641950,Impact of interprofessional service-learning on the effectiveness of knowledge transfer of antimicrobial resistance to Hong Kong elders: a quasi-experiment.,"BACKGROUND


Community perception on antimicrobials plays a role in driving the development of antimicrobial resistance (AMR). The aim of the study was to evaluate the impact of interprofessional service-learning on the effectiveness of AMR knowledge transfer in Hong Kong elders aged 65 or above and students from university and secondary schools.
METHODS


A quasi-experimental pretest-posttest controlled study was carried out from July 2018 to March 2019 for elderly subjects and a pre- and post-test were conducted in students from May to August 2018. Elderly subjects were recruited from the university-based community outreach program. The community outreach team consisted of both university and secondary school students. Students were provided with training of geriatric care and AMR before they reached out to the community. The one-to-one intervention with the aid of video and verbal explanation to educate the elderly about the definition, causes, and consequences of AMR, and preventive measures against AMR was provided. Questionnaires on knowledge of antibiotics and AMR were used as tools to reflect on the effectiveness for both students and elderly subjects. The questionnaire was completed twice, before and 1 week after the intervention. Chi-square test, t tests and regression analysis were used to analyze the data.
RESULTS


A total of 93 Chinese elders, 61 of them in the intervention group and 32 in the control group participated in the study. The score obtained by the intervention group increased from 40.1 to 83.3% (p < 0.001) following intervention, while that of control group increased from 33.0 to 44.0% (p < 0.001). The increase attained in the intervention group was significantly greater than that of the control group (p < 0.001). A total of 95 secondary students and 88 university students have completed the pre-post questionnaires with 42.21% and 13% increment in AMR knowledge after the training (p < 0.001).
CONCLUSION


The significant change in knowledge level showed effective AMR knowledge transfer to both elders and students. The study could be used as a reference when allocating resources to implement effective interprofessional service-learning for better community health education in elderly populations.
TRIAL REGISTRATION


This study was approved by the Chinese University of Hong Kong Survey and Behavioural Research Ethics Committee in December 2018 (Ref no. SBRE-18-214).",2021,The increase attained in the intervention group was significantly greater than that of the control group (p < 0.001).,"['A quasi-experimental pretest-posttest controlled study was carried out from July 2018 to March 2019 for elderly subjects and a pre- and post-test were conducted in students from May to August 2018', '95 secondary students and 88 university students', 'Elderly subjects were recruited from the university-based community outreach program', '93 Chinese elders, 61 of them in the intervention group and 32 in the control group participated in the study', 'students and elderly subjects', 'Hong Kong elders', 'Hong Kong elders aged 65 or above and students from university and secondary schools', 'Chinese University of Hong Kong Survey and Behavioural Research Ethics Committee in December 2018', 'elderly populations']",['interprofessional service-learning'],['AMR knowledge'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282110', 'cui_str': 'Community Outreach'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",93.0,0.00823869,The increase attained in the intervention group was significantly greater than that of the control group (p < 0.001).,"[{'ForeName': 'Anna C Y', 'Initials': 'ACY', 'LastName': 'Lo', 'Affiliation': 'School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong.'}, {'ForeName': 'Joyce T S', 'Initials': 'JTS', 'LastName': 'Li', 'Affiliation': 'Centre for Learning Enhancement And Research, The Chinese University of Hong Kong (CLEAR), Room 502 Hui Yeung Shing Building, Shatin, N.T., Hong Kong.'}, {'ForeName': 'Janita P C', 'Initials': 'JPC', 'LastName': 'Chau', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong.'}, {'ForeName': 'Samuel Y S', 'Initials': 'SYS', 'LastName': 'Wong', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong.'}, {'ForeName': 'David S C', 'Initials': 'DSC', 'LastName': 'Hui', 'Affiliation': 'Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong.'}, {'ForeName': 'Vivian W Y', 'Initials': 'VWY', 'LastName': 'Lee', 'Affiliation': 'Centre for Learning Enhancement And Research, The Chinese University of Hong Kong (CLEAR), Room 502 Hui Yeung Shing Building, Shatin, N.T., Hong Kong. vivianlee@cuhk.edu.hk.'}]",Antimicrobial resistance and infection control,['10.1186/s13756-021-01011-9']
1082,34637414,Targeted Temperature Management in Out-of-Hospital Cardiac Arrest With Shockable Rhythm: A Post Hoc Analysis of the Coronary Angiography After Cardiac Arrest Trial.,"OBJECTIVES


The optimal targeted temperature in patients with shockable rhythm is unclear, and current guidelines recommend targeted temperature management with a correspondingly wide range between 32°C and 36°C. Our aim was to study survival and neurologic outcome associated with targeted temperature management strategy in postarrest patients with initial shockable rhythm.
DESIGN


Observational substudy of the Coronary Angiography after Cardiac Arrest without ST-segment Elevation trial.
SETTING


Nineteen hospitals in The Netherlands.
PATIENTS


The Coronary Angiography after Cardiac Arrest trial randomized successfully resuscitated patients with shockable rhythm and absence of ST-segment elevation to a strategy of immediate or delayed coronary angiography. In this substudy, 459 patients treated with mild therapeutic hypothermia (32.0-34.0°C) or targeted normothermia (36.0-37.0°C) were included. Allocation to targeted temperature management strategy was at the discretion of the physician.
INTERVENTIONS


None.
MEASUREMENTS AND MAIN RESULTS


After 90 days, 171 patients (63.6%) in the mild therapeutic hypothermia group and 129 (67.9%) in the targeted normothermia group were alive (hazard ratio, 0.86 [95% CI, 0.62-1.18]; log-rank p = 0.35; adjusted odds ratio, 0.89; 95% CI, 0.45-1.72). Patients in the mild therapeutic hypothermia group had longer ICU stay (4 d [3-7 d] vs 3 d [2-5 d]; ratio of geometric means, 1.32; 95% CI, 1.15-1.51), lower blood pressures, higher lactate levels, and increased need for inotropic support. Cerebral Performance Category scores at ICU discharge and 90-day follow-up and patient-reported Mental and Physical Health Scores at 1 year were similar in the two groups.
CONCLUSIONS


In the context of out-of-hospital cardiac arrest with shockable rhythm and no ST-elevation, treatment with mild therapeutic hypothermia was not associated with improved 90-day survival compared with targeted normothermia. Neurologic outcomes at 90 days as well as patient-reported Mental and Physical Health Scores at 1 year did not differ between the groups.",2022,Patients in the mild therapeutic hypothermia group had longer ICU stay (4 d,"['459 patients treated with mild therapeutic hypothermia (32.0-34.0°C) or targeted normothermia (36.0-37.0°C) were included', 'Nineteen hospitals in The Netherlands', 'patients with shockable rhythm', 'Out-of-Hospital Cardiac Arrest', 'postarrest patients with initial shockable rhythm', 'resuscitated patients with shockable rhythm and absence of ST-segment elevation to a strategy of immediate or delayed coronary angiography']","['Shockable Rhythm', 'Coronary Angiography']","['Cerebral Performance Category scores at ICU discharge and 90-day follow-up and patient-reported Mental and Physical Health Scores', 'longer ICU stay', 'Neurologic outcomes', '90-day survival', 'lower blood pressures, higher lactate levels', 'Mental and Physical Health Scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}]",459.0,0.0832387,Patients in the mild therapeutic hypothermia group had longer ICU stay (4 d,"[{'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Spoormans', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Jorrit S', 'Initials': 'JS', 'LastName': 'Lemkes', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Gladys N', 'Initials': 'GN', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Nina W', 'Initials': 'NW', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Lucia S D', 'Initials': 'LSD', 'LastName': 'Jewbali', 'Affiliation': 'Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Dubois', 'Affiliation': 'Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Meuwissen', 'Affiliation': 'Department of Cardiology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Tom A', 'Initials': 'TA', 'LastName': 'Rijpstra', 'Affiliation': 'Department of Intensive Care Medicine, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Bosker', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Michiel J', 'Initials': 'MJ', 'LastName': 'Blans', 'Affiliation': 'Department of Intensive Care Medicine, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Gabe B', 'Initials': 'GB', 'LastName': 'Bleeker', 'Affiliation': 'Department of Cardiology, HAGA Hospital, Den Haag, The Netherlands.'}, {'ForeName': 'Remon', 'Initials': 'R', 'LastName': 'Baak', 'Affiliation': 'Department of Intensive Care Medicine, HAGA Hospital, Den Haag, The Netherlands.'}, {'ForeName': 'Georgios J', 'Initials': 'GJ', 'LastName': 'Vlachojannis', 'Affiliation': 'Department of Cardiology, Maasstad Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Bob J W', 'Initials': 'BJW', 'LastName': 'Eikemans', 'Affiliation': 'Department of Intensive Care Medicine, Maasstad Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Armand R J', 'Initials': 'ARJ', 'LastName': 'Girbes', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Center, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'van der Harst', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Iwan C C', 'Initials': 'ICC', 'LastName': 'van der Horst', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Voskuil', 'Affiliation': 'Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Joris J', 'Initials': 'JJ', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Albertus', 'Initials': 'A', 'LastName': 'Beishuizen', 'Affiliation': 'Department of Intensive Care Medicine, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Stoel', 'Affiliation': 'Department of Cardiology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Camaro', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'José P', 'Initials': 'JP', 'LastName': 'Henriques', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Alexander P J', 'Initials': 'APJ', 'LastName': 'Vlaar', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Maarten A', 'Initials': 'MA', 'LastName': 'Vink', 'Affiliation': 'Department of Cardiology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'van den Bogaard', 'Affiliation': 'Department of Intensive Care Medicine, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Ton A C M', 'Initials': 'TACM', 'LastName': 'Heestermans', 'Affiliation': 'Department of Cardiology, Noord West Ziekenhuisgroep, Alkmaar, The Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'de Ruijter', 'Affiliation': 'Department of Intensive Care Medicine, Noord West Ziekenhuisgroep, Alkmaar, The Netherlands.'}, {'ForeName': 'Thijs S R', 'Initials': 'TSR', 'LastName': 'Delnoij', 'Affiliation': 'Department of Intensive Care Medicine, Maastricht University Medical Center, University Maastricht, Maastricht, The Netherlands.'}, {'ForeName': 'Harry J G M', 'Initials': 'HJGM', 'LastName': 'Crijns', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Gillian A J', 'Initials': 'GAJ', 'LastName': 'Jessurun', 'Affiliation': 'Department of Cardiology, Scheper Hospital, Emmen, The Netherlands.'}, {'ForeName': 'Pranobe V', 'Initials': 'PV', 'LastName': 'Oemrawsingh', 'Affiliation': 'Department of Cardiology, Haaglanden Medical Center, Den Haag, The Netherlands.'}, {'ForeName': 'Marcel T M', 'Initials': 'MTM', 'LastName': 'Gosselink', 'Affiliation': 'Department of Cardiology, Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'Koos', 'Initials': 'K', 'LastName': 'Plomp', 'Affiliation': 'Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Magro', 'Affiliation': 'Department of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg, The Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Data Science, Amsterdam University Medical Center, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Paul W G', 'Initials': 'PWG', 'LastName': 'Elbers', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Center, location VUmc, Amsterdam, The Netherlands.'}]",Critical care medicine,['10.1097/CCM.0000000000005271']
1083,34645287,Economic Evaluation of Endovascular Treatment for Acute Ischemic Stroke.,"BACKGROUND AND PURPOSE


Endovascular treatment for acute ischemic stroke has been proven clinically effective, but evidence of the cost-effectiveness based on real-world data is scarce. The aim of this study was to assess whether endovascular therapy plus usual care is cost-effective in comparison to usual care alone in acute ischemic stroke patients.
METHODS


An economic evaluation was performed from a societal perspective with a 2-year time horizon. Empirical data on health outcomes and the use of resources following endovascular treatment were gathered parallel to the MR CLEAN trial (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) and its 2-year follow-up study. Incremental cost-effectiveness ratios were calculated as the extra costs per additional patient with functional independence (modified Rankin Scale score 0-2) and the extra cost per quality-adjusted life year gained.
RESULTS


The mean costs per patient in the intervention group were $126 494 versus $143 331 in the control group (mean difference, -$16 839 [95% CI, -$38 113 to $5456]). Compared with patients in the control group, more patients in the intervention group achieved functional independence, 37.2% versus 23.9% (absolute difference, 13.3% [95% CI, 4.0%-22.0%]) and they generated more quality-adjusted life years, 0.99 versus 0.83 (mean difference of 0.16 [95% CI, 0.04-0.29]). Endovascular treatment dominated standard treatment with $18 233 saved per extra patient with a good outcome and $105 869 saved per additional quality-adjusted life year.
CONCLUSIONS


Endovascular treatment added to usual care is clinically effective, and cost saving in comparison to usual care alone in patients with acute ischemic stroke. Registration: URL: https://www.trialregister.nl/trial/695; Unique identifier: NL695. URL: https://www.isrctn.com; Unique identifier: ISRCTN10888758.",2022,"The mean costs per patient in the intervention group were $126 494 versus $143 331 in the control group (mean difference, -$16 839 [95% CI, -$38 113 to $5456]).","['acute ischemic stroke patients', 'acute ischemic stroke', 'Acute Ischemic Stroke', 'Acute Ischemic Stroke in the Netherlands', 'patients with acute ischemic stroke']","['endovascular therapy plus usual care', 'Endovascular Treatment']","['functional independence', 'Incremental cost-effectiveness ratios', 'extra costs per additional patient with functional independence (modified Rankin Scale score 0-2) and the extra cost per quality-adjusted life year gained', 'mean costs per patient']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0488525,"The mean costs per patient in the intervention group were $126 494 versus $143 331 in the control group (mean difference, -$16 839 [95% CI, -$38 113 to $5456]).","[{'ForeName': 'Lucie A', 'Initials': 'LA', 'LastName': 'van den Berg', 'Affiliation': 'Departments of Neurology (L.A.v.d.B., Y.B.R.).'}, {'ForeName': 'Olvert A', 'Initials': 'OA', 'LastName': 'Berkhemer', 'Affiliation': 'Radiology and Nuclear Medicine (C.B.M.M., O.A.B.), Amsterdam University Medical Center, the Netherlands.'}, {'ForeName': 'Puck S S', 'Initials': 'PSS', 'LastName': 'Fransen', 'Affiliation': 'Departments of Neurology (O.A.B., P.S.S.F., D.W.J.D.), Erasmus MC University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Beumer', 'Affiliation': 'Departments of Neurology (D.B., R.J.v.O.), Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, the Netherlands.'}, {'ForeName': 'Hester', 'Initials': 'H', 'LastName': 'Lingsma', 'Affiliation': 'Public Health (H.L.), Erasmus MC University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Charles B M', 'Initials': 'CBM', 'LastName': 'Majoie', 'Affiliation': 'Radiology and Nuclear Medicine (C.B.M.M., O.A.B.), Amsterdam University Medical Center, the Netherlands.'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': 'Departments of Neurology (O.A.B., P.S.S.F., D.W.J.D.), Erasmus MC University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Aad', 'Initials': 'A', 'LastName': 'van der Lugt', 'Affiliation': 'Radiology (O.A.B., A.v.d.L.), Erasmus MC University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'van Oostenbrugge', 'Affiliation': 'Departments of Neurology (D.B., R.J.v.O.), Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, the Netherlands.'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Zwam', 'Affiliation': 'Radiology (O.A.B., W.H.v.Z.), Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, the Netherlands.'}, {'ForeName': 'Yvo B', 'Initials': 'YB', 'LastName': 'Roos', 'Affiliation': 'Departments of Neurology (L.A.v.d.B., Y.B.R.).'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Clinical Epidemiology, Biostatistics, and Bioinformatics (M.G.W.D.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.121.034599']
1084,34647151,Randomized Trial Suggests Potential Benefits of Polymer Over Suture-Based Vascular Closure.,,2021,,[],['Polymer Over Suture-Based Vascular Closure'],[],[],"[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",[],,0.0911289,,"[{'ForeName': 'Sanjit', 'Initials': 'S', 'LastName': 'Tewari', 'Affiliation': 'Division of Diagnostic Imaging - Department of Nuclear Medicine, The University of Texas MD Anderson Cancer Center, TX, Houston, USA. sanjit.tewari@gmail.com.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-021-02979-y']
1085,34647129,Impact of pretransplant left ventricular assist device support duration on outcome after heart transplantation.,"OBJECTIVES


Heart transplantation after left ventricular assist device (LVAD) implantation remains challenging. It is still unclear whether its support duration impacts the outcome after transplantation.
METHODS


All patients undergoing heart transplantation between 2010 and 2021 at a single department after previous left ventricular assistance were retrospectively reviewed and divided into 4 different study groups with regard to the duration of LVAD support to examine the impact on the postoperative morbidity and mortality.
RESULTS


A total of n = 198 patients were included and assigned to the 4 study groups (group 1: <90 days, n = 14; group 2: 90 days to 1 year, n = 31; group 3: 1-2 years, n = 29; group 4: >2 years, n = 24). Although there were no differences between the 4 groups concerning relevant mismatch between the recipients and donors, the incidence of primary graft dysfunction was numerically increased in patients with the shortest support duration, and also those patients with >1 year of support (group 1: 35.7%, group 2: 25.8%, group 3: 41.4%, group 4: 37.5%, P = 0.63). The incidence of acute graft rejection was by trend increased in patients of group 1 (group 1: 28.6%, group 2: 3.3%, group 3: 7.1%, group 4: 12.5%, P = 0.06). Duration of LVAD support did not impact on perioperative adverse events (infections, P = 0.79; acute kidney injury, P = 0.85; neurological events, P = 0.74; thoracic bleeding, P = 0.61), neither on postoperative survival (1-year survival: group 1: 78.6%, group 2: 66.7%, group 3: 80.0%, group 4: 72.7%, P = 0.74).
CONCLUSION


We cannot identify a significant impact of the duration of pretransplant LVAD support on postoperative outcome; therefore, we cannot recommend a certain timeframe for transplantation of LVAD patients.",2022,"The incidence of acute graft rejection was by trend increased in patients of group 1 (group 1: 28.6%, group 2: 3.3%, group 3: 7.1%, group 4: 12.5%, P = 0.06).","['All patients undergoing heart transplantation between 2010 and 2021 at a single department after previous left ventricular assistance', 'A total of n = 198 patients', 'heart transplantation']","['pretransplant left ventricular assist device support duration', 'Heart transplantation after left ventricular assist device (LVAD) implantation']","['postoperative survival', 'incidence of primary graft dysfunction', 'perioperative adverse events', 'incidence of acute graft rejection', 'postoperative morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0948031', 'cui_str': 'Primary Graft Dysfunction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1736177', 'cui_str': 'Acute graft rejection'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",198.0,0.0476908,"The incidence of acute graft rejection was by trend increased in patients of group 1 (group 1: 28.6%, group 2: 3.3%, group 3: 7.1%, group 4: 12.5%, P = 0.06).","[{'ForeName': 'Moritz Benjamin', 'Initials': 'MB', 'LastName': 'Immohr', 'Affiliation': 'Department of Cardiac Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Hug', 'Initials': 'H', 'LastName': 'Aubin', 'Affiliation': 'Department of Cardiac Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Sophiko', 'Initials': 'S', 'LastName': 'Erbel-Khurtsidze', 'Affiliation': 'Department of Cardiac Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Hannan', 'Initials': 'H', 'LastName': 'Dalyanoglu', 'Affiliation': 'Department of Cardiac Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Raphael Romano', 'Initials': 'RR', 'LastName': 'Bruno', 'Affiliation': 'Department of Cardiology, Pulmonology and Angiology, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Westenfeld', 'Affiliation': 'Department of Cardiology, Pulmonology and Angiology, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Tudorache', 'Affiliation': 'Department of Cardiac Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Akhyari', 'Affiliation': 'Department of Cardiac Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Boeken', 'Affiliation': 'Department of Cardiac Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Lichtenberg', 'Affiliation': 'Department of Cardiac Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivab265']
1086,34655400,"A Double-Blind, Placebo-Controlled, Crossover Study of Magnesium Supplementation in Patients with XMEN Disease.","X-linked MAGT1 deficiency with increased susceptibility to Epstein-Barr virus (EBV) infection and N-linked glycosylation defect (XMEN) disease is an inborn error of immunity caused by loss-of-function mutations in the magnesium transporter 1 (MAGT1) gene. The original studies of XMEN patients focused on impaired magnesium regulation, leading to decreased EBV-cytotoxicity and the loss of surface expression of the activating receptor ""natural killer group 2D"" (NKG2D) on CD8 +  T cells and NK cells. In vitro studies showed that supraphysiological supplementation of magnesium rescued these defects. Observational studies in 2 patients suggested oral magnesium supplementation could decrease EBV viremia. Hence, we performed a randomized, double-blind, placebo-controlled, crossover study in 2 parts. In part 1, patients received either oral magnesium L-threonate (MLT) or placebo for 12 weeks followed by 12 weeks of the other treatment. Part 2 began with 3 days of high-dose intravenous (IV) magnesium sulfate (MgSO 4 ) followed by open-label MLT for 24 weeks. One EBV-infected and 3 EBV-naïve patients completed part 1. One EBV-naïve patient was removed from part 2 of the study due to asymptomatic elevation of liver enzymes during IV MgSO 4 . No change in EBV or NKG2D status was observed. In vitro magnesium supplementation experiments in cells from 14 XMEN patients failed to significantly rescue NKG2D expression and the clinical trial was stopped. Although small, this study indicates magnesium supplementation is unlikely to be an effective therapeutic option in XMEN disease.",2022,In vitro magnesium supplementation experiments in cells from 14 XMEN patients failed to significantly rescue NKG2D expression and the clinical trial was stopped.,['Patients with XMEN Disease'],"['Magnesium Supplementation', 'magnesium sulfate (MgSO 4 ) followed by open-label MLT', 'Placebo', 'oral magnesium L-threonate (MLT) or placebo', 'magnesium supplementation', 'oral magnesium supplementation', 'placebo']","['EBV viremia', 'rescue NKG2D expression', 'EBV or NKG2D status', 'EBV-cytotoxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0024653', 'cui_str': 'Malta'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3855809', 'cui_str': 'MAGNESIUM L-THREONATE'}]","[{'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.455916,In vitro magnesium supplementation experiments in cells from 14 XMEN patients failed to significantly rescue NKG2D expression and the clinical trial was stopped.,"[{'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Chauvin', 'Affiliation': 'Molecular Development of the Immune System Section, Laboratory of Immune System Biology, and Clinical Genomics Program, Division of Intramural Research, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Building 10, Room 11N311, 10 Center Drive, MSC 1892, Bethesda, MD, 20892-1892, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Price', 'Affiliation': 'Laboratory of Clinical Immunology and Microbiology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Molecular Development of the Immune System Section, Laboratory of Immune System Biology, and Clinical Genomics Program, Division of Intramural Research, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Building 10, Room 11N311, 10 Center Drive, MSC 1892, Bethesda, MD, 20892-1892, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hunsberger', 'Affiliation': 'Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Brofferio', 'Affiliation': 'Cardiovascular and Pulmonary Branch, National Heart Lung and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Matthews', 'Affiliation': 'Molecular Development of the Immune System Section, Laboratory of Immune System Biology, and Clinical Genomics Program, Division of Intramural Research, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Building 10, Room 11N311, 10 Center Drive, MSC 1892, Bethesda, MD, 20892-1892, USA.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Similuk', 'Affiliation': 'Molecular Development of the Immune System Section, Laboratory of Immune System Biology, and Clinical Genomics Program, Division of Intramural Research, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Building 10, Room 11N311, 10 Center Drive, MSC 1892, Bethesda, MD, 20892-1892, USA.'}, {'ForeName': 'Sergio D', 'Initials': 'SD', 'LastName': 'Rosenzweig', 'Affiliation': 'Department of Laboratory Medicine, National Institutes of Health Clinical Center, Bethesda, MD, USA.'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Su', 'Affiliation': 'Laboratory of Clinical Immunology and Microbiology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Cohen', 'Affiliation': 'Medical Virology Section, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Lenardo', 'Affiliation': 'Molecular Development of the Immune System Section, Laboratory of Immune System Biology, and Clinical Genomics Program, Division of Intramural Research, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Building 10, Room 11N311, 10 Center Drive, MSC 1892, Bethesda, MD, 20892-1892, USA. lenardo@nih.gov.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Ravell', 'Affiliation': 'Molecular Development of the Immune System Section, Laboratory of Immune System Biology, and Clinical Genomics Program, Division of Intramural Research, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Building 10, Room 11N311, 10 Center Drive, MSC 1892, Bethesda, MD, 20892-1892, USA. juan.ravell@hmhn.org.'}]",Journal of clinical immunology,['10.1007/s10875-021-01137-w']
1087,34637892,Immediately loaded single-implant mandibular overdentures compared to conventional complete dentures: A cost-effectiveness analysis.,"BACKGROUND


In recent years, the single-implant mandibular overdenture (SIMO) has been proposed as an alternative to more complex overdenture designs as a simplified implant intervention for edentulous patients.
OBJECTIVE


The aim of this study was to run a cost-effectiveness analysis alongside a randomized clinical trial comparing the SIMO and the conventional complete denture (CCD) treatment. Imediately loaded external hexagon implant and ball attachment were used for the overdenture goup. Direct costs related to therapies were identified and valuated throughout a 1-year period after delivery, in Brazilian currency (R$) and converted into international dollars (I$) using purchase power parity exchange rates. Treatment effectiveness was measured using the OHIP-Edent and satisfaction scores for calculation of incremental cost-effectiveness ratios (ICER).
RESULTS


Outcomes were assessed at the 1-year follow-up for 65 patients (CCD=34; SIMO=31). Overall OHIP-Edent and satisfaction scores improved significantly in the SIMO group, while remained unchanged in the CCD group. The mean overall costs were R$1,179.04 (I$590.99) for the CCD group and R$2,127.91 (I$1,068.20) for the SIMO group - 80.7% incremental cost for SIMO. The ICER calculation for SIMO treatment showed a mean cost of I$48.20 for 1-point reduction in OHIP-Edent scores, and I$12.56 for 1-point increase in satisfaction score.
CONCLUSIONS


Findings support the effectiveness of this simplified and low-cost implant intervention for edentulous patients. SIMO also seems a cost-effective alternative to the CCD and the relatively low incremental cost may potentially increase the utilization of dental implants among older subjects, especially those with limited financial resources.
CLINICAL SIGNIFICANCE


The immediately loaded single-implant mandibular overdenture was superior to the conventional complete denture in terms of patient-reported outcome measures at a low incremental cost.",2021,The immediately loaded single-implant mandibular overdenture was superior to the conventional complete denture in terms of patient-reported outcome measures at a low incremental cost.,"['edentulous patients', 'older subjects']",['conventional complete denture (CCD) treatment'],"['OHIP-Edent and satisfaction scores for calculation of incremental cost-effectiveness ratios (ICER', 'satisfaction score', 'mean overall costs', 'Overall OHIP-Edent and satisfaction scores']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0433636,The immediately loaded single-implant mandibular overdenture was superior to the conventional complete denture in terms of patient-reported outcome measures at a low incremental cost.,"[{'ForeName': 'Túlio Eduardo', 'Initials': 'TE', 'LastName': 'Nogueira', 'Affiliation': 'School of Dentistry, Federal University of Goias, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Jesio Rodrigues', 'Initials': 'JR', 'LastName': 'Silva', 'Affiliation': 'School of Dentistry, Federal University of Goias, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Lays Noleto', 'Initials': 'LN', 'LastName': 'Nascimento', 'Affiliation': 'School of Dentistry, Federal University of Goias, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Joyce Borges', 'Initials': 'JB', 'LastName': 'Cardoso', 'Affiliation': 'School of Dentistry, Federal University of Goias, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Murali', 'Initials': 'M', 'LastName': 'Srinivasan', 'Affiliation': 'Clinic of General, Special Care, and Geriatric Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'McKenna', 'Affiliation': ""Centre for Public Health, Queen's University, School of Medicine Dentistry & Biomedical Sciences, Institute of Clinical Science, Belfast, United Kingdom.""}, {'ForeName': 'Cláudio Rodrigues', 'Initials': 'CR', 'LastName': 'Leles', 'Affiliation': 'School of Dentistry, Federal University of Goias, Goiânia, Goiás, Brazil. Electronic address: claudio_leles@ufg.br.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103846']
1088,34637889,"CAD-CAM complete removable dental prostheses: A double-blind, randomized, crossover clinical trial evaluating milled and 3D-printed dentures.","OBJECTIVE


This double-blind, randomized, crossover, clinical trial aimed to evaluate and compare the differences between milled and 3D-printed complete removable dental prostheses (CRDPs).
METHODS


Fifteen edentulous patients (men: n = 10, women: n = 5; age: 66.7 ± 8.0 years) rehabilitated with conventional CRDPs were recruited for this trial. Participants were randomized to first receiving either the milled or 3D-printed CAD-CAM manufactured CRDPs and then after 6-weeks cross over to the other set. Both, clinicians and participants were blinded to the group allocation. Outcomes included patient's denture satisfaction (PDS), oral-health related quality of life (OHIP-EDENT), willingness-to-pay analysis, final choice (FC) of CRDPs, clinician's denture quality evaluation (CDQE), chewing efficiency (CE), maximum-voluntary-bite-force (MBF), and prosthodontic maintenance needs. The outcomes were measured at baseline (with old CRDPs), at 1 and 6 weeks after new CRDP insertion; following crossover with the second set of CRDPs, an identical protocol was followed. Generalized linear regression for repeated measures was used for statistical analysis with α=0.05.
RESULTS


All participants completed the trial. 3D-printed CRDPs required more maintenance visits, adjustment time (p = 0.0003), and adjustment costs (p = 0.021). Patients were willing-to-pay an average of 606.67 Swiss Francs more than the actual cost for the milled CRDPs. There were no differences in the PDS, OHIP, FC, CDQE, CE, and MBF between the two CRDPs groups.
CONCLUSIONS


The findings of this double-blind randomized crossover clinical trial confirm that both milled and 3D-printed CRDPs are valid treatment modalities for edentulous patients, with the latter performing inferiorly with regard to the time and costs involved with the prosthodontic aftercare, as well as the patients' willingness-to-pay.
CLINICAL RELEVANCE


The findings of this trial provide evidence to help the clinician in choosing the appropriate CAD-CAM manufacturing process for fabricating the CRDPs.",2021,"3D-printed CRDPs required more maintenance visits, adjustment time (p=0.0003), and adjustment costs (p=0.021).","[""edentulous patients, with the latter performing inferior with regards to prosthodontic aftercare, cost and patients' willingness-to-pay"", 'CAD-CAM complete removable dental prostheses', 'Fifteen edentulous patients (men: n=10, women: n=5; age: 66.7±8.0 years) rehabilitated with conventional CRDPs were recruited for this trial']","['milled and 3D-printed CRDPs', 'milled and 3D-printed complete removable dental prostheses (CRDPs']","[""patient's denture satisfaction (PDS), and oral-health related quality of life (OHIP-EDENT), willingness-to-pay analysis, final choice (FC) of CRDPs, clinician's denture quality evaluation (CDQE), chewing efficiency (CE), maximum-voluntary-bite-force (MBF), and prosthodontic maintenance needs"", 'PDS, OHIP, FC, CDQE, CE, and MBF']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0033590', 'cui_str': 'Prosthodontics'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0162514', 'cui_str': 'CAD-CAM'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0599997', 'cui_str': 'Mill'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0033590', 'cui_str': 'Prosthodontics'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]",15.0,0.527979,"3D-printed CRDPs required more maintenance visits, adjustment time (p=0.0003), and adjustment costs (p=0.021).","[{'ForeName': 'Murali', 'Initials': 'M', 'LastName': 'Srinivasan', 'Affiliation': 'Clinic of General, Special care, and Geriatric dentistry, Centre of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032 Zurich, Switzerland; Division of Gerodontology and Removable Prosthodontics, University Clinics of Dental Medicine, University of Geneva, Rue Michel-Servet 1, 1211 Geneva - 4, Switzerland. Electronic address: murali.srinivasan@zzm.uzh.ch.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Kalberer', 'Affiliation': 'Clinic of General, Special care, and Geriatric dentistry, Centre of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032 Zurich, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Fankhauser', 'Affiliation': 'Clinic of General, Special care, and Geriatric dentistry, Centre of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032 Zurich, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Naharro', 'Affiliation': 'Division of Gerodontology and Removable Prosthodontics, University Clinics of Dental Medicine, University of Geneva, Rue Michel-Servet 1, 1211 Geneva - 4, Switzerland.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Maniewicz', 'Affiliation': 'Division of Gerodontology and Removable Prosthodontics, University Clinics of Dental Medicine, University of Geneva, Rue Michel-Servet 1, 1211 Geneva - 4, Switzerland.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Division of Gerodontology and Removable Prosthodontics, University Clinics of Dental Medicine, University of Geneva, Rue Michel-Servet 1, 1211 Geneva - 4, Switzerland; Department of Rehabilitation and Geriatrics, University Hospitals of Geneva, Chemin du Pont-Bochet 3, 1226 Thônex, Switzerland.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103842']
1089,34654942,Effect of bleaching gel volume on color change and postoperative sensitivity: a randomized clinical study.,"OBJECTIVES


Although bleaching therapy is considered a dose-dependent treatment, the effect of the volume of product used is yet to be studied. This study thus aimed to evaluate the influence of bleaching gel volume on chromatic alteration and postoperative sensitivity.
METHODOLOGY


Thirty patients were selected and allocated into three groups; the lower canines were analyzed according to the volume of gel used: GI-0.025 mL, GII-0.05 mL, and GIII-0.10 mL. Chromatic alteration analysis was performed using a portable digital spectrophotometer by calculating the ΔE, ΔE00, ΔL*, Δa*, and Δb* values and the whiteness index (W ID ). Spontaneous sensitivity was assessed using a questionnaire, and sensitivity was stimulated by thermo-sensory analysis. Analyses were conducted in five stages: baseline, after 1st, 2nd, and 3rd bleaching sessions, and 14 days after the end. Data were analyzed using the two-way ANOVA test with repeated measures and Tukey's post hoc test (p < 0.05).
RESULTS


It was observed that ΔE, ΔE00, and ΔL* were similar between groups at the end of the bleaching therapy; and the values of Δa*, Δb*, and WID were higher in the GIII group. For sensitivity, it was found that the GI was the one with the lowest values; o GII intermediate values; while the GIII group presents the highest values of spontaneous and stimulated sensitivity.
CONCLUSION


Gel volume influenced the response to bleaching and significantly influenced the spontaneous sensitivity and cold stimulus.
CLINICAL RELEVANCE


The amount of bleaching gel used during therapy is key to both the response to color change and postoperative sensitivity.",2022,"It was observed that ΔE, ΔE00, and ΔL* were similar between groups at the end of the bleaching therapy; and the values of Δa*, Δb*, and WID were higher in the GIII group.",['Thirty patients'],"['bleaching therapy', 'bleaching gel', 'bleaching gel volume']","['Spontaneous sensitivity', 'color change and postoperative sensitivity', 'spontaneous sensitivity and cold stimulus']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0475330', 'cui_str': 'Color change'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",30.0,0.0282238,"It was observed that ΔE, ΔE00, and ΔL* were similar between groups at the end of the bleaching therapy; and the values of Δa*, Δb*, and WID were higher in the GIII group.","[{'ForeName': 'Lara Maria Bueno', 'Initials': 'LMB', 'LastName': 'Esteves', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry Araçatuba, São Paulo State University (UNESP), José Bonifácio, 1193, Vila Mendonça, Araçatuba, São Paulo, 16015-050, Brazil.'}, {'ForeName': 'Paulo Henrique', 'Initials': 'PH', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Dental Materials and Prosthodontics, School of Dentistry Araçatuba, São Paulo State University (UNESP), José Bonifácio, 1193, Vila Mendonça, Araçatuba, São Paulo, Brazil.'}, {'ForeName': 'Ticiane Cestari', 'Initials': 'TC', 'LastName': 'Fagundes', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry Araçatuba, São Paulo State University (UNESP), José Bonifácio, 1193, Vila Mendonça, Araçatuba, São Paulo, 16015-050, Brazil.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'de Oliveira Gallinari', 'Affiliation': 'Department of Operative Dentistry, Endodontics and Dental Materials, Bauru School of Dentistry (USP), Bauru, São Paulo, Brazil.'}, {'ForeName': 'Giulia Bessa', 'Initials': 'GB', 'LastName': 'de Mello Antonaccio', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry Araçatuba, São Paulo State University (UNESP), José Bonifácio, 1193, Vila Mendonça, Araçatuba, São Paulo, 16015-050, Brazil.'}, {'ForeName': 'Luciano Tavares Ângelo', 'Initials': 'LTÂ', 'LastName': 'Cintra', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry Araçatuba, São Paulo State University (UNESP), José Bonifácio, 1193, Vila Mendonça, Araçatuba, São Paulo, 16015-050, Brazil.'}, {'ForeName': 'André Luiz Fraga', 'Initials': 'ALF', 'LastName': 'Briso', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry Araçatuba, São Paulo State University (UNESP), José Bonifácio, 1193, Vila Mendonça, Araçatuba, São Paulo, 16015-050, Brazil. andre.briso@unesp.br.'}]",Clinical oral investigations,['10.1007/s00784-021-04220-z']
1090,34653558,l-Glutamine supplementation enhances glutathione peroxidase and paraoxonase-1 activities in HDL of exercising older individuals.,"BACKGROUND


Oxidative stress is an important factor in the formation of atherosclerotic plaques. High-density lipoprotein (HDL) harbors paraoxonase-1 (PON-1) and glutathione peroxidase (GPx), key enzymes in the protection against the harmful effects of oxidative stress. Although exercise training can increase both HDL-c content and its antioxidant action, and glutamine (Gln) intake also promotes GPx-based defenses, the association between exercise training and Gln in the regulation of PON-1 activity was not explored. Therefore, the objective of this study was to investigate the effects of Gln supplementation on the redox balance and on the total HDL antioxidant capacity by evaluation of the activity of PON-1 and GPx enzymes in physically exercised elderly individuals compared to non-exercised ones.
METHODS


Fifty-one practitioners of a combined exercise training program (CET, age: 71.9 ± 5.7 years) and 32 non-practitioners (NP, age: 73 ± 6.3 years) participated in the study. CET and NP groups were separated into 2 subgroups according to the supplementation: Gln, 0.3 g/kg/day + 10 g maltodextrin (CET-Gln, n = 26; and NP-Gln, n = 16) or placebo, 10 g maltodextrin (CET-PL, n = 25; and NP-PL, n = 16). Blood samples were drawn at baseline and after 30 days after commencement of the supplementation for biochemical and enzyme activity analyses.
RESULTS


Increased HDL-c, total peroxidase (PRx), and GPx activities were found in both CET-Gln and NP-Gln after the supplementation period, compared to baseline, in opposition to CET-PL and NP-PL groups. PON-1 activity increased only in CET-Gln. In both CET-Gln and NP-Gln groups, there was a reduction of the total peroxides/PRx, iron/PRx, and total peroxides/GPX ratios after supplementation. In CET-Gln, thiobarbituric acid-reactive substances (TBARS)/PRx and TBARS/GPx ratios were also lower after supplementation. CET-Gln and CET-PL subgroups had lower glycemia than NP-Gln and NP-PL, either at baseline or after the supplementation periods. The other parameters were unchanged after supplementation [total cholesterol, LDL-c, triglycerides, non-HDL cholesterol, total peroxides, TBARS, iron serum, Trolox-equivalent antioxidant capacity (TEAC), and uric acid].
CONCLUSIONS


Gln supplementation can increase glutathione peroxidase activity regardless the individuals were physically active or sedentary, but the PON-1 activity only increased in physically active individuals. These results show the potential of Gln supplementation in the maintenance of the vascular redox balance, with potential implications for atherogenesis protection.",2021,"In both CET-Gln and NP-Gln groups, there was a reduction of the total peroxides/PRx, iron/PRx, and total peroxides/GPX ratios after supplementation.","['Fifty-one practitioners of a', 'physically exercised elderly individuals compared to non-exercised ones', 'HDL of exercising older individuals', 'CET, age: 71.9\u202f±\u202f5.7\u202fyears) and 32 non-practitioners (NP, age: 73\u202f±\u202f6.3\u202fyears) participated in the study']","['exercise training', 'CET', 'CET-Gln and CET-PL', 'maltodextrin (CET-Gln, n\u202f=\u202f26; and NP-Gln, n\u202f=\u202f16) or placebo, 10\u202fg maltodextrin', 'l-Glutamine supplementation', 'Gln supplementation', 'combined exercise training program']","['High-density lipoprotein (HDL) harbors paraoxonase-1', 'total peroxides/PRx, iron/PRx, and total peroxides/GPX ratios', 'PON-1 activity', 'supplementation [total cholesterol, LDL-c, triglycerides, non-HDL cholesterol, total peroxides, TBARS, iron serum, Trolox-equivalent antioxidant capacity (TEAC), and uric acid', 'HDL-c, total peroxidase (PRx), and GPx activities', 'HDL-c content and its antioxidant action, and glutamine (Gln) intake', 'glutathione peroxidase activity', 'glutathione peroxidase and paraoxonase-1 activities', 'thiobarbituric acid-reactive substances (TBARS)/PRx and TBARS/GPx ratios']","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C1121571', 'cui_str': 'Paraoxonase 1'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031180', 'cui_str': 'Peroxide'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0147003', 'cui_str': 'Trolox C'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0076442', 'cui_str': 'thiobarbituric acid'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}]",,0.141564,"In both CET-Gln and NP-Gln groups, there was a reduction of the total peroxides/PRx, iron/PRx, and total peroxides/GPX ratios after supplementation.","[{'ForeName': 'Renier S', 'Initials': 'RS', 'LastName': 'Pires', 'Affiliation': 'Post-Graduation Program in Health Sciences, Santo Amaro University (UNISA), São Paulo, SP 04829-300, Brazil.'}, {'ForeName': 'Pedro G S', 'Initials': 'PGS', 'LastName': 'Braga', 'Affiliation': 'Lipid Metabolism Laboratory, Heart Institute (InCor), Medical School Hospital, University of São Paulo, SP 05403-900, Brazil.'}, {'ForeName': 'Juliana M B', 'Initials': 'JMB', 'LastName': 'Santos', 'Affiliation': 'Post-Graduation Program in Science of Human and Rehabilitation, Federal University of São Paulo (UNIFESP), Santos, SP 11015-020, Brazil.'}, {'ForeName': 'Jônatas B', 'Initials': 'JB', 'LastName': 'Amaral', 'Affiliation': 'ENT Lab, Department of Otorhinolaryngology, Federal University of São Paulo (UNIFESP), São Paulo, SP 04025-002, Brazil.'}, {'ForeName': 'Gislene R', 'Initials': 'GR', 'LastName': 'Amirato', 'Affiliation': 'ENT Lab, Department of Otorhinolaryngology, Federal University of São Paulo (UNIFESP), São Paulo, SP 04025-002, Brazil.'}, {'ForeName': 'Caio S', 'Initials': 'CS', 'LastName': 'Trettel', 'Affiliation': 'Interdisciplinary Program in Health Sciences, Institute of Physical Activity Sciences and Sports (ICAFE), Cruzeiro do Sul University, São Paulo, SP 01506-000, Brazil.'}, {'ForeName': 'Carlos A F', 'Initials': 'CAF', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Medicine (Geriatrics and Gerontology), Federal University of São Paulo (UNIFESP), São Paulo, SP 04020-050, Brazil.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Vaisberg', 'Affiliation': 'ENT Lab, Department of Otorhinolaryngology, Federal University of São Paulo (UNIFESP), São Paulo, SP 04025-002, Brazil.'}, {'ForeName': 'Luis H S', 'Initials': 'LHS', 'LastName': 'Nali', 'Affiliation': 'Post-Graduation Program in Health Sciences, Santo Amaro University (UNISA), São Paulo, SP 04829-300, Brazil.'}, {'ForeName': 'Rodolfo P', 'Initials': 'RP', 'LastName': 'Vieira', 'Affiliation': 'Post-Graduation Program in Science of Human and Rehabilitation, Federal University of São Paulo (UNIFESP), Santos, SP 11015-020, Brazil; Post-graduation Program in Bioengineering and Biomedical Engineering, Universidade Brasil, São Paulo, SP 08230-030, Brazil; Brazilian Institute of Teaching and Research in Pulmonary and Exercise Immunology (IBEPIPE), São Jose dos Campos, SP 12245-520, Brazil.'}, {'ForeName': 'Raul C', 'Initials': 'RC', 'LastName': 'Maranhão', 'Affiliation': 'Lipid Metabolism Laboratory, Heart Institute (InCor), Medical School Hospital, University of São Paulo, SP 05403-900, Brazil.'}, {'ForeName': 'Tania C', 'Initials': 'TC', 'LastName': 'Pithon-Curi', 'Affiliation': 'Interdisciplinary Program in Health Sciences, Institute of Physical Activity Sciences and Sports (ICAFE), Cruzeiro do Sul University, São Paulo, SP 01506-000, Brazil.'}, {'ForeName': 'Marcelo P', 'Initials': 'MP', 'LastName': 'Barros', 'Affiliation': 'Interdisciplinary Program in Health Sciences, Institute of Physical Activity Sciences and Sports (ICAFE), Cruzeiro do Sul University, São Paulo, SP 01506-000, Brazil.'}, {'ForeName': 'André L L', 'Initials': 'ALL', 'LastName': 'Bachi', 'Affiliation': 'Post-Graduation Program in Health Sciences, Santo Amaro University (UNISA), São Paulo, SP 04829-300, Brazil; ENT Lab, Department of Otorhinolaryngology, Federal University of São Paulo (UNIFESP), São Paulo, SP 04025-002, Brazil; Brazilian Institute of Teaching and Research in Pulmonary and Exercise Immunology (IBEPIPE), São Jose dos Campos, SP 12245-520, Brazil. Electronic address: allbachi77@gmail.com.'}]",Experimental gerontology,['10.1016/j.exger.2021.111584']
1091,34653557,Short-term community-based exercise programs in low-income older women: Does exercise intensity and modality matters?,"Our aim was to evaluate the effect of community-based exercise program (CBEP) intensity and modality on anthropometric, hemodynamic, and functional capacity parameters in low-income older women. Forty insufficiently active older women (68.2 ± 7.9 years) were randomly assigned to perform 12 weeks of twice-weekly high-intensity interval training combined with resistance training (HIIT+RT/n = 12), moderate-intensity continuous training combined with resistance training (MICT+RT/n = 13), or resistance training alone (RT/n = 15). Anthropometric (body mass index and waist circumference), hemodynamic (blood pressure and heart rate), and functional capacity variables (flexibility, upper and lower limb muscle strength, and mobility) were assessed before and after training programs. Waist circumference reduced similarly after all CBEP (~3 to ~4 cm; P < 0.05). Tendency toward reduction in diastolic blood pressure (~4 mm Hg; P = 0.073), and improvements in flexibility (14.5%, P = 0.011) and handgrip strength (15.8%; P = 0.02) were found only in HIIT+RT. Indeed, only RT was effective to improve five-time sit to stand (14.1%; P = 0.013). No significant difference between groups was found during follow-up in any variable. The results of present study suggest that low-income older women may improve anthropometric, hemodynamic and functional capacity variables by participating in twice-weekly short-term (i.e.: 12 weeks) CBEP. However, the CBEP-effects on hemodynamic and functional capacity appears to be affected by exercise intensity (only HIIT+RT tended toward improving diastolic BP) and modality (only RT improved significantly five-time sit to stand), respectively.",2021,"Indeed, only RT was effective to improve five-time sit to stand (14.1%; P = 0.013).","['Forty insufficiently active older women (68.2\u202f±\u202f7.9\u202fyears', 'low-income older women']","['Short-term community-based exercise programs', 'community-based exercise program (CBEP) intensity and modality', 'twice-weekly high-intensity interval training combined with resistance training (HIIT+RT/n\u202f=\u202f12), moderate-intensity continuous training combined with resistance training (MICT+RT/n\u202f=\u202f13), or resistance training alone']","['diastolic BP', 'hemodynamic and functional capacity', 'flexibility', 'diastolic blood pressure', 'Waist circumference', 'anthropometric, hemodynamic and functional capacity variables', 'handgrip strength', 'Anthropometric (body mass index and waist circumference), hemodynamic (blood pressure and heart rate), and functional capacity variables (flexibility, upper and lower limb muscle strength, and mobility']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",40.0,0.00734094,"Indeed, only RT was effective to improve five-time sit to stand (14.1%; P = 0.013).","[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Teixeira do Amaral', 'Affiliation': 'São Paulo State University - UNESP, School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory - ECDR, Bauru, SP, Brazil.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Fernandes', 'Affiliation': 'São Paulo State University - UNESP, School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory - ECDR, Bauru, SP, Brazil.'}, {'ForeName': 'Awassi Yuphiwa', 'Initials': 'AY', 'LastName': 'Ngomane', 'Affiliation': 'São Paulo State University - UNESP, School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory - ECDR, Bauru, SP, Brazil.'}, {'ForeName': 'Isabela Roque', 'Initials': 'IR', 'LastName': 'Marçal', 'Affiliation': 'São Paulo State University - UNESP, School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory - ECDR, Bauru, SP, Brazil.'}, {'ForeName': 'Gabriel de Souza', 'Initials': 'GS', 'LastName': 'Zanini', 'Affiliation': 'São Paulo State University - UNESP, School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory - ECDR, Bauru, SP, Brazil.'}, {'ForeName': 'Emmanuel Gomes', 'Initials': 'EG', 'LastName': 'Ciolac', 'Affiliation': 'São Paulo State University - UNESP, School of Sciences, Department of Physical Education, Exercise and Chronic Disease Research Laboratory - ECDR, Bauru, SP, Brazil. Electronic address: emmanuel.ciolac@unesp.br.'}]",Experimental gerontology,['10.1016/j.exger.2021.111591']
1092,34670201,Brain network effects by continuous theta burst stimulation in mal de débarquement syndrome: simultaneous EEG and fMRI study.,"Objective . Heterogeneous clinical responses to treatment with non-invasive brain stimulation are commonly observed, making it necessary to determine personally optimized stimulation parameters. We investigated neuroimaging markers of effective brain targets of treatment with continuous theta burst stimulation (cTBS) in mal de débarquement syndrome (MdDS), a balance disorder of persistent oscillating vertigo previously shown to exhibit abnormal intrinsic functional connectivity. Approach. Twenty-four right-handed, cTBS-naive individuals with MdDS received single administrations of cTBS over one of three stimulation targets in randomized order. The optimal target was determined based on the assessment of acute changes after the administration of cTBS over each target. Repetitive cTBS sessions were delivered on three consecutive days with the optimal target chosen by the participant. Electroencephalography (EEG) was recorded at single-administration test sessions of cTBS. Simultaneous EEG and functional MRI data were acquired at baseline and after completion of 10-12 sessions. Network connectivity changes after single and repetitive stimulations of cTBS were analyzed. Main results. Using electrophysiological source imaging and a data-driven method, we identified network-level connectivity changes in EEG that correlated with symptom responses after completion of multiple sessions of cTBS. We further determined that connectivity changes demonstrated by EEG during test sessions of single administrations of cTBS were signatures that could predict optimal targets. Significance. Our findings demonstrate the effect of cTBS on resting state brain networks and suggest an imaging-based, closed-loop stimulation paradigm that can identify optimal targets during short-term test sessions of stimulation. ClinicalTrials.gov Identifier: NCT02470377.",2021,"Using electrophysiological source imaging and a data-driven method, we identified network-level connectivity changes in EEG that correlated with symptom responses after completion of multiple sessions of cTBS.","['Twenty-four right-handed, cTBS-naive individuals with MdDS received single administrations of', 'Mal de Débarquement Syndrome', 'Mal de Débarquement Syndrome (MdDS']","['continuous theta burst stimulation', 'cTBS', 'continuous theta burst stimulation (cTBS']","['Simultaneous EEG and fMRI data', 'EEG']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024551', 'cui_str': 'Malayalam language'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",24.0,0.0438787,"Using electrophysiological source imaging and a data-driven method, we identified network-level connectivity changes in EEG that correlated with symptom responses after completion of multiple sessions of cTBS.","[{'ForeName': 'Yafen', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Stephenson School of Biomedical Engineering, University of Oklahoma, Norman, OK, United States of America.'}, {'ForeName': 'Yoon-Hee', 'Initials': 'YH', 'LastName': 'Cha', 'Affiliation': 'University of Minnesota, Minneapolis, MN, United States of America.'}, {'ForeName': 'Diamond', 'Initials': 'D', 'LastName': 'Gleghorn', 'Affiliation': 'Missouri State University, Springfield, MO, United States of America.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Doudican', 'Affiliation': 'Oklahoma State University, Tulsa, OK, United States of America.'}, {'ForeName': 'Guofa', 'Initials': 'G', 'LastName': 'Shou', 'Affiliation': 'Stephenson School of Biomedical Engineering, University of Oklahoma, Norman, OK, United States of America.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Stephenson School of Biomedical Engineering, University of Oklahoma, Norman, OK, United States of America.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Stephenson School of Biomedical Engineering, University of Oklahoma, Norman, OK, United States of America.'}]",Journal of neural engineering,['10.1088/1741-2552/ac314b']
1093,34648425,A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance.,"STUDY OBJECTIVES


This study examines the impact of cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) therapy for comorbid insomnia and sleep apnea on nocturnal sleep and daytime functioning.
METHODS


A partial factorial design was used to examine treatment pathways with CBT-I and PAP and the relative benefits of each treatment. One hundred eighteen individuals with comorbid insomnia and sleep apnea were randomized to receive CBT-I followed by PAP, self-monitoring followed by CBT-I concurrent with PAP, or self-monitoring followed by PAP only. Participants were assessed at baseline, PAP titration, and 30 and 90 days after PAP initiation. Outcome measures included sleep diary- and actigraphy-measured sleep, Flinders Fatigue Scale, Epworth Sleepiness Scale, Functional Outcome of Sleep Questionnaire, and cognitive emotional measures.
RESULTS


A main effect of time was found on diary-measured sleep parameters (decreased sleep onset latency and wake after sleep onset; increased total sleep time and sleep efficiency) and actigraphy-measured sleep parameters (decreased wake after sleep onset; increased sleep efficiency) and daytime functioning (reduced Epworth Sleepiness Scale, Flinders Fatigue Scale; increased Functional Outcome of Sleep Questionnaire) across all arms (all  P  < .05). Significant interactions and planned contrast comparisons revealed that CBT-I was superior to PAP and self-monitoring on reducing diary-measured sleep onset latency and wake after sleep onset and increasing sleep efficiency, as well as improving Functional Outcome of Sleep Questionnaire and Flinders Fatigue Scale compared to self-monitoring.
CONCLUSIONS


Improvements in sleep and daytime functioning were found with PAP alone or concomitant with CBT-I. However, more rapid effects were observed on self-reported sleep and daytime performance when receiving CBT-I regardless of when it was initiated. Therefore, concomitant treatment appears to be a favorable approach to accelerate treatment outcomes.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea (MATRICS); URL: https://clinicaltrials.gov/ct2/show/NCT01785303; Identifier: NCT01785303.
CITATION


Tu AY, Crawford MR, Dawson SC, et al. A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance.  J Clin Sleep Med . 2022;18(3):789-800.",2022,"Significant interactions and planned contrast comparisons revealed that CBT-I was superior to PAP and self-monitoring on reducing diary-measured SOL and WASO and increasing SE; as well as improving FOSQ and FFS compared to self-monitoring.
","['obstructive sleep apnea and comorbid insomnia', '118 individuals with COMISA']","['positive airway pressure (PAP) therapy', 'cognitive-behavioral therapy', 'CBT-I followed by PAP, self-monitoring followed by CBT-I concurrent with PAP, or self-monitoring followed by PAP only', 'CBT-I and PAP']","['diary-measured SOL and WASO and increasing SE', 'sleep diary- and actigraphy-measured sleep, Flinders Fatigue Scale(FFS), Epworth Sleepiness Scale(ESS), Functional Outcome of Sleep Questionnaire(FOSQ), and cognitive-emotional measures', 'FOSQ and FFS', 'sleep onset latency[SOL', 'total sleep time[TST] and sleep efficiency[SE]) and actigraphy-measured sleep parameter', 'nocturnal sleep and daytime performance', 'subjective sleep and daytime performance', 'comorbid insomnia and sleep apnea (COMISA', 'sleep and daytime functioning', 'SE) and daytime functioning (reduced ESS, FFS; increased FOSQ']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0206630', 'cui_str': 'Endometrial stromal sarcoma'}]",118.0,0.0571047,"Significant interactions and planned contrast comparisons revealed that CBT-I was superior to PAP and self-monitoring on reducing diary-measured SOL and WASO and increasing SE; as well as improving FOSQ and FFS compared to self-monitoring.
","[{'ForeName': 'Alice Y', 'Initials': 'AY', 'LastName': 'Tu', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Crawford', 'Affiliation': 'School of Psychological Sciences and Health, University of Strathclyde, Glasgow, United Kingdom.'}, {'ForeName': 'Spencer C', 'Initials': 'SC', 'LastName': 'Dawson', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, Indiana.'}, {'ForeName': 'Louis F', 'Initials': 'LF', 'LastName': 'Fogg', 'Affiliation': 'College of Nursing, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Arlener D', 'Initials': 'AD', 'LastName': 'Turner', 'Affiliation': 'Center for Translational Sleep and Circadian Sciences, Department of Psychiatry and Behavioral Sciences, University of Miami, Miami, Florida.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Wyatt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Crisostomo', 'Affiliation': ''}, {'ForeName': 'Bantu S', 'Initials': 'BS', 'LastName': 'Chhangani', 'Affiliation': 'Department of Medicine, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Clete A', 'Initials': 'CA', 'LastName': 'Kushida', 'Affiliation': 'Division of Sleep Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Jack D', 'Initials': 'JD', 'LastName': 'Edinger', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, National Jewish Health, Denver, Colorado.'}, {'ForeName': 'Sabra M', 'Initials': 'SM', 'LastName': 'Abbott', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Roneil G', 'Initials': 'RG', 'LastName': 'Malkani', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Hrayr P', 'Initials': 'HP', 'LastName': 'Attarian', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Ong', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9696']
1094,34648187,Pharmacokinetic Simulation Analysis of Less Frequent Nivolumab and Pembrolizumab Dosing: Pharmacoeconomic Rationale for Dose Deescalation.,"Nivolumab and pembrolizumab, anti-programmed cell death protein 1 monoclonal antibodies, have revolutionized oncology but are expensive. Using an interventional pharmacoeconomic approach, these drugs can be administered less often to reduce costs and increase patient convenience while maintaining efficacy. Both drugs are good candidates for less frequent dosing because of long half-lives and no evidence of a relationship of dose to efficacy. Established population pharmacokinetic models for both nivolumab and pembrolizumab were used to simulate profiles for multiple dosing regimens on 1000 randomly generated virtual patients. Simulations were initially performed on standard dose regimens to validate these in silico predictions. Next, simulations of nivolumab 0.3 mg/kg every 3 weeks revealed that >95% of patients maintained ≥1.5 μg/mL at steady state, which was inferred as the minimum effective concentration (MEC) for both drugs. Various alternative dosing regimens were simulated for both drugs to determine which regimen(s) can maintain this MEC in >95% of patients. Extended dosing regimens of nivolumab 240 mg every 4 weeks and 480 mg every 8 weeks along with pembrolizumab 200 mg every 6 weeks were simulated, showing that >95% of patients maintained MEC or greater. These simulations demonstrate the potential to reduce drug exposure by at least 50%, thus substantially reducing patient visits (as well as costs), while maintaining equivalent efficacy. These models provide the scientific justification for an ongoing prospective randomized clinical trial comparing standard interval fixed dosing with extended interval fixed dosing, and ultimately an efficacy-driven comparative trial.",2022,Both drugs are good candidates for less frequent dosing because of long half-lives and no evidence of a relationship of dose to efficacy.,['1000 randomly generated virtual patients'],"['pembrolizumab', 'nivolumab 240 mg q4w and 480 mg']",['patient visits'],"[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}]",1000.0,0.0453573,Both drugs are good candidates for less frequent dosing because of long half-lives and no evidence of a relationship of dose to efficacy.,"[{'ForeName': 'Cody J', 'Initials': 'CJ', 'LastName': 'Peer', 'Affiliation': 'Clinical Pharmacology Program, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Heiss', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, and Committee on Clinical Pharmacology & Pharmacogenomics, The University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Goldstein', 'Affiliation': 'Davidoff Cancer Center, Rabin Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Goodell', 'Affiliation': 'Clinical Pharmacology Program, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Figg', 'Affiliation': 'Clinical Pharmacology Program, National Cancer Institute, Bethesda, Maryland, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Ratain', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, and Committee on Clinical Pharmacology & Pharmacogenomics, The University of Chicago, Chicago, Illinois, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1984']
1095,34675055,A Randomized Trial Comparing Weekly With Every Second Week Sharp Debridement in People With Diabetes-Related Foot Ulcers Shows Similar Healing Outcomes: Potential Benefit to Resource Utilization.,,2021,,['People With Diabetes-Related Foot'],['Weekly With Every Second Week Sharp Debridement'],['Healing Outcomes'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0585312', 'cui_str': 'Every second'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0205422,,"[{'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Nube', 'Affiliation': 'Royal Prince Alfred Hospital Department of Podiatry, Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'White', 'Affiliation': 'Royal Prince Alfred Hospital Department of Podiatry, Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Brewer', 'Affiliation': 'Clinical Trials Centre, National Health and Medical Research Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Veldhoen', 'Affiliation': 'Royal Prince Alfred Hospital Department of Podiatry, Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Meler', 'Affiliation': 'Bankstown Hospital, Sydney, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Frank', 'Affiliation': 'Royal Prince Alfred Hospital Department of Podiatry, Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Carroll', 'Affiliation': 'John Hunter Hospital, Newcastle, Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Featherston', 'Affiliation': ""St Vincent's Hospital, Sydney, Australia.""}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Batchelor', 'Affiliation': 'Hornsby Hospital, Sydney, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'Clinical Trials Centre, National Health and Medical Research Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Alison', 'Affiliation': 'Sydney Local Health District Professorial Unit, Sydney, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Twigg', 'Affiliation': 'Faculty of Medicine and Health, Sydney Medical School (Central), The University of Sydney, Sydney, Australia stephen.twigg@sydney.edu.au.'}]",Diabetes care,['10.2337/dc21-1454']
1096,34644389,Efficacy and Utilization of Smartphone Applications for Smoking Cessation Among American Indians and Alaska Natives: Results From the iCanQuit Trial.,"INTRODUCTION


There is tremendous need for efficacious and accessible interventions for smoking cessation among American Indians and Alaska Natives. We tested the efficacy of an Acceptance and Commitment Therapy (ACT)-based smartphone application (iCanQuit) versus US Clinical Practice Guidelines-based smartphone application (QuitGuide) for smoking cessation among American Indians and Alaska Natives.
AIMS AND METHODS


We compared cessation, changes in ACT-based processes, engagement and satisfaction between American Indian and Alaska Native iCanQuit (n = 89) and QuitGuide (n = 80) participants enrolled in the iCanQuit trial. The primary outcome was self-reported, complete-case, 30-day point-prevalence abstinence. Follow-up timepoints were 12, 6, and 3 months.
RESULTS


Randomized American Indians and Alaska Natives from 31 US states (70% urban, 30% rural, with 25% of participants residing on tribal land). The outcome data retention rates were 93%, 92%, and 90% at the 12-, 6-, and 3-month follow-ups, respectively, with no differential retention between arms. The 30-day point-prevalence abstinence for iCanQuit versus QuitGuide was 30% versus 18% at 12 months (odds ratio [OR] = 1.96; 95% confidence interval [CI]: 0.90 to 4.26) 25% versus 11% at 6 months (OR = 2.62; 95% CI: 1.06 to 6.45), and 15% versus 6% at 3 months (OR = 2.93; 95% CI: 0.90 to 9.59). Increases in acceptance of internal cues to smoke mediated the effect of treatment on smoking cessation at 12 months. iCanQuit arm participants were also significantly more engaged and satisfied with their assigned application.
CONCLUSIONS


In a nationwide sample with high data retention and participant engagement, this is the first study to show that a digital intervention may be efficacious for helping American Indians and Alaska Natives quit smoking.
IMPLICATIONS


This is the first study to provide evidence of an efficacious, accessible, and engaging treatment for helping American Indians and Alaska Natives quit smoking. Compared to a US Clinical Practice Guidelines-based smartphone application (QuitGuide), an ACT-based smartphone application (iCanQuit) was more efficacious, engaging, and satisfactory among American Indians and Alaska Natives nationwide. Our results will inform the tailoring of the iCanQuit smartphone application for American Indian and Alaska Native tribal communities and organizations with potential for broad dissemination and high impact.",2022,"The 30-day PPA for iCanQuit vs. QuitGuide was 30% vs. 18% at 12-months (OR=1.96; 95% CI: 0.90, 4.26) 25% vs. 11% at 6-months","['trial participants enrolled in the iCanQuit trial', 'American Indians and Alaska Natives', 'Randomized American Indians and Alaska Natives from 31 US states (70% urban, 30% rural, with 25% of participants residing on tribal land', 'n=89) and QuitGuide (n=80']","['Smartphone Applications', 'USCPG-based smartphone application (QuitGuide), an ACT-based smartphone application (iCanQuit', 'Acceptance and Commitment Therapy (ACT)-based smartphone application (iCanQuit) vs. US Clinical Practice Guidelines based smartphone application (QuitGuide']","['outcome data retention rates', 'self-reported, complete-case, 30-day point-prevalence abstinence (PPA', '30-day PPA']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0557668', 'cui_str': 'Landing'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0282451', 'cui_str': 'Clinical Practice Guideline'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.114521,"The 30-day PPA for iCanQuit vs. QuitGuide was 30% vs. 18% at 12-months (OR=1.96; 95% CI: 0.90, 4.26) 25% vs. 11% at 6-months","[{'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Santiago-Torres', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Mull', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Brianna M', 'Initials': 'BM', 'LastName': 'Sullivan', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Kwon', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Nez Henderson', 'Affiliation': 'Black Hills Center for American Indian Health, Rapid City, SD, USA.'}, {'ForeName': 'Lonnie A', 'Initials': 'LA', 'LastName': 'Nelson', 'Affiliation': 'Initiative for Research and Education to Advance Community Health, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Christi A', 'Initials': 'CA', 'LastName': 'Patten', 'Affiliation': 'Department of Psychiatry and Psychology and Behavioral Health Research Program, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Bricker', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab213']
1097,34651206,Effects of oral iodine supplementation in very low birth weight preterm infants for the prevention of thyroid function alterations during the neonatal period: results of a randomised assessor-blinded pilot trial and neurodevelopmental outcomes at 24 months.,"The trace element iodine (I) is essential for the synthesis of thyroid hormones. Parenteral nutrition solutions, formula milk, and human breast milk contain insufficient iodine to meet recommended intake for preterm infants. Iodine deficiency may affect thyroid function and may be associated with morbidity or neurological outcomes. The primary objective is to assess the evidence that dietary supplementation with iodine affects thyroid function during the neonatal period. The design was a randomised controlled pilot trial. Infants who met the inclusion criteria were enrolled through consecutive sampling and assigned to two different groups. The setting was a Spanish university hospital. Ninety-four patients with very low birth weight (under 1500 g) were included. Intervention group: 30 µg I/kg/day of iodine in oral drops given to 47 infants from their first day of life until hospital discharge. Control group: 47 infants without supplements. Formula and maternal milk samples for the determination of iodine content were collected at 1, 7, 15, 21, 30 days, and at discharge. Blood samples were collected for thyroid hormones. Neurological development was assessed at 2 years of age (Bayley III Test). Infants in the supplemented group reached the recommended levels from the first days of life. The researchers detected the effects of iodine balance on the plasma levels of thyroid hormones measured during the first 12 weeks of age. The trial assessed the impact of the intervention on neurodevelopmental morbidity.Conclusion: Thyroid function is related to iodine intake in preterm infants. Therefore, supplements should be added if iodine intake is found to be inadequate. The analyses found no effects of iodine supplementation on the composite scores for Bayley-III assessments in all major domains. The study results indicate potentially important effects on language development related to low iodine excretion during the first 4 weeks of life What is Known: • Thyroid function is related to iodine intake in preterm infants. • Preterm babies on formula preparations and with exclusive parenteral nutrition are at high risk of iodine deficiency. What is New: • Iodine intake should be monitored during the neonatal period. • Iodine supplements should be added if iodine intake is found to be inadequate.",2022,The analyses found no effects of iodine supplementation on the composite scores for Bayley-III assessments in all major domains.,"['preterm infants', 'Ninety-four patients with very low birth weight (under 1500\xa0g) were included', 'Control group: 47 infants without supplements', 'very low birth weight preterm infants', 'Infants who met the inclusion criteria']","['Parenteral nutrition solutions, formula milk, and human breast milk contain insufficient iodine', 'iodine supplementation', 'dietary supplementation with iodine', 'Iodine supplements', 'oral iodine supplementation', 'Intervention group: 30\xa0µg I/kg/day of iodine', 'iodine balance']","['plasma levels of thyroid hormones', 'Neurological development', 'thyroid function alterations', 'neurodevelopmental morbidity']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0717967', 'cui_str': 'Solutions for parenteral nutrition'}, {'cui': 'C0452742', 'cui_str': 'Formula milk'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C3661599', 'cui_str': 'Iodine supplement'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439418', 'cui_str': 'kg/day'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",94.0,0.0202623,The analyses found no effects of iodine supplementation on the composite scores for Bayley-III assessments in all major domains.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ares', 'Affiliation': 'Neonatology Unit, University Hospital LA PAZ, Paseo de la Castellana 261, 28046, Madrid, Spain. susana.ares@salud.madrid.org.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Saenz-Rico', 'Affiliation': 'Facultad de Educacion, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Arnaez', 'Affiliation': 'Neonatology Unit, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Diez-Sebastian', 'Affiliation': 'Biostatistics Department, University Hospital LA PAZ, Paseo de la Castellana 261, 28046, Madrid, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Omeñaca', 'Affiliation': 'Neonatology Unit, University Hospital LA PAZ, Paseo de la Castellana 261, 28046, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bernal', 'Affiliation': 'Instituto de Investigaciones Biomédicas, Universidad Autónoma de Madrid, Arturo Duperier 4, Madrid, Spain.'}]",European journal of pediatrics,['10.1007/s00431-021-04288-5']
1098,34652810,Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis.,"BACKGROUND


Risankizumab has demonstrated efficacy and safety in patients with moderate-to-severe plaque psoriasis in randomized clinical trials.
OBJECTIVES


To evaluate safety data from risankizumab psoriasis phase I-III clinical trials.
METHODS


Short-term safety (through week 16) was analysed using integrated data from five phase II and III clinical trials. Long-term safety was evaluated using integrated data from 17 phase I-III completed and ongoing trials.
RESULTS


Short-term safety analyses included 1306 patients receiving risankizumab 150 mg and 300 patients receiving placebo [402·2 and 92·0 patient-years (PY) of exposure, respectively]. Long-term analyses included 3072 risankizumab-treated patients (exposure: 7927 PY). The median (excluding four outliers) treatment duration was 2·9 years (range 2 days to 5·9 years). Exposure-adjusted adverse event rates did not increase with long-term treatment (318 vs. 171 events per 100 PY for short- and long-term analyses). With long-term risankizumab treatment, rates of serious adverse events were 7·8 per 100 PY, serious infections 1·2 per 100 PY, nonmelanoma skin cancer (NMSC) 0·7 per 100 PY, malignant tumours excluding NMSC 0·5 per 100 PY, and adjudicated major adverse cardiovascular events 0·3 per 100 PY, with no important identified risks. Limitations include that the study inclusion and exclusion criteria varied and that three studies enrolled ≤ 50 patients.
CONCLUSIONS


Risankizumab demonstrated a favourable safety profile over short- and long-term treatment in patients with moderate-to-severe psoriasis.",2021,"With long-term risankizumab treatment, rates of serious AEs were 7.8/100 PY, serious infections, 1.2/100 PY, non-melanoma skin cancer (NMSC), 0.7/100 PY, malignant tumors excluding NMSC, 0.5/100 PY, and adjudicated major adverse cardiovascular events, 0.3/100 PY, with no important identified risks.","['Patients With Moderate-to-Severe Plaque Psoriasis', '3072 risankizumab-treated patients (exposure: 7927.2 PY); median (range, excluding 4 outliers) treatment duration was 2.9 years (2 days-5.9 years', 'patients with moderate-to-severe psoriasis', '1306 patients receiving', 'patients with moderate-to-severe plaque psoriasis']","['risankizumab', 'placebo', 'Risankizumab']","['Exposure-adjusted adverse event (AE) rates', 'rates of serious AEs', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.149402,"With long-term risankizumab treatment, rates of serious AEs were 7.8/100 PY, serious infections, 1.2/100 PY, non-melanoma skin cancer (NMSC), 0.7/100 PY, malignant tumors excluding NMSC, 0.5/100 PY, and adjudicated major adverse cardiovascular events, 0.3/100 PY, with no important identified risks.","[{'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Department of Dermatology, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bachelez', 'Affiliation': 'Hôpital Saint-Louis, AP-HP, Université de Paris, Paris, France.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Wu', 'Affiliation': 'Dermatology Research and Education Foundation, Irvine, CA, USA.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Langley', 'Affiliation': 'Division of Dermatology, Department of Medicine, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kaplan', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sinvhal', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.20818']
1099,34669956,A Randomized Trial of Nicotine versus No-nicotine E-cigarettes Among African American Smokers: Changes in Smoking and Tobacco Biomarkers.,"INTRODUCTION


The objective of this clinical trial was to compare the effects of e-cigarettes with and without nicotine on patterns of combustible cigarette use and biomarkers of exposure to tobacco toxicants among African American smokers.
METHODS


African American smokers (n = 234) were enrolled in a 12-week, single blind, randomized controlled trial and assigned to ad lib use of nicotine e-cigarettes with or without menthol (2.4% nicotine [equivalent to combustible cigarettes], n = 118), or no-nicotine e-cigarettes (n = 116) for 6 weeks. Surveys were administered at baseline, 2, 6, and 12 weeks, and urinary biomarkers 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) and total nicotine equivalents (TNE) were assessed at baseline and 6 weeks.
RESULTS


Participants smoked an average of 11.4 cigarettes per day (CPD) and 88% used menthol cigarettes at baseline. At Week 6, the nicotine group reported using e-cigarettes 9.1 times per day compared to 11.4 times in the no-nicotine group (p = 0.42). Combustible cigarette smoking decreased 3.0 CPD in the nicotine group compared to 2.7 CPD in the no-nicotine group (p = 0.74). Neither TNE nor NNAL changed significantly between baseline and Week 6. There were no differences in nicotine withdrawal symptoms between treatment groups. Smoking reduction persisted in both groups at Week 12.
CONCLUSIONS


Contrary to our hypotheses, nicotine e-cigarettes did not significantly reduce the use of combustible cigarettes compared to no-nicotine e-cigarettes in this cohort of African American smokers. Findings suggest e-cigarettes are modestly associated with the decreased use of combustible cigarettes among non-treatment seeking smokers, regardless of nicotine content, but without a reduction in tobacco toxicants.
IMPLICATIONS


Although e-cigarettes have the potential to reduce harm if substituted for combusted cigarettes (or if they promoted cessation) because of lower levels of tobacco toxicants, this study suggests ad lib use of e-cigarettes among African American smokers, with or without nicotine, results in modest smoking reduction but does not change toxicant exposure in a cohort where smoking cessation or reduction is not the goal. These data suggest that testing future harm reduction interventions using e-cigarettes should include more specific behavioral change coaching, including substituting for or completely stopping combusted cigarettes.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov - NCT03084315.",2022,"Contrary to our hypotheses, nicotine e-cigarettes did not significantly reduce the use of combustible cigarettes compared to no-nicotine e-cigarettes in this cohort of African American smokers.","['African American smokers (n=234', 'African American smokers']","['e-cigarettes with and without nicotine', 'nicotine vs. no-nicotine e-cigarettes', 'nicotine e-cigarettes', 'nicotine e-cigarettes with or without menthol (2.4% nicotine [equivalent to combustible cigarettes], n=118), or no-nicotine e-cigarettes', 'nicotine']","['Combustible cigarette smoking', 'Smoking reduction', 'nicotine withdrawal symptoms', 'TNE nor NNAL', 'urinary biomarkers 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) and total nicotine equivalents (TNE', 'combustible cigarettes']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0389836', 'cui_str': '4-(methylnitrosamino)-1-(3-pyridyl)-1-butan-1-ol'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",234.0,0.096035,"Contrary to our hypotheses, nicotine e-cigarettes did not significantly reduce the use of combustible cigarettes compared to no-nicotine e-cigarettes in this cohort of African American smokers.","[{'ForeName': 'Kolawole S', 'Initials': 'KS', 'LastName': 'Okuyemi', 'Affiliation': 'Department of Family and Preventive Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Olamide', 'Initials': 'O', 'LastName': 'Ojo-Fati', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Taiwo O', 'Initials': 'TO', 'LastName': 'Aremu', 'Affiliation': 'Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Samantha C', 'Initials': 'SC', 'LastName': 'Friedrichsen', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Grude', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Mosunmoluwa', 'Initials': 'M', 'LastName': 'Oyenuga', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shyne', 'Affiliation': 'Biostatistical Design and Analysis Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Department of Biochemistry, Molecular Biology, and Biophysics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Hatsukami', 'Affiliation': 'Department of Psychiatry, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Joseph', 'Affiliation': 'Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab212']
1100,34669645,Impact of conventional vs. goal-directed fluid therapy on urethral tissue perfusion in patients undergoing liver surgery: A pilot randomised controlled trial.,"BACKGROUND


Although fluid administration is a key strategy to optimise haemodynamic status and tissue perfusion, optimal fluid administration during liver surgery remains controversial.
OBJECTIVE


To test the hypothesis that a goal-directed fluid therapy (GDFT) strategy, when compared with a conventional fluid strategy, would better optimise systemic blood flow and lead to improved urethral tissue perfusion (a new variable to assess peripheral blood flow), without increasing blood loss.
DESIGN


Single-centre prospective randomised controlled superiority study.
SETTING


Erasme Hospital.
PATIENTS


Patients undergoing liver surgery.
INTERVENTION


Forty patients were randomised into two groups: all received a basal crystalloid infusion (maximum 2 ml kg-1 h-1). In the conventional fluid group, the goal was to maintain central venous pressure (CVP) as low as possible during the dissection phase by giving minimal additional fluid, while in the posttransection phase, anaesthetists were free to compensate for any presumed fluid deficit. In the GDFT group, patients received in addition to the basal infusion, multiple minifluid challenges of crystalloid to maintain stroke volume (SV) variation less than 13%. Noradrenaline infusion was titrated to keep mean arterial pressure more than 65 mmHg in all patients.
MAIN OUTCOME MEASURE


The mean intra-operative urethral perfusion index.
RESULTS


The mean urethral perfusion index was significantly higher in the GDFT group than in the conventional fluid group (8.70 [5.72 to 13.10] vs. 6.05 [4.95 to 8.75], P = 0.046). SV index (ml m-2) and cardiac index (l min-1 m-2) were higher in the GDFT group (48 ± 9 vs. 33 ± 7 and 3.5 ± 0.7 vs. 2.4 ± 0.4, respectively; P < 0.001). Although CVP was higher in the GDFT group (9.3 ± 2.5 vs. 6.5 ± 2.9 mmHg; P = 0.003), intra-operative blood loss was not significantly different in the two groups.
CONCLUSION


In patients undergoing liver surgery, a GDFT strategy resulted in a higher mean urethral perfusion index than did a conventional fluid strategy and did not increase blood loss despite higher CVP.
TRIAL REGISTRATION


NCT04092608.",2022,"In patients undergoing liver surgery, a GDFT strategy resulted in a higher mean urethral perfusion index than did a conventional fluid strategy and did not increase blood loss despite higher CVP.
","['patients undergoing liver surgery', 'Forty patients', 'Erasme Hospital', 'Patients undergoing liver surgery']","['Noradrenaline', 'basal crystalloid infusion (maximum 2\u200aml\u200akg-1\u200ah-1', 'conventional vs. goal-directed fluid therapy', 'GDFT']","['blood loss', 'mean arterial pressure', 'SV index (ml\u200am-2) and cardiac index', 'intra-operative blood loss', 'mean intra-operative urethral perfusion index', 'urethral tissue perfusion', 'mean urethral perfusion index', 'CVP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0193373', 'cui_str': 'Operation on liver'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C2964282', 'cui_str': 'Perfusion Index'}, {'cui': 'C0429877', 'cui_str': 'Tissue perfusion measure'}, {'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}]",40.0,0.387763,"In patients undergoing liver surgery, a GDFT strategy resulted in a higher mean urethral perfusion index than did a conventional fluid strategy and did not increase blood loss despite higher CVP.
","[{'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Chirnoaga', 'Affiliation': 'From the Department of Anaesthesiology, Erasme University Hospital, Université Libre de Bruxelles, Brussels (DC, SC, BI, LVO, AJ), Unit of Hepatobiliary Surgery and Liver Transplantation, Department of Digestive Surgery, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium (VL), Department of Anesthesiology, Sauvegarde Clinic, Ramsay Santé, Lyon, France (OD), Department of Anesthesiology and Pain Medicine, Université de Montréal, Centre de recherche du CHUM, Montreal, Québec, Canada (F-MC), MiCo, Denens, Switzerland (FM), Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium (J-LV), Department of Anaesthesiology and Intensive Care, Assistance Publique Hôpitaux de Paris, Paris-Saclay University, Bicetre Hospital, Paris, France (JD) and Department of Anaesthesiology, Brugmann Hospital, Université Libre de Bruxelles, Brussels, Belgium (PVdL).'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Coeckelenbergh', 'Affiliation': ''}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Ickx', 'Affiliation': ''}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Van Obbergh', 'Affiliation': ''}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Lucidi', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Desebbe', 'Affiliation': ''}, {'ForeName': 'François Martin', 'Initials': 'FM', 'LastName': 'Carrier', 'Affiliation': ''}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Michard', 'Affiliation': ''}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Vincent', 'Affiliation': ''}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Duranteau', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Van der Linden', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Joosten', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001615']
1101,34650034,Toripalimab plus chemotherapy as second-line treatment in previously EGFR-TKI treated patients with EGFR-mutant-advanced NSCLC: a multicenter phase-II trial.,"This multicenter phase-II trial aimed to investigate the efficacy, safety, and predictive biomarkers of toripalimab plus chemotherapy as second-line treatment in patients with EGFR-mutant-advanced NSCLC. Patients who failed from first-line EGFR-TKIs and did not harbor T790M mutation were enrolled. Toripalimab plus carboplatin and pemetrexed were administrated every three weeks for up to six cycles, followed by the maintenance of toripalimab and pemetrexed. The primary endpoint was objective-response rate (ORR). Integrated biomarker analysis of PD-L1 expression, tumor mutational burden (TMB), CD8 + tumor-infiltrating lymphocyte (TIL) density, whole-exome, and transcriptome sequencing on tumor biopsies were also conducted. Forty patients were enrolled with an overall ORR of 50.0% and disease-control rate (DCR) of 87.5%. The median progression free survival (PFS) and overall survival were 7.0 and 23.5 months, respectively. The most common treatment-related adverse effects were leukopenia, neutropenia, anemia, ALT/AST elevation, and nausea. Biomarker analysis showed that none of PD-L1 expression, TMB level, and CD8 + TIL density could serve as a predictive biomarker. Integrated analysis of whole-exome and transcriptome sequencing data revealed that patients with DSPP mutation had a decreased M2 macrophage infiltration and associated with longer PFS than those of wild type. Toripalimab plus chemotherapy showed a promising anti-tumor activity with acceptable safety profiles as the second-line setting in patients with EGFR-mutant NSCLC. DSPP mutation might serve as a potential biomarker for this combination. A phase-III trial to compare toripalimab versus placebo in combination with chemotherapy in this setting is ongoing (NCT03924050).",2021,"The most common treatment-related adverse effects were leukopenia, neutropenia, anemia, ALT/AST elevation, and nausea.","['Patients who failed from first-line EGFR-TKIs and did not harbor T790M mutation were enrolled', 'patients with EGFR-mutant-advanced NSCLC', 'Forty patients were enrolled with an overall ORR of 50.0% and disease-control rate (DCR) of 87.5', 'patients with EGFR-mutant NSCLC', 'previously EGFR-TKI treated patients with EGFR-mutant-advanced NSCLC', 'patients with DSPP mutation']","['toripalimab plus chemotherapy', 'toripalimab versus placebo', 'Toripalimab plus chemotherapy', 'Toripalimab plus carboplatin and pemetrexed']","['objective-response rate (ORR', 'M2 macrophage infiltration', 'median progression free survival (PFS) and overall survival', 'leukopenia, neutropenia, anemia, ALT/AST elevation, and nausea', 'PD-L1 expression, TMB level, and CD8\u2009+\u2009TIL density', 'PD-L1 expression, tumor mutational burden (TMB), CD8\u2009+\u2009tumor-infiltrating lymphocyte (TIL) density, whole-exome, and transcriptome sequencing on tumor biopsies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C3178814', 'cui_str': 'Exomes'}, {'cui': 'C4086963', 'cui_str': 'Complete Transcriptome Sequencing'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",40.0,0.0532244,"The most common treatment-related adverse effects were leukopenia, neutropenia, anemia, ALT/AST elevation, and nausea.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Pingyang', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Cell Biology, Innovation Center for Cell Signaling Network, CAS Center for Excellence in Molecular Cell Science, Shanghai Institute of Biochemistry and Cell Biology, Chinese Academy of Sciences, University of Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yanqiu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'The Fifth Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Helong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Guanghui', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': 'Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Mu', 'Affiliation': 'Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Bao', 'Affiliation': 'The First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Renhua', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'The Fifth Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': ""Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Ningqiang', 'Initials': 'N', 'LastName': 'Ma', 'Affiliation': ""Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yalei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'Shanghai Junshi Biosciences Co. Ltd, Shanghai, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Shanghai Junshi Biosciences Co. Ltd, Shanghai, China.'}, {'ForeName': 'Jiarui', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory of Cell Biology, Innovation Center for Cell Signaling Network, CAS Center for Excellence in Molecular Cell Science, Shanghai Institute of Biochemistry and Cell Biology, Chinese Academy of Sciences, University of Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Luonan', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. lnchen@sibs.ac.cn.'}, {'ForeName': 'Caicun', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. caicunzhou_dr@163.com.'}, {'ForeName': 'Shengxiang', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. harry_ren@126.com.'}]",Signal transduction and targeted therapy,['10.1038/s41392-021-00751-9']
1102,34648847,Short- and long-term effects of different exercise programs on the gait performance of older adults with subjective cognitive decline: A randomized controlled trial.,"BACKGROUND


Older adults, especially those with cognitive decline, often have poor gait performance, which results in poor clinical outcomes due to falls or decreased daily physical activity. The effects of various exercises on gait performance have been studied, whereas the short-term and long-term effects of different exercise modalities remain unknown.
OBJECTIVE


To compare the short- and long-term effects of aerobic training (AT), resistance training (RT), and combined training (CT) on the gait performance of community-dwelling older adults with subjective cognitive decline (SCD).
DESIGN


A four-arm, randomized controlled trial.
SETTING AND SUBJECTS


388 community-dwelling older adults with SCD (mean age, 72.3 years).
METHODS


Participants attended an exercise or education class twice a week for 26 weeks. 10 gait performance parameters were examined at baseline, post-intervention (Week 26), and after 26 weeks of follow-up (Week 52) using an electronic walkway system.
RESULTS


The mean adherence of exercise sessions was 82.5 to 85.9%. All exercise intervention induced an improvement in gait speed, stride time, cadence, stride length, and double-support time at Week 26 (p < .05), without significant intergroup differences among exercise interventions. However, only RT showed a significant effect on some spatiotemporal gait parameters at Week 52. The analyses for the gait variability parameters showed mild effects of all exercise interventions.
CONCLUSION


All of the exercise programs examined had a positive short-term effect on spatiotemporal gait parameters of older adults with SCD, despite no effect on gait variability parameters. RT are most recommended when long-lasting effects are the primary aim.",2021,"All exercise intervention induced an improvement in gait speed, stride time, cadence, stride length, and double-support time at Week 26 (p < .05), without significant intergroup differences among exercise interventions.","['older adults with SCD', 'Participants attended an exercise or education class twice a week for 26\u202fweeks', 'Older adults', '388 community-dwelling older adults with SCD (mean age, 72.3\u202fyears', 'community-dwelling older adults with subjective cognitive decline (SCD', 'older adults with subjective cognitive decline']","['aerobic training (AT), resistance training (RT), and combined training (CT', 'exercise programs', 'various exercises']","['spatiotemporal gait parameters', 'gait performance', 'mean adherence of exercise sessions', 'gait speed, stride time, cadence, stride length, and double-support time']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",388.0,0.0295963,"All exercise intervention induced an improvement in gait speed, stride time, cadence, stride length, and double-support time at Week 26 (p < .05), without significant intergroup differences among exercise interventions.","[{'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan; Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Umegaki', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan; Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Taeko', 'Initials': 'T', 'LastName': 'Makino', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Uemura', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Inoue', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Chiharu', 'Initials': 'C', 'LastName': 'Uno', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Kitada', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Chi Hsien', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan; Department of Family Medicine, E-Da Hospital, Kaohsiung City, Taiwan, ROC.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Shimada', 'Affiliation': 'Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kuzuya', 'Affiliation': 'Institute of Innovation for Future Society, Nagoya University, Nagoya, Japan; Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: kuzuya@med.nagoya-u.ac.jp.'}]",Experimental gerontology,['10.1016/j.exger.2021.111590']
1103,34655181,"Blood Pressure Recovery After Dobutamine Antagonism: Partial With Landiolol, None With Esmolol.","We investigated the hemodynamic effects of 2 short-acting β 1  -blockers, landiolol and esmolol, in the continuous presence of dobutamine in a prospective, single-center, randomized, crossover study in 16 healthy White volunteers. Dobutamine was infused at a rate sufficient to increase the heart rate by at least 30 beats per minute, followed by a 60-minute infusion of 50 μg/kg/min esmolol or 10 μg/kg/min landiolol on top of the unchanged dobutamine infusion. Concentrations of β-blockers and their metabolites in blood, heart rate, and blood pressure were followed for 180 minutes. Landiolol reduced the dobutamine-induced heart rate and blood pressure increases better than esmolol. After discontinuation of β-blocker administration, heart rate recovered swiftly to preinfusion values in both study arms. Systolic and diastolic blood pressure recovered partially after landiolol but showed a continued reduction after esmolol. No serious adverse events were observed. The heart rate effect is characteristic for β-blockers, whereas the blood pressure effects are likely due to direct and indirect β-blocker effects as well as influences on various ion channels. This may explain why landiolol that is devoid of effects on renin and sodium, calcium, and potassium channels behaves different from esmolol with respect to blood pressure recovery.",2022,No serious adverse events were observed.,['16 healthy White volunteers'],"['Dobutamine', 'Esmolol', 'esmolol', '2 short-acting β 1  -blockers, landiolol and esmolol']","['heart rate', 'Blood Pressure Recovery', 'heart rate and blood pressure', 'serious adverse events', 'blood pressure effects', 'Systolic and diastolic blood pressure', 'hemodynamic effects', 'Concentrations of β-blockers and their metabolites in blood, heart rate, and blood pressure']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0012963', 'cui_str': 'Dobutamine'}, {'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0905464', 'cui_str': 'landiolol'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",16.0,0.0453444,No serious adverse events were observed.,"[{'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Krumpl', 'Affiliation': 'MRN Medical Research Network GmbH, Vienna, Austria.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Ulč', 'Affiliation': 'Center for Pharmacology and Analysis (CEPHA) s.r.o., Plzeň, Czech Republic.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Trebs', 'Affiliation': 'AOP Orphan Pharmaceuticals GmbH, Vienna, Austria.'}, {'ForeName': 'Pavla', 'Initials': 'P', 'LastName': 'Kadlecová', 'Affiliation': 'Advanced Drug Development Services (ADDS) s.r.o., Brno, Czech Republic.'}, {'ForeName': 'Juri', 'Initials': 'J', 'LastName': 'Hodisch', 'Affiliation': 'AOP Orphan Pharmaceuticals GmbH, Vienna, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Husch', 'Affiliation': 'AOP Orphan Pharmaceuticals GmbH, Vienna, Austria.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.1025']
1104,34653721,Effectiveness of local anesthetic application methods in postoperative pain control in laparoscopic cholecystectomies; a randomised controlled trial.,"BACKGROUND


Laparoscopic cholecystectomy is a minimally invasive procedure that causes pain originating from parietal and visceral peritoneum. Many studies have been conducted to improve postoperative pain management and comfort of patients. Various methods such as local anesthetic injection (LAI) at trocar access points, intraperitoneal local anesthetic injection (IPLA), pneumoperitoneum pressure reduction, transversus abdominis plane block (TAPB), and reducing the number of trocars used during the operation were attempted to reduce postoperative pain.
METHODS


In this study, we compared LAI, TAPB and IPLA methods with the control group in which no local anesthetic was applied to reduce postoperative pain after laparoscopic cholecystectomy. We also demonstrated the effect of these methods on postoperative pain, need for additional analgesics, length of hospitalization, and patient satisfaction.
RESULTS


Overall, 160 patients aged 18-74 years who underwent laparoscopic cholecystectomy for cholelithiasis between October 2018 and August 2019 were included in the study and divided into four groups as follows: LAI group, TAPB group, IPLA group, and the control group without any intervention. Visual Analog Scale (VAS) values at 1, 2, 4, 6, 12, and 24 h in the control group were significantly higher than in the LAI, TAPB, and IPLA groups. Further, VAS values at 1, 2, 4, 6, 12, and 24 h in the IPLA group were significantly higher than in the LAI and TAPB groups. No significant difference was observed between the LAI and TAPB groups in terms of VAS values at 1, 2, 4, 6, and 24 h. VAS values at 12 h in the LAI group were significantly higher than in the TAPB group.
CONCLUSIONS


Peroperative local anesthetic administration methods were more effective in preventing pain after laparoscopic cholecystectomy compared to the control group. In addition to reducing postoperative pain, these methods reduced the need for postoperative analgesics and increased patient satisfaction.",2021,"No significant difference was observed between the LAI and TAPB groups in terms of VAS values at 1, 2, 4, 6, and 24 h. VAS values at 12 h in the LAI group were significantly higher than in the TAPB group.
","['laparoscopic cholecystectomies', '160 patients aged 18-74 years who underwent', 'for cholelithiasis between October 2018 and August 2019 were included in the study and divided into four groups as follows']","['TAPB', 'laparoscopic cholecystectomy', 'local anesthetic injection (LAI) at trocar access points, intraperitoneal local anesthetic injection (IPLA), pneumoperitoneum pressure reduction, transversus abdominis plane block (TAPB', 'local anesthetic application methods', 'IPLA', 'Laparoscopic cholecystectomy']","['postoperative pain control', 'postoperative pain', 'postoperative pain, need for additional analgesics, length of hospitalization, and patient satisfaction', 'VAS values', 'pain', 'Visual Analog Scale (VAS) values']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C2830173', 'cui_str': 'Calcium-Independent Phospholipase A2'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",160.0,0.0741714,"No significant difference was observed between the LAI and TAPB groups in terms of VAS values at 1, 2, 4, 6, and 24 h. VAS values at 12 h in the LAI group were significantly higher than in the TAPB group.
","[{'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Ergin', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: dranilergin@gmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Timuçin Aydin', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: mtimucina@gmail.com.'}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Çiyiltepe', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: drciyiltepe@gmail.com.'}, {'ForeName': 'Aziz Bora', 'Initials': 'AB', 'LastName': 'Karip', 'Affiliation': 'Istanbul Oncology Hospital, Digestive Surgery Department, Cevizli, Toros Street No:86, 34846, Maltepe, İstanbul, Turkey. Electronic address: borakarip@gmail.com.'}, {'ForeName': 'Mehmet Mahir', 'Initials': 'MM', 'LastName': 'Fersahoğlu', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: fersahoglu@yahoo.com.'}, {'ForeName': 'Yetkin', 'Initials': 'Y', 'LastName': 'Özcabi', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: yetkin-oz@hotmail.com.'}, {'ForeName': 'Birol', 'Initials': 'B', 'LastName': 'Ağca', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: birolagca@yahoo.com.'}, {'ForeName': 'Ahmet Yalin', 'Initials': 'AY', 'LastName': 'İşcan', 'Affiliation': 'Istanbul Unıversity Faculty of Medicine, General Surgery Department, Topkapı, Turgut Özal Millet Street, 34093, Fatih, İstanbul, Turkey. Electronic address: yaliniscan@gmail.com.'}, {'ForeName': 'Yasin', 'Initials': 'Y', 'LastName': 'Güneş', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: drysngunes@hotmail.com.'}, {'ForeName': 'Arzu Yildirim', 'Initials': 'AY', 'LastName': 'Ar', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, Department of Anesthesiology and Reanimation, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752, Turkey. Electronic address: dr.arzuyildirim@hotmail.com.'}, {'ForeName': 'İksan', 'Initials': 'İ', 'LastName': 'Taşdelen', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: mftasdelen@gmail.com.'}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Memi Şoğlu', 'Affiliation': 'Fatih Sultan Mehmet Training and Research Hospital, General Surgery Department, Hastane Street No: 1/8 Icerenkoy, Istanbul, 34752 , Turkey. Electronic address: cerrah@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2021.106134']
1105,34655547,Selective laser trabeculoplasty versus 0·5% timolol eye drops for the treatment of glaucoma in Tanzania: a randomised controlled trial.,"BACKGROUND


Glaucoma is a major cause of sight loss worldwide, with the highest regional prevalence and incidence reported in Africa. The most common low-cost treatment used to control glaucoma is long-term timolol eye drops. However, low adherence is a major challenge. We aimed to investigate whether selective laser trabeculoplasty (SLT) was superior to timolol eye drops for controlling intraocular pressure (IOP) in patients with open-angle glaucoma.
METHODS


We did a two-arm, parallel-group, single-masked randomised controlled trial at the Eye Department of Kilimanjaro Christian Medical Centre, Moshi, Tanzania. Eligible participants (aged ≥18 years) had open-angle glaucoma and an IOP above 21 mm Hg, and did not have asthma or a history of glaucoma surgery or laser. Participants were randomly assigned (1:1) to receive 0·5% timolol eye drops to administer twice daily or to receive SLT. The primary outcome was the proportion of eyes from both groups with treatment success, defined as an IOP below or equal to target pressure according to glaucoma severity, at 12 months following randomisation. Re-explanation of eye drop application or a repeat SLT was permitted once. The primary analysis was by modified intention-to-treat, excluding participants lost to follow-up, using logistic regression; generalised estimating equations were used to adjust for the correlation between eyes. This trial was registered with the Pan African Clinical Trials Registry, number PACTR201508001235339.
FINDINGS


840 patients were screened for eligibility, of whom 201 (24%) participants (382 eligible eyes) were enrolled between Aug 31, 2015, and May 12, 2017. 100 (50%) participants (191 eyes) were randomly assigned to the timolol group and 101 (50%; 191 eyes) to the SLT group. After 1 year, 339 (89%) of 382 eyes were analysed. Treatment was successful in 55 (31%) of 176 eyes in the timolol group (16 [29%] of 55 eyes required repeat administration counselling) and in 99 (61%) of 163 eyes in the SLT group (33 [33%] of 99 eyes required repeat SLT; odds ratio 3·37 [95% CI 1·96-5·80]; p<0·0001). Adverse events (mostly unrelated to ocular events) occurred in ten (10%) participants in the timolol group and in eight (8%) participants in the SLT group (p=0·61).
INTERPRETATION


SLT was superior to timolol eye drops for managing patients with open-angle high-pressure glaucoma for 1 year in Tanzania. SLT has the potential to transform the management of glaucoma in sub-Saharan Africa, even where the prevalence of advanced glaucoma is high.
FUNDING


Christian Blind Mission, Seeing is Believing Innovation Fund, and the Wellcome Trust.
TRANSLATIONS


For the Kiswahili, French and Portuguese translations of the abstract see Supplementary Materials section.",2021,"Adverse events (mostly unrelated to ocular events) occurred in ten (10%) participants in the timolol group and in eight (8%) participants in the SLT group (p=0·61).
","['840 patients were screened for eligibility, of whom 201 (24%) participants (382 eligible eyes) were enrolled between Aug 31, 2015, and May 12, 2017', 'patients with open-angle glaucoma', '100 (50%) participants (191 eyes', 'glaucoma in Tanzania', 'Eligible participants (aged ≥18 years) had open-angle glaucoma and an IOP above 21 mm Hg, and did not have asthma or a history of glaucoma surgery or laser']","['SLT', 'timolol eye drops', 'selective laser trabeculoplasty (SLT', '0·5% timolol eye drops to administer twice daily or to receive SLT', 'timolol', 'Selective laser trabeculoplasty versus 0·5% timolol eye drops']","['repeat administration counselling', 'intraocular pressure (IOP', 'proportion of eyes from both groups with treatment success, defined as an IOP below or equal to target pressure according to glaucoma severity', 'Adverse events']","[{'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0455517', 'cui_str': 'H/O: glaucoma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C1271447', 'cui_str': 'Selective laser trabeculoplasty'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",840.0,0.220938,"Adverse events (mostly unrelated to ocular events) occurred in ten (10%) participants in the timolol group and in eight (8%) participants in the SLT group (p=0·61).
","[{'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Philippin', 'Affiliation': 'International Centre for Eye Health, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK; Eye Department, Kilimanjaro Christian Medical Centre, Moshi, Tanzania; Eye Centre, Medical Centre-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. Electronic address: heiko.philippin@lshtm.ac.uk.'}, {'ForeName': 'Einoti', 'Initials': 'E', 'LastName': 'Matayan', 'Affiliation': 'Eye Department, Kilimanjaro Christian Medical Centre, Moshi, Tanzania; Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Knoll', 'Affiliation': 'Eye Department, Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Macha', 'Affiliation': 'Eye Department, Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Sia', 'Initials': 'S', 'LastName': 'Mbishi', 'Affiliation': 'Eye Department, Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Makupa', 'Affiliation': 'Eye Department, Kilimanjaro Christian Medical Centre, Moshi, Tanzania; Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Cristóvão', 'Initials': 'C', 'LastName': 'Matsinhe', 'Affiliation': 'Eye Department, Kilimanjaro Christian Medical Centre, Moshi, Tanzania; Provincial Hospital of Pemba, Pemba, Mozambique.'}, {'ForeName': 'Vasco', 'Initials': 'V', 'LastName': 'da Gama', 'Affiliation': 'Eye Department, Kilimanjaro Christian Medical Centre, Moshi, Tanzania; Hospital Central de Quelimane, Quelimane, Mozambique.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Monjane', 'Affiliation': 'Eye Department, Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Awum Joyce', 'Initials': 'AJ', 'LastName': 'Ncheda', 'Affiliation': 'Eye Department, Kilimanjaro Christian Medical Centre, Moshi, Tanzania; Presbyterian Eye Hospital, Bafoussam, Cameroon.'}, {'ForeName': 'Francisco Alcides', 'Initials': 'FA', 'LastName': 'Mulobuana', 'Affiliation': 'Eye Department, Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Elisante', 'Initials': 'E', 'LastName': 'Muna', 'Affiliation': 'Eye Department, Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Fopoussi', 'Affiliation': 'Eye Department, Kilimanjaro Christian Medical Centre, Moshi, Tanzania; Cameroon Baptist Convention Health Services, Douala, Cameroon.'}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Gazzard', 'Affiliation': 'NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust-University College London Institute of Ophthalmology, London, UK; University College London Institute of Ophthalmology, London, UK.'}, {'ForeName': 'Ana Patricia', 'Initials': 'AP', 'LastName': 'Marques', 'Affiliation': 'International Centre for Eye Health, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; University College London Institute of Ophthalmology, London, UK; Birmingham Institute for Glaucoma Research, Institute of Translational Medicine, University Hospitals Birmingham, Birmingham, UK; Centre for Health and Social Care Improvement, University of Wolverhampton, Wolverhampton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Macleod', 'Affiliation': 'MRC International Statistics and Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'William U', 'Initials': 'WU', 'LastName': 'Makupa', 'Affiliation': 'Eye Department, Kilimanjaro Christian Medical Centre, Moshi, Tanzania; Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Burton', 'Affiliation': 'International Centre for Eye Health, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK; NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust-University College London Institute of Ophthalmology, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(21)00348-X']
1106,34670789,"Comment on Rosenstock et al. Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial. Diabetes Care 2020;43:2509-2518.",,2021,,['Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy'],"['Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide']",[],"[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C2607479', 'cui_str': 'albiglutide'}]",[],,0.0601344,,"[{'ForeName': 'Chinmay S', 'Initials': 'CS', 'LastName': 'Marathe', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide, Australia chinmay.marathe@adelaide.edu.au.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Rayner', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Tongzhi', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide, Australia.'}]",Diabetes care,['10.2337/dc20-2987']
1107,34677609,Effect of Transcranial Direct Current Brain Stimulation of the Motor Cortex on Chemotherapy-Induced Nausea and Vomiting in Female Patients with Breast Cancer.,"OBJECTIVE


Chemotherapy-induced nausea and vomiting (CINV) is an adverse outcome associated with chemotherapy and is sometimes difficult to manage. This study aimed to examine the impact of a single session of transcranial direct current brain stimulation (tDCS; 2 mA) over the motor cortex for 20 minutes before chemotherapy in patients receiving a highly emetogenic chemotherapy.
STUDY DESIGN


Prospective randomized double-blind sham-controlled study.
SETTING


Academic medical center.
METHOD


Sixty patients with breast cancer who were scheduled for chemotherapy treatment were selected and allocated randomly into two equal groups: a stimulation group and a sham group. tDCS was implemented over the primary motor area (M1) (2 mA) for 20 minutes. Patients' nausea was measured by a cumulative index of nausea, a visual analog scale for nausea (VAS-N), episodes of vomiting, and the Edmonton Symptoms Assessment Scale (ESAS) to assess symptoms like pain, malaise, and sense of well-being. Evaluation was done before stimulation and every 24 hours for 72 hours after the end of infusion of chemotherapy.
RESULTS


The tDCS group showed a reduction in the cumulative index of nausea (P < 0.001, F = 50), the VAS-N (P < 0.001, F = 52), the ESAS malaise score (P < 0.001, F = 37.6), and the sense of well-being score (P < 0.001, F = 25) vs the sham group. Six patients (20%) in the tDCS group required rescue antiemtic therapy vs 14 patients (46.7%) in the sham group (P < 0.028).
CONCLUSION


A single session of M1 tDCS is suggested as an effective adjuvant therapy to control CINV in female patients suffering from breast cancer and receiving highly emetogenic chemotherapy. Corroboratory studies are needed.",2022,"RESULTS


Real tDCS group showed reduction of cumulative index of nausea (P < 0.001, F = 50), VAS-N (P < 0.001, F = 52) and for ESAS in malaise score (P < 0.001, F = 37.6) and sense of wellbeing score (P < 0.001, F = 25) than sham group.","['female patients with breast cancer', 'female patients suffers from breast cancer who obtained highly emetogenic chemotherapy', 'Sixty breast cancer patients prepared for chemotherapy treatment', 'Academic medical center']","['transcranial direct current brain stimulation', 'single-session tDCS (2\u2009mA']","['nausea and vomiting (CINV', 'cumulative index of nausea and visual analog scale for nausea (VAS-N), and vomiting by cumulative index of episodes of vomiting, and Edmonton symptoms Assessment Scale (ESAS) to assess symptoms like pain, malaise, and sense of well-being', 'nausea and vomiting', 'sense of wellbeing score', 'ESAS in malaise score', 'nausea', 'cumulative index of nausea']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.149545,"RESULTS


Real tDCS group showed reduction of cumulative index of nausea (P < 0.001, F = 50), VAS-N (P < 0.001, F = 52) and for ESAS in malaise score (P < 0.001, F = 37.6) and sense of wellbeing score (P < 0.001, F = 25) than sham group.","[{'ForeName': 'Shereen Mamdouh', 'Initials': 'SM', 'LastName': 'Kamal', 'Affiliation': 'South Egypt Cancer Institute, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Nayria Mahmoud', 'Initials': 'NM', 'LastName': 'Elhusseini', 'Affiliation': 'South Egypt Cancer Institute, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mayada Fawzy', 'Initials': 'MF', 'LastName': 'Sedik', 'Affiliation': 'South Egypt Cancer Institute, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamad F', 'Initials': 'MF', 'LastName': 'Mohamad', 'Affiliation': 'South Egypt Cancer Institute, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Eman Mohamed Hussein', 'Initials': 'EMH', 'LastName': 'Khedr', 'Affiliation': 'Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Hassan Ibraheem Mohamed', 'Initials': 'HIM', 'LastName': 'Kotb', 'Affiliation': 'Faculty of Medicine, Assiut University, Assiut, Egypt.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnab313']
1108,34674966,"Effectiveness and safety of motion style acupuncture treatment of the pelvic joint for herniated lumbar disc with radiating pain: A prospective, observational pilot study.","CONTEXT


Conservative treatment is effective for treating and managing herniated lumbar disc with radiating leg pain.
OBJECTIVES


To investigate the effects of motion style acupuncture treatment (MSAT) on the pelvic joint for this condition.
DESIGN


This prospective observational study was a pilot study for a future randomized, controlled trial (RCT).
SETTING


[masked for review].
PATIENTS/INTERVENTIONS


We enroled 40 patients and allocated them to two groups (both n = 20). Groups 1 and 2 received integrative Korean medicine treatment (KMT) and integrative KMT with MSAT for pelvic joint, respectively. Primary outcome was the Numeric Rating Scale (NRS) score for low back pain. Secondary outcomes were the Oswestry Disability Index (ODI), Visual analogue Scale (VAS), and EuroQol 5-Dimension-5-level (EQ-5D-5 L) scores. Efficacy was assessed by comparing the baseline and Day 4 results. Safety was assessed based on the frequency and severity of all adverse events.
RESULTS


On Day 14, except for ODI in Group 1, the NRS, VAS, and EQ-5D-5 L scores showed significant improvements in both groups. On Day 90, both groups showed significant improvements in the NRS, ODI, and EQ-5D-5 L scores. There was a significant between-group difference in the NRS score on Day 7. On Day 14, Group 2 had a significantly lower VAS score for radiating leg pain than Group 1. Twelve patients reported adverse events associated with integrative KMT; however, there was no association with pelvic joint MSAT.
CONCLUSION


Adding MSAT for pelvic joint to conventional integrative KMT may ameliorate radiating leg pain and improve the quality of life.",2022,"On Day 90, both groups showed significant improvements in the NRS, ODI, and EQ-5D-5 L scores.",['herniated lumbar disc with radiating pain'],"['integrative Korean medicine treatment (KMT) and integrative KMT with MSAT', 'motion style acupuncture', 'motion style acupuncture treatment (MSAT', 'MSAT']","['radiating leg pain', 'quality of life', 'NRS score', 'NRS, ODI, and EQ-5D-5\xa0L scores', 'NRS, VAS, and EQ-5D-5', 'VAS score', 'Efficacy', 'frequency and severity of all adverse events', 'Oswestry Disability Index (ODI), Visual analogue Scale (VAS), and EuroQol 5-Dimension-5-level', 'Numeric Rating Scale (NRS) score for low back pain']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0234254', 'cui_str': 'Radiating pain'}]","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0332301', 'cui_str': 'Radiating to'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]",40.0,0.0388581,"On Day 90, both groups showed significant improvements in the NRS, ODI, and EQ-5D-5 L scores.","[{'ForeName': 'Je-Heon', 'Initials': 'JH', 'LastName': 'Noh', 'Affiliation': 'Daejeon Jaseng Hospital of Korean Medicine, Republic of Korea.'}, {'ForeName': 'Da-Young', 'Initials': 'DY', 'LastName': 'Byun', 'Affiliation': 'Daejeon Jaseng Hospital of Korean Medicine, Republic of Korea.'}, {'ForeName': 'Si-Hoon', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Daejeon Jaseng Hospital of Korean Medicine, Republic of Korea.'}, {'ForeName': 'Jeongyoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Daejeon Jaseng Hospital of Korean Medicine, Republic of Korea.'}, {'ForeName': 'Ji-Ae', 'Initials': 'JA', 'LastName': 'Roh', 'Affiliation': 'Daejeon Jaseng Hospital of Korean Medicine, Republic of Korea.'}, {'ForeName': 'Min-Young', 'Initials': 'MY', 'LastName': 'Kim', 'Affiliation': 'Daejeon Jaseng Hospital of Korean Medicine, Republic of Korea.'}, {'ForeName': 'Su-Na', 'Initials': 'SN', 'LastName': 'Kim', 'Affiliation': 'Daejeon Jaseng Hospital of Korean Medicine, Republic of Korea.'}, {'ForeName': 'Eun-San', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 3F JS Tower, 538 Gangnam-daero, Gangnam-gu, Seoul, 06110, Republic of Korea.'}, {'ForeName': 'Kyoung Sun', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 3F JS Tower, 538 Gangnam-daero, Gangnam-gu, Seoul, 06110, Republic of Korea; Jaseng Hospital of Korean Medicine, Republic of Korea.'}, {'ForeName': 'Jinho', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Jaseng Hospital of Korean Medicine, Republic of Korea.'}, {'ForeName': 'In-Hyuk', 'Initials': 'IH', 'LastName': 'Ha', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 3F JS Tower, 538 Gangnam-daero, Gangnam-gu, Seoul, 06110, Republic of Korea. Electronic address: hanihata@jaseng.org.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2021.09.004']
1109,34676680,Cutaneous microvascular vasodilatory consequences of acute consumption of a caffeinated soft drink sweetened with high-fructose corn syrup.,"This study tested the hypotheses that compared to drinking water, consumption of a caffeinated soft drink sweetened with high-fructose corn syrup (HFCS) attenuates the cutaneous vasodilatory response to local skin heating without (Protocol 1) and following ischemia-reperfusion injury (Protocol 2). In a randomized, counterbalanced crossover design, 14 healthy adults (25 ± 3 year, 6 women) consumed 500 ml of water (water) or a caffeinated soft drink sweetened with HFCS (Mtn. Dew, DEW). Thirty minutes following beverage consumption local skin heating commenced on the right forearm (Protocol 1), while on the left forearm ischemia-reperfusion commenced with 20 min of ischemia followed by 20 min of reperfusion and then local skin heating (Protocol 2). Local skin heating involved 40 min of heating to 39℃ followed by 20 min of heating to 44℃. Skin blood flow (SkBf, laser Doppler) data were normalized to mean arterial pressure and are presented as a cutaneous vascular conductance (CVC) and as percentage of the CVC response during heating to 44℃ (%CVC max  ). Protocol 1: During local heating at 39℃, no differences were observed in CVC (water: 2.0 ± 0.6 PU/mmHg; DEW: 2.0 ± 0.8 PU/mmHg, p = 0.83) or %CVC max  (water: 59 ± 14%; DEW 60 ± 15%, p = 0.84) between trials. Protocol 2: During local skin heating at 39℃, no differences were observed in CVC (water: 1.7 ± 0.5 PU/mmHg; DEW: 1.5 ± 0.5 PU/mmHg, p = 0.33) or %CVC max  (water: 64 ± 15%; DEW 61 ± 15% p = 0.62) between trials. The cutaneous microvascular vasodilator response to local heating with or without prior ischemia-reperfusion injury is not affected by acute consumption of a caffeinated soft drink sweetened with HFCS.",2021,The cutaneous microvascular vasodilator response to local heating with or without prior ischemia-reperfusion injury is not affected by acute consumption of a caffeinated soft drink sweetened with HFCS.,"['14\xa0healthy adults (25\xa0±\xa03\xa0year, 6 women']","['beverage consumption local skin heating', 'caffeinated soft drink sweetened with high-fructose corn syrup', 'caffeinated soft drink sweetened with high-fructose corn syrup (HFCS', 'consumed 500\xa0ml of water (water) or a caffeinated soft drink sweetened with HFCS (Mtn', 'Local skin heating involved 40\xa0min of heating to 39℃ followed by 20\xa0min of heating']","['Skin blood flow (SkBf, laser Doppler) data']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C3489624', 'cui_str': 'Soda Pop'}, {'cui': 'C2981326', 'cui_str': 'High Fructose Corn Syrup'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0430489', 'cui_str': 'Laser doppler'}]",,0.033278,The cutaneous microvascular vasodilator response to local heating with or without prior ischemia-reperfusion injury is not affected by acute consumption of a caffeinated soft drink sweetened with HFCS.,"[{'ForeName': 'Joel T', 'Initials': 'JT', 'LastName': 'Greenshields', 'Affiliation': 'H.H. Morris Human Performance Laboratories, Department of Kinesiology, School of Public Health, Indiana University, Bloomington, Indiana, USA.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Keeler', 'Affiliation': 'H.H. Morris Human Performance Laboratories, Department of Kinesiology, School of Public Health, Indiana University, Bloomington, Indiana, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Freemas', 'Affiliation': 'H.H. Morris Human Performance Laboratories, Department of Kinesiology, School of Public Health, Indiana University, Bloomington, Indiana, USA.'}, {'ForeName': 'Tyler B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'H.H. Morris Human Performance Laboratories, Department of Kinesiology, School of Public Health, Indiana University, Bloomington, Indiana, USA.'}, {'ForeName': 'Blair D', 'Initials': 'BD', 'LastName': 'Johnson', 'Affiliation': 'H.H. Morris Human Performance Laboratories, Department of Kinesiology, School of Public Health, Indiana University, Bloomington, Indiana, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Carter', 'Affiliation': 'H.H. Morris Human Performance Laboratories, Department of Kinesiology, School of Public Health, Indiana University, Bloomington, Indiana, USA.'}, {'ForeName': 'Zachary J', 'Initials': 'ZJ', 'LastName': 'Schlader', 'Affiliation': 'H.H. Morris Human Performance Laboratories, Department of Kinesiology, School of Public Health, Indiana University, Bloomington, Indiana, USA.'}]",Physiological reports,['10.14814/phy2.15074']
1110,34674021,Effect of continuous passive motion on the early recovery outcomes after total knee arthroplasty.,"INTRODUCTION


Continuous passive motion (CPM) is a frequently used method in the early post-operative rehabilitation of patients after knee surgery. In this study, the effectiveness of the CPM method was evaluated after primary total knee arthroplasty during an early recovery period.
METHODS


Eighty patients undergoing total knee arthroplasty were assigned into two groups. The experimental group received CPM and active exercises, while the control group active exercises only. All subjects were evaluated once before the surgery and at a discharge, in terms of mean active range of motion (AROM), mean Knee Society Score (KSS), and Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC).
RESULTS


The mean AROM for the experimental group was 82.3° ± 14.3° and 76.1° ± 22.2° for the control. The mean KSS score was 136.4 ± 19.3 points for the experimental group, and 135.7 ± 15.1 for the control. There were no statistical differences between the two groups. The KSS functional score was 66.4 ± 8.1 points for the experimental group compared to 62.2 ± 7.3 points for the control, but there was a statistically significant difference between the groups at discharge from the hospital (p = 0.009). A subjective estimation of the pain level, joint stiffness and function also showed a statistically significant difference between the two groups (38.6 ± 14.3 points for the CPM group and 21.2 ± 15.7 for the control).
CONCLUSION


These findings show that there is no significant effect of CPM in terms of improving clinical measurements. However, there was a significant beneficial effect on the subjective assessment of pain level, joint stiffness, and functional ability.",2022,"A subjective estimation of the pain level, joint stiffness and function also showed a statistically significant difference between the two groups (38.6 ± 14.3 points for the CPM group and 21.2 ± 15.7 for the control).
","['Eighty patients undergoing total knee arthroplasty', 'total knee arthroplasty', 'patients after knee surgery']","['Continuous passive motion (CPM', 'continuous passive motion', 'CPM and active exercises, while the control group active exercises only']","['KSS functional score', 'mean KSS score', 'pain level, joint stiffness and function', 'mean active range of motion (AROM), mean Knee Society Score (KSS), and Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC', 'mean AROM', 'subjective assessment of pain level, joint stiffness, and functional ability']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0419117', 'cui_str': 'Active exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",80.0,0.0269089,"A subjective estimation of the pain level, joint stiffness and function also showed a statistically significant difference between the two groups (38.6 ± 14.3 points for the CPM group and 21.2 ± 15.7 for the control).
","[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Richter', 'Affiliation': 'Department of Orthopedics and Traumatology, Poznan University of Medical Sciences, 28 Czerwca 1956 r. 135/147, 61-545, Poznan, Poland. mrichter@ump.edu.pl.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Trzeciak', 'Affiliation': 'Department of Orthopedics and Traumatology, Poznan University of Medical Sciences, 28 Czerwca 1956 r. 135/147, 61-545, Poznan, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Kaczmarek', 'Affiliation': 'Department of Orthopedics and Traumatology, Poznan University of Medical Sciences, 28 Czerwca 1956 r. 135/147, 61-545, Poznan, Poland.'}]",International orthopaedics,['10.1007/s00264-021-05245-5']
1111,34677005,The effectiveness of the information-motivation model and domestic brushing with a hypochlorite-based formula on peri-implant mucositis: A randomized clinical study.,"OBJECTIVE


Management of mucositis is essential for the long-term maintenance of dental implants. This study determined the efficacy, in terms of clinical parameters, of an adjunctive domiciliary agent paired with non-surgical periodontal therapy (NSPT) for patients with peri-implant mucositis.
MATERIALS AND METHODS


Patients involved in a periodontal maintenance program were randomly distributed to the domestic use of a chlorhexidine toothpaste and mouthwash (control) or a hypochlorite-based formula brushing solution (test) after diagnosis of peri-implant mucositis. A modified approach towards NSPTwas performed after 10 days of domestic use of the assigned maintenance product in both groups. Clinical and patient-related outcomes were recorded during a 90-day follow-up period.
RESULTS


Forty patients completed the three-month study (20 patients per group). Both groups showed relevant clinical and patient outcome improvements after the NSPT (T2) and between T1 and T2 (p < 0 0.01), except for PPD. For the test group, the clinical improvement was significantly greater than that for the control group at the seventh-day evaluation (T 1  ) in the gingival index (0-3) and FMBS (%). Favorable outcomes were maintained during the entire follow-up period.
CONCLUSION


The present study showed that the modified NSPT paired with the domestic use of nitradine-based formula helps resolve peri-implant mucositis and that nitradine might represent an alternative to chlorhexidine in these cases.
CLINICAL RELEVANCE


The gold standard for nonsurgical maintenance is full-mouth disinfection. A previous decontamination of the oral cavity with chlorhexidine or nitradine domiciliary for 10 days could reduce plaque and inflammation, resulting in a painless operative session. This protocol may help reduce airborne contamination and the risk of cross-infection, and during the pandemic, the protocol is safer for clinicians. In the same clinical cases, nitradine may be more efficient than chlorhexidine, and the former has no side effects such as discolouration.",2022,"For the test group, the clinical improvement was significantly greater than that for the control group at the seventh-day evaluation (T 1  ) in the gingival index (0-3) and FMBS (%).","['Forty patients completed the three-month study (20 patients per group', 'patients with peri-implant mucositis', 'Patients involved in a periodontal maintenance program']","['information-motivation model and domestic brushing with a hypochlorite-based formula', 'chlorhexidine toothpaste and mouthwash (control) or a hypochlorite-based formula brushing solution', 'adjunctive domiciliary agent paired with non-surgical periodontal therapy (NSPT', 'chlorhexidine']","['clinical improvement', 'peri-implant mucositis', 'plaque and inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C0122922', 'cui_str': 'Hypochlorite'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0338047', 'cui_str': 'Domiciliary'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",40.0,0.0357106,"For the test group, the clinical improvement was significantly greater than that for the control group at the seventh-day evaluation (T 1  ) in the gingival index (0-3) and FMBS (%).","[{'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cosola', 'Affiliation': 'Department of Stomatology, Tuscan Stomatologic Institute, Foundation for Continuing Education and Dental Research, Camaiore (LU), Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Oldoini', 'Affiliation': 'Department of Stomatology, Tuscan Stomatologic Institute, Foundation for Continuing Education and Dental Research, Camaiore (LU), Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Giammarinaro', 'Affiliation': 'Department of Stomatology, Tuscan Stomatologic Institute, Foundation for Continuing Education and Dental Research, Camaiore (LU), Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Covani', 'Affiliation': 'Department of Stomatology, Tuscan Stomatologic Institute, Foundation for Continuing Education and Dental Research, Camaiore (LU), Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Genovesi', 'Affiliation': 'Department of Stomatology, Tuscan Stomatologic Institute, Foundation for Continuing Education and Dental Research, Camaiore (LU), Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Marconcini', 'Affiliation': 'Department of Stomatology, Tuscan Stomatologic Institute, Foundation for Continuing Education and Dental Research, Camaiore (LU), Italy.'}]",Clinical and experimental dental research,['10.1002/cre2.487']
1112,34686621,"""You Kick Like A Girl!"" The Effects of Gender Stereotypes on Motor Skill Learning in Young Adolescents.","This study investigated the effect of gender stereotypes on (a) a soccer learning task based on accuracy (i.e., shooting on different size targets) among young adolescents and (b) the strategy used to score as many points as possible. After performing 10 baseline trials, 45 young adolescents were randomly divided into three groups: positive stereotype, negative stereotype, and control. Then, they performed five blocks of 10 trials and two retention tests, 1 and 3 days after the stereotype manipulation to assess the relatively permanent consequences of stereotype effects. Results showed that when the negative stereotype was induced, participants performed worse during the acquisition phase and the first retention test. The positive stereotype only had a positive effect on performance during the second retention test. These findings provide the first evidence of the effect of gender stereotypes on motor learning tasks requiring accuracy among young adolescents.",2021,"Results showed that when the negative stereotype was induced, participants performed worse during the acquisition phase and the first retention test.","['45 young adolescents', 'Young Adolescents', 'young adolescents']","['Gender Stereotypes', 'gender stereotypes on (a)\xa0a soccer learning task', 'positive stereotype, negative stereotype, and control']","['Motor Skill Learning', 'negative stereotype']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}]",45.0,0.106466,"Results showed that when the negative stereotype was induced, participants performed worse during the acquisition phase and the first retention test.","[{'ForeName': 'Seyyed Mohammadreza', 'Initials': 'SM', 'LastName': 'Mousavi', 'Affiliation': 'College of Sport Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': ""Côte d'Azur University, Nice, France.""}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Beik', 'Affiliation': 'University of Urmia, Urmia, Iran.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Deshayes', 'Affiliation': 'University of Nîmes, Nîmes, France.'}]",Journal of sport & exercise psychology,['10.1123/jsep.2020-0255']
1113,34672937,A prostate cancer risk calculator: Use of clinical and magnetic resonance imaging data to predict biopsy outcome in North American men.,"INTRODUCTION


A functional tool to optimize patient selection for magnetic resonance imaging (MRI)-guided prostate biopsy (MRGB) is an unmet clinical need. We sought to develop a prostate cancer risk calculator (PCRC-MRI) that combines MRI and clinical characteristics to aid decision-making for MRGB in North American men.
METHODS


Two prospective registries containing 2354 consecutive men undergoing MRGB (September 2009 to April 2019) were analyzed. Patients were randomized into five groups, with one group randomly assigned to be the validation cohort against the other four groups as the discovery cohort. The primary outcome was detection of clinically significant prostate cancer (csPCa) defined as Gleason grade group ≥2. Variables included age, ethnicity, digital rectal exam (DRE), prior biopsy, prostate-specific antigen (PSA), prostate volume, PSA density, and MRI score. Odds ratios (OR) were calculated from multivariate logistic regression comparing two models: one with clinical variables only (clinical) against a second combining clinical variables with MRI data (clinical+MRI).
RESULTS


csPCa was present in 942 (40%) of the 2354 men available for study. The positive and negative predictive values for csPCa in the clinical+MRI model were 57% and 89%, respectively. The area under the curve of the clinical+MRI model was superior to the clinical model in discovery (0.843 vs. 0.707, p<0.0001) and validation (0.888 vs. 0.757, p<0.0001) cohorts. Use of PCRC-MRI would have avoided approximately 16 unnecessary biopsies in every 100 men. Of all variables examined, Asian ethnicity was the most protective factor (OR 0.46, 0.29-0.75) while MRI score 5 indicated greatest risk (OR15.8, 10.5-23.9).
CONCLUSIONS


A risk calculator (PCRC-MRI), based on a large North American cohort, is shown to improve patient selection for MRGB, especially in preventing unnecessary biopsies. This tool is available at https://www.uclahealth.org/urology/prostate-cancer-riskcalculator and may help rationalize biopsy decision-making.",2022,"Of all variables examined, Asian ethnicity was the most protective factor (odds ratio [OR] 0.46 [0.29-0.75]) while MRI score 5 indicated greatest risk (OR15.8 [10.5-23.9]).
","['North American men', 'A prostate cancer risk calculator (PCRC-MRI', '2354 men available for study', '2354 consecutive men undergoing MRGB (September 2009 to April 2019']","['magnetic resonance imaging data', 'magnetic resonance imaging (MRI)-guided prostate biopsy (MRGB', 'PCRC-MRI', 'prostate cancer risk calculator (PCRC-MRI']","['MRI score', 'detection of clinically significant prostate cancer (csPCa', 'age, ethnicity, digital rectal exam (DRE), prior biopsy, prostate-specific antigen (PSA), prostate volume, PSA density, and MRI score', 'Odds ratios']","[{'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0870240', 'cui_str': 'Calculator'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0870240', 'cui_str': 'Calculator'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0199900', 'cui_str': 'Rectal examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",2354.0,0.226664,"Of all variables examined, Asian ethnicity was the most protective factor (odds ratio [OR] 0.46 [0.29-0.75]) while MRI score 5 indicated greatest risk (OR15.8 [10.5-23.9]).
","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kinnaird', 'Affiliation': 'Department of Urology, David Geffen School of Medicine, UCLA, Los Angeles, CA, United States.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Brisbane', 'Affiliation': 'Department of Urology, David Geffen School of Medicine, UCLA, Los Angeles, CA, United States.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Kwan', 'Affiliation': 'Department of Urology, David Geffen School of Medicine, UCLA, Los Angeles, CA, United States.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Priester', 'Affiliation': 'Department of Bioengineering, UCLA, Los Angeles, CA, United States.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Chuang', 'Affiliation': 'Department of Urology, David Geffen School of Medicine, UCLA, Los Angeles, CA, United States.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Barsa', 'Affiliation': 'Department of Urology, David Geffen School of Medicine, UCLA, Los Angeles, CA, United States.'}, {'ForeName': 'Merdie', 'Initials': 'M', 'LastName': 'Delfin', 'Affiliation': 'Department of Urology, David Geffen School of Medicine, UCLA, Los Angeles, CA, United States.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Sisk', 'Affiliation': 'Department of Pathology & Laboratory Medicine, UCLA, Los Angeles, CA, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Margolis', 'Affiliation': 'Department of Radiology, Weill Cornell Medical College, New York, NY, United States.'}, {'ForeName': 'Ely', 'Initials': 'E', 'LastName': 'Felker', 'Affiliation': 'Department of Radiological Sciences, UCLA, Los Angeles, CA, United States.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Urology, Weill Cornell Medical College, New York, NY, United States.'}, {'ForeName': 'Leonard S', 'Initials': 'LS', 'LastName': 'Marks', 'Affiliation': 'Department of Urology, David Geffen School of Medicine, UCLA, Los Angeles, CA, United States.'}]",Canadian Urological Association journal = Journal de l'Association des urologues du Canada,['10.5489/cuaj.7380']
1114,34687810,Randomised methodology development study to investigate plaque removal efficacy of manual toothbrushes.,"OBJECTIVES


This study aimed to evaluate plaque removal efficacy of toothbrushes to guide clinical model development.
METHODS


This single-centre, randomised, controlled, examiner-blind, method development study included 80 healthy participants. Over 28 days, participants brushed twice-daily using a fluoride toothpaste and one of four marketed toothbrushes: Toothbrushes A (compact head) and B (regular head): medium-hard; flat trim; end-rounded bristles; Toothbrush C: medium-hard; end-rounded bristles; silky, tapered filaments; compact head; Toothbrush D: soft; tapered filaments; compact head. Supra-gingival plaque removal was evaluated immediately after single brushing events (Days 0, 7, 28, at study centre) and following 7- and 28-days' home use via Rustogi modified Navy Plaque Index (RPI) and Turesky modified Quigley Hein Plaque Index (TPI).
RESULTS


All toothbrushes provided significant plaque removal after single-brushing events with change from Day 0 pre-brushing scores on RPI ranging from -0.10 to -0.16 (p<.0001) and on TPI ranging from -0.61 to -0.89 (p<.0001). Toothbrushes A and B showed significant (p<.05) pre-brushing RPI/TPI plaque reductions after 7- (-0.04/-0.06, respectively for RPI; -0.16/-0.20, respectively for TPI) and 28-days (-0.04/-0.03, respectively for RPI; -0.20/-0.11, respectively for TPI) use versus Day 0 pre-brushing (except Toothbrush B, Day 28, non-significant TPI). There were no significant differences with Toothbrush C. Toothbrush D TPI was significantly lower at both timepoints versus Day 0 pre-brushing (p<.05). Study toothbrushes were generally well-tolerated.
CONCLUSION


The observations from this study showed how various aspects of a study design could impact toothbrushes performance. These data will inform the design of future clinical studies of plaque removal efficacy using manual toothbrushes.
CLINICAL SIGNIFICANCE STATEMENT


Regular effective oral hygiene can help prevent and treat gingivitis, principally via twice-daily mechanical cleaning with a toothbrush. Data generated from this methodology development study will help to identify the key aspects which impact toothbrushes' performance and understand which one would be more suitable to answer questions of scientific interest. This study provides useful information for the design of future clinical trials to assess plaque removal efficacy of manual toothbrushes and generate results to inform clinical recommendations.",2022,"Toothbrushes A and B showed significant (p<.05) pre-brushing RPI/TPI plaque reductions after 7- and 28-days use versus Day 0 pre-brushing (except Toothbrush B, Day 28, non-significant TPI).",['80 healthy participants'],"['fluoride toothpaste and one of four marketed toothbrushes: Toothbrushes A (compact head) and B (regular head): medium-hard; flat trim; end-rounded bristles; Toothbrush C: medium-hard; end-rounded bristles; silky, tapered filaments; compact head; Toothbrush D: soft; tapered filaments; compact head', 'manual toothbrushes', ""7- and 28-days' home use via Rustogi modified Navy Plaque Index (RPI) and Turesky modified Quigley Hein Plaque Index (TPI""]","['tolerated', 'Supra-gingival plaque removal', 'pre-brushing RPI/TPI plaque reductions', 'Toothbrush C. Toothbrush D TPI', 'plaque-removal efficacy', 'plaque removal']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0441645', 'cui_str': 'Trimming - action'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0010851', 'cui_str': 'Cytoskeletal Filaments'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0490733', 'cui_str': 'Manual toothbrush'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",80.0,0.0862604,"Toothbrushes A and B showed significant (p<.05) pre-brushing RPI/TPI plaque reductions after 7- and 28-days use versus Day 0 pre-brushing (except Toothbrush B, Day 28, non-significant TPI).","[{'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Grimaldi', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, KT13 0DE, United Kingdom.""}, {'ForeName': 'Zehra', 'Initials': 'Z', 'LastName': 'Yonel', 'Affiliation': 'Institute of Clinical Sciences, College of Medical & Dental Sciences, The University of Birmingham, United Kingdom.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Chapple', 'Affiliation': 'Raven Lane Consulting Ltd, Wirral, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Butler', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, KT13 0DE, United Kingdom.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hall', 'Affiliation': 'Raven Lane Consulting Ltd, Wirral, United Kingdom.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Reinbold', 'Affiliation': ""Oral & Skin Health. GSK Consumer Healthcare, St George's Avenue, Weybridge, KT13 0DE, United Kingdom.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Mantzourani', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, KT13 0DE, United Kingdom. Electronic address: maria.x.mantzourani@gsk.com.""}]",Journal of dentistry,['10.1016/j.jdent.2021.103830']
1115,34687316,Adjuvant Rituximab-Exploratory Trial in Young People With Graves Disease.,"CONTEXT


Remission rates in young people with Graves hyperthyroidism are less than 25% after 2 years of thionamide antithyroid drug (ATD).
OBJECTIVE


We explored whether rituximab (RTX), a B-lymphocyte-depleting agent, would increase remission rates when administered with a short course of ATD.
METHODS


This was an open-label, multicenter, single-arm, phase 2 trial in young people (ages, 12-20 years) with Graves hyperthyroidism. An A'Hern design was used to distinguish an encouraging remission rate (40%) from an unacceptable rate (20%). Participants presenting with Graves hyperthyroidism received 500 mg RTX and 12 months of ATD titrated according to thyroid function. ATDs were stopped after 12 months and primary outcome assessed at 24 months. Participants had relapsed at 24 months if thyrotropin was suppressed and free 3,5,3'-triiodothyronine was raised; they had received ATD between months 12 and 24; or they had thyroid surgery/radioiodine.
RESULTS


A total of 27 participants were recruited and completed the trial with no serious side effects linked to treatment. Daily carbimazole dose at 12 months was less than 5 mg in 21 of 27 participants. Thirteen of 27 participants were in remission at 24 months (48%, 90% one-sided CI, 35%-100%); this exceeded the critical value (9) for the A'Hern design and provided evidence of a promising remission rate. B-lymphocyte count at 28 weeks, expressed as a percentage of baseline, was related to likelihood of remission.
CONCLUSION


Adjuvant RTX, administered with a 12-month course of ATD, may increase the likelihood of remission in young people with Graves hyperthyroidism. A randomized trial of adjuvant RTX in young people with Graves hyperthyroidism is warranted.",2022,"13/27 participants were in remission at 24 months (48%, 90% one-sided confidence interval 35%, 100%); this exceeded the critical value (9) for the A'Hern design and provided evidence of a promising remission rate.","[""young people with Graves' hyperthyroidism"", ""Participants presenting with Graves' hyperthyroidism"", 'Twenty-seven participants', ""young people (12-20y) with Graves' hyperthyroidism"", ""young people with Graves' disease"", ""young people with Graves' hyperthyroidism are <25% after two years of thionamide antithyroid drug (ATD""]","['thyroid surgery/radioiodine', 'adjuvant rituximab', 'rituximab', 'Adjuvant Rituximab']","['remission rate', 'remission rates', 'B lymphocyte count', 'likelihood of remission']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020550', 'cui_str': 'Hyperthyroidism'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040125', 'cui_str': 'Antithyroid agent'}]","[{'cui': 'C0193769', 'cui_str': 'Operation on thyroid gland'}, {'cui': 'C2828294', 'cui_str': 'iodide ion I-131'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1167996', 'cui_str': 'B lymphocyte count'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",27.0,0.280579,"13/27 participants were in remission at 24 months (48%, 90% one-sided confidence interval 35%, 100%); this exceeded the critical value (9) for the A'Hern design and provided evidence of a promising remission rate.","[{'ForeName': 'Tim D', 'Initials': 'TD', 'LastName': 'Cheetham', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, International Centre for Life, Newcastle upon Tyne, NE1 3BZ, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cole', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Abinun', 'Affiliation': 'Immunity & Inflammation Theme, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Allahabadia', 'Affiliation': 'Academic Directorate of Diabetes and Endocrinology, Royal Hallamshire Hospital, Sheffield, S10 2JF, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Barratt', 'Affiliation': ""University of Birmingham, Diabetes Unit, Birmingham Children's Hospital, Birmingham, B4 6NH, UK.""}, {'ForeName': 'Justin H', 'Initials': 'JH', 'LastName': 'Davies', 'Affiliation': 'Department of Paediatric Endocrinology, Faculty of Medicine, University of Southampton, University Hospital Southampton NHS Foundation Trust, Southampton, SO16 6YD, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dimitri', 'Affiliation': ""The Department of Paediatric Endocrinology, Sheffield Children's NHS Trust, Western Bank, Sheffield, S10 2TH, UK.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Drake', 'Affiliation': ""Centre for Cardiovascular Science, Queen's Medical Research Institute, Edinburgh, EH16 4TJ, UK.""}, {'ForeName': 'Zainaba', 'Initials': 'Z', 'LastName': 'Mohamed', 'Affiliation': ""Birmingham Children's Hospital, Birmingham, B46NH, UK.""}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Murray', 'Affiliation': 'Leeds Centre for Diabetes and Endocrinology, Leeds Teaching Hospitals NHS Trust, Leeds, LS97TF, UK.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Steele', 'Affiliation': 'Children and Adolescent services, Leeds Teaching Hospitals NHS Trust, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Zammitt', 'Affiliation': 'Edinburgh Centre for Endocrinology & Diabetes, Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, UK.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Carnell', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, NE2 4AE, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Prichard', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, NE2 4AE, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Watson', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, NE2 4AE, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hambleton', 'Affiliation': 'Immunity & Inflammation Theme, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'John N S', 'Initials': 'JNS', 'LastName': 'Matthews', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK.'}, {'ForeName': 'Simon H S', 'Initials': 'SHS', 'LastName': 'Pearce', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, International Centre for Life, Newcastle upon Tyne, NE1 3BZ, UK.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab763']
1116,34687308,The Effect of Adding Dry Needling to Physical Therapy in the Treatment of Cervicogenic Headache: A Randomized Controlled Trial.,"OBJECTIVE


To compare the long-term effect of adding real or sham dry needling with conventional physiotherapy in cervicogenic headache.
DESIGN


A randomized controlled trial.
SETTING


Physiotherapy Clinic, Rouhani Hospital of Babol University of Medical Sciences, Iran.
SUBJECTS


Sixty-nine patients with cervicogenic headache.
METHODS


Patients were randomly assigned into a control group (n = 23) receiving conventional physical therapy; a dry needling group (n = 23) receiving conventional physical therapy and dry needling on the cervical muscles; placebo needling group (n = 23) receiving conventional physical therapy and superficial dry needling at a point away from the trigger point. The primary outcome was the headache intensity and frequency. Neck disability, deep cervical flexor performance, and range of motion were secondary outcomes. Outcomes were assessed immediately after treatment and 1, 3, and 6 months later.
RESULTS


Sixty-five patients were finally included in the analysis. Headache intensity and neck disability decreased significantly more in the dry needling compared to sham and control groups after treatment and during all follow-ups. The frequency of headaches also reduced more in the dry needling than in control and sham groups, but it did not reach statistical significance. Higher cervical range of motion and enhancement of deep cervical flexors performance was also observed in the dry needling compared to sham and control groups.
CONCLUSION


Dry needling has a positive effect on pain and disability reduction, cervical range of motion, and deep cervical flexor muscles performance in patients with cervicogenic headache and active trigger points, although the clinical relevance of the results was small.
TRIAL REGISTRATION


The trial design was registered in the Iranian Registry of Clinical Trials (www.irct.ir, IRCT20180721040539N1) before the first patient was enrolled.",2022,"Dry needling has a positive effect on pain and disability reduction, cervical range of motion and deep cervical flexor muscles performance in patients with cervicogenic headache and active trigger points, although the clinical relevance of the results was small.","['Sixty-five patients were finally included in the analysis', 'Physiotherapy Clinic, Rouhani Hospital of Babol University of Medical Sciences, Iran', 'Sixty-nine patients with cervicogenic headache', 'Cervicogenic Headache', 'Patients', 'patients with cervicogenic headache and active trigger points']","['adding real or sham dry needling with conventional physiotherapy', 'control group (n\u2009=\u200923) receiving conventional physical therapy; a dry needling group (n\u2009=\u200923) receiving conventional physical therapy and dry needling on the cervical muscles; placebo needling group (n\u2009=\u200923) receiving conventional physical therapy and superficial dry needling at a point away from the trigger point', 'Dry needling', 'Dry Needling to Physical Therapy']","['headache intensity and frequency', 'pain and disability reduction, cervical range of motion and deep cervical flexor muscles performance', 'Neck disability, deep cervical flexor performance and range of motion', 'Higher cervical range of motion and enhancement of deep cervical flexors performance', 'Headache intensity and neck disability', 'frequency of headaches']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0458101', 'cui_str': 'Cervicogenic headache'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}]","[{'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C2924612', 'cui_str': 'Cephalometric point A'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0857361', 'cui_str': 'Headache occurring'}]",69.0,0.0793335,"Dry needling has a positive effect on pain and disability reduction, cervical range of motion and deep cervical flexor muscles performance in patients with cervicogenic headache and active trigger points, although the clinical relevance of the results was small.","[{'ForeName': 'Seyedeh Roghayeh', 'Initials': 'SR', 'LastName': 'Mousavi-Khatir', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos (URJC), Alcorcón, Madrid, Spain.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Saadat', 'Affiliation': 'Department of Psychiatry, School of Medicine, Mobility Impairment Research Center, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Khodabakhsh', 'Initials': 'K', 'LastName': 'Javanshir', 'Affiliation': 'Mobility Impairment Research Center, Physiotherapy Department, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Zohrevand', 'Affiliation': 'Department of Surgery, School of Medicine, Babol University of Medical Sciences, Babol, Iran.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnab312']
1117,34678337,In vitro evaluation of marginal adaptation in medium- and large size direct class II restorations using a bulk-fill or layering technique.,"OBJECTIVES


to test if cavity dimensions and restorative protocol have potential to influence in-vitro adaptation of class II restoration after simulated thermo-occlusal stressing.
METHODS


A total of 32 prepared teeth were randomly assigned to one of the 4 experimental groups depending on cavity size, composite system and filling technique; group 1: small cavity and multi-layered conventional restorative composite (Tetric Evo-ceram: TEC), group 2: small cavity and flowable bulk-filled composite (SDRFlow: SDR) + one single occlusal layer of conventional restorative composite (TEC), group 3: large cavity and multilayered conventional restorative composite (TEC) and group 4: large cavity and bulk-filled flowable composite (SDR) + one single occlusal layer conventional restorative composite (TEC). All specimens were submitted to 500'000 cycles of thermomechanical loading (50 N, 5 to 55 °C). The proximal tooth-restoration interface was analyzed quantitatively by SEM, prior and after thermomechanical loading.
RESULTS


Before loading, continuous enamel adaptation varied from 61.49% (Gr 1) to 68.39% (Gr 4) proximally and from 50.93% (Gr2) to 68.65% (Gr1) cervically, with no statistical difference among groups for both segments. After thermomechanical loading, continuous enamel adaptation varied from 36.6% (Gr2) to 46.6% (Gr1) proximally, without significant difference, and from 20.2% (Gr4) to 51.3% (Gr1) cervically; statistical differences in cervical enamel adaptation were found in-between groups 1 and 2 (p = 0.0479), 1 and 4 (P = 0.0116), 2 and 3 (p = 0.0028) and 3 and 4 (p = 0.001). Before loading, dentin continuous adaptation varied from 55.32% (Gr3) to 81.82% (Gr4) with statistical difference in-between those groups (p = 0.045); after loading, dentin continuous adaptation varied from 31.56% (gr2) to 51% (Gr4) with a statistical difference between those 2 groups (p = 0.019). The drop in adaptations values after loading was significant in all groups and segments.
CONCLUSIONS


The impact of the restorative technique and cavity size on marginal adaptation appeared essentially after simulated fatigue for enamel adaptation. Cervical enamel and dentin continuous adaption of small and large bulk-filled restorations dropped significantly while the change was lower in layered restorations made of conventional restorative composite.
CLINICAL SIGNIFICANCE


Restorations made with bulk-filled flowable composite behaved differently from layered ones using conventional resin composite, according to cavity size and loading.",2021,"Cervical enamel and dentin continuous adaption of small and large bulk-filled restorations dropped significantly while the change was lower in layered restorations made of conventional restorative composite.
",['A total of 32 prepared teeth'],"['cavity size, composite system and filling technique; group 1: small cavity and multi-layered conventional restorative composite (Tetric Evo-ceram: TEC), group 2: small cavity and flowable bulk-filled composite (SDRFlow: SDR)\u202f+\u202fone single occlusal layer of conventional restorative composite (TEC), group 3: large cavity and multilayered conventional restorative composite (TEC) and group 4: large cavity and bulk-filled flowable composite (SDR)\u202f+\u202fone single occlusal layer conventional restorative composite (TEC', 'restorative technique and cavity size']","['Cervical enamel and dentin continuous adaption of small and large bulk-filled restorations', 'dentin continuous adaptation', 'continuous enamel adaptation', 'cervical enamel adaptation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4082130', 'cui_str': 'Prepared'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0292041', 'cui_str': 'Tetric'}, {'cui': 'C0229951', 'cui_str': 'Thymic epithelial cell'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0673997', 'cui_str': 'flowable hybrid composite'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]",32.0,0.103238,"Cervical enamel and dentin continuous adaption of small and large bulk-filled restorations dropped significantly while the change was lower in layered restorations made of conventional restorative composite.
","[{'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Dietschi', 'Affiliation': 'Department of Cariology, Endodontology & Pediatric Dentistry, School of Dentistry, University of Geneva, Geneva, Switzerland. Electronic address: didier.dietschi@unige.ch.'}, {'ForeName': 'Filipo Del', 'Initials': 'FD', 'LastName': 'Curto', 'Affiliation': 'Department of Cariology, Endodontology & Pediatric Dentistry, School of Dentistry, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Di Bella', 'Affiliation': 'Department of Political Sciences, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Krejci', 'Affiliation': 'Department of Cariology, Endodontology & Pediatric Dentistry, School of Dentistry, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ardu', 'Affiliation': 'Department of Cariology, Endodontology & Pediatric Dentistry, School of Dentistry, University of Geneva, Geneva, Switzerland.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103828']
1118,34687130,On-treatment gamma-glutamyl transferase predicts the development of hepatocellular carcinoma in chronic hepatitis B patients.,"BACKGROUND & AIMS


Gamma-glutamyl transferase (GGT) has been predictive of chronic hepatitis C-related hepatocellular carcinoma (HCC) development. Its role in the risk of HCC in chronic hepatitis B (CHB) patients treated with nucleotide/nucleoside analogues (NAs) is elusive.
METHODS


A total of 2172 CHB patients from East Asia were randomized into development and validation groups in a 1:2 ratio. Serum GGT levels before and 6 months (M6) after initiating NAs and the potential risk factors were measured. The primary endpoint was HCC development 12 months after NA initiation.
RESULTS


The annual incidence of HCC was 1.4/100 person-years in a follow-up period of 11 370.7 person-years. The strongest factor associated with HCC development was high M6-GGT levels (>25 U/L; hazard ratio [HR]/95% confidence interval [CI]: 3.31/2.02-5.42, P < .001), followed by cirrhosis (HR/CI: 2.06/1.39-3.06, P < .001), male sex (HR/CI: 2.01/1.29-3.13, P = .002) and age (HR/CI: 1.05/1.03-1.17, P < .001). Among cirrhotic patients, the incidence of HCC did not differ between those with high or low M6-GGT levels (P = .09). In contrast, among non-cirrhotic patients, the incidence of HCC was significantly higher for those with M6-GGT level >25 U/L than for their counterparts (P < .001). Cox regression analysis revealed that the strongest factor associated with HCC development in non-cirrhotic patients was high M6-GGT levels (HR/CI: 5.05/2.52-10.16, P < .001), followed by age (HR/CI: 1.07/1.04-1.09, P < .001). Non-cirrhotic elderly patients with high M6-GGT levels had a similarly high HCC risk as cirrhotic patients did (P = .29).
CONCLUSIONS


On-treatment serum GGT levels strongly predicted HCC development in CHB patients, particularly non-cirrhotic patients, treated with NAs.",2022,"Among cirrhotic patients, the incidence of HCC did not differ between those with high or low M6-GGT levels (P=0.09).","['2,172 CHB patients from East Asia', 'chronic hepatitis B patients']","['Gamma-glutamyl transferase (GGT', 'nucleotide/nucleoside analogues (NAs']","['incidence of HCC', 'annual incidence of HCC', 'M6-GGT levels', 'Serum GGT levels']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015631', 'cui_str': 'Far east country'}]","[{'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0028630', 'cui_str': 'Nucleotide'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside analog'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement'}, {'cui': 'C1278049', 'cui_str': 'Serum gamma-glutamyl transferase measurement'}]",2172.0,0.0404894,"Among cirrhotic patients, the incidence of HCC did not differ between those with high or low M6-GGT levels (P=0.09).","[{'ForeName': 'Chung-Feng', 'Initials': 'CF', 'LastName': 'Huang', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Tyng-Yuan', 'Initials': 'TY', 'LastName': 'Jang', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Dae Won', 'Initials': 'DW', 'LastName': 'Jun', 'Affiliation': 'Department of Internal Medicine, Hanyang University Hospital, Hanyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sang Bong', 'Initials': 'SB', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jihyun', 'Initials': 'J', 'LastName': 'An', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, South Korea.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Enomoto', 'Affiliation': 'Department of Hepatology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Liver Center, Saga University Hospital, Saga, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Ogawa', 'Affiliation': 'Department of General Internal Medicine, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Hanyang University Hospital, Hanyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Soung Won', 'Initials': 'SW', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae-Jun', 'Initials': 'JJ', 'LastName': 'Shim', 'Affiliation': 'Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae Yoon', 'Initials': 'JY', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, South Korea.'}, {'ForeName': 'Sung Eun', 'Initials': 'SE', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyan, South Korea.'}, {'ForeName': 'Hyunwoo', 'Initials': 'H', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Uijeongbu Eulji Medical Center, Eulji University School of Medicine, Uijeongbu, South Korea.'}, {'ForeName': 'Hyoung Su', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yong Kyun', 'Initials': 'YK', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ritsuzo', 'Initials': 'R', 'LastName': 'Kozuka', 'Affiliation': 'Department of Hepatology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Liver Center, Saga University Hospital, Saga, Japan.'}, {'ForeName': 'Ka Shing', 'Initials': 'KS', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Lung Yi', 'Initials': 'LY', 'LastName': 'Mak', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Jee-Fu', 'Initials': 'JF', 'LastName': 'Huang', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Chia-Yen', 'Initials': 'CY', 'LastName': 'Dai', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Man-Fung', 'Initials': 'MF', 'LastName': 'Yuen', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Mindie H', 'Initials': 'MH', 'LastName': 'Nguyen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University Medical Center, Palo Alto, California, USA.'}, {'ForeName': 'Ming-Lung', 'Initials': 'ML', 'LastName': 'Yu', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.15085']
1119,34688773,Postoperative Pain Relief Following Lumbar Erector Spinae Plane Block in Patients Undergoing Percutaneous Nephrolithotomy: A Randomized Controlled Trial.,"OBJECTIVE


To test whether lumbar Erector Spinae Plane Block (ESPB) provides superior analgesia compared to placebo in patients undergoing Percutaneous Nephrolithotomy (PCNL), using reduction in postoperative opioid consumption, delay in rescue analgesia demand and reduction of pain scores as outcome measures.
METHODS


34 adult (18-60 years) ASA I and II patients undergoing unilateral PCNL were randomized into two groups (Bupivacaine and Saline) - both receiving ipsilateral ESPB at L1 vertebral level with either 20 ml 0.25% Inj. Bupivacaine or 20 ml normal saline respectively, at the start of the surgery under general anesthesia. The primary outcome measure was total 24-hour rescue opioid analgesic requirement, while time to first demand of rescue analgesic and pain scores at 2, 12 and 24 hours postoperatively were secondary outcomes.
RESULTS


The 24-hour requirement of rescue analgesic Tramadol was significantly lower (53.5 ± 29.6 vs 121.2 ± 51.1 mg) [mean ± SD] (P = .001) and time to first demand of rescue analgesia was more (14.1 ± 8.4 vs 6.0 ± 5.6 hours) [mean ± SD] (P = .001) in the Bupivacaine group as compared to placebo. The pain scores were significantly lower in the Bupivacaine group at 12-hour post-operatively [4 (3,4) vs 5.5 (5,6)] [median (IQR)] (P = .001), while the stone-load, surgical duration and intraoperative opioid use were comparable between the two groups and no block-related complications were noted in any patient.
CONCLUSION


Post-PCNL, ipsilateral lumbar ESPB reduced 24-hour opioid consumption and delayed time to demand for rescue analgesia as compared to placebo.",2022,The 24-hour requirement of rescue analgesic Tramadol was significantly lower (53.5 ± 29.6 vs 121.2 ± 51.1 mg) [mean ± SD] (p = 0.001) and time to first demand of rescue analgesia was more (14.1 ± 8.4 vs 6.0 ± 5.6 hours) [mean ± SD] (p = 0.001) in the Bupivacaine group as compared to placebo.,"['patients undergoing Percutaneous Nephrolithotomy (PCNL', '34 adult (18-60 years) ASA I and II patients undergoing unilateral PCNL', 'patients undergoing Percutaneous Nephrolithotomy']","['Bupivacaine', 'Bupivacaine and Saline) - both receiving ipsilateral ESPB', 'lumbar Erector Spinae Plane Block (ESPB', 'lumbar Erector Spinae Plane Block', 'placebo']","['Postoperative pain relief', 'time to first demand of rescue analgesia', '24-hour opioid consumption and delayed time to demand for rescue analgesia', 'total 24-hour rescue opioid analgesic requirement, while time to first demand of rescue analgesic and pain scores', 'pain scores', 'stone-load, surgical duration and intraoperative opioid use', '24-hour requirement of rescue analgesic Tramadol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]",34.0,0.704769,The 24-hour requirement of rescue analgesic Tramadol was significantly lower (53.5 ± 29.6 vs 121.2 ± 51.1 mg) [mean ± SD] (p = 0.001) and time to first demand of rescue analgesia was more (14.1 ± 8.4 vs 6.0 ± 5.6 hours) [mean ± SD] (p = 0.001) in the Bupivacaine group as compared to placebo.,"[{'ForeName': 'Satyaki', 'Initials': 'S', 'LastName': 'Sarkar', 'Affiliation': 'Department of Anesthesiology & Critical Care, AIIMS, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Sritam Swarup', 'Initials': 'SS', 'LastName': 'Jena', 'Affiliation': 'Department of Anesthesiology & Critical Care, AIIMS, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Prasant', 'Initials': 'P', 'LastName': 'Nayak', 'Affiliation': 'Department of Urology, AIIMS, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Jayanta Kumar', 'Initials': 'JK', 'LastName': 'Mitra', 'Affiliation': 'Department of Anesthesiology & Critical Care, AIIMS, Bhubaneswar, Odisha, India. Electronic address: mitra.jayanta@gmail.com.'}]",Urology,['10.1016/j.urology.2021.10.006']
1120,34690144,Using Biomarkers to Predict Memantine Effects in Alzheimer's Disease: A Proposal and Proof-Of-Concept Demonstration.,"Memantine's benefits in Alzheimer's disease (AD) are modest and heterogeneous. We tested the feasibility of using sensitivity to acute memantine challenge to predict an individual's clinical response. Eight participants completed a double-blind challenge study of memantine (placebo versus 20 mg) effects on autonomic, subjective, cognitive, and neurophysiological measures, followed by a 24-week unblinded active-dose therapeutic trial (10 mg bid). Study participation was well tolerated. Subgroups based on memantine sensitivity on specific laboratory measures differed in their clinical response to memantine, some by large effect sizes. It appears feasible to use biomarkers to predict clinical sensitivity to memantine.",2021,"Eight participants completed a double-blind challenge study of memantine (placebo versus 20 mg) effects on autonomic, subjective, cognitive, and neurophysiological measures, followed by a 24-week unblinded active-dose therapeutic trial (10 mg bid).","[""Alzheimer's Disease"", ""Alzheimer's disease (AD""]","['memantine (placebo', 'Memantine']","['autonomic, subjective, cognitive, and neurophysiological measures', 'tolerated']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.298985,"Eight participants completed a double-blind challenge study of memantine (placebo versus 20 mg) effects on autonomic, subjective, cognitive, and neurophysiological measures, followed by a 24-week unblinded active-dose therapeutic trial (10 mg bid).","[{'ForeName': 'Neal R', 'Initials': 'NR', 'LastName': 'Swerdlow', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Juliana E', 'Initials': 'JE', 'LastName': 'Kotz', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Yash B', 'Initials': 'YB', 'LastName': 'Joshi', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Talledo', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Sprock', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Juan L', 'Initials': 'JL', 'LastName': 'Molina', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Branko', 'Initials': 'B', 'LastName': 'Huisa', 'Affiliation': 'Department of Neurosciences, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Steven F', 'Initials': 'SF', 'LastName': 'Huege', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Jairo Alberto', 'Initials': 'JA', 'LastName': 'Romero', 'Affiliation': 'Department of Medicine, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Delano-Wood', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Light', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-215029']
1121,34686614,Effect of Moderate- or High-Intensity Inspiratory Muscle Strength Training on Maximal Inspiratory Mouth Pressure and Swimming Performance in Highly Trained Competitive Swimmers.,"PURPOSE


Inspiratory muscle strength training (IMST) can improve exercise performance. Increased maximal inspiratory mouth pressure (MIP) could be beneficial for swimmers to enhance their performance. This study aimed to clarify the effect of high-intensity IMST for 6 weeks on MIP and swimming performance in highly trained competitive swimmers.
METHODS


Thirty male highly trained competitive swimmers were assigned to high-intensity IMST (HI; n = 10), moderate-intensity IMST (MOD; n = 10), and control (n = 10) groups. The 6-week IMST intervention comprised twice daily sessions for 6 d/wk at inspiratory pressure threshold loads equivalent to 75% MIP (HI) and 50% MIP (MOD). Before and after the intervention, MIP and swimming performance were assessed. Swimming performance was evaluated in free and controlled frequency breathing 100-m freestyle swimming time trials in a 25-m pool. For controlled frequency breathing, participants took 1 breath every 6 strokes.
RESULTS


The MIP values after 2 and 6 weeks of IMST in the HI and MOD groups were significantly higher than those before IMST (P = .0001). The magnitudes of the MIP increases after 6 weeks of IMST did not differ between the HI (13.4% [8.7%]) and MOD (13.1% [10.1%]) groups (P = .44). The 100-m freestyle swimming times under the controlled frequency condition were significantly shorter after IMST than those before IMST in both the HI (P = .046) and MOD (P = .042) groups.
CONCLUSIONS


Inspiratory pressure threshold load equivalent to 50% MIP could be sufficient to improve MIP and swimming performance under the controlled frequency breathing condition in highly trained competitive swimmers.",2021,The MIP values after 2 and 6 weeks of IMST in the HI and MOD groups were significantly higher than those before IMST (P = .0001).,"['Highly Trained Competitive Swimmers', 'highly trained competitive swimmers', 'Thirty male highly trained competitive swimmers']","['Inspiratory muscle strength training (IMST', 'IMST intervention', 'high-intensity IMST', 'moderate-intensity IMST', 'Moderate- or High-Intensity Inspiratory Muscle Strength Training', 'IMST']","['100-m freestyle swimming times under the controlled frequency condition', 'MOD', 'exercise performance', 'MIP values', 'maximal inspiratory mouth pressure (MIP', 'Maximal Inspiratory Mouth Pressure and Swimming Performance', 'MIP and swimming performance']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",30.0,0.0597911,The MIP values after 2 and 6 weeks of IMST in the HI and MOD groups were significantly higher than those before IMST (P = .0001).,"[{'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Ohya', 'Affiliation': ''}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Kusanagi', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Koizumi', 'Affiliation': ''}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Ando', 'Affiliation': ''}, {'ForeName': 'Keisho', 'Initials': 'K', 'LastName': 'Katayama', 'Affiliation': ''}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2021-0119']
1122,34688506,Translating Violence Prevention Programs from Research to Practice: SafERteens Implementation in an Urban Emergency Department.,"BACKGROUND


Youth violence is a leading cause of adolescent mortality, underscoring the need to integrate evidence-based violence prevention programs into routine emergency department (ED) care.
OBJECTIVES


To examine the translation of the SafERteens program into clinical care.
METHODS


Hospital staff provided input on implementation facilitators/barriers to inform toolkit development. Implementation was piloted in a four-arm effectiveness-implementation trial, with youth (ages 14-18 years) screening positive for past 3-month aggression randomized to either SafERteens (delivered remotely or in-person) or enhanced usual care (EUC; remote or in-person), with follow-up at post-test and 3 months. During maintenance, ED staff continued in-person SafERteens delivery and external facilitation was provided. Outcomes were measured using the RE-AIM implementation framework.
RESULTS


SafERteens completion rates were 77.6% (52/67) for remote and 49.1% (27/55) for in-person delivery. In addition to high acceptability ratings (e.g., helpfulness), post-test data demonstrated increased self-efficacy to avoid fighting among patients receiving remote (incidence rate ratio [IRR] 1.22, 95% confidence interval [CI] 1.09-1.36) and in-person (IRR 1.23, 95% CI 1.12-1.36) SafERteens, as well as decreased pro-violence attitudes among patients receiving remote (IRR 0.83, 95% CI 0.75-0.91) and in-person (IRR 0.87, 95% CI 0.77-0.99) SafERteens when compared with their respective EUC groups. At 3 months, youth receiving remote SafERteens reported less non-partner aggression (IRR 0.52, 95% CI 0.31-0.87, Cohen's d -0.39) and violence consequences (IRR 0.47, 95% CI 0.22-1.00, Cohen's d -0.49) compared with remote EUC; no differences were noted for in-person SafERteens delivery. Barriers to implementation maintenance included limited staff availability and a lack of reimbursement codes.
CONCLUSIONS


Implementing behavioral interventions such as SafERteens into routine ED care is feasible using remote delivery. Policymakers should consider reimbursement for violence prevention services to sustain long-term implementation.",2022,"At 3 months, youth receiving remote SafERteens reported less non-partner aggression (IRR 0.52, 95% CI 0.31-0.87, Cohen's d -0.39) and violence consequences (IRR 0.47, 95% CI 0.22-1.00, Cohen's d -0.49) compared with remote EUC; no differences were noted for in-person SafERteens delivery.","['Urban Emergency Department', 'youth (ages 14-18 years) screening positive for past 3-month aggression randomized to either']",['SafERteens (delivered remotely or in-person) or enhanced usual care (EUC; remote or in-person'],"['self-efficacy', 'pro-violence attitudes', 'non-partner aggression', 'violence consequences']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205157', 'cui_str': 'Remote'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}]",,0.168677,"At 3 months, youth receiving remote SafERteens reported less non-partner aggression (IRR 0.52, 95% CI 0.31-0.87, Cohen's d -0.39) and violence consequences (IRR 0.47, 95% CI 0.22-1.00, Cohen's d -0.49) compared with remote EUC; no differences were noted for in-person SafERteens delivery.","[{'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Carter', 'Affiliation': 'University of Michigan Injury Prevention Center, Ann Arbor, Michigan; Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan; Youth Violence Prevention Center; Department of Health Behavior/Health Education, University of Michigan School of Public Health, Ann Arbor, Michigan.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Cunningham', 'Affiliation': 'University of Michigan Injury Prevention Center, Ann Arbor, Michigan; Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan; Youth Violence Prevention Center; Department of Health Behavior/Health Education, University of Michigan School of Public Health, Ann Arbor, Michigan; Department of Emergency Medicine, Hurley Medical Center, Flint, Michigan.'}, {'ForeName': 'Andria B', 'Initials': 'AB', 'LastName': 'Eisman', 'Affiliation': 'Youth Violence Prevention Center; Department of Health Behavior/Health Education, University of Michigan School of Public Health, Ann Arbor, Michigan; Division of Kinesiology, Health and Sport Studies, College of Education, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior/Health Education, University of Michigan School of Public Health, Ann Arbor, Michigan.'}, {'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Roche', 'Affiliation': 'University of Michigan Injury Prevention Center, Ann Arbor, Michigan; Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Jennifer Tang', 'Initials': 'JT', 'LastName': 'Cole', 'Affiliation': 'University of Michigan Injury Prevention Center, Ann Arbor, Michigan; Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Goldstick', 'Affiliation': 'University of Michigan Injury Prevention Center, Ann Arbor, Michigan; Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Kilbourne', 'Affiliation': 'Health Services Research and Development Service, Veterans Health Administration, U.S. Department of Veterans Affairs, Washington, DC; Department of Learning Health Sciences.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'University of Michigan Injury Prevention Center, Ann Arbor, Michigan; Addiction Center, Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2021.09.003']
1123,34686472,"SWOG 1918: A phase II/III randomized study of R-miniCHOP with or without oral azacitidine (CC-486) in participants age 75 years or older with newly diagnosed aggressive non-Hodgkin lymphomas - Aiming to improve therapy, outcomes, and validate a prospective frailty tool.","Diffuse large B cell lymphoma (DLBCL) is an aggressive but potentially curable malignancy; however, cure is highly dependent on the ability to deliver intensive, anthracycline-based chemoimmunotherapy. Nearly one third of cases of DLBCL occur in patients over age 75 years, and advanced age is an important adverse feature in prognostic models. Despite this incidence in older patients, there is no clear accepted standard of care due to under-representation of this group in large randomized clinical trials. Furthermore, insufficient assessments of baseline frailty and prediction of toxicity hamper clinical decision-making. Here, we present an ongoing randomized study of R-miniCHOP chemoimmunotherapy with or without oral azacitidine (CC-486, Onureg) for patients age 75 and older with newly diagnosed DLBCL and associated aggressive lymphomas. The incorporation of an oral hypomethylating agent is based on increased tumor methylation as a biologic feature of older patients with DLBCL and a desire to minimize the injection burden for this population. This is the first randomized study in this population conducted in North America by the National Clinical Trials Network (NCTN) and will enroll up to 422 patients including 40 patients in a safety run-in phase. This study incorporates an objective assessment of baseline frailty (the FIL Tool) and a serial comprehensive geriatric assessment (CGA). Key correlative tests will include circulating tumor DNA (ctDNA) assays at pre-specified timepoints to explore if ctDNA quantity and methylation patterns correlate with response. S1918 has the potential to impact future trial design and to change the standard of care for patients 75 years and older with aggressive lymphoma given its randomized design, prospective incorporation of geriatric assessments, and exploration of ctDNA correlatives. Trial registration: The trial is registered with ClinicalTrial.gov Identifier NCT04799275.",2022,"S1918 has the potential to impact future trial design and to change the standard of care for patients 75 years and older with aggressive lymphoma given its randomized design, prospective incorporation of geriatric assessments, and exploration of ctDNA correlatives.","['older patients', 'SWOG 1918', 'older patients with DLBCL', 'patients 75\xa0years and older with aggressive lymphoma', 'participants age 75\xa0years or older with newly diagnosed aggressive non-Hodgkin lymphomas', 'Diffuse large B cell lymphoma (DLBCL', '422 patients including 40 patients in a safety run-in phase', 'patients age 75 and older with newly diagnosed DLBCL and associated aggressive lymphomas']","['serial comprehensive geriatric assessment (CGA', 'R-miniCHOP chemoimmunotherapy with or without oral azacitidine (CC-486, Onureg', 'R-miniCHOP with or without oral azacitidine (CC-486']",[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}]",[],422.0,0.0652391,"S1918 has the potential to impact future trial design and to change the standard of care for patients 75 years and older with aggressive lymphoma given its randomized design, prospective incorporation of geriatric assessments, and exploration of ctDNA correlatives.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Brem', 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, CA, USA. Electronic address: ebrem@hs.uci.edu.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, WA, USA; Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Anne W', 'Initials': 'AW', 'LastName': 'Beaven', 'Affiliation': 'Lineberger Comprehensive Cancer Center University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Paolo F', 'Initials': 'PF', 'LastName': 'Caimi', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Cerchietti', 'Affiliation': 'Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Ash A', 'Initials': 'AA', 'LastName': 'Alizadeh', 'Affiliation': 'Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Olin', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'N Lynn', 'Initials': 'NL', 'LastName': 'Henry', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Hildy', 'Initials': 'H', 'LastName': 'Dillon', 'Affiliation': 'Patient Advocate, Teaneck, NJ, USA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Little', 'Affiliation': 'National Cancer Institute, Cancer Therapy Evaluation Program (CTEP), Bethesda, MD, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Laubach', 'Affiliation': 'SWOG Operations Office, San Antonio, TX, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'LeBlanc', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, WA, USA; Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': 'University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Sonali M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2021.10.003']
1124,34686445,Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study.,"INTRODUCTION


This double-blind, parallel-group, active-controlled phase III trial (NCT02260804) assessed CT-P10 and rituximab safety and efficacy in patients with previously untreated low-tumor-burden follicular lymphoma (LTBFL), including after a single switch from rituximab to CT-P10.
PATIENTS AND METHODS


LTBFL patients were randomized (1:1) to receive CT-P10 or rituximab (375 mg/m 2  intravenously; day 1 of 4 7-day cycles). Patients achieving disease control entered a 2-year maintenance period. CT-P10 or rituximab were administered every 8 weeks (6 cycles) in year 1; all patients could receive CT-P10 (every 8 weeks; 6 cycles) in year 2. Secondary endpoints (reported here) were overall response rate (ORR) during the study period, progression-free survival (PFS), time to progression (TTP), and overall survival (OS). Safety and immunogenicity were evaluated.
RESULTS


Between  November 9, 2015 and  January 4, 2018, 258 patients were randomized (130 for CT-P10; 128 for rituximab). ORR was similar between groups over the study period (CT-P10: 88%; rituximab: 87%). After 29.2 months' median follow-up, median PFS, TTP, and OS were not estimable; 24-month Kaplan-Meier estimates suggested similarity between groups. Overall, 114 (CT-P10: 88%), and 104 (rituximab: 81%) patients experienced treatment-emergent adverse events. The single switch was well tolerated.
CONCLUSION


These updated data support therapeutic similarity of CT-P10 and rituximab and support the use of CT-P10 monotherapy for previously untreated LTBFL.",2022,ORR was similar between groups over the study period (CT-P10: 88%; rituximab: 87%).,"['patients with previously untreated low-tumor-burden follicular lymphoma (LTBFL), including after a single switch from rituximab to CT-P10', '258 patients', 'Untreated Low-Tumor-Burden Follicular Lymphoma', 'LTBFL patients', 'Between\xa0 November 9, 2015 and\xa0 January 4, 2018']","['CT-P10 Versus Rituximab', 'CT-P10 or rituximab']","['tolerated', 'Efficacy and Safety', 'Safety and immunogenicity', 'ORR', 'median PFS, TTP, and OS', 'CT-P10 and rituximab safety and efficacy', 'treatment-emergent adverse events', 'overall response rate (ORR) during the study period, progression-free survival (PFS), time to progression (TTP), and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4287770', 'cui_str': 'CT-P10'}]","[{'cui': 'C4287770', 'cui_str': 'CT-P10'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0034155', 'cui_str': 'Thrombotic thrombocytopenic purpura'}, {'cui': 'C4287770', 'cui_str': 'CT-P10'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",258.0,0.0923978,ORR was similar between groups over the study period (CT-P10: 88%; rituximab: 87%).,"[{'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Kwak', 'Affiliation': 'Comprehensive Cancer Center, Duarte, CA 91010.'}, {'ForeName': 'Juan-Manuel', 'Initials': 'JM', 'LastName': 'Sancho', 'Affiliation': 'Hematology Department, The Catalan Institute of Oncology-The Josep Carreras Leukemia Research Institute, Hospital Germans Trias i Pujol, Carretera Canyet, Badalona, 08916, Spain.'}, {'ForeName': 'Seok-Goo', 'Initials': 'SG', 'LastName': 'Cho', 'Affiliation': ""Department of Hematology, Catholic Blood and Marrow Transplantation Center, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, 06591, South Korea.""}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Nakazawa', 'Affiliation': 'Department of Hematology, Shinshu University School of Medicine, Nagano 390-8621, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Suzumiya', 'Affiliation': 'Shimane University Hospital, Innovative Cancer Center/Oncology-Hematology, Izumo, Shimane 693-8501, Japan.'}, {'ForeName': 'Gayane', 'Initials': 'G', 'LastName': 'Tumyan', 'Affiliation': 'Division of Hematology and Bone Marrow Transplantation, N. N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Science, Moscow, 115478, Russia.'}, {'ForeName': 'Jin Seok', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, 03722, South Korea.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Menne', 'Affiliation': 'Northern Institute for Cancer Care, Newcastle University, NE7 7DN, UK.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Mariz', 'Affiliation': 'Department of Onco-Hematology, Portuguese Institute of Oncology, Rua Dr Antonio Bernardino de Almeida, Porto, 4200-072, Portugal.'}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Ilyin', 'Affiliation': 'Russian Research Center for Radiology and Surgical Technologies, Ministry of Health of the Russian Federation, p. Pesochny, 197758, Russia.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Jurczak', 'Affiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology, 331-115 Kraków, Poland.'}, {'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'Lopez Martinez', 'Affiliation': 'Department of Hematology, Hospital Arnau de Vilanova, Valencia, Comunidad Valenciana, 46015, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Samoilova', 'Affiliation': 'Department of Hematology, Nizhniy Novgorod Region Clinical Hospital, Nizhniy Novgorod, 603126, Russia.'}, {'ForeName': 'Edvard', 'Initials': 'E', 'LastName': 'Zhavrid', 'Affiliation': 'N. N. Alexandrov Republican Scientific and Practical Centre of Oncology and Medical Radiology, Lesnoy, Minsk, 223040, Belarus.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Yañez Ruiz', 'Affiliation': 'Department of Internal Medicine, Oncology-Hematology Unit, School of Medicine, Universidad de la Frontera, Temuco, 4780000, Chile.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Trneny', 'Affiliation': 'Department of Medicine, Charles University, 128 08, Czech Republic.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Popplewell', 'Affiliation': 'Toni Stephenson Lymphoma Cancer Center and Department of Hematology and Hematopoietic Cell Transplantation, Duarte, CA 91010.'}, {'ForeName': 'Michinori', 'Initials': 'M', 'LastName': 'Ogura', 'Affiliation': 'Department of Hematology and Oncology, Kasugai Municipal Hospital, Aichi 486-8510, Japan.'}, {'ForeName': 'Won-Seog', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06355, South Korea.'}, {'ForeName': 'Sang Joon', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Celltrion, Inc, Incheon, 22014, South Korea.'}, {'ForeName': 'Sung Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Celltrion, Inc, Incheon, 22014, South Korea.'}, {'ForeName': 'Keum Young', 'Initials': 'KY', 'LastName': 'Ahn', 'Affiliation': 'Celltrion, Inc, Incheon, 22014, South Korea.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Buske', 'Affiliation': 'Institute of Experimental Cancer Research, Comprehensive Cancer Center Ulm, University Hospital of Ulm, 89081 Ulm, Germany. Electronic address: christian.buske@uni-ulm.de.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2021.08.005']
1125,34689288,Comparison of combination therapy of prednisolone and cyclosporine with corticosteroid pulse therapy in Vogt-Koyanagi-Harada disease.,"PURPOSE


To compare the efficacy and safety of a combination therapy of prednisolone and cyclosporine and corticosteroid pulse therapy in Vogt-Koyanagi-Harada (VKH) disease.
STUDY DESIGN


A prospective, multicenter, randomized, non-inferiority trial.
METHODS


Patients of new-onset acute VKH disease at 11 centers in Japan between 2014 and 2018 were randomized to a combination (oral prednisolone 60 mg daily with gradual taper-off to 35 mg/day and cyclosporine 3 mg/kg/day) and corticosteroid (methylprednisolone 1000 mg for 3 days followed by oral prednisolone) groups, and were followed for 1 year.
RESULTS


Thirty-four were assigned to the combination and thirty-six patients to the corticosteroid group. Recurrence/worsening risk was 0.15 (95% confidence-interval [CI] 0.03-0.27) in the combination group and 0.25 (95% CI 0.11-0.39) in the corticosteroid group, with a risk difference of - 0.10 (90% CI - 0.27 to 0.06), demonstrating non-inferiority of the combination group with a non-inferiority margin of 0.20 (P = 0.0013). Serious adverse events occurred in three patients (two with hyponatremia and one with severe headaches) in the combination group and none in the corticosteroid group. Sunset glow fundus grades and cataract rates at 1 year were 0.57 (95% CI 0.42-71) and 4.3% in the combination group and 0.91 (95% CI 0.78-1.04) and 34.0% in the corticosteroid group, respectively.
CONCLUSIONS


Combination therapy was noninferior to corticosteroid therapy with respect to recurrence/worsening risk. Notably, the recurrence/worsening risk, sunset glow fundus grade, and cataract rate were lower in the combination group than in the corticosteroid group.",2022,Serious adverse events occurred in three patients (two with hyponatremia and one with severe headaches) in the combination group and none in the corticosteroid group.,"['Patients of new-onset acute VKH disease at 11 centers in Japan between 2014 and 2018', 'Thirty-four were assigned to the combination and thirty-six patients to the corticosteroid group', 'Vogt-Koyanagi-Harada disease']","['prednisolone and cyclosporine with corticosteroid pulse therapy', 'combination (oral prednisolone 60\xa0mg daily with gradual taper-off to 35\xa0mg/day and cyclosporine 3\xa0mg/kg/day) and corticosteroid (methylprednisolone 1000\xa0mg for 3\xa0days followed by oral prednisolone', 'prednisolone and cyclosporine and corticosteroid pulse therapy']","['Serious adverse events', 'Recurrence/worsening risk', 'recurrence/worsening risk, sunset glow fundus grade, and cataract rate', 'efficacy and safety', 'severe headaches', 'cataract rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1276802', 'cui_str': 'Sudden'}, {'cui': 'C0042170', 'cui_str': 'Vogt-Koyanagi-Harada disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C4084446', 'cui_str': 'Methylprednisolone 1000 MG'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4748924', 'cui_str': 'Global developmental delay, lung cysts, overgrowth, Wilms tumor syndrome'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",,0.125219,Serious adverse events occurred in three patients (two with hyponatremia and one with severe headaches) in the combination group and none in the corticosteroid group.,"[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ono', 'Affiliation': 'Miyata Eye Hospital, 6-3 Kurahara, Miyakonojo, Miyazaki, 885-0051, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Goto', 'Affiliation': 'Department of Ophthalmology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Department of Ophthalmology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Fumihiko', 'Initials': 'F', 'LastName': 'Nitta', 'Affiliation': 'Department of Ophthalmology and Visual Science, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Mizuki', 'Affiliation': 'Department of Ophthalmology, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takase', 'Affiliation': 'Department of Ophthalmology and Visual Science, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kaneko', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Yamagata University Faculty of Medicine, Yamagata, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Hori', 'Affiliation': 'Department of Ophthalmology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Department of Ophthalmology, Oita University, Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Nao-I', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Ohguro', 'Affiliation': 'Department of Ophthalmology, Japan Community Healthcare Organization Osaka Hospital, Osaka, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Miyata', 'Affiliation': 'Miyata Eye Hospital, 6-3 Kurahara, Miyakonojo, Miyazaki, 885-0051, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tomita', 'Affiliation': 'School of Data Science, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Mochizuki', 'Affiliation': 'Miyata Eye Hospital, 6-3 Kurahara, Miyakonojo, Miyazaki, 885-0051, Japan. m.manabu.oph@tmd.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Japanese journal of ophthalmology,['10.1007/s10384-021-00878-w']
1126,34690334,The Effect of Bergamot Essential Oil Aromatherapy on Improving Depressive Mood and Sleep Quality in Postpartum Women: A Randomized Controlled Trial.,"BACKGROUND


The postpartum period is a physiologically and psychologically crucial transition phase for every woman who gives birth. Aromatherapy may improve mood and alleviate sleep challenges. However, few randomized controlled clinical trials have focused on the effect of aromatherapy in postpartum women.
PURPOSE


This study was designed to explore the effect of a bergamot essential oil aromatherapy intervention on depressive mood and sleep quality in postpartum women.
METHODS


This randomized controlled trial used consecutive sampling. The participants were all women in a postpartum care center in eastern Taiwan and were randomly assigned to either the experimental (n = 29) or control (n = 31) group. Bergamot essential oil aroma was used in the experimental group, and pure water aroma was used in the control group. The experimental and control interventions were both performed while the participants were residents at the postpartum care center in the afternoon for 15 minutes each day. Before the aroma intervention, pretests were conducted using the Edinburgh Postnatal Depression Scale and the Postpartum Sleep Quality Scale. The first and second posttests were conducted using the same two scales at 2 and 4 weeks after the intervention, respectively.
RESULTS


At both the first and second posttests, depressive mood was significantly lower (p < .001) in the experimental group than in the control group, supporting the positive effect of the bergamot essential oil aroma intervention on depressive mood in postpartum women. No significant intergroup difference in sleep quality (p > .05) was observed at either the first or second posttest, indicating an uncertain effect of the bergamot essential oil aroma intervention on sleep quality.
CONCLUSIONS/IMPLICATIONS FOR PRACTICE


The results of this study support the effectiveness of bergamot essential oil aromatherapy in alleviating depressive mood in postpartum women. In addition, the results provide a practical reference for clinical postpartum nursing care.",2022,"No significant intergroup difference in sleep quality (p > .05) was observed at either the first or second posttest, indicating an uncertain effect of the bergamot essential oil aroma intervention on sleep quality.
","['participants were all women in a postpartum care center in eastern Taiwan', 'postpartum women', 'Postpartum Women']","['aromatherapy', 'Aromatherapy', 'bergamot essential oil aromatherapy intervention', 'Bergamot Essential Oil Aromatherapy', 'bergamot essential oil aromatherapy', 'bergamot essential oil aroma intervention']","['Depressive Mood and Sleep Quality', 'depressive mood', 'depressive mood and sleep quality', 'mood and alleviate sleep challenges', 'sleep quality', 'Edinburgh Postnatal Depression Scale and the Postpartum Sleep Quality Scale']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}]","[{'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C3715207', 'cui_str': 'Bergamot orange extract'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2987717', 'cui_str': 'Scents'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0869185,"No significant intergroup difference in sleep quality (p > .05) was observed at either the first or second posttest, indicating an uncertain effect of the bergamot essential oil aroma intervention on sleep quality.
","[{'ForeName': 'Mei-Ling', 'Initials': 'ML', 'LastName': 'Chen', 'Affiliation': 'Doctoral Candidate, RN, School of Nursing, National Taiwan University, Taipei, Taiwan, ROC MSN, RN, Lecturer, Department of Nursing, Tzu Chi University of Science and Technology, Hualien, Taiwan, ROC MSN, RN, Commissioner, Department of Medical Affairs, Mennonite Christian Hospital, Hualien, Taiwan, ROC.'}, {'ForeName': 'Yueh-Er', 'Initials': 'YE', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Hui-Fang', 'Initials': 'HF', 'LastName': 'Lee', 'Affiliation': ''}]",The journal of nursing research : JNR,['10.1097/jnr.0000000000000459']
1127,34694179,Human papillomavirus self-sampling for long-term non-attenders in cervical cancer screening: A randomised feasibility study in Estonia.,"OBJECTIVE


Organised cervical cancer screening was started in Estonia in 2006, but participation is still low. Human papillomavirus (HPV) self-sampling has proved to increase screening uptake. This study addressed the feasibility of HPV self-sampling and the acceptance of this method among long-term screening non-attenders.
METHODS


A randomised intervention study was conducted in Estonia in 2020. Women born in 1958-1983 without a Pap smear in 2013-2019 were identified in the Estonian Health Insurance Fund database. From them, 12,000 women were randomly allocated to three equal-sized study groups. The opt-out group received a questionnaire and a Qvintip® sampling device by regular mail. Two opt-in groups received a questionnaire and an e-mail invitation to order a self-sampler online; one received Qvintip and the other Evalyn® Brush. Participantś background characteristics were obtained from the Population Register. The effect of covariates on participation rate was estimated with multivariate Poisson regression. Acceptance of self-sampling was analysed according to agreement with statements in the questionnaire.
RESULTS


The overall participation rate was 16% with significant differences between opt-out (26%) and opt-in (11%) groups. Compared to the opt-out Qvintip group, adjusted relative risks for the Qvintip and Evalyn Brush opt-in groups were 0.41 (95% confidence interval (CI) 0.37-0.45) and 0.44 (95% CI 0.40-0.49), respectively. Participation was associated with living place, citizenship, and education. Self-sampling was well accepted: 98% agreed that it was easy to use, 88% preferred it as a screening method in future.
CONCLUSIONS


The results show the feasibility and good acceptance of HPV self-sampling among long-term screening non-attenders in Estonia.",2022,"Compared to the opt-out Qvintip group, adjusted relative risks for the Qvintip and Evalyn Brush opt-in groups were 0.41 (95% confidence interval (CI) 0.37-0.45) and 0.44 (95% CI 0.40-0.49), respectively.","['Estonia in 2020', 'cervical cancer screening', '12,000 women', 'Women born in 1958-1983 without a Pap smear in 2013-2019 were identified in the Estonian Health Insurance Fund database']","['questionnaire and a Qvintip® sampling device by regular mail', 'questionnaire and an e-mail invitation to order a self-sampler online; one received Qvintip and the other Evalyn® Brush', 'HPV self-sampling']","['participation rate', 'overall participation rate', 'feasibility and good acceptance of HPV self-sampling']","[{'cui': 'C0014908', 'cui_str': 'Estonia'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0456587', 'cui_str': '1958'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0014909', 'cui_str': 'Estonian language'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0335511', 'cui_str': 'Sampler (mine)'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",12000.0,0.0426419,"Compared to the opt-out Qvintip group, adjusted relative risks for the Qvintip and Evalyn Brush opt-in groups were 0.41 (95% confidence interval (CI) 0.37-0.45) and 0.44 (95% CI 0.40-0.49), respectively.","[{'ForeName': 'Piret', 'Initials': 'P', 'LastName': 'Veerus', 'Affiliation': 'Department of Epidemiology and Biostatistics, 241808National Institute for Health Development, Tallinn, Estonia.'}, {'ForeName': 'Reeli', 'Initials': 'R', 'LastName': 'Hallik', 'Affiliation': 'Department of Epidemiology and Biostatistics, 241808National Institute for Health Development, Tallinn, Estonia.'}, {'ForeName': 'Jaak', 'Initials': 'J', 'LastName': 'Jänes', 'Affiliation': 'Department of Epidemiology and Biostatistics, 241808National Institute for Health Development, Tallinn, Estonia.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Jõers', 'Affiliation': '37544Tartu University Hospital United Laboratories, Tartu, Estonia.'}, {'ForeName': 'Keiu', 'Initials': 'K', 'LastName': 'Paapsi', 'Affiliation': 'Department of Epidemiology and Biostatistics, 241808National Institute for Health Development, Tallinn, Estonia.'}, {'ForeName': 'Kaia', 'Initials': 'K', 'LastName': 'Laidra', 'Affiliation': 'Department of Epidemiology and Biostatistics, 241808National Institute for Health Development, Tallinn, Estonia.'}, {'ForeName': 'Kaire', 'Initials': 'K', 'LastName': 'Innos', 'Affiliation': 'Department of Epidemiology and Biostatistics, 241808National Institute for Health Development, Tallinn, Estonia.'}]",Journal of medical screening,['10.1177/09691413211052499']
1128,34694154,Supine versus Prone Percutaneous Nephrolithotomy for Complex Stones: A Multicenter Randomized Controlled Trial.,"PURPOSE


High-quality evidence comparing supine to prone percutaneous nephrolithotomy (PCNL) for the treatment of complex stones is lacking. This study aimed to compare the outcomes of supine position (SUP) and prone position (PRO) PCNL.
MATERIALS AND METHODS


A noninferior randomized controlled trial was performed according to the CONSORT (Consolidated Standards for Reporting Trials) criteria. The inclusion criteria were patients over 18 years of age with complex stones. SUP was performed in the Barts flank-free modified position. Except for positioning, all the surgical parameters were identical. The primary outcome was the difference in the success rate on the first postoperative day (POD1) between groups. The secondary outcome was the difference in the stone-free rate (SFR) on the 90th postoperative day (final SFR). A noninferiority margin of 15% was used. Demographic, operative, and safety variables were compared between the groups. Statistical significance was set at p <0.05.
RESULTS


Overall, 112 patients were randomized and their demographic characteristics were comparable. The success rates on POD1 were similar (SUP: 62.5% vs PRO: 57.1%, p=0.563). The difference observed (-5.4%) was lower than the predefined limit. The final SFRs were also similar (SUP: 55.4% vs PRO: 50.0%, p=0.571). SUP had a shorter operative time (mean±SD 117.9±39.1 minutes vs 147.6±38.8 minutes, p <0.001) and PRO had a higher rate of Clavien ≥3 complications (14.3% vs 3.6%, p=0.045).
CONCLUSIONS


Positioning during PCNL for complex kidney stones did not impact the success rates; consequently, both positions may be suitable. However, SUP might be associated with a lower high-grade complication rate.",2022,"SUP had a shorter operative time (117.9±39.1 vs. 147.6±38.8; p <0.001, minutes) and PRO had a higher rate of Clavien≥3 complications (14.3% vs. 3.6%; p=0.045).
","['inclusion criteria were patients over 18 years of age with complex stones', '112 patients']","['Supine Versus Prone Percutaneous Nephrolithotomy', 'SUP', 'supine (SUP) and prone (PRO) PCNL', 'supine to prone percutaneous nephrolithotomy (PCNL']","['rate of Clavien≥3 complications', 'shorter operative time', 'final SFR', 'Demographic, operative, and safety variables', 'success rate on POD1', 'stone-free rate on the 90th postoperative day (final SFR', 'success rate on the first postoperative day (POD1']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",112.0,0.223178,"SUP had a shorter operative time (117.9±39.1 vs. 147.6±38.8; p <0.001, minutes) and PRO had a higher rate of Clavien≥3 complications (14.3% vs. 3.6%; p=0.045).
","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Perrella', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Fabio C', 'Initials': 'FC', 'LastName': 'Vicentini', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Eliane D', 'Initials': 'ED', 'LastName': 'Paro', 'Affiliation': 'Department of Radiology, Hospital São Paulo, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fabio C M', 'Initials': 'FCM', 'LastName': 'Torricelli', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Giovani S', 'Initials': 'GS', 'LastName': 'Marchini', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Danilovic', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Batagello', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Priscila K V', 'Initials': 'PKV', 'LastName': 'Mota', 'Affiliation': 'Department of Urology, Hospital Brigadeiro, São Paulo, Brazil.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Ferreira', 'Affiliation': 'Department of Urology, Hospital Brigadeiro, São Paulo, Brazil.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'Department of Urology, Hospital Brigadeiro, São Paulo, Brazil.'}, {'ForeName': 'Claudio B', 'Initials': 'CB', 'LastName': 'Murta', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Joaquim F A', 'Initials': 'JFA', 'LastName': 'Claro', 'Affiliation': 'Department of Urology, Hospital Brigadeiro, São Paulo, Brazil.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Giusti', 'Affiliation': 'Department of Urology, IRCCS Ospedale San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Monga', 'Affiliation': 'Department of Urology, University of California, San Diego, California.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Nahas', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Srougi', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Mazzucchi', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, Brazil.'}]",The Journal of urology,['10.1097/JU.0000000000002291']
1129,34673326,Evaluation of the frequency following response as a predictive biomarker of response to cognitive training in schizophrenia.,"Neurophysiological biomarkers of auditory processing show promise predicting outcomes following auditory-based targeted cognitive training (TCT) in schizophrenia, but the viability of the frequency following response (FFR) as a biomarker has yet to be examined, despite its ecological and face validity for auditory-based interventions. FFR is an event-related potential (ERP) that reflects early auditory processing. We predicted that schizophrenia patients would show acute- and longer-term FFR malleability in the context of TCT. Patients were randomized to either TCT (n = 30) or treatment as usual (TAU; n = 22), and electroencephalography was recorded during rapid presentation of an auditory speech stimulus before treatment, after one hour of training, and after 30 h of training. Whereas patients in the TCT group did not show changes in FFR after training, amplitude reductions were observed in the TAU. FFR was positively associated with performance on a measure of single word-in-noise perception in the TCT group, and with a measure of sentence-in-noise perception in both groups. Psychometric reliability analyses of FFR scores indicated high internal consistency but low one-hour and 12-week test-rest reliability. These findings support the dissociation between measures of speech discriminability along the hierarchy of cortical and subcortical early auditory information processing in schizophrenia.",2021,"FFR was positively associated with performance on a measure of single word-in-noise perception in the TCT group, and with a measure of sentence-in-noise perception in both groups.","['schizophrenia', 'schizophrenia patients']","['auditory-based targeted cognitive training (TCT', 'cognitive training', 'TCT']","['FFR malleability', 'FFR', 'amplitude reductions']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.00866135,"FFR was positively associated with performance on a measure of single word-in-noise perception in the TCT group, and with a measure of sentence-in-noise perception in both groups.","[{'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Clayson', 'Affiliation': 'Department of Psychology, University of South Florida, University of California San Diego, 9500 Gilman Drive #0804 La Jolla, Tampa, CA 92093, USA.'}, {'ForeName': 'Juan L', 'Initials': 'JL', 'LastName': 'Molina', 'Affiliation': 'VISN 22 Mental Illness Research, Education and Clinical Center (MIRECC), San Diego VA Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Yash B', 'Initials': 'YB', 'LastName': 'Joshi', 'Affiliation': 'VISN 22 Mental Illness Research, Education and Clinical Center (MIRECC), San Diego VA Healthcare System, San Diego, CA, USA; Department of Psychiatry, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Sprock', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nungaray', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Neal R', 'Initials': 'NR', 'LastName': 'Swerdlow', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Light', 'Affiliation': 'VISN 22 Mental Illness Research, Education and Clinical Center (MIRECC), San Diego VA Healthcare System, San Diego, CA, USA; Department of Psychiatry, University of California San Diego, San Diego, CA, USA. Electronic address: glight@ucsd.edu.'}]",Psychiatry research,['10.1016/j.psychres.2021.114239']
1130,34697033,Effect of Metformin and Lifestyle Interventions on Mortality in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study.,"OBJECTIVE


To determine whether metformin or lifestyle modification can lower rates of all-cause and cause-specific mortality in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study.
RESEARCH DESIGN AND METHODS


From 1996 to 1999, 3,234 adults at high risk for type 2 diabetes were randomized to an intensive lifestyle intervention, masked metformin, or placebo. Placebo and lifestyle interventions stopped in 2001, and a modified lifestyle program was offered to everyone, but unmasked study metformin continued in those originally randomized. Causes of deaths through 31 December 2018 were adjudicated by blinded reviews. All-cause and cause-specific mortality hazard ratios (HRs) were estimated from Cox proportional hazards regression models and Fine-Gray models, respectively.
RESULTS


Over a median of 21 years (interquartile range 20-21), 453 participants died. Cancer was the leading cause of death ( n  = 170), followed by cardiovascular disease ( n  = 131). Compared with placebo, metformin did not influence mortality from all causes (HR 0.99 [95% CI 0.79, 1.25]), cancer (HR 1.04 [95% CI 0.72, 1.52]), or cardiovascular disease (HR 1.08 [95% CI 0.70, 1.66]). Similarly, lifestyle modification did not impact all-cause (HR 1.02 [95% CI 0.81, 1.28]), cancer (HR 1.07 [95% CI 0.74, 1.55]), or cardiovascular disease (HR 1.18 [95% CI 0.77, 1.81]) mortality. Analyses adjusted for diabetes status and duration, BMI, cumulative glycemic exposure, and cardiovascular risks yielded results similar to those for all-cause mortality.
CONCLUSIONS


Cancer was the leading cause of mortality among adults at high risk for type 2 diabetes. Although metformin and lifestyle modification prevented diabetes, neither strategy reduced all-cause, cancer, or cardiovascular mortality rates.",2021,"Compared with placebo, metformin did not influence mortality from all causes (HR 0.99","['adults at high risk for type 2 diabetes', 'From 1996 to 1999, 3,234 adults at high risk for type 2 diabetes']","['Placebo', 'Metformin and Lifestyle Interventions', 'intensive lifestyle intervention, masked metformin, or placebo', 'placebo, metformin', 'metformin']","['All-cause and cause-specific mortality hazard ratios (HRs', 'cardiovascular disease', 'Mortality', 'cause, cancer, or cardiovascular mortality rates', 'mortality', 'diabetes status and duration, BMI, cumulative glycemic exposure, and cardiovascular risks']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",3234.0,0.278006,"Compared with placebo, metformin did not influence mortality from all causes (HR 0.99","[{'ForeName': 'Christine G', 'Initials': 'CG', 'LastName': 'Lee', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD dppmail@bsc.gwu.edu.'}, {'ForeName': 'Brandy', 'Initials': 'B', 'LastName': 'Heckman-Stoddard', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Rockville, MD.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Dabelea', 'Affiliation': 'Department of Epidemiology and Lifecourse Epidemiology of Adiposity and Diabetes (LEAD) Center, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Kishore M', 'Initials': 'KM', 'LastName': 'Gadde', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ehrmann', 'Affiliation': 'University of Chicago, Chicago, IL.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Ford', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Rockville, MD.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Prorok', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Rockville, MD.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Boyko', 'Affiliation': 'Epidemiologic Research and Information Center, VA Puget Sound Health Care System, Seattle.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Amisha', 'Initials': 'A', 'LastName': 'Wallia', 'Affiliation': 'Division of Endocrinology, Metabolism and Molecular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ.'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Marinella', 'Initials': 'M', 'LastName': 'Temprosa', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc21-1046']
1131,34702785,The Impact of a 12-Month Activity Tracker Intervention on Activity Behavior Across Body Mass Index Subgroups Among Recent Retirees: Post Hoc Analysis of a Randomized Controlled Trial.,"BACKGROUND


This study examined the effectiveness of a 12-month activity tracker-based intervention on activity behavior among recent retirees (Enhancing physical ACTivity and healthy aging among recent REtirees [REACT]) in subgroups based on body mass index.
METHODS


REACT trial randomized 231 participants (mean age 65.2) into intervention and control groups. Main outcomes were accelerometer-measured moderate-to-vigorous (MVPA) and light physical activity (LPA) and sedentary time (SED) measured at baseline and 3-, 6-, and 12-month follow-ups. As a post hoc analysis, the intervention effect was examined among participants with normal weight (n = 77), overweight (n = 89), and obesity (n = 61).
RESULTS


An intervention effect was observed among participants with obesity in LPA (time × group P = .045) mirrored by a similar, albeit nonsignificant, effect in SED (P = .067), but not in MVPA (P = .92). A transient increase of 41 minutes per day (95% confidence interval, 14 to 68) in LPA was observed at 6 months among the intervention group, with a concomitant decrease of 42 minutes per day (-72 to -12) in SED. However, these changes were not maintained at 12 months. No between-group differences in changes over time were observed among participants with normal or overweight.
CONCLUSIONS


Activity trackers may be particularly suitable for promoting changes in LPA and SED among older adults with obesity. However, their long-term effectiveness might be limited.",2021,"A transient increase of 41 minutes per day (95% confidence interval, 14 to 68) in LPA was observed at 6 months among the intervention group, with a concomitant decrease of 42 minutes per day (-72 to -12) in SED.","['older adults with obesity', 'participants with normal weight (n = 77), overweight (n = 89), and obesity (n = 61', 'participants with normal or overweight', '231 participants (mean age 65.2) into intervention and control groups']","['Activity Tracker Intervention', 'activity tracker-based intervention']","['LPA', 'accelerometer-measured moderate-to-vigorous (MVPA) and light physical activity (LPA) and sedentary time (SED', 'Activity Behavior']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",231.0,0.0617483,"A transient increase of 41 minutes per day (95% confidence interval, 14 to 68) in LPA was observed at 6 months among the intervention group, with a concomitant decrease of 42 minutes per day (-72 to -12) in SED.","[{'ForeName': 'Miika', 'Initials': 'M', 'LastName': 'Tuominen', 'Affiliation': ''}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Suorsa', 'Affiliation': ''}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Pentti', 'Affiliation': ''}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Koski', 'Affiliation': ''}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Stenholm', 'Affiliation': ''}, {'ForeName': 'Tuija', 'Initials': 'T', 'LastName': 'Leskinen', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2021-0352']
1132,34702064,Associations of Early Systolic Blood Pressure Control and Outcome After Thrombolysis-Eligible Acute Ischemic Stroke: Results From the ENCHANTED Study.,"BACKGROUND AND PURPOSE


In thrombolysis-eligible patients with acute ischemic stroke, there is uncertainty over the most appropriate systolic blood pressure (SBP) lowering profile that provides an optimal balance of potential benefit (functional recovery) and harm (intracranial hemorrhage). We aimed to determine relationships of SBP parameters and outcomes in thrombolyzed acute ischemic stroke patients.
METHODS


Post hoc analyzes of the ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study), a partial-factorial trial of thrombolysis-eligible and treated acute ischemic stroke patients with high SBP (150-180 mm Hg) assigned to low-dose (0.6 mg/kg) or standard-dose (0.9 mg/kg) alteplase and intensive (target SBP, 130-140 mm Hg) or guideline-recommended (target SBP <180 mm Hg) treatment. All patients were followed up for functional status and serious adverse events to 90 days. Logistic regression models were used to analyze 3 SBP summary measures postrandomization: attained (mean), variability (SD) in 1-24 hours, and magnitude of reduction in 1 hour. The primary outcome was a favorable shift on the modified Rankin Scale. The key safety outcome was any intracranial hemorrhage.
RESULTS


Among 4511 included participants (mean age 67 years, 38% female, 65% Asian) lower attained SBP and smaller SBP variability were associated with favorable shift on the modified Rankin Scale (per 10 mm Hg increase: odds ratio, 0.76 [95% CI, 0.71-0.82];  P <0.001 and 0.86 [95% CI, 0.76-0.98];  P =0.025) respectively, but not for magnitude of SBP reduction (0.98, [0.93-1.04];  P =0.564). Odds of intracranial hemorrhage was associated with higher attained SBP and greater SBP variability (1.18 [1.06-1.31];  P =0.002 and 1.34 [1.11-1.62];  P =0.002) but not with magnitude of SBP reduction (1.05 [0.98-1.14];  P =0.184).
CONCLUSIONS


Attaining early and consistent low levels in SBP <140 mm Hg, even as low as 110 to 120 mm Hg, over 24 hours is associated with better outcomes in thrombolyzed acute ischemic stroke patients. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01422616.",2022,"Hg increase: odds ratio, 0.76","['4511 included participants (mean age 67 years, 38% female, 65% Asian) lower', 'After Thrombolysis-Eligible Acute Ischemic Stroke', 'thrombolysis-eligible and treated acute ischemic stroke patients with high SBP (150-180 mm Hg) assigned to low-dose (0.6 mg/kg) or', 'thrombolysis-eligible patients with acute ischemic stroke', 'thrombolyzed acute ischemic stroke patients']","['SBP', 'standard-dose (0.9 mg/kg) alteplase and intensive (target SBP, 130-140 mm Hg) or guideline-recommended (target SBP <180 mm Hg) treatment']","['SBP variability', 'favorable shift on the modified Rankin Scale', 'SBP reduction', 'Odds of intracranial hemorrhage', 'modified Rankin Scale', 'intracranial hemorrhage', 'attained SBP and smaller SBP variability', 'Early Systolic Blood Pressure Control and Outcome']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0277884', 'cui_str': 'Increased systolic arterial pressure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1277632', 'cui_str': 'Target systolic blood pressure'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",4511.0,0.151259,"Hg increase: odds ratio, 0.76","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia (X.W., T.J.M., G.L.D.T., X.C., H.A., C.D., M.W., J.C., L.S., C.S.A).'}, {'ForeName': 'Jatinder S', 'Initials': 'JS', 'LastName': 'Minhas', 'Affiliation': 'Department of Cardiovascular Sciences (J.S.M., T.G.R.), University of Leicester, United Kingdom.'}, {'ForeName': 'Tom J', 'Initials': 'TJ', 'LastName': 'Moullaali', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia (X.W., T.J.M., G.L.D.T., X.C., H.A., C.D., M.W., J.C., L.S., C.S.A).'}, {'ForeName': 'Gian', 'Initials': 'G', 'LastName': 'Luca Di Tanna', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia (X.W., T.J.M., G.L.D.T., X.C., H.A., C.D., M.W., J.C., L.S., C.S.A).'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Applied Research Centre (R.I.L.), University of Sydney, NSW, Australia.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia (X.W., T.J.M., G.L.D.T., X.C., H.A., C.D., M.W., J.C., L.S., C.S.A).'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia (X.W., T.J.M., G.L.D.T., X.C., H.A., C.D., M.W., J.C., L.S., C.S.A).'}, {'ForeName': 'Guofang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Xuzhou Central Hospital, China (G.C.).'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia (X.W., T.J.M., G.L.D.T., X.C., H.A., C.D., M.W., J.C., L.S., C.S.A).'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, School of Medicine, University of Nottingham, United Kingdom (P.M.B.).'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Broderick', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati Neuroscience Institute, University of Cincinnati, OH (J.P.B.).'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Demchuk', 'Affiliation': 'Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Canada (A.M.D.).'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'Melbourne Brain Centre, Royal Melbourne Hospital (G.A.D.), University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Alice C', 'Initials': 'AC', 'LastName': 'Durham', 'Affiliation': 'Department of Cardiovascular Sciences (J.S.M., T.G.R.), University of Leicester, United Kingdom.'}, {'ForeName': 'Pablo M', 'Initials': 'PM', 'LastName': 'Lavados', 'Affiliation': 'Department of Neurology and Psychiatry, Clinica Alemana de Santiago, Clinica Alemana Universidad del Desarrollo School of Medicine, Santiago, Chile (P.M.L., V.V.O.).'}, {'ForeName': 'Tsong-Hai', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan (T.-H.L.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Levi', 'Affiliation': 'University of Newcastle, School of Medicine and Public Health, University Drive, Callaghan, NSW, Australia (C.L.).'}, {'ForeName': 'Sheila O', 'Initials': 'SO', 'LastName': 'Martins', 'Affiliation': 'Stroke Division of Neurology Service, Hospital de Clinicas de Porto Alegre, University of Rio Grande do Sul, Porto Alegre, Brazil (S.O.M.).'}, {'ForeName': 'Veronica V', 'Initials': 'VV', 'LastName': 'Olavarria', 'Affiliation': 'Department of Neurology and Psychiatry, Clinica Alemana de Santiago, Clinica Alemana Universidad del Desarrollo School of Medicine, Santiago, Chile (P.M.L., V.V.O.).'}, {'ForeName': 'Jeyaraj D', 'Initials': 'JD', 'LastName': 'Pandian', 'Affiliation': 'Department of Neurology, Christian Medical College, Ludhiana, Punjab, India (J.D.P.).'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Neurology Department, Royal Melbourne Hospital (M.W.P.), University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Octavio M', 'Initials': 'OM', 'LastName': 'Pontes-Neto', 'Affiliation': 'Department of Neurosciences and Behavioral Sciences, University of Sao Paulo, Ribeirao Preto Medical School, Brazil (O.M.P.-N.).'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ricci', 'Affiliation': 'Uo Neurologia, USL Umbria 1, Sedi di Citta di Castello e Branca, Italy (S.R.).'}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan (S.S.).'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Sharma', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore and Division of Neurology, National University Hospital (V.K.S.).'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Silva', 'Affiliation': 'Neurovascular Sciences Group, Neurological Institute, Hospital Internacional de Colombia, Bucaramanga (F.S.).'}, {'ForeName': 'Nguyen H', 'Initials': 'NH', 'LastName': 'Thang', 'Affiliation': 'Department of Cerebrovascular Disease, The People 115 Hospital, Ho Chi Min, Vietnam (N.H.T.).'}, {'ForeName': 'Ji-Guang', 'Initials': 'JG', 'LastName': 'Wang', 'Affiliation': 'Shanghai Institute for Hypertension, Rui Jin Hospital and Shanghai Jiaotong University School of Medicine, China (J.-G.W.).'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia (X.W., T.J.M., G.L.D.T., X.C., H.A., C.D., M.W., J.C., L.S., C.S.A).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia (X.W., T.J.M., G.L.D.T., X.C., H.A., C.D., M.W., J.C., L.S., C.S.A).'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia (X.W., T.J.M., G.L.D.T., X.C., H.A., C.D., M.W., J.C., L.S., C.S.A).'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia (X.W., T.J.M., G.L.D.T., X.C., H.A., C.D., M.W., J.C., L.S., C.S.A).'}, {'ForeName': 'Thompson G', 'Initials': 'TG', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences (J.S.M., T.G.R.), University of Leicester, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.121.034580']
1133,34706268,Randomised controlled trial demonstrating the impact of behaviour change intervention provided by dental professionals to improve gingival health.,"AIMS


To determine impact of oral hygiene behaviour change intervention compared to the prevailing standard of oral hygiene advice provided in general dental practice, on bleeding on probing (BOP) in gingivitis patients, over 3-months. The effect of providing power-brushes was also evaluated.
MATERIALS AND METHODS


NHS dental practices were cluster-randomised to intervention or control (2:1). Dentists at intervention sites received behaviour modification training. Participants were stratified to high (≥20% BOP) or low (<20% BOP) presence of gingivitis and a subset assigned a power-brush. BOP and plaque scores were assessed at baseline and 3-months.
RESULTS


A total of 538 participants (369:169; intervention: control) completed the study. BOP reduced in both gingivitis groups with significantly greater reduction in intervention compared to control group (BOP:38% vs 19%, p = 0.0236); Borderline significance favouring the intervention was demonstrated for the low gingivitis group (BOP:37% vs 15%, p = 0.0523). A highly significant reduction in BOP (intervention vs control) was demonstrated for volunteers who swapped from manual to power-brush (44% vs 37%, p = 0.0039). Plaque score improved more in control than intervention group (Plaque:37% vs 44%, p = 0.00215).
CONCLUSIONS


Behaviour change techniques were readily mastered by the dental professional researchers. The introduction of an oral hygiene behaviour change intervention significantly reduced gingivitis in volunteer patients compared to control at 3 months. Swapping to a power-brush significantly favoured BOP reduction compared to manual brush continuation although plaque reduction did not follow expectation in comparison to BOP scores. Behaviour change techniques should routinely be considered in patient care.
CLINICAL SIGNIFICANCE


Plaque-induced gingivitis is highly prevalent in the UK despite being preventable with good oral hygiene. Its continuum, periodontitis, negative impacts quality of life. This study suggests oral hygiene behavioural interventions (GPS) significantly reduce gingivitis and that GPS introduction will improve oral health and may improve quality of life.",2021,The introduction of an oral hygiene behaviour change intervention significantly reduced gingivitis in volunteer patients compared to control at 3 months.,"['NHS dental practices were cluster-randomised to intervention or control (2:1', 'A total of 538 participants (369:169; intervention: control) completed the study', 'gingivitis patients, over 3-months', 'Participants were stratified to high (≥20% BOP) or low (<20% BOP) presence of gingivitis and a subset assigned a power-brush', 'volunteer patients']","['behaviour change intervention', 'behaviour modification training', 'oral hygiene behaviour change intervention', 'oral hygiene behavioural interventions (GPS']","['quality of life', 'gingivitis', 'bleeding on probing (BOP', 'BOP', 'BOP reduction', 'gingival health', 'BOP and plaque scores', 'Plaque score']","[{'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",538.0,0.0174664,The introduction of an oral hygiene behaviour change intervention significantly reduced gingivitis in volunteer patients compared to control at 3 months.,"[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Holloway', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol BS1 2LY, United Kingdom. Electronic address: jessica.naylor@bristol.ac.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol BS1 2LY, United Kingdom. Electronic address: maria.davies@bristol.ac.uk.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'McCarthy', 'Affiliation': ""King's College London, WC2R 2LS, United Kingdom. Electronic address: claire.mccarthy@qstt.nhs.uk.""}, {'ForeName': 'Iftekhar', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'University of Warwick, CV4 7AL, United Kingdom. Electronic address: i.khan.2@warwick.ac.uk.'}, {'ForeName': 'Nicholas C A', 'Initials': 'NCA', 'LastName': 'Claydon', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol BS1 2LY, United Kingdom. Electronic address: n.claydon@bristol.ac.uk.'}, {'ForeName': 'Nicola X', 'Initials': 'NX', 'LastName': 'West', 'Affiliation': 'Clinical Trials Group, School of Oral and Dental Sciences, University of Bristol, Lower Maudlin Street, Bristol BS1 2LY, United Kingdom. Electronic address: N.X.West@bristol.ac.uk.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103862']
1134,34704605,Is neural network better than logistic regression in death prediction in patients after ST-segment elevation myocardial infarction?,"BACKGROUND


There is a need to develop patient classification methods and adjust post-discharge care to improve survival after ST-segment elevation myocardial infarction (STEMI).
AIMS


The study aimed to determine whether a neural network (NN) is better than logistic regression (LR) in mortality prediction in STEMI patients.
METHODS


The study included patients from the Polish Registry of Acute Coronary Syndromes (PL-ACS). Patients with the first anterior STEMI treated with the primary percutaneous coronary intervention (pPCI) of the left anterior descending (LAD) artery between 2009 and 2015 and discharged alive were included in the study. Patients were randomly divided into three groups: learning (60%), validation (20%), and test group (20%). Two models (LR and NN) were developed to predict 6-month all-cause mortality. The predictive values of LR and NN were evaluated with the Area Under the Receiver Operating Characteristics Curve (AUROC), and the comparison of AUROC for learning and test groups was performed. Validation of both methods was performed in the same group.
RESULTS


Out of 175 895 patients with acute coronary syndrome, 17 793 were included in the study. The 6-month all-cause mortality was 5.9%. Both NN and LR had good predictive values. Better results were obtained in the NN approach regarding the statistical quality of the models - AUROC 0.8422 vs. 0.8137 for LR (P <0.0001). AUROCs in the test groups were 0.8103 and 0.7939, respectively (P = 0.037).
CONCLUSIONS


The neural network may have a better predictive value for mortality than logistic regression in patients after the first STEMI.",2021,Better results were obtained in the NN approach regarding the models' statistical quality - AUROC 0.8422 vs 0.8137 for LR (P <0.0001).,"['patients from the Polish Registry of Acute Coronary Syndromes (PL-ACS', 'STEMI patients', 'Patients with the first anterior STEMI treated with the primary percutaneous coronary intervention (pPCI) of the left anterior descending (LAD) artery between 2009 and 2015 and discharged alive were included in the study', '175,895 patients with acute coronary syndrome', '17 793 were included in the study']",['neural network (NN'],['6-month mortality'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0441998', 'cui_str': 'Left anterior'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",175895.0,0.0676617,Better results were obtained in the NN approach regarding the models' statistical quality - AUROC 0.8422 vs 0.8137 for LR (P <0.0001).,"[{'ForeName': 'Jacek T', 'Initials': 'JT', 'LastName': 'Niedziela', 'Affiliation': '3rd Department of Cardiology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland. jacek@niedziela.org.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cieśla', 'Affiliation': 'Department of Science, Education and New Medical Technologies, Silesian Center for Heart Disease, Zabrze, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Wojakowski', 'Affiliation': 'Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Gierlotka', 'Affiliation': 'Department of Cardiology, Institute of Medical Sciences, University of Opole, Opole, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': '2nd Department of Clinical Cardiology and Cardiovascular Interventions, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Witkowski', 'Affiliation': 'Department of Interventional Cardiology and Angiology, Institute of Cardiology, Warszawa, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Zdrojewski', 'Affiliation': 'Department of Preventive Medicine and Education, Medical University of Gdansk, Gdańsk, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Lesiak', 'Affiliation': 'Department of Cardiology, Poznan University of Medical Sciences, Poznań, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'American Heart of Poland, Katowice, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Gąsior', 'Affiliation': '3rd Department of Cardiology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland.'}]",Kardiologia polska,['10.33963/KP.a2021.0142']
1135,34700011,Radiation-Shielding Devices: The Best Combination for Spine Interventional Procedures.,"PURPOSE


Although many studies have examined the efficiency of various protective devices for reducing the dose of radiation exposure to physicians during interventional pain procedures, no study has compared the protective effect of these devices when they are used in combination. The purpose of this prospective experimental study was to determine the best combination of radiation-shielding devices.
MATERIALS AND METHODS


Using anthropomorphic phantoms of a physician and patient, we measured the radiation protection efficiency (RPE) of each of the following protection methods and in combination during C-arm-guided simulated lumbar epidural injection: (a) personal protective equipment (PPE), (b) bedside curtain shield (Curtain), (c) x-ray tube filter (Filter), and (d) fluoroscopic collimation method (Collimation). We measured exposure doses using personal electronic dosimeters at the eye, thyroid, and gonad levels for 1 minute. Each experiment was repeated 15 times.
RESULTS


The radiation exposure dose and RPE with the best single-, double-, and triple-protection methods were as follows: PPE for the single-protection method (11.82 μSv/min, 80.04%), PPE + Collimation for the double-combination method (4.68 μSv/min, 92.09%), and PPE + Collimation + Curtain for the triple-combination method (3.08 μSv/min, 93.39%). Additionally, PPE + Collimation + Curtain + Filter for the quadruple-combination method resulted in a radiation exposure and RPE of 2.91 μSv/min and 93.61%, respectively, compared with nonprotection.
CONCLUSIONS


The best single-, double-, and triple-protection method was PPE, PPE + Collimation, and PPE + Collimation + Curtain, respectively. While preparing protective equipment, we recommend prioritizing equipment in this order.",2022,"PPE for the single protection method (11.82 μSv/min, 80.04%), PPE + Collimation for the double combination (4.68 μSv/min, 92.09%), and PPE + Collimation + Curtain for the triple combination (3.08 μSv/min, 93.39%).",[],"['Radiation-Shielding Devices', 'protection methods and in combination during C-arm-guided simulated lumbar epidural injection: (1) personal protective equipment (PPE), (2) bedside curtain shield (Curtain), (3) X-ray tube filter (Filter), and (4) fluoroscopic collimation method (Collimation', 'radiation-shielding devices']","['PPE + Collimation', 'radiation protection efficacy (RPE', 'radiation exposure and RPE level']",[],"[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0581283', 'cui_str': 'Injection into lumbar epidural space'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0180239', 'cui_str': 'Curtain'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0454169', 'cui_str': 'Collimator'}]","[{'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0454169', 'cui_str': 'Collimator'}, {'cui': 'C0034533', 'cui_str': 'Protection, Radiation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0866709,"PPE for the single protection method (11.82 μSv/min, 80.04%), PPE + Collimation for the double combination (4.68 μSv/min, 92.09%), and PPE + Collimation + Curtain for the triple combination (3.08 μSv/min, 93.39%).","[{'ForeName': 'Young Seok', 'Initials': 'YS', 'LastName': 'Ji', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Eun Kyul', 'Initials': 'EK', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Hyuk Chan', 'Initials': 'HC', 'LastName': 'Kwon', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Woong Ki', 'Initials': 'WK', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Francis Sahngun', 'Initials': 'FS', 'LastName': 'Nahm', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea; Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, South Korea. Electronic address: hiitsme@hanmail.net.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2021.10.008']
1136,34699954,Bioactive self-etching sealant on newly erupted molars: A split-mouth clinical trial.,"OBJECTIVES


This randomized clinical trial compares retention, survival rate, and evolution of caries of newly erupted permanent molars sealed with bioactive self-etching sealants with pre-reacted glass ionomer (S-PRG).
METHODS


A split-mouth clinical trial was conducted with 56 permanent second molars in stages 2 and 3 of crown eruption; ICDAS (International Caries Detection and Assessment System) was between 0 and 2. The molars were randomized and blinded in relation to the side (right or left) that would receive the sealants; the conventional resin sealant (FS), Fluroshield (Dentsply), or bioactive self-etch sealant (BS), BeautiSealant with S-PRG (Shofu). The sealants were compared in terms of retention, quality of sealant remnant (anatomical shape, marginal adaptation, surface texture, and marginal discoloration), and development of caries by ICDAS after 1, 6, and 12 months. The Wilcoxon, x² of independence, Kaplan-Meier, and Mantel-Cox survival statistical tests were applied (α = 5%).
RESULTS


The total retention was higher for FS (57.1%) at all periods, and there was no difference in the quality of sealants at all periods. The ICDAS decreased after 6 (p = 0.025) and 12 months (p = 0.027) for both materials. Despite the lower retention of BS, the clinical quality of sealants over 12 months were similar.
CONCLUSION


Teeth sealed with BS presented higher sound teeth predominance (ICDAS 0) compared to FS sealant, even with a higher loss of material.
CLINICAL RELEVANCE


Eruption of permanent molars is a relevant period, and the prevention/management of initial caries is essential in these critical stages. Sealants can be an important prevention strategy. After 12 months of follow-up, there was a major failure of the bioactive sealant but without the development of caries lesions.",2021,The ICDAS decreased after 6 (p = 0.025) and 12 months (p = 0.027) for both materials.,"['of newly erupted permanent molars sealed with bioactive self-etching sealants with pre-reacted glass ionomer (S-PRG', 'Eruption of permanent molars', 'newly erupted molars', '56 permanent second molars in stages 2 and 3 of crown eruption; ICDAS (International Caries Detection and Assessment System) was between 0 and 2']","['conventional resin sealant (FS), Fluroshield (Dentsply), or bioactive self-etch sealant (BS), BeautiSealant with S-PRG (Shofu', 'Bioactive self-etching sealant', 'FS sealant']","['Wilcoxon, x² of independence, Kaplan-Meier, and Mantel-Cox survival', 'quality of sealants', 'total retention', 'retention, survival rate, and evolution of caries', 'retention, quality of sealant remnant (anatomical shape, marginal adaptation, surface texture, and marginal discoloration), and development of caries by ICDAS', 'ICDAS']","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0061297', 'cui_str': 'glass ionomer'}]","[{'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",,0.130706,The ICDAS decreased after 6 (p = 0.025) and 12 months (p = 0.027) for both materials.,"[{'ForeName': 'Karla Janilee de Souza', 'Initials': 'KJS', 'LastName': 'Penha', 'Affiliation': 'Dental Post-Graduation Program, Department of Dentistry, Federal University of Maranhão (UFMA), São Luís- MA, Brasil.'}, {'ForeName': 'Fábia Regina Vieira de Oliveira', 'Initials': 'FRVO', 'LastName': 'Roma', 'Affiliation': 'Dental Post-Graduation Program, Department of Dentistry, Federal University of Maranhão (UFMA), São Luís- MA, Brasil.'}, {'ForeName': 'Etevaldo Matos Maia', 'Initials': 'EMM', 'LastName': 'Filho', 'Affiliation': 'Programa de pós-graduação em Odontologia, Universidade CEUMA, São Luís-MA, Brasil.'}, {'ForeName': 'Cecilia Claudia Costa', 'Initials': 'CCC', 'LastName': 'Ribeiro', 'Affiliation': 'Dental Post-Graduation Program, Department of Dentistry, Federal University of Maranhão (UFMA), São Luís- MA, Brasil; Department of Dentistry II, Federal University of Maranhão, São Luís- MA, Brasil.'}, {'ForeName': 'Leily Macedo', 'Initials': 'LM', 'LastName': 'Firoozmand', 'Affiliation': 'Dental Post-Graduation Program, Department of Dentistry, Federal University of Maranhão (UFMA), São Luís- MA, Brasil; Department of Dentistry I, Federal University of Maranhão, São Luís- MA, Brasil. Electronic address: leily.firoozmand@ufma.br.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103857']
1137,34704393,Measuring treatment response to advance precision medicine for multiple sclerosis.,"OBJECTIVE


To assess the independent contributions of clinical measures (relapses, Expanded Disability Status Scale [EDSS] scores, and neuroperformance measures) and nonclinical measures (new brain magnetic resonance imaging [MRI] activity and serum neurofilament light chain [sNfL] levels) for distinguishing natalizumab-treated from placebo-treated patients.
METHODS


We conducted post hoc analyses using data from the AFFIRM trial of natalizumab for multiple sclerosis. We used multivariable regression analyses with predictors (EDSS progression, no relapse, new or enlarging MRI activity, brain atrophy, sNfL levels, and neuroperformance worsening) to identify measures that independently discriminated between treatment groups.
RESULTS


The multivariable model that best distinguished natalizumab from placebo was no new or enlarging T2 or gadolinium-enhancing activity on MRI (odds ratio; 95% confidence interval: 7.2; 4.7-10.9), year 2 sNfL levels <97.5th percentile (4.1; 2.6-6.2), and no relapses in years 0-2 (2.1; 1.5-3.0). The next best-fitting model was a two-component model that included no MRI activity and sNfL levels <97.5th percentile at year 2. There was little difference between the three- and two-component models.
INTERPRETATION


Nonclinical measures (new MRI activity and sNfL levels) discriminate between treatment and placebo groups similarly to or better than clinical outcomes composites and have implications for patient monitoring.",2021,"The multivariable model that best distinguished natalizumab from placebo was no new or enlarging T2 or gadolinium-enhancing activity on MRI (odds ratio; 95% confidence interval: 7.2; 4.7-10.9), year 2 sNfL levels <97.5th percentile (4.1; 2.6-6.2), and no relapses in years 0-2 (2.1; 1.5-3.0).",['treated patients'],['placebo'],"['clinical measures (relapses, Expanded Disability Status Scale [EDSS] scores, and neuroperformance measures) and nonclinical measures (new brain magnetic resonance imaging [MRI] activity and serum neurofilament light chain [sNfL] levels', 'MRI activity and sNfL levels', 'predictors (EDSS progression, no relapse, new or enlarging MRI activity, brain atrophy, sNfL levels, and neuroperformance worsening']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C1562562', 'cui_str': 'Light chain level'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]",,0.128821,"The multivariable model that best distinguished natalizumab from placebo was no new or enlarging T2 or gadolinium-enhancing activity on MRI (odds ratio; 95% confidence interval: 7.2; 4.7-10.9), year 2 sNfL levels <97.5th percentile (4.1; 2.6-6.2), and no relapses in years 0-2 (2.1; 1.5-3.0).","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Calabresi', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Blizzard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Plavina', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Koulinska', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Edwards', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Kieseier', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'de Moor', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Elias S', 'Initials': 'ES', 'LastName': 'Sotirchos', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Fisher', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Rudick', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Sandrock', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51471']
1138,34714203,A novel intragastric balloon for treatment of obesity and type 2 diabetes. A two-center pilot trial.,"BACKGROUND AND AIMS


Obesity with type-2 diabetes is a global challenge. Lifestyle interventions have limited effect for most patients. Bariatric surgery is highly effective, but resource-demanding, invasive and associated with serious complications. Recently, a new intragastric balloon was introduced, not requiring endoscopy for placement or removal (Elipse™, Allurion Inc., Natick, MA). The balloon is swallowed in a capsule and filled with water once in the stomach. The balloon self-deflates after 4 months and is naturally excreted. The present trial investigated balloon feasibility, safety and efficacy in patients with obesity and type-2 diabetes.
PATIENTS AND METHODS


We treated 19 patients, with type-2 diabetes and body mass index (BMI) of 30.0-39.9 kg/m 2  at two Norwegian centers with the Elipse balloon. Patient follow-up during balloon treatment mimicked real-world clinical practice, including dietary plan and outpatient visits. The primary efficacy endpoints were total body weight loss (TBWL) and HbA1c at weeks 16 and 52.
RESULTS


All patients underwent balloon insertion uneventfully as out-patients. Mean TBWL and HbA1c reduction after 16 and 52 weeks of balloon insertion was 3.9% (95%CI 2.1-5.7) and 0.8% (95%CI 1.9-3.5); and 7 (95%CI 4-10), and 1 (95%CI -6 to 9) mmol/mol, respectively. Adverse events occurred in two patients (10.5%): one developed gastric outlet obstruction, managed by endoscopic balloon removal; the other excessive vomiting and dehydration, managed conservatively.
CONCLUSIONS


This first Scandinavian real-world clinical trial with a new minimally invasive intragastric balloon system demonstrated good feasibility, but did not confirm expected efficacy for weight loss and diabetes control.",2022,"This first Scandinavian real-world clinical trial with a new minimally invasive intragastric balloon system demonstrated good feasibility, but did not confirm expected efficacy for weight loss and diabetes control.","['patients with obesity and type-2 diabetes', 'obesity and type 2 diabetes', 'We treated 19 patients, with type-2 diabetes and body mass index (BMI) of 30.0-39.9\u2009kg/m 2  at two Norwegian centers with the Elipse balloon']","['Bariatric surgery', 'intragastric balloon', 'balloon insertion']","['balloon feasibility, safety and efficacy', 'Adverse events', 'excessive vomiting and dehydration, managed conservatively', 'Mean TBWL and HbA1c reduction', 'total body weight loss (TBWL) and HbA1c at weeks 16 and 52', 'gastric outlet obstruction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034194', 'cui_str': 'Pyloric stenosis'}]",,0.103705,"This first Scandinavian real-world clinical trial with a new minimally invasive intragastric balloon system demonstrated good feasibility, but did not confirm expected efficacy for weight loss and diabetes control.","[{'ForeName': 'Christer Julseth', 'Initials': 'CJ', 'LastName': 'Tønnesen', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jøran', 'Initials': 'J', 'LastName': 'Hjelmesæth', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Hofsø', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Tonstad', 'Affiliation': 'Preventive Cardiology, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital Aker, Oslo, Norway.'}, {'ForeName': 'Jens Kristoffer', 'Initials': 'JK', 'LastName': 'Hertel', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Heggen', 'Affiliation': 'Preventive Cardiology, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital Aker, Oslo, Norway.'}, {'ForeName': 'Line Kristin', 'Initials': 'LK', 'LastName': 'Johnson', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Tor Erik', 'Initials': 'TE', 'LastName': 'Mathisen', 'Affiliation': 'Department of Gastroenterology, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Kalager', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Wieszczy', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Asle W', 'Initials': 'AW', 'LastName': 'Medhus', 'Affiliation': 'Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Løberg', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Aabakken', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bretthauer', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo, Oslo, Norway.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2021.1994641']
1139,34700344,Dose-finding study of ibrutinib and venetoclax in relapsed or refractory mantle cell lymphoma.,"Relapsed Mantle cell lymphoma (MCL) is often treated with Bruton's tyrosine kinase inhibitors (BTKi); however, post-BTKi relapse can be challenging. Adding venetoclax (VEN) to ibrutinib (IBR) has shown synergy in preclinical MCL models. Prior MCL studies of the combination show promising efficacy but have conducted limited dose finding. We sought to identify the optimal dosing combination, based on efficacy and toxicity, utilizing a continual reassessment method of 6 combinations of IBR (280 mg, 420 mg, and 560 mg by mouth daily) and VEN (max dose of 200 mg and 400 mg by mouth daily). Eligible participants were not previously exposed to BTKi and not high risk for tumor lysis syndrome (TLS). VEN, initiated first at 100 mg, then at 20 mg by mouth daily after a TLS event, was started prior to adding IBR and ramped-up based on the dose level assigned. Combination treatment continued for six 28-day cycles. Thirty-five participants were enrolled and treated. One TLS event occurred with starting dose of 100 mg VEN; no TLS was seen with 20 mg. The optimal dosing combination was considered to be VEN 200 mg and IBR 420 mg with an overall response rate (ORR) of 93.8% (95% CI: 73.6% to 99.7%) and DLT incidence of 6.2% (95% CI: 0.3% to 26.4%). ORR for all arms was 82.3% (28/34; 95% CI: 65.5% to 93.2%) with a complete response (CR) rate of 42.4% (14/33; 95% CI: 25.5% to 60.8%). A participant was not allocated to IBR 560 mg and VEN 400 mg. ORR benefit was not seen with higher dosing combinations and toxicity was higher; a comparison made within the limitations of small cohorts. Resistance was seen in nearly all arms. This trial was registered at www.clinicaltrials.gov #NCT02419560.",2022,Overall response for all arms was 82.3% (28/34; 95% CI: 65.5-93.2%) with a CR rate of 42.4% (14/33; 95% CI: 25.5-60.8%).,"['35 participants were enrolled and treated', 'Relapsed Mantle cell lymphoma (MCL', 'Relapsed or Refractory Mantle Cell Lymphoma', ""Eligible participants were not previously exposed to BTKi's and not high risk for Tumor Lysis Syndrome (TLS""]","['IBR 560mg and VEN', 'venetoclax (VEN) to ibrutinib(IBR', 'Ibrutinib and Venetoclax', 'VEN', 'IBR']","['DLT incidence', 'Overall response', 'ORR benefit', 'efficacy and toxicity', 'Resistance', 'TLS']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0334634', 'cui_str': 'Mantle cell lymphoma'}, {'cui': 'C0855138', 'cui_str': 'Mantle cell lymphoma refractory'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C4521488', 'cui_str': 'Non-specific protein-tyrosine kinase inhibitor'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0041364', 'cui_str': 'Tumor lysis syndrome'}]","[{'cui': 'C4555389', 'cui_str': 'Ibrutinib 560 MG'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0041364', 'cui_str': 'Tumor lysis syndrome'}]",35.0,0.268359,Overall response for all arms was 82.3% (28/34; 95% CI: 65.5-93.2%) with a CR rate of 42.4% (14/33; 95% CI: 25.5-60.8%).,"[{'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Portell', 'Affiliation': 'Division of Hematology and Oncology.'}, {'ForeName': 'Nolan A', 'Initials': 'NA', 'LastName': 'Wages', 'Affiliation': 'Cancer Center, and.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': 'Oncology Division, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Lihua E', 'Initials': 'LE', 'LastName': 'Budde', 'Affiliation': 'City of Hope National Medical Center, Duarte, CA; and.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Chen', 'Affiliation': 'City of Hope National Medical Center, Duarte, CA; and.'}, {'ForeName': 'Jonathon B', 'Initials': 'JB', 'LastName': 'Cohen', 'Affiliation': 'Emory University/Winship Cancer Institute, Atlanta, GA.'}, {'ForeName': 'Nikole E', 'Initials': 'NE', 'LastName': 'Varhegyi', 'Affiliation': 'Cancer Center, and.'}, {'ForeName': 'Gina R', 'Initials': 'GR', 'LastName': 'Petroni', 'Affiliation': 'Cancer Center, and.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Williams', 'Affiliation': 'Division of Hematology and Oncology.'}]",Blood advances,['10.1182/bloodadvances.2021005357']
1140,34709010,Effects of dexmedetomidine on glucose-related hormones and lactate in non-diabetic patients under general anesthesia: a randomized controlled trial.,"BACKGROUND


The aim of this study was to explore the effects of dexmedetomidine on glucose-related hormones and lactate levels in non-diabetic patients undergoing malignant gastrointestinal tumor radical resection.
METHODS


Groups D<inf>1</inf> and D<inf>2</inf> received dexmedetomidine loading dose 1 µg/kg and maintenance dose 0.25 and 0.5 µg/kg/h, respectively. Group C received saline solution. Glucose, lactate, insulin, glucagon, cortisol, epinephrine, norepinephrine and dopamine levels were measured before dexmedetomidine infusion (T<inf>1</inf>), 1 h after surgery beginning (T<inf>2</inf>), at surgery ending (T<inf>3</inf>), and 1 h after transfer to the postanesthesia care unit (T<inf>4</inf>).
RESULTS


Compared with group C, glucose levels increased in group D<inf>2</inf> at T<inf>2</inf> and reduced in groups D<inf>1</inf> and D<inf>2</inf> at T<inf>4</inf>. Lactate levels reduced in groups D<inf>1</inf> and D<inf>2</inf> at T<inf>4</inf>. A positive correlation between glucose and lactate levels was found in all groups. Compared with group C, insulin level reduced in group D<inf>2</inf> at T<inf>2</inf>; glucagon levels reduced in groups D<inf>1</inf> and D<inf>2</inf> at T<inf>4</inf>; cortisol levels reduced in group D<inf>1</inf> at T<inf>4</inf> and in group D<inf>2</inf> at T<inf>3</inf> and T<inf>4</inf>; epinephrine and norepinephrine levels reduced in group D<inf>1</inf> at T<inf>4</inf> and in group D<inf>2</inf> at T<inf>2</inf> and T<inf>4</inf>; and dopamine level reduced in group D<inf>2</inf> at T<inf>4</inf>.
CONCLUSIONS


Dexmedetomidine loading dose 1 µg/kg and maintenance dose 0.25 µg/kg/h produces a stable insulin level and significant postoperative decreases in glucagon, cortisol, epinephrine and norepinephrine secretion with stable maintenance of intraoperative and postoperative blood glucose levels and decreased postoperative lactate levels in non-diabetic patients under general anesthesia.",2022,"Compared with group C, insulin level reduced in group D2 at T2; glucagon levels reduced in groups D1 and D2 at T4; cortisol levels reduced in group D1 at T4 and in group D2 at T3 and T4; epinephrine and norepinephrine levels reduced in group D1 at T4 and in group D2 at T2 and T4; and dopamine level reduced in group D2 at T4.
","['non-diabetic patients under general anesthesia', 'non-diabetic patients undergoing malignant gastrointestinal tumor radical resection']","['saline solution', 'dexmedetomidine', 'Dexmedetomidine']","['Lactate levels', 'glucagon levels', 'glucose-related hormones and lactate', 'insulin level', 'dopamine level', 'glucose and lactate levels', 'glucose levels', 'Glucose, lactate, insulin, glucagon, cortisol, epinephrine, norepinephrine and dopamine levels', 'postoperative lactate levels', 'cortisol levels', 'glucagon, cortisol, epinephrine and norepinephrine secretion with stable maintenance of intraoperative and postoperative blood glucose levels', 'norepinephrine levels']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0017185', 'cui_str': 'Neoplasm of gastrointestinal tract'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0337437', 'cui_str': 'Glucagon measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",,0.085514,"Compared with group C, insulin level reduced in group D2 at T2; glucagon levels reduced in groups D1 and D2 at T4; cortisol levels reduced in group D1 at T4 and in group D2 at T3 and T4; epinephrine and norepinephrine levels reduced in group D1 at T4 and in group D2 at T2 and T4; and dopamine level reduced in group D2 at T4.
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Jiahua', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Shunping', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Tan', 'Affiliation': 'School of Medicine, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sui', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou, China - zhangzhuancg@163.com.'}]",Minerva anestesiologica,['10.23736/S0375-9393.21.15734-7']
1141,34706398,Immersive virtual reality simulated learning environment versus role-play for empathic clinical communication training.,"INTRODUCTION


The use of immersive virtual reality simulated learning environments (VR SLEs) for improving clinical communication can offer desirable qualities including repetition and determinism in a safe environment. The aim of this study was to establish whether the mode of delivery, VR SLE versus clinical role-play, could have a measurable effect on clinical empathic communication skills for MRI scenarios.
METHODS


A split-cohort study was performed with trainee practitioners (n = 70) and qualified practitioners (n = 9). Participants were randomly assigned to four groups: clinician VR (CVR), clinician role-play (CRP), trainee VR (TVR), and trainee RP (TRP). Clinical communication skills were assessed using two methods: firstly, a self-reported measure - the SE-12 communication questionnaire and, secondly, a training and assessment tool developed by a panel of experts.
RESULTS


Participants in the VR trainee (TVR) and clinician (CVR) groups reported 11% (P < 0.05) and 7.2% (P < 0.05) improvements in communication confidence post training, whereas trainees assigned to the role-play (TRP) intervention reported a 4.3% (P < 0.05) improvement. Empirical assessment of communication training scores assessing a participant's ability to select empathic statements showed the TVR group performed 5% better on average than their role-play counterparts (P < 0.05).
CONCLUSION


The accuracy of participant's selection of appropriate empathic responses was shown to differ significantly following the training intervention designed to improve interactions with patients that present for an MRI scan. The results may demonstrate the capacity for immersion into an emotional narrative in a VR environment to increase the user's susceptibility for recalling and selecting empathic terminology.",2022,The accuracy of participant's selection of appropriate empathic responses was shown to differ significantly following the training intervention designed to improve interactions with patients that present for an MRI scan.,['A split-cohort study was performed with trainee practitioners (n\u2009=\u200970) and qualified practitioners (n\u2009=\u20099'],"['immersive virtual reality simulated learning environments (VR SLEs', 'clinician VR (CVR), clinician role-play (CRP), trainee VR (TVR), and trainee RP (TRP']",[],"[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}]",[],,0.0153585,The accuracy of participant's selection of appropriate empathic responses was shown to differ significantly following the training intervention designed to improve interactions with patients that present for an MRI scan.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sapkaroski', 'Affiliation': 'Department of Medical Imaging & Radiation Sciences, Faculty of Medicine, Nursing & Health Sciences, School of Biomedical Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Mundy', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Matthew Richard', 'Initials': 'MR', 'LastName': 'Dimmock', 'Affiliation': 'Department of Medical Imaging & Radiation Sciences, Faculty of Medicine, Nursing & Health Sciences, School of Biomedical Sciences, Monash University, Clayton, Victoria, Australia.'}]",Journal of medical radiation sciences,['10.1002/jmrs.555']
1142,34676690,"Dose-effect relation between regular consumption of 100% cocoa powder and blood pressure in young, healthy black Africans.","BACKGROUND


Some previous works have focused on dose-response relationship between cocoa consumption and blood pressure in Caucasians. As black subjects have lower nitric oxide bioavailability, the aim of this work was to determine the dose-effect relation between cocoa and blood pressure in black Africans.
METHOD


One hundred and thirty healthy black African males aged 18-30 were randomly assigned into four groups: three groups consuming 10 g, 5 g, or 2 g of cocoa powder daily for three weeks and one control group that did not consume cocoa. Systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) were measured on day 1 (D1, before any subject consumed cocoa), D8, D15, and D22. Means of the parameters at each of the four visits and changes of the means were compared among the groups.
RESULTS


Significant decrease in SBP was noted in consumers of 10 g compared to controls in the 1st week, and compared to consumers of 2 g in the 2nd and 3rd weeks of follow-up. Means and changes of DBP were statistically similar among the four groups.
CONCLUSION


Among our cohort, decrease in SBP was significantly greater in the heavy cocoa consumer group (10 g) compared to the low consumer group (2 g), but there was no statistically significant difference when compared with the intermediate consumer group (5 g). The dose-response relationship between cocoa consumption and changes in SBP was not linear. No relationship was found between cocoa consumption and DBP.",2021,", decrease in SBP was significantly greater in the heavy cocoa consumer group (10 g) compared to the low consumer group (2 g), but there was no statistically significant difference when compared with the intermediate consumer group (5 g).","['Caucasians', 'One hundred and thirty healthy black African males aged 18-30', 'young, healthy black Africans']","['cocoa powder daily for three weeks and one control group that did not consume cocoa', 'regular consumption of 100% cocoa powder and blood pressure']","['nitric oxide bioavailability', 'DBP', 'cocoa consumption and DBP', 'SBP', 'Systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0337824', 'cui_str': 'Black African'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0009209', 'cui_str': 'Cocoa Powder'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",130.0,0.0377639,", decrease in SBP was significantly greater in the heavy cocoa consumer group (10 g) compared to the low consumer group (2 g), but there was no statistically significant difference when compared with the intermediate consumer group (5 g).","[{'ForeName': 'Edwige', 'Initials': 'E', 'LastName': 'Balayssac-Siransy', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Soualiho', 'Initials': 'S', 'LastName': 'Ouattara', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Kotchi Joël Michée', 'Initials': 'KJM', 'LastName': 'Boka', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Ahiboh', 'Affiliation': ""Laboratoire de Biochimie, Unité de Formation et de Recherche en Sciences Pharmaceutiques et Biologiques, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Téniloh Augustin', 'Initials': 'TA', 'LastName': 'Yéo', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Paule-Denise', 'Initials': 'PD', 'LastName': 'Yapo', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Aya Liliane', 'Initials': 'AL', 'LastName': 'Kondo', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Walamitien Cyrille', 'Initials': 'WC', 'LastName': 'Touré', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Kotchi Fabrice', 'Initials': 'KF', 'LastName': 'Edé', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Cyrille Serges', 'Initials': 'CS', 'LastName': 'Dah', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Bogui', 'Affiliation': ""Laboratoire de Physiologie et d'Explorations Fonctionnelles, Unité de Formation et de Recherche en Sciences Médicales, Université Félix Houphouët-Boigny, Abidjan, Côte d'Ivoire.""}]",Physiological reports,['10.14814/phy2.15070']
1143,34709880,Response-Adapted Postinduction Strategy in Patients With Advanced-Stage Follicular Lymphoma: The FOLL12 Study.,"PURPOSE


We compared 2 years of rituximab maintenance (RM) with a response-adapted postinduction approach in patients with follicular lymphoma who responded to induction immunochemotherapy.
METHODS


We randomly assigned treatment-naïve, advanced-stage, high-tumor burden follicular lymphoma patients to receive standard RM or a response-adapted postinduction approach on the basis of metabolic response and molecular assessment of minimal residual disease (MRD). The experimental arm used three types of postinduction therapies: for complete metabolic response (CMR) and MRD-negative patients, observation; for CMR and MRD-positive (end of induction or follow-up) patients, four doses of rituximab (one per week, maximum three courses) until MRD-negative; and for non-CMR patients, one dose of ibritumomab tiuxetan followed by standard RM. The study was designed as noninferiority trial with progression-free survival (PFS) as the primary end point.
RESULTS


Overall, 807 patients were randomly assigned. After a median follow-up of 53 months (range, 1-92 months), patients in the standard arm had a significantly better PFS than those in the experimental arm (3-year PFS 86%  v  72%;  P  < .001). The better PFS of the standard versus experimental arm was confirmed in all the study subgroups except non-CMR patients (n = 65;  P  = .274). The 3-year overall survival was 98% (95% CI, 96 to 99) and 97% (95% CI, 95 to 99) in the reference and experimental arms, respectively ( P  = .238).
CONCLUSION


A metabolic and molecular response-adapted therapy as assessed in the FOLL12 study was associated with significantly inferior PFS compared with 2-year RM. The better efficacy of standard RM was confirmed in the subgroup analysis and particularly for patients achieving both CMR and MRD-negative.",2022,The better efficacy of standard RM was confirmed in the subgroup analysis and particularly for patients achieving both CMR and MRD-negative.,"['patients with follicular lymphoma who responded to induction immunochemotherapy', 'We randomly assigned treatment-naïve, advanced-stage, high-tumor burden follicular lymphoma patients to receive', '807 patients were randomly assigned', 'Patients With Advanced-Stage Follicular Lymphoma']","['standard RM or a response-adapted postinduction approach', 'standard RM', 'rituximab', 'ibritumomab tiuxetan followed by standard RM', 'rituximab maintenance (RM) with a response-adapted postinduction approach']","['PFS', '3-year overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0877880', 'cui_str': 'ibritumomab tiuxetan'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",807.0,0.0634749,The better efficacy of standard RM was confirmed in the subgroup analysis and particularly for patients achieving both CMR and MRD-negative.,"[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Luminari', 'Affiliation': 'Surgical, Medical and Dental Department of Morphological Sciences Related to Transplant, Oncology and Regenerative Medicine, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Manni', 'Affiliation': 'Surgical, Medical and Dental Department of Morphological Sciences Related to Transplant, Oncology and Regenerative Medicine, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Galimberti', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Annibale', 'Initials': 'A', 'LastName': 'Versari', 'Affiliation': 'Nuclear Medicine Division, Azienda USL IRCCS of Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tucci', 'Affiliation': 'ASST Spedali Civili di Brescia-Ematologia, Brescia, Italy.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Boccomini', 'Affiliation': 'A.O.U. Città della Salute e della Scienza di Torino-SC Ematologia, Torino, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Farina', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Division of Hematology, Milano, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Olivieri', 'Affiliation': 'Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), SOC Clinica Ematologica, Udine, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Marcheselli', 'Affiliation': 'Fondazione Italiana Linfomi Onlus, Modena, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Guerra', 'Affiliation': 'School of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Ferrero', 'Affiliation': 'A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria, Torino, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Arcaini', 'Affiliation': 'IRCCS Policlinico S. Matteo di Pavia, Div di Ematologia, Pavia, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Cavallo', 'Affiliation': 'A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria, Torino, Italy.'}, {'ForeName': 'Sofya', 'Initials': 'S', 'LastName': 'Kovalchuk', 'Affiliation': 'Azienda Ospedaliera Universitaria Careggi, Unità funzionale di Ematologia, Firenze, Italy.'}, {'ForeName': 'Tetiana', 'Initials': 'T', 'LastName': 'Skrypets', 'Affiliation': 'Surgical, Medical and Dental Department of Morphological Sciences Related to Transplant, Oncology and Regenerative Medicine, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Del Giudice', 'Affiliation': 'Policlinico Umberto I, Università ""La Sapienza,"" Istituto Ematologia, Dipartimento di Medicina Traslazionale e di Precisione, Roma, Italy.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Chauvie', 'Affiliation': 'Medical Physics Division, Santa Croce e Carle Hospital, Cuneo, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Patti', 'Affiliation': 'A.O. Ospedali Riuniti Villa Sofia-Cervello, Div di Ematologia, Palermo, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Stelitano', 'Affiliation': 'Grande Ospedale Metropolitano Bianchi Melacrino Morelli-Ematologia, Reggio Calabria, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ricci', 'Affiliation': 'Istituto Clinico Humanitas, U.O. Ematologia, Rozzano, Italy.'}, {'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'Pinto', 'Affiliation': 'Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale, UOC Ematologia Oncologica, Napoli, Italy.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Margiotta Casaluci', 'Affiliation': 'AOU Maggiore della Carità di Novara, SCDU Ematologia, Novara, Italy.'}, {'ForeName': 'Vittorio R', 'Initials': 'VR', 'LastName': 'Zilioli', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia, Milano, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Merli', 'Affiliation': 'Ospedale degli Infermi di Rimini, U.O. di Ematologia, Rimini, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ladetto', 'Affiliation': 'Dipartimento di Medicina Traslazionale Università del Piemonte Orientale, Alessandria, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bolis', 'Affiliation': 'SC di Ematologia, ASST MONZA, Monza, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Pavone', 'Affiliation': 'A.O. C. Panico, U.O.C Ematologia e Trapianto, Tricase, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Chiarenza', 'Affiliation': 'A.O.O. Policlinico ""G. Rodolico-S. Marco,"" U.O.C. Ematologia, Catania, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Arcari', 'Affiliation': 'Ospedale Guglielmo da Saliceto, U.O.Ematologia, Piacenza, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Anastasia', 'Affiliation': 'ASST Spedali Civili di Brescia-Ematologia, Brescia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Dondi', 'Affiliation': 'Fondazione Italiana Linfomi Onlus, Modena, Italy.'}, {'ForeName': 'Donato', 'Initials': 'D', 'LastName': 'Mannina', 'Affiliation': 'Azienda Ospedaliera Papardo-UOC di Ematologia, Messina, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Federico', 'Affiliation': 'Surgical, Medical and Dental Department of Morphological Sciences Related to Transplant, Oncology and Regenerative Medicine, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.01234']
1144,34713704,Implications of Myocardial Infarction on Management and Outcome in Cardiogenic Shock.,"Background The randomized DOREMI (Dobutamine Compared to Milrinone) clinical trial evaluated the efficacy and safety of milrinone and dobutamine in patients with cardiogenic shock. Whether the results remain consistent when stratified by acute myocardial infarction remains unknown. In this substudy, we sought to evaluate differences in clinical management and outcomes of acute myocardial infarction complicated by cardiogenic shock (AMICS) versus non-AMICS. Methods and Results Patients in cardiogenic shock (n=192) were randomized 1:1 to dobutamine or milrinone. The primary composite end point in this subgroup analysis was all-cause in-hospital mortality, cardiac arrest, non-fatal myocardial infarction, cerebrovascular accident, the need for mechanical circulatory support, or initiation of renal replacement therapy (RRT) at 30-days. Outcomes were evaluated in patients with (n=65) and without (n=127) AMICS. The primary composite end point was significantly higher in AMICS versus non-AMICS (hazard ratio [HR], 2.21; 95% CI, 1.47-3.30;  P =0.0001). The primary end point was driven by increased rates of all-cause mortality, mechanical circulatory support, and RRT. No differences in other secondary outcomes including cardiac arrest or cerebrovascular accident were observed. AMICS remained associated with the primary composite outcome, 30-day mortality, and RRT after adjustment for age, sex, procedural contrast use, multivessel disease, and inotrope type. Conclusions AMI was associated with increased rates of adverse clinical outcomes in cardiogenic shock along with increased rates of mortality and initiation of mechanical circulatory support and RRT. Contrast administration during revascularization likely contributes to increased rates of RRT. Heterogeneity of outcomes in AMICS versus non-AMICS highlights the need to study interventions in specific subgroups of cardiogenic shock. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03207165.",2021,"AMICS remained associated with the primary composite outcome, 30-day mortality, and RRT after adjustment for age, sex, procedural contrast use, multivessel disease, and inotrope type.","['Patients in cardiogenic shock (n=192', 'Cardiogenic Shock', 'patients with (n=65) and without (n=127) AMICS', 'patients with cardiogenic shock']","['AMICS versus non-AMICS', 'milrinone and dobutamine', 'cardiogenic shock (AMICS) versus non-AMICS', 'dobutamine or milrinone', 'Dobutamine', 'Milrinone']","['AMICS versus non-AMICS', 'rates of RRT', 'cause in-hospital mortality, cardiac arrest, non-fatal myocardial infarction, cerebrovascular accident, the need for mechanical circulatory support, or initiation of renal replacement therapy (RRT) at 30-days', 'cardiac arrest or cerebrovascular accident', 'rates of all-cause mortality, mechanical circulatory support, and RRT', 'efficacy and safety', '30-day mortality, and RRT after adjustment for age, sex, procedural contrast use, multivessel disease, and inotrope type']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}]","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0128513', 'cui_str': 'Milrinone'}, {'cui': 'C0012963', 'cui_str': 'Dobutamine'}]","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0449900', 'cui_str': 'Contrast used'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",192.0,0.345911,"AMICS remained associated with the primary composite outcome, 30-day mortality, and RRT after adjustment for age, sex, procedural contrast use, multivessel disease, and inotrope type.","[{'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Jung', 'Affiliation': 'CAPITAL Research Group Division of Cardiology University of Ottawa Heart Institute Ottawa Ontario Canada.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Di Santo', 'Affiliation': 'CAPITAL Research Group Division of Cardiology University of Ottawa Heart Institute Ottawa Ontario Canada.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Mathew', 'Affiliation': 'CAPITAL Research Group Division of Cardiology University of Ottawa Heart Institute Ottawa Ontario Canada.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Abdel-Razek', 'Affiliation': 'CAPITAL Research Group Division of Cardiology University of Ottawa Heart Institute Ottawa Ontario Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Parlow', 'Affiliation': 'CAPITAL Research Group Division of Cardiology University of Ottawa Heart Institute Ottawa Ontario Canada.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Simard', 'Affiliation': 'CAPITAL Research Group Division of Cardiology University of Ottawa Heart Institute Ottawa Ontario Canada.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Marbach', 'Affiliation': 'CAPITAL Research Group Division of Cardiology University of Ottawa Heart Institute Ottawa Ontario Canada.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Gillmore', 'Affiliation': 'Faculty of Medicine University of Ottawa Ontario Canada.'}, {'ForeName': 'Brennan', 'Initials': 'B', 'LastName': 'Mao', 'Affiliation': 'Faculty of Medicine University of Ottawa Ontario Canada.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Bernick', 'Affiliation': 'Cardiovascular Research Methods Centre University of Ottawa Heart Institute Ottawa Canada.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Theriault-Lauzier', 'Affiliation': 'CAPITAL Research Group Division of Cardiology University of Ottawa Heart Institute Ottawa Ontario Canada.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Fu', 'Affiliation': 'CAPITAL Research Group Division of Cardiology University of Ottawa Heart Institute Ottawa Ontario Canada.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lau', 'Affiliation': 'CAPITAL Research Group Division of Cardiology University of Ottawa Heart Institute Ottawa Ontario Canada.'}, {'ForeName': 'Pouya', 'Initials': 'P', 'LastName': 'Motazedian', 'Affiliation': 'University of Calgary Alberta Canada.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Russo', 'Affiliation': 'CAPITAL Research Group Division of Cardiology University of Ottawa Heart Institute Ottawa Ontario Canada.'}, {'ForeName': 'Marino', 'Initials': 'M', 'LastName': 'Labinaz', 'Affiliation': 'CAPITAL Research Group Division of Cardiology University of Ottawa Heart Institute Ottawa Ontario Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hibbert', 'Affiliation': 'CAPITAL Research Group Division of Cardiology University of Ottawa Heart Institute Ottawa Ontario Canada.'}]",Journal of the American Heart Association,['10.1161/JAHA.121.021570']
1145,34697975,Validation of a visual analog scale for assessing cough severity in patients with chronic cough.,"INTRODUCTION


Patients with chronic cough experience considerable burden. The cough severity visual analog scale (VAS) records patients' assessment of cough severity on a 100-mm linear scale ranging from ""no cough"" (0 mm) to ""worst cough"" (100 mm). Although cough severity scales are widely used in clinical practice and research, their use in patients with refractory or unexplained chronic cough has not been formally validated.
METHODS


This analysis includes data from a phase 2b randomized controlled trial of the P2X3-receptor antagonist gefapixant for treatment of refractory or unexplained chronic cough (NCT02612610). Cough severity VAS scores were assessed at baseline and Weeks 4, 8, and 12. The cough severity VAS was validated using several outcomes, including the Cough Severity Diary (CSD), Leicester Cough Questionnaire (LCQ), patient global impression of change (PGIC) scale, and objective cough frequency. Validation metrics included test-retest reliability, convergent and known-groups validity, responsiveness, and score interpretation (i.e., clinically meaningful change threshold).
RESULTS


The analysis included 253 patients (median age, 61.0 years; females, 76%). Test-retest reliability of the cough severity VAS was moderate (intraclass correlation coefficient, 0.51). The cough severity VAS had acceptable convergent validity with other related measures (Pearson  r  of 0.53 and -0.41 for CSD and LCQ total scores, respectively;  p  < 0.0001 for each). Known-groups validity was supported by significant differences in mean cough severity VAS scores across severity groups defined using CSD, LCQ, and cough frequency tertiles. A large effect size was observed in patients with the greatest improvements in PGIC (Cohen  d  = -1.8). A ⩾ 30-mm reduction in the cough severity VAS was estimated as a clinically meaningful change threshold for clinical trials in chronic cough.
CONCLUSIONS


The cough severity VAS is a valid and responsive measure. A cough severity VAS reduction of ⩾ 30 mm can discriminate clinically meaningful changes in chronic cough severity in clinical studies.",2021,A large effect size was observed in patients with the greatest improvements in PGIC (Cohen  d  = -1.8).,"['patients with chronic cough', 'patients with refractory or unexplained chronic cough', '253 patients (median age, 61.0\u2009years; females, 76']","['P2X3-receptor antagonist gefapixant', 'visual analog scale']","['cough severity VAS', 'test-retest reliability, convergent and known-groups validity, responsiveness, and score interpretation (i.e., clinically meaningful change threshold', 'Cough Severity Diary (CSD), Leicester Cough Questionnaire (LCQ), patient global impression of change (PGIC) scale, and objective cough frequency', 'mean cough severity VAS scores', 'cough severity visual analog scale (VAS', 'Cough severity VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4552485', 'cui_str': 'Unexplained chronic cough'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0382265', 'cui_str': 'P2X3 Purinoceptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",253.0,0.081595,A large effect size was observed in patients with the greatest improvements in PGIC (Cohen  d  = -1.8).,"[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Martin Nguyen', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Bacci', 'Affiliation': 'Evidera Inc., Bethesda, MD, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Vernon', 'Affiliation': 'Evidera Inc., Bethesda, MD, USA.'}, {'ForeName': 'Surinder S', 'Initials': 'SS', 'LastName': 'Birring', 'Affiliation': ""Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Carmen La', 'Initials': 'C', 'LastName': 'Rosa', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Muccino', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Schelfhout', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.'}]",Therapeutic advances in respiratory disease,['10.1177/17534666211049743']
1146,34716211,Traveling Across Time Zones With Type 1 Diabetes: A Pilot Study Comparing Insulin Degludec With Insulin Glargine U100.,"OBJECTIVE


For people with type 1 diabetes, there are limited evidence-based resources to support self-management when traveling across multiple time zones. Here, we compared glycemic control on insulin degludec versus glargine U100 as the basal insulin for adults using multiple daily injections (MDI) while traveling across multiple time zones.
RESEARCH DESIGN AND METHODS


This randomized crossover pilot study compared insulin degludec versus glargine U100 for adults with type 1 diabetes using MDI insulin during long-haul travel to and from Hawaii to New York. Insulin degludec was administered daily at the same time regardless of time zone, and glargine was administered per travel algorithm. Primary end point was the percentage of time in range (TIR) between 70 and 140 mg/dL during the initial 24 h after each direction of travel. Secondary end points included standard continuous glucose monitoring metrics, jet lag, fatigue, and sleep.
RESULTS


The study enrolled 25 participants (56% women, mean ± SD age of 35 ± 14.5 years, HbA1c of 7.4 ± 1.2% [57 ± 13.1 mmol/mol], and diabetes duration of 20.6 ± 15 years). There was no significant difference in glycemic outcomes between the two arms of the study, including TIR, hypoglycemia, or hyperglycemia. Neither group achieved >70% TIR 70-180 mg/dL during travel. Jet lag was greater on glargine U100 in eastward travel but not westward. Fatigue was greater after westward travel on glargine. Sleep was not significantly different between basal insulins.
CONCLUSIONS


In adults with type 1 diabetes using MDI of insulin and traveling across multiple time zones, glycemic outcomes were similar comparing insulin degludec and glargine U100.",2022,"There was no significant difference in glycemic outcomes between the two arms of the study, including TIR, hypoglycemia, or hyperglycemia.","['25 participants (56% women, mean ± SD age of 35 ± 14.5 years, HbA 1c  of 7.4 ± 1.2% [57 ± 13.1 mmol/mol], and diabetes duration of 20.6 ± 15 years', 'people with type 1 diabetes', 'adults with type 1 diabetes using MDI insulin during long-haul travel to and from Hawaii to New York']","['insulin degludec versus glargine U100', 'glargine', 'Insulin Degludec With Insulin Glargine U100']","['TIR, hypoglycemia, or hyperglycemia', 'Sleep', 'glycemic outcomes', 'percentage of time in range (TIR', 'Fatigue', 'standard continuous glucose monitoring metrics, jet lag, fatigue, and sleep']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0018619', 'cui_str': 'Hawaii state'}, {'cui': 'C0027976', 'cui_str': 'New York'}]","[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0231311', 'cui_str': 'Jet lag'}]",25.0,0.0585937,"There was no significant difference in glycemic outcomes between the two arms of the study, including TIR, hypoglycemia, or hyperglycemia.","[{'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Bevier', 'Affiliation': '1Sansum Diabetes Research Institute, Santa Barbara, CA.'}, {'ForeName': 'Kristin N', 'Initials': 'KN', 'LastName': 'Castorino', 'Affiliation': '1Sansum Diabetes Research Institute, Santa Barbara, CA.'}, {'ForeName': 'Ceara', 'Initials': 'C', 'LastName': 'Axelrod', 'Affiliation': '1Sansum Diabetes Research Institute, Santa Barbara, CA.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Haroush', 'Affiliation': '1Sansum Diabetes Research Institute, Santa Barbara, CA.'}, {'ForeName': 'Christian C', 'Initials': 'CC', 'LastName': 'Farfan', 'Affiliation': '1Sansum Diabetes Research Institute, Santa Barbara, CA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Shelton', 'Affiliation': '1Sansum Diabetes Research Institute, Santa Barbara, CA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Nelson', 'Affiliation': '1Sansum Diabetes Research Institute, Santa Barbara, CA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Spink', 'Affiliation': '1Sansum Diabetes Research Institute, Santa Barbara, CA.'}, {'ForeName': 'Hanqing', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': '2Abbott Diabetes Care, Alameda, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kerr', 'Affiliation': '1Sansum Diabetes Research Institute, Santa Barbara, CA.'}]",Diabetes care,['10.2337/dc21-1524']
1147,34716636,The effect of Neurolinguistic Programming practices on organizational citizenship behaviour of nurses: A randomized controlled study.,"AIM


The aim of this study is to evaluate the effect of Neurolinguistic Programming practices on organizational citizenship behavior in nursing.
BACKGROUND


Neurolinguistic Programming practices are used for different purposes in many areas, and they can also be used to contribute to the acquisition of organizational citizenship behaviour.
METHODS


The research is a randomized controlled trial. The sample of the study consisted of 180 nurses. The data of the study were collected through structured face-to-face interviews conducted with the nurses in the sample group, Neurolinguistic Programming training group, standard training and control groups between January and April 2020 after Neurolinguistic Programming training was received by the researcher. The Chi-squared test and the analysis of variance (ANOVA) were used to analyze the collected data.
RESULTS


A statistically significant difference was found in the total score of the organizational citizenship behaviour in the Neurolinguistic Programming training group compared with the standard training group and the control group (p < .05).
CONCLUSIONS


The use of Neurolinguistic Programming practices can be an effective method for nurses to gain organizational citizenship behaviour. Neurolinguistic Programming practices can be used to achieve the desired goals, especially for the acquisition of informing and participation, tolerance and conscientiousness behaviours.
IMPLICATIONS FOR NURSING MANAGEMENT


Organizational citizenship behaviour exhibited by employees is very important for organisations. With this behaviour, nurses can improve all processes, from the quality of care services they provide to patients, to satisfaction. Findings of this study may be used to increase work satisfaction of nurses and to improve the quality of services received by patients.",2022,"A statistically significant difference was found in the total score of the organizational citizenship behaviour in the Neuro Linguistic Programming training group compared to the standard training group and the control group (p<0.05).
","['180 nurses', 'Nurses']","['Neurolinguistic Programming practices', 'Neuro Linguistic Programming training group, standard training and control groups between January and April 2020 after Neuro Linguistic Programming training', 'Neuro Linguistic Programming Practices', 'Neuro Linguistic Programming practices']",['total score of the organizational citizenship behaviour'],"[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0683473', 'cui_str': 'Neuro-linguistic Programming'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.017215,"A statistically significant difference was found in the total score of the organizational citizenship behaviour in the Neuro Linguistic Programming training group compared to the standard training group and the control group (p<0.05).
","[{'ForeName': 'Yasin', 'Initials': 'Y', 'LastName': 'Cetin', 'Affiliation': 'Faculty of Health Sciences, Department of Nursing Management, Adiyaman Univeristy, Adiyaman, Turkey.'}, {'ForeName': 'Emriye Hilal', 'Initials': 'EH', 'LastName': 'Yayan', 'Affiliation': 'Faculty of Nursing, Department of Child Health and Diseases Nursing, Inönü University, Malatya, Turkey.'}]",Journal of nursing management,['10.1111/jonm.13502']
1148,34702443,Short-Term Hypocalcemia Prophylaxis With Calcitriol Before Thyroidectomy.,"BACKGROUND


Total thyroidectomy is the most common surgical treatment of thyroid diseases, and postoperative hypocalcemia is its most common complication. Hypocalcemia prolongs the patient's hospital stay and impairs his or her quality of life. Although a low vitamin D level is a recognized risk factor, the utility of preoperative vitamin D administration to prevent postoperative hypocalcemia is unclear. In this trial, therefore, we studied the effect of giving vitamin D before total thyroidectomy.
METHODS


In a multicenter, randomized, minimally interventional trial (registration number: DRKS 00005615), patients about to undergo total thyroidectomy were randomized either to an intervention group that received 0.5 μg of calcitriol per os twice daily for three days up to the day immediately before surgery, or to a control group that did not (no placebo was given). The primary endpoint was the absence of hypocalcemia (serum calcium <2.1 mmol/L) in the postoperative course.
RESULTS


Of the 287 patients recruited in six hospitals over the period 23 July 2014 to 20 March 2017, 246 were included in the final analysis. The intervention and control groups did not differ significantly with respect to the rate of postoperative hypocalcemia (29.2% and 33.6%, respectively; p = 0.546, power 8.8%). The duration of postoperative hypocalcemia was, however, shorter in the intervention group (3.5 vs. 7 days; p = 0.016, power 68%). The rates of hypocalcemia in the individual trial locations varied widely, ranging from 13.9% to 71.4%.
CONCLUSION


Short-term administration of calcitriol did not affect the rate of occurrence of hypocalcemia after thyroidectomy, but did shorten its duration. The rate of postoperative hypocalcemia varied widely across hospitals, probably because of differences in surgical technique.",2021,"Short-term administration of calcitriol did not affect the rate of occurrence of hypocalcemia after thyroidectomy, but did shorten its duration.","['patients about to undergo total thyroidectomy', '287 patients recruited in six hospitals over the period 23 July 2014 to 20 March 2017']","['giving vitamin D before total thyroidectomy', 'control group that did not (no placebo', 'Calcitriol', 'calcitriol', 'Short-Term Hypocalcemia Prophylaxis']","['rate of occurrence of hypocalcemia', 'absence of hypocalcemia (serum calcium', 'rate of postoperative hypocalcemia', 'rates of hypocalcemia', 'duration of postoperative hypocalcemia', ""Hypocalcemia prolongs the patient's hospital stay and impairs his or her quality of life""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006674', 'cui_str': 'Calcitriol'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",287.0,0.0963077,"Short-term administration of calcitriol did not affect the rate of occurrence of hypocalcemia after thyroidectomy, but did shorten its duration.","[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Sonnenberg', 'Affiliation': 'Department of General, Visceral and Thoracic Surgery, Klinikum Hanau GmbH; Department of Endocrine Surgery, Diakonie Klinikum Stuttgart; Department of General and Visceral Surgery, Asklepios Klinik Seligenstadt; Department of Endocrine Surgery, Bürgerhospital Frankfurt/Main; Department of General, Visceral, and Vascular Surgery, KRH Klinikum Robert Koch Gehrden; Department of General and Visceral Surgery, Frankfurt University Hospital and Clinics; Department of Visceral, Thoracic and Vascular Surgery, Philipps-University of Marburg.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Scheunchen', 'Affiliation': ''}, {'ForeName': 'Constantin Aurel', 'Initials': 'CA', 'LastName': 'Smaxwil', 'Affiliation': ''}, {'ForeName': 'Heimo', 'Initials': 'H', 'LastName': 'Weih', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vorländer', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Langer', 'Affiliation': ''}, {'ForeName': 'Aaltje', 'Initials': 'A', 'LastName': 'Ostermann', 'Affiliation': ''}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Holzer', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Zielke', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.m2021.0351']
1149,34708423,Population Pharmacokinetics and Exposure-Response Modeling of Daratumumab Subcutaneous Administration in Patients With Light-Chain Amyloidosis.,"The purpose of this study is to characterize the population pharmacokinetics (popPK) of subcutaneous (SC) daratumumab in combination with bortezomib, cyclophosphamide, and dexamethasone and explore the relationship between daratumumab systemic exposure and selected efficacy and safety end points in patients with newly diagnosed systemic amyloid light-chain amyloidosis. The popPK analysis included pharmacokinetic and immunogenicity data from patients receiving daratumumab SC in combination with bortezomib, cyclophosphamide, and dexamethasone in the ANDROMEDA study (AMY3001; safety run-in, n = 28; randomized phase, n = 183). Nonlinear mixed-effects modeling was used to characterize the popPK and quantify the impact of potential covariates. The exposure-response (E-R) analysis included data from all patients in the randomized phase of ANDROMEDA (n = 388). Logistic regression and survival analysis were used to evaluate the relationships between daratumumab systemic exposure and efficacy end points. The E-R analysis on safety was conducted using quartile comparison and logistic regression analysis. The observed concentration-time data of daratumumab SC were well described by a 1-compartment popPK model with first-order absorption and parallel linear and nonlinear Michaelis-Menten elimination pathways. None of the investigated covariates were determined to be clinically meaningful. Daratumumab systemic exposure was generally similar across subgroups that achieved different levels of hematologic response, and there was no apparent relationship between daratumumab systemic exposure and the investigated safety end points. In conclusion, the popPK and E-R analyses supported the selected 1800-mg flat dose of daratumumab SC in combination with the bortezomib, cyclophosphamide, and dexamethasone regimen for the treatment of light-chain amyloidosis. No dose adjustment was recommended for investigated covariates.",2021,"Daratumumab systemic exposure was generally similar across subgroups that achieved different levels of hematologic response, and there was no apparent relationship between daratumumab systemic exposure and the investigated safety endpoints.","['light-chain amyloidosis', 'patients receiving daratumumab SC in combination with', 'Patients With Light-chain Amyloidosis', 'patients with newly diagnosed systemic light-chain (AL) amyloidosis']","['Daratumumab Subcutaneous Administration', 'bortezomib, cyclophosphamide, and dexamethasone']",['hematologic response'],"[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0018943', 'cui_str': 'Hematology'}]",28.0,0.0955055,"Daratumumab systemic exposure was generally similar across subgroups that achieved different levels of hematologic response, and there was no apparent relationship between daratumumab systemic exposure and the investigated safety endpoints.","[{'ForeName': 'Man Melody', 'Initials': 'MM', 'LastName': 'Luo', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Peijuan Penny', 'Initials': 'PP', 'LastName': 'Zhu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Nnane', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Merlini', 'Affiliation': 'Amyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, and Department of Molecular Medicine, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Raymond L', 'Initials': 'RL', 'LastName': 'Comenzo', 'Affiliation': 'Division of Hematology/Oncology, John C. Davis Myeloma and Amyloid Program, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Kastritis', 'Affiliation': 'Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.'}, {'ForeName': 'Ashutosh D', 'Initials': 'AD', 'LastName': 'Wechalekar', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Brendan M', 'Initials': 'BM', 'LastName': 'Weiss', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'NamPhuong', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'Janssen Research & Development, Los Angeles, California, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vermeulen', 'Affiliation': 'Janssen Research & Development, Leiden, The Netherlands.'}, {'ForeName': 'Amarnath', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Yu-Nien', 'Initials': 'YN', 'LastName': 'Sun', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Honghui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1994']
1150,34710363,"Supervised versus unsupervised primaquine radical cure for the treatment of falciparum and vivax malaria in Papua, Indonesia: a cluster-randomised, controlled, open-label superiority trial.","BACKGROUND


There is a high risk of Plasmodium vivax recurrence in patients treated for Plasmodium falciparum malaria in co-endemic areas. Primaquine radical cure has the potential to reduce P vivax recurrences in patients presenting with P falciparum as well as P vivax malaria but is undermined by poor adherence to the currently recommended 14-day regimen. We aimed to assess the efficacy and safety of supervised versus unsupervised primaquine radical cure in patients presenting with uncomplicated malaria.
METHODS


We did a cluster-randomised, controlled, open-label superiority trial in Papua, Indonesia. 21 clusters of village health posts, matched by annual parasite index, were randomly assigned (1:1) to treat patients (age >12 months and body weight >5 kg) presenting with confirmed uncomplicated P falciparum or P vivax malaria with oral dihydroartemisinin-piperaquine plus either a supervised or unsupervised 14-day course of oral primaquine (0·5 mg/kg per day). Patients in the supervised group were supervised taking their primaquine dose on alternate days. Patients were followed-up for 6 months and those who presented again with malaria were retreated with the same drug regimen. Masking was not possible due to the nature of the study. The primary outcome was the incidence risk of P vivax malaria over 6 months, assessed in the modified intention-to-treat population (all patients who were assigned to a treatment group, excluding patients who were lost to follow-up after their first visit). This trial is now complete, and is registered with ClinicalTrials.gov, NCT02787070.
FINDINGS


Between Sept 14, 2016, and July 31, 2018, 436 patients were screened for eligibility and 419 were enrolled; 223 (53%) patients in 11 clusters were assigned to supervised primaquine treatment and 196 (47%) in ten clusters to unsupervised primaquine treatment. 161 (72%) of 223 patients in the supervised group and 151 (77%) of 196 in the unsupervised group completed 6 months of follow-up. At 6 months, the incidence risk of P vivax recurrence in the supervised group was 29·7% (95% CI 16·4-49·9) versus 55·8% (32·3-81·8) in the unsupervised group (hazard ratio 0·23 [95% CI 0·07-0·76]; p=0·016). The incidence rate for P vivax recurrence was 539 (95% CI 390-747) infections per 1000 person-years in the supervised group versus 859 (673-1096) in the unsupervised group (incidence rate ratio 0·63 [95% CI 0·42-0·94]; p=0·025). The corresponding rates in the 224 patients who presented with P falciparum malaria were 346 (95% CI 213-563) and 660 (446-977; incidence rate ratio 0·52 [95% CI 0·28-0·98]; p=0·043). Seven serious adverse events were reported (three in the supervised group, four in the unsupervised group), none of which were deemed treatment-related, and there were no deaths.
INTERPRETATION


In this area of moderate malaria transmission, supervision of primaquine radical cure treatment reduced the risk of P vivax recurrence. This finding was apparent for patients presenting with either P falciparum or P vivax malaria. Further studies are warranted to investigate the safety and efficacy of radical cure for patients presenting with uncomplicated falciparum malaria in other co-endemic areas.
FUNDING


The Bill & Melinda Gates Foundation, Wellcome Trust, and Department of Foreign Affairs and Trade of the Australian Government.
TRANSLATION


For the Indonesian translation of the abstract see Supplementary Materials section.",2022,"In this area of moderate malaria transmission, supervision of primaquine radical cure treatment reduced the risk of P vivax recurrence.","['21 clusters of village health posts, matched by annual parasite index, were randomly assigned (1:1) to treat patients (age >12 months and body weight >5 kg) presenting with confirmed uncomplicated P falciparum or P vivax malaria with', 'Between Sept 14, 2016, and July 31, 2018', '436 patients were screened for eligibility and 419 were enrolled; 223 (53%) patients in 11 clusters', 'patients presenting with uncomplicated malaria', 'patients treated for Plasmodium falciparum malaria in co-endemic areas', 'patients presenting with either P falciparum or P vivax malaria', 'patients presenting with uncomplicated falciparum malaria in other co-endemic areas']","['primaquine', 'supervised versus unsupervised primaquine radical cure', 'Primaquine radical', 'oral dihydroartemisinin-piperaquine plus either a supervised or unsupervised 14-day course of oral primaquine', 'Supervised versus unsupervised primaquine radical cure', 'primaquine treatment']","['incidence rate for P vivax recurrence', 'P vivax recurrences', 'incidence rate ratio 0·52', 'risk of P vivax recurrence', 'incidence risk of P vivax recurrence', 'efficacy and safety', 'Seven serious adverse events', 'incidence risk of P vivax malaria']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0858318', 'cui_str': 'Plasmodium falciparum infection'}, {'cui': 'C0858321', 'cui_str': 'Plasmodium vivax infection'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0024535', 'cui_str': 'Falciparum malaria'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0858321', 'cui_str': 'Plasmodium vivax infection'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]",436.0,0.191595,"In this area of moderate malaria transmission, supervision of primaquine radical cure treatment reduced the risk of P vivax recurrence.","[{'ForeName': 'Jeanne Rini', 'Initials': 'JR', 'LastName': 'Poespoprodjo', 'Affiliation': 'Centre for Child Health and Department of Child Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia; Timika Malaria Research Facility, Papuan Health and Community Development Foundation, Timika, Papua, Indonesia; Mimika District Hospital and District Health Authority, Timika, Papua, Indonesia. Electronic address: didot2266@yahoo.com.'}, {'ForeName': 'Faustina Helena', 'Initials': 'FH', 'LastName': 'Burdam', 'Affiliation': 'Timika Malaria Research Facility, Papuan Health and Community Development Foundation, Timika, Papua, Indonesia; Mimika District Hospital and District Health Authority, Timika, Papua, Indonesia.'}, {'ForeName': 'Freis', 'Initials': 'F', 'LastName': 'Candrawati', 'Affiliation': 'Timika Malaria Research Facility, Papuan Health and Community Development Foundation, Timika, Papua, Indonesia.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Ley', 'Affiliation': 'Global Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia.'}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Meagher', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, VIC, Australia; Victorian Infectious Diseases Reference Laboratory Epidemiology Unit at the Peter Doherty Institute for Infection and Immunity, University of Melbourne and Royal Melbourne Hospital, VIC, Australia.'}, {'ForeName': 'Enny', 'Initials': 'E', 'LastName': 'Kenangalem', 'Affiliation': 'Timika Malaria Research Facility, Papuan Health and Community Development Foundation, Timika, Papua, Indonesia; Mimika District Hospital and District Health Authority, Timika, Papua, Indonesia.'}, {'ForeName': 'Ratni', 'Initials': 'R', 'LastName': 'Indrawanti', 'Affiliation': 'Centre for Child Health and Department of Child Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Leily', 'Initials': 'L', 'LastName': 'Trianty', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Kamala', 'Initials': 'K', 'LastName': 'Thriemer', 'Affiliation': 'Global Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Price', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, VIC, Australia; Victorian Infectious Diseases Reference Laboratory Epidemiology Unit at the Peter Doherty Institute for Infection and Immunity, University of Melbourne and Royal Melbourne Hospital, VIC, Australia.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Simpson', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, VIC, Australia.'}, {'ForeName': 'Ric N', 'Initials': 'RN', 'LastName': 'Price', 'Affiliation': 'Global Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia; Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK; Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(21)00358-3']
1151,34711126,"Safety and tolerability of linagliptin in Asians with type 2 diabetes: a pooled analysis of 4457 patients from 21 randomized, double-blind, placebo-controlled clinical trials.","BACKGROUND


Safety and tolerability of glucose-lowering drugs is a key consideration for use in type 2 diabetes (T2D). We evaluated the safety and tolerability of the dipeptidyl peptidase-4 inhibitor linagliptin in Asian patients with T2D.
RESEARCH DESIGN AND METHODS


This was a post-hoc, descriptive pooled analysis of 21 randomized, double-blind, placebo-controlled clinical trials of linagliptin in T2D patients lasting ≤52 weeks. We evaluated adverse events (AEs) and laboratory parameters in Asian participants living in Asia, both overall and in the East Asian subgroup.
RESULTS


This analysis included 4457 Asian patients overall (2712 receiving linagliptin; 1745 receiving placebo) and 3057 (68.6%) East Asians. AEs were reported in 1510 (55.7%) Asian patients receiving linagliptin and 1032 (59.1%) receiving placebo but were considered drug-related in only 13.0% of each group. Serious AEs occurred in 109 (4.0%) linagliptin patients and 90 (5.2%) placebo patients. The most common AEs were nasopharyngitis (6.4% linagliptin, 7.3% placebo), upper respiratory tract infection (5.7% linagliptin, 6.5% placebo), and hypoglycemia (7.3% linagliptin, 6.3% placebo). One linagliptin patient had pancreatitis; none had bullous pemphigoid. No clinically relevant mean changes in laboratory parameters occurred. These findings were consistent in East Asians.
CONCLUSIONS


Linagliptin is well tolerated in Asian T2D patients, including East Asians, with low risk for AEs.",2022,AEs were reported in 1510 (55.7%),"['Asian T2D patients, including East Asians, with low risk for AEs', 'Asian patients receiving', '4457 Asian patients overall (2712 receiving linagliptin; 1745 receiving placebo) and 3057 (68.6%) East Asians', 'Asian participants living in Asia, both overall and in the East Asian subgroup', '4457 patients from 21 randomized', 'Asians with type 2 diabetes', 'type 2 diabetes (T2D', 'T2D patients lasting ≤52 weeks', 'Asian patients with T2D']","['glucose-lowering drugs', 'Linagliptin', 'linagliptin', 'dipeptidyl peptidase-4 inhibitor linagliptin', 'placebo']","['adverse events (AEs) and laboratory parameters', 'Serious AEs', 'hypoglycemia', 'upper respiratory tract infection', 'Safety and tolerability', 'nasopharyngitis', 'safety and tolerability']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}]",4457.0,0.559004,AEs were reported in 1510 (55.7%),"[{'ForeName': 'Keizo', 'Initials': 'K', 'LastName': 'Kanasaki', 'Affiliation': 'Department of Internal Medicine 1, Faculty of Medicine, Shimane University, Izumo, Japan.'}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Fumiko', 'Initials': 'F', 'LastName': 'Yamamoto', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Schepers', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Sani Simões', 'Affiliation': 'Global Patient Safety & Pharmacovigilance, Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yabe', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism and Department of Rheumatology and Clinical Immunology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.""}]",Expert opinion on drug safety,['10.1080/14740338.2022.1999409']
1152,34714398,White-opaque flowable composite liner as a depth marker in composite restorations prevents tooth substance loss in filling removal: a randomized double-blinded in vitro study.,"OBJECTIVES


Removal of esthetic restorations leads to loss of tooth structure and the extent of the loss is difficult to estimate due to exact-shade matching. This randomized double-blinded in vitro study aimed examining the influence of a white-opaque flowable composite depth marker as an optical removal aid for tooth substance preservation and shortened restoration removal time.
MATERIALS AND METHODS


Class II cavities (n = 100) in extracted healthy mandibular molars (n = 50, two runs) were prepared, filled, and the restoration removed. Tooth weight and volume (before and after) and removal time were measured and remnants visually documented. An optimal tooth shade-matched flowable composite liner was used as control.
RESULTS


Tooth structure loss was significantly lower using a white-opaque liner. Mean values for volume/weight loss were 0.037 ± 0.030 g and 0.016 ± 0.005 cm 3  (p < 0.01) for white-opaque liner; 0.067 ± 0.000 g and 0.028 ± 0.003 cm 3  (p < 0.01) for tooth-colored composite. Removal time and number of pulp chamber perforations showed no significant differences (p = 0.80).
CONCLUSIONS


Within the limitations of this randomized double-blinded in vitro study, the use of a white-opaque flowable liner as a depth marker may provide the practitioner a visual aid in the replacement of a composite restoration and may protect against tooth structure loss.
CLINICAL RELEVANCE


When restoration replacement is indicated, removal of esthetic restorations often causes tooth structure loss due to difficult optical color matching. Using a white-opaque flowable liner as a depth marker clinically aids in restoration removal and protects against tooth structure loss.",2022,"Removal time and number of pulp chamber perforations showed no significant differences (p = 0.80).
","['Class II cavities (n\u2009=\u2009100) in extracted healthy mandibular molars (n\u2009=\u200950, two runs']",[],"['Tooth weight and volume (before and after) and removal time', 'Mean values for volume/weight loss', 'tooth substance loss', 'Tooth structure loss', 'Removal time and number of pulp chamber perforations']","[{'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",[],"[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0399400', 'cui_str': 'Tooth surface loss'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034099', 'cui_str': 'Pulp chamber of tooth'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}]",,0.329056,"Removal time and number of pulp chamber perforations showed no significant differences (p = 0.80).
","[{'ForeName': 'Thomas Gerhard', 'Initials': 'TG', 'LastName': 'Wolf', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, School of Dental Medicine, University of Bern, Freiburgstrasse 7, CH-3010, Bern, Switzerland. thomas.wolf@zmk.unibe.ch.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Dekert', 'Affiliation': 'Department of Periodontology and Operative Dentistry, University Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Guglielmo', 'Initials': 'G', 'LastName': 'Campus', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, School of Dental Medicine, University of Bern, Freiburgstrasse 7, CH-3010, Bern, Switzerland.'}, {'ForeName': 'Claus-Peter', 'Initials': 'CP', 'LastName': 'Ernst', 'Affiliation': 'Department of Periodontology and Operative Dentistry, University Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.'}]",Clinical oral investigations,['10.1007/s00784-021-04244-5']
1153,34717820,"Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial.","BACKGROUND


Recent evidence indicates a potential therapeutic role of fluvoxamine for COVID-19. In the TOGETHER trial for acutely symptomatic patients with COVID-19, we aimed to assess the efficacy of fluvoxamine versus placebo in preventing hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to a tertiary hospital due to COVID-19.
METHODS


This placebo-controlled, randomised, adaptive platform trial done among high-risk symptomatic Brazilian adults confirmed positive for SARS-CoV-2 included eligible patients from 11 clinical sites in Brazil with a known risk factor for progression to severe disease. Patients were randomly assigned (1:1) to either fluvoxamine (100 mg twice daily for 10 days) or placebo (or other treatment groups not reported here). The trial team, site staff, and patients were masked to treatment allocation. Our primary outcome was a composite endpoint of hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to tertiary hospital due to COVID-19 up to 28 days post-random assignment on the basis of intention to treat. Modified intention to treat explored patients receiving at least 24 h of treatment before a primary outcome event and per-protocol analysis explored patients with a high level adherence (>80%). We used a Bayesian analytic framework to establish the effects along with probability of success of intervention compared with placebo. The trial is registered at ClinicalTrials.gov (NCT04727424) and is ongoing.
FINDINGS


The study team screened 9803 potential participants for this trial. The trial was initiated on June 2, 2020, with the current protocol reporting randomisation to fluvoxamine from Jan 20 to Aug 5, 2021, when the trial arms were stopped for superiority. 741 patients were allocated to fluvoxamine and 756 to placebo. The average age of participants was 50 years (range 18-102 years); 58% were female. The proportion of patients observed in a COVID-19 emergency setting for more than 6 h or transferred to a teritary hospital due to COVID-19 was lower for the fluvoxamine group compared with placebo (79 [11%] of 741 vs 119 [16%] of 756); relative risk [RR] 0·68; 95% Bayesian credible interval [95% BCI]: 0·52-0·88), with a probability of superiority of 99·8% surpassing the prespecified superiority threshold of 97·6% (risk difference 5·0%). Of the composite primary outcome events, 87% were hospitalisations. Findings for the primary outcome were similar for the modified intention-to-treat analysis (RR 0·69, 95% BCI 0·53-0·90) and larger in the per-protocol analysis (RR 0·34, 95% BCI, 0·21-0·54). There were 17 deaths in the fluvoxamine group and 25 deaths in the placebo group in the primary intention-to-treat analysis (odds ratio [OR] 0·68, 95% CI: 0·36-1·27). There was one death in the fluvoxamine group and 12 in the placebo group for the per-protocol population (OR 0·09; 95% CI 0·01-0·47). We found no significant differences in number of treatment emergent adverse events among patients in the fluvoxamine and placebo groups.
INTERPRETATION


Treatment with fluvoxamine (100 mg twice daily for 10 days) among high-risk outpatients with early diagnosed COVID-19 reduced the need for hospitalisation defined as retention in a COVID-19 emergency setting or transfer to a tertiary hospital.
FUNDING


FastGrants and The Rainwater Charitable Foundation.
TRANSLATION


For the Portuguese translation of the abstract see Supplementary Materials section.",2022,"We found no significant differences in number of treatment emergent adverse events among patients in the fluvoxamine and placebo groups.
","['9803 potential participants for this trial', 'patients with COVID-19', 'high-risk outpatients with early diagnosed COVID-19 reduced the need for hospitalisation defined as retention in a COVID-19 emergency setting or transfer to a tertiary hospital', 'high-risk symptomatic Brazilian adults confirmed positive for SARS-CoV-2 included eligible patients from 11 clinical sites in Brazil with a known risk factor for progression to severe disease', '741 patients', 'The average age of participants was 50 years (range 18-102 years); 58% were female', 'acutely symptomatic patients with COVID-19']","['fluvoxamine versus placebo', 'fluvoxamine', 'placebo']","['composite endpoint of hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to tertiary hospital due to COVID-19 up to 28 days post-random assignment on the basis of intention to treat', 'death', 'modified intention-to-treat analysis', 'teritary hospital due to COVID-19', 'number of treatment emergent adverse events', 'risk of emergency care and hospitalisation']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0085228', 'cui_str': 'Fluvoxamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}]",741.0,0.925821,"We found no significant differences in number of treatment emergent adverse events among patients in the fluvoxamine and placebo groups.
","[{'ForeName': 'Gilmar', 'Initials': 'G', 'LastName': 'Reis', 'Affiliation': 'Research Division, Cardresearch - Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Brazil; Department of Medicine, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Brazil. Electronic address: Brazilgreis@cardresearch.org.'}, {'ForeName': 'Eduardo Augusto', 'Initials': 'EA', 'LastName': 'Dos Santos Moreira-Silva', 'Affiliation': 'Research Division, Cardresearch - Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Brazil; Department of Medicine, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Daniela Carla Medeiros', 'Initials': 'DCM', 'LastName': 'Silva', 'Affiliation': 'Research Division, Cardresearch - Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Brazil; Department of Medicine, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Aline Cruz', 'Initials': 'AC', 'LastName': 'Milagres', 'Affiliation': 'Family Medicine, Mental and Public Health Department, Ouro Preto Federal University, Ouro Preto, Brazil; Public Health Care Division, City of Ibirité, Brazil.'}, {'ForeName': 'Thiago Santiago', 'Initials': 'TS', 'LastName': 'Ferreira', 'Affiliation': 'Research Division, Cardresearch - Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Brazil.'}, {'ForeName': 'Castilho Vitor Quirino', 'Initials': 'CVQ', 'LastName': 'Dos Santos', 'Affiliation': 'Research Division, Cardresearch - Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Brazil; Department of Medicine, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Vitoria Helena', 'Initials': 'VH', 'LastName': 'de Souza Campos', 'Affiliation': 'Research Division, Cardresearch - Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Brazil; Department of Medicine, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Ana Maria Ribeiro', 'Initials': 'AMR', 'LastName': 'Nogueira', 'Affiliation': 'Department of Public Health at UniFipMoc and Family Medicine Fellowship Program, Montes Claros, Brazil.'}, {'ForeName': 'Ana Paula Figueiredo Guimaraes', 'Initials': 'APFG', 'LastName': 'de Almeida', 'Affiliation': 'Department of Public Health at UniFipMoc and Family Medicine Fellowship Program, Montes Claros, Brazil.'}, {'ForeName': 'Eduardo Diniz', 'Initials': 'ED', 'LastName': 'Callegari', 'Affiliation': 'Public Health Care Division, City of Brumadinho, Brazil.'}, {'ForeName': 'Adhemar Dias', 'Initials': 'AD', 'LastName': 'de Figueiredo Neto', 'Affiliation': 'Juiz de Fora Federal University, Juiz de Fora, Brazil; Public Health Fellowship Program, Governador Valadares Public Health Authority, Governador Valadares, Brazil.'}, {'ForeName': 'Leonardo Cançado Monteiro', 'Initials': 'LCM', 'LastName': 'Savassi', 'Affiliation': 'Family Medicine, Mental and Public Health Department, Ouro Preto Federal University, Ouro Preto, Brazil.'}, {'ForeName': 'Maria Izabel Campos', 'Initials': 'MIC', 'LastName': 'Simplicio', 'Affiliation': 'Research Division, Cardresearch - Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Brazil.'}, {'ForeName': 'Luciene Barra', 'Initials': 'LB', 'LastName': 'Ribeiro', 'Affiliation': 'Research Division, Cardresearch - Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Brazil.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Oliveira', 'Affiliation': 'Research Division, Cardresearch - Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Brazil.'}, {'ForeName': 'Ofir', 'Initials': 'O', 'LastName': 'Harari', 'Affiliation': 'Cytel, Vancouver, BC, Canada.'}, {'ForeName': 'Jamie I', 'Initials': 'JI', 'LastName': 'Forrest', 'Affiliation': 'Cytel, Vancouver, BC, Canada.'}, {'ForeName': 'Hinda', 'Initials': 'H', 'LastName': 'Ruton', 'Affiliation': 'Cytel, Vancouver, BC, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'McKay', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alla V', 'Initials': 'AV', 'LastName': 'Glushchenko', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Rayner', 'Affiliation': 'Certara, Princeton, NJ, USA; Monash Institute of Pharmaceutical Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Reiersen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Guyatt', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mills', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada. Electronic address: millsej@mcmaster.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(21)00448-4']
1154,34718468,"A randomized, placebo-controlled clinical trial of bamlanivimab and etesevimab together in high-risk ambulatory patients with COVID-19 and validation of the prognostic value of persistently high viral load.","BACKGROUND


Based on interim analyses and modelling data, lower doses of bamlanivimab and etesevimab together (700mg/1400mg) were investigated to determine optimal dose and expand availability of treatment.
METHODS


This Phase 3 portion of the BLAZE-1 trial characterized the effect of bamlanivimab with etesevimab on overall patient clinical status and virologic outcomes in ambulatory patients ≥12 years old, with mild-to-moderate COVID-19, and ≥1 risk factor for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab together (700mg/1400mg) or placebo were infused intravenously within 3 days of patients' first positive COVID-19 test.
RESULTS


769 patients were infused (median age [range]; 56.0 years [12, 93], 30.3% of patients ≥65 years of age and median duration of symptoms; 4 days). By day 29, 4/511 patients (0.8%) in the antibody treatment group had a COVID-19-related hospitalization or any-cause death, as compared with 15/258 patients (5.8%) in the placebo group (Δ[95% CI]=-5.0 [-8.0, -2.1], p<0.001). No deaths occurred in the bamlanivimab and etesevimab group compared with 4 deaths (all COVID-19-related) in the placebo group. Patients receiving antibody treatment had a greater mean reduction in viral load from baseline to Day 7 (Δ[95% CI]=-0.99 [-1.33, -0.66], p<0.0001) compared with those receiving placebo. Persistently high viral load at Day 7 correlated with COVID-19-related hospitalization or any-cause death by Day 29 in all BLAZE-1 cohorts investigated.
CONCLUSIONS


These data support the use of bamlanivimab and etesevimab (700mg/1400mg) for ambulatory patients at high risk for severe COVID-19. Evolution of SARS-CoV-2 variants will require continued monitoring to determine the applicability of this treatment.",2021,Patients receiving antibody treatment had a greater mean reduction in viral load from baseline to Day 7 (Δ[95% CI]=-0.99 [,"['high-risk ambulatory patients with COVID-19 and validation of the prognostic value of persistently high viral load', '769 patients were infused (median age [range]; 56.0 years [12, 93], 30.3% of patients ≥65 years of age and median duration of symptoms; 4 days', 'ambulatory patients at high risk for severe COVID-19', 'ambulatory patients ≥12 years old, with mild-to-moderate COVID-19, and ≥1 risk factor for progressing to severe COVID-19 and/or hospitalization']","['placebo', 'bamlanivimab with etesevimab', 'bamlanivimab and etesevimab']","['deaths', 'overall patient clinical status and virologic outcomes', 'COVID-19-related hospitalization or any-cause death', 'viral load']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",769.0,0.39923,Patients receiving antibody treatment had a greater mean reduction in viral load from baseline to Day 7 (Δ[95% CI]=-0.99 [,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dougan', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Azizad', 'Affiliation': 'Valley Clinical Trials Northridge, Northridge, CA, USA.'}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Mocherla', 'Affiliation': 'Las Vegas Medical Research Center, 8530 W Sunset Rd Ste 300, Las Vegas, NV, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': 'Baylor University Medical Center and 5Baylor Scott and White Research Institute, Dallas, TX, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, 8700 Beverly Blvd, Los Angeles, CA, USA.""}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Hebert', 'Affiliation': 'NOLA Research Works, New Orleans, LA, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Perry', 'Affiliation': 'Gadolin Research, Beaumont, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Boscia', 'Affiliation': 'Vitalink Research, Union, SC, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Heller', 'Affiliation': 'Long Beach Clinical Trials, Long Beach, CA, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': 'Care Access, Lake Charles, CA, USA.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Crystal', 'Affiliation': 'Eastside Research Associates, Redmond, WA, USA.'}, {'ForeName': 'Awawu', 'Initials': 'A', 'LastName': 'Igbinadolor', 'Affiliation': 'Monroe Biomedical Research, NC, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Huhn', 'Affiliation': 'Cook County Health, Chicago, IL, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cardona', 'Affiliation': 'Indago Research and Health Center, FL, USA.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Shawa', 'Affiliation': 'Franciscan St Francis Indy, Indianapolis, IN, USA.'}, {'ForeName': 'Princy', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Georgetown University Medical Center, Washington DC, USA.'}, {'ForeName': 'Andra', 'Initials': 'A', 'LastName': 'Blomkalns', 'Affiliation': 'Stanford University School of Medicine, Palo Alto CA, USA.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Adams', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Van Naarden', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Custer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Knorr', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Oakley', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Schade', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Holzer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Ebert', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Higgs', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Sabo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Dipak R', 'Initials': 'DR', 'LastName': 'Patel', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Matan C', 'Initials': 'MC', 'LastName': 'Dabora', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Skovronsky', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nirula', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciab912']
1155,34713713,Fecal Microbiome Composition Does Not Predict Diet-Induced TMAO Production in Healthy Adults.,"Background Trimethylamine- N -oxide (TMAO) is a small molecule derived from the metabolism of dietary nutrients by gut microbes and contributes to cardiovascular disease. Plasma TMAO increases following consumption of red meat. This metabolic change is thought to be partly because of the expansion of gut microbes able to use nutrients abundant in red meat. Methods and Results We used data from a randomized crossover study to estimate the degree to which TMAO can be estimated from fecal microbial composition. Healthy participants received a series of 3 diets that differed in protein source (red meat, white meat, and non-meat), and fecal, plasma, and urine samples were collected following 4 weeks of exposure to each diet. TMAO was quantitated in plasma and urine, while shotgun metagenomic sequencing was performed on fecal DNA. While the cai gene cluster was weakly correlated with plasma TMAO (rho=0.17,  P =0.0007), elastic net models of TMAO were not improved by abundances of bacterial genes known to contribute to TMAO synthesis. A global analysis of all taxonomic groups, genes, and gene families found no meaningful predictors of TMAO. We postulated that abundances of known genes related to TMAO production do not predict bacterial metabolism, and we measured choline- and carnitine-trimethylamine lyase activity during fecal culture. Trimethylamine lyase genes were only weakly correlated with the activity of the enzymes they encode. Conclusions Fecal microbiome composition does not predict systemic TMAO because, in this case, gene copy number does not predict bacterial metabolic activity. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01427855.",2021,"A global analysis of all taxonomic groups, genes, and gene families found no meaningful predictors of TMAO.","['Healthy participants', 'Healthy Adults']","['N -oxide (TMAO', ' Trimethylamine']","['Plasma TMAO', 'TMAO', 'plasma TMAO']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0030015', 'cui_str': 'Oxides'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0077172', 'cui_str': 'trimethylamine'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}]",,0.0827002,"A global analysis of all taxonomic groups, genes, and gene families found no meaningful predictors of TMAO.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ferrell', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bazeley', 'Affiliation': 'Department of Quantitative Health Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Zeneng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Bruce S', 'Initials': 'BS', 'LastName': 'Levison', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Xinmin S', 'Initials': 'XS', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Krauss', 'Affiliation': 'University of California San Francisco Oakland CA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'Department of Pediatrics Department of Computer Science and Engineering Department of Bioengineering, and The Center for Microbiome Innovation University of California, San Diego La Jolla CA.'}, {'ForeName': 'Aldons J', 'Initials': 'AJ', 'LastName': 'Lusis', 'Affiliation': 'Departments of Human Genetics and Medicine David Geffen School of Medicine University of California Los Angeles Los Angeles CA.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Garcia-Garcia', 'Affiliation': 'Life Sciences Transformative Platform Technologies Procter & Gamble Cincinnati OH.'}, {'ForeName': 'Stanley L', 'Initials': 'SL', 'LastName': 'Hazen', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}]",Journal of the American Heart Association,['10.1161/JAHA.121.021934']
1156,34706211,A structured physical activity program in an adolescent population with overweight or obesity: a prospective interventional study.,"Obesity is a significant health problem, with increasing involvement of young population worldwide. The aim of this study was to evaluate the effects of 2 different types of physical exercise (resistance vs. combined aerobic-resistance) on cardiovascular and anthropometric profile of a sample of sedentary adolescents with overweight and obesity. After undergoing clinical, cardiovascular and anthropometric-metabolic evaluation (T0), subjects with overweight and obesity were randomized to a 6-month resistance or combined aerobic-resistance training program. Clinical, cardiovascular and anthropometric-metabolic evaluations were repeated after 6 months of training (T1) and after 3 months of detraining (T2). Thirty adolescents with overweight/obesity were enrolled and 20 subjects completed training program. A significant improvement in body composition was detected after 6 months, with a reduction of body mass index (32.1 [30.5 to 34.4] vs. 31.1 [29.6 to 33.4] kg/m 2 ,  p  = 0.02) and adipose tissue (45.5 [41.1 to 49.7] vs. 41.6 [37.0 to 49.2] kg,  p  < 0.01). A reduction in diastolic blood pressure (75.5 ± 8.9 vs. 68.2 ± 6.4 mm Hg,  p  = 0.02) and pulse wave velocity (5.7 [5.1 to 5.9] vs. 5.2 [4.7 to 5.7] m/s,  p  = 0.04) was also observed. Persistence of the effect on the most important parameters was observed also after detraining period. In conclusion, regular physical exercise induces positive metabolic and cardiovascular effects, persisting even after brief discontinuation.  Novelty:  Physical exercise induces positive effect on cardiovascular risk profile. Positive effects persist also after brief discontinuation. Physical exercise reduces early signs of autonomic disfunction.",2022,"A reduction in Diastolic blood pressure (75.5 ± 8.9 vs 68.2 ± 6.4 mmHg, p=0.02) and Pulse Wave Velocity (5.7 [5.1-5.9] vs 5.2 [4.7-5.7] m/s, p=0.04) was also observed.","['adolescent population with overweight and obesity', 'Thirty adolescents with overweight/obesity were enrolled; 20 subjects completed', 'subjects with overweight and obesity', 'sedentary adolescents with overweight and obesity']","['physical exercise (resistance vs combined aerobic-resistance', 'training program', '6-months resistance or combined aerobic-resistance training program', 'Regular physical exercise', 'Physical exercise', 'structured physical activity program']","['Pulse Wave Velocity', 'Clinical, cardiovascular and anthropometric-metabolic evaluations', 'cardiovascular risk profile', 'BMI', 'Diastolic blood pressure', 'body composition', 'positive metabolic and cardiovascular effects', 'adipose tissue', 'cardiovascular and anthropometric profile']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",30.0,0.0103781,"A reduction in Diastolic blood pressure (75.5 ± 8.9 vs 68.2 ± 6.4 mmHg, p=0.02) and Pulse Wave Velocity (5.7 [5.1-5.9] vs 5.2 [4.7-5.7] m/s, p=0.04) was also observed.","[{'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Fanelli', 'Affiliation': 'Department of Medical Sciences, Internal Medicine and Hypertension Division, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Abate Daga', 'Affiliation': 'Department of Physical Education and Sports, University of Turin, Turin, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pappaccogli', 'Affiliation': 'Department of Medical Sciences, Internal Medicine and Hypertension Division, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Eula', 'Affiliation': 'Department of Medical Sciences, Internal Medicine and Hypertension Division, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Astarita', 'Affiliation': 'Department of Medical Sciences, Internal Medicine and Hypertension Division, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Mingrone', 'Affiliation': 'Department of Medical Sciences, Internal Medicine and Hypertension Division, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Fasano', 'Affiliation': 'Department of Medical Sciences, Internal Medicine and Hypertension Division, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Magnino', 'Affiliation': 'Department of Medical Sciences, Internal Medicine and Hypertension Division, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Schiavone', 'Affiliation': 'Department of Medical Sciences, Internal Medicine and Hypertension Division, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Rabbone', 'Affiliation': 'Department of Paediatrics, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Gollin', 'Affiliation': 'Department of Physical Education and Sports, University of Turin, Turin, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Rabbia', 'Affiliation': 'Department of Medical Sciences, Internal Medicine and Hypertension Division, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Veglio', 'Affiliation': 'Department of Medical Sciences, Internal Medicine and Hypertension Division, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2021-0092']
1157,34709497,Evaluation of adalimumab biosimilar candidate (HS016) in Chinese patients with active ankylosing spondylitis based on a health survey: sub-analysis of a phase 3 study.,"OBJECTIVE


The equivalence of the biosimilar HS016 to adalimumab (Humira) for the treatment of active ankylosing spondylitis (AS) patients has been previously validated. The aim was to compare the efficacy of HS016 and adalimumab in stratified subgroups at different time points using Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S) and short form 36 (SF-36) questionnaires.
METHODS


We carried out a multicenter, randomized, double-blind, parallel, positive control, phase 3 trial of patients with active AS. They were selected randomly to be subcutaneously administered 40 mg HS016 or adalimumab every 2 weeks for a total treatment period of 24 weeks in a 2:1 ratio. A health surveys were used to assess mental and physical improvements of patients as well as other factors.
RESULTS


HAQ-S revealed that changes in scores from baseline in both groups were time dependent until 14 weeks and that during the first 4 weeks of treatment the changes declined rapidly. The SF-36 health survey revealed that both HS016 and adalimumab produced rapid beneficial effects against AS during the first 2 weeks of therapy, which gradually declined between 2 and 12 weeks and flattened out after 12 weeks until 24 weeks.
CONCLUSION


This trial demonstrated that both HS016 and adalimumab produced rapid improvements in symptoms during the first 2 weeks of treatment. These findings suggest that HS016 is an alternative economical treatment for Chinese AS patients producing a rapid amelioration of symptoms, aiding them to recover their lifestyle satisfaction.
TRIAL REGISTRATION


http://www.chictr.org.cn/enindex.aspx , ChiCTR1900022520, retrospectively registered. Key points • HS016 and adalimumab produced rapid AS symptom improvements during the first 2 weeks followed by a slowdown of improvements until week 4 with afterwards few improvements evaluated by HAQ-S • The improvements according to the short form of the 36 (SF-36) questionnaires revealed similar trends as for HAQ-S • There was no significant difference in HAQ-S and SF-36 scores between HS016 and adalimumab.",2022,The improvements according to the short form of the 36 (SF-36) questionnaires revealed similar trends as for HAQ-S •,"['Chinese AS patients', 'stratified subgroups at different time points using Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S) and short form 36 (SF-36) questionnaires', 'active ankylosing spondylitis (AS) patients', 'patients with active AS', 'Chinese patients with active ankylosing spondylitis']","['HS016 or adalimumab', 'HS016', 'adalimumab biosimilar candidate (HS016', 'adalimumab (Humira', 'HS016 and adalimumab']","['HAQ-S •', 'HAQ-S and SF-36 scores']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0949691', 'cui_str': 'Disorder of joint of spine'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C1171255', 'cui_str': 'Humira'}]","[{'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0949691', 'cui_str': 'Disorder of joint of spine'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.16368,The improvements according to the short form of the 36 (SF-36) questionnaires revealed similar trends as for HAQ-S •,"[{'ForeName': 'Jinmei', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, National Clinical Research Center for Immunologic Diseases, Ministry of Science and Technology, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Mengtao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, National Clinical Research Center for Immunologic Diseases, Ministry of Science and Technology, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Rheumatology and Immunology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Dongbao', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology, Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Wan', 'Affiliation': 'Department of Rheumatology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Huaxiang', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Lindi', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Rheumatology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Huaxiang', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Rheumatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': 'Department of Rheumatology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Cibo', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Rheumatology, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Xiumei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Xiangyuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Rheumatology, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Tianwang', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Rheumatology, The Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Zhuzhou Central Hospital, Zhuzhou, China.'}, {'ForeName': 'Dongyi', 'Initials': 'D', 'LastName': 'He', 'Affiliation': 'Department of Rheumatology, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Rheumatology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Anbin', 'Initials': 'A', 'LastName': 'Huang', 'Affiliation': 'Department of Rheumatology, Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Rheumatology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Zhuoli', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Rheumatology, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, The Second Affiliated Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, National Clinical Research Center for Immunologic Diseases, Ministry of Science and Technology, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China. zengxfpumc@163.com.'}]",Clinical rheumatology,['10.1007/s10067-021-05943-w']
1158,34710571,Antitumor activity of ipilimumab or BRAF ± MEK inhibition after pembrolizumab treatment in patients with advanced melanoma: analysis from KEYNOTE-006.,"BACKGROUND


Antitumor activity of ipilimumab or BRAF ± MEK inhibitors (BRAFi ± MEKi) following pembrolizumab administration in melanoma is poorly characterized.
PATIENTS AND METHODS


In the phase III KEYNOTE-006 study, patients with unresectable stage III/IV melanoma received pembrolizumab (10 mg/kg) once every 2 or 3 weeks (Q3W) or ipilimumab (3 mg/kg) Q3W. The current post hoc analysis evaluates outcomes with ipilimumab or BRAFi ± MEKi as first subsequent systemic therapy after pembrolizumab administration and includes patients who completed or discontinued pembrolizumab after one or more dose. Pembrolizumab arms were pooled.
RESULTS


At data cut-off (4 December 2017), median follow-up was 46.9 months. Of 555 pembrolizumab-treated patients, first subsequent therapy was ipilimumab for 103 (18.6%) and BRAFi ± MEKi for 59 (10.6%) [33 received BRAFi + MEKi, 26 BRAFi alone; 37 (62.7%) were BRAFi ± MEKi naïve]. In the subsequent ipilimumab group, ORR with previous pembrolizumab was 17.5% [1 complete response (CR); 17 partial response (PR)]; 79.6% had discontinued pembrolizumab due to progressive disease (PD); median overall survival (OS) was 21.5 months. ORR with subsequent ipilimumab was 15.5%; 11/16 responses (8 CRs; 3 PRs) were ongoing. ORR with subsequent ipilimumab was 9.7% for patients with PD as best response to pembrolizumab. Median OS from ipilimumab initiation was 9.8 months. In the subsequent BRAFi ± MEKi group, ORR with previous pembrolizumab was 13.5% (8 PR); 76.3% had discontinued pembrolizumab due to PD; median OS was 17.9 months. ORR with subsequent BRAFi ± MEKi was 30.5%, 7/18 responses (4 CR, 3 PR) were ongoing. Median OS from BRAFi ± MEKi initiation was 12.9 months. ORR for BRAFi ± MEKi-naïve patients who received subsequent BRAFi ± MEKi was 43.2%; 6/16 were ongoing (3 CR, 3 PR).
CONCLUSIONS


Ipilimumab and BRAFi ± MEKi have antitumor activity as first subsequent therapy after pembrolizumab in patients with advanced melanoma.",2022,ORR with subsequent ipilimumab was 15.5%; 11/16 responses (8 CRs; 3 PRs) were ongoing.,"['Patients With Advanced Melanoma', 'patients with advanced melanoma', 'patients with unresectable stage III/IV melanoma received']","['Pembrolizumab', 'ORR with subsequent ipilimumab', 'Ipilimumab or BRAF ± MEK Inhibition', 'pembrolizumab 10 mg/kg once every 2 or 3 weeks (Q3W) or ipilimumab 3 mg/kg Q3W', 'ipilimumab or BRAFi ± MEKi']",['Median OS'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0169101', 'cui_str': 'MAP Kinase Kinases'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.15233,ORR with subsequent ipilimumab was 15.5%; 11/16 responses (8 CRs; 3 PRs) were ongoing.,"[{'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, Australia; Faculty of Medicine & Health, The University of Sydney, Sydney, Australia; Charles Perkins Centre, The University of Sydney, Sydney, Australia; Royal North Shore and Mater Hospital, Sydney, Australia. Electronic address: georgina.long@sydney.edu.au.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': 'Hospital Clinic de Barcelona and IDIBAPS, Barcelona, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': 'Université Lille, Inserm U1189, Centre Hospitalier Régional Universitaire de Lille, Lille, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lorigan', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Manchester; Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Blank', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mohr', 'Affiliation': 'Elbe-Klinikum Buxtehude, Buxtehude, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schachter', 'Affiliation': 'Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center at Tel Hashomer, Ramat Gan, Israel.'}, {'ForeName': 'J-J', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix Marseille University, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lotem', 'Affiliation': 'Sharett Institute of Oncology, Hadassah Hebrew Medical Center, Jerusalem, Israel.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'The Churchill Hospital and The University of Oxford, Oxford, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Neyns', 'Affiliation': 'Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Steven', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'David Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Walpole', 'Affiliation': 'Princess Alexandra Hospital, Brisbane, Australia; University of Queensland, Brisbane, Australia.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, Australia; Westmead and Blacktown Hospitals, New South Wales, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lebbe', 'Affiliation': 'Université de Paris, APHP Hôpital Saint-Louis, Dermatology Department, DMU ICARE, INSERM U-976, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sznol', 'Affiliation': 'Yale Cancer Center, New Haven, CT, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jensen', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Leiby', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Department of Oncology, Service of Dermatology, Gustave Roussy, Villejuif, France; Paris-Saclay University, Orsay, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.10.010']
1159,34715091,A Pilot Randomized Trial of Heart Rate Monitoring Using Conventional Versus a New Electrocardiogram Algorithm during Neonatal Resuscitation at Birth.,"Current guidelines support the use of a cardiac monitor during neonatal resuscitation. Infants born preterm randomized to a novel electrocardiogram algorithm displayed a heart rate sooner than the conventional electrocardiogram algorithm. Although resuscitation outcomes were not different, the availability of an earlier heart rate may benefit neonatal providers during high-risk resuscitations. TRIAL REGISTRATION: ClinicalTrials.govNCT04587934.",2022,"Although resuscitation outcomes were not different, availability of an earlier heart rate may benefit neonatal providers during high-risk resuscitations.",[],"['novel ECG algorithm', 'Heart Rate Monitoring Using Conventional Versus a New ECG Algorithm']",['heart rate sooner'],[],"[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0199637', 'cui_str': 'Cardiotachometry'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0607788,"Although resuscitation outcomes were not different, availability of an earlier heart rate may benefit neonatal providers during high-risk resuscitations.","[{'ForeName': 'Anup C', 'Initials': 'AC', 'LastName': 'Katheria', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA. Electronic address: anup.katheria@sharp.com.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Morales', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Shashank', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA.'}, {'ForeName': 'Wade D', 'Initials': 'WD', 'LastName': 'Rich', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA.'}, {'ForeName': 'Neil N', 'Initials': 'NN', 'LastName': 'Finer', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2021.10.037']
1160,33647393,Association of Urine Biomarkers of Kidney Tubule Injury and Dysfunction With Frailty Index and Cognitive Function in Persons With CKD in SPRINT.,"RATIONALE & OBJECTIVE


The associations of the glomerular markers of kidney disease, estimated glomerular filtration rate (eGFR) and albuminuria, with frailty and cognition are well established. However, the relationship of kidney tubule injury and dysfunction with frailty and cognition is unknown.
STUDY DESIGN


Observational cross-sectional study.
SETTING & PARTICIPANTS


2,253 participants with eGFR<60mL/min/1.73m 2  in the Systolic Blood Pressure Intervention Trial (SPRINT).
EXPOSURE


Eight urine biomarkers: interleukin 18 (IL-18), kidney injury molecule 1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), chitinase-3-like protein 1 (YKL-40), monocyte chemoattractant protein 1 (MCP-1), α 1 -microglobulin (A1M), β 2 -microglobulin (B2M), and uromodulin (Umod).
OUTCOME


Frailty was measured using a previously validated frailty index (FI), categorized as fit (FI≤0.10), less fit (0.10<FI≤0.21), and frail (FI>0.21). Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA).
ANALYTICAL APPROACH


Associations between kidney tubule biomarkers with categorical FI were evaluated using multinomial logistic regression with the fit group as the reference. Cognitive function was evaluated using linear regression. Models were adjusted for demographic, behavioral, and clinical variables including eGFR and urine albumin.
RESULTS


Three of the 8 urine biomarkers of tubule injury and dysfunction were independently associated with FI. Each 2-fold higher level of urine KIM-1, a marker of tubule injury, was associated with a 1.22 (95% CI, 1.01-1.49) greater odds of being in the frail group. MCP-1, a marker of tubulointerstitial fibrosis, was associated with a 1.30 (95% CI, 1.04-1.64) greater odds of being in the frail group, and A1M, a marker of tubule reabsorptive capacity, was associated with a 1.48 (95% CI, 1.11-1.96) greater odds of being in the frail group. These associations were independent of confounders including eGFR and urine albumin, and were stronger than those of urine albumin with FI (1.15 [95% CI, 0.99-1.34]). Higher urine B2M, another marker of tubule reabsorptive capacity, was associated with worse cognitive scores at baseline (β: -0.09 [95% CI, -0.17 to-0.01]). Urine albumin was not associated with cognitive function.
LIMITATIONS


Cross-sectional design, and FI may not be generalizable in other populations.
CONCLUSIONS


Urine biomarkers of tubule injury, fibrosis, and proximal tubule reabsorptive capacity are variably associated with FI and worse cognition, independent of glomerular markers of kidney health. Future studies are needed to validate these results among other patient populations.",2021,"Eight urine biomarkers: interleukin 18 (IL-18), kidney injury molecule 1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), chitinase-3-like protein 1 (YKL-40), monocyte chemoattractant protein 1 (MCP-1),","['2,253 participants with', 'Persons With CKD in SPRINT']",[],"['worse cognitive scores', 'level of urine KIM-1', 'Higher urine B2M, another marker of tubule reabsorptive capacity', 'glomerular markers of kidney disease, estimated glomerular filtration rate (eGFR) and albuminuria, with frailty and cognition', 'Urine albumin', 'Cognitive function', 'Eight urine biomarkers: interleukin 18 (IL-18), kidney injury molecule 1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), chitinase-3-like protein 1 (YKL-40), monocyte chemoattractant protein 1 (MCP-1', 'MCP-1, a marker of tubulointerstitial fibrosis', 'Montreal Cognitive Assessment (MoCA', 'β 2 -microglobulin (B2M), and uromodulin (Umod']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]",[],"[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005149', 'cui_str': 'Beta 2 microglobulin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022663', 'cui_str': 'Glomerulus structure'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0528649', 'cui_str': 'CHI3L1 protein, human'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0077918', 'cui_str': 'Uromucoid protein'}]",2253.0,0.132307,"Eight urine biomarkers: interleukin 18 (IL-18), kidney injury molecule 1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), chitinase-3-like protein 1 (YKL-40), monocyte chemoattractant protein 1 (MCP-1),","[{'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Miller', 'Affiliation': 'Division of Nephrology-Hypertension, University of California-San Diego, San Diego, California. Electronic address: Lmmiller@health.ucsd.edu.'}, {'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Rifkin', 'Affiliation': 'Division of Nephrology-Hypertension, University of California-San Diego, San Diego, California; Veterans Affairs San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Lee', 'Affiliation': 'School of Medicine, University of California-San Francisco, San Francisco, California.'}, {'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Kurella Tamura', 'Affiliation': 'Division of Nephrology, Department of Medicine, Stanford University, and Palo Alto Veterans Affairs Health Care System, Palo Alto, California.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Tala', 'Initials': 'T', 'LastName': 'Al-Rousan', 'Affiliation': 'Herbert Wertheim School of Public Health, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shlipak', 'Affiliation': 'School of Medicine, University of California-San Francisco, San Francisco, California.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Division of Nephrology-Hypertension, University of California-San Diego, San Diego, California; Veterans Affairs San Diego Healthcare System, San Diego, California.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2021.01.009']
1161,34727737,Collateral Circulation in Thrombectomy for Stroke After 6 to 24 Hours in the DAWN Trial.,"BACKGROUND AND PURPOSE


Collaterals govern the pace and severity of cerebral ischemia, distinguishing fast or slow progressors and corresponding therapeutic opportunities. The fate of sustained collateral perfusion or collateral failure is poorly characterized. We evaluated the nature and impact of collaterals on outcomes in the late time window DAWN trial (Diffusion-Weighted Imaging or Computed Tomography Perfusion Assessment With Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention With Trevo).
METHODS


The DAWN Imaging Core Lab prospectively scored collateral grade on baseline computed tomography angiography (CTA; endovascular and control arms) and digital subtraction angiography (DSA; endovascular arm only), blinded to all other data. CTA collaterals were graded with the Tan scale and DSA collaterals were scored by ASITN grade (American Society of Interventional and Therapeutic Neuroradiology collateral score). Descriptive statistics characterized CTA collateral grade in all DAWN subjects and DSA collaterals in the endovascular arm. The relationship between collateral grade and day 90 outcomes were separately analyzed for each treatment arm.
RESULTS


Collateral circulation to the ischemic territory was evaluated on CTA (n=144; median 2, 0-3) and DSA (n=57; median 2, 1-4) before thrombectomy in 161 DAWN subjects (mean age 69.8±13.6 years; 55.3% women; 91 endovascular therapy, 70 control). CTA revealed a broad range of collaterals (Tan grade 3, n=64 [44%]; 2, n=45 [31%]; 1, n=31 [22%]; 0, n=4 [3%]). DSA also showed a diverse range of collateral grades (ASITN grade 4, n=4; 3, n=22; 2, n=27; 1, n=4). Across treatment arms, baseline demographics, clinical variables except atrial fibrillation (41.6% endovascular versus 25.0% controls,  P =0.04), and CTA collateral grades were balanced. Differences were seen across the 3 levels of collateral flow (good, fair, poor) for baseline National Institutes of Health Stroke Scale, blood glucose <150, diabetes, previous ischemic stroke, baseline and 24-hour core infarct volume, baseline and 24-hour Alberta Stroke Program Early CT Score, dramatic infarct progression, final Thrombolysis in Cerebral Infarction 2b+, and death. Collateral flow was a significant predictor of 90-day modified Rankin Scale score of 0 to 2 in the endovascular arm, with 43.7% (31/71) of subjects with good collaterals, 30.8% (16/52) of subjects with fair collaterals, and 17.7% (6/34) of subjects with poor collaterals reaching modified Rankin Scale score of 0 to 2 at 90 days ( P =0.026).
CONCLUSIONS


DAWN subjects enrolled at 6 to 24 hours after onset with limited infarct cores had a wide range of collateral grades on both CTA and DSA. Even in this late time window, better collaterals lead to slower stroke progression and better functional outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02142283.",2022,"Collateral flow was a significant predictor of 90-day modified Rankin Scale score of 0 to 2 in the endovascular arm, with 43.7% (31/71) of subjects with good collaterals, 30.8% (16/52) of subjects with fair collaterals, and 17.7% (6/34) of subjects with poor collaterals reaching modified Rankin Scale score of 0 to 2 at 90 days ( P =0.026).
",[],"['digital subtraction angiography (DSA; endovascular', 'DSA', 'CTA']","['Rankin Scale score', '90-day modified Rankin Scale score', 'Tan scale and DSA collaterals', 'baseline demographics, clinical variables except atrial fibrillation', '3 levels of collateral flow (good, fair, poor) for baseline National Institutes of Health Stroke Scale, blood glucose <150, diabetes, previous ischemic stroke, baseline and 24-hour core infarct volume, baseline and 24-hour Alberta Stroke Program Early CT Score, dramatic infarct progression, final Thrombolysis in Cerebral Infarction 2b+, and death', 'Collateral flow']",[],"[{'cui': 'C0002979', 'cui_str': 'Digital subtraction angiography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040854', 'cui_str': 'Triacetoneamine-N-Oxyl'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002979', 'cui_str': 'Digital subtraction angiography'}, {'cui': 'C1275670', 'cui_str': 'Collateral branch of vessel'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",161.0,0.140165,"Collateral flow was a significant predictor of 90-day modified Rankin Scale score of 0 to 2 in the endovascular arm, with 43.7% (31/71) of subjects with good collaterals, 30.8% (16/52) of subjects with fair collaterals, and 17.7% (6/34) of subjects with poor collaterals reaching modified Rankin Scale score of 0 to 2 at 90 days ( P =0.026).
","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Liebeskind', 'Affiliation': 'Neurovascular Imaging Research Core, UCLA (D.S.L., H.S.).'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Saber', 'Affiliation': 'Neurovascular Imaging Research Core, UCLA (D.S.L., H.S.).'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xiang', 'Affiliation': 'Prospect Analytical, Inc, San Jose, CA (B.X.).'}, {'ForeName': 'Ashutosh P', 'Initials': 'AP', 'LastName': 'Jadhav', 'Affiliation': 'Barrow Neurological Institute, Phoenix, AZ (A.P.J., T.G.J.).'}, {'ForeName': 'Tudor G', 'Initials': 'TG', 'LastName': 'Jovin', 'Affiliation': 'Barrow Neurological Institute, Phoenix, AZ (A.P.J., T.G.J.).'}, {'ForeName': 'Diogo C', 'Initials': 'DC', 'LastName': 'Haussen', 'Affiliation': 'Emory University School of Medicine/Grady Memorial Hospital, Atlanta, GA (D.C.H., R.G.N.).'}, {'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'Budzik', 'Affiliation': 'OhioHealth Riverside Methodist Hospital, Columbus, OH (R.F.B.).'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Bonafe', 'Affiliation': 'Hôpital Gui-de-Chauliac, Montpellier, France (A.B.).'}, {'ForeName': 'Parita', 'Initials': 'P', 'LastName': 'Bhuva', 'Affiliation': 'Texas Stroke Institute, Dallas-Fort Worth (P.B.).'}, {'ForeName': 'Dileep R', 'Initials': 'DR', 'LastName': 'Yavagal', 'Affiliation': 'University of Miami Miller School of Medicine-Jackson Memorial Hospital, Miami, FL (D.R.Y.).'}, {'ForeName': 'Ricardo A', 'Initials': 'RA', 'LastName': 'Hanel', 'Affiliation': 'Baptist Jacksonville, Jacksonville, FL (R.A.H.).'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ribo', 'Affiliation': ""Hospital Vall d'Hebrón, Barcelona, Spain (M.R.).""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Cognard', 'Affiliation': 'University Hospital of Toulouse, France (C.C.).'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Sila', 'Affiliation': 'University Hospital of Cleveland, OH (C.S.).'}, {'ForeName': 'Ameer E', 'Initials': 'AE', 'LastName': 'Hassan', 'Affiliation': 'University of Texas Rio Grande Valley-Valley Baptist Medical Center, Harlingen (A.E.H.).'}, {'ForeName': 'Wade S', 'Initials': 'WS', 'LastName': 'Smith', 'Affiliation': 'University of California, San Francisco, San Francisco (W.S.S.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Saver', 'Affiliation': 'UCLA, Los Angeles, CA (J.L.S.).'}, {'ForeName': 'Raul G', 'Initials': 'RG', 'LastName': 'Nogueira', 'Affiliation': 'Emory University School of Medicine/Grady Memorial Hospital, Atlanta, GA (D.C.H., R.G.N.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.121.034471']
1162,34714720,Immunogenicity and safety of a quadrivalent high-dose inactivated influenza vaccine compared with a standard-dose quadrivalent influenza vaccine in healthy people aged 60 years or older: a randomized Phase III trial.,"A quadrivalent high-dose inactivated influenza vaccine (IIV4-HD) is licensed for adults ≥65 y of age based on immunogenicity and efficacy studies. However, IIV4-HD has not been evaluated in adults aged 60-64 y. This study compared immunogenicity and safety of IIV4-HD with a standard-dose quadrivalent influenza vaccine (IIV4-SD) in adults aged ≥60 y. This Phase III, randomized, modified double-blind, active-controlled study enrolled 1,528 participants aged ≥60 y, randomized 1:1 to a single injection of IIV4-HD or IIV4-SD. Hemagglutination inhibition (HAI) geometric mean titers (GMTs) were measured at baseline and D 28 and seroconversion assessed. Safety was described for 180 d after vaccination. The primary immunogenicity objective was superiority of IIV4-HD versus IIV4-SD, for all four influenza strains 28 d post vaccination in participants aged 60-64 and ≥65 y. IIV4-HD induced a superior immune response versus IIV4-SD in terms of GMTs in participants aged 60-64 y and those aged ≥65 y for all four influenza strains. IIV4-HD induced higher GMTs in those aged 60-64 y than those aged ≥65 y. Seroconversion rates were higher for IIV4-HD versus IIV4-SD in each age-group for all influenza strains. Both vaccines were well tolerated in participants ≥60 y of age, with no safety concerns identified. More solicited reactions were reported with IIV4-HD than with IIV4-SD. IIV4-HD provided superior immunogenicity versus IIV4-SD and was well tolerated in adults aged ≥60 y. IIV4-HD is assumed to offer improved protection against influenza compared with IIV4-SD in adults aged ≥60 y, as was previously assessed for adults aged ≥65 y.",2021,IIV4-HD provided superior immunogenicity versus IIV4-SD and was well tolerated in adults aged ≥60,"['adults aged 60-64\xa0y', 'participants ≥60\xa0y of age', '1,528 participants aged ≥60\xa0y', 'adults aged ≥60', 'healthy people aged 60 years or older', 'participants aged 60-64 y and those aged ≥65\xa0y for all four influenza strains', 'adults aged ≥60 y, as was previously assessed for adults aged ≥65', 'adults ≥65\xa0y of age', 'participants aged 60-64 and ≥65']","['quadrivalent high-dose inactivated influenza vaccine', 'IIV4-HD or IIV4-SD', 'standard-dose quadrivalent influenza vaccine', 'influenza vaccine (IIV4-HD', 'IIV4-HD with a standard-dose quadrivalent influenza vaccine (IIV4-SD', 'IIV4-HD versus IIV4-SD']","['Immunogenicity and safety', 'IIV4-HD induced higher GMTs', 'Hemagglutination inhibition (HAI) geometric mean titers (GMTs', 'Safety', 'Seroconversion rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",1528.0,0.178104,IIV4-HD provided superior immunogenicity versus IIV4-SD and was well tolerated in adults aged ≥60,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Pepin', 'Affiliation': ""Global Clinical Sciences, Sanofi Pasteur, Marcy L'Etoile, France.""}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Nicolas', 'Affiliation': 'Clinical Immunology & Allergology Department, Centre Hospitalier Lyon-Sud, Lyon, France.'}, {'ForeName': 'Henryk', 'Initials': 'H', 'LastName': 'Szymanski', 'Affiliation': 'Paediatrics, St Hedwig of Silesia Hospital Trzebnica, Prusicka, Trzebnica, Poland.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Leroux-Roels', 'Affiliation': 'Centrum Voor Vaccinologie, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schaum', 'Affiliation': 'RED-Institut, Oldenburg in Holstein, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Icardi', 'Affiliation': 'Department of Health Sciences, Ospedale Policlinico S. Martino IRCCS, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'Global Pharmacovigilance, Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Tabar', 'Affiliation': ""Global Clinical Sciences, Sanofi Pasteur, Marcy L'Etoile, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2021.1983387']
1163,34717041,Efficacy and safety of givosiran for acute hepatic porphyria: 24-month interim analysis of the randomized phase 3 ENVISION study.,"BACKGROUND & AIMS


Upregulation of hepatic delta-aminolevulinic acid synthase 1 with accumulation of potentially toxic heme precursors delta-aminolevulinic acid and porphobilinogen is fundamental to the pathogenesis of acute hepatic porphyria.
AIMS


evaluate long-term efficacy and safety of givosiran in acute hepatic porphyria.
METHODS


Interim analysis of ongoing ENVISION study (NCT03338816), after all active patients completed their Month 24 visit. Patients with acute hepatic porphyria (≥12 years) with recurrent attacks received givosiran (2.5 mg/kg monthly) (n = 48) or placebo (n = 46) for 6 months (double-blind period); 93 received givosiran (2.5 mg or 1.25 mg/kg monthly) in the open-label extension (continuous givosiran, n = 47/48; placebo crossover, n = 46/46). Endpoints included annualized attack rate, urinary delta-aminolevulinic acid and porphobilinogen levels, hemin use, daily worst pain, quality of life, and adverse events.
RESULTS


Patients receiving continuous givosiran had sustained annualized attack rate reduction (median 1.0 in double-blind period, 0.0 in open-label extension); in placebo crossover patients, median annualized attack rate decreased from 10.7 to 1.4. Median annualized days of hemin use were 0.0 (double-blind period) and 0.0 (open-label extension) for continuous givosiran patients and reduced from 14.98 to 0.71 for placebo crossover patients. Long-term givosiran led to sustained lowering of delta-aminolevulinic acid and porphobilinogen and improvements in daily worst pain and quality of life. Safety findings were consistent with the double-blind period.
CONCLUSIONS


Long-term givosiran has an acceptable safety profile and significantly benefits acute hepatic porphyria patients with recurrent attacks by reducing attack frequency, hemin use, and severity of daily worst pain while improving quality of life.",2022,"RESULTS


Patients receiving continuous givosiran had sustained annualized attack rate reduction (median 1.0 in double-blind period, 0.0 in open-label extension); in placebo crossover patients, median annualized attack rate decreased from 10.7 to 1.4.","['Patients with acute hepatic porphyria (≥12 years) with recurrent attacks received givosiran (2.5 mg/kg monthly) (n=48) or', 'acute hepatic porphyria patients with recurrent attacks', 'acute hepatic porphyria']","['givosiran (2.5 mg or 1.25 mg/kg monthly) in the open-label extension (continuous givosiran, n=47/48; placebo', 'placebo', 'givosiran']","['daily worst pain and quality of life', 'sustained annualized attack rate reduction', 'annualized attack rate, urinary delta-aminolevulinic acid and porphobilinogen levels, hemin use, daily worst pain, quality of life, and adverse events', 'Efficacy and safety', 'median annualized attack rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0268328', 'cui_str': 'Porphobilinogen synthase deficiency'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C4688584', 'cui_str': 'givosiran'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C4688584', 'cui_str': 'givosiran'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0032704', 'cui_str': 'Porphobilinogen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018988', 'cui_str': 'Hemin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.24673,"RESULTS


Patients receiving continuous givosiran had sustained annualized attack rate reduction (median 1.0 in double-blind period, 0.0 in open-label extension); in placebo crossover patients, median annualized attack rate decreased from 10.7 to 1.4.","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ventura', 'Affiliation': 'Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Herbert L', 'Initials': 'HL', 'LastName': 'Bonkovsky', 'Affiliation': 'Section on Gastroenterology and Hepatology, Wake Forest University/North Carolina Baptist Medical Center, Winston-Salem, NC, USA.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Gouya', 'Affiliation': 'Centre Français des Porphyries, Paris, France.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Aguilera-Peiró', 'Affiliation': 'Hospital Clinic Barcelona, Barcelona, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Montgomery Bissell', 'Affiliation': 'UCSF Liver Center and Porphyria Center, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Penelope E', 'Initials': 'PE', 'LastName': 'Stein', 'Affiliation': ""King's College Hospital, London, UK.""}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Balwani', 'Affiliation': 'Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'D Karl E', 'Initials': 'DKE', 'LastName': 'Anderson', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kuter', 'Affiliation': 'Center for Hematology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Monroy', 'Affiliation': 'Instituto Nacional de Pediatría, Mexico City, Mexico.'}, {'ForeName': 'Jeeyoung', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Konkuk University Medical Center, Seoul, South Korea.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Ritchie', 'Affiliation': 'University of Alberta Hospital, Edmonton, Canada.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Ko', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Zhaowei', 'Initials': 'Z', 'LastName': 'Hua', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Eliane', 'Initials': 'E', 'LastName': 'Sardh', 'Affiliation': 'Porphyria Centre Sweden, Centre for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.15090']
1164,34726230,Application of the Athlete Biological Passport Approach to the Detection of Growth Hormone Doping.,"CONTEXT


Because of its anabolic and lipolytic properties, growth hormone (GH) use is prohibited in sport. Two methods based on population-derived decision limits are currently used to detect human GH (hGH) abuse: the hGH Biomarkers Test and the Isoforms Differential Immunoassay.
OBJECTIVE


We tested the hypothesis that longitudinal profiling of hGH biomarkers through application of the Athlete Biological Passport (ABP) has the potential to flag hGH abuse.
METHODS


Insulin-like growth factor 1 (IGF-1) and procollagen III peptide (P-III-NP) distributions were obtained from 7 years of anti-doping data in elite athletes (n = 11 455) and applied as priors to analyze individual profiles from an hGH administration study in recreational athletes (n = 35). An open-label, randomized, single-site, placebo-controlled administration study was carried out with individuals randomly assigned to 4 arms: placebo, or 3 different doses of recombinant hGH. Serum samples were analyzed for IGF-1, P-III-NP, and hGH isoforms and the performance of a longitudinal, ABP-based approach was evaluated.
RESULTS


An ABP-based approach set at a 99% specificity level flagged 20/27 individuals receiving hGH treatment, including 17/27 individuals after cessation of the treatment. ABP sensitivity ranged from 12.5% to 71.4% across the hGH concentrations tested following 7 days of treatment, peaking at 57.1% to 100% after 21 days of treatment, and was maintained between 37.5% and 71.4% for the low and high dose groups 1 week after cessation of treatment.
CONCLUSION


These findings demonstrate that longitudinal profiling of hGH biomarkers can provide suitable performance characteristics for use in anti-doping programs.",2022,"ABP sensitivity ranged from 12.5-71.4 % across the hGH concentrations tested following 7 days of treatment, peaking at 57.1-100 % after 21 days of treatment, and was maintained between 37.5-71.4 % for the low and high dose groups one week after cessation of treatment.
","['flagged 20/27 individuals receiving hGH treatment, including 17/27 individuals after cessation of the treatment', 'Elite (n=11,455) and recreational athletes (n=35']","['growth hormone (GH', 'placebo, or 3 different doses of recombinant hGH', 'placebo', 'Athlete Biological Passport (ABP']",['ABP sensitivity'],"[{'cui': 'C5200790', 'cui_str': 'Flags'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0691935,"ABP sensitivity ranged from 12.5-71.4 % across the hGH concentrations tested following 7 days of treatment, peaking at 57.1-100 % after 21 days of treatment, and was maintained between 37.5-71.4 % for the low and high dose groups one week after cessation of treatment.
","[{'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Equey', 'Affiliation': 'World Anti-Doping Agency (WADA), Montreal, Quebec, Canada.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Pastor', 'Affiliation': 'Integrative Pharmacology and Systems Neuroscience Research Group, Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'de la Torre Fornell', 'Affiliation': 'Integrative Pharmacology and Systems Neuroscience Research Group, Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Institute of Biochemistry, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Giraud', 'Affiliation': 'Swiss Laboratory for Doping Analyses, University Center of Legal Medicine, Genève and Lausanne, Centre Hospitalier Universitaire Vaudois and University of Lausanne, 1066 Epalinges, Switzerland.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Thevis', 'Affiliation': 'Institute of Biochemistry, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Tiia', 'Initials': 'T', 'LastName': 'Kuuranne', 'Affiliation': 'Swiss Laboratory for Doping Analyses, University Center of Legal Medicine, Genève and Lausanne, Centre Hospitalier Universitaire Vaudois and University of Lausanne, 1066 Epalinges, Switzerland.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Baume', 'Affiliation': 'World Anti-Doping Agency (WADA), Montreal, Quebec, Canada.'}, {'ForeName': 'Osquel', 'Initials': 'O', 'LastName': 'Barroso', 'Affiliation': 'World Anti-Doping Agency (WADA), Montreal, Quebec, Canada.'}, {'ForeName': 'Reid', 'Initials': 'R', 'LastName': 'Aikin', 'Affiliation': 'World Anti-Doping Agency (WADA), Montreal, Quebec, Canada.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab799']
1165,34718382,Diet and food type affect urinary pesticide residue excretion profiles in healthy individuals: results of a randomized controlled dietary intervention trial.,"BACKGROUND


Observational studies have linked pesticide exposure to various diseases, whereas organic food consumption has been associated with positive health outcomes. Organic farming standards prohibit the use of most pesticides, and organic food consumption may therefore reduce pesticide exposure.
OBJECTIVES


To determine the effects of diet (Western compared with Mediterranean) and food type (conventional compared with organic) and sex on urinary pesticide residue excretion (UPRE), as well as associations between specific diet components and UPRE.
METHODS


In this 2-wk, randomized dietary intervention trial, healthy adults were randomly allocated to an intervention (n = 13) or conventional (n = 14) group. Whereas participants in the intervention group consumed a Mediterranean diet (MedDiet) made entirely from organic foods, the conventional group consumed a MedDiet made entirely from conventional foods. Both groups consumed habitual Western diets made from conventional foods before and after the 2-wk intervention period. The primary outcome was UPRE. In addition, we assessed diet composition and pesticide residue profiles in foods eaten. Participants were aware of group assignment, but the study assessors were not.
RESULTS


During the intervention period, total UPRE was 91% lower with organic (mean 17 μg/d; 95% CI: 15, 19) than with conventional (mean 180 μg/d; 95% CI: 153, 208) food consumption (P < 0.0001). In the conventional group, switching from the habitual Western diet to the MedDiet increased insecticide excretion from 7 to 25 μg/d (P < 0.0001), organophosphate excretion from 5 to 19 μg/d (P < 0.0001), and pyrethroid residue excretion from 2.0 to 4.5 μg/d (P < 0.0001). Small but significant effects of sex were detected for chlormequat, herbicide, and total pesticide residue excretion.
CONCLUSIONS


Changing from a habitual Western diet to a MedDiet was associated with increased insecticide, organophosphate, and pyrethroid exposure, whereas organic food consumption reduced exposure to all groups of synthetic chemical pesticides. This may explain the positive health outcomes linked to organic food consumption in observational studies. This trial was registered at www.clinicaltrials.gov as NCT03254537.",2022,"d (P < 0.0001), organophosphate excretion from 5 to 19 μg/d (P ","['17\xa0μg', 'foods eaten', 'healthy adults', 'healthy individuals']","['diet (Western compared with Mediterranean) and food type (conventional compared with organic', 'Diet and food type', 'Mediterranean diet (MedDiet) made entirely from organic foods, the conventional group consumed a MedDiet made entirely from conventional foods']","['insecticide excretion', 'total UPRE', 'urinary pesticide residue excretion (UPRE', 'chlormequat, herbicide, and total pesticide residue excretion', 'organophosphate excretion', 'pyrethroid residue excretion']","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449492', 'cui_str': 'Type of food'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0282678', 'cui_str': 'Organic food'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0021576', 'cui_str': 'Insecticide'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031251', 'cui_str': 'Pesticide Residues'}, {'cui': 'C0008216', 'cui_str': 'Chlormequat'}, {'cui': 'C0019236', 'cui_str': 'Herbicide'}, {'cui': 'C0031701', 'cui_str': 'Phosphoric acid ester'}, {'cui': 'C0597329', 'cui_str': 'Pyrethroid'}]",,0.131937,"d (P < 0.0001), organophosphate excretion from 5 to 19 μg/d (P ","[{'ForeName': 'Leonidas', 'Initials': 'L', 'LastName': 'Rempelos', 'Affiliation': 'School of Agriculture, Food and Rural Development, NEFG, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Agriculture, Food and Rural Development, NEFG, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Barański', 'Affiliation': 'School of Agriculture, Food and Rural Development, NEFG, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Watson', 'Affiliation': 'Human Nutrition Research Centre, Population and Health Sciences Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Volakakis', 'Affiliation': 'Geokomi plc, Sivas-Faistos, Crete, Greece.'}, {'ForeName': 'Hans-Wolfgang', 'Initials': 'HW', 'LastName': 'Hoppe', 'Affiliation': 'Medical Laboratory Bremen, Bremen, Germany.'}, {'ForeName': 'W Nikolaus', 'Initials': 'WN', 'LastName': 'Kühn-Velten', 'Affiliation': 'Medical Laboratory Bremen, Bremen, Germany.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hadall', 'Affiliation': 'Newcastle upon Tyne Hospitals, Royal Victory Infirmary, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Gultakin', 'Initials': 'G', 'LastName': 'Hasanaliyeva', 'Affiliation': 'School of Agriculture, Food and Rural Development, NEFG, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Chatzidimitriou', 'Affiliation': 'School of Agriculture, Food and Rural Development, NEFG, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Magistrali', 'Affiliation': 'School of Agriculture, Food and Rural Development, NEFG, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Davis', 'Affiliation': 'School of Agriculture, Food and Rural Development, NEFG, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Vigar', 'Affiliation': 'NatMed, Southern Cross University, Lismore, NSW, Australia.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Średnicka-Tober', 'Affiliation': 'Institute of Human Nutrition Sciences, Warsaw University of Life Sciences, Warsaw, Poland.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Rushton', 'Affiliation': 'Modelling Evidence and Policy Group, School of Natural and Environmental Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Per Ole', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Seal', 'Affiliation': 'Human Nutrition Research Centre, Population and Health Sciences Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Leifert', 'Affiliation': 'Plant Science, Southern Cross University, Lismore, NSW, Australia.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab308']
1166,34719872,"Long-Term Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19 Subunit of Interleukin-23, Through Two Years: Results From a Phase III, Randomized, Double-Blind, Placebo-Controlled Study Conducted in Biologic-Naive Patients With Active Psoriatic Arthritis.","OBJECTIVE


To assess long-term efficacy and safety of guselkumab, an interleukin-23 p19 subunit (IL-23p19) inhibitor, in patients with active psoriatic arthritis (PsA) from the phase III DISCOVER-2 trial.
METHODS


In the DISCOVER-2 trial, patients with active PsA (≥5 swollen joints and ≥5 tender joints; C-reactive protein level ≥0.6 mg/dl) despite prior nonbiologic therapy were randomized to receive the following: guselkumab 100 mg every 4 weeks; guselkumab 100 mg at weeks 0 and 4 and then every 8 weeks; or placebo with crossover to guselkumab 100 mg every 4 weeks, beginning at week 24. Efficacy assessments included American College of Rheumatology ≥20%/50%/70% improvement criteria (ACR20/50/70), Investigator's Global Assessment (IGA) of psoriasis score of 0 (indicating complete skin clearance), resolution of enthesitis (Leeds Enthesitis Index) and dactylitis (Dactylitis Severity Score), and changes in the Sharp/van der Heijde modified radiographic scores for PsA. Clinical data (imputed as no response/no change from baseline if missing) and observed radiographic data were summarized through week 100; safety assessments continued through week 112.
RESULTS


Of the 739 randomized and treated patients, 652 (88%) completed treatment through week 100. Across groups of guselkumab-treated patients (including those in the placebo-guselkumab crossover group), the following findings at week 100 indicated that amelioration of arthritis signs/symptoms and extraarticular manifestations was durable through 2 years: ACR20 response (68-76%), ACR50 response (48-56%), ACR70 response (30-36%), IGA score of 0 (55-67%), enthesitis resolution (62-70%), and dactylitis resolution (72-83%). Mean changes in the Sharp/van der Heijde modified score for PsA from weeks 52 to week 100 (range 0.13-0.75) indicated that the low rates of radiographic progression observed among guselkumab-treated patients at earlier time points extended through week 100. Through week 112, 8% (5.8 per 100 patient-years) and 3% (1.9 per 100 patient-years) of the 731 guselkumab-treated patients had a serious adverse event or serious infection, respectively; 1 death occurred (road traffic accident).
CONCLUSION


In biologic-naive PsA patients, guselkumab provided durable improvements in multiple disease domains with no unexpected safety findings through 2 years.",2022,"In biologic-naïve PsA patients, guselkumab provided durable improvements in multiple disease domains with no unexpected safety findings through 2years.","['patients with active psoriatic arthritis (PsA', 'Biologic-naïve Patients with Active Psoriatic Arthritis', 'p19 Subunit of Interleukin-23, Through 2\u2009Years', 'Of 739 randomized and treated patients, 652 (88%) completed treatment through Week100']","['Placebo', 'placebo➔Q4W', 'guselkumab, an IL-23p19-subunit inhibitor', 'placebo', 'Guselkumab']","['arthritis signs/symptoms and extra-articular manifestations', ""ACR components (ACR20/50/70), Investigator's Global Assessment of psoriasis score=0 (IGA=0; indicating complete skin clearance), enthesitis (Leeds Enthesitis Index) and dactylitis (Dactylitis Severity Score) resolution, and changes in PsA-modified van der Heijde-Sharp (vdH-S) radiographic scores"", 'resolution rates', 'serious adverse event or serious infection, respectively; one death occurred (road traffic accident', 'ACR20', 'low rates of radiographic progression', 'Mean changes in PsA-modified vdH-S scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0525037', 'cui_str': 'Genes, CDKN2A'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1311140', 'cui_str': 'IL-23 p19'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C1282952', 'cui_str': 'Enthesitis'}, {'cui': 'C0451148', 'cui_str': 'Enthesitis index'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0557775', 'cui_str': 'Van'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0221706', 'cui_str': 'Road traffic accident'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",739.0,0.29181,"In biologic-naïve PsA patients, guselkumab provided durable improvements in multiple disease domains with no unexpected safety findings through 2years.","[{'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Proton', 'Initials': 'P', 'LastName': 'Rahman', 'Affiliation': 'Memorial University of Newfoundland, St. Johns, Newfoundland, Canada.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine Mt. Sinai, New York, New York.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania, and University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alexa P', 'Initials': 'AP', 'LastName': 'Kollmeier', 'Affiliation': 'Janssen Research & Development, LLC, San Diego, California.'}, {'ForeName': 'Xie L', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development, LLC, San Diego, California.'}, {'ForeName': 'Yusang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Shihong', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Shawi', 'Affiliation': 'Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania.'}, {'ForeName': 'Soumya D', 'Initials': 'SD', 'LastName': 'Chakravarty', 'Affiliation': 'Janssen Scientific Affairs, Horsham, Pennsylvania, and Drexel University College of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.42010']
1167,34719757,Evaluation of anterior segment structures with Scheimpflug camera in patients undergoing sutureless scleral fixation by modified Yamane technique.,"PURPOSE


To evaluate anterior segment parameters in patients undergoing sutureless scleral fixation intraocular lens implantation with the modified Yamane technique (SSF-IOL-MY) by using Scheimpflug camera system.
METHODS


Each group of 25 patients was included for aphakia undergoing SSF-IOL-MY and for senile cataract undergoing uneventful phacoemulsification and intraocular lens implantation (Phaco+IOL). Anterior chamber depth (ACD), iridocorneal angle (ICA), anterior chamber volume (ACV) and keratometric values were evaluated by Scheimpflug camera (Sirius, CSO, Italy) system.
RESULTS


It was seen that the ACD, ICA and ACV display wider structures in patients with SSF-IOL-MY group compared to Phaco+IOL group. However, the ACD (p = 0.828) and ICA (p = 0.219) have not a statistically significant difference, while ACV (p = 0.007) has a statistically significant difference. In terms of keratometric values of the patients, there was no statistically difference in K1, K2 and Kmax values (p = 0.348, p = 0.106, p =0.269, respectively). Although there was no statistically significant difference between the groups in terms of anterior corneal astigmatism, posterior corneal astigmatism was statistically higher in the Phaco+IOL group (p = 0.192, p = 0.031, respectively).
CONCLUSION


SSF-IOL-MY surgery affects anterior segment parameters similar to the Phaco+IOL method, which is the gold standard in cataract surgery. In this surgery, it was approached to the gold standard method in terms of IOL position with the ACD, ACV and ICA values and the results of the corneal incision with the keratometric values.",2022,"Although there was no statistically significant difference between the groups in terms of anterior corneal astigmatism, posterior corneal astigmatism was statistically higher in the Phaco+IOL group (p = 0.192, p = 0.031, respectively).
","['patients undergoing', '25 patients was included for aphakia undergoing SSF-IOL-MY and for senile cataract undergoing', 'patients undergoing sutureless scleral fixation by modified Yamane technique']","['sutureless scleral fixation intraocular lens implantation with the modified Yamane technique (SSF-IOL-MY', 'SSF-IOL', 'uneventful phacoemulsification and intraocular lens implantation (Phaco+IOL', 'Scheimpflug camera']","['anterior corneal astigmatism, posterior corneal astigmatism', 'K1, K2 and Kmax values', 'Anterior chamber depth (ACD), iridocorneal angle (ICA), anterior chamber volume (ACV) and keratometric values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003534', 'cui_str': 'Aphakia'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0036646', 'cui_str': 'Senile cataract'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0179533', 'cui_str': 'Camera'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0229238', 'cui_str': 'Structure of iridocorneal angle'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",25.0,0.0393449,"Although there was no statistically significant difference between the groups in terms of anterior corneal astigmatism, posterior corneal astigmatism was statistically higher in the Phaco+IOL group (p = 0.192, p = 0.031, respectively).
","[{'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Yavuzer', 'Affiliation': 'Van Training and Research Hospital, Ophthalmology Clinic, University of Health Sciences, Van, Turkey. dr.kamilyavuzer@hotmail.com.'}, {'ForeName': 'Beyza', 'Initials': 'B', 'LastName': 'Yavuzer', 'Affiliation': 'Van Training and Research Hospital, Ophthalmology Clinic, University of Health Sciences, Van, Turkey.'}]",International ophthalmology,['10.1007/s10792-021-02107-2']
1168,34666273,Early subthalamic nucleus deep brain stimulation in Parkinson's disease reduces long-term medication costs.,"INTRODUCTION


Subthalamic nucleus (STN) deep brain stimulation (DBS) is recognized as a safe and effective treatment in mid- and advanced-staged Parkinson's disease (PD) that decreases the need for PD medications and their associated costs. This study reports medication costs from the only clinical trial to evaluate DBS in patients with early-stage PD and projects costs through advanced-stage disease.
METHODS


The DBS in early-stage PD pilot was a prospective, single-blind clinical trial that randomized 30 patients with early-stage PD 1:1 to receive bilateral STN-DBS plus optimal drug therapy (ODT) or ODT alone. Subjects who completed the trial participated in an observational follow-up study and were evaluated annually for five years after randomization. PD medication data collected at each study visit were used to calculate and project medication costs (n = 28).
RESULTS


Five-year cumulative medication cost reduction with early DBS+ODT was $28,246. Mean annual medication cost for early DBS+ODT subjects was 2.4 times lower than early ODT subjects (β = 2.4, 95%CI:1.5-3.7, p = 0.0004). Early DBS+ODT is projected to reduce cumulative medication costs by $104,958 over 15 years of disease duration.
CONCLUSION


DBS in early-stage PD may provide long-term medication cost reduction compared to standard care.",2021,"Early DBS+ODT is projected to reduce cumulative medication costs by $104,958 over 15 years of disease duration.
","['30 patients with early-stage PD 1:1 to receive', 'patients with early-stage PD and projects costs through advanced-stage disease', 'Subjects who completed the trial participated in an observational follow-up study and were evaluated annually for five years after randomization']","['DBS', 'bilateral STN-DBS plus optimal drug therapy (ODT) or ODT alone', 'Subthalamic nucleus (STN) deep brain stimulation (DBS']","['Mean annual medication cost', 'cumulative medication costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",30.0,0.101694,"Early DBS+ODT is projected to reduce cumulative medication costs by $104,958 over 15 years of disease duration.
","[{'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Hacker', 'Affiliation': ""Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States; Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, 2201 Children's Way Suite 1221, Nashville, TN 37212. Electronic address: mallory.hacker@vumc.org.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Cannard', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States. Electronic address: grace.cannard@gmail.com.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Turchan', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States. Electronic address: turchanm@gmail.com.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Meystedt', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States. Electronic address: jacqueline.c.meystedt@vanderbilt.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Davis', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States. Electronic address: thomas.l.davis@vumc.org.'}, {'ForeName': 'Fenna', 'Initials': 'F', 'LastName': 'Phibbs', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States. Electronic address: fenna.phibbs@vumc.org.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hedera', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States; Department of Neurology, University of Louisville, Academic Offices, 500 South Preston St., HSC-A Bldg. Suite 113, Louisville, KY 40202, United States. Electronic address: peter.hedera@louisville.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Konrad', 'Affiliation': 'Department of Neurosurgery, Vanderbilt University Medical Center, 1161 21st Ave. So., T4224 Medical Center North, Nashville, TN 37232-2380, United States; Department of Neurosurgery, West Virginia University, Room 4300 HSS, Morgantown, WV 26506, United States. Electronic address: peter.konrad@hsc.wvu.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Charles', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, A-0118 Medical Center North, Nashville, TN 37232, United States. Electronic address: david.charles@vumc.org.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2021.106976']
1169,34721571,Preconditioning with Cathodal High-Definition Transcranial Direct Current Stimulation Sensitizes the Primary Motor Cortex to Subsequent Intermittent Theta Burst Stimulation.,"Noninvasive brain stimulation techniques such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) can induce long-term potentiation-like facilitation, but whether the combination of TMS and tDCS has additive effects is unclear. To address this issue, in this randomized crossover study, we investigated the effect of preconditioning with cathodal high-definition (HD) tDCS on intermittent theta burst stimulation- (iTBS-) induced plasticity in the left motor cortex. A total of 24 healthy volunteers received preconditioning with cathodal HD-tDCS or sham intervention prior to iTBS in a random order with a washout period of 1 week. The amplitude of motor evoked potentials (MEPs) was measured at baseline and at several time points (5, 10, 15, and 30 min) after iTBS to determine the effects of the intervention on cortical plasticity. Preconditioning with cathodal HD-tDCS followed by iTBS showed a greater increase in MEP amplitude than sham cathodal HD-tDCS preconditioning and iTBS at each time postintervention point, with longer-lasting after-effects on cortical excitability. These results demonstrate that preintervention with cathodal HD-tDCS primes the motor cortex for long-term potentiation induced by iTBS and is a potential strategy for improving the clinical outcome to guide therapeutic decisions.",2021,"Preconditioning with cathodal HD-tDCS followed by iTBS showed a greater increase in MEP amplitude than sham cathodal HD-tDCS preconditioning and iTBS at each time postintervention point, with longer-lasting after-effects on cortical excitability.",['24 healthy volunteers'],"['Preconditioning with Cathodal High-Definition Transcranial Direct Current Stimulation Sensitizes', 'cathodal HD-tDCS', 'preconditioning with cathodal high-definition (HD) tDCS', 'transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS', 'preconditioning with cathodal HD-tDCS or sham intervention prior to iTBS']","['cortical excitability', 'amplitude of motor evoked potentials (MEPs', 'MEP amplitude', 'cortical plasticity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1709632', 'cui_str': 'Precondition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}]",24.0,0.0283298,"Preconditioning with cathodal HD-tDCS followed by iTBS showed a greater increase in MEP amplitude than sham cathodal HD-tDCS preconditioning and iTBS at each time postintervention point, with longer-lasting after-effects on cortical excitability.","[{'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Dai', 'Affiliation': 'Rehabilitation Medicine Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': 'Rehabilitation Medicine Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Neuro-Rehabilitation Center, JORU Rehabilitation Hospital, Yixing, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Rehabilitation Medicine Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Wenxiang', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Rehabilitation, Children's Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Jinhui', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jinjin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Rehabilitation Medicine Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yanbing', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Neuro-Rehabilitation Center, JORU Rehabilitation Hospital, Yixing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Rehabilitation Medicine Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Rehabilitation Medicine Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}]",Neural plasticity,['10.1155/2021/8966584']
1170,34723443,Effects of microabrasion association to at-home bleaching on hydrogen peroxide penetration and color change.,"PURPOSE


This study aimed to quantify the penetration of hydrogen peroxide (HP) inside the pulp cavity and color change with two different concentrations of HP to at-home bleaching associated or not with enamel microabrasion (MA).
METHODS


Forty healthy premolars were randomly divided in four groups (n = 10): only HP4%, MA + HP4%, only HP10%, MA + HP10%. The concentration (μg/ml) of HP was assessed using UV-Vis spectrophotometry. The color change (ΔE ab  , ΔE 00  and WI D  ) was evaluated before and one-week after bleaching. Data were evaluated for a two-way ANOVA and the Tukey's test (α = 0.05).
RESULTS


The application of MA increased the amounts of HP inside the pulp chamber when compared to without MA, as well as PH10% when compared to PH4% (p < 0.0001). PH10% showed higher WI D  when compared to PH4%. No significant difference was observed when ΔE ab  , and ΔE 00  were used.
CONCLUSIONS


The enamel MA before at-home bleaching promotes greater penetration of HP, although this procedure did not significantly affect the color change.
CLINICAL SIGNIFICANCE


Since greater penetration of HP into the pulp chamber was detected when home bleaching was applied immediately after MA, the clinician should not apply home bleaching gels in the same session when MA was performed.",2022,"The application of MA increased the amounts of HP inside the pulp chamber when compared to without MA, as well as PH10% when compared to PH4% (p < 0.0001).",['Forty healthy premolars'],"['HP4%, MA\u2009+\u2009HP4%, only HP10%, MA\u2009+\u2009HP10', 'hydrogen peroxide (HP']","['hydrogen peroxide penetration and color change', 'enamel MA']","[{'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]","[{'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0475330', 'cui_str': 'Color change'}, {'cui': 'C0376506', 'cui_str': 'Enamel Microabrasions'}]",40.0,0.00894286,"The application of MA increased the amounts of HP inside the pulp chamber when compared to without MA, as well as PH10% when compared to PH4% (p < 0.0001).","[{'ForeName': 'Laís Giacomini', 'Initials': 'LG', 'LastName': 'Bernardi', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Parana, Brazil.'}, {'ForeName': 'Michael Willian', 'Initials': 'MW', 'LastName': 'Favoreto', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Parana, Brazil.'}, {'ForeName': 'Taynara', 'Initials': 'T', 'LastName': 'de Souza Carneiro', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Parana, Brazil.'}, {'ForeName': 'Christiane Philippini Ferreira', 'Initials': 'CPF', 'LastName': 'Borges', 'Affiliation': 'Department of Chemistry, State University of Ponta Grossa, Parana, Brazil.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Pulido', 'Affiliation': 'Department of Restorative Dentistry, San Francisco de Quito University (USFQ), Quito, Ecuador.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Parana, Brazil.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12830']
1171,34658247,Antithrombotic Therapy for Atrial Fibrillation and Coronary Artery Disease in Patients With Prior Atherothrombotic Disease: A Post Hoc Analysis of the AFIRE Trial.,"Background Among patients with atrial fibrillation and stable coronary artery disease, those with histories of atherothrombotic disease are at high-risk for future ischemic events. This study investigated the efficacy and safety of rivaroxaban monotherapy in patients with atrial fibrillation, coronary artery disease, and histories of atherothrombotic disease. Methods and Results This was a post hoc subanalysis of the AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial. Patients with non-valvular atrial fibrillation and coronary artery disease were recruited and randomized to receive the rivaroxaban monotherapy or combination therapy with rivaroxaban plus antiplatelet drug. For the purpose of this sub-study, participants were divided into 2 subgroups, including the atherothrombosis group (those with histories of myocardial infarction, stroke, and/or peripheral artery disease; n=1052, 47.5%) and non-atherothrombosis group (n=1163, 52.5%). The efficacy end point included cardiovascular events or all-cause death, while the safety end point was major bleeding. Net adverse events consisted of all-cause death, myocardial infarction, stroke, or major bleeding. In the atherothrombosis group, rivaroxaban monotherapy was significantly associated with a lower risk of net adverse events when compared with combination therapy (hazard ratio [HR], 0.50; 95% CI, 0.34-0.74;  P <0.001), with a decrease in both efficacy (HR, 0.68; 95% CI, 0.47-0.99;  P =0.044) and safety (HR, 0.37; 95% CI, 0.19-0.71;  P =0.003) end points. By contrast, there were no differences between treatment outcomes for the non-atherothrombosis group. Conclusions Rivaroxaban monotherapy significantly reduced net adverse events as compared with combination therapy for patients with atrial fibrillation, coronary artery disease, and prior atherothrombotic disease. Registration URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN000016612. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02642419.",2021,"In the atherothrombosis group, rivaroxaban monotherapy was significantly associated with a lower risk of net adverse events when compared with combination therapy (hazard ratio [HR], 0.50; 95% CI, 0.34-0.74;  P <0.001), with a decrease in both efficacy (HR, 0.68; 95% CI, 0.47-0.99;  P =0.044) and safety (HR, 0.37; 95% CI, 0.19-0.71;  P =0.003) end points.","['Patients With Prior Atherothrombotic Disease', 'patients with atrial fibrillation, coronary artery disease, and prior atherothrombotic disease', 'Patients with non-valvular atrial fibrillation and coronary artery disease', 'participants were divided into 2 subgroups, including the atherothrombosis group (those with histories of myocardial infarction, stroke, and/or peripheral artery disease; n=1052, 47.5%) and non-atherothrombosis group (n=1163, 52.5', 'patients with atrial fibrillation, coronary artery disease, and histories of atherothrombotic disease', 'Patients With Stable Coronary Artery Disease) trial', 'patients with atrial fibrillation and stable coronary artery disease, those with histories of atherothrombotic disease']","['Antithrombotic Therapy', 'rivaroxaban monotherapy or combination therapy with rivaroxaban plus antiplatelet drug', 'Rivaroxaban', 'rivaroxaban monotherapy']","['lower risk of net adverse events', 'cardiovascular events or all-cause death, while the safety end point was major bleeding', 'net adverse events', 'death, myocardial infarction, stroke, or major bleeding', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1963943', 'cui_str': 'Atherothrombosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1275835', 'cui_str': 'History of myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C4517802', 'cui_str': '52.5'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet agent'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0865752,"In the atherothrombosis group, rivaroxaban monotherapy was significantly associated with a lower risk of net adverse events when compared with combination therapy (hazard ratio [HR], 0.50; 95% CI, 0.34-0.74;  P <0.001), with a decrease in both efficacy (HR, 0.68; 95% CI, 0.47-0.99;  P =0.044) and safety (HR, 0.37; 95% CI, 0.19-0.71;  P =0.003) end points.","[{'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Matsuzawa', 'Affiliation': 'Division of Cardiology Yokohama City University Medical Center Yokohama Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Division of Cardiology Yokohama City University Medical Center Yokohama Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yasuda', 'Affiliation': 'National Cerebral and Cardiovascular Center Osaka Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kaikita', 'Affiliation': 'Department of Cardiovascular Medicine Graduate School of Medical Sciences Kumamoto University Kumamoto Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Akao', 'Affiliation': 'Department of Cardiology National Hospital Organization Kyoto Medical Center Kyoto Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Ako', 'Affiliation': 'Department of Cardiovascular Medicine Kitasato University School of Medicine Sagamihara Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Matoba', 'Affiliation': 'Department of Cardiovascular Medicine Faculty of Medical Sciences Kyushu University Fukuoka Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Division of Cardiovascular Medicine Toho University Ohashi Medical Center Tokyo Japan.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Miyauchi', 'Affiliation': 'Department of Cardiovascular Medicine Juntendo Tokyo Koto Geriatric Medical Center Tokyo Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology Tokyo Women's Medical University Tokyo Japan.""}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Hirayama', 'Affiliation': 'Department of Cardiology Osaka Police Hospital Osaka Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Matsui', 'Affiliation': 'Department of General Medicine and Primary Care Kumamoto University Hospital Kumamoto Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'National Cerebral and Cardiovascular Center Osaka Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.121.020907']
1172,34728206,Monitors to improve indoor air carbon dioxide concentrations in the hospital: A randomized crossover trial.,"BACKGROUND


Ventilation has emerged as an important strategy to reduce indoor aerosol transmission of coronavirus disease 2019. Indoor air carbon dioxide (CO 2 ) concentrations are a surrogate measure of respiratory pathogen transmission risk.
OBJECTIVES


To determine whether CO 2  monitors are necessary and effective to improve ventilation in hospitals.
METHODS


A randomized, placebo (sham)-controlled, crossover, open label trial. Between February and May 2021, we placed CO 2  monitors in twelve double-bed patient rooms across two geriatric wards. Staff were instructed to open windows, increase the air exchange rate and reduce room crowding to maintain indoor air CO 2  concentrations ≤800 parts per million (ppm).
RESULTS


CO 2  levels increased during morning care and especially in rooms housing couples (rooming-in). The median (interquartile range, IQR) time/day with CO 2  concentration > 800 ppm (primary outcome) was 110 min (IQR 47-207) at baseline, 82 min (IQR 12-226.5) during sham periods, 78 min (IQR 20-154) during intervention periods and 140 min (IQR 19.5-612.5) post-intervention. The intervention period only differed significantly from the post-intervention period (P = 0.02), mainly due to an imbalance in rooming-in. Significant but small differences were observed in secondary outcomes of time/day with CO 2  concentrations > 1000 ppm and daily peak CO 2  concentrations during the intervention vs. baseline and vs. the post-intervention period, but not vs. sham. Staff reported cold discomfort for patients as the main barrier towards increasing ventilation.
DISCUSSION


Indoor air CO 2  concentrations in hospital rooms commonly peaked above recommended levels, especially during morning care and rooming-in. There are many possible barriers towards implementing CO 2  monitors to improve ventilation in a real-world hospital setting. A paradigm shift in hospital infection control towards adequate ventilation is warranted.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04770597.",2022,"The intervention period only differed significantly from the post-intervention period (P = 0.02), mainly due to an imbalance in rooming-in.",[],['placebo'],"['Indoor air carbon dioxide (CO 2 ) concentrations', 'indoor air carbon dioxide concentrations']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0428653', 'cui_str': 'Carbon dioxide concentration'}]",,0.194681,"The intervention period only differed significantly from the post-intervention period (P = 0.02), mainly due to an imbalance in rooming-in.","[{'ForeName': 'Michaël R', 'Initials': 'MR', 'LastName': 'Laurent', 'Affiliation': 'Geriatrics Department, Imelda Hospital, Bonheiden, Belgium; Geriatrics Department, University Hospitals Leuven, Leuven, Belgium. Electronic address: michael.laurent@imelda.be.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Frans', 'Affiliation': 'Department of Medical Microbiology, Imelda Hospital, Bonheiden, Belgium.'}]",The Science of the total environment,['10.1016/j.scitotenv.2021.151349']
1173,34733457,Speckle Tracking Algorithm-Based Ultrasonic Cardiogram in Evaluation of the Efficacy of Dexmedetomidine Combined with Bundle Strategy on Patients with Severe Sepsis.,"The research aimed to study the effect of dexmedetomidine combined with bundle strategy on the cardiac function of patients with severe sepsis through pyramid speckle tracking algorithm-based echocardiography, expected to provide reference for its clinical treatment. 98 patients with severe sepsis or septic shock admitted to the hospital were selected as the research subjects, and they were equally divided into experimental group (dexmedetomidine + bundle strategy) and control group (dexmedetomidine + routine nursing), with 49 in each. Ultrasonic cardiogram examination was performed on patients before and after treatment, and the pyramid-based speckle tracking (PST) algorithm was designed and used. The results showed that the running time of the PST algorithm (105.25 s) was less than that of the BM algorithm (336.41 s), and the difference was statistically significant ( P  < 0.05), and the systolic blood pressure, diastolic blood pressure, left ventricular wall, and heart rate of the experimental group before treatment were not significantly different from those of the control group ( P  > 0.05). The ultrasound index results found that the ejection fraction (EF) and fractional shortening (FS) of the two groups of patients showed a downward trend over time (1-7 days), while the  E / A  ratio showed an upward trend, and the  E / A  ratio of the experimental group was significantly greater than the control group ( P  < 0.05). The systolic blood pressure, diastolic blood pressure, left ventricular wall, and heart rate of the two groups of patients showed a downward trend over time (1-7 days), and the systolic blood pressure, diastolic blood pressure, left ventricular wall, and heart rate of the experimental group were significantly lower than those of the control group ( P  < 0.05). The 28-day mechanical ventilation time (6.97 ± 3.11 days), intensive care unit (ICU) stay time (9.18 ± 2.86 days), and the 28-day mortality rate (15.31%) of the experimental group were lower than those of the control group (6.97 ± 3.11 days; 13.08 ± 2.53 days; 31.95%) ( P  < 0.05). In conclusion, the PST algorithm can effectively improve the quality of echocardiography and assist physicians in clinical evaluation, and dexmedetomidine combined with bundle strategy can stabilize the heart rate and reduce myocardial oxygen consumption in severe sepsis, while effectively shortens the recovery time and improves the overall prognosis.",2021,"The ultrasound index results found that the ejection fraction (EF) and fractional shortening (FS) of the two groups of patients showed a downward trend over time (1-7 days), while the  E / A  ratio showed an upward trend, and the  E / A  ratio of the experimental group was significantly greater than the control group ( P  < 0.05).","['patients with severe sepsis', '98 patients with severe sepsis or septic shock admitted to the hospital were selected as the research subjects', 'Patients with Severe Sepsis']","['dexmedetomidine combined with bundle strategy', 'Dexmedetomidine Combined with Bundle Strategy', 'dexmedetomidine', 'dexmedetomidine\u2009+\u2009bundle strategy) and control group (dexmedetomidine\u2009+\u2009routine nursing', 'pyramid-based speckle tracking (PST) algorithm']","['systolic blood pressure, diastolic blood pressure, left ventricular wall, and heart rate', 'ejection fraction (EF) and fractional shortening (FS', '28-day mortality rate', 'intensive care unit (ICU) stay time', '28-day mechanical ventilation time', 'running time of the PST algorithm', 'heart rate and reduce myocardial oxygen consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428863', 'cui_str': 'Myocardial oxygen consumption'}]",98.0,0.0283779,"The ultrasound index results found that the ejection fraction (EF) and fractional shortening (FS) of the two groups of patients showed a downward trend over time (1-7 days), while the  E / A  ratio showed an upward trend, and the  E / A  ratio of the experimental group was significantly greater than the control group ( P  < 0.05).","[{'ForeName': ""Chang'an"", 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': 'Department of Critical Care Medicine, Affiliated Hospital of Jiangnan University, Wuxi 214062, China.'}, {'ForeName': 'Guan', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Hospitalization Management Section, Affiliated Hongqi Hospital of Mudanjiang Medical University, Mudanjiang 157011, China.'}, {'ForeName': 'Aidong', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Digestive Department, Affiliated Hongqi Hospital of Mudanjiang Medical University, Mudanjiang 157011, China.'}]",Journal of healthcare engineering,['10.1155/2021/7179632']
1174,34736908,"Effect and Safety of Prophylactic Parecoxib for Pain Control of Transarterial Chemoembolization in Liver Cancer: A Single-Center, Parallel-Group, Randomized Trial.","OBJECTIVE


Pain is one of the most common side effects of transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma. The goal of this study is to compare the analgesic effect among celecoxib, parecoxib, and oxycodone in patients undergoing TACE.
METHODS


This prospective study was a randomized, paralleled trial in which 213 patients were enrolled. Patients were assigned at the ratio of 1:1:1 to receive celecoxib, parecoxib, or controlled-release oxycodone 1 hour before TACE (T0) and once every 12 hours for 2 days after TACE. Pain scores, pain intensity, and adverse events in each time interval were evaluated and compared among the 3 groups.
RESULTS


The mean pain score 12 hours after T0 in the parecoxib group (2.8) was lower than that in the celecoxib (4.4; P = .001) and oxycodone groups (4.2; P = .005). The number of patients suffering severe pain was 10 (14.7%) in the parecoxib, 25 (36.8%) in the celecoxib, and 23 (32.9%) in the oxycodone groups (P = .009). Twelve hours after T0, the incidence of grade 3 vomiting in the parecoxib group (2.9%) was significantly lower than that in the oxycodone group (17.1%; P = .006). In the multivariate analysis, nonparecoxib prophylactic analgesia (odds ratio [OR], 4.620; 95% confidence interval [CI], 1.877-11.370; P = .001) as well as embolization of the gallbladder (OR, 8.666; 95% CI, 2.402-31.262; P = .001) and normal liver parenchyma (OR, 3.278; 95% CI, 1.409-7.627; P = .006) were the independent factors of severe pain intensity 12 hours after T0.
CONCLUSION


Parecoxib is superior to oxycodone and celecoxib for pain control with fewer adverse events. Therefore, we recommend parecoxib as a priority strategy for TACE-related pain control.",2022,"In the multivariate analysis, nonparecoxib prophylactic analgesia (odds ratio [OR], 4.620; 95% confidence interval [CI], 1.877-11.370; P = .001) as well as embolization of the gallbladder (OR, 8.666; 95% CI, 2.402-31.262; P = .001) and normal liver parenchyma (OR, 3.278; 95% CI, 1.409-7.627; P = .006) were the independent factors of severe pain intensity 12 hours after T0.
","['Liver Cancer', 'patients undergoing TACE', '213 patients were enrolled', 'patients with unresectable hepatocellular carcinoma']","['oxycodone and celecoxib', 'celecoxib', 'Prophylactic Parecoxib', 'Parecoxib', 'parecoxib', 'Transarterial Chemoembolization', 'transarterial chemoembolization (TACE', 'oxycodone', 'celecoxib, parecoxib, or controlled-release oxycodone 1 hour before TACE', 'celecoxib, parecoxib, and oxycodone']","['normal liver parenchyma', 'number of patients suffering severe pain', 'incidence of grade 3 vomiting', 'analgesic effect', 'mean pain score', 'embolization of the gallbladder', 'Pain scores, pain intensity, and adverse events', 'severe pain intensity']","[{'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0439227', 'cui_str': 'hour'}]","[{'cui': 'C0577059', 'cui_str': 'Liver normal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",213.0,0.159549,"In the multivariate analysis, nonparecoxib prophylactic analgesia (odds ratio [OR], 4.620; 95% confidence interval [CI], 1.877-11.370; P = .001) as well as embolization of the gallbladder (OR, 8.666; 95% CI, 2.402-31.262; P = .001) and normal liver parenchyma (OR, 3.278; 95% CI, 1.409-7.627; P = .006) were the independent factors of severe pain intensity 12 hours after T0.
","[{'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Lyu', 'Affiliation': 'Department of Minimally Invasive Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Department of Breast Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xiaoxian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Zhongshan School of Medicine, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jinfa', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': 'Department of Minimally Invasive Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jibin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Research, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of Minimally Invasive Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: zhaoming@sysucc.org.cn.'}]",Journal of the American College of Radiology : JACR,['10.1016/j.jacr.2021.09.029']
1175,34719004,Metformin in the management of fibrocystic breast disease: a placebo-controlled randomized clinical trial.,"BACKGROUND AND PURPOSE


Fibrocystic disease (FCD) of the breast as a very common health problem in women has estrogen-dependent and proliferative features. No effective management strategy has been validated for this disorder, so far. The anti-hyperglycemic agent metformin has both anti-proliferative and estrogen-suppressing effects. Thus, we investigated metformin as a management strategy for FCD.
METHODS


The study was a double-blind placebo-controlled randomized clinical trial. Premenopausal women with FCD according to history, physical exam and ultrasound, who had measurable microcyst clusters on ultrasound (US) were entered the study. Oral placebo and metformin tablets (500 mg) were used twice daily by participants in the intervention and control groups. Size and number of microcyst clusters on US and the subjective pain score were recorded before and after the intervention.
RESULTS


154 participants were randomly allocated into two groups of 77 interventions and 77 controls. The decrease in size of the largest microcyst cluster in each patient and the mean decrease in number of microcyst clusters were not statistically significant (P = 0.310 and P = 0.637, respectively). However, those microcyst clusters which were ≥ 14 mm became significantly smaller after metformin use (P = 0.006). Additionally, in the subset of participants with pain at baseline, a larger proportion in the intervention group experienced at least 50% reduction in pain score (63.8% (30/47) in the intervention vs. 44.2% (19/43) in the placebo groups, P = 0.031).
CONCLUSION


Our study showed that metformin might be effective in the management of FCD. Further studies are proposed for confirmation of this subject.",2021,14 mm became significantly smaller after metformin use (P = 0.006).,"['Premenopausal women with FCD according to history, physical exam and ultrasound, who had measurable microcyst clusters on ultrasound (US) were entered the study', 'fibrocystic breast disease', '154 participants']","['Oral placebo and metformin tablets', 'placebo', 'Metformin', 'metformin']","['number of microcyst clusters', 'pain score', 'size of the largest microcyst cluster', 'Size and number of microcyst clusters on US and the subjective pain score']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0016034', 'cui_str': 'Fibrocystic disease of breast'}, {'cui': 'C5191279', 'cui_str': '154'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",154.0,0.148228,14 mm became significantly smaller after metformin use (P = 0.006).,"[{'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Alipour', 'Affiliation': 'Breast Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadith', 'Initials': 'H', 'LastName': 'Rastad', 'Affiliation': 'Cardiovascular Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Azin', 'Initials': 'A', 'LastName': 'Saberi', 'Affiliation': ""Department of Surgery, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Faiz', 'Affiliation': 'Department of Endocrinology and Metabolism, Arash Women Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Maleki-Hajiagha', 'Affiliation': ""Research Development Center, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Abedi', 'Affiliation': 'Breast Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran. abedi.mahboobeh@yahoo.com.'}]","Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences",['10.1007/s40199-021-00424-6']
1176,34725453,Outcomes in adolescent and young adult patients (16 to 30 years) compared to younger patients treated for high-risk B-lymphoblastic leukemia: report from Children's Oncology Group Study AALL0232.,"Adolescent and young adult (AYA) patients 16-30 years old with high-risk acute lymphoblastic leukemia (HR-ALL) have inferior outcomes compared to younger HR-ALL patients. AALL0232 was a Phase 3 randomized Children's Oncology Group trial for newly diagnosed HR B-ALL (1-30 years). Between 2004 and 2011, 3154 patients enrolled with 3040 eligible and evaluable for induction. AYA patients comprised 20% of patients (16-21 years, n = 551; 22-30 years, n = 46). 5-year event-free survival and overall survival was 65.4 ± 2.2% and 77.4 ± 2.0% for AYA patients compared to 78.1 ± 0.9% and 87.3 ± 0.7% for younger patients (p < 0.0001). Five-year cumulative incidence of relapse was 18.5 ± 1.7% for AYA patients and 13.5 ± 0.7% for younger patients (p = 0.006), largely due to increased marrow relapses (14.0 ± 1.5% versus 9.1 ± 0.6%; p < 0.0001). Additionally, induction failure rate was higher in AYA (7.2 ± 1.1% versus 3.5 ± 0.4%; p < 0.001) and post-induction remission deaths were significantly higher in AYA (5.7 ± 1.0% versus 2.4 ± 0.3%; p < 0.0001). AALL0232 enrolled the largest number of AYA B-ALL patients to date, demonstrating significantly inferior survival and greater rates of treatment-related toxicities compared to younger patients. Although treatment intensification has improved outcomes in younger patients, they have not been associated with the same degree of improvement for older patients.",2022,5-year event-free survival and overall survival was 65.4 ± 2.2% and 77.4 ± 2.0% for AYA patients compared to 78.1 ± 0.9% and 87.3 ± 0.7% for younger patients (p < 0.0001).,"['Between 2004 and 2011, 3154 patients enrolled with 3040 eligible and evaluable for induction', 'Adolescent and young adult (AYA) patients 16-30 years old with high-risk acute lymphoblastic leukemia (HR-ALL', 'younger patients']",['AALL0232'],"['induction failure rate', 'marrow relapses', 'post-induction remission deaths', 'inferior survival and greater rates of treatment-related toxicities', '5-year event-free survival and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],"[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",3154.0,0.101345,5-year event-free survival and overall survival was 65.4 ± 2.2% and 77.4 ± 2.0% for AYA patients compared to 78.1 ± 0.9% and 87.3 ± 0.7% for younger patients (p < 0.0001).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Burke', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Wisconsin, Milwaukee, WI, USA. mmburke@mcw.edu.""}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Biostatistics, Colleges of Medicine and Public Health & Health Professions, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Wanda L', 'Initials': 'WL', 'LastName': 'Salzer', 'Affiliation': 'U.S. Army Medical Research and Materiel Command, Fort Detrick, MD, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Raetz', 'Affiliation': 'Department of Pediatrics, Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY, USA.'}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Rabin', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': 'Department of Pathology, The Ohio State University School of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Gastier-Foster', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Borowitz', 'Affiliation': 'Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Brent L', 'Initials': 'BL', 'LastName': 'Wood', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Naomi J', 'Initials': 'NJ', 'LastName': 'Winick', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Department of Pediatrics, Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'Mignon L', 'Initials': 'ML', 'LastName': 'Loh', 'Affiliation': ""Department of Pediatrics, Benioff Children's Hospital and the Helen Diller Family Comprehensive Cancer Center, University of California at San Francisco, San Francisco, CA, USA.""}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Larsen', 'Affiliation': ""Department of Pediatrics, Maine Children's Cancer Program, Scarborough, ME, USA.""}]",Leukemia,['10.1038/s41375-021-01460-6']
1177,34699409,"Effects of vibegron on ambulatory blood pressure in patients with overactive bladder: results from a double-blind, placebo-controlled trial.","OBJECTIVES


To characterize the blood pressure (BP) profile of the new β3-adrenergic receptor agonist, vibegron, in patients with overactive bladder.
METHODS


Patients were randomized to once-daily vibegron 75 mg or placebo for 28 days and underwent ambulatory BP monitoring. The primary endpoint was change from baseline (CFB) to day 28 in mean daytime ambulatory systolic BP (SBP). Secondary endpoints were CFB in mean 24-h SBP and in mean daytime and mean 24-h ambulatory diastolic BP (DBP) and heart rate (HR). Safety was assessed through adverse event reporting.
RESULTS


Of 214 patients randomized, 96 receiving vibegron and 101 receiving placebo had evaluable baseline and day 28 measurements. Overall, 39.6 and 30.7% of patients receiving vibegron and placebo, respectively, had preexisting hypertension. The least squares mean difference (LSMD; 90% confidence interval) between vibegron and placebo in CFB in mean daytime SBP was 0.8 (-0.9, 2.5) mmHg. LSMD in CFB in mean daytime DBP and HR was 0.0 mmHg and 0.9 bpm, respectively. No significant differences between treatments were seen in CFB in mean 24-h SBP (LSMD, 0.6 mmHg), DBP (-0.2 mmHg) or HR (1.0 bpm). The most common treatment-emergent adverse event was hypertension, with rates comparable between groups [vibegron: n = 5 (4.7%); placebo: n = 4 (3.7%)]. One patient receiving vibegron took a prohibited medication (phentermine) known to increase BP.
CONCLUSIONS


Once-daily vibegron had no statistically significant or clinically relevant effects on BP or HR.",2022,"No significant differences between treatments were seen in CFB in mean 24-h SBP (LSMD, 0.6 mmHg), DBP (-0.2 mmHg) or HR (1.0 bpm).","['patients with overactive bladder', '214 patients randomized', 'Patients']","['placebo', 'vibegron', 'vibegron 75 mg or placebo', 'ambulatory BP monitoring']","['ambulatory blood pressure', 'CFB in mean 24-h SBP and in mean daytime and mean 24-h ambulatory diastolic BP (DBP) and heart rate (HR', 'BP or HR', 'blood pressure (BP) profile', 'mean daytime SBP', 'mean daytime DBP and HR', 'preexisting hypertension', 'CFB in mean 24-h SBP (LSMD, 0.6 mmHg), DBP', 'change from baseline (CFB) to day\u200928 in mean daytime ambulatory systolic BP (SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}]","[{'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",214.0,0.376538,"No significant differences between treatments were seen in CFB in mean 24-h SBP (LSMD, 0.6 mmHg), DBP (-0.2 mmHg) or HR (1.0 bpm).","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Weber', 'Affiliation': 'State University of New York Downstate College of Medicine, Brooklyn, New York, USA.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Haag-Molkenteller', 'Affiliation': 'Urovant Sciences, Irvine, California, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'King', 'Affiliation': 'Urovant Sciences, Irvine, California, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': 'Apex Biostatistics, Inc, Apex, North Carolina, USA.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Mudd', 'Affiliation': 'Urovant Sciences, Irvine, California, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'White', 'Affiliation': 'Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, Connecticut, USA.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000572']
1178,34729654,"ASO Author Reflections: A Randomized Controlled Trial to Address the Effect of Prehabilitation During Neoadjuvant Therapy on Cardiopulmonary Fitness, Muscle Mass and Quality of Life in the Oesophagogastric Cancer Patient.",,2022,,['ASO Author Reflections'],['Prehabilitation'],"['Cardiopulmonary Fitness, Muscle Mass and Quality of Life']","[{'cui': 'C0003436', 'cui_str': 'Antistreptolysin O'}, {'cui': 'C3812881', 'cui_str': 'Author'}]","[{'cui': 'C5192101', 'cui_str': 'Prehabilitation'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.250588,,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK. sophieallen@doctors.org.uk.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Sultan', 'Affiliation': 'Regional Oesophago-Gastric Unit, Royal Surrey County Hospital, Guildford, UK.'}]",Annals of surgical oncology,['10.1245/s10434-021-11014-w']
1179,34730267,"RE: Modification of oxytocin use through a coaching-based intervention based on the WHO Safe Childbirth Checklist in Uttar Pradesh, India: a secondary analysis of a cluster randomised controlled trial.",,2022,,[],['oxytocin'],[],[],"[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",[],,0.18613,,"[{'ForeName': 'Avir', 'Initials': 'A', 'LastName': 'Sarkar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Venkatappa', 'Affiliation': 'Department of Obstetrics and Gynaecology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Isha', 'Initials': 'I', 'LastName': 'Wadhawan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fortis Escorts Hospital, Faridabad, India.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16955']
1180,34730535,"A Mobile App to Enhance Behavioral Activation Treatment for Substance Use Disorder: App Design, Use, and Integration Into Treatment in the Context of a Randomized Controlled Trial.","BACKGROUND


Group-based formats typically used in low-resource substance use disorder (SUD) treatment settings result in little individual attention to help reinforce and guide skill use, which may contribute to poor posttreatment outcomes. Smartphone apps offer a convenient, user-friendly, and cost-effective tool that can extend the reach of effective SUD treatments. A smartphone app was developed and integrated into a group-based, brief behavioral activation (BA) treatment for SUD to increase engagement in treatment skills outside clinician-administered sessions.
OBJECTIVE


This study aims to describe the features of the app and its use and integration into treatment, report the participants' self-reported feasibility and acceptability of the app, and discuss challenges and provide recommendations for future smartphone app integration into behavioral treatments for SUD.
METHODS


A total of 56 individuals recruited from intensive outpatient SUD treatment received a smartphone-enhanced BA treatment, the Life Enhancement Treatment for Substance Use. Self-reported weekly app use and reasons for nonuse were assessed at posttreatment and at 1- and 3-month follow-ups. In addition, 2-tailed t tests and chi-square tests compared the self-reported use of each app component and overall app use over time.
RESULTS


Participant feedback suggested that the integration of the smartphone app into the Life Enhancement Treatment for Substance Use was feasible and well accepted, and participants found the app useful for planning value-based activities outside of sessions. Self-reported app engagement decreased over the follow-up period: 72% (39/54) of participants reported using the app at posttreatment, decreasing to 69% (37/54) at the 1-month follow-up and 37% (20/54) at the 3-month follow-up. Participants reported forgetting to use the app as a primary reason for nonuse.
CONCLUSIONS


This study provides support for the feasibility and acceptability of smartphone-enhanced BA treatment, offering promise for future research testing the integration of technology into SUD treatment. Design decisions may help streamline smartphone integration into treatment, for example, allowing participants to download the treatment app on their own phones or use a low-cost study smartphone (or offering both options). Long-term app engagement may be increased via built-in reminders, alerts, and in-app messages.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02707887; https://clinicaltrials.gov/ct2/show/study/NCT02707887.",2021,"Self-reported app engagement decreased over the follow-up period: 72% (39/54) of participants reported using the app at posttreatment, decreasing to 69% (37/54) at the 1-month follow-up and 37% (20/54) at the 3-month follow-up.",['56 individuals recruited from intensive outpatient SUD treatment received a'],"['smartphone-enhanced BA treatment', 'smartphone-enhanced BA treatment, the Life Enhancement Treatment for Substance Use']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]",[],56.0,0.0910747,"Self-reported app engagement decreased over the follow-up period: 72% (39/54) of participants reported using the app at posttreatment, decreasing to 69% (37/54) at the 1-month follow-up and 37% (20/54) at the 3-month follow-up.","[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Paquette', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Dillon T', 'Initials': 'DT', 'LastName': 'Rubalcava', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Anand', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Stacey B', 'Initials': 'SB', 'LastName': 'Daughters', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}]",JMIR formative research,['10.2196/25749']
1181,34739648,Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA: Rationale and Study Design for the RIC-AFRICA Trial.,"PURPOSE


Despite evidence of myocardial infarct size reduction in animal studies, remote ischaemic conditioning (RIC) failed to improve clinical outcomes in the large CONDI-2/ERIC-PPCI trial. Potential reasons include that the predominantly low-risk study participants all received timely optimal reperfusion therapy by primary percutaneous coronary intervention (PPCI). Whether RIC can improve clinical outcomes in higher-risk STEMI patients in environments with poor access to early reperfusion or PPCI will be investigated in the RIC-AFRICA trial.
METHODS


The RIC-AFRICA study is a sub-Saharan African multi-centre, randomized, double-blind, sham-controlled clinical trial designed to test the impact of RIC on the composite endpoint of 30-day mortality and heart failure in 1200 adult STEMI patients without access to PPCI. Randomized participants will be stratified by whether or not they receive thrombolytic therapy within 12 h or arrive outside the thrombolytic window (12-24 h). Participants will receive either RIC (four 5-min cycles of inflation [20 mmHg above systolic blood pressure] and deflation of an automated blood pressure cuff placed on the upper arm) or sham control (similar protocol but with low-pressure inflation of 20 mmHg and deflation) within 1 h of thrombolysis and applied daily for the next 2 days. STEMI patients arriving greater than 24 h after chest pain but within 72 h will be recruited to participate in a concurrently running independent observational arm.
CONCLUSION


The RIC-AFRICA trial will determine whether RIC can reduce rates of death and heart failure in higher-risk sub-optimally reperfused STEMI patients, thereby providing a low-cost, non-invasive therapy for improving health outcomes.",2021,"PURPOSE


Despite evidence of myocardial infarct size reduction in animal studies, remote ischaemic conditioning (RIC) failed to improve clinical outcomes in the large CONDI-2/ERIC-PPCI trial.","['1200 adult STEMI patients without access to PPCI', 'STEMI Patients in Sub-Saharan AFRICA', 'STEMI patients arriving greater than 24 h after chest pain but within 72 h will be recruited to participate in a concurrently running independent observational arm']","['RIC (four 5-min cycles of inflation [20 mmHg above systolic blood pressure] and deflation of an automated blood pressure cuff placed on the upper arm) or sham\xa0control (similar protocol but with low-pressure inflation of 20 mmHg and deflation', 'thrombolytic therapy', 'RIC', 'reperfusion therapy by primary percutaneous coronary intervention (PPCI']","['30-day mortality and heart failure', 'rates of death and heart failure']","[{'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1200.0,0.58147,"PURPOSE


Despite evidence of myocardial infarct size reduction in animal studies, remote ischaemic conditioning (RIC) failed to improve clinical outcomes in the large CONDI-2/ERIC-PPCI trial.","[{'ForeName': 'Kishal', 'Initials': 'K', 'LastName': 'Lukhna', 'Affiliation': 'Division of Cardiology, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Hausenloy', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK.'}, {'ForeName': 'Abdelbagi Sidahmed', 'Initials': 'AS', 'LastName': 'Ali', 'Affiliation': 'Sudan Heart Centre, Khartoum, Sudan.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Bajaber', 'Affiliation': 'Mombasa hospital, Mombasa, Kenya.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Calver', 'Affiliation': 'Tshepong Hospital, Klerksdorp, South Africa.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Mutyaba', 'Affiliation': 'Division of Cardiology, Charlotte Maxeke Johannesburg Academic Hospital and University of Witwatersrand, Johannesburg, Gauteng, South Africa.'}, {'ForeName': 'Awad Abdalla', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Al Shaab Teaching Hospital, Khartoum, Sudan.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kiggundu', 'Affiliation': 'Uganda Heart Institute, Kampala, Uganda.'}, {'ForeName': 'Chishala', 'Initials': 'C', 'LastName': 'Chishala', 'Affiliation': 'Division of Cardiology, Greys Hospital and University of KwaZulu Natal, Pietermaritzburg, South Africa.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Variava', 'Affiliation': 'Tshepong Hospital, Klerksdorp, South Africa.'}, {'ForeName': 'Ehab Ali', 'Initials': 'EA', 'LastName': 'Elmakki', 'Affiliation': 'Aliaa Specialist Hospital, Omdurman, Sudan.'}, {'ForeName': 'Elijah', 'Initials': 'E', 'LastName': 'Ogola', 'Affiliation': 'Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Eltayeb', 'Initials': 'E', 'LastName': 'Hamid', 'Affiliation': 'Al Shaab Teaching Hospital, Khartoum, Sudan.'}, {'ForeName': 'Emmy', 'Initials': 'E', 'LastName': 'Okello', 'Affiliation': 'Uganda Heart Institute, Kampala, Uganda.'}, {'ForeName': 'Isam', 'Initials': 'I', 'LastName': 'Gaafar', 'Affiliation': 'Omdurman Accident and Emergency Hospital, Khartoum, Sudan.'}, {'ForeName': 'Keiran', 'Initials': 'K', 'LastName': 'Mwazo', 'Affiliation': 'Coast General Teaching Hospital, Mombasa, Kenya.'}, {'ForeName': 'Makoali', 'Initials': 'M', 'LastName': 'Makotoko', 'Affiliation': 'Division of Cardiology, Universitas Academic Hospital, Bloemfontein, South Africa.'}, {'ForeName': 'Mergan', 'Initials': 'M', 'LastName': 'Naidoo', 'Affiliation': 'Division of Family Medicine, Wentworth Hospital, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Mohamed Elhadi', 'Initials': 'ME', 'LastName': 'Abdelhameed', 'Affiliation': 'Al Saha Specialised Hospital, Khartoum, Sudan.'}, {'ForeName': 'Motasim', 'Initials': 'M', 'LastName': 'Badri', 'Affiliation': 'Department of Epidemiology and Biostatistics, King Saud Bin Abdulaziz University for Health Sciences, University of Riyadh, Riyadh, Saudi Arabia.'}, {'ForeName': 'Nasief', 'Initials': 'N', 'LastName': 'van der Schyff', 'Affiliation': 'Victoria Hospital, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Omaima', 'Initials': 'O', 'LastName': 'Abozaid', 'Affiliation': 'Medani Heart Centre, Wad Medani, Sudan.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Xafis', 'Affiliation': 'Victoria Hospital, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Giesz', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Gould', 'Affiliation': 'Department of Medicine, George Hospital, George, South Africa.'}, {'ForeName': 'Waldo', 'Initials': 'W', 'LastName': 'Welgemoed', 'Affiliation': 'Department of Medicine, George Hospital, George, South Africa.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Walker', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK.'}, {'ForeName': 'Mpiko', 'Initials': 'M', 'LastName': 'Ntsekhe', 'Affiliation': 'Division of Cardiology, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Derek M', 'Initials': 'DM', 'LastName': 'Yellon', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK. d.yellon@ucl.ac.uk.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-021-07283-y']
1182,34724670,Optimize Initial Freezing Time of Transbronchial Cryobiopsy for the Diagnosis of Interstitial Lung Disease: A Prospective Randomized Parallel Group Study.,"BACKGROUND


Transbronchial cryobiopsy (TBCB) is increasingly being identified as a potential alternative for the diagnosis of interstitial lung disease (ILD). The specimen size of TBCB is positively related to the freezing time. However, the proper initial freezing time for the clinical application of TBCB in ILD remains unknown.
METHODS


A prospective randomized parallel group study was employed to investigate ILD patients with unclear diagnosis, who were admitted to the First Affiliated Hospital of Guangzhou Medical University from May 2019 to October 2020 and required TBCB. All patients were randomly divided into 4 groups according to the different freezing times of TBCB: 3 s, 4 s, 5 s, and 6 s groups. All operations were performed under intravenous anesthesia with endotracheal intubation, 60-65 bar pressure of freezing gas source, and 1.9-mm cryoprobe. Compare differences among groups in specimen size, complications, pathological diagnosis efficiency, and multidisciplinary discussion (MDD) diagnostic efficiency.
RESULTS


A total of 100 patients were recruited and randomly assigned into 4 groups (n = 25 each group). The specimen sizes of TBCB in ILD were positively correlated with the freezing time (r = 0.639, p < 0.05). None of the patients experienced Grade 3 severe bleeding. Pneumothorax occurred in 1 patient in the 4 s, 5 s, and 6 s groups, respectively. The diagnostic yield of MDD in the 3 s, 4 s, 5 s, and 6 s groups were 64%, 88%, 88%, and 96%, respectively (p < 0.05), but showing no significant differences among 4 s, 5 s, and 6 s groups.
CONCLUSIONS


The specimen size and diagnostic efficiency of TBCB in ILD increased with a longer freezing time. When the freezing gas pressure is 60-65 bar, we recommended 4 s as the initial freezing time of TBCB, and this time is associated with high diagnostic efficiency and low incidence of complications.",2022,None of the patients experienced Grade 3 severe bleeding.,"['Interstitial Lung Disease', 'A total of 100 patients', 'ILD patients with unclear diagnosis, who were admitted to the First Affiliated Hospital of Guangzhou Medical University from May 2019 to October 2020 and required TBCB']","['Transbronchial cryobiopsy (TBCB', 'Transbronchial Cryobiopsy']","['specimen size and diagnostic efficiency of TBCB in ILD', 'Grade 3 severe bleeding', 'specimen sizes of TBCB in ILD', 'Pneumothorax', 'diagnostic yield of MDD', 'specimen size, complications, pathological diagnosis efficiency, and multidisciplinary discussion (MDD) diagnostic efficiency']","[{'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}]","[{'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}]","[{'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",100.0,0.0419321,None of the patients experienced Grade 3 severe bleeding.,"[{'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China, xiaobo-win@163.com.'}, {'ForeName': 'Yongshun', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Huizhou Municipal Central Hospital, Huizhou, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Han', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Weiquan', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Difei', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Department of anesthesiology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'The Center of Respiratory Pathology, Guangzhou Institute of Respiratory Health, Guangzhou, China.'}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Shiyue', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}]",Respiration; international review of thoracic diseases,['10.1159/000519502']
1183,34728252,Patient-reported outcome measures (PROMs) comparing digital and conventional workflows for treatment with posterior single-unit implant restorations: A randomized controlled trial.,"OBJECTIVES


The aim of this randomized controlled trial (RCT) was to analyze patient-reported outcome measures (PROMs) of prosthetic therapy with monolithic implant crowns in completely digital workflows (test) with intraoral optical scanning (IOS) and conventional workflows (control) with conventional impressions. Secondary, an objective evaluation of the final implant restorations was performed using the Functional Implant Prosthodontic Score (FIPS).
MATERIALS AND METHODS


Forty patients who required an implant-supported single crown on posterior regions were randomly divided into test (n = 20) and control (n = 20) groups for impression taking. Each group was then equally separated into two subgroups according to the restorative material used: lithium disilicate (LS2, N!CE®, Straumann AG, Basel, Switzerland) or polymer-infiltrated ceramic networks (PICN, Enamic®, Vita, Bad Säckingen, Germany). Patient satisfaction was evaluated using PROM questionnaires with visual analog scales (VAS) after impression-taking and 1 week after prosthetic delivery. Patient satisfaction with the impression technique was assessed in six domains: length, comfort, anxiety, taste, nausea, and pain, whereas patient satisfaction with the final restoration was assessed in four domains: overall treatment outcome, functionality, esthetics, and cleanability. In addition, the final implant restorations were objectively assessed by an independent prosthodontist using the FIPS. Mann-Whitney U test was used to analyze the defined outcomes. Statistical analysis was completed with a level of significance set at α=0.05.
RESULTS


PROMs focusing on the impression technique demonstrated higher levels of patient satisfaction for IOS compared to conventional impressions, especially in terms of ""taste irritation"" (p = 0.036); whereas no significant differences were found between both restorative CAD/CAM-materials. Mean FIPS values demonstrated similar results among subgroups.
CONCLUSIONS


Within the limitation of this study, both completely digital and conventional protocols provided great levels of patient satisfaction in implant rehabilitation of single-tooth gaps in posterior sites with monolithic implant crowns. The restorative material, LS2 versus PICN, does not impact patient satisfaction with their treatment. However, a long-term follow up is needed to draw more specific conclusions on patient satisfaction with the restorations.",2022,"RESULTS


PROMs focusing on the impression technique demonstrated higher levels of patient satisfaction for IOS compared to conventional impressions, especially in terms of ""taste irritation"" (p=0.036); whereas no significant differences were found between both restorative CAD/CAM-materials.",['Forty patients who required an implant-supported single crown on posterior regions'],"['digital & conventional workflows', 'lithium disilicate (LS2, N!CE®, Straumann AG, Basel, Switzerland) or polymer-infiltrated ceramic networks (PICN, Enamic®, Vita, Bad\xa0Säckingen, Germany', 'intraoral optical scanning (IOS) and conventional workflows (control) with conventional impressions', 'posterior single-unit implant restorations']","['six domains: length, comfort, anxiety, taste, nausea, and pain, whereas patient satisfaction with the final restoration', 'patient satisfaction for IOS', 'functionality, esthetics, and cleanability', 'Functional Implant Prosthodontic Score (FIPS', 'PROM questionnaires with visual analog scales (VAS', 'taste irritation', 'Patient satisfaction', 'Mean FIPS values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C4308553', 'cui_str': 'ENAMIC'}, {'cui': 'C0373745', 'cui_str': 'Vitamin A measurement'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0033590', 'cui_str': 'Prosthodontics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015944', 'cui_str': 'Premature rupture of membranes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",40.0,0.0814404,"RESULTS


PROMs focusing on the impression technique demonstrated higher levels of patient satisfaction for IOS compared to conventional impressions, especially in terms of ""taste irritation"" (p=0.036); whereas no significant differences were found between both restorative CAD/CAM-materials.","[{'ForeName': 'Chatchai', 'Initials': 'C', 'LastName': 'Kunavisarut', 'Affiliation': 'Department of Advanced General Dentistry, Mahidol University, Bangkok, Thailand. Electronic address: Chatchai.kun@mahidol.ac.th.'}, {'ForeName': 'Worapat', 'Initials': 'W', 'LastName': 'Jarangkul', 'Affiliation': 'Master of Science Program in Implant Dentistry, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Suchaya', 'Initials': 'S', 'LastName': 'Pornprasertsuk-Damrongsri', 'Affiliation': 'Department of Oral and Maxillofacial Radiology, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Joda', 'Affiliation': 'Department of Reconstructive Dentistry, University Center for Dental Medicine Basel, University of Basel, Basel, Switzerland.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103875']
1184,34656656,Artificial intelligence for caries detection: Randomized trial.,"OBJECTIVES


We aimed to assess the impact of an artificial intelligence (AI)-based diagnostic-support software for proximal caries detection on bitewing radiographs.
METHODS


A cluster-randomized cross-over controlled trial was conducted. A commercially available software employing a fully convolutional neural network for caries detection (dentalXrai Pro, dentalXrai Ltd.) was randomly employed by 22 dentists, supporting their caries detection on 20 bitewings randomly chosen from a pool of 140 bitewings, with 10 bitewings randomly being supported by AI and 10 not. The reference test had been established by 4 + 1 independent experts in a pixelwise fashion. Caries was subgrouped as enamel, early dentin and advanced dentin caries, and accuracy and treatment decisions for each caries lesion assessed.
RESULTS


Dentists with AI showed a significantly higher mean (95% CI) area under the Receiver-Operating-Characteristics curve (0.89; 0.87-0.90) than those without AI (0.85; 0.83-0.86; p<0.05), mainly as their sensitivity was significantly higher (0.81; 0.74-0.87 compared with 0.72; 0.64-0.79; p<0.05) while the specificity was not significantly affected (p>0.05). This increase in sensitivity was found for enamel, but not early or advanced dentin lesions. Higher sensitivity came with an increase in non-invasive, but also invasive treatment decisions (p<0.05).
CONCLUSION


AI can increase dentists' diagnostic accuracy but may also increase invasive treatment decisions.
CLINICAL SIGNIFICANCE


AI can increase dentists' diagnostic accuracy, mainly via increasing their sensitivity for detecting enamel lesions, but may also increase invasive therapy decisions. Differences in the effects of AI for different dentists should be explored, and dentists should be guided as to which therapy to choose when detecting caries lesions using AI support.",2021,"Higher sensitivity came with an increase in non-invasive, but also invasive treatment decisions (p<0.05).
",[],['artificial intelligence (AI)-based diagnostic-support software'],"['sensitivity', ""dentists' diagnostic accuracy""]",[],"[{'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0749111,"Higher sensitivity came with an increase in non-invasive, but also invasive treatment decisions (p<0.05).
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mertens', 'Affiliation': 'Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany; Department of Operative and Preventive Dentistry, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Krois', 'Affiliation': 'Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany.'}, {'ForeName': 'Anselmo Garcia', 'Initials': 'AG', 'LastName': 'Cantu', 'Affiliation': 'Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany.'}, {'ForeName': 'Lubaina T', 'Initials': 'LT', 'LastName': 'Arsiwala', 'Affiliation': 'Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Schwendicke', 'Affiliation': 'Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany. Electronic address: falk.schwendicke@charite.de.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103849']
1185,34731434,Acupoint Injection Decreases Anesthetic Cosumption during Combined Spinal-Epidural and Patient-Controlled Epidural Labor Analgesia.,"OBJECTIVE


To explore if acupoint injection can improve analgesic effects or delivery outcomes in parturients who received combined spinal-epidural analgesia (CSEA) and patient-controlled epidural analgesia (PCEA) for labor analgesia.
METHODS


A total of 307 participants were prospectively collected from July 2017 to December 2019. The participants were randomized into the combined acupoint injection with CSEA plus PCEA group (AICP group, n=168) and CSEA plus PCEA group (CP group, n=139) for labor analgesia using a random number table. Both groups received CSEA plus PCEA at cervical dilation 3 cm during labor process, and parturients of the AICP group were implemented acupoint injection for which bilateral acupoint of Zusanli (ST 36) and Sanyinjiao (SP 6) were selected in addition. The primary outcome was Visual Analogue Scale (VAS) score, and the secondary outcomes were obstetric outcomes and requirement of anesthetics doses. Safety evaluations were performed after intervention.
RESULTS


The VAS scores were significantly lower in the AICP group than in the CP group at 10, 30, 60, and 120 min after labor analgesia (all P<0.05). The latent phase of the AICP group was shorter than that of the CP group (P<0.05). There were less additional anesthetics consumption, lower incidences of uterine atony, fever, pruritus and urinary retention in the AICP group than those in the CP group (all P<0.05).
CONCLUSION


Acupoint injection combined CSEA plus PCEA for labor analgesia can decrease the anesthetic consumption, improve analgesic quality, and reduce adverse reactions in the parturients. (Registration No. ChiMCTR-2000003120).",2022,The latent phase of the AICP group was shorter than that of the CP group (P<0.05).,"['parturients who received', 'A total of 307 participants were prospectively collected from July 2017 to December 2019']","['CSEA plus PCEA', 'labor analgesia', 'combined spinal-epidural analgesia (CSEA) and patient-controlled epidural analgesia (PCEA', 'AICP', 'Acupoint Injection', 'combined acupoint injection with CSEA plus PCEA', 'acupoint injection', 'CP']","['Visual Analogue Scale (VAS) score, and the secondary outcomes were obstetric outcomes and requirement of anesthetics doses', 'additional anesthetics consumption, lower incidences of uterine atony, fever, pruritus and urinary retention', 'VAS scores', 'adverse reactions', 'analgesic quality']","[{'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042135', 'cui_str': 'Uterine inertia'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",307.0,0.137942,The latent phase of the AICP group was shorter than that of the CP group (P<0.05).,"[{'ForeName': 'Min-Li', 'Initials': 'ML', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510630, China.'}, {'ForeName': 'Chang-Ping', 'Initials': 'CP', 'LastName': 'Fang', 'Affiliation': 'Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510630, China.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Zhao', 'Affiliation': 'Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510630, China.'}, {'ForeName': 'Zi-Jing', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510630, China.'}, {'ForeName': 'Shu-Zhen', 'Initials': 'SZ', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510630, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yi', 'Affiliation': 'Medical College of Acupuncture-Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, 510006, China.'}, {'ForeName': 'Shang-Rong', 'Initials': 'SR', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, China.'}, {'ForeName': 'Ling-Ling', 'Initials': 'LL', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510630, China. wulingling2003@163.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-021-3501-8']
1186,34717532,Comparison of the hemodynamic response of dexmedetomidine versus additional intravenous lidocaine with propofol during tracheal intubation: a randomized controlled study.,"BACKGROUND


Laryngoscopy and tracheal intubation are strong stimuli that cause a reflex increase in blood pressure (BP), heart rate (HR), and serum catecholamine level. These can lead to myocardial infarction or cerebrovascular accidents. The purpose of this study is to compare the efficacy of dexmedetomidine and lidocaine combined with propofol in attenuating the hemodynamic response following laryngoscopy and endotracheal intubation.
METHODS


This study was a randomized controlled study and adhered to the CONSORT guidelines. One-hundred and six patients undergoing elective general anesthesia with endotracheal intubation were divided randomly into two groups. Group D received dexmedetomidine (1 μg kg - 1 ) before induction. Group LP received lidocaine (1.5 mg kg - 1 ) before induction with additional propofol (0.5 mg kg - 1 ) before laryngoscopy. The primary endpoint was hemodynamic including systolic (S) BP, diastolic (D) BP, mean arterial blood pressure (MAP) and HR measured before and after induction and ≤ 10 min after intubation. Secondary outcome was complications/adverse effects.
RESULTS


After induction, the mean SBP, DBP, MAP and HR decreased significantly from baseline in both groups except for mean HR in group LP at 1 min. Differences in mean values of SBP, DBP, and MAP were significantly lower in group D after intubation at 4-10 min (P <  0.05). Group LP had a non-inferior effect in blunting BP at all time points except 1 and 2 min after induction, and 2 min after intubation. The mean difference in HR in group D was significantly lower than that in group LP at all time points (P <  0.001). Group D had significantly more episodes of bradycardia (18.87% vs. 0%, P = 0.001) and hypotension (52.83% vs. 15.09%, P < 0.001) than did group LP.
CONCLUSION


Lidocaine (1.5 mg kg - 1 ) with additional propofol (0.5 mg kg - 1 ) had a non-inferior effect compared with dexmedetomidine (1 μg kg - 1 ) in attenuating the hemodynamic response following laryngoscopy and endotracheal intubation, and had fewer adverse effects.
TRIAL REGISTRATION


Thai Clinical Trial Registry, ( TRTC20190206002 ). Retrospectively registered 4 February 2019.",2021,"Group LP had a non-inferior effect in blunting BP at all time points except 1 and 2 min after induction, and 2 min after intubation.","['One-hundred and six patients undergoing elective general anesthesia with endotracheal intubation', 'tracheal intubation']","['propofol', 'dexmedetomidine', 'Lidocaine', 'lidocaine', 'lidocaine with propofol']","['mean values of SBP, DBP, and MAP', 'hypotension', 'blood pressure (BP), heart rate (HR), and serum catecholamine level', 'mean SBP, DBP, MAP and HR', 'blunting BP', 'episodes of bradycardia', 'hemodynamic response', 'complications/adverse effects', 'hemodynamic including systolic (S) BP, diastolic (D) BP, mean arterial blood pressure (MAP) and HR measured before and after induction and\u2009≤\u200910\u2009min after intubation']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0857910', 'cui_str': 'Serum catecholamines'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",106.0,0.0876988,"Group LP had a non-inferior effect in blunting BP at all time points except 1 and 2 min after induction, and 2 min after intubation.","[{'ForeName': 'Rattaphol', 'Initials': 'R', 'LastName': 'Seangrung', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Ratchatewi, Bangkok, 10400, Thailand. rattaphol_nu@hotmail.com.'}, {'ForeName': 'Koravee', 'Initials': 'K', 'LastName': 'Pasutharnchat', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Ratchatewi, Bangkok, 10400, Thailand.'}, {'ForeName': 'Subundit', 'Initials': 'S', 'LastName': 'Injampa', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Ratchatewi, Bangkok, 10400, Thailand.'}, {'ForeName': 'Sirima', 'Initials': 'S', 'LastName': 'Kumdang', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Ratchatewi, Bangkok, 10400, Thailand.'}, {'ForeName': 'Rojnarin', 'Initials': 'R', 'LastName': 'Komonhirun', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Ratchatewi, Bangkok, 10400, Thailand.'}]",BMC anesthesiology,['10.1186/s12871-021-01484-6']
1187,34735596,Two-surgeon simultaneous bilateral total knee arthroplasty does not provide poor prosthetic alignment : A prospective randomized controlled study.,"PURPOSE


Two-surgeon, simultaneous bilateral total knee arthroplasty (TKA) is considered as an unpredictable, complex procedure in terms of its radiographic and functional outcomes because of different surgeons and teams, and too many instruments and hands in a narrow space. We compared radiological and functional results of simultaneous bilateral TKA and single-surgeon sequential bilateral TKA.
METHODS


The 136 participants with a minimum of 24 months follow-up were prospectively randomized into 2 groups: two-surgeon bilateral TKA and single-surgeon bilateral TKA. We prespecified primary outcome of the study as between-group differences in terms of component alignment in the coronal and sagittal planes. Short-term functional outcomes were evaluated prospectively using the Oxford Knee Score (OKS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
RESULTS


Each group consisted of 136 knees of 68 patients. The mean tibial medial angles (TMA) were 89° ± 3 ° and 88° ± 5° in two-surgeons and single surgeon groups, respectively (p = 0.24). Radiological outcomes showed that the mean femoral lateral angles (FLA) were 87.9 ± 3.5° and 85.84 ± 3.7° (p = 0.12), posterior tibial slope angles (PTSA) were 8.2 ± 16.9° and 7.6 ± 17.8° (p = 0.84), and femoral flexion angles (FFA)were 86.8 ± 3.8° and 86.3 ± 3.5° (p = 0.41), anterior femoral offset ratios (AFOR) (%) were 29.5 ± 11.1 and 27.7 ± 7.9 (p = 0.31), and posterior femoral offset ratio (PFOR) (%) were 108.41 ± 31.3 and 108.45 ± 25.7 (p = 0.98), respectively.
CONCLUSION


Two-team simultaneous bilateral TKA is as safe as single stage one-surgeon sequential bilateral TKA in terms of short-term component radiological and the functional outcomes.",2022,The mean tibial medial angles (TMA) were 89° ± 3 ° and 88° ± 5,"['136 participants with a\xa0minimum of 24\xa0months follow-up', '136 knees of 68\xa0patients']","['surgeon bilateral TKA and single-surgeon bilateral TKA', 'Two-surgeon simultaneous bilateral total knee arthroplasty', 'simultaneous bilateral total knee arthroplasty (TKA']","['posterior tibial slope angles (PTSA', 'mean tibial medial angles (TMA', 'component alignment in the coronal and sagittal planes', 'anterior femoral offset ratios (AFOR', 'posterior femoral offset ratio (PFOR', 'Oxford Knee Score (OKS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC', 'femoral flexion angles', 'mean femoral lateral angles (FLA']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}]",136.0,0.17132,The mean tibial medial angles (TMA) were 89° ± 3 ° and 88° ± 5,"[{'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Yıldız', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., 34093, Fatih/Istanbul, Turkey. yildizfatih@hotmail.com.'}, {'ForeName': 'Orkhan', 'Initials': 'O', 'LastName': 'Aliyev', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., 34093, Fatih/Istanbul, Turkey.'}, {'ForeName': 'Aghamazahir', 'Initials': 'A', 'LastName': 'Aghazada', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., 34093, Fatih/Istanbul, Turkey.'}, {'ForeName': 'Nurzat', 'Initials': 'N', 'LastName': 'Elmalı', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., 34093, Fatih/Istanbul, Turkey.'}, {'ForeName': 'Gökçer', 'Initials': 'G', 'LastName': 'Uzer', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., 34093, Fatih/Istanbul, Turkey.'}, {'ForeName': 'İbrahim', 'Initials': 'İ', 'LastName': 'Tuncay', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bezmialem Vakıf University, İskender Paşa Mh Adnan Menderes Bulvarı, Adnan Menderes Blv., 34093, Fatih/Istanbul, Turkey.'}]",Der Orthopade,['10.1007/s00132-021-04183-9']
1188,34740110,Impact of combined consumption of fish oil and probiotics on the serum metabolome in pregnant women with overweight or obesity.,"BACKGROUND


If a pregnant woman is overweight, this can evoke metabolic alterations that may have health consequences for both mother and child.
METHODS


Pregnant women with overweight/obesity (n = 358) received fish oil+placebo, probiotics+placebo, fish oil+probiotics or placebo+placebo from early pregnancy onwards. The serum metabolome was analysed from fasting samples with a targeted NMR-approach in early and late pregnancy. GDM was diagnosed by OGTT.
FINDINGS


The intervention changed the metabolic profile of the women, but the effect was influenced by their GDM status. In women without GDM, the changes in nine lipids (FDR<0.05) in the fish oil+placebo-group differed when compared to the placebo+placebo-group. The combination of fish oil and probiotics induced changes in more metabolites, 46 of the lipid metabolites differed in women without GDM when compared to placebo+placebo-group; these included reduced increases in the concentrations and lipid constituents of VLDL-particles and less pronounced alterations in the ratios of various lipids in several lipoproteins. In women with GDM, no differences were detected in the changes of any metabolites due to any of the interventions when compared to the placebo+placebo-group (FDR<0.05).
INTERPRETATION


Fish oil and particularly the combination of fish oil and probiotics modified serum lipids in pregnant women with overweight or obesity, while no such effects were seen with probiotics alone. The effects were most evident in the lipid contents of VLDL and LDL only in women without GDM.
FUNDING


State Research Funding for university-level health research in the Turku University Hospital Expert Responsibility Area, Academy of Finland, the Diabetes Research Foundation, the Juho Vainio Foundation, Janssen Research & Development, LLC.",2021,"In women with GDM, no differences were detected in the changes of any metabolites due to any of the interventions when compared to the placebo+placebo-group (FDR<0.05).
","['Pregnant women with overweight/obesity (n\xa0=\xa0358) received', 'pregnant women with overweight or obesity', 'from early pregnancy onwards', 'pregnant woman is overweight']","['fish oil+placebo, probiotics+placebo, fish oil+probiotics or placebo+placebo', 'combined consumption of fish oil and probiotics', 'fish oil and probiotics modified serum lipids']","['concentrations and lipid constituents of VLDL-particles', 'lipid contents of VLDL and LDL', 'lipid metabolites', 'serum metabolome']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}]",,0.268043,"In women with GDM, no differences were detected in the changes of any metabolites due to any of the interventions when compared to the placebo+placebo-group (FDR<0.05).
","[{'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Mokkala', 'Affiliation': 'Institute of Biomedicine, Integrative Physiology and Pharmacology, 20014 University of Turku, Turku, Finland. Electronic address: kirsi.laitinen@utu.fi.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Vahlberg', 'Affiliation': 'Institute of Clinical Medicine, Biostatistics, 20014 University of Turku, Turku, Finland.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Houttu', 'Affiliation': 'Institute of Biomedicine, Integrative Physiology and Pharmacology, 20014 University of Turku, Turku, Finland.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Koivuniemi', 'Affiliation': 'Institute of Biomedicine, Integrative Physiology and Pharmacology, 20014 University of Turku, Turku, Finland.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Lahti', 'Affiliation': 'Department of Computing, 20014 University of Turku, Turku, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Laitinen', 'Affiliation': 'Institute of Biomedicine, Integrative Physiology and Pharmacology, 20014 University of Turku, Turku, Finland; Department of Obstetrics and Gynecology, Turku University Hospital, Kiinamyllynkatu 4-8, 20520 Turku, Finland. Electronic address: kirsi.laitinen@utu.fi.'}]",EBioMedicine,['10.1016/j.ebiom.2021.103655']
1189,34740705,EDP-305 in patients with NASH: A phase II double-blind placebo-controlled dose-ranging study.,"BACKGROUND & AIMS


EDP-305 is an oral farnesoid X receptor (FXR) agonist under development for the treatment of non-alcoholic steatohepatitis (NASH). Herein, we aimed to assess the efficacy, safety and tolerability of EDP-305 in patients with fibrotic NASH.
METHODS


In this double-blind phase II study, patients with fibrotic NASH (without cirrhosis), diagnosed by historical biopsy or phenotypically, were randomized to EDP-305 1 mg, EDP-305 2.5 mg, or placebo, for 12 weeks. The primary endpoint was mean change in alanine aminotransferase (ALT) from baseline to Week 12, and the key secondary endpoint was mean change in liver fat content from baseline to Week 12.
RESULTS


Between January 2018 and July 2019, 134 patients were randomized and 132 were evaluated. At Week 12, the least squares mean reductions from baseline in ALT for patients receiving 2.5 mg EDP-305 and 1 mg EDP-305 were -27.9 U/L (95% CI 0.03 to 24.9; p = 0.049) and -21.7 U/L (-5.8 to 18.3: p = 0.304), respectively, compared to -15.4 U/L for those receiving placebo. Absolute liver fat reduction was -7.1% (2.0-7.5; p = 0.0009) with 2.5 mg EDP-305, -3.3% with EDP-305 1 mg, and -2.4% with placebo. The most common (≥5%) adverse events were pruritus, nausea, vomiting, diarrhea, headache, and dizziness. Pruritus occurred in 50.9%, 9.1%, and 4.2% of patients in the 2.5 mg, 1 mg, and placebo groups, respectively, and led to study drug discontinuation in 20.8% of patients in the 2.5 mg group and 1.8% in the 1 mg group.
CONCLUSIONS


EDP-305 reduced ALT levels and liver fat content, providing support for a longer-term trial assessing histological endpoints in patients with NASH. CLINICALTRIALS.
GOV NUMBER


NCT03421431 LAY SUMMARY: Non-alcoholic fatty liver disease is a chronic hepatic disease that can progress to non-alcoholic steatohepatitis (NASH), which is associated with an increased risk of cirrhosis and liver cancer. Results from this phase II study support continued development of EDP-305, an oral farnesoid X receptor agonist, for the treatment of patients with NASH.",2022,"EDP-305 reduced ALT levels and MRI-PDFF supporting development of EDP-305 in patients with NASH in a longer-term trial assessing liver histology.
","['Between January 2018 and July 2019, 134 patients were randomized and 132 were evaluated', 'Non-cirrhotic patients with fibrotic NASH diagnosed by historical biopsy or phenotypically (high body mass index, diagnosis of diabetes (type 2 diabetes/prediabetes), and elevated alanine aminotransferase (ALT) with liver fat content >8% by magnetic resonance imaging-proton density fat fraction (MRI-PDFF', 'patients with NASH']","['placebo', 'EDP-305 1 mg, EDP-305 2.5 mg, or placebo', 'EDP-305']","['ALT levels and MRI-PDFF supporting development of EDP-305', 'Pruritus', 'mean change from baseline to Week 12 for ALT', 'efficacy, safety, and tolerability', 'pruritus, nausea, vomiting, diarrhea, headache, and dizziness', 'Absolute liver fat reduction']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C4761214', 'cui_str': 'Magnetic resonance proton density fat fraction measurement'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4761214', 'cui_str': 'Magnetic resonance proton density fat fraction measurement'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",134.0,0.431802,"EDP-305 reduced ALT levels and MRI-PDFF supporting development of EDP-305 in patients with NASH in a longer-term trial assessing liver histology.
","[{'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Ratziu', 'Affiliation': 'Sorbonne Université, ICAN, Hospital Pitié-Salpêtrière, INSERM UMRS 1138 CRC, Paris, France.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Rinella', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Neuschwander-Tetri', 'Affiliation': 'Saint Louis University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lawitz', 'Affiliation': 'Texas Liver Institute, San Antonio, TX United States.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Denham', 'Affiliation': 'Clinical Trials of Texas, Inc., San Antonio, TX, United States.'}, {'ForeName': 'Zeid', 'Initials': 'Z', 'LastName': 'Kayali', 'Affiliation': 'Inland Empire Liver Foundation, Rialto, CA, United States.'}, {'ForeName': 'Aasim', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'GI Specialists of Georgia, Marietta, GA United States.'}, {'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Liver Institute Northwest and Elson S. Floyd College of Medicine, Washington State University, Seattle, WA, United States.'}, {'ForeName': 'Taddese', 'Initials': 'T', 'LastName': 'Desta', 'Affiliation': 'Precision Research Institute, San Diego, CA, United States.'}, {'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'Elkhashab', 'Affiliation': 'Toronto Liver Center, Toronto, Ontario, Canada.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'DeGrauw', 'Affiliation': 'Synexus - Wasatch Peak Family Practice, Layton, UT, United States.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Goodwin', 'Affiliation': 'Enanta Pharmaceuticals, Inc, Watertown, MA, United States.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Ahmad', 'Affiliation': 'Enanta Pharmaceuticals, Inc, Watertown, MA, United States.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Adda', 'Affiliation': 'Enanta Pharmaceuticals, Inc, Watertown, MA, United States. Electronic address: nadda@enanta.com.'}]",Journal of hepatology,['10.1016/j.jhep.2021.10.018']
1190,34740861,Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC.,"INTRODUCTION


Adjuvant chemotherapy is recommended in patients with resected stages II to IIIA (and select IB) NSCLC; however, recurrence rates are high. In the phase 3 ADAURA study (NCT02511106), osimertinib was found to have a clinically meaningful improvement in disease-free survival (DFS) in patients with resected stages IB to IIIA EGFR-mutated (EGFRm) NSCLC. Here, we report prespecified and exploratory analyses of adjuvant chemotherapy use and outcomes from ADAURA.
METHODS


Patients with resected stages IB to IIIA EGFRm NSCLC were randomized 1:1 to receive osimertinib or placebo for 3 years. Adjuvant chemotherapy before randomization was not mandatory, per physician and patient choice. DFS in the overall population (IB-IIIA), with and without adjuvant chemotherapy, was a prespecified analysis. Exploratory analyses included the following: adjuvant chemotherapy use by patient age, disease stage, and geographic location; DFS by adjuvant chemotherapy use and disease stage.
RESULTS


Overall, 410 of 682 patients (60%) received adjuvant chemotherapy (osimertinib, n = 203; placebo, n = 207) for a median duration of 4.0 cycles. Adjuvant chemotherapy use was more frequent in patients: aged less than 70 years (338 of 509; 66%) versus more than or equal to 70 years (72 of 173; 42%); with stages II to IIIA (352 of 466; 76%) versus stage IB (57 of 216; 26%); and enrolled in Asia (268 of 414; 65%) versus outside of Asia (142 of 268; 53%). A DFS benefit favoring osimertinib versus placebo was observed in patients with (DFS hazard ratio = 0.16, 95% confidence interval: 0.10-0.26) and without adjuvant chemotherapy (hazard ratio = 0.23, 95% confidence interval: 0.13-0.40), regardless of disease stage.
CONCLUSIONS


These findings support adjuvant osimertinib as an effective treatment for patients with stages IB to IIIA EGFRm NSCLC after resection, with or without previous adjuvant chemotherapy.",2022,Adjuvant chemotherapy use was more frequent in patients: aged <70 years (338/509; 66%) versus ≥70 years (72/173; 42%); with stage II-IIIA disease (352/466; 76%) versus stage IB (57/216; 26%); enrolled in Asia (268/414; 65%) versus outside of Asia (142/268; 53%).,"['patients with resected stage IIꟷIIIA (and select IB) NSCLC', 'use by patient age, disease stage and geographical location; DFS by adjuvant chemotherapy use and disease stage', 'Patients with resected stage IBꟷIIIA', 'patients: aged <70 years (338/509; 66%) versus ≥70 years (72/173; 42%); with stage II-IIIA disease (352/466; 76%) versus stage IB (57/216; 26%); enrolled in Asia (268/414; 65%) versus outside of Asia (142/268; 53', 'patients with stage', 'patients with resected stage IBꟷIIIA EGFRm NSCLC']","['Adjuvant chemotherapy', 'osimertinib or placebo', 'IB-IIIA EGFRm NSCLC after resection, with or without prior adjuvant chemotherapy', 'EGFRm NSCLC', 'Postoperative Chemotherapy Use and Outcomes From ADAURA', 'placebo', 'adjuvant chemotherapy']",['disease-free survival (DFS'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4545686', 'cui_str': 'Geographical location (property)'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0205101', 'cui_str': 'External'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",207.0,0.477429,Adjuvant chemotherapy use was more frequent in patients: aged <70 years (338/509; 66%) versus ≥70 years (72/173; 42%); with stage II-IIIA disease (352/466; 76%) versus stage IB (57/216; 26%); enrolled in Asia (268/414; 65%) versus outside of Asia (142/268; 53%).,"[{'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China. Electronic address: syylwu@live.cn.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'John', 'Affiliation': 'Department of Medical Oncology, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grohe', 'Affiliation': 'Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin, Germany.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Goldman', 'Affiliation': 'David Geffen School of Medicine at University of California, Los Angeles, California.'}, {'ForeName': 'Sang-We', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Laktionov', 'Affiliation': 'Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO), Moscow, Russia.'}, {'ForeName': 'Huu Vinh', 'Initials': 'HV', 'LastName': 'Vu', 'Affiliation': 'Department of Thoracic Surgery, Choray Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Molecular Oncology, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': ""Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.""}, {'ForeName': 'Kye Young', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': 'Precision Medicine Lung Cancer Center, Konkuk University Medical Center, Seoul, South Korea.'}, {'ForeName': 'Charuwan', 'Initials': 'C', 'LastName': 'Akewanlop', 'Affiliation': 'Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Chong-Jen', 'Initials': 'CJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital Hsinchu Branch and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Marinis', 'Affiliation': 'Thoracic Oncology Division, European Institute of Oncology (IEO), IRCCS, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bonanno', 'Affiliation': 'Medical Oncology 2, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Domine', 'Affiliation': 'Oncology Department, Instituto de Investigación Sanitaria-Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Frances A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': 'Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Lingmin', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'Late Oncology Statistics, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Ajlan', 'Initials': 'A', 'LastName': 'Atasoy', 'Affiliation': 'Late Oncology Research & Development, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Roy S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': 'Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, Connecticut.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2021.10.014']
1191,34741172,Positive effects of amphiregulin on human oocyte maturation and its molecular drivers in patients with polycystic ovary syndrome.,"STUDY QUESTION


Does use of medium containing amphiregulin improve meiotic maturation efficiency in oocytes of women with polycystic ovary syndrome (PCOS) undergoing in vitro maturation (IVM) preceded by a capacitation culture step capacitation IVM (CAPA-IVM)?
SUMMARY ANSWER


Use of medium containing amphiregulin significantly increased the maturation rate from oocytes retrieved from follicles with diameters <6 or ≥6 mm pre-cultured in capacitation medium.
WHAT IS KNOWN ALREADY


Amphiregulin concentration in follicular fluid is correlated with human oocyte developmental competence. Amphiregulin added to the meiotic trigger has been shown to improve outcomes of IVM in a range of mammalian species.
STUDY DESIGN, SIZE, DURATION


This prospective, randomized cohort study included 30 patients and was conducted at an academic infertility centre in Vietnam from April to December 2019. Patients with PCOS were included.
PARTICIPANTS/MATERIALS, SETTING, METHODS


In the first stage, sibling oocytes from each patient (671 in total) were allocated in equal numbers to maturation in medium with (CAPA-AREG) or without (CAPA-Control) amphiregulin 100 ng/ml. After a maturation check and fertilization using intracytoplasmic sperm injection (ICSI), all good quality Day 3 embryos were vitrified. Cumulus cells (CCs) from both groups were collected at the moment of ICSI denudation and underwent a molecular analysis to quantify key transcripts of oocyte maturation and to relate these to early embryo development. On return for frozen embryo transfer (second stage), patients were randomized to have either CAPA-AREG or CAPA-Control embryo(s) implanted. Where no embryo(s) from the randomized group were available, embryo(s) from the other group were transferred. The primary endpoint of the study was meiotic maturation efficiency (proportion of metaphase II [MII] oocytes; maturation rate).
MAIN RESULTS AND THE ROLE OF CHANCE


In the per-patient analysis, the number of MII oocytes was significantly higher in the CAPA-AREG group versus the CAPA-Control group (median [interquartile range] 7.0 [5.3, 8.0] versus 6.0 [4.0, 7.0]; P = 0.01). When each oocyte was evaluated, the maturation rate was also significantly higher in the CAPA-AREG group versus the CAPA-Control group (67.6% versus 55.2%; relative risk [RR] 1.22 [95% confidence interval (CI) 1.08-1.38]; P = 0.001). No other IVM or embryology outcomes differed significantly between the two groups. Rates of clinical pregnancy (66.7% versus 42.9%; RR 1.56 [95% CI 0.77-3.14]), ongoing pregnancy (53.3% versus 28.6%; RR 1.87 [95% CI 0.72-4.85]) and live birth (46.7% versus 28.6%; RR 1.63 [95% CI 0.61-4.39]) were numerically higher in the patients who had CAPA-AREG versus CAPA-Control embryos implanted, but each fertility and obstetric outcome did not differ significantly between the groups. In the CAPA-AREG group, there were significant shifts in CC expression of genes involved in steroidogenesis (STAR, 3BHSD), the ovulatory cascade (DUSP16, EGFR, HAS2, PTGR2, PTGS2, RPS6KA2), redox and glucose metabolism (CAT, GPX1, SOD2, SLC2A1, LDHA) and transcription (NRF2). The expression of three genes (TRPM7, VCAN and JUN) in CCs showed a significant correlation with embryo quality.
LIMITATIONS, REASONS FOR CAUTION


This study included only Vietnamese women with PCOS, limiting the generalizability. Although 100 ng/ml amphiregulin addition to the maturation culture step significantly improved the MII rate, the sample size in this study was small, meaning that these findings should be considered as exploratory. Therefore, a larger patient cohort is needed to confirm whether the positive effects of amphiregulin translate into improved fertility outcomes in patients undergoing IVM.
WIDER IMPLICATIONS OF THE FINDINGS


Data from this study confirm the beneficial effects of amphiregulin during IVM with respect to the trigger of oocyte maturation. The gene expression findings in cumulus indicate that multiple pathways might contribute to these beneficial effects and confirm the key role of the epidermal growth factor system in the stepwise acquisition of human oocyte competence.
STUDY FUNDING/COMPETING INTEREST(S)


This work was funded by the Vietnam National Foundation for Science and Technology Development (NAFOSTED; grant number FWO.106-YS.2017.02) and by the Fund for Research Flanders (FWO; grant number G.OD97.18N). L.N.V. has received speaker and conference fees from Merck, grants, speaker and conference fees from Merck Sharpe and Dohme, and speaker, conference and scientific board fees from Ferring. T.M.H. has received speaker fees from Merck, Merck Sharp and Dohme and Ferring. J.S. reports speaker fees from Ferring Pharmaceuticals and Biomérieux Diagnostics and grants from FWO Flanders, is co-inventor on granted patents on CAPA-IVM methodologies in USA (US10392601B2), Europe (EP3234112B1) and Japan (JP 6806683 registered 08-12-2020) and is a co-shareholder of Lavima Fertility Inc., a spin-off company of the Vrije Universiteit Brussel (VUB, Brussels, Belgium). NA, TDP, AHL, MNHN, SR, FS, EA and UDTH report no financial relationships with any organizations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work.
TRIAL REGISTRATION NUMBER


NCT03915054.",2021,"containing amphiregulin significantly increased the maturation rate from oocytes retrieved from follicles with diameters <6 or ≥6 mm pre-cultured in capacitation medium.
","['women with polycystic ovary syndrome (PCOS) undergoing in vitro maturation (IVM', 'Vietnamese women with PCOS, limiting the generalizability', '30 patients and was conducted at an academic infertility centre in Vietnam from April to December 2019', 'patients with polycystic ovary syndrome', 'patients undergoing IVM', 'Patients with PCOS were included']","['intracytoplasmic sperm injection (ICSI', 'medium with (CAPA-AREG) or without (CAPA-Control) amphiregulin 100 ng/ml', 'amphiregulin', 'CAPA-AREG', 'medium containing amphiregulin']","['Rates of clinical pregnancy', 'fertility and obstetric outcome', 'meiotic maturation efficiency', 'number of MII oocytes', 'live birth', 'CC expression of genes involved in steroidogenesis (STAR, 3BHSD), the ovulatory cascade (DUSP16, EGFR, HAS2, PTGR2, PTGS2, RPS6KA2), redox and glucose metabolism (CAT, GPX1, SOD2, SLC2A1, LDHA) and transcription (NRF2', 'MII rate', 'fertility outcomes', 'maturation rate', 'IVM or embryology outcomes', 'Cumulus cells (CCs', 'ongoing pregnancy', 'meiotic maturation efficiency (proportion of metaphase II [MII] oocytes; maturation rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1720416', 'cui_str': 'Episodic ataxia type 2'}, {'cui': 'C3884535', 'cui_str': 'AREG protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0051755', 'cui_str': 'Schwannoma-derived Growth Factor'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C4317103', 'cui_str': 'HAS2 Protein'}, {'cui': 'C0387583', 'cui_str': 'Cyclooxygenase 2'}, {'cui': 'C2002840', 'cui_str': 'RPS6KA2 protein, human'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C1504631', 'cui_str': 'SLC2A1 protein, human'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C1565078', 'cui_str': 'NFE2L2 protein, human'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0013942', 'cui_str': 'Embryology'}, {'cui': 'C1956101', 'cui_str': 'Granulosa Cells, Cumulus'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}]",30.0,0.136531,"containing amphiregulin significantly increased the maturation rate from oocytes retrieved from follicles with diameters <6 or ≥6 mm pre-cultured in capacitation medium.
","[{'ForeName': 'Nazli', 'Initials': 'N', 'LastName': 'Akin', 'Affiliation': 'Follicle Biology Laboratory, UZ Brussel, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Anh H', 'Initials': 'AH', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Uyen D T', 'Initials': 'UDT', 'LastName': 'Ha', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Romero', 'Affiliation': 'Laboratory of Reproductive Biology and Fertility Preservation, Cayetano Heredia University (UPCH), Lima, Peru.'}, {'ForeName': 'Flor', 'Initials': 'F', 'LastName': 'Sanchez', 'Affiliation': 'Laboratory of Reproductive Biology and Fertility Preservation, Cayetano Heredia University (UPCH), Lima, Peru.'}, {'ForeName': 'Toan D', 'Initials': 'TD', 'LastName': 'Pham', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Minh H N', 'Initials': 'MHN', 'LastName': 'Nguyen', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Anckaert', 'Affiliation': 'Follicle Biology Laboratory, UZ Brussel, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Tuong M', 'Initials': 'TM', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Smitz', 'Affiliation': 'Follicle Biology Laboratory, UZ Brussel, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'Lan N', 'Initials': 'LN', 'LastName': 'Vuong', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deab237']
1192,32376678,The Effects of Intensive Blood Pressure Lowering on Markers of Mineral Metabolism in Persons with CKD in SPRINT.,,2020,,['Persons with CKD in SPRINT'],['Intensive Blood Pressure Lowering'],['Markers of Mineral Metabolism'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.049082,,"[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ginsberg', 'Affiliation': 'Nephrology Section, Veterans Affairs San Diego Healthcare System, San Diego, California cginsberg@ucsd.edu.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle, Washington.'}, {'ForeName': 'Michel B', 'Initials': 'MB', 'LastName': 'Chonchol', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Anschutz Medical Center, Aurora, Colorado.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Bullen', 'Affiliation': 'Nephrology Section, Veterans Affairs San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Zhang', 'Affiliation': 'Kidney Health Research Collaborative, Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Bates', 'Affiliation': 'Department of Medicine, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Neyra', 'Affiliation': 'Division of Nephrology, Bone and Mineral Metabolism, Department of Internal Medicine, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Killeen', 'Affiliation': 'Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'Punzi Medical Center, Carrollton, Texas.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Kidney Health Research Collaborative, Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Nephrology Section, Veterans Affairs San Diego Healthcare System, San Diego, California.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.01400220']
1193,34661903,Provision of folic acid for reducing arsenic toxicity in arsenic-exposed children and adults.,"BACKGROUND


Arsenic is a common environmental toxin. Exposure to arsenic (particularly its inorganic form) through contaminated food and drinking water is an important public health burden worldwide, and is associated with increased risk of neurotoxicity, congenital anomalies, cancer, and adverse neurodevelopment in children. Arsenic is excreted following methylation reactions, which are mediated by folate. Provision of folate through folic acid supplements could facilitate arsenic methylation and excretion, thereby reducing arsenic toxicity.
OBJECTIVES


To assess the effects of provision of folic acid (through fortified foods or supplements), alone or in combination with other nutrients, in lessening the burden of arsenic-related health outcomes and reducing arsenic toxicity in arsenic-exposed populations.
SEARCH METHODS


In September 2020, we searched CENTRAL, MEDLINE, Embase, 10 other international databases, nine regional databases, and two trials registers.
SELECTION CRITERIA


Randomised controlled trials (RCTs) and quasi-RCTs comparing the provision of folic acid (at any dose or duration), alone or in combination with other nutrients or nutrient supplements, with no intervention, placebo, unfortified food, or the same nutrient or supplements without folic acid, in arsenic-exposed populations of all ages and genders.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane.
MAIN RESULTS


We included two RCTs with 822 adults exposed to arsenic-contaminated drinking water in Bangladesh. The RCTs compared 400 µg/d (FA400) or 800 µg/d (FA800) folic acid supplements, given for 12 or 24 weeks, with placebo. One RCT, a multi-armed trial, compared FA400 plus creatine (3 g/d) to creatine alone. We judged both RCTs at low risk of bias in all domains. Due to differences in co-intervention, arsenic exposure, and participants' nutritional status, we could not conduct meta-analyses, and therefore, provide a narrative description of the data. Neither RCT reported on cancer, all-cause mortality, neurocognitive function, or congenital anomalies. Folic acid supplements alone versus placebo Blood arsenic. In arsenic-exposed individuals, FA likely reduces blood arsenic concentrations compared to placebo (2 studies, 536 participants; moderate-certainty evidence). For folate-deficient and folate-replete participants who received arsenic-removal water filters as a co-intervention, FA800 reduced blood arsenic levels more than placebo (percentage change (%change) in geometric mean (GM) FA800 -17.8%, 95% confidence intervals (CI) -25.0 to -9.8; placebo GM -9.5%, 95% CI -16.5 to -1.8; 1 study, 406 participants). In one study with 130 participants with low baseline plasma folate, FA400 reduced total blood arsenic (%change FA400 mean (M) -13.62%, standard error (SE) ± 2.87; placebo M -2.49%, SE ± 3.25), and monomethylarsonic acid (MMA) concentrations (%change FA400 M -22.24%, SE ± 2.86; placebo M -1.24%, SE ± 3.59) more than placebo. Inorganic arsenic (InAs) concentrations reduced in both groups (%change FA400 M -18.54%, SE ± 3.60; placebo M -10.61%, SE ± 3.38). There was little to no change in dimethylarsinic acid (DMA) in either group. Urinary arsenic. In arsenic-exposed individuals, FA likely reduces the proportion of total urinary arsenic excreted as InAs (%InAs) and MMA (%MMA) and increases the proportion excreted as DMA (%DMA) to a greater extent than placebo (2 studies, 546 participants; moderate-certainty evidence), suggesting that FA enhances arsenic methylation. In a mixed folate-deficient and folate-replete population (1 study, 352 participants) receiving arsenic-removal water filters as a co-intervention, groups receiving FA had a greater decrease in %InAs (within-person change FA400 M -0.09%, 95% CI -0.17 to -0.01; FA800 M -0.14%, 95% CI -0.21 to -0.06; placebo M 0.05%, 95% CI 0.00 to 0.10), a greater decrease in %MMA (within-person change FA400 M -1.80%, 95% CI -2.53 to -1.07; FA800 M -2.60%, 95% CI -3.35 to -1.85; placebo M 0.15%, 95% CI -0.37 to 0.68), and a greater increase in %DMA (within-person change FA400 M 3.25%, 95% CI 1.81 to 4.68; FA800 M 4.57%, 95% CI 3.20 to 5.95; placebo M -1.17%, 95% CI -2.18 to -0.17), compared to placebo. In 194 participants with low baseline plasma folate, FA reduced %InAs (%change FA400 M -0.31%, SE ± 0.04; placebo M -0.13%, SE ± 0.04) and %MMA (%change FA400 M -2.6%, SE ± 0.37; placebo M -0.71%, SE ± 0.43), and increased %DMA (%change FA400 M 5.9%, SE ± 0.82; placebo M 2.14%, SE ± 0.71), more than placebo. Plasma homocysteine: In arsenic-exposed individuals, FA400 likely reduces homocysteine concentrations to a greater extent than placebo (2 studies, 448 participants; moderate-certainty evidence), in the mixed folate-deficient and folate-replete population receiving arsenic-removal water filters as a co-intervention (%change in GM FA400 -23.4%, 95% CI -27.1 to -19.5; placebo -1.3%, 95% CI -5.3 to 3.1; 1 study, 254 participants), and participants with low baseline plasma folate (within-person change FA400 M -3.06 µmol/L, SE ± 3.51; placebo M -0.05 µmol/L, SE ± 4.31; 1 study, 194 participants). FA supplements plus other nutrient supplements versus nutrient supplements alone In arsenic-exposed individuals who received arsenic-removal water filters as a co-intervention, FA400 plus creatine may reduce blood arsenic concentrations more than creatine alone (%change in GM FA400 + creatine -14%, 95% CI -22.2 to -5.0; creatine -7.0%, 95% CI -14.8 to 1.5; 1 study, 204 participants; low-certainty evidence); may not change urinary arsenic methylation indices (FA400 + creatine: %InAs M 13.2%, SE ± 7.0; %MMA M 10.8, SE ± 4.1; %DMA M 76, SE ± 7.8; creatine: %InAs M 14.8, SE ± 5.5; %MMA M 12.8, SE ± 4.0; %DMA M 72.4, SE ±7.6; 1 study, 190 participants; low-certainty evidence); and may reduce homocysteine concentrations to a greater extent (%change in GM FA400 + creatinine -21%, 95% CI -25.2 to -16.4; creatine -4.3%, 95% CI -9.0 to 0.7; 1 study, 204 participants; low-certainty evidence) than creatine alone.
AUTHORS' CONCLUSIONS


There is moderate-certainty evidence that FA supplements may benefit blood arsenic concentration, urinary arsenic methylation profiles, and plasma homocysteine concentration versus placebo. There is low-certainty evidence that FA supplements plus other nutrients may benefit blood arsenic and plasma homocysteine concentrations versus nutrients alone. No studies reported on cancer, all-cause mortality, neurocognitive function, or congenital anomalies. Given the limited number of RCTs, more studies conducted in diverse settings are needed to assess the effects of FA on arsenic-related health outcomes and arsenic toxicity in arsenic-exposed adults and children.",2021,"FA800 M -0.14%, 95% CI -0.21 to -0.06; placebo M 0.05%, 95% CI 0.00 to 0.10), a greater decrease in %MMA (within-person change FA400 M -1.80%, 95% CI -2.53 to -1.07; FA800 M -2.60%, 95% CI -3.35 to -1.85; placebo M 0.15%, 95% CI -0.37 to 0.68), and a greater increase in %DMA (within-person change FA400 M 3.25%, 95% CI 1.81 to 4.68; FA800 M 4.57%, 95% CI 3.20 to 5.95; placebo M -1.17%, 95% CI -2.18 to -0.17), compared to placebo.","['arsenic-exposed children and adults', 'arsenic-exposed populations', '130 participants with low baseline plasma folate, FA400 reduced total blood arsenic (%change', '822 adults exposed to arsenic-contaminated drinking water in Bangladesh', 'arsenic-exposed adults and children', '352 participants) receiving', 'children']","['arsenic-removal water filters', 'folic acid supplements', 'folic acid', 'Folic acid supplements alone versus placebo Blood arsenic', 'placebo', 'folic acid (at any dose or duration), alone or in combination with other nutrients or nutrient supplements, with no intervention, placebo, unfortified food, or the same nutrient or supplements without folic acid']","['monomethylarsonic acid (MMA) concentrations', 'Inorganic arsenic (InAs) concentrations', 'arsenic toxicity', 'dimethylarsinic acid (DMA', 'DMA', 'blood arsenic and plasma homocysteine concentrations', 'Urinary arsenic', 'Plasma homocysteine', 'urinary arsenic methylation indices', 'MMA', 'cause mortality, neurocognitive function, or congenital anomalies', 'blood arsenic concentrations', 'proportion of total urinary arsenic', 'homocysteine concentrations', 'blood arsenic concentration, urinary arsenic methylation profiles, and plasma homocysteine concentration', 'blood arsenic levels']","[{'cui': 'C0003818', 'cui_str': 'Arsenic'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0003818', 'cui_str': 'Arsenic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3653937', 'cui_str': 'OTHER NUTRIENTS'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0066766', 'cui_str': 'monomethylarsonic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0936225', 'cui_str': 'Inorganic arsenic'}, {'cui': 'C0311375', 'cui_str': 'Toxic effect of arsenic and its compounds'}, {'cui': 'C0006628', 'cui_str': 'Dimethylarsinic Acid'}, {'cui': 'C0013013', 'cui_str': 'Commonwealth of Dominica'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0003818', 'cui_str': 'Arsenic'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0202325', 'cui_str': 'Arsenic measurement, blood'}]",194.0,0.478017,"FA800 M -0.14%, 95% CI -0.21 to -0.06; placebo M 0.05%, 95% CI 0.00 to 0.10), a greater decrease in %MMA (within-person change FA400 M -1.80%, 95% CI -2.53 to -1.07; FA800 M -2.60%, 95% CI -3.35 to -1.85; placebo M 0.15%, 95% CI -0.37 to 0.68), and a greater increase in %DMA (within-person change FA400 M 3.25%, 95% CI 1.81 to 4.68; FA800 M 4.57%, 95% CI 3.20 to 5.95; placebo M -1.17%, 95% CI -2.18 to -0.17), compared to placebo.","[{'ForeName': 'Sajin', 'Initials': 'S', 'LastName': 'Bae', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Kamynina', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Guetterman', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Adetutu F', 'Initials': 'AF', 'LastName': 'Farinola', 'Affiliation': 'Faculty of Public Health, Department of Human Nutrition and Dietetics, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Caudill', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Berry', 'Affiliation': 'National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cassano', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Stover', 'Affiliation': 'Texas A&M University, College Station, TX, USA.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012649.pub2']
1194,34700272,Influence of nimodipine combined with ulinastatin on neurological function and inflammatory reaction in patients with cerebral vasospasm after subarachnoid hemorrhage.,"OBJECTIVE


This study aimed to discuss the influence of nimodipine+ulinastatin on the neurological function and inflammatory reaction in patients with cerebral vasospasm (CVS) after subarachnoid hemorrhage (SAH).
METHODS


Overall, 90 patients with CVS after SAH who were admitted to our hospital were enrolled in this study and randomly divided into research and control groups (n = 45 for both groups). On the basis of conventional therapy, patients in the control group were injected with ulinastatin and those in the research group were injected with ulinastatin+nimodipine through an intravenous drip for 7 days with the others the same as those of the control group.
RESULTS


Blood flow velocity in all cerebral arteries was lower in the research group than in the control group after treatment (P < 0.05). Calcitonin gene-related peptide and nitric oxide levels were higher in the research group than in the control group after treatment (P < 0.05). Endothelin levels were lower in the research group than in the control group (P < 0.05). The total effective rate was higher in the research group than in the control group (P < 0.05). Glasgow Coma Scale scores were higher in the research group than in the control group (P < 0.05).
CONCLUSION


The drug combination of nimodipine and ulinastatin improved blood flow and neurological function in patients with CVS after SAH and enhanced the therapeutic efficacy; the underlying mechanism may be associated with the regulation of vascular endothelial dilatation function and the inhibition of relevant inflammatory factors' expression.",2021,Calcitonin gene-related peptide and nitric oxide levels were higher in the research group than in the control group after treatment (P < 0.05).,"['patients with cerebral vasospasm after subarachnoid hemorrhage', '90 patients with CVS after SAH who were admitted to our hospital', 'patients with cerebral vasospasm (CVS) after subarachnoid hemorrhage (SAH', 'patients with CVS after SAH']","['nimodipine and ulinastatin', 'nimodipine+ulinastatin', 'ulinastatin+nimodipine', 'ulinastatin', 'nimodipine combined with ulinastatin']","['total effective rate', 'Calcitonin gene-related peptide and nitric oxide levels', 'Endothelin levels', 'neurological function and inflammatory reaction', 'blood flow and neurological function', 'Blood flow velocity', 'Glasgow Coma Scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0265110', 'cui_str': 'Spasm of cerebral arteries'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C0077906', 'cui_str': 'urinastatin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079284', 'cui_str': 'Endothelin'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",90.0,0.0280608,Calcitonin gene-related peptide and nitric oxide levels were higher in the research group than in the control group after treatment (P < 0.05).,"[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Department of Neurology, the Affiliated Huai'an Hospital of Xuzhou Medical University, Huai'an, Jiangsu, China. Electronic address: chenming801123@sina.cn.""}, {'ForeName': 'Qingxiu', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, the Second Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China. Electronic address: qingxiuzhang@126.com.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, the Second Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China. Electronic address: lhy4531@yeah.net.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Zou', 'Affiliation': ""Department of Neurology, the Affiliated Huai'an Hospital of Xuzhou Medical University, Huai'an, Jiangsu, China. Electronic address: zww051710@163.com.""}, {'ForeName': 'Xiue', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Neurology, the Second Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China. Electronic address: wxeqq@163.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2021.106981']
1195,34740318,Measurement of the nociceptive flexion reflex threshold in critically ill patients - a randomized observational pilot study.,"BACKGROUND


Pain detection and treatment is a major challenge in the care of critically ill patients, rendered more complex by the need to take into consideration the risk of insufficient or excessive analgesia. The nociceptive flexion reflex threshold (NFRT) has become the established basis for measuring the level of analgesia in the perioperative context. However, it remains unclear whether NFRT measurement can be usefully applied to mechanically ventilated, analgosedated critically ill patients who are unable to communicate. Therefore, the aim of the present study was to investigate whether there is an association between the NFRT measurement and the Behavioral Pain Scale (BPS) in critically ill, analgosedated, and mechanically ventilated patients and whether the NFRT measurement can also detect potential excessive analgesia.
METHODS


This prospective, observational, randomized single-center pilot study included patients admitted to the surgical Intensive Care Unit of University Hospital Ulm, Germany, all of whom were analgosedated and intubated. Major exclusion criteria were defined as the need for the administration of neuromuscular blocking agents or neurological diseases associated with peripheral nerve conduction restriction. Initial NFRT and BPS measurements were conducted within 12 h after admission. A structured pain assessment was performed at least twice daily until extubation throughout the observation period thereafter (Group A: BPS + NFRT, Group B: BPS).
RESULTS


114 patients were included in the study. NFRT is associated negatively with BPS. NFRT was almost twice as high in patients with a Richmond Agitation Sedation Scale (RASS) score of -5 than in patients with a RASS score ≥ -4 (RASS -5 - NFRT: 59.40 vs. RASS -4 - NFRT: 29.00, p < 0.001).
CONCLUSIONS


NFRT measurement is associated negatively with the BPS in critically ill patients. NFRT measurement provides guidance for the evaluation of nociceptive processes in patients with RASS scores ≤ -4, in whom analgesia level is often difficult to assess. However, in order to identify excessive analgesia and derive therapeutic consequences, it is necessary to gradually decrease analgesics and sedatives until a stimulus threshold is reached at which the patient does not feel pain.
TRIAL REGISTRATION


Retrospectively registered in the German Clinical Trials Register, registration number DRKS00021149, date of registration: March 26, 2020. https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00021149 .",2021,"NFRT measurement provides guidance for the evaluation of nociceptive processes in patients with RASS scores ≤ -4, in whom analgesia level is often difficult to assess.","['critically ill patients', 'patients admitted to the surgical Intensive Care Unit of University Hospital Ulm, Germany, all of whom were analgosedated and intubated', 'patients with RASS scores', '114 patients were included in the study']","['NFRT', 'nociceptive flexion reflex threshold (NFRT']","['Initial NFRT and BPS measurements', 'Richmond Agitation Sedation Scale (RASS) score', 'Behavioral Pain Scale (BPS']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",114.0,0.0454629,"NFRT measurement provides guidance for the evaluation of nociceptive processes in patients with RASS scores ≤ -4, in whom analgesia level is often difficult to assess.","[{'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Schick', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany. benedikt-1.zujalovic@uni-ulm.de.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mayer', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, Ulm University, Schwabstraße 13, 89075, Ulm, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Walter', 'Affiliation': 'Department of Medical Psychology, Ulm University, Frauensteige 6, 89075, Ulm, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Gruss', 'Affiliation': 'Department of Medical Psychology, Ulm University, Frauensteige 6, 89075, Ulm, Germany.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Stitz', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Stitz', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Barth', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}]",BMC anesthesiology,['10.1186/s12871-021-01490-8']
1196,34656873,Repetitive use of LEvosimendan in Ambulatory Heart Failure patients (LEIA-HF) - The rationale and study design.,"PURPOSE


Clinical practice forces the necessity to conduct a clinical trial concerning the group of outpatients with chronically advanced heart failure in III or IV NYHA functional class, frequently requiring hospitalizations due to HF exacerbation, and often left without any additional therapeutic option. The current trial aims to determine the efficacy and safety of repeated levosimendan infusions in the group of severe outpatients with reduced ejection fraction (HFrEF).
MATERIAL AND METHODS


LEIA-HF (LEvosimendan In Ambulatory Heart Failure Patients) is a multicentre, randomized, double-blind, placebo-controlled, phase 4 clinical trial to determine whether the repetitive use of levosimendan reduces the incidence of adverse cardiovascular events in ambulatory patients with chronic, advanced HFrEF. A total of 350 patients will be randomized in a 1:1 ratio to receive either levosimendan or placebo, which will be administered as continuous 24 ​h infusions, every 4 weeks for 48 weeks (12 infusions in total - phase I), and followed by double-blind 6 visits, every 4 weeks (phase II of the trial including the option of restarting levosimendan or placebo, based on the fulfillment of additional criteria). The primary endpoint for efficacy assessment will be death from any cause or unplanned hospitalization for HF assessed together, whichever occurs first, in a 12-month follow-up period.
CONCLUSIONS


A well-designed study with a consistent protocol, including the drug side effects, comprehensive clinical assessment, appropriate definition of endpoints, and monitoring therapy, may provide a complete overview of the effectiveness and safety profile of the repetitive levosimendan administration in ambulatory severe HFrEF patients.",2021,"The current trial aims to determine the efficacy and safety of repeated levosimendan infusions in the group of severe outpatients with reduced ejection fraction (HFrEF).
","['ambulatory severe HFrEF patients', 'outpatients with chronically advanced heart failure in III or IV NYHA functional class, frequently requiring hospitalizations due to HF exacerbation, and often left without any additional therapeutic option', 'severe outpatients with reduced ejection fraction (HFrEF', 'Ambulatory Heart Failure patients (LEIA-HF) ', '350 patients', 'Ambulatory Heart Failure Patients', 'ambulatory patients with chronic, advanced HFrEF']","['repetitive levosimendan', 'levosimendan infusions', 'levosimendan or placebo', 'levosimendan', 'HF (LEvosimendan', 'placebo', 'LEvosimendan']","['adverse cardiovascular events', 'efficacy assessment will be death from any cause or unplanned hospitalization for HF assessed together, whichever occurs first', 'efficacy and safety']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",350.0,0.520934,"The current trial aims to determine the efficacy and safety of repeated levosimendan infusions in the group of severe outpatients with reduced ejection fraction (HFrEF).
","[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Tycińska', 'Affiliation': 'Department of Cardiology, Medical University of Bialystok, Bialystok, Poland. Electronic address: agnieszka.tycinska@gmail.com.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Gierlotka', 'Affiliation': 'Department of Cardiology, Institute of Medical Sciences, University of Opole, Opole, Poland. Electronic address: marek.gierlotka@uni.opole.pl.'}, {'ForeName': 'Stanisław', 'Initials': 'S', 'LastName': 'Bartuś', 'Affiliation': 'Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Gąsior', 'Affiliation': 'Third Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University in Katowice, Silesian Center for Heart Diseases, Zabrze, Poland.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Główczyńska', 'Affiliation': 'First Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Grześk', 'Affiliation': 'Department of Cardiology and Clinical Pharmacology, Faculty of Health Sciences, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Bydgoszcz, Poland.'}, {'ForeName': 'Miłosz', 'Initials': 'M', 'LastName': 'Jaguszewski', 'Affiliation': 'First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Jarosław D', 'Initials': 'JD', 'LastName': 'Kasprzak', 'Affiliation': 'First Department and Chair of Cardiology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kubica', 'Affiliation': 'Department of Cardiology and Internal Medicine, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Bydgoszcz, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Legutko', 'Affiliation': 'Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, The John Paul II Hospital, Krakow, Poland.'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Leszek', 'Affiliation': 'Department of Heart Failure and Transplantology, National Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Jadwiga', 'Initials': 'J', 'LastName': 'Nessler', 'Affiliation': 'Department of Coronary Disease and Heart Failure, Institute of Cardiology, Jagiellonian University, Medical College, Krakow, Poland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pacileo', 'Affiliation': 'Heart Failure and Cardiac Rehabilitation Unit, Department of Cardiology, AORN dei Colli-Monaldi Hospital, Naples, Italy.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Bożena', 'Initials': 'B', 'LastName': 'Sobkowicz', 'Affiliation': 'Department of Cardiology, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Stępińska', 'Affiliation': 'Department of Intensive Cardiac Therapy, National Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Straburzyńska-Migaj', 'Affiliation': 'First Department of Cardiology, University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Wojakowski', 'Affiliation': 'Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Zawiślak', 'Affiliation': 'Intensive Cardiac Care Unit, University Hospital Krakow, Krakow, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zymliński', 'Affiliation': 'Department of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in medical sciences,['10.1016/j.advms.2021.10.001']
1197,34664662,A Randomized Study of Lenvatinib 18 mg vs 24 mg in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer.,"BACKGROUND


Lenvatinib is a multikinase inhibitor approved to treat radioiodine-refractory differentiated thyroid cancer (RR-DTC) at a starting dose of 24 mg/day. This study explored, in a double-blinded fashion, whether a starting dose of 18 mg/day would provide comparable efficacy with reduced toxicity.
METHODS


Patients with RR-DTC were randomized to lenvatinib 24 mg/day or 18 mg/day. The primary efficacy endpoint was objective response rate as of week 24 (ORRwk24); the odds ratio noninferiority margin was 0.4. The primary safety endpoint was frequency of grade ≥3 treatment-emergent adverse events (TEAEs) as of week 24. Tumors were assessed using RECIST v1.1. TEAEs were monitored and recorded.
RESULTS


The ORRwk24 was 57.3% (95% CI 46.1, 68.5) in the lenvatinib 24-mg arm and 40.3% (95% CI 29.3, 51.2) in the lenvatinib 18-mg arm, with an odds ratio (18/24 mg) of 0.50 (95% CI 0.26, 0.96). As of week 24, the rates of TEAEs grade ≥3 were 61.3% in the lenvatinib 24-mg arm and 57.1% in the lenvatinib 18-mg arm, a difference of -4.2% (95% CI -19.8, 11.4).
CONCLUSION


A starting dose of lenvatinib 18 mg/day did not demonstrate noninferiority compared to a starting dose of 24 mg/day as assessed by ORRwk24 in patients with RR-DTC. The results represent a clinically meaningful difference in ORRwk24. The safety profile was comparable, with no clinically relevant difference between arms. These results support the continued use of the approved starting dose of lenvatinib 24 mg/day in patients with RR-DTC and adjusting the dose as necessary.",2022,"The ORRwk24 was 57.3% (95% confidence interval [CI] 46.1-68.5) in the lenvatinib 24-mg arm and 40.3% (95% CI 29.3-51.2) in the lenvatinib 18-mg arm, with an odds ratio [18/24 mg] of 0.50 (95% CI 0.26-0.96).","['Patients with RR-DTC', 'Refractory Differentiated Thyroid Cancer']","['Lenvatinib 18\xa0mg', 'lenvatinib 24\xa0mg/day or 18\xa0mg/day', 'Radioiodine']","['safety profile', 'objective response rate', 'frequency of grade ≥3 treatment-emergent adverse events (TEAEs', 'rates of TEAEs grade ≥3']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4722172', 'cui_str': 'Primary differentiated carcinoma of thyroid gland'}]","[{'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C2828294', 'cui_str': 'iodide ion I-131'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.351862,"The ORRwk24 was 57.3% (95% confidence interval [CI] 46.1-68.5) in the lenvatinib 24-mg arm and 40.3% (95% CI 29.3-51.2) in the lenvatinib 18-mg arm, with an odds ratio [18/24 mg] of 0.50 (95% CI 0.26-0.96).","[{'ForeName': 'Marcia S', 'Initials': 'MS', 'LastName': 'Brose', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Cancer Center, Jefferson Health, Philadelphia, PA, USA.'}, {'ForeName': 'Yury', 'Initials': 'Y', 'LastName': 'Panaseykin', 'Affiliation': 'A. Tsyb Medical Radiological Research Center, Branch of the NMRС of Radiology, Obninsk, Russian Federation.'}, {'ForeName': 'Bhavana', 'Initials': 'B', 'LastName': 'Konda', 'Affiliation': 'Division of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'de la Fouchardiere', 'Affiliation': 'Medical Oncology Department, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Brett G M', 'Initials': 'BGM', 'LastName': 'Hughes', 'Affiliation': ""Department of Cancer Care Services, Royal Brisbane and Women's Hospital, University of Queensland, Queensland, Australia.""}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Gianoukakis', 'Affiliation': 'The Lundquist Institute at Harbor-UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles/Torrance, CA, USA.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Joo Park', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Romanov', 'Affiliation': 'Department of Head and Neck Tumors, N.N. Blokhin Russian Cancer Research Center, Moscow, Russian Federation.'}, {'ForeName': 'Monika K', 'Initials': 'MK', 'LastName': 'Krzyzanowska', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Leboulleux', 'Affiliation': 'Department of Nuclear Medicine and Endocrine Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Terri A', 'Initials': 'TA', 'LastName': 'Binder', 'Affiliation': 'Oncology Clinical Research, Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Dutcus', 'Affiliation': 'Oncology Clinical Research, Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': 'Biostatistics, Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Taylor', 'Affiliation': 'Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, OR, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab731']
1198,33356905,Addiction history moderates the effect of prefrontal 10-Hz transcranial alternating current stimulation on habitual action selection.,"Individuals with substance use disorders (SUDs) transition more quickly from goal-directed to habitual action-selection, but the neural mechanisms underlying this phenomenon remain unclear. Data from animal models suggest that drugs of abuse can modify the neurocircuits that regulate action-selection, enhancing circuits that drive inflexible, habit-based stimulus-response (S-R) action-selection and weakening circuits that drive flexible, goal-directed actions. Here, we tested the effect of bilateral 10-Hz transcranial alternating current stimulation (10Ηz-tACs) of the dorsolateral prefrontal cortex on action-selection in men and women with a SUD history and an age- and sex-matched control group. We tested the hypothesis that true 10Ηz-tACS versus active sham stimulation would reduce perseverative errors after changed response contingencies for well-learned S-R associations, reflecting reduced habit-based action-selection, specifically in the SUD group. We found that 10 Hz-tACS increased perseverative errors in the control group, but in the SUD group, 10 Hz-tACS effects on perseverative errors depended on substance abuse duration: a longer addiction history was associated with a greater reduction of perseverative errors. These results suggest that 10Ηz-tACs altered circuit level dynamics regulating behavioral flexibility, and provide a foundation for future studies to test stimulation site, frequency, and timing specificity. Moreover, these data suggest that chronic substance abuse is associated with altered circuit dynamics that are ameliorated by 10Ηz-tACs. Determining the generalizability of these effects and their duration merits investigation as a direction for novel therapeutic interventions. These findings are timely based on growing interest in transcranial stimulation methods for treating SUDs. NEW & NOTEWORTHY  Treating the executive dysfunction associated with addiction is hampered by redundancies in pharmacological regulation of different behavioral control circuits. Thus, nonpharmacological interventions hold promise for addiction treatment. Here, we show that, among people with an addiction history, 10-Hz transcranial alternating current stimulation (10Hz-tACS) of the dorsolateral prefrontal cortex can reduce habitual actions. The fact that 10Hz-tACS can regulate behavioral flexibility suggests its possible utility in reducing harmful habitual actions.",2021,"We found that 10 Hz-tACS increased perseverative errors in the control group, but in the SUD group, 10 Hz-tACS effects on perseverative errors depended on substance abuse duration: a longer addiction history was associated with a greater reduction of perseverative errors.","['Individuals with substance use disorders (SUDs) transition', 'men and women with a SUD history and an age- and sex-matched control group', 'people with an addiction history']","['bilateral 10-Hz transcranial alternating current stimulation (10Ηz-tACs', '10-Hz transcranial alternating current stimulation (10Hz-tACS', 'prefrontal 10-Hz transcranial alternating current stimulation', '10Hz-tACS']","['perseverative errors', 'habitual action selection', 'substance abuse duration']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0417638,"We found that 10 Hz-tACS increased perseverative errors in the control group, but in the SUD group, 10 Hz-tACS effects on perseverative errors depended on substance abuse duration: a longer addiction history was associated with a greater reduction of perseverative errors.","[{'ForeName': 'Theresa H', 'Initials': 'TH', 'LastName': 'McKim', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Dove', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Donita L', 'Initials': 'DL', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychiatry, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Fröhlich', 'Affiliation': 'Department of Psychiatry, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Boettiger', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill, North Carolina.'}]",Journal of neurophysiology,['10.1152/jn.00180.2020']
1199,34735776,"Effects of a Partially Supervised Conditioning Program in Cystic Fibrosis: An International Multicenter, Randomized Controlled Trial (ACTIVATE-CF).","Rationale:  The long-term effects of vigorous physical activity (PA) on lung function in cystic fibrosis are unclear.  Objectives:  To evaluate effects of a 12-month partially supervised PA intervention using motivational feedback.  Methods:  In a parallel-arm multicenter randomized controlled trial (ACTIVATE-CF), relatively inactive patients aged at least 12 years were randomly assigned (1:1 ratio) to an intervention group or control group. The intervention group consented to add 3 hours of vigorous PA per week, whereas the control group was asked not to change their PA behavior. Primary endpoint was change in percent predicted FEV 1  (ΔFEV 1 ) at 6 months. Secondary endpoints included PA, exercise capacity, exercise motives, time to first exacerbation and exacerbation rates, quality of life, anxiety, depression, stress, and blood glucose control. Data were analyzed using mixed linear models.  Measurements and Main Results:  A total of 117 patients (40% of target sample size) were randomized to an intervention (n = 60) or control group (n = 57). After 6 months, ΔFEV 1  was significantly higher in the control group compared with the intervention group (2.70% predicted [95% confidence interval, 0.13-5.26];  P  = 0.04). The intervention group reported increased vigorous PA compared with the control group at each study visit, had higher exercise capacity at 6 and 12 months, and higher PA at 12 months. No effects were seen in other secondary outcomes.  Conclusions:  ACTIVATE-CF increased vigorous PA and exercise capacity, with effects carried over for the subsequent 6 months, but resulted in better FEV 1  in the control group.",2022,"The intervention group reported increased vigorous PA compared with the control group at each study visit, had higher exercise capacity at 6 and 12 months, and higher PA at 12 months.","['Cystic Fibrosis', '117 patients (40% of target sample size', 'relatively inactive patients aged ≥12 years']","['vigorous physical activity (PA', 'intervention group or control group', 'partially supervised PA intervention', 'Partially Supervised Conditioning Program']","['exercise capacity', 'vigorous PA', 'change in percent predicted forced expiratory volume in 1s (ΔFEV 1 ', 'ΔFEV 1', 'vigorous PA and exercise capacity', 'PA, exercise capacity, exercise motives, time to first exacerbation and exacerbation rates, quality of life, anxiety, depression, and stress, and blood glucose control']","[{'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",117.0,0.0805112,"The intervention group reported increased vigorous PA compared with the control group at each study visit, had higher exercise capacity at 6 and 12 months, and higher PA at 12 months.","[{'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Hebestreit', 'Affiliation': 'Paediatric Department, University Hospitals Würzburg, Würzburg, Germany.'}, {'ForeName': 'Susi', 'Initials': 'S', 'LastName': 'Kriemler', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schindler', 'Affiliation': 'Swiss Tropical and Public Health Institute, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Stein', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Karila', 'Affiliation': 'Service de Pneumologie et Allergologie Pédiatriques, AP-HP Hôpital Necker Enfants Malades, Université Paris Descartes, Paris, France.'}, {'ForeName': 'Don S', 'Initials': 'DS', 'LastName': 'Urquhart', 'Affiliation': 'Department of Paediatric Respiratory and Sleep Medicine, Royal Hospital for Sick Children, Edinburgh, United Kingdom.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Orenstein', 'Affiliation': ""Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Larry C', 'Initials': 'LC', 'LastName': 'Lands', 'Affiliation': ""Montreal Children's Hospital, McGill University Health Centre, Montreal, Quebec, Canada; and.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Schaeff', 'Affiliation': 'Paediatric Department, University Hospitals Würzburg, Würzburg, Germany.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Eber', 'Affiliation': 'Division of Paediatric Pulmonology and Allergology, Department of Paediatrics and Adolescent Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Radtke', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202106-1419OC']
1200,34740766,Patient-Reported Outcomes in the Acute Phase of the Randomized Hypofractionated Irradiation for Prostate Cancer (HYPRO) Trial.,"PURPOSE


Many patients experience bowel and bladder toxicity during the acute phase of radiation therapy for prostate cancer. Recent literature indicates that hypofractionation (HF) might increase this acute response but little is known on patient-reported outcome during this phase with HF. We evaluated the course of patient-reported acute symptoms during HF versus standard fractionated (SF) radiation therapy within the hypofractionated irradiation for prostate cancer (HYPRO) trial.
METHODS AND MATERIALS


In the HYPRO trial patients were treated with either 64.4 Gy (HF) in 19 fractions (3 times per week) or 78 Gy (SF) in 39 fractions (5 times per week). Normalized total dose for 2 Gy/fractions (NTD 2Gy )for acute toxicity (α/β ratio of 10) for HF was 72.1 Gy with a similar dose rate of 10.2 Gy per week. Among the 794 patients who were previously eligible for acute grade ≥2 toxicity assessment, 717 had filled out ≥1 symptom questionnaires. For each maximum symptom, we scored ""any complaint"" and ""moderate-severe complaint."" Differences were tested by χ 2  test, and associations with clinical factors were tested using logistic regression. Significance was set at P ≤ .008 to adjust for multiple testing.
RESULTS


We observed significantly higher rates of moderate-severe painful defecation (HF 10.8%, SF 5.3%), any mucus discharge (HF 47.1%, SF 37.4%), any rectal blood loss (HF 16.1%, SF 9.3%), increased daily stool frequency ≥4 and ≥6 (HF 34.6%/13.8%, SF 25.6%/7.0%), and any urinary straining (HF 69.9%, SF 58.0%). At 3 months postradiation therapy, rates dropped considerably with similar levels for HF and SF. Hormonal treatment was associated with less acute gastrointestinal symptoms.
CONCLUSION


The increased patient-reported acute rectal symptoms with HF confirmed the previously reported results on acute grade ≥2 rectal toxicity. The increase in bladder symptoms with HF was not identified previously. These observations contradict the NTD 2Gy  calculations. We observed no patterns of persisting complaints with HF after the acute period; therefore, HF is well tolerated and only associated with a temporary increase of symptoms.",2022,"We observed significantly higher rates of moderate-severe painful defecation (HF 10.8%, SF 5.3%), any mucus discharge (HF 47.1%, SF 37.4%), any rectal blood loss (HF 16.1%, SF 9.3%), increased daily stool frequency ≥4 and ≥6 (HF 34.6%/13.8%, SF25.6%/7.0%), and any urinary straining (HF 69.9%, SF 58.0%).","['for prostate cancer', '794 patients who were previously eligible for acute Grade ≥2 toxicity assessment, N=717 had filled out ≥1 symptom questionnaires']","['radiotherapy', 'HF vs standard fractionated (SF) radiotherapy', 'hypofractionation (HF']","['bladder symptoms', 'mucus discharge', 'rates of moderate-severe painful defecation', 'urinary straining', 'acute grade >=2 rectal toxicity', 'acute toxicity', 'bladder toxicity', 'daily stool frequency', 'rectal blood loss', 'acute rectal symptoms']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0333273', 'cui_str': 'Mucus discharge'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0237326', 'cui_str': 'Pain associated with defecation'}, {'cui': 'C0749948', 'cui_str': 'Urinary straining'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0267596', 'cui_str': 'Rectal hemorrhage'}, {'cui': 'C0558921', 'cui_str': 'Rectal symptoms'}]",794.0,0.171569,"We observed significantly higher rates of moderate-severe painful defecation (HF 10.8%, SF 5.3%), any mucus discharge (HF 47.1%, SF 37.4%), any rectal blood loss (HF 16.1%, SF 9.3%), increased daily stool frequency ≥4 and ≥6 (HF 34.6%/13.8%, SF25.6%/7.0%), and any urinary straining (HF 69.9%, SF 58.0%).","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Sinzabakira', 'Affiliation': 'Department of Radiotherapy, Erasmus MC Cancer Institute, Rotterdam, The Netherlands; Rwanda Cancer Centre, Rwanda Military Hospital, Kigali, Rwanda.'}, {'ForeName': 'Wilma D', 'Initials': 'WD', 'LastName': 'Heemsbergen', 'Affiliation': 'Department of Radiotherapy, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. Electronic address: w.heemsbergen@erasmusmc.nl.'}, {'ForeName': 'Floris J', 'Initials': 'FJ', 'LastName': 'Pos', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Incrocci', 'Affiliation': 'Department of Radiotherapy, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.10.139']
1201,34740588,Use of Patient-Reported Outcomes Measurement Information System Pediatric Measures as Clinical Trial Endpoints: Experience from a Multicenter Pragmatic Trial in Children with Crohn's Disease.,"OBJECTIVES


To evaluate whether Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric patient-reported outcome (PRO) measures can serve as valid endpoints in a clinical trial of a chronic pediatric illness.
STUDY DESIGN


We evaluated the responsiveness of PROMIS pediatric measures collected through the Clinical Outcomes of Methotrexate Binary Therapy in Practice (COMBINE) trial, a multicenter, randomized, double-blind, placebo-controlled, pragmatic clinical trial in pediatric patients with Crohn's disease (CD). We examined the relationships between changes in PROMIS pediatric measures and changes in disease activity by evaluating PRO score changes among patients who did and patients who did not experience improvement in disease activity.
RESULTS


Participants included 266 children and adolescents with CD from a total of 35 institutions. Over the course of follow-up, participants showed improvement in most PRO domains, with the largest effect sizes observed for the clinically improved group. Patients who maintained steroid-free remission showed significantly lower PRO scores for the Pain Interference, Fatigue, and inflammatory bowel disease (IBD) Symptoms domains and higher scores for the Positive Affect domain.
CONCLUSIONS


This study demonstrates the responsiveness of the PROMIS pediatric measures of Fatigue and Pain Interference as study endpoints in a large, multicenter pragmatic trial in pediatric CD, extending a growing body of research supporting the use of PROMIS pediatric measures as reliable PRO endpoints for clinical trials.",2022,"Patients who maintained steroid-free remission showed significantly lower PRO scores for Pain Interference, Fatigue and IBD Symptom and higher Positive Affect scores.
","['Children', 'Participants included 266 children and adolescents with CD from a total of 35 institutions', 'pediatric patients with CD']","['placebo', 'Methotrexate Binary Therapy']","['disease activity', 'PRO scores for Pain Interference, Fatigue and IBD Symptom and higher Positive Affect scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",266.0,0.462895,"Patients who maintained steroid-free remission showed significantly lower PRO scores for Pain Interference, Fatigue and IBD Symptom and higher Positive Affect scores.
","[{'ForeName': 'Talya L', 'Initials': 'TL', 'LastName': 'Miller', 'Affiliation': 'Department of Pediatrics, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC. Electronic address: Talya.Lepow.Miller@gmail.com.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Schuchard', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Carle', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH; Department of Psychology, University of Cincinnati College of Arts and Sciences, Cincinnati, OH.""}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Forrest', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Kappelman', 'Affiliation': 'Department of Pediatrics, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2021.10.053']
1202,34740836,Effect of multiple sessions of photodynamic therapy on bone regeneration around dental implants among patients with peri‑implantitis.,"OBJECTIVE


The aim of the present study was to assess the effect of multiple sessions of antimicrobial photodynamic therapy (aPDT) on bone regeneration around dental implants among patients with peri‑implantitis.
METHODS


Patients with peri‑implantitis were included. Therapeutically, patients were randomly divided into 4 groups: (a) Group-I: Mechanical debridement (MD) alone; (b) Group-II: MD at baseline followed by a single session of adjunct a PDT; (c) Group-III: MD at baseline followed by aPDT at baseline and at 3-months of follow-up; and Group-IV: MD at baseline followed by aPDT at baseline and at 3- and 6-months of follow-up. Demographic data was collected and peri‑implant clinical (plaque index [PI], gingival index [GI], and probing depth [PD]) and radiographic (crestal bone loss [CBL]) parameters were assessed at baseline and after 9 months. Sample-size estimation was done on data from a pilot investigation and group comparisons were done using one-way analysis of variance and Bonferroni post-hoc adjustment tests. Level of significance was set at P<0.01.
RESULTS


Twenty-two, 22, 22 and 22 patients with peri‑implantitis were enrolled in groups -I, -II, -III and -IV. The mean age of individuals in groups -I, -II, -III and -IV were 59.2 ± 5.3, 60.5 ± 2.8, 59.6 ± 3.1 and 58.7 ± 0.8 years, respectively. Compared with Group-I, there was a statistically significant reduction in PI (P<0.01), GI (P<0.01) and PD (P<0.01) in all groups at 9-months follow-up. There was no significant difference in PI, GI and PD in groups -II, -III and -IV at 9-months follow-up. There was no statistically significant difference in CBL in all groups at baseline and at 9-months-follow-up.
CONCLUSION


The use of aPDT as an adjunct to MD reduces the severity of peri‑implant mucositis but does not contribute towards bone regeneration in peri‑implant osseous defects.",2022,"There was no statistically significant difference in CBL in all groups at baseline and at 9-months-follow-up.
","['Twenty-two, 22, 22 and 22 patients with peri-implantitis', 'patients with peri-implantitis', 'Patients with peri-implantitis were included', 'The mean age of individuals in groups -I, -II, -III and -IV were 59.2 ± 5.3, 60.5 ± 2.8, 59.6 ± 3.1 and 58.7 ± 0.8 years, respectively']","['photodynamic therapy', 'aPDT', 'antimicrobial photodynamic therapy (aPDT', 'Mechanical debridement (MD) alone']","['MD', 'PI, GI and PD', 'bone regeneration', 'peri-implant clinical (plaque index [PI], gingival index [GI], and probing depth [PD]) and radiographic (crestal bone loss [CBL', 'CBL', 'PI (P<0.01), GI (P<0.01) and PD']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}]",,0.0331162,"There was no statistically significant difference in CBL in all groups at baseline and at 9-months-follow-up.
","[{'ForeName': 'Shatha Subhi', 'Initials': 'SS', 'LastName': 'ALHarthi', 'Affiliation': 'Department of Preventive Dental Sciences, College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Nujud Zayed', 'Initials': 'NZ', 'LastName': 'Alamry', 'Affiliation': 'Department of Preventive Dental Sciences, College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Munerah Saleh', 'Initials': 'MS', 'LastName': 'BinShabaib', 'Affiliation': 'Department of Preventive Dental Sciences, College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia. Electronic address: Msbinshabaib@pnu.edu.sa.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102612']
1203,34741513,Recruitment in a research study via chatbot versus telephone outreach: a randomized trial at a minority-serving institution.,"Chatbots are software applications to simulate a conversation with a person. The effectiveness of chatbots in facilitating the recruitment of study participants in research, specifically among racial and ethnic minorities, is unknown. The objective of this study is to compare a chatbot versus telephone-based recruitment in enrolling research participants from a predominantly minority patient population at an urban institution. We randomly allocated adults to receive either chatbot or telephone-based outreach regarding a study about vaccine hesitancy. The primary outcome was the proportion of participants who provided consent to participate in the study. In 935 participants, the proportion who answered contact attempts was significantly lower in the chatbot versus telephone group (absolute difference -21.8%; 95% confidence interval [CI] -27.0%, -16.5%; P < 0.001). The consent rate was also significantly lower in the chatbot group (absolute difference -3.4%; 95% CI -5.7%, -1.1%; P = 0.004). However, among participants who answered a contact attempt, the difference in consent rates was not significant. In conclusion, the consent rate was lower with chatbot compared to telephone-based outreach. The difference in consent rates was due to a lower proportion of participants in the chatbot group who answered a contact attempt.",2021,"In 935 participants, the proportion who answered contact attempts was significantly lower in the chatbot versus telephone group (absolute difference -21.8%; 95% confidence interval [CI] -27.0%, -16.5%; P < 0.001).",['enrolling research participants from a predominantly minority patient population at an urban institution'],['chatbot or telephone-based outreach regarding a study about vaccine hesitancy'],"['consent rates', 'proportion who answered contact attempts', 'consent rate']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine'}]","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",935.0,0.329597,"In 935 participants, the proportion who answered contact attempts was significantly lower in the chatbot versus telephone group (absolute difference -21.8%; 95% confidence interval [CI] -27.0%, -16.5%; P < 0.001).","[{'ForeName': 'Yoo Jin', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Breathe Chicago Center, Division of Pulmonary, Critical Care, Sleep, and Allergy, University of Illinois Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'DeLisa', 'Affiliation': 'Breathe Chicago Center, Division of Pulmonary, Critical Care, Sleep, and Allergy, University of Illinois Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Yu-Che', 'Initials': 'YC', 'LastName': 'Chung', 'Affiliation': 'Breathe Chicago Center, Division of Pulmonary, Critical Care, Sleep, and Allergy, University of Illinois Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Shapiro', 'Affiliation': 'Department of Pharmacy Practice, College of Pharmacy, University of Illinois Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Subhash K', 'Initials': 'SK', 'LastName': 'Kolar Rajanna', 'Affiliation': 'Center for Clinical and Translational Science, University of Illinois Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Barbour', 'Affiliation': 'Center for Clinical and Translational Science, University of Illinois Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Loeb', 'Affiliation': 'Center for Clinical and Translational Science, University of Illinois Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'QliqSOFT, Inc., Dallas, Texas, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Daley', 'Affiliation': 'QliqSOFT, Inc., Dallas, Texas, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Skowlund', 'Affiliation': 'QliqSOFT, Inc., Dallas, Texas, USA.'}, {'ForeName': 'Jerry A', 'Initials': 'JA', 'LastName': 'Krishnan', 'Affiliation': 'Breathe Chicago Center, Division of Pulmonary, Critical Care, Sleep, and Allergy, University of Illinois Chicago, Chicago, Illinois, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocab240']
1204,34656406,Effectiveness of telemedicine in patients with heart failure according to frailty phenotypes: Insights from the iCOR randomised controlled trial.,"BACKGROUND


The potential impact of telemedicine (TM) in the monitoring of patients with heart failure (HF) is still uncertain particularly in the frailest patients. The aim of this study was to define the efficacy of a TM-based managed care solution across different HF patient frailty phenotypes.
METHODS


We performed a clustering analysis on the basis of 8 frailty-related dimensions to the HF-patients included in the 'insuficiència Cardíaca Optimització Remota' (iCOR) randomised study comparing TM vs. usual care (UC) in HF patients. The primary study endpoint was the incidence of a non-fatal HF event after 6 months of inclusion. The healthcare-related costs in each study group and cluster were also evaluated. The event rates of primary and secondary study endpoints were calculated for each cluster. Cox proportional-hazards regression models were used to evaluate the effect of cluster, treatment group and the interaction term cluster by treatment group on study endpoints.
RESULTS


5 different frailty phenotypes were identified. The positive effect of TM compared to UC strategy was consistent across all frailty phenotypes (p-value for interaction 0.711). The risk of experiencing a primary event was significantly lower in patients that underwent allocation to the TM arm compared to UC (p-value = 0.016). Ultimately, the healthcare costs were significantly reduced in patients allocated to the TM compared to UC in all 5 frailty phenotypes (all p-value < 0.05).
CONCLUSIONS


Non-invasive TM-based follow-up tools are effective compared to UC follow-up in preventing HF events in the early post-discharge period, regardless of the 5 frailty phenotypes.",2022,"Ultimately, the healthcare costs were significantly reduced in patients allocated to the TM compared to UC in all 5 frailty phenotypes (all p-value < 0.05).
","[""8 frailty-related dimensions to the HF-patients included in the 'insuficiència Cardíaca Optimització Remota' (iCOR) randomised study comparing TM vs. usual care (UC) in HF patients"", 'patients with heart failure (HF', 'patients with heart failure according to frailty phenotypes']","['telemedicine (TM', 'telemedicine', 'TM-based managed care solution', 'TM']","['incidence of a non-fatal HF event', 'risk of experiencing a primary event', 'healthcare costs']","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}]",,0.0449279,"Ultimately, the healthcare costs were significantly reduced in patients allocated to the TM compared to UC in all 5 frailty phenotypes (all p-value < 0.05).
","[{'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Yun', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Bio-Heart Cardiovascular Diseases Research Group, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain; Department of Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Enjuanes', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Bio-Heart Cardiovascular Diseases Research Group, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain; Department of Cardiology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Calero-Molina', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Bio-Heart Cardiovascular Diseases Research Group, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain; Department of Cardiology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Encarnación', 'Initials': 'E', 'LastName': 'Hidalgo', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Bio-Heart Cardiovascular Diseases Research Group, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain; Department of Cardiology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'José', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Bio-Heart Cardiovascular Diseases Research Group, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain; Department of Cardiology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Calvo', 'Affiliation': ""Bio-Heart Cardiovascular Diseases Research Group, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain; Department of Cardiology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Faculty of medicine and Health Sciences, School of Nursing, University of Barcelona (UB), Barcelona, Spain.""}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Verdú-Rotellar', 'Affiliation': 'Heart Diseases Biomedical Research Group, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain; School of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain; Jordi Gol Primary Care Research Institute, Catalan Institute of Heath, Barcelona, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Garcimartín', 'Affiliation': 'Heart Diseases Biomedical Research Group, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain; Outpatient Clinics, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain; Escuela Superior de Enfermería del Mar, Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chivite', 'Affiliation': ""Department of Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Formiga', 'Affiliation': ""Department of Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Jiménez-Marrero', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Bio-Heart Cardiovascular Diseases Research Group, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain; Department of Cardiology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Department of Cardiology, Cardio-Oncology Unit, Bellvitge University Hospital and Catalan Institute of Oncology, L'Hospitalet del Llobregat, Barcelona, Spain.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Garay', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Bio-Heart Cardiovascular Diseases Research Group, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain; Department of Cardiology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Department of Cardiology, Cardio-Oncology Unit, Bellvitge University Hospital and Catalan Institute of Oncology, L'Hospitalet del Llobregat, Barcelona, Spain.""}, {'ForeName': 'Lídia', 'Initials': 'L', 'LastName': 'Alcoberro', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Bio-Heart Cardiovascular Diseases Research Group, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain; Department of Cardiology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Moliner', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Bio-Heart Cardiovascular Diseases Research Group, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain; Department of Cardiology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Department of Cardiology, Cardio-Oncology Unit, Bellvitge University Hospital and Catalan Institute of Oncology, L'Hospitalet del Llobregat, Barcelona, Spain.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Corbella', 'Affiliation': ""Department of Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain; Hestia Chair in Integrated Health and Social Care, School of Medicine, Universitat Internacional de Catalunya, Barcelona, Spain.""}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comín-Colet', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Bio-Heart Cardiovascular Diseases Research Group, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain; Department of Cardiology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Department of Clinical Sciences, School of Medicine, University of Barcelona (UB), Barcelona, Spain. Electronic address: jcomin@bellvitgehospital.cat.""}]",European journal of internal medicine,['10.1016/j.ejim.2021.09.021']
1205,34664427,"Safety, Tolerability, and Pharmacokinetics of Mevidalen (LY3154207), a Centrally Acting Dopamine D1 Receptor-Positive Allosteric Modulator, in Patients With Parkinson Disease.","Mevidalen (LY3154207) is a positive allosteric modulator of the dopamine D1 receptor that enhances the affinity of dopamine for the D1 receptor. The safety, tolerability, motor effects, and pharmacokinetics of mevidalen were studied in patients with Parkinson disease. Mevidalen or placebo was given once daily for 14 days to 2 cohorts of patients (cohort 1, 75 mg; cohort 2, titration from 15 to 75 mg). For both cohorts, the median time to maximum concentration for mevidalen plasma concentration was about 2 hours, the apparent steady-state clearance was 20-25 L/h, and mevidalen plasma concentrations were similar between the 1st and 14th administration in cohort 1, indicating minimal accumulation upon repeated dosing. Mevidalen was well tolerated, and most treatment-emergent adverse events were mild. Blood pressure and pulse rate increased when taking mevidalen, but there was considerable overlap with patients taking placebo, and vital signs normalized with repeated dosing. In the Movement Disorder Society-United Parkinson's Disease Rating Scale, all patients taking mevidalen showed a better motor examination sub-score on day 6 compared to only some patients in the placebo group. These data support examining mevidalen for symptomatic treatment of patients with Parkinson disease and Lewy body dementia.",2022,"In the Movement Disorder Society-United Parkinson's Disease Rating Scale, all patients taking mevidalen showed a better motor examination sub-score on day 6 compared to only some patients in the placebo group.","['patients with Parkinson disease and Lewy body dementia', 'Patients With Parkinson Disease', 'patients with Parkinson disease']",['placebo'],"['motor examination sub-score', 'Safety, Tolerability, and Pharmacokinetics of Mevidalen (LY3154207', 'mevidalen plasma concentrations', 'median time to maximum concentration for mevidalen plasma concentration', 'Blood pressure and pulse rate', 'safety, tolerability, motor effects, and pharmacokinetics of mevidalen']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.180961,"In the Movement Disorder Society-United Parkinson's Disease Rating Scale, all patients taking mevidalen showed a better motor examination sub-score on day 6 compared to only some patients in the placebo group.","[{'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Wilbraham', 'Affiliation': 'Eli Lilly and Company, Bracknell, UK.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Biglan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Kjell A', 'Initials': 'KA', 'LastName': 'Svensson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pugh', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ardayfio', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Kielbasa', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.1039']
1206,34665856,Salbutamol Increases Leg Glucose Uptake and Metabolic Rate but not Muscle Glycogen Resynthesis in Recovery From Exercise.,"CONTEXT


Exercise blunts the effect of beta2-agonists on peripheral glucose uptake and energy expenditure. Whether such attenuation extends into recovery is unknown.
OBJECTIVE


To examine the effect of a beta2-agonist on leg glucose uptake and metabolic rate in recovery from exercise.
METHODS


Using leg arteriovenous balance technique and analyses of thigh muscle biopsies, we investigated the effect of a beta2-agonist (24 mg of oral salbutamol) vs placebo on leg glucose, lactate, and oxygen exchange before and during quadriceps exercise, and 0.5 to 5 hours in recovery from quadriceps exercise, as well as on muscle glycogen resynthesis and activity in recovery. Twelve healthy, lean, young men participated.
RESULTS


Before exercise, leg glucose uptake was 0.42 ± 0.12 and 0.20 ± 0.02 mmol × min-1 (mean ± SD) for salbutamol and placebo (P = .06), respectively, while leg oxygen consumption was around 2-fold higher (P < .01) for salbutamol than for placebo (25 ± 3 vs 14 ± 1 mL × min-1). No treatment differences were observed in leg glucose uptake, lactate release, and oxygen consumption during exercise. But in recovery, cumulated leg glucose uptake, lactate release, and oxygen consumption was 21 mmol (95% CI 18-24, P = .018), 19 mmol (95% CI 16-23, P < .01), and 1.8 L (95% CI 1.6-2.0, P < .01) higher for salbutamol than for placebo, respectively. Muscle glycogen content was around 30% lower (P < .01) for salbutamol than for placebo in recovery, whereas no treatment differences were observed in muscle glycogen resynthesis or glycogen synthase activity.
CONCLUSION


Exercise blunts the effect of beta2-agonist salbutamol on leg glucose uptake, but this attenuation diminishes in recovery. Salbutamol increases leg lactate release in recovery, which may relate to glycolytic trafficking due to excessive myocellular glucose uptake.",2022,"Muscle glycogen content was around 30% lower (P<0.01) for salbutamol than placebo in recovery, whereas no treatment differences were observed in muscle glycogen resynthesis or glycogen synthase activity.
",['Twelve healthy lean young men'],"['thigh muscle biopsies', 'Salbutamol', 'beta2-agonist (24\xa0mg oral salbutamol', 'salbutamol and placebo', 'placebo']","['muscle glycogen resynthesis or glycogen synthase activity', 'leg glucose uptake and metabolic rate', 'Muscle glycogen content', 'leg lactate release', 'peripheral glucose uptake and energy expenditure', 'leg oxygen consumption', 'leg glucose uptake, lactate release, and oxygen consumption', 'leg glucose, lactate, and oxygen exchange', 'leg glucose uptake', 'recovery, cumulated leg glucose uptake, lactate release, and oxygen consumption']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0224416', 'cui_str': 'Skeletal muscle structure of thigh'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0017932', 'cui_str': 'Glycogen (starch) synthase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",12.0,0.128835,"Muscle glycogen content was around 30% lower (P<0.01) for salbutamol than placebo in recovery, whereas no treatment differences were observed in muscle glycogen resynthesis or glycogen synthase activity.
","[{'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Onslev', 'Affiliation': 'Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Thomassen', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Wojtaszewski', 'Affiliation': 'Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bangsbo', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Hostrup', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, 2100 Copenhagen, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab752']
1207,34665853,Integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training for Negative Symptoms of Psychosis: Effects in a Pilot Randomized Controlled Trial.,"OBJECTIVE


Negative symptoms and cognitive impairment in schizophrenia (SZ) remain unmet treatment needs as they are highly prevalent, associated with poor functional outcomes, and resistant to pharmacologic treatment. The current pilot randomized controlled trial examined the efficacy of an integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training (CBSST-CCT) intervention compared to Goal-focused Supportive Contact (SC) on negative symptoms and cognitive performance.
METHODS


Fifty-five adults with SZ or schizoaffective disorder with moderate-to-severe negative symptoms were randomized to receive 25 twice-weekly, 1-h manualized group sessions (12.5 weeks total duration) of either CBSST-CCT or SC delivered by master's level clinicians in five community settings. Assessments of negative symptom severity (primary outcomes) and neuropsychological performance, functional capacity, social skills performance, and self-reported functional ability/everyday functioning, psychiatric symptom severity, and motivation (secondary outcomes) were administered at baseline, mid-treatment, post-treatment, and 6-month follow-up.
RESULTS


Mixed-effects models using baseline, mid-treatment, and post-treatment data demonstrated significant CBSST-CCT-associated effects on negative symptom severity, as assessed by the Scale for the Assessment of Negative Symptoms (p = .049, r = 0.22), with improvements in diminished motivation driving this effect (p = .037, r = 0.24). The CBSST-CCT group also demonstrated improved verbal learning compared to SC participants (p = .026, r = 0.36). The effects of CBSST-CCT appeared to be durable at 6-month follow-up.
CONCLUSIONS


CBSST-CCT improved negative symptom severity and verbal learning in high-negative-symptom individuals relative to SC. CBSST-CCT warrants larger investigations to examine its efficacy in treating negative symptoms, along with other symptoms, cognition, and, ultimately, real-world functional outcomes. Clinical Trial registration number NCT02170051.",2022,"The CBSST-CCT group also demonstrated improved verbal learning compared to SC participants (p = .026, r = 0.36).","['Fifty-five adults with SZ or schizoaffective disorder with moderate-to-severe negative symptoms', 'Negative Symptoms of Psychosis']","['CBSST-CCT', 'CBSST-CCT or SC', 'Integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training', 'Goal-focused Supportive Contact (SC', 'integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training (CBSST-CCT) intervention']","['verbal learning', 'negative symptom severity', 'negative symptom severity (primary outcomes) and neuropsychological performance, functional capacity, social skills performance, and self-reported functional ability/everyday functioning, psychiatric symptom severity, and motivation (secondary outcomes', 'negative symptom severity and verbal learning']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150777', 'cui_str': 'Social skills training'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",55.0,0.0728149,"The CBSST-CCT group also demonstrated improved verbal learning compared to SC participants (p = .026, r = 0.36).","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Granholm', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Twamley', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Zanjbeel', 'Initials': 'Z', 'LastName': 'Mahmood', 'Affiliation': 'SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego, CA, USA.'}, {'ForeName': 'Amber V', 'Initials': 'AV', 'LastName': 'Keller', 'Affiliation': 'SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego, CA, USA.'}, {'ForeName': 'Hannah C', 'Initials': 'HC', 'LastName': 'Lykins', 'Affiliation': 'Research Service and Center of Excellence for Stress and Mental Health, VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Parrish', 'Affiliation': 'SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego, CA, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Thomas', 'Affiliation': 'Psychology Department, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Perivoliotis', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Holden', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.'}]",Schizophrenia bulletin,['10.1093/schbul/sbab126']
1208,34747093,Effects of group psychological counselling on transition shock in newly graduated nurses: A quasi-experimental study.,"AIM


This study examined the effects of group psychological counselling on transition shock in newly graduated nurses.
BACKGROUND


Newly graduated nurses are often faced with transition shock as they enter the workforce. Helping them adapt to the new work environment and role as quickly as possible is an important goal for nursing managers.
METHOD


This prospective, parallel-group, quasi-experimental trial enrolled 71 newly graduated nurses who were randomly assigned to the intervention (n = 38) or control (n = 41) group. In addition to routine hospital training, the intervention group received psychological counselling. Participants were evaluated with the Transition Shock Scale of Newly Graduated Nurses before (pre) and after (post) the training with or without intervention.
RESULTS


The total score and score on each dimension of the scale were decreased after the intervention (P < .05); control subjects showed no difference between pre- and post-scores. The total score and score on each dimension were higher in the control group than in the intervention group (P < .05).
CONCLUSION


Psychological counselling alleviates transition shock in newly graduated nurses entering the workforce.
IMPLICATIONS FOR NURSING MANAGEMENT


Nursing managers can introduce group psychological counselling into their training programmes to increase the job readiness of newly graduated nurses.",2022,The total score and score on each dimension of the scale were decreased after the intervention (P<0.05); control subjects showed no difference between pre and post scores.,"['newly graduated nurses entering the workforce', 'parallel-group, quasi-experimental trial enrolled 71 newly graduated nurses, who were randomly assigned to the intervention (n=38) or control (n=41) group', 'Participants were evaluated with the Transition Shock Scale of Newly Graduated Nurses before (pre) and after (post) the training with or without intervention', 'newly graduated nurses']","['psychological counseling', 'Psychological counseling alleviates transition shock']","['total score and score on each dimension', 'total score and score on each dimension of the scale']","[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0474178', 'cui_str': 'Psychological counseling'}, {'cui': 'C0036974', 'cui_str': 'Shock'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",71.0,0.0115617,The total score and score on each dimension of the scale were decreased after the intervention (P<0.05); control subjects showed no difference between pre and post scores.,"[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Nursing Department, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, China.'}, {'ForeName': 'Suyuan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Urology Department, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, China.'}, {'ForeName': 'Wenxia', 'Initials': 'W', 'LastName': 'Bian', 'Affiliation': 'Thyroid and Breast Surgery Department, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, China.'}, {'ForeName': 'Meifeng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Gastroenterology Department, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, Nursing Department, Nanjing Medical University, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Interventional Radiology Department, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, China.'}]",Journal of nursing management,['10.1111/jonm.13506']
1209,34656740,Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study.,"BACKGROUND


Adjuvant abemaciclib combined with endocrine therapy (ET) previously demonstrated clinically meaningful improvement in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) in hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer at the second interim analysis, however follow-up was limited. Here, we present results of the prespecified primary outcome analysis and an additional follow-up analysis.
PATIENTS AND METHODS


This global, phase III, open-label trial randomized (1 : 1) 5637 patients to adjuvant ET for ≥5 years ± abemaciclib for 2 years. Cohort 1 enrolled patients with ≥4 positive axillary lymph nodes (ALNs), or 1-3 positive ALNs and either grade 3 disease or tumor ≥5 cm. Cohort 2 enrolled patients with 1-3 positive ALNs and centrally determined high Ki-67 index (≥20%). The primary endpoint was IDFS in the intent-to-treat population (cohorts 1 and 2). Secondary endpoints were IDFS in patients with high Ki-67, DRFS, overall survival, and safety.
RESULTS


At the primary outcome analysis, with 19 months median follow-up time, abemaciclib + ET resulted in a 29% reduction in the risk of developing an IDFS event [hazard ratio (HR) = 0.71, 95% confidence interval (CI) 0.58-0.87; nominal P = 0.0009]. At the additional follow-up analysis, with 27 months median follow-up and 90% of patients off treatment, IDFS (HR = 0.70, 95% CI 0.59-0.82; nominal P < 0.0001) and DRFS (HR = 0.69, 95% CI 0.57-0.83; nominal P < 0.0001) benefit was maintained. The absolute improvements in 3-year IDFS and DRFS rates were 5.4% and 4.2%, respectively. Whereas Ki-67 index was prognostic, abemaciclib benefit was consistent regardless of Ki-67 index. Safety data were consistent with the known abemaciclib risk profile.
CONCLUSION


Abemaciclib + ET significantly improved IDFS in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer, with an acceptable safety profile. Ki-67 index was prognostic, but abemaciclib benefit was observed regardless of Ki-67 index. Overall, the robust treatment benefit of abemaciclib extended beyond the 2-year treatment period.",2021,"The absolute improvement in 3-year IDFS and DRFS rates were 5.4% and 4.2%, respectively.","['High-Risk Early Breast Cancer', 'Cohort 2 enrolled patients with 1-3 positive ALN and centrally determined high Ki-67 index (≥20', '5637 patients to adjuvant ET for ≥5 years ', 'Cohort 1 enrolled patients with ≥4 positive axillary lymph nodes (ALN), or 1-3 positive ALN and either Grade 3 disease or tumor ≥5 cm']","['Adjuvant Abemaciclib Combined With Endocrine Therapy', 'Abemaciclib+ET', 'endocrine therapy (ET']","['IDFS in patients with high Ki-67, DRFS, overall survival, and safety', 'Ki-67 index', 'DRFS', '3-year IDFS and DRFS rates', 'invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS', 'IDFS', 'risk of developing an IDFS event']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",1.0,0.409815,"The absolute improvement in 3-year IDFS and DRFS rates were 5.4% and 4.2%, respectively.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Breast Center, Department of OB & GYN and CCC Munich, LMU University Hospital, Munich, Germany. Electronic address: Nadia.Harbeck@med.uni-muenchen.de.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'University of Pittsburgh/UPMC, NSABP Foundation, Pittsburgh, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Universidad Complutense, CIBERONC, GEICAM, Madrid, Spain.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Z M', 'Initials': 'ZM', 'LastName': 'Shao', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Huang', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'G G', 'Initials': 'GG', 'LastName': 'Jaliffe', 'Affiliation': 'Grupo Medico Camino S.C., Mexico City, Mexico.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tryakin', 'Affiliation': 'N.N.Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Mayo Clinic, Rochester, USA.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Department of Medicine (Hematology/Oncology), University of California San Francisco, San Francisco, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Senkus', 'Affiliation': 'Department of Oncology & Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Testa', 'Affiliation': ""Instituto D'Or de Pesquisa e Ensino (IDOR), Sao Paulo, Brazil.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Andersson', 'Affiliation': 'Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Del Mastro', 'Affiliation': 'IRCSS Ospedale Policlinico San Martino, UO Breast Unit, Genoa, Italy; Università di Genova, Department of Internal Medicine and Medical Specialties (DIM), Genoa, Italy.'}, {'ForeName': 'G G', 'Initials': 'GG', 'LastName': 'Steger', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kreipe', 'Affiliation': 'Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'Clin. Pesq. e Centro São Paulo, São Paulo, Brazil.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei Cancer Center, Seoul, Korea.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Guarneri', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padua, Italy; Istituto Oncologico Veneto IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': ""International Breast Cancer Center (IBCC), Madrid & Barcelona, and Vall d'Hebron Institute of Oncology, Barcelona, Spain; Universidad Europea de Madrid, Faculty of Biomedical and Health Sciences, Department of Medicine, Madrid, Spain.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hamilton', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'André', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wei', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Barriga', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sherwood', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Forrester', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Munoz', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shahir', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'San Antonio', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Nabinger', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'S R D', 'Initials': 'SRD', 'LastName': 'Johnston', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.09.015']
1210,34665230,Real ileal amino acid digestibility of pea protein compared to casein in healthy humans: a randomized trial.,"BACKGROUND


It is necessary to propose plant alternatives to animal proteins that are of good nutritional quality. Pea is a good candidate owing to its high protein content and its well-balanced amino acid (AA) profile.
OBJECTIVES


This study aimed to assess the real ileal AA and nitrogen digestibility (RIDAA and RIDN) of pea protein isolate as compared to milk casein in humans. It also aimed to evaluate their nutritional quality through calculation of the digestible indispensable amino acid score (DIAAS) and to determine the net postprandial protein utilization (NPPU).
METHODS


Fifteen healthy volunteers were included in a randomized, single-blinded, 2-arm, parallel-design trial. They were equipped with a naso-ileal tube. They ingested the test meals, which consisted of 9 successive portions of mashed potatoes containing either pea protein or casein, intrinsically labeled with nitrogen 15. Ileal content, plasma, and urine samples were collected regularly over an 8-h postprandial period.
RESULTS


The mean RIDAA values were 93.6% ± 2.9% for pea protein and 96.8% ± 1.0% for casein, with no difference between the sources (P = 0.22). Leucine, valine, lysine, and phenylalanine were significantly less digestible in pea than in casein. The RIDN values were 92.0% ± 2.7% and 94.0% ± 1.7% for pea protein and casein, respectively, and were not different (P = 0.11). The DIAAS was 1.00 for pea protein and 1.45 for casein. The NPPU was 71.6% ± 6.2% and 71.2% ± 4.9% for pea protein and casein, respectively (P = 0.88).
CONCLUSIONS


Although some AAs are less digestible in pea protein than in casein, the real ileal digestibility and the NPPU were not different. The DIAAS of 1.00 obtained for pea protein demonstrated its ability to meet all AA requirements. This study shows the potential of pea isolate as a high-quality protein. This study was registered at clinicaltrials.gov as NCT04072770.",2022,"Leucine, valine, lysine and phenylalanine were significantly less digestible in pea than in casein.","['healthy humans', 'Fifteen healthy volunteers', 'milk casein in humans']","['pea protein compared to casein', 'pea protein or casein, intrinsically labelled with 15N. Ileal content, plasma and urine samples were collected regularly over an 8 h postprandial period']","['real ileal AA and nitrogen digestibility (RIDAA and RIDN', 'Mean RIDAA', 'Leucine, valine, lysine and phenylalanine']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C2720503', 'cui_str': 'casein allergenic extract'}]","[{'cui': 'C3535674', 'cui_str': 'Pea Proteins'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}]","[{'cui': 'C0020885', 'cui_str': 'Ileal structure'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}]",15.0,0.136774,"Leucine, valine, lysine and phenylalanine were significantly less digestible in pea than in casein.","[{'ForeName': 'Florence M', 'Initials': 'FM', 'LastName': 'Guillin', 'Affiliation': 'Université Paris-Saclay, AgroParisTech, INRAE, UMR PNCA, Paris, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Gaudichon', 'Affiliation': 'Université Paris-Saclay, AgroParisTech, INRAE, UMR PNCA, Paris, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Guérin-Deremaux', 'Affiliation': 'Roquette, Lestrem, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lefranc-Millot', 'Affiliation': 'Roquette, Lestrem, France.'}, {'ForeName': 'Gheorghe', 'Initials': 'G', 'LastName': 'Airinei', 'Affiliation': 'Université Paris-Saclay, AgroParisTech, INRAE, UMR PNCA, Paris, France.'}, {'ForeName': 'Nadezda', 'Initials': 'N', 'LastName': 'Khodorova', 'Affiliation': 'Université Paris-Saclay, AgroParisTech, INRAE, UMR PNCA, Paris, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Benamouzig', 'Affiliation': 'Université Paris-Saclay, AgroParisTech, INRAE, UMR PNCA, Paris, France.'}, {'ForeName': 'Pierre-Henri', 'Initials': 'PH', 'LastName': 'Pomport', 'Affiliation': 'Ferme Expérimentale AgroParisTech, Thiverval-Grignon, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': ""Unité Expérimentale du Domaine d'Epoisses, INRAE, U2E, Bretenière, France.""}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Calvez', 'Affiliation': 'Université Paris-Saclay, AgroParisTech, INRAE, UMR PNCA, Paris, France.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab354']
1211,34669935,Interaction between rs10830962 polymorphism in MTNR1B and lifestyle intervention on maternal and neonatal outcomes: secondary analyses of the DALI lifestyle randomized controlled trial.,"BACKGROUND


Interactions between polymorphisms of the melatonin receptor 1B (MTNR1B) gene and lifestyle intervention for gestational diabetes have been described. Whether these are specific for physical activity or the healthy eating intervention is unknown.
OBJECTIVES


The aim was to assess the interaction between MTNR1B rs10830962 and rs10830963 polymorphisms and lifestyle interventions during pregnancy.
METHODS


Women with a BMI (in kg/m2) of ≥29 (n = 436) received counseling on healthy eating (HE), physical activity (PA), or both. The control group received usual care. This secondary analysis had a factorial design with comparison of HE compared with no HE and PA compared with no PA. Maternal outcomes at 24-28 wk were gestational weight gain (GWG), maternal fasting glucose, insulin, insulin resistance (HOMA-IR), disposition index, and development of GDM. Neonatal outcomes were cord blood leptin and C-peptide and estimated neonatal fat percentage. The interaction between receiving either the HE or PA intervention and genotypes of both rs10830962 and rs10830963 was assessed using multilevel regression analysis.
RESULTS


GDM risk was increased in women homozygous for the G allele of rs10830962 (OR: 2.60; 95% CI: 1.34, 5.06) or rs10830963 (OR: 2.83; 95% CI: 1.24, 6.47). Significant interactions between rs10830962 and interventions were found: in women homozygous for the G allele but not in the other genotypes, the PA intervention reduced maternal fasting insulin (β: -0.16; 95% CI: -0.33, 0.02; P = 0.08) and HOMA-IR (β: -0.17; 95% CI: -0.35, 0.01; P = 0.06), and reduced cord blood leptin (β: -0.84; 95% CI: -1.42, -0.25; P = 0.01) and C-peptide (β: -0.62; 95% CI: -1.07, -0.17; P = 0.01). In heterozygous women, the HE intervention had no effect, whereas in women homozygous for the C allele, HE intervention reduced GWG (β: -1.6 kg; 95% CI: -2.4, -0.8 kg). No interactions were found.
CONCLUSIONS


In women homozygous for the risk allele of MTNR1B rs10830962, GDM risk was increased and PA intervention might be more beneficial than HE intervention for reducing maternal insulin resistance, cord blood C-peptide, and cord blood leptin.",2022,"RESULTS


GDM risk was increased in women homozygous for the G allele of rs10830962 or rs10830963 (OR 2.60 [95% CI 1.34, 5.06] and 2.83 [1.24, 6.47], respectively).",['Women with a BMI of ≥29'],"['counseling on healthy eating (HE), physical activity (PA) or both', 'MTNR1B and lifestyle intervention', 'usual care', 'melatonin receptor 1B gene (MTNR1B) and lifestyle intervention', 'HE versus no HE and PA versus no PA']","['maternal insulin resistance, cord blood C-peptide and cord blood leptin', 'maternal fasting insulin', 'GDM risk', 'gestational weight gain (GWG), maternal fasting glucose, insulin, insulin resistance (HOMA-IR), disposition index, and development of GDM', 'reduced cord blood leptin', 'cord blood leptin and C-peptide and estimated neonatal fat percentage', 'GWG', 'HOMA-IR']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0065911', 'cui_str': 'Melatonin Receptors'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",,0.0658517,"RESULTS


GDM risk was increased in women homozygous for the G allele of rs10830962 or rs10830963 (OR 2.60 [95% CI 1.34, 5.06] and 2.83 [1.24, 6.47], respectively).","[{'ForeName': 'Mireille N M', 'Initials': 'MNM', 'LastName': 'van Poppel', 'Affiliation': 'Institute of Human Movement Science, Sport and Health, University of Graz, Graz, Austria.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Corcoy', 'Affiliation': 'Institut de Recerca de l´Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hill', 'Affiliation': 'Recherche en Santé Lawson SA, Bronschhofen, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simmons', 'Affiliation': 'Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Leire', 'Initials': 'L', 'LastName': 'Mendizabal', 'Affiliation': 'Patia Europe, San Sebastian, Spain.'}, {'ForeName': 'Mirella', 'Initials': 'M', 'LastName': 'Zulueta', 'Affiliation': 'Patia Europe, San Sebastian, Spain.'}, {'ForeName': 'Laureano', 'Initials': 'L', 'LastName': 'Simon', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Desoye', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University Graz, Graz, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab347']
1212,34670790,"Response to Comment on Rosenstock et al. Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial. Diabetes Care 2020;43:2509-2518.",,2021,,['Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy'],"['Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide']",[],"[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C2607479', 'cui_str': 'albiglutide'}]",[],,0.04862,,"[{'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center, Dallas, TX juliorosenstock@dallasdiabetes.com.'}]",Diabetes care,['10.2337/dci21-0004']
1213,34668065,"Topical application of Otosporin® before in-office bleaching: a split mouth, triple-blind, multicenter randomized clinical trial.","OBJECTIVES


To evaluate if the topical application of Otosporin® before in-office bleaching with a 35% hydrogen peroxide (HP) gel reduces the risk and intensity of tooth sensitivity (TS), as well as the bleaching effectiveness.
MATERIALS AND METHODS


Twenty participants were selected for this split mouth, triple-blind, multicenter randomized clinical trial. Before each bleaching session, the placebo was applied in the patient's hemi-arch and the other half received the Otosporin®, according to the randomization procedure. Both products were applied topically for 10 min. The 35% HP was applied in two sessions with a 1-week interval. The risk and intensity of TS were assessed using the Numerical Scale (NRS) and the Visual Analog Scale (VAS). The bleaching effectiveness were evaluated with the visual scales and with a digital spectrophotometer. The absolute risk of TS was compared by McNemar's test. To compare the intensity of TS, the Wilcoxon signed-rank test was used to evaluate the NRS, while the paired t test was used to evaluate VAS. Bleaching effectiveness (ΔSGUs and ΔE ab , ΔE 00 , and ΔWI D ) was compared between groups using the paired t-test (α = 0.05).
RESULTS


No significant difference at risk (p = 1.0) and intensity of TS (p > 0.59; VAS and p = 1.00 for NRS) was detected between groups. For both groups, a significant bleaching was observed after 30 days of evaluation (p < 0.39).
CONCLUSIONS


The previous application of Otosporin® in the in-office bleaching did not reduce the risk and intensity of TS and did not affect the effectiveness of the bleaching.
CLINICAL RELEVANCE


The application of Otosporin® before in-office bleaching with 35% HP was not able to reduce the risk and intensity of TS.",2022,"The previous application of Otosporin® in the in-office bleaching did not reduce the risk and intensity of TS and did not affect the effectiveness of the bleaching.
",['Twenty participants'],"['Otosporin®', 'hydrogen peroxide (HP) gel', 'placebo']","['risk and intensity of TS', 'risk and intensity of tooth sensitivity (TS', 'absolute risk of TS', 'Numerical Scale (NRS) and the Visual Analog Scale (VAS', 'intensity of TS', 'Bleaching effectiveness', 'bleaching effectiveness']",[],"[{'cui': 'C0134254', 'cui_str': 'Otosporin'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",20.0,0.0480849,"The previous application of Otosporin® in the in-office bleaching did not reduce the risk and intensity of TS and did not affect the effectiveness of the bleaching.
","[{'ForeName': 'Michael Willian', 'Initials': 'MW', 'LastName': 'Favoreto', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Rua Carlos Cavalcanti, 4748 Bloco M, Sala 64-A, Uvaranas, PR, Ponta Grossa, Brazil.'}, {'ForeName': 'Laína', 'Initials': 'L', 'LastName': 'Vochikovski', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Rua Carlos Cavalcanti, 4748 Bloco M, Sala 64-A, Uvaranas, PR, Ponta Grossa, Brazil.'}, {'ForeName': 'Renata Maria Oleniki', 'Initials': 'RMO', 'LastName': 'Terra', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Rua Carlos Cavalcanti, 4748 Bloco M, Sala 64-A, Uvaranas, PR, Ponta Grossa, Brazil.'}, {'ForeName': 'Veridiana Silva', 'Initials': 'VS', 'LastName': 'Campos', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Rua Carlos Cavalcanti, 4748 Bloco M, Sala 64-A, Uvaranas, PR, Ponta Grossa, Brazil.'}, {'ForeName': 'Mariana Evangelista', 'Initials': 'ME', 'LastName': 'Santos', 'Affiliation': 'Department of Operative Dentistry, Federal University of Paraiba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Sônia Saeger', 'Initials': 'SS', 'LastName': 'Meireles', 'Affiliation': 'Department of Operative Dentistry, Federal University of Paraiba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Rua Carlos Cavalcanti, 4748 Bloco M, Sala 64-A, Uvaranas, PR, Ponta Grossa, Brazil.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Rua Carlos Cavalcanti, 4748 Bloco M, Sala 64-A, Uvaranas, PR, Ponta Grossa, Brazil. aloguercio@hotmail.com.'}]",Clinical oral investigations,['10.1007/s00784-021-04224-9']
1214,34667294,"Mismatch negativity as an index of target engagement for excitation/inhibition-based treatment development: a double-blind, placebo-controlled, randomized, single-dose cross-over study of the serotonin type-3 receptor antagonist CVN058.","Serotonin type-3 receptor (5-HT 3 R) antagonists show potential as a treatment for cognitive deficits in schizophrenia. CVN058, a brain-penetrant, potent and selective 5-HT 3 R antagonist, shows efficacy in rodent models of cognition and was well-tolerated in Phase-1 studies. We evaluated the target engagement of CVN058 using mismatch negativity (MMN) in a randomized, double-blind, placebo-controlled, cross-over study. Subjects were stable outpatients with schizophrenia or schizoaffective disorder treated with antipsychotics. Subjects were not permitted to use other 5-HT 3 R modulators or serotonin reuptake inhibitors. Each subject received a high (150 mg) and low (15 mg or 75 mg) oral dose of CVN058 and placebo in a randomized order across 3 single-day treatment visits separated by at least 1 week. The primary pre-registered outcome was amplitude of duration MMN. Amplitude of other MMN deviants (frequency, intensity, frequency modulation, and location), P50, P300 and auditory steady-state response (ASSR) were exploratory endpoints. 19 of 22 randomized subjects (86.4%) completed the study. Baseline PANSS scores indicated moderate impairment. CVN058 150 mg led to significant improvement vs. placebo on the primary outcome of duration MMN (p = 0.02, Cohen's d = 0.48). A significant treatment effect was also seen in a combined analysis across all MMN deviants (p < 0.001, d = 0.57). Effects on location MMN were independently significant (p < 0.007, d = 0.46). No other significant effects were seen for other deviants, doses or EEG measures. There were no clinically significant treatment related adverse effects. These results show MMN to be a sensitive target engagement biomarker for 5-HT 3 R, and support the potential utility of CVN058 in correcting the excitatory/inhibitory imbalance in schizophrenia.",2022,"A significant treatment effect was also seen in a combined analysis across all MMN deviants (p < 0.001, d = 0.57).","['Subjects were stable outpatients with schizophrenia or schizoaffective disorder treated with', '19 of 22 randomized subjects (86.4%) completed the study']","['antipsychotics', 'Serotonin type-3 receptor (5-HT 3 R) antagonists', 'CVN058 using mismatch negativity (MMN', '5-HT 3 R modulators or serotonin reuptake inhibitors', 'CVN058', 'CVN058 and placebo', 'placebo']","['Amplitude of other MMN deviants (frequency, intensity, frequency modulation, and location), P50, P300 and auditory steady-state response (ASSR', 'location MMN', 'duration MMN', 'amplitude of duration MMN', 'adverse effects']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1700654', 'cui_str': 'HTR3A protein, human'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0162758', 'cui_str': 'Serotonin uptake inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0219874', 'cui_str': 'p50(csk)'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.077677,"A significant treatment effect was also seen in a combined analysis across all MMN deviants (p < 0.001, d = 0.57).","[{'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Sehatpour', 'Affiliation': 'Department of Psychiatry, Columbia University, College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'Department of Psychiatry, Columbia University, College of Physicians and Surgeons, New York, NY, USA. dcj2113@cumc.columbia.edu.'}, {'ForeName': 'Heloise M', 'Initials': 'HM', 'LastName': 'De Baun', 'Affiliation': 'Department of Psychiatry, Columbia University, College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Carlson', 'Affiliation': 'Department of Psychiatry, Columbia University, College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Beloborodova', 'Affiliation': 'Department of Psychiatry, Columbia University, College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Margolin', 'Affiliation': 'Cerevance, Inc, Boston, MA, USA.'}, {'ForeName': 'Mark B L', 'Initials': 'MBL', 'LastName': 'Carlton', 'Affiliation': 'Cerevance Ltd., Cambridge, UK.'}, {'ForeName': 'Nicola L', 'Initials': 'NL', 'LastName': 'Brice', 'Affiliation': 'Cerevance Ltd., Cambridge, UK.'}, {'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'Department of Psychiatry, Columbia University, College of Physicians and Surgeons, New York, NY, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-01170-8']
1215,34747584,A Pavlovian Intervention to Condition Comforting Effects of Fruits.,"OBJECTIVE


Perceived stress, lower fruit intake, and comfort eating are all risk factors for chronic disease. The present pilot study aimed to simultaneously mitigate all three risk factors by applying Pavlovian conditioning to change the nature of comfort eating. Specifically, stressed participants underwent a Pavlovian conditioning intervention designed to elicit comforting effects of fruit intake and thereby reduce negative mood while promoting fruit intake.
METHODS


We developed a seven-dose Pavlovian conditioning intervention wherein participants temporally paired together Progressive Muscle Relaxation (unconditioned stimulus) with fruit intake (conditioned stimulus) daily for 1 week. Participants (N = 100, mean [standard deviation] age = 20.7 [4.6] years; 74% female) with moderate to high levels of baseline perceived stress were randomized to the intervention or an active explicitly unpaired control group, wherein the Progressive Muscle Relaxation and fruit intake also occurred but were not temporally paired together. After the intervention, participants' negative mood was assessed immediately before and after fruit intake to assess conditioning effects. Then, participants logged their regular food intake for 4 days using the MyFitnessPal smartphone app.
RESULTS


After the intervention, fruit intake acutely improved negative mood to a greater extent among the intervention versus control group (F(1,98) = 3.99, p = .048, = 0.039). However, there was not a significant between-group difference in intake of fruit or traditional comfort foods at postintervention.
CONCLUSIONS


Repeated pairing of fruit intake with a reliable distress-reducing activity led to the conditioning of comforting effects of fruit intake. Further refinement of the intervention design is necessary to translate this conditioned association to actual intake of fruit and other foods.",2021,"After the intervention, fruit intake acutely improved negative mood to a greater extent among the intervention versus control group (F(1,98) = 3.99, p = .048, = 0.039).","['Participants (N = 100, mean [standard deviation] age = 20.7 [4.6] years; 74% female) with moderate to high levels of baseline perceived stress']","['Fruits', 'Pavlovian conditioning intervention', 'Pavlovian conditioning intervention wherein participants temporally paired together Progressive Muscle Relaxation (unconditioned stimulus) with fruit intake (conditioned stimulus) daily for 1 week']","['intake of fruit or traditional comfort foods', 'negative mood']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0009649', 'cui_str': 'Conditioning, Classical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0234403', 'cui_str': 'Unconditioned stimulus'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",100.0,0.0173581,"After the intervention, fruit intake acutely improved negative mood to a greater extent among the intervention versus control group (F(1,98) = 3.99, p = .048, = 0.039).","[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Finch', 'Affiliation': 'From the Academic Research Centers (Finch), NORC at the University of Chicago, Chicago, Illinois; Social and Behavioral Sciences Branch, Division of Intramural Population Health Research (Cummings), Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Maryland; and Department of Psychology (Lee, Tomiyama), University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Cummings', 'Affiliation': ''}, {'ForeName': 'Sophie C', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'A Janet', 'Initials': 'AJ', 'LastName': 'Tomiyama', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000001008']
1216,34747583,β-Adrenergic Contributions to Emotion and Physiology During an Acute Psychosocial Stressor.,"OBJECTIVE


β-Adrenergic receptor signaling, a critical mediator of sympathetic nervous system influences on physiology and behavior, has long been proposed as one contributor to subjective stress. However, prior findings are surprisingly mixed about whether β-blockade (e.g., propranolol) blunts subjective stress, with many studies reporting no effects. We reevaluated this question in the context of an acute psychosocial stressor with more comprehensive measures and a larger-than-typical sample. We also examined the effects of β-blockade on psychophysiological indicators of sympathetic and parasympathetic nervous system reactivity, given that β-blockade effects for these measures specifically under acute psychosocial stress are not yet well established.
METHODS


In a double-blind, randomized, placebo-controlled study, 90 healthy young adults received 40 mg of the β-blocker propranolol or placebo. Participants then completed the Trier Social Stress Test, which involved completing an impromptu speech and difficult arithmetic in front of evaluative judges. Self-reported emotions and appraisals as well as psychophysiology were assessed throughout.
RESULTS


Propranolol blunted Trier Social Stress Test preejection period reactivity (b = 9.68, p = .003), a marker of sympathetic nervous system activity, as well as salivary α-amylase reactivity (b = -0.50, p = .006). Critically, propranolol also blunted negative, high arousal emotions in response to the stressor (b = -0.22, p = .026), but cognitive appraisals remained intact (b values < -0.17, p values > .10).
CONCLUSIONS


These results provide updated experimental evidence that β-adrenergic blockade attenuates negative, high arousal emotions in response to a psychosocial stressor while also blunting sympathetic nervous system reactivity. Together, these findings shed light on the neurophysiological mechanisms by which stressors transform into the subjective experience we call ""stress.""Trial Registration: ClinicalTrials.gov Identifier: NCT02972554.",2021,"RESULTS


Propranolol blunted Trier Social Stress Test preejection period reactivity (b = 9.68, p = .003), a marker of sympathetic nervous system activity, as well as salivary α-amylase reactivity (b = -0.50, p = .006).",['90 healthy young adults received 40 mg of the'],"['propranolol', 'β-blockade', 'β-blocker propranolol or placebo', 'placebo', 'Propranolol']","['blunted negative, high arousal emotions', 'marker of sympathetic nervous system activity', 'salivary α-amylase reactivity', 'blunted Trier Social Stress Test preejection period reactivity']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]",90.0,0.100634,"RESULTS


Propranolol blunted Trier Social Stress Test preejection period reactivity (b = 9.68, p = .003), a marker of sympathetic nervous system activity, as well as salivary α-amylase reactivity (b = -0.50, p = .006).","[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'MacCormack', 'Affiliation': 'From the Department of Psychology and Neuroscience (MacCormack, Gaudier-Diaz, Lindquist, Muscatell), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Department of Psychiatry (MacCormack), University of Pittsburgh, Pittsburgh, Pennsylvania; Graduate School of Education (Armstrong-Carter), Stanford University, Stanford, California; Department of Psychiatry (Meltzer-Brody), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Monash Institute of Pharmaceutical Sciences, Drug Discovery Biology Theme (Sloan), Monash University, Parkville; Division of Surgery (Sloan), Peter MacCallum Cancer Center, Melbourne, Victoria, Australia; Lineberger Comprehensive Cancer Center (Muscatell) and Carolina Population Center (Muscatell), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Armstrong-Carter', 'Affiliation': ''}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Gaudier-Diaz', 'Affiliation': ''}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Meltzer-Brody', 'Affiliation': ''}, {'ForeName': 'Erica K', 'Initials': 'EK', 'LastName': 'Sloan', 'Affiliation': ''}, {'ForeName': 'Kristen A', 'Initials': 'KA', 'LastName': 'Lindquist', 'Affiliation': ''}, {'ForeName': 'Keely A', 'Initials': 'KA', 'LastName': 'Muscatell', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000001009']
1217,34747567,Long-term efficacy and complications of a multicentre randomised controlled trial comparing Retropubic and Transobturator Mid-Urethral Slings: a prospective observational study.,,2022,,[],['Retropubic and Transobturator Mid-Urethral Slings'],[],[],"[{'cui': 'C0205499', 'cui_str': 'Retropubic approach'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}]",[],,0.090111,,"[{'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Agur', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16982']
1218,34743540,Blood Pressure and Safety Events With Vericiguat in the VICTORIA Trial.,"Background Although safety and tolerability of vericiguat were established in the VICTORIA (Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction) trial in patients with heart failure with reduced ejection fraction, some subgroups may be more susceptible to symptomatic hypotension, such as older patients, those with lower baseline systolic blood pressure (SBP), or those concurrently taking angiotensin receptor neprilysin inhibitors. We described the SBP trajectories over time and compared the occurrence of symptomatic hypotension or syncope by treatment arm in potentially vulnerable subgroups in VICTORIA. We also evaluated the relation between the efficacy of vericiguat and baseline SBP. Methods and Results Among patients receiving at least 1 dose of the study drug (n=5034), potentially vulnerable subgroups were those >75 years old (n=1395), those with baseline SBP 100-110 mm Hg (n=1344), and those taking angiotensin receptor neprilysin inhibitors (n=730). SBP trajectory was plotted as mean change from baseline over time. The treatment effect on time to symptomatic hypotension or syncope was evaluated overall and by subgroup, and the primary efficacy composite outcome (heart failure hospitalization or cardiovascular death) across baseline SBP was examined using Cox proportional hazards models. SBP trajectories showed a small initial decline in SBP with vericiguat in those >75 years old (versus younger patients), as well as those receiving angiotensin receptor neprilysin inhibitors (versus none), with SBP returning to baseline thereafter. Patients with SBP <110 mm Hg at baseline showed a trend to increasing SBP over time, which was similar in both treatment arms. Safety event rates were generally low and similar between treatment arms within each subgroup. In Cox proportional hazards analysis, there were similar numbers of safety events with vericiguat versus placebo (adjusted hazard ratio [HR], 1.18; 95% CI, 0.99-1.39;  P =0.059). No difference existed between treatment arms in landmark analysis beginning after the titration phase (ie, post 4 weeks) (adjusted HR, 1.14; 95% CI, 0.93-1.38;  P =0.20). The benefit of vericiguat compared with placebo on the primary composite efficacy outcome was similar across the spectrum of baseline SBP ( P  for interaction=0.32). Conclusions These data demonstrate the safety of vericiguat in a broad population of patients with worsening heart failure with reduced ejection fraction, even among those predisposed to hypotension. Vericiguat's efficacy persisted regardless of baseline SBP. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02861534.",2021,"No difference existed between treatment arms in landmark analysis beginning after the titration phase (ie, post 4 weeks)","['patients receiving at least 1 dose of the study drug (n=5034), potentially vulnerable subgroups were those >75\xa0years old (n=1395), those with baseline SBP 100-110\xa0mm\xa0Hg (n=1344), and those taking angiotensin receptor neprilysin inhibitors (n=730', 'Patients with SBP', '110\xa0mm', 'Subjects With Heart Failure With Reduced Ejection Fraction) trial in patients with heart failure with reduced ejection fraction']",['placebo'],"['time to symptomatic hypotension or syncope', 'baseline systolic blood pressure (SBP', 'SBP trajectory', 'SBP', 'primary efficacy composite outcome (heart failure hospitalization or cardiovascular death', 'Safety event rates', 'Blood Pressure and Safety Events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.372245,"No difference existed between treatment arms in landmark analysis beginning after the titration phase (ie, post 4 weeks)","[{'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore & Duke-National University of Singapore Singapore.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research InstituteDuke University School of Medicine Durham NC.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Lopatin', 'Affiliation': 'Volgograd State Medical UniversityRegional Cardiology Centre Volgograd Volgograd Russian Federation.'}, {'ForeName': 'Jose B', 'Initials': 'JB', 'LastName': 'Vazquez-Tanus', 'Affiliation': 'Ponce School of Medicine Ponce Puerto Rico.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Siu', 'Affiliation': 'Li Ka Shing Faculty of Medicine The University of Hong Kong Hong Kong.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre University of Alberta Edmonton Canada.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Charité University MedicineGerman Heart Center Berlin Germany.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute Falls Church VA.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Bayer AG Wuppertal Germany.'}, {'ForeName': 'Mahesh J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'Merck & Co. Inc. Kenilworth NJ.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research InstituteDuke University School of Medicine Durham NC.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research InstituteDuke University School of Medicine Durham NC.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Canadian VIGOUR Centre University of Alberta Edmonton Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.121.021094']
1219,34748679,A virtual reality system for pain and anxiety management during outpatient hysteroscopy-A randomized control trial.,"BACKGROUND


Visual and acoustic virtual reality (VR) has been increasingly explored as a non-pharmacological tool for pain relief in clinical settings.
OBJECTIVE


We aimed to evaluate the effectiveness of VR as a distraction technique in the management of acute pain during operative hysteroscopy in the outpatient setting.
METHODS


A prospective, open-label, randomized control trial in a tertiary university-affiliated medical centre between April and August 2020. Overall, 82 women were randomly allocated to undergo operative hysteroscopy either with the use of VR (n = 44, study group) or with standard treatment (control group, n = 38). VR was applied throughout the procedure and no anaesthesia was given. The primary outcome measures included self-reported intraoperative pain. Other objectives included vital parameters as pulse rate (PR) and respiratory rate (RR) before and during the first 3 min of the procedure. Pain and anxiety outcomes were measured as numeric rating scores.
RESULTS


The baseline parameters were similar between groups. The mean duration for the procedure was 8.1 ± 3.2 vs. 7.3 ± 6.0 min for the study and the control groups (p = 0.23). There were no statistically significant differences between the reported pain scores during the procedure [median (interquartile range) 5.0 (3.0-7.2) vs. 5.0 (3.0-8.0), respectively; p = 0.67]. While neither intraoperative heart rate nor respiratory rate differed between groups [14.0 (13.0-16.0) vs. 14.0 (11.0-16.5); p = 0.77)], the increase of heart rate was found greater in the VR group [+7.0 (8.5) vs. +1.0 (12.2); p = 0.01].
CONCLUSION


VR was not effective in reducing pain during an outpatient operative hysteroscopy.
SIGNIFICANCE


The use of a Virtual reality system was found ineffective in reducing pain during and after an office operative hysteroscopy without anaesthesia, in a thorough examination of both continuous physiological parameters and women's self-reported measures.",2022,"While neither intraoperative heart rate nor respiratory rate differed between groups [14.0 (13.0-16.0) vs 14.0 (11.0-16.5); P = .77)], the increase of heart rate was found greater in the VR group [+7.0 (8.5) vs. +1.0 (12.2); P = .01].
","['tertiary university-affiliated medical center between April to August 2020', '82 women']","['Visual and acoustic virtual reality (VR', 'operative hysteroscopy either with the use of VR', 'VR']","['mean duration for the procedure', 'pain', 'pulse rate (PR) and respiratory rate (RR', 'heart rate', 'self-reported intraoperative pain', 'numeric rating scores', 'pain scores', 'Pain and anxiety outcomes', 'intraoperative heart rate nor respiratory rate']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",82.0,0.0383238,"While neither intraoperative heart rate nor respiratory rate differed between groups [14.0 (13.0-16.0) vs 14.0 (11.0-16.5); P = .77)], the increase of heart rate was found greater in the VR group [+7.0 (8.5) vs. +1.0 (12.2); P = .01].
","[{'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Fouks', 'Affiliation': 'Lis Hospital for Women, Affiliated with the Sackler Faculty of Medicine, Department of Obstetrics and Gynecology, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Kern', 'Affiliation': 'Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Aviad', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Lis Hospital for Women, Affiliated with the Sackler Faculty of Medicine, Department of Obstetrics and Gynecology, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Reicher', 'Affiliation': 'Lis Hospital for Women, Affiliated with the Sackler Faculty of Medicine, Department of Obstetrics and Gynecology, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Shapira', 'Affiliation': 'Lis Hospital for Women, Affiliated with the Sackler Faculty of Medicine, Department of Obstetrics and Gynecology, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Many', 'Affiliation': 'Lis Hospital for Women, Affiliated with the Sackler Faculty of Medicine, Department of Obstetrics and Gynecology, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Yariv', 'Initials': 'Y', 'LastName': 'Yogev', 'Affiliation': 'Lis Hospital for Women, Affiliated with the Sackler Faculty of Medicine, Department of Obstetrics and Gynecology, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Gilad', 'Initials': 'G', 'LastName': 'Rattan', 'Affiliation': 'Lis Hospital for Women, Affiliated with the Sackler Faculty of Medicine, Department of Obstetrics and Gynecology, Tel-Aviv University, Tel-Aviv, Israel.'}]","European journal of pain (London, England)",['10.1002/ejp.1882']
1220,34749782,Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): study protocol for a randomized non-inferiority trial of magnetic seizure therapy versus electroconvulsive therapy.,"BACKGROUND


Electroconvulsive therapy (ECT) is well-established and effective for treatment-resistant depression (TRD), but in Canada and the USA, less than 1% of patients with TRD receive ECT mainly due to its cognitive adverse effects (i.e. amnesia). Thus, new treatment alternatives for TRD are urgently needed. One such treatment is magnetic seizure therapy (MST). ECT involves applying a train of high-frequency electrical stimuli to induce a seizure, whereas MST involves applying a train of high-frequency magnetic stimuli to induce a seizure.
METHODS


In this manuscript, we introduce our international, two-site, double-blinded, randomized, non-inferiority clinical trial to develop MST as an effective and safe treatment for TRD. This trial will compare the efficacy of MST to right unilateral ultra-brief pulse width electroconvulsive therapy (RUL-UB-ECT) with a combined primary endpoint of remission of depression and superior cognitive adverse effects in 260 patients with TRD. Amelioration of suicidal ideation will be assessed as a secondary endpoint. Inpatients or outpatients, over 18 years of age with a MINI International Neuropsychiatric Interview (MINI) diagnosis of non-psychotic major depressive disorder (MDD) can be enrolled in the study provided that they meet illness severity and full eligibility criteria. Participants are randomized to receive MST or RUL-UB ECT, 2-3 days per week over seven weeks, or a maximum of 21 treatments. The study will involve before-, during-, and after-treatment assessments of depression severity, suicidal ideation, subjective side-effects, and cognitive performance consistent with an intent-to-treat study design approach.
DISCUSSION


Positive results from this trial could have an immediate and tremendous impact for patients with TRD. If MST demonstrates comparable antidepressant treatment efficacy to ECT, but with greater cognitive safety, it could rapidly be adopted into clinical practice. Indeed, given that the administration of MST is nearly identical to ECT, the majority of ECT facilities in North America could readily adopt MST. Furthermore, the potential for cognitive safety could lead to improved treatment acceptability. Healthcare providers, patients and care partners, and policymakers would therefore demand this form of convulsive therapy.
TRIAL STATUS


Enrollment for this study began on June 26, 2018, and is estimated to complete recruitment by July 2024. At the time of submission, we have enrolled and randomized 117 participants.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03191058 , Registered on June 19, 2017. Primary sponsor: Daniel Blumberger (DMB), Principal Investigator Daniel.Blumberger@camh.ca , 416-535-8501 x 33662 Contact for public queries: DMB, Daniel.Blumberger@camh.ca Contact for scientific queries: ZJD, Zdaskalakis@health.ucsd.edu.",2021,"If MST demonstrates comparable antidepressant treatment efficacy to ECT, but with greater cognitive safety, it could rapidly be adopted into clinical practice.","['260 patients with TRD', 'patients with TRD', 'Enrollment for this study began on June 26, 2018, and is estimated to complete recruitment by July 2024', 'Depression', 'Inpatients or outpatients, over 18\u2009years of age with a MINI International Neuropsychiatric Interview (MINI) diagnosis of non-psychotic major depressive disorder (MDD']","['MST', 'Magnetic Seizure Therapy', 'Electroconvulsive therapy (ECT', 'magnetic seizure therapy', 'MST to right unilateral ultra-brief pulse width electroconvulsive therapy (RUL-UB-ECT', 'MST or RUL-UB ECT', 'CREST-MST', 'electroconvulsive therapy', 'ECT', 'magnetic seizure therapy (MST']","['remission of depression and superior cognitive adverse effects', 'cognitive safety', 'depression severity, suicidal ideation, subjective side-effects, and cognitive performance', 'suicidal ideation']","[{'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0444804', 'cui_str': 'Brief pulse'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C1261074', 'cui_str': 'Structure of upper lobe of right lung'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",117.0,0.247464,"If MST demonstrates comparable antidepressant treatment efficacy to ECT, but with greater cognitive safety, it could rapidly be adopted into clinical practice.","[{'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, USA. zdaskalakis@health.ucsd.edu.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Tamminga', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Alanah', 'Initials': 'A', 'LastName': 'Throop', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Palmer', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dimitrova', 'Affiliation': 'Department of Psychology, University at Buffalo, The State University of New York | SUNY Buffalo, Buffalo, USA.'}, {'ForeName': 'Faranak', 'Initials': 'F', 'LastName': 'Farzan', 'Affiliation': 'School of Mechatronic Systems Engineering, Simon Fraser University, Surrey, British Columbia, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's, Toronto, Ontario, Canada.""}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Institute of Medical Science and Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}]",Trials,['10.1186/s13063-021-05730-7']
1221,34751818,Teaching medical students to choose wisely through simulation.,"The Choosing Wisely (CW) campaign aims to encourage dialog among physicians and patients about the costs and benefits of medical care. The purpose of the present study was to describe the implementation of the CW campaign among medical students in the pediatrics clerkship using different teaching strategies and to evaluate the students' perception and performance. A prospective, interventionist, open study with a control group was conducted. All sixth-year undergraduate medical students that were on their pediatric clerkship at the Emergency Department during the study period were invited to participate. The study consisted of two strategies: a remote video class about the CW initiative and in situ simulation training. By the end of the rotation, all participants were evaluated through an Objective Structured Clinical Examination (OSCE). A total of 50 students were included, of which 24 watched only the online video (control group) and 26 were exposed to both the online video and the simulation scenarios (intervention group). Students in the intervention group had a significantly higher total score in the OSCE compared to students in the control group (median 90 vs 90; range 78-100 vs 50-100; p: 0.047). Median scores of behavioral items of the OSCE grouped together were significantly higher in the intervention group compared to the control group (median 60 vs 50; range 40-60 vs 20-60; p: 0.002).Conclusion: Simulation training about principles of the CW campaign had a greater impact on behavioral aspects of undergraduate students. This learning strategy was well accepted by participants. What is Known: • The Choosing Wisely (CW) campaign aims to encourage dialog among physicians and patients about the costs and benefits of medical care. • Teaching high-value and cost-conscious care to medical students is highly desired.. What is New: • Simulation training about principles of the CW campaign had a greater impact on behavioral aspects of undergraduate students.",2022,Median scores of behavioral items of the OSCE grouped together were significantly higher in the intervention group compared to the control group (median 60 vs 50; range 40-60 vs 20-60; p: 0.002).Conclusion: Simulation training about principles of the CW campaign had a greater impact on behavioral aspects of undergraduate students.,"['undergraduate students', 'medical students', 'All sixth-year undergraduate medical students that were on their pediatric clerkship at the Emergency Department during the study period were invited to participate', 'A total of 50 students were included, of which 24 watched only the online video (control group) and 26 were exposed to both the online video and the simulation scenarios (intervention group']","['CW campaign', 'remote video class about the CW initiative and in situ simulation training']","['Objective Structured Clinical Examination (OSCE', 'Median scores of behavioral items', 'OSCE', 'total score']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",50.0,0.0121705,Median scores of behavioral items of the OSCE grouped together were significantly higher in the intervention group compared to the control group (median 60 vs 50; range 40-60 vs 20-60; p: 0.002).Conclusion: Simulation training about principles of the CW campaign had a greater impact on behavioral aspects of undergraduate students.,"[{'ForeName': 'Thayza Marcelly Rodrigues', 'Initials': 'TMR', 'LastName': 'Morato', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil.'}, {'ForeName': 'Pedro Henrique Magalhães', 'Initials': 'PHM', 'LastName': 'Mendes', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil.'}, {'ForeName': 'Danielle Saad Nemer Bou', 'Initials': 'DSNB', 'LastName': 'Ghosn', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil.'}, {'ForeName': 'Thomaz Bittencourt', 'Initials': 'TB', 'LastName': 'Couto', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil.'}, {'ForeName': 'Paulo Victor Ferreira', 'Initials': 'PVF', 'LastName': 'Mai', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil.'}, {'ForeName': 'Sylvia Costa Lima', 'Initials': 'SCL', 'LastName': 'Farhat', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil.'}, {'ForeName': 'Cláudio', 'Initials': 'C', 'LastName': 'Schvartsman', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil.'}, {'ForeName': 'Nara Vasconcelos', 'Initials': 'NV', 'LastName': 'Cavalcanti', 'Affiliation': 'Instituto da Criança do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Av Dr Enéas Carvalho de Aguiar, 647, São Paulo (SP), 05403-901, Brazil. cavalcantinara@gmail.com.'}]",European journal of pediatrics,['10.1007/s00431-021-04305-7']
1222,34751780,What Factors are Associated With Waterpipe Smoking Cessation? A Secondary Data Analysis.,"INTRODUCTION


Waterpipe smoking is gaining popularity and becoming a major global public health concern. An understanding of factors that predict waterpipe smoking cessation is necessary for targeting tobacco control efforts.
METHODS


This is a secondary data analysis of a randomized controlled trial comparing the efficacy of varenicline against placebo in helping waterpipe smokers to quit. A total of 510 adult daily waterpipe smokers were recruited to the trial in 2016. Logistic regression models were applied to assess factors (i.e., demographic, environmental, behavioral, and physiological) associated with primary outcome (waterpipe smoking cessation) and secondary outcomes (waterpipe cessation alongside abstinence from cigarette and short-term and long-term waterpipe smoking cessation). Cessation was defined as 7-day point prevalence abstinence from smoking reported at 5,12, and/or 25 weeks follow-ups.
RESULTS


Over a period of six months, 189 (39.2%) participants abstained from waterpipe smoking for at least one week. Being male (adjusted odds ratio (aOR):2.99 (95%CI:1.47-6.08)), dual smoker (waterpipe and cigarettes) (aOR:2.98 (95%CI:1.87-4.74)), more withdrawal symptoms measured by the Mood and Physical Symptoms Scale (aOR:1.08 (95%CI:1.02-1.13)), less nicotine dependency measured by Lebanon Waterpipe Dependency Scale (aOR:0.90 (95%CI:0.85-0.96)), having a history of quit attempt (aOR:2.14 (95%CI:1.16-3.96)), smoking restriction in the house (aOR:2.69 (95%CI:1.01-7.14)), and not sharing waterpipe with others (aOR:2.72 (95%CI:1.31-5.66)) predicted waterpipe smoking cessation.
CONCLUSIONS


In addition to nicotine dependency, social factors such as home restrictions on smoking, and not sharing waterpipe were identified as predictors of waterpipe smoking cessation. To help waterpipe smokers quit, social environment may be just as or even more important than well-known physical and psychological factors.
IMPLICATIONS


A range of factors, predominantly social factors play a significant role in facilitating or deterring waterpipe smokers from quitting smoking. Our findings suggest that interventions that focus on social as well as physical/psychological factors may encourage waterpipe smokers in achieving abstinence.",2022,"more withdrawal symptoms measured by the Mood and Physical Symptoms Scale (aOR:1.08 (95%CI:1.02-1.13)), less nicotine dependency measured by Lebanon Waterpipe Dependency Scale (aOR:0.90 (95%CI:0.85-0.96)), having history of quit attempt (aOR:2.14 (95%CI:1.16-3.96)), smoking restriction in the house (aOR:2.69 (95%CI:1.01-7.14)), and not sharing waterpipe with others (aOR:2.72 (95%CI:1.31-5.66)) predicted waterpipe smoking cessation.
","['helping waterpipe smokers to quit', '510 adult daily waterpipe smokers']",['varenicline against placebo'],"['Mood and Physical Symptoms Scale', 'smoking restriction', 'withdrawal symptoms', 'waterpipe smoking cessation', 'demographic, environmental, behavioural, and physiological) associated with primary outcome (waterpipe smoking cessation) and secondary outcomes (waterpipe cessation alongside abstinence from cigarette and short-term and long-term waterpipe smoking cessation', 'having history of quit attempt', 'nicotine dependency measured by Lebanon Waterpipe Dependency Scale']","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C4302493', 'cui_str': 'Hookah pipe'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C4505138', 'cui_str': 'Waterpipe Smoking'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C4302493', 'cui_str': 'Hookah pipe'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}]",510.0,0.0776858,"more withdrawal symptoms measured by the Mood and Physical Symptoms Scale (aOR:1.08 (95%CI:1.02-1.13)), less nicotine dependency measured by Lebanon Waterpipe Dependency Scale (aOR:0.90 (95%CI:0.85-0.96)), having history of quit attempt (aOR:2.14 (95%CI:1.16-3.96)), smoking restriction in the house (aOR:2.69 (95%CI:1.01-7.14)), and not sharing waterpipe with others (aOR:2.72 (95%CI:1.31-5.66)) predicted waterpipe smoking cessation.
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Shtaiwi', 'Affiliation': 'Freelance Research Consultant, Amman, Jordan.'}, {'ForeName': 'Faraz', 'Initials': 'F', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Kanaan', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Siddiqi', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab234']
1223,34758807,Implications of remote monitoring Technology in Optimizing Traditional Self-Monitoring of blood glucose in adults with T2DM in primary care.,"BACKGROUND


Self-monitoring of blood glucose (SMBG) has been shown to reduce hemoglobin A1C (HbA1C). Accordingly, guidelines recommend SMBG up to 4-10 times daily for adults with type 2 diabetes (T2DM) on insulin. For persons not on insulin, recommendations are equivocal. Newer technology-enabled blood glucose monitoring (BGM) devices can facilitate remote monitoring of glycemic data. New evidence generated by remote BGM may help to guide best practices for frequency and timing of finger-stick blood glucose (FSBG) monitoring in uncontrolled T2DM patients managed in primary care settings. This study aims to evaluate the impact of SMBG utility and frequency on glycemic outcomes using a novel BGM system which auto-transfers near real-time FSBG data to a cloud-based dashboard using cellular networks.
METHODS


Secondary analysis of the intervention arm of a comparative non-randomized trial with propensity-matched chart controls. Adults with T2DM and HbA1C > 9% receiving care in five primary care practices in a healthcare system participated in a 3-month diabetes boot camp (DBC) using telemedicine and a novel BGM to support comprehensive diabetes care management. The primary independent variable was frequency of FSBG. Secondary outcomes included frequency of FSBG by insulin status, distribution of FSBG checks by time of day, and hypoglycemia rates.
RESULTS


48,111 FSBGs were transmitted by 359 DBC completers. Participants performed 1.5 FSBG checks/day; with 1.6 checks/day for those on basal/bolus insulin. Higher FSBG frequency was associated with greater improvement in HbA1C independent of insulin treatment status (p = 0.0003). FSBG frequency was higher in patients treated with insulin (p = 0.003). FSBG checks were most common pre-breakfast and post-dinner. Hypoglycemia was rare (1.2% < 70 mg/dL).
CONCLUSIONS


Adults with uncontrolled T2DM achieved significant HbA1C improvement performing just 1.5 FSBGs daily during a technology-enabled diabetes care intervention. Among the 40% taking insulin, this improvement was achieved with a lower FSBG frequency than guidelines recommend. For those not on insulin, despite a lower frequency of FSBG, they achieved a greater reduction in A1C compared to patients on insulin. Low frequency FSBG monitoring pre-breakfast and post-dinner can potentially support optimization of glycemic control regardless of insulin status in the primary care setting.
TRIAL REGISTRATION


Trial registration number: NCT02925312 (10/19/2016).",2021,"For those not on insulin, despite a lower frequency of FSBG, they achieved a greater reduction in A1C compared to patients on insulin.","['Adults with T2DM and HbA1C >\u20099% receiving care in five primary care practices in a healthcare system participated in a 3-month diabetes boot camp (DBC) using', 'adults with type 2 diabetes (T2DM) on insulin', 'adults with T2DM in primary care']","['blood glucose (SMBG', 'Newer technology-enabled blood glucose monitoring (BGM) devices', 'telemedicine and a novel BGM to support comprehensive diabetes care management']","['frequency of FSBG by insulin status, distribution of FSBG checks by time of day, and hypoglycemia rates', 'FSBG checks', 'hemoglobin A1C (HbA1C', 'Higher FSBG frequency', 'Hypoglycemia', 'frequency of FSBG', 'FSBG frequency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0457575', 'cui_str': 'Finger stick'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0439548', 'cui_str': 'Temporal periods of day'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205250', 'cui_str': 'High'}]",48111.0,0.0415752,"For those not on insulin, despite a lower frequency of FSBG, they achieved a greater reduction in A1C compared to patients on insulin.","[{'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Montero', 'Affiliation': 'Department of Medicine, MedStar Georgetown University Hospital, 3800 Reservoir Rd, Washington, DC, 20007, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Toro-Tobon', 'Affiliation': 'Mayo Clinic, Division of Endocrinology, 200 1st Street NW, Rochester, MN, 55905, USA. Torotobon.david@mayo.edu.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Gann', 'Affiliation': 'BioTelemetry, 1000 Cedar Hollow Road, Suite 102, Malvern, PA, 19355, USA.'}, {'ForeName': 'Carine M', 'Initials': 'CM', 'LastName': 'Nassar', 'Affiliation': 'MedStar Diabetes Institute, 100 Irving Street, NW # 4114, Washington, DC, 20010, USA.'}, {'ForeName': 'Gretchen A', 'Initials': 'GA', 'LastName': 'Youssef', 'Affiliation': 'MedStar Diabetes Institute, 100 Irving Street, NW # 4114, Washington, DC, 20010, USA.'}, {'ForeName': 'Michelle F', 'Initials': 'MF', 'LastName': 'Magee', 'Affiliation': 'MedStar Diabetes Institute, 100 Irving Street, NW # 4114, Washington, DC, 20010, USA.'}]",BMC endocrine disorders,['10.1186/s12902-021-00884-6']
1224,34761694,"Peripheral nerve stimulation for the management of acute and subacute post-amputation pain: a randomized, controlled feasibility trial.","Introduction & aim:  Temporary (60-day) percutaneous peripheral nerve stimulation (PNS) has demonstrated effectiveness for the treatment of chronic post-amputation pain, and this pilot study aims to evaluate the feasibility of temporary percutaneous PNS for the treatment of acute post-amputation pain.  Patients & methods:  Sixteen veterans undergoing lower extremity amputation received PNS and standard medical therapy or standard medical therapy alone.  Results:  The PNS group reported greater reductions in average phantom limb pain, residual limb pain and daily opioid consumption, and there were fewer participants taking opioids through 3 months post-amputation.  Conclusion:  This pilot study suggests that PNS is feasible in the acute postoperative period following lower limb amputation and may provide a non-pharmacologic analgesic therapy that lowers pain scores and reduces opioid consumption, and thus warrants further investigation.",2022,"The PNS group reported greater reductions in average phantom limb pain, residual limb pain and daily opioid consumption, and there were fewer participants taking opioids through 3 months post-amputation.  ","['acute and subacute post-amputation pain', 'Patients & methods:  Sixteen veterans undergoing lower extremity amputation received']","['PNS and standard medical therapy or standard medical therapy alone', 'temporary percutaneous PNS', 'PNS', 'Temporary (60-day) percutaneous peripheral nerve stimulation (PNS', 'Peripheral nerve stimulation']","['pain scores', 'average phantom limb pain, residual limb pain and daily opioid consumption']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}]","[{'cui': 'C0206417', 'cui_str': 'Peripheral nervous system structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0031315', 'cui_str': 'Phantom limb'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",16.0,0.0426671,"The PNS group reported greater reductions in average phantom limb pain, residual limb pain and daily opioid consumption, and there were fewer participants taking opioids through 3 months post-amputation.  ","[{'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Albright-Trainer', 'Affiliation': 'Department of Anesthesiology, Central Virginia VA Health Care System, Richmond, VA\xa023249, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Phan', 'Affiliation': 'Department of Physical Medicine & Rehab, Central Virginia VA Health Care System, Richmond, VA\xa023249, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Trainer', 'Affiliation': 'Department of Physical Medicine & Rehab, Central Virginia VA Health Care System, Richmond, VA\xa023249, USA.'}, {'ForeName': 'Nathan D', 'Initials': 'ND', 'LastName': 'Crosby', 'Affiliation': 'SPR Therapeutics, Cleveland, OH\xa044122, USA.'}, {'ForeName': 'Douglas P', 'Initials': 'DP', 'LastName': 'Murphy', 'Affiliation': 'Department of Physical Medicine & Rehab, Central Virginia VA Health Care System, Richmond, VA\xa023249, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Disalvo', 'Affiliation': 'Department of Physical Medicine & Rehab, Central Virginia VA Health Care System, Richmond, VA\xa023249, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Amendola', 'Affiliation': 'Department of Surgery, Central Virginia VA Health Care System, Richmond, VA\xa023249, USA.'}, {'ForeName': 'Denise D', 'Initials': 'DD', 'LastName': 'Lester', 'Affiliation': 'Department of Physical Medicine & Rehab, Central Virginia VA Health Care System, Richmond, VA\xa023249, USA.'}]",Pain management,['10.2217/pmt-2021-0087']
1225,34748263,Changes in bile acid subtypes and long-term successful weight-loss in response to weight-loss diets: The POUNDS lost trial.,"BACKGROUND AND AIMS


Primary bile acids (BAs) are synthesized in the liver and secondary BAs result from intestinal microbial activity. Different subtypes of BAs may be involved in regulating adiposity and energy homeostasis. We examined how changes in circulating BA subtypes induced by weight-loss diets were associated with improvements in adiposity, regional fat deposition and energy metabolism among overweight and obese adults.
METHODS


The study included 551 subjects who participated in a 2-year weight-loss diet intervention trial. Circulating 14 BA subtypes (primary and secondary unconjugated BAs and their taurine-/glycine-conjugates) were measured at baseline and 6 months. Associations of changes in BAs with changes in weight, waist circumference, resting energy expenditure (REE), body fat composition and fat distribution were evaluated.
RESULTS


Greater decreases in primary BAs (cholate and chenodeoxycholate) and secondary BAs (deoxycholate and lithocholate) and their conjugates (except for glycolithocholate) were associated with more decreases in weight and waist circumference at 6 months (P -after-false-discovery-rate-correction  [P FDR  ] < .05). We found that changes in glycocholate and glycoursodeoxycholate were consistently associated with reductions of general and central adiposity, REE, whole-body fat and visceral adipose tissue (P FDR   < .05). Further, the initial (6-month) changes in BA subtypes were differently predictive of successful weight loss over 2 years.
CONCLUSIONS


The decreases in primary and secondary BA subtypes after eating low-calorie weight-loss diets were significantly associated with improving adiposity, fat accumulation and energy metabolism, suggesting that specific BA subtypes would be predictive of long-term successful weight loss and individuals' response to the treatment of weight-loss diets.",2022,"The decreases in primary and secondary BA subtypes after eating low-calorie weight-loss diets were significantly associated with improving adiposity, fat accumulation, and energy metabolism, suggesting that specific BA subtypes would be predictive of long-term successful weight loss and individuals' response to the treatment of weight-loss diets.","['551 subjects who participated in a 2-year weight-loss diet intervention trial', 'overweight and obese adults']",[],"['adiposity, fat accumulation, and energy metabolism', 'weight and waist circumference', 'general and central adiposity, REE, whole-body fat, and visceral adipose tissue', 'adiposity, regional fat deposition, and energy metabolism', 'primary BAs (cholate and chenodeoxycholate) and secondary BAs (deoxycholate and lithocholate', 'weight, waist circumference, resting energy expenditure (REE), body fat composition, and fat distribution']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4551560', 'cui_str': 'Central obesity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0086003', 'cui_str': 'Cholates'}, {'cui': 'C0085994', 'cui_str': 'Chenodeoxycholate'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086123', 'cui_str': 'Deoxycholate'}, {'cui': 'C0086564', 'cui_str': 'Lithocholate'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",551.0,0.0654751,"The decreases in primary and secondary BA subtypes after eating low-calorie weight-loss diets were significantly associated with improving adiposity, fat accumulation, and energy metabolism, suggesting that specific BA subtypes would be predictive of long-term successful weight loss and individuals' response to the treatment of weight-loss diets.","[{'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rood', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Clary B', 'Initials': 'CB', 'LastName': 'Clish', 'Affiliation': 'Metabolomics Platform, Broad Institute of MIT and Harvard, Cambridge, Massachusetts, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.15098']
1226,34743963,Anti-caries evaluation of a nano-hydroxyapatite dental lotion for use after toothbrushing: An in situ study.,"OBJECTIVES


The aim of this randomized, double-blind, two-arm crossover in situ study was to investigate whether nano-hydroxyapatite (nanoHAP) dental lotion (Apagard Deep Care) applied immediately after tooth-brushing with nanoHAP toothpaste (Apagard M-plus) enhances the remineralization promotion and the demineralization inhibition efficacies of nanoHAP toothpastes.
METHODS


64 sound enamel blocks and 64 blocks bearing artificially-produced initial caries were produced from human permanent molar teeth. During each treatment period, lasting 14 days per arm, two blocks, one sound and one lesion-bearing, were exposed to either 5% nanoHAP-containing or placebo dental lotion after tooth-brushing with 5% nanoHAP toothpaste, via an intra-oral appliance worn by 30 adults in each of the study groups. Baseline and post-test mineral loss were quantified using transverse microradiography (TMR). One-sided t-test of one group mean was used for intragroup comparison, while two-sided t-test of two independent means was used to compare the two dental lotions.
RESULTS


Pairwise comparison (baseline vs. post-test) indicated significant (p<.001) remineralization by nanoHAP toothpaste in both groups. However, when compared against each other, there was a significantly (p<.001) greater percentage of remineralization with nanoHAP lotion [58.4(±1.8)%] than with placebo lotion [37.7(±2.2)%]. TMR examination showed absolute demineralization inhibition in sound enamel blocks exposed to either lotions.
CONCLUSIONS


Toothpaste containing 5% nanoHAP effectively remineralized initial caries and inhibited demineralization of healthy enamel; however, the application of a dental lotion containing 5% nanoHAP after brushing resulted in superior remineralization compared to a placebo lotion.
CLINICAL SIGNIFICANCE


Dental lotion containing 5% nanohydroxyapatite used immediately after toothbrushing with 5% nanohydroxyapatite toothpaste can serve as an adjunct to enhance the clinical benefits of the toothpaste.",2021,"RESULTS


Pairwise comparison (baseline vs. post-test) indicated significant (p<.001) remineralization by nanoHAP toothpaste in both groups.","['toothbrushing', '64 sound enamel blocks and 64 blocks bearing artificially-produced initial caries were produced from human permanent molar teeth']","['nanoHAP-containing or placebo dental lotion after tooth-brushing with 5% nanoHAP toothpaste, via an intra-oral appliance', 'nanoHAP toothpaste (Apagard M-plus', 'placebo lotion', 'nano-hydroxyapatite (nanoHAP) dental lotion (Apagard Deep Care', 'nano-hydroxyapatite dental lotion', 'nanoHAP lotion']",['absolute demineralization inhibition'],"[{'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0266858', 'cui_str': 'Incipient enamel caries'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0700185', 'cui_str': 'Decalcified structure'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",64.0,0.0654912,"RESULTS


Pairwise comparison (baseline vs. post-test) indicated significant (p<.001) remineralization by nanoHAP toothpaste in both groups.","[{'ForeName': 'Bennett T', 'Initials': 'BT', 'LastName': 'Amaechi', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States. Electronic address: amaechi@uthscsa.edu.'}, {'ForeName': 'Dina O', 'Initials': 'DO', 'LastName': 'Alshareif', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States.'}, {'ForeName': 'Parveez A Abdul', 'Initials': 'PAA', 'LastName': 'Azees', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States.'}, {'ForeName': 'Marina A', 'Initials': 'MA', 'LastName': 'Shehata', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States.'}, {'ForeName': 'Patricia P', 'Initials': 'PP', 'LastName': 'Lima', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Abdollahi', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States.'}, {'ForeName': 'Parisa S', 'Initials': 'PS', 'LastName': 'Kalkhorani', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Evans', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229, United States.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Bagheri', 'Affiliation': 'Department of Biology, University of Texas at San Antonio, 1 UTSA Circle, San Antonio, TX 78249, United States.'}, {'ForeName': 'Linda O', 'Initials': 'LO', 'LastName': 'Okoye', 'Affiliation': 'Faculty of Dentistry, College of Medicine, University of Nigeria, Ituku-Ozalla, Enugu, Nigeria.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103863']
1227,34748738,Patterns and Determinants of the Double Burden of Malnutrition Among Adolescents: A 14-Year Follow-Up of a Birth Cohort in Rural China.,"OBJECTIVE


To examine the prevalence of the double burden of malnutrition and its associated factors among adolescents in rural China.
STUDY DESIGN


A birth cohort of adolescents born to women in northwestern China who participated in a double-blind, randomized, controlled trial of micronutrient supplementation during pregnancy from August 2002 to January 2006 was enrolled. Follow-up was conducted from June to December 2016.
RESULTS


A total of 2115 participants were analyzed (median age 12 years; IQR ± 1), the majority of whom were male (59.7%). The nutritional status distribution was 17.72% underweight, 8.62% overweight, 0.96% obese, and 2.58% stunted. Girls were less likely to be overweight/obese (relative risk ratio [RRR] 0.67, 95% CI 0.48-0.92) but more likely to be underweight (RRR 1.65, 95% CI 1.25-2.17) or stunted (RRR 2.26, 95% CI 1.21-4.22). Children of underweight mothers (RRR 1.63, 95% CI 1.19-2.25) with a history of small for gestational age (RRR 1.64, 95% CI 1.14-2.36) or described as being a ""picky eater"" (RRR 1.53, 95% CI 1.18-1.99) had a greater risk of being underweight. Children whose fathers' education was primary or below (RRR 2.25, 95% CI 1.11-4.59), with maternal height <150.1 cm (RRR 2.46, 95% CI 1.12-5.39), or who had mothers with underweight (RRR 2.80, 95% CI 1.37-5.72) had a greater likelihood of stunting. Overweight/obesity was associated with high and middle household wealth (RRR 1.62, 95% CI 1.14-2.32), mothers with overweight (RRR 1.86, 95% CI 1.25-2.78), and picky eating (RRR 0.62, 95% CI 0.46-0.84).
CONCLUSIONS


Malnutrition (undernutrition and overweight/obesity) is common in rural Chinese adolescents and is associated with perinatal, genetic, and economic conditions.",2022,"Overweight/obesity was associated with high and middle household wealth (RRR=1.62, 95%","['adolescents in rural China', 'A 14-Year Follow-up of a Birth Cohort in Rural China', 'A birth cohort of adolescents born to women in northwestern China who participated in a double-blind', 'rural Chinese adolescents', 'during pregnancy from August 2002 to January 2006 was enrolled', 'Adolescents', 'A total of 2115 participants were analyzed (median age 12 years; IQR±1), the majority of whom were male (59.7']",['micronutrient supplementation'],"['Overweight/obesity', 'nutritional status distribution', 'picky eating']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",2115.0,0.577463,"Overweight/obesity was associated with high and middle household wealth (RRR=1.62, 95%","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elhoumed', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, P. R. China; National Institute of Public Health Research (INRSP), Nouakchott, Mauritania.""}, {'ForeName': 'Amanuel Kidane', 'Initials': 'AK', 'LastName': 'Andegiorgish', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, P. R. China; Department of Epidemiology and Biostatistics, Asmara College of Health Sciences, School of Public Health, Asmara, Eritrea.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Qi', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Mitslal Abrha', 'Initials': 'MA', 'LastName': 'Gebremedhin', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Uwimana', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Department of Nutrition and Food Safety Research, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Zhonghai', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, P. R. China.""}, {'ForeName': 'Lingxia', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, P. R. China; Key Laboratory of Environment and Genes Related to Diseases, Xi'an Jiaotong University, Ministry of Education, Xi'an, Shaanxi, P. R. China. Electronic address: tjzlx@mail.xjtu.edu.cn.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2021.10.062']
1228,34750197,PROPER-PRehabilitatiOn Plus Enhanced Recovery after surgery versus enhanced recovery after surgery in gynecologic oncology: a randomized clinical trial.,"BACKGROUND


Prehabilitation is a process that occurs before surgery and aims to improve patient functional capacity and enhance surgical recovery. This process includes medical, nutritional, physical, and psychological interventions that may reduce the duration of hospital stay and provide postoperative physical benefits.
PRIMARY OBJECTIVE


To evaluate the impact of a prehabilitation program on postoperative recovery time for patients who will undergo gynecological surgery following the Enhanced Recovery After Surgery (ERAS) guidelines.
STUDY HYPOTHESIS


A multidisciplinary, preoperative prehabilitation program for patients who will undergo gynecological surgery leads to a reduction in the length of hospital stay and improves patient functional capacity.
TRIAL DESIGN


Prospective, interventionist, and randomized controlled trial in a 1:1 ratio, open to multidisciplinary team and patients, blinded to surgeons and anesthesiologists. The control group will undergo ERAS standard preoperative care while the intervention group will have ERAS standard preoperative care plus prehabilitation.
MAJOR INCLUSION CRITERIA


Patients scheduled to undergo gynecologic surgery performed by laparotomy with a preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks.
PRIMARY ENDPOINT


To compare time between surgery and the day the patient is ready for discharge in patients who underwent the prehabilitation process versus those who did not. Readiness for discharge is defined as the ability to take care of one's-self, to walk alone, and to ingest at least 75% of daily recommended calorie intake.
SAMPLE SIZE


194 participants ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: At present, 30 patients have been recruited. Accrual should be completed by 2023-24.
TRIAL REGISTRATION


The study is approved by the IBCC - São Camilo Oncologia ethics committee (reference number 4.256.553) and is registered at clinicaltrials.gov (NCT04596800).",2022,"STUDY HYPOTHESIS


A multidisciplinary, preoperative prehabilitation program for patients who will undergo gynecological surgery leads to a reduction in the length of hospital stay and improves patient functional capacity.
","['patients who will undergo gynecological surgery leads to a reduction in the length of hospital stay and improves patient functional capacity', '194 participants', '30 patients have been recruited', 'Patients scheduled to undergo gynecologic surgery performed by laparotomy with a preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks', 'patients who will undergo gynecological surgery following the Enhanced Recovery']","['prehabilitation program', 'ERAS standard preoperative care while the intervention group will have ERAS standard preoperative care plus prehabilitation']",['postoperative recovery time'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033061', 'cui_str': 'Preoperative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.252317,"STUDY HYPOTHESIS


A multidisciplinary, preoperative prehabilitation program for patients who will undergo gynecological surgery leads to a reduction in the length of hospital stay and improves patient functional capacity.
","[{'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Lopes', 'Affiliation': 'Departamento de Ginecologia, Sao Camilo Oncologia, Sao Paulo, Brazil andrelopes.cirurgia@gmail.com.'}, {'ForeName': 'Alayne Magalhães Trindade Domingues', 'Initials': 'AMTD', 'LastName': 'Yamada', 'Affiliation': 'Núcleo de Pesquisa e Ensino da Rede São Camilo, Sao Paulo, Brazil.'}, {'ForeName': 'Thais de Campos', 'Initials': 'TC', 'LastName': 'Cardenas', 'Affiliation': 'Centro Universitário São Camilo, Sao Paulo, Brazil.'}, {'ForeName': 'Jaqueline Nunes de', 'Initials': 'JN', 'LastName': 'Carvalho', 'Affiliation': 'Serviço de Nutrição e Dietética, São Camilo Oncologia, Sao Paulo, Brazil.'}, {'ForeName': 'Emília de Azevedo', 'Initials': 'EA', 'LastName': 'Oliveira', 'Affiliation': 'Equipe Multidisciplinar, São Camilo Oncologia, Sao Paulo, Brazil.'}, {'ForeName': 'Marina Elisa Ribeiro da', 'Initials': 'MERD', 'LastName': 'Silva', 'Affiliation': 'Equipe Multidisciplinar, São Camilo Oncologia, Sao Paulo, Brazil.'}, {'ForeName': 'Juliana Fenerich Mauri', 'Initials': 'JFM', 'LastName': 'Andrade', 'Affiliation': 'Núcleo de Pesquisa e Ensino da Rede São Camilo, Sao Paulo, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'de Souza Neto', 'Affiliation': 'Departamento de Anestesiologia, Sao Camilo Oncologia, Sao Paulo, Brazil.'}, {'ForeName': 'Lilian Arruda do Rêgo', 'Initials': 'LADR', 'LastName': 'Barros', 'Affiliation': 'Núcleo de Pesquisa e Ensino da Rede São Camilo, Sao Paulo, Brazil.'}, {'ForeName': 'Ronaldo Lúcio Rangel', 'Initials': 'RLR', 'LastName': 'Costa', 'Affiliation': 'Departamento de Ginecologia, Sao Camilo Oncologia, Sao Paulo, Brazil.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2021-003170']
1229,34750564,Acute effects of alcohol on social and personal decision making.,"Social drinking is common, but it is unclear how moderate levels of alcohol influence decision making. Most prior studies have focused on adverse long-term effects on cognitive and executive function in people with alcohol use disorders (AUD). Some studies have investigated the acute effects of alcohol on decision making in healthy people, but have predominantly used small samples and focused on a narrow selection of tasks related to personal decision making, e.g., delay or probability discounting. Here, we conducted a large (n = 264), preregistered randomized placebo-controlled study (RCT) using a parallel group design, to systematically assess the acute effects of alcohol on measures of decision making in both personal and social domains. We found a robust effect of a 0.6 g/kg dose of alcohol on both moral judgment and altruistic behavior, but no effects on several measures of risk taking or waiting impulsivity. These findings suggest that alcohol at low to moderate doses selectively moderates decision making in the social domain, and promotes utilitarian decisions over those dictated by rule-based ethical principles (deontological). This is consistent with existing theory that emphasizes the dual roles of shortsighted information processing and salient social cues in shaping decisions made under the influence of alcohol. A better understanding of these effects is important to understand altered social functioning during alcohol intoxication.",2022,"We found a robust effect of a 0.6 g/kg dose of alcohol on both moral judgment and altruistic behavior, but no effects on several measures of risk taking or waiting impulsivity.","['healthy people', 'people with alcohol use disorders (AUD']","['placebo-controlled study (RCT', 'alcohol']","['cognitive and executive function', 'several measures of risk taking or waiting impulsivity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}]",,0.00613181,"We found a robust effect of a 0.6 g/kg dose of alcohol on both moral judgment and altruistic behavior, but no effects on several measures of risk taking or waiting impulsivity.","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Karlsson', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Biomedical and Clinical Sciences, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Persson', 'Affiliation': 'Department of Management and Engineering, Division of Economics, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Perini', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Biomedical and Clinical Sciences, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Yngve', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Biomedical and Clinical Sciences, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Biomedical and Clinical Sciences, Linköping University, 581 83, Linköping, Sweden. markus.heilig@liu.se.'}, {'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Tinghög', 'Affiliation': 'Department of Management and Engineering, Division of Economics, Linköping University, 581 83, Linköping, Sweden.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-01218-9']
1230,34752019,Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.,"BACKGROUND


Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age.
METHODS


A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children. In the phase 2-3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-μg doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed.
RESULTS


During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 μg was selected for further study. In the phase 2-3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18), a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, ≥0.8). Covid-19 with onset 7 days or more after the second dose was reported in three recipients of the BNT162b2 vaccine and in 16 placebo recipients (vaccine efficacy, 90.7%; 95% CI, 67.7 to 98.3).
CONCLUSIONS


A Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).",2022,No vaccine-related serious adverse events were noted.,"['751 children', '2268 children', 'children 6 months to 11 years of age', 'children 5 to 11 years of age', '5-to-11-year-old children', 'Children 5 to 11 Years of Age', '48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level', 'children younger than 12 years of age', '1517 children) or']","['BNT162b2 Covid-19 Vaccine', 'placebo', 'BNT162b2 vaccine']","['reactogenicity and immunogenicity', 'Vaccine efficacy against Covid-19', 'geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers', 'safety, immunogenicity, and efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",2268.0,0.537594,No vaccine-related serious adverse events were noted.,"[{'ForeName': 'Emmanuel B', 'Initials': 'EB', 'LastName': 'Walter', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Kawsar R', 'Initials': 'KR', 'LastName': 'Talaat', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Charu', 'Initials': 'C', 'LastName': 'Sabharwal', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Gurtman', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lockhart', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Grant C', 'Initials': 'GC', 'LastName': 'Paulsen', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Barnett', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Flor M', 'Initials': 'FM', 'LastName': 'Muñoz', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Maldonado', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Pahud', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Domachowske', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Eric A F', 'Initials': 'EAF', 'LastName': 'Simões', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Uzma N', 'Initials': 'UN', 'LastName': 'Sarwar', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kitchin', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Cunliffe', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rojo', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Kuchar', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Rämet', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Iona', 'Initials': 'I', 'LastName': 'Munjal', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Perez', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Frenck', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Lagkadinou', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Kena A', 'Initials': 'KA', 'LastName': 'Swanson', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Koury', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mather', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Belanger', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Türeci', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Dormitzer', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Şahin', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': ""From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2116298']
1231,34752990,Effectiveness of an intervention to reduce stigma towards people with a severe mental disorder diagnosis in primary health care personnel: Programme Igual-Mente.,"This study assessed the effectiveness of a program (called Igual-Mente, Equal-Mind) designed to reduce stigma in primary health care personnel. A random clinical trial was performed (ISRCTN46464036). There were 316 primary care professionals and technicians who were randomized and assigned to the experimental or control group. The program considered as strategies the education, the contact and the development of skills. There were six sessions with the primary care staff and two sessions with the managers of the health centers. It was executed by two facilitators, a professional psychologist and an expert by experience, i.e., a person diagnosed with a severe mental disorder (SMD). Attitudes, social distance, and humane treatment behaviors toward people with SMD were assessed. The intervention was effective in reducing stigma attitudes y social distance towards people diagnosed with SMD. The magnitude of the changes ranged from moderate to high in all these variables and the effects were maintained for four months after the end of the program. Regarding humane treatment behaviors, the effects were less clear. This study shows good results indicating that well-designed interventions can effectively reduce stigma towards people diagnosed with SMD, which is one of the main challenges of health systems.",2021,The magnitude of the changes ranged from moderate to high in all these variables and the effects were maintained for four months after the end of the program.,"['316 primary care professionals and technicians', 'stigma towards people with a severe mental disorder diagnosis in primary health care personnel', 'person diagnosed with a severe mental disorder (SMD', 'primary health care personnel']","['program (called Igual-Mente, Equal-Mind']","['stigma attitudes y social distance', 'Attitudes, social distance, and humane treatment behaviors toward people with SMD']","[{'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}]",316.0,0.00993493,The magnitude of the changes ranged from moderate to high in all these variables and the effects were maintained for four months after the end of the program.,"[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Grandón', 'Affiliation': 'Psychology Department, Universidad de Concepcion, Concepcion, Chile. Electronic address: pgrandon@udec.cl.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Saldivia', 'Affiliation': 'Psychiatric Department, Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Cova', 'Affiliation': 'Psychology Department, Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bustos', 'Affiliation': 'Psychology Department, Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Vaccari', 'Affiliation': 'Psychology Department, Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Ramírez-Vielma', 'Affiliation': 'Psychology Department, Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Vielma-Aguilera', 'Affiliation': 'Psychiatric Department, Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zambrano', 'Affiliation': 'Recovery Group, Concepcion, Chile.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Ortiz', 'Affiliation': 'Psychology Department, Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Knaak', 'Affiliation': 'Social Sciences Department, University of Calgary, Calgary, Canada.'}]",Psychiatry research,['10.1016/j.psychres.2021.114259']
1232,34762980,"Transcranial magnetic stimulation for sleep disorders in Alzheimer's disease: A double-blind, randomized, and sham-controlled pilot study.","BACKGROUND


Sleep disorders are commonly comorbid with Alzheimer's disease (AD), And these disorders interfere with each other in many aspects. To date, pharmacological treatments for sleep disorders are still limited, and studies investigating repetitive transcranial magnetic stimulation (rTMS) for sleep disorders in AD are still lacking.
METHOD


A single-center, randomized, double-blind, parallel-arm, and sham-controlled pilot study was conducted in AD patients with sleep disorders. Seventy subjects were randomly divided into the following two groups: the sham group (SG) and the intervention group (IG). We evaluated sleep changes using the Pittsburgh Sleep Quality Index (PSQI) before and after the intervention. We also assessed the patients' cognitive function by the Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-Cog). The intervention period was four weeks, and the patients were followed up in the 8th week to test the persistence of the effect of the rTMS intervention.
RESULT


Significant differences in the PSQI scores were found between the SG and IG at the end of the 4-week intervention (P = 0.001) and the 8-week follow-up (P < 0.001). There was also significant improvement in ADAS-Cog scores (4 weeks: P = 0.048, 8 weeks: P = 0.038). Activities of daily living (ADL) did not significantly differ between the SG and IG.
CONCLUSION


rTMS can effectively ameliorate sleep disorders in AD patients.",2022,Significant differences in the PSQI scores were found between the SG and IG at the end of the 4-week intervention (P = 0.001) and the 8-week follow-up (P < 0.001).,"['AD patients with sleep disorders', 'Seventy subjects', 'AD patients', ""Alzheimer's disease patients""]","['rTMS intervention', 'transcranial magnetic stimulation', 'repetitive transcranial magnetic stimulation (rTMS', 'rTMS']","['Activities of daily living (ADL', 'PSQI scores', 'Pittsburgh Sleep Quality Index (PSQI', ""patients' cognitive function by the Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-Cog"", 'ADAS-Cog scores', 'sleep disorders']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}]",70.0,0.10001,Significant differences in the PSQI scores were found between the SG and IG at the end of the 4-week intervention (P = 0.001) and the 8-week follow-up (P < 0.001).,"[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Graduate School of Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China; Department of Neurology, China-Japan Friendship Hospital, Beijing, China. Electronic address: DDDDDX2021@163.com.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China-Japan Friendship Hospital, Beijing, China; Peking University China-Japan Friendship School of Clinical Medicine, Beijing, China. Electronic address: vivivax@163.com.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': 'Department of Neurology, China-Japan Friendship Hospital, Beijing, China; Peking University China-Japan Friendship School of Clinical Medicine, Beijing, China. Electronic address: 1911110635@pku.edu.cn.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China. Electronic address: liyimingcv@foxmail.com.'}, {'ForeName': 'Shuhong', 'Initials': 'S', 'LastName': 'Jia', 'Affiliation': 'Department of Neurology, China-Japan Friendship Hospital, Beijing, China. Electronic address: xixiray@gmail.com.'}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Niu', 'Affiliation': 'Peking University China-Japan Friendship School of Clinical Medicine, Beijing, China. Electronic address: 1364551250@qq.com.'}, {'ForeName': 'Dantao', 'Initials': 'D', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, Graduate School of Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China; Department of Neurology, China-Japan Friendship Hospital, Beijing, China; Peking University China-Japan Friendship School of Clinical Medicine, Beijing, China. Electronic address: pengdantao2000@163.com.'}]",Neuroscience letters,['10.1016/j.neulet.2021.136337']
1233,34750035,First-line Nivolumab plus Ipilimumab Versus Sunitinib in Patients Without Nephrectomy and With an Evaluable Primary Renal Tumor in the CheckMate 214 Trial.,"We present an exploratory post hoc analysis from the phase 3 CheckMate 214 trial of first-line nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib in a subgroup of 108 patients with advanced renal cell carcinoma (aRCC) without prior nephrectomy and with an evaluable primary tumor, a population under-represented in clinical trials. Patients with clear cell aRCC were randomized to NIVO+IPI every 3 wk for four doses followed by NIVO monotherapy, or sunitinib every day for 4 wk (6-wk cycle). Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and primary tumor shrinkage were assessed. PFS and ORR were assessed per independent radiology review committee using RECIST version 1.1. With minimum study follow-up of 4 yr for intent-to-treat patients, OS favored NIVO+IPI (n = 53) over sunitinib (n = 55; hazard ratio 0.63, 95% confidence interval 0.40-1.0) among patients without prior nephrectomy. ORR was higher (34% vs 15%; p = 0.0041) and median duration of response was longer with NIVO+IPI versus sunitinib (20.5 vs 14.1 mo); the best overall response was partial response in either arm. A ≥30% reduction in the diameter of intact target renal tumors was achieved in 35% of patients with NIVO+IPI versus 20% with sunitinib. Safety was consistent with the global study population. In conclusion, in patients with aRCC without prior nephrectomy and with an evaluable primary tumor, NIVO+IPI showed survival benefits and renal tumor reduction versus sunitinib. This trial is registered at ClinicalTrials.gov as NCT02231749. PATIENT SUMMARY: In an exploratory analysis of a large global trial (CheckMate 214), we observed positive outcomes (both survival and tumor response to treatment) with nivolumab plus ipilimumab over sunitinib in a subgroup of patients with advanced kidney cancer who did not undergo removal of their primary kidney tumor. This subset of patients represents a population that has not been studied in clinical trials and for whom outcomes with new immunotherapy combination regimens are not yet known. We conclude that treatment with nivolumab plus ipilimumab offers these patients a survival benefit versus sunitinib, consistent with that observed in the overall study, as well as a notable kidney tumor reduction.",2022,ORR was higher (34% vs 15%; p = 0.0041) and median duration of response was longer with NIVO+IPI versus sunitinib (20.5 vs 14.1 mo); the best overall response was partial response in either arm.,"['patients with advanced kidney cancer who did not undergo removal of their primary kidney tumor', 'Patients Without Nephrectomy and With an Evaluable Primary Renal Tumor in the CheckMate 214 Trial', '108 patients with advanced renal cell carcinoma (aRCC) without prior nephrectomy and with an evaluable primary tumor, a population under-represented in clinical trials', 'Patients with clear cell aRCC']","['nivolumab plus ipilimumab', 'nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib', 'First-line Nivolumab plus Ipilimumab Versus Sunitinib', 'NIVO monotherapy, or sunitinib']","['survival benefit', 'survival benefits and renal tumor reduction', 'ORR', 'Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and primary tumor shrinkage', 'diameter of intact target renal tumors', 'median duration of response', 'PFS and ORR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0022665', 'cui_str': 'Neoplasm of kidney'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0022665', 'cui_str': 'Neoplasm of kidney'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",108.0,0.200007,ORR was higher (34% vs 15%; p = 0.0041) and median duration of response was longer with NIVO+IPI versus sunitinib (20.5 vs 14.1 mo); the best overall response was partial response in either arm.,"[{'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Department of Cancer Medicine, Gustave Roussy, Villejuif, France. Electronic address: laurence.albiges@gustaveroussy.fr.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Burotto', 'Affiliation': 'Bradford Hill Clinical Research Center, Santiago, Chile.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McDermott', 'Affiliation': 'Division of Medical Oncology, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Department of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Barthélémy', 'Affiliation': 'Medical Oncology, Institut de Cancérologie Strasbourg Europe, Strasbourg, France.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'University of Pavia, Pavia, Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Department of Urology, Barts Cancer Institute, Queen Mary University of London, Royal Free NHS Trust, London, UK.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Kollmannsberger', 'Affiliation': 'Department of Medicine, British Columbia Cancer Agency, Vancouver, Canada.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Department of Medical Oncology, Westmead Hospital and Macquarie University, Sydney, Australia.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': 'Medical Oncology Service, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Division of Hematology Oncology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Department of Medical Oncology, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leung', 'Affiliation': 'Department of Imaging, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Shruti Shally', 'Initials': 'SS', 'LastName': 'Saggi', 'Affiliation': 'Department of Clinical Trials, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Chung-Wei', 'Initials': 'CW', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Trials, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Department of Biostatistics, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",European urology,['10.1016/j.eururo.2021.10.001']
1234,34751456,Does the interference phenomenon affect strength development during same-session combined rehabilitation program in hemodialysis patients?,"INTRODUCTION


This study aimed to assess if an interference effect could blunt the neuromuscular gains induced by a same-session combined rehabilitation in hemodialysis (HD) patients.
METHODS


Patients exercised twice a week, for 16 weeks, over their HD sessions. They were either always trained with resistance and endurance exercises (continuous training, ""CONT"") or alternatively with 1 week of resistance alternated with 1 week of endurance (discontinuous training, ""DISC""). Adherence and workload were continuously recorded. Short Physical Performance Battery (SPPB) score, one-leg balance test, and handgrip and quadriceps strength were evaluated before and after training intervention.
RESULTS


Adherence to both programs was high (>90%). SPPB score had significantly improved (CONT: +1.5 point, DISC: +1.2 pt, p < 0.001), like one-leg balance test (CONT: +3.7 s, DISC: +5.5 s, p < 0.05), handgrip strength of exercised (CONT: +5.5 kg, DISC: +5.6 kg, p < 0.001) and of nonexercised arm (CONT: +4.4 kg, DISC: +2.8 kg, p < 0.01) as well as maximal quadriceps strength (+22 N·m for dominant and +29 N·m for nondominant leg in both groups, p < 0.001) bearing no difference between the trainings.
CONCLUSION


Same-session combined training does not induce an interference effect in HD patients and temporal separation of exercises does not optimize strength gains. These practical data may be relevant for clinicians and practitioners to alternate endurance and resistance exercises.",2022,"SPPB score had significantly improved (CONT: +1.5 point, DISC: +1.2 pt, p < 0.001), like one-leg balance test (CONT: +3.7 s, DISC: +5.5 s, p < 0.05), handgrip strength of exercised (CONT: +5.5 kg, DISC: +5.6 kg, p < 0.001) and of nonexercised arm (CONT: +4.4 kg, DISC: +2.8 kg, p < 0.01) as well as maximal quadriceps strength (+22 N·m for dominant and +29 N·m for nondominant leg in both groups, p < 0.001) bearing no difference between the trainings.
","['hemodialysis patients', 'hemodialysis (HD) patients']","['resistance and endurance exercises (continuous training, ""CONT"") or alternatively with 1\u2009week of resistance alternated with 1\u2009week of endurance (discontinuous training, ""DISC']","['SPPB score', 'like one-leg balance test', 'Adherence and workload', 'maximal quadriceps strength', 'handgrip strength of exercised', 'Short Physical Performance Battery (SPPB) score, one-leg balance test, and handgrip and quadriceps strength']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0439599', 'cui_str': 'Discontinuous'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.00923153,"SPPB score had significantly improved (CONT: +1.5 point, DISC: +1.2 pt, p < 0.001), like one-leg balance test (CONT: +3.7 s, DISC: +5.5 s, p < 0.05), handgrip strength of exercised (CONT: +5.5 kg, DISC: +5.6 kg, p < 0.001) and of nonexercised arm (CONT: +4.4 kg, DISC: +2.8 kg, p < 0.01) as well as maximal quadriceps strength (+22 N·m for dominant and +29 N·m for nondominant leg in both groups, p < 0.001) bearing no difference between the trainings.
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pavlin', 'Affiliation': 'DMEM, UMR866, INRAE, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'Fondation Charles Mion - AIDER Santé, AIDER Santé, Montpellier, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ohresser', 'Affiliation': 'Fondation Charles Mion - AIDER Santé, AIDER Santé, Montpellier, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Larivière', 'Affiliation': 'Fondation Charles Mion - AIDER Santé, AIDER Santé, Montpellier, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Portal', 'Affiliation': 'Fondation Charles Mion - AIDER Santé, AIDER Santé, Montpellier, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Cristol', 'Affiliation': 'Department of Biochemistry, University Hospital of Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Bernardi', 'Affiliation': 'DMEM, UMR866, INRAE, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Turc-Baron', 'Affiliation': 'Fondation Charles Mion - AIDER Santé, AIDER Santé, Montpellier, France.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Candau', 'Affiliation': 'DMEM, UMR866, INRAE, University of Montpellier, Montpellier, France.'}]",Seminars in dialysis,['10.1111/sdi.13033']
1235,34757584,Examining Ways to Improve Weight Control Programs' Population Reach and Representativeness: A Discrete Choice Experiment of Financial Incentives.,"BACKGROUND


Both theoretical and empirical evidence supports the potential of modest financial incentives to increase the reach of evidence-based weight control programs. However, few studies exist that examine the best incentive design for achieving the highest reach and representativeness at the lowest cost and whether or not incentive designs may be valued differentially by subgroups that experience obesity-related health disparities.
METHODS


A discrete choice experiment was conducted (n = 1232 participants; over 90% of them were overweight/obese) to collect stated preference towards different financial incentive attributes, including reward amount, program location, reward contingency, and payment form and frequency. Mixed logit and conditional logit models were used to determine overall and subgroup preference ranking of attributes. Using the National Health and Nutrition Examination Survey data sample weights and the estimated models, we predicted US nationally representative participation rates by subgroups and examined the effect of offering more than one incentive design. External validity was checked by using a completed cluster randomized control trial.
RESULTS


There were significant subgroup differences in preference toward incentive attributes. There was also a sizable negative response to larger incentive amounts among African Americans, suggesting that higher amounts would reduce participation from this population. We also find that offering participants a menu of incentive designs to choose from would increase reach more than offering higher reward amounts.
CONCLUSIONS


We confirmed the existence of preference heterogeneity and the importance of subgroup-targeted incentive designs in any evidence-based weight control program to maximize population reach and reduce health disparities.",2022,There were significant subgroup differences in preference toward incentive attributes.,"['Representativeness', 'A discrete choice experiment was conducted (n\xa0=\xa01232 participants; over 90% of them were overweight/obese', 'African Americans']",[],"['preference toward incentive attributes', 'External validity']","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0085756', 'cui_str': 'African American'}]",[],"[{'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",1232.0,0.0795207,There were significant subgroup differences in preference toward incentive attributes.,"[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Department of Public Health Science, School of Medicine, University of Virginia, University of Virginia Cancer Center, Charlottesville, VA, USA. wenyou@virginia.edu.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Convoy Inc., Seattle, WA, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Boyle', 'Affiliation': 'Department of Agricultural and Applied Economics, Willis Blackwood Real Estate, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Tzeyu L', 'Initials': 'TL', 'LastName': 'Michaud', 'Affiliation': 'Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Parmeter', 'Affiliation': 'Department of Economics, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Seidel', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Virginia Tech Carilion School of Medicine, Roanoke, VA, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Estabrooks', 'Affiliation': 'Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE, USA.'}]",PharmacoEconomics - open,['10.1007/s41669-021-00310-6']
1236,34753859,Performance Nutrition for Physician Trainees Working Overnight Shifts: A Randomized Controlled Trial.,"PURPOSE


To compare acute effects of 2 dietary interventions with usual dietary habits on physician trainees' alertness during overnight shifts.
METHOD


This registered, controlled, block randomized crossover trial (NCT03698123) was conducted between October 2018 and May 2019 at Stanford Medicine. Physician trainees working at least 3 overnight shifts during a 1-week period were recruited. During the first night, participants followed their usual dietary habits. During the intervention nights (low carbohydrate-to-protein ratio and high carbohydrate-to-protein ratio interventions), participants received healthy dinners, snacks, water, and, upon request, caffeinated beverages, at the beginning of their shifts and were instructed to eat meals before 10 pm. The sequence of interventions on the second and third nights were block randomized across study weeks. Outcome measures (a priori) were overnight changes in validated measures of specific neurobehavioral dimensions: psychomotor vigilance, sensory-motor speed, working memory, and risk decision making, as well as self-reported sleepiness and work exhaustion.
RESULTS


Sixty-one physician trainees participated in this study. Compared with usual dietary habits, overnight changes in psychomotor vigilance scores (scale 0-1,000) improved by 51.02 points (95% CI: 12.08, 89.96) and sleepiness (scale 1-7) improved by 0.69 points (95% CI: 0.33, 1.05) under the low carbohydrate-to-protein ratio intervention. Compared with usual dietary habits, overnight changes in sleepiness (scale 1-7) improved by 0.61 points (95% CI: 0.25, 0.96) under the high carbohydrate-to-protein ratio intervention. Neither intervention had beneficial effects relative to usual dietary habits with respect to sensory-motor speed, working memory, risk decision making, or work exhaustion. There were no differences in outcomes between low carbohydrate-to-protein ratio and high carbohydrate-to-protein ratio interventions.
CONCLUSIONS


Dietary interventions may mitigate negative effects of physician trainee sleep deprivation during overnight shifts. Future studies are warranted to further examine the effectiveness of nutritional strategies on physician alertness during overnight shifts.",2022,"Neither intervention had beneficial effects relative to usual dietary habits with respect to sensory-motor speed, working memory, risk decision-making, or work exhaustion.","['Sixty-one physician trainees', 'Physician trainees working at least 3 overnight shifts during a 1-week period were recruited', 'October 2018 and May 2019 at Stanford Medicine', 'Physician Trainees']","['Working Overnight Shifts', 'intervention nights (low carbohydrate-to-protein ratio and high carbohydrate-to-protein ratio interventions', '2 dietary interventions with usual dietary habits']","['specific neurobehavioral dimensions: psychomotor vigilance, sensory-motor speed, working memory, and risk decision-making, as well as self-reported sleepiness and work exhaustion', 'psychomotor vigilance scores', 'sensory-motor speed, working memory, risk decision-making, or work exhaustion']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0583218,"Neither intervention had beneficial effects relative to usual dietary habits with respect to sensory-motor speed, working memory, risk decision-making, or work exhaustion.","[{'ForeName': 'Maryam S', 'Initials': 'MS', 'LastName': 'Makowski', 'Affiliation': 'M.S. Makowski is clinical assistant professor, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California; ORCID: https://orcid.org/0000-0003-0823-5376.'}, {'ForeName': 'Mickey T', 'Initials': 'MT', 'LastName': 'Trockel', 'Affiliation': 'M.T. Trockel is clinical professor, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California; ORCID: https://orcid.org/0000-0001-7191-5791.'}, {'ForeName': 'Nikitha K', 'Initials': 'NK', 'LastName': 'Menon', 'Affiliation': 'N.K. Menon is social science research professional, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California; ORCID: https://orcid.org/0000-0001-6443-1561.'}, {'ForeName': 'Hanhan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'H. Wang is a biostatistician, Stanford Medicine WellMD and WellPhD Center, Stanford University School of Medicine, Stanford, California; ORCID: https://orcid.org/0000-0003-4076-3443.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Katznelson', 'Affiliation': 'L. Katznelson is professor of neurosurgery and medicine, Departments of Neurosurgery and Medicine, and associate dean of graduate medical education, Stanford University School of Medicine, Stanford, California; ORCID: https://orcid.org/0000-0001-8115-5714.'}, {'ForeName': 'Tait D', 'Initials': 'TD', 'LastName': 'Shanafelt', 'Affiliation': 'T.D. Shanafelt is professor of medicine, Department of Medicine, chief wellness officer, Stanford Medicine, and associate dean, Stanford University School of Medicine, Stanford, California; ORCID: https://orcid.org/0000-0002-7106-5202.'}]",Academic medicine : journal of the Association of American Medical Colleges,['10.1097/ACM.0000000000004509']
1237,34756180,"The clinical and microbiological efficacy of temocillin versus cefotaxime in adults with febrile urinary tract infection, and its effects on the intestinal microbiota: a randomised multicentre clinical trial in Sweden.","BACKGROUND


Use of third-generation cephalosporins, such as cefotaxime, is associated with an increased risk of selection for antimicrobial resistance, so alternative antibiotics need to be considered. The aim of the present study was to evaluate intestinal colonisation with third-generation cephalosporin-resistant pathogens following use of temocillin-an alternative antibiotic to cefotaxime that is potentially less prone to disturbing the intestinal microbiota-in empirical treatment of febrile urinary tract infection (UTI).
METHODS


We did a randomised, multicentre, superiority, open-label phase 4 trial in patients who had been admitted to inpatient care in 12 Swedish hospitals with suspected or diagnosed febrile UTI (complicated or uncomplicated). To meet inclusion criteria, a patient was required to have at least one sign or symptom of pyelonephritis (ie, flank pain; costovertebral angle tenderness; and changes to urinary frequency or urgency or dysuria), a fever of 38·0°C or higher, and a positive urine dipstick (for nitrites, white blood cells, or both). Participants were also required to have an indication for intravenous antibiotic treatment. Participants were randomly assigned (1:1) to receive either 2 g temocillin or 1-2 g cefotaxime, by local investigators opening consecutive sealed randomisation envelopes that were generated centrally in advance. Both drugs were administered intravenously every 8 h. The trial was open label for investigators and patients, but those doing the microbiological analyses were masked to the groups. Participants were treated with antibiotics for 7-10 days (or up to 14 days if they had bacteraemia), at least 3 days of which were on the study drug; at day 4 and later, participants who were showing improvement could be given an oral antibiotic (ciprofloxacin, ceftibuten, cefixime, or co-trimoxazole). Patients not showing improvement were regarded as having treatment failures. Rectal swabs were collected at three timepoints: at baseline (before the first dose), after the last dose of study drug, and 7-10 days after treatment stopped. The composite primary outcome was colonisation with Enterobacterales with reduced susceptibility to third-generation cephalosporins, or colonisation with toxin-producing Clostridioides difficile, or both, to evaluate disturbance of the intestinal microbiota. The study is registered in the EU Clinical Trials Register (EudraCT 2015-003898-15).
FINDINGS


Between May 20, 2016, and July 31, 2019, 207 patients were screened for eligibility, of whom 55 patients were excluded. 152 participants were randomly assigned to groups: 77 (51%) patients received temocillin, 75 (49%) patients received cefotaxime. The composite primary endpoint was met by 18 (26%) of 68 participants receiving temocillin versus 30 (48%) of 62 patients receiving cefotaxime (risk difference -22% [95% CI -42% to -3%]), showing superiority of temocillin versus cefotaxime (ie, less disturbance of the intestinal microbiota). 43 adverse events were reported in 40 (52%) of 77 patients in the temocillin group, versus 46 adverse events in 34 (45%) of 75 patients in the cefotaxime group. Most events were of mild to moderate severity. 21 (27%) patients in the temocillin and 17 (23%) patients in the cefotaxime group had an adverse event that was considered to be associated with the study drug.
INTERPRETATION


Temocillin was found to be less selective than cefotaxime of Enterobacterales with reduced susceptibility to third-generation cephalosporins, and it could therefore be a favourable alternative in the empirical treatment of febrile UTI. Use of this antibiotic could reduce hospital transmission and health-care-associated infections by these pathogens.
FUNDING


Public Health Agency of Sweden.",2022,"INTERPRETATION


Temocillin was found to be less selective than cefotaxime of Enterobacterales with reduced susceptibility to third-generation cephalosporins, and it could therefore be a favourable alternative in the empirical treatment of febrile UTI.","['152 participants', '207 patients were screened for eligibility, of whom 55 patients were excluded', 'Between May 20, 2016, and July 31, 2019', 'adults with febrile urinary tract infection', 'patient was required to have at least one sign or symptom of pyelonephritis (ie, flank pain; costovertebral angle tenderness; and changes to urinary frequency or urgency or dysuria), a fever of 38·0°C or higher, and a positive urine dipstick (for nitrites, white blood cells, or both', 'patients who had been admitted to inpatient care in 12 Swedish hospitals with suspected or diagnosed febrile UTI (complicated or uncomplicated']","['2 g temocillin or 1-2 g cefotaxime', 'antibiotics', 'temocillin versus cefotaxime', 'oral antibiotic (ciprofloxacin, ceftibuten, cefixime, or co-trimoxazole', 'cefotaxime']","['colonisation with Enterobacterales with reduced susceptibility to third-generation cephalosporins, or colonisation with toxin-producing Clostridioides difficile, or both, to evaluate disturbance of the intestinal microbiota', '43 adverse events', 'adverse event']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3875265', 'cui_str': 'Febrile urinary tract infection'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034186', 'cui_str': 'Pyelonephritis'}, {'cui': 'C0016199', 'cui_str': 'Flank pain'}, {'cui': 'C0235634', 'cui_str': 'Renal angle tenderness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0441090', 'cui_str': 'Dipstick'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C0076079', 'cui_str': 'temocillin'}, {'cui': 'C0007554', 'cui_str': 'Cefotaxime'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0055014', 'cui_str': 'ceftibuten'}, {'cui': 'C0060400', 'cui_str': 'Cefixime'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0304320', 'cui_str': 'Third generation cephalosporin'}, {'cui': 'C0040549', 'cui_str': 'Toxin'}, {'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",152.0,0.208314,"INTERPRETATION


Temocillin was found to be less selective than cefotaxime of Enterobacterales with reduced susceptibility to third-generation cephalosporins, and it could therefore be a favourable alternative in the empirical treatment of febrile UTI.","[{'ForeName': 'Charlotta', 'Initials': 'C', 'LastName': 'Edlund', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ternhag', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden; Division of Infectious Diseases, Department of Medicine, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Skoog Ståhlgren', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Edquist', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Åse', 'Initials': 'Å', 'LastName': 'Östholm Balkhed', 'Affiliation': 'Division of Infectious Diseases, Department of Biomedical and Clinical Sciences, Faculty of Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Athlin', 'Affiliation': 'Department of Infectious Diseases, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Emeli', 'Initials': 'E', 'LastName': 'Månsson', 'Affiliation': 'Department of Infectious Diseases and Centre of Clinical Research, Västmanland Hospital, Västerås, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tempé', 'Affiliation': 'Sundsvall Härnösand Regional Hospital, Sundsvall, Sweden.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Bergström', 'Affiliation': 'The Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Christian G', 'Initials': 'CG', 'LastName': 'Giske', 'Affiliation': 'Division of Clinical Microbiology, Department of Laboratory Medicine, Karolinska Institutet, Solna, Sweden; Clinical Microbiology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Hanberger', 'Affiliation': 'Division of Infectious Diseases, Department of Biomedical and Clinical Sciences, Faculty of Medicine, Linköping University, Linköping, Sweden. Electronic address: hakan.hanberger@liu.se.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(21)00407-2']
1238,34758629,Experience of participants with chronic pain in a pilot randomized clinical trial using a ketogenic diet.,"Aim:  To report the experience of chronic pain participants after a well-formulated ketogenic diet (WFKD) or whole-food diet (WFD). The quantitative outcomes for this trial have been published separately (clinical trial registration number ACTRN12620000946910).  Patients & methods:  The experience of 24 participants was evaluated after 12 and 24 weeks of dietary intervention using survey responses and open questions.  Results & conclusion:  Retention rates for the WFKD and WFD groups were 93 and 89%, respectively. Average adherence to the WFKD was 82% and to the WFD was 87%. The WFKD enjoyment was rated at 66 and 81% for the WFD group. The ease of adhering to the diet varied more widely for the WFKD group. Barriers included knowledge integration, time management, navigating social food environments and emotional attachment to eliminated foods. Facilitators included structured support and coaching, and comprehensive learning materials. The WFKD was shown to be a feasible and effective treatment option for chronic pain.",2022,The WFKD enjoyment was rated at 66 and 81% for the WFD group.,"['participants with chronic pain', 'chronic pain participants after a', '24 participants was evaluated after 12 and 24 weeks of']","['well-formulated ketogenic diet (WFKD) or whole-food diet (WFD', 'dietary intervention', 'ketogenic diet', 'structured support and coaching, and comprehensive learning materials']","['knowledge integration, time management, navigating social food environments and emotional attachment to eliminated foods', 'Retention rates', 'Average adherence to the WFKD', 'WFKD enjoyment']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0453870', 'cui_str': 'Whole food'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]",24.0,0.0895868,The WFKD enjoyment was rated at 66 and 81% for the WFD group.,"[{'ForeName': 'Rowena J', 'Initials': 'RJ', 'LastName': 'Field', 'Affiliation': 'Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Tara J', 'Initials': 'TJ', 'LastName': 'Field', 'Affiliation': 'The New South Wales Ministry of Health (NSW Health), Sydney, Australia.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Pourkazemi', 'Affiliation': 'Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Kieron B', 'Initials': 'KB', 'LastName': 'Rooney', 'Affiliation': 'Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.'}]",Pain management,['10.2217/pmt-2021-0084']
1239,34762753,Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants.,,2022,,['preterm infants'],['azithromycin'],[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}]",[],,0.165575,,"[{'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Gandecha', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Boyle', 'Affiliation': 'University of Leicester, Leicester, UK.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.16159']
1240,34756645,Clinical outcomes of potential high responders after individualized FSH dosing based on anti-Müllerian hormone and body weight.,"RESEARCH QUESTION


How does the efficacy and safety of individualized follitropin delta dosing compare with conventional dosing for ovarian stimulation in potential high responders?
DESIGN


Retrospective analysis of 153 potential high responders identified on the basis of baseline serum anti-Müllerian hormone (AMH) levels above 35 pmol/l, who were originally randomized to an individualized fixed dose of follitropin delta based on AMH and body weight (n = 78) or to a daily starting dose of 150 IU follitropin alfa (n = 75).
RESULTS


At the end of stimulation, patients treated with individualized follitropin delta or conventional follitropin alfa had 12.1 ± 7.0 and 18.3 ± 7.0 (P < 0.001) follicles measuring 12 mm or wider, and 27.3% and 62.7% had serum progesterone levels higher than 3.18 nmol/l (P < 0.001), respectively. Overall number of oocytes in these two respective arms was 9.3 ± 6.7 and 17.9 ± 8.7 (P < 0.001), and the ongoing pregnancy rate per started cycle after fresh blastocyst transfer was 28.2% and 24.0%. The risk of ovarian hyperstimulation syndrome (OHSS) for all cases was three times higher in the conventional follitropin alfa arm at 16.0% versus 5.1% with individualized follitropin delta treatment (P = 0.025) and 26.7% versus 7.7% (P = 0.001) for early moderate or severe OHSS, preventive interventions for early OHSS, or both.
CONCLUSIONS


Treatment with individualized follitropin delta provides an improved efficacy-safety balance in women with high ovarian reserve, as it normalizes the ovarian response and decreases the risk of OHSS without compromising the chance of pregnancy.",2021,"The risk of ovarian hyperstimulation syndrome (OHSS) for all cases was three times higher in the conventional follitropin alfa arm at 16.0% versus 5.1% with individualized follitropin delta treatment (P = 0.025) and 26.7% versus 7.7% (P = 0.001) for early moderate or severe OHSS, preventive interventions for early OHSS, or both.
","['women with high ovarian reserve', '153 potential high responders identified on the basis of baseline serum anti-Müllerian hormone (AMH) levels above 35 pmol/l']","['follitropin delta based on AMH and body weight (n\u202f=\u202f78) or to a daily starting dose of 150 IU follitropin alfa', 'individualized follitropin delta or conventional follitropin alfa']","['ongoing pregnancy rate', 'anti-Müllerian hormone and body weight', 'Overall number of oocytes', 'risk of ovarian hyperstimulation syndrome (OHSS', 'serum progesterone levels', 'efficacy-safety balance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439284', 'cui_str': 'pmol/L'}]","[{'cui': 'C4301617', 'cui_str': 'follitropin delta'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1268876', 'cui_str': 'Follitropin Alfa'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C0428410', 'cui_str': 'Serum progesterone measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",153.0,0.0564744,"The risk of ovarian hyperstimulation syndrome (OHSS) for all cases was three times higher in the conventional follitropin alfa arm at 16.0% versus 5.1% with individualized follitropin delta treatment (P = 0.025) and 26.7% versus 7.7% (P = 0.001) for early moderate or severe OHSS, preventive interventions for early OHSS, or both.
","[{'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Višnová', 'Affiliation': 'IVF Cube, Fertility Clinic, Evropská 423, Prague 160 00, Czech Republic.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Papaleo', 'Affiliation': 'IRCCS San Raffaele Hospital, Via Olgettina 60, Milan 20132.'}, {'ForeName': 'Fernando Sánchez', 'Initials': 'FS', 'LastName': 'Martin', 'Affiliation': 'Ginemed, Calle Farmaceutico Murillo Herrera 3 Sevilla 41010, Spain.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Koziol', 'Affiliation': 'nOvum Fertility Clinic, Bociania 13 Warsaw 02-807, Poland.'}, {'ForeName': 'Bjarke M', 'Initials': 'BM', 'LastName': 'Klein', 'Affiliation': 'Ferring Pharmaceuticals, Global Biometrics, Kay Fiskers Plads 11, Copenhagen DK-2300, Denmark.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Mannaerts', 'Affiliation': 'Ferring Pharmaceuticals, Reproductive Medicine and Maternal Health, Kay Fiskers Plads 11, Copenhagen DK-2300, Denmark. Electronic address: Bernadette.Mannaerts@ferring.com.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2021.08.024']
1241,34753304,Endovascular Treatment for Posterior Circulation Stroke in Routine Clinical Practice: Results of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Registry.,"BACKGROUND AND PURPOSE


The benefit of endovascular treatment (EVT) for posterior circulation stroke (PCS) remains uncertain, and little is known on treatment outcomes in clinical practice. This study evaluates outcomes of a large PCS cohort treated with EVT in clinical practice. Simultaneous to this observational study, several intervention centers participated in the BASICS trial (Basilar Artery International Cooperation Study), which tested the efficacy of EVT for basilar artery occlusion in a randomized setting. We additionally compared characteristics and outcomes of patients treated outside BASICS in trial centers to those from nontrial centers.
METHODS


We included patients with PCS from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Registry: a prospective, multicenter, observational study of patients who underwent EVT in the Netherlands between 2014 and 2018. Primary outcome was a score of 0 to 3 on the modified Rankin Scale at 90 days. Secondary outcomes included reperfusion status and symptomatic intracranial hemorrhage. For outcome comparison between patients treated in trial versus nontrial centers, we used ordinal logistic regression analysis.
RESULTS


We included 264 patients of whom 135 (51%) had received intravenous thrombolysis. The basilar artery was most often involved (77%). Favorable outcome (modified Rankin Scale score 0-3) was observed in 115/252 (46%) patients, and 109/252 (43%) patients died. Successful reperfusion was achieved in 178/238 (75%), and symptomatic intracranial hemorrhage occurred in 9/264 (3%). The 154 nontrial patients receiving EVT in BASICS trial centers had similar characteristics and outcomes as the 110 patients treated in nontrial centers (modified Rankin Scale adjusted cOR: 0.77 [95% CI, 0.5-1.2]).
CONCLUSIONS


Our study shows that high rates of favorable clinical outcome and successful reperfusion can be achieved with EVT for PCS, despite high mortality. Characteristics and outcomes of patients treated in trial versus nontrial centers were similar indicating that our cohort is representative of clinical practice in the Netherlands. Randomized studies using modern treatment approaches are needed for further insight in the benefit of EVT for PCS.",2022,"Favorable outcome (modified Rankin Scale score 0-3) was observed in 115/252 (46%) patients, and 109/252 (43%) patients died.","['posterior circulation stroke (PCS', '154 nontrial patients receiving', 'patients treated outside BASICS in trial centers to those from nontrial centers', 'patients with PCS', '264 patients of whom 135 (51%) had received', 'patients who underwent EVT in the Netherlands between 2014 and 2018', 'Acute Ischemic Stroke in the Netherlands Registry']","['intravenous thrombolysis', 'EVT', 'endovascular treatment (EVT', 'Endovascular Treatment']","['Favorable outcome (modified Rankin Scale score 0-3', 'Successful reperfusion', 'symptomatic intracranial hemorrhage', 'score of 0 to 3 on the modified Rankin Scale', 'reperfusion status and symptomatic intracranial hemorrhage']","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",264.0,0.108193,"Favorable outcome (modified Rankin Scale score 0-3) was observed in 115/252 (46%) patients, and 109/252 (43%) patients died.","[{'ForeName': 'F Anne V', 'Initials': 'FAV', 'LastName': 'Pirson', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, School for Cardiovascular Diseases (CARIM), the Netherlands (F.A.V.P., R.-J.B.G., J.S., R.J.v.O.).'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Boodt', 'Affiliation': 'Department of Neurology (N.B., S.J.d.H., D.W.J.D.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Josje', 'Initials': 'J', 'LastName': 'Brouwer', 'Affiliation': 'Department of Neurology (J.B., J.M.C.), Amsterdam University Medical Center, location AMC, the Netherlands.'}, {'ForeName': 'Agnetha A E', 'Initials': 'AAE', 'LastName': 'Bruggeman', 'Affiliation': 'Department of Radiology and Nuclear Medicine (A.A.E.B., C.B.L.M.M., B.J.E.), Amsterdam University Medical Center, location AMC, the Netherlands.'}, {'ForeName': 'Sanne J', 'Initials': 'SJ', 'LastName': 'den Hartog', 'Affiliation': 'Department of Neurology (N.B., S.J.d.H., D.W.J.D.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Robert-Jan B', 'Initials': 'RB', 'LastName': 'Goldhoorn', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, School for Cardiovascular Diseases (CARIM), the Netherlands (F.A.V.P., R.-J.B.G., J.S., R.J.v.O.).'}, {'ForeName': 'Lucianne C M', 'Initials': 'LCM', 'LastName': 'Langezaal', 'Affiliation': 'Department of Radiology, Sint Antonius Hospital, Nieuwegein, the Netherlands (L.C.M.L., J.-A.V.).'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Staals', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, School for Cardiovascular Diseases (CARIM), the Netherlands (F.A.V.P., R.-J.B.G., J.S., R.J.v.O.).'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Zwam', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center, CARIM, the Netherlands (W.H.v.Z., C.v.d.L., R.J.B.B.).'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'van der Leij', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center, CARIM, the Netherlands (W.H.v.Z., C.v.d.L., R.J.B.B.).'}, {'ForeName': 'Rutger J B', 'Initials': 'RJB', 'LastName': 'Brans', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center, CARIM, the Netherlands (W.H.v.Z., C.v.d.L., R.J.B.B.).'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology and Nuclear Medicine (A.A.E.B., C.B.L.M.M., B.J.E.), Amsterdam University Medical Center, location AMC, the Netherlands.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'Department of Neurology (J.B., J.M.C.), Amsterdam University Medical Center, location AMC, the Netherlands.'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Emmer', 'Affiliation': 'Department of Radiology and Nuclear Medicine (A.A.E.B., C.B.L.M.M., B.J.E.), Amsterdam University Medical Center, location AMC, the Netherlands.'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': 'Department of Neurology (N.B., S.J.d.H., D.W.J.D.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Aad', 'Initials': 'A', 'LastName': 'van der Lugt', 'Affiliation': 'Department of Radiology and Nuclear Medicine (N.B., S.J.d.H., A.v.d.L.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Jan-Albert', 'Initials': 'JA', 'LastName': 'Vos', 'Affiliation': 'Department of Radiology, Sint Antonius Hospital, Nieuwegein, the Netherlands (L.C.M.L., J.-A.V.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'van Oostenbrugge', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, School for Cardiovascular Diseases (CARIM), the Netherlands (F.A.V.P., R.-J.B.G., J.S., R.J.v.O.).'}, {'ForeName': 'Wouter J', 'Initials': 'WJ', 'LastName': 'Schonewille', 'Affiliation': 'Department of Neurology, Sint Antonius Hospital, Nieuwegein, the Netherlands (W.J.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.121.034786']
1242,34757812,Quality of Life in Men With Prostate Cancer Randomly Allocated to Receive Docetaxel or Abiraterone in the STAMPEDE Trial.,"PURPOSE


Docetaxel and abiraterone acetate plus prednisone or prednisolone (AAP) both improve survival when commenced alongside standard of care (SOC) androgen deprivation therapy in locally advanced or metastatic hormone-sensitive prostate cancer. Thus, patient-reported quality of life (QOL) data may guide treatment choices.
METHODS


A group of patients within the STAMPEDE trial were contemporaneously enrolled with the possibility of being randomly allocated to receive either docetaxel + SOC or AAP + SOC. A mixed-model assessed QOL in those who had completed at least one QLQ-C30 + PR25 questionnaire. The primary outcome measure was difference in global-QOL (QLQ-C30 Q29&30) between patients allocated to docetaxel + SOC or AAP + SOC over the 2 years after random assignment, with a predefined criterion for clinically meaningful difference of > 4.0 points. Secondary outcome measures included longitudinal comparison of functional domains, pain, and fatigue, plus global-QOL at defined timepoints.
RESULTS


Five hundred fifteen patients (173 docetaxel + SOC and 342 AAP + SOC) were included. Baseline characteristics, proportion of missing data, and mean baseline global-QOL scores (docetaxel + SOC 77.8 and AAP + SOC 78.0) were similar. Over the 2 years following random assignment, the mean modeled global-QOL score was +3.9 points (95% CI, +0.5 to +7.2;  P  = .022) higher in patients allocated to AAP + SOC. Global-QOL was higher for patients allocated to AAP + SOC over the first year (+5.7 points, 95% CI, +3.0 to +8.5;  P  < .001), particularly at 12 (+7.0 points, 95% CI, +3.0 to +11.0;  P  = .001) and 24 weeks (+8.3 points, 95% CI, +4.0 to +12.6;  P  < .001).
CONCLUSION


Patient-reported QOL was superior for patients allocated to receive AAP + SOC, compared with docetaxel + SOC over a 2-year period, narrowly missing the predefined value for clinical significance. Patients receiving AAP + SOC reported clinically meaningful higher global-QOL scores throughout the first year following random assignment.",2021,"Global-QOL was higher for patients allocated to AAP + SOC over the first year (+5.7 points, 95% CI, +3.0 to +8.5;  P  < .001), particularly at 12 (+7.0 points, 95% CI, +3.0 to +11.0;  P  =","['A group of patients within the STAMPEDE trial were contemporaneously enrolled with the possibility', 'Men With Prostate Cancer', 'locally advanced or metastatic hormone-sensitive prostate cancer', 'Five hundred fifteen patients (173 docetaxel + SOC and 342 AAP + SOC) were included']","['care (SOC) androgen deprivation therapy', 'docetaxel + SOC', 'Docetaxel or Abiraterone', 'Docetaxel and abiraterone acetate plus prednisone or prednisolone (AAP', 'AAP + SOC', 'docetaxel + SOC or AAP + SOC']","['global-QOL (QLQ-C30 Q29&30', 'Baseline characteristics, proportion of missing data, and mean baseline global-QOL scores', 'Global-QOL', 'Quality of Life', 'longitudinal comparison of functional domains, pain, and fatigue, plus global-QOL at defined timepoints', 'global-QOL scores', 'mean modeled global-QOL score']","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",515.0,0.158899,"Global-QOL was higher for patients allocated to AAP + SOC over the first year (+5.7 points, 95% CI, +3.0 to +8.5;  P  < .001), particularly at 12 (+7.0 points, 95% CI, +3.0 to +11.0;  P  =","[{'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Rush', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Murphy', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Alicia K', 'Initials': 'AK', 'LastName': 'Morgans', 'Affiliation': 'Northwestern University, Chicago, IL.'}, {'ForeName': 'Noel W', 'Initials': 'NW', 'LastName': 'Clarke', 'Affiliation': 'The Christie and Salford Royal NHS Foundation Trusts, Manchester, United Kingdom.'}, {'ForeName': 'Adrian D', 'Initials': 'AD', 'LastName': 'Cook', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'UCL Cancer Institute, London, United Kingdom.'}, {'ForeName': 'Archie', 'Initials': 'A', 'LastName': 'Macnair', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Parker', 'Affiliation': 'Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'J Martin', 'Initials': 'JM', 'LastName': 'Russell', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Gillessen', 'Affiliation': 'Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Matheson', 'Affiliation': 'University of Wolverhampton, Wolverhampton, United Kingdom.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Millman', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Brawley', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Pugh', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Jacob S', 'Initials': 'JS', 'LastName': 'Tanguay', 'Affiliation': 'Velindre Cancer Centre, Cardiff, Wales.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Jones', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wagstaff', 'Affiliation': 'Velindre Cancer Centre, Cardiff, Wales.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rudman', 'Affiliation': ""Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Joe M', 'Initials': 'JM', 'LastName': ""O'Sullivan"", 'Affiliation': ""Patrick G. Johnston Centre for Cancer Research, Queen's University Belfast, United Kingdom.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Gale', 'Affiliation': 'Portsmouth Hospital University Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Rosemere Cancer Centre, Lancs Teaching Hospitals, Preston, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Protheroe', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Gray', 'Affiliation': 'Musgrove Park Hospital, Taunton, United Kingdom.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Perna', 'Affiliation': 'Royal Surrey Hospital Foundation Trust, Guildford, United Kingdom.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Tolan', 'Affiliation': 'The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'McPhail', 'Affiliation': 'Raigmore Hospital, Inverness, Scotland.'}, {'ForeName': 'Zaf I', 'Initials': 'ZI', 'LastName': 'Malik', 'Affiliation': 'The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, United Kingdom.'}, {'ForeName': 'Salil', 'Initials': 'S', 'LastName': 'Vengalil', 'Affiliation': 'University Hospital North Midlands NHS Trust, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fackrell', 'Affiliation': 'University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hoskin', 'Affiliation': 'University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Duncan C', 'Initials': 'DC', 'LastName': 'Gilbert', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Mahesh K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Langley', 'Affiliation': 'MRC Clinical Trials Units at University College London, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.00728']
1243,34762989,Superimposition of sequential scans to measure erosion on unpolished and curved human enamel.,"OBJECTIVES


To determine if superimposition of sequential scans can discriminate between different fluorides at step heights less than 5 μm on natural human enamel surfaces.
MATERIALS AND METHODS


Natural, unpolished, human enamel specimens (n = 60) were randomly assigned to one of three pre-treatment toothpaste slurries with a calcium silicate/fluoride, fluoride-only and a control. Baseline and post treatment scans, from a non-contacting profilometer with a 0.01 μm z-axis and <1 μm lateral scanning resolution were imported into superimposition software to define change in mean 3D step height and surface roughness following erosion in 0.3% citric acid for 15 min. Statistical analysis conducted with two-way repeated measures ANOVA and post-hoc Tukey's multiple comparisons.
RESULTS


Confidence and resolution of superimposition and subtraction of repeated profiles from unpolished enamel revealed accuracy within 1-2 μm. The technique was able to discriminate between the fluorides demonstrating statistical differences in mean (SD) 3D step height (μm) of 1.96 (0.40) and 2.75 (0.49) (p = 0.0024). There was a statistically significant increase in surface roughness for all groups after 15 min erosion compared to baseline. But no statistically significant difference between the interventions after 15 min erosion but there was compared to no fluoride (p = 0.006).
CONCLUSION


Superimposition and subtraction of profiles could discriminate between fluoride interventions, which showed statistical differences in enamel loss differences less than 3 μm.
CLINICAL SIGNIFICANCE


This erosion model and data analysis workflow was able to distinguish differences between scans of 3 μm on unpolished enamel following the interaction with fluoride.",2022,There was a statistically significant increase in surface roughness for all groups after 15 min erosion compared to baseline.,"['Natural, unpolished, human enamel specimens (n\u202f=\u202f60']","['toothpaste slurries with a calcium silicate/fluoride, fluoride-only and a control']",['surface roughness'],"[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}]",60.0,0.0925206,There was a statistically significant increase in surface roughness for all groups after 15 min erosion compared to baseline.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mylonas', 'Affiliation': ""School of Dentistry, College of Biomedical and Life Sciences, Cardiff University, Heath Park, Cardiff CF14 4XY, United Kingdom; Centre for Oral, Clinical &Translational Sciences, King's College London Faculty of Dentistry, Oral & Craniofacial Sciences, London, United Kingdom. Electronic address: mylonasp@cardiff.ac.uk.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Moazzez', 'Affiliation': ""Centre for Oral, Clinical &Translational Sciences, King's College London Faculty of Dentistry, Oral & Craniofacial Sciences, London, United Kingdom.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Joiner', 'Affiliation': 'Unilever Oral Care, Bebington, Wirral, United Kingdom.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bartlett', 'Affiliation': ""Centre for Oral, Clinical &Translational Sciences, King's College London Faculty of Dentistry, Oral & Craniofacial Sciences, London, United Kingdom.""}]",Journal of dentistry,['10.1016/j.jdent.2021.103879']
1244,34773725,"A single-blinded, randomized, controlled trial comparing efficacy between low-fluence alexandrite 755-nm picosecond laser and low-fluence neodymium-doped yttrium aluminum garnet (Nd:YAG) 1064-nm picosecond laser for the treatment of ultraviolet B-induced hyperpigmentation.","BACKGROUND


Hyperpigmentation is a common concern of patients in dermatology clinics. Although there are many treatment options, lasers are considered a promising therapy for various hyperpigmentary conditions.
OBJECTIVES


This study aims to evaluate the efficacy of alexandrite 755-nm picosecond and neodymium-doped yttrium aluminum garnet (Nd:YAG) 1064-nm picosecond lasers for the treatment of ultraviolet B (UVB)-induced hyperpigmentation in Asians.
MATERIALS AND METHODS


A randomized, single-blinded study was conducted. UVB-induced hyperpigmentation was performed in three spots by narrowband UVB. After 2 weeks, these three spots were allocated into 755-treated, 1064-treated, and control sites. Patients received weekly laser treatments for five sessions. Follow-ups were scheduled at 1 and 2 months after the last session.
RESULTS


Twenty patients attended the study. Overall, 755-nm and 1064-nm picosecond lasers showed a significant improvement in the mean lightness index (L*) compared to the control site, which started at Day 49 and Day 77, respectively. The mean L* of the 755-nm-treated site was also higher than that of the 1064-nm-treated site at Day 105 (p ≤ 0.001). Initially, the mean L*, physician's visual analog scale (VAS), and patient satisfaction with the 1064-nm picosecond laser were better than those with the 755-nm picosecond laser. Nevertheless, an inversion of the mean L* and VAS was noted at Day 49, whereas the mean patient satisfaction was noted at Day 77. In the subgroup analysis, a 755-nm picosecond laser effectively treated Fitzpatrick skin types (FPTs) III and IV. However, the mean L* of the 1064-nm picosecond laser was not significantly different from that of the control for FPT4.
CONCLUSION


The alexandrite 755-nm picosecond and Nd:YAG 1064-nm picosecond lasers appear to be effective and safe modalities for treating UVB-induced hyperpigmentation. With the setting employed in this study, the outcome after the 755-nm picosecond laser treatment seemed superior to that of the 1064-nm picosecond laser treatment, especially for FPT4.",2022,:YAG 1064-nm picosecond lasers appear to be effective and safe modalities for treating UVB-induced hyperpigmentation.,"['ultraviolet B (UVB)-induced hyperpigmentation in Asians', 'ultraviolet B-induced hyperpigmentation', 'Twenty patients attended the study', 'patients in dermatology clinics']","['alexandrite 755-nm picosecond and neodymium-doped yttrium aluminum garnet (Nd:YAG) 1064-nm picosecond lasers', 'low-fluence alexandrite 755-nm picosecond laser and low-fluence neodymium-doped yttrium aluminum garnet']","['mean lightness index (L', 'UVB-induced hyperpigmentation', ""mean L*, physician's visual analog scale (VAS), and patient satisfaction with the 1064-nm picosecond laser"", 'mean patient satisfaction', 'inversion of the mean L* and VAS']","[{'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3812390', 'cui_str': 'Dermatology clinic'}]","[{'cui': 'C0675767', 'cui_str': 'alexandrite'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C1532556', 'cui_str': 'Picosecond pulsed laser device'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1532556', 'cui_str': 'Picosecond pulsed laser device'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}]",,0.104584,:YAG 1064-nm picosecond lasers appear to be effective and safe modalities for treating UVB-induced hyperpigmentation.,"[{'ForeName': 'Vasanop', 'Initials': 'V', 'LastName': 'Vachiramon', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Amornrut', 'Initials': 'A', 'LastName': 'Namasondhi', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tanaporn', 'Initials': 'T', 'LastName': 'Anuntrangsee', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Natthachat', 'Initials': 'N', 'LastName': 'Jurairattanaporn', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14591']
1245,34775146,Umbilical Cord Blood or HLA-Haploidentical Transplantation: Real-World Outcomes versus Randomized Trial Outcomes.,"Randomized clinical trials offer the highest-quality data for modifying clinical practice. Results of a phase III randomized trial of nonmyeloablative transplantation for adults with high-risk hematologic malignancies with 2 umbilical cord blood (UCB) units (n = 183) or HLA-haploidentical relative bone marrow (Haplo-BM; n = 154) revealed a 2-year progression-free survival (PFS) of 41% after Haplo-BM transplantation and 35% after 2-unit UCB transplantation (P = .41), with overall survival (OS) of 57% and 46%, respectively (P = .04). We sought to examine the generalizability of BMT CTN 1101 to a contemporaneous cohort beyond the trial's prespecified 2-year outcomes. All transplantations were performed between June 2012 and June 2018 in the United States. We hypothesized that the results of a rigorous phase III randomized trial would be generalizable. Changes in graft selection for HLA-haploidentical relative transplantation during the trial period allowed comparison of outcomes after transplantation with Haplo-BM with those after haploidentical peripheral blood (Haplo-PB). The trial's broad eligibility criteria were applied to the data source of the Center for International Blood and Marrow Transplant Research to select nontrial subjects. Extended follow-up of trial subjects was obtained from this data source. Three separate analyses were performed: (1) trial subjects beyond the trial's 2-year endpoint; (2) comparison of trial subjects with a contemporaneous cohort of nontrial subjects (195 2-unit UCB, 358 Haplo-BM, and 403 Haplo-PB); and (3) comparison of nontrial subjects by donor and graft type. Multivariate analyses were performed using Cox proportional hazards models for comparison of outcomes by treatment groups. With longer follow-up of the trial cohorts, 5-year PFS (37% versus 29%; P = .08) and OS (42% versus 36%; P = .06) were not significantly different between the treatment groups. We then compared the trial results with outcomes of comparable real-world transplantations. Five-year OS did not differ between trial and nontrial 2-unit UCB transplantations (36% versus 41%; P = .48) or between trial and nontrial Haplo-BM transplantations (42% versus 47%; P = .80), confirming generalizability. The randomized trial did not accrue as planned and therefore lacked the statistical power to detect a 15% difference in PFS. With substantially larger numbers of nontrial Haplo-BM transplantations, 5-year survival was higher after nontrial Haplo-BM compared with trial 2-unit UCB (47% versus 36%; P = .012). Nontrial patients who underwent Haplo-PB transplantation had higher 5-year survival (54%) compared with trial Haplo-BM (hazard ratio [HR], 0.76; P = .044) and nontrial Haplo-BM (HR, 0.78; P = .026). Similarly, survival was better after Haplo-PB compared with trial UCB (HR, 0.57; P < .0001) and nontrial UCB (HR, 0.63; P = .0002). When considering alternative donor low-intensity conditioning regimen transplantation, a haploidentical relative is preferred, and PB is the preferred graft source.",2022,"Similarly, survival was higher after Haplo-PB compared to trial (HR 0.57, p<0.0001) and non-trial UCB (HR 0.63, p=0.0002).
","['adults with high- risk hematologic malignancies with two umbilical cord blood (UCB) units (n=183) or HLA-haploidentical relative bone marrow (Haplo-BM', ""Three separate analyses were performed: 1) trial subjects beyond the trial's 2-year endpoint 2) comparison of trial subjects to a contemporaneous cohort of non-trial subjects (195 two-unit UCB, 358 Haplo-BM, 403 Haplo-PB) and 3) comparison of non-trial subjects by donor and graft type""]","['non-myeloablative transplantation', 'Umbilical cord blood or HLA-haploidentical transplantation']","['2-year progression-free survival (PFS', '5-year survival', 'survival', 'overall survival', '5-year PFS', 'progression-free survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0018591', 'cui_str': 'Haplotypes'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C4505304', 'cui_str': 'Haploidentical Transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.206981,"Similarly, survival was higher after Haplo-PB compared to trial (HR 0.57, p<0.0001) and non-trial UCB (HR 0.63, p=0.0002).
","[{'ForeName': 'Paul V', 'Initials': 'PV', 'LastName': ""O'Donnell"", 'Affiliation': 'Hematopoietic Cell Transplant and Cell Therapy Program, Massachusetts General Hospital, Boston, Massachusetts. Electronic address: pvodonnell@mgh.harvard.edu.'}, {'ForeName': 'Claudio G', 'Initials': 'CG', 'LastName': 'Brunstein', 'Affiliation': 'Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Ephraim J', 'Initials': 'EJ', 'LastName': 'Fuchs', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Mei-Jie', 'Initials': 'MJ', 'LastName': 'Zhang', 'Affiliation': 'Division of Biostatistics, Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Allbee-Johnson', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': 'Department of Hematology/Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Leifer', 'Affiliation': 'Office of Biostatistics Research, National Heart Lung and Blood Institute, National Institutes of Health, Rockville, Maryland.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Elmariah', 'Affiliation': 'Department of Blood and Marrow Transplant and Cellular Immunotherapy, H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Grunwald', 'Affiliation': 'Department of Hematologic Oncology and Blood Disorders, Atrium Health Levine Cancer Center, Charlotte, North Carolina.'}, {'ForeName': 'Hamza', 'Initials': 'H', 'LastName': 'Hashmi', 'Affiliation': 'Division of Hematology Oncology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Magenau', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Majhail', 'Affiliation': 'Blood and Marrow Transplant Program, Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Milano', 'Affiliation': 'Adult Blood and Marrow Transplant Program, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Lawrence E', 'Initials': 'LE', 'LastName': 'Morris', 'Affiliation': 'Blood and Marrow Transplant Program, Blood and Marrow Transplant Group of Georgia, Northside Hospital, Atlanta, Georgia.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Rezvani', 'Affiliation': 'Division of Blood and Marrow Transplantation, Department of Medicine, Stanford University Medical Center, Stanford, California.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'McGuirk', 'Affiliation': 'Division of Hematology, University Kansas, Westwood, Kansas.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Jones', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Eapen', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.'}]",Transplantation and cellular therapy,['10.1016/j.jtct.2021.11.002']
1246,34775518,Oral bacterial decontamination using an innovative prototype for photocatalytic disinfection.,"OBJECTIVES


The aim of this study was to evaluate the effectiveness of a prototype photocatalytic device for bacterial decontaminations of the oral cavity.
METHODS


Sixty-four subjects (18-65) were selected and randomly assigned to eight groups (n = 8), according to oral disinfection protocol: (G1): distilled water (control); (G2): 1.5% hydrogen peroxide (HP); (G3): 3.0% HP; (G4): 0.12% chlorhexidine (CHX); (G5): Germinator; (G6): 1.5% HP + Germinator; (G7): 3.0%HP + Germinator; (G8): 0.12% CHX + Germinator. Stimulated saliva was collected before and after a 3-min mouthwash and/or Germinator application. The patients were kept relaxed and retained saliva 5-10 min, spitting out into the tube for 3 min. The percentage bacterial reduction was checked by counting the colony-forming units (CFUs) after culturing on blood agar plates. Data were subjected to one-way ANOVA followed by Tukey's post hoc test (α = 5%) for statistical significance.
RESULTS


The highest bacterial reduction was observed in groups 3 (3.0% HP), 6 (1.5% HP + Germinator), and 7 (3.0% + Germinator), with no statistically significant difference between them (p > 0.05). Groups 6 (1.5% HP + Germinator) and 8 (0.12% CHX + Germinator) showed higher bacterial reduction than groups 2 (1.5% HP) and 4 (0.12% CHX) (p < 0.05). Finally, group 5 (Germinator) showed higher bacterial reduction than control group (DW) and group 4 (0.12% CHX) (p < 0.05).
CONCLUSIONS


The photocatalytic disinfection was effective against oral bacteria and improved the antimicrobial action of 1.5% HP and 0.12%.
CLINICAL SIGNIFICANCE


The photocatalytic disinfection can be an alternative protocol to provide the oral decontamination.",2022,"The photocatalytic disinfection was effective against oral bacteria and improved the antimicrobial action of 1.5% HP and 0.12%.
",['Sixty-four subjects (18-65'],"['prototype photocatalytic device', 'oral disinfection protocol: (G1): distilled water (control); (G2): 1.5% hydrogen peroxide (HP); (G3): 3.0% HP; (G4): 0.12% chlorhexidine (CHX); (G5): Germinator; (G6): 1.5% HP\u2009+\u2009Germinator; (G7): 3.0%HP\u2009+\u2009Germinator; (G8): 0.12% CHX\u2009+\u2009Germinator']","['percentage bacterial reduction', 'bacterial reduction', 'highest bacterial reduction', 'antimicrobial action', 'Stimulated saliva']","[{'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0031180', 'cui_str': 'Peroxide'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}]",65.0,0.0515393,"The photocatalytic disinfection was effective against oral bacteria and improved the antimicrobial action of 1.5% HP and 0.12%.
","[{'ForeName': 'Matheus Albino', 'Initials': 'MA', 'LastName': 'Souza', 'Affiliation': 'School of Dentistry, University of Passo Fundo, Building A7, Suite 2, São JoséPasso Fundo, RS, 99052-900, Brazil. matheus292@yahoo.com.br.'}, {'ForeName': 'Daniela Jorge', 'Initials': 'DJ', 'LastName': 'Corralo', 'Affiliation': 'School of Dentistry, University of Passo Fundo, Building A7, Suite 2, São JoséPasso Fundo, RS, 99052-900, Brazil.'}, {'ForeName': 'Ezequiel Santin', 'Initials': 'ES', 'LastName': 'Gabrielli', 'Affiliation': 'School of Dentistry, University of Passo Fundo, Building A7, Suite 2, São JoséPasso Fundo, RS, 99052-900, Brazil.'}, {'ForeName': 'José Antônio Poli', 'Initials': 'JAP', 'LastName': 'Figueiredo', 'Affiliation': 'School of Dentistry, Federal University of Rio Grande Do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'School of Dentistry, University of the Pacific, San Francisco, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wolff', 'Affiliation': 'School of Dental Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Liviu', 'Initials': 'L', 'LastName': 'Steier', 'Affiliation': 'School of Dental Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",Clinical oral investigations,['10.1007/s00784-021-04282-z']
1247,34775960,Effects of electrical muscle stimulation on cerebral blood flow.,"BACKGROUND


Electrical muscle stimulation (EMS) induces involuntary muscle contraction. Several studies have suggested that EMS has the potential to be an alternative method of voluntary exercise; however, its effects on cerebral blood flow (CBF) when applied to large lower limb muscles are poorly understood. Thus, the purpose of this study was to examine the effects of EMS on CBF, focusing on whether the effects differ between the internal carotid (ICA) and vertebral (VA) arteries.
METHODS


The participants performed the experiments under EMS and control (rest) conditions in a randomized crossover design. The ICA and VA blood flow were measured before and during EMS or control. Heart rate, blood pressure, minute ventilation, oxygen uptake, and end-tidal partial pressure of carbon dioxide (P ET CO 2 ) were monitored and measured as well.
RESULTS


The ICA blood flow increased during EMS [Pre: 330 ± 69 mL min -1 ; EMS: 371 ± 81 mL min -1 , P = 0.001, effect size (Cohen's d) = 0.55]. In contrast, the VA blood flow did not change during EMS (Pre: 125 ± 47 mL min -1 ; EMS: 130 ± 45 mL min -1 , P = 0.26, effect size = 0.12). In the EMS condition, there was a significant positive linear correlation between ΔP ET CO 2  and ΔICA blood flow (R = 0.74, P = 0.02). No relationships were observed between ΔP ET CO 2  and ΔVA blood flow (linear: R = - 0.17, P = 0.66; quadratic: R = 0.43, P = 0.55).
CONCLUSIONS


The present results indicate that EMS increased ICA blood flow but not VA blood flow, suggesting that the effects of EMS on cerebral perfusion differ between anterior and posterior cerebral circulation, primarily due to the differences in cerebrovascular response to CO 2 .",2021,"In the EMS condition, there was a significant positive linear correlation between ΔP ET CO 2  and ΔICA blood flow (R = 0.74, P = 0.02).",['81'],"['Electrical muscle stimulation (EMS', 'EMS', 'electrical muscle stimulation']","['ΔICA blood flow', 'VA blood flow', 'ICA blood flow', 'Heart rate, blood pressure, minute ventilation, oxygen uptake, and end-tidal partial pressure of carbon dioxide (P ET CO 2 ', 'cerebral blood flow', 'ΔP ET CO 2  and ΔVA blood flow', 'cerebral blood flow (CBF', 'cerebrovascular response', 'ICA and VA blood flow']",[],"[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}]",,0.0178942,"In the EMS condition, there was a significant positive linear correlation between ΔP ET CO 2  and ΔICA blood flow (R = 0.74, P = 0.02).","[{'ForeName': 'Soichi', 'Initials': 'S', 'LastName': 'Ando', 'Affiliation': 'Graduate School of Informatics and Engineering, The University of Electro-Communications, 1-5-1 Chofugaoka, Chofu, Tokyo, 182-8585, Japan. soichi.ando@uec.ac.jp.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Takagi', 'Affiliation': 'Graduate School of Informatics and Engineering, The University of Electro-Communications, 1-5-1 Chofugaoka, Chofu, Tokyo, 182-8585, Japan.'}, {'ForeName': 'Hikaru', 'Initials': 'H', 'LastName': 'Watanabe', 'Affiliation': 'Faculty of Informatics and Engineering, The University of Electro-Communications, 1-5-1 Chofugaoka, Chofu, Tokyo, 182-8585, Japan.'}, {'ForeName': 'Kodai', 'Initials': 'K', 'LastName': 'Mochizuki', 'Affiliation': 'Graduate School of Informatics and Engineering, The University of Electro-Communications, 1-5-1 Chofugaoka, Chofu, Tokyo, 182-8585, Japan.'}, {'ForeName': 'Mizuki', 'Initials': 'M', 'LastName': 'Sudo', 'Affiliation': 'Physical Fitness Research Institute, Meiji Yasuda Life Foundation of Health and Welfare, Tobuki 150, Hachioji, Tokyo, 192-0001, Japan.'}, {'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Fujibayashi', 'Affiliation': 'Faculty of Agriculture, Setsunan University, Osaka, Japan.'}, {'ForeName': 'Shinobu', 'Initials': 'S', 'LastName': 'Tsurugano', 'Affiliation': 'Health Care Center, The University of Electro-Communication, 1-5-1 Chofugaoka, Chofu, Tokyo, 182-8585, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Department of Arts and Sport Science, Tokyo Gakugei University, Tokyo, Japan.'}]",BMC neuroscience,['10.1186/s12868-021-00670-z']
1248,34782191,"Neutrophil count, lymphocyte count and neutrophil-to-lymphocyte ratio in relation to response to adjunctive dexamethasone treatment in community-acquired pneumonia.","BACKGROUND


It is hypothesised that community-acquired pneumonia (CAP) patients with more severe disease or inflammation might benefit more from adjunctive corticosteroid treatment. Neutrophil count, lymphocyte count and neutrophil-lymphocyte ratio (NLR) have been associated with inflammation and disease severity in CAP. We investigated the interaction between these parameters and adjunctive dexamethasone effects on clinical outcomes in CAP.
METHODS


We conducted a post hoc analysis of the randomised placebo-controlled Santeon-CAP trial (n = 401), which showed a positive effect of adjunctive oral dexamethasone on length of stay (LOS) in CAP patients. White blood cell (WBC) count, neutrophil count, NLR (highest tertile vs. lowest two tertiles) and lymphocyte count (lowest tertile vs. highest two tertiles) were examined as potential effect modifiers of treatment with dexamethasone on LOS (primary outcome) and ICU-admission, 30-day mortality and hospital readmission.
RESULTS


WBC differential counts were available for 354 patients. The effect of dexamethasone on LOS was more pronounced in high WBC count, high neutrophil count or high NLR subgroups (difference in median LOS of 2 days versus zero days in the reference subgroups, p for interaction < 0.05). There was no effect modification for the other outcomes. Patients with low WBC and low neutrophil counts did not benefit from dexamethasone, while hospital readmission rate was higher in those treated with dexamethasone (6% vs. 11%).
CONCLUSIONS


WBC count and/or neutrophil might be easily available biomarkers to guide selection of CAP patients who are more likely to benefit from adjunctive dexamethasone treatment. Future prospective trials are needed to confirm this predictive potential.",2022,"Patients with low WBC and low neutrophil counts did not benefit from dexamethasone, while hospital readmission rate was higher in those treated with dexamethasone (6% vs. 11%).
","['CAP patients', 'community-acquired pneumonia (CAP) patients with more severe disease or inflammation', 'community-acquired pneumonia', '354 patients']","['placebo-controlled Santeon-CAP trial', 'dexamethasone', 'adjunctive oral dexamethasone']","['hospital readmission rate', 'Neutrophil count, lymphocyte count and neutrophil-to-lymphocyte ratio', 'low neutrophil counts', 'lymphocyte count', 'high WBC count, high neutrophil count', 'length of stay (LOS', 'ICU-admission, 30-day mortality and hospital readmission', 'Neutrophil count, lymphocyte count and neutrophil-lymphocyte ratio (NLR', 'White blood cell (WBC) count, neutrophil count, NLR']","[{'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0360528', 'cui_str': 'Dexamethasone-containing product in oral dose form'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0853697', 'cui_str': 'Neutropenia'}, {'cui': 'C0750426', 'cui_str': 'Increased blood leukocyte number'}, {'cui': 'C0151683', 'cui_str': 'Neutrophilia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.142798,"Patients with low WBC and low neutrophil counts did not benefit from dexamethasone, while hospital readmission rate was higher in those treated with dexamethasone (6% vs. 11%).
","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Wittermans', 'Affiliation': 'Department of Internal Medicine, St. Antonius Hospital, Koekoekslaan 1, 3435 CM Nieuwegein, the Netherlands; Department of Internal Medicine, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA Leiden, the Netherlands. Electronic address: e.wittermans@antoniusziekenhuis.nl.'}, {'ForeName': 'Ewoudt Mw', 'Initials': 'EM', 'LastName': 'van de Garde', 'Affiliation': 'Department of Clinical Pharmacy, St. Antonius Hospital, Koekoekslaan 1, 3435 CM Nieuwegein, the Netherlands; Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht , the Netherlands.'}, {'ForeName': 'G Paul', 'Initials': 'GP', 'LastName': 'Voorn', 'Affiliation': 'Department of Medical Microbiology and Immunology, St. Antonius Hospital, Koekoekslaan 1, 3435 CM Nieuwegein , the Netherlands.'}, {'ForeName': 'Arnoud F', 'Initials': 'AF', 'LastName': 'Aldenkamp', 'Affiliation': 'Department of Pulmonology, Catharina Hospital, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Janssen', 'Affiliation': 'Department of Pulmonology, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ Nijmegen, the Netherlands.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Grutters', 'Affiliation': 'Department of Pulmonology, St. Antonius Hospital, Koekoekslaan 1, 3435 CM Nieuwegein, the Netherlands; Division of Heart and Lungs, University Medical Centre Utrecht, Heidelberglaan 100, 3584 CX Utrecht , the Netherlands.'}, {'ForeName': 'Willem Jan W', 'Initials': 'WJW', 'LastName': 'Bos', 'Affiliation': 'Department of Internal Medicine, St. Antonius Hospital, Koekoekslaan 1, 3435 CM Nieuwegein, the Netherlands; Department of Internal Medicine, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA Leiden, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of internal medicine,['10.1016/j.ejim.2021.10.030']
1249,34785310,Effect of transcranial direct current stimulation in addition to visuomotor training on choice reaction time and cognition function in amateur soccer players (FAST trial): A randomized control trial.,"OBJECTIVES


This study aimed to evaluate the effect of anodal transcranial direct current stimulation (tDCS) over the dorsolateral prefrontal cortex (DLPFC) in addition to visuomotor training (VMT) on choice reaction time (CRT) and cognitive function in amateur soccer players.
DESIGN


Single-center, randomized, placebo-controlled, double-blind, parallel-group study.
SETTING


Neuroscience and Motor Control Laboratory.
PARTICIPANTS


Thirty Brazilian male amateur soccer players, aged 18-30 years.
MAIN OUTCOME MEASURES


Participants were allocated to the intervention or control groups. Both groups performed VMT, but the intervention group additionally underwent anodal tDCS over the left dorsolateral prefrontal cortex (DLPFC; F3). The cathodal electrode was positioned in the right supraorbital region (Fp2). The tDCS was applied at 2 mA for 20 min for five consecutive sessions (24 h intervals). The VMT protocol was delivered during the application of tDCS and was composed of kicking a ball for 10 min (between the fifth and fifteenth minutes of the 20 min of tDCS application). The primary outcome was assessed based on changes in CRT during reaching (non-trained limb) and kicking (trained limb) tasks. Secondary outcomes were overall cognitive function measured by the Trail Making Test part A (TMT-A) and part B (TMT-B), and Digit Span Test forward (DSF) and backward (DSB) scores. All outcomes were evaluated before and after the intervention.
RESULTS


In the primary outcomes, compared with the control group, the anodal tDCS combined with VMT group had greater reduction in CRT for the rectus femoris (p = 0.007) adjusted for age and baseline performance (F (1,26) = 22,23; p < 0,001) and for the triceps (p = 0.039) adjusted for training frequency (days/week) and baseline performance (F (1,26) = 5,70; p = 0,016). No differences were observed in the CRT of other muscles (anterior deltoid [p = 0.181], brachial biceps [p = 0.130], and vastus medialis [p = 0.074]). And, there were no differences between the groups in terms of cognitive function (TMT-A [p = 0.062]; TMT-B [p = 0.320]; DSF [p = 0.102]; DSB [p = 0.345]).
CONCLUSION


Anodal tDCS over the left DLPFC in addition to visuomotor training of a functional task can be an efficient tool for athletes to decrease the CRT of the rectus femoris (trained limb) and triceps (non-trained limb); however, there were no differences between the groups in the others muscles (anterior deltoid, brachial biceps, and vastus medialis), and in terms of cognitive function.",2022,"No differences were observed in the CRT of other muscles (anterior deltoid [p = 0.181], brachial biceps [p = 0.130], and vastus medialis [p = 0.074]).","['amateur soccer players', 'Thirty Brazilian male amateur soccer players, aged 18-30 years', 'amateur soccer players (FAST trial']","['visuomotor training', 'anodal transcranial direct current stimulation (tDCS', 'anodal tDCS', 'placebo', 'VMT', 'transcranial direct current stimulation', 'visuomotor training (VMT']","['brachial biceps', 'choice reaction time (CRT) and cognitive function', 'choice reaction time and cognition function', 'overall cognitive function measured by the Trail Making Test part A (TMT-A) and part B (TMT-B), and Digit Span Test forward (DSF) and backward (DSB) scores', 'cognitive function', 'changes in CRT during reaching (non-trained limb) and kicking (trained limb) tasks']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]",30.0,0.100765,"No differences were observed in the CRT of other muscles (anterior deltoid [p = 0.181], brachial biceps [p = 0.130], and vastus medialis [p = 0.074]).","[{'ForeName': 'Eduardo de Moura', 'Initials': 'EM', 'LastName': 'Neto', 'Affiliation': 'Master Student of Physical Education, Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Edilaine Aparecida', 'Initials': 'EA', 'LastName': 'da Silva', 'Affiliation': 'Master Student of Physical Education, Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Hélio Rubens de Carvalho', 'Initials': 'HRC', 'LastName': 'Nunes', 'Affiliation': 'Department of Public Health, Botucatu Medical School (UNESP), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Bazan', 'Affiliation': 'Department of Neurology, Psychology and Psychiatry, Botucatu Medical School (UNESP), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Luciane Aparecida Pascucci Sande', 'Initials': 'LAPS', 'LastName': 'de Souza', 'Affiliation': 'Department of Applied Physical Therapy, Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Gustavo José', 'Initials': 'GJ', 'LastName': 'Luvizutto', 'Affiliation': 'Department of Applied Physical Therapy, Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil. Electronic address: gluvizutto@gmail.com.'}]",Neuroscience letters,['10.1016/j.neulet.2021.136346']
1250,34786698,Using smartphone technology to improve prospective memory functioning: A randomized controlled trial.,"BACKGROUND


A decline in the ability to perform daily intentions-known as prospective memory-is a key driver of everyday functional impairment in dementia. In the absence of effective pharmacological treatments, there is a need for developing, testing, and optimizing behavioral interventions that can bolster daily prospective memory functioning. We investigated the feasibility and efficacy of smartphone-based strategies for prospective memory in persons with cognitive impairment.
METHODS


Fifty-two older adults (74.79 ± 7.20 years) meeting diagnostic criteria for mild cognitive impairment or mild dementia were enrolled in a 4-week randomized controlled trial. Participants were trained to use a digital voice recorder app or a reminder app to off-load prospective memory intentions. Prospective memory was assessed using experimenter-assigned tasks (e.g., call the laboratory on assigned days), standardized questionnaires, and structured interviews. Secondary dependent measures included days of phone and app usage, acceptability ratings, quality of life, and independent activities of daily living.
RESULTS


Participant ratings indicated that the intervention was acceptable and feasible. Furthermore, after the four-week intervention, participants reported improvements in daily prospective memory functioning on standardized questionnaires (p < 0.001, η p   2   = 0.285) and the structured interview (p < 0.001, d = 1.75). Participants performed relatively well on experimenter-assigned prospective memory tasks (51.7% ± 27.8%), with performance levels favoring the reminder app in Week 1, but reversing to favor the digital recorder app in Week 4 (p = 0.010, η p   2   = 0.079). Correlational analyses indicated that greater usage of the digital recorder or reminder app was associated with better prospective memory performance and greater improvements in instrumental activities of daily living (completed by care partners), even when controlling for condition, age, baseline cognitive functioning, and baseline smartphone experience.
CONCLUSIONS


Older adults with cognitive disorders can learn smartphone-based memory strategies and doing so benefits prospective memory functioning and independence.",2022,"Correlational analyses indicated that greater usage of the digital recorder or reminder app was associated with better prospective memory performance and greater improvements in instrumental activities of daily living (completed by care partners), even when controlling for condition, age, baseline cognitive functioning, and baseline smartphone experience.
","['Older adults with cognitive disorders', 'Fifty-two older adults (74.79\u2009±\u20097.20\u2009years) meeting diagnostic criteria for mild cognitive impairment or mild dementia', 'persons with cognitive impairment']","['smartphone technology', 'digital voice recorder app or a reminder app to off-load prospective memory intentions', 'smartphone-based strategies']","['days of phone and app usage, acceptability ratings, quality of life, and independent activities of daily living', 'instrumental activities of daily living', 'daily prospective memory functioning on standardized questionnaires']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0182913', 'cui_str': 'Recorder'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0589154', 'cui_str': 'Prospective memory'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0589154', 'cui_str': 'Prospective memory'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",52.0,0.0372336,"Correlational analyses indicated that greater usage of the digital recorder or reminder app was associated with better prospective memory performance and greater improvements in instrumental activities of daily living (completed by care partners), even when controlling for condition, age, baseline cognitive functioning, and baseline smartphone experience.
","[{'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Scullin', 'Affiliation': 'Department of Psychology and Neuroscience, Baylor University, Waco, Texas, USA.'}, {'ForeName': 'Winston E', 'Initials': 'WE', 'LastName': 'Jones', 'Affiliation': 'Department of Psychology and Neuroscience, Baylor University, Waco, Texas, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Phenis', 'Affiliation': 'Department of Neurology and Plummer Movement Disorders Center, Baylor Scott and White Health, Temple, Texas, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Beevers', 'Affiliation': 'Department of Neurology and Plummer Movement Disorders Center, Baylor Scott and White Health, Temple, Texas, USA.'}, {'ForeName': 'Sabra', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Department of Neurology and Plummer Movement Disorders Center, Baylor Scott and White Health, Temple, Texas, USA.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Dinh', 'Affiliation': 'Department of Neurology and Plummer Movement Disorders Center, Baylor Scott and White Health, Temple, Texas, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kiselica', 'Affiliation': 'Department of Health Psychology, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Jared F', 'Initials': 'JF', 'LastName': 'Benge', 'Affiliation': 'Department of Psychology and Neuroscience, Baylor University, Waco, Texas, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.17551']
1251,34786651,"Finerenone Dose-Exposure-Serum Potassium Response Analysis of FIDELIO-DKD Phase III: The Role of Dosing, Titration, and Inclusion Criteria.","BACKGROUND


Finerenone is a nonsteroidal selective mineralocorticoid receptor antagonist (MRA) that demonstrated efficacy in delaying the progression of chronic kidney disease (CKD) and reducing cardiovascular events in patients with CKD and type 2 diabetes mellitus in FIDELIO-DKD, where 5734 patients were randomized 1:1 to receive either finerenone or placebo, with a median follow-up of 2.6 years. Doses of finerenone 10 or 20 mg once daily were titrated based on (serum) potassium and estimated glomerular filtration rate. The MRA mode of action increases potassium.
METHODS


Nonlinear mixed-effects population pharmacokinetic/pharmacodynamic models were used to analyze the finerenone dose-exposure-response relationship for potassium in FIDELIO-DKD. Individual time-varying exposures from pharmacokinetic analyses were related to the potassium response via a maximal effect, indirect-response model informed by 148,384 serum potassium measurements.
RESULTS


Although observed potassium levels decreased with increasing dose (i.e., inverse relation), model-based simulations for a fixed-dose setting (i.e., no dose titration) revealed the intrinsic finerenone dose-exposure-potassium response, with potassium levels increasing in a dose- and exposure-dependent manner, thus explaining the apparent conflict. The potassium limit for inclusion and uptitration from finerenone 10 to 20 mg in FIDELIO-DKD was ≤ 4.8 mmol/L. Modified limits of ≤ 5.0 mmol/L were simulated, resulting in higher hyperkalemia frequencies for both the finerenone and the placebo arms, whereas the relative hyperkalemia risk of a finerenone treatment compared with placebo did not increase.
CONCLUSIONS


The analyses demonstrated the effectiveness of finerenone dose titration in managing serum potassium and provide a quantitative basis to guide safe clinical use.",2022,"Although observed potassium levels decreased with increasing dose (i.e., inverse relation), model-based simulations for a fixed-dose setting (i.e., no dose titration) revealed the intrinsic finerenone dose-exposure-potassium response, with potassium levels increasing in a dose- and exposure-dependent manner, thus explaining the apparent conflict.","['patients with CKD and type 2 diabetes mellitus in FIDELIO-DKD, where 5734 patients']","['finerenone or placebo', 'placebo', 'finerenone']","['potassium limit', 'potassium levels', 'relative hyperkalemia risk', 'hyperkalemia frequencies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C4045511', 'cui_str': 'finerenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",5734.0,0.0215875,"Although observed potassium levels decreased with increasing dose (i.e., inverse relation), model-based simulations for a fixed-dose setting (i.e., no dose titration) revealed the intrinsic finerenone dose-exposure-potassium response, with potassium levels increasing in a dose- and exposure-dependent manner, thus explaining the apparent conflict.","[{'ForeName': 'Sebastiaan Camiel', 'Initials': 'SC', 'LastName': 'Goulooze', 'Affiliation': 'Leiden Experts on Advanced Pharmacokinetics and Pharmacodynamics (LAP&P), Leiden, The Netherlands.'}, {'ForeName': 'Nelleke', 'Initials': 'N', 'LastName': 'Snelder', 'Affiliation': 'Leiden Experts on Advanced Pharmacokinetics and Pharmacodynamics (LAP&P), Leiden, The Netherlands.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Seelmann', 'Affiliation': 'Bayer AG, Pharmaceuticals R&D, Pharmacometrics, Leverkusen/Wuppertal/Berlin, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Horvat-Broecker', 'Affiliation': 'Bayer AG, Pharmaceuticals R&D, Pharmacovigilance, Wuppertal, Germany.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Brinker', 'Affiliation': 'Bayer AG, Pharmaceuticals R&D, Clinical Development, Wuppertal/Berlin, Germany.'}, {'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Joseph', 'Affiliation': 'Bayer AG, Pharmaceuticals R&D, Clinical Development, Wuppertal/Berlin, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Garmann', 'Affiliation': 'Bayer AG, Pharmaceuticals R&D, Pharmacometrics, Leverkusen/Wuppertal/Berlin, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Lippert', 'Affiliation': 'Bayer AG, Pharmaceuticals R&D, Pharmacometrics, Leverkusen/Wuppertal/Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissing', 'Affiliation': 'Bayer AG, Pharmaceuticals R&D, Pharmacometrics, Leverkusen/Wuppertal/Berlin, Germany. thomas.eissing@bayer.com.'}]",Clinical pharmacokinetics,['10.1007/s40262-021-01083-1']
1252,34756997,Ultrasound-Guided Subgluteal Sciatic Nerve Block for Pain Management during Endovascular Treatment for Below-the-Knee Arterial Occlusions.,"PURPOSE


To evaluate the ability of subgluteal sciatic nerve block (SSNB) to provide pain control during endovascular treatment of below-the-knee (BTK) occlusions.
MATERIALS AND METHODS


This randomized prospective controlled study evaluated 60 consecutive adult patients who underwent endovascular treatment for BTK occlusions. The patients were randomized into 2 equal groups; the SSNB group underwent SSNB in the subgluteal space under ultrasound guidance, while the control group received fentanyl as an analgesic. The visual analog scale (VAS) and Face, Legs, Activity, Cry, Consolability (FLACC) scale scores were recorded.
RESULTS


Compared with the control group, the SSNB group showed significantly lower median VAS (0 [range, 0-30] vs 70 [range, 20-100], P < .001) and median FLACC scale (0 [range, 0-2] vs 6 [range, 3-10], P < .001) scores. There was no statistically significant difference between the 2 groups regarding the remaining parameters. There was a very strong correlation between the VAS and FLACC scale scores in both the SSNB (r = 0.805, P < .001) and control (r = 0.950, P < .001) groups. The procedure time and total balloon inflation time correlated with the VAS (r = 0.411, P = .024, and r = 0.402, P = .031, respectively) and FLACC scale (r = 0.431, P = .017, and r = 0.414, P = .022, respectively) scores in the control group but not in the SSNB group (r = 0.364, P = .056, and r = 0.300, P =.085, respectively, for correlation with VAS score and r = 0.730, P = .068, and r = 0.704, P = .075, respectively, for correlation with the FLACC scale score).
CONCLUSIONS


SSNB is a highly effective and safe pain management modality for the endovascular treatment of BTK occlusions.",2022,There was no statistical difference between the two groups regarding remaining parameters.,['60 consecutive adult patients who underwent endovascular treatment for BTK occlusions'],"['Ultrasound-Guided Subgluteal Sciatic Nerve Block', 'fentanyl as an analgesic', 'SSNB group underwent SSNB', 'SSNB', 'subgluteal sciatic nerve block (SSNB']","['median VAS score', 'FLACC', 'VAS and FLACC scores', 'VAS score', 'visual analog scale (VAS) and Face, Legs, Activity, Cry, Consolability (FLACC) scale scores', 'Operation time and total balloon inflation time', 'median FLACC score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0230037', 'cui_str': 'Structure of center of face'}]",60.0,0.0220769,There was no statistical difference between the two groups regarding remaining parameters.,"[{'ForeName': 'Gurkan', 'Initials': 'G', 'LastName': 'Danisan', 'Affiliation': 'Department of Radiology, Sakarya University Faculty of Medicine, Sakarya, Turkey. Electronic address: gurkandanisan@yahoo.com.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Taydas', 'Affiliation': 'Department of Radiology, Sakarya University Faculty of Medicine, Sakarya, Turkey.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2021.10.018']
1253,34753425,Transmuscular quadratus lumborum block for postoperative pain and recovery after laparoscopic adrenalectomy: a randomized controlled trial.,"BACKGROUND


To investigate the role of transmuscular quadratus lumborum block (TMQLB) for postoperative pain control, patient satisfaction and recovery in laparoscopic adrenalectomy.
METHODS


Seventy-two patients aged between 18 and 70 years with an ASA I-II and scheduled for laparoscopic adrenalectomy were randomized to receive a single-shot TMQLB with 0.4 ml/kg 0.5 % ropivacaine or 0.4 ml/kg 0.9 % saline as placebo. The primary endpoint was pain on movement at 12 h after surgery evaluated by the numeric rating scale (NRS, 0-10). P-values < 0.05 was considered statistically significant. The secondary outcomes included pain at rest and pain on movement evaluated by the NRS, and postoperative recovery related parameters.
RESULTS


NRS on movement at 12 h after surgery was lower in the TMQLB group compared with the control (median 2 vs. 3, p = 0.024). Intraoperative fentanyl consumption was lower in the TMQLB group (247.08 ± 63.54 vs. 285.44 ± 74.70, p = 0.022). The rate of using postoperative rescue tramadol was also lower in the TMQLB group (5.6 vs. 27.8 %, p = 0.027). Similar incidences of nausea and vomiting were observed (11.1 vs. 25 %, p = 0.220). Patient satisfaction of pain service was better in the TMQLB group (83.3 vs. 25 %, p < 0.001) with shorter time to ambulation (16.5 vs. 21 h, p = 0.004) and flatus (18.5 vs. 23.5 h, p = 0.006).
CONCLUSIONS


TMQLB showed better control of postoperative pain on movement for laparoscopic adrenalectomy with improved patients' satisfaction of anesthesia, shorter time to ambulation and flatus.
TRIAL REGISTRATION


This study was registered at Clinicaltrials.gov ( NCT03942237 ; registration date: 08/05/2019; enrollment date: 10/05/2019).",2021,"Similar incidences of nausea and vomiting were observed (11.1 vs. 25 %, p = 0.220).",['Seventy-two patients aged between 18 and 70 years with an ASA I-II and scheduled for'],"['Transmuscular quadratus lumborum block', 'TMQLB', 'single-shot TMQLB with 0.4 ml/kg 0.5\u2009% ropivacaine or 0.4 ml/kg 0.9\u2009% saline as placebo', 'laparoscopic adrenalectomy', 'transmuscular quadratus lumborum block (TMQLB']","['pain on movement at 12\xa0h after surgery evaluated by the numeric rating scale', 'rate of using postoperative rescue tramadol', 'shorter time to ambulation', 'nausea and vomiting', 'pain at rest and pain on movement evaluated by the NRS, and postoperative recovery related parameters', 'Patient satisfaction of pain service', 'Intraoperative fentanyl consumption', 'flatus', 'satisfaction of anesthesia, shorter time to ambulation and flatus']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0521267', 'cui_str': 'Laparoscopic adrenalectomy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",72.0,0.689538,"Similar incidences of nausea and vomiting were observed (11.1 vs. 25 %, p = 0.220).","[{'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}, {'ForeName': 'Sufang', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}, {'ForeName': 'Xulei', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China. cuixulei10685@pumch.cn.'}, {'ForeName': 'Yuelun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Medical Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}, {'ForeName': 'Weigang', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Ji', 'Affiliation': 'Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100730, Beijing, China.'}]",BMC anesthesiology,['10.1186/s12871-021-01494-4']
1254,34753423,"Supraclavicular block with Mepivacaine vs Ropivacaine, their impact on postoperative pain: a prospective randomised study.","BACKGROUND


Supraclavicular block (SCB) with long-acting local anaesthetic is commonly used for surgical repair of distal radial fractures (DRF). Studies have shown a risk for rebound pain when the block fades. This randomised single-centre study aimed to compare pain and opioid consumption the first three days post-surgery between SCB-mepivacaine vs. SCB-ropivacaine, with general anaesthesia (GA) as control.
METHODS


Patients (n = 90) with ASA physical status 1-3 were prospectively randomised to receive; SCB with mepivacine 1%, 25-30 ml (n = 30), SCB with ropivacaine 0.5%, 25-30 ml (n = 30) or GA (n = 30) with propofol/fentanyl/sevoflurane. Study objectives compared postoperative pain with Numeric Rating Scale (NRS) and sum postoperative Opioid Equivalent Consumption (OEC) during the first 3 days post-surgery between study-groups.
RESULTS


The three groups showed significant differences in postoperative pain-profile. Mean NRS at 24 h was significantly lower for the SCB-mepivacaine group (p = 0.018). Further both median NRS and median OEC day 0 to 3 were significanly lower in the SCB-mepivacaine group as compared to the SCB-ropivacaine group during the first three days after surgery; pain NRS 1 (IQR 0.3-3.3) and 2.7 (IQR 1.3-4.2) (p = 0.017) and OEC 30 mg (IQR 10-80) and 85 mg (IQR 45-125) (p = 0.004), respectively. The GA-group was in between both in pain NRS and median sum OEC. Unplanned healthcare contacts were highest among SCB-ropivacaine patients (39.3%) vs. SCB-mepivacaine patients (0%) and GA-patients (3.4%).
CONCLUSIONS


The potential benefit of longer duration of analgesia, associated to a long-acting local anaesthetic agent, during the early postoperative course must be put in perspective of potential worse pain progression following block resolution.
TRIAL REGISTRATION


NCT03749174 (clinicaltrials.gov, Nov 21, 2018, retrospectively registered).",2021,Mean NRS at 24 h was significantly lower for the SCB-mepivacaine group (p = 0.018).,['Patients (n\u2009=\u200990) with ASA physical status 1-3'],"['Mepivacaine vs Ropivacaine', 'SCB-mepivacaine vs. SCB-ropivacaine, with general anaesthesia (GA', 'SCB with mepivacine', 'propofol/fentanyl/sevoflurane', 'SCB-mepivacaine', 'SCB-ropivacaine', 'SCB with ropivacaine 0.5%, 25-30\u2009ml (n\u2009=\u200930) or GA', 'mepivacaine']","['postoperative pain with Numeric Rating Scale (NRS) and sum postoperative Opioid Equivalent Consumption (OEC', 'postoperative pain-profile', 'pain and opioid consumption', 'Unplanned healthcare contacts', 'median NRS and median OEC', 'postoperative pain', 'Mean NRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.38452,Mean NRS at 24 h was significantly lower for the SCB-mepivacaine group (p = 0.018).,"[{'ForeName': 'Irén', 'Initials': 'I', 'LastName': 'Sellbrant', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden. iren.sellbrant@vgregion.se.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Karlsson', 'Affiliation': 'Department of Orthopedic Surgery, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Jakobsson', 'Affiliation': 'Department of Anaesthesia & Intensive Care, Institute of Clinical Science, Karolinska Institute, Danderyd University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Nellgård', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",BMC anesthesiology,['10.1186/s12871-021-01499-z']
1255,34754306,Attention Bias to Pain Words Comes Early and Cognitive Load Matters: Evidence from an ERP Study on Experimental Pain.,"Attention bias (AB) is a common cognitive challenge for patients with pain. In this study, we tested at what stage AB to pain occurs in participants with experimental pain (EP) and tested whether cognitive load interferes with it. We recruited 40 healthy adults aged 18-27 years, and randomized them into control and EP groups. We sprayed the participants in the EP group with 10% capsaicin paste to mimic acute pain and those in the control group with water, accessing both groups' behavioral results and event-related potential data. We found that high-load tasks had longer response times and lower accuracies than low-load tasks did and that different neural processing of words occurred between the groups. The EP group exhibited AB to pain at an early stage with both attentional avoidance (N1 latency) and facilitated attention (P2 amplitude) to pain words. The control group coped with semantic differentiation (N1) at first, followed by pain word discrimination (P2). In addition, AB to pain occurred only in low-load tasks. As the cognitive load multiplied, we did not find AB in the EP group. Therefore, our study adds further evidence for AB to pain, suggesting the implementation of cognitive load in future AB therapy.",2021,The EP group exhibited AB to pain at an early stage with both attentional avoidance (N1 latency) and facilitated attention (P2 amplitude) to pain words.,"['participants with experimental pain (EP', '40 healthy adults aged 18-27 years', 'patients with pain']",['capsaicin paste'],['AB to pain'],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",40.0,0.104828,The EP group exhibited AB to pain at an early stage with both attentional avoidance (N1 latency) and facilitated attention (P2 amplitude) to pain words.,"[{'ForeName': 'Kangling', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Shimin', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Howe', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Physical Therapy, Health Science Center, University of North Texas, Fort Worth, TX, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}]",Neural plasticity,['10.1155/2021/9940889']
1256,34755519,Benefit-Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER.,"Background Thromboprophylaxis extended after hospital discharge in medically ill patients currently is not recommended by practice guidelines because of uncertainty about the benefit for preventing major or fatal thromboembolic events, and the risk of bleeding. Methods and Results We assessed the benefit and risk of thromboprophylaxis with rivaroxaban 10 mg once daily extended for 25 to 45 days after hospitalization for preventing major thromboembolism in medically ill patients using the pooled data in 16 496 patients from 2 randomized trials, MARINER (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk) and MAGELLAN (Multicenter, randomized, parallel-group efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically ill patients comparing rivaroxaban with enoxaparin). The data from the MARINER trial were pooled with the data from the MAGELLAN trial in patients who were free of thrombotic or bleeding events up to the last dose of enoxaparin/placebo and who continued in the outpatient phase of thromboprophylaxis. The composite outcome of major thromboembolic events (symptomatic deep vein thrombosis, nonfatal pulmonary embolism, myocardial infarction, and nonhemorrhagic stroke) and all-cause mortality was used to assess benefit and was compared with the risk of the composite of fatal and critical site bleeding. The incidence of the composite efficacy outcome was 1.80% (148 of 8222 patients) in the rivaroxaban group, compared with 2.31% (191 of 8274 patients in the placebo group) (HR, 0.78 [95% CI, 0.63-0.97],  P =0.024). Fatal or critical site bleeding events were infrequent and occurred in <0.1% of patients in both groups (rivaroxaban 0.09%; placebo 0.04%; HR, 2.36;  P =0.214). Conclusions The results suggest a benefit for reducing major thromboembolic outcomes (number needed to treat: 197), with a favorable trade-off to fatal or critical site bleeding (number needed to harm: 2045). Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT00571649 and NCT02111564.",2021,"Fatal or critical site bleeding events were infrequent and occurred in <0.1% of patients in both groups (rivaroxaban 0.09%; placebo 0.04%; HR, 2.36;  P =0.214).","['hospitalized medically ill patients comparing', 'medically ill patients using the pooled data in 16\xa0496 patients from 2 randomized trials, MARINER (Medically Ill Patient Assessment of', 'medically ill patients']","['rivaroxaban with enoxaparin', 'Rivaroxaban', 'rivaroxaban', 'enoxaparin/placebo', 'Rivaroxaban Versus Placebo']","['Fatal or critical site bleeding events', 'major thromboembolic events (symptomatic deep vein thrombosis, nonfatal pulmonary embolism, myocardial infarction, and nonhemorrhagic stroke) and all-cause mortality', 'incidence of the composite efficacy outcome', 'thrombotic or bleeding events', 'major thromboembolic outcomes', 'risk of the composite of fatal and critical site bleeding']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3805136', 'cui_str': 'Nonhaemorrhagic stroke'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",16496.0,0.460059,"Fatal or critical site bleeding events were infrequent and occurred in <0.1% of patients in both groups (rivaroxaban 0.09%; placebo 0.04%; HR, 2.36;  P =0.214).","[{'ForeName': 'Gary E', 'Initials': 'GE', 'LastName': 'Raskob', 'Affiliation': 'Hudson College of Public HealthUniversity of Oklahoma Health Sciences Center Oklahoma City OK.'}, {'ForeName': 'Alex C', 'Initials': 'AC', 'LastName': 'Spyropoulos', 'Affiliation': 'Department of Medicine, Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill HospitalThe Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, The Feinstein Institute for Medical Research New York NY.'}, {'ForeName': 'Theodore E', 'Initials': 'TE', 'LastName': 'Spiro', 'Affiliation': 'Thrombosis and Hematology Therapeutic Area Clinical Development Pharmaceuticals Bayer U.S. LLC Whippany NJ.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Janssen Research and Development LLC Raritan NJ.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Janssen Research and Development LLC Titusville NJ.'}, {'ForeName': 'Bennett', 'Initials': 'B', 'LastName': 'Levitan', 'Affiliation': 'Janssen Research and Development LLC Titusville NJ.'}, {'ForeName': 'Eunyoung', 'Initials': 'E', 'LastName': 'Suh', 'Affiliation': 'Janssen Research and Development LLC Raritan NJ.'}, {'ForeName': 'Elliot S', 'Initials': 'ES', 'LastName': 'Barnathan', 'Affiliation': 'Janssen Research and Development LLC Raritan NJ.'}]",Journal of the American Heart Association,['10.1161/JAHA.121.021579']
1257,34757989,"A Peer-Led, Artificial Intelligence-Augmented Social Network Intervention to Prevent HIV Among Youth Experiencing Homelessness.","BACKGROUND


Youth experiencing homelessness (YEH) are at elevated risk of HIV/AIDS and disproportionately identify as racial, ethnic, sexual, and gender minorities. We developed a new peer change agent (PCA) HIV prevention intervention with 3 arms: (1) an arm using an artificial intelligence (AI) planning algorithm to select PCAs; (2) a popularity arm, the standard PCA approach, operationalized as highest degree centrality (DC); and (3) an observation-only comparison group.
SETTING


A total of 713 YEH were recruited from 3 drop-in centers in Los Angeles, CA.
METHODS


Youth consented and completed a baseline survey that collected self-reported data on HIV knowledge, condom use, and social network information. A quasi-experimental pretest/posttest design was used; 472 youth (66.5% retention at 1 month postbaseline) and 415 youth (58.5% retention at 3 months postbaseline) completed follow-up. In each intervention arm (AI and DC), 20% of youth was selected as PCAs and attended a 4-hour initial training, followed by 7 weeks of half-hour follow-up sessions. Youth disseminated messages promoting HIV knowledge and condom use.
RESULTS


Using generalized estimating equation models, there was a significant reduction over time (P < 0.001) and a significant time by AI arm interaction (P < 0.001) for condomless anal sex act. There was a significant increase in HIV knowledge over time among PCAs in DC and AI arms.
CONCLUSIONS


PCA models that promote HIV knowledge and condom use are efficacious for YEH. Youth are able to serve as a bridge between interventionists and their community. Interventionists should consider working with computer scientists to solve implementation problems.",2021,"Using generalized estimating equation models, there was a significant reduction over time (P < 0.001) and a significant time by AI arm interaction (P < 0.001) for condomless anal sex act.","['Youth consented and completed a baseline survey that collected self-reported data on HIV knowledge, condom use, and social network information', 'Youth Experiencing Homelessness', '472 youth (66.5% retention at 1 month postbaseline) and 415 youth (58.5% retention at 3 months postbaseline) completed follow-up', 'A total of 713 YEH were recruited from 3 drop-in centers in Los Angeles, CA', 'Youth experiencing homelessness (YEH']","['Artificial Intelligence-Augmented Social Network Intervention to Prevent HIV', 'new peer change agent (PCA) HIV prevention intervention with 3 arms: (1) an arm using an artificial intelligence (AI) planning algorithm to select PCAs']",['HIV knowledge'],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",713.0,0.0221156,"Using generalized estimating equation models, there was a significant reduction over time (P < 0.001) and a significant time by AI arm interaction (P < 0.001) for condomless anal sex act.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rice', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work and Center for Artificial Intelligence in Society, University of Southern California Los Angeles, CA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Wilder', 'Affiliation': 'Center for Research on Computation and Society, John A. Paulson School of Engineering and Applied Sciences, Harvard University Cambridge, MA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Onasch-Vera', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work and Center for Artificial Intelligence in Society, University of Southern California Los Angeles, CA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'DiGuiseppi', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work and Center for Artificial Intelligence in Society, University of Southern California Los Angeles, CA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Petering', 'Affiliation': 'Lens Co.'}, {'ForeName': 'Chyna', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work and Center for Artificial Intelligence in Society, University of Southern California Los Angeles, CA.'}, {'ForeName': 'Amulya', 'Initials': 'A', 'LastName': 'Yadav', 'Affiliation': 'College of Information Sciences and Technology, Pennsylvania State University College Station, TX; and.'}, {'ForeName': 'Sung-Jae', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Division of Population Behavioral Health, David Geffen School of Medicine, University of California, Los Angeles Los Angeles, CA.'}, {'ForeName': 'Milind', 'Initials': 'M', 'LastName': 'Tambe', 'Affiliation': 'Center for Research on Computation and Society, John A. Paulson School of Engineering and Applied Sciences, Harvard University Cambridge, MA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002807']
1258,34762845,Multicomponent Staff Training Intervention to Improve Residential Dementia Care (PROCUIDA-Demencia): A Mixed-Methods 2-Arm Cluster Randomized Controlled Pilot and Clinical Outcomes Study.,"OBJECTIVES


To evaluate the feasibility outcomes of implementing a multicomponent staff training intervention (PROCUIDA-Demencia) to promote psychosocial interventions and reduce antipsychotic prescription in Mexican care homes and study its effect on staff's care experience and residents' quality of life.
DESIGN


A mixed-methods 2-arm cluster randomized controlled pilot study of a 2-day staff training program with baseline, 12 weeks, and 24 weeks of the PROCUIDA-Demencia intervention vs treatment as usual (TAU).
SETTING AND PARTICIPANTS


Eight care homes in Mexico City were selected, from which 55 residents and 126 staff were recruited.
INTERVENTION


In situ staff training consisting of evidence-based manualized psychosocial interventions of person-centered activities, reminiscence therapy, doll therapy, psychomotor dance therapy, and antipsychotic prescription review. Fidelity to protocol was supervised once a week.
METHODS


Cluster-level feasibility measures included views of staff, residents, and relatives on acceptability, satisfaction, adherence, and fidelity to the intervention. Staff outcome measures were Maslach Burnout Inventory (MBI), Approaches to Dementia Questionnaire, and Sense of Competence in Dementia Care Staff. Residents' outcome measures included Quality of Life-Alzheimer's Disease scale (QoL-AD), and Neuropsychiatric Inventory-Nursing Home Version (NPI-NH). Staff distress was measured using the NPI-NH occupational disturbance scale. Feasibility was elicited through a focus group, and hierarchical linear mixed effects models were used to assess the adjusted effects of the respective measures.
RESULTS


Observed medical practice showed the prescription of at least 1 antipsychotic in 41% of participants in the intervention group. Overall, 39% of residents reported discontinuation, and 15% reduction of antipsychotics, following the 12-week medical review in parallel with psychosocial interventions. Clinical outcomes contributed positively to the reduction in baseline staff burden according to the MBI after the intervention [mean difference -8.9, 95% confidence interval (CI) -17.7, -0.1, P = .049] and to the reduction in severity and frequency of behavior as per NPI-NH in residents (mean difference -9.4, 95% CI -17.5, -1.3, P = .025).
CONCLUSIONS AND IMPLICATIONS


PROCUIDA-Demencia is a feasible intervention for Mexican care homes. Results contribute to the Mexican Dementia Plan optimizing dementia care by supporting the need for staff training to implement psychosocial interventions prior to prescribing antipsychotic medication.",2022,"Overall, 39% of residents reported discontinuation, and 15% reduction of antipsychotics, following the 12-week medical review in parallel with psychosocial interventions.","['Residential Dementia Care (PROCUIDA-Demencia', 'Eight care homes in Mexico City were selected, from which 55 residents and 126 staff were recruited', 'Mexican care homes']","['Multicomponent Staff Training Intervention', 'multicomponent staff training intervention']","[""Quality of Life-Alzheimer's Disease scale (QoL-AD), and Neuropsychiatric Inventory-Nursing Home Version (NPI-NH"", 'Maslach Burnout Inventory (MBI), Approaches to Dementia Questionnaire, and Sense of Competence in Dementia Care Staff', 'severity and frequency of behavior', 'NPI-NH occupational disturbance scale', 'Staff distress', 'acceptability, satisfaction, adherence, and fidelity to the intervention']","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]","[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0790856,"Overall, 39% of residents reported discontinuation, and 15% reduction of antipsychotics, following the 12-week medical review in parallel with psychosocial interventions.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Torres-Castro', 'Affiliation': 'Instituto Nacional de Geriatría, San Jerónimo Lídice, Mexico City, Mexico. Electronic address: storres@inger.gob.mx.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Rabaneda-Bueno', 'Affiliation': 'Biology Centre of the Czech Academy of Sciences, Institute of Hydrobiology, České Budějovice, Czech Republic.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'López-Ortega', 'Affiliation': 'Instituto Nacional de Geriatría, San Jerónimo Lídice, Mexico City, Mexico.'}, {'ForeName': 'Luis Miguel', 'Initials': 'LM', 'LastName': 'Gutiérrez-Robledo', 'Affiliation': 'Instituto Nacional de Geriatría, San Jerónimo Lídice, Mexico City, Mexico.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'Guzmán', 'Affiliation': 'Department of Clinical Psychology, School of Health in Social Science, University of Edinburgh, Edinburgh, United Kingdom; Adult Mental Health Team Psychological Services, NHS Lothian, Royal Edinburgh Hospital, Edinburgh, United Kingdom.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2021.09.035']
1259,34767038,"The Singa-Pacli Trial, Another RCT that Lacks to Encourage the use of DEB BTK.",,2021,,[],[],[],[],[],[],,0.0702522,,"[{'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van Overhagen', 'Affiliation': 'Haga Teaching Hospital, Els Borst Eilersplein 275, 2545AA, Den Haag, The Netherlands. h.voverhagen@hagaziekenhuis.nl.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-021-02937-8']
1260,34773438,Reinforcing the effect of microsurgery practice during robotic suturing skill acquisition.,"BACKGROUND


This study aimed to examine the effectiveness of microsurgery practice during an interval in robotic surgical training.
METHODS


Two participant groups with 30 trainees each practiced Thread the Rings 1 on a dV-Trainer. There were four 2-h training sessions, with a 72-h interval between each session. Group A received no additional training during the study period. During every interval, Group B practiced a similar 2-h ring penetration exercise using a microscope three times (once every 24 h).
RESULTS


The 72-h delay between two sessions for Group A caused the forgetting effect. For Group B, additional microscope-based training aided memory retention. After the training session, Group B presented a significantly higher score than Group A in Thread the Ring 1 learning curves.
CONCLUSIONS


Adding microsurgical skill training into the basic robotic-surgery training curriculum could be helpful because additional trainings with a binocular microscope could improve robotic surgical skill levels.",2022,"After the training session, Group B presented a significantly higher score than Group A in Thread the Ring 1 learning curves.
",['Two participant groups with 30 trainees each practiced Thread the Rings 1 on a dV-Trainer'],[],"['robotic surgical skill levels', 'forgetting effect']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}]",[],"[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.019095,"After the training session, Group B presented a significantly higher score than Group A in Thread the Ring 1 learning curves.
","[{'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Zhongnan Hospital, Wuhan University, Wuhan, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Zhongnan Hospital, Wuhan University, Wuhan, China.'}, {'ForeName': 'Xinghuan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Zhongnan Hospital, Wuhan University, Wuhan, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Lei', 'Affiliation': 'Zhongnan Hospital, Wuhan University, Wuhan, China.'}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Zhongnan Hospital, Wuhan University, Wuhan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Zhongnan Hospital, Wuhan University, Wuhan, China.'}]",The international journal of medical robotics + computer assisted surgery : MRCAS,['10.1002/rcs.2350']
1261,34775069,"Adding six short lines on pulmonary vein isolation circumferences reduces recurrence of paroxysmal atrial fibrillation: Results from a multicenter, single-blind, randomized trial.","BACKGROUND


Pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF) is associated with a non-negligible long-term recurrence rate.
OBJECTIVES


The purpose of this study was to investigate whether PVI combined with 6 short ablation lines on the PVI circumferences (PVI+6L group) yields higher success rates than PVI alone (PVI group).
METHODS


In this multicenter, single-blind, randomized trial, a total of 390 patients with paroxysmal AF were randomly assigned to the PVI group (n = 193) or the PVI+6L group (n = 197). The primary endpoint was freedom from AF/atrial tachycardia recurrence between 91 and 365 days. Secondary endpoints included AF burden, procedural parameters, and complications.
RESULTS


Freedom from atrial tachyarrhythmia was achieved in 160 of 197 patients (81.2%) in the PVI+6L group and 142 of 193 patients (73.6%) in the PVI group (hazard ratio 0.61; 95% confidence interval 0.39-0.97; P = .040). Mean AF burden tended to be lower in the PVI+6L group compared to the PVI group (1.95% vs 0.53%, P = .097). Procedural and ablation times were slightly longer in the PVI+6L group than in the PVI group (130 ± 25 minutes vs 121 ± 28 minutes; P = .002; and 46 ± 14 minutes vs 41 ± 16 minutes, P = .001, respectively). X-ray exposure was similar (60 ± 54 seconds vs 61 ± 60 seconds; P = .964). Complications occurred in 3 patients (1.6%) in the PVI group and 3 patients (1.5%) in the PVI+6L group.
CONCLUSION


In patients with paroxysmal AF undergoing catheter ablation, adding 6 short ablation lines on the PVI circumferences could reduce the AF recurrence rate.",2022,"Complications occurred in three patients (1.6%) in the PVI group and in three patients (1.5%) in the PVI+6L group.
","['patients with paroxysmal AF undergoing', '390 patients with paroxysmal AF']","['catheter ablation, adding six short ablation lines', 'PVI', 'PVI+6L', 'PVI combined with six short ablation lines', 'PVI alone (PVI group', 'Pulmonary vein isolation (PVI']","['Mean AF burden', 'AF burden, procedural parameters, and complications', 'Complications', 'recurrence rate of AF', 'freedom from AF/atrial tachycardia recurrence', 'Freedom from atrial tachyarrhythmia', 'Paroxysmal Atrial Fibrillation', 'Procedure and ablation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",390.0,0.0804518,"Complications occurred in three patients (1.6%) in the PVI group and in three patients (1.5%) in the PVI+6L group.
","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Mu', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qunshan', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Peng-Pai', 'Initials': 'PP', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Bin-Feng', 'Initials': 'BF', 'LastName': 'Mo', 'Affiliation': 'Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Xian-Jin', 'Initials': 'XJ', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': 'Department of Cardiology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China.'}, {'ForeName': 'Yizhang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China.'}, {'ForeName': 'Xingxing', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Tai-Zhong', 'Initials': 'TZ', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yi-Gang', 'Initials': 'YG', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. Electronic address: liyigang@xinhuamed.com.cn.'}]",Heart rhythm,['10.1016/j.hrthm.2021.11.014']
1262,34775065,Randomized controlled trial for evaluation of efficacy and pain during photodynamic therapy for actinic keratosis of face and scalp comparing two irradiation protocols.,"BACKGROUND


Pain is a frequent adverse event during photodynamic therapy, which can limit treatment acceptance. This study aimed to evaluate the efficacy and pain during photodynamic therapy with two irradiation protocols in patients with actinic keratosis on the face and scalp.
METHODS


In this intra-patient randomized controlled trial, participants were randomly allocated to receive photodynamic therapy with methyl aminolevulinate and red light on the right or left side with protocol 1 (irradiation device in contact with the skin) and protocol 2 (device 3 cm away from the skin). There was a 15-day interval between the protocols. The primary outcome was the frequency of mean intensity of moderate or severe pain during photodynamic therapy. Secondary outcomes were actinic keratosis clearance rate, protoporphyrin IX consumption, participant preference, skin appearance, and adverse events.
RESULTS


Forty-one participants were included, yielding 47 and 50 randomized sites for protocols 1 and 2. There was no difference in the frequency of moderate and severe pain, with a relative risk of 1.09 (95% CI 0.70-1.70), p>0.05. An actinic keratosis count reduction >60% was observed in both protocols (p<0.01), with no difference between them. There was no difference in protoporphyrin IX consumption. Most treated sites were of good to excellent quality. There was a greater patient preference for protocol 2 (p<0.01).
CONCLUSIONS


The pain intensity was similar between the protocols, and the protocols were equally effective for actinic keratosis clearance, protoporphyrin IX consumption, and improvement in the quality of the treated areas. Both protocols may be considered safe.",2022,"The pain intensity was similar between the protocols, and the protocols were equally effective for actinic keratosis clearance, protoporphyrin IX consumption, and improvement in the quality of the treated areas.","['patients with actinic keratosis on the face and scalp', 'Forty-one participants were included, yielding 47 and 50 randomized sites for protocols 1 and 2']",['photodynamic therapy with methyl aminolevulinate and red light on the right or left side with protocol 1 (irradiation device in contact with the skin) and protocol 2 (device 3 cm away from the skin'],"['efficacy and pain', 'actinic keratosis clearance rate, protoporphyrin IX consumption, participant preference, skin appearance, and adverse events', 'actinic keratosis count reduction', 'actinic keratosis clearance, protoporphyrin IX consumption', 'pain intensity', 'frequency of moderate and severe pain', 'protoporphyrin IX consumption', 'frequency of mean intensity of moderate or severe pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C1134467', 'cui_str': 'methyl 5-aminolevulinate'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0072497', 'cui_str': 'Protoporphyrin IX'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",41.0,0.143789,"The pain intensity was similar between the protocols, and the protocols were equally effective for actinic keratosis clearance, protoporphyrin IX consumption, and improvement in the quality of the treated areas.","[{'ForeName': 'Oliveira', 'Initials': 'O', 'LastName': 'Er', 'Affiliation': 'Skin Department of Amaral Carvalho Hospital, Jahu, SP, Brazil.'}, {'ForeName': 'Salvio', 'Initials': 'S', 'LastName': 'Ag', 'Affiliation': 'Skin Department of Amaral Carvalho Hospital, Jahu, SP, Brazil.'}, {'ForeName': 'Miot', 'Initials': 'M', 'LastName': 'Ha', 'Affiliation': 'Department of Infectology, Dermatology, Imaging Diagnosis and Radiotherapy, Botucatu Medical School (FMB), São Paulo State University (UNESP), Botucatu, SP, Brazil.'}, {'ForeName': 'Requena', 'Initials': 'R', 'LastName': 'Mb', 'Affiliation': 'Department of Infectology, Dermatology, Imaging Diagnosis and Radiotherapy, Botucatu Medical School (FMB), São Paulo State University (UNESP), Botucatu, SP, Brazil.'}, {'ForeName': 'Medeiros', 'Initials': 'M', 'LastName': 'Mmc', 'Affiliation': 'Skin Department of Amaral Carvalho Hospital, Jahu, SP, Brazil.'}, {'ForeName': 'Garcia', 'Initials': 'G', 'LastName': 'Mr', 'Affiliation': 'Sao Carlos Institute of Physics, University of Sao Paulo, São Carlos, SP, Brazil.'}, {'ForeName': 'Abbade', 'Initials': 'A', 'LastName': 'Lpf', 'Affiliation': 'Department of Infectology, Dermatology, Imaging Diagnosis and Radiotherapy, Botucatu Medical School (FMB), São Paulo State University (UNESP), Botucatu, SP, Brazil. Electronic address: fernandes.abbade@unesp.br.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102623']
1263,34775801,Therapeutic Plasma Exchange Protects Patients with Sepsis-Associated Disseminated Intravascular Coagulation by Improving Endothelial Function.,"The mortality rate of sepsis-associated disseminated intravascular coagulation (DIC) is high. This study aimed to explore the efficacy of therapeutic plasma exchange (TPE) in sepsis-associated DIC patients by improving endothelial function. A total of 112 sepsis-associated DIC patients were randomly divided into the TPE group (n = 40), the heparin (HP) group (n = 36), and the SHAM group (n = 36). The SHAM group received conventional treatment; the HP group was treated with HP based on conventional treatment; and the TPE group received conventional treatment plus TPE. The differences in thromboelastogram (TEG), platelet (PLT), coagulation function, and the endothelial cell (EC) injury biomarkers at 6 h, 24 h, 48 h, 72 h, and 7 days after TPE were compared among the three groups, and the three groups were compared in terms of Acute Physiology and Chronic Health Evaluation II (APACHE II) score, Sepsis-Related Organ Failure Assessment (SOFA) score, the length of intensive care unit (ICU) hospitalization, 28-day mortality rate, 28-day cumulative survival rate, the incidence of bleeding events, the incidence of acute kidney injury (AKI), and acute respiratory distress syndrome (ARDS). The efficacy of TPE is superior to the HP in increasing PLT, improving coagulation function, increasing the 28-day cumulative survival rate, and reducing the length of ICU hospitalization, 28-day mortality, and the incidence of bleeding events, AKI, and ARDS with statistically significant differences ( P   <  .05). Moreover, the effect of TPE outperforms HP on the EC injury biomarkers with statistically significant differences ( P   <  .05). Our results suggest that TPE may be more effective than HP in the treatment of patients with sepsis-associated DIC. The possible mechanism is via improving endothelial function.",2021,"Moreover, the effect of TPE outperforms HP on the EC injury biomarkers with statistically significant differences ( P   <  .05).","['112 sepsis-associated DIC patients', 'sepsis-associated DIC patients', 'patients with sepsis-associated DIC']","['SHAM', 'HP based on conventional treatment', 'TPE group received conventional treatment plus TPE', 'heparin (HP', 'TPE', 'therapeutic plasma exchange (TPE']","['Acute Physiology and Chronic Health Evaluation II (APACHE II) score, Sepsis-Related Organ Failure Assessment (SOFA) score, the length of intensive care unit (ICU) hospitalization, 28-day mortality rate, 28-day cumulative survival rate, the incidence of bleeding events, the incidence of acute kidney injury (AKI), and acute respiratory distress syndrome (ARDS', 'length of ICU hospitalization, 28-day mortality, and the incidence of bleeding events, AKI, and ARDS', 'coagulation function', '28-day cumulative survival rate', 'mortality rate of sepsis-associated disseminated intravascular coagulation (DIC', 'thromboelastogram (TEG), platelet (PLT), coagulation function, and the endothelial cell (EC) injury biomarkers']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0012739', 'cui_str': 'Disseminated intravascular coagulation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010456', 'cui_str': 'Cumulative Survival Rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0012739', 'cui_str': 'Disseminated intravascular coagulation'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",112.0,0.065586,"Moreover, the effect of TPE outperforms HP on the EC injury biomarkers with statistically significant differences ( P   <  .05).","[{'ForeName': 'Junting', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': 'Affiliated Hospital of Putian University, Putian, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Affiliated Hospital of Putian University, Putian, China.'}, {'ForeName': 'Dexiang', 'Initials': 'D', 'LastName': 'Fang', 'Affiliation': 'Affiliated Hospital of Putian University, Putian, China.'}, {'ForeName': 'Danjuan', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Affiliated Hospital of Putian University, Putian, China.'}, {'ForeName': 'Rongjie', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Affiliated Hospital of Putian University, Putian, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Affiliated Hospital of Putian University, Putian, China.'}]",Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis,['10.1177/10760296211053313']
1264,34775781,Efpeglenatide and Clinical Outcomes With and Without Concomitant Sodium-Glucose Cotransporter-2 Inhibition Use in Type 2 Diabetes: Exploratory Analysis of the AMPLITUDE-O Trial.,"BACKGROUND


Both sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists reduce cardiovascular events among patients with type 2 diabetes. However, no cardiovascular outcome trial has evaluated the long-term effects of their combined use. The AMPLITUDE-O trial (Effect of Efpeglenatide on Cardiovascular Outcomes) reported that once-weekly injections of the glucagon-like peptide-1 receptor agonists efpeglenatide (versus placebo) reduced major adverse cardiovascular events (MACEs); MACEs, coronary revascularization, or unstable angina hospitalization (expanded MACEs); a renal composite outcome; and MACEs or death in people with type 2 diabetes and cardiovascular or renal disease. The trial uniquely stratified randomization by baseline or anticipated use of SGLT2 inhibitors and included the highest prevalence at baseline (N=618, 15.2%) of SGLT2 inhibitor use among glucagon-like peptide-1 receptor agonist cardiovascular outcome trials to date. Its results were analyzed to estimate the combined effect of SGLT2 inhibitors and efpeglenatide on clinical outcomes.
METHODS


Cardiovascular and renal outcomes were analyzed with Cox proportional hazards models adjusted for region, SGLT2 inhibitor randomization strata, and the SGLT2 inhibitor-by-treatment interaction. Continuous variables were analyzed with a mixed-effects models for repeated measures that also included an interaction term.
RESULTS


The effect (hazard ratio [95% CI]) of efpeglenatide versus placebo in the absence and presence of baseline SGLT2 inhibitors on MACEs (0.74 [0.58-0.94] and 0.70 [0.37-1.30], respectively), expanded MACEs (0.77 [0.62-0.96] and 0.87 [0.51-1.48]), renal composite (0.70 [0.59-0.83] and 0.52 [0.33-0.83]), and MACEs or death (0.74 [0.59-0.93] and 0.65 [0.36-1.19]) did not differ by baseline SGLT2 inhibitor use ( P  for all interactions >0.2). The reduction of blood pressure, body weight, low-density lipoprotein cholesterol, and urinary albumin-to-creatinine ratio by efpeglenatide also appeared to be independent of concurrent SGLT2 inhibitor use (all interaction  P ≥0.08). Last, adverse events did not differ by baseline SGLT2 inhibitor use.
CONCLUSIONS


The efficacy and safety of efpeglenatide appear to be independent of concurrent SGLT2 inhibitor use. These data support combined SGLT2 inhibitor and glucagon-like peptide-1 receptor agonist therapy in type 2 diabetes. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03496298.",2022,"Efpeglenatide's reduction of blood pressure, body weight, low density lipoprotein cholesterol and urinary albumin:creatinine ratio also appeared to be independent of concurrent SGLT2 inhibitor use (all interaction P ≥0.08).","['Type 2 Diabetes', 'people with type 2 diabetes and CV and/or renal disease', 'patients with type 2 diabetes']","['placebo', 'SGLT2 inhibitor and GLP-1 RA therapy', 'GLP-1 RA efpeglenatide (vs. placebo', 'Concomitant Sodium-Glucose Co-Transporter-2 Inhibition Use', 'Sodium-glucose co-transporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1 RAs']","['Cardiovascular and renal outcomes', 'cardiovascular (CV) events', 'blood pressure, body weight, low density lipoprotein cholesterol and urinary albumin:creatinine ratio', 'adverse events', 'renal composite', 'major adverse cardiovascular events (MACE); MACE, coronary revascularization or unstable angina hospitalization (expanded MACE); a renal composite outcome; and MACE or death', 'MACE or death']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.259955,"Efpeglenatide's reduction of blood pressure, body weight, low density lipoprotein cholesterol and urinary albumin:creatinine ratio also appeared to be independent of concurrent SGLT2 inhibitor use (all interaction P ≥0.08).","[{'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.).'}, {'ForeName': 'Chinthanie', 'Initials': 'C', 'LastName': 'Ramasundarahettige', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, ON, Canada (C.R., H.C.G.).'}, {'ForeName': 'Kelley R H', 'Initials': 'KRH', 'LastName': 'Branch', 'Affiliation': 'Division of Cardiology, University of Washington, Seattle (K.R.H.B.).'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK (N.S.).'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, TX (J.R.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, FL (R.P.).'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Italy (S.D.P.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Sanofi, Frankfurt, Germany (E.N.).'}, {'ForeName': 'Nardev S', 'Initials': 'NS', 'LastName': 'Khurmi', 'Affiliation': 'Sanofi, Bridgewater, NJ (N.S.K.).'}, {'ForeName': 'Seungjae', 'Initials': 'S', 'LastName': 'Baek', 'Affiliation': 'Hanmi Pharmaceutical, Songpa-gu, Seoul, Korea (S.B.).'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, ON, Canada (C.R., H.C.G.).'}]",Circulation,['10.1161/CIRCULATIONAHA.121.057934']
1265,34779905,The effect of intraoral aging of the working stainless steel archwire on the rate of premolar extraction space closure: a randomized clinical trial.,"OBJECTIVES


The aims of this study were to investigate the effect of the working archwire intra-aging on the rate of upper first premolar space closure and to measure frictional resistance during space closure.
METHODS


A total of 28 subjects participated in this study. All patients were treated by upper first premolar extraction. Subjects were subdivided into 2 groups: non-replacement side: consisted of the right or left sides of the upper arch where space closure was done using the same 0.019 × 0.025-inch SS; replacement side: comprised the other side of the subjects where the working archwire was replaced with a new one each visit. The working archwire in the upper arch was split into 2 halves (new archwire on one side and old one on the other side); each one-half was connected to the other in the midline by a joining shim. Elastomeric chain was used to close extraction spaces. The amount of space closure (mm) was recorded each visit for 3 months.
RESULTS


In the non-replacement side, the rate of upper space closure was 0.80 mm/month coronally and 0.75 mm/month gingivally. In the replacement side, it was 0.69 mm/month coronally and 0.67 mm/month gingivally (p > 0.05). Mean frictional force for the non-replacement side was 3.58 ± 1.20 N, and it was 2.43 ± 1.21 N for the replacement side (p < 0.01).
CONCLUSIONS


Intraoral archwire aging has no effect on the rate of upper premolar space closure/month although frictional resistance of the aged archwire was higher than of the new one. Clinical relevance No need to replace 0.019 × 0.025-inch SS every visit during space closure to overcome corrosion and frictional resistance.",2022,"In the non-replacement side, the rate of upper space closure was 0.80 mm/month coronally and 0.75 mm/month gingivally.",['28 subjects participated in this study'],"['working stainless steel archwire', 'non-replacement side: consisted of the right or left sides of the upper arch where space closure was done using the same 0.019\u2009×\u20090.025-inch SS; replacement side']","['rate of premolar extraction space closure', 'rate of upper space closure', 'Mean frictional force']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C4517400', 'cui_str': '0.025'}, {'cui': 'C0439204', 'cui_str': 'in - inch'}]","[{'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",28.0,0.0398164,"In the non-replacement side, the rate of upper space closure was 0.80 mm/month coronally and 0.75 mm/month gingivally.","[{'ForeName': 'Rami A', 'Initials': 'RA', 'LastName': 'Al Shayeb', 'Affiliation': 'Division of Orthodontics, Department of Preventive Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, P.O. Box 3030, Irbid, Jordan.'}, {'ForeName': 'Elham S Abu', 'Initials': 'ESA', 'LastName': 'Alhaija', 'Affiliation': 'College of Dental Medicine, Qatar University, P.O. Box 2713, Doha, Qatar. elhama@qu.edu.qa.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Al-Khateeb', 'Affiliation': 'Division of Orthodontics, Department of Preventive Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, P.O. Box 3030, Irbid, Jordan.'}, {'ForeName': 'Ayat H Bani', 'Initials': 'AHB', 'LastName': 'Rashaid', 'Affiliation': 'Department of Chemistry, Faculty of Science, Jordan University of Science and Technology, P.O. Box 3030, Irbid, Jordan.'}]",Clinical oral investigations,['10.1007/s00784-021-04283-y']
1266,34780705,"Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial.","BACKGROUND


The quadrivalent human papillomavirus (HPV) vaccine was shown to prevent infections and lesions related to HPV6, 11, 16, and 18 in a randomised, placebo-controlled study in men aged 16-26 years. We assessed the incidences of external genital warts related to HPV6 or 11, and external genital lesions and anal dysplasia related to HPV6, 11, 16, or 18, over 10 years of follow-up.
METHODS


The 3-year base study was an international, multicentre, double-blind, randomised, placebo-controlled trial done at 71 sites in 18 countries. Eligible participants were heterosexual men (aged 16-23 years) or men who have sex with men (MSM; aged 16-26 years). Men who had clinically detectable anogenital warts or genital lesions at screening that were suggestive of infection with non-HPV sexually transmitted diseases, or who had a history of such findings, were excluded. Eligible participants were randomly assigned (1:1) to receive three doses of either quadrivalent HPV vaccine or placebo on day 1, month 2, and month 6, administered as a 0·5-mL injection into the deltoid muscle. The 7-year, open-label, long-term follow-up extension study was done at 46 centres in 16 countries. Participants who received one or more doses of the quadrivalent HPV vaccine in the base study were eligible for enrolment into the long-term follow-up study (early vaccination group). Placebo recipients were offered the three-dose quadrivalent HPV vaccine at the end of the base study; those who received one or more quadrivalent HPV vaccine doses were eligible for enrolment into the long-term follow-up study (catch-up vaccination group). The primary efficacy endpoints were the incidence of external genital warts related to HPV6 or 11 and the incidence of external genital lesions related to HPV6, 11, 16, or 18 in all participants and the incidence of anal intraepithelial neoplasia (including anal warts and flat lesions) or anal cancer related to HPV6, 11, 16, or 18 in MSM only. The primary efficacy analysis was done in the per-protocol population for the early vaccination group, which included participants who received all three vaccine doses, were seronegative at day 1 and PCR-negative from day 1 through month 7 of the base study for the HPV type being analysed, had no protocol violations that could affect evaluation of vaccine efficacy, and had attended at least one visit during the long-term follow-up study. For the catch-up vaccination group, efficacy was assessed in the modified intention-to-treat population, which included participants who had received at least one vaccine dose, were seronegative and PCR-negative for HPV types analysed from day 1 of the base study to the final follow-up visit before receiving the quadrivalent HPV vaccine, and had at least one long-term follow-up visit. Safety was assessed in all randomised participants who received at least one vaccine dose. This study is registered with ClinicalTrials.gov, NCT00090285.
FINDINGS


Between Aug 10, 2010, and April 3, 2017, 1803 participants were enrolled in the long-term follow-up study, of whom 936 (827 heterosexual men and 109 MSM) were included in the early vaccination group and 867 (739 heterosexual men and 128 MSM) were included in the catch-up vaccination group. Participants in the early vaccination group were followed up for a median of 9·5 years (range 0·1-11·5) after receiving the third dose of the quadrivalent HPV vaccine, and participants in the catch-up vaccination group were followed up for a median of 4·7 years (0·0-6·6) after receiving the third dose. In early vaccine group participants during long-term follow-up compared with the placebo group in the base study, the incidence per 10 000 person-years of external genital warts related to HPV6 or 11 was 0·0 (95% CI 0·0-8·7) versus 137·3 (83·9-212·1), of external genital lesions related to HPV6, 11, 16, or 18 was 0·0 (0·0-7·7) versus 140·4 (89·0-210·7), and of anal intraepithelial neoplasia or anal cancer related to HPV6, 11, 16, or 18 in MSM only was 20·5 (0·5-114·4) versus 906·2 (553·5-1399·5). Compared with during the base study (ie, before quadrivalent HPV vaccine administration), during the long-term follow-up period, participants in the catch-up vaccination group had no new reported cases of external genital warts related to HPV6 or 11 (149·6 cases per 10 000 person-years [95% CI 101·6-212·3] vs 0 cases per 10 000 person-years [0·0-13·5]) or external genital lesions related to HPV6, 11, 16, or 18 (155·1 cases per 10 000 person-years [108·0-215·7] vs 0 cases per 10 000 person-years [0·0-10·2]), and a lower incidence of anal intraepithelial neoplasia or anal cancer related to HPV6, 11, 16, or 18 (886·0 cases per 10 000 person-years [583·9-1289·1] vs 101·3 cases per 10 000 person-years [32·9-236·3]). No vaccine-related serious adverse events were reported.
INTERPRETATION


The quadrivalent HPV vaccine provides durable protection against anogenital disease related to HPV6, 11, 16, and 18. The results support quadrivalent HPV vaccination in men, including catch-up vaccination.
FUNDING


Merck Sharp & Dohme.",2022,"The quadrivalent HPV vaccine provides durable protection against anogenital disease related to HPV6, 11, 16, and 18.","['Men who had clinically detectable anogenital warts or genital lesions at screening that were suggestive of infection with non-HPV sexually transmitted diseases, or who had a history of such findings, were excluded', 'men aged 16-26 years', 'Between Aug 10, 2010, and April 3, 2017, 1803 participants were enrolled in the long-term follow-up study, of whom 936 (827 heterosexual men and 109 MSM) were included in the early vaccination group and 867 (739 heterosexual men and 128 MSM) were included in the catch-up vaccination group', 'Eligible participants were heterosexual men (aged 16-23 years) or men who have sex with men (MSM; aged 16-26 years', 'men', 'group in the base study, the incidence per 10\u2008000 person-years of external genital warts related to HPV6 or 11 was 0·0', 'Eligible participants', '71 sites in 18 countries', 'Participants who received one or more doses of the quadrivalent HPV vaccine in the base study were eligible for enrolment into the long-term follow-up study (early vaccination group']","['quadrivalent HPV vaccine or placebo', 'quadrivalent HPV vaccine', 'placebo', 'Placebo']","['incidence of external genital warts related to HPV6 or 11 and the incidence of external genital lesions', 'incidences of external genital warts related to HPV6 or 11, and external genital lesions and anal dysplasia', 'incidence of anal intraepithelial neoplasia (including anal warts and flat lesions) or anal cancer related to HPV6', 'anal intraepithelial neoplasia or anal cancer', 'Safety', 'Efficacy, immunogenicity, and safety']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0009663', 'cui_str': 'Genital warts'}, {'cui': 'C0744369', 'cui_str': 'Lesion of genitalia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1815829', 'cui_str': 'Human papillomavirus type 6, 11, 16, and 18 vaccine'}]","[{'cui': 'C1815829', 'cui_str': 'Human papillomavirus type 6, 11, 16, and 18 vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0009663', 'cui_str': 'Genital warts'}, {'cui': 'C0744369', 'cui_str': 'Lesion of genitalia'}, {'cui': 'C0347129', 'cui_str': 'Dysplasia of anus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0343729', 'cui_str': 'Anal warts'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0153446', 'cui_str': 'Malignant tumor of anus'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1803.0,0.285317,"The quadrivalent HPV vaccine provides durable protection against anogenital disease related to HPV6, 11, 16, and 18.","[{'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Goldstone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: goldstone.stephen@gmail.com.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Giuliano', 'Affiliation': 'Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Palefsky', 'Affiliation': 'Department of Medicine, University of California at San Francisco, CA, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Lazcano-Ponce', 'Affiliation': 'Instituto Nacional de Salud Pública, Santa María Ahuacatitlán, Cuernavaca, México.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Penny', 'Affiliation': 'Instituto de Investigación Nutricional, Lima, Peru.'}, {'ForeName': 'Robinson E', 'Initials': 'RE', 'LastName': 'Cabello', 'Affiliation': 'Asociación Via Libre, Lima, Peru.'}, {'ForeName': 'Edson D', 'Initials': 'ED', 'LastName': 'Moreira', 'Affiliation': 'Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Bahia, Brazil.'}, {'ForeName': 'Ezio', 'Initials': 'E', 'LastName': 'Baraldi', 'Affiliation': 'Trialtech Research Institute, Pretoria, South Africa.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Jessen', 'Affiliation': 'Praxis Jessen(2)\u2008+\u2008Kollegen, Berlin, Germany.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ferenczy', 'Affiliation': 'McGill University Health Center, Montreal, QC, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kurman', 'Affiliation': 'Department of Gynecology and Obstetrics and Department of Pathology Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Brigitte M', 'Initials': 'BM', 'LastName': 'Ronnett', 'Affiliation': 'Department of Gynecology and Obstetrics and Department of Pathology Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Stoler', 'Affiliation': 'Department of Pathology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bautista', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Rituparna', 'Initials': 'R', 'LastName': 'Das', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Group', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Luxembourg', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Hao Jin', 'Initials': 'HJ', 'LastName': 'Zhou', 'Affiliation': 'MSD China, Beijing, China; Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Saah', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(21)00327-3']
1267,34783404,Evaluation of composite restorations in primary molars subjected to selective caries removal associated with antimicrobial photodynamic therapy: A randomized controlled trial.,"BACKGROUND


Antimicrobial photodynamic therapy (aPDT) has been used as an adjunct treatment of deep caries lesions; however, studies on the effects of aPDT on the longevity of restorations are still limited.
AIM


To evaluate the clinical performance of composite restorations in primary molars subjected to selective caries removal (SCR) associated with aPDT.
DESIGN


A randomized clinical trial was designed. Primary molars of patients (mean age 6.15 years) with deep caries lesions without signs and symptoms of pulpal involvement were selected. A total of 64 teeth were randomly divided into groups G1 (SCR, 32 teeth) and G2 (SCR + aPDT, 32 teeth) for treatment, restored with composite, and evaluated after a week (T 0  ), 6 months (T 1  ), and 12 months (T 2  ) according to the criteria of FDI. Groups were compared using the Rao-Scott chi-squared test and the logistic regression analysis for complex designs to account for multiple observations per subject (alpha = 0.05).
RESULTS


From all FDI criteria evaluated, the marginal adaptation for the SCR + aPDT group was significantly better in comparison with the SCR group at T0 and T2 in the logistic regression analysis (T0: OR = 0.151; 95% CI = 0.03-0.068, P = .015; and T2: OR = 0.201; 95% CI = 0.05-0.79, P = .022).
CONCLUSION


The marginal adaptation of primary molar resin restorations was positively affected by aPDT after 12 months of follow-up.",2021,Marginal adaptation for the SCR + aPDT group was significantly better in comparison to SCR group at T0 and T2 in Logistic Regression (T0: OR= 0.151; 95% CI = 0.03 - 0.068; p = 0.015.,"['Primary molars of patients (mean age 6.15 years) with deep carious lesions without signs and symptoms of pulp involvement were selected', 'A total of 64 teeth', 'primary molars subjected to selective caries removal (SCR) associated with aPDT']","['SCR + aPDT', 'antimicrobial photodynamic therapy', 'Antimicrobial photodynamic therapy (aPDT']","['marginal adaptation of primary molar resin restorations', 'Marginal adaptation']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0204229', 'cui_str': 'Restoration, resin'}]",64.0,0.0748812,Marginal adaptation for the SCR + aPDT group was significantly better in comparison to SCR group at T0 and T2 in Logistic Regression (T0: OR= 0.151; 95% CI = 0.03 - 0.068; p = 0.015.,"[{'ForeName': 'Laís Veiga', 'Initials': 'LV', 'LastName': 'Faria', 'Affiliation': 'Postgraduate Program in Dentistry of Niterói, Faculty of Dentistry, Federal Fluminense University, Niterói, Brazil.'}, {'ForeName': 'Leonardo Santos', 'Initials': 'LS', 'LastName': 'Antunes', 'Affiliation': 'Postgraduate Program in Dentistry of Niterói, Faculty of Dentistry, Federal Fluminense University, Niterói, Brazil.'}, {'ForeName': 'Luciana Ribeiro Reis', 'Initials': 'LRR', 'LastName': 'Pio', 'Affiliation': 'Department of Specific Formation, Health Institute of Nova Friburgo, School of Dentistry, Fluminense Federal University, Nova Friburgo, Brazil.'}, {'ForeName': 'Jessica Coelho', 'Initials': 'JC', 'LastName': 'Dias', 'Affiliation': 'Department of Specific Formation, Health Institute of Nova Friburgo, School of Dentistry, Fluminense Federal University, Nova Friburgo, Brazil.'}, {'ForeName': 'Liz Helena Moraes', 'Initials': 'LHM', 'LastName': 'Pinheiro', 'Affiliation': 'Postgraduate Program in Dentistry, Health Institute of Nova Friburgo, Fluminense Federal University, Nova Friburgo, Brazil.'}, {'ForeName': 'Caio Luiz Bitencourt', 'Initials': 'CLB', 'LastName': 'Reis', 'Affiliation': 'Postgraduate Program in Pediatric Dentistry, São Paulo University, Ribeirão Preto, Brazil.'}, {'ForeName': 'Karla Bianca Fernandes Costa', 'Initials': 'KBFC', 'LastName': 'Fontes', 'Affiliation': 'Department of Specific Formation, Health Institute of Nova Friburgo, School of Dentistry, Fluminense Federal University, Nova Friburgo, Brazil.'}, {'ForeName': 'Marlus Roberto Rodrigues', 'Initials': 'MRR', 'LastName': 'Cajazeira', 'Affiliation': 'Department of Specific Formation, Health Institute of Nova Friburgo, School of Dentistry, Fluminense Federal University, Nova Friburgo, Brazil.'}, {'ForeName': 'Lívia Azeredo Alves', 'Initials': 'LAA', 'LastName': 'Antunes', 'Affiliation': 'Postgraduate Program in Dentistry of Niterói, Faculty of Dentistry, Federal Fluminense University, Niterói, Brazil.'}]",International journal of paediatric dentistry,['10.1111/ipd.12937']
1268,34783270,Breathing exercises versus strength exercises through telerehabilitation in coronavirus disease 2019 patients in the acute phase: A randomized controlled trial.,"OBJECTIVE


To compare the effectiveness of two different exercise-based programs through telerehabilitation in patients with coronavirus disease 2019.
DESIGN


Randomized, controlled, parallel, double-blinded, three-arm clinical trial.
SETTING


Patients' homes through telerehabilitation devices.
SUBJECTS


Subjects with coronavirus disease 2019 in the acute phase.
INTERVENTIONS


Subjects were divided into three groups: breathing exercises group, strength exercises group or no treatment/control group.
MAIN MEASURES


We analysed visual analogue scale for fatigue, 6-minute walking test, 30-seconds sit-to-stand test, multidimensional dyspnoea-12 questionnaire and Borg scale at baseline and 14 days later.
RESULTS


From 93 subjects recruited, 88 were enrolled, and 77 patients (mean [SD] age 39.40 [11.71]) completed the 14-days intervention and were included in the analysis: 26 in strength exercises group, 29 in breathing exercises group and 22 in control group. The intergroup analysis shows significant differences between the study groups and control group in all variables ( p  < 0.05); Borg scale, multidimensional dyspnoea-12 questionnaire (pre-post intervention score: strength exercises group: 7.85 [6.82] - 4.54[4.82], breathing exercises group: 11.04 [6.49] - 5.32 [3.63], control group: 10.27 [6.49] - 10.59[6.58]), visual analogue scale for fatigue, 6-minute walking test and 30-seconds sit-to-stand test (pre-post intervention score: strength exercises group: 12.19 [4.42] - 13.58 [5.37], breathing exercises group: 11.18 [3.42] - 12.79 [4.00], control group: 10.45 [2.15] - 9.86[1.88]). The greatest effect sizes were found in the variables Borg Scale ( R 2  = 0.548) and multidimensional dyspnoea-12 questionnaire ( R 2  = 0.475).
CONCLUSIONS


Strength exercises group and breathing exercises group obtained significant improvements in fatigue, dyspnoea, perceived effort, and physical state, compared to control group, although the greatest benefits were found for dyspnoea and aerobic capacity in breathing exercises group.",2022,"The intergroup analysis shows significant differences between the study groups and control group in all variables ( p  < 0.05); Borg scale, multidimensional dyspnoea-12 questionnaire (pre-post intervention score: strength exercises group: 7.85 [6.82] - 4.54[4.82], breathing exercises group: 11.04 [6.49] - 5.32 [3.63], control group: 10.27 [6.49] - 10.59[6.58]), visual analogue scale for fatigue, 6-minute walking test and 30-seconds sit-to-stand test (pre-post intervention score: strength exercises group: 12.19 [4.42] - 13.58 [5.37], breathing exercises group: 11.18 [3.42] - 12.79 [4.00], control group: 10.45 [2.15] - 9.86[1.88]).","['From 93 subjects recruited, 88 were enrolled, and 77 patients (mean [SD] age 39.40 [11.71]) completed the 14-days intervention and were included in the analysis: 26 in', 'Subjects with coronavirus disease 2019 in the acute phase', 'coronavirus disease 2019 patients in the acute phase', 'patients with coronavirus disease 2019', ""Patients' homes through telerehabilitation devices""]","['breathing exercises group, strength exercises group or no treatment/control group', 'exercise-based programs through telerehabilitation', 'Breathing exercises versus strength exercises through telerehabilitation', 'Strength exercises group and breathing exercises', 'strength exercises group, 29 in breathing exercises group and 22 in control group']","['visual analogue scale for fatigue, 6-minute walking test, 30-seconds sit-to-stand test, multidimensional dyspnoea-12 questionnaire and Borg scale', 'dyspnoea and aerobic capacity', 'visual analogue scale for fatigue, 6-minute walking test and 30-seconds sit-to-stand test', 'multidimensional dyspnoea-12 questionnaire', 'fatigue, dyspnoea, perceived effort, and physical state']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449399', 'cui_str': 'Borg scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0597240', 'cui_str': 'State of matter'}]",93.0,0.0537656,"The intergroup analysis shows significant differences between the study groups and control group in all variables ( p  < 0.05); Borg scale, multidimensional dyspnoea-12 questionnaire (pre-post intervention score: strength exercises group: 7.85 [6.82] - 4.54[4.82], breathing exercises group: 11.04 [6.49] - 5.32 [3.63], control group: 10.27 [6.49] - 10.59[6.58]), visual analogue scale for fatigue, 6-minute walking test and 30-seconds sit-to-stand test (pre-post intervention score: strength exercises group: 12.19 [4.42] - 13.58 [5.37], breathing exercises group: 11.18 [3.42] - 12.79 [4.00], control group: 10.45 [2.15] - 9.86[1.88]).","[{'ForeName': 'Cleofas', 'Initials': 'C', 'LastName': 'Rodríguez-Blanco', 'Affiliation': 'Fisiosur I + D Research Institute, Garrucha, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bernal-Utrera', 'Affiliation': 'Fisiosur I + D Research Institute, Garrucha, Spain.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Anarte-Lazo', 'Affiliation': 'Doctoral Program in Health Sciences, 16778University of Seville, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Saavedra-Hernandez', 'Affiliation': 'Fisiosur I + D Research Institute, Garrucha, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'De-La-Barrera-Aranda', 'Affiliation': 'Department of Morphological and Socio-Health Sciences, 16735University of Cordoba, Spain.'}, {'ForeName': 'Maria Angeles', 'Initials': 'MA', 'LastName': 'Serrera-Figallo', 'Affiliation': 'Stomatology Department, Faculty of Dentistry, 16778University of Seville, Spain.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Gonzalez-Martin', 'Affiliation': 'Stomatology Department, Faculty of Dentistry, 16778University of Seville, Spain.'}, {'ForeName': 'Juan Jose', 'Initials': 'JJ', 'LastName': 'Gonzalez-Gerez', 'Affiliation': 'Fisiosur I + D Research Institute, Garrucha, Spain.'}]",Clinical rehabilitation,['10.1177/02692155211061221']
1269,34792290,"A psychological intervention for caries active young adults, a randomized controlled trial.","OBJECTIVE


The aim of the present study was to evaluate the effect of a brief version of the behavioral intervention Acceptance and Commitment Therapy (ACT) on reducing gingivitis and plaque levels after 18 weeks.
MATERIALS AND METHODS


One hundred thirty-five caries-active young adults (18-25 years of age), recruited from two public dental clinics, participated in this parallel group randomized control trial (RCT). Participants in the intervention (n = 67) received two ACT sessions in combination with standard information on oral health, and participants allocated to the control group (n = 68) received standard information only. Gingivitis and plaque levels were recorded at baseline and at the 9- and 18-week follow-ups. The effect of the intervention versus standard information alone was analyzed by intention-to-treat and per protocol, applying the General Linear Model (GLM). Exploratory analyses for the intervention and control groups were conducted to evaluate the effect of gender and smoking habits on the gingivitis and plaque outcome. The CONSORT guidelines for RCT were followed.
RESULTS


A significant decrease in gingivitis and plaque levels was observed over time, irrespective of treatment allocation. However, the ACT intervention was not significantly more effective at reducing gingivitis and plaque scores than standard information alone, even though the intervention participants had maintained their improvement to a greater extent. The exploratory analysis revealed that females improved their gingivitis and plaque levels significantly more than the males in the intervention group (p = 0.025 for gingivitis and p = 0.013 for plaque).
CONCLUSION


A brief ACT intervention was not proven to be more effective than standard information alone at improving oral health in a sample of young adults with poor oral health. However, ACT seems to have a positive effect on oral health among females. (TRN ISRCTN15009620).",2022,"The exploratory analysis revealed that females improved their gingivitis and plaque levels significantly more than the males in the intervention group (p = 0.025 for gingivitis and p = 0.013 for plaque).
","['One hundred thirty-five caries-active young adults (18-25\u2009years of age), recruited from two public dental clinics', 'caries active young adults', 'young adults with poor oral health']","['ACT intervention', 'behavioral intervention Acceptance and Commitment Therapy (ACT', 'ACT sessions in combination with standard information on oral health, and participants allocated to the control group (n\xa0=\xa068) received standard information only', 'psychological intervention']","['gingivitis and plaque levels', 'Gingivitis and plaque levels', 'gingivitis and plaque scores']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0429170', 'cui_str': 'Caries active'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011344', 'cui_str': 'Dental clinic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",135.0,0.0341389,"The exploratory analysis revealed that females improved their gingivitis and plaque levels significantly more than the males in the intervention group (p = 0.025 for gingivitis and p = 0.013 for plaque).
","[{'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Hagman', 'Affiliation': 'Department of Behavioral and Community Dentistry, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Wide', 'Affiliation': 'Department of Behavioral and Community Dentistry, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Werner', 'Affiliation': 'Department of Behavioral and Community Dentistry, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Hakeberg', 'Affiliation': 'Department of Behavioral and Community Dentistry, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Clinical and experimental dental research,['10.1002/cre2.513']
1270,34766790,"Autonomic reactivity to social rejection, peer difficulties, and the buffering effects of adolescent friendships following early psychosocial deprivation.","Autonomic nervous system reactivity has been posited to be a mechanism contributing to social and emotional problems among children exposed to early adversity. Leveraging data from the Bucharest Early Intervention Project, a longitudinal randomized controlled trial of foster care versus institutional care of abandoned children in Romania, we assessed whether altered sympathetic reactivity to peer rejection feedback in early adolescence mediated the relation between early institutional rearing and peer problems in later adolescence. We also assessed whether adolescent friendship quality or randomized placement in foster care early in life moderated these associations. Participants include 68 institutionalized children randomized to care as usual, 68 institutionalized children randomized to foster care, and 135 never-institutionalized children. At age 12, participants reported friendship quality with respect to a best friend and completed a social rejection task while electrocardiogram and impedance cardiography were recorded. Sympathetic nervous system reactivity to rejection feedback was assessed using preejection period (PEP). At ages 12 and 16, peer problems were reported by parents. Mediation analysis revealed that less PEP reactivity to social rejection at age 12 partially mediated the association between early institutionalization and greater peer problems at age 16. Further moderated mediation analysis revealed that this indirect effect was evidenced among previously institutionalized youths with low, but not high, quality friendships. We did not observe foster care intervention effects. These findings suggest that altered sympathetic reactivity to social rejection might be a mechanism linking early institutionalization to social difficulties into adolescence, however, positive adolescent friendships may buffer these effects. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,We did not observe foster care intervention effects.,"['Participants include 68 institutionalized children randomized to care as usual, 68 institutionalized children randomized to foster care, and 135 never-institutionalized children']",[],"['PEP reactivity to social rejection', 'social rejection task while electrocardiogram and impedance cardiography', 'adolescent friendship quality', 'friendship quality']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008099', 'cui_str': 'Institutionalized Child'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],"[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0237827', 'cui_str': 'Social exclusion'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0007185', 'cui_str': 'Impedance Cardiography'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",68.0,0.0223038,We did not observe foster care intervention effects.,"[{'ForeName': 'Alva', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Department of Human Development and Quantitative Methodology.'}, {'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'McLaughlin', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Sheridan', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Boston Children's Hospital.""}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology.'}]","Emotion (Washington, D.C.)",['10.1037/emo0001016']
1271,34766787,Cross-cultural comparisons of the effect of a schizophrenia label on stigmatizing family attitudes: A case vignette study.,"It has been proposed that stigmatizing attitudes toward a family member with schizophrenia are less prevalent in low- and middle-income countries (LAMIC) than in high-income countries (HIC). Furthermore, studies from HIC have shown that labeling increases certain aspects of stigma. This raises concerns about an export of this Western psychiatric labeling practice to LAMIC. The aim of the present research was to determine (a) whether stigmatizing family attitudes are less prevalent in LAMIC than in HIC and (b) whether stigmatizing family attitudes are intensified in both country types by introducing a schizophrenia label. Adults from two HIC ( n  = 718) and four LAMIC ( n  = 763) participated in the online study by reading a vignette, which depicted a family member presenting schizophrenia symptoms. Participants were randomly allocated to receive either the label (mental illness called schizophrenia) or the no label condition. Stigma-related stereotypes, emotions, and negative family affect were measured. A two-way multivariate analysis of covariance was conducted. This analysis revealed that participants from LAMIC showed significantly less stigmatizing attitudes toward their family members compared to those from HIC. Introducing a schizophrenia label significantly increased stigmatizing family attitudes in both country types, but the association between labeling and family attitudes was stronger in HIC than in LAMIC. Our results indicate that family attitudes toward schizophrenia and associated labeling effects differ between countries with varying economic strata and cultural values. This needs to be considered in stigma research and in the tailoring of antistigma interventions. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,"Introducing a schizophrenia label significantly increased stigmatizing family attitudes in both country types, but the association between labeling and family attitudes was stronger in HIC than in LAMIC.","['stigmatizing family attitudes', 'Adults from two HIC ( n  = 718) and four LAMIC ( n  = 763) participated in the online study by reading a vignette, which depicted a family member presenting schizophrenia symptoms']","['schizophrenia label', 'label (mental illness called schizophrenia) or the no label condition']","['stigmatizing attitudes', 'stigmatizing family attitudes', 'Stigma-related stereotypes, emotions, and negative family affect']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",,0.0447238,"Introducing a schizophrenia label significantly increased stigmatizing family attitudes in both country types, but the association between labeling and family attitudes was stronger in HIC than in LAMIC.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wüsten', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}, {'ForeName': 'Tania M', 'Initials': 'TM', 'LastName': 'Lincoln', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}]",Journal of psychopathology and clinical science,['10.1037/abn0000708']
1272,34773608,Comparison of Pharmacokinetics and Pharmacodynamics of Inhaled Technosphere Insulin and Subcutaneous Insulin Lispro in the Treatment of Type 1 Diabetes Mellitus.,"BACKGROUND


This study was performed to satisfy a US Food and Drug Administration post-marketing requirement to compare the dose responses for Technosphere ®  Insulin (TI; MannKind Corporation, Westlake Village, CA, USA) and subcutaneous insulin lispro (LIS) across a wide range of doses.
OBJECTIVES


This single-center, open-label, randomized, cross-over study defined the pharmacokinetic/pharmacodynamic curves for inhaled TI vs subcutaneous LIS in persons with type 1 diabetes mellitus.
METHODS


Each volunteer received six treatments while undergoing euglycemic clamps: three doses of TI (10, 30 and 120 U) and LIS (8, 30, and 90 U). Primary endpoint was area under the glucose infusion rate vs time curve from start of treatment administration to end of clamp. Key secondary endpoints included readouts of insulin exposure and timing of pharmacokinetic/pharmacodynamic profiles.
RESULTS


Insulin exposure was more than dose proportional, increasing with dose 1.08  for LIS and dose 1.35  for TI. Time to reach 10% of the maximum glucose infusion rate was 7 to 15 min for TI vs 21 to 38 min for LIS. End of effect was dose dependent for both treatments, ranging from 2 to 6 h (TI) and 5 to 10 h (LIS). Glucose infusion rate exhibited saturation for both treatments. Technosphere Insulin produced a lesser total effect per unit insulin than LIS due to its faster absorption and correspondingly shorter duration of exposure. The difference was large enough to require significantly different doses to achieve the same total effect.
CONCLUSIONS


Technosphere Insulin has a considerably faster onset and shorter duration of action than LIS. Consequently, the overall effect of TI is smaller than that of LIS and unit-for-unit dose conversion is not appropriate.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02470637; 12 June, 2015.",2022,"RESULTS


Insulin exposure was more than dose proportional, increasing with dose 1.08  for LIS and dose 1.35  for TI.","['Type 1 Diabetes Mellitus', 'persons with type 1 diabetes mellitus']","['inhaled TI vs subcutaneous LIS', 'six treatments while undergoing euglycemic clamps: three doses of TI', 'Technosphere Insulin', 'Inhaled Technosphere Insulin and Subcutaneous Insulin Lispro']","['readouts of insulin exposure and timing of pharmacokinetic/pharmacodynamic profiles', 'maximum glucose infusion rate', 'area under the glucose infusion rate vs time curve']","[{'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.116308,"RESULTS


Insulin exposure was more than dose proportional, increasing with dose 1.08  for LIS and dose 1.35  for TI.","[{'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Grant', 'Affiliation': 'MannKind Corporation, 30930 Russell Ranch Rd, Suite 300, Westlake Village, CA, 91362, USA. mgrant@mannkindcorp.com.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Baughman', 'Affiliation': 'Takeda Pharmaceutical Company Ltd, Lexington, MA, USA.'}]",Clinical pharmacokinetics,['10.1007/s40262-021-01084-0']
1273,34773606,Finerenone Dose-Exposure-Response for the Primary Kidney Outcome in FIDELIO-DKD Phase III: Population Pharmacokinetic and Time-to-Event Analysis.,"BACKGROUND


Finerenone is a nonsteroidal selective mineralocorticoid receptor antagonist that recently demonstrated efficacy in delaying chronic kidney disease progression and reducing cardiovascular events in patients with chronic kidney disease and type 2 diabetes in FIDELIO-DKD, where 5734 patients were randomized 1:1 to receive either titrated finerenone doses of 10 or 20 mg once daily or placebo, with a median follow-up of 2.6 years.
METHODS


Nonlinear mixed-effects population pharmacokinetic models were used to analyze the pharmacokinetics in FIDELIO-DKD, sparsely sampled in all subjects receiving finerenone. Post-hoc model parameter estimates together with dosing histories allowed the computation of individual exposures used in subsequent parametric time-to-event analyses of the primary kidney outcome.
RESULTS


The population pharmacokinetic model adequately captured the typical pharmacokinetics of finerenone and its variability. Either covariate effects or multivariate forward-simulations in subgroups of interest were contained within the equivalence range of 80-125% around typical exposure. The exposure-response relationship was characterized by a maximum effect model estimating a low half-maximal effect concentration at 0.166 µg/L and a maximal hazard decrease at 36.1%. Prognostic factors for the treatment-independent chronic kidney disease progression risk included a low estimated glomerular filtration rate and a high urine-to-creatinine ratio increasing the risk, while concomitant sodium-glucose transport protein 2 inhibitor use decreased the risk. Importantly, no sodium-glucose transport protein 2 inhibitor co-medication-related modification of the finerenone treatment effect per se could be identified.
CONCLUSIONS


None of the tested pharmacokinetic covariates had clinical relevance in FIDELIO-DKD. Finerenone effects on kidney outcomes approached saturation towards 20 mg once daily and sodium-glucose transport protein 2 inhibitor use provided additive benefits.",2022,"Prognostic factors for the treatment-independent chronic kidney disease progression risk included a low estimated glomerular filtration rate and a high urine-to-creatinine ratio increasing the risk, while concomitant sodium-glucose transport protein 2 inhibitor use decreased the risk.","['patients with chronic kidney disease and type 2 diabetes in FIDELIO-DKD, where 5734 patients']","['titrated finerenone doses of 10 or 20\xa0mg once daily or placebo', 'finerenone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C4045511', 'cui_str': 'finerenone'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],5734.0,0.0195742,"Prognostic factors for the treatment-independent chronic kidney disease progression risk included a low estimated glomerular filtration rate and a high urine-to-creatinine ratio increasing the risk, while concomitant sodium-glucose transport protein 2 inhibitor use decreased the risk.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'van den Berg', 'Affiliation': 'Leiden Experts on Advanced Pharmacokinetics and Pharmacodynamics (LAP&P), Leiden, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Ruppert', 'Affiliation': 'Leiden Experts on Advanced Pharmacokinetics and Pharmacodynamics (LAP&P), Leiden, The Netherlands.'}, {'ForeName': 'Emir', 'Initials': 'E', 'LastName': 'Mesic', 'Affiliation': 'Leiden Experts on Advanced Pharmacokinetics and Pharmacodynamics (LAP&P), Leiden, The Netherlands.'}, {'ForeName': 'Nelleke', 'Initials': 'N', 'LastName': 'Snelder', 'Affiliation': 'Leiden Experts on Advanced Pharmacokinetics and Pharmacodynamics (LAP&P), Leiden, The Netherlands.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Seelmann', 'Affiliation': 'Pharmacometrics, Pharmaceuticals R&D, Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Heinig', 'Affiliation': 'Clinical Pharmacology, Pharmaceuticals R&D, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Joseph', 'Affiliation': 'Clinical Development, Pharmaceuticals R&D, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Garmann', 'Affiliation': 'Pharmacometrics, Pharmaceuticals R&D, Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Lippert', 'Affiliation': 'Pharmacometrics, Pharmaceuticals R&D, Bayer AG, Leverkusen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissing', 'Affiliation': 'Pharmacometrics, Pharmaceuticals R&D, Bayer AG, Leverkusen, Germany. thomas.eissing@bayer.com.'}]",Clinical pharmacokinetics,['10.1007/s40262-021-01082-2']
1274,34779234,"Assessment of Impact of Patient Recruitment Volume on Risk Profile, Outcomes, and Treatment Effect in a Randomized Trial of Ticagrelor Versus Prasugrel in Acute Coronary Syndromes.","BACKGROUND Whether there are differences in the risk profile and treatment effect in patients recruited in a low recruitment center (LRC) versus patients recruited in a high recruitment center (HRC) in a randomized multicenter trial remains unknown. METHODS AND RESULTS This study included 4018 patients with acute coronary syndrome recruited in the ISAR-REACT 5 (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5) trial. The primary end point was a composite of all-cause death, myocardial infarction, or stroke. Overall, 3011 patients (75%) were recruited in the HRCs (7 centers recruiting 258 to 628 patients; median, 413 patients) and 1007 patients (25%) were recruited in the LRCs (16 centers recruiting 5 to 201 patients; median, 52 patients). Patients recruited in the LRCs had more favorable cardiovascular risk profiles than patients recruited in the HRCs. The primary end point occurred in 72 patients in the LRCs and 249 patients in the HRCs (cumulative incidence, 7.3% and 8.4%;  P =0.267). All-cause mortality was lower among patients recruited in the LRCs (n=29) than among patients recruited in the HRCs (n=134; cumulative incidence 2.9% versus 4.5%;  P =0.031). There was no significant interaction between the treatment effect of ticagrelor versus prasugrel and patient recruitment category (LRC versus HRC) regarding the primary efficacy end point (LRC: hazard ratio [HR], 1.42 [95% CI, 0.89-2.28]; HRC: HR, 1.33 [95% CI, 1.04-1.72];  P  for interaction=0.800). CONCLUSIONS Patients with acute coronary syndrome recruited in a LRC appear to have more favorable cardiovascular risk profiles and lower 1-year mortality rates compared with patients recruited in a HRC. The recruitment volume did not interact with the treatment effect of ticagrelor versus prasugrel. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT01944800.",2021,All-cause mortality was lower among patients recruited in the LRCs (n=29) than among patients recruited in the HRCs (n=134; cumulative incidence 2.9% versus 4.5%;  P =0.031).,"['Patients with acute coronary syndrome', 'patients recruited in a low recruitment center (LRC) versus patients recruited in a high recruitment center (HRC', '4018 patients with acute coronary syndrome recruited in the ISAR-REACT 5 (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5) trial', '3011 patients (75%) were recruited in the HRCs (7 centers recruiting 258 to 628 patients; median, 413 patients) and 1007 patients (25%) were recruited in the LRCs (16 centers recruiting 5 to 201 patients; median, 52 patients', 'Acute Coronary Syndromes']","['Ticagrelor Versus Prasugrel', 'ticagrelor', 'ticagrelor versus prasugrel']","['composite of all-cause death, myocardial infarction, or stroke', 'favorable cardiovascular risk profiles', 'All-cause mortality', '1-year mortality rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439234', 'cui_str': 'year'}]",4018.0,0.179637,All-cause mortality was lower among patients recruited in the LRCs (n=29) than among patients recruited in the HRCs (n=134; cumulative incidence 2.9% versus 4.5%;  P =0.031).,"[{'ForeName': 'Gjin', 'Initials': 'G', 'LastName': 'Ndrepepa', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München Munich Germany.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Department of Cardiology and Angiology II University Heart Center Freiburg Bad Krozingen Bad Krozingen Germany.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Menichelli', 'Affiliation': 'Department of Cardiology Ospedale Fabrizio Spaziani Frosinone Italy.'}, {'ForeName': 'Isabell', 'Initials': 'I', 'LastName': 'Bernlochner', 'Affiliation': 'Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar Munich Germany.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'Heart Center Bad Segeberg Bad Segeberg Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wöhrle', 'Affiliation': 'Department of Cardiology Medical Campus Lake Constance Friedrichshafen Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Witzenbichler', 'Affiliation': 'Department of Cardiology and Pneumology Helios Amper-Klinikum Dachau Dachau Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München Munich Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cassese', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München Munich Germany.'}, {'ForeName': 'Senta', 'Initials': 'S', 'LastName': 'Gewalt', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München Munich Germany.'}, {'ForeName': 'Erion', 'Initials': 'E', 'LastName': 'Xhepa', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München Munich Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kufner', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München Munich Germany.'}, {'ForeName': 'Hendrik B', 'Initials': 'HB', 'LastName': 'Sager', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München Munich Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joner', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München Munich Germany.'}, {'ForeName': 'Tareq', 'Initials': 'T', 'LastName': 'Ibrahim', 'Affiliation': 'Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar Munich Germany.'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': 'Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar Munich Germany.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München Munich Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schüpke', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München Munich Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology and Technische Universität München Munich Germany.'}]",Journal of the American Heart Association,['10.1161/JAHA.121.021418']
1275,34779226,Study Criteria Applied to Real Life-A Multicenter Analysis of Stroke Patients Undergoing Endovascular Treatment in Clinical Practice.,"Background Randomized controlled clinical trials (RCT) have demonstrated the efficacy of endovascular treatment in anterior circulation large vessel occlusions. However, outcome of patients treated in daily practice differs from the results of the clinical trials. We hypothesize that this is attributable to the study criteria and that application of the criteria on patients undergoing endovascular therapy in daily routine would improve their outcome. Methods and Results Data from a multicenter prospective registry of GSR-ET (German Stroke Registry - Endovascular Treatment) was used. Inclusion criteria and selectivity of SWIFT-PRIME (Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment trial), MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands trial), ESCAPE (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times trial), DAWN (DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention with Trevo trial) and DEFUSE-3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke trial) trials were analyzed. Baseline characteristics, procedural and outcome data of patients from GSR-ET before and after selection were compared with the results of the RCTs. Furthermore, outcome of patients who underwent endovascular treatment despite not fulfilling the RCT criteria was analyzed. A total of 2611 patients were included (median age, 75 years; 49.6% women; median National Institute of Health Stroke Scale, 16). A minority of patients met all inclusion criteria, ranging from 3% (DEFUSE-3 criteria) to 35% (MR CLEAN criteria). Of the patients fulfilling the MR CLEAN criteria, 41% of patients had a good clinical outcome, compared with 34% of patients that did not fulfill MR CLEAN criteria. Conclusions The RCTs represent a selected population with higher rates of good clinical outcome compared with daily practice. The good outcomes of RCTs can be reproduced in clinical routine in patients who fulfill the RCT inclusion criteria. Furthermore, patients who did not meet the criteria of the RCT still had substantial rates of good clinical outcome.",2021,"Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands trial), ESCAPE (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times trial), DAWN (DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention with Trevo trial) and DEFUSE-3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke trial) trials were analyzed.","['Stroke Patients Undergoing Endovascular Treatment in Clinical Practice', 'A total of 2611 patients were included (median age, 75\xa0years; 49.6% women; median National Institute of Health Stroke Scale, 16', 'anterior circulation large vessel occlusions']","['DEFUSE-3 (Endovascular Therapy', 'ESCAPE (Endovascular Treatment', 'MR CLEAN ', 'Endovascular Treatment', 'DAWN (DWI or CTP Assessment with Clinical Mismatch', 'RCTs']",[],"[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0598801', 'cui_str': 'Diffusion weighted magnetic resonance imaging'}, {'cui': 'C0010734', 'cui_str': 'Cytidine triphosphate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",[],2611.0,0.242212,"Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands trial), ESCAPE (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times trial), DAWN (DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention with Trevo trial) and DEFUSE-3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke trial) trials were analyzed.","[{'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Leischner', 'Affiliation': 'Department of Neuroradiological Diagnostics and Intervention University Medical Center Hamburg-Eppendorf Hamburg Germany.'}, {'ForeName': 'Caspar', 'Initials': 'C', 'LastName': 'Brekenfeld', 'Affiliation': 'Department of Neuroradiological Diagnostics and Intervention University Medical Center Hamburg-Eppendorf Hamburg Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'Department of Neuroradiological Diagnostics and Intervention University Medical Center Hamburg-Eppendorf Hamburg Germany.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Broocks', 'Affiliation': 'Department of Neuroradiological Diagnostics and Intervention University Medical Center Hamburg-Eppendorf Hamburg Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Faizy', 'Affiliation': 'Department of Neuroradiological Diagnostics and Intervention University Medical Center Hamburg-Eppendorf Hamburg Germany.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'McDonough', 'Affiliation': 'Department of Neuroradiological Diagnostics and Intervention University Medical Center Hamburg-Eppendorf Hamburg Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerloff', 'Affiliation': 'Department of Neurology University Medical Center Hamburg-Eppendorf Hamburg Germany.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Thomalla', 'Affiliation': 'Department of Neurology University Medical Center Hamburg-Eppendorf Hamburg Germany.'}, {'ForeName': 'Milani', 'Initials': 'M', 'LastName': 'Deb-Chatterji', 'Affiliation': 'Department of Neurology University Medical Center Hamburg-Eppendorf Hamburg Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Fiehler', 'Affiliation': 'Department of Neuroradiological Diagnostics and Intervention University Medical Center Hamburg-Eppendorf Hamburg Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Flottmann', 'Affiliation': 'Department of Neuroradiological Diagnostics and Intervention University Medical Center Hamburg-Eppendorf Hamburg Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.120.017919']
1276,34784589,Oral Wheat Immunotherapy: Long-Term Follow-Up in Children with Wheat Anaphylaxis.,"INTRODUCTION


There has been substantial increase in food allergies in recent decades. The management of severe food allergy often includes strict avoidance and medical therapies. However, oral immunotherapy (OIT) is a promising treatment option for these patients, which is still being investigated.
METHODS


The study recruited children from 2 years onward with a history of wheat anaphylaxis who had been referred to the Mofid Children Hospital. Wheat allergy was confirmed by a double-blind placebo-controlled food challenge. OIT was started to reach 5.28 g of wheat protein supplied in 60 g of bread. Besides immunologic measurements, a second and third oral food challenge (OFC) was performed after 3 months and 1 year of maintenance therapy to evaluate the long-term efficacy of wheat OIT (WOIT).
RESULTS


Seventeen patients completed the 3-month maintenance phase; 8 of them demonstrated negative OFCs. All of the 9 with positive OFCs were asked to continue the daily consumption of 60 g of bread for another year. Three patients with positive OFCs were followed for 1 more year and were asked to continue eating 60 g of bread every other day. The serum level of wheat sIgE was significantly increased at the end of the buildup phase (p = 0.026) and dramatically dropped at the end of the maintenance phase (p = 0.022).
CONCLUSION


To conclude, WOIT is an effective and safe modality of treatment if it is administered under strict supervision.",2022,"The serum level of wheat sIgE was significantly increased at the end of the buildup phase (p = 0.026) and dramatically dropped at the end of the maintenance phase (p = 0.022).
","['Children with Wheat Anaphylaxis', 'study recruited children from 2 years onward with a history of wheat anaphylaxis who had been referred to the Mofid Children Hospital']","['oral immunotherapy (OIT', 'Oral Wheat Immunotherapy', 'wheat OIT (WOIT']",['serum level of wheat sIgE'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}]",3.0,0.101651,"The serum level of wheat sIgE was significantly increased at the end of the buildup phase (p = 0.026) and dramatically dropped at the end of the maintenance phase (p = 0.022).
","[{'ForeName': 'Delara', 'Initials': 'D', 'LastName': 'Babaie', 'Affiliation': ""Department of Allergy and Clinical Immunology, Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Ebisawa', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization, Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Soheili', 'Affiliation': 'Department of Allergy and Immunology, Medical Center Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Ghasemi', 'Affiliation': 'Allergy Clinic, Isabne-Maryam Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Zandieh', 'Affiliation': 'Department of Pediatric Allergy and Immunology, Bahrami Children Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Sahragard', 'Affiliation': 'Department of Pediatrics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Seifi', 'Affiliation': ""Department of Allergy and Clinical Immunology, Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mazdak', 'Initials': 'M', 'LastName': 'Fallahi', 'Affiliation': ""Department of Allergy and Clinical Immunology, Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Khoshmirsafa', 'Affiliation': 'Immunology Department, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Darougar', 'Affiliation': 'Department of Pediatrics, Tehran Medical Sciences Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Mehrnaz', 'Initials': 'M', 'LastName': 'Mesdaghi', 'Affiliation': ""Department of Allergy and Clinical Immunology, Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}]",International archives of allergy and immunology,['10.1159/000519692']
1277,34787719,Longitudinal craze line propagation in human root dentin after instrumentation with NiTi rotary files of different instrument tapers after long-term chewing simulation.,"OBJECTIVES


The aim of this study was to investigate whether file design and taper significantly influence microcrack initiation during machine preparation.
MATERIALS AND METHODS


Sixty extracted teeth with straight single canals were selected. The teeth were randomly assigned to four groups based on their root canal anatomy and the corresponding NiTi rotary file system (I, Mtwo; II, ProTaper Universal; III, F6 SkyTaper; control, no preparation and filling). The root canals of the experimental groups were filled using the single-cone technique. The tested teeth were all subjected to a mechanical chewing simulation with flat lead loading over a period of 3 years (corresponding to 150,000 cycles). The teeth were checked for dentinal defects (accumulative crack growth in length) under the digital microscope (Keyence VHX-5000) at time 0 (baseline prior to chewing simulation) and after 3, 6, 12, 24, and 36 months of loading. The cumulative crack increase was statistically analyzed using the Kruskal-Wallis test, Jonckheere-Terpstra test, and the Wilcoxon rank-sum test. The significance was set at p < 0.05.
RESULTS


In contrast to preparation with greater-tapered instruments, ProTaper Universal (group II) and F6 SkyTaper (group III) instrumentation with the smaller tapered Mtwo files (group I) showed less accumulative propagation of craze lines (p < 0.05) at all time points.
CONCLUSION


Instruments with greater taper for root canal instrumentation should be used with care to avoid negative long-term effects in the form of propagation of dentinal defects over time. A positive cutting-edge angle and a smaller taper have a positive effect on a lower craze line development.
CLINICAL RELEVANCE


Instruments with a positive cutting-edge angle and a smaller taper are beneficial for the long-term preservation of dentinal tooth structure.",2022,"The cumulative crack increase was statistically analyzed using the Kruskal-Wallis test, Jonckheere-Terpstra test, and the Wilcoxon rank-sum test.","['human root dentin after instrumentation with NiTi rotary files of different instrument tapers after long-term chewing simulation', 'Sixty extracted teeth with straight single canals were selected']","['root canal anatomy and the corresponding NiTi rotary file system (I, Mtwo; II, ProTaper Universal; III, F6 SkyTaper; control, no preparation and filling']","['accumulative propagation of craze lines', 'cumulative crack increase']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}]","[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0040441', 'cui_str': 'Fracture of tooth'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",60.0,0.0255959,"The cumulative crack increase was statistically analyzed using the Kruskal-Wallis test, Jonckheere-Terpstra test, and the Wilcoxon rank-sum test.","[{'ForeName': 'Marie-Therese', 'Initials': 'MT', 'LastName': 'Heberer', 'Affiliation': 'Department of Operative Dentistry, Endodontics, and Pediatric Dentistry, Philipps University Marburg and University Hospital Giessen and Marburg, Campus Marburg, Georg-Voigt-Straße 3, 35039, Marburg, Germany. heberer.med@gmx.de.'}, {'ForeName': 'Hubert C', 'Initials': 'HC', 'LastName': 'Roggendorf', 'Affiliation': 'Interdisciplinary Department of Oral Surgery an Implantology, University of Cologne, Kerpener Straße 32, 50931, Cologne, Germany.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Faber', 'Affiliation': 'Pre-Clinical Department, University of Cologne, Kerpener Straße 32, 50931, Cologne, Germany.'}, {'ForeName': 'Nicolai-Alexander', 'Initials': 'NA', 'LastName': 'Lawrenz', 'Affiliation': 'Department of Mathematics and Computer Science, Philipps University of Marburg, Hans-Meerwein-Straße 6, 35043, Marburg, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Frankenberger', 'Affiliation': 'Department of Operative Dentistry, Endodontics, and Pediatric Dentistry, Philipps University Marburg and University Hospital Giessen and Marburg, Campus Marburg, Georg-Voigt-Straße 3, 35039, Marburg, Germany.'}, {'ForeName': 'Matthias J', 'Initials': 'MJ', 'LastName': 'Roggendorf', 'Affiliation': 'Department of Operative Dentistry, Endodontics, and Pediatric Dentistry, Philipps University Marburg and University Hospital Giessen and Marburg, Campus Marburg, Georg-Voigt-Straße 3, 35039, Marburg, Germany.'}]",Clinical oral investigations,['10.1007/s00784-021-04238-3']
1278,34787718,The comparison of the efficacy of gingival unit graft with connective tissue graft in recession defect coverage: a randomized split-mouth clinical trial.,"OBJECTIVES


Gingival unit graft (GUG) is defined as the modified form of free gingival graft. The aim of this study is to compare the clinical efficacy of GUG with connective tissue graft (SCTG) with respect to clinical periodontal parameters and patient comfort scores in gingival recessions.
MATERIALS AND METHODS


Sixteen patients with bilateral recession type 1 (RT1) gingival recessions participated in this randomized and split-mouth study. Thirty-two defects received surgical treatment with SCTG or GUG. The recession defect coverage, periodontal measurements, and patient-reported outcomes (intra- and post-operative patient comfort, aesthetic satisfaction, and hypersensitivity) were evaluated at baseline and post-operative months 1, 3 and 6.
RESULTS


The favorable results were obtained in both study groups in gingival recession depth (RD), gingival recession width (RW), clinical attachment level (CAL), and keratinized tissue width (KTW). The average percentages of the recession defect coverage (RC) for GUG and SCTG group treatments after 6 months were 68.2 ± 33% and 76.4 ± 30.2%, respectively (p > 0.05). Although there was no significant difference between groups at post-operative 6 months (p > 0.05) in terms of RD, RW, CAL, RC, patient comfort, aesthetic satisfaction, and hypersensitivity parameters, the increase in KTW was significantly higher in GUG group (p < 0.05).
CONCLUSIONS


It was concluded that although both techniques were effective, GUG can be a convenient method for treatment of RT1 gingival recessions with inadequate KTW and (or) shallow vestibule depth.
CLINICAL RELEVANCE


According to the results of this study, GUG may be a preferred choice in localized gingival recessions with a lack of keratinized tissue. The trial registration number: NCT04637451.",2022,"The favorable results were obtained in both study groups in gingival recession depth (RD), gingival recession width (RW), clinical attachment level (CAL), and keratinized tissue width (KTW).","['Sixteen patients with bilateral recession type 1 (RT1) gingival recessions participated in this randomized and split-mouth study', 'recession defect coverage']","['gingival unit graft with connective tissue graft', 'surgical treatment with SCTG or GUG', 'GUG with connective tissue graft (SCTG']","['RD, RW, CAL, RC, patient comfort, aesthetic satisfaction, and hypersensitivity parameters', 'recession defect coverage (RC', 'KTW', 'gingival recession depth (RD), gingival recession width (RW), clinical attachment level (CAL), and keratinized tissue width (KTW', 'recession defect coverage, periodontal measurements, and patient-reported outcomes (intra- and post-operative patient comfort, aesthetic satisfaction, and hypersensitivity']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",16.0,0.0228654,"The favorable results were obtained in both study groups in gingival recession depth (RD), gingival recession width (RW), clinical attachment level (CAL), and keratinized tissue width (KTW).","[{'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Kayaalti-Yüksek', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Istanbul Okan University, Istanbul, Turkey. sibelkayaalti@hotmail.com.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Yaprak', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Kocaeli University, Kocaeli, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-021-04252-5']
1279,34788698,Association of Short-Term Patient-Reported Outcomes With Long-Term Oncologic Outcomes in Localized Prostate Cancer Patients Treated With Radiation Therapy and Androgen Deprivation Therapy in a Randomized Controlled Trial.,"PURPOSE


Both oncologic outcomes and patient-reported outcomes are pivotal in prostate cancer (PCa). However, it remains unknown if there is any association between these 2 outcomes. In this secondary analysis of a randomized controlled trial, we investigated the association of short-term changes in patient-reported outcome with long-term event-free survival (EFS) and metastasis-free survival (MFS) in localized PCa.
METHODS AND MATERIALS


Localized PCa patients with a Gleason score ≤7, clinical stage T1b to T3a, and prostate-specific antigen (PSA) <30 ng/mL were randomized to neoadjuvant and concurrent androgen deprivation therapy (ADT) for 6 months starting 4 months before prostate radiation therapy or concurrent and adjuvant ADT for 6 months starting simultaneously with radiation therapy. Patient-reported symptom burden was evaluated using the European Organisation for Research and Treatment of Cancer quality of life questionnaire (QLQ)-PR.25. Clinically meaningful deterioration (CMD) was defined as a ≥10-point worsening at any time within 10 months postrandomization regardless of subsequent improvement. Landmark analyses were performed to determine the association of CMD of urinary and bowel symptoms separately with EFS and MFS in patients who responded to the baseline questionnaire, were alive, and were event free at 10 months.
RESULTS


Overall, 393 patients had responded to the baseline QLQ. One patient died, and 1 patient had failure within 10 months. Therefore, 391 patients were eligible for the landmark analyses. After adjusting for age, Gleason score, PSA, performance status, and treatment group, CMD of urinary symptoms was associated with worse EFS (hazard ratio [HR], 1.79; 95% confidence interval [CI], 1.21-2.65) and MFS (HR, 1.69; 95% CI, 1.11-2.57). Considering deaths as competing events, CMD of urinary symptoms was associated with a significant increase in the relative incidence of progression (subdistribution HR, 2.42; 95% CI, 1.12-5.20). However, no association was found between CMD of bowel symptoms and EFS or MFS.
CONCLUSIONS


In this study, short-term CMD of urinary symptoms was associated with significantly inferior EFS and MFS and an increase in the relative incidence of progression. Further investigations are needed to explore the biological rationale of such association in the context of ADT and radiation therapy.",2022,"Considering deaths as competing events, CMD of urinary symptoms was associated with a significant increase in the relative incidence of progression (subdistribution HR: 2.42, 95%CI: 1.12-5.20).","['391 patients were eligible for the landmark analyses', 'Localized Prostate Cancer Patients Treated with', 'Localized PCa patients with Gleason score ≤7, clinical stage T1b-T3a, and PSA <30 ng/mL', '393 patients had responded to baseline QoL questionnaire']","['Radiotherapy and ADT', 'prostate radiotherapy or concurrent and adjuvant ADT for 6 months starting simultaneously with radiotherapy', 'neoadjuvant and concurrent ADT']","['Clinically meaningful deterioration (CMD', 'CMD of urinary symptoms', 'CMD of bowel symptoms and EFS or MFS', 'long-term event-free survival (EFS) and metastasis-free survival (MFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0475385', 'cui_str': 'Tumor stage T1b'}, {'cui': 'C0475390', 'cui_str': 'Tumor stage T3a'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0948317', 'cui_str': 'Radiotherapy to prostate'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",391.0,0.498799,"Considering deaths as competing events, CMD of urinary symptoms was associated with a significant increase in the relative incidence of progression (subdistribution HR: 2.42, 95%CI: 1.12-5.20).","[{'ForeName': 'Soumyajit', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois. Electronic address: soumyajitroy8@gmail.com.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'University Hospitals Seidman Cancer Center, Cleveland, Ohio.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Morgan', 'Affiliation': 'The Ottawa Hospital Cancer Centre, University of Ottawa.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Leah A', 'Initials': 'LA', 'LastName': ""D'Souza"", 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Fletcher', 'Initials': 'F', 'LastName': 'Drogos', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Malone', 'Affiliation': 'The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Grimes', 'Affiliation': 'The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gualano', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'MacRae', 'Affiliation': 'The Ottawa Hospital Cancer Centre, University of Ottawa.'}, {'ForeName': 'Dibya', 'Initials': 'D', 'LastName': 'Mukherjee', 'Affiliation': 'The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Malone', 'Affiliation': 'The Ottawa Hospital Cancer Centre, University of Ottawa. Electronic address: smalone@toh.ca.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.11.010']
1280,34789394,Patient Preference Between Cabazitaxel and Docetaxel for First-line Chemotherapy in Metastatic Castration-resistant Prostate Cancer: The CABADOC Trial.,"BACKGROUND


The taxanes docetaxel and cabazitaxel prolong overall survival for men with metastatic castration-resistant prostate cancer (mCRPC), with cabazitaxel approved in the postdocetaxel setting only. Recent data suggest they have similar efficacy but a different safety profile in the first-line mCRPC setting.
OBJECTIVE


To assess patient preference between docetaxel and cabazitaxel among men who received one or more doses of each taxane and did not experience progression after the first taxane.
DESIGN, SETTING, AND PARTICIPANTS


Chemotherapy-naïve patients with mCRPC were randomized 1:1 to receive docetaxel (75 mg/m 2  every 3 wk × 4 cycles) followed by cabazitaxel (25 mg/m 2  every 3 wk × 4 cycles) or the reverse sequence. Randomization was stratified by prior abiraterone or enzalutamide use.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was patient preference, assessed via a dedicated questionnaire after the second taxane. Secondary endpoints included reasons for patient preference, prostate-specific antigen response, radiological progression-free survival, and overall survival. This clinical trial is registered at ClinicalTrials.gov as NCT02044354.
RESULTS AND LIMITATIONS


Of 195 men randomized, 152 met the prespecified modified intent-to-treat criteria for analysis. Overall, 66 patients (43%) preferred cabazitaxel, 40 (27%) preferred docetaxel, and 46 (30%) had no preference (p = 0.004, adjusted for treatment period effect). More patients preferred treatment period 1 (43%, 95% confidence interval [CI] 36-52%) versus period 2 (27%, 95% CI 20-34%). Patient preference for cabazitaxel was mainly related to less fatigue (72%), better quality of life (64%), and other adverse events (hair loss, pain, nail disorders, edema). Adverse events were consistent with the known safety profile of each drug.
CONCLUSIONS


A significantly higher proportion of chemotherapy-naïve men with mCRPC who received both taxanes preferred cabazitaxel over docetaxel. Less fatigue and better quality of life were the two main reasons driving patient choice.
PATIENT SUMMARY


Men with metastatic castration-resistant prostate cancer preferred cabazitaxel over docetaxel for chemotherapy, mainly because of less fatigue and better quality of life.",2022,"More patients preferred treatment period 1 (43%, 95% confidence interval [CI] 36-52%) versus period 2 (27%, 95% CI 20-34%).","['Chemotherapy-naïve patients with mCRPC', 'men with metastatic castration-resistant prostate cancer (mCRPC', 'Of 195 men randomized', 'men who received one or more doses of each taxane and did not experience progression after the first taxane', 'Men with metastatic castration-resistant prostate cancer', 'Metastatic Castration-resistant Prostate Cancer']","['docetaxel', 'cabazitaxel', 'taxanes docetaxel and cabazitaxel', 'Cabazitaxel and Docetaxel', 'docetaxel and cabazitaxel']","['quality of life', 'Adverse events', 'patient preference, assessed via a dedicated questionnaire', 'fatigue', 'adverse events (hair loss, pain, nail disorders, edema', 'reasons for patient preference, prostate-specific antigen response, radiological progression-free survival, and overall survival', 'Less fatigue and better quality of life', 'overall survival']","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027339', 'cui_str': 'Disorder of nail'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",195.0,0.439932,"More patients preferred treatment period 1 (43%, 95% confidence interval [CI] 36-52%) versus period 2 (27%, 95% CI 20-34%).","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Baciarello', 'Affiliation': 'Department of Cancer Medicine, Gustave Roussy, University of Paris Saclay, Villejuif, France.'}, {'ForeName': 'Remy', 'Initials': 'R', 'LastName': 'Delva', 'Affiliation': ""Institut de Cancerologie de l'Ouest, Angers, France.""}, {'ForeName': 'Gwenaelle', 'Initials': 'G', 'LastName': 'Gravis', 'Affiliation': 'Medical Oncology, Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Tazi', 'Affiliation': 'Strasbourg Oncologie Libérale, Strasbourg, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Beuzeboc', 'Affiliation': 'Hospital Foch, Suresnes, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Gross-Goupil', 'Affiliation': 'Oncology Department, Centre Hospitalier Universitaire Saint-Andre, Bordeaux, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Bompas', 'Affiliation': 'Centre René Gauducheau, Nantes, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'GINECO and Regional Centre Control Against Cancer Francois Baclesse, Caen, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Greilsamer', 'Affiliation': 'GINECO-Centre Hospitalier Départemental Vendée Les Oudairies, La Roche-Sur-Yon, France.'}, {'ForeName': 'Thierry Nguyen Tan', 'Initials': 'TNT', 'LastName': 'Hon', 'Affiliation': 'Hôpital Jean Minjoz, Besancon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Barthelemy', 'Affiliation': 'Medical Oncology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Culine', 'Affiliation': 'Hospital Saint-Louis, Paris, France.'}, {'ForeName': 'Jean Francois', 'Initials': 'JF', 'LastName': 'Berdah', 'Affiliation': 'Clinique Sainte Marguerite, Hyères, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Deblock', 'Affiliation': 'Institut de Cancerologie de Lorraine, Vandœuvre-Les-Nancy, France.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Ratta', 'Affiliation': 'Hospital Foch, Suresnes, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Flechon', 'Affiliation': 'Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Cheneau', 'Affiliation': 'CHU Brest, Brest, France.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Maillard', 'Affiliation': 'Department of Biostatistics and Epidemiology, Gustave Roussy, University Paris-Saclay, Univerity Paris-Sud, Villejuif, France.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Martineau', 'Affiliation': 'Clinical Research Department, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Borget', 'Affiliation': 'Department of Biostatistics and Epidemiology, Gustave Roussy, University Paris-Saclay, Univerity Paris-Sud, Villejuif, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Department of Cancer Medicine, Gustave Roussy, University of Paris Saclay, Villejuif, France. Electronic address: karim.fizazi@gustaveroussy.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2021.10.016']
1281,34791296,Bone changes with candidate PrEP regimens containing tenofovir disoproxil fumarate and/or maraviroc and/or emtricitabine in US men and women: HPTN 069/ACTG A5305.,"BACKGROUND


Tenofovir disoproxil fumarate-containing pre-exposure prophylaxis (PrEP) has been associated with decreases in bone mineral density (BMD), but the bone effects of other non-tenofovir disoproxil fumarate candidate PrEP regimens are not well described.
METHODS


The HPTN 069/ACTG A5305 study randomized 406 US cisgender men and transgender women, and 188 cisgender women at risk for HIV infection to one of four double-blinded regimens: (i) maraviroc; (ii) maraviroc + emtricitabine; (iii) maraviroc + tenofovir disoproxil fumarate; or (iv) tenofovir disoproxil fumarate + emtricitabine. BMD was measured in a subset of participants at the lumbar spine (LS) and hip by dual-energy X-ray absorptiometry (DXA) at baseline and 48 weeks. Percentage change in LS and hip BMD was compared between the tenofovir disoproxil fumarate- and non-tenofovir disoproxil fumarate-containing arms by Wilcoxon rank-sum tests and multiple linear regression adjusting for sex, race and baseline BMI.
RESULTS


At baseline (n = 307), the median age was 33 years, 56% male and 43% black. At the hip, the median percentage change in BMD at 48 weeks was -1.05% in the tenofovir disoproxil fumarate arms and 0.0% in the non-tenofovir disoproxil fumarate arms (between group P = 0.001). No interaction by sex was observed. The median percentage change in LS BMD was not different between arms.
CONCLUSIONS


Tenofovir disoproxil fumarate-containing PrEP was associated with significantly greater bone loss compared with maraviroc ± emtricitabine PrEP at the hip, but not the LS. The BMD changes at the hip were similar in magnitude in men and women.",2022,"Tenofovir disoproxil fumarate-containing PrEP was associated with significantly greater bone loss compared with maraviroc ± emtricitabine PrEP at the hip, but not the LS.","['A5305 study randomized 406 US cisgender men and transgender women, and 188 cisgender women at risk for HIV infection to one of four double-blinded regimens: (i', 'US men and women', 'At baseline (n = 307), the median age was 33 years, 56% male and 43% black']","['maraviroc; (ii) maraviroc + emtricitabine; (iii', 'tenofovir disoproxil fumarate and/or maraviroc and/or emtricitabine', 'HPTN 069/ACTG', 'tenofovir disoproxil fumarate- and non-tenofovir disoproxil fumarate', 'tenofovir disoproxil fumarate + emtricitabine', 'maraviroc + tenofovir disoproxil fumarate', 'Tenofovir disoproxil fumarate-containing pre-exposure prophylaxis (PrEP', 'tenofovir disoproxil fumarate', 'Tenofovir disoproxil fumarate-containing PrEP']","['BMD', 'bone mineral density (BMD', 'BMD changes', 'bone loss', 'LS and hip BMD', 'LS BMD']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C1667052', 'cui_str': 'maraviroc'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",406.0,0.0952702,"Tenofovir disoproxil fumarate-containing PrEP was associated with significantly greater bone loss compared with maraviroc ± emtricitabine PrEP at the hip, but not the LS.","[{'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Yuhas', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention (SCHARP), Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Mayer', 'Affiliation': 'Fenway Health, Department of Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA 02215, USA.'}, {'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'Landovitz', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, Los Angeles,, CA 90025, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'Ying Q', 'Initials': 'YQ', 'LastName': 'Chen', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention (SCHARP), Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Klingman', 'Affiliation': 'HIV Research Branch, Therapeutics Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Wairimu', 'Initials': 'W', 'LastName': 'Chege', 'Affiliation': 'Clinical Prevention Research Branch, Prevention Sciences Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Marybeth B', 'Initials': 'MB', 'LastName': 'Mccauley', 'Affiliation': 'FHI 360, 1825 Connecticut Avenue NW, Washington, DC 20009, USA.'}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Gulick', 'Affiliation': 'Department of Medicine, Weill, Cornell, Medicine, New York, NY 10065, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Wilkin', 'Affiliation': 'Department of Medicine, Weill, Cornell, Medicine, New York, NY 10065, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkab400']
1282,34799518,An Interprofessional Group Intervention to Promote Faculty Well-Being: A Randomized Clinical Trial.,"INTRODUCTION


To evaluate the effect on engagement, relational connection, and burnout of an intervention involving clinical faculty meeting in interprofessional self-facilitated groups and to determine whether a written discussion guide is necessary to achieve benefit.
METHODS


This is a randomized controlled trial, conducted at a large US academic medical center from May to August 2018. Subjects included 25 clinical physicians, nurse practitioners, and certified nurse midwives. The intervention involved three monthly self-facilitated groups for faculty. Groups were randomized to have no discussion guide, or to receive a one-page guide. Outcomes of burnout, engagement, and empowerment in work, and stress from uncertainty were assessed using validated metrics.
RESULTS


Rates of emotional exhaustion and depersonalization decreased significantly over the course of the 3-month study (56%-36%; P < .001; and 20%-15%; P = .006) and overall burnout decreased from 56% to 41% of faculty (P = .002). The percentage of faculty who felt engaged in their work increased from 80% to 96% (P = .03). No statistically significant differences in empowerment at work or in reaction to uncertainty were seen. The groups without a discussion guide had equivalent outcomes and benefits. Cost per participant was under $100.
DISCUSSION


A three-month, low-cost, self-facilitated series of dinner meetings for interprofessional clinical faculty decreased burnout and improved engagement, sense of connection to colleagues, and sense of departmental commitment to well-being. Structured discussion guides were not necessary to achieve benefit. This study broadens the possibilities for cost-effective opportunities to transform institutional culture and effectively enhance faculty well-being.",2022,The percentage of faculty who felt engaged in their work increased from 80% to 96% (P = .03).,"['Subjects included 25 clinical physicians, nurse practitioners, and certified nurse midwives']",[],"['overall burnout', 'percentage of faculty who felt engaged in their work', 'Rates of emotional exhaustion and depersonalization', 'Outcomes of burnout, engagement, and empowerment in work, and stress from uncertainty', 'empowerment at work or in reaction to uncertainty']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0028655', 'cui_str': 'Nurse-Midwife'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0011551', 'cui_str': 'Depersonalization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.100651,The percentage of faculty who felt engaged in their work increased from 80% to 96% (P = .03).,"[{'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Hata', 'Affiliation': 'Dr. Hata: Assistant Professor, Department of Medicine, Harvard Medical School, Massachusetts General Hospital, Boston, MA, Department of Medicine, Massachusetts General Hospital, Boston, MA, and Harvard Medical School, Boston, MA. Dr. Berkowitz: Harvard Medical School, Boston, MA and Vice Chair of Education and Wellness, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA. Dr. James: Epidemiologist, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA. Dr. Simpkin: Assistant Professor, Department of Medicine, Massachusetts General Hospital, Boston, MA, Harvard Medical School, Boston, MA, and Department of Pharmacology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lori R', 'Initials': 'LR', 'LastName': 'Berkowitz', 'Affiliation': ''}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'James', 'Affiliation': ''}, {'ForeName': 'Arabella L', 'Initials': 'AL', 'LastName': 'Simpkin', 'Affiliation': ''}]",The Journal of continuing education in the health professions,['10.1097/CEH.0000000000000404']
1283,34774639,Sebelipase alfa in children and adults with lysosomal acid lipase deficiency: Final results of the ARISE study.,"BACKGROUND & AIMS


Children and adults with lysosomal acid lipase deficiency (LAL-D) experience cirrhosis and dyslipidemia from lysosomal accumulation of cholesteryl esters and triglycerides. Sebelipase alfa enzyme replacement therapy is indicated for individuals with LAL-D. We report final results from the phase III randomized ARISE study of sebelipase alfa in children aged ≥4 years and adults with LAL-D.
METHODS


The study included a 20-week, double-blind, placebo-controlled period; a 130-week, open-label, extension period; and a 104-week, open-label, expanded treatment period. In the open-label periods, all patients received intravenous sebelipase alfa every other week. The primary outcome was alanine aminotransferase (ALT) level normalization; aspartate aminotransferase (AST) levels, lipid parameters, liver histology, liver and spleen volume and fat content, and safety were also assessed.
RESULTS


Of 66 patients enrolled, 59 completed the study. Median (range) age at randomization was 13 (4.7-59) years. At the last open-label visit, ALT and AST levels had normalized in 47% and 66% of patients, respectively. Patients who switched from placebo to sebelipase alfa experienced sustained improvements in ALT and AST during the open-label periods that mirrored those observed in the sebelipase alfa group during the double-blind period. Median (IQR) percent changes in lipid levels included a 25% (39%, 6.5%) reduction in low-density lipoprotein cholesterol and a 27% (19%, 44%) increase in high-density lipoprotein cholesterol. Most adverse events during the open-label periods were mild to moderate in severity; 13 patients had infusion-associated reactions (serious in 1 patient). Six patients (9%) developed anti-drug antibodies.
CONCLUSIONS


Early and rapid improvements in markers of liver injury and lipid abnormalities with sebelipase alfa were sustained, with no progression of liver disease, for up to 5 years.
CLINICAL TRIAL NUMBER


NCT01757184; EudraCT Number: 2011-002750-31 LAY SUMMARY: Sebelipase alfa is used to treat lysosomal acid lipase deficiency (LAL-D), a rare, inherited disease of lipid metabolism. We report the final results of the phase III ARISE clinical study, which show that replacement of the defective LAL enzyme with sebelipase alfa for up to 5 years allows adults and children 4 years of age and older to maintain their initial improvements in liver and cholesterol parameters over the long term, without worsening of liver disease.",2022,Most adverse events during the open-label periods were mild to moderate in severity; 13 patients had infusion-associated reactions (serious in 1 patient).,"['66 patients enrolled', 'Children and adults with lysosomal acid lipase deficiency (LAL-D) experience cirrhosis and dyslipidemia from lysosomal accumulation of cholesteryl esters and triglycerides', 'individuals with LAL-D', 'children aged ≥4 years and adults with LAL-D.\nMETHODS']","['sebelipase alfa', 'Sebelipase alfa enzyme replacement therapy', 'placebo', 'intravenous sebelipase alfa']","['alanine aminotransferase (ALT) level normalization; aspartate aminotransferase (AST) levels, lipid parameters, liver histology, liver and spleen volume and fat content, and safety', 'low-density lipoprotein cholesterol', 'high-density lipoprotein cholesterol', 'anti-drug antibodies', 'ALT and AST', 'lipid levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043208', 'cui_str': ""Wolman's disease""}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0008387', 'cui_str': 'Cholesterol ester'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C4050579', 'cui_str': 'sebelipase alfa'}, {'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}]",66.0,0.0849724,Most adverse events during the open-label periods were mild to moderate in severity; 13 patients had infusion-associated reactions (serious in 1 patient).,"[{'ForeName': 'Barbara K', 'Initials': 'BK', 'LastName': 'Burton', 'Affiliation': ""Genetics, Birth Defects & Metabolism, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA. Electronic address: bburton@luriechildrens.org.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Feillet', 'Affiliation': ""Reference Center for Hereditary Metabolic Diseases, Centre Hospitalier Universitaire Brabois - Hôpital d'Enfants, Vandoeuvre-lès-Nancy, France.""}, {'ForeName': 'Katryn N', 'Initials': 'KN', 'LastName': 'Furuya', 'Affiliation': 'Department of Pediatrics, University of Wisconsin - Madison School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Marulkar', 'Affiliation': 'Clinical Development, Alexion, AstraZeneca Rare Disease, Boston, MA, USA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Balwani', 'Affiliation': 'Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Journal of hepatology,['10.1016/j.jhep.2021.10.026']
1284,34774538,Randomized Controlled-Feeding Study of Dietary Emulsifier Carboxymethylcellulose Reveals Detrimental Impacts on the Gut Microbiota and Metabolome.,"BACKGROUND & AIMS


Epidemiologic and murine studies suggest that dietary emulsifiers promote development of diseases associated with microbiota dysbiosis. Although the detrimental impact of these compounds on the intestinal microbiota and intestinal health have been demonstrated in animal and in vitro models, impact of these food additives in healthy humans remains poorly characterized.
METHODS


To examine this notion in humans, we performed a double-blind controlled-feeding study of the ubiquitous synthetic emulsifier carboxymethylcellulose (CMC) in which healthy adults consumed only emulsifier-free diets (n = 9) or an identical diet enriched with 15 g per day of CMC (n = 7) for 11 days.
RESULTS


Relative to control subjects, CMC consumption modestly increased postprandial abdominal discomfort and perturbed gut microbiota composition in a way that reduced its diversity. Moreover, CMC-fed subjects exhibited changes in the fecal metabolome, particularly reductions in short-chain fatty acids and free amino acids. Furthermore, we identified 2 subjects consuming CMC who exhibited increased microbiota encroachment into the normally sterile inner mucus layer, a central feature of gut inflammation, as well as stark alterations in microbiota composition.
CONCLUSIONS


These results support the notion that the broad use of CMC in processed foods may be contributing to increased prevalence of an array of chronic inflammatory diseases by altering the gut microbiome and metabolome (ClinicalTrials.gov, number NCT03440229).",2022,"RESULTS


Relative to control subjects, CMC consumption modestly increased postprandial abdominal discomfort and perturbed gut microbiota composition in a way that reduced its diversity.","['healthy adults consumed only emulsifier-free diets (n=9) or an', 'healthy humans']","['identical diet enriched with 15 grams per day of CMC', 'ubiquitous synthetic emulsifier carboxymethylcellulose (CMC', 'dietary emulsifier carboxymethylcellulose']","['short-chain fatty acids and free amino acids', 'gut microbiota and metabolome', 'postprandial abdominal discomfort and perturbed gut microbiota composition', 'fecal metabolome']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0007068', 'cui_str': 'Carboxymethylcellulose'}, {'cui': 'C0014018', 'cui_str': 'Emulsifyers'}]","[{'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}]",,0.157619,"RESULTS


Relative to control subjects, CMC consumption modestly increased postprandial abdominal discomfort and perturbed gut microbiota composition in a way that reduced its diversity.","[{'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Chassaing', 'Affiliation': 'INSERM U1016, team ""Mucosal microbiota in chronic inflammatory diseases,\'\' CNRS UMR 8104, Université de Paris, Paris, France. Electronic address: benoit.chassaing@inserm.fr.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Compher', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Brittaney', 'Initials': 'B', 'LastName': 'Bonhomme', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Center for Molecular Toxicology and Carcinogenesis, Department of Veterinary and Biomedical Sciences, Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Center for Molecular Toxicology and Carcinogenesis, Department of Veterinary and Biomedical Sciences, Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Walters', 'Affiliation': 'Department of Microbiome Science, Max Planck Institute for Developmental Biology, Tübingen, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Nessel', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Delaroque', 'Affiliation': 'INSERM U1016, team ""Mucosal microbiota in chronic inflammatory diseases,\'\' CNRS UMR 8104, Université de Paris, Paris, France.'}, {'ForeName': 'Fuhua', 'Initials': 'F', 'LastName': 'Hao', 'Affiliation': 'Center for Molecular Toxicology and Carcinogenesis, Department of Veterinary and Biomedical Sciences, Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gershuni', 'Affiliation': 'Department of Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Chau', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Ni', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Bewtra', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Albenberg', 'Affiliation': ""Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Bretin', 'Affiliation': 'Institute for Biomedical Sciences, Center for Inflammation, Immunity and Infection, Digestive Disease Research Group, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'McKeever', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Ley', 'Affiliation': 'Department of Microbiome Science, Max Planck Institute for Developmental Biology, Tübingen, Germany.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Patterson', 'Affiliation': 'Center for Molecular Toxicology and Carcinogenesis, Department of Veterinary and Biomedical Sciences, Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Wu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Gewirtz', 'Affiliation': 'Institute for Biomedical Sciences, Center for Inflammation, Immunity and Infection, Digestive Disease Research Group, Georgia State University, Atlanta, Georgia. Electronic address: agewirtz@gsu.edu.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Lewis', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: james.lewis@pennmedicine.upenn.edu.'}]",Gastroenterology,['10.1053/j.gastro.2021.11.006']
1285,34774467,Complications related to dental extractions in patients with chronic kidney failure undergoing hemodialysis: a pilot study.,"OBJECTIVE


To clinically assess socket healing after tooth extraction and the occurrence of intra- and postoperative complications in patients with chronic kidney failure (CKF) receiving hemodialysis (HD) by comparing them with a control group.
STUDY DESIGN


This prospective study involved 48 patients with CKF receiving HD (study group [SG]) and 29 participants without CKF (control group [CG]) undergoing tooth extractions. No prophylactic antibiotic was administered to the participants. One calibrated dentist evaluated all individuals at 3, 7, 21, and 60 days after the tooth extractions and assessed hemostasis time, occurrence of local or distant infection, epithelialization, and deposition of alveolar bone.
RESULTS


In the SG, 87 teeth were extracted through 65 interventions, and in the CG, 76 teeth were extracted through 36 interventions. Bleeding beyond 30 minutes was observed in 12 interventions (18.5%) in SG participants and was controlled with local hemostatic agents. Neither group had individuals presenting with postoperative infectious complications at the surgical site or at a distance. After 21 days, we observed delayed epithelialization in 29.9% (26 of 87) of the individuals in the SG compared with 3.9% (3 of 37) of those in the CG (P < .001). After 60 days, all the sockets were epithelialized and showing radiographic signs of alveolar bone neoformation.
CONCLUSIONS


Individuals with CKF receiving hemodialysis tend to heal well after dental extractions. They did not have an increased risk of infectious complications after simple tooth extractions, but they showed prolonged bleeding events more often than control subjects. Additional research studies using larger sample sizes of patients with CKF receiving hemodialysis are needed to confirm our findings.",2022,Bleeding beyond 30 minutes was observed in 12 interventions (18.5%) in SG participants and was controlled with local hemostatic agents.,"['patients with chronic kidney failure undergoing hemodialysis', 'patients with chronic kidney failure (CKF) receiving hemodialysis (HD) by comparing them with a control group', '48 patients with CKF receiving HD (study group [SG]) and 29 participants without CKF (control group [CG]) undergoing tooth extractions', 'patients with CKF receiving hemodialysis', 'Individuals with CKF receiving hemodialysis']",[],"['postoperative infectious complications', 'Bleeding', 'hemostasis time, occurrence of local or distant infection, epithelialization, and deposition of alveolar bone', 'delayed epithelialization', 'prolonged bleeding events', 'risk of infectious complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",48.0,0.0458999,Bleeding beyond 30 minutes was observed in 12 interventions (18.5%) in SG participants and was controlled with local hemostatic agents.,"[{'ForeName': 'Natália Silva', 'Initials': 'NS', 'LastName': 'Andrade', 'Affiliation': 'Department of Stomatology, University of Sao Paulo School of Dentistry, São Paulo, Brazil; Department of Dentistry, Federal University of Sergipe, Lagarto, Sergipe, Brazil.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Caliento', 'Affiliation': 'Department of Stomatology, University of Sao Paulo School of Dentistry, São Paulo, Brazil.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Sarmento', 'Affiliation': 'Department of Stomatology, University of Sao Paulo School of Dentistry, São Paulo, Brazil; Department of Dentistry, State University of Paraiba, Campina Grande, Paraíba, Brazil.'}, {'ForeName': 'Marília', 'Initials': 'M', 'LastName': 'Figueiredo', 'Affiliation': 'Department of Stomatology, University of Sao Paulo School of Dentistry, São Paulo, Brazil.'}, {'ForeName': 'Karem L', 'Initials': 'KL', 'LastName': 'Ortega', 'Affiliation': 'Department of Stomatology, University of Sao Paulo School of Dentistry, São Paulo, Brazil.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Gallottini', 'Affiliation': 'Department of Stomatology, University of Sao Paulo School of Dentistry, São Paulo, Brazil. Electronic address: mhcgmaga@usp.br.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2021.08.004']
1286,34779220,Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis: The AVATAR Trial.,"BACKGROUND


Surgical aortic valve replacement (SAVR) represents a class I indication in symptomatic patients with severe aortic stenosis (AS). However, indications for early SAVR in asymptomatic patients with severe AS and normal left ventricular function remain debated.
METHODS


The AVATAR trial (Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis) is an investigator-initiated international prospective randomized controlled trial that evaluated the safety and efficacy of early SAVR in the treatment of asymptomatic patients with severe AS, according to common criteria (valve area ≤1 cm 2  with aortic jet velocity >4 m/s or a mean transaortic gradient ≥40 mm Hg), and with normal left ventricular function. Negative exercise testing was mandatory for inclusion. The primary hypothesis was that early SAVR would reduce the primary composite end point of all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failure compared with a conservative strategy according to guidelines. The trial was designed as event-driven to reach a minimum of 35 prespecified events. The study was performed in 9 centers in 7 European countries.
RESULTS


Between June 2015 and September 2020, 157 patients (mean age, 67 years; 57% men) were randomly allocated to early surgery (n=78) or conservative treatment (n=79). Follow-up was completed in May 2021. Overall median follow-up was 32 months: 28 months in the early surgery group and 35 months in the conservative treatment group. There was a total of 39 events, 13 in early surgery and 26 in the conservative treatment group. In the early surgery group, 72 patients (92.3%) underwent SAVR with operative mortality of 1.4%. In an intention-to-treat analysis, patients randomized to early surgery had a significantly lower incidence of primary composite end point than those in the conservative arm (hazard ratio, 0.46 [95% CI, 0.23-0.90];  P =0.02). There was no statistical difference in secondary end points, including all-cause mortality, first heart failure hospitalizations, major bleeding, or thromboembolic complications, but trends were consistent with the primary outcome.
CONCLUSIONS


In asymptomatic patients with severe AS, early surgery reduced a primary composite of all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failure compared with conservative treatment. This randomized trial provides preliminary support for early SAVR once AS becomes severe, regardless of symptoms. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02436655.",2022,"There was no statistical difference in secondary endpoints, including all-cause mortality, first heart failure hospitalizations, major bleeding or thromboembolic complications, but trends were consistent with the primary outcome.  ","['symptomatic patients with severe aortic stenosis (AS', '9 centers in 7 European countries', 'Asymptomatic seveRe aortic stenosis (AVATAR', 'asymptomatic patients with severe AS, according to common criteria (valve area ≤1 cm 2  with aortic jet velocity', 'A symptomatic Seve R e Aortic Stenosis', '157 patients (mean age 67 years, 57 % men']","['Surgical aortic valve replacement (SAVR', 'Aortic Valve replAcemenT versus conservative treatment', 'early SAVR', 'conservative treatment']","['operative mortality', 'all-cause mortality, first heart failure hospitalizations, major bleeding or thromboembolic complications', 'cause death, acute myocardial infarction, stroke or unplanned hospitalization for heart failure', 'mean trans-aortic gradient']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}]",,0.164812,"There was no statistical difference in secondary endpoints, including all-cause mortality, first heart failure hospitalizations, major bleeding or thromboembolic complications, but trends were consistent with the primary outcome.  ","[{'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Banovic', 'Affiliation': 'Belgrade Medical School, University of Belgrade, Serbia (M.B., S.P.).'}, {'ForeName': 'Svetozar', 'Initials': 'S', 'LastName': 'Putnik', 'Affiliation': 'Belgrade Medical School, University of Belgrade, Serbia (M.B., S.P.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Penicka', 'Affiliation': 'Cardiovascular Center, OLV Hospital, Aalst, Belgium (M.P., G.V.C., J.B.).'}, {'ForeName': 'Gheorghe', 'Initials': 'G', 'LastName': 'Doros', 'Affiliation': 'Boston University School of Public Health, Department of Biostatistics, MA (G.D.).'}, {'ForeName': 'Marek A', 'Initials': 'MA', 'LastName': 'Deja', 'Affiliation': 'Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland (M.A.D.).'}, {'ForeName': 'Radka', 'Initials': 'R', 'LastName': 'Kockova', 'Affiliation': 'Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic (R.K., M.K.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kotrc', 'Affiliation': 'Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic (R.K., M.K.).'}, {'ForeName': 'Sigita', 'Initials': 'S', 'LastName': 'Glaveckaite', 'Affiliation': 'Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Lithuania (S.G.).'}, {'ForeName': 'Hrvoje', 'Initials': 'H', 'LastName': 'Gasparovic', 'Affiliation': 'Department of Cardiac Surgery, University of Zagreb School of Medicine and University Hospital Center Zagreb, Croatia (H.G.).'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Pavlovic', 'Affiliation': 'University Hospital Center Sestre Milosrdnice, Zagreb, Croatia (N.P.).'}, {'ForeName': 'Lazar', 'Initials': 'L', 'LastName': 'Velicki', 'Affiliation': 'Faculty of Medicine, University of Novi Sad, Serbia (L.V.).'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Salizzoni', 'Affiliation': 'Division of Cardiosurgery, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital and University of Turin, Italy (S.S.).'}, {'ForeName': 'Wojtek', 'Initials': 'W', 'LastName': 'Wojakowski', 'Affiliation': 'Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland (W.W.).'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Van Camp', 'Affiliation': 'Cardiovascular Center, OLV Hospital, Aalst, Belgium (M.P., G.V.C., J.B.).'}, {'ForeName': 'Serge D', 'Initials': 'SD', 'LastName': 'Nikolic', 'Affiliation': 'CorDynamix, Redwood City, CA (S.N.D.).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Iung', 'Affiliation': 'Cardiology Department, Bichat Hospital APHP and Universite de Paris, France (B.I.).'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Bartunek', 'Affiliation': 'Cardiovascular Center, OLV Hospital, Aalst, Belgium (M.P., G.V.C., J.B.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.121.057639']
1287,34783452,Phase 1 Maximal Use Pharmacokinetic Study of Tirbanibulin Ointment 1% in Subjects With Actinic Keratosis.,"Tirbanibulin is a novel tubulin polymerization and Src kinase signaling inhibitor. This study was designed to fully characterize tirbanibulin pharmacokinetics (PK) when applied topically under maximal use conditions. This was an open-label, parallel-group PK safety study of tirbanibulin ointment 1% applied to 25 cm 2  of the face or balding scalp in adults with actinic keratosis (AK). Eligible subjects self-applied tirbanibulin once-daily for 5 days. PK sampling occurred on days 1, 3 and 4 at 0 hour (before dosing), and on day 5 at prespecified time points up to 24 hours after application. Safety assessments included adverse events and local skin reactions were evaluated up to day 29. Eighteen subjects (face or scalp, n = 9 each) completed the study. Subjects were White (100%), of mean [range] age 66.4 [43-83] years, predominantly men (83.3%) with Fitzpatrick skin type I to III (94.4%); baseline AK lesion count, mean [range] 8.2 [6-14]. All subjects had quantifiable but low plasma concentrations of tirbanibulin. On day 5, overall mean (standard deviation) maximum concentration (C max  ) was 0.26 (0.23) ng/mL (or 0.60 nM), median time to maximum concentration was 6.91 hours, and mean (standard deviation) area under the plasma concentration-time curve from time 0 to 24 hours was 4.09 (3.15) ng ∙ h/mL. Four subjects experienced a total of 5 treatment-emergent adverse events that resolved. Mild to moderate erythema, flaking, or scaling in the treatment area peaked around day 8 before resolving or returning to baseline by day 29. In conclusion, under maximal use conditions, tirbanibulin ointment 1% for 5 days in the treatment of AK on the face or scalp was well tolerated and resulted in low systemic exposure with subnanomolar plasma concentrations.",2022,∙ h/mL. Four subjects experienced a total of 5 treatment-emergent adverse events that resolved.,"['Subjects With Actinic Keratosis', 'Subjects were White (100%), of mean [range] age 66.4 [43-83] years, predominantly men (83.3%) with Fitzpatrick skin type', 'adults with actinic keratosis (AK', 'Eighteen subjects (face or scalp, n = 9 each) completed the study']","['Tirbanibulin Ointment', 'tirbanibulin ointment', 'Tirbanibulin']","['median time to maximum concentration', 'overall mean (standard deviation) maximum concentration (C max  ', 'adverse events and local skin reactions', 'PK sampling', 'plasma concentration-time curve']","[{'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0028912', 'cui_str': 'Ointment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.0414001,∙ h/mL. Four subjects experienced a total of 5 treatment-emergent adverse events that resolved.,"[{'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Yavel', 'Affiliation': 'TKL Research Inc., Fair Lawn, New Jersey, USA.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Overcash', 'Affiliation': 'Velocity Clinical Research, San Diego, California, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cutler', 'Affiliation': 'Athenex Inc., Buffalo, New York, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Athenex Inc., Buffalo, New York, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Zhi', 'Affiliation': 'Athenex Inc., Buffalo, New York, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.1041']
1288,34784247,"Skeletal muscle adaptations to exercise are not influenced by metformin treatment in humans: secondary analyses of 2 randomized, clinical trials.","Metformin and exercise both improve glycemic control, but in vitro studies have indicated that an interaction between metformin and exercise occurs in skeletal muscle, suggesting a blunting effect of metformin on exercise training adaptations. Two studies (a double-blind, parallel-group, randomized clinical trial conducted in 29 glucose-intolerant individuals and a double-blind, cross-over trial conducted in 15 healthy lean males) were included in this paper. In both studies, the effect of acute exercise ± metformin treatment on different skeletal muscle variables, previously suggested to be involved in a pharmaco-physiological interaction between metformin and exercise, was assessed. Furthermore, in the parallel-group trial, the effect of 12 weeks of exercise training was assessed. Skeletal muscle biopsies were obtained before and after acute exercise and 12 weeks of exercise training, and mitochondrial respiration, oxidative stress and AMPK activation was determined. Metformin did not significantly affect the effects of acute exercise or exercise training on mitochondrial respiration, oxidative stress or AMPK activation, indicating that the response to acute exercise and exercise training adaptations in skeletal muscle is not affected by metformin treatment. Further studies are needed to investigate whether an interaction between metformin and exercise is present in other tissues, e.g., the gut. Trial registration: ClinicalTrials.gov (NCT03316690 and NCT02951260).  Novelty:  Metformin does not affect exercise-induced alterations in mitochondrial respiratory capacity in human skeletal muscle. Metformin does not affect exercise-induced alterations in systemic levels of oxidative stress nor emission of reactive oxygen species from human skeletal muscle. Metformin does not affect exercise-induced AMPK activation in human skeletal muscle.",2022,"Metformin did not significantly affect the effects of acute exercise or exercise training on mitochondrial respiration, oxidative stress or AMPK activation, indicating that the response to acute exercise and exercise training adaptations in skeletal muscle is not affected by metformin treatment.","['29 glucose-intolerant individuals and a double-blind, cross-over trial conducted in 15 healthy lean males', 'humans', 'human skeletal muscle •']","['acute exercise ', 'exercise training', 'Metformin', 'metformin']","['Skeletal muscle biopsies', 'mitochondrial respiration, oxidative stress or AMPK activation', 'Novelty bullets •', 'mitochondrial respiration, oxidative stress and AMPK activation']","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]","[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C2315740', 'cui_str': 'Biopsy of skeletal muscle'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C2350345', 'cui_str': 'AMP-Activated Protein Kinase'}, {'cui': 'C0336699', 'cui_str': 'Bullet'}]",15.0,0.0527742,"Metformin did not significantly affect the effects of acute exercise or exercise training on mitochondrial respiration, oxidative stress or AMPK activation, indicating that the response to acute exercise and exercise training adaptations in skeletal muscle is not affected by metformin treatment.","[{'ForeName': 'Nanna S', 'Initials': 'NS', 'LastName': 'Pilmark', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Oberholzer', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Halling', 'Affiliation': 'Department of Biology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jonas M', 'Initials': 'JM', 'LastName': 'Kristensen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Christina P', 'Initials': 'CP', 'LastName': 'Bønding', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Elkjær', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lyngbæk', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Grit', 'Initials': 'G', 'LastName': 'Elster', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Siebenmann', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Niels F R', 'Initials': 'NFR', 'LastName': 'Holm', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Jesper B', 'Initials': 'JB', 'LastName': 'Birk', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Emil L', 'Initials': 'EL', 'LastName': 'Larsen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg and Frederiksberg Hospital, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Anne-Kristine M', 'Initials': 'AM', 'LastName': 'Lundby', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Wojtaszewski', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Pilegaard', 'Affiliation': 'Department of Biology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik E', 'Initials': 'HE', 'LastName': 'Poulsen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg and Frederiksberg Hospital, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Bente K', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Katrine B', 'Initials': 'KB', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University Hospital of Copenhagen, Denmark.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2021-0194']
1289,34785427,Associations of adipokine levels with the prevalence and extent of valvular and thoracic aortic calcification: The Multi-Ethnic Study of Atherosclerosis (MESA).,"BACKGROUND AND AIMS


Extra-coronary calcification (ECC) is a marker of atherosclerosis and independently associated with cardiovascular disease (CVD). Adipokines may mediate the effect of obesity on atherosclerosis. However, the relationship of adipokines with ECC is not well-established. We examined the associations of leptin, resistin and adiponectin with ECC in a diverse community-based cohort.
METHODS


We performed a cross-sectional analysis of 1897 adults without clinical CVD in the MESA cohort. Serum adipokine levels and non-contrast cardiac CT scans were obtained at Exam 2 or 3 (randomly assigned). ECC was quantified by Agatston score and included calcification of the mitral annulus (MAC), aortic valve (AVC), ascending thoracic aorta (ATAC) and descending thoracic aorta (DTAC). We used multivariable regression to evaluate the associations between leptin, resistin and adiponectin [per 1 SD ln(adipokine] with ECC prevalence (score >0) and extent [ln(score+1)].
RESULTS


The mean age of participants was 65 ± 10 years; 49% women. After adjusting for demographic factors, adiponectin was inversely associated with AVC prevalence and extent; leptin positively associated with MAC prevalence and extent; and resistin positively associated with ATAC prevalence and extent and DTAC extent. After adjustment for BMI and other CVD risk factors, adiponectin remained inversely associated with AVC prevalence, and resistin remained associated with greater ATAC prevalence and extent. Leptin was not associated with measures of ECC after full adjustment. No adipokine was associated with MAC after full adjustment.
CONCLUSIONS


We identified significant associations between select adipokines and specific markers of ECC. Adipokines may play a role in the development of systemic atherosclerosis.",2021,"After adjusting for demographic factors, adiponectin was inversely associated with AVC prevalence and extent; leptin positively associated with MAC prevalence and extent; and resistin positively associated with ATAC prevalence and extent and DTAC extent.","['valvular and thoracic aortic calcification', '1897 adults without clinical CVD in the MESA cohort', 'The mean age of participants was 65\xa0±\xa010 years; 49% women']",[],"['Agatston score and included calcification of the mitral annulus (MAC), aortic valve (AVC), ascending thoracic aorta (ATAC) and descending thoracic aorta (DTAC', 'leptin, resistin and adiponectin [per 1 SD ln(adipokine] with ECC prevalence (score >0) and extent [ln(score+1', 'Leptin', 'Serum adipokine levels and non-contrast cardiac CT scans']","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0225947', 'cui_str': 'Structure of anulus fibrosus of mitral orifice'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C1522460', 'cui_str': 'Thoracic aorta structure'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0412618', 'cui_str': 'Cardiac CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]",1897.0,0.142619,"After adjusting for demographic factors, adiponectin was inversely associated with AVC prevalence and extent; leptin positively associated with MAC prevalence and extent; and resistin positively associated with ATAC prevalence and extent and DTAC extent.","[{'ForeName': 'Ty', 'Initials': 'T', 'LastName': 'Sweeney', 'Affiliation': 'Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Oluseye', 'Initials': 'O', 'LastName': 'Ogunmoroti', 'Affiliation': 'Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Chiadi E', 'Initials': 'CE', 'LastName': 'Ndumele', 'Affiliation': 'Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bhavya', 'Initials': 'B', 'LastName': 'Varma', 'Affiliation': 'Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Allison', 'Affiliation': 'Department of Family Medicine, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': 'Lundquist Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Oluwaseun E', 'Initials': 'OE', 'LastName': 'Fashanu', 'Affiliation': 'Department of Medicine, St Agnes Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Apurva', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Icahn School of Medicine, Mount Sinai Hospital, New York City, NY, USA.'}, {'ForeName': 'Alain G', 'Initials': 'AG', 'LastName': 'Bertoni', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston Salem, NC, USA.'}, {'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Michos', 'Affiliation': 'Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: edonnell@jhmi.edu.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2021.11.002']
1290,34787096,Effect of Early Enteral Nutrition on Serum Inflammatory Factors and Intestinal Mucosal Permeability in Patients with Severe Acute Pancreatitis.,"BACKGROUND


To analyze the effect of early enteral nutrition on serum inflammatory factors and intestinal mucosal permeability in patients with severe acute pancreatitis.
METHODS


A total of 55 patients with severe acute pancreatitis were divided into 2 groups: the control group (n = 27), who received routine treatment and the observation group (n = 28), who received early enteral nutrition. The expression of serum inflammatory factors and the permeability of the intestinal mucosa were compared between the 2 groups before and after treatment, and rates of infection and mortality within 30 days were statistically analyzed.
RESULTS


The recovery duration of serum and urine amylase and the length of hospital stay in the observation group were shorter than those in the control group. The white blood cell counts, levels of procalcitonin, and the expression of interleukin-6 (IL-6) in the observation group were lower than those in the control group 7 days after the treatment was commenced, and the differences were statistically significant (P < .05). The concentration of diamine oxidase in the serum and the urinary lactulose to mannitol (L/M) ratio in the observation group were lower than those in the control group 7 days after treatment was commenced. The infection rate in the observation group (21.43%) was lower than that in the control group (51.85%) (P < .05). There was no difference in the 30-day mortality between the 2 groups (P > .05).
CONCLUSION


Early enteral nutrition may reduce the expression of serum inflammatory factors, decrease the permeability of the intestinal mucosa, and improve the prognosis of patients with severe acute pancreatitis.",2021,"The expression of serum inflammatory factors and the permeability of the intestinal mucosa were compared between the 2 groups before and after treatment, and rates of infection and mortality within 30 days were statistically analyzed.
","['55 patients with severe acute pancreatitis', 'Patients with Severe Acute Pancreatitis', 'patients with severe acute pancreatitis']","['Early Enteral Nutrition', 'routine treatment and the observation group', 'early enteral nutrition']","['expression of serum inflammatory factors and the permeability of the intestinal mucosa', 'concentration of diamine oxidase', 'rates of infection and mortality', '30-day mortality', 'urinary lactulose to mannitol (L/M) ratio', 'infection rate', 'recovery duration of serum and urine amylase and the length of hospital stay', 'white blood cell counts, levels of procalcitonin, and the expression of interleukin-6 (IL-6', 'Serum Inflammatory Factors and Intestinal Mucosal Permeability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021839', 'cui_str': 'Intestinal mucous membrane structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0019587', 'cui_str': 'Amine oxidase (copper-containing)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0201886', 'cui_str': 'Amylase measurement, urine'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0232645', 'cui_str': 'Intestinal mucosal permeability'}]",55.0,0.016282,"The expression of serum inflammatory factors and the permeability of the intestinal mucosa were compared between the 2 groups before and after treatment, and rates of infection and mortality within 30 days were statistically analyzed.
","[{'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, The Second Affiliated Hospital of Air Force Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jin-Ni', 'Initials': 'JN', 'LastName': 'Jian', 'Affiliation': ""Department of Critical Care Medicine, Gao Ling Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Rui-Lin', 'Initials': 'RL', 'LastName': 'Chen', 'Affiliation': ""Department of Pulmonary and Critical Care Medicine, Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, China.""}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2021.201033']
1291,34788569,Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-Disabling Stroke or Transient Ischemic Attack (PREVENT Trial): A Randomized Controlled Trial.,"BACKGROUND


Non-disabling stroke (NDS) and transient ischemic attack (TIA) herald the possibility of future, more debilitating vascular events. Evidence is conflicting about potency of exercise and education in reducing risk factors for second stroke.
METHODS


Three-site, single-blinded, randomized controlled trial with 184 participants <3 months of NDS or TIA (mean age, 65 years; 66% male) randomized to usual care (UC) or UC + 12-week program of exercise and education (PREVENT). Primary (resting systolic blood pressure) and secondary outcomes (diastolic blood pressure [DBPrest], high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C], total cholesterol [TC], TC/HDL, triglycerides, fasting glucose, and body mass index) were assessed at baseline, post-intervention, and 6- and 12-month follow-up. Peak oxygen consumption (VO 2 peak) was measured at baseline, post-intervention, 12-month assessments.
RESULTS


Significant between-group differences at post-intervention favored PREVENT group over UC: DBPrest (mean difference [MD]: -3.2 mmHg, 95% confidence interval [CI]: -6.3, -.2,  P  = .04) and LDL-C (MD: -.31 mmol/L, 95% CI: -.42, -.20,  P  = .02). Trends of improvement in PREVENT group were noted in several variables between baseline and 6-month follow-up but not sustained at 12-month follow-up. Of note, VO 2  peak did not change over time in either group.
CONCLUSION


Impact of PREVENT on vascular risk factor reduction was more modest than anticipated, possibly because several outcome variables approximated normative values at baseline and training intensity may have been sub-optimal. Further investigation is warranted to determine when exercise and education programs are viable adjuncts to pharmaceutical management for reduction of risk factors for second stroke. Clinical Trial Registration-URL:  http://www.clinicaltrials.gov. Unique identifier: #NCT00885456.",2022,Trends of improvement in PREVENT group were noted in several variables between baseline and 6-month follow-up but not sustained at 12-month follow-up.,"['184 participants <3\xa0months of NDS or TIA (mean age, 65\xa0years; 66% male) randomized to', 'After Non-Disabling Stroke or Transient Ischemic Attack (PREVENT Trial']","['Rehabilitative Exercise and Education to Avert Vascular Events', 'usual care (UC) or UC + 12-week program of exercise and education (PREVENT']","['Primary (resting systolic blood pressure) and secondary outcomes (diastolic blood pressure [DBPrest], high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C], total cholesterol [TC], TC/HDL, triglycerides, fasting glucose, and body mass index', 'Peak oxygen consumption (VO 2 peak', 'vascular risk factor reduction']","[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",184.0,0.218568,Trends of improvement in PREVENT group were noted in several variables between baseline and 6-month follow-up but not sustained at 12-month follow-up.,"[{'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'MacKay-Lyons', 'Affiliation': 'School of Physiotherapy, 3688Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Gubitz', 'Affiliation': 'Neurology, 3688Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Phillips', 'Affiliation': 'Neurology, 3688Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Giacomantonio', 'Affiliation': '12361QEII Health Sciences Centre, Halifax, NS, Canada.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Firth', 'Affiliation': 'Cardiac Rehabilitation, QEII Community Cardiovascular Hearts-in-Motion, Halifax, NS, Canada.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Thompson', 'Affiliation': 'Nova Scotia Health, Research Methods Unit, Halifax, NS, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Theriault', 'Affiliation': 'Nova Scotia Health, Research Methods Unit, Halifax, NS, Canada.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Wightman', 'Affiliation': 'Cardiology Associates, Valley Regional Hospital, Kentville, NS, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Slipp', 'Affiliation': 'Cardiac Rehabilitation, Valley Regional Hospital, Kentville, NS, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Marsters', 'Affiliation': 'Internal Medicine, Valley Regional Hospital, Kentville, NS, Canada.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Eskes', 'Affiliation': 'Physical Medicine, Nova Scotia Health Authority, Halifax, NS, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Peacock', 'Affiliation': 'Cardiac Specialty Clinic, Valley Regional Hospital, Kentville, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Blanchard', 'Affiliation': 'Medicine, Nova Scotia Health, Halifax, NS, Canada.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Dewolfe', 'Affiliation': 'Cardiac Specialty Clinic, Valley Regional Hospital, Kentville, Canada.'}]",Neurorehabilitation and neural repair,['10.1177/15459683211060345']
1292,34791009,"Genosets for APOE and CYP7A1-rs3808607 variants do not predict LDL cholesterol lowering upon intervention with plant sterols in a randomized, double-blind, placebo-controlled trial.","BACKGROUND


The consumption of 2 g/d plant sterols (PSs) reduces circulating LDL cholesterol by ≤10%. The degree of LDL cholesterol lowering was associated with specific apolipoprotein E [APOE, Reference SNP (rs)429358] and cholesterol 7α-hydroxylase (CYP7A1, rs3808607) genosets in previous post hoc analyses of randomized controlled trials. However, because post hoc analyses do not conform to the randomization model, there is a greater potential that the findings could be due to type I error, thus warranting validation through an a priori-designed intervention trial.
OBJECTIVES


The GenePredict Plant Sterol study (GPS) was designed to validate associations of LDL cholesterol lowering with specific APOE and CYP7A1 genosets through a priori recruitment of individuals carrying prespecified genosets.
METHODS


A 2-center, double-blind, placebo-controlled, randomized 2-period crossover dietary intervention with 2 g/d PS for 28 d with a minimum 28-d washout was undertaken from July 2017 to December 2019. A priori recruitment of individuals with slightly elevated LDL cholesterol was based on genosets of APOE isoforms and CYP7A1 rs3808607. Randomization was performed with stratification by sex and genoset.
RESULTS


The recruitment target of 64 participants with prespecified genosets could not be reached, despite the screening of 477 individuals; 42 participants completed the intervention trial. Reductions in LDL cholesterol were similar across all 3 genosets (-0.298 ± 0.164, -0.357 ± 0.115, -0.293 ± 0.109 mmol/L; P = 0.0002 overall; P = 0.9126 for treatment × genoset), providing evidence that the shortfall in recruitment might not have stopped the trial from meeting the objective.
CONCLUSIONS


APOE and CYP7A1 genotypes did not influence the efficacy of LDL cholesterol reductions upon dietary intervention with PSs. Findings of previous post hoc analyses could not be validated in a trial using a priori genotype-based recruitment. Obtaining adequate numbers of participants is challenging in trials using genoset-based recruitment, even for common variants.",2022,"The degree of LDL-C lowering was associated with specific apolipoprotein E (APOE, rs429358) and cholesterol 7α-hydroxylase","['64 participants with pre-specified genosets could not be reached, despite the screening of 477 individuals; 42 participants completed the intervention trial']",['placebo'],"['specific apolipoprotein E (APOE, rs429358) and cholesterol 7α-hydroxylase', 'LDL-C', 'circulating low-density lipoprotein cholesterol (LDL-C']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003595', 'cui_str': 'Apolipoprotein E'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0020364', 'cui_str': 'Mixed function oxygenase'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",64.0,0.453586,"The degree of LDL-C lowering was associated with specific apolipoprotein E (APOE, rs429358) and cholesterol 7α-hydroxylase","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Granger', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Faculty of Agricultural and Food Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Eck', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Faculty of Agricultural and Food Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Itzel', 'Initials': 'I', 'LastName': 'Vazquez-Vidal', 'Affiliation': 'Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shamloo', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Faculty of Agricultural and Food Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'House', 'Affiliation': 'Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Mackay', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Faculty of Agricultural and Food Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab378']
1293,34791007,"The effect of camelina oil on vascular function in essential hypertensive patients with metabolic syndrome: a randomized, placebo-controlled, double-blind study.","BACKGROUND


The effects of a dietary supplementation with the vegetable ω-3 α-linolenic acid (ALA) on cardiovascular homeostasis are unclear. In this context, it would be interesting to assess the effects of camelina oil.
OBJECTIVE


This study aimed to assess the cardiovascular and metabolic effects of camelina oil in hypertensive patients with metabolic syndrome.
METHODS


In a double-blind, placebo-controlled randomized study, treated essential hypertensive patients with metabolic syndrome received, during 6 mo, either cyclodextrin-complexed camelina oil containing ≈ 1.5 g ALA/d (n = 40) or an isocaloric placebo (n = 41), consisting of the same quantity of cyclodextrins and wheat starch. Anthropometric data, plasma lipids, glycemia, insulinemia, creatininemia, TBARs, high-sensitivity C-reactive protein, and n-3, n-6, and n-9 fatty acids in erythrocyte membranes were measured. Peripheral and central blood pressures, arterial stiffness, carotid intima-media thickness, and brachial artery endothelium-dependent flow-mediated dilatation (FMD) and endothelium-independent dilatation were assessed.
RESULTS


Compared with placebo, camelina oil increased ALA (mean ± SD: 0 ± 0.04 compared with 0.08 ± 0.06%, P <0.001), its elongation product EPA (0 ± 0.5 compared with 0.16 ± 0.65%, P <0.05), and the n-9 gondoic acid (GA; 0 ± 0.04 compared with 0.08 ± 0.04%, P <0.001). No between-group difference was observed for cardiovascular parameters. However, changes in FMD were associated with the magnitude of changes in EPA (r = 0.26, P = 0.03). Compared with placebo, camelina oil increased fasting glycemia (-0.2 ± 0.6 compared with 0.3 ± 0.5 mmol/L, P <0.001) and HOMA-IR index (-0.8 ± 2.5 compared with 0.5 ± 0.9, P <0.01), without affecting plasma lipids, or inflammatory and oxidative stress markers. Changes in HOMA-IR index were correlated with the magnitude of changes in GA (r = 0.32, P <0.01). Nutritional intake remained similar between groups.
CONCLUSION


ALA supplementation with camelina oil did not improve vascular function but adversely affected glucose metabolism in hypertensive patients with metabolic syndrome. Whether this adverse effect on insulin sensitivity is related to GA enrichment, remains to be elucidated.",2022,"ALA supplementation with camelina oil did not improve vascular function but adversely affected glucose metabolism in hypertensive patients with metabolic syndrome Whether this adverse effect on insulin sensitivity is related to gondoic acid enrichment, remains to be elucidated.","['treated essential hypertensive patients with metabolic syndrome', 'essential hypertensive patients with metabolic syndrome', 'hypertensive patients with metabolic syndrome']","['placebo, camelina oil', 'camelina oil', 'cyclodextrin-complexed camelina oil containing\xa0≈\xa01.5\xa0g ALA/day (n\xa0=\xa040), or an isocaloric placebo', 'dietary supplementation with the vegetable omega-3 α-linolenic acid (ALA', 'placebo', 'ALA supplementation with camelina oil']","['n-9 gondoic acid', 'Anthropometric data, plasma lipids, glycemia, insulinemia, creatininemia, thiobarbituric acid reactive substances, high-sensitivity C-reactive protein, and n-3, n-6 and n-9 fatty acids in erythrocyte membranes', 'elongation product eicosapentaenoic acid', 'ALA (mean\xa0±\xa0SD', 'plasma lipids, or inflammatory and oxidative stress markers', 'HOMA-IR index', 'vascular function', 'fasting glycemia', 'homeostatic model assessment for insulin resistance', 'Peripheral and central blood pressures, arterial stiffness, carotid intima-media thickness and brachial artery endothelium-dependent flow-mediated dilatation and endothelium-independent dilatation', 'Nutritional intake', 'cardiovascular parameters', 'changes in flow-mediated dilatation']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0010558', 'cui_str': 'Cyclodextrins'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C2348390', 'cui_str': 'eicosenoic acid'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0014780', 'cui_str': 'Erythrocyte Cytoskeleton'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.231159,"ALA supplementation with camelina oil did not improve vascular function but adversely affected glucose metabolism in hypertensive patients with metabolic syndrome Whether this adverse effect on insulin sensitivity is related to gondoic acid enrichment, remains to be elucidated.","[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bellien', 'Affiliation': 'Department of Pharmacology, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Bozec', 'Affiliation': 'Université de Paris, Service de Pharmacologie, INSERM U970, équipe 7, Paris, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Bounoure', 'Affiliation': 'Normandie Université, UNIROUEN, INSERM U1239, Pharmacie Galénique, Rouen France.'}, {'ForeName': 'Hakim', 'Initials': 'H', 'LastName': 'Khettab', 'Affiliation': 'Université de Paris, Service de Pharmacologie, INSERM U970, équipe 7, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Malloizel-Delaunay', 'Affiliation': 'Department of Vascular Medicine, University Hospital of Toulouse, Toulouse, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Skiba', 'Affiliation': 'Service de Pharmacologie, AP-HP, HEGP, Paris, France.'}, {'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Iacob', 'Affiliation': 'Department of Pharmacology, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Donnadieu', 'Affiliation': 'Department of Pharmacy, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Coquard', 'Affiliation': 'Department of Pharmacy, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Morio', 'Affiliation': ""Unité de Nutrition Humaine (UNH), Institut national de recherche pour l'agriculture, l'alimentation et l'environnement (INRAE), Université Clermont Auvergne, CRNH Auvergne, Clermont-Ferrand, France.""}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Laillet', 'Affiliation': ""Unité de Nutrition Humaine (UNH), Institut national de recherche pour l'agriculture, l'alimentation et l'environnement (INRAE), Université Clermont Auvergne, CRNH Auvergne, Clermont-Ferrand, France.""}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Rigaudière', 'Affiliation': ""Unité de Nutrition Humaine (UNH), Institut national de recherche pour l'agriculture, l'alimentation et l'environnement (INRAE), Université Clermont Auvergne, CRNH Auvergne, Clermont-Ferrand, France.""}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Chardigny', 'Affiliation': ""Unité de Nutrition Humaine (UNH), Institut national de recherche pour l'agriculture, l'alimentation et l'environnement (INRAE), Université Clermont Auvergne, CRNH Auvergne, Clermont-Ferrand, France.""}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Monteil', 'Affiliation': 'Normandie Université, UNIROUEN, UNICAEN, ABTE, Rouen, France.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Vendeville', 'Affiliation': 'Normandie Université, UNIROUEN, UNICAEN, ABTE, Rouen, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Mercier', 'Affiliation': 'Department of General Practice, University of Paris 13, SMBH, Bobigny, France.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Cailleux', 'Affiliation': ""Centre d'Investigation Clinique (CIC)-INSERM 1404, Rouen University Hospital, Rouen, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Blanchard', 'Affiliation': ""Centre d'Investigation Clinique INSERM CIC-1418, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, Paris, France.""}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Amar', 'Affiliation': 'Department of Arterial Hypertension, Toulouse University III, Toulouse, France.'}, {'ForeName': 'Léopold K', 'Initials': 'LK', 'LastName': 'Fezeu', 'Affiliation': 'Sorbonne Paris Nord University, INSERM U1153, INRAE U1125, CNAM, Nutritional Epidemiology Research Team (EREN), Epidemiology and Statistics Research Center-University of Paris (CRESS), Bobigny, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pannier', 'Affiliation': 'Department of Nephrology, Centre Hospitalier FH Manhès, Fleury-Mérogis, France.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bura-Rivière', 'Affiliation': 'Department of Vascular Medicine, University Hospital of Toulouse, Toulouse, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boutouyrie', 'Affiliation': 'Université de Paris, Service de Pharmacologie, INSERM U970, équipe 7, Paris, France.'}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Joannidès', 'Affiliation': 'Department of Pharmacology, Rouen University Hospital, Rouen, France.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab374']
1294,34792094,"The effect of zinc-biofortified rice on zinc status of Bangladeshi preschool children: a randomized, double-masked, household-based, controlled trial.","BACKGROUND


Zinc biofortification of rice could sustainably improve zinc status in countries where zinc deficiency is common and rice is a staple, but its efficacy has not been tested. Fatty acid desaturases (FADS) are putative new zinc status biomarkers.
OBJECTIVES


Our objective was to test the efficacy of zinc-biofortified rice (BFR) in preschool-aged children with zinc deficiency. Our hypothesis was that consumption of BFR would increase plasma zinc concentration (PZC).
METHODS


We conducted a 9-mo, double-masked intervention trial in 12-36-mo-old rural Bangladeshi children, most of whom were zinc-deficient (PZC <70 µg/dL) and stunted (n = 520). The children were randomly assigned to receive either control rice (CR) or BFR provided in cooked portions to their households daily, with compliance monitoring. The primary outcome was PZC. Secondary outcomes were zinc deficiency, linear growth, infection-related morbidity, FADS activity indices, intestinal fatty acid binding protein (I-FABP) and fecal calprotectin. We applied sparse serial sampling for midpoint measures and analyzed data by intention-to-treat using mixed-effects models.
RESULTS


At baseline, median (IQR) PZC was 60.4 (56.3-64.3) µg/dL, 78.1% of children were zinc deficient, and 59.7% were stunted. Mean ± SD daily zinc intakes from the CR and BFR during the trial were 1.20 ± 0.34 and 2.22 ± 0.47 mg/d, respectively (P < 0.001). There were no significant time-by-treatment effects on PZC, zinc deficiency prevalence, FADS activity, I-FABP, or fecal calprotectin (all P > 0.05). There was a time-treatment interaction for height-for-age z-scores (P < 0.001) favoring the BFR group. The morbidity longitudinal prevalence ratio was 1.08 (95% CI: 1.05, 1.12) comparing the BFR and CR groups, due to more upper respiratory tract illness in the BFR group.
CONCLUSIONS


Consumption of BFR for 9 mo providing ∼1 mg of additional zinc daily to Bangladeshi children did not significantly affect PZC, prevalence of zinc deficiency, or FADS activity.The trial was registered at clinicaltrials.gov as NCT03079583.",2022,There was a time-treatment interaction for height-for-age z scores (P < 0.001) favoring the BFR group.,"['Bangladeshi pre-school children', 'preschool-aged children with zinc-deficiency', '12-36 month-old rural Bangladeshi children, most of whem were who were zinc-deficient (PZC < 70\xa0µg/dL) and stunted (n\xa0=\xa0520']","['Fatty acid desaturases (FADS', 'control rice (CR) or zinc-biofortified rice (BFR) provided in cooked portions to their households daily, with compliance monitoring', 'zinc-biofortified rice']","['median (IQR) PZC', 'zinc deficiency, linear growth, infection-related morbidity, FADS activity indices, intestinal fatty acid binding protein (I-FABP) and fecal calprotectin', 'Mean\xa0±', 'plasma zinc concentration (PZC', 'PZC, zinc deficiency prevalence, FADS activity, I-FABP or fecal calprotectin', 'time-treatment interaction for height-for-age z scores', 'zinc status', 'morbidity longitudinal prevalence ratio (LPR', 'SD daily zinc intakes', 'PZC, prevalence of zinc deficiency or FADS activity', 'upper respiratory tract illness']","[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0235950', 'cui_str': 'Zinc deficiency'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C4517803', 'cui_str': '520'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0235950', 'cui_str': 'Zinc deficiency'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0564449', 'cui_str': 'Zinc intake'}, {'cui': 'C0458578', 'cui_str': 'Upper respiratory tract structure'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]",,0.569995,There was a time-treatment interaction for height-for-age z scores (P < 0.001) favoring the BFR group.,"[{'ForeName': 'Roelinda', 'Initials': 'R', 'LastName': 'Jongstra', 'Affiliation': 'Laboratory for Human Nutrition, Institute of Food, Nutrition and Health, ETH Zürich, Zurich, Switzerland.'}, {'ForeName': 'Md Mokbul', 'Initials': 'MM', 'LastName': 'Hossain', 'Affiliation': 'James P Grant School of Public Health, BRAC University, Dhaka, Bangladesh.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Galetti', 'Affiliation': 'Laboratory for Human Nutrition, Institute of Food, Nutrition and Health, ETH Zürich, Zurich, Switzerland.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Hall', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Roberta R', 'Initials': 'RR', 'LastName': 'Holt', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Colin I', 'Initials': 'CI', 'LastName': 'Cercamondi', 'Affiliation': 'Laboratory for Human Nutrition, Institute of Food, Nutrition and Health, ETH Zürich, Zurich, Switzerland.'}, {'ForeName': 'Sabina F', 'Initials': 'SF', 'LastName': 'Rashid', 'Affiliation': 'James P Grant School of Public Health, BRAC University, Dhaka, Bangladesh.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Zimmermann', 'Affiliation': 'Laboratory for Human Nutrition, Institute of Food, Nutrition and Health, ETH Zürich, Zurich, Switzerland.'}, {'ForeName': 'Malay K', 'Initials': 'MK', 'LastName': 'Mridha', 'Affiliation': 'James P Grant School of Public Health, BRAC University, Dhaka, Bangladesh.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Wegmueller', 'Affiliation': 'Laboratory for Human Nutrition, Institute of Food, Nutrition and Health, ETH Zürich, Zurich, Switzerland.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab379']
1295,34805718,Lessons Learned From Implementing a Novel Bayesian Adaptive Dose-Finding Design in Advanced Pancreatic Cancer.,"PURPOSE


Novel Bayesian adaptive designs provide an effective way to improve clinical trial efficiency. These designs are superior to conventional methods, but implementing them can be challenging. The aim of this article was to describe what we learned while applying a novel Bayesian phase I-II design in a recent trial.
METHODS


The primary goal of the trial was to optimize radiation therapy (RT) dose among three levels (low, standard, and high), given either with placebo (P) or an investigational agent (A), for treating locally advanced, radiation-naive pancreatic cancer, deemed appropriate for RT rather than surgery. Up to 48 patients were randomly assigned fairly between RT plus P and RT plus A, with RT dose-finding done within each arm using the late-onset efficacy-toxicity design on the basis of two coprimary end points, tumor response and dose-limiting toxicity, both evaluated at up to 90 days. The random assignment was blinded, but within each arm, unblinded RT doses were chosen adaptively using software developed within the institution.
RESULTS


Implementing the design involved double-blind balance-restricted random assignment, real-time assessment of patient outcomes to evaluate the efficacy-toxicity trade-off for each RT dose in each arm to optimize each patient's RT dose adaptively, and transition from a single-center trial to a multicenter trial. We present lessons learned and illustrative documentation.
CONCLUSION


Implementing novel Bayesian adaptive trial designs requires close collaborations between physicians, pharmacists, statisticians, data managers, and sponsors. The process is difficult but manageable and essential for efficient trial conduct. Close collaboration during trial conduct is a key component of any trial that includes real-time adaptive decision rules.",2021,"Up to 48 patients were randomly assigned fairly between RT plus P and RT plus A, with RT dose-finding done within each arm using the late-onset efficacy-toxicity design on the basis of two coprimary end points, tumor response and dose-limiting toxicity, both evaluated at up to 90 days.","['48 patients', 'Advanced Pancreatic Cancer']","['placebo (P) or an investigational agent (A', 'radiation therapy (RT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],48.0,0.183068,"Up to 48 patients were randomly assigned fairly between RT plus P and RT plus A, with RT dose-finding done within each arm using the late-onset efficacy-toxicity design on the basis of two coprimary end points, tumor response and dose-limiting toxicity, both evaluated at up to 90 days.","[{'ForeName': 'Rebecca S S', 'Initials': 'RSS', 'LastName': 'Tidwell', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Thall', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX.'}]",JCO precision oncology,['10.1200/PO.21.00212']
1296,34807763,Randomized Controlled Study of Tenofovir versus Lamivudine Followed by Tenofovir in Severe Exacerbation of Hepatitis B.,"Spontaneous severe acute exacerbation (SAE) is not uncommon in the natural history of chronic hepatitis B (CHB). Lamivudine (LAM) has the advantages of low price, quick onset, good efficacy, and no drug resistance within 24 weeks. This study aimed to compare the short-term efficacy of tenofovir disoproxil fumarate (TDF) and LAM for 24 weeks followed by TDF in the treatment of CHB with severe acute exacerbation. Consecutive patients of CHB with SAE were randomized to receive either TDF (19 patients) or LAM for 24 weeks, followed by TDF (18 patients). The primary endpoint was overall mortality or receipt of liver transplantation by week 24. This study was approved by the Institutional Review Board (IRB) of the Kaohsiung Veterans General Hospital (VGHKS12-CT5-10). The baseline characteristics were comparable between the two groups. By week 24, seven (37%) and five (28%) patients in the TDF and LAM-TDF groups died or received liver transplantation ( P  = 0.487). Multivariate analysis showed that albumin level, prothrombin time (PT), and hepatic encephalopathy were independent factors associated with mortality or liver transplantation by week 24. Early reductions in HBV DNA of more than or equal to 2 log at 1 and 2 weeks were similar between the two groups. The biochemical and virological responses at 12, 24, and 48 weeks were also similar between the two groups. TDF and LAM for 24 weeks followed by TDF achieved a similar clinical outcome in CHB patients with SAE. (This study has been registered at ClinicalTrials.gov under identifier NCT01848743).",2022,Early reductions in HBV DNA of more than or equal to 2 log at 1 and 2 weeks were similar between the two groups.,"['CHB with severe acute exacerbation', 'CHB patients with SAE', 'Consecutive patients of CHB with SAE', 'Spontaneous severe acute exacerbation (SAE', 'Kaohsiung Veterans General Hospital (VGHKS12-CT5-10', 'severe exacerbation of hepatitis B']","['tenofovir disoproxil fumarate (TDF) and LAM', 'LAM', 'Tenofovir versus lamivudine', 'Lamivudine (LAM', 'TDF and LAM', 'TDF', 'tenofovir']","['albumin level, prothrombin time (PT), and hepatic encephalopathy', 'HBV DNA', 'overall mortality or receipt of liver transplantation', 'biochemical and virological responses', 'mortality or liver transplantation']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}]","[{'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}]",,0.065271,Early reductions in HBV DNA of more than or equal to 2 log at 1 and 2 weeks were similar between the two groups.,"[{'ForeName': 'Chia-Ming', 'Initials': 'CM', 'LastName': 'Lu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospitalgrid.415011.0, Kaohsiung, Taiwan.'}, {'ForeName': 'Jin-Shiung', 'Initials': 'JS', 'LastName': 'Cheng', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospitalgrid.415011.0, Kaohsiung, Taiwan.'}, {'ForeName': 'Wei-Chih', 'Initials': 'WC', 'LastName': 'Sun', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospitalgrid.415011.0, Kaohsiung, Taiwan.'}, {'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospitalgrid.415011.0, Kaohsiung, Taiwan.'}, {'ForeName': 'Feng-Woei', 'Initials': 'FW', 'LastName': 'Tsay', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospitalgrid.415011.0, Kaohsiung, Taiwan.'}, {'ForeName': 'Huay-Min', 'Initials': 'HM', 'LastName': 'Wang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospitalgrid.415011.0, Kaohsiung, Taiwan.'}, {'ForeName': 'Tzung-Jiun', 'Initials': 'TJ', 'LastName': 'Tsai', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospitalgrid.415011.0, Kaohsiung, Taiwan.'}, {'ForeName': 'Sung-Shuo', 'Initials': 'SS', 'LastName': 'Kao', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospitalgrid.415011.0, Kaohsiung, Taiwan.'}, {'ForeName': 'Yun-Da', 'Initials': 'YD', 'LastName': 'Li', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospitalgrid.415011.0, Kaohsiung, Taiwan.'}, {'ForeName': 'Yuan-Rong', 'Initials': 'YR', 'LastName': 'Li', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospitalgrid.415011.0, Kaohsiung, Taiwan.'}, {'ForeName': 'Huey-Shyan', 'Initials': 'HS', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, Fooyin University, Kaohsiung, Taiwan.'}, {'ForeName': 'Chun-Hao', 'Initials': 'CH', 'LastName': 'Yin', 'Affiliation': 'Department of Medical Education and Research, Kaohsiung Veterans General Hospitalgrid.415011.0, Kaohsiung, Taiwan.'}, {'ForeName': 'Wei-Lun', 'Initials': 'WL', 'LastName': 'Tsai', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospitalgrid.415011.0, Kaohsiung, Taiwan.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01664-21']
1297,34809573,The use of perineural dexamethasone and transverse abdominal plane block for postoperative analgesia in cesarean section operations under spinal anesthesia: an observational study.,"BACKGROUND


During transverses abdominal plane block (TAP) procedure to provide analgesia in cesarean section (CS) operation, the use of perineural dexamethasone as an additive agent may improve pain relief and may cause a prolonged block duration. This study aims to investigate whether perineural dexamethasone, when added to bupivacaine local anesthetic agent during a TAP block, may provide adequate pain relief without adverse events.
METHODS


This is a prospective cohort study of fifty-eight patients undergoing elective CS with spinal anesthesia. We hypothesized to perform bilateral TAP block using perineural dexamethasone as an additive agent. The patients were randomly divided into two groups using a systematic random sampling method. While one group of patients received perineural dexamethasone of 8 mg additive agent together with bupivacaine 0.25% 40 ml (Group TAPD), the other group received only bupivacaine 0.25% 40 ml in TAP block (Group TAPA). The primary outcomes are the period for the first request of postoperative pain relief medication and the numerical rating scale (NRS) pain intensity scores at 2, 6, 12, and 24 h after surgery. The secondary outcomes are comparing the 24-h tramadol and diclofenac analgesic requirements and the incidences of side effects on postoperative day one. A p-value of < 0.05 is statistically significant.
RESULTS


The time to first analgesic request was 8.5 h (8.39-9.79) in the TAPD group versus 5.3 h (5.23-5.59) in the TAPA group, respectively. (p < 0.001) The median NRS scores were significantly reduced in the TAPD group compared to the TAPA group at 6, 12, and 24 h after surgery (p-values < 0.001). The total analgesics consumption over 24 h postoperatively was lower in Group TAPD compared to Group TAPA (p < 0.05).
CONCLUSION


An additive agent of perineural dexamethasone at a dose of 8 mg during bilateral TAP block for elective CS operation under spinal anesthesia provided better pain relief on postoperative day 1.",2021,"The total analgesics consumption over 24 h postoperatively was lower in Group TAPD compared to Group TAPA (p < 0.05).
","['fifty-eight patients undergoing elective CS with spinal anesthesia', 'cesarean section operations under spinal anesthesia']","['TAPD', 'perineural dexamethasone and transverse abdominal plane block', 'TAPA', 'perineural dexamethasone', 'bupivacaine 0.25% 40\u2009ml in TAP block (Group TAPA', 'bupivacaine', 'dexamethasone', 'bupivacaine 0.25% 40\u2009ml (Group TAPD']","['total analgesics consumption', 'pain relief', 'period for the first request of postoperative pain relief medication and the numerical rating scale (NRS) pain intensity scores', '24-h tramadol and diclofenac analgesic requirements and the incidences of side effects', 'median NRS scores', 'time to first analgesic request']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}]",58.0,0.0827488,"The total analgesics consumption over 24 h postoperatively was lower in Group TAPD compared to Group TAPA (p < 0.05).
","[{'ForeName': 'Abdisa', 'Initials': 'A', 'LastName': 'Aga', 'Affiliation': 'Department of Anesthesia, Harar College of Health Science, Harar, Ethiopia.'}, {'ForeName': 'Meron', 'Initials': 'M', 'LastName': 'Abrar', 'Affiliation': 'Department of Anesthesia, College of Health Science, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Zewetir', 'Initials': 'Z', 'LastName': 'Ashebir', 'Affiliation': 'Department of Anesthesia, College of Health Science, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Ashenafi', 'Initials': 'A', 'LastName': 'Seifu', 'Affiliation': 'Department of Anesthesia, College of Health Science, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Dereje', 'Initials': 'D', 'LastName': 'Zewdu', 'Affiliation': 'Department of Anesthesia, College of Health Science, Wolkite University, PO. Box: 1362, Wolkite, Ethiopia. derejezewdu1529@gmail.com.'}, {'ForeName': 'Diriba', 'Initials': 'D', 'LastName': 'Teshome', 'Affiliation': 'Department of Anesthesia, College of Health Science, Debre Tabor University, Debre Tabor, Ethiopia.'}]",BMC anesthesiology,['10.1186/s12871-021-01513-4']
1298,34773995,Adding a low-concentration sciatic nerve block to total knee arthroplasty in patients susceptible to the adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs): a randomized controlled trial.,"BACKGROUND


This study compared the effects of adductor canal blocks with those of a low concentration of popliteal-sciatic nerve block (SNB) and dexamethasone as an adjunctive technique for total knee arthroplasties (TKA) in patients susceptible to the adverse effects of NSAIDs.
METHODS


A prospective, double-blinded, randomized controlled trial was performed in 50 patients susceptible to the adverse effects of NSAIDs undergoing unilateral TKAs. All patients received spinal anesthesia, adductor canal blocks, and periarticular infiltration. The 25 patients in the intervention group received SNB (0.125% bupivacaine [20 ml] and dexamethasone [5 mg]).
RESULTS


The SNB group significantly had lower median resting pain scores at 6, 12, and 18 h: the control group, 1 (0-4.5), 3 (0-5), and 3 (2-5); the intervention group, 0 (0-0), 0 (0-3), and 1 (0-3); p-values, 0.012, 0.021, and 0.010, respectively. Movement-evoked pain scores at 6, 12, and 18 h were also lower: control group, 3 (0-5.5), 5 (2.5-6.5), and 7 (4-9); intervention group, 0 (0-1.5), 2 (0-4), and 3 (2-5); p-values, 0.019, 0.005, and 0.001, respectively. There were no differences in motor function. Moreover, the mean morphine consumption 24 h was also reduced in the SNB group: control group, 3.80 ± 2.48 mg; intervention group, 1.96 ± 2 mg; p-value, 0.005.
CONCLUSION


For patients susceptible to the adverse effects of NSAIDs, a low concentration of SNB and dexamethasone is an effective adjunctive technique for early postoperative pain control (especially on movement) following TKAs, without an increase in motor weakness.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT03486548 , Registered 3 April 2018.",2021,"The SNB group significantly had lower median resting pain scores at 6, 12, and 18 h: the control group, 1 (0-4.5), 3 (0-5), and 3 (2-5); the intervention group, 0 (0-0), 0 (0-3), and 1 (0-3); p-values, 0.012, 0.021, and 0.010, respectively.","['50 patients susceptible to the adverse effects of NSAIDs undergoing unilateral TKAs', 'patients susceptible to the adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs', 'total knee arthroplasties (TKA) in patients susceptible to the adverse effects of NSAIDs']","['spinal anesthesia, adductor canal blocks, and periarticular infiltration', 'low-concentration sciatic nerve block to total knee arthroplasty', 'dexamethasone [5\u2009mg', 'bupivacaine', 'dexamethasone', 'adductor canal blocks', 'popliteal-sciatic nerve block (SNB) and dexamethasone', 'SNB']","['Movement-evoked pain scores', 'median resting pain scores', 'mean morphine consumption 24\u2009h', 'motor function', 'motor weakness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C3714552', 'cui_str': 'Debility'}]",50.0,0.311838,"The SNB group significantly had lower median resting pain scores at 6, 12, and 18 h: the control group, 1 (0-4.5), 3 (0-5), and 3 (2-5); the intervention group, 0 (0-0), 0 (0-3), and 1 (0-3); p-values, 0.012, 0.021, and 0.010, respectively.","[{'ForeName': 'Busara', 'Initials': 'B', 'LastName': 'Sirivanasandha', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkok Noi, Bangkok, 10700, Thailand. busarasiri@gmail.com.'}, {'ForeName': 'Kulwadee', 'Initials': 'K', 'LastName': 'Sutthivaiyakit', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkok Noi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Thippatai', 'Initials': 'T', 'LastName': 'Kerdchan', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkok Noi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Suppachai', 'Initials': 'S', 'LastName': 'Poolsuppasit', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkok Noi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Suwimon', 'Initials': 'S', 'LastName': 'Tangwiwat', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkok Noi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Pathom', 'Initials': 'P', 'LastName': 'Halilamien', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkok Noi, Bangkok, 10700, Thailand.'}]",BMC anesthesiology,['10.1186/s12871-021-01491-7']
1299,34773985,"High-protein intake and early exercise in adult intensive care patients: a prospective, randomized controlled trial to evaluate the impact on functional outcomes.","BACKGROUND


We evaluated the efficacy of high protein intake and early exercise versus standard nutrition care and routine physiotherapy on the outcome of critically ill patients.
METHODS


We randomized mechanically ventilated patients expected to stay in the intensive care unit (ICU) for 4 days. We used indirect calorimetry to determine energy expenditure and guide caloric provision to the patients randomized to the high protein and early exercise (HPE) group and the control group. Protein intakes were 1.48 g/kg/day and 1.19 g/kg/day medians respectively; while the former was submitted to two daily sessions of cycle ergometry exercise, the latter received routine physiotherapy. We evaluated the primary outcome physical component summary (PCS) score at 3 and 6 months) and the secondary outcomes (handgrip strength at ICU discharge and ICU and hospital mortality).
RESULTS


We analyzed 181 patients in the HPE (87) and control (94) group. There was no significant difference between groups in relation to calories received. However, the amount of protein received by the HPE group was significantly higher than that received by the control group (p < 0.0001). The PCS score was significantly higher in the HPE group at 3 months (p = 0.01) and 6 months (p = 0.01). The mortality was expressively higher in the control group. We found an independent association between age and 3-month PCS and that between age and group and 6-month PCS.
CONCLUSION


This study showed that a high-protein intake and resistance exercise improved the physical quality of life and survival of critically ill patients.
TRIAL REGISTRATION


Research Ethics Committee of Hospital São Domingos: Approval number 1.487.683, April 09, 2018. The study protocol was registered in ClinicalTrials.gov ( NCT03469882 , March 19,2018).",2021,The PCS score was significantly higher in the HPE group at 3 months (p = 0.01) and 6 months (p = 0.01).,"['critically ill patients', 'adult intensive care patients', 'We randomized mechanically ventilated patients expected to stay in the intensive care unit (ICU) for 4\u2009days', '181 patients in the HPE (87) and control (94) group']","['HPE', 'high protein intake and early exercise versus standard nutrition care and routine physiotherapy', 'High-protein intake and early exercise', 'resistance exercise', 'high protein and early exercise (HPE']","['PCS score', 'Protein intakes', 'physical quality of life and survival', 'mortality', 'physical component summary (PCS) score at 3 and 6\u2009months) and the secondary outcomes (handgrip strength at ICU discharge and ICU and hospital mortality']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1258068', 'cui_str': 'Nutrition management'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",,0.0277398,The PCS score was significantly higher in the HPE group at 3 months (p = 0.01) and 6 months (p = 0.01).,"[{'ForeName': 'José Raimundo Araujo', 'Initials': 'JRA', 'LastName': 'de Azevedo', 'Affiliation': 'Intensive Care Unit, Hospital São Domingos, Av. Jerônimo de Albuquerque, 540 - Bequimão, São Luís, MA, 65060-645, Brazil. jrazevedo47@gmail.com.'}, {'ForeName': 'Hugo César Martins', 'Initials': 'HCM', 'LastName': 'Lima', 'Affiliation': 'Intensive Care Unit, Hospital São Domingos, Av. Jerônimo de Albuquerque, 540 - Bequimão, São Luís, MA, 65060-645, Brazil.'}, {'ForeName': 'Pedro Henrique Dias Brasiliense', 'Initials': 'PHDB', 'LastName': 'Frota', 'Affiliation': 'Intensive Care Unit, Hospital São Domingos, Av. Jerônimo de Albuquerque, 540 - Bequimão, São Luís, MA, 65060-645, Brazil.'}, {'ForeName': 'Ivna Raquel Olimpio Moreira', 'Initials': 'IROM', 'LastName': 'Nogueira', 'Affiliation': 'Intensive Care Unit, Hospital São Domingos, Av. Jerônimo de Albuquerque, 540 - Bequimão, São Luís, MA, 65060-645, Brazil.'}, {'ForeName': 'Suellen Christine', 'Initials': 'SC', 'LastName': 'de Souza', 'Affiliation': 'Intensive Care Unit, Hospital São Domingos, Av. Jerônimo de Albuquerque, 540 - Bequimão, São Luís, MA, 65060-645, Brazil.'}, {'ForeName': 'Erika Arana Arraes', 'Initials': 'EAA', 'LastName': 'Fernandes', 'Affiliation': 'Intensive Care Unit, Hospital São Domingos, Av. Jerônimo de Albuquerque, 540 - Bequimão, São Luís, MA, 65060-645, Brazil.'}, {'ForeName': 'Adlyene Muniz', 'Initials': 'AM', 'LastName': 'Cruz', 'Affiliation': 'Intensive Care Unit, Hospital São Domingos, Av. Jerônimo de Albuquerque, 540 - Bequimão, São Luís, MA, 65060-645, Brazil.'}]",BMC anesthesiology,['10.1186/s12871-021-01492-6']
1300,34781708,Cilostazol Versus Aspirin on White Matter Changes in Cerebral Small Vessel Disease: A Randomized Controlled Trial.,"BACKGROUND AND PURPOSE


Cerebral small vessel disease is characterized by progressive cerebral white matter changes (WMCs). This study aimed to compare the effects of cilostazol and aspirin on changes in WMC volume in patients with cerebral small vessel disease.
METHODS


In a multicenter, double-blind, randomized controlled trial, participants with moderate or severe WMCs and at least one lacunar infarction detected on brain magnetic resonance imaging were randomly assigned to the cilostazol and aspirin groups in a 1:1 ratio. Cilostazol slow release (200 mg) or aspirin (100 mg) capsules were administered once daily for 2 years. The primary outcome was the change in WMC volume on magnetic resonance images from baseline to 2 years. Secondary imaging outcomes include changes in the number of lacunes or cerebral microbleeds, fractional anisotropy, and mean diffusivity on diffusion tensor images, and brain atrophy. Secondary clinical outcomes include all ischemic strokes, all ischemic vascular events, and changes in cognition, motor function, mood, urinary symptoms, and disability.
RESULTS


Between July 2013 and August 2016, 256 participants were randomly assigned to the cilostazol (n=127) and aspirin (n=129) groups. Over 2 years, the percentage of WMC volume to total WM volume and the percentage of WMC volume to intracranial volume increased in both groups, but neither analysis showed significant differences between the groups. The peak height of the mean diffusivity histogram in normal-appearing WMs was significantly reduced in the aspirin group compared with the cilostazol group. Cilostazol significantly reduced the risk of ischemic vascular event compared with aspirin (0.5 versus 4.5 cases per 100 person-years; hazard ratio, 0.11 [95% CI, 0.02-0.89]).
CONCLUSIONS


There was no significant difference between the effects of cilostazol and aspirin on WMC progression in patients with cerebral small vessel disease. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01932203.",2022,There was no significant difference between the effects of cilostazol and aspirin on WMC progression in patients with cerebral small vessel disease.,"['participants with moderate or severe WMCs and at least one lacunar infarction detected on brain magnetic resonance imaging', 'Between July 2013 and August 2016, 256 participants', 'patients with cerebral small vessel disease', 'Cerebral Small Vessel Disease']","['cilostazol and aspirin', 'Cilostazol Versus Aspirin', 'cilostazol', 'Cilostazol', 'Cilostazol slow release (200 mg) or aspirin', 'aspirin']","['ischemic strokes, all ischemic vascular events, and changes in cognition, motor function, mood, urinary symptoms, and disability', 'WMC progression', 'peak height of the mean diffusivity histogram in normal-appearing WMs', 'percentage of WMC volume to total WM volume and the percentage of WMC volume to intracranial volume', 'change in WMC volume on magnetic resonance images', 'risk of ischemic vascular event', 'number of lacunes or cerebral microbleeds, fractional anisotropy, and mean diffusivity on diffusion tensor images, and brain atrophy']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0333559', 'cui_str': 'Lacunar infarction'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2733158', 'cui_str': 'Small vessel cerebrovascular disease'}]","[{'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0175702', 'cui_str': 'Williams syndrome'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}]",256.0,0.423603,There was no significant difference between the effects of cilostazol and aspirin on WMC progression in patients with cerebral small vessel disease.,"[{'ForeName': 'Byeong C', 'Initials': 'BC', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Chonnam National University Medical School, Gwangju, Republic of Korea (B.C.K.).'}, {'ForeName': 'Young Chul', 'Initials': 'YC', 'LastName': 'Youn', 'Affiliation': 'Department of Neurology, Chung-Ang University College of Medicine, Seoul, Republic of Korea (Y.C.Y.).'}, {'ForeName': 'Jee Hyang', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Neurology, Ewha Womans University School of Medicine, Seoul, Republic of Korea (J.H.J.).'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Han', 'Affiliation': 'Department of Neurology, Myongji Hospital, Hanyang University College of Medicine, Goyang, Republic of Korea (H.J.H.).'}, {'ForeName': 'Jong Hun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea (J.H.K.).'}, {'ForeName': 'Jae-Hong', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea (J.-H.L.).'}, {'ForeName': 'Kee Hyung', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea (K.H.P.).'}, {'ForeName': 'Kyung Won', 'Initials': 'KW', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Dong-A University College of Medicine and Department of Translational Biomedical Sciences, Graduate School of Dong-A University, Busan, Republic of Korea (K.W.P.).'}, {'ForeName': 'Eun-Joo', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Pusan National University Hospital, Pusan National University School of Medicine and Medical Research Institute, Busan, Republic of Korea (E.-J.K.).'}, {'ForeName': 'Mi Sun', 'Initials': 'MS', 'LastName': 'Oh', 'Affiliation': 'Department of Neurology, Hallym University Sacred Heart Hospital (M.S.O.), Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'YongSoo', 'Initials': 'Y', 'LastName': 'Shim', 'Affiliation': ""Department of Neurology, The Catholic University of Korea Eunpyeong St. Mary's Hospital, Seoul, Republic of Korea (Y.S.).""}, {'ForeName': 'Jong-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Engineering (J.-M.L., Y.-H.C., G.P.), Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Yong-Ho', 'Initials': 'YH', 'LastName': 'Choi', 'Affiliation': 'Department of Biomedical Engineering (J.-M.L., Y.-H.C., G.P.), Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Gilsoon', 'Initials': 'G', 'LastName': 'Park', 'Affiliation': 'Department of Biomedical Engineering (J.-M.L., Y.-H.C., G.P.), Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Sohui', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Electronic Engineering (S.K.), Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Hyun Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Wonkwang University School of Medicine, Iksan, Republic of Korea (H.Y.P.).'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Yoon', 'Affiliation': 'Department of Neurology, Konyang University College of Medicine, Daejeon, Republic of Korea (B.Y.).'}, {'ForeName': 'Soo Jin', 'Initials': 'SJ', 'LastName': 'Yoon', 'Affiliation': 'Department of Neurology, Eulji University Hospital, Eulji University School of Medicine, Daejeon, Republic of Korea (S.J.Y.).'}, {'ForeName': 'Soo-Jin', 'Initials': 'SJ', 'LastName': 'Cho', 'Affiliation': 'Department of Neurology, Hallym University Dongtan Sacred Heart Hospital (S.-J.C.), Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Key Chung', 'Initials': 'KC', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Kyung Hee University School of Medicine, Seoul, Republic of Korea (K.C.P.).'}, {'ForeName': 'Duk L', 'Initials': 'DL', 'LastName': 'Na', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea (D.L.N.).'}, {'ForeName': 'Sun Ah', 'Initials': 'SA', 'LastName': 'Park', 'Affiliation': 'Department of Anatomy and Department of Neurology, Ajou University School of Medicine, Suwon, Republic of Korea (S.A.P.).'}, {'ForeName': 'Seong Hye', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Neurology, Inha University School of Medicine, Incheon, Republic of Korea (S.H.C.).'}]",Stroke,['10.1161/STROKEAHA.121.035766']
1301,34786956,"Tanezumab for chronic low back pain: a long-term, randomized, celecoxib-controlled Japanese Phase III safety study.","Aim & methods:  This trial investigated long-term (56-week treatment/24-week follow-up) use of subcutaneous tanezumab (5 or 10 mg every 8 weeks) or oral celecoxib (200 mg/day) in Japanese patients with chronic low back pain.  Results & conclusion:  Tanezumab safety was consistent with previous studies, except overall adverse events (tanezumab 5 mg = 63.0%, tanezumab 10 mg = 54.8%, celecoxib = 67.4%) and events of abnormal peripheral sensation (tanezumab 5 mg = 9.8%, tanezumab 10 mg = 4.3%, celecoxib = 4.3%) were more frequent with 5 mg than 10 mg tanezumab. Joint safety event rates were 1.1% for tanezumab 5 mg, 2.2% for tanezumab 10 mg and 0% for celecoxib. All treatments improved pain and function throughout the treatment period.  Clinical trial registration number:  NCT02725411.",2022,"Joint safety event rates were 1.1% for tanezumab 5 mg, 2.2% for tanezumab","['chronic low back pain', 'Japanese patients with chronic low back pain']","['oral celecoxib', 'Tanezumab', 'subcutaneous tanezumab', 'tanezumab', 'celecoxib']","['pain and function', 'Joint safety event rates', 'overall adverse events', 'abnormal peripheral sensation', 'Tanezumab safety']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C2346819', 'cui_str': 'tanezumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C2346819', 'cui_str': 'tanezumab'}]",,0.270171,"Joint safety event rates were 1.1% for tanezumab 5 mg, 2.2% for tanezumab","[{'ForeName': 'Shin-Ichi', 'Initials': 'SI', 'LastName': 'Konno', 'Affiliation': 'Department of Orthopaedic Surgery, Fukushima Medical University, Fukushima, 960-1295, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Nikaido', 'Affiliation': 'Department of Orthopaedic Surgery, Fukushima Medical University, Fukushima, 960-1295, Japan.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Markman', 'Affiliation': 'Translational Pain Research Program, Department of Neurosurgery, University of Rochester Medical Center, Rochester, NY\xa014618, USA.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ohta', 'Affiliation': 'Pfizer R&D Japan, Tokyo, 151-8589, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Machida', 'Affiliation': 'Pfizer R&D Japan, Tokyo, 151-8589, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Isogawa', 'Affiliation': 'Pfizer R&D Japan, Tokyo, 151-8589, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yoshimatsu', 'Affiliation': 'Pfizer R&D Japan, Tokyo, 151-8589, Japan.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Viktrup', 'Affiliation': 'Neuroscience Business Unit, Eli Lilly & Company, Indianapolis, IN\xa046225, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Brown', 'Affiliation': 'Pfizer Global Product Development, Pfizer Inc., Groton, CT\xa006340, USA.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'Pfizer Global Product Development, Pfizer Inc., Groton, CT\xa006340, USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Verburg', 'Affiliation': 'Pfizer Global Product Development, Pfizer Inc., Groton, CT\xa006340, USA.'}]",Pain management,['10.2217/pmt-2021-0040']
1302,34786952,Modulation of signal transduction gene expression following pulsed radiofrequency in dorsal root ganglia and pregabalin therapy.,"Introduction:  A randomized controlled study was conducted to assess modulation of signal transduction genes ( PKA ,  PKC  and  ERK ) following integrated multimodal approach encompassing pulsed radiofrequency treatment (PRF) of dorsal root ganglion and pregabalin in thoracic postherpetic neuralgia (PHN). Clinical variables such as pain intensity and quality of life were also explored.  Material & methods:  A total of 40 Patients of PHN were recruited. 20 patients randomly assigned to each of the two groups, group PP administered PRF with pregabalin and group SP administered pregabalin alone.  Results:  Significant downregulation of  PKA  and  ERK  observed in group PP at end of 10th week (p < 0.05). A significantly positive correlation demonstrated between Visual analog scale scores and signal transduction genes expression in PHN patients.  Conclusion:  Downregulation of all three signal transduction genes was observed following the integrated multimodal approach; however, significant downregulation was observed with  PKA  and  ERK  only. A positive correlation observed between signal transduction gene expression and visual analog scale scores signify their role in the pathogenesis of PHN.",2022,Significant downregulation of  PKA  and  ERK  observed in group PP at end of 10th week (p < 0.05).,"['total of\xa040 Patients of PHN were recruited', '20 patients', 'thoracic postherpetic neuralgia (PHN']","['pulsed radiofrequency treatment (PRF) of dorsal root ganglion and pregabalin', 'PRF with pregabalin and group SP administered pregabalin alone', 'signal transduction genes ( PKA ,  PKC  and  ERK ']","['Visual analog\xa0scale scores and signal transduction genes expression', 'pain intensity and quality of life', 'PKA  and  ERK']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017070', 'cui_str': 'Structure of spinal nerve ganglion'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0033374', 'cui_str': 'Prolactin releasing factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0010531', 'cui_str': 'Cyclic AMP-Dependent Protein Kinase'}, {'cui': 'C0033634', 'cui_str': 'Protein kinase C'}, {'cui': 'C0752312', 'cui_str': 'Mitogen-Activated Protein Kinases'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010531', 'cui_str': 'Cyclic AMP-Dependent Protein Kinase'}, {'cui': 'C0752312', 'cui_str': 'Mitogen-Activated Protein Kinases'}]",40.0,0.0346797,Significant downregulation of  PKA  and  ERK  observed in group PP at end of 10th week (p < 0.05).,"[{'ForeName': 'Ashok Kumar', 'Initials': 'AK', 'LastName': 'Saxena', 'Affiliation': 'Department of Anaesthesiology, Critical care & Pain Medicine, University College of Medical Sciences & Guru Tegh Bahadaur Hospital, Delhi, 110095, India.'}, {'ForeName': 'Anshul', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology, Critical care & Pain Medicine, University College of Medical Sciences & Guru Tegh Bahadaur Hospital, Delhi, 110095, India.'}, {'ForeName': 'Geetanjali T', 'Initials': 'GT', 'LastName': 'Chilkoti', 'Affiliation': 'Department of Anaesthesiology, Critical care & Pain Medicine, University College of Medical Sciences & Guru Tegh Bahadaur Hospital, Delhi, 110095, India.'}, {'ForeName': 'Tusha', 'Initials': 'T', 'LastName': 'Sharma', 'Affiliation': 'Department of Environmental Biochemistry & Molecular Biology, University College of Medical Sciences & Guru Tegh Bahadur Hospital, Dilshad garden, Delhi, 110095, India.'}, {'ForeName': 'Basu Dev', 'Initials': 'BD', 'LastName': 'Banerjee', 'Affiliation': 'Department of Environmental Biochemistry & Molecular Biology, University College of Medical Sciences & Guru Tegh Bahadur Hospital, Dilshad garden, Delhi, 110095, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, Critical care & Pain Medicine, University College of Medical Sciences & Guru Tegh Bahadaur Hospital, Delhi, 110095, India.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Singhal', 'Affiliation': 'Department of Dermatology, University College of Medical Sciences & G.T.B. Hospital, Dilshad Garden, Delhi, 110095, India.'}]",Pain management,['10.2217/pmt-2021-0057']
1303,34787930,Hope and advance care planning in advanced cancer: Is there a relationship?,"BACKGROUND


Clinicians often cite a fear of giving up hope as a reason they defer advance care planning (ACP) among patients with advanced cancer. The objective of this study was to determine whether engagement in ACP affects hope in these patients.
METHODS


This was a secondary analysis of a randomized controlled trial of primary palliative care in advanced cancer. Patients who had not completed ACP at baseline were included in the analysis. ACP was assessed in the forms of an end-of-life (EOL) conversation with one's oncologist and completion of a living will or advance directive (AD). Measurements were obtained at baseline and at 3 months. Hope was measured using the Herth Hope Index (HHI) (range, 12-48; higher scores indicate higher hope). Multivariate regression was performed to assess associations between ACP and hope, controlling for baseline HHI score, study randomization, patient age, religious importance, education, marital status, socioeconomic status, time since cancer diagnosis, pain/symptom burden (Edmonton Symptom Assessment System), and anxiety/depression score (Hospital Anxiety and Depression Scale)-all variables known to be associated with ACP and/or hope.
RESULTS


In total, 672 patients with advanced cancer were enrolled in the overall study. The mean age was 69 ± 10 years, and the most common cancer types were lung cancer (36%), gastrointestinal cancer (20%) and breast/gynecologic cancers (16%). In this group, 378 patients (56%) had not had an EOL conversation at baseline, of whom 111 of 378 (29%) reported having an EOL conversation by 3 months. Hope was not different between patients who did or did not have an EOL conversation over the study period (mean ± standard deviation ∆HHI, 0.20 ± 5.32 vs -0.53 ± 3.80, respectively; P = .136). After multivariable adjustment, hope was significantly increased in patients who had engaged in an EOL conversation (adjusted mean difference in ∆HHI, 0.95; 95% CI, 0.08-1.82; P = .032). Similarly, of 216 patients (32%) without an AD at baseline, 67 (31%) had subsequently completed an AD. Unadjusted hope was not different between those who did and did not complete an AD (∆HHI, 0.20 ± 3.89 vs -0.91 ± 4.50, respectively; P = .085). After adjustment, hope was significantly higher in those who completed an AD (adjusted mean difference in ∆HHI, 1.31; 95% CI, 0.13-2.49; P = .030).
CONCLUSIONS


The current results demonstrate that hope is not decreased after engagement in ACP and indeed may be increased. These findings may provide reassurance to clinicians who are apprehensive about having these important and difficult conversations.
LAY SUMMARY


Many oncologists defer advance care planning (ACP) out of concern for giving up hope. This study demonstrates that hope is not decreased in patients who have engaged in ACP either as a conversation with their oncologists or by completing an advance directive. With this information, providers may feel more comfortable having these important conversations with their patients.",2022,"Unadjusted hope was not different between those who did and did not complete an AD (∆HHI, 0.20 ± 3.89 vs -0.91 ± 4.50, respectively; P = .085).","['patients who have engaged in ACP either as a conversation with their oncologists or by completing an advance directive', 'primary palliative care in advanced cancer', 'Patients who had not completed ACP at baseline were included in the analysis', '216 patients (32%) without an AD at baseline, 67 (31%) had subsequently completed an AD', 'advanced cancer', 'The mean age was 69 ± 10 years, and the most common cancer types were lung cancer (36%), gastrointestinal cancer (20%) and breast/gynecologic cancers (16', '672 patients with advanced cancer', 'patients with advanced cancer']",[],"['ACP', 'baseline HHI score, study randomization, patient age, religious importance, education, marital status, socioeconomic status, time since cancer diagnosis, pain/symptom burden (Edmonton Symptom Assessment System), and anxiety/depression score (Hospital Anxiety and Depression Scale)-all variables', 'Herth Hope Index (HHI', 'EOL conversation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C1444661', 'cui_str': 'Stopped before completion'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}]",[],"[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3472649', 'cui_str': 'Edmonton symptom assessment system'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",672.0,0.404781,"Unadjusted hope was not different between those who did and did not complete an AD (∆HHI, 0.20 ± 3.89 vs -0.91 ± 4.50, respectively; P = .085).","[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Cohen', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Althouse', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Section of Palliative Care and Medical Ethics, Palliative Research Center and Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Hailey W', 'Initials': 'HW', 'LastName': 'Bulls', 'Affiliation': 'Section of Palliative Care and Medical Ethics, Palliative Research Center and Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'Program on Ethics and Decision Making in Critical Illness, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Chu', 'Affiliation': 'Albert Einstein Cancer Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Margaret Q', 'Initials': 'MQ', 'LastName': 'Rosenzweig', 'Affiliation': 'University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Schenker', 'Affiliation': 'Section of Palliative Care and Medical Ethics, Palliative Research Center and Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Cancer,['10.1002/cncr.34034']
1304,34789713,A Prospective Single-Center Study of the Effects of Repetitive Transcranial Magnetic Stimulation at 2-Week Follow-Up in 17 Patients with Chronic Orofacial Pain Diagnosed by Infrared Thermography.,"BACKGROUND Infrared thermography is a diagnostic method used to monitor acute and chronic orofacial pain syndrome. Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive brain stimulation. This prospective study from a single center aimed to investigate the effects of rTMS and used infrared thermography as a confirmatory test of orofacial pain. MATERIAL AND METHODS We used infrared thermography to examine the incidence of inflammatory changes as orofacial pain triggers. During the analysis of rTMS effects on patients with orofacial pain, we compared the decrease in pain and the thermal difference in the study group (n=17) and in the research group (n=13). RESULTS In the control group (n=13), there were no statistically significant changes. Both groups showed a significant decrease in self-reported pain. Numerical pain rating scores were significantly lower after S2 stimulation than after S1/M1 (P=0.0071) or sham (P=0.0187) stimulation. The Brief Pain Inventory scores were also lower 3 to 5 days after S2 stimulation than at the pretreatment baseline (P=0.0127 for the intensity of pain and p=0.0074 for the interference of pain), and after S1/M1 (P=0.001 and P=0.0001) and sham (P=0.0491 and P=0.0359) stimulations. CONCLUSIONS The findings from this study support the role of infrared thermography for the diagnosis of chronic orofacial pain, and showed that on the first and fifth days of rTMS therapy in the study group there was a significant reduction of the thermography findings when compared with the control group without rTMS therapy.",2021,Numerical pain rating scores were significantly lower after S2 stimulation than after S1/M1 (P=0.0071) or sham (P=0.0187) stimulation.,"['patients with orofacial pain', '17 Patients with Chronic Orofacial Pain Diagnosed by Infrared Thermography', 'orofacial pain']","['Repetitive transcranial magnetic stimulation (rTMS', 'Repetitive Transcranial Magnetic Stimulation', 'rTMS and used infrared thermography', 'Infrared thermography']","['self-reported pain', 'chronic orofacial pain', 'pain', 'Brief Pain Inventory scores', 'Numerical pain rating scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178782', 'cui_str': 'Orofacial Pain'}, {'cui': 'C4546211', 'cui_str': 'Chronic orofacial pain'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0039810', 'cui_str': 'Thermography'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0039810', 'cui_str': 'Thermography'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4546211', 'cui_str': 'Chronic orofacial pain'}, {'cui': 'C2732532', 'cui_str': 'Brief pain inventory score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0198714,Numerical pain rating scores were significantly lower after S2 stimulation than after S1/M1 (P=0.0071) or sham (P=0.0187) stimulation.,"[{'ForeName': 'Jitka', 'Initials': 'J', 'LastName': 'Fricova', 'Affiliation': 'Department of Anestesiology, Resuscitation and Intensive Medicine, Pain Management Center, First Faculty of Medicine, General University Hospital, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Markéta', 'Initials': 'M', 'LastName': 'Janatova', 'Affiliation': 'Department of Rehabilitation Medicine, General University Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Albrecht', 'Affiliation': 'Department of Psychiatry, General University Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Tadeas', 'Initials': 'T', 'LastName': 'Mares', 'Affiliation': 'Department of Psychiatry, General University Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rokyta', 'Affiliation': 'Department of Physiology, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Vaclav', 'Initials': 'V', 'LastName': 'Masopust', 'Affiliation': 'Department of Neurosurgery, Military Faculty Hospital, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Anders', 'Affiliation': 'Department of Psychiatry, General University Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.933017']
1305,34789711,Optimized scheme for paired transverse corrective forces in S-shaped scoliosis via ultrasound and application in Chêneau brace: a pilot study.,"BACKGROUND


There is currently no consensus on the optimal positions of the transverse corrective forces (TCFs) for scoliosis braces.
OBJECTIVES


This study aimed to explore an optimal scheme of placing paired TCF for S-shaped adolescent idiopathic scoliosis and its feasibility in Chêneau brace (CB) treatment.
STUDY DESIGN


Cross-over feasibility pilot trial.
METHODS


Ten S-shaped adolescent idiopathic scoliosis participants were invited to receive four tests with different paired TCF positions under ultrasound. The positions of the paired TCF were test 1: thoracic apical vertebra (AV), lumbar AV; test 2: 2 cm inferior to thoracic AV, lumbar AV; test 3: thoracic AV, 2 cm superior to lumbar AV; and test 4: 2 cm inferior to thoracic AV, 2 cm superior to lumbar AV. The test scheme with the highest mean in-force correction rate (IFCR) for the thoracic spinous process angle (SPA) was further applied in the CB fabrication of 4 additional participants.
RESULTS


A significant higher mean IFCR of the thoracic SPA of 63.6% was found in test 2 (P < 0.001), which also contributed to its higher overall IFCR of the SPA of 64.6% (P = 0.001). Moreover, the mean in-brace correction rates for the thoracic and overall curves in CB were 46.4% and 51.8%, respectively. No adverse events were reported.
CONCLUSIONS


Placing paired TCF at the lumbar AV and 2 cm inferior to the thoracic AV achieved better treatment efficacy than other schemes. The practical application of this scheme on the CB was feasible.",2022,"The test scheme with the highest mean in-force correction rate (IFCR) for the thoracic spinous process angle (SPA) was further applied in the CB fabrication of 4 additional participants.
",['Ten S-shaped adolescent idiopathic scoliosis participants'],"['placing paired TCF', 'Chêneau brace (CB', 'thoracic AV, 2 cm superior to lumbar AV; and test 4: 2 cm inferior to thoracic']","['overall IFCR', 'mean IFCR of the thoracic SPA', 'mean in-brace correction rates', 'adverse events']","[{'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}]","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0223192', 'cui_str': 'Structure of spinous process of thoracic vertebra'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.150881,"The test scheme with the highest mean in-force correction rate (IFCR) for the thoracic spinous process angle (SPA) was further applied in the CB fabrication of 4 additional participants.
","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Xia', 'Affiliation': 'Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Christina Zonghao', 'Initials': 'CZ', 'LastName': 'Ma', 'Affiliation': 'Department of Biomedical Engineering, the Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Ahmed S A', 'Initials': 'ASA', 'LastName': 'Youssef', 'Affiliation': 'Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Ultrasound, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Youbin', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Medical Ultrasound, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Guoli', 'Initials': 'G', 'LastName': 'Zhu', 'Affiliation': 'School of Mechanical Science and Engineering, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Prosthetics and orthotics international,['10.1097/PXR.0000000000000064']
1306,34801917,"A pilot, feasibility, randomised controlled trial of midodrine as adjunctive vasopressor for low-dose vasopressor-dependent hypotension in intensive care patients: The MAVERIC study.","PURPOSE


To assess the feasibility and physiological efficacy of adjunctive midodrine in patients with vasopressor-dependent hypotension.
MATERIALS AND METHODS


This was a pilot, open label, randomised controlled trial. Patients were enrolled from two tertiary intensive care units on low dose intravenous vasopressor therapy for more than 24 h. We randomly assigned patients to receive either adjunctive midodrine (10 mg every 8 h) or usual care. The primary efficacy outcome was time to cessation of intravenous vasopressor therapy. Secondary outcomes included protocol compliance, ICU and hospital length of stay.
RESULTS


We screened 381 patients over 22-months and enrolled 62 (32 in midodrine group, 30 in usual care group). Median time to cessation of vasopressor infusion was 16.5 h for midodrine vs 19 h for usual care (p = 0.22). Time in ICU (50 [25.50, 74.00] hours for midodrine v 59 [38.50, 93.25] hours for usual care, p = 0.14) and hospital length of stay (9 days vs. 7.5 days, p = 0.92) were similar. Protocol compliance was 96.9%. One patient ceased midodrine early due to symptomatic bradycardia.
CONCLUSIONS


Adjunctive midodrine therapy was feasible with acceptable compliance, duration of therapy, and safety profile. However, at the chosen dose, there was no evidence of physiological or clinical efficacy.",2022,Median time to cessation of vasopressor infusion was 16.5 h for midodrine vs 19 h for usual care (p = 0.22).,"['381 patients over 22-months and enrolled 62 (32 in midodrine group, 30 in usual care group', 'Patients were enrolled from two tertiary intensive care units on low dose intravenous vasopressor therapy for more than 24\xa0h', 'patients with vasopressor-dependent hypotension', 'intensive care patients']","['adjunctive midodrine (10\xa0mg every 8\xa0h) or usual care', 'adjunctive midodrine', 'midodrine']","['Protocol compliance', 'acceptable compliance, duration of therapy, and safety profile', 'protocol compliance, ICU and hospital length of stay', 'hospital length of stay', 'time to cessation of intravenous vasopressor therapy', 'Time in ICU', 'physiological or clinical efficacy', 'Median time to cessation of vasopressor infusion']","[{'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026078', 'cui_str': 'Midodrine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]","[{'cui': 'C0026078', 'cui_str': 'Midodrine'}]","[{'cui': 'C0525058', 'cui_str': 'Protocol Compliance'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]",381.0,0.0704155,Median time to cessation of vasopressor infusion was 16.5 h for midodrine vs 19 h for usual care (p = 0.22).,"[{'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Costa-Pinto', 'Affiliation': 'Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia; Department of Critical Care, Department of Medicine, the University of Melbourne, Parkville, Victoria, Australia. Electronic address: rahul.costa-pinto@austin.org.au.'}, {'ForeName': 'Zhen-Ti', 'Initials': 'ZT', 'LastName': 'Yong', 'Affiliation': 'Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Yanase', 'Affiliation': 'Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia; Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Young', 'Affiliation': 'Department of Intensive Care, Wellington Regional Hospital, 49 Riddiford Street, Newtown, Wellington, New Zealand.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Udy', 'Affiliation': 'Department of Intensive Care, The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, Australia; Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Department of Intensive Care, Wellington Regional Hospital, 49 Riddiford Street, Newtown, Wellington, New Zealand; Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Medical Research Institute of New Zealand, Private Bag, 7902, Wellington, New Zealand; Department of Critical Care, Department of Medicine, the University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia; Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Department of Intensive Care, Royal Melbourne Hospital, Melbourne, Victoria, Australia; Department of Critical Care, Department of Medicine, the University of Melbourne, Parkville, Victoria, Australia; Data Analytics Research and Evaluation Centre, The University of Melbourne and Austin Hospital, Melbourne, Australia.'}]",Journal of critical care,['10.1016/j.jcrc.2021.11.004']
1307,34816187,SMARThealth Pregnancy: Feasibility and Acceptability of a Complex Intervention for High-Risk Pregnant Women in Rural India: Protocol for a Pilot Cluster Randomised Controlled Trial.,"Introduction:  India is in the process of a major epidemiological transition towards non-communicable diseases. Cardiovascular disease (CVD) is the leading cause of death in women in India. Predisposing independent risk factors include pregnancy-related conditions, e.g., hypertensive disorders of pregnancy (HDP) and gestational diabetes (GDM) - also associated with significant perinatal mortality and morbidity. Early identification, referral and management of pregnant women at increased risk of future CVD may offer opportunities for prevention. In rural India, Community Health Workers (CHWs) provide most antenatal and postnatal care. Innovative solutions are required to address integrated care for rural women during transitions between antenatal, postnatal and general health services. The George Institute's SMARThealth Programme has shown that CHWs in rural India screening non-pregnant adults for cardiovascular risk, using a decision support system, is feasible. Building on this, we developed a targeted training programme for CHWs and a complex system-level intervention that uses mobile clinical decision support for CHWs and primary care doctors to screen high-risk pregnant women. In addition to addressing HDP and GDM, the intervention also screens for anaemia in pregnancy.  Methods/Design:  A pilot study will be undertaken in two diverse rural districts of India: Jhajjar (Haryana) and Guntur (Andhra Pradesh). Two Primary Health Centre clusters will be randomised to intervention or control groups at each study site. The primary objective of this pilot study is to explore the feasibility and acceptability of the SMARThealth Pregnancy intervention. Secondary objectives are to estimate: (a) prevalence rates of moderate to severe anaemia, HDPs and GDM at the study sites; (b) referral and follow-up rates, and (c) mean haemoglobin and blood pressure values at the routine 6 week postnatal visit. A process evaluation will be conducted to explore the acceptability of the SMARThealth Pregnancy intervention for pregnant women and healthcare workers using qualitative methods.  Discussion:  It is anticipated that the findings of this pilot study will help determine the feasibility and acceptability of the SMARThealth Pregnancy intervention, and highlight how the intervention might be further developed for evaluation in a larger, cluster randomised controlled trial.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier: NCT03968952.",2021,"It is anticipated that the findings of this pilot study will help determine the feasibility and acceptability of the SMARThealth Pregnancy intervention, and highlight how the intervention might be further developed for evaluation in a larger, cluster randomised controlled trial.  ","['women in India', 'High-Risk Pregnant Women in Rural India', 'pregnant women and healthcare workers using qualitative methods', 'and primary care doctors to screen high-risk pregnant women', 'two diverse rural districts of India: Jhajjar (Haryana) and Guntur (Andhra Pradesh', 'pregnant women', 'rural women during transitions between antenatal, postnatal and general health services']","['Complex Intervention', 'targeted training programme for CHWs and a complex system-level intervention that uses mobile clinical decision support for CHWs']","['prevalence rates of moderate to severe anaemia, HDPs and GDM at the study sites; (b) referral and follow-up rates, and (c) mean haemoglobin and blood pressure values', 'perinatal mortality and morbidity', 'hypertensive disorders of pregnancy (HDP) and gestational diabetes (GDM', 'feasibility and acceptability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0579854,"It is anticipated that the findings of this pilot study will help determine the feasibility and acceptability of the SMARThealth Pregnancy intervention, and highlight how the intervention might be further developed for evaluation in a larger, cluster randomised controlled trial.  ","[{'ForeName': 'Shobhana', 'Initials': 'S', 'LastName': 'Nagraj', 'Affiliation': ""Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, United Kingdom.""}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Kennedy', 'Affiliation': ""Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, United Kingdom.""}, {'ForeName': 'Vivekananda', 'Initials': 'V', 'LastName': 'Jha', 'Affiliation': 'The George Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Norton', 'Affiliation': 'The George Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hinton', 'Affiliation': 'THIS Institute (The Healthcare Improvement Studies Institute), Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Kensington, NSW, Australia.'}, {'ForeName': 'Eldho', 'Initials': 'E', 'LastName': 'Rajan', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Arora', 'Affiliation': 'Post Graduate Institute of Medical Science, Rohtak, India.'}, {'ForeName': 'Devarsetty', 'Initials': 'D', 'LastName': 'Praveen', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Hirst', 'Affiliation': ""Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, United Kingdom.""}]",Frontiers in global women's health,['10.3389/fgwh.2021.620759']
1308,34793687,Biomarkers to Predict Response to Inhaled Corticosteroids and Long-Acting Muscarinic Antagonists in Adolescents and Adults with Mild Persistent Asthma.,"Rationale:  Whether biomarkers can be used to predict response to inhaled corticosteroids (ICS) or long-acting muscarinic antagonists (LAMA) in mild persistent asthma is unclear.  Objectives:  In a prespecified exploratory analysis of a randomized clinical trial of 295 participants 12 years of age or older with uncontrolled mild persistent asthma, we sought to identify biomarkers of treatment response after 12 weeks of ICS (mometasone, 200 μg or 220 μg twice/d), LAMA (tiotropium, 5 μg/d), or placebo in adults (⩾18 yr) and adolescents (12-17 yr) separately.  Methods:  The primary outcome was a composite outcome of asthma control (treatment failure, asthma control days, and forced expiratory volume in 1 second [FEV 1 ]). Analyses examined type 2 inflammatory biomarkers and physiologic biomarkers. We assessed the area under the receiver operating characteristic curve (AUC) for response to ICS and LAMA (each versus placebo). An AUC of 0.5 suggests no discrimination, 0.7-0.8 is considered acceptable, more than 0.8-0.9 is considered excellent, and more than 0.9 is considered outstanding.  Results:  In 237 adults, sputum and blood eosinophil levels and fractional exhaled nitric oxide (Fe NO ) each predicted ICS response (AUCs: 0.61 [95% confidence interval (CI), 0.53-0.69], 0.64 [95% CI, 0.56-0.72], and 0.62 [95% CI, 0.54-0.70], respectively; all  P  < 0.01); the AUC for blood eosinophil levels and Fe NO  together was 0.66 (95% CI, 0.58-0.74;  P  < 0.001). In 58 adolescents, the number of positive aeroallergens and total serum immunoglobulin E each predicted ICS response (AUCs: 0.69 [95% CI, 0.52-0.85] and 0.73 [95% CI, 0.58-0.87], respectively; both  P  < 0.03); the AUC for both together was 0.73 (95% CI, 0.58-0.87;  P  = 0.003). After ipratropium bromide, FEV 1  reversibility predicted LAMA response in adults (AUC: 0.61 [95% CI, 0.53-0.69],  P  = 0.007) but not in adolescents.  Conclusions:  The AUCs of the type 2 inflammatory biomarkers and physiological biomarkers we examined may not be high enough to confidently identify individuals with asthma who respond to ICS and LAMA. However, our findings indicate that the biomarkers that predict response to ICS or LAMA may differ in adults versus adolescents with uncontrolled mild persistent asthma. Prospective, biomarker-stratified clinical trials are needed to confirm these findings and to identify first-line controllers tailored for each population.",2022,"In 237 adults, sputum and blood eosinophil levels and FeNO each predicted ICS response (AUCs 0.61 (95% confidence interval [CI], 0.53-0.69), 0.64 (95% CI, 0.56-0.72), and 0.62 (95% CI, 0.54-0.70), respectively; all p-values<0.01); the AUC for blood eosinophil levels and FeNO together = 0.66 (95% CI, 0.58-0.74), p<0.001.","['individuals with asthma who respond to ICS and LAMA', 'Adolescents and Adults with Mild Persistent Asthma', 'in adults (>18 years) and adolescents (12-17 years) separately', 'adults versus adolescents with uncontrolled mild persistent asthma', '200µg or 220µg twice/day', '295 participants >12 years old with uncontrolled mild persistent asthma', '58 adolescents']","['ICS and LAMA', 'ipratropium bromide', 'inhaled corticosteroids (ICS) or long-acting muscarinic antagonists (LAMA', 'LAMA (tiotropium 5µg/day), or placebo', 'ICS (mometasone']","['sputum and blood eosinophil levels and FeNO each predicted ICS response', 'composite outcome of asthma control (treatment failure, asthma control days, and forced expired volume in the first second [FEV1', 'area under curve (AUC', 'FEV1 reversibility predicted LAMA response', 'AUC for blood eosinophil levels', 'number of positive aeroallergens and total serum IgE each predicted ICS response']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1960046', 'cui_str': 'Mild persistent asthma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0700580', 'cui_str': 'ipratropium bromide'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}]","[{'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0449261', 'cui_str': 'Reversibility'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001697', 'cui_str': 'Aeroallergen'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}]",295.0,0.526546,"In 237 adults, sputum and blood eosinophil levels and FeNO each predicted ICS response (AUCs 0.61 (95% confidence interval [CI], 0.53-0.69), 0.64 (95% CI, 0.56-0.72), and 0.62 (95% CI, 0.54-0.70), respectively; all p-values<0.01); the AUC for blood eosinophil levels and FeNO together = 0.66 (95% CI, 0.58-0.74), p<0.001.","[{'ForeName': 'Jerry A', 'Initials': 'JA', 'LastName': 'Krishnan', 'Affiliation': 'University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Lazarus', 'Affiliation': 'University of California, San Francisco, California.'}, {'ForeName': 'Kathryn V', 'Initials': 'KV', 'LastName': 'Blake', 'Affiliation': ""Nemours Children's Health, Jacksonville, Florida.""}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Sorkness', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Ronina', 'Initials': 'R', 'LastName': 'Covar', 'Affiliation': 'National Jewish Health, Denver, Colorado.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Dyer', 'Affiliation': 'Pennsylvania State University, Hershey, Pennsylvania.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Lang', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Njira L', 'Initials': 'NL', 'LastName': 'Lugogo', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Mauger', 'Affiliation': 'Pennsylvania State University, Hershey, Pennsylvania.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'National Jewish Health, Denver, Colorado.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Wenzel', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Cardet', 'Affiliation': 'University of South Florida, Tampa, Florida.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'University of Kansas School of Medicine, Kansas City, Kansas.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Harvard Medical School Brigham & Women's Hospital, Boston, Massachusetts; and.""}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Tonya S', 'Initials': 'TS', 'LastName': 'King', 'Affiliation': 'Pennsylvania State University, Hershey, Pennsylvania.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202105-613OC']
1309,34794121,Can We Modify Maximal Speed Running Posture? Implications for Performance and Hamstring Injury Management.,"PURPOSE


Sprint kinematics have been linked to hamstring injury and performance. This study aimed to examine if a specific 6-week multimodal intervention, combining lumbopelvic control and unning technique exercises, induced changes in pelvis and lower-limb kinematics at maximal speed and improved sprint performance.
METHODS


Healthy amateur athletes were assigned to a control or intervention group (IG). A sprint test with 3-dimensional kinematic measurements was performed before (PRE) and after (POST) 6 weeks of training. The IG program included 3 weekly sessions integrating coaching, strength and conditioning, and physical therapy approaches (eg, manual therapy, mobility, lumbopelvic control, strength and sprint ""front-side mechanics""-oriented drills).
RESULTS


Analyses of variance showed no between-group differences at PRE. At POST, intragroup analyses showed PRE-POST differences for the pelvic (sagittal and frontal planes) and thigh kinematics and improved sprint performance (split times) for the IG only. Specifically, IG showed (1) a lower anterior pelvic tilt during the late swing phase, (2) greater pelvic obliquity on the free-leg side during the early swing phase, (3) higher vertical position of the front-leg knee, (4) an increase in thigh angular velocity and thigh retraction velocity, (5) lower between-knees distance at initial contact, and (6) a shorter ground contact duration. The intergroup analysis revealed disparate effects (possibly to very likely) in the most relevant variables investigated.
CONCLUSION


The 6-week multimodal training program induced clear pelvic and lower-limb kinematic changes during maximal speed sprinting. These alterations may collectively be associated with reduced risk of muscle strain and were concomitant with significant sprint performance improvement.",2021,"At POST, intragroup analyses showed PRE-POST differences for the pelvic (sagittal and frontal planes) and thigh kinematics and improved sprint performance (split times) for the IG only.",['Healthy amateur athletes'],"['sessions integrating coaching, strength and conditioning, and physical therapy approaches (eg,\xa0manual therapy, mobility, lumbopelvic control, strength and sprint ""front-side mechanics""-oriented drills', 'multimodal training program']","['clear pelvic and lower-limb kinematic changes', 'PRE-POST differences for the pelvic (sagittal and frontal planes) and thigh kinematics and improved sprint performance', 'lower anterior pelvic tilt', 'pelvic obliquity', 'changes in pelvis and lower-limb kinematics at maximal speed and improved sprint performance', 'thigh angular velocity and thigh retraction velocity, (5)\xa0lower between-knees distance']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior'}, {'cui': 'C1629036', 'cui_str': 'Pelvic declination'}, {'cui': 'C0264192', 'cui_str': 'Pelvic obliquity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.0130959,"At POST, intragroup analyses showed PRE-POST differences for the pelvic (sagittal and frontal planes) and thigh kinematics and improved sprint performance (split times) for the IG only.","[{'ForeName': 'Jurdan', 'Initials': 'J', 'LastName': 'Mendiguchia', 'Affiliation': ''}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Castaño-Zambudio', 'Affiliation': ''}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Jiménez-Reyes', 'Affiliation': ''}, {'ForeName': 'Jean-Benoît', 'Initials': 'JB', 'LastName': 'Morin', 'Affiliation': ''}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Edouard', 'Affiliation': ''}, {'ForeName': 'Filipe', 'Initials': 'F', 'LastName': 'Conceição', 'Affiliation': ''}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Tawiah-Dodoo', 'Affiliation': ''}, {'ForeName': 'Steffi L', 'Initials': 'SL', 'LastName': 'Colyer', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2021-0107']
1310,34794388,"Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial.","BACKGROUND


As treatments for cancer have improved, more people are surviving cancer. However, compared to people without a history of cancer, cancer survivors are more likely to die of cardiovascular disease (CVD). Increased risk for CVD-related mortality among cancer survivors is partially due to lack of medication adherence and problems that exist in care coordination between cancer specialists, primary care physicians, and cardiologists.
METHODS/DESIGN


The Onco-primary care networking to support TEAM-based care (ONE TEAM) study is an 18-month cluster-randomized controlled trial with clustering at the primary care clinic level. ONE TEAM compares the provision of the iGuide intervention to patients and primary care providers versus an education-only control. For phase 1, at the patient level, the intervention includes video vignettes and a live webinar; provider-level interventions include electronic health records-based communication and case-based webinars. Participants will be enrolled from across North Carolina one of their first visits with a cancer specialist (e.g., surgeon, radiation or medical oncologist). We use a sequential multiple assignment randomized trial (SMART) design. Outcomes (measured at the patient level) will include Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of management of three CVD comorbidities using laboratory testing (glycated hemoglobin [A1c], lipid profile) and blood pressure measurements; (2) medication adherence assessed pharmacy refill data using Proportion of Days Covered (PDC); and (3) patient-provider communication (Patient-Centered Communication in Cancer Care, PCC-Ca-36). Primary care clinics in the intervention arm will be considered non-responders if 90% or more of their participating patients do not meet the modified HEDIS quality metrics at the 6-month measurement, assessed once the first enrollee from each practice reaches the 12-month mark. Non-responders will be re-randomized to either continue to receive the iGuide 1 intervention, or to receive the iGuide 2 intervention, which includes tailored videos for participants and specialist consults with primary care providers.
DISCUSSION


As the population of cancer survivors grows, ONE TEAM will contribute to closing the CVD outcomes gap among cancer survivors by optimizing and integrating cancer care and primary care teams. ONE TEAM is designed so that it will be possible for others to emulate and implement at scale.
TRIAL REGISTRATION


This study (NCT04258813) was registered in clinicaltrals.gov on February 6, 2020.",2021,"For phase 1, at the patient level, the intervention includes video vignettes and a live webinar; provider-level interventions include electronic health records-based communication and case-based webinars.","['cancer patients', 'Participants will be enrolled from across North Carolina one of their first visits with a cancer specialist (e.g., surgeon, radiation or medical oncologist']","['iGuide intervention', 'Low-touch, team-based care']","['Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of management of three CVD comorbidities using laboratory testing (glycated hemoglobin [A1c], lipid profile) and blood pressure measurements; (2) medication adherence assessed pharmacy refill data using Proportion of Days Covered (PDC); and (3) patient-provider communication (Patient-Centered Communication in Cancer Care, PCC-Ca-36']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C1555767', 'cui_str': 'Medical oncologist'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}]",,0.375045,"For phase 1, at the patient level, the intervention includes video vignettes and a live webinar; provider-level interventions include electronic health records-based communication and case-based webinars.","[{'ForeName': 'Leah L', 'Initials': 'LL', 'LastName': 'Zullig', 'Affiliation': 'Department of Population Health Sciences, Duke University School Of Medicine, 215 Morris St, Durham, NC, 27701, USA. leah.zullig@duke.edu.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Shahsahebi', 'Affiliation': 'Duke University Family Medicine and Community Health, 2424 Erwin Rd, Ste 601, DUMC, Box 2714, Durham, NC, 27705, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Neely', 'Affiliation': 'Duke Cancer Institute, Duke University, 2424 Erwin Rd, Durham, NC, 27701, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Hyslop', 'Affiliation': 'Department of Biostatistics, Duke University, 2424 Erwin Road, 9064 Hock Plaza, Durham, NC, 27705, USA.'}, {'ForeName': 'Renee A V', 'Initials': 'RAV', 'LastName': 'Avecilla', 'Affiliation': 'Center for Onco-Primary Care, Duke Cancer Institute, 2424 Erwin Road, Hock Plaza, Ste 601, Durham, NC, 27705, USA.'}, {'ForeName': 'Brittany M', 'Initials': 'BM', 'LastName': 'Griffin', 'Affiliation': 'Center for Onco-Primary Care, Duke Cancer Institute, 2424 Erwin Road, Hock Plaza, Ste 601, Durham, NC, 27705, USA.'}, {'ForeName': 'Kacey', 'Initials': 'K', 'LastName': 'Clayton-Stiglbauer', 'Affiliation': 'Center for Onco-Primary Care, Duke Cancer Institute, 2424 Erwin Road, Hock Plaza, Ste 601, Durham, NC, 27705, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Coles', 'Affiliation': 'Department of Population Health Sciences, Duke University School Of Medicine, 215 Morris St, Durham, NC, 27701, USA.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Owen', 'Affiliation': 'Duke Cancer Network, 20 Duke Medicine Circle, Durham, NC, 27710, USA.'}, {'ForeName': 'Bryce B', 'Initials': 'BB', 'LastName': 'Reeve', 'Affiliation': 'Department of Population Health Sciences, Duke University School Of Medicine, 215 Morris St, Durham, NC, 27701, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Shah', 'Affiliation': 'Duke Institute for Health Innovation, Duke University Health System, 200 Morris St, Durham, NC, 27701, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Shelby', 'Affiliation': 'Duke Psychiatry and Behavioral Sciences, Duke University School of Medicine, 2200 W. Main St, Ste 340, Durham, NC, 27705, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sutton', 'Affiliation': 'Duke Cancer Network, 20 Duke Medicine Circle, Durham, NC, 27710, USA.'}, {'ForeName': 'Michaela A', 'Initials': 'MA', 'LastName': 'Dinan', 'Affiliation': 'Department of Chronic Disease Epidemiology, Yale School of Public Health, 60 College Street, New Haven, CT, 06510, USA.'}, {'ForeName': 'S Yousuf', 'Initials': 'SY', 'LastName': 'Zafar', 'Affiliation': 'Duke University School of Medicine, 2200 W. Main St, Ste 340, Durham, NC, 27705, USA.'}, {'ForeName': 'Nishant P', 'Initials': 'NP', 'LastName': 'Shah', 'Affiliation': 'Duke Heart Center, Duke University School of Medicine, 2200 W. Main St, Ste 340, Durham, NC, 27705, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Dent', 'Affiliation': 'Duke Cancer Institute, Duke University, 2200 W. Main St, Ste 340, Durham, NC, 27705, USA.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Oeffinger', 'Affiliation': 'Duke Cancer Institute, Duke University School of Medicine, 2200 W. Main St, Ste 340, Durham, NC, 27705, USA.'}]",BMC family practice,['10.1186/s12875-021-01569-8']
1311,34795408,"Phase 1A/1B dose-escalation and -expansion study to evaluate the safety, pharmacokinetics, food effects and antitumor activity of pamiparib in advanced solid tumours.","BACKGROUND


Pamiparib, a PARP1/2 inhibitor, demonstrated antitumor activity in preclinical models.
METHODS


This Phase 1A/1B dose-escalation/dose-expansion study enrolled adults (≥18 years) with advanced/metastatic cancer. The dose-escalation phase evaluated the recommended Phase 2 dose (RP2D), maximum tolerated dose (MTD), and pharmacokinetics; the dose-expansion phase evaluated the antitumor activity and food effects.
RESULTS


Patients (N = 101) were enrolled in dose-escalation (n = 64) and dose-expansion (n = 37). During BID dose-escalation, dose-limiting toxicities were Grade 2 nausea (n = 1, 40 mg; n = 1, 80 mg); Grade 2 nausea and Grade 2 anorexia (n = 1, 120 mg), Grade 2 nausea, Grade 3 fatigue and Grade 3 paraesthesia (n = 1, 120 mg); MTD was 80 mg BID and RP2D was 60 mg BID. Common adverse events (AEs) were nausea (69.3%), fatigue (48.5%) and anaemia (35.6%); the most common Grade ≥3 AE was anaemia (24.8%). There was a dose-proportional increase in pamiparib exposure; no food effects on pharmacokinetics were observed. In the efficacy-evaluable population (n = 77), objective response rate (ORR) was 27.3% (95% CI, 17.7-38.6%). Median duration of response was 14.9 months (95% CI, 8.7-26.3). In the epithelial ovarian cancer (EOC)-evaluable population (n = 51), ORR was 41.2% (95% CI, 27.6-55.8%).
CONCLUSIONS


Pamiparib was tolerated with manageable AEs, and antitumor activity was observed in patients with EOC. CLINICALTRIALS.
GOV IDENTIFIER


NCT02361723.",2022,"Common adverse events (AEs) were nausea (69.3%), fatigue (48.5%) and anaemia (35.6%); the most common Grade ≥3 AE was anaemia (24.8%).","['enrolled adults (≥18 years) with advanced/metastatic cancer', 'Patients (N\u2009=\u2009101', 'patients with EOC', 'advanced solid tumours']",[],"['fatigue', 'tolerated with manageable AEs, and antitumor activity', 'ORR', 'anaemia', 'nausea', 'Grade 2 nausea and Grade 2 anorexia', 'objective response rate (ORR', 'Median duration of response', 'safety, pharmacokinetics, food effects and antitumor activity', 'Grade 2 nausea, Grade 3 fatigue and Grade 3 paraesthesia', 'antitumor activity and food effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]",[],"[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}]",,0.117467,"Common adverse events (AEs) were nausea (69.3%), fatigue (48.5%) and anaemia (35.6%); the most common Grade ≥3 AE was anaemia (24.8%).","[{'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Voskoboynik', 'Affiliation': 'Nucleus Network, Melbourne, VIC, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mileshkin', 'Affiliation': 'Peter MacCallum Cancer Centre-East Melbourne, East Melbourne, VIC, Australia.'}, {'ForeName': 'Hui K', 'Initials': 'HK', 'LastName': 'Gan', 'Affiliation': 'Olivia Newton-John Cancer Wellness and Research Centre, Austin Hospital, Heidelberg, Melbourne, VIC, Australia.'}, {'ForeName': 'Ganessan', 'Initials': 'G', 'LastName': 'Kichenadasse', 'Affiliation': 'Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Bedford Park, SA, Australia.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'BeiGene USA, Inc., San Mateo, CA, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'BeiGene USA, Inc., San Mateo, CA, USA.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'BeiGene USA, Inc., San Mateo, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Millward', 'Affiliation': 'Linear Clinical Research & University of Western Australia, Nedlands, WA, Australia. michael.millward@uwa.edu.au.'}]",British journal of cancer,['10.1038/s41416-021-01632-2']
1312,34806486,Prospective randomised trial of bolus vs. continuous regime of jejunostomy feed.,"Enteral alimentation can be administered continuously, cyclically, intermittently, or by a bolus technique. Current literature does not suggest superiority of any one regime. Most studies have used nasogastric feeds, little is known about the outcome of jejunal feeding.This study compares the efficiency and safety of bolus and continuous jejunostomy feeding. 46 adults undergoing a feeding jejunostomy for nutritional support or as an adjunct to a major upper GI surgery, were randomised to bolus feeding (BF group, n = 24) and continuous feeding (CF group, n = 22). Demographic, anthropometric, and laboratory parameters were measured preoperatively and on post-operative days (POD) 3, 7, 15, and 30. These parameters; as well as nutritional and functional outcomes, and complications at POD 30; were comparable in both groups. Both groups tolerated jejunal feeds well. Bolus feeding is simple, inexpensive, and permits daily physical activities. Hence it may be preferred over continuous jejunostomy feeding for enteral alimentation.",2022,"These parameters; as well as nutritional and functional outcomes, and complications at POD 30; were comparable in both groups.",['46 adults undergoing a feeding jejunostomy for nutritional support or as an adjunct to a major upper GI surgery'],"['bolus and continuous jejunostomy feeding', 'bolus feeding (BF group, n\u2009=\u200924) and continuous feeding (CF', 'bolus vs. continuous regime of jejunostomy feed']","['Demographic, anthropometric, and laboratory parameters', 'efficiency and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0192715', 'cui_str': 'Jejunostomy feeding'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0203057', 'cui_str': 'Upper gastrointestinal tract series'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0192715', 'cui_str': 'Jejunostomy feeding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022377', 'cui_str': 'Creation of jejunostomy'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",46.0,0.0140046,"These parameters; as well as nutritional and functional outcomes, and complications at POD 30; were comparable in both groups.","[{'ForeName': 'Vipin', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Department of Surgery, 29698NSCB Government Medical College Jabalpur (MP) India.'}, {'ForeName': 'Uday', 'Initials': 'U', 'LastName': 'Somashekar', 'Affiliation': 'Department of Surgery, 29698NSCB Government Medical College Jabalpur (MP) India.'}, {'ForeName': 'Dileep Singh', 'Initials': 'DS', 'LastName': 'Thakur', 'Affiliation': 'Department of Surgery, 29698NSCB Government Medical College Jabalpur (MP) India.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Kothari', 'Affiliation': 'Department of Surgery, 29698NSCB Government Medical College Jabalpur (MP) India.'}, {'ForeName': 'Dhananjaya', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Surgery, 29698NSCB Government Medical College Jabalpur (MP) India.'}]",Tropical doctor,['10.1177/00494755211058949']
1313,34808687,Detection of Fetal Anomalies by Remotely Directed and Interpreted Ultrasound (Teleultrasound): A Randomized Noninferiority Trial.,"OBJECTIVE


To determine the accuracy and reliability of remotely directed and interpreted ultrasound (teleultrasound) as compared with standard in-person ultrasound for the detection of fetal anomalies, and to determine participants' satisfaction with teleultrasound.
STUDY DESIGN


This was a single-center, randomized (1:1) noninferiority study. Individuals referred to the maternal-fetal medicine (MFM) ultrasound clinic were randomized to standard in-person ultrasound and counseling or teleultrasound and telemedicine counseling. The primary outcome was major fetal anomaly detection rate (sensitivity). All ultrasounds were performed by registered diagnostic medical sonographers and interpretations were done by a group of five MFM physicians. After teleultrasound was completed, the teleultrasound patients filled out a satisfaction survey using a Likert scale. Newborn data were obtained from the newborn record and statewide birth defect databases.
RESULTS


Of 300 individuals randomized in each group, 294 were analyzed in the remotely interpreted teleultrasound group and 291 were analyzed in the in-person ultrasound group. The sensitivity of sonographic detection of 28 anomalies was 82.14% in the control group and of 20 anomalies in the telemedicine group, it was 85.0%. The observed difference in sensitivity was 0.0286, much smaller than the proposed noninferiority limit of 0.05. Specificity, negative predictive value, positive predictive value, and accuracy were more than 94% for both groups. Patient satisfaction was more than 95% on all measures, and there were no significant differences in patient satisfaction based on maternal characteristics.
CONCLUSION


Teleultrasound is not inferior to standard in-person ultrasound for the detection of fetal anomalies. Teleultrasound was uniformly well received by patients, regardless of demographics. These key findings support the continued expansion of telemedicine services.
KEY POINTS


· For detection of major anomalies, teleultrasound is comparable to standard ultrasound.. · Teleultrasound was well accepted by patients.. · Teleultrasound use should be expanded..",2022,"The sensitivity of sonographic detection of 28 anomalies was 82.14% in the control group and of 20 anomalies in the telemedicine group, it was 85.0%.","['300 individuals randomized in each group, 294 were analyzed in the remotely interpreted teleultrasound group and 291 were analyzed in the in-person ultrasound group', 'Individuals referred to the maternal-fetal medicine (MFM) ultrasound clinic']","['Remotely Directed and Interpreted Ultrasound (Teleultrasound', 'standard in-person ultrasound and counseling or teleultrasound and telemedicine counseling', 'remotely directed and interpreted ultrasound (teleultrasound']","['major fetal anomaly detection rate (sensitivity', 'sensitivity', 'Specificity, negative predictive value, positive predictive value, and accuracy', 'patient satisfaction based on maternal characteristics', 'Patient satisfaction', 'sensitivity of sonographic detection of 28 anomalies']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1285553', 'cui_str': 'Interprets'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",300.0,0.0839046,"The sensitivity of sonographic detection of 28 anomalies was 82.14% in the control group and of 20 anomalies in the telemedicine group, it was 85.0%.","[{'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Whittington', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}, {'ForeName': 'Dawn S', 'Initials': 'DS', 'LastName': 'Hughes', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}, {'ForeName': 'Nader Z', 'Initials': 'NZ', 'LastName': 'Rabie', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}, {'ForeName': 'Songthip T', 'Initials': 'ST', 'LastName': 'Ounpraseuth', 'Affiliation': 'Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}, {'ForeName': 'Wendy N', 'Initials': 'WN', 'LastName': 'Nembhard', 'Affiliation': 'College of Public Health, Arkansas Center for Birth Defects Research and Prevention, Fay W. Boozman College of Public Health, University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': 'Department of Obstetrics and Gynecology, McGovern Medical School at UTHealth, Houston, Texas.'}, {'ForeName': 'Everett F', 'Initials': 'EF', 'LastName': 'Magann', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}]",American journal of perinatology,['10.1055/s-0041-1739352']
1314,34808620,Use of Remifentanil Associated with Lidocaine for Feticides in Late Terminations of Pregnancy: A Randomized Clinical Trial.,"INTRODUCTION


In France, performance of a termination of pregnancy is legally possible without any gestational age limit. After 22 weeks of gestation, a feticide is ethically performed using usually sufentanil and lidocaine. The aim of this study was to compare the use of remifentanil, a fast-acting morphine-derivating product, instead of sufentanil.
METHODS


This 2-center randomized, controlled, single-blinded phase-III treatment trial had 2 parallel arms: an experimental group using remifentanil with lidocaine versus a control group receiving sufentanil associated with lidocaine. This trial took place over a 40-month period. The primary outcome was time to fetal asystole after lidocaine injection. The secondary outcome measures were the procedure's success rate, the rate of serious maternal side effects, and the presence of cellular or tissue modifications.
RESULTS


The study included 66 women, randomized into 2 groups of similar size and characteristics. Time to fetal asystole did not differ significantly between the groups, with a delay of 4 min (Q1-Q3, 2-11) in the sufentanil group and 4 min (Q1-Q3, 1-10) in the remifentanil group (p = 0.84). Similarly, the success rate of the procedure did not differ significantly. Fetal asystole was procured in <2 min and persisted >1 min for 16 (25.8%) women in our total population: 7 (22.5%) in the sufentanil group and 9 (29.0%) in the remifentanil group, p = 0.77. No severe maternal side effects were observed. Among the 49 fetopathological examinations performed, the few tissue and cell modifications observed did not cause any interpretation difficulties in either group.
DISCUSSION/CONCLUSION


Use of remifentanil instead of sufentanil for feticide procedure did not improve time to fetal asystole. No harmful effect was observed for either maternal tolerance or interpretation of the histologic slides.",2021,"Among the 49 fetopathological examinations performed, the few tissue and cell modifications observed did not cause any interpretation difficulties in either group.
","['66 women, randomized into 2 groups of similar size and characteristics', 'Late Terminations of Pregnancy']","['sufentanil and lidocaine', 'Lidocaine', 'remifentanil with lidocaine', 'Remifentanil', 'sufentanil', 'lidocaine', 'remifentanil']","['time to fetal asystole', 'Time to fetal asystole', 'success rate of the procedure', 'Fetal asystole', ""procedure's success rate, the rate of serious maternal side effects, and the presence of cellular or tissue modifications"", 'severe maternal side effects']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0392535', 'cui_str': 'Termination of pregnancy'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",66.0,0.047355,"Among the 49 fetopathological examinations performed, the few tissue and cell modifications observed did not cause any interpretation difficulties in either group.
","[{'ForeName': 'Romy', 'Initials': 'R', 'LastName': 'Rayssiguier', 'Affiliation': 'Department of Obstetrics and Gynaecology, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Fuchs', 'Affiliation': 'Department of Obstetrics and Gynaecology, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Mousty', 'Affiliation': 'Department of Obstetrics and Gynaecology, CHU Nîmes, Nîmes, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Morau', 'Affiliation': 'Department of Anaesthesia Intensive Care and Perioperative Medicine, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Hlioua', 'Affiliation': 'Department of Anaesthesia Intensive Care and Perioperative Medicine, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Wells', 'Affiliation': 'Medical Genetics and Foetopathology, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Musizzano', 'Affiliation': 'Anatomy and Pathological Cytology, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Nagot', 'Affiliation': 'Medical Informations, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Graf', 'Affiliation': 'Department of Obstetrics and Gynaecology, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Legoux', 'Affiliation': 'Department of Anaesthesia Intensive Care and Perioperative Medicine, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boulot', 'Affiliation': 'Department of Obstetrics and Gynaecology, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Dumont', 'Affiliation': 'Department of Obstetrics and Gynaecology, CHU La Réunion Saint-Pierre, Saint-Pierre, France.'}]",Fetal diagnosis and therapy,['10.1159/000520448']
1315,34812692,The randomized trial of mammography screening that was not-A cautionary tale.,"Two randomized trials were conducted in Canada in the 1980s to test the efficacy of breast cancer screening. Neither of the trials demonstrated benefit. Concerns were raised regarding serious errors in trial design and conduct. Here we describe the conditions that could allow subversion of randomization to occur and the inclusion of many symptomatic women in a screening trial. We examine anomalies in data where the balance would be expected between trial arms. ""Open book"" randomization and performance of clinical breast examination on all women before allocation to a trial arm allowed women with palpable findings to be mis-randomized into the mammography arm. Multiple indicators raising suspicion of subversion are present including a large excess in poor-prognosis cancers in the mammography trial arm at prevalence screen. Personnel described shifting of women from the control group into the mammography group. There is compelling evidence of subversion of randomization in Canadian National Breast Screening Study. Mis-randomization of even a few women with advanced breast cancer could markedly affect measured screening efficacy. The Canadian National Breast Screening Study trials should not influence breast screening policies.",2022,Neither of the trials demonstrated benefit.,[],['mammography screening'],[],[],"[{'cui': 'C0203028', 'cui_str': 'Screening mammography'}]",[],,0.168878,Neither of the trials demonstrated benefit.,"[{'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Yaffe', 'Affiliation': 'Department of Medical Biophysics, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Seely', 'Affiliation': 'Department of Radiology, 12365University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Paula B', 'Initials': 'PB', 'LastName': 'Gordon', 'Affiliation': 'Department of Radiology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Shushiela', 'Initials': 'S', 'LastName': 'Appavoo', 'Affiliation': 'Department of Diagnostic Imaging, 12357University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kopans', 'Affiliation': 'Department of Radiology, 1811Harvard Medical School, Boston, MA, USA.'}]",Journal of medical screening,['10.1177/09691413211059461']
1316,34814222,PEEK versus Metallic Attachment-Retained Obturators for Patient Satisfaction: A Randomized Controlled Trial.,"OBJECTIVE


The aim of the study was patients' satisfaction evaluation and radiographic evaluation of the terminal abutments of attachment-retained maxillary obturators with metal framework versus milled polyetheretherketone (PEEK) framework in the management of maxillectomy cases.
MATERIALS AND METHODS


Eighteen participants were randomly divided into three parallel groups ( n  = 6). Participants of the PEEK group received attachment-retained obturators with milled PEEK framework, the metal group received an attachment-retained obturator with a metallic framework, and the conventional group received conventional clasp-retained obturators with a metallic framework (Control group). The evaluation included was radiographic evaluation and patients' satisfaction in this study included two scales-""The Obturator Functioning Scale"" and ""The European Organization for Research and Treatment of Cancer Head and Neck 35"" using one-way ANOVA test.
RESULTS


Both PEEK and metal groups showed a statistically significant lower mean bone loss ( p  <0.050) compared with the conventional group during all follow-up periods. There is no statistically significant difference between the PEEK and metal groups during all follow-up periods. Regarding patient satisfaction, both the PEEK and metal groups showed a statistically significant decrease score ( p  <0.050) compared with the conventional group in various aspects of patients' satisfaction scales as satisfaction with the look and difficulty of talking to the public, and noticeable clasps. In comparison, the PEEK group showed a statistically significant decrease score ( p  <0.050) than the metal group with respect to satisfaction with the look along all follow-up periods.
CONCLUSIONS


PEEK attachment-retained maxillary definitive obturators could be considered a promising treatment modality for patients with acquired maxillary defects with regard to esthetics and satisfaction.",2022,"Regarding patient satisfaction, both the PEEK and metal groups showed a statistically significant decrease score ( p  <0.050) compared with the conventional group in various aspects of patients' satisfaction scales as satisfaction with the look and difficulty of talking to the public, and noticeable clasps.","['Eighteen participants', 'Patient Satisfaction', 'patients with acquired maxillary defects with regard to esthetics and satisfaction']","['attachment-retained obturators with milled PEEK framework, the metal group received an attachment-retained obturator with a metallic framework, and the conventional group received conventional clasp-retained obturators with a metallic framework (Control group', 'metal framework versus milled polyetheretherketone (PEEK) framework']",['mean bone loss'],"[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0182021', 'cui_str': 'Obturator'}, {'cui': 'C0599997', 'cui_str': 'Mill'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450152', 'cui_str': 'Metal framework'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",18.0,0.0332314,"Regarding patient satisfaction, both the PEEK and metal groups showed a statistically significant decrease score ( p  <0.050) compared with the conventional group in various aspects of patients' satisfaction scales as satisfaction with the look and difficulty of talking to the public, and noticeable clasps.","[{'ForeName': 'Mohamed Yahia', 'Initials': 'MY', 'LastName': 'Sharaf', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, University of Menoufia, Menoufia, Egypt.'}, {'ForeName': 'Asharaf Email', 'Initials': 'AE', 'LastName': 'Eskander', 'Affiliation': 'Department of Prosthodontics, Faculty of Oral and Dental Medicine, University of Cairo, Cairo, Egypt.'}]",European journal of dentistry,['10.1055/s-0041-1731839']
1317,34816273,"Hypocaloric diet with lower meal frequency did not affect weight loss, body composition and insulin responsiveness, but improved lipid profile: a randomized clinical trial.","Dietary approaches are essential to control obesity, but the effectiveness of changes in meal frequency (MF) as a strategy for body weight loss or maintenance remain unclear. This study aimed to evaluate the influence of MF of a hypocaloric diet on weight loss, body composition, active ghrelin levels and metabolic indicators of obese women. This is a randomized, parallel clinical trial, including 40 women divided into two groups that received a hypocaloric diet with different MFs: MF6: six meals per day, and MF3: three meals per day. Dietary, laboratory, anthropometric and body composition indicators were assessed, as well as energy expenditure (EE), before and after the 90 days of the intervention. Dietary consumption did not differ between groups, before or after intervention. The two groups reduced their energy intake after intervention, but there were no differences between the groups. Waist circumference (WC) was reduced and resting metabolic rate had increased in the MF3 group at the end compared to baseline. Moreover, there was a significant difference in the triglyceride levels between groups after intervention, with an important reduction in the MF3 group, although changes in body composition, blood glucose, plasma ghrelin levels and EE variables did not differ between the groups at the end. It is concluded that, the hypocaloric diet with different MF each day did not change weight loss, body composition or insulin responsiveness, but there was an improvement of triglyceridemia in the MF3 group. The present study suggests that eating snacks between meals is not an important factor for weight loss and improvement of metabolic health in women with obesity.",2021,Waist circumference (WC) was reduced and resting metabolic rate had increased in the MF3 group at the end compared to baseline.,"['obese women', 'women with obesity', '40 women divided into two groups that received a']","['hypocaloric diet', 'hypocaloric diet with different MFs', 'Hypocaloric diet']","['resting metabolic rate', 'triglyceride levels', 'weight loss, body composition and insulin responsiveness', 'Waist circumference (WC', 'body composition, blood glucose, plasma ghrelin levels and EE variables', 'energy expenditure (EE', 'energy intake', 'weight loss, body composition or insulin responsiveness', 'lipid profile', 'Dietary consumption', 'Dietary, laboratory, anthropometric and body composition indicators', 'weight loss, body composition, active ghrelin levels and metabolic indicators']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205177', 'cui_str': 'Active'}]",,0.0136898,Waist circumference (WC) was reduced and resting metabolic rate had increased in the MF3 group at the end compared to baseline.,"[{'ForeName': 'Érika Duarte', 'Initials': 'ÉD', 'LastName': 'Grangeiro', 'Affiliation': 'Department of Nutrition and Dietetics, Nutrition Institute Josué de Castro, Federal University of Rio de Janeiro, Brazil. erikawduartegs@gmail.com.'}, {'ForeName': 'Mariana Silva', 'Initials': 'MS', 'LastName': 'Trigueiro', 'Affiliation': 'Department of Nutrition and Dietetics, Nutrition Institute Josué de Castro, Federal University of Rio de Janeiro, Brazil. erikawduartegs@gmail.com.'}, {'ForeName': 'Leysimar de Oliveira', 'Initials': 'LO', 'LastName': 'Siais', 'Affiliation': 'Department of Nutrition and Dietetics, Nutrition Institute Josué de Castro, Federal University of Rio de Janeiro, Brazil. erikawduartegs@gmail.com.'}, {'ForeName': 'Hilana Moreira', 'Initials': 'HM', 'LastName': 'Paiva', 'Affiliation': 'Department of Nutrition and Dietetics, Nutrition Institute Josué de Castro, Federal University of Rio de Janeiro, Brazil. erikawduartegs@gmail.com.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Sola-Penna', 'Affiliation': 'Laboratório de Enzimologia e Controle do Metabolismo (LabECoM), Departamento de Biotecnologia Farmacêutica, Faculdade de Farmácia, Rio de Janeiro, Brazil.'}, {'ForeName': 'Marcelo Ribeiro', 'Initials': 'MR', 'LastName': 'Alves', 'Affiliation': 'HIV/AIDS Clinical Research Center, Evandro Chagas National Institute of Infectology, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Eliane Lopes', 'Initials': 'EL', 'LastName': 'Rosado', 'Affiliation': 'Department of Nutrition and Dietetics, Nutrition Institute Josué de Castro, Federal University of Rio de Janeiro, Brazil. erikawduartegs@gmail.com.'}]",Food & function,['10.1039/d1fo00484k']
1318,34817542,Economic Outcomes of Rehabilitation Therapy in Older Patients With Acute Heart Failure in the REHAB-HF Trial: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


In the Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial, a novel 12-week rehabilitation intervention demonstrated significant improvements in validated measures of physical function, quality of life, and depression, but no significant reductions in rehospitalizations or mortality compared with a control condition during the 6-month follow up. The economic implications of these results are important given the increasing pressures for cost containment in health care.
Objective


To report the economic outcomes of the REHAB-HF trial and estimate the potential cost-effectiveness of the intervention.
Design, Setting, Participants


The multicenter REHAB-HF trial randomized 349 patients 60 years or older who were hospitalized for acute decompensated heart failure to rehabilitation intervention or a control group; patients were enrolled from September 17, 2014, through September 19, 2019. For this preplanned secondary analysis of the economic outcomes, data on medical resource use and quality of life (via the 5-level EuroQol 5-Dimension scores converted to health utilities) were collected. Medical resource use and medication costs were estimated using 2019 US Medicare payments and the Federal Supply Schedule, respectively. Cost-effectiveness was estimated using the validated Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model, which uses an individual-patient simulation model informed by the prospectively collected trial data. Data were analyzed from March 24, 2019, to December 1, 2020.
Interventions


Rehabilitation intervention or control.
Main Outcomes and Measures


Costs, quality-adjusted life-years (QALYs), and the lifetime estimated cost per QALY gained (incremental cost-effectiveness ratio).
Results


Among the 349 patients included in the analysis (183 women [52.4%]; mean [SD] age, 72.7 [8.1] years; 176 non-White [50.4%] and 173 White [49.6%]), mean (SD) cumulative costs per patient were $26 421 ($38 955) in the intervention group (excluding intervention costs) and $27 650 ($30 712) in the control group (difference, -$1229; 95% CI, -$8159 to $6394; P = .80). The mean (SD) cost of the intervention was $4204 ($2059). Quality of life gains were significantly greater in the intervention vs control group during 6 months (mean utility difference, 0.074; P = .001) and sustained beyond the 12-week intervention. Incremental cost-effectiveness ratios were estimated at $58 409 and $35 600 per QALY gained for the full cohort and in patients with preserved ejection fraction, respectively.
Conclusions and Relevance


These analyses suggest that longer-term benefits of this novel rehabilitation intervention, particularly in the subgroup of patients with preserved ejection fraction, may yield good value to the health care system. However, long-term cost-effectiveness is currently uncertain and dependent on the assumption that benefits are sustained beyond study follow-up, which needs to be corroborated in future trials in this patient population.",2022,"Incremental cost-effectiveness ratios were estimated at $58 409 and $35 600 per QALY gained for the full cohort and in patients with preserved ejection fraction, respectively.
","['Older Patients With Acute Heart Failure in the REHAB-HF Trial', '349 patients included in the analysis (183 women [52.4%]; mean [SD] age, 72.7 [8.1] years; 176 non-White [50.4%] and 173 White [49.6', '349 patients 60 years or older who were hospitalized for acute decompensated heart failure to rehabilitation intervention or a control group; patients were enrolled from September 17, 2014, through September 19, 2019', 'Older Acute Heart Failure Patients (REHAB-HF) trial']","['Rehabilitation Therapy', 'Interventions\n\n\nRehabilitation intervention or control']","['Measures\n\n\nCosts, quality-adjusted life-years (QALYs), and the lifetime estimated cost per QALY gained (incremental cost-effectiveness ratio', 'Incremental cost-effectiveness ratios', 'rehospitalizations or mortality', 'medical resource use and quality of life (via the 5-level EuroQol 5-Dimension scores converted to health utilities', 'mean (SD) cumulative costs per patient', 'mean (SD) cost', 'Cost-effectiveness', 'physical function, quality of life, and depression', 'Quality of life gains']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",349.0,0.0570809,"Incremental cost-effectiveness ratios were estimated at $58 409 and $35 600 per QALY gained for the full cohort and in patients with preserved ejection fraction, respectively.
","[{'ForeName': 'Derek S', 'Initials': 'DS', 'LastName': 'Chew', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Zeitouni', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Whellan', 'Affiliation': 'Department of Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Dalane', 'Initials': 'D', 'LastName': 'Kitzman', 'Affiliation': 'Department of Internal Medicine, Sections on Cardiovascular Medicine and Geriatrics, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Duncan', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Pastva', 'Affiliation': 'Doctor of Physical Therapy Division, Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Gordon R', 'Initials': 'GR', 'LastName': 'Reeves', 'Affiliation': 'Novant Health Heart and Vascular Institute, Charlotte, North Carolina.'}, {'ForeName': 'M Benjamin', 'Initials': 'MB', 'LastName': 'Nelson', 'Affiliation': 'Department of Internal Medicine, Section on Cardiovascular Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Shelby D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}]",JAMA cardiology,['10.1001/jamacardio.2021.4836']
1319,32651467,"Proof-of-principle Phase I results of combining nivolumab with brachytherapy and external beam radiation therapy for Grade Group 5 prostate cancer: safety, feasibility, and exploratory analysis.","BACKGROUND


To determine whether combining brachytherapy with immunotherapy is safe in prostate cancer (PCa) and provides synergistic effects, we performed a Phase I/II trial on the feasibility, safety, and benefit of concurrent delivery of anti-PD-1 (nivolumab) with high-dose-rate (HDR) brachytherapy and androgen deprivation therapy (ADT) in patients with Grade Group 5 (GG5) PCa.
METHODS


Eligible patients were aged 18 years or older with diagnosis of GG5 PCa. Patients received ADT, nivolumab every two weeks for four cycles, with two cycles prior to first HDR, and two more cycles prior to second HDR, followed by external beam radiotherapy. The primary endpoint was to determine safety and feasibility. This Phase I/II trial is registered with ClinicalTrials.gov (NCT03543189).
RESULTS


Between September 2018 and June 2019, six patients were enrolled for the Phase I safety lead-in with a minimum observation period of 3 months after nivolumab administration. Overall, nivolumab was well tolerated in combination with ADT and HDR treatment. One patient experienced a grade 3 dose-limiting toxicity (elevated Alanine aminotransferase and Aspartate aminotransferase) after the second cycle of nivolumab. Three patients (50%) demonstrated early response with no residual tumor detected in ≥4 of 6 cores on biopsy post-nivolumab (4 cycles) and 1-month post-HDR. Increase in CD8+ and FOXP3+/CD4+ T cells in tissues, and CD4+ effector T cells in peripheral blood were observed in early responders.
CONCLUSION


Combination of nivolumab with ADT and HDR is well tolerated and associated with evidence of increased immune infiltration and antitumor activity.",2021,One patient experienced a grade 3 dose-limiting toxicity (elevated Alanine aminotransferase and Aspartate aminotransferase) after the second cycle of nivolumab.,"['Grade Group 5 prostate cancer', 'Eligible patients were aged 18 years or older with diagnosis of GG5 PCa', 'prostate cancer (PCa', 'patients with Grade Group 5 (GG5) PCa', 'Between September 2018 and June 2019']","['brachytherapy with immunotherapy', 'anti-PD-1 (nivolumab) with high-dose-rate (HDR) brachytherapy and androgen deprivation therapy (ADT', 'nivolumab with brachytherapy and external beam radiation therapy']","['Increase in CD8+ and FOXP3+/CD4+ T cells\xa0in tissues, and CD4+ effector T cells in peripheral blood', 'grade 3 dose-limiting toxicity (elevated Alanine aminotransferase and Aspartate aminotransferase', 'safety and feasibility']","[{'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",6.0,0.0528915,One patient experienced a grade 3 dose-limiting toxicity (elevated Alanine aminotransferase and Aspartate aminotransferase) after the second cycle of nivolumab.,"[{'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Departments of Radiation Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fernandez', 'Affiliation': 'Departments of Radiation Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Jasreman', 'Initials': 'J', 'LastName': 'Dhillon', 'Affiliation': 'Anatomic Pathology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Julieta', 'Initials': 'J', 'LastName': 'Abraham-Miranda', 'Affiliation': 'Cancer Epidemiology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Shivanshu', 'Initials': 'S', 'LastName': 'Awasthi', 'Affiliation': 'Cancer Epidemiology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Youngchul', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Jingsong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Genitourinary Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Genitourinary Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Serna', 'Affiliation': 'Cancer Epidemiology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Julio M', 'Initials': 'JM', 'LastName': 'Pow-Sang', 'Affiliation': 'Genitourinary Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Poch', 'Affiliation': 'Genitourinary Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Genitourinary Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Manley', 'Affiliation': 'Genitourinary Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Fink', 'Affiliation': 'Cancer Epidemiology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Naghavi', 'Affiliation': 'Departments of Radiation Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Javier F', 'Initials': 'JF', 'LastName': 'Torres-Roca', 'Affiliation': 'Departments of Radiation Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'G Daniel', 'Initials': 'GD', 'LastName': 'Grass', 'Affiliation': 'Departments of Radiation Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Sungjune', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Departments of Radiation Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Kujtim', 'Initials': 'K', 'LastName': 'Latifi', 'Affiliation': 'Departments of Radiation Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Hunt', 'Affiliation': 'Departments of Radiation Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Peter A S', 'Initials': 'PAS', 'LastName': 'Johnstone', 'Affiliation': 'Departments of Radiation Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.'}, {'ForeName': 'Kosj', 'Initials': 'K', 'LastName': 'Yamoah', 'Affiliation': 'Departments of Radiation Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA. Kosj.Yamoah@moffitt.org.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0254-y']
1320,34818596,Peri-implant parameters and cytokine profile among Peri-implant disease patients treated with Er Cr YSGG laser and PDT.,"AIM


To assess the effect of Er,Cr:YSGG (ECL) laser-assisted non-surgical treatment and Photodynamic therapy (PDT) as an adjunct to mechanical debridement (MD) on clinical and radiographic peri‑implant inflammatory parameters in patients with peri‑implant disease MATERIAL AND METHODS: A total of 95 patients with the peri‑implant disease were divided into 3 groups. Patients in group 1 were treated with MD only, patients in group 2 recieved MD+ECL and patients in group 3 were treated with MD+PDT. Perimplant parameters CBL: Crestal bone loss; PD: Probing depth; BI: Bleeding index; PI: Plaque index were measured from baseline to 3 month and 6 months follow up. The means and standard deviation (SD) of the aforementioned parameters were calculated using multiple comparison tests Post hoc Tukey test. Power analysis and sample size (PASS) was used for calculating sample size. The power was estimated at 85% along with a minimum of 30 participants in each group with a two-sided significance level of 0.05 was to be achieved RESULTS: At baseline mean scores of peri‑implant PI, BI and PD were comparable among patients in group 1 (control), 2 (ECL), and 3 (PDT). At 3 months follow up, mean scores of peri‑implant PI (P <0.05), BI (P <0.05) and PD (P <0.05) in group 1 (control) were significantly higher compared to group 2 (ECL) and 3 (PDT). At 6 months follow-up, PI and BI mean scores among groups 1, 2, and 3 were comparable (P>0.05). However, PD was significantly higher in control than groups 2 and 3 (P<0.05) CONCLUSION: MD with adjunct ECL and adjunct PDT are more efficient in reducing peri‑implant soft tissue inflammatory parameters for short-term use than MD alone.",2022,"At baseline mean scores of peri-implant PI, BI and PD were comparable among patients in group 1 (control), 2 (ECL), and 3 (PDT).","['patients with peri-implant disease', '95 patients with the peri-implant disease', 'Peri-implant disease patients treated with']","['MD', 'Er,Cr:YSGG (ECL) laser-assisted non-surgical treatment and Photodynamic therapy (PDT', 'MD+PDT', 'MD+ECL', 'mechanical debridement (MD', 'Er Cr YSGG laser and PDT']","['PD', 'peri-implant PI, BI and PD', 'PI and BI mean scores', 'Plaque index', 'mean scores of peri-implant PI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]",95.0,0.0186377,"At baseline mean scores of peri-implant PI, BI and PD were comparable among patients in group 1 (control), 2 (ECL), and 3 (PDT).","[{'ForeName': 'Montaser N', 'Initials': 'MN', 'LastName': 'Alqutub', 'Affiliation': 'Department of Periodontics and Community Dentistry, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia. Electronic address: alqutub@hotmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102641']
1321,34824098,"Deep Learning Enables 60% Accelerated Volumetric Brain MRI While Preserving Quantitative Performance: A Prospective, Multicenter, Multireader Trial.","BACKGROUND AND PURPOSE


In this prospective, multicenter, multireader study, we evaluated the impact on both image quality and quantitative image-analysis consistency of 60% accelerated volumetric MR imaging sequences processed with a commercially available, vendor-agnostic, DICOM-based, deep learning tool (SubtleMR) compared with that of standard of care.
MATERIALS AND METHODS


Forty subjects underwent brain MR imaging examinations on 6 scanners from 5 institutions. Standard of care and accelerated datasets were acquired for each subject, and the accelerated scans were enhanced with deep learning processing. Standard of care, accelerated scans, and accelerated-deep learning were subjected to NeuroQuant quantitative analysis and classified by a neuroradiologist into clinical disease categories. Concordance of standard of care and accelerated-deep learning biomarker measurements were assessed. Randomized, side-by-side, multiplanar datasets (360 series) were presented blinded to 2 neuroradiologists and rated for apparent SNR, image sharpness, artifacts, anatomic/lesion conspicuity, image contrast, and gray-white differentiation to evaluate image quality.
RESULTS


Accelerated-deep learning was statistically superior to standard of care for perceived quality across imaging features despite a 60% sequence scan-time reduction. Both accelerated-deep learning and standard of care were superior to accelerated scans for all features. There was no difference in quantitative volumetric biomarkers or clinical classification for standard of care and accelerated-deep learning datasets.
CONCLUSIONS


Deep learning reconstruction allows 60% sequence scan-time reduction while maintaining high volumetric quantification accuracy, consistent clinical classification, and what radiologists perceive as superior image quality compared with standard of care. This trial supports the reliability, efficiency, and utility of deep learning-based enhancement for quantitative imaging. Shorter scan times may heighten the use of volumetric quantitative MR imaging in routine clinical settings.",2021,"RESULTS


Accelerated-deep learning was statistically superior to standard of care for perceived quality across imaging features despite a 60% sequence scan-time reduction.",['Forty subjects underwent brain MR imaging examinations on 6 scanners from 5 institutions'],['volumetric quantitative MR imaging'],"['quantitative volumetric biomarkers', 'Volumetric Brain MRI']","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4028269', 'cui_str': 'Nuclear magnetic resonance imaging brain'}]",40.0,0.0640077,"RESULTS


Accelerated-deep learning was statistically superior to standard of care for perceived quality across imaging features despite a 60% sequence scan-time reduction.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bash', 'Affiliation': 'From the RadNet Inc (S.B., L.N.T.), Los Angeles, California suzie.bash@radnet.com.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Subtle Medical (L.W., E.G., A.S.), Menlo Park, California.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Airriess', 'Affiliation': 'Cortechs.ai. (C.A.), San Diego, California.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Zaharchuk', 'Affiliation': 'Stanford University Medical Center (G.Z.), Stanford, California.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gong', 'Affiliation': 'Subtle Medical (L.W., E.G., A.S.), Menlo Park, California.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shankaranarayanan', 'Affiliation': 'Subtle Medical (L.W., E.G., A.S.), Menlo Park, California.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Tanenbaum', 'Affiliation': 'From the RadNet Inc (S.B., L.N.T.), Los Angeles, California.'}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A7358']
1322,34826125,"Coenzyme Q10 in the Treatment of Heart Failure with Preserved Ejection Fraction: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND


Heart failure with preserved ejection fraction (HFpEF) is common in elderly people and is increasing in prevalence. No specific treatment for this condition exists. Coenzyme Q10 (CoQ10) is an essential cofactor for energy production, with reduced levels being noted in HF. Previous studies have suggested a possible role for CoQ10 in the treatment of HF. This study examined the effect of CoQ10 supplementation on diastolic function in HFpEF patients.
METHODS


We conducted a prospective, randomized, double-blind, placebo-controlled trial including patients aged > 55 years presenting with New York Heart Association class II-IV heart failure symptoms and left ventricular ejection fraction > 50%, with impaired diastolic function. Echocardiography and levels of serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) were performed at baseline and following 4 months of CoQ10 or placebo supplementation.
RESULTS


A total of 39 patients were enrolled-19 in the CoQ10 group and 20 in the placebo group. Baseline clinical characteristics were similar between groups, while compliance was high and also similar between the CoQ10 and placebo groups. There was no significant effect of treatment on indices of diastolic function (difference in the lateral E/e' ratio: -0.86 ± 6.57 in the CoQ10 group, +0.18 ± 3.76 in the placebo group; p = 0.561) or on serum NT-proBNP levels (- 72 pg/mL vs. - 42 pg/mL; p = 0.195).
CONCLUSIONS


In this pilot trial in elderly patients with HFpEF, treatment with CoQ10 did not significantly affect echocardiographic indices of diastolic function and serum NT-proBNP levels.
TRIAL REGISTRATION


This trial was registered in the US National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT02779634).",2022,"Baseline clinical characteristics were similar between groups, while compliance was high and also similar between the CoQ10 and placebo groups.","['39 patients were enrolled-19 in the CoQ10 group and 20 in the placebo group', 'elderly patients with HFpEF, treatment with', 'Heart Failure with Preserved Ejection Fraction', 'elderly people', 'HFpEF patients', 'patients aged >\xa055 years presenting with New York Heart Association class II-IV heart failure symptoms and left ventricular ejection fraction >\xa050%, with impaired diastolic function']","['Placebo', 'Coenzyme Q10', 'CoQ10 or placebo supplementation', 'CoQ10', 'CoQ10 supplementation', 'placebo', 'Coenzyme Q10 (CoQ10']","['Echocardiography and levels of serum N-terminal pro-B-type natriuretic peptide (NT-proBNP', 'indices of diastolic function', 'diastolic function', 'serum NT-proBNP levels', 'echocardiographic indices of diastolic function and serum NT-proBNP levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",39.0,0.436692,"Baseline clinical characteristics were similar between groups, while compliance was high and also similar between the CoQ10 and placebo groups.","[{'ForeName': 'Tal Y', 'Initials': 'TY', 'LastName': 'Samuel', 'Affiliation': 'Jesselson Integrated Heart Center, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Hasin', 'Affiliation': 'Jesselson Integrated Heart Center, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Gotsman', 'Affiliation': 'Department of Cardiology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Weitzman', 'Affiliation': 'Jesselson Integrated Heart Center, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Ben Ivgi', 'Affiliation': 'Department of Cardiology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Dadon', 'Affiliation': 'Jesselson Integrated Heart Center, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Asher', 'Affiliation': 'Jesselson Integrated Heart Center, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Offer', 'Initials': 'O', 'LastName': 'Amir', 'Affiliation': 'Department of Cardiology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Glikson', 'Affiliation': 'Jesselson Integrated Heart Center, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Ronny', 'Initials': 'R', 'LastName': 'Alcalai', 'Affiliation': 'Department of Cardiology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leibowitz', 'Affiliation': 'Department of Cardiology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. oleibo@hadassah.org.il.'}]",Drugs in R&D,['10.1007/s40268-021-00372-1']
1323,34835098,"Mathematical Modeling of Within-Host, Untreated, Cytomegalovirus Infection Dynamics after Allogeneic Transplantation.","Cytomegalovirus (CMV) causes significant morbidity and mortality in recipients of allogeneic hematopoietic cell transplantation (HCT). Whereas insights gained from mathematical modeling of other chronic viral infections such as HIV, hepatitis C, and herpes simplex virus-2 have aided in optimizing therapy, previous CMV modeling has been hindered by a lack of comprehensive quantitative PCR viral load data from untreated episodes of viremia in HCT recipients. We performed quantitative CMV DNA PCR on stored, frozen serum samples from the placebo group of participants in a historic randomized controlled trial of ganciclovir for the early treatment of CMV infection in bone marrow transplant recipients. We developed four main ordinary differential Equation mathematical models and used model selection theory to choose between 38 competing versions of these models. Models were fit using a population, nonlinear, mixed-effects approach. We found that CMV kinetics from untreated HCT recipients are highly variable. The models that recapitulated the observed patterns most parsimoniously included explicit, dynamic immune cell compartments and did not include dynamic target cell compartments, consistent with the large number of tissue and cell types that CMV infects. In addition, in our best-fitting models, viral clearance was extremely slow, suggesting severe impairment of the immune response after HCT. Parameters from our best model correlated well with participants' clinical risk factors and outcomes from the trial, further validating our model. Our models suggest that CMV dynamics in HCT recipients are determined by host immune response rather than target cell limitation in the absence of antiviral treatment.",2021,We developed four main ordinary differential Equation mathematical models and used model selection theory to choose between 38 competing versions of these models.,"['bone marrow transplant recipients', 'recipients of allogeneic hematopoietic cell transplantation (HCT']","['ganciclovir', 'placebo', 'Cytomegalovirus (CMV', 'quantitative CMV DNA PCR']",['CMV kinetics'],"[{'cui': 'C4545296', 'cui_str': 'Bone marrow transplant present'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0017066', 'cui_str': 'Ganciclovir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0369083', 'cui_str': 'Cytomegalovirus DNA'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}]","[{'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",,0.104002,We developed four main ordinary differential Equation mathematical models and used model selection theory to choose between 38 competing versions of these models.,"[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Duke', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, WA 98109, USA.'}, {'ForeName': 'Florencia A T', 'Initials': 'FAT', 'LastName': 'Boshier', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, WA 98109, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boeckh', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, WA 98109, USA.'}, {'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Schiffer', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, WA 98109, USA.'}, {'ForeName': 'E Fabian', 'Initials': 'EF', 'LastName': 'Cardozo-Ojeda', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, WA 98109, USA.'}]",Viruses,['10.3390/v13112292']
1324,34839016,A randomised phase II study of osimertinib and bevacizumab versus osimertinib alone as second-line targeted treatment in advanced NSCLC with confirmed EGFR and acquired T790M mutations: the European Thoracic Oncology Platform (ETOP 10-16) BOOSTER trial.,"BACKGROUND


While osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) is the standard treatment in patients with advanced non-small-cell lung cancer (NSCLC) with sensitising EGFR and acquired T790M mutations, progression inevitably occurs. The angiogenic pathway is implicated in EGFR TKI resistance.
PATIENTS AND METHODS


BOOSTER is an open-label randomised phase II trial investigating the efficacy and safety of combined osimertinib 80 mg daily and bevacizumab 15 mg/kg every 3 weeks, versus osimertinib alone, in patients with EGFR-mutant advanced NSCLC and acquired T790M mutations after failure on previous EGFR TKI therapy. Primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints were overall survival (OS), objective response rate (ORR) and adverse events (AEs).
RESULTS


Between May 2017 and February 2019, 155 patients were randomised (combination: 78; osimertinib: 77). At data cut-off of 22 February 2021, median follow-up was 33.8 months [interquartile range (IQR): 26.5-37.6 months] and 129 (83.2%) PFS events were reported in the intention-to-treat population. There was no difference in median PFS between the combination [15.4 months; 95% confidence interval (CI) 9.2-18.0 months] and osimertinib arm (12.3 months; 95% CI 6.2-17.2 months; stratified log-rank P = 0.83), [hazard ratio (HR) = 0.96; 95% CI 0.68-1.37]. Median OS was 24.0 months (95% CI 17.8-32.1 months) in the combination arm and 24.3 months (95% CI 16.9-37.0 months) in the osimertinib arm (stratified log-rank P = 0.91), (HR = 1.03; 95% CI 0.67-1.56). Exploratory analysis revealed a significant interaction of smoking history with treatment for PFS (adjusted P = 0.0052) with a HR of 0.52 (95% CI 0.30-0.90) for smokers, and 1.47 (95% CI 0.92-2.33) for never smokers. ORR was 55% in both arms and the median time to treatment failure was significantly shorter in the combination than in the osimertinib arm, 8.2 months versus 10.8 months, respectively (P = 0.0074). Safety of osimertinib and bevacizumab was consistent with previous reports with grade ≥3 treatment-related AEs (TRAEs) reported in 47% and 18% of patients on combination and osimertinib alone, respectively.
CONCLUSIONS


No difference in PFS was observed between osimertinib plus bevacizumab and osimertinib alone. Grade ≥3 TRAEs were more common in patients on combination.",2022,"ORR was 55% in both arms and the median time to treatment failure was significantly shorter in the combination than in the osimertinib arm, 8.2m vs 10.8m, respectively (p=0.0074).","['155 patients', 'advanced NSCLC with confirmed EGFR and acquired T790M mutations', 'patients with advanced non-small cell lung cancer (NSCLC) with sensitising EGFR and acquired T790M mutations, progression inevitably occurs', 'patients with EGFR-mutant advanced NSCLC and acquired T790M mutations after failure on previous EGFR TKI therapy']","['bevacizumab', 'osimertinib and bevacizumab', 'combined osimertinib 80 mg daily and bevacizumab']","['overall survival (OS), objective response rate (ORR), and adverse events (AEs', 'PFS', 'Grade ≥3 TRAEs', 'PFS events', 'ORR', 'median time to treatment failure', 'median PFS', 'progression-free survival (PFS', 'efficacy and safety', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4058829', 'cui_str': 'osimertinib 80 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",155.0,0.475869,"ORR was 55% in both arms and the median time to treatment failure was significantly shorter in the combination than in the osimertinib arm, 8.2m vs 10.8m, respectively (p=0.0074).","[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Soo', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, Singapore, Singapore.'}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'National Cancer Center, Center for Lung Cancer, Goyang, Republic of Korea.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Dafni', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece; Frontier Science Foundation Hellas, Athens, Greece.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Division of Medical Oncology, Seoul, Republic of Korea.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Yeo', 'Affiliation': 'Medical Oncology Department, Tan Tock Seng Hospital, Singapore, Singapore.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nadal', 'Affiliation': ""Medical Oncology Department, ICO L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Carcereny', 'Affiliation': ""Medical Oncology Department, Institut Català d'Oncologia Badalona Hospital Germans Trias i Pujol, B-ARGO Group, Badalona, Spain.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'de Castro', 'Affiliation': 'Medical Oncology Department, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Sala', 'Affiliation': 'Medical Oncology Department, Hospital Universitario Basurto, Bilbao, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bernabé', 'Affiliation': 'Medical Oncology Department, Hospital Virgen del Rocio, Sevilla, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Coate', 'Affiliation': 'Mid-Western Cancer Centre and University Hospital Limerick, Limerick, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Provencio Pulla', 'Affiliation': 'Hospital Puerta de Hierro, Majadahonda Medical Oncology Service, Madrid, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Garcia Campelo', 'Affiliation': 'Medical Oncology Department, Hospital Teresa Herrera, La Coruña, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cuffe', 'Affiliation': ""Department of Medical Oncology, St. James's Hospital, Dublin, Ireland.""}, {'ForeName': 'S M S', 'Initials': 'SMS', 'LastName': 'Hashemi', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam UMC, VU University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Früh', 'Affiliation': 'Cantonal Hospital St. Gallen, Oncology and Hematology, St. Gallen, Switzerland; Department of Oncology, Inselspital Bern, Bern, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Massuti', 'Affiliation': 'Medical Oncology Department, Hospital General Universitario Alicante, Alicante, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Garcia-Sanchez', 'Affiliation': 'Medical Oncology Service, Hospital Arnau Vilanova, Valencia, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dómine', 'Affiliation': 'Department of Oncology, Hospital Universitario Fundacion Jimenez Díaz (IIS-FJD), Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Medical Oncology Department, Hospital De La Santa Creu I Sant Pau, Barcelona, Spain.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Sanchez-Torres', 'Affiliation': 'Medical Oncology Department, Hospital Universitario de la Princesa, Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Britschgi', 'Affiliation': 'Department of Medical Oncology and Hematology, University Hospital Zurich, Comprehensive Cancer Center Zurich, Zurich, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pless', 'Affiliation': 'Cantonal Hospital Winterthur, Oncology and Haematology, Winterthur, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dimopoulou', 'Affiliation': 'Frontier Science Foundation Hellas, Athens, Greece.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Roschitzki-Voser', 'Affiliation': 'European Thoracic Oncology Platform (ETOP), Coordinating Office, Bern, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ruepp', 'Affiliation': 'European Thoracic Oncology Platform (ETOP), Coordinating Office, Bern, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Germans Trias i Pujol Research Institute (IGTP), Badalona, Barcelona, Spain; Catalan Institute of Oncology (ICO), Honorary Consultant, Barcelona, Spain.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Stahel', 'Affiliation': 'European Thoracic Oncology Platform (ETOP), Coordinating Office, Bern, Switzerland. Electronic address: Rolf.Stahel@etop-eu.org.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.11.010']
1325,34839366,How does accelerometry-measured arm elevation at work influence prospective risk of long-term sickness absence?,"OBJECTIVE


Elevated arm work is prevalent in many jobs. Feasible device-based methods are available to measure elevated arm work. However, we lack knowledge on the association between device-measured elevated arm work and prospective risk of long-term sickness absence (LTSA). We aimed to investigate this association.
METHODS


At baseline, 937 workers wore accelerometers on the right arm and thigh over 1-5 workdays to measure work time spent with elevated arms in an upright position. Between baseline and 4-year prospective follow-up in the national registers, we obtained information on the individuals` first event of LTSA (≥6 consecutive weeks). We performed compositional Cox proportional hazard analyses to model the association between work time with arm elevation >30˚, >60˚, or >90˚ and the probability of LTSA.
RESULTS


Workers spent 21% of their work time with >30˚ arm elevation, 4% with >60˚ arm elevation, and 1% with >90˚ arm elevation; in the upright body position. We found a positive dose-response association between work time spent with elevated arm work and the risk of LTSA. Specifically, we found that increasing two minutes of work time spent with arm elevation at (i) >90˚ increased the risk of LTSA by 14% [hazard ratio (HR) 1.14, 95% confidence intervals (95% CI 1.04-1.25)] (ii) >60˚ increased the LTSA risk by 3% (HR 1.03, 95% CI 1.03-1.06), and (iii) >30˚ increased the LTSA risk by 1% (HR 1.01, 95% CI 1.00-1.02).
CONCLUSION


Device-measured elevated arm work is associated with increased prospective LTSA. This information ought to be brought into preventive workplace practice by accessible and feasible device-based methods of elevated arm work.",2022,"90˚ increased the risk of LTSA by 14% [hazard ratio (HR) 1.14, 95% confidence intervals (95% CI 1.04-1.25)]",['individuals` first event of LTSA (≥6 consecutive weeks'],[],"['risk of LTSA', 'LTSA risk']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0439230', 'cui_str': 'week'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}]",,0.0482768,"90˚ increased the risk of LTSA by 14% [hazard ratio (HR) 1.14, 95% confidence intervals (95% CI 1.04-1.25)]","[{'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'National Research Centre for the Working Environment, Lerso Parkalle 105, DK-2100 Copenhagen, Denmark. ngu@nfa.dk.'}, {'ForeName': 'Charlotte Lund', 'Initials': 'CL', 'LastName': 'Rasmussen', 'Affiliation': ''}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Forsman', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Søgaard', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Holtermann', 'Affiliation': ''}]","Scandinavian journal of work, environment & health",['10.5271/sjweh.4000']
1326,34840145,Clinical application of a new hemostatic material using mussel-inspired catecholamine hemostat: A pilot study.,"Backgrounds/Aims


This study aimed to evaluate clinical application of InnoSEAL Plus (a mussel-inspired catecholamine hemostat) as a new hemostatic material for humans.
Methods


Patients treated with topical hemostatic patches after liver resection were enrolled. They were divided into an experimental group (InnoSEAL Plus group) and two control groups (TachoSil ®  group and Surgicel Fibrillar ®  group) for efficacy evaluation.
Results


A total of 15 patients were enrolled. Each group had five patients. The 3-minute hemostasis success rate was 80.0% (4/5 patients) in the InnoSEAL Plus group, 80.0% (4/5 patients) in the TachoSil ®  group, and 40.0% (2/5 patients) in the Surgicel Fibrillar ®  group, showing no significant difference in the success rate among these groups ( p  > 0.05). All three groups exhibited 100% success rate for 10-minute hemostasis. Both InnoSEAL Plus and TachoSil ®  groups had one patient developing adverse events, which were treated easily with drug administrations.
Conclusions


InnoSEAL Plus is expected to be functionally not inferior to other conventional hemostatic agents. However, it is necessary to confirm this through multicenter prospective studies in the future.",2022,"The 3-minute hemostasis success rate was 80.0% (4/5 patients) in the InnoSEAL Plus group, 80.0% (4/5 patients) in the TachoSil ®  group, and 40.0% (2/5 patients) in the Surgicel Fibrillar ®  group, showing no significant difference in the success rate among these groups ( p  > 0.05).","['A total of 15 patients were enrolled', 'after liver resection were enrolled']","['TachoSil ®', 'new hemostatic material using mussel-inspired catecholamine hemostat', 'InnoSEAL Plus (a mussel-inspired catecholamine hemostat', 'control groups (TachoSil ®  group and Surgicel Fibrillar ®  group) for efficacy evaluation', 'topical hemostatic patches']","['3-minute hemostasis success rate', 'success rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C1871272', 'cui_str': 'TachoSil'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0449902', 'cui_str': 'Material used'}, {'cui': 'C0026871', 'cui_str': 'Mussel'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0180950', 'cui_str': 'Hemostat'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0075660', 'cui_str': 'Surgicel'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}]",15.0,0.0307818,"The 3-minute hemostasis success rate was 80.0% (4/5 patients) in the InnoSEAL Plus group, 80.0% (4/5 patients) in the TachoSil ®  group, and 40.0% (2/5 patients) in the Surgicel Fibrillar ®  group, showing no significant difference in the success rate among these groups ( p  > 0.05).","[{'ForeName': 'Young-Mok', 'Initials': 'YM', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea.'}, {'ForeName': 'Hyung-Il', 'Initials': 'HI', 'LastName': 'Seo', 'Affiliation': 'Department of Surgery, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea.'}, {'ForeName': 'Jae-Hoon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Trauma Surgery and Surgical Critical Care, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea.'}, {'ForeName': 'Sung Pil', 'Initials': 'SP', 'LastName': 'Yoon', 'Affiliation': 'Department of Surgery, Gang-an Hospital, Busan, Korea.'}, {'ForeName': 'Haeshin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Chemistry, Korea Advanced Institute of Science and Technology (KAIST), Daejeon, Korea.'}, {'ForeName': 'Moon Sue', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'InnoTherapy Inc., Seoul, Korea.'}]",Annals of hepato-biliary-pancreatic surgery,['10.14701/ahbps.21-077']
1327,34842189,Anti-Inflammatory Agents: An Approach to Prevent Cognitive Decline in Alzheimer's Disease.,"Systemic inflammation is an organism's response to an assault by the non-self. However, that inflammation may predispose humans to illnesses targeted to organs, including Alzheimer's disease (AD). Lesions in AD have pro-inflammatory cytokines and activated microglial/monocyte/macrophage cells. Up to this point, clinical trials using anti-amyloid monoclonal antibodies have not shown success. Maybe it is time to look elsewhere by combating inflammation. Neuroinflammation with CNS cellular activation and excessive expression of immune cytokines is suspected as the ""principal culprit"" in the higher risk for sporadic AD. Microglia, the resident immune cell of the CNS, perivascular myeloid cells, and activated macrophages produce IL-1, IL-6 at higher levels in patients with AD. Anti-inflammatory measures that target cellular/cytokine-mediated damage provide a rational therapeutic strategy. We propose a clinical trial using oral type 1 IFNs to act as such an agent; one that decreases IL-1 and IL-6 secretion by activating lamina propria lymphocytes in the gut associated lymphoid tissue with subsequent migration to the brain undergoing inflammatory responses. A clinical trial would be double-blind, parallel 1-year clinical trial randomized 1 : 1 oral active type 1 IFN versus best medical therapy to determine whether ingested type I IFN would decrease the rate of cognitive decline in mild cognitive impairment or mild AD. Using cognitive psychometrics, imaging, and fluid biomarkers (MxA for effective type I IFN activity beyond the gut), we can determine if oral type I IFN can prevent cognitive decline in AD.",2022,"Using cognitive psychometrics, imaging, and fluid biomarkers (MxA for effective type I IFN activity beyond the gut), we can determine if oral type I IFN can prevent cognitive decline in AD.","['mild cognitive impairment or mild AD', ""Alzheimer's Disease"", 'patients with AD']",['Anti-Inflammatory Agents'],['IL-1 and IL-6 secretion'],"[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",1.0,0.51056,"Using cognitive psychometrics, imaging, and fluid biomarkers (MxA for effective type I IFN activity beyond the gut), we can determine if oral type I IFN can prevent cognitive decline in AD.","[{'ForeName': 'Staley A', 'Initials': 'SA', 'LastName': 'Brod', 'Affiliation': 'Department of Neurology, Medical College of Wisconsin, Medical College of Wisconsin, Milwaukee, WI, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-215125']
1328,34843078,"Comparison of Analgesic Effects between Nalbuphine and Sufentanil in First-Trimester Surgical Abortion: A Randomized, Double-Blind, Controlled Trial.","INTRODUCTION


Surgical abortion is one of the commonly conducted procedures worldwide. Nevertheless, pregnant women still complain of procedural and postoperative pain despite the use of advanced anesthesia. It is vital to women's reproductive healthcare to improve postsurgical pain management to achieve the lowest level of pain.
METHODS


This randomized, double-blind, parallel-controlled clinical trial compared the analgesic effects between nalbuphine and sufentanil in patients who underwent first-trimester surgical abortion. In total, 224 patients were allocated randomly into (a) the sufentanil group that received sufentanil (0.1 ug/kg) combined propofol, and (b) the nalbuphine group that received nalbuphine (0.1 mg/kg) combined propofol. Postoperative pain scores, propofol injection pain, intraoperative analgesic effect, adverse events, and degree of satisfaction were recorded as outcome measures.
RESULTS


The pain scores in the nalbuphine group were lower than those in the sufentanil group at 15 min, 30 min, 1 h, and 6 h after surgical abortion. In addition, the incidence and intensity of propofol injection pain were lower in the nalbuphine group. The degree of satisfaction of the patients in the nalbuphine group was higher than that in the sufentanil group. The intraoperative analgesic effect, hemodynamic fluctuation, and adverse events were comparable between the two groups.
CONCLUSIONS


Nalbuphine combined with propofol is superior to sufentanil combined with propofol for first-trimester abortion surgeries.
CLINICAL TRIAL REGISTRATION


The trial was registered at www.chictr.org.cn , identifier ChiCTR2000040243.",2022,"The pain scores in the nalbuphine group were lower than those in the sufentanil group at 15 min, 30 min, 1 h, and 6 h after surgical abortion.","['patients who underwent first-trimester surgical abortion', 'First-Trimester Surgical Abortion', '224 patients']","['Nalbuphine and Sufentanil', 'propofol', 'nalbuphine and sufentanil', 'sufentanil (0.1 ug/kg) combined propofol', 'nalbuphine group that received nalbuphine (0.1 mg/kg) combined propofol', 'sufentanil', 'Nalbuphine combined with propofol']","['intraoperative analgesic effect, hemodynamic fluctuation, and adverse events', 'analgesic effects', 'Postoperative pain scores, propofol injection pain, intraoperative analgesic effect, adverse events, and degree of satisfaction', 'pain scores', 'degree of satisfaction', 'incidence and intensity of propofol injection pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C4319560', 'cui_str': '224'}]","[{'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C1627892', 'cui_str': 'ug/kg'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4282968', 'cui_str': 'Propofol Injection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",224.0,0.400488,"The pain scores in the nalbuphine group were lower than those in the sufentanil group at 15 min, 30 min, 1 h, and 6 h after surgical abortion.","[{'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Fang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China.""}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China.""}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China.""}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China.""}, {'ForeName': 'Xuesheng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China. liuxuesheng@ahmu.edu.cn.""}]",Pain and therapy,['10.1007/s40122-021-00334-0']
1329,34789188,Covid-19 transmission in fitness centers in Norway - a randomized trial.,"BACKGROUND


Closed fitness centers during the Covid-19 pandemic may negatively impact health and wellbeing. We assessed whether training at fitness centers increases the risk of SARS-CoV-2 virus infection.
METHODS


In a two-group parallel randomized controlled trial, fitness center members aged 18 to 64 without Covid-19-relevant comorbidities, were randomized to access to training at a fitness center or no-access. Fitness centers applied physical distancing (1 m for floor exercise, 2 m for high-intensity classes) and enhanced hand and surface hygiene. Primary outcomes were SARS-CoV-2 RNA status by polymerase chain reaction (PCR) after 14 days, hospital admission after 21 days. The secondary endpoint was SARS-CoV-2 antibody status after 1 month.
RESULTS


3764 individuals were randomized; 1896 to the training arm and 1868 to the no-training arm. In the training arm, 81.8% trained at least once, and 38.5% trained ≥six times. Of 3016 individuals who returned the SARS-CoV-2 RNA tests (80.5%), there was one positive test in the training arm, and none in the no-training arm (risk difference 0.053%; 95% CI - 0.050 to 0.156%; p = 0.32). Eleven individuals in the training arm (0.8% of tested) and 27 in the no-training arm (2.4% of tested) tested positive for SARS-CoV-2 antibodies (risk difference - 0.87%; 95%CI - 1.52% to - 0.23%; p = 0.001). No outpatient visits or hospital admissions due to Covid-19 occurred in either arm.
CONCLUSION


Provided good hygiene and physical distancing measures and low population prevalence of SARS-CoV-2 infection, there was no increased infection risk of SARS-CoV-2 in fitness centers in Oslo, Norway for individuals without Covid-19-relevant comorbidities.
TRIAL REGISTRATION


The trial was prospectively registered in ClinicalTrials.gov on May 13, 2020. Due to administrative issues it was first posted on the register website on May 29, 2020: NCT04406909 .",2021,"No outpatient visits or hospital admissions due to Covid-19 occurred in either arm.
","['fitness center members aged 18 to 64 without Covid-19-relevant comorbidities', '3764 individuals were randomized; 1896 to the training arm and 1868 to the no-training arm']","['access to training at a fitness center or no-access', 'physical distancing (1\u2009m for floor exercise, 2\u2009m for high-intensity classes']","['SARS-CoV-2 RNA status by polymerase chain reaction (PCR', 'positive for SARS-CoV-2 antibodies', 'SARS-CoV-2 antibody status', 'hospital admission']","[{'cui': 'C0600623', 'cui_str': 'Fitness Centers'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0600623', 'cui_str': 'Fitness Centers'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",3764.0,0.133746,"No outpatient visits or hospital admissions due to Covid-19 occurred in either arm.
","[{'ForeName': 'Lise M', 'Initials': 'LM', 'LastName': 'Helsingen', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo and Oslo University Hospital, Oslo, Norway. lisemhe@medisin.uio.no.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Løberg', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo and Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Erle', 'Initials': 'E', 'LastName': 'Refsum', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo and Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Dagrun Kyte', 'Initials': 'DK', 'LastName': 'Gjøstein', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo and Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Wieszczy', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo and Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ørjan', 'Initials': 'Ø', 'LastName': 'Olsvik', 'Affiliation': 'Institute of Medical Biology, Norwegian Arctic University, Tromsø, Norway.'}, {'ForeName': 'Frederik E', 'Initials': 'FE', 'LastName': 'Juul', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo and Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ishita', 'Initials': 'I', 'LastName': 'Barua', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo and Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Henriette C', 'Initials': 'HC', 'LastName': 'Jodal', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo and Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Magnhild', 'Initials': 'M', 'LastName': 'Herfindal', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo and Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Mori', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo and Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Jore', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Fridtjof', 'Initials': 'F', 'LastName': 'Lund-Johansen', 'Affiliation': 'Department of Immunology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Atle', 'Initials': 'A', 'LastName': 'Fretheim', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bretthauer', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo and Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Kalager', 'Affiliation': 'Clinical Effectiveness Research Group, University of Oslo and Oslo University Hospital, Oslo, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC public health,['10.1186/s12889-021-12073-0']
1330,34791548,"Apical approach in periodontal reconstructive surgery with enamel matrix derivate and enamel matrix derivate plus bone substitutes: a randomized, controlled clinical trial.","OBJECTIVES


This parallel, randomized controlled clinical trial evaluated the influence of bone substitutes (BS) on the efficacy of the non-incised papillae surgical approach (NIPSA) with enamel matrix derivate (EMD) in resolving deep, isolated, combined non-contained intrabony and supra-alveolar periodontal defects, preserving the soft tissue.
MATERIAL AND METHODS


Twenty-four patients were randomized to treatment with NIPSA and EMD or NIPSA plus EMD and BS. Bleeding on probing (BoP), interproximal clinical attachment level (CAL), interproximal probing depth (PD), recession (REC), location of the tip of the papilla (TP), and width of the keratinized tissue (KT) were evaluated before surgery and at 1 year post-surgery (primary outcomes). Wound closure was assessed at 1 week post-surgery, and supra-alveolar attachment gain (SUPRA-AG) was recorded at 1 year post-surgery.
RESULTS


At 1 week, 87.5% of cases registered complete wound closure and there were no cases of necrosis, without differences between groups (p > .05). At 1 year, all cases showed negative BoP. A significant PD reduction (NIPSA + EMD 8.25 ± 2.70 mm vs. NIPSA + EMD + BS 6.83 ± 0.81 mm) and CAL gain (NIPSA + EMD 8.33 ± 2.74 mm vs. NIPSA + EMD + BS 7.08 ± 2.68 mm) were observed (p < .001) in both groups, without significant between-group differences (p > .05). The residual PD was < 5 mm in all defects (NIPSA + EMD 2.50 ± 0.67 mm vs. NIPSA + EMD + BS 2.67 ± 0.78 mm). Soft tissues were preserved without significant between-group differences (REC: NIPSA + EMD 0.25 ± 0.45 mm vs. NIPSA + EMD + BS 0.17 ± 0.58 mm, p > .05; KT: 0.00 ± 0.43 mm vs. 0.08 ± 0.67 mm, p > .05). There were improvements in the papilla in both groups (TP: NIPSA + EMD 0.33 ± 0.49 mm vs. NIPSA + EMD + BS 0.45 ± 0.52 mm, p > .05), which was only significant in the NIPSA EMD + BS group (0.45 ± 0.52 mm; p < .05). In both groups, CAL gain was recorded in the supra-alveolar component, showing full resolution of the intrabony component of the defect in all cases (SUPRA-AG: NIPSA + EMD 1.83 ± 1.11 mm vs. NIPSA + EMD + BS 2.00 ± 1.76 mm, p > .05).
CONCLUSIONS


NIPSA and EMD with or without BS seem to be a valid surgical approach in the treatment of isolated, deep non-contained periodontal defects. In our study, both treatments resulted in significant PD reduction and CAL gain, that extended in the supra-alveolar component, without differences with the use of BS. Both treatments resulted in soft tissue preservation. However, the addition of BS may improve interdental papillary tissue.
CLINICAL RELEVANCE


NIPSA, with or without bone substitutes, resulted in significant periodontal improvement, with soft tissue preservation in isolated, deep non-contained periodontal defects. The application of bone substitutes may provide interproximal soft tissue gain.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov: NCT04712630.",2022,"At 1 week, 87.5% of cases registered complete wound closure and there were no cases of necrosis, without differences between groups (p > .05).","['Twenty-four patients', 'periodontal reconstructive surgery with enamel matrix derivate and']","['enamel matrix derivate plus bone substitutes', 'bone substitutes (BS', 'non-incised papillae surgical approach (NIPSA) with enamel matrix derivate (EMD', 'NIPSA and EMD or NIPSA plus EMD and BS']","['CAL gain', 'residual PD', 'Bleeding on probing (BoP), interproximal clinical attachment level (CAL), interproximal probing depth (PD), recession (REC), location of the tip of the papilla (TP), and width of the keratinized tissue (KT', 'interdental papillary tissue', 'Soft tissues', 'negative BoP. A significant PD reduction', 'PD reduction and CAL gain', 'supra-alveolar attachment gain (SUPRA-AG', 'soft tissue preservation', 'Wound closure', 'complete wound closure']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0243003', 'cui_str': 'Bone Substitute'}, {'cui': 'C0449446', 'cui_str': 'Surgical approach'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0442104', 'cui_str': 'Interdental'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",24.0,0.0961717,"At 1 week, 87.5% of cases registered complete wound closure and there were no cases of necrosis, without differences between groups (p > .05).","[{'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Moreno Rodríguez', 'Affiliation': ', Murcia, Spain. joseantonio171087@gmail.com.'}, {'ForeName': 'Antonio José', 'Initials': 'AJ', 'LastName': 'Ortiz Ruiz', 'Affiliation': 'Department of Stomatology, Faculty of Medicine, University of Murcia, Murcia, Spain.'}]",Clinical oral investigations,['10.1007/s00784-021-04256-1']
1331,34791634,Improved Treatment Effect of Triamcinolone Acetonide Extended-Release in Patients with Concordant Baseline Pain Scores on the Average Daily Pain and Western Ontario and McMaster Universities Osteoarthritis Index Pain Scales.,"INTRODUCTION


A phase 3 randomized controlled study comparing triamcinolone acetonide extended-release (TA-ER) to conventional TA crystalline suspension (TAcs) reported variable efficacy results. Enrollment criteria may have contributed to this discrepancy, as moderate-to-severe average daily pain (ADP) was required at baseline, whereas no limitations were placed on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A) pain severity. We conducted a post hoc sensitivity analysis to compare treatment effects in patients reporting moderate-to-severe osteoarthritis (OA) pain on both scales.
METHODS


Participants > 40 years old with symptomatic knee OA were randomly assigned to a single intra-articular injection of TA-ER 32 mg, TAcs 40 mg, or saline-placebo and followed for 24 weeks. Patient-reported ADP, WOMAC-A, rescue medication usage, and adverse events (AEs) were assessed. Participants who reported moderate-to-severe OA pain at baseline using both instruments (ADP ≥ 5 to ≤ 9, maximum 10 and WOMAC-A ≥ 2, maximum 4) were categorized as ""concordant"" pain reporters; patients with baseline moderate-to-severe OA on ADP only were termed ""discordant"" pain reporters.
RESULTS


Two-hundred-ninety-two concordant pain reporters of 484 total subjects received TA-ER 32 mg (n = 95), TAcs 40 mg (n = 100), or saline-placebo (n = 97). Baseline characteristics and AE profiles of the concordant and discordant pain responders were consistent with the full analysis population. Among concordant pain reporters, TA-ER significantly (p < 0.05) improved ADP scores vs. TAcs (weeks 5-19; area-under-the-effect [AUE] weeks1-12 ; AUE weeks1-24 ) and saline-placebo (weeks 1-20; AUE weeks1-12 ; AUE weeks1-24 ). At week 12, a higher proportion reported no knee pain (ADP = 0) with TA-ER (~ 28%) vs. TAcs (~ 8%). TA-ER significantly improved WOMAC-A vs. TAcs at weeks 4, 8, and 12, with significant reduction in rescue medication usage observed with TA-ER from weeks 2 to 20 vs. TAcs.
CONCLUSIONS


In patients reporting moderate-to-severe knee OA pain at baseline based on concordant ADP and WOMAC-A scores, TA-ER provided statistically significant pain relief for ≥ 12 weeks compared with conventional TAcs.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02357459.",2022,"TA-ER significantly improved WOMAC-A vs. TAcs at weeks 4, 8, and 12, with significant reduction in rescue medication usage observed with TA-ER from weeks 2 to 20 vs. TAcs.
","['40\xa0years old with symptomatic knee OA', 'Patients with Concordant', 'patients reporting moderate-to-severe osteoarthritis (OA) pain on both scales', 'Participants who reported moderate-to-severe OA pain at baseline using both instruments (ADP\u2009≥\u20095 to\u2009≤\u20099, maximum 10 and WOMAC-A\u2009≥\u20092, maximum 4) were categorized as ""concordant"" pain reporters; patients with baseline moderate-to-severe OA on ADP only were termed ""discordant"" pain reporters', 'Participants\u2009', 'Two-hundred-ninety-two concordant pain reporters of 484 total subjects received']","['TA-ER', 'Triamcinolone Acetonide', 'saline-placebo', 'triamcinolone acetonide extended-release (TA-ER', 'conventional TA crystalline suspension (TAcs', 'single intra-articular injection of TA-ER 32\xa0mg, TAcs 40\xa0mg, or saline-placebo']","['ADP scores', 'Average Daily Pain and Western Ontario and McMaster Universities Osteoarthritis Index Pain Scales', 'pain relief', 'Baseline Pain Scores', 'knee pain', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A) pain severity', 'ADP, WOMAC-A, rescue medication usage, and adverse events (AEs']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0335038', 'cui_str': 'Reporter'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0444626', 'cui_str': 'Crystal'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.499593,"TA-ER significantly improved WOMAC-A vs. TAcs at weeks 4, 8, and 12, with significant reduction in rescue medication usage observed with TA-ER from weeks 2 to 20 vs. TAcs.
","[{'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Ross', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA. elross@bwh.harvard.edu.""}, {'ForeName': 'Nathaniel P', 'Initials': 'NP', 'LastName': 'Katz', 'Affiliation': 'Analgesic Solutions, 321 Commonwealth Rd, Wayland, MA, 01778, USA.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, LS7 4SA, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, 178 Meadowbrook Lane, P.O. Box 1018, Duncansville, PA, 16635, USA.'}, {'ForeName': 'Dennis C', 'Initials': 'DC', 'LastName': 'Turk', 'Affiliation': 'Washington Medicine, Box 356540, 1949 NE Pacific Street, Seattle, WA, 98195, USA.'}, {'ForeName': 'Andrew I', 'Initials': 'AI', 'LastName': 'Spitzer', 'Affiliation': 'Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, 444 S. San Vicente Blvd #603, Los Angeles, CA, 90048, USA.'}, {'ForeName': 'Deryk G', 'Initials': 'DG', 'LastName': 'Jones', 'Affiliation': 'Ochsner Sports Medicine Institute, 1221 S. Clearview Pkwy, Harahan, LA, 70121, USA.'}, {'ForeName': 'Ryan K', 'Initials': 'RK', 'LastName': 'Lanier', 'Affiliation': 'Analgesic Solutions, 321 Commonwealth Rd, Wayland, MA, 01778, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cinar', 'Affiliation': 'Flexion Therapeutics Inc., 10 Mall Road, Suite 301, Burlington, MA, 01803, USA.'}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Lufkin', 'Affiliation': 'Flexion Therapeutics Inc., 10 Mall Road, Suite 301, Burlington, MA, 01803, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Kelley', 'Affiliation': 'Flexion Therapeutics Inc., 10 Mall Road, Suite 301, Burlington, MA, 01803, USA.'}]",Pain and therapy,['10.1007/s40122-021-00335-z']
1332,34793868,Non-invasive evaluation of response to obeticholic acid in patients with NASH: Results from the REGENERATE study.,"BACKGROUND & AIMS


Non-alcoholic steatohepatitis (NASH) is a chronic, progressive fibrotic liver disease that can lead to cirrhosis. While liver biopsy is considered the reference standard for the histologic diagnosis of NASH and staging of fibrosis, its use in clinical practice is limited. Non-invasive tests (NITs) are increasingly being used to identify and stage liver fibrosis in patients with NASH, and several can assess liver-related outcomes. We report changes in various NITs in patients treated with obeticholic acid (OCA) or placebo in the phase III REGENERATE study.
METHODS


Patients with NASH and fibrosis stage F2 or F3 (n = 931) were randomized (1:1:1) to receive placebo, OCA 10 mg, or OCA 25 mg once daily. Various NITs based on clinical chemistry and/or imaging were evaluated at baseline and throughout the study.
RESULTS


Rapid, sustained reductions from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyltransferase levels, as well as in Fibrosis-4 (FIB-4), FibroTest, FibroMeter, and FibroScan-AST scores were observed in OCA-treated vs. placebo-treated patients. Reduction in liver stiffness by vibration-controlled transient elastography was observed in the OCA 25 mg group vs. the placebo group at Month 18. NIT changes were associated with shifts in histologic fibrosis stage. The greatest improvements were observed in patients with ≥1-stage fibrosis improvement; however, improvements in ALT, AST, FIB-4, and FibroTest were also observed in OCA-treated patients whose histologic fibrosis remained stable.
CONCLUSIONS


Based on the REGENERATE Month 18 interim analysis, rapid and sustained improvements in various NITs were observed with OCA treatment. Dynamic changes in selected NITs separated histologic responders from non-responders. These results suggest that NITs may be useful in assessing histologic response to OCA therapy. CLINICALTRIALS.
GOV NUMBER


NCT02548351 LAY SUMMARY: Non-alcoholic steatohepatitis (NASH) is a chronic, progressive liver disease that can lead to cirrhosis. To diagnose and assess liver fibrosis (scarring) in patients with NASH, non-invasive tests (NITs) are increasingly being used rather than liver biopsy, which is invasive, expensive, and can be risky. In the REGENERATE study, which is evaluating the effects of obeticholic acid vs. placebo in patients with NASH, various NITs were also evaluated. This analysis shows that improvements in levels of certain blood components, as well as favorable results of ultrasound imaging and proprietary tests of liver function, were associated with improvements in liver fibrosis after treatment with obeticholic acid, suggesting that NITs may be useful alternatives to liver biopsy in assessing NASH patients' response to therapy.",2022,Reduction in liver stiffness by vibration-controlled transient elastography (VCTE) was observed in the OCA 25 mg group versus placebo group at Month 18.,"['Patients with NASH and fibrosis stage F2 or F3 (N = 931', 'patients treated with', 'patients with NASH, noninvasive tests (NITs', 'patients with NASH', 'patients with NASH, various NITs']","['placebo, OCA 10 mg, or OCA', 'obeticholic acid', 'Nonalcoholic steatohepatitis (NASH', 'obeticholic acid versus placebo', 'obeticholic acid (OCA) or placebo', 'placebo']","['ALT, AST, FIB-4, and FibroTest', 'histologic fibrosis stage', 'FibroScan-AST scores', 'alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT) levels, as well as in FIB-4, FibroTest, FibroMeter, and', 'liver stiffness', 'liver fibrosis (scarring', 'liver fibrosis', 'histologic response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4271665', 'cui_str': 'obeticholic acid 10 MG [Ocaliva]'}, {'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}]",931.0,0.0944592,Reduction in liver stiffness by vibration-controlled transient elastography (VCTE) was observed in the OCA 25 mg group versus placebo group at Month 18.,"[{'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Rinella', 'Affiliation': 'Department of Medicine, Gastroenterology and Hepatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Dufour', 'Affiliation': 'University Clinic for Visceral Surgery and Medicine, Inselspital, Bern, Switzerland; Hepatology, Department for BioMedical Research, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Quentin M', 'Initials': 'QM', 'LastName': 'Anstee', 'Affiliation': 'The Newcastle Liver Research Group, Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom; Newcastle NIHR Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Goodman', 'Affiliation': 'Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, USA.'}, {'ForeName': 'Zobair', 'Initials': 'Z', 'LastName': 'Younossi', 'Affiliation': 'Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Pinnacle Clinical Research Center, San Antonio, TX, USA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bonacci', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Trylesinski', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Macky', 'Initials': 'M', 'LastName': 'Natha', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Shringarpure', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Granston', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Venugopal', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Ratziu', 'Affiliation': 'Sorbonne Université, Assistance Publique-Hôpitaux de Paris, Hôpital Pitié - Salpêtrière, Institute for Cardiometabolism and Nutrition, INSERM UMRS 1138 CRC, Paris, France. Electronic address: vlad.ratziu@inserm.fr.'}]",Journal of hepatology,['10.1016/j.jhep.2021.10.029']
1333,34797431,Accuracy and primary stability of tapered or straight implants placed into fresh extraction socket using dynamic navigation: a randomized controlled clinical trial.,"OBJECTIVES


To compare the accuracy and primary stability of tapered and straight implants undergoing immediate implant placement with dynamic navigation.
MATERIALS AND METHODS


Patients with compromised anterior teeth in maxilla were recruited and allocated randomly into (1) tapered implant group (TI group) and (2) straight implant group (SI group). Implants were inserted into fresh sockets with dynamic navigation. Three-dimensional platform deviation, apex deviation, angular deviation, insertion torque value (ITV) and implant stability quotient (ISQ) were recorded.
RESULTS


Twenty patients with 20 implants were included. The overall platform, apex, and angular deviation were 0.87 ± 0.35 mm, 0.81 ± 0.34 mm, and 2.40 ± 1.31°, respectively. The accuracy was 0.86 ± 0.26 mm, 0.76 ± 0.33 mm, and 2.49 ± 1.54° for TI, and 0.89 ± 0.44 mm, 0.88 ± 0.36 mm, and 2.31 ± 1.01° for SI, with no significant difference (p = 0.85, 0.45, 0.76). Sagittal root position classification (SRP) class I may obtain greater error in numerical values in straight implants (0.97 ± 0.47 mm vs. 0.6 ± 0.16 mm, 0.92 ± 0.36 mm vs. 0.73 ± 0.36 mm, 2.48 ± 1.19° vs. 1.71 ± 0.14°). The overall ISQ was 60.74. ISQ was 60.48 for TI and 60.96 for SI, with no significant difference. Acceptable ITV (> 15 Ncm) was achieved in most of the included patients (SI 7/10, TI 9/10).
CONCLUSIONS


High accuracy and primary stability of immediate implant placement could be achieved both in tapered and straight implants with dynamic navigation systems.
CLINICAL RELEVANCE


Tapered and straight implants did not reach a consensus on which was better in immediate implant regarding to accuracy and primary stability. Our study demonstrated implant macrodesign did not affect accuracy and primary stability in immediate implant using dynamic navigation.",2022,Tapered and straight implants did not reach a consensus on which was better in immediate implant regarding to accuracy and primary stability.,"['Patients with compromised anterior teeth in maxilla', 'Twenty patients with 20 implants were included']","['Sagittal root position classification (SRP) class', 'straight implants placed into fresh extraction socket using dynamic navigation', 'tapered implant group (TI group) and (2) straight implant group (SI group', 'tapered and straight implants undergoing immediate implant placement with dynamic navigation']","['ISQ', 'dimensional platform deviation, apex deviation, angular deviation, insertion torque value (ITV) and implant stability quotient (ISQ', 'overall ISQ', 'Acceptable ITV', 'overall platform, apex, and angular deviation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}]",20.0,0.176904,Tapered and straight implants did not reach a consensus on which was better in immediate implant regarding to accuracy and primary stability.,"[{'ForeName': 'Shi-Min', 'Initials': 'SM', 'LastName': 'Wei', 'Affiliation': ""Department of Oral and Maxillo-Facial Implantology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China.""}, {'ForeName': 'Jun-Yu', 'Initials': 'JY', 'LastName': 'Shi', 'Affiliation': ""Department of Oral and Maxillo-Facial Implantology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China.""}, {'ForeName': 'Shi-Chong', 'Initials': 'SC', 'LastName': 'Qiao', 'Affiliation': ""Department of Oral and Maxillo-Facial Implantology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China.""}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Oral and Maxillo-Facial Implantology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China.""}, {'ForeName': 'Hong-Chang', 'Initials': 'HC', 'LastName': 'Lai', 'Affiliation': ""Department of Oral and Maxillo-Facial Implantology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China. lhc9@hotmail.com.""}, {'ForeName': 'Xiao-Meng', 'Initials': 'XM', 'LastName': 'Zhang', 'Affiliation': ""Department of Oral and Maxillo-Facial Implantology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, National Clinical Research Center for Oral Diseases, Shanghai Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China. zhangxiaomengwowo@126.com.""}]",Clinical oral investigations,['10.1007/s00784-021-04247-2']
1334,34798474,Broad conceptualisations of beauty do not moderate women's responses to body positive content on instagram.,"Body positive content on Instagram may act as an antidote to the frequent depictions of thin and digitally modified images of women. Body positivity challenges narrow ideals by promoting diverse appearances and encouraging body appreciation. We examined the effects of congruent body positive messaging (unedited images of a diverse range of women presented with and without body acceptance captions) on state body image. This was the first study to investigate the moderating role of trait broad conceptualisation of beauty; a core component of body positive content and theories. Women 18-30 years (N = 233) were randomly assigned to view Instagram images of diverse women (e.g., varied body sizes, shapes, skin colour), either presented with or without body positive captions, or cityscape images. Pre- and post-test measures were taken of state body appreciation, appearance satisfaction, and positive mood, in addition to social comparison measures. Body appreciation and positive mood increased in all conditions. Appearance satisfaction only increased in the body positive conditions, with a larger effect size in the caption condition. Holding broad conceptualisations of beauty did not moderate findings. Captions did not change direction or amount of social comparison. Findings suggest that congruent body positive content may increase appearance satisfaction in viewers.",2022,Body appreciation and positive mood increased in all conditions.,['Women 18-30 years (N\xa0=\xa0233'],"['view Instagram images of diverse women (e.g., varied body sizes, shapes, skin colour), either presented with or without body positive captions, or cityscape images']","['appearance satisfaction', 'Body appreciation and positive mood', 'Appearance satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005901', 'cui_str': 'Body Size'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0475704', 'cui_str': 'Finding of color of skin'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",233.0,0.0119916,Body appreciation and positive mood increased in all conditions.,"[{'ForeName': 'Taylah M', 'Initials': 'TM', 'LastName': 'Manning', 'Affiliation': 'University of the Sunshine Coast, School of Health and Behavioural Sciences, Australia.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'University of the Sunshine Coast, School of Health and Behavioural Sciences, Australia. Electronic address: kmulgrew@usc.edu.au.'}]",Body image,['10.1016/j.bodyim.2021.10.009']
1335,34798349,Novel laser activated photoacoustic streaming for removing pulp remnants from round root canals after single file reciprocating instrumentation.,"BACKGROUND


This study evaluated the efficacy of a new laser-assisted irrigation system, the shock wave enhanced emission photo-acoustic streaming (SWEEPS) technique in removing pulp tissue from single-rooted premolars.
METHODS


Freshly extracted mandibular premolars with round root canals (n = 40), scanned using cone beam computed tomography, were randomly divided into control and four experimental (according to the irrigation technique used) groups (n = 8/group). Groups 1, 2, and 3 were instrumented using Reciproc Blue (RB25/0.06) followed by final irrigation protocol (FIP), activated by SWEEPS, ultrasonically activated irrigation (UAI), and conventional irrigation (CI), respectively. In these groups, 7 mL 3% NaOCl in total was used during instrumentation; for FIP, 3% NaOCl (60 s), ethylenediaminotetraacetic acid (60 s), and 3% NaOCl (30 s). In group 4, SWEEPS activation of 3% NaOCl for 6 × 30 s alone was performed. The untreated control group specimens were processed for histological evaluation of remaining pulp tissue (RPT) in each canal third. The results were analyzed using the Mann-Whitney U test (α = 0.05).
RESULTS


Significant differences were observed between the control group and the experimental groups (p<0.05). In the middle third, the UIA and SWEEPS showed similar efficacy (p = 0.171), superior to CI and SWEEPS without instrumentation (p<0.05). In the apical third, SWEEPS was the most efficient (p = 0.002), and UIA and CI showed no difference (p = 0.643).
CONCLUSION


SWEEPS was superior to UIA and CI in removing RPT in the apical region of round canals after single instrument root canal preparation; SWEEPS without instrumentation was inefficient in removing pulp tissue.",2022,"In the apical third, SWEEPS was the most efficient (p=0.002), and UIA and CI showed no difference (p=0.643).
","['Freshly extracted mandibular premolars with round root canals (n=40), scanned using cone beam computed tomography']","['Novel laser activated photoacoustic streaming', 'ethylenediaminotetraacetic acid', 'Reciproc Blue (RB25/.06) followed by final irrigation protocol (FIP), activated by SWEEPS, ultrasonically activated irrigation (UAI), and conventional irrigation (CI', 'new laser-assisted irrigation system, the shock wave enhanced emission photo-acoustic streaming (SWEEPS) technique']",['histological evaluation of remaining pulp tissue (RPT'],"[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",,0.0220105,"In the apical third, SWEEPS was the most efficient (p=0.002), and UIA and CI showed no difference (p=0.643).
","[{'ForeName': 'Ivona', 'Initials': 'I', 'LastName': 'Bago', 'Affiliation': 'Department of Endodontics and Restorative Dentistry, School of Dental Medicine, University of Zagreb, Croatia. Electronic address: bago@sfzg.hr.'}, {'ForeName': 'Lovorka', 'Initials': 'L', 'LastName': 'Batelja-Vuletić', 'Affiliation': 'Department of Pathology, University of Zagreb School of Medicine, Croatia.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Tarle', 'Affiliation': 'Private Dental Polyclinic, Zagreb, Croatia.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Sesar', 'Affiliation': 'Dental Polyclinic Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Ivica', 'Initials': 'I', 'LastName': 'Anić', 'Affiliation': 'Dental Polyclinic Zagreb, Zagreb, Croatia.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102631']
1336,34799682,Randomized controlled experimental study of hydrocortisone and D-cycloserine effects on fear extinction in PTSD.,"Fear extinction underlies prolonged exposure, one of the most well-studied treatments for posttraumatic stress disorder (PTSD). There has been increased interest in exploring pharmacological agents to enhance fear extinction learning in humans and their potential as adjuncts to PE. The objective of such adjuncts is to augment the clinical impact of PE on the durability and magnitude of symptom reduction. In this study, we examined whether hydrocortisone (HC), a corticosteroid, and D-Cycloserine (DCS), an N-methyl-D-aspartate receptor partial agonist, enhance fear extinction learning and consolidation in individuals with PTSD. In a double-blind placebo-controlled 3-group experimental design, 90 individuals with full or subsyndromal PTSD underwent fear conditioning with stimuli that were paired (CS+) or unpaired (CS-) with shock. Extinction learning occurred 72 h later and extinction retention was tested one week after extinction. HC 25 mg, DCS 50 mg or placebo was administered one hour prior to extinction learning. During extinction learning, the DCS and HC groups showed a reduced differential CS+/CS- skin conductance response (SCR) compared to placebo (b = -0.19, CI = -0.01 to -37, p = 0.042 and b = -0.25, CI = -08 to -0.43, p = 0.005, respectively). A nonsignificant trend for a lower differential CS+/CS- SCR in the DCS group, compared to placebo, (b = -0.25, CI = 0.04 to -0.55, p = 0.089) was observed at retention testing, one week later. A single dose of HC and DCS facilitated fear extinction learning in participants with PTSD symptoms. While clinical implications have yet to be determined, our findings suggest that glucocorticoids and NMDA agonists hold promise for facilitating extinction learning in PTSD.",2021,"A nonsignificant trend for a lower differential CS+/CS- SCR in the DCS group, compared to placebo, (b = -0.25, CI = 0.04 to -0.55, p = 0.089) was observed at retention testing, one week later.","['90 individuals with full or subsyndromal PTSD underwent', 'individuals with PTSD', 'participants with PTSD symptoms', 'fear extinction in PTSD']","['hydrocortisone (HC), a corticosteroid, and D-Cycloserine (DCS), an N-methyl-D-aspartate receptor partial agonist', 'HC and DCS', 'HC 25\u2009mg, DCS 50\u2009mg or placebo', 'hydrocortisone and D-cycloserine', 'placebo', 'fear conditioning with stimuli that were paired (CS+) or unpaired (CS-) with shock']","['differential CS+/CS- SCR', 'Extinction learning', 'extinction retention', 'fear extinction learning', 'differential CS+/CS- skin conductance response (SCR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0036974', 'cui_str': 'Shock'}]","[{'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",90.0,0.305113,"A nonsignificant trend for a lower differential CS+/CS- SCR in the DCS group, compared to placebo, (b = -0.25, CI = 0.04 to -0.55, p = 0.089) was observed at retention testing, one week later.","[{'ForeName': 'Sabra S', 'Initials': 'SS', 'LastName': 'Inslicht', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA. Sabra.Inslicht@UCSF.edu.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Niles', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Metzler', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': ""Sa'ar L"", 'Initials': 'SL', 'LastName': 'Lipshitz', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, CA, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Charité-Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Mohammed R', 'Initials': 'MR', 'LastName': 'Milad', 'Affiliation': 'Grossman School of Medicine, New York University, New York, NY, USA.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Orr', 'Affiliation': 'Massachusetts General Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Marmar', 'Affiliation': 'Grossman School of Medicine, New York University, New York, NY, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-01222-z']
1337,34801745,A comparative proteomic analysis to define the influencing factors on gingival crevicular fluid using LC-MS/MS.,"Gingival crevicular fluid (GCF) is a promising biofluid for disease identification and biomarker searching in periodontology. This study aimed to investigate the possible influencing factors, including tooth site, sex and age, on the normal GCF proteome. Forty periodontal healthy adults were randomly divided into a training group and a testing group. In the training group, GCF samples from 12 adults were analyzed using the iTRAQ 2D LC-MS/MS method. The influencing factors, tooth site (including periodontitis-susceptible and -insusceptible tooth sites), sex and age, and related differential proteins were defined and functionally annotated. The important differential proteins from 28 adults in the testing group were then validated by PRM analysis. An average of approximately 5 differential proteins were found between tooth sites of periodontitis-susceptible and -insusceptible sites. Eighty-five differentially expressed proteins were obtained between sexes in the young group, while only 7 sex-associated proteins were found in the old group. A total of 203 and 235 age-associated proteins were found in the male and female groups, respectively. The differential protein functional annotation showed that sex-related proteins were mainly related to immune function and metabolism, and age-related proteins were primarily associated with inflammation, lipid metabolism and immune function. In the testing group, a total of 4 sex-related proteins and 12 age-related proteins were validated by PRM analysis. SIGNIFICANCE: The influences of tooth site, sex and age in GCF proteomics in periodontal health were firstly analyzed using LC-MS/MS. Tooth site showed a small influence on the GCF proteome. The sex effect was significant in young adults, but its influence in old adults is small. Age is an important impact factor for the GCF proteome. These findings enrich the knowledge about the normal GCF proteome and might benefit future disease analyses.",2022,An average of approximately 5 differential proteins were found between tooth sites of periodontitis-susceptible and -insusceptible sites.,"['28 adults in the testing group were then validated by PRM analysis', 'A total of 203 and 235 age-associated proteins were found in the male and female groups, respectively', 'Forty periodontal healthy adults']",['Gingival crevicular fluid (GCF'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}]",[],12.0,0.0142519,An average of approximately 5 differential proteins were found between tooth sites of periodontitis-susceptible and -insusceptible sites.,"[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of stomatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences&Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Core Facility of Instrument, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences, School of Basic Medicine, Peking Union Medical College, Beijing, China; Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences&Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Mu', 'Affiliation': 'Department of stomatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences&Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yao Ran', 'Initials': 'YR', 'LastName': 'Liu', 'Affiliation': 'Department of stomatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences&Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Department of stomatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences&Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of stomatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences&Peking Union Medical College, Beijing, China. Electronic address: liqian4230@pumch.cn.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Core Facility of Instrument, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences, School of Basic Medicine, Peking Union Medical College, Beijing, China. Electronic address: sunwei@ibms.pumc.edu.cn.'}]",Journal of proteomics,['10.1016/j.jprot.2021.104421']
1338,34808255,"Randomized Phase 3, Double-Blind, Placebo-Controlled Study of Prophylactic Gabapentin for the Reduction of Oral Mucositis Pain During the Treatment of Oropharyngeal Squamous Cell Carcinoma.","PURPOSE


The purpose of this paper is to determine whether prophylactic gabapentin usage in patients undergoing definitive concurrent chemotherapy and radiation therapy (chemoRT) for oropharyngeal cancer (OPC) improves treatment-related oral mucositis pain, opioid use, and feeding tube (FT) placement.
METHODS AND MATERIALS


This double-blind, randomized phase 3 study for patients with locally advanced OPC undergoing chemoRT randomly allocated patients to prophylactic gabapentin (600 mg thrice daily) or placebo. The primary endpoint was change in Patient-Reported Oral Mucositis Symptom (PROMS) scores over the entire treatment period (baseline to 6 weeks post-radiation therapy [RT] follow-up) with higher scores indicating worse outcomes. Opioid requirements, FT placement, and other patient-reported quality of life (QOL) metrics (Functional Assessment of Cancer Therapy-Head and Neck [FACT-HN] and Patient-Reported Outcomes version of the National Cancer Institute Common Terminology Criteria for Adverse Events [PRO-CTCAE]) were assessed. Lower scores suggested poorer QOL with the FACT-HN questionnaire, and higher scores suggested worse outcomes with the PRO-CTCAE questionnaire. Questionnaires were administered at baseline, weekly during RT, and at 6 weeks post-RT follow-up. Repeated measures analysis of variance was used to detect differences in PROMS scores and change in opioid use from baseline. Wilcoxon rank sum tests were used to compare averages for the other secondary endpoints. A P value less than .05 was considered statistically significant.
RESULTS


Treatment arms were well balanced overall, including T and N staging and dosimetric variables. There were 58 patients analyzed. No significant difference was found in PROMS scores (mean 29.1, standard deviation [SD] 22.5 vs 20.1, SD 16.8 for gabapentin vs placebo, respectively, P = .11). The FACT-HN functional well-being index had a significant decrease in scores from baseline to follow-up in the gabapentin arm (median -6, interquartile range [IQR] -10.0 to -0.5 vs -1, IQR -5.5 to 3.0, P = .03). PRO-CTCAE scores increased significantly at follow-up for gabapentin (median 6.5, IQR 3.5-11.8 vs 1, IQR -2.0 to 6.0, P = .01). There was no significant difference in average or change in opioid use. FT placement was significantly higher in the gabapentin arm (62.1% vs 20.7%, P < .01).
CONCLUSIONS


This study suggests that prophylactic gabapentin is not effective in improving treatment-related oral mucositis symptoms in a select population of patients with OPC undergoing definitive chemoRT.",2022,"The FACT-HN functional well-being index had a significant decrease in scores from baseline to follow-up in the gabapentin arm (median -6, interquartile range [IQR] -10.0 to -0.5, vs -1, IQR -5.5 to 3.0, p = .03).","['patients with OPC undergoing definitive chemoRT', 'Oropharyngeal Squamous Cell Carcinoma', 'patients with locally advanced OPC undergoing chemoRT randomly allocated patients to', 'patients undergoing definitive concurrent chemoradiotherapy (chemoRT) for oropharyngeal cancer (OPC']","['Placebo', 'gabapentin', 'Prophylactic Gabapentin', 'prophylactic gabapentin', 'placebo']","['FT placement', 'quality of life (QOL', 'PRO-CTCAE scores', 'Oral Mucositis Pain', 'change in Patient-Reported Oral Mucositis Symptom (PROMS) scores', 'QOL metrics (Functional Assessment of Cancer Therapy-Head and Neck', 'PROMS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0041281', 'cui_str': 'Tube feeding of patient'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}]",,0.468669,"The FACT-HN functional well-being index had a significant decrease in scores from baseline to follow-up in the gabapentin arm (median -6, interquartile range [IQR] -10.0 to -0.5, vs -1, IQR -5.5 to 3.0, p = .03).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cook', 'Affiliation': 'Departments of Radiation Oncology, Henry Ford Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Modh', 'Affiliation': 'Department of Radiation Oncology, Mercy Health-Perrysburg Cancer Center, Perrysburg, Ohio.'}, {'ForeName': 'Haythem', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Departments of Medical Oncology, Henry Ford Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'Jawad', 'Initials': 'J', 'LastName': 'Sheqwara', 'Affiliation': 'Departments of Medical Oncology, Henry Ford Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'Departments of Otolaryngology, Henry Ford Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'Tamer', 'Initials': 'T', 'LastName': 'Ghanem', 'Affiliation': 'Departments of Otolaryngology, Henry Ford Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'Suhael', 'Initials': 'S', 'LastName': 'Momin', 'Affiliation': 'Departments of Otolaryngology, Henry Ford Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Wu', 'Affiliation': 'Departments of Otolaryngology, Henry Ford Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Tam', 'Affiliation': 'Departments of Otolaryngology, Henry Ford Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Money', 'Affiliation': 'Departments of Pain Medicine, Henry Ford Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Public Health Sciences, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Lamis', 'Initials': 'L', 'LastName': 'Fakhoury', 'Affiliation': 'Departments of Radiation Oncology, Henry Ford Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Movsas', 'Affiliation': 'Departments of Radiation Oncology, Henry Ford Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'Farzan', 'Initials': 'F', 'LastName': 'Siddiqui', 'Affiliation': 'Departments of Radiation Oncology, Henry Ford Cancer Institute, Detroit, Michigan. Electronic address: fsiddiq2@hfhs.org.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.11.012']
1339,34813391,Beneficial Effects of Noninvasive Ventilation after Extubation in Obese or Overweight Patients: A  Post Hoc  Analysis of a Randomized Clinical Trial.,"Rationale:  Although noninvasive ventilation (NIV) may prevent reintubation in patients at high risk of extubation failure in ICUs, this oxygenation strategy has not been specifically assessed in obese patients.  Objectives:  We hypothesized that NIV may decrease the risk of reintubation in obese patients compared with high-flow nasal oxygen.  Methods:   Post hoc  analysis of a multicenter randomized controlled trial (not prespecified) comparing NIV alternating with high-flow nasal oxygen versus high-flow nasal oxygen alone after extubation, with the aim of assessing NIV effects according to patient body mass index (BMI).  Measurements and Main Results:  Among 623 patients at high risk of extubation failure, 206 (33%) were obese (BMI ⩾ 30 kg/m 2 ), 204 (33%) were overweight (25 kg/m 2  ⩽ BMI < 30 kg/m 2 ), and 213 (34%) were normal or underweight (BMI < 25 kg/m 2 ). Significant heterogeneity of NIV effects on the rate of reintubation was found according to BMI ( P interaction  = 0.007). Reintubation rates at Day 7 were significantly lower with NIV alternating with high-flow nasal oxygen than with high-flow nasal oxygen alone in obese or overweight patients: 7% (15/204) versus 20% (41/206) (difference, -13% [95% confidence interval, -19 to -6];  P  = 0.0002), whereas it did not significantly differ in normal or underweight patients. In-ICU mortality was significantly lower with NIV than with high-flow nasal oxygen alone in obese or overweight patients (2% vs. 9%; difference, -6% [95% confidence interval, -11 to -2];  P  = 0.006).  Conclusions:  Prophylactic NIV alternating with high-flow nasal oxygen immediately after extubation significantly decreased the risk of reintubation and death compared with high-flow nasal oxygen alone in obese or overweight patients at high risk of extubation failure. By contrast, NIV was not effective in normal or underweight patients. Clinical trial registered with www.clinicaltrials.gov (NCT03121482).",2022,"Reintubation rates at day 7 were significantly lower with NIV alternating with HFNO than with HFNO alone in obese or overweight patients: 7% (15/204) vs. 20% (41/206); difference, -13%; [95% CI, -19 to -6]; P=0.0002; whereas it did not significantly differ in normal or underweight patients.","['623 patients at high-risk of extubation failure, 206 (33%) were obese (BMI≥30 kg/m2), 204 (33%) were overweight (25≤BMI<30), and 213 (34%) were normal or underweight (BMI<25', 'obese patients', 'Obese or Overweight Patients ']","['Non-Invasive Ventilation', 'HFNO', 'invasive ventilation (NIV', 'HFNO alone', 'NIV alternating with HFNO versus HFNO alone']","['Reintubation rates', 'ICU mortality', 'risk of reintubation', 'risk of reintubation and death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}]","[{'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}]","[{'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",623.0,0.118557,"Reintubation rates at day 7 were significantly lower with NIV alternating with HFNO than with HFNO alone in obese or overweight patients: 7% (15/204) vs. 20% (41/206); difference, -13%; [95% CI, -19 to -6]; P=0.0002; whereas it did not significantly differ in normal or underweight patients.","[{'ForeName': 'Arnaud W', 'Initials': 'AW', 'LastName': 'Thille', 'Affiliation': 'Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France.'}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Coudroy', 'Affiliation': 'Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France.'}, {'ForeName': 'Mai-Anh', 'Initials': 'MA', 'LastName': 'Nay', 'Affiliation': ""Centre Hospitalier Régional d'Orléans, Médecine Intensive Réanimation, Orléans, France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Gacouin', 'Affiliation': 'Centre Hospitalier Universitaire de Rennes, Service des Maladies Infectieuses et Réanimation Médicale, Hôpital Ponchaillou, Rennes, France.'}, {'ForeName': 'Maxens', 'Initials': 'M', 'LastName': 'Decavèle', 'Affiliation': 'Service de Pneumologie, Médecine Intensive et Réanimation (Département R3S), Hôpital Pitié-Salpêtrière, AP-HP 6-Sorbonne, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Paris, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Sonneville', 'Affiliation': 'Hôpital Bichat-Claude Bernard, Médecine Intensive Réanimation, AP-HP, Université Paris Diderot, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Beloncle', 'Affiliation': ""Centre Hospitalier Universitaire d'Angers, Département de Médecine Intensive Réanimation, Université d'Angers, Angers, France.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Girault', 'Affiliation': 'Normandie University, UNIROUEN, EA 3830, Medical Intensive Care Unit, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Dangers', 'Affiliation': 'Service de Réanimation Polyvalente, Centre Hospitalier Universitaire Félix Guyon, Saint Denis de la Réunion, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lautrette', 'Affiliation': 'Centre Hospitalier Universitaire de Clermont-Ferrand, Service de Réanimation Médicale, Hôpital Gabriel Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Levrat', 'Affiliation': 'Service de Réanimation, Centre Hospitalier de La Rochelle, La Rochelle, France.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Rouzé', 'Affiliation': 'Centre Hospitalier Universitaire de Lille, Centre de Réanimation, Université de Lille, Lille, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Vivier', 'Affiliation': 'Hôpital Saint-Joseph Saint-Luc, Réanimation Polyvalente, Lyon, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': 'Centre Hospitalier Universitaire de Nantes, Médecine Intensive Réanimation, Nantes, France.'}, {'ForeName': 'Jean-Damien', 'Initials': 'JD', 'LastName': 'Ricard', 'Affiliation': 'Service de Médecine Intensive Réanimation, Hôpital Louis Mourier, DMU ESPRIT, AP-HP, Colombes, France.'}, {'ForeName': 'Armand', 'Initials': 'A', 'LastName': 'Mekontso-Dessap', 'Affiliation': 'AP-HP, Hôpitaux Universitaires Henri Mondor, Service de Médecine Intensive Réanimation, Université Paris Est Créteil, Groupe de Recherche Clinique CARMAS, Créteil, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Barberet', 'Affiliation': 'Service de Réanimation Médicale, Groupe Hospitalier Régional Mulhouse Sud Alsace, site Emile Muller, Mulhouse, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lebert', 'Affiliation': 'Service de Médecine Intensive Réanimation, Centre Hospitalier Départemental de Vendée, La Roche Sur Yon, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': ""Centre Hospitalier Régional Universitaire de Tours, Médecine Intensive Réanimation, CIC 1415, Réseau CRICS-Trigger SEP, Centre d'étude des Pathologies Respiratoires, INSERM U1100, Université de Tours, Tours, France.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Massri', 'Affiliation': 'Service de Réanimation, Centre Hospitalier de Pau, Pau, France.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bourenne', 'Affiliation': 'Centre Hospitalier Universitaire La Timone 2, Médecine Intensive Réanimation, Réanimation des Urgences, Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'Gael', 'Initials': 'G', 'LastName': 'Pradel', 'Affiliation': ""Service de Réanimation, Centre Hospitalier Henri Mondor d'Aurillac, Aurillac, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bailly', 'Affiliation': 'Centre Hospitalier Universitaire de Brest, Médecine Intensive Réanimation, Brest, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Terzi', 'Affiliation': 'Centre Hospitalier Universitaire Grenoble Alpes, Médecine Intensive Réanimation, INSERM, Université Grenoble-Alpes, U1042, HP2, Grenoble, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Dellamonica', 'Affiliation': ""Centre Hospitalier Universitaire de Nice, Médecine Intensive Réanimation, Archet 1, UR2CA, Université Cote d'Azur, Nice, France; and.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lacave', 'Affiliation': 'Service de Réanimation Médico-Chirurgicale, Centre Hospitalier de Versailles, Le Chesnay, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Robert', 'Affiliation': 'Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': 'Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Ragot', 'Affiliation': ""Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202106-1452OC']
1340,34842573,Is Selenium Supplementation Beneficial in Acute Ischemic Stroke?,"BACKGROUND


Selenium (Se) plays a significant role in brain physiology. The existing human data demonstrate that stroke is associated with significantly reduced Se levels and glutathione peroxidase (GPx) activity. This study proposed to investigate the effect of intravenous Se (Selenase) administration in patients with acute ischemic stroke (AIS) on neurological outcomes, antioxidant enzyme activity, and inflammatory marker levels.
METHODS


AIS patients (n=50) were recruited from a neurology unit of a university-affiliated hospital. Patients were randomly assigned to receive either Selenase or placebo (saline) for 5 days. The modified ranking scale, the national institute of health stroke scale, and the mini-mental state examination, as primary outcomes, and the serum GPx concentration, total antioxidant activity, and tumor necrosis factor-α levels, as secondary outcomes, were measured at the baseline and on day 30.
RESULTS


Eventually, 44 patients with AIS completed the intervention study. A notable increase in GPx and total antioxidant activity levels was detected in the treatment group compared with the placebo group (110.63±52.48 m/mL, 1.34±0.30 mmol/L, P<0.05), whereas the serum tumor necrosis factor-α level in the Selenase group was significantly lower than that of the placebo group (58.58±61.33 pg/mL, P<0.05). In addition, Selenase improved the modified ranking scale and national institute of health stroke scale scores significantly (P<0.05 and <0.04, respectively), but no statistical difference was observed between the 2 groups in the mini-mental state examination score.
CONCLUSION


Selenase, plausibly due to its antioxidant function, results in positive outcomes in terms of neurological deficits, antioxidant enzyme activity, and inflammatory marker levels.",2021,"A notable increase in GPx and total antioxidant activity levels was detected in the treatment group compared with the placebo group (110.63±52.48 m/mL, 1.34±0.30 mmol/L, P<0.05), whereas the serum tumor necrosis factor-α level in the Selenase group was significantly lower than that of the placebo group (58.58±61.33 pg/mL, P<0.05).","['patients with acute ischemic stroke (AIS', '44 patients with AIS completed the intervention study', 'AIS patients (n=50) were recruited from a neurology unit of a university-affiliated hospital']","['Selenase or placebo (saline', 'placebo', 'intravenous Se (Selenase) administration']","['modified ranking scale and national institute of health stroke scale scores', 'serum GPx concentration, total antioxidant activity, and tumor necrosis factor-α levels', 'GPx and total antioxidant activity levels', 'serum tumor necrosis factor-α level', 'neurological outcomes, antioxidant enzyme activity, and inflammatory marker levels', 'Se levels and glutathione peroxidase (GPx) activity', 'modified ranking scale, the national institute of health stroke scale, and the mini-mental state examination', 'neurological deficits, antioxidant enzyme activity, and inflammatory marker levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0699794', 'cui_str': 'Rank'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0373721', 'cui_str': 'Selenium measurement'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}]",44.0,0.207538,"A notable increase in GPx and total antioxidant activity levels was detected in the treatment group compared with the placebo group (110.63±52.48 m/mL, 1.34±0.30 mmol/L, P<0.05), whereas the serum tumor necrosis factor-α level in the Selenase group was significantly lower than that of the placebo group (58.58±61.33 pg/mL, P<0.05).","[{'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Ramezani', 'Affiliation': 'Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Simani', 'Affiliation': 'Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Abedi', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Pakdaman', 'Affiliation': 'Brain Mapping Research Center, Shahid Beheshti University of Medical Sciences.'}]",The neurologist,['10.1097/NRL.0000000000000365']
1341,34844978,"A Randomized Trial of Fulvestrant, Everolimus, and Anastrozole for the Front-line Treatment of Patients with Advanced Hormone Receptor-positive Breast Cancer, SWOG S1222.","PURPOSE


Metastatic hormone receptor (HR)-positive, HER2-negative breast cancer is an important cause of cancer mortality. Endocrine treatment with or without additional targeted therapies has been the mainstay of treatment. This trial was designed to evaluate the combination of fulvestrant plus everolimus versus fulvestrant, everolimus, and anastrozole compared with fulvestrant alone in the first-line treatment of advanced HR-positive, HER2-negative breast cancer.
PATIENTS AND METHODS


This randomized placebo-controlled trial included postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had received no prior systemic therapy for metastatic disease. Participants were randomized to one of three treatment arms and the primary outcome was progression-free survival (PFS), comparing combinations of fulvestrant and everolimus with or without anastrozole with fulvestrant alone. Circulating tumor cells (CTC), as measured with two different methods, and circulating tumor DNA (ctDNA) were evaluated serially prior to treatment and the beginning of the second cycle of therapy.
RESULTS


Due in part to changes in clinical practice, the study was closed after accruing only 37 participants. There was no evidence that everolimus-containing combination treatment improved PFS or overall survival relative to fulvestrant alone. When modeled continuously, an association was observed of baseline CTC and ctDNA with poorer survival.
CONCLUSIONS


Although power of the study was limited, the findings were unable to support the routine use of everolimus combination endocrine therapy in the first-line treatment of advanced hormone-sensitive breast cancer. Prognostic impact of baseline ctDNA and copy-number variations in CTC was demonstrated.",2022,There was no evidence that everolimus-containing combination treatment improved PFS or overall survival relative to fulvestrant alone.,"['patients with advanced hormone receptor-positive breast cancer, SWOG S1222', 'advanced HR-positive, HER2-negative breast cancer', '37 participants', 'postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had received no prior systemic therapy for metastatic disease', 'advanced hormone-sensitive breast cancer']","['fulvestrant alone', 'everolimus combination endocrine therapy', 'fulvestrant plus everolimus versus fulvestrant, everolimus and anastrozole', 'fulvestrant and everolimus with or without anastrozole to fulvestrant alone', 'placebo', 'fulvestrant, everolimus and anastrozole']","['Circulating tumor cells (CTC', 'PFS or overall survival', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.442548,There was no evidence that everolimus-containing combination treatment improved PFS or overall survival relative to fulvestrant alone.,"[{'ForeName': 'Halle C F', 'Initials': 'HCF', 'LastName': 'Moore', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Barlow', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, Washington.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Somlo', 'Affiliation': 'City of Hope Medical Center, Duarte, California.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'University of Washington School of Medicine/Seattle Cancer Care Alliance, Seattle, Washington.'}, {'ForeName': 'Anne F', 'Initials': 'AF', 'LastName': 'Schott', 'Affiliation': 'University of Michigan Rogel Cancer Center, Ann Arbor, Michigan.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'University of Michigan Rogel Cancer Center, Ann Arbor, Michigan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kuhn', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Hicks', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Welter', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Dy', 'Affiliation': 'Crossroads Cancer Center (Cancer Care Specialists of Illinois), Heartland NCORP, Decatur, Illinois.'}, {'ForeName': 'Christina H', 'Initials': 'CH', 'LastName': 'Yeon', 'Affiliation': 'City of Hope, South Pasadena Cancer Center, South Pasadena, California.'}, {'ForeName': 'Alison K', 'Initials': 'AK', 'LastName': 'Conlin', 'Affiliation': 'Pacific Cancer Research ConsortiumNCORP, Portland, Oregon.'}, {'ForeName': 'Ernie', 'Initials': 'E', 'LastName': 'Balcueva', 'Affiliation': ""Michigan CRC NCORP, St. Mary's of Michigan, Saginaw, Michigan.""}, {'ForeName': 'Danika L', 'Initials': 'DL', 'LastName': 'Lew', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, Washington.'}, {'ForeName': 'Debasish', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Pusztai', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-3131']
1342,34845002,Two-year efficacy and safety of erenumab in participants with episodic migraine and 2-4 prior preventive treatment failures: results from the LIBERTY study.,"OBJECTIVE


To evaluate individual and group long-term efficacy and safety of erenumab in individuals with episodic migraine (EM) for whom 2-4 prior preventatives had failed.
METHODS


Participants completing the 12-week double-blind treatment phase (DBTP) of the LIBERTY study could continue into an open-label extension phase (OLEP) receiving erenumab 140 mg monthly for up to 3 years. Main outcomes assessed at week 112 were: ≥50%, ≥75% and 100% reduction in monthly migraine days (MMD) as group responder rate and individual responder rates, MMD change from baseline, safety and tolerability.
RESULTS


Overall 240/246 (97.6%) entered the OLEP (118 continuing erenumab, 122 switching from placebo). In total 181/240 (75.4%) reached 112 weeks, 24.6% discontinued, mainly due to lack of efficacy (44.0%), participant decision (37.0%) and adverse events (AEs; 12.0%). The ≥50% responder rate was 57.2% (99/173) at 112 weeks. Of ≥50% responders at the end of the DBTP, 36/52 (69.2%) remained responders at ≥50% and 22/52 (42.3%) at >80% of visits. Of the non-responders at the end of the DBTP, 60/185 (32.4%) converted to ≥50% responders in at least half the visits and 24/185 (13.0%) converted to ≥50% responders in >80% of visits. Change from baseline at 112 weeks in mean (SD) MMD was -4.2 (5.0) days. Common AEs (≥10%) were nasopharyngitis, influenza and back pain.
CONCLUSIONS


Efficacy was sustained over 112 weeks in individuals with difficult-to-treat EM for whom 2-4 prior migraine preventives had failed. Erenumab treatment was safe and well tolerated, in-line with previous studies.
TRIAL REGISTRATION NUMBER


NCT03096834.",2022,"In total 181/240 (75.4%) reached 112 weeks, 24.6% discontinued, mainly due to lack of efficacy (44.0%), participant decision (37.0%) and adverse events (AEs; 12.0%).","['Participants completing the 12-week', 'participants with episodic migraine and 2-4 prior preventive treatment failures', 'individuals with episodic migraine (EM) for whom 2-4 prior preventatives had failed']","['erenumab', 'double-blind treatment phase (DBTP) of the LIBERTY study could continue into an open-label extension phase (OLEP) receiving erenumab 140\u2009mg monthly for up to 3 years', 'OLEP']","['adverse events', 'nasopharyngitis, influenza and back pain', 'safe and well tolerated', 'monthly migraine days (MMD) as group responder rate and individual responder rates, MMD change from baseline, safety and tolerability', 'responder rate']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.379074,"In total 181/240 (75.4%) reached 112 weeks, 24.6% discontinued, mainly due to lack of efficacy (44.0%), participant decision (37.0%) and adverse events (AEs; 12.0%).","[{'ForeName': 'Michel Dominique', 'Initials': 'MD', 'LastName': 'Ferrari', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, 2300 RC Leiden, Netherlands m.d.ferrari@lumc.nl.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charite Universitatsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK.""}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Paiva da Silva Lima', 'Affiliation': 'Amgen Inc, Thousand Oaks, California, USA.'}, {'ForeName': 'Subhayan', 'Initials': 'S', 'LastName': 'Mondal', 'Affiliation': 'Biostatistics and Pharmacometrics, Novartis Healthcare Pvt Ltd, Hyderabad, India.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Novartis Pharmaceuticals Corp, East Hanover, New Jersey, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Tenenbaum', 'Affiliation': 'Novartis Pharmaceuticals Corp, East Hanover, New Jersey, USA.'}, {'ForeName': 'Shaloo', 'Initials': 'S', 'LastName': 'Pandhi', 'Affiliation': 'Novartis Pharma AG, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lanteri-Minet', 'Affiliation': 'Pain Department and FHU InovPain, Centre Hospitalier Universitaire de Nice, Nice, France.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Stites', 'Affiliation': 'Novartis Pharmaceuticals Corp, East Hanover, New Jersey, USA.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2021-327480']
1343,34849957,Evaluation of the effect of sofosbuvir and daclatasvir in hospitalized COVID-19 patients: a randomized double-blind clinical trial (DISCOVER).,"BACKGROUND


The combination of sofosbuvir and daclatasvir has shown preliminary efficacy for hospitalized patients with COVID-19 in four open-label studies with small sample sizes. This larger trial aimed to assess if the addition of sofosbuvir/daclatasvir to standard care improved clinical outcomes in hospitalized patients with COVID-19.
METHODS


This was a placebo-controlled, double-blind, randomized clinical trial in adults hospitalized with COVID-19 at 19 hospitals in Iran. Patients were randomized to oral sofosbuvir/daclatasvir 400/60 mg once-daily or placebo in addition to standard of care. Patients were included if they had positive PCR or diagnostic chest CT, O2 saturation <95% and compatible symptoms. The primary outcome was hospital discharge within 10 days of randomization. Secondary outcomes included mortality and time to clinical events. The trial is registered on the Iran Registry of Clinical Trials under IRCT20200624047908N1.
RESULTS


Between July and October 2020, 1083 patients were randomized to either the sofosbuvir/daclatasvir arm (n = 541) or the placebo arm (n = 542). No significant difference was observed in the primary outcome of hospital discharge within 10 days, which was achieved by 415/541 (77%) in the sofosbuvir/daclatasvir arm and 411/542 (76%) in the placebo arm [risk ratio (RR) 1.01, 95% CI 0.95-1.08, P = 0.734]. In-hospital mortality was 60/541 (11%) in the sofosbuvir/daclatasvir arm versus 55/542 (10%) in the placebo arm (RR 1.09, 95% CI 0.77-1.54, P = 0.615). No differences were observed in time to hospital discharge or time to in-hospital mortality.
CONCLUSIONS


We observed no significant effect of sofosbuvir/daclatasvir versus placebo on hospital discharge or survival in hospitalized COVID-19 patients.",2022,"No significant difference was observed in the primary outcome of hospital discharge within 10 days, which was achieved by 415/541 (77%) in the sofosbuvir/daclatasvir arm and 411/542 (76%) in the placebo arm [risk ratio (RR) 1.01, 95% CI 0.95-1.08, P = 0.734].","['hospitalized patients with COVID-19 in four open-label studies with small sample sizes', 'adults hospitalized with COVID-19 at 19 hospitals in Iran', 'hospitalized COVID-19 patients', 'hospitalized patients with COVID-19', 'Between July and October 2020, 1083 patients']","['oral sofosbuvir/daclatasvir 400/60 mg once-daily or placebo', 'sofosbuvir and daclatasvir', 'placebo', 'sofosbuvir/daclatasvir']","['mortality and time to clinical events', 'hospital discharge', 'hospital mortality', 'hospital discharge within 10 days of randomization', 'positive PCR or diagnostic chest CT, O2 saturation', 'hospital discharge or survival', 'time to hospital discharge or time to in-hospital mortality']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",1083.0,0.788399,"No significant difference was observed in the primary outcome of hospital discharge within 10 days, which was achieved by 415/541 (77%) in the sofosbuvir/daclatasvir arm and 411/542 (76%) in the placebo arm [risk ratio (RR) 1.01, 95% CI 0.95-1.08, P = 0.734].","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mobarak', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Salasi', 'Affiliation': 'Imam Khomeini Hospital of Abadan Petroleum Health Organization, Abadan, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Hormati', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Khodadadi', 'Affiliation': 'Infectious Disease Department, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Ziaee', 'Affiliation': 'Infectious Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Abedi', 'Affiliation': 'Infectious Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Ebrahimzadeh', 'Affiliation': 'Infectious Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Azarkar', 'Affiliation': 'Infectious Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Mansour-Ghanaei', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Joukar', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Yeganeh', 'Affiliation': 'Caspian Digestive Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Tofigh', 'Initials': 'T', 'LastName': 'Yaghubi Kalurazi', 'Affiliation': 'Department of Health, Nutrition & Infectious Diseases, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Naghipour', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Mehrabi', 'Affiliation': 'Department of Infectious Diseases, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Amir Reza', 'Initials': 'AR', 'LastName': 'Bahadori', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shoeleh', 'Initials': 'S', 'LastName': 'Yaghoubi', 'Affiliation': 'Department of Infectious Diseases, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Rohollah', 'Initials': 'R', 'LastName': 'Moslemi', 'Affiliation': 'Department of Clinical Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Abbaspour Kasgari', 'Affiliation': 'Department of Clinical Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Hafez', 'Initials': 'H', 'LastName': 'Fakheri', 'Affiliation': 'Gut and Liver Research Center, Non-communicable Disease Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Minoo', 'Initials': 'M', 'LastName': 'Moghimi', 'Affiliation': 'Department of Clinical Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Amir Mohammad', 'Initials': 'AM', 'LastName': 'Shabani', 'Affiliation': 'Department of Clinical Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Nekoukar', 'Affiliation': 'Department of Clinical Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Farhang', 'Initials': 'F', 'LastName': 'Babamahmoodi', 'Affiliation': 'Antimicrobial Resistance Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Davoudi Badabi', 'Affiliation': 'Antimicrobial Resistance Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Lotfollah', 'Initials': 'L', 'LastName': 'Davoodi', 'Affiliation': 'Antimicrobial Resistance Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hassaniazad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Barahimi', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Abdolali', 'Initials': 'A', 'LastName': 'Tousi', 'Affiliation': 'Student Research Committee, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadiseh', 'Initials': 'H', 'LastName': 'Hosamirudsari', 'Affiliation': 'Infectious Diseases Department, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ali Asgari', 'Affiliation': 'Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abdollahi', 'Affiliation': 'Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Anushiravani', 'Affiliation': 'Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Minoosh', 'Initials': 'M', 'LastName': 'Shabani', 'Affiliation': 'Department of Infectious Diseases and Tropical Medicine, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Shokouhi', 'Affiliation': 'Department of Infectious Diseases and Tropical Medicine, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Khajavirad', 'Affiliation': 'Department of Internal Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Infectious Diseases Department, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Ali', 'Initials': 'SA', 'LastName': 'Dehghan Manshadi', 'Affiliation': 'Infectious Diseases Department, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hashem', 'Initials': 'H', 'LastName': 'Mousavi', 'Affiliation': 'Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Zolfaghari', 'Affiliation': 'Student Research Committee, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Azimi', 'Affiliation': 'Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Zeinali', 'Affiliation': 'Department of Cardiology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Akbarpour', 'Affiliation': 'Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Dorsa', 'Initials': 'D', 'LastName': 'Merat', 'Affiliation': 'Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Gholamali', 'Initials': 'G', 'LastName': 'Eslami', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Sajedeh', 'Initials': 'S', 'LastName': 'Mousaviasl', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sayar', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Radmanesh', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Ebrahimzadeh', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Arizavi', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Jelvay', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Shokrollah', 'Initials': 'S', 'LastName': 'Salmanzadeh', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Esmaeilian', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Mobarak', 'Affiliation': 'Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Karimi', 'Affiliation': 'Department of Infectious Disease, Fasa University of Medical Sciences, Fasa, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Poormontaseri', 'Affiliation': 'Department of Infectious Disease, Fasa University of Medical Sciences, Fasa, Iran.'}, {'ForeName': 'Nasrollah', 'Initials': 'N', 'LastName': 'Hasooni Bahrini', 'Affiliation': 'Imam Khomeini Hospital of Abadan Petroleum Health Organization, Abadan, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Bonyadi', 'Affiliation': 'Imam Khomeini Hospital of Abadan Petroleum Health Organization, Abadan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Dehghani', 'Affiliation': 'Imam Khomeini Hospital of Abadan Petroleum Health Organization, Abadan, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Mirzaei', 'Affiliation': 'Department of Biotechnology, School of Medicine, Zabol University of Medical Sciences, Zabol, Iran.'}, {'ForeName': 'Masoome', 'Initials': 'M', 'LastName': 'Noori Jangi', 'Affiliation': 'Department of Infectious Diseases, School of Medicine, Zabol University of Medical Sciences, Zabol, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Pourmasoomi', 'Affiliation': 'Department of Infectious Diseases, School of Medicine, Zabol University of Medical Sciences, Zabol, Iran.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Rezaie Keikhaie', 'Affiliation': 'Department of Infectious Diseases, School of Medicine, Zabol University of Medical Sciences, Zabol, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Afshari', 'Affiliation': 'Pediatric Gastroenterology and Hepatology Research Center, Zabol University of Medical Sciences, Zabol, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Nateghi Baygi', 'Affiliation': 'Research and Development Department, Fanavaran Rojan Mohaghegh Darou Co., Tehran, Iran.'}, {'ForeName': 'Helia', 'Initials': 'H', 'LastName': 'Nateghi Baygi', 'Affiliation': 'Research and Development Department, Fanavaran Rojan Mohaghegh Darou Co., Tehran, Iran.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Levi', 'Affiliation': 'Department of Intensive Care, University College London Hospital, London, UK.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'McCann', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wentzel', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Department of Infectious Diseases, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': 'Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkab433']
1344,34853107,Primary care physician involvement during hospitalisation: a qualitative analysis of perspectives from frequently hospitalised patients.,"OBJECTIVE


To explore frequently hospitalised patients' experiences and preferences related to primary care physician (PCP) involvement during hospitalisation across two care models.
DESIGN


Qualitative study embedded within a randomised controlled trial. Semistructured interviews were conducted with patients. Transcripts were analysed using qualitative template analysis.
SETTING


In the Comprehensive Care Programme (CCP) Study, in Illinois, USA, Medicare patients at increased risk of hospitalisation are randomly assigned to: (1) care by a CCP physician who serves as a PCP across both inpatient and outpatient settings or (2) care by a PCP as outpatient and by hospitalists as inpatients (standard care).
PARTICIPANTS


Twelve standard care and 12 CCP patients were interviewed.
RESULTS


Themes included: (1) Positive attitude towards PCP; (2) Longitudinal continuity with PCP valued; (3) Patient preference for PCP involvement in hospital care; (4) Potential for in-depth involvement of PCP during hospitalisation often unrealised (involvement rare in standard care; in CCP, frequent interaction with PCP fostered patient involvement in decision making); and (5) PCP collaboration with hospital-based providers frequently absent (no interaction for standard care patients; CCP patients emphasising PCP's role in interdisciplinary coordination).
CONCLUSION


Frequently hospitalised patients value PCP involvement in the hospital setting. CCP patients highlighted how an established relationship with their PCP improved interdisciplinary coordination and engagement with decision making. Inpatient-outpatient relational continuity may be an important component of programmes for frequently hospitalised patients. Opportunities for enhancing PCP involvement during hospitalisation should be considered.",2021,"RESULTS


Themes included: (1) Positive attitude towards PCP; (2) Longitudinal continuity with PCP valued; (3) Patient preference for PCP involvement in hospital care; (4) Potential for in-depth involvement of PCP during hospitalisation often unrealised (involvement rare in standard care; in CCP, frequent interaction with PCP fostered patient involvement in decision making); and (5) PCP collaboration with hospital-based providers frequently absent (no interaction for standard care patients; CCP patients emphasising PCP's role in interdisciplinary coordination).
","[""hospitalised patients' experiences and preferences related to primary care physician (PCP) involvement during hospitalisation across two care models"", 'Illinois, USA, Medicare patients at increased risk of hospitalisation are randomly assigned to: (1) care by a CCP physician who serves as a PCP across both inpatient and outpatient settings or (2) care by a PCP as outpatient and by hospitalists as inpatients (standard care', 'CCP patients', 'frequently hospitalised patients', 'Twelve standard care and 12 CCP patients were interviewed']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0600620', 'cui_str': 'Hospitalist'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]",[],[],,0.0695559,"RESULTS


Themes included: (1) Positive attitude towards PCP; (2) Longitudinal continuity with PCP valued; (3) Patient preference for PCP involvement in hospital care; (4) Potential for in-depth involvement of PCP during hospitalisation often unrealised (involvement rare in standard care; in CCP, frequent interaction with PCP fostered patient involvement in decision making); and (5) PCP collaboration with hospital-based providers frequently absent (no interaction for standard care patients; CCP patients emphasising PCP's role in interdisciplinary coordination).
","[{'ForeName': 'Erin Yildirim', 'Initials': 'EY', 'LastName': 'Rieger', 'Affiliation': 'Pritzker School of Medicine, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Josef N S', 'Initials': 'JNS', 'LastName': 'Kushner', 'Affiliation': 'Department of Medicine, Lenox Hill Hospital, New York City, New York, USA.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Sriram', 'Affiliation': 'School of Population and Public Health, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Abbie', 'Initials': 'A', 'LastName': 'Klein', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Lauren O', 'Initials': 'LO', 'LastName': 'Wiklund', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Meltzer', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Joyce W', 'Initials': 'JW', 'LastName': 'Tang', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Illinois, USA jtang@bsd.uchicago.edu.'}]",BMJ open,['10.1136/bmjopen-2021-053784']
1345,34800351,"Authors reply re: Modification of oxytocin use through a coaching-based intervention based on the WHO Safe Childbirth Checklist in Uttar Pradesh, India: a secondary analysis of a cluster randomised controlled trial.",,2022,,[],['oxytocin'],[],[],"[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",[],,0.168404,,"[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Marx Delaney', 'Affiliation': ""Ariadne Labs, A Joint center of Harvard T.H. Chan School of Public Health and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Community Empowerment Lab, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Katherine Ea', 'Initials': 'KE', 'LastName': 'Semrau', 'Affiliation': ""Ariadne Labs, A Joint center of Harvard T.H. Chan School of Public Health and Brigham and Women's Hospital, Boston, MA, USA.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.17004']
1346,34800700,CCTG BR34: A Randomized Phase 2 Trial of Durvalumab and Tremelimumab With or Without Platinum-Based Chemotherapy in Patients With Metastatic NSCLC.,"INTRODUCTION


First-line therapy for patients with metastatic NSCLC includes checkpoint inhibitor monotherapy, dual checkpoint inhibition, or combination with chemotherapy. We compared outcomes with combination chemoimmunotherapy versus dual checkpoint inhibition as first-line treatment for patients with metastatic NSCLC.
METHODS


This open-label, randomized clinical trial was conducted at 44 sites in Canada and Australia. Patients with treatment-naive, metastatic NSCLC without sensitizing EGFR or ALK alterations were randomized (1:1) to receive treatment with durvalumab plus tremelimumab with or without platinum-doublet chemotherapy. The primary end point was overall survival (OS). Secondary end points were progression-free survival, overall response rate, and safety.
RESULTS


A total of 301 patients were randomized. Median OS was 16.6 months (95% confidence interval [CI]: 12.6-19.1) with chemotherapy plus immunotherapy and 14.1 months (95% CI: 10.6-18.3) with immunotherapy (hazard ratio = 0.88, 90% CI: 0.67-1.16, p = 0.46). Median progression-free survival with chemotherapy plus immunotherapy was 7.7 months (95% CI: 5.5-8.5) and 3.2 months (95% CI: 2.7-5.1) with immunotherapy (hazard ratio = 0.67, 95% CI: 0.52-0.88). The overall response rate with chemoimmunotherapy was 42.4% and 29.3% with immunotherapy (adjusted OR = 1.69, 95% CI: 1.04-2.76). The percentage of patients with grade 3 or higher adverse events was 82% in the chemotherapy plus immunotherapy group and 70% in the immunotherapy group. Exploratory analyses of programmed death-ligand 1 expression and blood-based tumor mutation burden revealed no differential treatment effect on OS.
CONCLUSIONS


The addition of chemotherapy to durvalumab plus tremelimumab in the first-line treatment of stage IV NSCLC did not improve survival compared with durvalumab plus tremelimumab alone. Further study is warranted to identify patients that benefit from initial immunotherapy alone versus combination chemotherapy plus immunotherapy as first-line treatment.",2022,"Median PFS with chemotherapy plus immunotherapy was 7.7 months (95%CI, 5.5-8.5) and 3.2 months (95%CI, 2.7-5.1) with immunotherapy, (HR 0.67, 95%CI, 0.52-0.88).","['301 patients were randomized', 'patients with metastatic NSCLC', 'Patients with treatment-naïve, metastatic NSCLC without sensitizing EGFR or ALK alterations', '44 sites in Canada and Australia', 'patients with metastatic non-small cell lung cancer']","['chemotherapy plus immunotherapy', 'platinum-based chemotherapy', 'immunotherapy alone versus combination chemotherapy plus immunotherapy', 'durvalumab plus tremelimumab with or without platinum doublet chemotherapy', 'combination chemo-immunotherapy versus dual checkpoint inhibition', 'CCTG BR34', 'durvalumab and tremelimumab ']","['overall survival (OS', 'survival', 'Median PFS', 'percentage of patients with grade ≥3 adverse events', 'progression-free survival (PFS), overall response rate (ORR) and safety', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",301.0,0.27461,"Median PFS with chemotherapy plus immunotherapy was 7.7 months (95%CI, 5.5-8.5) and 3.2 months (95%CI, 2.7-5.1) with immunotherapy, (HR 0.67, 95%CI, 0.52-0.88).","[{'ForeName': 'Natasha B', 'Initials': 'NB', 'LastName': 'Leighl', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada; Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada. Electronic address: Natasha.Leighl@uhn.ca.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Laurie', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada; The Ottawa Hospital Cancer Centre and Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Glenwood D', 'Initials': 'GD', 'LastName': 'Goss', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada; The Ottawa Hospital Cancer Centre and Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Brett G M', 'Initials': 'BGM', 'LastName': 'Hughes', 'Affiliation': 'Australasian Lung Cancer Trials Group, Milton, Australia; Prince Charles Hospital, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Stockler', 'Affiliation': 'Australasian Lung Cancer Trials Group, Milton, Australia; National Health and Medical Research Council (NHMRC) Clinical Trials Centre, Sydney, Australia.'}, {'ForeName': 'Ming-Sound', 'Initials': 'MS', 'LastName': 'Tsao', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada; Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Hwang', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada; Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Phillipe', 'Initials': 'P', 'LastName': 'Joubert', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada; Institut Universitaire de Cardiologie et de Pneumologie de Québec, Laval, Québec, Canada.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Kulkarni', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada; Windsor Regional Hospital, Windsor, Ontario, Canada.'}, {'ForeName': 'Normand', 'Initials': 'N', 'LastName': 'Blais', 'Affiliation': ""Canadian Cancer Trials Group, Kingston, Ontario, Canada; Centre hospitalier de l'Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'Anil A', 'Initials': 'AA', 'LastName': 'Joy', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada; Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Mates', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada; Kingston General Hospital, Kingston, Ontario, Canada.'}, {'ForeName': 'Punam', 'Initials': 'P', 'LastName': 'Rana', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada; Humber River Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Yadav', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada; Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Underhill', 'Affiliation': 'Australasian Lung Cancer Trials Group, Milton, Australia; Albury Wodonga Regional Cancer Centre, Albury, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada; BC Cancer, Surrey, British Columbia, Canada.'}, {'ForeName': 'Penelope A', 'Initials': 'PA', 'LastName': 'Bradbury', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada; Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hiltz', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Dancey', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada.'}, {'ForeName': 'Keyue', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Vera-Badillo', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2021.10.023']
1347,34803148,Perianal Application of Glyceryl Trinitrate Ointment Versus Tocopherol Acetate Ointment in the Treatment of Chronic Anal Fissure: A Randomized Clinical Trial.,"BACKGROUND


Medical treatment, including glyceryl trinitrate ointment, represents the first step for the management of chronic anal fissure. However, glyceryl trinitrate ointment is associated with headache and, consequently, a high withdrawal rate of the treatment.
OBJECTIVE


The aim of the present study was to evaluate the effect of the topical application of tocopherol acetate ointment on pain relief and chronic anal fissure epithelialization, comparing it with the effect of a standard treatment with glyceryl trinitrate ointment.
DESIGN


This is a 2-parallel-group, single-center, randomized controlled, intent-to-treat clinical trial.
SETTINGS


This study was conducted at the Garcilaso Clinic affiliated with Universidad Alfonso X (Madrid, Spain).
PATIENTS


Patients with chronic anal fissure were selected.
INTERVENTIONS


Patients were randomly assigned into 2 groups: patients receiving tocopherol acetate ointment and patients receiving glyceryl trinitrate ointment.
MAIN OUTCOME MEASURES


The primary end point was quantification of anal pain 8 weeks after beginning the treatment as measured by a Visual Analogue Scale ranging from 0 to 100 mm. The secondary end points were the healing rate (during the treatment period of 8 weeks) and the recurrence rate.
RESULTS


One hundred sixty consecutive patients were treated, 80 in each group. By 8 weeks after treatment, mean anal pain score declined by 56.2 mm in the glyceryl trinitrate ointment group compared with a mean anal pain score decline of 67.1 mm in the tocopherol acetate ointment group (mean difference, 10.9 mm (95% CI, 4.3-18.6); p = 0.018). Sixteen weeks after finishing the therapy, the recurrence rate was 13.2% in the glyceryl trinitrate ointment group vs 2.9 in the tocopherol acetate ointment group (p = 0.031).
LIMITATIONS


Limitations of the study include the absence of manometric measurements of the internal anal sphincter before and after the treatments and the use of glyceryl trinitrate ointment as an active comparator, whereas calcium channel blockers are actually the standard treatment.
CONCLUSIONS


Anal pain was significantly lower in the tocopherol acetate ointment group than in the glyceryl trinitrate ointment group at 8 weeks after treatment. Tocopherol acetate ointment achieved a greater healing rate and a lower recurrence rate 16 weeks after finishing the treatment. See Video Abstract at http://links.lww.com/DCR/B751.
REGISTRATION


URL: https://www.clinicaltrials.gov; Identifier: NCT03787030.APLICACIÓN PERIANAL DE POMADA DE TRINITRATO DE GLICERILO FRENTE A LA POMADA DE ACETATO DE TOCOFEROL EN EL TRATAMIENTO DE LA FISURA ANAL CRÓNICA: UN ENSAYO CLÍNICO ALEATORIZADOANTECEDENTES:El tratamiento médico, incluida la pomada de trinitrato de glicerilo, representa el primer paso para el tratamiento de la fisura anal crónica. Sin embargo, la pomada de trinitrato de glicerilo se asocia con cefalea y, en consecuencia, una alta tasa de cancelación del tratamiento.OBJETIVO:El objetivo del presente estudio fue evaluar el efecto de la aplicación tópica de pomada de acetato de tocoferol en el alivio del dolor y la epitelización de la fisura anal crónica, comparándolo con el efecto de un tratamiento estándar con pomada de trinitrato de glicerilo.DISEÑO:Ensayo clínico con intención de tratar controlado, aleatorizado, de un solo centro, con dos grupos paralelos.ESCENARIO:Clínica Garcilaso adscrita a la Universidad Alfonso X (Madrid, España).PACIENTES:Pacientes con fisura anal crónica.INTERVENCIONES:Los pacientes fueron aleatorizados en 2 grupos: pacientes que recibieron pomada de acetato de tocoferol y pacientes que recibieron pomada de trinitrato de glicerilo.PRINCIPALES MEDIDAS DE RESULTADO:El criterio de valoración principal fue la cuantificación del dolor anal 8 semanas después de comenzar el tratamiento, medido por la escala analógica visual que varía de 0 a 100 mm. Los criterios de valoración secundarios fueron la tasa de curación (durante el período de tratamiento de 8 semanas) y la tasa de recurrencia.RESULTADOS:Se trataron ciento sesenta pacientes consecutivos, 80 en cada grupo. A las ocho semanas después del tratamiento, la puntuación media de dolor anal se redujo en 56.2 mm en el grupo de pomada de trinitrato de glicerilo en comparación con una disminución de la puntuación de dolor anal medio de 67.1 mm en el grupo de pomada de acetato de tocoferol (diferencia media: 10.9 mm (intervalo de confianza del 95%; 4.3 a 18.6; p = 0.018) Dieciséis semanas después de finalizar la terapia, la tasa de recurrencia fue del 13.2% en el grupo de pomada de trinitrato de glicerilo frente a 2.9 en el grupo de pomada de acetato de tocoferol (p = 0.031).LIMITACIONES:Ausencia de medidas manométricas del esfínter anal interno antes y después de los tratamientos. Ungüento de trinitrato de glicerilo como comparador activo, mientras que los bloqueadores de los canales de calcio son en realidad el tratamiento estándar de oro.CONCLUSIONES:El dolor anal fue significativamente menor en el grupo de ungüento de acetato de tocoferol que en el grupo de ungüento de trinitrato de glicerilo a las 8 semanas después del tratamiento. La pomada de acetato de tocoferol logró una mayor tasa de curación y una menor tasa de recurrencia 16 semanas después de finalizar el tratamiento. Consulte Video Resumen en http://links.lww.com/DCR/B751. (Traducción-Dr. Jorge Silva Velazco).",2022,tocopherol acetate ointment achieved a greater healing rate and a lower recurrence rate 16 weeks after finishing the treatment.,"['One hundred sixty consecutive patients were treated, 80 in each group', 'Patients with chronic anal fissure', 'Chronic Anal Fissure', 'Garcilaso Clinic affiliated with Universidad Alfonso X (Madrid, Spain']","['glyceryl trinitrate ointment', 'Glyceryl Trinitrate Ointment', 'tocopherol acetate ointment', 'Glyceryl trinitrate ointment', 'Tocopheral Acetate Ointment']","['pain relief and chronic anal fissure epithelialization', 'quantification of anal pain', 'healing rate', 'mean anal pain score', 'Visual Analogue Scale', 'recurrence rate', 'therapy recurrence rate', 'mean anal pain score decline', 'Anal pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0349071', 'cui_str': 'Chronic anal fissure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0078373', 'cui_str': 'Tocopherol Acetate'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0349071', 'cui_str': 'Chronic anal fissure'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}, {'cui': 'C0238637', 'cui_str': 'Anal pain'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",160.0,0.0818319,tocopherol acetate ointment achieved a greater healing rate and a lower recurrence rate 16 weeks after finishing the treatment.,"[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Department of Surgery, Garcilaso Clinic, Madrid, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Llavero', 'Affiliation': ''}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000002120']
1348,34807249,Family Policy Awareness and Marital Intentions: A National Survey Experimental Study.,"Despite extensively examining the effects of family policies on marriage and fertility rates, previous research has paid little attention to the process of policy implementation and has implicitly assumed that individuals are fully aware of the policy information when making marital and fertility decisions. Challenging this assumption, we theorize policy awareness as an important mechanism for understanding the potential influence of family policies on individuals' marital intentions, an understudied yet crucial determinant of family formation behavior. In an experiment using a national survey of young unmarried individuals in Japan, respondents were randomly assigned to treatment and control groups. The treatment group was informed about 17 Japanese family policy benefits, but most of the respondents knew none or only a few of these benefits. After exposure to the policy information, the treatment group had significantly higher marital intentions than the control group, which had similar baseline characteristics but no information exposure. Crucially, such positive effects were particularly pronounced among high-educated women and high- and low-educated men, reflecting the differentiated effects of policy awareness under Japan's traditional gender role norms. Overall, these findings highlight the pivotal role of policy awareness during the family formation process and contribute to the debate over whether and how family policies may influence different subpopulations.",2022,"After exposure to the policy information, the treatment group had significantly higher marital intentions than the control group, which had similar baseline characteristics but no information exposure.","['young unmarried individuals in Japan, respondents', 'Family Policy Awareness and Marital Intentions']",[],['marital intentions'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0015606', 'cui_str': 'Family Policy'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",[],"[{'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",17.0,0.0348411,"After exposure to the policy information, the treatment group had significantly higher marital intentions than the control group, which had similar baseline characteristics but no information exposure.","[{'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Gong', 'Affiliation': 'Institute of Sociology, Chinese Academy of Social Sciences, Beijing, China.'}, {'ForeName': 'Senhu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Sociology, National University of Singapore, Singapore.'}]",Demography,['10.1215/00703370-9624150']
1349,34809904,Associations of Age at Marriage With Marital Decision-Making Agency Among Adolescent Wives in Rural Niger.,"PURPOSE


Child marriage is associated with multiple adverse health and social outcomes. Although evidence suggests that child marriage is associated with reduced participation in personal and household decisions for women, less is known about the association between age at marriage and decision-making among married adolescent girls. This study assesses associations between adolescents' age at marriage and two dimensions of decision-making (participation and satisfaction) in the high early marriage prevalence settings of Niger.
METHODS


Cross-sectional data from a cluster-randomized control trial of a community-level program to increase the use of modern contraceptives among married adolescents in the Dosso region of Niger were analyzed. Multiple logistic regression models were used to determine the association of age at marriage with married girls' participation in and satisfaction with decision-making processes.
RESULTS


More than half of married adolescents (N = 796) were married before reaching the age of 15 years. Older age at marriage was associated with adolescents' increased participation in decisions related to economics (adjusted odds ratio: 1.23; 95% confidence interval: 1.05-1.43) and health-care access (adjusted odds ratio: 1.18; 95% confidence interval: 1.01-1.40), but not with greater reported satisfaction with their control over these decisions.
CONCLUSIONS


The study suggests that marrying as a very young adolescent places girls in even more disadvantaged positions regarding decision-making. These findings indicate the need to design programs targeted at addressing inequitable gender norms to reduce early child marriage and increase participation in decision-making. Further study of satisfaction with participation in decision-making is recommended, including consideration of whether it is related to gender norms for participation in decisions rather than actual participation.",2021,"Older age at marriage was associated with adolescents' increased participation in decisions related to economics (adjusted odds ratio: 1.23; 95% confidence interval: 1.05-1.43) and health-care access (adjusted odds ratio: 1.18; 95% confidence interval: 1.01-1.40), but not with greater reported satisfaction with their control over these decisions.
","['Age at Marriage With Marital Decision-Making Agency', 'Adolescent Wives in Rural Niger', 'young adolescent places girls', 'married adolescents in the Dosso region of Niger were analyzed', 'married adolescents (N\xa0= 796) were married before reaching the age of 15\xa0years', 'married adolescent girls', ""adolescents' age at marriage and two dimensions of decision-making (participation and satisfaction) in the high early marriage prevalence settings of Niger""]","['modern contraceptives', 'community-level program']",['health-care access'],"[{'cui': 'C0024842', 'cui_str': 'Marriage Age'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0242665', 'cui_str': 'Wife'}, {'cui': 'C0028074', 'cui_str': 'Niger'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0018748', 'cui_str': 'Accessibility of Health Services'}]",796.0,0.0884033,"Older age at marriage was associated with adolescents' increased participation in decisions related to economics (adjusted odds ratio: 1.23; 95% confidence interval: 1.05-1.43) and health-care access (adjusted odds ratio: 1.18; 95% confidence interval: 1.01-1.40), but not with greater reported satisfaction with their control over these decisions.
","[{'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Tomar', 'Affiliation': 'Center on Gender Equity and Health, Division of Global Public Health, University of California, San Diego School of Medicine, La Jolla California; Joint Doctoral Program, San Diego State University/University of California San Diego, San Diego, California. Electronic address: stomar@health.ucsd.edu.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Johns', 'Affiliation': 'Center on Gender Equity and Health, Division of Global Public Health, University of California, San Diego School of Medicine, La Jolla California.'}, {'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Challa', 'Affiliation': 'Center on Gender Equity and Health, Division of Global Public Health, University of California, San Diego School of Medicine, La Jolla California.'}, {'ForeName': 'Mohamad I', 'Initials': 'MI', 'LastName': 'Brooks', 'Affiliation': 'Pathfinder International, Boston.'}, {'ForeName': 'Sani', 'Initials': 'S', 'LastName': 'Aliou', 'Affiliation': 'Pathfinder International, Boston.'}, {'ForeName': 'Nouhou', 'Initials': 'N', 'LastName': 'Abdoul-Moumouni', 'Affiliation': 'The OASIS Initiative, Niamey, Niger.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Raj', 'Affiliation': 'Center on Gender Equity and Health, Division of Global Public Health, University of California, San Diego School of Medicine, La Jolla California.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Silverman', 'Affiliation': 'Center on Gender Equity and Health, Division of Global Public Health, University of California, San Diego School of Medicine, La Jolla California.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2021.08.007']
1350,34810217,Trastuzumab Plus Endocrine Therapy or Chemotherapy as First-line Treatment for Patients with Hormone Receptor-Positive and HER2-Positive Metastatic Breast Cancer (SYSUCC-002).,"PURPOSE


There is no research evidence demonstrate which is the better partner strategy, endocrine therapy or chemotherapy, to combine with anti-HER2 therapy as the first-line management of hormone receptor (HR)-positive (HR+) and HER2-positive (HER2+) metastatic breast cancer (MBC). We wished to ascertain if trastuzumab plus endocrine therapy is noninferior to trastuzumab plus chemotherapy.
PATIENTS AND METHODS


We conducted an open-label, noninferiority, phase III, randomized, controlled trial (NCT01950182) at nine hospitals in China. Participants, stratified by previous adjuvant endocrine therapy and disease status (recurrent disease vs. de novo metastasis), were assigned randomly (1:1) to receive trastuzumab plus endocrine therapy (per investigator's choice of oestrogen-receptor modulators or aromatase inhibitor, with/without concurrent ovarian suppression) or chemotherapy (per investigator's choice of taxanes, capecitabine, or vinorelbine). The primary endpoint was progression-free survival (PFS) with a noninferiority upper margin of 1.35 for the HR. The intention-to-treat population was used in primary and safety analyses.
RESULTS


A total of 392 patients were enrolled and assigned randomly to receive trastuzumab plus endocrine therapy (ET group, n = 196) or trastuzumab plus chemotherapy (CT group, n = 196). After a median follow-up of 30.2 months [interquartile range (IQR) 15.0-44.7], the median PFS was 19.2 months [95% confidence interval (CI), 16.7-21.7)] in the ET group and 14.8 months (12.8-16.8) in the CT group (hazard ratio, 0.88; 95% CI, 0.71-1.09; Pnoninferiority < 0.0001). A significantly higher prevalence of toxicity was observed in the CT group compared with the ET group.
CONCLUSIONS


Trastuzumab plus endocrine therapy was noninferior to trastuzumab plus chemotherapy in patients with HR+HER2+ MBC.",2022,The primary endpoint was progression-free survival (PFS) with a non-inferiority upper margin of 1.35 for the hazard ratio.,"['392 patients', 'Patients with HR+HER2+ MBC were enrolled', 'Patients with Metastatic Breast Cancer with Hormone Receptor-positive and HER2-positive (SYSUCC-002', 'patients with HR+HER2+ MBC', 'nine hospitals in China', 'Participants, stratified by previous adjuvant endocrine therapy and disease status (recurrent disease  vs. de novo  metastasis', 'group, n=196']","['CT', 'trastuzumab plus endocrine therapy (ET group, n=196) or trastuzumab plus chemotherapy (CT', 'Trastuzumab Plus Endocrine Therapy or Chemotherapy', ""trastuzumab plus endocrine therapy (per investigator's choice of oestrogen-receptor modulators or aromatase inhibitor, with/without concurrent ovarian suppression) or chemotherapy (per investigator's choice of taxanes, capecitabine, or vinorelbine"", 'Trastuzumab plus endocrine therapy', 'trastuzumab plus chemotherapy', 'trastuzumab plus endocrine therapy']","['median PFS', 'prevalence of toxicity', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0065839', 'cui_str': 'Carbendazim'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0677922', 'cui_str': 'Ovarian ablation'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",392.0,0.18584,The primary endpoint was progression-free survival (PFS) with a non-inferiority upper margin of 1.35 for the hazard ratio.,"[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Hua', 'Affiliation': 'Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Xi-Wen', 'Initials': 'XW', 'LastName': 'Bi', 'Affiliation': 'Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Jian-Li', 'Initials': 'JL', 'LastName': 'Zhao', 'Affiliation': 'Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yan-Xia', 'Initials': 'YX', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Thyroid and Breast Surgery, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Zhi-Yong', 'Initials': 'ZY', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology Surgery, Diagnosis and Treatment Center of Breast Diseases, Affiliated Shantou Hospital, Sun Yat-sen University, Shantou, China.'}, {'ForeName': 'Yuan-Qi', 'Initials': 'YQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Vascular Surgery, Affiliated Hospital of Guangdong Medical College, Zhanjiang, China.'}, {'ForeName': 'Le-Hong', 'Initials': 'LH', 'LastName': 'Zhang', 'Affiliation': 'Department of Breast Oncology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'An-Qing', 'Initials': 'AQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Breast Oncology, Maternal and Child Health Care Hospital of Guangdong Province, Guangzhou, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': ""Department of Breast Oncology, Lianjiang Pepole's Hospital, Lianjiang, China.""}, {'ForeName': 'Xin-Mei', 'Initials': 'XM', 'LastName': 'Liu', 'Affiliation': ""Department of Breast Oncology, Haikou People's Hospital, Haikou, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Good Clinical Practice, the State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Ruo-Xi', 'Initials': 'RX', 'LastName': 'Hong', 'Affiliation': 'Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Kui-Kui', 'Initials': 'KK', 'LastName': 'Jiang', 'Affiliation': 'Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Xue', 'Affiliation': 'Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'An', 'Affiliation': 'Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Yong-Yi', 'Initials': 'YY', 'LastName': 'Zhong', 'Affiliation': 'Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Shu-Sen', 'Initials': 'SS', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Jia-Jia', 'Initials': 'JJ', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Zhong-Yu', 'Initials': 'ZY', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, the State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-3435']
1351,34812466,Effects of strawberries on bone biomarkers in pre- and stage 1-hypertensive postmenopausal women: a secondary analysis.,"Postmenopausal women experience an increase in bone remodeling with the rate of bone resorption superseding the rate of bone formation. This results in a net bone loss with a subsequent increased risk for osteoporosis and fractures. High blood pressure (BP) has been associated with loss of bone mineral density and increased propensity to fractures. Strawberries are rich in polyphenols, which have been shown to have anti-hypertensive and bone-protective properties. Thus, we examined whether daily intake of strawberries would positively affect biomarkers of bone metabolism in postmenopausal women with pre- and stage 1-hypertension. Participants (age: 59 ± 6 years; body mass index: 31.5 ± 4.1 kg m -2 ; systolic BP: 140 ± 13 mmHg) were randomly assigned to consume (1) 50 g of freeze-dried strawberry powder (FDSP), (2) 25 g FDSP + 25 g of placebo powder, or (3) 50 g placebo powder for eight weeks. Results indicate a significant time-by-treatment interaction ( P  = 0.04) for serum insulin-like growth factor (IGF)-1, a hormone that plays a major role in bone formation. Serum concentrations of bone-specific alkaline phosphatase, a marker of bone formation, and tartrate-resistant acid phosphatase-5b, a specific marker of bone resorption, were not affected by FDSP compared to placebo. Although not statistically significant, after eight weeks, osteocalcin increased in the 50 g FDSP group with a large effect size ( d  = 0.6) when compared to the placebo-control group. Adiponectin increased by 5% and 6% in the 25 g and 50 g FDSP groups, respectively, while it declined in the placebo-control group by 25% ( P  = 0.03 for time-by-treatment interaction). Our findings suggest that consumption of 25 g FDSP increases IGF-1 in postmenopausal women with pre- and stage 1-hypertension. However, further studies are needed to assert the effectiveness of a strawberry intervention for bone health.",2021,"Results indicate a significant time-by-treatment interaction ( P  = 0.04) for serum insulin-like growth factor (IGF)-1, a hormone that plays a major role in bone formation.","['Postmenopausal women experience', 'pre- and stage 1-hypertensive postmenopausal women', 'postmenopausal women with pre- and stage 1-hypertension', 'Participants (age: 59 ± 6 years; body mass index: 31.5 ± 4.1 kg m -2 ; systolic BP: 140 ± 13 mmHg']","['strawberries', 'placebo', 'FDSP', 'freeze-dried strawberry powder (FDSP), (2) 25 g FDSP + 25 g of placebo powder, or (3) 50 g placebo powder']","['bone remodeling', 'Serum concentrations of bone-specific alkaline phosphatase, a marker of bone formation, and tartrate-resistant acid phosphatase-5b, a specific marker of bone resorption', 'Adiponectin', 'IGF-1', 'osteocalcin', 'bone biomarkers', 'High blood pressure (BP', 'bone metabolism']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}]","[{'cui': 'C0457802', 'cui_str': 'Strawberry'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0456638', 'cui_str': '25G'}]","[{'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0557617,"Results indicate a significant time-by-treatment interaction ( P  = 0.04) for serum insulin-like growth factor (IGF)-1, a hormone that plays a major role in bone formation.","[{'ForeName': 'Rafaela G', 'Initials': 'RG', 'LastName': 'Feresin', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, 32306, USA. barjmandi@fsu.edu.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Johnson', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, 32306, USA. barjmandi@fsu.edu.'}, {'ForeName': 'Marcus L', 'Initials': 'ML', 'LastName': 'Elam', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, 32306, USA. barjmandi@fsu.edu.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Pourafshar', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, 32306, USA. barjmandi@fsu.edu.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Navaei', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, 32306, USA. barjmandi@fsu.edu.'}, {'ForeName': 'Neda S', 'Initials': 'NS', 'LastName': 'Akhavan', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, 32306, USA. barjmandi@fsu.edu.'}, {'ForeName': 'Gershon', 'Initials': 'G', 'LastName': 'Tenenbaum', 'Affiliation': 'Department of Educational Psychology and Learning Systems, Florida State University, Tallahassee, FL, 32306, USA.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Figueroa', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, 32306, USA. barjmandi@fsu.edu.'}, {'ForeName': 'Bahram H', 'Initials': 'BH', 'LastName': 'Arjmandi', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Florida State University, Tallahassee, FL, 32306, USA. barjmandi@fsu.edu.'}]",Food & function,['10.1039/d1fo01555a']
1352,34813901,Functional improvements to 6 months of physical activity are not related to changes in size or density of multiple lower-extremity muscles in mobility-limited older individuals.,"Older adults are encouraged to engage in multicomponent physical activity, which includes aerobic and muscle-strengthening activities. The current work is an extension of the Vitality, Independence, and Vigor in the Elderly 2 (VIVE2) study - a 6-month multicenter, randomized, placebo-controlled trial of physical activity and nutritional supplementation in community dwelling 70-year-old seniors. Here, we examined whether the magnitude of changes in muscle size and quality differed between major lower-extremity muscle groups and related these changes to functional outcomes. We also examined whether daily vitamin-D-enriched protein supplementation could augment the response to structured physical activity. Forty-nine men and women (77 ± 5 yrs) performed brisk walking, muscle-strengthening exercises for the lower limbs, and balance training 3 times weekly for 6 months. Participants were randomized to daily intake of a nutritional supplement (20 g whey protein + 800 IU vitamin D), or a placebo. Muscle cross-sectional area (CSA) and radiological attenuation (RA) were assessed in 8 different muscle groups using single-slice CT scans of the hip, thigh, and calf at baseline and after the intervention. Walking speed and performance in the Short Physical Performance Battery (SPPB) were also measured. For both CSA and RA, there were muscle group × time interactions (P < 0.01). Significant increases in CSA were observed in 2 of the 8 muscles studied, namely the knee extensors (1.9%) and the hip adductors (2.8%). For RA, increases were observed in 4 of 8 muscle groups, namely the hip flexors (1.1 HU), hip adductors (0.9 HU), knee extensors (1.2 HU), and ankle dorsiflexors (0.8 HU). No additive effect of nutritional supplementation was observed. While walking speed (13%) and SPPB performance (38%) improved markedly, multivariate analysis showed that these changes were not associated with the changes in muscle CSA and RA after the intervention. We conclude that this type of multicomponent physical activity program results in significant improvements in physical function despite relatively small changes in muscle size and quality of some, but not all, of the measured lower extremity muscles involved in locomotion.",2022,"While walking speed (13%) and SPPB performance (38%) improved markedly, multivariate analysis showed that these changes were not associated with the changes in muscle CSA and RA after the intervention.","['Forty-nine men and women (77\u202f±\u202f5\u202fyrs) performed', 'Older adults', 'community dwelling 70-year-old seniors']","['nutritional supplement (20\u202fg whey protein\u202f+\u202f800\u202fIU vitamin D', 'multicomponent physical activity program', 'brisk walking, muscle-strengthening exercises for the lower limbs, and balance training 3 times weekly for 6\u202fmonths', 'daily vitamin-D-enriched protein supplementation', 'physical activity and nutritional supplementation', 'placebo']","['ankle dorsiflexors', 'CSA', 'SPPB performance', 'Muscle cross-sectional area (CSA) and radiological attenuation (RA', 'muscle CSA and RA', 'muscle size and quality', 'Walking speed and performance in the Short Physical Performance Battery (SPPB']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}]",,0.0393979,"While walking speed (13%) and SPPB performance (38%) improved markedly, multivariate analysis showed that these changes were not associated with the changes in muscle CSA and RA after the intervention.","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Skoglund', 'Affiliation': 'Division of Clinical Physiology, Department of Laboratory Medicine, Karolinska Institutet, Alfred Nobles Allé 8B, 141 52 Huddinge, Sweden & Unit of Clinical Physiology, Karolinska University Hospital, Stockholm, Sweden; Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Box 564, 751 22 Uppsala, Sweden. Electronic address: elisabeth.skoglund@medsci.uu.se.'}, {'ForeName': 'Tommy R', 'Initials': 'TR', 'LastName': 'Lundberg', 'Affiliation': 'Division of Clinical Physiology, Department of Laboratory Medicine, Karolinska Institutet, Alfred Nobles Allé 8B, 141 52 Huddinge, Sweden & Unit of Clinical Physiology, Karolinska University Hospital, Stockholm, Sweden. Electronic address: tommy.lundberg@ki.se.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rullman', 'Affiliation': 'Division of Clinical Physiology, Department of Laboratory Medicine, Karolinska Institutet, Alfred Nobles Allé 8B, 141 52 Huddinge, Sweden & Unit of Clinical Physiology, Karolinska University Hospital, Stockholm, Sweden. Electronic address: eric.rullman@ki.se.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington Street, Boston, MA 02111, USA. Electronic address: roger.fielding@tufts.edu.'}, {'ForeName': 'Dylan R', 'Initials': 'DR', 'LastName': 'Kirn', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington Street, Boston, MA 02111, USA. Electronic address: DKIRN@mgh.harvard.edu.'}, {'ForeName': 'Davis A', 'Initials': 'DA', 'LastName': 'Englund', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington Street, Boston, MA 02111, USA. Electronic address: Englund.Davis@mayo.edu.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'von Berens', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Box 564, 751 22 Uppsala, Sweden; Stockholm Gerontology Research Center, Sveavägen 155, 113 46 Stockholm, Sweden. Electronic address: Asa.vonBerens@aldrecentrum.se.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Koochek', 'Affiliation': 'Department of food studies, nutrition and dietetics, Uppsala University, Box 560, 751 22 Uppsala, Sweden. Electronic address: afsaneh.koochek@ikv.uu.se.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cederholm', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Box 564, 751 22 Uppsala, Sweden. Electronic address: tommy.cederholm@pubcare.uu.se.'}, {'ForeName': 'Hans E', 'Initials': 'HE', 'LastName': 'Berg', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, 171 77 Stockholm, Sweden & Department of Orthopedic Surgery, Karolinska University Hospital, Stockholm, Sweden. Electronic address: hans.er.berg@sll.se.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gustafsson', 'Affiliation': 'Division of Clinical Physiology, Department of Laboratory Medicine, Karolinska Institutet, Alfred Nobles Allé 8B, 141 52 Huddinge, Sweden & Unit of Clinical Physiology, Karolinska University Hospital, Stockholm, Sweden. Electronic address: thomas.gustafsson@ki.se.'}]",Experimental gerontology,['10.1016/j.exger.2021.111631']
1353,34845408,Acute and Short-Term Effects of Dry Needling in Patients with Chronic Nonspecific Low Back Pain and Hamstring Tightness: A Pilot Study.,"Background


Chronic nonspecific low back pain (LBP) is one of the common health issues. Hamstring tightness contributes to the development of LBP. This study aimed to investigate the acute and short-term effects of deep dry needling (DN) in patients with chronic nonspecific LBP and hamstring muscle tightness.
Methods


A single-group pretest-posttest clinical study design was followed. The outcome measures were the visual analog scale (VAS), passive knee extension (PKE) test, finger-floor distance (FFD) test, and functional rating index (FRI). Patients underwent one session of deep DN of three points on both hamstring muscles, each point for one minute. Patients were assessed before (T0), immediately after (T1), and one week after DN (T2). The FRI was assessed at T0 and T2.
Results


Ten women with a mean age of 21.1 years (SD = 1.6) participated in the study. Significant large effect sizes in VAS pain reduction ( d  = 1.25) and PKE hamstring tightness were obtained (hamstring: right,  d   =  0.82; left,  d  = 0.88) at T2. Medium effect sizes were obtained for FFD ( d  = 0.45) and FRI ( d  = 0.72) at T2.
Conclusion


A single session of deep DN improved pain and function and increased hamstring flexibility. This pilot study supports the use of DN in patients with LBP and hamstring tightness; however, future research with a rigorous study design of randomized controlled trial is required to confirm the findings. This trial is registered with IRCT20180511039612N1.",2021,"Medium effect sizes were obtained for FFD ( d  = 0.45) and FRI ( d  = 0.72) at T2.
","['Ten women with a mean age of 21.1 years (SD\u2009=\u20091.6) participated in the study', '\n\n\nChronic nonspecific low back pain (LBP', 'Patients with Chronic Nonspecific Low Back Pain and Hamstring Tightness', 'patients with LBP and hamstring tightness', 'patients with chronic nonspecific LBP and hamstring muscle tightness']","['Dry Needling', 'deep dry needling (DN']","['PKE hamstring tightness', 'VAS pain reduction', 'visual analog scale (VAS), passive knee extension (PKE) test, finger-floor distance (FFD) test, and functional rating index (FRI', 'FRI', 'pain and function and increased hamstring flexibility']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",10.0,0.114337,"Medium effect sizes were obtained for FFD ( d  = 0.45) and FRI ( d  = 0.72) at T2.
","[{'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Bazzaz-Yamchi', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soofia', 'Initials': 'S', 'LastName': 'Naghdi', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Nakhostin-Ansari', 'Affiliation': 'Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Monavar', 'Initials': 'M', 'LastName': 'Hadizadeh', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Noureddin Nakhostin', 'Initials': 'NN', 'LastName': 'Ansari', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Moghimi', 'Affiliation': 'Research Center for War-affected People, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hasson', 'Affiliation': 'Department of Physical Therapy, Augusta University, Augusta, Georgia, USA.'}]",TheScientificWorldJournal,['10.1155/2021/7259956']
1354,34846555,Deep Learning Image Processing Enables 40% Faster Spinal MR Scans Which Match or Exceed Quality of Standard of Care : A Prospective Multicenter Multireader Study.,"OBJECTIVE


This prospective multicenter multireader study evaluated the performance of 40% scan-time reduced spinal magnetic resonance imaging (MRI) reconstructed with deep learning (DL).
METHODS


A total of 61 patients underwent standard of care (SOC) and accelerated (FAST) spine MRI. DL was used to enhance the accelerated set (FAST-DL). Three neuroradiologists were presented with paired side-by-side datasets (666 series). Datasets were blinded and randomized in sequence and left-right display order. Image features were preference rated. Structural similarity index (SSIM) and per pixel L1 was assessed for the image sets pre and post DL-enhancement as a quantitative assessment of image integrity impact.
RESULTS


FAST-DL was qualitatively better than SOC for perceived signal-to-noise ratio (SNR) and artifacts and equivalent for other features. Quantitative SSIM was high, supporting the absence of image corruption by DL processing.
CONCLUSION


DL enables 40% spine MRI scan time reduction while maintaining diagnostic integrity and image quality with perceived benefits in SNR and artifact reduction, suggesting potential for clinical practice utility.",2022,"RESULTS


FAST-DL was qualitatively better than SOC for perceived signal-to-noise ratio (SNR) and artifacts and equivalent for other features.",['61\xa0patients underwent standard of care (SOC) and accelerated (FAST) spine MRI'],"['40% scan-time reduced spinal magnetic resonance imaging (MRI) reconstructed with deep learning (DL', 'Care ']",['Structural similarity index (SSIM) and per pixel L1'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}]",3.0,0.0382055,"RESULTS


FAST-DL was qualitatively better than SOC for perceived signal-to-noise ratio (SNR) and artifacts and equivalent for other features.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bash', 'Affiliation': 'RadNet-San Fernando Interventional Radiology, 1510 Cotner Ave., 90025, Los Angeles, CA, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Johnson', 'Affiliation': 'Rayus Radiology, 5775 Wayzata Blvd. Suite\xa0190, 55416, St. Louis Park, MN, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Gibbs', 'Affiliation': 'Dept. of Neuroradiology, Mayo Clinic, 5777 E. Mayo Blvd., 85054, Phoenix, AZ, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Apple, One Apple Park Way, 95014, Cupertino, CA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shankaranarayanan', 'Affiliation': 'Subtle Medical, 883 Santa Cruz Ave, 94025, Menlo Park, CA, USA.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Tanenbaum', 'Affiliation': 'RadNet-San Fernando Interventional Radiology, 1510 Cotner Ave., 90025, Los Angeles, CA, USA. nuromri@gmail.com.'}]",Clinical neuroradiology,['10.1007/s00062-021-01121-2']
1355,34847963,Cognitive behavioral therapy for irritable bowel syndrome induces bidirectional alterations in the brain-gut-microbiome axis associated with gastrointestinal symptom improvement.,"BACKGROUND


There is growing recognition that bidirectional signaling between the digestive tract and the brain contributes to irritable bowel syndrome (IBS). We recently showed in a large randomized controlled trial that cognitive behavioral therapy (CBT) reduces IBS symptom severity. This study investigated whether baseline brain and gut microbiome parameters predict CBT response and whether response is associated with changes in the brain-gut-microbiome (BGM) axis.
METHODS


Eighty-four Rome III-diagnosed IBS patients receiving CBT were drawn from the Irritable Bowel Syndrome Outcome Study (IBSOS; ClinicalTrials.gov NCT00738920) for multimodal brain imaging and psychological assessments at baseline and after study completion. Fecal samples were collected at baseline and post-treatment from 34 CBT recipients for 16S rRNA gene sequencing, untargeted metabolomics, and measurement of short-chain fatty acids. Clinical measures, brain functional connectivity and microstructure, and microbiome features associated with CBT response were identified by multivariate linear and negative binomial models.
RESULTS


At baseline, CBT responders had increased fecal serotonin levels, and increased Clostridiales and decreased Bacteroides compared to non-responders. A random forests classifier containing 11 microbial genera predicted CBT response with high accuracy (AUROC 0.96). Following treatment, CBT responders demonstrated reduced functional connectivity in regions of the sensorimotor, brainstem, salience, and default mode networks and changes in white matter in the basal ganglia and other structures. Brain changes correlated with microbiome shifts including Bacteroides expansion in responders.
CONCLUSIONS


Pre-treatment intestinal microbiota and serotonin levels were associated with CBT response, suggesting that peripheral signals from the microbiota can modulate central processes affected by CBT that generate abdominal symptoms in IBS. CBT response is characterized by co-correlated shifts in brain networks and gut microbiome that may reflect top-down effects of the brain on the microbiome during CBT. Video abstract.",2021,"Following treatment, CBT responders demonstrated reduced functional connectivity in regions of the sensorimotor, brainstem, salience, and default mode networks and changes in white matter in the basal ganglia and other structures.",['Eighty-four Rome III-diagnosed IBS patients receiving'],"['Cognitive behavioral therapy', 'CBT', 'cognitive behavioral therapy (CBT']","['fecal serotonin levels', 'Fecal samples', 'IBS symptom severity', 'Clinical measures, brain functional connectivity and microstructure, and microbiome features associated with CBT response', 'functional connectivity', 'CBT response', 'Clostridiales and decreased Bacteroides']","[{'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0202217', 'cui_str': 'Serotonin measurement'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1210563', 'cui_str': 'Order Clostridiales'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0998678,"Following treatment, CBT responders demonstrated reduced functional connectivity in regions of the sensorimotor, brainstem, salience, and default mode networks and changes in white matter in the basal ganglia and other structures.","[{'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Jacobs', 'Affiliation': 'G. Oppenheimer Center for Neurobiology of Stress and Resilience, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Arpana', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'G. Oppenheimer Center for Neurobiology of Stress and Resilience, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Ravi R', 'Initials': 'RR', 'LastName': 'Bhatt', 'Affiliation': 'Imaging Genetics Center, Mark and Mary Stevens Institute for Neuroimaging and Informatics, Keck School of Medicine at USC, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Brawer', 'Affiliation': 'G. Oppenheimer Center for Neurobiology of Stress and Resilience, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': 'G. Oppenheimer Center for Neurobiology of Stress and Resilience, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Tillisch', 'Affiliation': 'G. Oppenheimer Center for Neurobiology of Stress and Resilience, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Lagishetty', 'Affiliation': 'David Geffen School of Medicine, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Firth', 'Affiliation': 'Division of Behavioral Medicine, Jacobs School of Medicine, University at Buffalo, SUNY, Buffalo, NY, USA.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Gudleski', 'Affiliation': 'Division of Behavioral Medicine, Jacobs School of Medicine, University at Buffalo, SUNY, Buffalo, NY, USA.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Ellingson', 'Affiliation': 'David Geffen School of Medicine, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Labus', 'Affiliation': 'G. Oppenheimer Center for Neurobiology of Stress and Resilience, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Naliboff', 'Affiliation': 'G. Oppenheimer Center for Neurobiology of Stress and Resilience, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Lackner', 'Affiliation': 'Division of Behavioral Medicine, Jacobs School of Medicine, University at Buffalo, SUNY, Buffalo, NY, USA.'}, {'ForeName': 'Emeran A', 'Initials': 'EA', 'LastName': 'Mayer', 'Affiliation': 'G. Oppenheimer Center for Neurobiology of Stress and Resilience, UCLA, Los Angeles, CA, USA. emayer@ucla.edu.'}]",Microbiome,['10.1186/s40168-021-01188-6']
1356,34852310,Peri-implant parameters and bone metabolic markers among water-pipe users treated with photodynamic therapy.,"AIM


The study aimed to evaluate the efficacy of Mechanical debridement (MD) with and without adjunct antimicrobial photodynamic therapy (aPDT) in the treatment of peri‑implantitis among waterpipe smokers (WPS) and non-smokers with peri‑implantitis MATERIAL AND METHODS: Participants were stratified into two groups. Group 1: Subjects who smoked water pipes for the last 2 years with peri‑implant disease were treated with aPDT adjunct to MD and group 2: Participants who did not use water pipes in the last 2 years but have periimplantitis (controls) were treated with MD only. Participants were scrutinized with peri‑implantitis (PI) in one dental implant at least based on the inclusion and exclusion criteria. Using structured questionnaire information was gathered from participants. All participants underwent mechanical debridement (MD). Participants of WPS underwent antimicrobial photodynamic therapy (aPDT). Peri implant inflammatory parameters (PI, BI, PD, and CBL) were assessed in all participant at baseline, 3 months and 6 months follow-up. Periimplant sulcular fluid was collected for assessment of bone metabolic biomarkers RANK-L and OPG. For immunological and clinical peri‑implant parameters analysis of variance (ANOVA) and Kruskal-Wallis test were used. For multiple comparisons, Bonferroni post hoc test was deployed.
RESULTS


Clinical periodontal parameters at baseline were significantly different in the control group PI (49.8 ± 10.5), BI(46.8 ± 7.7), and PD (5.0 ± 1.8) compared to WPS PI (56.1 ± 12.0), BI (40.9 ± 8.3), and PD (5.6 ± 1.5) (p < 0.05). At 3 months follow-up after PDT, PI (19.1 ± 7.7) and PD (3.9 ± 1.4) were significantly lower in the control group compared to WPS group PI (23.5 ± 8.4) and PD (4.5 ± 1.2) (p < 0.05). Whereas, BI of control (16.3 ± 6.8) and WPS group (17.1 ± 5.3) at 3 months follow-up was comparable (p > 0.05). At six months follow up following PDT, PI (15.7 ± 5.5) and PD (3.4 ± 1.2) was significantly lower in the control group compared to participants with water piped users PI (18.6 ± 7.4) and PD (3.9 ± 1.3) (p < 0.05). No significant difference was noted in BI in both groups (p > 0.05). Participants treated with PDT adjunct to MD demonstrated significantly reduced mean RANK-L levels at both 3 and 6 months (p<0.05).
CONCLUSION


aPDT adjunctive to MD improved periodontal parameters i.e., plaque index, pocket depth, and crestal bone loss along with metabolic marker RANK-L in water pipe smokers compared to non piped smokers.",2022,"aPDT adjunctive to MD improved periodontal parameters i.e., plaque index, pocket depth, and crestal bone loss along with metabolic marker RANK-L in water pipe smokers compared to non piped smokers.","['Participants were scrutinized with peri-implantitis (PI) in one dental implant at least based on the inclusion and exclusion criteria', 'and group 2: Participants who did not use water pipes in the last 2 years but have periimplantitis (controls) were treated with MD only', 'waterpipe smokers (WPS) and non-smokers with peri-implantitis', 'Subjects who smoked water pipes for the last 2 years with peri-implant disease']","['photodynamic therapy', 'aPDT adjunct to MD', 'Mechanical debridement (MD) with and without adjunct antimicrobial photodynamic therapy (aPDT', 'mechanical debridement (MD', 'PDT adjunct to MD', 'antimicrobial photodynamic therapy (aPDT']","['Peri implant inflammatory parameters (PI, BI, PD, and CBL', 'aPDT adjunctive to MD improved periodontal parameters i.e., plaque index, pocket depth, and crestal bone loss', 'bone metabolic markers', 'mean RANK-L levels', 'BI']","[{'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0071109', 'cui_str': ""piperazine-N,N'-bis(2-ethanesulfonic acid)""}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C4302493', 'cui_str': 'Hookah pipe'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0396345,"aPDT adjunctive to MD improved periodontal parameters i.e., plaque index, pocket depth, and crestal bone loss along with metabolic marker RANK-L in water pipe smokers compared to non piped smokers.","[{'ForeName': 'Nawwaf', 'Initials': 'N', 'LastName': 'Al-Hamoudi', 'Affiliation': 'Department of Periodontics and Community Dentistry, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia. Electronic address: nalhamoudi@ksu.edu.sa.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Alali', 'Affiliation': 'Department of Maxillofacial Surgery, College of Dentistry, King Saud University, Riyadh, Saudi Arabia. Electronic address: Yalali@ksu.edu.sa.'}, {'ForeName': 'Khulud', 'Initials': 'K', 'LastName': 'Al-Aali', 'Affiliation': 'Department Of Clinical Dental Sciences, College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia. Electronic address: kaalaali@pnu.edu.sa.'}, {'ForeName': 'Abdulkareem A', 'Initials': 'AA', 'LastName': 'Alhumaidan', 'Affiliation': 'Preventive dental sciences department, College of Dentistry, Imam Abdulrahman bin Faisal University. Dammam, Saudi Arabia. Electronic address: aaalhumaidan@iau.edu.sa.'}, {'ForeName': 'Emal', 'Initials': 'E', 'LastName': 'Heer', 'Affiliation': 'Department of Pharmacology, Dr Ishrat Ul Ebad Khan Institute of Oral Health Sciences, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Syeda A', 'Initials': 'SA', 'LastName': 'Tanveer', 'Affiliation': 'Department of Operative Dentistry, College of Dentistry, Dow International Dental College, Karachi, Pakistan.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Naseem', 'Affiliation': 'Department of Community and Preventive Dental Sciences, College of Dentistry, Dow International Dental College, Karachi, Pakistan. Electronic address: mustafa.naseem@duhs.edu.pk.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Vohra', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University;\xa0Research Chair for Biological Research in Dental Health, College of Dentistry, Riyadh 11545, Saudi Arabia. Electronic address: fvohra@ksu.edu.sa.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Abduljabbar', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University;\xa0Research Chair for Biological Research in Dental Health, College of Dentistry, Riyadh 11545, Saudi Arabia. Electronic address: tajabbar@ksu.edu.sa.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102655']
1357,34853114,"Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial.","INTRODUCTION


Psilocybin-assisted therapy may be a new treatment for major depressive disorder (MDD), with encouraging data from pilot trials. In this trial (short name: PsiDeR) we aimed to test the feasibility of a parallel-group, randomised, placebo-controlled design. The primary outcomes in this trial are measures of feasibility: recruitment rates, dropout rates and the variance of the primary outcome measure of depression.
METHODS AND ANALYSIS


We are recruiting up to 60 participants at a single centre in London, UK who are unresponsive to, or intolerant of, at least two evidence-based treatments for MDD. Participants are randomised to receive a single dosing session of 25 mg psilocybin or a placebo. All participants receive a package of psychological therapy. The primary outcome measure for depression is the Montgomery Asberg Depression Rating Scale collected by blinded, independent raters. The primary endpoint is at 3 weeks, and the total follow-up is 6 weeks. With further informed consent, this study collects neuroimaging and omics data for mechanism and biomarker analyses and offers participants an open label extension consisting of a further, open label dose of 25 mg of psilocybin.
ETHICS AND DISSEMINATION


All participants will be required to provide written informed consent. The trial has been authorised by the National Research Ethics Committee (20-LO/0206), Health Research Authority (252750) and Medicine's and Healthcare Products Regulatory Agency (CTA 14523/0284/001-0001) in the UK. Dissemination of results will occur via a peer-reviewed publication and other relevant media.
TRIAL REGISTRATION NUMBERS


EUDRACT2018-003573-97; NCT04959253.",2021,"The primary outcomes in this trial are measures of feasibility: recruitment rates, dropout rates and the variance of the primary outcome measure of depression.
","['resistant major depressive disorder (PsiDeR', '60 participants at a single centre in London, UK who are unresponsive to, or intolerant of, at least two evidence-based treatments for MDD', 'major depressive disorder (MDD']","['Psilocybin-assisted therapy', 'placebo', 'psilocybin or a placebo', 'package of psychological therapy']","['depression is the Montgomery Asberg Depression Rating Scale', 'feasibility: recruitment rates, dropout rates and the variance of the primary outcome measure of depression']","[{'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",,0.804924,"The primary outcomes in this trial are measures of feasibility: recruitment rates, dropout rates and the variance of the primary outcome measure of depression.
","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Rucker', 'Affiliation': ""Department of Psychological Medicine, King's College London, London, UK james.rucker@kcl.ac.uk.""}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Jafari', 'Affiliation': ""Department of Biostatistics, King's College London, London, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Mantingh', 'Affiliation': ""Department of Psychological Medicine, King's College London, London, UK.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bird', 'Affiliation': ""Department of Psychological Medicine, King's College London, London, UK.""}, {'ForeName': 'Nadav Liam', 'Initials': 'NL', 'LastName': 'Modlin', 'Affiliation': ""Department of Psychological Medicine, King's College London, London, UK.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Knight', 'Affiliation': ""Department of Psychological Medicine, King's College London, London, UK.""}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Reinholdt', 'Affiliation': ""Department of Psychological Medicine, King's College London, London, UK.""}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Day', 'Affiliation': ""Department of Psychological Medicine, King's College London, London, UK.""}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Carter', 'Affiliation': ""Department of Biostatistics, King's College London, London, UK.""}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Young', 'Affiliation': ""Department of Psychological Medicine, King's College London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2021-056091']
1358,34853111,Effectiveness of a digital dietary intervention program targeting young adults before parenthood: protocol for the PREPARED randomised controlled trial.,"INTRODUCTION


The importance of preconception health for lifelong physical and mental health in the next generation has gained increasing recognition in recent years. Preconception paternal and maternal risk factors such as obesity and inadequate diet affect the metabolic and cardiovascular health of their offspring later in life. This highlights the importance of diet and dietary behaviour in the years before parenthood. In our project, PREPARED, we will evaluate the effectiveness of a digital intervention targeting young adults. Our primary aim is to improve participants' preconception diet, and our secondary aim is to improve preconception quality of life and maternal and child perinatal outcomes.
METHODS AND ANALYSIS


We plan to recruit 7000 men and women individually, aged 20-35 years without children, to be randomised to an intervention or a control group. The intervention group will receive access to a digital resource for 6 months promoting a healthy diet for their health now, later in life and for the next generation. Follow-up is up to 20 years or until they have their first child. To evaluate intervention effects, we will collect dietary data (2×24-hour dietary recalls and a screener). For those participants for which birth ensues, we will link study data with data from the Medical Birth Registry of Norway on maternal and child perinatal outcomes.
ETHICS AND DISSEMINATION


The study is approved by the Regional Ethics Committee, the Norwegian Data Protection Service and our Faculty Ethical Committee (REC: 78104, NSD: 907212, FEC 20/10119). Participation is voluntary and all participants will provide informed consent. Participants can withdraw their consent without giving any reason. Findings will be communicated to the public through a project website and social media, and to professionals through conferences and peer-reviewed papers.
TRIAL REGISTRATION NUMBER


ISRCTN44294662.",2021,The importance of preconception health for lifelong physical and mental health in the next generation has gained increasing recognition in recent years.,"['young adults before parenthood', 'young adults', '7000 men and women individually, aged 20-35 years without children']","['digital intervention targeting', 'digital dietary intervention program', 'intervention group will receive access to a digital resource for 6 months promoting a healthy diet']",['preconception quality of life and maternal and child perinatal outcomes'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337469', 'cui_str': 'Parenthood'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.091218,The importance of preconception health for lifelong physical and mental health in the next generation has gained increasing recognition in recent years.,"[{'ForeName': 'Nina Cecilie', 'Initials': 'NC', 'LastName': 'Øverby', 'Affiliation': 'Department of Nutrition and Public Health, Universitetet i Agder, Kristiansand, Vest-Agder, Norway nina.c.overby@uia.no.'}, {'ForeName': 'Anine C', 'Initials': 'AC', 'LastName': 'Medin', 'Affiliation': 'Department of Nutrition and Public Health, Universitetet i Agder, Kristiansand, Vest-Agder, Norway.'}, {'ForeName': 'Erlend Larsen', 'Initials': 'EL', 'LastName': 'Valen', 'Affiliation': 'Department of Nutrition and Public Health, Universitetet i Agder, Kristiansand, Vest-Agder, Norway.'}, {'ForeName': 'Lorentz', 'Initials': 'L', 'LastName': 'Salvesen', 'Affiliation': 'Department of Nutrition and Public Health, Universitetet i Agder, Kristiansand, Vest-Agder, Norway.'}, {'ForeName': 'Andrew Keith', 'Initials': 'AK', 'LastName': 'Wills', 'Affiliation': 'Department of Nutrition and Public Health, Universitetet i Agder, Kristiansand, Vest-Agder, Norway.'}, {'ForeName': 'Dagrun', 'Initials': 'D', 'LastName': 'Engeset', 'Affiliation': 'Department of Nutrition and Public Health, Universitetet i Agder, Kristiansand, Vest-Agder, Norway.'}, {'ForeName': 'Frøydis N', 'Initials': 'FN', 'LastName': 'Vik', 'Affiliation': 'Department of Nutrition and Public Health, Universitetet i Agder, Kristiansand, Vest-Agder, Norway.'}, {'ForeName': 'Elisabet R', 'Initials': 'ER', 'LastName': 'Hillesund', 'Affiliation': 'Department of Nutrition and Public Health, Universitetet i Agder, Kristiansand, Vest-Agder, Norway.'}]",BMJ open,['10.1136/bmjopen-2021-055116']
1359,34853109,Exploring patients' experiences of analgesia after major lower limb amputation: a qualitative study.,"OBJECTIVES


To explore patient experiences, understanding and perceptions of analgesia following major lower limb amputation.
DESIGN


Qualitative interview study, conducted as part of a randomised controlled feasibility trial.
SETTING


Participants were recruited from two general hospitals in South Wales.
PARTICIPANTS


Interview participants were patients enrolled in PLACEMENT (Perineural Local Anaesthetic Catheter aftEr Major lowEr limb amputatioN Trial): a randomised controlled feasibility trial comparing the use of perineural catheter (PNC) versus standard care for postoperative pain relief following major lower limb amputation. PLACEMENT participants who completed 5-day postoperative follow-up, were able and willing to participate in a face-to-face interview, and had consented to be contacted, were eligible to take part in the qualitative study. A total of 20 interviews were conducted with 14 participants: 10 male and 4 female.
METHODS


Semi-structured, face-to-face interviews were conducted with participants over two time points: (1) up to 1 month and (2) at least 6 months following amputation. Interviews were audio-recorded, transcribed verbatim and analysed using a framework approach.
RESULTS


Interviews revealed unanticipated benefits of PNC usage for postoperative pain relief. Participants valued the localised and continuous nature of this mode of analgesia in comparison to opioids. Concerns about opioid dependence and side effects of pain relief medication were raised by participants in both treatment groups, with some reporting trying to limit their intake of analgesics.
CONCLUSIONS


Findings suggest routine placement of a PNC following major lower limb amputation could reduce postoperative pain, particularly for patient groups at risk of postoperative delirium. This method of analgesic delivery also has the potential to reduce preoperative anxiety, alleviate the burden of pain management and minimise opioid use. Future research could further examine the comparison between patient-controlled analgesia and continuous analgesia in relation to patient anxiety and satisfaction with pain management.
TRIAL REGISTRATION NUMBER


ISRCTN: 85710690; EudraCT: 2016-003544-37.",2021,"This method of analgesic delivery also has the potential to reduce preoperative anxiety, alleviate the burden of pain management and minimise opioid use.","['participants who completed 5-day postoperative follow-up, were able and willing to participate in a face-to-face interview, and had consented to be contacted, were eligible to take part in the qualitative study', 'Interview participants were patients enrolled in', ""patients' experiences of analgesia after major lower limb amputation"", 'Participants were recruited from two general hospitals in South Wales', 'A total of 20 interviews were conducted with 14 participants: 10 male and 4 female']","['PLACEMENT (Perineural Local Anaesthetic Catheter', 'perineural catheter (PNC) versus standard care for postoperative pain relief following major lower limb amputation']","['postoperative pain relief', 'postoperative pain', 'pain relief medication']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0949415', 'cui_str': 'Qualitative Research'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",20.0,0.063697,"This method of analgesic delivery also has the potential to reduce preoperative anxiety, alleviate the burden of pain management and minimise opioid use.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Milosevic', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK milosevics@cardiff.ac.uk.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Strange', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Graeme K', 'Initials': 'GK', 'LastName': 'Ambler', 'Affiliation': 'Department of General Surgery, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Bosanquet', 'Affiliation': 'Gwent Vascular Institute, Royal Gwent Hospital, Aneurin Bevan University Health Board, Newport, UK.'}, {'ForeName': 'Cherry-Ann', 'Initials': 'CA', 'LastName': 'Waldron', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Thomas-Jones', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Harris', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Twine', 'Affiliation': 'Department of General Surgery, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brookes-Howell', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}]",BMJ open,['10.1136/bmjopen-2021-054618']
1360,34998000,"Comparative study between intralesional injection of MMR, BCG, and candida albicans antigen in treatment of multiple recalcitrant warts.","BACKGROUND


Cutaneous warts represent a challenging condition to treat.
OBJECTIVE


To evaluate the safety and efficacy of intralesional injection of MMR (mumps, measles, and rubella) antigen, BCG (bacillus Calmette-Guerin) vaccine, and candida antigen for the treatment of multiple warts.
METHODS


A total of ninety (90) clinically confirmed adult patients complaining of recalcitrant extragenital warts of various sizes and durations were recruited in this randomized clinical trial. They were divided into three groups (A, B, and C). Each group consisted of (30) patients. Group (A) subjects received intralesional MMR injections. Group (B) subjects received intralesional BCG injection and Group (C) received intralesional candida antigen injection.
RESULTS


Full clearance of warts was observed in (73.33%, 70%, and 43.33%) in groups A, B, and C, respectively. Infrequent side effects including pain, erythema, and minimal induration were reported in all groups but did not necessitate termination of treatment.
CONCLUSION


All the three modalities used demonstrated a simple, safe modality with low adverse events, and with no recurrence. To achieve an optimal response with an ideal immunotherapeutic agent and ideal dose, further comparative studies are warranted and on different populations and larger sample sizes.",2022,"Infrequent side effects including pain, erythema, and minimal induration were reported in all groups but did not necessitate termination of treatment.
","['multiple warts', 'A total of ninety (90) clinically confirmed adult patients complaining of recalcitrant extragenital warts of various sizes and durations', 'multiple recalcitrant warts']","['intralesional MMR injections', 'intralesional BCG injection', 'intralesional injection of MMR (mumps, measles, and rubella) antigen, BCG (bacillus Calmette-Guerin) vaccine', 'intralesional injection of MMR, BCG, and candida albicans antigen', 'intralesional candida antigen injection']","['pain, erythema, and minimal induration', 'Full clearance of warts', 'safety and efficacy']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0021490', 'cui_str': 'Intralesional injection'}, {'cui': 'C0025007', 'cui_str': 'Measles'}, {'cui': 'C0035920', 'cui_str': 'Rubella'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0006837', 'cui_str': 'Candida albicans'}, {'cui': 'C0006836', 'cui_str': 'Candida'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0332534', 'cui_str': 'Induration'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",90.0,0.104834,"Infrequent side effects including pain, erythema, and minimal induration were reported in all groups but did not necessitate termination of treatment.
","[{'ForeName': 'Ramadan Mohamed', 'Initials': 'RM', 'LastName': 'Eldahshan', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Al-Azhar University, Damietta, Egypt.'}, {'ForeName': 'Walaa Mohamed Omar', 'Initials': 'WMO', 'LastName': 'Ashry', 'Affiliation': 'Medical Microbiology and Immunology Department, Damietta Faculty of Medicine (Girls), Al-Azhar University, Damietta, Egypt.'}, {'ForeName': 'Mohamed L', 'Initials': 'ML', 'LastName': 'Elsaie', 'Affiliation': 'Department of Dermatology, Medical Research and Clinical Studies Institute- National Research Centre, Cairo, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14737']
1361,34883053,"Immunogenicity, safety, and reactogenicity of heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines in the UK (Com-COV2): a single-blind, randomised, phase 2, non-inferiority trial.","BACKGROUND


Given the importance of flexible use of different COVID-19 vaccines within the same schedule to facilitate rapid deployment, we studied mixed priming schedules incorporating an adenoviral-vectored vaccine (ChAdOx1 nCoV-19 [ChAd], AstraZeneca), two mRNA vaccines (BNT162b2 [BNT], Pfizer-BioNTech, and mRNA-1273 [m1273], Moderna) and a nanoparticle vaccine containing SARS-CoV-2 spike glycoprotein and Matrix-M adjuvant (NVX-CoV2373 [NVX], Novavax).
METHODS


Com-COV2 is a single-blind, randomised, non-inferiority trial in which adults aged 50 years and older, previously immunised with a single dose of ChAd or BNT in the community, were randomly assigned (in random blocks of three and six) within these cohorts in a 1:1:1 ratio to receive a second dose intramuscularly (8-12 weeks after the first dose) with the homologous vaccine, m1273, or NVX. The primary endpoint was the geometric mean ratio (GMR) of serum SARS-CoV-2 anti-spike IgG concentrations measured by ELISA in heterologous versus homologous schedules at 28 days after the second dose, with a non-inferiority criterion of the GMR above 0·63 for the one-sided 98·75% CI. The primary analysis was on the per-protocol population, who were seronegative at baseline. Safety analyses were done for all participants who received a dose of study vaccine. The trial is registered with ISRCTN, number 27841311.
FINDINGS


Between April 19 and May 14, 2021, 1072 participants were enrolled at a median of 9·4 weeks after receipt of a single dose of ChAd (n=540, 47% female) or BNT (n=532, 40% female). In ChAd-primed participants, geometric mean concentration (GMC) 28 days after a boost of SARS-CoV-2 anti-spike IgG in recipients of ChAd/m1273 (20 114 ELISA laboratory units [ELU]/mL [95% CI 18 160 to 22 279]) and ChAd/NVX (5597 ELU/mL [4756 to 6586]) was non-inferior to that of ChAd/ChAd recipients (1971 ELU/mL [1718 to 2262]) with a GMR of 10·2 (one-sided 98·75% CI 8·4 to ∞) for ChAd/m1273 and 2·8 (2·2 to ∞) for ChAd/NVX, compared with ChAd/ChAd. In BNT-primed participants, non-inferiority was shown for BNT/m1273 (GMC 22 978 ELU/mL [95% CI 20 597 to 25 636]) but not for BNT/NVX (8874 ELU/mL [7391 to 10 654]), compared with BNT/BNT (16 929 ELU/mL [15 025 to 19 075]) with a GMR of 1·3 (one-sided 98·75% CI 1·1 to ∞) for BNT/m1273 and 0·5 (0·4 to ∞) for BNT/NVX, compared with BNT/BNT; however, NVX still induced an 18-fold rise in GMC 28 days after vaccination. There were 15 serious adverse events, none considered related to immunisation.
INTERPRETATION


Heterologous second dosing with m1273, but not NVX, increased transient systemic reactogenicity compared with homologous schedules. Multiple vaccines are appropriate to complete primary immunisation following priming with BNT or ChAd, facilitating rapid vaccine deployment globally and supporting recognition of such schedules for vaccine certification.
FUNDING


UK Vaccine Task Force, Coalition for Epidemic Preparedness Innovations (CEPI), and National Institute for Health Research. NVX vaccine was supplied for use in the trial by Novavax.",2022,"In BNT-primed participants, non-inferiority was shown for BNT/m1273 (GMC 22 ","['adults aged 50 years and older, previously immunised with a single dose of ChAd or BNT in the community', '1718 to 2262]) with a GMR of 10·2', '1072 participants were enrolled at a median of 9·4 weeks after receipt of a single dose of ChAd (n=540, 47% female) or BNT (n=532, 40% female', 'Between April 19 and May 14, 2021']","['BNT/BNT', 'homologous vaccine, m1273, or NVX', 'heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines', 'NVX vaccine']","['geometric mean ratio (GMR) of serum SARS-CoV-2 anti-spike IgG concentrations', 'Immunogenicity, safety, and reactogenicity', 'transient systemic reactogenicity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0007928', 'cui_str': 'Chad'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439860', 'cui_str': 'Heterologous'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]",1072.0,0.627829,"In BNT-primed participants, non-inferiority was shown for BNT/m1273 (GMC 22 ","[{'ForeName': 'Arabella S V', 'Initials': 'ASV', 'LastName': 'Stuart', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Shaw', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Xinxue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Greenland', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Parvinder K', 'Initials': 'PK', 'LastName': 'Aley', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nick J', 'Initials': 'NJ', 'LastName': 'Andrews', 'Affiliation': 'Statistics, Modelling and Economics Department, UK Health Security Agency, London, UK; Immunisation and Countermeasures Division, National Infection Service, UK Health Security Agency, London, UK.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Cameron', 'Affiliation': 'Public Health Scotland, Glasgow, Scotland, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Charlton', 'Affiliation': 'UK Health Security Agency, Porton Down, Salisbury, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Clutterbuck', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Collins', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Darton', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK; Department of Infection and Tropical Medicine, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Dinesh', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher J A', 'Initials': 'CJA', 'LastName': 'Duncan', 'Affiliation': 'The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Translational and Clinical Research Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'England', 'Affiliation': 'UK Health Security Agency, Porton Down, Salisbury, UK.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Daniela M', 'Initials': 'DM', 'LastName': 'Ferreira', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Finn', 'Affiliation': 'School of Population Health Sciences, and School of Cellular and Molecular Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Goodman', 'Affiliation': ""Department of Infection, and NIHR BRC, Guy's and St Thomas' NHS Foundation Trust, London, UK; MRC Clinical Trials Unit, University College London, London, UK.""}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Green', 'Affiliation': 'NIHR/Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Institute of Microbiology and Infection, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Hallis', 'Affiliation': 'UK Health Security Agency, Porton Down, Salisbury, UK.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Heath', 'Affiliation': ""The Vaccine Institute, St George's University of London, London, UK.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Bryn M', 'Initials': 'BM', 'LastName': 'Horsington', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; Chinese Academy of Medical, Science Oxford Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rajeka', 'Initials': 'R', 'LastName': 'Lazarus', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Libri', 'Affiliation': 'NIHR UCLH Clinical Research Facility and NIHR UCLH Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Lillie', 'Affiliation': 'Infection Research Group, Hull University Teaching Hospitals NHS Trust, Hull, UK.'}, {'ForeName': 'Yama F', 'Initials': 'YF', 'LastName': 'Mujadidi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Payne', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK; Department of Infection and Tropical Medicine, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Plested', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Provstgaard-Morys', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Maheshi N', 'Initials': 'MN', 'LastName': 'Ramasamy', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ramsay', 'Affiliation': 'Immunisation and Countermeasures Division, National Infection Service, UK Health Security Agency, London, UK.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Read', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gavin R', 'Initials': 'GR', 'LastName': 'Screaton', 'Affiliation': 'Chinese Academy of Medical, Science Oxford Institute, University of Oxford, Oxford, UK; Wellcome Centre for Human Genetics, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'David P J', 'Initials': 'DPJ', 'LastName': 'Turner', 'Affiliation': 'University of Nottingham, Nottingham, UK; Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Turner', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Iason', 'Initials': 'I', 'LastName': 'Vichos', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'White', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Nguyen-Van-Tam', 'Affiliation': 'Division of Epidemiology and Public Health, University of Nottingham School of Medicine, Nottingham, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; Oxford NIHR-Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK. Electronic address: matthew.snape@paediatrics.ox.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)02718-5']
1362,34895109,"Lacticaseibacillus rhamnosus  GG DSM 33156 effects on pathogen defence in the upper respiratory tract: a randomised, double-blind, placebo-controlled paediatric trial.","Acute upper respiratory tract infections (URTIs) are caused by numerous viruses and bacteria. URTIs can be a cause of morbidity and are among the most common reasons for visiting healthcare practitioners and prescribing antibiotics to children in addition to causing absenteeism from school and work. Oral intake of  Lacticaseibacillus rhamnosus  GG DSM 33156 has shown beneficial health effects in several clinical trials, primarily relating to immune function and gastrointestinal health in children and adults. It has also been suggested that oral intake of  L. rhamnosus  GG DSM 33156 can reduce the incidence rate and alleviate symptoms of URTIs in children. We here report the results of a randomised, double-blind, placebo-controlled trial of 619 children aged 2-6 years conducted at a single centre in Scotland. The children, who were in day care or primary school, were followed over a 16-week intervention period with 309 randomised in the active group and 310 in the placebo group. The parents or guardians reported a daily healthcare status and any presumed episodes of URTI, which were subsequently confirmed by a general practitioner. The investigational product was well tolerated in the trial. Although a general trend towards a beneficial effect was observed, this trial did not demonstrate that  L. rhamnosus  GG DSM 33156 significantly reduced the incidence of URTIs, diagnosed by a general practitioner according to prespecified criteria (primary endpoint). Moreover, none of the secondary efficacy endpoints were met. Applying a Ward's hierarchical clustering, two separate clusters, focussing on four quality of life-related endpoints, were identified. Cluster 1 was associated with more severe URTI characteristics than cluster 2. Cluster 2 was significantly enriched with children who consumed the product, indicating that the symptoms children experience during an URTI are alleviated by the intake of  L. rhamnosus  GG DSM 33156. The study is registered at ClinicalTrials.gov ID: NCT03636191.",2022,Cluster 1 was associated with more severe URTI characteristics than cluster 2.,"['619 children aged 2-6 years conducted at a single centre in Scotland', 'upper respiratory tract', 'children, who were in day care or primary school, were followed over a 16-week intervention period with 309 randomised in the active group and 310 in the', 'children and adults']","['placebo', 'Lacticaseibacillus rhamnosus  GG DSM']","['incidence rate and alleviate symptoms of URTIs', 'severe URTI characteristics']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0458578', 'cui_str': 'Upper respiratory tract structure'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",619.0,0.312754,Cluster 1 was associated with more severe URTI characteristics than cluster 2.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Damholt', 'Affiliation': 'Chr. Hansen A/S, Kogle allé 6, Hørsholm 2970, Denmark.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Keller', 'Affiliation': 'Chr. Hansen A/S, Kogle allé 6, Hørsholm 2970, Denmark.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Baranowski', 'Affiliation': 'CPS Research, 3 Acre Road, Todd Campus, Glasgow G20 0XA, United Kingdom.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brown', 'Affiliation': 'CPS Research, 3 Acre Road, Todd Campus, Glasgow G20 0XA, United Kingdom.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wichmann', 'Affiliation': 'Chr. Hansen A/S, Kogle allé 6, Hørsholm 2970, Denmark.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Melsaether', 'Affiliation': 'Chr. Hansen A/S, Kogle allé 6, Hørsholm 2970, Denmark.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Eskesen', 'Affiliation': 'Chr. Hansen A/S, Kogle allé 6, Hørsholm 2970, Denmark.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Westphal', 'Affiliation': 'Chr. Hansen A/S, Kogle allé 6, Hørsholm 2970, Denmark.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Arltoft', 'Affiliation': 'Chr. Hansen A/S, Kogle allé 6, Hørsholm 2970, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Habicht', 'Affiliation': 'Signifikans Aps, Bygstubben 16, Vedbæk 2950, Denmark.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Signifikans Aps, Bygstubben 16, Vedbæk 2950, Denmark.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Crawford', 'Affiliation': 'CPS Research, 3 Acre Road, Todd Campus, Glasgow G20 0XA, United Kingdom.'}]",Beneficial microbes,['10.3920/BM2021.0065']
1363,34895700,"Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain compared with leuprorelin in Japanese women: a phase 3, randomized, double-blind, noninferiority study.","OBJECTIVE


To evaluate the efficacy and safety of 40-mg relugolix (REL) compared with those of leuprorelin (LEU) in women with endometriosis-associated pain.
DESIGN


Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study in Japanese patients.
SETTING


Hospitals and clinics.
PATIENT(S)


Women aged ≥20 years with regular menstrual cycles (25-38 days) experiencing endometriosis or ovarian endometrioma and reporting pelvic pain.
INTERVENTION(S)


In the REL group, 40 mg of REL was orally administered once a day for 24 weeks. In the LEU group, 3.75 or 1.88 mg of LEU was subcutaneously injected every 4 weeks for 24 weeks.
MAIN OUTCOME MEASURE(S)


The primary endpoint was the change in the maximum visual analog scale score for pelvic pain from baseline until 28 days before the end of treatment.
RESULT(S)


Changes in the maximum visual analog scale score were -52.6 ± 1.3 for REL and -57.5 ± 1.4 for LEU. Ovarian endometrioma decreased by 12.26 ± 17.52 cm 3  for REL and 14.10 ± 18.81 cm 3  for LEU. Drug-related treatment emergent adverse events with an incidence of >10% for both groups were hot flush, metrorrhagia, headache, and genital hemorrhage. Discontinuations from treatment emergent adverse events were 2.9% for REL and 4.3% for LEU.
CONCLUSION(S)


Relugolix was noninferior to LEU for treating endometriosis-associated pelvic pain. Safety profiles of both medications were comparable, although menses returned earlier in patients taking REL, a huge benefit for women who plan to conceive after treatment.
CLINICAL TRIAL REGISTRATION NUMBER


ClinicalTrials.gov: NCT03931915.",2022,"Drug-related treatment emergent adverse events with an incidence of >10% for both groups were hot flush, metrorrhagia, headache, and genital hemorrhage.","['Hospitals and clinics', 'women with endometriosis-associated pain', 'Japanese patients', '\n\n\nWomen aged ≥20 years with regular menstrual cycles (25-38 days) experiencing endometriosis or ovarian endometrioma and reporting pelvic pain', 'Japanese women']","['leuprorelin (LEU', 'LEU', 'REL', '40-mg relugolix (REL', 'Relugolix, an oral gonadotropin-releasing hormone receptor antagonist']","['maximum visual analog scale score', 'metrorrhagia, headache, and genital hemorrhage', 'efficacy and safety', 'Ovarian endometrioma', 'maximum visual analog scale score for pelvic pain']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0269102', 'cui_str': 'Endometriotic cyst'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}]","[{'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0025874', 'cui_str': 'Intermenstrual bleeding - irregular'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0854381', 'cui_str': 'Genital haemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0269102', 'cui_str': 'Endometriotic cyst'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}]",,0.786057,"Drug-related treatment emergent adverse events with an incidence of >10% for both groups were hot flush, metrorrhagia, headache, and genital hemorrhage.","[{'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Department of Obstetrics and Gynecology, Tottori University Faculty of Medicine, Yonago, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Osuga', 'Affiliation': 'Obstetrics and Gynecology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Clinical Development Department, ASKA Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Fujisawa', 'Affiliation': 'Clinical Development Department, ASKA Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Fukui', 'Affiliation': 'Medical Affairs Department, ASKA Pharmaceutical Co., Ltd., Tokyo, Japan. Electronic address: fukui-m@aska-pharma.co.jp.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Kitawaki', 'Affiliation': 'Department of Obstetrics and Gynecology, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan.'}]",Fertility and sterility,['10.1016/j.fertnstert.2021.11.013']
1364,34896605,Robot-assisted gait training with auditory and visual cues in Parkinson's disease: A randomized controlled trial.,"BACKGROUND


Robot-assisted gait training (RAGT) may have beneficial effects on Parkinson's disease (PD); however, the evidence to date is inconsistent.
OBJECTIVES


This study compared the effects of RAGT and treadmill training (TT) on gait speed, dual-task gait performance, and changes in resting-state brain functional connectivity in individuals with PD.
METHODS


In this prospective, single-center, randomized controlled trial with a parallel two-group design, 44 participants were randomly allocated to undergo 12 sessions (3 times per week for 4 weeks) of RAGT or TT. The primary outcome was gait speed on the 10-m walk test (10mWT) under comfortable walking conditions. Secondary outcomes included dual-task interference on gait speed, balance, disability scores, fear of falling, freezing of gait, and brain functional connectivity changes. All clinical outcomes were measured before (T0), immediately after (T1), and 1 month after treatment (T2).
RESULTS


The mean (SD) age of the participants was 68.1 (8.1) years, and mean disease duration 108.0 (61.5) months. The groups did not significantly differ on the 10mWT (T0-T1, p = 0.726, Cohen's d = 0.133; T0-T2, p = 0.778, Cohen's d = 0.121). We observed a significant time-by-group interaction (F = 3.236, p = 0.045) for cognitive dual-task interference, controlling for confounders. After treatment, coupling was decreased to a greater extent with RAGT than TT between the visual and dorsal attention networks (p = 0.015), between bilateral fronto-parietal networks (p = 0.043), and between auditory and medial temporal networks (p = 0.018). Improvement in cognitive dual-task interference was positively correlated with enhanced visual and medial temporal network coupling overall (r = 0.386, p = 0.029) and with TT (r = 0.545, p = 0.024) but not RAGT (r = 0.151, p = 0.590).
CONCLUSIONS


RAGT was not superior to intensity-matched TT on improving gait functions in individuals with PD but may be beneficial in improving gait ability under cognitive dual-task conditions. The therapeutic mechanism and key functional connectivity changes associated with improvement may differ between treatment strategies. CLINICALTRIALS.GOV: #NCT03490578.",2022,The groups did not significantly differ on the 10mWT,"[""Parkinson's disease"", ""Parkinson's disease (PD"", 'individuals with PD', '44 participants']","['RAGT and treadmill training (TT', 'Robot-assisted gait training with auditory and visual cues', 'Robot-assisted gait training (RAGT', 'RAGT or TT']","['visual and dorsal attention networks', 'dual-task interference on gait speed, balance, disability scores, fear of falling, freezing of gait, and brain functional connectivity changes', 'auditory and medial temporal networks', 'gait speed, dual-task gait performance', 'gait functions', 'gait speed on the 10-m walk test (10mWT) under comfortable walking conditions', 'enhanced visual and medial temporal network coupling overall', 'cognitive dual-task interference']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",44.0,0.11606,The groups did not significantly differ on the 10mWT,"[{'ForeName': 'Heejae', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Eunkyung', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea; Biomedical Research Institute, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Seo Jung', 'Initials': 'SJ', 'LastName': 'Yun', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Min-Gu', 'Initials': 'MG', 'LastName': 'Kang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Dong-A University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Hyun Iee', 'Initials': 'HI', 'LastName': 'Shin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Byung-Mo', 'Initials': 'BM', 'LastName': 'Oh', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Han Gil', 'Initials': 'HG', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea. Electronic address: hangilseo@snu.ac.kr.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2021.101620']
1365,34903039,Effect of the Glucagon-Like Peptide-1 Receptor Agonists Semaglutide and Liraglutide on Kidney Outcomes in Patients With Type 2 Diabetes: Pooled Analysis of SUSTAIN 6 and LEADER.,"BACKGROUND


We assessed the effect of once-weekly semaglutide and once-daily liraglutide on kidney outcomes in type 2 diabetes.
METHODS


Pooled (n=12 637) and by-trial data from SUSTAIN 6 (Trial to Evaluate Cardiovascular and Other Long-Term Outcomes With Semaglutide in Subjects With Type 2 Diabetes; n=3297) and LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results; n=9340) were assessed for albuminuria change, annual slope of estimated glomerular filtration rate (eGFR) change, and time to persistent eGFR reduction (30%, 40%, 50%, and 57%) from baseline.
RESULTS


The median follow-up durations were 2.1 years for SUSTAIN 6 and 3.8 years for LEADER. In the pooled analysis, semaglutide/liraglutide lowered albuminuria from baseline to 2 years after randomization by 24% versus placebo (95% CI, 20%-27%;  P <0.001). Significant reductions were also observed in by-trial data analyses ( P <0.001 for all), the largest being with semaglutide 1.0 mg (33% [95% CI, 24%-40%];  P <0.001) at 2 years. With semaglutide 1.0 mg and liraglutide, eGFR slope decline was significantly slowed by 0.87 and 0.26 mL/min/1.73 m 2 /y ( P <0.0001 and  P <0.001), respectively, versus placebo. Effects appeared larger in patients with baseline eGFR <60 versus ≥60 mL/min/1.73 m 2  ( P interaction =0.06 and 0.008 for semaglutide 1.0 mg and liraglutide, respectively). Semaglutide/liraglutide significantly lowered risk of persistent 40% and 50% eGFR reductions versus placebo (hazard ratio [HR], 0.86 [95% CI, 0.75-0.99];  P =0.039 and HR, 0.80 [95% CI, 0.66-0.97];  P =0.023, respectively). Similar, nonsignificant, directional results were observed for 30% and 57% eGFR reductions (HR, 0.92 [95% CI, 0.84-1.02];  P =0.10 and HR, 0.89 [95% CI, 0.69-1.13];  P =0.34). In patients with baseline eGFR 30 to <60 mL/min/1.73 m 2 , the likelihood of persistent reduction for all thresholds was increased, ranging from HR 0.71 for 30% reduction (95% CI, 0.59-0.85;  P =0.0003,  P interaction =0.017) to 0.54 for 57% reduction (95% CI, 0.36-0.81;  P =0.003,  P interaction =0.035).
CONCLUSIONS


In patients with type 2 diabetes, semaglutide/liraglutide offered kidney-protective effects, which appeared more pronounced in patients with preexisting chronic kidney disease.",2022,"Significant reductions were also observed in by-trial data analyses ( p <0.001 for all), the largest being with semaglutide 1.0 mg: 33% (95% CI [24%,40% ],  p <0.001) at 2 years.","['Patients With Type 2 Diabetes', 'type 2 diabetes (T2D']","['placebo', 'Semaglutide/liraglutide', 'Glucagon-like Peptide-1 Receptor Agonists Semaglutide and Liraglutide', 'liraglutide']","['albuminuria change, annual slope of estimated glomerular filtration rate (eGFR) change, and time to persistent eGFR reduction', 'Kidney Outcomes', 'kidney-protective effects', 'kidney outcomes', 'eGFR slope decline']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",9340.0,0.441433,"Significant reductions were also observed in by-trial data analyses ( p <0.001 for all), the largest being with semaglutide 1.0 mg: 33% (95% CI [24%,40% ],  p <0.001) at 2 years.","[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Shaman', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Australia (A.M.S.).'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Institute of Life Science, Swansea University Medical School, Singleton Hospital, Swansea, United Kingdom (S.C.B.).'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Bakris', 'Affiliation': 'University of Chicago Medicine, IL (G.L.B.).'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill (J.B.B.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark (T.I., S.R., B.W.).'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research (SCCR), Department of Medicine, Stanford School of Medicine, CA (K.W.M.).'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Center, Munich, Germany (J.F.E.M.).'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Division, Katholisches Klinikum Bochum, St Josef Hospital (Ruhr-Universität Bochum), Bochum, Germany (M.A.N.).'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark (T.I., S.R., B.W.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark (P.R.).'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Wolthers', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark (T.I., S.R., B.W.).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mt Sinai Hospital, University of Toronto, Canada (B.Z.).'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia (A.M.S., V.P.).'}]",Circulation,['10.1161/CIRCULATIONAHA.121.055459']
1366,34801112,"Safety and efficacy of a three-dose regimen of Plasmodium falciparum sporozoite vaccine in adults during an intense malaria transmission season in Mali: a randomised, controlled phase 1 trial.","BACKGROUND


WHO recently approved a partially effective vaccine that reduces clinical malaria in children, but increased vaccine activity is required to pursue malaria elimination. A phase 1 clinical trial was done in Mali, west Africa, to assess the safety, immunogenicity, and protective efficacy of a three-dose regimen of Plasmodium falciparum sporozoite (PfSPZ) Vaccine (a metabolically active, non-replicating, whole malaria sporozoite vaccine) against homologous controlled human malaria infection (CHMI) and natural P falciparum infection.
METHODS


We recruited healthy non-pregnant adults aged 18-50 years in Donéguébougou, Mali, and surrounding villages (Banambani, Toubana, Torodo, Sirababougou, Zorokoro) for an open-label, dose-escalation pilot study and, thereafter, a randomised, double-blind, placebo-controlled main trial. Pilot study participants were enrolled on an as-available basis to one group of CHMI infectivity controls and three staggered vaccine groups receiving: one dose of 4·5 × 10 5 , one dose of 9 × 10 5 , or three doses of 1·8 × 10 6  PfSPZ via direct venous inoculation at approximately 8 week intervals, followed by homologous CHMI 5 weeks later with infectious PfSPZ by direct venous inoculation (PfSPZ Challenge). Main cohort participants were stratified by village and randomly assigned (1:1) to receive three doses of 1·8 × 10 6  PfSPZ or normal saline at 1, 13, and 19 week intervals using permuted block design by the study statistician. The primary outcome was safety and tolerability of at least one vaccine dose; the secondary outcome was vaccine efficacy against homologous PfSPZ CHMI (pilot study) or against naturally transmitted P falciparum infection (main study) measured by thick blood smear. Combined artesunate and amodiaquine was administered to eliminate pre-existing parasitaemia. Outcomes were analysed by modified intention to treat (mITT; including all participants who received at least one dose of investigational product; safety and vaccine efficacy) and per protocol (vaccine efficacy). This trial is registered with ClinicalTrials.gov, number NCT02627456.
FINDINGS


Between Dec 20, 2015, and April 30, 2016, we enrolled 56 participants into the pilot study (five received the 4·5 × 10 5  dose, five received 9 × 10 5 , 30 received 1·8 × 10 6 , 15 were CHMI controls, and one withdrew before vaccination) and 120 participants into the main study cohort with 60 participants assigned PfSPZ Vaccine and 60 placebo in the main study. Adverse events and laboratory abnormalities post-vaccination in all dosing groups were few, mainly mild, and did not differ significantly between vaccine groups (all p>0·05). Unexpected severe transaminitis occured in four participants: one participant in pilot phase that received 1·8 × 10 6  PfSPZ Vaccine, one participant in main phase that received 1·8 × 10 6  PfSPZ Vaccine, and two participants in the main phase placebo group. During PfSPZ CHMI, approximately 5 weeks after the third dose of 1·8 × 10 6  PfSPZ, none of 29 vaccinees and one of 15 controls became positive on thick blood smear; subsequent post-hoc PCR analysis for submicroscopic blood stage infections detected P falciparum parasites in none of the 29 vaccine recipients and eight of 15 controls during CHMI. In the main trial, 32 (58%) of 55 vaccine recipients and 42 (78%) of 54 controls became positive on thick blood smear during 24-week surveillance after vaccination. Vaccine efficacy (1-hazard ratio) was 0·51 per protocol (95% CI 0·20-0·70; log-rank p=0·0042) and 0·39 by mITT (0·04-0·62; p=0·033); vaccine efficacy (1-risk ratio) was 0·24 per-protocol (0·02-0·41; p=0·031) and 0·22 mITT (0·01-0·39; p=0·041).
INTERPRETATION


A three-dose regimen of PfSPZ Vaccine was safe, well tolerated, and conferred 51% vaccine efficacy against intense natural P falciparum transmission, similar to 52% vaccine efficacy reported for a five-dose regimen in a previous trial.
FUNDING


US National Institute of Allergy and Infectious Diseases, National Institutes of Health, Sanaria.
TRANSLATION


For the French translation of the abstract see Supplementary Materials section.",2022,"Adverse events and laboratory abnormalities post-vaccination in all dosing groups were few, mainly mild, and did not differ significantly between vaccine groups (all p>0·05).","['Pilot study participants were enrolled on an as-available basis to one group of CHMI infectivity controls and three staggered', 'Between Dec 20, 2015, and April 30, 2016, we enrolled 56 participants into the pilot study (five received the 4·5\u2009×\u200910 5  dose, five received 9\u2009×\u200910 5 , 30 received 1·8\u2009×\u200910 6 , 15 were CHMI controls, and one withdrew before vaccination) and 120 participants into the main study cohort with 60 participants assigned', 'recruited healthy non-pregnant adults aged 18-50 years in Donéguébougou, Mali, and surrounding villages (Banambani, Toubana, Torodo, Sirababougou, Zorokoro) for an open-label, dose-escalation pilot study and, thereafter', 'adults during an intense malaria transmission season in Mali']","['vaccine groups receiving: one dose of 4·5\u2009×\u200910 5 , one dose of 9\u2009×\u200910 5 , or three doses of 1·8', 'PfSPZ Vaccine', 'PfSPZ or normal saline', 'Plasmodium falciparum sporozoite vaccine', 'PfSPZ Vaccine and 60 placebo', 'Plasmodium falciparum sporozoite (PfSPZ) Vaccine', 'placebo', 'PfSPZ Vaccine, one participant in main phase that received 1·8\u2009×\u200910 6  PfSPZ Vaccine', 'Combined artesunate and amodiaquine']","['vaccine efficacy against homologous PfSPZ CHMI (pilot study) or against naturally transmitted P falciparum infection (main study) measured by thick blood smear', 'Adverse events and laboratory abnormalities post-vaccination', 'vaccine efficacy', 'Vaccine efficacy (1-hazard ratio', 'thick blood smear', 'Safety and efficacy', 'safety, immunogenicity, and protective efficacy', 'safety and tolerability']","[{'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0030657', 'cui_str': 'pathogenicity'}, {'cui': 'C0344191', 'cui_str': 'Cerebellar decompression injury'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0205451', 'cui_str': '5'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0562648', 'cui_str': 'Kingdom Protozoa sporozoite'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1869889', 'cui_str': 'artesunate and amodiaquine'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0562648', 'cui_str': 'Kingdom Protozoa sporozoite'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0858318', 'cui_str': 'Plasmodium falciparum infection'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",56.0,0.779485,"Adverse events and laboratory abnormalities post-vaccination in all dosing groups were few, mainly mild, and did not differ significantly between vaccine groups (all p>0·05).","[{'ForeName': 'Mahamadou S', 'Initials': 'MS', 'LastName': 'Sissoko', 'Affiliation': 'Malaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Healy', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Katile', 'Affiliation': 'Malaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Zaidi', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Zonghui', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Biostatistical Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bourama', 'Initials': 'B', 'LastName': 'Kamate', 'Affiliation': 'Malaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Yacouba', 'Initials': 'Y', 'LastName': 'Samake', 'Affiliation': 'Malaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Kourane', 'Initials': 'K', 'LastName': 'Sissoko', 'Affiliation': 'Malaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Mwakingwe-Omari', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA; Center for Vaccine Research, GlaxoSmithKline, Rockville, MD, USA.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Lane', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alemush', 'Initials': 'A', 'LastName': 'Imeru', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Rathy', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ismaila', 'Initials': 'I', 'LastName': 'Thera', 'Affiliation': 'Malaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Cheick Oumar', 'Initials': 'CO', 'LastName': 'Guindo', 'Affiliation': 'Malaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Amagana', 'Initials': 'A', 'LastName': 'Dolo', 'Affiliation': 'Malaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Karamoko', 'Initials': 'K', 'LastName': 'Niare', 'Affiliation': 'Malaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Fanta', 'Initials': 'F', 'LastName': 'Koïta', 'Affiliation': 'Malaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Niangaly', 'Affiliation': 'Malaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Rausch', 'Affiliation': 'Malaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Amatigue', 'Initials': 'A', 'LastName': 'Zeguime', 'Affiliation': 'Malaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Merepen A', 'Initials': 'MA', 'LastName': 'Guindo', 'Affiliation': 'Malaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Aissatou', 'Initials': 'A', 'LastName': 'Bah', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA; Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Yonas', 'Initials': 'Y', 'LastName': 'Abebe', 'Affiliation': 'Sanaria, Rockville, MD, USA.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'James', 'Affiliation': 'Sanaria, Rockville, MD, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Manoj', 'Affiliation': 'Sanaria, Rockville, MD, USA.'}, {'ForeName': 'Tooba', 'Initials': 'T', 'LastName': 'Murshedkar', 'Affiliation': 'Sanaria, Rockville, MD, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Kc', 'Affiliation': 'Sanaria, Rockville, MD, USA; Protein Potential, Rockville, MD, USA.'}, {'ForeName': 'B Kim Lee', 'Initials': 'BKL', 'LastName': 'Sim', 'Affiliation': 'Sanaria, Rockville, MD, USA; Protein Potential, Rockville, MD, USA.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Billingsley', 'Affiliation': 'Sanaria, Rockville, MD, USA.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Richie', 'Affiliation': 'Sanaria, Rockville, MD, USA.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria, Rockville, MD, USA.'}, {'ForeName': 'Ogobara', 'Initials': 'O', 'LastName': 'Doumbo', 'Affiliation': 'Malaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Patrick E', 'Initials': 'PE', 'LastName': 'Duffy', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. Electronic address: patrick.duffy@nih.gov.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(21)00332-7']
1367,34809581,"Intubation using VieScope vs. Video laryngoscopy in full personal protective equipment - a randomized, controlled simulation trial.","BACKGROUND


VieScope is a new type of laryngoscope, with a straight, transparent and illuminated blade, allowing for direct line of sight towards the larynx. In addition, VieScope is disposed of after single patient use, which can avoid cross-contaminations of contagious material. This has gained importance especially when treating patients with highly contagious infectious diseases, such as during the SARS-CoV2 pandemic. In this context, VieScope has not been evaluated yet in a clinical study.
MATERIAL AND METHODS


This study compared intubation with VieScope to video-laryngoscopy (GlideScope) in normal and difficult airway in a standardized airway manikin in a randomized controlled simulation trial. Thirty-five medical specialists were asked to perform endotracheal intubation in full personal protective equipment (PPE). Primary endpoint was correct tube position. First-pass rate (i.e., success rate at the first attempt), time until intubation and time until first correct ventilation were registered as secondary endpoints.
RESULTS


For correct tracheal tube placement, there was no significant difference between VieScope and GlideScope in normal and difficult airway conditions. VieScope had over 91% fist-pass success rate in normal airway setting. VieScope had a comparable success rate to GlideScope in difficult airway, but had a significantly longer time until intubation and time until ventilation.
CONCLUSION


VieScope and GlideScope had high success rates in normal as well as in difficult airway. There was no unrecognized esophageal intubation in either group. Overall time for intubation was longer in the VieScope group, though in an acceptable range given in literature. Results from this simulation study suggest that VieScope may be an acceptable alternative for tracheal intubation in full PPE.
TRIAL REGISTRATION


The study was registered at the German Clinical Trials Register www.drks.de (Registration date: 09/11/2020; TrialID: DRKS00023406 ).",2021,"VieScope had a comparable success rate to GlideScope in difficult airway, but had a significantly longer time until intubation and time until ventilation.
","['patients with highly contagious infectious diseases', 'Thirty-five medical specialists']","['intubation with VieScope to video-laryngoscopy (GlideScope', 'VieScope vs. Video laryngoscopy', 'endotracheal intubation in full personal protective equipment (PPE']","['time until intubation and time until first correct ventilation', 'unrecognized esophageal intubation', 'longer time until intubation and time until ventilation', 'correct tube position', 'Overall time for intubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0192301', 'cui_str': 'Insertion of catheter into esophagus, permanent tube type'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",35.0,0.0359151,"VieScope had a comparable success rate to GlideScope in difficult airway, but had a significantly longer time until intubation and time until ventilation.
","[{'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Ecker', 'Affiliation': 'Faculty of Medicine, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kolvenbach', 'Affiliation': 'Faculty of Medicine, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Herff', 'Affiliation': 'Faculty of Medicine, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}, {'ForeName': 'Wolfgang A', 'Initials': 'WA', 'LastName': 'Wetsch', 'Affiliation': 'Faculty of Medicine, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany. wolfgang.wetsch@uk-koeln.de.'}]",BMC anesthesiology,['10.1186/s12871-021-01502-7']
1368,34813125,HTK-N as a new preservation solution for human kidney preservation: Results of a pilot randomized controlled clinical phase II trial in living donor transplantation.,"BACKGROUND


HTK-N was developed based on the traditional HTK preservation solution, resulting in stronger protection against reactive oxygen species as well as better tolerance to hypothermia and ischemia. Aim of the present study was to compare HTK-N to HTK in clinical kidney transplantation demonstrating safety and non-inferiority.
METHODS


We performed a randomized controlled single blinded clinical phase II trial in patients undergoing living donor kidney transplantation. After retroperitoneoscopic nephrectomy kidneys were either perfused and stored with classical HTK solution or the new HTK-N solution. Primary endpoint was the glomerular filtration rate (eGFR according to CKD EPI) 3 months after transplantation. Secondary endpoints included graft and patient survival beside others.
RESULTS


The study included 42 patients, of which 22 were randomized in the HTK-N group and 20 in the HTK group. The primary end point showed a mean eGFR of 55.4 ± 14.0 ml/min/1.73 m 2  in the HTK group compared to a GFR of 57.2 ± 16.7 ml/min/m 2  in the HTK-N group (P = .72). Regarding secondary endpoints, there were no apparent differences. Posttransplant graft and patient survival was 100%.
CONCLUSION


This study is the first clinical application of HTK-N for kidney preservation and demonstrates non-inferiority compared to HTK in the setting of living donor kidney transplantation.",2022,After retroperitoneoscopic nephrectomy kidneys were either perfused and stored with classical HTK solution or the new HTK-N solution.,"['living donor kidney transplantation', '42 patients, of which 22 were randomized in the HTK-N group and 20 in the HTK group', 'After retroperitoneoscopic nephrectomy kidneys', 'patients undergoing living donor kidney transplantation']","['HTK', 'classical HTK solution or the new HTK-N solution', 'HTK-N to HTK']","['Posttransplant graft and patient survival', 'mean eGFR', 'graft and patient survival beside others', 'glomerular filtration rate (eGFR according to CKD EPI']","[{'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0054039', 'cui_str': 'Bretschneider cardioplegic solution'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C4549550', 'cui_str': 'HTK-N solution'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]",42.0,0.127019,After retroperitoneoscopic nephrectomy kidneys were either perfused and stored with classical HTK solution or the new HTK-N solution.,"[{'ForeName': 'Dieter P', 'Initials': 'DP', 'LastName': 'Hoyer', 'Affiliation': 'General, Visceral, and Transplantation Surgery, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Benkö', 'Affiliation': 'General, Visceral, and Transplantation Surgery, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Gallinat', 'Affiliation': 'General, Visceral, and Transplantation Surgery, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Lefering', 'Affiliation': 'Institute of Research in Operative Medicine, University Witten, Herdecke, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Kaths', 'Affiliation': 'General, Visceral, and Transplantation Surgery, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kribben', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Korth', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Rauen', 'Affiliation': 'Institute of Physiological Chemistry, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Juergen W', 'Initials': 'JW', 'LastName': 'Treckmann', 'Affiliation': 'General, Visceral, and Transplantation Surgery, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'General, Visceral, and Transplantation Surgery, University Hospital Essen, Essen, Germany.'}]",Clinical transplantation,['10.1111/ctr.14543']
1369,34813118,"Corrigendum: Rosli D, Shahar S, Manaf ZA, Lau HJ, Yusof NYM, Haron MR, Majid HA. Randomized controlled trial on the effect of partially hydrolyzed guar gum supplementation on diarrhea frequency and gut microbiome count among pelvic radiation patients. JPEN J Parenter Enteral Nutr. 2021;45(2):277-286.",,2022,,['pelvic radiation patients'],['partially hydrolyzed guar gum supplementation'],['diarrhea frequency and gut microbiome count'],"[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0061996', 'cui_str': 'guar gum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.122445,,[],JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.2295']
1370,34816310,Effects of the association of high fluoride- and calcium-containing caries-preventive agents with regular or high fluoride toothpaste on enamel: an in vitro study.,"OBJECTIVES


The aim of this in vitro study was to compare the caries-preventive effect of various high fluoride- and calcium-containing caries-preventive agents (> 22.000 ppm F -  [ppm]) in adjunct to use of regular (1450 ppm) or high (5000 ppm) fluoride toothpaste on sound as well as demineralized enamel.
MATERIALS AND METHODS


Bovine enamel specimens (n = 276; 5 mm × 3.5 mm × 3 mm) having one sound surface [ST] and one artificial caries lesion [DT] were randomly allocated to 12 groups. Interventions before pH-cycling were no intervention ([SC 1 /SC 5 ]), application of varnishes/solutions containing NaF (22,600 ppm; Duraphat [NaF 1 /NaF 5 ]); NaF + tricalcium phosphate (22,600 ppm; Clinpro White Varnish [TCP 1 /TCP 5 ]); NaF + CPP-ACP (22,600 ppm; MI Varnish [CPP 1 /CPP 5 ]); silver diammine fluoride (35,400 ppm; Cariestop 30%[SDF 1 /SDF 5 ]); and NaF + calcium fluoride (45,200 ppm; Biophat[CaF 1 /CaF 5 ]). During pH-cycling (28 days, 6 × 120 min demineralization/day) half of the specimens in each group were brushed (10 s; 2 × /day) with either 1,450 (NaF; named, e.g., TCP 1 ) or 5,000 ppm (NaF; e.g., TCP 5 ) dentifrice slurry. Differences in integrated mineral loss (∆∆Z) and lesion depth (∆LD) were calculated between values after initial demineralization and after pH-cycling using transversal microradiography.
RESULTS


After pH-cycling, SC 1 /SC 5  showed significantly increased ∆Z DT /LD DT  values, indicating further demineralization (p < 0.05; paired t-test). Decreased ∆Z DT  values, indicating non-significant remineralization, could only be observed in CaF 1 /CaF 5  (p > 0.05; paired t-test). Additional use of all varnishes/solutions significantly decreased ∆∆Z DT /∆∆Z ST  and ∆LD DT /∆LD ST  compared to SC 1 /SC 5  (p < 0.05;ANCOVA). Between 1450 and 5000 ppm dentifrices, a significant difference in ∆∆Z DT /∆∆Z ST  and ∆LD DT /∆LD ST  could only be observed for SC 1 /SC 5  (p < 0.05; ANCOVA).
CONCLUSION


Under the conditions chosen, all fluoride varnishes/solutions significantly reduced demineralization. Furthermore, a significant dose-response characteristic for fluoride varnishes could be revealed. However, no additional benefit could be observed, when varnishes were combined with high fluoride instead of regular fluoride dentifrices.
CLINICAL RELEVANCE


For children and adolescents with high caries risks varnishes containing more than 22,600 ppm should be further investigated, as they offered higher caries-preventive effects in vitro. Furthermore, there seems to be no difference in the demineralization-inhibitory capacity of fluoride varnishes when used in combination with either standard or highly fluoridated dentifrices.",2022,Additional use of all varnishes/solutions significantly decreased ∆∆Z DT /∆∆Z ST  and ∆LD DT /∆LD,"['For children and adolescents with high caries risks varnishes containing more than 22,600\xa0ppm', 'Bovine enamel specimens (n\u2009=\u2009276']","['NaF\u2009+\u2009calcium fluoride', '∆Z', '5\xa0mm\u2009×\u20093.5\xa0mm\u2009×\u20093\xa0mm) having one sound surface [ST] and one artificial caries lesion [DT', 'varnishes/solutions containing NaF (22,600\xa0ppm; Duraphat [NaF 1 /NaF 5 ]); NaF\u2009+\u2009tricalcium phosphate (22,600\xa0ppm; Clinpro White Varnish [TCP 1 /TCP 5 ]); NaF\u2009+\u2009CPP-ACP (22,600\xa0ppm; MI Varnish [CPP 1 /CPP 5 ]); silver diammine fluoride', 'regular (1450\xa0ppm) or high (5000\xa0ppm) fluoride toothpaste', 'TCP 1 ) or 5,000\xa0ppm (NaF; e.g., TCP 5 ) dentifrice slurry', 'DT /LD', 'fluoride toothpaste', 'various high fluoride- and calcium-containing caries-preventive agents (>\u200922.000\xa0ppm F -  [ppm']","['∆Z', 'demineralization', '∆∆Z DT /∆∆Z ST  and ∆LD DT /∆LD', 'integrated mineral loss (∆∆Z) and lesion depth (∆LD', 'enamel']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0006695', 'cui_str': 'Calcium Fluoride'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0058817', 'cui_str': 'Duraphat'}, {'cui': 'C0108136', 'cui_str': 'tricalcium phosphate'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0044091', 'cui_str': '1-(1-(2-thienyl) cyclohexyl) piperidine'}, {'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}, {'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0700185', 'cui_str': 'Decalcified structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}]",,0.0333918,Additional use of all varnishes/solutions significantly decreased ∆∆Z DT /∆∆Z ST  and ∆LD DT /∆LD,"[{'ForeName': 'Richard Johannes', 'Initials': 'RJ', 'LastName': 'Wierichs', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, zmk bern, University of Bern, Freiburgstrasse 7, CH-3010, Bern, Switzerland. Richard.wierichs@zmk.unibe.ch.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Mester', 'Affiliation': 'Department of CariologyEndodontology and Periodontology, University of Leipzig, Liebigstraße 12, 04103, Leipzig, Germany.'}, {'ForeName': 'Thomas Gerhard', 'Initials': 'TG', 'LastName': 'Wolf', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, zmk bern, University of Bern, Freiburgstrasse 7, CH-3010, Bern, Switzerland.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Meyer-Lueckel', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, zmk bern, University of Bern, Freiburgstrasse 7, CH-3010, Bern, Switzerland.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Esteves-Oliveira', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, zmk bern, University of Bern, Freiburgstrasse 7, CH-3010, Bern, Switzerland.'}]",Clinical oral investigations,['10.1007/s00784-021-04299-4']
1371,34618594,Monetary incentives increase COVID-19 vaccinations.,"The stalling of COVID-19 vaccination rates threatens public health. To increase vaccination rates, governments across the world are considering the use of monetary incentives. Here we present evidence about the effect of guaranteed payments on COVID-19 vaccination uptake. We ran a large preregistered randomized controlled trial (with 8286 participants) in Sweden and linked the data to population-wide administrative vaccination records. We found that modest monetary payments of 24 US dollars (200 Swedish kronor) increased vaccination rates by 4.2 percentage points ( P  = 0.005), from a baseline rate of 71.6%. By contrast, behavioral nudges increased stated intentions to become vaccinated but had only small and not statistically significant impacts on vaccination rates. The results highlight the potential of modest monetary incentives to raise vaccination rates.",2021,[Figure: see text].,[],[],[],[],[],[],,0.0727732,[Figure: see text].,"[{'ForeName': 'Pol', 'Initials': 'P', 'LastName': 'Campos-Mercade', 'Affiliation': 'Department of Economics, Center for Economic Behavior and Inequality (CEBI), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Armando N', 'Initials': 'AN', 'LastName': 'Meier', 'Affiliation': 'Unisanté, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Florian H', 'Initials': 'FH', 'LastName': 'Schneider', 'Affiliation': 'Department of Economics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Meier', 'Affiliation': 'Columbia Business School, Columbia University, New York, NY, USA.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Pope', 'Affiliation': 'Booth School of Business, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Wengström', 'Affiliation': 'Department of Economics, Lund University, Lund, Sweden.'}]","Science (New York, N.Y.)",['10.1126/science.abm0475']
1372,34818966,Polyurethane foam dressings ameliorating local adverse effects of azacitidine: a randomized controlled trial.,"This study investigated the use of polyurethane foam dressings to prevent local adverse reactions of subcutaneous azacitidine injection. Patients receiving a subcutaneous azacitidine injection were randomly divided into experimental and control groups. A total of 55 patients were included in each group. A polyurethane foam dressing was used to cover the injection site of patients in the experimental group. Conventional treatment was used in the control group. Injection site pain and local skin reactions were assessed after the intervention in both groups. The score and duration of pain, the incidence and duration of local skin adverse reactions, and the incidence of severe reactions in the experimental group were significantly lower than in the control group ( p  < 0.05). Polyurethane foam dressing can effectively reduce local adverse reactions of subcutaneous injection of azacitidine, relieve pain, shorten the duration of local pain and adverse reactions, and improve the quality of nursing.",2022,"The score and duration of pain, the incidence and duration of local skin adverse reactions, and the incidence of severe reactions in the experimental group were significantly lower than in the control group ( p  < 0.05).","['Patients receiving a subcutaneous azacitidine injection', 'A total of 55 patients were included in each group']","['azacitidine', 'polyurethane foam dressings', 'subcutaneous azacitidine injection', 'Polyurethane foam dressings']","['score and duration of pain, the incidence and duration of local skin adverse reactions, and the incidence of severe reactions', 'Injection site pain and local skin reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4049756', 'cui_str': 'Azacitidine Injection'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0460852', 'cui_str': 'Polyurethane foam dressing'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4049756', 'cui_str': 'Azacitidine Injection'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}]",55.0,0.0592393,"The score and duration of pain, the incidence and duration of local skin adverse reactions, and the incidence of severe reactions in the experimental group were significantly lower than in the control group ( p  < 0.05).","[{'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Fujian Institute of Hematology, Fujian Provincial Key Laboratory on Hematology, Fujian Medical University Union Hospital, Fuzhou City, China.'}, {'ForeName': 'Chunrong', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Fujian Institute of Hematology, Fujian Provincial Key Laboratory on Hematology, Fujian Medical University Union Hospital, Fuzhou City, China.'}, {'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Fujian Institute of Hematology, Fujian Provincial Key Laboratory on Hematology, Fujian Medical University Union Hospital, Fuzhou City, China.'}, {'ForeName': 'Meihua', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Fujian Institute of Hematology, Fujian Provincial Key Laboratory on Hematology, Fujian Medical University Union Hospital, Fuzhou City, China.'}, {'ForeName': 'Jinxiang', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Fujian Institute of Hematology, Fujian Provincial Key Laboratory on Hematology, Fujian Medical University Union Hospital, Fuzhou City, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Fujian Institute of Hematology, Fujian Provincial Key Laboratory on Hematology, Fujian Medical University Union Hospital, Fuzhou City, China.'}, {'ForeName': 'Saizhen', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Fujian Institute of Hematology, Fujian Provincial Key Laboratory on Hematology, Fujian Medical University Union Hospital, Fuzhou City, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Fujian Institute of Hematology, Fujian Provincial Key Laboratory on Hematology, Fujian Medical University Union Hospital, Fuzhou City, China.'}, {'ForeName': 'Yanjuan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Fujian Medical University Union Hospital, Fuzhou City, China.'}]",Leukemia & lymphoma,['10.1080/10428194.2021.1998482']
1373,34819721,"The Efficacy and Safety of Remimazolam Tosilate versus Etomidate-Propofol in Elderly Outpatients Undergoing Colonoscopy: A Prospective, Randomized, Single-Blind, Non-Inferiority Trial.","Objective


The optimal sedation regime during endoscopy remains controversial, especially for elderly outpatients. In this study, we compared the efficacy and safety between remimazolam tosilate (RT) and etomidate-propofol (EP) in elderly outpatients undergoing colonoscopy.
Methods


A total of 260 elderly outpatients undergoing sedative colonoscopy were randomized into two groups. Patients in the RT group received a 0.075-mg/kg maintenance dose of remimazolam following an initial dose of 0.15 mg/kg, whereas patients in the EP group (10 mL:20 mg etomidate plus 10 mL:100 mg propofol) received a 0.05-mL/kg maintenance dose following an initial dose of 0.1 mL/kg to maintain a Modified Observer's Assessment of Alertness/Sedation score of ≤3 during the procedure. The primary endpoint was the success of the procedure. Secondary endpoints included time metrics, hemodynamics, consumption of fentanyl, etomidate, propofol, and remimazolam, intraoperative body movement, patient and endoscopist satisfaction scores, supplemental dose of sedative and fentanyl, and incidence and severity of adverse events.
Results


The procedure success rate was 96.52% in the RT group and 100% in the EP group. The difference in procedure success rate between the RT and EP groups was -3.48% (95% confidence interval: -6.81%, -0.15%). Four patients in the RT group required rescue midazolam. Compared with patients in the RT group, the onset time of the EP group was significantly lower ( p  < 0.05), whereas time to fully alert ( p  = 0.001), ready for discharge ( p  = 0.001), and hospital discharge ( p  = 0.002) were all significantly higher in the EP group. However, there were no significant differences in procedure time ( p  = 0.846) or cecal intubation time ( p  = 0.320) between the two groups. Although the frequency of intraoperative body movement was higher in the RT group, the difference was not significant ( p  = 0.508). There were no significant differences in patients' demographic and baseline characteristics, supplemental doses of sedative and fentanyl, or patient and endoscopist satisfaction scores ( p  > 0.05). Muscular tremor and pain on injection were recorded more frequently in the EP group ( p  < 0.05). However, there were no significant differences in hypoxia, respiratory depression, or incidence of postoperative nausea and vomiting. The severity of adverse events was all mild (grade 1) across both groups.
Conclusion


RT may have non-inferior efficacy and a higher safety profile than EP in elderly outpatients undergoing colonoscopy, which suggests that RT may be more suitable for elderly outpatients undergoing colonoscopy.",2021,"However, there were no significant differences in procedure time ( p  = 0.846) or cecal intubation time ( p  = 0.320) between the two groups.","['elderly outpatients', 'elderly outpatients undergoing', 'Elderly Outpatients', '260 elderly outpatients undergoing sedative colonoscopy', 'elderly outpatients undergoing colonoscopy']","['etomidate plus 10 mL:100 mg propofol', 'remimazolam tosilate (RT) and etomidate-propofol (EP', 'Undergoing Colonoscopy', 'Remimazolam Tosilate versus Etomidate-Propofol', 'midazolam', 'colonoscopy', 'remimazolam']","['hospital discharge', 'ready for discharge', 'Muscular tremor and pain on injection', 'severity of adverse events', 'hypoxia, respiratory depression, or incidence of postoperative nausea and vomiting', 'procedure time', 'onset time', 'time metrics, hemodynamics, consumption of fentanyl, etomidate, propofol, and remimazolam, intraoperative body movement, patient and endoscopist satisfaction scores, supplemental dose of sedative and fentanyl, and incidence and severity of adverse events', 'procedure success rate', 'efficacy and safety', ""patients' demographic and baseline characteristics, supplemental doses of sedative and fentanyl, or patient and endoscopist satisfaction scores"", 'cecal intubation time', 'frequency of intraoperative body movement', 'time to fully alert', 'success of the procedure']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C2314972', 'cui_str': 'Ready for discharge'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",260.0,0.0647742,"However, there were no significant differences in procedure time ( p  = 0.846) or cecal intubation time ( p  = 0.320) between the two groups.","[{'ForeName': 'Xianwen', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Anaesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, People's Republic of China.""}, {'ForeName': 'Baofeng', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': ""Department of Anaesthesiology, Liaocheng Second People's Hospital, Liaocheng, Shandong, People's Republic of China.""}, {'ForeName': 'Fu', 'Initials': 'F', 'LastName': 'Shi', 'Affiliation': ""Department of Anaesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Anaesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Anaesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, People's Republic of China.""}, {'ForeName': 'Yongwei', 'Initials': 'Y', 'LastName': 'Sha', 'Affiliation': ""Department of Anaesthesiology, Guanxian Central Hospital, Liaocheng, Shandong, People's Republic of China.""}, {'ForeName': 'Tonghang', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': ""Department of Anaesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S339535']
1374,34821978,Effects of different remineralization agents on MIH defects: a randomized clinical study.,"OBJECTIVES


The aim of this study was to present a comparative evaluation of the long-term efficacy of fluoride varnish and pastes containing CPP-ACP and CPP-ACP with fluoride (CPP-ACFP) in the remineralization of creamy-white and yellow-brown defects in permanent first molars with MIH.
MATERIALS AND METHODS


The study included 120 teeth with yellow-brown or creamy-white defects in 67 children (37 girls, 30 boys) aged 6-9 years (mean, 7.2) who were newly diagnosed with MIH with no substance loss or caries or prior restorative treatment. The patients were randomly divided into the experiment groups; control (oral hygiene motivation only), fluoride varnish, and pastes containing CPP-ACP and CPP-ACPF, and followed up for 24 months. The evaluations were made based on the ICDAS criteria and the measurements which were performed using the laser fluorescence method (DIAGNOdent, KaVo, Biberach, Germany) in the follow-ups.
RESULTS


The research was completed with 49 patients (23 females, 26 males; mean age, 7.7) and 90 teeth. All remineralization agents increased remineralization rates in both creamy-white and yellow-brown colored defects without presenting any statistically significant difference at the end of the follow-up period (p > 0.05). However, the effects of fluoride varnishes were late to observe when compared to pastes containing CPP-ACP and CPP-ACPF.
CONCLUSIONS


Pastes containing calcium and phosphate may be recommended for the longer-term preservation of teeth with yellow-brown defects which showed a post-eruptive breakdown in a shorter time.
CLINICAL RELEVANCE


There is a lack of studies investigating MIH treatments in which lesion appearance was recorded. This study evaluated creamy-white and yellow-brown MIH defects separately and reported long-term results of different remineralization agents.",2022,All remineralization agents increased remineralization rates in both creamy-white and yellow-brown colored defects without presenting any statistically significant difference at the end of the follow-up period (p > 0.05).,"['120 teeth with yellow-brown or creamy-white defects in 67 children (37 girls, 30 boys) aged 6-9 years (mean, 7.2) who were newly diagnosed with MIH with no substance loss or caries or prior restorative treatment', '49 patients (23 females, 26 males; mean age, 7.7) and 90 teeth', 'creamy-white and yellow-brown defects in permanent first molars with MIH']","['remineralization agents', 'control (oral hygiene motivation only), fluoride varnish, and pastes containing CPP-ACP and CPP-ACPF', 'fluoride varnishes', 'fluoride varnish and pastes containing CPP-ACP and CPP-ACP with fluoride (CPP-ACFP']","['MIH defects', 'remineralization rates']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0221205', 'cui_str': 'Yellow color'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442751', 'cui_str': 'Distance vision 6/9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}]","[{'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}]","[{'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0243067', 'cui_str': 'defects'}]",120.0,0.0325859,All remineralization agents increased remineralization rates in both creamy-white and yellow-brown colored defects without presenting any statistically significant difference at the end of the follow-up period (p > 0.05).,"[{'ForeName': 'Irem Can', 'Initials': 'IC', 'LastName': 'Olgen', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Hayriye', 'Initials': 'H', 'LastName': 'Sonmez', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Bezgin', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Ankara University, Ankara, Turkey. cetintugba@yahoo.com.'}]",Clinical oral investigations,['10.1007/s00784-021-04305-9']
1375,34823469,"Comparison of the effects of open vs. closed skill exercise on the acute and chronic BDNF, IGF-1 and IL-6 response in older healthy adults.","BACKGROUND


Accumulating evidence shows that physical exercise has a positive effect on the release of neurotrophic factors and myokines. However, evidence regarding the optimal type of physical exercise for these release is still lacking. The aim of this study was to assess the acute and chronic effects of open-skill exercise (OSE) compared to closed-skill exercise (CSE) on serum and plasma levels of brain derived neurotrophic factor (BDNF S , BDNF P ), and serum levels of insulin like growth factor 1 (IGF-1), and interleukin 6 (IL-6) in healthy older adults.
METHODS


To investigate acute effects, thirty-eight participants were randomly assigned to either an intervention (badminton (aOSE) and bicycling (aCSE), n  = 24, 65.83 ± 5.98 years) or control group (reading (CG), n  = 14, 67.07 ± 2.37 years). Blood samples were taken immediately before and 5 min after each condition. During each condition, heart rate was monitored. The mean heart rate of aOSE and aCSE were equivalent (65 ± 5% of heart rate reserve). In a subsequent 12-week training-intervention, twenty-two participants were randomly assigned to either a sport-games (cOSE, n  = 6, 64.50 ± 6.32) or a strength-endurance training (cCSE, n  = 9, 64.89 ± 3.51) group to assess for chronic effects. Training intensity for both groups was adjusted to a subjective perceived exertion using the CR-10 scale (value 7). Blood samples were taken within one day after the training-intervention.
RESULTS


BDNF S , BDNF P , IGF-1, and IL-6 levels increased after a single exercise session of 30 min. After 12 weeks of training BDNF S  and IL-6 levels were elevated, whereas IGF-1 levels were reduced in both groups. However, only in the cOSE group these changes were significant. We could not find any significant differences between the exercise types.
CONCLUSION


Our results indicate that both exercise types are efficient to acutely increase BDNF S , BDNF P , IGF-1 and IL-6 serum levels in healthy older adults. Additionally, our results tend to support that OSE is more effective for improving basal BDNF S  levels after 12 weeks of training.",2021,"After 12 weeks of training BDNF S  and IL-6 levels were elevated, whereas IGF-1 levels were reduced in both groups.","['older healthy adults', 'healthy older adults', 'thirty-eight participants']","['OSE', 'intervention (badminton (aOSE) and bicycling (aCSE), n\u2009 =\u200924, 65.83\u2009±\u20095.98\xa0years) or control group (reading (CG', 'physical exercise', 'open-skill exercise (OSE', 'closed-skill exercise (CSE', 'open vs. closed skill exercise', 'sport-games (cOSE, n \u2009=\u20096, 64.50\u2009±\u20096.32) or a strength-endurance training (cCSE']","['basal BDNF S  levels', 'serum and plasma levels of brain derived neurotrophic factor (BDNF S , BDNF P ), and serum levels of insulin like growth factor 1 (IGF-1), and interleukin 6 (IL-6', 'BDNF S , BDNF P , IGF-1 and IL-6 serum levels', 'heart rate', 'mean heart rate of aOSE and aCSE', 'BDNF S , BDNF P , IGF-1, and IL-6 levels', 'IL-6 levels', 'acute and chronic BDNF, IGF-1 and IL-6 response', 'IGF-1 levels']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450361', 'cui_str': '38'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004678', 'cui_str': 'Badminton'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]",22.0,0.00661664,"After 12 weeks of training BDNF S  and IL-6 levels were elevated, whereas IGF-1 levels were reduced in both groups.","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Behrendt', 'Affiliation': 'Chair for Health and Physical Activity, Department of Sport Science, Faculty of Humanities, Otto-von-Guericke University Magdeburg, Magdeburg, Germany. tom.behrendt@ovgu.de.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Kirschnick', 'Affiliation': 'Department of Internal Medicine, Division of Cardiology and Angiology, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Kröger', 'Affiliation': 'Chair for Health and Physical Activity, Department of Sport Science, Faculty of Humanities, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Beileke', 'Affiliation': 'Chair for Health and Physical Activity, Department of Sport Science, Faculty of Humanities, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Rezepin', 'Affiliation': 'Chair for Health and Physical Activity, Department of Sport Science, Faculty of Humanities, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Brigadski', 'Affiliation': 'Department of Informatics and Microsystem Technology, University of Applied Sciences, Kaiserslautern, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Leßmann', 'Affiliation': 'Institute of Physiology, Medical Faculty, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Schega', 'Affiliation': 'Chair for Health and Physical Activity, Department of Sport Science, Faculty of Humanities, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.'}]",BMC neuroscience,['10.1186/s12868-021-00675-8']
1376,34826116,Triptorelin stimulated luteinizing hormone concentrations for diagnosing central precocious puberty: study of diagnostic accuracy.,"PURPOSE


Gonadotropin-releasing hormone (GnRH) stimulation test is the gold standard for diagnosing central precocious puberty (CPP). However, intravenous GnRH is not always readily available. The aim of the present study was to evaluate the diagnostic accuracy of triptorelin-stimulated luteinizing hormone (LH) concentrations in the diagnosis of CPP among girls presenting with premature thelarche compared to the gold standard GnRH test.
METHODS


A prospective, case-control (CPP vs isolated premature thelarche), clinical study evaluating the diagnostic accuracy of triptorelin-stimulated LH concentrations in 60 girls with premature thelarche was performed. All girls underwent stimulation with subcutaneous triptorelin injection and intravenous GnRH in a randomized order. During the stimulation test with triptorelin, LH and FSH were measured at time 0, 30, 60, 90, 120, and 180 min after the injection. Estradiol was sampled 24 h after the injection. During the GnRH test, LH and FSH were measured at time 0, 30, 45, and 60 min. Girls with peak GnRH-stimulated LH concentrations ≥5.0 IU/L were classified as having CPP. Area under the curve (AUC) for triptorelin-stimulated LH concentrations was assessed using the receiver operating characteristic (ROC) analysis.
RESULTS


Triptorelin-stimulated LH concentrations were significantly higher in girls who had CPP according to the GnRH test (53.3%). LH peaked at 180 min after the triptorelin injection. The highest diagnostic accuracy for CPP (AUC = 0.973, sensitivity 96.9%, specificity 89.3%) at 180 min was at a LH concentration ≥3.4 IU/L. The 24 h estradiol concentration did not improve the predictive model.
CONCLUSIONS


Measuring LH concentrations 180 min after triptorelin injection with a cut-off value of ≥3.4 IU/L demonstrated a high diagnostic accuracy compared to the GnRH test. Thus, stimulation with triptorelin can be used as a reliable alternative for diagnosing CPP in girls with premature thelarche.",2022,"The highest diagnostic accuracy for CPP (AUC = 0.973, sensitivity 96.9%, specificity 89.3%) at 180 min was at a LH concentration ≥3.4 IU/","['diagnosing central precocious puberty (CPP', 'Girls with peak GnRH-stimulated LH concentrations', 'girls with premature thelarche', 'girls presenting with premature thelarche', 'diagnosing central precocious puberty', '60 girls with premature thelarche']","['control (CPP vs isolated premature thelarche', 'Gonadotropin-releasing hormone (GnRH) stimulation test', 'triptorelin, LH and FSH', 'triptorelin', 'Triptorelin', 'triptorelin-stimulated luteinizing hormone (LH', 'triptorelin-stimulated LH concentrations', 'Estradiol', 'subcutaneous triptorelin injection and intravenous GnRH', 'intravenous GnRH']","['Area under the curve (AUC) for triptorelin-stimulated LH concentrations', 'LH', 'LH concentrations', 'highest diagnostic accuracy', 'luteinizing hormone concentrations', 'diagnostic accuracy', 'LH and FSH']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0342543', 'cui_str': 'Central precocious puberty'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0425772', 'cui_str': 'Premature development of the breasts'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0342543', 'cui_str': 'Central precocious puberty'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0425772', 'cui_str': 'Premature development of the breasts'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0201780', 'cui_str': 'Stimulation test'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4301188', 'cui_str': 'Triptorelin Injection'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}]",60.0,0.158713,"The highest diagnostic accuracy for CPP (AUC = 0.973, sensitivity 96.9%, specificity 89.3%) at 180 min was at a LH concentration ≥3.4 IU/","[{'ForeName': 'Rade', 'Initials': 'R', 'LastName': 'Vukovic', 'Affiliation': 'Department of Endocrinology, Mother and Child Health Care Institute of Serbia ""Dr Vukan Cupic"", Radoja Dakica 8, 11070, Belgrade, Serbia. radevukovic9@gmail.com.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Milenkovic', 'Affiliation': 'Department of Endocrinology, Mother and Child Health Care Institute of Serbia ""Dr Vukan Cupic"", Radoja Dakica 8, 11070, Belgrade, Serbia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Soldatovic', 'Affiliation': 'School of Medicine, University of Belgrade, Dr Subotica 8, 11 000, Belgrade, Serbia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Pekic', 'Affiliation': 'School of Medicine, University of Belgrade, Dr Subotica 8, 11 000, Belgrade, Serbia.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Mitrovic', 'Affiliation': 'Department of Endocrinology, Mother and Child Health Care Institute of Serbia ""Dr Vukan Cupic"", Radoja Dakica 8, 11070, Belgrade, Serbia.'}, {'ForeName': 'Sladjana', 'Initials': 'S', 'LastName': 'Todorovic', 'Affiliation': 'Department of Endocrinology, Mother and Child Health Care Institute of Serbia ""Dr Vukan Cupic"", Radoja Dakica 8, 11070, Belgrade, Serbia.'}]",Endocrine,['10.1007/s12020-021-02947-z']
1377,34838432,Efficacy of Withania somnifera supplementation on adult's cognition and mood.,"The present study examined the effects of a proprietary Ashwagandha (Withania somnifera) root and leaf extract (NooGandha® Specnova LLC, USA) supplement for improving cognitive abilities, cortisol levels, and self-reported mood, stress, food cravings, and anxiety with adults who have perceived stress. Healthy adults (n = 43 women and n = 17 men; mean age = 34.41 years) who reported experiencing perceived stress were randomized to the following groups: Ashwagandha (400 mg/d), Ashwagandha (225 mg/d), and placebo for 30 days. The following outcomes were assessed at Day 0, Day 15, and Day 30: saliva cortisol levels, cognitive performance (i.e., CNS vital signs), and the self-reported measures of Trait Anxiety Inventory, Depression Anxiety Stress Scale, Perceived Stress Scale, and Food Cravings Questionnaire-15. For the self-report assessments, significant main effects for time were evidenced for anxiety, depression, perceived stress, and food cravings, p's < 0.01. The main effect for group and the interactions were non-significant. For the CNS vital signs, significant differences were observed in cognitive flexibility, visual memory, reaction time, psychomotor speed, and executive functioning, p's < 0.05, with the Ashwagandha groups often out-performing the placebo group. Both Ashwagandha groups had reductions in cortisol levels over time, with significant reductions evidenced for the Ashwagandha 225 mg/d group from Day 0 to Day 15 to Day 30. The placebo group had a non-significant increase in cortisol levels from Day 0 to Day 15-30. No adverse events were reported. In conclusion, Ashwagandha supplementation may improve the physiological, cognitive, and psychological effects of stress.",2021,"For the CNS vital signs, significant differences were observed in cognitive flexibility, visual memory, reaction time, psychomotor speed, and executive functioning,","['with adults who have perceived stress', ""adult's cognition and mood"", 'Healthy adults (n\xa0=\xa043 women and', 'n\xa0=\xa017 men; mean age\xa0=\xa034.41 years) who reported experiencing perceived stress']","['placebo', 'Withania somnifera supplementation', 'proprietary Ashwagandha (Withania somnifera) root and leaf extract (NooGandha® Specnova LLC, USA) supplement']","['anxiety, depression, perceived stress, and food cravings', 'saliva cortisol levels, cognitive performance (i.e., CNS vital signs), and the self-reported measures of Trait Anxiety Inventory, Depression Anxiety Stress Scale, Perceived Stress Scale, and Food Cravings Questionnaire-15', 'adverse events', 'cognitive flexibility, visual memory, reaction time, psychomotor speed, and executive functioning', 'cortisol levels', 'physiological, cognitive, and psychological effects of stress', 'cognitive abilities, cortisol levels, and self-reported mood, stress, food cravings, and anxiety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1061163', 'cui_str': 'Withania somnifera'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",43.0,0.107718,"For the CNS vital signs, significant differences were observed in cognitive flexibility, visual memory, reaction time, psychomotor speed, and executive functioning,","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Remenapp', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Coyle', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Orange', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lynch', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hooper', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hooper', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Conway', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, USA.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Hausenblas', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, USA. Electronic address: hhausen@ju.edu.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2021.08.003']
1378,34840276,Moderate effect of ankle foot orthosis versus ground reaction ankle foot orthosis on balance in children with diplegic cerebral palsy.,"BACKGROUND


The children with diplegic cerebral palsy (CP) commonly have abnormal alignment of lower extremities affecting their abilities of keeping balance. Orthoses are one of the many approaches that can be prescribed to improve balance and walking in diplegic children.
OBJECTIVE


This study was conducted to assess the moderate effect of solid ankle foot orthosis (AFO) vs. the ground reaction ankle foot orthosis (GRAFO) on balance in children with diplegic CP.
STUDY DESIGN


A randomized controlled trial.
METHODS


Thirty children with spastic diplegic CP from both genders participated in this study; their ages were between 6 and 9 years. They were divided randomly into two study groups of equal numbers; the first study group A received the regular physical therapy program besides wearing the AFO for successive three months. The second study group B received the regular physical therapy program besides wearing the GRAFO for successive 3 months. All childrens' balance was evaluated before starting the treatment program and after 3 months by using the Biodex balance system (anteroposterior and mediolateral stability indices).
RESULTS


There were significant improvement of all stability indices in both groups (P < 0.05), with significant difference between groups when comparing post-treatment mean values of the measured indices in favor to study group B (P < 0.05).
CONCLUSION


The GRAFO achieved more balance control in children with spastic diplegic CP compared with solid AFO.",2022,"There were significant improvement of all stability indices in both groups (P < 0.05), with significant difference between groups when comparing post-treatment mean values of the measured indices in favor to study group B (P < 0.05).
","['Thirty children with spastic diplegic CP from both genders participated in this study; their ages were between 6 and 9 years', 'children with diplegic cerebral palsy (CP', 'children with diplegic cerebral palsy', 'children with diplegic CP']","['GRAFO', 'solid AFO', 'regular physical therapy program besides wearing the AFO', 'solid ankle foot orthosis (AFO) vs. the ground reaction ankle foot orthosis (GRAFO', 'regular physical therapy program besides wearing the GRAFO', 'ankle foot orthosis versus ground reaction ankle foot orthosis']",['stability indices'],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270804', 'cui_str': 'Diplegic cerebral palsy'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1283250', 'cui_str': 'Foot orthosis'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",30.0,0.0220019,"There were significant improvement of all stability indices in both groups (P < 0.05), with significant difference between groups when comparing post-treatment mean values of the measured indices in favor to study group B (P < 0.05).
","[{'ForeName': 'Doaa Ahmed', 'Initials': 'DA', 'LastName': 'Sanad', 'Affiliation': 'Pediatric Physical Therapy Department, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Prosthetics and orthotics international,['10.1097/PXR.0000000000000060']
1379,34841633,Repetitive transcranial magnetic stimulation modulates coupling among large-scale brain networks in heroin-dependent individuals: A randomized resting-state functional magnetic resonance imaging study.,"The abnormal interactions of three key large-scale brain networks (default mode [DMN], salience and executive control [ECN]) were showed underlie dysfunctions in heroin addiction. Repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (DLPFC) is a potential treatment for heroin addiction. It is unclear whether impaired coupling among the large-scale brain networks would be improved by rTMS in treated heroin-dependent individuals. Thirty-five heroin-dependent individuals were included in this sham-controlled, randomized study. The patients received either active or sham rTMS for 1 week. The craving for heroin and resting-state functional magnetic resonance imaging data were collected before and after 1-week rTMS. Twenty-two healthy subjects were included as controls not receiving rTMS. After 1-week rTMS, only the active rTMS group showed a significant decrease in spontaneous and heroin cue-induced craving. The coupling between left DLPFC (a key node of left ECN) and left parahippocampal gyrus (PHG, included in DMN) significantly increased for the active group with a tendency towards that of controls. The coupling between the right precentral gyrus and three key regions included in DMN (posterior cingulate cortex/precuneus and bilateral inferior parietal cortex) significantly decreased for the active group with a tendency towards that of healthy controls. For the active rTMS individuals, the left DLPFC-PHG coupling negatively correlated with the spontaneous craving and the drug cue-induced craving. It suggested that the rTMS could reduce heroin craving, which might be related to the modulation of ECN-DMN coupling. This finding might shed light on the mechanism of rTMS for heroin addiction treatment.",2022,It is unclear whether impaired coupling among the large-scale brain networks would be improved by rTMS in treated heroin-dependent individuals.,"['Thirty-five heroin-dependent individuals', 'heroin addiction', 'Twenty-two healthy subjects were included as controls not receiving rTMS', 'heroin-dependent individuals']","['Repetitive transcranial magnetic stimulation', 'Repetitive transcranial magnetic stimulation (rTMS', 'active or sham rTMS', 'rTMS']","['heroin craving', 'spontaneous and heroin cue-induced craving', 'DMN (posterior cingulate cortex/precuneus and bilateral inferior parietal cortex']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019337', 'cui_str': 'Heroin dependence'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0012431', 'cui_str': 'N-nitrosodimethylamine'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}]",22.0,0.00964071,It is unclear whether impaired coupling among the large-scale brain networks would be improved by rTMS in treated heroin-dependent individuals.,"[{'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': ""Department of Nuclear Medicine, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Menghui', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': ""Department of Nuclear Medicine, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Nuclear Medicine, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ""Department of Radiology, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ""Department of Nuclear Medicine, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Nuclear Medicine, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Qianrong', 'Initials': 'Q', 'LastName': 'Bai', 'Affiliation': ""Department of Nuclear Medicine, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Nuclear Medicine, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Longxiao', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ""Department of Nuclear Medicine, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}]",Addiction biology,['10.1111/adb.13121']
1380,34843662,"Prevention of SARS-CoV-2 transmission during a large, live, indoor gathering (SPRING): a non-inferiority, randomised, controlled trial.","BACKGROUND


Mass indoor gatherings were banned in early 2020 to prevent the spread of SARS-CoV-2. We aimed to assess, under controlled conditions, whether infection rates among attendees at a large, indoor gathering event would be similar to those in non-attendees, given implementation of a comprehensive prevention strategy including antigen-screening within 3 days, medical mask wearing, and optimised ventilation.
METHODS


The non-inferiority, prospective, open-label, randomised, controlled SPRING trial was done on attendees at a live indoor concert held in the Accor Arena on May 29, 2021 in Paris, France. Participants, aged 18-45 years, recruited via a dedicated website, had no comorbidities, COVID-19 symptoms, or recent case contact, and had had a negative rapid antigen diagnostic test within 3 days before the concert. Participants were randomly allocated in a 2:1 ratio to the experimental group (attendees) or to the control group (non-attendees). The allocation sequence was computer-generated by means of permuted blocks of sizes three, six, or nine, with no stratification. The primary outcome measure was the number of patients who were SARS-CoV-2-positive by RT-PCR test on self-collected saliva 7 days post-gathering in the per-protocol population (non-inferiority margin <0·35%). This trial is registered with ClinicalTrials.gov, NCT04872075.
FINDINGS


Between May 11 and 25, 2021, 18 845 individuals registered on the dedicated website, and 10 953 were randomly selected for a pre-enrolment on-site visit. Among 6968 who kept the appointment and were screened, 6678 participants were randomly assigned (4451 were assigned to be attendees and 2227 to be non-attendees; median age 28 years; 59% women); 88% (3917) of attendees and 87% (1947) of non-attendees complied with follow-up requirements. The day 7 RT-PCR was positive for eight of the 3917 attendees (observed incidence, 0·20%; 95% CI 0·09-0·40) and three of the 1947 non-attendees (0·15%; 0·03-0·45; absolute difference, 95% CI -0·26% to 0·28%), findings that met the non-inferiority criterion for the primary endpoint.
INTERPRETATION


Participation in a large, indoor, live gathering without physical distancing was not associated with increased SARS-CoV-2-transmission risk, provided a comprehensive preventive intervention was implemented.
FUNDING


French Ministry of Health.
TRANSLATION


For the French translation of the abstract see Supplementary Materials section.",2022,"The day 7 RT-PCR was positive for eight of the 3917 attendees (observed incidence, 0·20%; 95% CI 0·09-0·40) and three of the 1947 non-attendees (0·15%; 0·03-0·45; absolute difference, 95% CI -0·26% to 0·28%), findings that met the non-inferiority criterion for the primary endpoint.
","[' 18\u2009845 individuals registered on the dedicated website, and 10\u2009953 were randomly selected for a pre-enrolment on-site visit', 'Between May 11 and 25, 2021', '6968 who kept the appointment and were screened, 6678 participants were randomly assigned (4451 were assigned to be attendees and 2227 to be non-attendees; median age 28 years; 59% women); 88% (3917) of attendees and 87% (1947) of non-attendees complied with follow-up requirements', 'attendees at a live indoor concert held in the Accor Arena on May 29, 2021 in Paris, France', 'Participants, aged 18-45 years, recruited via a dedicated website, had no comorbidities, COVID-19 symptoms, or recent case contact, and had had a negative rapid antigen diagnostic test within 3 days before the concert']","['comprehensive prevention strategy including antigen-screening within 3 days, medical mask wearing, and optimised ventilation']",['number of patients who were SARS-CoV-2-positive by RT-PCR test on self-collected saliva 7 days post-gathering'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1998203', 'cui_str': 'Person exposed to disease'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",6678.0,0.460532,"The day 7 RT-PCR was positive for eight of the 3917 attendees (observed incidence, 0·20%; 95% CI 0·09-0·40) and three of the 1947 non-attendees (0·15%; 0·03-0·45; absolute difference, 95% CI -0·26% to 0·28%), findings that met the non-inferiority criterion for the primary endpoint.
","[{'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Delaugerre', 'Affiliation': 'Service de Virologie, AP-HP, Hôpital Saint Louis, Paris, France; Université de Paris, INSERM, U944, Paris, France. Electronic address: constance.delaugerre@aphp.fr.'}, {'ForeName': 'Frantz', 'Initials': 'F', 'LastName': 'Foissac', 'Affiliation': ""Unité de Recherche Clinique-Centre Investigation Clinique, APHP, Hôpital Necker-Enfants malades, Paris, France; Université de Paris, EA 7323 Pharmacologie et thérapeutique de l'enfant et de la femme enceinte, Paris, France.""}, {'ForeName': 'Hendy', 'Initials': 'H', 'LastName': 'Abdoul', 'Affiliation': ""Unité de Recherche Clinique-Centre Investigation Clinique, APHP, Hôpital Necker-Enfants malades, Paris, France; Université de Paris, EA 7323 Pharmacologie et thérapeutique de l'enfant et de la femme enceinte, Paris, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Masson', 'Affiliation': 'Unité de Recherche Clinique-Centre Investigation Clinique, APHP, Hôpital Necker-Enfants malades, Paris, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Choupeaux', 'Affiliation': 'Unité de Recherche Clinique-Centre Investigation Clinique, APHP, Hôpital Necker-Enfants malades, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Dufour', 'Affiliation': 'Unité de Recherche Clinique-Centre Investigation Clinique, APHP, Hôpital Necker-Enfants malades, Paris, France.'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Gastli', 'Affiliation': 'Plateforme COVID IDF, AP-HP. Centre Université de Paris, F-75014 Paris, France.'}, {'ForeName': 'Severine Mercier', 'Initials': 'SM', 'LastName': 'Delarue', 'Affiliation': 'Service de Virologie, AP-HP, Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'Marie Laure', 'Initials': 'ML', 'LastName': 'Néré', 'Affiliation': 'Service de Virologie, AP-HP, Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Minier', 'Affiliation': 'Service de Virologie, AP-HP, Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Gabassi', 'Affiliation': 'Service de Virologie, AP-HP, Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Salmona', 'Affiliation': 'Service de Virologie, AP-HP, Hôpital Saint Louis, Paris, France; Université de Paris, INSERM, Equipe INSIGHT, U976, Paris, France.'}, {'ForeName': 'Malika', 'Initials': 'M', 'LastName': 'Seguineau', 'Affiliation': 'PRODISS, Syndicat national du spectacle vivant et de variété, Paris, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schmitt', 'Affiliation': 'PRODISS, Syndicat national du spectacle vivant et de variété, Paris, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Tonglet', 'Affiliation': 'Weezevent, F-93200 Saint-Denis, France.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Olivier', 'Affiliation': 'Weezevent, F-93200 Saint-Denis, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Poyart', 'Affiliation': 'Université de Paris, INSERM, Institut Cochin 1016, Paris, France; Bactériologie, AP-HP Centre, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Jerôme', 'Initials': 'J', 'LastName': 'Le Goff', 'Affiliation': 'Service de Virologie, AP-HP, Hôpital Saint Louis, Paris, France; Université de Paris, INSERM, Equipe INSIGHT, U976, Paris, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Lescure', 'Affiliation': 'Service de maladies infectieuses et tropicales, AP-HP, Hôpital Bichat, Paris, France; Université de Paris, INSERM, IAME, Paris, France.'}, {'ForeName': 'Solen', 'Initials': 'S', 'LastName': 'Kernéis', 'Affiliation': 'Equipe de Prévention du Risque Infectieux, AP-HP, Hôpital Bichat, Paris, France; AP-HP, Hôpital Bichat, Paris, France; Epidemiology and Modelling of Antibiotic Evasion, Institut Pasteur, Paris, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Tréluyer', 'Affiliation': 'Unité de Recherche Clinique-Centre Investigation Clinique, APHP, Hôpital Necker-Enfants malades, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(21)00673-3']
1381,34875666,Evaluation of a Stepped Care Approach to Manage Depression and Diabetes Distress in Patients with Type 1 Diabetes and Type 2 Diabetes: Results of a Randomized Controlled Trial (ECCE HOMO Study).,"INTRODUCTION


Depression is a common and serious complication of diabetes. Treatment approaches addressing the specific demands of affected patients are scarce.
OBJECTIVE


The aim of this work was to test whether a stepped care approach for patients with diabetes and depression and/or diabetes distress yields greater depression reduction than treatment-as-usual.
METHODS


Two-hundred and sixty patients with diabetes and elevated depressive symptoms (CES-D ≥16) and/or elevated diabetes distress (PAID ≥40) were randomized to stepped care for depression or diabetes treatment-as-usual. The primary outcome was the rate of meaningful depression reduction at the 12-month follow-up according to the HAMD (score <9 or reduction by ≥50%). Secondary outcomes were changes in depression scores (HAMD/CES-D), diabetes distress (PAID), diabetes acceptance (AADQ), well-being (WHO-5), quality of life (EQ-5D/SF-36), self-care behavior (SDSCA/DSMQ), HbA1c, and biomarkers of inflammation.
RESULTS


One-hundred and thirty-one individuals were assigned to stepped care and 129 to treatment-as-usual. Overall, 15.4% were lost to follow-up. Meaningful depression reduction was observed in 80.2 versus 51.2% in stepped care versus treatment-as-usual (p < 0.001, intention-to-treat analysis). Of the secondary measures, the HAMD (∆ -3.2, p < 0.001), WHO-5 (∆ 1.5, p = 0.007), and AADQ (∆ -1.0, p = 0.008) displayed significant treatment effects, while effects on CES-D (∆ -2.3, p = 0.065), PAID (∆ -3.5, p = 0.109), and SDSCA (∆ 0.20, p = 0.081) were not significantly different. Both groups showed comparable changes in EQ-5D/SF-36, DSMQ, HbA1c, and biomarkers of inflammation (all p ≥ 0.19).
CONCLUSIONS


The stepped care approach improved depression, well-being, and acceptance. The results support that increasing treatment intensity on demand is effective and can help provide more optimal treatment. The inclusion of diabetes-specific interventions may be beneficial for patients with diabetes and elevated depression.",2022,"Of the secondary measures, the HAMD (∆ -3.2, p < 0.001), WHO-5","['patients with diabetes and depression and/or diabetes distress yields greater depression reduction than treatment-as-usual', 'Patients with Type 1 Diabetes and Type 2 Diabetes', 'Two-hundred and sixty patients with diabetes and elevated depressive symptoms (CES-D ≥16) and/or elevated diabetes distress (PAID ≥40', 'One-hundred and thirty-one individuals', 'patients with diabetes and elevated depression']","['stepped care approach', 'stepped care for depression or diabetes treatment-as-usual', 'Stepped Care Approach']","['changes in depression scores (HAMD/CES-D), diabetes distress (PAID), diabetes acceptance (AADQ), well-being (WHO-5), quality of life (EQ-5D/SF-36), self-care behavior (SDSCA/DSMQ), HbA1c, and biomarkers of inflammation', 'rate of meaningful depression reduction', 'CES-D (∆', 'depression, well-being, and acceptance', 'Meaningful depression reduction', 'HAMD', 'EQ-5D/SF-36, DSMQ, HbA1c, and biomarkers of inflammation', 'AADQ', 'WHO-5']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",260.0,0.148298,"Of the secondary measures, the HAMD (∆ -3.2, p < 0.001), WHO-5","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schmitt', 'Affiliation': 'Research Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim, Bad Mergentheim, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Kulzer', 'Affiliation': 'Research Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim, Bad Mergentheim, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Reimer', 'Affiliation': 'Research Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim, Bad Mergentheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Herder', 'Affiliation': 'German Center for Diabetes Research (DZD), Muenchen-Neuherberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': 'German Center for Diabetes Research (DZD), Muenchen-Neuherberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Haak', 'Affiliation': 'Research Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim, Bad Mergentheim, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Hermanns', 'Affiliation': 'Research Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim, Bad Mergentheim, Germany.'}]",Psychotherapy and psychosomatics,['10.1159/000520319']
1382,34813414,"Prostacyclin in Intubated Patients with COVID-19 and Severe Endotheliopathy: A Multicenter, Randomized Clinical Trial.","Rationale:  The mortality in patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who require mechanical ventilation remains high, and endotheliopathy has been implicated.  Objectives:  To determine the effect of prostacyclin infusion in mechanically ventilated patients infected with SARS-CoV-2 with severe endotheliopathy.  Methods:  We conducted a multicenter, randomized clinical trial in adults infected with coronavirus disease (COVID-19) who required mechanical ventilation and had a plasma level of thrombomodulin >4 ng/ml; patients were randomized to 72-hour infusion of prostacyclin 1 ng/kg/min or placebo.  Measurements and Main Results:  The main outcome was the number of days alive and without mechanical ventilation within 28 days. Key secondary outcomes were 28-day mortality and serious adverse events within 7 days. Eighty patients were randomized (41 prostacyclin and 39 placebo). The median number of days alive without mechanical ventilation at 28 days was 16.0 days (SD, 12) versus 5.0 days (SD, 10) (difference of the medians, 10.96 days; 95% confidence interval [CI], -5 to 21;  P  = 0.07) in the prostacyclin and the placebo groups, respectively. The 28-day mortality was 21.9% versus 43.6% in the prostacyclin and the placebo groups, respectively (risk ratio, 0.50; 95% CI, 0.24 to 0.96;  P  = 0.06). The incidence of serious adverse events within 7 days was 2.4% versus 12.8% (risk ratio, 0.19; 95% CI, 0.001 to 1.11;  P  = 0.10) in the prostacyclin and the placebo groups, respectively.  Conclusions:  Prostacyclin was not associated with a significant reduction in the number of days alive and without mechanical ventilation within 28 days. The point estimates, however, favored the prostacyclin group in all analyses, including 28-day mortality, warranting further investigation in larger trials. Clinical trial registered with www.clinicaltrials.gov (NCT04420741); EudraCT Identifier: 2020-001296-33.",2022,"The 28-day mortality was 21.9% versus 43.6% in the prostacyclin and the placebo groups, respectively (risk ratio 0.50 [95% CI 0.24 to 0.96] P=0.056).","['COVID-19 infected adults requiring mechanical ventilation having a plasma level of thrombomodulin ', 'Eighty patients were randomized (41', 'Mechanically Ventilated Patients with COVID-19 and Severe Endotheliopathy', 'mechanically ventilated SARS-CoV-2 infected patients with severe endotheliopathy']","['prostacyclin, 39 placebo', 'Prostacyclin', 'prostacyclin 1 ng/kg/min or placebo', 'prostacyclin infusion', 'placebo', 'prostacyclin']","['number of days alive and without mechanical ventilation within 28-days', 'number of days alive without mechanical ventilation', 'incidence of serious adverse events', '28-day mortality', '28-day mortality and serious adverse events']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}]","[{'cui': 'C0033567', 'cui_str': 'Epoprostenol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1320753', 'cui_str': 'ng/kg/min'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",80.0,0.69691,"The 28-day mortality was 21.9% versus 43.6% in the prostacyclin and the placebo groups, respectively (risk ratio 0.50 [95% CI 0.24 to 0.96] P=0.056).","[{'ForeName': 'Pär I', 'Initials': 'PI', 'LastName': 'Johansson', 'Affiliation': 'Department of Clinical Immunology.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Søe-Jensen', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital-North Zealand, Copenhagen, Denmark.'}, {'ForeName': 'Niels E', 'Initials': 'NE', 'LastName': 'Clausen', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Copenhagen, Denmark.'}, {'ForeName': 'Klaus T', 'Initials': 'KT', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Intensive Care. Copenhagen University Hospital-Amager and Hvidovre, Copenhagen, Denmark; and.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Stensballe', 'Affiliation': 'Department of Clinical Immunology.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202108-1855OC']
1383,34814113,Increasing Oxygen Uptake in Cross-Country Skiers by Speed Variation in Work Intervals.,"PURPOSE


Accumulated time at a high percentage of peak oxygen consumption (VO2peak) is important for improving performance in endurance athletes. The present study compared the acute physiological and perceived effects of performing high-intensity intervals with roller ski double poling containing work intervals with (1) fast start followed by decreasing speed (DEC), (2) systematic variation in exercise intensity (VAR), and (3) constant speed (CON).
METHODS


Ten well-trained cross-country skiers (double-poling VO2peak 69.6 [3.5] mL·min-1·kg-1) performed speed- and duration-matched DEC, VAR, and CON on 3 separate days in a randomized order (5 × 5-min work intervals and 3-min recovery).
RESULTS


DEC and VAR led to longer time ≥90% VO2peak (P = .016 and P = .033, respectively) and higher mean %VO2peak (P = .036, and P = .009) compared with CON, with no differences between DEC and VAR (P = .930 and P = .759, respectively). VAR, DEC, and CON led to similar time ≥90% of peak heart rate (HRpeak), mean HR, mean breathing frequency, mean ventilation, and mean blood lactate concentration ([La-]). Furthermore, no differences between sessions were observed for perceptual responses, such as mean rate of perceived exertion, session rate of perceived exertion or pain score (all Ps > .147).
CONCLUSIONS


In well-trained XC skiers, DEC and VAR led to longer time ≥90% of VO2peak compared with CON, without excessive perceptual effort, indicating that these intervals can be a good alternative for accumulating more time at a high percentage of VO2peak and at the same time mimicking the pronounced variation in exercise intensities experienced during XC-skiing competitions.",2021,"RESULTS


DEC and VAR led to longer time ≥90% VO2peak (P = .016 and P = .033, respectively) and higher mean %VO2peak (P = .036, and P = .009) compared with CON, with no differences between DEC and VAR (P = .930 and P = .759, respectively).","['Ten well-trained cross-country skiers (double-poling', 'endurance athletes']",['CON'],"['peak heart rate (HRpeak), mean HR, mean breathing frequency, mean ventilation, and mean blood lactate concentration ([La', 'perceptual responses, such as mean rate of perceived exertion, session rate of perceived exertion or pain score', 'speed (DEC), (2)\xa0systematic variation in exercise intensity (VAR), and (3)\xa0constant speed (CON']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0425040', 'cui_str': 'Skier'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]",10.0,0.0569896,"RESULTS


DEC and VAR led to longer time ≥90% VO2peak (P = .016 and P = .033, respectively) and higher mean %VO2peak (P = .036, and P = .009) compared with CON, with no differences between DEC and VAR (P = .930 and P = .759, respectively).","[{'ForeName': 'Bent R', 'Initials': 'BR', 'LastName': 'Rønnestad', 'Affiliation': ''}, {'ForeName': 'Timo Andre', 'Initials': 'TA', 'LastName': 'Bakken', 'Affiliation': ''}, {'ForeName': 'Vetle', 'Initials': 'V', 'LastName': 'Thyli', 'Affiliation': ''}, {'ForeName': 'Joar', 'Initials': 'J', 'LastName': 'Hansen', 'Affiliation': ''}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Ellefsen', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hammarstrøm', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2021-0226']
1384,34818660,Acceptance and Benefits of Two Different Strategies to Timely Integrate Specialist Palliative Care into Routine Cancer Care: A Randomized Pilot Study.,"BACKGROUND/AIMS


The aim of this study is to investigate the acceptance and benefits of two different strategies to timely integrate specialist palliative care (SPC) in routine cancer care: commonly recommended early SPC counselling versus an informational brochure plus SPC counselling upon patients' request.
METHODS


Patients diagnosed with incurable cancer within the last 6-12 weeks were sequentially randomized. Endpoints were acceptance of the two strategies after 3 months as well as the use of SPC counselling and psychosocial support, presence of advance directives, palliative care outcome (Integrated Palliative care Outcome Scale [IPOS]), and psychosocial distress (Distress Thermometer [DT]) after 3 and 6 months. In a qualitative part, SPC consultations were analyzed using a content analysis.
RESULTS


Overall, 43 patients received SPC counselling and 37 a brochure with SPC counselling on demand. In the brochure group, only one patient later registered for SPC counselling from own initiative. SPC timing was appropriate in 70% of patients (75% counselling/61% brochure, n.s.). Sufficiency, helpfulness and relevance of information, provision of security, and help with finding contacts for specific support were perceived adequate in both groups. No significant differences were found regarding potential effects of the interventions on IPOS or DT after 3 and 6 months. The use of psychosocial support was comparable between the groups and 4 patients had new advance directives (3 counselling/1 brochure). Five key themes of SPC consultations were identified: symptoms, rapport, coping, illness understanding, and advance care planning.
CONCLUSIONS


Both SPC integration strategies were well accepted. However, patients seem not to benefit from a brochure in terms of initiating SPC counselling timely after a palliative cancer diagnosis.",2022,"Five key themes of SPC consultations were identified: symptoms, rapport, coping, illness understanding, and advance care planning.
","['routine cancer care', 'Patients diagnosed with incurable cancer within the last 6-12 weeks', '43 patients received']","['SPC counselling and 37 a brochure with SPC counselling', 'timely integrate specialist palliative care (SPC', 'SPC counselling versus an informational brochure plus SPC counselling']","['symptoms, rapport, coping, illness understanding, and advance care planning', 'SPC counselling and psychosocial support, presence of advance directives, palliative care outcome (IPOS), psychosocial distress (DT', 'IPOS or DT']","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.0753683,"Five key themes of SPC consultations were identified: symptoms, rapport, coping, illness understanding, and advance care planning.
","[{'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'Ullrich', 'Affiliation': 'Palliative Care Unit, Department of Oncology, Hematology and BMT, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Svenja', 'Initials': 'S', 'LastName': 'Wilde', 'Affiliation': 'Palliative Care Unit, Department of Oncology, Hematology and BMT, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Sinn', 'Affiliation': 'Department of Oncology, Hematology and BMT, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Gebhardt', 'Affiliation': 'Department of Palliative Care, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Janna-Lisa', 'Initials': 'JL', 'LastName': 'Velthaus', 'Affiliation': 'Department of Oncology, Hematology and BMT, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Gerlach', 'Affiliation': 'Palliative Care Unit, Department of Oncology, Hematology and BMT, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'Department of Oncology, Hematology and BMT, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Oechsle', 'Affiliation': 'Palliative Care Unit, Department of Oncology, Hematology and BMT, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Oncology research and treatment,['10.1159/000521077']
1385,34821020,Dose tapering to withdrawal stage and long-term efficacy and safety of hetrombopag for the treatment of immune thrombocytopenia: Results from an open-label extension study.,"BACKGROUND


The efficacy of hetrombopag in Chinese patients with immune thrombocytopenia (ITP) has been demonstrated in a randomized, double-blind, placebo-controlled, multicenter, phase III trial (NCT03222843).
OBJECTIVE


This study aimed to report comprehensive data on a ≤6-week dose tapering to withdrawal (Stage 3) and an additional 24-week long-term extension period (Stage 4) in this phase III trial.
PATIENTS/METHODS


Patients who fulfilled the screening criteria were eligible to enter Stage 3 or 4. During Stage 3, hetrombopag was gradually tapered to withdrawal. During Stage 4, hetrombopag treatment was initiated at 2.5, 3.75, 5, or 7.5 mg once daily. The efficacy endpoints during Stage 3 or 4 and the safety profile during the entire treatment period were reported.
RESULTS


Among 194 patients who entered Stage 3, 171 (88.1%) relapsed. The median time to the first relapse since the start of Stage 3 was 15.0 days (95% CI, 14.0-16.0). In Stage 4, 144 (42.5%) patients responded at ≥75% of their assessments and 254 (74.9%) patients achieved platelet count ≥30 × 10 9  /L at least once, which was at least twice their baseline platelet count in the hetrombopag group (n = 339). The most common adverse events were upper respiratory tract infection (53.1%), thrombocytopenia (27.1%), and urinary tract infection (21.2%) in the hetrombopag group.
CONCLUSION


The majority of patients who experienced dose tapering to withdrawal experienced a relapse. Long-term treatment with hetrombopag was effective in increasing and maintaining platelet count within the desired range in Chinese adults with ITP. Hetrombopag was well tolerated.",2022,"The most common adverse events were upper respiratory tract infection (53.1%), thrombocytopenia (27.1%), and urinary tract infection (21.2%) in the hetrombopag group.
","['Patients who fulfilled the screening criteria were eligible to enter Stage 3 or 4', 'Chinese adults with ITP', 'Chinese patients with immune thrombocytopenia (ITP', 'immune thrombocytopenia', '194 patients who entered Stage 3, 171 (88.1%) relapsed']","['hetrombopag', 'placebo']","['thrombocytopenia', 'urinary tract infection', 'tolerated', 'relapse', 'median time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C4505753', 'cui_str': 'hetrombopag'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.156805,"The most common adverse events were upper respiratory tract infection (53.1%), thrombocytopenia (27.1%), and urinary tract infection (21.2%) in the hetrombopag group.
","[{'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Mei', 'Affiliation': 'Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiaofan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Thrombosis and Hemostasis Center, State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Tianjin Laboratory of Blood Disease Gene Therapy, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Institute of Hematology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Hematopathology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Guangxun', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': ""The Blood Internal Medicine, The First Affiliated Hospital of Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Hematology Department, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Ruibin', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': 'Hematology Department, The First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Linhua', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Hematology, The Second Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Jianda', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Hematology, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': 'Department of Hematology, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Yazhou', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Hematology Department, Baoji Central Hospital, Baoji, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Hematopathology, The Second Affiliated Hospital of Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Hematopathology, Shaanxi Provincial People's Hospital, Xi'an, China.""}, {'ForeName': 'Depei', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Hematology Department, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Liansheng', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Hematology Department, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Changcheng', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Hematology Department, The First Affiliated Hospital of USTC, Hefei, China.'}, {'ForeName': 'Xuliang', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Department of Hematology, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Hematology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Hematology, The Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Hematology, The Second Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Hematology, First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Sujun', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Hematology, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Hematology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ""Hematology Department, Wuxi People's Hospital, Wuxi, China.""}, {'ForeName': 'Qingzhi', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Hematology Department, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Ruixiang', 'Initials': 'R', 'LastName': 'Xia', 'Affiliation': 'Hematology Department, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xiaobao', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ""Hematology Department, The First People's Hospital of Changzhou, Changzhou, China.""}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Hematology, The Second Affiliated Hospital of Military Medical University PLA, Chongqing, China.'}, {'ForeName': 'Yuansong', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Hematology & Oncology, China-Japan Union Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Hematology Department, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Junye', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': 'Clinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.'}, {'ForeName': 'Runzi', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Clinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Clinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Niu', 'Affiliation': 'Department of Hematology, Institute of Hematology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Renchi', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Thrombosis and Hemostasis Center, State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Tianjin Laboratory of Blood Disease Gene Therapy, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.15602']
1386,34823375,Incidence and Outcomes of Acute Heart Failure With Preserved Versus Reduced Ejection Fraction in SPRINT.,"BACKGROUND


In the SPRINT (Systolic Blood Pressure Intervention Trial), intensive BP treatment reduced acute decompensated heart failure (ADHF) events. Here, we report the effect on HF with preserved ejection fraction (HFpEF) and HF with reduced EF (HFrEF) and their subsequent outcomes.
METHODS


Incident ADHF was defined as hospitalization or emergency department visit, confirmed, and formally adjudicated by a blinded events committee using standardized protocols. HFpEF was defined as EF ≥45%, and HFrEF was EF <45%.
RESULTS


Among the 133 participants with incident ADHF who had EF assessment, 69 (52%) had HFpEF and 64 (48%) had HFrEF ( P  value: 0.73). During average 3.3 years follow-up in those who developed incident ADHF, rates of subsequent all-cause and HF hospital readmission and mortality were high, but there were no significant differences between those who developed HFpEF versus HFrEF. Randomization to the intensive arm had no effect on subsequent mortality or readmissions after the initial ADHF event, irrespective of EF subtype. During follow-up among participants who developed HFpEF, although relatively modest number of events limited statistical power, age was an independent predictor of all-cause mortality, and Black race independently predicted all-cause and HF hospital readmission.
CONCLUSIONS


In SPRINT, intensive BP reduction decreased both acute decompensated HFpEF and HFrEF events. After initial incident ADHF, rates of subsequent hospital admission and mortality were high and were similar for those who developed HFpEF or HFrEF. Randomization to the intensive arm did not alter the risks for subsequent all-cause, or HF events in either HFpEF or HFrEF. Among those who developed HFpEF, age and Black race were independent predictors of clinical outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01206062.",2021,"Randomization to the intensive arm did not alter the risks for subsequent all-cause, or HF events in either HFpEF or HFrEF.",['133 participants with incident ADHF'],[],"['Ejection Fraction', 'subsequent mortality or readmissions', 'rates of subsequent all-cause and HF hospital readmission and mortality', 'HF with preserved ejection fraction (HFpEF) and HF with reduced EF (HFrEF', 'Incidence and Outcomes of Acute Heart Failure', 'rates of subsequent hospital admission and mortality', 'intensive BP reduction', 'HFpEF']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",[],"[{'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",133.0,0.135264,"Randomization to the intensive arm did not alter the risks for subsequent all-cause, or HF events in either HFpEF or HFrEF.","[{'ForeName': 'Bharathi', 'Initials': 'B', 'LastName': 'Upadhya', 'Affiliation': 'Cardiovascular Medicine Section (B.U., D.W.K.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Willard', 'Affiliation': 'Biostatistics (J.J.W., L.C.L.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Lovato', 'Affiliation': 'Biostatistics (J.J.W., L.C.L.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Nephrology Section, Department of Internal Medicine (M.V.R.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology, School of Public Health (C.E.L.), University of Alabama at Birmingham.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Division of Cardiovascular Disease, Department of Medicine (S.O.), University of Alabama at Birmingham.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Division of Cardiovascular Disease, Department of Medicine (S.O.), University of Alabama at Birmingham.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Bates', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX (J.T.B.).'}, {'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Bello', 'Affiliation': 'Cardiovascular Division, Department of Medicine, Columbia University Medical Center, New York, NY (N.A.B.).'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Aurigemma', 'Affiliation': 'Cardiology, University of Massachusetts Medical School, Worcester (G.A.).'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis (K.C.J.).'}, {'ForeName': 'Carlos J', 'Initials': 'CJ', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Medicine, Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY (C.J.R.).'}, {'ForeName': 'Dominic S', 'Initials': 'DS', 'LastName': 'Raj', 'Affiliation': 'Medicine-Nephrology, George Washington University School of Medicine, Washington, DC (D.S.R.).'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Division of Nephrology, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles (A.R.).'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Tamariz', 'Affiliation': 'University of Miami Miller School of Medicine, FL (L.T.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Wiggers', 'Affiliation': 'University Hospitals Harrington Heart and Vascular Institute, Cleveland Medical Center, OH (A.W.).'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'Cardiovascular Medicine Section (B.U., D.W.K.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.121.008322']
1387,34824765,Artificial Intelligence Algorithm-Based Computed Tomography Images in the Evaluation of the Curative Effect of Enteral Nutrition after Neonatal High Intestinal Obstruction Operation.,"In this study, CT image technology based on level set intelligent segmentation algorithm was used to evaluate the postoperative enteral nutrition of neonatal high intestinal obstruction and analyze the clinical treatment effect of high intestinal obstruction, so as to provide a reasonable research basis for the clinical application of neonatal high intestinal obstruction. 60 children with high intestinal obstruction treated in the hospital were selected as the research objects. Based on the postoperative enteral nutrition treatment, they were divided into control group (noncatheterization group)-parenteral nutrition support. In the observation group, gastric tube was placed through nose for nutritional support. Then, CT images based on level set segmentation algorithm were used to compare the intestinal recovery of the two groups, and the biochemical indexes and hospitalization were compared. The level set algorithm can accurately segment the lesions in CT images. The segmentation time of the level set algorithm was shorter than that of the traditional algorithm (24.34 ± 2.01 s vs. 75.21 ± 5.91 s), and the segmentation accuracy was higher than that of the traditional algorithm (84.71 ± 3.91% vs. 70.04 ± 3.71%,  P  < 0.05). The weight of children in the observation group (100 ± 7 g) was higher than that in the control group (54 ± 5 g), and the ICU monitoring time (12.01 ± 2.65 days) and the hospital stay (17.82 ± 3.11 days) were shorter than those in the control group (13.42 ± 2.95 days, 19.13 ± 3.22 days, all  P  < 0.05). The level set segmentation algorithm can accurately segment the CT image, so that the disease location and its contour can be displayed more clearly. Moreover, the nasal placement of jejunal nutrition tube can effectively improve the intestinal function of children, maintain the steady-state environment of intestinal bacterial growth, and significantly improve the clinical treatment effect, which is worthy of clinical application and promotion.",2021,"The segmentation time of the level set algorithm was shorter than that of the traditional algorithm (24.34 ± 2.01 s vs. 75.21 ± 5.91 s), and the segmentation accuracy was higher than that of the traditional algorithm (84.71 ± 3.91% vs. 70.04 ± 3.71%,  P  < 0.05).","['60 children with high intestinal obstruction treated in the hospital were selected as the research objects', 'Enteral Nutrition after Neonatal High Intestinal Obstruction Operation']",['Artificial Intelligence Algorithm-Based Computed Tomography Images'],"['segmentation time of the level set algorithm', 'weight of children', 'ICU monitoring time', 'hospital stay', 'segmentation accuracy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021843', 'cui_str': 'Intestinal obstruction'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",60.0,0.0173348,"The segmentation time of the level set algorithm was shorter than that of the traditional algorithm (24.34 ± 2.01 s vs. 75.21 ± 5.91 s), and the segmentation accuracy was higher than that of the traditional algorithm (84.71 ± 3.91% vs. 70.04 ± 3.71%,  P  < 0.05).","[{'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': ""Pediatric Surgery, Department of General Surgery, Hebei Children's Hospital, Shijiazhuang 050000, Hebei, China.""}, {'ForeName': 'Zhaolong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Pediatric Surgery, Department of General Surgery, Hebei Children's Hospital, Shijiazhuang 050000, Hebei, China.""}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Pediatric Surgery, Department of General Surgery, Hebei Children's Hospital, Shijiazhuang 050000, Hebei, China.""}, {'ForeName': 'Bobo', 'Initials': 'B', 'LastName': 'Niu', 'Affiliation': ""Pediatric Surgery, Department of General Surgery, Hebei Children's Hospital, Shijiazhuang 050000, Hebei, China.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Pediatric Surgery, Department of General Surgery, Hebei Children's Hospital, Shijiazhuang 050000, Hebei, China.""}, {'ForeName': 'Pengju', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Pediatric Surgery, Department of General Surgery, Hebei Children's Hospital, Shijiazhuang 050000, Hebei, China.""}, {'ForeName': 'Huizhong', 'Initials': 'H', 'LastName': 'Niu', 'Affiliation': ""Pediatric Surgery, Department of General Surgery, Hebei Children's Hospital, Shijiazhuang 050000, Hebei, China.""}]",Journal of healthcare engineering,['10.1155/2021/7096286']
1388,34826572,Effect of transcutaneous electrical nerve stimulation (TENS) on knee pain and physical function in patients with symptomatic knee osteoarthritis: the ETRELKA randomized clinical trial.,"OBJECTIVE


To determine the effectiveness of TENS at relieving pain and improving physical function as compared to placebo TENS, and to determine its safety, in patients with knee osteoarthritis.
METHODS


Multi-centre, parallel, 1:1 randomized, double-blind, placebo-controlled clinical trial conducted in six outpatient clinics in Switzerland. We included 220 participants with knee osteoarthritis recruited between October 15, 2012, and October 15, 2014. Patients were randomized to 3 weeks of treatment with TENS (n = 108) or placebo TENS (n = 112). Our pre-specified primary endpoint was knee pain at the end of 3-weeks treatment assessed with the WOMAC pain subscale. Secondary outcome measures included WOMAC physical function subscale and safety outcomes.
RESULTS


There was no difference between TENS and placebo TENS in WOMAC pain at the end of treatment (mean difference -0.06; 95%CI -0.41 to 0.29; P = 0.74), nor throughout the trial duration (P = 0.98). Subgroup analyses did not indicate an interaction between patient/treatment characteristics and treatment effect on WOMAC pain at the end of treatment (P-interaction ≥0.22). The occurrence of adverse events was similar across groups, with 10.4% and 10.6% of patients reporting events in the TENS and placebo TENS groups, respectively (P = 0.95). No relevant differences were observed in secondary outcomes.
CONCLUSIONS


TENS does not improve knee osteoarthritis pain when compared to placebo TENS. Therapists should consider other potentially more effective treatment modalities to decrease knee osteoarthritis pain and facilitate strengthening and aerobic exercise. Our findings are conclusive and further trials comparing TENS and placebo TENS in this patient population are not necessary.",2022,"There was no difference between TENS and placebo TENS in WOMAC pain at the end of treatment (mean difference -0.06; 95%CI -0.41 to 0.29; p=0.74), nor throughout the trial duration (p=0.98).","['220 participants with knee osteoarthritis recruited between October 15, 2012, and October 15, 2014', 'patients with symptomatic knee osteoarthritis', '6 outpatient clinics in Switzerland', 'patients with knee osteoarthritis']","['placebo TENS', 'placebo', 'TENS', 'transcutaneous electrical nerve stimulation (TENS']","['WOMAC physical function subscale and safety outcomes', 'knee osteoarthritis pain and facilitate strengthening and aerobic exercise', 'knee pain and physical function', 'WOMAC pain subscale', 'occurrence of adverse events', 'knee pain', 'WOMAC pain', 'knee osteoarthritis pain']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",220.0,0.670476,"There was no difference between TENS and placebo TENS in WOMAC pain at the end of treatment (mean difference -0.06; 95%CI -0.41 to 0.29; p=0.74), nor throughout the trial duration (p=0.98).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Reichenbach', 'Affiliation': 'Institute for Social and Preventive Medicine (ISPM), University of Bern, Switzerland; Department of Rheumatology and Immunology, Bern University Hospital, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Institute of Health Policy, Management, and Evaluation, Department of Medicine, University of Toronto, Toronto, Canada; Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada.""}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Hincapié', 'Affiliation': ""Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada; Department of Chiropractic Medicine, Faculty of Medicine, University of Zurich and Balgrist University Hospital, Zurich, Switzerland; Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich, Zurich, Switzerland.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schneider', 'Affiliation': 'Institute for Social and Preventive Medicine (ISPM), University of Bern, Switzerland; Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'D N', 'Initials': 'DN', 'LastName': 'Meli', 'Affiliation': 'General Practice, Huttwil, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schürch', 'Affiliation': 'Institute for Social and Preventive Medicine (ISPM), University of Bern, Switzerland; CTU Bern, University of Bern, Switzerland; Department of Entomology, Virginia Tech Polytechnic Institute & State University, Blacksburg, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Streit', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lucas', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, University of Amsterdam, Faculty of Medicine (AMC), Amsterdam, the Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mebes', 'Affiliation': 'Physio Postmarkt AG, Grenchen, Switzerland.'}, {'ForeName': 'A W S', 'Initials': 'AWS', 'LastName': 'Rutjes', 'Affiliation': 'Institute for Social and Preventive Medicine (ISPM), University of Bern, Switzerland.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ""Institute of Health Policy, Management, and Evaluation, Department of Medicine, University of Toronto, Toronto, Canada; Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada; Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland. Electronic address: bruno.dacosta@utoronto.ca.""}]",Osteoarthritis and cartilage,['10.1016/j.joca.2021.10.015']
1389,34826381,"Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial.","BACKGROUND


Additional safe and efficacious vaccines are needed to control the COVID-19 pandemic. We aimed to analyse the efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate.
METHODS


HERALD is a randomised, observer-blinded, placebo-controlled, phase 2b/3 clinical trial conducted in 47 centres in ten countries in Europe and Latin America. By use of an interactive web response system and stratification by country and age group (18-60 years and ≥61 years), adults with no history of virologically confirmed COVID-19 were randomly assigned (1:1) to receive intramuscularly either two 0·6 mL doses of CVnCoV containing 12 μg of mRNA or two 0·6 mL doses of 0·9% NaCl (placebo) on days 1 and 29. The primary efficacy endpoint was the occurrence of a first episode of virologically confirmed symptomatic COVID-19 of any severity and caused by any strain from 15 days after the second dose. For the primary endpoint, the trial was considered successful if the lower limit of the CI was greater than 30%. Key secondary endpoints were the occurrence of a first episode of virologically confirmed moderate-to-severe COVID-19, severe COVID-19, and COVID-19 of any severity by age group. Primary safety outcomes were solicited local and systemic adverse events within 7 days after each dose and unsolicited adverse events within 28 days after each dose in phase 2b participants, and serious adverse events and adverse events of special interest up to 1 year after the second dose in phase 2b and phase 3 participants. Here, we report data up to June 18, 2021. The study is registered at ClinicalTrials.gov, NCT04652102, and EudraCT, 2020-003998-22, and is ongoing.
FINDINGS


Between Dec 11, 2020, and April 12, 2021, 39 680 participants were enrolled and randomly assigned to receive either CVnCoV (n=19 846) or placebo (n=19 834), of whom 19 783 received at least one dose of CVnCoV and 19 746 received at least one dose of placebo. After a mean observation period of 48·2 days (SE 0·2), 83 cases of COVID-19 occurred in the CVnCoV group (n=12 851) in 1735·29 person-years and 145 cases occurred in the placebo group (n=12 211) in 1569·87 person-years, resulting in an overall vaccine efficacy against symptomatic COVID-19 of 48·2% (95·826% CI 31·0-61·4; p=0·016). Vaccine efficacy against moderate-to-severe COVID-19 was 70·7% (95% CI 42·5-86·1; CVnCoV 12 cases in 1735·29 person-years, placebo 37 cases in 1569·87 person-years). In participants aged 18-60 years, vaccine efficacy against symptomatic disease was 52·5% (95% CI 36·2-64·8; CVnCoV 71 cases in 1591·47 person-years, placebo, 136 cases in 1449·23 person-years). Too few cases occurred in participants aged 61 years or older (CVnCoV 12, placebo nine) to allow meaningful assessment of vaccine efficacy. Solicited adverse events, which were mostly systemic, were more common in CVnCoV recipients (1933 [96·5%] of 2003) than in placebo recipients (1344 [67·9%] of 1978), with 542 (27·1%) CVnCoV recipients and 61 (3·1%) placebo recipients reporting grade 3 solicited adverse events. The most frequently reported local reaction after any dose in the CVnCoV group was injection-site pain (1678 [83·6%] of 2007), with 22 grade 3 reactions, and the most frequently reported systematic reactions were fatigue (1603 [80·0%] of 2003) and headache (1541 [76·9%] of 2003). 82 (0·4%) of 19 783 CVnCoV recipients reported 100 serious adverse events and 66 (0·3%) of 19 746 placebo recipients reported 76 serious adverse events. Eight serious adverse events in five CVnCoV recipients and two serious adverse events in two placebo recipients were considered vaccination-related. None of the fatal serious adverse events reported (eight in the CVnCoV group and six in the placebo group) were considered to be related to study vaccination. Adverse events of special interest were reported for 38 (0·2%) participants in the CVnCoV group and 31 (0·2%) participants in the placebo group. These events were considered to be related to the trial vaccine for 14 (<0·1%) participants in the CVnCoV group and for five (<0·1%) participants in the placebo group.
INTERPRETATION


CVnCoV was efficacious in the prevention of COVID-19 of any severity and had an acceptable safety profile. Taking into account the changing environment, including the emergence of SARS-CoV-2 variants, and timelines for further development, the decision has been made to cease activities on the CVnCoV candidate and to focus efforts on the development of next-generation vaccine candidates.
FUNDING


German Federal Ministry of Education and Research and CureVac.",2022,"INTERPRETATION


CVnCoV was efficacious in the prevention of COVID-19 of any severity and had an acceptable safety profile.","[' 39\u2009680 participants', ' 136 cases in 1449·23 person-years', '37 cases in 1569·87 person-years', 'country and age group (18-60 years and ≥61 years), adults with no history of virologically confirmed COVID-19', '47 centres in ten countries in Europe and Latin America', '82', 'participants aged 18-60 years', 'Between Dec 11, 2020, and April 12, 2021', 'ten countries in Europe and Latin America (HERALD', 'participants aged 61 years or older (CVnCoV 12, placebo nine']","['CVnCoV SARS-CoV-2 mRNA vaccine candidate', 'CVnCoV containing 12 μg of mRNA or two 0·6 mL doses of 0·9% NaCl (placebo', 'CVnCoV SARS-CoV-2 mRNA vaccine', 'CVnCoV', 'placebo']","['vaccine efficacy against symptomatic disease', 'serious adverse events', '100 serious adverse events', 'fatal serious adverse events', 'occurrence of a first episode of virologically confirmed moderate-to-severe COVID-19, severe COVID-19, and COVID-19 of any severity', 'serious adverse events and adverse events of special interest', 'overall vaccine efficacy against symptomatic COVID-19', 'local reaction', 'solicited local and systemic adverse events within 7 days after each dose and unsolicited adverse events', 'Adverse events of special interest', 'headache', 'occurrence of a first episode of virologically confirmed symptomatic COVID-19 of any severity and caused by any strain', 'efficacy and safety', 'Efficacy and safety', 'Vaccine efficacy against moderate-to-severe COVID-19']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1959973', 'cui_str': 'Percent sodium chloride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",39680.0,0.680908,"INTERPRETATION


CVnCoV was efficacious in the prevention of COVID-19 of any severity and had an acceptable safety profile.","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kremsner', 'Affiliation': 'Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon; German Center for Infection Research, Tübingen, Germany. Electronic address: peter.kremsner@uni-tuebingen.de.'}, {'ForeName': 'Rodolfo Andrés', 'Initials': 'RA', 'LastName': 'Ahuad Guerrero', 'Affiliation': 'Corporacion Medica de General San Martin, Buenos Aires, Argentina.'}, {'ForeName': 'Eunate', 'Initials': 'E', 'LastName': 'Arana-Arri', 'Affiliation': 'Biocruces Health Research Institute, Barakaldo, Bizkaia, Spain; Scientific Coordination Unit, Cruces University Hospital, Osakidetza, Barakaldo, Spain.'}, {'ForeName': 'Gustavo Jose', 'Initials': 'GJ', 'LastName': 'Aroca Martinez', 'Affiliation': 'Postgraduate School of Nephrology, Clínica de la Costa y Universidad Simón Bolívar, Barranquilla, Colombia.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Chandler', 'Affiliation': 'Cevaxin, Panama City, Panama.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Corral', 'Affiliation': 'Instituto de Investigaciones Clinicas de Mar del Plata, Mar del Plata, Argentina.'}, {'ForeName': 'Eddie Jan Louis', 'Initials': 'EJL', 'LastName': 'De Block', 'Affiliation': 'Cohezio, Brussels, Belgium.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Ecker', 'Affiliation': 'Instituto de Investigación Nutricional, Lima, Peru.'}, {'ForeName': 'Julian Justin', 'Initials': 'JJ', 'LastName': 'Gabor', 'Affiliation': 'Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Carlos Alberto', 'Initials': 'CA', 'LastName': 'Garcia Lopez', 'Affiliation': 'Unidad de Medicina Especializada, San Juan del Río, Mexico.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Gonzales', 'Affiliation': 'Clinica Medica San Martin, Ica, Peru.'}, {'ForeName': 'María Angélica', 'Initials': 'MA', 'LastName': 'Granados González', 'Affiliation': 'Centro de Atención e Investigación Médica, Bogotá, Colombia.'}, {'ForeName': 'Nestor', 'Initials': 'N', 'LastName': 'Gorini', 'Affiliation': 'Haematology and Haemotherapy Diagnosis and Treatment Unit, Hospital Zonal General de Agudos Descentralizado Evita Pueblo de Berazategui, Buenos Aires, Argentina.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Grobusch', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon; German Center for Infection Research, Tübingen, Germany; Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Amsterdam University Medical Center, Amsterdam Public Health, Amsterdam Infection and Immunity, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Adrian D', 'Initials': 'AD', 'LastName': 'Hrabar', 'Affiliation': 'Instituto de Investigaciones Clínicas Quilmes, Hudson, Argentina.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Junker', 'Affiliation': 'CureVac, Tübingen, Germany.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kimura', 'Affiliation': 'CureVac, Tübingen, Germany.'}, {'ForeName': 'Claudio F', 'Initials': 'CF', 'LastName': 'Lanata', 'Affiliation': 'Instituto de Investigación Nutricional, Lima, Peru; School of Medicine, Vanderbilt University, Nashville, TN, USA; Department of Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Lehmann', 'Affiliation': 'Infection Protection Centre (ISZ) & Infection Outpatient Clinic, Innere Medizin I, Uniklinik Köln, Cologne, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Leroux-Roels', 'Affiliation': 'Center for Vaccinology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Mann', 'Affiliation': 'CureVac, Tübingen, Germany.'}, {'ForeName': 'Michel Fernando', 'Initials': 'MF', 'LastName': 'Martinez-Reséndez', 'Affiliation': 'School of Medicine and Health Sciences, Tecnologico de Monterrey, Monterrey, Mexico.'}, {'ForeName': 'Theresa J', 'Initials': 'TJ', 'LastName': 'Ochoa', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru; Center for Infectious Diseases, School of Public Health, University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Carlos Alberto', 'Initials': 'CA', 'LastName': 'Poy', 'Affiliation': 'Sanatorio Parque, Rosario, Argentina.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Reyes Fentanes', 'Affiliation': 'PanAmerican Clinical Research México, Juriquilla, Mexico.'}, {'ForeName': 'Luis Maria', 'Initials': 'LM', 'LastName': 'Rivera Mejia', 'Affiliation': 'Fundacion Dominicana de Perinatologia, Hospital Universitario Maternidad Nuestra Senora de la Altagracia, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Vida Veronica', 'Initials': 'VV', 'LastName': 'Ruiz Herrera', 'Affiliation': 'PanAmerican Clinical Research, Guadalajara, Mexico.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Sáez-Llorens', 'Affiliation': 'Clinical Research Department, Panama City, Panama; Cevaxin Research Center, Panama City, Panama; Senacyt, Panama City, Panama.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schönborn-Kellenberger', 'Affiliation': 'Cogitars, Heidelberg, Germany.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Schunk', 'Affiliation': 'Division of Infectious Diseases and Tropical Medicine, LMU Klinikum, Munich, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Sierra Garcia', 'Affiliation': 'Centro de estudios en Infectologia Pediatrica, Cali, Colombia.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Vergara', 'Affiliation': 'Primary Care Group, Biodonostia Institute for Health Research, Donostia-San Sebastián, Spain; Research Network in Health Services in Chronic Diseases, Baracaldo, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Verstraeten', 'Affiliation': 'P95 Pharmacovigilance and Epidemiology Services, Leuven, Belgium.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Vico', 'Affiliation': 'Instituto de Investigaciones Clínicas Zárate, Buenos Aires, Argentina.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'CureVac, Tübingen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(21)00677-0']
1390,34837418,"Relative bioavailability and pharmacokinetic comparison of a fixed-dose combination tablet of mosapride, pancreatin, and simethicone relative to single-component mosapride tablets in healthy Mexican subjects.","Abbott Laboratories de México S.A. de C.V. developed a new fixed-dose combination of mosapride 5 mg, pancreatin 170 mg, and simethicone 125 mg as an alternative to the mosapride monotherapy to improve overall satisfaction and adequate relief of gastrointestinal disorders symptoms and to reduce multiple pill burden. As a part of the fixed-dose combination registration process in Mexico, a pharmacokinetic and relative bioavailability study was carried out to demonstrate nonexistence of pharmacokinetic interaction when mosapride is administered alone or in combination with pancreatin and simethicone using DOSIER® (mosapride) 5-mg tablets as a reference product. Tolerability of the fixed-dose combination tablet was assessed. In this open-label, randomized, oral single-dose, two-way crossover study, 65 healthy male and female subjects received either the fixed-dose combination tablet or the reference product during each study period. The two study periods were separated by a 7-day washout period. Mosapride concentrations in plasma samples were determined using a validated ultra-performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MS/MS) method. Blood samples were collected for up to 16 h post dose. The primary evaluation criteria were C max  and AUC 0-t  for mosapride. The 90% confidence intervals for the ratio of geometric means for C max  (96.12% to 110.90%) and AUC 0-t  (99.07% to 108.06%) were within the defined acceptance limits of 75% to 133% and 80% to 125% for C max  and AUC 0-t  , respectively, indicating bioequivalence between the two products. Both products were safe and well tolerated. Therefore, mosapride in combination with pancreatin and simethicone tablet is bioequivalent to mosapride alone, and no new safety signals emerged.",2021,"The 90% confidence intervals for the ratio of geometric means for C max  (96.12%- 110.90%) and AUC 0-t  (99.07% - 108.06%) were within the defined acceptance limits of 75-133 and 80-125% for C max  and AUC 0-t  , respectively, indicating bioequivalence between the two products.","['65 healthy male and female subjects', 'Healthy Mexican Subjects']","['pancreatin and simethicone tablet', 'Mosapride, Pancreatin and Simethicone Relative to Single-component Mosapride Tablets', 'pancreatin 170 mg and simethicone', 'pancreatin and simethicone using DOSIER® (mosapride']","['Tolerability', 'overall satisfaction and adequate relief of gastrointestinal disorders symptoms', 'Blood samples', 'acceptance limits', 'safe and well tolerated', 'ratio of geometric means for C max', 'C max  and AUC 0-t  for mosapride']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0030304', 'cui_str': 'Pancreatin'}, {'cui': 'C1247955', 'cui_str': 'Simethicone Oral Tablet'}, {'cui': 'C0526501', 'cui_str': 'mosapride'}, {'cui': 'C0037138', 'cui_str': 'Simethicone'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C4517599', 'cui_str': '170'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0526501', 'cui_str': 'mosapride'}]",65.0,0.00789339,"The 90% confidence intervals for the ratio of geometric means for C max  (96.12%- 110.90%) and AUC 0-t  (99.07% - 108.06%) were within the defined acceptance limits of 75-133 and 80-125% for C max  and AUC 0-t  , respectively, indicating bioequivalence between the two products.","[{'ForeName': 'Karen Paola', 'Initials': 'KP', 'LastName': 'Camarillo Cárdenas', 'Affiliation': 'Clinical Pharmacology Department, Avant Santé Research Center S.A. de C.V. Nuevo León, San Pedro Garza García, Mexico.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'García González', 'Affiliation': 'Clinical Pharmacology Department, Avant Santé Research Center S.A. de C.V. Nuevo León, San Pedro Garza García, Mexico.'}, {'ForeName': 'Federico Alberto', 'Initials': 'FA', 'LastName': 'Argüelles Tello', 'Affiliation': 'Clinical Pharmacology Department, Avant Santé Research Center S.A. de C.V. Nuevo León, San Pedro Garza García, Mexico.'}, {'ForeName': 'Jorge Arturo', 'Initials': 'JA', 'LastName': 'Ocampo Ramírez', 'Affiliation': 'Established Pharmaceutical Division, Abbott Laboratories de México S.A. de C.V., Ciudad de México, Mexico.'}, {'ForeName': 'José Belisario', 'Initials': 'JB', 'LastName': 'Moreno Hernández', 'Affiliation': 'Established Pharmaceutical Division, Abbott Laboratories de México S.A. de C.V., Ciudad de México, Mexico.'}, {'ForeName': 'Murali Mohan', 'Initials': 'MM', 'LastName': 'Pendela', 'Affiliation': 'Clinical Pharmacology Department, Avant Santé Research Center S.A. de C.V. Nuevo León, San Pedro Garza García, Mexico.'}]",Fundamental & clinical pharmacology,['10.1111/fcp.12739']
1391,34844984,Comment on 'Direct swallowing training and oral sensorimotor stimulation in preterm infants: a randomised controlled trial' by Heo  et al .,,2022,,['preterm infants'],['Direct swallowing training and oral sensorimotor stimulation'],[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",[],,0.0974277,,"[{'ForeName': 'Celia M', 'Initials': 'CM', 'LastName': 'Harding', 'Affiliation': 'Department of Language and Communication Science, City, University of London, London, UK c.harding@city.ac.uk.'}, {'ForeName': 'Siew-Lian', 'Initials': 'SL', 'LastName': 'Crossley', 'Affiliation': ""Department of Speech-Language Pathology, Monash Children's Hospital, Clayton, New South Wales, Australia.""}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2021-323171']
1392,34844756,Survival analysis by inflammatory biomarkers in severely injured patients undergoing damage control resuscitation.,"BACKGROUND


Although early balanced blood product resuscitation has improved mortality after traumatic injury, many patients still suffer from inflammatory complications. The goal of this study was to identify inflammatory mediators associated with death and multiorgan system failure following severe injury after patients undergo blood product resuscitation.
METHODS


A retrospective secondary analysis of inflammatory markers from the Pragmatic Randomized Optimal Platelet and Plasma Ratios study was performed. Twenty-seven serum biomarkers were measured at 8 time points in the first 72 hours of care and were compared between survivors and nonsurvivors. Biomarkers with significant differences were further analyzed by adjudicated cause of 30-day mortality.
RESULTS


Biomarkers from 680 patients were analyzed. Seven key inflammatory markers (IL-1ra, IL-6, IL-8, IL-10, eotaxin, IP-10, and MCP-1) were further analyzed. These cytokines were also noted to have the highest hazard ratios of death. Stepwise selection was used for multivariate analysis of survival by time point. MCP-1 at 2 hours, eotaxin and IP-10 at 12 hours, eotaxin at 24 hours, and IP-10 at 72 hours were associated with all-cause mortality.
CONCLUSION


Early systemic inflammatory markers are associated with increased risk of mortality after traumatic injury. Future studies should use these biomarkers to prospectively calculate risks of morbidity and causes of mortality for all trauma patients.",2022,"Seven key inflammatory markers (IL-1ra, IL-6, IL-8, IL-10, eotaxin, IP-10, and MCP-1) were further analyzed.","['severe injury after patients undergo blood product resuscitation', '680 patients were analyzed', 'severely injured patients undergoing damage control resuscitation']",[],"['inflammatory markers (IL-1ra, IL-6, IL-8, IL-10, eotaxin, IP-10, and MCP-1', 'IP-10', '30-day mortality', 'highest hazard ratios of death']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0250604', 'cui_str': 'Eotaxin-1'}, {'cui': 'C1308752', 'cui_str': 'CXCL10 protein, human'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",680.0,0.291221,"Seven key inflammatory markers (IL-1ra, IL-6, IL-8, IL-10, eotaxin, IP-10, and MCP-1) were further analyzed.","[{'ForeName': 'Taylor E', 'Initials': 'TE', 'LastName': 'Wallen', 'Affiliation': 'Department of Surgery, University of Cincinnati, OH.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Hanseman', 'Affiliation': 'Department of Surgery, University of Cincinnati, OH.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Caldwell', 'Affiliation': 'Department of Surgery, University of Cincinnati, OH.'}, {'ForeName': 'Yao-Wei W', 'Initials': 'YW', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery, University of Texas Health Science Center at Houston, TX.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': 'Department of Surgery, University of Texas Health Science Center at Houston, TX.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': 'Department of Surgery, University of Alabama Birmingham, AL.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Pritts', 'Affiliation': 'Department of Surgery, University of Cincinnati, OH.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Goodman', 'Affiliation': 'Department of Surgery, University of Cincinnati, OH. Electronic address: michael.goodman@uc.edu.'}]",Surgery,['10.1016/j.surg.2021.08.060']
1393,34847780,Cost-effectiveness analysis of acupuncture compared with usual care for acute non-specific low back pain: secondary analysis of a randomised controlled trial.,"OBJECTIVE


To assess the cost-effectiveness of a single treatment session of acupuncture, when applied in addition to usual care for acute low back pain (ALBP).
METHODS


Secondary analysis of a multicentre randomised controlled trial in Norwegian general practice. In total, 171 participants with ALBP ⩽14 days were randomised to a control group (CG) receiving usual care or to an acupuncture group (AG) receiving one additional session of Western medical acupuncture alongside usual care. Primary outcome measures for this cost-effectiveness analysis were quality-adjusted life years (QALYs), health care costs and societal costs at days 28 and 365, the incremental cost-effectiveness ratio (ICER) and net monetary benefit (NMB). The NMB was calculated on the basis of the Norwegian cost-effectiveness threshold of NOK 275,000 (USD 35,628) per QALY gained. Missing data were replaced by multiple chained imputation.
RESULTS


Eighty-six participants in the CG and 81 in the AG were included in the analysis. We found no QALY gain at day 28. At day 365, the incremental QALY of 0.035 was statistically significant. The differences in health care costs and societal costs were not statistically significant. Three out of four calculations led to negative ICERs (cost saving) and positive NMBs. For the health care perspective at day 365, the ICER was USD -568 per QALY and the NMB was USD 1265, with 95.9% probability of acupuncture being cost-effective.
CONCLUSION


To our knowledge, this is the first cost-effectiveness analysis of acupuncture for ALBP. The findings indicate that acupuncture may be cost-effective from a 1-year perspective, but more studies are needed.
TRIAL REGISTRATION NUMBER


NCT01439412 (ClinicalTrials.gov).",2022,The differences in health care costs and societal costs were not statistically significant.,"['Norwegian general practice', 'acute low back pain (ALBP', '171 participants with ALBP ⩽14\u2009days', 'Eighty-six participants in the CG and 81 in the AG were included in the analysis', 'acute non-specific low back pain']","['acupuncture', 'usual care', 'control group (CG) receiving usual care or to an acupuncture group (AG) receiving one additional session of Western medical acupuncture alongside usual care']","['cost-effectiveness', 'cost-effectiveness analysis were quality-adjusted life years (QALYs), health care costs and societal costs at days 28 and 365, the incremental cost-effectiveness ratio (ICER) and net monetary benefit (NMB', 'health care costs and societal costs', 'negative ICERs (cost saving) and positive NMBs', 'QALY gain']","[{'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0457950', 'cui_str': 'Acute low back pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0068601', 'cui_str': 'neuromedin B'}]",171.0,0.177633,The differences in health care costs and societal costs were not statistically significant.,"[{'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Skonnord', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Fetveit', 'Affiliation': 'General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Holgeir', 'Initials': 'H', 'LastName': 'Skjeie', 'Affiliation': 'General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Brekke', 'Affiliation': 'General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Margreth', 'Initials': 'M', 'LastName': 'Grotle', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Atle', 'Initials': 'A', 'LastName': 'Klovning', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Aas', 'Affiliation': 'Department of Health Management and Health Economics, Institute of Health and Society, University of Oslo, Oslo, Norway.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/09645284211055747']
1394,34847750,All-cause mortality as the primary endpoint for the GRAIL/National Health Service England multi-cancer screening trial.,"A randomized trial of the GRAIL Galleri TM  multi-cancer screening test is being planned for the National Health Service in England, and will have 140,000 healthy participants aged 50-79: 70,000 exposed to screening and 70,000 unexposed. The test reportedly detects 50 different cancers and is expected to reduce all-cancer mortality by approximately 25%. Given this effect size-and that cancer deaths constitute a large fraction of all deaths-the trial is sufficiently large to test the effect on all-cause mortality. Because most patients believe cancer screening ""saves lives"", the GRAIL/National Health Service collaboration could set the evaluation standard for multi-cancer screening.",2022,"A randomized trial of the GRAIL Galleri TM  multi-cancer screening test is being planned for the National Health Service in England, and will have 140,000 healthy participants aged 50-79: 70,000 exposed to screening and 70,000 unexposed.","['140,000 healthy participants aged 50-79: 70,000 exposed to screening and 70,000 unexposed']",['GRAIL Galleri TM  multi-cancer screening test'],['cancer mortality'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C2717746', 'cui_str': 'Cancer Screening Tests'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",140000.0,0.313496,"A randomized trial of the GRAIL Galleri TM  multi-cancer screening test is being planned for the National Health Service in England, and will have 140,000 healthy participants aged 50-79: 70,000 exposed to screening and 70,000 unexposed.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carr', 'Affiliation': 'Department of Pathology, Detroit Medical Center University Labs, Wayne State University School of Medicine, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kent', 'Affiliation': 'Predictive Analytics and Comparative Effectiveness (PACE) Center, Tufts Clinical and Translational Science Institute, Tufts Medical Center, USA.'}, {'ForeName': 'H Gilbert', 'Initials': 'HG', 'LastName': 'Welch', 'Affiliation': ""Center for Surgery and Public Health, 1861Brigham and Women's Hospital, USA.""}]",Journal of medical screening,['10.1177/09691413211059638']
1395,34794236,Target engagement of the first-in-class CXCR7 antagonist ACT-1004-1239 following multiple-dose administration in mice and humans.,"Antagonism of the chemokine receptor CXCR7 has shown promising effects in diverse disease areas through modulation of its ligands, CXCL11 and CXCL12. Preclinical data of the first-in-class CXCR7 antagonist, ACT-1004-1239, showed efficacy in animal models of multiple sclerosis and acute lung injury. In healthy humans, single-dose administration of ACT-1004-1239 revealed a favorable clinical profile. Here, we report the target engagement of ACT-1004-1239 in healthy mice and humans after multiple doses using CXCL11 and CXCL12 as biomarkers. In addition, safety/tolerability, concentration-QTc relationship, and pharmacokinetics (PK) were assessed in a randomized, double-blind, placebo-controlled Phase 1 clinical study. Multiple-dose ACT-1004-1239 dose-dependently increased CXCL12 plasma concentration across the investigated dose range in mice and humans (mice: 1-100 mg/kg b.i.d.; humans: 30-200 mg o.d.) when compared to vehicle/placebo demonstrating target engagement. Mouse and human PK/PD models predicted that CXCL12 concentration approached a plateau within these dose ranges. In humans, ACT-1004-1239 was rapidly absorbed (t max : 1.75-3.01 h) and the terminal t 1/2  was approximately 19 h. Steady-state conditions were reached by Day 3 with an accumulation index of 1.2. Female subjects had overall higher exposure compared to males. Multiple-dose ACT-1004-1239 was well tolerated up to 200 mg once daily in humans. There was no evidence of ACT-1004-1239-mediated QTc interval prolongation. Overall, multiple oral doses of ACT-1004-1239 showed target engagement with CXCR7 in healthy mice and humans, therefore, assessment of CXCL12 as translational tool for further investigations in patients is warranted. Favorable safety/tolerability and PK profiles allow for further clinical development.",2021,"Antagonism of the chemokine receptor CXCR7 has shown promising effects in diverse disease areas through modulation of its ligands, CXCL11 and CXCL12.",['mice and humans'],['placebo'],"['CXCL12 concentration', 'safety/tolerability, concentration-QTc relationship, and pharmacokinetics (PK', 'CXCL12 plasma concentration']","[{'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0218504', 'cui_str': 'CXCL12 Chemokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.233836,"Antagonism of the chemokine receptor CXCR7 has shown promising effects in diverse disease areas through modulation of its ligands, CXCL11 and CXCL12.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Huynh', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Department of Clinical Pharmacology, 4123 Allschwil, Switzerland; Biopharmacy, Department of Pharmaceutical Sciences, University of Basel, 4056 Basel, Switzerland. Electronic address: christine.huynh@idorsia.com.'}, {'ForeName': 'Janneke M', 'Initials': 'JM', 'LastName': 'Brussee', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Department of Clinical Pharmacology, 4123 Allschwil, Switzerland.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Pouzol', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Department of Pharmacology Immunology, 4123 Allschwil, Switzerland.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Fonseca', 'Affiliation': 'BlueClinical Phase 1, Hospital de Prelada, 4250-449 Porto, Portugal.'}, {'ForeName': 'Henriette E', 'Initials': 'HE', 'LastName': 'Meyer Zu Schwabedissen', 'Affiliation': 'Biopharmacy, Department of Pharmaceutical Sciences, University of Basel, 4056 Basel, Switzerland.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Department of Clinical Pharmacology, 4123 Allschwil, Switzerland.'}, {'ForeName': 'Patricia N', 'Initials': 'PN', 'LastName': 'Sidharta', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Department of Clinical Pharmacology, 4123 Allschwil, Switzerland.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2021.112363']
1396,34909972,Oral dydrogesterone in frozen-thawed embryo transfer cycles.,"OBJECTIVE


The aim of this study was to compare the use of micronized vaginal progesterone and oral dydrogesterone in the endometrial preparation for frozen-thawed embryo transfer.
METHODS


This was a randomized, controlled, open, two-armed clinical trial, with women undergoing frozen-thawed embryo transfer along with hormone replacement therapy for endometrial preparation, between September 2019 and February 2021. A total of 73 patients were randomly selected and orally administered 40 mg/day dydrogesterone (dydrogesterone group, n=36) or 800 mg/day micronized vaginal progesterone (micronized vaginal progesterone group, n=37), after endometrial preparation with transdermal estradiol. The main outcome was a viable ongoing pregnancy with 12 weeks of gestation as evaluated by ultrasound.
RESULTS


The reproductive outcomes in frozen-thawed embryo transfer cycles were similar, with pregnancy rates in the dydrogesterone and micronized vaginal progesterone treatment groups being, respectively, 33.3 and 32.4% at 12 weeks pregnancy (confidence interval= -22.4-20.6, p=0.196).
CONCLUSIONS


The use of oral dydrogesterone may be a more patient-friendly approach to endometrial preparation in frozen-thawed embryo transfer cycles, avoiding undesirable side effects and discomfort resulting from vaginal administration, while also providing similar reproductive results.",2022,"The reproductive outcomes in frozen-thawed embryo transfer cycles were similar, with pregnancy rates in the dydrogesterone and micronized vaginal progesterone treatment groups being, respectively, 33.3 and 32.4% at 12 weeks pregnancy (confidence","['73 patients', 'women undergoing frozen-thawed embryo transfer along with hormone replacement therapy for endometrial preparation, between September 2019 and February 2021']","['dydrogesterone', 'Oral dydrogesterone', 'micronized vaginal progesterone (micronized vaginal progesterone', 'endometrial preparation with transdermal estradiol', 'micronized vaginal progesterone', 'dydrogesterone (dydrogesterone', 'micronized vaginal progesterone and oral dydrogesterone']","['reproductive outcomes in frozen-thawed embryo transfer cycles', 'viable ongoing pregnancy with 12 weeks of gestation as evaluated by ultrasound', 'pregnancy rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}]","[{'cui': 'C0013340', 'cui_str': 'Dydrogesterone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}]","[{'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",73.0,0.0193657,"The reproductive outcomes in frozen-thawed embryo transfer cycles were similar, with pregnancy rates in the dydrogesterone and micronized vaginal progesterone treatment groups being, respectively, 33.3 and 32.4% at 12 weeks pregnancy (confidence","[{'ForeName': 'Luma Caroline Gomes Mattos de', 'Initials': 'LCGM', 'LastName': 'Macedo', 'Affiliation': 'Irmandade da Santa Casa de Misericórdia de São Paulo, School of Medical Sciences, Department of Obstetrics and Gynecology - São Paulo (SP), Brazil.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cavagna Neto', 'Affiliation': 'Centro de Referência da Saúde da Mulher Hospital Pérola Byington, Human Reproduction - São Paulo (SP), Brazil.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Dzik', 'Affiliation': 'Centro de Referência da Saúde da Mulher Hospital Pérola Byington, Human Reproduction - São Paulo (SP), Brazil.'}, {'ForeName': 'Andressa do Rosário', 'Initials': 'ADR', 'LastName': 'Rocha', 'Affiliation': 'Centro de Referência da Saúde da Mulher Hospital Pérola Byington, Human Reproduction - São Paulo (SP), Brazil.'}, {'ForeName': 'Sônia Maria Rolim Rosa', 'Initials': 'SMRR', 'LastName': 'Lima', 'Affiliation': 'Irmandade da Santa Casa de Misericórdia de São Paulo, School of Medical Sciences, Department of Obstetrics and Gynecology - São Paulo (SP), Brazil.'}]",Revista da Associacao Medica Brasileira (1992),['10.1590/1806-9282.20210874']
1397,34910093,Effect of 3 Forms of Early Intervention for Young People With Borderline Personality Disorder: The MOBY Randomized Clinical Trial.,"Importance


Clinical trials have neither focused on early intervention for psychosocial impairment nor on the contribution of components of borderline personality disorder (BPD) treatment beyond individual psychotherapy.
Objective


To evaluate the effectiveness of 3 early interventions for BPD of differing complexity.
Design, Settings, and Participants


This single-blinded randomized clinical trial recruited young people between March 17, 2011, and September 30, 2015, into parallel groups. The study took place at 2 government-funded mental health services for young people in Melbourne, Australia. Inclusion criteria were age 15 to 25 years (inclusive), recent DSM-IV-TR BPD diagnosis, and never receiving evidence-based BPD treatment. A total of 139 participants were randomized (pool of 876; 70 declined, 667 excluded), balanced for sex, age, and depressive symptomatology. Data analysis completed May 2020.
Interventions


(1) The Helping Young People Early (HYPE) dedicated BPD service model for young people, combined with weekly cognitive analytic therapy (CAT); (2) HYPE combined with a weekly befriending psychotherapy control condition; and (3) a general youth mental health service (YMHS) model, combined with befriending. Therefore, the 3 treatment arms were HYPE + CAT, HYPE + befriending, and YMHS + befriending. Participants were randomly assigned both to 1 treatment arm (in a 1:1:1 ratio) and to a clinician.
Main Outcomes and Measures


Psychosocial functioning, measured with the Inventory of Interpersonal Problems Circumplex Version and the Social Adjustment Scale Self-report.
Results


One hundred twenty-eight participants (104 [81.3%] were female; mean [SD] age, 19.1 [2.8] years; HYPE + CAT: 40 [31.3%]; HYPE + befriending: 45 [35.2%]; YMHS + befriending: 43 [33.6%]) who provided postbaseline data were included in the intent-to-treat analysis. Regardless of group, from baseline to 12 months, there was a mean of 19.3% to 23.8% improvement in the primary outcomes and 40.7% to 52.7% for all secondary outcomes, except severity of substance use and client satisfaction. The latter remained high across all time points. Planned comparisons (YMHS + befriending vs HYPE; HYPE + CAT vs befriending) showed that neither the service model nor the psychotherapy intervention was associated with a superior rate of change in psychosocial functioning by the 12-month primary end point. The HYPE service model was superior to YMHS + befriending for treatment attendance (median [IQR], 22 [19] vs 3 [16] contacts; median duration, 200 [139.5] vs 94 [125] days) and treatment completion (44 of 92 [47.8%] vs 9 of 47 [19.2%]). HYPE + CAT was superior to befriending for treatment attendance (median [IQR], 12 [16.5] vs 3 [9.8] sessions) and treatment completion (24 of 46 [52.2%] vs 29 of 93 [31.2%]).
Conclusions and Relevance


In this randomized clinical trial of 3 interventions for young people with BPD, effective early intervention was not reliant on availability of specialist psychotherapy but did require youth-oriented clinical case management and psychiatric care. A dedicated early intervention BPD service model (HYPE), with or without individual psychotherapy, achieved greater treatment attendance and completion, making it more likely to meet service user, family, and community expectations of care.
Trial Registration


anzctr.org.au Identifier: ACTRN12610000100099.",2022,"A dedicated early intervention BPD service model (HYPE), with or without individual psychotherapy, achieved greater treatment attendance and completion, making it more likely to meet service user, family, and community expectations of care.
","['mean [SD] age, 19.1 [2.8] years', 'young people between March 17, 2011, and September 30, 2015, into parallel groups', 'young people with BPD, effective early intervention was not reliant on availability of specialist psychotherapy but did require youth-oriented clinical case management and psychiatric care', 'Young People With Borderline Personality Disorder', 'young people in Melbourne, Australia', 'One hundred twenty-eight participants (104 [81.3', '139 participants were randomized (pool of 876; 70 declined, 667 excluded), balanced for sex, age, and depressive symptomatology', 'Inclusion criteria were age 15 to 25 years (inclusive), recent DSM-IV-TR BPD diagnosis, and never receiving evidence-based BPD treatment']","['Planned comparisons (YMHS\u2009+\u2009befriending vs HYPE; HYPE\u2009+\u2009CAT vs befriending', 'cognitive analytic therapy (CAT); (2) HYPE combined with a weekly befriending psychotherapy control condition; and (3) a general youth mental health service (YMHS) model, combined with befriending', 'HYPE\u2009+\u2009CAT', 'Early Intervention', 'dedicated early intervention BPD service model (HYPE), with or without individual psychotherapy']","['Measures\n\n\nPsychosocial functioning, measured with the Inventory of Interpersonal Problems Circumplex Version and the Social Adjustment Scale Self-report', 'severity of substance use and client satisfaction', 'superior rate of change in psychosocial functioning']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0204523', 'cui_str': 'Psychiatric therapeutic procedure'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C4517851', 'cui_str': '667'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1272257', 'cui_str': 'Cognitive analytic therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0204525', 'cui_str': 'Individual psychotherapy'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451487', 'cui_str': 'Social adjustment scale self - report'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",139.0,0.187605,"A dedicated early intervention BPD service model (HYPE), with or without individual psychotherapy, achieved greater treatment attendance and completion, making it more likely to meet service user, family, and community expectations of care.
","[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Chanen', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Betts', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Jackson', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Cotton', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gleeson', 'Affiliation': 'Healthy Brain and Mind Research Centre and School of Behavioural and Health Sciences, Australian Catholic University, Melbourne Campus, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Davey', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Thompson', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sharnel', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Rayner', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Andrewes', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'McCutcheon', 'Affiliation': 'Orygen, Melbourne, Victoria, Australia.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2021.3637']
1398,34820724,The effects of connective tissue graft position on clinical and aesthetical outcomes of gingival recession treatment: a controlled randomized clinical trial.,"OBJECTIVES


This randomized controlled clinical trial with 1-year follow-up compared the clinical and aesthetic results of coronally advanced flap (CAF) + connective tissue graft (CTG) positioned apical to the cemento-enamel junction (CEJ) (CAF + CTG-ACEJ) with CAF + CTG positioned on the CEJ (CAF + CTG-CEJ) for treating isolated gingival recession defects.
MATERIALS AND METHODS


Thirty-eight patients with recession type 1 (RT 1) with a depth ≥ 3, gingival recessions were enrolled. Nineteen patients were randomly assigned to the CAF + CTG-ACEJ group or CAF + CTG-CEJ group. Clinical and aesthetical evaluations were made at 6 and 12 months.
RESULTS


While the 6 months results showed that both surgical techniques were similar for clinical outcomes, the results achieved at the 6th month were more stable in the CAF + CTG-ACEJ group at the 12th month with significantly better recession depth, mean, and complete root coverage values and aesthetical results.
CONCLUSIONS


Isolated gingival recession defects can be clinically successfully treated by both CAF + CTG-ACEJ and CAF + CTG-CEJ techniques.
CLINICAL RELEVANCE


Limited studies have compared the clinical and aesthetical effects of positioning CTG apical to the CEJ for the treatment of gingival recessions. This randomized clinical study showed that CAF + CTG-ACEJ technique can provide additional benefit for the treatment. The described technique is effective in obtaining better long-term CRC stability and aesthetics.",2022,"While the 6 months results showed that both surgical techniques were similar for clinical outcomes, the results achieved at the 6th month were more stable in the CAF + CTG-ACEJ group at the 12th month with significantly better recession depth, mean, and complete root coverage values and aesthetical results.
","['Nineteen patients', 'gingival recession treatment', 'Thirty-eight patients with recession type 1 (RT 1) with a depth\u2009≥\u20093, gingival recessions were enrolled']","['CEJ (CAF\u2009+\u2009CTG-CEJ', 'CAF\u2009+\u2009CTG-ACEJ group or CAF\u2009+\u2009CTG-CEJ', 'connective tissue graft position', 'CAF\u2009+\u2009CTG-ACEJ technique', 'coronally advanced flap (CAF)\u2009+\u2009connective tissue graft (CTG']",[],"[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],38.0,0.0656596,"While the 6 months results showed that both surgical techniques were similar for clinical outcomes, the results achieved at the 6th month were more stable in the CAF + CTG-ACEJ group at the 12th month with significantly better recession depth, mean, and complete root coverage values and aesthetical results.
","[{'ForeName': 'Onur Ucak', 'Initials': 'OU', 'LastName': 'Turer', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Ozcan', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Cukurova University, Adana, Turkey. mustafaozcan@cu.edu.tr.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Alkaya', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Gulsah', 'Initials': 'G', 'LastName': 'Seydaoglu', 'Affiliation': 'Department of Biostatistics, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'SelenYildiz', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Mehmet Cenk', 'Initials': 'MC', 'LastName': 'Haytac', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Cukurova University, Adana, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-021-04250-7']
1399,34822113,"Time to Onset of Response to Pitolisant for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients With Narcolepsy: An Analysis of Randomized, Placebo-Controlled Trials.","BACKGROUND


Pitolisant is approved in the USA and Europe for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy.
OBJECTIVE


Analyses evaluated the time to onset of clinical response during treatment with pitolisant.
METHODS


Data were obtained from two randomized, double-blind, 7-week or 8-week, placebo-controlled studies (HARMONY 1, HARMONY CTP). Study medication was individually titrated to a maximum dose of pitolisant 35.6 mg/day and then remained stable. Efficacy assessments included the Epworth Sleepiness Scale and weekly rate of cataplexy (calculated from patient diaries). Onset of clinical response was defined as the first timepoint at which there was statistical separation between pitolisant and placebo.
RESULTS


The analysis included 61 patients in HARMONY 1 (pitolisant, n = 31; placebo, n = 30) and 105 patients in HARMONY CTP (pitolisant, n = 54; placebo, n = 51). Onset of clinical response began at week 2 (HARMONY 1) or week 3 (HARMONY CTP) for the mean change in Epworth Sleepiness Scale score, and week 2 (HARMONY CTP) or week 5 (HARMONY 1) for the mean change in weekly rate of cataplexy, with further improvements observed in pitolisant-treated patients through the end of treatment. The percentage of treatment responders was significantly greater with pitolisant vs placebo beginning at week 3 for excessive daytime sleepiness (defined as an Epworth Sleepiness Scale score reduction ≥ 3) and week 2 for cataplexy (defined as a ≥ 50% reduction in weekly rate of cataplexy [HARMONY CTP]).
CONCLUSIONS


Onset of clinical response for excessive daytime sleepiness and/or cataplexy was generally observed within the first 2-3 weeks of pitolisant treatment in patients with narcolepsy. CLINICALTRIALS.
GOV IDENTIFIER


NCT01067222 (February 2010), NCT01800045 (February 2013).",2021,"The percentage of treatment responders was significantly greater with pitolisant vs placebo beginning at week 3 for excessive daytime sleepiness (defined as an Epworth Sleepiness Scale score reduction ≥ 3) and week 2 for cataplexy (defined as a ≥ 50% reduction in weekly rate of cataplexy [HARMONY CTP]).
","['adults with narcolepsy', 'patients with narcolepsy', 'Patients With Narcolepsy', '61 patients in HARMONY 1 (pitolisant, n = 31; placebo, n = 30) and 105 patients in HARMONY CTP (pitolisant, n = 54; placebo, n = 51']","['Placebo', 'placebo']","['percentage of treatment responders', 'Epworth Sleepiness Scale score', 'Epworth Sleepiness Scale and weekly rate of cataplexy (calculated from patient diaries', 'excessive daytime sleepiness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3529928', 'cui_str': 'pitolisant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0010734', 'cui_str': 'Cytidine triphosphate'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4706348', 'cui_str': 'ESS (Epworth Sleepiness Scale) score'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0007384', 'cui_str': 'Cataplexy'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}]",,0.243147,"The percentage of treatment responders was significantly greater with pitolisant vs placebo beginning at week 3 for excessive daytime sleepiness (defined as an Epworth Sleepiness Scale score reduction ≥ 3) and week 2 for cataplexy (defined as a ≥ 50% reduction in weekly rate of cataplexy [HARMONY CTP]).
","[{'ForeName': 'Nathaniel F', 'Initials': 'NF', 'LastName': 'Watson', 'Affiliation': 'Department of Neurology, University of Washington School of Medicine, Seattle, WA, USA. nwatson@uw.edu.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Davis', 'Affiliation': 'Harmony Biosciences, LLC, Plymouth Meeting, PA, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Zarycranski', 'Affiliation': 'Harmony Biosciences, LLC, Plymouth Meeting, PA, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Vaughn', 'Affiliation': 'Rho, Durham, NC, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Dayno', 'Affiliation': 'Harmony Biosciences, LLC, Plymouth Meeting, PA, USA.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'National Reference Center for Narcolepsy, Montpellier, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Schwartz', 'Affiliation': 'Bioprojet Pharma, Paris, France.'}]",CNS drugs,['10.1007/s40263-021-00866-1']
1400,34838980,"Sarcojoint®, the branched-chain amino acid-based supplement, plus resistance exercise improved muscle mass in adults aged 50 years and older: A double-blinded randomized controlled trial.","Functional ability and intrinsic capacity are key elements of healthy aging, in which exercise and good nutrition play important roles. This 12-week double-blinded randomized controlled trial enrolled community-dwelling adults aged 50 years and older to examine the effects of Sarcojoint®, a comprehensive formula for the musculoskeletal system, plus resistance exercise on muscle mass. This study intended to enroll 80 participants with a randomly selected subsample of 32 participants (16 from the intervention group and 16 from controls) for magnetic resonance imaging (MRI) to assess the cross-sectional area of the bilateral mid-thighs. The participants were then randomly assigned to the intervention group (Sarcojoint® 1 package twice a day) and control group (vitamin B as placebo) at a 1: 1 ratio. All the participants were required to undergo a regular exercise program (45 min at the gym per week and two sessions of 30-min exercise at home). The data from 66 participants (68.1 ± 7.1 years and 16.7% males; intervention group: 32, control group: 34) were available for analysis. The whole study was pre-registered and data reporting followed Consolidated Standards of Reporting Trials with the primary endpoints of muscle mass, 30-s chair-rise test, and gait speed. Results of MRI were the subgroup analysis to examine muscle mass and intramuscular adiposity. The baseline characteristics of all the participants between groups were similar, as well as those of the MRI subgroups. Within-group comparisons showed that the intervention group, but not the control group, significantly reduced the total body fat percentage (34.3 ± 5.5 vs. 35.0 ± 5.4%, P = 0.021). Serum vitamin D was increased in the intervention group (24.1 ± 6.1 vs. 21.1 ± 7.0 ng/mL; P = 0.025) and was reduced in the control group (18.0 ± 5.2 vs. 20.2 ± 5.8 ng/mL; P = 0.006). The physical performance tests of both groups were significantly improved. The between-group analysis showed no significant differences in 30-s chair stand test, handgrip strength and appendicular muscle mass. The sub-group analysis showed significant improvement in the serum levels of vitamin D (6.70 ± 8.20 vs. -0.50 ± 3.90 ng/mL; P = 0.001) and the mid-thigh cross-sectional area of the nondominant legs (165.4 ± 291.4 vs. -61.1 ± 195.0 mm 2 ; P = 0.034) in the intervention group. In conclusion, Sarcojoint® plus resistance exercise significantly increased muscle mass and serum levels of vitamin D, but not significantly better in muscle strength and physical performance than controls. More investigations are needed to evaluate the long-term effects of Sarcojoint® on middle-aged and older adults.",2022,"The between-group analysis showed no significant differences in 30-s chair stand test, handgrip strength and appendicular muscle mass.","['middle-aged and older adults', 'adults aged 50\u202fyears and older', '66 participants (68.1\u202f±\u202f7.1\u202fyears and 16.7% males; intervention group: 32, control group: 34) were available for analysis', 'enrolled community-dwelling adults aged 50\u202fyears and older', '80 participants with a randomly selected subsample of 32 participants (16 from the intervention group and 16 from controls) for']","['intervention group (Sarcojoint® 1 package twice a day) and control group (vitamin B as placebo', 'Sarcojoint®, a comprehensive formula for the musculoskeletal system, plus resistance exercise', 'regular exercise program', 'Sarcojoint®, the branched-chain amino acid-based supplement, plus resistance exercise', 'Sarcojoint®', 'magnetic resonance imaging (MRI']","['total body fat percentage', '30-s chair stand test, handgrip strength and appendicular muscle mass', 'Serum vitamin D', 'muscle strength and physical performance', 'physical performance tests', 'serum levels of vitamin D', 'muscle mass and serum levels of vitamin D']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026860', 'cui_str': 'Musculoskeletal system subdivision'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",80.0,0.22147,"The between-group analysis showed no significant differences in 30-s chair stand test, handgrip strength and appendicular muscle mass.","[{'ForeName': 'Li-Ning', 'Initials': 'LN', 'LastName': 'Peng', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan; Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chin', 'Initials': 'PC', 'LastName': 'Yu', 'Affiliation': 'Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Neuroscience, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Chia-Chia', 'Initials': 'CC', 'LastName': 'Hsu', 'Affiliation': 'Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Hospital and Health Care Administration, National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'Sung-Hua', 'Initials': 'SH', 'LastName': 'Tseng', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan; Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Ju', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan; Department of Family Medicine, Taipei Veterans General Hospital Yuanshan Branch, Yi-Land, Taiwan.'}, {'ForeName': 'Ming-Hsien', 'Initials': 'MH', 'LastName': 'Lin', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan; Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Fei-Yuan', 'Initials': 'FY', 'LastName': 'Hsiao', 'Affiliation': 'Graduate Institute of Clinical Pharmacy, National Taiwan University, Taipei, Taiwan; School of Pharmacy, National Taiwan University, Taipei, Taiwan; Department of Pharmacy, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Liang-Kung', 'Initials': 'LK', 'LastName': 'Chen', 'Affiliation': 'Aging and Health Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan; Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan; Taipei Municipal Gan-Dau Hospital (Managed by Taipei Veterans General Hospital), Taipei, Taiwan. Electronic address: lkchen2@vghtpe.gov.tw.'}]",Experimental gerontology,['10.1016/j.exger.2021.111644']
1401,34842281,Testing the impact of an online mindfulness program on prelicensure nursing students stress and anxiety.,"BACKGROUND


Fourth-year nursing students are under stress due to internal, external, and situational stressors.
PURPOSE


The purpose of this study was to evaluate the impact of an online mindfulness intervention on fourth-year nursing students' depression, anxiety, stress, and coping.
METHODS


Lazarus and Folkman's Transactional Model of Stress and Coping was used to guide the proposed intervention using a quasi-experimental pretest-posttest one-group design. Students took the pretest at the start of the semester, 2 weeks later they started the intervention for 4 weeks. The posttest was administered 2 weeks after completion of the intervention.
RESULTS


Nursing students who completed the 4-week online mindfulness intervention reported decreased anxiety and stress. Open-ended questions revealed the intervention was beneficial, and the time spent practicing mindfulness was valuable.
CONCLUSION


The online mindfulness intervention resulted in lowered anxiety and stress in nursing students' engaged in clinical courses and warrants further study.",2022,The online mindfulness intervention resulted in lowered anxiety and stress in nursing students' engaged in clinical courses and warrants further study.,"['Nursing students', 'prelicensure nursing students stress and anxiety']","['online mindfulness program', 'online mindfulness intervention']",['anxiety and stress'],"[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.0212522,The online mindfulness intervention resulted in lowered anxiety and stress in nursing students' engaged in clinical courses and warrants further study.,"[{'ForeName': 'Hollis', 'Initials': 'H', 'LastName': 'Franco', 'Affiliation': 'Traditional Undergraduate Program, Texas Tech University Health Sciences Center, School of Nursing, Lubbock, Texas, USA.'}]",Nursing forum,['10.1111/nuf.12679']
1402,34997825,Phase I Study of the Pharmacodynamics and Safety of Sodium Zirconium Cyclosilicate in Healthy Chinese Adults.,"Sodium zirconium cyclosilicate (SZC) is an effective potassium binder for patients with hyperkalemia. This single-center, open-label, phase I study (NCT03283267) characterized the pharmacodynamics and safety of SZC in Chinese individuals. Twenty-two healthy Chinese adults (mean age, 33.5 years) randomized 1:1 received daily oral SZC 5 or 10 g for 4 days, following 4 days on a low-sodium, high-potassium diet (continued throughout the study). End points were mean change from baseline in 24-hour urinary potassium (primary) and sodium excretion, and serum potassium concentration. Urinary potassium excretion significantly decreased with SZC 5 g (mean change [mmol], -13.0; P < .001) and 10 g (-15.4; P < .001). Although urinary sodium excretion decreased significantly with SZC 5 g (-11.5; P = .030), there was no significant change with SZC 10 g (-5.1; P = .299). Serum potassium concentrations decreased significantly with SZC 5 g (-0.14; P = .031) and 10 g (-0.20; P = .002). All treatment-emergent adverse events were mild, and none were considered causally related to SZC. Over 4 days, the pharmacodynamics and safety of SZC were consistent in healthy Chinese adults with global studies and patients of Japanese ethnicity.",2022,"Although urinary sodium excretion decreased significantly with SZC 5 g (-11.5; P = .030), there was no significant change with SZC ","['healthy Chinese adults with global studies and patients of Japanese ethnicity', 'Chinese individuals', 'Healthy Chinese Adults', 'Twenty-two healthy Chinese adults (mean age, 33.5 years', 'patients with hyperkalemia']","['SZC', 'low-sodium, high-potassium diet', 'daily oral SZC', 'Sodium Zirconium Cyclosilicate', 'Sodium zirconium cyclosilicate (SZC']","['Serum potassium concentrations', 'Urinary potassium excretion', '24-hour urinary potassium (primary) and sodium excretion, and serum potassium concentration', 'urinary sodium excretion']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}]","[{'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0452341', 'cui_str': 'Increased potassium diet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}]",22.0,0.0350266,"Although urinary sodium excretion decreased significantly with SZC 5 g (-11.5; P = .030), there was no significant change with SZC ","[{'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Hong Kong, HKSAR, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'AstraZeneca, Shanghai, China.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'AstraZeneca, Wilmington, Delaware, USA.'}, {'ForeName': 'Yulin', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Formerly AstraZeneca R&D China, Shanghai, China.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Någård', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, AstraZeneca R&D, Gaithersburg, Maryland, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.1055']
1403,34843839,Intranasal oxytocin administration improves mood in new mothers with moderate low mood but not in mothers with elevated symptoms of postnatal depression: A randomised controlled trial.,"BACKGROUND


Oxytocin (OT) is a neuropeptide hormone that has anxiolytic and antidepressant effects, and positive effects on social affiliation and behaviour, particularly in parenting and attachment relationships. In women with postnatal depression (PND), each of these are reduced. This study investigated if OT administration reduces low mood in new mothers with PND and across the low mood spectrum.
DESIGN


A double-blind, placebo-controlled, randomised controlled-trial, within-subjects, cross-over design was conducted.
PARTICIPANTS


Mothers (N = 58) between 3 and 9 months postpartum. Participants were screened for traits of PND on the Edinburgh Postnatal Depression Scale (EPDS) and assigned into 2 groups: probable PND cases (N = 26, scoring ≥9) and controls (N = 32, scoring ≤9).
METHOD


Participants rated their current mood on the Positive and Negative Affect Scale (PANAS) at Baseline (before nasal administration), Condition 1 (after first OT/Placebo administration) and Condition 2 (after second OT/Placebo administration).
RESULTS


OT administration did not affect mood in women with PND scores above the cut-off point but significantly reduced negative mood in those scoring below the cut-off point. To explore if a subgroup was driving this, we compared participants with mild, moderate and severe scores on the EPDS. OT administration significantly reduced negative mood in women with moderate low mood scores on the EPDS.
LIMITATIONS


PND was assessed by the EPDS, rather than a clinical diagnosis.
CONCLUSION


These results illustrate individual differences in response to OT administration and suggest that OT administration may offer treatment benefit to new mothers who report moderate sub-clinical levels of depression.",2022,"RESULTS


OT administration did not affect mood in women with PND scores above the cut-off point but significantly reduced negative mood in those scoring below the cut-off point.","['Participants rated their current mood on the Positive and Negative Affect Scale (PANAS) at Baseline (before nasal administration), Condition 1 (after first OT/Placebo administration) and Condition 2 (after second OT/Placebo administration', 'women with postnatal depression (PND', 'new mothers with PND and across the low mood spectrum', 'participants with mild, moderate and severe scores on the EPDS', 'Participants were screened for traits of PND on the Edinburgh Postnatal Depression Scale (EPDS) and assigned into 2 groups: probable PND cases (N\u202f=\u202f26, scoring ≥9) and controls (N\u202f=\u202f32, scoring ≤9', 'new mothers with moderate low mood but not in mothers with elevated symptoms of postnatal depression', 'Mothers (N\u202f=\u202f58) between 3-9 months postpartum']","['Intranasal oxytocin', 'Oxytocin (OT', 'placebo', 'OT']",['PND scores'],"[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0001560', 'cui_str': 'Medication administration: nasal'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",58.0,0.180129,"RESULTS


OT administration did not affect mood in women with PND scores above the cut-off point but significantly reduced negative mood in those scoring below the cut-off point.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Lindley Baron-Cohen', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, United Kingdom; The Anna Freud National Centre for Children and Families, United Kingdom. Electronic address: k.lindleybaron-cohen.10@ucl.ac.uk.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Feldman', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Israel.'}, {'ForeName': 'Pasco', 'Initials': 'P', 'LastName': 'Fearon', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, United Kingdom; The Anna Freud National Centre for Children and Families, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, United Kingdom; The Anna Freud National Centre for Children and Families, United Kingdom.'}]",Journal of affective disorders,['10.1016/j.jad.2021.11.062']
1404,34844841,The healing potential of Draksha-guduchyadi kavala in radiotherapy induced oral mucositis in non-metastatic squamous cell carcinoma of head and neck: A comparative case study.,"Patients undergoing Radiotherapy (RT) for Head and Neck carcinoma often suffer from side effects such as mucositis, xerostomia, pharyngitis, laryngitis and pain which are being managed symptomatically by mouthwashes of soda-salt, chlorhexidine or betadine. Among the side effects, oral mucositis is the most debilitating one. This comparative case study comprises of 4 patients undergoing RT. Here, 2 patients each are randomly allocated into two groups. One group received the existing prophylactic management i.e., Sodium bicarbonate-salt solution mouth wash and the other group received, Draksha-guduchyadi yoga for kavala (gargling). Both the sets of patients were asked to perform gargling, from the first day of radiation to 15 days thereafter. The effectiveness of both mouthwashes was compared for their healing potential on oral mucositis by RTOG grading. The reduction in mucositis was significant in the group which received Ayurvedic mouthwash compared to the other group. This study positively highlights the contribution of Ayurveda in cancer treatment especially in the field of quality of life.",2021,The reduction in mucositis was significant in the group which received Ayurvedic mouthwash compared to the other group.,"['4 patients undergoing RT', 'Patients undergoing', 'non-metastatic squamous cell carcinoma of head and neck']","['radiotherapy', 'existing prophylactic management i.e., Sodium bicarbonate-salt solution mouth wash and the other group received, Draksha-guduchyadi yoga for kavala (gargling', 'Radiotherapy (RT', 'chlorhexidine or betadine']","['reduction in mucositis', 'oral mucositis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C3653289', 'cui_str': 'Salt solutions'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0699524', 'cui_str': 'Betadine'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]",4.0,0.0198781,The reduction in mucositis was significant in the group which received Ayurvedic mouthwash compared to the other group.,"[{'ForeName': 'Saniya', 'Initials': 'S', 'LastName': 'C K', 'Affiliation': 'Department of Kayachikitsa, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India. Electronic address: saniyack@gmail.com.'}, {'ForeName': 'Mangalagowri V', 'Initials': 'MV', 'LastName': 'Rao', 'Affiliation': 'Department of Swasthavritta Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Choudhary', 'Affiliation': 'Department of Radiotherapy & Radiation Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Om Prakash', 'Initials': 'OP', 'LastName': 'Singh', 'Affiliation': 'Department of Kayachikitsa, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2021.09.002']
1405,34845800,The aversive value of pain in human decision-making.,"BACKGROUND


In order to decide between avoiding pain or pursuing competing rewards, pain must be assigned an abstract value that can be traded against that of competing goods. To assess the relationship between subjectively perceived pain and its value, we conducted an experiment where participants had to accept or decline different intensities of painful electric shocks in exchange of monetary rewards.
METHODS


Participants (n = 90) were divided into three groups that were exposed to different distributions of monetary rewards. Monetary offers ranged linearly from $0 to $5 or $10 in groups 1 and 2, respectively, and exponentially from $0 to $5 in group 3. Pain offers ranged from pain detection to pain tolerance thresholds. The value of pain was assessed by identifying the indifference points corresponding to a 50% chance of accepting a certain level of pain for a given monetary reward.
RESULTS


The value of pain increased quadratically as a function of the anticipated pain intensity and was found to be relative to the mean and standard deviation of monetary offers. Moreover, decision times increased as a function of the intensity of accepted painful stimulations. Finally, inter-individual differences in psychological traits related to harm avoidance and persistence influenced the value of pain.
CONCLUSIONS


This is the first demonstration that the value of pain follows a curvilinear function and is relative to the mean and standard deviation of competing monetary rewards. These new observations significantly contribute to our understanding of how pain is assigned value when making decisions between avoiding pain and obtaining rewards.
SIGNIFICANCE


This work provides a description of the pain value function indicating how much people are willing to pay to avoid different intensities of pain. We found that the function was curvilinear, suggesting that the same unit of subjective pain has more value in the high vs. low pain range. Moreover, the pain value was influenced by the experimental manipulation of the rewards distribution and of the inter-individual differences in harm avoidance and persistence. Altogether, the present study provides a detailed account of how subjectively experienced pain is assigned value.",2022,"Moreover, decision times increased as a function of the intensity of accepted painful stimulations.","['Participants (n = 90', 'participants had to accept or decline different intensities of painful electric shocks in exchange of monetary rewards']",[],"['pain value', 'value of pain', 'Pain value']","[{'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013781', 'cui_str': 'Exposure to electric current, with passage of current through tissue'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",90.0,0.176205,"Moreover, decision times increased as a function of the intensity of accepted painful stimulations.","[{'ForeName': 'Hocine', 'Initials': 'H', 'LastName': 'Slimani', 'Affiliation': 'Department of Psychology, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Rainville', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Department of Psychology, McGill University, Montréal, Québec, Canada.'}]","European journal of pain (London, England)",['10.1002/ejp.1895']
1406,34854740,"Engineered mesoporous silica reduces long-term blood glucose, HbA1c, and improves metabolic parameters in prediabetics.","Aim:  To investigate the effect of oral consumption of engineered mesoporous silica particles, SiPore15 ® , on long-term blood glucose levels and other metabolic parameters in individuals with prediabetes and newly diagnosed Type 2 diabetes.  Method:  An open-label, single-arm, multicenter trial was conducted in which SiPore15 was consumed three times daily for 12 weeks. Hemoglobin A1c (HbA1c, primary end point) and an array of metabolic parameters were measured at baseline and throughout the trial.  Result:  SiPore15 treatment significantly reduced HbA1c by a clinically meaningful degree and improved several disease-associated parameters with minimal side effects.  Conclusion:  The results from this study demonstrate the potential use of SiPore15 as a treatment for prediabetes that may also delay or prevent the onset of Type 2 diabetes.",2022,SiPore15 treatment significantly reduced HbA1c by a clinically meaningful degree and improved several disease-associated parameters with minimal side effects.  ,['individuals with prediabetes and newly diagnosed Type 2 diabetes'],"['oral consumption of engineered mesoporous silica particles, SiPore15 ®']","['Hemoglobin A1c (HbA1c, primary end\xa0point) and an array of metabolic parameters']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0014279', 'cui_str': 'Engineering'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0523069,SiPore15 treatment significantly reduced HbA1c by a clinically meaningful degree and improved several disease-associated parameters with minimal side effects.  ,"[{'ForeName': 'Jeanha', 'Initials': 'J', 'LastName': 'Baek', 'Affiliation': 'Sigrid Therapeutics AB, Norrtullsgatan 6, Stockholm, SE-113 29, Sweden.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Robert-Nicoud', 'Affiliation': 'Sigrid Therapeutics AB, Norrtullsgatan 6, Stockholm, SE-113 29, Sweden.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Herrera Hidalgo', 'Affiliation': 'Sigrid Therapeutics AB, Norrtullsgatan 6, Stockholm, SE-113 29, Sweden.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Borg', 'Affiliation': 'Sigrid Therapeutics AB, Norrtullsgatan 6, Stockholm, SE-113 29, Sweden.'}, {'ForeName': 'Muhammad N', 'Initials': 'MN', 'LastName': 'Iqbal', 'Affiliation': 'Sigrid Therapeutics AB, Norrtullsgatan 6, Stockholm, SE-113 29, Sweden.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Berlin', 'Affiliation': '1.618 Consulting LLC, Philadelphia, PA 19107, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lindgren', 'Affiliation': 'Sigrid Therapeutics AB, Norrtullsgatan 6, Stockholm, SE-113 29, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Waara', 'Affiliation': 'Sigrid Therapeutics AB, Norrtullsgatan 6, Stockholm, SE-113 29, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Uddén', 'Affiliation': 'Sigrid Therapeutics AB, Norrtullsgatan 6, Stockholm, SE-113 29, Sweden.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Pietiläinen', 'Affiliation': 'Obesity Research Unit, Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Helsinki, 00014, Finland.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Bengtsson', 'Affiliation': 'Department of Molecular Biosciences, The Wenner-Gren Institute, Stockholm University, Stockholm, SE-106 91, Sweden.'}]","Nanomedicine (London, England)",['10.2217/nnm-2021-0235']
1407,34844002,Non-invasive evaluation of meibomian gland morphology and tear film and anterior segment parameters in women with polycystic ovarian syndrome.,"PURPOSE


To compare the meibomian glands (MG), non-invasive tear film break-up time (NITBUT), and corneal and anterior segment measurements in patients with polycystic ovary syndrome and healthy women.
METHODS


The study included 66 polycystic ovarian syndrome (PCOS) patients and 42 healthy volunteers aged 18-35 years. The first and average NITBUT, MG loss, mean keratometry (Km), central (CCT) and thinnest (TCT) corneal thicknesses, anterior chamber depth (ACD), anterior chamber volume (ACV), irido-corneal angle (ICA), corneal volume (CV) and Ocular Surface Disease Index (OSDI) results were analyzed.
RESULTS


The mean MG loss values were 29.9 ± 11.9 and 20.8 ± 11.0 in the PCOS and control groups, respectively (p < 0.001). MG loss (meiboscale ≥ 1) was determined in 64 (96.9%) eyes in the PCOS group and in 36 (85.7%) eyes in the control group. There was no significant difference between the groups in respect of NITBUT, OSDI, Km, CCT, TCT, ACD, ACV, ICA and CV values (p > 0.05, for all).
CONCLUSION


MG loss is a physiological process which is distinct in PCOS patients, but does not cause tear film alterations. Further studies are needed to show the contributing factors of MGD in PCOS patients.",2022,"There was no significant difference between the groups in respect of NITBUT, OSDI, Km, CCT, TCT, ACD, ACV, ICA and CV values (p>0.05, for all).
","['women with polycystic ovarian syndrome', '66 polycystic ovarian syndrome (PCOS) patients and 42 healthy volunteers aged18- 35 years', 'patients with polycystic ovary syndrome and healthy women']","['meibomian glands (MG), non-invasive tear film break-up time (NITBUT), and corneal and anterior segment measurements']","['MG loss (meiboscale≥1', 'average NITBUT, MG loss, mean keratometry (Km), central (CCT) and thinnest (TCT) corneal thicknesses, anterior chamber depth (ACD), anterior chamber volume (ACV), irido-corneal angle (ICA), corneal volume (CV) and Ocular Surface Disease Index (OSDI', 'respect of NITBUT, OSDI, Km, CCT, TCT, ACD, ACV, ICA and CV values (p>0.05, for all', 'mean MG loss values']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0677634', 'cui_str': 'Reptilase time'}, {'cui': 'C0002873', 'cui_str': 'Anemia of chronic disease'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C0201519', 'cui_str': 'Islet cell antibody measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",66.0,0.0148318,"There was no significant difference between the groups in respect of NITBUT, OSDI, Km, CCT, TCT, ACD, ACV, ICA and CV values (p>0.05, for all).
","[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Yücekul', 'Affiliation': 'Department of Ophthalmology, Haseki Training and Research Hospital, Sultangazi, Istanbul 34265, Turkey. Electronic address: burcuykt@hotmail.com.'}, {'ForeName': 'Beril', 'Initials': 'B', 'LastName': 'Gürlek', 'Affiliation': 'Department of Obstetrics and Gynecology, Recep Tayyip Erdogan University Faculty of Medicine, Rize, Turkey.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102654']
1408,34849546,Clinical and biomarker modifiers of vitamin D treatment response: the Multi-Ethnic Study of Atherosclerosis.,"BACKGROUND


Different 25-hydroxyvitamin D [25(OH)D] thresholds for treatment with vitamin D supplementation have been suggested and are derived almost exclusively from observational studies. Whether other characteristics, including race/ethnicity, BMI, and estimated glomerular filtration rate (eGFR), should also influence the threshold for treatment is unknown.
OBJECTIVES


The aim was to identify clinical and biomarker characteristics that modify the response to vitamin D supplementation.
METHODS


A total of 666 older adults in the Multi-Ethnic Study of Atherosclerosis (MESA) were randomly assigned to 16 wk of oral vitamin D3 (2000 IU/d; n = 499) or placebo (n = 167). Primary outcomes were changes in serum parathyroid hormone (PTH) and 1,25-dihydroxyvitamin D [1,25(OH)2D] concentrations from baseline to 16 wk.
RESULTS


Among 666 participants randomly assigned (mean age: 72 y; 53% female; 66% racial/ethnic minority), 611 (92%) completed the study. The mean (SD) change in PTH was -3 (16) pg/mL with vitamin D3 compared with 2 (18) pg/mL with placebo (estimated mean difference: -5; 95% CI: -8, -2 pg/mL). Within the vitamin D3 group, lower baseline 25-hydroxyvitamin D [25(OH)D] was associated with a larger decline in PTH in a nonlinear fashion. With baseline 25(OH)D ≥30 ng/mL as the reference, 25(OH)D <20 ng/mL was associated with a larger decline in PTH with vitamin D3 supplementation (-10; 95% CI: -15, -6 pg/mL), whereas 25(OH)D of 20-30 ng/mL was not (-2; 95% CI: -6, 1 pg/mL). A segmented threshold model identified a baseline 25(OH)D concentration of 21 (95% CI: 13, 31) ng/mL as an inflection point for difference in change in PTH. Race/ethnicity, BMI, and eGFR did not modify vitamin D treatment response. There was no significant change in 1,25(OH)2D in either treatment group.
CONCLUSIONS


Of characteristics most commonly associated with vitamin D metabolism, only baseline 25(OH)D <20 ng/mL modified the PTH response to vitamin D supplementation, providing support from a clinical trial to use this threshold to define insufficiency. This trial was registered at clinicaltrials.gov as NCT02925195.",2022,"Within the vitamin D3 group, lower baseline 25(OH)D was associated with a larger decline in PTH in a non-linear fashion.","['666 participants randomized (mean age 72 years, 53% female, 66% racial/ethnic minority), 611 (92%) completed the study', '666 older adults in the Multi-Ethnic Study of Atherosclerosis (MESA']","['vitamin D3', 'vitamin D supplementation', 'vitamin D', 'oral vitamin D3', 'placebo']","['Mean (SD) change in PTH', 'serum parathyroid hormone (PTH) and 1,25-dihydroxyvitamin D (1,25(OH)2D) concentrations']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0370232', 'cui_str': '1,25-dihydroxyvitamin D'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",666.0,0.764003,"Within the vitamin D3 group, lower baseline 25(OH)D was associated with a larger decline in PTH in a non-linear fashion.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Prince', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kayleen', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Norrina B', 'Initials': 'NB', 'LastName': 'Allen', 'Affiliation': 'Department of Internal Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Burke', 'Affiliation': 'Division of Public Health Sciences Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Hoofnagle', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'The Institute for Translational Genomics and Population Sciences, Department of Pediatrics, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Kiang J', 'Initials': 'KJ', 'LastName': 'Liu', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'McClelland', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Michos', 'Affiliation': 'Division of Cardiology, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Psaty', 'Affiliation': 'Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, and Health Services, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Shea', 'Affiliation': 'Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Rice', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jerome I', 'Initials': 'JI', 'LastName': 'Rotter', 'Affiliation': 'The Institute for Translational Genomics and Population Sciences, Department of Pediatrics, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Siscovick', 'Affiliation': 'New York Academy of Medicine, New York, NY, USA.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Tracy', 'Affiliation': 'Department of Biochemistry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Karol E', 'Initials': 'KE', 'LastName': 'Watson', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Kestenbaum', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab390']
1409,34849536,Effect of maternal prenatal and postpartum vitamin D supplementation on offspring bone mass and muscle strength in early childhood: follow-up of a randomized controlled trial.,"BACKGROUND


Maternal vitamin D status during pregnancy and lactation is a modifiable factor that may influence offspring musculoskeletal outcomes. However, few randomized trials have tested the effects of prenatal or postpartum vitamin D supplementation on offspring bone and muscle development.
OBJECTIVES


The aim was to examine hypothesized effects of improvements in early-life vitamin D status on childhood musculoskeletal health in Dhaka, Bangladesh.
METHODS


In a previously completed, double-blind, dose-ranging trial, healthy pregnant women (n = 1300) were recruited at 17-24 weeks' gestation and randomly assigned to a prenatal/postpartum regimen of 0/0, 4200/0, 16,800/0, 28,000/0, or 28,000/28,000 IU cholecalciferol (vitamin D3)/wk until 26 wk postpartum. In this new report, we describe additional follow-up at 4 y of age (n = 642) for longer-term outcomes. Bone mineral content (BMC) and areal bone mineral density (aBMD) were measured by DXA. Grip strength was tested using a hand-held dynamometer. The primary comparison was children of women assigned to 28,000 IU/wk prenatally compared with placebo. Differences are expressed as means and 95% CIs.
RESULTS


Total-body-less-head (TBLH) BMC, TBLH aBMD, and grip strength were similar in the combined high-dose prenatal (28,000/0 and 28,000/28,000 IU/wk) compared with placebo groups (mean difference [95% CI] = 0.61 g [-10.90, 12.13], 0.0004 g/cm2 [-0.0089, 0.0097], and 0.02 kg [-0.26, 0.31], respectively). In dose-ranging analyses, TBLH BMC and aBMD, whole-body BMC and aBMD, and grip strength in each of the prenatal vitamin D groups were not significantly different from placebo (P > 0.05 for all comparisons). Only head aBMD was greater in children of women assigned to the 28,000/28,000-IU regimen compared with placebo (mean difference [95% CI] = 0.024 g/cm2 [0.0009, 0.047], P = 0.042); the effect was attenuated upon adjustment for child height, weight, and sex (P = 0.11).
CONCLUSIONS


Maternal prenatal, with or without postpartum, vitamin D supplementation does not improve child BMC, aBMD, or grip strength at 4 y of age. The MDIG trial and present follow-up study were registered prospectively at www.clinicaltrials.gov as NCT01924013 and NCT03537443, respectively.",2022,Only head aBMD was greater in children of women assigned to the 28000;28000 IU regimen versus placebo (mean difference [95% CI],"['healthy pregnant women (n = 1300', 'early childhood']","['maternal prenatal and postpartum vitamin D supplementation', 'vitamin D supplementation', 'placebo', 'postpartum vitamin D supplementation', 'cholecalciferol']","['Grip strength', 'childhood musculoskeletal health', 'Bone mineral content (BMC) and areal density (aBMD', 'TBLH BMC and aBMD, whole body (WB) BMC and aBMD, and grip strength', 'Total-body-less-head (TBLH) BMC, TBLH aBMD, and grip strength', 'head aBMD', 'child BMC, aBMD or grip strength']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0545595', 'cui_str': 'Cranial and facial bones'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",1300.0,0.467831,Only head aBMD was greater in children of women assigned to the 28000;28000 IU regimen versus placebo (mean difference [95% CI],"[{'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': ""O'Callaghan"", 'Affiliation': 'Centre for Global Child Health and SickKids Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Shaila S', 'Initials': 'SS', 'LastName': 'Shanta', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Fariha', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Harrington', 'Affiliation': 'Department of Pediatrics, Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Abdullah Al', 'Initials': 'AA', 'LastName': 'Mahmud', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Abby L', 'Initials': 'AL', 'LastName': 'Emdin', 'Affiliation': 'Centre for Global Child Health and SickKids Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'Gernand', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Abrams', 'Affiliation': 'Department of Pediatrics, Dell Medical School at the University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Moore', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Roth', 'Affiliation': 'Centre for Global Child Health and SickKids Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab396']
1410,34850368,"Pharmacokinetics and Bioequivalence of Sitagliptin Phosphate/Metformin Hydrochloride Tablets in Healthy Chinese Subjects: A Randomized, Open-Label, Crossover Study.","OBJECTIVE


Our objective was to evaluate the pharmacokinetics and bioequivalence of test and reference (JANUMET ® ) formulations of sitagliptin phosphate/metformin hydrochloride tablets at a single dose of 50 mg/850 mg.
METHODS


The study was a randomized, open-label, two-period, double-crossover trial. Volunteers under fasting (n = 24) and fed (n = 24) conditions were given a single oral dose of test or reference formulations of sitagliptin phosphate/metformin hydrochloride tablets 50 mg/850 mg. We used the liquid chromatography tandem mass spectrometry method to determine the concentrations of sitagliptin and metformin in the plasma of subjects. Pharmacokinetic metrics were calculated using the WinNonlin 7.0 program, and bioequivalence was evaluated using SAS 9.4.
RESULTS


Under the fasting condition, the 90% confidence intervals (CIs) of geometric mean ratio for maximum plasma drug concentration (C max ), area under the plasma concentration-time curve from time zero to time t (AUC 0-t ), and AUC from time zero to infinity (AUC 0-∞ ) of sitagliptin between the test and reference groups were 101.70-120.62%, 99.81-105.61%, and 100.27-106.12%, respectively; for metformin, they were 90.39-111.48%, 94.76-109.12%, and 95.76-110.38%, respectively. Under the fed condition, they were 102.12-117.31%, 100.80-107.81%, and 100.82-107.78%, respectively, for sitagliptin and 95.53-105.22%, 92.76-103.07%, and 93.40-104.14%, respectively, for metformin. Both were generally well-tolerated.
CONCLUSION


The two formulations of sitagliptin phosphate/metformin hydrochloride tablets were bioequivalent under fasting and fed conditions in healthy Chinese subjects.",2022,The two formulations of sitagliptin phosphate/metformin hydrochloride tablets were bioequivalent under fasting and fed conditions in healthy Chinese subjects.,"['Volunteers under fasting (n = 24) and fed (n = 24) conditions', 'healthy Chinese subjects', 'Healthy Chinese Subjects']","['sitagliptin phosphate/metformin hydrochloride tablets', 'Sitagliptin Phosphate/Metformin Hydrochloride Tablets']","['Pharmacokinetic metrics', 'tolerated', 'confidence intervals (CIs) of geometric mean ratio for maximum plasma drug concentration (C max ), area under the plasma concentration-time curve from time zero to time t (AUC 0-t ), and AUC from time zero to infinity (AUC 0-∞ ) of sitagliptin']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C1667080', 'cui_str': 'Sitagliptin phosphate'}, {'cui': 'C0770893', 'cui_str': 'Metformin hydrochloride'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]",,0.0255611,The two formulations of sitagliptin phosphate/metformin hydrochloride tablets were bioequivalent under fasting and fed conditions in healthy Chinese subjects.,"[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Shi', 'Affiliation': 'Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Pharmacy, Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Fei-Fei', 'Initials': 'FF', 'LastName': 'Sun', 'Affiliation': 'Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Shu-Qin', 'Initials': 'SQ', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Xiao-Meng', 'Initials': 'XM', 'LastName': 'Gao', 'Affiliation': 'Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Ya-Ping', 'Initials': 'YP', 'LastName': 'Ma', 'Affiliation': 'Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China. caoyu1767@163.com.'}]",Drugs in R&D,['10.1007/s40268-021-00371-2']
1411,34854112,"Metronidazole gel (0.75%) in Japanese patients with rosacea: A randomized, vehicle-controlled, phase 3 study.","Topical metronidazole is not currently approved in Japan as a treatment for the indication of rosacea, although 0.75% metronidazole gel was authorized in 2014 for the management of cancerous skin ulcers. We conducted a randomized, double-blind, vehicle-controlled study to evaluate the efficacy and safety of 0.75% metronidazole gel in Japanese patients with inflammatory lesions (papules/pustules) and erythema associated with moderate to severe rosacea. Overall, 130 patients were randomly assigned to receive 0.75% metronidazole gel (n = 65) or vehicle (n = 65), and 120 patients completed 12 weeks of treatment. The primary efficacy outcome was the proportion of patients who achieved both of the following at week 12: an improvement of >50% in the number of inflammatory lesions (papules/pustules) and a positive change of at least one degree in erythema severity. This composite outcome was achieved by 72.3% of metronidazole-treated patients versus 36.9% of vehicle-treated patients, with the between-group difference demonstrating significant improvement with 0.75% metronidazole gel (p < 0.0001). All secondary efficacy endpoints (patients achieving a score of ≥3 for percent change in the number of inflammatory lesions at week 12; patients achieving a score of ≥3 for change in erythema severity at week 12; patients achieving an Investigator's Global Assessment score of 0 or 1 at week 12; percent change over time in the number of inflammatory lesions; change over time in erythema severity) also showed improvement in the 0.75% metronidazole gel group. The incidence of adverse events was higher with metronidazole (40.0%) than with vehicle (29.2%). Of these, treatment-related, treatment-emergent adverse events occurred in 9.2% and 6.2% in the metronidazole and the vehicle group, respectively, but there were no new safety concerns. Overall, the results of this study have confirmed the efficacy and safety of 0.75% metronidazole gel in Japanese patients with rosacea.",2022,The incidence of adverse events was higher with metronidazole (40.0%) than with vehicle (29.2%).,"['Japanese patients with rosacea', '130 patients', 'Japanese patients with inflammatory lesions (papules/pustules) and erythema associated with moderate to severe rosacea']","['metronidazole', 'metronidazole gel', 'Metronidazole gel', 'Topical metronidazole']","['number of inflammatory lesions', 'adverse events', 'incidence of adverse events', 'number of inflammatory lesions (papules/pustules', 'number of inflammatory lesions; change over time in erythema severity', 'efficacy and safety', 'erythema severity']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0332563', 'cui_str': 'Papule'}, {'cui': 'C0241157', 'cui_str': 'Pustule'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332563', 'cui_str': 'Papule'}, {'cui': 'C0241157', 'cui_str': 'Pustule'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",130.0,0.162338,The incidence of adverse events was higher with metronidazole (40.0%) than with vehicle (29.2%).,"[{'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Miyachi', 'Affiliation': 'Graduate School of Public Health, Shizuoka Graduate University of Public Health, Shizuoka, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Dermatology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Tomomitsu', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Clinical Development Department, Maruho Co., Ltd, Kyoto, Japan.'}, {'ForeName': 'Chie', 'Initials': 'C', 'LastName': 'Fujii', 'Affiliation': 'Clinical Development Department, Maruho Co., Ltd, Kyoto, Japan.'}]",The Journal of dermatology,['10.1111/1346-8138.16254']
1412,34854808,Primary trabeculectomy versus primary glaucoma eye drops for newly diagnosed advanced glaucoma: TAGS RCT.,"BACKGROUND


Patients diagnosed with advanced primary open-angle glaucoma are at a high risk of lifetime blindness. Uncertainty exists about whether primary medical management (glaucoma eye drops) or primary surgical treatment (augmented trabeculectomy) provide the best and safest patient outcomes.
OBJECTIVES


To compare primary medical management with primary surgical treatment (augmented trabeculectomy) in patients with primary open-angle glaucoma presenting with advanced disease in terms of health-related quality of life, clinical effectiveness, safety and cost-effectiveness.
DESIGN


This was a two-arm, parallel, multicentre, pragmatic randomised controlled trial.
SETTING


Secondary care eye services.
PARTICIPANTS


Adult patients presenting with advanced primary open-angle glaucoma in at least one eye, as defined by the Hodapp-Parrish-Anderson classification of severe glaucoma.
INTERVENTION


Primary medical treatment - escalating medical management with glaucoma eye drops. Primary trabeculectomy treatment - trabeculectomy augmented with mitomycin C.
MAIN OUTCOME MEASURES


The primary outcome was health-related quality of life measured with the Visual Function Questionnaire-25 at 2 years post randomisation. Secondary outcomes were mean intraocular pressure; EQ-5D-5L; Health Utilities Index 3; Glaucoma Utility Index; cost and cost-effectiveness; generic, vision-specific and disease-specific health-related quality of life; clinical effectiveness; and safety.
RESULTS


A total of 453 participants were recruited. The mean age of the participants was 67 years (standard deviation 12 years) in the trabeculectomy arm and 68 years (standard deviation 12 years) in the medical management arm. Over 65% of participants were male and more than 80% were white. At 24 months, the mean difference in Visual Function Questionnaire-25 score was 1.06 (95% confidence interval -1.32 to 3.43;  p  = 0.383). There was no evidence of a difference between arms in the EQ-5D-5L score, the Health Utilities Index or the Glaucoma Utility Index. At 24 months, the mean intraocular pressure was 12.40 mmHg in the trabeculectomy arm and 15.07 mmHg in the medical management arm (mean difference -2.75 mmHg, 95% confidence interval -3.84 to -1.66 mmHg;  p  < 0.001). Fewer types of glaucoma eye drops were required in the trabeculectomy arm. LogMAR visual acuity was slightly better in the medical management arm (mean difference 0.07, 95% confidence interval 0.02 to 0.11;  p  = 0.006) than in the trabeculectomy arm. There was no evidence of difference in safety between the two arms. A discrete choice experiment updated the utility values for the Glaucoma Utility Index. The within-trial economic analysis found a small increase in the mean EQ-5D-5L score (0.04) and that trabeculectomy has a higher probability of being cost-effective than medical management. The incremental cost of trabeculectomy per quality-adjusted life-year was £45,456. Therefore, at 2 years, surgery is unlikely to be considered cost-effective at a threshold of £20,000 per quality-adjusted life-year. When extrapolated over a patient's lifetime in a model-based analysis, trabeculectomy, compared with medical treatment, was associated with higher costs (average £2687), a larger number of quality-adjusted life-years (average 0.28) and higher incremental cost per quality-adjusted life-year gained (average £9679). The likelihood of trabeculectomy being cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life year gained was 73%.
CONCLUSIONS


Our results suggested that there was no difference between treatment arms in health-related quality of life, as measured with the Visual Function Questionnaire-25 at 24 months. Intraocular pressure was better controlled in the trabeculectomy arm, and this may reduce visual field progression. Modelling over the patient's lifetime suggests that trabeculectomy may be cost-effective over the range of values of society's willingness to pay for a quality-adjusted life-year.
FUTURE WORK


Further follow-up of participants will allow us to estimate the long-term differences of disease progression, patient experience and cost-effectiveness.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN56878850.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 25, No. 72. See the NIHR Journals Library website for further project information.",2021,"There was no evidence of a difference between arms in the EQ-5D-5L score, the Health Utilities Index or the Glaucoma Utility Index.","['newly diagnosed advanced glaucoma', 'A total of 453 participants were recruited', 'The mean age of the participants was 67 years (standard deviation 12 years) in the trabeculectomy arm and 68 years (standard deviation 12 years) in the medical management arm', 'patients with primary open-angle glaucoma presenting with advanced disease in terms of health-related', 'Patients diagnosed with advanced primary open-angle glaucoma', 'Secondary care eye services', 'Adult patients presenting with advanced primary open-angle glaucoma in at least one eye, as defined by the Hodapp-Parrish-Anderson classification of severe glaucoma']","['primary medical management (glaucoma eye drops) or primary surgical treatment (augmented trabeculectomy', 'Primary trabeculectomy treatment - trabeculectomy augmented with mitomycin C', 'trabeculectomy', 'primary surgical treatment (augmented trabeculectomy', 'Primary trabeculectomy', 'Primary medical treatment - escalating medical management with glaucoma eye drops']","['Visual Function Questionnaire-25 score', 'LogMAR visual acuity', 'mean EQ-5D-5L score', 'quality of life, clinical effectiveness, safety and cost-effectiveness', 'health-related quality of life', 'EQ-5D-5L score, the Health Utilities Index or the Glaucoma Utility Index', 'health-related quality of life measured with the Visual Function Questionnaire-25', 'mean intraocular pressure', 'mean intraocular pressure; EQ-5D-5L; Health Utilities Index 3; Glaucoma Utility Index; cost and cost-effectiveness; generic, vision-specific and disease-specific health-related quality of life; clinical effectiveness; and safety', 'Intraocular pressure']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0857112', 'cui_str': 'Bilateral glaucoma'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",453.0,0.214314,"There was no evidence of a difference between arms in the EQ-5D-5L score, the Health Utilities Index or the Glaucoma Utility Index.","[{'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'King', 'Affiliation': 'Department of Ophthalmology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Fernie', 'Affiliation': 'Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Kernohan', 'Affiliation': 'Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Azuara-Blanco', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Burr', 'Affiliation': 'School of Medicine, Medical and Biological Sciences, University of St Andrews, St Andrews, UK.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Homer', 'Affiliation': 'Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Hosein', 'Initials': 'H', 'LastName': 'Shabaninejad', 'Affiliation': 'Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Sparrow', 'Affiliation': 'Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garway-Heath', 'Affiliation': 'Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Barton', 'Affiliation': 'Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta25720']
1413,34872404,"The effects of atorvastatin on emotional processing, reward learning, verbal memory and inflammation in healthy volunteers: An experimental medicine study.","BACKGROUND


Growing evidence from clinical trials and epidemiological studies suggests that statins can have clinically significant antidepressant effects, potentially related to anti-inflammatory action on several neurobiological structures. However, the underlying neuropsychological mechanisms of these effects remain unexplored.
AIMS


In this experimental medicine trial, we investigated the 7-day effects of the lipophilic statin, atorvastatin on a battery of neuropsychological tests and inflammation in healthy volunteers.
METHODS


Fifty healthy volunteers were randomised to either 7 days of atorvastatin 20 mg or placebo in a double-blind design. Participants were assessed with psychological questionnaires and a battery of well-validated behavioural tasks assessing emotional processing, which is sensitive to putative antidepressant effects, reward learning and verbal memory, as well as the inflammatory marker, C-reactive protein.
RESULTS


Compared to placebo, 7-day atorvastatin increased the recognition ( p  = 0.006), discriminability ( p  = 0.03) and misclassifications ( p  = 0.04) of fearful facial expression, independently from subjective states of mood and anxiety, and C-reactive protein levels. Otherwise, atorvastatin did not significantly affect any other psychological and behavioural measure, nor peripheral C-reactive protein.
CONCLUSIONS


Our results reveal for the first time the early influence of atorvastatin on emotional cognition by increasing the processing of anxiety-related stimuli (i.e. increased recognition, discriminability and misclassifications of fearful facial expression) in healthy volunteers, in the absence of more general effects on negative affective bias. Further studies exploring the effects of statins in depressed patients, especially with raised inflammatory markers, may clarify this finding and inform future clinical trials.",2021,"Compared to placebo, 7-day atorvastatin increased the recognition ( p  = 0.006), discriminability ( p  = 0.03) and misclassifications ( p  = 0.04) of fearful facial expression, independently from subjective states of mood and anxiety, and C-reactive protein levels.","['depressed patients', 'Fifty healthy volunteers', 'healthy volunteers']","['lipophilic statin, atorvastatin', 'atorvastatin 20\u2009mg or placebo', 'placebo, 7-day atorvastatin', 'atorvastatin']","['emotional cognition', 'subjective states of mood and anxiety, and C-reactive protein levels', 'emotional processing, reward learning, verbal memory and inflammation', 'psychological and behavioural measure, nor peripheral C-reactive protein']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1379773', 'cui_str': 'atorvastatin 20 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",50.0,0.0453392,"Compared to placebo, 7-day atorvastatin increased the recognition ( p  = 0.006), discriminability ( p  = 0.03) and misclassifications ( p  = 0.04) of fearful facial expression, independently from subjective states of mood and anxiety, and C-reactive protein levels.","[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'De Giorgi', 'Affiliation': 'Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Martens', 'Affiliation': 'Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Rizzo Pesci', 'Affiliation': 'Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Cowen', 'Affiliation': 'Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/02698811211060307']
1414,34895510,"Effects of delayed versus immediate umbilical cord clamping in reducing death or major disability at 2 years corrected age among very preterm infants (APTS): a multicentre, randomised clinical trial.","BACKGROUND


Very preterm infants are at increased risk of adverse outcomes in early childhood. We assessed whether delayed clamping of the umbilical cord reduces mortality or major disability at 2 years in the APTS Childhood Follow Up Study.
METHODS


In this long-term follow-up analysis of the multicentre, randomised APTS trial in 25 centres in seven countries, infants (<30 weeks gestation) were randomly assigned before birth (1:1) to have clinicians aim to delay clamping for 60 s or more or clamp within 10 s of birth, both without cord milking. The primary outcome was death or major disability (cerebral palsy, severe visual loss, deafness requiring a hearing aid or cochlear implants, major language or speech problems, or cognitive delay) at 2 years corrected age, analysed in the intention-to-treat population. This trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12610000633088).
FINDINGS


Between Oct 21, 2009, and Jan 6, 2017, consent was obtained for follow-up for 1531 infants, of whom 767 were randomly assigned to delayed clamping and 764 to immediate clamping. 384 (25%) of 1531 infants were multiple births, 862 (56%) infants were male, and 505 (33%) were born before 27 weeks gestation. 564 (74%) of 767 infants assigned to delayed clamping and 726 (96%) of 764 infants assigned to immediate clamping received treatment that fully adhered to the protocol. Death or major disability was determined in 1419 (93%) infants and occurred in 204 (29%) of 709 infants who were assigned to delayed clamping versus 240 (34%) of 710 assigned to immediate clamping, (relative risk [RR]) 0·83, 95% CI 0·72-0·95; p=0·010). 60 (8%) of 725 infants in the delayed clamping group and 81 (11%) of 720 infants in the immediate clamping group died by 2 years of age (RR 0·70, 95% CI 0·52-0·95); among those who survived, major disability at 2 years occurred in 23% (144/627) versus 26% (159/603) of infants, respectively (RR 0·88, 0·74-1·04).
INTERPRETATION


Clamping the umbilical cord at least 60 s after birth reduced the risk of death or major disability at 2 years by 17%, reflecting a 30% reduction in relative mortality with no difference in major disability.
FUNDING


Australian National Health and Medical Research Council.",2022,"Death or major disability was determined in 1419 (93%) infants and occurred in 204 (29%) of 709 infants who were assigned to delayed clamping versus 240 (34%) of 710 assigned to immediate clamping, (relative risk [RR])","['25 centres in seven countries, infants (<30 weeks gestation', '564 (74%) of 767 infants assigned to delayed clamping and 726 (96%) of 764 infants assigned to', '384 (25%) of 1531 infants were multiple births, 862 (56%) infants were male, and 505 (33%) were born before 27 weeks gestation', 'at 2 years corrected age among very preterm infants (APTS']","['delayed versus immediate umbilical cord clamping', 'delay clamping for 60 s or more or clamp within 10 s of birth, both without cord milking', 'immediate clamping']","['risk of death or major disability', 'relative mortality', 'death or major disability', 'death or major disability (cerebral palsy, severe visual loss, deafness requiring a hearing aid or cochlear implants, major language or speech problems, or cognitive delay', 'Death or major disability']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0026753', 'cui_str': 'Multiple Births'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0003645', 'cui_str': 'APT'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0405737', 'cui_str': 'Umbilical cord clamping'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C1301509', 'cui_str': 'Severe visual impairment'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0395016', 'cui_str': 'Speech problem'}]",1531.0,0.343798,"Death or major disability was determined in 1419 (93%) infants and occurred in 204 (29%) of 709 infants who were assigned to delayed clamping versus 240 (34%) of 710 assigned to immediate clamping, (relative risk [RR])","[{'ForeName': 'Kristy P', 'Initials': 'KP', 'LastName': 'Robledo', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'William O', 'Initials': 'WO', 'LastName': 'Tarnow-Mordi', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia. Electronic address: william.tarnow-mordi@sydney.edu.au.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Rieger', 'Affiliation': 'RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Suresh', 'Affiliation': 'Flinders Medical Centre, Adelaide, SA, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Carbo', 'Initials': 'C', 'LastName': 'Yeung', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Ghadge', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Helen G', 'Initials': 'HG', 'LastName': 'Liley', 'Affiliation': 'Mater Research, Faculty of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hague', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kluckow', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Lui', 'Affiliation': 'University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Soll', 'Affiliation': 'Ladner College of Medicine, University of Vermont, Burlington, VT, USA; Vermont Oxford Network, Burlington, VT, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Cruz', 'Affiliation': 'Miracle Babies Foundation, Moorebank, NSW, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Keech', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Kirby', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Simes', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(21)00373-4']
1415,34895483,"Single-dose of adrecizumab versus placebo in acute cardiogenic shock (ACCOST-HH): an investigator-initiated, randomised, double-blinded, placebo-controlled, multicentre trial.","BACKGROUND


Cardiogenic shock has a high mortality on optimal therapy. Adrenomedullin is released during cardiogenic shock and is involved in its pathophysiological processes. This study assessed treatment with the humanised, monoclonal, non-neutralising, adrenomedullin antibody adrecizumab, increasing circulating concentrations of adrenomedullin in cardiogenic shock.
METHODS


In this investigator-initiated, placebo-controlled, double-blind, multicentre, randomised trial (ACCOST-HH), patients were recruited from four university hospitals in Germany. Patients were eligible if they were 18 years old or older and hospitalised for cardiogenic shock within the last 48 h. Exclusion criteria were resuscitation for longer than 60 min and cardiogenic shock due to sustained ventricular tachycardia or bradycardia. Adult patients in cardiogenic shock were randomly assigned (1:1) to intravenous adrecizumab (8 mg/kg bodyweight) or placebo using an internet-based software. A block randomisation procedure was applied with stratification by age (older vs younger than 65 years), sex (male vs female), and type of underlying cardiogenic shock (acute myocardial infarction vs other entities). Investigators, patients, and medical staff involved in patient care were masked to group assignment. The primary endpoint was number of days up to day 30 without the need for cardiovascular organ support, defined as vasopressor therapy, inotropes, or mechanical circulatory support (or both) assessed in the intention-to-treat population. Safety outcomes included therapy-emergent serious adverse events, severe adverse events, adverse events, suspected unexpected serious adverse reactions, study drug-related mortality, and total mortality. The trial was registered at ClinicalTrials.gov, NCT03989531, and EudraCT, 2018-002824-17, and is now complete.
FINDINGS


Between April 5, 2019, and Jan 13, 2021, 150 patients were enrolled: 77 (51%) were randomly assigned to adrecizumab and 73 (49%) to placebo. All patients received the allocated treatment. The number of days without the need for cardiovascular organ support was not different between patients receiving adrecizumab or placebo (12·37 days [95% CI 9·80-14·94] vs 14·05 [11·41-16·69]; adjusted mean difference -1·69 days [-5·37 to 2·00]; p=0·37). Serious adverse events occurred in 59 patients receiving adrecizumab and in 57 receiving placebo (odds ratio 0·92 [95% CI 0·43-1·98]; p=0·83). Mortality was not different between groups at 30 days (hazard ratio 0·99 [95% CI 0·60-1·65]; p=0·98) or 90 days (1·10 [0·68-1·77]; p=0·71).
INTERPRETATION


Adrecizumab was well tolerated in patients with cardiogenic shock but did not reduce the need for cardiovascular organ support or improve survival at days 30 and 90.
FUNDING


Adrenomed AG and University Hospital of Hamburg.",2022,"Mortality was not different between groups at 30 days (hazard ratio 0·99 [95% CI 0·60-1·65]; p=0·98) or 90 days (1·10 [0·68-1·77]; p=0·71).
","['patients were recruited from four university hospitals in Germany', 'Patients were eligible if they were 18 years old or older and hospitalised for cardiogenic shock within the last 48 h. Exclusion criteria were resuscitation for longer than 60 min and cardiogenic shock due to sustained ventricular tachycardia or bradycardia', 'age (older vs younger than 65 years), sex (male vs female), and type of underlying cardiogenic shock (acute myocardial infarction vs other entities', 'Adult patients in cardiogenic shock', 'Between April 5, 2019, and Jan 13, 2021, 150 patients were enrolled: 77 (51', 'patients with cardiogenic shock', 'acute cardiogenic shock (ACCOST-HH', '59 patients receiving']","['adrecizumab versus placebo', 'placebo', 'adrecizumab', 'intravenous adrecizumab', 'adrecizumab or placebo']","['Mortality', 'Serious adverse events', 'number of days without the need for cardiovascular organ support', 'number of days up to day 30 without the need for cardiovascular organ support, defined as vasopressor therapy, inotropes, or mechanical circulatory support (or both) assessed in the intention-to-treat population', 'therapy-emergent serious adverse events, severe adverse events, adverse events, suspected unexpected serious adverse reactions, study drug-related mortality, and total mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0750197', 'cui_str': 'Sustained ventricular tachycardia'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",150.0,0.757687,"Mortality was not different between groups at 30 days (hazard ratio 0·99 [95% CI 0·60-1·65]; p=0·98) or 90 days (1·10 [0·68-1·77]; p=0·71).
","[{'ForeName': 'Mahir', 'Initials': 'M', 'LastName': 'Karakas', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany; German Centre for Cardiovascular Research, Partner Site Hamburg/Kiel/Lübeck, Hamburg, Germany. Electronic address: m.karakas@uke.de.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Akin', 'Affiliation': 'Partner Site Heidelberg/Mannheim, Mannheim, Germany; First Department of Medicine, Faculty of Medicine, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Burdelski', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Clemmensen', 'Affiliation': 'Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany; Faculty of Health Sciences, Institute of Regional Health Research, Nykoebing F Hospital, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Grahn', 'Affiliation': 'Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Jarczak', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Keßler', 'Affiliation': 'Department of Internal Medicine II-Cardiology, Medical Center, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Paulus', 'Initials': 'P', 'LastName': 'Kirchhof', 'Affiliation': 'Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany; German Centre for Cardiovascular Research, Partner Site Hamburg/Kiel/Lübeck, Hamburg, Germany; Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'Partner Site Berlin, Berlin, Germany; Department of Cardiology, Campus Benjamin Franklin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Lezius', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Lindner', 'Affiliation': 'Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany; German Centre for Cardiovascular Research, Partner Site Hamburg/Kiel/Lübeck, Hamburg, Germany.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mebazaa', 'Affiliation': 'University of Paris, Department of Anaesthesiology and Critical Care, Hôpitaux Universitaires Saint Louis-Lariboisière, Assistance Publique des Hopitaux de Paris, Paris, France.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Nierhaus', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Ocak', 'Affiliation': 'Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Rottbauer', 'Affiliation': 'Department of Internal Medicine II-Cardiology, Medical Center, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Sinning', 'Affiliation': 'Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany; German Centre for Cardiovascular Research, Partner Site Hamburg/Kiel/Lübeck, Hamburg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Skurk', 'Affiliation': 'Partner Site Berlin, Berlin, Germany; Department of Cardiology, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Gerold', 'Initials': 'G', 'LastName': 'Söffker', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Westermann', 'Affiliation': 'Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany; German Centre for Cardiovascular Research, Partner Site Hamburg/Kiel/Lübeck, Hamburg, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Zapf', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Zengin', 'Affiliation': 'Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': 'Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany; German Centre for Cardiovascular Research, Partner Site Hamburg/Kiel/Lübeck, Hamburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kluge', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00439-2']
1416,34897226,"Viral Suppression Levels in Men Who Have Sex With Men and Transgender Women With Newly Diagnosed HIV and Alcohol Use Disorder in Peru: Results From a Randomized, Double-Blind, Placebo-Controlled Trial Using Oral Naltrexone.","BACKGROUND


Alcohol use disorders (AUDs) are common in men who have sex with men (MSM) and transgender women (TGW) in Peru and undermine antiretroviral therapy (ART) adherence. Oral naltrexone (NTX) is an evidence-based treatment for AUD that has not been assessed in cotreating AUD in MSM/TGW with HIV.
SETTING AND DESIGN


A multi-site, randomized, double-blind, placebo-controlled trial among MSM/TGW with AUD and newly diagnosed with HIV in Lima, Peru.
METHODS


Newly diagnosed MSM/TGW with HIV and AUD were prescribed a single-treatment regimen of EFV/TDF/FTC from 2014 to 2015 and randomized 2:1 to oral NTX (N = 103) or placebo (N = 53) for 24 weeks. The primary and secondary outcomes were proportion achieving viral suppression (VS: HIV-1 RNA < 400 copies/mL) or maximal viral suppression (MVS: HIV-1 RNA < 40 copies/mL) at 24 weeks.
RESULTS


There were no significant differences between the arms in VS (81.6% NTX arm vs 75.5% placebo arm; P = 0.37) or MVS (61.2% NTX arm vs 66.0% placebo arm; P = 0.48). Adherence to study medication was low (mean = 34.6%) overall with only 21.4% of participants meeting recommended adherence levels (≥80% daily doses/month). Participants allocated to NTX had significantly lower adherence compared with placebo for both the first and second 12-week study periods, respectively (44.0% vs 35.2%, P = 0.04; 31.4% vs 35.2%, P = 0.03).
CONCLUSIONS


Findings are inconclusive regarding the use of NTX for treatment of AUD in MSM/TGW newly diagnosed with HIV. VS and MVS levels were high irrespective of allocation. Adherence to study medication was low, requiring further exploration of strategies to optimize adherence to NTX as AUD treatment.",2022,Adherence to study medication was low (mean=34.6%) overall with only 21.4% of participants meeting recommended levels (≥80% daily doses/month).,"['men who have sex with men (MSM) and transgender women (TGW) in Peru and undermine antiretroviral therapy (ART) adherence', 'Newly Diagnosed Men', 'Who Have Sex with Men and Transgender Women with Newly Diagnosed HIV and Alcohol Use Disorder in Peru', 'Newly diagnosed MSM/TGW with AUD', 'MSM/TGW with AUD and newly diagnosed with HIV in Lima, Peru']","['placebo', 'Naltrexone', 'Placebo', 'Oral naltrexone (NTX', 'MVS', 'EFV/TDF/FTC', 'oral NTX', 'NTX']","['proportion achieving viral suppression (VS: HIV-1 RNA<400 copies/mL) or maximal viral suppression', 'VS and MVS levels', 'Viral Suppression Levels', 'HIV-1']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C1822301', 'cui_str': 'Wound tissue undermining'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.777402,Adherence to study medication was low (mean=34.6%) overall with only 21.4% of participants meeting recommended levels (≥80% daily doses/month).,"[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gonzales', 'Affiliation': 'Asociación Civil Impacta Salud y Educación, Lima, Peru.'}, {'ForeName': 'Chethan', 'Initials': 'C', 'LastName': 'Bachireddy', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Grieco', 'Affiliation': 'Vaccine and Infectious Disease and Public Health Science Divisions, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Ding', 'Affiliation': 'Vaccine and Infectious Disease and Public Health Science Divisions, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Samy J', 'Initials': 'SJ', 'LastName': 'Galvez de Leon', 'Affiliation': 'Department of Medicine, Yale School of Medicine, Section of Infectious Diseases, New Haven, CT; and.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ulrich', 'Affiliation': 'Vaccine and Infectious Disease and Public Health Science Divisions, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lama', 'Affiliation': 'Asociación Civil Impacta Salud y Educación, Lima, Peru.'}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Duerr', 'Affiliation': 'Vaccine and Infectious Disease and Public Health Science Divisions, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Altice', 'Affiliation': 'Department of Medicine, Yale School of Medicine, Section of Infectious Diseases, New Haven, CT; and.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002889']
1417,34863052,"Remote transmission monitoring for postoperative perineural analgesia after major orthopedic surgery: A multicenter, randomized, parallel-group, controlled trial.","STUDY OBJECTIVE


After surgery, patients reported the delay in receiving help as the primary factor for poorly controlled pain. This study aimed to compare the effectiveness of patient management through two communication modalities: remote transmission (RT) versus bedside control (BC). We hypothesized that using remote technology for pump programming may provide the best postoperative infusion regimen for the patient's self-assessment of pain and adverse events.
DESIGN


A multicenter, randomized, parallel-group, controlled trial.
SETTING


Anesthesiology department and orthopedic surgery ward at three university hospitals.
PATIENTS


Eighty patients undergoing orthopedic surgery with postoperative perineural patient-controlled analgesia were included.
INTERVENTIONS


Two groups (n = 40 for each group) were formed by randomization. In the postoperative period, perineural analgesia was followed up via an RT system or BC for 72 h.
MEASUREMENTS


A nurse assessed daily pain, sensory and motor blocks and adverse events. Patients completed a questionnaire three times a day and alerted for any problem according to the group (RT system or nurses' follow-up). On the third postoperative day, the nurse removed the catheter, completed the final assessment, and collected the historical data from the pump. A physician's shorter response time to change the patient control analgesia (PCA) program was the primary endpoint.
RESULTS


Of the 80 patients, 71 were analyzed (34 were randomized to the RT group and 37 to the BC group). Fifty-eight pump setting changes were noted. Analysis of repeated evaluations shows that mean time (SD) to change the PCA pump settings was significantly lower in the RT group (20 min (22.3 min)) than in the BC group (55.9 min (71.1 min)); mean difference [95% CI], -35.9 min [-74.3 to 2.4]); β estimation [95% CI], -34 [-63 to -6], p = 0.011). Pain relief, sensory and motor blocks did not differ between the groups: β estimation [95% CI], 0.1 [-0.4 to 0.6], p = 0.753; 0.5 [-0.4 to 1.4], p = 0.255; 0.9 [-0.04 to 1.8], p = 0.687, respectively. β = -34 [-63 to -6], p = 0.011). The consumption of ropivacaine, nurse workload and the cost of the analgesia regimen decreased in the RT group. No differences were noted in satisfaction scores or complication rates.
CONCLUSIONS


The response time for the physician to change the PCA program when necessary was shorter for patients using RT and alerts to the physician were more frequent compared with spot checks by nurses. RT helps to decrease nurses' workload, ropivacaine consumption, and costs but did not affect postoperative pain relief, complication rate, or patient-reported satisfaction score.
IRB CONTACT INFORMATION


Comité de Protection des Personnes, Sud Méditerranée III, Montpellier-Nîmes, France, registration number EudraCT A01698-35.
CLINICAL TRIAL NUMBER


ClinicalTrials.gov ID:NCT02018068 PROTOCOL: The full trial protocol can be accessed at Department of Anesthesiology and Critical Care Medicine, Medical Research and Statistics Unit, Lapeyronie University Hospital, Avenue Doten G Giraud, Montpellier, France. s-bringuierbranchereau@chu-montpellier.fr.",2022,"RT helps to decrease nurses' workload, ropivacaine consumption, and costs but did not affect postoperative pain relief, complication rate, or patient-reported satisfaction score.
","['Eighty patients undergoing orthopedic surgery with postoperative perineural patient-controlled analgesia were included', '80 patients', 'postoperative perineural analgesia after major orthopedic surgery', 'Anesthesiology department and orthopedic surgery ward at three university hospitals']","['EudraCT', 's-bringuierbranchereau@chu-montpellier.fr', 'patient management through two communication modalities: remote transmission (RT) versus bedside control (BC']","['consumption of ropivacaine, nurse workload and the cost of the analgesia regimen', 'Pain relief, sensory and motor blocks', 'mean time (SD) to change the PCA pump settings', 'daily pain, sensory and motor blocks and adverse events', 'response time', 'postoperative pain relief, complication rate, or patient-reported satisfaction score', ""nurses' workload, ropivacaine consumption, and costs"", 'satisfaction scores or complication rates']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",80.0,0.0904749,"RT helps to decrease nurses' workload, ropivacaine consumption, and costs but did not affect postoperative pain relief, complication rate, or patient-reported satisfaction score.
","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Capdevila', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Lapeyronie University Hospital, 34295 Montpellier Cedex 5, France; Inserm Unit 1298 Montpellier NeuroSciences Institute, Montpellier University, 34295 Montpellier Cedex 5, France. Electronic address: x-capdevila@chu-montpellier.fr.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Macaire', 'Affiliation': 'Department of Anesthesia and Pain Management, VinMec Hospital, Hanoi, Viet Nam.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Bernard', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Lapeyronie University Hospital, 34295 Montpellier Cedex 5, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Biboulet', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Lapeyronie University Hospital, 34295 Montpellier Cedex 5, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cuvillon', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Caremeau University Hospital, Nimes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Choquet', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Lapeyronie University Hospital, 34295 Montpellier Cedex 5, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bringuier', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Lapeyronie University Hospital, 34295 Montpellier Cedex 5, France; Department of Medical Statistics, and Epidemiology, Montpellier University Hospital, 34295 Montpellier Cedex 5, France.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110618']
1418,34903539,Effectiveness and cost-effectiveness of a structured social coaching intervention for people with psychosis (SCENE): protocol for a randomised controlled trial.,"INTRODUCTION


People with psychosis tend to have smaller social networks than both people in the general population and other people with long-term health conditions. Small social networks are associated with poor quality of life. Preliminary evidence suggests that coaching patients to increase their social contacts may be effective. In this study, we assessed whether structured social coaching improves the quality of life of patients with psychosis (primary outcome) compared with an active control group, receiving information on local social activities.
METHODS AND ANALYSIS


A structured social coaching intervention was developed based on the literature and refined through stakeholder involvement. It draws on principles from motivational interviewing, solution focused therapy and structured information giving. It is provided over a 6-month period and can be delivered by a range of different mental health professionals. Its effectiveness and cost-effectiveness are assessed in a randomised controlled trial, compared with an active control group, in which participants are given an information booklet on local social activities. Participants are aged 18 or over, have a primary diagnosis of a psychotic disorder (International Classification of Disease: F20-29) and capacity to provide informed consent. Participants are assessed at baseline and at 6, 12 and 18 months after individual randomisation. The primary outcome is quality of life at 6 months (Manchester Short Assessment of Quality of Life). We hypothesise that the effects on quality of life are mediated by an increase in social contacts. Secondary outcomes are symptoms, social situation and time spent in social activities. Costs and cost-effectiveness analyses will consider service use and health-related quality of life.
ETHICS AND DISSEMINATION


National Health Service REC London Hampstead (19/LO/0088) provided a favourable opinion. Findings will be disseminated through a website, social media, scientific papers and user-friendly reports, in collaboration with a lived experience advisory panel.
TRIAL REGISTRATION NUMBER


ISRCTN15815862.",2021,"INTRODUCTION


People with psychosis tend to have smaller social networks than both people in the general population and other people with long-term health conditions.","['Participants are aged 18 or over, have a primary diagnosis of a psychotic disorder (International Classification of Disease: F20-29) and capacity to provide informed consent', 'patients with psychosis (primary outcome', 'people with psychosis (SCENE']","['structured social coaching intervention', 'structured social coaching']","['Effectiveness and cost-effectiveness', 'Costs and cost-effectiveness', 'effectiveness and cost-effectiveness', 'quality of life at 6 months (Manchester Short Assessment of Quality of Life', 'symptoms, social situation and time spent in social activities', 'local social activities', 'quality of life']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205276', 'cui_str': 'Local'}]",,0.0796925,"INTRODUCTION


People with psychosis tend to have smaller social networks than both people in the general population and other people with long-term health conditions.","[{'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Giacco', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK Domenico.Giacco@warwick.ac.uk.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Chevalier', 'Affiliation': 'Unit for Social and Community Psychiatry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Patterson', 'Affiliation': 'Unit for Social and Community Psychiatry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hamborg', 'Affiliation': 'Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Rianna', 'Initials': 'R', 'LastName': 'Mortimer', 'Affiliation': 'Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Webber', 'Affiliation': 'Department of Social Policy and Social Work, University of York, York, UK.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Xanthopoulou', 'Affiliation': 'Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Priebe', 'Affiliation': 'Unit for Social and Community Psychiatry, Queen Mary University of London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2021-050627']
1419,34856961,Racial and weight discrimination associations with pain intensity and pain interference in an ethnically diverse sample of adults with obesity: a baseline analysis of the clustered randomized-controlled clinical trial the goals for eating and moving (GEM) study.,"BACKGROUND


Everyday experiences with racial (RD) and weight discrimination (WD) are risk factors for chronic pain in ethnically diverse adults with obesity. However, the individual or combined effects of RD and WD on pain in adults with obesity is not well understood. There are gender differences and sexual dimorphisms in nociception and pain, but the effect of gender on relationships between RD, WD, and pain outcomes in ethnically diverse adults with obesity is unclear. Thus, the purposes of this study were to: 1) examine whether RD and WD are associated with pain intensity and interference, and 2) explore gender as a moderator of the associations between RD, WD, and pain.
METHODS


This is a baseline data analysis from a randomized, controlled clinical trial of a lifestyle weight-management intervention. Eligible participants were English or Spanish-speaking (ages 18-69 years) and had either a body mass index of ≥30 kg/m 2  or ≥ 25 kg/m 2  with weight-related comorbidity. RD and WD were measured using questions derived from the Experiences of Discrimination questionnaire (EOD). Pain interference and intensity were measured using the PROMIS 29 adult profile V2.1. Linear regression models were performed to determine the associations between WD, RD, gender, and pain outcomes.
RESULTS


Participants (n = 483) reported mild pain interference (T-score: 52.65 ± 10.29) and moderate pain intensity (4.23 ± 3.15). RD was more strongly associated with pain interference in women (b = .47, SE = .08, p < 001), compared to men (b = .14, SE = .07, p = .06). Also, there were no significant interaction effects between RD and gender on pain intensity, or between WD and gender on pain interference or pain intensity.
CONCLUSIONS


Pain is highly prevalent in adults with obesity, and is impacted by the frequencies of experiences with RD and WD. Further, discrimination against adults with obesity and chronic pain could exacerbate existing racial disparities in pain and weight management. Asking ethnically diverse adults with obesity about their pain and their experiences of RD and WD could help clinicians make culturally informed assessment and intervention decisions that address barriers to pain relief and weight loss.
TRIAL REGISTRATION


NCT03006328.",2021,"Also, there were no significant interaction effects between RD and gender on pain intensity, or between WD and gender on pain interference or pain intensity.
","['ethnically diverse adults with obesity', 'adults with obesity', 'Asking ethnically diverse adults with obesity about their pain and their experiences of RD and WD', 'ethnically diverse sample of adults with obesity', 'Eligible participants were English or Spanish-speaking (ages 18-69\u2009years) and had either a body mass index of ≥30\u2009kg/m 2  or\u2009≥']",['lifestyle weight-management intervention'],"['moderate pain intensity', 'pain interference', 'Pain interference and intensity', 'RD', 'pain intensity, or between WD and gender on pain interference or pain intensity', 'mild pain interference', 'RD and WD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}]",29.0,0.135682,"Also, there were no significant interaction effects between RD and gender on pain intensity, or between WD and gender on pain interference or pain intensity.
","[{'ForeName': 'Ericka N', 'Initials': 'EN', 'LastName': 'Merriwether', 'Affiliation': 'New York University, New York, USA. em3766@nyu.edu.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Wittleder', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Gawon', 'Initials': 'G', 'LastName': 'Cho', 'Affiliation': 'New York University, New York, USA.'}, {'ForeName': 'Eushavia', 'Initials': 'E', 'LastName': 'Bogan', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'New York University, New York, USA.'}, {'ForeName': 'Naja', 'Initials': 'N', 'LastName': 'Bostwick', 'Affiliation': 'New York University, New York, USA.'}, {'ForeName': 'Binhuan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ravenell', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Jay', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}]",BMC public health,['10.1186/s12889-021-12199-1']
1420,34908015,Immunological Effects of Adding Bovine Lactoferrin and Reducing Iron in Infant Formula: A Randomized Controlled Trial.,"OBJECTIVES


Compared to formula-fed infants, breastfed infants have a lower risk of infections. Two possible reasons for this are the presence of the anti-infective and anti-inflammatory protein lactoferrin and the lower level of iron in breast milk. We explored how adding bovine lactoferrin and reducing the iron concentration in infant formula affect immunology and risk of infections in healthy infants.
METHODS


In a double-blind controlled trial, term formula-fed (FF) Swedish infants (n = 180) were randomized to receive, from 6 weeks to 6 months of age, a low-iron formula (2 mg/L) with added bovine lactoferrin (1.0 g/L) (Lf+; n = 72); low-iron formula with no added lactoferrin (Lf-; n = 72); and standard formula at 8 mg/L iron and no added lactoferrin (control formula [CF]; n = 36). Cytokines, infections, and infection related treatments were assessed until 12 months of age.
RESULTS


No adverse effects were observed. There were no apparent effects on transforming growth factor beta (TGF-β)1, TGF-β2, tumor necrosis factor alfa (TNF-α) or interleukin2 (IL-2) at 4, 6, or 12 months, except of higher TGF-β2 at 6 months in the CF group in comparison to the low iron groups combined (P = 0.033). No significant differences in otitis, respiratory infections, gastroenteritis, or other monitored infections and treatments were detected for any of the study feeding groups during the first 6 months and only a few and diverging effects were observed between 6 and 12 months.
CONCLUSIONS


Adding bovine lactoferrin and reducing iron from 8 to 2 mg/L in infant formula was safe. No clinically relevant effects on cytokines or infection related morbidity were observed in this well-nourished and healthy population.",2022,No clinically relevant effects on cytokines or infection related morbidity were observed in this well-nourished and healthy population.,"['healthy infants', 'Swedish infants (n\u200a=\u200a180', 'Infant Formula']","['term formula-fed (FF', 'Bovine Lactoferrin', 'low-iron formula (2\u200amg/L) with added bovine lactoferrin (1.0\u200ag/L) (Lf+; n\u200a=\u200a72); low-iron formula with no added lactoferrin (Lf-; n\u200a=\u200a72); and standard formula at 8\u200amg/L iron and no added lactoferrin', 'bovine lactoferrin']","['adverse effects', 'TGF-β1, TGF-β2, TNF-α or IL-2', 'otitis, respiratory infections, gastroenteritis, or other monitored infections and treatments', 'Cytokines, infections, and infection related treatments', 'risk of infections', 'cytokines or infection related morbidity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}]","[{'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C1440867', 'cui_str': 'Bovine lactoferrin'}, {'cui': 'C0860975', 'cui_str': 'Iron low'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0029877', 'cui_str': 'Otitis'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",180.0,0.116994,No clinically relevant effects on cytokines or infection related morbidity were observed in this well-nourished and healthy population.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Björmsjö', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Hernell', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Lönnerdal', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA.'}, {'ForeName': 'Staffan K', 'Initials': 'SK', 'LastName': 'Berglund', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000003367']
1421,34910089,"A high-protein low-glycemic index diet attenuates gestational weight gain in pregnant women with obesity: the ""An optimized programming of healthy children"" (APPROACH) randomized controlled trial.","BACKGROUND


Prepregnancy overweight and excessive gestational weight gain (GWG) increase the risk of complications and offspring obesity.
OBJECTIVES


We aimed to investigate the effect of a high-protein low-glycemic index (HPLGI) diet on GWG, birth weight, and risk of gestational complications in pregnant women with obesity.
METHODS


A total of 279 women with prepregnancy overweight or obesity (BMI: 28-45 kg/m2), between 18 and 45 y old, and in their late first trimester with singleton pregnancies, were randomly assigned to 1 of 2 ad libitum diets: a high-protein low-glycemic index diet (HPLGI: 25%-28% of energy from protein and glycemic index ≤ 55) and a moderate-protein moderate-glycemic index diet (MPMGI: 15%-18% of energy from protein and glycemic index ∼60). Diets were consumed from gestational week 15 and throughout pregnancy. Participants received dietary guidance by a clinical dietician 9 times to facilitate adherence.
RESULTS


Out of 141 and 138 women randomly assigned to the HPLGI and MPMGI diets, 105 and 104 completed the intervention, respectively (75%). In the available case analyses, GWG was 6.8 ± 1.3 kg among women assigned the HPLGI diet and this was significantly lower, by -1.7 kg (95% CI: -2.8, -0.5 kg; P = 0.004), than the GWG of 8.5 ± 1.3 kg among women assigned the MPMGI diet. There were no significant differences between diets on major neonatal outcomes (birth weight and other anthropometric measures). The incidence of composite pregnancy complications was lower for the HPLGI than for the MPMGI diet (35.4% compared with 53.7%, respectively; P = 0.009), including cesarean delivery (15.4% compared with 28.8%, respectively; P = 0.03). There were no reported maternal, fetal, or neonatal deaths. Incidence of miscarriages (1%-2%) did not differ between groups.
CONCLUSIONS


A moderate increase in dietary protein in conjunction with a reduction in glycemic index during the last 2 trimesters of pregnancy reduced GWG and limited complications and cesarean deliveries among women with overweight or obesity.",2022,There were no significant differences between diets on major neonatal outcomes (birthweight and other anthropometric measures).,"['279 women with pre-pregnancy overweight or obesity (BMI 28-45\xa0kg/m2), between 18-45 years and in their late first trimester with singleton pregnancies', 'women with overweight or obesity', 'pregnant women with obesity', 'Out of 141 and 138 women']","['libitum diets: a high protein low glycemic index diet (HPLGI: 25-28% of energy from protein and glycemic index\xa0≤\xa055) and a moderate protein moderate glycemic index diet (MPMGI: 15-18% of energy from protein and glycemic index ∼60', 'high protein low glycemic index (HPLGI) diet', 'dietary guidance', 'protein low glycemic index diet']","['glycemic index', 'dietary protein', 'GWG, birthweight, and risk of gestational complications', 'delivery by cesarean section', 'maternal, fetal or neonatal deaths', 'incidence of composite pregnancy complications', 'Incidence of miscarriages', 'gestational weight gain', 'major neonatal outcomes (birthweight and other anthropometric measures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4517572', 'cui_str': '141'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032962', 'cui_str': 'Complication of pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",279.0,0.0816676,There were no significant differences between diets on major neonatal outcomes (birthweight and other anthropometric measures).,"[{'ForeName': 'Nina R W', 'Initials': 'NRW', 'LastName': 'Geiker', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Faidon', 'Initials': 'F', 'LastName': 'Magkos', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Zingenberg', 'Affiliation': 'Department of Obstetrics and Gynecology, Copenhagen University Hospital Herlev-Gentofte, Herlev, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Svare', 'Affiliation': 'Department of Obstetrics and Gynecology, Copenhagen University Hospital Herlev-Gentofte, Herlev, Denmark.'}, {'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Chabanova', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital Herlev-Gentofte, Herlev, Denmark.'}, {'ForeName': 'Henrik S', 'Initials': 'HS', 'LastName': 'Thomsen', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital Herlev-Gentofte, Herlev, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Frederiksberg, Denmark.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab405']
1422,34910393,"A single-arm, phase II study of niraparib and bevacizumab maintenance therapy in platinum-sensitive, recurrent ovarian cancer patients previously treated with a PARP inhibitor: Korean Gynecologic Oncology Group (KGOG 3056)/NIRVANA-R trial.","BACKGROUND


Given the expanding clinical use of poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors (PARPis), there is a significant need for optimal strategies with which to treat patients whose cancer progresses while using a PARPi. However, the treatment consensus after PARPi has not been established. The aim of the Korean Gynecologic Oncology Group (KGOG) 3056/NIRVANA-R trial is to investigate the efficacy of niraparib in combination with bevacizumab as a maintenance therapy in platinum-sensitive ovarian cancer patients who were previously treated with a PARPi.
METHODS


The KGOG 3056/NIRVANA-R is a multi-centre, investigator-initiated, single-arm, phase II trial of patients with platinum-sensitive recurrent ovarian cancer recruited from seven KGOG sites. This study included patients with platinum-sensitive recurrent epithelial ovarian cancer who received at least 2 previous courses of platinum-containing therapy and had been treated with a PARPi. Mucinous histology type was excluded. Patients who had responded to the last platinum regimen (either complete or partial response) were eligible to participate in this study. Forty-four patients will be recruited. All enrolled patients are treated with niraparib and bevacizumab for maintenance therapy until disease progression, unacceptable toxicity, or withdrawal of patient consent. The primary endpoint of the study is 6-month progression-free survival rate. Accrual is expected to be completed in 2022, followed by presentation of results in 2023.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04734665.",2022,Patients who had responded to the last platinum regimen (either complete or partial response) were eligible to participate in this study.,"['Patients who had responded to the last platinum regimen (either complete or partial response) were eligible to participate in this study', 'Forty-four patients will be recruited', 'platinum-sensitive ovarian cancer patients who were previously treated with a PARPi', 'patients with platinum-sensitive recurrent epithelial ovarian cancer who received at least 2 previous courses of platinum-containing therapy and had been treated with a PARPi', 'platinum-sensitive, recurrent ovarian cancer patients previously treated with a PARP inhibitor', 'patients with platinum-sensitive recurrent ovarian cancer recruited from seven KGOG sites']","['niraparib and bevacizumab maintenance therapy', 'niraparib and bevacizumab', 'poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors (PARPis', 'bevacizumab']",['6-month progression-free survival rate'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C2744440', 'cui_str': 'niraparib'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",44.0,0.131045,Patients who had responded to the last platinum regimen (either complete or partial response) were eligible to participate in this study.,"[{'ForeName': 'Junsik', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Myong Cheol', 'Initials': 'MC', 'LastName': 'Lim', 'Affiliation': 'Division of Tumor Immunology, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Jae-Kwan', 'Initials': 'JK', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, College of Medicine, Guro Hospital, Korea University, Seoul, Korea.'}, {'ForeName': 'Dae Hoon', 'Initials': 'DH', 'LastName': 'Jeong', 'Affiliation': 'Department of Obstetrics and Gynecology, Busan Paik Hospital, Inje University, Busan, Korea.'}, {'ForeName': 'Se Ik', 'Initials': 'SI', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Min Chul', 'Initials': 'MC', 'LastName': 'Choi', 'Affiliation': 'Comprehensive Gynecologic Cancer Center, CHA Bundang Medical Center, Seongnam, Korea.'}, {'ForeName': 'Byoung-Gie', 'Initials': 'BG', 'LastName': 'Kim', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jung-Yun', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea. jungyunlee@yuhs.ac.""}]",Journal of gynecologic oncology,['10.3802/jgo.2022.33.e12']
1423,34857585,"Protocol for a prospective double-blind, randomised, placebo-controlled feasibility trial of octreotide infusion during liver transplantation.","INTRODUCTION


Liver transplantation is a complex operation that can provide significant improvements in quality of life and survival to the recipients. However, serious complications are common and include major haemorrhage, hypotension and renal failure. Blood transfusion and the development of acute kidney injury lead to both short-term and long-term poor patient outcomes, including an increased risk of death, graft failure, length of stay and reduced quality of life. Octreotide may reduce the incidence of renal dysfunction, perioperative haemorrhage and enhance intraoperative blood pressure. However, octreotide does have risks, including resistant bradycardia, hyperglycaemia and hypoglycaemia and QT prolongation. Hence, a randomised controlled trial of octreotide during liver transplantation is needed to determine the cost-efficacy and safety of its use; this study represents a feasibility study prior to this trial.
METHODS AND ANALYSIS


We describe a multicentre, double-blind, randomised, placebo-controlled feasibility study of continuous infusion of octreotide during liver transplantation surgery. We will recruit 30 adult patients at two liver transplant centres. A blinded infusion during surgery will be administered in a 2:1 ratio of octreotide:placebo. The primary outcomes will determine the feasibility of this study design. These include the recruitment ratio, correct administration of blinded study intervention, adverse event rates, patient and clinician enrolment refusal and completion of data collection. Secondary outcome measures of efficacy and safety will help shape future trials by assessing potential primary outcome measures and monitoring safety end points. No formal statistical tests are planned. This manuscript represents study protocol number 1.3, dated 2 June 2021.
ETHICS AND DISSEMINATION


This study has received Research Ethics Committee approval. The main study outcomes will be submitted to an open-access journal.
TRIAL SPONSOR


The Joint Research Office, University College London, UK.Neither the sponsor nor the funder have any role in study design, collection, management, analysis and interpretation of data, writing of the study report or the decision to submit the report for publication.
TRIAL REGISTRATION


The study is registered with ClinicalTrials.gov (NCT04941911) with recruitment due to start in August 2021 with anticipated completion in July 2022.
CLINICAL TRIALS UNIT


Surgical and Interventional Group, Division of Surgery & Interventional Science, University College London.",2021,"Octreotide may reduce the incidence of renal dysfunction, perioperative haemorrhage and enhance intraoperative blood pressure.","['August 2021 with anticipated completion in July 2022', 'liver transplantation', 'liver transplantation surgery', '30 adult patients at two liver transplant centres']","['placebo', 'octreotide:placebo', 'Octreotide', 'octreotide']","['adverse event rates, patient and clinician enrolment refusal and completion of data collection', 'risk of death, graft failure, length of stay and reduced quality of life', 'efficacy and safety will help shape future trials by assessing potential primary outcome measures and monitoring safety end points', 'resistant bradycardia, hyperglycaemia and hypoglycaemia and QT prolongation', 'Blood transfusion', 'quality of life and survival', 'incidence of renal dysfunction, perioperative haemorrhage and enhance intraoperative blood pressure']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C4546042', 'cui_str': 'Perioperative hemorrhage'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",30.0,0.881715,"Octreotide may reduce the incidence of renal dysfunction, perioperative haemorrhage and enhance intraoperative blood pressure.","[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Fabes', 'Affiliation': 'Peninsula Medical School, University of Plymouth, Plymouth, Devon, UK jeremy.fabes@nhs.net.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Ambler', 'Affiliation': 'Department of Statistical Science, University College London, London, UK.'}, {'ForeName': 'Bina', 'Initials': 'B', 'LastName': 'Shah', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK.'}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'Peninsula Medical School, University of Plymouth, Plymouth, Devon, UK.'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Davidson', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Spiro', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2021-055864']
1424,34857578,POSNOC-POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy: a randomised controlled trial of axillary treatment in women with early-stage breast cancer who have metastases in one or two sentinel nodes.,"INTRODUCTION


ACOSOG-Z0011(Z11) trial showed that axillary node clearance (ANC) may be omitted in women with ≤2 positive nodes undergoing breast conserving surgery (BCS) and whole breast radiotherapy (RT). A confirmatory study is needed to clarify the role of axillary treatment in women with ≤2 macrometastases undergoing BCS and groups that were not included in Z11 for example, mastectomy and those with microscopic extranodal invasion. The primary objective of POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy (POSNOC) is to evaluate whether for women with breast cancer and 1 or 2 macrometastases, adjuvant therapy alone is non-inferior to adjuvant therapy plus axillary treatment, in terms of 5-year axillary recurrence.
METHODS AND ANALYSIS


POSNOC is a pragmatic, multicentre, non-inferiority, international trial with participants randomised in a 1:1 ratio. Women are eligible if they have T1/T2, unifocal or multifocal invasive breast cancer, and 1 or 2 macrometastases at sentinel node biopsy, with or without extranodal extension. In the intervention group women receive adjuvant therapy alone, in the standard care group they receive ANC or axillary RT. In both groups women receive adjuvant therapy, according to local guidelines. This includes systemic therapy and, if indicated, RT to breast or chest wall. The UK Radiotherapy Trials Quality Assurance Group manages the in-built radiotherapy quality assurance programme. Primary endpoint is 5-year axillary recurrence. Secondary outcomes are arm morbidity assessed by Lymphoedema and Breast Cancer Questionnaire and QuickDASH questionnaires; quality of life and anxiety as assessed with FACT B+4 and State/Trait Anxiety Inventory questionnaires, respectively; other oncological outcomes; economic evaluation using EQ-5D-5L. Target sample size is 1900. Primary analysis is per protocol. Recruitment started on 1 August 2014 and as of 9 June 2021, 1866 participants have been randomised.
ETHICS AND DISSEMINATION


Protocol was approved by the National Research Ethics Service Committee East Midlands-Nottingham 2 (REC reference: 13/EM/0459). Results will be submitted for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ISRCTN54765244; NCT0240168Cite Now.",2021,"The primary objective of POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy (POSNOC) is to evaluate whether for women with breast cancer and 1 or 2 macrometastases, adjuvant therapy alone is non-inferior to adjuvant therapy plus axillary treatment, in terms of 5-year axillary recurrence.
","['women with early-stage breast cancer who have metastases in one or two sentinel nodes', 'Recruitment started on 1 August 2014 and as of 9 June 2021, 1866 participants have been randomised', 'women with ≤2 positive nodes undergoing breast conserving surgery (BCS) and whole breast radiotherapy (RT', 'Women are eligible if they have T1/T2, unifocal or multifocal invasive breast cancer, and 1 or 2 macrometastases at sentinel node biopsy, with or without extranodal extension', 'women with breast cancer and 1 or 2 macrometastases', 'women with ≤2 macrometastases undergoing BCS and groups that were not included in Z11 for example, mastectomy and those with microscopic extranodal invasion']","['adjuvant therapy plus Clearance or axillary radiotherapy (POSNOC', 'adjuvant therapy plus Clearance or axillary radiotherapy', 'axillary node clearance (ANC', 'adjuvant therapy alone, in the standard care group they receive ANC or axillary RT']","['5-year axillary recurrence', 'arm morbidity assessed by Lymphoedema and Breast Cancer Questionnaire and QuickDASH questionnaires; quality of life and anxiety as assessed with FACT B+4\u2009and State/Trait Anxiety Inventory questionnaires, respectively; other oncological outcomes; economic evaluation using EQ-5D-5L. Target sample size is 1900']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0443337', 'cui_str': 'Unifocal'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3899187', 'cui_str': 'Extracapsular Extension'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0150099', 'cui_str': 'Economic Evaluation'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}]",,0.256415,"The primary objective of POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy (POSNOC) is to evaluate whether for women with breast cancer and 1 or 2 macrometastases, adjuvant therapy alone is non-inferior to adjuvant therapy plus axillary treatment, in terms of 5-year axillary recurrence.
","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Goyal', 'Affiliation': 'Department of Surgery, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK amit.goyal@nhs.net.'}, {'ForeName': 'G Bruce', 'Initials': 'GB', 'LastName': 'Mann', 'Affiliation': 'Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Fallowfield', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton & Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Lelia', 'Initials': 'L', 'LastName': 'Duley', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Reed', 'Affiliation': 'Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dodwell', 'Affiliation': 'Nuffield Department of Population Health, Oxford University, Oxford, UK.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Coleman', 'Affiliation': 'Department of Oncology and Metabolism, Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Fakis', 'Affiliation': 'Research and Development, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Newcombe', 'Affiliation': 'Department of Primary Care and Public Health, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Jenkins', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton & Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Whitham', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Childs', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Whynes', 'Affiliation': 'School of Economics, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Vaughan', 'Initials': 'V', 'LastName': 'Keeley', 'Affiliation': 'Lymphoedema Department, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ellis', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Fairbrother', 'Affiliation': ""Patient Advocate, Independent Cancer Patients' Voice, London, UK.""}, {'ForeName': 'Shabina', 'Initials': 'S', 'LastName': 'Sadiq', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Monson', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton & Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Montgomery', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Homer', 'Affiliation': 'Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Heath', 'Initials': 'H', 'LastName': 'Badger', 'Affiliation': 'Breast Cancer Trials, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Rachel Helen', 'Initials': 'RH', 'LastName': 'Haines', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Mickey', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Megias', 'Affiliation': 'National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Zohal', 'Initials': 'Z', 'LastName': 'Nabi', 'Affiliation': 'National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Preetinder', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Caraman', 'Affiliation': 'National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miles', 'Affiliation': 'National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2021-054365']
1425,34916328,"Sodium selenate as a disease-modifying treatment for progressive supranuclear palsy: protocol for a phase 2, randomised, double-blind, placebo-controlled trial.","INTRODUCTION


Progressive supranuclear palsy (PSP) is a neurodegenerative disorder for which there are currently no disease-modifying therapies. The neuropathology of PSP is associated with the accumulation of hyperphosphorylated tau in the brain. We have previously shown that protein phosphatase 2 activity in the brain is upregulated by sodium selenate, which enhances dephosphorylation. Therefore, the objective of this study is to evaluate the efficacy and safety of sodium selenate as a disease-modifying therapy for PSP.
METHODS AND ANALYSIS


This will be a multi-site, phase 2b, double-blind, placebo-controlled trial of sodium selenate. 70 patients will be recruited at six Australian academic hospitals and research institutes. Following the confirmation of eligibility at screening, participants will be randomised (1:1) to receive 52 weeks of active treatment (sodium selenate; 15 mg three times a day) or matching placebo. Regular safety and efficacy visits will be completed throughout the study period. The primary study outcome is change in an MRI volume composite (frontal lobe+midbrain-3rd ventricle) over the treatment period. Analysis will be with a general linear model (GLM) with the MRI composite at 52 weeks as the dependent variable, treatment group as an independent variable and baseline MRI composite as a covariate. Secondary outcomes are change in PSP rating scale, clinical global impression of change (clinician) and change in midbrain mean diffusivity. These outcomes will also be analysed with a GLM as above, with the corresponding baseline measure entered as a covariate. Secondary safety and tolerability outcomes are frequency of serious adverse events, frequency of down-titration occurrences and frequency of study discontinuation. Additional, as yet unplanned, exploratory outcomes will include analyses of other imaging, cognitive and biospecimen measures.
ETHICS AND DISSEMINATION


The study was approved by the Alfred Health Ethics Committee (594/20). Each participant or their legally authorised representative and their study partner will provide written informed consent at trial commencement. The results of the study will be presented at national and international conferences and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12620001254987).",2021,"Secondary outcomes are change in PSP rating scale, clinical global impression of change (clinician) and change in midbrain mean diffusivity.","['progressive supranuclear palsy', '70 patients will be recruited at six Australian academic hospitals and research institutes']","['placebo', 'sodium selenate', 'active treatment (sodium selenate; 15\u2009mg three times a day) or matching placebo', 'Sodium selenate']","['change in an MRI volume composite (frontal lobe+midbrain-3rd ventricle', 'Regular safety and efficacy visits', 'change in PSP rating scale, clinical global impression of change (clinician) and change in midbrain mean diffusivity', 'frequency of serious adverse events, frequency of down-titration occurrences and frequency of study discontinuation']","[{'cui': 'C0038868', 'cui_str': 'Progressive supranuclear palsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0035172', 'cui_str': 'Research Institutes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074765', 'cui_str': 'sodium selenate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0149555', 'cui_str': 'Third ventricle structure'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038868', 'cui_str': 'Progressive supranuclear palsy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0025462', 'cui_str': 'Midbrain structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",70.0,0.702313,"Secondary outcomes are change in PSP rating scale, clinical global impression of change (clinician) and change in midbrain mean diffusivity.","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Vivash', 'Affiliation': 'Department of Neurosciences, Monash University, Melbourne, Victoria, Australia lucy.vivash@monash.edu.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Bertram', 'Affiliation': 'Department of Neurosciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Malpas', 'Affiliation': 'Department of Neurosciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Marotta', 'Affiliation': 'Department of Neurosciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'Harding', 'Affiliation': 'Department of Neurosciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Kolbe', 'Affiliation': 'Department of Neurosciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Fielding', 'Affiliation': 'Department of Neurosciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Meaghan', 'Initials': 'M', 'LastName': 'Clough', 'Affiliation': 'Department of Neurosciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Simon J G', 'Initials': 'SJG', 'LastName': 'Lewis', 'Affiliation': ""ForeFront Parkinson's Disease Research Clinic, Brain and Mind Centre, University of Sydney, Sydney, New South Wales, Australia.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Tisch', 'Affiliation': ""Department of Neurology, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Evans', 'Affiliation': 'Department of Neurology, Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': ""O'Sullivan"", 'Affiliation': 'Centre for Clinical Research, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kimber', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Darby', 'Affiliation': 'Department of Neurosciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Law', 'Affiliation': 'Department of Neurosciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Hovens', 'Affiliation': 'Department of Surgery, Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Velakoulis', 'Affiliation': 'Department of Neuropsychiatry, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Neurosciences, Monash University, Melbourne, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2021-055019']
1426,34912869,Rationale and Design of a Pharmacist-led Intervention for the Risk-Based Prevention of Heart Failure: The FIT-HF Pilot Study.,"Background:  Given rising morbidity, mortality, and costs due to heart failure (HF), new approaches for prevention are needed. A quantitative risk-based strategy, in line with established guidelines for atherosclerotic cardiovascular disease prevention, may efficiently select patients most likely to benefit from intensification of preventive care, but a risk-based strategy has not yet been applied to HF prevention.  Methods and Results:  The Feasibility of the Implementation of Tools for Heart Failure Risk Prediction (FIT-HF) pilot study will enroll 100 participants free of cardiovascular disease who receive primary care at a single integrated health system and have a 10-year predicted risk of HF of ≥5% based on the previously validated Pooled Cohort equations to Prevent Heart Failure. All participants will complete a health and lifestyle questionnaire and undergo cardiac biomarker (B-type natriuretic peptide [BNP] and high-sensitivity cardiac troponin I [hs-cTn]) and echocardiography screening at baseline and 1-year follow-up. Participants will be randomized 1:1 to either a pharmacist-led intervention or usual care for 1 year. Participants in the intervention arm will undergo consultation with a pharmacist operating under a collaborative practice agreement with a supervising cardiologist. The pharmacist will perform lifestyle counseling and recommend initiation or intensification of therapies to optimize risk factor (hypertension, diabetes, and cholesterol) management according to the most recent clinical practice guidelines. The primary outcome is change in BNP at 1-year, and secondary and exploratory outcomes include changes in hs-cTn, risk factor levels, and cardiac mechanics at follow-up. Feasibility will be examined by monitoring retention rates.  Conclusions:  The FIT-HF pilot study will offer insight into the feasibility of a strategy of quantitative risk-based enrollment into a pharmacist-led prevention program to reduce heart failure risk.  Clinical Trial Registration:  https://clinicaltrials.gov/ct2/show/NCT04684264.",2021,The Feasibility of the Implementation of Tools for Heart Failure Risk Prediction (FIT-HF) pilot study will enroll 100 participants free of cardiovascular disease who receive primary care at a single integrated health system and have a 10-year predicted risk of HF of ≥5% based on the previously validated Pooled Cohort equations to Prevent Heart Failure.,"['100 participants free of cardiovascular disease who receive primary care at a single integrated health system and have a 10-year predicted risk of HF of ≥5% based on the previously validated Pooled Cohort equations to Prevent Heart Failure', 'All participants will complete a health and lifestyle questionnaire and undergo cardiac biomarker (B-type natriuretic peptide [BNP] and high-sensitivity cardiac troponin', 'Heart Failure']","['Pharmacist-led Intervention', 'pharmacist-led intervention or usual care for 1 year']","['change in BNP at 1-year, and secondary and exploratory outcomes include changes in hs-cTn, risk factor levels, and cardiac mechanics at follow-up']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0917591', 'cui_str': 'CTN'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",100.0,0.113414,The Feasibility of the Implementation of Tools for Heart Failure Risk Prediction (FIT-HF) pilot study will enroll 100 participants free of cardiovascular disease who receive primary care at a single integrated health system and have a 10-year predicted risk of HF of ≥5% based on the previously validated Pooled Cohort equations to Prevent Heart Failure.,"[{'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Wang', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Dolan', 'Affiliation': 'Department of Pharmacy, Northwestern Memorial Hospital, Chicago, IL, United States.'}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Freed', 'Affiliation': 'Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Vega', 'Affiliation': 'Department of Pharmacy, Northwestern Memorial Hospital, Chicago, IL, United States.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Markoski', 'Affiliation': 'Department of Pharmacy, Northwestern Memorial Hospital, Chicago, IL, United States.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Wainright', 'Affiliation': 'Department of Pharmacy, Northwestern Memorial Hospital, Chicago, IL, United States.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Kane', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Seegmiller', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Harrington', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Alana A', 'Initials': 'AA', 'LastName': 'Lewis', 'Affiliation': 'Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Clyde W', 'Initials': 'CW', 'LastName': 'Yancy', 'Affiliation': 'Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Neeland', 'Affiliation': 'Department of Medicine, University Hospitals Cleveland Medical Center, Cleveland, OH, United States.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Ning', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Lloyd-Jones', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Sadiya S', 'Initials': 'SS', 'LastName': 'Khan', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}]",Frontiers in cardiovascular medicine,['10.3389/fcvm.2021.785109']
1427,34854157,Randomized controlled pilot trial with ion-exchange water softeners to prevent eczema (SOFTER trial).,"BACKGROUND


Observational studies suggest an increased risk of eczema in children living in hard versus soft water areas, and there is, therefore, an interest in knowing whether softening water may prevent eczema. We evaluated the feasibility of a parallel-group assessor-blinded pilot randomized controlled trial to test whether installing a domestic ion-exchange water softener before birth in hard water areas reduces the risk of eczema in infants with a family history of atopy.
METHODS


Pregnant women living in hard water areas (>250 mg/L calcium carbonate) in and around London UK, were randomized 1:1 antenatally to either have an ion-exchange water softener installed in their home or not (ie to continue to receive usual domestic hard water). Infants were assessed at birth and followed up for 6 months. The main end-points were around feasibility, the primary end-point being the proportion of eligible families screened who were willing and able to be randomized. Clinical end-points were evaluated including frequency of parent-reported doctor-diagnosed eczema and visible eczema on skin examination. Descriptive analyses were conducted, and no statistical testing was performed as this was a pilot study.
RESULTS


One hundred and forty-nine families screened were eligible antenatally and 28% (41/149) could not have a water softener installed due to technical reasons or lack of landlord approval. Eighty of 149 (54%) were randomized, the primary end-point. Two participants withdrew immediately after randomization, leaving 39 participants in each arm (78 total). Attrition was 15% (12/78) by 6 months postpartum. All respondents (n = 69) to the study acceptability questionnaire reported that the study was acceptable. Fifty-six of 708 (7.9%) water samples in the water softener arm were above the hard water threshold of 20 mg/L CaCO 3  . At 6 months of age 27/67 infants (40%) developed visible eczema, 12/36 (33%) vs. 15/31 (48%) in the water softener and control groups, respectively, difference -15% (95% CI -38, 8.3%), with most assessments (≥96%) remaining blinded. Similarly, a lower proportion of infants in the water softener arm had parent-reported, doctor-diagnosed eczema by 6 months compared to the control arm, 6/17 (35%) versus 9/19 (47%), difference -12% (95% CI -44, 20%).
CONCLUSION


A randomized controlled trial of water softeners for the prevention of atopic eczema in high-risk infants is feasible and acceptable.
TRIAL REGISTRATION


NCT03270566 (clinicaltrials.gov).",2022,A randomised controlled trial of water softeners for the prevention of atopic eczema in high-risk infants is feasible and acceptable.,"['infants with a family history of atopy', 'One hundred and forty-nine families screened were eligible antenatally and 28% (41/149) could not have a water softener installed due to technical reasons or lack of landlord approval', 'children living in hard versus soft water areas', 'Eighty of 149 (54', 'Pregnant women living in hard water areas (>250 mg/L calcium carbonate) in and around London UK']","['ion-exchange water softener installed in their home or not (i.e. to continue to receive usual domestic hard water', 'installing a domestic ion-exchange water softener']","['visible eczema', 'Attrition', 'frequency of parent-reported doctor-diagnosed eczema and visible eczema on skin examination', 'doctor-diagnosed eczema', 'atopic eczema', 'risk of eczema']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C0392707', 'cui_str': 'Atopy'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0022013', 'cui_str': 'Ion exchange'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C0018599', 'cui_str': 'Hard'}]","[{'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0436149', 'cui_str': 'Examination of skin'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.24646,A randomised controlled trial of water softeners for the prevention of atopic eczema in high-risk infants is feasible and acceptable.,"[{'ForeName': 'Z K', 'Initials': 'ZK', 'LastName': 'Jabbar-Lopez', 'Affiliation': ""Unit for Population-Based Dermatology, St John's Institute of Dermatology, King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ezzamouri', 'Affiliation': ""Unit for Population-Based Dermatology, St John's Institute of Dermatology, King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Briley', 'Affiliation': ""Women's Health, King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Greenblatt', 'Affiliation': ""Unit for Population-Based Dermatology, St John's Institute of Dermatology, King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gurung', 'Affiliation': ""Unit for Population-Based Dermatology, St John's Institute of Dermatology, King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Chalmers', 'Affiliation': 'Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Thomas', 'Affiliation': 'Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Frost', 'Affiliation': 'Aqua Focus Ltd., Shrewsbury, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kezic', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'J E A', 'Initials': 'JEA', 'LastName': 'Common', 'Affiliation': 'Skin Research Institute of Singapore, A*STAR, Singapore, Singapore.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Danby', 'Affiliation': 'Department of Infection, Sheffield Dermatology Research, Immunity & Cardiovascular Diseases, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'Department of Infection, Sheffield Dermatology Research, Immunity & Cardiovascular Diseases, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Peacock', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Flohr', 'Affiliation': ""Unit for Population-Based Dermatology, St John's Institute of Dermatology, King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK.""}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.14071']
1428,34854987,Outcomes of root canal therapy or full pulpotomy using two endodontic biomaterials in mature permanent teeth: a randomized controlled trial.,"OBJECTIVE


The concept of minimally invasive endodontics recommends less-invasive vital pulp therapy (VPT) modalities over more aggressive traditional endodontic approaches in mature permanent teeth with carious pulp exposure, including irreversible pulpitis (IP) cases. Consequently, VPT needs to be compared with root canal therapy (RCT) in terms of treatment outcomes. This randomized clinical trial compares the results of full pulpotomy using two calcium-silicate cements, i.e., mineral trioxide aggregate (MTA) and calcium-enriched mixture (CEM) cement, with RCT in mature permanent teeth.
MATERIALS AND METHODS


A total of 157 carious pulp exposure cases in two academic centers with/without established IP were selected/included/randomly appointed to three study arms; (i) RCT (n = 51) as the reference treatment, (ii) pulpotomy with ProRoot MTA (PMTA; n = 55), and (iii) pulpotomy with CEM cement (PCEM; n = 51) as two alternative VPT treatments. Two-year clinical/radiographic results were the outcomes of interest. Data were statistically analyzed through the analysis of variance, chi-square, Fisher exact test, and Kruskal-Wallis.
RESULTS


At 2-year recall, 147 teeth were examined (6.4% dropout). All molars, except for one, were clinically functional/symptom-free, and there was no statistical difference between the three study arms (p = 0.653). The radiographic success rates in RCT, PMTA, and PCEM arms were 98%, 100%, and 97.9%, respectively, without statistically significant differences (p = 0.544).
CONCLUSION


In the management of mature permanent teeth with/without established IP, all experimental groups exhibited equivalent/comparable results.
CLINICAL RELEVANCE


Simple VPT using MTA/CEM can be suggested/recommended as a viable advantageous alternative to RCT for the management of carious pulp exposures with/without sign/symptoms of IP.",2022,"All molars, except for one, were clinically functional/symptom-free, and there was no statistical difference between the three study arms (p = 0.653).","['157 carious pulp exposure cases in two academic centers with/without established IP were selected/included/randomly appointed to three study arms', 'mature permanent teeth', 'mature permanent teeth with carious pulp exposure, including irreversible pulpitis (IP) cases']","['invasive vital pulp therapy (VPT) modalities', 'calcium-silicate cements, i.e., mineral trioxide aggregate (MTA) and calcium-enriched mixture (CEM) cement, with RCT', 'root canal therapy (RCT', 'root canal therapy or full pulpotomy', 'pulpotomy with ProRoot MTA (PMTA; n\u2009=\u200955), and (iii) pulpotomy with CEM cement (PCEM; n\u2009=\u200951) as two alternative VPT treatments']",['radiographic success rates'],"[{'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C1306815', 'cui_str': 'Pulp treatment'}, {'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C1098459', 'cui_str': 'aggregate ProRoot'}, {'cui': 'C4546581', 'cui_str': 'ProRoot MTA'}, {'cui': 'C4309273', 'cui_str': 'calcium-enriched mixture cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}]",157.0,0.0649448,"All molars, except for one, were clinically functional/symptom-free, and there was no statistical difference between the three study arms (p = 0.653).","[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Asgary', 'Affiliation': 'Iranian Center for Endodontic Research, Research Institute for Dental Sciences, Shahid Beheshti University of Medical Sciences, 1983963113, Tehran, Iran. saasgary@yahoo.com.'}, {'ForeName': 'Mohammad Jafar', 'Initials': 'MJ', 'LastName': 'Eghbal', 'Affiliation': 'Iranian Center for Endodontic Research, Research Institute for Dental Sciences, Shahid Beheshti University of Medical Sciences, 1983963113, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Shahravan', 'Affiliation': 'Endodontology Research Center, Endodontic Department, Dental School, Kerman University of Medical Sciences, 7618751689, Kerman, Iran.'}, {'ForeName': 'Eshaghali', 'Initials': 'E', 'LastName': 'Saberi', 'Affiliation': 'Endodontic Department, Oral and Dental Diseases Research Center, Dental School, Zahedan University of Medical Sciences, 9816743463, Zahedan, Iran.'}, {'ForeName': 'Alireza Akbarzadeh', 'Initials': 'AA', 'LastName': 'Baghban', 'Affiliation': 'Proteomics Research Center, Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, 1971653313, Tehran, Iran.'}, {'ForeName': 'Ardavan', 'Initials': 'A', 'LastName': 'Parhizkar', 'Affiliation': 'Iranian Center for Endodontic Research, Research Institute for Dental Sciences, Shahid Beheshti University of Medical Sciences, 1983963113, Tehran, Iran.'}]",Clinical oral investigations,['10.1007/s00784-021-04310-y']
1429,34997899,Cost Effectiveness of Internet-Delivered Acceptance and Commitment Therapy for Patients with Severe Health Anxiety: A Randomised Controlled Trial.,"BACKGROUND


Health anxiety is a prevalent and debilitating disorder associated with extensive use of healthcare services and reduced quality of life (QoL). Regional variability in specialised clinics or specialist healthcare providers limits access to evidence-based treatment, which may be overcome by internet-delivered Acceptance and Commitment Therapy (iACT).
OBJECTIVE


This study investigated the cost effectiveness of iACT for severe health anxiety in adults.
METHODS


Based on a Danish randomised controlled trial (March 2016-March 2017), the economic evaluation compared costs and effects between iACT and an active control condition (iFORUM). Effectiveness was measured using self-report questionnaires. The cost analysis applied a societal perspective. Resource use and healthcare costs were extracted from the Danish National Registries. Linear regression analysis was applied using change in costs/effectiveness outcomes as the dependant variable. Time, group, and interaction between time and group were independent variables. The primary outcome was the proportion of clinically significant improvements, defined as a ≥ 25% reduction in two measures of health anxiety. The probability of cost effectiveness was presented in a cost-effectiveness acceptability curve for a range of threshold values for willingness to pay.
RESULTS


No significant differences were detected in healthcare costs between groups; however, the iACT group significantly improved in all effectiveness outcomes. The economic analysis showed that, from the healthcare perspective, iACT was associated with an incremental cost-effectiveness ratio of €33 per additional case of clinically significant improvement compared with iFORUM and that, from the societal perspective, iACT dominated iFORUM because it was more effective and less expensive.
CONCLUSIONS


We found no statistically significant differences in costs between groups; however, iACT for severe health anxiety may be cost effective, as evidenced by significant differences in effect.
TRIAL REGISTRY NUMBER


Clinicaltrials.gov, no. NCT02735434.",2022,"No significant differences were detected in healthcare costs between groups; however, the iACT group significantly improved in all effectiveness outcomes.","['Patients with Severe Health Anxiety', 'severe health anxiety in adults']","['iACT', 'Internet-Delivered Acceptance and Commitment Therapy']","['healthcare costs', 'health anxiety', 'proportion of clinically significant improvements', 'Effectiveness', 'probability of cost effectiveness', 'incremental cost-effectiveness ratio', 'quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}]","[{'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0666029,"No significant differences were detected in healthcare costs between groups; however, the iACT group significantly improved in all effectiveness outcomes.","[{'ForeName': 'Bettina Wulff', 'Initials': 'BW', 'LastName': 'Risør', 'Affiliation': 'DEFACTUM, Central Denmark Region, Olof Palmes Allé 15, 8200, Aarhus N, Denmark. betris@rm.dk.'}, {'ForeName': 'Ditte Hoffmann', 'Initials': 'DH', 'LastName': 'Frydendal', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, University City 21 and 23, 8000, Aarhus C, Denmark.'}, {'ForeName': 'Marie Konge', 'Initials': 'MK', 'LastName': 'Villemoes', 'Affiliation': 'DEFACTUM, Central Denmark Region, Olof Palmes Allé 15, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Camilla Palmhøj', 'Initials': 'CP', 'LastName': 'Nielsen', 'Affiliation': 'DEFACTUM, Central Denmark Region, Olof Palmes Allé 15, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Charlotte Ulrikka', 'Initials': 'CU', 'LastName': 'Rask', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Palle Juul Jensens Boulevard 175, Entrance K, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Frostholm', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, University City 21 and 23, 8000, Aarhus C, Denmark.'}]",PharmacoEconomics - open,['10.1007/s41669-021-00319-x']
1430,34896033,"Prospective randomized trial to compare the safety, diagnostic yield and utility of 22-gauge and 19-gauge endobronchial ultrasound transbronchial needle aspirates and processing technique by cytology and histopathology.","INTRODUCTION


Endobronchial ultrasound (EBUS)-guided transbronchial needle aspirate (TBNA) is a widely used method of minimally invasive lymph node sampling. The benefit of processing samples by cytologic methods versus ""core biopsy"" is unclear. It is unknown if safety or diagnostic yield varies by needle gauge.
MATERIALS AND METHODS


Between June 2018 and July 2019, 40 patients (56 lesions) undergoing EBUS TBNA lymph node evaluation were enrolled in this single-center prospective trial. Patients were chosen by permuted block randomization to undergo EBUS TBNA starting with 22-gauge (22g) or 19-gauge (19g) needles. Separate samples were sent for processing by cytologic methods and histopathology. Surgical pathologists and cytopathologists were blinded to needle size. The primary endpoint was diagnostic yield. Secondary endpoints compared specimen adequacy by rapid onsite evaluation (ROSE), sample adequacy for molecular testing, sample quality, and safety.
RESULTS


Diagnostic yield for histopathologic examination was 87.5% and 83.9% for 19g and 22g respectively (P = 0.625). There was no significant difference in diagnostic yield by cytologic examination based on needle size. There was no significant difference in slide quality. Molecular adequacy for core-biopsy was 77% and 80% for 22g and 19g needles, respectively. Molecular adequacy for cytology cell block was 77% and 80% for 22g and 19g needles, respectively. There were no significant procedural complications.
CONCLUSION


Both the 22g and 19g EBUS TBNA needles provided a similar diagnostic yield and clinical utility for ancillary testing. Processing techniques by cytologic methods or ""core biopsy"" showed no significant impact in diagnostic yield or utility of molecular testing.",2022,"Processing techniques by cytologic methods or ""core biopsy"" showed no significant impact in diagnostic yield or utility of molecular testing.","['Between June 2018 and July 2019, 40 patients (56 lesions) undergoing EBUS TBNA lymph node evaluation']","['Endobronchial ultrasound (EBUS)-guided transbronchial needle aspirate (TBNA', '22-gauge and 19-gauge endobronchial ultrasound transbronchial needle aspirates and processing technique by cytology and histopathology']","['Molecular adequacy for cytology cell block', 'specimen adequacy by rapid onsite evaluation (ROSE), sample adequacy for molecular testing, sample quality, and safety', 'histopathologic examination', 'slide quality', 'diagnostic yield']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0370199', 'cui_str': 'Specimen obtained by aspiration'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0370199', 'cui_str': 'Specimen obtained by aspiration'}, {'cui': 'C0450404', 'cui_str': '22G'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0243140', 'cui_str': 'histopathology'}]","[{'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0677043', 'cui_str': 'Histopathology'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.16104,"Processing techniques by cytologic methods or ""core biopsy"" showed no significant impact in diagnostic yield or utility of molecular testing.","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Manley', 'Affiliation': 'Department of Pulmonary and Critical Care, Fox Chase Cancer Center, Philadelphia, Pennsylvania. Electronic address: christopher.manley@fccc.edu.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Pulmonary and Critical Care, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Yulan', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Pathology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Pathology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shuanzeng Sam', 'Initials': 'SS', 'LastName': 'Wei', 'Affiliation': 'Department of Pathology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Rajeswari', 'Initials': 'R', 'LastName': 'Nagarathinam', 'Affiliation': 'Department of Pathology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Haber', 'Affiliation': 'Department of Pulmonary and Critical Care, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Egleston', 'Affiliation': 'Biostatistics and Bioinformatics Facility, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Flieder', 'Affiliation': 'Department of Pathology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Ehya', 'Affiliation': 'Department of Pathology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}]",Journal of the American Society of Cytopathology,['10.1016/j.jasc.2021.10.003']
1431,34897593,"Treatment of Psoriasis Vulgaris with Medicated Thread Moxibustion of Zhuang Medicine: A Multicenter Randomized, Parallel Controlled Trial.","OBJECTIVE


To explore the efficacy and safety of Zhuang medicine medicated thread moxibustion (ZMTM) on psoriasis vulgaris.
METHODS


A multicenter, randomized, parallel controlled clinical trial was designed. A total of 241 outpatients with psoriasis vulgaris were randomly divided into a control group (120 cases) and a treatment group (121 cases) using a central block randomization from June 2015 to May 2018. The control group was treated with Western medicines alone including pidotimod dispersible tablets, vitamin B compound tablets, and compound cod liver oil-zinc oxide ointment. The treatment group was treated with ZMTM every 2 days combined with Western medicines. The two groups received continuous intervention for 30 days. The primary outcome was Psoriasis Area and Severity Index (PASI), and the secondary outcomes included Itch Rating Scale, Dermatology Quality of Life Index (DLQI), Hamilton Anxiety Rating Scale (HAMA), as well as PASI response rate. Meanwhile, adverse events were evaluated during the whole clinical trial. Follow-up was carried out 30 days after treatment.
RESULTS


There were 5 cases of shedding in this trial. In intention-to-treat analysis, 236 cases were included and each group contained 118 cases. On the 30th and 60th days, PASI scores of patients in each group were significantly lower than that at baseline (P<0.01) and the PASI score reduction of the treatment group was greater than that of the control group (P<0.01). Itch Rating Scale, DLQI, and HAMA scale were decreased in both groups after treatment, and the treatment group showed a better therapeutic effect (P<0.01). The response rates of PASI 50 and 75 were significantly higher than those in the control group [81.4% (96/118), 43.2% (51/118) vs. 41.5% (49/118), 11.0% (13/118), respectively, P<0.05]. During follow-up, the improvements in scores of PASI, Itch Rating Scale, DLQI, and HAMA of the treatment group were significantly greater than those of the control group (P<0.01). The response rates of PASI 50 and 75 in the treatment group were significantly higher than those in the control group, respectively (both P<0.05). No obvious adverse reaction was found in either group.
CONCLUSION


ZMTM combined with Western medicines showed a better therapeutic effect in the treatment of psoriasis vulgaris without obvious adverse reaction. (Trial Registration No. ChiCTR-IOR-16008159).",2022,"The response rates of PASI 50 and 75 in the treatment group were significantly higher than those in the control group, respectively (both P<0.05).","['Psoriasis Vulgaris with Medicated Thread Moxibustion of Zhuang Medicine', '241 outpatients with psoriasis vulgaris']","['continuous intervention', 'ZMTM every 2 days combined with Western medicines', 'ZMTM combined with Western medicines', 'Zhuang medicine medicated thread moxibustion (ZMTM', 'Western medicines alone including pidotimod dispersible tablets, vitamin B compound tablets, and compound cod liver oil-zinc oxide ointment']","['scores of PASI, Itch Rating Scale, DLQI, and HAMA', 'PASI score reduction', 'efficacy and safety', 'Psoriasis Area and Severity Index (PASI), and the secondary outcomes included Itch Rating Scale, Dermatology Quality of Life Index (DLQI), Hamilton Anxiety Rating Scale (HAMA), as well as PASI response rate', 'PASI scores', 'Meanwhile, adverse events', 'Itch Rating Scale, DLQI, and HAMA scale', 'response rates of PASI', 'obvious adverse reaction']","[{'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0574665', 'cui_str': 'Chuang language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0574665', 'cui_str': 'Chuang language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0081002', 'cui_str': 'pidotimod'}, {'cui': 'C0991504', 'cui_str': 'Disintegrating Oral Tablet'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0009213', 'cui_str': 'Cod Liver Oil'}, {'cui': 'C1248556', 'cui_str': 'Zinc Oxide Topical Ointment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",241.0,0.0409247,"The response rates of PASI 50 and 75 in the treatment group were significantly higher than those in the control group, respectively (both P<0.05).","[{'ForeName': 'Yu-Zhou', 'Initials': 'YZ', 'LastName': 'Pang', 'Affiliation': 'School of Zhuang Medicine, Guangxi University of Chinese Medicine, Nanning, 530001, China. 2017pangyuzhou@sina.com.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Zhuang Medicine Acupuncture, Guangxi International Hospital of Zhuang Medicine Affiliated to Guangxi University of Chinese Medicine, Nanning, 530201, China.'}, {'ForeName': 'Qing-Huai', 'Initials': 'QH', 'LastName': 'Zhang', 'Affiliation': 'School of Zhuang Medicine, Guangxi University of Chinese Medicine, Nanning, 530001, China.'}, {'ForeName': 'Feng-Zhen', 'Initials': 'FZ', 'LastName': 'Liang', 'Affiliation': 'Graduate School of Guangxi University of Chinese Medicine, Nanning, 530001, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Fang', 'Affiliation': 'School of Zhuang Medicine, Guangxi University of Chinese Medicine, Nanning, 530001, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, 999077, China.'}, {'ForeName': 'Hong-Cai', 'Initials': 'HC', 'LastName': 'Shang', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Beijing University of Chinese Medicine, Beijing, 100000, China.'}, {'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Wang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China. wangyanping4816@163.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-021-3489-5']
1432,34000716,Characteristics and Endoscopic Classification of Ulcerative Lesions Affecting the Ileocecal Valve.,"OBJECTIVES


The aim of this study was to propose an endoscopic classification system for ulcerative lesions on the ileocecal valve and investigate its relevance to the underlying etiology.
METHODS


Among the 60,325 patients who underwent colonoscopy at our hospital from January 2006 to December 2018, patients with ulcerative lesions on the ileocecal valve were included. The following data were obtained using the hospital's medical records: sex, age, clinical diagnosis, laboratory data, and endoscopic and histological findings. Patients who have ulcerative colitis and who were not evaluated by histological examination were excluded. Ulcerative lesions on the ileocecal valve were classified into 3 groups according to their endoscopic appearance: small shallow ulcerative lesions without edematous change (group A), lateral spreading shallow ulcerative lesions with edematous change (group B), and deep deformed ulcerative lesions (group C). The association between this endoscopic classification and its clinical diagnosis, clinical course, and the interobserver reliability were evaluated.
RESULTS


Of 72 patients who were eligible for analysis, 18 were assigned to group A, 9 to group B, and 45 to group C. Infectious enteritis was mainly assigned to group A (group A, 12; group B, none; and group C, 6; p < 0.0001), inflammatory bowel disease was mainly assigned to group C (group A, none; group B, 5; and group C, 35; p < 0.0001), and malignant tumor was assigned to group C only. Interobserver reliability was extremely high among the 3 examining doctors (kappa value 0.7-0.8).
CONCLUSION


Endoscopic classification was divided into 3 groups for ulcerative lesions on the ileocecal valve, and this system could be beneficial for presuming their clinical diagnoses.",2022,"Ulcerative lesions on the ileocecal valve were classified into 3 groups according to their endoscopic appearance: small shallow ulcerative lesions without edematous change (group A), lateral spreading shallow ulcerative lesions with edematous change (group B), and deep deformed ulcerative lesions (group C).","['Patients who have ulcerative colitis and who were not evaluated by histological examination were excluded', '72 patients who were eligible for analysis', 'Ulcerative lesions on the ileocecal valve were classified into 3 groups according to their endoscopic appearance: small shallow ulcerative lesions without edematous change (group A), lateral spreading shallow ulcerative lesions with edematous change (group B), and deep deformed ulcerative lesions (group C', '60,325 patients who underwent colonoscopy at our hospital from January 2006 to December 2018, patients with ulcerative lesions on the ileocecal valve were included']",[],"['Interobserver reliability', 'inflammatory bowel disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0020880', 'cui_str': 'Ileocecal valve structure'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}]",60325.0,0.0159309,"Ulcerative lesions on the ileocecal valve were classified into 3 groups according to their endoscopic appearance: small shallow ulcerative lesions without edematous change (group A), lateral spreading shallow ulcerative lesions with edematous change (group B), and deep deformed ulcerative lesions (group C).","[{'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Miyazaki', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Sakurai', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Iwashita', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Shimada', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Shibuya', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Akita', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Haruna', 'Initials': 'H', 'LastName': 'Miyashita', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Maruyama', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Sawada', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Toyonaga', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Takakura', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Saruta', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}]","Digestive diseases (Basel, Switzerland)",['10.1159/000516975']
1433,34905220,"Mechanistic Modeling of Primaquine Pharmacokinetics, Gametocytocidal Activity, and Mosquito Infectivity.","Clinical studies have shown that adding a single 0.25 mg base/kg dose of primaquine to standard antimalarial regimens rapidly sterilizes Plasmodium falciparum gametocytes. However, the mechanism of action and overall impact on malaria transmission is still unknown. Using data from 81 adult Malians with P. falciparum gametocytemia who received the standard dihydroartemisinin-piperaquine treatment course and were randomized to receive either a single dose of primaquine between 0.0625 and 0.5 mg base/kg or placebo, we characterized the pharmacokinetic-pharmacodynamic relationships for transmission blocking activity. Both gametocyte clearance and mosquito infectivity were assessed. A mechanistically linked pharmacokinetic-pharmacodynamic model adequately described primaquine and carboxy-primaquine pharmacokinetics, gametocyte dynamics, and mosquito infectivity at different clinical doses of primaquine. Primaquine showed a dose-dependent gametocytocidal effect that precedes clearance. A single low dose of primaquine (0.25 mg/kg) rapidly prevented P. falciparum transmissibility.",2022,A single low dose of primaquine (0.25 mg/kg) rapidly prevented P. falciparum transmissibility.,['81 adult Malians with P.\xa0falciparum gametocytemia who received the standard dihydroartemisinin-piperaquine treatment course'],"['primaquine', 'primaquine between 0.0625 and 0.5\xa0mg base/kg or placebo', 'Primaquine']",['gametocyte clearance and mosquito infectivity'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0686869', 'cui_str': 'Kingdom Protozoa gametocyte'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0026584', 'cui_str': 'Family Culicidae'}, {'cui': 'C0030657', 'cui_str': 'pathogenicity'}]",81.0,0.0895634,A single low dose of primaquine (0.25 mg/kg) rapidly prevented P. falciparum transmissibility.,"[{'ForeName': 'Palang', 'Initials': 'P', 'LastName': 'Chotsiri', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Almahamoudou', 'Initials': 'A', 'LastName': 'Mahamar', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Hoglund', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Fanta', 'Initials': 'F', 'LastName': 'Koita', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Koualy', 'Initials': 'K', 'LastName': 'Sanogo', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Halimatou', 'Initials': 'H', 'LastName': 'Diawara', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Simpson', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'Bousema', 'Affiliation': 'Radboud Institute of Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Joelle M', 'Initials': 'JM', 'LastName': 'Brown', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, California, USA.'}, {'ForeName': 'Roly', 'Initials': 'R', 'LastName': 'Gosling', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, California, USA.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Chen', 'Affiliation': 'Global Health Group, Malaria Elimination Initiative, University of California, San Francisco, California, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Tarning', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2512']
1434,34902262,Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial.,"The objective of this study was to investigate the efficacy and safety of early treatment with sarilumab, added to standard of care (SOC), in hospitalized adults with COVID-19. Methods included phase II, open-label, randomized, controlled clinical trial of hospitalized patients with COVID-19 pneumonia and interleukin (IL)-6 levels ≥ 40 pg/mL and/or d-dimer > 1,500 ng/mL. Participants were randomized (1:1:1) to receive SOC (control group), SOC plus a single subcutaneous dose of sarilumab 200 mg (sarilumab-200 group), or SOC plus a single subcutaneous dose of sarilumab 400 mg (sarilumab-400 group). The primary outcome variable was the development of acute respiratory distress syndrome (ARDS) requiring high-flow nasal oxygenation (HFNO), non-invasive mechanical ventilation (NIMV) or invasive mechanical ventilation (IMV) at day 28. One-hundred and 15 participants (control group,  n  = 39; sarilumab-200,  n  = 37; sarilumab-400,  n  = 39) were included. At randomization, 104 (90%) patients had supplemental oxygen and 103 (90%) received corticosteroids. Eleven (28%) patients in the control group, 10 (27%) in sarilumab-200, and five (13%) in sarilumab-400 developed the primary outcome (hazard ratio [95% CI] of sarilumab-400 vs control group: 0.41 [0.14, 1.18];  P  = 0.09). Seven (6%) patients died: three in the control group and four in sarilumab-200. There were no deaths in sarilumab-400 ( P  = 0.079, log-rank test for comparisons with the control group). In patients recently hospitalized with COVID-19 pneumonia and features of systemic inflammation, early IL-6 blockade with a single dose of sarilumab 400 mg was safe and associated with a trend for better outcomes. (This study has been registered at ClinicalTrials.gov under identifier NCT04357860.).",2022,(IL)-6 levels ≥ 40 pg/mL,"['hospitalised adults with COVID-19', '115 patients hospitalized with COVID-19 and systemic inflammation, early use of sarilumab was associated with a low risk of acute respiratory distress syndrome requiring high-flow devices or mechanical ventilation', 'Patients Hospitalised with COVID-19 Pneumonia and Features of Systemic Inflammation', 'One-hundred and fifteen participants (control group, n = 39; Sarilumab-200, n = 37; Sarilumab-400, n = 39) were included', 'hospitalised patients with COVID-19 pneumonia and interleukin']","['sarilumab, added to standard of care (SOC', 'SOC (control group), SOC plus a single subcutaneous dose of sarilumab 200 mg (Sarilumab-200) or SOC plus a single subcutaneous dose of sarilumab 400 mg (Sarilumab-400', 'corticosteroids', 'Sarilumab']","['development of acute respiratory distress syndrome (ARDS) requiring high-flow nasal oxygenation (HFNO), non-invasive mechanical ventilation (NIMV) or invasive mechanical ventilation (IMV', 'efficacy and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}]","[{'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",115.0,0.318849,(IL)-6 levels ≥ 40 pg/mL,"[{'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Merchante', 'Affiliation': 'Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valmegrid.412800.f, Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Sevilla, Spain.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Cárcel', 'Affiliation': 'Unidad de Gestión Clínica de Cuidados Intensivos, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía, Universidad de Córdoba (UCO), Córdoba, Spain.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Garrido-Gracia', 'Affiliation': 'Unidad de Ensayos Clínicos, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía, Universidad de Córdoba (UCO), Córdoba, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Trigo-Rodríguez', 'Affiliation': 'Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valmegrid.412800.f, Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Sevilla, Spain.'}, {'ForeName': 'María Ángeles Esteban', 'Initials': 'MÁE', 'LastName': 'Moreno', 'Affiliation': 'Servicio de Medicina Interna, Hospital Universitario Torrecárdenas, Almería, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'León-López', 'Affiliation': 'Unidad de Gestión Clínica de Cuidados Intensivos, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía, Universidad de Córdoba (UCO), Córdoba, Spain.'}, {'ForeName': 'Reinaldo', 'Initials': 'R', 'LastName': 'Espíndola-Gómez', 'Affiliation': 'Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valmegrid.412800.f, Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Sevilla, Spain.'}, {'ForeName': 'Eduardo Aguilar', 'Initials': 'EA', 'LastName': 'Alonso', 'Affiliation': 'Servicio de Medicina Intensiva, Hospital Infanta Margarita, Córdoba, Spain.'}, {'ForeName': 'David Vinuesa', 'Initials': 'DV', 'LastName': 'García', 'Affiliation': 'Unidad de Gestión Clínica de Enfermedades Infecciosas, Hospital Universitario Clínico San Cecilio, Granada, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Romero-Palacios', 'Affiliation': 'Unidad de Enfermedades Infecciosas, Hospital Universitario Puerto Real, Instituto de Investigacion Biomédica de Cádiz (INiBICA), Cádiz, Spain.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Pérez-Camacho', 'Affiliation': 'Unidad de Gestión Clínica de Enfermedades Infecciosas, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Gutiérrez-Gutiérrez', 'Affiliation': 'Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospital Universitario Virgen Macarena, Instituto de Biomedicina de Sevilla (IBIS), Universidad de Sevilla, Sevilla, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Martínez-Marcos', 'Affiliation': 'Unidad de Enfermedades Infecciosas, Hospital Universitario Juan Ramón Jiménez, Huelva, Spain.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Fernández-Roldán', 'Affiliation': 'Unidad de Enfermedades Infecciosas, Hospital Universitario Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Pedro María Martínez', 'Initials': 'PMM', 'LastName': 'Pérez-Crespo', 'Affiliation': 'Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valmegrid.412800.f, Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Sevilla, Spain.'}, {'ForeName': 'Alexandra Aceituno', 'Initials': 'AA', 'LastName': 'Caño', 'Affiliation': 'Servicio de Medicina Interna, Hospital Universitario Torrecárdenas, Almería, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'León', 'Affiliation': 'Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valmegrid.412800.f, Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Sevilla, Spain.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'Corzo', 'Affiliation': 'Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valmegrid.412800.f, Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Sevilla, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'de la Fuente', 'Affiliation': 'Unidad de Gestión Clínica de Cuidados Intensivos, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía, Universidad de Córdoba (UCO), Córdoba, Spain.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Torre-Cisneros', 'Affiliation': 'Servicio de Enfermedades Infecciosas, Hospital Universitario Reina Sofía, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Universidad de Córdoba (UCO), Córdoba, Spain.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02107-21']
1435,34911710,Two-step versus 1-step subretinal injection to compare subretinal drug delivery: a randomised study protocol.,"INTRODUCTION


There is increasing interest in subretinal injections as a surgical procedure, largely as a result of emerging treatments for ocular diseases which necessitate this manoeuvre. However, surgical variables in the efficacy of such treatments have to date been largely overlooked and the proportion of drug which reaches the intended compartment of the subretinal space remains unknown. Our aims are twofold: first, to determine the proportion of subretinally injected medication retained following surgical delivery and second, to compare two different techniques of injection ('1-step' vs '2-step').
METHODS


We outline a randomised controlled trial of subretinal injection of alteplase following vitrectomy for the management of submacular haemorrhage secondary to age-related macular degeneration. Patients will be randomised to receive either 1-step injection, where the therapeutic solution simultaneously defines the surgical plane or 2-step injection, where the surgical plane is first identified with balanced salt solution prior to injection of subretinal alteplase, as outlined below. Sodium fluorescein will be used as an optical label to track drug reflux into the vitreous cavity using quantitative protocols established in our laboratory. All patients will undergo fluid air exchange at the completion of surgery, with injection of bevacizumab 1.25 mg and 20% sulfahexafluoride gas as the vitreous substitute (both of which may help improve outcomes). Alteplase, sodium fluorescein and bevacizumab will all be used for off-label indications in the trial.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from the South Eastern Sydney Local Health District's Human Research Ethics Committee (HREC 17/092). The results of this trial will be disseminated in peer-reviewed proceedings (associated with conference presentation) and in scholarly journals.
TRIAL REGISTRATION NUMBER


ACTRN12619001121156.",2021,Ethical approval has been obtained from the South Eastern Sydney Local Health District's Human Research Ethics Committee (HREC 17/092).,['submacular haemorrhage secondary to age-related macular degeneration'],"['alteplase following vitrectomy', 'Alteplase, sodium fluorescein and bevacizumab', 'bevacizumab 1.25 mg and 20% sulfahexafluoride gas', 'Sodium fluorescein']",[],"[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0024437', 'cui_str': 'Degenerative disorder of macula'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0147866', 'cui_str': 'Fluorescein sodium stain'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0017110', 'cui_str': 'Gas'}]",[],,0.0786955,Ethical approval has been obtained from the South Eastern Sydney Local Health District's Human Research Ethics Committee (HREC 17/092).,"[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Simunovic', 'Affiliation': 'Save Sight Institute, University of Sydney, Sydney, New South Wales, Australia matthew.simunovic@sydney.edu.au.'}, {'ForeName': 'Emily H', 'Initials': 'EH', 'LastName': 'Shao', 'Affiliation': 'Retinal Unit, Sydney Eye Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Perach', 'Initials': 'P', 'LastName': 'Osaadon', 'Affiliation': 'Retinal Unit, Sydney Eye Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Muhammad Bayu', 'Initials': 'MB', 'LastName': 'Sasongko', 'Affiliation': 'Retinal Unit, Sydney Eye Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lay Khoon', 'Initials': 'LK', 'LastName': 'Too', 'Affiliation': 'Save Sight Institute, University of Sydney, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2021-049976']
1436,34895296,Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): protocol for identification of novel biomarkers via neurophysiology.,"BACKGROUND


Electroconvulsive therapy (ECT) is the most effective treatment for treatment-resistant depression (TRD), especially for acute suicidal ideation, but the associated cognitive adverse effects and negative stigma limit its use. Another seizure therapy under development is magnetic seizure therapy (MST), which could potentially overcome the restrictions associated with ECT with similar efficacy. The neurophysiological targets and mechanisms of seizure therapy, however, remain poorly understood.
METHODS/DESIGN


This neurophysiological study protocol is published as a companion to the overall Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST) protocol that describes our two-site, double-blind, randomized, non-inferiority clinical trial to develop MST as an effective and safe treatment for TRD. Our aim for the neurophysiological component of the study is to evaluate two biomarkers, one to predict remission of suicidal ideation (primary outcome) and the other to predict cognitive impairment (secondary outcome). Suicidal ideation will be assessed through cortical inhibition, which according to our preliminary studies, correlates with remission of suicidal ideation. Cortical inhibition will be measured with simultaneous transcranial magnetic stimulation (TMS) and electroencephalography (EEG), TMS-EEG, which measures TMS-evoked EEG activity. Cognitive adverse effects associated with seizure therapy, on the contrary, will be evaluated via multiscale entropy analysis reflecting the complexity of ongoing resting-state EEG activity.
DISCUSSION


ECT and MST are known to influence cortical inhibition associated with depression, suicidal ideation severity, and clinical outcome. Therefore, evaluating cortical inhibition and brain temporal dynamics will help understand the pathophysiology of depression and suicidal ideation and define new biological targets that could aid clinicians in diagnosing and selecting treatments. Resting-state EEG complexity was previously associated with the degree of cognitive side effects after a seizure therapy. This neurophysiological metric may help clinicians assess the risk for adverse effects caused by these useful and effective treatments.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03191058 . Registered on June 19, 2017.",2021,"Suicidal ideation will be assessed through cortical inhibition, which according to our preliminary studies, correlates with remission of suicidal ideation.",['Depression'],"['Electroconvulsive therapy (ECT', 'magnetic seizure therapy (MST', 'Magnetic Seizure Therapy', 'MST']","['simultaneous transcranial magnetic stimulation (TMS) and electroencephalography (EEG), TMS-EEG, which measures TMS-evoked EEG activity', 'Suicidal ideation']","[{'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",,0.202517,"Suicidal ideation will be assessed through cortical inhibition, which according to our preliminary studies, correlates with remission of suicidal ideation.","[{'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, USA. zdaskalakis@health.ucsd.edu.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Itay', 'Initials': 'I', 'LastName': 'Hadas', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Kallioniemi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Zomorrodi', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Alanah', 'Initials': 'A', 'LastName': 'Throop', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Palmer', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Faranak', 'Initials': 'F', 'LastName': 'Farzan', 'Affiliation': 'School of Mechatronic Systems Engineering, Simon Fraser University, Surrey, British Columbia, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's, Toronto, Ontario, Canada.""}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Tamminga', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}]",Trials,['10.1186/s13063-021-05873-7']
1437,34907082,Functional Mapping of AKT Signaling and Biomarkers of Response from the FAIRLANE Trial of Neoadjuvant Ipatasertib plus Paclitaxel for Triple-Negative Breast Cancer.,"PURPOSE


Despite extensive genomic and transcriptomic profiling, it remains unknown how signaling pathways are differentially activated and how tumors are differentially sensitized to certain perturbations. Here, we aim to characterize AKT signaling activity and its association with other genomic or IHC-based PI3K/AKT pathway biomarkers as well as the clinical activity of ipatasertib (AKT inhibitor) in the FAIRLANE trial.
EXPERIMENTAL DESIGN


In FAIRLANE, 151 patients with early triple-negative breast cancer (TNBC) were randomized 1:1 to receive paclitaxel with ipatasertib or placebo for 12 weeks prior to surgery. Adding ipatasertib did not increase pathologic complete response rate and numerically improved overall response rate by MRI. We used reverse-phase protein microarrays (RPPA) to examine the total level and/or phosphorylation states of over 100 proteins in various signaling or cell processes including PI3K/AKT and mTOR signaling. One hundred and twenty-five baseline and 127 on-treatment samples were evaluable by RPPA, with 110 paired samples at both time points.
RESULTS


Tumors with genomic/protein alterations in PIK3CA/AKT1/PTEN were associated with higher levels of AKT phosphorylation. In addition, phosphorylated AKT (pAKT) levels exhibited a significant association with enriched clinical benefit of ipatasertib, and identified patients who received benefit in the absence of PIK3CA/AKT1/PTEN alterations. Ipatasertib treatment led to a downregulation of AKT/mTORC1 signaling, which was more pronounced among the tumors with PIK3CA/AKT1/PTEN alterations or among the responders to the treatment.
CONCLUSIONS


We showed that the high baseline pAKT levels are associated with the alterations of PI3K/AKT pathway components and enriched benefit of ipatasertib in TNBC.",2022,"Ipatasertib treatment led to a downregulation of AKT/mTORC1 signaling, which was more pronounced among the tumors with PIK3CA/AKT1/PTEN alterations or among the responders to the treatment.
","['One hundred and twenty-five baseline and 127 on-treatment samples were evaluable by RPPA, with 110 paired samples at both time points', 'Triple-Negative Breast Cancer', '151 patients with early triple-negative breast cancer (TNBC']","['paclitaxel with ipatasertib or placebo', 'Neoadjuvant Ipatasertib plus Paclitaxel']","['pathologic complete response rate', 'overall response rate']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1136348', 'cui_str': 'Protein Chips'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C3712838', 'cui_str': '2-(4-chlorophenyl)-1-(4-(7-hydroxy-5-methyl-6,7-dihydro-5H-cyclopenta(d)pyrimidin-4-yl)piperazin-1-yl)-3-(isopropylamino)propan-1-one'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",151.0,0.145126,"Ipatasertib treatment led to a downregulation of AKT/mTORC1 signaling, which was more pronounced among the tumors with PIK3CA/AKT1/PTEN alterations or among the responders to the treatment.
","[{'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Department of Oncology Biomarker, Genentech Inc., South San Francisco, California.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wulfkuhle', 'Affiliation': 'Center for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, Virginia.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Nowicka', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Rosa I', 'Initials': 'RI', 'LastName': 'Gallagher', 'Affiliation': 'Center for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, Virginia.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Paolo G', 'Initials': 'PG', 'LastName': 'Nuciforo', 'Affiliation': ""Molecular Oncology Group, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Calvo', 'Affiliation': 'Breast Cancer Unit, Centro Integral Oncologico Clara Campal (CIOCC), Madrid, Spain.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Andersen', 'Affiliation': 'Medical Oncology/Hematology, Compass Oncology, Tigard, Oregon.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Passos-Coelho', 'Affiliation': 'Oncology Department, Hospital Beatriz Angelo, Loures, Portugal.'}, {'ForeName': 'Miguel J', 'Initials': 'MJ', 'LastName': 'Gil-Gil', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Bermejo', 'Affiliation': 'Hospital Clinico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Pratt', 'Affiliation': 'Texas Oncology Cancer Center, US Oncology, Austin, Texas.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Ciruelos', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Villagrasa', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Wongchenko', 'Affiliation': 'Department of Oncology Biomarker, Genentech Inc., South San Francisco, California.'}, {'ForeName': 'Emanuel F', 'Initials': 'EF', 'LastName': 'Petricoin', 'Affiliation': 'Center for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, Virginia.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Isakoff', 'Affiliation': 'Division of Hematology/Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-2498']
1438,34900203,"Efficacy of Whole-Body Vibration Training on Brain-Derived Neurotrophic Factor, Clinical and Functional Outcomes, and Quality of Life in Women with Fibromyalgia Syndrome: A Randomized Controlled Trial.","This study aimed to investigate the efficacy of whole-body vibration training (WBVT) on blood brain-derived neurotrophic factor (BDNF) levels and determine the clinical and functional outcomes in patients with fibromyalgia syndrome (FMS). Thirty-two women with FMS were randomized into an intervention group (IG), receiving 6 weeks of WBVT, or a control group (CG) with no intervention. The outcomes at the baseline and follow-up in both groups included blood BDNF levels, sit-to-stand test (STS), 6-minute walk test (6MWT), Fibromyalgia Impact Questionnaire (FIQ), Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory (BDI), and visual analogue scale (VAS). WBVT resulted in a group-by-time interaction effect. Thus, after the intervention time, the IG had increased blood BDNF levels ( p =0.045), a higher number of repetitions on the STS test ( p =0.011), and increased walking distance on the 6MWT ( p =0.010), compared to CG. Moreover, there was a reduction in the scores of the FIQ ( p =0.001), the PSQI ( p =0.001), the BDI ( p =0.017), and pain assessed using VAS ( p =0.008) in IG. The results demonstrate that WBVT promotes an increase in blood BDNF levels, with concomitant improvement in lower limb muscle strength, aerobic capacity, clinical symptoms, and quality of life in women with FMS. This trial is registered with Brazilian Clinical Trials Registry (REBEC; RBR-38nbbx) (https://ensaiosclinicos.gov.br/rg/RBR-38nbbx).",2021,"Moreover, there was a reduction in the scores of the FIQ ( p =0.001), the PSQI ( p =0.001), the BDI ( p =0.017), and pain assessed using VAS ( p =0.008) in IG.","['patients with fibromyalgia syndrome (FMS', 'Thirty-two women with FMS', 'women with FMS', 'Women with Fibromyalgia Syndrome']","['whole-body vibration training (WBVT', 'intervention group (IG), receiving 6 weeks of WBVT, or a control group (CG) with no intervention', 'Whole-Body Vibration Training', 'WBVT']","['lower limb muscle strength, aerobic capacity, clinical symptoms, and quality of life', 'blood BDNF levels', 'higher number of repetitions on the STS test', 'blood BDNF levels, sit-to-stand test (STS), 6-minute walk test (6MWT), Fibromyalgia Impact Questionnaire (FIQ), Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory (BDI), and visual analogue scale (VAS', 'scores of the FIQ', 'blood brain-derived neurotrophic factor (BDNF) levels', 'PSQI', 'BDI', 'walking distance', 'pain assessed using VAS', 'Brain-Derived Neurotrophic Factor, Clinical and Functional Outcomes, and Quality of Life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",32.0,0.0433087,"Moreover, there was a reduction in the scores of the FIQ ( p =0.001), the PSQI ( p =0.001), the BDI ( p =0.017), and pain assessed using VAS ( p =0.008) in IG.","[{'ForeName': 'Vanessa G C', 'Initials': 'VGC', 'LastName': 'Ribeiro', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Ana C R', 'Initials': 'ACR', 'LastName': 'Lacerda', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Jousielle M', 'Initials': 'JM', 'LastName': 'Santos', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Coelho-Oliveira', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Sueli F', 'Initials': 'SF', 'LastName': 'Fonseca', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Ana C N', 'Initials': 'ACN', 'LastName': 'Prates', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Jurandir', 'Initials': 'J', 'LastName': 'Flor', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Bruna C C', 'Initials': 'BCC', 'LastName': 'Garcia', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Rosalina', 'Initials': 'R', 'LastName': 'Tossige-Gomes', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Hércules R', 'Initials': 'HR', 'LastName': 'Leite', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'José S C', 'Initials': 'JSC', 'LastName': 'Fernandes', 'Affiliation': 'Faculty of Agrarian Sciences, Federal University of the Jequitinhonha and Mucuri Valleys, Diamantina, MG, Brazil.'}, {'ForeName': 'Arthur N', 'Initials': 'AN', 'LastName': 'Arrieiro', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sartorio', 'Affiliation': 'Istituto Auxologico Italiano, Division of Metabolic Diseases and Auxology & Experimental Laboratory for Auxo-endocrinological Research, Verbania, Italy.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Sañudo', 'Affiliation': 'Department of Physical Education and Sport, University of Seville, Seville 41013, Spain.'}, {'ForeName': 'Danubia C', 'Initials': 'DC', 'LastName': 'Sá-Caputo', 'Affiliation': 'Mechanical Vibration Laboratory and Integrative Practices (LAVIMPI), Biophysics and Biometrics Department, Institute of Biology Roberto Alcântara Gomes and Piquet Carneiro Polyclinic, Rio de Janeiro State University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mário', 'Initials': 'M', 'LastName': 'Bernardo-Filho', 'Affiliation': 'Mechanical Vibration Laboratory and Integrative Practices (LAVIMPI), Biophysics and Biometrics Department, Institute of Biology Roberto Alcântara Gomes and Piquet Carneiro Polyclinic, Rio de Janeiro State University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Pedro H S', 'Initials': 'PHS', 'LastName': 'Figueiredo', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Henrique S', 'Initials': 'HS', 'LastName': 'Costa', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Vanessa P', 'Initials': 'VP', 'LastName': 'Lima', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Renato F', 'Initials': 'RF', 'LastName': 'Cardoso', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Alessandra C', 'Initials': 'AC', 'LastName': 'Bastone', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Luana A', 'Initials': 'LA', 'LastName': 'Soares', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'Mendonça', 'Affiliation': 'Integrated Center for Research and Post-Graduate Studies in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Redha', 'Initials': 'R', 'LastName': 'Taiar', 'Affiliation': 'MATériaux et Ingénierie Mécanique (MATIM), Université de Reims Champagne-Ardenne, Reims, France.'}]",Journal of healthcare engineering,['10.1155/2021/7593802']
1439,34911731,Controlled Study of Decision-Making Algorithms for Kidney Replacement Therapy Initiation in Acute Kidney Injury.,"BACKGROUND AND OBJECTIVES


AKI requiring KRT is associated with high mortality and utilization. We evaluated the use of an AKI Standardized Clinical Assessment and Management Plan (SCAMP) on patient outcomes, including mortality, hospital length of stay, and intensive care unit length of stay.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


We conducted a 12-month controlled study in the intensive care units of a large academic tertiary medical center. We alternated use of the AKI-SCAMP with use of a ""sham"" control form in 4- to 6-week blocks. The primary outcome was risk of inpatient mortality. Prespecified secondary outcomes included 30- and 60-day mortality, hospital length of stay, and intensive care unit length of stay. Generalized estimating equations were used to estimate the effect of the AKI-SCAMP on mortality and length of stay.
RESULTS


There were 122 patients in the AKI-SCAMP group and 102 patients in the control group. There was no significant difference in inpatient mortality associated with AKI-SCAMP use (41% versus 47% control). AKI-SCAMP use was associated with significantly reduced intensive care unit length of stay (mean, 8; 95% confidence interval, 8 to 9 days versus mean, 12; 95% confidence interval, 10 to 13 days;  P <0.001) and hospital length of stay (mean, 25; 95% confidence interval, 22 to 29 days versus mean, 30; 95% confidence interval, 27 to 34 days;  P =0.02). Patients in the AKI-SCAMP group were less likely to receive KRT in the context of physician-perceived treatment futility than those in the control group (2% versus 7%;  P =0.003).
CONCLUSIONS


Use of the AKI-SCAMP tool for AKI KRT was not significantly associated with inpatient mortality, but was associated with reduced intensive care unit length of stay, hospital length of stay, and use of KRT in cases of physician-perceived treatment futility.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Acute Kidney Injury Standardized Clinical Assessment and Management Plan for Renal Replacement Initiation, NCT03368183.
PODCAST


This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2022_02_07_CJN02060221.mp3.",2022,There was no significant difference in inpatient mortality associated with AKI-SCAMP use (41% vs 47% control).,"['ICUs of a large academic tertiary medical center', '122 patients in the AKI-SCAMP group and 102 patients in the control group', 'Acute Kidney Injury']","['AKI-SCAMP', 'kidney replacement therapy (KRT', 'AKI-Standardized Clinical Assessment and Management Plan (SCAMP', 'KRT']","['mortality and length of stay', 'hospital length of stay', 'ICU length of stay', 'ICU and hospital length of stay and use of KRT', 'risk of inpatient mortality', 'inpatient mortality', '30-day mortality, 60-day mortality and hospital and ICU length of stay', 'mortality, hospital and ICU length of stay']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",122.0,0.0840348,There was no significant difference in inpatient mortality associated with AKI-SCAMP use (41% vs 47% control).,"[{'ForeName': 'Yvelynne P', 'Initials': 'YP', 'LastName': 'Kelly', 'Affiliation': ""Division of Renal Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts yvkelly@tcd.ie.""}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Mistry', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': ""Division of Renal Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Shimon', 'Initials': 'S', 'LastName': 'Shaykevich', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Lipsitz', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Leaf', 'Affiliation': ""Division of Renal Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ernest I', 'Initials': 'EI', 'LastName': 'Mandel', 'Affiliation': ""Division of Renal Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': ""Division of Renal Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Gearoid', 'Initials': 'G', 'LastName': 'McMahon', 'Affiliation': ""Division of Renal Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Czarnecki', 'Affiliation': ""Division of Renal Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Charytan', 'Affiliation': 'Nephrology Division, New York University Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Sushrut S', 'Initials': 'SS', 'LastName': 'Waikar', 'Affiliation': 'Section of Nephrology, Boston University School of Medicine and Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Mallika L', 'Initials': 'ML', 'LastName': 'Mendu', 'Affiliation': ""Division of Renal Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.02060221']
1440,34911711,Patient-reported outcome measures for knowledge transfer and behaviour modification interventions in type 2 diabetes-the INDICA study: a multiarm cluster randomised controlled trial.,"OBJECTIVE


This study assesses the effectiveness of different interventions of knowledge transfer and behaviour modification to improve type 2 diabetes mellitus patients' (T2DM) reported outcomes measures (PROMs) in the long-term.  Design : open, community-based pragmatic, multicentre, controlled trial with random allocation by clusters to usual care (UC) or to one of the three interventions.
PARTICIPANTS


A total of 2334 patients with uncomplicated T2DM and 211 healthcare professionals were included of 32 primary care centres.
SETTING


Primary Care Centers in Canary Islands (Spain).
INTERVENTION


The intervention for patients (PTI) included an educational group programme, logs and a web-based platform for monitoring and automated short message service (SMS). The intervention for professionals (PFI) included an educational programme, a decision support tool embedded into the electronic clinical record and periodic feedback about patients' results. A third group received both PTI and PFI (combined intervention, CBI).
OUTCOME MEASURE


Cognitive-attitudinal, behavioural, affective and health-related quality of life (HQoL) variables.
RESULTS


Compared with UC at 24 months, the PTI group significantly improved knowledge (p=0.005), self-empowerment (p=0.002), adherence to dietary recommendations (p<0.001) and distress (p=0.01). The PFI group improved at 24 months in distress (p=0.03) and at 12 months there were improvements in depression (p=0.003), anxiety (p=0.05), HQoL (p=0.005) and self-empowerment (p<0.001). The CBI group improved at 24 months in self-empowerment (p=0.008) and adherence to dietary recommendations (p=0.004) and at 12 months in knowledge (p=0.008), depression (p=0.006), anxiety (p=0.003), distress (p=0.01), HQoL (p<0.001) and neuropathic symptoms (p=0.02). Statistically significant improvements were also observed at 24 months in the proportion of patients who quit smoking for PTI and CBI (41.5% in PTI and 42.3% in CBI vs 21.2% in the UC group).
CONCLUSIONS


Assessed interventions to improve PROMs in T2DM attain effectiveness for knowledge, self-empowerment, distress, diet adherence and tobacco cessation. PTI produced the most lasting benefits.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov NCT01657227 (6 August 2012) https://clinicaltrials.gov/ct2/show/NCT01657227.",2021,"Statistically significant improvements were also observed at 24 months in the proportion of patients who quit smoking for PTI and CBI (41.5% in PTI and 42.3% in CBI vs 21.2% in the UC group).
","['Primary Care Centers in Canary Islands (Spain', 'A total of 2334 patients with uncomplicated T2DM and 211 healthcare professionals were included of 32 primary care centres', ""type 2 diabetes mellitus patients' (T2DM"", 'type 2 diabetes']","['educational group programme, logs and a web-based platform for monitoring and automated short message service (SMS', 'educational programme, a decision support tool embedded into the electronic clinical record and periodic feedback', 'PTI and PFI (combined intervention, CBI']","['HQoL (p=0.005) and self-empowerment', 'adherence to dietary recommendations', 'HQoL (p<0.001) and neuropathic symptoms', 'knowledge transfer and behaviour modification interventions', 'quit smoking for PTI and CBI', 'knowledge (p=0.005), self-empowerment', 'depression', 'distress', 'adherence to dietary recommendations (p<0.001) and distress', 'anxiety', 'PROMs in T2DM attain effectiveness for knowledge, self-empowerment, distress, diet adherence and tobacco cessation', 'Cognitive-attitudinal, behavioural, affective and health-related quality of life (HQoL) variables']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006824', 'cui_str': 'Genus Serinus'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0259095', 'cui_str': '9a-chloromethyl-1,2,9,9a-tetrahydrocyclopropa(c)benz(e)indol-4-one'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0259095', 'cui_str': '9a-chloromethyl-1,2,9,9a-tetrahydrocyclopropa(c)benz(e)indol-4-one'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",2334.0,0.0460418,"Statistically significant improvements were also observed at 24 months in the proportion of patients who quit smoking for PTI and CBI (41.5% in PTI and 42.3% in CBI vs 21.2% in the UC group).
","[{'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Ramallo-Fariña', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain yramfar@sescs.es.'}, {'ForeName': 'Amado', 'Initials': 'A', 'LastName': 'Rivero-Santana', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'García-Pérez', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'García-Bello', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Wägner', 'Affiliation': 'Department of Endocrinology and Nutrition, Insular University Hospital of Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Himar', 'Initials': 'H', 'LastName': 'Gonzalez-Pacheco', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Rodríguez-Rodríguez', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.'}, {'ForeName': 'Sybille', 'Initials': 'S', 'LastName': 'Kaiser-Girardot', 'Affiliation': 'Evaluation Unit (SESCS), Canary Islands Health Services (SCS), Tenerife, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Monzón-Monzón', 'Affiliation': 'Evaluation Unit (SESCS), Canary Islands Health Services (SCS), Tenerife, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Guerra-Marrero', 'Affiliation': 'Evaluation Unit (SESCS), Canary Islands Health Services (SCS), Tenerife, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Daranas-Aguilar', 'Affiliation': 'Evaluation Unit (SESCS), Canary Islands Health Services (SCS), Tenerife, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Roldán-Ruano', 'Affiliation': 'Evaluation Unit (SESCS), Canary Islands Health Services (SCS), Tenerife, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Carmona', 'Affiliation': 'Research Network on Health Services in Chronic Diseases (REDISSEC), Tenerife, Spain.'}, {'ForeName': 'Pedro G', 'Initials': 'PG', 'LastName': 'Serrano-Aguilar', 'Affiliation': 'Research Network on Health Services in Chronic Diseases (REDISSEC), Tenerife, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2021-050804']
1441,34862298,Evaluating the delivery of Problem Management Plus in primary care settings in rural Rwanda: a study protocol using a pragmatic randomised hybrid type 1 effectiveness-implementation design.,"INTRODUCTION


Evidence-based low-intensity psychological interventions such as Problem Management Plus (PM+) have the potential to expand treatment access for depression and anxiety, yet these interventions are not yet effectively implemented in rural, public health systems in resource-limited settings. In 2017, Partners In Health adapted PM+ for delivery by primary care nurses in rural Rwanda and began integrating PM+ into health centres in collaboration with the Rwandan Ministry of Health, using established implementation strategies for mental health integration into primary care (Mentoring and Enhanced Supervision at Health Centers for Mental Health (MESH MH)). A gap in the evidence regarding whether low-intensity psychological interventions can be successfully integrated into real-world primary care settings and improve outcomes for common mental disorders remains. In this study, we will rigorously evaluate the delivery of PM+ by primary care nurses, supported by MESH MH, as it is scaled across one rural district in Rwanda.
METHODS AND ANALYSIS


We will conduct a hybrid type 1 effectiveness-implementation study to test the clinical outcomes of routinely delivered PM+ and to describe the implementation of PM+ at health centres. To study the clinical effectiveness of PM+, we will use a pragmatic, randomised multiple baseline design to determine whether participants experience improvement in depression symptoms (measured by the Patient Health Questionnaire-9) and functioning (measured by the WHO-Disability Assessment Scale Brief 2.0) after receiving PM+. We will employ quantitative and qualitative methods to describe and evaluate PM+ implementation outcomes using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework, using routinely collected programme data and semistructured interviews.
ETHICS AND DISSEMINATION


This evaluation was approved by the Rwanda National Ethics Committee (Protocol #196/RNEC/2019) and deemed exempt by the Harvard University Institutional Review Board. The results from this evaluation will be useful for health systems planners and policy-makers working to translate the evidence base for low-intensity psychological interventions into practice.",2021,The results from this evaluation will be useful for health systems planners and policy-makers working to translate the evidence base for low-intensity psychological interventions into practice.,"['primary care settings in rural Rwanda', 'In 2017, Partners In Health adapted PM+ for delivery by primary care nurses in rural Rwanda and began integrating PM+ into health centres in collaboration with the Rwandan Ministry of Health', 'rural district in Rwanda']","['Problem Management Plus', 'PM']",['depression symptoms'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0468949,The results from this evaluation will be useful for health systems planners and policy-makers working to translate the evidence base for low-intensity psychological interventions into practice.,"[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Smith', 'Affiliation': 'Partners In Health, Boston, Massachusetts, USA stephanie_smith@hms.harvard.edu.'}, {'ForeName': 'Beatha', 'Initials': 'B', 'LastName': 'Nyirandagijimana', 'Affiliation': 'Partners In Health, Kigali, Rwanda.'}, {'ForeName': 'Janvier', 'Initials': 'J', 'LastName': 'Hakizimana', 'Affiliation': 'Partners In Health, Kigali, Rwanda.'}, {'ForeName': 'Roger P', 'Initials': 'RP', 'LastName': 'Levy', 'Affiliation': 'Department of Brain and Cognitive Sciences, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bienvenu', 'Affiliation': 'Partners In Health, Kigali, Rwanda.'}, {'ForeName': 'Anathalie', 'Initials': 'A', 'LastName': 'Uwamwezi', 'Affiliation': 'Partners In Health, Kigali, Rwanda.'}, {'ForeName': 'Octavien', 'Initials': 'O', 'LastName': 'Hakizimfura', 'Affiliation': 'Ministry of Health, Butaro, Rwanda.'}, {'ForeName': 'Eugenie', 'Initials': 'E', 'LastName': 'Uwimana', 'Affiliation': 'Ministry of Health, Butaro, Rwanda.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Kundu', 'Affiliation': 'Partners In Health, Kigali, Rwanda.'}, {'ForeName': 'Egide', 'Initials': 'E', 'LastName': 'Mpanumusingo', 'Affiliation': 'Partners In Health, Kigali, Rwanda.'}, {'ForeName': 'Alphonse', 'Initials': 'A', 'LastName': 'Nshimyiryo', 'Affiliation': 'Partners In Health, Kigali, Rwanda.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rusangwa', 'Affiliation': 'Partners In Health, Kigali, Rwanda.'}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Kateera', 'Affiliation': 'Partners In Health, Kigali, Rwanda.'}, {'ForeName': 'Hildegarde', 'Initials': 'H', 'LastName': 'Mukasakindi', 'Affiliation': 'Partners In Health, Kigali, Rwanda.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Raviola', 'Affiliation': 'Partners In Health, Boston, Massachusetts, USA.'}]",BMJ open,['10.1136/bmjopen-2021-054630']
1442,34921665,Interpretation of the Meaningfulness of Symptom Reduction with Vibegron in Patients with Overactive Bladder: Analyses from EMPOWUR.,"INTRODUCTION


Reductions in bothersome symptoms of overactive bladder (OAB) demonstrate improvement in clinical trials, but patient perception of meaningfulness of such improvement is lacking. In the 12-week phase 3 EMPOWUR trial, vibegron significantly reduced average daily number of micturitions, urgency episodes, and urge urinary incontinence (UUI) episodes vs placebo (P < 0.01 each). This analysis assessed meaningfulness of reductions in clinical endpoints observed in EMPOWUR using patient perception of improvement.
METHODS


An anchor-based approach using Patient Global Impression of Change (PGI-C) applied to phase 2 data allowed predefining phase 3 responder definitions. To confirm in phase 3, median change from baseline at week 12 in average daily number of micturitions, urgency episodes, and UUI episodes was generated for each PGI-C category and pooled across treatments. Based on predefined meaningful responder definitions, percentages of patients achieving ≥ 15% reduction in micturitions (post hoc), ≥ 50% reduction in urgency episodes (predefined), and ≥ 75% (predefined) and ≥ 90% (post hoc) reduction in UUI episodes were determined for patients receiving vibegron or placebo.
RESULTS


Across treatments, for micturitions, urgency episodes, and UUI episodes, median change from baseline to week 12 increased with greater subjective improvement based on PGI-C scores, and median reductions pooled across treatment groups were higher than the responder definitions that patients perceived as improved. Significantly more patients receiving vibegron vs placebo achieved ≥ 15% reduction in micturitions (56.3% vs 44.6%, respectively), ≥ 50% reduction in urgency episodes (39.5% vs 32.8%), ≥ 75% reduction in UUI episodes (49.3% vs 32.8%), and ≥ 90% reduction in UUI episodes (35.2% vs 23.5%) at week 12 (P < 0.05 each).
CONCLUSION


Significantly more patients treated with vibegron vs placebo in EMPOWUR achieved meaningful reductions in micturitions, urgency episodes, and UUI episodes that were associated with patient-perceived improvement. Results of these analyses support the meaningfulness of reductions in clinical endpoints observed in the 12-week EMPOWUR trial.
CLINICAL TRIALS REGISTRATION


ClinicalTrials.gov identifier, NCT03492281.",2022,"Significantly more patients receiving vibegron vs placebo achieved ≥ 15% reduction in micturitions (56.3% vs 44.6%, respectively), ≥ 50% reduction in urgency episodes (39.5% vs 32.8%), ≥ 75% reduction in UUI episodes (49.3% vs 32.8%), and ≥ 90% reduction in UUI episodes (35.2% vs 23.5%) at week 12 (P < 0.05 each).
",['Patients with Overactive Bladder'],"['placebo', 'vibegron vs placebo']","['micturitions, urgency episodes, and UUI episodes', 'average daily number of micturitions, urgency episodes, and urge urinary incontinence (UUI) episodes', 'urgency episodes', 'PGI-C scores', 'UUI episodes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0150045', 'cui_str': 'Urge incontinence of urine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.141701,"Significantly more patients receiving vibegron vs placebo achieved ≥ 15% reduction in micturitions (56.3% vs 44.6%, respectively), ≥ 50% reduction in urgency episodes (39.5% vs 32.8%), ≥ 75% reduction in UUI episodes (49.3% vs 32.8%), and ≥ 90% reduction in UUI episodes (35.2% vs 23.5%) at week 12 (P < 0.05 each).
","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Frankel', 'Affiliation': 'Seattle Urology Research Center, Seattle, WA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': 'Tufts University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Varano', 'Affiliation': 'Clinical Research Consulting, Milford, CT, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kennelly', 'Affiliation': 'Carolinas Medical Center, Charlotte, NC, USA.'}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Newman', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Matt T', 'Initials': 'MT', 'LastName': 'Rosenberg', 'Affiliation': 'Mid-Michigan Health Centers, Jackson, MI, USA.'}, {'ForeName': 'Rachael A', 'Initials': 'RA', 'LastName': 'Jankowich', 'Affiliation': 'Urovant Sciences, Irvine, CA, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Shortino', 'Affiliation': 'Urovant Sciences, Irvine, CA, USA.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Mudd', 'Affiliation': 'Urovant Sciences, Irvine, CA, USA.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Girman', 'Affiliation': 'CERobs Consulting, LLC, 2612 Lumina Avenue North, Wrightsville Beach, Chapel Hill, NC, 28480, USA. cindy.girman@cerobs.com.'}]",Advances in therapy,['10.1007/s12325-021-01972-8']
1443,34905446,"Immunogenicity and safety of an inactivated enterovirus 71 vaccine co-administered with measles-mumps-rubella vaccine and live-attenuated Japanese encephalitis vaccine: a phase 4, single-center, randomized controlled trial.","Co-administration of vaccines could be an efficient strategy to increase vaccination uptake and reduce the number of clinic visits. This randomized controlled study aimed to evaluate the immunogenicity and safety of enterovirus 71 (EV71) vaccine co-administered with measles-mumps-rubella (MMR) vaccine and live-attenuated Japanese encephalitis vaccine (LA-JEV). A total of 372 healthy infants were randomly assigned in a 1:1:1 ratio to receive simultaneous administration of EV71 vaccine (dose 1) and MMR on d 0 and EV71 vaccine (dose 2) and LA-JEV on d 30 (Group 1); administration of MMR and LA-JEV on d 0 and 30, respectively (Group 2); or administration of doses 1 and 2 of EV71 vaccine on d 0 and 30, respectively (Group 3). The non-inferiority analysis of the seroconversion for EV71 neutralizing antibody after vaccination was the primary outcome. According to per protocol set, antibody response against EV71, measles, mumps, rubella, and Japanese encephalitis (JE) virus was similar regardless of administration schedule. After vaccination, the seroconversion rate of EV71 neutralizing antibody in Group 1 (107 [97.27%] of 110) was non-inferior to that in Group 3 (109 [97.32%] of 112; difference - 0.05% [95% CI - 5.38 to 5.21]). The incidences of adverse reactions were 62.60% (77/123) in Group 1, 54.84% (68/124) in Group 2, and 37.70% (46/122) in Group 3, and most of them were mild to moderate in severity. No vaccine-related serious adverse events were reported. In total, the co-administration of combined EV71 vaccine with MMR and LA-JEV showed no interference with antibody response and demonstrated good safety profiles.",2021,"The incidences of adverse reactions were 62.60% (77/123) in Group 1, 54.84% (68/124) in Group 2, and 37.70% (46/122) in Group 3, and most of them were mild to moderate in severity.",['372 healthy infants'],"['MMR and LA-JEV', 'enterovirus 71 (EV71) vaccine co-administered with measles-mumps-rubella (MMR) vaccine and live-attenuated Japanese encephalitis vaccine (LA-JEV', 'EV71 vaccine (dose 1) and MMR on d 0 and EV71 vaccine (dose 2) and LA-JEV', 'inactivated enterovirus 71 vaccine co-administered with measles-mumps-rubella vaccine and live-attenuated Japanese encephalitis vaccine']","['Immunogenicity and safety', 'number of clinic visits', 'immunogenicity and safety', 'seroconversion rate of EV71 neutralizing antibody', 'incidences of adverse reactions']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0035920', 'cui_str': 'Rubella'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0771080', 'cui_str': 'Japanese Encephalitis Vaccines'}, {'cui': 'C3853962', 'cui_str': 'Enterovirus 71 infection'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0025007', 'cui_str': 'Measles'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035923', 'cui_str': 'Rubella virus vaccine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C3853962', 'cui_str': 'Enterovirus 71 infection'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",372.0,0.478826,"The incidences of adverse reactions were 62.60% (77/123) in Group 1, 54.84% (68/124) in Group 2, and 37.70% (46/122) in Group 3, and most of them were mild to moderate in severity.","[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Center for Clinical Evaluation of Vaccines, Shaanxi Provincial Center for Disease Control and Prevention, Xi'an, China.""}, {'ForeName': 'Wanqi', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Sinovac Biotech Co. Ltd, Beijing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Center for Clinical Evaluation of Vaccines, Shaanxi Provincial Center for Disease Control and Prevention, Xi'an, China.""}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Immunology, Hanbin District Center for Disease Control and Prevention, Ankang, China.'}, {'ForeName': 'Ruize', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Center for Clinical Evaluation of Vaccines, Shaanxi Provincial Center for Disease Control and Prevention, Xi'an, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Ding', 'Affiliation': 'Department of Immunology, Hanbin District Center for Disease Control and Prevention, Ankang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Immunology, Hanbin District Center for Disease Control and Prevention, Ankang, China.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Sinovac Biotech Co. Ltd, Beijing, China.'}, {'ForeName': 'Shaobai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Center for Clinical Evaluation of Vaccines, Shaanxi Provincial Center for Disease Control and Prevention, Xi'an, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Sinovac Biotech Co. Ltd, Beijing, China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2021.2010428']
1444,34910188,Efficacy and safety of filgotinib in combination with methotrexate in Japanese patients with active rheumatoid arthritis who have an inadequate response to methotrexate: Subpopulation analyses of 24-week data of a global phase 3 study (FINCH 1).,"OBJECTIVES


Evaluate the efficacy and safety of the Janus kinase-1 inhibitor filgotinib in Japanese patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX).
METHODS


Data from 147 Japanese patients in FINCH 1, a 52-week global Phase 3 study, were analysed up to 24 weeks. Patients received once-daily filgotinib 200 or 100 mg, biweekly adalimumab, or placebo, all with stable background MTX.
RESULTS


In the Japanese population, American College of Rheumatology 20% response rates at Week 12 (primary endpoint) were 77.5%, 65.9%, 53.6%, and 36.8% for filgotinib 200 mg, filgotinib 100 mg, adalimumab, and placebo. Proportions of patients achieving Disease Activity Score with 28 joints <2.6 at Week 24: filgotinib 200 mg, 65.0%; filgotinib 100 mg, 51.2%; adalimumab, 42.9%; and placebo, 5.3%. Incidence rates of serious infections: filgotinib 200 mg, 2.5%; filgotinib 100 mg, 0%; adalimumab, 10.7%; and placebo, 5.3%. Treatment-emergent laboratory abnormalities Grade ≥3 occurred in five (12.5%) filgotinib 200 mg, three (7.3%) filgotinib 100 mg, one (3.6%) adalimumab, and no placebo patients. No deaths were reported among Japanese patients.
CONCLUSIONS


Filgotinib once daily combined with MTX was effective and generally safe and well tolerated up to Week 24 in Japanese patients with RA and inadequate response to MTX.",2022,"Treatment-emergent laboratory abnormalities Grade ≥3 occurred in five (12.5%) filgotinib 200 mg, three (7.3%) filgotinib 100 ","['Japanese patients with active rheumatoid arthritis who have an inadequate response to', 'Japanese patients with RA', 'Data from 147 Japanese patients in FINCH 1, a 52-week global Phase 3 study, were analysed up to 24\u2009weeks', 'Japanese patients with rheumatoid arthritis (RA']","['placebo', 'methotrexate', 'methotrexate (MTX', 'filgotinib', 'MTX', 'adalimumab', 'once-daily filgotinib 200 or 100\u2009mg, biweekly adalimumab, or placebo, all with stable background MTX']","['Efficacy and safety', 'Disease Activity Score', 'efficacy and safety', 'effective and generally safe and well tolerated', 'Incidence rates of serious infections']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0326914', 'cui_str': 'Family Fringillidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",147.0,0.212755,"Treatment-emergent laboratory abnormalities Grade ≥3 occurred in five (12.5%) filgotinib 200 mg, three (7.3%) filgotinib 100 ","[{'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Matsubara', 'Affiliation': 'Department of Orthopedics, Matsubara Mayflower Hospital, Hyogo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University, Hokkaido, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Amano', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ishiguro', 'Affiliation': ''}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Yamaoka', 'Affiliation': 'Department of Rheumatology and Infectious Diseases, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Bernard G', 'Initials': 'BG', 'LastName': 'Combe', 'Affiliation': 'Rheumatology Department, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, PA, USA.'}, {'ForeName': 'Sang-Cheol', 'Initials': 'SC', 'LastName': 'Bae', 'Affiliation': 'Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Keystone', 'Affiliation': 'Department of Medicine, University of Toronto, Mount Sinai Hospital, Toronto, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Griffith University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Matzkies', 'Affiliation': 'Gilead Sciences Inc, Foster City, CA, USA.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Bartok', 'Affiliation': 'Gilead Sciences Inc, Foster City, CA, USA.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Pechonkina', 'Affiliation': 'Gilead Sciences Inc, Foster City, CA, USA.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kondo', 'Affiliation': 'Gilead Sciences K.K, Gran Tokyo South Tower, Tokyo, Japan.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Gilead Sciences Inc, Foster City, CA, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Gilead Sciences Inc, Foster City, CA, USA.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Tasset', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Sundy', 'Affiliation': 'Gilead Sciences Inc, Foster City, CA, USA.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}]",Modern rheumatology,['10.1093/mr/roab030']
1445,34910161,"Oligofructose-Enriched Inulin Intake, Gut Microbiome Characteristics, and the V̇O2 Peak Response to High-Intensity Interval Training in Healthy Inactive Adults.","BACKGROUND


The gut microbiome has been associated with cardiorespiratory fitness.
OBJECTIVES


To assess the effects of oligofructose (FOS)-enriched inulin supplementation on the gut microbiome and the peak oxygen uptake (V̇O2peak) response to high-intensity interval training (HIIT).
METHODS


The study was a randomized controlled trial. Forty sedentary and apparently healthy adults [n = 31 women; aged 31.8 ± 9.8 y, BMI (in kg⋅m-2) 25.9 ± 4.3] were randomly allocated to 1) 6 wk of supervised HIIT (4 × 4-min bouts at 85-95% peak heart rate, interspersed with 3 min of active recovery, 3·wk-1) + 12 g·d-1 of FOS-enriched inulin (HIIT-I) or 2) 6 wk of supervised HIIT (3·wk-1, 4 × 4-min bouts) + 12 g·d-1 of maltodextrin/placebo (HIIT-P). Each participant completed an incremental treadmill test to assess V̇O2peak and ventilatory thresholds (VTs), provided a stool and blood sample, and completed a 24-h diet recall questionnaire and FFQ before and after the intervention. Gut microbiome analyses were performed using metagenomic sequencing. Fecal short-chain fatty acids were measured by mass spectrometry.
RESULTS


There were no differences in the mean change in V̇O2peak response between groups (P = 0.58). HIIT-I had a greater improvement in VTs than HIIT-P [VT1 (lactate accumulation): mean difference + 4.3% and VT2 (lactate threshold): +4.2%, P < 0.05]. HIIT-I had a greater increase in the abundance of Bifidobacterium taxa [false discovery rate (FDR) < 0.05] and several metabolic processes related to exercise capacity (FDR < 0.05). Exploratory analysis of merged data found participants with a greater response to HIIT (V̇O2peak ≥3.5 mL⋅kg-1⋅min-1) had a 2.2-fold greater mean abundance of gellan degradation pathways (FDR < 0.05) and a greater, but not significant, abundance of Bifidobacterium uniformis species (P < 0.00023, FDR = 0.08).
CONCLUSIONS


FOS-enriched inulin supplementation did not potentiate HIIT-induced improvements in V̇O2peak but led to gut microbiome changes possibly associated with greater ventilatory threshold improvements in healthy inactive adults. Gellan degradation pathways and B. uniformis spp. were associated with greater V̇O2peak responses to HIIT.",2022,HIIT-I had a greater increase in the abundance of Bifidobacterium taxa (False Discovery Rate (FDR) <0.05) and several metabolic processes related to exercise capacity (FDR <0.05).,"['healthy inactive adults', 'Forty sedentary and apparently healthy adults (n = 31 females; age = 31.8±9.8 years, BMI = 25.9±4.3 kg·m-2']","['incremental treadmill test to assess V̇O2peak and ventilatory thresholds (VTs', 'oligofructose (FOS)-enriched inulin supplementation', 'supervised HIIT (4×4 min bouts at 85-95% HRpeak, interspersed with 3 min of active recovery, 3·week-1) + 12 g·day-1 of FOS-enriched inulin (HIIT-I) or ii) six weeks of supervised HIIT (3·week-1, 4×4 min bouts) + 12 g·day-1 of maltodextrin/placebo (HIIT-P']","['mean abundance of gellan degradation pathways', 'mean change in V̇O2peak response', 'Fecal short-chain fatty acids', 'peak oxygen uptake (V̇O2peak) response', 'abundance of Bifidobacterium taxa (False Discovery Rate (FDR) <0.05) and several metabolic processes']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0087110', 'cui_str': 'Treadmill Test'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0907858', 'cui_str': 'oligofructose'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0087140', 'cui_str': 'v-fos Oncogenes'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0119025', 'cui_str': 'gellan'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",40.0,0.0807021,HIIT-I had a greater increase in the abundance of Bifidobacterium taxa (False Discovery Rate (FDR) <0.05) and several metabolic processes related to exercise capacity (FDR <0.05).,"[{'ForeName': 'Camilla J', 'Initials': 'CJ', 'LastName': 'Williams', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, University of Queensland, St. Lucia, QLD, Australia.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Torquati', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, University of Queensland, St. Lucia, QLD, Australia.'}, {'ForeName': 'Zhixiu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Genomics and Personalised Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Rodney A', 'Initials': 'RA', 'LastName': 'Lea', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Genomics and Personalised Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Croci', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, University of Queensland, St. Lucia, QLD, Australia.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Keating', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, University of Queensland, St. Lucia, QLD, Australia.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Eynon', 'Affiliation': 'Institute for Health and Sport (iHeS), Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, University of Queensland, St. Lucia, QLD, Australia.'}]",The Journal of nutrition,['10.1093/jn/nxab426']
1446,34910136,Long-term safety and efficacy of anacetrapib in patients with atherosclerotic vascular disease.,"AIMS


REVEAL was the first randomized controlled trial to demonstrate that adding cholesteryl ester transfer protein inhibitor therapy to intensive statin therapy reduced the risk of major coronary events. We now report results from extended follow-up beyond the scheduled study treatment period.
METHODS AND RESULTS


A total of 30 449 adults with prior atherosclerotic vascular disease were randomly allocated to anacetrapib 100 mg daily or matching placebo, in addition to open-label atorvastatin therapy. After stopping the randomly allocated treatment, 26 129 survivors entered a post-trial follow-up period, blind to their original treatment allocation. The primary outcome was first post-randomization major coronary event (i.e. coronary death, myocardial infarction, or coronary revascularization) during the in-trial and post-trial treatment periods, with analysis by intention-to-treat. Allocation to anacetrapib conferred a 9% [95% confidence interval (CI) 3-15%; P = 0.004] proportional reduction in the incidence of major coronary events during the study treatment period (median 4.1 years). During extended follow-up (median 2.2 years), there was a further 20% (95% CI 10-29%; P < 0.001) reduction. Overall, there was a 12% (95% CI 7-17%, P < 0.001) proportional reduction in major coronary events during the overall follow-up period (median 6.3 years), corresponding to a 1.8% (95% CI 1.0-2.6%) absolute reduction. There were no significant effects on non-vascular mortality, site-specific cancer, or other serious adverse events. Morbidity follow-up was obtained for 25 784 (99%) participants.
CONCLUSION


The beneficial effects of anacetrapib on major coronary events increased with longer follow-up, and no adverse effects emerged on non-vascular mortality or morbidity. These findings illustrate the importance of sufficiently long treatment and follow-up duration in randomized trials of lipid-modifying agents to assess their full benefits and potential harms.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN) 48678192; ClinicalTrials.gov No. NCT01252953; EudraCT No. 2010-023467-18.
KEY QUESTION


What were the long-term effects of anacetrapib on atherosclerotic vascular disease during longer-term follow-up of the REVEAL randomized controlled trial?
KEY FINDINGS


The beneficial effects of anacetrapib on major coronary events increased with longer follow-up and no safety signals emerged. No adverse effects emerged on non-vascular mortality or morbidity.
TAKE-HOME MESSAGE


Trials of lipid-modifying agents need to have sufficiently long treatment and follow-up durations to fully assess the benefits and harms of treatment.",2021,The beneficial effects of anacetrapib on major coronary events increased with longer follow-up and no safety signals emerged.,"['A total of 30\xa0449 adults with prior atherosclerotic vascular disease', 'patients with atherosclerotic vascular disease']","['NCT01252953; EudraCT', 'anacetrapib 100\u2009mg daily or matching placebo, in addition to open-label atorvastatin therapy', 'cholesteryl ester transfer protein inhibitor therapy', 'anacetrapib']","['non-vascular mortality, site-specific cancer, or other serious adverse events', 'major coronary events', 'Morbidity follow-up', 'atherosclerotic vascular disease', 'first post-randomization major coronary event (i.e. coronary death, myocardial infarction, or coronary revascularization', 'vascular mortality or morbidity', 'risk of major coronary events']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2604745', 'cui_str': 'anacetrapib'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0055538', 'cui_str': 'Cholesterol ester transfer protein'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449604', 'cui_str': 'Specific site'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",30449.0,0.295971,The beneficial effects of anacetrapib on major coronary events increased with longer follow-up and no safety signals emerged.,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sammons', 'Affiliation': 'REVEAL Central Coordinating Office, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Hopewell', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wallendszus', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Valdes-Marquez', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dayanandan', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Knott', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wincott', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Baxter', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Goodenough', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lay', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Macdonnell', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fabbri', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lucci', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fajardo-Moser', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Brenner', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hao', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Wuhan', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mosegaard', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Herrington', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Angermann', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ertl', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maggioni', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Barter', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mihaylova', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Mitchel', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Blaustein', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Goto', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tobert', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'DeLucca', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Armitage', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Baigent', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wiviott', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cannon', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bowman', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Landray', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehab863']
1447,34915178,ACUTE TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS) IMPROVES VENTILATORY VARIABILITY AND AUTONOMIC MODULATION IN RESISTANT HYPERTENSIVE PATIENTS.,"Here, we assessed the impact of one session of transcranial direct current stimulation (tDCS) or SHAM (20 min, each) on ventilatory responses to cardiopulmonary exercise test, central and peripheral blood pressure (BP), and autonomic modulation in resistant hypertensive (RHT) patients. RHT subjects (n = 13) were randomly submitted to SHAM and tDCS crossing sessions (1 week of ""washout""). Patients and a technician who set the tDCS/Sham room up were both blind. After brain stimulation, patients were submitted to a cardiopulmonary exercise test to evaluate ventilatory and cardiovascular response to exercise. Hemodynamic (Finometer®, Beatscope), and autonomic variables were measured at baseline (before tDCS/Sham) and after incremental exercise. RESULTS: Our study shows that tDCS condition improved heart rate recovery, VO2 peak, and vagal modulation (after cardiopulmonary exercise test); attenuated the ventilatory variability response, central and peripheral blood pressure well as sympathetic modulation (after cardiopulmonary exercise test) in comparison with SHAM. These data suggest that acute tDCS sessions prevented oscillatory ventilation behavior during the cardiopulmonary exercise test and mitigated the increase of systolic blood pressure in RHT patients. After the exercise test, tDCS promotes better vagal reentry and improved autonomic modulation, possibly reducing central blood pressure and aortic augmentation index compared to SHAM. Brazilian Registry of Clinical Trials (ReBEC): https://ensaiosclinicos.gov.br/rg/RBR-8n7c9p.",2022,"After the exercise test, tDCS promotes better vagal reentry and improved autonomic modulation, possibly reducing central blood pressure and aortic augmentation index compared to SHAM.","['RHT subjects (n = 13', 'resistant hypertensive (RHT) patients', 'RHT patients']","['transcranial direct current stimulation (tDCS) or SHAM', 'SHAM and tDCS crossing sessions', 'cardiopulmonary exercise test']","['ventilatory responses to cardiopulmonary exercise test, central and peripheral blood pressure (BP), and autonomic modulation', 'central blood pressure and aortic augmentation index', 'ventilatory variability response, central and peripheral blood pressure well as sympathetic modulation', 'oscillatory ventilation behavior', 'vagal reentry and improved autonomic modulation', 'systolic blood pressure', 'heart rate recovery, VO2 peak, and vagal modulation', 'Hemodynamic (Finometer®, Beatscope), and autonomic variables']","[{'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",13.0,0.0498101,"After the exercise test, tDCS promotes better vagal reentry and improved autonomic modulation, possibly reducing central blood pressure and aortic augmentation index compared to SHAM.","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Ministro', 'Affiliation': 'Laboratory of Cardiovascular Investigation & Exercise, School of Physical Education, University of Campinas (UNICAMP), Campinas, SP, Brazil.'}, {'ForeName': 'Javier B', 'Initials': 'JB', 'LastName': 'Castaño', 'Affiliation': 'Laboratory of Cardiovascular Investigation & Exercise, School of Physical Education, University of Campinas (UNICAMP), Campinas, SP, Brazil.'}, {'ForeName': 'Catarina A', 'Initials': 'CA', 'LastName': 'Barboza', 'Affiliation': 'Laboratory of Cardiovascular Investigation & Exercise, School of Physical Education, University of Campinas (UNICAMP), Campinas, SP, Brazil.'}, {'ForeName': 'Eliezer G', 'Initials': 'EG', 'LastName': 'Moura', 'Affiliation': 'Laboratory of Cardiovascular Investigation & Exercise, School of Physical Education, University of Campinas (UNICAMP), Campinas, SP, Brazil.'}, {'ForeName': 'Silvia E', 'Initials': 'SE', 'LastName': 'Ferreira-Melo', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology & Hypertension, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, SP, Brazil.'}, {'ForeName': 'Cristiano T', 'Initials': 'CT', 'LastName': 'Mostarda', 'Affiliation': 'Federal University of Maranhão, São Luís, MA, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Fattori', 'Affiliation': 'Department of Clinical Medicine, University of Campinas (UNICAMP), Campinas, SP, Brazil.'}, {'ForeName': 'Heitor', 'Initials': 'H', 'LastName': 'Moreno-Junior', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology & Hypertension, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, SP, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Rodrigues', 'Affiliation': 'Laboratory of Cardiovascular Investigation & Exercise, School of Physical Education, University of Campinas (UNICAMP), Campinas, SP, Brazil; Laboratory of Cardiovascular Pharmacology & Hypertension, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, SP, Brazil. Electronic address: prof.brodrigues@gmail.com.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2021.103830']
1448,34915083,The effects of Autonomous Sensory Meridian Response (ASMR) videos on arousal and mood in adults with and without depression and insomnia.,"BACKGROUND


Autonomous Sensory Meridian Response (ASMR) is a pleasant physiological tingling sensation induced by certain visual and auditory triggers. ASMR has been shown to reduce stress and increase positive mood, but its effects have not yet been studied in populations with clinically severe symptoms. The present study aimed to investigate whether the experience of ASMR improved mood and reduced arousal in people with and without insomnia and depression symptoms.
METHODS


1,037 participants (18-66 years) completed online questionnaires assessing insomnia and depression symptom severity followed by questionnaires on current mood and arousal levels before and after watching an ASMR video. The independent variables were the participant's group (insomnia, depression, insomnia and depression combined or control) and whether they experienced ASMR during the video. The dependent variables were the change in mood and arousal levels after watching the video.
RESULTS


As predicted, all participants showed significantly increased relaxation and improved mood after watching the video with the largest effects for participants who experienced ASMR and for participants in the combined and depression groups. No difference was found between the insomnia and control groups.
LIMITATIONS


It is not known how many participants were familiar with ASMR videos prior to taking part in the study (nor whether this is important). Also, the categorization of participants into the ASMR group was based on self-report and thus, not verified.
CONCLUSIONS


Results suggest that ASMR videos have the potential to be used to improve mood and reduce arousal with implications for alleviating symptoms of insomnia and depression.",2022,"As predicted, all participants showed significantly increased relaxation and improved mood after watching the video with the largest effects for participants who experienced ASMR and for participants in the combined and depression groups.","['adults with and without depression and insomnia', '1,037 participants (18-66 years) completed', 'people with and without insomnia and depression symptoms']","['Autonomous Sensory Meridian Response (ASMR) videos', 'ASMR videos']","['online questionnaires assessing insomnia and depression symptom severity', 'mood and arousal levels', 'relaxation and improved mood', 'insomnia, depression, insomnia and depression combined or control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C4508986', 'cui_str': 'Improved mood'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",1037.0,0.0631609,"As predicted, all participants showed significantly increased relaxation and improved mood after watching the video with the largest effects for participants who experienced ASMR and for participants in the combined and depression groups.","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Smejka', 'Affiliation': 'Centre for Psychological Research, Department of Psychology, Health and Professional Development, Oxford Brookes University, Gipsy Lane, Headington, Oxford OX3 0BP, UK.'}, {'ForeName': 'Luci', 'Initials': 'L', 'LastName': 'Wiggs', 'Affiliation': 'Centre for Psychological Research, Department of Psychology, Health and Professional Development, Oxford Brookes University, Gipsy Lane, Headington, Oxford OX3 0BP, UK. Electronic address: lwiggs@brookes.ac.uk.'}]",Journal of affective disorders,['10.1016/j.jad.2021.12.015']
1449,34915202,"An innovative antimicrobial stewardship programme for children in remote and regional areas in Queensland, Australia: optimising antibiotic use through timely intravenous-to-oral switch.","OBJECTIVES


Little is known about the benefits of timely switch from intravenous (IV) to oral antibiotic therapy in children. We evaluated the appropriateness of IV-to-oral switch of antibiotic therapy in remote and regional areas of Australia following the implementation of a multifaceted package of interventions.
METHODS


The intervention package, including clinician guidelines, medication review stickers, patient information leaflets and educational resources, was implemented in seven facilities in Queensland, Australia. Children with community-acquired pneumonia and skin and soft-tissue infections were switched to oral therapy if they met the required 'IV-to-oral switch' criteria. Data were collected for a 7-month period from May to November for the baseline (2018) and intervention (2019) phases.
RESULTS


A total of 357 patients were enrolled in the study, including 178 in the baseline phase and 179 in the intervention phase. The percentage of patients who switched to oral therapy or stopped IV antibiotics, within 24 h of eligibility, increased from 87.6% (156/178) in the baseline phase to 97.2% (174/179) in the intervention phase (P = 0.003). The average number of extra IV days decreased from 0.45 days in the baseline period to 0.18 days in the intervention period (P < 0.001). The median patient length of stay was 2 days for both phases. The only adverse events recorded were line-associated infiltration, with a decrease from 34.3% (61/178) (baseline) to 17.9% (32/179) (intervention) (P < 0.001).
CONCLUSION


A multifaceted intervention package to enhance timely IV-to-oral switch of antibiotic therapy for children in remote and regional facilities is effective.",2021,"The only adverse events recorded were line-associated infiltration, with a decrease from 34.3% (61/178) (baseline) to 17.9% (32/179) (intervention) (P < 0.001).
","['children in remote and regional areas in Queensland, Australia', 'Children with community-acquired pneumonia and skin and soft-tissue infections', 'children in remote and regional facilities', 'children', 'A total of 357 patients were enrolled in the study, including 178 in the baseline phase and 179 in the intervention phase']","['antibiotic therapy', 'antimicrobial stewardship programme']","['average number of extra IV days', 'median patient length of stay']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0149778', 'cui_str': 'Soft tissue infection'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",357.0,0.0768688,"The only adverse events recorded were line-associated infiltration, with a decrease from 34.3% (61/178) (baseline) to 17.9% (32/179) (intervention) (P < 0.001).
","[{'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Avent', 'Affiliation': 'Queensland Statewide Antimicrobial Stewardship Program, Queensland Health, Brisbane, Queensland, Australia; UQ Centre for Clinical Research (UQCCR), The University of Queensland, Brisbane, Queensland, Australia. Electronic address: minyon.avent@health.qld.gov.au.'}, {'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Lee', 'Affiliation': 'Australian Centre for Health Services Innovation (AusHSI) and Centre for Healthcare Transformation, School of Public Health and Social Work, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Irwin', 'Affiliation': ""Infection Management and Prevention Service, Queensland Children's Hospital, Brisbane, Queensland, Australia; School of Clinical Medicine, University of Queensland, Brisbane, Queensland, Australia.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Graham', 'Affiliation': ""Pharmacy Department and Infection Management and Prevention Service, Queensland Children's Hospital, Children's Health Queensland, Australia.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Brain', 'Affiliation': 'Australian Centre for Health Services Innovation (AusHSI) and Centre for Healthcare Transformation, School of Public Health and Social Work, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fejzic', 'Affiliation': 'School of Pharmacy, University of Queensland, The Pharmacy Australia Centre of Excellence, Brisbane, Queensland, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Driel', 'Affiliation': 'Primary Care Clinical Unit, Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Clark', 'Affiliation': ""Infection Management and Prevention Service, Queensland Children's Hospital, Brisbane, Queensland, Australia; School of Clinical Medicine, University of Queensland, Brisbane, Queensland, Australia.""}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2021.11.014']
1450,34906445,"Epidemiology, ventilation management and outcome in patients receiving intensive care after non-thoracic surgery - Insights from the LAS VEGAS study.","INTRODUCTION AND OBJECTIVES


Information about epidemiology, ventilation management and outcome in postoperative intensive care unit (ICU) patients remains scarce. The objective was to test whether postoperative ventilation differs from that in the operation room.
MATERIAL AND METHODS


This was a substudy of the worldwide observational LAS VEGAS study, including patients undergoing non-thoracic surgeries. Of 146 study sites participating in the LAS VEGAS study, 117 (80%) sites reported on the postoperative ICU course, including ventilation and complications. The coprimary outcomes were two key elements of ventilator management, i.e., tidal volume (V T ) and positive end-expiratory pressure (PEEP). Secondary outcomes included the proportion of patients receiving low V T  ventilation (LTVV, defined as ventilation with a median V T  < 8.0 ml/kg PBW), and the proportion of patients developing postoperative pulmonary complications (PPC), including ARDS, pneumothorax, pneumonia and need for escalation of ventilatory support, ICU and hospital length of stay, and mortality at day 28.
RESULTS


Of 653 patients who were admitted to the ICU after surgery, 274 (42%) patients received invasive postoperative ventilation. Median postoperative V T  was 8.4 [7.3-9.8] ml/kg predicted body weight (PBW), PEEP was 5 [5-5] cm H 2 O, statistically significant but not meaningfully different from median intraoperative V T  (8.1 [7.3-8.9] ml/kg PBW; P < 0.001) and PEEP (4 [2-5] cm H 2 O; P < 0.001). The proportion of patients receiving LTVV after surgery was 41%. The PPC rate was 10%. Length of stay in ICU and hospital was independent of development of a PPC, but hospital mortality was higher in patients who developed a PPC (24 versus 4%; P < 0.001).
CONCLUSIONS


In this observational study of patients undergoing non-thoracic surgeries, postoperative ventilation was not meaningfully different from that in the operating room. Like in the operating room, there is room for improved use of LTVV. Development of PPC is associated with mortality.",2022,"Length of stay in ICU and hospital was independent of development of a PPC, but hospital mortality was higher in patients who developed a PPC (24 versus 4%; P < 0.001).
","['Of 146 study sites participating in the LAS VEGAS study, 117 (80%) sites reported on the', 'patients undergoing non-thoracic surgeries', '653 patients who were admitted to the ICU after surgery, 274 (42', 'patients receiving intensive care after non-thoracic surgery - Insights from the LAS VEGAS study', 'patients undergoing non-thoracic surgeries, postoperative ventilation was not meaningfully different from that in the operating room', 'postoperative intensive care unit']",['invasive postoperative ventilation'],"['Median postoperative V T', 'hospital mortality', 'PPC rate', 'Length of stay in ICU and hospital', 'postoperative ICU course, including ventilation and complications', 'ventilator management, i.e., tidal volume (V T ) and positive end-expiratory pressure (PEEP', 'body weight (PBW', 'proportion of patients receiving low V T  ventilation (LTVV, defined as ventilation with a median V T  < 8.0 ml/kg PBW), and the proportion of patients developing postoperative pulmonary complications (PPC), including ARDS, pneumothorax, pneumonia and need for escalation of ventilatory support, ICU and hospital length of stay, and mortality at day 28']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184634', 'cui_str': 'Ventilator care'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",653.0,0.105834,"Length of stay in ICU and hospital was independent of development of a PPC, but hospital mortality was higher in patients who developed a PPC (24 versus 4%; P < 0.001).
","[{'ForeName': 'F D', 'Initials': 'FD', 'LastName': 'Simonis', 'Affiliation': 'Department of Intensive Care, Amsterdam UMC, location Academic Medical Center, Amsterdam, the Netherlands. Electronic address: f.d.simonis@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Einav', 'Affiliation': 'General Intensive Care Unit, Shaare Zedek Medical Center and Hebrew University Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Serpa Neto', 'Affiliation': 'Department of Intensive Care, Amsterdam UMC, location Academic Medical Center, Amsterdam, the Netherlands; Department of Critical Care Medicine, Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), Monash University, Melbourne, Australia.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Hemmes', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, location Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics, IRCCS San Martino IST, University of Genoa, Genoa, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gama de Abreu', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Schultz', 'Affiliation': 'Department of Intensive Care, Amsterdam UMC, location Academic Medical Center, Amsterdam, the Netherlands; Mahidol Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand; Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}]",Pulmonology,['10.1016/j.pulmoe.2021.10.004']
1451,34906881,The impact of cigarette pack anti-littering messages.,"OBJECTIVE


Tobacco butts are the most littered item worldwide and pose a critical environmental and public health hazard. Given the positive impact of required graphic warnings on smoking, we sought to assess the impact of a policy requiring cigarette pack anti-littering messages on smokers' littering intentions.
METHODS


We randomly assigned US adult smokers (n = 719) to receive labels on the side of their cigarette packs for three weeks: anti-littering messages or messages about chemicals in cigarette smoke.
RESULTS


Anti-littering messages elicited higher intentions to refrain from littering in the next month compared to chemical messages (p < .05). Anti-littering messages also led to increased knowledge about cigarette butts being the most common form of litter, the number of conversations about littering, and thinking about the proper disposal of cigarettes (all p < .05). Finally, smoking from packs labeled with anti-littering messages led to fewer weeks littering from car windows compared to packs labeled with chemical messages (p < .05), but did not affect completely refraining from littering cigarette butts. Mediators of the messages' impact on littering intentions were thinking about proper cigarette butt disposal and perceived message effectiveness (both p < .05).
CONCLUSIONS


Policies requiring anti-littering messages on cigarette packs would raise awareness about the problem of cigarette butt litter and bolster intentions to not litter.",2022,"RESULTS


Anti-littering messages elicited higher intentions to refrain from littering in the next month compared to chemical messages (p < .05).",['adult smokers (n\xa0=\xa0719) to'],"['policy requiring cigarette pack anti-littering messages', 'receive labels on the side of their cigarette packs for three weeks: anti-littering messages or messages about chemicals in cigarette smoke', 'cigarette pack anti-littering messages']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0150789', 'cui_str': 'Stretcher'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}]",[],,0.0750559,"RESULTS


Anti-littering messages elicited higher intentions to refrain from littering in the next month compared to chemical messages (p < .05).","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Morgan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, United States; Annenberg School for Communication, University of Pennsylvania, United States. Electronic address: Jennifer.Morgan@asc.upenn.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Jeong', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, United States; Center for Tobacco Studies, Rutgers University, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mendel-Sheldon', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, United States; Lineberger Comprehensive Cancer Center, University of North Carolina, United States.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Noar', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, United States; Hussman School of Journalism and Media, University of North Carolina, United States.'}, {'ForeName': 'Kurt M', 'Initials': 'KM', 'LastName': 'Ribisl', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, United States; Lineberger Comprehensive Cancer Center, University of North Carolina, United States.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, United States; Lineberger Comprehensive Cancer Center, University of North Carolina, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2021.107184']
1452,34907094,Laparoscopic radical distal pancreatosplenectomy with celiac axis excision following neoadjuvant chemotherapy for locally advanced pancreatic cancer.,"A recent successful prospective randomized control study comparing open distal pancreatectomy with laparoscopic distal pancreatectomy (LDP) has shown that LDP is a safe and effective surgical modality in treating left-sided pancreatic pathological conditions requiring surgical extirpation. With the accumulating surgical experiences and improved surgical techniques, we recently reported several cases of successful LDP in advanced pancreatic cancer following neoadjuvant chemotherapy. Herein, we report a case of LDP with celiac axis resection (LDP-CAR) in locally advanced pancreatic cancer (LAPC) following neoadjuvant chemotherapy. A 58-year-old female with LAPC was referred to our institution. Computed tomography (CT) findings revealed a 24-mm mass in the pancreatic body that showed celiac artery (CA), common hepatic artery abutment. There was no abutment with superior mesenteric artery, superior mesenteric vein, and portal vein. From these findings, Neoadjuvant chemotherapy (FORFIRINOX) was performed biweekly. After 8 cycles of chemotherapy, the tumor size was slightly decreased (24 mm to 16 mm), but still abutting to CA. After 14 cycles of chemotherapy, CT revealed the same tumor size (16 mm) still abutting to CA. LDP-CAR was performed. Intraoperative ultrasonography gastric perfusion and hepatic perfusion were confirmed using indocyanine green. The patient recovered without complications and was discharged from the hospital nine days after the surgery.",2022,"After 8 cycles of chemotherapy, the tumor size was slightly decreased (24 mm to 16 mm), but still abutting to CA.","['locally advanced pancreatic cancer (LAPC', 'A 58-year-old female with LAPC', 'locally advanced pancreatic cancer']","['laparoscopic distal pancreatectomy (LDP', 'chemotherapy, CT', 'indocyanine green', 'LDP', 'Computed tomography (CT', 'LDP with celiac axis resection (LDP-CAR', 'neoadjuvant chemotherapy', 'Laparoscopic radical distal pancreatosplenectomy with celiac axis excision']","['tumor size', 'Intraoperative ultrasonography gastric perfusion and hepatic perfusion', 'superior mesenteric artery, superior mesenteric vein, and portal vein']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0007569', 'cui_str': 'Structure of celiac artery'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0205108', 'cui_str': 'Distal'}]","[{'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C2368278', 'cui_str': 'Intraoperative ultrasonography'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0162861', 'cui_str': 'Superior mesenteric artery structure'}, {'cui': 'C0226742', 'cui_str': 'Structure of superior mesenteric vein'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}]",,0.0292769,"After 8 cycles of chemotherapy, the tumor size was slightly decreased (24 mm to 16 mm), but still abutting to CA.","[{'ForeName': 'Yeon Su', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Su', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ho Kyoung', 'Initials': 'HK', 'LastName': 'Hwang', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Woo Jung', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chang Moo', 'Initials': 'CM', 'LastName': 'Kang', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.'}]",Annals of hepato-biliary-pancreatic surgery,['10.14701/ahbps.21-097']
1453,34907051,"Protocol for thiamine and folic acid in the treatment of cognitive impairment in maintenance haemodialysis patients: a prospective, randomised, placebo-controlled, double-blind, multicentre study.","INTRODUCTION


Cognitive impairment (CI) is the common complications in maintenance haemodialysis (MHD) patients. Recently, the pathogenesis of CI has been discussed and oxidative stress is one of the main mechanisms in these patients. Thiamine and folic acid, which play an important role in relieving the production of reactive oxygen species, reducing homocysteine levels, improving oxidative stress in the nervous system. In pilot study, cognitive function was significantly improved in the group with thiamine and folic supplementation. Based on this result, we hypothesise that thiamine combined with folic acid supplementation may improve cognitive function in patients with MHD.
METHODS AND ANALYSIS


In this prospective, randomised, placebo-controlled, double-blind, multicentre study, we will enrol patients undergoing haemodialysis who has the Montreal Cognitive Assessment score lower than 26 to treatment group (thiamine 90 mg/day combined with folic acid 30 mg/day) or control group (thiamine placebo 90 mg/day combined with folic acid placebo 30 mg/day). All subjects will be followed up for 96 weeks. The primary endpoint is the comparison of Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) score between treatment group and control group at 96 weeks of follow-up. The secondary endpoints include serum thiamine, folate, homocysteine levels, cranial functional MRI and survival. The central randomisation method will be adopted and the principles of placebo-controlled, double-blind randomised control will be followed. The comparisons among ADAS-Cog scores and other secondary endpoints over time within subjects is conducted by using repeated measure analysis of variance (ANOVA) or generalised estimating equations (GEE). Pairwise t-test with Bonferroni adjustment is performed for multiple comparisons. On the other hand, for comparisons between treatment and control group, simple one-way ANOVA, GEE or Wilcoxon rank sum test is used. The χ 2  method is used for statistical analysis of the categorical data. Kaplan-Meier survival curve is used for survival analysis. A p<0.05 is considered statistically significant difference.
ETHICS AND DISSEMINATION


This trial has been approved by Shanghai Jiao Tong University School of Medicine, Renji Hospital Ethics Committee (KY2019-199). After publication of study results, trial report will be published in peer-reviewed journals and/or in national or international conferences.
TRIAL REGISTRATION NUMBER


ChiCTR2000029297.",2021,The primary endpoint is the comparison of Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) score between treatment group and control group at 96 weeks of follow-up.,"['maintenance haemodialysis patients', 'maintenance haemodialysis (MHD) patients', 'enrol patients undergoing haemodialysis who has the Montreal Cognitive Assessment score lower than 26 to treatment group', 'patients with MHD']","['placebo', 'thiamine combined with folic acid supplementation', 'thiamine and folic acid', 'Thiamine and folic acid', 'thiamine 90 mg/day combined with folic acid 30 mg/day) or control group (thiamine placebo 90 mg/day combined with folic acid placebo']","['cognitive impairment', 'cognitive function', ""comparison of Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) score"", 'serum thiamine, folate, homocysteine levels, cranial functional MRI and survival']","[{'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.315185,The primary endpoint is the comparison of Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) score between treatment group and control group at 96 weeks of follow-up.,"[{'ForeName': 'Renhua', 'Initials': 'R', 'LastName': 'Lu', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Le-Yi', 'Initials': 'LY', 'LastName': 'Gu', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China guleyi@aliyun.com.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yongping', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Nephrology, Shanghai Sixth Peoples Hospital, Shanghai, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Zang', 'Affiliation': 'Department of Nephrology, Shanghai Songjiang District Central Hospital, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Clinical Center for Investigation, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Huihua', 'Initials': 'H', 'LastName': 'Pang', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Shang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Kewei', 'Initials': 'K', 'LastName': 'Xie', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}]",BMJ open,['10.1136/bmjopen-2021-050605']
1454,34907021,Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults with ADPKD: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


Clinical manifestations of autosomal dominant polycystic kidney disease (ADPKD), including evidence of vascular dysfunction, can begin in childhood. Curcumin is a polyphenol found in turmeric that reduces vascular dysfunction in rodent models and humans without ADPKD. It also slows kidney cystic progression in a murine model of ADPKD. We hypothesized that oral curcumin therapy would reduce vascular endothelial dysfunction and arterial stiffness in children/young adults with ADPKD.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


In a randomized, placebo-controlled, double-blind trial, 68 children/young adults 6-25 years of age with ADPKD and eGFR>80 ml/min per 1.73 m 2  were randomized to either curcumin supplementation (25 mg/kg body weight per day) or placebo administered in powder form for 12 months. The coprimary outcomes were brachial artery flow-mediated dilation and aortic pulse-wave velocity. We also assessed change in circulating/urine biomarkers of oxidative stress/inflammation and kidney growth (height-adjusted total kidney volume) by magnetic resonance imaging. In a subgroup of participants ≥18 years, vascular oxidative stress was measured as the change in brachial artery flow-mediated dilation following an acute infusion of ascorbic acid.
RESULTS


Enrolled participants were 18±5 (mean ± SD) years, 54% were girls, baseline brachial artery flow-mediated dilation was 9.3±4.1% change, and baseline aortic pulse-wave velocity was 512±94 cm/s. Fifty-seven participants completed the trial. Neither coprimary end point changed with curcumin (estimated change [95% confidence interval] for brachial artery flow-mediated dilation [percentage change]: curcumin: 1.14; 95% confidence interval, -0.84 to 3.13; placebo: 0.33; 95% confidence interval, -1.34 to 2.00; estimated difference for change: 0.81; 95% confidence interval, -1.21 to 2.84;  P =0.48; aortic pulse-wave velocity [centimeters per second]: curcumin: 0.6; 95% confidence interval, -25.7 to 26.9; placebo: 6.5; 95% confidence interval, -20.4 to 33.5; estimated difference for change: -5.9; 95% confidence interval, -35.8 to 24.0;  P =0.67; intent to treat). There was no curcumin-specific reduction in vascular oxidative stress or changes in mechanistic biomarkers. Height-adjusted total kidney volume also did not change as compared with placebo.
CONCLUSIONS


Curcumin supplementation does not improve vascular function or slow kidney growth in children/young adults with ADPKD.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults with ADPKD, NCT02494141.
PODCAST


This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2022_02_07_CJN08950621.mp3.",2022,"Neither co-primary endpoint changed with curcumin (estimated change [95% confidence interval] for FMD BA  (% change): curcumin: 1.14 [-0.84, 3.13]; placebo: 0.33","['80 mL/min/1.73 m 2', 'children/young adults with ADPKD', 'Enrolled participants were 18±5 [mean±s.d', '68 children/ young adults 6-25 years of age with ADPKD and an estimated glomerular filtration rate', 'Fifty-seven participants completed the trial', 'Children and Young Adults with ADPKD']","['placebo', 'Curcumin Therapy', 'curcumin supplementation', 'Curcumin supplementation', 'oral curcumin therapy']","['FMD BA', 'brachial artery flow-mediated dilation [FMD BA ] and aortic pulse-wave velocity [aPWV', 'curcumin', 'kidney cystic progression', 'vascular function or slow kidney growth', 'circulating/urine biomarkers of oxidative stress/inflammation and kidney growth (height-adjusted total kidney volume', 'vascular oxidative stress', 'Height-adjusted total kidney volume', 'vascular endothelial dysfunction and arterial stiffness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}]",68.0,0.561915,"Neither co-primary endpoint changed with curcumin (estimated change [95% confidence interval] for FMD BA  (% change): curcumin: 1.14 [-0.84, 3.13]; placebo: 0.33","[{'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Nowak', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado Kristen.Nowak@cuanschutz.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Farmer-Bailey', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'You', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Cortney', 'Initials': 'C', 'LastName': 'Steele', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Cadnapaphornchai', 'Affiliation': ""Rocky Mountain Pediatric Kidney Center, Rocky Mountain Hospital for Children at Presbyterian St. Luke's Medical Center, Denver, Colorado.""}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Klawitter', 'Affiliation': 'Department of Anesthesiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Nayana', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Department of Radiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'George', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jovanovich', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Soranno', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Berenice', 'Initials': 'B', 'LastName': 'Gitomer', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.08950621']
1455,34907435,Effect of acupuncture and metformin on insulin sensitivity in women with polycystic ovary syndrome and insulin resistance: a three-armed randomized controlled trial.,"STUDY QUESTION


Does acupuncture improve insulin sensitivity more effectively than metformin or sham acupuncture in women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)?
SUMMARY ANSWER


Among women with PCOS and IR, acupuncture was not more effective than metformin or sham acupuncture in improving insulin sensitivity.
WHAT IS KNOWN ALREADY


Uncontrolled trials have shown that acupuncture improved insulin sensitivity with fewer side effects compared with metformin in women with PCOS and IR. However, data from randomized trials between acupuncture and metformin or sham acupuncture are lacking.
STUDY DESIGN, SIZE, DURATION


This was a three-armed randomized controlled trial enrolling a total of 342 women with PCOS and IR from three hospitals between November 2015 and February 2018, with a 3-month follow-up until October 2018.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Women aged from 18 to 40 years with PCOS and homeostasis model assessment of insulin resistance (HOMA-IR) ≥2.14 were randomly assigned (n = 114 per group) to receive true acupuncture plus placebo (true acupuncture), metformin plus sham acupuncture (metformin, 0.5 g three times daily) or sham acupuncture plus placebo (sham acupuncture) for 4 months, with an additional 3-month follow-up. True or sham acupuncture was given three times per week, and 0.5 g metformin or placebo was given three times daily. The primary outcome was change in HOMA-IR from baseline to 4 months after baseline visit. Secondary outcomes included changes in the glucose AUC during an oral glucose tolerance test, BMI and side effects at 4 months after baseline visit.
MAIN RESULTS AND THE ROLE OF CHANCE


After 4 months of treatment, the changes of HOMA-IR were -0.5 (decreased 14.7%) in the true acupuncture group, -1.0 (decreased 25.0%) in the metformin group and -0.3 (decreased 8.6%) in the sham acupuncture group, when compared with baseline. True acupuncture is not as effective as metformin in improving HOMA-IR at 4 months after baseline visit (difference, 0.6; 95% CI, 0.1-1.1). No significant difference was found in change in HOMA-IR between true and sham acupuncture groups at 4 months after baseline visit (difference, -0.2; 95% CI, -0.7 to 0.3). During the 4 months of treatment, gastrointestinal side effects were more frequent in the metformin group, including diarrhea, nausea, loss of appetite, fatigue, vomiting and stomach discomfort (31.6%, 13.2%, 11.4%, 8.8%, 14.0% and 8.8%, respectively). Bruising was more common in the true acupuncture group (14.9%).
LIMITATIONS, REASONS FOR CAUTION


This study might have underestimated the sample size in the true acupuncture group with 4 months of treatment to enable detection of statistically significant changes in HOMA-IR with fixed acupuncture (i.e. a non-personalized protocol). Participants who withdrew because of pregnancy did not have further blood tests and this can introduce bias.
WIDER IMPLICATIONS OF THE FINDINGS


True acupuncture did not improve insulin sensitivity as effectively as metformin in women with PCOS and IR, but it is better than metformin in improving glucose metabolism (which might reduce the risk of type 2 diabetes) and has less side effects. Metformin had a higher incidence of gastrointestinal adverse effects than acupuncture groups, and thus acupuncture might be a non-pharmacological treatment with low risk for women with PCOS. Further studies are needed to evaluate the effect of acupuncture combined with metformin on insulin sensitivity in these women.
STUDY FUNDING/COMPETING INTEREST(S)


This work was supported by grants 2017A020213004 and 2014A020221060 from the Science and Technology Planning Project of Guangdong Province. The authors have no conflicts of interest.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov number: NCT02491333.
TRIAL REGISTRATION DATE


8 July 2015.
DATE OF FIRST PATIENT’S ENROLLMENT


11 November 2015.",2022,"No significant difference was found in change in HOMA-IR between true and sham acupuncture groups at 4 months after baseline visit (difference, -0.2; 95% CI, -0.7 to 0.3).","['342 women with PCOS and IR from three hospitals between November 2015 and February 2018, with a 3-month follow-up until October 2018', 'women with PCOS and IR', 'women with polycystic ovary syndrome (PCOS) and insulin resistance (IR', 'women with polycystic ovary syndrome and insulin resistance', '’S', 'Women aged from 18 to 40 years with PCOS and homeostasis model assessment of insulin resistance (HOMA-IR', 'women with PCOS']","['metformin', 'acupuncture', 'sham acupuncture', 'true acupuncture plus placebo (true acupuncture), metformin plus sham acupuncture (metformin, 0.5 g three times daily) or sham acupuncture plus placebo (sham acupuncture', 'metformin or sham acupuncture', 'acupuncture and metformin', 'Metformin', 'acupuncture combined with metformin', 'metformin or placebo']","['HOMA-IR', 'gastrointestinal adverse effects', 'change in HOMA-IR', 'changes of HOMA-IR', 'Bruising', 'changes in the glucose AUC during an oral glucose tolerance test, BMI and side effects', 'insulin sensitivity', 'diarrhea, nausea, loss of appetite, fatigue, vomiting and stomach discomfort', 'gastrointestinal side effects']","[{'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0235309', 'cui_str': 'Upset stomach'}]",342.0,0.776074,"No significant difference was found in change in HOMA-IR between true and sham acupuncture groups at 4 months after baseline visit (difference, -0.2; 95% CI, -0.7 to 0.3).","[{'ForeName': 'Qidan', 'Initials': 'Q', 'LastName': 'Wen', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Maohua', 'Initials': 'M', 'LastName': 'Lai', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhenxing', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Department of Gynecology, Xuzhou Maternity and Child Health Care Hospital, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Kewei', 'Initials': 'K', 'LastName': 'Quan', 'Affiliation': 'Department of Obstetrics and Gynecology, Dongguan Hospital of Traditional Chinese Medicine, Dongguan, Guangdong, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yanbing', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'Department of Traditional Chinese Medicine, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Suling', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional Chinese Medicine, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chuyi', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shuna', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shiya', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Traditional Chinese Medicine, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xingyan', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Lingjing', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhefen', 'Initials': 'Z', 'LastName': 'Mai', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chunren', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Taixiang', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Chinese Clinical Trial Registry, Shenzhen, China.'}, {'ForeName': 'Ernest H Y', 'Initials': 'EHY', 'LastName': 'Ng', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Stener-Victorin', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deab272']
1456,34910206,Low-dose mepolizumab is effective as an add-on therapy for treating long-lasting peripheral neuropathy in patients with eosinophilic granulomatosis with polyangiitis.,"OBJECTIVE


To assess the effectiveness of low-dose mepolizumab as an add-on therapy for treating peripheral neurological symptoms in eosinophilic granulomatosis with polyangiitis (EGPA).
METHODS


We prospectively studied 13 EGPA patients with conventional treatment-resistant peripheral neuropathy. Their symptoms (pain, numbness, and muscle weakness) were assessed on a visual analogue scale (VAS) before and after 12 months of mepolizumab therapy (100 mg every 4 weeks). Peripheral eosinophil levels and several biomarkers including urinary levels of eosinophil-derived neurotoxin (EDN) were measured before and after therapy.
RESULTS


VAS scores for pain and numbness significantly improved after 12 months of mepolizumab therapy (from 67.0 to 48.0, P = 0.012, and from 67.0 to 51.0, P = 0.017, respectively). However, the VAS score for muscle weakness did not improve (P = 0.36). There were significant correlations between treatment-related changes in urinary EDN levels from baseline to 6 months later and percent changes in the VAS scores of pain and numbness (r = 0.75, P = 0.020; r = 0.88, P = 0.002).
CONCLUSIONS


Treatment-resistant peripheral neuropathy in EGPA was significantly improved by low-dose mepolizumab, and effectiveness was correlated with decreased urinary EDN. Because the possibility of a placebo effect cannot be formally excluded, placebo-controlled studies will be required in the future.",2022,"Peripheral eosinophil levels and several biomarkers including urinary levels of eosinophil-derived neurotoxin (EDN) were measured before and after therapy.
","['13 EGPA patients with conventional treatment-resistant peripheral neuropathy', 'patients with eosinophilic granulomatosis with polyangiitis', 'eosinophilic granulomatosis with polyangiitis (EGPA']","['low-dose mepolizumab', 'mepolizumab therapy']","['Peripheral eosinophil levels and several biomarkers including urinary levels of eosinophil-derived neurotoxin (EDN', 'VAS scores of pain and numbness', 'symptoms (pain, numbness, and muscle weakness', 'VAS scores for pain and numbness', 'urinary EDN levels', 'VAS score for muscle weakness', 'visual analogue scale (VAS']","[{'cui': 'C0008728', 'cui_str': 'Eosinophilic granulomatosis with polyangiitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0059409', 'cui_str': 'Eosinophil Protein X'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",13.0,0.0283418,"Peripheral eosinophil levels and several biomarkers including urinary levels of eosinophil-derived neurotoxin (EDN) were measured before and after therapy.
","[{'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Yuma', 'Initials': 'Y', 'LastName': 'Fukutomi', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Sekiya', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Kajiwara', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Fujita', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Kisako', 'Initials': 'K', 'LastName': 'Nagayama', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Iwata', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Iwamoto', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Yano', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Hamada', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Watai', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Ryu', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Kamide', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Taniguchi', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}]",Modern rheumatology,['10.1093/mr/roab005']
1457,34910203,Efficacy and safety of filgotinib alone and in combination with methotrexate in Japanese patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: Subpopulation analyses of 24-week data of a global phase 3 study (FINCH 3).,"OBJECTIVES


To evaluate the efficacy and safety of filgotinib for Japanese patients with rheumatoid arthritis (RA) and limited or no prior methotrexate (MTX) exposure.
METHODS


Data up to 24 weeks were analysed for 71 Japanese patients from a 52-week global Phase 3 study. Patients with RA and limited or no prior MTX exposure were randomised in a 2:1:1:2 ratio to filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg, or MTX. Maximum MTX dose was 15 mg/week. Primary endpoint was proportion achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 24.
RESULTS


Week 24 ACR20 rates in Japanese patients were 82.6%, 90.9%, 83.3%, and 80.0% for filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg, and MTX, respectively. Greater ACR20 rates with filgotinib vs MTX occurred at Week 2. Greater proportions receiving filgotinib vs MTX achieved DAS28-CRP <2.6 at Weeks 12 and 24. Adverse event rates were comparable across treatments and between the Japanese and overall populations.
CONCLUSIONS


While Week 24 ACR20 rates were similar, filgotinib provided faster responses and higher remission rates vs MTX. In Japanese patients with RA and limited or no prior MTX exposure, filgotinib was generally well tolerated.",2022,Greater proportions receiving filgotinib vs MTX achieved DAS28-CRP <2.6 at Weeks 12 and 24.,"['Japanese patients with active rheumatoid arthritis and limited or no prior exposure to', 'Japanese patients with RA', 'Japanese patients with rheumatoid arthritis (RA) and limited or no prior methotrexate (MTX) exposure', 'Data up to 24\u2009weeks were analysed for 71 Japanese patients from a 52-week global Phase 3 study', 'Japanese patients', 'Patients with RA and limited or no prior MTX exposure']","['filgotinib 200\u2009mg plus MTX, filgotinib 100\u2009mg plus MTX, filgotinib 200\u2009mg, or MTX', 'Maximum MTX', 'filgotinib vs MTX', 'methotrexate', 'filgotinib', 'filgotinib alone and in combination with methotrexate', 'MTX']","['Efficacy and safety', 'Greater ACR20 rates', 'ACR20 rates', 'efficacy and safety', 'tolerated', 'proportion achieving 20% improvement in American College of Rheumatology criteria (ACR20', 'Adverse event rates', 'remission rates']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",71.0,0.164405,Greater proportions receiving filgotinib vs MTX achieved DAS28-CRP <2.6 at Weeks 12 and 24.,"[{'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Matsubara', 'Affiliation': 'Department of Orthopedics, Matsubara Mayflower Hospital, 944-25 Fujita, Kato, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Amano', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Hidaka, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ishiguro', 'Affiliation': ''}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Yamaoka', 'Affiliation': 'Department of Rheumatology and Infectious Diseases, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Westhovens', 'Affiliation': 'Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, Division of Rheumatology, University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Daniel W T', 'Initials': 'DWT', 'LastName': 'Ching', 'Affiliation': 'Timaru Medical Specialists Limited, South Canterbury, New Zealand.'}, {'ForeName': 'Osvaldo Daniel', 'Initials': 'OD', 'LastName': 'Messina', 'Affiliation': 'Investigaciones Reumatologicas y Osteologicas SRL IRO, Buenos Aires, Argentina.'}, {'ForeName': 'Gerd R', 'Initials': 'GR', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Free University and Humboldt University, Berlin, Germany.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Bartok', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA, USA.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Pechonkina', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA, USA.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kondo', 'Affiliation': 'Gilead Sciences K.K., Tokyo, Japan.'}, {'ForeName': 'Zhaoyu', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA, USA.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Tasset', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Sundy', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA, USA.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}]",Modern rheumatology,['10.1093/mr/roab021']
1458,34863358,"Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial.","BACKGROUND


Few data exist on the comparative safety and immunogenicity of different COVID-19 vaccines given as a third (booster) dose. To generate data to optimise selection of booster vaccines, we investigated the reactogenicity and immunogenicity of seven different COVID-19 vaccines as a third dose after two doses of ChAdOx1 nCov-19 (Oxford-AstraZeneca; hereafter referred to as ChAd) or BNT162b2 (Pfizer-BioNtech, hearafter referred to as BNT).
METHODS


COV-BOOST is a multicentre, randomised, controlled, phase 2 trial of third dose booster vaccination against COVID-19. Participants were aged older than 30 years, and were at least 70 days post two doses of ChAd or at least 84 days post two doses of BNT primary COVID-19 immunisation course, with no history of laboratory-confirmed SARS-CoV-2 infection. 18 sites were split into three groups (A, B, and C). Within each site group (A, B, or C), participants were randomly assigned to an experimental vaccine or control. Group A received NVX-CoV2373 (Novavax; hereafter referred to as NVX), a half dose of NVX, ChAd, or quadrivalent meningococcal conjugate vaccine (MenACWY)control (1:1:1:1). Group B received BNT, VLA2001 (Valneva; hereafter referred to as VLA), a half dose of VLA, Ad26.COV2.S (Janssen; hereafter referred to as Ad26) or MenACWY (1:1:1:1:1). Group C received mRNA1273 (Moderna; hereafter referred to as m1273), CVnCov (CureVac; hereafter referred to as CVn), a half dose of BNT, or MenACWY (1:1:1:1). Participants and all investigatory staff were blinded to treatment allocation. Coprimary outcomes were safety and reactogenicity and immunogenicity of anti-spike IgG measured by ELISA. The primary analysis for immunogenicity was on a modified intention-to-treat basis; safety and reactogenicity were assessed in the intention-to-treat population. Secondary outcomes included assessment of viral neutralisation and cellular responses. This trial is registered with ISRCTN, number 73765130.
FINDINGS


Between June 1 and June 30, 2021, 3498 people were screened. 2878 participants met eligibility criteria and received COVID-19 vaccine or control. The median ages of ChAd/ChAd-primed participants were 53 years (IQR 44-61) in the younger age group and 76 years (73-78) in the older age group. In the BNT/BNT-primed participants, the median ages were 51 years (41-59) in the younger age group and 78 years (75-82) in the older age group. In the ChAd/ChAD-primed group, 676 (46·7%) participants were female and 1380 (95·4%) were White, and in the BNT/BNT-primed group 770 (53·6%) participants were female and 1321 (91·9%) were White. Three vaccines showed overall increased reactogenicity: m1273 after ChAd/ChAd or BNT/BNT; and ChAd and Ad26 after BNT/BNT. For ChAd/ChAd-primed individuals, spike IgG geometric mean ratios (GMRs) between study vaccines and controls ranged from 1·8 (99% CI 1·5-2·3) in the half VLA group to 32·3 (24·8-42·0) in the m1273 group. GMRs for wild-type cellular responses compared with controls ranged from 1·1 (95% CI 0·7-1·6) for ChAd to 3·6 (2·4-5·5) for m1273. For BNT/BNT-primed individuals, spike IgG GMRs ranged from 1·3 (99% CI 1·0-1·5) in the half VLA group to 11·5 (9·4-14·1) in the m1273 group. GMRs for wild-type cellular responses compared with controls ranged from 1·0 (95% CI 0·7-1·6) for half VLA to 4·7 (3·1-7·1) for m1273. The results were similar between those aged 30-69 years and those aged 70 years and older. Fatigue and pain were the most common solicited local and systemic adverse events, experienced more in people aged 30-69 years than those aged 70 years or older. Serious adverse events were uncommon, similar in active vaccine and control groups. In total, there were 24 serious adverse events: five in the control group (two in control group A, three in control group B, and zero in control group C), two in Ad26, five in VLA, one in VLA-half, one in BNT, two in BNT-half, two in ChAd, one in CVn, two in NVX, two in NVX-half, and one in m1273.
INTERPRETATION


All study vaccines boosted antibody and neutralising responses after ChAd/ChAd initial course and all except one after BNT/BNT, with no safety concerns. Substantial differences in humoral and cellular responses, and vaccine availability will influence policy choices for booster vaccination.
FUNDING


UK Vaccine Taskforce and National Institute for Health Research.",2021,Three vaccines showed overall increased reactogenicity: m1273 after ChAd/ChAd or BNT/BNT; and ChAd and Ad26 after BNT/BNT.,"['Between June 1 and June 30, 2021, 3498 people were screened', 'The median ages of ChAd/ChAd-primed participants were 53 years (IQR 44-61) in the younger age group and 76 years (73-78) in the older age group', 'median ages were 51 years (41-59) in the younger age group and 78 years (75-82) in the older age group', 'Participants were aged older than 30 years', 'aged 30-69 years and those aged 70 years and older', '676 (46·7%) participants were female and 1380 (95·4%) were White, and in the BNT/BNT-primed group 770 (53·6%) participants were female and 1321 (91·9%) were White', 'people aged 30-69 years than those aged 70 years or older', '2878 participants met eligibility criteria and received']","['experimental vaccine or control', 'NVX-CoV2373 (Novavax; hereafter referred to as NVX), a half dose of NVX, ChAd, or quadrivalent meningococcal conjugate vaccine (MenACWY)control (1:1:1:1', 'seven COVID-19 vaccines', 'mRNA1273 (Moderna; hereafter referred to as m1273), CVnCov (CureVac; hereafter referred to as CVn', 'COVID-19 vaccine or control', 'BNT, VLA2001 (Valneva; hereafter referred to as VLA']","['reactogenicity', 'Fatigue and pain', 'Safety and immunogenicity', 'reactogenicity and immunogenicity', 'spike IgG geometric mean ratios (GMRs', 'modified intention-to-treat basis; safety and reactogenicity', 'assessment of viral neutralisation and cellular responses', 'safety and reactogenicity and immunogenicity of anti-spike IgG measured by ELISA', 'serious adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007928', 'cui_str': 'Chad'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517873', 'cui_str': '770'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0007928', 'cui_str': 'Chad'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",3498.0,0.27522,Three vaccines showed overall increased reactogenicity: m1273 after ChAd/ChAd or BNT/BNT; and ChAd and Ad26 after BNT/BNT.,"[{'ForeName': 'Alasdair P S', 'Initials': 'APS', 'LastName': 'Munro', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cornelius', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Parvinder K', 'Initials': 'PK', 'LastName': 'Aley', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Babbage', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baxter', 'Affiliation': 'Stockport NHS Foundation Trust, Stockport, UK.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Bula', 'Affiliation': 'NIHR Liverpool and Broadgreen Clinical Research Facility, Liverpool, UK.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Cathie', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Chatterjee', 'Affiliation': 'NIHR Cambridge Clinical Research Facility, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Dodd', 'Affiliation': 'NIHR Liverpool and Broadgreen Clinical Research Facility, Liverpool, UK.'}, {'ForeName': 'Yvanne', 'Initials': 'Y', 'LastName': 'Enever', 'Affiliation': 'PHARMExcel, Welwyn Garden City, Hertfordshire, UK.'}, {'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Gokani', 'Affiliation': 'NIHR/Wellcome Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Goodman', 'Affiliation': ""Department of Infection, Guy's and St Thomas' NHS Foundation Trust, London, UK; MRC Clinical Trials Unit, University College London, London, UK.""}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Green', 'Affiliation': 'NIHR/Wellcome Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Harndahl', 'Affiliation': 'Portsmouth Hospitals University NHS Trust, Portsmouth, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Haughney', 'Affiliation': 'Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde, Glasgow, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hicks', 'Affiliation': 'Portsmouth Hospitals University NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Agatha A', 'Initials': 'AA', 'LastName': 'van der Klaauw', 'Affiliation': 'Wellcome-MRC Institute of Metabolic Science, Department of Clinical Biochemistry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Kwok', 'Affiliation': 'Cancer Research UK Oxford Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Libri', 'Affiliation': 'NIHR UCLH Clinical Research Facility and NIHR UCLH Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Llewelyn', 'Affiliation': 'University Hospitals Sussex NHS Foundation Trust, Brighton, UK.'}, {'ForeName': 'Alastair C', 'Initials': 'AC', 'LastName': 'McGregor', 'Affiliation': 'Department of Infectious Diseases and Tropical Medicine, London Northwest University Healthcare, London, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Minassian', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Moore', 'Affiliation': 'The Adam Practice, Poole, UK.'}, {'ForeName': 'Mehmood', 'Initials': 'M', 'LastName': 'Mughal', 'Affiliation': 'Stockport NHS Foundation Trust, Stockport, UK.'}, {'ForeName': 'Yama F', 'Initials': 'YF', 'LastName': 'Mujadidi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Murira', 'Affiliation': 'NIHR Leeds Clinical Research Facility, Leeds Teaching Hospitals Trust and University of Leeds, Leeds, UK.'}, {'ForeName': 'Orod', 'Initials': 'O', 'LastName': 'Osanlou', 'Affiliation': 'North Wales Clinical Research Facility, Betsi Cadwaladr University Health Board and Bangor University, Bangor, UK.'}, {'ForeName': 'Rostam', 'Initials': 'R', 'LastName': 'Osanlou', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Owens', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Pacurar', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Palfreeman', 'Affiliation': 'University Hospitals of Leicester NHS Trust, University of Leicester, Leicester, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pan', 'Affiliation': 'University Hospitals of Leicester NHS Trust, University of Leicester, Leicester, UK.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Rampling', 'Affiliation': 'NIHR UCLH Clinical Research Facility and NIHR UCLH Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Regan', 'Affiliation': 'Bradford Institute for Health Research and Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Saich', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salkeld', 'Affiliation': ""Department of Infection, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Saralaya', 'Affiliation': 'Bradford Institute for Health Research and Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'University Hospitals Sussex NHS Foundation Trust, Brighton, UK.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Sheridan', 'Affiliation': 'Royal Devon and Exeter Hospital NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Sturdy', 'Affiliation': 'Department of Infectious Diseases and Tropical Medicine, London Northwest University Healthcare, London, UK.'}, {'ForeName': 'Emma C', 'Initials': 'EC', 'LastName': 'Thomson', 'Affiliation': 'Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde, Glasgow, UK; MRC University of Glasgow Centre for Virus Research, Glasgow, UK.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Todd', 'Affiliation': 'Royal Devon and Exeter Hospital NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Twelves', 'Affiliation': 'NIHR Leeds Clinical Research Facility, Leeds Teaching Hospitals Trust and University of Leeds, Leeds, UK.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Read', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Charlton', 'Affiliation': 'UK Health Security Agency, Porton Down, UK.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Hallis', 'Affiliation': 'UK Health Security Agency, Porton Down, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ramsay', 'Affiliation': 'UK Health Security Agency, Colindale, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Andrews', 'Affiliation': 'UK Health Security Agency, Colindale, London, UK.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Nguyen-Van-Tam', 'Affiliation': 'Division of Epidemiology and Public Health, University of Nottingham School of Medicine, Nottingham, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Xinxue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK. Electronic address: s.faust@soton.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)02717-3']
1459,34910280,Clinical Experience with Ropeginterferon Alfa-2b in the Off-Label Use for the Treatment of COVID-19 Patients in Taiwan.,"INTRODUCTION


This study, for the first time to our knowledge, evaluated the efficacy of ropeginterferon alfa-2b, a long-acting pegylated interferon (IFN)-alfa, in the treatment of COVID-19.
METHODS


We retrospectively evaluated ropeginterferon alfa-2b administered subcutaneously at a single dose of 250 µg for the treatment of mild and moderate COVID-19. Primary outcome was to compare the overall negative conversion time from the confirmed, last positive SARS-CoV-2 RT-PCR to the first RT-PCR negative conversion between patients receiving ropeginterferon alfa-2b plus standard of care (SOC) and those receiving SOC alone.
RESULTS


Thirty-five patients with mild COVID-19 and 37 patients with moderate disease were included. Of them, 19 patients received SOC plus ropeginterferon alfa-2b and 53 patients received SOC alone. All patients with moderate disease in the ropeginterferon alfa-2b group showed RT-PCR negative conversion within 8 days, while a significant portion of patients in the SOC alone group failed to do so. For patients with moderate disease and age ≤ 65 years old, the ropeginterferon alfa-2b group had statistically significant shorter median RT-PCR conversion time than the SOC alone group (7 vs. 11.5 days, p < 0.05).
CONCLUSIONS


Ropeginterferon alfa-2b showed the potential for the treatment of moderate COVID-19 patients. A randomized, controlled Phase III study is planned to further assess the effectiveness of ropeginterferon alfa-2b in COVID-19 patients.",2022,"All patients with moderate disease in the ropeginterferon alfa-2b group showed RT-PCR negative conversion within 8 days, while a significant portion of patients in the SOC alone group failed to do so.","['COVID-19 patients', 'COVID-19 Patients in Taiwan', 'moderate COVID-19 patients', 'Thirty-five patients with mild COVID-19 and 37 patients with moderate disease were included']","['ropeginterferon alfa-2b, a long-acting pegylated interferon (IFN)-alfa', 'ropeginterferon alfa-2b plus standard of care (SOC', 'SOC plus ropeginterferon alfa-2b', 'ropeginterferon alfa-2b', 'Ropeginterferon Alfa-2b', 'SOC alone']","['median RT-PCR conversion time', 'overall negative conversion time from the confirmed, last positive SARS-CoV-2 RT-PCR to the first RT-PCR negative conversion', 'RT-PCR negative conversion']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",35.0,0.0385887,"All patients with moderate disease in the ropeginterferon alfa-2b group showed RT-PCR negative conversion within 8 days, while a significant portion of patients in the SOC alone group failed to do so.","[{'ForeName': 'Kuan-Yuan', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Kang-Yun', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Qin', 'Affiliation': 'PharmaEssentia Corporation, Taipei, Taiwan.'}, {'ForeName': 'Ching-Shan', 'Initials': 'CS', 'LastName': 'Luo', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yun-Kai', 'Initials': 'YK', 'LastName': 'Yeh', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Jing-Quan', 'Initials': 'JQ', 'LastName': 'Zheng', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Ching-Mei', 'Initials': 'CM', 'LastName': 'Chen', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Chan-Yen', 'Initials': 'CY', 'LastName': 'Tsai', 'Affiliation': 'PharmaEssentia Corporation, Taipei, Taiwan.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'PharmaEssentia Corporation, Taipei, Taiwan.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'PharmaEssentia Corporation, Taipei, Taiwan.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Huang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Po-Hao', 'Initials': 'PH', 'LastName': 'Feng', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. pohao.feng@gmail.com.'}]",Advances in therapy,['10.1007/s12325-021-01998-y']
1460,34911035,Sleep Deprivation Training to Reduce the Negative Effects of Sleep Loss on Endurance Performance: A Single Case Study.,"PURPOSE


Sleep deprivation (SD) is very common during ultraendurance competitions. At present, stimulants such as caffeine and naps are the main strategies used to reduce the negative effects of SD on ultraendurance performance. In this case study, the authors describe the application of a novel strategy consisting of the intermittent repetition of SD (SD training [SDT]) during the weeks preceding an ultraendurance competition.
METHODS


A male ultraendurance runner underwent a 6-week SDT program (consisting of 1 night SD every Sunday) in addition to his regular physical training program before taking part in a 6-day race. Before and after SDT, the participant performed 5 consecutive days of daily 2-hour constant-pace running with SD on the first and third night. Psychological and physiological responses were measured during this multiday test.
RESULTS


SDT was well tolerated by the athlete. A visual analysis of the data suggests that including SDT in the weeks preceding an ultraendurance competition may have beneficial effects on sleepiness and perceived mental effort in the context of 5 consecutive days of prolonged running and 2 nights of SD. This multiday test seems a feasible way for assessing ultraendurance athletes in the laboratory.
CONCLUSIONS


The results provided some encouraging initial information about SDT that needs to be confirmed in a randomized controlled trial in a group of ultraendurance athletes. If confirmed to be effective and well tolerated, SDT might be used in the future to help ultraendurance athletes and other populations that have to perform in conditions of SD.",2021,A visual analysis of the data suggests that including SDT in the weeks preceding an ultraendurance competition may have beneficial effects on sleepiness and perceived mental effort in the context of 5 consecutive days of prolonged running and 2 nights of SD.,['A male ultraendurance runner underwent a 6-week'],"['SDT program (consisting of 1 night SD every Sunday) in addition to his regular physical training program', 'intermittent repetition of SD (SD training [SDT', 'Sleep Deprivation Training']",['Psychological and physiological responses'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C3887446', 'cui_str': 'Every Sunday'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",,0.0437101,A visual analysis of the data suggests that including SDT in the weeks preceding an ultraendurance competition may have beneficial effects on sleepiness and perceived mental effort in the context of 5 consecutive days of prolonged running and 2 nights of SD.,"[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Gattoni', 'Affiliation': ''}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Girardi', 'Affiliation': ''}, {'ForeName': 'Barry Vincent', 'Initials': 'BV', 'LastName': ""O'Neill"", 'Affiliation': ''}, {'ForeName': 'Samuele', 'Initials': 'S', 'LastName': 'Maria Marcora', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2021-0230']
1461,34923559,Infusion Reactions After Receiving the Broadly Neutralizing Antibody VRC01 or Placebo to Reduce HIV-1 Acquisition: Results From the Phase 2b Antibody-Mediated Prevention Randomized Trials.,"BACKGROUND


The antibody-mediated prevention (AMP) studies (HVTN 703/HPTN 081 and HVTN 704/HPTN 085) are harmonized phase 2b trials to assess HIV prevention efficacy and safety of intravenous infusion of anti-gp120 broadly neutralizing antibody VRC01. Antibodies for other indications can elicit infusion-related reactions (IRRs), often requiring premedication and limiting their application. We report on AMP study IRRs.
METHODS


From 2016 to 2018, 2699 HIV-uninfected, at-risk men and transgender adults in the Americas and Switzerland (704/085) and 1924 at-risk heterosexual women in sub-Saharan Africa (703/081) were randomized 1:1:1 to VRC01 10 mg/kg, 30 mg/kg, or placebo. Participants received infusions every 8 weeks (n = 10/participant) over 72 weeks, with 104 weeks of follow-up. Safety assessments were conducted before and after infusion and at noninfusion visits. A total of 40,674 infusions were administered.
RESULTS


Forty-seven participants (1.7%) experienced 49 IRRs in 704/085; 93 (4.8%) experienced 111 IRRs in 703/081 (P < 0.001). IRRs occurred more frequently in VRC01 than placebo recipients in 703/081 (P < 0.001). IRRs were associated with atopic history (P = 0.046) and with younger age (P = 0.023) in 703/081. Four clinical phenotypes of IRRs were observed: urticaria, dyspnea, dyspnea with rash, and ""other."" Urticaria was most prevalent, occurring in 25 (0.9%) participants in 704/085 and 41 (2.1%) participants in 703/081. Most IRRs occurred with the initial infusion and incidence diminished through the last infusion. All reactions were managed successfully without sequelae.
CONCLUSIONS


IRRs in the AMP studies were uncommon, typically mild or moderate, successfully managed at the research clinic, and resolved without sequelae. Analysis is ongoing to explore potential IRR mechanisms.",2022,"Urticaria was most prevalent, occurring in 25 (0.9%) participants in 704/085 and 41 (2.1%) participants in 703/081.","['From 2016-2018, 2,699 HIV-uninfected, at-risk men and transgender adults in the Americas and Switzerland (704/085) and 1,901 at-risk heterosexual women in sub-Saharan Africa (703/081']","['placebo', 'VRC01']","['urticaria, dyspnea, dyspnea with rash', 'IRRs', 'HIV-1 acquisition', 'Urticaria']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}]",40674.0,0.361774,"Urticaria was most prevalent, occurring in 25 (0.9%) participants in 704/085 and 41 (2.1%) participants in 703/081.","[{'ForeName': 'Simbarashe', 'Initials': 'S', 'LastName': 'Takuva', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Shelly T', 'Initials': 'ST', 'LastName': 'Karuna', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Juraska', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Rudnicki', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'De La Grecca', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Gaudinski', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sehurutshi', 'Affiliation': 'Botswana Harvard AIDS Institute, Gaborone, Botswana, South Africa.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Orrell', 'Affiliation': 'Department of Medicine, Desmond Tutu HIV Center, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Logashvari', 'Initials': 'L', 'LastName': 'Naidoo', 'Affiliation': 'South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Valencia', 'Affiliation': 'Asociacion Civil Impacta Salud y Educacion, Lima, Peru.'}, {'ForeName': 'Larissa M', 'Initials': 'LM', 'LastName': 'Villela', 'Affiliation': 'Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz (INI-Fiocruz), Rio de Janeiro, Brazil.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Andrew', 'Affiliation': 'Family Health International, Durham, NC.'}, {'ForeName': 'Carissa', 'Initials': 'C', 'LastName': 'Karg', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Randhawa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hural', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Margarita M', 'Initials': 'MM', 'LastName': 'Gomez Lorenzo', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Burns', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ledgerwood', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Myron', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Mngadi', 'Affiliation': 'Aurum Institute, Johannesburg, South Africa; and.'}, {'ForeName': 'Nyaradzo M', 'Initials': 'NM', 'LastName': 'Mgodi', 'Affiliation': 'University of Zimbabwe Clinical Trials Research Center, Harare, Zimbabwe.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002892']
1462,34924173,Outcome of early versus delayed invasive strategy in patients with non-ST-segment elevation myocardial infarction and chronic kidney disease not on dialysis.,"BACKGROUND AND AIMS


Because of paucity of published data, we evaluated the 2-year major clinical outcomes between early invasive (EI) and delayed invasive (DI) strategies according to the stage of chronic kidney disease (CKD) in patients with non-ST-segment elevation myocardial infarction (NSTEMI), who underwent a successful newer-generation drug-eluting stent (DES) implantation.
METHODS


A total of 8241 NSTEMI patients were recruited from the Korea Acute Myocardial Infarction Registry (KAMIR). Based on baseline estimated glomerular filtration rate (eGFR; ≥90, 60-89, 30-59, and <30 mL/min/1.73 m 2 ), the patients were classified into groups A (n = 3498), B (n = 3109), C (n = 1178), and D (n = 1178). Thereafter, these 4 groups were sub-classified into the EI and DI groups. Major adverse cardiac events (MACE), defined as all-cause death, recurrent MI (re-MI), and any repeat revascularization, were evaluated.
RESULTS


After multivariable-adjusted and propensity score-adjusted analyses, the cumulative incidence of MACE (group A, p = 0.139 and p = 0.103, respectively; group B, p = 0.968 and p = 0.608, respectively; group C, p = 0.111 and p = 0.196, respectively; group D, p = 0.882 and p = 0.571, respectively), all-cause death, re-MI, and any repeat revascularization was similar between the EI and DI groups in the 4 different renal function groups.
CONCLUSIONS


In the era of newer-generation DES, EI and DI strategies showed comparable major clinical outcomes in patients with NSTEMI and CKD during a 2-year follow-up period. However, to confirm these results, further randomized, large-scale, long-term follow-up studies are needed.",2022,"In the era of newer-generation DES, EI and DI strategies showed comparable major clinical outcomes in patients with NSTEMI and CKD during a 2-year follow-up period.","['patients with non-ST-segment elevation myocardial infarction and chronic kidney disease not on dialysis', 'A total of 8241 NSTEMI patients were recruited from the Korea Acute Myocardial Infarction Registry (KAMIR', 'patients with non-ST-segment elevation myocardial infarction (NSTEMI), who underwent a successful newer-generation drug-eluting stent (DES) implantation']",['early invasive (EI) and delayed invasive (DI) strategies'],"['Major adverse cardiac events (MACE), defined as all-cause death, recurrent MI (re-MI), and any repeat revascularization', 'cause death, re-MI, and any repeat revascularization', 'cumulative incidence of MACE', 'glomerular filtration rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",8241.0,0.0417011,"In the era of newer-generation DES, EI and DI strategies showed comparable major clinical outcomes in patients with NSTEMI and CKD during a 2-year follow-up period.","[{'ForeName': 'Yong Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, Republic of Korea. Electronic address: yhkim02@kangwon.ac.kr.'}, {'ForeName': 'Ae-Young', 'Initials': 'AY', 'LastName': 'Her', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Myung Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Chonnam National University Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Jun', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Department of Cardiology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Atherosclerosis,['10.1016/j.atherosclerosis.2021.11.024']
1463,34694761,Antibiotics versus Appendectomy for Acute Appendicitis - Longer-Term Outcomes.,,2021,,[],['Antibiotics versus Appendectomy'],[],[],"[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}]",[],,0.0628688,,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Giana H', 'Initials': 'GH', 'LastName': 'Davidson', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Flum', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Monsell', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Lillian S', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Voldal', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Fannon', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Danielle C', 'Initials': 'DC', 'LastName': 'Lavallee', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Bizzell', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Sarah O', 'Initials': 'SO', 'LastName': 'Lawrence', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Comstock', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'Krishnadasan', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Winchell', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Callie M', 'Initials': 'CM', 'LastName': 'Thompson', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Farhood', 'Initials': 'F', 'LastName': 'Farjah', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Pauline K', 'Initials': 'PK', 'LastName': 'Park', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Hasan B', 'Initials': 'HB', 'LastName': 'Alam', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Darin', 'Initials': 'D', 'LastName': 'Saltzman', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Moran', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Amy H', 'Initials': 'AH', 'LastName': 'Kaji', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'DeUgarte', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Salzberg', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ferrigno', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Mandell', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Thea P', 'Initials': 'TP', 'LastName': 'Price', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Siparsky', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Glaser', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ayoung-Chee', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chiang', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Victory', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Chung', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Damien W', 'Initials': 'DW', 'LastName': 'Carter', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Kutcher', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Holihan', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Mike K', 'Initials': 'MK', 'LastName': 'Liang', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Brett A', 'Initials': 'BA', 'LastName': 'Faine', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cuschieri', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Evans', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Joe H', 'Initials': 'JH', 'LastName': 'Patton', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Coleman', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fischkoff', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'F Thurston', 'Initials': 'FT', 'LastName': 'Drake', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Sabrina E', 'Initials': 'SE', 'LastName': 'Sanchez', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Parsons', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Odom', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'Larry G', 'Initials': 'LG', 'LastName': 'Kessler', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Talan', 'Affiliation': 'From University of Washington Medical Center-UW Medicine (G.H.D., D.R.F., E.F., D.C.L., B.B., S.O.L., F.F., L.G.K.), University of Washington (S.E.M., E.C.V., P.J.H., B.A.C.), Swedish Medical Center (K.A.M.), and Harborview Medical Center-UW Medicine (J.C., H.L.E.), Seattle, and Providence Regional Medical Center, Everett (J.G.) - all in Washington; McGovern Medical School, University of Texas Health Science Center (L.S.K.), Lyndon B. Johnson General Hospital,\xa0University of Texas (J.H., M.K.L.), and HCA Healthcare Kingwood, University of Houston (M.K.L.) - all in Houston; BC Academic Science Health Network, Vancouver, BC, Canada (D.C.L.); Olive View-UCLA Medical Center (A.K., D.S., G.J.M., D.A.T.), Harbor-UCLA Medical Center (A.H.K., D.A.D.), and UCLA Ronald Reagan Medical Center (D.A.T.), Los Angeles, and the University of California, San Francisco (J.C.) - all in California; Weill Cornell Medical Center (R.J.W.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C., J.V.), Bellevue Hospital Center, NYU School of Medicine (W.C.), and Columbia University Medical Center (N.C., K.F.) - all in New York; Vanderbilt University Medical Center, Nashville (W.H.S., C.M.T.); University of Utah, Salt Lake City (C.M.T.); University of Michigan Medical Center, Ann Arbor (P.K.P., H.B.A.), and Henry Ford Health System, Detroit (J.J., J.H.P.) - both in Michigan; UCHealth, University of Colorado Hospital, Denver (M.S., L.F.); Rush University Medical Center, Chicago (T.P.P., N.S.); Morehouse School of Medicine, Atlanta (P.A.-C.); Maine Medical Center, Portland (B.C., D.W.C.); University of Mississippi Medical Center, Jackson (M.E.K., A.J.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F.); Medical University of South Carolina, Charleston (H.L.E.); and Boston University Medical Center (F.T.D., S.E.S.) and Beth Israel Deaconess Medical Center (C.P., S.R.O.) - both in Boston.'}]",The New England journal of medicine,['10.1056/NEJMc2116018']
1464,34862302,The heart & mind trial: intervention with cognitive-behavioural therapy in patients with cardiac disease and anxiety: randomised controlled trial protocol.,"INTRODUCTION


Patients with cardiac disease often experience anxiety (prevalence about 20%-25%) and have a doubled mortality risk when suffering from anxiety compared with patients without anxiety. This calls for interventions aiming to reduce anxiety.
METHODS AND ANALYSIS


The Heart & Mind Trial consists of three parts: (1) screening of all hospitalised and outpatient cardiac patients with arrhythmia, heart failure or ischaemic heart disease at four university hospitals in Denmark using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A); Patients scoring ≥8 is invited to participate; (2) Assessment of the type of anxiety by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders and (3) Randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive-behavioural therapy (CBT) performed by a CBT-trained cardiac nurse plus usual care or, usual care alone. The primary outcome is anxiety measured with HADS-A at 5 months. Secondary outcomes include anxiety symptoms measured with Becks Anxiety Inventory and heart rate variability. Exploratory outcomes measured at 12 months include blood cortisol (stress response), blood C reactive protein (stress response), health-related quality of life, readmission, mortality and attributable direct costs. A total of 336 patients will be included. The primary analyses are based on the intention-to-treat principle. For the primary outcome, we will use a linear regression model. For the long-term outcomes, mixed regression models will be used including repeated measurements.
ETHICS AND DISSEMINATION


The trial is performed in accordance with the Declaration of Helsinki. All patients must give informed consent prior to participation and the trial is initiated after approval by the Danish Data Protection Agency (P-2020-894) and the National Committee on Health Research Ethics (H-20066739). Positive, neutral and negative results of the trial will be published.
TRIAL REGISTRATION NUMBER


NCT04582734.",2021,"Exploratory outcomes measured at 12 months include blood cortisol (stress response), blood C reactive protein (stress response), health-related quality of life, readmission, mortality and attributable direct costs.","['336 patients will be included', 'patients with cardiac disease and anxiety', 'outpatient cardiac patients with arrhythmia, heart failure or ischaemic heart disease at four university hospitals in Denmark using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A); Patients scoring ≥8 is invited to participate']","['CBT-trained cardiac nurse plus usual care or, usual care alone', 'cognitive-behavioural therapy (CBT', 'cognitive-behavioural therapy']","['blood cortisol (stress response), blood C reactive protein (stress response), health-related quality of life, readmission, mortality and attributable direct costs', 'anxiety symptoms measured with Becks Anxiety Inventory and heart rate variability', 'anxiety measured with HADS-A at 5 months']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C3887625', 'cui_str': 'Coronary care nurse'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0853179', 'cui_str': 'Blood cortisol'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",336.0,0.101049,"Exploratory outcomes measured at 12 months include blood cortisol (stress response), blood C reactive protein (stress response), health-related quality of life, readmission, mortality and attributable direct costs.","[{'ForeName': 'Selina Kikkenborg', 'Initials': 'SK', 'LastName': 'Berg', 'Affiliation': 'The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen O, 2100, Denmark selina@rh.dk.'}, {'ForeName': 'Margrethe', 'Initials': 'M', 'LastName': 'Herning', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Hellerup, 2900, Denmark.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Schjødt', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, 8200, Denmark.'}, {'ForeName': 'Charlotte Brun', 'Initials': 'CB', 'LastName': 'Thorup', 'Affiliation': 'Clinical Nursing Research Unit and Department of Cardiology, Aalborg University Hospital, Aalborg, 9000, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Juul', 'Affiliation': 'Psychological consulting, Heypeople, Copenhagen K, 1260, Denmark.'}, {'ForeName': 'Jesper Hastrup', 'Initials': 'JH', 'LastName': 'Svendsen', 'Affiliation': 'The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen O, 2100, Denmark.'}, {'ForeName': 'Martin Balslev', 'Initials': 'MB', 'LastName': 'Jorgensen', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen N, 2200, Denmark.'}, {'ForeName': 'Signe Stelling', 'Initials': 'SS', 'LastName': 'Risom', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen N, 2200, Denmark.'}, {'ForeName': 'Signe Westh', 'Initials': 'SW', 'LastName': 'Christensen', 'Affiliation': 'The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen O, 2100, Denmark.'}, {'ForeName': 'Lau', 'Initials': 'L', 'LastName': 'Thygesen', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen K, 1455, Denmark.'}, {'ForeName': 'Trine Bernholdt', 'Initials': 'TB', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen N, 2200, Denmark.'}]",BMJ open,['10.1136/bmjopen-2021-057085']
1465,34921662,"Pharmacokinetics, Safety, and Tolerability of a Medicinal Cannabis Formulation in Patients with Chronic Non-cancer Pain on Long-Term High Dose Opioid Analgesia: A Pilot Study.","INTRODUCTION


This phase I open-label study examined pharmacokinetics, safety, and tolerability of escalating doses of a novel combination cannabinoid medication (1:1 tetrahydrocannabinol [THC]/cannabidiol [CBD]) in patients with chronic non-cancer pain (CNCP) on high dose opioid analgesia.
METHODS


Nine people with CNCP and oral morphine equivalent daily dose of 60 mg or higher were recruited. Blood concentrations of THC, 11-hydroxytetrahydrocannabinol (OH-THC), 11-nor-9-carboxy-tetrahydrocannabinol (COOH-THC), and CBD were assayed weekly. Concentrations were measured after a single dose of 2.5 mg THC/2.5 mg CBD on day 1, and daily escalating doses up to a single dose of 12.5 mg THC/12.5 mg CBD on day 29. Follow-up was on day 36 after a 7-day washout. Secondary outcome data encompassed pain, mood, and sleep parameters.
RESULTS


The parent compounds THC, and CBD, and metabolites OH-THC and COOH-THC were detected at most time points. In general, the concentration of all analytes increased until 2 h post-administration, decreasing to approximately pre-dose concentrations by 8 h. There was considerable inter- and intra-individual variability. The study medication was well tolerated. Eight participants reported at least one adverse event (AE), with a total of 62 AEs; most common were euphoric mood, headache, and agitation, none classified as severe. There was no significant change to pain severity self-ratings, nor use of pain medications. Improvements in pain interference scores, mood, and some sleep parameters were observed.
CONCLUSION


The THC/CBD formulation was tolerated well in a group of patients with CNCP. Between-participant variability supports personalized dosing and ""start low-go slow"" titration. To validate and quantify improvements in secondary efficacy outcomes a randomized placebo-controlled study is needed.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Register (CT-2019-CTN-01224-1).",2022,"Blood concentrations of THC, 11-hydroxytetrahydrocannabinol","['Patients with Chronic Non-cancer Pain on Long-Term High Dose Opioid Analgesia', 'patients with chronic non-cancer pain (CNCP) on high dose opioid analgesia', 'Nine people with CNCP and oral morphine equivalent daily dose of 60\xa0mg or higher were recruited']","['placebo', 'Medicinal Cannabis Formulation', 'novel combination cannabinoid medication (1:1 tetrahydrocannabinol [THC]/cannabidiol [CBD']","['Pharmacokinetics, Safety, and Tolerability', 'pain severity self-ratings, nor use of pain medications', 'pharmacokinetics, safety, and tolerability', 'tolerated', 'Blood concentrations of THC, 11-hydroxytetrahydrocannabinol', 'OH-THC), 11-nor-9-carboxy-tetrahydrocannabinol (COOH-THC), and CBD', 'THC, and CBD, and metabolites OH-THC and COOH-THC', 'euphoric mood, headache, and agitation', 'pain interference scores, mood, and some sleep parameters', 'pain, mood, and sleep parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0813973', 'cui_str': 'Medical Cannabis'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0044747', 'cui_str': '11-hydroxy-delta(9)-tetrahydrocannabinol'}, {'cui': 'C0368839', 'cui_str': 'Carboxy tetrahydrocannabinol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",9.0,0.138609,"Blood concentrations of THC, 11-hydroxytetrahydrocannabinol","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bonomo', 'Affiliation': ""Department of Addiction Medicine, St Vincent's Hospital Melbourne, University of Melbourne, P.O. Box 2900, Fitzroy, VIC, 3065, Australia. Yvonne.bonomo@svha.org.au.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Norman', 'Affiliation': ""Department of Addiction Medicine, St Vincent's Hospital Melbourne, P.O. Box 2900, Fitzroy, VIC, 3065, Australia.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Collins', 'Affiliation': ""Department of Addiction Medicine, St Vincent's Hospital Melbourne, P.O. Box 2900, Fitzroy, VIC, 3065, Australia.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': ""O'Neill"", 'Affiliation': ""Department of Addiction Medicine, St Vincent's Hospital Melbourne, P.O. Box 2900, Fitzroy, VIC, 3065, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Galettis', 'Affiliation': 'Clinical Pharmacology Laboratory, Faculty of Health and Medicine, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Trinca', 'Affiliation': ""Barbara Walker Centre for Pain Management, St Vincent's Hospital Melbourne, P.O. Box 2900, Fitzroy, VIC, 3065, Australia.""}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Strauss', 'Affiliation': 'Millswyn Clinic, 466 Punt Road, South Yarra, VIC, 3141, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Castle', 'Affiliation': ""Mental Health, St Vincent's Hospital Melbourne, University of Melbourne, P.O. Box 2900, Fitzroy, VIC, 3065, Australia.""}]",Pain and therapy,['10.1007/s40122-021-00344-y']
1466,34933755,"Re: Luke Harper, T. Blanc, M. Peycelon, et al. Circumcision and Risk of Febrile Urinary Tract Infection in Boys with Posterior Urethral Valves: Result of the CIRCUP Randomized Trial. Eur Urol. 2022;81:64-72.",,2022,,['Boys with Posterior Urethral Valves'],[],[],"[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0238506', 'cui_str': 'Congenital posterior urethral valves'}]",[],[],,0.0942457,,"[{'ForeName': 'Deepansh', 'Initials': 'D', 'LastName': 'Dalela', 'Affiliation': ""Children's Hospital of Michigan, Detroit, MI, USA; Department of Urology, Henry Ford Hospital, Detroit, MI, USA. Electronic address: ddalela1@hfhs.org.""}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Suson', 'Affiliation': ""Children's Hospital of Michigan, Detroit, MI, USA; Department of Urology, Henry Ford Hospital, Detroit, MI, USA.""}]",European urology,['10.1016/j.eururo.2021.11.031']
1467,34873002,Economic evaluation of an Australian nurse home visiting programme: a randomised trial at 3 years.,"OBJECTIVES


To investigate the additional programme cost and cost-effectiveness of 'right@home' Nurse Home Visiting (NHV) programme in relation to improving maternal and child outcomes at child age 3 years compared with usual care.
DESIGN


A cost-utility analysis from a government-as-payer perspective alongside a randomised trial of NHV over 3-year period. Costs and quality-adjusted life-years (QALYs) were discounted at 5%. Analysis used an intention-to-treat approach with multiple imputation.
SETTING


The right@home was implemented from 2013 in Victoria and Tasmania states of Australia, as a primary care service for pregnant women, delivered until child age 2 years.
PARTICIPANTS


722 pregnant Australian women experiencing adversity received NHV (n=363) or usual care (clinic visits) (n=359).
PRIMARY AND SECONDARY OUTCOME MEASURES


First, a cost-consequences analysis to compare the additional costs of NHV over usual care, accounting for any reduced costs of service use, and impacts on all maternal and child outcomes assessed at 3 years. Second, cost-utility analysis from a government-as-payer perspective compared additional costs to maternal QALYs to express cost-effectiveness in terms of additional cost per additional QALY gained.
RESULTS


When compared with usual care at child age 3 years, the right@home intervention cost $A7685 extra per woman (95% CI $A7006 to $A8364) and generated 0.01 more QALYs (95% CI -0.01 to 0.02). The probability of right@home being cost-effective by child age 3 years is less than 20%, at a willingness-to-pay threshold of $A50 000 per QALY.
CONCLUSIONS


Benefits of NHV to parenting at 2 years and maternal health and well-being at 3 years translate into marginal maternal QALY gains. Like previous cost-effectiveness results for NHV programmes, right@home is not cost-effective at 3 years. Given the relatively high up-front costs of NHV, long-term follow-up is needed to assess the accrual of health and economic benefits over time.
TRIAL REGISTRATION NUMBER


ISRCTN89962120.",2021,"When compared with usual care at child age 3 years, the right@home intervention cost $A7685 extra per woman (95% CI $A7006 to $A8364) and generated 0.01 more QALYs (95% CI -0.01 to 0.02).","['Australian nurse home visiting programme', 'The right@home was implemented from 2013 in Victoria and Tasmania states of Australia, as a primary care service for pregnant women, delivered until child age 2 years', '722 pregnant Australian women experiencing adversity received NHV (n=363) or usual care (clinic visits) (n=359']","[""right@home' Nurse Home Visiting (NHV) programme""]","['probability of right@home being cost-effective', 'Costs and quality-adjusted life-years (QALYs', 'right@home intervention cost']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0039335', 'cui_str': 'Tasmania'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.044047,"When compared with usual care at child age 3 years, the right@home intervention cost $A7685 extra per woman (95% CI $A7006 to $A8364) and generated 0.01 more QALYs (95% CI -0.01 to 0.02).","[{'ForeName': 'Shalika', 'Initials': 'S', 'LastName': 'Bohingamu Mudiyanselage', 'Affiliation': 'School of Health and Social Development, Deakin University, Burwood, VIC, 3125, Australia shalika.b@deakin.edu.au.'}, {'ForeName': 'Anna M H', 'Initials': 'AMH', 'LastName': 'Price', 'Affiliation': ""Population Health, Murdoch Children's Research Institute, Parkville, VIC, 3052, Australia.""}, {'ForeName': 'Fiona K', 'Initials': 'FK', 'LastName': 'Mensah', 'Affiliation': ""Population Health, Murdoch Children's Research Institute, Parkville, VIC, 3052, Australia.""}, {'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Bryson', 'Affiliation': ""Population Health, Murdoch Children's Research Institute, Parkville, VIC, 3052, Australia.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Perlen', 'Affiliation': ""Population Health, Murdoch Children's Research Institute, Parkville, VIC, 3052, Australia.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Orsini', 'Affiliation': ""Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, The Royal Children's Hospital, Melbourne, VIC, 3052, Australia.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hiscock', 'Affiliation': ""Centre for Community Child Health, The Royal Children's Hospital, Parkville, VIC, 3052, Australia.""}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Dakin', 'Affiliation': 'Australian Research Alliance for Children and Youth, Canberra City, ACT, 2601, Australia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Harris', 'Affiliation': 'Australian Research Alliance for Children and Youth, Canberra City, ACT, 2601, Australia.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Noble', 'Affiliation': 'Australian Research Alliance for Children and Youth, Canberra City, ACT, 2601, Australia.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Bruce', 'Affiliation': 'Ingham Institute, Western Sydney University, Penrith, NSW, 2751, Australia.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Kemp', 'Affiliation': 'Ingham Institute, Western Sydney University, Penrith, NSW, 2751, Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Goldfeld', 'Affiliation': ""Population Health, Murdoch Children's Research Institute, Parkville, VIC, 3052, Australia.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gold', 'Affiliation': 'School of Health and Social Development, Deakin University, Burwood, VIC, 3125, Australia.'}]",BMJ open,['10.1136/bmjopen-2021-052156']
1468,34939119,Peer-Delivery of a Gender-Specific Smoking Cessation Intervention for Women Living in Disadvantaged Communities in Ireland We Can Quit2 (WCQ2)-A Pilot Cluster Randomized Controlled Trial.,"INTRODUCTION


We Can Quit"" (WCQ) is community-based stop-smoking program delivered by trained community facilitators, based on the socio-ecological framework and developed using a Community-based Participatory Research approach, targeting women living in socioeconomically disadvantaged (SED) areas of Ireland.
AIMS AND METHODS


The We Can Quit2 (WCQ2) pilot trial assessed the feasibility of WCQ. A pragmatic cluster randomized controlled trial with a process evaluation WCQ2, was conducted in four matched pairs of SED districts (8-10 000 women per district). Districts were independently randomized to WCQ (group support + nicotine replacement therapy), or to individual support delivered by health professionals. Participants were adult women smokers interested in quitting, who were living or working in trial districts. Recruitment of districts and 194 women in four waves (49 women per wave); retention at 12 weeks and 6 months; fidelity to intervention delivery and acceptability of trial-related processes were assessed. Validated smoking abstinence at 12-week and 6-month post-intervention was recorded, missing data assumed as continued smoking.
RESULTS


Eight districts were recruited. 125/188 (66.5%) eligible women consented. The 49 women target was reached in wave4. Retention at 12 weeks was (Intervention [I]: 55.4%; Control [C]: 51.7%), at 6 months (I: 47.7%; C: 46.7%). Smoking abstinence at 12 weeks was (I: 23.1%, [95% CI: 14.5 to 34.7]; C: 13%, [95% CI: 6.9 to 24.1]). 83.8% of session activities were delivered. Trial-related processes were acceptable to facilitators. Low literacy was highlighted as a barrier for participants' acceptability.
CONCLUSIONS


WCQ was feasible to deliver by trained facilitators and indicated a positive direction in abstinence rates. Low literacy will need to be addressed in a future trial design.
IMPLICATIONS


This pilot trial showed that a stop-smoking intervention tailored to a group of women smokers living in SED areas which was delivered by trained local women within their local communities was feasible. Furthermore, although not formally compared, more WCQ women were abstinent from smoking at the end of treatment. The results are relevant to enhance the design of a fully powered effectiveness trial, and provide important evidence on the barriers to deliver a tailored smoking cessation service to SED women smokers in Ireland.",2022,"Smoking abstinence at 12 weeks was (I: 23.1%, [95% CI: 14.5 to 34.7]; C: 13%, [95% CI: 6.9 to 24.1]).","['125/188 (66.5%) eligible women consented', 'women smokers living in SED areas which was delivered by trained local women within their local communities was feasible', '49 women target was reached in wave4', 'women living in socioeconomically disadvantaged (SED) areas of Ireland', 'Eight districts were recruited', 'Participants were adult women smokers interested in quitting, who were living or working in trial districts', 'four matched pairs of SED districts (8-10 000 women per district', 'Women Living in Disadvantaged Communities in Ireland', 'SED women smokers in Ireland', 'Recruitment of districts and 194 women in four waves (49 women per wave); retention at 12 weeks and 6 months']","['WCQ', 'Quit"" (WCQ', 'Peer-Delivery of a Gender-Specific Smoking Cessation Intervention', 'WCQ (group support + nicotine replacement therapy), or to individual support delivered by health professionals']","['Smoking abstinence', 'fidelity to intervention delivery and acceptability of trial-related processes', 'Validated smoking abstinence']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]",4.0,0.0997668,"Smoking abstinence at 12 weeks was (I: 23.1%, [95% CI: 14.5 to 34.7]; C: 13%, [95% CI: 6.9 to 24.1]).","[{'ForeName': 'Catherine B', 'Initials': 'CB', 'LastName': 'Hayes', 'Affiliation': 'Public Health and Primary Care, Institute of Population Health, School of Medicine, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Patterson', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University, Edinburgh, Scotland.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Castello', 'Affiliation': 'Public Health and Primary Care, Institute of Population Health, School of Medicine, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Burke', 'Affiliation': 'Public Health and Primary Care, Institute of Population Health, School of Medicine, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': ""O'Connell"", 'Affiliation': 'Public Health and Primary Care, Institute of Population Health, School of Medicine, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Catherine D', 'Initials': 'CD', 'LastName': 'Darker', 'Affiliation': 'Public Health and Primary Care, Institute of Population Health, School of Medicine, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bauld', 'Affiliation': 'Usher Institute and SPECTRUM Consortium, College of Medicine and Veterinary Science, University of Edinburgh, Edinburgh, Scotland.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Vance', 'Affiliation': 'Irish Cancer Society, Dublin, Ireland.'}, {'ForeName': 'Aurelia', 'Initials': 'A', 'LastName': 'Ciblis', 'Affiliation': 'Freelance Researcher, Dublin, Ireland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Dobbie', 'Affiliation': 'Usher Institute, College of Medicine and Veterinary Science, University of Edinburgh, Edinburgh, Scotland.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Loudon', 'Affiliation': 'Freelance Researcher, Edinburgh, Scotland.'}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'Devane', 'Affiliation': 'HRB Trials Methodology Research Network, School of Nursing & Midwifery, NUI Galway, Galway, Ireland.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Dougall', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University, Edinburgh, Scotland.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntab242']
1469,34941317,Shared decision-making for youth psychotherapy: A preliminary randomized clinical trial on facilitating personalized treatment.,"OBJECTIVE


Engaging youth and caregivers as active collaborators in the treatment planning process is a patient-centered approach with the potential to facilitate the personalization of established evidence-based treatments. This study is the first randomized clinical trial to evaluate shared decision-making (SDM) to plan youth psychotherapy.
METHOD


Forty youth (7-15 years; 33% ethnic minority) were randomly assigned to psychosocial treatment planned using SDM ( n  = 20) or planned primarily by the clinician ( n  = 20). In the SDM condition, clinicians guided youth and caregivers through a collaborative treatment planning process that relies on research findings to inform three primary decisions: (a) treatment target problem(s), (b) treatment participants, and (c) treatment techniques. Assessments occurred at baseline, following treatment planning, midtreatment, and post-treatment.
RESULTS


Youth and caregivers in the SDM condition reported significantly greater involvement in the treatment planning process compared to their counterparts in the clinician-guided condition ( U  = 123.00,  p  = .037;  U  = 84.50,  p  = .014, respectively) and SDM caregivers reported significantly lower decisional conflict ( U  = 72.00,  p  = .004) and decisional regret ( U  = 73.50,  p  = .020). Supporting the feasibility of successful SDM implementation, there were no significant differences between conditions on treatment length, satisfaction with decisions, or engagement. There were no significant diagnostic or symptom differences between conditions.
CONCLUSIONS


Planning psychosocial treatments in collaboration with youth and caregivers is a promising way to support youth and caregiver autonomy and plan evidence-based treatments that are responsive to patient preferences, culture, and values. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,"Supporting the feasibility of successful SDM implementation, there were no significant differences between conditions on treatment length, satisfaction with decisions, or engagement.",['Forty youth (7-15 years; 33% ethnic minority'],['psychosocial treatment planned using SDM ( n  = 20) or planned primarily by the clinician'],"['decisional regret ', 'treatment length, satisfaction with decisions, or engagement', 'decisional conflict']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}]","[{'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}]",,0.235611,"Supporting the feasibility of successful SDM implementation, there were no significant differences between conditions on treatment length, satisfaction with decisions, or engagement.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Langer', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Lindsay E', 'Initials': 'LE', 'LastName': 'Holly', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Celia E', 'Initials': 'CE', 'LastName': 'Wills', 'Affiliation': 'College of Nursing.'}, {'ForeName': 'Martha C', 'Initials': 'MC', 'LastName': 'Tompson', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Chorpita', 'Affiliation': 'Department of Psychology.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000702']
1470,34949631,"Evaluation of a two-way SMS messaging strategy to reduce neonatal mortality: rationale, design and methods of the Mobile WACh NEO randomised controlled trial in Kenya.","INTRODUCTION


Globally, approximately half of the estimated 6.3 million under-5 deaths occur in the neonatal period (within the first 28 days of life). Kenya ranks among countries with the highest number of neonatal deaths, at 20 per 1000 live births. Improved identification and management of neonates with potentially life-threatening illness is critical to meet the WHO's target of ≤12 neonatal deaths per 1000 live births by 2035. We developed an interactive (two-way) short messaging service (SMS) communication intervention, Mobile Solutions for Neonatal Health (Mobile women's and children's health (WACh) NEO), focused on the perinatal period. Mobile WACh NEO sends automated tailored SMS messages to mothers during pregnancy and up to 6 weeks post partum. Messages employ the Information-Motivation-Behaviour Skills framework to promote (1) maternal implementation of essential newborn care (ENC, including early, exclusive breast feeding, cord care and thermal care), (2) maternal identification of neonatal danger signs and care-seeking, and (3) maternal social support and self-efficacy. Participants can also send SMS to the study nurse, enabling on-demand remote support.
METHODS AND ANALYSIS


We describe a two-arm unblinded randomised controlled trial of the Mobile WACh NEO intervention. We will enrol 5000 pregnant women in the third trimester of pregnancy at 4 facilities in Kenya and randomise them 1:1 to receive interactive SMS or no SMS (control), and conduct follow-up visits at 2 and 6 weeks post partum. Neonatal mortality will be compared between arms as the primary outcome. Secondary outcomes include care-seeking, practice of ENC and psychosocial health. Exploratory analysis will investigate associations between maternal mental health, practice of ENC, care-seeking and SMS engagement.
ETHICS AND DISSEMINATION


This study received ethical approval from the University of Washington (STUDY00006395), Women and Infants Hospital (1755292-1) and Kenyatta National Hospital/University of Nairobi (P310/04/2019). All participants will provide written informed consent. Findings will be published in peer-reviewed journals and international conferences.
TRIAL REGISTRATION NUMBER


NCT04598165.",2021,"We developed an interactive (two-way) short messaging service (SMS) communication intervention, Mobile Solutions for Neonatal Health","['Kenya', 'University of Washington (STUDY00006395), Women and Infants Hospital (1755292-1) and Kenyatta National Hospital/University of Nairobi (P310/04/2019', ""Mobile women's and children's health (WACh) NEO), focused on the perinatal period"", '5000 pregnant women in the third trimester of pregnancy at 4 facilities in Kenya and randomise them 1:1 to receive', 'Kenya ranks among countries with the highest number of neonatal deaths, at 20 per 1000 live births']","['interactive (two-way) short messaging service (SMS) communication intervention, Mobile Solutions for Neonatal Health', 'interactive SMS or no SMS (control', 'Mobile WACh NEO intervention']","['care-seeking, practice of ENC and psychosocial health', 'Neonatal mortality', 'neonatal mortality']","[{'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4042838', 'cui_str': 'Neonatal Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}]",5000.0,0.10165,"We developed an interactive (two-way) short messaging service (SMS) communication intervention, Mobile Solutions for Neonatal Health","[{'ForeName': 'Keshet', 'Initials': 'K', 'LastName': 'Ronen', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA keshet@uw.edu.'}, {'ForeName': 'Esther M', 'Initials': 'EM', 'LastName': 'Choo', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Wandika', 'Affiliation': 'Department of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Jenna I', 'Initials': 'JI', 'LastName': 'Udren', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Lusi', 'Initials': 'L', 'LastName': 'Osborn', 'Affiliation': 'Department of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Peninah', 'Initials': 'P', 'LastName': 'Kithao', 'Affiliation': 'Department of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Anna B', 'Initials': 'AB', 'LastName': 'Hedstrom', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Millicent', 'Initials': 'M', 'LastName': 'Masinde', 'Affiliation': 'Department of Obstetrics and Gynecology, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Manasi', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Psychiatry, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Dalton C', 'Initials': 'DC', 'LastName': 'Wamalwa', 'Affiliation': 'Department of Pediatrics and Child Health, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Barbra A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': 'Department of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Unger', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA.'}]",BMJ open,['10.1136/bmjopen-2021-056062']
1471,34950442,Effect of Different Anesthesia Methods on Emergence Agitation and Related Complications in Postoperative Patients with Osteosarcoma.,"Purpose


To explore the effect of different anesthesia methods on emergence agitation (EA) and related complications in postoperative patients with osteosarcoma.
Methods


According to the order of admission, 115 patients requiring osteosarcoma surgery treated in our hospital from January 2018 to December 2020 were selected as the research object and randomly divided into the control group ( n  = 57, accepted the general anesthesia with tracheal intubation) and the experimental group ( n  = 58, accepted the combined spinal-epidural anesthesia) to compare their anesthesia effect, incidence rates of agitation and complications, and other indexes.
Results


In terms of the hemodynamic indexes (MAP, HR, and CVP values), both groups had lower ones at  T   1  than at  T   0 , but the decline of the experimental group was generally lesser than that of the control group; at  T   2 , no statistical difference was shown within the experimental group's indexes when comparing with those at  T   1 , but the control group obtained a significant increase; at  T   3  and  T   4 , both groups had their hemodynamic indexes increased, but such increase within the experimental group showed no statistical difference when comparing with those at  T   0 , while the control group achieved obviously higher values at  T   4  than at  T   0  (before the anesthesia); and the between-group difference in the hemodynamic indexes at  T   1  and  T   4  was significant. Compared with the control group, the experimental group achieved better VAS scores and anesthesia indexes and lower incidence rates of EA and complications such as the hypoxemia, cardiovascular response, delayed recovery, and headache. In addition, the differences in the incidence rates of hypotension and cognitive dysfunction between the two groups were not statistically significant.
Conclusion


When comparing with tracheal intubation general anesthesia, the combined spinal-epidural anesthesia has a better effect in osteosarcoma surgery, with less hemodynamics influence on patients, reduced postoperative pain and stress reaction, and lowered incidence rates of postoperative EA and complications, which is worthy of wide application in clinical treatment.",2021,"Compared with the control group, the experimental group achieved better VAS scores and anesthesia indexes and lower incidence rates of EA and complications such as the hypoxemia, cardiovascular response, delayed recovery, and headache.","['115 patients requiring osteosarcoma surgery treated in our hospital from January 2018 to December 2020', 'Postoperative Patients with Osteosarcoma', 'postoperative patients with osteosarcoma']","['control group ( n \u2009=\u200957, accepted the general anesthesia with tracheal intubation']","['emergence agitation (EA', 'hemodynamic indexes (MAP, HR, and CVP values', 'hemodynamic indexes', 'postoperative pain and stress reaction', 'VAS scores and anesthesia indexes and lower incidence rates of EA and complications such as the hypoxemia, cardiovascular response, delayed recovery, and headache', 'Emergence Agitation and Related Complications', 'incidence rates of hypotension and cognitive dysfunction']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0056633', 'cui_str': 'COP protocol 2'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0016664', 'cui_str': 'Stress fracture'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]",,0.0140117,"Compared with the control group, the experimental group achieved better VAS scores and anesthesia indexes and lower incidence rates of EA and complications such as the hypoxemia, cardiovascular response, delayed recovery, and headache.","[{'ForeName': 'Minghuan', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics,Guanggu Hospital Area, Wuhan Third Hospital, Wuhan 430071, Hubei Province, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology,Guanggu Hospital Area, Wuhan Third Hospital, Wuhan 430071, Hubei Province, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Mao', 'Affiliation': 'Department of Orthopedics,Guanggu Hospital Area, Wuhan Third Hospital, Wuhan 430071, Hubei Province, China.'}]",Journal of healthcare engineering,['10.1155/2021/7120035']
1472,34922298,"Varlitinib plus capecitabine in second-line advanced biliary tract cancer: a randomized, phase II study (TreeTopp).","BACKGROUND


Patients with advanced biliary tract cancer who progress on first-line therapy have limited treatment options. The TreeTopp study assessed varlitinib, a reversible small molecule pan-human epidermal growth factor receptor inhibitor, plus capecitabine in previously treated advanced biliary tract cancer.
PATIENTS AND METHODS


This global, double-blind, randomized, placebo-controlled phase II study enrolled patients with confirmed unresectable or metastatic biliary tract cancer and disease progression after one prior line of gemcitabine-containing chemotherapy. Patients received oral varlitinib 300 mg or placebo twice daily (b.i.d.) for 21 days, plus oral capecitabine 1000 mg/m 2  b.i.d. on days 1-14, in 21-day treatment cycles. Co-primary endpoints were objective response rate and progression-free survival (PFS) according to RECIST v1.1 by Independent Central Review.
RESULTS


In total, 127 patients received varlitinib plus capecitabine (n = 64) or placebo plus capecitabine (n = 63). The objective response rate was 9.4% with varlitinib plus capecitabine versus 4.8% with capecitabine alone (odds ratio 2.28; P = 0.42). Median PFS was 2.83 versus 2.79 months [hazard ratio (HR), 0.90; 95% confidence interval (CI), 0.60-1.37; P = 0.63] and overall survival was 7.8 versus 7.5 months (HR, 1.11; 95% CI, 0.69-1.79; P = 0.66), respectively. In a subgroup analysis, the addition of varlitinib appeared to provide a PFS benefit in female patients (median, 4.1 versus 2.8 months; HR, 0.59; 95% CI, 0.28-1.23) and those with gallbladder cancer (median, 2.9 versus 1.6 months; HR, 0.55; 95% CI, 0.26-1.19). Grade ≥3 treatment-emergent adverse events were reported in 65.6% of patients receiving varlitinib plus capecitabine versus 58.7% of those receiving capecitabine alone.
CONCLUSIONS


In patients with advanced biliary tract cancer, second-line treatment with varlitinib plus capecitabine was well tolerated but did not improve efficacy versus capecitabine alone. A PFS benefit was suggested in female patients and those with gallbladder cancer.",2022,"Median PFS was 2.83 versus 2.79 months [hazard ratio (HR), 0.90; 95% confidence interval (CI), 0.60-1.37; P = 0.63] and overall survival was 7.8 versus 7.5 months (HR, 1.11; 95% CI, 0.69-1.79; P = 0.66), respectively.","['127 patients received', 'second-line advanced biliary tract cancer', 'Patients with advanced biliary tract cancer', 'female patients and those with gallbladder cancer', 'patients with advanced biliary tract cancer', 'enrolled patients with confirmed unresectable or metastatic biliary tract cancer and disease progression after one prior line of', 'previously treated advanced biliary tract cancer']","['placebo', 'varlitinib plus capecitabine', 'placebo plus capecitabine', 'gemcitabine-containing chemotherapy', 'Varlitinib plus capecitabine', 'capecitabine', 'oral varlitinib 300 mg or placebo']","['gallbladder cancer', 'objective response rate', 'overall survival', 'objective response rate and progression-free survival (PFS', 'Grade ≥3 treatment-emergent adverse events', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0153452', 'cui_str': 'Malignant tumor of gallbladder'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0153452', 'cui_str': 'Malignant tumor of gallbladder'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.281003,"Median PFS was 2.83 versus 2.79 months [hazard ratio (HR), 0.90; 95% confidence interval (CI), 0.60-1.37; P = 0.63] and overall survival was 7.8 versus 7.5 months (HR, 1.11; 95% CI, 0.69-1.79; P = 0.66), respectively.","[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Javle', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: mjavle@mdanderson.org.'}, {'ForeName': 'D-Y', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Integrated Major in Innovative Medical Science, Seoul National University Graduate School, Seoul, South Korea.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'W-P', 'Initials': 'WP', 'LastName': 'Yong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, Cancer Science Institute, Singapore, Singapore.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hsu', 'Affiliation': 'ASLAN Pharmaceuticals, Singapore, Singapore.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lindmark', 'Affiliation': 'ASLAN Pharmaceuticals, Singapore, Singapore.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'McIntyre', 'Affiliation': 'ASLAN Pharmaceuticals, Singapore, Singapore.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Firth', 'Affiliation': 'ASLAN Pharmaceuticals, Singapore, Singapore.'}]",ESMO open,['10.1016/j.esmoop.2021.100314']
1473,34896295,The protocol of the Application of Economics & Social psychology to improve Opioid Prescribing Safety trial 2 (AESOPS-2): Availability of opioid harm.,"BACKGROUND


High levels of opioid prescribing in the United States has resulted in an alarming trend in opioid-related harms. The objective of Trial 2 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-2) is to dampen the intensity and frequency of opioid prescribing in accordance with the Centers for Disease Control and Prevention recommendation to ""go low and slow"". We aim to accomplish this by notifying clinicians of harmful patient outcomes, which we expect to increase the mental availability of risks associated with opioid use.
METHODS


The trial is multi-site. Random assignment determines if prescribers to persons who suffer an opioid overdose (fatal or nonfatal) learn of this event (intervention) or practice usual care (control). Clinicians in the intervention group receive a letter notifying them of their patient's overdose. The primary outcome is the change in clinician weekly milligram morphine equivalent (MME) prescribed in a 6-month period before and after receiving the letter. Additional outcomes are the change in the proportion of patients prescribed at least 50 daily MME and in the proportion of patients referred to medication assisted treatment. Group differences in these outcomes will be compared using an intent-to-treat difference-in-differences framework with a mixed-effects regression model to estimate clinician MME.
DISCUSSION


The AESOPS-2 trial will provide new knowledge about whether increasing prescribers' awareness of patients' opioid-related overdoses leads to a reduction in opioid prescribing. Additionally, this trial may better inform how to reduce opioid use disorder and opioid overdoses by lowering population exposure to these drugs.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT04758637.",2022,"The objective of Trial 2 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-2) is to dampen the intensity and frequency of opioid prescribing in accordance with the Centers for Disease Control and Prevention recommendation to ""go low and slow"".",['persons who suffer an opioid overdose (fatal or nonfatal) learn of this event (intervention) or practice usual care (control'],[],['change in clinician weekly milligram morphine equivalent (MME'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]",,0.134801,"The objective of Trial 2 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-2) is to dampen the intensity and frequency of opioid prescribing in accordance with the Centers for Disease Control and Prevention recommendation to ""go low and slow"".","[{'ForeName': 'Marcella A', 'Initials': 'MA', 'LastName': 'Kelley', 'Affiliation': 'Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America; School of Pharmacy, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Persell', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Linder', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Friedberg', 'Affiliation': 'Blue Cross & Blue Shield of Massachusetts, Boston, MA, United States of America.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Meeker', 'Affiliation': 'Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America; Keck School of Medicine, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Fox', 'Affiliation': 'Anderson School of Management, University of California at Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Noah J', 'Initials': 'NJ', 'LastName': 'Goldstein', 'Affiliation': 'Anderson School of Management, University of California at Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Tara K', 'Initials': 'TK', 'LastName': 'Knight', 'Affiliation': 'Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America; Sol Price School of Public Policy, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Zein', 'Affiliation': 'Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Jason N', 'Initials': 'JN', 'LastName': 'Doctor', 'Affiliation': 'Schaeffer Center for Health Economics and Policy, University of Southern California, Los Angeles, CA, United States of America; School of Pharmacy, University of Southern California, Los Angeles, CA, United States of America; Sol Price School of Public Policy, University of Southern California, Los Angeles, CA, United States of America. Electronic address: jdoctor@usc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106650']
1474,34521099,Ibrutinib induces durable remissions in treatment-naïve patients with CLL and 17p deletion and/or TP53 mutations.,,2021,,[],[],['durable remissions'],[],[],"[{'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.0740035,,"[{'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Sivina', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Wierda', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ferrajoli', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Thompson', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Hagop', 'Initials': 'H', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Keating', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Burger', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Blood,['10.1182/blood.2021012315']
1475,34916875,"The Effect of Using Peer on Self-Care, Quality of Life, and Adherence in Elderly People with Coronary Artery Disease.","Introduction


Coronary artery disease is one of the most common diseases and the cause of death among elderly people. Due to the chronic nature of this disease, regular follow-up, lifestyle changes, and adherence to recommendations can reduce the complications and improve the quality of life among elderly individuals. Given the importance of using educational methods that are based on the patient's age and disease stage, the present study aimed to investigate the effect of using a peer group on self-care, adherence, and quality of life in elderly people.
Method


This single-blind clinical trial was conducted on 30 old patients with coronary artery disease aged 60 years in Shiraz from March to June 2021. The patients were selected using simple random sampling and were then randomly assigned to the peer education and control groups (15 participants in each group) via permuted block randomization. The patients in the peer education group received the necessary education about medications, lifestyle, daily activities, self-care, and adherence through three educational clips by educated peer. The patients in the control group received routine education using two clips by the ward nurses. The levels of self-care, adherence, and quality of life were assessed in the intervention and control groups before and one month after the intervention. Data analysis was performed by SPSS 20 software using an independent  t -test, paired sample  t -test, and chi-square test.  P  < 0.05 was considered statistically significant.  Findings . The results showed no statistically significant difference between the two groups with respect to the mean scores of self-care and quality of life before the intervention ( P  > 0.05). Following the educational intervention, however, a statistically significant difference was found between the two groups concerning the mean scores of self-care and adherence ( P  < 0.05). Moreover, the mean differences between the two groups regarding the three variables were statistically significant before and after the intervention ( P  < 0.05).
Conclusion


Education based on multimedia clips by peer was effective in increasing the mean scores of self-care, adherence, and quality of life among the elderly people with coronary artery disease. Given the low cost, high effectiveness, and decrease in the nurses' workload, this method is recommended to be used alongside other methods in order to educate elderly individuals suffering from coronary artery disease.",2021,The results showed no statistically significant difference between the two groups with respect to the mean scores of self-care and quality of life before the intervention ( P  > 0.05).,"['Elderly People with Coronary Artery Disease', '30 old patients with coronary artery disease aged 60 years in Shiraz from March to June 2021', 'elderly people', 'elderly individuals', 'elderly individuals suffering from coronary artery disease', 'elderly people with coronary artery disease']","['necessary education about medications, lifestyle, daily activities, self-care, and adherence through three educational clips by educated peer', 'routine education using two clips by the ward nurses']","['self-care, adherence, and quality of life', 'levels of self-care, adherence, and quality of life', 'mean scores of self-care and adherence', 'mean scores of self-care, adherence, and quality of life', 'Self-Care, Quality of Life, and Adherence', 'quality of life', 'mean scores of self-care and quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.00799593,The results showed no statistically significant difference between the two groups with respect to the mean scores of self-care and quality of life before the intervention ( P  > 0.05).,"[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Roshandel', 'Affiliation': 'School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Rakhshan', 'Affiliation': 'School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Najafi Kalyani', 'Affiliation': 'School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",TheScientificWorldJournal,['10.1155/2021/4770721']
1476,34862289,REinforcement learning to improve non-adherence for diabetes treatments by Optimising Response and Customising Engagement (REINFORCE): study protocol of a pragmatic randomised trial.,"INTRODUCTION


Achieving optimal diabetes control requires several daily self-management behaviours, especially adherence to medication. Evidence supports the use of text messages to support adherence, but there remains much opportunity to improve their effectiveness. One key limitation is that message content has been generic. By contrast, reinforcement learning is a machine learning method that can be used to identify individuals' patterns of responsiveness by observing their response to cues and then optimising them accordingly. Despite its demonstrated benefits outside of healthcare, its application to tailoring communication for patients has received limited attention. The objective of this trial is to test the impact of a reinforcement learning-based text messaging programme on adherence to medication for patients with type 2 diabetes.
METHODS AND ANALYSIS


In the REinforcement learning to Improve Non-adherence For diabetes treatments by Optimising Response and Customising Engagement (REINFORCE) trial, we are randomising 60 patients with suboptimal diabetes control treated with oral diabetes medications to receive a reinforcement learning intervention or control. Subjects in both arms will receive electronic pill bottles to use, and those in the intervention arm will receive up to daily text messages. The messages will be individually adapted using a reinforcement learning prediction algorithm based on daily adherence measurements from the pill bottles. The trial's primary outcome is average adherence to medication over the 6-month follow-up period. Secondary outcomes include diabetes control, measured by glycated haemoglobin A1c, and self-reported adherence. In sum, the REINFORCE trial will evaluate the effect of personalising the framing of text messages for patients to support medication adherence and provide insight into how this could be adapted at scale to improve other self-management interventions.
ETHICS AND DISSEMINATION


This study was approved by the Mass General Brigham Institutional Review Board (IRB) (USA). Findings will be disseminated through peer-reviewed journals, clinicaltrials.gov reporting and conferences.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov (NCT04473326).",2021,"The objective of this trial is to test the impact of a reinforcement learning-based text messaging programme on adherence to medication for patients with type 2 diabetes.
","['60 patients with suboptimal diabetes control treated with oral diabetes medications to receive a', 'patients with type 2 diabetes']","['REinforcement learning', 'reinforcement learning intervention or control', 'reinforcement learning-based text messaging programme', 'electronic pill bottles']","['diabetes control, measured by glycated haemoglobin A1c, and self-reported adherence', 'average adherence to medication']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",60.0,0.0970479,"The objective of this trial is to test the impact of a reinforcement learning-based text messaging programme on adherence to medication for patients with type 2 diabetes.
","[{'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Lauffenburger', 'Affiliation': ""Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA jlauffenburger@bwh.harvard.edu.""}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Yom-Tov', 'Affiliation': 'Microsoft Research, Microsoft, Herzeliya, Israel.'}, {'ForeName': 'Punam A', 'Initials': 'PA', 'LastName': 'Keller', 'Affiliation': 'Tuck School of Business, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Marie E', 'Initials': 'ME', 'LastName': 'McDonnell', 'Affiliation': ""Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Lily G', 'Initials': 'LG', 'LastName': 'Bessette', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Constance P', 'Initials': 'CP', 'LastName': 'Fontanet', 'Affiliation': ""Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ellen S', 'Initials': 'ES', 'LastName': 'Sears', 'Affiliation': ""Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': ""Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Hanken', 'Affiliation': ""Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'J Joseph', 'Initials': 'JJ', 'LastName': 'Buckley', 'Affiliation': ""Division of Sleep Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Renee A', 'Initials': 'RA', 'LastName': 'Barlev', 'Affiliation': ""Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Haff', 'Affiliation': ""Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Niteesh K', 'Initials': 'NK', 'LastName': 'Choudhry', 'Affiliation': ""Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}]",BMJ open,['10.1136/bmjopen-2021-052091']
1477,34922004,The soluble epoxide hydrolase inhibitor GSK2256294 decreases the proportion of adipose pro-inflammatory T cells.,"Adipose tissue contains a complex immune environment and is a central contributor to heightened systemic inflammation in obese persons. Epoxyeicosatrienoic acids (EETs) are lipid signaling molecules that decrease inflammation in obese animals, but their effect on inflammation in humans is unknown. The enzyme soluble epoxide hydrolase (sEH) hydrolyzes EETs to less active diols, and we hypothesized that pharmacologic sEH inhibition would decrease adipose inflammation in obese individuals. We treated obese prediabetic adults with the sEH inhibitor GSK2256294 versus placebo in a crossover design, collected subcutaneous abdominal adipose tissue via lipoaspiration and characterized the tissue T cell profile. Treatment with GSK2256294 decreased the percentage of pro-inflammatory T cells producing interferon-gamma (IFNγ), but not interleukin (IL)-17A, and decreased the amount of secreted tumor necrosis factor-alpha (TNFα). Understanding the contribution of the EET/sEH pathway to inflammation in obesity could lead to new strategies to modulate adipose and systemic inflammation.",2022,"Treatment with GSK2256294 decreased the percentage of pro-inflammatory T cells producing interferon-gamma (IFNγ), but not interleukin (IL)-17A, and decreased the amount of secreted tumor necrosis factor-alpha (TNFα).","['obese prediabetic adults with the', 'obese persons', 'obese individuals']",['sEH inhibitor GSK2256294 versus placebo'],"['percentage of pro-inflammatory T cells producing interferon-gamma (IFNγ), but not interleukin (IL)-17A, and decreased the amount of secreted tumor necrosis factor-alpha (TNFα', 'proportion of adipose pro-inflammatory T cells', 'adipose inflammation']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0014628', 'cui_str': 'Epoxide hydrolase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3713989', 'cui_str': 'GSK2256294'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0519126,"Treatment with GSK2256294 decreased the percentage of pro-inflammatory T cells producing interferon-gamma (IFNγ), but not interleukin (IL)-17A, and decreased the amount of secreted tumor necrosis factor-alpha (TNFα).","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Mashayekhi', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Diabetes, Endocrinology and Metabolism, Nashville, TN, United States. Electronic address: mona.mashayekhi@vumc.org.'}, {'ForeName': 'Celestine N', 'Initials': 'CN', 'LastName': 'Wanjalla', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Infectious Diseases, Nashville, TN, United States.'}, {'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Warren', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Infectious Diseases, Nashville, TN, United States.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Simmons', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Infectious Diseases, Nashville, TN, United States.'}, {'ForeName': 'Kakali', 'Initials': 'K', 'LastName': 'Ghoshal', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Nephrology, Nashville, TN, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pilkinton', 'Affiliation': 'Saint Thomas Hospital West, Nashville, TN, United States.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Bailin', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Infectious Diseases, Nashville, TN, United States.'}, {'ForeName': 'Curtis L', 'Initials': 'CL', 'LastName': 'Gabriel', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Gastroenterology, Hepatology and Nutrition, Nashville, TN, United States.'}, {'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Pozzi', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Nephrology, Nashville, TN, United States; Veterans Affairs Tennessee Valley Healthcare System, Nashville, TN, United States.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Koethe', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Infectious Diseases, Nashville, TN, United States; Veterans Affairs Tennessee Valley Healthcare System, Nashville, TN, United States.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Brown', 'Affiliation': 'Yale School of Medicine, Nashville, TN, United States.'}, {'ForeName': 'Spyros A', 'Initials': 'SA', 'LastName': 'Kalams', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Infectious Diseases, Nashville, TN, United States.'}, {'ForeName': 'J Matthew', 'Initials': 'JM', 'LastName': 'Luther', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Clinical Pharmacology, Nashville, TN, United States.'}]",Prostaglandins & other lipid mediators,['10.1016/j.prostaglandins.2021.106604']
1478,34923285,Cost-Effectiveness Analysis of Etanercept 25 mg Maintenance Therapy After Treatment With Etanercept 50 mg for Moderate Rheumatoid Arthritis in the PRESERVE Trial in Japan.,"OBJECTIVES


To use Markov modeling to estimate the cost-effectiveness of treatment with etanercept 25 mg once weekly plus methotrexate (MTX) in Japanese patients with rheumatoid arthritis who had achieved remission or low disease activity with etanercept 50 mg once weekly plus MTX.
METHODS


Effectiveness data were estimated based on results from a clinical trial (PRESERVE) in patients with rheumatoid arthritis who had achieved remission or low disease activity and who were then randomized to receive etanercept 25 mg plus MTX or placebo plus MTX. A Markov model was established and included flare rates of 21% and 62% in the etanercept 25 mg and placebo groups, respectively. EQ-5D was calculated using an ordinary least-squares model that included the health assessment questionnaire disability index and pain visual analog scale. Worsening of the health assessment questionnaire score over 1 year was estimated to be 0.047 for patients with flare, and when associated with radiographic progression it was estimated to increase by 0.006 and 0.025 in the etanercept 25 mg and placebo groups, respectively. A cycle length of 1 year was applied to calculate the cumulative cost and effectiveness for a 10-year time span.
RESULTS


Compared with the placebo group, the quality-adjusted life-years for the etanercept 25 mg group was increased by 0.841. The incremental cost-effectiveness ratio was ¥6 173 772.
CONCLUSION


These results suggest that maintenance treatment with etanercept 25 mg is cost-effective.",2022,"Worsening of the health assessment questionnaire score over 1 year was estimated to be 0.047 for patients with flare, and when associated with radiographic progression it was estimated to increase by 0.006 and 0.025 in the etanercept 25 mg and placebo groups, respectively.","['patients with rheumatoid arthritis who had achieved remission or low disease activity and who', 'Japanese patients with rheumatoid arthritis who had achieved remission or low disease activity with etanercept 50 mg once weekly plus MTX']","['placebo', 'etanercept 25 mg plus MTX or placebo plus MTX', 'methotrexate (MTX', '25 mg Maintenance Therapy', 'Etanercept', 'etanercept']","['health assessment questionnaire disability index and pain visual analog scale', 'radiographic progression', 'flare rates', 'EQ-5D', 'quality-adjusted life-years', 'Worsening of the health assessment questionnaire score', 'cumulative cost and effectiveness', 'incremental cost-effectiveness ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C2960025', 'cui_str': 'Health assessment questionnaire score'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.144222,"Worsening of the health assessment questionnaire score over 1 year was estimated to be 0.047 for patients with flare, and when associated with radiographic progression it was estimated to increase by 0.006 and 0.025 in the etanercept 25 mg and placebo groups, respectively.","[{'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Hirose', 'Affiliation': 'Immunology & Inflammation Medical Affairs, Pfizer Innovative Health, Pfizer Japan, Tokyo, Japan; Atopy (Allergy) Research Center, Juntendo University School of Medicine, Tokyo, Japan. Electronic address: tomohiro.hirose@pfizer.com.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Kawaguchi', 'Affiliation': 'Immunology & Inflammation Medical Affairs, Pfizer Innovative Health, Pfizer Japan, Tokyo, Japan.'}, {'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Murata', 'Affiliation': 'Crecon Research & Consulting Inc, Tokyo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Hokkaido University Hospital, Sapporo, Japan.'}]",Value in health regional issues,['10.1016/j.vhri.2021.06.012']
1479,34923618,Efficacy and safety of coronary computed tomography angiography in patients with a high clinical likelihood of obstructive coronary artery disease.,"BACKGROUND


The CAT-CAD trial showed that coronary computed tomography angiography (CTA) in patients with a high prevalence of coronary artery disease (CAD) and indications for invasive coronary angiography (ICA) reduces the number of patients undergoing ICA by two-thirds and nearly eradicates non-actionable ICAs. However, the long-term benefits of this non-invasive strategy remain unknown.
AIMS


To evaluate the long-term efficacy and safety of a non-invasive strategy employing coronary CTA vs. ICA as the first-line imaging test in stable patients with a high clinical likelihood of obstruc-tive CAD.
METHODS


The long-term outcomes were evaluated for 36 months following randomization and included the efficacy outcome (analyzed as the composite of major adverse cardiovascular events (MACE): all-cause death, acute coronary syndrome, unplanned coronary revascularization, urgent hospitalization for a cardiovascular reason, a stroke) and the safety outcome (analyzed as a cumulative incidence of serious adverse events).
RESULTS


One hundred and twenty participants at a mean age of 60.6 (7.9) years (female, 35.0%) were randomized with an allocation ratio of 1:1 to coronary CTA and direct ICA as the first-line anatomical test for suspected obstructive CAD. There were no significant differences between both diagnostic strategies neither in terms of the long-term efficacy (MACE occurrence: 15.5% in coronary CTA group vs. 16.7% in ICA group; log-rank P = 0.89) nor the long-term safety (cumulative number of serious adverse events: 36 vs. 38; P = 0.79, respectively).
CONCLUSIONS


Long-term follow-up of the randomized CAT-CAD trial confirms that the strategy employing coronary CTA is an effective and safe, non-invasive, outpatient-based alternative to ICA for patients with a high clinical likelihood of obstructive CAD.",2022,"There were no significant differences between both diagnostic strategies neither in terms of the long-term efficacy (MACE occurrence: 15.5% in coronary CTA group vs. 16.7% in ICA group; log-rank P = 0.89) nor the long-term safety (cumulative number of serious adverse events: respectively 36 vs. 38; P = 0.79).
","['patients with a high clinical likelihood of obstructive coronary artery disease', 'patients with a high clinical likelihood of obstructive CAD', 'stable patients with a high clinical likelihood of obstructive CAD', 'patients with a high prevalence of coronary artery disease (CAD) and indications for invasive coronary angiography (ICA', '120 participants with a mean age of 60.6 (7.9) years (female, 35.0']","['coronary computed tomography angiography', 'coronary computed tomography angiography (CTA', 'non-invasive strategy employing coronary CTA vs. ICA']","['Efficacy and safety', 'long-term efficacy (MACE occurrence', 'composite of major adverse cardiovascular events (MACE): all-cause death, acute coronary syndrome, unplanned coronary revascularization, urgent hospitalization for cardiovascular reason, stroke, and the safety outcome, analyzed as a cumulative incidence of serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.079702,"There were no significant differences between both diagnostic strategies neither in terms of the long-term efficacy (MACE occurrence: 15.5% in coronary CTA group vs. 16.7% in ICA group; log-rank P = 0.89) nor the long-term safety (cumulative number of serious adverse events: respectively 36 vs. 38; P = 0.79).
","[{'ForeName': 'Piotr Nikodem', 'Initials': 'PN', 'LastName': 'Rudziński', 'Affiliation': 'National Institute of Cardiology, Warszawa, Poland. piotr.rudzinski@ikard.pl.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Kruk', 'Affiliation': 'National Institute of Cardiology, Warszawa, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Demkow', 'Affiliation': 'National Institute of Cardiology, Warszawa, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Oleksiak', 'Affiliation': 'National Institute of Cardiology, Warszawa, Poland.'}, {'ForeName': 'Joseph U', 'Initials': 'JU', 'LastName': 'Schoepf', 'Affiliation': 'Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Mach', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Vienna General Hospital, Vienna, Austria.'}, {'ForeName': 'Zofia', 'Initials': 'Z', 'LastName': 'Dzielińska', 'Affiliation': 'National Institute of Cardiology, Warszawa, Poland.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Pręgowski', 'Affiliation': 'National Institute of Cardiology, Warszawa, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Witkowski', 'Affiliation': 'National Institute of Cardiology, Warszawa, Poland.'}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Rużyłło', 'Affiliation': 'National Institute of Cardiology, Warszawa, Poland.'}, {'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Kępka', 'Affiliation': 'National Institute of Cardiology, Warszawa, Poland.'}]",Kardiologia polska,['10.33963/KP.a2021.0185']
1480,34928698,Responses to a Neutralizing Monoclonal Antibody for Hospitalized Patients With COVID-19 According to Baseline Antibody and Antigen Levels : A Randomized Controlled Trial.,"BACKGROUND


In a randomized, placebo-controlled, clinical trial, bamlanivimab, a SARS-CoV-2-neutralizing monoclonal antibody, given in combination with remdesivir, did not improve outcomes among hospitalized patients with COVID-19 based on an early futility assessment.
OBJECTIVE


To evaluate the a priori hypothesis that bamlanivimab has greater benefit in patients without detectable levels of endogenous neutralizing antibody (nAb) at study entry than in those with antibodies, especially if viral levels are high.
DESIGN


Randomized, placebo-controlled trial. (ClinicalTrials.gov: NCT04501978).
SETTING


Multicenter trial.
PATIENTS


Hospitalized patients with COVID-19 without end-organ failure.
INTERVENTION


Bamlanivimab (7000 mg) or placebo.
MEASUREMENTS


Antibody, antigen, and viral RNA levels were centrally measured on stored specimens collected at baseline. Patients were followed for 90 days for sustained recovery (defined as discharge to home and remaining home for 14 consecutive days) and a composite safety outcome (death, serious adverse events, organ failure, or serious infections).
RESULTS


Among 314 participants (163 receiving bamlanivimab and 151 placebo), the median time to sustained recovery was 19 days and did not differ between the bamlanivimab and placebo groups (subhazard ratio [sHR], 0.99 [95% CI, 0.79 to 1.22]; sHR > 1 favors bamlanivimab). At entry, 50% evidenced production of anti-spike nAbs; 50% had SARS-CoV-2 nucleocapsid plasma antigen levels of at least 1000 ng/L. Among those without and with nAbs at study entry, the sHRs were 1.24 (CI, 0.90 to 1.70) and 0.74 (CI, 0.54 to 1.00), respectively (nominal  P  for interaction = 0.018). The sHR (bamlanivimab vs. placebo) was also more than 1 for those with plasma antigen or nasal viral RNA levels above median level at entry and was greatest for those without antibodies and with elevated levels of antigen (sHR, 1.48 [CI, 0.99 to 2.23]) or viral RNA (sHR, 1.89 [CI, 1.23 to 2.91]). Hazard ratios for the composite safety outcome (<1 favors bamlanivimab) also differed by serostatus at entry: 0.67 (CI, 0.37 to 1.20) for those without and 1.79 (CI, 0.92 to 3.48) for those with nAbs.
LIMITATION


Subgroup analysis of a trial prematurely stopped because of futility; small sample size; multiple subgroups analyzed.
CONCLUSION


Efficacy and safety of bamlanivimab may differ depending on whether an endogenous nAb response has been mounted. The limited sample size of the study does not allow firm conclusions based on these findings, and further independent trials are required that assess other types of passive immune therapies in the same patient setting.
PRIMARY FUNDING SOURCE


U.S. government Operation Warp Speed and National Institute of Allergy and Infectious Diseases.",2022,"The sHR (bamlanivimab vs. placebo) was also more than 1 for those with plasma antigen or nasal viral RNA levels above median level at entry and was greatest for those without antibodies and with elevated levels of antigen (sHR, 1.48 [CI, 0.99 to 2.23]) or viral RNA (sHR, 1.89 [CI, 1.23 to 2.91]).","['Hospitalized Patients With COVID-19', '314 participants (163 receiving', 'Hospitalized patients with COVID-19 without end-organ failure', 'hospitalized patients with COVID-19 based on an early futility assessment']","['placebo', 'bamlanivimab and 151 placebo', 'bamlanivimab', 'Bamlanivimab (7000 mg) or placebo', 'sHR (bamlanivimab vs. placebo']","['median time to sustained recovery', 'Antibody, antigen, and viral RNA levels', 'composite safety outcome (death, serious adverse events, organ failure, or serious infections', 'plasma antigen or nasal viral RNA levels']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0086322', 'cui_str': 'Futility'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C1439030', 'cui_str': 'SHORT ROOT protein, Arabidopsis'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0035736', 'cui_str': 'Viral RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]",,0.699419,"The sHR (bamlanivimab vs. placebo) was also more than 1 for those with plasma antigen or nasal viral RNA levels above median level at entry and was greatest for those without antibodies and with elevated levels of antigen (sHR, 1.48 [CI, 0.99 to 2.23]) or viral RNA (sHR, 1.89 [CI, 1.23 to 2.91]).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Jens D', 'Initials': 'JD', 'LastName': 'Lundgren', 'Affiliation': 'CHIP Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Grund', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Christina E', 'Initials': 'CE', 'LastName': 'Barkauskas', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Holland', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': 'Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Uriel', 'Initials': 'U', 'LastName': 'Sandkovsky', 'Affiliation': 'Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Brown', 'Affiliation': 'Intermountain Medical Center, Murray, and University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Kirk U', 'Initials': 'KU', 'LastName': 'Knowlton', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, Utah.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'D Clark', 'Initials': 'DC', 'LastName': 'Files', 'Affiliation': 'Section on Pulmonary, Critical Care, Allergy, and Immunology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Mamta K', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Department of Infectious Diseases, Hvidovre and Amager Hospital, University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Bowdish', 'Affiliation': 'Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Bradley G', 'Initials': 'BG', 'LastName': 'Leshnower', 'Affiliation': 'Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Jason V', 'Initials': 'JV', 'LastName': 'Baker', 'Affiliation': 'Hennepin Healthcare Research Institute and University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Jens-Ulrik', 'Initials': 'JU', 'LastName': 'Jensen', 'Affiliation': 'CHIP Centre of Excellence for Health, Immunity and Infections, Rigshospitalet, Copenhagen, and Respiratory Medicine Section, Department of Internal Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Gardner', 'Affiliation': 'Denver Public Health, Denver Health and Hospital Authority, Denver, Colorado.'}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, University of Colorado, Aurora, Colorado.'}, {'ForeName': 'Estelle S', 'Initials': 'ES', 'LastName': 'Harris', 'Affiliation': 'University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Isik S', 'Initials': 'IS', 'LastName': 'Johansen', 'Affiliation': 'Department of Infectious Diseases, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Markowitz', 'Affiliation': 'Department of Infectious Diseases, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Matthay', 'Affiliation': 'Department of Medicine and Department of Anesthesia and Cardiovascular Research Institute, The University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Aarhus University Hospital Skejby, Aarhus, Denmark.'}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Goodman', 'Affiliation': ""Medical Research Council Clinical Trials Unit at University College London and Guy's & St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Weizhong', 'Initials': 'W', 'LastName': 'Chang', 'Affiliation': 'Laboratory of Human Retrovirology and Immunoinformatics, Frederick National Laboratory for Cancer Research, Frederick, Maryland.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Dewar', 'Affiliation': 'Leidos Biomedical Research, Frederick, Maryland.'}, {'ForeName': 'Norman P', 'Initials': 'NP', 'LastName': 'Gerry', 'Affiliation': 'Advanced Biomedical Laboratories, Cinnaminson, New Jersey.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Higgs', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Highbarger', 'Affiliation': 'Leidos Biomedical Research and AIDS Monitoring Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Murray', 'Affiliation': 'CHIP Centre of Excellence for Health, Immunity and Infections, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Murray', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Ven', 'Initials': 'V', 'LastName': 'Natarajan', 'Affiliation': 'Laboratory of Molecular Cell Biology, Frederick National Laboratory for Cancer Research, Frederick, Maryland.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Paredes', 'Affiliation': 'Infectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Mahesh K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'Medical Research Council Clinical Trials Unit and Institute of Clinical Trials and Methodology at University College London, London, United Kingdom.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Phillips', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': 'Cavan', 'Initials': 'C', 'LastName': 'Reilly', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Rupert', 'Affiliation': 'AIDS Monitoring Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Shaw-Saliba', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.'}, {'ForeName': 'Brad T', 'Initials': 'BT', 'LastName': 'Sherman', 'Affiliation': 'Laboratory of Human Retrovirology and Immunoinformatics, Frederick National Laboratory for Cancer Research, Frederick, Maryland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Teitelbaum', 'Affiliation': 'Leidos Biomedical Research, Frederick, Maryland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Wentworth', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Huyen', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Abdel G', 'Initials': 'AG', 'LastName': 'Babiker', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, London, United Kingdom.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Davey', 'Affiliation': 'U.S. Department of Veterans Affairs, Washington, DC.'}, {'ForeName': 'Annetine C', 'Initials': 'AC', 'LastName': 'Gelijns', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Virginia L', 'Initials': 'VL', 'LastName': 'Kan', 'Affiliation': 'Veterans Affairs Medical Center and School of Medicine and Health Sciences, George Washington University, Washington, DC.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Polizzotto', 'Affiliation': ""The Kirby Institute, University of New South Wales, and St Vincent's Hospital, Sydney, New South Wales, Australia.""}, {'ForeName': 'B Taylor', 'Initials': 'BT', 'LastName': 'Thompson', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota.'}]",Annals of internal medicine,['10.7326/M21-3507']
1481,34930750,ParkinSong Online: protocol for a telehealth feasibility study of therapeutic group singing for people with Parkinson's disease.,"INTRODUCTION


Parkinson's disease can be associated with speech deterioration and low communication confidence which in turn compromises social interaction. Therapeutic singing is an engaging method for combatting speech decline; however, face-to-face delivery can limit access to group singing. The aim of this study is to test the feasibility and acceptability of an online mode of delivery for a Parkinson's singing intervention (ParkinSong) as well as remote data collection procedures.
METHODS AND ANALYSIS


This ParkinSong Online feasibility trial is a single-arm, pre-post study of online singing delivery and remote data collection for 30 people living with Parkinson's. The primary outcome measure is feasibility: recruitment, retention, attendance, safety, intervention fidelity, acceptability and associated costs. Secondary outcomes are speech (loudness, intelligibility, quality, communication-related quality of life) and wellbeing (apathy, depression, anxiety, stress, health-related quality of life). This mode of delivery aims to increase the accessibility of singing interventions.
ETHICS AND DISSEMINATION


Ethics approval was obtained from The University of Melbourne Human Research Ethics Committee (2021-14465-16053-3) and the trial has been prospectively registered. Results will be presented at national and international conferences, published in a peer-reviewed journal, and disseminated to the Parkinson's community, researchers and policymakers.
TRIAL REGISTRATION NUMBER


ACTRN12621000940875.",2021,"The aim of this study is to test the feasibility and acceptability of an online mode of delivery for a Parkinson's singing intervention (ParkinSong) as well as remote data collection procedures.
","[""30 people living with Parkinson's"", ""people with Parkinson's disease""]","[""Parkinson's singing intervention (ParkinSong"", 'therapeutic group singing', 'online singing delivery and remote data collection']","['speech (loudness, intelligibility, quality, communication-related quality of life) and wellbeing (apathy, depression, anxiety, stress, health-related quality of life', 'feasibility: recruitment, retention, attendance, safety, intervention fidelity, acceptability and associated costs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0589416', 'cui_str': 'Intelligibility'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.113547,"The aim of this study is to test the feasibility and acceptability of an online mode of delivery for a Parkinson's singing intervention (ParkinSong) as well as remote data collection procedures.
","[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Tamplin', 'Affiliation': 'Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia jeanette.tamplin@unimelb.edu.au.'}, {'ForeName': 'Meg E', 'Initials': 'ME', 'LastName': 'Morris', 'Affiliation': 'Academic and Research Collaborative in Health, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Felicity A', 'Initials': 'FA', 'LastName': 'Baker', 'Affiliation': 'Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tanara Vieira', 'Initials': 'TV', 'LastName': 'Sousa', 'Affiliation': 'Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Haines', 'Affiliation': 'Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Dunn', 'Affiliation': 'Consumer Representative, Melbourne, Victoria, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Tull', 'Affiliation': ""Fight Parkinson's (Formerly Parkinson's Victoria), Surrey Hills, Victoria, Australia.""}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Vogel', 'Affiliation': 'Centre for Neuroscience of Speech, The University of Melbourne, Melbourne, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2021-058953']
1482,34936057,Pirfenidone in Unclassifiable Interstitial Lung Disease: A Subgroup Analysis by Concomitant Mycophenolate Mofetil and/or Previous Corticosteroid Use.,"INTRODUCTION


There are currently no approved treatments solely for unclassifiable interstitial lung disease (uILD); however, a recent trial showed this population can benefit from pirfenidone. We report a subgroup analysis of this trial to assess the effects of immunomodulators (concomitant mycophenolate mofetil [MMF] and/or previous corticosteroids) with pirfenidone in patients with uILD.
METHODS


This was a multicenter, international, double-blind, randomized, placebo-controlled phase II trial of patients with progressive fibrosing uILD (NCT03099187). Patients were randomized (1:1) to receive pirfenidone 2403 mg/day or placebo. This analysis assessed forced vital capacity (FVC) change from baseline measured using site spirometry (key secondary endpoint) and safety over 24 weeks by concomitant MMF use at randomization (pre-specified analysis) and/or previous corticosteroid use (post hoc analysis).
RESULTS


Overall, 253 patients were randomized, including 45 (17.8%) patients (pirfenidone, n = 23; placebo, n = 22) receiving concomitant MMF with/without previous corticosteroids (MMF subgroup); 79 (31.2%) patients (pirfenidone, n = 44; placebo, n = 35) receiving previous corticosteroids without MMF (corticosteroids/no-MMF subgroup); and 129 (51.0%) patients (pirfenidone, n = 60; placebo, n = 69) not receiving concomitant MMF or previous corticosteroids (no-corticosteroids/no-MMF subgroup). At 24 weeks, difference in mean (95% confidence interval) FVC change from baseline between pirfenidone and placebo was - 55.4 mL (- 206.7, 96.0; P = 0.4645) in the MMF subgroup; 128.4 mL (- 6.4, 263.3; P = 0.0617) in the corticosteroids/no-MMF subgroup; and 115.5 mL (35.1, 195.9; P = 0.0052) in the no-corticosteroids/no-MMF subgroup. All subgroups generally exhibited a similar pattern of treatment-emergent adverse events.
CONCLUSION


Although limited by design and small sample sizes, this analysis suggests pirfenidone may be less effective in patients with uILD receiving concomitant MMF, whereas a beneficial treatment effect was observed in patients not receiving concomitant MMF regardless of previous corticosteroid use. Pirfenidone was well tolerated regardless of MMF and/or corticosteroid use.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov: NCT03099187.",2022,"All subgroups generally exhibited a similar pattern of treatment-emergent adverse events.
","['253 patients were randomized, including 45 (17.8%) patients (pirfenidone, n\u2009=\u200923', 'patients with progressive fibrosing uILD (NCT03099187', 'Unclassifiable Interstitial Lung Disease', 'patients with uILD receiving concomitant MMF', 'patients with uILD']","['placebo', 'Mycophenolate Mofetil', 'Pirfenidone', 'placebo, n\u2009=\u200922) receiving concomitant MMF with/without previous corticosteroids (MMF subgroup); 79 (31.2%) patients (pirfenidone, n\u2009=\u200944; placebo, n\u2009=\u200935) receiving previous corticosteroids without MMF (corticosteroids/no-MMF subgroup', 'pirfenidone, n\u2009=\u200960; placebo, n\u2009=\u200969) not receiving concomitant MMF or previous corticosteroids (no-corticosteroids/no-MMF subgroup', 'pirfenidone 2403\xa0mg/day or placebo', 'mL', 'immunomodulators (concomitant mycophenolate mofetil [MMF', 'pirfenidone']",['forced vital capacity (FVC) change'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C5191319', 'cui_str': '31.2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0001551', 'cui_str': 'Immunologic adjuvant'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",253.0,0.447244,"All subgroups generally exhibited a similar pattern of treatment-emergent adverse events.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Department of Pulmonology and Critical Care Medicine, Center for Interstitial and Rare Lung Diseases, Thoraxklinik, University of Heidelberg, Roentgen Street 1, 69126, Heidelberg, Germany. kreuter@uni-heidelberg.de.'}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'Interstitial Lung Disease Unit, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Tamera J', 'Initials': 'TJ', 'LastName': 'Corte', 'Affiliation': 'Department of Respiratory Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Molina-Molina', 'Affiliation': ""ILD Unit, Respiratory Department, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), University Hospital of Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Axmann', 'Affiliation': 'F. Hoffmann-La Roche, Ltd., Basel, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Gilberg', 'Affiliation': 'F. Hoffmann-La Roche, Ltd., Basel, Switzerland.'}, {'ForeName': 'Klaus-Uwe', 'Initials': 'KU', 'LastName': 'Kirchgaessler', 'Affiliation': 'F. Hoffmann-La Roche, Ltd., Basel, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'National Reference Coordinating Center for Rare Pulmonary Diseases (OrphaLung), Louis Pradel Hospital, Hospices Civils de Lyon, Lyon, France.'}]",Advances in therapy,['10.1007/s12325-021-02009-w']
1483,34933753,Antiadenovirus Antibodies Predict Response Durability to Nadofaragene Firadenovec Therapy in BCG-unresponsive Non-muscle-invasive Bladder Cancer: Secondary Analysis of a Phase 3 Clinical Trial.,"A recent phase 3 trial of intravesical nadofaragene firadenovec reported a promising complete response rate for patients with bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer. This study examined the ability of antiadenovirus antibody levels to predict the durability of therapeutic response to nadofaragene firadenovec. A standardized and validated quantitative assay was used to prospectively assess baseline and post-treatment serum antibody levels among 91 patients from the phase 3 trial, of whom 47 (52%) were high-grade recurrence free at 12 mo (responders). While baseline titers did not predict treatment response, 3-mo titer >800 was associated with a higher likelihood of durable response (p = 0.026). Peak post-treatment titers >800 were noted in 42 (89%) responders versus 26 (59%) nonresponders (p = 0.001; assay sensitivity, 89%; negative predictive value, 78%). Moreover, 22 (47%) responders compared with eight (18%) nonresponders had a combination of peak post-treatment titers >800 and peak antibody fold change >8 (p = 0.004; assay specificity, 82%; positive predictive value, 73%). A majority of responders continued to have post-treatment antibody titers >800 after the first 6 mo of therapy. In conclusion, serum antiadenovirus antibody quantification may serve as a novel predictive marker for nadofaragene firadenovec response durability. Future studies will focus on large-scale validation and clinical utility of the assay. PATIENT SUMMARY: This study reports on a planned secondary analysis of a phase 3 multicenter clinical trial that established the benefit of nadofaragene firadenovec, a novel intravesical gene therapeutic, for the treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer. Prospective assessment of serum anti-human adenovirus type-5 antibody levels of patients in this trial indicated that a combination of post-treatment titers and fold change from baseline can predict treatment efficacy. While this merits additional validation, our findings suggest that serum antiadenovirus antibody levels can serve as an important predictive marker for the durability of therapeutic response to nadofaragene firadenovec.",2022,"nonresponders (p = 0.001; assay sensitivity, 89%; negative predictive value, 78%).","['BCG-unresponsive Non-muscle-invasive Bladder Cancer', 'patients with bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer', 'patients with bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer', '91 patients from the phase 3 trial, of whom 47 (52%) were high-grade recurrence free at 12 mo (responders']",['Nadofaragene Firadenovec Therapy'],['durable response'],"[{'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0660188,"nonresponders (p = 0.001; assay sensitivity, 89%; negative predictive value, 78%).","[{'ForeName': 'Anirban P', 'Initials': 'AP', 'LastName': 'Mitra', 'Affiliation': 'Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Vikram M', 'Initials': 'VM', 'LastName': 'Narayan', 'Affiliation': 'Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sharada', 'Initials': 'S', 'LastName': 'Mokkapati', 'Affiliation': 'Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Tanner', 'Initials': 'T', 'LastName': 'Miest', 'Affiliation': 'Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Boorjian', 'Affiliation': 'Department of Urology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Alemozaffar', 'Affiliation': 'Department of Urology, Kaiser Permanente Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Badrinath R', 'Initials': 'BR', 'LastName': 'Konety', 'Affiliation': 'Department of Urology, Rush Medical College, Chicago, IL, USA.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': 'Carolina Urologic Research Center, Myrtle Beach, SC, USA.'}, {'ForeName': 'Leonard G', 'Initials': 'LG', 'LastName': 'Gomella', 'Affiliation': 'Department of Urology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Ashish M', 'Initials': 'AM', 'LastName': 'Kamat', 'Affiliation': 'Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Trinity J', 'Initials': 'TJ', 'LastName': 'Bivalacqua', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Montgomery', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Seth P', 'Initials': 'SP', 'LastName': 'Lerner', 'Affiliation': 'Scott Department of Urology, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'J Erik', 'Initials': 'JE', 'LastName': 'Busby', 'Affiliation': 'Department of Surgery, Prisma Health, University of South Carolina School of Medicine at Greenville, Greenville, SC, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Poch', 'Affiliation': 'Department of Genitourinary Oncology, H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Crispen', 'Affiliation': 'Department of Urology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Steinberg', 'Affiliation': 'Department of Urology, New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Schuckman', 'Affiliation': 'Institute of Urology, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Tracy M', 'Initials': 'TM', 'LastName': 'Downs', 'Affiliation': 'Department of Urology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Svatek', 'Affiliation': 'Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Mashni', 'Affiliation': 'Department of Surgical Oncology, Banner MD Anderson Cancer Center, Gilbert, AZ, USA.'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Lane', 'Affiliation': 'Division of Urology, Spectrum Health, Michigan State University College of Human Medicine, Grand Rapids, MI, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Guzzo', 'Affiliation': 'Division of Urology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gennady', 'Initials': 'G', 'LastName': 'Bratslavsky', 'Affiliation': 'Department of Urology, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Lawrence I', 'Initials': 'LI', 'LastName': 'Karsh', 'Affiliation': 'The Urology Center of Colorado, Denver, CO, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Woods', 'Affiliation': 'Department of Urology, Loyola University, Maywood, IL, USA.'}, {'ForeName': 'Gordon A', 'Initials': 'GA', 'LastName': 'Brown', 'Affiliation': 'New Jersey Urology, Bloomfield, NJ, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Canter', 'Affiliation': 'Georgia Urology, Atlanta, GA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Luchey', 'Affiliation': 'Department of Urology, West Virginia University Cancer Institute, Morgantown, WV, USA.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Lotan', 'Affiliation': 'Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Krupski', 'Affiliation': 'Department of Urology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Brant A', 'Initials': 'BA', 'LastName': 'Inman', 'Affiliation': 'Division of Urology, Department of Surgery, Duke University, Durham, NC, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Williams', 'Affiliation': 'Urology of Virginia, Virginia Beach, VA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Cookson', 'Affiliation': 'Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Kirk A', 'Initials': 'KA', 'LastName': 'Keegan', 'Affiliation': 'Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'Andriole', 'Affiliation': 'Division of Urologic Surgery, Department of Surgery, Washington University School of Medicine in St Louis, St Louis, MO, USA.'}, {'ForeName': 'Alexander I', 'Initials': 'AI', 'LastName': 'Sankin', 'Affiliation': 'Department of Urology, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Boyd', 'Affiliation': 'Boyd Consultants Ltd, Crewe, UK.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Urology, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Philipson', 'Affiliation': 'Trizell Ltd, Chinnor, UK.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Ylä-Herttuala', 'Affiliation': 'AI Virtanen Institute for Molecular Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sawutz', 'Affiliation': 'FKD Therapies Oy, Kuopio, Finland.'}, {'ForeName': 'Nigel R', 'Initials': 'NR', 'LastName': 'Parker', 'Affiliation': 'AI Virtanen Institute for Molecular Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'McConkey', 'Affiliation': 'Department of Urology, Greenberg Bladder Cancer Institute, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Colin P N', 'Initials': 'CPN', 'LastName': 'Dinney', 'Affiliation': 'Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: cdinney@mdanderson.org.'}]",European urology,['10.1016/j.eururo.2021.12.009']
1484,34861376,Outcome without any adjuvant systemic treatment in stage I ER+/HER2- breast cancer patients included in the MINDACT trial.,"BACKGROUND


Adjuvant systemic treatments (AST) reduce mortality, but have associated short- and long-term toxicities. Careful selection of patients likely to benefit from AST is needed. We evaluated outcome of low-risk breast cancer patients of the EORTC 10041/BIG 3-04 MINDACT trial who received no AST.
PATIENTS AND METHODS


Patients with estrogen receptor-positive, HER2-negative, lymph node-negative tumors ≤2 cm who received no AST were matched 1 : 1 to patients with similar tumor characteristics treated with adjuvant endocrine therapy (ET), using propensity score matching and exact matching on age, genomic risk (70-gene signature) and grade. In a post hoc analysis, distant metastasis-free interval (DMFI) and overall survival (OS) were assessed by Kaplan-Meier analysis and hazard ratios (HR) by Cox regression. Cumulative incidences of locoregional recurrence (LRR) and contralateral breast cancer (CBC) were assessed with competing risk analyses.
RESULTS


At 8 years, DMFI rates were 94.8% [95% confidence interval (CI) 92.7% to 96.9%] in 509 patients receiving no AST, and 97.3% (95% CI 95.8% to 98.8%) in 509 matched patients who received only ET [absolute difference: 2.5%, HR 0.56 (95% CI 0.30-1.03)]. No statistically significant difference was seen in 8-year OS rates, 95.4% (95% CI 93.5% to 97.4%) in patients receiving no AST and 95.6% (95% CI 93.8% to 97.5%) in patients receiving only ET [absolute difference: 0.2%, HR 0.86 (95% CI 0.53-1.41)]. Cumulative incidence rates of LRR and CBC were 4.7% (95% CI 3.0% to 7.0%) and 4.6% (95% CI 2.9% to 6.9%) in patients receiving no AST versus 1.4% (95% CI 0.6% to 2.9%) and 1.5% (95% CI 0.6% to 3.1%) in patients receiving only ET.
CONCLUSIONS


In patients with stage I low-risk breast cancer, the effect of ET on DMFI was limited, but overall significantly fewer breast cancer events were observed in patients who received ET, after the relatively short follow-up of 8 years. These benefits and side-effects of ET should be discussed with all patients, even those at a very low risk of distant metastasis.",2022,"At 8 years, DMFI rates were 94.8% [95% confidence interval (CI) 92.7% to 96.9%] in 509 patients receiving no AST, and 97.3% (95% CI 95.8% to 98.8%) in 509 matched patients who received only ET [absolute difference: 2.5%, HR 0.56 (95% CI 0.30-1.03)].","['low-risk breast cancer patients of the EORTC', 'Patients with estrogen receptor-positive, HER2-negative, lymph node-negative tumors ≤2 cm who received no AST were matched 1 : 1 to patients with similar tumor characteristics treated with', 'patients with stage I low-risk breast cancer', 'stage I ER+/HER2- breast cancer patients included in the MINDACT trial']","['no AST', 'adjuvant endocrine therapy (ET']","['Cumulative incidence rates of LRR and CBC', 'breast cancer events', 'Cumulative incidences of locoregional recurrence (LRR) and contralateral breast cancer (CBC', 'distant metastasis-free interval (DMFI) and overall survival (OS', '8-year OS rates', 'DMFI rates']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1096616', 'cui_str': 'Contralateral breast cancer'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",509.0,0.45423,"At 8 years, DMFI rates were 94.8% [95% confidence interval (CI) 92.7% to 96.9%] in 509 patients receiving no AST, and 97.3% (95% CI 95.8% to 98.8%) in 509 matched patients who received only ET [absolute difference: 2.5%, HR 0.56 (95% CI 0.30-1.03)].","[{'ForeName': 'J M N', 'Initials': 'JMN', 'LastName': 'Lopes Cardozo', 'Affiliation': 'Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands; European Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Byng', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Drukker', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Schmidt', 'Affiliation': 'Division of Molecular Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Binuya', 'Affiliation': 'Division of Molecular Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands; Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': ""van 't Veer"", 'Affiliation': 'Department of Laboratory Medicine, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': 'Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Smorenburg', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Poncet', 'Affiliation': 'European Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.'}, {'ForeName': 'E J T', 'Initials': 'EJT', 'LastName': 'Rutgers', 'Affiliation': 'Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: e.rutgers@nki.nl.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.11.014']
1485,34953520,"Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial.","BACKGROUND


We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19.
METHODS


In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978.
FINDINGS


Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50-72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74-1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67-1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74-1·58]; BRII-196 plus BRII-198 1·00 [0·68-1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91-1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88-1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90.
INTERPRETATION


Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.
FUNDING


US National Institutes of Health and Operation Warp Speed.",2021,"The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation.","['Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days', 'adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised', 'Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited', 'Between Dec 16, 2020, and March 1, 2021, 546 patients', 'n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50-72], 228 [43%] patients were female and 308 [57%] were male', 'adults hospitalised with COVID-19', 'adults hospitalised with COVID-19 (TICO']","['placebo', 'sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo', 'sotrovimab', 'neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198', 'neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences']","['Efficacy and safety', 'Efficacy and safety outcomes', 'pulmonary-plus complications scale', 'sustained clinical recovery', 'efficacy and safety', 'pulmonary status and extrapulmonary complications of COVID-19', 'composite safety outcome', 'time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home', 'pulmonary scale', 'composite of death, serious adverse events, incident organ failure, and serious coinfection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0042752', 'cui_str': 'US Virgin island'}, {'cui': 'C0005574', 'cui_str': 'Biotechnology'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}]",546.0,0.575955,"The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(21)00751-9']
1486,34952881,Melatonin for prevention of postoperative delirium after lower limb fracture surgery in elderly patients (DELIRLESS): study protocol for a multicentre randomised controlled trial.,"INTRODUCTION


Postoperative delirium (POD) is one of the most frequent complication after surgery in elderly patients, and is associated with increased morbidity and mortality, prolonged length of stay, cognitive and functional decline leading to loss of autonomy, and important additional healthcare costs. Perioperative inflammatory stress is a key element in POD genesis. Melatonin exhibits antioxidative and immune-modulatory proprieties that are promising concerning delirium prevention, but in perioperative context literature are scarce and conflicting. We hypothesise that perioperative melatonin can reduce the incidence of POD.
METHODS AND ANALYSIS


The DELIRLESS trial is a prospective, national multicentric, phase III, superiority, comparative randomised (1:1) double-blind clinical trial. Among patients aged 70 or older, hospitalised and scheduled for surgery of a severe fracture of a lower limb, 718 will be randomly allocated to receive either melatonin 4 mg per os or placebo, every night from anaesthesiologist preoperative consultation and up to 5 days after surgery. The primary outcome is POD incidence measured by either the French validated translation of the Confusion Assessment Method (CAM) score for patients hospitalised in surgery, or CAM-ICU score for patients hospitalised in ICU (Intensive Care Unit). Daily delirium assessment will take place during 10 days after surgery, or until the end of hospital stay if it is shorter. POD cumulative incidence function will be compared at day 10 between the two randomised arms in a competing risks framework, using the Fine and Grey model with death as a competing risk of delirium.
ETHICS AND DISSEMINATION


The DELIRLESS trial has been approved by an independent ethics committee the Comité de Protection des Personnes (CPP) Sud-Est (ref CPP2020-18-99 2019-003210-14) for all study centres. Participant recruitment begins in December 2020. Results will be published in international peer-reviewed medical journals.
TRIAL REGISTRATION NUMBER


NCT04335968, first posted 7 April 2020.
PROTOCOL VERSION IDENTIFIER


N°3-0, 3 May 2021.",2021,The DELIRLESS trial has been approved by an independent ethics committee the Comité de Protection des Personnes (CPP),"['elderly patients', 'postoperative delirium after lower limb fracture surgery in elderly patients', 'patients aged 70 or older, hospitalised and scheduled for surgery of a severe fracture of a lower limb, 718']","['Melatonin', 'melatonin 4\u2009mg per os or placebo']","['POD cumulative incidence function', 'POD incidence measured by either the French validated translation of the Confusion Assessment Method (CAM) score for patients hospitalised in surgery, or CAM-ICU score']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C1542178', 'cui_str': 'Fracture of lower leg'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",,0.48887,The DELIRLESS trial has been approved by an independent ethics committee the Comité de Protection des Personnes (CPP),"[{'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Sigaut', 'Affiliation': 'Anesthesiology and Intensive Care, Hôpital Beaujon, Clichy, France stephanie.sigaut@aphp.fr.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Couffignal', 'Affiliation': 'Unité de recherche Clinique, Hôpital Bichat - Claude-Bernard, Paris, Île-de-France, France.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Esposito-Farèse', 'Affiliation': 'Unité de recherche Clinique, Hôpital Bichat - Claude-Bernard, Paris, Île-de-France, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Degos', 'Affiliation': 'Anesthesiology and Intensive Care, University Hospital Pitié Salpêtrière, Paris, Île-de-France, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Molliex', 'Affiliation': 'Anesthesie Reanimation, Centre Hospitalier Universitaire de Saint-Etienne, Saint-Etienne, Rhône-Alpes, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Boddaert', 'Affiliation': 'Faculty of Health, Sorbonne Universite, Paris, Île-de-France, France.'}, {'ForeName': 'Agathe', 'Initials': 'A', 'LastName': 'Raynaud-Simon', 'Affiliation': 'Geriatric Medicine, Hôpital Bichat - Claude-Bernard, Paris, Île-de-France, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': 'URC Eco, Hôpital Hôtel-Dieu de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Marcault', 'Affiliation': 'Unité de recherche Clinique, Hôpital Bichat - Claude-Bernard, Paris, Île-de-France, France.'}, {'ForeName': 'Madalina', 'Initials': 'M', 'LastName': 'Jacota', 'Affiliation': 'URC HUPIFO, Hopital Ambroise-Pare, Boulogne-Billancourt, Île-de-France, France.'}, {'ForeName': 'Souhayl', 'Initials': 'S', 'LastName': 'Dahmani', 'Affiliation': 'Faculty of Health, Université de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Paugam-Burtz', 'Affiliation': 'Faculty of Health, Université de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Weiss', 'Affiliation': 'Anesthesiology and Intensive Care, Hôpital Beaujon, Clichy, France.'}]",BMJ open,['10.1136/bmjopen-2021-053908']
1487,34879245,Postoperative sensitivity in posterior resin composite restorations with prior application of a glutaraldehyde-based desensitizing solution: A randomized clinical trial.,"OBJECTIVES


To evaluate the effect of a glutaraldehyde-based desensitizer on the postoperative sensitivity (POS) in posterior resin composite restorations up to 12 months using a universal adhesive (Tetric N-Bond Universal) with selective enamel etching (SE) or an etch-and-rinse (ER) strategy.
METHODS


Class I and class II resin composite restorations (n = 220) at least 3 mm deep were inserted in 55 subjects. The universal adhesive was applied using the SE (self-etch strategy on dentin with selective enamel etching) or the ER strategy, with or without prior application of a glutaraldehyde-based desensitizer (Gluma Desensitizer - GL) to form groups SEGL and ERGL. A bulk-fill resin composite (Tetric NCeram Bulk Fill) was used for all restorations. Spontaneous POS was assessed 7 days after the restorative procedure using the Visual Analog Scale (VAS) and the Numeric Rating Scale (NRS). After 7, 14, and 30 days of completing each restoration, the subjects were reassessed to evaluate POS caused by stimulation with an air blast, horizontal and vertical percussion. In addition, marginal discoloration, marginal adaptation, fracture, and recurrence of caries were evaluated using the FDI (World Dental Federation) criteria after 7 days and at 12 months.
RESULTS


No significant spontaneous or stimuli-induced POS was observed when restorations with or without GL were compared (p>0.05). A higher risk of spontaneous POS was observed within 7 days (40.0%; 95% CI 28.1 to 53.1), without statistically significant differences among groups. None of the participants reported POS at 12 months, however five restorations were considered clinically unsatisfactory (p > 0.05).
CONCLUSIONS


The previous application of GL did not significantly reduce spontaneous or stimuli-induced POS in posterior resin composite restorations at any time, regardless of the adhesive strategy used.
CLINICAL SIGNIFICANCE


The use of a glutaraldehyde-based desensitizing agent did not generate lower incidence of postoperative sensitivity in resin composite posterior restorations.",2022,The use of a glutaraldehyde-based desensitizing agent did not generate lower incidence of postoperative sensitivity in resin composite posterior restorations.,"['posterior resin composite restorations up to 12 months using a universal adhesive (Tetric N-Bond Universal) with', 'Class I and class II resin composite restorations (n\xa0', 'resin composite posterior restorations']","['selective enamel etching (SE) or an etch-and-rinse (ER) strategy', 'glutaraldehyde-based desensitizing agent', 'glutaraldehyde-based desensitizer (Gluma Desensitizer - GL', 'glutaraldehyde-based desensitizing solution', 'glutaraldehyde-based desensitizer']","['Visual Analog Scale (VAS) and the Numeric Rating Scale (NRS', 'spontaneous POS', 'marginal discoloration, marginal adaptation, fracture, and recurrence of caries', 'Spontaneous POS', 'Postoperative sensitivity', 'postoperative sensitivity (POS', 'spontaneous or stimuli-induced POS', 'postoperative sensitivity']","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0292041', 'cui_str': 'Tetric'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0017814', 'cui_str': 'Glutaral'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0673224', 'cui_str': 'gluma desensitizer'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",5.0,0.0478779,The use of a glutaraldehyde-based desensitizing agent did not generate lower incidence of postoperative sensitivity in resin composite posterior restorations.,"[{'ForeName': 'Isabelle Lins Macêdo', 'Initials': 'ILM', 'LastName': 'de Oliveira', 'Affiliation': 'Dental School, Universidade de Pernambuco, Pernambuco, PE, Brazil; Instituto de Tecnologia de Pernambuco - ITEP/ Block B 1st floor. Av. Prof. Luis Freire, 700 - Cidade Universitária, Recife-PE, Brazil 50740-540.'}, {'ForeName': 'Taíse Alessandra', 'Initials': 'TA', 'LastName': 'Hanzen', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Campus Uvaranas - Bloco M - 52B 2° Piso, General Carlos Cavalcanti Avenue, 4748 - Ponta Grossa - PR, 84030-900, Brazil.'}, {'ForeName': 'Alexandra Mara', 'Initials': 'AM', 'LastName': 'de Paula', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Campus Uvaranas - Bloco M - 52B 2° Piso, General Carlos Cavalcanti Avenue, 4748 - Ponta Grossa - PR, 84030-900, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Perdigão', 'Affiliation': 'Universidade Católica Portuguesa, Centre for Interdisciplinary Research in Health, Faculty of\xa0Dental Medicine, Estrada da Circunvalação, 3504-505 Viseu, Portugal; Department of Restorative Sciences, School of Dentistry, University of Minnesota, 515 Delaware St. SE, 8-450 Moos Tower, Minneapolis, MN, 55455, United States. Electronic address: jperdigao@ucp.pt.'}, {'ForeName': 'Marcos Antonio Japiassú Resende', 'Initials': 'MAJR', 'LastName': 'Montes', 'Affiliation': 'Dental School, Universidade de Pernambuco, Pernambuco, PE, Brazil; Instituto de Tecnologia de Pernambuco - ITEP/ Block B 1st floor. Av. Prof. Luis Freire, 700 - Cidade Universitária, Recife-PE, Brazil 50740-540.'}, {'ForeName': 'Alessandro Dourado', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Campus Uvaranas - Bloco M - 52B 2° Piso, General Carlos Cavalcanti Avenue, 4748 - Ponta Grossa - PR, 84030-900, Brazil.'}, {'ForeName': 'Gabriela Queiroz de Melo', 'Initials': 'GQM', 'LastName': 'Monteiro', 'Affiliation': 'Dental School, Universidade de Pernambuco, Pernambuco, PE, Brazil; Instituto de Tecnologia de Pernambuco - ITEP/ Block B 1st floor. Av. Prof. Luis Freire, 700 - Cidade Universitária, Recife-PE, Brazil 50740-540.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103918']
1488,34953926,Ketamine vs midazolam: Mood improvement reduces suicidal ideation in depression.,"OBJECTIVE


Studies demonstrate rapid antidepressant and anti-suicidal ideation effects of subanesthetic ketamine. The specific subcomponents of depression that are most closely tied to reduction of suicidal ideation with ketamine treatment are less explored.
METHODS


Exploratory, post hoc analysis of data from a randomized clinical trial of ketamine vs midazolam in patients with major depressive disorder (MDD) and clinically significant suicidal ideation examined changes in factor analysis-derived symptom clusters from standard measures of depression (Hamilton Depression Rating Scale, HDRS; Beck Depression Inventory, BDI) and mood disturbance (Profile of Mood States, POMS), and their relationship to severity of suicidal ideation (Beck Scale for Suicidal Ideation; SSI). Ratings obtained before and one day after blinded intravenous infusion were decomposed into component factors or published subscales. Treatment effects on factors/subscales were compared between drugs, correlations with changes in suicidal ideation were tested, and stepwise regression was used to derive predictors of change in SSI.
RESULTS


Factor scores for HDRS Psychic Depression, HDRS Anxiety, BDI Subjective Depression, POMS Depression and POMS Fatigue improved more with ketamine than midazolam. Stepwise regression showed across both drugs that improvement in HDRS Psychic Depression, POMS Depression, and HDRS Anxiety predicted 51.6% of the variance in reduction of suicidal ideation.
LIMITATIONS


Secondary analysis of clinical trial data.
CONCLUSIONS


Ketamine's rapid effects on suicidal ideation appear to be mostly a function of its effects on core mood and anxiety symptoms of MDD, with comparatively little contribution from neurovegetative symptoms with the potential exception of vigor/fatigue.
TRIAL REGISTRATION


Data used in this secondary analysis came from ClinicalTrials.gov identifier: NCT01700829.",2022,"Stepwise regression showed across both drugs that improvement in HDRS Psychic Depression, POMS Depression, and HDRS Anxiety predicted 51.6% of the variance in reduction of suicidal ideation.
",['patients with major depressive disorder (MDD'],"['subanesthetic ketamine', 'Ketamine', 'ketamine vs midazolam', 'midazolam', 'ketamine']","['suicidal ideation', 'factors/subscales', 'suicidal ideation examined changes in factor analysis-derived symptom clusters from standard measures of depression (Hamilton Depression Rating Scale, HDRS; Beck Depression Inventory, BDI) and mood disturbance (Profile of Mood States, POMS), and their relationship to severity of suicidal ideation (Beck Scale for Suicidal Ideation; SSI', 'HDRS Psychic Depression, POMS Depression, and HDRS Anxiety', 'Factor scores for HDRS Psychic Depression, HDRS Anxiety, BDI Subjective Depression, POMS Depression and POMS Fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085801', 'cui_str': 'Factor Analysis'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.185557,"Stepwise regression showed across both drugs that improvement in HDRS Psychic Depression, POMS Depression, and HDRS Anxiety predicted 51.6% of the variance in reduction of suicidal ideation.
","[{'ForeName': 'Annabella', 'Initials': 'A', 'LastName': 'Hochschild', 'Affiliation': 'Molecular Imaging and Neuropathology Division, New York State Psychiatric Institute, and Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Keilp', 'Affiliation': 'Molecular Imaging and Neuropathology Division, New York State Psychiatric Institute, and Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Madden', 'Affiliation': 'Molecular Imaging and Neuropathology Division, New York State Psychiatric Institute, and Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Ainsley K', 'Initials': 'AK', 'LastName': 'Burke', 'Affiliation': 'Molecular Imaging and Neuropathology Division, New York State Psychiatric Institute, and Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'J John', 'Initials': 'JJ', 'LastName': 'Mann', 'Affiliation': 'Molecular Imaging and Neuropathology Division, New York State Psychiatric Institute, and Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Grunebaum', 'Affiliation': 'Molecular Imaging and Neuropathology Division, New York State Psychiatric Institute, and Columbia University Irving Medical Center, New York, NY. Electronic address: Michael.grunebaum@nyspi.columbia.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2021.12.055']
1489,34933219,Influence of pre-treatment structural brain measures on effects of action-based cognitive remediation on executive function in partially or fully remitted patients with bipolar disorder.,"Cognitive impairment is an emerging treatment target in patients with bipolar disorder (BD) but so far, no evidence-based treatment options are available. Recent studies indicate promising effects of Cognitive Remediation (CR) interventions, but it is unclear who responds most to these interventions. This report aimed to investigate whether pre-treatment dorsal prefrontal cortex (dPFC) thickness predicts improvement of executive function in response to Action-Based Cognitive Remediation (ABCR) in patients with BD. Complete baseline magnetic resonance imaging (MRI) data were available from 45 partially or fully remitted patients with BD from our randomized controlled ABCR trial (ABCR: n = 25, control group: n = 20). We performed cortical reconstruction and volumetric segmentation using FreeSurfer. Multiple linear regression analysis was conducted to assess the influence of dPFC thickness on ABCR-related executive function improvement, reflected by change in the One Touch Stocking of Cambridge performance from baseline to post-treatment. We also conducted whole brain vertex wise analysis for exploratory purposes. Groups were well-matched for demographic and clinical variables. Less pre-treatment dPFC thickness was associated with greater effect of ABCR on executive function (p = 0.02). Further, whole-brain vertex analysis revealed an association between smaller pre-treatment superior temporal gyrus volume and greater ABCR-related executive function improvement. The observed associations suggest that structural abnormalities in dPFC and superior temporal gyrus are key neurocircuitry treatment targets for CR interventions that target impaired executive function in BD.",2022,Less pre-treatment dPFC thickness was associated with greater effect of ABCR on executive function (p = 0.02).,"['patients with BD', 'patients with bipolar disorder (BD', 'partially or fully remitted patients with bipolar disorder']","['Cognitive Remediation (CR) interventions', 'pre-treatment dorsal prefrontal cortex (dPFC) thickness', 'action-based cognitive remediation', 'Action-Based Cognitive Remediation (ABCR']","['executive function', 'Cognitive impairment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]",,0.0333609,Less pre-treatment dPFC thickness was associated with greater effect of ABCR on executive function (p = 0.02).,"[{'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Mogensen', 'Affiliation': 'Neurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Macoveanu', 'Affiliation': 'Neurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Knudsen', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet; Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'C V', 'Initials': 'CV', 'LastName': 'Ott', 'Affiliation': 'Neurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'K W', 'Initials': 'KW', 'LastName': 'Miskowiak', 'Affiliation': 'Neurocognition and Emotion in Affective Disorder (NEAD) Group, Copenhagen Affective Disorder research Centre (CADIC), Psychiatric Centre Copenhagen, Copenhagen University hospital, Rigshospitalet, Denmark; Department of Psychology, University of Copenhagen, Copenhagen, Denmark. Electronic address: kamilla.miskowiak@regionh.dk.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2021.11.010']
1490,34921796,"Efficacy and cost-effectiveness of task-shared care for people with severe mental disorders in Ethiopia (TaSCS): a single-blind, randomised, controlled, phase 3 non-inferiority trial.","BACKGROUND


There have been no trials of task-shared care (TSC) using WHO's mental health Gap Action Programme for people with severe mental disorders (psychosis or affective disorder) in low-income or middle-income countries. We aimed to evaluate the efficacy and cost-effectiveness of TSC compared with enhanced specialist mental health care in rural Ethiopia.
METHODS


In this single-blind, phase 3, randomised, controlled, non-inferiority trial, participants had a confirmed diagnosis of a severe mental disorder, recruited from either the community or a local outpatient psychiatric clinic. The intervention was TSC, delivered by supervised, non-physician primary health care workers trained in the mental health Gap Action Programme and working with community health workers. The active comparison group was outpatient psychiatric nurse care augmented with community lay workers (PSY). Our primary endpoint was whether TSC would be non-inferior to PSY at 12 months for the primary outcome of clinical symptom severity using the Brief Psychiatric Rating Scale, Expanded version (BPRS-E; non-inferiority margin of 6 points). Randomisation was stratified by health facility using random permuted blocks. Independent clinicians allocated groups using sealed envelopes with concealment and outcome assessors and investigators were masked. We analysed the primary outcome in the modified intention-to-treat group and safety in the per-protocol group. This trial is registered with ClinicalTrials.gov, number NCT02308956.
FINDINGS


We recruited participants between March 13, 2015 and May 21, 2016. We randomly assigned 329 participants (111 female and 218 male) who were aged 25-72 years and were predominantly of Gurage (198 [60%]), Silte (58 [18%]), and Mareko (53 [16%]) ethnicity. Five participants were found to be ineligible after randomisation, giving a modified intention-to-treat sample of 324. Of these, 12-month assessments were completed in 155 (98%) of 158 in the TSC group and in 158 (95%) of 166 in the PSY group. For the primary outcome, there was no evidence of inferiority of TSC compared with PSY. The mean BPRS-E score was 27·7 (SD 4·7) for TSC and 27·8 (SD 4·6) for PSY, with an adjusted mean difference of 0·06 (90% CI -0·80 to 0·89). Per-protocol analyses (n=291) were similar. There were 47 serious adverse events (18 in the TSC group, 29 in the PSY group), affecting 28 participants. These included 17 episodes of perpetrated violence and seven episodes of violent victimisation leading to injury, ten suicide attempts, six hospital admissions for physical health conditions, four psychiatric admissions, and three deaths (one in the TSC group, two in the PSY group). The incremental cost-effectiveness ratio for TSC indicated lower cost of -US$299·82 (95% CI -454·95 to -144·69) per unit increase in BPRS-E scores from a health care sector perspective at 12 months.
INTERPRETATION


WHO's mental health Gap Action Programme for people with severe mental disorders is as cost-effective as existing specialist models of care and can be implemented effectively and safely by supervised non-specialists in resource-poor settings.
FUNDING


US National Institute of Mental Health.",2022,"INTERPRETATION


WHO's mental health Gap Action Programme for people with severe mental disorders is as cost-effective as existing specialist models of care and can be implemented effectively and safely by supervised non-specialists in resource-poor settings.
","['people with severe mental disorders in Ethiopia (TaSCS', 'Five participants were found to be ineligible after randomisation, giving a modified intention-to-treat sample of 324', 'rural Ethiopia', 'people with severe mental disorders (psychosis or affective disorder) in low-income or middle-income countries', 'We recruited participants between March 13, 2015 and May 21, 2016', 'participants had a confirmed diagnosis of a severe mental disorder, recruited from either the community or a local outpatient psychiatric clinic', 'These included 17 episodes of perpetrated violence and seven episodes of violent victimisation leading to injury, ten suicide attempts, six hospital admissions for physical health conditions, four psychiatric admissions, and three deaths (one in the TSC group, two in the PSY group', 'people with severe mental disorders', '329 participants (111 female and 218 male) who were aged 25-72 years and were predominantly of Gurage (198 [60%]), Silte (58 [18%]), and Mareko (53 [16%]) ethnicity']","['psychiatric nurse care augmented with community lay workers (PSY', 'TSC', 'TSC, delivered by supervised, non-physician primary health care workers trained in the mental health Gap Action Programme and working with community health workers', ""task-shared care (TSC) using WHO's mental health Gap Action Programme"", 'task-shared care']","['mean BPRS-E score', 'inferiority of TSC', 'BPRS-E scores', '47 serious adverse events', 'efficacy and cost-effectiveness', 'Efficacy and cost-effectiveness', 'incremental cost-effectiveness ratio', 'clinical symptom severity using the Brief Psychiatric Rating Scale, Expanded version (BPRS-E; non-inferiority margin of 6 points']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}]","[{'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}]",329.0,0.398098,"INTERPRETATION


WHO's mental health Gap Action Programme for people with severe mental disorders is as cost-effective as existing specialist models of care and can be implemented effectively and safely by supervised non-specialists in resource-poor settings.
","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hanlon', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; Department of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Capacity-Building, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia. Electronic address: charlotte.hanlon@kcl.ac.uk.""}, {'ForeName': 'Girmay', 'Initials': 'G', 'LastName': 'Medhin', 'Affiliation': 'Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; Aklilu-Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Dewey', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Prince', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Esubalew', 'Initials': 'E', 'LastName': 'Assefa', 'Affiliation': 'Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; Department of Economics, College of Business and Economics, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Teshome', 'Initials': 'T', 'LastName': 'Shibre', 'Affiliation': 'Horizon, Fredericton, NB, Canada.'}, {'ForeName': 'Dawit A', 'Initials': 'DA', 'LastName': 'Ejigu', 'Affiliation': ""Department of Pharmacology, St Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Negussie', 'Affiliation': 'Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Sewit', 'Initials': 'S', 'LastName': 'Timothewos', 'Affiliation': 'Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Thornicroft', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; Centre for Implementation Science, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Wissow', 'Affiliation': 'Department of Psychiatry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ezra', 'Initials': 'E', 'LastName': 'Susser', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York NY, USA; New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Crick', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.""}, {'ForeName': 'Abebaw', 'Initials': 'A', 'LastName': 'Fekadu', 'Affiliation': 'Department of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Capacity-Building, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Atalay', 'Initials': 'A', 'LastName': 'Alem', 'Affiliation': 'Department of Psychiatry, World Health Organization Collaborating Centre for Mental Health Research and Capacity-Building, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}]",The lancet. Psychiatry,['10.1016/S2215-0366(21)00384-9']
1491,34922058,Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials.,"OBJECTIVES


This exploratory pooled analysis assessed the efficacy and safety of ceftaroline fosamil and comparators across six phase III clinical trials in adults with community-acquired pneumonia (CAP) or complicated skin and soft-tissue infection (cSSTI) and secondary bacteraemia.
METHODS


In each trial, FOCUS 1 and 2 (CAP), Asia CAP trial, CANVAS 1 and 2 (cSSTI) and COVERS (cSSTI), patients were randomised to ceftaroline fosamil [600 mg q12h by 1-h i.v. infusion, except in COVERS (600 mg q8h by 2-h i.v. infusion), adjusted for renal function] or comparator. Efficacy assessments included clinical and microbiological responses at test-of-cure visit [microbiological modified intent-to-treat (mMITT) population]. Safety outcomes were assessed.
RESULTS


The pooled mMITT population comprised 1976 patients, of whom 138 had baseline bacteraemia (ceftaroline fosamil, n = 72; comparator, n = 66). Predominant baseline blood pathogens were Staphylococcus aureus (n = 29), Streptococcus pneumoniae (n = 19) and other streptococci (n = 12). Clinical cure rates in bacteraemic patients were 55/72 (76.4%) and 51/66 (77.3%) for ceftaroline fosamil and comparators, respectively, and in non-bacteraemic patients were 822/966 (85.1%) and 717/872 (82.2%). Favourable microbiological response rates in bacteraemic patients were 56/72 (77.8%) for ceftaroline fosamil and 54/66 (81.8%) for comparators, and in non-bacteraemic patients were 825/966 (85.4%) and 719/872 (82.5%). Adverse events in bacteraemic patients were consistent with the known ceftaroline fosamil safety profile or the underlying indications.
CONCLUSION


These pooled clinical and microbiological efficacy data demonstrate generally favourable outcomes for ceftaroline fosamil in patients with CAP or cSSTI and secondary bacteraemia. [Trial Registration: NCT00621504, NCT00509106; NCT01371838; NCT00424190, NCT00423657; NCT01499277].",2021,"Favourable microbiological response rates in bacteraemic patients were 56/72 (77.8%) for ceftaroline fosamil and 54/66 (81.8%) for comparators, and in non-bacteraemic patients were 825/966 (85.4%) and 719/872 (82.5%), respectively.","['patients with CAP or cSSTI and secondary bacteraemia', '1976 patients, of whom 138 had baseline bacteraemia (ceftaroline fosamil, n=72; comparator, n=66', 'patients treated with ceftaroline fosamil', 'adults with community-acquired pneumonia (CAP) or complicated skin and soft tissue infection (cSSTI) and secondary bacteraemia', 'Staphylococcus aureus (n=29) and Streptococcus pneumoniae (n=19); other streptococci (n=12']","['ceftaroline fosamil', 'ceftaroline fosamil and comparator treatments', 'secondary bacteraemia']","['Predominant baseline blood pathogens', 'clinical and microbiological responses', 'Favourable microbiological response rates', 'Clinical cure rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C4727978', 'cui_str': 'Complicated skin and soft tissue infection'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2001525', 'cui_str': 'ceftaroline fosamil'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}]","[{'cui': 'C2001525', 'cui_str': 'ceftaroline fosamil'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}]",,0.220576,"Favourable microbiological response rates in bacteraemic patients were 56/72 (77.8%) for ceftaroline fosamil and 54/66 (81.8%) for comparators, and in non-bacteraemic patients were 825/966 (85.4%) and 719/872 (82.5%), respectively.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dryden', 'Affiliation': 'Royal Hampshire County Hospital, Romsey Road, Winchester SO22 5DG, UK. Electronic address: Matthew.Dryden@phe.gov.uk.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kantecki', 'Affiliation': 'Pfizer, Paris, France.'}, {'ForeName': 'Jean Li', 'Initials': 'JL', 'LastName': 'Yan', 'Affiliation': 'Pfizer, New York, New York, USA.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Stone', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Leister-Tebbe', 'Affiliation': 'Pfizer, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wilcox', 'Affiliation': 'Leeds Teaching Hospitals and University of Leeds, Leeds, UK.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2021.10.027']
1492,34928306,Assessment of Erenumab Safety and Efficacy in Patients With Migraine With and Without Aura: A Secondary Analysis of Randomized Clinical Trials.,"Importance


Migraine with aura may respond differently to therapies than migraine without aura. Individuals with migraine with aura have an elevated vascular risk, necessitating a safety assessment of migraine preventive treatments in this patient subgroup.
Objective


To assess the efficacy and safety profiles of erenumab in patients with migraine with aura.
Design, Setting, and Participants


This post hoc secondary analysis evaluated 4 double-blind, placebo-controlled randomized clinical trials that were conducted in treatment centers in North America, Europe, Russia, and Turkey between August 6, 2013, and November 12, 2019. Participants were adults aged 18 to 65 years with episodic migraine or chronic migraine and were randomized to receive either erenumab or placebo.
Interventions


One or more dose of erenumab (70 mg or 140 mg once per month) or placebo was administered by subcutaneous injection in the double-blind treatment phase and open-label or dose-blinded active treatment, and erenumab, 70 mg or 140 mg, was administered once per month by subcutaneous injection during extension phases.
Main Outcomes and Measures


Efficacy assessments included change from baseline monthly migraine days (MMDs) and monthly acute migraine-specific medication (AMSM) days. Safety end points included patient incidences of adverse events. Subgroups of patients were categorized according to their history of aura.
Results


Of the 2682 patients who were randomized in the 4 trials, 1400 (52.2%) received 1 or more dose of erenumab, 70 mg or 140 mg, and 1043 (38.9%) received placebo. Patients had a mean (SD) age of 41.7 (11.2) years and were predominantly women (n = 2055 [84.1%]). Reductions from baseline MMDs and AMSM days were greater in the erenumab than placebo groups in patients with and without a history of aura during the double-blind treatment phase, and these reductions were maintained throughout the extension phases. In patients with episodic migraine and a history of aura, least-squares mean differences in change from baseline MMDs at week 12 were -1.1 (95% CI, -1.7 to -0.6) in those who received erenumab, 70 mg, and -0.9 (95% CI, -1.6 to -0.2) in those who received erenumab, 140 mg, compared with placebo. In patients with chronic migraine with a history of aura, the least-squares mean differences from placebo treatment were -2.1 (95% CI, -3.8 to -0.5) in those who received erenumab, 70 mg, and -3.1 (95% CI, -4.8 to -1.4) in those who received erenumab, 140 mg. Overall safety profiles were similar across treatment groups regardless of aura history and were comparable to that of placebo over 12 weeks, with no increased emergence of adverse events over time.
Conclusions and Relevance


Results of this secondary analysis of 4 randomized clinical trials showed reduced migraine frequency and AMSM days with erenumab treatment in patients with migraine with and without a history of aura. The findings support the efficacy and safety of using erenumab in this patient population.
Trial Registration


ClinicalTrials.gov Identifiers: NCT01952574, NCT02456740, NCT02483585, NTCT02066415, and NCT02174861.",2022,"Overall safety profiles were similar across treatment groups regardless of aura history and were comparable to that of placebo over 12 weeks, with no increased emergence of adverse events over time.
","['treatment centers in North America, Europe, Russia, and Turkey between August 6, 2013, and November 12, 2019', 'patients with migraine with aura', 'patients with migraine with and without a history of aura', 'Patients With Migraine', 'Individuals with migraine with aura', '2682 patients who were randomized in the 4 trials, 1400 (52.2', 'Patients had a mean (SD) age of 41.7 (11.2) years and were predominantly women (n\u2009=\u20092055 [84.1', 'patients with chronic migraine with a history of aura', 'With and Without Aura', 'Participants were adults aged 18 to 65 years with episodic migraine or chronic migraine']","['placebo', 'erenumab', 'erenumab or placebo']","['Overall safety profiles', 'Main Outcomes and Measures\n\n\nEfficacy assessments included change from baseline monthly migraine days (MMDs) and monthly acute migraine-specific medication (AMSM) days', 'efficacy and safety', 'patient incidences of adverse events', 'emergence of adverse events', 'efficacy and safety profiles']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154723', 'cui_str': 'Migraine with aura'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517801', 'cui_str': '52.2'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2682.0,0.714521,"Overall safety profiles were similar across treatment groups regardless of aura history and were comparable to that of placebo over 12 weeks, with no increased emergence of adverse events over time.
","[{'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""National Institute for Health Research-Wellcome Trust King's Clinical Research Facility, King's College London, London, United Kingdom.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Department of Neurology, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Dartmouth College, Hanover, New Hampshire.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xue', 'Affiliation': 'Amgen Inc, Thousand Oaks, California.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Amgen Inc, Thousand Oaks, California.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Brennan', 'Affiliation': 'Amgen Inc, Thousand Oaks, California.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Paiva da Silva Lima', 'Affiliation': 'Amgen Inc, Thousand Oaks, California.'}]",JAMA neurology,['10.1001/jamaneurol.2021.4678']
1493,34896442,Comparative evaluation of different adhesive strategies of a universal adhesive in class II bulk-fill restorations: A 48-month randomized controlled trial.,"OBJECTIVES


To compare the clinical performance of the universal adhesive used in etch-and-rinse (ER) and self-etch (SE) adhesive strategies for 48-month in class II bulk-fill restorations.
METHODS


A total of 84 class II bulk-fill resin composite (Tetric EvoCeram Bulk Fill) restorations were placed in 35 participants by one operator using the universal adhesive's (Adhese Universal VivaPen) etch-and-rinse or self-etch mode randomly. The restorations were evaluated by two calibrated examiners at baseline and after 6-, 12-, 24-, 36- and 48-month using modified USPHS criteria. The comparison of the two adhesive strategies for each evaluation criteria was performed with the chi-square test. The baseline scores were compared with those at the recalls using the Friedman and Cochran's Q-test (p < .05).
RESULTS


At 48-month, 74 restorations were evaluated in 30 participants (recall rate: 85.7%). Marginal discoloration was statistically more frequent in SE approach (p < .05), whereas no significant difference was observed between the two strategies in terms of marginal adaptation (p > .05). There were statistically significant differences between the baseline and 48-month recall in the SE group in terms of marginal adaptation and discoloration (p < .05). In ER group, significant differences were found between baseline and 48-month only for marginal adaptation (p < .05). None of the restorations showed post-operative sensitivity. Secondary caries was observed in one restoration from SE group.
CONCLUSIONS


The tested bulk-fill restorative exhibited better clinical performance only in terms of marginal discoloration when the universal adhesive was used with ER strategy.
CLINICAL RELEVANCE


Though ER approach of the tested universal adhesive appears to be advantageous in terms of marginal discoloration, both adhesive strategies had similar impact on the clinical success of bulk-fill resin restorations.",2022,"The tested bulk-fill restorative exhibited better clinical performance only in terms of marginal discoloration when the universal adhesive was used with ER strategy.
","['48-month in class II bulk-fill restorations', ""A total of 84 class II bulk-fill resin composite (Tetric EvoCeram Bulk Fill) restorations were placed in 35 participants by one operator using the universal adhesive's (Adhese Universal VivaPen) etch-and-rinse or self-etch mode randomly"", 'class II bulk-fill restorations']",['universal adhesive used in etch-and-rinse (ER) and self-etch (SE) adhesive strategies'],"['Marginal discoloration', 'marginal adaptation', 'post-operative sensitivity', 'marginal adaptation and discoloration']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C1570772', 'cui_str': 'Tetric EvoCeram'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",74.0,0.066827,"The tested bulk-fill restorative exhibited better clinical performance only in terms of marginal discoloration when the universal adhesive was used with ER strategy.
","[{'ForeName': 'Ayse Ruya', 'Initials': 'AR', 'LastName': 'Yazici', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hacettepe University, Ankara 06100, Turkey.'}, {'ForeName': 'Aybuke', 'Initials': 'A', 'LastName': 'Uslu Tekce', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hacettepe University, Ankara 06100, Turkey.'}, {'ForeName': 'Zeynep Bilge', 'Initials': 'ZB', 'LastName': 'Kutuk', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hacettepe University, Ankara 06100, Turkey. Electronic address: zeynepbilge.kutuk@hacettepe.edu.tr.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103921']
1494,34935979,Neck Pain Clinical Prediction Rule to Prescribe Combined Aerobic and Neck-Specific Exercises: Secondary Analysis of a Randomized Controlled Trial.,"OBJECTIVE


A previous randomized controlled trial revealed that combined aerobic and neck-specific exercises yielded greater improvement than neck-specific exercises alone after a 6-month intervention in outpatients with nonspecific neck pain (NP). The aim of this secondary analysis was to identify subgroups of patients in the combined exercises group most likely to benefit from the intervention.
METHODS


Sixty-nine patients were included. The original trial was conducted in multiple physical therapy outpatient clinics twice a week for 6 weeks; follow-up was 6 months after assignment. The primary outcome was the therapeutic success rate (Global Rating of Change Score ≥ +5, ""quite a bit better"") after 6 weeks of training and at the 6-month follow-up. Candidate predictors from patients' medical history and physical examination were selected for univariable regression analysis to determine their association with treatment response status. Multivariable logistic regression analysis was used to derive preliminary clinical prediction rules.
RESULTS


The clinical prediction rule contained 3 predictor variables: (1) symptom duration ≤6 months, (2) neck flexor endurance ≥18 seconds, and (3) absence of referred pain (Nagelkerke R2 = .40 and -2 log likelihood = 60.30). The pre-test probability of success was 61.0% in the short term and 77.0% in the long term. The post-test probability of success for patients with at least 2 of the 3 predictor variables was 84.0% in the short term and 87.0% in the long term; such patients will likely benefit from this program.
CONCLUSION


A simple 3-item assessment, derived from easily obtainable baseline data, can identify patients with NP who may respond best to combined aerobic and neck-specific exercises. Validation is required before clinical recommendation.
IMPACT


Patients experiencing NP symptoms ≤6 months who have no referred pain and exhibit neck flexor endurance ≥18 seconds may benefit from a simple self-training program of combined aerobic and neck-specific exercises.",2022,The pre test probability of success was 61.0% in the short term and 77.0% in the long term.,"['patients with neck pain who may respond best to combined aerobic and neck-specific exercises', 'Patients experiencing neck pain symptoms ≤6\xa0months who have no referred pain and exhibit neck flexor endurance', 'Sixty-nine patients were included', 'outpatients with nonspecific neck pain']","['combined aerobic and neck-specific exercises', 'IMPACT', 'Prescribe Combined Aerobic and Neck-Specific Exercises']","['pre test probability of success', 'therapeutic success rate (Global Rating of Change Score\u2009≥\u2009+5, ""quite a bit better', '2) neck flexor endurance ≥18\xa0s, and (3) absence of referred pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0234250', 'cui_str': 'Referred pain'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0045724', 'cui_str': '2-(4-ethoxybenzyl)-1-diethylaminoethyl-5-isothiocyanatobenzimidazole'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0234250', 'cui_str': 'Referred pain'}]",69.0,0.0775307,The pre test probability of success was 61.0% in the short term and 77.0% in the long term.,"[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Daher', 'Affiliation': 'Department of Physical Therapy, Zefat Academic College, Safed, Israel.'}, {'ForeName': 'Rafael S', 'Initials': 'RS', 'LastName': 'Carel', 'Affiliation': 'School of Public Health, University of Haifa, Mount Carmel, Haifa, Israel.'}, {'ForeName': 'Gali', 'Initials': 'G', 'LastName': 'Dar', 'Affiliation': 'Department of Physical Therapy, Faculty of Social Welfare and Health Studies, University of Haifa, Mount Carmel, Haifa, Israel.'}]",Physical therapy,['10.1093/ptj/pzab269']
1495,34925697,"The Role of RIPC in Preventing Organ Damage, Inflammation, and Oxidative Stress during Lower Limb DSA: A Randomised Controlled Trial.","Objective


Diagnostic digital subtraction angiography (DSA) and DSA with percutaneous transluminal angioplasty (DSA-PTA) are common procedures for diagnosing and treating symptomatic lower extremity arterial disease (LEAD). However, organ damage following DSA and DSA-PTA is often underrecognised and hence undiagnosed. To reduce the risk induced by invasive procedures in symptomatic LEAD patients, the method of remote ischemic preconditioning (RIPC) has been suggested. The aim of the current study was to assess the effect of RIPC intervention on the organ damage markers profile, oxidative stress, and inflammation biomarkers in LEAD patients undergoing DSA and DSA-PTA procedure.
Methods


The RIPC intervention was performed by inflating a standard blood pressure cuff on the patient's upper arm to 200 mmHg for 5 minutes four times with 5-minute perfusion between each cycle. The sham intervention was performed similarly, but the cuff was inflated to 20 mmHg. Changes in the cardiac and renal damage biomarkers' profile, oxidative stress, and inflammation biomarkers were recorded before and 24 hours after DSA or DSA-PTA.
Results


A total of 111 (RIPC 54, sham 57) patients with symptomatic LEAD scheduled for endovascular procedure were randomised, and 102 patients (RIPC 47, sham 55) completed the study protocol. RIPC significantly limited the increase of adiponectine levels after DSA and DSA-PTA, compared to sham intervention ( p  = 0.020), but CK-MB levels were markedly lower in the sham group ( p  = 0.047) after procedure. There was no significant difference between the RIPC and the sham group in mean changes in hs-troponin-T ( p  = 0.25), NT-proBNP ( p  = 0.24), creatinine ( p  = 0.76), eGFR ( p  = 0.61), urea ( p  = 0.95), beta-2-microglobuline ( p  = 0.34), or cystatine C ( p  = 0.24) levels.
Conclusion


In this controlled clinical study, RIPC failed to improve the profile of renal and cardiac biomarkers in patients with LEAD periprocedurally. RIPC significantly limits the rise in adiponectin levels and may influence the decrease of CK-MB levels 24 hours after endovascular procedure.",2021,"RIPC significantly limited the increase of adiponectine levels after DSA and DSA-PTA, compared to sham intervention ( p  = 0.020), but CK-MB levels were markedly lower in the sham group ( p  = 0.047) after procedure.","['symptomatic LEAD patients', 'LEAD patients undergoing DSA and DSA-PTA procedure', 'A total of 111 (RIPC 54, sham 57) patients with symptomatic LEAD scheduled for endovascular procedure were randomised, and 102 patients (RIPC 47, sham 55) completed the study protocol', 'Lower Limb DSA', 'patients with LEAD periprocedurally']","['RIPC', 'Diagnostic digital subtraction angiography (DSA) and DSA with percutaneous transluminal angioplasty (DSA-PTA', 'RIPC intervention']","['Organ Damage, Inflammation, and Oxidative Stress', 'NT-proBNP', ""cardiac and renal damage biomarkers' profile, oxidative stress, and inflammation biomarkers"", 'organ damage markers profile, oxidative stress, and inflammation biomarkers', 'adiponectin levels', 'mean changes in hs-troponin-T', 'eGFR', 'adiponectine levels', 'profile of renal and cardiac biomarkers', 'beta-2-microglobuline', 'CK-MB levels']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0852949', 'cui_str': 'Disorder of artery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002979', 'cui_str': 'Digital subtraction angiography'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C2936204', 'cui_str': 'Intravascular Techniques'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002979', 'cui_str': 'Digital subtraction angiography'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}]",,0.143104,"RIPC significantly limited the increase of adiponectine levels after DSA and DSA-PTA, compared to sham intervention ( p  = 0.020), but CK-MB levels were markedly lower in the sham group ( p  = 0.047) after procedure.","[{'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Kuusik', 'Affiliation': 'Department of Cardiology, Institute of Clinical Medicine, University of Tartu, Puusepa 8, Tartu 50406, Estonia.'}, {'ForeName': 'Teele', 'Initials': 'T', 'LastName': 'Kasepalu', 'Affiliation': 'Heart Clinic, Tartu University Hospital, Puusepa 8, Tartu 50406, Estonia.'}, {'ForeName': 'Mihkel', 'Initials': 'M', 'LastName': 'Zilmer', 'Affiliation': 'Department of Biochemistry, Institute of Biomedicine and Translational Medicine, Centre of Excellence for Genomics and Translational Medicine, University of Tartu, Puusepa 8, Tartu 50406, Estonia.'}, {'ForeName': 'Jaan', 'Initials': 'J', 'LastName': 'Eha', 'Affiliation': 'Department of Cardiology, Institute of Clinical Medicine, University of Tartu, Puusepa 8, Tartu 50406, Estonia.'}, {'ForeName': 'Mare', 'Initials': 'M', 'LastName': 'Vähi', 'Affiliation': 'Institute of Mathematics and Statistics, University of Tartu, J. Liivi 2, Tartu 50409, Estonia.'}, {'ForeName': 'Liisi Anette', 'Initials': 'LA', 'LastName': 'Torop', 'Affiliation': 'Pathology Service, Tartu University Hospital, Puusepa 8, Tartu 50406, Estonia.'}, {'ForeName': 'Jüri', 'Initials': 'J', 'LastName': 'Lieberg', 'Affiliation': 'Department of Vascular Surgery, Surgery Clinic, Tartu University Hospital, Puusepa 8, Tartu 50406, Estonia.'}, {'ForeName': 'Jaak', 'Initials': 'J', 'LastName': 'Kals', 'Affiliation': 'Department of Biochemistry, Institute of Biomedicine and Translational Medicine, Centre of Excellence for Genomics and Translational Medicine, University of Tartu, Puusepa 8, Tartu 50406, Estonia.'}]",Oxidative medicine and cellular longevity,['10.1155/2021/6043550']
1496,34939347,"Effect of Artificial Tiger Bone Powder (Jintiange Capsule®) on Vertebral Height Ratio, Cobb's Angle, Bone Mineral Density, and Visual Analog Score.","OBJECTIVES


To investigate the effect of Jintiange capsule on acute bone atrophy (vertebral height, Cobb's angle, bone mineral density, and visual analog score (VAS) in patients with osteoporotic vertebral compression fracture.
METHODS


A total of 106 patients with osteoporotic vertebral compression fractures were selected and randomly divided into study and control group. Vertebral height ratio (VHR), Cobb's angle, bone mineral density (BMD), and VAS analyses were performed as study indexes. The study was performed from January 2019 to December 2019 as a double-blind, randomized, controlled trial and all the participants were blinded throughout the study. There were 24 males and 29 females in the study group, with 14 cases of thoracic fractures and 39 cases of lumbar fractures. The age was 61-75 years, with an average of 67.5 ± 2.7 years, and the course of disease was 1-9 days, with an average of 2.7 ± 0.5 days. There were 22 males and 31 females in the control group, with 17 cases of thoracic fractures and 36 cases of lumbar fractures. Patients in the control group received conventional postoperative treatment, while patients in the study group were treated with Jintiange capsule. The treatment continued for 3 months. The ages of the participants were from 60 to 70 years, while the average ages of both groups were 67 ± 2.8 years and the study recruited participants of both sexes.
RESULTS


The clinical efficacy, vertebral imaging indexes before and after treatment, as well as pain and daily activity dysfunction scores were compared. The effect of the Jintiange capsule was followed for 3 months and both the groups were compared. The total effective score of the study group was significantly increased (90.6%) in contrast to the control group (67.9) and the P value was less than the 0.5. The vertebral height and bone mineral density of the study group was significantly improved compared to the control group (P < 0.034) using t-test. However, the Cobb's angle of the study group was significantly (P < 0.047) lower than the control group using t-test after the treatment. On the other hand, the VAS score and Oswestry score of the study group were significantly lower than control group at 1 month and 3 months after treatment (P < 0.05). There was no significance difference (all P > 0.05) in term of gender and ages in both the recruited groups.
CONCLUSION


It can be concluded that Jintiange capsule can significantly improve the clinical efficacy rate, vertebral height, Cobb's angle, and bone mineral density, pain relief, and daily activity function.",2022,The total effective score of the study group was significantly increased (90.6%) in contrast to the control group (67.9) and the P value was less than the 0.5.,"['106 patients with osteoporotic vertebral compression fractures', 'The age was 61-75\u2009years, with an average of 67.5 ±\u20092.7\u2009years, and the course of disease was 1-9\u2009days, with an average of 2.7 ±\u20090.5\u2009days', '22 males and 31 females in the control group, with 17 cases of thoracic fractures and 36 cases of lumbar fractures', 'patients with osteoporotic vertebral compression fracture', '24 males and 29 females in the study group, with 14 cases of thoracic fractures and 39 cases of lumbar fractures', 'The ages of the participants were from 60 to 70\u2009years, while the average ages of both groups were 67 ±\u20092.8\u2009years and the study recruited participants of both sexes']","['Artificial Tiger Bone Powder (Jintiange Capsule®', 'conventional postoperative treatment', 'Jintiange capsule']","[""Vertebral height ratio (VHR), Cobb's angle, bone mineral density (BMD), and VAS analyses"", 'total effective score', ""Vertebral Height Ratio, Cobb's Angle, Bone Mineral Density, and Visual Analog Score"", ""acute bone atrophy (vertebral height, Cobb's angle, bone mineral density, and visual analog score (VAS"", 'vertebral height and bone mineral density', 'clinical efficacy, vertebral imaging indexes', 'VAS score and Oswestry score', 'pain and daily activity dysfunction scores', ""clinical efficacy rate, vertebral height, Cobb's angle, and bone mineral density, pain relief, and daily activity function""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0262544', 'cui_str': 'Fracture of lumbar spine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0325115', 'cui_str': 'Panthera tigris'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1389037', 'cui_str': 'Bone atrophy'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",106.0,0.0362198,The total effective score of the study group was significantly increased (90.6%) in contrast to the control group (67.9) and the P value was less than the 0.5.,"[{'ForeName': 'Long-Jun', 'Initials': 'LJ', 'LastName': 'Shu', 'Affiliation': ""Department of Orthopaedics, The First People's Hospital of Dali City, Yunnan, China.""}, {'ForeName': 'Ji-Yuan', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics, The First People's Hospital of Dali City, Yunnan, China.""}]",Orthopaedic surgery,['10.1111/os.13121']
1497,34937678,"Reply to Deepansh Dalela and Kristina Suson's Letter to the Editor re: Luke Harper, T. Blanc, M. Peycelon, et al. Circumcision and Risk of Febrile Urinary Tract Infection in Boys with Posterior Urethral Valves: Result of the CIRCUP Randomized Trial. Eur Urol. 2022;81:64-72.",,2022,,['Boys with Posterior Urethral Valves'],[],[],"[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0238506', 'cui_str': 'Congenital posterior urethral valves'}]",[],[],,0.0974098,,"[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': 'Department of Pediatric Surgery, CHU F. Guyon, Bordeaux, France. Electronic address: harper_luke@hotmail.com.'}]",European urology,['10.1016/j.eururo.2021.12.001']
1498,34906619,"Comparison of general satisfaction, oral health-related quality of life, and patient's self-assessment between mandibular single-implant overdentures and experimental removable complete dentures: A randomized crossover clinical trial.","Objective Patient satisfaction with single-implant overdentures (1-IODs) is unclear. This randomized crossover trial aimed to compare the general satisfaction, oral health-related quality of life, and patients' self-assessment between mandibular 1-IODs and experimental removable complete dentures (eRCDs). Methods New mandibular RCDs were fabricated for 22 patients with edentulous mandibles. After adapting to the RCDs, one implant was inserted in the mandibular midline. The participants were then randomly classified into groups 1 and 2. Group 1 received IODs for the first 2 months, while group 2 used eRCDs with a non-loaded implant in the midline. After 2 months, the treatment was switched. Four validated, patient-reported dental outcome measures were assessed: general satisfaction, Japanese version of the Oral Health Impact Profile for edentulous subjects (OHIP EDENT-J), General Oral Health Assessment Index (GOHAI), and Patient's Denture Assessment (PDA). The assessments were performed at the end of the IOD- and eRCD- use periods. Results General satisfaction was significantly higher during the IOD period (p = 0.002). Significant differences were observed in all domains of the OHIP, except orofacial pain (p = 0.084). Further, the total score (p<0.001) and the scores of the physical (p<0.001) and psychosocial functioning (p = 0.001) domains of the GOHAI differed significantly. The total PDA score (p = 0.001) and the scores of the function (p = 0.004), lower denture (p = 0.002), esthetics and speech (p = 0.026), and importance (p = 0.009) domains were significantly higher during the IOD period than during the eRCD period. Conclusion General satisfaction, oral health-related quality of life, and patient self-assessment scores were significantly higher for 1-IODs than for eRCDs. Clinical significance Within the limitations of this study, we found that mandibular single-implant overdentures may be an efficient alternative to mandibular experimental removable complete dentures due to higher general satisfaction, oral health-related quality of life, and patient self-assessment scores of dentures.",2022,"Significant differences were observed in all domains of the OHIP, except orofacial pain (p = 0.084).","['22 patients with edentulous mandibles', 'mandibular single-implant overdentures and experimental removable complete dentures']","['mandibular 1-IODs and experimental removable complete dentures (eRCDs', 'single-implant overdentures (1-IODs']","[""general satisfaction, Japanese version of the Oral Health Impact Profile for edentulous subjects (OHIP EDENT-J), General Oral Health Assessment Index (GOHAI), and Patient's Denture Assessment (PDA"", ""general satisfaction, oral health-related quality of life, and patient's self-assessment"", 'Conclusion General satisfaction, oral health-related quality of life, and patient self-assessment scores', 'esthetics and speech', 'total PDA score', 'scores of the physical (p<0.001) and psychosocial functioning', 'General satisfaction', 'OHIP, except orofacial pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3853359', 'cui_str': 'Edentulous mandible'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}]","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0178782', 'cui_str': 'Orofacial Pain'}]",22.0,0.0372463,"Significant differences were observed in all domains of the OHIP, except orofacial pain (p = 0.084).","[{'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Uehara', 'Affiliation': 'Department of Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University,1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kanazawa', 'Affiliation': 'Department of Digital Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University,1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan. Electronic address: m.kanazawa.gerd@tmd.ac.jp.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Miyayasu', 'Affiliation': 'Department of Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University,1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University,1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan.'}, {'ForeName': 'Awutsadaporn', 'Initials': 'A', 'LastName': 'Katheng', 'Affiliation': 'Department of Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University,1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sato', 'Affiliation': 'Department of Implant Dentistry, School of Dentistry, Showa University, 1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Minakuchi', 'Affiliation': 'Department of Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University,1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103920']
1499,34941445,Getting Creative: Pilot Study of a Coached Writing Intervention in Patients with Advanced Cancer at a Rural Academic Medical Center.,"Background:  Unfacilitated writing activities, such as expressive writing, have not shown benefit in people with advanced cancer, but facilitated writing activities have yet to be fully explored.  Objectives:  To assess the feasibility and acceptability of facilitated writing activities determined by a writing coach in people with advanced incurable cancer.  Design:  This is a single-arm pilot study.  Settings/Subjects:  Adult patients with advanced incurable solid malignancies from a U.S. rural comprehensive cancer program met with a writing coach monthly for at least three months for facilitated writing activities.  Measurements:  Feasibility was assessed by enrollment and postinclusion attrition rate. Acceptability was assessed by (1) <15% drop out rate due to the intervention, (2) <15% elevated anxiety or depression due to the intervention, and (3) patient qualitative comments.  Results:  In total, 22 out of 63 patients consented (35%). Postinclusion attrition rate was 18% ( n  = 4) at three months with 82% completing at least three months of the writing coach intervention. No participants dropped out or had elevated anxiety/depression due to the intervention. The majority of patients wanted the whole intervention continued.  Conclusions:  A writing coach using facilitated writing activities was feasible and acceptable in patients with advanced incurable cancer, but further studies are needed to assess impact. Clinical Trial Registration Number NCT 025 75898.",2022,To assess the feasibility and acceptability of facilitated writing activities determined by a writing coach in people with advanced incurable cancer.  ,"['Settings/Subjects:  Adult patients with advanced incurable solid malignancies from a U.S. rural comprehensive cancer program', 'Patients with Advanced Cancer at a Rural Academic Medical Center', 'people with advanced cancer', 'people with advanced incurable cancer', 'patients with advanced incurable cancer']",['Coached Writing Intervention'],"['feasibility and acceptability of facilitated writing activities', 'Postinclusion attrition rate', 'elevated anxiety/depression', 'anxiety or depression', 'Acceptability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",63.0,0.252423,To assess the feasibility and acceptability of facilitated writing activities determined by a writing coach in people with advanced incurable cancer.  ,"[{'ForeName': 'Maxwell T', 'Initials': 'MT', 'LastName': 'Vergo', 'Affiliation': 'Department of Medicine and Section of Palliative Medicine, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Marv', 'Initials': 'M', 'LastName': 'Klassen-Landis', 'Affiliation': 'Family Support Services, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Meilin', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Section of Palliative Care and Medical Ethics, UPMC Health Systems, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}]",Journal of palliative medicine,['10.1089/jpm.2021.0335']
1500,34930299,"Contributions of changes in physical activity, sedentary time, diet and body weight to changes in cardiometabolic risk.","BACKGROUND


Increased physical activity (PA), reduced time spent sedentary (SED), healthier diet and reduced body weight may all have a positive impact on cardiometabolic risk. The relative importance of change in each of these variables on cardiometabolic risk, however, is unclear. We therefore sought to investigate the relative contributions of changes in PA, SED, diet and body weight on cardiometabolic risk.
METHODS


This is a secondary analysis of data collected from the EuroFIT randomised controlled trial, which was a 12-week group-based lifestyle intervention for overweight middle-aged men delivered by coaches in football club stadia aiming to improve PA, SED, diet, and body weight. PA and SED were assessed by accelerometry, diet using the Dietary Instrument for Nutrition Education (DINE). An overall cardiometabolic risk score was derived from combining z-scores for glucose, HbA1c, insulin, lipids and blood pressure. In total, 707 men (from the overall cohort of 1113) with complete data for these variables at baseline and 12-month follow-up were included in the multivariable linear regression analyses.
RESULTS


In multivariable analyses, change in number of steps (explaining 5.1% of R 2 ) and dietary factors (less alcohol, fatty and sugary food, and more fruit and vegetables) (together explaining 4.5% of R 2 ), but not changes in standing time or SED, were significantly associated with change in body weight. Changes in number of steps (R 2  = 1.7%), fatty food score (R 2  = 2.4%), and sugary food score (R 2  = 0.4%) were significantly associated with change in cardiometabolic risk score in univariable models. However, in multivariable models which included changes in weight as well as changes in steps and dietary variables, change in weight explained a substantially larger proportion of the change in cardiometabolic risk score, explaining 14.1% of R 2  (out of an overall model R 2  of 19.0%). When baseline (as well as change) values were also included in the model, 38.8% of R 2  for change in cardiometabolic risk score was explained overall, with 14.1% of R 2  still explained by change in weight.
CONCLUSION


Change in body weight, together with baseline cardiometabolic risk explained most of the change in cardiometabolic risk. Thus, the benefits of increasing physical activity and improving diet on cardiometabolic risk appear to act largely via an effect on changes in body weight.
TRIAL REGISTRATION


International Standard Randomised Controlled Trials, ISRCTN-81935608. Registered 06052015. https://www.isrctn.com/ISRCTN81935608?q=&filters=recruitmentCountry:Portugal&sort=&offset=7&totalResults=92&page=1&pageSize=10&searchType=basic-search.",2021,"Changes in number of steps (R 2  = 1.7%), fatty food score (R 2  = 2.4%), and sugary food score (R 2  = 0.4%) were significantly associated with change in cardiometabolic risk score in univariable models.","['overweight middle-aged men delivered by coaches in football club stadia aiming to improve PA, SED, diet, and body weight', '707 men (from the overall cohort of 1113) with complete data for these variables at baseline and 12-month follow-up']",['lifestyle intervention'],"['sugary food score', 'glucose, HbA1c, insulin, lipids and blood pressure', 'dietary factors (less alcohol, fatty and sugary food, and more fruit and vegetables', 'fatty food score', 'standing time or SED', 'physical activity, sedentary time, diet and body weight to changes in cardiometabolic risk', 'number of steps', 'body weight', 'physical activity (PA), reduced time spent sedentary (SED), healthier diet and reduced body weight', 'cardiometabolic risk score', 'overall cardiometabolic risk score', 'PA and SED']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0453425', 'cui_str': 'Sugary food'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0453819', 'cui_str': 'Fatty food'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",707.0,0.0667582,"Changes in number of steps (R 2  = 1.7%), fatty food score (R 2  = 2.4%), and sugary food score (R 2  = 0.4%) were significantly associated with change in cardiometabolic risk score in univariable models.","[{'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Andersen', 'Affiliation': 'Institute for Sport and Social Science, Norwegian School of Sport Science, PO box 4014, Ullevål stadium, 0806, Oslo, Norway. Eivind.andersen@usn.no.'}, {'ForeName': 'Hidde P', 'Initials': 'HP', 'LastName': 'van der Ploeg', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'van Mechelen', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Mutrie', 'Affiliation': 'Physical Activity for Health Research Centre, the University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'van Nassau', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Judith G M', 'Initials': 'JGM', 'LastName': 'Jelsma', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Annie S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Centre for Public Health Nutrition Research, University of Dundee, Dundee, UK.'}, {'ForeName': 'Marlene N', 'Initials': 'MN', 'LastName': 'Silva', 'Affiliation': 'CIDEFES, Faculdade de Educação Física e Desporto, Universidade Lusófona, Lisboa, Portugal.'}, {'ForeName': 'Hugo V', 'Initials': 'HV', 'LastName': 'Pereira', 'Affiliation': 'CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Sørensen', 'Affiliation': 'Institute for Sport and Social Science, Norwegian School of Sport Science, PO box 4014, Ullevål stadium, 0806, Oslo, Norway.'}, {'ForeName': 'Øystein B', 'Initials': 'ØB', 'LastName': 'Røynesdal', 'Affiliation': 'Institute for Sport and Social Science, Norwegian School of Sport Science, PO box 4014, Ullevål stadium, 0806, Oslo, Norway.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hunt', 'Affiliation': 'Institute for Social Marketing and Health, University of Stirling, Stirling, UK.'}, {'ForeName': 'Glyn C', 'Initials': 'GC', 'LastName': 'Roberts', 'Affiliation': 'Institute for Sport and Social Science, Norwegian School of Sport Science, PO box 4014, Ullevål stadium, 0806, Oslo, Norway.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jason M R', 'Initials': 'JMR', 'LastName': 'Gill', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-021-01237-1']
1501,34954718,Effect of HIV Self-Testing on PrEP Adherence Among Gender-Diverse Sex Workers in Uganda: A Randomized Trial.,"BACKGROUND


HIV self-testing (HIVST) and pre-exposure prophylaxis (PrEP) are complementary tools that could empower sex workers to control their HIV protection, but few studies have jointly evaluated PrEP and HIVST in any setting.
METHODS


The Empower Study was an open-label randomized trial in Uganda. Sex workers were offered F/tenofovir disoproxil fumarate and randomized 1:1 to monthly HIVST and quarterly in-clinic testing (intervention) or quarterly in-clinic HIV testing alone (standard of care) and followed up for 12 months. PrEP adherence was measured using electronic adherence monitoring and tenofovir diphosphate (TFV-DP) levels in dried blood spots. Adherence outcomes and sexual behaviors were compared by arm using generalized estimating equation models.
RESULTS


We enrolled 110 sex workers: 84 cisgender women, 14 transgender women, 10 men who have sex with men, and 2 transgender men. The median age was 23 years. The 12-month retention was 75%. Nearly all (99.4%) used ≥1 HIVST kit. The proportion with TFV-DP levels ≥700 fmol/punch in the HIVST and standard of care arms at the 3-, 6-, 9-, and 12-month visits was 2.4%, 2.3%, 0%, and 0% and 7.9%, 0%, 0%, and 0%, respectively, with no differences by randomization arm (P > 0.2). Self-reported condomless sex acts with paying partners was similar by arm [adjusted incidence rate ratio 0.70; 95% confidence interval (CI): 0.42 to 1.17; P = 0.18]. One seroconversion occurred (HIV incidence, 0.9/100 person-years); TFV-DP was not detected at any visit.
CONCLUSIONS


A gender-diverse sample of sex workers in Uganda used HIVST but not daily oral PrEP for HIV protection. Alternate approaches to promote PrEP use, including long-acting formulations, should be considered in this population.",2022,"One seroconversion occurred (HIV incidence, 0.9/100 person-years); TFV-DP was not detected at any visit.
","['Sex workers', 'Median age was 23 years', '110 sex workers: 84 cisgender women, 14 transgender women, 10 men who have sex with men and two transgender men', 'Gender Diverse Sex Workers in Uganda']","['HIVST and quarterly in-clinic testing (intervention) or quarterly in-clinic HIV testing alone (standard-of-care', 'HIV self-testing (HIVST) and pre-exposure prophylaxis (PrEP', 'HIV Self-Testing on PrEP']","['proportion with TFV-DP levels ≥700', 'Adherence outcomes and sexual behaviors', 'electronic adherence monitoring and tenofovir diphosphate (TFV-DP) levels', 'PrEP adherence']","[{'cui': 'C0240816', 'cui_str': 'Sex worker'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0618884', 'cui_str': 'IS 23'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C3712637', 'cui_str': 'tenofovir diphosphate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]",110.0,0.0423175,"One seroconversion occurred (HIV incidence, 0.9/100 person-years); TFV-DP was not detected at any visit.
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mujugira', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Nakyanzi', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Nabaggala', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Muwonge', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Ssebuliba', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bagaya', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Nampewo', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sapiri', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Kikulwe R', 'Initials': 'KR', 'LastName': 'Nyanzi', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Bambia', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Rogers', 'Initials': 'R', 'LastName': 'Nsubuga', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Serwadda', 'Affiliation': 'Department of Disease Control and Environmental Health, School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Norma C', 'Initials': 'NC', 'LastName': 'Ware', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA; and.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002895']
1502,34878526,Stratified Care vs Stepped Care for Depression: A Cluster Randomized Clinical Trial.,"Importance


Depression is a major cause of disability worldwide. Although empirically supported treatments are available, there is scarce evidence on how to effectively personalize psychological treatment selection.
Objective


To compare the clinical effectiveness and cost-effectiveness of 2 treatment selection strategies: stepped care and stratified care.
Design, Setting, and Participants


This multisite, cluster randomized clinical trial recruited participants from the English National Health Service from July 5, 2018, to February 1, 2019. Thirty clinicians working across 4 psychological therapy services were randomly assigned to provide stratified (n = 15) or stepped (n = 15) care. In stepped care, patients sequentially access low-intensity guided self-help followed by high-intensity psychotherapy. In stratified care, patients are matched with either low- or high-intensity treatments at initial assessment. Data were analyzed from May 18, 2020, to October 13, 2021, using intention-to-treat principles.
Interventions


All clinicians used the same interview schedule to conduct initial assessments with patients seeking psychological treatment for common mental disorders, but those in the stratified care group received a personalized treatment recommendation for each patient generated by a machine learning algorithm. Eligible patients received either stratified or stepped care (ie, treatment as usual).
Main Outcomes and Measures


The preregistered outcome was posttreatment reliable and clinically significant improvement (RCSI) of depression symptoms (measured using the 9-item Patient Health Questionnaire). The RCSI outcome was compared between groups using logistic regression adjusted for baseline severity. Cost-effectiveness analyses compared incremental costs and health outcomes of the 2 treatment pathways.
Results


A total of 951 patients were included (618 women among 950 with data available [65.1%]; mean [SD] age, 38.27 [14.53] years). The proportion of cases of RCSI was significantly higher in the stratified care arm compared with the stepped care arm (264 of 505 [52.3%] vs 134 of 297 [45.1%]; odds ratio, 1.40 [95% CI, 1.04-1.87]; P = .03). Stratified care was associated with a higher mean additional cost per patient (£104.5 [95% CI, £67.5-£141.6] [$139.83 (95% CI, $90.32-$189.48)]; P < .001) because more patients accessed high-intensity treatments (332 of 583 [56.9%] vs 107 of 368 [29.1%]; χ2 = 70.51; P < .001), but this additional cost resulted in an approximately 7% increase in the probability of RCSI.
Conclusions and Relevance


In this cluster randomized clinical trial of adults with common mental disorders, stratified care was efficacious and cost-effective for the treatment of depression symptoms compared with stepped care. Stratified care can improve depression treatment outcomes at a modest additional cost.
Trial Registration


isrctn.org Identifier: ISRCTN11106183.",2022,"In this cluster randomized clinical trial of adults with common mental disorders, stratified care was efficacious and cost-effective for the treatment of depression symptoms compared with stepped care.","['Thirty clinicians working across 4 psychological therapy services', 'A total of\u2009951 patients were included (618 women among 950 with data available [65.1%]; mean [SD] age,\u200938.27 [14.53] years', 'participants from the English National Health Service from July 5, 2018, to February 1, 2019', 'adults with common mental disorders']","['personalized treatment recommendation for each patient generated by a machine learning algorithm', 'Stratified Care vs Stepped Care']","['clinical effectiveness and cost-effectiveness', 'posttreatment reliable and clinically significant improvement (RCSI) of depression symptoms (measured using the 9-item Patient Health Questionnaire', 'proportion of cases of RCSI', 'probability of RCSI']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",951.0,0.189031,"In this cluster randomized clinical trial of adults with common mental disorders, stratified care was efficacious and cost-effective for the treatment of depression symptoms compared with stepped care.","[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Delgadillo', 'Affiliation': 'Clinical and Applied Psychology Unit, Department of Psychology, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Fleck', 'Affiliation': 'Lancashire and South Cumbria NHS Foundation Trust, Preston, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Agnew', 'Affiliation': 'Lancashire and South Cumbria NHS Foundation Trust, Preston, United Kingdom.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Southgate', 'Affiliation': 'Rotherham Doncaster and South Humber NHS Foundation Trust, Doncaster, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Parkhouse', 'Affiliation': 'Rotherham Doncaster and South Humber NHS Foundation Trust, Doncaster, United Kingdom.'}, {'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychiatry, University of California, Los Angeles.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'DeRubeis', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Barkham', 'Affiliation': 'Clinical and Applied Psychology Unit, Department of Psychology, University of Sheffield, Sheffield, United Kingdom.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2021.3539']
1503,34887285,Protocol for a pilot randomised controlled trial of zoledronic acid to prevent bone loss following sleeve gastrectomy surgery.,"INTRODUCTION


Sleeve gastrectomy (SG) is an increasingly used and effective treatment for obesity; however, the rapid weight loss associated with SG adversely affects bone metabolism predisposing patients to skeletal fragility. Bisphosphonate medications have been evaluated for safety and efficacy in combating bone loss in patients with osteoporosis, but their use in SG-induced bone loss is limited. The goal of this study is to investigate how a one-time infusion of zoledronic acid compares to placebo, in its ability to combat SG-associated bone loss.
METHODS AND ANALYSIS


This research protocol is a 9-month, pilot randomized controlled trial (RCT) involving 30 adult SG patients randomised to receive an infusion of either 5 mg of zoledronic acid or placebo, 6 weeks following surgery. To be included participants must be <350 lbs/158.8 kg, free of bone-impacting pathologies or medications, and must have adequate serum calcium and vitamin D levels at baseline. The primary outcome is change in areal bone mineral density (aBMD) at the total hip. Secondary outcomes include change in aBMD of the femoral neck, and lumbar spine, and change in volumetric BMD at the lumbar spine. The primary aim will be tested using a linear mixed model fit with total hip aBMD at 9 months as the outcome. Treatment, participant sex and menopausal status will be considered in analysis. Groups will be compared using contrast statements at 9 months, with change over 9 months being the primary comparison.
ETHICS AND DISSEMINATION


This study was approved by the Institutional Review Board of the University of Nebraska Medical Center (IRB820-19). Written consent will be obtained from participants at enrolment by trained staff. Careful and thorough explanation are used in obtainment of consent and voluntariness is emphasised throughout the trial. The findings of this study will be presented locally, nationally, and published in peer-reviewed journals. Additional details will be reported on ClinicalTrials.gov.
TRIAL REGISTRATION NUMBER


NCT04279392.",2021,"Secondary outcomes include change in aBMD of the femoral neck, and lumbar spine, and change in volumetric BMD at the lumbar spine.","['patients with osteoporosis', '30 adult SG patients', 'sleeve gastrectomy surgery']","['placebo', 'zoledronic acid', 'Sleeve gastrectomy (SG', 'Bisphosphonate medications', 'zoledronic acid or placebo']","['areal bone mineral density (aBMD) at the total hip', 'serum calcium and vitamin D levels', 'bone loss', 'change in aBMD of the femoral neck, and lumbar spine, and change in volumetric BMD at the lumbar spine']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}]",30.0,0.175465,"Secondary outcomes include change in aBMD of the femoral neck, and lumbar spine, and change in volumetric BMD at the lumbar spine.","[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Flores', 'Affiliation': 'College of Allied Health Professions, University of Nebraska Medical Center, Omaha, Nebraska, USA laura.flores@unmc.edu.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Mack', 'Affiliation': 'Diabetes, Endocrinology, & Metabolism, University of Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wichman', 'Affiliation': 'Department of Biostatistics, University of Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Weaver', 'Affiliation': 'Department of Biomedical Engineering, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Kothari', 'Affiliation': 'Department of Minimally Invasive Surgery, University of Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Bilek', 'Affiliation': 'College of Allied Health Professions, University of Nebraska Medical Center, Omaha, Nebraska, USA.'}]",BMJ open,['10.1136/bmjopen-2021-057483']
1504,34887283,Process evaluation protocol of a cluster randomised trial for a scalable solution for delivery of Diabetes Self-Management Education in Thailand (DSME-T).,"INTRODUCTION


Type 2 diabetes mellitus is a major global challenge, including for Thai policy-makers, as an estimated 4 million people in Thailand (population 68 million) have this condition. Premature death and disability due to diabetes are primarily due to complications which can be prevented by good risk factor control. Diabetes Self-Management Education (DSME) programmes provide patients with diabetes with the necessary knowledge and skills to effectively manage their disease. Currently, a trial is being conducted in Thailand to evaluate the effectiveness, defined as HbA1c<7 at 12 months after enrolment, of a culturally tailored DSME in Thailand. A process evaluation can provide further interpretation of the results from complex interventions as well as insight into the success of applying the programme into a broader context.
METHODS AND ANALYSIS


The aim of the process evaluation is to understand how and why the intervention was effective or ineffective and to identify contextually relevant strategies for future successful implementation. For the process evaluation, the design will be a mixed-method study collecting data from nurse providers, and village health volunteers (community health workers) as well as patients. This will be conducted using observations, interviews and focus groups from the three purposively selected groups at the beginning and end of trial. Quantitative data will be collected through surveys conducted at the beginning, during 6-month follow-up, and at the end of trial. The mixed-methods analysis will be triangulated to assess differences and similarities across the various data sources. The overall effectiveness of the intervention will be examined using multilevel analysis of repeated measures.
ETHICS AND DISSEMINATION


Study approved by the Chiang Mai University Research Ethics Committee (326/2018) and the London School of Hygiene & Tropical Medicine (16113/RR/12850). Results will be published in open access, peer-reviewed scientific journals.
TRIAL REGISTRATION NUMBER


NCT03938233.",2021,"A process evaluation can provide further interpretation of the results from complex interventions as well as insight into the success of applying the programme into a broader context.
","['Diabetes Self-Management Education in Thailand (DSME-T', 'village health volunteers (community health workers', 'patients with diabetes']",['DSME'],[],"[{'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],,0.0343069,"A process evaluation can provide further interpretation of the results from complex interventions as well as insight into the success of applying the programme into a broader context.
","[{'ForeName': 'Iliatha', 'Initials': 'I', 'LastName': 'Papachristou Nadal', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Chanchanok', 'Initials': 'C', 'LastName': 'Aramrat', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Wichuda', 'Initials': 'W', 'LastName': 'Jiraporncharoen', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kanokporn', 'Initials': 'K', 'LastName': 'Pinyopornpanish', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Nutchar', 'Initials': 'N', 'LastName': 'Wiwatkunupakarn', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Orawan', 'Initials': 'O', 'LastName': 'Quansri', 'Affiliation': 'ASEAN Health Institute for Health Development, Mahidol University, Salaya, Nakhon Pathom, Thailand.'}, {'ForeName': 'Kittipan', 'Initials': 'K', 'LastName': 'Rerkasem', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Supattra', 'Initials': 'S', 'LastName': 'Srivanichakorn', 'Affiliation': 'Department of Disease Control, Ministry of Public Health, Bangkok, Nonthaburi, Thailand.'}, {'ForeName': 'Win', 'Initials': 'W', 'LastName': 'Techakehakij', 'Affiliation': 'Lampang Hospital, Lampang, Thailand.'}, {'ForeName': 'Nutchanath', 'Initials': 'N', 'LastName': 'Wichit', 'Affiliation': 'Surat Thani Rajabhat University, Surat Thani, Thailand.'}, {'ForeName': 'Chanapat', 'Initials': 'C', 'LastName': 'Pateekhum', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Birk', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Elisha', 'Initials': 'E', 'LastName': 'Ngetich', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Hanson', 'Affiliation': 'Department of Global Health and Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kinra', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Chaisiri', 'Initials': 'C', 'LastName': 'Angkurawaranon', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand chaisiri.a@cmu.ac.th.'}]",BMJ open,['10.1136/bmjopen-2021-056141']
1505,34924372,Probiotic Releasing Angiotensin (1-7) in a Drosophila Model of Alzheimer's Disease Produces Sex-Specific Effects on Cognitive Function.,"BACKGROUND


While extensive research on the brain has failed to identify effective therapies, using probiotics to target the gut microbiome has shown therapeutic potential in Alzheimer's disease (AD). Genetically modified probiotics (GMP) are a promising strategy to deliver key therapeutic peptides with high efficacy and tissue specificity. Angiotensin (Ang)-(1-7) levels inversely correlate to AD severity, but its administration is challenging. Our group has successfully established a GMP-based method of Ang-(1-7) delivery.
OBJECTIVE


Since Drosophila represents an excellent model to study the effect of probiotics on complex disorders in a high throughput manner, we tested whether oral supplementation with Lactobacillus paracasei releasing Ang-(1-7) (LP-A) delays memory loss in a Drosophila AD model.
METHODS


Flies overexpressing the human amyloid-β protein precursor and its β-site cleaving enzyme in neurons were randomized to receive four 24-h doses of Lactobacillus paracasei alone (LP), LP-A or sucrose over 14 days. Memory was assessed via an aversive phototaxic suppression assay.
RESULTS


Optimal dilution,1:2, was determined based on palatability. LP-A improved memory in trained AD males but worsened cognition in AD females. LP-supplementation experiments confirmed that Ang-(1-7) conferred additional cognitive benefits in males and was responsible for the deleterious cognitive effects in females. Sex-specific differences in the levels of angiotensin peptides and differential activation of the kynurenine pathway of tryptophan metabolism in response to supplementation may underlie this male-only therapeutic response.
CONCLUSION


In summary, LP-A ameliorated the memory deficits of a Drosophila AD model, but effects were sex-specific. Dosage optimization may be required to address this differential response.",2022,"In summary, LP-A ameliorated the memory deficits of a Drosophila AD model, but effects were sex-specific.",['Flies overexpressing the human amyloid-β protein precursor and its β-site cleaving enzyme in neurons'],"['Genetically modified probiotics (GMP', 'Probiotic Releasing Angiotensin', 'Lactobacillus paracasei alone (LP), LP-A or sucrose']","['additional cognitive benefits', 'LP-A improved memory']","[{'cui': 'C0012578', 'cui_str': 'Order Diptera'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0033665', 'cui_str': 'Protein Precursors'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0027882', 'cui_str': 'Neuron'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0051844', 'cui_str': 'Angiogenin'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]","[{'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0051844', 'cui_str': 'Angiogenin'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.0412949,"In summary, LP-A ameliorated the memory deficits of a Drosophila AD model, but effects were sex-specific.","[{'ForeName': 'C Aaron', 'Initials': 'CA', 'LastName': 'Smith', 'Affiliation': 'McWhorter School of Pharmacy, Samford University, Birmingham, AL, USA.'}, {'ForeName': 'Haddon', 'Initials': 'H', 'LastName': 'Smith', 'Affiliation': 'McWhorter School of Pharmacy, Samford University, Birmingham, AL, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': 'Department of Medicine; Division of Gerontology, Geriatrics, and Palliative Care, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Coward', 'Affiliation': 'Pharmaceutical Sciences Research Institute, Samford University, Birmingham, AL, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Gorman', 'Affiliation': 'McWhorter School of Pharmacy, Samford University, Birmingham, AL, USA.'}, {'ForeName': 'Amrisha', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Department of Ophthalmology, College of Medicine, University of Florida Gainesville, FL, USA.'}, {'ForeName': 'Qiuhong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, College of Medicine, University of Florida Gainesville, FL, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Buford', 'Affiliation': 'Department of Medicine; Division of Gerontology, Geriatrics, and Palliative Care, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Christy S', 'Initials': 'CS', 'LastName': 'Carter', 'Affiliation': 'Department of Medicine; Division of Gerontology, Geriatrics, and Palliative Care, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Jumbo-Lucioni', 'Affiliation': 'McWhorter School of Pharmacy, Samford University, Birmingham, AL, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-210464']
1506,34931602,Lamotrigine versus levetiracetam or zonisamide for focal epilepsy and valproate versus levetiracetam for generalised and unclassified epilepsy: two SANAD II non-inferiority RCTs.,"BACKGROUND


Levetiracetam (Keppra ® , UCB Pharma Ltd, Slough, UK) and zonisamide (Zonegran ® , Eisai Co. Ltd, Tokyo, Japan) are licensed as monotherapy for focal epilepsy, and levetiracetam is increasingly used as a first-line treatment for generalised epilepsy, particularly for women of childbearing age. However, there is uncertainty as to whether or not they should be recommended as first-line treatments owing to a lack of evidence of clinical effectiveness and cost-effectiveness.
OBJECTIVES


To compare the clinical effectiveness and cost-effectiveness of lamotrigine (Lamictal ® , GlaxoSmithKline plc, Brentford, UK) (standard treatment) with levetiracetam and zonisamide (new treatments) for focal epilepsy, and to compare valproate (Epilim ® , Sanofi SA, Paris, France) (standard treatment) with levetiracetam (new treatment) for generalised and unclassified epilepsy.
DESIGN


Two pragmatic randomised unblinded non-inferiority trials run in parallel.
SETTING


Outpatient services in NHS hospitals throughout the UK.
PARTICIPANTS


Those aged ≥ 5 years with two or more spontaneous seizures that require anti-seizure medication.
INTERVENTIONS


Participants with focal epilepsy were randomised to receive lamotrigine, levetiracetam or zonisamide. Participants with generalised or unclassifiable epilepsy were randomised to receive valproate or levetiracetam. The randomisation method was minimisation using a web-based program.
MAIN OUTCOME MEASURES


The primary outcome was time to 12-month remission from seizures. For this outcome, and all other time-to-event outcomes, we report hazard ratios for the standard treatment compared with the new treatment. For the focal epilepsy trial, the non-inferiority limit (lamotrigine vs. new treatments) was 1.329. For the generalised and unclassified epilepsy trial, the non-inferiority limit (valproate vs. new treatments) was 1.314. Secondary outcomes included time to treatment failure, time to first seizure, time to 24-month remission, adverse reactions, quality of life and cost-effectiveness.
RESULTS


Focal epilepsy . A total of 990 participants were recruited, of whom 330 were randomised to receive lamotrigine, 332 were randomised to receive levetiracetam and 328 were randomised to receive zonisamide. Levetiracetam did not meet the criteria for non-inferiority (hazard ratio 1.329) in the primary intention-to-treat analysis of time to 12-month remission (hazard ratio vs. lamotrigine 1.18, 97.5% confidence interval 0.95 to 1.47), but zonisamide did meet the criteria (hazard ratio vs. lamotrigine 1.03, 97.5% confidence interval 0.83 to 1.28). In the per-protocol analysis, lamotrigine was superior to both levetiracetam (hazard ratio 1.32, 95% confidence interval 1.05 to 1.66) and zonisamide (hazard ratio 1.37, 95% confidence interval 1.08 to 1.73). For time to treatment failure, lamotrigine was superior to levetiracetam (hazard ratio 0.60, 95% confidence interval 0.46 to 0.77) and zonisamide (hazard ratio 0.46, 95% confidence interval 0.36 to 0.60). Adverse reactions were reported by 33% of participants starting lamotrigine, 44% starting levetiracetam and 45% starting zonisamide. In the economic analysis, both levetiracetam and zonisamide were more costly and less effective than lamotrigine and were therefore dominated.  Generalised and unclassifiable epilepsy . Of 520 patients recruited, 260 were randomised to receive valproate and 260 were randomised to receive to levetiracetam. A total of 397 patients had generalised epilepsy and 123 had unclassified epilepsy. Levetiracetam did not meet the criteria for non-inferiority in the primary intention-to-treat analysis of time to 12-month remission (hazard ratio 1.19, 95% confidence interval 0.96 to 1.47; non-inferiority margin 1.314). In the per-protocol analysis of time to 12-month remission, valproate was superior to levetiracetam (hazard ratio 1.68, 95% confidence interval 1.30 to 2.15). Valproate was superior to levetiracetam for time to treatment failure (hazard ratio 0.65, 95% confidence interval 0.50 to 0.83). Adverse reactions were reported by 37.4% of participants receiving valproate and 41.5% of those receiving levetiracetam. Levetiracetam was both more costly (incremental cost of £104, 95% central range -£587 to £1234) and less effective (incremental quality-adjusted life-year of -0.035, 95% central range -0.137 to 0.032) than valproate, and was therefore dominated. At a cost-effectiveness threshold of £20,000 per quality-adjusted life-year, levetiracetam was associated with a probability of 0.17 of being cost-effective.
LIMITATIONS


The SANAD II trial was unblinded, which could have biased results by influencing decisions about dosing, treatment failure and the attribution of adverse reactions.
FUTURE WORK


SANAD II data could now be included in an individual participant meta-analysis of similar trials, and future similar trials are required to assess the clinical effectiveness and cost-effectiveness of other new treatments, including lacosamide and perampanel.
CONCLUSIONS


Focal epilepsy  - The SANAD II findings do not support the use of levetiracetam or zonisamide as first-line treatments in focal epilepsy.  Generalised and unclassifiable epilepsy  - The SANAD II findings do not support the use of levetiracetam as a first-line treatment for newly diagnosed generalised epilepsy. For women of childbearing potential, these results inform discussions about the benefit (lower teratogenicity) and harm (worse seizure outcomes and higher treatment failure rate) of levetiracetam compared with valproate.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN30294119 and EudraCT 2012-001884-64.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 25, No. 75. See the NIHR Journals Library website for further project information.",2021,"Levetiracetam was both more costly (incremental cost of £104, 95% central range -£587 to £1234) and less effective (incremental quality-adjusted life-year of -0.035, 95% central range -0.137 to 0.032) than valproate, and was therefore dominated.","['520 patients recruited, 260 were randomised to receive', 'Participants with focal epilepsy', 'newly diagnosed generalised epilepsy', 'A total of 990 participants were recruited, of whom 330 were randomised to receive', 'Participants with generalised or unclassifiable epilepsy', 'EudraCT 2012-001884-64', '397 patients had generalised epilepsy and 123 had unclassified epilepsy', 'Outpatient services in NHS hospitals throughout the UK', 'women of childbearing age', 'Those aged ≥\u20095 years with two or more spontaneous seizures that require anti-seizure medication']","['valproate versus levetiracetam', 'levetiracetam or zonisamide', 'zonisamide', 'lamotrigine, levetiracetam or zonisamide', 'Levetiracetam', 'valproate', 'lamotrigine (Lamictal ® , GlaxoSmithKline plc, Brentford, UK) (standard treatment) with levetiracetam and zonisamide', 'Lamotrigine', 'levetiracetam and zonisamide', 'levetiracetam', 'valproate or levetiracetam', 'lamotrigine', 'Valproate']","['time to treatment failure, time to first seizure, time to 24-month remission, adverse reactions, quality of life and cost-effectiveness', 'clinical effectiveness and cost-effectiveness', 'time to 12-month remission from seizures', 'Adverse reactions']","[{'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517916', 'cui_str': '990'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205426', 'cui_str': 'Unclassified'}, {'cui': 'C0086751', 'cui_str': 'Outpatient service'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0078844', 'cui_str': 'zonisamide'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0678180', 'cui_str': 'Lamictal'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}]",990.0,0.821669,"Levetiracetam was both more costly (incremental cost of £104, 95% central range -£587 to £1234) and less effective (incremental quality-adjusted life-year of -0.035, 95% central range -0.137 to 0.032) than valproate, and was therefore dominated.","[{'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Marson', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Girvan', 'Initials': 'G', 'LastName': 'Burnside', 'Affiliation': 'Department of Health Data Science, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Appleton', 'Affiliation': ""The Roald Dahl EEG Unit, Alder Hey Children's Health Park, Liverpool, UK.""}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'John Paul', 'Initials': 'JP', 'LastName': 'Leach', 'Affiliation': 'School of Medicine, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Sills', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Tudur-Smith', 'Affiliation': 'Department of Health Data Science, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Catrin O', 'Initials': 'CO', 'LastName': 'Plumpton', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Dyfrig A', 'Initials': 'DA', 'LastName': 'Hughes', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Department of Health Data Science, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Baker', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Silviya', 'Initials': 'S', 'LastName': 'Balabanova', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': ""Addenbrooke's Hospital NHS Foundation Trust, Cambridge, UK.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Hindley', 'Affiliation': 'Bolton NHS Foundation Trust, Royal Bolton Hospital, Bolton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Howell', 'Affiliation': 'Department of Neurology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Maguire', 'Affiliation': 'School of Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Mohanraj', 'Affiliation': 'Salford Royal NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Philip Em', 'Initials': 'PE', 'LastName': 'Smith', 'Affiliation': 'The Alan Richens Epilepsy Unit, University Hospital of Wales, Cardiff, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta25750']
1507,34935127,Antenatal corticosteroids prior to planned caesarean at term for improving neonatal outcomes.,"BACKGROUND


Infants born at term by elective caesarean section are more likely to develop respiratory morbidity than infants born vaginally. Prophylactic corticosteroids in singleton preterm pregnancies accelerate lung maturation and reduce the incidence of respiratory complications. It is unclear whether administration at term gestations, prior to caesarean section, improves the respiratory outcomes for these babies without causing any unnecessary morbidity to the mother or the infant.
OBJECTIVES


The objective of this review was to assess the effect of prophylactic corticosteroid administration before elective caesarean section at term, as compared to usual care (which could be placebo or no treatment), on fetal, neonatal and maternal morbidity. We also assessed the impact of the treatment on the child in later life.
SEARCH METHODS


For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov (20 January 2021) and reference lists of retrieved studies.
SELECTION CRITERIA


We included randomised controlled trials comparing prophylactic antenatal corticosteroid administration (betamethasone or dexamethasone) with placebo or with no treatment, given before elective caesarean section at term (at or after 37 weeks of gestation). Quasi-randomised and cluster-randomised controlled trials were also eligible for inclusion.
DATA COLLECTION AND ANALYSIS


We used standard Cochrane Pregnancy and Childbirth methods for data collection and analysis. Two review authors independently assessed trials for inclusion, assessed risk of bias, evaluated trustworthiness (based on predefined criteria developed by Cochrane Pregnancy and Childbirth), extracted data and checked them for accuracy and assessed the certainty of the evidence using the GRADE approach. Our primary outcomes were respiratory distress syndrome (RDS), transient tachypnoea of the neonate (TTN), admission to neonatal special care for respiratory morbidity and need for mechanical ventilation. We planned to perform subgroup analyses for the primary outcomes according to gestational age at randomisation and type of corticosteroid (betamethasone or dexamethasone). We also planned to perform sensitivity analysis, including only studies at low risk of bias.
MAIN RESULTS


We included one trial in which participants were randomised to receive either betamethasone or usual care. The trial included 942 women and 942 neonates recruited from 10 UK hospitals between 1995 and 2002. This review includes only trials that met predefined criteria for trustworthiness. We removed three trials from the analysis that were included in the previous version of this review. The risk of bias was low for random sequence generation, allocation concealment and incomplete outcome data. The risk of bias for selective outcome reporting was unclear because there was no published trial protocol, and therefore it is unclear whether all the planned outcomes were reported in full. Due to a lack of blinding we judged there to be high risk of performance bias and detection bias. We downgraded the certainty of the evidence because of concerns about risk of bias and because of imprecision due to low event rates and wide 95% confidence intervals (CIs), which are consistent with possible benefit and possible harm Compared with usual care, it is uncertain if antenatal corticosteroids reduce the risk of RDS (relative risk (RR) 0.34 95% CI 0.07 to 1.65; 1 study; 942 infants) or TTN (RR 0.52, 95% CI 0.25 to 1.11; 1 study; 938 infants) because the certainty of evidence is low and the 95% CIs are consistent with possible benefit and possible harm. Antenatal corticosteroids probably reduce the risk of admission to neonatal special care for respiratory complications, compared with usual care (RR 0.45, 95% CI 0.22 to 0.90; 1 study; 942 infants; moderate-certainty evidence). The proportion of infants admitted to neonatal special care for respiratory morbidity after treatment with antenatal corticosteroids was 2.3% compared with 5.1% in the usual care group. It is uncertain if antenatal steroids have any effect on the risk of needing mechanical ventilation, compared with usual care (RR 4.07, 95% CI 0.46 to 36.27; 1 study; 942 infants; very low-certainty evidence). The effect of antenatal corticosteroids on the maternal development of postpartum infection/pyrexia in the first 72 hours is unclear due to the very low certainty of the evidence; one study (942 women) reported zero cases. The included studies did not report any data for neonatal hypoglycaemia or maternal mortality/severe mortality.
AUTHORS' CONCLUSIONS


Evidence from one randomised controlled trial suggests that prophylactic corticosteroids before elective caesarean section at term probably reduces admission to the neonatal intensive care unit for respiratory morbidity. It is uncertain if administration of antenatal corticosteroids reduces the rates of respiratory distress syndrome (RDS) or transient tachypnoea of the neonate (TTN). The overall certainty of the evidence for the primary outcomes was found to be low or very low, apart from the outcome of admission to neonatal special care (all levels) for respiratory morbidity, for which the evidence was of moderate certainty. Therefore, there is currently insufficient data to draw any firm conclusions.  More evidence is needed to investigate the effect of prophylactic antenatal corticosteroids on the incidence of recognised respiratory morbidity such as RDS. Any future trials should assess the balance between respiratory benefit and potential immediate adverse effects (e.g. hypoglycaemia) and long-term adverse effects (e.g. academic performance) for the infant. There is very limited information on maternal health outcomes to provide any assurances that corticosteroids do not pose any increased risk of harm to the mother.  Further research should consider investigating the effectiveness of antenatal steroids at different gestational ages prior to caesarean section. There are nine potentially eligible studies that are currently ongoing and could be included in future updates of this review.",2021,"Antenatal corticosteroids probably reduce the risk of admission to neonatal special care for respiratory complications, compared with usual care (RR 0.45, 95% CI 0.22 to 0.90; 1 study; 942 infants; moderate-certainty evidence).","['1 study; 938 infants', 'Infants born at term by elective caesarean section', 'singleton preterm pregnancies', '942 women and 942 neonates recruited from 10 UK hospitals between 1995 and 2002']","['corticosteroid (betamethasone or dexamethasone', 'prophylactic antenatal corticosteroid administration (betamethasone or dexamethasone', 'Prophylactic corticosteroids', 'antenatal corticosteroids', 'placebo or with no treatment, given before elective caesarean section', 'Antenatal corticosteroids', 'prophylactic corticosteroids', 'prophylactic corticosteroid', 'betamethasone or usual care']","['neonatal outcomes', 'neonatal hypoglycaemia or maternal mortality/severe mortality', 'rates of respiratory distress syndrome (RDS', 'risk of admission to neonatal special care for respiratory complications', 'maternal development of postpartum infection/pyrexia', 'respiratory morbidity', 'incidence of respiratory complications', 'respiratory distress syndrome (RDS), transient tachypnoea of the neonate (TTN), admission to neonatal special care for respiratory morbidity and need for mechanical ventilation']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0158986', 'cui_str': 'Neonatal hypoglycemia'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",942.0,0.443555,"Antenatal corticosteroids probably reduce the risk of admission to neonatal special care for respiratory complications, compared with usual care (RR 0.45, 95% CI 0.22 to 0.90; 1 study; 942 infants; moderate-certainty evidence).","[{'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Sotiriadis', 'Affiliation': 'Second Department of Obstetrics and Gynaecology, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McGoldrick', 'Affiliation': ""Obstetrics Directorate, Liverpool Women's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Makrydimas', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Papatheodorou', 'Affiliation': 'Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'John Pa', 'Initials': 'JP', 'LastName': 'Ioannidis', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine and Department of Health Research and Policy, Palo Alto, California, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Stewart', 'Affiliation': 'c/o Cochrane Incontinence, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Roses', 'Initials': 'R', 'LastName': 'Parker', 'Affiliation': 'Cochrane MOSS Network, c/o Cochrane Pain Palliative and Supportive Care Group, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD006614.pub4']
1508,34935913,The effect of Covid-19 mRNA vaccine on serum anti-Müllerian hormone levels.,"STUDY QUESTION


Does the administration of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccine have an association with ovarian reserve as expressed by circulating anti-Müllerian hormone (AMH) levels?
SUMMARY ANSWER


Ovarian reserve as assessed by serum AMH levels is not altered at 3 months following mRNA SARS-CoV-2 vaccination.
WHAT IS KNOWN ALREADY


A possible impact of SARS-CoV-2 infection or vaccination through an interaction between the oocyte and the somatic cells could not be ruled out, however, data are limited.
STUDY DESIGN, SIZE, DURATION


This is a prospective study conducted at a university affiliated tertiary medical center between February and March 2021.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Study population included reproductive aged women (18-42 years) that were vaccinated by two Pfizer-BioNTech Covid-19 vaccines (21 days apart). Women with ovarian failure, under fertility treatments, during pregnancy, previous Covid-19 infection or vaccinated were excluded from the study. Blood samples were collected for AMH levels before the first mRNA vaccine administration. Additional blood samples after 3 months were collected for AMH and anti-Covid-19 antibody levels. Primary outcome was defined as the absolute and percentage change in AMH levels.
MAIN RESULTS AND THE ROLE OF CHANCE


The study group consisted of 129 women who received two mRNA vaccinations. Mean AMH levels were 5.3 (±SD 4.29) µg/l and 5.3 (±SD 4.50) µg/l at baseline and after 3 months, respectively (P = 0.11). To account for possible age-specific changes of AMH, sub-analyses were performed for three age groups: <30, 30-35 and >35 years. AMH levels were significantly lower for women older than 35 years at all times (P = 0.001 for pre and post vaccination AMH levels versus younger women). However, no significant differences for the changes in AMH levels before and after vaccinations (Delta AMH) were observed for the three age groups (P = 0.46). Additionally, after controlling for age, no association was found between the degree of immunity response and AMH levels.
LIMITATIONS, REASONS FOR CAUTION


Although it was prospectively designed, for ethical reasons we could not assign a priori a randomized unvaccinated control group. This study examined plasma AMH levels at 3 months after the first vaccination. It could be argued that possible deleterious ovarian and AMH changes caused by the SARS-CoV-2 mRNA vaccinations might take effect only at a later time. Only longer-term studies will be able to examine this issue.
WIDER IMPLICATIONS OF THE FINDINGS


The results of the study provide reassurance for women hesitant to complete vaccination against Covid 19 due to concerns regarding its effect on future fertility. This information could be of significant value to physicians and patients alike.
STUDY FUNDING/COMPETING INTEREST(S)


The study was supported by Sheba Medical Center institutional sources. All authors have nothing to disclose.
TRIAL REGISTRATION NUMBER


The study protocol was approved by the 'Sheba Medical Center' Ethical Committee Review Board (ID 8121-21-SMC) on 8 February 2021 and was registered at the National Institutes of Health (NCT04748172).",2022,AMH levels were significantly lower for women older than 35 years at all times (p = 0.001 for pre and post vaccination AMH levels versus younger women).,"['university affiliated tertiary medical center between February to March 2021', 'Women with ovarian failure, under fertility treatments, during pregnancy, previous Covid-19 infection or vaccinated were excluded from the study', '129 women who received two mRNA vaccinations', 'Study population included reproductive aged women (18-42\u2009years']",['Covid-19 mRNA vaccine'],"['plasma AMH levels', 'absolute and percentage change in AMH levels', 'serum AMH levels', 'Mean AMH levels', 'AMH levels', 'serum anti-Müllerian hormone levels', 'degree of immunity response and AMH levels']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0747102', 'cui_str': 'Ovarian failure'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}]",129.0,0.167953,AMH levels were significantly lower for women older than 35 years at all times (p = 0.001 for pre and post vaccination AMH levels versus younger women).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mohr-Sasson', 'Affiliation': 'Department of Obstetrics and Gynecology, Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Haas', 'Affiliation': 'Department of Obstetrics and Gynecology, Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Abuhasira', 'Affiliation': 'Department of Obstetrics and Gynecology, Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sivan', 'Affiliation': 'Department of Obstetrics and Gynecology, Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Doitch Amdurski', 'Affiliation': 'Department of Obstetrics and Gynecology, Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Dadon', 'Affiliation': 'Department of Obstetrics and Gynecology, Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Blumenfeld', 'Affiliation': 'Department of Obstetrics and Gynecology, Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Derazne', 'Affiliation': 'Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hemi', 'Affiliation': 'Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Orvieto', 'Affiliation': 'Department of Obstetrics and Gynecology, Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Afek', 'Affiliation': 'Department of Obstetrics and Gynecology, Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rabinovici', 'Affiliation': 'Department of Obstetrics and Gynecology, Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deab282']
1509,34936167,"Sex differences in acute cannabis effects revisited: Results from two randomized, controlled trials.","Some evidence suggests that males and females may differ in their responses to acute cannabis effects, including subjective drug effects and behavioural effects, and cannabinoid pharmacokinetics. This is significant given current changes to cannabis-related policies and, in consequence, increased cannabis accessibility. The present study combines data from two randomized controlled trials to investigate possible differences among males (n = 21) and females (n = 19) in the acute effects of vaporized cannabis containing 13.75 mg Δ9-tetrahydrocannabinol (THC), with and without cannabidiol (CBD; 13.75 mg). To control for differences in the timing of assessments, peak (or peak change from baseline) scores were calculated for a range of measures including subjective drug effects, cognitive performance, cardiovascular effects, and plasma concentrations of THC, CBD, and their respective primary metabolites. While THC elicited robust and significant changes in all but one outcome measure relative to placebo, relatively few sex differences were observed after controlling for BMI and plasma THC concentrations. Relative to females, males performed better overall on a divided attention task (DAT) and had higher peak plasma concentrations of 11-nor-9-carboxy-THC (11-COOH-THC). Males and females did not differ with respect to plasma concentrations of any other analyte, subjective drug effects, or cardiovascular measures. These data indicate an absence of systematic sex differences in acute cannabis effects given a moderate dose of vaporized cannabis. They do not preclude the possibility that sex differences may emerge with higher THC doses or with other commonly used routes of administration (e.g., orally administered oils or edibles).",2022,"Males and females did not differ with respect to plasma concentrations of any other analyte, subjective drug effects, or cardiovascular measures.",['males (n\u2009=\u200921) and females (n\u2009=\u200919) in the acute effects of'],"['vaporized cannabis containing 13.75\u2009mg Δ9-tetrahydrocannabinol (THC), with and without cannabidiol (CBD']","['peak plasma concentrations of 11-nor-9-carboxy-THC (11-COOH-THC', 'subjective drug effects, cognitive performance, cardiovascular effects, and plasma concentrations of THC, CBD, and their respective primary metabolites', 'BMI and plasma THC concentrations', 'divided attention task (DAT']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0368839', 'cui_str': 'Carboxy tetrahydrocannabinol'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0589101', 'cui_str': 'Divided attention'}]",,0.0520044,"Males and females did not differ with respect to plasma concentrations of any other analyte, subjective drug effects, or cardiovascular measures.","[{'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Arkell', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Kevin', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Vinckenbosch', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Faculty of Medicine and Health, Central Clinical School, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Eef', 'Initials': 'E', 'LastName': 'Theunissen', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Iain S', 'Initials': 'IS', 'LastName': 'McGregor', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, New South Wales, Australia.'}]",Addiction biology,['10.1111/adb.13125']
1510,34929355,Improving upper-limb and trunk kinematics by interactive gaming in individuals with chronic stroke: A single-blinded RCT.,"BACKGROUND


Commercial gaming systems are increasingly being used for stroke rehabilitation; however, their effect on upper-limb recovery versus compensation is unknown.
OBJECTIVES


We aimed to compare the effect of upper-limb rehabilitation using interactive gaming (Nintendo Wii) with dose-matched conventional therapy on elbow extension (recovery) and forward trunk motion (compensation) in individuals with chronic stroke. Secondary aims were to compare the effect on (1) clinical tests of impairment and activity, pain and effort, and (2) trajectory kinematics. We also explored arm and trunk motion (acceleration) during Wii sessions to understand how participants performed movements during Wii gaming.
METHODS


This single-centre, randomized controlled trial compared 12 hourly sessions over 4 weeks of upper-limb Wii therapy to conventional therapy. Outcomes were evaluated at baseline and 4 weeks. The change in elbow extension and trunk motion during a reaching task was evaluated by electromagnetic sensors. Secondary outcomes were change in Fugl-Meyer assessment, Box and Block test, Action Research Arm Test, Motor Activity Log, and Stroke Impact Scale scores. Arm and trunk acceleration during Wii therapy was evaluated by using inertial sensors. A healthy control group was included for reference data.
RESULTS


Nineteen participants completed Wii therapy and 21 conventional therapy (mean [SD] time post-stroke 66.4 [57.2] months). The intervention and control groups did not differ in mean change in elbow extension angle (Wii: +4.5°, 95% confidence interval [CI] 0.1; 9.1; conventional therapy: +6.4°, 95%CI 0.6; 12.2) and forward trunk position (Wii: -3.3 cm, 95%CI -6.2;-0.4]; conventional therapy: -4.1 cm, 95%CI -6.6; -1.6) (effect size: elbow, d = 0.16, p = 0.61; trunk, d = 0.13, p = 0.65). Clinical scores improved similarly but to a small extent in both groups. The amount of arm but not trunk acceleration produced during Wii sessions increased with training.
CONCLUSIONS


Supervised upper-limb gaming therapy induced similar recovery of elbow extension as conventional therapy and did not enhance the development of compensatory forward trunk movement in individuals with chronic stroke. More sessions may be necessary to induce greater improvements. CLINICALTRIALS.GOV: NCT01806883.",2022,Supervised upper-limb gaming therapy induced similar recovery of elbow extension as conventional therapy and did not enhance the development of compensatory forward trunk movement in individuals with chronic stroke.,"['individuals with chronic stroke', 'Nineteen participants completed']","['Wii therapy and 21 conventional therapy', 'Supervised upper-limb gaming therapy', 'upper-limb rehabilitation using interactive gaming (Nintendo Wii) with dose-matched conventional therapy', 'upper-limb Wii therapy to conventional therapy']","['change in Fugl-Meyer assessment, Box and Block test, Action Research Arm Test, Motor Activity Log, and Stroke Impact Scale scores', 'Clinical scores', 'elbow extension and trunk motion', 'mean change in elbow extension angle', 'elbow extension (recovery) and forward trunk motion (compensation', 'effect on 1) clinical tests of impairment and activity, pain and effort, and 2) trajectory kinematics']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",19.0,0.0711752,Supervised upper-limb gaming therapy induced similar recovery of elbow extension as conventional therapy and did not enhance the development of compensatory forward trunk movement in individuals with chronic stroke.,"[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Térémetz', 'Affiliation': 'Institute of Psychiatry and Neuroscience of Paris, INSERM U1266, Université de Paris, Paris, France.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, Garches, AP-HP. Université Paris Saclay, France; Team INSERM 1179, UFR de Santé Simone Veil, Université de Versailles Saint-Quentin, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Hanneton', 'Affiliation': 'Paris Institute of Sports and Health Science, URP 3625, UFR STAPS, Université de Paris, Paris, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Roby-Brami', 'Affiliation': 'Institute of Intelligent Systems and Robotics, Sorbonne University, CNRS UMR 7222, AGATHE team, INSERM U 1150, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Roche', 'Affiliation': 'Team INSERM 1179, UFR de Santé Simone Veil, Université de Versailles Saint-Quentin, France; Physiology and Functional Exploration Department, Raymond Poincaré Hospital, Garches, APHP. Université Paris-Saclay, France.'}, {'ForeName': 'Djamel', 'Initials': 'D', 'LastName': 'Bensmail', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, Garches, AP-HP. Université Paris Saclay, France; Team INSERM 1179, UFR de Santé Simone Veil, Université de Versailles Saint-Quentin, France.'}, {'ForeName': 'Påvel', 'Initials': 'P', 'LastName': 'Lindberg', 'Affiliation': 'Institute of Psychiatry and Neuroscience of Paris, INSERM U1266, Université de Paris, Paris, France.'}, {'ForeName': 'Johanna V G', 'Initials': 'JVG', 'LastName': 'Robertson', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, Garches, AP-HP. Université Paris Saclay, France; Team INSERM 1179, UFR de Santé Simone Veil, Université de Versailles Saint-Quentin, France. Electronic address: robertson.johanna@gmail.com.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2021.101622']
1511,34937718,Anaesthesia Choice for Creation of Arteriovenous Fistula (ACCess) study protocol : a randomised controlled trial comparing primary unassisted patency at 1 year of primary arteriovenous fistulae created under regional compared to local anaesthesia.,"INTRODUCTION


Arteriovenous fistulae (AVF) are the 'gold standard' vascular access for haemodialysis. Universal usage is limited, however, by a high early failure rate. Several small, single-centre studies have demonstrated better early patency rates for AVF created under regional anaesthesia (RA) compared with local anaesthesia (LA). The mechanistic hypothesis is that the sympathetic blockade associated with RA causes vasodilatation and increased blood flow through the new AVF. Despite this, considerable variation in practice exists in the UK. A high-quality, adequately powered, multicentre randomised controlled trial (RCT) is required to definitively inform practice.
METHODS AND ANALYSIS


The Anaesthesia Choice for Creation of Arteriovenous Fistula (ACCess) study is a multicentre, observer-blinded RCT comparing primary radiocephalic/brachiocephalic AVF created under regional versus LA. The primary outcome is primary unassisted AVF patency at 1 year. Access-specific (eg, stenosis/thrombosis), patient-specific (including health-related quality of life) and safety secondary outcomes will be evaluated. Health economic analysis will also be undertaken.
ETHICS AND DISSEMINATION


The ACCess study has been approved by the West of Scotland Research and ethics committee number 3 (20/WS/0178). Results will be published in open-access peer-reviewed journals within 12 months of completion of the trial. We will also present our findings at key national and international renal and anaesthetic meetings, and support dissemination of trial outcomes via renal patient groups.
TRIAL REGISTRATION NUMBER


ISRCTN14153938.
SPONSOR


NHS Greater Glasgow and Clyde GN19RE456, Protocol V.1.3 (8 May 2021), REC/IRAS ID: 290482.",2021,"Several small, single-centre studies have demonstrated better early patency rates for AVF created under regional anaesthesia (RA) compared with local anaesthesia (LA).",[],"['local anaesthesia', 'local anaesthesia (LA']","['blood flow', 'primary unassisted AVF patency at 1\u2009year', 'patency rates']",[],"[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.49708,"Several small, single-centre studies have demonstrated better early patency rates for AVF created under regional anaesthesia (RA) compared with local anaesthesia (LA).","[{'ForeName': 'Alan Jr', 'Initials': 'AJ', 'LastName': 'Macfarlane', 'Affiliation': 'Department of Anaesthesia, NHS Greater Glasgow and Clyde, Glasgow, UK alan.macfarlane@glasgow.ac.uk.'}, {'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Kearns', 'Affiliation': 'Department of Anaesthesia, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Marc James', 'Initials': 'MJ', 'LastName': 'Clancy', 'Affiliation': 'Department of Renal Surgery, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kingsmore', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Stevenson', 'Affiliation': 'Department of Renal Surgery, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jackson', 'Affiliation': 'Department of Renal Surgery, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mark', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Aitken', 'Affiliation': 'Department of Renal Surgery, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Ramani', 'Initials': 'R', 'LastName': 'Moonesinghe', 'Affiliation': 'Centre for Perioperative Medicine, University College London, London, UK.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Vindrola-Padros', 'Affiliation': 'Rapid Research Evaluation and Appraisal Lab, University College London, London, UK.'}, {'ForeName': 'Lucian', 'Initials': 'L', 'LastName': 'Gaianu', 'Affiliation': 'Independent Health Economist, Healthonomics UK Ltd, Reading, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Pettigrew', 'Affiliation': 'Department of Surgery, Cambridge University, Cambridge, UK.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Motallebzadeh', 'Affiliation': 'Department of Nephrology and Transplantation, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Karydis', 'Affiliation': ""Department of Transplantation, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Vesey', 'Affiliation': 'Department of Vascular Surgery, University Hospital Hairmyres, East Kilbride, UK.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesia, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Thalakunte', 'Initials': 'T', 'LastName': 'Muniraju', 'Affiliation': 'Department of Nephrology, Dumfries and Galloway Acute Hospitals, Dumfries, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Suttie', 'Affiliation': 'Department of Vascular Surgery, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Wetherall', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kariem', 'Initials': 'K', 'LastName': 'El-Boghdadly', 'Affiliation': ""Department of Anaesthesia and Perioperative Medicine, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Hogg', 'Affiliation': 'Department of Anaesthesia, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Thomson', 'Affiliation': 'Department of Anaesthesia, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Nangalia', 'Affiliation': 'Department of Anaesthesia, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Aitken', 'Affiliation': 'Department of Renal Surgery, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2021-052188']
1512,34937036,"Relationship between Depressive Symptoms and Cognitive, Psychological, and Physical Performance in Community-Dwelling Older People with Cognitive Impairment.","INTRODUCTION


Dementia and depression often coexist. Understanding how concomitant comorbidities affect function can improve assessment and management strategies. We examined the relationship between cognitive, psychological, and physical function and depressive symptoms in people with cognitive impairment.
METHODS


Cross-sectional study using baseline data from the iFOCIS randomized controlled trial involving 309 participants with mild-moderate cognitive impairment. The association between cognitive (Addenbrooke's Cognitive Examination-III [ACE-III], Frontal Assessment Battery), psychological (Goldberg Anxiety Scale; Iconographical Falls Efficacy Scale), and physical (Physiological Profile Assessment; Short Physical Performance Battery [SPPB]) function, and quality of life (QoL), physical activity levels and activities of daily living, and depressive symptoms (15-item Geriatric Depression Scale [GDS]) were assessed (adjusted for age, sex, education, and ACE-III as appropriate).
RESULTS


Participants with depressive symptoms (GDS ≥4) had significantly more falls in the previous year and a higher number of comorbidities than people without depressive symptoms (GDS <4). Each point increase in the GDS was associated with better memory, higher levels of anxiety and concern about falling, poorer balance, slower gait speed, and reduced QoL. The relationship between the GDS and poor balance and QoL withstood additional adjustment for comorbidity tertiles. The relationship between GDS and concern about falls withstood additional adjustment for previous falls (12 months) and SPPB scores.
CONCLUSIONS


Depressive symptomatology is associated with poorer physical and psychological function and reduced QoL in people with cognitive impairment. These factors should be considered when assessing and intervening in this group. Future research could examine these relationships longitudinally to establish causality and examine intervention efficacy in this group.",2021,"Each point increase in the GDS was associated with better memory, higher levels of anxiety and concern about falling, poorer balance, slower gait speed, and reduced QoL. The relationship between the GDS and poor balance and QoL withstood additional adjustment for comorbidity tertiles.","['people with cognitive impairment', '309 participants with mild-moderate cognitive impairment', 'Participants with depressive symptoms (GDS ≥4', 'Community-Dwelling Older People with Cognitive Impairment']",[],"['Depressive Symptoms and Cognitive, Psychological, and Physical Performance', 'cognitive, psychological, and physical function and depressive symptoms', 'levels of anxiety and concern about falling, poorer balance, slower gait speed', 'SPPB scores', ""cognitive (Addenbrooke's Cognitive Examination-III [ACE-III], Frontal Assessment Battery), psychological (Goldberg Anxiety Scale; Iconographical Falls Efficacy Scale), and physical (Physiological Profile Assessment; Short Physical Performance Battery [SPPB]) function, and quality of life (QoL), physical activity levels and activities of daily living, and depressive symptoms (15-item Geriatric Depression Scale [GDS"", 'Depressive symptomatology']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0234964', 'cui_str': 'Poor balance'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C2732353', 'cui_str': 'Frontal assessment battery'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}]",309.0,0.0347291,"Each point increase in the GDS was associated with better memory, higher levels of anxiety and concern about falling, poorer balance, slower gait speed, and reduced QoL. The relationship between the GDS and poor balance and QoL withstood additional adjustment for comorbidity tertiles.","[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Khoo', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, UNSW Sydney, Randwick, New South Wales, Australia.'}, {'ForeName': 'Jacqueline C T', 'Initials': 'JCT', 'LastName': 'Close', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, UNSW Sydney, Randwick, New South Wales, Australia.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Lord', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, UNSW Sydney, Randwick, New South Wales, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Delbaere', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, UNSW Sydney, Randwick, New South Wales, Australia.'}, {'ForeName': 'Morag E', 'Initials': 'ME', 'LastName': 'Taylor', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, UNSW Sydney, Randwick, New South Wales, Australia.'}]",Dementia and geriatric cognitive disorders,['10.1159/000520853']
1513,34940781,"Final Overall Survival and Molecular Analysis in IMmotion151, a Phase 3 Trial Comparing Atezolizumab Plus Bevacizumab vs Sunitinib in Patients With Previously Untreated Metastatic Renal Cell Carcinoma.","Importance


Interim analyses of the IMmotion151 trial (A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma) reported improved progression-free survival (PFS) for patients with programmed death ligand 1-positive (PD-L1+) metastatic renal cell carcinoma (mRCC) receiving the PD-L1 inhibitor atezolizumab plus the vascular endothelial growth factor (VEGF) inhibitor bevacizumab vs the receptor tyrosine kinase inhibitor sunitinib. Overall survival (OS) results were immature at interim analyses.
Objective


To report the final OS results, safety, and exploratory biomarker analyses of the association of transcriptomic subgroups with OS in the IMmotion151 trial.
Design, Setting, and Participants


IMmotion151 was a multicenter, open-label, phase 3 randomized clinical trial that compared the efficacy and safety of atezolizumab plus bevacizumab vs sunitinib in patients with untreated mRCC. IMmotion151 included patients from 152 academic medical centers and community oncology practices in 21 countries. Adult patients with mRCC with components of clear cell or sarcomatoid histologic features, measurable disease (according to Response Evaluation Criteria in Solid Tumors, version 1.1), adequate performance status, hematologic and end organ function, and tumor tissue available for PD-L1 testing were included. IMmotion151 was initiated on May 20, 2015, and the study is ongoing. This final analysis was performed from May 20, 2015, to February 14, 2020.
Interventions


Receipt of 1200 mg of intravenous (IV) atezolizumab every 3 weeks and 15 mg/kg of IV bevacizumab every 3 weeks or 50 mg orally once daily of sunitinib (4 weeks on and 2 weeks off).
Main Outcomes and Measures


The coprimary end points were PFS (previously reported) in patients with PD-L1+ disease and OS in the intention-to-treat population. Additional exploratory outcomes included OS in the PD-L1+ population, association with transcriptomic subgroups, and safety.
Results


The IMmotion151 trial assessed 915 patients with metastatic renal cell carcinoma. Mean (IQR) age was 62 (56-69) years for patients receiving atezolizumab plus bevacizumab and 60 (54-66) years for patients receiving sunitinib; 669 (73.1%) were male and 246 (26.9%) were female. The final analysis showed similar median OS in patients receiving atezolizumab plus bevacizumab vs sunitinib in the intention-to-treat (36.1 vs 35.3 months) and PD-L1+ (38.7 vs 31.6 months) populations. No new safety signals were reported. The additional exploratory outcome of atezolizumab plus bevacizumab vs sunitinib showed improved median OS trends in patients whose tumors were characterized by T-effector/proliferative, proliferative, or small nucleolar RNA transcriptomic profiles (35.4 vs 21.2 months; hazard ratio, 0.70; 95% CI, 0.50-0.98).
Conclusions and Relevance


The primary end point of PFS was met at interim analyses, although no improvement in OS was observed with atezolizumab plus bevacizumab at the final analysis. Biomarker analyses provided insight into which patients with mRCC may benefit from combined anti-PD-L1 and anti-VEGF therapy.
Trial Registration


ClinicalTrials.gov Identifier: NCT02420821.",2022,"The primary end point of PFS was met at interim analyses, although no improvement in OS was observed with atezolizumab plus bevacizumab at the final analysis.","['patients with untreated mRCC', 'Adult patients with mRCC with components of clear cell or sarcomatoid histologic features, measurable disease (according to Response Evaluation Criteria in Solid Tumors, version 1.1), adequate performance status, hematologic and end organ function, and tumor tissue available for PD-L1 testing were included', 'Participants With Untreated Advanced Renal Cell Carcinoma', '915 patients with metastatic renal cell carcinoma', 'patients with programmed death ligand 1-positive (PD-L1+) metastatic renal cell carcinoma (mRCC) receiving the', 'and 60 (54-66) years for patients receiving sunitinib; 669 (73.1%) were male and 246 (26.9%) were female', 'IMmotion151 included patients from 152 academic medical centers and community oncology practices in 21 countries', 'Patients With Previously Untreated Metastatic Renal Cell Carcinoma']","['Atezolizumab', 'atezolizumab plus bevacizumab vs sunitinib', 'PD-L1 inhibitor atezolizumab', 'bevacizumab', 'Atezolizumab Plus Bevacizumab', 'Bevacizumab Versus Sunitinib', 'intravenous (IV) atezolizumab', 'atezolizumab plus bevacizumab']","['progression-free survival (PFS', 'OS', 'efficacy and safety', 'OS in the PD-L1+ population, association with transcriptomic subgroups, and safety', 'median OS trends', 'median OS', 'Overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040833', 'cui_str': 'trends'}]",915.0,0.343138,"The primary end point of PFS was met at interim analyses, although no improvement in OS was observed with atezolizumab plus bevacizumab at the final analysis.","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute and the Royal Free Hospital, Queen Mary University of London, London, UK.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, DC.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron Institute of Oncology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.""}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Biologic Therapy and Cutaneous Oncology Programs, Hematology/Oncology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Boris Y', 'Initials': 'BY', 'LastName': 'Alekseev', 'Affiliation': 'P. Herzen Oncology Research Institute, Moscow, Russia.'}, {'ForeName': 'Jae-Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Suarez', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Daniil', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Moscow City Oncology Hospital, Moscow, Russia.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Mellado', 'Affiliation': ""Hospital Clínic of Barcelona, Medical Oncology Department, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Banchereau', 'Affiliation': 'Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Hamidi', 'Affiliation': 'Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Omara', 'Initials': 'O', 'LastName': 'Khan', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Craine', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Mahrukh', 'Initials': 'M', 'LastName': 'Huseni', 'Affiliation': 'Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Flinn', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Dubey', 'Affiliation': 'Genentech Inc, South San Francisco, California.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.'}]",JAMA oncology,['10.1001/jamaoncol.2021.5981']
1514,34942228,Impact of online Mindfulness-Based Cognitive Therapy on suicidal ideation: A secondary analysis of a randomized trial of Mindful Mood Balance.,"BACKGROUND


To address the elevated prevalence of depression, suicide, and suicidal ideation, patients require increased access to effective interventions. Mindfulness-Based Cognitive Therapy has a strong evidence base in relapse prophylaxis and can be delivered digitally through Mindful Mood Balance (MMB).
METHODS


This study was a secondary analysis of the impact of MMB paired with usual depression care (UDC) compared to UDC alone on patients in a randomized clinical trial for residual depression (Segal et al., 2020) who had a history of attempted suicide or reported current suicidal ideation (N = 109).
RESULTS


MMB relative to UDC was associated with a greater rate of reduction in suicidal ideation (SI; t(103) = 2.50, p = 0.014, d = 0.49, 95% CI [0.09-0.88]) and a greater likelihood of being in a lower severity category of SI (t(103) = 2.02, p = 0.046, odds ratio = 3.43, 95% CI [1.02-11.53]). There was also evidence that MMB reduces depression severity outcomes among this at risk group (t(105) = 2.38, p < 0.02, d = 0.46, 95% CI [0.07-0.85]).
LIMITATIONS


Reported findings are based on a subgroup of patients in a clinical trial originally designed to treat residual depressive symptoms.
CONCLUSIONS


Online interventions, such as MMB, may offer one solution to the challenge of expanding the reach of services for patients with residual depression who are at risk of suicidal ideation and behavior.",2022,"RESULTS


MMB relative to UDC was associated with a greater rate of reduction in suicidal ideation (SI; t(103) = 2.50, p = 0.014, d = 0.49, 95% CI [0.09-0.88]) and a greater likelihood of being in a lower severity category of SI (t(103) = 2.02, p = 0.046, odds ratio = 3.43, 95% CI [1.02-11.53]).","['patients with residual depression who are at risk of suicidal ideation and behavior', 'patients in a randomized clinical trial for residual depression (Segal et\xa0al., 2020) who had a history of attempted suicide or reported current suicidal ideation (N\xa0=\xa0109']","['MMB', 'UDC alone', 'Mindfulness-Based Cognitive Therapy', 'online Mindfulness-Based Cognitive Therapy', 'MMB paired with usual depression care (UDC']",['suicidal ideation'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0455507', 'cui_str': 'H/O: attempted suicide'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",,0.303464,"RESULTS


MMB relative to UDC was associated with a greater rate of reduction in suicidal ideation (SI; t(103) = 2.50, p = 0.014, d = 0.49, 95% CI [0.09-0.88]) and a greater likelihood of being in a lower severity category of SI (t(103) = 2.02, p = 0.046, odds ratio = 3.43, 95% CI [1.02-11.53]).","[{'ForeName': 'Sona', 'Initials': 'S', 'LastName': 'Dimidjian', 'Affiliation': 'University of Colorado Boulder, United States. Electronic address: sona.dimidjian@colorado.edu.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kaufman', 'Affiliation': 'University of Colorado Boulder, United States.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Coleman', 'Affiliation': 'University of Colorado Boulder, United States.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Levy', 'Affiliation': 'University of Colorado Boulder, United States.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Beck', 'Affiliation': 'Kaiser Permanente Colorado - Institute for Health Research, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gallop', 'Affiliation': 'West Chester University, United States.'}, {'ForeName': 'Zindel V', 'Initials': 'ZV', 'LastName': 'Segal', 'Affiliation': 'University of Toronto Scarborough, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2021.12.051']
1515,34942227,Dorsomedial prefrontal rTMS for depression in borderline personality disorder: A pilot randomized crossover trial.,"BACKGROUND


Recently, a small literature has emerged suggesting that repetitive transcranial magnetic stimulation (rTMS) may offer benefit for MDD even in BPD patients, perhaps by enhancing cognitive control, and/or disrupting excessive 'non-reward' activity in right orbitofrontal regions. This study aimed primarily to assess the therapeutic effects of dorsomedial prefrontal cortex (DMPFC)-rTMS against MDD symptoms in BPD patients, and secondarily to assess whether the therapeutic effects ensued via mechanisms of reduced impulsivity and core BPD pathology on clinical scales (BIS-11, ZAN-BPD) or of reduced alpha- and theta-band activity on EEG recordings of right orbitofrontal cortex..
METHODS


In a crossover-design trial, 20 BPD patients with MDD underwent 2 × 30 session/15 day blocks of either active-then-sham or sham-then-active bilateral 20 Hz DMPFC-rTMS.
RESULTS


Sixteen out of 20 patients completed treatment. A significant (p = 0.00764) crossover effect was detected, with overall reductions in HamD17 score from 23.1±SD3.1 to 10.75±SD5.8. Nine out of 16 (56.3%) treatment completers achieved response (>50% improvement) and 6/16 (37.5%) achieved remission (HamD≤7), maintained at 1 month followup. BIS-11 scores remained unchanged, and ZAN-BPD scores improved similarly in both groups with no significant crossover effect. Change in low-band power over right orbitofrontal regions correlated with clinical improvement.
LIMITATIONS


This was a crossover study with a small sample size. A randomized controlled trial with larger sample size will be needed to establish the efficacy more definitively.
CONCLUSIONS


The results suggest efficacy for DMPFC-rTMS in treating MDD in BPD, and provide a foundation for a larger future trial.",2022,"A significant (p = 0.00764) crossover effect was detected, with overall reductions in HamD17 score from 23.1±SD3.1 to 10.75±SD5.8.","['20 patients completed treatment', 'Sixteen', 'BPD patients', '20 BPD patients with MDD underwent 2', 'borderline personality disorder']","['dorsomedial prefrontal cortex (DMPFC)-rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'active-then-sham or sham-then-active bilateral 20\xa0Hz DMPFC-rTMS', 'DMPFC-rTMS']","['BIS-11 scores', 'ZAN-BPD scores', 'HamD17 score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}]","[{'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}]",20.0,0.0721008,"A significant (p = 0.00764) crossover effect was detected, with overall reductions in HamD17 score from 23.1±SD3.1 to 10.75±SD5.8.","[{'ForeName': 'Kfir', 'Initials': 'K', 'LastName': 'Feffer', 'Affiliation': 'Lev-Hasharon Mental Health Center, Tzur-Moshe, Sackler faculty of medicine, Tel-Aviv University, Israel.'}, {'ForeName': 'Hyewon Helen', 'Initials': 'HH', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, University of Toronto, Canada.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences and Wu Tsai Neuroscience Institute, Stanford University, Stanford, CA 94305, United States; Veterans Affairs Palo Alto Healthcare System, and the Sierra Pacific Mental Illness, Research, Education, and Clinical Center (MIRECC), Palo Alto, CA, 94394, United States.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences and Wu Tsai Neuroscience Institute, Stanford University, Stanford, CA 94305, United States; Veterans Affairs Palo Alto Healthcare System, and the Sierra Pacific Mental Illness, Research, Education, and Clinical Center (MIRECC), Palo Alto, CA, 94394, United States.'}, {'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Demchenko', 'Affiliation': 'University of Toronto, Faculty of Arts and Science, Canada.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Cairo', 'Affiliation': 'Krembil Research Institute, University Health Network, Canada; Centre for Mental Health, University Health Network, Toronto, Canada.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Mazza', 'Affiliation': 'University of Toronto, Faculty of Arts and Science, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fettes', 'Affiliation': 'University of Toronto, Faculty of Arts and Science, Canada.'}, {'ForeName': 'Farrokh', 'Initials': 'F', 'LastName': 'Mansouri', 'Affiliation': 'Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Kamaldeep', 'Initials': 'K', 'LastName': 'Bhui', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts & The London School of Medicine and Dentistry, Queen Mary University of London, United States.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Department of Psychiatry, University of Toronto, Canada; Campbell Family Mental Health Research Institute and Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Canada; Institute of Medical Science, University of Toronto, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Department of Psychiatry, University of Toronto, Canada; Campbell Family Mental Health Research Institute and Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Canada; Institute of Medical Science, University of Toronto, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Giacobbe', 'Affiliation': 'Department of Psychiatry, University of Toronto, Canada; Institute of Medical Science, University of Toronto, Canada; Harquail Centre for Neuromodulation, Sunnybrook Health Sciences Centre, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Department of Psychiatry, University of Toronto, Canada; Krembil Research Institute, University Health Network, Canada; Centre for Mental Health, University Health Network, Toronto, Canada; Institute of Medical Science, University of Toronto, Canada. Electronic address: jonathan.downar@utoronto.ca.'}]",Journal of affective disorders,['10.1016/j.jad.2021.12.038']
1516,34951503,Group autonomy enhancing treatment versus cognitive behavioral therapy for anxiety disorders: A cluster-randomized clinical trial.,"BACKGROUND


Although cognitive behavioral therapy (CBT) is effective in the treatment of anxiety disorders, few evidence-based alternatives exist. Autonomy enhancing treatment (AET) aims to decrease the vulnerability for anxiety disorders by targeting underlying autonomy deficits and may therefore have similar effects on anxiety as CBT, but yield broader effects.
METHODS


A multicenter cluster-randomized clinical trial was conducted including 129 patients with DSM-5 anxiety disorders, on average 33.66 years of age (SD = 12.57), 91 (70.5%) female, and most (92.2%) born in the Netherlands. Participants were randomized over 15-week groupwise AET or groupwise CBT and completed questionnaires on anxiety, general psychopathology, depression, quality of life, autonomy-connectedness and self-esteem, pre-, mid-, and posttreatment, and after 3, 6, and 12 months (six measurements).
RESULTS


Contrary to the hypotheses, effects on the broader outcome measures did not differ between AET and CBT (d = .16 or smaller at post-test). Anxiety reduction was similar across conditions (d = .059 at post-test) and neither therapy was superior on long term.
CONCLUSION


This was the first clinical randomized trial comparing AET to CBT. The added value of AET does not seem to lie in enhanced effectiveness on broader outcome measures or on long term compared to CBT. However, the study supports the effectiveness of AET and thereby contributes to extended treatment options for anxiety disorders.",2022,"Anxiety reduction was similar across conditions (d = .059 at post-test) and neither therapy was superior on long term.
","['129 patients with DSM-5 anxiety disorders, on average 33.66 years of age (SD\u2009=\u200912.57), 91 (70.5%) female, and most (92.2%) born in the Netherlands', 'anxiety disorders']","['AET', '15-week groupwise AET or groupwise CBT', 'cognitive behavioral therapy', 'Autonomy enhancing treatment (AET', 'cognitive behavioral therapy (CBT']","['anxiety, general psychopathology, depression, quality of life, autonomy-connectedness and self-esteem', 'Anxiety reduction']","[{'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}]",129.0,0.0562993,"Anxiety reduction was similar across conditions (d = .059 at post-test) and neither therapy was superior on long term.
","[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Kunst', 'Affiliation': 'Department of Medical and Clinical Psychology, Center of Research on Psychological disorders and Somatic diseases (CoRPS), Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Maas', 'Affiliation': 'Department of Medical and Clinical Psychology, Center of Research on Psychological disorders and Somatic diseases (CoRPS), Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'Anton J L M', 'Initials': 'AJLM', 'LastName': 'van Balkom', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel A L M', 'Initials': 'MALM', 'LastName': 'van Assen', 'Affiliation': 'Department of Methodology and Statistics, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kouwenhoven', 'Affiliation': 'PEP Noordwijk, Regional Health Organization Rijncoepel, Noordwijk, The Netherlands.'}, {'ForeName': 'Marrie H J', 'Initials': 'MHJ', 'LastName': 'Bekker', 'Affiliation': 'Department of Medical and Clinical Psychology, Center of Research on Psychological disorders and Somatic diseases (CoRPS), Tilburg University, Tilburg, The Netherlands.'}]",Depression and anxiety,['10.1002/da.23231']
1517,34941725,Pain Reduction in Adults with Limb Spasticity Following Treatment with IncobotulinumtoxinA: A Pooled Analysis.,"Some studies have shown that incobotulinumtoxinA reduces spasticity-associated pain, but further evidence is needed. This exploratory analysis pooled pain-relief data from six Phase 2 or 3 studies of incobotulinumtoxinA (four placebo-controlled studies) for treating upper limb spasticity in adults. Spasticity-associated pain was assessed at baseline and 4 weeks post incobotulinumtoxinA injection using the disability assessment scale (DAS) for pain. Only data for patients with pain at baseline were analysed. Overall, 544 (incobotulinumtoxinA, N = 415; placebo, N = 129) of 937 patients (58.1%) experienced pain at baseline. At Week 4, a significantly greater proportion of incobotulinumtoxinA- (52.1%) than placebo-treated patients (28.7%; Chi-square  p  < 0.0001) showed a response (≥1-point improvement in DAS pain score). In logistic regression analysis, incobotulinumtoxinA-treated patients were 2.6 times more likely to achieve this endpoint than placebo-treated patients. A significant difference between incobotulinumtoxinA and placebo was observed regardless of baseline pain severity. Additionally, 27.1% of incobotulinumtoxinA- versus 12.4% of placebo-treated patients reported complete pain relief at Week 4 ( p  = 0.0006). Pain relief increased with multiple injection cycles. To achieve patient-centred care, pain relief may be considered a treatment goal in adults with spasticity-associated pain regardless of pain severity. This study contributes to understanding the benefits of incobotulinumtoxinA in treating limb spasticity-associated pain.",2021,"At Week 4, a significantly greater proportion of incobotulinumtoxinA- (52.1%) than placebo-treated patients (28.7%; Chi-square  p  < 0.0001) showed a response (≥1-point improvement in DAS pain score).","['Adults with Limb Spasticity Following Treatment with', 'adults with spasticity-associated pain regardless of pain severity', 'adults']","['placebo', 'incobotulinumtoxinA and placebo', 'incobotulinumtoxinA (four placebo-controlled studies', 'IncobotulinumtoxinA', 'incobotulinumtoxinA']","['pain', 'Pain relief', 'disability assessment scale (DAS) for pain', 'baseline pain severity', 'complete pain relief', 'Pain Reduction', 'proportion of incobotulinumtoxinA', 'Spasticity-associated pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",937.0,0.216677,"At Week 4, a significantly greater proportion of incobotulinumtoxinA- (52.1%) than placebo-treated patients (28.7%; Chi-square  p  < 0.0001) showed a response (≥1-point improvement in DAS pain score).","[{'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Wissel', 'Affiliation': 'Department of Neurorehabilitation and Physical Therapy, Vivantes Hospital Spandau, 13585 Berlin, Germany.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Camões-Barbosa', 'Affiliation': 'Centro Hospitalar Universitário de Lisboa Central, 1169-056 Lisbon, Portugal.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Comes', 'Affiliation': 'Merz Pharmaceuticals GmbH, D-60318 Frankfurt am Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Althaus', 'Affiliation': 'Merz Pharmaceuticals GmbH, D-60318 Frankfurt am Main, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Scheschonka', 'Affiliation': 'Merz Pharmaceuticals GmbH, D-60318 Frankfurt am Main, Germany.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Simpson', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Neurology, New York, NY 10029, USA.'}]",Toxins,['10.3390/toxins13120887']
1518,34942679,Skin preparation for prevention of surgical site infection after obstetrics and gynecological abdominal surgery: A quality improvement project.,"BACKGROUND


One of the most common causes of postoperative morbidity is postoperative surgical site infection (SSI). Healthcare-associated infection is a subject of great concern in healthcare services. The goal of the present study is to estimate the relative effectiveness of skin preparation solution chlorhexidine scrub followed by povidone-iodine painting in the prevention of SSIs after caesarean delivery and abdominal gynecological surgery.
MATERIAL AND METHODS


This is a 1-year randomized prospective research done at a tertiary care institution in western Rajasthan. Women who underwent caesarean and gynecological operations were randomly assigned to one of two groups. Enrolled patients were randomly assigned to have the surgical site painted with 10% povidone-iodine or a chlorhexidine-alcohol preparatory scrub followed by povidone-iodine paint. According to the Centres for Disease Control and Prevention criteria, the outcomes were any SSI occurring within a week or during the 30-day follow-up period following the operation, including any superficial or deep SSI.
RESULTS


A total of 251 patients were randomly assigned to two groups. Group A (povidone-iodine paint) received 121 patients, whereas Group B (chlorhexidine scrub + povidone-iodine paint) received 129 cases. The overall SSI rate in the present study was 8.76%. The SSI rate was lower in Group B (chlorhexidine scrub + povidone-iodine paint) as compared to Group A (povidone-iodine paint only) (5.4% vs. 12.4%; p = 0.04).
CONCLUSION


This study highlighted that chlorhexidine-alcohol scrubbing followed by povidone-iodine painting provides superior skin antisepsis in comparison to povidone-iodine painting alone.",2022,"The SSI rate was lower in Group B (chlorhexidine scrub + povidone-iodine paint) as compared to Group A (povidone-iodine paint only) (5.4% vs. 12.4%; p = 0.04).
","['A total of 251 patients', 'Women who underwent caesarean and gynecological operations', 'SSIs after caesarean delivery and abdominal gynecological surgery', 'tertiary care institution in western Rajasthan', 'surgical site infection after obstetrics and gynecological abdominal surgery']","['chlorhexidine scrub + povidone-iodine paint', 'povidone-iodine painting', 'chlorhexidine-alcohol scrubbing', 'surgical site painted with 10% povidone-iodine or a chlorhexidine-alcohol preparatory scrub followed by povidone-iodine paint', 'Group B (chlorhexidine scrub + povidone-iodine paint', 'Skin preparation', 'povidone-iodine paint', 'povidone-iodine painting alone']","['SSI rate', 'overall SSI rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C2946035', 'cui_str': 'Scrubs'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0030206', 'cui_str': 'Paint'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",251.0,0.026197,"The SSI rate was lower in Group B (chlorhexidine scrub + povidone-iodine paint) as compared to Group A (povidone-iodine paint only) (5.4% vs. 12.4%; p = 0.04).
","[{'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Gothwal', 'Affiliation': 'Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Hemanta Kumar', 'Initials': 'HK', 'LastName': 'Pradhan', 'Affiliation': 'All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Yadav', 'Affiliation': 'Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Manoj Kumar', 'Initials': 'MK', 'LastName': 'Gupta', 'Affiliation': 'Department of Community Medicine, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.15137']
1519,34962574,Long-term Effectiveness of Adjuvant Treatment With Catechol-O-Methyltransferase or Monoamine Oxidase B Inhibitors Compared With Dopamine Agonists Among Patients With Parkinson Disease Uncontrolled by Levodopa Therapy: The PD MED Randomized Clinical Trial.,"Importance


Many people with Parkinson disease (PD) develop motor complications that are uncontrolled by levodopa dose adjustment. Among these patients, it is uncertain which drug class is more effective as adjuvant therapy.
Objective


To compare the long-term effects on patient-rated quality of life of adding a dopamine agonist vs a dopamine reuptake inhibitor (DRI), either a monoamine oxidase type B (MAO-B) inhibitor or a catechol-O-methyltransferase (COMT) inhibitor, to levodopa therapy for the treatment of patients with motor complications of PD.
Design, Setting, and Participants


This pragmatic semifactorial (2 × 1) randomized clinical trial recruited from 64 neurology and geriatric clinics (62 in the United Kingdom, 1 in the Czech Republic, and 1 in Russia) between February 23, 2001, and December 15, 2009. A total of 500 patients with idiopathic PD who developed uncontrolled motor complications and did not have dementia were randomly assigned on a 1:1:1 basis using a computerized minimization program. Data were analyzed between 2017 and 2020.
Interventions


Open-label dopamine agonist, MAO-B inhibitor, or COMT inhibitor.
Main Outcomes and Measures


Primary outcomes were scores on the 39-item Parkinson's Disease Questionnaire (PDQ-39) mobility domain and cost-effectiveness. Outcomes were assessed before study entry, at 6 and 12 months after randomization, and annually thereafter. Repeated-measures and log rank analyses were used in an intention-to-treat approach.
Results


Among 500 participants, the mean (SD) age was 73.0 (8.2) years; 314 participants (62.8%) were men. Over a median of 4.5 years (range, 0-13.3 years) of follow-up, the participants in the dopamine agonist group had a mean PDQ-39 mobility score that was 2.4 points (95% CI, -1.3 to 6.0 points) better than that of the combined MAO-B and COMT groups; however, this difference was not significant (P=.20). With regard to DRIs, participants in the MAO-B group had mean PDQ-39 mobility scores that were 4.2 points (95% CI, 0.4-7.9 points; P=.03) better than those of the COMT group and EuroQol 5-dimension 3-level (EQ-5D-3L) utility scores that were 0.05 points (95% CI, 0.003-0.09 points; P=.04) better than the COMT group. Nonsignificant improvements were found in the PDQ-39 summary index (mean difference, 2.2 points; 95% CI, -0.2 to 4.5 points; P=.07) along with nonsignificant reductions in dementia (rate ratio [RR], 0.70; 95% CI, 0.47-1.03; P = .07) and mortality (RR, 0.76; 95% CI, 0.56-1.03; P=.07). When dopamine agonists were compared with MAO-B inhibitors only, the outcomes were similar.
Conclusions and Relevance


In this study, patient-rated quality of life was inferior when COMT inhibitors were used as adjuvant treatment compared with MAO-B inhibitors or dopamine agonists among people with PD who experienced motor complications that were uncontrolled by levodopa therapy. The MAO-B inhibitors produced equivalent disease control, suggesting that these agents may be underused as adjuvant therapy.
Trial Registration


isrctn.org Identifier: ISRCTN69812316; EU Clinical Trials Register Identifier: 2005-001813-16.",2022,"Nonsignificant improvements were found in the PDQ-39 summary index (mean difference, 2.2 points; 95% CI, -0.2 to 4.5 points; P=.07) along with nonsignificant reductions in dementia (rate ratio [RR], 0.70; 95% CI, 0.47-1.03; P = .07) and mortality (RR, 0.76; 95% CI, 0.56-1.03; P=.07).","['Participants\n\n\nThis pragmatic semifactorial (2 × 1) randomized clinical trial recruited from 64 neurology and geriatric clinics (62 in the United Kingdom, 1 in the Czech Republic, and 1 in Russia) between February 23, 2001, and December 15, 2009', 'Patients With Parkinson Disease Uncontrolled by Levodopa Therapy', 'patients with motor complications of PD', 'people with Parkinson disease (PD', '500 patients with idiopathic PD who developed uncontrolled motor complications and did not have dementia', 'mean (SD) age was 73.0 (8.2) years; 314 participants (62.8%) were men', '500 participants']","['COMT', 'levodopa therapy', 'Dopamine Agonists', 'dopamine agonist vs a dopamine reuptake inhibitor (DRI', 'MAO-B inhibitors or dopamine agonists', 'monoamine oxidase type B (MAO-B) inhibitor or a catechol-O-methyltransferase (COMT) inhibitor', 'Catechol-O-Methyltransferase or Monoamine Oxidase B Inhibitors', 'Interventions\n\n\nOpen-label dopamine agonist, MAO-B inhibitor, or COMT inhibitor']","['PDQ-39 summary index', 'mean PDQ-39 mobility scores', 'mean PDQ-39 mobility score', 'mortality', 'EuroQol 5-dimension 3-level (EQ-5D-3L) utility scores', ""39-item Parkinson's Disease Questionnaire (PDQ-39) mobility domain and cost-effectiveness""]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0555968', 'cui_str': 'Elderly assessment clinic'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0242980', 'cui_str': 'Dopamine reuptake inhibitor'}, {'cui': 'C0026454', 'cui_str': 'Amine oxidase (flavin-containing)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0595265', 'cui_str': 'Monoamine oxidase B inhibitor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0595267', 'cui_str': 'Catechol-O-methyltransferase inhibitor'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",500.0,0.343911,"Nonsignificant improvements were found in the PDQ-39 summary index (mean difference, 2.2 points; 95% CI, -0.2 to 4.5 points; P=.07) along with nonsignificant reductions in dementia (rate ratio [RR], 0.70; 95% CI, 0.47-1.03; P = .07) and mortality (RR, 0.76; 95% CI, 0.56-1.03; P=.07).","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gray', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Smitaa', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Birmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ives', 'Affiliation': 'Birmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Rick', 'Affiliation': 'Birmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Woolley', 'Affiliation': 'Birmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Muzerengi', 'Affiliation': 'Department of Neurology, University Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Crispin', 'Initials': 'C', 'LastName': 'Jenkinson', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McIntosh', 'Affiliation': 'Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences. University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Department of Neurology, University Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Clarke', 'Affiliation': 'Birmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2021.4736']
1520,34903538,"Chlorhexidine oral rinses for symptomatic COPD: a randomised, blind, placebo-controlled preliminary study.","OBJECTIVES


Determine the effect of twice-daily chlorhexidine oral rinses on oral and lung microbiota biomass and respiratory symptoms.
SETTING


Single centre.
PARTICIPANTS


Participants were aged 40-85 with chronic obstructive pulmonary disease (COPD) and chronic productive cough or COPD exacerbation within the last year. Exclusions included antibiotics in the previous 2 months and/or those with less than four teeth. Forty-four participants were recruited and 40 completed the study.
INTERVENTION


Participants were randomised 1:1 to twice-daily 0.12% chlorhexidine oral rinses versus placebo for 2 months along with daily diaries. St. George's Respiratory Questionnaire (SGRQ), blood tests, oral rinse and induced sputum were collected at randomisation and the final visit.
PRIMARY AND SECONDARY OUTCOMES


Primary outcome was a change in oral and sputum microbiota biomass. Secondary outcomes included: sputum and oral microbiota Shannon and Simpson diversity and taxonomy; inflammatory markers; Breathlessness, Cough and Sputum Scale and SGRQ scores.
RESULTS


Neither the oral microbiota nor the sputum microbiota biomass decreased significantly in those using chlorhexidine compared with placebo (oral microbiota mean log 10  difference (SE)=-0.103 (0.23), 95% CI -0.59 to 0.38, p=0.665; sputum microbiota 0.80 (0.46), 95% CI -0.15 to 1.75, p=0.096). Chlorhexidine decreased both oral and sputum microbiota alpha (Shannon) diversity (linear regression estimate (SE) oral: -0.349 (0.091), p=0.001; sputum -0.622 (0.169), p=0.001). Chlorhexidine use did not decrease systemic inflammatory markers compared with placebo (C reactive protein (chlorhexidine 1.8±7.5 vs placebo 0.4±6.8, p=0.467), fibrinogen (22.5±77.8 vs 10.0±77.0, p=0.406) or leucocytes (0.2±1.8 vs 0.5±1.8, p=0.560)). Chlorhexidine use decreased SGRQ scores compared with placebo (chlorhexidine -4.7±8.0 vs placebo 1.7±8.9, p=0.032).
CONCLUSIONS


We did not detect a significant difference in microbiota biomass due to chlorhexidine use. Chlorhexidine decreased oral and sputum microbiota alpha diversity and improved respiratory health-related quality of life compared with placebo.
TRIAL REGISTRATION


NCT02252588.",2021,"Neither the oral microbiota nor the sputum microbiota biomass decreased significantly in those using chlorhexidine compared with placebo (oral microbiota mean log 10  difference (SE)=-0.103 (0.23), 95% CI -0.59 to 0.38, p=0.665; sputum microbiota 0.80 (0.46), 95% CI -0.15 to 1.75, p=0.096).","['Single centre', 'Forty-four participants were recruited and 40 completed the study', 'symptomatic COPD', 'Participants were aged 40-85 with chronic obstructive pulmonary disease (COPD) and chronic productive cough or COPD exacerbation within the last year']","['placebo', 'Chlorhexidine', 'placebo (C reactive protein (chlorhexidine', 'Chlorhexidine oral rinses', 'chlorhexidine oral rinses versus placebo', 'placebo (chlorhexidine', 'chlorhexidine oral rinses', 'chlorhexidine']","['oral microbiota nor the sputum microbiota biomass', 'microbiota biomass', 'oral and lung microbiota biomass and respiratory symptoms', 'oral and sputum microbiota alpha diversity and improved respiratory health-related quality of life', 'systemic inflammatory markers', ""St. George's Respiratory Questionnaire (SGRQ), blood tests, oral rinse and induced sputum"", 'oral and sputum microbiota alpha (Shannon) diversity', 'SGRQ scores', 'change in oral and sputum microbiota biomass', 'fibrinogen', 'sputum and oral microbiota Shannon and Simpson diversity and taxonomy; inflammatory markers; Breathlessness, Cough and Sputum Scale and SGRQ scores']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0239134', 'cui_str': 'Productive cough'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",44.0,0.398537,"Neither the oral microbiota nor the sputum microbiota biomass decreased significantly in those using chlorhexidine compared with placebo (oral microbiota mean log 10  difference (SE)=-0.103 (0.23), 95% CI -0.59 to 0.38, p=0.665; sputum microbiota 0.80 (0.46), 95% CI -0.15 to 1.75, p=0.096).","[{'ForeName': 'Alexa A', 'Initials': 'AA', 'LastName': 'Pragman', 'Affiliation': 'Department of Medicine, Minneapolis VA Health Care System, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Fieberg', 'Affiliation': 'Coordinating Center for Biometric Research, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Cavan S', 'Initials': 'CS', 'LastName': 'Reilly', 'Affiliation': 'Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wendt', 'Affiliation': 'Department of Medicine, Minneapolis VA Health Care System, Minneapolis, Minnesota, USA wendt005@umn.edu.'}]",BMJ open,['10.1136/bmjopen-2021-050271']
1521,34856826,Feasibility and preliminary efficacy of acupuncture for angina in an underserved diverse population.,"PURPOSE


Stable angina is ischemic chest pain on exertion or with emotional stress. Despite guideline-directed therapy, up to 30% of patients have suboptimal pain relief. The aims of this study were to: (1) determine the feasibility and acceptability of a randomized controlled trial (RCT) of acupuncture; and (2) evaluate preliminary efficacy of acupuncture with respect to reduction of pain and increased functional status and health-related quality of life (HRQoL).
METHODS


Participants with stable angina for ⩾1 month received either a standardized acupuncture protocol, twice per week for 5 weeks, or an attention control protocol. Measures included the McGill Pain Questionnaire (average pain intensity (API), pain now) and the Seattle Angina Questionnaire-7 (functional status, symptoms, and HRQoL). Feasibility was defined as ⩾80% recruitment, ⩾75% retention following enrollment, and ⩾80% completion. Descriptive statistics and mixed-effects linear regression were used for analysis.
RESULTS


The sample (n = 24) had a mean age of 59 ± 12 years, was predominantly female (63%), and represented minority groups (8% White, 52% Black, 33% Hispanic, and 8% Other). Feasibility was supported by 79% retention and 89% completion rates. The recruitment rate (68%) was slightly lower than expected. Acceptability scores were 87.9% for the acupuncture group and 51.7% for the control group. Outcomes were significantly better for the acupuncture versus control groups (API, b = -2.1 (1.1), p = 0.047; functional status, b = 27.6 (7.2), p < 0.001; and HRQoL, b = 38.8 (11.9), p = 0.001).
CONCLUSIONS AND IMPLICATIONS


Acupuncture was feasible and acceptable in our diverse sample. We were slightly under the recruitment target of 80%, but participants who started the study had a high likelihood of completing it. Acupuncture shows promise for stable angina, but its effectiveness needs to be confirmed by a larger, adequately powered RCT.
TRIAL REGISTRATION NUMBER


NCT02914834 (ClinicalTrials.gov).",2022,"Outcomes were significantly better for the acupuncture versus control groups (API, b = -2.1 (1.1), p = 0.047; functional status, b = 27.6 (7.2),","['underserved diverse population', 'Participants with stable angina for ⩾1\u2009month received either a', 'The sample (n\u2009=\u200924) had a mean age of 59\u2009±\u200912\u2009years, was predominantly female (63%), and represented minority groups (8% White, 52% Black, 33% Hispanic, and 8% Other']","['standardized acupuncture protocol', 'Acupuncture', 'acupuncture']","['recruitment rate', 'McGill Pain Questionnaire (average pain intensity (API), pain now) and the Seattle Angina Questionnaire-7 (functional status, symptoms, and HRQoL', 'suboptimal pain relief', 'Acceptability scores', 'feasibility and acceptability', 'pain and increased functional status and health-related quality of life (HRQoL']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.278108,"Outcomes were significantly better for the acupuncture versus control groups (API, b = -2.1 (1.1), p = 0.047; functional status, b = 27.6 (7.2),","[{'ForeName': 'Holli A', 'Initials': 'HA', 'LastName': 'DeVon', 'Affiliation': 'School of Nursing, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Glorieuse', 'Initials': 'G', 'LastName': 'Uwizeye', 'Affiliation': 'Department of Biobehavioral Nursing Science, College of Nursing, University of Illinois Chicago, Chicago, IL, USA.'}, {'ForeName': 'Hui Yan', 'Initials': 'HY', 'LastName': 'Cai', 'Affiliation': 'Department of Acupuncture and Oriental Medicine, National University of Health Sciences, Lombard, IL, USA.'}, {'ForeName': 'Adhir R', 'Initials': 'AR', 'LastName': 'Shroff', 'Affiliation': 'Department of Cardiology, College of Medicine, University of Illinois Chicago, Chicago, IL, USA.'}, {'ForeName': 'Joan E', 'Initials': 'JE', 'LastName': 'Briller', 'Affiliation': 'Department of Cardiology, College of Medicine, University of Illinois Chicago, Chicago, IL, USA.'}, {'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Ardati', 'Affiliation': 'Department of Cardiology, College of Medicine, University of Illinois Chicago, Chicago, IL, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Hoppensteadt', 'Affiliation': 'Department of Pathology and Pharmacology, Loyola University Medical Center, Maywood, IL, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Rountree', 'Affiliation': 'School of Nursing, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Schlaeger', 'Affiliation': 'Department of Human Development Nursing Science, College of Nursing, University of Illinois Chicago, Chicago, IL, USA.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/09645284211055754']
1522,34967750,Evaluation of a Healthy Relationship Smartphone App With Indigenous Young People: Protocol for a Co-designed Stepped Wedge Randomized Trial.,"BACKGROUND


We co-designed a smartphone app, Harmonised, with taitamariki (young people aged 13-17 years) to promote healthy intimate partner relationships. The app also provides a pathway for friends and family, or whānau (indigenous Māori extended family networks), to learn how to offer better support to taitamariki.
OBJECTIVE


The aim of our taitamariki- and Māori-centered study is to evaluate the implementation of the app in secondary schools. The study tests the effectiveness of the app in promoting taitamariki partner relationship self-efficacy (primary outcome).
METHODS


We co-designed a pragmatic, randomized, stepped wedge trial (retrospectively registered on September 12, 2019) for 8 Aotearoa, New Zealand, secondary schools (years 9 through 13). The schools were randomly assigned to implement the app in 1 of the 2 school terms. A well-established evaluation framework (RE-AIM [Reach, Effectiveness, Adoption, Implementation, Maintenance]) guided the selection of mixed data collection methods. Our target sample size is 600 taitamariki enrolled across the 8 schools. Taitamariki will participate by completing 5 web-based surveys over a 15-month trial period. Taitamariki partner relationship self-efficacy (primary outcome) and well-being, general health, cybersafety management, and connectedness (secondary outcomes) will be assessed with each survey. The general effectiveness hypotheses will be tested by using a linear mixed model with nested participant, year-group, and school random effects. The primary analysis will also include testing effectiveness in the Māori subgroup.
RESULTS


The study was funded by the New Zealand Ministry of Business, Innovation, and Employment in October 2015 and approved by the Auckland University of Technology Ethics Committee on May 3, 2017 (application number: 17/71).
CONCLUSIONS


This study will generate robust evidence evaluating the impact of introducing a healthy relationship app in secondary schools on taitamariki partner relationship self-efficacy, well-being, general health, cybersafety management, and connectedness. This taitamariki- and indigenous Māori-centered research fills an important gap in developing and testing strengths-based mobile health interventions in secondary schools.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12619001262190; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377584.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/24792.",2021,"The app also provides a pathway for friends and family, or whānau (indigenous Māori extended family networks), to learn how to offer better support to taitamariki.
","['young people aged 13-17 years', 'With Indigenous Young People', '600 taitamariki enrolled across the 8 schools', 'stepped wedge trial (retrospectively registered on September 12, 2019) for 8 Aotearoa, New Zealand, secondary schools (years 9 through 13']","['Healthy Relationship Smartphone App', 'taitamariki']","['taitamariki partner relationship self-efficacy', 'Taitamariki partner relationship self-efficacy']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.140815,"The app also provides a pathway for friends and family, or whānau (indigenous Māori extended family networks), to learn how to offer better support to taitamariki.
","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Koziol-McLain', 'Affiliation': 'Centre for Interdisciplinary Trauma Research, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'Taupua Waiora Centre for Māori Health Research, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Alain C', 'Initials': 'AC', 'LastName': 'Vandal', 'Affiliation': 'Department of Statistics, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Moana', 'Initials': 'M', 'LastName': 'Eruera', 'Affiliation': 'Oranga Tamariki Ministry for Children, Wellington, New Zealand.'}, {'ForeName': 'Shyamala', 'Initials': 'S', 'LastName': 'Nada-Raja', 'Affiliation': 'Centre for Pacific Health, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Dobbs', 'Affiliation': 'Centre for Interdisciplinary Trauma Research, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roguski', 'Affiliation': 'Kaitiaki Research and Evaluation, Wellington, New Zealand.'}, {'ForeName': 'Te Wai', 'Initials': 'TW', 'LastName': 'Barbarich-Unasa', 'Affiliation': 'Centre for Interdisciplinary Trauma Research, Auckland University of Technology, Auckland, New Zealand.'}]",JMIR research protocols,['10.2196/24792']
1523,34929354,Efficacy and therapeutic reactions of tri-needle-pretreatment combined with painless ALA-PDT for the treatment of moderate-to-severe acne vulgaris: A randomized controlled trial.,"BACKGROUND


Our clinical experience suggests that pretreatment of the original lesions may be crucial for enhancing the efficacy of 5-aminolevulinic acid-photodynamic therapy (ALA-PDT) in moderate-to-severe acne vulgaris. We performed this randomized controlled trial (RCT) to validate this observation.
METHODS


Efficacy and therapeutic reactions between tri-needle-pretreatment with ALA-PDT (TP-PDT) and conventional ALA-PDT without pretreatment (NP-PDT) were compared. In TP-PDT group, tri-needle-pretreatment was performed using comedone extractors, fire needles, or plum-blossom needles, according to the lesion type. In the TP-PDT group, 5% ALA cream was applied to lesions 30 min before illumination (LED red light: 633±10 nm, 40 mW/cm 2 , 150 J/cm 2 ). In the NP-PDT group, 5% ALA cream was applied 1 h before illumination (60 mW/cm 2 , 72 J/cm 2 ). Patients underwent four sessions, at 1-week intervals. The efficacy was evaluated as the proportion of patients achieving a remarkable effective rate, based on the reduction in the number of lesions. A numeric rating scale was used to assess the severity of pain, erythema, and edema.
RESULTS


Forty-eight patients completed the trial. The proportion of remarkable effective rate was significantly greater and the pain score was significantly lower for the TP-PDT than NP-PDT group. The edema score was significantly higher for the TP-PDT than NP-PDT group. There was no difference in erythema scores between the two groups.
CONCLUSION


The tri-needle-pretreatment can improve the efficacy of ALA-PDT, without an increase in pain, for the treatment of moderate-to-severe acne vulgaris. These qualities make the TP-PDT a promising gold standard pretreatment for ALA-PDT for acne vulgaris.",2022,The proportion of remarkable effective rate was significantly greater and the pain score was significantly lower for the TP-PDT than NP-PDT group.,"['moderate-to-severe acne vulgaris', 'Forty-eight patients completed the trial']","['tri-needle-pretreatment with ALA-PDT (TP-PDT) and conventional ALA-PDT without pretreatment (NP-PDT', '5-aminolevulinic acid-photodynamic therapy (ALA-PDT', 'tri-needle-pretreatment combined with painless ALA-PDT', 'ALA cream']","['erythema scores', 'pain', 'severity of pain, erythema, and edema', 'numeric rating scale', 'Efficacy and therapeutic reactions', 'edema score', 'pain score', 'proportion of remarkable effective rate']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0405198,The proportion of remarkable effective rate was significantly greater and the pain score was significantly lower for the TP-PDT than NP-PDT group.,"[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yutong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Linglin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhongxia', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: wangxiuli_1400023@tongji.edu.cn.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102680']
1524,34931904,Walking meditation versus balance training for improving balance abilities among older adults with history of fall: A randomized controlled trial.,"OBJECTIVE


To investigate improvement in balance abilities compared between walking meditation and balance training among older adults with history of fall.
INTERVENTIONS


Walking meditation or mindfulness meditation whilst standing and moving ( n  = 35) or balance training ( n  = 33) 20-30 min/day, 5-7 days/week for 24 weeks was performed at home.
MAIN OUTCOMES


The primary outcomes were dynamic balance abilities as assessed by Timed Up and Go test (TUGT), and static balance as assessed by Functional Reach Test (FRT) and Single Leg Stance Test (SLST). The secondary outcomes were quality of life as measured by the EuroQOL 5-dimensions 5-levels (EQ-5D-5L), and mental health as evaluated by the Thai Geriatric Mental Health Assessment Tool-15 (TGMHA-15). All outcomes were assessed at baseline, 6 months, and 9 months. Self-reported compliance, adverse events, and patient satisfaction were recorded at 6 and 9 months.
RESULTS


The mean age was 69 years (range: 60-85). No significant difference was observed between groups for the 3 primary outcome measures. The mean difference (95% confidence interval) between groups was -0.48 (-1.40, 0.44) for TUGT, -1.11 (-3.66, 1.45) for FRT, and 0.82 (-5.03, 6.67) for SLST. The EQ-5D-5L and TGMHA-15 also showed no significant difference between groups. Most participants were in good compliance with the exercise protocol (48.3-68.0%), and no serious adverse events were reported.
CONCLUSION


Our results showed walking meditation to be comparable to balance training for improving balance abilities in older adults with history of fall. Walking meditation may be considered an alternative treatment for improving balance abilities in this patient population.",2022,Our results showed walking meditation to be comparable to balance training for improving balance abilities in older adults with history of fall.,"['The mean age was 69 years (range: 60-85', ' n \u2009=\u200933) 20-30', 'older adults with history of fall']","['balance training', 'Walking meditation or mindfulness meditation whilst standing and moving ( n \u2009=\u200935) or balance training', 'Walking meditation versus balance training', 'walking meditation', 'Walking meditation', 'walking meditation and balance training']","['quality of life as measured by the EuroQOL 5-dimensions 5-levels (EQ-5D-5L), and mental health as evaluated by the Thai Geriatric Mental Health Assessment Tool-15 (TGMHA-15', 'balance abilities', 'Self-reported compliance, adverse events, and patient satisfaction', 'dynamic balance abilities as assessed by Timed Up and Go test (TUGT), and static balance as assessed by Functional Reach Test (FRT) and Single Leg Stance Test (SLST', 'serious adverse events']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C2720502', 'cui_str': 'Mental health assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",,0.0964732,Our results showed walking meditation to be comparable to balance training for improving balance abilities in older adults with history of fall.,"[{'ForeName': 'Chalida', 'Initials': 'C', 'LastName': 'Phoobangkerdphol', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, 65106Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Patchara', 'Initials': 'P', 'LastName': 'Limampai', 'Affiliation': 'Division of Rehabilitation Psychology and Recreation, Department of Rehabilitation Medicine, 65106Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sirinuch', 'Initials': 'S', 'LastName': 'Dasri', 'Affiliation': 'Division of Surgical Nursing, Department of Nursing, Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Vilai', 'Initials': 'V', 'LastName': 'Kuptniratsaikul', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, 65106Mahidol University, Bangkok, Thailand.'}]",Clinical rehabilitation,['10.1177/02692155211068232']
1525,34931854,Effectiveness of brief patient information materials for promoting correct beliefs about imaging and inevitable consequences of low back pain: A randomised controlled trial.,"OBJECTIVE


To investigate what format for providing patient information (i.e. written summary, infographic or video animation) is most effective for promoting correct beliefs about imaging and inevitable consequences of low back pain (LBP).
DESIGN


Randomised controlled trial.
SETTING/PATIENTS


One hundred and fifty-nine patients with non-specific LBP were recruited from outpatient physiotherapy clinics.
INTERVENTION


Participants were randomised to receive patient information in one of three formats: video animation, infographic or written summary. Patients were allowed to read or watch the materials for up to 20 min.
MEASUREMENTS


Outcome were assessed before and immediately after the intervention. The primary outcome was the Back Beliefs Questionnaire. The secondary outcome was beliefs about imaging for LBP assessed by two questions.
RESULTS


All 159 patients completed the study. Our findings revealed no difference between groups for the Back Beliefs Questionnaire. Correct beliefs about imaging were more likely with the infographic than the video animation (Question 1- Odds Ratio [OR] = 3.9, 95% confidence interval [CI]: 1.7, 8.7; Question 2- OR = 6.8, 95%CI: 2.7, 17.2) and more likely with the written summary than the video animation (Question 1- OR = 3.3, 95%CI: 1.5, 7.4; Question 2- OR = 3.7, 95%CI: 1.6, 8.5). No difference between infographic and written summary formats were reported for the questions assessing LBP imaging beliefs.
CONCLUSION


The three materials were equally effective in improving patient's general beliefs about LBP care. However, the traditional written summary or infographic formats were more effective than the video animation format for improving beliefs about imaging for LBP.",2022,"Correct beliefs about imaging were more likely with the infographic than the video animation (Question 1- Odds Ratio [OR] = 3.9, 95% confidence interval [CI]: 1.7, 8.7; Question 2- OR = 6.8, 95%CI: 2.7, 17.2) and more likely with the written summary than the video animation (Question 1- OR = 3.3, 95%CI: 1.5, 7.4;","['One hundred and fifty-nine patients with non-specific LBP were recruited from outpatient physiotherapy clinics', 'All 159 patients completed the study', 'low back pain']","['video animation, infographic or written summary', 'brief patient information materials']","['beliefs about imaging for LBP assessed by two questions', 'Back Beliefs Questionnaire']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0376650', 'cui_str': 'Animation'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",159.0,0.12942,"Correct beliefs about imaging were more likely with the infographic than the video animation (Question 1- Odds Ratio [OR] = 3.9, 95% confidence interval [CI]: 1.7, 8.7; Question 2- OR = 6.8, 95%CI: 2.7, 17.2) and more likely with the written summary than the video animation (Question 1- OR = 3.3, 95%CI: 1.5, 7.4;","[{'ForeName': 'Leandro M', 'Initials': 'LM', 'LastName': 'Diniz', 'Affiliation': 'Department of Physical Therapy, 28114Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brasil.'}, {'ForeName': 'Crystian B', 'Initials': 'CB', 'LastName': 'Oliveira', 'Affiliation': 'Faculty of Medicine, 28108University of Western São Paulo (UNOESTE), Presidente Prudente, Sao Paulo, Brazil.'}, {'ForeName': 'Gustavo C', 'Initials': 'GC', 'LastName': 'Machado', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Arianne P', 'Initials': 'AP', 'LastName': 'Verhagen', 'Affiliation': 'Discipline of Physiotherapy, Graduate School of Health, 1994University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Daysiane A M', 'Initials': 'DAM', 'LastName': 'Fernandes', 'Affiliation': 'Department of Physical Therapy, 28114Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brasil.'}, {'ForeName': 'Marcia R', 'Initials': 'MR', 'LastName': 'Franco', 'Affiliation': 'Department of Physical Therapy, 218459Centro Universitário UNA, Belo Horizonte, Brasil.'}, {'ForeName': 'Thales R', 'Initials': 'TR', 'LastName': 'Souza', 'Affiliation': 'Department of Physical Therapy, 28114Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brasil.'}, {'ForeName': 'Rafael Z', 'Initials': 'RZ', 'LastName': 'Pinto', 'Affiliation': 'Department of Physical Therapy, 28114Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brasil.'}]",Clinical rehabilitation,['10.1177/02692155211065974']
1526,34922048,"Comment on:""Ketamine vs haloperidol for prevention of cognitive dysfunction and postoperative delirium: A phase IV multicentre randomised placebo-controlled double-blind clinical trial"".",,2022,,[],"['placebo', 'Comment on:""Ketamine vs haloperidol']",['cognitive dysfunction and postoperative delirium'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}]","[{'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}]",,0.770788,,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Hebei General Hospital, Shijiazhuang, China.'}, {'ForeName': 'Dongdong', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Hebei General Hospital, Shijiazhuang, China.'}, {'ForeName': 'Jianli', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Hebei General Hospital, Shijiazhuang, China. Electronic address: hblijianli123@163.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110634']
1527,34933930,Density strips: visualisation of uncertainty in clinical data summaries and research findings.,"The disproportionate focus on statistical significance in reporting and interpreting clinical research studies contributes to publication bias and encourages selective reporting. This highlights a need for alternative approaches that clearly communicate the uncertainty in the data, enabling researchers to provide a more nuanced interpretation of clinical research findings.Our purpose in this article is to introduce the density strip method as one potential approach that might act as a bridge between data visualisation for descriptive purposes and formal statistical inference. We build on existing theory, translating it to the applied research context to illustrate its utility to clinical researchers.We achieve this by considering an exemplar clinical trial, Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial (MS-SMART). MS-SMART was a multiarm randomised placebo-controlled trial of three potentially neuroprotective drugs in secondary progressive MS. We illustrate through MS-SMART the potential of the density strip as an effective visualisation of the distribution of clinical trial outcomes and as a complementary approach to aid the interpretation of formal, inferential, statistical analysis.We conclude by summarising the advantages and disadvantages of the density strip methodology and provide suggestions for its potential extensions and possible further uses.",2021,"We illustrate through MS-SMART the potential of the density strip as an effective visualisation of the distribution of clinical trial outcomes and as a complementary approach to aid the interpretation of formal, inferential, statistical analysis.",[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],3.0,0.130004,"We illustrate through MS-SMART the potential of the density strip as an effective visualisation of the distribution of clinical trial outcomes and as a complementary approach to aid the interpretation of formal, inferential, statistical analysis.","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Weir', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, The University of Edinburgh, Edinburgh, UK christopher.weir@ed.ac.uk.'}, {'ForeName': 'Adrian W', 'Initials': 'AW', 'LastName': 'Bowman', 'Affiliation': 'School of Mathematics and Statistics, University of Glasgow, Glasgow, UK.'}]",BMJ evidence-based medicine,['10.1136/bmjebm-2021-111746']
1528,34986436,Persistent effects of temporary incentives: Evidence from a nationwide health insurance experiment.,Temporary incentives are offered in anticipation of persistent effects that are seldom estimated. We use a nationwide randomized experiment in the Philippines to estimate effects of two incentives for health insurance three years after their withdrawal. We find that both temporary incentives had persistent effects on enrollment. A premium subsidy had a small but highly persistent effect. Application assistance offered to those initially unresponsive to the subsidy had a much larger but less persistent effect. The subsidy persuaded those with higher initial stated willingness to pay to enroll and keep enrolling. The offer of application assistance to initial non-compliers with the subsidy achieved a larger immediate effect by drawing in those who stated they valued insurance less and were less likely to re-enroll when the incentives were withdrawn.,2022,A premium subsidy had a small but highly persistent effect.,[],[],[],[],[],[],,0.0281565,A premium subsidy had a small but highly persistent effect.,"[{'ForeName': 'Aurélien', 'Initials': 'A', 'LastName': 'Baillon', 'Affiliation': 'Erasmus School of Economics, Erasmus University Rotterdam, Tinbergen Institute Netherlands. Electronic address: baillon@ese.eur.nl.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Capuno', 'Affiliation': 'School of Economics, University of the Philippines Diliman Philippines. Electronic address: jjcapuno@gmail.com.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': ""O'Donnell"", 'Affiliation': 'Erasmus School of Economics, Erasmus University Rotterdam, Tinbergen Institute Netherlands; Faculty of Economics and Business, University of Lausanne, Switzerland; Erasmus School of Health Policy and Management, Erasmus University Rotterdam Netherlands. Electronic address: odonnell@ese.eur.nl.'}, {'ForeName': 'Carlos Antonio', 'Initials': 'CA', 'LastName': 'Tan', 'Affiliation': 'School of Economics, University of the Philippines Diliman Philippines. Electronic address: carloztan@yahoo.com.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'van Wilgenburg', 'Affiliation': 'Erasmus School of Health Policy and Management, Erasmus University Rotterdam Netherlands. Electronic address: vanwilgenburg@eshpm.eur.nl.'}]",Journal of health economics,['10.1016/j.jhealeco.2021.102580']
1529,34922649,"Namilumab or infliximab compared with standard of care in hospitalised patients with COVID-19 (CATALYST): a randomised, multicentre, multi-arm, multistage, open-label, adaptive, phase 2, proof-of-concept trial.","BACKGROUND


Dysregulated inflammation is associated with poor outcomes in COVID-19. We aimed to assess the efficacy of namilumab (a granulocyte-macrophage colony stimulating factor inhibitor) and infliximab (a tumour necrosis factor inhibitor) in hospitalised patients with COVID-19, to prioritise agents for phase 3 trials.
METHODS


In this randomised, multicentre, multi-arm, multistage, parallel-group, open-label, adaptive, phase 2, proof-of-concept trial (CATALYST), we recruited patients (aged ≥16 years) admitted to hospital with COVID-19 pneumonia and C-reactive protein (CRP) concentrations of 40 mg/L or greater, at nine hospitals in the UK. Participants were randomly assigned with equal probability to usual care or usual care plus a single intravenous dose of namilumab (150 mg) or infliximab (5 mg/kg). Randomisation was stratified by care location within the hospital (ward vs intensive care unit [ICU]). Patients and investigators were not masked to treatment allocation. The primary endpoint was improvement in inflammation, measured by CRP concentration over time, analysed using Bayesian multilevel models. This trial is now complete and is registered with ISRCTN, 40580903.
FINDINGS


Between June 15, 2020, and Feb 18, 2021, we screened 299 patients and 146 were enrolled and randomly assigned to usual care (n=54), namilumab (n=57), or infliximab (n=35). For the primary outcome, 45 patients in the usual care group were compared with 52 in the namilumab group, and 29 in the usual care group were compared with 28 in the infliximab group. The probabilities that the interventions were superior to usual care alone in reducing CRP concentration over time were 97% for namilumab and 15% for infliximab; the point estimates for treatment-time interactions were -0·09 (95% CI -0·19 to 0·00) for namilumab and 0·06 (-0·05 to 0·17) for infliximab. 134 adverse events occurred in 30 (55%) of 55 patients in the namilumab group compared with 145 in 29 (54%) of 54 in the usual care group. 102 adverse events occurred in 20 (69%) of 29 patients in the infliximab group compared with 112 in 17 (50%) of 34 in the usual care group. Death occurred in six (11%) patients in the namilumab group compared with ten (19%) in the usual care group, and in four (14%) in the infliximab group compared with five (15%) in the usual care group.
INTERPRETATION


Namilumab, but not infliximab, showed proof-of-concept evidence for reduction in inflammation-as measured by CRP concentration-in hospitalised patients with COVID-19 pneumonia. Namilumab should be prioritised for further investigation in COVID-19.
FUNDING


Medical Research Council.",2022,The probabilities that the interventions were superior to usual care alone in reducing CRP concentration over time were 97% for namilumab and 15% for infliximab; the point estimates for treatment-time interactions were -0·09 (95% CI -0·19 to 0·00) for namilumab and 0·06 (-0·05 to 0·17) for infliximab.,"['hospitalised patients with COVID-19 (CATALYST', 'hospitalised patients with COVID-19 pneumonia', 'hospitalised patients with COVID-19, to prioritise agents for phase 3 trials', 'Between June 15, 2020, and Feb 18, 2021, we screened 299 patients and 146 were enrolled and randomly assigned to usual care (n=54), namilumab (n=57), or', 'recruited patients (aged ≥16 years) admitted to hospital with COVID-19 pneumonia and C-reactive protein (CRP) concentrations of 40 mg/L or greater, at nine hospitals in the UK']","['namilumab (a granulocyte-macrophage colony stimulating factor inhibitor) and infliximab', 'Namilumab or infliximab', 'equal probability to usual care or usual care plus a single intravenous dose of namilumab (150 mg) or infliximab', 'infliximab']","['102 adverse events', 'CRP concentration', 'improvement in inflammation, measured by CRP concentration', 'Death', '134 adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3273714', 'cui_str': 'namilumab'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C3273714', 'cui_str': 'namilumab'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4517565', 'cui_str': '134'}]",299.0,0.0461072,The probabilities that the interventions were superior to usual care alone in reducing CRP concentration over time were 97% for namilumab and 15% for infliximab; the point estimates for treatment-time interactions were -0·09 (95% CI -0·19 to 0·00) for namilumab and 0·06 (-0·05 to 0·17) for infliximab.,"[{'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Fisher', 'Affiliation': 'Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK; Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK; National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. Electronic address: b.fisher@bham.ac.uk.'}, {'ForeName': 'Tonny', 'Initials': 'T', 'LastName': 'Veenith', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK; Department of Critical Care Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Slade', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Gaskell', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Rowland', 'Affiliation': 'Kadoorie Centre for Critical Care Research, Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Whitehouse', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK; Department of Critical Care Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Scriven', 'Affiliation': 'Institute of Microbiology and Infection, University of Birmingham, Birmingham, UK; Department of Infectious Diseases, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Dhruv', 'Initials': 'D', 'LastName': 'Parekh', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK; Department of Critical Care Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Department of Respiratory Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Madhu S', 'Initials': 'MS', 'LastName': 'Balasubramaniam', 'Affiliation': 'Department of Critical Care Medicine, Royal Bolton Hospital, Bolton, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Cooke', 'Affiliation': 'Department of Infectious Disease, Imperial College London, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Morley', 'Affiliation': 'Department of Haematology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Gabriel', 'Affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Wise', 'Affiliation': 'Department of Critical Care Medicine, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Porter', 'Affiliation': 'Department of Respiratory Medicine, University College Hospital, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McShane', 'Affiliation': 'Jenner Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ling-Pei', 'Initials': 'LP', 'LastName': 'Ho', 'Affiliation': 'Medical Research Council Human Immunology Unit, Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, UK; Oxford Interstitial Lung Disease Service, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Newsome', 'Affiliation': 'Centre for Liver and Gastrointestinal Research, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK; National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rowe', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK; National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Rowena', 'Initials': 'R', 'LastName': 'Sharpe', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Thickett', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK; Department of Respiratory Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Bion', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK; Department of Critical Care Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'Oxford Clinical Trials Research Unit, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Kearns', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK; National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00460-4']
1530,34951009,Prognostic impact of TP53 mutation in newly diagnosed diffuse large B-cell lymphoma patients treated in the FIL-DLCL04 trial.,"The prognostic role of TP53 disruption has been established in diffuse large B-cell lymphoma (DLBCL). Aim of this analysis was to correlate TP53 mutations by Sanger sequencing, cell of origin (COO) profile by Lymph2Cx panel on the NanoString platform and MYC, BCL2 and BCL6 overexpression or re-arrangements by immunohistochemistry (IHC) and fluorescent in-situ hybridization (FISH), with outcome in DLBCL patients enrolled into the FIL-DLCL04 trial (NCT00499018). One hundred and twenty-five DLBCL patients with tumour block available were analyzed. TP53 was mutated in 11/125 (9%) cases; 60/125 patients received high-dose chemoimmunotherapy up-front, as for the randomization arm; COO was reported in 88 patients: 48 germinal centre B-cell like, 25 activated B-cell like and 17 unclassified; 26 patients were double expressors in IHC and 11 double hit in FISH. After a median follow-up of 72 months, five-year failure-free survival (FFS) for TP53 mutated versus wild-type was 24% and 72%, and five-year overall survival (OS) was 34% and 83%, respectively. Adjusted hazard ratio (HR) was 2·28 [95% confidence interval (CI) 0·89-5·86, p = 0·086] and 4·05 (95% CI 1·37-11·97, p = 0·011) for FFS and OS, respectively. In this series of young DLBCL patients, TP53 gene mutation identified a poor prognosis subgroup, regardless of treatment and other biological markers.",2022,"Adjusted hazard ratio (HR) was 2·28 [95% confidence interval (CI) 0·89-5·86, p = 0·086] and 4·05","['newly diagnosed diffuse large B-cell lymphoma patients treated in the FIL-DLCL04 trial', 'One hundred and twenty-five DLBCL patients with tumour block available were analyzed']",[],"['overall survival (OS', 'Adjusted hazard ratio (HR', 'five-year failure-free survival (FFS', 'TP53 mutations by Sanger sequencing, cell of origin (COO) profile by Lymph2Cx panel on the NanoString platform and MYC, BCL2 and BCL6 overexpression or re-arrangements by immunohistochemistry (IHC) and fluorescent in-situ hybridization (FISH', 'TP53']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4085648', 'cui_str': 'Tagalog language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0080065', 'cui_str': 'c-myc Proteins'}, {'cui': 'C0376515', 'cui_str': 'bcl-2 Genes'}, {'cui': 'C1448774', 'cui_str': 'BCL6 protein, human'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0162789', 'cui_str': 'Fluorescence in situ hybridization'}]",125.0,0.586973,"Adjusted hazard ratio (HR) was 2·28 [95% confidence interval (CI) 0·89-5·86, p = 0·086] and 4·05","[{'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Chiappella', 'Affiliation': 'Hematology, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Fary', 'Initials': 'F', 'LastName': 'Diop', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Agostinelli', 'Affiliation': 'Pathology Unit, Università degli Studi di Bologna, Bologna, Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Novo', 'Affiliation': 'Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, Torino, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Nassi', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Evangelista', 'Affiliation': 'Unit of Clinical Epidemiology and CPO, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Giovannino', 'Initials': 'G', 'LastName': 'Ciccone', 'Affiliation': 'Unit of Clinical Epidemiology and CPO, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Di Rocco', 'Affiliation': 'Department of Traslational and Precision Medicine, Università La Sapienza, Roma, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Martelli', 'Affiliation': 'Department of Traslational and Precision Medicine, Università La Sapienza, Roma, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Melle', 'Affiliation': 'Haematopathology Division, IRCCS, Istituto Europeo di Oncologia, IEO, Milano, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Moia', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Motta', 'Affiliation': 'Haematopathology Division, IRCCS, Istituto Europeo di Oncologia, IEO, Milano, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Righi', 'Affiliation': 'Pathology Unit, Università degli Studi di Bologna, Bologna, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Santambrogio', 'Affiliation': 'Hematology Unit, Santa Croce e Carle Hospital, Cuneo, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tucci', 'Affiliation': 'Hematology, ASST Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Balzarotti', 'Affiliation': 'Unit of Hematology, Humanitas Clinical and Research Center, Rozzano, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ladetto', 'Affiliation': 'Hematology, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.'}, {'ForeName': 'Stefano A', 'Initials': 'SA', 'LastName': 'Pileri', 'Affiliation': 'Haematopathology Division, IRCCS, Istituto Europeo di Oncologia, IEO, Milano, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gaidano', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Vitolo', 'Affiliation': 'Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, Torino, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of haematology,['10.1111/bjh.17971']
1531,34942085,"Efficacy and safety of elexacaftor plus tezacaftor plus ivacaftor versus tezacaftor plus ivacaftor in people with cystic fibrosis homozygous for F508del-CFTR: a 24-week, multicentre, randomised, double-blind, active-controlled, phase 3b trial.","BACKGROUND


Elexacaftor plus tezacaftor plus ivacaftor is a triple-combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator regimen shown to be generally safe and efficacious in people with cystic fibrosis aged 12 years or older with at least one F508del-CFTR allele. We aimed to assess the magnitude and durability of the clinical effects of this triple combination regimen in people with cystic fibrosis homozygous for the F508del-CFTR mutation.
METHODS


We conducted a multicentre, randomised, double-blind, active-controlled, phase 3b trial of elexacaftor plus tezacaftor plus ivacaftor at 35 medical centres in Australia, Belgium, Germany, and the UK. Eligible participants were those with cystic fibrosis homozygous for the F508del-CFTR mutation, aged 12 years or older with stable disease, and with a percent predicted FEV 1  of 40-90% inclusive. After a 4-week run-in period, in which participants received tezacaftor 100 mg orally once daily and ivacaftor 150 mg orally every 12 h, participants were randomly assigned (1:1) to receive 24 weeks of either elexacaftor 200 mg orally once daily plus tezacaftor 100 mg orally once daily plus ivacaftor 150 mg orally every 12 h (elexacaftor plus tezacaftor plus ivacaftor group) or tezacaftor 100 mg orally once daily plus ivacaftor 150 mg orally every 12 h (tezacaftor plus ivacaftor group). Randomisation was stratified by percent predicted FEV 1 , age at screening visit, and whether the participant was receiving CFTR modulators at the time of the screening visit. Patients, investigators, and sponsor's study execution team were masked to treatment assignment. The primary endpoint was the absolute change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain score from baseline (ie, at the end of the tezacaftor plus ivacaftor run-in period) up to and including week 24. The key secondary endpoint was the absolute change from baseline in percent predicted FEV 1  up to and including week 24; other secondary endpoints were the absolute change from baseline in sweat chloride concentrations up to and including week 24, and safety and tolerability. All endpoints were assessed in all randomised patients who had received at least one dose of their assigned regimen. This study is registered with ClinicalTrials.gov, NCT04105972.
FINDINGS


Between Oct 3, 2019, and July 24, 2020, 176 participants were enrolled. Following the 4-week tezacaftor plus ivacaftor run-in period, 175 participants were randomly assigned (87 to the elexacaftor plus tezacaftor plus ivacaftor group and 88 to the tezacaftor plus ivacaftor group) and dosed in the treatment period. From baseline up to and including week 24, the mean CFQ-R respiratory domain score increased by 17·1 points (95% CI 14·1 to 20·1) in the elexacaftor plus tezacaftor plus ivacaftor group and by 1·2 points (-1·7 to 4·2) in the tezacaftor plus ivacaftor group (least squares mean treatment difference 15·9 points [95% CI 11·7 to 20·1], p<0·0001), the mean percent predicted FEV 1  increased by 11·2 percentage points (95% CI 9·8 to 12·6) in the elexacaftor plus tezacaftor plus ivacaftor group and by 1·0 percentage points (-0·4 to 2·4) in the tezacaftor plus ivacaftor group (least squares mean treatment difference 10·2 percentage points [8·2 to 12·1], p<0·0001), and the mean sweat chloride concentration decreased by 46·2 mmol/L (95% CI 43·7 to 48·7) in the elexacaftor plus tezacaftor plus ivacaftor group and by 3·4 mmol/L (1·0 to 5·8) in the tezacaftor plus ivacaftor group (least squares mean treatment difference -42·8 mmol/L [-46·2 to -39·3], nominal p<0·0001). Most participants (70 [80%] in the elexacaftor plus tezacaftor plus ivacaftor group and 74 [84%] in the tezacaftor plus ivacaftor group) had adverse events that were mild or moderate in severity; serious adverse events occurred in five (6%) of 87 participants in the elexacaftor plus tezacaftor plus ivacaftor group and 14 (16%) of 88 participants in the tezacaftor plus ivacaftor group. One (1%) participant in the elexacaftor plus tezacaftor plus ivacaftor group discontinued treatment due to an adverse event of anxiety and depression. Two (2%) participants in the tezacaftor plus ivacaftor group discontinued treatment due to adverse events of psychotic disorder (n=1) and obsessive-compulsive disorder (n=1).
INTERPRETATION


The elexacaftor plus tezacaftor plus ivacaftor regimen was safe and well tolerated, and led to significant and clinically meaningful improvements in respiratory-related quality of life and lung function, as well as improved CFTR function, changes that were durable over 24 weeks and superior to those seen with tezacaftor plus ivacaftor in this patient population.
FUNDING


Vertex Pharmaceuticals.",2022,"From baseline up to and including week 24, the mean CFQ-R respiratory domain score increased by 17·1 points (95% CI 14·1 to 20·1) in the elexacaftor plus tezacaftor plus ivacaftor group and by 1·2 points (-1·7 to 4·2) in the tezacaftor plus ivacaftor group (least squares mean treatment difference 15·9 points","['Eligible participants were those with cystic fibrosis homozygous for the F508del-CFTR mutation, aged 12 years or older with stable disease, and with a percent predicted FEV 1  of 40-90% inclusive', '175 participants were randomly assigned (87 to the', 'people with cystic fibrosis homozygous for F508del-CFTR', 'people with cystic fibrosis homozygous for the F508del-CFTR mutation', 'at 35 medical centres in Australia, Belgium, Germany, and the UK', 'people with cystic fibrosis aged 12 years or older with at least one F508del-CFTR allele', 'Between Oct 3, 2019, and July 24, 2020, 176 participants were enrolled']","['elexacaftor plus tezacaftor plus ivacaftor group and 88 to the tezacaftor plus ivacaftor', 'elexacaftor plus tezacaftor plus ivacaftor', 'tezacaftor plus ivacaftor', 'elexacaftor plus tezacaftor plus ivacaftor versus tezacaftor plus ivacaftor', 'tezacaftor 100 mg orally once daily and ivacaftor', 'elexacaftor 200 mg orally once daily plus tezacaftor 100 mg orally once daily plus ivacaftor 150 mg orally every 12 h (elexacaftor plus tezacaftor plus ivacaftor group) or tezacaftor 100 mg orally once daily plus ivacaftor']","['safety and tolerability', 'safe and well tolerated', 'mean sweat chloride concentration', 'respiratory-related quality of life and lung function', 'adverse event of anxiety and depression', 'absolute change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain score', 'severity; serious adverse events', 'mean CFQ-R respiratory domain score', 'adverse events', 'adverse events of psychotic disorder (n=1) and obsessive-compulsive disorder (n=1']","[{'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0069304', 'cui_str': 'POU5F1 protein, human'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4550902', 'cui_str': 'tezacaftor 100 MG'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3264622', 'cui_str': 'ivacaftor 150 MG'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}]",175.0,0.263528,"From baseline up to and including week 24, the mean CFQ-R respiratory domain score increased by 17·1 points (95% CI 14·1 to 20·1) in the elexacaftor plus tezacaftor plus ivacaftor group and by 1·2 points (-1·7 to 4·2) in the tezacaftor plus ivacaftor group (least squares mean treatment difference 15·9 points","[{'ForeName': 'Sivagurunathan', 'Initials': 'S', 'LastName': 'Sutharsan', 'Affiliation': 'Department of Pulmonary Medicine, Division of Cystic Fibrosis, University Medicine Essen-Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany. Electronic address: sivagurunathan.sutharsan@rlk.uk-essen.de.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'McKone', 'Affiliation': ""National Referral Center for Adult Cystic Fibrosis, St Vincent's University Hospital, and University College Dublin, Dublin, Ireland.""}, {'ForeName': 'Damian G', 'Initials': 'DG', 'LastName': 'Downey', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Duckers', 'Affiliation': 'All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough, Cardiff, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'MacGregor', 'Affiliation': 'Department of Respiratory Medicine, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tullis', 'Affiliation': ""St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Van Braeckel', 'Affiliation': 'Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wainwright', 'Affiliation': ""Queensland Children's Hospital, University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Danie', 'Initials': 'D', 'LastName': 'Watson', 'Affiliation': ""Adult Cystic Fibrosis Centre, St Bartholomew's Hospital, Barts Health NHS Trust, London, UK.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ahluwalia', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Bote G', 'Initials': 'BG', 'LastName': 'Bruinsma', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Lam', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Yiyue', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Moskowitz', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Waltz', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Mall', 'Affiliation': 'Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany; German Center for Lung Research, Berlin, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00454-9']
1532,34952879,"Targeted Interventions in Tourette's using Advanced Neuroimaging and Stimulation (TITANS): study protocol for a double-blind, randomised controlled trial of transcranial magnetic stimulation (TMS) to the supplementary motor area in children with Tourette's syndrome.","INTRODUCTION


Tourette's syndrome (TS) affects approximately 1% of children. This study will determine the efficacy and safety of paired comprehensive behavioural intervention for tics (CBIT) plus repetitive transcranial magnetic stimulation (rTMS) treatment in children with Tourette's syndrome. We hypothesise that CBIT and active rTMS to the supplementary motor area (SMA) will (1) decrease tic severity, and (2) be associated with changes indicative of enhanced neuroplasticity (eg, changes in in vivo metabolite concentrations and TMS neurophysiology measures).
METHODS AND ANALYSIS


This study will recruit 50 youth with TS, aged 6-18 for a phase II, double-blind, block randomised, sham-controlled trial comparing active rTMS plus CBIT to sham rTMS plus CBIT in a 1:1 ratio. The CBIT protocol is eight sessions over 10 weeks, once a week for 6 weeks and then biweekly. The rTMS protocol is 20 sessions of functional MRI-guided, low-frequency (1 Hz) rTMS targeted to the bilateral SMA over 5 weeks (weeks 2-6). MRI, clinical and motor assessments and neurophysiological evaluations including motor mapping will be performed 1 week before CBIT start, 1 week after rTMS treatment and 1 week after CBIT completion. The primary outcome measure is Tourette's symptom change from baseline to post-CBIT treatment, as measured by the Yale Global Tic Severity Scale. Secondary outcomes include changes in imaging, neurophysiological and behavioural markers.
ETHICS AND DISSEMINATION


Ethical approval by the Conjoint Health Research Ethics Board (REB18-0220). The results of this study will be published in peer-reviewed scientific journals, on ClinicalTrials.gov and shared with the Tourette and OCD Alberta Network. The results will also be disseminated through the Alberta Addictions and Mental Health Research Hub.
TRIAL REGISTRATION


NCT03844919.",2021,This study will determine the efficacy and safety of paired comprehensive behavioural intervention for tics (CBIT) plus repetitive transcranial magnetic stimulation (rTMS) treatment in children with Tourette's syndrome.,"[""children with Tourette's syndrome"", '50 youth with TS, aged 6-18 for a phase II']","['paired comprehensive behavioural intervention for tics (CBIT) plus repetitive transcranial magnetic stimulation (rTMS', 'active rTMS plus CBIT to sham rTMS plus CBIT', 'transcranial magnetic stimulation (TMS']","['efficacy and safety', ""Tourette's symptom change from baseline to post-CBIT treatment, as measured by the Yale Global Tic Severity Scale"", 'changes in imaging, neurophysiological and behavioural markers']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040517', 'cui_str': ""Gilles de la Tourette's syndrome""}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040517', 'cui_str': ""Gilles de la Tourette's syndrome""}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",50.0,0.343044,This study will determine the efficacy and safety of paired comprehensive behavioural intervention for tics (CBIT) plus repetitive transcranial magnetic stimulation (rTMS) treatment in children with Tourette's syndrome.,"[{'ForeName': 'Cynthia K', 'Initials': 'CK', 'LastName': 'Kahl', 'Affiliation': 'Department of Psychiatry, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Swansburg', 'Affiliation': 'Department of Psychiatry, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kirton', 'Affiliation': 'Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Pringsheim', 'Affiliation': 'Department of Psychiatry, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Wilcox', 'Affiliation': 'School and Applied Child Psychology, Werklund School of Education, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Ephrem', 'Initials': 'E', 'LastName': 'Zewdie', 'Affiliation': 'Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Harris', 'Affiliation': 'Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Croarkin', 'Affiliation': 'Psychiatry and Psychology, Mayo Clinic College of Medicine, Rochester, Minnesota, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Nettel-Aguirre', 'Affiliation': 'Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Chenji', 'Affiliation': 'Department of Psychiatry, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'MacMaster', 'Affiliation': 'Department of Psychiatry, University of Calgary, Calgary, Alberta, Canada fmacmast@ucalgary.ca.'}]",BMJ open,['10.1136/bmjopen-2021-053156']
1533,34952123,"Cardiometabolic risk markers during mood-stabilizing treatment: Correlation with drug-specific effects, depressive symptoms and treatment response.","BACKGROUND


Patients with bipolar disorder have higher rates of cardiometabolic comorbidities and mortality. Although guidelines emphasize the importance of cardiovascular monitoring, few studies characterized the cardiometabolic risk profile during treatment and their relation to symptomatology and treatment response.
METHODS


We analyzed data from two similar 24-weeks comparative effectiveness trials, with a combined sample of 770 participants randomized to two different lithium doses, quetiapine (300 mg/day), or standard treatment without lithium. Glucose, lipids and vital signs were measured before and after 24 weeks of treatment. We calculated several cardiovascular risk scores, assessed baseline correlations and compared the four treatment arms via multiple linear regression models.
RESULTS


Higher cholesterol and LDL levels were associated with greater depression severity, showing differential correlations to specific symptoms, particularly agitation, low energy and suicidality. Those randomized to quetiapine showed a significant worsening of cardiometabolic markers during the 24-week trial. Neither baseline nor change in lipid levels correlated with differential treatment response.
LIMITATIONS


Study duration was short from the perspective of cardiometabolic risk markers, and all treatment arms included patients taking adjunct antipsychotics. The trials compared quetiapine to lithium, but not to other medications known to affect similar risk factors.
CONCLUSIONS


Treatment with 300 mg/day quetiapine for 24 weeks, representing a short and common dose course, resulted in increased cardiometabolic risk markers, emphasizing the importance of monitoring during mood-stabilizing treatment. The symptom-specific associations are in line with previous studies in unipolar depression, suggesting a cardiometabolic-depression link that needs to be further studied in bipolar depression.",2022,"Higher cholesterol and LDL levels were associated with greater depression severity, showing differential correlations to specific symptoms, particularly agitation, low energy and suicidality.","['770 participants randomized to two different', 'Patients with bipolar disorder']","['standard treatment without lithium', 'quetiapine', 'lithium doses, quetiapine']","['Cardiometabolic risk markers', 'cardiometabolic comorbidities and mortality', 'Glucose, lipids and vital signs', 'several cardiovascular risk scores', 'cardiometabolic markers', 'lipid levels', 'cardiometabolic risk markers', 'Higher cholesterol and LDL levels']","[{'cui': 'C4517873', 'cui_str': '770'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",770.0,0.0995395,"Higher cholesterol and LDL levels were associated with greater depression severity, showing differential correlations to specific symptoms, particularly agitation, low energy and suicidality.","[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Kuperberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: Mayakuperberg@moh.health.gov.il.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Köhler-Forsberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Psychosis Research Unit, Aarhus University Hospital - Psychiatry, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Alec P', 'Initials': 'AP', 'LastName': 'Shannon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nevita', 'Initials': 'N', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Greenebaum', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Bowden', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Tohen', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Science Center, Albuquerque, NM, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kocsis', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Terence A', 'Initials': 'TA', 'LastName': 'Ketter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Friedman', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ostacher', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, OH and Lindner Center of HOPE, University of Cincinnati College of Medicine, Cincinnati, Mason, OH, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2021.12.047']
1534,34890060,Decision aids for localized prostate cancer in diverse minority men: Primary outcome results from a multicenter cancer care delivery trial (Alliance A191402CD).,"BACKGROUND


Decision aids (DAs) can improve knowledge for prostate cancer treatment. However, the relative effects of DAs delivered within the clinical encounter and in more diverse patient populations are unknown. A multicenter cluster randomized controlled trial with a 2×2 factorial design was performed to test the effectiveness of within-visit and previsit DAs for localized prostate cancer, and minority men were oversampled.
METHODS


The interventions were delivered in urology practices affiliated with the NCI Community Oncology Research Program Alliance Research Base. The primary outcome was prostate cancer knowledge (percent correct on a 12-item measure) assessed immediately after a urology consultation.
RESULTS


Four sites administered the previsit DA (39 patients), 4 sites administered the within-visit DA (44 patients), 3 sites administered both previsit and within-visit DAs (25 patients), and 4 sites provided usual care (50 patients). The median percent correct in prostate cancer knowledge, based on the postvisit knowledge assessment after the intervention delivery, was as follows: 75% for the pre+within-visit DA study arm, 67% for the previsit DA only arm, 58% for the within-visit DA only arm, and 58% for the usual-care arm. Neither the previsit DA nor the within-visit DA had a significant impact on patient knowledge of prostate cancer treatments at the prespecified 2.5% significance level (P = .132 and P = .977, respectively).
CONCLUSIONS


DAs for localized prostate cancer treatment provided at 2 different points in the care continuum in a trial that oversampled minority men did not confer measurable gains in prostate cancer knowledge.",2022,"Neither the previsit DA nor the within-visit DA had a significant impact on patient knowledge of prostate cancer treatments at the prespecified 2.5% significance level (P = .132 and P = .977, respectively).
",['diverse minority men'],"['Decision aids (DAs', 'previsit DA', 'Decision aids']","['prostate cancer knowledge (percent correct on a 12-item measure) assessed immediately after a urology consultation', 'patient knowledge of prostate cancer treatments']","[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}]","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.193401,"Neither the previsit DA nor the within-visit DA had a significant impact on patient knowledge of prostate cancer treatments at the prespecified 2.5% significance level (P = .132 and P = .977, respectively).
","[{'ForeName': 'Jon C', 'Initials': 'JC', 'LastName': 'Tilburt', 'Affiliation': 'Biomedical Ethics Research Program, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zahrieh', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Pacyna', 'Affiliation': 'Biomedical Ethics Research Program, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Petereit', 'Affiliation': 'Rapid City Regional Cancer Care Institute, Monument Health, Rapid City, South Dakota.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Kaur', 'Affiliation': 'Department of Hematology and Oncology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Rapkin', 'Affiliation': 'Department of Epidemiology and Population Health, Division of Community Collaboration and Implementation Science, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Grubb', 'Affiliation': 'Department of Urology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Chang', 'Affiliation': 'Department of Colon and Rectal Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Evan Z', 'Initials': 'EZ', 'LastName': 'Kovac', 'Affiliation': 'Department of Urology, Rutgers New Jersey Medical School, Newark, New Jersey.'}, {'ForeName': 'Kara N', 'Initials': 'KN', 'LastName': 'Babaian', 'Affiliation': 'Department of Surgery, Southern Illinois University, Springfield, Illinois.'}, {'ForeName': 'Jeff A', 'Initials': 'JA', 'LastName': 'Sloan', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ethan M', 'Initials': 'EM', 'LastName': 'Basch', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Peil', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Novotny', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Electra D', 'Initials': 'ED', 'LastName': 'Paskett', 'Affiliation': 'Ohio State University College of Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Buckner', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Joyce', 'Affiliation': 'Department of Urology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Montori', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Dominick L', 'Initials': 'DL', 'LastName': 'Frosch', 'Affiliation': 'Palo Alto Medical Foundation Research Institute, Palo Alto, California.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Volk', 'Affiliation': 'Division of Cancer Prevention and Population Sciences, Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Kim', 'Affiliation': 'Division of Urology, Anschutz Medical Center, University of Colorado, Aurora, Colorado.'}]",Cancer,['10.1002/cncr.34062']
1535,34952870,Detecting young people with mental disorders: a cluster-randomised trial of multidisciplinary health teams at the GP office.,"BACKGROUND


Young people with mental health challenges present a major global challenge. More than half of adults with mental disorders experience their onset before age 14, but early detection and intervention may change this course. Shared care with mental health professionals in general practitioner (GP) offices has demonstrated its potential for improvement in these conditions.
AIM


To investigate whether shared care with mental health professionals in GP offices increases the detection of youth's mental health disorders and is associated with a decrease in use of unspecified symptom diagnoses, as a whole and stratified by patient and physician gender and age, and type of consulting physician.
DESIGN AND SETTING


This was a stratified cluster-randomised controlled trial with data extraction from electronic records. Two GP offices were recruited from each of three boroughs. Each borough had 3-8 GP offices. One GP office was randomised to the intervention group and the other to the control group.
METHOD


We used generalised linear mixed models to assess whether the intervention helped GPs identify more International Classification of Primary Care 2 diagnoses of depression, anxiety and unspecified symptoms in youth.
RESULTS


Over a 18-month period between between 2015 and 2017, the intervention helped GPs identify more youth with anxiety (p=0.002 for interaction), but not depression. The increase was most significant among the patients' regular GPs, less when patients met other GPs and least among external substitute physicians. The frequency of diagnoses with unspecified symptoms decreased in the intervention arm.
CONCLUSION


Shared care with mental health professionals located in GP office contributed to increased detection of youth with anxiety symptoms. The increase was most prominent when the primary care physician was the patient's regular GP. GPs need to pay greater attention to detecting anxiety in youth and embrace shared care models, thereby contributing to reduced mental health disorders in this age group.
TRIAL REGISTRATION NUMBER


NCT03624829; Results.",2021,"The increase was most significant among the patients' regular GPs, less when patients met other GPs and least among external substitute physicians.","['Two GP offices were recruited from each of three boroughs', 'Detecting young people with mental disorders', ""youth's mental health disorders"", 'Young people with mental health']",[],"['youth with anxiety', 'frequency of diagnoses with unspecified symptoms']","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.056259,"The increase was most significant among the patients' regular GPs, less when patients met other GPs and least among external substitute physicians.","[{'ForeName': 'Ole Rikard', 'Initials': 'OR', 'LastName': 'Haavet', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway o.r.haavet@medisin.uio.no.'}, {'ForeName': 'Jūratė', 'Initials': 'J', 'LastName': 'Šaltytė Benth', 'Affiliation': 'Health Services Research Unit, Akershus University Hospital, Lorenskog, Norway.'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Gjelstad', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ketil', 'Initials': 'K', 'LastName': 'Hanssen-Bauer', 'Affiliation': 'Division of Health Services Research and Psychiatry, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Mina Piiksi', 'Initials': 'MP', 'LastName': 'Dahli', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Kates', 'Affiliation': 'Department of Psychiatry & Behavioural Neurosciences, Michael G. DeGroote School of Medicine McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Torleif', 'Initials': 'T', 'LastName': 'Ruud', 'Affiliation': 'Division of Health Services Research and Psychiatry, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}]",BMJ open,['10.1136/bmjopen-2021-050036']
1536,34967338,An In-vitro Fracture Strength Assessment of Endodontically Treated Teeth with Different Root-End Materials.,"OBJECTIVE


To assess and compare the fracture strength of endodontically treated teeth when the retrograde preparations were restored either with Biodentine or Endosequence BC RRM Fast set putty or Geristore.
METHODS


One hundred and twenty human mandibular premolars were used and allocated randomly into five groups (n=24 each). Following conventional root canal treatment, and apical root resection, retrograde cavities of 3 mm were prepared using ultrasonic tips. Group 1 (intact, sound teeth), Group 2 (without rootend filling), Groups 3, 4 and 5were allocated for Biodentine, Endosequence BC RRM putty, and Geristore respectively. Thermo-mechanical cyclic loading (TMC) was performed for one section of samples in each group (n=12 each) following which immediate and after TMC fracture resistance was evaluated using the Instron machine. One-way ANOVA followed by Tukey's multiple post-hoc procedures was used for data analysis.
RESULTS


Intact teeth had shown the highest fracture strength values than all other four groups (P<0.05) and resected roots without root-end filling group exhibited the lowest resistance to fracture. Amongst the test groups, Endosequence BC RRM putty displayed improved fracture strength, and Geristore exhibited the least resistance to fracture. Fracture strength values were not statistically different among Endosequence fast set putty and Biodentine group samples immediately and after thermo-mechanical cyclic loading (P=0.5987 and 0.9999 respectively). The fracture strength was notsignificantly different between Geristore and without root-end filling groups (P=0.3530).
CONCLUSION


Endodontically treated teeth with Endosequence BC RRM putty or Biodentine root-end filled teeth had shown better fracture resistance compared to Geristore. Retrofilling with Geristore was not able to improve fracture strength of root canal-treated teeth.",2021,Fracture strength values were not statistically different among Endosequence fast set putty and Biodentine group samples immediately and after thermo-mechanical cyclic loading (P=0.5987 and 0.9999 respectively).,['One hundred and twenty human mandibular premolars'],"['conventional root canal treatment, and apical root resection, retrograde cavities of 3 mm were prepared using ultrasonic tips', 'Endosequence BC RRM putty', 'Thermo-mechanical cyclic loading (TMC', 'Biodentine, Endosequence BC RRM putty, and Geristore respectively', 'Endosequence BC RRM putty or Biodentine root-end filled teeth', 'Biodentine or Endosequence BC RRM Fast set putty or Geristore']","['fracture strength', 'highest fracture strength values', 'fracture resistance', 'Fracture strength values', 'fracture strength, and Geristore exhibited the least resistance to fracture']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0003571', 'cui_str': 'Root amputation, per root'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C0168873', 'cui_str': 'Geristore'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0399066', 'cui_str': 'Insertion of malleable restoration into tooth'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C4704755', 'cui_str': 'Fracture Strength'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0168873', 'cui_str': 'Geristore'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}]",120.0,0.0156301,Fracture strength values were not statistically different among Endosequence fast set putty and Biodentine group samples immediately and after thermo-mechanical cyclic loading (P=0.5987 and 0.9999 respectively).,"[{'ForeName': 'Prasanthi', 'Initials': 'P', 'LastName': 'Penmatsa', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, GITAM Dental College and Hospital, Visakhapatnam, India.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Boddeda', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, GITAM Dental College and Hospital, Visakhapatnam, India.'}, {'ForeName': 'Jyothi', 'Initials': 'J', 'LastName': 'Mandava', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, GITAM Dental College and Hospital, Visakhapatnam, India.'}, {'ForeName': 'Ravichandra', 'Initials': 'R', 'LastName': 'Ravi', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, GITAM Dental College and Hospital, Visakhapatnam, India.'}, {'ForeName': 'Angadala', 'Initials': 'A', 'LastName': 'Priyanka', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, GITAM Dental College and Hospital, Visakhapatnam, India.'}, {'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Pulidindi', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, GITAM Dental College and Hospital, Visakhapatnam, India.'}]",European endodontic journal,['10.14744/eej.2021.55265']
1537,34895798,The effectiveness of motivational messages to intensive care unit nurses during the COVID-19 pandemic.,"OBJECTIVES


To examine the effect of motivational messages on optimism, hopelessness, and life satisfaction of intensive care nurses during the COVID-19 pandemic.
STUDY DESIGN


This is a multicentre, randomized controlled, open-label study.
RESEARCH METHODOLOGY/DESIGN


The study was conducted with a total of 87 nurses working in the COVID-19 intensive care units of three hospitals in Istanbul. Motivational messages were sent via SMS to the participants in the motivational group (n = 41) for 21 days. The data were obtained using a Personal Information Form, the Life Orientation Test, Beck Hopelessness Scale and the Satisfaction with Life Scale.
RESULTS


The nurses' mean age in the motivational and control groups was 28.4 ± 7.6 and 26.9 ± 3.7 years, respectively. Before the messages, no statistically significant difference was found between the two groups in terms of life orientation (p = 0.059), hopelessness (p = 0.214), and satisfaction with life (p = 0.898) scores. After the messages, life orientation (p = 0.042) and life satisfaction (p = 0.040) scores were significantly higher in the motivational group compared with the control group, and the hopelessness score was significantly lower (p = 0.005).
CONCLUSION


According to our study, motivational messages sent to intensive care nurses during the pandemic increased their level of optimism and life satisfaction and decreased their level of hopelessness.
TRIAL REGISTRATION


NCT04751474.",2022,"After the messages, life orientation (p = 0.042) and life satisfaction (p = 0.040) scores were significantly higher in the motivational group compared with the control group, and the hopelessness score was significantly lower (p = 0.005).
",['87 nurses working in the COVID-19 intensive care units of three hospitals in Istanbul'],['motivational messages'],"['optimism, hopelessness, and life satisfaction', 'level of optimism and life satisfaction', 'hopelessness', 'life orientation', 'Life Orientation Test, Beck Hopelessness Scale and the Satisfaction with Life Scale', 'satisfaction with life', 'life satisfaction', 'hopelessness score']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0582640', 'cui_str': 'Life orientation test'}, {'cui': 'C0582612', 'cui_str': 'Beck hopelessness scale'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",87.0,0.0452731,"After the messages, life orientation (p = 0.042) and life satisfaction (p = 0.040) scores were significantly higher in the motivational group compared with the control group, and the hopelessness score was significantly lower (p = 0.005).
","[{'ForeName': 'Selmin', 'Initials': 'S', 'LastName': 'Köse', 'Affiliation': 'Department of Nursing, Health Sciences Faculty, Biruni University, Istanbul, Turkey. Electronic address: skose@biruni.edu.tr.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Gezginci', 'Affiliation': 'Hamidiye Faculty of Nursing, University of Health Sciences Turkey, Istanbul, Turkey. Electronic address: elif.gezginci@sbu.edu.tr.'}, {'ForeName': 'Sonay', 'Initials': 'S', 'LastName': 'Göktaş', 'Affiliation': 'Hamidiye Faculty of Nursing, University of Health Sciences Turkey, Istanbul, Turkey. Electronic address: sonay.goktas@sbu.edu.tr.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Murat', 'Affiliation': 'Department of Nursing, Health Sciences Faculty, Biruni University, Istanbul, Turkey. Electronic address: mmurat@biruni.edu.tr.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2021.103161']
1538,34966526,Evaluation of the Effect of PDCA in Hospital Health Management.,"PDCA plays a very important role in the hygienic management of hospital operating rooms. Before the PDCA management from February 2018 to February 2019, routine hygiene management in the operating room was adopted; after the PDCA management from February 2018 to February 2019, PDCA cycle management was adopted. 500 surgical patients were randomly selected from both groups. We compare the quality control checklist scores of hand hygiene management, environmental hygiene management, medical waste management, and disinfection and isolation management in the routine group and the PDCA group. We also compared the detection rate of pathogenic bacteria in surgical incisions of the routine group and the PDCA group and the infection rate of various surgical incisions, air samples, surface samples, disinfectants, and sterilization rates of sterile items. The PDCA group's hand hygiene management score, environmental hygiene management score, medical waste management score, and disinfection and isolation management score were higher than those in the conventional group ( P  < 0.05). The detection rate of pathogenic bacteria in the PDCA group, the infection rate of type I, type II, and type III incisions, and the total infection rate of surgical incisions were lower than those in the conventional group, and the difference was statistically significant ( P  < 0.05). The qualified rate of air samples and surface samples in the PDCA group was higher than that in the conventional group ( P  < 0.05), and the difference in the qualified rate of disinfectants and sterile items between the two groups was not statistically significant ( P  > 0.05). The hygiene management of the operating room adopts PDCA sustainable improvement management measures to effectively increase the qualification rate of disinfection and sterilization, reduce the detection rate of pathogenic bacteria and infection rate of surgical incisions, and strengthen the management quality of hand hygiene, environmental hygiene, medical waste, and disinfection and isolation.",2021,"The hygiene management of the operating room adopts PDCA sustainable improvement management measures to effectively increase the qualification rate of disinfection and sterilization, reduce the detection rate of pathogenic bacteria and infection rate of surgical incisions, and strengthen the management quality of hand hygiene, environmental hygiene, medical waste, and disinfection and isolation.","['500 surgical patients', 'Hospital Health Management']",['PDCA'],"['qualified rate of air samples and surface samples', 'infection rate of various surgical incisions, air samples, surface samples, disinfectants, and sterilization rates of sterile items', 'total infection rate of surgical incisions', 'detection rate of pathogenic bacteria', 'qualification rate of disinfection and sterilization', 'qualified rate of disinfectants and sterile items', 'hygiene management score, environmental hygiene management score, medical waste management score, and disinfection and isolation management score']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],"[{'cui': 'C1546536', 'cui_str': 'Air sample'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0012682', 'cui_str': 'Disinfectant'}, {'cui': 'C0038280', 'cui_str': 'Sterilization'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0025111', 'cui_str': 'Waste, Medical'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}]",500.0,0.00609155,"The hygiene management of the operating room adopts PDCA sustainable improvement management measures to effectively increase the qualification rate of disinfection and sterilization, reduce the detection rate of pathogenic bacteria and infection rate of surgical incisions, and strengthen the management quality of hand hygiene, environmental hygiene, medical waste, and disinfection and isolation.","[{'ForeName': 'Huanmin', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': 'Party Committee Office, The First Affiliated Hospital of Suchow University, Suzhou 215006, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': 'Propaganda Department of Party Committee, Renmin Hospital of Wuhan University, Wuhan 430060, China.'}]",Journal of healthcare engineering,['10.1155/2021/6778045']
1539,34933416,Muscle function following testosterone replacement in men on opioid therapy for chronic non-cancer pain: A randomized controlled trial.,"BACKGROUND


Chronic pain and opioid treatment are associated with increased risk of male hypogonadism and subsequently decreased muscle function. A diagnosis of hypogonadism is based on the presence of low total testosterone and associated symptoms. The effect of testosterone replacement therapy on muscle function in men with chronic pain and low total testosterone remains to be investigated.
OBJECTIVES


To investigate the effects of testosterone replacement therapy on muscle function and gait performance in men treated with opioids for chronic non-cancer pain.
MATERIALS AND METHODS


A double-blind, placebo-controlled study. Forty-one men (>18 years) with opioid-treated chronic pain and serum total testosterone < 12 nmol/L were randomized to 24 weeks testosterone replacement therapy (testosterone undecanoate injection three times/6 months, n  = 20) or placebo injections (n  = 21). Muscle function was measured as leg press maximal voluntary contraction, leg extension power using the Nottingham power rig and handgrip strength using a handheld dynameter. Gait performance was measured at usual and maximal gait speed on a 10-m track. Body composition (lean body mass and fat mass) was determined by dual-energy X-ray absorptiometry. Mann-Whitney tests were performed on ∆-values (24-0 weeks) between testosterone replacement therapy and placebo.
RESULTS


At baseline, median (interquartile range) age was 55 ± 13 years and BMI was 30.7 ± 5.2 kg/m 2  . ∆-muscle function and ∆-gait performance were similar between testosterone replacement therapy and placebo. Median ∆-leg press maximal voluntary contraction was 174.2 ± 406.7 Newton, following testosterone replacement therapy, and 7.6 ± 419.1 Newton, after placebo, p = 0.091. ∆-lean body mass was significantly higher following testosterone replacement therapy compared to placebo, 3.6 ± 2.7 versus 0.1 ± 3.5 kg, respectively (p < 0.001).
DISCUSSION


Testosterone replacement therapy, compared to placebo, did not improve muscle function or gait performance despite increased lean body mass. Changes in body composition did not infer any changes in muscle function.
CONCLUSION


24 weeks testosterone replacement therapy in opioid-treated men with pain-related male hypogonadism did not improve muscle function.",2022,"Median ∆-leg press maximal voluntary contraction was 174.2 ± 406.7 Newton, following testosterone replacement therapy, and 7.6 ± 419.1 Newton, after placebo, p = 0.091.","['men on opioid therapy for chronic non-cancer pain', 'men with chronic pain and low total testosterone', 'Forty-one men (>18 years) with opioid-treated chronic pain and serum total testosterone', 'men treated with opioids for chronic non-cancer pain', 'opioid-treated men with pain-related male hypogonadism']","['placebo', 'testosterone replacement therapy', 'testosterone replacement', 'testosterone replacement therapy (testosterone undecanoate injection three times/6 months, n\u2009\xa0=\xa020) or placebo injections', 'testosterone replacement therapy and placebo', 'Testosterone replacement therapy']","['muscle function', '∆-muscle function and ∆-gait performance', 'Gait performance', 'Median ∆-leg press maximal voluntary contraction', 'Body composition (lean body mass and fat mass', 'Muscle function', 'muscle function or gait performance despite increased lean body mass', 'muscle function and gait performance', '∆-lean body mass', 'leg press maximal voluntary contraction, leg extension power using the Nottingham power rig and handgrip strength']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0151721', 'cui_str': 'Male hypogonadism'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0076195', 'cui_str': 'Testosterone undecanoate'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0301503', 'cui_str': 'rabies immune globulin, human'}]",41.0,0.178307,"Median ∆-leg press maximal voluntary contraction was 174.2 ± 406.7 Newton, following testosterone replacement therapy, and 7.6 ± 419.1 Newton, after placebo, p = 0.091.","[{'ForeName': 'Mikkel Iwanoff', 'Initials': 'MI', 'LastName': 'Kolind', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Louise Lehmann', 'Initials': 'LL', 'LastName': 'Christensen', 'Affiliation': 'Department of Endocrinology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Caserotti', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Marianne Skovsager', 'Initials': 'MS', 'LastName': 'Andersen', 'Affiliation': 'Department of Endocrinology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Glintborg', 'Affiliation': 'Department of Endocrinology, Odense University Hospital, Odense, Denmark.'}]",Andrology,['10.1111/andr.13147']
1540,34967337,Micro-Computed Tomographic Analysis of the Shaping Ability of XP-Endo Shaper in Oval-Shaped Distal Root Canals of Mandibular Molars.,"OBJECTIVE


To compare the shaping ability of the XP-endo Shaper (XPS) system to the ProTaper Next (PTN) system in oval-shaped distal root canals.
METHODS


From 12 mandibular molars, distal roots with moderately curved single oval canals were randomly assorted to be instrumented with XPS (experimental group) or PTN (control group) and then scanned using micro-computed tomography [Scan 1]. The root canals of the XPS samples were prepared following the manufacturer's instructions using 15 insertions (XPS15) and rescanned [Scan 2]. An additional 10 insertions to the working length were applied, totalling 25 insertions (XPS25), and the roots were rescanned again [Scan 3]. PTN samples were prepared up to the X3 instrument (PTNX3) and rescanned [Scan 2]. The dentine removed and the unprepared areas were assessed. Data were analysed using a t-test with significance at α=0.05.
RESULTS


XPS25 was associated with a significantly greater dentine removal than XPS15 over the entire root canal length and in all three-thirds of the root canal (P<0.05). XPS25 significantly removed more dentine than PTNX3 in only the coronal third (P<0.05). XPS25 was also associated with a significantly smaller percentage of unprepared areas than XPS15 overall and in the coronal third (P<0.05). PTNX3 was associated with a significantly larger percentage of unprepared areas than XPS15 and XPS25 overall and in the coronal and middle thirds (P<0.05).
CONCLUSION


Ten additional movements with XPS significantly improved instrumentation capacity, reducing the percentage of untouched surface areas but also removing more dentine.",2021,XPS25 significantly removed more dentine than PTNX3 in only the coronal third (P<0.05).,"['From 12 mandibular molars, distal roots with moderately curved single oval canals']","['XPS (experimental group) or PTN (control group) and then scanned using micro-computed tomography [Scan 1', 'XPS', 'XP-endo Shaper (XPS) system to the ProTaper', 'PTNX3']","['instrumentation capacity', 'dentine removal', 'percentage of untouched surface areas']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0447373', 'cui_str': 'Distal tooth root'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}]","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.0447691,XPS25 significantly removed more dentine than PTNX3 in only the coronal third (P<0.05).,"[{'ForeName': 'Ane', 'Initials': 'A', 'LastName': 'Poly', 'Affiliation': 'Department of Integrated Clinical Procedures, School of Dentistry, Rio de Janeiro State University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Wei-Ju Louis', 'Initials': 'WL', 'LastName': 'Tseng', 'Affiliation': 'Department of Orthopaedic Surgery, McKay Orthopaedic Research Laboratory, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA;Department of Medicine, Center for Translational Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Marques', 'Affiliation': 'Department of Endodontics, School of Dental Medicine, University of Pennsylvania, Philadelphia, USA.'}, {'ForeName': 'Frank Carsten', 'Initials': 'FC', 'LastName': 'Setzer', 'Affiliation': 'Department of Endodontics, School of Dental Medicine, University of Pennsylvania, Philadelphia, USA.'}, {'ForeName': 'Bekir', 'Initials': 'B', 'LastName': 'Karabucak', 'Affiliation': 'Department of Endodontics, School of Dental Medicine, University of Pennsylvania, Philadelphia, USA.'}]",European endodontic journal,['10.14744/eej.2021.44153']
1541,34967333,Evaluation of Dental Students' Skills Acquisition in Endodontics Using a 3D Printed Tooth Model.,"OBJECTIVE


The purpose of this prospective quantitative study was to assess the improvement of skills among pre-clinical dental students who practiced root canal obturation on a 3D-printed tooth model.
METHODS


Preclinical students at the dental school (n=145) enrolled in the 2-week endodontic rotation course were invited to participate in the study. Four alphabetically distributed intact groups of first-year students were randomly allocated to either the control or the experimental group that obturated canals of a 3D-printed tooth. The plastic model was obtained from a microCT scan and based on an STL data set. The model was an identical replica of a natural mandibular molar that had been instrumented, ready for obturation. The control group did not obturate the tooth model but received identical instruction. Later in the course all students obturated an extracted human mandibular molar tooth. Technical obturation quality was assessed by two blinded evaluators. Radiographs were used to evaluate obturation length and density. Inter-observer reliability of average performance scores was calculated with the intra-class correlation coefficient for both consistency and absolute agreement. Obturation skills of those who practiced with the model were statistically compared to students who did not use the model with the Mann-Whitney U-test.
RESULTS


Inter-observer reliability was very high for both consistency and absolute agreement. No significant differences were found in obturation skills between the experimental and control group (P>0.05).
CONCLUSION


Under the condition of this study, dental students' obturation skills did not significantly improve by further practicing obturation using a 3D-printed model.",2021,"No significant differences were found in obturation skills between the experimental and control group (P>0.05).
","[""Dental Students' Skills Acquisition in Endodontics Using a 3D Printed Tooth Model"", 'Four alphabetically distributed intact groups of first-year students', 'pre-clinical dental students who practiced root canal obturation on a 3D-printed tooth model', 'Preclinical students at the dental school (n=145) enrolled in the 2-week endodontic rotation course were invited to participate in the study']",[],"['obturation skills', 'Technical obturation quality', 'Obturation skills']","[{'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035848', 'cui_str': 'Root canal obturation'}, {'cui': 'C0036376', 'cui_str': 'Dental School'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",4.0,0.0166215,"No significant differences were found in obturation skills between the experimental and control group (P>0.05).
","[{'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Peters', 'Affiliation': 'Department of Endodontics, University of the Pacific, Arthur A. Dugoni School of Dentistry, San Francisco, CA, USA; University of Queensland, School of Dentistry, Brisbane, Qld, Australia.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Scott', 'Affiliation': 'Department of Endodontics, University of the Pacific, Arthur A. Dugoni School of Dentistry, San Francisco, CA, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arias', 'Affiliation': 'Department of Endodontics, University of the Pacific, Arthur A. Dugoni School of Dentistry, San Francisco, CA, USA; Department of Conservative Dentistry, Complutense University, Madrid, Spain.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Lim', 'Affiliation': 'Department of Endodontics, University of the Pacific, Arthur A. Dugoni School of Dentistry, San Francisco, CA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Paque', 'Affiliation': 'Department of Preventive Dentistry, Periodontology and Cariology, School of Dentistry, University of Zurich Dental School, Zurich, Switzerland.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Almassi', 'Affiliation': 'Department of Endodontics, University of the Pacific, Arthur A. Dugoni School of Dentistry, San Francisco, CA, USA.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Hejlawy', 'Affiliation': 'Department of Endodontics, University of the Pacific, Arthur A. Dugoni School of Dentistry, San Francisco, CA, USA.'}]",European endodontic journal,['10.14744/eej.2021.07088']
1542,34972765,"New chemotherapy regimens and biomarkers for Chagas disease: the rationale and design of the TESEO study, an open-label, randomised, prospective, phase-2 clinical trial in the Plurinational State of Bolivia.","INTRODUCTION


Chagas disease (CD) affects ~7 million people worldwide. Benznidazole (BZN) and nifurtimox (NFX) are the only approved drugs for CD chemotherapy. Although both drugs are highly effective in acute and paediatric infections, their efficacy in adults with chronic CD (CCD) is lower and variable. Moreover, the high incidence of adverse events (AEs) with both drugs has hampered their widespread use. Trials in CCD adults showed that quantitative PCR (qPCR) assays remain negative for 12 months after standard-of-care (SoC) BZN treatment in ~80% patients. BZN pharmacokinetic data and the nonsynchronous nature of the proliferative mammal-dwelling parasite stage suggested that a lower BZN/NFX dosing frequency, combined with standard or extended treatment duration, might have the same or better efficacy than either drug SoC, with fewer AEs.
METHODS AND ANALYSIS


New ThErapies and Biomarkers for ChagaS infEctiOn (TESEO) is an open-label, randomised, prospective, phase-2 clinical trial, with six treatment arms (75 patients/arm, 450 patients). Primary objectives are to compare the safety and efficacy of two new proposed chemotherapy regimens of BZN and NFX in adults with CCD with the current SoC for BZN and NFX, evaluated by qPCR and biomarkers for 36 months posttreatment and correlated with CD conventional serology. Recruitment of patients was initiated on 18 December 2019 and on 20 May 2021, 450 patients (study goal) were randomised among the six treatment arms. The treatment phase was finalised on 18 August 2021. Secondary objectives include evaluation of population pharmacokinetics of both drugs in all treatment arms, the incidence of AEs, and parasite genotyping.
ETHICS AND DISSEMINATION


The TESEO study was approved by the National Institutes of Health (NIH), U.S. Food and Drug Administration (FDA), federal regulatory agency of the Plurinational State of Bolivia and the Ethics Committees of the participating institutions. The results will be disseminated via publications in peer-reviewed journals, conferences and reports to the NIH, FDA and participating institutions.
TRIAL REGISTRATION NUMBER


NCT03981523.",2021,Trials in CCD adults showed that quantitative PCR (qPCR) assays remain negative for 12 months after standard-of-care (SoC) BZN treatment in ~80% patients.,"['patients was initiated on 18 December 2019 and on 20 May 2021, 450 patients (study goal', 'adults with chronic CD (CCD', 'Chagas disease', 'adults with CCD with the current SoC for BZN and NFX', '75 patients/arm, 450 patients']","['Benznidazole', 'BZN and NFX']","['quantitative PCR (qPCR) assays remain negative', 'evaluation of population pharmacokinetics of both drugs', 'incidence of AEs, and parasite genotyping', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0343804', 'cui_str': ""Chronic Chagas' disease""}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0041234', 'cui_str': 'Infection by Trypanosoma cruzi'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0053230', 'cui_str': 'benznidazole'}, {'cui': 'C0028073', 'cui_str': 'Nifurtimox'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0053230', 'cui_str': 'benznidazole'}, {'cui': 'C0028073', 'cui_str': 'Nifurtimox'}]","[{'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.122463,Trials in CCD adults showed that quantitative PCR (qPCR) assays remain negative for 12 months after standard-of-care (SoC) BZN treatment in ~80% patients.,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Alonso-Vega', 'Affiliation': 'Barcelona Institute for Global Health (ISGLOBAL), Barcelona, Spain.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Urbina', 'Affiliation': 'Center for Biochemistry and Biophysics, Venezuelan Institute for Scientific Research (IVIC), Caracas, Distrito Capital, Venezuela, Bolivarian Republic of.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Sanz', 'Affiliation': 'Biostatistics and Data Management Unit, Barcelona Institute for Global Health, Barcelona, Spain.'}, {'ForeName': 'María-Jesús', 'Initials': 'MJ', 'LastName': 'Pinazo', 'Affiliation': 'Barcelona Institute for Global Health (ISGLOBAL), Barcelona, Spain.'}, {'ForeName': 'Jimy José', 'Initials': 'JJ', 'LastName': 'Pinto', 'Affiliation': 'Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES), Cochabamba, Bolivia, Plurinational State of.'}, {'ForeName': 'Virginia R', 'Initials': 'VR', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Biological Sciences, The University of Texas at El Paso, El Paso, Texas, USA.'}, {'ForeName': 'Gimena', 'Initials': 'G', 'LastName': 'Rojas', 'Affiliation': 'Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES), Cochabamba, Bolivia, Plurinational State of.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Ortiz', 'Affiliation': 'Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES), Tarija, Bolivia, Plurinational State of.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Garcia', 'Affiliation': 'Centro Plataforma Chagas Sucre, Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES), Sucre, Bolivia, Plurinational State of.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lozano', 'Affiliation': 'Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES), Cochabamba, Bolivia, Plurinational State of.'}, {'ForeName': 'Dolors', 'Initials': 'D', 'LastName': 'Soy', 'Affiliation': 'Pharmacy Service, Division of Medicines, Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Rosa A', 'Initials': 'RA', 'LastName': 'Maldonado', 'Affiliation': 'Department of Biological Sciences, The University of Texas at El Paso, El Paso, Texas, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Nagarkatti', 'Affiliation': 'Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Debrabant', 'Affiliation': 'Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Schijman', 'Affiliation': 'Laboratorio de Biología Molecular de la Enfermedad de Chagas, Instituto de Investigaciones en Ingeniería Genética y Biología Molecular, Buenos Aires, Argentina.'}, {'ForeName': 'M Carmen', 'Initials': 'MC', 'LastName': 'Thomas', 'Affiliation': 'Consejo Superior de Investigaciones Científicas, Instituto de Parasitología y Biomedicina López-Neyra, Granada, Spain.'}, {'ForeName': 'Manuel Carlos', 'Initials': 'MC', 'LastName': 'López', 'Affiliation': 'Consejo Superior de Investigaciones Científicas, Instituto de Parasitología y Biomedicina López-Neyra, Granada, Spain.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Michael', 'Affiliation': 'Department of Chemistry and Biochemistry, The University of Texas at El Paso, El Paso, Texas, USA.'}, {'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Ribeiro', 'Affiliation': 'Dynamic Portfolio Unit, Drugs for Neglected Diseases initiative, Geneva, Switzerland.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Gascon', 'Affiliation': 'Barcelona Institute for Global Health (ISGLOBAL), Barcelona, Spain.'}, {'ForeName': 'Faustino', 'Initials': 'F', 'LastName': 'Torrico', 'Affiliation': 'Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES), Cochabamba, Bolivia, Plurinational State of.'}, {'ForeName': 'Igor C', 'Initials': 'IC', 'LastName': 'Almeida', 'Affiliation': 'Department of Biological Sciences, The University of Texas at El Paso, El Paso, Texas, USA icalmeida@utep.edu.'}]",BMJ open,['10.1136/bmjopen-2021-052897']
1543,34862359,A Pilot Randomized Controlled Trial of Intermittent Theta Burst Stimulation as Stand-Alone Treatment for Post-Stroke Aphasia: Effects on Language and Verbal Functional Magnetic Resonance Imaging (fMRI).,"BACKGROUND There is an ongoing need for facilitating language recovery in chronic post-stroke aphasia. The primary aim of this study (NCT01512264) was to examine if noninvasive intermittent theta burst stimulation (iTBS) applied to the injured left-hemispheric cortex promotes language improvements and fMRI changes in post-stroke aphasia. MATERIAL AND METHODS Participants were randomized to 3 weeks of sham (Tx0) or 1-3 weeks of iTBS (Tx123). We assessed participants who completed the first 2 functional MRI (fMRI) sessions (T1, T2) where they performed 2 overt language fMRI tasks, and examined longitudinal response after 3 months (T3). Language performance and fMRI activation changes, and relationships between these changes were assessed. RESULTS From T1 to T2, both groups showed improvements on the Boston Naming Test (BNT). From T1 to T3, Tx123 improved on the Aphasia Quotient, post-scan word recognition on the verbal paired associates task (VPAT), and perceived communicative ability. Each group exhibited significant activation changes between T1 and T2 for both tasks. Only the Tx123 group exhibited fMRI activation changes between T2 to T3 on the verb-generation task and between T1 and T3 on VPAT. Delayed aphasia symptom improvement for Tx123 was associated with increased left ventral visual stream activation from T1 to T3 (rho=0.74, P=0.0058), and with decreased bilateral supplementary motor area activation related to VPAT encoding from T2 to T3 (rho=-0.80, P=0.0016). CONCLUSIONS Observed iTBS-induced language improvements and associations between delayed fMRI changes and aphasia improvements support the therapeutic and neurorehabilitative potential of iTBS in post-stroke aphasia recovery.",2021,"Delayed aphasia symptom improvement for Tx123 was associated with increased left ventral visual stream activation from T1 to T3 (rho=0.74, P=0.0058), and with decreased bilateral supplementary motor area activation related to VPAT encoding from T2 to T3 (rho=-0.80, P=0.0016).",['Post-Stroke Aphasia'],"['Language and Verbal Functional Magnetic Resonance Imaging (fMRI', 'noninvasive intermittent theta burst stimulation (iTBS', 'Intermittent Theta Burst Stimulation']","['left ventral visual stream activation', 'fMRI activation changes', 'Aphasia Quotient, post-scan word recognition on the verbal paired associates task (VPAT), and perceived communicative ability', 'Language performance and fMRI activation changes', 'Boston Naming Test (BNT', 'activation changes', 'Delayed aphasia symptom improvement']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0442540', 'cui_str': 'Stream'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0451037', 'cui_str': 'Boston naming test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.222375,"Delayed aphasia symptom improvement for Tx123 was associated with increased left ventral visual stream activation from T1 to T3 (rho=0.74, P=0.0058), and with decreased bilateral supplementary motor area activation related to VPAT encoding from T2 to T3 (rho=-0.80, P=0.0016).","[{'ForeName': 'Jane B', 'Initials': 'JB', 'LastName': 'Allendorfer', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Nenert', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Vannest', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Jerzy P', 'Initials': 'JP', 'LastName': 'Szaflarski', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.934818']
1544,34875413,History of respiratory problems in prior infant and respiratory morbidity in subsequent pregnancy.,"OBJECTIVE


Respiratory distress syndrome (RDS) is a common cause of morbidity in preterm neonates. Late preterm births (34 0/7 to 36 6/7 weeks of gestation) account for three-quarters of preterm births. Delivery in the late preterm period is a well-established risk factor for RDS. 1  Whether history of a neonate with respiratory morbidity at birth relates to respiratory morbidity in a subsequent pregnancy is not well characterized. In this research letter, we have described how maternally reported respiratory morbidity in a neonate in a previous pregnancy is associated with respiratory morbidity in a neonate in a subsequent pregnancy.
STUDY DESIGN


This was a secondary analysis of a randomized controlled study of antenatal corticosteroids in the late preterm period (antenatal betamethasone for women at risk for late preterm delivery). 2  Multiparous patients with a singleton pregnancy were included. The institutional review board at The University of Chicago (approval number IRB 21-0141) deemed this study exempt. Respiratory morbidity of a previous infant was maternally reported in a questionnaire specifying any ""respiratory problems at birth"" in their live neonates (yes or no). Major respiratory morbidity (MRM) in the current pregnancy was defined as any of the following: continuous positive airway pressure or high-flow nasal cannula for ≥12 hours in the first 72 hours of life, ventilator use in the first 72 hours of life, extracorporeal membrane oxygenation, oxygen requirement of FiO2 of ≥0.3 for ≥24 total hours in the first 72 hours of life, or stillbirth or neonatal death at <72 hours of age. This was abstracted from maternal and neonatal medical records. The presence of any respiratory morbidity (MRM, RDS, or transient tachypnea of the newborn [TTN]) was compared by history of a previous infant with any respiratory morbidity. Chi-square and Wilcoxon rank-sum tests were used for bivariable analyses, and logistic regression was performed to adjust for confounders. The analysis was repeated, stratified by any betamethasone use.
RESULTS


We included 1412 multiparous patients, 195 with a previous infant with maternally reported respiratory morbidity and 1217 without. RDS, MRM, and a composite of RDS, TTN, and apnea were more likely among those who had a sibling with respiratory morbidity, per maternal report (adjusted odds ratio [aOR] of RDS, 2.17 [95% confidence interval (CI), 1.28-3.70]; aOR of MRM, 1.9 [95% CI, 1.20-3.02]; aOR of RDS, TTN, and apnea, 1.85 [95% CI, 1.22-2.70]). When stratified by administration of betamethasone, the risk of MRM was only persistent in those without betamethasone use (aOR, 1.84; 95% CI, 1.00-3.39). Similarly, the risk of RDS and a composite risk of RDS, TTN, and apnea were only persistent in those without betamethasone use (aOR, 2.37 [95% CI, 1.16-4.84]; aOR, 1.82 [95% CI, 1.05-3.17]) Tables 1 and 2.
CONCLUSION


A maternally reported history of respiratory morbidity in a previous late preterm or term infant was independently associated with respiratory morbidity, including RDS, in a subsequent infant. When stratified by betamethasone use, the risk of respiratory morbidity was only persistent in those neonates without betamethasone exposure during the late preterm period.",2022,"A maternally reported history of respiratory morbidity in a previous late preterm or term infant was independently associated with respiratory morbidity, including RDS, in a subsequent infant.","['preterm neonates', '1412 multiparous patients, 195 with a previous infant with maternally reported respiratory morbidity and 1217 without', '2  Multiparous patients with a singleton pregnancy', 'women at risk for late preterm delivery']","['betamethasone', 'antenatal corticosteroids']","['RDS, MRM, and a composite of RDS, TTN, and apnea', 'Respiratory morbidity', 'risk of respiratory morbidity', 'life, or stillbirth or neonatal death', 'Late preterm births', 'respiratory morbidity (MRM, RDS, or transient tachypnea of the newborn [TTN', 'risk of RDS and a composite risk of RDS, TTN, and apnea', 'Major respiratory morbidity (MRM', 'respiratory morbidity', 'risk of MRM']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0026751', 'cui_str': 'Multiparous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0158940', 'cui_str': 'Transitory tachypnea of newborn'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",1412.0,0.141189,"A maternally reported history of respiratory morbidity in a previous late preterm or term infant was independently associated with respiratory morbidity, including RDS, in a subsequent infant.","[{'ForeName': 'Naima', 'Initials': 'N', 'LastName': 'Ross', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The University of Chicago Medicine, 5841 S. Maryland Ave., MC 2050, Chicago, IL, 60637; Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The University of North Carolina at Chapel Hill, Chapel Hill, NC. Electronic address: naima.ross@uchospitals.edu.'}, {'ForeName': 'Sunitha C', 'Initials': 'SC', 'LastName': 'Suresh', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The University of Chicago Medicine, 5841 S. Maryland Ave., MC 2050, Chicago, IL, 60637; Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Dude', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The University of Chicago Medicine, 5841 S. Maryland Ave., MC 2050, Chicago, IL, 60637; Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The University of North Carolina at Chapel Hill, Chapel Hill, NC.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2021.100544']
1545,34896732,Impact of diaper change frequency on preterm infants' vital sign stability and skin health: A RCT.,"BACKGROUND


Bundling nurse caregiving interventions are promoted to minimize infant stress.
PURPOSE


To evaluate impact of bundled nursing care and diaper change frequency on vital sign stability and skin health of preterm infants born ≤32 weeks gestation.
METHOD


Stable preterm infants on a 3-hour feeding schedule were randomly assigned to 3- vs. 6-hour diaper changes. Diapers were changed prior to 6 h if stool was present. Direct observation of bundled care events (BCE) identify caregiving activities during each BCE. Skin pH, transepidermal water loss (TEWL), and neonatal skin condition scores (NSCS) were obtained. Vital sign data (HR, RR, O 2  saturation) was downloaded from bedside monitors.
RESULTS


Forty-six infants contributed to 605 BCEs. BCEs lasted on average 28 min and included nine different activities (e.g., vital signs, feeding). Significant increases in heart rate during BCEs occurred in approximately half of the observations. Among observations with a diaper change increases in heart rate during diapering occurred in over 74% of observations Infants who were awake at the beginning of BCEs had 48% lower odds of having a change in heart rate than infants who were sleeping (p = .02). There were no group differences (3- vs. 6-hour diaper change) in skin health outcomes (TEWL, pH, NSCS).
CONCLUSION


Reducing diaper change frequency without stool present should be considered to minimize caregiving stress in preterm infants. Additional research should evaluate the intrusiveness and clusters of activities that significantly impact physiologic stability to better individualize the timing of routine yet intrusive activities. Clinicaltrials.gov registry # NCT03370757.",2022,"There were no group differences (3- vs. 6-hour diaper change) in skin health outcomes (TEWL, pH, NSCS).
","['preterm infants', 'Stable preterm infants on a 3-hour feeding schedule', 'preterm infants born ≤32\xa0weeks gestation', 'Forty-six infants contributed to 605 BCEs']",['bundled nursing care and diaper change frequency'],"['vital sign stability and skin health', 'heart rate', 'Vital sign data (HR, RR, O 2  saturation', 'heart rate during BCEs', 'Skin pH, transepidermal water loss (TEWL), and neonatal skin condition scores (NSCS', 'skin health outcomes (TEWL, pH, NSCS']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0180416', 'cui_str': 'Diaper'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0232445', 'cui_str': 'Acid mantle'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1274236', 'cui_str': 'Neonatal dermatosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0313566,"There were no group differences (3- vs. 6-hour diaper change) in skin health outcomes (TEWL, pH, NSCS).
","[{'ForeName': 'Debra H', 'Initials': 'DH', 'LastName': 'Brandon', 'Affiliation': 'Duke University School of Nursing, DUMC 3322, 307 Trent Drive, Durham, NC 27710, United States of America; Duke University School of Medicine, Department of Pediatrics, Duke University Hospital, DUMC 2739, Durham, NC 27710, United States of America. Electronic address: debra.brandon@duke.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hatch', 'Affiliation': 'Duke University School of Nursing, DUMC 3322, 307 Trent Drive, Durham, NC 27710, United States of America. Electronic address: daniel.hatch@duke.edu.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Barnes', 'Affiliation': 'Duke University School of Nursing, DUMC 3322, 307 Trent Drive, Durham, NC 27710, United States of America. Electronic address: angel.barnes@duke.edu.'}, {'ForeName': 'Ashlee J', 'Initials': 'AJ', 'LastName': 'Vance', 'Affiliation': 'Duke University School of Nursing, DUMC 3322, 307 Trent Drive, Durham, NC 27710, United States of America. Electronic address: ashleev@med.umich.edu.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Harney', 'Affiliation': 'Duke University School of Nursing, DUMC 3322, 307 Trent Drive, Durham, NC 27710, United States of America. Electronic address: jane.harney@wisc.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Voigtman', 'Affiliation': 'Kimberly Clark Corporation South Office, 2001 Marathon Avenue, Neenah, WI 54956, United States of America. Electronic address: Barbara.Voigtman@kcc.com.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': 'Younge', 'Affiliation': 'Duke University School of Medicine, Department of Pediatrics, Duke University Hospital, DUMC 2739, Durham, NC 27710, United States of America. Electronic address: noelle.younge@duke.edu.'}]",Early human development,['10.1016/j.earlhumdev.2021.105510']
1546,34952877,How do people perceive different labels for rotator cuff disease? A content analysis of data collected in a randomised controlled experiment.,"OBJECTIVES


Explore how people perceive different labels for rotator cuff disease in terms of words or feelings evoked by the label and treatments they feel are needed.
SETTING


We performed a content analysis of qualitative data collected in a six-arm, online randomised controlled experiment.
PARTICIPANTS


1308 people with and without shoulder pain read a vignette describing a patient with rotator cuff disease and were randomised to one of six labels:  subacromial impingement syndrome, rotator cuff tear, bursitis, rotator-cuff-related shoulder pain, shoulder sprain  and  episode of shoulder pain .
PRIMARY AND SECONDARY OUTCOMES


Participants answered two questions (free-text response) about: (1) words or feelings evoked by the label; (2) what treatments they feel are needed. Two researchers iteratively developed coding frameworks to analyse responses. Results 1308/1626 (80%) complete responses for each question were analysed. Psychological distress (21%), uncertainty (22%), serious condition (15%) and poor prognosis (9%) were most often expressed by those labelled with  subacromial impingement syndrome . For those labelled with a  rotator cuff tear,  psychological distress (13%), serious condition (9%) and poor prognosis (8%) were relatively common, while minor issue was expressed least often compared with the other labels (5%). Treatment/investigation and surgery were common among those labelled with a  rotator cuff tear  (11% and 19%, respectively) and  subacromial impingement syndrome  (9% and 10%) compared with  bursitis  (7% and 5%).
CONCLUSIONS


Words or feelings evoked by certain labels for rotator cuff disease and perceived treatment needs may explain why some labels drive management preferences towards surgery and imaging more than others.",2021,"Treatment/investigation and surgery were common among those labelled with a  rotator cuff tear  (11% and 19%, respectively) and  subacromial impingement syndrome  (9% and 10%) compared with  bursitis  (7% and 5%).
",['1308 people with and without shoulder pain read a vignette describing a patient with rotator cuff disease'],"['six labels:  subacromial impingement syndrome, rotator cuff tear, bursitis, rotator-cuff-related shoulder pain, shoulder sprain  and  episode of shoulder pain ']","['serious condition', 'Psychological distress', 'subacromial impingement syndrome', 'psychological distress']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0006444', 'cui_str': 'Bursitis'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0272869', 'cui_str': 'Sprain of shoulder'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}]",1308.0,0.130215,"Treatment/investigation and surgery were common among those labelled with a  rotator cuff tear  (11% and 19%, respectively) and  subacromial impingement syndrome  (9% and 10%) compared with  bursitis  (7% and 5%).
","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Zadro', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, The University of Sydney and Sydney Local Health District, Camperdown, New South Wales, Australia joshua.zadro@sydney.edu.au.'}, {'ForeName': 'Zoe A', 'Initials': 'ZA', 'LastName': 'Michaleff', 'Affiliation': 'Faculty of Health Sciences and Medicine, Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""O'Keeffe"", 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, The University of Sydney and Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Giovanni E', 'Initials': 'GE', 'LastName': 'Ferreira', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, The University of Sydney and Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Romi', 'Initials': 'R', 'LastName': 'Haas', 'Affiliation': 'Monash Department of Clinical Epidemiology, Cabrini Institute, Monash University, Malvern, Victoria, Australia.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Harris', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, The University of Sydney and Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Buchbinder', 'Affiliation': 'Monash Department of Clinical Epidemiology, Cabrini Institute, Monash University, Malvern, Victoria, Australia.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, The University of Sydney and Sydney Local Health District, Camperdown, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2021-052092']
1547,34954651,Feasibility of a theory-informed mobile app for changing physical activity in youth with multiple sclerosis.,"BACKGROUND


Youth with multiple sclerosis (MS) have high levels of disease activity, depression and fatigue, and lower moderate to vigorous physical activity (PA). PA participation is associated with lower disease activity, depression and fatigue as well as higher self-efficacy, goal setting and decreased barriers. These latter constructs may be targeted by an intervention program for behavior change, and such intervention must account for disease rarity, geographical proximity and time constraints which limit the feasibility, accessibility, and sustainability of implementing a PA intervention in youth with MS. We have developed a theory-informed mobile-app based PA promotion program to address these barriers, Active Teens with Multiple Sclerosis (ATOMIC) and herein report the feasibility of delivering this intervention in youth with MS.
OBJECTIVE


To determine the feasibility of delivering the ATOMIC program to youth with MS.
METHODS


Fifteen youth with MS (13F, 16.6 ± 1.2 years) followed at the Hospital for Sick Children were enrolled in the ATOMIC intervention. Participants underwent a standard clinical evaluation; an exercise test to determine cardiorespiratory fitness; 7-day PA monitoring with an accelerometer; and completed standardized depression, fatigue questionnaires at baseline and post-intervention. Social cognitive scales related to self-efficacy, self-management, goal setting, perceived barriers, outcome expectancy, and social support were completed at baseline, six and 12-weeks. The 12-week mobile app PA intervention was informed by Social Cognitive Theory (SCT) and included: individualized PA coaching, PA self-monitoring (Fitbit), goal setting, social support and MS specific educational modules. Feasibility was defined as (1) meeting the recruitment target of 15 participants within a one-year period; (2) completion of ≥80% of study related questionnaires and testing; (3) a drop-out rate of less than 20%, and (4) adherence to the ATOMIC intervention program components of ≥80% (Fitbit wear, PA coaching calls, modules).
RESULTS


From March 2018 to April 2019, 53% of youth approached agreed to participate (15/28). 13/15 participants completed the intervention. 36 of the possible 39 coaching calls (92%: 3 possible phone calls per participant); 89% wear adherence to Fitbit Charge2  data (mean = 75 ± 16.6 days of 84 days); and 5/12 (42%) of modules were completed. An average 8.4% (SD= 40%, range = -74.0 to 176%) increase in Fitbit steps above the first week of the intervention were observed. PA level from accelerometry at 12-weeks, aerobic fitness, depression and fatigue were unchanged. SCT scales indicated an increase in social support from friends (0.67-points, T = 2.7, pholm=0.04), and a decrease in outcome expectancy (-2.7, T = 3.0, pholm=0.03). There were no differences in self-efficacy, self-management or perceived barriers post intervention.
CONCLUSIONS


Our results indicate that the ATOMIC program is feasible for delivery in youth with MS. Future work is needed to understand how to best implement each element of SCT through added features in the mobile-app, and to evaluate how the individual components of SCT mediate change in PA behaviours of youth with MS.",2022,"PA participation is associated with lower disease activity, depression and fatigue as well as higher self-efficacy, goal setting and decreased barriers.","['Youth with multiple sclerosis (MS', 'Fifteen youth with MS (13F, 16.6\u202f±\u202f1.2 years) followed at the Hospital for Sick Children', '13/15 participants completed the intervention', 'youth with multiple sclerosis']","['standard clinical evaluation; an exercise test to determine cardiorespiratory fitness; 7-day PA monitoring with an accelerometer; and completed standardized depression, fatigue questionnaires at baseline and post-intervention', 'Fitbit Charge2', 'theory-informed mobile app', 'mobile app PA intervention was informed by Social Cognitive Theory (SCT) and included: individualized PA coaching, PA self-monitoring (Fitbit), goal setting, social support and MS specific educational modules']","['social support', 'SCT scales', 'Fitbit steps', 'self-efficacy, self-management or perceived barriers post intervention', 'outcome expectancy', 'Social cognitive scales related to self-efficacy, self-management, goal setting, perceived barriers, outcome expectancy, and social support', 'PA level from accelerometry at 12-weeks, aerobic fitness, depression and fatigue']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0260101', 'cui_str': 'Sick child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C1998726', 'cui_str': 'Is informed'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",15.0,0.0129702,"PA participation is associated with lower disease activity, depression and fatigue as well as higher self-efficacy, goal setting and decreased barriers.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stephens', 'Affiliation': 'Division of Neurology, Department of Pediatrics, The Hospital for Sick Children, Division of Neurosciences and Mental Health, SickKids Research Institute, Toronto, ON, Canada. Electronic address: Samantha.stephens@sickkids.ca.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Schneiderman', 'Affiliation': 'Clinical Research Services, Hospital for Sick Children, Toronto, Ontario, Canada; Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, Ontario, Canada. Electronic address: Jane.schneiderman@sickkids.ca.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Finlayson', 'Affiliation': ""Faculty of Health Sciences, Queen's University, Kingston, ON, Canada. Electronic address: marcia.finlayson@queensu.ca.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Berenbaum', 'Affiliation': 'Division of Neurology, Department of Pediatrics, The Hospital for Sick Children, Division of Neurosciences and Mental Health, SickKids Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Chicago Illinois, Chicago, IL, USA. Electronic address: robmotl@uic.edu.'}, {'ForeName': 'E Ann', 'Initials': 'EA', 'LastName': 'Yeh', 'Affiliation': 'Division of Neurology, Department of Pediatrics, The Hospital for Sick Children, Division of Neurosciences and Mental Health, SickKids Research Institute, Toronto, ON, Canada; Faculty of Medicine, Department of Pediatrics, University of Toronto, Toronto, ON, Canada. Electronic address: ann.yeh@sickkids.ca.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.103467']
1548,34954406,"The Effects of Aroma Essential Oil Inhalation on Stress, Pain, and Sleep Quality in Laparoscopic Cholecystectomy Patients: A Randomized Controlled Trial.","PURPOSE


Patients undergoing cholecystectomy report experiencing stress related to the surgery, complaining of pain and poor sleep quality. Aromatherapy is known to have positive effects on these complaints. However, the effect of aromatherapy on cholecystectomy patients has yet to be determined. The aim of this study, therefore, was to investigate the effects of aromatherapy on laparoscopic cholecystectomy patients' stress, pain, and sleep quality.
METHODS


This study was a randomized controlled trial involving 69 adults who underwent laparoscopic cholecystectomy. Essential oil therapy was given to an intervention group, and almond oil was given to a placebo group. The outcome variables were stress, pain, and sleep quality.
RESULTS


There were no differences between the groups in terms of demographic and clinical characteristics and pretreatment dependent variables. After the intervention, subjective stress (F = 7.43, p < .001), objective stress (F = 2.70, p = .034), parasympathetic nerve activity (F = 2.65, p = .036), pain (F = 8.74, p < .001), analgesics administration (F = 22.43, p < .001), and sleep quality (F = 5.23, p < .001) were significantly different between the intervention, placebo, and control groups. Sympathetic nerve activity was not significantly different. The effect sizes regarding the sleep quality of the intervention versus control group and the intervention versus placebo group were 1.92 and 1.52, respectively.
CONCLUSION


Postoperative aromatherapy received by cholecystectomy patients was effective in reducing stress and pain and improving sleep quality. No side effects of aromatherapy were reported during the experimental treatment.",2022,"The effect sizes regarding the sleep quality of the intervention vs control group and the intervention vs placebo group were 1.92 and 1.52, respectively.
","['Patients undergoing cholecystectomy report experiencing stress related to the surgery, complaining of pain and poor sleep quality', 'Laparoscopic Cholecystectomy Patients', 'laparoscopic cholecystectomy patients', '69 adults who underwent']","['placebo', 'Aromatherapy', 'Aroma Essential Oil Inhalation', 'laparoscopic cholecystectomy', 'Essential oil therapy', 'Postoperative aromatherapy', 'aromatherapy']","['pain', 'analgesics administration', 'parasympathetic nerve activity', 'stress and pain and improving sleep quality', 'sleep quality', 'objective stress', 'Sympathetic nerve activity', 'stress, pain, and sleep quality', 'subjective stress', 'Stress, Pain, and Sleep Quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C2987717', 'cui_str': 'Scents'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic'}, {'cui': 'C0459522', 'cui_str': 'Parasympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",69.0,0.0510454,"The effect sizes regarding the sleep quality of the intervention vs control group and the intervention vs placebo group were 1.92 and 1.52, respectively.
","[{'ForeName': 'JiA', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Gyeongbuk College of Health, Gimcheon, Republic of Korea.'}, {'ForeName': 'Myung-Haeng', 'Initials': 'MH', 'LastName': 'Hur', 'Affiliation': 'College of Nursing, Eulji University, Uijeongbu, Republic of Korea. Electronic address: wowmhhur@nate.com.'}]",Asian nursing research,['10.1016/j.anr.2021.11.002']
1549,34957531,Using Data on Survival with Idiopathic Pulmonary Fibrosis to Estimate Survival with Other Types of Progressive Fibrosis Interstitial Lung Disease: A Bayesian Framework.,"INTRODUCTION


Among the various types of progressive fibrosing interstitial lung diseases (PF-ILDs), substantial survival data exist for idiopathic pulmonary fibrosis (IPF) but not for other types. This hinders evidence-based decisions about treatment and management, as well as the economic modelling needed to justify research into new treatments and reimbursement approvals. Given the clinical similarities between IPF and other PF-ILDs, we reasoned that patient survival data from four major IPF trials could be used to estimate long-term survival in other PF-ILDs.
METHODS


We used propensity score matching to match patients with IPF taking either nintedanib or placebo in the TOMORROW, INPULSIS-1, INPULSIS-2 and INPULSIS-ON trials to patients with PF-ILDs other than IPF in the INBUILD trial. Seven models were fitted to the survival data for the matched patients with IPF, and the three best-fitting models were used to generate informative priors in a Bayesian framework to extrapolate patient survival of the INBUILD population.
RESULTS


After propensity score matching, the analysis included data from 1099 patients with IPF (640 nintedanib patients; 459 placebo patients) and 654 patients with other PF-ILDs (326 nintedanib patients; 328 placebo patients). Gamma, log-logistic and Weibull models best fit the survival of the matched patients with IPF. All three models led to consistent Bayesian estimates of survival for the matched patients with other PF-ILDs, with median rates of overall survival ranging from 6.34 to 6.50 years after starting nintedanib. The corresponding control group survival estimates were 3.42 to 3.76 years.
CONCLUSION


We provide the first estimates of long-term overall survival for patients with PF-ILDs other than IPF, and our analysis suggests that nintedanib may prolong their survival. Our Bayesian approach to estimating survival of one disease based on clinical trial data from a similar disease may help inform economic modelling of rare, orphan and newly defined disorders.",2022,"All three models led to consistent Bayesian estimates of survival for the matched patients with other PF-ILDs, with median rates of overall survival ranging from 6.34 to 6.50 years after starting nintedanib.",['1099 patients with IPF (640 nintedanib patients; 459 placebo patients) and 654 patients with other PF-ILDs (326 nintedanib patients; 328 placebo patients'],['nintedanib or placebo'],"['median rates of overall survival', 'survival estimates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C5191353', 'cui_str': '326'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",7.0,0.189684,"All three models led to consistent Bayesian estimates of survival for the matched patients with other PF-ILDs, with median rates of overall survival ranging from 6.34 to 6.50 years after starting nintedanib.","[{'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Langford', 'Affiliation': 'Symmetron Limited, 8 Devonshire Square, London, EC2M 4PL, UK. blangford@symmetron.net.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Diamantopoulos', 'Affiliation': 'Symmetron Limited, 8 Devonshire Square, London, EC2M 4PL, UK.'}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'Hastings Center for Pulmonary Research and Division of Pulmonary, Critical Care and Sleep Medicine, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.'}, {'ForeName': 'Klaus B', 'Initials': 'KB', 'LastName': 'Rohr', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baldwin', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}]",Advances in therapy,['10.1007/s12325-021-02014-z']
1550,34957859,Metformin improves skeletal muscle microvascular insulin resistance in metabolic syndrome.,"Microvascular insulin resistance is present in metabolic syndrome and may contribute to increased cardiovascular disease risk and the impaired metabolic response to insulin observed. Metformin improves metabolic insulin resistance in humans. Its effects on macro and microvascular insulin resistance have not been defined. Eleven subjects with nondiabetic metabolic syndrome were studied four times (before and after 12 wk of treatment with placebo or metformin) using a crossover design, with an 8-wk washout interval between treatments. On each occasion, we measured three indices of large artery function [pulse wave velocity (PWV), radial pulse wave separation analysis (PWSA), brachial artery endothelial function (flow-mediated dilation-FMD)] as well as muscle microvascular perfusion [contrast-enhanced ultrasound (CEU)] before and at 120 min into a 150 min, 1 mU/min/kg euglycemic insulin clamp. Metformin decreased body mass index (BMI), fat weight, and % body fat ( P  < 0.05, each), however, placebo had no effect. Metformin (not placebo) improved metabolic insulin sensitivity, (clamp glucose infusion rate,  P  < 0.01), PWV, and FMD after insulin were unaffected by metformin treatment. PWSA improved with insulin only after metformin  P  < 0.01). Insulin decreased muscle microvascular blood volume measured by contrast ultrasound both before and after placebo and before metformin ( P  < 0.02 for each) but not after metformin. Short-term metformin treatment improves both metabolic and muscle microvascular response to insulin. Metformin's effect on microvascular insulin responsiveness may contribute to its beneficial metabolic effects. Metformin did not improve aortic stiffness or brachial artery endothelial function, but enhanced radial pulse wave properties consistent with relaxation of smaller arterioles. NEW & NOTEWORTHY  Metformin, a first-line treatment for type 2 diabetes, is often used in patients with insulin resistance and metabolic syndrome. Here, we provide the first evidence for metformin improving muscle microvascular insulin sensitivity in insulin-resistant humans. Simultaneously, metformin improved muscle glucose disposal, supporting a close relationship between insulin's microvascular and its metabolic actions in muscle. Whether enhanced microvascular insulin sensitivity contributes to metformin's ability to decrease microvascular complications in diabetes remains to be resolved.",2022,"RESULTS


Metformin decreased body mass index (BMI), fat weight, and % body fat (P<0.05, each), placebo had no effect.","['Eleven non-diabetic, metabolic syndrome subjects', 'Metabolic Syndrome', 'humans']","['placebo', 'placebo or metformin', 'metformin', 'Metformin', 'Metformin (not placebo']","['body mass index (BMI), fat weight, and % body fat', 'Skeletal Muscle Microvascular Insulin Resistance', 'PWSA', 'muscle microvascular blood volume', 'metabolic and muscle microvascular response', 'microvascular insulin responsiveness', 'metabolic insulin resistance', 'large artery function (pulse wave velocity-PWV, radial pulse wave separation analysis (PWSA), brachial artery endothelial function (flow-mediated dilation-FMD) as well as muscle microvascular perfusion (contrast-enhanced ultrasound-CEU', 'PWV, and FMD after insulin', 'metabolic insulin sensitivity, (clamp glucose infusion rate, P<0.01', 'aortic stiffness or brachial artery endothelial function']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0226003', 'cui_str': 'Structure of large artery'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0232142', 'cui_str': 'Radial pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}]",,0.0832758,"RESULTS


Metformin decreased body mass index (BMI), fat weight, and % body fat (P<0.05, each), placebo had no effect.","[{'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Jahn', 'Affiliation': 'Division of Endocrinology, Department of Medicine, University of Virginia, School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Hartline', 'Affiliation': 'Division of Endocrinology, Department of Medicine, University of Virginia, School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Zhenqi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Division of Endocrinology, Department of Medicine, University of Virginia, School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Eugene J', 'Initials': 'EJ', 'LastName': 'Barrett', 'Affiliation': 'Division of Endocrinology, Department of Medicine, University of Virginia, School of Medicine, Charlottesville, Virginia.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00287.2021']
1551,34958013,Repetitive Transcranial Magnetic Stimulation as a Treatment for Veterans with Cognitive Impairment and Multiple Comorbidities.,"BACKGROUND


Despite decades of research efforts, current treatments for Alzheimer's disease (AD) are of limited effectiveness and do not halt the progression of the disease and associated cognitive decline. Studies have shown that repetitive transcranial magnetic stimulation (rTMS) may improve cognition.
OBJECTIVE


We conducted a pilot study to investigate the effect of rTMS on cognitive function in Veterans with numerous medical comorbidities.
METHODS


Participants underwent 20 sessions, over the course of approximately 4 weeks, of 10 Hz rTMS at the left dorsolateral prefrontal cortex with intensity of 120% resting motor threshold. Outcome measures including memory, language, verbal fluency, and executive functions were acquired at baseline, end of treatment, and 4 months after the last rTMS session. Twenty-six Veterans completed the study (13 in the active rTMS group, 13 in the sham rTMS group).
RESULTS


The study protocol was well-tolerated. Active, compared to sham, rTMS showed improved auditory-verbal memory at the end of treatment and at 4-month follow-up. However, the active rTMS group demonstrated a trend in decreased semantic verbal fluency at the end of treatment and at 4-month follow up.
CONCLUSION


These preliminary results show rTMS is safe in general in this elderly Veteran population with multiple co-morbidities. Patients in the sham group showed an expected, slight decline in the California Verbal Learning Test scores over the course of the study, whereas the active treatment group showed a slight improvement at the 4-month post-treatment follow up. These effects need to be confirmed by studies of larger sample sizes.",2022,"Active, compared to sham, rTMS showed improved auditory-verbal memory at the end of treatment and at 4-month follow-up.","['elderly Veteran population with multiple co-morbidities', ""Alzheimer's disease (AD"", 'Veterans with numerous medical comorbidities', 'Twenty-six Veterans completed the study (13 in the active rTMS group, 13 in the sham rTMS group', 'Veterans with Cognitive Impairment and Multiple Comorbidities']","['repetitive transcranial magnetic stimulation (rTMS', 'rTMS', '10 Hz rTMS', 'Repetitive Transcranial Magnetic Stimulation']","['auditory-verbal memory', 'California Verbal Learning Test scores', 'tolerated', 'memory, language, verbal fluency, and executive functions', 'cognitive function', 'semantic verbal fluency']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}]",,0.0518312,"Active, compared to sham, rTMS showed improved auditory-verbal memory at the end of treatment and at 4-month follow-up.","[{'ForeName': 'Jauhtai', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'J Kaci', 'Initials': 'JK', 'LastName': 'Fairchild', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'M Windy', 'Initials': 'MW', 'LastName': 'McNerney', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Art', 'Initials': 'A', 'LastName': 'Noda', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'J Wesson', 'Initials': 'JW', 'LastName': 'Ashford', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Steven Z', 'Initials': 'SZ', 'LastName': 'Chao', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Allyson C', 'Initials': 'AC', 'LastName': 'Rosen', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Durazzo', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Lazzeroni', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Yesavage', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-210349']
1552,34876434,"Study protocol: Minimum effective low dose: anti-human thymocyte globulin (MELD-ATG): phase II, dose ranging, efficacy study of antithymocyte globulin (ATG) within 6 weeks of diagnosis of type 1 diabetes.","INTRODUCTION


Type 1 diabetes (T1D) is a chronic autoimmune disease, characterised by progressive destruction of the insulin-producing β cells of the pancreas. One immunosuppressive agent that has recently shown promise in the treatment of new-onset T1D subjects aged 12-45 years is antithymocyte globulin (ATG), Thymoglobuline, encouraging further exploration in lower age groups.
METHODS AND ANALYSIS


Minimal effective low dose (MELD)-ATG is a phase 2, multicentre, randomised, double-blind, placebo-controlled, multiarm parallel-group trial in participants 5-25 years diagnosed with T1D within 3-9 weeks of planned treatment day 1. A total of 114 participants will be recruited sequentially into seven different cohorts with the first cohort of 30 participants being randomised to placebo, 2.5 mg/kg, 1.5 mg/kg, 0.5 mg/kg and 0.1 mg/kg ATG total dose in a 1:1:1:1:1 allocation ratio. The next six cohorts of 12-15 participants will be randomised to placebo, 2.5 mg/kg, and one or two selected middle ATG total doses in a 1:1:1:1 or 1:1:1 allocation ratio, as dependent on the number of middle doses, given intravenously over two consecutive days. The primary objective will be to determine the changes in stimulated C-peptide response over the first 2 hours of a mixed meal tolerance test at 12 months for 2.5 mg/kg ATG arm vs the placebo. Conditional on finding a significant difference at 2.5 mg/kg, a minimally effective dose will be sought. Secondary objectives include the determination of the effects of a particular ATG treatment dose on (1) stimulated C-peptide, (2) glycated haemoglobin, (3) daily insulin dose, (4) time in range by intermittent continuous glucose monitoring measures, (5) fasting and stimulated dry blood spot (DBS) C-peptide measurements.
ETHICS AND DISSEMINATION


MELD-ATG received first regulatory and ethical approvals in Belgium in September 2020 and from the German and UK regulators as of February 2021. The publication policy is set in the INNODIA (An innovative approach towards understanding and arresting Type 1 diabetes consortium) grant agreement (www.innodia.eu).
TRIAL REGISTRATION NUMBER


NCT03936634; Pre-results.",2021,"One immunosuppressive agent that has recently shown promise in the treatment of new-onset T1D subjects aged 12-45 years is antithymocyte globulin (ATG), Thymoglobuline, encouraging further exploration in lower age groups.
","['participants 5-25 years diagnosed with T1D within 3-9 weeks of planned treatment day 1', 'new-onset T1D subjects aged 12-45 years', '114 participants will be recruited sequentially into seven different cohorts with the first cohort of 30 participants being randomised to']","['placebo', ' anti-human thymocyte globulin (MELD-ATG', 'antithymocyte globulin (ATG']","['determination of the effects of a particular ATG treatment dose on (1) stimulated C-peptide, (2) glycated haemoglobin, (3) daily insulin dose, (4) time in range by intermittent continuous glucose monitoring measures, (5) fasting and stimulated dry blood spot (DBS) C-peptide measurements']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0814999', 'cui_str': 'Thymic lymphocyte'}, {'cui': 'C0017649', 'cui_str': 'Globulin'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}]","[{'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement'}]",114.0,0.528992,"One immunosuppressive agent that has recently shown promise in the treatment of new-onset T1D subjects aged 12-45 years is antithymocyte globulin (ATG), Thymoglobuline, encouraging further exploration in lower age groups.
","[{'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Wilhelm-Benartzi', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK Wilhelm-BenartziC@cardiff.ac.uk.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Miller', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Sylvaine', 'Initials': 'S', 'LastName': 'Bruggraber', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Picton', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Gatley', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Chhabra', 'Affiliation': 'Pharmacy, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'M Loredana', 'Initials': 'ML', 'LastName': 'Marcovecchio', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'A Emile J', 'Initials': 'AEJ', 'LastName': 'Hendriks', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Morobé', 'Affiliation': 'Katholieke Universiteit Leuven/ Universitaire Ziekenhuizen, Leuven, Belgium.'}, {'ForeName': 'Piotr Jaroslaw', 'Initials': 'PJ', 'LastName': 'Chmura', 'Affiliation': 'Center for Protein Research, Kobenhavns Universitet Sundhedsvidenskabelige Fakultet, Kobenhavn, Denmark.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Bärbel', 'Initials': 'B', 'LastName': 'Aschemeier-Fuchs', 'Affiliation': ""Diabetes Centre for Children and Adolescents, Children's Hospital Auf der Bult, Hannover, Germany.""}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knip', 'Affiliation': 'Research Program for Clinical and Molecular Metabolism, University of Helsinki Faculty of Medicine, Helsinki, Finland.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Tree', 'Affiliation': ""Department of Immunobiology, King's College London, London, UK.""}, {'ForeName': 'Lut', 'Initials': 'L', 'LastName': 'Overbergh', 'Affiliation': 'Katholieke Universiteit Leuven/ Universitaire Ziekenhuizen, Leuven, Belgium.'}, {'ForeName': 'Jaivier', 'Initials': 'J', 'LastName': 'Pall', 'Affiliation': 'INNODIA Patient Advisory Committee, Madrid, Spain.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Arnaud', 'Affiliation': 'INNODIA Patient Advisory Committee, Paris, France.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Haller', 'Affiliation': 'Department of Pediatrics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Almut', 'Initials': 'A', 'LastName': 'Nitsche', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Anke M', 'Initials': 'AM', 'LastName': 'Schulte', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Katholieke Universiteit Leuven/ Universitaire Ziekenhuizen, Leuven, Belgium.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Mander', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dunger', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, UK.'}]",BMJ open,['10.1136/bmjopen-2021-053669']
1553,34915738,Effect of Occlusion Site on the Safety and Efficacy of Intravenous Alteplase Before Endovascular Thrombectomy: A Prespecified Subgroup Analysis of DIRECT-MT.,"BACKGROUND AND PURPOSE


Recent trials showed thrombectomy alone was comparable to bridging therapy in patients with anterior circulation large vessel occlusion eligible for both intravenous alteplase and endovascular thrombectomy. We performed this study to examine whether occlusion site modifies the effect of intravenous alteplase before thrombectomy.
METHODS


This is a prespecified subgroup analysis of a randomized trial evaluating risk and benefit of intravenous alteplase before thrombectomy (DIRECT-MT [Direct Intra-Arterial Thrombectomy in Order to Revascularize AIS Patients With Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals]). Among 658 randomized patients, 640 with baseline occlusion site information were included. The primary outcome was the score on the modified Rankin Scale at 90 days. Multivariable ordinal logistic regression analysis with an interaction term was used to estimate treatment effect modification by occlusion location (internal carotid artery versus M1 versus M2). We report the adjusted common odds ratio for a shift toward better outcome on the modified Rankin Scale after thrombectomy alone compared with combination treatment adjusted for age, the National Institutes of Health Stroke Scale score at baseline, the time from stroke onset to randomization, the modified Rankin Scale score before stroke onset, and collateral score per the DIRECT-MT statistical analysis plan.
RESULTS


The overall adjusted common odds ratio was 1.08 (95% CI, 0.82-1.43) with thrombectomy alone compared with combination treatment, and there was no significant treatment-by-occlusion site interaction ( P =0.47). In subgroups based on occlusion location, we found the following adjusted common odds ratios: 0.99 (95% CI, 0.62-1.59) for internal carotid artery occlusions, 1.12 (95% CI, 0.77-1.64) for M1 occlusions, and 1.22 (95% CI, 0.53-2.79) for M2 occlusions. No treatment-by-occlusion site interactions were observed for dichotomized modified Rankin Scale distributions and successful reperfusion (extended thrombolysis in Cerebral Infarction score ≥2b) before thrombectomy. Differences in symptomatic hemorrhage rate were not significant between occlusion locations (internal carotid artery occlusion: 7.02% in bridging therapy versus 7.14% for thrombectomy alone,  P =0.97; M1 occlusion: 5.06% versus 2.48%,  P =0.22; M2 occlusion: 9.09% versus 4.76%;  P =0.78).
CONCLUSIONS


In this prespecified subgroup of a randomized trial, we found no evidence that occlusion location can inform intravenous alteplase decisions in endovascular treatment eligible patients directly presenting at endovascular treatment capable centers. Future studies are needed to confirm our findings. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03469206.",2022,"Differences in symptomatic hemorrhage rate were not significant between occlusion locations (internal carotid artery occlusion: 7.02% in bridging therapy versus 7.14% for thrombectomy alone,  P =0.97; M1 occlusion: 5.06% versus 2.48%,  P =0.22; M2 occlusion: 9.09% versus 4.76%;  P =0.78).
","['658 randomized patients, 640 with baseline occlusion site information were included', 'patients with anterior circulation large vessel occlusion eligible for both intravenous alteplase and endovascular thrombectomy', 'endovascular treatment eligible patients directly presenting at endovascular treatment capable centers']","['Occlusion Site', 'Intravenous Alteplase Before Endovascular Thrombectomy']","['modified Rankin Scale', 'internal carotid artery occlusions', 'Safety and Efficacy', 'symptomatic hemorrhage rate', 'dichotomized modified Rankin Scale distributions and successful reperfusion', 'score on the modified Rankin Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0149853', 'cui_str': 'Occlusion of internal carotid artery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",658.0,0.199991,"Differences in symptomatic hemorrhage rate were not significant between occlusion locations (internal carotid artery occlusion: 7.02% in bridging therapy versus 7.14% for thrombectomy alone,  P =0.97; M1 occlusion: 5.06% versus 2.48%,  P =0.22; M2 occlusion: 9.09% versus 4.76%;  P =0.78).
","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Xing', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Zifu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Yongxin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Yongwei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Naval Medical University Changhai hospital, Shanghai, China (Yongwei Zhang).'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Hong', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Qinghai', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Kaijun', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zou', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Zuo', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of interventional radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University, Nanjing, China (S.L.).""}, {'ForeName': 'Liyong', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurosurgery, Linyi People's Hospital of Qingdao University, Linyi, China (L.Z.).""}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Center, location AMC, Amsterdam, the Netherlands (C.B.L.M.M., Y.B.W.E.M.R., K.M.T.).'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Center, location AMC, Amsterdam, the Netherlands (C.B.L.M.M., Y.B.W.E.M.R., K.M.T.).'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Treurniet', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Center, location AMC, Amsterdam, the Netherlands (C.B.L.M.M., Y.B.W.E.M.R., K.M.T.).'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Health Statistics Department, Naval Medical University, Shanghai, China (X.Y.).'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou, China (Y.P.).'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai hospital, Shanghai, China (Y. Zhou, P.X., Z.L., X.Z., L.Z., Yongxin Zhang, B.H., Y.X., Q.H., Q.L., K.Z., C.Z., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.121.035267']
1554,34915329,Angular gyrus connectivity at alpha and beta oscillations is reduced during tonic pain - Differential effect of eye state.,"The angular gyrus (AG) is a common hub in the pain networks. The role of the AG during pain perception, however, is still unclear. This crossover study examined the effect of tonic pain on resting state functional connectivity (rsFC) of the AG under eyes closed (EC) and eyes open (EO). It included two sessions (placebo/pain) separated by 24 hours. Pain was induced using topical capsaicin (or placebo as control) on the right forearm. Electroencephalographic rsFC assessed by Granger causality was acquired from 28 healthy participants (14 women) before (baseline) and 1-hour following the application of placebo/capsaicin. Subjects were randomly assigned and balanced to groups of recording sequence (EC-EO, EO-EC). Decreased rsFC at alpha-1 and beta, but not alpha-2, oscillations was found during pain compared to baseline during EC only. For alpha-1, EC-EO group showed a pain-induced decrease only among connections between the right AG and each of the posterior cingulate cortex (PCC, P = 0.002), medial prefrontal cortex (mPFC, P = 0.005), and the left AG (P = 0.023). For beta rsFC, the EC-EO group showed a bilateral decrease in rsFC spanning the connections between the right AG and mPFC (P = 0.015) and between the left AG and each of PCC (P = 0.004) and mPFC (P = 0.026). In contrast, the EO-EC group showed an increase in beta rsFC only among connections between the left AG and each of PCC (P = 0.012) and mPFC (P = 0.036). No significant change in the AG rsFC was found during EO. These results provide insight into the involvement of the AG in pain perception and reveal methodological considerations when assessing rsFC during EO and EC.",2022,"Decreased rsFC at alpha-1 and beta, but not alpha-2, oscillations was found during pain compared to baseline during EC only.",['28 healthy participants (14 women) before (baseline) and 1-hour following the application of'],"['EO-EC', 'AG under eyes closed (EC) and eyes open (EO', 'topical capsaicin (or placebo', 'tonic pain', 'placebo/capsaicin']","['Pain', 'beta rsFC', 'left AG', 'medial prefrontal cortex', 'AG rsFC', 'Electroencephalographic rsFC assessed by Granger causality']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0152305', 'cui_str': 'Structure of angular gyrus'}, {'cui': 'C3210186', 'cui_str': 'Capsaicin-containing product in transdermal dose form'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0152305', 'cui_str': 'Structure of angular gyrus'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]",28.0,0.0358559,"Decreased rsFC at alpha-1 and beta, but not alpha-2, oscillations was found during pain compared to baseline during EC only.","[{'ForeName': 'Najah', 'Initials': 'N', 'LastName': 'Alhajri', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Shellie Ann', 'Initials': 'SA', 'LastName': 'Boudreau', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark. Electronic address: tgn@hst.aau.dk.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2021.102907']
1555,34863948,A new photodynamic therapy protocol for nodular basal cell carcinoma treatment: Effectiveness and long-term follow-up.,"BACKGROUND


Photodynamic therapy (PDT) has been reported as an excellent option for the treatment of small nodular basal cell carcinomas (nBCC). The standard protocol consists of two sessions, one week apart. Sometimes, returning to the hospital after one week can be impractical for elderly patients, due to comorbidities and mobility issues. Therefore, a new technique performed in one day could be superior for those patients.
OBJECTIVE


Evaluate the effectiveness of a PDT Single-visit protocol comparing to the standard protocol, as well as pain and long-term recurrence-free follow-up for nBCC.
METHODS


A total of 120 nBCC were treated through a Standard PDT protocol(two sessions, one week apart), and 120 nBCC were treated through a Single-visit PDT(two sessions in one day). A 30-day-after biopsy was performed in order to evaluate the results after the treatment. The lesions that had successful treatment were clinically and dermoscopically evaluated every 6 months up to 60 months. The pain score was compared between the groups(assessed every 3 min during PDT).
RESULTS


A complete response at 30-days-after PDT biopsy was observed in 85% of Standard PDT and in 93.3% of Single-visit PDT. Regarding the pain during the illumination, less pain was observed during the second session of the Single-visit PDT. The recurrence-free follow up showed, after 60 months, an 69.0% cumulative probability of recurrence-free for Standard PDT and 80.6% for Single-visit PDT.
CONCLUSIONS


The suggested Single-visit PDT protocol resulted in better outcomes at 30-day-after PDT biopsy and in lower recurrence rates than the Standard PDT protocol. A more comfortable and more efficient treatment was offered for the patients, with lower pain.",2022,The suggested Single-visit PDT protocol resulted in better outcomes at 30-day-after PDT biopsy and in lower recurrence rates than the Standard PDT protocol.,"['nodular basal cell carcinoma treatment', 'small nodular basal cell carcinomas (nBCC']","['Photodynamic therapy (PDT', 'photodynamic therapy protocol', 'PDT Single-visit protocol']","['pain', 'recurrence rates', 'pain score']","[{'cui': 'C1304300', 'cui_str': 'Nodular basal cell carcinoma of skin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",120.0,0.120841,The suggested Single-visit PDT protocol resulted in better outcomes at 30-day-after PDT biopsy and in lower recurrence rates than the Standard PDT protocol.,"[{'ForeName': 'Ana Gabriela', 'Initials': 'AG', 'LastName': 'Salvio', 'Affiliation': 'Skin Department of Amaral Carvalho Hospital, Jahu, São Paulo, Brazil. Electronic address: gasalvio@hotmail.com.'}, {'ForeName': 'Donaldo Botelho', 'Initials': 'DB', 'LastName': 'Veneziano', 'Affiliation': 'Population Based Cancer Register of Amaral Carvalho Hospital, Jahu, São Paulo, Brazil.'}, {'ForeName': 'Lilian Tan', 'Initials': 'LT', 'LastName': 'Moriyama', 'Affiliation': 'São Carlos Institute of Physics, University of São Paulo, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Natalia Mayumi', 'Initials': 'NM', 'LastName': 'Inada', 'Affiliation': 'São Carlos Institute of Physics, University of São Paulo, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Clóvis', 'Initials': 'C', 'LastName': 'Grecco', 'Affiliation': 'Ibramed, Amparo, São Paulo, Brazil.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Kurachi', 'Affiliation': 'São Carlos Institute of Physics, University of São Paulo, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Vanderlei Salvador', 'Initials': 'VS', 'LastName': 'Bagnato', 'Affiliation': 'São Carlos Institute of Physics, University of São Paulo, São Carlos, São Paulo, Brazil; Hagler Fellow, Texas A&M University, College Station Texas, United States of America.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102668']
1556,34876432,Microbiological and clinical evaluation of ultrasonic debridement with/without erythritol air polishing during supportive periodontal therapy in arches with full-arch fixed implant-supported prostheses: protocol for a randomised controlled trial.,"INTRODUCTION


Implant-supported prostheses are often successfully used in edentulous patients. However, the incidences of peri-implant mucositis and peri-implantitis increase over time. The accumulation of pathogenic bacteria adjacent to prostheses can induce peri-implant disease. Plaque removal is recommended to prevent and manage peri-implant diseases. The purpose of this study is to compare the plaque removal efficacy of ultrasonic debridement with/without erythritol air-polishing powder around implants and bridges in patients with full-arch fixed implant-supported prostheses as well as the effects of these two methods on the rates of peri-implant mucositis and peri-implantitis, and the submucosal microbiota composition over 5 years in patients undergoing supportive periodontal therapy.
METHODS AND ANALYSIS


We plan to enrol 10 edentulous (maxilla and/or mandible) patients seeking full-arch fixed implant-supported prostheses. The study will use a split-mouth model in which contralateral quadrants are randomly assigned to two groups. Group 1: one contralateral quadrant of full-arch fixed implant-supported prostheses will undergo ultrasonic debridement combined with erythritol air-polishing powder. Group 2: a separate contralateral quadrant of full-arch fixed implant-supported prostheses will undergo ultrasonic debridement. The 5-year trial will involve a total of 10 re-examinations per participant. The mucosal conditions around the implants will be recorded at 6-month intervals after restoration. Peri-implant submucosal plaque will be collected at each re-examination, and the bacterial flora will be analysed by 16s ribosomal RNA gene sequencing. X-ray examinations will be conducted at 12-month intervals to evaluate the marginal bone level around implants.
ETHICS AND DISSEMINATION


This prospective single-centre, randomised controlled trial (PKUSSIRB-202054045) has been approved by the Ethics Committee of Stomatology School and Hospital of Peking University. Data will be registered with the International Clinical Trials Registry Platform. Additionally, we will disseminate the results via publication in scientific journals.
TRIAL REGISTRATION NUMBER


ChiCTR-2000032431.",2021,"The purpose of this study is to compare the plaque removal efficacy of ultrasonic debridement with/without erythritol air-polishing powder around implants and bridges in patients with full-arch fixed implant-supported prostheses as well as the effects of these two methods on the rates of peri-implant mucositis and peri-implantitis, and the submucosal microbiota composition over 5 years in patients undergoing supportive periodontal therapy.
METHODS AND ANALYSIS


We plan to enrol 10 edentulous (maxilla and/or mandible) patients seeking full-arch fixed implant-supported prostheses.","['arches with full-arch fixed implant-supported prostheses', '10 edentulous (maxilla and/or mandible) patients seeking full-arch fixed implant-supported prostheses', 'patients with full-arch fixed implant-supported prostheses', 'edentulous patients']","['ultrasonic debridement with/without erythritol air polishing', 'separate contralateral quadrant of full-arch fixed implant-supported prostheses will undergo ultrasonic debridement', 'ultrasonic debridement with/without erythritol air-polishing powder', 'contralateral quadrant of full-arch fixed implant-supported prostheses will undergo ultrasonic debridement combined with erythritol air-polishing powder']",['incidences of peri-implant mucositis and peri-implantitis increase over time'],"[{'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0014757', 'cui_str': 'Erythritol'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",10.0,0.0864375,"The purpose of this study is to compare the plaque removal efficacy of ultrasonic debridement with/without erythritol air-polishing powder around implants and bridges in patients with full-arch fixed implant-supported prostheses as well as the effects of these two methods on the rates of peri-implant mucositis and peri-implantitis, and the submucosal microbiota composition over 5 years in patients undergoing supportive periodontal therapy.
METHODS AND ANALYSIS


We plan to enrol 10 edentulous (maxilla and/or mandible) patients seeking full-arch fixed implant-supported prostheses.","[{'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Prosthodontics, Peking University School of Stomatology, Beijing, China.'}, {'ForeName': 'Pingyi', 'Initials': 'P', 'LastName': 'Jia', 'Affiliation': 'Department of the Fourth Clinical Division, Peking University School of Stomatology, Beijing, China.'}, {'ForeName': 'Zhaoguo', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': 'Department of Periodontology, Peking University School of Stomatology, Beijing, China.'}, {'ForeName': 'Jianzhang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School of Stomatology, Beijing, China.'}, {'ForeName': 'Zhongning', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School of Stomatology, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Prosthodontics, Peking University School of Stomatology, Beijing, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Implant dentistry, BYBO Dental Hospital Beijing, CN, Dongcheng District, Beijing, China dentistliuqi@sina.com.'}, {'ForeName': 'Jianxia', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Periodontology, Peking University School of Stomatology, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2021-053286']
1557,34876429,Mobile app for prolonged grief among bereaved parents: study protocol for a randomised controlled trial.,"INTRODUCTION


Bereaved parents, who have lost a child, have an elevated risk to develop mental health problems, yet, few studies have evaluated the effect of psychosocial interventions developed for bereaved parents. Cognitive-behavioural therapy (CBT), both face to face or digitally delivered, has shown to be an effective intervention for prolonged grief symptoms. Self-help mobile apps offer various advantages and studies show improved mental health after app interventions. No app has yet been evaluated targeting prolonged grief in bereaved parents. Therefore, the aim of this planned study is to develop and examine the effectiveness of a CBT-based mobile app, called  My Grief,  in reducing symptoms of prolonged grief, as well as other psychological symptoms, in bereaved parents. Another aim is to assess users' experiences and adverse events of  My Grief .
METHODS AND ANALYSIS


We will conduct a two-armed randomised waitlist-controlled trial. Parents living in Sweden, who lost a child between one and ten years ago, with elevated symptoms of prolonged grief, will be recruited to participate in the trial. The content of  My Grief  covers four main domains (Learn; Self-monitoring; Exercises; Get support) and builds on principles of CBT and the proven-effective  PTSD Coach  app. Participants in the intervention group will fill out online questionnaires at baseline and at 3, 6 and 12 months follow-ups, and the waitlist-controls at baseline and at 3 months. The primary outcome will be prolonged grief symptoms at the 3 months follow-up. Secondary outcomes are post-traumatic stress and depression symptoms, quality of life and cognitive behavioural variables (ie, avoidance, rumination, negative cognitions).
ETHICS AND DISSEMINATION


Ethical approval has been received from the Swedish Ethical Review Authority (project no. 2021-00770). If the app is shown to be effective, the app will be made publicly accessible on app stores, so that it can benefit other bereaved parents.
TRIAL REGISTRATION NUMBER


NCT04552717.",2021,"Parents living in Sweden, who lost a child between one and ten years ago, with elevated symptoms of prolonged grief, will be recruited to participate in the trial.","['Parents living in Sweden, who lost a child between one and ten years ago, with elevated symptoms of prolonged grief', 'bereaved parents']",['Cognitive-behavioural therapy (CBT'],"['post-traumatic stress and depression symptoms, quality of life and cognitive behavioural variables (ie, avoidance, rumination, negative cognitions', 'mental health', 'prolonged grief symptoms']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003023', 'cui_str': 'Angola'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0696578,"Parents living in Sweden, who lost a child between one and ten years ago, with elevated symptoms of prolonged grief, will be recruited to participate in the trial.","[{'ForeName': 'Rakel', 'Initials': 'R', 'LastName': 'Eklund', 'Affiliation': 'Department of Neuroscience, Uppsala University, Uppsala, Sweden rakel.eklund@neuro.uu.se.'}, {'ForeName': 'Maarten C', 'Initials': 'MC', 'LastName': 'Eisma', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Boelen', 'Affiliation': 'Department of Clinical Psychology, Faculty of Social Sciences, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Arnberg', 'Affiliation': 'Department of Neuroscience, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Sveen', 'Affiliation': 'Department of Neuroscience, Uppsala University, Uppsala, Sweden.'}]",BMJ open,['10.1136/bmjopen-2021-052763']
1558,34958374,Iron Bioavailability from Infant Cereals Containing Whole Grains and Pulses: A Stable Isotope Study in Malawian Children.,"BACKGROUND


Compared with infant cereals based on refined grains, an infant cereal containing whole grains (WGs) and pulses with adequate amounts of ascorbic acid to protect against absorption inhibitors could be a healthier source of well-absorbed iron. However, iron absorption from such cereals is uncertain.
OBJECTIVE


We measured iron bioavailability from ferrous fumarate (Fefum) added to commercial infant cereals containing 1) refined wheat flour (reference meal), 2) WG wheat and lentil flour (WG-wheat-lentil), 3) WG wheat and chickpea flour (WG-wheat-chickpeas), and 4) WG oat flour (WG-oat) and from ferrous bisglycinate (FeBG) added to the same oat-based cereal (WG-oat-FeBG).
METHODS


In a prospective, single-blinded randomized crossover study, 6- to 14-mo-old Malawian children (n = 30) consumed 25-g servings of all 5 test meals containing 2.25 mg stable isotope-labeled iron and 13.5 mg ascorbic acid. Fractional iron absorption (FIA) was assessed by erythrocyte incorporation of isotopes after 14 d. Comparisons were made using linear mixed models.
RESULTS


Seventy percent of the children were anemic and 67% were iron deficient. Geometric mean FIA percentages (-SD, +SD) from the cereals were as follows: 1) refined wheat, 12.1 (4.8, 30.6); 2) WG-wheat-lentil, 15.8 (6.6, 37.6); 3) WG-wheat-chickpeas, 12.8 (5.5, 29.8); and 4) WG-oat, 9.2 (3.9, 21.5) and 7.4 (2.9, 18.9) from WG-oat-FeBG. Meal predicted FIA (P ≤ 0.001), whereas in pairwise comparisons, only WG-oat-FeBG was significantly different compared with the refined wheat meal (P = 0.02). In addition, FIAs from WG-wheat-lentil and WG-wheat-chickpeas were significantly higher than from WG-oat (P = 0.002 and P = 0.04, respectively) and WG-oat-FeBG (P < 0.001 and P = 0.004, respectively).
CONCLUSION


In Malawian children, when given with ascorbic acid at a molar ratio of 2:1, iron bioavailability from Fefum-fortified infant cereals containing WG wheat and pulses is ≈13-15%, whereas that from FeBG- and Fefum-fortified infant cereals based on WG oats is ≈7-9%.",2022,Meal predicted FIA (P ≤ 0.001) whereas in pairwise comparisons only the WG-oat-FeBG was significantly different compared to the refined wheat meal (P = 0.02).,"['6\xa0-\xa014-month-old Malawian children (n\xa0=\xa030', 'from Infant Cereals', 'Malawian Children']","['consumed 25\xa0g servings of all five test meals containing 2.25\xa0mg stable isotope-labeled iron and 13.5\xa0mg ascorbic acid', 'Containing Whole Grains and Pulses', 'ferrous fumarate (Fefum) added to commercial infant cereals containing: 1) refined wheat flour (reference meal); 2) WG wheat and lentil flour (WG-wheat-lentil); 3) WG wheat and chickpea flour (WG-wheat-chickpeas); 4) WG oat flour (WG-oat); and from ferrous bisglycinate (FeBG) added to the same oat-based cereal (WG-oat-FeBG', 'ascorbic acid']","['Meal predicted FIA', 'Iron Bioavailability', 'Geometric mean FIAs % [-SD, +SD', 'Fractional iron absorption (FIA']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}]","[{'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4068875', 'cui_str': '2.25'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C4517559', 'cui_str': '13.5'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0060276', 'cui_str': 'Ferrous fumarate'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0458980', 'cui_str': 'Wheat flour'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0950052', 'cui_str': 'Chick peas'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C1721498', 'cui_str': 'ferrous bisglycinate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0180917', 'cui_str': 'Fluorescence immunoassay analyzer'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]",,0.156492,Meal predicted FIA (P ≤ 0.001) whereas in pairwise comparisons only the WG-oat-FeBG was significantly different compared to the refined wheat meal (P = 0.02).,"[{'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Uyoga', 'Affiliation': 'Laboratory of Human Nutrition, Institute of Food, Nutrition and Health, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Glory', 'Initials': 'G', 'LastName': 'Mzembe', 'Affiliation': 'Training and Research Unit of Excellence (TRUE), Blantyre, Malawi.'}, {'ForeName': 'Nicole U', 'Initials': 'NU', 'LastName': 'Stoffel', 'Affiliation': 'Laboratory of Human Nutrition, Institute of Food, Nutrition and Health, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Moretti', 'Affiliation': 'Laboratory of Human Nutrition, Institute of Food, Nutrition and Health, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Zeder', 'Affiliation': 'Laboratory of Human Nutrition, Institute of Food, Nutrition and Health, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Kamija', 'Initials': 'K', 'LastName': 'Phiri', 'Affiliation': 'Training and Research Unit of Excellence (TRUE), Blantyre, Malawi.'}, {'ForeName': 'Magalie', 'Initials': 'M', 'LastName': 'Sabatier', 'Affiliation': 'Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Vers-Chez-Les-Blanc, Lausanne, Switzerland.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Hays', 'Affiliation': 'Nestlé Product Technology Center-Nutrition, Société des Produits Nestlé S.A., Vevey, Switzerland.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Zimmermann', 'Affiliation': 'Laboratory of Human Nutrition, Institute of Food, Nutrition and Health, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Martin N', 'Initials': 'MN', 'LastName': 'Mwangi', 'Affiliation': 'Training and Research Unit of Excellence (TRUE), Blantyre, Malawi.'}]",The Journal of nutrition,['10.1093/jn/nxab406']
1559,34880028,"Prospective multicentre randomised clinical trial comparing survival rates, quality of life and nutritional status between advanced gastric cancer patients with different follow-up intensities: study protocol for the STOFOLUP trial.","INTRODUCTION


Patients who underwent curative gastrectomy for gastric cancer are regularly followed-up for the early detection of recurrence and postoperative symptom management. However, there is a lack of evidence with regard to proper surveillance intervals and diagnostic tools. This study aims to evaluate whether frequent surveillance tests have a survival benefit or improve the quality of life in patients who underwent curative resection for advanced gastric cancer.
METHODS AND ANALYSIS


The STOFOLUP trial is an investigator-initiated, parallel-assigned, multicentre randomised controlled trial involving 16 hospitals in the Republic of Korea. Patients (n=886) diagnosed with pathological stage II or III gastric adenocarcinoma will be randomised to either the 3-month or the 6-month group at a 1:1 ratio, stratified by trial site and tumour stage. Patients allocated to the 3-month group will undergo an abdominal CT scan every 3 months postoperatively and those allocated to the 6-month group will undergo CT every 6 months. The primary endpoint is 3-year overall survival and the secondary endpoints are quality of life, as assessed using KOrean QUality of life in Stomach cancer patients Study group-40, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the stomach cancer-specific module (STO22), and nutritional outcomes. Other survival data including data concerning 3-year disease-free survival, recurrence-free survival, gastric cancer-specific survival and postrecurrence survival will also be estimated. The first patient was enrolled on July 2021 and active patient enrolment is currently underway.
ETHICS AND DISSEMINATION


This study has been approved by the Institutional Review Board of eight of the participating hospitals (NCC 2021-0085, KBSMC2021-01-059, SMC 2021-01-140, KC21OEDE0082, 4-2021-0281, AJIRB-MED-INT-20-608, 2021-0515 and H-2102-093-1198). This study will be disseminated through peer-reviewed publications, national or international conferences.
TRIAL REGISTRATION NUMBER


NCT04740346.",2021,"Other survival data including data concerning 3-year disease-free survival, recurrence-free survival, gastric cancer-specific survival and postrecurrence survival will also be estimated.","['16 hospitals in the Republic of Korea', 'advanced gastric cancer patients with different follow-up intensities', 'participating hospitals (NCC 2021-0085, KBSMC2021-01-059, SMC 2021-01-140, KC21OEDE0082, 4-2021-0281, AJIRB-MED-INT-20-608, 2021-0515 and H-2102-093-1198', 'patients who underwent curative resection for advanced gastric cancer', 'Patients (n=886) diagnosed with pathological stage II or III gastric adenocarcinoma']","['curative gastrectomy', 'abdominal CT scan']","['quality of life, as assessed using KOrean QUality of life in Stomach cancer patients Study group-40, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the stomach cancer-specific module (STO22), and nutritional outcomes', 'survival rates, quality of life and nutritional status', 'survival data including data concerning 3-year disease-free survival, recurrence-free survival, gastric cancer-specific survival and postrecurrence survival', '3-year overall survival', 'quality of life']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0278701', 'cui_str': 'Adenocarcinoma of stomach'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0412620', 'cui_str': 'CT of abdomen'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",16.0,0.375764,"Other survival data including data concerning 3-year disease-free survival, recurrence-free survival, gastric cancer-specific survival and postrecurrence survival will also be estimated.","[{'ForeName': 'Bang Wool', 'Initials': 'BW', 'LastName': 'Eom', 'Affiliation': 'Center for Gastric Cancer, National Cancer Center, Goyang, The Republic of Korea.'}, {'ForeName': 'Dong-Hoe', 'Initials': 'DH', 'LastName': 'Koo', 'Affiliation': 'Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Ji Yeong', 'Initials': 'JY', 'LastName': 'An', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Han Hong', 'Initials': 'HH', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, The Republic of Korea.""}, {'ForeName': 'Hyoung-Il', 'Initials': 'HI', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Yonsei University Severance Hospital, Yonsei University School of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Hoon', 'Initials': 'H', 'LastName': 'Hur', 'Affiliation': 'Department of Surgery, Ajou University Hospital, Ajou University School of Medicine, Suwon, The Republic of Korea.'}, {'ForeName': 'Moon-Won', 'Initials': 'MW', 'LastName': 'Yoo', 'Affiliation': 'Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Min-Hee', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Hyuk-Joon', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery and Cancer Research Institute, Seoul National University Hospital, Seoul National University of College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Su Mi', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, CHA Bundang Medical Center, CHA University, Seongnam, The Republic of Korea.'}, {'ForeName': 'Ji-Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, The Republic of Korea.'}, {'ForeName': 'Jae Seok', 'Initials': 'JS', 'LastName': 'Min', 'Affiliation': 'Department of Surgery, Dongnam Institute of Radiological and Medical Sciences, Busan, The Republic of Korea.'}, {'ForeName': 'Kyung Won', 'Initials': 'KW', 'LastName': 'Seo', 'Affiliation': 'Department of Surgery, Kosin University Gospel Hospital, Kosin University College of Medicine, Busan, The Republic of Korea.'}, {'ForeName': 'Sang-Ho', 'Initials': 'SH', 'LastName': 'Jeong', 'Affiliation': 'Department of Surgery, Gyeongsang National University Changwon Hospital, Gyeongsang National University School of Medicine, Changwon, The Republic of Korea.'}, {'ForeName': 'Oh', 'Initials': 'O', 'LastName': 'Jeong', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun-gun, The Republic of Korea.'}, {'ForeName': 'Oh Kyoung', 'Initials': 'OK', 'LastName': 'Kwon', 'Affiliation': 'Department of Surgery, Kyungpook National University Chilgok Hospital, Kyungpook National University School of Medicine, Daegu, The Republic of Korea.'}, {'ForeName': 'Seung Wan', 'Initials': 'SW', 'LastName': 'Ryu', 'Affiliation': 'Department of Surgery, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, The Republic of Korea.'}, {'ForeName': 'Chang Hak', 'Initials': 'CH', 'LastName': 'Yoo', 'Affiliation': 'Department of Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Jae Moon', 'Initials': 'JM', 'LastName': 'Bae', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Keun Won', 'Initials': 'KW', 'LastName': 'Ryu', 'Affiliation': 'Center for Gastric Cancer, National Cancer Center, Goyang, The Republic of Korea docryu@ncc.re.kr.'}]",BMJ open,['10.1136/bmjopen-2021-056187']
1560,34880026,Determining the effectiveness of cognitive behavioural therapy in improving quality of life in patients undergoing endometriosis surgery: a study protocol for a randomised controlled trial.,"INTRODUCTION


Endometriosis can cause chronic pain and subfertility thereby negatively affecting quality of life (QoL). Surgical removal of endometriosis lesions leads to improved health-related QoL, although not to the level of QoL of healthy controls. Pain intensity and cognitions regarding pain can play a crucial role in this health-related QoL following surgical treatment. Cognitive behavioural therapy (CBT) is a psychological treatment. In patients with chronic pain caused by a variety of medical conditions, CBT is effective in improving QoL. We designed a research protocol to investigate the effect of CBT on QoL in patients with endometriosis-associated chronic pain who are undergoing surgery.
METHODS AND ANALYSIS


This is a study protocol for a randomised controlled trial in which 100 patients, undergoing endometriosis removal surgery due to endometriosis-associated chronic pain, will be randomised between post-surgery usual care with CBT and post-surgery usual care only. Participants in the CBT group will additionally receive seven sessions of CBT, focused on expectancy management, cognitions regarding pain and emotional and behavioural impact of pain. To determine the primary outcome Quality of life, both groups will complete questionnaires assessing QoL. The secondary outcomes pain intensity, pain cognitions, fatigue and perceived stress are also measured using questionnaires. Additionally, a marker for stress (cortisol extracted from a hair sample) will be assessed at T0 (baseline assessment), T1 (post-intervention; 2 weeks after completion of all CBT sessions) and T2 (follow-up; 14 weeks after T1). Statistical analysis will be performed using SPSS software.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Medical Ethical Committee of the region Arnhem-Nijmegen from the Radboud University Medical Centre on 2 September 2020. The findings of this study will be published in scientific journals and will be presented at scientific conferences.
TRIAL REGISTRATION NUMBER


NCT04448366.",2021,"Surgical removal of endometriosis lesions leads to improved health-related QoL, although not to the level of QoL of healthy controls.","['100 patients, undergoing endometriosis removal surgery due to endometriosis-associated chronic pain, will be randomised between post-surgery usual care with CBT and post-surgery usual care only', 'patients undergoing endometriosis surgery', 'patients with chronic pain', 'patients with endometriosis-associated chronic pain who are undergoing surgery']","['cognitive behavioural therapy', 'CBT', 'Cognitive behavioural therapy (CBT']","['Pain intensity and cognitions regarding pain', 'pain intensity, pain cognitions, fatigue and perceived stress are also measured using questionnaires', 'quality of life', 'expectancy management, cognitions regarding pain and emotional and behavioural impact of pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",,0.19001,"Surgical removal of endometriosis lesions leads to improved health-related QoL, although not to the level of QoL of healthy controls.","[{'ForeName': 'Zoë', 'Initials': 'Z', 'LastName': 'Boersen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hospital Rijnstate Arnhem, Arnhem, Gelderland, The Netherlands zboersen@rijnstate.nl.'}, {'ForeName': 'Joukje', 'Initials': 'J', 'LastName': 'Oosterman', 'Affiliation': 'Radboud University Donders Institute for Brain Cognition and Behaviour, Nijmegen, Gelderland, The Netherlands.'}, {'ForeName': 'Esther Gerdien', 'Initials': 'EG', 'LastName': 'Hameleers', 'Affiliation': 'Department of Medical Psychology, Hospital Rijnstate Arnhem, Arnhem, Gelderland, The Netherlands.'}, {'ForeName': 'Heidi Sabine Mathilde Jeanne', 'Initials': 'HSMJ', 'LastName': 'Delcliseur', 'Affiliation': 'Department of Medical Psychology, Hospital Rijnstate Arnhem, Arnhem, Gelderland, The Netherlands.'}, {'ForeName': 'Cobie', 'Initials': 'C', 'LastName': 'Lutters', 'Affiliation': 'Endometriose in Balans, Medisch Centrum Haaglanden, Den Haag, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'IJssel de Schepper', 'Affiliation': 'Department of Medical Psychology, Radboudumc, Nijmegen, Gelderland, The Netherlands.'}, {'ForeName': 'Didi', 'Initials': 'D', 'LastName': 'Braat', 'Affiliation': 'Department of Obstetrics and Gynecology, Radboudumc, Nijmegen, Gelderland, The Netherlands.'}, {'ForeName': 'Christianne M', 'Initials': 'CM', 'LastName': 'Verhaak', 'Affiliation': 'Department of Medical Psychology, Radboudumc, Nijmegen, Gelderland, The Netherlands.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Nap', 'Affiliation': 'Department of Obstetrics and Gynecology, Radboudumc, Nijmegen, Gelderland, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2021-054896']
1561,34893487,Study protocol for a randomised clinical trial of a decision aid and values clarification method for parents of a fetus or neonate diagnosed with a life-threatening congenital heart defect.,"INTRODUCTION


Parents who receive the diagnosis of a life-threatening, complex heart defect in their fetus or neonate face a difficult choice between pursuing termination (for fetal diagnoses), palliative care or complex surgical interventions. Shared decision making (SDM) is recommended in clinical contexts where there is clinical equipoise. SDM can be facilitated by decision aids. The International Patient Decision Aids Standards collaboration recommends the inclusion of values clarification methods (VCMs), yet little evidence exists concerning the incremental impact of VCMs on patient or surrogate decision making. This protocol describes a randomised clinical trial to evaluate the effect of a decision aid (with and without a VCM) on parental mental health and decision making within a clinical encounter.
METHODS AND ANALYSIS


Parents who have a fetus or neonate diagnosed with one of six complex congenital heart defects at a single tertiary centre will be recruited. Data collection for the prospective observational control group was conducted September 2018 to December 2020 (N=35) and data collection for two intervention groups is ongoing (began October 2020). At least 100 participants will be randomised 1:1 to two intervention groups (decision aid only vs decision aid with VCM). For the intervention groups, data will be collected at four time points: (1) at diagnosis, (2) postreceipt of decision aid, (3) postdecision and (4) 3 months postdecision. Data collection for the control group was the same, except they did not receive a survey at time 2. Linear mixed effects models will assess differences between study arms in distress (primary outcome), grief and decision quality (secondary outcomes) at 3-month post-treatment decision.
ETHICS AND DISSEMINATION


This study was approved by the University of Utah Institutional Review Board. Study findings have and will continue to be presented at national conferences and within scientific research journals.
TRIAL REGISTRATION NUMBER


NCT04437069 (Pre-results).",2021,"This protocol describes a randomised clinical trial to evaluate the effect of a decision aid (with and without a VCM) on parental mental health and decision making within a clinical encounter.
","['At least 100 participants', 'September 2018 to December 2020 (N=35) and data collection for two intervention groups is ongoing (began October 2020', 'parents of a fetus or neonate diagnosed with a life-threatening congenital heart defect', 'Parents who have a fetus or neonate diagnosed with one of six complex congenital heart defects at a single tertiary centre will be recruited']","['decision aid (with and without a VCM', 'intervention groups (decision aid only vs decision aid with VCM', 'decision aid and values clarification method', 'palliative care or complex surgical interventions']",['grief and decision quality'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0018798', 'cui_str': 'Congenital malformation of heart, unspecified'}, {'cui': 'C3536558', 'cui_str': 'Complex congenital heart defect'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150401', 'cui_str': 'Values clarification'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.159223,"This protocol describes a randomised clinical trial to evaluate the effect of a decision aid (with and without a VCM) on parental mental health and decision making within a clinical encounter.
","[{'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Delaney', 'Affiliation': 'Population Health Sciences, The University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Nelangi M', 'Initials': 'NM', 'LastName': 'Pinto', 'Affiliation': 'Pediatrics, University of Utah Health, Salt Lake City, Utah, USA.'}, {'ForeName': 'Elissa M', 'Initials': 'EM', 'LastName': 'Ozanne', 'Affiliation': 'Population Health Sciences, The University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Louisa A', 'Initials': 'LA', 'LastName': 'Stark', 'Affiliation': 'Human Genetics, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Mandy L', 'Initials': 'ML', 'LastName': 'Pershing', 'Affiliation': 'Population Health Sciences, The University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Thorpe', 'Affiliation': 'Population Health Sciences, The University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Holly O', 'Initials': 'HO', 'LastName': 'Witteman', 'Affiliation': 'Family and Emergency Medicine, Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Thokala', 'Affiliation': 'School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Lambert', 'Affiliation': 'Pediatrics, University of Utah Health, Salt Lake City, Utah, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Hansen', 'Affiliation': 'Pediatrics, University of Utah Health, Salt Lake City, Utah, USA.'}, {'ForeName': 'Tom H', 'Initials': 'TH', 'LastName': 'Greene', 'Affiliation': 'Population Health Sciences, The University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fagerlin', 'Affiliation': 'Population Health Sciences, The University of Utah School of Medicine, Salt Lake City, Utah, USA angie.fagerlin@hsc.utah.edu.'}]",BMJ open,['10.1136/bmjopen-2021-055455']
1562,34967942,Economic evaluation of deep brain stimulation compared with vagus nerve stimulation and usual care for patients with refractory epilepsy: A lifetime decision analytic model.,"OBJECTIVES


This study was undertaken to estimate the cost-effectiveness of deep brain stimulation (DBS) compared with vagus nerve stimulation (VNS) and care as usual (CAU) for adult patients with refractory epilepsy from a health care perspective using a lifetime decision analytic model.
METHODS


A Markov decision analytic model was constructed to estimate the lifetime cost-effectiveness of DBS compared with VNS and CAU. Transition probabilities were estimated from a randomized controlled trial, and assumptions were made in consensus with an expert panel. Primary outcomes were expressed as incremental costs per quality-adjusted life-year (QALY) and per responder. Univariate and probabilistic sensitivity analyses were conducted to characterize parameter uncertainty.
RESULTS


In DBS, 28.4% of the patients were responders, with an average of 21.38 QALYs per patient and expected lifetime health care costs of €187 791. VNS had fewer responders (22.3%), fewer QALYs (20.70), and lower lifetime costs (€156 871). CAU had the fewest responders (6.2%), fewest QALYs (18.74), and lowest total health care costs (€64 670). When comparing with CAU, incremental cost-effectiveness ratios (ICERs) showed that costs per QALY gained were slightly lower for DBS (€46 640) than for VNS (€47 155). When comparing DBS with VNS, an incremental cost per additional QALY gained of €45 170 was found for DBS. Sensitivity analyses showed that ICERs were heavily dependent on assumptions regarding loss to follow-up in the respective clinical trial.
SIGNIFICANCE


This study suggests that, given current limited evidence, VNS and DBS are potentially cost-effective treatment strategies compared to CAU for patients with refractory epilepsy. However, results for DBS were heavily impacted by assumptions made to extrapolate nonresponse from the original trial. More stringent assumptions regarding nonresponse resulted in an ICER just above an acceptable willingness to pay threshold. Given the uncertainty surrounding the effectiveness of DBS and the large impact of assumptions related to nonresponse, further empirical research is needed to reduce uncertainty.",2022,"When comparing DBS with VNS, an incremental cost per additional QALY gained of €45 170 was found for DBS.","['adult patients with refractory epilepsy from a health care perspective using a lifetime decision analytic model', 'patients with refractory epilepsy']","['deep brain stimulation', 'vagus nerve stimulation and usual care', 'vagus nerve stimulation (VNS) and care as usual (CAU', 'VNS and CAU', 'deep brain stimulation (DBS']","['lower lifetime costs', 'lifetime health care costs', 'lowest total health care costs', 'incremental cost-effectiveness ratios (ICERs', 'incremental costs per quality-adjusted life-year (QALY) and per responder', 'lifetime cost-effectiveness of DBS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]",,0.0555679,"When comparing DBS with VNS, an incremental cost per additional QALY gained of €45 170 was found for DBS.","[{'ForeName': 'Hoi Yau', 'Initials': 'HY', 'LastName': 'Chan', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Ben F M', 'Initials': 'BFM', 'LastName': 'Wijnen', 'Affiliation': 'Center for Economic Evaluation and Machine Learning, Trimbos Institute, Netherlands Institute of Mental Health and Addiction, Utrecht, the Netherlands.'}, {'ForeName': 'Marian H J M', 'Initials': 'MHJM', 'LastName': 'Majoie', 'Affiliation': 'Department of Research and Development, Epilepsy Center Kempenhaeghe, Heeze, the Netherlands.'}, {'ForeName': 'Silvia M A A', 'Initials': 'SMAA', 'LastName': 'Evers', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Mickaël', 'Initials': 'M', 'LastName': 'Hiligsmann', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}]",Epilepsia,['10.1111/epi.17158']
1563,34959080,Association of chronic liver disease with cognition and brain volumes in two randomized controlled trial populations.,"BACKGROUND AND PURPOSE


We examined the association of chronic liver disease with cognition and brain imaging markers of cognitive impairment using data from two large randomized controlled trials that included participants based on diabetes and hypertension, two common systemic risk factors for cognitive impairment and dementia.
METHODS


We performed post hoc analyses using data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) and Systolic Blood Pressure Intervention Trial (SPRINT) studies, which included participants with diabetes and hypertension, respectively. Data were from the NHLBI Biologic Specimen and Data Repository Information Coordinating Center. In ACCORD, our measure of chronic liver disease was the Dallas Steatosis Index (DSI). In SPRINT, we used self-reported chronic liver disease. We used linear regression to evaluate the association between the measure of chronic liver disease and both baseline and longitudinal cognitive test performance and brain magnetic resonance imaging volume measurements.
RESULTS


Among 2969 diabetic participants in ACCORD, the mean age of participants was 62 years, 47% were women. The median DSI was 1.0 (IQR, 0.2-1.8); a DSI of 1.0 corresponds to approximately a > 70% probability of having NAFLD. Among 2890 hypertensive participants in SPRINT, the mean age was 68 years, and 37% were women, and 60 (2.1%) had chronic liver disease. There were no consistent associations between liver disease and cognitive performance or brain volumes at baseline or longitudinally after adjustment.
CONCLUSION


Markers of chronic liver disease were not associated with cognitive impairment or related brain imaging markers among individuals with diabetes and hypertension.",2021,"CONCLUSION


Markers of chronic liver disease were not associated with cognitive impairment or related brain imaging markers among individuals with diabetes and hypertension.","['2890 hypertensive participants in SPRINT, the mean age was 68\xa0years, and 37% were women, and 60 (2.1%) had chronic liver disease', 'participants based on diabetes and hypertension, two common systemic risk factors for cognitive impairment and dementia', 'individuals with diabetes and hypertension', 'Diabetes (ACCORD) and Systolic Blood Pressure Intervention Trial', 'participants with diabetes and hypertension, respectively', '2969 diabetic participants in ACCORD, the mean age of participants was 62\xa0years, 47% were women']",[],"['Dallas Steatosis Index (DSI', 'median DSI', 'liver disease and cognitive performance or brain volumes']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]",[],"[{'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",2969.0,0.205035,"CONCLUSION


Markers of chronic liver disease were not associated with cognitive impairment or related brain imaging markers among individuals with diabetes and hypertension.","[{'ForeName': 'Elora', 'Initials': 'E', 'LastName': 'Basu', 'Affiliation': 'Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute and Department of Neurology, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Manaav', 'Initials': 'M', 'LastName': 'Mehta', 'Affiliation': 'Department of Bioengineering, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Cenai', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute and Department of Neurology, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Penn State Milton S. Hershey Medical Center, and Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Rosenblatt', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Elliot B', 'Initials': 'EB', 'LastName': 'Tapper', 'Affiliation': 'Department of Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Neal S', 'Initials': 'NS', 'LastName': 'Parikh', 'Affiliation': 'Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute and Department of Neurology, Weill Cornell Medicine, New York, NY, USA. Electronic address: nsp2001@med.cornell.edu.'}]",Journal of the neurological sciences,['10.1016/j.jns.2021.120117']
1564,34972770,"Implementation, efficacy and cost effectiveness of the unified protocol in a blended format for the transdiagnostic treatment of emotional disorders: a study protocol for a multicentre, randomised, superiority controlled trial in the Spanish National Health System.","INTRODUCTION


Emotional disorders (EDs) have become the most prevalent psychological disorders in the general population, which has boosted the economic burden associated with their management. Approximately half of the individuals do not receive adequate treatment. Consequently, finding solutions to deliver cost-effective treatments for EDs has become a key goal of today's clinical psychology. Blended treatments, a combination of face-to-face and online interventions, have emerged as a potential solution to the previous. The Unified Protocol for the Transdiagnostic Treatment of EDs (UP) might serve this purpose, as it can be applied to a variety of disorders simultaneously and its manualised format makes it suitable for blended interventions.
METHODS AND ANALYSIS


The study is a multicentre, randomised, superiority, clinical trial. Participants will be 310 individuals with a diagnosis of an ED. They will be randomised to a treatment as usual (individual cognitive behavioural therapy) or a UP condition in a blended format (face-to-face individual UP +online, app-based UP). Primary outcomes will be ED diagnostic criteria and depression and anxiety symptoms. Cost efficiency of the intervention, app usability, as well as opinion and confidence in the treatment will also be evaluated. Assessment points will include baseline and 3 months, 6 months and 12 months after UP treatment.
ETHICS AND DISSEMINATION


The study has received approvals by the Ethics Research Committee of Navarra, Castellón, Euskadi, Castilla y León, Extremadura, Lleida and Aragón. The study is currently under an approval process by the Ethics Research Committees of all the remaining collaborating centres. Outcomes will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.
TRIAL REGISTRATION NUMBER


NCT04304911.",2021,"They will be randomised to a treatment as usual (individual cognitive behavioural therapy) or a UP condition in a blended format (face-to-face individual UP +online, app-based UP).","['310 individuals with a diagnosis of an ED', 'emotional disorders']",[],"['ED diagnostic criteria and depression and anxiety symptoms', 'efficacy and cost effectiveness', 'Cost efficiency']","[{'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",310.0,0.189678,"They will be randomised to a treatment as usual (individual cognitive behavioural therapy) or a UP condition in a blended format (face-to-face individual UP +online, app-based UP).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Osma', 'Affiliation': 'Departamento de Psicología y Sociología, Universidad de Zaragoza, Teruel, Spain osma@unizar.es.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Martínez-García', 'Affiliation': 'Departamento de Psicología y Sociología, Universidad de Zaragoza, Teruel, Spain.'}, {'ForeName': 'Óscar', 'Initials': 'Ó', 'LastName': 'Peris-Baquero', 'Affiliation': 'Departamento de Psicología y Sociología, Universidad de Zaragoza, Teruel, Spain.'}, {'ForeName': 'María Vicenta', 'Initials': 'MV', 'LastName': 'Navarro-Haro', 'Affiliation': 'Departamento de Psicología y Sociología, Universidad de Zaragoza, Teruel, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'González-Pérez', 'Affiliation': 'Universitat Jaume I, Castelló de la Plana, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Suso-Ribera', 'Affiliation': 'Universitat Jaume I, Castelló de la Plana, Spain.'}]",BMJ open,['10.1136/bmjopen-2021-054286']
1565,34971074,"The effectiveness of in-office dental bleaching with and without sonic activation: A randomized, split-mouth, double-blind clinical trial.","OBJECTIVE


This study was aimed at comparing the bleaching efficacy and bleaching sensitivity (BS) of two higher-concentration in-office bleaching gels (37% carbamide peroxide [CP] and 38% hydrogen peroxide [HP]) applied under two conditions: alone or in association with sonic activation.
METHODS


Fifty-six volunteers were randomly assigned in the split-mouth design into the following groups: CP, CP with sonic activation (CPS), HP, and HP with sonic activation (HPS). Two in-office bleaching sessions were performed. Color was evaluated using Vita Classical, Vita Bleachedguide, and digital spectrophotometer at baseline and at 30 days post-bleaching. Absolute risk and intensity of BS were recorded using two pain scales. All data were evaluated statistically (color changes [t test], BS [Chi-square and McNemar test], and BS intensity [VAS; t test; NRS; Wilcoxon; α = 0.05]).
RESULTS


Significant and higher whitening was observed for HP when compared with CP (p < 0.04). However, higher BS intensity was observed in the former (p < 0.001). No significant difference was observed in whitening effect or BS when the HP or CP bleaching gels were agitated (sonic application) compared with when they were not (p > 0.05).
CONCLUSION


The 37% CP gel demonstrated lower bleaching efficacy and lower BS compared with the 38% HP bleaching gel. The whitening effect was not influenced by the use of sonic activation.
CLINICAL SIGNIFICANCE


The use of 37% CP gel did not achieve the same whitening effect when compared to 38% HP gel used for in-office bleaching. The use of sonic activation offers no benefit for in-office bleaching.",2022,The use of 37% CP gel did not achieve the same whitening effect when compared to 38% HP gel used for in-office bleaching.,['Fifty-six volunteers'],"['CP, CP with sonic activation (CPS), HP, and HP with sonic activation (HPS', 'carbamide peroxide [CP] and 38% hydrogen peroxide [HP']","['higher BS intensity', 'Absolute risk and intensity of BS', 'bleaching efficacy and bleaching sensitivity (BS', 'bleaching efficacy and lower BS', 'whitening effect or BS']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",56.0,0.0515784,The use of 37% CP gel did not achieve the same whitening effect when compared to 38% HP gel used for in-office bleaching.,"[{'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'de Moura Martins', 'Affiliation': 'School of Dentistry, Federal University of Amazonas, Manaus, AM, Brazil.'}, {'ForeName': 'Gabriel Guedes', 'Initials': 'GG', 'LastName': 'de Azevedo Cardoso', 'Affiliation': 'School of Dentistry, Federal University of Amazonas, Manaus, AM, Brazil.'}, {'ForeName': 'Liliane Motta', 'Initials': 'LM', 'LastName': 'de Lima', 'Affiliation': 'School of Dentistry, Federal University of Amazonas, Manaus, AM, Brazil.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Rezende', 'Affiliation': 'School of Dentistry, Paulo Picanço School of Dentistry, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Elisama', 'Initials': 'E', 'LastName': 'Sutil', 'Affiliation': 'School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Puerto Rico, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Puerto Rico, Brazil.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Puerto Rico, Brazil.'}, {'ForeName': 'Luciana Mendonça', 'Initials': 'LM', 'LastName': 'da Silva', 'Affiliation': 'School of Dentistry, Federal University of Amazonas, Manaus, AM, Brazil.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12863']
1566,34872040,"The impact of dexamethasone as a perineural additive to ropivacaine for PECS II blockade in patients undergoing unilateral radical mastectomy - A prospective, randomized, controlled and double-blinded trial.","STUDY OBJECTIVE


Dexamethasone is commonly used as an adjuvant to local anesthetics to prolong duration of peripheral nerve blocks with minimal side-effects. The present study investigates the efficacy of dexamethasone added to ropivacaine 0.2% as compared to ropivacaine 0.2% alone for pectoral nerves block II (PECS II) in unilateral radical mastectomy.
DESIGN


A prospective, randomized, controlled and double-blinded trial.
SETTING


The study was performed at Innsbruck Medical University Hospital, Austria, between January 2019 and October 2020.
PATIENTS


Sixty female patients with an American Society of Anesthesiologists Score I-II (18-90 years, BMI 18-35) scheduled for unilateral radical mastectomy without one-stage immediate autologous breast reconstruction were randomly assigned to receive PECS II block with ropivacaine 0.2% with or without dexamethasone 8 mg.
INTERVENTIONS


Patients were randomly assigned to receive PECS II block with ropivacaine 0.2% with or without dexamethasone 8 mg.
MEASUREMENTS


Primary outcome parameter was the cumulative opioid consumption during the first 72 postoperative hours. Secondary outcome parameters were the duration of analgesia and the course of the visual analogue scale (VAS) and the area under the curve VAS (AUC-VAS).
MAIN RESULTS


There was no difference in cumulative opioid consumption after 72 h between the ropivacaine 0.2% plus dexamethasone group and the ropivacaine 0.2% plus placebo group (11.89 vs 11.90 morphine milligram equivalent, respectively; p 0.831). Duration of analgesia also did not differ significantly between the ropivacaine 0.2% plus dexamethasone group and the ropivacaine 0.2% plus placebo group (12.75 versus 8.75 h, respectively; p 0.680). There also was no difference in the course of VAS and AUC-VAS.
CONCLUSIONS


Dexamethasone 8 mg when added to ropivacaine 0.2% for PECS II block in unilateral radical mastectomy was not found to reduce total opioid consumption over 72 postoperative hours or to prolong duration of analgesia as compared to pure ropivacaine 0.2%.",2022,"There was no difference in cumulative opioid consumption after 72 h between the ropivacaine 0.2% plus dexamethasone group and the ropivacaine 0.2% plus placebo group (11.89 vs 11.90 morphine milligram equivalent, respectively; p 0.831).","['The study was performed at Innsbruck Medical University Hospital, Austria, between January 2019 and October 2020', 'without one-stage immediate autologous breast reconstruction', 'Sixty female patients with an American Society of Anesthesiologists Score I-II (18-90\xa0years, BMI 18-35) scheduled for', 'patients undergoing unilateral radical mastectomy ', 'pectoral nerves block II (PECS II) in unilateral radical mastectomy']","['dexamethasone', 'placebo', 'Dexamethasone', 'ropivacaine', 'unilateral radical mastectomy', 'PECS II block with ropivacaine 0.2% with or without dexamethasone 8\xa0mg']","['total opioid consumption', 'Duration of analgesia', 'course of VAS and AUC-VAS', 'duration of analgesia and the course of the visual analogue scale (VAS) and the area under the curve VAS (AUC-VAS', 'cumulative opioid consumption']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0024884', 'cui_str': 'Radical mastectomy'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0024884', 'cui_str': 'Radical mastectomy'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",60.0,0.545669,"There was no difference in cumulative opioid consumption after 72 h between the ropivacaine 0.2% plus dexamethasone group and the ropivacaine 0.2% plus placebo group (11.89 vs 11.90 morphine milligram equivalent, respectively; p 0.831).","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Hoerner', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Gasteiger', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Innsbruck, Austria. Electronic address: lukas.gasteiger@tirol-kliniken.at.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ortler', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Vitaliy', 'Initials': 'V', 'LastName': 'Pustilnik', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Mathis', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Brunner', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Neururer', 'Affiliation': 'Department of Medical Statistics, Informatics and Health Economics, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schlager', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Egle', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Guenther', 'Initials': 'G', 'LastName': 'Putz', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Medical University of Innsbruck, Austria.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110622']
1567,34878438,Genital Mucosal Drug Concentrations and anti-HIV Activity in Tenofovir-Based PrEP Products: Intravaginal Ring vs. Oral Administration.,"OBJECTIVE


To describe and compare systemic and local pharmacokinetics (PK) and cervicovaginal (CV) pharmacodynamics (PD) of oral tenofovir disoproxil fumarate (TDF) in combination with emtricitabine (FTC) with tenofovir (TFV) intravaginal ring (IVR).
DESIGN


Phase I, randomized, parallel-group study. Women (n = 22) used TDF/FTC oral tablets daily or TFV IVR continuously and were assessed at baseline and 14 days.
METHODS


TFV and FTC concentrations were measured in plasma, CV fluid (CVF), and CV tissue. TFV-diphosphate and FTC-triphosphate were assessed in CV tissue. In vitro PD antiviral activities of TFV and FTC (using in vivo concentration ranges) were modeled in the CVF and by infecting CV tissue explants ex vivo with HIV-1BaL.
RESULTS


Adverse events (AEs) were more common with oral TDF/FTC use (P < 0.01). The median CVF TFV concentrations were 106 ng/mL after use of TFV IVR vs. 102 ng/mL for TDF/FTC. The median TFV and TFV-diphosphate concentrations in CV tissue were >100-fold higher among IVR users. The median CVF FTC concentrations were 103 ng/mL. FTC and FTC-triphosphate were detected in all CV tissues from TDF/FTC users. HIV inhibitory activity of CVF increased significantly with treatment in both cohorts (P < 0.01) but was higher in TFV IVR users (P < 0.01). In vitro inhibition of tissue infection with ex vivo administration of TFV and FTC was dose dependent, with maximal efficacy achieved with 10 µg/mL TFV, 1 µg/mL FTC, and 0.1 µg/mL of TFV and FTC combined.
CONCLUSIONS


Both products were safe and increased mucosal HIV inhibitory activity. In addition to systemic protection, oral TDF/FTC displays a PK/PD profile compatible with CV mucosal antiviral activity. TFV IVR resulted in fewer AEs, lower TFV plasma concentrations, higher CVF and tissue TFV and TFV-DP concentrations, and greater anti-HIV activity in CVF.",2022,HIV inhibitory activity of CVF increased significantly with treatment in both cohorts (P < 0.01) but was higher in TFV IVR users (P < 0.01).,[],"['Intravaginal Ring vs. Oral Administration', 'emtricitabine (FTC) with tenofovir (TFV) intravaginal ring (IVR', 'Tenofovir-Based PrEP Products', 'cervicovaginal (CV) pharmacodynamics (PD) of oral tenofovir disoproxil fumarate (TDF', 'TFV and FTC', 'TDF/FTC oral tablets daily or TFV IVR']","['median CVF FTC concentrations', 'TFV-diphosphate and FTC-triphosphate', 'HIV inhibitory activity of CVF', 'TFV plasma concentrations, higher CVF and tissue TFV and TFV-DP concentrations, and greater anti-HIV activity', 'mucosal HIV inhibitory activity', 'plasma, CV fluid (CVF), and CV tissue', 'median CVF TFV concentrations', 'Genital Mucosal Drug Concentrations and anti-HIV Activity', 'median TFV and TFV-diphosphate concentrations in CV tissue']",[],"[{'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0993159', 'cui_str': 'Oral tablet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3712637', 'cui_str': 'tenofovir diphosphate'}, {'cui': 'C0077289', 'cui_str': 'tris(chloroethyl)phosphate'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.125196,HIV inhibitory activity of CVF increased significantly with treatment in both cohorts (P < 0.01) but was higher in TFV IVR users (P < 0.01).,"[{'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Ouattara', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk and Arlington, VA; and.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Thurman', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk and Arlington, VA; and.'}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Jacot', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk and Arlington, VA; and.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Cottrell', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Sykes', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Blake', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk and Arlington, VA; and.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ju', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk and Arlington, VA; and.'}, {'ForeName': 'Nikolas C', 'Initials': 'NC', 'LastName': 'Vann', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk and Arlington, VA; and.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk and Arlington, VA; and.'}, {'ForeName': 'Gustavo F', 'Initials': 'GF', 'LastName': 'Doncel', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Norfolk and Arlington, VA; and.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002820']
1568,34896568,"Effects of resistance exercise and whey protein supplementation on skeletal muscle strength, mass, physical function, and hormonal and inflammatory biomarkers in healthy active older men: a randomised, double-blind, placebo-controlled trial.","PURPOSE


To determine the individual and combined effects of 12 weeks of resistance exercise (RE) and whey protein supplementation on skeletal muscle strength (primary outcome), mass and physical function, and hormonal and inflammatory biomarkers in older adults.
METHODS


Thirty-six healthy older men [(mean±SE) age: 67±1 y; BMI: 25.5±0.4 kg/m 2 ] were randomised to either control (CON; n=9), whey protein (PRO; n=9), RE+control (EX+CON; n=9), or RE+whey protein (EX+PRO; n=9) in a double-blinded fashion. Whole-body RE (2 sets of 8 repetitions and 1 set to volitional failure at 80% 1RM) was performed twice weekly. Supplements (PRO, 25 g whey protein isolate; CON, 23.75 g maltodextrin) were consumed twice daily.
RESULTS


EX+CON and EX+PRO increased leg extension (+19±3 kg and +20±3 kg, respectively) and leg press 1RM (+27±3 kg and +39±2 kg, respectively) greater than the CON and PRO groups (P<0.001, Cohen's d=1.50-1.90). RE (EX+CON and EX+PRO groups pooled) also increased fat-free mass (FFM) (+0.9±0.3 kg) and 6-min walk test distance (+21±5 m) and decreased fat mass (-0.4±0.4 kg), and interleukin-6 (-1.0±0.4 pg/mL) and tumor necrosis factor-alpha concentration (-0.7±0.3 pg/mL) greater than non-exercise (CON and PRO groups pooled; P<0.05, Cohen's f=0.37-0.45). Whey protein supplementation (PRO and EX+PRO groups pooled) increased 4-m gait speed greater than control (CON and EX+CON groups pooled) (+0.08±0.03 m/s; P=0.007, f=0.51).
CONCLUSION


RE increased muscle strength, FFM and physical function, and decreased markers of systemic inflammation in healthy active older men. Whey protein supplementation alone increased gait speed. No synergistic effects were observed. This study was registered at clinicaltrials.gov as NCT03299972.",2022,"CONCLUSION


RE increased muscle strength, FFM and physical function, and decreased markers of systemic inflammation in healthy active older men.","['older adults', 'healthy active older men', 'Thirty-six healthy older men [(mean±SE) age: 67±1 y; BMI: 25.5±0.4\xa0kg/m 2 ']","['placebo', 'Whey protein supplementation (PRO and EX+PRO', 'Whey protein supplementation', 'resistance exercise and whey protein supplementation', 'control (CON; n=9), whey protein (PRO; n=9), RE+control (EX+CON; n=9), or RE+whey protein (EX+PRO', 'maltodextrin', 'RE (EX+CON and EX+PRO', 'resistance exercise (RE) and whey protein supplementation']","['gait speed', '4-m gait speed', 'synergistic effects', 'leg extension', 'tumor necrosis factor-alpha concentration', 'fat-free mass (FFM) ', 'skeletal muscle strength, mass, physical function, and hormonal and inflammatory biomarkers', 'muscle strength, FFM and physical function', 'skeletal muscle strength (primary outcome), mass and physical function, and hormonal and inflammatory biomarkers', '6-min walk test distance (+21±5\xa0m) and decreased fat mass', 'leg press 1RM']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",36.0,0.154683,"CONCLUSION


RE increased muscle strength, FFM and physical function, and decreased markers of systemic inflammation in healthy active older men.","[{'ForeName': 'Corbin', 'Initials': 'C', 'LastName': 'Griffen', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Research Institute of Health and Wellbeing, Coventry University, Coventry, CV1 2DS, United Kingdom; Human Metabolism Research Unit, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, CV2 2DX, United Kingdom. Electronic address: griffenc@uni.coventry.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Duncan', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Research Institute of Health and Wellbeing, Coventry University, Coventry, CV1 2DS, United Kingdom; School of Life Sciences, Faculty of Health and Life Sciences, Coventry University, Coventry, CV1 2DS, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hattersley', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Research Institute of Health and Wellbeing, Coventry University, Coventry, CV1 2DS, United Kingdom; Human Metabolism Research Unit, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, CV2 2DX, United Kingdom; School of Engineering, University of Warwick, Coventry, CV4 7HL, United Kingdom.'}, {'ForeName': 'Martin O', 'Initials': 'MO', 'LastName': 'Weickert', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Research Institute of Health and Wellbeing, Coventry University, Coventry, CV1 2DS, United Kingdom; Department of Endocrinology and Diabetes, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, CV2 2DX, United Kingdom; Warwick Medical School, University of Warwick, Coventry, CV4 7AL, United Kingdom.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Dallaway', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Research Institute of Health and Wellbeing, Coventry University, Coventry, CV1 2DS, United Kingdom; Human Metabolism Research Unit, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, CV2 2DX, United Kingdom.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Renshaw', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Research Institute of Health and Wellbeing, Coventry University, Coventry, CV1 2DS, United Kingdom.'}]",Experimental gerontology,['10.1016/j.exger.2021.111651']
1569,34973303,Effect of continuous intra-incisional bupivacaine on postoperative pain in non-traumatic spinal fixation surgeries: a randomized controlled trial.,"BACKGROUND


Continuous injection of local anesthetics by using surgical wound catheters for postoperative pain relief has gained acceptance in recent years. However, whether this method can be alternatively used instead of systemic opioids in different surgical procedures has not yet been elucidated.
OBJECTIVES


The aim was to investigate the effect of continuous injection of bupivacaine through a catheter inside the surgical wound on reducing the postoperative pain of lumbar spine fusion surgeries.
METHODS


In this clinical trial, 31 patients undergoing non-traumatic lumbar spine stabilization surgery were randomly assigned to receive (n = 15) or do not receive (n = 16) bupivacaine through a catheter inside the surgical wound, postoperatively. Pain intensity (NRS), dose of required morphine, and drug-related complications within 24 hours of intervention were assessed and compared by the Mann-Whitney and independent t-test.
RESULTS


Mean pain intensity was significantly lower in the case group over the first postoperative hour in the recovery room (p < 0.001), which continued for the first 2 hours after entering the ward. The mean morphine intake was lower in the bupivacaine group during the first postoperative 24 hours (16 ± 0.88 vs. 7.33 ± 0.93 mg, p < 0.001). The two groups were not significantly different regarding drug-related complications.
CONCLUSION


Continuous intra-incisional infusion of bupivacaine helped better pain reduction during the early postoperative hours while sparing morphine consumption in the first postoperative day.",2021,"Mean pain intensity was significantly lower in the case group over the first postoperative hour in the recovery room (p < 0.001), which continued for the first 2 hours after entering the ward.","['31 patients undergoing non-traumatic lumbar spine stabilization surgery', 'non-traumatic spinal fixation surgeries']","['continuous intra-incisional bupivacaine', 'bupivacaine']","['postoperative pain', 'Mean pain intensity', 'Pain intensity (NRS), dose of required morphine, and drug-related complications', 'mean morphine intake', 'pain reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",31.0,0.123687,"Mean pain intensity was significantly lower in the case group over the first postoperative hour in the recovery room (p < 0.001), which continued for the first 2 hours after entering the ward.","[{'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Jowkar', 'Affiliation': 'Shiraz University of Medical Sciences, Anesthesiology and Critical Care Research Center, Shiraz, Iran. Electronic address: sjowkar@gmail.com.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Farbood', 'Affiliation': 'Shiraz University of Medical Sciences, Anesthesiology and Critical Care Research Center, Shiraz, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Amini', 'Affiliation': 'Shiraz University of Medical Sciences, Anesthesiology and Critical Care Research Center, Shiraz, Iran.'}, {'ForeName': 'Saman', 'Initials': 'S', 'LastName': 'Asadi', 'Affiliation': 'Shiraz University of Medical Sciences, Anesthesiology and Critical Care Research Center, Shiraz, Iran.'}, {'ForeName': 'Babak Pourabbas', 'Initials': 'BP', 'LastName': 'Tahvildari', 'Affiliation': 'Shiraz University of Medical Sciences, Department of Orthopedics, Shiraz, Iran.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Eghbal', 'Affiliation': 'Shiraz University of Medical Sciences, Department of Neurosurgery, Shiraz, Iran.'}, {'ForeName': 'Naeimehossadat', 'Initials': 'N', 'LastName': 'Asmarian', 'Affiliation': 'Shiraz University of Medical Sciences, Anesthesiology and Critical Care Research Center, Shiraz, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Parvin', 'Affiliation': 'Shiraz University of Medical Sciences, Anesthesiology and Critical Care Research Center, Shiraz, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Zare', 'Affiliation': 'Shiraz University of Medical Sciences, Laparoscopy Research Center, Shiraz, Iran.'}]",Brazilian journal of anesthesiology (Elsevier),['10.1016/j.bjane.2021.12.007']
1570,34907064,Physiotherapy and combined cognitive-behavioural therapy for patients with chronic pelvic pain syndrome: results of a non-randomised controlled feasibility trial.,"OBJECTIVE


To explore feasibility in terms of delivering and evaluating a combination of physiotherapy and psychotherapy for patients with chronic pelvic pain syndrome (CPPS).
DESIGN


Prospective non-randomised controlled pilot study.
SETTING


Tertiary care facility with a specialised interdisciplinary outpatient clinic for patients with CPPS.
PARTICIPANTS


A total of 311 patients was approached; 60 participated. 36 patients were included in the intervention group (mean age ±SD 48.6 years±14.8; 52.8% female) and 24 in the control group (mean age ±SD 50.6 years±14.5; 58.3% female). Fourteen participants were lost to follow-up.
INTERVENTIONS


Participants were non-randomly allocated to the intervention group with two consecutive treatment modules (physiotherapy and cognitive behavioural therapy) with a duration of 9 weeks each or to the control group (treatment as usual).
MAIN OUTCOME MEASURES


Feasibility was operationalised in terms of delivering and evaluating the therapeutic combination. Regarding eligibility as the first aspect of feasibility, willingness to participate, dropout and satisfaction were assessed; for the second aspect, standardised self-report questionnaires measuring health-related quality of life, depression severity and pain were applied.
RESULTS


Although eligibility and willingness-to-participate rates were low, satisfaction of the participants in the intervention group was high and dropout rates were low. Results indicated a small and non-significant intervention effect in health-related quality of life and significant effects regarding depression severity and pain.
CONCLUSIONS


The combination of physiotherapy and psychotherapy for patients with CPPS seems to be feasible and potentially promising with regard to effect. However, a subsequent fully powered randomised controlled trial is needed.
TRIAL REGISTRATION NUMBER


German Clinical Trials Register (DRKS00009976) and ISRCTN (ISRCTN43221600).",2021,"Results indicated a small and non-significant intervention effect in health-related quality of life and significant effects regarding depression severity and pain.
","['36 patients were included in the intervention group (mean age ±SD 48.6 years±14.8; 52.8% female) and 24 in the control group (mean age ±SD 50.6 years±14.5; 58.3% female', 'Fourteen participants were lost to follow-up', 'patients with chronic pelvic pain syndrome', 'patients with chronic pelvic pain syndrome (CPPS', 'patients with CPPS', 'Tertiary care facility with a specialised interdisciplinary outpatient clinic for patients with CPPS', 'A total of 311 patients was approached; 60 participated']","['physiotherapy and psychotherapy', 'Physiotherapy and combined cognitive-behavioural therapy', 'intervention group with two consecutive treatment modules (physiotherapy and cognitive behavioural therapy']","['health-related quality of life', 'depression severity and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C1536168', 'cui_str': 'Chronic pelvic pain syndrome'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",311.0,0.0354301,"Results indicated a small and non-significant intervention effect in health-related quality of life and significant effects regarding depression severity and pain.
","[{'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Brünahl', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany c.bruenahl.ext@uke.de.'}, {'ForeName': 'Susanne G R', 'Initials': 'SGR', 'LastName': 'Klotz', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Dybowski', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Albrecht', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Höink', 'Affiliation': 'Department of Gynaecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Fisch', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Gesche', 'Initials': 'G', 'LastName': 'Ketels', 'Affiliation': 'Department of Physiotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Löwe', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2021-053421']
1571,34882608,Effect of a Novel Omega-3 and Omega-6 Fatty Acid Supplement on Dry Eye Disease: A 3-month Randomized Controlled Trial.,"SIGNIFICANCE


Supplementing diet with a novel combination of omega-3 and omega-6 fatty acids significantly improved symptoms in extremely symptomatic participants with dry eye disease (DED).
PURPOSE


This study aimed to determine the effect of daily intake of a novel combination of essential fatty acids on signs and symptoms of DED.
METHODS


Participants with moderate to severe DED were enrolled in a prospective, randomized, double-masked parallel group study. Participants ingested either the treatment supplement containing omega-3 and omega-6 fatty acids (1200 mg eicosapentaenoic acid, 300 mg docosahexaenoic acid, 150 mg γ-linoleic acid) or the placebo (coconut and olive oil) daily for 3 months. To determine compliance, Omega-3 Index blood tests were conducted. At baseline and at 1 and 3 months, the following assessments were conducted: Ocular Surface Disease Index (OSDI) questionnaire and Symptom Assessment Questionnaire in Dry Eye, noninvasive tear breakup time, tear meniscus height, tear osmolarity, ocular redness, surface staining, Schirmer test, and meibography.
RESULTS


Fifty participants (mean ± standard deviation baseline OSDI score, 52.2 ± 16.5) completed the study: 24 randomized to treatment and 26 randomized to placebo. Although there was an improvement in OSDI score at 3 months for both groups (treatment: -13.4 points, P = .003; placebo: -7.8 points, P = .02), participants with baseline OSDI scores >52 demonstrated an even larger significant improvement in symptoms with the treatment at 3 months compared with baseline (n = 13, -20.8 points, P = .002). There were no significant changes in any of the ocular assessments at 1 or 3 months (all P > .05). After 3 months, Omega-3 Index increased by 34% in the treatment group (baseline, 5.3 ± 0.8; 3 months, 8.0 ± 2.1; P < .001) and did not change in the placebo group (baseline, 4.8 ± 0.8; 3 months, 4.8 ± 0.6; P = .95).
CONCLUSIONS


Supplementation with eicosapentaenoic acid, docosahexaenoic acid, and γ-linoleic acid resulted in a significant and clinically meaningful improvement of dry eye symptoms in extremely symptomatic participants with DED (OSDI ≥52).",2022,There were no significant changes in any of the ocular assessments at 1 or 3 months (all P > .05).,"['extremely symptomatic participants with dry eye disease (DED', 'Participants with moderate to severe DED', 'extremely symptomatic participants with DED (OSDI ≥52', 'Fifty participants (mean ± standard deviation baseline OSDI score, 52.2 ± 16.5) completed the study: 24 randomized to treatment and 26 randomized to', 'Dry Eye Disease']","['placebo', 'omega-3 and omega-6 fatty acids (1200 mg eicosapentaenoic acid, 300 mg docosahexaenoic acid, 150 mg γ-linoleic acid) or the placebo (coconut and olive oil', 'Novel Omega-3 and Omega-6 Fatty Acid Supplement', 'omega-3 and omega-6 fatty acids', 'eicosapentaenoic acid, docosahexaenoic acid, and γ-linoleic acid', 'novel combination of essential fatty acids']","['OSDI score', 'Omega-3 Index', 'ocular assessments', 'Ocular Surface Disease Index (OSDI) questionnaire and Symptom Assessment Questionnaire in Dry Eye, noninvasive tear breakup time, tear meniscus height, tear osmolarity, ocular redness, surface staining, Schirmer test, and meibography']","[{'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517801', 'cui_str': '52.2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0133860', 'cui_str': 'Fatty Acids, Omega-6'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0009210', 'cui_str': 'Cocos nucifera'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0015686', 'cui_str': 'Fatty Acids, Essential'}]","[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}]",,0.697754,There were no significant changes in any of the ocular assessments at 1 or 3 months (all P > .05).,"[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Ng', 'Affiliation': ''}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Woods', 'Affiliation': 'Centre for Ocular Research & Education (CORE), University of Waterloo School of Optometry & Vision Science, Waterloo, Ontario, Canada.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Jahn', 'Affiliation': ""Nature's Way Canada, Dartmouth, Nova Scotia, Canada.""}, {'ForeName': 'Lyndon W', 'Initials': 'LW', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Sullivan Ritter', 'Affiliation': ""Nature's Way Canada, Dartmouth, Nova Scotia, Canada.""}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001826']
1572,34972091,National randomized clinical trial on subdural drainage time after chronic subdural hematoma evacuation.,"OBJECTIVE


Placement of a subdural drain reduces recurrence and death after evacuation of chronic subdural hematoma (CSDH), but little is known about optimal drainage duration. In the present national trial, the authors investigated the effect of drainage duration on recurrence and death.
METHODS


In a randomized controlled trial involving all neurosurgical departments in Denmark, patients treated with single burr hole evacuation of CSDH were randomly assigned to 24 hours or 48 hours of postoperative passive subdural drainage. Follow-up duration was 90 days, and the primary study outcome was recurrent hematoma requiring reoperation. Secondary outcome was death. In addition, complications and length of hospital stay were recorded and analyzed.
RESULTS


Of the 420 included patients, 212 were assigned 24-hour drainage and 208 were assigned 48-hour drainage. The recurrence rate was 14% in the 24-hour group and 13% in the 48-hour group. Four patients died in the 24-hour group, and 8 patients died in the 48-hour group; this difference was not statistically significant. The ORs (95% CIs) for recurrence and mortality (48 hours vs 24 hours) were 0.94 (0.53-1.66) and 2.07 (0.64-7.85), respectively, in the intention-to-treat analysis. The ORs (95% CIs) for recurrence and mortality per 1-hour increase in drainage time were 1.0005 (0.9770-1.0244) and 1.0046 (0.9564-1.0554), respectively, in the as-treated sensitivity analysis that used the observed drainage times instead of the preassigned treatment groups. The rates of surgical and drain-related complications, postoperative infections, and thromboembolic events were not different between groups. The mean ± SD postoperative length of hospital stay was 7.4 ± 4.3 days for patients who received 24-hour drainage versus 8.4 ± 4.9 days for those who received 48-hour drainage (p = 0.14). The mean ± SD postoperative length of stay in the neurosurgical department was significantly shorter for the 24-hour group (2 ± 0.9 days vs 2.8 ± 1.6 days, p < 0.001).
CONCLUSIONS


No significant differences in the rates of recurrent hematoma or death during 90-day follow-up were identified between the two groups that randomly received either 24- or 48-hour passive subdural drainage after burr hole evacuation of CSDH.",2021,No significant differences in the rates of recurrent hematoma or death during 90-day follow-up were identified between the two groups that randomly received either 24- or 48-hour passive subdural drainage after burr hole evacuation of CSDH.,"['chronic subdural hematoma (CSDH', 'Of the 420 included patients', 'chronic subdural hematoma evacuation', 'all neurosurgical departments in Denmark, patients treated with single burr hole evacuation of CSDH']",['postoperative passive subdural drainage'],"['recurrence rate', 'recurrence and mortality per 1-hour increase in drainage time', 'rates of recurrent hematoma or death', 'rates of surgical and drain-related complications, postoperative infections, and thromboembolic events', 'mean ± SD postoperative length of stay in the neurosurgical department', 'death', 'mean ± SD postoperative length of hospital stay', 'recurrence and mortality', 'recurrent hematoma requiring reoperation', 'complications and length of hospital stay']","[{'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0587523', 'cui_str': 'Neurosurgical department'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040836', 'cui_str': 'Trephination of cranium'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038541', 'cui_str': 'Subdural space structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0587523', 'cui_str': 'Neurosurgical department'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]",420.0,0.168876,No significant differences in the rates of recurrent hematoma or death during 90-day follow-up were identified between the two groups that randomly received either 24- or 48-hour passive subdural drainage after burr hole evacuation of CSDH.,"[{'ForeName': 'Thorbjørn Søren Rønn', 'Initials': 'TSR', 'LastName': 'Jensen', 'Affiliation': '1Department of Neurosurgery, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Haldrup', 'Affiliation': '3Department of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Hjortdal Grønhøj', 'Affiliation': '2Department of Neurosurgery, Odense University Hospital and BRIDGE (Brain Research-Inter Disciplinary Guided Excellence), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Rares', 'Initials': 'R', 'LastName': 'Miscov', 'Affiliation': '4Department of Neurosurgery, Aalborg University Hospital, Aalborg, Denmark; and.'}, {'ForeName': 'Carl Christian', 'Initials': 'CC', 'LastName': 'Larsen', 'Affiliation': '1Department of Neurosurgery, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Debrabant', 'Affiliation': '5Epidemiology, Biostatistics and Biodemography, Department of Public Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Frantz Rom', 'Initials': 'FR', 'LastName': 'Poulsen', 'Affiliation': '2Department of Neurosurgery, Odense University Hospital and BRIDGE (Brain Research-Inter Disciplinary Guided Excellence), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Bergholt', 'Affiliation': '3Department of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Hundsholt', 'Affiliation': '4Department of Neurosurgery, Aalborg University Hospital, Aalborg, Denmark; and.'}, {'ForeName': 'Carsten Reidies', 'Initials': 'CR', 'LastName': 'Bjarkam', 'Affiliation': '4Department of Neurosurgery, Aalborg University Hospital, Aalborg, Denmark; and.'}, {'ForeName': 'Kåre', 'Initials': 'K', 'LastName': 'Fugleholm', 'Affiliation': '1Department of Neurosurgery, Rigshospitalet, Copenhagen, Denmark.'}]",Journal of neurosurgery,['10.3171/2021.10.JNS211608']
1573,34904798,Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma.,"BACKGROUND


Patient outcomes are poor for aggressive B-cell non-Hodgkin's lymphomas not responding to or progressing within 12 months after first-line therapy. Tisagenlecleucel is an anti-CD19 chimeric antigen receptor T-cell therapy approved for diffuse large B-cell lymphoma after at least two treatment lines.
METHODS


We conducted an international phase 3 trial involving patients with aggressive lymphoma that was refractory to or progressing within 12 months after first-line therapy. Patients were randomly assigned to receive tisagenlecleucel with optional bridging therapy (tisagenlecleucel group) or salvage chemotherapy and autologous hematopoietic stem-cell transplantation (HSCT) (standard-care group). The primary end point was event-free survival, defined as the time from randomization to stable or progressive disease at or after the week 12 assessment or death. Crossover to receive tisagenlecleucel was allowed if a defined event occurred at or after the week 12 assessment. Other end points included response and safety.
RESULTS


A total of 322 patients underwent randomization. At baseline, the percentage of patients with high-grade lymphomas was higher in the tisagenlecleucel group than in the standard-care group (24.1% vs. 16.9%), as was the percentage with an International Prognostic Index score (range, 0 to 5, with higher scores indicating a worse prognosis) of 2 or higher (65.4% vs. 57.5%). A total of 95.7% of the patients in the tisagenlecleucel group received tisagenlecleucel; 32.5% of the patients in the standard-care group received autologous HSCT. The median time from leukapheresis to tisagenlecleucel infusion was 52 days. A total of 25.9% of the patients in the tisagenlecleucel group had lymphoma progression at week 6, as compared with 13.8% of those in the standard-care group. The median event-free survival in both groups was 3.0 months (hazard ratio for event or death in the tisagenlecleucel group, 1.07; 95% confidence interval, 0.82 to 1.40; P = 0.61). A response occurred in 46.3% of the patients in the tisagenlecleucel group and in 42.5% in the standard-care group. Ten patients in the tisagenlecleucel group and 13 in the standard-care group died from adverse events.
CONCLUSIONS


Tisagenlecleucel was not superior to standard salvage therapy in this trial. Additional studies are needed to assess which patients may obtain the most benefit from each approach. (Funded by Novartis; BELINDA ClinicalTrials.gov number, NCT03570892.).",2022,"The median event-free survival in both groups was 3.0 months (hazard ratio for event or death in the tisagenlecleucel group, 1.07; 95% confidence interval, 0.82 to 1.40; P = 0.61).","['patients with aggressive lymphoma that was refractory to or progressing within 12 months after first-line therapy', '322 patients underwent randomization']","['autologous HSCT', 'tisagenlecleucel with optional bridging therapy (tisagenlecleucel group) or salvage chemotherapy and autologous hematopoietic stem-cell transplantation (HSCT) (standard-care group', 'tisagenlecleucel']","['event-free survival, defined as the time from randomization to stable or progressive disease at or after the week 12 assessment or death', 'International Prognostic Index score', 'percentage of patients with high-grade lymphomas', 'median event-free survival', 'lymphoma progression', 'response and safety', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C3640939', 'cui_str': 'tisagenlecleucel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079740', 'cui_str': 'Lymphoma, High-Grade'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",322.0,0.155387,"The median event-free survival in both groups was 3.0 months (hazard ratio for event or death in the tisagenlecleucel group, 1.07; 95% confidence interval, 0.82 to 1.40; P = 0.61).","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Bishop', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dickinson', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Purtill', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Barba', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Hamad', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sureda', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thieblemont', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morschhauser', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Janz', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Flinn', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Rabitsch', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Yok-Lam', 'Initials': 'YL', 'LastName': 'Kwong', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Marie J', 'Initials': 'MJ', 'LastName': 'Kersten', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Monique C', 'Initials': 'MC', 'LastName': 'Minnema', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Holte', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Esther H L', 'Initials': 'EHL', 'LastName': 'Chan', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Martinez-Lopez', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Antonia M S', 'Initials': 'AMS', 'LastName': 'Müller', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Maziarz', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'McGuirk', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Bachy', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Le Gouill', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dreyling', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Harigae', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bond', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Andreadis', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McSweeney', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Kharfan-Dabaja', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Newsome', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Degtyarev', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Awasthi', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Del Corral', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Andreola', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Masood', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Schuster', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Jäger', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Borchmann', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Westin', 'Affiliation': ""From the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (M. Dickinson), Fiona Stanley Hospital, Murdoch, WA (D.P.), and the Department of Haematology, St. Vincent's Hospital Sydney, and St. Vincent's Clinical School, University of New South Wales, Sydney (N.H.) - all in Australia; Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona (P. Barba) and the Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet de Llobregat (A. Sureda), Barcelona, and the Hematology Department, Hospital 12 de Octubre, Complutense University, Instituto de Investigación Hospital 12 de Octubre, Centro Nacional de Investigaciones Oncológicas, Madrid (J.M.-L.) - all in Spain; the Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital-Humanitas Cancer Center, Milan (A. Santoro); the Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (K.K.), and Tohoku University Hospital, Sendai (H. Harigae) - both in Japan; the Third Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials and Cancer Cluster Salzburg, Salzburg (R.G.), and Internal Medicine I, Bone Marrow Transplant Unit (W.R.), and the Clinical Division of Hematology and Hemostaseology, Department of Medicine I (U.J.), Vienna General Hospital-Medical University of Vienna, Vienna - both in Austria; Assistance Publique-Hôpitaux de Paris, Hemato-Oncology, Hôpital Saint-Louis, Paris (C.T.), Centre Hospitalier Régional Universitaire de Lille, Lille (F.M.), Hospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon (E.B.), and Centre de Recherche en Cancérologie et Immunologie Nantes-Angers, INSERM, and Nantes Medical University, Nantes (S.L.G.) - all in France; the Department of Hematology, Oncology, and Tumorimmunology, Charité-University Hospital Berlin, Campus Benjamin Franklin, and the Experimental and Clinical Research Center of the Max Delbrück Center for Molecular Medicine and Charité Berlin, Berlin (M.J.), Medizinische Klinik III, LMU Klinikum, Munich (M. Dreyling), and Clinic I for Internal Medicine, University Hospital Cologne, Cologne (P. Borchmann) - all in Germany; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (I.F., P.M.); the Department of Medicine, Queen Mary Hospital, Hong Kong (Y.-L.K.); the Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam (M.J.K.), and Universitair Medisch Centrum Utrecht, Department of Medical Oncology, Utrecht (M.C.M.) - both in the Netherlands; the Department of Oncology, Oslo University Hospital, and K.G. Jebsen Center for B-Cell Malignancies - both in Oslo (H. Holte); the National University Cancer Institute Singapore, Singapore (E.H.L.C.); the Department of Medical Oncology and Hematology, University Hospital, Zurich (A.M.S.M.), and Novartis Pharma, Basel (S.N., E.D., G.A.) - both in Switzerland; the Center for Hematologic Malignancies, Knight Cancer Institute, Oregon Health and Science University, Portland (R.T.M.); the Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer Center, Westwood (J.P.M.); Ohio State University, Columbus (D.B.); Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco (C.A.); the Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, FL (M.K.-D.); Novartis Pharmaceuticals, East Hanover, NJ (R.A., C.C., A.M.); the Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia (S.J.S.); and the Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston (J.R.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa2116596']
1574,34871782,Smartphone-based counseling and support platform and the effect on postpartum lactation: a randomized controlled trial.,"BACKGROUND


Human milk lactation provides health benefits for both the mother and infant. Patients commonly report stopping breastfeeding sooner than they planned. Interventions with proper accessible counseling and support to the mother can potentially increase lactation rates and duration.
OBJECTIVE


This study aimed to investigate the impact of introducing a smartphone-based daily feedback and counseling platform between women after delivery and a multidisciplinary lactation support team on lactation rates and various maternal and neonatal outcomes. Counseling was provided via a specifically developed application from a multidisciplinary team (obstetricians, nurses, lactation counselors, and psychologist) in an attempt to assist and counsel to maintain lactation.
STUDY DESIGN


This was a prospective, single-center, randomized controlled trial. Women planning to lactate were recruited at postpartum day 1 and were randomized to (1) routine lactation counseling and support (control group) or (2) additional daily detailed counseling and feedback on lactation from the team via the application (App group). The primary outcome was partial or full lactation at 3 months after delivery. The secondary outcomes included lactation at additional time points up to 6 months after delivery. The study was adequately powered to detect a 15% difference in the primary outcome.
RESULTS


A total of 197 patients were recruited, 97 in the App group and 100 in the control group. The 2 groups did not differ in any background or delivery characteristics. The App group showed higher rates of lactation 6 weeks after delivery (96.9% vs 82.0%; P<.001) and 3 months after delivery (81.4% vs 69.0%; P=.049) than the control group. Patients in the App group reported excellent satisfaction from the use of the application and their overall postnatal care.
CONCLUSION


Our study has provided further information on the growing efficacy of technology platforms in obstetrical care. The introduction of a smartphone-based daily feedback and counseling platform between postpartum patients and a multidisciplinary lactation support team increased the lactation rates after delivery with excellent patient satisfaction.",2022,The App group showed higher rates of lactation 6 weeks after delivery (96.9% vs 82.0%; P<.001) and 3 months after delivery (81.4% vs 69.0%; P=.049) than the control group.,"['Women planning to lactate were recruited at postpartum day 1', 'A total of 197 patients were recruited, 97 in the App group and 100 in the control group']","['Smartphone-based counseling and support platform', 'routine lactation counseling and support (control group) or (2) additional daily detailed counseling and feedback on lactation from the team via the application (App group', 'smartphone-based daily feedback and counseling platform']","['lactation rates and various maternal and neonatal outcomes', 'postpartum lactation', 'lactation at additional time points up to 6 months after delivery', 'higher rates of lactation 6 weeks after delivery', 'lactation rates', 'excellent satisfaction', 'partial or full lactation', 'lactation rates and duration']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0418914', 'cui_str': 'Breastfeeding education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",197.0,0.217783,The App group showed higher rates of lactation 6 weeks after delivery (96.9% vs 82.0%; P<.001) and 3 months after delivery (81.4% vs 69.0%; P=.049) than the control group.,"[{'ForeName': 'Hadas', 'Initials': 'H', 'LastName': 'Miremberg', 'Affiliation': 'Department of Obstetrics and Gynecology, The Edith Wolfson Medical Center, Holon, Israel; Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel. Electronic address: dasile2@gmail.com.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Yirmiya', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat Gan, Israel; Interdisciplinary Center, Herzliya, Israel.'}, {'ForeName': 'Shiran', 'Initials': 'S', 'LastName': 'Rona', 'Affiliation': 'Department of Obstetrics and Gynecology, The Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Gonen', 'Affiliation': 'Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Or', 'Initials': 'O', 'LastName': 'Marom', 'Affiliation': 'Department of Obstetrics and Gynecology, The Edith Wolfson Medical Center, Holon, Israel; Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Pohol', 'Affiliation': 'Department of Obstetrics and Gynecology, The Edith Wolfson Medical Center, Holon, Israel; Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kovo', 'Affiliation': 'Department of Obstetrics and Gynecology, The Edith Wolfson Medical Center, Holon, Israel; Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bar', 'Affiliation': 'Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Weiner', 'Affiliation': 'Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2021.100543']
1575,34954448,A randomized control trial of Expand Your Horizon: An intervention for women with weight bias internalization.,"Weight bias internalization (WBI) is associated with a myriad of negative health outcomes, but there are few effective treatments that address this concern. This randomized controlled trial examined the preliminary effectiveness of a previously developed body gratitude journaling intervention (i.e., Expand Your Horizon) compared with an active control writing condition (i.e., expressive writing) in emerging adult women with WBI. Participants (N = 135) completed baseline measures and were then randomized to either Expand Your Horizon (n = 72) or the active control condition (n = 63). Participants in both conditions completed three writing tasks over one week. Assessments occurred at baseline, post-test, and follow-up (one-week). Participants in both conditions experienced improvements in WBI, functionality appreciation, and self-compassion at follow-up, though improvements were greater in the Expand Your Horizon condition. Further, participants in the Expand Your Horizon had greater improvement in healthcare stress at follow-up. In sum, Expand Your Horizon appeared accessible and demonstrated preliminary effectiveness in a sample of emerging adult women with WBI. Avenues for future research include evaluating this intervention in more diverse populations with a longer follow-up.",2022,"Participants in both conditions experienced improvements in WBI, functionality appreciation, and self-compassion at follow-up, though improvements were greater in the Expand Your Horizon condition.","['women with weight bias internalization', 'adult women with WBI']","['Your Horizon', 'active control writing condition (i.e., expressive writing', 'body gratitude journaling intervention (i.e., Expand Your Horizon']","['WBI, functionality appreciation, and self-compassion', 'healthcare stress']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",135.0,0.169724,"Participants in both conditions experienced improvements in WBI, functionality appreciation, and self-compassion at follow-up, though improvements were greater in the Expand Your Horizon condition.","[{'ForeName': 'Alexandria E', 'Initials': 'AE', 'LastName': 'Davies', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, P.O. Box 842018, Richmond, VA 23284-2018, USA. Electronic address: daviesae@vcu.edu.'}, {'ForeName': 'C Blair', 'Initials': 'CB', 'LastName': 'Burnette', 'Affiliation': 'Department of Public Health, University of Minnesota, Minneapolis, MN 55454, USA.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Ravyts', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, P.O. Box 842018, Richmond, VA 23284-2018, USA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mazzeo', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, P.O. Box 842018, Richmond, VA 23284-2018, USA.'}]",Body image,['10.1016/j.bodyim.2021.12.006']
1576,34880029,Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP Study).,"INTRODUCTION


Primary angle-closure glaucoma (PACG) has a high prevalence and blinding rate across Asia. The first-line treatment of PACG is surgery, and phacotrabeculectomy remains the mainstream surgery for advanced PACG. However, it may cause vision-threatening complications with long learning curve. Minimally invasive glaucoma surgery has been gradually used in PACG combined with cataract surgery and achieved efficacy without excessive injury, of which goniotomy is the most commonly performed. Therefore, this study aimed to conduct a multicentre, non-inferiority randomised controlled clinical trial to compare the efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced PACG.
METHODS AND ANALYSIS


This is a non-inferiority multicentre randomised controlled trial and will be conducted at eight ophthalmic departments and institutes in China. 124 patients with advanced PACG will be enrolled and randomised to undergo phacotrabeculectomy or phacogoniotomy. Comprehensive ophthalmic examinations will be performed before and after the surgery. The primary outcome is the change of intraocular pressure at 12 months after surgery compared with the baseline intraocular pressure. An extended follow-up period of 36 months will be required. Cumulative success rate of surgery, intraoperative and postoperative complications, and number of anti-glaucomatous medications will also be compared between the groups as secondary outcomes.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from the ethical committee of Zhongshan Ophthalmic Center, Sun Yat-sen University, China (ID: 2021KYPJ090) and all subcentres. All the participants will be required to provide written informed consent. The results will be disseminated through scientific meetings and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT04878458.",2021,"Minimally invasive glaucoma surgery has been gradually used in PACG combined with cataract surgery and achieved efficacy without excessive injury, of which goniotomy is the most commonly performed.","['eight ophthalmic departments and institutes in China', '124 patients with advanced PACG', 'advanced primary angle-closure glaucoma']","['phacotrabeculectomy versus phacogoniotomy', 'phacotrabeculectomy or phacogoniotomy', 'PACG', 'Primary angle-closure glaucoma (PACG']","['Efficacy and safety', 'Cumulative success rate of surgery, intraoperative and postoperative complications, and number of anti-glaucomatous medications', 'efficacy and safety', 'change of intraocular pressure']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0017605', 'cui_str': 'Angle-closure glaucoma'}]","[{'cui': 'C1167708', 'cui_str': 'Phacotrabeculectomy'}, {'cui': 'C0017605', 'cui_str': 'Angle-closure glaucoma'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",124.0,0.668088,"Minimally invasive glaucoma surgery has been gradually used in PACG combined with cataract surgery and achieved efficacy without excessive injury, of which goniotomy is the most commonly performed.","[{'ForeName': 'Yunhe', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Wulian', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Ophthalmology, Harbin Medical University, Harbin, Heilongjiang, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Sichuan University West China Hospital, Chengdu, Sichuan, China.'}, {'ForeName': 'Hengli', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Ophthalmology, Shijiazhuang People's Hospital, Shijiazhuang, Hebei Province, China.""}, {'ForeName': 'Meichun', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Department of Ophthalmology, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.'}, {'ForeName': 'Xiaohuan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Ophthalmology, Shanghai General Hospital, Shanghai, China.'}, {'ForeName': 'Aiguo', 'Initials': 'A', 'LastName': 'Lv', 'Affiliation': 'Handan City Eye Hospital, Handan, China.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': ""Department of Ophthalmology, Shijiazhuang People's Hospital, Shijiazhuang, Hebei Province, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': 'Handan City Eye Hospital, Handan, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Ophthalmology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Xinbo', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yingzhe', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Affliated Hospital of Guizhou Medical University, Guiyang, China.'}, {'ForeName': 'Guangxian', 'Initials': 'G', 'LastName': 'Tang', 'Affiliation': ""Department of Ophthalmology, Shijiazhuang People's Hospital, Shijiazhuang, Hebei Province, China.""}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Department of Ophthalmology, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.'}, {'ForeName': 'Minwen', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Department of Ophthalmology, Shanghai General Hospital, Shanghai, China.'}, {'ForeName': 'Sujie', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Handan City Eye Hospital, Handan, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Department of Ophthalmology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Ophthalmology, Sichuan University West China Hospital, Chengdu, Sichuan, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, Harbin Medical University, Harbin, Heilongjiang, China zhangxl2@mail.sysu.edu.cn yuanhp2013@126.com.'}, {'ForeName': 'Xiulan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, China zhangxl2@mail.sysu.edu.cn yuanhp2013@126.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2021-056876']
1577,34907065,PROphylactic MESH (PROMESH) for stoma closure: does it reduce the incidence of incisional hernia? Protocol for a triple-blinded randomised controlled trial.,"INTRODUCTION


Application of a prophylactic mesh during stoma closure was shown to reduce the incidence of incisional hernia at the site of stoma closure. Our objective is to provide high quality evidence to validate this finding.
METHODS AND ANALYSIS


The study will be a randomised controlled triple-blinded superiority parallel monocentric trial. Patients undergoing elective ileostomy or colostomy closure after surgery for digestive cancer will be eligible for inclusion. Patients allergic to the mesh, immunosuppressed or refusing to participate will be excluded. Randomisation will be performed based on a 1:1 allocation ratio between stoma closure with application of a non-absorbable mesh in the sublay position (intervention) and stoma closure without a mesh (control). The primary outcome will be the 1-year incidence of incisional hernia at the site of stoma closure, determined clinically and by CT. Secondary outcomes will be the 31-day incidence of surgical site infection and the modified Carolinas Comfort Scale. Patients, radiologists and investigators performing the assessment at 1 year will be blinded for the allocated study group. Analysis will be performed in intention-to-treat. The trial will include 68 patients (34 with mesh, 34 without mesh).
ETHICS AND DISSEMINATION


The present randomised controlled trial was registered into clinicaltrials.gov (NCT04510558) and was accepted by the local ethic committee (Geneva, Switzerland: CCER 2021-00053). The results will be presented at national and international congresses in the fields of colorectal surgery and general surgery, and published in a peer-reviewed journal.",2021,"INTRODUCTION


Application of a prophylactic mesh during stoma closure was shown to reduce the incidence of incisional hernia at the site of stoma closure.","['Patients undergoing', 'stoma closure', '68 patients (34 with mesh, 34 without mesh']","['stoma closure with application of a non-absorbable mesh in the sublay position (intervention) and stoma closure without a mesh (control', 'elective ileostomy or colostomy closure', 'PROphylactic MESH (PROMESH']","['incidence of incisional hernia', '31-day incidence of surgical site infection and the modified Carolinas Comfort Scale', '1-year incidence of incisional hernia at the site of stoma closure, determined clinically and by CT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3665863', 'cui_str': 'Stoma closure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}]","[{'cui': 'C3665863', 'cui_str': 'Stoma closure'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0192993', 'cui_str': 'Closure of colostomy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C3665863', 'cui_str': 'Stoma closure'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}]",68.0,0.658419,"INTRODUCTION


Application of a prophylactic mesh during stoma closure was shown to reduce the incidence of incisional hernia at the site of stoma closure.","[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Meyer', 'Affiliation': 'Medical School, University of Geneva, Geneva, Switzerland jeremy.meyer@hcuge.ch.'}, {'ForeName': 'Vaihere', 'Initials': 'V', 'LastName': 'Delaune', 'Affiliation': 'Medical School, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Abbassi', 'Affiliation': 'Medical School, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Douissard', 'Affiliation': 'Medical School, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Toso', 'Affiliation': 'Medical School, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Ris', 'Affiliation': 'Medical School, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Buchs', 'Affiliation': 'Medical School, University of Geneva, Geneva, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2021-053751']
1578,34907057,Supporting Parenting at Home-Empowering Rehabilitation through Engagement (SPHERE): study protocol for a randomised control trial.,"INTRODUCTION


Infants with neurodevelopmental disabilities (NDs) show emotional, cognitive and sociointeractive dysregulation dramatically impacting on caregiving behaviour. Early video-feedback interventions (VFIs) are effective in promoting sensitive parenting, which in turn supports infants' development, even in case of ND. In the light of limited resources of the healthcare systems, technological advances in telemedicine may facilitate the delivery of VFI to a greater number of families of infants with ND. To date, no study has implemented a telemedicine VFI (TVFI) for families of infants diagnosed with ND.
METHODS AND ANALYSIS


The Supporting Parenting at Home-Empowering Rehabilitation through Engagement project is a randomised controlled trial aimed at assessing the effectiveness of an early family-centred TVFI parenting support on dyads with infants diagnosed with ND. It includes two arms (TVFI vs Booklet Psychoeducational Intervention) and three assessment phases: T0, baseline; T1, immediate postintervention; T2, 6-month follow-up.
ETHICS AND DISSEMINATION


This study is funded by the Italian Ministry of Health and was approved by the Ethics Committee (Pavia). Results will be published in peer-reviewed journals and presented at national and international scientific conferences.
TRIAL REGISTRATION NUMBER


The study protocol has been also registered on NIH Clinical Trials (protocol code NCT04656483; Pre-results).",2021,"Early video-feedback interventions (VFIs) are effective in promoting sensitive parenting, which in turn supports infants' development, even in case of ND.","['dyads with infants diagnosed with ND', 'Infants with neurodevelopmental disabilities (NDs', 'families of infants diagnosed with ND']","['early family-centred TVFI parenting support', 'telemedicine VFI (TVFI', 'Early video-feedback interventions (VFIs']",[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.112001,"Early video-feedback interventions (VFIs) are effective in promoting sensitive parenting, which in turn supports infants' development, even in case of ND.","[{'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Grumi', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy serena.grumi@mondino.it.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Borgatti', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Provenzi', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}]",BMJ open,['10.1136/bmjopen-2021-051817']
1579,34968130,"Collaborative, dyadic, and individual planning and physical activity: A dyadic randomized controlled trial.","OBJECTIVE


This study was designed to investigate the effects of collaborative, dyadic, and individual planning on moderate-to-vigorous physical activity (MVPA) in target person-partner dyads. Individual planning reflects an ""I-for-me"" planning of one person's behavior. Collaborative planning refers to joint planning of both dyad members' behavior (""We-for-us"" planning), and dyadic planning refers to joint planning of only the target person's behavior (""We-for-me"" planning).
METHOD


N  = 320 dyads of target persons ( M  age: 43.86 years old) and partners ( M  age: 42.32 years old) participated in a randomized controlled trial (ClinicalTrials.gov registration no. NCT03011385) with three experimental planning conditions (collaborative, dyadic, or individual planning) and an active control condition (physical activity, sedentary behavior, and nutrition education). Target persons did not meet international MVPA guidelines or were recommended to increase their MVPA due to cardiovascular disease or type II diabetes. MVPA was measured with ActiGraph wGT3X-BT accelerometers at baseline, 1-week follow-up, and 36-week follow-up (6 months after the final intervention session; the primary endpoint). Linear mixed models were fit for target persons and partners separately.
RESULTS


At 1-week follow-up, there were no significant Time × Condition interaction effects among target persons and partners. At 36-week follow-up, target persons and partners in the dyadic planning conditions increased their MVPA, compared to the control condition.
CONCLUSIONS


Individuals with insufficient physical activity or with a cardiovascular disease/type II diabetes and their partners may benefit from dyadic planning, which is a promising strategy to achieve physical activity increases. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,"At 36-week follow-up, target persons and partners in the dyadic planning conditions increased their MVPA, compared to the control condition.
","['target person-partner dyads', 'N  = 320 dyads of target persons ( M  age: 43.86 years old) and partners ( M  age: 42.32 years old']","['three experimental planning conditions (collaborative, dyadic, or individual planning) and an active control condition (physical activity, sedentary behavior, and nutrition education']",['moderate-to-vigorous physical activity (MVPA'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0302884,"At 36-week follow-up, target persons and partners in the dyadic planning conditions increased their MVPA, compared to the control condition.
","[{'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Kulis', 'Affiliation': 'Wroclaw Faculty of Psychology.'}, {'ForeName': 'Zofia', 'Initials': 'Z', 'LastName': 'Szczuka', 'Affiliation': 'Wroclaw Faculty of Psychology.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Keller', 'Affiliation': 'Department of Education and Psychology.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Banik', 'Affiliation': 'Wroclaw Faculty of Psychology.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Boberska', 'Affiliation': 'Wroclaw Faculty of Psychology.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Kruk', 'Affiliation': 'Institute of Psychology.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Knoll', 'Affiliation': 'Department of Education and Psychology.'}, {'ForeName': 'Theda', 'Initials': 'T', 'LastName': 'Radtke', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Urte', 'Initials': 'U', 'LastName': 'Scholz', 'Affiliation': 'Department of Psychology, Applied Health and Social Psychology.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Rhodes', 'Affiliation': 'Behavioural Medicine Laboratory.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Luszczynska', 'Affiliation': 'Wroclaw Faculty of Psychology.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0001124']
1580,34968102,Relative effectiveness of general versus specific cognitive training for aging adults.,"In the present study, we examined three experimental cognitive interventions, two targeted at training general cognitive abilities and one targeted at training specific instrumental activities of daily living (IADL) abilities, along with one active control group to compare benefits of these interventions beyond expectation effects, in a group of older adults ( N  = 230). Those engaged in general training did so with either the web-based brain game suite BrainHQ or the strategy video game Rise of Nations, while those trained on IADL skills completed instructional programs on driving and fraud awareness. Active control participants completed sets of puzzles. Comparing baseline and postintervention data across conditions, none of the preregistered primary outcome measures demonstrated a significant interaction between session and intervention condition, indicating no differential benefits. Analysis of expectation effects showed differences between intervention groups consistent with the type of training. Those in the IADL training condition did demonstrate superior knowledge for specific trained information (driving and finances). Twelve months after training, significant interactions between session and intervention were present in the primary measure of fraud detection, as well as the secondary measures of the letter sets task and Rey's Auditory Verbal Learning Test. However, the specific source of these interactions was difficult to discern. At 1-year follow-up those in the IADL condition did not maintain superior knowledge of driving and finances gained through training, as was present immediately postintervention. Hence, the interventions, when compared to an active control condition, failed to show general or specific transfer in a meaningful or consistent way. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,"At 1-year follow-up those in the IADL condition did not maintain superior knowledge of driving and finances gained through training, as was present immediately postintervention.","['aging adults', 'older adults ( N  = 230']",['general versus specific cognitive training'],"[""letter sets task and Rey's Auditory Verbal Learning Test""]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}]",,0.00774183,"At 1-year follow-up those in the IADL condition did not maintain superior knowledge of driving and finances gained through training, as was present immediately postintervention.","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Gray', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jong-Sung', 'Initials': 'JS', 'LastName': 'Yoon', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Charness', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Walter R', 'Initials': 'WR', 'LastName': 'Boot', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Nelson A', 'Initials': 'NA', 'LastName': 'Roque', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Andringa', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Harrell', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Katharine G', 'Initials': 'KG', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vitale', 'Affiliation': 'Department of Psychology.'}]",Psychology and aging,['10.1037/pag0000663']
1581,34967757,Detection of Clenbuterol-Induced Changes in Heart Rate Using At-Home Recorded Smartwatch Data: Randomized Controlled Trial.,"BACKGROUND


Although electrocardiography is the gold standard for heart rate (HR) recording in clinical trials, the increasing availability of smartwatch-based HR monitors opens up possibilities for drug development studies. Smartwatches allow for inexpensive, unobtrusive, and continuous HR estimation for potential detection of treatment effects outside the clinic, during daily life.
OBJECTIVE


The aim of this study is to evaluate the repeatability and sensitivity of smartwatch-based HR estimates collected during a randomized clinical trial.
METHODS


The data were collected as part of a multiple-dose, investigator-blinded, randomized, placebo-controlled, parallel-group study of 12 patients with Parkinson disease. After a 6-day baseline period, 4 and 8 patients were treated for 7 days with an ascending dose of placebo and clenbuterol, respectively. Throughout the study, the smartwatch provided HR and sleep state estimates. The HR estimates were quantified as the 2.5th, 50th, and 97.5th percentiles within awake and asleep segments. Linear mixed models were used to calculate the following: (1) the intraclass correlation coefficient (ICC) of estimated sleep durations, (2) the ICC and minimum detectable effect (MDE) of the HR estimates, and (3) the effect sizes of the HR estimates.
RESULTS


Sleep duration was moderately repeatable (ICC=0.64) and was not significantly affected by study day (P=.83), clenbuterol (P=.43), and study day by clenbuterol (P=.73). Clenbuterol-induced changes were detected in the asleep HR as of the first night (+3.79 beats per minute [bpm], P=.04) and in the awake HR as of the third day (+8.79 bpm, P=.001). The median HR while asleep had the highest repeatability (ICC=0.70). The MDE (N=12) was found to be smaller when patients were asleep (6.8 bpm to 11.7 bpm) than while awake (10.7 bpm to 22.1 bpm). Overall, the effect sizes for clenbuterol-induced changes were higher while asleep (0.49 to 2.75) than while awake (0.08 to 1.94).
CONCLUSIONS


We demonstrated the feasibility of using smartwatch-based HR estimates to detect clenbuterol-induced changes during clinical trials. The asleep HR estimates were most repeatable and sensitive to treatment effects. We conclude that smartwatch-based HR estimates obtained during daily living in a clinical trial can be used to detect and track treatment effects.
TRIAL REGISTRATION


Netherlands Trials Register NL8002; https://www.trialregister.nl/trial/8002.",2021,"Overall, the effect sizes for clenbuterol-induced changes were higher while asleep (0.49 to 2.75) than while awake (0.08 to 1.94).
",['12 patients with Parkinson disease'],"['placebo', 'electrocardiography']","['asleep HR estimates', 'HR estimates', 'intraclass correlation coefficient (ICC) of estimated sleep durations, (2) the ICC and minimum detectable effect (MDE) of the HR estimates, and (3) the effect sizes of the HR estimates', 'asleep HR', 'Sleep duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",12.0,0.117672,"Overall, the effect sizes for clenbuterol-induced changes were higher while asleep (0.49 to 2.75) than while awake (0.08 to 1.94).
","[{'ForeName': 'Willem O', 'Initials': 'WO', 'LastName': 'Elzinga', 'Affiliation': 'Centre for Human Drug Research, Leiden, Netherlands.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Prins', 'Affiliation': 'Centre for Human Drug Research, Leiden, Netherlands.'}, {'ForeName': 'Laura G J M', 'Initials': 'LGJM', 'LastName': 'Borghans', 'Affiliation': 'Centre for Human Drug Research, Leiden, Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Gal', 'Affiliation': 'Centre for Human Drug Research, Leiden, Netherlands.'}, {'ForeName': 'Gabriel A', 'Initials': 'GA', 'LastName': 'Vargas', 'Affiliation': 'CuraSen Therapeutics Inc, San Carlos, CA, United States.'}, {'ForeName': 'Geert J', 'Initials': 'GJ', 'LastName': 'Groeneveld', 'Affiliation': 'Centre for Human Drug Research, Leiden, Netherlands.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Doll', 'Affiliation': 'Centre for Human Drug Research, Leiden, Netherlands.'}]",JMIR formative research,['10.2196/31890']
1582,34982486,Changes in eicosapentaenoic acid and docosahexaenoic acid and risk of cardiovascular events and atrial fibrillation: A secondary analysis of the OMEMI trial.,"BACKGROUND


The cardiovascular benefit from n-3 polyunsaturated fatty acids (PUFAs) after acute myocardial infarction (AMI) is controversial, and the importance of serum eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) concentrations for clinical events is unclear.
OBJECTIVES


To assess changes in EPA and DHA serum concentrations during n-3 PUFA supplementation and their association with incident cardiovascular events.
METHODS


In the OMEMI trial, elderly patients with a recent AMI were randomized to 1.8 g/day of EPA/DHA or control (corn oil) for 2 years. The primary outcome was a composite of AMI, coronary revascularization, stroke, heart failure hospitalization, or all-cause death (major adverse cardiovascular event [MACE]) and the secondary outcome was new-onset atrial fibrillation (AF).
RESULTS


EPA and DHA measurements were available in 881 (92% of survivors) participants at randomization and study completion. EPA and DHA increased in the active treatment arm (n = 438) by a median of 87% and 16%, respectively. Greater on-treatment increases in EPA and DHA were associated with decreasing triglycerides, increasing high-density lipoprotein cholesterol, and lower baseline EPA and DHA concentrations. Greater on-treatment increases in EPA were associated with lower risk of MACE (adjusted hazard ratio 0.86 [95% confidence interval, CI, 0.75-0.99], p = 0.034), and higher risk of AF (adjusted hazard ratio (HR) 1.36 [95% CI 1.07-1.72], p = 0.011). Although there were similar tendencies for DHA changes and outcomes, these associations were not statistically significant (HR 0.84 [0.66-1.06] for MACE and 1.39 [0.90-2.13] for AF).
CONCLUSION


Greater on-treatment increases in EPA were associated with lower risk of MACE and higher risk of new-onset AF. These data suggest that the cardiovascular effects of increasing n-3 PUFA levels through supplements are complex, involving both potential benefits and harm.",2022,"Greater on-treatment increases in EPA were associated with lower risk of MACE (adjusted hazard ratio 0.86 [95% confidence interval, CI, 0.75-0.99], p = 0.034), and higher risk of AF (adjusted hazard ratio (HR) 1.36",['elderly patients with a recent AMI'],"['n-3 PUFA supplementation', 'EPA/DHA or control (corn oil', 'n-3 polyunsaturated fatty acids (PUFAs', 'eicosapentaenoic acid and docosahexaenoic acid']","['cardiovascular events and atrial fibrillation', 'EPA and DHA', 'higher risk of AF', 'composite of AMI, coronary revascularization, stroke, heart failure hospitalization, or all-cause death (major adverse cardiovascular event [MACE]) and the secondary outcome was new-onset atrial fibrillation (AF', 'EPA and DHA serum concentrations', 'EPA', 'triglycerides, increasing high-density lipoprotein cholesterol, and lower baseline EPA and DHA concentrations']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.438666,"Greater on-treatment increases in EPA were associated with lower risk of MACE (adjusted hazard ratio 0.86 [95% confidence interval, CI, 0.75-0.99], p = 0.034), and higher risk of AF (adjusted hazard ratio (HR) 1.36","[{'ForeName': 'Peder L', 'Initials': 'PL', 'LastName': 'Myhre', 'Affiliation': 'Department of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Are A', 'Initials': 'AA', 'LastName': 'Kalstad', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Sjur H', 'Initials': 'SH', 'LastName': 'Tveit', 'Affiliation': 'Department of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Laake', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital and Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Pal', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'Department of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Dennis W T', 'Initials': 'DWT', 'LastName': 'Nilsen', 'Affiliation': 'Department of Cardiology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Arnljot', 'Initials': 'A', 'LastName': 'Tveit', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Solheim', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Arnesen', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ingebjørg', 'Initials': 'I', 'LastName': 'Seljeflot', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}]",Journal of internal medicine,['10.1111/joim.13442']
1583,34916320,Novel longitudinal Multiple Overall Toxicity (MOTox) score to quantify adverse events experienced by patients during chemotherapy treatment: a retrospective analysis of the MRC BO06 trial in osteosarcoma.,"OBJECTIVES


This study aims at exploring and quantifying multiple types of adverse events (AEs) experienced by patients during cancer treatment. A novel longitudinal score to evaluate the Multiple Overall Toxicity (MOTox) burden is proposed. The MOTox approach investigates the personalised evolution of high overall toxicity (high-MOTox) during the treatment.
DESIGN


Retrospective analysis of the MRC-BO06/EORTC-80931 randomised controlled trial for osteosarcoma.
SETTING


International multicentre population-based study.
PARTICIPANTS


A total of 377 patients with resectable high-grade osteosarcoma, who completed treatment within 180 days after randomisation without abnormal dosages (+25% higher than planned).
INTERVENTIONS


Patients were randomised to six cycles of conventional versus dose-intense regimens of doxorubicin and cisplatin. Non-haematological toxicity data were collected prospectively and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
MAIN OUTCOME MEASURES


The MOTox score described the overall toxicity burden in terms of multiple toxic AEs, maximum-severity episode and cycle time-dimension. Evolution of high-MOTox was assessed through multivariable models, that investigated the impact of personalised characteristics (eg, achieved chemotherapy dose, previous AEs or biochemical factors) cycle-by-cycle.
RESULTS


A cycle-by-cycle analysis identifies different evolutions of MOTox levels during treatment, detecting differences in patients' health. Mean MOTox values and percentages of patients with high-MOTox decreased cycle-by-cycle from 2.626 to 1.953 and from 57.8% to 36.6%, respectively. High - MOTox conditions during previous cycles were prognostic risk factors for a new occurrence (ORs range from 1.522 to 4.439), showing that patient's history of toxicities played an important role in the evolution of overall toxicity burden during therapy. Conventional regimen may be preferred to dose-intense in terms of AEs at cycles 2-3 (p<0.05).
CONCLUSIONS


The novel longitudinal method developed can be applied to any cancer studies with CTCAE-graded toxicity data. After validation in other studies, the MOTox approach may lead to improvements in healthcare assessment and treatment planning.
TRIAL REGISTRATION NUMBER


ISRCTN86294690; Post-results.",2021,"High - MOTox conditions during previous cycles were prognostic risk factors for a new occurrence (ORs range from 1.522 to 4.439), showing that patient's history of toxicities played an important role in the evolution of overall toxicity burden during therapy.","['patients during cancer treatment', ""patients' health"", 'A total of 377 patients with resectable high-grade osteosarcoma, who completed treatment within 180 days after randomisation without abnormal dosages (+25% higher than planned', 'patients during chemotherapy treatment: a retrospective analysis of the MRC BO06 trial in osteosarcoma', 'International multicentre population-based study']",['conventional versus dose-intense regimens of doxorubicin and cisplatin'],"['Mean MOTox values', 'Novel longitudinal Multiple Overall Toxicity (MOTox) score', 'MOTox levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",377.0,0.154413,"High - MOTox conditions during previous cycles were prognostic risk factors for a new occurrence (ORs range from 1.522 to 4.439), showing that patient's history of toxicities played an important role in the evolution of overall toxicity burden during therapy.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Spreafico', 'Affiliation': 'MOX, Department of Mathematics, Politecnico di Milano, Milan, Italy marta.spreafico@polimi.it.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ieva', 'Affiliation': 'MOX, Department of Mathematics, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Arlati', 'Affiliation': 'MOX, Department of Mathematics, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Capello', 'Affiliation': 'MOX, Department of Mathematics, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Fatone', 'Affiliation': 'MOX, Department of Mathematics, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Fedeli', 'Affiliation': 'MOX, Department of Mathematics, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Gianmarco', 'Initials': 'G', 'LastName': 'Genalti', 'Affiliation': 'MOX, Department of Mathematics, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Anninga', 'Affiliation': 'Department of Solid Tumors, Princess Máxima Center for Pediatric Oncology, Utrecht, Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Fiocco', 'Affiliation': 'Mathematical Institute, Leiden University, Leiden, Netherlands.'}]",BMJ open,['10.1136/bmjopen-2021-053456']
1584,34871154,Safety of ciclesonide in children with asthma: A review of randomized controlled trials.,"Background:  Parental concerns about the adverse effects of asthma medications can lead to nonadherence and uncontrolled asthma in children. Ciclesonide (CIC) is a prodrug, with low oropharyngeal deposition and bioavailability that may minimize the risk of local and systemic adverse effects. CIC is U.S. Food and Drug Administration approved for asthma in children ages ≥ 12 years.  Objective:  To summarize safety results from the 13 phase II or III randomized controlled trials conducted in children with asthma during CIC clinical development.  Methods:  Four 12- to 24-week trials compared the safety of once-daily CIC 40, 80, or 160 µg/day with placebo; four 12-week trials compared the safety of CIC 80 or 160 µg/day with either fluticasone or budesonide; one 12-month trial compared the long-term safety of CIC 40, 80, or 160 µg/day with fluticasone; one 12-month trial compared growth velocity of CIC 40 or 160 µg/day with placebo; and three cross-over trials compared short-term growth velocity and hypothalamic-pituitary-adrenal (HPA) axis effects of CIC 40, 80, or 160 µg/day with placebo or fluticasone.  Results:  In all, 4399 children were treated with CIC. The incidence of treatment-emergent adverse events (AE) was similar among the CIC doses and between CIC and placebo in short-term studies and between CIC and fluticasone in the long-term safety study. No CIC-related serious AEs were reported in any study. The incidence of treatment-related oral candidiasis was low and similar between CIC (≤0.5%) and placebo (≤0.7%) or active controls (≤0.5%) in the short-term studies. There was no clinically relevant HPA axis suppression or reduction in growth velocity associated with CIC.  Conclusion:  Data from 13 studies demonstrate that CIC is associated with low rates of oropharyngeal AEs, with no indication of clinically relevant systemic effects in children with asthma. The favorable safety profile and demonstrated improvements in asthma control make CIC an ideal inhaled corticosteroid for the treatment of asthma in children.",2021,The incidence of treatment-emergent adverse events (AE) was similar among the CIC doses and between CIC and placebo in short-term studies and between CIC and fluticasone in the long-term safety study.,"['children', 'children with asthma', 'children ages ≥ 12 years', '4399 children were treated with', 'children with asthma during CIC clinical development', 'asthma in children']","['placebo', 'ciclesonide', 'fluticasone', 'Ciclesonide (CIC', 'CIC', 'placebo or fluticasone', 'fluticasone or budesonide']","['incidence of treatment-related oral candidiasis', 'growth velocity and hypothalamic-pituitary-adrenal (HPA) axis effects', 'incidence of treatment-emergent adverse events (AE']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0055670', 'cui_str': 'CHVP protocol'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0907850', 'cui_str': 'ciclesonide'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0055670', 'cui_str': 'CHVP protocol'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006849', 'cui_str': 'Candidiasis of mouth'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",4399.0,0.321236,The incidence of treatment-emergent adverse events (AE) was similar among the CIC doses and between CIC and placebo in short-term studies and between CIC and fluticasone in the long-term safety study.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Blaiss', 'Affiliation': 'From the Department of Pediatrics, Medical College of Georgia at Augusta University, Augusta, Georgia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Berger', 'Affiliation': 'Allergy and Asthma Associates of Southern California, Mission Viejo, California.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Chipps', 'Affiliation': 'Capital Allergy and Respiratory Disease Center, Sacramento, California.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Hernandez-Trujillo', 'Affiliation': 'Department of Pediatrics, Herbert Wertheim School of Medicine, Florida International University, Miami, Florida.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Division of Immunology and Allergy, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts; and.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Steward', 'Affiliation': 'Covis Pharma B.V., Zug, Switzerland.'}]",Allergy and asthma proceedings,['10.2500/aap.2021.42.210085']
1585,34956222,Endogenous Antibody Responses to SARS-CoV-2 in Patients With Mild or Moderate COVID-19 Who Received Bamlanivimab Alone or Bamlanivimab and Etesevimab Together.,"Background


Neutralizing monoclonal antibodies (mAbs) to SARS-CoV-2 are clinically efficacious when administered early, decreasing hospitalization and mortality in patients with mild or moderate COVID-19. We investigated the effects of receiving mAbs (bamlanivimab alone and bamlanivimab and etesevimab together) after SARS-CoV-2 infection on the endogenous immune response.
Methods


Longitudinal serum samples were collected from patients with mild or moderate COVID-19 in the BLAZE-1 trial who received placebo (n=153), bamlanivimab alone [700 mg (n=100), 2800 mg (n=106), or 7000 mg (n=98)], or bamlanivimab (2800 mg) and etesevimab (2800 mg) together (n=111). A multiplex Luminex serology assay measured antibody titers against SARS-CoV-2 antigens, including SARS-CoV-2 protein variants that evade bamlanivimab or etesevimab binding, and SARS-CoV-2 pseudovirus neutralization assays were performed.
Results


The antibody response in patients who received placebo or mAbs had a broad specificity. Titer change from baseline against a receptor-binding domain mutant (Spike-RBD E484Q), as well as N-terminal domain (Spike-NTD) and nucleocapsid protein (NCP) epitopes were 1.4 to 4.1 fold lower at day 15-85 in mAb recipients compared with placebo. Neutralizing activity of day 29 sera from bamlanivimab monotherapy cohorts against both spike E484Q and beta variant (B.1.351) were slightly reduced compared with placebo (by a factor of 3.1, p=0.001, and 2.9, p=0.002, respectively). Early viral load correlated with the subsequent antibody titers of the native, unmodified humoral response (p<0.0001 at Day 15, 29, 60 and 85 for full-length spike).
Conclusions


Patients with mild or moderate COVID-19 treated with mAbs develop a wide breadth of antigenic responses to SARS-CoV-2. Small reductions in titers and neutralizing activity, potentially due to a decrease in viral load following mAb treatment, suggest minimal impact of mAb treatment on the endogenous immune response.",2021,"Early viral load correlated with the subsequent antibody titers of the native, unmodified humoral response (p<0.0001 at Day 15, 29, 60 and 85 for full-length spike).
","['patients with mild or moderate COVID-19', 'patients with mild or moderate COVID-19 in the BLAZE-1 trial who received', 'Patients']","['placebo', 'Bamlanivimab Alone or Bamlanivimab and Etesevimab Together', 'bamlanivimab (2800 mg) and etesevimab', 'bamlanivimab alone', 'receiving mAbs (bamlanivimab alone and bamlanivimab and etesevimab together']","['antibody response', 'Neutralizing activity', 'hospitalization and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517680', 'cui_str': '2800'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.102715,"Early viral load correlated with the subsequent antibody titers of the native, unmodified humoral response (p<0.0001 at Day 15, 29, 60 and 85 for full-length spike).
","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Poorbaugh', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dougan', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles, CA, United States.""}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Internal Medicine, Center for Advanced Heart and Lung Disease, Baylor University Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Huhn', 'Affiliation': 'The Ruth M. Rothstein CORE Center, Cook County Health, Chicago, IL, United States.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Beasley', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Montanea', 'Initials': 'M', 'LastName': 'Daniels', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Thi', 'Initials': 'T', 'LastName': 'Ngoc Vy Trinh', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Crisp', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Joshua Joaquin', 'Initials': 'JJ', 'LastName': 'Freitas', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vaillancourt', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Dipak R', 'Initials': 'DR', 'LastName': 'Patel', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nirula', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Kallewaard', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Higgs', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Benschop', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States.'}]",Frontiers in immunology,['10.3389/fimmu.2021.790469']
1586,34983126,"Adjuvant daily therapy with L-arginine 2,500 mg and tadalafil 5 mg increases efficacy and duration of benefits of low-intensity extracorporeal shock wave therapy for erectile dysfunction: A prospective, randomized, single-blinded study with 1-year follow-up.","PURPOSE


To investigate a therapeutic protocol for erectile dysfunction (ED) based on the combination of low-intensity extracorporeal shock wave therapy (Li-ESWT), tadalafil, and L-arginine.
MATERIALS AND METHODS


Recruited patients completed the International Index of Erectile Function erectile function domain (IIEF-EF) and the Erection Hardness Score (EHS) questionnaires at baseline and were randomly assigned in two groups: A (treatment group) and B (control group). Men in both groups received six weekly applications of Li-ESWT. Group A was prescribed adjuvant oral therapy with tadalafil 5 mg and L-arginine 2,500 mg. Follow-up visits were scheduled 1, 6, and 12 months after the last Li-ESWT application. At each follow-up visit, the IIEF-EF and EHS questionnaires were administered again. The main outcome measures were the changes from baseline to every follow-up visit in IIEF-EF and EHS scores.
RESULTS


The mean IIEF-EF score in group A was 16.0±4.0, 24.8±3.4, 23.3±4.6, and 21.6±5.5 at baseline, 1, 6, and 12 months of follow-up, respectively, whereas in group B the mean IIEF-EF score was 16.5±4.1, 22.7±4.2, 21.5±4.5, and 19.5±4.9, respectively. We reported an increase in the mean EHS score in group A from 2.07±0.72 at baseline to 3.39±0.59, 3.17±0.67, and 2.98±0.72 at 1, 6, and 12 months, respectively, and in group B from 2.12±0.80 at baseline to 3.07±0.78 and 2.95±0.76 at 1 and 6 months, respectively.
CONCLUSIONS


Adjuvant daily therapy with L-arginine 2,500 mg and tadalafil 5 mg was safe and effective in increasing the efficacy and the duration of benefits of Li-ESWT.",2022,"We reported an increase in the mean EHS score in group A from 2.07±0.72 at baseline to 3.39±0.59, 3.17±0.67, and 2.98±0.72 at 1, 6, and 12 months, respectively, and in group B from 2.12±0.80 at baseline to 3.07±0.78 and 2.95±0.76 at 1 and 6 months, respectively.
","['Recruited patients completed the International Index of Erectile Function erectile function domain (IIEF-EF) and the Erection Hardness Score (EHS) questionnaires at baseline', 'erectile dysfunction']","['low-intensity extracorporeal shock wave therapy', 'tadalafil 5 mg and L-arginine 2,500 mg', 'L-arginine 2,500 mg and tadalafil', 'low-intensity extracorporeal shock wave therapy (Li-ESWT), tadalafil, and L-arginine', 'Li-ESWT']","['mean EHS score', 'mean IIEF-EF score', 'efficacy and duration of benefits', 'changes from baseline to every follow-up visit in IIEF-EF and EHS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2960554', 'cui_str': 'Erection hardness score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C1331168', 'cui_str': 'tadalafil 5 MG'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960554', 'cui_str': 'Erection hardness score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}]",,0.0869265,"We reported an increase in the mean EHS score in group A from 2.07±0.72 at baseline to 3.39±0.59, 3.17±0.67, and 2.98±0.72 at 1, 6, and 12 months, respectively, and in group B from 2.12±0.80 at baseline to 3.07±0.78 and 2.95±0.76 at 1 and 6 months, respectively.
","[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Gallo', 'Affiliation': 'Gallo Uro-Andrology Centre, Naples, Italy. info@studiourologicogallo.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Pecoraro', 'Affiliation': 'Division of Urology, Malzoni Clinic, Avellino, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Sarnacchiaro', 'Affiliation': 'Department of Economics and Management, ""Federico II"" University, Naples, Italy.'}]",Investigative and clinical urology,['10.4111/icu.20210317']
1587,34921084,Vitamin D supplementation in chronic spinal cord injury (VitD-SCI): study protocol for a randomised controlled trial.,"INTRODUCTION


Vitamin D insufficiency, a vitamin D status or serum 25(OH)D concentration of ≤75 nmol/L, is highly prevalent in individuals with a spinal cord injury (SCI). Vitamin D is important for the functioning of the musculoskeletal, immune and respiratory systems, which are relevant determinants of secondary health conditions in SCI. An insufficiency should be treated with vitamin D supplementation. However, there is a lack of evidence regarding the optimal dosage and duration of vitamin D supplementation for individualised and long-term management of the vitamin D status in the context of SCI. This paper presents the protocol for the vitamin D supplementation in chronic spinal cord injury (VitD-SCI) trial that aims to investigate the effect of a 12-month intake of vitamin D supplementation on vitamin D status as well as on several secondary parameters among individuals with a chronic SCI.
METHODS AND ANALYSES


The VitD-SCI trial is a randomised, placebo-controlled, double-blinded, parallel-group, superiority trial, conducted at the Swiss Paraplegic Centre. A total of 45 participants living with an SCI for at least 3 years (chronic SCI) and a vitamin D insufficiency at the first study visit, will be randomly assigned to one of three intervention groups. Participants receive either a monthly dosage of 24 000 IU or 48 000 IU vitamin D or a placebo for 12 months. Measurements taking place every 3 months include the assessment of vitamin D status (primary outcome) as well as bone mineral density, handgrip strength, fatigue, mood, pain and pressure injuries (secondary outcomes). Safety and tolerance of vitamin D supplementation will also be evaluated.
ETHICS AND DISSEMINATION


The Swiss Ethics Committee for Northwest/Central Switzerland (EKNZ, 2020-01493) and the Swiss Agency for Therapeutic Products (Swissmedic, 2020DR3150) approved this study. Findings will be disseminated through peer-reviewed publications.
TRIAL REGISTRATION NUMBERS


NCT04652544 and SNCTP000004032.",2021,"Vitamin D is important for the functioning of the musculoskeletal, immune and respiratory systems, which are relevant determinants of secondary health conditions in SCI.","['individuals with a spinal cord injury (SCI', '45 participants living with an SCI for at least 3\u2009years (chronic SCI) and a vitamin D insufficiency at the first study visit', 'individuals with a chronic SCI', 'chronic spinal cord injury (VitD-SCI']","['placebo', 'vitamin D or a placebo', 'Vitamin D', 'Vitamin D supplementation', 'vitamin D supplementation']","['bone mineral density, handgrip strength, fatigue, mood, pain and pressure injuries (secondary outcomes', 'vitamin D status']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0310589', 'cui_str': 'Vitamin A- and vitamin D-containing product'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0919758', 'cui_str': 'Vitamin D measurement'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",45.0,0.723572,"Vitamin D is important for the functioning of the musculoskeletal, immune and respiratory systems, which are relevant determinants of secondary health conditions in SCI.","[{'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'Hertig-Godeschalk', 'Affiliation': 'Institute of Sports Medicine, Swiss Paraplegic Centre, Nottwil, Switzerland.'}, {'ForeName': 'Martin W G', 'Initials': 'MWG', 'LastName': 'Brinkhof', 'Affiliation': 'Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Scheel-Sailer', 'Affiliation': 'Department of Health Sciences and Medicine, University of Lucerne, Luzerne, Switzerland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Perret', 'Affiliation': 'Institute of Sports Medicine, Swiss Paraplegic Centre, Nottwil, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jenny', 'Affiliation': 'Department of Rehabilitation, Swiss Paraplegic Centre, Nottwil, Switzerland.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Landmann', 'Affiliation': 'Centre for Pain Medicine, Swiss Paraplegic Centre, Nottwil, Switzerland.'}, {'ForeName': 'Patrik O', 'Initials': 'PO', 'LastName': 'Wyss', 'Affiliation': 'Department of Radiology, Swiss Paraplegic Centre, Nottwil, Switzerland.'}, {'ForeName': 'Joelle Leonie', 'Initials': 'JL', 'LastName': 'Flueck', 'Affiliation': 'Institute of Sports Medicine, Swiss Paraplegic Centre, Nottwil, Switzerland joelle.flueck@sportmedizin-nottwil.ch.'}]",BMJ open,['10.1136/bmjopen-2021-053951']
1588,34980494,"Re: Luke Harper, T. Blanc, M. Peycelon, et al. Circumcision and Risk of Febrile Urinary Tract Infection in Boys with Posterior Urethral Valves: Result of the CIRCUP Randomized Trial. Eur Urol. 2022;81:64-72.",,2022,,['Boys with Posterior Urethral Valves'],[],[],"[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0238506', 'cui_str': 'Congenital posterior urethral valves'}]",[],[],,0.0942457,,"[{'ForeName': 'Abhay Singh', 'Initials': 'AS', 'LastName': 'Gaur', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, Bhubaneswar, India. Electronic address: drabhaygaur@live.com.'}, {'ForeName': 'Prasant', 'Initials': 'P', 'LastName': 'Nayak', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, Bhubaneswar, India.'}]",European urology,['10.1016/j.eururo.2021.11.027']
1589,34964849,Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized With COVID-19: A Randomized Clinical Trial.,"Importance


Hospitalized patients with COVID-19 pneumonia have high rates of morbidity and mortality.
Objective


To assess the efficacy of colchicine in hospitalized patients with COVID-19 pneumonia.
Design, Setting, and Participants


The Estudios Clínicos Latino América (ECLA) Population Health Research Institute (PHRI) COLCOVID trial was a multicenter, open-label, randomized clinical trial performed from April 17, 2020, to March 28, 2021, in adults with confirmed or suspected SARS-CoV-2 infection followed for up to 28 days. Participants received colchicine vs usual care if they were hospitalized with COVID-19 symptoms and had severe acute respiratory syndrome or oxygen desaturation. The main exclusion criteria were clear indications or contraindications for colchicine, chronic kidney disease, and negative results on a reverse transcription-polymerase chain reaction test for SARS-CoV-2 before randomization. Data were analyzed from June 20 to July 25, 2021.
Interventions


Patients were assigned in a 1:1 ratio to usual care or usual care plus colchicine. Colchicine was administered orally in a loading dose of 1.5 mg immediately after randomization, followed by 0.5 mg orally within 2 hours of the initial dose and 0.5 mg orally twice a day for 14 days or discharge, whichever occurred first.
Main Outcomes and Measures


The first coprimary outcome was the composite of a new requirement for mechanical ventilation or death evaluated at 28 days. The second coprimary outcome was death at 28 days.
Results


A total of 1279 hospitalized patients (mean [SD] age, 61.8 [14.6] years; 449 [35.1%] women and 830 [64.9%] men) were randomized, including 639 patients in the usual care group and 640 patients in the colchicine group. Corticosteroids were used in 1171 patients (91.5%). The coprimary outcome of mechanical ventilation or 28-day death occurred in 160 patients (25.0%) in the colchicine group and 184 patients (28.8%) in the usual care group (hazard ratio [HR], 0.83; 95% CI, 0.67-1.02; P = .08). The second coprimary outcome, 28-day death, occurred in 131 patients (20.5%) in the colchicine group and 142 patients (22.2%) in the usual care group (HR, 0.88; 95% CI, 0.70-1.12). Diarrhea was the most frequent adverse effect of colchicine, reported in 68 patients (11.3%).
Conclusions and Relevance


This randomized clinical trial found that compared with usual care, colchicine did not significantly reduce mechanical ventilation or 28-day mortality in patients hospitalized with COVID-19 pneumonia.
Trial Registration


ClinicalTrials.gov Identifier: NCT04328480.",2021,"The coprimary outcome of mechanical ventilation or 28-day death occurred in 160 patients (25.0%) in the colchicine group and 184 patients (28.8%) in the usual care group (hazard ratio [HR], 0.83; 95% CI, 0.67-1.02; P = .08).","['Hospitalized patients with COVID-19 pneumonia', 'vs usual care if they were hospitalized with COVID-19 symptoms and had severe acute respiratory syndrome or oxygen desaturation', 'patients hospitalized with COVID-19 pneumonia', 'Patients', 'hospitalized patients with COVID-19 pneumonia', '68 patients (11.3', 'Hospitalized With COVID-19', 'Participants\n\n\nThe Estudios Clínicos Latino América (ECLA) Population Health Research Institute (PHRI) COLCOVID trial was a multicenter, open-label, randomized clinical trial performed from April 17, 2020, to March 28, 2021, in adults with confirmed or suspected SARS-CoV-2 infection followed for up to 28 days', '1279 hospitalized patients (mean [SD] age, 61.8 [14.6] years; 449 [35.1%] women and 830 [64.9%] men) were randomized, including 639 patients in the usual care group and 640 patients in the']","['usual care or usual care plus colchicine', 'Colchicine vs Usual Care', 'Colchicine', 'Corticosteroids', 'colchicine']","['28-day death', 'Intubation and 28-Day Mortality', 'Diarrhea', 'mechanical ventilation or 28-day mortality', 'composite of a new requirement for mechanical ventilation or death', 'death at 28 days', 'mechanical ventilation or 28-day death']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1175175', 'cui_str': 'Severe acute respiratory syndrome'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C3242284', 'cui_str': 'Population Health'}, {'cui': 'C0035172', 'cui_str': 'Research Institutes'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517889', 'cui_str': '830'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4708790', 'cui_str': '640'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205314', 'cui_str': 'New'}]",1279.0,0.150892,"The coprimary outcome of mechanical ventilation or 28-day death occurred in 160 patients (25.0%) in the colchicine group and 184 patients (28.8%) in the usual care group (hazard ratio [HR], 0.83; 95% CI, 0.67-1.02; P = .08).","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Orlandini', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Castellana', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Caccavo', 'Affiliation': 'Hospital de Coronel Suárez Raúl Alfredo Caccavo, Universidad Provincial del Sudoeste, Buenos Aires, Argentina.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Corral', 'Affiliation': 'Departamento de Investigación, Facultad de Medicina, Universidad FASTA, Buenos Aires, Argentina.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Corral', 'Affiliation': 'Infectología Clínica de Mayo, Mar del Plata, Argentina.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Chacón', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lamelas', 'Affiliation': 'Health Research Methods, Evidence, and Impact, Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Botto', 'Affiliation': 'Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'María Luz', 'Initials': 'ML', 'LastName': 'Díaz', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Domínguez', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pascual', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Rovito', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Agustina', 'Initials': 'A', 'LastName': 'Galatte', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Scarafia', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Sued', 'Affiliation': 'Fundación Huésped, Buenos Aires, Argentina.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Gutierrez', 'Affiliation': 'Ministerio de Salud de Jujuy, Jujuy, Argentina.'}, {'ForeName': 'Sanjit S', 'Initials': 'SS', 'LastName': 'Jolly', 'Affiliation': 'Division of Cardiology, Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Canada.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Miró', 'Affiliation': 'Infectious Diseases Service, Hospital Clínic, Instituto de Investigaciones Biomédicas August Pi i Sunyer, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Eikelboom', 'Affiliation': 'Medicine, Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Loeb', 'Affiliation': 'Health Research Methods, Evidence, and Impact, Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Aldo Pietro', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Division of Cardiology, Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2021.41328']
1590,34995935,The effect of l-arginine supplementation and surgical trauma on the frequency of myeloid-derived suppressor cells and T lymphocytes in tumour and blood of colorectal cancer patients.,"PURPOSE


l-arginine (L-arg) deficiency causes immunosuppression, but it is unknown if L-arg supplementation in colorectal cancer (CRC) patients restores immune system activity. Our objective was to investigate the effect of L-arg supplementation on the frequency of monocytic (M) and polymorphonuclear (PNM) myeloid-derived suppressor cells (M-MDSCs and PMN-MDSCs, respectively).
METHODS


We enrolled 65 CRC patients (34 males, 31 females) aged 69 ​± ​10 years into a prospective, randomised, double-blind study. Twenty-eight patients received L-arg and 37 received placebo for 9 days at a dose of 10 ​g/day. The frequency changes in MDSC, CD4 +  cells and the concentration of C-reactive protein (CRP) were assessed before supplementation with L-arg (test 1), after 9 days of supplementation (test 2), and after surgery on day 11 (test 3).
RESULTS


The frequency of M-MDSC in the tumours of patients receiving L-arg supplementation was higher than in placebo-treated patients, as was the frequency of PMN-MDSC and M-MDSC in the mucosa. CRP concentration in the serum of placebo-treated patients in test 2 was higher than in test 1, and the concentration in the serum of patients with L-arg supplementation in test 2 was lower than in test 1. Moreover, the expression pattern of the argininosuccinate synthase 1 (ASS1) suggests that CRC is not auxotrophic for L-arg.
CONCLUSIONS


The results of this study do not support the hypothesis that L-arg supplementation in CRC patients can reduce immunosuppression by decreasing the frequency of suppressor cells and increasing the frequency of effector CD4 +  T cells.",2022,"The frequency of M-MDSC in the tumours of patients receiving L-arg supplementation was higher than in placebo-treated patients, as was the frequency of PMN-MDSC and M-MDSC in the mucosa.","['colorectal cancer (CRC) patients', 'colorectal cancer patients', '65 CRC patients (34 males, 31 females) aged 69\xa0\u200b±\xa0\u200b10 years']","['placebo', 'l-arginine supplementation', 'L-arg supplementation']","['frequency changes in MDSC, CD4 +  cells and the concentration of C-reactive protein (CRP', 'frequency of monocytic (M) and polymorphonuclear (PNM) myeloid-derived suppressor cells (M-MDSCs and PMN-MDSCs, respectively', 'CRP concentration', 'frequency of M-MDSC', 'frequency of PMN-MDSC and M-MDSC']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4277543', 'cui_str': 'MDSCs'}, {'cui': 'C3251824', 'cui_str': 'Cell positive for CD4 antigen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}]",65.0,0.256518,"The frequency of M-MDSC in the tumours of patients receiving L-arg supplementation was higher than in placebo-treated patients, as was the frequency of PMN-MDSC and M-MDSC in the mucosa.","[{'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Szefel', 'Affiliation': 'Division of Oncological Propedeutics, Faculty of Health Sciences, Medical University of Gdansk, Gdynia, Poland. Electronic address: jaszefel@gumed.edu.pl.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Ślebioda', 'Affiliation': 'Department of Histology, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Walczak', 'Affiliation': 'Department of Surgical Oncology, Gdynia Oncology Centre, Maritime Polish Red Cross Memorial Hospital, Gdynia, Poland.'}, {'ForeName': 'Wiesław Janusz', 'Initials': 'WJ', 'LastName': 'Kruszewski', 'Affiliation': 'Division of Oncological Propedeutics, Faculty of Health Sciences, Medical University of Gdansk, Gdynia, Poland; Department of Surgical Oncology, Gdynia Oncology Centre, Maritime Polish Red Cross Memorial Hospital, Gdynia, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Szajewski', 'Affiliation': 'Division of Oncological Propedeutics, Faculty of Health Sciences, Medical University of Gdansk, Gdynia, Poland; Department of Surgical Oncology, Gdynia Oncology Centre, Maritime Polish Red Cross Memorial Hospital, Gdynia, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Ciesielski', 'Affiliation': 'Division of Oncological Propedeutics, Faculty of Health Sciences, Medical University of Gdansk, Gdynia, Poland; Department of Surgical Oncology, Gdynia Oncology Centre, Maritime Polish Red Cross Memorial Hospital, Gdynia, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Stanisławowski', 'Affiliation': 'Department of Histology, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Buczek', 'Affiliation': 'Division of Oncological Propedeutics, Faculty of Health Sciences, Medical University of Gdansk, Gdynia, Poland; Department of Surgical Oncology, Gdynia Oncology Centre, Maritime Polish Red Cross Memorial Hospital, Gdynia, Poland.'}, {'ForeName': 'Sylwia', 'Initials': 'S', 'LastName': 'Małgorzewicz', 'Affiliation': 'Department of Clinical Nutrition, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Owczarzak', 'Affiliation': 'Department of Clinical Nutrition, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Aleksandrowicz-Wrona', 'Affiliation': 'Department of Clinical Nutrition, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Krzykowski', 'Affiliation': 'Faculty of Finance and Management, WSB University in Gdansk, Gdansk, Poland.'}]",Advances in medical sciences,['10.1016/j.advms.2021.12.005']
1591,34962008,Effect of early skin-to-skin contact after vaginal delivery on pain during perineal wound suturing: A randomized controlled trial.,"AIM


To evaluate whether early skin-to-skin contact at the end of the second stage of labor could relieve perineal wound suture pain.
METHODS


From March 2020 to November 2020, a total of 241 parturients with full-term single fetuses delivered through the vagina and who underwent episiotomy suture (n = 120) or perineal laceration repair (n = 121) in our hospital were included in the study. Parturients were categorized according to whether they received episiotomy suture or perineal laceration repair. They were randomized into an early skin contact group and a traditional neonatal care group. The primary outcome was pain, which was quantified by the Numerical Rating Scale, Visual Analog Scale, Verbal Rating Scale, Faces Pain Scale-Revised. The secondary outcomes were healing of the perineal wound, the maternal cooperation rate and operation time. The confounding factors of severe pain were analyzed.
RESULTS


Early skin-to-skin contact alleviated the pain of perineal laceration repair and episiotomy suture, shortened the operation time of episiotomy suture and improved the cooperation rate of parturients receiving suture. It had no effect on perineal wound healing, operation time, or the cooperation rate of perineal laceration repair. In addition to the operation and early skin contact, the occurrence of high-grade pain was also associated with prepregnancy body mass index, group B streptococcus (GBS) positive, and academic degree.
CONCLUSION


Early skin-to-skin contact at the end of the second stage of labor can alleviate pain and improve the delivery experience of vaginal delivery.",2022,"It had no effect on perineal wound healing, operation time, or the cooperation rate of perineal laceration repair.","['From March 2020 to November 2020, a total of 241 parturients with full-term single fetuses delivered through the vagina and who underwent', 'n\xa0=\xa0121) in our hospital were included in the study', 'pain during perineal wound suturing']","['early skin contact group and a traditional neonatal care group', 'episiotomy suture or perineal laceration repair', 'early skin-to-skin contact', 'episiotomy suture (n\xa0=\xa0120) or perineal laceration repair']","['occurrence of high-grade pain', 'operation time of episiotomy suture', 'healing of the perineal wound, the maternal cooperation rate and operation time', 'pain of perineal laceration repair and episiotomy suture', 'pain, which was quantified by the Numerical Rating Scale, Visual Analog Scale, Verbal Rating Scale, Faces Pain Scale-Revised', 'perineal wound healing, operation time, or the cooperation rate of perineal laceration repair', 'cooperation rate']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",241.0,0.0295473,"It had no effect on perineal wound healing, operation time, or the cooperation rate of perineal laceration repair.","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Department of Obstetrics, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Maternal and Child Health Care Hospital, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Maternal and Child Health Care Hospital, Beijing, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Obstetrics, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Maternal and Child Health Care Hospital, Beijing, China.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Obstetrics, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Maternal and Child Health Care Hospital, Beijing, China.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.15120']
1592,34963636,HIV-associated talaromycosis: Does timing of antiretroviral therapy matter?,"OBJECTIVES


No current academic data is available with respect to the optimal timing to initiate antiretroviral therapy (ART) in HIV-positive patients with talaromycosis. Our study aimed to evaluate the optimal timing of ART initiation for patients presenting with AIDS-related talaromycosis.
METHODS


In this prospective, randomized, open-label multicenter trial, 228 patients from 15 hospitals in China were randomly assigned to an early ART group (initiation of ART within 2 weeks after randomization) and a deferred ART group (initiation of ART 2 weeks after randomization). The primary endpoint was all-cause mortality during the 48 weeks after randomization.
RESULTS


We observed a significant difference in mortality between the early ART group and the deferred ART group (2.2% vs. 8.9%, 95%CI: -0.15 to 14.05, p = 0.049). The composite outcome of AIDS-defining events or death in the early ART group was found to be lower than that in the deferred ART group (3.3% vs. 14.9%; 95%CI: 2.93 to 19.23, p = 0.008).
CONCLUSIONS


The prognosis of HIV-infected patients with talaromycosis in the early ART group was more favorable than that of patients in the deferred ART group. These results demonstrate that early ART initiation should be considered in HIV-infected patients with talaromycosis .",2022,"The composite outcome of AIDS-defining events or death in the early ART group was found to be lower than that in the deferred ART group (3.3% vs. 14.9%; 95%CI: 2.93 to 19.23, p = ","['228 patients from 15 hospitals in China', 'HIV-positive patients with talaromycosis', 'patients presenting with AIDS-related talaromycosis']","['early ART group (initiation of ART', 'HIV-associated talaromycosis']","['mortality', 'AIDS-defining events or death', 'cause mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",228.0,0.0888068,"The composite outcome of AIDS-defining events or death in the early ART group was found to be lower than that in the deferred ART group (3.3% vs. 14.9%; 95%CI: 2.93 to 19.23, p = ","[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Songtao', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Yanqiu', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Jingmin', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ouyang', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yingmei', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': ""Department of Infectious Diseases, the Fourth People's Hospital of Nanning, Guangxi, China.""}, {'ForeName': 'Zhongsheng', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Infectious Diseases, Liuzhou General Hospital, Guangxi, China.'}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, the First Hospital of Changsha, Hunan, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': ""Department of Infectious Diseases, the Third People's Hospital of Guilin, Guangxi, China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Lan', 'Affiliation': 'Department of Infectious Disease, Longtan Hospital of Guangxi Zhuang Autonomous Region, Guangxi, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Infectious Diseases, the Third People's Hospital of Shenzhen, Guangdong, China.""}, {'ForeName': 'Xinping', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Infectious Diseases, Yunnan Provincial Infectious Disease Hospital, Yunnan, China.'}, {'ForeName': 'Kaiyin', 'Initials': 'K', 'LastName': 'He', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangdong, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Infectious Diseases, Kunming Third People's Hospital, Yunnan, China.""}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Harypursat', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Yaokai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China. Electronic address: yaokaichen@hotmail.com.'}]",The Journal of infection,['10.1016/j.jinf.2021.12.032']
1593,34916327,"Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial).","INTRODUCTION


Postoperative pain remains incompletely controlled for decades. Recently, multimodal analgesia is emerging as a potential approach in the management of postoperative pain. Therein, S(+)-ketamine is appealing as an adjuvant drug in multimodal analgesia due to its unique pharmacological advantages. This pragmatic clinical trial (SAFE-SK-A trial) is designed to investigate the analgesic effect and safety of S(+)-ketamine for acute postoperative pain in adults and explore the optimal strategy of perioperative intravenous S(+)-ketamine in a real-world setting.
METHODS AND ANALYSIS


This multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A study) is planned to conduct in 80 centres from China and recruit a total of 12 000 adult participants undergoing a surgical procedure under general anaesthesia. Patient recruitment started in June 2021 and will end in June 2022. Participants will be randomised in a ratio of 2:1 to either receive perioperative intravenous S(+)-ketamine plus conventional anaesthesia or conventional anaesthesia only. Given the pragmatic nature of the study, no specific restriction as to the administration dosage, route, time, synergistic regimen or basic analgesics. Primary endpoints are the area under the broken line of Numerical Rating Scale (NRS) scores for pain intensity and the total opioid consumption within 48 hours postoperative. Secondary endpoints are postoperative NRS scores, the anaesthesia recovery time, time of first rescue analgesia, the incidence of rescue analgesia, the incidence of postoperative delirium, patient questionnaire for effect, changes from baseline in cognitive function and anxiety and depression, as well as the adverse events and pharmacoeconomic outcomes. The general linear model will be used for the primary endpoint, and appropriate methods will be used for the secondary endpoints.
ETHICS AND DISSEMINATION


This trial has been approved by the local Institutional Review Board (S2021-026-02) and conducted following the Declaration of Helsinki. Results of this trial will be publicly disclosed and published in scientific journals.
TRIAL REGISTRATION NUMBER


NCT04837170; Pre-results.",2021,"Secondary endpoints are postoperative NRS scores, the anaesthesia recovery time, time of first rescue analgesia, the incidence of rescue analgesia, the incidence of postoperative delirium, patient questionnaire for effect, changes from baseline in cognitive function and anxiety and depression, as well as the adverse events and pharmacoeconomic outcomes.","['acute postoperative pain in adults', '80 centres from China and recruit a total of 12\u2009000 adult participants undergoing a surgical procedure under general anaesthesia']","['perioperative intravenous S(+)-ketamine plus conventional anaesthesia or conventional anaesthesia only', 'Perioperative intravenous S(+)-ketamine', 'S(+)-ketamine']","['area under the broken line of Numerical Rating Scale (NRS) scores for pain intensity and the total opioid consumption', 'postoperative NRS scores, the anaesthesia recovery time, time of first rescue analgesia, the incidence of rescue analgesia, the incidence of postoperative delirium, patient questionnaire for effect, changes from baseline in cognitive function and anxiety and depression, as well as the adverse events and pharmacoeconomic outcomes']","[{'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0206335', 'cui_str': 'Pharmaceutical Economics'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",12000.0,0.472753,"Secondary endpoints are postoperative NRS scores, the anaesthesia recovery time, time of first rescue analgesia, the incidence of rescue analgesia, the incidence of postoperative delirium, patient questionnaire for effect, changes from baseline in cognitive function and anxiety and depression, as well as the adverse events and pharmacoeconomic outcomes.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Chong-Yang', 'Initials': 'CY', 'LastName': 'Duan', 'Affiliation': 'Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Wen-Qi', 'Initials': 'WQ', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, China.'}, {'ForeName': 'Li-Zhi', 'Initials': 'LZ', 'LastName': 'Zhou', 'Affiliation': 'Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yan-Hong', 'Initials': 'YH', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The First Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Cun-Ming', 'Initials': 'CM', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Jiangsu Province Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hai-Chen', 'Initials': 'HC', 'LastName': 'Chu', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yu-Gang', 'Initials': 'YG', 'LastName': 'Diao', 'Affiliation': 'Department of Anesthesiology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Hua', 'Affiliation': 'Department of Anesthesiology, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Qing-Tao', 'Initials': 'QT', 'LastName': 'Meng', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The First Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Mi', 'Affiliation': 'Department of Anesthesiology, The First Medical Center of Chinese PLA General Hospital, Beijing, China wwdd1962@aliyun.com chenpy99@126.com.'}, {'ForeName': 'Ping-Yan', 'Initials': 'PY', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, Guangdong, China wwdd1962@aliyun.com chenpy99@126.com.'}]",BMJ open,['10.1136/bmjopen-2021-054681']
1594,34986487,"Effects of Computer-Based Cognitive Rehabilitation on Attention, Executive Functions, and Quality of Life in Patients with Parkinson's Disease: A Randomized, Controlled, Single-Blinded Pilot Study.","BACKGROUND


Cognitive decline in Parkinson's disease (PD) has become increasingly recognized in recent years, and there is a need to identify methods for cognitive rehabilitation in PD patients.
OBJECTIVE


The aim of this study was to explore the feasibility and effects of 2 different computer-based cognitive rehabilitation (CBCR) interventions on attention, executive functions, and quality of life (QoL) in PD patients.
METHODS


Thirty nondemented PD patients were randomly assigned to one of 3 groups: one passive control group and 2 intervention groups with 2 different CBCR programmes. The intervention period was 8 weeks with follow-up visits in clinic every second week. Before and after the intervention period, patients were tested with a neuropsychological battery of attention, executive functions, and QoL.
RESULTS


Twenty-four patients completed the study. Patients in one of the CBCR groups experienced a significant within-group increase on the primary measures of attention, executive functions, and QoL. However, this effect was not significant between groups. No significant differences were observed for the other CBCR group or the control group.
CONCLUSIONS


CBCR is a feasible intervention for cognitive rehabilitation in nondemented PD patients. The effects of training were modest and should be further explored in larger clinical trials. Some CBCR programmes might be more effective than others for PD patients. The protocol for this study was published prospectively at ClinicalTrials.gov on September 18, 2017 with ID: NCT03285347.",2021,"Patients in one of the CBCR groups experienced a significant within-group increase on the primary measures of attention, executive functions, and QoL.","['PD patients', ""Parkinson's disease (PD"", 'Thirty nondemented PD patients', ""Patients with Parkinson's Disease"", 'nondemented PD patients']","['Computer-Based Cognitive Rehabilitation', '2 different computer-based cognitive rehabilitation (CBCR) interventions', 'CBCR', 'passive control group and 2 intervention groups with 2 different CBCR programmes']","['attention, executive functions, and QoL', 'Attention, Executive Functions, and Quality of Life', 'attention, executive functions, and quality of life (QoL']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0258952,"Patients in one of the CBCR groups experienced a significant within-group increase on the primary measures of attention, executive functions, and QoL.","[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Svaerke', 'Affiliation': 'Department of Neurology, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Andreas Kirknaes', 'Initials': 'AK', 'LastName': 'Faerk', 'Affiliation': 'Unit for Cognitive Neuroscience, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Asta', 'Initials': 'A', 'LastName': 'Riis', 'Affiliation': 'Unit for Cognitive Neuroscience, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Susanne Ebba Maja', 'Initials': 'SEM', 'LastName': 'Stiegnitz von Ehrenfels', 'Affiliation': 'Department of Neurology, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Mogensen', 'Affiliation': 'Unit for Cognitive Neuroscience, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Annemette', 'Initials': 'A', 'LastName': 'Lokkegaard', 'Affiliation': 'Department of Neurology, Bispebjerg Hospital, Copenhagen, Denmark.'}]",Dementia and geriatric cognitive disorders,['10.1159/000520591']
1595,34987204,"A behavioral weight-loss intervention, but not metformin, decreases a marker of gut barrier permeability: results from the SPIRIT randomized trial.","BACKGROUND/OBJECTIVES


Lipopolysaccharide-binding protein (LBP), a biomarker of gut barrier permeability to lipopolysaccharides, is higher in adults with obesity and type 2 diabetes. Behavioral weight loss and metformin have distinct effects on the gut microbiome, but their impact on gut permeability to lipopolysaccharides is unknown. This study's objective was to determine the effects of a behavioral weight-loss intervention or metformin treatment on plasma LBP.
SUBJECTS/METHODS


SPIRIT was a randomized trial of adults with overweight or obesity. Participants were randomized to one of three arms: metformin treatment, coach-directed behavioral weight loss on a DASH diet, or self-directed care (control). Of 121 participants, a random subset (n = 88) was selected to have LBP measured at baseline, 6 months, and 12 months post intervention. Intervention effects on LBP over time were assessed using generalized estimating equations (GEE). We also examined whether the intervention effects were modified by change in diet and weight.
RESULTS


Arms were balanced by sex (83% female), race (51% white), and age (mean 60 years), with no differences in baseline LBP (median 4.23 μg/mL). At 1 year, mean weight change was -3.00% in the metformin arm, -3.02% in the coach-directed behavioral weight-loss arm, and +0.33% in the self-directed (control) arm. The corresponding change in LBP was +1.03, -0.98, +1.03 μg/mL. The behavioral weight-loss intervention reduced LBP compared to self-directed care (β = -0.17, 95% CI: -0.33 to -0.01); no other between-arm comparisons were significant. Behavioral weight-loss participants who reduced dietary fat showed the greatest reductions in 6-month LBP (β = -2.84, 95% CI: -5.17 to -0.50).
CONCLUSIONS


Despite similar weight loss in the behavioral weight loss arm and the metformin arm, only the behavioral weight-loss intervention reduced LBP compared to control. Lifestyle weight-loss interventions that promote a DASH diet may be effective at reducing gut barrier permeability to lipopolysaccharides.
CLINICAL TRIALS REGISTRATION NUMBER


NCT02431676, https://clinicaltrials.gov.",2022,"The behavioral weight-loss intervention reduced LBP compared to self-directed care (β = -0.17, 95% CI: -0.33 to -0.01); no other between-arm comparisons were significant.","['adults with obesity and type 2 diabetes', 'adults with overweight or obesity', 'Of 121 participants, a random subset (n\u2009=\u200988']","['behavioral weight-loss intervention or metformin', 'Lipopolysaccharide-binding protein (LBP', 'metformin', 'LBP', 'metformin treatment, coach-directed behavioral weight loss on a DASH diet, or self-directed care (control']","['plasma LBP', 'mean weight change', 'gut barrier permeability', 'LBP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0065054', 'cui_str': 'lipopolysaccharide-binding protein'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0065054', 'cui_str': 'lipopolysaccharide-binding protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]",121.0,0.0734783,"The behavioral weight-loss intervention reduced LBP compared to self-directed care (β = -0.17, 95% CI: -0.33 to -0.01); no other between-arm comparisons were significant.","[{'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Tilves', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Nisa', 'Initials': 'N', 'LastName': 'Maruthur', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Mueller', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA. nmuelle4@jhu.edu.'}]",International journal of obesity (2005),['10.1038/s41366-021-01039-2']
1596,34989404,The longitudinal impact of an evidence-based multiple family group intervention (Amaka Amasanyufu) on oppositional defiant disorder and impaired functioning among children in Uganda: analysis of a cluster randomized trial from the SMART Africa-Uganda scale-up study (2016-2022).,"BACKGROUND


Oppositional Defiant Disorders (ODDs) and other Disruptive Behavior Disorders (DBDs) are common among children and adolescents in poverty-impacted communities in sub-Saharan Africa. Without early intervention, its progression into adulthood can result in dire consequences. We examined the impact of a manualized family strengthening intervention called Amaka Amasanyufu designed to reduce ODDs and other DBDs among school-going children residing in low-resource communities in Uganda.
METHODS


We used longitudinal data from the SMART Africa-Uganda study (2016-2022). Public primary schools were randomized to: (1) Control condition (receiving usual care comprising generalized psychosocial functioning literature), 10 schools; (2) intervention delivered via parent peers (Amaka-parents), 8 schools or; (3) intervention delivered via community healthcare workers (Amaka-community), 8 schools. All the participants were blinded. At baseline, 8- and 16-weeks postintervention initiation, caregivers completed the Iowa Conners Scale, which measured Oppositional Defiant Disorder (ODD) and Impairment Rating Scale to evaluate children's overall impairment and impaired functioning with peers, siblings, and parents; impaired academic progress, self-esteem, and family functioning. Three-level linear mixed-effects models were fitted to each outcome. Pairwise comparisons of postbaseline group means within each time point were performed using Sidak's adjustment for multiple comparisons. Only children positive for ODD and other DBDs were analyzed.
RESULTS


Six hundred and thirty-six children screened positive for ODDs and other DBDs (Controls: n = 243; Amaka-parents: n = 194; Amaka-community: n = 199). At 8 weeks, Amaka-parents' children had significantly lower mean scores for overall impairment compared to controls, (mean difference: -0.71, p = .001), while Amaka-community children performed better on ODD (mean difference: -0.84, p = .016). At 16 weeks, children in both groups were performing better on ODD and IRS than controls, and there were no significant differences between the two intervention groups.
CONCLUSIONS


The Amaka Amasanyufu intervention was efficacious in reducing ODD and impaired functioning relative to usual care. Hence, the Amaka Amasanyufu intervention delivered either by Amaka-community or Amaka-parents has the potential to reduce negative behavioral health outcomes among young people in resource-limited settings and improve family functioning.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03081195. Registered on 16 March 2017.",2022,"At 16 weeks, children in both groups were performing better on ODD and IRS than controls, and there were no significant differences between the two intervention groups.
","['school-going children residing in low-resource communities in Uganda', 'Public primary schools', 'oppositional defiant disorder and impaired functioning among children in Uganda', 'Oppositional Defiant Disorders (ODDs) and other Disruptive Behavior Disorders (DBDs', 'children and adolescents in poverty-impacted communities in sub-Saharan Africa', 'Six hundred and thirty-six children screened positive for ODDs and other DBDs (Controls: n\u2009=\u2009243; Amaka-parents: n\u2009=\u2009194; Amaka-community: n\u2009=\u2009199']","['evidence-based multiple family group intervention (Amaka Amasanyufu', 'Amaka Amasanyufu intervention', 'Control condition (receiving usual care comprising generalized psychosocial functioning literature), 10 schools; (2) intervention delivered via parent peers (Amaka-parents), 8 schools or; (3) intervention delivered via community healthcare workers (Amaka-community), 8 schools', 'manualized family strengthening intervention called Amaka Amasanyufu']","[""Iowa Conners Scale, which measured Oppositional Defiant Disorder (ODD) and Impairment Rating Scale to evaluate children's overall impairment and impaired functioning with peers, siblings, and parents; impaired academic progress, self-esteem, and family functioning""]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012734', 'cui_str': 'Disruptive behavior disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0086034', 'cui_str': 'Community Healthcare'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1299701', 'cui_str': 'Academic progress'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}]",,0.160124,"At 16 weeks, children in both groups were performing better on ODD and IRS than controls, and there were no significant differences between the two intervention groups.
","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Brathwaite', 'Affiliation': 'Brown School, International Center for Child Health and Development, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Brown School, International Center for Child Health and Development, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'Brown School, International Center for Child Health and Development, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McKay', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Division of Prevention Science, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Phionah', 'Initials': 'P', 'LastName': 'Namatovu', 'Affiliation': 'Brown School, International Center for Child Health and Development, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kiyingi', 'Affiliation': 'Brown School, International Center for Child Health and Development, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Zmachinski', 'Affiliation': 'Brown School, International Center for Child Health and Development, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Nabayinda', 'Affiliation': 'Brown School, International Center for Child Health and Development, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Keng-Yen', 'Initials': 'KY', 'LastName': 'Huang', 'Affiliation': 'Department of Child and Adolescent Psychiatry, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Apollo', 'Initials': 'A', 'LastName': 'Kivumbi', 'Affiliation': 'Reach the Youth-Uganda, Kampala, Uganda.'}, {'ForeName': 'Arvin', 'Initials': 'A', 'LastName': 'Bhana', 'Affiliation': 'South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Mwebembezi', 'Affiliation': 'Reach the Youth-Uganda, Kampala, Uganda.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Hoagwood', 'Affiliation': 'Department of Child and Adolescent Psychiatry at the School of Medicine, New York University, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'International Center for Child Health and Development, Masaka, Uganda.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13566']
1597,34930745,Study protocol for a randomised controlled trial on the effect of local analgesia for pain relief after minimal invasive sacroiliac joint fusion: the ARTEMIS study.,"INTRODUCTION


Chronic lower back pain is a common report in the general population. A dysfunctional sacroiliac joint (SIJ) is estimated to be responsible for one in five patients with lower back pain. Minimally invasive sacroiliac joint fusion (MISJF) is a surgical procedure to treat SIJ dysfunction. During the procedure, the SIJ is stabilised by implants inserted percutaneously under fluoroscopy guidance. Postoperatively, patients often report a lot of pain, which contributes to patients taking high doses of painkillers (opioids for example,) and preventing early mobilisation. In several orthopaedic procedures, intraoperative infiltration of the wound bed results in decreased consumption of analgesics, earlier mobilisation and shorter hospitalisation time. The aim of this study is to investigate the effectiveness of intraoperative SIJ infiltration with analgesia in reducing postoperative pain after MISJF.
METHODS AND ANALYSIS


We will perform a two-centre, prospective, double-blind, randomised controlled trial to determine whether SIJ infiltration with 1.5-5 cc bupivacaine 0.50% is superior to 1.5-5 cc placebo (NaCl 0.9%) in reducing postoperative pain in patients after MISJF, and to determine whether bupivacaine significantly reduces opioid use in the direct postoperative period. Patients will be randomised with 1:1 allocation for either bupivacaine (intervention) or placebo SIJ infiltration. Postoperative pain will be measured by the Visual Analogue Scale pain score at entry and exit recovery, 2, 4, 6, 24 and 48 hours postoperatively.
ETHICS AND DISSEMINATION


This is the first trial that investigates the effectiveness of intraoperative SIJ infiltration with bupivacaine 0.50% in reducing postoperative pain after MISJF. If intraoperative SIJ infiltration with bupivacaine 0.50% proves to be effective, this might have important clinical implications, such as postoperative analgesics (opioids for example,) consumption, earlier mobilisation and potentially shorter hospitalisation time.
TRIAL REGISTRATION NUMBER


NL9151.",2021,"In several orthopaedic procedures, intraoperative infiltration of the wound bed results in decreased consumption of analgesics, earlier mobilisation and shorter hospitalisation time.","['pain relief after minimal invasive sacroiliac joint fusion', 'five patients with lower back pain']","['placebo', 'Minimally invasive sacroiliac joint fusion (MISJF', 'bupivacaine (intervention) or placebo SIJ infiltration', 'bupivacaine', 'intraoperative SIJ infiltration with analgesia', 'local analgesia']","['Postoperative pain', 'Visual Analogue Scale pain score', 'postoperative pain', 'Chronic lower back pain', 'consumption of analgesics, earlier mobilisation and shorter hospitalisation time']","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0036036', 'cui_str': 'Sacroiliac joint structure'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0036036', 'cui_str': 'Sacroiliac joint structure'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205276', 'cui_str': 'Local'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.259086,"In several orthopaedic procedures, intraoperative infiltration of the wound bed results in decreased consumption of analgesics, earlier mobilisation and shorter hospitalisation time.","[{'ForeName': 'Sem M M', 'Initials': 'SMM', 'LastName': 'Hermans', 'Affiliation': 'Orthopaedic Surgery, Zuyderland Medical Centre Heerlen, Heerlen, Limburg, Netherlands semhermans@hotmail.com.'}, {'ForeName': 'Jorm M', 'Initials': 'JM', 'LastName': 'Nellensteijn', 'Affiliation': 'Orthopaedic Surgery, Medical Spectrum Twente, Enschede, Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'van Santbrink', 'Affiliation': 'Neurosurgery, Zuyderland Medical Centre Heerlen, Heerlen, Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Knoef', 'Affiliation': 'Orthopaedic Surgery, Medical Spectrum Twente, Enschede, Netherlands.'}, {'ForeName': 'Mattheus K', 'Initials': 'MK', 'LastName': 'Reinders', 'Affiliation': 'Clinical Pharmacy, Pharmacology and Toxicology, Zuyderland Medical Centre Heerlen, Heerlen, Limburg, Netherlands.'}, {'ForeName': 'Daisy M N', 'Initials': 'DMN', 'LastName': 'Hoofwijk', 'Affiliation': 'Anaesthesiology, Zuyderland Medical Centre Heerlen, Heerlen, Limburg, Netherlands.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Potters', 'Affiliation': 'Anaesthesiology, Medical Spectrum Twente, Enschede, Netherlands.'}, {'ForeName': 'Kris L L', 'Initials': 'KLL', 'LastName': 'Movig', 'Affiliation': 'Department of Clinical Pharmacy, Medical Spectrum Twente, Enschede, Netherlands.'}, {'ForeName': 'Inez', 'Initials': 'I', 'LastName': 'Curfs', 'Affiliation': 'Orthopaedic Surgery, Zuyderland Medical Centre Heerlen, Heerlen, Limburg, Netherlands.'}, {'ForeName': 'Wouter L W', 'Initials': 'WLW', 'LastName': 'van Hemert', 'Affiliation': 'Orthopaedic Surgery, Zuyderland Medical Centre Heerlen, Heerlen, Limburg, Netherlands.'}]",BMJ open,['10.1136/bmjopen-2021-056204']
1598,34980495,"A Phase 2 Trial of the Effect of Antiandrogen Therapy on COVID-19 Outcome: No Evidence of Benefit, Supported by Epidemiology and In Vitro Data.","BACKGROUND


Men are more severely affected by COVID-19. Testosterone may influence SARS-CoV-2 infection and the immune response.
OBJECTIVE


To clinically, epidemiologically, and experimentally evaluate the effect of antiandrogens on SARS-CoV-2 infection.
DESIGNS, SETTINGS, AND PARTICIPANTS


A randomized phase 2 clinical trial (COVIDENZA) enrolled 42 hospitalized COVID-19 patients before safety evaluation. We also conducted a population-based retrospective study of 7894 SARS-CoV-2-positive prostate cancer patients and an experimental study using an air-liquid interface three-dimensional culture model of primary lung cells.
INTERVENTION


In COVIDENZA, patients were randomized 2:1 to 5 d of enzalutamide or standard of care.
OUTCOME MEASUREMENTS


The primary outcomes in COVIDENZA were the time to mechanical ventilation or discharge from hospital. The population-based study investigated risk of hospitalization, intensive care, and death from COVID-19 after androgen inhibition.
RESULTS AND LIMITATIONS


Enzalutamide-treated patients required longer hospitalization (hazard ratio [HR] for discharge from hospital 0.43, 95% confidence interval [CI] 0.20-0.93) and the trial was terminated early. In the epidemiological study, no preventive effects were observed. The frail population of patients treated with androgen deprivation therapy (ADT) in combination with abiraterone acetate or enzalutamide had a higher risk of dying from COVID-19 (HR 2.51, 95% CI 1.52-4.16). In vitro data showed no effect of enzalutamide on virus replication. The epidemiological study has limitations that include residual confounders.
CONCLUSIONS


The results do not support a therapeutic effect of enzalutamide or preventive effects of bicalutamide or ADT in COVID-19. Thus, these antiandrogens should not be used for hospitalized COVID-19 patients or as prevention for COVID-19. Further research on these therapeutics in this setting are not warranted.
PATIENT SUMMARY


We studied whether inhibition of testosterone could diminish COVID-19 symptoms. We found no evidence of an effect in a clinical study or in epidemiological or experimental investigations. We conclude that androgen inhibition should not be used for prevention or treatment of COVID-19.",2022,The results do not support a therapeutic effect of enzalutamide or preventive effects of bicalutamide or ADT in COVID-19.,"['42 hospitalized COVID-19 patients before safety evaluation', '7894 SARS-CoV-2-positive prostate cancer patients and an experimental study using an air-liquid interface three-dimensional culture model of primary lung cells']","['bicalutamide', 'testosterone', 'Testosterone', 'abiraterone acetate or enzalutamide', 'enzalutamide or standard of care', 'enzalutamide', 'androgen deprivation therapy (ADT', 'Antiandrogen Therapy']","['longer hospitalization (hazard ratio [HR', 'time to mechanical ventilation or discharge from hospital', 'COVID-19 Outcome']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0285590', 'cui_str': 'bicalutamide'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0002842', 'cui_str': 'Antiandrogen'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",42.0,0.133888,The results do not support a therapeutic effect of enzalutamide or preventive effects of bicalutamide or ADT in COVID-19.,"[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Welén', 'Affiliation': 'Institute of Clinical Sciences, Department of Urology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Ebba', 'Initials': 'E', 'LastName': 'Rosendal', 'Affiliation': 'Department of Clinical Microbiology, Section of Virology, Umeå University, Umeå, Sweden; The Laboratory for Molecular Infection Medicine Sweden, Umeå, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Gisslén', 'Affiliation': 'Institute of Biomedicine, Department of Infectious Diseases, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Infectious Diseases, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Annasara', 'Initials': 'A', 'LastName': 'Lenman', 'Affiliation': 'Department of Clinical Microbiology, Section of Virology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Freyhult', 'Affiliation': 'Department of Medical Sciences, National Bioinformatics Infrastructure Sweden, Science for Life Laboratory, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Osvaldo', 'Initials': 'O', 'LastName': 'Fonseca-Rodríguez', 'Affiliation': 'Department of Clinical Microbiology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bremell', 'Affiliation': 'Institute of Biomedicine, Department of Infectious Diseases, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Stranne', 'Affiliation': 'Institute of Clinical Sciences, Department of Urology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Åse Östholm', 'Initials': 'ÅÖ', 'LastName': 'Balkhed', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Niward', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Repo', 'Affiliation': 'Department of Clinical Microbiology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Robinsson', 'Affiliation': 'Department of Urology, Region of Jönköping, Jönköping, Sweden.'}, {'ForeName': 'Anna J', 'Initials': 'AJ', 'LastName': 'Henningsson', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden; Department of Clinical Microbiology, Region Jönköping County, Jönköping, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Styrke', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Urology & Andrology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Angelin', 'Affiliation': 'Department of Clinical Microbiology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lindquist', 'Affiliation': 'Department of Clinical Microbiology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Allard', 'Affiliation': 'Department of Clinical Microbiology, Section of Virology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Becker', 'Affiliation': 'Department of Clinical Microbiology, Section of Virology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Stina', 'Initials': 'S', 'LastName': 'Rudolfsson', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Urology & Andrology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Buckland', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Urology & Andrology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Camilla Thellenberg', 'Initials': 'CT', 'LastName': 'Carlsson', 'Affiliation': 'Department of Radiation Sciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Bjartell', 'Affiliation': 'Division of Urological Cancers, Department of Translational Medicine, Lund University, Malmö, Sweden.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Nilsson', 'Affiliation': 'Department of Translational Medicine, Infectious Diseases Research Unit, Lund University, Malmö, Sweden.'}, {'ForeName': 'Clas', 'Initials': 'C', 'LastName': 'Ahlm', 'Affiliation': 'Department of Clinical Microbiology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anne-Marie Fors', 'Initials': 'AF', 'LastName': 'Connolly', 'Affiliation': 'The Laboratory for Molecular Infection Medicine Sweden, Umeå, Sweden; Department of Clinical Microbiology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Överby', 'Affiliation': 'The Laboratory for Molecular Infection Medicine Sweden, Umeå, Sweden; Department of Clinical Microbiology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Josefsson', 'Affiliation': 'Institute of Clinical Sciences, Department of Urology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Surgical and Perioperative Sciences, Urology & Andrology, Umeå University, Umeå, Sweden; Wallenberg Center for Molecular Medicine (WCMM), Umeå University, Umeå, Sweden. Electronic address: andreas.josefsson@umu.se.'}]",European urology,['10.1016/j.eururo.2021.12.013']
1599,34392115,Improving mental health in low-resource settings: A feasibility randomized controlled trial of a transdiagnostic psychological intervention among Burundian refugee adolescents and their caregivers.,"There is a paucity of evidence regarding interventions that can improve the mental health of adversity-affected young adolescents living in low-resource settings. We evaluated the feasibility, acceptability, relevance, and safety of the World Health Organization's Early Adolescent Skills for Emotions (EASE) intervention among Burundian refugee adolescents and their caregivers in Tanzania. This study consisted of a feasibility cluster randomized controlled trial (cRCT) and a process evaluation. The feasibility cRCT included 82 young adolescents and their 64 caregivers, with two clusters randomized to EASE and two to an enhanced control condition. EASE was delivered by adult refugees without prior training in mental health. The process evaluation consisted of 36 semi-structured qualitative interviews with key stakeholders, including adolescents, caregivers, and facilitators. EASE participants and facilitators gave positive feedback about its format, accessibility, and content. Trained non-specialist refugee facilitators were able to deliver EASE with high fidelity. The research protocol functioned well in terms of balanced randomization, limited loss to follow-up, and psychometrically promising measures, but discordance was observed between the short screener and psychological distress symptom checklist. This formative study suggests the potential of EASE in targeting psychological distress among displaced young adolescents and lays the groundwork for a future definitive trial.",2021,"The research protocol functioned well in terms of balanced randomization, limited loss to follow-up, and psychometrically promising measures, but discordance was observed between the short screener and psychological distress symptom checklist.","['Burundian refugee adolescents and their caregivers in Tanzania', '82 young adolescents and their 64 caregivers, with two clusters randomized to EASE and two to an enhanced control condition', 'displaced young adolescents', 'Burundian refugee adolescents and their caregivers']","['transdiagnostic psychological intervention', ""World Health Organization's Early Adolescent Skills for Emotions (EASE) intervention"", 'EASE']","['mental health', 'feasibility, acceptability, relevance, and safety']","[{'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",82.0,0.0684711,"The research protocol functioned well in terms of balanced randomization, limited loss to follow-up, and psychometrically promising measures, but discordance was observed between the short screener and psychological distress symptom checklist.","[{'ForeName': 'Shoshanna L', 'Initials': 'SL', 'LastName': 'Fine', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Baltimore, MD, 21205, USA. Electronic address: slfine@jhu.edu.'}, {'ForeName': 'Aiysha', 'Initials': 'A', 'LastName': 'Malik', 'Affiliation': 'World Health Organization, Avenue Appia 20, 1211, Geneva, Switzerland.'}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Guimond', 'Affiliation': 'International Rescue Committee, 122 East 42nd St., New York, NY, 10168, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Nemiro', 'Affiliation': 'International Rescue Committee, 122 East 42nd St., New York, NY, 10168, USA.'}, {'ForeName': 'Getruda', 'Initials': 'G', 'LastName': 'Temu', 'Affiliation': 'International Rescue Committee, 122 East 42nd St., New York, NY, 10168, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Likindikoki', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, P.O. Box 65001, Dar es Salaam, Tanzania.'}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Annan', 'Affiliation': 'International Rescue Committee, 122 East 42nd St., New York, NY, 10168, USA.'}, {'ForeName': 'Wietse A', 'Initials': 'WA', 'LastName': 'Tol', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Baltimore, MD, 21205, USA; Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1353, Copenhagen, Denmark; HealthRight International, 14 East 14th St., New York, NY, 10012, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.103944']
1600,34972033,Areas of cerebral blood flow changes on arterial spin labelling with the use of symmetric template during nitroglycerin triggered cluster headache attacks.,"BACKGROUND


Cluster headache is a rare, strictly unilateral, severe episodic primary headache disorder. Due to the unpredictable and episodic nature of the attacks, nitroglycerin has been used to trigger attacks for research purposes to further our understanding of cluster headache pathophysiology.
OBJECTIVES


We aimed to identify regions of significant cerebral blood flow (CBF) changes during nitroglycerin triggered cluster headache attacks, using MRI with arterial spin labelling (ASL).
METHODS


Thirty-three subjects aged 18-60 years with episodic and chronic cluster headache were recruited and attended an open clinical screening visit without scanning to receive an intravenous nitroglycerin infusion (0.5 μg/kg/min over 20 min). Those for whom nitroglycerin successfully triggered a cluster headache attack, were invited to attend two subsequent scanning visits. They received either single-blinded intravenous nitroglycerin (0.5 μg/kg/min) or an equivalent volume of single-blinded intravenous 0.9% sodium chloride over a 20-minute infusion. Whole-brain CBF maps were acquired using a 3 Tesla MRI scanner pre-infusion and post-infusion. As cluster headache is a rare condition and purely unilateral disorder, an analysis strategy to ensure all the image data corresponded to symptomatology in the same hemisphere, without losing coherence across the group, was adopted. This consisted of spatially normalising all CBF maps to a standard symmetric reference template before flipping the images about the anterior-posterior axis for those CBF maps of subjects who experienced their headache in the right hemisphere. This procedure has been employed in previous studies and generated a group data set with expected features on the left hemisphere only.
RESULTS


Twenty-two subjects successfully responded to the nitroglycerin infusion and experienced triggered cluster headache attacks. A total of 20 subjects completed the placebo scanning visit, 20 completed the nitroglycerin scanning visit, and 18 subjects had completed both the nitroglycerin and placebo scanning visits. In a whole-brain analysis, we identified regions of significantly elevated CBF in the medial frontal gyrus, superior frontal gyrus, inferior frontal gyrus and cingulate gyrus, ipsilateral to attack side, in CBF maps acquired during cluster headache attack; compared with data from the placebo session. We also identified significantly reduced CBF in the precuneus, cuneus, superior parietal lobe and occipital lobe contralateral to the attack side. Of particular interest to this field of investigation, both the hypothalamus and ipsilateral ventral pons showed higher CBF in a separate region of interest analysis.
CONCLUSION


Our data demonstrate that severe cluster headache leads to significant increases in regional cerebral perfusion, likely to reflect changes in neuronal activity in several regions of the brain, including the hypothalamus and the ventral pons. These data contribute to our understanding of cluster headache pathophysiology; and suggest that non-invasive ASL technology may be valuable in future mechanistic studies of this debilitating condition.",2022,"In a whole-brain analysis, we identified regions of significantly elevated CBF in the medial frontal gyrus, superior frontal gyrus, inferior frontal gyrus and cingulate gyrus, ipsilateral to attack side, in CBF maps acquired during cluster headache attack; compared with data from the placebo session.","['Thirty-three subjects aged 18-60\xa0years with episodic and chronic cluster headache were recruited and attended an open clinical screening visit without scanning to receive an', '20 subjects completed the placebo scanning visit, 20 completed the nitroglycerin scanning visit, and 18 subjects had completed both the']","['equivalent volume of single-blinded intravenous 0.9% sodium chloride', 'nitroglycerin and placebo scanning visits', 'MRI with arterial spin labelling (ASL', 'intravenous nitroglycerin infusion', 'nitroglycerin']","['cluster headache attacks', 'cluster headache attack', 'cerebral blood flow (CBF) changes', 'regional cerebral perfusion']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0009088', 'cui_str': 'Cluster headache'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0990166', 'cui_str': 'Sodium Chloride 0.154 MEQ/ML'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0009088', 'cui_str': 'Cluster headache'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",33.0,0.09085,"In a whole-brain analysis, we identified regions of significantly elevated CBF in the medial frontal gyrus, superior frontal gyrus, inferior frontal gyrus and cingulate gyrus, ipsilateral to attack side, in CBF maps acquired during cluster headache attack; compared with data from the placebo session.","[{'ForeName': 'Diana Y', 'Initials': 'DY', 'LastName': 'Wei', 'Affiliation': ""Headache Group, Wolfson Centre for Age-Related Diseases, King's College London, UK; NIHR Wellcome Trust King's Clinical Research Facility, King's College Hospital, London, UK.""}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': ""O'Daly"", 'Affiliation': ""Centre for Neuroimaging Sciences, Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Fernando O', 'Initials': 'FO', 'LastName': 'Zelaya', 'Affiliation': ""Centre for Neuroimaging Sciences, Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""Headache Group, Wolfson Centre for Age-Related Diseases, King's College London, UK; NIHR Wellcome Trust King's Clinical Research Facility, King's College Hospital, London, UK; Department of Neurology, University of California, Los Angeles, CA, USA. Electronic address: peter.goadsby@kcl.ac.uk.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2021.102920']
1601,34973410,Effect of Website-based Learning on Improved Monitoring of Adverse Drug Reactions by Clinical Nurses.,"PURPOSE


The purpose of this study was to develop website-based learning contents to activate voluntary monitoring and reporting of adverse drug reactions (ADRs) for clinical nurses and to verify their effectiveness.
METHOD


Using a quasi-experimental control group pretest-posttest design with random allocation, a total of 60 nurses with more than 1 year of clinical experience were recruited from a university hospital in Seoul, Korea. A website was developed that provides learning contents including real cases and the latest drug-related knowledge, as well as video lectures. Knowledge on ADR monitoring, self-efficacy, ADR practice behavior, and medication performance ability were measured at 2 weeks after intervention. A small notebook for monitoring ADRs of nurses was given to the control group. Data were analyzed using descriptive statistics, the chi-squared test, and the independent t test using SPSS Statistics Software Version 21.0.
RESULTS


The scores of ADR monitoring knowledge, self-efficacy, and ADR monitoring practice in the experimental group significantly increased after the intervention compared with the control group (p < .05). However, there was no significant difference between the two groups in medication performance ability related to ADR monitoring.
CONCLUSION


To spread a safety culture in which voluntary ADR monitoring and reporting is activated, it is necessary for clinical nurses to share and communicate ADR-related information and real cases through an open website.",2022,"The scores of ADRs monitoring knowledge, self-efficacy, and ADRs monitoring practice in the experimental group significantly increased after the intervention compared with the control group (p<.05).","['Clinical Nurses', '60 nurses with more than 1 year of clinical experience were recruited from a university hospital in Seoul, Korea']",['Website-based Learning'],"['Knowledge on ADRs monitoring, self-efficacy, ADRs practice behavior, and medication performance ability', 'scores of ADRs monitoring knowledge, self-efficacy, and ADRs monitoring practice']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]",60.0,0.0239169,"The scores of ADRs monitoring knowledge, self-efficacy, and ADRs monitoring practice in the experimental group significantly increased after the intervention compared with the control group (p<.05).","[{'ForeName': 'Hyun Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Honam University, Gwangju, Republic of Korea. Electronic address: 2020100@honam.ac.kr.'}, {'ForeName': 'Seon Young', 'Initials': 'SY', 'LastName': 'Hwang', 'Affiliation': 'School of Nursing, Hanyang University, Seoul, Republic of Korea. Electronic address: seon9772@hanyang.ac.kr.'}]",Asian nursing research,['10.1016/j.anr.2021.12.004']
1602,34971304,Effect of the local application of bupivacaine in early pain control following impacted mandibular third molar surgery: A randomized controlled study.,"BACKGROUND


Postoperative pain is one of the main complications following impacted mandibular third molar (IMTM) surgery.
OBJECTIVES


The aim of this study was to assess the effect of the local application of bupivacaine on reducing early postoperative pain following IMTM surgery.
MATERIAL AND METHODS


A prospective, single-blinded, randomized controlled study was conducted on 40 patients who had undergone the surgical removal of an IMTM under local anesthesia. In the study group (n = 20), absorbable gelatin sponge (AGS) soaked in 3 mL of 0.5% plain bupivacaine hydrochloride was locally applied in the post-extraction socket. In the control group (n = 20), AGS soaked in 3 mL of normal saline was used. Pain intensity was assessed using a pain numerical rating scale (NRS) 4 and 12 h postoperatively. The variables were compared between the 2 groups and probability values <0.05 were considered statistically significant.
RESULTS


The pain scores in the study group were significantly lower than those recorded in the control group at 4 h postoperatively (p = 0.003), whereas the difference in the pain scores between the 2 groups 12 h after surgery was not statistically significant (p = 0.443).
CONCLUSIONS


The local application of bupivacaine is effective in reducing postoperative pain 4 h after the surgical extraction of IMTMs without any significant complications.",2021,The local application of bupivacaine is effective in reducing postoperative pain 4 h after the surgical extraction of IMTMs without any significant complications.,"['40 patients who had undergone the surgical removal of an IMTM under local anesthesia', 'early pain control following impacted mandibular third molar surgery']","['AGS soaked in 3 mL of normal saline', 'absorbable gelatin sponge (AGS) soaked in 3 mL of 0.5% plain bupivacaine hydrochloride', 'bupivacaine']","['pain numerical rating scale (NRS', 'early postoperative pain', 'Pain intensity', 'pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0017238', 'cui_str': 'absorbable gelatin sponge'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",40.0,0.106958,The local application of bupivacaine is effective in reducing postoperative pain 4 h after the surgical extraction of IMTMs without any significant complications.,"[{'ForeName': 'Mohanad Ali', 'Initials': 'MA', 'LastName': 'Shabat', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Baghdad, Baghdad Medical City, Bab-Almoadham, Baghdad, Iraq.'}, {'ForeName': 'Salwan Yousif', 'Initials': 'SY', 'LastName': 'Bede', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Baghdad, Baghdad Medical City, Bab-Almoadham, Baghdad, Iraq.'}]",Dental and medical problems,['10.17219/dmp/133664']
1603,34971551,"Novel Parathyroid Hormone-Based Bone Graft, KUR-113, in Treatment of Acute Open Tibial Shaft Fracture: A Phase-2 Randomized Controlled Trial.","BACKGROUND


Treatment of an open tibial shaft fracture (TSF) is complex, and many cases are associated with delayed bone union or malunion. Parathyroid hormone (PTH) plays a key role in bone metabolism. A peptide fragment of PTH (PTH1-34) has been shown to promote bone healing. The objective of this study was to evaluate the safety and efficacy of a novel PTH-based bone graft (KUR-113) in the treatment of subjects with an open TSF.
METHODS


The study was a randomized, controlled, open-label (dose-blinded), dose-finding study of 200 subjects who had an open TSF secondary to trauma. Subjects were randomized into 1 of 4 groups to receive the standard of care (SoC) alone (control) or the SoC plus a single application of 4 mL of KUR-113 containing TGplPTH1-34 in fibrin at a concentration of 0.133 mg/mL (KUR-113-low), 0.4 mg/mL (KUR-113-mid), or 1.0 mg/mL (KUR-113-high). KUR-113 was administered at the fracture site after internal fracture fixation and before wound closure. Subjects were followed for up to 12 months after treatment. The primary outcome measure was fracture healing at 6 months assessed by the study investigator using radiographic and clinical measures. The primary end point was the proportion of subjects with fracture healing at 6 months.
RESULTS


A total of 200 subjects were enrolled and randomized to 1 of the 4 treatments. The primary end point was met in the KUR-113-mid group, which showed a significantly higher prevalence of healing at 6 months than the control group (37 of 46; 80.4% versus 31 of 48; 64.6%). By 12 months, healing had occurred in the majority of subjects in all treatment groups, with the control group requiring more surgical interventions to achieve fracture healing. Adverse events occurred at similar frequencies between the KUR-113 groups and the SoC group. No ectopic bone formation or abnormal bone resorption at the fracture site was observed in any of the treatment groups.
CONCLUSIONS


KUR-113 has the potential to be a good adjunctive therapy in the treatment of open TSFs.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2022,"By 12 months, healing had occurred in the majority of subjects in all treatment groups, with the control group requiring more surgical interventions to achieve fracture healing.","['subjects with an open TSF', 'A total of 200 subjects', 'Acute Open Tibial Shaft Fracture', '200 subjects who had an open TSF secondary to trauma']","['KUR-113', 'Parathyroid hormone (PTH', 'Novel Parathyroid Hormone-Based Bone Graft, KUR-113', 'standard of care (SoC) alone (control) or the SoC plus a single application of 4 mL of KUR-113 containing TGplPTH1-34 in fibrin at a concentration of 0.133 mg/mL (KUR-113-low), 0.4 mg/mL (KUR-113-mid), or 1.0 mg/mL (KUR-113-high', 'novel PTH-based bone graft (KUR-113']","['ectopic bone formation or abnormal bone resorption', 'fracture healing', 'healing', 'safety and efficacy', 'prevalence of healing', 'proportion of subjects with fracture healing', 'Adverse events']","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0588199', 'cui_str': 'Bone structure of shaft of tibia'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0574352', 'cui_str': 'Kurdish language'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0029396', 'cui_str': 'Heterotopic ossification'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",200.0,0.0569521,"By 12 months, healing had occurred in the majority of subjects in all treatment groups, with the control group requiring more surgical interventions to achieve fracture healing.","[{'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Orbeanu', 'Affiliation': 'Balzerborn Kliniken, Bad Elster, Germany.'}, {'ForeName': 'Horia', 'Initials': 'H', 'LastName': 'Haragus', 'Affiliation': 'Department of Orthopedics, Victor Babes University of Medicine and Pharmacy, Timisoara, Romania.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Crisan', 'Affiliation': 'Department of Orthopedics, Victor Babes University of Medicine and Pharmacy, Timisoara, Romania.'}, {'ForeName': 'Catalin', 'Initials': 'C', 'LastName': 'Cirstoiu', 'Affiliation': 'Emergency Hospital, Bucharest, Romania.'}, {'ForeName': 'Branko', 'Initials': 'B', 'LastName': 'Ristic', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, University of Kragujevac, Serbia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Jamieson', 'Affiliation': 'Kuros Biosciences AG, Schlieren, Switzerland.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.02109']
1604,34975146,Energy balance in hypothalamic obesity in response to treatment with a once-weekly GLP-1 receptor agonist.,"BACKGROUND/OBJECTIVES


Hypothalamic obesity (HO) frequently occurs following suprasellar tumors from a combination of decreased energy expenditure and increased energy intake. Glucagon-like peptide-1 receptor agonist (GLP1RA) therapy is associated with increased satiety and energy expenditure. We hypothesized GLP1RA therapy in patients with HO would cause both lower energy intake and increased energy expenditure.
SUBJECTS/METHODS


Forty-two patients aged 10-26 years (median 16 years) with HO with suprasellar tumors were randomized to GLP1RA (exenatide extended release once-weekly, ExQW, n = 23) or placebo (n = 19). Thirty seven (81%) patients completed the 36-week double-blind placebo-controlled trial. Total energy expenditure (TEE) was measured with doubly labeled water, physical activity was assessed with actigraphy, and intake was estimated with ad libitum buffet meal. Results are presented as adjusted mean between-group difference.
RESULTS


As compared with treatment with placebo, treatment with ExQW was associated with decreased energy intake during a buffet meal (-1800 kJ (-430 kcal), 95% CI -3 184 to -418 kJ, p = 0.02). There were no significant differences in physical activity between groups. ExQW (vs. placebo) treatment was associated with a decrease in TEE (-695 kJ/day (-166 kcal/day), 95% CI -1 130 to -264 kJ/day, p < 0.01, adjusted for baseline TEE). The treatment effect was still significant after further adjustment for change in body composition (-372 kJ/day (-89 kcal/day), 95% CI -699 to -42 kJ/day, p = 0.04) or change in leptin (-695 kJ/day (-166 kcal/day), 95% CI -1 130 to -264 kJ/day, p < 0.01). This decrease in TEE occurred despite an increase in lean mass and fat mass (1.7 vs. 1.3 kg lean mass, p = 0.88 and 1.5 vs. 4.6 kg fat mass, p = 0.04, ExQW vs. placebo).
CONCLUSIONS


Treatment with a GLP1RA was associated with a decrease in food intake but also a decrease in TEE that was disproportionate to change in body composition.",2022,Glucagon-like peptide-1 receptor agonist (GLP1RA) therapy is associated with increased satiety and energy expenditure.,"['patients with HO', 'Thirty seven (81%) patients completed the 36-week double-blind', 'Forty-two patients aged 10-26 years (median 16 years) with HO with suprasellar tumors']","['GLP1RA', 'placebo', 'ExQW', 'Glucagon-like peptide-1 receptor agonist (GLP1RA) therapy', 'ExQW (vs. placebo', 'GLP1RA therapy', 'exenatide extended release once-weekly, ExQW, n\u2009=\u200923) or placebo']","['physical activity', 'lean mass and fat mass', 'Total energy expenditure (TEE', 'TEE', 'energy intake', 'change in leptin', 'food intake', 'body composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271885', 'cui_str': 'Hypothalamic obesity'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0230054', 'cui_str': 'Structure of suprasellar region'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",42.0,0.17659,Glucagon-like peptide-1 receptor agonist (GLP1RA) therapy is associated with increased satiety and energy expenditure.,"[{'ForeName': 'Ashley H', 'Initials': 'AH', 'LastName': 'Shoemaker', 'Affiliation': 'Vanderbilt University Medical Center, Division of Pediatric Endocrinology, Nashville, TN, 37212, USA. Ashley.H.Shoemaker@VUMC.org.'}, {'ForeName': 'Heidi J', 'Initials': 'HJ', 'LastName': 'Silver', 'Affiliation': 'Vanderbilt University Medical Center, Division of Gastroenterology, Hepatology and Nutrition Nashville, Nashville, TN, 37212, USA.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Buchowski', 'Affiliation': 'Vanderbilt University Medical Center, Division of Gastroenterology, Hepatology and Nutrition Nashville, Nashville, TN, 37212, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Slaughter', 'Affiliation': 'Vanderbilt University Medical Center, Department of Biostatistics, Nashville, TN, 37212, USA.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Yanovski', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 10 Center Drive, Room 1-3330, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Clinton', 'Initials': 'C', 'LastName': 'Elfers', 'Affiliation': ""Seattle Children's Research Institute, 1900 Ninth Ave, Seattle, WA, 98101, USA.""}, {'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Roth', 'Affiliation': ""Seattle Children's Research Institute, 1900 Ninth Ave, Seattle, WA, 98101, USA.""}, {'ForeName': 'M Jennifer', 'Initials': 'MJ', 'LastName': 'Abuzzahab', 'Affiliation': ""McNeely Pediatric Diabetes Center and Endocrinology Clinic, Children's Minnesota, St. Paul, MN, 55102, USA.""}]",International journal of obesity (2005),['10.1038/s41366-021-01043-6']
1605,34971819,"Comparison of three irrigation methods: SWEEPS, ultrasonic, and traditional irrigation, in smear layer and debris removal abilities in the root canal, beyond the fractured instrument.","BACKGROUND


:This study compared the effectiveness of three irrigation methods in removing smear layer and debris in the presence of the fractured instrument. The three compared irrigation methods were conventional syringe irrigation, passive ultrasonic irrigation, and SWEEPS (Shock wave enhanced emission photoacoustic streaming) irrigation.
METHODS AND MATERIALS


Sixty-three permanent mandibular molars with moderate curvature were included in this experimental study. Mesiobuccal root canals were prepared with Race files (FKG Dentaire. Switzerland) up to #25, 4%. A #30, 6% Race file was used to simulate file fracture 3 mm short of working length. The prepared samples, randomly divided into three groups, and final irrigation was separately done in each group. Group 1 conventional syringe irrigation (CSI) as the control group, Group 2 passive ultrasonic irrigation (PUI), and Group 3 Shock wave enhanced emission photoacoustic streaming or SWEEPS Irrigation (SI). Smear layer and debris removal beyond separated file scored with scanning electron microscope(SEM) images. Data were analyzed using the nonparametric tests to compare the smear layer and debris scores.
RESULT


SWEEPS and passive ultrasonic irrigation significantly removed smear layer and debris, better than conventional syringe irrigation (p<0.001). The smear layer and debris removal efficiency between passive ultrasonic Irrigation and SWEEPS were not significantly different (p = 0.629).
CONCLUSION


In the face of the irretrievably broken instrument in the root canal, passive ultrasonic irrigation and the SWEEPS method can enhance smear layer and debris removal compared to conventional syringe irrigation.",2022,"significantly removed smear layer and debris, better than conventional syringe irrigation (p<0.001).",['Sixty-three permanent mandibular molars with moderate curvature'],"['conventional syringe irrigation, passive ultrasonic irrigation, and SWEEPS (Shock wave enhanced emission photoacoustic streaming) irrigation', 'conventional syringe irrigation (CSI', 'conventional syringe irrigation', 'passive ultrasonic irrigation (PUI), and Group 3 Shock wave enhanced emission photoacoustic streaming or SWEEPS Irrigation (SI', 'passive ultrasonic irrigation']",['smear layer and debris removal efficiency'],"[{'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",63.0,0.0214286,"significantly removed smear layer and debris, better than conventional syringe irrigation (p<0.001).","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Vatanpour', 'Affiliation': 'Endodontic Department, Dental School, Islamic Azad University of Medical Sciences, Tehran, Iran. Electronic address: m.vatanpour@iautmu.ac.ir.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Toursavadkouhi', 'Affiliation': 'Endodontic Department, Dental School, Islamic Azad University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Sajjad', 'Affiliation': 'Endodontic Department, Dental School, Islamic Azad University of Medical Sciences, Tehran, Iran. Electronic address: shirin_sajjad@yahoo.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102707']
1606,34973809,"""Answers in hours"": A prospective clinical study using nanopore sequencing for bile duct cultures.","BACKGROUND


Surgical site infection is a major source of morbidity in patients undergoing pancreatic head resection and is often from organisms in intraoperative bile duct cultures. As such, many institutions use prolonged prophylactic antibiotics and tailor based on bile duct cultures. However, standard cultures take days, leaving many patients unnecessarily on prolonged antibiotics. Nanopore sequencing can provide data in hours and, thus, has the potential to improve antibiotic stewardship. The present study investigates the feasibility of nanopore sequencing in intraoperative bile samples.
METHODS


Patients undergoing pancreatic head resection were included. Intra-operative bile microbial profiles were determined with standard cultures and nanopore sequencing. Antibiotic recommendations were generated, and time-to-results determined for both methods. Organism yields, resistance patterns, antibiotic recommendations, and costs were compared.
RESULTS


Out of 42 patients, 22 (52%) had samples resulting in positive standard cultures. All positive standard cultures had microbes detected using nanopore sequencing. All 20 patients with negative standard cultures had negative nanopore sequencing. Nanopore sequencing detected more bacterial species compared to standard cultures (10.5 vs 4.4, p < 0.05) and more resistance genotypes (10.3 vs 2.7, p < 0.05). Antimicrobial recommendations based on nanopore sequencing provided coverage for standard cultures in 27 out of 44 (61%) samples, with broader coverage recommended by nanopore sequencing in 13 out of 27 (48%) of these samples. Nanopore sequencing results were faster (8 vs 98 hours) than standard cultures but had higher associated costs ($165 vs $38.49).
CONCLUSION


Rapid microbial profiling with nanopore sequencing is feasible with broader organism and resistance profiling compared to standard cultures. Nanopore sequencing has perfect negative predictive value and can potentially improve antibiotic stewardship; thus, a randomized control trial is under development.",2022,"Nanopore sequencing detected more bacterial species compared to standard cultures (10.5 vs 4.4, p < 0.05) and more resistance genotypes (10.3 vs 2.7, p < 0.05).","['Patients undergoing pancreatic head resection were included', 'All 20 patients with negative standard cultures had negative nanopore sequencing', 'patients undergoing pancreatic head resection']",[],"['Organism yields, resistance patterns, antibiotic recommendations, and costs', 'prolonged antibiotics', 'costs', 'resistance genotypes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0227579', 'cui_str': 'Structure of head of pancreas'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C5197920', 'cui_str': 'Nanopore Sequencing'}]",[],"[{'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}]",20.0,0.030577,"Nanopore sequencing detected more bacterial species compared to standard cultures (10.5 vs 4.4, p < 0.05) and more resistance genotypes (10.3 vs 2.7, p < 0.05).","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Yonkus', 'Affiliation': 'Division of Hepatobiliary & Pancreatic Surgery, Department of Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Whittle', 'Affiliation': 'Division of Surgical Research, Department of Surgery; Microbiome Program, Center for Individualized Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Alva-Ruiz', 'Affiliation': 'Division of Hepatobiliary & Pancreatic Surgery, Department of Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Amro M', 'Initials': 'AM', 'LastName': 'Abdelrahman', 'Affiliation': 'Division of Hepatobiliary & Pancreatic Surgery, Department of Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Horsman', 'Affiliation': 'Department of Pharmacy, College of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Gina A', 'Initials': 'GA', 'LastName': 'Suh', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Cunningham', 'Affiliation': 'Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Nelson', 'Affiliation': 'Division of Research and Optimal Patient Care, Cancer Programs, American College of Surgeons, Rochester, MN.'}, {'ForeName': 'Travis E', 'Initials': 'TE', 'LastName': 'Grotz', 'Affiliation': 'Division of Hepatobiliary & Pancreatic Surgery, Department of Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Rory L', 'Initials': 'RL', 'LastName': 'Smoot', 'Affiliation': 'Division of Hepatobiliary & Pancreatic Surgery, Department of Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Cleary', 'Affiliation': 'Division of Hepatobiliary & Pancreatic Surgery, Department of Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Nagorney', 'Affiliation': 'Division of Hepatobiliary & Pancreatic Surgery, Department of Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Kendrick', 'Affiliation': 'Division of Hepatobiliary & Pancreatic Surgery, Department of Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Truty', 'Affiliation': 'Division of Hepatobiliary & Pancreatic Surgery, Department of Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Chia', 'Affiliation': 'Division of Surgical Research, Department of Surgery; Microbiome Program, Center for Individualized Medicine, Mayo Clinic, Rochester, MN. Electronic address: Chia.nicholas@mayo.edu.'}]",Surgery,['10.1016/j.surg.2021.09.037']
1607,34973306,The effects of positive end-expiratory pressure (PEEP) application on optic nerve sheath diameter in patients undergoing laparoscopic cholecystectomy: a randomized trial.,"BACKGROUND


Positive end-expiratory pressure (PEEP) can overcome respiratory changes that occur during pneumoperitoneum application in laparoscopic procedures, but it can also increase intracranial pressure. We investigated PEEP vs. no PEEP application on ultrasound measurement of optic nerve sheath diameter (indirect measure of increased intracranial pressure) in laparoscopic cholecystectomy.
METHODS


Eighty ASA I-II patients aged between 18 and 60 years scheduled for elective laparoscopic cholecystectomy were included. The study was registered in the Australian New Zealand Clinical Trials (ACTRN12618000771257). Patients were randomly divided into either Group C (control, PEEP not applied), or Group P (PEEP applied at 10 cmH 2 0). Optic nerve sheath diameter, hemodynamic, and respiratory parameters were recorded at six different time points. Ocular ultrasonography was used to measure optic nerve sheath diameter.
RESULTS


Peak pressure (PPeak) values were significantly higher in Group P after application of PEEP (p = 0.012). Mean respiratory rate was higher in Group C at all time points after application of pneumoperitoneum (p < 0.05). The mean values of optic nerve sheath diameters measured at all time points were similar between the groups (p > 0.05). The pulmonary dynamic compliance value was significantly higher in group P as long as PEEP was applied (p = 0.001).
CONCLUSIONS


During laparoscopic cholecystectomy, application of 10 cmH 2 O PEEP did not induce a significant change in optic nerve sheath diameter (indirect indicator of intracranial pressure) compared to no PEEP application. It would appear that PEEP can be used safely to correct respiratory mechanics in cases of laparoscopic cholecystectomy, with no significant effect on optic nerve sheath diameter.",2021,Mean respiratory rate was higher in Group C at all time points after application of pneumoperitoneum (p < 0.05).,"['Eighty ASA I-II patients aged between 18 and 60 years scheduled for', 'patients undergoing laparoscopic cholecystectomy']","['Positive end-expiratory pressure (PEEP', 'PEEP', 'PEEP vs. no PEEP application', 'positive end-expiratory pressure (PEEP) application', 'Group C (control, PEEP not applied), or Group P (PEEP', 'Ocular ultrasonography', 'elective laparoscopic cholecystectomy']","['intracranial pressure', 'optic nerve sheath diameter (indirect indicator of intracranial pressure', 'mean values of optic nerve sheath diameters', 'Optic nerve sheath diameter, hemodynamic, and respiratory', 'Peak pressure (PPeak) values', 'Mean respiratory rate', 'pulmonary dynamic compliance value']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445116', 'cui_str': 'Not applied'}, {'cui': 'C0441849', 'cui_str': 'Group P'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0228673', 'cui_str': 'Optic nerve sheath structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance'}]",80.0,0.0301664,Mean respiratory rate was higher in Group C at all time points after application of pneumoperitoneum (p < 0.05).,"[{'ForeName': 'Seher', 'Initials': 'S', 'LastName': 'Yanatma', 'Affiliation': 'University of Health Science, Haydarpaşa Numune Research and Training Hospital, Department of Anesthesiology, İstanbul, Turkey. Electronic address: seheryanatma@hotmail.com.'}, {'ForeName': 'Reyhan', 'Initials': 'R', 'LastName': 'Polat', 'Affiliation': 'University of Health Science, Dışkapı Yıldırım Beyazıt Research and Training Hospital, Department of Anesthesiology, Ankara, Turkey.'}, {'ForeName': 'Mehmet Murat', 'Initials': 'MM', 'LastName': 'Sayın', 'Affiliation': 'University of Health Science, Dışkapı Yıldırım Beyazıt Research and Training Hospital, Department of Anesthesiology, Ankara, Turkey.'}, {'ForeName': 'Safinaz', 'Initials': 'S', 'LastName': 'Karabayırlı', 'Affiliation': 'Private İzmit Konak Hospital, Department of Anesthesiology, Kocaeli, Turkey.'}]",Brazilian journal of anesthesiology (Elsevier),['10.1016/j.bjane.2021.12.006']
1608,34942224,The effectiveness of computer-assisted Cognitive Behavioral Therapy (cCBT) for psychological outcomes in patients with laryngectomy: Randomized controlled trial.,"BACKGROUND


The symptom burden was tremendous and rates of psychological distress were high because of laryngectomy in Laryngeal carcinoma. Anxiety and depression as mainly psychological distress influenced their sleep, pain, and the quality of life (QOL). This study aimed to assess the effiacy of computer-assisted Cognitive Behavioral Therapy (cCBT) for psychological outcomes and QOL in patients with laryngectomy, in addition to overall experience with health care service, during the perioperative period.
METHODS


A cCBT program was be customized focused on improving anxiety and depressive symptoms among patients with laryngectomy, and then its effectiveness was assessed. Participants were randomly assigned to the TAU (treatment as usual) group (n=40) or CCBT group (cCBT+ TAU, n = 40). The primary outcome measures were the State Anxiety Inventory (SAI), Patients Health Questionnaire-9 (PHQ-9). The secondary outcome measures were the Athens Insomnia Scale (AIS), Visual Analogue Scale-10 (VAS-10). The outcomes were obtained from patients before intervention (T1), 1 hour before surgery (T2), postoperative 3-day (T3), postoperative 7-day (T4), and postoperative 10-day(T5: after intervention completed). Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) and satisfaction for health care service were assessed before discharge.
RESULTS


A mixed linear model displayed significant improvement in symptoms of anxiety, depression, insomnia, and pain in the two groups (all p<0.001); and revealed a significant decreasing on the SAI, PHQ-9, AIS, and VAS-10 scores in the CCBT group compared to that of TAU group during the post-intervention periods (all p<0.05). Furthermore, the other QOL of patients were higher except for physical well-being (p=0.176) and the satisfaction scores were higher in the CCBT group than that of TAU group (all p<0.05).
CONCLUSION


The new developed cCBT program has a positive effect on psychosomatic symptoms surgery-related among patients with laryngectomy,. And patients with cCBT program reported high levels of QOL and satisfaction during perioperative period. To minimize face-to-face contact, the computer-assisted intervention may be an attractive approach.",2022,"The new developed cCBT program has a positive effect on psychosomatic symptoms surgery-related among patients with laryngectomy,.","['patients with laryngectomy, in addition to overall experience with health care service, during the perioperative period', 'patients with laryngectomy']","['TAU', 'CCBT group (cCBT+ TAU', 'computer-assisted Cognitive Behavioral Therapy (cCBT', 'cCBT program']","['Anxiety and depression as mainly psychological distress influenced their sleep, pain, and the quality of life (QOL', 'anxiety and depressive symptoms', 'State Anxiety Inventory (SAI), Patients Health Questionnaire-9', 'SAI, PHQ-9, AIS, and VAS-10 scores', 'symptoms of anxiety, depression, insomnia, and pain', 'QOL and satisfaction', 'satisfaction scores', 'Athens Insomnia Scale (AIS), Visual Analogue Scale-10 (VAS-10', 'postoperative 3-day (T3), postoperative 7-day (T4), and postoperative 10-day(T5', 'Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) and satisfaction for health care service']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023065', 'cui_str': 'Laryngectomy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]",,0.0360007,"The new developed cCBT program has a positive effect on psychosomatic symptoms surgery-related among patients with laryngectomy,.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Nursing Department, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China; Shanxi Key Laboratory of Brain Science and Neuropsychiatric Diseases, China.'}, {'ForeName': 'Haibin', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of anesthesia, First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.'}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Nursing Department, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.'}, {'ForeName': 'Zhifen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.'}, {'ForeName': 'Xinrong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.'}, {'ForeName': 'Gaiping', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'Department of Head and Neck Surgery, Shanxi provincial Cancer Hospital, Taiyuan, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Shanxi Key Laboratory of Brain Science and Neuropsychiatric Diseases, China; Department of Psychiatry, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China. Electronic address: xuyongsmu@vip.163.com.'}, {'ForeName': 'Bin-Quan', 'Initials': 'BQ', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China. Electronic address: wbq_xy@126.com.'}]",Journal of affective disorders,['10.1016/j.jad.2021.12.068']
1609,34973810,Long-term retention after structured curriculum on attainment of critical view of safety during laparoscopic cholecystectomy for surgeons.,"BACKGROUND


Obtaining a clear Critical View of Safety helps prevent bile duct injuries during laparoscopic cholecystectomy, which can be improved with a structured Safe Critical View of Safety curriculum. We aimed to determine whether the improvement in obtaining Critical View of Safety postcurriculum is retained long-term.
METHODS


A safe Critical View of Safety curriculum was previously implemented for all surgeons who perform laparoscopic cholecystectomy at a regional health system. Recordings of laparoscopic cholecystectomy cases were collected 1 year after completion of the curriculum, deidentified and randomly ordered, and then graded by 2 blinded expert surgeons using a 6-point Critical View of Safety assessment tool.
RESULTS


A total of 12 surgeons with average experience of 17.9 ± 6.3 years in practice participated in the study. The majority (83%) had performed >700 laparoscopic cholecystectomies, and 4 surgeons (33%) reported 2 or more bile duct injuries in their career. Controlling for gallbladder pathology, Critical View of Safety scores improved from 1.7 ± 0.4 to 4.0 ± 0.4 (P < .001) immediately after completion of the curriculum. However, there was a small decrease in Critical View of Safety score after 1 year (3.2 ± 0.3 from 4.0 ± 0.4, P = .055), while still significantly higher compared to precurriculum (3.2 ± 0.3 vs 1.7 ± 0.4, P < .001). Acute care surgeons had lower Critical View of Safety retention scores compared to general surgeons (1.8 ± 0.5 vs 3.3 ± 0.4, P = .01) and minimally invasive surgeons (1.8 ± 0.5 vs 3.8 ± 0.5, P < .01).
CONCLUSION


A structured curriculum helped improve practicing surgeons' attainment of obtaining the Critical View of Safety during laparoscopic cholecystectomy. However, this improvement decreased after 1 year, suggesting some decay in knowledge retention over time. Therefore, continued educational interventions on Critical View of Safety and safe laparoscopic cholecystectomy may be needed to enhance long-term retention.",2022,"Acute care surgeons had lower Critical View of Safety retention scores compared to general surgeons (1.8 ± 0.5 vs 3.3 ± 0.4, P = .01) and minimally invasive surgeons (1.8 ± 0.5 vs 3.8 ± 0.5, P < .01).
","['laparoscopic cholecystectomy for surgeons', 'all surgeons who perform laparoscopic cholecystectomy at a regional health system', '12 surgeons with average experience of 17.9 ± 6.3 years in practice participated in the study']",['laparoscopic cholecystectomy'],"['Critical View of Safety score', 'Safety retention scores', 'bile duct injuries']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0434034', 'cui_str': 'Injury of bile duct'}]",12.0,0.0234769,"Acute care surgeons had lower Critical View of Safety retention scores compared to general surgeons (1.8 ± 0.5 vs 3.3 ± 0.4, P = .01) and minimally invasive surgeons (1.8 ± 0.5 vs 3.8 ± 0.5, P < .01).
","[{'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'Wong', 'Affiliation': 'Department of Surgery, NorthShore University HealthSystem, Evanston, IL; Department of Surgery, University of Chicago Medicine, IL. Electronic address: Harry.Wong@uchospitals.edu.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Department of Surgery, NorthShore University HealthSystem, Evanston, IL; Department of Surgery, Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Bailey', 'Initials': 'B', 'LastName': 'Su', 'Affiliation': 'Department of Surgery, NorthShore University HealthSystem, Evanston, IL; Department of Surgery, University of Chicago Medicine, IL.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Attaar', 'Affiliation': 'Department of Surgery, NorthShore University HealthSystem, Evanston, IL; Department of Surgery, University of Chicago Medicine, IL.'}, {'ForeName': 'Hoover', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Surgery, NorthShore University HealthSystem, Evanston, IL; Department of Surgery, University of Chicago Medicine, IL.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Department of Surgery, NorthShore University HealthSystem, Evanston, IL; Department of Surgery, University of Chicago Medicine, IL.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Kuchta', 'Affiliation': 'Department of Surgery, NorthShore University HealthSystem, Evanston, IL.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Linn', 'Affiliation': 'Department of Surgery, NorthShore University HealthSystem, Evanston, IL.'}, {'ForeName': 'Woody', 'Initials': 'W', 'LastName': 'Denham', 'Affiliation': 'Department of Surgery, NorthShore University HealthSystem, Evanston, IL.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Haggerty', 'Affiliation': 'Department of Surgery, NorthShore University HealthSystem, Evanston, IL.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Ujiki', 'Affiliation': 'Department of Surgery, NorthShore University HealthSystem, Evanston, IL.'}]",Surgery,['10.1016/j.surg.2021.08.063']
1610,34974918,Perceived Risk of Harm Mediates the Effects of Primary Care Alcohol Use Screening and Brief Advice in Adolescents.,"PURPOSE


A previous trial found lower alcohol use risk during follow-up among adolescent primary care patients receiving computer-facilitated Screening and provider Brief Advice (cSBA) compared to treatment-as-usual (TAU). We tested whether the effect was mediated by alcohol-related perceived risk of harm (PRoH).
METHODS


We analyzed data from the cSBA trial on 12- to 18-year-old patients at 9 New England practices (n = 2,096, 58% females). The trial used a quasi-experimental pre-post design with practices being their own controls (TAU followed by cSBA). Because prior alcohol experience could modify effects, we stratified analyses by baseline past 12-month drinking. Among baseline nondrinkers, we tested baseline to 3-month trajectories in PRoH of ""trying alcohol"" as an effect mediator for drinking at 3- and 12-month follow-up. Similarly, among those with prior drinking, we examined baseline to 3-month trajectories in PRoH of ""weekly binge drinking"" as an effect mediator for drinking and binge drinking. We used the Hayes product of coefficients mediation approach.
RESULTS


Among baseline nondrinkers (n = 1,449), cSBA had higher PRoH compared to TAU for ""trying alcohol,"" and higher PRoH in turn was associated with lower follow-up drinking risk. PRoH mediated their cSBA effect at 12 months, but not 3 months. Among adolescents with prior drinking (n = 647), cSBA had higher PRoH for ""weekly binge drinking,"" which was associated with lower drinking risk at both follow-ups, and lower binge drinking risk at 3 months. PRoH mediated their cSBA effect on drinking at both follow-ups, and binge drinking at 3 months.
CONCLUSION


A computer-facilitated primary care intervention enhanced adolescents' perceived alcohol risks which in turn was associated with lower drinking risk.",2022,"PRoH mediated their cSBA effect on drinking at both follow-ups, and binge drinking at 3 months.
","['Among baseline nondrinkers (n\xa0= 1,449', '12- to 18-year-old patients at 9 New England practices (n\xa0= 2,096, 58% females', 'adolescent primary care patients receiving', 'adolescents with prior drinking (n\xa0= 647', 'Adolescents']","['TAU', 'computer-facilitated primary care intervention', 'cSBA', 'computer-facilitated Screening and provider Brief Advice (cSBA', 'quasi-experimental pre-post design with practices being their own controls (TAU followed by cSBA']","['cSBA effect', 'risk of harm (PRoH', 'binge drinking risk']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027965', 'cui_str': 'Northeastern United States'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}]",,0.0414717,"PRoH mediated their cSBA effect on drinking at both follow-ups, and binge drinking at 3 months.
","[{'ForeName': 'Himani', 'Initials': 'H', 'LastName': 'Byregowda', 'Affiliation': ""Boston Children's Hospital, Division of Adolescent/Young Adult Medicine, Boston, Massachusetts.""}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Flynn', 'Affiliation': 'Health Resources in Action, Boston, Massachusetts.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Knight', 'Affiliation': ""Boston Children's Hospital, Division of Adolescent/Young Adult Medicine, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Sion K', 'Initials': 'SK', 'LastName': 'Harris', 'Affiliation': ""Boston Children's Hospital, Division of Adolescent/Young Adult Medicine, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts. Electronic address: sion.harris@childrens.harvard.edu.""}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2021.09.029']
1611,34979178,Daily steps and depressive symptoms: A longitudinal evaluation of patients with major depressive disorder in the precision medicine in mental health care study.,"BACKGROUND


Although the benefits of exercise on Major Depressive Disorder (MDD) are well established, longitudinal studies of objectively measured activity in clinical populations are needed to establish specific guidelines for exercise by persons with moderate-to-severe depression. This study examines the association between objectively assessed daily step count and depressive symptoms over a 24-week follow- up period in outpatients receiving treatment for moderate-to-severe depression.
METHODS


Participants were US Veterans with MDD enrolled in the Precision Medicine in Mental Health Care study (PRIME Care), a pragmatic, multi-site, randomized, controlled trial that examines the utility of genetic testing in the context of pharmacotherapy for MDD. Participants were a subset (N = 66) enrolled in actigraphy (using GT9X ActiGraph) monitoring component of the trial. Daily steps were examined as a predictor of depressive symptoms over 4-, 8-, 12-, 18-, and 24-weeks.
RESULTS


On average, participants took 3,460 (±1,768) steps per day. In generalized linear mixed models, an increase in 1,000 steps per day was associated with a 0.6-point decrease in depressive symptom severity at the subsequent follow-up assessment.
LIMITATIONS


Activity monitoring was observational and causal inferences cannot be made between daily steps and subsequent depressive symptom severity. Results may not generalize to non-treatment-seeking populations.
CONCLUSIONS


Study findings provide an initial metric for persons with clinically significant MDD, of whom most do not get sufficient daily activity. The findings can inform future trials aimed at determining how much daily activity is needed to improve symptoms in individuals with MDD.",2022,"In generalized linear mixed models, an increase in 1,000 steps per day was associated with a 0.6-point decrease in depressive symptom severity at the subsequent follow-up assessment.
","['outpatients receiving treatment for moderate-to-severe depression', 'individuals with MDD', 'patients with major depressive disorder in the precision medicine in mental health care study', 'Participants were a subset (N\xa0=\xa066) enrolled in actigraphy (using GT9X ActiGraph) monitoring component of the trial', 'Participants were US Veterans with MDD enrolled in the Precision Medicine in Mental Health Care study (PRIME Care), a pragmatic, multi-site', 'persons with moderate-to-severe depression']",[],"['depressive symptom severity', 'Daily steps and depressive symptoms', 'depressive symptoms']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2718059', 'cui_str': 'P Health'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",66.0,0.0836403,"In generalized linear mixed models, an increase in 1,000 steps per day was associated with a 0.6-point decrease in depressive symptom severity at the subsequent follow-up assessment.
","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Ramsey', 'Affiliation': 'VISN 4 Mental Illness, Research, Education, and Clinical Center, Corporal Michael J. Crescenz VA Medical Center, 5800 Woodland Ave, Philadelphia, PA 19130, United States; Yale School of Medicine, New Haven, CT, United States. Electronic address: christine.ramsey@va.gov.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Lynch', 'Affiliation': 'VISN 4 Mental Illness, Research, Education, and Clinical Center, Corporal Michael J. Crescenz VA Medical Center, 5800 Woodland Ave, Philadelphia, PA 19130, United States; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Gehrman', 'Affiliation': 'VISN 4 Mental Illness, Research, Education, and Clinical Center, Corporal Michael J. Crescenz VA Medical Center, 5800 Woodland Ave, Philadelphia, PA 19130, United States; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Vairavan', 'Affiliation': 'Neuroscience Data Science, Janssen Research & Development, LLC, Titusville, NJ, United States.'}, {'ForeName': 'Vaibhav A', 'Initials': 'VA', 'LastName': 'Narayan', 'Affiliation': 'Neuroscience Data Science, Janssen Research & Development, LLC, Titusville, NJ, United States; Science for Minds, Janssen Research & Development, LLC, Titusville, NJ, United States.'}, {'ForeName': 'Qingqin S', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'Neuroscience Data Science, Janssen Research & Development, LLC, Titusville, NJ, United States.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Oslin', 'Affiliation': 'VISN 4 Mental Illness, Research, Education, and Clinical Center, Corporal Michael J. Crescenz VA Medical Center, 5800 Woodland Ave, Philadelphia, PA 19130, United States; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2021.12.116']
1612,34984636,"Medicaid, Health, and the Moderating Role of Neighborhood Characteristics.","Neighborhood characteristics may moderate the effects of Medicaid coverage on health outcomes. Identifying this interplay can inform the design, targeting, and implementation of health policy. We combine data from the Oregon Health Insurance Experiment, which randomized access to Medicaid, with rich new data on multiple domains of neighborhood characteristics to assess the interaction between the local environment and the effect of insurance on health. Overall, we do not find that neighborhood characteristics substantially affect the relationship between gaining insurance and health outcomes, suggesting that Medicaid expansions are similarly effective across neighborhoods. This analysis highlights the complex relationship between health insurance coverage, neighborhood characteristics, and health.",2022,"Overall, we do not find that neighborhood characteristics substantially affect the relationship between gaining insurance and health outcomes, suggesting that Medicaid expansions are similarly effective across neighborhoods.",[],[],[],[],[],[],,0.0755544,"Overall, we do not find that neighborhood characteristics substantially affect the relationship between gaining insurance and health outcomes, suggesting that Medicaid expansions are similarly effective across neighborhoods.","[{'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Dennett', 'Affiliation': 'Yale University School of Public Health, New Haven, CT, USA. julia.dennett@yale.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Baicker', 'Affiliation': 'University of Chicago Harris School of Public Policy, Chicago, IL, USA.'}]",Journal of urban health : bulletin of the New York Academy of Medicine,['10.1007/s11524-021-00579-2']
1613,34984964,Health Bias in Clinical Work with Older Adult Clients: The Relation with Ageism and Aging Anxiety.,"OBJECTIVES


This experimental study examined health bias in mental health trainees' ratings of work with an older adult client and whether differences based on health were moderated by aging anxiety and ageist attitudes.
METHODS


Graduate-level mental health trainees ( N  = 488) were randomly assigned to read a vignette of an older adult client in good health or poor health, after which they rated aspects of clinical work with this client and completed measures of aging anxiety and ageist attitudes.
RESULTS


Trainees rated clinical work with the unhealthy older adult client more negatively than with the healthy older adult client. Health-based differences were larger at average and higher levels of ageist attitudes when considering the appropriateness of the client for therapy and at average and higher levels of aging anxiety for perceived competence to treat and comfort in treating the presenting complaint.
CONCLUSIONS


Trainees' health bias toward older adults may be magnified by higher aging anxiety and ageist attitudes. Training programs' intervention on these variables may improve geropsychological competencies of future mental health professionals.
CLINICAL IMPLICATIONS


Quality of mental health care for older adult clients may be compromised when biases about older adults, particularly those in poor health, are not addressed.",2022,"Health-based differences were larger at average and higher levels of ageist attitudes when considering the appropriateness of the client for therapy and at average and higher levels of aging anxiety for perceived competence to treat and comfort in treating the presenting complaint.
","['Older Adult Clients', 'older adult clients', ""mental health trainees' ratings of work with an older adult client"", 'Graduate-level mental health trainees ( N  =\xa0488']",['older adult client in good health or poor health'],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",[],488.0,0.0768656,"Health-based differences were larger at average and higher levels of ageist attitudes when considering the appropriateness of the client for therapy and at average and higher levels of aging anxiety for perceived competence to treat and comfort in treating the presenting complaint.
","[{'ForeName': 'Grace I L', 'Initials': 'GIL', 'LastName': 'Caskie', 'Affiliation': 'Department of Education and Human Services, Lehigh University, Bethlehem, Pennsylvania, USA.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Patterson', 'Affiliation': 'Department of Behavioral Health, Health Psychology, University of Wisconsin Medical Foundation, Madison, Wisconsin, USA.'}, {'ForeName': 'Abigail R', 'Initials': 'AR', 'LastName': 'Voelkner', 'Affiliation': 'Department of Education and Human Services, Lehigh University, Bethlehem, Pennsylvania, USA.'}]",Clinical gerontologist,['10.1080/07317115.2021.2019863']
1614,34962047,"Evaluating the tolerance and efficacy of laser-assisted delivery of tranexamic acid, niacinamide, and kojic acid for melasma: A single center, prospective, split-face trial.","Although many treatment options are available, the treatment of melasma remains challenging. To investigate the efficacy and safety of combined treatment for melasma with a quality (Q)-switched 1064-nm neodymium: yttrium-aluminum-garnet (Nd:YAG) laser and a topical mixture of tranexamic acid, niacinamide, and kojic acid. Twenty-five patients with melasma were enrolled. One side of the face was treated with low-fluence Q-switched 1064-nm Nd:YAG laser alone, while the other side was treated with a combination of laser treatment and a topical mixture of tranexamic acid, niacinamide, and kojic acid. Each treatment consisted of five sessions at 2-week intervals, and patients were followed up 4 weeks after the last treatment. Overall improvement was assessed using the hemi Melasma Area and Severity Index (MASI) score. A specialized imaging system (Markview®, PSIPLAUS Inc., Suwon, Korea) was used to record images of the patients' faces, and photographic assessment was performed by two independent evaluators at 2, 4, 6, 8, and 12 weeks using a five-point grading scale. Although both sides of the face showed clinical improvement, combination treatment demonstrated a greater improvement in the mean hemi MASI score compared to laser treatment alone. Improvement in melasma at 12 weeks, according to the evaluation of patient images by two independent evaluators, was greater with combination treatment. This study demonstrated that the combination of treatment with a low-fluence Q-switched 1064-nm Nd:YAG laser and a topical mixture of tranexamic acid, niacinamide, and kojic acid would be a good option for melasma treatment.",2022,"Although both sides of the face showed clinical improvement, combination treatment demonstrated a greater improvement in the mean hemi MASI score compared to laser treatment alone.","['melasma', 'Twenty-five patients with melasma were enrolled']","['neodymium: yttrium-aluminum-garnet (Nd:YAG) laser', 'low-fluence Q-switched 1064-nm Nd:YAG laser and a topical mixture of tranexamic acid, niacinamide, and kojic acid', 'topical mixture of tranexamic acid, niacinamide, and kojic acid', 'tranexamic acid, niacinamide, and kojic acid']","['efficacy and safety', 'mean hemi MASI score', 'hemi Melasma Area and Severity Index (MASI) score']","[{'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0064401', 'cui_str': 'kojic acid'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",25.0,0.0423748,"Although both sides of the face showed clinical improvement, combination treatment demonstrated a greater improvement in the mean hemi MASI score compared to laser treatment alone.","[{'ForeName': 'Su Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae Wan', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seong Jun', 'Initials': 'SJ', 'LastName': 'Seo', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kui Young', 'Initials': 'KY', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, South Korea.'}]",Dermatologic therapy,['10.1111/dth.15287']
1615,34986012,Effect of High-Power Laser Therapy Versus Shock Wave Therapy on Pain and Function in Knee Osteoarthritis Patients: A Randomized Controlled Trial.,"Objective:  The aim of this study was to evaluate and compare the effects of extracorporeal shock wave therapy (ESWT) and high-intensity laser therapy (HILT), as outpatient physical therapy modalities, on knee osteoarthritis (KOA) patients.  Materials and methods:  The treatment program was completed by 40 individuals with stage II KOA (according to Kellgren and Lawrence) who were randomly allocated to one of two groups. They have had more than grade 3 pain on the visual analog scale (VAS) during activities for the last 3 months, with body-mass index less than 30 and no history of knee operation, fracture, cancer, or other neuromuscular or musculoskeletal diseases that may affect study results. The ESWT group ( n  = 20, mean age = 40.12 ± 9.45 years) received ESWT, 0.05 mJ/mm 2 , one session/week for 4 weeks, and the HILT group ( n  = 20, mean age = 46.62 ± 8.68 years) received HILT, 1500 mJ/cm 2  in each session, three sessions/week for 4 weeks. Both groups received conservative physical therapy programs. Before and after 4 weeks of intervention, pain, physical function, and disability were assessed using a VAS, 6-min walking test, and the Western Ontario and McMaster Universities Osteoarthritis Index.  Results:  When the pre- and post-treatment mean values of dependent variables of both groups were compared, there were statistically significant improvements in both groups. Significant differences in the measured variables were also discovered in favor of the HILT group compared with the ESWT group.  Conclusions:  HILT showed a superior effect compared with ESWT on pain, physical function, and disability in chronic KOA patients. Pan African Clinical Trials Registry number: PACTR202007638955907.",2022,"They have had more than grade 3 pain on the visual analog scale (VAS) during activities for the last 3 months, with body-mass index less than 30 and no history of knee operation, fracture, cancer, or other neuromuscular or musculoskeletal diseases that may affect study results.","['Knee Osteoarthritis Patients', '40 individuals with stage II KOA (according to Kellgren and Lawrence', 'knee osteoarthritis (KOA) patients', 'chronic KOA patients']","['ESWT', 'High-Power Laser Therapy', 'conservative physical therapy programs', 'Shock Wave Therapy', 'extracorporeal shock wave therapy (ESWT) and high-intensity laser therapy (HILT']","['Pain and Function', 'pain, physical function, and disability', 'visual analog scale (VAS', 'pain, physical function, and disability were assessed using a VAS, 6-min walking test, and the Western Ontario and McMaster Universities Osteoarthritis Index']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}]",,0.0134236,"They have had more than grade 3 pain on the visual analog scale (VAS) during activities for the last 3 months, with body-mass index less than 30 and no history of knee operation, fracture, cancer, or other neuromuscular or musculoskeletal diseases that may affect study results.","[{'ForeName': 'Mohamed Serag Eldein Mahgoub', 'Initials': 'MSEM', 'LastName': 'Mostafa', 'Affiliation': 'Basic Sciences Department, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hamada Ahmed', 'Initials': 'HA', 'LastName': 'Hamada', 'Affiliation': 'Biomechanics Department, Faculty of Physical Therapy, Cairo University, Dokki, Egypt.'}, {'ForeName': 'Ahmed Mahmoud', 'Initials': 'AM', 'LastName': 'Kadry', 'Affiliation': 'Department of Integumentary Physical Therapy, Faculty of Physical Therapy, Kafrelsheikh University, Giza, Egypt.'}, {'ForeName': 'Samah Saad', 'Initials': 'SS', 'LastName': 'Zahran', 'Affiliation': 'Department of Musculoskeletal Disorders and Their Surgery, Faculty of Physical Therapy, Cairo University, Dokki, Egypt.'}, {'ForeName': 'Nesma Ahmed', 'Initials': 'NA', 'LastName': 'Helmy', 'Affiliation': 'Basic Science Department, Faculty of Physical Therapy, Beni-Suef University, Cairo, Egypt.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2021.0136']
1616,34404628,Primary Health Care Intervention Reduces Added Sugars Consumption During Childhood.,"OBJECTIVE


To investigate the effectiveness of a training program for health workers regarding infant feeding practices to reduce sugar consumption in children.
DESIGN


A cluster randomized trial was conducted at 20 health centers in southern Brazil randomly assigned to an intervention (n = 9) or control (n = 11) group.
PARTICIPANTS


The 715 pregnant women enrolled were assessed when their children were aged 6 months, 3 years, and 6 years.
INTERVENTION


A training session for primary care workers based on the Brazilian National Guidelines for Children.
MAIN OUTCOME MEASURE


Mothers were asked when sugar was first offered to children. Added sugars intake was obtained from dietary recalls.
ANALYSIS


The effectiveness of the intervention was modeled using generalized estimation equations and Poisson regression with robust variance.
RESULTS


Children attending intervention health centers had a 27% reduced risk of sugar introduction before 4 months of age (relative risk, 0.73; 95% confidence interval [CI], 0.61-0.87) as well as lower added sugars consumption (difference, -6.36 g/d; 95% CI, -11.49 to -1.23) and total daily energy intake (difference, -116.90 kcal/d; 95% CI, -222.41 to -11.40) at 3 years of age.
CONCLUSIONS AND IMPLICATIONS


Health care worker training in infant feeding guidelines may be an effective intervention to delay the introduction of added sugars and lower the subsequent intake of added sugars in infants and toddlers.",2021,"RESULTS


Children attending intervention health centers had a 27% reduced risk of sugar introduction before 4 months of age (relative risk, 0.73; 95% confidence interval [CI], 0.61-0.87) as well as lower added sugars consumption (difference, -6.36 g/d; 95% CI, -11.49 to -1.23) and total daily energy intake (difference, -116.90 kcal/d; 95% CI, -222.41 to -11.40) at 3 years of age.
","['20 health centers in southern Brazil randomly assigned to an intervention (n\u202f=\u202f9) or control (n\u202f=\u202f11) group', 'children', 'primary care workers based on the Brazilian National Guidelines for Children', 'health workers regarding infant feeding practices', '715 pregnant women enrolled were assessed when their children were aged 6 months, 3 years, and 6 years']",['training program'],"['added sugars consumption', 'Added Sugars Consumption During Childhood', 'risk of sugar introduction', 'total daily energy intake']","[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",715.0,0.0595413,"RESULTS


Children attending intervention health centers had a 27% reduced risk of sugar introduction before 4 months of age (relative risk, 0.73; 95% confidence interval [CI], 0.61-0.87) as well as lower added sugars consumption (difference, -6.36 g/d; 95% CI, -11.49 to -1.23) and total daily energy intake (difference, -116.90 kcal/d; 95% CI, -222.41 to -11.40) at 3 years of age.
","[{'ForeName': 'Paola Seffrin', 'Initials': 'PS', 'LastName': 'Baratto', 'Affiliation': 'Graduate Program in Pediatrics, Child and Adolescent Health Care, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Julia Luzzi', 'Initials': 'JL', 'LastName': 'Valmórbida', 'Affiliation': 'Graduate Program in Pediatrics, Child and Adolescent Health Care, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Paula Dos Santos', 'Initials': 'PDS', 'LastName': 'Leffa', 'Affiliation': 'Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Caroline Nicola', 'Initials': 'CN', 'LastName': 'Sangalli', 'Affiliation': 'Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Carlos Alberto', 'Initials': 'CA', 'LastName': 'Feldens', 'Affiliation': 'Department of Pediatric Dentistry, Universidade Luterana do Brasil, Canoas, Brazil.'}, {'ForeName': 'Márcia Regina', 'Initials': 'MR', 'LastName': 'Vitolo', 'Affiliation': 'Graduate Program in Pediatrics, Child and Adolescent Health Care, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil; Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil. Electronic address: marciavitolo@hotmail.com.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2021.07.007']
1617,34861764,Professors' Perceptions and Evaluations of Students Who Do and Do Not Stutter Following Oral Presentations.,"PURPOSE


The purpose of this study was to examine the perceptual ratings and performance evaluations of students who do and do not stutter by professors who require oral presentations. Additionally, this study sought to investigate the influence of behaviors related to communication competence on perceptual and evaluative ratings.
METHOD


One hundred fifty-eight college instructors who require oral presentations in their classes participated in this study. Participants viewed one video of four possible randomized conditions: (a) presence of stuttering + low communication competence, (b) absence of stuttering + low communication competence, (c) presence of stuttering + high communication competence, and (d) absence of stuttering + high communication competence. Participants evaluated student performance against a standardized rubric and rated the student along 16 personality traits.
RESULTS


Results of separate 2 × 2 analyses of variance revealed professors' view and evaluate students presenting with high communication competence more positively overall, regardless as to whether stuttering is present or not. Significant interactions between fluency (i.e., presence vs. absence of stuttering) and communication competence (i.e., high vs. low) were found for negative personality traits, as well as delivery evaluation scores. The video for which the student stuttered and presented with low communication competence was rated more positively than the video for which the student did not stutter and presented with low communication competence.
CONCLUSIONS


Professors perceive and evaluate students who stutter differently from their nonstuttering peers, and those ratings are moderated by levels of communication competence. High-communication-competence behaviors improved perceptual and evaluation scores; however, in the presence of low-communication-competence behaviors, professors overcorrect in the form of positive feedback bias, which may have negative long-term academic consequences.",2022,"Significant interactions between fluency (i.e., presence vs. absence of stuttering) and communication competence (i.e., high vs. low) were found for negative personality traits, as well as delivery evaluation scores.","['Participants evaluated student performance against a standardized rubric and rated the student along 16 personality traits', 'One hundred fifty-eight college instructors who require oral presentations in their classes participated in this study', 'students who do and do not stutter by professors who require oral presentations', 'Students']","['stuttering + low communication competence, (b) absence of stuttering + low communication competence, (c) presence of stuttering + high communication competence, and (d) absence of stuttering + high communication competence']",['negative personality traits'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0233849', 'cui_str': 'Character trait finding'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0038506', 'cui_str': 'Stuttering'}]","[{'cui': 'C0038506', 'cui_str': 'Stuttering'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0233849', 'cui_str': 'Character trait finding'}]",,0.0191829,"Significant interactions between fluency (i.e., presence vs. absence of stuttering) and communication competence (i.e., high vs. low) were found for negative personality traits, as well as delivery evaluation scores.","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Werle', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Texas at Austin.'}, {'ForeName': 'Courtney T', 'Initials': 'CT', 'LastName': 'Byrd', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Texas at Austin.'}]","Language, speech, and hearing services in schools",['10.1044/2021_LSHSS-21-00069']
1618,34860575,The Effects of a Multitiered System of Language Support on Kindergarten Oral and Written Language: A Large-Scale Randomized Controlled Trial.,"PURPOSE


The purpose of this randomized controlled trial was to examine the effects of a multitiered system of language support (MTSLS) on kindergarteners' narrative retelling, personal stories, writing, and expository language.
METHOD


Participants were 686 kindergarten students from four school districts in the United States. Twenty-eight classrooms were randomly assigned to treatment ( n  = 337 students) or control ( n  = 349 students) conditions. The treatment group received 14 weeks of oral narrative language instruction using  Story Champs,  a multitiered language program. Classroom teachers delivered large group (Tier 1) instruction for 15-20 min a day for 4 weeks. After this short-duration whole-class instruction, speech-language pathologists began small group  Story Champs  (Tier 2) intervention with a random sample of students who did not make adequate progress from the large group instruction ( n  = 49). These students received Tier 2 intervention for 20 min twice a week in addition to continued Tier 1 instruction.
RESULTS


Results indicated that the students in the treatment group had significantly higher scores on all outcome measures compared to the students in the control group. Analyses of outcomes from the 49 students who received Tier 2 intervention compared to a matching sample of at-risk control students revealed that the treatment group had significantly higher scores on narrative retells, personal stories, and expository retells. When compared to matched average-performing and advanced-performing control peers, the students who received Tier 2 intervention had significantly higher narrative retell scores and no longer had significantly lower personal story, expository, or writing scores.
CONCLUSION


This effectiveness study demonstrated that MTSLS can lead to meaningful improvements in kindergarteners' oral and written language skills, even helping at-risk students catch up to high-achieving peers.",2022,"This effectiveness study demonstrated that MTSLS can lead to meaningful improvements in kindergarteners' oral and written language skills, even helping at-risk students catch up to high-achieving peers.","['49 students', 'Twenty-eight classrooms were randomly assigned to treatment ( n  = 337 students) or control ( n  = 349 students) conditions', 'Kindergarten Oral and Written Language', 'Participants were 686 kindergarten students from four school districts in the United States']","['MTSLS', 'short-duration whole-class instruction, speech-language pathologists began small group  Story Champs  (Tier 2) intervention', 'oral narrative language instruction using  Story Champs,  a multitiered language program', 'multitiered system of language support (MTSLS', 'Multitiered System of Language Support']","['personal story, expository, or writing scores', 'narrative retells, personal stories, and expository retells', 'narrative retell scores', ""kindergarteners' narrative retelling, personal stories, writing, and expository language""]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0334866', 'cui_str': 'Medical pathologist'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0033348', 'cui_str': 'Programming Languages'}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0023008', 'cui_str': 'Language'}]",28.0,0.0735899,"This effectiveness study demonstrated that MTSLS can lead to meaningful improvements in kindergarteners' oral and written language skills, even helping at-risk students catch up to high-achieving peers.","[{'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'Petersen', 'Affiliation': 'Department of Communication Disorders, Brigham Young University, Provo, UT.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Staskowski', 'Affiliation': 'Macomb Intermediate School District, MI.'}, {'ForeName': 'Trina D', 'Initials': 'TD', 'LastName': 'Spencer', 'Affiliation': 'Department of Child & Family Studies, University of South Florida, Tampa.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Foster', 'Affiliation': 'Department of Child & Family Studies, University of South Florida, Tampa.'}, {'ForeName': 'Mollie Paige', 'Initials': 'MP', 'LastName': 'Brough', 'Affiliation': 'Department of Communication Disorders, Brigham Young University, Provo, UT.'}]","Language, speech, and hearing services in schools",['10.1044/2021_LSHSS-20-00162']
1619,34989687,Sensitivity Treatments for Teeth with Molar Incisor Hypomineralization: Protocol for a Randomized Controlled Trial.,"BACKGROUND


The sensitivity of teeth with molar incisor hypomineralization (MIH) can affect children's quality of life and is a challenging problem for dentists. Remineralizing agents such as sodium fluoride varnish seem to reduce the sensitivity of teeth with MIH, but long-term clinical trials with large samples are still needed for more evidence about its effectiveness as a desensitizing agent before its clinical recommendation.
OBJECTIVE


This randomized clinical trial aims to compare three treatment interventions for teeth with MIH and hypersensitivity.
METHODS


A total of 60 children aged 6-10 years presenting with at least one first permanent molar with sensitivity and no loss of enamel will be randomly assigned to three groups: the control group (sodium fluoride varnish; Duraphat, Colgate); experimental group I (4% titanium tetrafluoride varnish); and experimental group II (a coating resin containing surface prereacted glass-ionomer filler; PRG Barrier Coat, Shofu). The sodium fluoride varnish and 4% titanium tetrafluoride varnish will be applied once per week for 4 consecutive weeks and the PRG Barrier Coat resin will be applied in the first session and the application will be simulated the following 3 weeks to guarantee the blinding of the study. The primary outcome will be sensitivity level measured at different moments (before each material application, immediately after application or simulation, and 1, 2, 4, and 6 months after the last application/simulation) by one examiner using the Wong-Baker FACES Pain Rating Scale, the Schiff Cold Air Sensitivity Scale, and the FLACC (Face, Legs, Activity, Cry, Consolability) scale. As secondary outcomes, parental satisfaction and child self-reported discomfort after the treatment will be measured with a questionnaire prepared by the researcher. The data will undergo statistical analysis and the significance level will be set at 5%.
RESULTS


The project was funded in 2018, and enrollment was completed in November 2019. The recruitment of participants is currently underway and the first results are expected to be submitted for publication in 2022.
CONCLUSIONS


If found effective in reducing the patient's sensitivity long term, these agents can be considered as a treatment choice, and the findings will contribute to the development of a treatment protocol for teeth with sensitivity due to MIH.
TRIAL REGISTRATION


Brazilian Registry of Clinical Trials Universal Trial Number U1111-1237-6720; https://tinyurl.com/mr4x82k9.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/27843.",2022,"Remineralizing agents such as sodium fluoride varnish seem to reduce the sensitivity of teeth with MIH, but long-term clinical trials with large samples are still needed for more evidence about its effectiveness as a desensitizing agent before its clinical recommendation.
","['Teeth with Molar Incisor Hypomineralization', 'teeth with MIH and hypersensitivity', '60 children aged 6-10 years presenting with at least one first permanent molar with sensitivity and no loss of enamel']","['sodium fluoride varnish and 4% titanium tetrafluoride varnish', 'control group (sodium fluoride varnish; Duraphat, Colgate); experimental group I (4% titanium tetrafluoride varnish', 'molar incisor hypomineralization (MIH']","['sensitivity level', 'parental satisfaction and child self-reported discomfort', 'Wong-Baker FACES Pain Rating Scale, the Schiff Cold Air Sensitivity Scale, and the FLACC (Face, Legs, Activity, Cry, Consolability) scale']","[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C2350038', 'cui_str': 'Molar incisor hypomineralization'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}]","[{'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0076741', 'cui_str': 'titanium tetrafluoride'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0058817', 'cui_str': 'Duraphat'}, {'cui': 'C2345900', 'cui_str': 'Colgate'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C2350038', 'cui_str': 'Molar incisor hypomineralization'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}]",60.0,0.166817,"Remineralizing agents such as sodium fluoride varnish seem to reduce the sensitivity of teeth with MIH, but long-term clinical trials with large samples are still needed for more evidence about its effectiveness as a desensitizing agent before its clinical recommendation.
","[{'ForeName': 'Fernanda L', 'Initials': 'FL', 'LastName': 'Mendonça', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Fabiana Giuseppina Di Campli', 'Initials': 'FGDC', 'LastName': 'Regnault', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Camilla C L', 'Initials': 'CCL', 'LastName': 'Di Leone', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Isabella C', 'Initials': 'IC', 'LastName': 'Grizzo', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Aliny', 'Initials': 'A', 'LastName': 'Bisaia', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Fragelli', 'Affiliation': ""Morphology and Children's Clinic Department, Araraquara Dental School, São Paulo State University, Araraquara, Brazil.""}, {'ForeName': 'Thais M', 'Initials': 'TM', 'LastName': 'Oliveira', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Magalhães', 'Affiliation': 'Department of Biological Sciences, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rios', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}]",JMIR research protocols,['10.2196/27843']
1620,34399427,Oxygen-enriched Air Decreases Ventilation during High-intensity Fin-swimming Underwater.,"Oxygen-enriched air is commonly used in the sport of SCUBA-diving and might affect ventilation and heart rate, but little work exists for applied diving settings. We hypothesized that ventilation is decreased especially during strenuous underwater fin-swimming when using oxygen-enriched air as breathing gas. Ten physically-fit divers (age: 25±4; 5 females; 67±113 open-water dives) performed incremental underwater fin-swimming until exhaustion at 4 m water depth with either normal air or oxygen-enriched air (40% O 2 ) in a double-blind, randomized within-subject design. Heart rate and ventilation were measured throughout the dive and maximum whole blood lactate samples were determined post-exercise. ANOVAs showed a significant effect for the factor breathing gas (F(1, 9)=7.52; P=0.023; η 2   p =0.455), with a lower ventilation for oxygen-enriched air during fin-swimming velocities of 0.6 m·s -1  (P=0.032) and 0.8 m·s -1  (P=0.037). Heart rate, lactate, and time to exhaustion showed no significant differences. These findings indicate decreased ventilation by an elevated oxygen fraction in the breathing gas when fin-swimming in shallow-water submersion with high velocity (>0.5 m·s -1 ). Applications are within involuntary underwater exercise or rescue scenarios for all dives with limited gas supply.",2022,"Heart rate, lactate, and time to exhaustion showed no significant differences.",['Ten physically-fit divers (age: 25±4; 5 females; 67±113 open-water dives) performed'],"['incremental underwater fin-swimming until exhaustion at 4\u2009m water depth with either normal air or oxygen-enriched air', 'Oxygen-enriched Air Decreases Ventilation']","['Heart rate and ventilation', 'Heart rate, lactate, and time to exhaustion', 'factor breathing gas']","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0403082', 'cui_str': 'Diver'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0012823', 'cui_str': 'Diving'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0017110', 'cui_str': 'Gas'}]",10.0,0.031615,"Heart rate, lactate, and time to exhaustion showed no significant differences.","[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Möller', 'Affiliation': 'Department of Exercise Physiology, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Jacobi', 'Affiliation': 'Department of Exercise Physiology, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Exercise Physiology, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Muth', 'Affiliation': 'Occupational, Social, Environmental Medicine, Heinrich-Heine-Universitat Dusseldorf, Dusseldorf, Germany.'}, {'ForeName': 'Jochen D', 'Initials': 'JD', 'LastName': 'Schipke', 'Affiliation': 'Research Group Experimenal Surgery, University Hospital Düsseldorf, Dusseldorf, Germany.'}]",International journal of sports medicine,['10.1055/a-1554-5093']
1621,34410195,Communicating With Diverse Patients About Participating in a Biobank: A Randomized Multisite Study Comparing Electronic and Face-to-Face Informed Consent Processes.,"Some individuals' understanding of informed consent (IC) information may improve with electronic delivery, but others may benefit from face-to-face (F2F). This randomized, multisite study explores how individuals from diverse backgrounds understand electronic IC documents versus F2F, their confidence in understanding, and enrollment in research. A total of 501 patients at two U.S. biobanks with diverse populations participated. There were no overall differences between electronic and F2F understanding, but F2F predicted higher confidence in understanding and enrollment. Ethnicity and a higher educational level predicted higher understanding and confidence. Study findings suggest that electronic consent may lead to better understanding for non-Hispanic patients of higher socioeconomic status. F2F processes may lead to better understanding and higher enrollment of patients from Hispanic and lower socioeconomic levels. Researchers should carefully consider how they implement electronic IC processes and whether to maintain an F2F process to better address the needs and limitations of some populations.",2022,"There were no overall differences between electronic and F2F understanding, but F2F predicted higher confidence in understanding and enrollment.",['501 patients at two U.S. biobanks with diverse populations participated'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],[],501.0,0.146347,"There were no overall differences between electronic and F2F understanding, but F2F predicted higher confidence in understanding and enrollment.","[{'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Simon', 'Affiliation': '3065Duke University, Durham, NC, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': '4083University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Shinkunas', 'Affiliation': '4083University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Stein', 'Affiliation': '2006Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Meissner', 'Affiliation': '2006Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': '12244Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Pentz', 'Affiliation': 'School of Medicine, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Klein', 'Affiliation': '4083University of Iowa, Iowa City, IA, USA.'}]",Journal of empirical research on human research ethics : JERHRE,['10.1177/15562646211038819']
1622,34415011,BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences.,"BACKGROUND


State-of-the-art behavioral weight loss treatment (SBT) can lead to clinically meaningful weight loss, but only 30-60% achieve this goal. Developing adaptive interventions that change based on individual progress could increase the number of people who benefit.
PURPOSE


Conduct a Sequential Multiple Assignment Randomized Trial (SMART) to determine the optimal time to identify SBT suboptimal responders and whether it is better to switch to portion-controlled meals (PCM) or acceptance-based treatment (ABT).
METHOD


The BestFIT trial enrolled 468 adults with obesity who started SBT and were randomized to treatment response assessment at Session 3 (Early TRA) or 7 (Late TRA). Suboptimal responders were re-randomized to PCM or ABT. Responders continued SBT. Primary outcomes were weight change at 6 and 18 months.
RESULTS


PCM participants lost more weight at 6 months (-18.4 lbs, 95% CI -20.5, -16.2) than ABT participants (-15.7 lbs, 95% CI: -18.0, -13.4), but this difference was not statistically significant (-2.7 lbs, 95% CI: -5.8, 0.5, p = .09). PCM and ABT participant 18 month weight loss did not differ. Early and Late TRA participants had similar weight losses (p = .96), however, Early TRA PCM participants lost more weight than Late TRA PCM participants (p = .03).
CONCLUSIONS


Results suggest adaptive intervention sequences that warrant further research (e.g., identify suboptimal responders at Session 3, use PCMs as second-stage treatment). Utilizing the SMART methodology to develop an adaptive weight loss intervention that would outperform gold standard SBT in a randomized controlled trial is an important next step, but may require additional optimization work.
CLINICAL TRIAL INFORMATION


ClinicalTrials.gov identifier; NCT02368002.",2022,"Early and Late TRA participants had similar weight losses (p = .96), however, Early TRA PCM participants lost more weight than Late TRA PCM participants (p = .03).
",['468 adults with obesity who started SBT and were randomized to'],['treatment response assessment at Session 3 (Early TRA) or 7 (Late TRA'],"['weight', 'weight change', 'weight losses']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",468.0,0.29552,"Early and Late TRA participants had similar weight losses (p = .96), however, Early TRA PCM participants lost more weight than Late TRA PCM participants (p = .03).
","[{'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Sherwood', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'A Lauren', 'Initials': 'AL', 'LastName': 'Crain', 'Affiliation': 'HealthPartners Institute, Bloomington, MN, USA.'}, {'ForeName': 'Elisabeth M', 'Initials': 'EM', 'LastName': 'Seburg', 'Affiliation': 'HealthPartners Institute, Bloomington, MN, USA.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Crane', 'Affiliation': 'Department of Preventive Medicine, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Rona L', 'Initials': 'RL', 'LastName': 'Levy', 'Affiliation': 'School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Alicia S', 'Initials': 'AS', 'LastName': 'Kunin-Batson', 'Affiliation': 'Department of Pediatrics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Jeffery', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaab061']
1623,34414685,Combination of body mass index and albumin predicts the survival in metastatic castration-resistant prostate cancer patients treated with abiraterone: A post hoc analysis of two randomized trials.,"BACKGROUND


Low body mass index (BMI) and low serum albumin levels are suggested indicators of malnutrition and are associated with poor outcomes in cancer patients. Decreasing androgen can alter lipid metabolism, so the prognostic value of BMI may change in metastatic castration-resistant prostate cancer (mCRPC) patients receiving abiraterone. We aimed to delineate the prognostic value of BMI, serum albumin, and BMI and serum albumin (ALB) combined.
MATERIALS AND METHODS


A post hoc analysis was performed on data from two randomized clinical trials evaluating the efficacy of abiraterone in chemotherapy-pretreated and -naïve mCRPC patients. Survival analysis was conducted using Kaplan-Meier and Cox proportional hazard methods.
RESULTS


A total of 2,205 mCRPC patients were included in this study. Low ALB independently predicted the OS in both cohorts (HR, 1.54; 95%CI, 1.34-1.78 and HR, 1.40; 95%CI, 1.21-1.64, respectively), while low BMI independently predicted the OS only in the post-chemotherapy cohort (HR, 1.30; 95%CI, 1.12-1.50) but not in the pre-chemotherapy cohort (HR, 1.19; 95%CI, 0.98-1.43). By combining BMI (<25 kg/m 2  or ≥30 kg/m 2  ) and ALB (<4 g/dl or >4 g/dl), the four groups were characterized and their HRs were 1, 0.60 (95%CI, 0.47-0.76, p < 0.001), 0.75 (95%CI,0.61-0.92 p = 0.006), and 0.49 (95%CI, 0.41-0.60, p < 0.001) in post-chemotherapy patients and 1, 0.64 (95%CI, 0.46-0.89, p = 0.008), 0.75 (95%CI,0.58-0.98 p = 0.034), and 0.55 (95%CI, 0.42-0.72, p < 0.001) in chemotherapy-naïve patients, respectively.
CONCLUSIONS


Our results demonstrate that the combination of BMI and ALB better characterizes the risk groups irrespective of previous chemotherapy. Patients with high BMI but low ALB have higher risk of death than patients with low BMI but high ALB.",2021,"Low ALB independently predicted the OS in both cohorts (HR, 1.54; 95%CI, 1.34-1.78 and HR, 1.40; 95%CI, 1.21-1.64, respectively), while low BMI independently predicted the OS only in the post-chemotherapy cohort (HR, 1.30; 95%CI, 1.12-1.50) but not in the pre-chemotherapy cohort (HR, 1.19; 95%CI, 0.98-1.43).","['metastatic castration-resistant prostate cancer patients treated with', '2,205\xa0mCRPC patients', 'chemotherapy-pretreated and -naïve mCRPC patients', 'cancer patients', 'metastatic castration-resistant prostate cancer (mCRPC) patients receiving']",['abiraterone'],"['risk of death', 'prognostic value of BMI, serum albumin, and BMI and serum albumin (ALB) combined']","[{'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0754011', 'cui_str': 'abiraterone'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]",,0.285174,"Low ALB independently predicted the OS in both cohorts (HR, 1.54; 95%CI, 1.34-1.78 and HR, 1.40; 95%CI, 1.21-1.64, respectively), while low BMI independently predicted the OS only in the post-chemotherapy cohort (HR, 1.30; 95%CI, 1.12-1.50) but not in the pre-chemotherapy cohort (HR, 1.19; 95%CI, 0.98-1.43).","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Tingwei', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': 'Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",Cancer medicine,['10.1002/cam4.4205']
1624,34953469,Microbiological and Clinical Effects of a Proanthocyanidin-enriched Extract from Rumex acetosa in Periodontally Healthy Carriers of Porphyromonas gingivalis: a Randomized Controlled Pilot Study.,"Rumex acetosa  significantly inhibits the adhesion of  Porphyromonas gingivalis  ( P. g. ) to eukaryotic host cells  in vitro . The objective of this randomized placebo-controlled pilot-trial was to analyze effects of a mouth rinse containing 0.8% (w/w) of a quantified proanthocyanidin-enriched extract from  Rumex acetosa  (RA1) on microbiological, clinical, and cytological parameters in systemically healthy individuals without history of periodontitis, harboring  P. g.  intraorally. 35 subjects received a supragingival debridement (SD) followed by mouth rinsing (3 times daily) with either RA1 mouth rinse solution (test) or placebo (control) for 7 days as adjunct to routine oral hygiene. Supragingival biofilm samples were taken at screening visit, baseline (BL), 2, 4, 7 and 14 days after SD.  P. g.  and 11 other oral microorganisms were detected and quantified by rtPCR. Changes in the oral microbiota composition of one test and one control subject were assessed via high throughput 16S rRNS gene amplicon sequencing. Approximal Plaque Index (API) and the modified Sulcular Bleeding Index (SBI) were assessed at BL, 7- and 14-days following SD. Brush biopsies were taken at BL and 14 d following SD. Intergroup comparisons revealed no significant microbiological, cytological, and clinical differences at any timepoint. However, a significant reduction in SBI at day 14 ( p  = 0.003) and API at day 7 ( p  = 0.02) and day 14 ( p  = 0.009) was found in the test group by intragroup comparison. No severe adverse events were observed. The results indicate that RA1 mouth rinse is safe but does not seem to inhibit colonization of  P. g.  or improve periodontal health following SD.",2021,Rumex acetosa significantly inhibits the adhesion of Porphyromonas gingivalis (P.g.) to eukaryotic host cells in vitro.,"['systemically healthy individuals without history of periodontitis, harboring P.g', '35 subjects received a', 'periodontally healthy carriers of Porphyromonas gingivalis']","['Proanthocyanidin-enriched extract', 'placebo', 'mouth rinse containing 0.8 % (w/w) of a quantified proanthocyanidin-enriched extract from Rumex acetosa (RA1', 'RA1 mouth rinse solution (test) or placebo (control', 'supragingival debridement (SD) followed by mouth rinsing']","['SBI', 'periodontal health', 'API', 'severe adverse events', 'Approximal Plaque Index (API) and the modified Sulcular Bleeding Index (SBI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}]","[{'cui': 'C0072018', 'cui_str': 'Proanthocyanidin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0330387', 'cui_str': 'Rumex acetosa'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",35.0,0.0789418,Rumex acetosa significantly inhibits the adhesion of Porphyromonas gingivalis (P.g.) to eukaryotic host cells in vitro.,"[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Selbach', 'Affiliation': 'Adelaide Dental School, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Klocke', 'Affiliation': 'Private Practice, Krefeld, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Peters', 'Affiliation': 'Department of Periodontics, Preventive and Restorative Dentistry, University Medical Center Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Beckert', 'Affiliation': 'Institute of Pharmaceutical Biology and Phytochemistry, University of Münster, Münster, Germany.'}, {'ForeName': 'Rory Munro', 'Initials': 'RM', 'LastName': 'Watt', 'Affiliation': ""Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, Peoples' Republic of China.""}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Tong', 'Affiliation': ""Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, Peoples' Republic of China.""}, {'ForeName': 'Thomas Frank', 'Initials': 'TF', 'LastName': 'Flemmig', 'Affiliation': ""Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, Peoples' Republic of China.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hensel', 'Affiliation': 'Institute of Pharmaceutical Biology and Phytochemistry, University of Münster, Münster, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Beikler', 'Affiliation': 'Department of Periodontics, Preventive and Restorative Dentistry, University Medical Center Eppendorf, Hamburg, Germany.'}]",Planta medica,['10.1055/a-1728-2249']
1625,34974019,"Reducing indoor relative humidity can improve the circulation and cardiorespiratory health of older people in a cold environment: A field trial conducted in Chongqing, China.","The changing climate is one of the most important factors affecting public health. Older people are particularly threatened due to their less efficient immune systems. To evaluate the potential benefits of short-term indoor dehumidification on their circulation and cardiopulmonary health, we conducted a random, cross-over experiment with 36 healthy residents of an aged-care center in Chongqing, China in 2020. Vapor compression dehumidifiers were used over two 48-h periods. At the end of each 48 h, we immediately measured sixteen circulatory system biomarkers of inflammation, coagulation, and oxidative stress; lung function; blood pressure; and heart rate. Indoor temperature and relative humidity were monitored throughout the study period. Linear, mixed-effect models were used to associate health endpoints with indoor relative humidity. This intervention study showed that when the indoor relative humidity decreased from 75% to 45%: (1) the coagulation indicators, sCD40l, and PAI-1, decreased significantly, by 58.82% and 23.50%, respectively; (2) the inflammatory indicators, CRP, IL-6, and TNF-α decreased significantly, by 4.09%, 25.78%, and 10.60%, respectively; (3) PEF, FEV 1  and FVC were increased significantly by 20.08%, 14.54%, and 15.75% respectively. To the best of our knowledge, this is the first study to examine the impact of short-term dehumidification on clinical and biochemical measures of cardiorespiratory health in humid areas, and our study suggests that RH in the dehumidified rooms (46.9 ± 8.7%) may be healthier than that in humid rooms (75.2 ± 7.9%). Humidity may be involved in the development of atherosclerosis by activating oxidative stress and mediating the secretion of inflammatory indicators. At the same time, platelet activation induced by oxidative stress stimulates thrombosis to increase cardiovascular risk in older people. Conclusion: This intervention study shows that in a Chinese city like Chongqing with serious indoor environmental humidity, indoor short-term dehumidification has obvious cardiopulmonary benefits for the healthy elderly.",2022,"At the end of each 48 h, we immediately measured sixteen circulatory system biomarkers of inflammation, coagulation, and oxidative stress; lung function; blood pressure; and heart rate.","['Older people', 'older people in a cold environment', 'healthy elderly', '36 healthy residents of an aged-care center in Chongqing, China in 2020']",['short-term indoor dehumidification'],"['inflammatory indicators, CRP, IL-6, and TNF-α', 'sixteen circulatory system biomarkers of inflammation, coagulation, and oxidative stress; lung function; blood pressure; and heart rate', 'PEF, FEV 1  and FVC', 'indoor relative humidity', 'coagulation indicators, sCD40l, and PAI-1', 'Indoor temperature and relative humidity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0241842', 'cui_str': 'Cold environment'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030771', 'cui_str': 'Pefloxacin'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0428696', 'cui_str': 'Relative humidity'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",,0.0507769,"At the end of each 48 h, we immediately measured sixteen circulatory system biomarkers of inflammation, coagulation, and oxidative stress; lung function; blood pressure; and heart rate.","[{'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'Joint International Research Laboratory of Green Buildings and Built Environments, Ministry of Education, Chongqing University, Chongqing 400045, China; National Centre for International Research of Low-carbon and Green Buildings, Ministry of Science and Technology, Chongqing University, Chongqing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Department of Geriatrics, Chongqing University Central Hospital, Chongqing Emergency Medical Center, Chongqing 400014, China.'}, {'ForeName': 'Baizhan', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Joint International Research Laboratory of Green Buildings and Built Environments, Ministry of Education, Chongqing University, Chongqing 400045, China; National Centre for International Research of Low-carbon and Green Buildings, Ministry of Science and Technology, Chongqing University, Chongqing, China.'}, {'ForeName': 'Chenqiu', 'Initials': 'C', 'LastName': 'Du', 'Affiliation': 'Joint International Research Laboratory of Green Buildings and Built Environments, Ministry of Education, Chongqing University, Chongqing 400045, China; National Centre for International Research of Low-carbon and Green Buildings, Ministry of Science and Technology, Chongqing University, Chongqing, China.'}, {'ForeName': 'Runming', 'Initials': 'R', 'LastName': 'Yao', 'Affiliation': 'Joint International Research Laboratory of Green Buildings and Built Environments, Ministry of Education, Chongqing University, Chongqing 400045, China; National Centre for International Research of Low-carbon and Green Buildings, Ministry of Science and Technology, Chongqing University, Chongqing, China.'}, {'ForeName': 'Lexiang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Joint International Research Laboratory of Green Buildings and Built Environments, Ministry of Education, Chongqing University, Chongqing 400045, China; National Centre for International Research of Low-carbon and Green Buildings, Ministry of Science and Technology, Chongqing University, Chongqing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Lab of Environmental Biomedicine, School of Life Sciences, Central China Normal University, Wuhan 430079, China; Joint International Research Laboratory of Green Buildings and Built Environments, Ministry of Education, Chongqing University, Chongqing 400045, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Joint International Research Laboratory of Green Buildings and Built Environments, Ministry of Education, Chongqing University, Chongqing 400045, China; National Centre for International Research of Low-carbon and Green Buildings, Ministry of Science and Technology, Chongqing University, Chongqing, China. Electronic address: yuweicqu@cqu.edu.cn.'}]",The Science of the total environment,['10.1016/j.scitotenv.2021.152695']
1626,34974435,One-Year Follow-Up of Healthy Older Adults with Electroencephalographic Risk for Neurocognitive Disorder After Neurofeedback Training.,"BACKGROUND


In healthy older adults, excess theta activity is an electroencephalographic (EEG) predictor of cognitive impairment. In a previous study, neurofeedback (NFB) treatment reinforcing reductions theta activity resulted in EEG reorganization and cognitive improvement.
OBJECTIVE


To explore the clinical applicability of this NFB treatment, the present study performed a 1-year follow-up to determine its lasting effects.
METHODS


Twenty seniors with excessive theta activity in their EEG were randomly assigned to the experimental or control group. The experimental group received an auditory reward when the theta absolute power (AP) was reduced. The control group received the reward randomly.
RESULTS


Both groups showed a significant decrease in theta activity at the training electrode. However, the EEG results showed that only the experimental group underwent global changes after treatment. These changes consisted of delta and theta decreases and beta increases. Although no changes were found in any group during the period between the posttreatment evaluation and follow-up, more pronounced theta decreases and beta increases were observed in the experimental group when the follow-up and pretreatment measures were compared. Executive functions showed a tendency to improve two months after treatment which became significant one year later.
CONCLUSION


These results suggest that the EEG and behavioral benefits of this NFB treatment persist for at least one year, which adds up to the available evidence contributing to identifying factors that increase its efficacy level. The relevance of this study lies in its prophylactic features of addressing a clinically healthy population with EEG risk of cognitive decline.",2022,"Although no changes were found in any group during the period between the posttreatment evaluation and follow-up, more pronounced theta decreases and beta increases were observed in the experimental group when the follow-up and pretreatment measures were compared.","['clinically healthy population with EEG risk of cognitive decline', 'Healthy Older Adults with Electroencephalographic Risk for Neurocognitive Disorder', 'Twenty seniors with excessive theta activity in their EEG', 'healthy older adults']",[],"['EEG reorganization and cognitive improvement', 'theta activity', 'Executive functions']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",[],"[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",20.0,0.0108309,"Although no changes were found in any group during the period between the posttreatment evaluation and follow-up, more pronounced theta decreases and beta increases were observed in the experimental group when the follow-up and pretreatment measures were compared.","[{'ForeName': 'Graciela C', 'Initials': 'GC', 'LastName': 'Alatorre-Cruz', 'Affiliation': 'Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de México, Estado de México, México.'}, {'ForeName': 'Thalía', 'Initials': 'T', 'LastName': 'Fernández', 'Affiliation': 'Departamento de Neurobiología Conductual y Cognitiva, Instituto de Neurobiología, Universidad Nacional Autónoma de México, Querétaro, México.'}, {'ForeName': 'Susana A', 'Initials': 'SA', 'LastName': 'Castro-Chavira', 'Affiliation': 'Departamento de Neurobiología Conductual y Cognitiva, Instituto de Neurobiología, Universidad Nacional Autónoma de México, Querétaro, México.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'González-López', 'Affiliation': 'Departamento de Neurobiología Conductual y Cognitiva, Instituto de Neurobiología, Universidad Nacional Autónoma de México, Querétaro, México.'}, {'ForeName': 'Sergio M', 'Initials': 'SM', 'LastName': 'Sánchez-Moguel', 'Affiliation': 'Departamento de Neurobiología Conductual y Cognitiva, Instituto de Neurobiología, Universidad Nacional Autónoma de México, Querétaro, México.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Silva-Pereyra', 'Affiliation': 'Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de México, Estado de México, México.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-215538']
1627,34871153,Review of efficacy of ciclesonide for the treatment of asthma in children.,"Background:  Ciclesonide (CIC) is an inhaled corticosteroid (ICS) approved for the maintenance treatment of asthma in patients ages ≥ 12 years. The prodrug aspect of CIC is associated with a safety profile that may make it ideal for children.  Objective:  The objective was to summarize efficacy results from the eight phase III, randomized, double-blind, controlled trials in children with asthma conducted during CIC clinical development.  Methods:  Four trials compared CIC 40, 80, or 160 µg/day with placebo. Two trials compared CIC 160 µg/day with fluticasone propionate 200 µg/day, one trial compared CIC 80 or 160 µg/day with fluticasone 200 µg/day, and one trial compared CIC 160 µg/day with budesonide 400 µg/day.  Results:  The primary end point was met by at least two CIC doses versus placebo in the trials in which the primary end point was the change from baseline in lung function outcome (forced expiratory volume in 1 second [FEV 1 ] % predicted or morning peak expiratory flow [PEF]). A trial that compared CIC with placebo did not meet the primary end point of superiority in time-to-first severe wheeze exacerbation or lack of improvement. The primary end point of noninferiority to the active control (fluticasone or budesonide) in the change from baseline in a lung function outcome (FEV 1 , morning PEF, evening PEF) was met with the CIC 160-µg dose in all active control trials. CIC generally demonstrated statistically significant improvements in forced expiratory flow at 25%-75% of forced vital capacity, asthma symptoms, rescue medication use, and asthma control when compared with placebo and noninferiority for these outcomes compared with fluticasone or budesonide.  Conclusion:  In children with asthma, once-daily CIC significantly improved large and small airway function, asthma symptoms, and asthma control, and reduced rescue medication use compared with placebo. CIC was comparable with other ICS used to treat asthma in children, which demonstrated its worth for the pediatric population.",2021,"CIC generally demonstrated statistically significant improvements in forced expiratory flow at 25%-75% of forced vital capacity, asthma symptoms, rescue medication use, and asthma control when compared with placebo and noninferiority for these outcomes compared with fluticasone or budesonide.  ","['asthma in children', 'asthma in patients ages ≥ 12 years', 'children with asthma conducted during CIC clinical development']","['placebo', 'ciclesonide', 'fluticasone propionate', 'budesonide', 'fluticasone', 'Ciclesonide (CIC', 'active control (fluticasone or budesonide', 'CIC', 'ICS', 'corticosteroid (ICS']","['large and small airway function, asthma symptoms, and asthma control', 'lung function outcome (FEV 1 , morning PEF, evening PEF', 'forced vital capacity, asthma symptoms, rescue medication use, and asthma control', 'lung function outcome (forced expiratory volume', 'morning peak expiratory flow [PEF', 'forced expiratory flow']","[{'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0055670', 'cui_str': 'CHVP protocol'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0907850', 'cui_str': 'ciclesonide'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0055670', 'cui_str': 'CHVP protocol'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0030771', 'cui_str': 'Pefloxacin'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}]",,0.690699,"CIC generally demonstrated statistically significant improvements in forced expiratory flow at 25%-75% of forced vital capacity, asthma symptoms, rescue medication use, and asthma control when compared with placebo and noninferiority for these outcomes compared with fluticasone or budesonide.  ","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Blaiss', 'Affiliation': 'From the Department of Pediatrics, Medical College of Georgia at Augusta University, Augusta Georgia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Berger', 'Affiliation': 'Allergy and Asthma Associates of Southern California, Mission Viejo, California.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Chipps', 'Affiliation': 'Capital Allergy and Respiratory Disease Center, Sacramento, California.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Hernandez-Trujillo', 'Affiliation': 'Department of Pediatrics, Herbert Wertheim School of Medicine, Florida International University, Miami, Florida.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Division of Immunology and Allergy, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts; and.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Steward', 'Affiliation': 'Covis Pharma B.V., Zug, Switzerland.'}]",Allergy and asthma proceedings,['10.2500/aap.2021.42.210062']
1628,34982098,Comparison of Drug-Eluting Stent With Bare-Metal Stent in Patients With Symptomatic High-grade Intracranial Atherosclerotic Stenosis: A Randomized Clinical Trial.,"Importance


In-stent restenosis (ISR) is the primary reason for stroke recurrence after intracranial stenting in patients who were treated with a standard bare-metal stent (BMS). Whether a drug-eluting stent (DES) could reduce the risk of ISR in intracranial atherosclerotic stenosis (ICAS) remains unclear.
Objective


To investigate whether a DES can reduce the risk of ISR and stroke recurrence in patients with symptomatic high-grade ICAS.
Design, Settings, and Participants


A prospective, multicenter, open-label randomized clinical trial with blinded outcome assessment was conducted from April 27, 2015, to November 16, 2018, at 16 medical centers in China with a high volume of intracranial stenting. Patients with symptomatic high-grade ICAS were enrolled, randomized, and followed up for 1 year. Intention-to-treat data analysis was performed from April 1 to May 22, 2021.
Interventions


Patients were randomly assigned to receive DES (NOVA intracranial sirolimus-eluting stent system) or BMS (Apollo intracranial stent system) treatment in a 1:1 ratio.
Main Outcomes and Measures


The primary efficacy end point was ISR within 1 year after the procedure, which was defined as stenosis that was greater than 50% of the luminal diameter within or immediately adjacent to (within 5 mm) the implanted stent. The primary safety end point was any stroke or death within 30 days after the procedure.
Results


A total of 263 participants (194 men [73.8%]; median [IQR] age, 58 [52-65] years) were included in the analysis, with 132 participants randomly assigned to the DES group and 131 to the BMS group. The 1-year ISR rate was lower in the DES group than in the BMS group (10 [9.5%] vs 32 [30.2%]; odds ratio, 0.24; 95% CI, 0.11-0.52; P < .001). The DES group also had a significantly lower ischemic stroke recurrence rate from day 31 to 1 year (1 [0.8%] vs 9 [6.9%]; hazard ratio, 0.10; 95% CI, 0.01-0.80; P = .03). No significant difference in the rate of any stroke or death within 30 days was observed between the DES and BMS groups (10 [7.6%] vs 7 [5.3%]; odds ratio, 1.45; 95% CI, 0.54-3.94; P = .46).
Conclusions and Relevance


This trial found that, compared with BMSs, DESs reduced the risks of ISR and ischemic stroke recurrence in patients with symptomatic high-grade ICAS. Further investigation into the safety and efficacy of DESs is warranted.
Trial Registration


ClinicalTrials.gov Identifier: NCT02578069.",2022,"No significant difference in the rate of any stroke or death within 30 days was observed between the DES and BMS groups (10 [7.6%] vs 7 [5.3%]; odds ratio, 1.45; 95% CI, 0.54-3.94; P = .46).
","['patients who were treated with a standard bare-metal stent (BMS', 'April 27, 2015, to November 16, 2018, at 16 medical centers in China with a high volume of intracranial stenting', 'Patients With Symptomatic High-grade Intracranial Atherosclerotic Stenosis', 'patients with symptomatic high-grade ICAS', 'Patients with symptomatic high-grade ICAS', 'A total of 263 participants (194 men [73.8%]; median [IQR] age, 58 [52-65] years) were included in the analysis, with 132 participants randomly assigned to the DES group and 131 to the BMS group']","['DES', 'BMSs, DESs', 'DES (NOVA intracranial sirolimus-eluting stent system) or BMS (Apollo intracranial stent system', 'Drug-Eluting Stent With Bare-Metal Stent', 'stent restenosis (ISR', 'BMS', 'drug-eluting stent (DES']","['risks of ISR and ischemic stroke recurrence', '1-year ISR rate', 'stroke or death', 'rate of any stroke or death', 'risk of ISR and stroke recurrence', 'ischemic stroke recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",263.0,0.330986,"No significant difference in the rate of any stroke or death within 30 days was observed between the DES and BMS groups (10 [7.6%] vs 7 [5.3%]; odds ratio, 1.45; 95% CI, 0.54-3.94; P = .46).
","[{'ForeName': 'Baixue', 'Initials': 'B', 'LastName': 'Jia', 'Affiliation': 'Interventional Neuroradiology Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xuelei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Stroke Center, Beijing Institute of Brain Disorders, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Ma', 'Affiliation': 'Interventional Neuroradiology Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dapeng', 'Initials': 'D', 'LastName': 'Mo', 'Affiliation': 'Interventional Neuroradiology Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Interventional Neuroradiology Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Interventional Neuroradiology Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Interventional Neuroradiology Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Interventional Neuroradiology Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Interventional Neuroradiology Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Interventional Neuroradiology Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Zengpin', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Guan', 'Affiliation': 'Neurointerventional Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Cerebrovascular Disease, Hainan General Hospital, Haikou, Hainan, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Yantai Yuhuangding Hospital, Yantai, Shandong, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Neurology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xinfeng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Shenzhen Hospital of Southern Medical University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Kangning', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, The Southwest Hospital of Army Medical University, Chongqing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shuai', 'Affiliation': 'Department of Neurology, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Jieqing', 'Initials': 'J', 'LastName': 'Wan', 'Affiliation': 'Department of Neurosurgery, Renji Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Xiangqun', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Neurology, General Hospital of Lanzhou Military Command, Lanzhou, China.'}, {'ForeName': 'Tianxiao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Neurointerventional Department, Henan Provincial People's Hospital, Zhengzhou University, Zhengzhou, Henan, China.""}, {'ForeName': 'Binge', 'Initials': 'B', 'LastName': 'Chang', 'Affiliation': 'Department of Neurosurgery, Tianjin First Central Hospital, Tianjin, China.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Liebeskind', 'Affiliation': 'Department of Neurology, UCLA (University of California, Los Angeles).'}, {'ForeName': 'Wengui', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, University of California, Irvine, Irvine.'}, {'ForeName': 'Zhongrong', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Interventional Neuroradiology Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2021.4804']
1629,34916313,Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: study protocol of a randomised controlled non-inferiority trial.,"BACKGROUND


Around 15%-20% of children with acute otitis media present with ear discharge due to a spontaneous tear or perforation of the eardrum (AOMd). Current guidance recommends clinicians to consider oral antibiotics as first-line treatment in this condition. The opening in the eardrum however should allow topical antibiotics to enter the middle ear directly. Local administration of antibiotics does not expose children to systemic side effects and may put less selective resistance pressure on bacteria. Evidence on the effectiveness of this approach in children with AOMd is lacking.
METHODS AND ANALYSIS


A primary care-based, open, individually randomised, controlled, non-inferiority trial. The trial aims to recruit 350 children aged 6 months to 12 years with AOMd and ear pain and/or fever. Participants will be randomised to 7 days of hydrocortisone-bacitracin-colistin eardrops five drops three times daily or amoxicillin oral suspension 50 mg/kg body weight per day, divided over three doses. Parents will keep a daily diary of AOM symptoms, adverse events and complications for 2 weeks. In addition, they will record AOM recurrences, healthcare utilisation and societal costs for 3 months. The primary outcome is the proportion of children without ear pain and fever at day 3. Secondary outcomes include ear pain and fever intensity/severity; days with ear discharge; eardrum perforation at 2 weeks; adverse events during first 2 weeks; costs; and cost effectiveness at 2 weeks and 3 months. The primary analyses will be intention-to-treat and per-protocol analyses will be conducted as well.
ETHICS AND DISSEMINATION


The medical research ethics committee Utrecht, The Netherlands has given ethical approval (17-400/G-M). Parents/guardians of participants will provide written informed consent. Study results will be submitted for publication in peer-reviewed medical journals and presented at relevant (inter)national scientific meetings.
TRIAL REGISTRATION NUMBER


The Netherlands National Trial Register; NTR6723. Date of registration: 27 November 2017.",2021,Secondary outcomes include ear pain and fever intensity/severity; days with ear discharge; eardrum perforation at 2 weeks; adverse events during first 2 weeks; costs; and cost effectiveness at 2 weeks and 3 months.,"['children with AOMd is lacking', 'children with acute otitis media present with ear discharge due to a spontaneous tear or perforation of the eardrum (AOMd', '350 children aged 6 months to 12 years with AOMd and ear pain and/or fever', 'children with acute otitis media presenting with ear discharge']","['antibiotics', 'Topical or oral antibiotics', 'amoxicillin oral suspension', 'hydrocortisone-bacitracin-colistin eardrops']","['proportion of children without ear pain and fever at day 3', 'AOM recurrences, healthcare utilisation and societal costs', 'ear pain and fever intensity/severity; days with ear discharge; eardrum perforation at 2 weeks; adverse events during first 2 weeks; costs; and cost effectiveness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0271429', 'cui_str': 'Acute otitis media'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0155540', 'cui_str': 'Ear discharge'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0041445', 'cui_str': 'Tympanic membrane structure'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013456', 'cui_str': 'Otalgia'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0308457', 'cui_str': 'Amoxicillin Oral Suspension [Biomox]'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}]","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0013456', 'cui_str': 'Otalgia'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004519', 'cui_str': 'Azoxymethane'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0155540', 'cui_str': 'Ear discharge'}, {'cui': 'C0206504', 'cui_str': 'Perforation of tympanic membrane'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",350.0,0.277032,Secondary outcomes include ear pain and fever intensity/severity; days with ear discharge; eardrum perforation at 2 weeks; adverse events during first 2 weeks; costs; and cost effectiveness at 2 weeks and 3 months.,"[{'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Hullegie', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands s.hullegie@umcutrecht.nl.'}, {'ForeName': 'Roderick P', 'Initials': 'RP', 'LastName': 'Venekamp', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Thijs M A', 'Initials': 'TMA', 'LastName': 'van Dongen', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Mulder', 'Affiliation': 'Parent and PPI contributor, Utrecht, the Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'van Schaik', 'Affiliation': 'Institute of Microbiology and Infection, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'G Ardine', 'Initials': 'GA', 'LastName': 'de Wit', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Alastair D', 'Initials': 'AD', 'LastName': 'Hay', 'Affiliation': 'Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care Population Science and Medical Education, Aldemoor Health Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Moore', 'Affiliation': 'Primary Care Population Science and Medical Education, Aldemoor Health Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'Elisabeth A M', 'Initials': 'EAM', 'LastName': 'Sanders', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.""}, {'ForeName': 'Marc J M', 'Initials': 'MJM', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Debby', 'Initials': 'D', 'LastName': 'Bogaert', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.""}, {'ForeName': 'Anne Gm', 'Initials': 'AG', 'LastName': 'Schilder', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Roger A M J', 'Initials': 'RAMJ', 'LastName': 'Damoiseaux', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2021-052128']
1630,34959168,Safety and efficacy of dendritic cell-based immunotherapy (DCVAC/LuCa) combined with carboplatin/pemetrexed for patients with advanced non-squamous non-small-cell lung cancer without oncogenic drivers.,"BACKGROUND


Our prospective, open-label, single-arm phase II study investigated the safety and efficacy of DCVAC/LuCa (dendritic cell vaccines for lung cancer) combined with standard carboplatin/pemetrexed in advanced non-squamous (nsq) non-small-cell lung cancer (NSCLC).
PATIENTS AND METHODS


Eligible patients had stage IV nsq NSCLC without oncogenic drivers and had not received prior systemic cancer therapy. Treatment consisted of carboplatin/pemetrexed for up to 6 cycles followed by 21 cycles of pemetrexed maintenance or until progression or intolerance. Non-progression patients after two cycles of chemotherapy started to receive DCVAC/LuCa subcutaneously (s.c.) on day 15 of cycle 3, and thereafter q3w (day 15 of chemotherapy cycles) for up to 15 doses. Dosing of DCVAC/LuCa s.c. varied among patients depending on the baseline number of leucocytes but remained constant for each single patient. Safety was assessed by adverse events (AEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs). Efficacy was measured by overall survival (OS), progression-free survival (PFS), time to progression (TTP), and objective response rate (ORR).
RESULTS


Sixty-one patients were enrolled. In the safety population (n = 60), eight patients (13.33%) had grade 3 or greater TRAEs, and six patients (10.0%) showed SAEs which were not related to leukapheresis or DC vaccination. Six grade 1 AEs were considered to be related to leukapheresis. No AESIs or DCVAC/LuCa-induced AEs were observed. The 2-year survival rate in the modified intention-to-treat population (n = 44) was 52.57%. Median OS was not reached. Median PFS was 8.0 months, median TTP was 10.2 months, and the ORR was 31.82%.
CONCLUSION


In treatment-naïve stage IV nsq NSCLC patients without oncogenic drivers, the combination of carboplatin/pemetrexed and DCVAC/LuCa was well tolerated and showed promising efficacy. Therefore, a study to prove our immunotherapeutic concept in a randomized phase III trial is planned.",2022,"In the safety population (n = 60), eight patients (13.33%) had grade 3 or greater TRAEs, and six patients (10.0%) showed SAEs which were not related to leukapheresis or DC vaccination.","['advanced non-squamous (nsq) non-small-cell lung cancer (NSCLC', 'patients with advanced non-squamous non-small-cell lung cancer without oncogenic drivers', 'Sixty-one patients were enrolled', 'Eligible patients had stage IV nsq NSCLC without oncogenic drivers and had not received prior systemic cancer therapy', 'lung cancer']","['dendritic cell-based immunotherapy (DCVAC/LuCa) combined with carboplatin/pemetrexed', 'standard carboplatin/pemetrexed', 'DCVAC/LuCa (dendritic cell vaccines', 'carboplatin/pemetrexed and DCVAC/LuCa', 'carboplatin/pemetrexed', 'DCVAC/LuCa']","['2-year survival rate', 'median TTP', 'Efficacy', 'No AESIs or DCVAC/LuCa-induced AEs', 'grade 3 or greater TRAEs', 'ORR', 'Median PFS', 'adverse events (AEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs', 'overall survival (OS), progression-free survival (PFS), time to progression (TTP), and objective response rate (ORR', 'Median OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0003315', 'cui_str': 'Immunologic Accessory Cells'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0073828', 'cui_str': 'S-1,2-dichlorovinyl-N-acetylcysteine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1963761', 'cui_str': 'No adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0073828', 'cui_str': 'S-1,2-dichlorovinyl-N-acetylcysteine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",61.0,0.366489,"In the safety population (n = 60), eight patients (13.33%) had grade 3 or greater TRAEs, and six patients (10.0%) showed SAEs which were not related to leukapheresis or DC vaccination.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zhong', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Ling', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China. Electronic address: 18930858216@163.com.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China. Electronic address: eddiedong8@hotmail.com.'}]",ESMO open,['10.1016/j.esmoop.2021.100334']
1631,34402024,"Neuroprotective Effect of Trans-Resveratrol in Mild to Moderate Alzheimer Disease: A Randomized, Double-Blind Trial.","INTRODUCTION


Amyloid-beta (Aβ) protein is a major component of the extracellular plaque found in the brains of individuals with Alzheimer's disease (AD). In this study, we investigated the effect of trans-resveratrol as an antagonist treatment for moderate to mild AD, as well as its safety and tolerability.
METHODS


This was a case-control study that enrolled 30 selected patients who had been clinically diagnosed with moderate to mild AD. These patients were randomly divided into two groups, namely, a placebo group (n = 15) and a trans-resveratrol group (n = 15) who received 500 mg trans-resveratrol orally once daily for 52 weeks. Brain magnetic resonance imaging (MRI) examinations were performed on and cerebrospinal fluid (CSF) samples were obtained from all participants before (baseline) and after the study (52 weeks). Enzyme-linked immunosorbent assays were used to determine the levels of plasma Aβ40 and Aβ42 and CSF Aβ40 and Aβ42.
RESULTS


The results showed that the changes over the study period in the levels of Aβ40 in the blood and CSF of the patients treated with trans-resveratrol were not statistically significant (P > 0.05). In contrast, patients who received placebo showed a significant decrease in Aβ40 levels compared with that at the beginning of the study (CSF Aβ40: P = 0.024, plasma Aβ40: P = 0.036). Analysis of the images on the brain MRI scans revealed that the brain volume of the patients treated with trans-resveratrol was significantly reduced at 52 weeks (P = 0.011) compared with that of patients in the placebo treatment group, Further analysis indicated that the level of matrix metallopeptidase 9 in the CSF of the patients treated with trans-resveratrol at 52 weeks decreased by 46% compared with that of patients in the placebo group (P = 0.033).
CONCLUSION


These results indicate that trans-resveratrol has potential neuroprotective roles in the treatment of moderate to mild AD and that its mechanism may involve a reduction in the accumulation and toxicity of Aβ in the brain of patients, thereby reducing neuroinflammation.
TRIAL REGISTRATION


Chinese clinical trial registry: CTR20151780X.",2021,Aβ) protein is a major component of the extracellular plaque found in the brains of individuals with Alzheimer's disease (AD).,"['Mild to Moderate Alzheimer Disease', ""individuals with Alzheimer's disease (AD"", 'enrolled 30 selected patients who had been clinically diagnosed with moderate to mild AD']","['Trans-Resveratrol', 'trans-resveratrol group (n\u2009=\u200915) who received 500\xa0mg trans-resveratrol orally once daily for 52\xa0weeks', 'trans-resveratrol', 'Brain magnetic resonance imaging (MRI) examinations', 'placebo']","['level of matrix metallopeptidase', 'Aβ40 levels', 'brain volume', 'levels of plasma Aβ40 and Aβ42 and CSF Aβ40 and Aβ42', 'levels of Aβ40 in the blood and CSF', 'safety and tolerability']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0025543', 'cui_str': 'Metalloproteinase'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",30.0,0.257796,Aβ) protein is a major component of the extracellular plaque found in the brains of individuals with Alzheimer's disease (AD).,"[{'ForeName': 'Jiachen', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Neurology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zongshan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yongang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yaxing', 'Initials': 'Y', 'LastName': 'Gui', 'Affiliation': 'Department of Neurology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. YaxingGui@shsmu.edu.cn.'}]",Neurology and therapy,['10.1007/s40120-021-00271-2']
1632,34403155,Use of plasma late on cardiopulmonary bypass in patients undergoing left ventricular assist device implantation.,"Coagulopathy is common during left ventricular assist device (LVAD) implantation, treatment of which can be challenging given the often-limited ability for the right ventricle to accommodate volume transfusion after device initiation with 20% to 40% of patients developing right ventricular failure (RVF). Transfusion of plasma late on cardiopulmonary bypass (CPB) combined with ultrafiltration may replace clotting factors while reducing volume administration. We compared outcomes in patients undergoing LVAD implantation receiving plasma on CPB and ultrafiltration with traditional transfusion practices. Co-primary outcomes needed for blood product transfusion in the first 6 and 24 hours after CPB. Secondary outcomes included metrics of morbidity and mortality. 396 patients were analyzed (59 plasma on CPB). Patients receiving plasma on CPB had a greater volume of blood products transfused (3764 vs. 2741 mL first 6 hours; 6059 vs. 4305 mL first 24 hours) in unadjusted analysis. In adjusted analysis, plasma transfusion on CPB with ultrafiltration had no significant effect on the primary outcomes of blood products given in the first 6 hours (estimated effect size 982 [-428, 2392] mL, P = .17) and 24 hours (estimated effect size 1076 [-904, 3057] mL, P = .29). Patients receiving plasma on CPB were more likely on either vasopressors or inotropes at 24 hours after ICU admission (P = .01), however, indices of coagulopathy and RVF were similar between groups. While prospective studies would be necessary to definitively evaluate the clinical utility of this strategy, no signal for benefit was observed suggesting plasma should not be used for this purpose.",2022,"In adjusted analysis, plasma transfusion on CPB with ultrafiltration had no significant effect on the primary outcomes of blood products given in the first 6 hours (estimated effect size 982 [-428,2392] ml, p = 0.17) and 24 hours (estimated effect size 1076 [-904, 3057] ml, p=0.29).","['396 patients were analyzed (59 plasma on CPB', 'patients undergoing LVAD implantation receiving plasma on CPB and ultrafiltration with traditional transfusion practices', 'Patients Undergoing LVAD Implant']",['cardiopulmonary bypass (CPB) combined with ultrafiltration'],"['metrics of morbidity and mortality', 'blood product transfusion', 'indices of coagulopathy and RVF', 'volume of blood products transfused', 'blood products']","[{'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}]","[{'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0235527', 'cui_str': 'Right heart failure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}]",396.0,0.0748731,"In adjusted analysis, plasma transfusion on CPB with ultrafiltration had no significant effect on the primary outcomes of blood products given in the first 6 hours (estimated effect size 982 [-428,2392] ml, p = 0.17) and 24 hours (estimated effect size 1076 [-904, 3057] ml, p=0.29).","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Nelson', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Diaz Soto', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Warner', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Stulak', 'Affiliation': 'Department of Cardiovascular Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Phillip J', 'Initials': 'PJ', 'LastName': 'Schulte', 'Affiliation': 'Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Weister', 'Affiliation': 'Anesthesia Information and Management Analytics - Anesthesia Clinical Research Unit, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Mauermann', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Smith', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA.'}]",Artificial organs,['10.1111/aor.14052']
1633,34405565,Effects of phosphodiesterase V inhibition alone and in combination with BNP on cardiovascular and renal response to volume load in human preclinical diastolic dysfunction.,"Preclinical diastolic dysfunction (PDD) results in impaired cardiorenal response to volume load (VL) which may contribute to the progression to clinical heart failure with preserved ejection fraction (HFpEF). The objective was to evaluate if phosphodiesterase V inhibition (PDEVI) alone or combination PDEVI plus B-type natriuretic peptide (BNP) administration will correct the impaired cardiorenal response to VL in PDD. A randomized double-blinded placebo-controlled cross-over study was conducted in 20 subjects with PDD, defined as left ventricular ejection fraction (LVEF) >50% with moderate or severe diastolic dysfunction by Doppler echocardiography and without HF diagnosis or symptoms. Effects of PDEVI with oral tadalafil alone and tadalafil plus subcutaneous (SC) BNP, administered prior to acute volume loading, were assessed. Tadalafil alone did not result in improvement in cardiac response to VL, as measured by LVEF, LV end diastolic volume, left atrial volume (LAV), or right ventricular systolic pressure (RVSP). Tadalafil plus SC BNP resulted in improved cardiac response to VL, with increased LVEF (4.1 vs. 1.8%, p = 0.08) and heart rate (4.3 vs. 1.6 bpm, p = 0.08), and reductions in both LAV (-4.3 ± 10.4 vs. 2.8 ± 6.6 ml, p = 0.03) and RVSP (-4.0 ± 3.0 vs. 2.1 ± 6.0 mmHg, p < 0.01) versus tadalafil alone. Plasma and urinary cyclic guanosine monophosphate (cGMP) excretion levels were higher (11.3 ± 12.3 vs. 1.7 ± 3.8 pmol/ml, 1851.0 ± 1386.4 vs. 173.4 ± 517.9 pmol/min, p < 0.01) with tadalafil plus SC BNP versus tadalafil alone. There was no improvement in renal response as measured by GFR, renal plasma flow, sodium excretion, and urine flow with tadalafil plus SC BNP compared to tadalafil alone. In subjects with PDD, tadalafil alone resulted in no improvement in cardiac adaptation, while tadalafil and SC BNP resulted in enhanced cardiac adaptation to VL. TRIAL REGISTRATION: ClinicalTrials.gov NCT01544998.",2021,"Plasma and urinary cyclic guanosine monophosphate (cGMP) excretion levels were higher (11.3 ± 12.3 vs. 1.7 ± 3.8 pmol/ml, 1851.0 ± 1386.4 vs. 173.4 ± 517.9 pmol/min, p < 0.01) with tadalafil plus SC BNP versus tadalafil alone.","['20\xa0subjects with PDD, defined as left ventricular ejection fraction (LVEF) >50% with moderate or severe diastolic dysfunction by Doppler echocardiography and without HF diagnosis or symptoms', 'human preclinical diastolic dysfunction']","['phosphodiesterase V inhibition (PDEVI) alone or combination PDEVI plus B-type natriuretic peptide (BNP', 'tadalafil', 'Tadalafil', 'Tadalafil plus SC BNP', 'placebo', 'PDEVI with oral tadalafil alone and tadalafil plus subcutaneous (SC) BNP', 'phosphodiesterase V inhibition alone and in combination with BNP']","['cardiac response to VL, with increased LVEF', 'Preclinical diastolic dysfunction (PDD', 'cardiovascular and renal response', 'renal response', 'heart rate', 'Plasma and urinary cyclic guanosine monophosphate (cGMP) excretion levels', 'cardiac response to VL, as measured by LVEF, LV end diastolic volume, left atrial volume (LAV), or right ventricular systolic pressure (RVSP', 'GFR, renal plasma flow, sodium excretion, and urine flow', 'cardiac adaptation', 'cardiac adaptation to VL']","[{'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0757672', 'cui_str': 'Phosphodiesterase 5'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0018338', 'cui_str': 'Cyclic guanosine monophosphate'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0456181', 'cui_str': 'Right ventricular systolic pressure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0206087', 'cui_str': 'Plasma Flow, Renal'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]",,0.0467815,"Plasma and urinary cyclic guanosine monophosphate (cGMP) excretion levels were higher (11.3 ± 12.3 vs. 1.7 ± 3.8 pmol/ml, 1851.0 ± 1386.4 vs. 173.4 ± 517.9 pmol/min, p < 0.01) with tadalafil plus SC BNP versus tadalafil alone.","[{'ForeName': 'Siu-Hin', 'Initials': 'SH', 'LastName': 'Wan', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas-Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'McKie', 'Affiliation': 'Department of Cardiovascular Diseases, Cardiorenal Research Laboratory, Mayo Clinic and Foundation, Rochester, MN, USA.'}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Slusser', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic and Foundation, Rochester, MN, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Burnett', 'Affiliation': 'Department of Cardiovascular Diseases, Cardiorenal Research Laboratory, Mayo Clinic and Foundation, Rochester, MN, USA.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Hodge', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic and Foundation, Rochester, MN, USA.'}, {'ForeName': 'Horng H', 'Initials': 'HH', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Diseases, Cardiorenal Research Laboratory, Mayo Clinic and Foundation, Rochester, MN, USA.'}]",Physiological reports,['10.14814/phy2.14974']
1634,34405547,Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy-induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials.,"BACKGROUND


Supportive care interventions used to manage chemotherapy-induced myelosuppression (CIM), including granulocyte colony-stimulating factors (G-CSFs), erythropoiesis-stimulating agents (ESAs), and red blood cell (RBC) transfusions, are burdensome to patients and associated with greater costs to health care systems. We evaluated the utilization of supportive care interventions and their relationship with the myeloprotective agent, trilaciclib.
METHODS


Data were pooled from three independent randomized phase 2 clinical trials of trilaciclib or placebo administered prior to chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC). The impact of supportive care on the duration of severe neutropenia (DSN), occurrence of severe neutropenia (SN), and occurrence of RBC transfusions on/after week 5 was analyzed across cycles 1-4. Concordance and association between grade 3/4 anemia, RBC transfusions on/after week 5, and ESA administration was also evaluated.
RESULTS


The use of G-CSFs, ESAs, or RBC transfusions on/after week 5 was significantly lower among patients receiving trilaciclib versus placebo (28.5% vs. 56.3%, p < 0.0001; 3.3% vs. 11.8%, p = 0.0254; and 14.6% vs. 26.1%, p = 0.0252, respectively). Compared with placebo, trilaciclib significantly reduced DSN and SN, irrespective of G-CSF administration. RBC transfusions and ESAs were most often administered in patients with grade 3/4 anemia; however, patients typically received RBC transfusions over ESA administration.
CONCLUSIONS


By improving CIM and reducing the need for associated supportive care, trilaciclib has the potential to reduce the burden of myelosuppression on patients receiving myelosuppressive chemotherapy for the treatment of ES-SCLC.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02499770; NCT03041311; NCT02514447).",2021,"The use of G-CSFs, ESAs, or RBC transfusions on/after week 5 was significantly lower among patients receiving trilaciclib versus placebo (28.5% vs. 56.3%, p < 0.0001; 3.3% vs. 11.8%, p = ","['patients with small cell lung cancer', 'patients with extensive-stage small cell lung cancer (ES-SCLC', 'Data were pooled from three independent randomized phase 2 clinical trials of']","['trilaciclib or placebo administered prior to chemotherapy', 'myelosuppressive chemotherapy', 'placebo', 'placebo, trilaciclib']","['duration of severe neutropenia (DSN), occurrence of severe neutropenia (SN), and occurrence of RBC transfusions', 'RBC transfusions and ESAs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]",,0.113188,"The use of G-CSFs, ESAs, or RBC transfusions on/after week 5 was significantly lower among patients receiving trilaciclib versus placebo (28.5% vs. 56.3%, p < 0.0001; 3.3% vs. 11.8%, p = ","[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Ferrarotto', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Anderson', 'Affiliation': 'St Joseph Heritage Healthcare, Santa Rosa, CA, USA.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Medgyasszay', 'Affiliation': 'Veszprém County Lung Medicine Institute, Veszprém, Hungary.'}, {'ForeName': 'Maria Rosario', 'Initials': 'MR', 'LastName': 'García-Campelo', 'Affiliation': 'University Hospital A Coruña, A Coruña, Spain.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Edenfield', 'Affiliation': 'Prisma Health Cancer Institute, Greenville, SC, USA.'}, {'ForeName': 'Trevor M', 'Initials': 'TM', 'LastName': 'Feinstein', 'Affiliation': 'Piedmont Cancer Institute, Atlanta, GA, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Johnson', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Kalmadi', 'Affiliation': 'Ironwood Cancer & Research Center, Chandler, AZ, USA.'}, {'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Lammers', 'Affiliation': 'Baptist Cancer Center, Memphis, TN, USA.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Sanchez-Hernandez', 'Affiliation': 'Hospital Provincial de Castellon, Castelló, Spain.'}, {'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Pritchett', 'Affiliation': 'G1 Therapeutics, Inc., Research Triangle Park, NC, USA.'}, {'ForeName': 'Shannon R', 'Initials': 'SR', 'LastName': 'Morris', 'Affiliation': 'G1 Therapeutics, Inc., Research Triangle Park, NC, USA.'}, {'ForeName': 'Rajesh K', 'Initials': 'RK', 'LastName': 'Malik', 'Affiliation': 'G1 Therapeutics, Inc., Research Triangle Park, NC, USA.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Csőszi', 'Affiliation': 'Hetenyi Geza Korhaz, Szolnok, Hungary.'}]",Cancer medicine,['10.1002/cam4.4089']
1635,34407860,Feasibility of Comparative Health Research Outcome of Novel Surgery in prostate cancer (IP4-CHRONOS): statistical analysis plan for the randomised feasibility phase of the CHRONOS study.,"BACKGROUND


Randomised controlled trials (RCTs) for surgical interventions have often proven difficult with calls for innovative approaches. The Imperial Prostate (IP4) Comparative Health Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS) study aims to deliver level 1 evidence on outcomes following focal therapy which involves treating just the tumour rather than whole-gland surgery or radiotherapy. Our aim is to test the feasibility of two parallel RCTs within an overarching strategy that fits with existing patient and physician equipoise and maximises the chances of success and potential benefit to patients and healthcare services.
METHODS AND DESIGN


IP4-CHRONOS is a randomised, unblinded multi-centre study, including two parallel randomised controlled trials targeting the same patient population: IP4-CHRONOS-A and IP4-CHRONOS-B. IP4-CHRONOS-A is a 1:1 RCT and the other is a multi-arm, multi-stage (MAMS) RCT starting with three arms and a 1:1:1 randomisation. The two linked RCTs are discussed with patients at the time of consent and the choice of A or B is dependent on physician and patient equipoise. The primary outcome is the feasibility of recruitment, acceptance of randomisation and compliance to allocated arm.
RESULTS


This paper describes the statistical analysis plan (SAP) for the feasibility study within IP4-CHRONOS given its innovative approach. Version 1.0 of the SAP has been reviewed by the Trial Steering Committee (TSC), Chief Investigator (CI), Senior Statistician and Trial Statistician and signed off. The study is ongoing and recruiting. Recruitment is scheduled to finish later in 2021. The SAP documents approved methods and analyses that will be conducted. Since this is written in advance of the analysis, we avoid bias arising from prior knowledge of the study data and findings.
DISCUSSION


Our feasibility analysis will demonstrate if IP4-CHRONOS is feasible in terms of recruitment, randomisation and compliance, and whether to continue both A and B or just one to the main stage.
TRIAL REGISTRATION


ISRCTN ISRCTN17796995 . Registered on 08 October 2019.",2021,"Our feasibility analysis will demonstrate if IP4-CHRONOS is feasible in terms of recruitment, randomisation and compliance, and whether to continue both A and B or just one to the main stage.
",['prostate cancer (IP4-CHRONOS'],"['whole-gland surgery or radiotherapy', 'Novel Surgery']","['feasibility of recruitment, acceptance of randomisation and compliance to allocated arm']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C1285092', 'cui_str': 'Gland structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]",,0.363586,"Our feasibility analysis will demonstrate if IP4-CHRONOS is feasible in terms of recruitment, randomisation and compliance, and whether to continue both A and B or just one to the main stage.
","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Day', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.'}, {'ForeName': 'A Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': ""Nightingale-Saunders Unit, King's Clinical Trials Unit, King's College London, London, UK.""}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit at UCL, University College London, London, UK.'}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Reddy', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Taimur T', 'Initials': 'TT', 'LastName': 'Shah', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Winkler', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Dudderidge', 'Affiliation': 'Department of Urology, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'McCracken', 'Affiliation': 'Department of Urology, Sunderland Royal Hospital, Sunderland, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Khoo', 'Affiliation': 'Department of Oncology, The Royal Marsden NHS Foundation and Institute of Cancer Research, London, UK.'}, {'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Jadav', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Klimowska-Nassar', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.'}, {'ForeName': 'Thiagarajah', 'Initials': 'T', 'LastName': 'Sasikaran', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.'}, {'ForeName': 'Hashim U', 'Initials': 'HU', 'LastName': 'Ahmed', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fiorentino', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK. f.fiorentino@imperial.ac.uk.'}]",Trials,['10.1186/s13063-021-05509-w']
1636,34423319,Cognitive-behavioral therapy for adults with avoidant/restrictive food intake disorder.,"There are currently no evidence-based treatments for adults with avoidant/restrictive food intake disorder (ARFID). The purpose of this study was to evaluate the acceptability, feasibility, and proof-of-concept of cognitive-behavioral therapy for ARFID (CBT-AR) for adults. Males and females (ages 18-55 years) were offered 20-30 outpatient sessions of CBT-AR delivered by one of five therapists. Of 18 eligible adults offered CBT-AR, 15 chose to participate and 14 completed treatment. All patients endorsed high ratings of treatment credibility and expected improvement after the first session, and 93% of completers provided high ratings of satisfaction at the conclusion of treatment. Therapists rated the majority (80%) of patients as ""much improved"" or ""very much improved."" Based on intent-to-treat analyses, ARFID severity on the Pica, ARFID, and Rumination Disorder Interview (PARDI) showed a large and significant decrease from pre- to post-treatment; and patients incorporated a mean of 18.0 novel foods. The underweight subgroup ( n  = 4) gained an average of 11.38 pounds, showing a large and significant increase in mean BMI from the underweight to the normal-weight range. At post-treatment, 47% of patients no longer met criteria for ARFID. To our knowledge, this is the first prospective treatment study of ARFID in adults. The findings of this study provide preliminary evidence of feasibility, acceptability, and proof-of-concept of CBT-AR for heterogeneous presentations of ARFID in adults. Randomized controlled trials are needed to confirm these findings. ClinicalTrials.gov Identifier: NCT02963220.",2021,"Therapists rated the majority (80%) of patients as ""much improved"" or ""very much improved.""","['adults with avoidant/restrictive food intake disorder', 'Males and females (ages 18-55 years', 'adults with avoidant/restrictive food intake disorder (ARFID', '18 eligible adults offered CBT-AR, 15 chose to participate and 14 completed treatment', 'adults']","['cognitive-behavioral therapy for ARFID (CBT-AR', 'Cognitive-behavioral therapy']","['mean BMI', 'ARFID severity on the Pica, ARFID, and Rumination Disorder Interview (PARDI', ' or ""very much improved']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3840121', 'cui_str': 'Avoidant restrictive food intake disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C3840121', 'cui_str': 'Avoidant restrictive food intake disorder'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3840121', 'cui_str': 'Avoidant restrictive food intake disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031873', 'cui_str': 'Pica'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0442824', 'cui_str': 'Very'}]",18.0,0.0325599,"Therapists rated the majority (80%) of patients as ""much improved"" or ""very much improved.""","[{'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Thomas', 'Affiliation': 'Eating Disorders Clinical and Research Program, Massachusetts General Hospital, 2 Longfellow Place, Suite 200, Boston, MA 02114, USA.'}, {'ForeName': 'Kendra R', 'Initials': 'KR', 'LastName': 'Becker', 'Affiliation': 'Eating Disorders Clinical and Research Program, Massachusetts General Hospital, 2 Longfellow Place, Suite 200, Boston, MA 02114, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Breithaupt', 'Affiliation': 'Eating Disorders Clinical and Research Program, Massachusetts General Hospital, 2 Longfellow Place, Suite 200, Boston, MA 02114, USA.'}, {'ForeName': 'Helen Burton', 'Initials': 'HB', 'LastName': 'Murray', 'Affiliation': 'Eating Disorders Clinical and Research Program, Massachusetts General Hospital, 2 Longfellow Place, Suite 200, Boston, MA 02114, USA.'}, {'ForeName': 'Jenny H', 'Initials': 'JH', 'LastName': 'Jo', 'Affiliation': 'Eating Disorders Clinical and Research Program, Massachusetts General Hospital, 2 Longfellow Place, Suite 200, Boston, MA 02114, USA.'}, {'ForeName': 'Megan C', 'Initials': 'MC', 'LastName': 'Kuhnle', 'Affiliation': 'Eating Disorders Clinical and Research Program, Massachusetts General Hospital, 2 Longfellow Place, Suite 200, Boston, MA 02114, USA.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Dreier', 'Affiliation': 'Eating Disorders Clinical and Research Program, Massachusetts General Hospital, 2 Longfellow Place, Suite 200, Boston, MA 02114, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Harshman', 'Affiliation': 'Eating Disorders Clinical and Research Program, Massachusetts General Hospital, 2 Longfellow Place, Suite 200, Boston, MA 02114, USA.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Kahn', 'Affiliation': 'Eating Disorders Clinical and Research Program, Massachusetts General Hospital, 2 Longfellow Place, Suite 200, Boston, MA 02114, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Hauser', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, 55 Fruit Street, Bulfinch 457-B, Boston, MA 02114, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Slattery', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, 55 Fruit Street, Bulfinch 457-B, Boston, MA 02114, USA.'}, {'ForeName': 'Madhusmita', 'Initials': 'M', 'LastName': 'Misra', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, 55 Fruit Street, Bulfinch 457-B, Boston, MA 02114, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Lawson', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, 55 Fruit Street, Bulfinch 457-B, Boston, MA 02114, USA.'}, {'ForeName': 'Kamryn T', 'Initials': 'KT', 'LastName': 'Eddy', 'Affiliation': 'Eating Disorders Clinical and Research Program, Massachusetts General Hospital, 2 Longfellow Place, Suite 200, Boston, MA 02114, USA.'}]",Journal of behavioral and cognitive therapy,['10.1016/j.jbct.2020.10.004']
1637,34994614,ctDNA Predicts Overall Survival in Patients With NSCLC Treated With PD-L1 Blockade or With Chemotherapy.,"PURPOSE


Identification of predictors for overall survival (OS) allows timely detection of clinical efficacy signals and therefore facilitates treatment decisions. We assessed the association between circulating tumor DNA (ctDNA) metrics and the primary end point of OS in a subset of previously treated patients with locally advanced or metastatic non-small-cell lung cancer, who underwent atezolizumab or docetaxel treatment in the open-label randomized phase III OAK trial.
MATERIALS AND METHODS


Plasma from 94 patients at baseline and at subsequent cycles of therapy every 3 weeks was analyzed retrospectively for ctDNA. ctDNA was measured by allele frequency and mutant molecules per milliliter (MMPM). Concordance between various per-sample metrics and clinical outcome were assessed using C index.
RESULTS


Of all the ctDNA metrics tested, the association of median MMPM at 6 weeks with OS in patients treated with atezolizumab or docetaxel had a C index > 0.7. The OS hazard ratios relative to high ctDNA above median MMPM within each arm were 0.28 (95% CI, 0.11 to 0.75) for atezolizumab and 0.19 (95% CI, 0.08 to 0.48) for docetaxel. For patients who had ctDNA median MMPM levels of < 4.79, the median survival time was more than 17 months in docetaxel-treated patients and the median survival time was not reached in the atezolizumab-treated patients.
CONCLUSION


ctDNA MMPM levels measured at 6 weeks post-treatment are associated with OS in advanced non-small-cell lung cancer. Our results suggest that ctDNA has the potential for a noninvasive early liquid biopsy predictor for OS that warrants further studies to demonstrate its utility in clinical development.",2021,"RESULTS


Of all the ctDNA metrics tested, the association of median MMPM at 6 weeks with OS in patients treated with atezolizumab or docetaxel had a C index > 0.7.","['Plasma from 94 patients at baseline and at subsequent cycles of therapy every 3 weeks was analyzed retrospectively for ctDNA', 'previously treated patients with locally advanced or metastatic non-small-cell lung cancer, who underwent', 'Patients']","['PD-L1 Blockade or With Chemotherapy', 'atezolizumab or docetaxel treatment', 'docetaxel', 'atezolizumab or docetaxel', 'atezolizumab']","['association of median MMPM', 'Overall Survival', 'allele frequency and mutant molecules per milliliter (MMPM', 'median survival time', 'ctDNA median MMPM levels']","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0017270', 'cui_str': 'Gene frequency'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.223341,"RESULTS


Of all the ctDNA metrics tested, the association of median MMPM at 6 weeks with OS in patients treated with atezolizumab or docetaxel had a C index > 0.7.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zou', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Yaung', 'Affiliation': 'Roche Sequencing Solutions, Inc, Pleasanton, CA.'}, {'ForeName': 'Frederike', 'Initials': 'F', 'LastName': 'Fuhlbrück', 'Affiliation': 'Roche Sequencing Solutions, Inc, Potsdam, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Ballinger', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Peters', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Palma', 'Affiliation': 'Roche Sequencing Solutions, Inc, Pleasanton, CA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Shames', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gandara', 'Affiliation': 'University of California, Davis, CA.'}, {'ForeName': 'Yuqiu', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Roche Sequencing Solutions, Inc, Pleasanton, CA.'}, {'ForeName': 'Namrata S', 'Initials': 'NS', 'LastName': 'Patil', 'Affiliation': 'Genentech, South San Francisco, CA.'}]",JCO precision oncology,['10.1200/PO.21.00057']
1638,34882603,Visual Acuity Outcomes in a Randomized Trial of Wavefront Metric-optimized Refractions in Adults with Down Syndrome.,"SIGNIFICANCE


This study reports visual acuity outcomes from a clinical trial investigating an objective refraction strategy that may provide a useful tool for practitioners needing additional strategies to identify refractive corrections for adults with intellectual disability.
PURPOSE


Determining refractions for individuals with Down syndrome is challenging because of the presence of elevated refractive error, optical aberrations, and cognitive impairment. This randomized clinical trial evaluated the performance of spectacle corrections determined using clinical techniques and objective refractions derived from wavefront aberration measures.
METHODS


Thirty adults with Down syndrome had a clinical refraction determined by a single expert examiner using pre-dilation and post-dilation techniques appropriate for this population. Objective refractions were determined from dilated wavefront aberration measures that were processed post-visit to identify refractions that optimized each of two image quality metrics: pupil fraction tessellated and visual Strehl ratio in the spatial domain. The three refractions were dispensed in random order and worn for 2 months each. The primary outcome measure, binocular visual acuity, was obtained by a masked examiner administering a distance logMAR acuity test. To compare treatment types, mean acuity was compared using a two-sided type 3 F test of the treatment effect in a linear mixed-effects regression model, where the final model included fixed effects for treatment, period (1, 2, or 3), and first-order carryover effects.
RESULTS


The 2-month estimated least square means in binocular visual acuity (logMAR) were 0.34 (95% confidence interval [CI], 0.25 to 0.39) for clinical refractions, 0.31 (95% CI, 0.25 to 0.36) for pupil fraction tesselated refractions, and 0.33 (95% CI, 0.27 to 0.38) for visual Strehl ratio refractions. No statistically significant treatment effect was observed (F = 1.10, P = .34).
CONCLUSIONS


Objective refractions derived from dilated wavefront aberration measures resulted in acuity similar to expert clinician-derived refractions, suggesting that the objective method may be a suitable alternative for patients with Down syndrome.",2022,"CONCLUSIONS


Objective refractions derived from dilated wavefront aberration measures resulted in acuity similar to expert clinician-derived refractions, suggesting that the objective method may be a suitable alternative for patients with Down syndrome.","['individuals with Down syndrome', 'patients with Down syndrome', 'adults with intellectual disability', 'Thirty adults with Down syndrome had a clinical refraction determined by a single expert examiner using pre-dilation and post-dilation techniques appropriate for this population', 'Adults with Down Syndrome']",['Wavefront Metric-optimized Refractions'],"['binocular visual acuity (logMAR', 'Visual Acuity Outcomes', 'binocular visual acuity', 'masked examiner administering a distance logMAR acuity test', 'mean acuity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",30.0,0.192165,"CONCLUSIONS


Objective refractions derived from dilated wavefront aberration measures resulted in acuity similar to expert clinician-derived refractions, suggesting that the objective method may be a suitable alternative for patients with Down syndrome.","[{'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Marsack', 'Affiliation': 'University of Houston, College of Optometry, Houston, Texas.'}, {'ForeName': 'Julia S', 'Initials': 'JS', 'LastName': 'Benoit', 'Affiliation': ''}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Manny', 'Affiliation': 'University of Houston, College of Optometry, Houston, Texas.'}, {'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Fern', 'Affiliation': 'University of Houston, College of Optometry, Houston, Texas.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001834']
1639,34870791,Impact of Gastropexy/Omentopexy on Gastrointestinal Symptoms after Laparoscopic Sleeve Gastrectomy.,"BACKGROUND


Laparoscopic sleeve gastrectomy (LSG) has become a single-step operation for the management of severe obesity. A statistically significant number of participants who undergo this procedure experience nausea, vomiting, and reflux symptoms early after the operation. The objectives of this study were to measure the positive or negative effect of gastropexy on reducing distressing postoperative LSG-related gastrointestinal symptoms.
PATIENTS AND METHODS


This was a comparative randomized study conducted from January 2018 to January 2021. The study was carried out in the general surgery department at Menoufia University Hospital, Menoufia Faculty of Medicine in Egypt. Two hundred participants were included randomly during this trial. The participants were divided into two groups, with 100 patients in each group. Patients in group A underwent gastropexy, and patients in group B underwent LSG without gastropexy.
RESULTS


There was no significant difference between the groups in age or sex (p > 0.05). There was no significant difference in the length of hospital stay (p > 0.05). There was a significant difference between the two groups regarding nausea, vomiting, reflux symptoms, and the amount and frequency of antiemetics used (p < 0.001). There was also a significant difference in hospital readmissions (p < 0.05) and in clinic visits during the postoperative period.
CONCLUSIONS


Patients who underwent gastropexy showed a significant reduction in antiemetic consumption and a significantly lower incidence of postoperative nausea, vomiting, gastroesophageal reflux disease symptoms and gastric torsion than those who did not undergo gastropexy.",2022,"There was also a significant difference in hospital readmissions (p < 0.05) and in clinic visits during the postoperative period.
","['Two hundred participants', 'general surgery department at Menoufia University Hospital, Menoufia Faculty of Medicine in Egypt', 'after Laparoscopic Sleeve Gastrectomy', 'from January 2018 to January 2021']","['Gastropexy/Omentopexy', 'Laparoscopic sleeve gastrectomy (LSG', 'LSG without gastropexy', 'gastropexy']","['nausea, vomiting, reflux symptoms, and the amount and frequency of antiemetics', 'Gastrointestinal Symptoms', 'antiemetic consumption', 'length of hospital stay', 'clinic visits', 'procedure experience nausea, vomiting, and reflux symptoms', 'hospital readmissions', 'postoperative nausea, vomiting, gastroesophageal reflux disease symptoms and gastric torsion']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0192504', 'cui_str': 'Gastropexy'}, {'cui': 'C0600060', 'cui_str': 'Omentopexy'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0038359', 'cui_str': 'Gastric volvulus'}]",200.0,0.0130704,"There was also a significant difference in hospital readmissions (p < 0.05) and in clinic visits during the postoperative period.
","[{'ForeName': 'Hady Saleh', 'Initials': 'HS', 'LastName': 'Abou-Ashour', 'Affiliation': 'General Surgery, Menoufia Faculty of Medicine, General Surgery Department, Menoufia University Hospital, Shebeen El-Kom, Egypt. drhadyabouashour@gmail.com.'}]",Obesity surgery,['10.1007/s11695-021-05806-y']
1640,34399009,"When one suffers less, all suffer less: Individual pain ratings are more effective than group ratings in producing placebo hypoalgesia.","BACKGROUND


Placebo hypoalgesia can be induced by observing a person (model) whose pain relief is the result of the use of an inert substance or procedure. This study examined whether verbal modelling, that is, showing pain ratings provided by other people, is sufficient to induce placebo hypoalgesia.
METHODS


Participants from the experimental groups were acquainted with pain ratings (presented on VASs) derived from a single person (groups 1 and 3) or a group of people (groups 2 and 4) that were allegedly subjected to the same painful procedure. The ratings of pain stimuli that were allegedly applied with placebo were lower than the ratings of stimuli applied without placebo. In two of the experimental groups (group 3 and 4), participants also watched a video recording showing individuals who allegedly provided pain ratings; however, they did not observe them undergoing pain stimulation. The control group did not undergo any manipulation. Then, the participants received a series of the same thermal pain stimuli that were applied either with or without placebo and rated their intensity.
RESULTS


Placebo hypoalgesia was induced only in participants presented with pain ratings provided by a single person, regardless of whether this person was previously seen. However, the pain ratings presented to the participants generally decreased individual pain sensations, regardless of whether they came from a group of people or a single person.
CONCLUSIONS


Verbal modelling can produce placebo hypoalgesia and reduce pain sensations. It may be effectively used in clinical practice to modify patients' responses to pain treatment.
SIGNIFICANCE


This study shows that knowledge about pain ratings provided by another person is sufficient to induce placebo hypoalgesia; thus, neither direct nor indirect observation of a person experiencing pain is necessary to induce this effect. Pain ratings derived from a group of people can decrease pain sensations but they do not produce placebo hypoalgesia.",2022,The ratings of pain stimuli that were allegedly applied with placebo were lower than the ratings of stimuli applied without placebo.,['Participants from the experimental groups were acquainted with pain ratings (presented on VASs) derived from a single person (groups 1 and 3) or a group of people (groups 2 and 4) that were allegedly subjected to the same painful procedure'],['placebo'],"['ratings of pain stimuli', 'pain ratings', 'individual pain sensations', 'pain sensations']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",,0.113547,The ratings of pain stimuli that were allegedly applied with placebo were lower than the ratings of stimuli applied without placebo.,"[{'ForeName': 'Elżbieta Anita', 'Initials': 'EA', 'LastName': 'Bajcar', 'Affiliation': 'Pain Research Group, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Wiercioch-Kuzianik', 'Affiliation': 'Pain Research Group, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Brączyk', 'Affiliation': 'Pain Research Group, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Farley', 'Affiliation': 'Pain Research Group, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Bieniek', 'Affiliation': 'Pain Research Group, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Bąbel', 'Affiliation': 'Pain Research Group, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}]","European journal of pain (London, England)",['10.1002/ejp.1855']
1641,34406549,"Effects of mental simulation of future waterpipe tobacco smoking on attitudes, perceived harms and intended use among young adults.","The desire to engage in waterpipe tobacco smoking (WTS) may occur when smokers and nonsmokers conjure positive mental simulations of WTS. However, effects of these simulations on desire to smoke waterpipe tobacco and potential mediators are unexplored. This research addressed these effects among young adult waterpipe tobacco smokers and nonsmokers. Two online studies were conducted with adults ages 18-30. In Study 1, 200 smokers, 190 susceptible nonsmokers, and 182 nonsusceptible nonsmokers were randomized to mentally simulate or not WTS in the future. In Study 2, 234 smokers and 241 susceptible nonsmokers were randomized to four arms: no simulation or simulations that varied valence of experience (positive, negative or no valence provided). Main outcomes were immediate desire to smoke waterpipe tobacco, cognitive and affective attitudes, and perceived harms. In Study 1, mental simulations increased the desire to smoke waterpipe tobacco among smokers. In Study 2, asking participants to simulate WTS positively or with no valence instruction increased desire to smoke relative to negative valence instruction or no simulation. Negative simulations reduced perceived probability of smoking within a month compared to positive simulations. Effects on desire to engage in WTS were mediated by cognitive and affective attitudes among susceptible nonsmokers and by cognitive attitudes among smokers. These findings suggest that exploring when and how often mental simulations about WTS are evoked and their potency for promoting prevention and cessation of WTS merit further attention.",2022,Effects on desire to engage in WTS were mediated by cognitive and affective attitudes among susceptible nonsmokers and by cognitive attitudes among smokers.,"['young adult waterpipe tobacco smokers and nonsmokers', '200 smokers, 190 susceptible nonsmokers, and 182 nonsusceptible nonsmokers', 'adults ages 18-30', 'young adults', '234 smokers and 241 susceptible nonsmokers']","['no simulation or simulations that varied valence of experience (positive, negative or no valence provided', 'mental simulation of future waterpipe tobacco smoking', 'mentally simulate or not WTS']","['probability of smoking', 'immediate desire to smoke waterpipe tobacco, cognitive and affective attitudes, and perceived harms', 'desire to engage in WTS']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4505131', 'cui_str': 'Waterpipe Tobacco'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C4505131', 'cui_str': 'Waterpipe Tobacco'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4505131', 'cui_str': 'Waterpipe Tobacco'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.0675499,Effects on desire to engage in WTS were mediated by cognitive and affective attitudes among susceptible nonsmokers and by cognitive attitudes among smokers.,"[{'ForeName': 'Isaac M', 'Initials': 'IM', 'LastName': 'Lipkus', 'Affiliation': 'Duke University School of Nursing, Durham, USA. Isaac.lipkus@duke.edu.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': 'Center for Tobacco Research, The Ohio State University Comprehensive Cancer Center, Department of Internal Medicine, The Ohio State University College of Medicine, Columbus, USA.'}, {'ForeName': 'Paschal', 'Initials': 'P', 'LastName': 'Sheeran', 'Affiliation': 'University of North Carolina, Chapel Hill, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': 'Duke University School of Nursing, Durham, USA.'}, {'ForeName': 'Linda D', 'Initials': 'LD', 'LastName': 'Cameron', 'Affiliation': 'University of California, Merced, USA.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'De Brigard', 'Affiliation': 'Duke University, Durham, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-021-00245-7']
1642,34404610,"Electronic Screening, Feedback, and Clinician Training in Adolescent Primary Care: A Stepped-Wedge Cluster Randomized Trial.","PURPOSE


The aim of this study is to test the effects of an electronic screening and feedback tool and training for primary care clinicians on care and adolescent health behaviors.
METHODS


We conducted a stepped-wedge cluster randomized trial with six clinics randomly assigned to sequential crossover from control to intervention periods with clinician training between periods. Adolescents (ages 13-18) with a well visit during the control periods (n = 135) received usual care, while adolescents during the intervention periods (n = 167) received the electronic screening and feedback tool prior to their well visit, with results sent to their clinicians. Adolescents completed surveys at baseline, 1 day, 3 months, 6 months, and 12 months. Linear mixed effects models were used to examine associations between outcomes and treatment, controlling for time as a fixed effect and clinic as a random effect. All analyses employed intent-to-treat analyses and utilized multiple imputations for missing data.
RESULTS


Adolescents who received the intervention had a higher rate of counseling for their endorsed risk behaviors during the well visit (45% vs. 33%, Wald's T = 2.29, p = .02). There were no significant intervention effects on adolescent satisfaction with the clinician or perception of patient centeredness. The intervention was associated with a small but statistically significant reduction in overall risk score relative to control at 3 months (-.63, 95% confidence interval [-1.07, -.19], Cohen's d = .21), but not at 6 or 12 months.
CONCLUSIONS


The results suggest that electronic screening and feedback may be associated with small reductions in risk behaviors at 3 months but that changes do not persist at longer term follow-up.",2022,"The intervention was associated with a small but statistically significant reduction in overall risk score relative to control at 3 months (-.63, 95% confidence interval [-1.07, -.19], Cohen's d = .21), but not at 6 or 12 months.
","['Adolescent Primary Care', 'Adolescents (ages 13-18) with a well visit during the control periods (n\xa0= 135) received usual care, while adolescents during the intervention periods (n\xa0= 167) received the', 'primary care clinicians on care and adolescent health behaviors']","['Electronic Screening, Feedback, and Clinician Training', 'electronic screening and feedback tool prior to their well visit', 'electronic screening and feedback tool and training']","['adolescent satisfaction', 'risk behaviors', 'overall risk score', 'higher rate of counseling for their endorsed risk behaviors']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C1456722', 'cui_str': 'Teen Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",6.0,0.0535413,"The intervention was associated with a small but statistically significant reduction in overall risk score relative to control at 3 months (-.63, 95% confidence interval [-1.07, -.19], Cohen's d = .21), but not at 6 or 12 months.
","[{'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'McCarty', 'Affiliation': ""Seattle Children's Research Institute, Center for Child Health Behavior, and Development, Seattle, Washington; Department of Pediatrics, University of Washington, Seattle, Washington. Electronic address: carolyn.mccarty@seattlechildrens.org.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Parker', 'Affiliation': ""Seattle Children's Research Institute, Center for Child Health Behavior, and Development, Seattle, Washington.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Seattle Children's Research Institute, Center for Child Health Behavior, and Development, Seattle, Washington; Department of Pediatrics, University of Washington, Seattle, Washington.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Katzman', 'Affiliation': ""Seattle Children's Research Institute, Center for Child Health Behavior, and Development, Seattle, Washington.""}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Stout', 'Affiliation': ""Seattle Children's Research Institute, Center for Child Health Behavior, and Development, Seattle, Washington; Department of Pediatrics, University of Washington, Seattle, Washington.""}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Richardson', 'Affiliation': ""Seattle Children's Research Institute, Center for Child Health Behavior, and Development, Seattle, Washington; Department of Pediatrics, University of Washington, Seattle, Washington.""}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2021.07.019']
1643,34404606,A Randomized Controlled Trial of Tai Chi Chih or Health Education for Geriatric Depression.,"OBJECTIVES


Geriatric depression is difficult to treat and frequently accompanied by treatment resistance, suicidal ideations and polypharmacy. New adjunctive mind-body treatment strategies can improve clinical outcomes in geriatric depression and reduce risk for side-effects of pharmacological treatments.
METHODS


We conducted a 3-month randomized controlled trial to assess the efficacy and tolerability of combining Tai Chi Chih (TCC) or Health Education and Wellness training (HEW) with the stable standard antidepressant treatment on mood and cognitive functioning in depressed older adults (NCT02460666). Primary outcome was change in depression as assessed by the Hamilton Rating Scale for Depression (HAM-D) post-treatment. Remission was defined as HAM-D ≤ 6; naturalistic follow-up continued for 6 months. We also assessed psychological resilience, health-related quality of life and cognition.
RESULTS


Of the 178 randomized participants, 125 completed the 3-month assessment and 117 completed the 6-month assessment. Dropout and tolerability did not differ between groups. Remission rate within TCC was 35.5% and 33.3%, compared to 27.0% and 45.8% in HEW, at 3 and 6 months respectively (χ 2 (1) = 1.0, p = 0.3; χ 2 (1) = 1.9, p =0.2). Both groups improved significantly on the HAM-D at 3 and 6 months. TCC demonstrated a greater improvement in general health compared to HEW.
CONCLUSIONS


Both TCC and HEW combined with a standard antidepressant treatment improved symptoms of depression in older adults. While TCC was superior to HEW in improving general health, we did not find group differences in improvement in mood and cognition.",2022,Primary outcome was change in depression as assessed by the Hamilton Rating Scale for Depression (HAM-D) post-treatment.,"['depressed older adults (NCT02460666', 'Geriatric Depression', 'older adults', '178 randomized participants']","['combining Tai Chi Chih (TCC) or Health Education and Wellness training (HEW', 'TCC', 'Tai Chi Chih or Health Education']","['psychological resilience, health-related quality of life and cognition', 'Dropout and tolerability', 'change in depression as assessed by the Hamilton Rating Scale for Depression (HAM-D', 'symptoms of depression', 'efficacy and tolerability', 'mood and cognition', 'mood and cognitive functioning', 'general health', 'HAM-D', 'Remission rate within TCC']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}]",178.0,0.0697708,Primary outcome was change in depression as assessed by the Hamilton Rating Scale for Depression (HAM-D) post-treatment.,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lavretsky', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, CA. Electronic address: hlavretsky@mednet.ucla.edu.'}, {'ForeName': 'Michaela M', 'Initials': 'MM', 'LastName': 'Milillo', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, CA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kilpatrick', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, CA.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Grzenda', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, CA.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Wu', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, CA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Nguyen', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, CA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Ercoli', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, CA.'}, {'ForeName': 'Prabha', 'Initials': 'P', 'LastName': 'Siddarth', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, CA.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2021.07.008']
1644,34414678,"Budesonide as induction therapy for incomplete microscopic colitis: A randomised, placebo-controlled multicentre trial.","BACKGROUND AND AIMS


Incomplete microscopic colitis (MCi) is a subtype of microscopic colitis (MC). Budesonide is recommended as a first-line treatment for MC. However, randomised trials on efficacy of treatment in MCi are missing. We therefore performed a randomised, placebo-controlled trial to evaluate budesonide as induction therapy for MCi.
METHODS


Patients with active MCi were randomly assigned to either budesonide 9 mg once daily or placebo for 8 weeks in a double-blind, double-dummy design. The primary endpoint was clinical remission, defined as a mean of <3 stools/day and a mean of <1 watery stool/day in the 7 days before week 8.
RESULTS


Due to insufficient patient recruitment, the trial was discontinued prematurely. The intention-to-treat analysis included 44 patients (21 budesonide and 23 placebo). The primary endpoint of clinical remission at week 8 was obtained by 71.4% on budesonide and 43.5% on placebo (p = 0.0582). All clinical secondary endpoints were in favour of budesonide. Budesonide decreased the number of soft or watery stools (16.3 vs. 7.7, p = 0.0186) and improved health-related quality of life for all four dimensions of the short health scale. Adverse events with a suspected relation to study drug were reported in one patient in the budesonide group and two patients in the placebo group. Neither serious nor severe adverse events occurred during the double-blind phase.
CONCLUSIONS


Budesonide decreased the frequency of soft or watery stools and improved the patients' quality of life significantly in MCi, but the primary endpoint was not met due to the low sample size (type 2 error). Budesonide was safe and well tolerated during the 8-weeks treatment course.",2021,"Budesonide decreased the number of soft or watery stools (16.3 vs. 7.7, p = 0.0186) and improved health-related quality of life for all four dimensions of the short health scale.","['44 patients (21', 'Patients with active MCi', 'incomplete microscopic colitis']","['Budesonide', 'budesonide and 23 placebo', 'placebo', 'budesonide', 'budesonide 9\xa0mg once daily or placebo']","['safe and well tolerated', ""patients' quality of life"", 'severe adverse events', 'health-related quality of life', 'Adverse events', 'clinical remission', 'frequency of soft or watery stools', 'number of soft or watery stools', 'clinical remission, defined as a mean of <3 stools/day and a mean of <1 watery stool/day']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0400821', 'cui_str': 'Microscopic colitis'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3531316', 'cui_str': 'Budesonide 9 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",44.0,0.806013,"Budesonide decreased the number of soft or watery stools (16.3 vs. 7.7, p = 0.0186) and improved health-related quality of life for all four dimensions of the short health scale.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Münch', 'Affiliation': 'Department of Gastroenterology and Hepatology, Linköping University Hospital School of Medicine, Linköping, Sweden.'}, {'ForeName': 'Emese', 'Initials': 'E', 'LastName': 'Mihaly', 'Affiliation': 'Department of Internal Medicine, Semmelweis Egyetem, Budapest, Hungary.'}, {'ForeName': 'Ferenc', 'Initials': 'F', 'LastName': 'Nagy', 'Affiliation': 'First Department of Medicine, Szegedi Egyetem ÁOK I sz., Szeged, Hungary.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Madisch', 'Affiliation': 'Medical Department I, KRH Klinikum Siloah, Hannover, Germany.'}, {'ForeName': 'Juozas', 'Initials': 'J', 'LastName': 'Kupčinskas', 'Affiliation': 'Department of Gastroenterology, Institute for Digestive Research, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Miehlke', 'Affiliation': 'Center for Digestive Diseases, Internal Medicine Center Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Bohr', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Örebro University Hospital, Örebro, Sweden.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Bouma', 'Affiliation': 'Department of Gastroenterology, Vrije Universiteit Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Guardiola', 'Affiliation': 'Department of Digestive Diseases, Hospital Universitario de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Belloc', 'Affiliation': 'Department of Gastroenterology, Hospital San Jorge - University of Zaragoza, Huesca, Spain.'}, {'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology, Norrlands Universitetssjukhus, Umeå, Sweden.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Aust', 'Affiliation': 'Institute for Pathology, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Mohrbacher', 'Affiliation': 'Clinical Research and Development Department, Dr Falk Pharma GmbH, Freiburg, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Greinwald', 'Affiliation': 'Clinical Research and Development Department, Dr Falk Pharma GmbH, Freiburg, Germany.'}, {'ForeName': 'Lars Kristian', 'Initials': 'LK', 'LastName': 'Munck', 'Affiliation': 'Department of Gastroenterology, Zealand University Hospital, Køge, Denmark.'}]",United European gastroenterology journal,['10.1002/ueg2.12131']
1645,34423832,"The Effect of Preoperative Methylprednisolone on Postoperative Delirium in Older Patients Undergoing Gastrointestinal Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND


Preoperative administration of methylprednisolone reduced circulating markers of endothelial activation. This randomized, double-blind, placebo-controlled trial was to evaluate whether a single preoperative dose of methylprednisolone reduced the rate of postoperative delirium (POD) in older patients undergoing gastrointestinal surgery and its association with the shedding of endothelial glycocalyx markers.
METHODS


About 168 patients, aged 65-80 years and scheduled for laparoscopic gastrointestinal surgery, were randomized to 2 mg/kg methylprednisolone (Group M, n = 84) or equivalent dose of placebo (Group C, n = 84). The primary outcome was the incidence of delirium during the first 5 days after surgery, assessed by the Confusion Assessment Method (CAM). POD severity was rated daily using CAM-Severity (CAM-S). Levels of syndecan-1, heparan sulfate, tumor necrosis factor-α (TNF-α), and brain-derived neurotrophic factor (BDNF) were measured at baseline, 1 day, and 3 days after surgery.
RESULTS


Compared with placebo, methylprednisolone greatly reduced the incidence of delirium at 72 hours following surgery (9 [10.7%] vs 20 [23.8%], p = .03, OR = 2.22 [95% CI 1.05-4.59]). No between-group difference was found in the cumulative CAM-S score (p = .14). The levels of heparan sulfate, syndecan-1, and TNF-α in Group M were lower than that in Group C (p < .05 and p < .01), while the level of BDNF in Group M was higher than that in Group C (p < .01).
CONCLUSIONS


Preoperative administration of methylprednisolone does not reduce the severity of POD, but may reduce the incidence of delirium after gastrointestinal surgery in older patients, which may be related to a reduction in circulating markers of endothelial degradation, followed by the increase of BDNF level.
CLINICAL TRIALS REGISTRATION NUMBER


Chinese Clinical Trial.gov, ChiCTR2000028792. Registered January 4, 2020. http://www.chictr.org.cn/showproj.aspx?proj=47807.",2022,"The levels of heparan sulfate, syndecan-1, and TNF-α in Group M were lower than that in Group C (P <0.05 and P <0.01), while the level of BDNF in Group M was higher than that in Group C (P <0.01).
","['elderly patients undergoing gastrointestinal surgery', 'elderly patients', '168 patients, aged 65-80 years and scheduled for laparoscopic gastrointestinal surgery', 'older patients undergoing gastrointestinal surgery, and its association with the shedding of endothelial glycocalyx markers']","['placebo, methylprednisolone', 'mg·kg -1 methylprednisolone', 'methylprednisolone', 'pre-operative methylprednisolone', 'placebo']","['POD severity', 'postoperative delirium', 'incidence of delirium', 'rate of postoperative delirium (POD', 'severity of POD', 'incidence of delirium during the first 5 days after surgery, assessed by the confusion assessment method (CAM', 'cumulative CAM-S score', 'Level of syndecan-1, heparan sulfate, tumor necrosis factor-α(TNF-α), and brain-derived neurotrophic factor (BDNF', 'level of BDNF', 'levels of heparan sulfate, syndecan-1, and TNF-α']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0019143', 'cui_str': 'Heparan sulfate'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}]",168.0,0.631943,"The levels of heparan sulfate, syndecan-1, and TNF-α in Group M were lower than that in Group C (P <0.05 and P <0.01), while the level of BDNF in Group M was higher than that in Group C (P <0.01).
","[{'ForeName': 'Xiao-Bing', 'Initials': 'XB', 'LastName': 'Xiang', 'Affiliation': 'Department of Anesthesiology, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ying-Li', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Yue', 'Affiliation': 'Department of Anesthesiology, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.'}, {'ForeName': 'Xin-Qi', 'Initials': 'XQ', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Hefei, China.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glab248']
1646,34421382,Clinical effectiveness and costs of pre-hospital inhaled methoxyflurane for acute pain in trauma in adults: non-randomised control group study.,"Aims


Inhaled methoxyflurane, newly licensed in Europe for acute trauma pain in adults, has limited evidence of effectiveness in the pre-hospital setting. We aimed to investigate the clinical effectiveness and costs of methoxyflurane delivered when administered by ambulance staff compared with usual analgesic practice (UAP) for adults with trauma.
Methods


A non-randomised control group design was used to compare methoxyflurane versus Entonox ®  or parenteral analgesics. Verbal numerical pain scores (VNPS) were gathered over time in adults with moderate to severe trauma pain attended by ambulance staff trained in administering and supplied with methoxyflurane. Comparator VNPS were obtained from database records of UAP in similar patients. Clinical efficacy was tested using an Ordered Probit panel regression model of pain intensity linked by observational rules to VNPS. Scenario analyses were used to compare durations under analgesia spent in severe pain, and costs.
Results


Over the 12-month evaluation period, 96 trained paramedics and technicians prepared 510 doses of methoxyflurane for administration to a grand total of 483 patients. Thirty-two patients reported side effects, 19 of whom discontinued early. Thirteen patients, 10 aged over 75 years, were nonadherent to instructions given on inhaler use. Modelling results included demonstration of statistically significant clinical effectiveness of methoxyflurane over each comparator (all p-values <0.001). Methoxyflurane's time to achieve maximum pain relief was significantly faster (all p-values <0.001): 25.7 mins (95%CI 24.4-27.0) versus Entonox ®  44.4 (39.5-49.3); 25.8 (24.5-27.1) versus IV paracetamol 40.7 (34.6-46.9); 25.7 (24.4-27.0) versus IV morphine sulfate 41.9 (38.9-44.8). Scenario analyses of time spent in severe pain (VNPS on administration just scoring 10 reducing to a score of 7) were significantly less for methoxyflurane (all difference p-values <0.001): 7.6 mins (95%CI 6.5-8.7) versus Entonox ®  24.6 (20.1-29.0); 6.7 (5.6-7.7) versus IV paracetamol 23.0 (17.9-28.0); 6.9 (5.9-7.9) versus IV morphine sulfate 14.9 (13.3-16.6). Costing scenarios compared single-dose use of methoxyflurane versus Entonox ®  and versus parenteral analgesics (80-20% weighted episode mix of morphine sulfate and paracetamol). In both scenarios, the benefits of methoxyflurane were achieved at higher cost: the additional cost per treated patient was £8.77 versus Entonox ®  and £9.69 versus parenteral analgesics. The BNF list price for one vial containing a 3 mL dose of methoxyflurane for vaporisation in a Penthrox ®  inhaler is £17.89 per pack.
Conclusion


Methoxyflurane administered by ambulance clinicians reduced moderate or severe pain due to trauma in adults more rapidly compared to Entonox ®  or parenteral drugs. Methoxyflurane provides a useful addition to pre-hospital analgesia.",2021,Methoxyflurane's time to achieve maximum pain relief was significantly faster (all p-values <0.001): 25.7 mins (95%CI 24.4-27.0) versus Entonox ®  44.4 (39.5-49.3); 25.8 (24.5-27.1) versus IV paracetamol 40.7 (34.6-46.9); 25.7 (24.4-27.0) versus IV morphine sulfate 41.9 (38.9-44.8).,"['adults with moderate to severe trauma pain attended by ambulance staff trained in administering and supplied with', 'acute pain in trauma in adults', 'Thirteen patients, 10 aged over 75 years', 'adults with trauma']","['methoxyflurane versus Entonox ®  and versus parenteral analgesics', 'methoxyflurane versus Entonox ®  or parenteral analgesics', 'morphine sulfate and paracetamol', 'usual analgesic practice (UAP', 'methoxyflurane', 'Methoxyflurane', 'morphine sulfate', 'pre-hospital inhaled methoxyflurane']","['moderate or severe pain', 'durations under analgesia spent in severe pain, and costs', 'Verbal numerical pain scores (VNPS', 'maximum pain relief', 'side effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0025688', 'cui_str': 'Methoxyflurane'}, {'cui': 'C0059395', 'cui_str': 'Entonox'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0066814', 'cui_str': 'Morphine sulfate'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",483.0,0.0966696,Methoxyflurane's time to achieve maximum pain relief was significantly faster (all p-values <0.001): 25.7 mins (95%CI 24.4-27.0) versus Entonox ®  44.4 (39.5-49.3); 25.8 (24.5-27.1) versus IV paracetamol 40.7 (34.6-46.9); 25.7 (24.4-27.0) versus IV morphine sulfate 41.9 (38.9-44.8).,"[{'ForeName': 'A Niroshan', 'Initials': 'AN', 'LastName': 'Siriwardena', 'Affiliation': 'University of Lincoln; East Midlands Ambulance Service NHS Trust.'}, {'ForeName': 'Murray D', 'Initials': 'MD', 'LastName': 'Smith', 'Affiliation': 'University of Lincoln.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Rowan', 'Affiliation': 'University of Lincoln.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Spaight', 'Affiliation': 'East Midlands Ambulance Service NHS Trust.'}]",British paramedic journal,['10.29045/14784726.2021.3.5.4.66']
1647,34419597,Right Ventricular Ejection Fraction and Beta-Blocker Effect in Heart Failure With Reduced Ejection Fraction.,"BACKGROUND


A low right ventricular ejection fraction (RVEF) is a marker of poor outcomes in patients with heart failure with reduced ejection fraction (HFrEF). Beta-blockers improve outcomes in HFrEF, but whether this effect is modified by RVEF is unknown.
METHODS AND RESULTS


Of the 2798 patients in Beta-Blocker Evaluation of Survival Trial (BEST), 2008 had data on baseline RVEF (mean 35%, median 34%). Patients were categorized into an RVEF of less than 35% (n = 1012) and an RVEF of 35% or greater (n = 996). We estimated hazard ratios (HRs) and 95% confidence intervals (CIs) within each RVEF subgroup and formally tested for interactions between bucindolol and RVEF. The effect of bucindolol on all-cause mortality in 2008 patients with baseline RVEF (HR 0.88, 95% CI 0.75-1.02) is consistent with that in 2798 patients in the main trial (HR 0.90, 95% CI 0.78-1.02). Bucindolol use was associated with a lower risk of all-cause mortality in patients with an RVEF of 35% or greater (HR 0.70, 95% CI 0.55-0.89), but not in those with an RVEF of less than 35% (HR 1.02, 95% CI 0.83-1.24, P for interaction = .022). Similar variations were observed for cardiovascular mortality (P for interaction = .009) and sudden cardiac death (P for interaction = .018), but not for pump failure death (P for interaction = .371) or HF hospitalization (P for interaction = .251).
CONCLUSIONS


The effect of bucindolol on mortality in patients with HFrEF was modified by the baseline RVEF. If these hypothesis-generating findings can be replicated using approved beta-blockers in contemporary patients with HFrEF, then RVEF may help to risk stratify patients with HFrEF for optimization of beta-blocker therapy.",2022,"Bucindolol use was associated with a lower risk of all-cause mortality in patients with RVEF ≥35% (HR, 0.70; 95% CI, 0.55-0.89), but not in those with RVEF <35% (HR, 1.02; 95% CI, 0.83-1.24; p for interaction, 0.022).","['Of the 2798 patients in Beta-Blocker Evaluation of Survival Trial (BEST), 2008 had data on baseline RVEF (mean, 35%; median, 34', 'patients with heart failure with reduced ejection fraction (HFrEF', 'Heart Failure with Reduced Ejection Fraction', 'patients with HFrEF', '2008 patients with baseline RVEF (HR, 0.88; 95% CI, 0.75-1.02']","['low right ventricular ejection fraction (RVEF', 'bucindolol']","['pump failure death', 'sudden cardiac death', 'HF hospitalization', 'cardiovascular mortality', 'lower risk of all-cause mortality', 'hazard ratio (HR', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0428781', 'cui_str': 'Right ventricular ejection fraction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4517484', 'cui_str': '0.88'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C4068882', 'cui_str': '0.75'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0428781', 'cui_str': 'Right ventricular ejection fraction'}, {'cui': 'C0054196', 'cui_str': 'bucindolol'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",2798.0,0.213436,"Bucindolol use was associated with a lower risk of all-cause mortality in patients with RVEF ≥35% (HR, 0.70; 95% CI, 0.55-0.89), but not in those with RVEF <35% (HR, 1.02; 95% CI, 0.83-1.24; p for interaction, 0.022).","[{'ForeName': 'Phillip H', 'Initials': 'PH', 'LastName': 'Lam', 'Affiliation': 'Department of Medicine, Veterans Affairs Medical Center, Washington, DC; Department of Cardiology, MedStar Washington Hospital Center, Washington, DC; Department of Medicine, Georgetown University, Washington, DC. Electronic address: lp30884@gmail.com.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Keramida', 'Affiliation': 'Department of Cardiology, Attikon University Hospital, Athens, Greece; Department of Cardiology, National Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Gerasimos S', 'Initials': 'GS', 'LastName': 'Filippatos', 'Affiliation': 'Department of Cardiology, Attikon University Hospital, Athens, Greece; Department of Cardiology, National Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Veterans Affairs Medical Center, Washington, DC; Department of Cardiology, MedStar Washington Hospital Center, Washington, DC; Department of Medicine, Georgetown University, Washington, DC.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Faselis', 'Affiliation': 'Department of Medicine, Veterans Affairs Medical Center, Washington, DC; Department of Medicine, Georgetown University, Washington, DC; Uniformed Services University, Washington, DC.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Deedwania', 'Affiliation': 'Department of Medicine, Veterans Affairs Medical Center, Washington, DC; Department of Medicine, University of California, San Francisco, California.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'George', 'Affiliation': 'College of Population Health, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Iskandrian', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials, University of Glasgow; National Heart & Lung Institute, Imperial College London, Glasgow, UK.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Choudhary', 'Affiliation': 'Department of Medicine, Veterans Affairs Medical Center, Providence, Rhode Island; Department of Medicine, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Wen-Chih', 'Initials': 'WC', 'LastName': 'Wu', 'Affiliation': 'Department of Medicine, Veterans Affairs Medical Center, Providence, Rhode Island; Department of Medicine, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Charity J', 'Initials': 'CJ', 'LastName': 'Morgan', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, California.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Department of Medicine, Veterans Affairs Medical Center, Washington, DC; Department of Medicine, Georgetown University, Washington, DC. Electronic address: ali.ahmed@va.gov.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2021.07.026']
1648,34419564,Positron Emission Tomography-Guided Bone Marrow-Sparing Radiation Therapy for Locoregionally Advanced Cervix Cancer: Final Results From the INTERTECC Phase II/III Trial.,"PURPOSE


To test effects of positron emission tomography (PET)-based bone marrow-sparing (BMS) image-guided intensity modulated radiation therapy (IG-IMRT) on efficacy and toxicity for patients with locoregionally advanced cervical cancer.
METHODS AND MATERIALS


In an international phase II/III trial, patients with stage IB-IVA cervical carcinoma were treated with either PET-based BMS-IG-IMRT (PET-BMS-IMRT group) or standard image-guided IMRT (IMRT group), with concurrent cisplatin (40 mg/m 2  weekly), followed by brachytherapy. The phase II component nonrandomly assigned patients to PET-BMS-IMRT or standard IMRT. The phase III trial randomized patients to PET-BMS-IMRT versus IMRT, with a primary endpoint of progression-free survival (PFS) but was closed early for futility. Phase III patients were analyzed separately and in combination with phase II patients, comparing acute hematologic toxicity, cisplatin delivery, PFS, overall survival (OS), and patterns of failure. In a post-hoc exploratory analysis, we investigated the association between pretreatment absolute lymphocyte count (ALC) and OS.
RESULTS


In total, 101 patients were enrolled on the phase II/III trial, including 29 enrolled in phase III (PET-BMS-IMRT group: 16; IMRT group: 13) before early closure. Median follow-up was 33 months for phase III patients and 39 months for all patients. PFS and OS at 5 years for all patients were 73.6% (95% confidence interval [CI], 64.9%-84.3%) and 84% (95% CI, 76%-92.9%]), respectively. There were no differences in number of cisplatin cycles, OS, PFS, or patterns of failure between groups for the combined cohort. The incidence of acute grade ≥ 3 neutropenia was significantly lower in the PET-BMS-IMRT group compared with IMRT for randomized patients (19% vs 54%, χ 2 P = .048) and in the combined cohort (13% vs 35%, χ 2 P = .01). Patients with pretreatment ALC ≤ 1.5 k/µL had nonsignificantly worse OS on multivariable analysis (HR 2.85; 95% CI, 0.94-8.62; adjusted P = .216), compared with patients with ALC > 1.5 k/µL. There was no difference in posttreatment ALC by treatment group.
CONCLUSIONS


PET-BMS-IMRT significantly reduced acute grade ≥3 neutropenia, but not treatment-related lymphopenia, compared with standard IMRT. We found no evidence that PET-BMS-IMRT affected chemotherapy delivery or long-term outcomes, and weak evidence of an association between pretreatment ALC and OS.",2022,"The incidence of acute grade ≥ 3 neutropenia was significantly lower in the PET-BMS-IMRT group compared to IMRT for randomized patients (19% versus 54%, c 2  p=0.048) and in the combined cohort (13% vs. 35%, c 2  p=0.01).","['Locoregionally Advanced Cervix Cancer', '101 patients were enrolled on the phase II/III trial, including 29 enrolled in phase III (PET-BMS-IMRT group: 16; IMRT group: 13) before early closure', 'patients with locoregionally advanced cervical cancer', 'patients with stage IB-IVA cervical carcinoma']","['PET-BMS-IMRT', 'PET-BMS-IMRT or standard IMRT', 'positron emission tomography (PET)-based bone marrow-sparing (BMS) image-guided intensity modulated radiation therapy (IMRT', 'Positron Emission Tomography-Guided Bone Marrow-Sparing Radiation Therapy', 'PET-based BMS-IG-IMRT (PET-BMS-IMRT group) or standard image-guided IMRT (IMRT group), with concurrent cisplatin', 'PET-BMS-IMRT vs. IMRT']","['number of cisplatin cycles, OS, PFS, or patterns of failure', 'efficacy and toxicity', 'incidence of acute grade ≥ 3 neutropenia', 'PFS and OS', 'acute grade ≥ 3 neutropenia', 'acute hematologic toxicity, cisplatin delivery, PFS, overall survival (OS), and patterns of failure', 'progression-free survival (PFS', 'absolute lymphocyte count (ALC) and OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}]","[{'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}]",101.0,0.0471641,"The incidence of acute grade ≥ 3 neutropenia was significantly lower in the PET-BMS-IMRT group compared to IMRT for randomized patients (19% versus 54%, c 2  p=0.048) and in the combined cohort (13% vs. 35%, c 2  p=0.01).","[{'ForeName': 'Casey W', 'Initials': 'CW', 'LastName': 'Williamson', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Sirák', 'Affiliation': 'Department of Oncology and Radiotherapy, University Hospital, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Ronghui', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'University of California San Diego, La Jolla, California.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Portelance', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Lichun', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Xijing Hospital, Xian, China.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Tarnawski', 'Affiliation': 'Marie Sklodowska Cancer Center and Institute of Oncology, Gliwice, Poland.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Mahantshetty', 'Affiliation': 'Tata Memorial Centre, Parel, Mumbai, India.'}, {'ForeName': 'Elena S', 'Initials': 'ES', 'LastName': 'Heide', 'Affiliation': 'University of California Irvine, Irvine, California.'}, {'ForeName': 'Catheryn M', 'Initials': 'CM', 'LastName': 'Yashar', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'McHale', 'Affiliation': 'University of California San Diego, La Jolla, California.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Bosch', 'Affiliation': 'Department of Radiation Oncology, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lowenstein', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Cheryl C', 'Initials': 'CC', 'LastName': 'Saenz', 'Affiliation': 'University of California San Diego, La Jolla, California.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Plaxe', 'Affiliation': 'University of California San Diego, La Jolla, California.'}, {'ForeName': 'Ramez', 'Initials': 'R', 'LastName': 'Eskander', 'Affiliation': 'University of California San Diego, La Jolla, California.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Einck', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Arno J', 'Initials': 'AJ', 'LastName': 'Mundt', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Mayadev', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California; La Jolla Center for Precision Radiation Medicine, La Jolla, California.'}, {'ForeName': 'Loren K', 'Initials': 'LK', 'LastName': 'Mell', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California; La Jolla Center for Precision Radiation Medicine, La Jolla, California. Electronic address: lmell@ucsd.edu.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.08.019']
1649,34425251,Widespread Pressure Delivered by a Weighted Blanket Reduces Chronic Pain: A Randomized Controlled Trial.,"Pleasant sensation is an underexplored avenue for modulation of chronic pain. Deeper pressure is perceived as pleasant and calming, and can improve sleep. Although pressure can reduce acute pain, its effect on chronic pain is poorly characterized. The current remote, double-blind, randomized controlled trial tested the hypothesis that wearing a heavy weighted blanket - providing widespread pressure to the body - relative to a light weighted blanket would reduce ratings of chronic pain, mediated by improvements in anxiety and sleep. Ninety-four adults with chronic pain were randomized to wear a 15-lb. (heavy) or 5-lb. (light) weighted blanket during a brief trial and overnight for one week. Measures of anxiety and chronic pain were collected pre- and post-intervention, and ratings of pain intensity, anxiety, and sleep were collected daily. After controlling for expectations and trait anxiety, the heavy weighted blanket produced significantly greater reductions in broad perceptions of chronic pain than the light weighted blanket (Cohen's f = .19, CI [-1.97, -.91]). This effect was stronger in individuals with high trait anxiety (P = .02). However, weighted blankets did not alter pain intensity ratings. Pain reductions were not mediated by anxiety or sleep. Given that the heavy weighted blanket was associated with greater modulation of affective versus sensory aspects of chronic pain, we propose that the observed reductions are due to interoceptive and social/affective effects of deeper pressure. Overall, we demonstrate that widespread pressure from a weighted blanket can reduce the severity of chronic pain, offering an accessible, home-based tool for chronic pain. The study purpose, targeted condition, study design, and primary and secondary outcomes were pre-registered in ClinicalTrials.gov (NCT04447885: ""Weighted Blankets and Chronic Pain""). PERSPECTIVE: This randomized-controlled trial showed that a 15-lb weighted blanket produced significantly greater reductions in broad perceptions of chronic pain relative to a 5-lb weighted blanket, particularly in highly anxious individuals. These findings are relevant to patients and providers seeking home-based, nondrug therapies for chronic pain relief.",2022,"After controlling for expectations and trait anxiety, the heavy weighted blanket produced significantly greater reductions in broad perceptions of chronic pain than the light weighted blanket (Cohen's f = .19, CI [-1.97, -.91]).",['Ninety-four adults with chronic pain'],"['15-lb weighted blanket', 'heavy weighted blanket']","['anxiety or sleep', 'acute pain', 'anxiety and chronic pain', 'anxiety and sleep', 'pain intensity ratings', 'chronic pain', 'Pain reductions', 'ratings of pain intensity, anxiety, and sleep', 'severity of chronic pain']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0179330', 'cui_str': 'Blanket'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",94.0,0.36444,"After controlling for expectations and trait anxiety, the heavy weighted blanket produced significantly greater reductions in broad perceptions of chronic pain than the light weighted blanket (Cohen's f = .19, CI [-1.97, -.91]).","[{'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Baumgartner', 'Affiliation': 'Department of Anesthesiology, University of California San Diego Health, La Jolla, California.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Quintana', 'Affiliation': 'Department of Anesthesiology, University of California San Diego Health, La Jolla, California.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Leija', 'Affiliation': 'Department of Anesthesiology, University of California San Diego Health, La Jolla, California.'}, {'ForeName': 'Nathaniel M', 'Initials': 'NM', 'LastName': 'Schuster', 'Affiliation': 'Department of Anesthesiology, University of California San Diego Health, La Jolla, California.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Bruno', 'Affiliation': 'Department of Anesthesiology, University of California San Diego Health, La Jolla, California.'}, {'ForeName': 'Joel P', 'Initials': 'JP', 'LastName': 'Castellanos', 'Affiliation': 'Department of Anesthesiology, University of California San Diego Health, La Jolla, California.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Case', 'Affiliation': 'Department of Anesthesiology, University of California San Diego Health, La Jolla, California. Electronic address: lcase@health.ucsd.edu.'}]",The journal of pain,['10.1016/j.jpain.2021.07.009']
1650,34432203,"Effect of ""Natural Polypill"", Xuezhikang on Serum Cholesterol Metabolism Markers in Early Menopausal Women with Hypercholesterolemia.","OBJECTIVE


To analyze the effect of Xuezhikang on the markers of the serum lipid levels of cholesterol synthesis and absorption in early menopausal women with hypercholesterolemia, and preliminarily explore its lipid-lowering mechanism.
METHODS


A total of 90 early menopausal women with hypercholesterolemia were enrolled from December, 2014 to May, 2016 from Beijing Anzhen Hospital, Capital Medical University, who were randomly allocated to receive Xuezhikang (1200 mg/d, orally) or atorvastatin (10 mg/d, orally) according to a random number table. Serum levels of some related biomarkers, including cholesterol synthesis markers (squalene, dihydrocholesterol, dehydrocholesterol, and lathosterol), and absorption markers (campesterol, stigmasterol, and sitosterol) as well as safety indices were obtained at baseline and after 8 weeks of the intervention.
RESULTS


Eight weeks after treatment, both Xuezhikang and atorvastatin significantly reduced the levels of total cholesterol, triglycerides, low density cholesterol compared to baseline (all P<0.01). Xuezhikang significantly reduced the levels of squalene, dehydrocholesterol and lathosterol compared to baseline (all P<0.01), but atorvastatin only significantly reduced the level of squalene (P<0.01), compared to baseline. All cholesterol absorption markers showed no significant differences before and after treatment (P>0.05), however, a more obvious downward trend was shown in the Xuezhikang group. In addition, all the safety indices showed no significant differences between the two groups. Although the creatinekinase level in the Xuezhikang group was significantly higher, it remained within the safe range.
CONCLUSIONS


Xuezhikang may have more comprehensive effects on the markers of cholesterol synthesis and metabolism in early menopausal women with hypercholesterolemia through ergosterol and flavonoids in its ""natural polypill.""",2022,"Eight weeks after treatment, both Xuezhikang and atorvastatin significantly reduced the levels of total cholesterol, triglycerides, low density cholesterol compared to baseline (all P<0.01).","['early menopausal women with hypercholesterolemia', 'Early Menopausal Women with Hypercholesterolemia', '90 early menopausal women with hypercholesterolemia were enrolled from December, 2014 to May, 2016 from Beijing Anzhen Hospital, Capital Medical University']","['Xuezhikang', 'atorvastatin', 'Xuezhikang and atorvastatin', 'Natural Polypill"", Xuezhikang']","['cholesterol synthesis markers (squalene, dihydrocholesterol, dehydrocholesterol, and lathosterol), and absorption markers (campesterol, stigmasterol, and sitosterol) as well as safety indices', 'Serum Cholesterol Metabolism Markers', 'levels of squalene, dehydrocholesterol and lathosterol', 'level of squalene', 'All cholesterol absorption markers', 'levels of total cholesterol, triglycerides, low density cholesterol', 'creatinekinase level']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C1566069', 'cui_str': 'xuezhikang'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0205296', 'cui_str': 'Natural'}]","[{'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0038071', 'cui_str': 'Squalene'}, {'cui': 'C0012282', 'cui_str': 'Cholestanol'}, {'cui': 'C0011181', 'cui_str': 'Dehydrocholesterols'}, {'cui': 'C0064673', 'cui_str': 'Lathosterol'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0054560', 'cui_str': 'campesterol'}, {'cui': 'C0038329', 'cui_str': 'Stigmasterol'}, {'cui': 'C0037215', 'cui_str': 'Sitosterols'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",,0.045311,"Eight weeks after treatment, both Xuezhikang and atorvastatin significantly reduced the levels of total cholesterol, triglycerides, low density cholesterol compared to baseline (all P<0.01).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of General Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Shu-Li', 'Initials': 'SL', 'LastName': 'Lu', 'Affiliation': 'Department of General Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Xiang-Gong', 'Initials': 'XG', 'LastName': 'Jin', 'Affiliation': 'Department of General Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of General Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Wan-Pin', 'Initials': 'WP', 'LastName': 'Chen', 'Affiliation': 'Department of General Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Yi-Xin', 'Initials': 'YX', 'LastName': 'Wang', 'Affiliation': 'Department of General Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China. wangyixin6417@sina.com.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Lu-Ya', 'Initials': 'LY', 'LastName': 'Wang', 'Affiliation': 'Department of General Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}]",Chinese journal of integrative medicine,['10.1007/s11655-021-3499-y']
1651,34405965,Adherence to oral therapies among patients with renal cell carcinoma: Post hoc analysis of the ECOG-ACRIN E2805 trial.,"BACKGROUND


As use of oral cancer therapies increases, patient adherence has become critical when evaluating the effectiveness of therapy. In a phase III trial for renal cell carcinoma, we: (a) characterized adherence to sorafenib, sunitinib, and/or placebo and (b) identified factors associated with non-adherence.
METHODS


ECOG-ACRIN E2805 was a double-blind, placebo-controlled, randomized trial comparing adjuvant sorafenib or sunitinib in patients with resected primary renal cell carcinoma at high risk for recurrence. We used patient-completed pill diaries to measure adherence as the number of pills taken divided by the number of pills prescribed. Log-binomial regression was used to identify correlates of non-adherence (<80% of prescribed pills reported as taken).
RESULTS


Mean adherence was 90.7% among those assigned to sunitinib (n = 613) and 84.8% among those assigned to sorafenib (n = 616). Among those assigned to placebo, mean adherence was 94.9% and 92.4% to sunitinib and sorafenib placebo, respectively. Non-adherence was associated with race/ethnicity (non-Hispanic Black: prevalence ratio [PR] 2.22, 95% CI 1.63, 3.01; Hispanic: PR 1.54, 95% CI 1.05, 2.26), high volume enrollment (≥10 patients: PR 1.30, 95% CI 1.03, 1.64), treatment group (sunitinib: PR 2.24, 95% CI 1.66, 3.02; sorafenib: PR 2.37, 95% CI 1.74, 3.22), and skin rash (PR 1.36, 95% CI 1.03, 1.80).
CONCLUSION


Among patients participating in a randomized clinical trial, adherence to oral cancer therapies was lower compared to placebo. Adherence was also worse in racial/ethnic minorities, those experiencing toxicities, and high volume enrolling sites. Our findings highlight several challenges to address in clinical practice as use of oral therapies continues to increase.
CLINICAL TRIAL REGISTRATION NUMBER


This trial is registered with ClinicalTrials.gov, number NCT00326898.",2021,"adherence was associated with race/ethnicity (non-Hispanic Black: prevalence ratio [PR] 2.22, 95% CI 1.63, 3.01; Hispanic: PR 1.54, 95% CI 1.05, 2.26), high volume enrollment (≥10 patients: PR 1.30, 95% CI 1.03, 1.64), treatment group (sunitinib: PR 2.24, 95% CI 1.66, 3.02; sorafenib: PR 2.37, 95% CI 1.74, 3.22), and skin rash (PR 1.36, 95% CI 1.03, 1.80).
","['patients with renal cell carcinoma', 'patients with resected primary renal cell carcinoma at high risk for recurrence']","['sorafenib placebo', 'sunitinib', 'placebo', 'sorafenib', 'adjuvant sorafenib or sunitinib', 'sorafenib, sunitinib, and/or placebo']","['mean adherence', 'Mean adherence', 'skin rash', 'adherence', 'adherence to oral cancer therapies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",,0.535115,"adherence was associated with race/ethnicity (non-Hispanic Black: prevalence ratio [PR] 2.22, 95% CI 1.63, 3.01; Hispanic: PR 1.54, 95% CI 1.05, 2.26), high volume enrollment (≥10 patients: PR 1.30, 95% CI 1.03, 1.64), treatment group (sunitinib: PR 2.24, 95% CI 1.66, 3.02; sorafenib: PR 2.37, 95% CI 1.74, 3.22), and skin rash (PR 1.36, 95% CI 1.03, 1.80).
","[{'ForeName': 'Caitlin C', 'Initials': 'CC', 'LastName': 'Murphy', 'Affiliation': 'School of Public Health, University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Fullington', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Isaac Alex', 'Initials': 'IA', 'LastName': 'Bowman', 'Affiliation': 'Banner MD Anderson Cancer Center, Gilbert, AZ, USA.'}, {'ForeName': 'Maneka', 'Initials': 'M', 'LastName': 'Puligandla', 'Affiliation': 'Department of Data Sciences, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Janice P', 'Initials': 'JP', 'LastName': 'Dutcher', 'Affiliation': 'Cancer Research Foundation of New York, Chappaqua, NY, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'DiPaola', 'Affiliation': 'College of Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Naomi B', 'Initials': 'NB', 'LastName': 'Haas', 'Affiliation': 'Division of Hematology-Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",Cancer medicine,['10.1002/cam4.4140']
1652,34410749,Personalizing interventions using real-world interactions: Improving symptoms and social functioning in schizophrenia with tailored metacognitive therapy.,"OBJECTIVE


When clients' lives are not reflected in therapy, they struggle to apply the skills learned in treatment to everyday situations. In this pilot study, we determined if using clients' real-world interactions in therapy could effectively target metacognitive capacity-yielding improved symptoms and social functioning-by tailoring treatment to focus on issues faced by clients in daily life.
METHOD


Using a randomized controlled trial design, schizophrenia subjects with metacognitive deficits completed 24 sessions of: (a) Standard Metacognitive Reflection and Insight Therapy (MERIT); or (b) Tailored MERIT. Real-world interactions were captured via the Electronically Activated Recorder (EAR), a smartphone application that passively records audio in daily life. All subjects wore the EAR; however, real-world interactions were only used to personalize sessions in Tailored MERIT.
RESULTS


Feasibility and acceptability were shown; those in Tailored MERIT wore the EAR 84% of their waking hours and reported minimal burden. When compared to Standard MERIT, Tailored MERIT participants showed large pre-post reductions in negative metacognitive beliefs and disorganized symptoms. Small, but nonsignificant, improvements in social functioning were also observed.
CONCLUSIONS


Compared to an evidence-based benchmark, we observed that real-world interactions can be used to tailor metacognitive therapy and improve outcomes in schizophrenia. Tailored MERIT has the potential to impact practice by personalizing treatment to account for individual variations in environment and lifestyle-aligning with the Precision Medicine Initiative-in a way that is not possible with current therapy. This is particularly salient in schizophrenia, where limited insight and cognitive deficits often make subjective reporting unreliable. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,"When compared to Standard MERIT, Tailored MERIT participants showed large pre-post reductions in negative metacognitive beliefs and disorganized symptoms.",['schizophrenia subjects with metacognitive deficits completed 24 sessions of: (a'],['Standard Metacognitive Reflection and Insight Therapy (MERIT'],['social functioning'],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",,0.0209132,"When compared to Standard MERIT, Tailored MERIT participants showed large pre-post reductions in negative metacognitive beliefs and disorganized symptoms.","[{'ForeName': 'Kyle S', 'Initials': 'KS', 'LastName': 'Minor', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Marggraf', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Beshaun J', 'Initials': 'BJ', 'LastName': 'Davis', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Mickens', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Danielle B', 'Initials': 'DB', 'LastName': 'Abel', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Robbins', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Buck', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Wiehe', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Lysaker', 'Affiliation': 'Department of Psychiatry.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000672']
1653,34414430,Rate control drugs differ in the prevention of progression of atrial fibrillation.,"AIMS


We hypothesize that in patients with paroxysmal atrial fibrillation (AF), verapamil is associated with lower AF progression compared to beta blockers or no rate control.
METHODS AND RESULTS


In this pre-specified post hoc analysis of the RACE 4 randomized trial, the effect of rate control medication on AF progression in paroxysmal AF was analysed. Patients using Vaughan-Williams Class I or III antiarrhythmic drugs were excluded. The primary outcome was a composite of first electrical cardioversion (ECV), chemical cardioversion (CCV), or atrial ablation. Event rates are displayed using Kaplan-Meier curves and multivariable Cox regression analyses are used to adjust for baseline differences. Out of 666 patients with paroxysmal AF, 47 used verapamil, 383 used beta blockers, and 236 did not use rate control drugs. The verapamil group was significantly younger than the beta blocker group and contained more men than the no rate control group. Over a mean follow-up of 37 months, the primary outcome occurred in 17% in the verapamil group, 33% in the beta blocker group, and 33% in the no rate control group (P = 0.038). After adjusting for baseline characteristics, patients using verapamil have a significantly lower chance of receiving ECV, CCV, or atrial ablation compared to patients using beta blockers [hazard ratio (HR) 0.40, 95% confidence interval (CI) 0.19-0.83] and no rate control (HR 0.64, 95% CI 0.44-0.93).
CONCLUSION


In patients with newly diagnosed paroxysmal AF, verapamil was associated with less AF progression, as compared to beta blockers and no rate control.",2022,"Over a mean follow-up of 37 months, the primary outcome occurred in 17% in the verapamil group, 33% in the beta blocker group, and 33% in the no rate control group (P = 0.038).","['Patients using Vaughan-Williams', '666 patients with paroxysmal AF, 47 used verapamil, 383 used beta blockers, and 236 did not use rate control drugs', 'patients with paroxysmal atrial fibrillation (AF']","['rate control medication', 'verapamil']","['chance of receiving ECV, CCV, or atrial ablation', 'composite of first electrical cardioversion (ECV), chemical cardioversion (CCV), or atrial ablation', 'AF progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0013168', 'cui_str': 'Drug Control'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}]","[{'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C2585199', 'cui_str': 'Chemical cardioversion'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",666.0,0.0920773,"Over a mean follow-up of 37 months, the primary outcome occurred in 17% in the verapamil group, 33% in the beta blocker group, and 33% in the no rate control group (P = 0.038).","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Koldenhof', 'Affiliation': 'Department of Cardiology, Martini Hospital, Van Swietenplein 1, 9728 NT Groningen, The Netherlands.'}, {'ForeName': 'Petra E P J', 'Initials': 'PEPJ', 'LastName': 'Wijtvliet', 'Affiliation': 'Department of Cardiology, Martini Hospital, Van Swietenplein 1, 9728 NT Groningen, The Netherlands.'}, {'ForeName': 'Nikki A H A', 'Initials': 'NAHA', 'LastName': 'Pluymaekers', 'Affiliation': 'Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Rienstra', 'Affiliation': 'Department of Cardiology, University of Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Folkeringa', 'Affiliation': 'Department of Cardiology, Medical Centre Leeuwarden, Henri Dunantweg 2, 8934 AD Leeuwarden, The Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Bronzwaer', 'Affiliation': 'Department of Cardiology, Zaans Medical Centre, Kon. Julianaplein 58, 1502 DV Zaandam, The Netherlands.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Elvan', 'Affiliation': 'Department of Cardiology, Isala Hospital, Dokter van Heesweg 2, 8025 AB Zwolle, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Elders', 'Affiliation': 'Department of Cardiology, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ Nijmegen, The Netherlands.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Tukkie', 'Affiliation': 'Department of Cardiology, Spaarne Hospital, Boerhaavelaan 22, 2035 RC Haarlem, The Netherlands.'}, {'ForeName': 'Justin G L M', 'Initials': 'JGLM', 'LastName': 'Luermans', 'Affiliation': 'Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands.'}, {'ForeName': 'Sander M J', 'Initials': 'SMJ', 'LastName': 'van Kuijk', 'Affiliation': 'Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam University Medical Centre (AMC), Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'van Gelder', 'Affiliation': 'Department of Cardiology, University of Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands.'}, {'ForeName': 'Harry J G M', 'Initials': 'HJGM', 'LastName': 'Crijns', 'Affiliation': 'Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Tieleman', 'Affiliation': 'Department of Cardiology, Martini Hospital, Van Swietenplein 1, 9728 NT Groningen, The Netherlands.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euab191']
1654,34415866,Improving Timeliness of Antibiotic Administration Using a Provider and Pharmacist Facing Sepsis Early Warning System in the Emergency Department Setting: A Randomized Controlled Quality Improvement Initiative.,"OBJECTIVES


Results of pre-post intervention studies of sepsis early warning systems have been mixed, and randomized clinical trials showing efficacy in the emergency department setting are lacking. Additionally, early warning systems can be resource-intensive and may cause unintended consequences such as antibiotic or IV fluid overuse. We assessed the impact of a pharmacist and provider facing sepsis early warning systems on timeliness of antibiotic administration and sepsis-related clinical outcomes in our setting.
DESIGN


A randomized, controlled quality improvement initiative.
SETTING


The main emergency department of an academic, safety-net healthcare system from August to December 2019.
PATIENTS


Adults presenting to the emergency department.
INTERVENTION


Patients were randomized to standard sepsis care or standard care augmented by the display of a sepsis early warning system-triggered flag in the electronic health record combined with electronic health record-based emergency department pharmacist notification.
MEASUREMENTS AND MAIN RESULTS


The primary process measure was time to antibiotic administration from arrival. A total of 598 patients were included in the study over a 5-month period (285 in the intervention group and 313 in the standard care group). Time to antibiotic administration from emergency department arrival was shorter in the augmented care group than that in the standard care group (median, 2.3 hr [interquartile range, 1.4-4.7 hr] vs 3.0 hr [interquartile range, 1.6-5.5 hr]; p = 0.039). The hierarchical composite clinical outcome measure of days alive and out of hospital at 28 days was greater in the augmented care group than that in the standard care group (median, 24.1 vs 22.5 d; p = 0.011). Rates of fluid resuscitation and antibiotic utilization did not differ.
CONCLUSIONS


In this single-center randomized quality improvement initiative, the display of an electronic health record-based sepsis early warning system-triggered flag combined with electronic health record-based pharmacist notification was associated with shorter time to antibiotic administration without an increase in undesirable or potentially harmful clinical interventions.",2022,"The hierarchical composite clinical outcome measure of days alive and out of hospital at 28 days was greater in the augmented care group than that in the standard care group (median, 24.1 vs 22.5 d; p = 0.011).","['A total of 598 patients were included in the study over a 5-month period (285 in the intervention group and 313 in the standard care group', 'The main emergency department of an academic, safety-net healthcare system from August to December 2019', 'Adults presenting to the emergency department']",['standard sepsis care or standard care augmented by the display of a sepsis early warning system-triggered flag in the electronic health record combined with electronic health record-based emergency department pharmacist notification'],"['time to antibiotic administration from arrival', 'Rates of fluid resuscitation and antibiotic utilization', 'Time to antibiotic administration from emergency department arrival', 'days alive and out of hospital at 28 days']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C5200790', 'cui_str': 'Flags'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199779', 'cui_str': 'Administration of antibiotic'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",598.0,0.182226,"The hierarchical composite clinical outcome measure of days alive and out of hospital at 28 days was greater in the augmented care group than that in the standard care group (median, 24.1 vs 22.5 d; p = 0.011).","[{'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Tarabichi', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, MetroHealth Medical Center, Cleveland, OH.'}, {'ForeName': 'Aurelia', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': 'School of Medicine, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bar-Shain', 'Affiliation': 'Center for Clinical Informatics Research and Education, MetroHealth Medical Center, Cleveland, OH.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'McCrate', 'Affiliation': 'Department of Pharmacy, MetroHealth Medical Center, Cleveland, OH.'}, {'ForeName': 'Lewis H', 'Initials': 'LH', 'LastName': 'Reese', 'Affiliation': 'Department of Pharmacy, MetroHealth Medical Center, Cleveland, OH.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Emerman', 'Affiliation': 'School of Medicine, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Siff', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, MetroHealth Medical Center, Cleveland, OH.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Kaelber', 'Affiliation': 'School of Medicine, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Brook', 'Initials': 'B', 'LastName': 'Watts', 'Affiliation': 'School of Medicine, Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Michelle T', 'Initials': 'MT', 'LastName': 'Hecker', 'Affiliation': 'School of Medicine, Case Western Reserve University, Cleveland, OH.'}]",Critical care medicine,['10.1097/CCM.0000000000005267']
1655,34419626,Perioperative subcutaneous methylnaltrexone does not enhance gastrointestinal recovery after posterior short-segment spinal arthrodesis surgery: a randomized controlled trial.,"BACKGROUND CONTEXT


Postoperative ileus is a major barrier to gastrointestinal recovery following surgery. Opioid analgesics likely play an important causative role, particularly in spinal or orthopedic surgeries not involving bowel manipulation. Methylnaltrexone, a peripherally-acting µ-opioid receptor antagonist, is a potential prophylactic treatment.
PURPOSE


To assess the influence of perioperative subcutaneous methylnaltrexone administration on gastrointestinal recovery following short-segment lumbar arthrodesis surgeries.
DESIGN


This is a randomized, double-blind, controlled trial.
PATIENT SAMPLE


Eligible patients undergoing posterior short-segment lumbar arthrodesis surgeries at a single institution between February 2019 and April 2021 were enrolled in this study.
OUTCOME MEASURES


The primary outcome measure was time-to-first bowel movement. Secondary outcome measures included time-to-discharge/discharge eligibility. Exploratory outcome measures included daily postoperative opioid consumption and pain scores.
METHODS


In this study, eligible patients were enrolled to receive either methylnaltrexone or placebo perioperatively. Time-to-bowel movement, time-to-discharge/discharge eligibility, intra and postoperative analgesic administration, and pain scores were recorded and compared.
RESULTS


Eighty two patients in total were enrolled; 41 to the methylnaltrexone and 41 to the placebo group. Both groups were similar in their baseline characteristics. There was no difference in median (range) time-to-bowel movement between the 2 groups [61.8 hours (35.7-93.6) versus 50.7 hours (17.8-110.8), p = .391]. There was also no difference in time-to-discharge/discharge eligibility [105.0 hours (81.0 - 201.3) versus 90.7 (77.5 - 184.5), p=.784]. Finally, there were no differences in either postoperative opioid consumption or numeric rating scores for back, leg, or abdominal pain on postoperative days 0 to 4 (p>.05).
CONCLUSIONS


Methylnaltrexone did not accelerate gastrointestinal recovery and did not affect opioid consumption or pain scores following short-segment spinal surgery as compared to placebo. Additional studies will be needed to identify effective opioid receptor antagonist dosing regimens for patients undergoing either short- or long-segment spinal arthrodesis procedures.",2022,"Finally, there were no differences in either postoperative opioid consumption or numeric rating scores for back, leg, or abdominal pain on postoperative days 0-4 (p > 0.05).
","['SAMPLE\n\n\nEligible patients undergoing posterior short-segment lumbar arthrodesis surgeries at a single institution between February 2019 and April 2021 were enrolled in this study', 'patients undergoing either short- or long-segment spinal arthrodesis procedures', '82 patients in total were enrolled; 41 to the methylnaltrexone and 41 to the placebo group', 'after Posterior Short-Segment Spinal Arthrodesis Surgery', 'eligible patients']","['perioperative subcutaneous methylnaltrexone', 'methylnaltrexone or placebo', 'Perioperative Subcutaneous Methylnaltrexone', 'placebo', 'Methylnaltrexone']","['Gastrointestinal Recovery', 'time-to-discharge/discharge eligibility', 'median (range) time-to-bowel movement', 'opioid consumption or pain scores', 'time-to-first bowel movement', 'Time-to-bowel movement, time-to-discharge/discharge eligibility, intra- and postoperative analgesic administration, and pain scores', 'gastrointestinal recovery', 'daily postoperative opioid consumption and pain scores', 'Postoperative ileus', 'postoperative opioid consumption or numeric rating scores for back, leg, or abdominal pain']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0066411', 'cui_str': 'methylnaltrexone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0066411', 'cui_str': 'methylnaltrexone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",2021.0,0.711021,"Finally, there were no differences in either postoperative opioid consumption or numeric rating scores for back, leg, or abdominal pain on postoperative days 0-4 (p > 0.05).
","[{'ForeName': 'Connor S', 'Initials': 'CS', 'LastName': 'Gifford', 'Affiliation': 'Department of Neurological Surgery, The Ohio State University Wexner Medical Center, 410 W 10th Ave, Columbus, Ohio, USA, 43210.'}, {'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'McGahan', 'Affiliation': 'Department of Neurological Surgery, The Ohio State University Wexner Medical Center, 410 W 10th Ave, Columbus, Ohio, USA, 43210.'}, {'ForeName': 'Shelby D', 'Initials': 'SD', 'LastName': 'Miracle', 'Affiliation': 'Department of Neurological Surgery, The Ohio State University Wexner Medical Center, 410 W 10th Ave, Columbus, Ohio, USA, 43210.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Minnema', 'Affiliation': 'Department of Neurological Surgery, The Ohio State University Wexner Medical Center, 410 W 10th Ave, Columbus, Ohio, USA, 43210.'}, {'ForeName': 'Claire V', 'Initials': 'CV', 'LastName': 'Murphy', 'Affiliation': 'Department of Pharmacy, The Ohio State University Wexner Medical Center, 410 W 10th Ave, Columbus, Ohio, USA, 43210.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Vazquez', 'Affiliation': 'Department of General Surgery, Cleveland Clinic Akron General, 1 Akron General Ave, Akron, Ohio, USA, 44307.'}, {'ForeName': 'Tristan E', 'Initials': 'TE', 'LastName': 'Weaver', 'Affiliation': 'Department of Anesthesiology, The Ohio State University Wexner Medical Center, 410 W 10th Ave, Columbus, Ohio, USA, 43210.'}, {'ForeName': 'H Francis', 'Initials': 'HF', 'LastName': 'Farhadi', 'Affiliation': 'Department of Neurological Surgery, The Ohio State University Wexner Medical Center, 410 W 10th Ave, Columbus, Ohio, USA, 43210. Electronic address: Francis.Farhadi@uky.edu.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2021.08.004']
1656,34426836,Characteristics of patients with atrial high rate episodes detected by implanted defibrillator and resynchronization devices.,"AIMS


Atrial high rate episodes (AHREs) are associated with increased risks of thromboembolism and cardiovascular mortality. However, the clinical characteristics of patients developing AHRE of various durations are not well studied.
METHODS AND RESULTS


This was an ancillary analysis of the multicentre, randomized IMPACT trial. In the present analysis, we classified patients according to the duration of AHRE ≤6 min, >6 min to ≤6 h, >6 to ≤24 h and >24 h, and investigated the association between clinical factors and the development of each duration of AHRE. Of 2718 patients included in the trial, 945 (34.8%) developed AHRE. The incidence rates of each AHRE duration category were 5.4/100, 12.0/100, 6.8/100, and 3.3/100 patient-years, respectively. The incidence rates of AHRE >6 h were significantly higher in patients at high risk of thromboembolism (CHADS2 score ≥3) compared to those at low risk (CHADS2 score 1 or 2). Using Cox regression analysis, age ≥65 years and history of atrial fibrillation (AF) and/or atrial flutter (AFL) were risk factors for AHRE >6 min. In addition, hypertension was associated with AHRE >24 h (hazard ratio 2.13, 95% confidence interval 1.24-3.65, P = 0.006).
CONCLUSION


Atrial high rate episode >6 min to ≤6 h were most prevalent among all AHRE duration categories. Longer AHREs were more common in patients at risk of thromboembolism. Age and history of AF/AFL were risk factors for AHRE >6 min. Furthermore, hypertension showed a strong impact on the development of AHRE >24 h rather than age.",2022,"In addition, hypertension was associated with AHRE >24 h (hazard ratio 2.13, 95% confidence interval 1.24-3.65, P = 0.006).
","['2718 patients included in the trial, 945 (34.8%) developed AHRE']",['implanted defibrillator and resynchronization devices'],"['risks of thromboembolism and cardiovascular mortality', 'history of atrial fibrillation (AF) and/or atrial flutter (AFL', 'incidence rates of each AHRE duration category', 'incidence rates of AHRE >6\u2009h', 'Atrial high rate episode']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0729790', 'cui_str': 'H/O: atrial fibrillation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",2718.0,0.138967,"In addition, hypertension was associated with AHRE >24 h (hazard ratio 2.13, 95% confidence interval 1.24-3.65, P = 0.006).
","[{'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Miyazawa', 'Affiliation': 'Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, 1-8-1 Inohana Chuo-ku, Chiba 260-8677, Japan.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Pastori', 'Affiliation': 'Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Piazzale Aldo Moro, Rome 5 00185, Italy.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Martin', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, 41 Mall Road Burlington, MA 01805, USA.""}, {'ForeName': 'Wassim K', 'Initials': 'WK', 'LastName': 'Choucair', 'Affiliation': 'Heart and Rhythm Institute of South Texas, 8122 Datapoint Dr, San Antonio, TX 78229, USA.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Halperin', 'Affiliation': 'Department of Cardiovascular Diseases, Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, Mount Sinai Heart, 1 Gustave L. Levy Pl, New York, NY 10029, USA.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Thomas Drive, Liverpool L14 3PE, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euab186']
1657,32416645,Alanine Aminotransferase and Gamma-Glutamyl Transpeptidase Predict Histologic Improvement in Pediatric Nonalcoholic Steatohepatitis.,"BACKGROUND AND AIMS


Predictive, noninvasive tools are needed to monitor key features of nonalcoholic fatty liver disease (NAFLD) in children that relate to improvement in liver histology. The purpose of this study was to evaluate the relationship between liver chemistries and liver histology using data from the CyNCh (Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children) clinical trial.
APPROACH AND RESULTS


This study included 146 children. Improvement in liver histology, defined as decrease in nonalcoholic fatty liver disease (NAFLD) Activity Score ≥2 points without worsening of fibrosis, occurred in 43 participants (30%). There were 46 participants with borderline zone 1 nonalcoholic steatohepatitis (NASH) at baseline, with resolution in 28% (12 of 46). Multivariate models were constructed using baseline and change in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT) at 52 weeks, for improvement in (1) liver histology primary outcome, (2) borderline zone 1 NASH, and (3) fibrosis. For improvement in histology, the model (P < 0.0001) retained baseline and change in GGT (area under the receiver operating characteristic [AUROC], 0.79; 95% confidence interval [CI], 0.71-0.87). For borderline zone 1 NASH, the model (P = 0.0004) retained baseline and change in ALT (AUROC, 0.80; 95% CI, 0.67-0.93). For fibrosis, the model (P < 0.001) retained baseline and change in ALT (AUROC, 0.80; 95% CI, 0.67-0.93). Additional clinical parameters were added to the models using Akaike's information criterion selection, and significantly boosted performance: improvement in histology with AUROC of 0.89 (95% CI, 0.82-0.95), borderline zone 1 NASH with AUROC of 0.91 (95% CI, 0.83-0.99), and fibrosis with AUROC of 0.89 (95% CI, 0.82-0.94). Models were validated using data from the TONIC (Treatment of Nonalcoholic Fatty Liver Disease in Children) trial.
CONCLUSIONS


In children with NAFLD, dynamic changes in serum ALT and GGT are associated with change in liver histology and appear to be powerful indicators of histological response.",2021,"Improvement in liver histology, defined as decrease in nonalcoholic fatty liver disease (NAFLD)","['Pediatric Nonalcoholic Steatohepatitis', '146 children', '46 participants with borderline zone 1 nonalcoholic steatohepatitis (NASH) at baseline, with resolution in 28% (12 of 46']",['CyNCh (Cysteamine Bitartrate Delayed-Release'],"['nonalcoholic fatty liver disease (NAFLD', 'alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT', 'Alanine Aminotransferase and Gamma-Glutamyl Transpeptidase Predict Histologic Improvement']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0282119', 'cui_str': 'Cysteamine bitartrate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}]",146.0,0.381863,"Improvement in liver histology, defined as decrease in nonalcoholic fatty liver disease (NAFLD)","[{'ForeName': 'Kimberly P', 'Initials': 'KP', 'LastName': 'Newton', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Lavine', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Columbia University, New York, NY.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Wilson', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Behling', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Miriam B', 'Initials': 'MB', 'LastName': 'Vos', 'Affiliation': ""Department of Pediatrics, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA.""}, {'ForeName': 'Jean P', 'Initials': 'JP', 'LastName': 'Molleston', 'Affiliation': ""Department of Pediatrics, Riley Children's Hospital, Indianapolis, IN.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Rosenthal', 'Affiliation': 'Departments of Pediatrics & Surgery, University of California, San Francisco, CA.'}, {'ForeName': 'Tamir', 'Initials': 'T', 'LastName': 'Miloh', 'Affiliation': ""Department of Pediatrics, Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Fishbein', 'Affiliation': ""Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Jain', 'Affiliation': 'Department of Pediatrics, Saint Louis University, St. Louis, MI.'}, {'ForeName': 'Karen F', 'Initials': 'KF', 'LastName': 'Murray', 'Affiliation': ""Department of Pediatrics, Cleveland Clinic Children's Hospital, Cleveland, OH.""}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Schwimmer', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hepatology (Baltimore, Md.)",['10.1002/hep.31317']
1658,34418398,"Safety and efficacy of bexarotene in patients with relapsing-remitting multiple sclerosis (CCMR One): a randomised, double-blind, placebo-controlled, parallel-group, phase 2a study.","BACKGROUND


Progressive disability in multiple sclerosis occurs because CNS axons degenerate as a late consequence of demyelination. In animals, retinoic acid receptor RXR-gamma agonists promote remyelination. We aimed to assess the safety and efficacy of a non-selective retinoid X receptor agonist in promoting remyelination in people with multiple sclerosis.
METHODS


This randomised, double-blind, placebo-controlled, parallel-group, phase 2a trial (CCMR One) recruited patients with relapsing-remitting multiple sclerosis from two centres in the UK. Eligible participants were aged 18-50 years and had been receiving dimethyl fumarate for at least 6 months. Via a web-based system run by an independent statistician, participants were randomly assigned (1:1), by probability-weighted minimisation using four binary factors, to receive 300 mg/m 2  of body surface area per day of oral bexarotene or oral placebo for 6 months. Participants, investigators, and outcome assessors were masked to treatment allocation. MRI scans were done at baseline and at 6 months. The primary safety outcome was the number of adverse events and withdrawals attributable to bexarotene. The primary efficacy outcome was the patient-level change in mean lesional magnetisation transfer ratio between baseline and month 6 for lesions that had a baseline magnetisation transfer ratio less than the within-patient median. We analysed the primary safety outcome in the safety population, which comprised participants who received at least one dose of their allocated treatment. We analysed the primary efficacy outcome in the intention-to-treat population, which comprised all patients who completed the study. This study is registered in the ISRCTN Registry, 14265371, and has been completed.
FINDINGS


Between Jan 17, 2017, and May 17, 2019, 52 participants were randomly assigned to receive either bexarotene (n=26) or placebo (n=26). Participants who received bexarotene had a higher mean number of adverse events (6·12 [SD 3·09]; 159 events in total) than did participants who received placebo (1·63 [SD 1·50]; 39 events in total). All bexarotene-treated participants had at least one adverse event, which included central hypothyroidism (n=26 vs none on placebo), hypertriglyceridaemia (n=24 vs none on placebo), rash (n=13 vs one on placebo), and neutropenia (n=10 vs none on placebo). Five (19%) participants on bexarotene and two (8%) on placebo discontinued the study drug due to adverse events. One episode of cholecystitis in a placebo-treated participant was the only serious adverse event. The change in mean lesional magnetisation transfer ratio was not different between the bexarotene group (0·25 percentage units [pu; SD 0·98]) and the placebo group (0·09 pu [0·84]; adjusted bexarotene-placebo difference 0·16 pu, 95% CI -0·39 to 0·71; p=0·55).
INTERPRETATION


We do not recommend the use of bexarotene to treat patients with multiple sclerosis because of its poor tolerability and negative primary efficacy outcome. However, statistically significant effects were seen in some exploratory MRI and electrophysiological analyses, suggesting that other retinoid X receptor agonists might have small biological effects that could be investigated in further studies.
FUNDING


Multiple Sclerosis Society of the United Kingdom.",2021,"adjusted bexarotene-placebo difference 0·16 pu, 95% CI -0·39 to 0·71; p=0·55).
","['patients with multiple sclerosis', 'Eligible participants were aged 18-50 years and had been receiving dimethyl fumarate for at least 6 months', 'Between Jan 17, 2017, and May 17, 2019, 52 participants', 'patients with relapsing-remitting multiple sclerosis from two centres in the UK', 'people with multiple sclerosis', 'patients with relapsing-remitting multiple sclerosis (CCMR One', 'treated participants had at least one adverse event, which included central hypothyroidism (n=26 vs none on placebo), hypertriglyceridaemia (n=24 vs none on placebo), rash']","['bexarotene-placebo', 'bexarotene', 'non-selective retinoid X receptor agonist', 'placebo', 'bexarotene or oral placebo']","['serious adverse event', 'neutropenia', 'patient-level change in mean lesional magnetisation transfer ratio', 'safety and efficacy', 'adverse events', 'mean lesional magnetisation transfer ratio', 'Safety and efficacy', 'number of adverse events and withdrawals attributable to bexarotene']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0271801', 'cui_str': 'Central hypothyroidism'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]","[{'cui': 'C0765273', 'cui_str': 'bexarotene'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0140283', 'cui_str': 'Retinoid X Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0765273', 'cui_str': 'bexarotene'}]",52.0,0.850684,"adjusted bexarotene-placebo difference 0·16 pu, 95% CI -0·39 to 0·71; p=0·55).
","[{'ForeName': 'J William L', 'Initials': 'JWL', 'LastName': 'Brown', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK; NMR Research Unit, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology, University College London, London, UK; Clinical Outcomes Research Unit, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Nick G', 'Initials': 'NG', 'LastName': 'Cunniffe', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK. Electronic address: ngc26@cam.ac.uk.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Prados', 'Affiliation': 'NMR Research Unit, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology, University College London, London, UK; Centre for Medical Image Computing, Department of Medical Physics and Biomedical Engineering, University College London, London, UK; e-Health Center, Universitat Oberta de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Kanber', 'Affiliation': 'NMR Research Unit, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology, University College London, London, UK; Centre for Medical Image Computing, Department of Medical Physics and Biomedical Engineering, University College London, London, UK; National Institute for Health Research Biomedical Research Centre, University College London Hospitals NHS Foundation Trust and University College London, London, UK.'}, {'ForeName': 'Joanne L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Needham', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Zoya', 'Initials': 'Z', 'LastName': 'Georgieva', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rog', 'Affiliation': 'Manchester Centre for Clinical Neurosciences, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Owen R', 'Initials': 'OR', 'LastName': 'Pearson', 'Affiliation': 'Department of Neurology, Swansea Bay University Health Board, Swansea, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Overell', 'Affiliation': 'Product Development Neuroscience, F Hoffmann-La Roche, Basel, Switzerland; Institute of Neurological Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'MacManus', 'Affiliation': 'NMR Research Unit, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology, University College London, London, UK.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Samson', 'Affiliation': 'NMR Research Unit, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology, University College London, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Stutters', 'Affiliation': 'NMR Research Unit, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology, University College London, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ffrench-Constant', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Claudia A M', 'Initials': 'CAM', 'LastName': 'Gandini Wheeler-Kingshott', 'Affiliation': 'NMR Research Unit, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology, University College London, London, UK; Brain Connectivity Centre, IRCCS Mondino Foundation, Pavia, Italy; Department of Brain and Behavioural Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Moran', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Flynn', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Michell', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Robin J M', 'Initials': 'RJM', 'LastName': 'Franklin', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK; Wellcome-MRC Cambridge Stem Cell Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Siddharthan', 'Initials': 'S', 'LastName': 'Chandran', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK; UK Dementia Research Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Altmann', 'Affiliation': 'Medical Statistics Department, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Declan T', 'Initials': 'DT', 'LastName': 'Chard', 'Affiliation': 'NMR Research Unit, Queen Square Multiple Sclerosis Centre, UCL Queen Square Institute of Neurology, University College London, London, UK; National Institute for Health Research Biomedical Research Centre, University College London Hospitals NHS Foundation Trust and University College London, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Connick', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Alasdair J', 'Initials': 'AJ', 'LastName': 'Coles', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}]",The Lancet. Neurology,['10.1016/S1474-4422(21)00179-4']
1659,34420834,Long-Term Efficacy and Safety of Zonisamide for Treatment of Parkinsonism in Patients With Dementia With Lewy Bodies: An Open-Label Extension of a Phase three Randomized Controlled Trial.,"OBJECTIVES


To evaluate the long-term efficacy and safety of zonisamide, an antiepileptic agent, in dementia with Lewy bodies (DLB).
DESIGN


Phase three clinical trial with 12 week, randomized, placebo-controlled, double-blind, and subsequent 40 week, open-label, extension periods.
SETTING


A total of 109 centers in Japan between April 2015 and November 2017.
PARTICIPANTS


Outpatients diagnosed with probable DLB.
INTERVENTION


Outpatients were randomly assigned to receive placebo (P) or zonisamide 25 or 50 mg/day for 12 weeks. In the subsequent open-label 40 week period, all patients initially received zonisamide 25 mg/day for at least 2 weeks followed by optional flexible dosing with zonisamide 25 or 50 mg/day for the remaining period.
MEASUREMENTS


The primary outcome was efficacy on motor symptoms, assessed using the Unified Parkinson's Disease Rating Scale part III (UPDRS-III) score, over the total 52 week trial period. Effects on behavioral and psychological symptoms of dementia and cognitive function, and safety were also evaluated.
RESULTS


In total, 335 patients were included in the long-term analysis: 106, 117, and 112 in the P-, 25mg-, and 50mg-Flex groups, respectively. UPDRS-III score continued to improve for an additional 12 to 16 weeks in the open-label period (mean [standard deviation] change from baseline at Week 28: -5.1 [7.3] and -6.3 [8.2] in the 25mg- and 50mg-Flex groups) and remained almost constant thereafter. No unexpected neurological or psychiatric adverse events occurred, and no adverse events increased in incidence in the open-label period.
CONCLUSIONS


Long-term treatment with zonisamide was well tolerated and yielded sustained improvement in motor symptoms.
TRIAL REGISTRATION


JapicCTI-152839 (Registered on 9 March 2015) https://www.clinicaltrials.jp/cti-user/trial/ShowDirect.jsp?japicId=JapicCTI-152839.",2022,"No unexpected neurological or psychiatric adverse events occurred, and no adverse events increased in incidence in the open-label period.
","['335 patients were included in the long-term analysis: 106, 117, and 112 in the P-, 25mg-, and 50mg-Flex groups, respectively', 'A total of 109 centers in Japan between April 2015 and November 2017', 'Patients With Dementia With Lewy Bodies', 'dementia with Lewy bodies (DLB', 'Outpatients diagnosed with probable DLB']","['placebo (P) or zonisamide', 'placebo', 'Zonisamide', 'zonisamide']","[""efficacy on motor symptoms, assessed using the Unified Parkinson's Disease Rating Scale part III (UPDRS-III) score"", 'UPDRS-III score', 'behavioral and psychological symptoms of dementia and cognitive function, and safety', 'neurological or psychiatric adverse events']","[{'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0078844', 'cui_str': 'zonisamide'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",335.0,0.0807137,"No unexpected neurological or psychiatric adverse events occurred, and no adverse events increased in incidence in the open-label period.
","[{'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Odawara', 'Affiliation': 'Health Management Center, Yokohama City University, Kanagawa, Japan (TO).'}, {'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Neurology, National Hospital Organization, Sagamihara National Hospital, Kanagawa, Japan (KH).'}, {'ForeName': 'Ritsuko', 'Initials': 'R', 'LastName': 'Kajiwara', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan (RK, HT, MT).'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Takeuchi', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan (RK, HT, MT).'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Tagawa', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan (RK, HT, MT). Electronic address: masaaki-tagawa@ds-pharma.co.jp.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kosaka', 'Affiliation': 'Shonan Inaho Clinic, Kanagawa, Japan (KK).'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Murata', 'Affiliation': 'Neurology, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan (MM).'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2021.07.002']
1660,34426097,Clinical Trial Protocol for a Randomized Trial of Community Health Worker-led Decision Coaching to Promote Shared Decision-making on Prostate Cancer Screening Among Black Male Patients and Their Providers.,We propose a randomized controlled trial to evaluate the effectiveness of a community health worker-led decision-coaching program to facilitate shared decision-making for prostate cancer screening decisions by Black men at a primary care federally qualified health center.,2021,We propose a randomized controlled trial to evaluate the effectiveness of a community health worker-led decision-coaching program to facilitate shared decision-making for prostate cancer screening decisions by Black men at a primary care federally qualified health center.,"['Black men at a primary care federally qualified health center', 'Black Male Patients and Their Providers']","['Community Health Worker-led Decision Coaching to Promote Shared Decision-making on Prostate Cancer Screening', 'community health worker-led decision-coaching program']",[],"[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.138878,We propose a randomized controlled trial to evaluate the effectiveness of a community health worker-led decision-coaching program to facilitate shared decision-making for prostate cancer screening decisions by Black men at a primary care federally qualified health center.,"[{'ForeName': 'Danil V', 'Initials': 'DV', 'LastName': 'Makarov', 'Affiliation': 'VA New York Harbor Healthcare System, New York, NY, USA; Department of Urology, NYU Langone Health, New York, NY, USA; Department of Population Health, NYU Langone Health, New York, NY, USA. Electronic address: danil.makarov@nyulangone.org.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Ciprut', 'Affiliation': 'VA New York Harbor Healthcare System, New York, NY, USA; Department of Urology, NYU Langone Health, New York, NY, USA; Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Martinez-Lopez', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fagerlin', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Shedlin', 'Affiliation': 'NYU College of Nursing, New York, NY, USA.'}, {'ForeName': 'Heather T', 'Initials': 'HT', 'LastName': 'Gold', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Huilin', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bhat', 'Affiliation': 'Sunset Park Health Council, Brooklyn, New York, NY, USA.'}, {'ForeName': 'Rueben', 'Initials': 'R', 'LastName': 'Warren', 'Affiliation': 'National Center for Bioethics in Research and Health Care, Tuskegee University, Tuskegee, AL, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ubel', 'Affiliation': 'The Fuqua School of Business, Duke University, Durham, NC, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Ravenell', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}]",European urology focus,['10.1016/j.euf.2021.08.001']
1661,34425223,Effect of Empagliflozin Versus Placebo on Body Fluid Balance in Patients With Acute Myocardial Infarction and Type 2 Diabetes Mellitus: Subgroup Analysis of the EMBODY Trial.,"BACKGROUND


The development of heart failure is associated with fluid balance, including that of extracellular water (ECW) and intracellular water (ICW). This study determined whether sodium-glucose cotransporter 2 inhibitors affect fluid balance and improve heart failure in patients after acute myocardial infarction.
METHODS AND RESULTS


EMBODY was a prospective, randomized, double-blinded, placebo-controlled trial of Japanese patients with acute myocardial infarction and type 2 diabetes. Overall, 55 patients who underwent bioelectrical impedance analysis were randomized to receive once daily 10 mg empagliflozin or placebo 2 weeks after acute myocardial infarction onset. We investigated the time course of body fluid balance measured using the bioelectrical impedance analysis device, InBody. The primary end points were changes in body fluid balance from weeks 0 to 24. Changes between baseline and week 24 in the empagliflozin and placebo groups were -0.21 L (P = .127) and +0.40 L (P = .001) in ECW (P = .001) and -0.23 L (P = .264) and +0.74 L (P < .001) in ICW (P < .001), respectively. In a stratified analysis, the rise in ECW and ICW was significantly attenuated in the empagliflozin group in contrast to the placebo group in participants with a body mass index of 25 or higher but not in those with a body mass index of less than 25.
CONCLUSIONS


Early sodium-glucose cotransporter 2 inhibitor administration may attenuate changes in ECW and ICW.",2022,"In a stratified analysis, the rise in ECW and ICW was significantly attenuated in the empagliflozin group in contrast to the placebo group in participants with body mass index ≥25 but not in those with <25 kg/m 2 .
","['55 patients who underwent bioelectrical impedance analysis (BIA', 'patients after acute myocardial infarction (AMI', 'Japanese patients with AMI and type 2 diabetes', 'patients with acute myocardial infarction and type 2 diabetes mellitus']","['sodium-glucose cotransporter 2 (SGLT2) inhibitors', 'BIA device, ""InBody®', 'empagliflozin', 'placebo', 'empagliflozin or placebo']","['rise in ECW and ICW', 'changes in body fluid balance', 'heart failure', 'body fluid balance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",55.0,0.683469,"In a stratified analysis, the rise in ECW and ICW was significantly attenuated in the empagliflozin group in contrast to the placebo group in participants with body mass index ≥25 but not in those with <25 kg/m 2 .
","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hoshika', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Kubota', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan. Electronic address: ykubota@nms.ac.jp.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Mozawa', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Tara', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yukichi', 'Initials': 'Y', 'LastName': 'Tokita', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yodogawa', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yu-Ki', 'Initials': 'YK', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Takano', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yayoi', 'Initials': 'Y', 'LastName': 'Tsukada', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Kuniya', 'Initials': 'K', 'LastName': 'Asai', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Miyauchi', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School Chiba Hokuso, Hospital, Chiba, Japan.'}, {'ForeName': 'Eitaro', 'Initials': 'E', 'LastName': 'Kodani', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School Tama Nagayama, Hospital, Tokyo, Japan.'}, {'ForeName': 'Mitsunori', 'Initials': 'M', 'LastName': 'Maruyama', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School Musashi Kosugi Hospital, Tokyo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tanabe', 'Affiliation': 'Department of Cardiovascular Medicine, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Shimizu', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2021.07.022']
1662,34431993,Risk factors for type 1 and type 2 myocardial infarction.,"AIMS


Whilst the risk factors for type 1 myocardial infarction due to atherosclerotic plaque rupture and thrombosis are established, our understanding of the factors that predispose to type 2 myocardial infarction during acute illness is still emerging. Our aim was to evaluate and compare the risk factors for type 1 and type 2 myocardial infarction.
METHODS AND RESULTS


We conducted a secondary analysis of a multi-centre randomized trial population of 48 282 consecutive patients attending hospital with suspected acute coronary syndrome. The diagnosis of myocardial infarction during the index presentation and all subsequent reattendances was adjudicated according to the Universal Definition of Myocardial Infarction. Cox regression was used to identify predictors of future type 1 and type 2 myocardial infarction during a 1-year follow-up period. Within 1 year, 1331 patients had a subsequent myocardial infarction, with 924 and 407 adjudicated as type 1 and type 2 myocardial infarction, respectively. Risk factors for type 1 and type 2 myocardial infarction were similar, with age, hyperlipidaemia, diabetes, abnormal renal function, and known coronary disease predictors for both (P < 0.05 for all). Whilst women accounted for a greater proportion of patients with type 2 as compared to type 1 myocardial infarction, after adjustment for other risk factors, sex was not a predictor of type 2 myocardial events [adjusted hazard ratio (aHR) 0.82, 95% confidence interval (CI) 0.66-1.01]. The strongest predictor of type 2 myocardial infarction was a prior history of type 2 events (aHR 6.18, 95% CI 4.70-8.12).
CONCLUSIONS


Risk factors for coronary disease that are associated with type 1 myocardial infarction are also important predictors of type 2 events during acute illness. Treatment of these risk factors may reduce future risk of both type 1 and type 2 myocardial infarction.",2022,"Risk factors for type 1 and type 2 myocardial infarction were similar, with age, hyperlipidaemia, diabetes, abnormal renal function, and known coronary disease predictors for both (P < 0.05 for all).","['48 282 consecutive patients attending hospital with suspected acute coronary syndrome', '1331 patients had a subsequent myocardial infarction, with 924 and 407 adjudicated as type 1 and type 2 myocardial infarction, respectively']",[],[],"[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0348593', 'cui_str': 'Subsequent myocardial infarction'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",[],[],48282.0,0.0457234,"Risk factors for type 1 and type 2 myocardial infarction were similar, with age, hyperlipidaemia, diabetes, abnormal renal function, and known coronary disease predictors for both (P < 0.05 for all).","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Wereski', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Chancellors Building, 49 Little France Crescent, Edinburgh EH16 4SA, UK.'}, {'ForeName': 'Dorien M', 'Initials': 'DM', 'LastName': 'Kimenai', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, NINE, 9 Little France Road, Edinburgh BioQuarter, Edinburgh EH16 4UX, UK.'}, {'ForeName': 'Anda', 'Initials': 'A', 'LastName': 'Bularga', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Chancellors Building, 49 Little France Crescent, Edinburgh EH16 4SA, UK.'}, {'ForeName': 'Caelan', 'Initials': 'C', 'LastName': 'Taggart', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Chancellors Building, 49 Little France Crescent, Edinburgh EH16 4SA, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lowe', 'Affiliation': 'University of Glasgow, School of Medicine, Glasgow, UK.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Chancellors Building, 49 Little France Crescent, Edinburgh EH16 4SA, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Chapman', 'Affiliation': 'BHF Centre for Cardiovascular Science, University of Edinburgh, Chancellors Building, 49 Little France Crescent, Edinburgh EH16 4SA, UK.'}]",European heart journal,['10.1093/eurheartj/ehab581']
1663,34429237,"Invited Perspective on the ""Long-Term Efficacy and Safety of Zonisamide for Treatment of Parkinsonism in Patients With Dementia With Lewy Bodies: An Open-label Extension of a Phase 3 Randomized Controlled Trial"".",,2022,,['Patients With Dementia With Lewy Bodies'],['Zonisamide'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}]","[{'cui': 'C0078844', 'cui_str': 'zonisamide'}]",[],,0.11644,,"[{'ForeName': 'Jared T', 'Initials': 'JT', 'LastName': 'Hinkle', 'Affiliation': 'Medical Scientist Training Program, Johns Hopkins University, School of Medicine, Baltimore, MD; Departments of Psychiatry and Neurology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Pontone', 'Affiliation': 'Departments of Psychiatry and Neurology, Johns Hopkins University School of Medicine, Baltimore, MD. Electronic address: gpontone@jhmi.edu.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2021.07.017']
1664,34990262,Polygenic Ara-C Response Score Identifies Pediatric Patients With Acute Myeloid Leukemia in Need of Chemotherapy Augmentation.,"PURPOSE


To establish a patient-specific polygenic score derived from cytarabine (ara-C) pathway pharmacogenomic evaluation to personalize acute myeloid leukemia (AML) treatment.
MATERIALS AND METHODS


Single nucleotide polymorphisms (SNPs) in the ara-C-pathway genes were analyzed with outcome in patients from the multicenter-AML02 trial (N = 166). Multi-SNP predictor modeling was used to develop 10-SNP Ara-C_SNP score (ACS10) using top SNPs predictive of minimal residual disease and event-free survival (EFS) from the AML02-cohort and four SNPs previously associated with ara-C triphosphate levels in the AML97 trial. ACS10 was evaluated for association with outcomes in each clinical trial arms: the standard low-dose ara-C (LDAC, n = 91) and augmented high-dose ara-C (HDAC, n = 75) arms of AML02 and the standard Ara-C, daunorubicin and etoposide (ADE) (n = 465) and the augmented ADE + gemtuzumab ozogamicin (GO; n = 466) arms of AAML0531 trial.
RESULTS


In the standard LDAC-arm of AML02 cohort, the low-ACS10 score group (≤ 0) had significantly worse EFS (ACS10 low  v  high hazard ratio [HR] = 2.81; 95% CI, 1.45 to 5.43;  P  = .002) and overall survival (OS; HR = 2.98; 95% CI, 1.32 to 6.75;  P  = .009) compared with the high-ACS10 group (score > 0). These results were validated in the standard-ADE arm of AAML0531, with poor outcome in the low-ASC10 group compared with the high-ACS10 group (EFS: HR = 1.35, 95% CI, 1.04 to 1.75,  P  = .026; OS: HR = 1.64, 95% CI, 1.2 to 2.22,  P  = .002). Within the augmented arms (AML02-HDAC and AAML0531-ADE + GO), EFS and OS did not differ between low- and high-ACS10 score groups. In both cohorts, patients with low-ACS10 consistently showed a 10-percentage point improvement in 5-year EFS with augmented therapy (AML02-HDAC or AAML0531-ADE + GO arms) than with standard therapy (AML02-LDAC or AAML0531-ADE arms).
CONCLUSION


Patients with low-ACS10 score experienced significantly poor outcome when treated on standard regimen. Augmentation with either high-dose ara-C or GO addition improved outcome in low-ACS10 group. A polygenic ACS10 score can identify patients with unfavorable pharmacogenetic characteristics and offers a potential for an elective augmented therapy option.",2022,"ACS10 low  v  high hazard ratio [HR] = 2.81; 95% CI, 1.45 to 5.43;  P  = .002) and overall survival (OS; HR = 2.98; 95% CI, 1.32 to 6.75;  P  = .009) compared with the high-ACS10 group","['Single nucleotide polymorphisms (SNPs) in the ara-C-pathway genes were analyzed with outcome in patients from the multicenter-AML02 trial (N = 166', 'Pediatric Patients With Acute Myeloid Leukemia in Need of Chemotherapy Augmentation']","['standard low-dose ara-C (LDAC, n = 91) and augmented high-dose ara-C (HDAC, n = 75) arms of AML02 and the standard Ara-C, daunorubicin and etoposide (ADE) (n = 465) and the augmented ADE + gemtuzumab ozogamicin', 'ACS10', 'cytarabine (ara-C']","['5-year EFS', 'overall survival', '10-SNP Ara-C_SNP score (ACS10']","[{'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0019643', 'cui_str': 'Histone Deacetylase'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0876099', 'cui_str': 'Mylotarg'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0325983', 'cui_str': 'Genus Ara'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0916024,"ACS10 low  v  high hazard ratio [HR] = 2.81; 95% CI, 1.45 to 5.43;  P  = .002) and overall survival (OS; HR = 2.98; 95% CI, 1.32 to 6.75;  P  = .009) compared with the high-ACS10 group","[{'ForeName': 'Abdelrahman H', 'Initials': 'AH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL.'}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Acute and Tertiary Care, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Amit K', 'Initials': 'AK', 'LastName': 'Mitra', 'Affiliation': 'Department of Drug Discovery and Development, Harrison School of Pharmacy, Auburn University, Auburn, AL.'}, {'ForeName': 'Huiyun', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Department of Biostatistics, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Raimondi', 'Affiliation': ""Department of Pathology, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cogle', 'Affiliation': 'College of Medicine, University of Florida, Gainesville, FL.'}, {'ForeName': 'Zeina', 'Initials': 'Z', 'LastName': 'Al-Mansour', 'Affiliation': 'College of Medicine, University of Florida, Gainesville, FL.'}, {'ForeName': 'Raul C', 'Initials': 'RC', 'LastName': 'Ribeiro', 'Affiliation': ""Department of Oncology, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Gamis', 'Affiliation': ""Department of Hematology-Oncology, Children's Mercy Hospitals and Clinics, Kansas City, MO.""}, {'ForeName': 'Edward Anders', 'Initials': 'EA', 'LastName': 'Kolb', 'Affiliation': ""Nemours Children's Health, Wilmington, DE.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Aplenc', 'Affiliation': ""Division of Pediatric Oncology/Stem Cell Transplant, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Alonzo', 'Affiliation': 'COG Statistics and Data Center, Monrovia, CA.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Meshinchi', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Rubnitz', 'Affiliation': ""Department of Oncology, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Pounds', 'Affiliation': ""Department of Biostatistics, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Jatinder K', 'Initials': 'JK', 'LastName': 'Lamba', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.01422']
1665,34990581,Edoxaban versus Warfarin in high-risk patients with atrial fibrillation: A comprehensive analysis of high-risk subgroups.,"BACKGROUND


To compare the efficacy and safety of edoxaban vs warfarin in high-risk subgroups.
METHODS


ENGAGE AF-TIMI 48 was a multicenter randomized, double-blind, controlled trial in 21,105 patients with atrial fibrillation (AF) within 12 months and CHADS 2  score >2 randomized to higher-dose edoxaban regimen (HDER) 60 mg/reduced 30 mg, lower-dose edoxaban regimen (LDER) 30 mg/reduced 15 mg, or warfarin, and followed for 2.8 years (median). The primary outcome for this analysis was the net clinical outcome (NCO), a composite of stroke/systemic embolism events, major bleeding, or death. Multivariable risk-stratification analysis was used to categorize patients by the number of high-risk features.
RESULTS


The annualized NCO rates in the warfarin arm were highest in patients with malignancy (19.2%), increased fall risk (14.0%), and very-low body weight (13.5%). The NCO rates increased with the numbers of high-risk factors in the warfarin arm: 4.5%, 7.2%, 9.9% and 14.6% in patients with 0 to 1, 2, 3, and >4 risk factors, respectively (P trend  <0.001). Versus warfarin, HDER was associated with significant reductions of NCO in most of the subgroups: elderly, patients with moderate renal dysfunction, prior stroke/TIA, of Asian race, very-low body weight, concomitant single antiplatelet therapy, and VKA-naïve. With more high-risk features (0->4+), the absolute risk reductions favoring edoxaban over warfarin increased: 0.3%->2.0% for HDER; 0.4%->3.4% for LDER vs warfarin (P = .065 and P < .001, respectively).
CONCLUSIONS


While underuse of anticoagulation in high-risk patients with AF remains common, substitution of effective and safer alternatives to warfarin, such as edoxaban, represents an opportunity to improve clinical outcomes.",2022,"The annualized NCO rates in the warfarin arm were the highest in patients with malignancy (19.2%), increased fall risk (14.0%), and very-low body weight (13.5%).","['21,105 patients with atrial fibrillation (AF) within 12 months and CHADS 2  score >2 randomized to higher-dose', 'High-risk Patients with Atrial Fibrillation', 'high-risk subgroups', 'high-risk patients with AF']","['edoxaban regimen (HDER) 60 mg/reduced 30 mg, lower-dose edoxaban regimen (LDER) 30 mg/reduced 15 mg, or warfarin', 'LDER vs warfarin', 'edoxaban vs. warfarin', 'Edoxaban vs. Warfarin', 'edoxaban']","['annualized NCO rates', 'NCO rates', 'net clinical outcome (NCO), a composite of stroke/systemic embolism events, major bleeding, or death', 'efficacy and safety', 'NCO', 'fall risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0007928', 'cui_str': 'Chad'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}]",21105.0,0.252754,"The annualized NCO rates in the warfarin arm were the highest in patients with malignancy (19.2%), increased fall risk (14.0%), and very-low body weight (13.5%).","[{'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Gencer', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Department of Medicine, Harvard Medical School, Boston, MA; Cardiology Division, Geneva University Hospitals, Geneva, Switzerland; Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.""}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Eisen', 'Affiliation': 'Cardiology Department, Rabin Medical Center, Petah Tikva, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Berger', 'Affiliation': 'Cardiology Department, Rabin Medical Center, Petah Tikva, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Nordio', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Department of Medicine, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Department of Medicine, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Laura T', 'Initials': 'LT', 'LastName': 'Grip', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Department of Medicine, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Daiichi Sankyo Inc , Banking Ridge, NJ.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Lanz', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Munich, Germany.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Department of Medicine, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Department of Medicine, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Department of Medicine, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Department of Medicine, Harvard Medical School, Boston, MA. Electronic address: rgiugliano@bwh.harvard.edu.""}]",American heart journal,['10.1016/j.ahj.2021.12.017']
1666,34424077,Walking Psychotherapy As a Health Promotion Strategy to Improve Mental and Physical Health for Patients and Therapists: Clinical Open-Label Feasibility Trial.,"BACKGROUND


Persons with mental illness are more at risk for sedentary behaviour and associated consequences. We assessed the feasibility of outdoor walking during psychotherapy sessions in an outpatient trauma therapy program to challenge sedentary behaviour.
METHODS


In this pilot trial in Toronto, Canada, female therapists and patients >18 years, were encouraged to walk during 12 consecutive trauma therapy sessions. Both groups were provided wearable pedometers. We assessed protocol feasibility and desirability, and 12-week changes in patient post-traumatic stress [PTSD check-list for DSM-5 (PCL-5)], and depression, anxiety, and stress symptoms [Depression, Anxiety and Stress Scale (DASS)].
RESULTS


91% (20/22) of patients approached for the study consented to participate and 17 (85%) completed follow-up questionnaires. There was walking in 132/197 (67%) of total therapy sessions (mean 7.3 out of 10.9 sessions per participant). Inclement weather was the predominant reason for in-office sessions. At 12-week follow-up, PCL-5 mean scores decreased from 38.4 [standard deviation, ((SD) 11.8) to 30.7 (SD 14.7)], [mean difference (MD) 7.7, 95% CI: 1.5 to 13.8]; 41% (7/17) participants had a clinically significant PCL-5 score reduction of >10 points. DASS-stress mean scores decreased from 19.0 to 16.0 (MD 3.0, 95% CI: 0.3 to 5.6). No changes were observed for DASS depression (MD -0.9, 95% CI: -5.1 to 3.3) nor DASS anxiety (MD -0.2, 95% CI: -3.1 to 2.7). Daily step reporting was inconsistent and not analyzed. There was high acceptability amongst patients and therapists to walk, but not to record daily steps. There were no adverse outcomes.
CONCLUSIONS


It was feasible and acceptable to incorporate outdoor walking during trauma therapy sessions for patients and therapists. Weather was the greatest barrier to implementation. Further randomized-control study to compare seated and walking psychotherapy can clarify if there are psychotherapeutic and physical benefits with walking.",2022,There was walking in 132/197 (67%) of total therapy sessions (mean 7.3 out of 10.9 sessions per participant).,"['Persons with mental illness', 'Toronto, Canada, female therapists and patients >18 years']","['outdoor walking during psychotherapy sessions', 'Walking Psychotherapy', 'seated and walking psychotherapy']","['DASS-stress mean scores', 'patient post-traumatic stress [PTSD check-list for DSM-5 (PCL-5)], and depression, anxiety, and stress symptoms [Depression, Anxiety and Stress Scale (DASS', 'PCL-5 mean scores', 'DASS anxiety', 'DASS depression']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}]",,0.0365458,There was walking in 132/197 (67%) of total therapy sessions (mean 7.3 out of 10.9 sessions per participant).,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Koziel', 'Affiliation': ""7985Women's College Hospital, Toronto, Ontario.""}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Vigod', 'Affiliation': ""7985Women's College Hospital, Toronto, Ontario.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Price', 'Affiliation': ""7985Women's College Hospital, Toronto, Ontario.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Leung', 'Affiliation': ""7985Women's College Hospital, Toronto, Ontario.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hensel', 'Affiliation': '8664University of Manitoba, Winnipeg, Manitoba.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/07067437211039194']
1667,34423904,"A randomized, multicenter trial assessing the effects of rapastinel compared to ketamine, alprazolam, and placebo on simulated driving performance.","N-methyl-D-aspartate ionotropic glutamatergic receptor (NMDAR) modulators, including rapastinel and ketamine, elicit rapid and sustained antidepressant responses in patients with treatment-resistant major depressive disorder. This phase I, randomized, multicenter, placebo-controlled, five-period, crossover, single-dose study evaluated simulated driving performance of healthy participants (N = 107) after single doses of rapastinel slow intravenous (i.v.) bolus 900 and 1800 mg, alprazolam oral 0.75 mg (positive control), ketamine i.v. infusion 0.5 mg/kg (clinical comparator), and placebo ~ 45 min before driving. The primary end point was SD of lateral position (SDLP) during the 60-min 100-km simulated driving scenario. Additional measures of driving performance, sleepiness, and cognition were also evaluated. To assess effects over time, mean SDLP was calculated for each 10-min interval of driving. Sensitivity of the assays was confirmed with alprazolam (all placebo comparisons p < 0.02). Rapastinel 900 and 1800 mg did not significantly affect simulated driving performance compared to placebo (both p > 0.5). Both rapastinel doses resulted in significantly less impaired driving compared to alprazolam or ketamine (all p < 0.002); ketamine significantly impaired driving compared to placebo (p = 0.0001). Results for the additional measures were similar to the primary end point. No new safety signals were observed for any study interventions. This first study of rapastinel effects on simulated driving found that rapastinel 900 and 1800 mg did not impair driving performance, but ketamine 0.5 mg/kg resulted in significantly impaired driving performance. Ketamine's effects on driving were maintained for at least 105 min, indicating that clinicians should be vigilant to prevent or postpone driving in patients after ketamine treatment.",2022,Both rapastinel doses resulted in significantly less impaired driving compared to alprazolam or ketamine (all p<0.002); ketamine significantly impaired driving compared to placebo (p=0.0001).,"['healthy participants (N=107) after single doses of', 'patients with treatment-resistant major depressive disorder']","['Ketamine', 'alprazolam', 'Rapastinel', 'N-methyl-D-aspartate ionotropic glutamatergic receptor (NMDAR) modulators', 'Ketamine, Alprazolam, and Placebo', 'ketamine', 'placebo', 'rapastinel slow intravenous (IV) bolus 900 mg and 1800 mg, alprazolam oral 0.75 mg (positive control), ketamine IV infusion 0.5 mg/kg (clinical comparator), and placebo']","['mean SDLP', 'simulated driving performance', 'driving performance', 'Simulated Driving Performance', 'driving performance, sleepiness, and cognition', 'standard deviation of lateral position (SDLP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C1666271', 'cui_str': 'GLYX-13 peptide'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.131908,Both rapastinel doses resulted in significantly less impaired driving compared to alprazolam or ketamine (all p<0.002); ketamine significantly impaired driving compared to placebo (p=0.0001).,"[{'ForeName': 'Shengfang', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Allergan plc (now AbbVie, Inc.), Madison, New Jersey, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Kay', 'Affiliation': 'Cognitive Research Corporation, St. Petersburg, Florida, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hochadel', 'Affiliation': 'Cognitive Research Corporation, St. Petersburg, Florida, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rojo', 'Affiliation': 'Allergan plc (now AbbVie, Inc.), Madison, New Jersey, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Christopher Stein', 'Affiliation': 'Allergan plc (now AbbVie, Inc.), Madison, New Jersey, USA.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Boinpally', 'Affiliation': 'Clinical Pharmacology, AbbVie, Inc., Madison, New Jersey, USA.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Periclou', 'Affiliation': 'Allergan plc (now AbbVie, Inc.), Madison, New Jersey, USA.'}]",Clinical and translational science,['10.1111/cts.13145']
1668,34422246,Cardiac Ultrasound under Speckle Tracking Technology Based Analysis of Efficacy of Respiratory Rehabilitation on Chronic Obstructive Pulmonary Disease.,"The study shined spotlight on the effect of respiratory rehabilitation training on chronic obstructive pulmonary disease (COPD), which was evaluated using speckle ultrasound algorithm-based cardiac ultrasound. Then, 90 patients with stable COPD, who were admitted to the hospital from January 2018 to December 2019, were randomly rolled into three groups, namely, the fast inhalation and slow exhalation (A) group, abdominal breathing (B) group, and control (C) group. For group A, on the basis of the conventional treatment, the method of rapid inhalation and slow exhalation was adopted. The group B ( n  = 30) adopted the abdominal breathing method besides the conventional treatment. In addition, the group C ( n  = 30) received only conventional treatment. Finally, the efficacy and parameters of the three treatment methods were compared. The echocardiographic parameters and echocardiographic images were calculated and processed by the speckle tracking method. Three kinds of operators were used to track the myocardial spots successfully, and the corresponding points in the image were obtained and calculated. It was found that there was no significant difference in the degree of dyspnea, exercise endurance, lung function, respiratory muscle function, and quality of life (QOL) before treatment ( P  > 0.05). After treatment, in contrast with group C, the previously mentioned indicators in groups A and B were obviously better ( P  < 0.05). Further, both the echocardiographic images and echocardiographic parameters of groups A and B were obviously improved, and there was no obvious difference between groups A and B. Hence, some degree of respiratory rehabilitation was very effective in the diagnosis of patients with chronic pulmonary obstruction. In conclusion, the speckle tracking algorithm-based cardiac ultrasound improves the image quality. At the same time, respiratory rehabilitation training is effective on COPD and worthy of clinical promotion.",2021,"It was found that there was no significant difference in the degree of dyspnea, exercise endurance, lung function, respiratory muscle function, and quality of life (QOL) before treatment ( P  > 0.05).","['90 patients with stable COPD, who were admitted to the hospital from January 2018 to December 2019', 'Chronic Obstructive Pulmonary Disease', 'patients with chronic pulmonary obstruction']","['Cardiac Ultrasound under Speckle Tracking Technology', 'conventional treatment', 'abdominal breathing method besides the conventional treatment', 'respiratory rehabilitation training', 'fast inhalation and slow exhalation (A) group, abdominal breathing (B) group, and control (C) group', 'Respiratory Rehabilitation']","['degree of dyspnea, exercise endurance, lung function, respiratory muscle function, and quality of life (QOL', 'chronic obstructive pulmonary disease (COPD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",90.0,0.0052441,"It was found that there was no significant difference in the degree of dyspnea, exercise endurance, lung function, respiratory muscle function, and quality of life (QOL) before treatment ( P  > 0.05).","[{'ForeName': 'Chuangen', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': 'Department of Ultrasound, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, Zhejiang, China.'}, {'ForeName': 'Wantian', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Ultrasound Medicine, Wenzhou Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medicine University, Wenzhou 325000, Zhejiang, China.'}]",Journal of healthcare engineering,['10.1155/2021/7569908']
1669,34419999,Sleep and Inhibitory Control Over Mood-Congruent Information in Emerging Adults With Depressive Disorder.,"OBJECTIVE


Accumulating evidence has suggested bidirectionality between sleep problems and depression, but the underlying mechanism is unclear. We assessed the role of sleep in inhibitory control ability with emotional stimuli, which has been shown to be suboptimal among individuals with depression and proposed to perpetuate depressive symptoms.
METHODS


Emerging adults (aged 18-25 years, 64.6% female) were screened for depressive and other mental disorders by structured clinical interview and questionnaire. Individuals with depressive disorders were assigned to have a polysomnography-monitored daytime sleep opportunity (Sleep-Dep, n = 20), whereas nondepressed individuals were randomized to either have daytime sleep (Sleep-Ctrl, n = 27) or stay awake (Wake-Ctrl, n = 18). Participants completed the Affective Go/No-Go Task two times, separated by experimental conditions.
RESULTS


A factorial model with a between-subject factor (Sleep-Dep/Sleep-Ctrl/Wake-Ctrl) and a within-subject factor (test 1/test 2) was used to assess if the groups differed in inhibitory control across test sessions, as inferred by changes in d-prime and false alarm rates (FA). Results from mixed factorial models showed a significant interaction effect between time and group on FA in the block with neutral faces as the target and happy faces as the nontarget (F(2,61) = 5.15, pfdr = .045). Although Sleep-Dep had decreased FA after sleep (t(19) = 2.94, pfdr = .050), Sleep-Ctrl and Wake-Ctrl had no significant between-session changes (p values > .05). Postsleep improvement in FA in Sleep-Dep correlated with longer stage 2 sleep (r(20) = 0.788, pfdr < .001) and stage 2 fast spindle number at O1 (r(18) = 0.692, pfdr = .015).
CONCLUSIONS


Sleep gain, particularly stage 2 sleep and related physiology, potentially enhances inhibitory control ability responding to emotional information among individuals with depressive disorders.",2021,"While Sleep-Dep had decreased FA post-sleep, t(19) = 2.94, pfdr = .050, Sleep-Ctrl and Wake-Ctrl had no significant between-session changes, ps > .05.","['individuals with depressive disorders', 'Adults with Depressive Disorder', 'Individuals with depressive disorders', 'Emerging adults (aged 18-25, 64.6% female) were screened for depressive and other mental disorders by structured clinical interview and questionnaire']","['polysomnography-monitored daytime sleep opportunity (Sleep-Dep, N = 20), while non-depressed individuals were randomized to either have daytime sleep (Sleep-Ctrl, N = 27) or stay awake']",['Sleep-Ctrl and Wake-Ctrl'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C4075948', 'cui_str': 'Sleeps during day'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0057472', 'cui_str': '1-(2-(dodecyloxy)ethyl)pyrrolidine hydrochloride'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0234422', 'cui_str': 'Awake'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0442696', 'cui_str': 'Waking'}]",,0.0536759,"While Sleep-Dep had decreased FA post-sleep, t(19) = 2.94, pfdr = .050, Sleep-Ctrl and Wake-Ctrl had no significant between-session changes, ps > .05.","[{'ForeName': 'Esther Yuet Ying', 'Initials': 'EYY', 'LastName': 'Lau', 'Affiliation': 'From the Department of Psychology (E. Lau, Lam), Centre for Psychosocial Health (E. Lau, Lam), and Centre for Religious and Spirituality Education (E. Lau), The Education University of Hong Kong, Hong Kong; Department of Psychology (Wong), University of Exeter, Devon, United Kingdom; Clinical Psychological Services (K. Lau), Hong Kong Children & Youth Services; Department of Psychiatry (Chung, E. Lau), Queen Mary Hospital, The University of Hong Kong, Hong Kong; Departments of Psychiatry (Rusak) and Psychology and Neuroscience (Rusak), Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Mark Lawrence', 'Initials': 'ML', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Yeuk Ching', 'Initials': 'YC', 'LastName': 'Lam', 'Affiliation': ''}, {'ForeName': 'Kristy Nga Ting', 'Initials': 'KNT', 'LastName': 'Lau', 'Affiliation': ''}, {'ForeName': 'Ka Fai', 'Initials': 'KF', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rusak', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000996']
1670,34429364,"Safety and efficacy of tenecteplase versus alteplase in patients with acute ischaemic stroke (TRACE): a multicentre, randomised, open label, blinded-endpoint (PROBE) controlled phase II study.","BACKGROUND


Tenecteplase (TNK) possesses several pharmacological characteristics superior to conventional alteplase (rt-PA), with well-established safety and efficacy profile in Caucasians. There exists controversy over the optimal dose of intravenous rt-PA for East Asians with acute ischaemic stroke (AIS). Current study aimed to determine the safety dose range of recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) for patients with AIS in China.
METHODS


This multicentre, prospective, randomised, open-label, blinded end-point, phase II study compared three tiers of 0.1, 0.25, 0.32 mg/kg rhTNK-tPA (to a maximum of 40 mg) with standard 0.9 mg/kg rt-PA (to a maximum of 90 mg) in patients who were eligible for intravenous thrombolysis. The safety outcome were symptomatic intracranial haemorrhage (sICH) within 36 hours.
RESULTS


Between May 2018 and February 2020, 240 patients were randomly assigned to four group, 4 of whom did not receive study treatment. The intention-to-treat analysis included 236 patients. There was no difference in the improvement on National Institutes of Health Stroke Scale at day 14 in the 3 tiers and control group (63.3%, 77.2%, 66.7% vs 62.7%). The number of sICH was 3 of 60 (5.0%) in the 0.1 mg/kg group, none in the 0.25 mg/kg group, 2 of 60 (3.3%) in the 0.32 mg/kg group and 1 (1.7%) of 59 in the rt-PA group. There were no significant between-group differences in severe adverse events.
CONCLUSIONS


Similar to the Caucasians, rhTNK-tPA was well tolerated in Chinese patients with AIS at all doses administered within 3 hours of symptom onset. The dose-efficacy profile of rhTNK-tPA needs to be established with future investigations.
TRIAL REGISTRATION NUMBER


NCT04676659.",2022,"There was no difference in the improvement on National Institutes of Health Stroke Scale at day 14 in the 3 tiers and control group (63.3%, 77.2%, 66.7% vs 62.7%).","['Between May 2018 and February 2020, 240 patients', 'patients with acute ischaemic stroke (TRACE', 'patients with AIS in China', '236 patients', 'patients who were eligible for intravenous thrombolysis', 'Caucasians', 'East Asians with acute ischaemic stroke (AIS']","['kg rhTNK-tPA', 'tenecteplase versus alteplase', 'intravenous rt-PA', 'Tenecteplase (TNK', 'recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA']","['number of sICH', 'severe adverse events', 'symptomatic intracranial haemorrhage (sICH', 'Safety and efficacy', 'National Institutes of Health Stroke Scale']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",240.0,0.0683729,"There was no difference in the improvement on National Institutes of Health Stroke Scale at day 14 in the 3 tiers and control group (63.3%, 77.2%, 66.7% vs 62.7%).","[{'ForeName': 'Shuya', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Ziran', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Linyi People's Hospital, Linyi, China.""}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Department of Neurology, Affiliated Yantai Yuhuangding Hospital of Qingdao University Medical College, YanTai, China.'}, {'ForeName': 'Huisheng', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, General Hospital of Northern Theatre Command, Shenyang, Liaoning, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Baogang Hospital of Inner Monglia, Inner Monglia, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Sui', 'Affiliation': ""Department of Neurology, The First People's Hospital of Shenyang, Shenyang, China.""}, {'ForeName': 'Xingquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Neurology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Neurology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'WanLiang', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Huaguang', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Neurology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Beijing, China yongjunwang@ncrcnd.org.cn.'}]",Stroke and vascular neurology,['10.1136/svn-2021-000978']
1671,35001863,Three-dimensional versus two-dimensional endoscopes in anatomical orientation of the middle ear and in simulated surgical tasks.,"BACKGROUND


Three-dimensional endoscopes provide a stereoscopic view of the operating field, facilitating depth perception compared to two-dimensional systems, but are not yet widely accepted. Existing research addresses performance and preference, but there are no studies that quantify anatomical orientation in endoscopic ear surgery.
METHODS


Participants (n = 70) were randomised in starting with either the two-dimensional or three-dimensional endoscope system to perform one of two tasks: anatomical orientation using a labelled three-dimensional printed silicone model of the middle ear, or simulated endoscopic skills. Scores and time to task completion were recorded, as well as self-reported difficulty, confidence and preference.
RESULTS


Novice surgeons scored significantly higher in a test of anatomical orientation using three-dimensional compared to two-dimensional endoscopy (p < 0.001), with no significant difference in the speed of simulated endoscopic skills task completion. For both tasks, there was lower self-reported difficulty and increased confidence when using the three-dimensional endoscope. Participants preferred three-dimensional over two-dimensional endoscopy for both tasks.
CONCLUSION


The findings demonstrate the superiority of three-dimensional endoscopy in anatomical orientation, specific to endoscopic ear surgery, with statistically indistinguishable performance in a skills task using a simulated trainer.",2022,"RESULTS


Novice surgeons scored significantly higher in a test of anatomical orientation using three-dimensional compared to two-dimensional endoscopy (p < 0.001), with no significant difference in the speed of simulated endoscopic skills task completion.",['Participants (n = 70'],"['dimensional endoscope system to perform one of two tasks: anatomical orientation using a labelled three-dimensional printed silicone model of the middle ear, or simulated endoscopic skills']","['speed of simulated endoscopic skills task completion', 'Scores and time to task completion']",[],"[{'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",70.0,0.0994149,"RESULTS


Novice surgeons scored significantly higher in a test of anatomical orientation using three-dimensional compared to two-dimensional endoscopy (p < 0.001), with no significant difference in the speed of simulated endoscopic skills task completion.","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Denton', 'Affiliation': 'Postgraduate Centre, University Hospital Monklands, NHS Lanarkshire, Airdrie, Scotland. UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Brahmabhatt', 'Affiliation': 'Department of ENT, Royal Gwent Hospital, Aneurin Bevan University Health Board, Newport, Wales, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ahmed', 'Affiliation': 'Department of ENT, Wrexham Maelor Hospital, Betsi Cadwaladr University Health Board, Wrexham, Wales, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sanu', 'Affiliation': 'Department of ENT, Morriston Hospital, Swansea Bay University Health Board, Wales, UK.'}]",The Journal of laryngology and otology,['10.1017/S002221512200010X']
1672,34431159,"Improving emergency department documentation with noninterruptive clinical decision support: An open-label, randomized clinical efficacy trial.",,2022,"One method of conveying care intricacies is through the use of Current Procedural Terminology (CPT) 1  codes which describe medical procedures, services, and case difficulty for billed patient encounters.",[],[],[],[],[],[],,0.0959777,"One method of conveying care intricacies is through the use of Current Procedural Terminology (CPT) 1  codes which describe medical procedures, services, and case difficulty for billed patient encounters.","[{'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Furmaga', 'Affiliation': 'Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'D Mark', 'Initials': 'DM', 'LastName': 'Courtney', 'Affiliation': 'Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Lehmann', 'Affiliation': 'Clinical Informatics Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Green', 'Affiliation': 'Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': ""O'Connell"", 'Affiliation': 'Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Deborah B', 'Initials': 'DB', 'LastName': 'Diercks', 'Affiliation': 'Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Ott', 'Affiliation': 'University of Texas Southwestern Health System, Dallas, Texas, USA.'}, {'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'McDonald', 'Affiliation': 'Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14379']
1673,34428849,"Quality of Life, Satisfaction, Occlusal Force, and Halitosis after Direct and Indirect Relining of Inferior Complete Dentures.","OBJECTIVE


The aim of this study was to compare the direct relining technique with the indirect relining technique in relation to quality of life, satisfaction with the relining, occlusal force, and halitosis of users of acrylic complete dentures.
MATERIALS AND METHODS


Twenty bimaxillary edentulous individuals were selected. They had to use the same pair of complete dentures for a minimum of 1 year and a maximum of 5 years. The subjects were randomly divided in groups of direct relining and indirect relining of the inferior denture ( n  = 10). Both groups received the same silicone-based relining. The clinical tests verified the quality of life (Oral Health Impact Profile in edentulous individuals), the satisfaction with the relining, the occlusal force, and halitosis. The tests (halitosis and occlusal force) were performed initially (before the relining), immediately after the relining, and 30, 60, 90, and 180 days after the relining. The questionnaires (quality of life and satisfaction with the relining) were performed initially (before the relining), and 30, 60, 90, and 180 days after the relining.
STATISTICAL ANALYSIS


Analysis of variance and the Tukey test were used ( p  < 0.05).
RESULTS


There was no statistical difference comparing the two techniques in all the evaluations ( p  < 0.05). There was a significant statistical difference for the factor of time in all clinical tests for each relining technique ( p  < 0.05). The quality of life and satisfaction with the relining increased significantly 30 days after the relining when compared with the initial time point, for both techniques ( p  < 0.05). The occlusal force increased significantly after 90 and 180 days when compared with the initial time point, for both techniques ( p  < 0.05). Halitosis decreased significantly immediately after the relining when compared with the initial time point, for both techniques ( p  < 0.05).
CONCLUSION


Independent of the relining technique used, there was an increase in the quality of life, satisfaction with the relining, and occlusal force, as well as a reduction in the level of halitosis. Both techniques generated similar results and therefore can be options in clinical practice.",2022,"Independent of the relining technique used, there was an increase in the quality of life, satisfaction with the relining, and occlusal force, as well as a reduction in the level of halitosis.","['in edentulous individuals', 'Twenty bimaxillary edentulous individuals were selected']",['direct relining and indirect relining of the inferior denture'],"['quality of life (Oral Health Impact Profile', 'occlusal force', 'quality of life and satisfaction', 'Halitosis', 'questionnaires (quality of life and satisfaction with the relining', 'Quality of Life, Satisfaction, Occlusal Force, and Halitosis after Direct and Indirect Relining of Inferior Complete Dentures', 'quality of life, satisfaction with the relining, and occlusal force']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0011394', 'cui_str': 'Denture'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018520', 'cui_str': 'Breath smells unpleasant'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}]",,0.0259376,"Independent of the relining technique used, there was an increase in the quality of life, satisfaction with the relining, and occlusal force, as well as a reduction in the level of halitosis.","[{'ForeName': 'Mariana Vilela', 'Initials': 'MV', 'LastName': 'Sônego', 'Affiliation': 'Department of Dental Materials and Prosthodontics, School of Dentistry, São Paulo State University, Araçatuba, São Paulo, Brazil.'}, {'ForeName': 'Clóvis Lamartinede Moraes Melo', 'Initials': 'CLMM', 'LastName': 'Neto', 'Affiliation': 'Department of Dental Materials and Prosthodontics, School of Dentistry, São Paulo State University, Araçatuba, São Paulo, Brazil.'}, {'ForeName': 'Daniela Micheline', 'Initials': 'DM', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Dental Materials and Prosthodontics, School of Dentistry, São Paulo State University, Araçatuba, São Paulo, Brazil.'}, {'ForeName': 'André Luiz de Melo', 'Initials': 'ALM', 'LastName': 'Moreno', 'Affiliation': 'Department of Dental Materials and Prosthodontics, School of Dentistry, São Paulo State University, Araçatuba, São Paulo, Brazil.'}, {'ForeName': 'André Pinheiro de Magalhães', 'Initials': 'APM', 'LastName': 'Bertoz', 'Affiliation': 'Department of Pediatric and Social Dentistry, School of Dentistry, São Paulo State University, Araçatuba, São Paulo, Brazil.'}, {'ForeName': 'Marcelo Coelho', 'Initials': 'MC', 'LastName': 'Goiato', 'Affiliation': 'Department of Dental Materials and Prosthodontics, School of Dentistry, São Paulo State University, Araçatuba, São Paulo, Brazil.'}]",European journal of dentistry,['10.1055/s-0041-1731838']
1674,34426142,A randomized-controlled trial comparing supervised aerobic training to resistance training followed by unsupervised exercise on physical functioning in older breast cancer survivors.,"INTRODUCTION


This study compared the relative efficacy of aerobic training to resistance training on physical functioning in older breast cancer survivors and determined whether benefits could be maintained by transitioning to unsupervised home-based training.
MATERIALS AND METHODS


Early-stage, post-treatment, older (≥65 years) breast cancer survivors (n = 114; mean age 72 years) were randomized to 12 months of supervised aerobic (n = 37), resistance (n = 39) or stretching (active control; n = 38) training followed by 6 months of unsupervised home-based training. Outcomes included aerobic capacity by 6-min walk distance (6MWD; m), maximal upper and lower body strength (1-repetition maximum; kg); physical function by short physical performance battery (SPPB), SF-36 and Late Life Function and Disability Instruments.
RESULTS


Over 12-months of supervised exercise, all groups improved in muscle strength and SPPB scores, but resistance trained women also improved 6MWD. Improvements in upper and lower body strength in the resistance group were significantly greater than those in the stretching control (+2.5 kg vs. +1.8 kg; p = 0.05) and aerobic groups (+8.3 kg vs +2.7 kg; p = 0.047), respectively, with trends for greater improvements in 6MWD (+57.9 m vs. +22.5 m; p = 0.057) and self-report physical function (+4.8 vs. -4.4; 0.066) in resistance trained women versus controls. Compared to values at 12 months, there were no changes during unsupervised training in any measure within or between groups, except for self-reported advanced lower extremity function which improved in the resistance group and fell in the aerobic group (+1.3 vs. -3.1; p = 0.043).
DISCUSSION


Supervised exercise can improve strength and physical functioning among older breast cancer survivors. Resistance training may lead to better improvements compared to aerobic or flexibility training, whether in a supervised or unsupervised setting. Clinicaltrials.govNCT00662103.",2022,"Improvements in upper and lower body strength in the resistance group were significantly greater than those in the stretching control (+2.5 kg vs. +1.8 kg; p = 0.05) and aerobic groups (+8.3 kg vs +2.7 kg; p = 0.047), respectively, with trends for greater improvements in 6MWD (+57.9 m vs. +22.5 m; p = 0.057) and self-report physical function (+4.8 vs. -4.4; 0.066) in resistance trained women versus controls.","['114; mean age 72\xa0years', 'older breast cancer survivors', 'Early-stage, post-treatment, older (≥65\xa0years) breast cancer survivors (n\xa0']","['Supervised exercise', 'Resistance training', 'supervised aerobic training to resistance training followed by unsupervised exercise', 'aerobic training to resistance training', 'supervised aerobic (n\xa0=\xa037), resistance (n\xa0=\xa039) or stretching (active control; n\xa0=\xa038) training followed by 6\xa0months of unsupervised home-based training']","['strength and physical functioning', 'aerobic capacity by 6-min walk distance (6MWD; m), maximal upper and lower body strength (1-repetition maximum; kg); physical function by short physical performance battery (SPPB), SF-36 and Late Life Function and Disability Instruments', 'muscle strength and SPPB scores', 'self-report physical function', 'Improvements in upper and lower body strength', '6MWD', 'advanced lower extremity function']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",114.0,0.0247876,"Improvements in upper and lower body strength in the resistance group were significantly greater than those in the stretching control (+2.5 kg vs. +1.8 kg; p = 0.05) and aerobic groups (+8.3 kg vs +2.7 kg; p = 0.047), respectively, with trends for greater improvements in 6MWD (+57.9 m vs. +22.5 m; p = 0.057) and self-report physical function (+4.8 vs. -4.4; 0.066) in resistance trained women versus controls.","[{'ForeName': 'Kerri M', 'Initials': 'KM', 'LastName': 'Winters-Stone', 'Affiliation': 'School of Nursing, Oregon Health & Science University, Portland, OR, United States of America; Knight Cancer Institute, Oregon Health & Science University, Portland, OR, United States of America. Electronic address: wintersk@ohsu.edu.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Torgrimson-Ojerio', 'Affiliation': 'The Center for Health Research, Kaiser Permanente Northwest, Portland, OR, United States of America.'}, {'ForeName': 'Nathan F', 'Initials': 'NF', 'LastName': 'Dieckmann', 'Affiliation': 'School of Nursing, Oregon Health & Science University, Portland, OR, United States of America; School of Medicine, Division of Psychology, Oregon Health & Science University, Portland, OR, United States of America.'}, {'ForeName': 'Sydnee', 'Initials': 'S', 'LastName': 'Stoyles', 'Affiliation': 'School of Nursing, Oregon Health & Science University, Portland, OR, United States of America.'}, {'ForeName': 'Zahi', 'Initials': 'Z', 'LastName': 'Mitri', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, OR, United States of America.'}, {'ForeName': 'Shiuh-Wen', 'Initials': 'SW', 'LastName': 'Luoh', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, OR, United States of America; VA Portland Health Care System, Portland, OR, United States of America.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2021.08.003']
1675,35063948,Response to: 'Comment on 'Direct swallowing training and oral sensorimotor stimulation in preterm infants: a randomised controlled trial' by Heo  et al'  by Harding  et al .,,2022,,['preterm infants'],['Direct swallowing training and oral sensorimotor stimulation'],[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",[],,0.0646604,,"[{'ForeName': 'Ju Sun', 'Initials': 'JS', 'LastName': 'Heo', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Ee-Kyung', 'Initials': 'EK', 'LastName': 'Kim', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, The Republic of Korea kimek@snu.ac.kr.'}, {'ForeName': 'Sae Yun', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'In Gyu', 'Initials': 'IG', 'LastName': 'Song', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Young Mi', 'Initials': 'YM', 'LastName': 'Yoon', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Eun Sun', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Seung Han', 'Initials': 'SH', 'LastName': 'Shin', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Byung-Mo', 'Initials': 'BM', 'LastName': 'Oh', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Hyung Ik', 'Initials': 'HI', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Han-Suk', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Paediatrics, Seoul National University College of Medicine, Seoul, The Republic of Korea.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2021-323580']
1676,35038568,The use of virtual reality to modify and personalize interior home features in Parkinson's disease.,"As the second most common progressive neurodegenerative disorder with increased prevalence in the aging population, Parkinson's disease (PD) affects more than 10 million individuals worldwide with approximately 60,000 new cases occurring each year only in the US. While daily living abilities deteriorate in people with PD, they spend a significant amount of time in their homes. Unfortunately, most existing guidelines for home modification design reflect a standardized, singular plan. This study aimed to demonstrate the feasibility of using a virtual reality (VR) system for persons with PD to virtually walk through different home modifications and to adapt and personalize interior features. A sample of 15 participants with idiopathic PD and 24 healthy adults ambulated on a pressure mat, while using a VR headset and hand controller. Both groups envisioned walking through a virtual doorway from a simulated bedroom into its attached bathroom. Design features for the intervention included doorway width and door-frame color. Each participant was randomly assigned to one of three intervention conditions: (1) standard design, (2) enhanced design, and (3) co-design. The codesign module allowed participants to manipulate design features using a hand controller. We recorded 4 movement variables. Participants completed three questionnaires assessing anxiety, system usability, and satisfaction. Healthy control adults revealed no differences in movement or subjective assessment between the three intervention conditions. However, there were significant differences in the PD group between co-design and the other conditions. The changes were appreciated in the baseline measures of gait distance and strikes as well as in the composite gait component score. This study showed that using VR as a participatory design tool for persons with PD is safe and feasible. Additionally, the self-determination of interior design conditions may possibly affect movement performance measures and merits additional controlled trials.",2022,The changes were appreciated in the baseline measures of gait distance and strikes as well as in the composite gait component score.,"[""Parkinson's disease"", 'persons with PD', 'Healthy control adults', 'people with PD', '15 participants with idiopathic PD and 24 healthy adults ambulated on a pressure mat, while using a VR headset and hand controller']",['virtual reality (VR) system'],"['questionnaires assessing anxiety, system usability, and satisfaction', 'movement or subjective assessment', 'doorway width and door-frame color', 'gait distance and strikes as well as in the composite gait component score']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0557692', 'cui_str': 'Doorway'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",15.0,0.105196,The changes were appreciated in the baseline measures of gait distance and strikes as well as in the composite gait component score.,"[{'ForeName': 'Shabboo', 'Initials': 'S', 'LastName': 'Valipoor', 'Affiliation': 'Department of Interior Design, College of Design, Construction and Planning, University of Florida, Gainesville, FL, USA. Electronic address: sh.valipoor@ufl.edu.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Ahrentzen', 'Affiliation': 'Shimberg Center for Housing Studies, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Srinivasan', 'Affiliation': 'Rinker School of Construction Management, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Akiely', 'Affiliation': 'Department of Urban and Regional Planning, College of Design, Construction and Planning, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Jithin', 'Initials': 'J', 'LastName': 'Gopinadhan', 'Affiliation': 'Rinker School of Construction Management, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Okun', 'Affiliation': 'Department of Neurology, University of Florida, Gainesville, FL, USA; Norman Fixel Institute for Neurological Diseases, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Ramirez-Zamora', 'Affiliation': 'Department of Neurology, University of Florida, Gainesville, FL, USA; Norman Fixel Institute for Neurological Diseases, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Aparna A', 'Initials': 'AA', 'LastName': 'Wagle Shukla', 'Affiliation': 'Department of Neurology, University of Florida, Gainesville, FL, USA.'}]",Experimental gerontology,['10.1016/j.exger.2022.111702']
1677,35069447,"Decrease in Salivary Serotonin in Response to Probiotic Supplementation With  Saccharomyces boulardii  in Healthy Volunteers Under Psychological Stress: Secondary Analysis of a Randomized, Double-Blind, Placebo-Controlled Trial.","Background


Bacterial probiotics are thought to exert a serotonergic effect relevant to their potential antidepressant and pro-cognitive action, but yeast probiotics have not been tested. The aim of the present study was to determine whether 30-day supplementation with  Saccharomyces boulardii  affects the level of salivary serotonin under psychological stress and identify the factors associated with it.
Methods


Healthy medical students were randomized to ingest  Saccharomyces boulardii  CNCM I-1079 or placebo before a stressful event. Salivary serotonin concentration was assessed before and at the end of supplementation. Moreover, obtained results were compared to psychological, biochemical, physiological and sociodemographic study participants data.
Results


Data of thirty-two participants (22.8 ± 1.7 years of age, 16 males) was available for the main analysis. Supplementation with  Saccharomyces boulardii  decreased salivary serotonin concentration under psychological stress by 3.13 (95% CI 0.20 to 6.07) ng/mL,  p  = 0.037, as compared to placebo. Salivary serotonin was positively correlated with salivary metanephrine (β = 0.27, 95% CI 0.02 to 0.52,  p  = 0.031) and pulse rate (β = 0.28, 95% CI 0.05 to 0.50,  p  = 0.018), but insignificantly with anxiety, depression, eating attitudes and information retrieval.
Conclusions


Saccharomyces boulardii  CNCM I-1079 may be distinct from bacterial probiotics in its salivary serotonergic effect, which appears positively linked to symapathoadrenal markers. The study requires cautious interpretation, and further investigation.",2021,"Supplementation with  Saccharomyces boulardii  decreased salivary serotonin concentration under psychological stress by 3.13 (95% CI 0.20 to 6.07) ng/mL,  p  = 0.037, as compared to placebo.","['Methods\n\n\nHealthy medical students', 'Under Psychological Stress', 'thirty-two participants (22.8 ± 1.7 years of age, 16 males', 'Healthy Volunteers']","['ingest  Saccharomyces boulardii  CNCM I-1079 or placebo', 'Placebo', 'Saccharomyces boulardii']","['Salivary serotonin', 'pulse rate', 'anxiety, depression, eating attitudes and information retrieval', 'salivary serotonin concentration under psychological stress', 'Salivary serotonin concentration', 'salivary metanephrine']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0772093', 'cui_str': 'Saccharomyces boulardii'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0021427', 'cui_str': 'Information Storage and Retrieval'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0025562', 'cui_str': 'Metanephrine'}]",,0.494336,"Supplementation with  Saccharomyces boulardii  decreased salivary serotonin concentration under psychological stress by 3.13 (95% CI 0.20 to 6.07) ng/mL,  p  = 0.037, as compared to placebo.","[{'ForeName': 'Michał Seweryn', 'Initials': 'MS', 'LastName': 'Karbownik', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Lodz, Łódź, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Kręczyńska', 'Affiliation': 'Department of Infectious Diseases and Hepatology, Medical University of Lodz, Łódź, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wiktorowska-Owczarek', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Lodz, Łódź, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Kwarta', 'Affiliation': 'Psychiatric Ward for Adolescents, Babinski Specialist Psychiatric Healthcare Center, Łódź, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Cybula', 'Affiliation': 'Oklahoma Medical Research Foundation, Aging and Metabolism Program, Oklahoma City, OK, United States.'}, {'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Stilinović', 'Affiliation': 'Department of Pharmacology, Toxicology and Clinical Pharmacology, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Pietras', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Lodz, Łódź, Poland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Kowalczyk', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Lodz, Łódź, Poland.'}]",Frontiers in endocrinology,['10.3389/fendo.2021.800023']
1678,34921023,A Randomized Phase II Study Comparing Nivolumab with Carboplatin-Pemetrexed for EGFR-Mutated NSCLC with Resistance to EGFR Tyrosine Kinase Inhibitors (WJOG8515L).,"PURPOSE


Although the efficacy of programmed cell death-1 (PD-1) blockade is generally poor for non-small cell lung cancer (NSCLC) with activating mutations of the epidermal growth factor receptor (EGFR) gene, EGFR tyrosine kinase inhibitors (TKIs) may improve the tumor immune microenvironment. We performed a randomized study to assess whether nivolumab improves outcome compared with chemotherapy in such patients previously treated with EGFR-TKIs.
PATIENTS AND METHODS


Patients with EGFR-mutated NSCLC who acquired EGFR-TKI resistance not due to a secondary T790M mutation of EGFR were randomized 1:1 to nivolumab (n = 52) or carboplatin-pemetrexed (n = 50). The primary endpoint was progression-free survival (PFS).
RESULTS


Median PFS and 1-year PFS probability were 1.7 months and 9.6% for nivolumab versus 5.6 months and 14.0% for carboplatin-pemetrexed [log-rank P < 001; hazard ratio (HR) of 1.92, with a 60% confidence interval (CI) of 1.61-2.29]. Overall survival was 20.7 and 19.9 months [HR, 0.88 (95% CI, 0.53-1.47)], and response rate was 9.6% and 36.0% for nivolumab and carboplatin-pemetrexed, respectively. No subgroup including patients with a high tumor mutation burden showed a substantially longer PFS with nivolumab than with carboplatin-pemetrexed. The T-cell-inflamed gene expression profile score (0.11 vs. -0.17, P = 0.036) and expression of genes related to cytotoxic T lymphocytes or their recruitment were higher in tumors that showed a benefit from nivolumab.
CONCLUSIONS


Nivolumab did not confer a longer PFS compared with carboplatin-pemetrexed in the study patients. Gene expression profiling identified some cases with a favorable tumor immune microenvironment that was associated with nivolumab efficacy.",2022,"The T-cell-inflamed gene expression profile score (0.11 vs. -0.17,  P  = 0.036) and expression of genes related to cytotoxic T lymphocytes or their recruitment were higher in tumors that showed a benefit from nivolumab.
","['Patients with  EGFR -mutated NSCLC who acquired EGFR-TKI resistance not due to a secondary T790M mutation of', 'patients previously treated with EGFR-TKIs']","['chemotherapy', 'nivolumab', 'programmed cell death-1 (PD-1) blockade', 'carboplatin-pemetrexed', 'Nivolumab with Carboplatin-Pemetrexed']","['progression-free survival (PFS', 'T-cell-inflamed gene expression profile score', 'Overall survival', 'Median PFS and 1-year PFS probability', 'response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C1449575', 'cui_str': 'Microarray Analysis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.25263,"The T-cell-inflamed gene expression profile score (0.11 vs. -0.17,  P  = 0.036) and expression of genes related to cytotoxic T lymphocytes or their recruitment were higher in tumors that showed a benefit from nivolumab.
","[{'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Aoba-ku, Sendai, Miyagi, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Fukuda', 'Affiliation': 'Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Chuo-ku, Kobe, Hyogo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Miura', 'Affiliation': 'Department of Internal Medicine, Niigata Cancer Center Hospital, Chuo-ku, Niigata, Niigata, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Ota', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Higashi-ku, Fukuoka, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Ozawa', 'Affiliation': 'Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hara', 'Affiliation': 'Department of Respiratory Medicine, Itami City Hospital, Itami, Hyogo, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Tanizaki', 'Affiliation': 'Department of Medical Oncology, Kishiwada City Hospital, Kishiwada, Osaka, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Azuma', 'Affiliation': 'Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Omori', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Tachihara', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Chuo-ku, Kobe, Hyogo, Japan.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Nishino', 'Affiliation': 'Department of Thoracic Oncology, Osaka International Cancer Institute, Chuo-ku, Osaka, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Bessho', 'Affiliation': 'Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Kita-ku, Okayama, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Chiba', 'Affiliation': 'Clinical Research Center, Kindai University Hospital, Osaka-Sayama, Osaka, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Haratani', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.'}, {'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Sakai', 'Affiliation': 'Department of Genome Biology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.'}, {'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Nishio', 'Affiliation': 'Department of Genome Biology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-3194']
1679,35032664,A social worker intervention to reduce post-hospital mortality in HIV-infected adults in Tanzania (Daraja): Study protocol for a randomized controlled trial.,"BACKGROUND


In sub-Saharan Africa (SSA), hospitalized HIV-infected patients who are discharged home have been shown to experience extremely high mortality rate. Daraja is an individual-level, time-limited, five-session case management intervention aiming to link hospitalized HIV-infected patients to outpatient HIV care upon discharge.
METHODS


A randomized control trial will aim at evaluating the efficacy of Daraja intervention on reducing mortality in hospitalized HIV-infected patients upon discharge from hospital. The study will recruit 500 hospitalized HIV-infected adults who are ART naïve or defaulted for >7 days from hospitals in Mwanza region, Tanzania. Participants will be enrolled during hospitalization and a baseline assessment will be done. Participants will be randomized to receive either the standard of care HIV linkage, or the Daraja intervention a day before the expected hospital discharge date. The Daraja intervention includes five sessions delivered by a social worker over a 3-month period. All participants will complete follow-up assessment at month 12 and 24. Measures will include 1-year survival, HIV care continuum outcomes (linkage, retention, antiretroviral adherence, and viral suppression), and cost (incremental cost of the intervention and cost per life saved). Quality assurance data will be collected, and the feasibility and acceptability of the intervention will be described. Statistical analysis will assess the effectiveness of the Daraja intervention on improving survival and HIV care continuum outcomes.
DISCUSSION


Hospitalized HIV-infected patients who are being discharged home have higher mortality due to poor linkage to primary HIV care. The Daraja intervention has the potential to address barriers that prevent successful transition from hospital to primary HIV care.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03858998. Registered on 01 March 2019.",2022,"Daraja is an individual-level, time-limited, five-session case management intervention aiming to link hospitalized HIV-infected patients to outpatient HIV care upon discharge.
","['500 hospitalized HIV-infected adults who are ART naïve or defaulted for >7\xa0days from hospitals in Mwanza region, Tanzania', 'HIV-infected adults in Tanzania (Daraja', 'hospitalized HIV-infected patients upon discharge from hospital']","['Daraja intervention', 'social worker intervention']","['mortality', '1-year survival, HIV care continuum outcomes (linkage, retention, antiretroviral adherence, and viral suppression), and cost (incremental cost of the intervention and cost per life saved']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",500.0,0.266418,"Daraja is an individual-level, time-limited, five-session case management intervention aiming to link hospitalized HIV-infected patients to outpatient HIV care upon discharge.
","[{'ForeName': 'Godfrey A', 'Initials': 'GA', 'LastName': 'Kisigo', 'Affiliation': 'Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania; Center for Global Health, Weill Cornell Medicine, 1300 York Avenue, New York, NY 10065, United States of America. Electronic address: godfrey.kisigo@mitu.or.tz.'}, {'ForeName': 'Benson', 'Initials': 'B', 'LastName': 'Issarow', 'Affiliation': 'Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania. Electronic address: benson.issarow@mitu.or.tz.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Abel', 'Affiliation': 'Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania. Electronic address: kelvin.peter@mitu.or.tz.'}, {'ForeName': 'Ramadhan', 'Initials': 'R', 'LastName': 'Hashim', 'Affiliation': 'Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania. Electronic address: ramadhan.hashim@mitu.or.tz.'}, {'ForeName': 'Elialilia S', 'Initials': 'ES', 'LastName': 'Okello', 'Affiliation': 'Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania. Electronic address: elialilia.okello@mitu.or.tz.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ayieko', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Department of Infectious Disease Epidemiology, Keppel Street, London WC1E 7HT, UK. Electronic address: philip.Ayieko@lshtm.ac.uk.'}, {'ForeName': 'Myung Hee', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania. Electronic address: myl2003@med.cornell.edu.'}, {'ForeName': 'Heiner', 'Initials': 'H', 'LastName': 'Grosskurth', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Department of Infectious Disease Epidemiology, Keppel Street, London WC1E 7HT, UK. Electronic address: heiner.Grosskurth@lshtm.ac.uk.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fitzgerald', 'Affiliation': 'Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania. Electronic address: dwf2001@med.cornell.edu.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Peck', 'Affiliation': 'Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania; Center for Global Health, Weill Cornell Medicine, 1300 York Avenue, New York, NY 10065, United States of America. Electronic address: rnp2002@med.cornell.edu.'}, {'ForeName': 'Saidi', 'Initials': 'S', 'LastName': 'Kapiga', 'Affiliation': 'Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania; London School of Hygiene and Tropical Medicine, Department of Infectious Disease Epidemiology, Keppel Street, London WC1E 7HT, UK. Electronic address: saidi.Kapiga@LSHTM.ac.uk.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106680']
1680,35063281,Randomized phase II trial of weekly paclitaxel vs. cediranib-olaparib (continuous or intermittent schedule) in platinum-resistant high-grade epithelial ovarian cancer.,"BACKGROUND


Previous findings showed that cediranib-olaparib increased PFS in women with recurrent platinum-sensitive ovarian cancer compared to olaparib alone.
METHODS


BAROCCO trial randomized 123 patients: 80mg/m2 paclitaxel weekly up to 24 weeks (control), olaparib 300mg tablets twice daily together with 20mg cediranib daily (continuous schedule) or with 20mg cediranib 5 days/week (intermittent schedule) until progression. The primary objective was the PFS comparison between each experimental arm and the control (alpha one-sided 5%; power 80%; HR 0.5).
RESULTS


The median platinum-free interval was 1.9 months, 60% of patients had been pretreated with 3 or more chemotherapy lines. Median PFS for paclitaxel, the continuous, and the intermittent schedules were 3.1, 5.6, and 3.8 months. The HR for PFS in the continuous arm vs control was 0.76 (90% CI: 0.50-1.14, p = 0.265). The HR for PFS in the intermittent arm vs control was 1.03 (90% CI: 0.68-1.55, p = 0.904). Treatment was discontinued due to adverse events in 15%, 20%, and 5% of patients in the control, continuous and intermittent arms. Grade ≥ 3 anemia and diarrhea and hypertension of any grade occurred only in the experimental arms, and peripheral neuropathies and alopecia only in the control arm. Five serious adverse drug reactions occurred and two were fatal: one in the control and one in the continuous arm.
CONCLUSIONS


The combination of cediranib-olaparib was not superior to chemotherapy in terms of PFS in heavily pretreated platinum-resistant ovarian cancer patients. However, this oral doublet, is active and may offer a non-chemotherapy option in this difficult to treat population.
CLINICAL TRIAL IDENTIFICATION


IRFMN-OVA-7289, EudraCT: 2016-003964-38, NCT03314740.",2022,"Median PFS for paclitaxel, the continuous, and the intermittent schedules were 3.1, 5.6, and 3.8 months.","['women with recurrent platinum-sensitive ovarian cancer', 'heavily pretreated platinum-resistant ovarian cancer patients', 'platinum-resistant high-grade epithelial ovarian cancer', '123 patients']","['olaparib 300mg tablets twice daily together with 20mg cediranib', 'EudraCT', 'cediranib-olaparib', 'paclitaxel vs. cediranib-olaparib (continuous or intermittent schedule']","['Grade\xa0≥\xa03 anemia and diarrhea and hypertension of any grade', 'peripheral neuropathies and alopecia', 'HR for PFS', 'PFS', 'median platinum-free interval', 'adverse events', 'Median PFS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1698364', 'cui_str': 'cediranib'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",123.0,0.0680043,"Median PFS for paclitaxel, the continuous, and the intermittent schedules were 3.1, 5.6, and 3.8 months.","[{'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'European Institute of Oncology, IRCCS, Milan, Italy; University of Milan-Bicocca, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Tomao', 'Affiliation': 'European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Benedetti Panici', 'Affiliation': 'Università Sapienza, Dipartimento Materno Infantile e Scienze Urologiche, AOU Policlinico Umberto I di Roma, Italy.'}, {'ForeName': 'Maria Ornella', 'Initials': 'MO', 'LastName': 'Nicoletto', 'Affiliation': 'Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.'}, {'ForeName': 'Germana', 'Initials': 'G', 'LastName': 'Tognon', 'Affiliation': 'ASST Spedali Civili-Università degli Studi di Brescia, Brescia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bologna', 'Affiliation': 'Azienda Unità Sanitaria Locale di Reggio Emilia-IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Andrea Alberto', 'Initials': 'AA', 'LastName': 'Lissoni', 'Affiliation': 'Clinica Ostetrica e Ginecologica - Ospedale S.Gerardo di Monza, Milano, Italy; University of Milan-Bicocca, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'DeCensi', 'Affiliation': 'Department of Medicine, Ospedali Galliera, Genova, Italy.'}, {'ForeName': 'Mariateresa', 'Initials': 'M', 'LastName': 'Lapresa', 'Affiliation': 'European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Mancari', 'Affiliation': 'European Institute of Oncology, IRCCS, Milan, Italy; Gynecologic Oncology Unit, IRCCS-Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Innocenza', 'Initials': 'I', 'LastName': 'Palaia', 'Affiliation': 'Università Sapienza, Dipartimento Materno Infantile e Scienze Urologiche, AOU Policlinico Umberto I di Roma, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Tasca', 'Affiliation': 'Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Tettamanzi', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Maria Francesca', 'Initials': 'MF', 'LastName': 'Alvisi', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Poli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Carlucci', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Roldano', 'Initials': 'R', 'LastName': 'Fossati', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Biagioli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy. Electronic address: elena.biagioli@marionegri.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gynecologic oncology,['10.1016/j.ygyno.2022.01.015']
1681,35063278,"A randomized phase II trial of everolimus and letrozole or hormonal therapy in women with advanced, persistent or recurrent endometrial carcinoma: A GOG Foundation study.","BACKGROUND


Blocking the PI3K/AKT/mTOR pathway decreases resistance to hormonal therapy in endometrial carcinoma (EC).
OBJECTIVE


In this study, the aim was to assess the efficacy and tolerability of everolimus(E)/letrozole (L) or medroxyprogesterone acetate(M)/tamoxifen(T) in the treatment of metastatic EC.
STUDY DESIGN


This single stage, open-label two arm randomized phase II trial accrued women with advanced/persistent/recurrent EC. Treatment with E (10 mg daily) and L (2.5 mg daily) or T (20 mg twice daily) and M (200 mg daily alternating weeks) was randomly assigned, and stratified by prior adjuvant therapy. Treatments were administered orally. Primary endpoint was response rate.
RESULTS


Between February 2015 and April 2016, everolimus/letrozole (n = 37) or MT (n = 37) was assigned to 74 patients. Median follow-up was 37 months. Eight (22%; 95% CI 11% to 37%) patients responded on EL (one CR) and nine (25%; 95% CI 14% to 41%) patients responded on MT (three CRs). Median PFS for EL and MT arms was 6 months and 4 months, respectively. On EL, chemo-nave patients demonstrated a 28 month median PFS; prior chemotherapy patients had a 4-month median PFS. On MT, patients without prior therapy had a 5-month median PFS; those with prior chemotherapy demonstrated a 3-month PFS. Common grade 3 adverse events were anemia (9 [24%] patients EL vs 2 [6%] MT) and mucositis (2 [5%] vs 0 [0%]). Grade 3/4 thromboembolic events were observed with MT but not with EL (0 [0%] vs 4 [11%]).
CONCLUSIONS


EL and MT demonstrated clinically meaningful efficacy in recurrent EC patients. The higher PFS observed in chemo-naïve patients is worthy of confirmation in future studies.",2022,"Grade 3/4 thromboembolic events were observed with MT but not with EL (0 [0%] vs 4 [11%]).
","['women with advanced, persistent or recurrent endometrial carcinoma', 'endometrial carcinoma (EC', 'women with advanced/persistent/recurrent EC', 'recurrent EC patients']","['everolimus and letrozole or hormonal therapy', 'everolimus/letrozole', 'MT', 'everolimus(E)/letrozole (L) or medroxyprogesterone acetate(M)/tamoxifen(T']","['Grade 3/4 thromboembolic events', 'response rate', 'efficacy and tolerability', 'mucositis', 'Median PFS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0278802', 'cui_str': 'Endometrial cancer recurrent'}, {'cui': 'C0476089', 'cui_str': 'Endometrial carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0701939,"Grade 3/4 thromboembolic events were observed with MT but not with EL (0 [0%] vs 4 [11%]).
","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Slomovitz', 'Affiliation': 'Division of Gynecologic Oncology, Mount Sinai Medical Center, Miami Beach, Florida, USA. Electronic address: bslomovitz@gog.org.'}, {'ForeName': 'Virginia L', 'Initials': 'VL', 'LastName': 'Filiaci', 'Affiliation': 'Clinical Trial Development Division, Department of Biostatistics and Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY 14263, USA.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Walker', 'Affiliation': 'Section of Gynecologic Oncology, Stephenson Cancer Center at University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Taub', 'Affiliation': 'Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Finkelstein', 'Affiliation': ""Southwest Women's Oncology, Albuquerque, NM 87106, USA.""}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Moroney', 'Affiliation': 'Section of Gynecologic Oncology, Department of Obstetrics & Gynecology, University of Chicago Medicine, Chicago, IL, USA.'}, {'ForeName': 'Aimee C', 'Initials': 'AC', 'LastName': 'Fleury', 'Affiliation': ""Department of Gynecologic Oncology, Women's Cancer Center of Nevada, Las Vegas, NV 89169, USA.""}, {'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Muller', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of New Mexico School of Medicine, Albuquerque, NM, USA.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Holman', 'Affiliation': 'Section of Gynecologic Oncology, Stephenson Cancer Center at University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'Larry J', 'Initials': 'LJ', 'LastName': 'Copeland', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics/Gynecology, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Miller', 'Affiliation': 'Department of Obstetrics and Gynecology, UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'US Oncology Research, The Woodlands, TX, USA.'}]",Gynecologic oncology,['10.1016/j.ygyno.2021.12.031']
1682,35065008,A three-step support strategy for relatives of patients dying in the intensive care unit: a cluster randomised trial.,"BACKGROUND


In relatives of patients dying in intensive care units (ICUs), inadequate team support can increase the prevalence of prolonged grief and other psychological harm. We aimed to evaluate whether a proactive communication and support intervention would improve relatives' outcomes.
METHODS


We undertook a prospective, multicentre, cluster randomised controlled trial in 34 ICUs in France, to compare standard care with a physician-driven, nurse-aided, three-step support strategy for families throughout the dying process, following a decision to withdraw or withhold life support. Inclusion criteria were relatives of patients older than 18 years with an ICU length of stay 2 days or longer. Participating ICUs were randomly assigned (1:1 ratio) into an intervention cluster and a control cluster. The randomisation scheme was generated centrally by a statistician not otherwise involved in the study, using permutation blocks of non-released size. In the intervention group, three meetings were held with relatives: a family conference to prepare the relatives for the imminent death, an ICU-room visit to provide active support, and a meeting after the patient's death to offer condolences and closure. ICUs randomly assigned to the control group applied their best standard of care in terms of support and communication with relatives of dying patients. The primary endpoint was the proportion of relatives with prolonged grief (measured with PG-13, score ≥30) 6 months after the death. Analysis was by intention to treat, with the bereaved relatives as the unit of observation. The study is registered with ClinicalTrials.gov, NCT02955992.
FINDINGS


Between Feb 23, 2017, and Oct 8, 2019, we enrolled 484 relatives of ICU patients to the intervention group and 391 to the control group. 379 (78%) relatives in the intervention group and 309 (79%) in the control group completed the 6-month interview to measure the primary endpoint. The intervention significantly reduced the number of relatives with prolonged grief symptoms (66 [21%] vs 57 [15%]; p=0·035) and the median PG-13 score was significantly lower in the intervention group than in the control group (19 [IQR 14-26] vs 21 [15-29], mean difference 2·5, 95% CI 1·04-3·95).
INTERPRETATION


Among relatives of patients dying in the ICU, a physician-driven, nurse-aided, three-step support strategy significantly reduced prolonged grief symptoms.
FUNDING


French Ministry of Health.",2022,ICUs randomly assigned to the control group applied their best standard of care in terms of support and communication with relatives of dying patients.,"['enrolled 484 relatives of ICU patients to the intervention group and 391 to the control group', '34 ICUs in France', 'Inclusion criteria were relatives of patients older than 18 years with an ICU length of stay 2 days or longer', 'Between Feb 23, 2017, and Oct 8, 2019']","['proactive communication and support intervention', 'standard care with a physician-driven, nurse-aided, three-step support strategy']","['prolonged grief symptoms', 'median PG-13 score', 'proportion of relatives with prolonged grief', 'number of relatives with prolonged grief symptoms']","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0028663', 'cui_str': 'Nursing aid'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",484.0,0.0690381,ICUs randomly assigned to the control group applied their best standard of care in terms of support and communication with relatives of dying patients.,"[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Kentish-Barnes', 'Affiliation': 'AP-HP Nord, Saint Louis Hospital, Medical Intensive Care, Famiréa Research Group, Paris, France. Electronic address: nancy.kentish@aphp.fr.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chevret', 'Affiliation': 'Department of Biostatistics and Medical Information, UMR 1153, ECSTRRA Team, INSERM, Paris University, Saint Louis Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Valade', 'Affiliation': 'AP-HP Nord, Saint Louis Hospital, Medical Intensive Care, Famiréa Research Group, Paris, France; AP-HP Centre, Cochin Hospital, Medical Intensive Care, Paris, France.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Jaber', 'Affiliation': 'Saint Eloi University Hospital, Department of Anesthesia and Critical Care Medicine, Montpellier and PhyMedExp, University of Montpellier, INSERM, CNRS, Montpellier, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Kerhuel', 'Affiliation': 'AP-HP Nord, Saint Louis Hospital, Medical Intensive Care, Famiréa Research Group, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Guisset', 'Affiliation': 'Saint André University Hospital, Medical Intensive Care, Bordeaux, France.'}, {'ForeName': 'Maëlle', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Hôtel Dieu University Hospital, Medical Intensive Care, Nantes, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Mazaud', 'Affiliation': 'Hospices Civils de Lyon, Edouard Herriot University Hospital, Surgical Intensive Care, Lyon, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Papazian', 'Affiliation': ""AP-HM, Hôpital Nord, Medical Intensive Care and Aix-Marseille University, Faculté des Sciences Médicales et Paramédicales, Centre d'Etudes et de Recherches sur les Services de Santé et qualité de vie EA 3279, Marseille, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Argaud', 'Affiliation': 'Hospices Civils de Lyon, Edouard Herriot Hospital, Medical Intensive Care, and Université de Lyon, Lyon, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Demoule', 'Affiliation': 'AP-HP Sorbonne Université, La Pitié-Salpêtrière University Hospital, Medical Intensive Care Unit and Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schnell', 'Affiliation': 'Angoulême Hospital, Medical and Surgical Intensive Care, Angoulême, France.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Bretagne Atlantique Hospital, Medical and Surgical Intensive Care, Vannes, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Ethuin', 'Affiliation': 'Côte de Nacre University Hospital, Surgical Intensive Care, Caen, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Hammad', 'Affiliation': 'AP-HM, Hospital Nord, Anaesthesia and Intensive Care, Marseille, France.'}, {'ForeName': 'Sybille', 'Initials': 'S', 'LastName': 'Merceron', 'Affiliation': 'André Mignot Hospital, Medical Intensive Care, Le Chesnay, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Audibert', 'Affiliation': 'Louis Pasteur Hospital, Medical and Surgical Intensive Care, Chartres, France.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Blayau', 'Affiliation': 'AP-HP Sorbonne University, Tenon Hospital, Medical Intensive Care, Paris, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Delannoy', 'Affiliation': 'Chatilliez Hospital, Medical and Surgical Intensive Care, Tourcoing, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lautrette', 'Affiliation': 'Gabriel Montpied University Hospital, Medical Intensive Care, Clermont Ferrand, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Lesieur', 'Affiliation': 'La Rochelle Hospital, Medical and Surgical Intensive Care, La Rochelle, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Renault', 'Affiliation': 'Cavale Blanche University Hospital, Medical Intensive Care, Brest, France.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Reuter', 'Affiliation': 'Sud Francilien Hospital, Medical and Surgical Intensive Care, Evry, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Terzi', 'Affiliation': 'Grenoble Alpes University Hospital, Medical Intensive Care, Grenoble, France.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Philippon-Jouve', 'Affiliation': 'Roanne Hospital, Medical and Surgical Intensive Care, Roanne, France.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Fiancette', 'Affiliation': 'Les Oudairies Hospital, Medical and Surgical Intensive Care, La Roche-sur-Yon, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ramakers', 'Affiliation': 'Saint Lô Hospital, Medical and Surgical Intensive Care, Saint Lô, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Rigaud', 'Affiliation': 'Dieppe Hospital, Medical and Surgical Intensive Care, Dieppe, Paris.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Souppart', 'Affiliation': 'AP-HP Nord, Saint Louis Hospital, Medical Intensive Care, Famiréa Research Group, Paris, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': 'Hôtel Dieu University Hospital, Department of Anesthesia and Critical Care, Nantes, France.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Champigneulle', 'Affiliation': 'AP-HP Centre, Hôpital Européen Georges Pompidou, Department of Aaesthesia and Critical Care, Paris, France.'}, {'ForeName': 'Dany', 'Initials': 'D', 'LastName': 'Goldgran-Toledano', 'Affiliation': 'Montfermeil Hospital, Medical and Surgical Intensive Care, Montfermeil, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Dubost', 'Affiliation': 'René Dubos Hospital, Medical and Surgical Intensive Care, Pontoise, France.'}, {'ForeName': 'Pierre-Edouard', 'Initials': 'PE', 'LastName': 'Bollaert', 'Affiliation': 'University Hospital Central, Medical Intensive Care, Nancy, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Chouquer', 'Affiliation': 'Annecy Hospital, Medical and Surgical Intensive Care, Annecy, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Pochard', 'Affiliation': 'AP-HP Nord, Saint Louis Hospital, Medical Intensive Care, Famiréa Research Group, Paris, France; AP-HP Nord, Fernand Widal Hospital, DMU Neurosciences, Département de Psychiatrie et de Médecine Addictologique, Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Cariou', 'Affiliation': 'AP-HP Centre, Cochin Hospital, Medical Intensive Care, Paris, France; Paris University, Paris, France.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Azoulay', 'Affiliation': 'AP-HP Nord, Saint Louis Hospital, Medical Intensive Care, Famiréa Research Group, Paris, France; Department of Biostatistics and Medical Information, UMR 1153, ECSTRRA Team, INSERM, Paris University, Saint Louis Hospital, AP-HP, Paris, France.'}]","Lancet (London, England)",['10.1016/S0140-6736(21)02176-0']
1683,35065057,"Perioperative nivolumab monotherapy versus nivolumab plus ipilimumab in resectable hepatocellular carcinoma: a randomised, open-label, phase 2 trial.","BACKGROUND


Hepatocellular carcinoma has high recurrence rates after surgery; however, there are no approved standard-of-care neoadjuvant or adjuvant therapies. Immunotherapy has been shown to improve survival in advanced hepatocellular carcinoma; we therefore aimed to evaluate the safety and tolerability of perioperative immunotherapy in resectable hepatocellular carcinoma.
METHODS


In this single-centre, randomised, open-label, phase 2 trial, patients with resectable hepatocellular carcinoma were randomly assigned (1:1) to receive 240 mg of nivolumab intravenously every 2 weeks (for up to three doses before surgery at 6 weeks) followed in the adjuvant phase by 480 mg of nivolumab intravenously every 4 weeks for 2 years, or 240 mg of nivolumab intravenously every 2 weeks (for up to three doses before surgery) plus one dose of 1 mg/kg of ipilimumab intravenously concurrently with the first preoperative dose of nivolumab, followed in the adjuvant phase by 480 mg of nivolumab intravenously every 4 weeks for up to 2 years plus 1 mg/kg of ipilimumab intravenously every 6 weeks for up to four cycles. Patients were randomly assigned to the treatment groups by use of block randomisation with a random block size. The primary endpoint was the safety and tolerability of nivolumab with or without ipilimumab. Secondary endpoints were the proportion of patients with an overall response, time to progression, and progression-free survival. This trial is registered with ClinicalTrials.gov (NCT03222076) and is completed.
FINDINGS


Between Oct 30, 2017, and Dec 3, 2019, 30 patients were enrolled and 27 were randomly assigned: 13 to nivolumab and 14 to nivolumab plus ipilimumab. Grade 3-4 adverse events were higher with nivolumab plus ipilimumab (six [43%] of 14 patients) than with nivolumab alone (three [23%] of 13). The most common treatment-related adverse events of any grade were increased alanine aminotransferase (three [23%] of 13 patients on nivolumab vs seven [50%] of 14 patients on nivolumab plus ipilimumab) and increased aspartate aminotransferase (three [23%] vs seven [50%]). No patients in either group had their surgery delayed due to grade 3 or worse adverse events. Seven of 27 patients had surgical cancellations, but none was due to treatment-related adverse events. Estimated median progression-free survival was 9·4 months (95% CI 1·47-not estimable [NE]) with nivolumab and 19·53 months (2·33-NE) with nivolumab plus ipilimumab (hazard ratio [HR] 0·99, 95% CI 0·31-2·54); median time to progression was 9·4 months (95% CI 1·47-NE) in the nivolumab group and 19·53 months (2·33-NE) in the nivolumab plus ipilimumab group (HR 0·89, 95% CI 0·31-2·54). In an exploratory analysis, three (23%) of 13 patients had an overall response with nivolumab monotherapy, versus none with nivolumab plus ipilimumab. Three (33%) of nine patients had a major pathological response (ie, ≥70% necrosis in the resected tumour area) with nivolumab monotherapy compared with three (27%) of 11 with nivolumab plus ipilimumab.
INTERPRETATION


Perioperative nivolumab alone and nivolumab plus ipilimumab appears to be safe and feasible in patients with resectable hepatocellular carcinoma. Our findings support further studies of immunotherapy in the perioperative setting in hepatocellular carcinoma.
FUNDING


Bristol Myers Squibb and the US National Institutes of Health.",2022,"Estimated median progression-free survival was 9·4 months (95% CI 1·47-not estimable [NE]) with nivolumab and 19·53 months (2·33-NE) with nivolumab plus ipilimumab (hazard ratio [HR] 0·99, 95% CI 0·31-2·54); median time to progression was 9·4 months (95% CI 1·47-NE) in the nivolumab group and 19·53 months (2·33-NE) in the nivolumab plus ipilimumab group (HR 0·89, 95% CI 0·31-2·54).","['hepatocellular carcinoma', 'patients with resectable hepatocellular carcinoma', 'advanced hepatocellular carcinoma', 'resectable hepatocellular carcinoma', 'Between Oct 30, 2017, and Dec 3, 2019, 30 patients were enrolled and 27 were randomly assigned: 13 to']","['nivolumab and 14 to nivolumab plus ipilimumab', 'Perioperative nivolumab monotherapy', 'nivolumab', 'ipilimumab', 'Immunotherapy', 'nivolumab plus ipilimumab', 'ipilimumab intravenously concurrently with the first preoperative dose of nivolumab, followed in the adjuvant phase by 480 mg of nivolumab', 'nivolumab monotherapy', 'nivolumab alone and nivolumab plus ipilimumab']","['safety and tolerability', 'Estimated median progression-free survival', 'surgical cancellations', 'Grade 3-4 adverse events', 'safety and tolerability of nivolumab with or without ipilimumab', 'proportion of patients with an overall response, time to progression, and progression-free survival', 'aspartate aminotransferase', 'surgery delayed due to grade 3 or worse adverse events', 'alanine aminotransferase', 'major pathological response']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0863194', 'cui_str': 'Hepatoma resectable'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",30.0,0.317717,"Estimated median progression-free survival was 9·4 months (95% CI 1·47-not estimable [NE]) with nivolumab and 19·53 months (2·33-NE) with nivolumab plus ipilimumab (hazard ratio [HR] 0·99, 95% CI 0·31-2·54); median time to progression was 9·4 months (95% CI 1·47-NE) in the nivolumab group and 19·53 months (2·33-NE) in the nivolumab plus ipilimumab group (HR 0·89, 95% CI 0·31-2·54).","[{'ForeName': 'Ahmed Omar', 'Initials': 'AO', 'LastName': 'Kaseb', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: akaseb@mdanderson.org.'}, {'ForeName': 'Elshad', 'Initials': 'E', 'LastName': 'Hasanov', 'Affiliation': 'Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Hop Sanderson Tran', 'Initials': 'HST', 'LastName': 'Cao', 'Affiliation': 'Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lianchun', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jean-Nicolas', 'Initials': 'JN', 'LastName': 'Vauthey', 'Affiliation': 'Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sunyoung S', 'Initials': 'SS', 'LastName': 'Lee', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Betul Gok', 'Initials': 'BG', 'LastName': 'Yavuz', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yehia I', 'Initials': 'YI', 'LastName': 'Mohamed', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Aliya', 'Initials': 'A', 'LastName': 'Qayyum', 'Affiliation': 'Department of Abdominal Imaging, Division of Diagnostic Imaging, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Jindal', 'Affiliation': 'Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Duan', 'Affiliation': 'Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sreyashi', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Shalini S', 'Initials': 'SS', 'LastName': 'Yadav', 'Affiliation': 'Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Nicholas', 'Affiliation': 'Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jing Jing', 'Initials': 'JJ', 'LastName': 'Sun', 'Affiliation': 'Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kanwal Pratap', 'Initials': 'KP', 'LastName': 'Singh Raghav', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Rashid', 'Affiliation': 'Department of Pathology, Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Carter', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yun Shin', 'Initials': 'YS', 'LastName': 'Chun', 'Affiliation': 'Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ching-Wei David', 'Initials': 'CD', 'LastName': 'Tzeng', 'Affiliation': 'Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Sakamuri', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Cristini', 'Affiliation': 'Mathematics in Medicine Program, Houston Methodist Research Institute, Houston, TX, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Beretta', 'Affiliation': 'Department of Molecular and Cellular Oncology, Division of Basic Sciences, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Yao', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wolff', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'James Patrick', 'Initials': 'JP', 'LastName': 'Allison', 'Affiliation': 'Department of Pathology, Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; Department of Immunology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Padmanee', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Immunotherapy Platform, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; Department of Immunology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: padsharma@mdanderson.org.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(21)00427-1']
1684,35065407,The aerobic capacity - fatigue relationship in persons with Multiple Sclerosis is not reproducible in a pooled analysis of two randomized controlled trials.,"BACKGROUND


Fatigue is one of the most frequent symptoms of persons with Multiple Sclerosis (pwMS) but has limited treatment options. Aerobic capacity and endurance training have been discussed as relevant factors to improve fatigue. However, over the last decades, results have been equivocal. This secondary analysis of two pooled parallel group RCTs of three weeks of endurance training (high intensity interval training (HIIT) and moderate continuous training (MCT)) for pwMS aimed to (I) reproduce reported associations between aerobic capacity and fatigue on a cross-sectional and interventional level. The analysis further aimed to (II) investigate intervention effects on fatigue in a severely fatigued subgroup and (III) analyze differences in changes of fatigue between peak oxygen uptake (VO 2peak ) responders and non-responders.
METHODS


Both RCTs were conducted in the same inpatient rehabilitation clinic in Valens, Switzerland. Original primary outcomes were cognitive function (RCT1) and change in proportion of circulating regulatory T-cells (RCT2). PwMS (n = 131) with a relapsing-remitting or secondary progressive MS phenotype and Expanded Disability Status Scale score between 1 - 6.5 were eligible. Over the two studies participants exercised 3 - 5 times per week on cycle ergometers at intensities of 65 - 70% of maximum heart rate (HR max ) for 30 min (MCT groups) or three times per week with five 90 - 180 s intervals at intensities of 85% - 100% of HR max  and 90 s rest intervals (HIIT groups). Main outcome measures for the present secondary analysis were VO 2peak  measured during a cardiopulmonary exercise test and the Fatigue Scale for Motor and Cognitive Functions (FSMC), both assessed at the start and end of inpatient rehabilitation.
RESULTS


Baseline correlations did not reveal a significant association between VO 2peak  and FSMC. There were no significant improvements in fatigue after the HIIT and MCT in the overall sample or the subsample of severely fatigued pwMS and no significant differences in fatigue changes between VO 2peak -responders and non-responders.
CONCLUSIONS


Our analysis did not confirm the aerobic capacity - fatigue relationship on a cross-sectional and experimental level, even when analyzing subgroups that should benefit the most according to proposed hypotheses.",2022,"There were no significant improvements in fatigue after the HIIT and MCT in the overall sample or the subsample of severely fatigued pwMS and no significant differences in fatigue changes between VO 2peak -responders and non-responders.
","['persons with Multiple Sclerosis (pwMS', 'Both RCTs were conducted in the same inpatient rehabilitation clinic in Valens, Switzerland', 'persons with Multiple Sclerosis']","['Aerobic capacity and endurance training', 'endurance training (high intensity interval training (HIIT) and moderate continuous training (MCT']","['VO 2peak  and FSMC', 'fatigue changes', 'fatigue', 'VO 2peak', 'cognitive function (RCT1) and change in proportion of circulating regulatory T-cells (RCT2', 'relapsing-remitting or secondary progressive MS phenotype and Expanded Disability Status Scale score', 'Fatigue Scale for Motor and Cognitive Functions (FSMC']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.163421,"There were no significant improvements in fatigue after the HIIT and MCT in the overall sample or the subsample of severely fatigued pwMS and no significant differences in fatigue changes between VO 2peak -responders and non-responders.
","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Wolf', 'Affiliation': 'Neurological Rehabilitation Centre Godeshoehe, Bonn, Germany; Department of Molecular and Cellular Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Rademacher', 'Affiliation': 'Department of Molecular and Cellular Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany; Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Joisten', 'Affiliation': 'Division of Performance and Health (Sports Medicine), Institute for Sport and Sport Science, TU Dortmund University, Dortmund, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Proschinger', 'Affiliation': 'Department of Molecular and Cellular Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Marit Lea', 'Initials': 'ML', 'LastName': 'Schlagheck', 'Affiliation': 'Division of Performance and Health (Sports Medicine), Institute for Sport and Sport Science, TU Dortmund University, Dortmund, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'Department of Molecular and Cellular Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Gonzenbach', 'Affiliation': 'Department of Neurology, Clinics of Valens, Rehabilitation Centre Valens, Valens, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kool', 'Affiliation': 'Department of Neurology, Clinics of Valens, Rehabilitation Centre Valens, Valens, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bansi', 'Affiliation': 'Department of Neurology, Clinics of Valens, Rehabilitation Centre Valens, Valens, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Division of Performance and Health (Sports Medicine), Institute for Sport and Sport Science, TU Dortmund University, Dortmund, Germany. Electronic address: philipp.zimmer@tu-dortmund.de.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.103476']
1685,35065784,Efficacy and safety of oral immunotherapy in children aged 1-3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study.,"BACKGROUND


For young children with peanut allergy, dietary avoidance is the current standard of care. We aimed to assess whether peanut oral immunotherapy can induce desensitisation (an increased allergic reaction threshold while on therapy) or remission (a state of non-responsiveness after discontinuation of immunotherapy) in this population.
METHODS


We did a randomised, double-blind, placebo-controlled study in five US academic medical centres. Eligible participants were children aged 12 to younger than 48 months who were reactive to 500 mg or less of peanut protein during a double-blind, placebo-controlled food challenge (DBPCFC). Participants were randomly assigned by use of a computer, in a 2:1 allocation ratio, to receive peanut oral immunotherapy or placebo for 134 weeks (2000 mg peanut protein per day) followed by 26 weeks of avoidance, with participants and study staff and investigators masked to group treatment assignment. The primary outcome was desensitisation at the end of treatment (week 134), and remission after avoidance (week 160), as the key secondary outcome, were assessed by DBPCFC to 5000 mg in the intention-to-treat population. Safety and immunological parameters were assessed in the same population. This trial is registered on ClinicalTrials.gov, NCT03345160.
FINDINGS


Between Aug 13, 2013, and Oct 1, 2015, 146 children, with a median age of 39·3 months (IQR 30·8-44·7), were randomly assigned to receive peanut oral immunotherapy (96 participants) or placebo (50 participants). At week 134, 68 (71%, 95% CI 61-80) of 96 participants who received peanut oral immunotherapy compared with one (2%, 0·05-11) of 50 who received placebo met the primary outcome of desensitisation (risk difference [RD] 69%, 95% CI 59-79; p<0·0001). The median cumulative tolerated dose during the week 134 DBPCFC was 5005 mg (IQR 3755-5005) for peanut oral immunotherapy versus 5 mg (0-105) for placebo (p<0·0001). After avoidance, 20 (21%, 95% CI 13-30) of 96 participants receiving peanut oral immunotherapy compared with one (2%, 0·05-11) of 50 receiving placebo met remission criteria (RD 19%, 95% CI 10-28; p=0·0021). The median cumulative tolerated dose during the week 160 DBPCFC was 755 mg (IQR 0-2755) for peanut oral immunotherapy and 0 mg (0-55) for placebo (p<0·0001). A significant proportion of participants receiving peanut oral immunotherapy who passed the 5000 mg DBPCFC at week 134 could no longer tolerate 5000 mg at week 160 (p<0·001). The participant receiving placebo who was desensitised at week 134 also achieved remission at week 160. Compared with placebo, peanut oral immunotherapy decreased peanut-specific and Ara h2-specific IgE, skin prick test, and basophil activation, and increased peanut-specific and Ara h2-specific IgG4 at weeks 134 and 160. By use of multivariable regression analysis of participants receiving peanut oral immunotherapy, younger age and lower baseline peanut-specific IgE was predictive of remission. Most participants (98% with peanut oral immunotherapy vs 80% with placebo) had at least one oral immunotherapy dosing reaction, predominantly mild to moderate and occurring more frequently in participants receiving peanut oral immunotherapy. 35 oral immunotherapy dosing events with moderate symptoms were treated with epinephrine in 21 participants receiving peanut oral immunotherapy.
INTERPRETATION


In children with a peanut allergy, initiation of peanut oral immunotherapy before age 4 years was associated with an increase in both desensitisation and remission. Development of remission correlated with immunological biomarkers. The outcomes suggest a window of opportunity at a young age for intervention to induce remission of peanut allergy.
FUNDING


National Institute of Allergy and Infectious Disease, Immune Tolerance Network.",2022,"Compared with placebo, peanut oral immunotherapy decreased peanut-specific and Ara h2-specific IgE, skin prick test, and basophil activation, and increased peanut-specific and Ara","['children aged 1-3 years with peanut allergy (the Immune Tolerance Network IMPACT trial', 'Between Aug 13, 2013, and Oct 1, 2015, 146 children, with a median age of 39·3 months (IQR 30·8-44·7', '21 participants receiving', 'Eligible participants were children aged 12 to younger than 48 months who were reactive to 500 mg or less of peanut protein during a double-blind, placebo-controlled food challenge (DBPCFC', 'five US academic medical centres']","['oral immunotherapy', 'placebo', 'epinephrine', 'placebo, peanut oral immunotherapy', 'peanut oral immunotherapy or placebo', 'peanut oral immunotherapy']","['Efficacy and safety', 'median cumulative tolerated', 'h2-specific', 'Safety and immunological parameters', 'peanut-specific and Ara h2-specific IgE, skin prick test, and basophil activation, and increased peanut-specific and Ara']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0020963', 'cui_str': 'Immunologic tolerance'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1442824', 'cui_str': 'POU2F1 protein, human'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0325983', 'cui_str': 'Genus Ara'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.479203,"Compared with placebo, peanut oral immunotherapy decreased peanut-specific and Ara h2-specific IgE, skin prick test, and basophil activation, and increased peanut-specific and Ara","[{'ForeName': 'Stacie M', 'Initials': 'SM', 'LastName': 'Jones', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, AR, USA. Electronic address: jonesstaciem@uams.edu.""}, {'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Departments of Medicine and Pediatrics, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Nadeau', 'Affiliation': 'Department of Pediatrics and Sean N Parker Center for Allergy and Asthma Research, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nowak-Wegrzyn', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Pediatrics, New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wood', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Scurlock', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, AR, USA.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Chinthrajah', 'Affiliation': 'Department of Pediatrics and Sean N Parker Center for Allergy and Asthma Research, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Pesek', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, AR, USA.""}, {'ForeName': 'Sayantani B', 'Initials': 'SB', 'LastName': 'Sindher', 'Affiliation': 'Department of Pediatrics and Sean N Parker Center for Allergy and Asthma Research, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Kulis', 'Affiliation': 'Departments of Medicine and Pediatrics, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'Rho Federal Systems Division, Durham, NC, USA.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Spain', 'Affiliation': 'Rho Federal Systems Division, Durham, NC, USA.'}, {'ForeName': 'Denise C', 'Initials': 'DC', 'LastName': 'Babineau', 'Affiliation': 'Rho Federal Systems Division, Durham, NC, USA.'}, {'ForeName': 'Hyunsook', 'Initials': 'H', 'LastName': 'Chin', 'Affiliation': 'Rho Federal Systems Division, Durham, NC, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Laurienzo-Panza', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Yan', 'Affiliation': 'The Immune Tolerance Network, San Francisco, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Larson', 'Affiliation': 'The Immune Tolerance Network, Bethesda, MD, USA.'}, {'ForeName': 'Tielin', 'Initials': 'T', 'LastName': 'Qin', 'Affiliation': 'The Immune Tolerance Network, Bethesda, MD, USA.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Whitehouse', 'Affiliation': 'The Immune Tolerance Network, San Francisco, CA, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Sever', 'Affiliation': 'Rho Federal Systems Division, Durham, NC, USA.'}, {'ForeName': 'Srinath', 'Initials': 'S', 'LastName': 'Sanda', 'Affiliation': 'The Immune Tolerance Network, San Francisco, CA, USA.'}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Plaut', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Wheatley', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'A Wesley', 'Initials': 'AW', 'LastName': 'Burks', 'Affiliation': 'Departments of Medicine and Pediatrics, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)02390-4']
1686,34887529,Insulin and glucose metabolism with olanzapine and a combination of olanzapine and samidorphan: exploratory phase 1 results in healthy volunteers.,"A combination of olanzapine and samidorphan (OLZ/SAM) received US Food and Drug Administration approval in May 2021 for the treatment of adults with schizophrenia or bipolar I disorder. OLZ/SAM provides the efficacy of olanzapine, while mitigating olanzapine-associated weight gain. This exploratory study characterized the metabolic profile of OLZ/SAM in healthy volunteers to gain mechanistic insights. Volunteers received once-daily oral 10 mg/10 mg OLZ/SAM, 10 mg olanzapine, or placebo for 21 days. Assessments included insulin sensitivity during an oral glucose tolerance test (OGTT), hyperinsulinemic-euglycemic clamp, other measures of glucose/lipid metabolism, and adverse event (AE) monitoring. Treatment effects were estimated with analysis of covariance. In total, 60 subjects were randomized (double-blind; placebo, n = 12; olanzapine, n = 24; OLZ/SAM, n = 24). Olanzapine resulted in hyperinsulinemia and reduced insulin sensitivity during an OGTT at day 19, changes not observed with OLZ/SAM or placebo. Insulin sensitivity, measured by hyperinsulinemic-euglycemic clamp, was decreased in all treatment groups relative to baseline, but this effect was greatest with olanzapine and OLZ/SAM. Although postprandial (OGTT) glucose and fasting cholesterol concentrations were similarly increased with olanzapine or OLZ/SAM, other early metabolic effects were distinct, including post-OGTT C-peptide concentrations and aspects of energy metabolism. Forty-nine subjects (81.7%) experienced at least 1 AE, most mild or moderate in severity. OLZ/SAM appeared to mitigate some of olanzapine's unfavorable postprandial metabolic effects (e.g., hyperinsulinemia, elevated C-peptide) in this exploratory study. These findings supplement the body of evidence from completed or ongoing OLZ/SAM clinical trials supporting its role in the treatment of schizophrenia and bipolar I disorder.",2022,"Insulin sensitivity, measured by hyperinsulinemic-euglycemic clamp, was decreased in all treatment groups relative to baseline, but this effect was greatest with olanzapine and OLZ/SAM.","['60 subjects', 'adults with schizophrenia or bipolar I disorder', 'healthy volunteers']","['placebo', 'Olanzapine', 'olanzapine and OLZ/SAM', 'olanzapine', 'olanzapine and samidorphan (OLZ/SAM', 'OLZ/SAM', 'olanzapine, or placebo', 'olanzapine, n\u2009=\u200924; OLZ/SAM', 'olanzapine and samidorphan']","['hyperinsulinemia and reduced insulin sensitivity', 'hyperinsulinemic-euglycemic clamp', 'postprandial (OGTT) glucose and fasting cholesterol concentrations', 'Insulin sensitivity', 'insulin sensitivity during an oral glucose tolerance test (OGTT), hyperinsulinemic-euglycemic clamp, other measures of glucose/lipid metabolism, and adverse event (AE) monitoring', 'Insulin and glucose metabolism']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}]","[{'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",60.0,0.166854,"Insulin sensitivity, measured by hyperinsulinemic-euglycemic clamp, was decreased in all treatment groups relative to baseline, but this effect was greatest with olanzapine and OLZ/SAM.","[{'ForeName': 'Frederico G S', 'Initials': 'FGS', 'LastName': 'Toledo', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Martin', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Morrow', 'Affiliation': 'ProSciento, Inc., Chula Vista, CA, USA.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Beysen', 'Affiliation': 'ProSciento, Inc., Chula Vista, CA, USA.'}, {'ForeName': 'Daiva', 'Initials': 'D', 'LastName': 'Bajorunas', 'Affiliation': 'Vault Bioventures, San Diego, CA, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Bernard L', 'Initials': 'BL', 'LastName': 'Silverman', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McDonnell', 'Affiliation': 'Alkermes Pharma Ireland Limited, Dublin, Ireland.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Namchuk', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newcomer', 'Affiliation': 'Thriving Mind South Florida, Miami, FL, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Graham', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA. Christine.Graham@alkermes.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-01244-7']
1687,35062340,Efficacy of Corticosteroid Therapy for HTLV-1-Associated Myelopathy: A Randomized Controlled Trial (HAMLET-P).,"Corticosteroids are most commonly used to treat HTLV-1-associated myelopathy (HAM); however, their clinical efficacy has not been tested in randomized clinical trials. This randomized controlled trial included 8 and 30 HAM patients with rapidly and slowly progressing walking disabilities, respectively. Rapid progressors were assigned (1:1) to receive or not receive a 3-day course of intravenous methylprednisolone in addition to oral prednisolone therapy. Meanwhile, slow progressors were assigned (1:1) to receive oral prednisolone or placebo. The primary outcomes were a composite of ≥1-grade improvement in the Osame Motor Disability Score or ≥30% improvement in the 10 m walking time (10 mWT) at week 2 for rapid progressors and changes from baseline in 10 mWT at week 24 for slow progressors. In the rapid progressor trial, all four patients with but only one of four without intravenous methylprednisolone achieved the primary outcome ( p  = 0.14). In the slow progressor trial, the median changes in 10 mWT were -13.8% (95% CI: -20.1--7.1;  p  < 0.001) and -6.0% (95% CI: -12.8-1.3;  p  = 0.10) with prednisolone and placebo, respectively ( p  for between-group difference = 0.12). Whereas statistical significance was not reached for the primary endpoints, the overall data indicated the benefit of corticosteroid therapy. (Registration number: UMIN000023798, UMIN000024085).",2022,"Whereas statistical significance was not reached for the primary endpoints, the overall data indicated the benefit of corticosteroid therapy.","['HTLV-1-Associated Myelopathy', '30 HAM patients with rapidly and slowly progressing walking disabilities, respectively']","['placebo', 'oral prednisolone or placebo', 'prednisolone', 'prednisolone therapy', 'methylprednisolone', 'Corticosteroids', 'Corticosteroid Therapy']",['composite of ≥1-grade improvement in the Osame Motor Disability Score or ≥30% improvement in the 10 m walking time (10 mWT'],"[{'cui': 'C0020094', 'cui_str': 'Human T-lymphotropic virus 1'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",4.0,0.810533,"Whereas statistical significance was not reached for the primary endpoints, the overall data indicated the benefit of corticosteroid therapy.","[{'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Department of Frontier Medicine, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8511, Japan.'}, {'ForeName': 'Tomoo', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Neurology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto 602-8566, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Matsuura', 'Affiliation': 'Department of Neurology and Geriatrics, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Fukuoka University, Fukuoka 814-0180, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Tamaki', 'Affiliation': 'Department of Neurology, Fukuoka University, Fukuoka 814-0180, Japan.'}, {'ForeName': 'Hirokuni', 'Initials': 'H', 'LastName': 'Sakima', 'Affiliation': 'Department of Cardiovascular Medicine, Nephrology and Neurology, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ishihara', 'Affiliation': 'Department of Cardiovascular Medicine, Nephrology and Neurology, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Ohta', 'Affiliation': 'Department of Pharmacology, St. Marianna University School of Medicine, Kawasaki 216-8511, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Pharmacology, St. Marianna University School of Medicine, Kawasaki 216-8511, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Kono', 'Affiliation': 'Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Kobe 650-0047, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Yagishita', 'Affiliation': 'Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan.'}, {'ForeName': 'Natsumi', 'Initials': 'N', 'LastName': 'Araya', 'Affiliation': 'Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Kunitomo', 'Affiliation': 'Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan.'}, {'ForeName': 'Misako', 'Initials': 'M', 'LastName': 'Nagasaka', 'Affiliation': 'Department of Advanced Medical Innovation, St. Marianna University Graduate School of Medicine, Kawasaki 216-8511, Japan.'}, {'ForeName': 'Ariella', 'Initials': 'A', 'LastName': 'Coler-Reilly', 'Affiliation': 'Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Hasegawa', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki 216-8511, Japan.'}, {'ForeName': 'Abelardo', 'Initials': 'A', 'LastName': 'Araujo', 'Affiliation': 'Laboratory for Clinical Research in Neuroinfections, Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro 21040-900, Brazil.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Jacobson', 'Affiliation': 'Viral immunology Section, Neuroimmunology Branch, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD 20892, USA.'}, {'ForeName': 'Maria Fernanda Rios', 'Initials': 'MFR', 'LastName': 'Grassi', 'Affiliation': 'Escola Bahiana de Medicina e Saúde Pública, Salvador 40290-000, BA, Brazil.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Galvão-Castro', 'Affiliation': 'Escola Bahiana de Medicina e Saúde Pública, Salvador 40290-000, BA, Brazil.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bland', 'Affiliation': 'Department of Health Sciences, Seebohm Rowntree Building, University of York, York YO10 5DD, UK.'}, {'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Taylor', 'Affiliation': 'Section of Virology, Department of Infectious Disease, Imperial College London, London W2 1PG, UK.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Martin', 'Affiliation': 'School of Public Health, Faculty of Medicine, University of Queensland, 266 Herston Road, Herston, QLD 4006, Australia.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Yamano', 'Affiliation': 'Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan.'}]",Viruses,['10.3390/v14010136']
1688,34864678,"The Effect of Olfactory Training on Olfaction, Cognition, and Brain Function in Patients with Mild Cognitive Impairment.","BACKGROUND


The olfactory system is affected very early in Alzheimer's disease and olfactory loss can already be observed in patients with mild cognitive impairment (MCI), an early stage of AD.
OBJECTIVE


The aim of this randomized, prospective, controlled, blinded study was to evaluate whether olfactory training (OT) may have an effect on olfactory function, cognitive impairment, and brain activation in MCI patients after a 4-month period of frequent short-term exposure to various odors.
METHODS


A total of 38 MCI outpatients were randomly assigned to OT or a control training condition, which were performed twice a day for 4 months. Olfactory testing, comprehensive neuropsychological assessment, and a passive odor perception task based on magnetic resonance imaging were performed before and after training.
RESULTS


The results suggested that OT exhibited no significant effect on olfaction and cognitive function. Additionally, OT exhibited a positive effect on frontal lobe activation (left middle frontal gyrus and orbital-frontal cortex) but exhibited no effect on grey matter volume. Moreover, the change of olfactory scores was positively associated with the change of frontal activation.
CONCLUSION


OT was found to have a limited effect on olfaction and cognition in patients with MCI compared to a non-OT condition but increased their functional response to odors in frontal area.",2022,"Additionally, OT exhibited a positive effect on frontal lobe activation (left middle frontal gyrus and orbital-frontal cortex) but exhibited no effect on grey matter volume.","['38 MCI outpatients', 'MCI patients after a 4-month period of frequent short-term exposure to various odors', 'Patients with Mild Cognitive Impairment', 'patients with mild cognitive impairment (MCI), an early stage of AD']","['olfactory training (OT', 'Olfactory Training', 'OT or a control training condition']","['Olfaction, Cognition, and Brain Function', 'olfaction and cognition', 'frontal lobe activation (left middle frontal gyrus and orbital-frontal cortex', 'change of olfactory scores', 'olfaction and cognitive function', 'olfactory function, cognitive impairment, and brain activation', 'grey matter volume']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0152297', 'cui_str': 'Structure of middle frontal gyrus'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",38.0,0.0347777,"Additionally, OT exhibited a positive effect on frontal lobe activation (left middle frontal gyrus and orbital-frontal cortex) but exhibited no effect on grey matter volume.","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Espin', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Haussmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Matthes', 'Affiliation': 'Department of Psychiatry and Psychotherapy, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Donix', 'Affiliation': 'Department of Psychiatry and Psychotherapy, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Haehner', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-215257']
1689,35065922,"Community-based, cluster-randomized pilot trial of a cardiovascular mHealth intervention: Rationale, design, and baseline findings of the FAITH! Trial.","BACKGROUND


Compared to whites, African-Americans have lower prevalence of ideal cardiovascular health (CVH) based on the American Heart Association Life's Simple 7 (LS7). These CVH inequities have worsened during the COVID-19 pandemic. Ideal LS7 health-promoting behaviors and biological risk factors (eg, diet, blood pressure) are associated with improved CVH outcomes. The FAITH! (Fostering African-American Improvement in Total Health) App, a community-informed, mobile health (mHealth) intervention, previously demonstrated significant improvements in LS7 components among African-Americans, suggesting that mHealth interventions may be effective in improving CVH. This paper presents the FAITH! Trial design, baseline findings, and pandemic-related lessons learned.
METHODS


Utilizing a community-based participatory research approach, this study assessed the feasibility/preliminary efficacy of a refined FAITH! App for promoting LS7 among African-Americans in faith communities using a cluster, randomized controlled trial. Participants received the FAITH! App (immediate intervention) or were assigned to a delayed intervention comparator group. Baseline data were collected via electronic surveys and health assessments. Primary outcomes are change in LS7 score from baseline to 6-months post-intervention and app engagement/usability.
RESULTS


Of 85 enrolled individuals, 76 completed baseline surveys/health assessments, for a participation rate of 89% (N = 34 randomized to the immediate intervention, N = 42 to delayed intervention). At baseline, participants were predominantly female (54/76, 71%), employed (56/76, 78%) and of high cardiometabolic risk (72/76, 95% with hypertension and/or overweight/obesity) with mean LS7 scores in the poor range (6.8, SD = 1.9).
CONCLUSIONS


The FAITH! Trial recruitment was feasible, and its results may inform the use of mHealth tools to increase ideal CVH among African-Americans.",2022,"App, a community-informed, mobile health (mHealth) intervention, previously demonstrated significant improvements in LS7 components among African-Americans, suggesting mHealth interventions may be effective in improving CVH.","['Fostering African-American Improvement in Total Health', 'African-Americans', 'African-Americans in faith communities', 'Of 85', 'enrolled individuals, 76 completed baseline surveys/health assessments, for a participation rate of 89% (N=34 randomized to immediate intervention, N=42 to delayed intervention', 'participants were predominantly female (54/76, 71%), employed (56/76, 78%) and of high cardiometabolic risk (72/76, 95% with hypertension and/or overweight/obesity) with mean LS7 scores in the poor range (6.8, SD=1.9']","['refined FAITH', 'FAITH']","['change in LS7 score from baseline to 6-months post-intervention and app engagement/usability', 'LS7 components']","[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",85.0,0.170804,"App, a community-informed, mobile health (mHealth) intervention, previously demonstrated significant improvements in LS7 components among African-Americans, suggesting mHealth interventions may be effective in improving CVH.","[{'ForeName': 'LaPrincess C', 'Initials': 'LC', 'LastName': 'Brewer', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic College of Medicine, Rochester, MN; Center for Health Equity and Community Engagement Research, Mayo Clinic, Rochester, MN. Electronic address: brewer.laprincess@mayo.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Jenkins', 'Affiliation': 'Division of Clinical Trials and Biostatistics, Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Sharonne N', 'Initials': 'SN', 'LastName': 'Hayes', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Kumbamu', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Hue-Man Partnership, Minneapolis, MN.'}, {'ForeName': 'Lora E', 'Initials': 'LE', 'LastName': 'Burke', 'Affiliation': 'School of Nursing, Department of Health and Community Systems, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cooper', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Christi A', 'Initials': 'CA', 'LastName': 'Patten', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic College of Medicine, Rochester, MN.'}]",American heart journal,['10.1016/j.ahj.2022.01.009']
1690,35068018,Digital insertion of Foley catheter 16F versus 22F versus 28F in unripe cervix labor induction: A randomized trial.,"AIM


To explore digital insertion in dorsal recumbent position of 16F, 22F, or 28F catheter bores on insertion failure, duration, and pain in unripe cervix labor induction.
METHODS


A randomized trial was performed in a University hospital in Malaysia. Term women scheduled for labor induction, Bishop score ≤ 5, singleton, cephalic presentation, intact membrane, and reassuring pre-induction fetal heart rate tracing were recruited. Women with known gross fetal anomaly, allergy to latex and inability to consent or language difficulty were excluded. Participants were randomized to 16F, 22F, or 28F Foley catheter. Primary outcome was insertion failure and main secondary outcomes were insertion duration and pain (assessed by a Visual Numerical Rating Scale [VNRS] 0-10, higher score more pain). Analysis is done by analysis of variance (ANOVA), Kruskal-Wallis, and chi square test across the three arms and by t test and Mann-Whitney U test for pair wise comparisons.
RESULTS


One hundred twenty-seven participants' data were analyzed. The insertion failure 7/43(16%) versus 4/42(10%) versus 5/42(12%), p = 0.64, insertion duration median [IQR] 2.8 [1.8-4.8] versus 2.8 [1.7-3.7] versus 2.8 [1.7-4.3] min, p = 0.68 and insertion pain VNRS mean {SD} 4.2 {2.5} versus 3.4 {2.3} versus 3.6 {2.2}, p = 0.26, insertion to delivery interval 26.0 {9.7} versus 25.6 {9.1} versus 22.8 {7.4} h, p = 0.45, and spontaneous vaginal delivery 20/43 (45%) versus 23/42(55%) versus 25/42(60%), p = 0.48 for 16F versus 22F versus 28F arms, respectively. Pairwise comparisons were not different.
CONCLUSION


Foley catheter 16F versus 22F versus 28F resulted in similar digital insertion performance in the dorsal recumbent position for unripe cervix labor induction.
CLINICAL TRIAL REGISTRATION


https://doi.org/10.1186/ISRCTN21224268.",2022,Primary outcome was insertion failure and main secondary outcomes were insertion duration and pain,"['unripe cervix labor induction', 'University hospital in Malaysia', ""One hundred twenty-seven participants' data were analyzed"", 'Women with known gross fetal anomaly, allergy to latex and inability to consent or language difficulty were excluded', 'Term women scheduled for labor induction, Bishop score\u2009≤\u20095, singleton, cephalic presentation, intact membrane, and reassuring pre-induction fetal heart rate tracing were recruited']","['28F Foley catheter', 'Foley catheter 16F versus 22F versus 28F']","['Visual Numerical Rating Scale [VNRS] 0-10, higher score more pain', 'insertion failure', 'insertion failure, duration, and pain', 'insertion duration and pain', 'spontaneous vaginal delivery']","[{'cui': 'C0457226', 'cui_str': 'Uneffaced cervix'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0577628', 'cui_str': 'Allergy to latex'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0564213', 'cui_str': 'Difficulty using language'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0426199', 'cui_str': 'Intact membranes'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}]",127.0,0.363887,Primary outcome was insertion failure and main secondary outcomes were insertion duration and pain,"[{'ForeName': 'Boon K', 'Initials': 'BK', 'LastName': 'Lim', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Rohaida', 'Initials': 'R', 'LastName': 'Zakaria', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Jesrine G S', 'Initials': 'JGS', 'LastName': 'Hong', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siti Z', 'Initials': 'SZ', 'LastName': 'Omar', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Sofiah', 'Initials': 'S', 'LastName': 'Sulaiman', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Peng C', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.15157']
1691,35066211,Home-Based Hematopoietic Cell Transplantation in the United States.,"Patients undergoing allogeneic (allo) and autologous (auto) hematopoietic cell transplantation (HCT) require extensive hospitalizations or daily clinic visits for the duration of their transplantation. Home HCT, wherein patients live at home and providers make daily trips to the patient's residence to perform assessments and deliver any necessary interventions, may enhance patient quality of life and improve outcomes. We conducted the first study of home HCT in the United States to evaluate this model in the US healthcare setting and to determine the effect on clinical outcomes and quality of life. This case-control study evaluated patients who received home HCT at Duke University in Durham, North Carolina, from November 2012 to March 2018. Each home HCT patient was matched with 2 controls from the same institution who had received standard treatment based on age, disease, and type of transplant for outcomes comparison. Clinical outcomes were abstracted from electronic health records, and quality of life was assessed via Functional Assessment of Cancer Therapy-Bone Marrow Transplant. Clinical outcomes were compared with Student's t-test or Fisher's exact test (continuous variables) or chi-square test (categorical variables). Quality of life scores were compared using the Student t-test. All analyses used a significance threshold of 0.05. Twenty-five patients received home HCT, including 8 allos and 17 autos. Clinical outcomes were not significantly different between the home HCT patients and their matched controls; home HCT patients had decreased incidence of relapse within 1 year of transplantation. Pre-HCT quality of life was well preserved for autologous home HCT patients. This Phase I study demonstrated that home HCT can be successfully implemented in the United States. There was no evidence that home HCT outcomes were inferior to standard-of-care treatment, and patients undergoing autologous home HCT were able to maintain their quality of life. A Phase II randomized trial of home versus standard HCT is currently underway to better compare outcomes and costs.",2022,Clinical outcomes were not significantly different between the home HCT patients and their matched controls; home HCT patients had decreased incidence of relapse within one year of transplant (Table 1).,"['Patients undergoing', 'patients who received home HCT at Duke University in Durham, NC from November 2012 to March 2018']","['allogeneic (allo) and autologous (auto) hematopoietic cell transplantation (HCT', 'Home HCT', 'home vs. standard HCT']","['Pre-HCT quality of life', 'incidence of relapse', 'Quality of life scores', 'electronic health records and quality of life', 'quality of life', 'clinical outcomes and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C1512090', 'cui_str': 'Dukes staging system'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0454851', 'cui_str': 'Durham'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0515417,Clinical outcomes were not significantly different between the home HCT patients and their matched controls; home HCT patients had decreased incidence of relapse within one year of transplant (Table 1).,"[{'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Sung', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina. Electronic address: anthony.sung@duke.edu.'}, {'ForeName': 'Vinay K', 'Initials': 'VK', 'LastName': 'Giri', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina; Stanford Department of Internal Medicine, Stanford, California.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Krista Rowe', 'Initials': 'KR', 'LastName': 'Nichols', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Meagan V', 'Initials': 'MV', 'LastName': 'Lew', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Bohannon', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Sin-Ho', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Dalton', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Bush', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Jolien', 'Initials': 'J', 'LastName': 'Van Opstal', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Artica', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Messina', 'Affiliation': 'Division of Infectious Diseases, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Shelby', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Frith', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Lassiter', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina; Clinical Nurse Specialist, Division of Hematologic Malignancies and Cellular Therapy, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Burleson', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Leonard', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Ashley S', 'Initials': 'AS', 'LastName': 'Potter', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Taewoong', 'Initials': 'T', 'LastName': 'Choi', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Cristina J', 'Initials': 'CJ', 'LastName': 'Gasparetto', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Mitchell E', 'Initials': 'ME', 'LastName': 'Horwitz', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Gwynn D', 'Initials': 'GD', 'LastName': 'Long', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Lopez', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Sarantopoulos', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Nelson J', 'Initials': 'NJ', 'LastName': 'Chao', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke University, Durham, North Carolina.'}]",Transplantation and cellular therapy,['10.1016/j.jtct.2022.01.015']
1692,35067939,Growing Memories: Coaching mothers in elaborative reminiscing with toddlers benefits adolescents' turning-point narratives and wellbeing.,"INTRODUCTION


Parental elaborative reminiscing supports young children's autobiographical memory, narrative, and socioemotional skills.
OBJECTIVE


This study is an adolescent follow-up of a reminiscing intervention in which 115 primary-caregiver mothers of toddlers were randomly assigned to a control group (n = 59) or to receive training in elaborative reminiscing (n = 56) for the next year.
METHOD


At age 15, 93 of the now-adolescents (81%) were invited to narrate a turning point in their lives and to report on their personality traits and well-being. Turning-point narratives were coded for causal coherence (connections between past events and present self) and thematic coherence (elaboration and resolutions).
RESULTS


Adolescents whose mothers were in the intervention group told more causally coherent turning-point narratives and reported fewer emotional problems than control participants, covarying for baseline measures and personality traits.
CONCLUSION


Maternal elaborative reminiscing in early childhood appears to have long-term benefits for adolescents' causal coherence in turning-point narratives and well-being.",2022,"Adolescents whose mothers were in the training group told more causally coherent turning-point narratives and reported fewer emotional problems than control participants, covarying for baseline measures and personality traits.","['At age 15, 93 of the now-adolescents (81%) were invited to narrate a turning point in their lives and to report on their personality traits and well-being', '115 primary-caregiver mothers of toddlers']","['control group (n = 59) or to receive training in elaborative reminiscing', 'Parental elaborative reminiscing']","['Maternal elaborative reminiscing', 'emotional problems']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0233849', 'cui_str': 'Character trait finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}]",115.0,0.0560549,"Adolescents whose mothers were in the training group told more causally coherent turning-point narratives and reported fewer emotional problems than control participants, covarying for baseline measures and personality traits.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Mitchell', 'Affiliation': 'Psychology Department, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Reese', 'Affiliation': 'Psychology Department, University of Otago, Dunedin, New Zealand.'}]",Journal of personality,['10.1111/jopy.12703']
1693,35082352,The influence of myofascial release on pain and selected indicators of flat foot in adults: a controlled randomized trial.,"Flat foot pain is a common complaint that requires therapeutic intervention. Currently, myofascial release techniques are often used in the therapy of musculoskeletal disorders. A group of 60 people suffering from flat feet with associated pain. Patients were assigned to four groups (15 people each): MF-myofascial release, E-the exercise program, MFE-myofascial release and the exercise program, C-no intervention. The rehabilitation program lasted 4 weeks. The NRS scale was used to examine pain intensity and FreeMed ground reaction force platform was used to examine selected static and dynamic foot indicators. Statistically significant pain reduction was obtained in all research. A static test of foot load distribution produced statistically significant changes only for selected indicators. In the dynamic test, statistically significant changes were observed for selected indicators, only in the groups subjected to therapeutic intervention. Most such changes were observed in the MF group. In the dynamic test which assessed the support phase of the foot, statistically significant changes were observed only for selected subphases. Most such changes were observed in the MFE group. Both exercise and exercise combined with myofascial release techniques, and especially myofascial release techniques alone, significantly reduce pain in a flat foot. This study shows a limited influence of both exercises and myofascial release techniques on selected static and dynamic indicators of a flat foot.",2022,Statistically significant pain reduction was obtained in all research.,"['60 people suffering from flat feet with associated pain', 'adults']","['exercise and exercise combined with myofascial release techniques', 'MF-myofascial release, E-the exercise program, MFE-myofascial release and the exercise program, C-no intervention']","['pain reduction', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016202', 'cui_str': 'Flatfeet'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",60.0,0.00737444,Statistically significant pain reduction was obtained in all research.,"[{'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Bac', 'Affiliation': 'Faculty of Motor Rehabilitation, The Bronisław Czech, University of Physical Education, al. Jana Pawła II 78, 31-571, Krakow, Poland. aneta.bac@awf.krakow.pl.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Kaczor', 'Affiliation': 'Faculty of Motor Rehabilitation, The Bronisław Czech, University of Physical Education, al. Jana Pawła II 78, 31-571, Krakow, Poland.'}, {'ForeName': 'Szymon', 'Initials': 'S', 'LastName': 'Pasiut', 'Affiliation': 'Faculty of Motor Rehabilitation, The Bronisław Czech, University of Physical Education, al. Jana Pawła II 78, 31-571, Krakow, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ścisłowska-Czarnecka', 'Affiliation': 'Faculty of Motor Rehabilitation, The Bronisław Czech, University of Physical Education, al. Jana Pawła II 78, 31-571, Krakow, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Jankowicz-Szymańska', 'Affiliation': 'Faculty of Health Science, University of Applied Science in Tarnow, Tarnów, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Filar-Mierzwa', 'Affiliation': 'Faculty of Motor Rehabilitation, The Bronisław Czech, University of Physical Education, al. Jana Pawła II 78, 31-571, Krakow, Poland.'}]",Scientific reports,['10.1038/s41598-022-05401-w']
1694,35080598,Maintenance of Wellness in Patients With Obsessive-Compulsive Disorder Who Discontinue Medication After Exposure/Response Prevention Augmentation: A Randomized Clinical Trial.,"Importance


Serotonin reuptake inhibitors (SRIs) are the only medications approved for obsessive-compulsive disorder (OCD), yet most patients taking SRIs exhibit significant symptoms. Adding exposure/response prevention (EX/RP) therapy improves symptoms, but it is unknown whether patients maintain wellness after discontinuing SRIs.
Objective


To assess whether patients with OCD who are taking SRIs and have attained wellness after EX/RP augmentation can discontinue their SRI with noninferior outcomes compared with those who continue their SRI therapy.
Design, Setting, and Participants


A 24-week, double-blind, randomized clinical trial was performed from May 3, 2013, to June 25, 2018. The trial took place at US academic medical centers. Participants included 137 adults with a principal diagnosis of OCD (≥1 year) who were taking an SRI (≥12 weeks), had at least moderate symptoms (defined as Yale-Brown Obsessive-Compulsive Scale [Y-BOCS] score ≥18 points), and received as many as 25 sessions of EX/RP therapy. Those who attained wellness (Y-BOCS score ≤14 points; 103 patients [75.2%]) were study eligible. Data were analyzed from June 29, 2019, to October 2, 2021.
Intervention


Participants were randomly assigned either to receive taper to placebo (taper group) or to continue their SRI (continuation group) and monitored for 24 weeks.
Main Outcome and Measures


The Y-BOCS score (range, 0-40 points) was the primary outcome; the Hamilton Depression Rating Scale (HDRS; range, 0-52 points) and the Quality-of-Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF; range, 0%-100%) scores were secondary outcomes. Outcomes were assessed at 8 time points by independent evaluators who were blinded to randomization. The taper regimen was hypothesized to be noninferior to continuation at 24 weeks using a 1-sided α value of .05.
Results


A total of 101 patients (mean [SD] age, 31.0 [11.2] years; 55 women [54.5%]) participated in the trial: 51 patients (50.5%) in the taper group and 50 patients (49.5%) in the continuation group. At 24 weeks, patients in the taper group had noninferior results compared with patients in the continuation group (mean [SD] Y-BOCS score: taper group, 11.47 [6.56] points; continuation group: 11.51 [5.97] points; difference, -0.04 points; 1-sided 95% CI, -∞ to 2.09 points [below the noninferiority margin of 3.0 points]; mean [SD] HDRS score: taper group, 5.69 [3.84] points; continuation group, 4.61 [3.46] points; difference, 1.08 points; 1-sided 95% CI, -∞ to 2.28 points [below the noninferiority margin of 2.5 points]; mean [SD] Q-LES-Q-SF score: taper group, 68.01% [15.28%]; continuation group, 70.01% [15.59%]; difference, 2.00%; 1-sided 95% CI, -∞ to 6.83 [below the noninferiority margin of 7.75]). However, the taper group had higher rates of clinical worsening (23 of 51 [45%] vs 12 of 50 [24%]; P = .04).
Conclusions and Relevance


Results of this randomized clinical trial show that patients with OCD who achieve wellness after EX/RP therapy could, on average, discontinue their SRI with noninferior outcomes compared with those who continued their SRI. Those who tapered the SRI had higher clinical worsening rates. Future research should evaluate if SRI half-life alters these rates.
Trial Registration


ClinicalTrials.gov Identifier: NCT01686087.",2022,"At 24 weeks, patients in the taper group had noninferior results compared with patients in the continuation group (mean [SD] Y-BOCS score: taper group, 11.47","['Those who attained wellness (Y-BOCS score ≤14 points; 103 patients [75.2%]) were study eligible', 'Participants included 137 adults with a principal diagnosis of OCD (≥1 year) who were taking an SRI (≥12 weeks), had at least moderate symptoms (defined as Yale-Brown Obsessive-Compulsive Scale [Y-BOCS] score ≥18 points), and received as many as 25 sessions of EX/RP therapy', 'patients with OCD who are taking SRIs', 'patients maintain wellness after discontinuing SRIs', 'patients with OCD', 'Patients With Obsessive-Compulsive Disorder', '101 patients (mean [SD] age, 31.0 [11.2] years; 55 women [54.5%]) participated in the trial: 51 patients (50.5%) in the taper group and 50 patients (49.5%) in the continuation group']","['Serotonin reuptake inhibitors (SRIs', 'placebo (taper group) or to continue their SRI (continuation group) and monitored for 24 weeks', 'Discontinue Medication', 'Adding exposure/response prevention (EX/RP) therapy']","['Hamilton Depression Rating Scale (HDRS; range, 0-52 points) and the Quality-of-Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF; range, 0%-100%) scores', 'rates of clinical worsening', 'Y-BOCS score']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0162758', 'cui_str': 'Serotonin uptake inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",137.0,0.539375,"At 24 weeks, patients in the taper group had noninferior results compared with patients in the continuation group (mean [SD] Y-BOCS score: taper group, 11.47","[{'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Helen Blair', 'Initials': 'HB', 'LastName': 'Simpson', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Gallagher', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Wheaton', 'Affiliation': 'New York State Psychiatric Institute, New York.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Gershkovich', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Huppert', 'Affiliation': 'The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Imms', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Raphael B', 'Initials': 'RB', 'LastName': 'Campeas', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Cahill', 'Affiliation': 'University of Wisconsin, Milwaukee.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'DiChiara', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Tsao', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Puliafico', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chazin', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Asnaani', 'Affiliation': 'Department of Psychology, University of Utah, Salt Lake City.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'Rutgers University/Biomedical Health Sciences, New Brunswick, New Jersey.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Tyler', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Shari A', 'Initials': 'SA', 'LastName': 'Steinman', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Sanches-LaCay', 'Affiliation': 'New York State Psychiatric Institute, New York.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Capaldi', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ívar', 'Initials': 'Í', 'LastName': 'Snorrason', 'Affiliation': 'New York State Psychiatric Institute, New York.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Turk-Karan', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Vermes', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Kalanthroff', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Pinto', 'Affiliation': 'Department of Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, The Zucker Hillside Hospital, Glen Oaks, New York.'}, {'ForeName': 'Gabriella E', 'Initials': 'GE', 'LastName': 'Hamlett', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Middleton', 'Affiliation': 'New York State Psychiatric Institute, New York.'}, {'ForeName': 'Chang-Gyu', 'Initials': 'CG', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York.'}, {'ForeName': 'Page E', 'Initials': 'PE', 'LastName': 'Van Meter', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Katechis', 'Affiliation': 'New York State Psychiatric Institute, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Department of Psychology, Southern Methodist University, Dallas, Texas.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2021.3997']
1695,35077956,Abstinence-contingent wage supplements to promote drug abstinence and employment: Post-intervention outcomes.,"BACKGROUND


Substance use disorder, unemployment, and poverty are interrelated problems that have not been addressed adequately by existing interventions. This study evaluated post-intervention effects of abstinence-contingent wage supplements on drug abstinence and employment.
METHODS


Unemployed adults enrolled in opioid agonist treatment were randomly assigned to an abstinence-contingent wage supplement group (n = 44) or a usual care control group (n = 47). All participants could work with an employment specialist throughout a 12-month intervention period. Those in the abstinence-contingent wage supplement group earned stipends for working with the employment specialist and, after gaining employment, abstinence-contingent wage supplements for working in their community job but had to provide opiate- and cocaine-negative urine samples to maximize pay. To assess post-intervention effects of abstinence-contingent wage supplements and compare those effects to during-intervention effects, we analyzed urine samples and self-reports every 3 months during the 12-month intervention and the 12-month post-intervention period.
RESULTS


During the intervention, abstinence-contingent wage supplement participants provided significantly more opiate- and cocaine-negative urine samples than usual care control participants; abstinence-contingent wage supplement participants were also significantly more likely to become employed and live out of poverty than usual care participants during intervention. During the post-intervention period, the abstinence-contingent wage supplement and usual care control groups had similar rates of drug abstinence, similar levels of employment, and similar proportions living out of poverty.
CONCLUSIONS


Long-term delivery of abstinence-contingent wage supplements can promote drug abstinence and employment, but many patients relapse to drug use and cease employment when wage supplements are discontinued.",2022,"During the post-intervention period, the abstinence-contingent wage supplement and usual care control groups had similar rates of drug abstinence, similar levels of employment, and similar proportions living out of poverty.
","['All participants could work with an employment specialist throughout a 12-month intervention period', 'Unemployed adults enrolled in opioid agonist treatment']","['abstinence-contingent wage supplement group (n\xa0=\xa044) or a usual care control group', 'abstinence-contingent wage supplements']","['opiate- and cocaine-negative urine samples', 'likely to become employed and live out of poverty']","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0036064', 'cui_str': 'Salaries'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",47.0,0.0215545,"During the post-intervention period, the abstinence-contingent wage supplement and usual care control groups had similar rates of drug abstinence, similar levels of employment, and similar proportions living out of poverty.
","[{'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Novak', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'August F', 'Initials': 'AF', 'LastName': 'Holtyn', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Forrest', 'Initials': 'F', 'LastName': 'Toegel', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Jeannie-Marie', 'Initials': 'JM', 'LastName': 'Leoutsakos', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Silverman', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, United States. Electronic address: ksilverm@jhmi.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2022.109322']
1696,35080588,Driving Performance and Cannabis Users' Perception of Safety: A Randomized Clinical Trial.,"Importance


Expanding cannabis medicalization and legalization increases the urgency to understand the factors associated with acute driving impairment.
Objective


To determine, in a large sample of regular cannabis users, the magnitude and time course of driving impairment produced by smoked cannabis of different Δ9-tetrahydrocannabinol (THC) content, the effects of use history, and concordance between perceived impairment and observed performance.
Design, Setting, and Participants


This double-blind, placebo-controlled parallel randomized clinical trial took place from February 2017 to June 2019 at the Center for Medicinal Cannabis Research, University of California San Diego. Cannabis users were recruited for this study, and analysis took place between April 2020 and September 2021.
Interventions


Placebo or 5.9% or 13.4% THC cannabis smoked ad libitum.
Main Outcomes and Measures


The primary end point was the Composite Drive Score (CDS), which comprised key driving simulator variables, assessed prior to smoking and at multiple time points postsmoking. Additional measures included self-perceptions of driving impairment and cannabis use history.
Results


Of 191 cannabis users, 118 (61.8%) were male, the mean (SD) age was 29.9 (8.3) years, and the mean (SD) days of use in the past month was 16.7 (9.8). Participants were randomized to the placebo group (63 [33.0%]), 5.9% THC (66 [34.6%]), and 13.4% THC (62 [32.5%]). Compared with placebo, the THC group significantly declined on the Composite Drive Score at 30 minutes (Cohen d = 0.59 [95% CI, 0.28-0.90]; P < .001) and 1 hour 30 minutes (Cohen d = 0.55 [95% CI, 0.24-0.86]; P < .001), with borderline differences at 3 hours 30 minutes (Cohen d = 0.29 [95% CI, -0.02 to 0.60]; P = .07) and no differences at 4 hours 30 minutes (Cohen d = -0.03 [95% CI, -0.33 to 0.28]; P = .87). The Composite Drive Score did not differ based on THC content (likelihood ratio χ24 = 3.83; P = .43) or use intensity (quantity × frequency) in the past 6 months (likelihood ratio χ24 = 1.41; P = .49), despite postsmoking blood THC concentrations being higher in those with the highest use intensity. Although there was hesitancy to drive immediately postsmoking, increasing numbers (81 [68.6%]) of participants reported readiness to drive at 1 hour 30 minutes despite performance not improving from initial postsmoking levels.
Conclusions and Relevance


Smoking cannabis ad libitum by regular users resulted in simulated driving decrements. However, when experienced users control their own intake, driving impairment cannot be inferred based on THC content of the cigarette, behavioral tolerance, or THC blood concentrations. Participants' increasing willingness to drive at 1 hour 30 minutes may indicate a false sense of driving safety. Worse driving performance is evident for several hours postsmoking in many users but appears to resolve by 4 hours 30 minutes in most individuals. Further research is needed on the impact of individual biologic differences, cannabis use history, and administration methods on driving performance.
Trial Registration


ClinicalTrials.gov Identifier: NCT02849587.",2022,"The Composite Drive Score did not differ based on THC content (likelihood ratio χ24 = 3.83; P = .43) or use intensity (quantity × frequency) in the past 6 months (likelihood ratio χ24 = 1.41; P = .49), despite postsmoking blood THC concentrations being higher in those with the highest use intensity.","['191 cannabis users, 118 (61.8%) were male, the mean (SD) age was 29.9 (8.3) years, and the mean (SD) days of use in the past month was 16.7 (9.8', 'February 2017 to June 2019 at the Center for Medicinal Cannabis Research, University of California San Diego', 'Cannabis users were recruited for this study, and analysis took place between April 2020 and September 2021']","['placebo', 'Placebo', 'THC']","['postsmoking blood THC concentrations', 'self-perceptions of driving impairment and cannabis use history', 'Composite Drive Score', 'Composite Drive Score (CDS), which comprised key driving simulator variables, assessed prior to smoking and at multiple time points postsmoking', 'false sense of driving safety', 'THC content of the cigarette, behavioral tolerance, or THC blood concentrations']","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0813973', 'cui_str': 'Medical Cannabis'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}]",,0.452796,"The Composite Drive Score did not differ based on THC content (likelihood ratio χ24 = 3.83; P = .43) or use intensity (quantity × frequency) in the past 6 months (likelihood ratio χ24 = 1.41; P = .49), despite postsmoking blood THC concentrations being higher in those with the highest use intensity.","[{'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Marcotte', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego.'}, {'ForeName': 'Anya', 'Initials': 'A', 'LastName': 'Umlauf', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Grelotti', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'Sones', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Sobolesky', 'Affiliation': 'Department of Pathology, University of California San Diego, San Diego.'}, {'ForeName': 'Breland E', 'Initials': 'BE', 'LastName': 'Smith', 'Affiliation': 'Department of Pathology, University of California San Diego, San Diego.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Hoffman', 'Affiliation': 'Department of Pathology, University of California San Diego, San Diego.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Hubbard', 'Affiliation': 'Department of Pathology, University of California San Diego, San Diego.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Severson', 'Affiliation': 'Brainbaseline, Iowa City, Iowa.'}, {'ForeName': 'Marilyn A', 'Initials': 'MA', 'LastName': 'Huestis', 'Affiliation': 'Institute for Emerging Health Professions, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Grant', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Pathology, University of California San Diego, San Diego.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2021.4037']
1697,34893531,Hunger Training as a Self-regulation Strategy in a Comprehensive Weight Loss Program for Breast Cancer Prevention: A Randomized Feasibility Study.,"Weight losses >10% favorably modulate biomarkers of breast cancer risk but are not typically achieved by comprehensive weight loss programs, including the Diabetes Prevention Program (DPP). Combining the DPP with hunger training (HT), an evidence-based self-regulation strategy that uses self-monitored glucose levels to guide meal timing, has potential to enhance weight losses and cancer-related biomarkers, if proven feasible. This two-arm randomized controlled trial examined the feasibility of adding HT to the DPP and explored effects on weight and metabolic and breast cancer risk biomarkers. Fifty postmenopausal women [body mass index (BMI) >27 kg/m2)] at risk of breast cancer were randomized to the DPP+HT or DPP-only arm. Both arms followed a 16-week version of the DPP delivered weekly by a trained registered dietitian. Those in the DPP+HT also wore a continuous glucose monitor during weeks 4-6 of the program. Feasibility criteria were accrual rates >50%, retention rates >80%, and adherence to the HT protocol >75%. All a priori feasibility criteria were achieved. The accrual rate was 67%, retention rate was 81%, and adherence to HT was 90%. Weight losses and BMI reductions were significant over time as were changes in metabolic and breast cancer risk biomarkers but did not vary by group. This trial demonstrated that HT was feasible to add to comprehensive weight management program targeted toward postmenopausal women at high risk of breast cancer, though upon preliminary examination it does not appear to enhance weight loss or metabolic changes.
PREVENTION RELEVANCE


This study found that it was feasible to add a short glucose-guided eating intervention to a comprehensive weight management program targeting postmenopausal women at high risk of breast cancer. However, further development of this novel intervention as a cancer prevention strategy is needed.",2022,Weight losses and BMI reductions were significant over time as were changes in metabolic and breast cancer risk biomarkers but did not vary by group.,"['postmenopausal women at high risk of breast cancer', 'breast cancer prevention', 'Fifty postmenopausal women (BMI > 27 kg/m2) at risk of breast cancer']","['Hunger Training', 'HT', 'DPP with Hunger Training (HT', 'DPP+HT or DPP']","['metabolic and breast cancer risk biomarkers', 'weight and metabolic and breast cancer risk biomarkers', 'accrual rate', 'retention rate', 'Weight losses and BMI reductions']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C3874319', 'cui_str': 'At risk of breast cancer'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",50.0,0.0580129,Weight losses and BMI reductions were significant over time as were changes in metabolic and breast cancer risk biomarkers but did not vary by group.,"[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Schembre', 'Affiliation': 'Department of Family and Community Medicine, The University of Arizona, College of Medicine-Tucson, Tucson, Arizona.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Jospe', 'Affiliation': 'Department of Family and Community Medicine, The University of Arizona, College of Medicine-Tucson, Tucson, Arizona.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Bedrick', 'Affiliation': 'Department of Epidemiology and Biostatistics, The University of Arizona, Mel and Enid Zuckerman College of Public Health, Tucson, Arizona.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Abenaa M', 'Initials': 'AM', 'LastName': 'Brewster', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Erma', 'Initials': 'E', 'LastName': 'Levy', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Danika D', 'Initials': 'DD', 'LastName': 'Dirba', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Rachael W', 'Initials': 'RW', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Basen-Engquist', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-21-0298']
1698,35083924,Experiences of running a stratified medicine adaptive platform trial: Challenges and lessons learned from 10 years of the FOCUS4 trial in metastatic colorectal cancer.,"BACKGROUND


Complex innovative design trials are becoming increasingly common and offer potential for improving patient outcomes in a faster time frame. FOCUS4 was the first molecularly stratified trial in metastatic colorectal cancer and it remains one of the first umbrella trial designs to be launched globally. Here, we aim to describe lessons learned from delivery of the trial over the last 10 years.
METHODS


FOCUS4 was a Phase II/III molecularly stratified umbrella trial testing the safety and efficacy of targeted therapies in metastatic colorectal cancer. It used adaptive statistical methodology to decide which sub-trial should close early, and new therapies were added as protocol amendments. Patients with newly diagnosed metastatic colorectal cancer were registered, and central laboratory testing was used to stratify their tumour into molecular subtypes. Following 16 weeks of first-line therapy, patients with stable or responding disease were eligible for randomisation into either a molecularly stratified sub-trial (FOCUS4-B, C or D) or non-stratified FOCUS4-N. The primary outcome for all studies was progression-free survival comparing the intervention with active monitoring/placebo. At the close of the trial, feedback was elicited from all investigators through surveys and interviews and consolidated into a series of recommendations and lessons learned for the delivery of similar future trials.
RESULTS


Between January 2014 and October 2020, 1434 patients were registered from 88 UK hospitals. Of the 20 drug combinations that were explored for inclusion in the platform trial, three molecularly targeted sub-trials were activated: FOCUS4-D (February 2014-March 2016) evaluated AZD8931 in the BRAF-PIK3CA-RAS wildtype subgroup; FOCUS4-B (February 2016-July 2018) evaluated aspirin in the PIK3CA mutant subgroup and FOCUS4-C (June 2017-October 2020) evaluated adavosertib in the RAS+TP53 double mutant subgroup. FOCUS4-N was active throughout and evaluated capecitabine monotherapy versus a treatment break. A total of 361 (25%) registered patients were randomised into a sub-trial. Feedback on the experiences of delivery of FOCUS4 could be grouped into three main areas of challenge: funding/infrastructure, biomarker testing procedures and trial design efficiencies within which 20 recommendations are summarised.
CONCLUSION


Adaptive stratified medicine platform studies are feasible in common cancers but present challenges. Our stakeholder feedback has helped to inform how these trial designs can succeed and answer multiple questions efficiently, providing resource is adequate.",2022,"Our stakeholder feedback has helped to inform how these trial designs can succeed and answer multiple questions efficiently, providing resource is adequate.","['10 years of the FOCUS4 trial in metastatic colorectal cancer', 'A total of 361 (25%) registered patients', 'Between January 2014 and October 2020, 1434 patients were registered from 88 UK hospitals', 'February 2014-March 2016', 'metastatic colorectal cancer', 'patients with stable or responding disease were eligible for randomisation into either a molecularly stratified sub-trial (FOCUS4-B, C or D) or non-stratified FOCUS4-N', 'Patients with newly diagnosed metastatic colorectal cancer']","['placebo', 'FOCUS4-C', 'aspirin', 'FOCUS4-D', 'FOCUS4']",['progression-free survival'],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1434.0,0.338622,"Our stakeholder feedback has helped to inform how these trial designs can succeed and answer multiple questions efficiently, providing resource is adequate.","[{'ForeName': 'Louise C', 'Initials': 'LC', 'LastName': 'Brown', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': 'The Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fisher', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'Centre for Trials Research, Cardiff University and Velindre NHS Trust, Cardiff, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Seligmann', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Seymour', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Yates', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Richman', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Quirke', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Butler', 'Affiliation': 'Bristol Genetics Laboratory (BGL), Bristol, UK.'}, {'ForeName': 'Kaikeen', 'Initials': 'K', 'LastName': 'Shiu', 'Affiliation': 'University College Hospital, London, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Middleton', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Samuel', 'Affiliation': 'Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Wilson', 'Affiliation': 'The Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Maughan', 'Affiliation': 'MRC Oxford Institute for Radiation Oncology, Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/17407745211069879']
1699,34919884,"Quality of Life Implications of Dose-Escalated External Beam Radiation for Localized Prostate Cancer: Results of a Prospective Randomized Phase 3 Clinical Trial, NRG/RTOG 0126.","PURPOSE


External beam radiation therapy (EBRT) dose escalation has been tested in multiple prospective trials. However, the impact on patient reported outcomes (PROs) associated with higher doses of EBRT remain poorly understood. We sought to assess the differences in PROs between men treated with a dose of 70.2 Gy versus 79.2 Gy of EBRT for prostate cancer.
METHODS AND MATERIALS


The phase 3 clinical trial RTOG 0126 randomized 1532 patients with prostate cancer between March 2002 and August 2008 to 79.2 Gy over 44 fractions versus 70.2 Gy over 39 fractions. Eligible patients participated in the PRO data collection. PROs completed included the International Index of Erectile Function Questionnaire (IIEF), Functional Alterations due to Changes in Elimination (FACE), and the Spitzer Quality of Life Index (SQLI). The timepoints for the IIEF were collected pre-entry and at 6, 12, and 24 months. The FACE and SQLI were collected pre-entry and at 3, 6, 12, 18, and 24 months. The impact of EBRT dose to normal structures (penile bulb, rectum, and bladder) on PROs was also examined. Mixed effects models were used to analyze trends across time.
RESULTS


In total, 1144 patients completed baseline IIEF forms and of these, 56%, 64%, and 61% completed the IIEF at 6, 12, and 24 months, respectively; 1123 patients completed the FACE score at baseline and 50%, 61%, 73%, 61%, and 65% completed all 15 items for the FACE metric at timepoints of 3, 6, 12, 18, and 24 months, respectively. Erectile dysfunction at 12 months based on the single question was not significantly different between arms (38.1% for the standard dose radiation therapy arm vs 49.7% for the dose escalated radiation therapy arm; P = .051). Treatment arm (70.2 vs 79.2) had no significant impact on any PRO metrics measured across all collected domains. Comprehensive dosimetric analyses are presented and reveal multiple significant differences to regional organs at risk.
CONCLUSIONS


Compliance with PRO data collection was lower than anticipated in this phase 3 trial. Examining the available data, dose escalated EBRT did not appear to be associated with any detriment to PROs across numerous prospectively collected domains. These data, notwithstanding limitations, add to our understanding of the implications of EBRT dose escalation in prostate cancer. Furthermore, these results illustrate challenges associated with PRO data collection.",2022,"Examining the available data, dose escalated EBRT did not appear to be associated with any detriment to PROs across numerous prospectively collected domains.","['Localized Prostate Cancer', '1532 patients with prostate cancer between March 2002 and August 2008 to 79.2 Gy over 44 fractions versus 70.2 Gy over 39 fractions', 'men treated with a dose of 70.2 Gy versus 79.2 Gy of EBRT for prostate cancer', 'Eligible patients participated in the PRO data collection']","['EBRT', 'Dose-Escalated External Beam Radiation', 'External beam radiation therapy (EBRT']","['Erectile dysfunction', 'FACE score', 'PRO metrics', 'International Index of Erectile Function Questionnaire (IIEF), Functional Alterations due to Changes in Elimination (FACE), and the Spitzer Quality of Life Index (SQLI']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}]",1532.0,0.0650877,"Examining the available data, dose escalated EBRT did not appear to be associated with any detriment to PROs across numerous prospectively collected domains.","[{'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Hall', 'Affiliation': 'Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin. Electronic address: whall@mcw.edu.'}, {'ForeName': 'Snehal', 'Initials': 'S', 'LastName': 'Deshmukh', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Deborah W', 'Initials': 'DW', 'LastName': 'Bruner', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Michalski', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Purdy', 'Affiliation': 'University of California, Atlanata, Georgia.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Bosch', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Bahary', 'Affiliation': ""Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec.""}, {'ForeName': 'Maltibehn P', 'Initials': 'MP', 'LastName': 'Patel', 'Affiliation': 'Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Parliament', 'Affiliation': 'Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Lock', 'Affiliation': 'London Regional Cancer Program, London, Ontario, Canada.'}, {'ForeName': 'Harold Y', 'Initials': 'HY', 'LastName': 'Lau', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Souhami', 'Affiliation': 'McGill University, Montreal, Quebec.'}, {'ForeName': 'Scot A', 'Initials': 'SA', 'LastName': 'Fisher', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Kwok', 'Affiliation': 'University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Seider', 'Affiliation': 'University Hospitals Seidman Cancer Center, Cleveland, Ohio.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vigneault', 'Affiliation': ""CHU de Quebec-L'Hotel-Dieu de Québec, Montreal, Quebec.""}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Rosenthal', 'Affiliation': 'Sutter Cancer Centers Radiation Oncology Services-accruals under Radiologic Associates of Sacramento, Sacramento, California.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Gustafson', 'Affiliation': 'Beaumont Health, Southfield, Michigan.'}, {'ForeName': 'Hiram A', 'Initials': 'HA', 'LastName': 'Gay', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Pugh', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Movsas', 'Affiliation': 'Henry Ford Cancer Institute, Detroit, Michigan.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.07.004']
1700,35069013,"Psychological Status, Compliance, Serum Brain-Derived Neurotrophic Factor, and Nerve Growth Factor Levels of Patients with Depression after Augmented Mindfulness-Based Cognitive Therapy.","Objective


Mindfulness-based cognitive therapy (MBCT) is a cost-effective psychosocial program that prevents relapse/recurrence in major depression. The present study aimed to analyze the effects of augmented MBCT along with standard treatment dominated by pharmacotherapy on psychological state, compliance, brain-derived neurotrophic factor (BDNF), and nerve growth factor (NGF) expression levels in patients with depression.
Methods


A total of 160 eligible patients with depression in The First Affiliated Hospital of Zhengzhou University were included in this study. The study randomly assigned the patients to the experimental group ( n  = 80) and control group ( n  = 80). All participants were assessed with the questionnaires including the 17-item Hamilton Depression Rating Scale (HAMD-17), Rosenberg Self-esteem Scale (RSES), Self-Acceptance Questionnaire (SAQ), and Stigma Scale (Scale of Stigma in People with Mental Illness, SSPM). The serum levels of BDNF and NGF were detected by enzyme-linked immunosorbent assay (ELISA).
Results


After 8 weeks of treatment, the experimental group showed significant lower HAMD-17 score, higher RSES, and SAQ score, as well as lower SSPM score compared with the control group ( P  < 0.01). Furthermore, ELISA revealed that the serum levels of BDNF and NGF remarkably increased in the experimental group after treatment ( P  < 0.001).
Conclusions


Our data showed that augmented MBCT combined with pharmacotherapy contributed to improvement on patients' psychological state, compliance, and disease recurrence.",2022,"After 8 weeks of treatment, the experimental group showed significant lower HAMD-17 score, higher RSES, and SAQ score, as well as lower SSPM score compared with the control group ( P  < 0.01).","['160 eligible patients with depression in The First Affiliated Hospital of Zhengzhou University were included in this study', 'patients with depression']","['MBCT', 'MBCT combined with pharmacotherapy', 'Objective\n\n\nMindfulness-based cognitive therapy (MBCT']","['lower HAMD-17 score, higher RSES, and SAQ score', '17-item Hamilton Depression Rating Scale (HAMD-17), Rosenberg Self-esteem Scale (RSES), Self-Acceptance Questionnaire (SAQ), and Stigma Scale (Scale of Stigma in People with Mental Illness, SSPM', 'psychological state, compliance, brain-derived neurotrophic factor (BDNF), and nerve growth factor (NGF) expression levels', 'SSPM score', 'Psychological Status, Compliance, Serum Brain-Derived Neurotrophic Factor, and Nerve Growth Factor Levels', 'serum levels of BDNF and NGF', ""patients' psychological state, compliance, and disease recurrence""]","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0050133', 'cui_str': '9,10-anthraquinone'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}]",160.0,0.0169286,"After 8 weeks of treatment, the experimental group showed significant lower HAMD-17 score, higher RSES, and SAQ score, as well as lower SSPM score compared with the control group ( P  < 0.01).","[{'ForeName': 'Huirong', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province 450052, China.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'Office of Academic Studies, Xinxiang Medical University, Xinxiang, Henan Province 453003, China.'}, {'ForeName': 'Bailing', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province 450052, China.'}, {'ForeName': 'Junru', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province 450052, China.'}, {'ForeName': 'Xuhuang', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ""Department of Psychiatry, People's Hospital of Gongyi City, Gongyi, Henan Province 451299, China.""}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province 450052, China.'}]",Genetics research,['10.1155/2022/1097982']
1701,35044568,Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp.,"INTRODUCTION


Increased postprandial glucose (PPG) is associated with high glycated haemoglobin levels and is an independent risk factor for cardiovascular diseases. The aim of this study was to compare PPG increments in Asian versus non-Asian adults with type 2 diabetes (T2D), who were insulin-naïve or insulin-experienced, from the phase 3 insulin degludec/insulin aspart (IDegAsp) clinical trials.
METHODS


This was a post hoc analysis of data from 13 phase 3, randomised, parallel-group, open-label IDegAsp trials in patients with T2D. The pooled baseline clinical data were analysed for insulin-naïve and insulin-experienced groups; and each group was split into subgroups of Asian and non-Asian patients, respectively, and analysed accordingly. Baseline self-monitored blood glucose (SMBG) values at breakfast, lunch and the evening meal (before and 90 min after each meal) were used to assess PPG increments. The estimated differences in baseline SMBG increment between the Asian and non-Asian subgroups were analysed.
RESULTS


Clinical data from 4750 participants (insulin-naïve, n = 1495; insulin-experienced, n = 3255) were evaluated. In the insulin-naïve group, the postprandial SMBG increment was significantly greater in the Asian versus the non-Asian subgroup at breakfast (estimated difference 28.67 mg/dL, 95% confidence interval [CI] 18.35, 38.99; p < 0.0001), lunch (17.34 mg/dL, 95% CI 6.47, 28.21; p = 0.0018) and the evening meal (16.19 mg/dL, 95% CI 5.04, 27.34; p = 0.0045). In the insulin-experienced group, the postprandial SMBG increment was significantly greater in the Asian versus non-Asian subgroup at breakfast (estimated difference 13.81 mg/dL, 95% CI 9.19, 18.44; p < 0.0001) and lunch (29.18 mg/dL, 95% CI 24.22, 34.14; p < 0.0001), but not significantly different at the evening meal.
CONCLUSION


In this post hoc analysis, baseline PPG increments were significantly greater in Asian participants with T2D than in their non-Asian counterparts at all mealtimes, with the exception of the evening meal in insulin-experienced participants. Asian adults with T2D may benefit from the use of regimens that control PPG excursions.
CLINICAL TRIAL NUMBERS


NCT02762578, NCT01814137, NCT01513590, NCT01009580, NCT01713530, NCT02648217, NCT01045447, NCT01365507, NCT01045707, NCT01272193, NCT01059812, NCT01680341, NCT02906917.",2022,"In the insulin-naïve group, the postprandial SMBG increment was significantly greater in the Asian versus the non-Asian subgroup at breakfast (estimated difference 28.67 mg/dL, 95% confidence interval [CI] 18.35, 38.99; p < 0.0001), lunch (17.34 mg/","['Asian Versus Non-Asian Patients with Type 2 Diabetes', '4750 participants (insulin-naïve, n\u2009=\u20091495; insulin-experienced, n\u2009=\u20093255', 'patients with T2D', 'Asian versus non-Asian adults with type 2 diabetes (T2D), who were insulin-naïve or insulin-experienced, from the phase 3 insulin degludec/insulin aspart (IDegAsp) clinical trials', 'Asian adults with T2D']",[],"['baseline PPG increments', 'Postprandial Glucose Excursions', 'postprandial SMBG increment', 'baseline SMBG increment', 'Baseline self-monitored blood glucose (SMBG) values at breakfast, lunch and the evening meal']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0585040', 'cui_str': 'Evening meal'}]",4750.0,0.217984,"In the insulin-naïve group, the postprandial SMBG increment was significantly greater in the Asian versus the non-Asian subgroup at breakfast (estimated difference 28.67 mg/dL, 95% confidence interval [CI] 18.35, 38.99; p < 0.0001), lunch (17.34 mg/","[{'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, China-Japan Friendship Hospital, Beijing, 100029, China. ywying_1010@163.com.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Akhtar', 'Affiliation': 'Clinical, Medical and Regulatory Department, Novo Nordisk Pharma Gulf FZ-LLC, Dubai, United Arab Emirates.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Medical Research Centre, Warsaw, Poland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Haluzík', 'Affiliation': 'Institute for Clinical and Experimental Medicine and Charles University, Prague, Czech Republic.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Hirose', 'Affiliation': 'Toho University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Balamurali', 'Initials': 'B', 'LastName': 'Kalyanam', 'Affiliation': 'Novo Nordisk Service Centre India Private Ltd., Bangalore, India.'}, {'ForeName': 'Soumitra', 'Initials': 'S', 'LastName': 'Kar', 'Affiliation': 'Novo Nordisk Service Centre India Private Ltd., Bangalore, India.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Diabetes Centre, Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Gogas Yavuz', 'Affiliation': 'Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Ambika Gopalakrishnan', 'Initials': 'AG', 'LastName': 'Unnikrishnan', 'Affiliation': 'Chellaram Diabetes Institute, Pune, India.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-021-01196-7']
1702,35074248,"Five-Year Results of a Randomized, Controlled Trial of Collagenase Treatment Compared With Needle Fasciotomy for Dupuytren Contracture.","PURPOSE


Over the past decade, collagenase treatment and needle fasciotomy (NF) have gained widespread popularity in the treatment of Dupuytren contracture. This prospective study was designed to compare the results of these treatments in terms of clinical and patient-reported outcomes.
METHODS


A prospective, randomized, controlled trial included patients with a contracture of 20° or more in a single metacarpophalangeal joint. Patients were allocated to treatment with either NF or collagenase Clostridium histolyticum. The primary outcome was a reduction in the metacarpophalangeal joint contracture to less than 5°. Secondary outcomes included recurrence, the presence of Dupuytren cords, and changes in patient-reported outcomes. The participants were examined 5 years after the intervention.
RESULTS


The study cohort comprised 156 patients divided into 2 equally sized groups. After 5 years, data were collected from 143 (92 %) of the initially enrolled participants. The mean time for the clinical follow-up was 5.1 years. In the remaining cohort without a second procedure, 51% (23 patients) in the collagenase Clostridium histolyticum group and 47% (27 patients) in the NF group still had extension deficits of less than 5°. Among the participants with a successful initial procedure, the recurrence rate was 56% (36 patients) in the collagenase Clostridium histolyticum group and 45% (30 patients) in the NF group. There were no differences between the 2 treatments in regard to passive joint extension, reduction of contracture, range of motion, or patient-reported outcomes.
CONCLUSIONS


The 5-year outcomes for NF are similar to those for collagenase in terms of sustained correction, recurrence, presence of Dupuytren cords, and patient-reported outcomes for the treatment of metacarpophalangeal joint contractures.
TYPE OF STUDY/LEVEL OF EVIDENCE


Therapeutic I.",2022,"There were no differences between the 2 treatments in regard to passive joint extension, reduction of contracture, range of motion, or patient-reported outcomes.
","['patients with a contracture of 20° or more in a single metacarpophalangeal joint', '156 patients divided into 2 equally sized groups']","['NF or collagenase Clostridium histolyticum', 'needle fasciotomy (NF', 'Needle Fasciotomy', 'Collagenase Treatment']","['recurrence, the presence of Dupuytren cords, and changes in patient-reported outcomes', 'recurrence rate', 'mean time', '5-year outcomes', 'metacarpophalangeal joint contracture', 'passive joint extension, reduction of contracture, range of motion, or patient-reported outcomes', 'extension deficits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0025525', 'cui_str': 'Metacarpophalangeal joint structure'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0185188', 'cui_str': 'Division of fascia'}, {'cui': 'C0009053', 'cui_str': 'collagenase Clostridium histolyticum'}, {'cui': 'C0162745', 'cui_str': 'COLLAGENASE'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0013312', 'cui_str': ""Dupuytren's contracture""}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025525', 'cui_str': 'Metacarpophalangeal joint structure'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",156.0,0.136589,"There were no differences between the 2 treatments in regard to passive joint extension, reduction of contracture, range of motion, or patient-reported outcomes.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Byström', 'Affiliation': 'Department of Hand Surgery, Sahlgrenska University Hospital, Göteborg, Sweden; Department of Orthopaedics, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Electronic address: martin.bystrom@vgregion.se.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Ibsen Sörensen', 'Affiliation': 'Department of Hand Surgery, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Samuelsson', 'Affiliation': 'Department of Orthopaedics, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Orthopaedics, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Jan O', 'Initials': 'JO', 'LastName': 'Fridén', 'Affiliation': 'Department of Orthopaedics, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Swiss Paraplegic Centre, Nottwil, Switzerland.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Strömberg', 'Affiliation': 'Department of Orthopaedics, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Surgery and Orthopaedics, Alingsås Hospital, Alingsås, Sweden.'}]",The Journal of hand surgery,['10.1016/j.jhsa.2021.11.019']
1703,35074540,ABCDEF pulmonary rehabilitation program can improve the mid-term lung function of lung cancer patients after thoracoscopic surgery: A randomized controlled study.,"Background Pulmonary rehabilitation is recommended for most patients with lung diseases. However, some previous studies have shown that pulmonary rehabilitation has no obvious effect on short-term lung function in patients with lung cancer. Objective The purpose of this study was to evaluate the effect of the ABCDEF pulmonary rehabilitation program on lung cancer patients who have undergone surgery. Design This was a randomized controlled trial with repeated measures. Settings The study was conducted in the Cardiothoracic Surgery Department of a 4000-bed comprising training and research hospital from 2019 to 2020. Participants A total of 90 patients who underwent thoracoscopic pneumonectomy were divided into two groups of 45, using a completely randomized model. Methods Patients in the experimental group participated in an ABCDEF program (Acapella positive vibration pressure training, breathing exercise, cycling training, dance in the square, education, and follow-up) after surgery. In contrast, the regular care provided to the control group focused on breathing and expectoration guidance. The study outcomes were the first second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, 6 min walking distance, Borg score, incidence of postoperative complications, length of indwelling chest tube, and length of postoperative stay. Generalized estimating equation models were used to compare the changes in the outcomes between the groups over time. Results The ABCDEF pulmonary rehabilitation program for patients who underwent thoracoscopic pneumonectomy was found to be more effective in increasing lung function at 3 months after discharge (p<0.05). However, there was no statistically significant difference on the day of discharge (p>0.05). Exercise tolerance was different at both time points (p<0.05). The incidence of postoperative complications in the experimental group was lower than that in the control group (p<0.05). The length of postoperative stay in the experimental group was also shorter (p<0.05), however, the length of the indwelling chest tube was not significantly different between the intervention and control groups (p>0.05). Conclusions This study showed that the ABCDEF pulmonary rehabilitation program could effectively improve mid-term lung function and exercise tolerance in patients after thoracoscopic pneumonectomy, and reduce the incidence of postoperative complications along with the length of postoperative hospital stay.",2022,Results The ABCDEF pulmonary rehabilitation program for patients who underwent thoracoscopic pneumonectomy was found to be more effective in increasing lung function at 3 months after discharge (p<0.05).,"['patients with lung cancer', 'lung cancer patients after thoracoscopic surgery', 'Participants A total of 90 patients who underwent', 'lung cancer patients who have undergone surgery', 'patients with lung diseases', 'Cardiothoracic Surgery Department of a 4000-bed comprising training and research hospital from 2019 to 2020']","['ABCDEF program (Acapella positive vibration pressure training, breathing exercise, cycling training, dance in the square, education, and follow-up) after surgery', 'ABCDEF pulmonary rehabilitation program', ' Pulmonary rehabilitation', 'thoracoscopic pneumonectomy']","['mid-term lung function and exercise tolerance', 'incidence of postoperative complications', 'lung function', 'first second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, 6\xa0min walking distance, Borg score, incidence of postoperative complications, length of indwelling chest tube, and length of postoperative stay', 'length of postoperative stay', 'length of the indwelling chest tube', 'Exercise tolerance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0587505', 'cui_str': 'Cardiothoracic surgery department'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0521224', 'cui_str': 'Thoracoscopic pneumonectomy'}]","[{'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",90.0,0.00637327,Results The ABCDEF pulmonary rehabilitation program for patients who underwent thoracoscopic pneumonectomy was found to be more effective in increasing lung function at 3 months after discharge (p<0.05).,"[{'ForeName': 'Haoyu', 'Initials': 'H', 'LastName': 'Zou', 'Affiliation': ""Department of Nursing, Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha 410005, PR China.""}, {'ForeName': 'Yuelan', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': ""Department of Nursing, Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha 410005, PR China.""}, {'ForeName': 'Fanghua', 'Initials': 'F', 'LastName': 'Gong', 'Affiliation': ""Department of Nursing, Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha 410005, PR China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Medical College of Hunan Normal University, Changsha 410013, PR China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiothoracic, Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha 410005, PR China.""}, {'ForeName': 'Liuyi', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Medical College of Hunan Normal University, Changsha 410013, PR China. Electronic address: liuyizhang@hunnu.edu.cn.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2021.12.021']
1704,35074451,"Repetitive transcranial magnetic stimulation in treatment-seeking subjects with cocaine use disorder: A randomized, double-blind, sham-controlled trial.","BACKGROUND


Cocaine use disorder (CUD) is a chronic and relapsing brain disorder with no approved treatments. Repetitive transcranial magnetic stimulation (rTMS) has shown promising results in open label and single-blind studies, reducing cocaine craving and consumption. Although, large randomized, double-blind, controlled trials are still missing.
OBJECTIVE


This multi-center, randomized, double-blind, sham-controlled study was designed to evaluate the safety and efficacy of multiple sessions of active rTMS compared to sham stimulation in patients with CUD.
METHODS


rTMS (15 Hz, 2 daily sessions for 5 days/week,for a total of 20 stimulation sessions) was delivered over the left DLPFC for two weeks of continuous treatment followed by 12 weeks of maintenance (1 day/week, twice a day), in a double-blind, randomized sham-controlled design. Our primary outcomes included self-reported cue-induced craving and cocaine consumption, as measured by percentage of negative urine tests. Our secondary outcomes included: 1) changes in depressive symptoms; 2) changes in cocaine withdrawal symptoms; and 3) changes in self-reported days of cocaine use.
RESULTS


Forty-two outpatients with CUD were enrolled in the active rTMS group and 38 patients in the sham group. We observed a significant decrease in self-reported cue-induced cocaine craving and consumption in both the active rTMS and sham, whereas no main effect of treatment was found. However, the active rTMS group showed greater changes in depressive symptoms. The improvement on depressive symptomatology was particularly marked among patients receiving a total number of rTMS sessions greater than 40 and those reporting more severe depressive symptoms at baseline.
CONCLUSIONS


A significant improvement of CUD symptoms during active rTMS treatment was observed. However, we did not observe significant differences in cocaine craving and consumption between treatment groups, highlighting the complexity of factors contributing to CUD maintenance. A significant improvement in depressive symptoms was observed in favour of the active group. Clinical trial registration details:clinicaltrials.govidentifierNCT03333460.",2022,"We observed a significant decrease in self-reported cue-induced cocaine craving and consumption in both the active rTMS and sham, whereas no main effect of treatment was found.","['treatment-seeking subjects with cocaine use disorder', 'patients with CUD', 'rTMS', 'Forty-two outpatients with CUD were enrolled in the active rTMS group and 38 patients in the sham group']","['Repetitive transcranial magnetic stimulation (rTMS', 'Repetitive transcranial magnetic stimulation', 'active rTMS']","['severe depressive symptoms', 'depressive symptomatology', 'self-reported cue-induced craving and cocaine consumption, as measured by percentage of negative urine tests', 'self-reported cue-induced cocaine craving and consumption', 'cocaine craving and consumption', 'safety and efficacy', 'depressive symptoms', '1) changes in depressive symptoms; 2) changes in cocaine withdrawal symptoms; and 3) changes in self-reported days of cocaine use', 'CUD symptoms']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009178', 'cui_str': 'Cocaine withdrawal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",42.0,0.321957,"We observed a significant decrease in self-reported cue-induced cocaine craving and consumption in both the active rTMS and sham, whereas no main effect of treatment was found.","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Martinotti', 'Affiliation': 'Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy; Department of Pharmacy, Pharmacology and Postgraduate Medicine, University of Hertfordshire, Hatfield, UK; SRP Villa Maria Pia, Mental Health and Addiction Inpatient Unit, Rome, Italy. Electronic address: giovanni.martinotti@gmail.com.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Pettorruso', 'Affiliation': 'Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Montemitro', 'Affiliation': 'Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy; National Institute of Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, United States.'}, {'ForeName': 'Primavera Alessandra', 'Initials': 'PA', 'LastName': 'Spagnolo', 'Affiliation': 'National Institute of Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, United States; National Institute on Neurological Disorders and Stroke, Intramural Research Program, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Acuti Martellucci', 'Affiliation': 'Department of Medical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Di Carlo', 'Affiliation': 'Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Fanella', 'Affiliation': ""Addictive Disorder Outpatient Clinic 'La Promessa', Rome, Italy.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'di Giannantonio', 'Affiliation': 'Department of Neuroscience, Imaging and Clinical Sciences, ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2022.110513']
1705,34879711,Power and sample size calculations for cluster randomized trials with binary outcomes when intracluster correlation coefficients vary by treatment arm.,"BACKGROUND/AIMS


Generalized estimating equations are commonly used to fit logistic regression models to clustered binary data from cluster randomized trials. A commonly used correlation structure assumes that the intracluster correlation coefficient does not vary by treatment arm or other covariates, but the consequences of this assumption are understudied. We aim to evaluate the effect of allowing variation of the intracluster correlation coefficient by treatment or other covariates on the efficiency of analysis and show how to account for such variation in sample size calculations.
METHODS


We develop formulae for the asymptotic variance of the estimated difference in outcome between treatment arms obtained when the true exchangeable correlation structure depends on the treatment arm and the working correlation structure used in the generalized estimating equations analysis is: (i) correctly specified, (ii) independent, or (iii) exchangeable with no dependence on treatment arm. These formulae require a known distribution of cluster sizes; we also develop simplifications for the case when cluster sizes do not vary and approximations that can be used when the first two moments of the cluster size distribution are known. We then extend the results to settings with adjustment for a second binary cluster-level covariate. We provide formulae to calculate the required sample size for cluster randomized trials using these variances.
RESULTS


We show that the asymptotic variance of the estimated difference in outcome between treatment arms using these three working correlation structures is the same if all clusters have the same size, and this asymptotic variance is approximately the same when intracluster correlation coefficient values are small. We illustrate these results using data from a recent cluster randomized trial for infectious disease prevention in which the clusters are groups of households and modest in size (mean 9.6 individuals), with intracluster correlation coefficient values of 0.078 in the control arm and 0.057 in an intervention arm. In this application, we found a negligible difference between the variances calculated using structures (i) and (iii) and only a small increase (typically  < 5 % ) for the independent correlation structure (ii), and hence minimal effect on power or sample size requirements. The impact may be larger in other applications if there is greater variation in the ICC between treatment arms or with an additional covariate.
CONCLUSION


The common approach of fitting generalized estimating equations with an exchangeable working correlation structure with a common intracluster correlation coefficient across arms likely does not substantially reduce the power or efficiency of the analysis in the setting of a large number of small or modest-sized clusters, even if the intracluster correlation coefficient varies by treatment arm. Our formulae, however, allow formal evaluation of this and may identify situations in which variation in intracluster correlation coefficient by treatment arm or another binary covariate may have a more substantial impact on power and hence sample size requirements.",2022,"We develop formulae for the asymptotic variance of the estimated difference in outcome between treatment arms obtained when the true exchangeable correlation structure depends on the treatment arm and the working correlation structure used in the generalized estimating equations analysis is: (i) correctly specified, (ii) independent, or (iii) exchangeable with no dependence on treatment arm.",[],[],[],[],[],[],,0.122228,"We develop formulae for the asymptotic variance of the estimated difference in outcome between treatment arms obtained when the true exchangeable correlation structure depends on the treatment arm and the working correlation structure used in the generalized estimating equations analysis is: (i) correctly specified, (ii) independent, or (iii) exchangeable with no dependence on treatment arm.","[{'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Kennedy-Shaffer', 'Affiliation': 'Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}]","Clinical trials (London, England)",['10.1177/17407745211059845']
1706,34991562,Effects of treatment with SGLT-2 inhibitors on arginine-related cardiovascular and renal biomarkers.,"BACKGROUND


In patients with type 2 diabetes (T2D) sodium-glucose cotransporter 2 (SGLT-2) inhibitors improve glycaemic control as well as cardiovascular and renal outcomes. Their effects on L-arginine (Arg) related risk markers asymmetric and symmetric dimethylarginine (ADMA and SDMA) and the protective biomarker L-homoarginine (hArg) linking T2D to cardiovascular and renal disease have not yet been reported.
METHODS


Plasma and 24-h urine samples taken before and after 6 weeks of treatment were available from two prospective, randomized, double-blind, placebo-controlled, cross-over trials with empagliflozin (71 patients analyzed, NCT02471963) and dapagliflozin (59 patients analyzed, NCT02383238). In these samples, concentrations of hArg, Arg, ADMA, SDMA, and creatinine were determined by liquid-chromatography coupled to tandem mass-spectrometry. Additionally, intraindividual changes of the biomarkers in plasma were correlated with intraindividual changes of clinical parameters.
RESULTS


Treatment with empagliflozin and dapagliflozin was associated with a reduction of plasma hArg by 17.5% and 13.7% (both p < 0.001), respectively, and increase in plasma SDMA concentration of 6.7% and 3.6%, respectively (p < 0.001 and p < 0.05), while plasma Arg and ADMA concentrations were not significantly altered. 24-h urinary excretion of ADMA was reduced by 15.2% after treatment with empagliflozin (p < 0.001) but not after dapagliflozin treatment, while excretion of the other markers was not significantly altered. Renal clearance of SDMA was reduced by 9.1% and 3.9% for both drugs (both p < 0.05). A reduction in ADMA clearance was observable after empagliflozin treatment only (- 15.5%, p < 0.001), but not after dapagliflozin. Renal clearance of hArg and Arg was not significantly altered. Treatment effects on L-arginine related biomarkers were not constantly correlated with effects on glycated hemoglobin, fasting plasma glucose, body mass index, and systolic blood pressure.
CONCLUSIONS


Treatment with SGLT-2 inhibitors has divergent effects on Arg-related biomarkers and could affect risk estimates associated with these markers. The observed effects are unlikely to explain the known cardiovascular and renal benefits of treatment with empagliflozin or dapagliflozin but still may indicate new therapeutic approaches in patients treated with SGLT-2 inhibitors. Trial registration http://www.clinicaltrials.gov : NCT02471963 (registered 15th June 2015, retrospectively registered) and NCT02383238.",2022,"Treatment effects on L-arginine related biomarkers were not constantly correlated with effects on glycated hemoglobin, fasting plasma glucose, body mass index, and systolic blood pressure.
","['patients treated with SGLT-2 inhibitors', 'patients with type 2 diabetes (T2D']","['placebo', 'empagliflozin', 'sodium-glucose cotransporter 2 (SGLT-2) inhibitors', 'dapagliflozin', 'empagliflozin and dapagliflozin', 'empagliflozin or dapagliflozin', 'SGLT-2 inhibitors']","['reduction of plasma hArg', 'glycated hemoglobin, fasting plasma glucose, body mass index, and systolic blood pressure', '24-h urinary excretion of ADMA', 'Renal clearance of hArg', 'plasma Arg and ADMA concentrations', 'ADMA clearance', 'concentrations of hArg, Arg, ADMA, SDMA, and creatinine', 'L-arginine (Arg) related risk markers asymmetric and symmetric dimethylarginine (ADMA and SDMA', 'Renal clearance of SDMA', 'plasma SDMA concentration', 'arginine-related cardiovascular and renal biomarkers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019877', 'cui_str': 'Homoarginine'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0067305', 'cui_str': ""N,N'-dimethylarginine""}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",,0.0653156,"Treatment effects on L-arginine related biomarkers were not constantly correlated with effects on glycated hemoglobin, fasting plasma glucose, body mass index, and systolic blood pressure.
","[{'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Gessner', 'Affiliation': 'Institute of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Fahrstr. 17, 91054, Erlangen, Germany. arne.gessner@fau.de.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gemeinhardt', 'Affiliation': 'Institute of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Fahrstr. 17, 91054, Erlangen, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Bosch', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Kannenkeril', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Staerk', 'Affiliation': 'Institute of Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mayr', 'Affiliation': 'Institute of Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Fromm', 'Affiliation': 'Institute of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Fahrstr. 17, 91054, Erlangen, Germany.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Schmieder', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Renke', 'Initials': 'R', 'LastName': 'Maas', 'Affiliation': 'Institute of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Fahrstr. 17, 91054, Erlangen, Germany.'}]",Cardiovascular diabetology,['10.1186/s12933-021-01436-x']
1707,35040001,A Longitudinal RCT of P-ESDM With and Without Parental Mindfulness Based Stress Reduction: Impact on Child Outcomes.,"This randomized controlled trial (NCT03889821) examined Mindfulness Based Stress Reduction (MBSR) in conjunction with the Parent-implemented Early Start Denver Model (P-ESDM). A previous report described improved metrics of parental distress (Weitlauf et al. in Pediatrics 145(Supplement 1):S81-S92, 2020). This manuscript examines child outcomes. 63 children with ASD (< 36 months) and their parents received 12 P-ESDM sessions. Half of parents also received MBSR. Longitudinal examination of whole sample means revealed modest improvements in autism severity, cognitive, and adaptive skills. There was not a significant time × group interaction for children whose parents received MBSR. Future work should examine more proximal markers of child or dyadic change to enhance understanding of the impact of providing direct treatment for parents as part of early intervention initiatives.",2022,There was not a significant time × group interaction for children whose parents received MBSR.,['63 children with ASD (<\u200936\xa0months) and their parents received 12 P-ESDM sessions'],"['MBSR', 'Mindfulness Based Stress Reduction (MBSR) in conjunction with the Parent-implemented Early Start Denver Model (P-ESDM', 'P-ESDM', 'With and Without Parental Mindfulness Based Stress Reduction']","['autism severity, cognitive, and adaptive skills']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",63.0,0.0630327,There was not a significant time × group interaction for children whose parents received MBSR.,"[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Weitlauf', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA. amy.s.weitlauf@vumc.org.'}, {'ForeName': 'Neill', 'Initials': 'N', 'LastName': 'Broderick', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Alacia Stainbrook', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Slaughter', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, USA.'}, {'ForeName': 'Julie Lounds', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Catherine G', 'Initials': 'CG', 'LastName': 'Herrington', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Amy G', 'Initials': 'AG', 'LastName': 'Nicholson', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Santulli', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Dorris', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'LaTamara Jackson', 'Initials': 'LJ', 'LastName': 'Garrett', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hopton', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kinsman', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Morton', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Vogel', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Elisabeth M', 'Initials': 'EM', 'LastName': 'Dykens', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pablo Juárez', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Zachary E', 'Initials': 'ZE', 'LastName': 'Warren', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-021-05399-6']
1708,34941423,A phase 2a clinical trial of molnupiravir in patients with COVID-19 shows accelerated SARS-CoV-2 RNA clearance and elimination of infectious virus.,"There is an urgent need for an effective, oral, direct-acting therapeutic to block transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and prevent progression to severe coronavirus disease 2019 (COVID-19). In a phase 2a double-blind, placebo-controlled, randomized, multicenter clinical trial, we evaluated the safety, tolerability, and antiviral efficacy of the nucleoside analog molnupiravir in 202 unvaccinated participants with confirmed SARS-CoV-2 infection and symptom duration <7 days. Participants were randomized 1:1 to receive molnupiravir (200 mg) or placebo and then 3:1 to receive molnupiravir (400 or 800 mg) or placebo, orally twice daily for 5 days. Antiviral activity was assessed by reverse transcriptase polymerase chain reaction (RT-PCR) for SARS-CoV-2 RNA in nasopharyngeal swabs. Infectious virus was assessed by inoculation of cultured Vero cells with samples from nasopharyngeal swabs and was detected by RT-PCR. Time to viral RNA clearance (primary endpoint) was decreased in the 800-mg molnupiravir group (median 14 days) compared to the placebo group (median 15 days) (log rank  P  value = 0.013). Of participants receiving 800 mg of molnupiravir, 92.5% achieved viral RNA clearance compared with 80.3% of placebo recipients by study end (4 weeks). Infectious virus (secondary endpoint) was detected in swabs from 1.9% of the 800-mg molnupiravir group compared with 16.7% of the placebo group at day 3 of treatment ( P  = 0.016). At day 5 of treatment, infectious virus was not isolated from any participants receiving 400 or 800 mg of molnupiravir compared with 11.1% of placebo recipients ( P  = 0.034 and 0.027, respectively). Molnupiravir was well tolerated across all doses.",2022,Antiviral activity was assessed by reverse transcriptase polymerase chain reaction (RT-PCR) for SARS-CoV-2 RNA in nasopharyngeal swabs.,['202 unvaccinated participants with confirmed SARS-CoV-2 infection and symptom duration <7 days'],"['placebo', 'molnupiravir (400 or 800 mg) or placebo', 'molnupiravir (200 mg) or placebo', 'nucleoside analog molnupiravir']","['safety, tolerability, and antiviral efficacy', 'SARS-CoV-2 RNA clearance and elimination of infectious virus', 'Antiviral activity', 'viral RNA clearance', 'Time to viral RNA clearance']","[{'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside analog'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035736', 'cui_str': 'Viral RNA'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",202.0,0.290131,Antiviral activity was assessed by reverse transcriptase polymerase chain reaction (RT-PCR) for SARS-CoV-2 RNA in nasopharyngeal swabs.,"[{'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Fischer', 'Affiliation': 'Institute for Global Health and Infectious Diseases, Division of Pulmonary Diseases and Critical Care Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Eron', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Holman', 'Affiliation': 'Ridgeback Biotherapeutics LP, Miami, FL, USA.'}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'Pharstat Inc., Raleigh, NC, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Szewczyk', 'Affiliation': 'Ridgeback Biotherapeutics LP, Miami, FL, USA.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Sheahan', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Baric', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Katie R', 'Initials': 'KR', 'LastName': 'Mollan', 'Affiliation': 'Gillings School of Global Public Health, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Cameron R', 'Initials': 'CR', 'LastName': 'Wolfe', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Duke', 'Affiliation': 'Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Masoud M', 'Initials': 'MM', 'LastName': 'Azizad', 'Affiliation': 'Valley Clinical Trials Inc., Northridge, CA, USA.'}, {'ForeName': 'Katyna', 'Initials': 'K', 'LastName': 'Borroto-Esoda', 'Affiliation': 'KBE Consulting, Raleigh, NC, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wohl', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Coombs', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'James Loftis', 'Affiliation': 'Institute for Global Health and Infectious Diseases, Division of Pulmonary Diseases and Critical Care Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Alabanza', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Lipansky', 'Affiliation': 'Ridgeback Biotherapeutics LP, Miami, FL, USA.'}, {'ForeName': 'Wendy P', 'Initials': 'WP', 'LastName': 'Painter', 'Affiliation': 'Ridgeback Biotherapeutics LP, Miami, FL, USA.'}]",Science translational medicine,['10.1126/scitranslmed.abl7430']
1709,35073805,Cognition and affect in imagined and recalled scenarios as a function of a specificity manipulation: An experience sampling study.,"Previous work has examined the effect of specificity and temporal focus (i.e., memory vs. imagination) on people's cognition and associated affect. Here, using experience sampling methods, we take these previously addressed questions out of the laboratory into daily-life settings. Participants ( N  = 228) were randomly assigned to a specificity or control condition, and recorded imagined or recalled scenarios twice a day for 1 week. Results revealed a main effect of specificity where specificity prompts resulted in written scenarios that were rated by independent judges as more creative, more positive, less negative, more coherent, and incorporated more sensory content. Specificity had few direct influences on affect, though an interaction showed that imagined scenarios with specificity prompts resulted in reduced self-reported anxiety. Implications and future directions are discussed.",2022,"Results revealed a main effect of specificity where specificity prompts resulted in written scenarios that were rated by independent judges as more cre-ative, more positive, less negative, more coherent, and incorporated more sensory content.",['Participants (N = 228'],"['specificity or control condition, and recorded imagined or recalled scenarios twice a day for one week']",[],[],"[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1442452', 'cui_str': 'One week'}]",[],228.0,0.0464074,"Results revealed a main effect of specificity where specificity prompts resulted in written scenarios that were rated by independent judges as more cre-ative, more positive, less negative, more coherent, and incorporated more sensory content.","[{'ForeName': 'Darya L', 'Initials': 'DL', 'LastName': 'Zabelina', 'Affiliation': 'Department of Psychological Science, University of Arkansas, Fayetteville, AR, USA.'}, {'ForeName': 'Peyton E', 'Initials': 'PE', 'LastName': 'Jennings', 'Affiliation': 'Department of Psychological Science, University of Arkansas, Fayetteville, AR, USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Veilleux', 'Affiliation': 'Department of Psychological Science, University of Arkansas, Fayetteville, AR, USA.'}]",Quarterly journal of experimental psychology (2006),['10.1177/17470218221078869']
1710,35076697,Continuous Glucose Monitoring in Adults With Type 1 Diabetes With 35 Years Duration From the DCCT/EDIC Study.,"OBJECTIVE


We evaluated blinded continuous glucose monitoring (CGM) profiles in a subset of adults with type 1 diabetes from the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study to characterize the frequency of glycemic excursions and contributing factors.
RESEARCH DESIGN AND METHODS


CGM-derived metrics were compared for daytime and nighttime periods using blinded CGM for a minimum of 6.5 days (average 11.9 days) and correlated with HbA1c levels, routine use of diabetes devices, and other characteristics in 765 participants.
RESULTS


Participants were 58.9 ± 6.5 years of age with diabetes duration 36.8 ± 4.9 years and HbA1c 7.8 ± 1.2%; 58% used insulin pumps, and 27% used personal, unblinded CGM. Compared with daytime, nighttime mean sensor glucose was lower, percent time in range 70-180 mg/dL (TIR) was similar, and hypoglycemia was more common. Over the entire recording period, only 9% of the 765 participants achieved >70% TIR and only 28% achieved <1% of observations of <54 mg/dL. Indeed, participants with the highest percentage of hypoglycemia had the lowest HbA1c levels. However, use of insulin pumps and CGM decreased the percent time at <54 mg/dL.
CONCLUSIONS


In adults with long-standing type 1 diabetes, short-term blinded CGM profiles revealed frequent clinically significant hypoglycemia (<54 mg/dL) during the night and more time in hyperglycemia during the day. The small subset of participants using routine CGM and insulin pumps had fewer hypoglycemic and hyperglycemic excursions and lower HbA1c levels. Thus, strategies to lower meal-stimulated hyperglycemia during the day and prevent hypoglycemia at night are relevant clinical goals in older patients with type 1 diabetes.",2022,"Compared with daytime, nighttime mean sensor glucose was lower, percent time in range 70-180 mg/dL (TIR) was similar, and hypoglycemia was more common.","['Participants were 58.9 ± 6.5 years of age with diabetes duration 36.8 ± 4.9 years and HbA1c 7.8 ± 1.2%; 58% used insulin pumps, and 27% used personal, unblinded CGM', 'Adults With Type 1 Diabetes With 35 Years Duration', 'older patients with type 1 diabetes', '765 participants', 'adults with type 1 diabetes from the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC']","['insulin pumps and CGM', 'continuous glucose monitoring (CGM) profiles']","['hypoglycemia', 'hypoglycemic and hyperglycemic excursions and lower HbA1c levels', 'time in hyperglycemia', 'daytime, nighttime mean sensor glucose']","[{'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",765.0,0.0769436,"Compared with daytime, nighttime mean sensor glucose was lower, percent time in range 70-180 mg/dL (TIR) was similar, and hypoglycemia was more common.","[{'ForeName': 'Rose A', 'Initials': 'RA', 'LastName': 'Gubitosi-Klug', 'Affiliation': ""Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, OH.""}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'Braffett', 'Affiliation': 'Biostatistics Center, George Washington University, Rockville, MD.'}, {'ForeName': 'Ionut', 'Initials': 'I', 'LastName': 'Bebu', 'Affiliation': 'Biostatistics Center, George Washington University, Rockville, MD.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'International Diabetes Center, Minneapolis, MN.'}, {'ForeName': 'Kaleigh', 'Initials': 'K', 'LastName': 'Farrell', 'Affiliation': ""Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, OH.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kenny', 'Affiliation': 'Biostatistics Center, George Washington University, Rockville, MD.'}, {'ForeName': 'Victoria R', 'Initials': 'VR', 'LastName': 'Trapani', 'Affiliation': 'Biostatistics Center, George Washington University, Rockville, MD.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Meadema-Mayer', 'Affiliation': ""Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, OH.""}, {'ForeName': 'Elsayed Z', 'Initials': 'EZ', 'LastName': 'Soliman', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Lachin', 'Affiliation': 'Biostatistics Center, George Washington University, Rockville, MD.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'International Diabetes Center, Minneapolis, MN.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Tamborlane', 'Affiliation': 'Yale University, New Haven, CT.'}]",Diabetes care,['10.2337/dc21-0629']
1711,35080495,A Novel Body Weight-Supported Postural Perturbation Module for Gait and Balance Rehabilitation After Stroke: Preliminary Evaluation Study.,"BACKGROUND


Impaired balance regulation after stroke puts patients and therapists at risk of injury during rehabilitation. Body weight support systems (BWSSs) minimize this risk and allow patients to safely practice balance activities during therapy. Treadmill-based balance perturbation systems with BWSSs are known to improve balance in patients with age- or disease-related impairments. However, these stationary systems are unable to accommodate complex exercises that require more freedom of movement.
OBJECTIVE


This study aims to evaluate the effect of a new balance perturbation module, which is directly integrated into a track-mounted BWSS, on balance impairments secondary to acute stroke.
METHODS


This unblinded quasi-randomized controlled preliminary study was conducted in a rehabilitation-focused long-term acute care hospital. Participants were recruited from stroke rehabilitation inpatients with an admission Berg Balance Scale (BBS) score of 21 (out of 56) or greater. Over a 2-week period, consented participants completed 8 BWSS or BWSS with perturbation (BWSS-P) treatment sessions; study activities were incorporated into regular treatment to avoid disruption of their normal care. Although both groups conducted the same balance and gait activities during their treatment sessions, the BWSS-P sessions included lateral, anterior, and posterior balance perturbations. Pre- and postintervention BBS and Activities-Specific Balance Confidence (ABC) assessments were the primary outcome measures collected. Institutional BBS data from the year before installation of the track-mounted BWSS were retrospectively included as a post hoc historical standard of care comparison.
RESULTS


The improved postintervention BBS and ABC assessment scores showed that all participants benefited from therapy (P<.001 for all pre- and postintervention comparisons). The average BBS percent change for the BWSS-P sample (n=14) was 66.95% (SD 43.78%) and that for the BWSS control sample (n=15) was 53.29% (SD 24.13%). These values were greater than those for the standard of care group (n=30; mean 28.31%, SD 17.25%; P=.02 and P=.005 respectively), with no difference among the BWSS groups (P=.67). ABC score changes were also similar among the preintervention and postintervention BWSS groups (P=.94 and P=.92, respectively).
CONCLUSIONS


Both BWSS groups demonstrated similar BBS and ABC score improvements, indicating that balance perturbations were not detrimental to postacute stroke rehabilitation and were safe to use. These data provide strong rationale and baseline data for conducting a larger follow-up study to further assess if this new perturbation system provides additional benefit to the rehabilitation of gait and balance impairments following stroke.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04919161; https://clinicaltrials.gov/ct2/show/NCT04919161.",2022,Improved post-intervention BBS and ABC assessment scores showed all participants benefited from therapy (P < .001 for all pre/post comparisons).,"['Gait and Balance Rehabilitation after Stroke', 'Participants were recruited from stroke rehabilitation inpatients with an admission Berg Balance Scale (BBS) score of 21/56 or greater', 'patients with age or disease related impairments', 'stroke put patients and therapists at risk for injury during rehabilitation']","['Body-weight-support systems (BWSSs', 'Pre- and post-intervention BBS and Activities', 'Novel Body-Weight Supported Postural Perturbation Module']","['BWSS control', 'BBS and ABC score improvements', 'ABC score-changes', 'Specific Balance-Confidence (ABC) assessments', 'ABC assessment scores']","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0582456', 'cui_str': 'At risk for injury'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0748877', 'cui_str': 'Social Support System'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",15.0,0.037614,Improved post-intervention BBS and ABC assessment scores showed all participants benefited from therapy (P < .001 for all pre/post comparisons).,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'Department of Inpatient Occupational Therapy, Gaylord Specialty Healthcare, Wallingford, CT, United States.'}, {'ForeName': 'Henry Charles', 'Initials': 'HC', 'LastName': 'Hrdlicka', 'Affiliation': 'Milne Institute for Healthcare Innovation, Gaylord Specialty Healthcare, Wallingford, CT, United States.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Cutler', 'Affiliation': 'Department of Inpatient Physical Therapy, Gaylord Specialty Healthcare, Wallingford, CT, United States.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Hellstrand', 'Affiliation': 'Department of Inpatient Physical Therapy, Gaylord Specialty Healthcare, Wallingford, CT, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Meise', 'Affiliation': 'Department of Inpatient Occupational Therapy, Gaylord Specialty Healthcare, Wallingford, CT, United States.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Rudolf', 'Affiliation': 'Department of Inpatient Physical Therapy, Gaylord Specialty Healthcare, Wallingford, CT, United States.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Grevelding', 'Affiliation': 'Milne Institute for Healthcare Innovation, Gaylord Specialty Healthcare, Wallingford, CT, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Nankin', 'Affiliation': 'Frank H Netter MD School of Medicine, Quinnipiac University, North Haven, CT, United States.'}]",JMIR rehabilitation and assistive technologies,['10.2196/31504']
1712,34984729,Parkinson Disease and Subthalamic Nucleus Deep Brain Stimulation: Cognitive Effects in GBA Mutation Carriers.,"OBJECTIVE


This study was undertaken to compare the rate of change in cognition between glucocerebrosidase (GBA) mutation carriers and noncarriers with and without subthalamic nucleus deep brain stimulation (STN-DBS) in Parkinson disease.
METHODS


Clinical and genetic data from 12 datasets were examined. Global cognition was assessed using the Mattis Dementia Rating Scale (MDRS). Subjects were examined for mutations in GBA and categorized as GBA carriers with or without DBS (GBA+DBS+, GBA+DBS-), and noncarriers with or without DBS (GBA-DBS+, GBA-DBS-). GBA mutation carriers were subcategorized according to mutation severity (risk variant, mild, severe). Linear mixed modeling was used to compare rate of change in MDRS scores over time among the groups according to GBA and DBS status and then according to GBA severity and DBS status.
RESULTS


Data were available for 366 subjects (58 GBA+DBS+, 82 GBA+DBS-, 98 GBA-DBS+, and 128 GBA-DBS- subjects), who were longitudinally followed (range = 36-60 months after surgery). Using the MDRS, GBA+DBS+ subjects declined on average 2.02 points/yr more than GBA-DBS- subjects (95% confidence interval [CI] = -2.35 to -1.69), 1.71 points/yr more than GBA+DBS- subjects (95% CI = -2.14 to -1.28), and 1.49 points/yr more than GBA-DBS+ subjects (95% CI = -1.80 to -1.18).
INTERPRETATION


Although not randomized, this composite analysis suggests that the combined effects of GBA mutations and STN-DBS negatively impact cognition. We advise that DBS candidates be screened for GBA mutations as part of the presurgical decision-making process. We advise that GBA mutation carriers be counseled regarding potential risks associated with STN-DBS so that alternative options may be considered. ANN NEUROL 2022;91:424-435.",2022,"Using the MDRS, GBA+DBS+ subjects declined on average 2.02 points/yr more than GBA-DBS- subjects (95% confidence interval [CI] = -2.35 to -1.69), 1.71 points/yr more than GBA+DBS- subjects (95% CI = -2.14 to -1.28), and 1.49 points/yr more than GBA-DBS+ subjects (95% CI = -1.80 to -1.18).
","['GBA Mutation Carriers', 'Parkinson disease', '366 subjects (58 GBA+DBS+, 82 GBA+DBS-, 98 GBA-DBS+, and 128 GBA-DBS- subjects), who were longitudinally followed (range\xa0=\xa036-60\xa0months after surgery']","['glucocerebrosidase (GBA) mutation carriers and noncarriers with and without subthalamic nucleus deep brain stimulation (STN-DBS', 'Deep Brain Stimulation']","['Mattis Dementia Rating Scale (MDRS', 'rate of change in MDRS scores', 'Global cognition', 'Parkinson Disease and Subthalamic Nucleus']","[{'cui': 'C0017768', 'cui_str': 'Beta-glucocerebrosidase'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0017768', 'cui_str': 'Beta-glucocerebrosidase'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}]",,0.106363,"Using the MDRS, GBA+DBS+ subjects declined on average 2.02 points/yr more than GBA-DBS- subjects (95% confidence interval [CI] = -2.35 to -1.69), 1.71 points/yr more than GBA+DBS- subjects (95% CI = -2.14 to -1.28), and 1.49 points/yr more than GBA-DBS+ subjects (95% CI = -1.80 to -1.18).
","[{'ForeName': 'Gian', 'Initials': 'G', 'LastName': 'Pal', 'Affiliation': 'Department of Neurology, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Mangone', 'Affiliation': 'Sorbonne University, Public Hospital Network of Paris, Inserm, National Center for Scientific Research, Paris Brain Institute, Pitié-Salpêtrière Hospital, Department of Neurology, Center for Clinical Investigation Neurosciences, Paris, France.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Hill', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Bichun', 'Initials': 'B', 'LastName': 'Ouyang', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Yuanqing', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Lythe', 'Affiliation': 'Department of Clinical and Movement Neurosciences, University College London Institute of Neurology, London, UK.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Ehrlich', 'Affiliation': ""Parkinson's Disease Clinic, Office of the Clinical Director, National Institutes of Health/National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Saunders-Pullman', 'Affiliation': 'Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Shanker', 'Affiliation': 'Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bressman', 'Affiliation': 'Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Roy N', 'Initials': 'RN', 'LastName': 'Alcalay', 'Affiliation': 'Department of Neurology, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Garcia', 'Affiliation': 'Department of Neurology, New York Medical College, Valhalla, NY, USA.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'Marder', 'Affiliation': 'Department of Neurology, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Aasly', 'Affiliation': 'Department of Neurology, St Olavs Hospital and Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'M Maral', 'Initials': 'MM', 'LastName': 'Mouradian', 'Affiliation': 'Department of Neurology, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Link', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Rosenbaum', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Sharlet', 'Initials': 'S', 'LastName': 'Anderson', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Bernard', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Stebbins', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Nichols', 'Affiliation': ""Division of Human Genetics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Welter', 'Affiliation': 'Sorbonne University, Public Hospital Network of Paris, Inserm, National Center for Scientific Research, Paris Brain Institute, Pitié-Salpêtrière Hospital, Department of Neurology, Center for Clinical Investigation Neurosciences, Paris, France.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Sani', 'Affiliation': 'Department of Neurosurgery, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Afshari', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Verhagen', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Rob M A', 'Initials': 'RMA', 'LastName': 'de Bie', 'Affiliation': 'Amsterdam University Medical Centers, University of Amsterdam, Department of Neurology, Amsterdam Neuroscience, Amsterdam, The Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Department of Clinical and Movement Neurosciences, University College London Institute of Neurology, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Hall', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Corvol', 'Affiliation': 'Sorbonne University, Public Hospital Network of Paris, Inserm, National Center for Scientific Research, Paris Brain Institute, Pitié-Salpêtrière Hospital, Department of Neurology, Center for Clinical Investigation Neurosciences, Paris, France.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Goetz', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}]",Annals of neurology,['10.1002/ana.26302']
1713,35028899,Rapid Treatment with Intramuscular Magnesium Sulfate During Cardiopulmonary Resuscitation Does Not Provide Neuroprotection Following Cardiac Arrest.,"Brain injury is the most common cause of death for patients resuscitated from cardiac arrest. Magnesium is an attractive neuroprotective compound which protects neurons from ischemic injury by reducing neuronal calcium overload via NMDA receptor modulation and preventing calcium-induced mitochondrial permeability transition. Intramuscular (IM) delivery of MgSO 4  during CPR has the potential to target these mechanisms within an early therapeutic window. We hypothesize that IM MgSO 4  administrated during CPR could achieve therapeutic serum magnesium levels within 15 min after ROSC and improve neurologic outcomes in a rat model of asphyxial cardiac arrest. Male Long Evans rats were subjected to 8-min asphyxial cardiac arrest and block randomized to receive placebo, 107 mg/kg, 215 mg/kg, or 430 mg/kg MgSO 4  IM at the onset of CPR. Serum magnesium concentrations increased rapidly with IM delivery during CPR, achieving twofold to fourfold increase by 15 min after ROSC in all magnesium dose groups. Rats subjected to cardiac arrest or sham surgery were block randomized to treatment groups for assessment of neurological outcomes. We found that IM MgSO 4  during CPR had no effect on ROSC rate (p > 0.05). IM MgSO 4  treatment had no statistically significant effect on 10-day survival with good neurologic function or hippocampal CA1 pyramidal neuron survival compared to placebo treatment. In conclusion, a single dose IM MgSO 4  during CPR achieves up to fourfold baseline serum magnesium levels within 15 min after ROSC; however, this treatment strategy did not improve survival, recovery of neurologic function, or neuron survival. Future studies with repeated dosing or in combination with hypothermic targeted temperature management may be indicated.",2022,IM MgSO 4  treatment had no statistically significant effect on 10-day survival with good neurologic function or hippocampal CA1 pyramidal neuron survival compared to placebo treatment.,"['patients resuscitated from cardiac arrest', 'Male Long Evans rats']","['placebo', 'cardiac arrest or sham surgery', 'Intramuscular Magnesium Sulfate', 'Magnesium']","['survival, recovery of neurologic function, or neuron survival', 'Serum magnesium concentrations', 'ROSC rate', 'neurologic outcomes', 'baseline serum magnesium levels', '10-day survival with good neurologic function or hippocampal CA1 pyramidal neuron survival', 'therapeutic serum magnesium levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0027882', 'cui_str': 'Neuron'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0694598', 'cui_str': 'CA1 Field of Hippocampus'}, {'cui': 'C0206441', 'cui_str': 'Pyramidal cell'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",,0.242192,IM MgSO 4  treatment had no statistically significant effect on 10-day survival with good neurologic function or hippocampal CA1 pyramidal neuron survival compared to placebo treatment.,"[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Bryson', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Garrett M', 'Initials': 'GM', 'LastName': 'Fogo', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Jinhui', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Raghunayakula', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mathieu', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Wider', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Maheras', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Katlynn J', 'Initials': 'KJ', 'LastName': 'Emaus', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Gruley', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Yuguo', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency Medicine, Qilu Hospital of Shandong University, Jinan, 250012, China.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Neumar', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA. neumar@umich.edu.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Sanderson', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA. thsand@umich.edu.'}]",Molecular neurobiology,['10.1007/s12035-021-02645-x']
1714,35078958,An Experimental Study to Assess the Professional and Social Consequences of Tardive Dyskinesia.,"Objective


Antipsychotic medications may cause tardive dyskinesia (TD), an often-irreversible movement disorder characterized by involuntary movements that are typically stereotypic, choreiform, or dystonic and may impair quality of life. This study evaluated others' perceptions of abnormal TD movements in professional and social situations.
Methods


This was an experimental, randomized, blinded, digital survey in a general population sample. Participants were randomized 1:1 into a test or control group to view a video of a professional actor simulating TD movements or no TD movements prior to completing surveys on employment, dating, and friendship domains. Assessments for mild-to-moderate and moderate-to-severe TD movements were conducted separately. Authenticity of abnormal movements and Abnormal Involuntary Movement Scale (AIMS) scores were evaluated by physician experts.
Results


Surveys were completed by 2,400 participants each for mild-to-moderate and moderate-to-severe TD. In all domains, participants responded significantly less favorably to persons with TD movements (both mild-to-moderate and moderate-to-severe) than those without TD movements. Fewer participants in the test versus control group for mild-to-moderate and moderate-to-severe TD, respectively, considered the candidate as a potential employee (29.2% and 22.7% fewer), found him/her attractive (20.5% and 18.7% fewer), and were interested in becoming friends with him/her (12.3% and 16.5% fewer).
Conclusion


Professional actors simulating TD movements were perceived more negatively than those without TD movements in employment, dating, and friendship domains. To our knowledge, this is the first randomized study to quantify professional and social stigma associated with TD movements that may reduce opportunities for gainful employment, marital status, and an effective support system.",2022,"Conclusion


Professional actors simulating TD movements were perceived more negatively than those without TD movements in employment, dating, and friendship domains.",['Tardive Dyskinesia'],"['Antipsychotic medications', 'control group to view a video of a professional actor simulating TD movements or no TD movements prior to completing surveys on employment, dating, and friendship domains']","['mild-to-moderate and moderate-to-severe TD', 'Authenticity of abnormal movements and Abnormal Involuntary Movement Scale (AIMS) scores']","[{'cui': 'C0686347', 'cui_str': 'Tardive dyskinesia'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0686347', 'cui_str': 'Tardive dyskinesia'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0686347', 'cui_str': 'Tardive dyskinesia'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0450978', 'cui_str': 'Abnormal involuntary movement scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0446189,"Conclusion


Professional actors simulating TD movements were perceived more negatively than those without TD movements in employment, dating, and friendship domains.","[{'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Ayyagari', 'Affiliation': 'Analysis Group, Inc., Boston, MA, USA.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Goldschmidt', 'Affiliation': 'Analysis Group, Inc., Boston, MA, USA.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Mu', 'Affiliation': 'Analysis Group, Inc., Boston, MA, USA.'}, {'ForeName': 'Stanley N', 'Initials': 'SN', 'LastName': 'Caroff', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Carroll', 'Affiliation': 'Teva Pharmaceuticals, West Chester, PA, USA.'}]",Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology,['10.9758/cpn.2022.20.1.154']
1715,35078957,"Comparison between Atomoxetine and OROS Methylphenidate as an Adjunctive to SSRIs in Attention-deficit/Hyperactivity Disorder Adults with Comorbid Partially Responsive Major Depressive Disorder: A Head-to-head, 12-week, Randomized, Rater-blinded Clinical Trial.","Objective


This study aimed to compare the efficacy and safety of atomoxetine (ATX) and OROS methylphenidate (MPH) as adjunctive to selective serotonin reuptake inhibitors (SSRIs) in adults with attention-deficit hyperactivity disorder (ADHD) with comorbid partially responsive major depressive disorder (MDD).
Methods


Sixty Korean adults with ADHD and comorbid partially responsive MDD were recruited in a 12-week, randomized, rater-blinded, active-controlled trial and were evenly randomized to ATX or OROS MPH treatment.
Results


Depressive symptoms measured using the Hamilton Depression Rating Scale and Clinically Useful Depression Outcome Scale, and ADHD symptoms measured using the Adult ADHD Self-Report Scale, as well as the Clinical Global Impression-Severity, Clinical Global Impression-Improvement, and the Sheehan Disability Scale scores were significantly improved in both groups during the 12 weeks of treatment. The changes in all outcome measures during the 12-week treatment were not significantly different between the two groups (all  p  > 0.05). No serious adverse events were reported and there were no significant differences in systolic and diastolic blood pressure, pulse rate, weight, or body mass index between the ATX and MPH groups.
Conclusion


Our findings suggest that ATX and MPH can be used as adjunctive treatments in adults with ADHD and comorbid partially responsive MDD. The efficacy and tolerability of ATX and MPH in adults with ADHD did not differ significantly. Further studies should be conducted to draw a definitive conclusion.",2022,"No serious adverse events were reported and there were no significant differences in systolic and diastolic blood pressure, pulse rate, weight, or body mass index between the ATX and MPH groups.
","['Attention-deficit/Hyperactivity Disorder Adults with Comorbid Partially Responsive Major Depressive Disorder', 'adults with attention-deficit hyperactivity disorder (ADHD) with comorbid partially responsive major depressive disorder (MDD', 'adults with ADHD', 'Sixty Korean adults with ADHD and comorbid partially responsive MDD', 'adults with ADHD and comorbid partially responsive MDD']","['ATX', 'serotonin reuptake inhibitors (SSRIs', 'ATX and MPH', 'ATX or OROS MPH treatment', 'Atomoxetine and OROS Methylphenidate', 'atomoxetine (ATX) and OROS methylphenidate (MPH']","['efficacy and safety', 'efficacy and tolerability', 'Depressive symptoms', 'systolic and diastolic blood pressure, pulse rate, weight, or body mass index', 'Hamilton Depression Rating Scale and Clinically Useful Depression Outcome Scale, and ADHD symptoms measured using the Adult ADHD Self-Report Scale', 'serious adverse events', 'Clinical Global Impression-Severity, Clinical Global Impression-Improvement, and the Sheehan Disability Scale scores']","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C0162758', 'cui_str': 'Serotonin uptake inhibitor'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0865424', 'cui_str': 'Adult attention deficit hyperactivity disorder'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0871455,"No serious adverse events were reported and there were no significant differences in systolic and diastolic blood pressure, pulse rate, weight, or body mass index between the ATX and MPH groups.
","[{'ForeName': 'Se-Hoon', 'Initials': 'SH', 'LastName': 'Shim', 'Affiliation': 'Department of Psychiatry, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Young Sup', 'Initials': 'YS', 'LastName': 'Woo', 'Affiliation': 'Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'In Soo', 'Initials': 'IS', 'LastName': 'Heo', 'Affiliation': 'Department of Psychiatry, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Hee-Jung', 'Initials': 'HJ', 'LastName': 'Yoon', 'Affiliation': 'Korean Society of Infectious Diseases, Seoul, Korea.'}, {'ForeName': 'Hyung Mo', 'Initials': 'HM', 'LastName': 'Sung', 'Affiliation': 'Department of Psychiatry, Soonchunhyang University Gumi Hospital, Soonchunhyang University College of Medicine, Gumi, Korea.'}, {'ForeName': 'Jonghun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Daegu Catholic University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Won-Myong', 'Initials': 'WM', 'LastName': 'Bahk', 'Affiliation': 'Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}]",Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology,['10.9758/cpn.2022.20.1.143']
1716,35078951,"Effect of Self-administered Transcranial Direct Stimulation in Patients with Major Depressive Disorder: A Randomized, Single-blinded Clinical Trial.","Objective


In numerous studies that have addressed transcranial direct current stimulation (tDCS) devices, participants visit the hospital regularly and undergo stimulation directed by health professionals. This method has the advantage of being able to deliver accurate stimuli in a controlled environment, but it does not adopt the merits of tDCS portability and applicability. Thus, it may be necessary to investigate how self-administered tDCS treatment at home affects depression- related symptoms.
Methods


In this randomized, single-blinded clinical trial, 58 patients with major depressive disorder were assigned to active and sham tDCS stimulation groups, and treatment responses were evaluated biweekly over six weeks. Both active and sham tDCS treatment group were treated with escitalopram. All participants were instructed the protocol and usage of at-home tDCS device, and self-administered tDCS treatment at their home.
Results


The beck-depression inventory score decreased significantly as treatment progressed, and the degree of symptom improvement was significantly higher in the active group than in the sham tDCS group. There were no significant differences between the two groups in other indices, including the Hamilton Depression Scale.
Conclusion


These results suggest that patient-administered tDCS treatment might be effective in improving subjective symptoms of depression.",2022,"There were no significant differences between the two groups in other indices, including the Hamilton Depression Scale.
","['58 patients with major depressive disorder', 'Patients with Major Depressive Disorder']","['transcranial direct current stimulation (tDCS) devices', 'active and sham tDCS stimulation', 'Self-administered Transcranial Direct Stimulation', 'escitalopram', 'tDCS']","['subjective symptoms of depression', 'beck-depression inventory score', 'degree of symptom improvement', 'Hamilton Depression Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",58.0,0.104162,"There were no significant differences between the two groups in other indices, including the Hamilton Depression Scale.
","[{'ForeName': 'Jihoon', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': ""Department of Psychiatry, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Kuk-In', 'Initials': 'KI', 'LastName': 'Jang', 'Affiliation': ""Department of Psychiatry, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Sekye', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': ""Department of Psychiatry, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Jeong-Ho', 'Initials': 'JH', 'LastName': 'Chae', 'Affiliation': ""Department of Psychiatry, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}]",Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology,['10.9758/cpn.2022.20.1.87']
1717,35080094,Longitudinal effects of physical exercise on health-related outcomes based on frailty status in community-dwelling older adults.,"AIM


To clarify the difference in the longitudinal effects of physical exercise on health-related outcomes according to the baseline frailty status (frail or non-frail) in community-dwelling older adults.
METHODS


Participants included 177 adults aged ≥65 years who carried out multicomponent physical exercises (strength, aerobic, gait and balance) for 40 min, one to three times per week, for 1 year at a day-care center. Bodyweight, comfortable walking speed, 6-min walking distance and Mini-Mental State Examination were measured at baseline and every 3 months. For longitudinal trend, we analyzed the change in scores from baseline for each outcome using the linear mixed effects model. Fixed effects included ""group"" (frail or non-frail), ""time"" (4 time points every 3 months, from 3 to 12 months) and ""interaction between group and time.""
RESULTS


The effect sizes from baseline showed almost all positive values for each outcome. The linear mixed effects model showed significant effects on ""interaction between group and time"" in changes in bodyweight (P = 0.033), ""group"" in changes in walking speed (P = 0.013) and ""time"" in changes in the Mini-Mental State Examination (P < 0.001). Bodyweight showed a decreasing trend in the non-frail group after 3 months, unlike in the frail group. For walking speed, moderate effect sizes (d = 0.67-0.74) were sustained over time in the frail group, as did lesser effect sizes (d = 0.26-0.40) in the non-frail group.
CONCLUSIONS


Exercise-based multicomponent interventions were effective for both groups. The longitudinal effects on walking speed and bodyweight were greater in the frail group. Geriatr Gerontol Int 2022; 22: 213-218.",2022,"For walking speed, moderate effect sizes (d = 0.67-0.74) were sustained over time in the frail group, as did lesser effect sizes (d = 0.26-0.40) in the non-frail group.
","['community-dwelling older adults', 'Participants included 177 adults aged ≥65\u2009years who carried out']","['group"" (frail or non-frail), ""time', 'physical exercise', 'Exercise-based multicomponent interventions', 'multicomponent physical exercises (strength, aerobic, gait and balance']","['interaction', 'time', 'Bodyweight, comfortable walking speed, 6-min walking distance and Mini-Mental State Examination', 'walking speed and bodyweight', 'walking speed']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}]",177.0,0.0415663,"For walking speed, moderate effect sizes (d = 0.67-0.74) were sustained over time in the frail group, as did lesser effect sizes (d = 0.26-0.40) in the non-frail group.
","[{'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Wakida', 'Affiliation': 'Faculty of Rehabilitation, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Asai', 'Affiliation': 'Faculty of Rehabilitation, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Kubota', 'Affiliation': 'KMU Day-Care Center Kori, Kansai Medical University Kori Hospital, Osaka, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Rehabilitation, Kansai Medical University Hospital, Osaka, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Fukumoto', 'Affiliation': 'Faculty of Rehabilitation, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'Faculty of Rehabilitation, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Nakano', 'Affiliation': 'Faculty of Rehabilitation, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Kimihiko', 'Initials': 'K', 'LastName': 'Mori', 'Affiliation': 'Faculty of Rehabilitation, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Tome', 'Initials': 'T', 'LastName': 'Ikezoe', 'Affiliation': 'Faculty of Rehabilitation, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Kimitaka', 'Initials': 'K', 'LastName': 'Hase', 'Affiliation': 'Department of Rehabilitation, Kansai Medical University Hospital, Osaka, Japan.'}]",Geriatrics & gerontology international,['10.1111/ggi.14346']
1718,34873781,Critical role of rhythms in prefrontal transcranial magnetic stimulation for depression: A randomized sham-controlled study.,"Repetitive transcranial magnetic stimulation (rTMS) is an alternative treatment for depression, but the neural correlates of the treatment are currently inconclusive, which might be a limit of conventional analytical methods. The present study aimed to investigate the neurophysiological evidence and potential biomarkers for rTMS and intermittent theta burst stimulation (iTBS) treatment. A total of 61 treatment-resistant depression patients were randomly assigned to receive prolonged iTBS (piTBS; N = 19), 10 Hz rTMS (N = 20), or sham stimulation (N = 22). Each participant went through a treatment phase with resting state electroencephalography (EEG) recordings before and after the treatment phase. The aftereffects of stimulation showed that theta-alpha amplitude modulation frequency (f am  ) was associated with piTBS_Responder, which involves repetitive bursts delivered in the theta frequency range, whereas alpha carrier frequency (f c  ) was related to 10 Hz rTMS, which uses alpha rhythmic stimulation. In addition, theta-alpha amplitude modulation frequency was positively correlated with piTBS antidepressant efficacy, whereas the alpha frequency was not associated with the 10 Hz rTMS clinical outcome. The present study showed that TMS stimulation effects might be lasting, with changes of brain oscillations associated with the delivered frequency. Additionally, theta-alpha amplitude modulation frequency may be as a function of the degree of recovery in TRD with piTBS treatment and also a potential EEG-based predictor of antidepressant efficacy of piTBS in the early treatment stage, that is, first 2 weeks.",2022,"The aftereffects of stimulation showed that theta-alpha amplitude modulation frequency (f am  ) was associated with piTBS_Responder, which involves repetitive bursts delivered in the theta frequency range, whereas alpha carrier frequency (f c  ) was related to 10 Hz rTMS, which uses alpha rhythmic stimulation.","['A total of 61 treatment-resistant depression patients', 'depression']","['TMS', 'rTMS and intermittent theta burst stimulation (iTBS) treatment', 'Repetitive transcranial magnetic stimulation (rTMS', 'prefrontal transcranial magnetic stimulation', 'prolonged iTBS (piTBS; N\xa0=\xa019), 10\xa0Hz rTMS (N\xa0=\xa020), or sham stimulation']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]",[],61.0,0.0262163,"The aftereffects of stimulation showed that theta-alpha amplitude modulation frequency (f am  ) was associated with piTBS_Responder, which involves repetitive bursts delivered in the theta frequency range, whereas alpha carrier frequency (f c  ) was related to 10 Hz rTMS, which uses alpha rhythmic stimulation.","[{'ForeName': 'Yi-Chun', 'Initials': 'YC', 'LastName': 'Tsai', 'Affiliation': 'Institute of Cognitive Neuroscience, College of Health Sciences and Technology, National Central University, Taoyuan City, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Institute of Cognitive Neuroscience, College of Health Sciences and Technology, National Central University, Taoyuan City, Taiwan.'}, {'ForeName': 'Wei-Kuang', 'Initials': 'WK', 'LastName': 'Liang', 'Affiliation': 'Institute of Cognitive Neuroscience, College of Health Sciences and Technology, National Central University, Taoyuan City, Taiwan.'}, {'ForeName': 'Neil G', 'Initials': 'NG', 'LastName': 'Muggleton', 'Affiliation': 'Institute of Cognitive Neuroscience, College of Health Sciences and Technology, National Central University, Taoyuan City, Taiwan.'}, {'ForeName': 'Chong-Chih', 'Initials': 'CC', 'LastName': 'Tsai', 'Affiliation': 'Institute of Cognitive Neuroscience, College of Health Sciences and Technology, National Central University, Taoyuan City, Taiwan.'}, {'ForeName': 'Norden E', 'Initials': 'NE', 'LastName': 'Huang', 'Affiliation': 'Key Laboratory of Data Analysis and Applications, First Institute of Oceanography, State Oceanic Administration, Qingdao, China.'}, {'ForeName': 'Chi-Hung', 'Initials': 'CH', 'LastName': 'Juan', 'Affiliation': 'Institute of Cognitive Neuroscience, College of Health Sciences and Technology, National Central University, Taoyuan City, Taiwan.'}]",Human brain mapping,['10.1002/hbm.25740']
1719,35086119,A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 4 to 6 Years.,"SIGNIFICANCE


Binocular treatment for unilateral amblyopia is an emerging treatment that requires evaluation through a randomized clinical trial.
PURPOSE


This study aimed to compare change in amblyopic-eye visual acuity (VA) in children aged 4 to 6 years treated with the dichoptic binocular iPad (Apple, Cupertino, CA) game, Dig Rush (not yet commercially available; Ubisoft, Montreal, Canada), plus continued spectacle correction versus continued spectacle correction alone.
METHODS


Children (mean age, 5.7 years) were randomly assigned to home treatment for 8 weeks with the iPad game (prescribed 1 h/d, 5 d/wk [n = 92], or continued spectacle correction alone [n = 90]) in a multicenter randomized clinical trial. Before enrollment, children wearing spectacles were required to have at least 16 weeks of wear or no improvement in amblyopic-eye VA (<0.1 logMAR) for at least 8 weeks. Outcome was change in amblyopic-eye VA from baseline to 4 weeks (primary) and 8 weeks (secondary) assessed by masked examiner.
RESULTS


A total of 182 children with anisometropic (63%), strabismic (16%; <5∆ near, simultaneous prism and cover test), or combined-mechanism (20%) amblyopia (20/40 to 20/200; mean, 20/63) were enrolled. After 4 weeks, mean amblyopic VA improved by 1.1 logMAR lines with binocular treatment and 0.6 logMAR lines with spectacles alone (adjusted difference, 0.5 lines; 95.1% confidence interval [CI], 0.1 to 0.9). After 8 weeks, results (binocular treatment: mean amblyopic-eye VA improvement, 1.3 vs. 1.0 logMAR lines with spectacles alone; adjusted difference, 0.3 lines; 98.4% CI, -0.2 to 0.8 lines) were inconclusive because the CI included both zero and the pre-defined difference in mean VA change of 0.75 logMAR lines.
CONCLUSIONS


In 4- to 6-year-old children with amblyopia, binocular Dig Rush treatment resulted in greater improvement in amblyopic-eye VA for 4 weeks but not 8 weeks. Future work is required to determine if modifications to the contrast increment algorithm or other aspects of the game or its implementation could enhance the treatment effect.",2022,"After 4 weeks, mean amblyopic VA improved 1.1 logMAR lines with binocular treatment and 0.6 logMAR lines with spectacles alone (adjusted difference = 0.5 lines; 95.1% CI: 0.1 to 0.9).","['Children (mean 5.7 years', '182 children with anisometropic (63%), strabismic (16%) (<5[INCREMENT] near, simultaneous prism and cover test), or combined-mechanism (20%) amblyopia (20/40 to 20/200, mean 20/63) were enrolled', 'Aged 4 to 6 Years of Age', 'Amblyopia in Children', 'children aged 4 to 6 years treated with the', 'unilateral amblyopia']","['Binocular Dig Rush Game Treatment', 'iPad game', 'dichoptic binocular Dig Rush iPad game plus continued spectacle correction vs. continued spectacle correction alone']","['amblyopic-eye VA', 'mean amblyopic VA', 'amblyopic eye visual acuity (VA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1302981', 'cui_str': 'Prism and cover test'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0442752', 'cui_str': 'Distance vision 6/12'}, {'cui': 'C0442756', 'cui_str': 'Distance vision 6/60'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C1321878', 'cui_str': 'Desmoplastic infantile ganglioglioma'}, {'cui': 'C0443052', 'cui_str': 'Rush'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]","[{'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",182.0,0.339073,"After 4 weeks, mean amblyopic VA improved 1.1 logMAR lines with binocular treatment and 0.6 logMAR lines with spectacles alone (adjusted difference = 0.5 lines; 95.1% CI: 0.1 to 0.9).","[{'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Manny', 'Affiliation': ''}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Holmes', 'Affiliation': 'Department of Ophthalmology and Vision Science, University of Arizona-Tucson, Tucson, Arizona.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Kraker', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Zhuokai', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Waters', 'Affiliation': ""Children's Mercy Hospitals and Clinics, Kansas City, Missouri.""}, {'ForeName': 'Krista R', 'Initials': 'KR', 'LastName': 'Kelly', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Lingkun', 'Initials': 'L', 'LastName': 'Kong', 'Affiliation': 'Texas Tech University Health Science Center, Lubbock, Texas.'}, {'ForeName': 'Earl R', 'Initials': 'ER', 'LastName': 'Crouch', 'Affiliation': 'Virginia Pediatric Eye Center, Virginia Beach, Virginia.'}, {'ForeName': 'Ingryd J', 'Initials': 'IJ', 'LastName': 'Lorenzana', 'Affiliation': 'Advanced Vision Center, Schaumburg, Illinois.'}, {'ForeName': 'Maan S', 'Initials': 'MS', 'LastName': 'Alkharashi', 'Affiliation': ""Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Galvin', 'Affiliation': 'Eye Physicians & Surgeons, PC, Milford, Connecticut.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Rice', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, Ohio.""}, {'ForeName': 'B Michele', 'Initials': 'BM', 'LastName': 'Melia', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Cotter', 'Affiliation': 'Southern California College of Optometry at Marshall B Ketchum University, Fullerton, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001867']
1720,35087117,Assessment of 5-year outcomes of life satisfaction in survivors after rehabilitation programs: a multicenter clinical trial.,"Using a rehabilitation program for the survivors of acute respiratory distress syndrome (ARDS) could be one of the important and fundamental steps to improve the pulmonary function and health-related quality of life (HRQoL) of patients. This study was carried out to evaluate the effect of two rehabilitation techniques (Family-Based Empowerment Model (FECM)/Continuing Care Model (CCM), or both of them) on pulmonary function, and HRQoL in ARDS survivors. From December 2009 to June 2016, ARDS survivors from mixed medical-surgical ICUs at four academic teaching hospitals in Tehran, Iran, were randomly assigned to one of three intervention groups (A, B, or C) or a control group (D). Pre- and post-interventions, pulmonary functions and HRQoL status of patients in all groups were collected 48 times via clinical measurements and various questionnaires during 5 years of follow-up. Significantly improvement was seen in the intervention groups compared to the control group, and the greatest benefit was observed in patients who received mixed of FCEM and CCM rehabilitation techniques. Co-administration of FCEM and CCM can improve pulmonary function as well as the life satisfaction of ARDS survivors. As a result, the execution of the empowerment model by nurses is recommended for ARDS survivors and the participation of their families at the same time.Trial registration: NCT02787720 (ClinicalTrial.gov, 24/05/2016).",2022,"Significantly improvement was seen in the intervention groups compared to the control group, and the greatest benefit was observed in patients who received mixed of FCEM and CCM rehabilitation techniques.","['From December 2009 to June 2016, ARDS survivors from mixed medical-surgical ICUs at four academic teaching hospitals in Tehran, Iran', 'survivors after rehabilitation programs', 'survivors of acute respiratory distress syndrome (ARDS']","['two rehabilitation techniques (Family-Based Empowerment Model (FECM)/Continuing Care Model (CCM', 'FCEM and CCM', 'FCEM', 'rehabilitation program']",['pulmonary function'],"[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",,0.0106938,"Significantly improvement was seen in the intervention groups compared to the control group, and the greatest benefit was observed in patients who received mixed of FCEM and CCM rehabilitation techniques.","[{'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Rahimi-Bashar', 'Affiliation': 'Department of Anesthesiology and Critical Care, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Salesi', 'Affiliation': 'Chemical Injuries Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Keivan', 'Initials': 'K', 'LastName': 'Gohari-Moghadam', 'Affiliation': 'Medical ICU and Pulmonary Unit, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Fathi', 'Initials': 'AF', 'LastName': 'Jouzdani', 'Affiliation': 'Student Research Committee, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mohamad Amin', 'Initials': 'MA', 'LastName': 'Pourhoseingholi', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Vahedian-Azimi', 'Affiliation': 'Trauma Research Center, Nursing Faculty, Baqiyatallah University of Medical Sciences, Sheykh Bahayi Street, Vanak Square, P.O. Box 19575-174, Tehran, Iran. Amirvahedian63@gmail.com.'}]",Scientific reports,['10.1038/s41598-022-05355-z']
1721,35019769,The Impact of Mouthwash on the Oropharyngeal Microbiota of Men Who Have Sex with Men: a Substudy of the OMEGA Trial.,"Mouthwash is a commonly used product and has been proposed as an alternative intervention to prevent gonorrhea transmission. However, the long-term effects of mouthwash on the oral microbiota are largely unknown. We investigated the impact of 12 weeks of daily mouthwash use on the oropharyngeal microbiota in a subset of men who have sex with men who participated in a randomized trial comparing the efficacy of two alcohol-free mouthwashes for the prevention of gonorrhea. We characterized the oropharyngeal microbiota using 16S rRNA gene sequencing of tonsillar fossae samples collected before and after 12 weeks of daily use of Listerine mouthwash or Biotène dry mouth oral rinse. Permutational multivariate analysis of variance (PERMANOVA) was used to assess differences in oropharyngeal microbiota composition following mouthwash use. Differential abundance testing was performed using ALDEx2, with false-discovery rate correction. A total of 306 samples from 153 men were analyzed (Listerine,  n  = 78 and Biotène,  n  = 75). There was no difference in the overall structure of the oropharyngeal microbiota following Listerine or Biotène use (PERMANOVA  P  = 0.413 and  P  = 0.331, respectively). Although no bacterial taxa were significantly differentially abundant following Listerine use, we observed a small but significant decrease in the abundance of both  Streptococcus  and  Leptotrichia  following Biotène use. Overall, our findings suggest that daily use of antiseptic mouthwash has minimal long-term effects on the composition of the oropharyngeal microbiota.  IMPORTANCE  Given the role of the oral microbiota in human health, it is important to understand if and how external factors influence its composition. Mouthwash use is common in some populations, and the use of antiseptic mouthwash has been proposed as an alternative intervention to prevent gonorrhea transmission. However, the long-term effect of mouthwash use on the oral microbiota composition is largely unknown. We found that daily use of two different commercially available mouthwashes had limited long-term effects on the composition of the oropharyngeal microbiota over a 12-week period. The results from our study and prior studies highlight that different mouthwashes may differentially affect the oral microbiome composition and that further studies are needed to determine if mouthwash use induces short-term changes to the oral microbiota that may have detrimental effects.",2022,"There was no difference in the overall structure of the oropharyngeal microbiota following Listerine or Biotène use (PERMANOVA  P  = 0.413 and  P  = 0.331, respectively).","['A total of 306 samples from 153 men were analyzed (Listerine,  n \u2009=\u200978 and Biotène,  n \u2009=\u200975', 'Who Have Sex with Men', 'oropharyngeal microbiota in a subset of men who have sex with men who participated', 'Men']","['alcohol-free mouthwashes', 'antiseptic mouthwash', 'Listerine mouthwash or Biotène dry mouth oral rinse']","['oropharyngeal microbiota composition', 'abundance of both  Streptococcus  and  Leptotrichia', 'overall structure of the oropharyngeal microbiota']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0065081', 'cui_str': 'Listerine'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0065081', 'cui_str': 'Listerine'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}]","[{'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0348061', 'cui_str': 'Leptotrichia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",153.0,0.0256445,"There was no difference in the overall structure of the oropharyngeal microbiota following Listerine or Biotène use (PERMANOVA  P  = 0.413 and  P  = 0.331, respectively).","[{'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Plummer', 'Affiliation': ""Centre for Women's Infectious Diseases Research, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Maddaford', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Healthgrid.267362.4, Carlton, Victoria, Australia.'}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'Murray', 'Affiliation': ""Centre for Women's Infectious Diseases Research, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Fairley', 'Affiliation': 'Central Clinical School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Pasricha', 'Affiliation': 'Department of Microbiology and Immunology, The Peter Doherty Institute for Infection and Immunity, The University of Melbournegrid.1008.9, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Mu', 'Affiliation': 'Department of Microbiology and Immunology, The Peter Doherty Institute for Infection and Immunity, The University of Melbournegrid.1008.9, Melbourne, Victoria, Australia.'}, {'ForeName': 'Catriona S', 'Initials': 'CS', 'LastName': 'Bradshaw', 'Affiliation': 'Central Clinical School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Williamson', 'Affiliation': 'Department of Microbiology and Immunology, The Peter Doherty Institute for Infection and Immunity, The University of Melbournegrid.1008.9, Melbourne, Victoria, Australia.'}, {'ForeName': 'Eric P F', 'Initials': 'EPF', 'LastName': 'Chow', 'Affiliation': 'Central Clinical School, Monash University, Melbourne, Victoria, Australia.'}]",Microbiology spectrum,['10.1128/spectrum.01757-21']
1722,35075765,Effect of antibiotic prophylaxis in dental implant surgery: A multicenter placebo-controlled double-blinded randomized clinical trial.,"BACKGROUND


The growing resistance of bacteria to antimicrobial medicines is a global issue and a direct threat to human health. Despite this, antibiotic prophylaxis is often still routinely used in dental implant surgery to prevent bacterial infection and early implant failure, despite unclear benefits. There is a lack of sufficient evidence to formulate clear clinical guidelines and therefore there is a need for well-designed, large-scale randomized controlled trials to determine the effect of antibiotic prophylaxis.
PURPOSE


To compare the effect of a presurgical antibiotic regimen with an identical placebo regimen in healthy or relatively healthy patients receiving dental implants.
MATERIALS AND METHODS


The 474 patients participating in the study were recruited from seven clinics in southern Sweden. We randomized the patients into a test and a placebo group; the study was conducted double-blinded. Preoperatively, the test group received 2 g of amoxicillin and the control group, identical placebo tablets. The primary outcome was implant failure; secondary outcomes were postoperative infections and adverse events. Patients were evaluated at two follow-ups: at 7-14 days and at 3-6 months.
RESULTS


Postoperative evaluations of the antibiotic (n = 238) and the placebo (n = 235) groups noted implant failures (antibiotic group: six patients, 2.5% and placebo group: seven patients, 3.0%) and postoperative infections (antibiotic group: two patients, 0.8% and placebo group: five patients, 2.1%). No patient reported any adverse events. Between-group differences in implant failures and postoperative infections were nonsignificant.
CONCLUSION


Antibiotic prophylaxis in conjunction with implant placement is likely of small benefit and should thus be avoided in most cases, especially given the unabated growth in antibiotic-resistant bacteria.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03412305.",2022,"Between-group differences in implant failures and postoperative infections were nonsignificant.
","['dental implant surgery', '474 patients participating in the study were recruited from seven clinics in southern Sweden', 'healthy or relatively healthy patients receiving dental implants']","['placebo', 'amoxicillin', 'antibiotic prophylaxis', 'placebo tablets', 'presurgical antibiotic regimen']","['implant failure; secondary outcomes were postoperative infections and adverse events', 'postoperative infections', 'implant failures and postoperative infections', 'implant failures', 'adverse events']","[{'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0854676', 'cui_str': 'Failure of implant'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",474.0,0.64028,"Between-group differences in implant failures and postoperative infections were nonsignificant.
","[{'ForeName': 'Palwasha', 'Initials': 'P', 'LastName': 'Momand', 'Affiliation': 'Department of Oral Diagnostics, Faculty of Odontology, Malmö University, Malmö, Sweden.'}, {'ForeName': 'Jonas P', 'Initials': 'JP', 'LastName': 'Becktor', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Oral Medicine, Faculty of Odontology, Malmö University, Malmö, Sweden.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Naimi-Akbar', 'Affiliation': 'Health Technology Assessment-Odontology (HTA-O), Faculty of Odontology, Malmö University, Malmö, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Tobin', 'Affiliation': 'Department of Pharmacology, Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Götrick', 'Affiliation': 'Department of Oral Diagnostics, Faculty of Odontology, Malmö University, Malmö, Sweden.'}]",Clinical implant dentistry and related research,['10.1111/cid.13068']
1723,35078009,Regional trends of minimally invasive radical hysterectomy for cervical cancer and exploration of perioperative outcomes.,"INTRODUCTION


Radical hysterectomy (RH) with bilateral pelvic lymph node dissection is the standard treatment for early stage cervical cancer which can be performed either by an abdominal or a minimally invasive (MIS) approach. In 2018, Ramirez et al. presented their randomized-controlled trial data which demonstrated that patients who were treated with minimally invasive surgical (MIS) radical hysterectomy (RH) had higher rates of locoregional disease recurrence and lower rates of overall survival when compared to patients treated with an abdominal approach. The objective of this study is to examine the trends in management of patients diagnosed with cervical cancer in New York State (NYS) and to analyze their perioperative outcomes.
METHODS


Using the Statewide Planning and Research Cooperative System (SPARCS) Database, patients undergoing RH for early stage cervical cancer in NYS between the years of 2007-2015 were identified and categorized based on surgical approach. Demographic information was collected and multivariable regression was conducted to assess the impact of hysterectomy approach on perioperative outcomes.
RESULTS


In NYS, 5575 patients were treated with RH for early stage cervical cancer with 3257 (58.4%) treated by abdominal RH and 2318 (41.6%) treated with MIS RH. Between the years of 2007 and 2015, patients diagnosed with cervical cancer treated with MIS RH increased from 25.7% to 48.3% respectively. Surgeons performing MIS RH were more likely to be younger (average age 47.1 vs 49.2, p < 0.001) and have less time elapsed from their fellowship graduation (20.37 vs 22.64 years, p < 0.001). Patients who saw high volume doctors (OR 1.95, CI 1.65-2.31) and were seen in high volume facilities (OR 1.40, CI 1.18-1.65) were more likely to undergo MIS RH compared to abdominal RH. Patients who underwent MIS RH were more likely to be discharged home as opposed to acute rehab or nursing facility, when compared to patients treated with abdominal RH (98.5 vs 94.2% p < 0.001). When analyzing perioperativce outcomes, patient undergoing MIS RH had a 85% decrease in length of hospital stay compared to abdominal RH, a 40% reduction in 30-day readmission rates, and a 10% reduction in hospital costs respectively.
DISCUSSION


In our study period, between the years of 2007 and 2015, the number of cervical cancer cases treated with MIS RH increased from 25.7% to 48.3%. MIS techniques led to a reduction in length of hospital stay, patient readmission rates, and hospital costs. Based on recent data from Ramirez et al., preliminary data demonstrated decrease in MIS RH for treatment of cervical cancer after presentation of the LACC trial and our data confirmed these reported trends in NYS. With this change in surgical practice, there will be associated changes in perioperative outcomes. Moreover, for patients diagnosed with cervical cancer with microscopic disease or previous treatment with an excisions procedure, MIS approach should be considered for improvement in perioperative outcomes as long as oncologic outcomes are not compromised.",2022,"Surgeons performing MIS RH were more likely to be younger (average age 47.1 vs 49.2, p < 0.001) and have less time elapsed from their fellowship graduation (20.37 vs 22.64 years, p < 0.001).","['5575 patients were treated with RH for early stage cervical cancer with 3257 (58.4%) treated by abdominal RH and 2318 (41.6%) treated with MIS RH', 'patients diagnosed with cervical cancer with microscopic disease', 'patients undergoing RH for early stage cervical cancer in NYS between the years of 2007-2015 were identified and categorized based on surgical approach', 'early stage cervical cancer', 'patients diagnosed with cervical cancer in New York State (NYS']","['minimally invasive surgical (MIS) radical hysterectomy (RH', 'minimally invasive radical hysterectomy', 'Radical hysterectomy (RH) with bilateral pelvic lymph node dissection']","['locoregional disease recurrence', '30-day readmission rates', 'MIS RH', 'overall survival', 'hospital costs respectively', 'length of hospital stay', 'length of hospital stay, patient readmission rates, and hospital costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449446', 'cui_str': 'Surgical approach'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}]","[{'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",5575.0,0.112248,"Surgeons performing MIS RH were more likely to be younger (average age 47.1 vs 49.2, p < 0.001) and have less time elapsed from their fellowship graduation (20.37 vs 22.64 years, p < 0.001).","[{'ForeName': 'Sharonne', 'Initials': 'S', 'LastName': 'Holtzman', 'Affiliation': 'Icahn School of Medicine at The Mount Sinai Hospital, Department of Obstetrics, Gynecology and Reproductive Sciences, United States. Electronic address: Sharonne.Holtzman@mountsinai.org.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chaoul', 'Affiliation': 'Icahn School of Medicine at The Mount Sinai Hospital, Department of Obstetrics, Gynecology and Reproductive Sciences, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Finkelstein', 'Affiliation': 'Icahn School of Medicine at The Mount Sinai Hospital, Department of Obstetrics, Gynecology and Reproductive Sciences, United States.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Kolev', 'Affiliation': 'Icahn School of Medicine at The Mount Sinai Hospital, Department of Obstetrics, Gynecology and Reproductive Sciences, United States.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Zakashansky', 'Affiliation': 'Icahn School of Medicine at The Mount Sinai Hospital, Department of Obstetrics, Gynecology and Reproductive Sciences, United States.'}]",Cancer epidemiology,['10.1016/j.canep.2021.102095']
1724,35084038,The Effect of Mat Pilates Training Combined With Aerobic Exercise Versus Mat Pilates Training Alone on Blood Pressure in Women With Hypertension: A Randomized Controlled Trial.,"OBJECTIVE


The purpose of this study was to determine the effects of mat Pilates (MP) versus MP plus aerobic exercise (AE) compared with the effects of no intervention on ambulatory blood pressure (BP) in women with hypertension.
METHODS


This 3-arm, parallel-group randomized clinical trial assessed 60 women who had hypertension and were 30 to 59 years old. The intervention lasted 16 weeks, and the participants were allocated into 3 groups: MP only (MP group), MP with alternating bouts of AE on a treadmill (MP + AE group), and control group (CG) with no exercises. Primary outcomes were the effects of the interventions on ambulatory BP assessed in the 24-hour, awake, and asleep periods of analysis.
RESULTS


A 2-way analysis of variance did not reveal statistically significant differences in between-group comparisons in the 24-hour period of analysis for systolic BP (CG vs MP = 3.3 [95% CI = -7.1 to 13.8]; MP vs MP + AE = 0.7 [95% CI = -4 to 5.4]; CG vs MP + AE = 4.0 [95% CI = -5.2 to 13.4]), diastolic BP (CG vs MP = 2.2 [95% CI = -5.6 to 10.0]; MP vs MP + AE = 1.1 [95% CI = -4.3 to 6.5]; CG vs MP + AE = 3.3 [95% CI = -3.8 to 10.4]), and heart rate (CG vs MP = 3.4 [95% CI = -2 to 8.8]; MP vs MP + AE = 2.0 [95% CI = -3.4 to 7.5]; CG vs MP + AE = 5.4 [95% CI = -0.8 to 11.8]). The awake and asleep periods of analyses also showed similar behavior and did not reveal statistically significant between-group differences. Furthermore, in the responsiveness analysis based on the minimal clinically important difference, no differences were observed between groups.
CONCLUSION


The magnitudes of the decrease in systolic BP during the 24-hour period of analysis were -3 and -5.48 mm Hg for the MP and MP + AE groups, without differences for responsiveness between groups. The results suggest that MP supplemented with AE or not may be an alternative adjuvant treatment for women who have hypertension and are using antihypertension medication.
IMPACT


Sixteen weeks of MP training reduced ambulatory BP in women who had hypertension. The MP + AE group displayed a BP reduction similar to that of the MP group. A reduction in ambulatory BP can decrease the risk of cardiovascular disease.",2022,The awake and asleep periods of analyses also showed similar behavior and did not reveal statistically significant between-group differences.,"['women with hypertension', 'Women with Hypertension', 'women who had hypertension', '60 women who had hypertension and were 30 to 59\xa0years old', 'women who have hypertension and are using antihypertension medication']","['mat Pilates only (MP group), mat Pilates with alternating bouts of AE on a treadmill (MP\u2009+\u2009AE group), and control group (CG), with no exercises', 'MP training', 'mat Pilates (MP) versus MP plus aerobic exercise (AE', 'no intervention', 'Mat Pilates Training Combined with Aerobic Exercise Versus Mat Pilates Training Alone']","['heart rate', 'BP reduction', 'systolic BP', 'ambulatory blood pressure (BP', 'ambulatory BP assessed in the 24-hour, awake, and asleep periods of analysis', 'diastolic BP', 'ambulatory BP', 'risk of cardiovascular disease', 'Blood Pressure']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",60.0,0.146047,The awake and asleep periods of analyses also showed similar behavior and did not reveal statistically significant between-group differences.,"[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'da Silva Almeida', 'Affiliation': 'Graduate Program in Rehabilitation Science, Faculdade de Ceilândia, Universidade de Brasília, Ceilândia, Distrito Federal, Brazil.'}, {'ForeName': 'Letícia', 'Initials': 'L', 'LastName': 'de Souza Andrade', 'Affiliation': 'Physiotherapy School Clinic, Physiotherapy Department, Universidade Católica de Brasília, Taguatinga, Distrito Federal, Brazil.'}, {'ForeName': 'Alessandra Martins Melo', 'Initials': 'AMM', 'LastName': 'de Sousa', 'Affiliation': 'Graduate Program in Rehabilitation Science, Faculdade de Ceilândia, Universidade de Brasília, Ceilândia, Distrito Federal, Brazil.'}, {'ForeName': 'Gerson Cipriano', 'Initials': 'GC', 'LastName': 'Junior', 'Affiliation': 'Graduate Program in Rehabilitation Science, Faculdade de Ceilândia, Universidade de Brasília, Ceilândia, Distrito Federal, Brazil.'}, {'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Turri-Silva', 'Affiliation': 'Graduate Program in Sciences and Technology, Faculdade de Ceilândia, Universidade de Brasília, Ceilândia, Distrito Federal, Brazil.'}, {'ForeName': 'Dahan da', 'Initials': 'DD', 'LastName': 'Cunha Nascimento', 'Affiliation': 'Graduate Program in Physical Education, Physical Education Department, Universidade Católica de Brasília, Taguatinga, Distrito Federal, Brazil.'}, {'ForeName': 'Yomara Lima', 'Initials': 'YL', 'LastName': 'Mota', 'Affiliation': 'Physiotherapy School Clinic, Physiotherapy Department, Universidade Católica de Brasília, Taguatinga, Distrito Federal, Brazil.'}, {'ForeName': 'João Luiz Quagliotti', 'Initials': 'JLQ', 'LastName': 'Durigan', 'Affiliation': 'Graduate Program in Rehabilitation Science, Faculdade de Ceilândia, Universidade de Brasília, Ceilândia, Distrito Federal, Brazil.'}]",Physical therapy,['10.1093/ptj/pzab258']
1725,35085742,"Clinical efficacy of Shugan granule in the treatment of mixed anxiety-depressive disorder: A multicenter, randomized, double-blind, placebo-controlled trial.","ETHNOPHARMACOLOGICAL RELEVANCE


Shugan granule is derived from Xiaoyao powder, a traditional Chinese medicine that has been shown to be effective in treating emotional disorders. At present, there is no standard drug treatment for mixed anxiety-depressive disorder (MADD), and no evidence-based clinical trial has been performed for any drug, meaning MADD patients are unable to obtain standardized treatment.
AIM OF THE STUDY


The purpose of this clinical trial was to test the clinical efficacy and safety of Shugan granules in the treatment of MADD, and to provide clinical trial-based support along with drug recommendations for the treatment of MADD.
MATERIALS AND METHODS


A multicenter, randomized, double-blind, placebo-controlled study was conducted on 400 patients with MADD recruited from January 1, 2019 to December 31, 2020, and they were randomly divided into test and placebo groups with a 1:1 ratio. Subjects in the test group (n = 200) received oral administration of Shugan granules, while subjects in the placebo group (n = 200) received oral administration of a Shugan granule simulator. The treatment lasted for 8 weeks. The Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale-17 (HAMD-17), Clinical Global Impression Scale (CGIS), Self-rating Anxiety Scale (SAS), and Self-rating Depression Scale (SDS) were used to evaluate efficacy. In addition, the traditional Chinese medicine (TCM) syndrome scale for MADD was developed to observe improvements of related symptoms in patients after treatment based on the disease guidelines of TCM and the clinical manifestations of depression. Furthermore, the safety of Shugan granules was evaluated during and after treatment.
RESULTS


After 8 weeks of treatment, the total scores for HAMA, HAMD, SAS, and SDS in the test group were significantly lower than those in the placebo group (P < 0.01). The proportion of patients with efficacy index (EI) > 1 for the CGIS score in the test group was significantly higher than that in the placebo group (P < 0.01). The efficacy of treatment in the test group based on the TCM syndrome scale was 70.16% and 88.27% after 4 weeks and 8 weeks, respectively, which was significantly higher than that in the placebo group (44.27% and 66.67% after 4 weeks and 8 weeks, respectively; P < 0.01). The disappearance rate of single symptoms in the test group was 20-30% higher than that in the placebo group, with a significant difference between groups (P < 0.05). During the treatment period, the incidence of adverse reactions was 2.05% in the test group and 2.06% in the placebo group, with no significant differences noted (P = 1.0000).
CONCLUSION


Shugan granule was more effective than placebo in the treatment of MADD. Moreover, there was no significant difference between the two groups in terms of safety. This paper provides a clinical therapeutic regime using Shugan granule for the treatment of MADD.",2022,"The disappearance rate of single symptoms in the test group was 20-30% higher than that in the placebo group, with a significant difference between groups (P < 0.05).","['mixed anxiety-depressive disorder', '400 patients with MADD recruited from January 1, 2019 to December 31, 2020, and they']","['Shugan granule', 'oral administration of a Shugan granule simulator', 'oral administration of Shugan granules, while subjects in the placebo', 'placebo']","['TCM syndrome scale', 'disappearance rate of single symptoms', 'Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale-17 (HAMD-17), Clinical Global Impression Scale (CGIS), Self-rating Anxiety Scale (SAS), and Self-rating Depression Scale (SDS', 'safety of Shugan granules', 'safety', 'proportion of patients with efficacy index (EI)\u202f>\u202f1 for the CGIS score', 'total scores for HAMA, HAMD, SAS, and SDS', 'incidence of adverse reactions']","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",400.0,0.314834,"The disappearance rate of single symptoms in the test group was 20-30% higher than that in the placebo group, with a significant difference between groups (P < 0.05).","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, 100010, Beijing, China.'}, {'ForeName': 'Liqi', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Beijing Kangpaite Pharmaceutical Technology Development Co., Ltd, 100012, Beijing, China.'}, {'ForeName': 'Rongjuan', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Dongfang Hospital Beijing University of Chinese Medicine, 100078, Beijing, China. Electronic address: dfguorongjuan@163.com.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Handan First Hospital, 056000, Handan, China.'}, {'ForeName': 'Xinping', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Handan First Hospital, 056000, Handan, China.'}, {'ForeName': 'Baoshen', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Luohe Hospital of Traditional Chinese Medicine, 462000, Luohe, China.'}, {'ForeName': 'Qiufeng', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Luohe Hospital of Traditional Chinese Medicine, 462000, Luohe, China.'}, {'ForeName': 'Zengxiang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Nanyang Hospital of Traditional Chinese Medicine, 473003, Nanyang, China.'}, {'ForeName': 'Huixin', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Nanyang Hospital of Traditional Chinese Medicine, 473003, Nanyang, China.'}, {'ForeName': 'Qile', 'Initials': 'Q', 'LastName': 'Temu', 'Affiliation': 'Inner Mongolia International Mongolian Medical Hospital, 010010, Inner Mongolia, China.'}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Inner Mongolia International Mongolian Medical Hospital, 010010, Inner Mongolia, China.'}, {'ForeName': 'Yurong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Inner Mongolia International Mongolian Medical Hospital, 010010, Inner Mongolia, China.'}, {'ForeName': 'Jinlan', 'Initials': 'J', 'LastName': 'An', 'Affiliation': ""The Second People's Hospital of Gansu Province, 730020, Gansu, China.""}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Heilongjiang Hospital of Traditional Chinese Medicine, 150036, Heilongjiang, China.'}, {'ForeName': 'Anhong', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Mianyang Traditional Chinese Medicine Hospital, 621000, Mianyang, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Handan Hospital of Traditional Chinese Medicine, 056000, Handan, China.'}, {'ForeName': 'Jinlin', 'Initials': 'J', 'LastName': 'Shang', 'Affiliation': 'Heji Hospital Affiliated to Changzhi Medical College, 046000, Changzhi, China.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Ningxia Hui Autonomous Region Hospital of Traditional Chinese Medicine, 750000, Ningxia Hui Autonomous Region, China.'}, {'ForeName': 'Dongdong', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, 610075, Chengdu, China.'}, {'ForeName': 'Jiaming', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Qinzhou Traditional Chinese Medicine Hospital, 535000, Qinzhou, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing Kangpaite Pharmaceutical Technology Development Co., Ltd, 100012, Beijing, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zou', 'Affiliation': 'Technical Center for Drug Research and Evaluation of China Association of Traditional Chinese Medicine, 100700, Beijing, China.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2022.115032']
1726,34921986,Impact of photodynamic therapy as an adjunct to non-surgical periodontal treatment on clinical and biochemical parameters among patients having mild rheumatoid arthritis with periodontitis.,"PURPOSE


To evaluate the efficacy of photodynamic therapy (PDT) as an adjunct to non-surgical periodontal therapy on the clinical periodontal and biochemical parameters among patients with rheumatoid arthritis (RA) having periodontitis.
METHODS


A total of 50 RA patients with periodontitis were included. The subjects were equally divided into two groups: Group A - scaling and root planning (SRP) + PDT; Group B - SRP only, respectively. Plaque score (PS), bleeding on probing (BOP), and pocket depth (PD) were estimated. The biochemical parameters included the assessment of interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and rheumatoid factors (RFs).
RESULTS


Plaque scores and BOP significantly reduced in both the groups at both 6 and 12 weeks with significant difference between both the groups at 6 weeks follow up (p<0.05). On inter-group comparison, there was a statistically significant reduction seen for BOP in Group A at 12 weeks (p<0.001). PD significantly reduced in both the groups at both time points; however, significant reduction was noted for Group A compared to Group B (p<0.01). IL-6 and TNF-α significantly reduced in both the groups at 6 and 12 weeks follow up. However, the proinflammatory cytokine levels significantly reduced in group A as compared to group B at both 6 and 12 weeks (p<0.05). GCF levels of RF did not show any change in either of the groups at either time point or between the groups (p>0.05).
CONCLUSION


PDT significantly reduced the proinflammatory burden in terms of periodontal attachment level and bleeding on probing within the periodontal inflammatory pockets in patients having RA.",2022,"RESULTS


Plaque scores and BOP significantly reduced in both the groups at both 6 and 12 weeks with significant difference between both the groups at 6 weeks follow up (p<0.05).","['patients with rheumatoid arthritis (RA) having periodontitis', '50 RA patients with periodontitis', 'patients having mild rheumatoid arthritis with periodontitis']","['IL-6', 'Group A - scaling and root planning (SRP)\xa0+\xa0PDT', 'photodynamic therapy (PDT', 'photodynamic therapy']","['proinflammatory cytokine levels', 'GCF levels of RF', 'PD', 'Plaque scores and BOP', 'BOP', 'interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and rheumatoid factors (RFs', 'Plaque score (PS), bleeding on probing (BOP), and pocket depth (PD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3693482', 'cui_str': 'Giant cell fibroblastoma'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0035448', 'cui_str': 'Rheumatoid factor'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",50.0,0.0413237,"RESULTS


Plaque scores and BOP significantly reduced in both the groups at both 6 and 12 weeks with significant difference between both the groups at 6 weeks follow up (p<0.05).","[{'ForeName': 'Mohamed Farouk', 'Initials': 'MF', 'LastName': 'Elsadek', 'Affiliation': 'Department of Community Health Sciences, College of Applied Medical Sciences, King Saud University, P.O.Box 10219, Riyadh 11433, Saudi Arabia. Electronic address: mfbadr@ksu.edu.sa.'}, {'ForeName': 'Mohamed Fawzi', 'Initials': 'MF', 'LastName': 'Farahat', 'Affiliation': 'Department of Community Health Sciences, College of Applied Medical Sciences, King Saud University, P.O.Box 10219, Riyadh 11433, Saudi Arabia. Electronic address: mffarahat@ksu.edu.sa.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102698']
1727,35045969,Surgical fixation with K-wires versus casting in adults with fracture of distal radius: DRAFFT2 multicentre randomised clinical trial.,"OBJECTIVE


To assess wrist function, quality of life, and complications in adult patients with a dorsally displaced fracture of the distal radius, treated with either a moulded cast or surgical fixation with K-wires.
DESIGN


Multicentre randomised clinical superiority trial, SETTING: 36 hospitals in the UK National Health Service (NHS).
PARTICIPANTS


500 adults aged 16 or over with a dorsally displaced fracture of the distal radius, randomised after manipulation of their fracture (255 to moulded cast; 245 to surgical fixation).
INTERVENTIONS


Manipulation and moulded cast was compared with manipulation and surgical fixation with K-wires plus cast. Details of the application of the cast and the insertion of the K-wires were at the discretion of the treating surgeon, according to their normal clinical practice.
MAIN OUTCOME MEASURES


The primary outcome measure was the Patient Rated Wrist Evaluation (PRWE) score at 12 months (five questions about pain and 10 about function and disability; overall score out of 100 (best score=0 and worst score=100)). Secondary outcomes were PRWE score at three and six months, quality of life, and complications, including the need for surgery due to loss of fracture position in the first six weeks.
RESULTS


The mean age of participants was 60 years and 417 (83%) were women; 395 (79%) completed follow-up. No statistically significant difference in the PRWE score was seen at 12 months (cast group (n=200), mean 21.2 (SD 23.1); K-wire group (n=195), mean 20.7 (22.3); adjusted mean difference -0.34 (95% confidence interval -4.33 to 3.66), P=0.87). No difference was seen at earlier time points. In the cast group, 33 (13%) of participants needed surgical fixation for loss of fracture position in the first six weeks compared with one revision surgery in the K-wire group (odds ratio 0.02, 95% confidence interval 0.001 to 0.10).
CONCLUSIONS


Among patients with a dorsally displaced distal radius fracture that needed manipulation, surgical fixation with K-wires did not improve patients' wrist function at 12 months compared with a cast.
TRIAL REGISTRATION


ISRCTN registry ISRCTN11980540.",2022,"No statistically significant difference in the PRWE score was seen at 12 months (cast group (n=200), mean 21.2 (SD 23.1); K-wire group (n=195), mean 20.7 (22.3); adjusted mean difference -0.34 (95% confidence interval -4.33 to 3.66), P=0.87).","[' 36 hospitals in the UK National Health Service (NHS', '500 adults aged 16 or over with a dorsally displaced fracture of the distal radius, randomised after manipulation of their fracture (255 to moulded cast; 245 to surgical fixation', 'patients with a dorsally displaced distal radius fracture', 'adult patients with a dorsally displaced fracture of the distal radius, treated with either a moulded cast or surgical fixation with K-wires', 'The mean age of participants was 60 years and 417 (83%) were women; 395 (79%) completed follow-up', 'adults with fracture of distal radius']","['Manipulation and moulded cast was compared with manipulation and surgical fixation with K-wires plus cast', 'Surgical fixation with K-wires versus casting']","[""patients' wrist function"", 'Patient Rated Wrist Evaluation (PRWE) score at 12 months (five questions about pain and 10 about function and disability; overall score out of 100 (best score=0 and worst score=100', 'surgical fixation for loss of fracture position', 'PRWE score', 'PRWE score at three and six months, quality of life, and complications, including the need for surgery due to loss of fracture position', 'wrist function, quality of life, and complications']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0585059', 'cui_str': 'Fracture with displacement'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C1298691', 'cui_str': 'Manipulation of fracture'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0369241', 'cui_str': 'Filamentous fungus'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0369241', 'cui_str': 'Filamentous fungus'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",500.0,0.447349,"No statistically significant difference in the PRWE score was seen at 12 months (cast group (n=200), mean 21.2 (SD 23.1); K-wire group (n=195), mean 20.7 (22.3); adjusted mean difference -0.34 (95% confidence interval -4.33 to 3.66), P=0.87).","[{'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Oxford Trauma and Emergency Care, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Trauma Unit, Kadoorie Centre, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Juul', 'Initials': 'J', 'LastName': 'Achten', 'Affiliation': 'Oxford Trauma and Emergency Care, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Trauma Unit, Kadoorie Centre, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Ooms', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Oxford, UK.'}, {'ForeName': 'May Ee', 'Initials': 'ME', 'LastName': 'Png', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care Building, Oxford, UK.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Cook', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'College of Medicine and Health, South Cloisters, University of Exeter, Exeter, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hedley', 'Affiliation': 'Department of Trauma and Orthopaedics, University Hospital Coventry and Warwickshire NHS Trust, University Hospital Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Dias', 'Affiliation': 'Department of Health Sciences, University of Leicester, George Davies Centre, Leicester, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj-2021-068041']
1728,35077777,Randomized clinical trial of low-dose oral minoxidil for the treatment of female pattern hair loss: 0.25 mg versus 1 mg.,,2022,,['female pattern hair Loss'],['low-dose oral minoxidil'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}]",[],,0.199268,,"[{'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Nascimento E Silva', 'Affiliation': 'Núcleo de Pesquisa e Inovação em Ciências da Saúde (NUPICS), Universidade Federal de Juiz de Fora, Juiz de Fora, Brazil; Clínica Optimize, Juiz de Fora, Brazil. Electronic address: marcellanascimento.dermato@gmail.com.'}, {'ForeName': 'Paulo Müller', 'Initials': 'PM', 'LastName': 'Ramos', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, Universidade Estadual Paulista (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Márcio Roberto', 'Initials': 'MR', 'LastName': 'Silva', 'Affiliation': 'Empresa Brasileira de Pesquisa Agropecuária, Juiz de Fora, Brazil.'}, {'ForeName': 'Rafaella', 'Initials': 'R', 'LastName': 'Nascimento E Silva', 'Affiliation': 'Clínica Optimize, Juiz de Fora, Brazil.'}, {'ForeName': 'Nádia Rezende', 'Initials': 'NR', 'LastName': 'Barbosa Raposo', 'Affiliation': 'Núcleo de Pesquisa e Inovação em Ciências da Saúde (NUPICS), Universidade Federal de Juiz de Fora, Juiz de Fora, Brazil.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2022.01.017']
1729,35066398,Effects of exergame and video game training on cognitive and physical function in older adults: A randomized controlled trial.,"Few studies have simultaneously explored the training effects of exergame and video game. The purpose of this study was to investigate the effects of exergame and video game training on cognitive and physical function in healthy older adults. Eighty-four healthy older adults were randomly assigned to exergame training group, video game training group, and control group. Cognitive and physical function was measured before and after the training. Both training groups improved in verbal memory and aerobic endurance, but the training effects were greater in the exergame training group. The exergame training group also showed significant improvement in lower limb strength and balance. The current study provides evidence that exergame training, incorporating both cognitive engagement and physical activity, exerts greater benefits than cognitively engaging video game training alone. The findings shed lights into the future use of exergame in preventing cognitive and physical function decline in older adults.",2022,"Both training groups improved in verbal memory and aerobic endurance, but the training effects were greater in the exergame training group.","['Eighty-four healthy older adults', 'older adults', 'healthy older adults']","['exergame training group, video game training group, and control group', 'exergame and video game training']","['cognitive and physical function', 'verbal memory and aerobic endurance', 'Cognitive and physical function', 'lower limb strength and balance']","[{'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",84.0,0.00351375,"Both training groups improved in verbal memory and aerobic endurance, but the training effects were greater in the exergame training group.","[{'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Hou', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology, Chinese Academy of Sciences, Beijing, 100101, China; Department of Psychology, University of Chinese Academy of Sciences, Beijing, 100049, China.'}, {'ForeName': 'Hui-Jie', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology, Chinese Academy of Sciences, Beijing, 100101, China; Department of Psychology, University of Chinese Academy of Sciences, Beijing, 100049, China. Electronic address: lihj@psych.ac.cn.'}]",Applied ergonomics,['10.1016/j.apergo.2022.103690']
1730,34954840,Concentration-response relationships of dolutegravir and efavirenz with weight change after starting antiretroviral therapy.,"Dolutegravir is associated with more weight gain than efavirenz in people starting antiretroviral therapy (ART). We investigated the concentration-response relationships of efavirenz and dolutegravir with weight gain. We determined concentration-response relationships of dolutegravir and efavirenz (both combined with tenofovir disoproxil fumarate and emtricitabine) with changes in weight and fat distribution, derived from dual-energy x-ray absorptiometry scans, in a nested study of ART-naïve participants from a randomised controlled trial. Pharmacokinetic parameters used in analyses were efavirenz mid-dosing interval concentrations and estimated dolutegravir area under the concentration-time curve using a population pharmacokinetic model developed in the study population. Study outcomes were percentage changes from baseline to week 48 in weight, and visceral and subcutaneous adipose tissue mass. Pharmacokinetic data were available for 158 and 233 participants in the efavirenz arm and dolutegravir arms respectively; 57.0% were women. On multivariable linear regression there were independent negative associations between efavirenz concentrations and changes in both weight (P < .001) and subcutaneous adipose tissue mass (P = .002). Estimated dolutegravir area under the concentration-time curve up to 24 hours was not associated with change in weight (P = .109) but was negatively associated with change in visceral adipose tissue mass (P = .025). We found an independent negative concentration-response relationship between efavirenz concentrations and weight change in ART-naïve participants. Dolutegravir concentrations were not independently associated with weight change. These findings suggest that weight gain differences between efavirenz and dolutegravir are driven by efavirenz toxicity impairing weight gain rather than by off-target effects of dolutegravir causing weight gain.",2022,Estimated dolutegravir area under the concentration-time curve up to 24 hours was not associated with change in weight (P = .109) but was negatively associated with change in visceral adipose tissue mass (P = .025).,"['people starting antiretroviral therapy (ART', '158 and 233 participants in the efavirenz arm and dolutegravir arms respectively; 57.0% were women', 'ART-naïve participants']","['efavirenz', 'dolutegravir and efavirenz (both combined with tenofovir disoproxil fumarate and emtricitabine', 'dolutegravir and efavirenz', 'efavirenz and dolutegravir with weight gain']","['weight gain', 'Dolutegravir concentrations', 'weight, and visceral and subcutaneous adipose tissue mass', 'visceral adipose tissue mass', 'Estimated dolutegravir area under the concentration-time curve', 'subcutaneous adipose tissue mass']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.11943,Estimated dolutegravir area under the concentration-time curve up to 24 hours was not associated with change in weight (P = .109) but was negatively associated with change in visceral adipose tissue mass (P = .025).,"[{'ForeName': 'Rulan', 'Initials': 'R', 'LastName': 'Griesel', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Aida N', 'Initials': 'AN', 'LastName': 'Kawuma', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Roeland', 'Initials': 'R', 'LastName': 'Wasmann', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Simiso', 'Initials': 'S', 'LastName': 'Sokhela', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Godspower', 'Initials': 'G', 'LastName': 'Akpomiemie', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'W D Francois', 'Initials': 'WDF', 'LastName': 'Venter', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lubbe', 'Initials': 'L', 'LastName': 'Wiesner', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Denti', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Phumla', 'Initials': 'P', 'LastName': 'Sinxadi', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Maartens', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}]",British journal of clinical pharmacology,['10.1111/bcp.15177']
1731,35065365,The effect of an exergame on physical activity among older adults residing in a long-term care facility: A pilot study.,"BACKGROUND


Older adults who engage in arranged residential video games have the potential to gain health benefits such as increase in physical activity beyond purposeful movement with movement-based games.
METHODS


A Nintendo Wii video gaming system was implemented for six-weeks as a physical activity intervention with long-term care residents to determine the impact on exercise benefits/barriers, self-efficacy for exercise, and physical activity levels.
RESULTS


Paired t-tests revealed improvement in exercise benefits/barriers, self-efficacy for exercise, and physical activity levels, albeit none with statistical significance (all p > .05).
CONCLUSIONS


The use of the Nintendo Wii as an intervention to enhance physical activity for older adults in nursing home residents should be considered for use over a longer duration of time with older adults.",2022,"Paired t-tests revealed improvement in exercise benefits/barriers, self-efficacy for exercise, and physical activity levels, albeit none with statistical significance (all p > .05).
","['older adults in nursing home residents', 'older adults residing in a long-term care facility', 'Older adults who engage in arranged residential video games']",[],"['physical activity', 'exercise benefits/barriers, self-efficacy for exercise, and physical activity levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0112994,"Paired t-tests revealed improvement in exercise benefits/barriers, self-efficacy for exercise, and physical activity levels, albeit none with statistical significance (all p > .05).
","[{'ForeName': 'Tomika', 'Initials': 'T', 'LastName': 'Williams', 'Affiliation': 'NC Elder Care, PLLC, 1380 Eastchester Dr. Suite 103, High Point, NC 27265, USA. Electronic address: Twilliams@nceldercare.org.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Kennedy-Malone', 'Affiliation': 'University of North Carolina at Greensboro, Greensboro, NC 27410, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Duke University, Durham, NC, 27708, USA.'}, {'ForeName': 'Emily Coates', 'Initials': 'EC', 'LastName': 'Monge', 'Affiliation': 'University of North Carolina at Greensboro, Greensboro, NC 27410, USA.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2022.01.001']
1732,35042096,Examining a brief measure and observed cutoff scores to identify reward and relief drinking profiles: Psychometric properties and pharmacotherapy response.,"BACKGROUND


Precision medicine approaches attempt to reduce variability in alcohol use disorder (AUD) outcomes by identifying patient characteristics that predict response to a particular treatment. Recent work has examined the extent to which individuals with AUD may seek alcohol to enhance positive experiences (reward drinking) or relieve negative states (relief drinking) and shown that a high reward/low relief phenotype predicts naltrexone treatment response. Yet, limitations of reward/relief drinking measures may hamper efforts to translate findings to clinical practice. We sought to refine a brief measure of reward/relief drinking and develop cutoff scores to identify reward/relief subgroups that predict pharmacotherapy response.
METHODS


The Inventory of Drinking Situations (IDS), used in previous studies to measure reward/relief drinking, was administered to 426 participants (77% male; average age = 45.3) in a clinical trial examining naltrexone and acamprosate.
RESULTS


Item response theory and tests of differential item functioning across sex, age, and alcohol dependence severity were used to create a 10-item measure, titled the Reward and Relief IDS (RR-IDS). Cutoff scores on the RR-IDS for the reward/relief drinking subgroups were identified using latent profile and area under the curve analyses. The cutoff scores demonstrated good construct validity. Individuals in the high reward/low relief subgroup who received naltrexone or acamprosate had a decreased likelihood of heavy drinking (large effect sizes) versus those who received placebo.
CONCLUSIONS


The RR-IDS is a practical measure for identifying reward/relief subgroups and predicting pharmacotherapy response. Pending replication of these findings, the RR-IDS could be a critical precision medicine tool for prescribing AUD medications.",2022,"Individuals in the high reward/low relief subgroup who received naltrexone or acamprosate had a decreased likelihood of heavy drinking (large effect sizes) versus those who received placebo.
",['426 participants (77% male; average age\xa0=\xa045.3) in a clinical trial examining'],"['naltrexone or acamprosate', 'naltrexone and acamprosate']",['likelihood of heavy drinking'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0284941', 'cui_str': 'acamprosate'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",426.0,0.0449121,"Individuals in the high reward/low relief subgroup who received naltrexone or acamprosate had a decreased likelihood of heavy drinking (large effect sizes) versus those who received placebo.
","[{'ForeName': 'Victoria R', 'Initials': 'VR', 'LastName': 'Votaw', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, USA; Center on Alcohol, Substance use, & Addictions, University of New Mexico, Albuquerque, NM, USA. Electronic address: vvotaw@unm.edu.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Mann', 'Affiliation': 'Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Henry R', 'Initials': 'HR', 'LastName': 'Kranzler', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Corey R', 'Initials': 'CR', 'LastName': 'Roos', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Nakovics', 'Affiliation': 'Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, USA; Center on Alcohol, Substance use, & Addictions, University of New Mexico, Albuquerque, NM, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.109257']
1733,35040196,Weight gain trajectories and obesity rates in intensive and conventional treatments of type 1 diabetes from the DCCT compared with a control population without diabetes.,"AIM


Obesity is a significant health issue for participants with type 1 diabetes undergoing intensive diabetes management. The temporal pattern and factors associated with weight gain after treatment initiation remain poorly understood including how weight gain in participants with and without type I diabetes compare. Our aim was to compare weight gain in those receiving intensive (INT) and conventional (CONV) type 1 diabetes treatment to a population without diabetes.
METHODS


Participants included men and women of 18 years and older in the Diabetes Control and Complications Trial (DCCT) randomized to INT (n = 562) or CONV (n = 568) and a prospective, observational cohort without diabetes from the Coronary Artery Development in Young Adults (CARDIA, controls) study (n = 2446). Body mass index (BMI) trajectories and obesity prevalence were compared between groups and candidate metabolic and therapeutic moderators investigated.
RESULTS


Annual weight gain with INT peaked 1.3 years after initiation and was greater than both CONV and controls before and after this peak. Obesity prevalence with INT was lower than controls at baseline, was similar to controls at 2 years and surpassed controls by 5 years. Obesity rates with CONV remained below controls at all time points. Greater annual weight gain in the DCCT was associated with lower haemoglobin A 1c  , higher insulin dose and family history of type 2 diabetes.
CONCLUSIONS


Greater weight gain accompanying INT therapy occurs in two stages, leads to similar or greater obesity rates than controls after 2 years and is primarily modified by glucose control and family history, supportive of a therapeutic-genetic influence on weight trajectories.",2022,Greater annual weight gain in the DCCT was associated with lower haemoglobin,"['Participants included men and women of 18\xa0years and older in the Diabetes Control and Complications Trial (DCCT) randomized to INT (n\xa0=\xa0562) or CONV (n\xa0=\xa0568) and a prospective, observational cohort without diabetes from the Coronary Artery Development in Young Adults (CARDIA, controls) study (n\xa0=\xa02446', 'participants with type 1 diabetes undergoing intensive diabetes management', 'participants with and without type I diabetes compare']","['haemoglobin', 'DCCT', 'intensive (INT) and conventional (CONV']","['annual weight gain', 'weight gain', 'Weight gain trajectories and obesity rates', 'Annual weight gain', 'Obesity rates with CONV', 'Body mass index (BMI) trajectories and obesity prevalence', 'Obesity prevalence with INT', 'obesity rates']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0007144', 'cui_str': 'Cardia structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C4704808', 'cui_str': 'Weight Gain Trajectory'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",,0.040917,Greater annual weight gain in the DCCT was associated with lower haemoglobin,"[{'ForeName': 'Nichole E', 'Initials': 'NE', 'LastName': 'Carlson', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Ken W', 'Initials': 'KW', 'LastName': 'Horton', 'Affiliation': 'HQ USAFA/DFMS, USAF Academy, Colorado, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Hokanson', 'Affiliation': 'Department of Epidemiology, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cleary', 'Affiliation': 'Biostatistics Center, George Washington University, Washington, District of Columbia, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Jacobs', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Brunzell', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Purnell', 'Affiliation': 'Knight Cardiovascular Institute and Division of Endocrinology, Diabetes, and Clinical Nutrition, Department of Medicine, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14794']
1734,35081275,"Mepolizumab improves work productivity, activity limitation, symptoms, and rescue medication use in severe eosinophilic asthma.","Patients with severe eosinophilic asthma experience daily activity limitations and reduced productivity at work. Using anonymized individual patient-level data from two previously conducted randomized, double-blind, placebo-controlled studies (MENSA [GSK ID:115588/NCT01691521]; MUSCA [GSK ID:200862/NCT02281318]), we investigated the effect of mepolizumab on work productivity, activity limitation, symptoms, and rescue medication use. Patient-reported outcomes including Work Productivity and Activity Impairment-General Health (WPAI-GH) scores (impairment percentages, 0%-100%), global activity limitation (scale 1-4), and perceived change in activity limitation (Likert scale 1-7) since the start of the study were analyzed. WPAI-GH scores from MENSA were analyzed post hoc for employed patients using mixed model repeated measures; global activity limitation and perceived change in activity limitation from MUSCA were analyzed by ordinal logistic regression. Mean changes from baseline in daily asthma symptom scores (scale 0-5) and rescue medication use (occasions/day) were also assessed, via a post hoc meta-analysis of MENSA and MUSCA. At study end, WPAI-GH scores indicative of overall work impairment, impairment while working, and activity impairment consistently improved with mepolizumab versus placebo. Overall, 76% versus 54% of patients rated their activity as ""much better,"" ""better,"" or ""slightly better"" since the start of the study with mepolizumab versus placebo. Mepolizumab was associated with numerically larger improvements from baseline in asthma symptoms (treatment difference 0.21-0.29 points) and rescue medication use (treatment difference -0.08 to -0.22 occasions/day) versus placebo. Our results indicate that patients with severe eosinophilic asthma may experience improved activity limitation, work productivity, symptoms, and rescue medication use with mepolizumab.",2022,Mepolizumab was associated with numerically larger improvements from baseline in asthma symptoms (treatment difference 0.21-0.29 points) and rescue medication use (treatment difference -0.08 to -0.22 occasions/day) versus placebo.,"['patients with severe eosinophilic asthma', 'Patients with severe eosinophilic asthma experience daily activity limitations and reduced productivity at work']","['placebo', 'Mepolizumab', 'mepolizumab']","['activity limitation, work productivity, symptoms, and rescue medication', 'WPAI-GH scores', 'work productivity, activity limitation, symptoms, and rescue medication use in severe eosinophilic asthma', 'WPAI-GH scores indicative of overall work impairment, impairment while working, and activity impairment', 'work productivity, activity limitation, symptoms, and rescue medication use', 'daily asthma symptom scores', 'asthma symptoms', 'Work Productivity and Activity Impairment-General Health (WPAI-GH) scores (impairment percentages, 0%-100%), global activity limitation (scale 1-4), and perceived change in activity limitation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034068', 'cui_str': 'Eosinophilic asthma'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0557390', 'cui_str': 'Productivity at work'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0969324', 'cui_str': 'mepolizumab'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034068', 'cui_str': 'Eosinophilic asthma'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.253897,Mepolizumab was associated with numerically larger improvements from baseline in asthma symptoms (treatment difference 0.21-0.29 points) and rescue medication use (treatment difference -0.08 to -0.22 occasions/day) versus placebo.,"[{'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Albers', 'Affiliation': 'Respiratory Medical Franchise, GSK, Raleigh, North Carolina, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Bratton', 'Affiliation': 'Clinical Statistics, GSK, Uxbridge, UK.'}, {'ForeName': 'Necdet B', 'Initials': 'NB', 'LastName': 'Gunsoy', 'Affiliation': 'Value Evidence and Outcomes, GSK, Uxbridge, UK.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Cockle', 'Affiliation': 'Value Evidence and Outcomes, GSK, Brentford, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Alfonso-Cristancho', 'Affiliation': 'Value Evidence and Outcomes, GSK, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Braunstahl', 'Affiliation': 'Department of Pulmonary Medicine, Franciscus Gasthuis and Vlietland, Rotterdam, The Netherlands.'}]",The clinical respiratory journal,['10.1111/crj.13474']
1735,35081440,Influence of the Number of Pecking Motions at Working Length on the Shaping Ability of Single-file Systems in Long Oval-shaped Curved Canals.,"INTRODUCTION


The present study compared the effect of the number of pecking motions at the working length (WL) on the shaping ability of single-file systems in long oval-shaped curved root canals.
METHODS


Single-rooted mandibular premolars with long oval-shaped curved canals (25°-35°) were prescanned using micro-computed tomographic imaging, anatomically paired, and randomly divided into 3 groups (n = 15): XP-endo Shaper (XPS; FKG Dentaire, La Chaux-de-Fonds, Switzerland), Reciproc Blue (RB; VDW, Munich, Germany), and WaveOne Gold (WOG; Dentsply Sirona, Ballaigues, Switzerland). After preparation to the WL, each specimen underwent 1, 2, 4, 10, or 20 pecking motions to the WL and was rescanned. Morphologic parameters were measured and analyzed using a 2-factor repeated measures analysis of variance and the Scheirer-Ray-Hare test.
RESULTS


The minor apical diameter and percentage increase in canal volume increased with the number of pecking motions, whereas the percentage of unprepared canal surface area decreased (P < .05). The mean minor diameters (in mm) at D0 varied between 0.29 and 0.35 after 4 pecking motions with the RB and WOG systems and between 0.35 and 0.36 after 10 pecking motions with the XPS system. No significant differences in canal transportation or centering ratio were observed among the groups at the levels of canal curvature and canal thirds (P > .05).
CONCLUSIONS


Increasing the number of pecking motions improves the cutting efficacy of single-file systems without adversely altering the anatomic characteristics of oval-shaped curved canals. No more than 4 pecking motions for the RB and WOG systems and 10 pecking motions for the XPS system appear to be acceptable for the shaping of these difficult to clean root canals.",2022,"No significant differences in canal transportation or centering ratio were observed among the 3 groups at the levels of canal curvature and canal-thirds (P>0.05).
",['Single-rooted mandibular premolars with long oval-shaped curved canals (25-35°) were'],"['XP-endo Shaper (XPS), Reciproc Blue (RB) and WaveOne Gold (WOG', 'pre-scanned using micro-computed tomography (micro-CT', 'number of pecking motions at working length (WL']","['canal transportation or centering ratio', 'canal volume', 'mean minor diameters', 'percentage of unprepared canal surface area']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}]","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C4082133', 'cui_str': 'Not prepared'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.0675583,"No significant differences in canal transportation or centering ratio were observed among the 3 groups at the levels of canal curvature and canal-thirds (P>0.05).
","[{'ForeName': 'Lixiao', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Hospital of Stomatology, Guanghua School of Stomatology, Sun Yat-sen University, Guangzhou, PR China; Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, PR China.'}, {'ForeName': 'Ruitian', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Hospital of Stomatology, Guanghua School of Stomatology, Sun Yat-sen University, Guangzhou, PR China; Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, PR China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Hospital of Stomatology, Guanghua School of Stomatology, Sun Yat-sen University, Guangzhou, PR China; Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, PR China.'}, {'ForeName': 'Zihan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Hospital of Stomatology, Guanghua School of Stomatology, Sun Yat-sen University, Guangzhou, PR China; Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, PR China.'}, {'ForeName': 'Franklin R', 'Initials': 'FR', 'LastName': 'Tay', 'Affiliation': 'Department of Endodontics, The Dental College of Georgia, Augusta University, Augusta, Georgia. Electronic address: ftay@augusta.edu.'}, {'ForeName': 'Lisha', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': 'Hospital of Stomatology, Guanghua School of Stomatology, Sun Yat-sen University, Guangzhou, PR China; Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, PR China. Electronic address: gulisha@mail.sysu.edu.cn.'}]",Journal of endodontics,['10.1016/j.joen.2022.01.009']
1736,35081360,Electronic health record-embedded decision support to reduce stroke risk in patients with atrial fibrillation - Study protocol.,"BACKGROUND


Atrial fibrillation (AF) is the most common significant cardiac rhythm disorder and is a powerful common risk factor for stroke. Randomized trials have demonstrated that anticoagulation can reduce the risk of stroke in patients with AF. Yet, there continues to be widespread underutilization of this therapy. To address this practice gap locally and improve efforts to reduce the risk of stroke for patients with AF in our health system, we have designed a study to implement and evaluate the effectiveness of an Atrial Fibrillation Decision Support Tool (AFDST) embedded within our electronic health record.
METHODS


Our intervention is provider-facing and focused on decision support. The clinical setting is ambulatory patients being seen by primary care physicians. Patients include those with both incident and prevalent AF. This randomized, prospective trial will enroll 800 patients in our University of Cincinnati Health System who are currently receiving less than optimal anticoagulation therapy as determined by the AFDST. Patients will be randomized to one of two arms - 1) usual care, in which the AFDST is available for use; 2) addition of a best practice advisory (BPA) to the AFDST notifying the clinician that their patient stands to gain a significant benefit from a change in their current thromboprophylactic therapy.
RESULTS


The primary outcome is effectiveness of the BPA measured by change to ""appropriate thromboprophylaxis"" based on the AFDST recommendation at 3 months post randomization. Secondary endpoints include Reach and Adoption, from the RE-AIM framework for implementation studies. Sample size is based upon an improvement from inappropriate to appropriate anticoagulation therapy estimated at 4% in the usual care arm and ≥10% in the experimental arm.
CONCLUSION


Our goal is to examine whether addition of a BPA to an AFDST focused on primary care physicians in an ambulatory care setting will improve ""appropriate thromboprophylaxis"" compared with usual care. Results will be examined at 3 months post randomization and at the end of the study to evaluate durability of changes. We expect to complete patient enrollment by the end of June 2022.
TRIAL REGISTRATION


Clinicaltrials.gov NCT04099485.",2022,"To address this practice gap locally and improve efforts to reduce the risk of stroke for patients with AF in our health system, we have designed a study to implement and evaluate the effectiveness of an Atrial Fibrillation Decision Support Tool (AFDST) embedded within our electronic health record (EHR).","['800 patients in our University of Cincinnati Health System who are currently receiving less than optimal anticoagulation therapy as determined by the AFDST', 'ambulatory patients being seen by primary care physicians', 'patients with AF in our health system', 'Patients with Atrial Fibrillation - Study Protocol', 'patients with AF']",[],"['effectiveness of the BPA measured by change to ""appropriate thromboprophylaxis"" based on the AFDST recommendation', 'Reach and Adoption, from the RE-AIM framework for implementation studies', 'Stroke Risk']","[{'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3887420', 'cui_str': 'Seen by primary care physician'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0053800', 'cui_str': 'bisphenol A'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}]",,0.0466683,"To address this practice gap locally and improve efforts to reduce the risk of stroke for patients with AF in our health system, we have designed a study to implement and evaluate the effectiveness of an Atrial Fibrillation Decision Support Tool (AFDST) embedded within our electronic health record (EHR).","[{'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Eckman', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH. Electronic address: mark.eckman@uc.edu.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Knochelmann', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Mardis', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Wright', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Gummadi', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Estrelita', 'Initials': 'E', 'LastName': 'Dixon', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Becker', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Schauer', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Flaherty', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Costea', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Kleindorfer', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Ireton', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Baker', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Brett M', 'Initials': 'BM', 'LastName': 'Harnett', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Adeboye', 'Initials': 'A', 'LastName': 'Adejare', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Leonard', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Sucharew', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Costanzo', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Arduser', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kues', 'Affiliation': 'Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}]",American heart journal,['10.1016/j.ahj.2022.01.012']
1737,35081775,"Comprando Rico y Sano : Increasing Latino Nutrition Knowledge, Healthful Diets, and Food Access Through a National Community-Based Intervention.","PURPOSE


Evaluation findings from  Comprando Rico y Sano  (CRS), a culturally relevant, community-based intervention addressing nutrition knowledge and food access are presented.
DESIGN


No-control quasi-experimental intervention with pre, post, and follow-up assessments.
SETTING


CRS was  promotores -led through UnidosUS's Affiliate Network of community-based partners.
SAMPLE


Low-income Latino adults (N = 966) receiving services at 25 partner sites.
INTERVENTION


CRS was a six-hour intervention focused on nutrition knowledge and consumption of fruits, vegetables, and home-prepared meals. It also provided guidance for health-conscious grocery shopping, Supplemental Nutrition Assistance Program (SNAP) information, and enrollment assistance.
MEASURES


Self-report surveys assessed nutrition knowledge; intention to change; and frequency of fruit, vegetable, and home-prepared meal consumption. Sites reported monthly SNAP enrollment data.
ANALYSIS


Paired-samples t-tests and repeated-measures ANOVAs assessed changes in knowledge, intentions, and behavior from pre-to-post (n = 960) and pre-to-follow-up (n = 115).
RESULTS


Pre-to-follow-up increases in nutrition knowledge (P < .001) were observed. Intention to consume more vegetables (P = .027) and home-prepared meals (P < .001) also improved between pre- and follow-up. Increases from pre-to-follow-up were observed for frequency of consuming fruits (P = .007), vegetables (P = .001), and home-prepared meals (P < .001). Across 16 months, 24,359 Latinos enrolled for SNAP.
CONCLUSION


Large-scale community collaborations to deliver culturally relevant nutrition education and SNAP enrollment assistance can increase food access, health literacy, and promote healthful diets for Latinos.",2022,Intention to consume more vegetables (p=.027) and home-prepared meals (p<.001) also improved between pre and follow-up.,"['24,359 Latinos enrolled for SNAP', 'SAMPLE\n\n\nLow-income Latino adults (N=966) receiving services at 25 partner sites']","['Comprando Rico', 'nutrition knowledge and consumption of fruits, vegetables, and home-prepared meals']","['nutrition knowledge', 'knowledge, intentions, and behavior', 'Self-report surveys assessed nutrition knowledge; intention to change; and frequency of fruit, vegetable, and home-prepared meal consumption']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C3494397', 'cui_str': 'SNAP Program'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4082130', 'cui_str': 'Prepared'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1290962', 'cui_str': 'Preparing meals'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",24359.0,0.0156138,Intention to consume more vegetables (p=.027) and home-prepared meals (p<.001) also improved between pre and follow-up.,"[{'ForeName': 'Mayra S', 'Initials': 'MS', 'LastName': 'Rascón', 'Affiliation': 'Center for Latino Community Health, Evaluation, and Leadership Training, Department of Health Science, 14668California State University Long Beach, CA, USA.'}, {'ForeName': 'Melawhy L', 'Initials': 'ML', 'LastName': 'Garcia', 'Affiliation': 'Center for Latino Community Health, Evaluation, and Leadership Training, Department of Health Science, 14668California State University Long Beach, CA, USA.'}, {'ForeName': 'Selena T', 'Initials': 'ST', 'LastName': 'Nguyen-Rodriguez', 'Affiliation': 'Center for Latino Community Health, Evaluation, and Leadership Training, Department of Health Science, 14668California State University Long Beach, CA, USA.'}, {'ForeName': 'Gino', 'Initials': 'G', 'LastName': 'Galvez', 'Affiliation': 'Department of Psychology, 14668California State University Long Beach, CA, USA.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Gepp', 'Affiliation': 'RinggoldID:8294Institute for Hispanic Health, UnidosUS, DC, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Carrillo', 'Affiliation': 'RinggoldID:8294Institute for Hispanic Health, UnidosUS, DC, USA.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Carreon', 'Affiliation': 'RinggoldID:8294Institute for Hispanic Health, UnidosUS, DC, USA.'}]",American journal of health promotion : AJHP,['10.1177/08901171211073956']
1738,35082253,Noninvasive vagus nerve stimulation modulates trigeminal but not extracephalic somatosensory perception: functional evidence for a trigemino-vagal system in humans.,"ABSTRACT


Noninvasive vagus nerve stimulation (nVNS) is effective in several types of headache disorders. We sought to unravel the mechanism of how nVNS exhibits this efficacy. This study used a randomized, single-blind, sham-controlled, crossover design and comprised 3 projects with 3 independent cohorts of healthy participants. Project I (n = 15) was explorative. Six quantitative sensory test parameters, including mechanical pain threshold (MPT), were measured over the left V1 dermatome and forearm and compared before and after unilateral nVNS. Projects II (n = 20) and III (n = 21) were preregistered online (https://osf.io/r4jb9). Quantitative sensory test parameters were compared over the left (Project II) or bilateral V1 and V3 dermatomes (Project III), respectively, in addition to the left forearm as a control. A secondary analysis of heart rate variability (HRV) using a historical control group was used to control for systemic effects of nVNS. Verum-nVNS induced trigeminal-specific modulation of pain threshold (ie, MPT) over the left V1 in Project I, left V1 and V3 in Project II, and bilateral V1 and V3 in Project III. Data pooled from Projects II and III demonstrated a greater increase in MPT in the V1 vs V3 dermatome. There were no differences associated with sham-nVNS in any projects. Heart rate variability parameters did not change after nVNS. Our results provide functional evidence of a long hypothesized functional trigemino-vagal system in humans and may explain why nVNS is effective in some headache disorders but not in somatic pain disorders. Because unilateral nVNS modulated the trigeminal thresholds bilaterally, this effect is probably indirect through a central top-down mechanism.",2022,"Since unilateral nVNS modulated the trigeminal thresholds bilaterally, this effect is probably indirect through a central top-down mechanism.","['three projects with three independent cohorts of healthy participants', 'humans']","['Verum-nVNS', 'invasive vagus nerve stimulation (nVNS']","['QST parameters', 'Six quantitative sensory test (QST) parameters, including mechanical pain threshold (MPT', 'heart rate variability (HRV', 'HRV parameters', 'MPT']","[{'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0285352,"Since unilateral nVNS modulated the trigeminal thresholds bilaterally, this effect is probably indirect through a central top-down mechanism.","[{'ForeName': 'Kuan-Po', 'Initials': 'KP', 'LastName': 'Peng', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'May', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000002595']
1739,35083495,Local Hyperthermia Versus Cryotherapy for Treatment of Plantar Warts: A Prospective Multi-centre Non-randomized Concurrent Controlled Clinical Trial.,"Cryotherapy is one of the most common treatments for warts; however, pain during treatment and relatively high recurrence rates limit its use. Local hyperthermia has also been used successfully in the treatment of plantar warts. The aim of this study was to compare the clinical effectiveness of local hyperthermia vs cryotherapy for the treatment of plantar warts. This multi- centre, open, 2-arm, non-randomized concurrent controlled trial included 1,027 patients, who received either cryotherapy or local hyperthermia treatment. Three months after treatment, local hyperthermia and cryotherapy achieved complete clearance rates of 50.9% and 54.3%, respectively. Recurrence rates were 0.8% and 12%, respectively. Pain scores during local hyperthermia were significantly lower than for cryotherapy. Both local hyperthermia and cryotherapy demonstrated similar efficacy for clearance of plantar warts; while local hyperthermia had a lower recurrence rate and lower pain sensation during treatment.",2022,Both local hyperthermia and cryotherapy demonstrated similar efficacy for clearance of plantar warts; while the former had lower recurrence rate and lower pain sensation during the treatments.,"['1027 patients received either', 'Plantar Warts (Verrucae', 'plantar warts']","['Local Hyperthermia at 44\uf0b0C versus Cryotherapy', 'cryotherapy or local hyperthermia treatment', 'Cryotherapy', 'local hyperthermia versus cryotherapy']","['pain scores', 'local hyperthermia and cryotherapy achieved complete clearance rates', 'recurrence rate and lower pain sensation', 'recurrence rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042548', 'cui_str': 'Verruca plantaris'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}]","[{'cui': 'C0020549', 'cui_str': 'Hyperthermia, Local'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0020549', 'cui_str': 'Hyperthermia, Local'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",1027.0,0.0369614,Both local hyperthermia and cryotherapy demonstrated similar efficacy for clearance of plantar warts; while the former had lower recurrence rate and lower pain sensation during the treatments.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huo', 'Affiliation': ''}, {'ForeName': 'Ya-Li', 'Initials': 'YL', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Hong-Yi', 'Initials': 'HY', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Gui-Jiao', 'Initials': 'GJ', 'LastName': 'Bi', 'Affiliation': ''}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': ''}, {'ForeName': 'Yun-Fei', 'Initials': 'YF', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Rui-Qun', 'Initials': 'RQ', 'LastName': 'Qi', 'Affiliation': ''}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lan', 'Affiliation': ''}, {'ForeName': 'Zhi-Rong', 'Initials': 'ZR', 'LastName': 'Yao', 'Affiliation': ''}, {'ForeName': 'Xiu-Ping', 'Initials': 'XP', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Jian-Zhong', 'Initials': 'JZ', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Tian-Wen', 'Initials': 'TW', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': ''}, {'ForeName': 'Ri-Na', 'Initials': 'RN', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Hong-Guang', 'Initials': 'HG', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Fan-Qin', 'Initials': 'FQ', 'LastName': 'Zeng', 'Affiliation': ''}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'YouLin', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': ''}, {'ForeName': 'Xing-Hua', 'Initials': 'XH', 'LastName': 'Gao', 'Affiliation': 'Department of Dermatology, the FirstHospital of China Medical University, Shenyang, Liaoning, China. gaobarry@hotmail.com.'}]",Acta dermato-venereologica,['10.2340/actadv.v102.1082']
1740,35083837,"Effects of acute moderate-intensity aerobic exercise on executive function and prefrontal cortex activity in community-dwelling older adults: A single-blind, randomized controlled trial.","AIM


To date, there is a controversy regarding the effects of acute aerobic exercise of moderate intensity on executive function and prefrontal cortex activity in community-dwelling older adults. This study aimed to investigate the effects of acute aerobic exercise of moderate intensity in healthy older adults.
METHODS


Fifty-six healthy older adults were randomly assigned to the experimental group (EG) that performed moderate-intensity aerobic exercise or the wait-list control group (CG) for a total of 15 sessions. To compare the two groups, the Stroop Color-Word Task (SCWT) and the Trail-Making Test Part B (TMT-B) were implemented for executive function and prefrontal cortex activity during executive function testing.
RESULTS


After the intervention, the EG achieved a significant improvement in the SCWT (P < 0.001; η 2   = 0.196) and the TMT-B (P < 0.001; η 2   = 0.245) compared with the CG. In addition, the EG showed a lower HbO2 concentration in the prefrontal cortex than the CG during the SCWT (P < 0.05; η 2   = 0.076) and the TMT-B (P < 0.05; η 2   = 0.090).
CONCLUSIONS


These findings shed new light on the clinical effectiveness of acute moderate-intensity aerobic exercise on executive function and prefrontal cortex activity in healthy older adults. Geriatr Gerontol Int 2022; 22: 227-232.",2022,"After the intervention, the EG achieved a significant improvement in the SCWT (P < 0.001; η 2   = 0.196) and the TMT-B (P < 0.001; η 2   = 0.245) compared with the CG.","['community-dwelling older adults', 'Fifty-six healthy older adults', 'healthy older adults']","['acute moderate-intensity aerobic exercise', 'intensity aerobic exercise', 'moderate-intensity aerobic exercise or the wait-list control group (CG', 'acute aerobic exercise']","['SCWT', 'executive function and prefrontal cortex activity', 'Stroop Color-Word Task (SCWT) and the Trail-Making Test Part B (TMT-B', 'lower HbO2 concentration']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",56.0,0.0335702,"After the intervention, the EG achieved a significant improvement in the SCWT (P < 0.001; η 2   = 0.196) and the TMT-B (P < 0.001; η 2   = 0.245) compared with the CG.","[{'ForeName': 'Jin-Hyuck', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Occupational Therapy, College of Medical Science, Soonchunhyang University, Asan, South Korea.'}]",Geriatrics & gerontology international,['10.1111/ggi.14352']
1741,35075138,"VEGF-A, VEGFR1 and VEGFR2 single nucleotide polymorphisms and outcomes from the AGITG MAX trial of capecitabine, bevacizumab and mitomycin C in metastatic colorectal cancer.","The phase III MAX clinical trial randomised patients with metastatic colorectal cancer (mCRC) to receive first-line capecitabine chemotherapy alone or in combination with the anti-VEGF-A antibody bevacizumab (± mitomycin C). We utilised this cohort to examine whether single nucleotide polymorphisms (SNPs) in VEGF-A, VEGFR1, and VEGFR2 are predictive of efficacy outcomes with bevacizumab or the development of hypertension. Genomic DNA extracted from archival FFPE tissue for 325 patients (69% of the MAX trial population) was used to genotype 16 candidate SNPs in VEGF-A, VEGFR1, and VEGFR2, which were analysed for associations with efficacy outcomes and hypertension. The VEGF-A rs25648 'CC' genotype was prognostic for improved PFS (HR 0.65, 95% CI 0.49 to 0.85; P = 0.002) and OS (HR 0.70, 95% CI 0.52 to 0.94; P = 0.019). The VEGF-A rs699947 'AA' genotype was prognostic for shorter PFS (HR 1.32, 95% CI 1.002 to 1.74; P = 0.048). None of the analysed SNPs were predictive of bevacizumab efficacy outcomes. VEGFR2 rs11133360 'TT' was associated with a lower risk of grade ≥ 3 hypertension (P = 0.028). SNPs in VEGF-A, VEGFR1 and VEGFR2 did not predict bevacizumab benefit. However, VEGF-A rs25648 and rs699947 were identified as novel prognostic biomarkers and VEGFR2 rs11133360 was associated with less grade ≥ 3 hypertension.",2022,"The VEGF-A rs25648 'CC' genotype was prognostic for improved PFS (HR 0.65, 95% CI 0.49 to 0.85; P = 0.002) and OS (HR 0.70, 95% CI 0.52 to 0.94; P = 0.019).","['metastatic colorectal cancer', 'patients with metastatic colorectal cancer (mCRC']","['capecitabine chemotherapy alone or in combination with the anti-VEGF-A antibody bevacizumab (±\u2009mitomycin C', 'bevacizumab', 'capecitabine, bevacizumab and mitomycin C']",[],"[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]",[],325.0,0.10103,"The VEGF-A rs25648 'CC' genotype was prognostic for improved PFS (HR 0.65, 95% CI 0.49 to 0.85; P = 0.002) and OS (HR 0.70, 95% CI 0.52 to 0.94; P = 0.019).","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Chionh', 'Affiliation': 'Olivia Newton-John Cancer Research Institute, Heidelberg, VIC, 3084, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Sheren J', 'Initials': 'SJ', 'LastName': 'Al-Obaidi', 'Affiliation': 'Olivia Newton-John Cancer Research Institute, Heidelberg, VIC, 3084, Australia.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Mooi', 'Affiliation': 'Olivia Newton-John Cancer Research Institute, Heidelberg, VIC, 3084, Australia.'}, {'ForeName': 'Maressa A', 'Initials': 'MA', 'LastName': 'Bruhn', 'Affiliation': 'Haematology-Oncology Department, Basil Hetzel Institute, The Queen Elizabeth Hospital, Woodville, SA, 5001, Australia.'}, {'ForeName': 'Chee K', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Anderly C', 'Initials': 'AC', 'LastName': 'Chüeh', 'Affiliation': 'Olivia Newton-John Cancer Research Institute, Heidelberg, VIC, 3084, Australia.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Williams', 'Affiliation': 'Olivia Newton-John Cancer Research Institute, Heidelberg, VIC, 3084, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Weickhardt', 'Affiliation': 'Olivia Newton-John Cancer Research Institute, Heidelberg, VIC, 3084, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Scott', 'Affiliation': 'Olivia Newton-John Cancer Research Institute, Heidelberg, VIC, 3084, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Simes', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Hardingham', 'Affiliation': 'Haematology-Oncology Department, Basil Hetzel Institute, The Queen Elizabeth Hospital, Woodville, SA, 5001, Australia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Price', 'Affiliation': 'Haematology-Oncology Department, Basil Hetzel Institute, The Queen Elizabeth Hospital, Woodville, SA, 5001, Australia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Mariadason', 'Affiliation': 'Olivia Newton-John Cancer Research Institute, Heidelberg, VIC, 3084, Australia. john.mariadason@onjcri.org.au.'}, {'ForeName': 'Niall C', 'Initials': 'NC', 'LastName': 'Tebbutt', 'Affiliation': 'Olivia Newton-John Cancer Research Institute, Heidelberg, VIC, 3084, Australia. niall.tebbutt@austin.org.au.'}]",Scientific reports,['10.1038/s41598-021-03952-y']
1742,35055538,Comparison of the Cardiovascular Effects of Extreme Psychological and Physical Stress Tests in Male Soccer Players.,"BACKGROUND


The purpose of our study was to compare the physiological effects of extreme physical and psychological stress tests in male soccer players, since these two types of stress apply to athletes with high performance requirements.
METHODS


A total of 63 healthy male soccer players participated in this study, all of whom underwent both of the tests. A physical stress test was carried out in an exercise physiology laboratory, where subjects completed an incremental treadmill running test to full exhaustion, and a psychological test was performed in a military tactical room, where subjects met a street offence situation. Heart rate variability (HRV) and blood pressure (BP) were recorded directly before, immediately after, and 30 min after the stress tests.
RESULTS


The majority of HRV indices changed significantly in both stress protocols. Inverse, significant changes (positive for the physical test, negative for the psychological test,  p  < 0.001) were found when comparing the alterations of HRV indices between the tests. Significant differences were found in the changes in systolic ( p  = 0.003) and diastolic ( p  < 0.001) BP between the test protocols, and also between the baseline and post-test measurements ( p  < 0.001).
CONCLUSION


Both HRV and BP are sensitive physiological parameters to measure the impact of extreme physical and/or psychological stress.",2022,"Inverse, significant changes (positive for the physical test, negative for the psychological test,  p  < 0.001) were found when comparing the alterations of HRV indices between the tests.","['63 healthy male soccer players', 'athletes with high performance requirements', 'Male Soccer Players', 'male soccer players']",['Extreme Psychological and Physical Stress Tests'],"['majority of HRV indices', 'Heart rate variability (HRV) and blood pressure (BP', 'HRV indices', 'diastolic', 'changes in systolic']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0231302', 'cui_str': 'Physical stress'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",63.0,0.030476,"Inverse, significant changes (positive for the physical test, negative for the psychological test,  p  < 0.001) were found when comparing the alterations of HRV indices between the tests.","[{'ForeName': 'Ákos', 'Initials': 'Á', 'LastName': 'Móra', 'Affiliation': 'Faculty of Health Sciences, University of Pécs, 7621 Pécs, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Komka', 'Affiliation': 'Department of Health Sciences and Sport Medicine, University of Physical Education, 1123 Budapest, Hungary.'}, {'ForeName': 'József', 'Initials': 'J', 'LastName': 'Végh', 'Affiliation': 'International Training Centre, 1126 Budapest, Hungary.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Farkas', 'Affiliation': 'International Training Centre, 1126 Budapest, Hungary.'}, {'ForeName': 'Gyöngyi Szilágyi', 'Initials': 'GS', 'LastName': 'Kocsisné', 'Affiliation': 'I-QRS International Ltd., 1165 Budapest, Hungary.'}, {'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Bosnyák', 'Affiliation': 'Department of Health Sciences and Sport Medicine, University of Physical Education, 1123 Budapest, Hungary.'}, {'ForeName': 'Márta', 'Initials': 'M', 'LastName': 'Szmodis', 'Affiliation': 'Department of Health Sciences and Sport Medicine, University of Physical Education, 1123 Budapest, Hungary.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Ligetvári', 'Affiliation': 'Faculty of Health Sciences, University of Pécs, 7621 Pécs, Hungary.'}, {'ForeName': 'Éva', 'Initials': 'É', 'LastName': 'Csöndör', 'Affiliation': 'Faculty of Health Sciences, University of Pécs, 7621 Pécs, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Almási', 'Affiliation': 'Department of Health Sciences and Sport Medicine, University of Physical Education, 1123 Budapest, Hungary.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Oláh', 'Affiliation': 'Faculty of Health Sciences, University of Pécs, 7621 Pécs, Hungary.'}, {'ForeName': 'Han C G', 'Initials': 'HCG', 'LastName': 'Kemper', 'Affiliation': 'Medical Centers, Amsterdam University, 1081 Amsterdam, The Netherlands.'}, {'ForeName': 'Miklós', 'Initials': 'M', 'LastName': 'Tóth', 'Affiliation': 'Faculty of Health Sciences, University of Pécs, 7621 Pécs, Hungary.'}, {'ForeName': 'Pongrác', 'Initials': 'P', 'LastName': 'Ács', 'Affiliation': 'Faculty of Health Sciences, University of Pécs, 7621 Pécs, Hungary.'}]",International journal of environmental research and public health,['10.3390/ijerph19020715']
1743,35055558,Effects of Personal Low-Frequency Stimulation Device on Myalgia: A Randomized Controlled Trial.,"Electrotherapy is commonly used for myalgia alleviation. Low-frequency stimulation (LFS) is primarily used for controlling acute and chronic pain and is a non-invasive therapy that can be easily performed with electric stimulation applied on the skin. However, little evidence exists regarding the pain alleviation effects of personal low-frequency stimulation device for home use. Moreover, no studies have compared myalgia alleviation effects between personal low-frequency stimulation (PLS) and physical therapy (PT), which are most commonly used for patients with myalgia in hospitals and clinics. Therefore, we aimed to investigate the pain alleviation effects of PLS in patients with myalgia and compare these effects with those of conventional PT (transcutaneous electrical nerve stimulation + ultrasound). In total, 39 patients with myalgia in the neck, shoulder, back, and waist areas were randomly assigned to the personal low-frequency stimulation group (PLSG:  n  = 20) and physical therapy group (PTG:  n  = 19). Both groups were treated for 3 weeks (20 min per session and 5 sessions per week). Patients were assessed for pain intensity by surface electromyography (sEMG), visual analogue scale (VAS) and a short-form McGill pain questionnaire (SF-MPQ) before and after the intervention period. Our results showed that PLSG showed a tendency of muscle relaxation with a significant decrease in sEMG in the neck ( p  = 0.0425), shoulder ( p  = 0.0425), and back ( p  = 0.0046) areas compared to the control group. However, there was no significant difference in waist area. Additionally, VAS scores significantly decreased between pre- and post-treatment in both PTG ( p  = 0.0098), and PLSG ( p  = 0.0304) groups, but there was no significance difference between the groups. With respect to SF-MPQ, the PLSG showed greater pain alleviation (5.23 ± 0.25) effects than the PTG (6.23 ± 0.25). Accordingly, our results suggest that PLS treatment using a home device might offer positive assistance in pain alleviation for patients with myalgia that is as equally effective as conventional PT treatment. However, further detailed studies are required considering larger samples to fully claim the effectiveness of this device.",2022,"Additionally, VAS scores significantly decreased between pre- and post-treatment in both PTG ( p  = 0.0098), and PLSG ( p  = 0.0304) groups, but there was no significance difference between the groups.","['patients with myalgia', '39 patients with myalgia in the neck, shoulder, back, and waist areas', 'patients with myalgia in hospitals and clinics']","['Low-frequency stimulation (LFS', 'PLSG', 'conventional PT (transcutaneous electrical nerve stimulation + ultrasound', 'Personal Low-Frequency Stimulation Device', 'personal low-frequency stimulation group (PLSG:  n  = 20) and physical therapy group (PTG', 'personal low-frequency stimulation (PLS) and physical therapy (PT', 'Electrotherapy', 'PLS']","['pain intensity by surface electromyography (sEMG), visual analogue scale (VAS) and a short-form McGill pain questionnaire (SF-MPQ', 'Myalgia', 'pain alleviation', 'myalgia alleviation effects', 'VAS scores', 'tendency of muscle relaxation', 'sEMG', 'waist area']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026836', 'cui_str': 'Muscle relaxation'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",39.0,0.00451148,"Additionally, VAS scores significantly decreased between pre- and post-treatment in both PTG ( p  = 0.0098), and PLSG ( p  = 0.0304) groups, but there was no significance difference between the groups.","[{'ForeName': 'Yong-Soon', 'Initials': 'YS', 'LastName': 'Yoon', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Presbyterian (Jesus) Medical Center, 365, Seowon-ro, Wansan-gu, Jeonju-si 54987, Korea.'}, {'ForeName': 'Myoung-Hwan', 'Initials': 'MH', 'LastName': 'Ko', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Jeonbuk National University Medical School, 567, Baekje-daero, Deokjin-gu, Jeonju-si 54896, Korea.'}, {'ForeName': 'Il-Young', 'Initials': 'IY', 'LastName': 'Cho', 'Affiliation': 'Department of Medical Sciences Convergence Research Center for Medical Sciences, Jeonju University, 303, Cheonjam-ro, Wansan-gu, Jeonju-si 55069, Korea.'}, {'ForeName': 'Cheol-Su', 'Initials': 'CS', 'LastName': 'Kim', 'Affiliation': 'Department of Environmental Medical Biology, Wonju College of Medicine, Yonsei University, Wonju-si 26426, Korea.'}, {'ForeName': 'Johny', 'Initials': 'J', 'LastName': 'Bajgai', 'Affiliation': 'Department of Environmental Medical Biology, Wonju College of Medicine, Yonsei University, Wonju-si 26426, Korea.'}, {'ForeName': 'Hong-Young', 'Initials': 'HY', 'LastName': 'Jang', 'Affiliation': 'Department of Physical Education, Sungkyul University, 53, Seonggyeoldaehak-ro, Manan-gu, Anyang-si 14097, Korea.'}, {'ForeName': 'Ka-Eun', 'Initials': 'KE', 'LastName': 'Kim', 'Affiliation': 'Department of Alternative Medicine, Graduate School of Health and Welfare, Jeonju University, 303, Cheonjam-ro, Wansan-gu, Jeonju-si 55069, Korea.'}, {'ForeName': 'Kyu-Jae', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Department of Environmental Medical Biology, Wonju College of Medicine, Yonsei University, Wonju-si 26426, Korea.'}, {'ForeName': 'Mihyun', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Education, Sungkyul University, 53, Seonggyeoldaehak-ro, Manan-gu, Anyang-si 14097, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph19020735']
1744,35032932,Experiences of pregnant women and healthcare professionals of participating in a digital antenatal CMV education intervention.,"OBJECTIVE


The study aimed to explore the perspectives of participating pregnant women and Health Care Professionals (HCPs) towards receiving and providing cytomegalovirus (CMV) education so that barriers and facilitators towards incorporating CMV in routine antenatal care could be better understood.
DESIGN


This process evaluation phase employed a qualitative design using individual, semi-structured, face-to-face interviews.
SETTING


Recruitment and interviews took place within a large teaching hospital from an ethnically diverse area of South-west London PARTICIPANTS: The study sample included 20 participants: 15 pregnant women, and five HCPs. All participants were involved in a single centre randomized controlled trial of a digital CMV educational intervention in pregnancy.
FINDINGS


Pregnant participants expressed a strong desire to receive information about CMV as part of routine antenatal care. Although HCPs were accepting of the need for CMV education, it was evident that they felt unequipped to provide this; reasons included lack of time, uncertainty about clinical pathways and concern about the potential emotive impact of CMV education. Pregnant women suggested that expressing behaviour changes as risk reduction rather than prevention, made the behaviours feel more achievable and realistic. The support of partners was considered a key factor in the successful adoption of behavioural changes by pregnant women.
KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE


There is an onus on HCPs to consider how CMV can be included as part of antenatal education, with messaging framed as risk reducing rather than prevention.",2022,"Although HCPs were accepting of the need for CMV education, it was evident that they felt unequipped to provide this; reasons included lack of time, uncertainty about clinical pathways and concern about the potential emotive impact of CMV education.","['pregnant women and healthcare professionals of participating in a digital antenatal CMV education intervention', 'Recruitment and interviews took place within a large teaching hospital from an ethnically diverse area of South-west London PARTICIPANTS: The study sample included 20 participants: 15 pregnant women, and five HCPs', 'Pregnant women', 'participating pregnant women and Health Care Professionals (HCPs) towards receiving and providing cytomegalovirus (CMV) education', 'Pregnant participants']",['digital CMV educational intervention'],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],20.0,0.101444,"Although HCPs were accepting of the need for CMV education, it was evident that they felt unequipped to provide this; reasons included lack of time, uncertainty about clinical pathways and concern about the potential emotive impact of CMV education.","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Montague', 'Affiliation': ""Centre for Applied Health and Social Care Research, Faculty of Health, Social Care and Education, Kingston University and St George's, University of London.""}, {'ForeName': 'Tushna', 'Initials': 'T', 'LastName': 'Vandrevala', 'Affiliation': ""Centre for Applied Health and Social Care Research, Faculty of Health, Social Care and Education, Kingston University and St George's, University of London.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Calvert', 'Affiliation': ""Paediatric Infectious Diseases Research Group, St George's, University of London, London, United Kingdom; St George's University Hospitals NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'I-Ling', 'Initials': 'IL', 'LastName': 'Yeh', 'Affiliation': ""Centre for Applied Health and Social Care Research, Faculty of Health, Social Care and Education, Kingston University and St George's, University of London.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Star', 'Affiliation': 'CMV Action, United Kingdom.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Khalil', 'Affiliation': ""Paediatric Infectious Diseases Research Group, St George's, University of London, London, United Kingdom; St George's University Hospitals NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Griffiths', 'Affiliation': 'University College London Medical School, Institute of Immunity and Transplantation, London, United Kingdom.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Heath', 'Affiliation': ""Paediatric Infectious Diseases Research Group, St George's, University of London, London, United Kingdom; St George's University Hospitals NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': ""Paediatric Infectious Diseases Research Group, St George's, University of London, London, United Kingdom; Clinical and Experimental Sciences, Faculty of Medicine and Institute for Life Sciences, University of Southampton and NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Room LF102, F Level, South Academic Block,Tremona Road, Southampton SO16 6YD, United Kingdom. Electronic address: c.e.jones@soton.ac.uk.""}]",Midwifery,['10.1016/j.midw.2022.103249']
1745,35055783,Feasibility of Chest Wall and Diaphragm Proprioceptive Neuromuscular Facilitation (PNF) Techniques in Mechanically Ventilated Patients.,"Physical therapy is part of the treatment for patients admitted to ICU. Proprioceptive neuromuscular facilitation (PNF) is one of the physiotherapy concepts including manual techniques and verbal stimulation. The purpose of this paper is to examine the feasibility of PNF techniques in mechanically ventilated (MV) ICU patients. Another aim is to verify whether the technique using resistance during the patient's inhalation will have a different effect than the technique used to teaching the correct breathing patterns.
METHODS


Patients admitted to tertiary ICU were enrolled in this study, randomly divided into two groups, and received four 90-second manual breathing stimulations each. The following vital signs were assessed: HR, SBP, DBP, and SpO 2 .
RESULTS


61 MV ICU adult patients (mean age 67.8; 25 female and 36 male) were enrolled in this study. No significant differences in HR, SBP, and DBP were observed both for two techniques measured separately and between them. Statistically significant differences were noticed analysing SpO 2  in the rhythmic initiation technique (RIT) group ( p -value = 0.013).
CONCLUSIONS


Short-term PNF interventions did not influence clinically relevant vital parameters among MV patients and seem to be feasible in this group of ICU patients.",2022,"Statistically significant differences were noticed analysing SpO 2  in the rhythmic initiation technique (RIT) group ( p -value = 0.013).
","['mechanically ventilated (MV) ICU patients', '61 MV ICU adult patients (mean age 67.8; 25 female and 36 male', 'Mechanically Ventilated Patients', 'patients admitted to ICU', 'Patients admitted to tertiary ICU']","['Chest Wall and Diaphragm Proprioceptive Neuromuscular Facilitation (PNF) Techniques', 'Proprioceptive neuromuscular facilitation (PNF', 'Physical therapy']","['HR, SBP, DBP, and SpO 2 ', 'HR, SBP, and DBP']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}]","[{'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",61.0,0.0161904,"Statistically significant differences were noticed analysing SpO 2  in the rhythmic initiation technique (RIT) group ( p -value = 0.013).
","[{'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Zwoliński', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, Medical University of Gdańsk, 80-210 Gdansk, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Wujtewicz', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Faculty of Medicine, Medical University of Gdańsk, 80-210 Gdansk, Poland.'}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Szamotulska', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, Medical University of Gdańsk, 80-210 Gdansk, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Sinoracki', 'Affiliation': 'Physiotherapy Department, University Clinical Center, 80-219 Gdansk, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Wąż', 'Affiliation': 'Department of Nuclear Medicine, Faculty of Health Sciences, Medical University of Gdańsk, 80-210 Gdansk, Poland.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Hansdorfer-Korzon', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, Medical University of Gdańsk, 80-210 Gdansk, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Basiński', 'Affiliation': 'Department of Nursing and Medical Rescue, Institute of Health Sciences, Pomeranian University in Słupsk, 76-200 Slupsk, Poland.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Gosselink', 'Affiliation': 'Department Rehabilitation Sciences, Faculty Movement and Rehabilitation Sciences, University Hospitals Leuven, 3000 Leuven, Belgium.'}]",International journal of environmental research and public health,['10.3390/ijerph19020960']
1746,35060868,Effects of Brief Mental Skills Training on Emergency Medicine Residents' Stress Response During a Simulated Resuscitation: A Prospective Randomized Trial.,"BACKGROUND


Acute stress impairs physician decision-making and clinical performance in resuscitations. Mental skills training, a component of the multistep, cognitive-behavioral technique of stress inoculation, modulates stress response in high-performance fields.
OBJECTIVE


We assessed the effects of mental skills training on emergency medicine (EM) residents' stress response in simulated resuscitations as well as residents' perceptions of this intervention.
METHODS


In this prospective, educational intervention trial, postgraduate year-2 EM residents in seven Chicago-area programs were randomly assigned to receive either stress inoculation training or not. One month prior to assessment, the intervention group received didactic training on the ""Breathe, Talk, See, Focus"" mental performance tool. A standardized, case-based simulation was used for assessment. We measured subjective stress response using the six-item short form of the Spielberger State-Trait Anxiety Inventory (STAI-6). Objective stress response was measured through heart rate (HR) and heart rate variability (HRV) monitoring. We measured subjects' perceptions of the training via survey.
RESULTS


Of 92 eligible residents, 61 participated (25 intervention; 36 control). There were no significant differences in mean pre-/post-case STAI-6 scores (-1.7 intervention, 0.4 control; p = 0.38) or mean HRV (-3.8 milliseconds [ms] intervention, -3.8 ms control; p = 0.58). Post-assessment surveys indicated that residents found this training relevant and important.
CONCLUSION


There was no difference in subjective or objective stress measures of EM resident stress response after a didactic, mental performance training session, although residents did value the training. More extensive or longitudinal stress inoculation curricula may provide benefit.",2022,"There was no difference in subjective or objective stress measures of EM resident stress response after a didactic, mental performance training session, although residents did value the training.","['postgraduate year-2 EM residents in seven Chicago-area programs', ""Emergency Medicine Residents' Stress Response During a Simulated Resuscitation"", 'Of 92 eligible residents, 61 participated (25 intervention; 36 control']","['Mental skills training, a component of the multistep, cognitive-behavioral technique of stress inoculation', 'didactic training', 'Brief Mental Skills Training', 'stress inoculation training or not', 'mental skills training']","['Objective stress response', 'mean pre-/post-case STAI-6 scores', 'mean HRV', 'heart rate (HR) and heart rate variability (HRV) monitoring', 'subjective stress response', 'subjective or objective stress measures of EM resident stress response']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",92.0,0.00197978,"There was no difference in subjective or objective stress measures of EM resident stress response after a didactic, mental performance training session, although residents did value the training.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Aronson', 'Affiliation': 'Advocate Christ Medical Center, Department of Emergency Medicine, Oak Lawn, Illinois.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Henderson', 'Affiliation': 'Advocate Christ Medical Center, Department of Emergency Medicine, Oak Lawn, Illinois.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Dodd', 'Affiliation': 'Advocate Christ Medical Center, Department of Emergency Medicine, Oak Lawn, Illinois.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cirone', 'Affiliation': 'Advocate Christ Medical Center, Department of Emergency Medicine, Oak Lawn, Illinois.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Putman', 'Affiliation': 'Advocate Christ Medical Center, Department of Emergency Medicine, Oak Lawn, Illinois.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Salzman', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Department of Emergency Medicine and Department of Medical Education, Chicago, Illinois.'}, {'ForeName': 'Elise O', 'Initials': 'EO', 'LastName': 'Lovell', 'Affiliation': 'Advocate Christ Medical Center, Department of Emergency Medicine, Oak Lawn, Illinois.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Williamson', 'Affiliation': 'Advocate Christ Medical Center, Department of Emergency Medicine, Oak Lawn, Illinois.'}]",The western journal of emergency medicine,['10.5811/westjem.2021.10.53892']
1747,35060855,"Learning Outcomes of High-fidelity versus Table-Top Simulation in Undergraduate Emergency Medicine Education: Prospective, Randomized, Crossover-Controlled Study.","INTRODUCTION


Over the last several decades simulation, in both graduate and undergraduate emergency medicine education, has continued to develop as a leading and highly effective teaching modality. Limited research exists to evaluate the efficacy of low-fidelity (table-top) simulation, as compared to high-fidelity standards, as it relates to medical knowledge learning outcomes. We sought to assess the efficacy of a low-fidelity simulation modality in undergraduate emergency medicine education, based on quantitative medical knowledge learning outcomes.
METHODS


A prospective, randomized, crossover-control study comparing objective medical knowledge learning outcomes between simulation modalities. Analysis was designed to evaluate for the statistical equivalence of learning outcomes between the two cohorts. This was done by comparing a calculated 95% confidence interval (CI) around the mean difference in post-test scores, between experimental and control modalities, to a pre-established equivalence margin.
RESULTS


Primary outcomes evaluating student performance on post-test examinations demonstrated a total cohort CI (95% CI, -0.22 and 0.68). Additional course-subject subgroup analysis demonstrated non-inferior CIs with: Shortness of Breath (95% CI, -0.35 and 1.27); Chest Pain (95% CI, -0.53 and.94); Abdominal Pain (95% CI, -0.88 and 1.17); Cardiovascular Shock (95% CI, -0.04 and 1.29). Secondary outcome analysis was done to evaluate medical knowledge acquisition by comparing the difference in pre and post-test examination between the cohorts. CI of the full cohort ranged from (95% CI, -0.14 and 0.96).
CONCLUSION


The student's performance on quantitative medical-knowledge assessment was equivalent between the high-fidelity control and low-fidelity experimental simulation groups. Analysis of knowledge acquisition between the two groups also demonstrated statistical equivalence.",2022,The student's performance on quantitative medical-knowledge assessment was equivalent between the high-fidelity control and low-fidelity experimental simulation groups.,"['undergraduate emergency medicine education', 'Undergraduate Emergency Medicine Education']","['High-fidelity versus Table-Top Simulation', 'low-fidelity simulation modality']","['student performance on post-test examinations demonstrated a total cohort CI', 'Cardiovascular Shock', 'Abdominal Pain', 'medical knowledge acquisition', 'Shortness of Breath', 'Chest Pain']","[{'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}]",,0.162507,The student's performance on quantitative medical-knowledge assessment was equivalent between the high-fidelity control and low-fidelity experimental simulation groups.,"[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Offenbacher', 'Affiliation': 'Albert Einstein College of Medicine, Department of Emergency Medicine at the Jacobi and Montefiore Hospitals, Bronx, New York.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Petti', 'Affiliation': 'Albert Einstein College of Medicine, Department of Emergency Medicine at the Jacobi and Montefiore Hospitals, Bronx, New York.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Albert Einstein College of Medicine, Department of Emergency Medicine at the Jacobi and Montefiore Hospitals, Bronx, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Levine', 'Affiliation': 'Albert Einstein College of Medicine, Department of Emergency Medicine at the Jacobi and Montefiore Hospitals, Bronx, New York.'}, {'ForeName': 'Mallika', 'Initials': 'M', 'LastName': 'Manyapu', 'Affiliation': 'Albert Einstein College of Medicine, Department of Emergency Medicine at the Jacobi and Montefiore Hospitals, Bronx, New York.'}, {'ForeName': 'Debayan', 'Initials': 'D', 'LastName': 'Guha', 'Affiliation': 'Albert Einstein College of Medicine, Department of Emergency Medicine at the Jacobi and Montefiore Hospitals, Bronx, New York.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Quint', 'Affiliation': 'Albert Einstein College of Medicine, Department of Emergency Medicine at the Jacobi and Montefiore Hospitals, Bronx, New York.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chertoff', 'Affiliation': 'Albert Einstein College of Medicine, Department of Emergency Medicine at the Jacobi and Montefiore Hospitals, Bronx, New York.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Restivo', 'Affiliation': 'Albert Einstein College of Medicine, Department of Emergency Medicine at the Jacobi and Montefiore Hospitals, Bronx, New York.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Friedman', 'Affiliation': 'Albert Einstein College of Medicine, Department of Emergency Medicine at the Jacobi and Montefiore Hospitals, Bronx, New York.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Silverberg', 'Affiliation': 'Albert Einstein College of Medicine, Department of Emergency Medicine at the Jacobi and Montefiore Hospitals, Bronx, New York.'}]",The western journal of emergency medicine,['10.5811/westjem.2021.12.53926']
1748,35060853,A Virtual Escape Room versus Lecture on Infectious Disease Content: Effect on Resident Knowledge and Motivation.,"INTRODUCTION


Medical educators are constantly seeking methods to increase engagement in the era of coronavirus disease 2019 (COVID-19) where virtual and blended learning formats are increasingly common. Educational escape rooms have previously been used to motivate learners, enhance communication skills, and cultivate teamwork. However, it is not known whether escape rooms increase learner knowledge as compared to a lecture format.
METHODS


This quasi-experimental study included 30 emergency medicine residents at two programs who participated in both a virtual escape room and a lecture on infectious disease content. Learners completed a pre- and post-quiz and a tool to gauge resident motivation for each activity (the Intrinsic Motivation Inventory [IMI]). The primary objective was to determine a change in knowledge as a result of the activities, and a secondary objective was to determine resident motivation for each format.
RESULTS


At both programs learners demonstrated a significant improvement in their pre- vs. post-quiz scores for the escape rooms (University of California Irvine [UCI]: 77.8% to 88.9%, p = 0.028, Prisma: 73.81% to 89.68%, p = 0.002), whereas the lectures did not impact a statistical improvement (UCI: 73.8% to 78.6%, p = 0.460, Prisma: 85.71% to 91.27%, p = 0.236). Learners at UCI noted equivalent results on the IMI for both formats, while residents at Prisma noted they were more motivated by the escape room.
CONCLUSION


Emergency medicine residents at two programs participating in a virtual escape room demonstrated a statistical increase in knowledge on infectious disease content as compared to a lecture format and reported positive motivation ratings for both formats, with one program preferring the escape room.",2022,"At both programs learners demonstrated a significant improvement in their pre- vs. post-quiz scores for the escape rooms (University of California Irvine [UCI]: 77.8% to 88.9%, p = 0.028, Prisma: 73.81% to 89.68%, p = 0.002), whereas the lectures did not impact a statistical improvement (UCI: 73.8% to 78.6%, p = 0.460, Prisma: 85.71% to 91.27%, p = 0.236).",['30 emergency medicine residents at two programs who participated in both a virtual escape room and a lecture on infectious disease content'],[],"['positive motivation ratings', 'pre- vs. post-quiz scores']","[{'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0433008,"At both programs learners demonstrated a significant improvement in their pre- vs. post-quiz scores for the escape rooms (University of California Irvine [UCI]: 77.8% to 88.9%, p = 0.028, Prisma: 73.81% to 89.68%, p = 0.002), whereas the lectures did not impact a statistical improvement (UCI: 73.8% to 78.6%, p = 0.460, Prisma: 85.71% to 91.27%, p = 0.236).","[{'ForeName': 'Sara P', 'Initials': 'SP', 'LastName': 'Dimeo', 'Affiliation': 'University of South Carolina, Greenville School of Medicine, Department of Emergency Medicine, Greenville, South Carolina.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Astemborksi', 'Affiliation': 'Prisma Health Upstate, Department of Emergency Medicine, Greenville, South Carolina.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Smart', 'Affiliation': 'University of California, Irvine School of Medicine, Department of Emergency Medicine, Orange, California.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Jones', 'Affiliation': 'Johns Hopkins School of Education, Masters of Education for Healthcare Professionals Program, Baltimore, Maryland.'}]",The western journal of emergency medicine,['10.5811/westjem.2021.12.54010']
1749,35081022,High-Dose Convalescent Plasma for Treatment of Severe COVID-19.,"To assess whether high-dose coronavirus disease (COVID-19) convalescent plasma (CCP) transfusion may benefit patients with severe COVID-19, we conducted a multicenter randomized trial in Brazil. Patients with severe COVID-19 who were within 10 days of initial symptom onset were eligible. Patients in the CCP group received 3 daily doses of CCP (600 mL/d) in addition to standard treatment; control patients received standard treatment only. Primary outcomes were death rates at days 30 and 60 of study randomization. Secondary outcomes were ventilator-free days and hospital-free days. We enrolled 107 patients: 36 CCP and 71 control. At day 30, death rates were 22% for CCP and 25% for the control group; at day 60, rates were 31% for CCP and 35% for control. Needs for invasive mechanical ventilation and durations of hospital stay were similar between groups. We conclude that high-dose CCP transfused within 10 days of symptom onset provided no benefit for patients with severe COVID-19.",2022,"At day 30, death rates were 22% for CCP and 25% for the control group; at day 60, rates were 31% for CCP and 35% for control.","['We enrolled 107 patients: 36 CCP and 71 control', 'Patients with severe COVID-19 who were within 10 days of initial symptom onset were eligible', 'patients with severe COVID-19']","['high-dose coronavirus disease (COVID-19) convalescent plasma (CCP) transfusion', 'CCP']","['death rates', 'ventilator-free days and hospital-free days', 'invasive mechanical ventilation and durations of hospital stay']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",107.0,0.157151,"At day 30, death rates were 22% for CCP and 25% for the control group; at day 60, rates were 31% for CCP and 35% for control.","[{'ForeName': 'Gil C', 'Initials': 'GC', 'LastName': 'De Santis', 'Affiliation': ''}, {'ForeName': 'Luciana Correa', 'Initials': 'LC', 'LastName': 'Oliveira', 'Affiliation': ''}, {'ForeName': 'Pedro M M', 'Initials': 'PMM', 'LastName': 'Garibaldi', 'Affiliation': ''}, {'ForeName': 'Carlos E L', 'Initials': 'CEL', 'LastName': 'Almado', 'Affiliation': ''}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Croda', 'Affiliation': ''}, {'ForeName': 'Ghislaine G A', 'Initials': 'GGA', 'LastName': 'Arcanjo', 'Affiliation': ''}, {'ForeName': 'Érika A F', 'Initials': 'ÉAF', 'LastName': 'Oliveira', 'Affiliation': ''}, {'ForeName': 'Adriana C', 'Initials': 'AC', 'LastName': 'Tonacio', 'Affiliation': ''}, {'ForeName': 'Dante M', 'Initials': 'DM', 'LastName': 'Langhi', 'Affiliation': ''}, {'ForeName': 'José O', 'Initials': 'JO', 'LastName': 'Bordin', 'Affiliation': ''}, {'ForeName': 'Renato N', 'Initials': 'RN', 'LastName': 'Gilio', 'Affiliation': ''}, {'ForeName': 'Leonardo C', 'Initials': 'LC', 'LastName': 'Palma', 'Affiliation': ''}, {'ForeName': 'Elaine V', 'Initials': 'EV', 'LastName': 'Santos', 'Affiliation': ''}, {'ForeName': 'Simone K', 'Initials': 'SK', 'LastName': 'Haddad', 'Affiliation': ''}, {'ForeName': 'Benedito P A', 'Initials': 'BPA', 'LastName': 'Prado', 'Affiliation': ''}, {'ForeName': 'Marjorie Cornejo', 'Initials': 'MC', 'LastName': 'Pontelli', 'Affiliation': ''}, {'ForeName': 'Rogério', 'Initials': 'R', 'LastName': 'Gomes', 'Affiliation': ''}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Miranda', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Auxiliadora Martins', 'Affiliation': ''}, {'ForeName': 'Dimas T', 'Initials': 'DT', 'LastName': 'Covas', 'Affiliation': ''}, {'ForeName': 'Eurico', 'Initials': 'E', 'LastName': 'Arruda', 'Affiliation': ''}, {'ForeName': 'Benedito A L', 'Initials': 'BAL', 'LastName': 'Fonseca', 'Affiliation': ''}, {'ForeName': 'Rodrigo T', 'Initials': 'RT', 'LastName': 'Calado', 'Affiliation': ''}]",Emerging infectious diseases,['10.3201/eid2803.212299']
1750,35086737,"Corrigendum to ""International Tailored Chemotherapy Adjuvant (ITACA) trial, a phase III multicenter randomized trial comparing adjuvant pharmacogenomic-driven chemotherapy versus standard adjuvant chemotherapy in completely resected stage II-IIIA non-small-cell lung cancer"": [Annals of Oncology 33 (2022) 57-66].",,2022,,[],['adjuvant pharmacogenomic-driven chemotherapy versus standard adjuvant chemotherapy'],[],[],"[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1138555', 'cui_str': 'Pharmacogenomic specialist'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]",[],,0.43013,,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'University of Torino, Department of Oncology at San Luigi Hospital, Orbassano (Torino), Italy. Electronic address: silvia.novello@unito.it.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Oncology Department at Instituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Grohe', 'Affiliation': 'Department of Respiratory Diseases, Evangelische Lungenklinik Berlin, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kurz', 'Affiliation': 'Evangelische Lungenklinik Berlin, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Serke', 'Affiliation': 'Thorax Center Clinic for Haematology, Oncology, Pulmonology and Palliative Medicine, Evangelisches Krankenhaus Hamm, Hamm, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wehler', 'Affiliation': 'Thorax Center Clinic for Haematology, Oncology, Pulmonology and Palliative Medicine, Evangelisches Krankenhaus Hamm, Hamm, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'Department of Pneumology, Maria Hilf Hospital, Moenchengladbach, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ladage', 'Affiliation': 'Department of Pneumology, Maria Hilf Hospital, Moenchengladbach, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Geissler', 'Affiliation': 'Esslingen Cancer Center Department of Oncology, Gastroenterology and Infectious Diseases Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Colantonio', 'Affiliation': 'Division of Oncology, Azienda Ospedaliera Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cauchi', 'Affiliation': 'Division of Oncology, Azienda Ospedaliera Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stoelben', 'Affiliation': 'Lung Clinic, Cologne-Merheim Hospital, Cologne, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ceribelli', 'Affiliation': 'Division of Clinical Oncology A, Istituto Nazionale Regina Elena per lo Studio e la Cura dei Tumori, Rome, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kropf-Sanchen', 'Affiliation': 'Department of Pulmonology, Internal Medicine II, University of Ulm, Ulm, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Valmadre', 'Affiliation': 'Division of Clinical Oncology, Ospedale di Sondalo, Sondrio, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Borra', 'Affiliation': 'Division of Clinical Oncology, AOU Maggiore della Carità, Novara, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schena', 'Affiliation': 'Division of Clinical Oncology I, AOU Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morabito', 'Affiliation': 'Division of Clinical Oncology and Thoracic Pneumology, IRCCS Fondazione Pascale, Naples, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Santo', 'Affiliation': 'Complex Operative Unit of Oncology - Gruppo Interdisciplinare Veronese Oncologia Polmonare (GIVOP), Verona, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gregorc', 'Affiliation': 'Division of Clinical Oncology, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chiari', 'Affiliation': 'Division of Clinical Oncology, Azienda Ospedaliera di Perugia, Ospedale Santa Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Oncology Department, LungenClinic Grosshansdorf, Grosshansdorf, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schmid-Bindert', 'Affiliation': 'Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Folprecht', 'Affiliation': 'University Hospital Carl Gustav Carus Medical Department I Dresden, Dresden, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Griesinger', 'Affiliation': 'Clinic for Haematology and Oncoloy, Medizinischer Campus Universität Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Follador', 'Affiliation': 'Department of Oncology, Presidio Ospedaliero Universitario Santa Maria della Misericordia, Azienda Sanitaria Universitaria Integrata Friuli Centrale, Udine, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pedrazzoli', 'Affiliation': 'Medical Oncology, Fondazione IRCCS Policlinico S. Matteo and Department of Internal Medicine and Medical Therapy, University of Pavia, Pavia, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bearz', 'Affiliation': 'Division of Clinical Oncology, Centro di Riferimento Oncologico, Aviano, Italy.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Caffo', 'Affiliation': 'Division of Clinical Oncology, Ospedale Santa Chiara, Trento, Italy.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Dickgreber', 'Affiliation': 'Department for Respiratory Medicine and Thoracic Oncology, Klinikum Rheine - Mathias-Spital, Rheine, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Irtelli', 'Affiliation': 'Oncology Clinic, Policlinico SS. Annunziata, Chieti, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wiest', 'Affiliation': 'Asklepios Cancer Center Hamburg, Asklepios Klinikum Harburg, Hamburg, Harburg, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Monica', 'Affiliation': 'University of Torino, Department of Oncology at San Luigi Hospital, Orbassano (Torino), Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Porcu', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Oncology Department at Instituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Manegold', 'Affiliation': 'Department of Surgery, University Medical Center Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Scagliotti', 'Affiliation': 'University of Torino, Department of Oncology at San Luigi Hospital, Orbassano (Torino), Italy.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2022.01.005']
1751,35057807,Association between exercise frequency with renal and cardiovascular outcomes in diabetic and non-diabetic individuals at high cardiovascular risk.,"BACKGROUND


Guidelines recommend physical activity to reduce cardiovascular (CV) events. The association between physical activity and progression of chronic kidney disease (CKD) with and without diabetes is unknown. We assessed the association of self-reported physical activity with renal and CV outcomes in high-risk patients aged ≥ 55 years over a median follow-up of 56 months in post-hoc analysis of a previously randomized trial program.
METHODS


Analyses were done with Cox regression analysis, mixed models for repeated measures, ANOVA and χ 2 -test. 31,312 patients, among them 19,664 with and 11,648 without diabetes were analyzed.
RESULTS


Physical activity was inversely associated with renal outcomes (doubling of creatinine, end-stage kidney disease (ESRD)) and CV outcomes (CV death, myocardial infarction, stroke, heart failure hospitalization). Moderate activity (at least 2 times/week to every day) was associated with lower risk of renal outcomes and lower incidence of new albuminuria (p < 0.0001 for both) compared to lower exercise levels. Similar results were observed for those with and without diabetes without interaction for renal outcomes (p = 0.097-0.27). Physical activity was associated with reduced eGFR decline with a moderate association between activity and diabetes status (p = 0.05).
CONCLUSIONS


Moderate physical activity was associated with improved kidney outcomes with a threshold at two sessions per week. The association of physical activity with renal outcomes did not meaningfully differ with or without diabetes but absolute benefit of activity was even greater in people with diabetes. Thus, risks were similar between those with diabetes undertaking high physical activity and those without diabetes but low physical activity.
CLINICAL TRIAL REGISTRATION


http://clinicaltrials.gov.uniqueidentifier :NCT00153101.",2022,"Physical activity was associated with reduced eGFR decline with a moderate association between activity and diabetes status (p = 0.05).
","['high-risk patients aged\u2009≥', 'people with diabetes', 'diabetic and non-diabetic individuals at high cardiovascular risk', '31,312 patients, among them 19,664 with and 11,648 without diabetes were analyzed']",[],"['lower risk of renal outcomes and lower incidence of new albuminuria', 'Physical activity', 'kidney outcomes', 'Moderate activity', 'renal outcomes', 'renal outcomes (doubling of creatinine, end-stage kidney disease (ESRD)) and CV outcomes (CV death, myocardial infarction, stroke, heart failure hospitalization']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332288', 'cui_str': 'Without'}]",[],"[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",31312.0,0.0595476,"Physical activity was associated with reduced eGFR decline with a moderate association between activity and diabetes status (p = 0.05).
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Saarland University, Kirrberger Str. 1, 66421, Homburg/Saar, Germany. michael.boehm@uks.eu.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schumacher', 'Affiliation': 'Statistical Consultant, 55218, Ingelheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Werner', 'Affiliation': 'Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Saarland University, Kirrberger Str. 1, 66421, Homburg/Saar, Germany.'}, {'ForeName': 'Koon K', 'Initials': 'KK', 'LastName': 'Teo', 'Affiliation': 'Department of Medicine, Population Health Research Institute, McMaster University, Hamilton, ON, L8L 2X2, Canada.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Lonn', 'Affiliation': 'Department of Medicine, Population Health Research Institute, McMaster University, Hamilton, ON, L8L 2X2, Canada.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mahfoud', 'Affiliation': 'Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Saarland University, Kirrberger Str. 1, 66421, Homburg/Saar, Germany.'}, {'ForeName': 'Thimoteus', 'Initials': 'T', 'LastName': 'Speer', 'Affiliation': 'Klinik für Innere Medizin IV, Universitätsklinikum des Saarlandes, Saarland University, Kirrberger Str.1, Homburg/Saar, Germany.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': ""University of Milano-Bicocca, Istituto Clinico Universitario Policlinico di Monza, Piazza dell'Ateneo Nuovo, 1, Milan, Italy.""}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Redon', 'Affiliation': 'Hypertension Unit, Hospital CIínico Universitario, University of Valencia, Av. de Blasco Ibáñez, 13, València, Spain.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Schmieder', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital, Friedrich-Alexander University, Erlangen/Nuremberg, Germany.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sliwa', 'Affiliation': 'Faculty of Health Sciences, Hatter Institute for Cardiovascular Research in Africa & IIDMM, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Department of Internal Medicine, University Hospital RWTH Aachen, Pauwelsstraße 30, Aachen, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Weber', 'Affiliation': 'Downstate College of Medicine, State University of New York, 450 Clarkson Ave, Brooklyn, NY, USA.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'University College London (UCL), Institute of Cardiovascular Science, National Institute for Health Research (NIHR), UCL Hospitals Biomedical Research Centre, 149 Tottenham Court Road, London, UK.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Department of Medicine, Population Health Research Institute, McMaster University, Hamilton, ON, L8L 2X2, Canada.'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Centre, München-Schwabing, Minich, Germany.'}]",Cardiovascular diabetology,['10.1186/s12933-021-01429-w']
1752,35060543,"The effect of lung-conduction exercise in chronic obstructive pulmonary disease: Randomized, assessor-blind, multicenter pilot trial.","BACKGROUND


Pulmonary rehabilitation (PR) is a management modality that improves the quality of life of patients with chronic obstructive pulmonary disease (COPD); however, PR is not readily accessible. Therefore, we developed lung-conduction exercises (LCE) that can be performed easily without any limitations. The purpose of this randomized, assessor-blind, multicenter pilot trial was to compare the effects of LCE with PR and standard care (SC) in COPD patients.
METHODS


Twenty-five participants who met the eligibility criteria were randomly allocated to the SC group (only medication, n = 9), LCE group (medication + LCE, 5 times a week, n = 8), or PR group (medication + PR, 5 times a week, n = 8). The 6-minute walk distance (6WMD), pulmonary function test, modified Medical Research Council dyspnea scale, COPD assessment test (CAT), and St. George Respiratory Questionnaire (SGRQ) survey were carried out before starting the trial and after 4 and 8 weeks to determine motor performance, lung function, and dyspnea.
RESULTS


After 8 weeks, the pulmonary function test scores were the same. The 6MWD (PR, 28.3 ± 38.5; LCE, 14.5 ± 53.1; SC, 11.5 ± 20.5; P = .984), modified Medical Research Council dyspnea scale (PR, 0.8 ± 1.0; LCE, 0.8 ± 0.8; SC, 0.3 ± 0.5; P = .772), CAT (PR, 7.3 ± 6.2; LCE, 4.2 ± 5.2; SC, 1.0 ± 2.2; P = .232), and SGRQ scores (PR, 11.5 ± 15.4; LCE, 5.5 ± 13.1; SC, 4.8 ± 5.1; P = .358 [PR vs LCE], P = .795 [PR vs SC]) had improved in order of PR, LCE, and SC group. Although there were no statistically significant differences in the outcome measures between the groups, there were clinically significant improvements in the CAT and SGRQ scores.
CONCLUSIONS


In this trial, PR showed more improvement in symptoms and quality of life than SC alone. To seek a more precise use of LCE, further full-sized studies with a long duration and additional outcome measures such as psychological assessment tools and cost-effectiveness ratio should be conducted.
TRIAL REGISTRATION


KCT0004724.",2022,"Although there were no statistically significant differences in the outcome measures between the groups, there were clinically significant improvements in the CAT and SGRQ scores.
","['COPD patients', 'Twenty-five participants who met the eligibility criteria', 'patients with chronic obstructive pulmonary disease (COPD', 'chronic obstructive pulmonary disease']","['SC', 'LCE group (medication + LCE', 'PR vs LCE', 'LCE with PR and standard care (SC', 'lung-conduction exercise', 'Pulmonary rehabilitation (PR', 'lung-conduction exercises (LCE']","['pulmonary function test scores', 'symptoms and quality of life', 'modified Medical Research Council dyspnea scale', 'motor performance, lung function, and dyspnea', 'SGRQ scores', '6-minute walk distance (6WMD), pulmonary function test, modified Medical Research Council dyspnea scale, COPD assessment test (CAT), and St. George Respiratory Questionnaire (SGRQ) survey', 'quality of life', 'CAT and SGRQ scores']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",25.0,0.0628611,"Although there were no statistically significant differences in the outcome measures between the groups, there were clinically significant improvements in the CAT and SGRQ scores.
","[{'ForeName': 'Su Won', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.'}, {'ForeName': 'Jae Jun', 'Initials': 'JJ', 'LastName': 'Park', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.'}, {'ForeName': 'Yee Ran', 'Initials': 'YR', 'LastName': 'Lyu', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.'}, {'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.'}, {'ForeName': 'Si Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University, Daejeon, Republic of Korea.'}, {'ForeName': 'Weechang', 'Initials': 'W', 'LastName': 'Kang', 'Affiliation': 'Department of Statistics, Hyehwa Liberal Arts College, Daejeon University, Daejeon, Republic of Korea.'}, {'ForeName': 'Ji Woong', 'Initials': 'JW', 'LastName': 'Son', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Konyang University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'In Chul', 'Initials': 'IC', 'LastName': 'Jung', 'Affiliation': 'Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University, Daejeon, Republic of Korea.'}, {'ForeName': 'Yang Chun', 'Initials': 'YC', 'LastName': 'Park', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000028629']
1753,35060542,"Effects of individualized administration of folic acid on prothrombotic state and vascular endothelial function with H-type hypertension: A double-blinded, randomized clinical cohort study.","BACKGROUND


Hypertension and hyperhomocysteinemia (HHcy) have long been associated with adverse cardiovascular and cerebrovascular health outcomes. This study evaluated the effect of individualized administration of folic acid (FA) on homocysteine (Hcy) levels, prothrombotic state, and blood pressure (BP) in patients with H-type hypertension (combination of HHcy and hypertension).
METHODS


In this double-blinded, randomized clinical cohort study, 126 patients with H-type hypertension who were treated at our hospital were randomly divided into treatment and control groups (n = 55 each). The control group was treated with oral levamlodipine besylate tablets 2.5 mg and placebo, once a day (in the morning). The treatment group was first treated with oral levamlodipine besylate 2.5 mg and FA tablets 0.8 mg, once a day (in the morning), for 12 weeks. Then, in a second 12-week phase, the FA dose was adjusted using the methylene tetrahydrofolate reductase C677 polymorphism genotype. The levels of Hcy and coagulation factors, prothrombotic state parameters, BP, and adverse drug reactions were compared between the 2 groups.
RESULTS


Pretreatment general patient characteristics, including Hcy levels, were similar between the 2 groups (P > .05). BP and prothrombotic status did not differ before and after the first phase of treatment (P > .05). However, Hcy and endothelin-1 (ET-1) levels decreased, while nitric oxide levels increased significantly in the intervention group (P < .05). In the second phase, after 3 months' treatment with an FA dose adjusted according to methylene tetrahydrofolate reductase C677T genotype, the Hcy and ET-1/NO levels were significantly decreased in the intervention group and were lower than those after the first treatment phase and lower than in the control group (P < .01). BP, D-dimer levels, and fibrinogen scores were significantly lower after the second treatment phase (P < .01). There was no significant difference in the incidence of adverse drug reactions between the 2 groups (P > .05).
CONCLUSIONS


Individualized administration of FA tablets can effectively reduce BP, and Hcy and coagulation factor levels, and significantly improve prothrombotic status in patients with H-type hypertension.",2022,"BP, D-dimer levels, and fibrinogen scores were significantly lower after the second treatment phase (P < .01).","['patients with H-type hypertension (combination of HHcy and hypertension', '126 patients with H-type hypertension who were treated at our hospital', 'patients with H-type hypertension']","['oral levamlodipine besylate 2.5\u200amg and FA tablets', 'folic acid (FA', 'folic acid', 'oral levamlodipine besylate tablets 2.5\u200amg and placebo']","['nitric oxide levels', 'BP, and Hcy and coagulation factor levels', 'Hcy levels', 'Hcy and endothelin-1 (ET-1) levels', 'prothrombotic status', 'BP, D-dimer levels, and fibrinogen scores', 'Hcy and ET-1/NO levels', 'levels of Hcy and coagulation factors, prothrombotic state parameters, BP, and adverse drug reactions', 'homocysteine (Hcy) levels, prothrombotic state, and blood pressure (BP', 'incidence of adverse drug reactions', 'BP and prothrombotic status', 'prothrombotic state and vascular endothelial function with H-type hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0598608', 'cui_str': 'Hyperhomocysteinemia'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2717539', 'cui_str': 'levamlodipine'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1703213', 'cui_str': 'Folic Acid Oral Tablet'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0005789', 'cui_str': 'Blood clotting factor'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079284', 'cui_str': 'Endothelin'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",126.0,0.0324026,"BP, D-dimer levels, and fibrinogen scores were significantly lower after the second treatment phase (P < .01).","[{'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""The First People's Hospital of Guangyuan, Sichuan, China.""}, {'ForeName': 'Tianxun', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Huaiqi', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Ailin', 'Initials': 'A', 'LastName': 'Hou', 'Affiliation': ''}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Baozhong', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Shuangming', 'Initials': 'S', 'LastName': 'Ran', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Ruohan', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000028628']
1754,35089371,[Management of severe nut allergy in adults].,"We present a case of walnut allergy in a 24-year-old man. The allergy work up revealed sensitization to walnut including a positive skin prick test and a high value of walnut-specific IgEs. The patient showed an anaphylactic reaction during the double blind placebo-controlled food challenge, to a cumulative dose of 3.723 g of walnut protein. The oral food challenge resulted in counseling regarding strict walnut avoidance and optimization of the emergency management. At follow-up the patient reported that having adhered to the recommended dietary measures resulted in no further allergic reactions.",2022,The allergy work up revealed sensitization to walnut including a positive skin prick test and a high value of walnut-specific IgEs.,"['case of walnut allergy in a\xa024-year-old man', 'severe nut allergy in adults']",[],"['allergic reactions', 'anaphylactic reaction']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0330971', 'cui_str': 'Juglans'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0577620', 'cui_str': 'Allergy to nut'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}]",,0.102617,The allergy work up revealed sensitization to walnut including a positive skin prick test and a high value of walnut-specific IgEs.,"[{'ForeName': 'Aikaterina', 'Initials': 'A', 'LastName': 'Alexiou', 'Affiliation': 'Allergologie und Immunologie, Klinik für Dermatologie, Venerologie und Allergologie, Charité\xa0- Universitätsmedizin Berlin, Luisenstr. 2-5/Charitéplatz\xa01, 10117, Berlin, Deutschland. aikaterina.alexiou@charite.de.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Höfer', 'Affiliation': 'Allergologie und Immunologie, Klinik für Dermatologie, Venerologie und Allergologie, Charité\xa0- Universitätsmedizin Berlin, Luisenstr. 2-5/Charitéplatz\xa01, 10117, Berlin, Deutschland.'}, {'ForeName': 'Josefine', 'Initials': 'J', 'LastName': 'Grünhagen', 'Affiliation': 'Allergologie und Immunologie, Klinik für Dermatologie, Venerologie und Allergologie, Charité\xa0- Universitätsmedizin Berlin, Luisenstr. 2-5/Charitéplatz\xa01, 10117, Berlin, Deutschland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Dölle-Bierke', 'Affiliation': 'Allergologie und Immunologie, Klinik für Dermatologie, Venerologie und Allergologie, Charité\xa0- Universitätsmedizin Berlin, Luisenstr. 2-5/Charitéplatz\xa01, 10117, Berlin, Deutschland.'}, {'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Worm', 'Affiliation': 'Allergologie und Immunologie, Klinik für Dermatologie, Venerologie und Allergologie, Charité\xa0- Universitätsmedizin Berlin, Luisenstr. 2-5/Charitéplatz\xa01, 10117, Berlin, Deutschland.'}]","Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete",['10.1007/s00105-022-04951-4']
1755,35085506,"Pyrotinib plus capecitabine for patients with human epidermal growth factor receptor 2-positive breast cancer and brain metastases (PERMEATE): a multicentre, single-arm, two-cohort, phase 2 trial.","BACKGROUND


Patients with HER2-positive metastatic breast cancer have a high risk of developing brain metastases. Efficacious treatment options are scarce. We investigated the activity and safety of pyrotinib plus capecitabine in patients with HER2-positive metastatic breast cancer and brain metastases.
METHODS


We did a multicentre, single-arm, two-cohort, phase 2 trial in eight tertiary hospitals in China. Patients aged 18 years or older who had radiotherapy-naive HER2-positive brain metastases (cohort A) or progressive disease after radiotherapy (cohort B), with an Eastern Cooperative Oncology Group performance status of 0-2, received pyrotinib 400 mg orally once daily, and capecitabine 1000 mg/m 2  orally twice daily for 14 days, followed by 7 days off every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was confirmed intracranial objective response rate by investigator assessment according to the Response Evaluation Criteria In Solid Tumours (version 1.1). Activity and safety were analysed in patients with at least one dose of study drug. The study is ongoing, but recruitment is complete. The study is registered with ClinicalTrials.gov, NCT03691051.
FINDINGS


Between Jan 29, 2019, and July 10, 2020, we enrolled 78 women: 51 (86%) of 59 patients in cohort A and 18 (95%) of 19 patients in cohort B had previous exposure to trastuzumab. Median follow-up duration was 15·7 months (IQR 9·7-19·0). The intracranial objective response rate was 74·6% (95% CI 61·6-85·0; 44 of 59 patients) in cohort A and 42·1% (20·3-66·5; eight of 19 patients) in cohort B. The most common grade 3 or worse treatment-emergent adverse event was diarrhoea (14 [24%] in cohort A and four [21%] in cohort B). Two (3%) patients in cohort A and three (16%) in cohort B had treatment-related serious adverse events. No treatment-related deaths occurred.
INTERPRETATION


To our knowledge, this is the first prospective study showing the activity and safety of pyrotinib plus capecitabine in patients with HER2-positive breast cancer and brain metastases, especially in radiotherapy-naive population. This combination deserves further validation in a randomised, controlled trial.
FUNDING


National Cancer Centre Climbing Foundation Key Project of China, Jiangsu Hengrui Pharmaceuticals.
TRANSLATION


For the Chinese translation of the abstract see Supplementary Materials section.",2022,The intracranial objective response rate was 74·6% (95% CI 61·6-85·0; 44 of 59 patients) in cohort A and 42·1% (20·3-66·5; eight of 19 patients) in cohort,"['Patients with HER2-positive metastatic breast cancer', 'Between Jan 29, 2019, and July 10, 2020', 'patients with HER2-positive breast cancer and brain metastases, especially in radiotherapy-naive population', 'patients with HER2-positive metastatic breast cancer and brain metastases', 'enrolled 78 women: 51 (86%) of 59 patients in cohort A and 18 (95%) of 19 patients in cohort B had previous exposure to', 'patients with human epidermal growth factor receptor 2-positive breast cancer and brain metastases (PERMEATE', 'Patients aged 18 years or older who had radiotherapy-naive HER2-positive brain metastases (cohort A) or progressive disease after radiotherapy (cohort B), with an Eastern Cooperative Oncology Group performance status of 0-2, received', 'eight tertiary hospitals in China', 'patients with at least one dose of study drug']","['pyrotinib plus capecitabine', 'pyrotinib 400 mg orally once daily, and capecitabine', 'Pyrotinib plus capecitabine', 'trastuzumab']","['diarrhoea', 'Activity and safety', 'activity and safety', 'intracranial objective response rate', 'intracranial objective response rate by investigator assessment according to the Response Evaluation Criteria', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721209', 'cui_str': 'Metastatic human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}]","[{'cui': 'C3828434', 'cui_str': 'pyrotinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",78.0,0.317691,The intracranial objective response rate was 74·6% (95% CI 61·6-85·0; 44 of 59 patients) in cohort A and 42·1% (20·3-66·5; eight of 19 patients) in cohort,"[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'Henan Breast Cancer Centre, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China. Electronic address: ym200678@126.com.'}, {'ForeName': 'Quchang', 'Initials': 'Q', 'LastName': 'Ouyang', 'Affiliation': 'Department of Breast Medicine, Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Breast Medicine, Cancer Hospital of China Medical University, Liaoning Cancer Hospital, Shenyang, China.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Niu', 'Affiliation': 'Henan Breast Cancer Centre, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Breast Cancer Centre, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Chunfang', 'Initials': 'C', 'LastName': 'Hao', 'Affiliation': 'Department of Breast Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China.'}, {'ForeName': 'Zhanhong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Breast Cancer Internal Medicine, Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou, China.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Orlandi', 'Affiliation': 'Unit of Medical Oncology, Fondazione Policlinico Universitario A Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Ishii', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, International University of Health and Welfare Hospital, Tochigi, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Takabe', 'Affiliation': 'Division of Breast Surgery, Roswell Park Comprehensive Cancer Centre, Buffalo, NY, USA.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Franceschini', 'Affiliation': 'Multidisciplinary Breast Centre, Fondazione Policlinico Universitario A Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Ricci', 'Affiliation': 'Clinique Croix du Sud, Quint-Fonsegrives, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Verschraegen', 'Affiliation': 'Ohio State University Comprehensive Cancer Centre, Columbus, OH, USA.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Henan Breast Cancer Centre, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Mengwei', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Henan Breast Cancer Centre, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': 'Henan Breast Cancer Centre, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Breast Medicine, Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Breast Medicine, Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Huawu', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Breast Medicine, Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Breast Medicine, Cancer Hospital of China Medical University, Liaoning Cancer Hospital, Shenyang, China.'}, {'ForeName': 'Xiaorui', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Breast Medicine, Cancer Hospital of China Medical University, Liaoning Cancer Hospital, Shenyang, China.'}, {'ForeName': 'Fangyuan', 'Initials': 'F', 'LastName': 'Dong', 'Affiliation': 'Breast Medicine, Cancer Hospital of China Medical University, Liaoning Cancer Hospital, Shenyang, China.'}, {'ForeName': 'Xiuchun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Henan Breast Cancer Centre, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Jianghua', 'Initials': 'J', 'LastName': 'Qiao', 'Affiliation': 'Henan Breast Cancer Centre, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Guifang', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Xinxiang Central Hospital, Xinxiang, China.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00716-6']
1756,35085482,"Rectal indometacin to prevent pancreatitis after extracorporeal shock wave lithotripsy (RIPEP): a single-centre, double-blind, randomised, placebo-controlled trial.","BACKGROUND


Pancreatitis is the most common complication of pancreatic extracorporeal shock wave lithotripsy (ESWL). There has been little research into effective prevention of post-ESWL pancreatitis. Therefore, we aimed to assess the efficacy of prophylactic rectal indometacin in preventing post-ESWL pancreatitis.
METHODS


In this double-blind, randomised, placebo-controlled trial done at Changhai Hospital (Shanghai, China), patients aged 18 years or older with chronic pancreatitis and pancreatic stones (>5 mm in diameter) who were eligible for treatment with ESWL were randomly allocated using a computer-generated randomisation table, in a 1:1 ratio, to receive 100 mg rectal indometacin or identical glycerin (placebo) suppositories 30 min before ESWL. Patients, endoscopists, and outcome assessors were masked to group allocation. The primary outcome was the incidence of post-ESWL pancreatitis within 24 h of ESWL, analysed by the intention-to-treat principle. This study is registered with ClinicalTrials.gov, number NCT02797067.
FINDINGS


Between May 31, 2016, and June 26, 2019, 1370 patients were enrolled, with 685 patients randomly assigned to the rectal indometacin group and 685 patients to the placebo group. All patients received their allocated intervention and completed final follow-up, and were included in the intention-to-treat analysis. Post-ESWL pancreatitis occurred in 60 (9%) patients in the rectal indometacin group and 84 (12%) patients in the placebo group (relative risk 0·71, 95% CI 0·52-0·98; p=0·042). Transient adverse events occurred in 235 (34%) patients in the rectal indometacin group and 252 (37%) patients in the placebo group, with asymptomatic hyperamylasaemia being the most common (189 [28%] patients vs 197 [29%] patients). No difference was noted between groups in the incidence of other complications and transient adverse events.
INTERPRETATION


Pre-procedural administration of rectal indometacin is an efficacious and safe means of reducing the incidence of post-ESWL pancreatitis.
FUNDING


Programs of Shanghai Municipal Government and the ""Ten Thousand Plan""-National High Level Talents Special Support Plan.",2022,"No difference was noted between groups in the incidence of other complications and transient adverse events.
","['1370 patients were enrolled, with 685 patients randomly assigned to the', 'Between May 31, 2016, and June 26, 2019', 'patients aged 18 years or older with chronic pancreatitis and pancreatic stones (>5 mm in diameter) who were eligible for treatment with ESWL', 'group and 685 patients to the']","['placebo', 'pancreatic extracorporeal shock wave lithotripsy (ESWL', 'Rectal indometacin', '100 mg rectal indometacin or identical glycerin (placebo) suppositories 30 min before ESWL', 'prophylactic rectal indometacin', 'extracorporeal shock wave lithotripsy (RIPEP', 'rectal indometacin']","['incidence of other complications and transient adverse events', 'Post-ESWL pancreatitis', 'incidence of post-ESWL pancreatitis within 24 h of ESWL, analysed by the intention-to-treat principle', 'Transient adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0149521', 'cui_str': 'Chronic pancreatitis'}, {'cui': 'C0440736', 'cui_str': 'Pancreatic stone'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C1617085', 'cui_str': 'Glycerin Rectal Suppository'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]",1370.0,0.905965,"No difference was noted between groups in the incidence of other complications and transient adverse events.
","[{'ForeName': 'Yang-Yang', 'Initials': 'YY', 'LastName': 'Qian', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Ru', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.'}, {'ForeName': 'Wen-Bin', 'Initials': 'WB', 'LastName': 'Zou', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xin', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.'}, {'ForeName': 'Ji-Yao', 'Initials': 'JY', 'LastName': 'Guo', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.'}, {'ForeName': 'Xin-Ying', 'Initials': 'XY', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.'}, {'ForeName': 'Liang-Hao', 'Initials': 'LH', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.'}, {'ForeName': 'Zhen-Dong', 'Initials': 'ZD', 'LastName': 'Jin', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.'}, {'ForeName': 'Yi-Qi', 'Initials': 'YQ', 'LastName': 'Du', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.'}, {'ForeName': 'Luo-Wei', 'Initials': 'LW', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.'}, {'ForeName': 'Zhao-Shen', 'Initials': 'ZS', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; Shanghai Institute of Pancreatic Diseases, Shanghai, China. Electronic address: liaozhuan@smmu.edu.cn.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(21)00434-9']
1757,35086041,Ozone exposure and prothrombosis: Mechanistic insights from a randomized controlled exposure trial.,"Epidemiological studies have associated ozone exposure with cardiovascular diseases, but the molecular mechanisms were not elucidated. We performed an untargeted serum proteomic analysis in a randomized, crossover, controlled exposure trial. We recruited 32 healthy young adults and asked them to receive filtered air and 200-ppb ozone exposures for 2 h in a random order before serum collection. Linear mixed-effect models were used to identify differentially expressed proteins (DEPs) between the two exposures and Gene Ontology enrichment and ingenuity pathway analysis were performed to determine their biological function. A total of 56 DEPs were identified. For example, acute ozone exposure increased coagulation factor X and factor VII-activating protease by 20.96% and 28.35%, respectively. Whereas, protein Z, protein Z-dependent protease inhibitor, and plasminogen decreased by 13.62%, 33.54%, and 10.47%, respectively. We also observed a 42.32% decrease in paraoxonase 3 and evident changes in four apolipoproteins. Additionally, we found 18.21% and 95.82% increases in L-selectin and β2-microglobulin, respectively, and significant changes in three complements. DEPs and enriched pathways suggest that short-term ozone exposure may promote coagulation, suppress fibrinolysis, disrupt lipoprotein metabolism, activate immune responses, and affect the complement system. These findings provide additional insights into the mechanisms linking acute ozone exposure to thrombosis.",2022,"For example, acute ozone exposure increased coagulation factor X and factor VII-activating protease by 20.96% and 28.35%, respectively.",['32 healthy young adults'],"['Ozone exposure and prothrombosis', 'filtered air and 200-ppb ozone exposures']","['coagulation factor X and factor VII-activating protease', 'protein Z, protein Z-dependent protease inhibitor, and plasminogen', 'L-selectin and β2-microglobulin']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032441', 'cui_str': 'Polybrominated biphenyl'}]","[{'cui': 'C0015518', 'cui_str': 'factor X'}, {'cui': 'C0015502', 'cui_str': 'factor VII'}, {'cui': 'C0030940', 'cui_str': 'Peptide Hydrolases'}, {'cui': 'C0071207', 'cui_str': 'plasma protein Z'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0032140', 'cui_str': 'Plasminogen'}, {'cui': 'C0125090', 'cui_str': 'Lymphocyte antigen CD62L'}]",56.0,0.0453799,"For example, acute ozone exposure increased coagulation factor X and factor VII-activating protease by 20.96% and 28.35%, respectively.","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Niu', 'Affiliation': 'School of Public Health, Shanghai Institute of Infectious Disease and Biosecurity, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Huichu', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Environmental Health, Harvard TH Chan School of Public Health, Boston, MA 02215, USA.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'School of Public Health, Shanghai Institute of Infectious Disease and Biosecurity, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Cuiping', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'School of Public Health, Shanghai Institute of Infectious Disease and Biosecurity, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'School of Public Health, Shanghai Institute of Infectious Disease and Biosecurity, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Xihao', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'School of Public Health, Shanghai Institute of Infectious Disease and Biosecurity, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Qingli', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'School of Public Health, Shanghai Institute of Infectious Disease and Biosecurity, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Jingguang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Shanghai Research Institute of Building Sciences (Group) Co., Ltd., Shanghai 200032, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'School of Public Health, Shanghai Institute of Infectious Disease and Biosecurity, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'School of Public Health, Shanghai Institute of Infectious Disease and Biosecurity, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Renjie', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'School of Public Health, Shanghai Institute of Infectious Disease and Biosecurity, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai 200032, China. Electronic address: chenrenjie@fudan.edu.cn.'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Kan', 'Affiliation': ""School of Public Health, Shanghai Institute of Infectious Disease and Biosecurity, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai 200032, China; Children's Hospital of Fudan University, National Center for Children's Health, Shanghai 201102, China. Electronic address: kanh@fudan.edu.cn.""}]",Journal of hazardous materials,['10.1016/j.jhazmat.2022.128322']
1758,35088079,A randomized clinical trial of guided self-help intervention based on mindfulness for patients with hepatocellular carcinoma: effects and mechanisms.,"BACKGROUND


Compared with face-to-face mindfulness-based interventions (MBIs), online mindfulness interventions may be more convenient for patients with limited resources and can provide self-help mindfulness methods to improve the quality of life of cancer patients. This study investigated the effects of guided self-help mindfulness-based interventions (GSH-MBIs) on psychological distress, quality of life and sleep quality in patients with hepatocellular carcinoma and explored the underlying mechanisms.
METHODS


A total of 122 patients with hepatocellular carcinoma were randomly divided into the intervention group or the conventional treatment group. Psychological distress, quality of life, sleep quality, psychological flexibility and perceived stress were evaluated in the groups before the intervention at baseline, after the intervention, at 1-month follow-up and 3-month follow-up. The intervention's effects over time and the potential mediating effects were analysed using generalized estimating equations (GEE).
RESULTS


GEE results indicated significant time-group interaction effects on psychological distress (P < 0.001) and sleep quality (P < 0.001). The intervention significantly improved psychological flexibility (β, -2.066; 95% CI, -3.631, -0.500) and reduced perceived stress (β, -2.639; 95% CI, -4.110, -1.169). Psychological flexibility and perceived stress played a mediating role in the observed results.
CONCLUSION


GSH-MBIs can improve psychological distress and sleep quality via changing the psychological flexibility and perceived stress in hepatocellular carcinoma patients.",2022,"The intervention significantly improved psychological flexibility (β, -2.066; 95% CI, -3.631, -0.500) and reduced perceived stress (β, -2.639; 95% CI, -4.110, -1.169).","['patients with hepatocellular carcinoma', 'hepatocellular carcinoma patients', '122 patients with hepatocellular carcinoma']","['GSH-MBIs', 'Compared with face-to-face mindfulness-based interventions (MBIs), online mindfulness interventions', 'conventional treatment group', 'guided self-help intervention', 'guided self-help mindfulness-based interventions (GSH-MBIs']","['psychological distress and sleep quality', 'Psychological flexibility', 'sleep quality', 'psychological distress', 'Psychological distress, quality of life, sleep quality, psychological flexibility and perceived stress', 'psychological flexibility', 'psychological distress, quality of life and sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}]","[{'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",122.0,0.0406866,"The intervention significantly improved psychological flexibility (β, -2.066; 95% CI, -3.631, -0.500) and reduced perceived stress (β, -2.639; 95% CI, -4.110, -1.169).","[{'ForeName': 'Zengxia', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, Jilin University, Changchun.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Invasive Technology Department, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'School of Nursing, Jilin University, Changchun.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Jilin University, Changchun.'}, {'ForeName': 'Lufang', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'School of Nursing, Jilin University, Changchun.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Jilin University, Changchun.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Jilin University, Changchun.'}]",Japanese journal of clinical oncology,['10.1093/jjco/hyab198']
1759,35086420,Beyond the pain: A qualitative study exploring the physical therapy experience in patients with chronic low back pain.,"BACKGROUND


Chronic low back pain (cLBP) is a complex condition that is physically and psychologically debilitating, with vulnerable populations experiencing more severe outcomes. Physical therapy (PT) includes evidence-based treatments that can reduce disability, however the experience of PT can vary amongst different populations. Empirical evidence is largely based on majority samples that are predominantly white with high educational attainment. Little is known regarding how people from vulnerable groups (e.g. low income and racial minority) experience physical therapy treatment for low back pain.
OBJECTIVE


To describe the experience of physical therapy in a predominantly low-income and minority population with cLBP.
METHODS


This qualitative study was embedded within a randomized controlled trial for patients with cLBP in urban, underserved communities. We used a convenience sample to interview 12 participants from the 102 who participated in the PT arm of the trial and then performed thematic analysis to describe their experience.
RESULTS


Three major themes emerged: 1) Empowerment through education and exercise; 2) Interconnectedness to providers and other patients; and 3) Improvements in pain, body mechanics, and mood. Divergent cases were few however centered around a lack of improvement in pain or an absence of connection with the therapist. Within the first theme a prevailing sub-theme emerged that aligned with Bandura's theory of self-efficacy: 1) Mastery of experience; 2) Verbal persuasion; 3) Vicarious experience; and 4) Physiological state.
CONCLUSIONS


Our participants' insight highlighted the value of cognitive-emotional and interpersonal dimensions of PT. These may be particularly important components of PT in populations that have experienced systemic distrust in providers and disparities in services. Future work could use Bandura's model of self-efficacy to build a PT intervention comprised of fear-based movement exercises, interconnectedness, a strong therapeutic alliance, and mindfulness techniques.",2022,"RESULTS


Three major themes emerged:","['patients with cLBP in urban, underserved communities', 'Chronic low back pain (cLBP', 'patients with chronic low back pain', 'convenience sample to interview 12 participants from the 102 who participated in the PT arm of the trial and then performed thematic analysis to describe their experience', 'a predominantly low-income and minority population with cLBP']",['Physical therapy (PT'],"['pain, body mechanics, and mood', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",102.0,0.033526,"RESULTS


Three major themes emerged:","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Joyce', 'Affiliation': 'School of Physical Therapy, Massachusetts College of Pharmacy and Health Sciences, Worcester, MA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Keysor', 'Affiliation': 'Department of Rehabilitation Science, Massachusetts General Hospital Institute of Health Professions, MA, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Stevans', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Ready', 'Affiliation': 'Boston University Medical Center.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Roseen', 'Affiliation': 'Department of Rehabilitation Science, Massachusetts General Hospital Institute of Health Professions, MA, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Saper', 'Affiliation': 'Department of Wellness and Preventative Medicine, Cleveland Clinic, Cleveland, OH, USA.'}]",Physiotherapy theory and practice,['10.1080/09593985.2022.2029650']
1760,35085715,Is Radiation-Induced Cardiac Toxicity Reversible? Prospective Evaluation of Patients With Breast Cancer Enrolled in a Phase 3 Randomized Controlled Trial.,"PURPOSE


Myocardial perfusion defects after breast radiation therapy (RT) correlate with volume of irradiated left ventricle (LV). We aimed to determine the relationship between myocardial perfusion, LV dosimetry, and grade ≥2 late cardiac events in patients with breast cancer undergoing adjuvant RT.
METHODS AND MATERIALS


A randomized study evaluated the benefit of inverse-planned intensity modulated radiation therapy over forward-planned intensity modulated radiation therapy for radiation toxicity in breast cancer. A secondary endpoint was evaluating cardiac perfusion by single-photon emission computed tomography done at baseline, 6 months, 1 year, 2 years, and 5 years post-RT. We used receiver operating curve and regression analysis to identify association between perfusion, radiation dose-volumes, and the risk of late cardiac events.
RESULTS


Of 181 patients who received adjuvant RT, 102 were patients with cancer in the left breast (called in this study the left-sided group) and 79 were patients with cancer in the right breast (called in this study the right-sided group). Median follow-up was 127 months (range, 19-160 months). A significant worsening of perfusion defects occurred after RT in the left-sided group, which improved by 1 year. Late cardiac events were found among 16 patients (17.2%) in the left-sided group and 4 patients (5.5%) in the right-sided group. Perfusion changes did not correlate with late cardiac events, but LV dose-volumes correlated with late cardiac events. Maintaining the LV volume receiving 5 Gy and 10 Gy to <42 cc and <38cc, respectively, can reduce the risk of radiation-related late cardiac events at 10 years to <5% over baseline.
CONCLUSIONS


RT was associated with short-term perfusion defects that improved within 1 year and was not correlated with late cardiac events. The ventricular volumes receiving 5 Gy and 10 Gy were correlated with late cardiac events.",2022,"CONCLUSIONS AND RELEVANCE


RT was associated with short-term perfusion defects that improved within 1 year and was not correlated with late cardiac events.","['breast cancer', 'breast cancer (BC) patients undergoing adjuvant RT', 'breast cancer patients', '181 patients that received adjuvant RT, 102 were left-sided and 79 were right breast cancer patients']","['breast radiotherapy (RT', 'inverse-planned intensity modulated radiotherapy (IMRT']","['late cardiac events', 'perfusion defects', 'risk of radiation related late cardiac events']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0222600', 'cui_str': 'Right breast structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0852216', 'cui_str': 'Breast radiotherapies'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]",181.0,0.125047,"CONCLUSIONS AND RELEVANCE


RT was associated with short-term perfusion defects that improved within 1 year and was not correlated with late cardiac events.","[{'ForeName': 'Aswin', 'Initials': 'A', 'LastName': 'Abraham', 'Affiliation': 'Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Karan Paul', 'Initials': 'KP', 'LastName': 'Sanghera', 'Affiliation': 'Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Gheisari', 'Affiliation': 'Department of Nuclear Medicine, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Koumna', 'Affiliation': 'Department of Nuclear Medicine, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Riauka', 'Affiliation': 'Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Warkentin', 'Affiliation': 'Division of Medical Physics, Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Gabos', 'Affiliation': 'Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Chafe', 'Affiliation': 'Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Tankel', 'Affiliation': 'Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Fleur', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Siham', 'Initials': 'S', 'LastName': 'Sabri', 'Affiliation': 'Division of Experimental Oncology, Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'David Ian', 'Initials': 'DI', 'LastName': 'Paterson', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Abdulkarim', 'Affiliation': 'Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kurian', 'Initials': 'K', 'LastName': 'Joseph', 'Affiliation': 'Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada. Electronic address: kurian.joseph@albertahealthservices.ca.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2022.01.020']
1761,35089872,Evaluation of a Nurse-led Aftercare Intervention for Patients With Head and Neck Cancer Treated With Radiotherapy and Cisplatin or Cetuximab.,"BACKGROUND


The supportive needs for head and neck cancer (HNC) patients during the vulnerable period after treatment are not always met. Therefore, more professional support regarding physical, social, and psychological care as well as lifestyle is recommended.
OBJECTIVE


This study is an evaluation of a nurse-led aftercare intervention to support patients recovering from HNC treatment.
METHODS


Intervention group (IG) participants received 2 extra consultations from a nurse practitioner 3 and 9 months after treatment of HNC. A holistic conversational tool, the Self-Management Web, was developed to guide the nurse through the conversation. Primary outcomes were health-related quality of life (HRQoL) and quality of patient-centered care. A secondary outcome was self-management skills.
RESULTS


Twenty-seven patients were included in the IG, and 28 were included in the control group. Differences in HRQoL and self-management between the IG and the control group were not statistically significant. For the IG, all domains of the Self-Management Web were perceived important and addressed by the nurse practitioner.
CONCLUSION


This holistic nurse-led aftercare intervention was highly appreciated by HNC patients. Although the intervention met the need for support in recovery after treatment, it did not improve HRQoL or self-management skills.
IMPLICATIONS OF PRACTICE


For both nurses and patients, the intervention is feasible and acceptable in daily practice. Self-management support for patients after their cancer treatment is of added value and has potential to improve the quality of regular follow-up care.",2022,"Although the intervention met the need for support in recovery after treatment, it did not improve HRQoL or self-management skills.
","['head and neck cancer (HNC) patients', 'Patients With Head and Neck Cancer', 'Twenty-seven patients were included in the IG, and 28 were included in the control group', 'patients recovering from HNC treatment']","['Radiotherapy and Cisplatin or Cetuximab', 'Nurse-led Aftercare Intervention', 'nurse-led aftercare intervention']","['self-management skills', 'health-related quality of life (HRQoL) and quality of patient-centered care', 'HRQoL and self-management']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0243024', 'cui_str': 'Patient-Centered Care'}]",27.0,0.0116525,"Although the intervention met the need for support in recovery after treatment, it did not improve HRQoL or self-management skills.
","[{'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Braat', 'Affiliation': 'Author Affiliations: Department of Radiotherapy, Erasmus MC Cancer Institute, University Medical Center Rotterdam (Ms Braat and Dr Verduijn); Research Center Innovations in Care, Rotterdam University of Applied Sciences (Drs van der Stege and van Staa, and Ms Peeters); and Departments of Head and Neck Oncology (Dr Offerman) and Medical Oncology (Dr Oldenmenger), Erasmus MC Cancer Institute, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Gerda M', 'Initials': 'GM', 'LastName': 'Verduijn', 'Affiliation': ''}, {'ForeName': 'Heleen A', 'Initials': 'HA', 'LastName': 'van der Stege', 'Affiliation': ''}, {'ForeName': 'Marinella P J', 'Initials': 'MPJ', 'LastName': 'Offerman', 'Affiliation': ''}, {'ForeName': 'Mariëlle A C', 'Initials': 'MAC', 'LastName': 'Peeters', 'Affiliation': ''}, {'ForeName': 'AnneLoes', 'Initials': 'A', 'LastName': 'van Staa', 'Affiliation': ''}, {'ForeName': 'Wendy H', 'Initials': 'WH', 'LastName': 'Oldenmenger', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000983']
1762,35090839,Attachment and Childhood Maltreatment as Moderators of Treatment Outcome in a Randomized Clinical Trial for Provoked Vestibulodynia.,"BACKGROUND


Although distal developmental factors, such as attachment and childhood maltreatment (CM), are associated with the occurrence, severity, and adjustment to provoked vestibulodynia (PVD)-the most prevalent form of vulvodynia-no studies to date have examined whether these variables are related to treatment efficacy in the context of PVD. Attachment and CM may act as moderating variables when examining different treatment modalities, whereby individuals with more insecure attachment orientations (anxiety/avoidance) or a history of CM may benefit less from treatments with higher interpersonal contexts, such as sex and couple therapy-a recommended treatment for PVD.
AIM


The present randomized clinical trial (RCT) examined attachment and CM as predictors and moderators of sexual satisfaction, distress, and function at post-treatment and 6-month follow-up while comparing 2 treatments for PVD: Topical lidocaine, and a novel cognitive behavioral couple therapy focused on women's pain and partners' sexuality.
METHODS


One hundred eight women with PVD were randomized to a 12-week treatment of either lidocaine or couple therapy. Women completed questionnaires at pretreatment, post-treatment, and at a 6-month follow-up.
OUTCOMES


(1) Global Measure of Sexual Satisfaction; (2) Female Sexual Distress Scale-Revised; (3) Female Sexual Function Index.
RESULTS


Both attachment and CM were significant moderators of treatment outcomes. At either post-treatment or 6-month follow-up, in the couple therapy condition, women with greater attachment avoidance had poorer outcomes on sexual distress, satisfaction and function, whereas women with higher levels of CM had poorer outcomes on sexual satisfaction and sexual function, compared to women in the lidocaine condition.
CLINICAL IMPLICATIONS


Although these novel findings need further replication, they highlight the importance for clinicians to take into account distal factors, for instance, attachment and CM, when treating sexual difficulties such as PVD, as these variables may affect more interpersonal dimensions of treatment (eg, trust, compliance, etc.) and ultimately, treatment progress.
STRENGTHS & LIMITATIONS


Using a rigorous RCT study design and statistical approach, this study is the first to examine attachment and CM as moderators in the treatment of sexual difficulties. It is however limited by the use of self-report measures, and further studies are necessary to validate the generalizability of current results to other sexual difficulties.
CONCLUSION


Findings support the role of interpersonal factors in the treatment of PVD and indicate that short-term psychological interventions, such as couple therapy, may be less beneficial for women with antecedents of CM and attachment insecurity. V Charbonneau-Lefebvre, M-P Vaillancourt-Morel, NO Rosen, et al. Attachment and Childhood Maltreatment as Moderators of Treatment Outcome in a Randomized Clinical Trial for Provoked Vestibulodynia. J Sex Med 2022;19:479-495.",2022,"At either post-treatment or 6-month follow-up, in the couple therapy condition, women with greater attachment avoidance had poorer outcomes on sexual distress, satisfaction and function, whereas women with higher levels of CM had poorer outcomes on sexual satisfaction and sexual function, compared to women in the lidocaine condition.
","[""women's pain and partners' sexuality"", 'One hundred eight women with PVD', 'PVD']","['lidocaine or couple therapy', 'Topical lidocaine']","['sexual distress, satisfaction and function', '1) Global Measure of Sexual Satisfaction; (2) Female Sexual Distress Scale-Revised; (3) Female Sexual Function Index', 'sexual satisfaction and sexual function', 'sexual satisfaction, distress, and function']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0269084', 'cui_str': 'Vulvar vestibulitis'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0302822', 'cui_str': 'Couple Therapy'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]",108.0,0.033782,"At either post-treatment or 6-month follow-up, in the couple therapy condition, women with greater attachment avoidance had poorer outcomes on sexual distress, satisfaction and function, whereas women with higher levels of CM had poorer outcomes on sexual satisfaction and sexual function, compared to women in the lidocaine condition.
","[{'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Charbonneau-Lefebvre', 'Affiliation': 'Department of Psychology, Université de Montréal, Montreal, Canada. Electronic address: veronique.charbonneau-lefebvre@umontreal.ca.'}, {'ForeName': 'Marie-Pier', 'Initials': 'MP', 'LastName': 'Vaillancourt-Morel', 'Affiliation': 'Department of Psychology, Université du Québec a Trois-Rivières, Trois-Rivières, Canada.'}, {'ForeName': 'Natalie O', 'Initials': 'NO', 'LastName': 'Rosen', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Steben', 'Affiliation': 'Department of Social and Preventive Medicine, Groupe de médecine familiale La Cité du Parc Lafontaine, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bergeron', 'Affiliation': 'Department of Psychology, Université de Montréal, Montreal, Canada.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2021.12.013']
1763,35090838,The Inventory of Anal Sex Knowledge (iASK): A New Measure of Sexual Health Knowledge Among Adolescent Sexual Minority Males.,"INTRODUCTION


Knowledge about sexual health is a key determinant of sexual behavior among adolescent sexual minority males (ASMM). No measures exist to assess anal sex knowledge, even though anal sex is the primary route by which ASMM acquire sexually transmitted infections (STIs), including a disproportionate burden of human immunodeficiency virus (HIV).
AIM


We developed a new measure as a first step toward assessing the prevalence and correlates of anal sex knowledge and potential effects of interventions to improve knowledge.
METHODS


Two coders independently outlined domains of knowledge within 2 sex education videos designed to address anal sex knowledge among ASMM. An initial set of 56 items, some duplicative, encompassed all domains. A larger team, including a psychometrician, then iteratively revised and reduced the set of items, and assessed construct validity via cognitive testing among ASMM (N = 4, aged 16-17 years old, 75% identifying as racial/ethnic minorities). For the final set of 10 items, factor structure and convergent and divergent validity were assessed using baseline responses to an online survey within a randomized controlled pilot trial among 154 ASMM. Open-ended questions assessed their comprehension and the acceptability of items.
OUTCOMES


We examined correlates that we anticipated would be theoretically related (ie, the HIV Knowledge Questionnaire [HIV-KQ-18] and the STD-Knowledge Questionnaire [STD-KQ]) and theoretically distinct (ie, the Patient Health Questionnaire [PHQ-2], Generalized Anxiety Disorder scale [GAD-2], and employment status).
RESULTS


The one-factor model explained 42% of the items' common variance and demonstrated acceptable internal reliability (Cronbach's alpha = 0.72). The measure withstood tests of convergent and divergent validity when compared to current measures (HIV knowledge, r = 0.35 and STI knowledge, r = 0.24, both P < .05; internalizing mental health symptoms, r = -0.07 and employment status, r = 0.13, both P > .05). Few respondents found words unfamiliar or uncomfortable.
CLINICAL IMPLICATIONS


A method for assessing anal sex knowledge may offer opportunities to intervene to lessen harmful sequelae of a lack of knowledge.
STRENGTH & LIMITATIONS


We developed a brief, psychometrically valid measure of anal sex knowledge. The measure may neither generalize to all anal health knowledge nor to more sexually experienced, older SMM.
CONCLUSION


The resulting 10-item, single-factor measure, the Inventory of Anal Sex Knowledge (iASK), is psychometrically sound and addresses the lack of anal sex knowledge measures among ASMM. The iASK can function to assess the prevalence and sequelae of anal sex knowledge among ASMM as well as the impact of interventions targeting anal sex knowledge. Kutner BA, Perry N, Stout C, et al. The Inventory of Anal Sex Knowledge (iASK): A New Measure of Sexual Health Knowledge Among Adolescent Sexual Minority Males. J Sex Med 2022;19:521-528.",2022,"The measure withstood tests of convergent and divergent validity when compared to current measures (HIV knowledge, r = 0.35 and STI knowledge, r = 0.24, both P < .05; internalizing mental health symptoms, r = -0.07 and employment status, r = 0.13, both P > .05).","['adolescent sexual minority males (ASMM', 'Adolescent Sexual Minority Males', 'Two coders independently outlined domains of knowledge within 2 sex education videos designed to address anal sex knowledge among ASMM', 'N\xa0=\xa04, aged 16-17 years old, 75% identifying as racial/ethnic minorities']",['ASMM'],"['resulting 10-item, single-factor measure, the Inventory of Anal Sex Knowledge (iASK', 'internalizing mental health symptoms', 'Inventory of Anal Sex Knowledge (iASK', 'Generalized Anxiety Disorder scale [GAD-2], and employment status', 'HIV Knowledge Questionnaire [HIV-KQ-18] and the STD-Knowledge Questionnaire [STD-KQ]) and theoretically distinct (ie, the Patient Health Questionnaire [PHQ-2', 'Sexual Health Knowledge', 'acceptable internal reliability', 'anal sex knowledge']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0600661', 'cui_str': 'Outlines'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036879', 'cui_str': 'Sexuality education'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C5197676', 'cui_str': 'GAD-2'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C2706101', 'cui_str': 'PHQ-2'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",154.0,0.0136069,"The measure withstood tests of convergent and divergent validity when compared to current measures (HIV knowledge, r = 0.35 and STI knowledge, r = 0.24, both P < .05; internalizing mental health symptoms, r = -0.07 and employment status, r = 0.13, both P > .05).","[{'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Kutner', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, New York, NY, USA. Electronic address: bak2133@cumc.columbia.edu.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Perry', 'Affiliation': 'Department of Psychology, University of Denver, CO, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Stout', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Norcini Pala', 'Affiliation': 'Social Intervention Group (SIG), Columbia School of Social Work, New York, NY, USA.'}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Paredes', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Kimberly M', 'Initials': 'KM', 'LastName': 'Nelson', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA; Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2021.12.011']
1764,35091313,Inverse relationship between body mass index and risk of venous thromboembolism among medically ill hospitalized patients: Observations from the APEX trial.,"Obesity is associated with cardiovascular complications such as diabetes and hypertension. However, obesity and high body mass index (BMI) can also be linked to improved clinical outcomes in certain patient populations. This counterintuitive observation is called the ""obesity paradox."" The effect of BMI on the risk of developing venous thromboembolism (VTE) in acutely ill medical patients remains unclear. In the Acute Medically Ill VTE Prevention with Extended Duration Betrixaban (APEX) trial, acutely ill hospitalized medical patients were randomized to receive either extended-duration betrixaban or shorter-duration enoxaparin and followed for 77 days. A total of 7372 patients with evaluable VTE endpoints had BMI measured at baseline. The association between BMI and VTE risk was assessed after adjusting for potential confounders. The multivariable adjusted ORs of VTE risk associated with BMI levels referencing the median BMI value (15, 18.5, 28.3 [reference], 35, 40, 45) were: 2.82 (95% CI, 1.32-6.04, [change from 28.3 to 15]), 1.85 (95% CI, 1.14-2.99, [change from 28.3 to 18.5]), 1.30 (95% CI, 1.04-1.63, [change from 28.3 to 35]), 1.13 (95% CI, 0.84-1.52, [change from 28.3 to 40]), and 0.91 (95% CI, 0.57-1.47, [change from 28.3 to 45]), respectively (p = 0.022). In conclusion, acutely ill hospitalized patients with lower BMI had a higher VTE risk through 77 days, which appears to be a manifestation of the BMI paradox.",2022,"The multivariable adjusted ORs of VTE risk associated with BMI levels referencing the median BMI value (15, 18.5, 28.3 [reference], 35, 40, 45) were: 2.82 (95% CI, 1.32-6.04, [change from 28.3 to 15]), 1.85 (95% CI, 1.14-2.99, [change from 28.3 to 18.5]), 1.30 (95% CI, 1.04-1.63, [change from 28.3 to 35]), 1.13 (95% CI, 0.84-1.52, [change from 28.3 to 40]), and 0.91 (95% CI, 0.57-1.47, [change from 28.3 to 45]), respectively (p = 0.022).","['medically ill hospitalized patients', 'acutely ill medical patients', 'acutely ill hospitalized patients with lower BMI', '7372 patients with evaluable VTE', 'Acute Medically Ill VTE Prevention with Extended Duration Betrixaban (APEX) trial, acutely ill hospitalized medical patients']","['BMI', 'extended-duration betrixaban or shorter-duration enoxaparin']","['BMI', 'BMI and VTE risk']","[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0231255', 'cui_str': 'Decreased body mass index'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2698385', 'cui_str': 'betrixaban'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2698385', 'cui_str': 'betrixaban'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",7372.0,0.413324,"The multivariable adjusted ORs of VTE risk associated with BMI levels referencing the median BMI value (15, 18.5, 28.3 [reference], 35, 40, 45) were: 2.82 (95% CI, 1.32-6.04, [change from 28.3 to 15]), 1.85 (95% CI, 1.14-2.99, [change from 28.3 to 18.5]), 1.30 (95% CI, 1.04-1.63, [change from 28.3 to 35]), 1.13 (95% CI, 0.84-1.52, [change from 28.3 to 40]), and 0.91 (95% CI, 0.57-1.47, [change from 28.3 to 45]), respectively (p = 0.022).","[{'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Kalayci', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States. Electronic address: akalayci@bidmc.harvard.edu.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke University and Duke Clinical Research Institute, Durham, NC, United States.'}, {'ForeName': 'Russell D', 'Initials': 'RD', 'LastName': 'Hull', 'Affiliation': 'Division of Cardiology, R.A.H Faculty of Medicine, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Cohen', 'Affiliation': ""Department of Haematological Medicine, Guy's and St Thomas' Hospitals, King's College, London, United Kingdom.""}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Fitzgerald', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Syed D', 'Initials': 'SD', 'LastName': 'Hussain', 'Affiliation': 'Baim Institute for Clinical Research, Boston, MA, United States.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Chi', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Alkhalfan', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Stanford University, Stanford, CA, United States.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}]",Thrombosis research,['10.1016/j.thromres.2022.01.016']
1765,35086120,Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial.,"SIGNIFICANCE


Treatment of myopic children with a dual-focus soft contact lens (DFCL; MiSight 1 day) produced sustained slowing of myopia progression over a 6-year period. Significant slowing was also observed in children switched from a single vision control to treatment lenses (3 years in each lens).
PURPOSE


This study aimed to evaluate the effectiveness of DFCLs in sustaining slowed progression of juvenile-onset myopia over a 6-year treatment period and assess myopia progression in children who were switched to a DFCL at the end of year 3.
METHODS


Part 1 was a 3-year clinical trial comparing DFCLs with a control contact lens (Proclear 1 day) at four investigational sites. In part 2, subjects completing part 1 were invited to continue for 3 additional years during which all children were treated with MiSight 1 day DFCLs (52 and 56 from the initially treated [T6] and control [T3] groups, respectively). Eighty-five subjects (45 [T3] and 40 [T6]) completed part 2. Cyclopleged spherical equivalent refractive errors (SEREs) and axial lengths (ALs) were monitored, and a linear mixed model was used to compare their adjusted change annually.
RESULTS


Average ages at part 2 baseline were 13.2 ± 1.3 and 13.0 ± 1.5 years for the T6 and T3 groups, respectively. Slowed myopia progression in the T6 group observed during part 1 was sustained throughout part 2 (mean ± standard error of the mean: change from baseline SERE [in diopters], -0.52 ± 0.076 vs. -0.51 ± 0.076; change in AL [in millimeters], 0.28 ± 0.033 vs. 0.23 ± 0.033; both P > .05). Comparing progression rates in part 2 for the T6 and T3 groups, respectively, indicates that prior treatment does not influence efficacy (SERE, -0.51 ± 0.076 vs. -0.34 ± 0.077; AL, 0.23 ± 0.03 vs. 0.18 ± 0.03; both P > .05). Within-eye comparisons of AL growth revealed a 71% slowing for the T3 group (3 years older than part 1) and further revealed a small subset of eyes (10%) that did not respond to treatment.
CONCLUSIONS


Dual-focus soft contact lenses continue to slow the progression of myopia in children over a 6-year period revealing an accumulation of treatment effect. Eye growth of the initial control cohort with DFCL was slowed by 71% over the subsequent 3-year treatment period.",2022,Eye growth of the initial control cohort with DFCL was slowed by 71% over the subsequent 3-year treatment period.,"['85 subjects (45 (T3) and 40 (T6)) completed Part 2', 'Children', 'myopic children with a dual-focus soft contact lens (DFCL', 'children who were switched to DFCL at the end of year 3']","['Dual-Focus Contact Lenses', 'DFCLs', 'DFCLs with control CLs']","['myopia progression', 'progression rates', 'Cyclopleged spherical equivalent refractive errors (SERE) and axial lengths (AL', 'Myopia Progression', 'Slowed myopia progression']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006790', 'cui_str': 'Calusterone'}]","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439834', 'cui_str': 'Slow'}]",85.0,0.070118,Eye growth of the initial control cohort with DFCL was slowed by 71% over the subsequent 3-year treatment period.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chamberlain', 'Affiliation': ''}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Bradley', 'Affiliation': 'CooperVision Inc., Pleasanton, California.'}, {'ForeName': 'Baskar', 'Initials': 'B', 'LastName': 'Arumugam', 'Affiliation': 'CooperVision Inc., Pleasanton, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'CooperVision Inc., Pleasanton, California.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McNally', 'Affiliation': 'CooperVision Inc., Pleasanton, California.'}, {'ForeName': 'Nicola S', 'Initials': 'NS', 'LastName': 'Logan', 'Affiliation': 'Ophthalmic Research Group, School of Optometry, Aston University, Aston Triangle, Birmingham, United Kingdom.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Centre for Ocular Research and Education, School of Optometry and Vision Science, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Ngo', 'Affiliation': 'Department of Ophthalmology, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Sofia C', 'Initials': 'SC', 'LastName': 'Peixoto-de-Matos', 'Affiliation': 'Clinical and Experimental Optometry Research Lab, Centre of Physics, School of Sciences, University of Minho, Braga, Portugal.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hunt', 'Affiliation': 'Visioncare Research Ltd., Farnham, Surrey, United Kingdom.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': 'Visioncare Research Ltd., Farnham, Surrey, United Kingdom.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001873']
1766,35091711,NEAR trial: A single-arm phase II trial of neoadjuvant apalutamide monotherapy and radical prostatectomy in intermediate- and high-risk prostate cancer.,"OBJECTIVE


Treatment efficacy of androgen deprivation therapy with radical prostatectomy for intermediate- to high-risk prostate cancer is less well-studied. The NEAR trial is a single-arm, phase II investigation of neoadjuvant apalutamide monotherapy and radical prostatectomy (RP) in the treatment of D'Amico intermediate- and high-risk prostate cancer (NCT03124433).
MATERIALS AND METHODS


Patients with histologically-proven, D'Amico intermediate- to high-risk prostate adenocarcinoma received apalutamide 240 mg once-daily for 12 weeks followed by RP + /-lymphadenectomy. Primary outcome was pathological complete response (pCR) rate. Secondary outcomes included rate of biochemical response (defined by PSA < 0.03 ng/mL at week 24 from starting apalutamide without subsequent PSA relapse), treatment-related adverse events, and RP complication rates. Correlative biomarker analyses were performed to examine for molecular predictors of treatment responses.
RESULTS


From 2017 to 2019, 30 patients were recruited, of which 20 and 10 were high and intermediate risk, respectively; 25 completed treatment as per-protocol. We did not observe any pCR on trial; median reduction of cancer burden was 41.7% (IQR: 33.3%-60.0%). 18 out of 25 patients were classified as having a biochemical response (4 did not achieve PSA of <0.03 ng/mL at week 24 and 3 developed PSA relapse subsequently). Dry skin (N = 16; 53.3%), fatigue (N = 10; 33.3%) and skin rash (N = 9; 30.0%) were the most common adverse events, and there was no major peri-operative complication. We observed an association between tumours of low androgen receptor activity and PAM50 basal status with biochemical non-responders, albeit these molecular phenotypes were not associated with pathological response.
CONCLUSIONS


A 12-week course of neoadjuvant apalutamide prior to RP did not meet the primary endpoint of pCR in this trial. Tumours with low androgen receptor activity or of the PAM50 basal subtype may have a reduced response to apalutamide.",2022,18 out of 25 patients were classified as having a biochemical response (4 did not achieve PSA of <0.03 ng/mL at week 24 and 3 developed PSA relapse subsequently).,"[""Patients with histologically-proven, D'Amico intermediate- to high-risk prostate adenocarcinoma"", 'intermediate- and high-risk prostate cancer', 'From 2017 to 2019, 30 patients were recruited, of which 20 and 10 were high and intermediate risk, respectively; 25 completed treatment as per-protocol']","['apalutamide 240\u2009mg once-daily for 12 weeks followed by RP\u2009+\u2009/-lymphadenectomy', 'androgen deprivation therapy with radical prostatectomy', 'neoadjuvant apalutamide monotherapy and radical prostatectomy (RP', 'neoadjuvant apalutamide monotherapy and radical prostatectomy']","['rate of biochemical response', 'skin rash', 'pathological complete response (pCR) rate', 'cancer burden', 'fatigue', 'PSA relapse), treatment-related adverse events, and RP complication rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007112', 'cui_str': 'Adenocarcinoma of prostate'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",25.0,0.253422,18 out of 25 patients were classified as having a biochemical response (4 did not achieve PSA of <0.03 ng/mL at week 24 and 3 developed PSA relapse subsequently).,"[{'ForeName': 'Lui Shiong', 'Initials': 'LS', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Sengkang General Hospital, Singapore, Singapore. lee.lui.shiong@singhealth.com.sg.'}, {'ForeName': 'Adelene Y L', 'Initials': 'AYL', 'LastName': 'Sim', 'Affiliation': 'Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Chee Wee', 'Initials': 'CW', 'LastName': 'Ong', 'Affiliation': 'Department of Urology, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Xinyan', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Cedric C Y', 'Initials': 'CCY', 'LastName': 'Ng', 'Affiliation': 'Division of Medical Sciences, National Cancer Centre Singapore, Singapore, Singapore.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Division of Medical Sciences, National Cancer Centre Singapore, Singapore, Singapore.'}, {'ForeName': 'Vikneswari', 'Initials': 'V', 'LastName': 'Rajasegaran', 'Affiliation': 'Division of Medical Sciences, National Cancer Centre Singapore, Singapore, Singapore.'}, {'ForeName': 'Abner M S', 'Initials': 'AMS', 'LastName': 'Lim', 'Affiliation': 'Division of Medical Sciences, National Cancer Centre Singapore, Singapore, Singapore.'}, {'ForeName': 'Edwin Jonathan', 'Initials': 'EJ', 'LastName': 'Aslim', 'Affiliation': 'Department of Urology, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Nye-Thane', 'Initials': 'NT', 'LastName': 'Ngo', 'Affiliation': 'Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Li-Yan', 'Initials': 'LY', 'LastName': 'Khor', 'Affiliation': 'Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Ravindran', 'Initials': 'R', 'LastName': 'Kanesvaran', 'Affiliation': 'Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'John Carson Jr', 'Initials': 'JCJ', 'LastName': 'Allen', 'Affiliation': 'Center for Quantitative Medicine/Office of Research, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Kae Jack', 'Initials': 'KJ', 'LastName': 'Tay', 'Affiliation': 'Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'John Shyi Peng', 'Initials': 'JSP', 'LastName': 'Yuen', 'Affiliation': 'Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Tsung Wen', 'Initials': 'TW', 'LastName': 'Chong', 'Affiliation': 'Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Sun Sien Henry', 'Initials': 'SSH', 'LastName': 'Ho', 'Affiliation': 'Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Bin Tean', 'Initials': 'BT', 'LastName': 'Teh', 'Affiliation': 'Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Melvin L K', 'Initials': 'MLK', 'LastName': 'Chua', 'Affiliation': 'Duke-NUS Medical School, Singapore, Singapore.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-022-00496-8']
1767,35092498,A study for every second day administration of vonoprazan for maintenance treatment of erosive GERD (ESD von GERD): a multicenter randomized cross-over study.,"BACKGROUND


Vonoprazan is a potassium competitive acid blocker used to treat erosive gastroesophageal reflux disease (GERD) with stronger, more stable acid-suppressing effects than proton pump inhibitors (PPIs). This study clarified the usefulness and superiority of vonoprazan administered every second day over PPIs in the maintenance therapy of erosive GERD.
METHODS


This is a prospective, multicenter, open-label, two-period randomized cross-over study. Patients were randomized to either the vonoprazan-lansoprazole (VP-LZ) group, who were given vonoprazan 10 mg for the first 4 weeks and then lansoprazole 15 mg for the next 4 weeks both administered once every second day, or the lansoprazole-vonoprazan (LZ-VP) group, who were treated in reverse. GERD symptoms were compared using symptom diaries, the frequency scale for symptoms of GERD (FSSG), and the gastrointestinal symptom rating scale (GSRS).
RESULTS


We enrolled 122 patients between December 2017 and May 2019. Symptoms were well controlled in vonoprazan administration and lansoprazole administration were 93.6% and 82.1%, respectively, with a significant difference on McNemar's test (P = 0.003). During the second 4 weeks, 94.4% and 76.7% of patients in the VP-LZ and LZ-VP groups, respectively, were well controlled following for ≥ 6 consecutive days a week (P = 0.009). During the first 4 weeks, 96.7% and 80.0% of patients were well controlled with < 1 weekly in the VP-LZ and LZ-VP groups, respectively, during the first 4 weeks (P = 0.007). GERD symptoms, assessed via FSSG and GSRS, significantly decreased with vonoprazan administration once every second day.
CONCLUSIONS


Vonoprazan administered once every second day could be an effective alternative to PPIs in the maintenance treatment of erosive GERD (UMIN000030393).",2022,"GERD symptoms, assessed via FSSG and GSRS, significantly decreased with vonoprazan administration once every second day.
","['erosive GERD (ESD von GERD', 'We enrolled 122 patients between December 2017 and May 2019']","['vonoprazan 10\xa0mg for the first 4\xa0weeks and then lansoprazole', 'vonoprazan-lansoprazole (VP-LZ', 'Vonoprazan', 'vonoprazan', 'lansoprazole', 'lansoprazole-vonoprazan (LZ-VP']","['frequency scale for symptoms of GERD (FSSG), and the gastrointestinal symptom rating scale (GSRS', 'GERD symptoms, assessed via FSSG and GSRS', 'GERD symptoms', ""McNemar's test""]","[{'cui': 'C0439679', 'cui_str': 'Erosive'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C4080009', 'cui_str': 'Vonoprazan'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",122.0,0.0593411,"GERD symptoms, assessed via FSSG and GSRS, significantly decreased with vonoprazan administration once every second day.
","[{'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Matsuda', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Hakodate National Hospital, 18-16, Kawahara-chou, Hakodate, Hokkaido, 041-8512, Japan.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Hakodate National Hospital, 18-16, Kawahara-chou, Hakodate, Hokkaido, 041-8512, Japan. mkato1957@gmail.com.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Sakakibara', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Hiroshige', 'Initials': 'H', 'LastName': 'Hamada', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Higashihiroshima Medical Center, Hiroshima, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Sasaki', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Disaster Medical Center, Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Mori', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Hirai', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Kochi National Hospital, Kochi, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Toyokawa', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Fukuyama Medical Center, Hiroshima, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kagaya', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Kanazawa Medical Center, Ishikawa, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kuwai', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Kure Medical Center, Hiroshima, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Esaka', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Haruhiro', 'Initials': 'H', 'LastName': 'Yamashita', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Mie Chou Medical Center, Mie, Japan.'}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Hokkaido Medical Center, Hokkaido, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Fukuokahigashi Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Mamiko', 'Initials': 'M', 'LastName': 'Demura', 'Affiliation': 'Department of Clinical Research, National Hospital Organization Hakodate National Hospital, Hokkaido, Japan.'}, {'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Kubo', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Hakodate National Hospital, 18-16, Kawahara-chou, Hakodate, Hokkaido, 041-8512, Japan.'}, {'ForeName': 'Katsuhiro', 'Initials': 'K', 'LastName': 'Mabe', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Hakodate National Hospital, 18-16, Kawahara-chou, Hakodate, Hokkaido, 041-8512, Japan.'}, {'ForeName': 'Naohiko', 'Initials': 'N', 'LastName': 'Harada', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}]",Journal of gastroenterology,['10.1007/s00535-022-01850-2']
1768,35073499,Pilot Social Network Weight Loss Intervention With Two Immigrant Populations During the COVID-19 Pandemic.,"PURPOSE


To examine the feasibility and acceptability of a social network weight loss intervention delivered by lay health promoters (HPs) to immigrant populations.
DESIGN


Single-arm, non-randomized, pilot study of a social network weight loss intervention developed by a community-based participatory research partnership and delivered by HPs.
SETTING


Community-based setting in Southeastern Minnesota, United States.
SAMPLE


Somali and Hispanic immigrants to the United States: 4 social networks of adults (2 Hispanic and 2 Somali) with 39 network participants.
INTERVENTION


Twelve-week behavioral weight loss intervention delivered by HPs (4 weeks in-person and then 8 weeks virtual).
MEASURES


Feasibility was assessed by recruitment and retention rates. Acceptability was assessed by surveys and focus groups with HPs and participants. Behavioral measures included servings of fruits and vegetables, drinking soda, and physical activity. Physiologic measures included weight, blood pressure, glucose, cholesterol, and triglycerides.
ANALYSIS


Paired t-tests of pre- to post-intervention changes at the end of 12 weeks of treatment.
RESULTS


Recruitment was feasible and post-intervention was 100%. Participants highly rated the intervention on satisfaction, motivation, and confidence to eat a healthy diet, be physically active, and lose weight. Participants were motivated by group social support and cohesion of their social networks. On average, participants lost weight (91.6 ± 15.9 to 89.7 ± 16.6 kg, P < .0001), lowered their systolic blood pressure (133.9±16.9 to 127.2 ± 15.8 mm Hg; P < .001), lowered their diastolic blood pressure (81 ± 9.5 to 75.8 ± 9.6 mm Hg; P < .0001), had more servings of vegetables per day (1.9 ± 1.2 to 2.6 ± 1.4; P < .001), and increased their physical activity (2690 ± 3231 to 6595 ± 7322 MET-minutes per week; P = .02).
CONCLUSION


This pilot study of 2 immigrant communities who participated in a peer-led weight loss social network intervention delivered during the COVID-19 pandemic demonstrated high feasibility and acceptability. Participants lost weight, improved their health status, and improved their health behaviors.",2022,"On average, participants lost weight (91.6 ± 15.9 to 89.7 ± 16.6 kg, P < .0001), lowered their systolic blood pressure (133.9±16.9 to 127.2 ± 15.8 mm Hg; P < .001), lowered their diastolic blood pressure (81 ± 9.5 to 75.8 ± 9.6 mm Hg; P < .0001), had more servings of vegetables per day (1.9 ± 1.2 to 2.6 ± 1.4; P < .001), and increased their physical activity (2690 ± 3231 to 6595 ± 7322 MET-minutes per week; P = .02).
","['Two Immigrant Populations During the COVID-19 Pandemic', 'immigrant populations', '2 immigrant communities who participated in a peer-led weight loss social network intervention delivered during the COVID-19 pandemic demonstrated high feasibility and acceptability', 'adults (2 Hispanic and 2 Somali) with 39 network participants', 'Community-based setting in Southeastern Minnesota, United States']","['Twelve-week behavioral weight loss intervention delivered by HPs', 'social network weight loss intervention delivered by lay health promoters (HPs', 'social network weight loss intervention developed by a community-based participatory research partnership and delivered by HPs', 'Pilot Social Network Weight Loss Intervention']","['physical activity', 'servings of fruits and vegetables, drinking soda, and physical activity', 'Participants lost weight, improved their health status, and improved their health behaviors', 'diastolic blood pressure', 'recruitment and retention rates', 'systolic blood pressure', 'satisfaction, motivation, and confidence to eat a healthy diet, be physically active, and lose weight', 'Acceptability', 'weight, blood pressure, glucose, cholesterol, and triglycerides']","[{'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0337847', 'cui_str': 'Somalis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C2350575', 'cui_str': 'Community-Based Participatory Research'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0683086', 'cui_str': 'Caffeinated soft drinks'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.0506635,"On average, participants lost weight (91.6 ± 15.9 to 89.7 ± 16.6 kg, P < .0001), lowered their systolic blood pressure (133.9±16.9 to 127.2 ± 15.8 mm Hg; P < .001), lowered their diastolic blood pressure (81 ± 9.5 to 75.8 ± 9.6 mm Hg; P < .0001), had more servings of vegetables per day (1.9 ± 1.2 to 2.6 ± 1.4; P < .001), and increased their physical activity (2690 ± 3231 to 6595 ± 7322 MET-minutes per week; P = .02).
","[{'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Wieland', 'Affiliation': 'Division of Community Internal Medicine, 4352Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Njeru', 'Affiliation': 'Division of Community Internal Medicine, 4352Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Gladys B', 'Initials': 'GB', 'LastName': 'Asiedu', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, 4352Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Zeratsky', 'Affiliation': 'Division of Endocrinology, Department of Nutrition, 4352Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': 'Department of Psychiatry and Psychology, 4352Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Goetze', 'Affiliation': 'Department of Psychiatry and Psychology, 4352Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Christi A', 'Initials': 'CA', 'LastName': 'Patten', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, 4352Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Sydney S', 'Initials': 'SS', 'LastName': 'Kelpin', 'Affiliation': 'Department of Psychiatry and Psychology, 4352Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novotny', 'Affiliation': 'Health Sciences Research, Biomedical Statistics and Informatics, 4352Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kiley', 'Initials': 'K', 'LastName': 'Lantz', 'Affiliation': 'Division of Infectious Diseases, 4352Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Yahye', 'Initials': 'Y', 'LastName': 'Ahmed', 'Affiliation': 'Somali American Social Services Association, Rochester, MN, USA.'}, {'ForeName': 'Luz', 'Initials': 'L', 'LastName': 'Molina', 'Affiliation': 'Language Services, 4352Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Graciela', 'Initials': 'G', 'LastName': 'Porraz Capetillo', 'Affiliation': 'Language Services, 4352Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Osman', 'Affiliation': 'Intercultural Mutual Assistance Association, Rochester, MN, USA.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Goodson', 'Affiliation': 'Alliance of Chicanos, Hispanics and Latin Americans, Rochester, MN, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Sia', 'Affiliation': 'Division of Infectious Diseases, 4352Mayo Clinic, Rochester, MN, USA.'}]",American journal of health promotion : AJHP,['10.1177/08901171211053450']
1769,35063791,"The association between biomass fuel use for cooking and linear growth in young children in Bhaktapur, Nepal.","BACKGROUND


There are still many people in the world who prepare their meals on open fires or stoves using solid fuels from biomass, especially in low-and middle-income countries. Although biomass cooking fuels have been associated with adverse health impacts and diseases, the association with child linear growth remains unclear.
OBJECTIVES


In a cohort design, we aimed to describe the association between the use of biomass cooking fuels and linear growth in children aged 18-23 months living in the urban and peri-urban community of Bhaktapur, situated in the Kathmandu valley in Nepal.
METHODS


Caretakers of 600 marginally stunted children aged 6-11 months were interviewed about their source of cooking fuel and other socio-demographic characteristics at enrolment into a randomized controlled trial. Children's body length was measured when children were 18-23 months old. In linear regression models, we estimated the association between the use of biomass fuel and length-for-age Z-scores (LAZ), adjusted for relevant confounders. We repeated these analyses in pre-defined sub-groups and different percentiles of LAZ using quantile regression models.
RESULTS


Among study participants, 101 (18%) used biomass as cooking fuel. The association between biomass fuel and LAZ was not statistically significant in the full sample (adjusted regression coefficient: -0.14, 95% CI: -0.28, 0.00). The association was stronger in some of the sub-groups and in the lower tail of the LAZ distribution (those who are stunted), but neither reached statistical significance.
DISCUSSION


Children from households in poor, urban neighborhoods in Nepal which used biomass fuel for cooking were on average slightly shorter than other children, although the association only approached statistical significance. As this was an observational study, residual confounding cannot be excluded. Further studies are needed to confirm these associations, in particular those seen in certain sub-groups.",2022,The association between biomass fuel and LAZ was not statistically significant in the full sample (adjusted regression coefficient:,"['children aged 18-23\xa0months living in the urban and peri-urban community of Bhaktapur, situated in the Kathmandu valley in Nepal', 'young children in Bhaktapur, Nepal', 'Caretakers of 600 marginally stunted children aged 6-11\xa0months']",['biomass cooking fuels and linear growth'],"[""Children's body length""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0335350', 'cui_str': 'Building caretaker'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}]","[{'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0221097', 'cui_str': 'Length of body'}]",,0.0494807,The association between biomass fuel and LAZ was not statistically significant in the full sample (adjusted regression coefficient:,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Schwinger', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health, Centre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway. Electronic address: c.schwinger@uib.no.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kvestad', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, NORCE Norwegian Research Centre, Bergen, Norway; Department of Research, Innlandet Hospital Trust, Lillehammer, Norway.'}, {'ForeName': 'Ram K', 'Initials': 'RK', 'LastName': 'Chandyo', 'Affiliation': 'Department of Community Medicine, Kathmandu Medical College, Kathmandu, Nepal.'}, {'ForeName': 'Manjeswori', 'Initials': 'M', 'LastName': 'Ulak', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health, Centre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway; Department of Child Health, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.'}, {'ForeName': 'Merina', 'Initials': 'M', 'LastName': 'Shrestha', 'Affiliation': 'Department of Child Health, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Ranjitkar', 'Affiliation': 'Department of Child Health, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.'}, {'ForeName': 'Tor A', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health, Centre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway; Department of Research, Innlandet Hospital Trust, Lillehammer, Norway. Electronic address: tor.strand@uib.no.'}]",Environment international,['10.1016/j.envint.2022.107089']
1770,35092599,Pharmacist-Led Management Improves Treatment Adherence and Quality of Life in Opioid-Tolerant Patients With Cancer Pain: A Randomized Controlled Trial.,"INTRODUCTION


Opioid-tolerant patients are more likely to deviate from recommended treatments and to experience inadequate analgesia than opioid-naive ones. The aim of this study was to examine whether pharmacist-led management could help improve treatment adherence and quality of life.
METHODS


Eligible patients were randomized in a 1:1 ratio to control group and intervention group. The control group received routine education and support, while the intervention group received additional individualized pharmacist-led care. The primary endpoint was treatment adherence in the per-protocol analysis, as evaluated by blinded assessors. An interim analysis was planned when 30% patients completed the study. Alpha was divided into the interim analysis (0.015) and the final analysis (0.035).
RESULTS


In the interim analysis (97 and 87 patients in the control and intervention groups, respectively), the primary endpoint was met. Pharmacist-led intervention significantly increased treatment adherence (93.3 vs. 79.8%; OR: 2.25; 95% CI 1.02, 4.94; P = 0.013), quality of life (0.81 ± 0.17 vs. 0.72 ± 0.25; P = 0.008), and reporting of adverse events (82.7 vs. 61.9%; OR: 1.88; 95% CI 1.16, 3.07; P = 0.004). The two groups did not differ in pain control rate (66.7 vs. 57.1%; OR: 1.25; 95% CI 0.87, 1.78; P = 0.218), breakthrough pain-free rate (66.7 vs. 61.9%; OR: 1.12; 95% CI 0.78, 1.59; P = 0.532) and pain score (1.97 ± 1.04 vs. 2.15 ± 1.24; P = 0.522).
CONCLUSIONS


Pharmacist-led management improved treatment adherence, quality of life, and the reporting of adverse events in opioid-tolerant patients with cancer pain.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03455023.",2022,"Pharmacist-led intervention significantly increased treatment adherence (93.3 vs. 79.8%; OR: 2.25; 95% CI 1.02, 4.94; P = 0.013), quality of life (0.81 ± 0.17 vs. 0.72 ± 0.25; P = 0.008), and reporting of adverse events (82.7 vs. 61.9%;","['Eligible patients', 'opioid-tolerant patients with cancer pain', 'Opioid-Tolerant Patients With Cancer Pain']","['Pharmacist-Led Management', 'routine education and support, while the intervention group received additional individualized pharmacist-led care']","['pain control rate', 'treatment adherence and quality of life', 'treatment adherence in the per-protocol analysis', 'treatment adherence, quality of life', 'pain score', 'reporting of adverse events', 'breakthrough pain-free rate', 'Adherence and Quality of Life', 'quality of life', 'treatment adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1135120', 'cui_str': 'Breakthrough pain'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.166546,"Pharmacist-led intervention significantly increased treatment adherence (93.3 vs. 79.8%; OR: 2.25; 95% CI 1.02, 4.94; P = 0.013), quality of life (0.81 ± 0.17 vs. 0.72 ± 0.25; P = 0.008), and reporting of adverse events (82.7 vs. 61.9%;","[{'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Pharmacy, Cancer Hospital of University of Chinese Academy of Sciences, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Department of Pharmacy, Cancer Hospital of University of Chinese Academy of Sciences, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.'}, {'ForeName': 'Silu', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Department of Pharmacy, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, 42 Baiziting Road, Nanjing, 210009, China.'}, {'ForeName': 'Ruixiang', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': 'Department of Pharmacy, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, 350014, China.'}, {'ForeName': 'Yuguo', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Pharmacy, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, 250117, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhai', 'Affiliation': 'Department of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.'}, {'ForeName': 'Luo', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'Department of Pharmacy, Cancer Hospital of University of Chinese Academy of Sciences, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.'}, {'ForeName': 'Yinghui', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': 'Department of Pharmacy, Cancer Hospital of University of Chinese Academy of Sciences, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Pharmacy, Cancer Hospital of University of Chinese Academy of Sciences, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.'}, {'ForeName': 'Wenxiu', 'Initials': 'W', 'LastName': 'Xin', 'Affiliation': 'Department of Pharmacy, Cancer Hospital of University of Chinese Academy of Sciences, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'Department of Pharmacy, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, 42 Baiziting Road, Nanjing, 210009, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, 350014, China.'}, {'ForeName': 'Wenna', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Department of Pharmacy, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, 250117, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Pharmacy, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, 350014, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, 250117, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Shao', 'Affiliation': 'Department of Pharmacy, Division of Life Sciences and Medicine, The First Affiliated Hospital of University of Science and Technology of China, Hefei, 230031, China.'}, {'ForeName': 'Yangkui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacy, Division of Life Sciences and Medicine, The First Affiliated Hospital of University of Science and Technology of China, Hefei, 230031, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Pharmacy, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, 350014, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Division of Life Sciences and Medicine, The First Affiliated Hospital of University of Science and Technology of China, Hefei, 230031, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Du', 'Affiliation': 'Department of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.'}, {'ForeName': 'Yezi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.'}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Division of Life Sciences and Medicine, The First Affiliated Hospital of University of Science and Technology of China, Hefei, 230031, China.'}, {'ForeName': 'Cunxian', 'Initials': 'C', 'LastName': 'Duan', 'Affiliation': 'Department of Pharmacy, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, 250117, China.'}, {'ForeName': 'Qiulin', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmacy, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, 350014, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Pharmacy, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, 250117, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Pharmacy, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, 350014, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': 'Department of Pharmacy, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, 250117, China.'}, {'ForeName': 'Huawei', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Pharmacy, Division of Life Sciences and Medicine, The First Affiliated Hospital of University of Science and Technology of China, Hefei, 230031, China.'}, {'ForeName': 'Lingya', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Cancer Hospital of University of Chinese Academy of Sciences, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.'}, {'ForeName': 'Sisi', 'Initials': 'S', 'LastName': 'Kong', 'Affiliation': 'Department of Pharmacy, Cancer Hospital of University of Chinese Academy of Sciences, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Division of Life Sciences and Medicine, The First Affiliated Hospital of University of Science and Technology of China, Hefei, 230031, China.'}, {'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'Gong', 'Affiliation': 'Department of Rare Cancer and Head and Neck Medical Oncology, Cancer Hospital of University of Chinese Academy of Sciences, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Medical Oncology, Cancer Hospital of University of Chinese Academy of Sciences, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.'}, {'ForeName': 'Zhengbo', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Clinical Trial, Cancer Hospital of University of Chinese Academy of Sciences, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Pain Management, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, 210009, China.'}, {'ForeName': 'Shoubing', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Medical Oncology, Division of Life Sciences and Medicine, The First Affiliated Hospital of University of Science and Technology of China, Hefei, 230031, China.'}, {'ForeName': 'Chengsuo', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, 250117, China.'}, {'ForeName': 'Jinyuan', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Abdominal Oncology, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, 350014, China.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Xianhong', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Health Service Management, Medical College of Hangzhou Normal University, Hangzhou, 310022, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Pharmacy, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, 42 Baiziting Road, Nanjing, 210009, China. jsschwq@sina.com.'}, {'ForeName': 'Yancai', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Pharmacy, Division of Life Sciences and Medicine, The First Affiliated Hospital of University of Science and Technology of China, Hefei, 230031, China. 13349293359@163.com.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Department of Pharmacy, Cancer Hospital of University of Chinese Academy of Sciences, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China. huangping1841@zjcc.org.cn.'}]",Pain and therapy,['10.1007/s40122-021-00342-0']
1771,35092305,OX40L Inhibition Suppresses KLH-driven Immune Responses in Healthy Volunteers: A Randomized Controlled Trial Demonstrating Proof-of-Pharmacology for KY1005.,"The safety, tolerability, immunogenicity, and pharmacokinetic (PK) profile of an anti-OX40L monoclonal antibody (KY1005, currently amlitelimab) were evaluated. Pharmacodynamic (PD) effects were explored using keyhole limpet hemocyanin (KLH) and tetanus toxoid (TT) immunizations. Sixty-four healthy male subjects (26.5 ± 6.0 years) were randomized to single doses of 0.006, 0.018, or 0.05 mg/kg, or multiple doses of 0.15, 0.45, 1.35, 4, or 12 mg/kg KY1005, or placebo (6:2). Serum KY1005 concentrations were measured. Antibody responses upon KLH and TT immunizations and skin response upon intradermal KLH administration were performed. PD data were analyzed using repeated measures analysis of covariances (ANCOVAs) and post hoc exposure-response modeling. No serious adverse events occurred and all adverse events were temporary and of mild or moderate severity. A nonlinear increase in mean serum KY1005 concentrations was observed (median time to maximum concentration (T max  ) ~ 4 hours, geometric mean terminal half-life (t½) ~ 24 days). Cutaneous blood perfusion (estimated difference (ED) -13.4 arbitrary unit (AU), 95% confidence interval (CI) -23.0 AU to -3.8 AU) and erythema quantified as average redness (ED -0.23 AU, 95% CI -0.35 AU to -0.11 AU) decreased after KY1005 treatment at doses of 0.45 mg/kg and above. Exposure-response analysis displayed a statistically significant treatment effect on anti-KLH antibody titers (IgG maximum effect (E max  ) -0.58 AU, 95% CI -1.10 AU to -0.06 AU) and skin response (erythema E max  -0.20 AU, 95% CI -0.29 AU to -0.11 AU). Administration of KY1005 demonstrated an acceptable safety and tolerability profile and PK analyses displayed a nonlinear profile of KY1005. Despite the observed variability, skin challenge response after KY1005 treatment indicated pharmacological activity of KY1005. Therefore, KY1005 shows potential as a novel pharmacological treatment in immune-mediated disorders.",2022,"Cutaneous blood perfusion (estimated difference (ED) -13.4 arbitrary unit (AU), 95% CI -23.0 AU - -3.8 AU) and erythema quantified as average redness (ED -0.23 AU, 95% CI -0.35","['Sixty-four healthy male subjects (26.5±6.0 years', 'Healthy Volunteers']","['placebo', 'keyhole limpet haemocyanin (KLH) and tetanus toxoid (TT) immunizations', 'OX40L Inhibition Suppresses KLH']","['Cutaneous blood perfusion', 'safety, tolerability, immunogenicity and pharmacokinetic (PK) profile', 'mean serum KY1005 concentrations', 'anti-KLH antibody titres (IgG Emax', 'acceptable safety and tolerability profile and PK analyses', 'Pharmacodynamic (PD) effects', 'Antibody responses upon KLH and TT immunizations and skin response', 'Serum KY1005 concentrations', 'skin response', 'serious adverse events', 'erythema quantified as average redness']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0064332', 'cui_str': 'Keyhole-limpet hemocyanin'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0257572', 'cui_str': 'TNFSF4 protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}]","[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0064332', 'cui_str': 'Keyhole-limpet hemocyanin'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",64.0,0.0422152,"Cutaneous blood perfusion (estimated difference (ED) -13.4 arbitrary unit (AU), 95% CI -23.0 AU - -3.8 AU) and erythema quantified as average redness (ED -0.23 AU, 95% CI -0.35","[{'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Saghari', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Gal', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Gilbert', 'Affiliation': 'Kymab Ltd., Cambridge, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Yateman', 'Affiliation': 'Kymab Ltd., Cambridge, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Porter-Brown', 'Affiliation': 'Kymab Ltd., Cambridge, UK.'}, {'ForeName': 'Nuala', 'Initials': 'N', 'LastName': 'Brennan', 'Affiliation': 'Kymab Ltd., Cambridge, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Quaratino', 'Affiliation': 'Kymab Ltd., Cambridge, UK.'}, {'ForeName': 'Rosamund', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': 'Kymab Ltd., Cambridge, UK.'}, {'ForeName': 'Hendrika W', 'Initials': 'HW', 'LastName': 'Grievink', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Erica S', 'Initials': 'ES', 'LastName': 'Klaassen', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Kirsten R', 'Initials': 'KR', 'LastName': 'Bergmann', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Martijn B A', 'Initials': 'MBA', 'LastName': 'van Doorn', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'Kymab Ltd., Cambridge, UK.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Moerland', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rissmann', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2539']
1772,35081915,Comparing methods of adenosine administration in paroxysmal supraventricular tachycardia: a pilot randomized controlled trial.,"BACKGROUND


Intravenous adenosine is the recommended treatment for paroxysmal supraventricular tachycardia (PSVT). There is no official recommended method of giving adenosine. We compared the success rates between a standard and alternative method of first dose intravenous adenosine in PSVT.
METHODS


A pilot parallel randomized controlled study was conducted in the emergency department of a tertiary care hospital. Eligible patients were stable PSVT adult patients. We used block randomization and divided them into two groups, the standard method (double syringe technique of 6 mg of adenosine), and the alternative method (similar to the standard method, then immediately followed by elevating the arm to 90° perpendicular to a horizontal plane for 10 s). The primary outcome was the success rate of electrocardiogram (ECG) response which demonstrated termination of PSVT (at least two-fold of the RR-interval widening or sinus rhythm conversion). Secondary outcomes were complications within one minute after the injection.
RESULTS


We allocated 15 patients in each group and analyzed them as intention-to-treat. The success rate was 86.7% in the alternative group and 80% in the standard group (risk difference 6.7%, 95% confidence interval - 19.9 to 33.2%, P 1.00). Complications within one minute after adenosine injection were also similar in both groups, 14 of 15 patients (93%) in each group had no complications, without significant difference.
CONCLUSIONS


No evidence of the difference between alternative and standard methods occurred, in terms of the success rate of ECG response and complications within one minute after adenosine injection. The standard method of adenosine injection is a safe, easy-to-administer, and widely available treatment for PSVT.
TRIAL REGISTRATION


TCTR20200609001.",2022,"No evidence of the difference between alternative and standard methods occurred, in terms of the success rate of ECG response and complications within one minute after adenosine injection.","['Eligible patients were stable PSVT adult patients', 'emergency department of a tertiary care hospital', 'paroxysmal supraventricular tachycardia (PSVT', 'paroxysmal supraventricular tachycardia']","['adenosine injection', 'standard method (double syringe technique of 6\xa0mg of adenosine', 'adenosine', 'adenosine administration']","['success rates', 'complications within one minute after the injection', 'success rate', 'Complications', 'success rate of electrocardiogram (ECG) response which demonstrated termination of PSVT (at least two-fold of the RR-interval widening or sinus rhythm conversion', 'success rate of ECG response and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030590', 'cui_str': 'Paroxysmal supraventricular tachycardia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C4019274', 'cui_str': 'Adenosine Injection'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0030590', 'cui_str': 'Paroxysmal supraventricular tachycardia'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",15.0,0.102003,"No evidence of the difference between alternative and standard methods occurred, in terms of the success rate of ECG response and complications within one minute after adenosine injection.","[{'ForeName': 'Phruek', 'Initials': 'P', 'LastName': 'Daengbubpha', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Chiang Mai University, 110 Inthawaroros Road, Sribhumi, Amphoe Muang Chiang Mai, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Borwon', 'Initials': 'B', 'LastName': 'Wittayachamnankul', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Chiang Mai University, 110 Inthawaroros Road, Sribhumi, Amphoe Muang Chiang Mai, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Krongkarn', 'Initials': 'K', 'LastName': 'Sutham', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Chiang Mai University, 110 Inthawaroros Road, Sribhumi, Amphoe Muang Chiang Mai, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Boriboon', 'Initials': 'B', 'LastName': 'Chenthanakij', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Chiang Mai University, 110 Inthawaroros Road, Sribhumi, Amphoe Muang Chiang Mai, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Theerapon', 'Initials': 'T', 'LastName': 'Tangsuwanaruk', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Chiang Mai University, 110 Inthawaroros Road, Sribhumi, Amphoe Muang Chiang Mai, Chiang Mai, 50200, Thailand. theerapon.t@cmu.ac.th.'}]",BMC cardiovascular disorders,['10.1186/s12872-022-02464-5']
1773,35108114,A pilot economic evaluation of a feasibility trial for SUpporting wellbeing through PEeR-Befriending (SUPERB) for post-stroke aphasia.,"OBJECTIVES


To explore the feasibility of a full economic evaluation of usual care plus peer-befriending versus usual care control, and potential cost-effectiveness of peer-befriending for people with aphasia. To report initial costs, ease of instruments' completion and overall data completeness.
DESIGN


Pilot economic evaluation within a feasibility randomised controlled trial.
SETTING


Community, England.
PARTICIPANTS


People with post-stroke aphasia and low levels of psychological distress.
INTERVENTION


All participants received usual care; intervention participants received six peer-befriending visits between randomisation and four months.
MAIN MEASURES


Costs were collected on the stroke-adapted Client Service Receipt Inventory (CSRI) for health, social care and personal out-of-pocket expenditure arising from care for participants and carers at 4- and 10-months post-randomisation. Health gains and costs were reported using the General Health Questionnaire-12 and the EQ-5D-5L. Mean (CI) differences for costs and health gains were reported and uncertainty represented using non-parametric bootstrapping and cost-effectiveness acceptability curves.
RESULTS


56 participants were randomised. Mean age was 70.1 (SD 13.4). Most ( n  = 37, 66%) had mild and many ( n  = 14; 25%) severe aphasia. There was ≥94% completion of CSRI questions. Peer-befriending was higher in intervention arm ( p  < 0.01) but there were no significant differences in total costs between trial arms. Peer-befriending visits costed on average £57.24 (including training and supervision costs). The probability of peer-befriending being cost-effective ranged 39% to 66%.
CONCLUSIONS


Economic data can be collected from participants with post-stroke aphasia, indicating a full economic evaluation within a definitive trial is feasible. A larger study is needed to demonstrate further cost-effectiveness of peer-befriending.",2022,Peer-befriending was higher in intervention arm ( p  < 0.01) but there were no significant differences in total costs between trial arms.,"['Community, England', 'People with post-stroke aphasia and low levels of psychological distress', 'people with aphasia', '56 participants were randomised']","['EQ-5D-5L', 'usual care; intervention participants received six peer-befriending visits between randomisation and four months', 'PEeR-Befriending (SUPERB', 'peer-befriending', 'usual care plus peer-befriending versus usual care control']","['stroke-adapted Client Service Receipt Inventory (CSRI) for health, social care and personal out-of-pocket expenditure arising from care', 'severe aphasia', 'Mean (CI) differences for costs and health gains', 'Peer-befriending', 'probability of peer-befriending being cost-effective', 'total costs']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C3815933', 'cui_str': 'Uninsured medical expenses'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",56.0,0.0600499,Peer-befriending was higher in intervention arm ( p  < 0.01) but there were no significant differences in total costs between trial arms.,"[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Flood', 'Affiliation': 'School of Health and Social Care, 4914London South Bank University, London, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Behn', 'Affiliation': 'Centre for Language and Communication Sciences Research, School of Health Sciences, City, University of London, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Centre for Language and Communication Sciences Research, School of Health Sciences, City, University of London, London, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': 'Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, Kings College London, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Northcott', 'Affiliation': 'Centre for Language and Communication Sciences Research, School of Health Sciences, City, University of London, London, UK.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Division of Rehabilitation & Ageing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Goldsmith', 'Affiliation': ""King's Clinical Trials Unit, Kings College London, London, UK.""}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'McVicker', 'Affiliation': 'Centre for Language and Communication Sciences Research, School of Health Sciences, City, University of London, London, UK.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Jofre-Bonet', 'Affiliation': 'Office of Health Economics4616, London, UK.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Hilari', 'Affiliation': 'Centre for Language and Communication Sciences Research, School of Health Sciences, City, University of London, London, UK.'}]",Clinical rehabilitation,['10.1177/02692155211063554']
1774,35093561,Anodic and symmetric biphasic pulses enlarge the therapeutic window in deep brain stimulation for essential tremor.,"BACKGROUND


Since the inception of DBS, cathodic pulses have been used.
OBJECTIVE


To investigate the effect of anodic and symmetric biphasic pulses on the therapeutic window (TW) in essential tremor (ET) patients.
METHODS


A randomized, doubled-blinded, cross-over design was used to test the effect of cathodic, anodic and symmetric biphasic pulses (cathode-first and anode-first) on the TW in an acute clinical setting. TW was defined as the difference between the minimal stimulation amplitude provoking side effects and minimal stimulation amplitude inducing tremor arrest.
RESULTS


9 ET patients (10 hemispheres) were included. Anodic stimulation induced a significantly larger TW compared to cathodic stimulation (p = 0.008). Symmetric biphasic stimulation also widened the TW compared to cathodic stimulation for both cathode- (p = 0.047) and anode-first (p = 0.008) biphasic pulses. For both anodic and biphasic pulses, the effect on TW was mainly driven by the change in side effect threshold. The order of the phases in the biphasic pulse had a significant effect on the side effect threshold (p = 0.039), with biphasic-anode first having the highest value. All pulse shapes were safe in the acute setting.
CONCLUSION


Anodic and symmetric biphasic pulses increase TW in ET patients.",2022,Symmetric biphasic stimulation also widened TW compared to cathodic stimulation for both cathode- (p = 0.047) and anode-first (p = 0.008) biphasic pulses.,"['9\u202fET patients (10 hemispheres) were included', 'essential tremor (ET) patients', 'ET patients']","['anodic and symmetric biphasic pulses', 'cathodic, anodic and symmetric biphasic pulses (cathode-first and anode-first']",['Symmetric biphasic stimulation'],"[{'cui': 'C0270736', 'cui_str': 'Essential tremor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0007441', 'cui_str': 'Cathode'}, {'cui': 'C0003103', 'cui_str': 'Anode'}]","[{'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",,0.0308591,Symmetric biphasic stimulation also widened TW compared to cathodic stimulation for both cathode- (p = 0.047) and anode-first (p = 0.008) biphasic pulses.,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Boogers', 'Affiliation': 'Experimental ORL, Department of Neurosciences, The Leuven Brain Institute, KU Leuven, Herestraat 49, 3000, Leuven, Belgium; Department of Neurology, UZ Leuven, Herestraat 49, 3000, Leuven, Belgium. Electronic address: alexandra.boogers@kuleuven.be.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Peeters', 'Affiliation': 'Experimental ORL, Department of Neurosciences, The Leuven Brain Institute, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Van Bogaert', 'Affiliation': 'Experimental ORL, Department of Neurosciences, The Leuven Brain Institute, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Boateng', 'Initials': 'B', 'LastName': 'Asamoah', 'Affiliation': 'Experimental ORL, Department of Neurosciences, The Leuven Brain Institute, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'De Vloo', 'Affiliation': 'Department of Neurosurgery, UZ Leuven, Herestraat 49, 3000, Leuven, Belgium; Experimental Neurosurgery and Neuroanatomy, Department of Neurosciences, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Vandenberghe', 'Affiliation': 'Department of Neurology, UZ Leuven, Herestraat 49, 3000, Leuven, Belgium; Laboratory for Parkinson Research, Department of Neurosciences, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Nuttin', 'Affiliation': 'Department of Neurosurgery, UZ Leuven, Herestraat 49, 3000, Leuven, Belgium; Experimental Neurosurgery and Neuroanatomy, Department of Neurosciences, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Mc Laughlin', 'Affiliation': 'Experimental ORL, Department of Neurosciences, The Leuven Brain Institute, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.'}]",Brain stimulation,['10.1016/j.brs.2022.01.012']
1775,35093842,Emotional processing intervention (EMOPRINT): A blinded randomized control trial to treat facial affect recognition deficits in multiple sclerosis.,"OBJECTIVE


Facial affect recognition deficits have been noted in persons with MS, however there is no treatment for these impairments. We investigated the efficacy of the Emotional Processing Intervention (EMOPRINT), a 12-session behavioral intervention teaching facial affect recognition skills and mimicry to improve facial affect recognition abilities in persons with MS.
METHODS


This double blind, placebo-controlled, randomized clinical trial with two time points (pre-treatment; post-treatment) included 36 participants with clinically definite MS, 21 in the treatment group and 15 in the placebo control group. Participants completed a pre-test and post-test neuropsychological assessment, which consisted of tasks of facial affect recognition (primary outcome measure) and questionnaires to assess quality of life and emotional functioning (secondary outcome measures). We hypothesized that improvements in facial affect recognition skills would be observed following treatment. We also examined changes to quality of life and social functioning. Changes in outcome measures were analyzed using a mixed-method analysis of variance.
RESULTS


The treatment group showed significantly improved facial affect recognition skills relative to the placebo group post-treatment, F(1,34)=5.91, p=.022, partial ꞃ 2 =0.146. No significant change was noted on secondary outcomes. The majority of the participants in the intervention group reported that the intervention was helpful and that they used the skills learned in their daily interactions.
CONCLUSION


EMOPRINT is effective for improving facial affect recognition skills in MS.",2022,"The treatment group showed significantly improved facial affect recognition skills relative to the placebo group post-treatment, F(1,34)=5.91, p=.022, partial ꞃ 2 =0.146.","['36 participants with clinically definite MS, 21 in the treatment group and 15 in the placebo control group', 'multiple sclerosis', 'persons with MS']","['placebo', 'Emotional Processing Intervention (EMOPRINT', 'Emotional processing intervention (EMOPRINT']","['quality of life and social functioning', 'facial affect recognition skills', 'quality of life and emotional functioning']","[{'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",36.0,0.214005,"The treatment group showed significantly improved facial affect recognition skills relative to the placebo group post-treatment, F(1,34)=5.91, p=.022, partial ꞃ 2 =0.146.","[{'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Genova', 'Affiliation': 'Kessler Foundation, 120 Eagle Rock Ave, Suite 100, East Hanover, New Jersey, USA; Rutgers New Jersey Medical School, 90 Bergen Street, Suite 3100, Newark, New Jersey, USA. Electronic address: hgenova@kesslerfoundation.org.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Lancaster', 'Affiliation': 'Kessler Foundation, 120 Eagle Rock Ave, Suite 100, East Hanover, New Jersey, USA; Rutgers New Jersey Medical School, 90 Bergen Street, Suite 3100, Newark, New Jersey, USA.'}, {'ForeName': 'Zuzanna', 'Initials': 'Z', 'LastName': 'Myszko', 'Affiliation': 'Kessler Foundation, 120 Eagle Rock Ave, Suite 100, East Hanover, New Jersey, USA.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Morecraft', 'Affiliation': 'Bristol Myers Squibb, 80 Morris Avenue, Summit, New Jersey, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Leddy', 'Affiliation': 'Kessler Foundation, 120 Eagle Rock Ave, Suite 100, East Hanover, New Jersey, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Kessler Foundation, 120 Eagle Rock Ave, Suite 100, East Hanover, New Jersey, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Chiaravalloti', 'Affiliation': 'Kessler Foundation, 120 Eagle Rock Ave, Suite 100, East Hanover, New Jersey, USA; Rutgers New Jersey Medical School, 90 Bergen Street, Suite 3100, Newark, New Jersey, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Lengenfelder', 'Affiliation': 'Kessler Foundation, 120 Eagle Rock Ave, Suite 100, East Hanover, New Jersey, USA; Rutgers New Jersey Medical School, 90 Bergen Street, Suite 3100, Newark, New Jersey, USA.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2022.103536']
1776,35103074,The Effect of Skin-to-Skin Contact on Postoperative Depression and Physical Recovery of Parturients after Cesarean Section in Obstetrics and Gynecology Department.,"The effect of skin-to-skin contact (SSC) on postpartum depression and physical rehabilitation of cesarean section women was explored. 280 parturients undergoing cesarean section were selected and were rolled into two groups randomly. The parturients in the control group (Con group, 140 cases) received routine care, and those in the experimental group (Exp group, 140 cases) received SSC on the basis of routine care. The postpartum depression and physical recovery of parturients in two groups were compared. It was found that, in the Exp group, the number of pregnant women with no or with very mild depression was much more 85% vs. 55%), the number of women with adequate lactation was more (53 cases vs. 27 cases), the first lactation time (FLT) was dramatically shorter (41.25 ± 4.81 h vs. 58.43 ± 5.43 h), the breastfeeding success rate (BFSR) and breastfeeding rate (BFR) were obvious higher, the days for uterine involution was much shorter (6.96 ± 1.13 days vs. 9.47 ± 1.75 days), the descent of uterine fundus 24 hours after delivery (24 h-DUF) was obviously larger (3.17 ± 0.26 mm vs. 1.56 ± 0.43 mm), the duration of lochia (DOL) was remarkably shorter (33.21 ± 5.32 days vs. 25.32 ± 3.54 days), and the  Visual Analogue Scale  (VAS) score was lower (4.88 ± 0.32 points vs. 3.41 ± 0.53 points), showing statistical differences for all above indicators ( P  < 0.05). It suggested that SSC could effectively relieve the postpartum depression of uterine parturients, promote the lactation, increase the BFR, facilitate uterine involution, and alleviate chronic uterine inflammation and postpartum pain, showing high clinical application and promotion value.",2022,"It was found that, in the Exp group, the number of pregnant women with no or with very mild depression was much more 85% vs. 55%), the number of women with adequate lactation was more (53 cases vs. 27 cases), the first lactation time (FLT) was dramatically shorter (41.25 ± 4.81 h vs. 58.43 ± 5.43 h), the breastfeeding success rate (BFSR) and breastfeeding rate (BFR) were obvious higher, the days for uterine involution was much shorter (6.96 ± 1.13 days vs. 9.47 ± 1.75 days), the descent of uterine fundus 24 hours after delivery (24 h-DUF) was obviously larger (3.17 ± 0.26 mm vs. 1.56 ± 0.43 mm), the duration of lochia (DOL) was remarkably shorter (33.21 ± 5.32 days vs. 25.32 ± 3.54 days), and the  Visual Analogue Scale  (VAS) score was lower (4.88 ± 0.32 points vs. 3.41 ± 0.53 points), showing statistical differences for all above indicators ( P  < 0.05).","['Parturients after Cesarean Section in Obstetrics and Gynecology Department', '280 parturients undergoing cesarean section', 'cesarean section women']","['Skin-to-Skin Contact', 'routine care', 'SSC', 'skin-to-skin contact (SSC']","['breastfeeding success rate (BFSR) and breastfeeding rate (BFR', 'Visual Analogue Scale  (VAS) score', 'Postoperative Depression and Physical Recovery', 'number of pregnant women with no or with very mild depression', 'postpartum depression and physical rehabilitation', 'duration of lochia (DOL', 'BFR, facilitate uterine involution, and alleviate chronic uterine inflammation and postpartum pain', 'number of women with adequate lactation', 'first lactation time (FLT', 'postpartum depression and physical recovery']","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0587480', 'cui_str': 'Obstetrics and gynecology department'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0362037', 'cui_str': 'Postoperative depression'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0588006', 'cui_str': 'Mild depression'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0227855', 'cui_str': 'Lochia'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0333953', 'cui_str': 'Involution'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235883', 'cui_str': 'Uterine inflammation'}, {'cui': 'C0848200', 'cui_str': 'Afterbirth pain'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206795', 'cui_str': 'alovudine'}]",280.0,0.0142939,"It was found that, in the Exp group, the number of pregnant women with no or with very mild depression was much more 85% vs. 55%), the number of women with adequate lactation was more (53 cases vs. 27 cases), the first lactation time (FLT) was dramatically shorter (41.25 ± 4.81 h vs. 58.43 ± 5.43 h), the breastfeeding success rate (BFSR) and breastfeeding rate (BFR) were obvious higher, the days for uterine involution was much shorter (6.96 ± 1.13 days vs. 9.47 ± 1.75 days), the descent of uterine fundus 24 hours after delivery (24 h-DUF) was obviously larger (3.17 ± 0.26 mm vs. 1.56 ± 0.43 mm), the duration of lochia (DOL) was remarkably shorter (33.21 ± 5.32 days vs. 25.32 ± 3.54 days), and the  Visual Analogue Scale  (VAS) score was lower (4.88 ± 0.32 points vs. 3.41 ± 0.53 points), showing statistical differences for all above indicators ( P  < 0.05).","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Operating Room, The Maternity & Children Care Hospital of Lishui City, Lishui, Zhejiang, 323000, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Operating Room, The Maternity & Children Care Hospital of Lishui City, Lishui, Zhejiang, 323000, China.'}, {'ForeName': 'Weijuan', 'Initials': 'W', 'LastName': 'Ye', 'Affiliation': 'Gynecological Ward, The Maternity & Children Care Hospital of Lishui City, Lishui, Zhejiang, 323000, China.'}, {'ForeName': 'Congxia', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Nursing Department, The Maternity & Children Care Hospital of Lishui City, Lishui, Zhejiang, 323000, China.'}]",Computational and mathematical methods in medicine,['10.1155/2022/9927805']
1777,35091184,Safety of pre- or postoperative accelerated radiotherapy in 5 fractions: A randomized pilot trial.,"OBJECTIVE


Neo-adjuvant radiotherapy (NART) for breast cancer has shown promising survival results in retrospective trials. However, there are some obstacles such as a chemotherapy delay, an increased overall treatment time (OTT) and the risk of increasing surgical morbidity. Accelerated radiotherapy (RT) in 5 fractions allows to deliver NART in a very short time span and minimizes the delay of surgery and chemotherapy. This trial investigates this NART schedule for safety, feasibility and OTT.
MATERIAL AND METHODS


Twenty patients eligible for neo-adjuvant chemotherapy (NACT) and breast conserving surgery, were randomized between NART before NACT or NACT and postoperative RT. In both arms, RT treatment was given in 5 fractions to the whole breast with a simultaneously integrated boost (SIB) on the tumor(bed). Lymph node irradiation was given concomitantly in case of lymph node involvement. OTT was defined as the time from diagnosis to last surgery in the intervention group, while in the control group the time between diagnosis and last RT-fraction was used. In the intervention group NACT-delay was defined as time between diagnosis and start of chemotherapy.
RESULTS


20 patients were included, and 19 patients completed treatment. OTT was significantly shorter in the intervention group (mean 218 days, range 196-253) compared to the control group (mean 237, range 211-268, p = 0.001). The difference in mean duration from diagnosis to the first treatment was a non-significant 4 days longer (31 vs 27 days, p = 0.28), but the start of NACT after diagnosis was delayed by 21 days (48 vs 27 days, p < 0.001). NART did not result in additional surgery complications.
CONCLUSION


This pilot trial is the first to report on accelerated NART in 5 fractions with SIB. NART before NACT resulted in a shorter OTT with good safety results.",2022,"OTT was significantly shorter in the intervention group (mean 218 days, range 196-253) compared to the control group (mean 237, range 211-268, p = 0.001).","['Twenty patients eligible for neo-adjuvant chemotherapy (NACT) and breast conserving surgery', '20 patients were included, and 19 patients completed treatment', '5 fractions']","['NART before NACT', 'NART before NACT or NACT and postoperative RT', 'pre- or postoperative accelerated radiotherapy', 'Neo-adjuvant radiotherapy (NART', 'Accelerated radiotherapy (RT', 'NART']","['overall treatment time (OTT) and the risk of increasing surgical morbidity', 'OTT', 'mean duration from diagnosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",20.0,0.0240252,"OTT was significantly shorter in the intervention group (mean 218 days, range 196-253) compared to the control group (mean 237, range 211-268, p = 0.001).","[{'ForeName': 'Vakaet', 'Initials': 'V', 'LastName': 'Vincent', 'Affiliation': 'Dept. of Human Structure and Repair, Ghent University, Belgium; Dept. of Radiation Oncology, Ghent University Hospital, Belgium. Electronic address: vincent.vakaet@ugent.be.'}, {'ForeName': 'Van Hulle', 'Initials': 'VH', 'LastName': 'Hans', 'Affiliation': 'Dept. of Human Structure and Repair, Ghent University, Belgium. Electronic address: hans.vanhulle@ugent.be.'}, {'ForeName': 'Van de Vijver', 'Initials': 'VV', 'LastName': 'Koen', 'Affiliation': 'Dept. of Pathology, Ghent University Hospital, Belgium; Dept. of Diagnostic Sciences, Ghent University, Belgium. Electronic address: koen.vandevijver@ugent.be.'}, {'ForeName': 'Hilderson', 'Initials': 'H', 'LastName': 'Ingeborg', 'Affiliation': 'Dept. of Medical Oncology, Ghent University Hospital, Belgium. Electronic address: ingeborg.hilderson@uzgent.be.'}, {'ForeName': 'Naert', 'Initials': 'N', 'LastName': 'Eline', 'Affiliation': 'Dept. of Medical Oncology, Ghent University Hospital, Belgium; Dept. of Internal Medicine and Pediatrics, Ghent University, Belgium. Electronic address: eline.naert@uzgent.be.'}, {'ForeName': 'De Neve', 'Initials': 'N', 'LastName': 'Wilfried', 'Affiliation': 'Dept. of Human Structure and Repair, Ghent University, Belgium. Electronic address: wilfried.deneve@ugent.be.'}, {'ForeName': 'Vandorpe', 'Initials': 'V', 'LastName': 'Jo', 'Affiliation': 'Dept. of Pathology, Ghent University Hospital, Belgium; Dept. of Diagnostic Sciences, Ghent University, Belgium. Electronic address: jo.vandorpe@ugent.be.'}, {'ForeName': 'Hendrix', 'Initials': 'H', 'LastName': 'An', 'Affiliation': 'Dept. of Human Structure and Repair, Ghent University, Belgium. Electronic address: an.hendrix@ugent.be.'}, {'ForeName': 'Göker', 'Initials': 'G', 'LastName': 'Menekse', 'Affiliation': 'Dept. of Gynaecology, Ghent University Hospital, Belgium. Electronic address: menekse.goker@uzgent.be.'}, {'ForeName': 'Depypere', 'Initials': 'D', 'LastName': 'Herman', 'Affiliation': 'Dept. of Human Structure and Repair, Ghent University, Belgium; Dept. of Gynaecology, Ghent University Hospital, Belgium. Electronic address: herman.depypere@ugent.be.'}, {'ForeName': 'Vergauwen', 'Initials': 'V', 'LastName': 'Glenn', 'Affiliation': 'Dept. of Gynaecology, Ghent University Hospital, Belgium. Electronic address: glenn.vergauwen@uzgent.be.'}, {'ForeName': 'Van den Broecke', 'Initials': 'VDB', 'LastName': 'Rudy', 'Affiliation': 'Dept. of Human Structure and Repair, Ghent University, Belgium; Dept. of Gynaecology, Ghent University Hospital, Belgium. Electronic address: rudy.vandenbroecke@ugent.be.'}, {'ForeName': 'De Visschere', 'Initials': 'V', 'LastName': 'Pieter', 'Affiliation': 'Dept. of Diagnostic Sciences, Ghent University, Belgium; Dept. of Radiology and Nuclear Medicine, Ghent University Hospital, Belgium. Electronic address: pieter.devisschere@ugent.be.'}, {'ForeName': 'Braems', 'Initials': 'B', 'LastName': 'Geert', 'Affiliation': 'Dept. of Human Structure and Repair, Ghent University, Belgium; Dept. of Gynaecology, Ghent University Hospital, Belgium. Electronic address: geert.braems@ugent.be.'}, {'ForeName': 'Vandecasteele', 'Initials': 'V', 'LastName': 'Katrien', 'Affiliation': 'Dept. of Human Structure and Repair, Ghent University, Belgium; Dept. of Radiation Oncology, Ghent University Hospital, Belgium. Electronic address: katrien.vandecasteele@ugent.be.'}, {'ForeName': 'Denys', 'Initials': 'D', 'LastName': 'Hannelore', 'Affiliation': 'Dept. of Medical Oncology, Ghent University Hospital, Belgium; Dept. of Internal Medicine and Pediatrics, Ghent University, Belgium. Electronic address: hannelore.denys@ugent.be.'}, {'ForeName': 'Veldeman', 'Initials': 'V', 'LastName': 'Liv', 'Affiliation': 'Dept. of Human Structure and Repair, Ghent University, Belgium; Dept. of Radiation Oncology, Ghent University Hospital, Belgium. Electronic address: liv.veldeman@ugent.be.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2022.01.010']
1778,35091204,"Cough desensitization treatment: A randomized, sham-controlled pilot trial for patients with refractory chronic cough.","BACKGROUND


The purpose of this study was to determine feasibility of treating refractory chronic cough (RCC) with progressive doses of capsaicin paired with cough suppression.
METHODS


In this sham-controlled, parallel RCT, 14 adults with RCC were randomly assigned to either behavioral cough suppression therapy (BCST) plus 6 treatment sessions involving exposure to nebulized capsaicin in progressively larger concentrations while actively suppressing cough (n = 8), or BCST plus 6 sessions of exposure to a single subthreshold dose of capsaicin (sham; n = 6). The Leicester Cough Questionnaire (LCQ) was the primary outcome measure. Urge-to-cough (UTC) testing, measuring both UTC and cough frequency, served as secondary outcome measures. Data was analyzed with mixed effects linear regression and follow-up contrasts.
RESULTS


Results on all measures favored the treatment group; however, there was only strong evidence of a difference in treatment effect on cough frequency during UTC testing. Mean change in LCQ at 3-weeks post treatment was 2.95 and 1.75 (p = .23), in the treatment and sham groups, respectively. Cough frequency during UTC testing reduced by 97% and 56% (p < .0001) at three weeks post, respectively. Within-group comparisons revealed strong evidence of change in the treatment group (p < .001) and moderate evidence of a change in the sham group (p = .08) in LCQ.
CONCLUSIONS


Conclusions from this study are limited due to the very small sample size; however, the study provides feasibility and proof-of-concept evidence to support further investigation of treating RCC with repeated exposure to nebulized capsaicin paired with BCST.",2022,"Cough frequency during UTC testing reduced by 97% and 56% (p < .0001) at three weeks post, respectively.","['14 adults with RCC', 'patients with refractory chronic cough']","['BCST plus 6 sessions of exposure to a single subthreshold dose of capsaicin', 'behavioral cough suppression therapy (BCST) plus 6 treatment sessions involving exposure to nebulized capsaicin', 'capsaicin']","['Mean change in LCQ', 'Cough frequency', 'cough frequency', 'Leicester Cough Questionnaire (LCQ', 'Urge-to-cough (UTC) testing, measuring both UTC and cough frequency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4552486', 'cui_str': 'Refractory chronic cough'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0522046', 'cui_str': 'Cough suppression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",14.0,0.326627,"Cough frequency during UTC testing reduced by 97% and 56% (p < .0001) at three weeks post, respectively.","[{'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Slovarp', 'Affiliation': 'School of Speech, Language, Hearing, & Occupational Sciences, University of Montana, 32 Campus Dr., Missoula, MT, USA. Electronic address: laurie.slovarp@umontana.edu.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Reynolds', 'Affiliation': 'School of Speech, Language, Hearing, & Occupational Sciences, University of Montana, 32 Campus Dr., Missoula, MT, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Bozarth-Dailey', 'Affiliation': 'School of Speech, Language, Hearing, & Occupational Sciences, University of Montana, 32 Campus Dr., Missoula, MT, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Popp', 'Affiliation': 'School of Speech, Language, Hearing, & Occupational Sciences, University of Montana, 32 Campus Dr., Missoula, MT, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Campbell', 'Affiliation': 'School of Speech, Language, Hearing, & Occupational Sciences, University of Montana, 32 Campus Dr., Missoula, MT, USA.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Morkrid', 'Affiliation': 'School of Speech, Language, Hearing, & Occupational Sciences, University of Montana, 32 Campus Dr., Missoula, MT, USA.'}]",Respiratory medicine,['10.1016/j.rmed.2022.106739']
1779,35104171,The feasibility of a self-management programme (My Life After Stroke; MLAS) for stroke survivors.,"PURPOSE


An evidence-based, theory-driven self-management programme ""My Life After Stroke"" (MLAS) was developed to address the longer-term unmet needs of stroke survivors.This study's aim was to test the acceptability and feasibility of MLAS as well as exploring what outcomes measures to include as part of further testing.
METHODS


Stroke registers in four GP practices across Leicester and Cambridge were screened, invite letters sent to eligible stroke survivors and written, informed consent gained. Questionnaires including Southampton Stroke Self-Management Questionnaire (SSSMQ) were completed before and after MLAS.Participants (and carers) attended MLAS (consisting of two individual appointments and four group sessions) over nine weeks, delivered by two trained facilitators. Feedback was gained from participants (after the final group session and final individual appointment) and facilitators.
RESULTS


Seventeen of 36 interested stroke survivors participated alongside seven associated carers. 15/17 completed the programme and attendance ranged from 13-17 per session. A positive change of 3.5 of the SSSMQ was observed. Positive feedback was gained from facilitators and 14/15 participants recommended MLAS (one did not respond).
CONCLUSIONS


MLAS was a feasible self-management programme for stroke survivors and warrants further testing as part of the Improving Primary Care After Stroke (IPCAS) cluster randomised controlled trial.IMPLICATIONS FOR REHABILITATIONMy Life After Stroke is a self-management programme developed for stroke survivors living in the community.MLAS is feasible and acceptable to stroke survivors.MLAS could be considered to help address the unmet educational and psychological needs of stroke survivors.",2022,IMPLICATIONS FOR REHABILITATIONMy Life,"['stroke survivors', 'stroke survivors living in the community', 'Seventeen of 36 interested stroke survivors', 'Stroke registers in four GP practices across Leicester and Cambridge were screened, invite letters sent to eligible stroke survivors and written, informed consent gained']","['self-management programme (My Life After Stroke; MLAS', 'MLAS']","['Positive feedback', 'Questionnaires including Southampton Stroke Self-Management Questionnaire (SSSMQ']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]",,0.0584472,IMPLICATIONS FOR REHABILITATIONMy Life,"[{'ForeName': 'V L', 'Initials': 'VL', 'LastName': 'Johnson', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Apps', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kreit', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mullis', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mant', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Disability and rehabilitation,['10.1080/09638288.2022.2029960']
1780,35094447,Efficacy and safety of topical timolol 0.5% plus saline 0.9% versus each one alone in acne scar trichloroacetic acid-CROSS therapy: A blinded randomized controlled trial.,"Trichloroacetic acid-CROSS (TCA-CROSS) or chemical reconstruction of scars is an approved method in the treatment of ICE-PICK scars. Timolol is a blocker of beta-adrenergic receptors that speeds up the healing of skin wounds. In this study, for the first time, the TCA-CROSS technique was combined with the use of saline injection and topical timolol to increase the effectiveness of treatment, and reduce the number of treatment sessions and complications, and thus improve the aesthetic result. In this parallel-group split-face randomized controlled assessor and analyst-blinded study, 45 patients with atrophic acne scars were randomly divided into 3 equal groups. TCA-CROSS treatment was performed on all facial scars of patients. In group 1, before TCA-CROSS, saline was injected under the scars on one side of the face, in group 2, after TCA-CROSS, 0.5% timolol eye drops were applied on the scars on one side, and in group 3, saline was injected before TCA-CROSS. After that, timolol eye drops were applied on the scars of the same side. In all groups, the choice of control side was random. The number of scars and patient and physician satisfaction were the main variables evaluating the effectiveness of the treatment. TCA-CROSS improved scars in both control and treatment sides of all 3 groups. Although the number of scars decreased on the treatment side of groups 2 and 3, the decrease was not statistically significant. In the saline + TCA group, the number of scars on the treatment side was slightly more than on the control side. In the group of patients who used timolol, the severity and duration of scar hyperpigmentation were significantly lower (group 2 p = 0.016, group 3 p = 0.002). No permanent complication was observed in the patients. Patients' satisfaction in groups 2 and 3 was higher in the treatment side than the control side. The combination of saline injection followed by TCA-CROSS is not recommended. Application of 0.5% timolol after TCA-CROSS caused a slight decrease in scar severity and a significant reduction of post-inflammatory hyperpigmentation (PIH) duration. So, the topical timolol makes a better result of TCA-CROSS for acne scar treatment.",2022,"Although the number of scars decreased on the treatment side of groups 2 and 3, the decrease was not statistically significant.",['45 patients with atrophic acne scars'],"['topical timolol 0.5% plus saline', 'saline injection followed by TCA-CROSS', 'Trichloroacetic acid-CROSS (TCA-CROSS', 'Timolol', 'TCA-CROSS, saline', 'saline + TCA', 'topical timolol', 'TCA-CROSS, 0.5% timolol', 'TCA-CROSS treatment', 'timolol', 'saline injection and topical timolol']","['Efficacy and safety', 'severity and duration of scar hyperpigmentation', 'permanent complication', 'post-inflammatory hyperpigmentation (PIH) duration', 'scar severity', 'number of scars and patient and physician satisfaction', 'number of scars', 'TCA-CROSS improved scars']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040900', 'cui_str': 'Trichloroacetic acid'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0041405', 'cui_str': 'Turks and Caicos Islands'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0040900', 'cui_str': 'Trichloroacetic acid'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}]",45.0,0.0154379,"Although the number of scars decreased on the treatment side of groups 2 and 3, the decrease was not statistically significant.","[{'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Ghassemi', 'Affiliation': 'Department of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mohamad Hasan', 'Initials': 'MH', 'LastName': 'Shahverdi', 'Affiliation': 'Department of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Behrangi', 'Affiliation': 'Department of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Fatemeh Sadat', 'Initials': 'FS', 'LastName': 'Hosseini-Baharanchi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Goodarzi', 'Affiliation': 'Department of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]",Dermatologic therapy,['10.1111/dth.15341']
1781,35094436,Diabetes workshops for providers improve glucose control in coronary artery bypass grafting patients.,"OBJECTIVES


Postoperative hyperglycemia occurs in up to 80% of cardiac surgery patients and is associated with poor outcomes. We sought to determine if case-based diabetes workshops for providers would improve postoperative glycemic control and outcomes in patients undergoing coronary artery bypass grafting  (CABG).
METHODS


Healthcare providers taking care of patients in the cardiothoracic step-down unit underwent 30-min weekly case-based diabetes workshops over 6 months. Workshops focused on initiation of insulin treatment, titration of insulin dosing, and transitioning from insulin drips to subcutaneous insulin. Isolated-CABG patients were recorded during 29-month periods before (Jan 2013-June 2015) and after training (Jan 2016-June 2018). Glycemic control and outcomes were compared between groups balanced for preoperative risk factors using inverse probability treatment weights.
RESULTS


A total of 938 and 1032 patients were included in pre- and posttraining groups, respectively. Compared to the pretraining period, the posttraining period had a lower median of mean patient day glucose levels (151 vs. 144 mg/dl, p < .001) and percentage of patient days with a glucose level >250 mg/dl (20% vs. 14%, p < .001). The percentage of patient days with mean glucose values in the target range (80-180 mg/dl) increased from 71% to 77% (p < .001). The incidence of hypoglycemic events did not significantly change after training (p = .15). The incidence of sepsis was significantly lower in the posttraining period (1.7% vs. 0.2%, p < .001).
CONCLUSIONS


Weekly diabetes workshops for healthcare providers were associated with improved glycemic control and reduced postoperative sepsis among isolated CABG patients.",2022,The incidence of hypoglycemic events did not significantly change after training (p = .15).,"['A total of 938 and 1032 patients were included in pre- and posttraining groups, respectively', 'coronary artery bypass grafting patients', 'patients undergoing coronary artery bypass grafting\xa0 (CABG', 'Healthcare providers taking care of patients in the cardiothoracic step-down unit underwent 30-min weekly case-based diabetes workshops over 6 months']",[],"['median of mean patient day glucose levels', 'percentage of patient days with a glucose level', 'glycemic control and reduced postoperative sepsis', 'incidence of sepsis', 'incidence of hypoglycemic events', 'percentage of patient days with mean glucose values']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C3698200', 'cui_str': 'Postoperative sepsis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0368755,The incidence of hypoglycemic events did not significantly change after training (p = .15).,"[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Bogun', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Columbia University Irving Medical Center, New York City, New York, USA.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Beier', 'Affiliation': 'Division of Cardiac, Thoracic, and Vascular Surgery, Department of Surgery, Columbia University Irving Medical Center, New York City, New York, USA.'}, {'ForeName': 'Sameer K', 'Initials': 'SK', 'LastName': 'Singh', 'Affiliation': 'Division of Cardiac, Thoracic, and Vascular Surgery, Department of Surgery, Columbia University Irving Medical Center, New York City, New York, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'McLaughlin', 'Affiliation': 'Division of Cardiac, Thoracic, and Vascular Surgery, Department of Surgery, Columbia University Irving Medical Center, New York City, New York, USA.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': 'Department of Surgery, Center for Innovation and Outcomes Research, Columbia University Irving Medical Center, New York City, New York, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kurlansky', 'Affiliation': 'Division of Cardiac, Thoracic, and Vascular Surgery, Department of Surgery, Columbia University Irving Medical Center, New York City, New York, USA.'}, {'ForeName': 'Syed T', 'Initials': 'ST', 'LastName': 'Raza', 'Affiliation': 'Division of Cardiac, Thoracic, and Vascular Surgery, Department of Surgery, Columbia University Irving Medical Center, New York City, New York, USA.'}]",Journal of cardiac surgery,['10.1111/jocs.16282']
1782,34879986,Feasibility of Post-hospitalization Telemedicine Video Visits for Children With Medical Complexity.,"OBJECTIVES


To evaluate feasibility and acceptability of post-hospitalization telemedicine video visits (TMVV) during hospital-to-home transitions for children with medical complexity (CMC); and explore associations with hospital utilization, caregiver self-efficacy (CSE), and family self-management (FSM).
METHOD


This non-randomized pilot study assigned CMC (n=28) to weekly TMVV for four weeks post-hospitalization; control CMC (n=20) received usual care without telemedicine. Feasibility was measured by time to connection and proportion of TMVV completed; acceptability was measured by parent-reported surveys. Pre/post-discharge changes in CSE, FSM, and hospital utilization were assessed.
RESULTS


64 TMVV were completed; 82 % of patients completed 1 TMVV; 54 % completed four TMVV. Median time to TMVV connection was 1 minute (IQR=2.5). Parents reported high acceptability of TMVV (mean 6.42; 1 -7 scale). CSE and FSM pre/post-discharge were similar for both groups; utilization declined in both groups post-discharge.
DISCUSSION


Post-hospitalization TMVV for CMC were feasible and acceptable during hospital-to-home transitions.",2022,"CSE and FSM pre/post-discharge were similar for both groups; utilization declined in both groups post-discharge.
","['children with medical complexity (CMC', 'Children With Medical Complexity']","['CMC', 'usual care without telemedicine', 'post-hospitalization telemedicine video visits (TMVV', 'TMVV', 'Pos-thospitalization Telemedicine Video Visits']","['time to connection and proportion of TMVV completed; acceptability', 'Median time to TMVV connection', 'CSE, FSM, and hospital utilization', 'acceptability of TMVV']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1262869', 'cui_str': 'Body position'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",64.0,0.0143581,"CSE and FSM pre/post-discharge were similar for both groups; utilization declined in both groups post-discharge.
","[{'ForeName': 'David Y', 'Initials': 'DY', 'LastName': 'Ming', 'Affiliation': ''}, {'ForeName': 'Tingxuan', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Melissa H', 'Initials': 'MH', 'LastName': 'Ross', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Frush', 'Affiliation': ''}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Goldstein', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Jarrett', 'Affiliation': ''}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Krohl', 'Affiliation': ''}, {'ForeName': 'Sharron L', 'Initials': 'SL', 'LastName': 'Docherty', 'Affiliation': ''}, {'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Turley', 'Affiliation': ''}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2021.10.001']
1783,34880074,Mycophenolate Mofetil after Rituximab for Childhood-Onset Complicated Frequently-Relapsing or Steroid-Dependent Nephrotic Syndrome.,"BACKGROUND


Rituximab is the standard therapy for childhood-onset complicated frequently relapsing or steroid-dependent nephrotic syndrome (FRNS/SDNS). However, most patients redevelop FRNS/SDNS after peripheral B cell recovery.
METHODS


We conducted a multicenter, randomized, double-blind, placebo-controlled trial to examine whether mycophenolate mofetil (MMF) administration after rituximab can prevent treatment failure (FRNS, SDNS, steroid resistance, or use of immunosuppressive agents or rituximab). In total, 39 patients (per group) were treated with rituximab, followed by either MMF or placebo until day 505 (treatment period). The primary outcome was time to treatment failure (TTF) throughout the treatment and follow-up periods (until day 505 for the last enrolled patient).
RESULTS


TTFs were clinically but not statistically significantly longer among patients given MMF after rituximab than among patients receiving rituximab monotherapy (median, 784.0 versus 472.5 days, hazard ratio [HR], 0.59; 95% confidence interval [95% CI], 0.34 to 1.05, log-rank test:  P =0.07). Because most patients in the MMF group presented with treatment failure after MMF discontinuation, we performed a  post-hoc  analysis limited to the treatment period and found that MMF after rituximab prolonged the TTF and decreased the risk of treatment failure by 80% (HR, 0.20; 95% CI, 0.08 to 0.50). Moreover, MMF after rituximab reduced the relapse rate and daily steroid dose during the treatment period by 74% and 57%, respectively. The frequency and severity of adverse events were similar in both groups.
CONCLUSIONS


Administration of MMF after rituximab may sufficiently prevent the development of treatment failure and is well tolerated, although the relapse-preventing effect disappears after MMF discontinuation.",2022,"RESULTS


TTFs were clinically but not statistically significantly longer among patients given MMF after rituximab than among patients receiving rituximab monotherapy (median, 784.0 versus 472.5 days, hazard ratio [HR], 0.59; 95% confidence interval [95% CI], 0.34 to 1.05, log-rank test:  P =0.07).",['39 patients (per group) were treated with'],"['placebo', 'Rituximab', 'Mycophenolate Mofetil after Rituximab', 'MMF or placebo', 'MMF', 'mycophenolate mofetil (MMF) administration after rituximab', 'rituximab']","['relapse rate and daily steroid dose', 'frequency and severity of adverse events', 'risk of treatment failure', 'time to treatment failure (TTF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",39.0,0.184635,"RESULTS


TTFs were clinically but not statistically significantly longer among patients given MMF after rituximab than among patients receiving rituximab monotherapy (median, 784.0 versus 472.5 days, hazard ratio [HR], 0.59; 95% confidence interval [95% CI], 0.34 to 1.05, log-rank test:  P =0.07).","[{'ForeName': 'Kazumoto', 'Initials': 'K', 'LastName': 'Iijima', 'Affiliation': 'Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan iijima@med.kobe-u.ac.jp kdiijima_kch@hp.pref.hyogo.jp.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Sako', 'Affiliation': 'Department of Clinical Research Promotion, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Oba', 'Affiliation': 'Department of Medical Statistics, Toho University, Tokyo, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Pediatrics and Child Health, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Riku', 'Initials': 'R', 'LastName': 'Hamada', 'Affiliation': ""Department of Nephrology, Tokyo Metropolitan Children's Medical Center, Fuchu, Japan.""}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Department of Pediatrics, Shiga University of Medical Science, Otsu, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Ohwada', 'Affiliation': 'Department of Pediatrics, Dokkyo Medical University School of Medicine, Mibu, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Ninchoji', 'Affiliation': 'Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Yamamura', 'Affiliation': 'Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Machida', 'Affiliation': 'Department of Pediatrics, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Shima', 'Affiliation': 'Department of Pediatrics, Wakayama Medical University, Wakayama City, Japan.'}, {'ForeName': 'Ryojiro', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': ""Department of Nephrology, Hyogo Prefectural Kobe Children's Hospital, Kobe, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kaito', 'Affiliation': 'Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Araki', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Hokkaido Medical Center, Sapporo, Japan.'}, {'ForeName': 'Tamaki', 'Initials': 'T', 'LastName': 'Morohashi', 'Affiliation': 'Department of Pediatrics, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naonori', 'Initials': 'N', 'LastName': 'Kumagai', 'Affiliation': 'Department of Pediatrics, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Gotoh', 'Affiliation': 'Department of Pediatrics, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Ikezumi', 'Affiliation': 'Department of Pediatrics, Fujita Health University School of Medicine, Toyoake, Japan.'}, {'ForeName': 'Takuo', 'Initials': 'T', 'LastName': 'Kubota', 'Affiliation': 'Department of Pediatrics, Osaka University, Suita, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kamei', 'Affiliation': 'Division of Nephrology and Rheumatology, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Fujita', 'Affiliation': ""Department of Nephrology, Aichi Children's Health and Medical Center, Obu, Japan.""}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Ohtsuka', 'Affiliation': 'Department of Pediatrics, Saga University, Saga City, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': 'Department of Pediatrics, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Pediatrics, Niigata University Medical and Dental Hospital, Niigata City, Japan.'}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Tanaka', 'Affiliation': 'Department of Pediatrics and Developmental Biology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Shimizu', 'Affiliation': 'Department of Pediatrics, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Horinouchi', 'Affiliation': 'Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Akihide', 'Initials': 'A', 'LastName': 'Konishi', 'Affiliation': 'Clinical and Translational Research Center, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Clinical and Translational Research Center, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakanishi', 'Affiliation': 'Department of Child Health and Welfare (Pediatrics), Graduate School of Medicine, University of the Ryukyus, Nishihara, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ishikura', 'Affiliation': 'Department of Pediatrics, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Department of Pediatrics, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Hidefumi', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Department of Research and Development Supervision, Clinical Research Center, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Kandai', 'Initials': 'K', 'LastName': 'Nozu', 'Affiliation': 'Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2021050643']
1784,34893535,Effect of a 3-Year Lifestyle Intervention in Patients with Chronic Kidney Disease: A Randomized Clinical Trial.,"BACKGROUND


Supervised lifestyle interventions have the potential to significantly improve physical activity and fitness in patients with CKD.
METHODS


To assess the efficacy of a lifestyle intervention in patients with CKD to improve cardiorespiratory fitness and exercise capacity over 36 months, we conducted a randomized clinical trial, enrolling 160 patients with stage 3-4 CKD, with 81 randomized to usual care and 79 to a 3-year lifestyle intervention. The lifestyle intervention comprised care from a multidisciplinary team, including a nephrologist, nurse practitioner, exercise physiologist, dietitian, diabetes educator, psychologist, and social worker. The exercise training component consisted of an 8-week individualized and supervised gym-based exercise intervention followed by 34 months of a predominantly home-based program. Self-reported physical activity (metabolic equivalent of tasks [METs] minutes per week), cardiorespiratory fitness (peak O 2  consumption [VO 2peak ]), exercise capacity (maximum METs and 6-minute walk distance) and neuromuscular fitness (grip strength and get-up-and-go test time) were evaluated at 12, 24, and 36 months.
RESULTS


The intervention increased the percentage of patients meeting physical activity guideline targets of 500 MET min/wk from 29% at baseline to 63% at 3 years. At 12 months, both VO 2peak  and METs increased significantly in the lifestyle intervention group by 9.7% and 30%, respectively, without change in the usual care group. Thereafter, VO 2peak  declined to near baseline levels, whereas METs remained elevated in the lifestyle intervention group at 24 and 36 months. After 3 years, the intervention had increased the 6-minute walk distance and blunted declines in the get-up-and-go test time.
CONCLUSIONS


A 3-year lifestyle intervention doubled the percentage of CKD patients meeting physical activity guidelines, improved exercise capacity, and ameliorated losses in neuromuscular and cardiorespiratory fitness.",2022,"After 3 years, the intervention had increased the 6-minute walk distance and blunted declines in the get-up-and-go test time.
","['patients with CKD', '160 patients with stage 3-4 CKD, with 81 randomized to usual care and 79 to a 3-year lifestyle intervention', 'Patients with Chronic Kidney Disease']","['3-Year Lifestyle Intervention', 'lifestyle intervention', 'exercise training component consisted of an 8-week individualized and supervised gym-based exercise intervention followed by 34 months of a predominantly home-based program', 'lifestyle intervention comprised care from a multidisciplinary team, including a nephrologist, nurse practitioner, exercise physiologist, dietitian, diabetes educator, psychologist, and social worker']","['Self-reported physical activity (metabolic equivalent of tasks', 'percentage of patients meeting physical activity guideline targets', 'cardiorespiratory fitness (peak O 2  consumption [VO 2peak ]), exercise capacity (maximum METs and 6-minute walk distance) and neuromuscular fitness (grip strength and get-up-and-go test time', 'VO 2peak  and METs', 'physical activity and fitness', '6-minute walk distance and blunted declines in the get-up-and-go test time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0260039', 'cui_str': 'Nephrologist'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0260141', 'cui_str': 'Physiologist'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2983100', 'cui_str': 'Metabolic equivalent of task'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C1303170', 'cui_str': 'Get up and go test'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}]",160.0,0.0159176,"After 3 years, the intervention had increased the 6-minute walk distance and blunted declines in the get-up-and-go test time.
","[{'ForeName': 'Kassia S', 'Initials': 'KS', 'LastName': 'Beetham', 'Affiliation': 'School of Behavioural and Health Science, Australian Catholic University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Rathika', 'Initials': 'R', 'LastName': 'Krishnasamy', 'Affiliation': 'Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Stanton', 'Affiliation': 'Sunshine Coast University Hospital, Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Julian W', 'Initials': 'JW', 'LastName': 'Sacre', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Douglas', 'Affiliation': 'School of Nursing and Midwifery, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Isbel', 'Affiliation': 'Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Erin J', 'Initials': 'EJ', 'LastName': 'Howden', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia erin.howden@baker.edu.au.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2021050668']
1785,35098880,Matching design for augmenting the control arm of a randomized controlled trial using real-world data.,"Randomized clinical trials (RCTs) have often been considered as the gold standard in drug development, but they may not be fully powered due to limited patient population and can even lead to ethical concerns in rare disease studies. In situations like this, real-world data (RWD)/historical data can be utilized to augment or possibly serve as the control arm for the current trial. If a subset of subjects from the RWD/historical trial could be matched to the concurrent control arm subjects and they are deemed comparable following certain criteria, then pooling the matched subjects from the historical control arm and the concurrent control arm can boost the power. In this paper, we propose two matching methods of borrowing historical control data that not only balance key observed baseline covariates but also ensure the comparability of responses between the historical and concurrent controls. Close similarity in response variables among controls reduces Type I error inflation and provides further protection against unmeasured confounding bias, which is a major challenge in using RWD. Simulation studies are conducted to evaluate the empirical performance of the two matching methods in terms of Type I error rate and power, and an illustrative description of a planned study is presented.",2022,"Simulation studies are conducted to evaluate the empirical performance of the two matching methods in terms of Type I error rate and power, and an illustrative description of a planned study is presented.",[],[],[],[],[],[],,0.11525,"Simulation studies are conducted to evaluate the empirical performance of the two matching methods in terms of Type I error rate and power, and an illustrative description of a planned study is presented.","[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Global Analytics and Data Sciences, Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Division of Biostatistics, College of Public Health, the Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Foster', 'Affiliation': 'Global Analytics and Data Sciences, Biogen, Maidenhead Berkshire, UK.'}, {'ForeName': 'Yiwei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Biostatistics, Apellis Pharmaceuticals, Waltham, Massachusetts, USA.'}, {'ForeName': 'Z John', 'Initials': 'ZJ', 'LastName': 'Zhong', 'Affiliation': 'Biometrics, REGENXBIO, Rockville, Maryland, USA.'}, {'ForeName': 'Ming-Hui', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Department of Statistics, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Sun', 'Affiliation': 'Global Analytics and Data Sciences, Biogen, Cambridge, Massachusetts, USA.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2021.2011900']
1786,35092886,Do the effects of parent-based alcohol interventions depend on college residence? A short communication.,"Parent-based interventions (PBIs) and living at home with one's parents both have been shown to mitigate alcohol risk associated with the first year of college. The current study extends these findings by examining the independent and interactive effects of these two constructs on first-year drinking. The sample included 82 parent-student dyads. Parents were randomized to receive an online PBI that either did (intervention; n = 44) or did not (n = 38) include alcohol-related content in December 2020. Students completed online surveys assessing college residence and drinking (typical weekly and peak) in August 2020 (T1) and February 2021 (T2). Hierarchical zero-inflated Poisson models assessed the main and interaction effects of having a parent in the intervention group (vs control) and living with parents (vs without) on drinking outcomes, controlling for T1 alcohol use. Results revealed that living with parents predicted decreases in typical weekly drinking and having a parent in the intervention predicted decreases in the number of drinks consumed on one's peak drinking occasion at T2. Treatment*residence was also significantly associated with typical weekly drinking in the inflated model. These results suggest that moving out was associated with a greater likelihood of not drinking during a typical week if students had a parent in the intervention and a lower likelihood of not drinking during a typical week if they had a parent in the control application. Together, findings support continued exploration of this online PBI as it appears to reduce peak drinking during the first year of college and reduces the odds of students drinking during a typical week when they move out of their parents' home.",2022,Results revealed that living with parents predicted decreases in typical weekly drinking and having a parent in the intervention predicted decreases in the number of drinks consumed on one's peak drinking occasion at T2.,"['Students completed online surveys assessing college residence and drinking (typical weekly and peak) in August 2020 (T1) and February 2021 (T2', 'The sample included 82 parent-student dyads']","['online PBI that either did (intervention; n\xa0=\xa044) or did not (n\xa0=\xa038) include alcohol-related content in December 2020', 'parent-based alcohol interventions']",['peak drinking'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",,0.00883032,Results revealed that living with parents predicted decreases in typical weekly drinking and having a parent in the intervention predicted decreases in the number of drinks consumed on one's peak drinking occasion at T2.,"[{'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'LaBrie', 'Affiliation': 'Department of Psychology, Loyola Marymount University, USA. Electronic address: jlabrie@lmu.edu.'}, {'ForeName': 'Bradley M', 'Initials': 'BM', 'LastName': 'Trager', 'Affiliation': 'Department of Psychology, Loyola Marymount University, USA.'}, {'ForeName': 'Reed M', 'Initials': 'RM', 'LastName': 'Morgan', 'Affiliation': 'Department of Psychology, Loyola Marymount University, USA.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Boyle', 'Affiliation': 'Department of Psychology, Loyola Marymount University, USA.'}, {'ForeName': 'J Eason', 'Initials': 'JE', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychology, Loyola Marymount University, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Turrisi', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, USA; Edna Bennett Pierce Prevention Research Center, College of Health and Human Development, The Pennsylvania State University, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2022.107257']
1787,35097222,Azithromycin and cefixime combination versus azithromycin alone for the out-patient treatment of clinically suspected or confirmed uncomplicated typhoid fever in South Asia: a randomised controlled trial protocol.,"Background:  Typhoid and paratyphoid fever (enteric fever) is a common cause of non-specific febrile infection in adults and children presenting to health care facilities in low resource settings such as the South Asia.  A 7-day course of a single oral antimicrobial such as ciprofloxacin, cefixime, or azithromycin is commonly used for its treatment. Increasing antimicrobial resistance threatens the effectiveness of these treatment choices. We hypothesize that combined treatment with azithromycin (active mainly intracellularly) and cefixime (active mainly extracellularly) will be a better option for the treatment of clinically suspected and culture-confirmed typhoid fever in South Asia.  Methods:  This is a phase IV, international multi-center, multi-country, comparative participant-and observer-blind, 1:1 randomised clinical trial. Patients with suspected uncomplicated typhoid fever will be randomized to one of the two interventions: Arm A: azithromycin 20mg/kg/day oral dose once daily (maximum 1gm/day) and cefixime 20mg/kg/day oral dose in two divided doses (maximum 400mg bd) for 7 days, Arm B: azithromycin 20mg/kg/day oral dose once daily (max 1gm/day) for 7 days AND cefixime-matched placebo for 7 days. We will recruit 1500 patients across sites in Bangladesh, India, Nepal, and Pakistan. We will assess whether treatment outcomes are better with the combination after one week of treatment and at one- and three-months follow-up.  Discussion:  Combined treatment may limit the emergence of resistance if one of the components is active against resistant sub-populations not covered by the other antimicrobial activity. If the combined treatment is better than the single antimicrobial treatment, this will be an important result for patients across South Asia and other typhoid endemic areas.  Clinicaltrials.gov registration:  NCT04349826 (16/04/2020).",2021,Combined treatment may limit the emergence of resistance if one of the components is active against resistant sub-populations not covered by the other antimicrobial activity.,"['adults and children presenting to health care facilities in low resource settings such as the South Asia', 'Patients with suspected uncomplicated typhoid fever', '1500 patients across sites in Bangladesh, India, Nepal, and Pakistan', 'out-patient treatment of clinically suspected or confirmed uncomplicated typhoid fever in South Asia', 'patients across South Asia and other typhoid endemic areas']","['azithromycin (active mainly intracellularly) and cefixime', 'cefixime-matched placebo', 'Azithromycin and cefixime combination versus azithromycin', 'cefixime', 'azithromycin', 'ciprofloxacin, cefixime, or azithromycin']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0041466', 'cui_str': 'Typhoid fever'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0060400', 'cui_str': 'Cefixime'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}]",[],1500.0,0.154527,Combined treatment may limit the emergence of resistance if one of the components is active against resistant sub-populations not covered by the other antimicrobial activity.,"[{'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Giri', 'Affiliation': 'Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Scineces, Lalitpur, Bagmati, 44700, Nepal.'}, {'ForeName': 'Abhilasha', 'Initials': 'A', 'LastName': 'Karkey', 'Affiliation': 'Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Scineces, Lalitpur, Bagmati, 44700, Nepal.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Dongol', 'Affiliation': 'Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Scineces, Lalitpur, Bagmati, 44700, Nepal.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Arjyal', 'Affiliation': 'Patan Academy of Health Sciences, Lalitpur, Bagmati, 44700, Nepal.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Maharjan', 'Affiliation': 'Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Scineces, Lalitpur, Bagmati, 44700, Nepal.'}, {'ForeName': 'Balaji', 'Initials': 'B', 'LastName': 'Veeraraghavan', 'Affiliation': 'Christian Medical College, Vellore, Tamil Nadu, 632004, India.'}, {'ForeName': 'Buddhi', 'Initials': 'B', 'LastName': 'Paudyal', 'Affiliation': 'Patan Academy of Health Sciences, Lalitpur, Bagmati, 44700, Nepal.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Dolecek', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Damodar', 'Initials': 'D', 'LastName': 'Gajurel', 'Affiliation': 'CIvil Service Hospital, Kathmandu, 44600, Nepal.'}, {'ForeName': 'Dung Nguyen Thi', 'Initials': 'DNT', 'LastName': 'Phuong', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Duy Pham', 'Initials': 'DP', 'LastName': 'Thanh', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Qamar', 'Affiliation': 'Aga Khan University Hospital, Karachi, 74800, Pakistan.'}, {'ForeName': 'Gagandeep', 'Initials': 'G', 'LastName': 'Kang', 'Affiliation': 'Christian Medical College, Vellore, Tamil Nadu, 632004, India.'}, {'ForeName': 'Ho Van', 'Initials': 'HV', 'LastName': 'Hien', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'John', 'Affiliation': 'Christian Medical College, Vellore, Tamil Nadu, 632004, India.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Lawson', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Wolbers', 'Affiliation': 'Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Scineces, Lalitpur, Bagmati, 44700, Nepal.'}, {'ForeName': 'Md Shabab', 'Initials': 'MS', 'LastName': 'Hossain', 'Affiliation': 'International Centre for Diarrhoeal Disease Research (icddr, b), Dhaka, Bangladesh.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sharifuzzaman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research (icddr, b), Dhaka, Bangladesh.'}, {'ForeName': 'Nantasit', 'Initials': 'N', 'LastName': 'Luangasanatip', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, 10400, Thailand.'}, {'ForeName': 'Nhukesh', 'Initials': 'N', 'LastName': 'Maharjan', 'Affiliation': 'Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Scineces, Lalitpur, Bagmati, 44700, Nepal.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Olliaro', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Rupali', 'Affiliation': 'Christian Medical College, Vellore, Tamil Nadu, 632004, India.'}, {'ForeName': 'Ronas', 'Initials': 'R', 'LastName': 'Shakya', 'Affiliation': 'Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Scineces, Lalitpur, Bagmati, 44700, Nepal.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Shakoor', 'Affiliation': 'Aga Khan University Hospital, Karachi, 74800, Pakistan.'}, {'ForeName': 'Samita', 'Initials': 'S', 'LastName': 'Rijal', 'Affiliation': 'Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Scineces, Lalitpur, Bagmati, 44700, Nepal.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Qureshi', 'Affiliation': 'Aga Khan University Hospital, Karachi, 74800, Pakistan.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'Department of Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Subi', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Scineces, Lalitpur, Bagmati, 44700, Nepal.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'International Centre for Diarrhoeal Disease Research (icddr, b), Dhaka, Bangladesh.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Darton', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, South Yorkshire, UK.'}, {'ForeName': 'Tran Nguyen', 'Initials': 'TN', 'LastName': 'Bao', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Yoel', 'Initials': 'Y', 'LastName': 'Lubell', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, 10400, Thailand.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Kestelyn', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Thwaites', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Parry', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Buddha', 'Initials': 'B', 'LastName': 'Basnyat', 'Affiliation': 'Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Scineces, Lalitpur, Bagmati, 44700, Nepal.'}]",Wellcome open research,['10.12688/wellcomeopenres.16801.2']
1788,34973513,Pembrolizumab versus chemotherapy for patients with esophageal squamous cell carcinoma enrolled in the randomized KEYNOTE-181 trial in Asia.,"BACKGROUND


In the randomized phase III KEYNOTE-181 study, pembrolizumab prolonged overall survival (OS) compared with chemotherapy as second-line therapy in patients with advanced esophageal cancer and programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥10. We report a post hoc subgroup analysis of patients with esophageal squamous cell carcinoma (ESCC) enrolled in KEYNOTE-181 in Asia, including patients from the KEYNOTE-181 China extension study.
PATIENTS AND METHODS


Three hundred and forty Asian patients with advanced/metastatic ESCC were enrolled in KEYNOTE-181, including the China cohort. Patients were randomly assigned 1 : 1 to receive pembrolizumab 200 mg every 3 weeks for ≤2 years or investigator's choice of paclitaxel, docetaxel, or irinotecan. OS, progression-free survival, response, and safety were analyzed without formal comparisons. OS was evaluated based on PD-L1 CPS expression level.
RESULTS


In Asian patients with ESCC, median OS was 10.0 months with pembrolizumab and 6.5 months with chemotherapy [hazard ratio (HR), 0.63; 95% CI 0.50-0.80; nominal P < 0.0001]. Median progression-free survival was 2.3 months with pembrolizumab and 3.1 months with chemotherapy (HR, 0.79; 95% CI 0.63-0.99; nominal P = 0.020). Objective response rate was 17.1% with pembrolizumab and 7.1% with chemotherapy; median duration of response was 10.5 months and 7.7 months, respectively. In patients with PD-L1 CPS <1 tumors (pembrolizumab versus chemotherapy), the HR was 0.99 (95% CI 0.56-1.72); the HR (95% CI) for death was better for patients with PD-L1 CPS cut-offs >1 [CPS ≥1, 0.57 (0.44-0.75); CPS ≥5, 0.56 (0.41-0.76); CPS ≥10, 0.53 (0.37-0.75)]. Treatment-related adverse events were reported in 71.8% of patients in the pembrolizumab group and 89.8% in the chemotherapy group; grade 3-5 events were reported in 20.0% and 44.6%, respectively.
CONCLUSIONS


Pembrolizumab monotherapy demonstrated promising efficacy in Asian patients with ESCC, with fewer treatment-related adverse events than chemotherapy. PD-L1 CPS ≥1 is an appropriate cut-off and a predictive marker of pembrolizumab efficacy in Asian patients with ESCC.",2022,"Treatment-related adverse events were reported in 71.8% of patients in the pembrolizumab group and 89.8% in the chemotherapy group; grade 3-5 events were reported in 20.0% and 44.6%, respectively.
","['patients with advanced esophageal cancer and', 'patients with esophageal squamous cell carcinoma (ESCC) enrolled in KEYNOTE-181 in Asia, including patients from the KEYNOTE-181 China extension study', 'Asian patients with ESCC', 'patients with esophageal squamous cell carcinoma', 'Three hundred and forty Asian patients with advanced/metastatic ESCC were enrolled in KEYNOTE-181, including the China cohort']","['chemotherapy', 'pembrolizumab', 'Pembrolizumab monotherapy', 'Pembrolizumab versus chemotherapy', ""pembrolizumab 200 mg every 3 weeks for ≤2 years or investigator's choice of paclitaxel, docetaxel, or irinotecan"", 'PD-L1 CPS']","['overall survival (OS', 'OS, progression-free survival, response, and safety', 'death', 'median OS', 'Objective response rate', 'adverse events', 'Median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C1142025', 'cui_str': 'Oesophageal squamous cell carcinoma stage IV'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",340.0,0.393342,"Treatment-related adverse events were reported in 71.8% of patients in the pembrolizumab group and 89.8% in the chemotherapy group; grade 3-5 events were reported in 20.0% and 44.6%, respectively.
","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China. Electronic address: yanshuo.cao@icloud.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'PLA Cancer Centre of Nanjing Bayi Hospital, Nanjing, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'The Affiliated Tumor Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, Jilin, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Cancer Hospital of University of Chinese Academy of Sciences, Institute of Cancer and Basic Medicine of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, and The Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': 'Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Tongji Hospital, Wuhan, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Hubei Cancer Hospital, Wuhan, China.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'S-B', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kojima', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Ruijin Hospital, Shanghai, China.'}, {'ForeName': 'S-H', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Doi', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gu', 'Affiliation': 'The First Affiliated Hospital of Anhui Medical University, Anhui Medical University, Hefei, China.'}, {'ForeName': 'H-M', 'Initials': 'HM', 'LastName': 'Pan', 'Affiliation': 'Sir Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'J-W', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'Fujian Province Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'MSD China, Shanghai, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'MSD China, Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing, China.'}]",ESMO open,['10.1016/j.esmoop.2021.100341']
1789,35093794,Public support for policies to improve population and planetary health: A population-based online experiment assessing impact of communicating evidence of multiple versus single benefits.,"BACKGROUND


Effective interventions for reducing the consumption of products that harm population and planetary health often lack public support, impeding implementation. Communicating evidence of policies' effectiveness can increase public support but there is uncertainty about the most effective ways of communicating this evidence. Some policies have multiple benefits such as both improving health and the environment. This study assesses whether communicating evidence of multiple versus single benefits of a policy increases its support.
METHOD


Participants (n = 4616) nationally representative of the British population were randomised to one of 24 groups in an online experiment with a 4 × 3 × 2 between-subjects factorial design. The messages that participants viewed differed according to the evidence they communicated (no message, effectiveness for changing behaviour, effectiveness for changing behaviour + one policy benefit, effectiveness for changing behaviour + three policy benefits), type of policy (taxation, availability) and the target behaviour (consumption of energy-dense food, alcohol, or meat). The primary outcome was policy support.
RESULTS


In a full factorial ANOVA, there was a significant main effect of communicating evidence of effectiveness on policy support, which was similar across policies and behaviours. Communicating three benefits increased support relative to communicating one benefit (d = 0.15; p = 0.01). Communicating one benefit increased support compared to providing evidence for changing behaviour alone (d = 0.13; p = 0.004) or no message (d = 0.11 p = 0.022).
CONCLUSION


Communicating evidence of a policy's benefits increases support for policy action across different behaviours and policies. Presenting multiple benefits of policies enhances public support.",2022,Communicating three benefits increased support relative to communicating one benefit (d = 0.15; p = 0.01).,"['4616) nationally representative of the British population were randomised to one of 24 groups in an online experiment with a 4\xa0×\xa03 × 2 between-subjects factorial design', 'Participants (n\xa0']",[],['policy support'],"[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]",[],"[{'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",,0.0672541,Communicating three benefits increased support relative to communicating one benefit (d = 0.15; p = 0.01).,"[{'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Mantzari', 'Affiliation': 'Behaviour and Health Research Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Reynolds', 'Affiliation': 'Behaviour and Health Research Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Hollands', 'Affiliation': 'Behaviour and Health Research Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Pilling', 'Affiliation': 'Behaviour and Health Research Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK. Electronic address: tm388@medschl.cam.ac.uk.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2022.114726']
1790,35101724,Effects of neurodynamic interventions on pain sensitivity and function in patients with multiple sclerosis: a randomized clinical trial.,"OBJECTIVE


To assess the effects of adding a neurodynamic intervention into a multimodal management approach in individuals with multiple sclerosis (MS) with upper extremity pain symptoms.
DESIGN


Randomized clinical trial.
SETTING


Tertiary hospital center.
PARTICIPANTS


Thirty-two individuals with MS were randomly assigned to multimodal usual care alone (n=16) or multimodal usual care plus neurodynamic intervention (n=16).
INTERVENTIONS


Both groups received 5 sessions of multimodal usual care of 30minutes duration, twice per week. Subjects allocated to the neurodynamic group also received bilateral neurodynamic slider interventions targeting the upper extremity nerve trunks.
OUTCOME MEASURES


Pressure pain thresholds (PPTs) at the radial, median and ulnar nerve trunks, second metacarpal and tibialis anterior, pain intensity in the upper extremity (NPRS, 0-10), light touch detection threshold (von Frey hairs) and manual dexterity (nine-hole peg test) were assessed before and after the intervention.
RESULTS


Subjects receiving the neurodynamic interventions experienced larger improvements in PPTs at all locations (moderate effect size, between-groups differences from 89.5 to 186.5kPa), a higher decrease in pain intensity at rest (large effect, difference 1.7, 95%CI 0.4 to 3.0) and improvements in sensitivity to light touch (moderate effect, difference -0.7, 95%CI -1.3 to -0.1) and in manual dexterity (large effect, difference 7.7, 95%CI 4.0 to 11.4seconds) than those that did not receive the neurodynamic intervention.
CONCLUSIONS


The inclusion of neural mobilization into a multimodal management approach resulted in reduction of pressure sensitivity, greater reduction in pain and improvement in sensitivity to light touch and manual dexterity in MS. Further studies are necessary to confirm these findings at longer term follow-ups. (ClinicalTrials.gov: NCT03595631).",2021,"The inclusion of neural mobilization into a multimodal management approach resulted in reduction of pressure sensitivity, greater reduction in pain and improvement in sensitivity to light touch and manual dexterity in MS.","['Thirty-two individuals with MS', 'individuals with multiple sclerosis (MS) with upper extremity pain symptoms', 'patients with multiple sclerosis', 'Tertiary hospital center']","['multimodal usual care alone (n=16) or multimodal usual care plus neurodynamic intervention', 'neurodynamic interventions', 'neurodynamic intervention', 'bilateral neurodynamic slider interventions targeting the upper extremity nerve trunks']","['PPTs', 'sensitivity to light touch', 'pain sensitivity and function', 'pain and improvement in sensitivity to light touch and manual dexterity in MS', 'manual dexterity', 'Pressure pain thresholds (PPTs) at the radial, median and ulnar nerve trunks, second metacarpal and tibialis anterior, pain intensity in the upper extremity (NPRS, 0-10), light touch detection threshold (von Frey hairs) and manual dexterity (nine-hole peg test', 'pain intensity']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1005353', 'cui_str': 'Trachemys'}, {'cui': 'C1282341', 'cui_str': 'Peripheral nerve structure of upper limb'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0085636', 'cui_str': 'Photophobia'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0041602', 'cui_str': 'Structure of ulnar nerve'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0025526', 'cui_str': 'Metacarpal bone structure'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0423553', 'cui_str': 'Light touch'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0162473', 'cui_str': 'Auriculotemporal syndrome'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}]",32.0,0.104081,"The inclusion of neural mobilization into a multimodal management approach resulted in reduction of pressure sensitivity, greater reduction in pain and improvement in sensitivity to light touch and manual dexterity in MS.","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'de Dios Pérez-Bruzón', 'Affiliation': 'Servicio Madrileño de Salud (SERMAS), Madrid, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain; Cátedra de Investigación y Docencia en Fisioterapia: Terapia Manual y Punción Seca, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain. Electronic address: cesar.fernandez@urjc.es.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': 'Doctor of Physical Therapy Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, Mass.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Plaza-Manzano', 'Affiliation': 'Department of Radiology, Rehabilitation and Physiotherapy, Universidad Complutense de Madrid, Madrid, Spain; Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ortega-Santiago', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain; Cátedra de Investigación y Docencia en Fisioterapia: Terapia Manual y Punción Seca, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain.'}]",Physiotherapy,['10.1016/j.physio.2021.04.004']
1791,35093699,Early relapse detection by monitoring of circulating cell-free DNA in patients with localized head and neck squamous cell carcinoma: A subgroup analysis of the multicenter randomized clinical trial IMSTAR-HN.,,2022,,['patients with localized head and neck squamous cell carcinoma'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}]",[],[],,0.317198,,"[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Jonas', 'Affiliation': 'Department of Internal Medicine IV, University Hospital Halle, Martin-Luther University Halle-Wittenberg, Germany.'}, {'ForeName': 'Donjete', 'Initials': 'D', 'LastName': 'Simnica', 'Affiliation': 'Department of Internal Medicine IV, University Hospital Halle, Martin-Luther University Halle-Wittenberg, Germany.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Bußmann', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Mildred Scheel Cancer Career Center HaTriCS4, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Henrike', 'Initials': 'H', 'LastName': 'Zech', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Doescher', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Ulm, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Laban', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Ulm, Germany.'}, {'ForeName': 'Chia-Jung', 'Initials': 'CJ', 'LastName': 'Busch', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University Medicine Greifswald, Germany; Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: chia-jung.busch@med.uni-greifswald.de.'}, {'ForeName': 'Mascha', 'Initials': 'M', 'LastName': 'Binder', 'Affiliation': 'Department of Internal Medicine IV, University Hospital Halle, Martin-Luther University Halle-Wittenberg, Germany. Electronic address: Mascha.Binder@uk-halle.de.'}]",Oral oncology,['10.1016/j.oraloncology.2022.105733']
1792,35093682,Budget impact of the Oncotype DX® test compared to other gene expression tests in patients with early breast cancer in Germany.,"PURPOSE


Gene expression tests can inform decisions on whether to recommend chemotherapy for patients with HR+, HER2- early breast cancer. The goal of this analysis was to compare treatment costs by an expanded budget impact model of reimbursed gene expression tests in Germany.
METHODS


A cost comparison was constructed as an expanded budget impact model to calculate average total costs per patient covered by public health insurance. Based on the strong clinical evidence from the prospective randomized controlled trial TAILORx including more than 10,000 patients with HR+ and node negative breast cancer, the assumption was made that the Oncotype DX® test accurately predicts chemotherapy benefit and clinical outcomes. For the further reimbursed tests (EndoPredict®, MammaPrint®, Prosigna®), results from comparative studies - aligned with prognosis studies - as analyzed in IQWiG Rapid Report D19-01 were applied.
RESULTS


The use of the Oncotype DX test led to estimated average savings per patient of 2,500 € vs. EndoPredict, 1,936 € vs. MammaPrint, and 649 € vs. Prosigna. Savings were achieved by reduction of unnecessary chemotherapy use, a consequence of false-positive test results (EndoPredict 73%, MammaPrint 42%, Prosigna 20%). False-negative test results (EndoPredict 5%, MammaPrint 22%, Prosigna 49%) reduced necessary chemotherapies, which initially results in cost savings, but may lead to increased long-term costs associated with management of progressive disease.
CONCLUSION


The results from this model suggest that the use of the Oncotype DX test reduces the cost of health care in Germany making it the most cost effective test compared to the further tests.",2022,The results from this model suggest that the use of the Oncotype DX test reduces the cost of health care in Germany making it the most cost effective test compared to the further tests.,"['patients with early breast cancer in Germany', 'patients with HR+, HER2- early breast cancer', 'Germany', '10,000 patients with HR+ and node negative breast cancer']",['Oncotype DX® test'],['cost of health care'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",,0.0290285,The results from this model suggest that the use of the Oncotype DX test reduces the cost of health care in Germany making it the most cost effective test compared to the further tests.,"[{'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Lux', 'Affiliation': 'Kooperatives Brustzentrum Paderborn, Frauenklinik St. Louise, Paderborn, St. Josefs-Krankenhaus, Salzkotten, Frauen- und Kinderklinik St. Louise, Paderborn, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Minartz', 'Affiliation': 'Institute for Health- and Pharmacoeconomics (IfGPh), Munich, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Müller-Huesmann', 'Affiliation': 'Kooperatives Brustzentrum Paderborn, Klinik für Hämatologie und Onkologie, Brüderkrankenhaus St. Josef, MVZ im MediCo, Paderborn, Germany.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Sandor', 'Affiliation': 'Kooperatives Brustzentrum Paderborn, Frauenklinik St. Louise, Paderborn, St. Josefs-Krankenhaus, Salzkotten, Frauen- und Kinderklinik St. Louise, Paderborn, Germany.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Herrmann', 'Affiliation': 'Exact Sciences GmbH Germany, Cologne Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Radeck-Knorre', 'Affiliation': 'Institute for Health- and Pharmacoeconomics (IfGPh), Munich, Germany.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Neubauer', 'Affiliation': 'Institute for Health- and Pharmacoeconomics (IfGPh), Munich, Germany. Electronic address: aljoscha.neubauer@ifgph-muenchen.de.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2022.100519']
1793,35093678,"Cognitive impairment networks in Alzheimer's disease: Analysis of three double-blind randomized, placebo-controlled, clinical trials of donepezil.","Psychometric network analysis is an alternative theoretically-driven analytic approach that has the potential to conceptualize cognitive impairment in Alzheimer's disease differently than was previously assumed and consequently detect unknown treatment effects. Based on individual participant data, extracted from three double-blind, randomized placebo-controlled clinical trials, psychometric networks were computed on observed Alzheimer's Disease Assessment Scale Cognitive Subscale scores at baseline (N=1,554) and on predicted change scores at 24 weeks of follow-up for participants who received donepezil (N=797) or placebo (N=484). A novel conceptualization of cognitive impairment in Alzheimer's disease was displayed through the baseline network, that had 90% (n=27) positive statistically significant (p<0.05) associations, and a most central aspect of ideational praxis. Following 24 weeks, treatment effects emerged via the differences between the change score networks. The donepezil network had more statistically significant (p<0.05) positive associations and a higher global strength (n=15; S=1.22; p=0.03), than the placebo network (n=8; S=0.57). This suggests that for those who were treated with donepezil compared with placebo, cognition is a more unified construct. The main aspects of change in cognitive impairment were comprehension of spoken language for the donepezil network and spoken language ability for the placebo network. Comprehension of spoken language apears to be most sensitive to psychopharmaceutical interventions and should therefore be closely monitored. Overall, our psychometric network analysis presents a new conceptualization of cognitive impairment in Alzheimer's disease, points to previously unknown treatment effects and highlights well-defined aspects of cognitive impairment  that may translate into future treatment targets.",2022,"The donepezil network had more statistically significant (p<0.05) positive associations and a higher global strength (n=15; S=1.22; p=0.03), than the placebo network (n=8; S=0.57).","[""Alzheimer's disease""]","['placebo', 'donepezil']","['global strength', 'Cognitive impairment networks', ""observed Alzheimer's Disease Assessment Scale Cognitive Subscale scores""]","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",,0.869107,"The donepezil network had more statistically significant (p<0.05) positive associations and a higher global strength (n=15; S=1.22; p=0.03), than the placebo network (n=8; S=0.57).","[{'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Rotstein', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: anat.rotstein@mssm.edu.'}, {'ForeName': 'Stephen Z', 'Initials': 'SZ', 'LastName': 'Levine', 'Affiliation': 'Department of Community Mental Health, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Myrto', 'Initials': 'M', 'LastName': 'Samara', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Technical University of Munich, School of Medicine, Munich, Germany; Department of Psychiatry, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Kazufumi', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Health Promotion and Human Behavior, Graduate School of Medicine/ School of Public Health, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Goldberg', 'Affiliation': 'Faculty of Industrial Engineering and Management, Technion Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cipriani', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Iwatsubo', 'Affiliation': 'Graduate School of Medicine, University of Tokyo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Leucht', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Technical University of Munich, School of Medicine, Munich, Germany.'}, {'ForeName': 'Toshiaki A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Department of Health Promotion and Human Behavior, Graduate School of Medicine/ School of Public Health, Kyoto University, Kyoto, Japan.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2022.01.001']
1794,35093666,Effects of assistive insole feedback training on immediate and multi-day partial weight bearing retention during walking: A pilot study.,"BACKGROUND


Adherence to partial weight bearing (PWB) plays a crucial role in early rehabilitation and motor control. Dynamic biofeedback insole systems provide a supportive function on immediate PWB adherence, while important long-term retention effects and potential advantages to a conventional static training remain unknown.
RESEARCH QUESTION


Is acoustic insole feedback training effective for the retention of prescribed PWB adherence and is there any advantage relative to static training using a conventional bathroom scale? Methods Twenty-four volunteers were randomized into two groups receiving biofeedback training (N = 12) via a mobile insole system (Loadsol®) or conventional training using a bathroom scale (N = 12). After initial PWB training (20 kg) of one randomized leg, the immediate and one-week retention effects were analysed using mean and maximum load (N) and overload rate (%). Statistical analysis was performed using a two-way repeated measures ANOVA with post-hoc pairwise comparisons (p < 0.05).
RESULTS


A significantly (p < 0.001) improved immediate and long-term PWB adherence was found for the insole feedback group during walking. A significant (p < 0.001) reduction of the overload rate by 86% was found for the insole feedback group when compared to the conventional training group after one week. Significant (p < 0.01) reductions by 51% and 46% was also found for the mean and maximum load in the insole feedback group when compared to the conventional training group.
SIGNIFICANCE


The use of insole feedback systems can serve as a viable tool to become familiar with PWB and to provide optimal retention of specified loads. Therefore, such systems serve as an advantageous training intervention to maintain a prescribed PWB during locomotion.",2022,"Significant (p < 0.01) reductions by 51% and 46% was also found for the mean and maximum load in the insole feedback group when compared to the conventional training group.
",[],"['biofeedback training (N\xa0=\xa012) via a mobile insole system (Loadsol®) or conventional training', 'assistive insole feedback training']","['mean and maximum load (N) and overload rate', 'immediate and long-term PWB adherence', 'overload rate']",[],"[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",24.0,0.00732531,"Significant (p < 0.01) reductions by 51% and 46% was also found for the mean and maximum load in the insole feedback group when compared to the conventional training group.
","[{'ForeName': 'Janina Anna', 'Initials': 'JA', 'LastName': 'Müßig', 'Affiliation': 'Institute for Biomechanics, Berufsgenossenschaftliche Unfallklinik Murnau, Murnau, Germany; Institute for Biomechanics, Paracelsus Medical Private University, Salzburg, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Brand', 'Affiliation': 'Institute for Biomechanics, Berufsgenossenschaftliche Unfallklinik Murnau, Murnau, Germany; Institute for Biomechanics, Paracelsus Medical Private University, Salzburg, Austria. Electronic address: andreas.brand@bgu-murnau.de.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Kröger', 'Affiliation': 'Institute for Biomechanics, Berufsgenossenschaftliche Unfallklinik Murnau, Murnau, Germany; Institute for Biomechanics, Paracelsus Medical Private University, Salzburg, Austria.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Klöpfer-Krämer', 'Affiliation': 'Institute for Biomechanics, Berufsgenossenschaftliche Unfallklinik Murnau, Murnau, Germany; Institute for Biomechanics, Paracelsus Medical Private University, Salzburg, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Augat', 'Affiliation': 'Institute for Biomechanics, Berufsgenossenschaftliche Unfallklinik Murnau, Murnau, Germany; Institute for Biomechanics, Paracelsus Medical Private University, Salzburg, Austria.'}]",Gait & posture,['10.1016/j.gaitpost.2022.01.014']
1795,35090363,"The effects of psilocybin on cognitive and emotional functions in healthy participants: Results from a phase 1, randomised, placebo-controlled trial involving simultaneous psilocybin administration and preparation.","BACKGROUND


Psilocybin, a psychoactive serotonin receptor partial agonist, has been reported to acutely reduce clinical symptoms of depressive disorders. Psilocybin's effects on cognitive function have not been widely or systematically studied.
AIM


The aim of this study was to explore the safety of simultaneous administration of psilocybin to healthy participants in the largest randomised controlled trial of psilocybin to date. Primary and secondary endpoints assessed the short- and longer-term change in cognitive functioning, as assessed by a Cambridge Neuropsychological Test Automated Battery (CANTAB) Panel, and emotional processing scales. Safety was assessed via endpoints which included cognitive function, assessed by CANTAB global composite score, and treatment-emergent adverse event (TEAE) monitoring.
METHODS


In this phase 1, randomised, double-blind, placebo-controlled study, healthy participants ( n  = 89; mean age 36.1 years; 41 females, 48 males) were randomised to receive a single oral dose of 10 or 25 mg psilocybin, or placebo, administered simultaneously to up to six participants, with one-to-one psychological support - each participant having an assigned, dedicated therapist available throughout the session.
RESULTS


In total, 511 TEAEs were reported, with a median duration of 1.0 day; 67% of all TEAEs started and resolved on the day of administration. There were no serious TEAEs, and none led to study withdrawal. There were no clinically relevant between-group differences in CANTAB global composite score, CANTAB cognitive domain scores, or emotional processing scale scores.
CONCLUSIONS


These results indicate that 10 mg and 25 mg doses of psilocybin were generally well tolerated when given to up to six participants simultaneously and did not have any detrimental short- or long-term effects on cognitive functioning or emotional processing.
CLINICAL TRIAL REGISTRATION


EudraCT (https://www.clinicaltrialsregister.eu/) number: 2018-000978-30.",2022,"There were no clinically relevant between-group differences in CANTAB global composite score, CANTAB cognitive domain scores, or emotional processing scale scores.
","['healthy participants', 'healthy participants ( n \u2009=\u200989; mean age 36.1\u2009years; 41 females, 48 males']","['placebo', 'Psilocybin', 'psilocybin, or placebo, administered simultaneously to up to six participants, with one-to-one psychological support - each participant having an assigned, dedicated therapist available throughout the session', 'psilocybin', 'psilocybin administration and preparation']","['cognitive and emotional functions', 'cognitive functioning or emotional processing', 'short- and longer-term change in cognitive functioning, as assessed by a Cambridge Neuropsychological Test Automated Battery (CANTAB) Panel, and emotional processing scales', 'cognitive function', 'cognitive function, assessed by CANTAB global composite score, and treatment-emergent adverse event (TEAE) monitoring', 'CANTAB global composite score, CANTAB cognitive domain scores, or emotional processing scale scores']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4505411', 'cui_str': 'CANTAB'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",511.0,0.566414,"There were no clinically relevant between-group differences in CANTAB global composite score, CANTAB cognitive domain scores, or emotional processing scale scores.
","[{'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Rucker', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Marwood', 'Affiliation': 'COMPASS Pathways PLC, London, UK.'}, {'ForeName': 'Riikka-Liisa J', 'Initials': 'RJ', 'LastName': 'Ajantaival', 'Affiliation': 'Clinical Research Institute, Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bird', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eriksson', 'Affiliation': 'COMPASS Pathways PLC, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Harrison', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Lennard-Jones', 'Affiliation': 'COMPASS Pathways PLC, London, UK.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Mistry', 'Affiliation': 'COMPASS Pathways PLC, London, UK.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Saldarini', 'Affiliation': 'COMPASS Pathways PLC, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stansfield', 'Affiliation': 'COMPASS Pathways PLC, London, UK.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Tai', 'Affiliation': 'Division of Psychology & Mental Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'COMPASS Pathways PLC, London, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Weston', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Malievskaia', 'Affiliation': 'COMPASS Pathways PLC, London, UK.'}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}]","Journal of psychopharmacology (Oxford, England)",['10.1177/02698811211064720']
1796,35110688,Adolescents are more sensitive than adults to acute behavioral and cognitive effects of THC.,"Increased cannabis availability has contributed to increased use with concomitant incidence of adverse effects. One risk factor for adverse drug reactions may be age. There is preclinical evidence that acute effects of delta-9-tetrahydrocannabinol (THC), the primary active constituent of cannabis, are greater during adolescence, but this has not been fully studied in humans. The present study sought to determine whether adolescent men and women are more sensitive than adults to acute THC. Adolescents aged 18-20 (N = 12) and adults aged 30-40 (N = 12), with less than 20 total lifetime uses of THC-containing products, received capsules of THC (7.5, 15 mg) and placebo across three study sessions in randomized order under double blind conditions. During each session, subjective, cardiovascular, behavioral, and EEG measures were obtained. Behavioral measures included Simple Reaction Time, Stop Task, Time Production and N-back and EEG measures included P300 amplitudes during an auditory oddball task and eyes-closed resting state. THC affected subjective state and heart rate similarly in both age groups. However, adolescents were more sensitive to performance impairing effects, exhibiting dose-dependent impairments on reaction time, response accuracy, and time perception. On EEG measures, THC dose-dependently decreased P300 amplitude in adolescents but not adults. Adolescents were more sensitive to behavioral and cognitive effects of THC, but not to cardiovascular effects or subjective measures. Thus, at doses that produce comparable ratings of intoxication, adolescents may exhibit greater cognitive impairment and alterations in brain function.",2022,"However, adolescents were more sensitive to performance impairing effects, exhibiting dose-dependent impairments on reaction time, response accuracy, and time perception.","['Adolescents aged 18-20 (N\u2009=\u200912) and adults aged 30-40 (N\u2009=\u200912), with less than 20 total lifetime uses of THC-containing products, received capsules of', 'adolescent men and women are more sensitive than adults to acute THC']","['placebo', 'delta-9-tetrahydrocannabinol', 'THC']","['subjective state and heart rate', 'Simple Reaction Time, Stop Task, Time Production and N-back and EEG measures included P300 amplitudes during an auditory oddball task and eyes-closed resting state', 'subjective, cardiovascular, behavioral, and EEG measures', 'P300 amplitude', 'reaction time, response accuracy, and time perception']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0040226', 'cui_str': 'Time Perception'}]",,0.0452253,"However, adolescents were more sensitive to performance impairing effects, exhibiting dose-dependent impairments on reaction time, response accuracy, and time perception.","[{'ForeName': 'Conor H', 'Initials': 'CH', 'LastName': 'Murray', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841\u2009S Maryland Ave, Chicago, IL, 60637, USA.'}, {'ForeName': 'Zhengyi', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841\u2009S Maryland Ave, Chicago, IL, 60637, USA.'}, {'ForeName': 'Royce', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841\u2009S Maryland Ave, Chicago, IL, 60637, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841\u2009S Maryland Ave, Chicago, IL, 60637, USA. hdew@uchicago.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-022-01281-w']
1797,35042152,"Final efficacy and safety data, and exploratory molecular profiling from the phase III ALUR study of alectinib versus chemotherapy in crizotinib-pretreated ALK-positive non-small-cell lung cancer.","BACKGROUND


At the primary data cut-off, the ALUR study demonstrated significantly improved progression-free survival (PFS) and central nervous system (CNS) objective response rate (ORR) with alectinib versus chemotherapy in pretreated, advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer. We report final efficacy and safety data, and exploratory molecular profiling.
PATIENTS AND METHODS


Patients who received prior platinum-doublet chemotherapy and crizotinib were randomized 2 : 1 to receive alectinib 600 mg twice daily (n = 79) or chemotherapy (pemetrexed 500 mg/m 2  or docetaxel 75 mg/m 2 , every 3 weeks; n = 40) until progressive disease, death or withdrawal. The primary endpoint was investigator-assessed PFS. Secondary endpoints included ORR, CNS ORR and safety. Plasma samples were collected at baseline, then every 6 weeks until progressive disease; molecular factors detected by next-generation sequencing were correlated with outcomes.
RESULTS


Investigator-assessed PFS was significantly longer with alectinib than chemotherapy (median 10.9 versus 1.4 months; hazard ratio 0.20, 95% confidence interval 0.12-0.33; P < 0.001). ORR was 50.6% with alectinib versus 2.5% with chemotherapy (P < 0.001). In patients with measurable CNS metastases at baseline, CNS ORR was 66.7% with alectinib versus 0% with chemotherapy (P < 0.001). No new safety signals were seen. ALK rearrangement was identified in 69.5% (n = 41/59) of baseline plasma samples. Confirmed partial responses were observed with alectinib in 6/11 patients with a secondary ALK mutation and 4/6 patients with a non-EML4-ALK (where EML4 is echinoderm microtubule-associated protein-like 4) fusion. Detection of mutant TP53 in baseline plasma resulted in numerically shorter PFS with alectinib (hazard ratio 1.88, 95% confidence interval 0.9-3.93).
CONCLUSIONS


Final efficacy data from ALUR confirmed the superior PFS, ORR and CNS ORR of alectinib versus chemotherapy in pretreated, advanced ALK-positive non-small-cell lung cancer. Alectinib prolonged PFS versus chemotherapy in patients with wild-type or mutant TP53; however, alectinib activity was considerably decreased in patients with mutant TP53.",2022,"Detection of mutant TP53 in baseline plasma resulted in numerically shorter PFS with alectinib (hazard ratio 1.88, 95% confidence interval 0.9-3.93).
","['Patients who received prior platinum-doublet chemotherapy and crizotinib', 'crizotinib-pretreated ALK-positive non-small-cell lung cancer', 'patients with wild-type or mutant TP53']","['alectinib versus chemotherapy', 'alectinib 600 mg twice daily (n\xa0= 79) or chemotherapy (pemetrexed 500 mg/m 2  or docetaxel', 'Alectinib prolonged PFS versus chemotherapy']","['superior PFS, ORR and CNS ORR', 'alectinib activity', 'CNS ORR', 'progression-free survival (PFS) and central nervous system (CNS) objective response rate (ORR', 'PFS', 'ALK rearrangement', 'investigator-assessed PFS', 'ORR, CNS ORR and safety', 'ORR', 'Plasma samples']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C0252409', 'cui_str': 'ALK Tyrosine Kinase Receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}]","[{'cui': 'C3853921', 'cui_str': 'alectinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C3853921', 'cui_str': 'alectinib'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0252409', 'cui_str': 'ALK Tyrosine Kinase Receptor'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}]",,0.398898,"Detection of mutant TP53 in baseline plasma resulted in numerically shorter PFS with alectinib (hazard ratio 1.88, 95% confidence interval 0.9-3.93).
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Å', 'Initials': 'Å', 'LastName': 'Helland', 'Affiliation': 'Department of Cancer Genetics and Department of Oncology, Institute for Cancer Research, Oslo University Hospital, University of Oslo, Oslo, Norway.'}, {'ForeName': 'I-J', 'Initials': 'IJ', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Chonnam National University Medical School, Hwasun-gun Jeollanam-do, Republic of Korea.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Migliorino', 'Affiliation': 'Pulmonary Oncology Unit, Azienda Ospedaliera San Camillo Forlanini Hospital, Rome, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dziadziuszko', 'Affiliation': 'Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wrona', 'Affiliation': 'Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'de Castro', 'Affiliation': 'Department of Medical Oncology, La Paz University Hospital, IdiPAZ, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Department of Pneumology, Toulouse University Hospital, Paul Sabatier University, Toulouse, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Griesinger', 'Affiliation': 'Department of Hematology and Oncology, Pius Hospital, University Medicine Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chlistalla', 'Affiliation': 'F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cardona', 'Affiliation': 'F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ruf', 'Affiliation': 'F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Trunzer', 'Affiliation': 'F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Smoljanovic', 'Affiliation': 'F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'Department of Oncology, University of Turin, Orbassano, Italy. Electronic address: silvia.novello@unito.it.'}]",ESMO open,['10.1016/j.esmoop.2021.100333']
1798,35045155,Comparison of four surgical approaches for rectal prolapse: multicentre randomized clinical trial.,"BACKGROUND


Several different procedures have been described for surgical treatment of rectal prolapse and consensus on the optimal approach has not been reached. The Swedish Rectal Prolapse Trial was performed with the aim to compare the outcomes after the most common surgical approaches to rectal prolapse.
METHOD


A multicentre randomized trial was conducted from 2000 to 2009. Patients were randomized between a perineal or an abdominal approach for correction of rectal prolapse (randomization A) if eligible for any procedures. Patients considered unsuitable for random allocation were only included in randomizations B or C. Patients in randomization B (perineal group) were randomized to Delorme's or Altemeier's procedures and those in randomization C (abdominal group) to suture rectopexy or resection rectopexy. Primary outcomes were bowel function and quality of life, measured using Wexner incontinence score and RAND-36, and secondary outcomes were complications and recurrence at 3 years.
RESULTS


During the study period, 134 patients were randomized: 18 in randomization A group, 80 in randomization B group and 54 in randomization C group; of these, 122 patients underwent surgery. Mean follow-up was 2.6 years. Improvements in Wexner and RAND-36 scores were seen but with no significant difference between the groups. Health change scores were significantly improved from baseline up to 1 year after surgery (P < 0.001). At 3 years, recurrence rates were two of seven patients for abdominal versus five of eight patients for perineal approach (P = 0.315), 18 of 31 patients (58 per cent) for Delorme's versus 15 of 30 patients (50 per cent) for Altemeier's (P = 0.611) and four of 19 patients (21 per cent) for suture rectopexy versus two of 21 patients (10 per cent) for resection rectopexy (P = 0.398). There were no significant differences regarding postoperative complications.
CONCLUSION


For all procedures, significant improvements from baseline in health change scores were noted after surgery. Recurrence rates were higher than previously reported. Registration number: NCT04893642 (http://www.clinicaltrials.gov).",2022,Health change scores were significantly improved from baseline up to 1 year after surgery (P < 0.001).,"['2000 to 2009', '134 patients were randomized: 18 in randomization A group, 80 in randomization B group and 54 in randomization C group; of these, 122 patients underwent surgery', 'rectal prolapse']","['perineal or an abdominal approach for correction of rectal prolapse', ""Delorme's or Altemeier's procedures and those in randomization C (abdominal group) to suture rectopexy or resection rectopexy""]","['Wexner and RAND-36 scores', 'postoperative complications', 'Recurrence rates', 'recurrence rates', 'health change scores', 'bowel function and quality of life, measured using Wexner incontinence score and RAND-36, and secondary outcomes were complications and recurrence at 3 years', 'Health change scores']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034888', 'cui_str': 'Rectal prolapse'}]","[{'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach'}, {'cui': 'C0034888', 'cui_str': 'Rectal prolapse'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0193176', 'cui_str': 'Proctopexy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439234', 'cui_str': 'year'}]",134.0,0.280288,Health change scores were significantly improved from baseline up to 1 year after surgery (P < 0.001).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Smedberg', 'Affiliation': 'Department of Clinical Sciences at Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Graf', 'Affiliation': 'Department of Surgical Sciences, Section of Surgery, Akademiska Sjukhuset, Uppsala, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Pekkari', 'Affiliation': 'Department of Clinical Sciences at Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Hjern', 'Affiliation': 'Department of Clinical Sciences at Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}]",BJS open,['10.1093/bjsopen/zrab140']
1799,35098177,"Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial.","Background


Safe and effective vaccines are urgently needed to end the COVID-19 pandemic caused by SARS-CoV-2 infection. We aimed to assess the preliminary safety, tolerability, and immunogenicity of an mRNA vaccine ARCoV, which encodes the SARS-CoV-2 spike protein receptor-binding domain (RBD).
Methods


This single centre, double-blind, randomised, placebo-controlled, dose-escalation, phase 1 trial of ARCoV was conducted at Shulan (Hangzhou) hospital in Hangzhou, Zhejiang province, China. Healthy adults aged 18-59 years negative for SARS-CoV-2 infection were enrolled and randomly assigned using block randomisation to receive an intramuscular injection of vaccine or placebo. Vaccine doses were 5 μg, 10 μg, 15 μg, 20 μg, and 25 μg. The first six participants in each block were sentinels and along with the remaining 18 participants, were randomly assigned to groups (5:1). In block 1 sentinels were given the lowest vaccine dose and after a 4-day observation with confirmed safety analyses, the remaining 18 participants in the same dose group proceeded and sentinels in block 2 were given their first administration on a two-dose schedule, 28 days apart. All participants, investigators, and staff doing laboratory analyses were masked to treatment allocation. Humoral responses were assessed by measuring anti-SARS-CoV-2 RBD IgG using a standardised ELISA and neutralising antibodies using pseudovirus-based and live SARS-CoV-2 neutralisation assays. SARS-CoV-2 RBD-specific T-cell responses, including IFN-γ and IL-2 production, were assessed using an enzyme-linked immunospot (ELISpot) assay. The primary outcome for safety was incidence of adverse events or adverse reactions within 60 min, and at days 7, 14, and 28 after each vaccine dose. The secondary safety outcome was abnormal changes detected by laboratory tests at days 1, 4, 7, and 28 after each vaccine dose. For immunogenicity, the secondary outcome was humoral immune responses: titres of neutralising antibodies to live SARS-CoV-2, neutralising antibodies to pseudovirus, and RBD-specific IgG at baseline and 28 days after first vaccination and at days 7, 15, and 28 after second vaccination. The exploratory outcome was SARS-CoV-2-specific T-cell responses at 7 days after the first vaccination and at days 7 and 15 after the second vaccination. This trial is registered with www.chictr.org.cn (ChiCTR2000039212).
Findings


Between Oct 30 and Dec 2, 2020, 230 individuals were screened and 120 eligible participants were randomly assigned to receive five-dose levels of ARCoV or a placebo (20 per group). All participants received the first vaccination and 118 received the second dose. No serious adverse events were reported within 56 days after vaccination and the majority of adverse events were mild or moderate. Fever was the most common systemic adverse reaction (one [5%] of 20 in the 5 μg group, 13 [65%] of 20 in the 10 μg group, 17 [85%] of 20 in the 15 μg group, 19 [95%] of 20 in the 20 μg group, 16 [100%] of 16 in the 25 μg group; p<0·0001). The incidence of grade 3 systemic adverse events were none (0%) of 20 in the 5 μg group, three (15%) of 20 in the 10 μg group, six (30%) of 20 in the 15 μg group, seven (35%) of 20 in the 20 μg group, five (31%) of 16 in the 25 μg group, and none (0%) of 20 in the placebo group (p=0·0013). As expected, the majority of fever resolved in the first 2 days after vaccination for all groups. The incidence of solicited systemic adverse events was similar after administration of ARCoV as a first or second vaccination. Humoral immune responses including anti-RBD IgG and neutralising antibodies increased significantly 7 days after the second dose and peaked between 14 and 28 days thereafter. Specific T-cell response peaked between 7 and 14 days after full vaccination. 15 μg induced the highest titre of neutralising antibodies, which was about twofold more than the antibody titre of convalescent patients with COVID-19.
Interpretation


ARCoV was safe and well tolerated at all five doses. The acceptable safety profile, together with the induction of strong humoral and cellular immune responses, support further clinical testing of ARCoV at a large scale.
Funding


National Key Research and Development Project of China, Academy of Medical Sciences China, National Natural Science Foundation China, and Chinese Academy of Medical Sciences.",2022,Humoral immune responses including anti-RBD IgG and neutralising antibodies increased significantly 7 days after the second dose and peaked between 14 and 28 days thereafter.,"['Healthy adults aged 18-59 years negative for SARS-CoV-2 infection', 'Chinese adults', 'Findings\n\n\nBetween Oct 30 and Dec 2, 2020, 230 individuals were screened and 120 eligible participants']","['placebo', 'ARCoV or a placebo', 'SARS-CoV-2 ARCoV mRNA vaccine', 'vaccine or placebo']","['safe and well tolerated', 'systemic adverse reaction', 'solicited systemic adverse events', 'Safety and immunogenicity', 'highest titre of neutralising antibodies', 'SARS-CoV-2 RBD-specific T-cell responses, including IFN-γ and IL-2 production', 'SARS-CoV-2-specific T-cell responses', 'safety was incidence of adverse events or adverse reactions', 'Humoral immune responses including anti-RBD IgG and neutralising antibodies', 'Specific T-cell response', 'incidence of grade 3 systemic adverse events', 'humoral immune responses: titres of neutralising antibodies to live SARS-CoV-2, neutralising antibodies to pseudovirus, and RBD-specific IgG', 'Humoral responses', 'serious adverse events']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]",230.0,0.554257,Humoral immune responses including anti-RBD IgG and neutralising antibodies increased significantly 7 days after the second dose and peaked between 14 and 28 days thereafter.,"[{'ForeName': 'Gui-Ling', 'Initials': 'GL', 'LastName': 'Chen', 'Affiliation': 'Shulan (Hangzhou) Hospital, Hangzhou, China.'}, {'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Pathogen and Biosecurity, Beijing Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Xia-Hong', 'Initials': 'XH', 'LastName': 'Dai', 'Affiliation': 'Shulan (Hangzhou) Hospital, Hangzhou, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Shulan (Hangzhou) Hospital, Hangzhou, China.'}, {'ForeName': 'Meng-Li', 'Initials': 'ML', 'LastName': 'Cheng', 'Affiliation': 'State Key Laboratory of Pathogen and Biosecurity, Beijing Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Walvax Biotechnology, Kunming, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases/National Clinical Research Center for Infectious Diseases/Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yu-Hua', 'Initials': 'YH', 'LastName': 'Ge', 'Affiliation': 'Shulan (Hangzhou) Hospital, Hangzhou, China.'}, {'ForeName': 'Zhen-Wei', 'Initials': 'ZW', 'LastName': 'Shen', 'Affiliation': 'Zhejiang Shuren University Shulan International Medical College, Hangzhou, China.'}, {'ForeName': 'Yong-Qiang', 'Initials': 'YQ', 'LastName': 'Deng', 'Affiliation': 'State Key Laboratory of Pathogen and Biosecurity, Beijing Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Shu-Yuan', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'Walvax Biotechnology, Kunming, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Pathogen and Biosecurity, Beijing Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Na-Na', 'Initials': 'NN', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Pathogen and Biosecurity, Beijing Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Yi-Fei', 'Initials': 'YF', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Pathogen and Biosecurity, Beijing Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Suzhou Abogen Biosciences, Suzhou, China.'}, {'ForeName': 'Kai-Qi', 'Initials': 'KQ', 'LastName': 'Wu', 'Affiliation': 'Shulan (Hangzhou) Hospital, Hangzhou, China.'}, {'ForeName': 'Meng-Fei', 'Initials': 'MF', 'LastName': 'Zhu', 'Affiliation': 'Shulan (Hangzhou) Hospital, Hangzhou, China.'}, {'ForeName': 'Cong-Gao', 'Initials': 'CG', 'LastName': 'Peng', 'Affiliation': 'Shulan (Hangzhou) Hospital, Hangzhou, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Shulan (Hangzhou) Hospital, Hangzhou, China.'}, {'ForeName': 'Shou-Chun', 'Initials': 'SC', 'LastName': 'Cao', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Yu-Hua', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Dan-Hua', 'Initials': 'DH', 'LastName': 'Zhao', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Wu', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ni', 'Affiliation': 'Institute for Immunology and School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Hua-Hao', 'Initials': 'HH', 'LastName': 'Shen', 'Affiliation': 'Key Laboratory of Respiratory Disease of Zhejiang Province, Department of Respiratory and Critical Care Medicine, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'Institute for Immunology and School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Ying', 'Affiliation': 'Suzhou Abogen Biosciences, Suzhou, China.'}, {'ForeName': 'Guo-Ping', 'Initials': 'GP', 'LastName': 'Sheng', 'Affiliation': 'Shulan (Hangzhou) Hospital, Hangzhou, China.'}, {'ForeName': 'Cheng-Feng', 'Initials': 'CF', 'LastName': 'Qin', 'Affiliation': 'State Key Laboratory of Pathogen and Biosecurity, Beijing Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Hai-Nv', 'Initials': 'HN', 'LastName': 'Gao', 'Affiliation': 'Shulan (Hangzhou) Hospital, Hangzhou, China.'}, {'ForeName': 'Lan-Juan', 'Initials': 'LJ', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases/National Clinical Research Center for Infectious Diseases/Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}]",The Lancet. Microbe,['10.1016/S2666-5247(21)00280-9']
1800,35084893,Effects of family intervention on psychosocial functioning and mood symptoms of youth at high risk for bipolar disorder.,"OBJECTIVES


Family-focused therapy (FFT) is associated with reduced rates of mood episodes among youth at high risk for bipolar disorder (BD). In a randomized trial of FFT compared to a psychoeducation-only treatment (enhanced care, EC), we sought to determine if changes in psychosocial functioning mediate mood improvements among high-risk youth.
METHOD


119 youths with active mood symptoms and a family history of BD were randomized to either 4 months of FFT or EC. Participants were rated on mood symptom severity and provided self-ratings of psychosocial functioning across domains of family, social-emotional, and school functioning. Repeated measures mixed modeling and bootstrapped mediational analyses evaluated the effects of treatment conditions and psychosocial functioning on mood improvements immediately posttreatment and over 2 years of follow-up.
RESULTS


Youths in FFT reported greater improvements in family functioning over 24 months compared to those in EC,  F (5, 76.8) = 3.1,  p  < .05. Improvements in family functioning partially mediated participants' improvements in depressive symptoms,  B  = -0.22,  p  < .01; 95% CI [-0.55, -0.02]. The effects of FFT versus EC on family functioning were stronger among youth with comorbid anxiety and externalizing disorders than among youth without these comorbid disorders.
CONCLUSIONS


The findings suggest a temporal link between changes in youths' perceptions of family functioning and improvements in depressive symptoms among high-risk youth in FFT. Family conflict and cohesion are important treatment targets for youth who present with early signs of BD. Future studies should examine whether changes in observational measures of family interaction precede improvements in mood among high-risk youth. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,"RESULTS


Youths in FFT reported greater improvements in family functioning over 24 months compared to those in EC,  F (5, 76.8) = 3.1,  p  < .05.","['youth who present with early signs of BD', 'youth at high risk for bipolar disorder (BD', 'high-risk youth', '119 youths with active mood symptoms and a family history of BD', 'youth with comorbid anxiety and externalizing disorders than among youth without these comorbid disorders', 'youth at high risk for bipolar disorder']","['psychoeducation-only treatment (enhanced care, EC', 'FFT or EC', 'Family-focused therapy (FFT', 'FFT', 'FFT versus EC', 'family intervention']","['mood symptom severity and provided self-ratings of psychosocial functioning across domains of family, social-emotional, and school functioning', 'psychosocial functioning and mood symptoms', 'family functioning', 'depressive symptoms']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0455384', 'cui_str': 'FH: Manic-depressive state'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",119.0,0.106509,"RESULTS


Youths in FFT reported greater improvements in family functioning over 24 months compared to those in EC,  F (5, 76.8) = 3.1,  p  < .05.","[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Weintraub', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Schneck', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Posta', 'Affiliation': 'Department of Mathematics.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Merranko', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'Private Practice.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Department of Psychiatry.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000708']
1801,34998253,Cognitive training in recently-abstinent individuals with alcohol use disorder improves emotional stroop performance: Evidence from a randomized pilot trial.,"BACKGROUND


Cognitive training interventions appear capable of improving alcohol-associated neurobehavioral deficits in recently detoxified individuals. However, efficacy remains incompletely characterized in alcohol use disorder (AUD) and available data address only non-affective cognitive outcomes; enhancement of social cognition remains uninvestigated. We utilized a training paradigm in which successfully ignoring emotionally-valent stimuli benefitted task performance. We hypothesized trained individuals would display improvements in an affective inhibitory control task, and that individuals trained with high valence (relative to neutral) stimuli would evince greater improvement.
METHODS


42 recently detoxified inpatients with AUD were assigned to one of three groups (Emotional Training, Neutral Training, or Treatment as Usual [TAU]). Training consisted of two computerized working memory tasks (dual-modality n-back task; attend/ignore task) which included task-irrelevant stimuli (emotional vs. neutral). Post-training performance efficiency (indexing speed-accuracy tradeoffs) in an emotional Stroop task was the outcome of interest.
RESULTS


Significant group by time interactions were detected for emotional Stroop performance, supporting our hypothesis that trained groups would exhibit greater improvement than TAU controls (F[2,39]=8.61, p < .01). Additionally, the emotional training condition appeared to result in greater improvement relative to neutral training (F[1,26]=4.98, p < .01).
CONCLUSION


Results are consistent with current literature suggesting the potential of training to enhance cognitive recovery in early abstinence. Findings inform the development of training protocols, suggesting integration of task-irrelevant distractor stimuli in training may enhance cognitive control outcomes. Further, they expand the relevant domains for application of training approaches, providing novel evidence that among individuals with AUD, training-associated benefits may extend to social cognitive domains.",2022,"Additionally, the emotional training condition appeared to result in greater improvement relative to neutral training (F[1,26]=4.98, p < .01).
","['recently-abstinent individuals with alcohol use disorder', 'recently detoxified inpatients with AUD', '42']","['Training consisted of two computerized working memory tasks (dual-modality n-back task; attend/ignore task) which included task-irrelevant stimuli (emotional vs. neutral', 'Emotional Training, Neutral Training, or Treatment as Usual [TAU', 'Cognitive training', 'Cognitive training interventions']","['emotional stroop performance', 'emotional Stroop performance', 'improvement relative to neutral training']","[{'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",42.0,0.018323,"Additionally, the emotional training condition appeared to result in greater improvement relative to neutral training (F[1,26]=4.98, p < .01).
","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'University of Florida, Department of Psychiatry, Gainesville, FL, United States; University of Florida, Department of Psychology, Gainesville, FL, United States; University of Florida, Center for Addiction Research & Education, Gainesville, FL, United States. Electronic address: benlewis@ufl.edu.'}, {'ForeName': 'Christian C', 'Initials': 'CC', 'LastName': 'Garcia', 'Affiliation': 'University of Florida, Department of Psychiatry, Gainesville, FL, United States; University of Florida, Department of Psychology, Gainesville, FL, United States; University of Florida, Center for Addiction Research & Education, Gainesville, FL, United States.'}, {'ForeName': 'Julianne L', 'Initials': 'JL', 'LastName': 'Price', 'Affiliation': 'Rutgers University, Center of Alcohol & Substance Use Studies, New Brunswick, NJ, United States.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Schweizer', 'Affiliation': 'University of Cambridge, Department of Psychology, Cambridge, UK; University of New South Wales, School of Psychology, Sydney, Australia.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Nixon', 'Affiliation': 'University of Florida, Department of Psychiatry, Gainesville, FL, United States; University of Florida, Department of Psychology, Gainesville, FL, United States; University of Florida, Center for Addiction Research & Education, Gainesville, FL, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.109239']
1802,35092722,"Controlled-Level EVERolimus in Acute Coronary Syndrome (CLEVER-ACS) - A phase II, randomized, double-blind, multi-center, placebo-controlled trial.","BACKGROUND


Activation of inflammatory pathways during acute myocardial infarction contributes to infarct size and left ventricular (LV) remodeling. The present prospective randomized clinical trial was designed to test the efficacy and safety of broad-spectrum anti-inflammatory therapy with a mammalian target of rapamycin (mTOR) inhibitor to reduce infarct size.
DESIGN


Controlled-Level EVERolimus in Acute Coronary Syndrome (CLEVER-ACS, clinicaltrials.gov NCT01529554) is a phase II randomized, double-blind, multi-center, placebo-controlled trial on the effects of a 5-day course of oral everolimus on infarct size, LV remodeling, and inflammation in patients with acute ST-elevation myocardial infarction (STEMI). Within 5 days of successful primary percutaneous coronary intervention (pPCI), patients are randomly assigned to everolimus (first 3 days: 7.5 mg every day; days 4 and 5: 5.0 mg every day) or placebo, respectively. The primary efficacy outcome is the change from baseline (defined as 12 hours to 5 days after pPCI) to 30-day follow-up in myocardial infarct size as measured by cardiac magnetic resonance imaging (CMRI). Secondary endpoints comprise corresponding changes in cardiac and inflammatory biomarkers as well as microvascular obstruction and LV volumes assessed by CMRI. Clinical events, laboratory parameters, and blood cell counts are reported as safety endpoints at 30 days.
CONCLUSION


The CLEVER-ACS trial tests the hypothesis whether mTOR inhibition using everolimus at the time of an acute STEMI affects LV infarct size following successful pPCI.",2022,"Within 5 days of successful primary percutaneous coronary intervention (pPCI), patients are randomly assigned to everolimus (first 3 days: 7.5 mg qd; days 4 and 5: 5.0 mg qd) or placebo, respectively.","['Acute Coronary Syndrome (CLEVER-ACS) ', 'patients with acute ST-elevation myocardial infarction (STEMI']","['placebo', 'everolimus', 'Controlled-Level EVERolimus', 'broad-spectrum anti-inflammatory therapy with a mammalian target of rapamycin (mTOR) inhibitor', 'successful primary percutaneous coronary intervention (pPCI', 'oral everolimus', 'Level EVERolimus']","['changes in cardiac and inflammatory biomarkers as well as microvascular obstruction and LV volumes assessed by CMRI', 'efficacy and safety', 'infarct size, LV remodeling, and inflammation', 'Clinical events, laboratory parameters, and blood cell counts', '30-day follow-up in myocardial infarct size as measured by cardiac magnetic resonance imaging (CMRI']","[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1279682', 'cui_str': 'Clever'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0293060', 'cui_str': 'FKBP12-Rapamycin Associated Protein'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.723164,"Within 5 days of successful primary percutaneous coronary intervention (pPCI), patients are randomly assigned to everolimus (first 3 days: 7.5 mg qd; days 4 and 5: 5.0 mg qd) or placebo, respectively.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Klingenberg', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland; Department of Cardiology, Kerckhoff Heart and Thorax Center, and Campus of the Justus Liebig University of Giessen, Germany; DZHK (German Center for Cardiovascular Research), partner site Rhine-Main, Bad Nauheim, Germany.'}, {'ForeName': 'Barbara E', 'Initials': 'BE', 'LastName': 'Stähli', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland.'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'Clinical Trial Unit, Social and Preventive Medicine, University of Bern, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Denegri', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Manka', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Kapos', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'von Eckardstein', 'Affiliation': 'Department of Clinical Chemistry, University Hospital Zurich, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carballo', 'Affiliation': 'Department of Cardiology, Hopitaux Universitaires de Geneve, Geneva, Switzerland.'}, {'ForeName': 'Christian W', 'Initials': 'CW', 'LastName': 'Hamm', 'Affiliation': 'Department of Cardiology, Kerckhoff Heart and Thorax Center, and Campus of the Justus Liebig University of Giessen, Germany; DZHK (German Center for Cardiovascular Research), partner site Rhine-Main, Bad Nauheim, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Vietheer', 'Affiliation': 'Department of Cardiology, Kerckhoff Heart and Thorax Center, and Campus of the Justus Liebig University of Giessen, Germany; DZHK (German Center for Cardiovascular Research), partner site Rhine-Main, Bad Nauheim, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rolf', 'Affiliation': 'Department of Cardiology, Kerckhoff Heart and Thorax Center, and Campus of the Justus Liebig University of Giessen, Germany; DZHK (German Center for Cardiovascular Research), partner site Rhine-Main, Bad Nauheim, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland; Department of Cardiology, Charité - University Medicine, , Berlin, Germany.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Mach', 'Affiliation': 'Department of Cardiology, Hopitaux Universitaires de Geneve, Geneva, Switzerland.'}, {'ForeName': 'Tiziano', 'Initials': 'T', 'LastName': 'Moccetti', 'Affiliation': 'Department of Cardiology, Cardiocentro Ticino, Lugano, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jung', 'Affiliation': 'Division of Cardiology, Pulmonary Diseases and Vascular Medicine, University Hospital of Duesseldorf, Duesseldorf, Germany.'}, {'ForeName': 'Malte', 'Initials': 'M', 'LastName': 'Kelm', 'Affiliation': 'Division of Cardiology, Pulmonary Diseases and Vascular Medicine, University Hospital of Duesseldorf, Duesseldorf, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Münzel', 'Affiliation': 'Department of Cardiology, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Pedrazzini', 'Affiliation': 'Department of Cardiology, Cardiocentro Ticino, Lugano, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Räber', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Matter', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland; Center for Molecular Cardiology, University of Zurich, Schlieren, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ruschitzka', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Lüscher', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, Bern, Switzerland; Imperial College, National Heart and Lung Institute and Royal Brompton and Harefield Hospitals, Heart Division London, U.K.. Electronic address: cardio@tomluescher.ch.'}]",American heart journal,['10.1016/j.ahj.2022.01.010']
1803,35093596,"Combined spinal-epidural anesthesia with acupoint injection for labor anesthesia reduces IL-1β/IL-10 ratio in maternal peripheral blood, umbilical cord blood and improves the labor outcomes: A prospective randomized controlled trial.","BACKGROUND


This study aimed to investigate the effects of combined spinal-epidural anesthesia (CSEA) with acupoint injection (AI) on the maternal-fetal expression of interleukin-1β (IL-1β), interleukin-10 (IL-10), analgesia effect, and labor outcomes.
METHODS


A total of 360 healthy primiparas were randomized into the CSEA+AI group, the CSEA group, the AI group, and the control group (n = 90, each group) according to the labor analgesia methods.
RESULTS


Compared to the CSEA group, the CSEA+AI group had significantly lower visual analog scale (VAS) scores, adverse events, dose of ropivacaine/sufentanil, and shorter labor durations. The IL-1β/IL-10 ratio in maternal peripheral blood and umbilical cord blood was reduced in the CSEA+AI group compared with the CSEA group.
CONCLUSION


The combination of CSEA and AI can reduce the ratio of IL-1β/ IL-10 in maternal peripheral blood and umbilical cord blood, which can effectively relieve labor pain.",2022,"The IL-1β/IL-10 ratio in maternal peripheral blood and umbilical cord blood was reduced in the CSEA+AI group compared with the CSEA group.
",['360 healthy primiparas'],"['Combined spinal-epidural anesthesia with acupoint injection', 'CSEA', 'combined spinal-epidural anesthesia (CSEA) with acupoint injection (AI']","['IL-1β/IL-10 ratio in maternal peripheral blood and umbilical cord blood', 'maternal-fetal expression of interleukin-1β (IL-1β), interleukin-10 (IL-10), analgesia effect, and labor outcomes', 'visual analog scale (VAS) scores, adverse events, dose of ropivacaine/sufentanil, and shorter labor durations', 'IL-1β/IL-10 ratio in maternal peripheral blood, umbilical cord blood and improves the labor outcomes']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",360.0,0.201704,"The IL-1β/IL-10 ratio in maternal peripheral blood and umbilical cord blood was reduced in the CSEA+AI group compared with the CSEA group.
","[{'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, Guangdong, China. Electronic address: wulingling2003@163.com.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': ""Department of Gynecology, the First People's Hospital of Yunnan Province, the Affiliated Hospital of Kunming University of Science and Technology, Kunming 650034, Yunnan, China.""}, {'ForeName': 'Zijing', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, Guangdong, China.'}, {'ForeName': 'Minli', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynecology, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, Guangdong, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, Guangdong, China.'}, {'ForeName': 'Changping', 'Initials': 'C', 'LastName': 'Fang', 'Affiliation': 'Department of Obstetrics and Gynecology, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, Guangdong, China.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, Guangdong, China.'}, {'ForeName': 'Shangrong', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, Guangdong, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yi', 'Affiliation': 'Acupuncture-Moxibustion and Rehabilitation Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou 510006, Guangdong, China.'}, {'ForeName': 'Andong', 'Initials': 'A', 'LastName': 'Zhou', 'Affiliation': 'Department of Clinical Medicine, the Second Clinical Medical School of Guangdong Medical University, Dongguan 523808, Guangdong, China.'}]","Clinical immunology (Orlando, Fla.)",['10.1016/j.clim.2022.108935']
1804,34879374,Drug-Eluting versus Bare-Metal Stents in Saphenous Vein Grafts Compared to Native Coronary Vessels: The Norwegian Coronary Stent Trial Study.,"BACKGROUND


Drug-eluting stents (DES) reduce target lesion revascularization (TLR) with no effect on mortality or myocardial infarction (MI) compared to bare-metal stents (BMS) in native vessels. Randomized stent studies in saphenous vein grafts (SVG) are few and the reported effects are ambiguous. The Norwegian Coronary Stent Trial study is the first to randomize lesions to percutaneous coronary intervention in native vessels and SVG.
AIMS


The aim of this study was to compare the rate of mortality, MI, and TLR across stent and vessel types.
METHODS


In this substudy, 6,087 patients with a single lesion in native vessels and 164 in SVG were followed for 5 years.
RESULTS


MI was more frequent in SVG (subdistributional hazard ratio [SHR] 4.95 (3.75-6.54, p < 0.001), but not affected by stent type. In the first 500 days, DES reduced TLR in native vessels (SHR 0.21 (0.15-0.30) p < 0.001) and SVG (SHR 0.18 (0.04-0.80) p = 0.02). Thereafter, DES and BMS were equivalent in native vessels, but DES had a higher TLR rate than BMS in SVG (SHR 3.31 (1.23-8.94) p = 0.02). After 5 years, the TLR rate was still significantly lower for DES in native vessels (3.2% vs. 7.8%, p < 0.001) but not in SVG (21.4% vs. 18. 4%).
CONCLUSION


In SVG, no difference in TLR between DES and BMS was observed after 5 years in contrast to persistent benefit in native vessels. The high rate of TLR and MI in SVG makes treatment of native vessels a preference whenever feasible and better treatment options for SVG are warranted.",2022,"Thereafter, DES and BMS were equivalent in native vessels, but DES had a higher TLR rate than BMS in SVG (SHR 3.31 (1.23-8.94) p = 0.02).","['6,087 patients with a single lesion in native vessels and 164 in SVG were followed for 5 years']","['Saphenous Vein Grafts', 'percutaneous coronary intervention', 'Drug-Eluting versus Bare-Metal Stents', 'Drug-eluting stents (DES', 'saphenous vein grafts (SVG', 'bare-metal stents (BMS']","['rate of mortality, MI, and TLR across stent and vessel types', 'SVG', 'mortality or myocardial infarction (MI', 'DES reduced TLR in native vessels', 'TLR between DES and BMS', 'TLR rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0577304', 'cui_str': 'Single lesion'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}]",6087.0,0.0670584,"Thereafter, DES and BMS were equivalent in native vessels, but DES had a higher TLR rate than BMS in SVG (SHR 3.31 (1.23-8.94) p = 0.02).","[{'ForeName': 'Per Morten', 'Initials': 'PM', 'LastName': 'Mølstad', 'Affiliation': 'Department of Cardiology, LHL Clinics Gardermoen, Jessheim, Norway.'}, {'ForeName': 'Jan Erik', 'Initials': 'JE', 'LastName': 'Nordrehaug', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Terje K', 'Initials': 'TK', 'LastName': 'Steigen', 'Affiliation': 'Cardiovascular Research Group, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Wilsgaard', 'Affiliation': 'Department of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Wiseth', 'Affiliation': 'Clinic of Cardiology, St. Olavs University Hospital, Trondheim, Norway.'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Rotevatn', 'Affiliation': 'Department of Heart Disease, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mannsverk', 'Affiliation': 'Department of Cardiology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Larsen', 'Affiliation': 'Cardiological Department, Akershus University Clinic Gardermoen, Jessheim, Norway.'}, {'ForeName': 'Kristina Elisabet', 'Initials': 'KE', 'LastName': 'Larsby', 'Affiliation': 'Department of Cardiology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Sigrun Ådnegard', 'Initials': 'SÅ', 'LastName': 'Skarstad', 'Affiliation': 'Department of Cardiology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Eivind Øygard', 'Initials': 'EØ', 'LastName': 'Fosse', 'Affiliation': 'Department of Cardiology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Dahl-Eriksen', 'Affiliation': 'Department of Cardiology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Kaare Harald', 'Initials': 'KH', 'LastName': 'Bønaa', 'Affiliation': 'Clinic of Cardiology, St. Olavs University Hospital, Trondheim, Norway.'}]",Cardiology,['10.1159/000521085']
1805,35038479,Enhancing cognitive restructuring with concurrent fMRI-guided neurostimulation for emotional dysregulation-A randomized controlled trial.,"BACKGROUND


Transdiagnostic clinical emotional dysregulation is a key component of many mental health disorders and offers an avenue to address multiple disorders with one transdiagnostic treatment. In the current study, we pilot an intervention that combines a one-time teaching and practice of cognitive restructuring (CR) with repetitive transcranial magnetic stimulation (rTMS), targeted based on functional magnetic resonance imaging (fMRI).
METHODS


Thirty-seven clinical adults who self-reported high emotional dysregulation were enrolled in this randomized, double-blind, placebo-controlled trial. fMRI was collected as participants were reminded of lifetime stressors and asked to downregulate their distress using CR tactics. fMRI BOLD data were analyzed to identify the cluster of voxels within the left dorsolateral prefrontal cortex (dlPFC) with the highest activation when participants attempted to downregulate, versus passively remember, distressing memories. Participants underwent active or sham rTMS (10 Hz) over the left dlPFC target while practicing CR following emotional induction using recent autobiographical stressors.
RESULTS


Receiving active versus sham rTMS led to significantly higher high frequency heart rate variability during regulation, lower regulation duration during the intervention, and higher likelihood to use CR during the week following the intervention. There were no differences between conditions when administering neurostimulation alone without the CR skill and compared to sham. Participants in the sham versus active condition experienced less distress the week after the intervention. There were no differences between conditions at the one-month follow up.
CONCLUSION


This study demonstrated that combining active rTMS with emotion regulation training for one session significantly enhances emotion regulation and augments the impact of training for as long as a week. These findings are a promising step towards a combined intervention for transdiagnostic emotion dysregulation.",2022,"Receiving active versus sham rTMS led to significantly higher high frequency heart rate variability during regulation, lower regulation duration during the intervention, and higher likelihood to use CR during the week following the intervention.",['Thirty-seven clinical adults who self-reported high emotional dysregulation'],"['placebo', 'concurrent fMRI-guided neurostimulation', 'active or sham rTMS', 'cognitive restructuring (CR) with repetitive transcranial magnetic stimulation (rTMS), targeted based on functional magnetic resonance imaging (fMRI', 'Receiving active versus sham rTMS', 'active rTMS with emotion regulation training']","['fMRI', 'emotion regulation']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",37.0,0.249586,"Receiving active versus sham rTMS led to significantly higher high frequency heart rate variability during regulation, lower regulation duration during the intervention, and higher likelihood to use CR during the week following the intervention.","[{'ForeName': 'Andrada D', 'Initials': 'AD', 'LastName': 'Neacsiu', 'Affiliation': 'Duke University Health System, Durham, North Carolina, 27710, United States. Electronic address: andrada.neacsiu@duke.edu.'}, {'ForeName': 'Lysianne', 'Initials': 'L', 'LastName': 'Beynel', 'Affiliation': 'Duke University Health System, Durham, North Carolina, 27710, United States.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Graner', 'Affiliation': 'Duke University, Durham, North Carolina 27710, United States.'}, {'ForeName': 'Steven T', 'Initials': 'ST', 'LastName': 'Szabo', 'Affiliation': 'Duke University Health System, Durham, North Carolina, 27710, United States; Durham VAMC, Durham, North Carolina, United States.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Appelbaum', 'Affiliation': 'Duke University Health System, Durham, North Carolina, 27710, United States.'}, {'ForeName': 'Moria J', 'Initials': 'MJ', 'LastName': 'Smoski', 'Affiliation': 'Duke University Health System, Durham, North Carolina, 27710, United States; Duke University, Durham, North Carolina 27710, United States.'}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'LaBar', 'Affiliation': 'Duke University, Durham, North Carolina 27710, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2022.01.053']
1806,35086060,"Randomized, sham-controlled trial of transcranial magnetic stimulation augmentation of cognitive remediation in schizophrenia.",,2022,,['schizophrenia'],['transcranial magnetic stimulation augmentation'],[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]",[],,0.196939,,"[{'ForeName': 'Jagadisha', 'Initials': 'J', 'LastName': 'Thirthalli', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bengaluru, India. Electronic address: jagatth@yahoo.com.'}, {'ForeName': 'Urvakhsh Meherwan', 'Initials': 'UM', 'LastName': 'Mehta', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bengaluru, India.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Keshav Kumar', 'Affiliation': 'Department of Clinical Psychology, National Institute of Mental Health & Neurosciences (NIMHANS), Bengaluru, India.'}, {'ForeName': 'Vidhi', 'Initials': 'V', 'LastName': 'Tyagi', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bengaluru, India.'}, {'ForeName': 'Poornima', 'Initials': 'P', 'LastName': 'Sunder', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bengaluru, India.'}, {'ForeName': 'Arpitha', 'Initials': 'A', 'LastName': 'Dharmappa', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bengaluru, India.'}, {'ForeName': 'Ramajayam', 'Initials': 'R', 'LastName': 'Govindaraj', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bengaluru, India.'}, {'ForeName': 'Jitender', 'Initials': 'J', 'LastName': 'Saini', 'Affiliation': 'Department of Neuroradiology and Interventional Radiology, National Institute of Mental Health & Neurosciences (NIMHANS), Bengaluru, India.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Chaturvedi', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bengaluru, India.'}, {'ForeName': 'B N', 'Initials': 'BN', 'LastName': 'Gangadhar', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bengaluru, India.'}]",Schizophrenia research,['10.1016/j.schres.2022.01.028']
1807,35096134,Ultrasound Image-Guided Nerve Block Combined with General Anesthesia under an Artificial Intelligence Algorithm on Patients Undergoing Radical Gastrectomy for Gastric Cancer during and after Operation.,"This study was aimed at investigating the location of gastric cancer by using a gastroscope image based on an artificial intelligence algorithm for gastric cancer and the effect of ultrasonic-guided nerve block combined with general anesthesia on patients undergoing gastric cancer surgery. A total of 160 patients who were undergoing gastric cancer surgery from March 2019 to March 2021 were collected as the research objects, and the convolutional neural network (CNN) algorithm was used to segment the gastroscope image of gastric cancer. The patients were randomly divided into a simple general anesthesia group of 80 cases and a transversus abdominis plane block combined with rectus abdominis sheath block combined with the general anesthesia group of 80 cases. Then, compare the systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) at the four time points T 0 , T 1 , T 2 , and T 3 . The times of analgesic drug use within 48 hours after operation and postoperative adverse reactions were recorded. The visual analog scale (VAS) scores were also recorded at 4 h, 12 h, 24 h, and 48 h. The results show that the image quality after segmentation is good: the accuracy of tumor location is 75.67%, which is similar to that of professional endoscopists. Compared with the general anesthesia group, the transversus abdominis plane block combined with the rectus sheath block combined with the general anesthesia group had fewer anesthetics, and the difference was statistically significant ( P  < 0.05). Compared with the general anesthesia group, SBP, DBP, and HR were significantly reduced at T 1 , T 2 , and T 3  in the transverse abdominis plane block combined with rectus sheath block and general anesthesia group ( P  < 0.05). Compared with the simple general anesthesia group, the VAS scores of the transversus abdominis plane block combined with rectus sheath block combined with the general anesthesia group decreased at 4 h, 12 h, and 24 h after surgery, and the difference was statistically significant ( P  < 0.05). The number of analgesics used in transversus abdominis plane block combined with the rectus sheath block combined with the general anesthesia group within 48 hours after operation was significantly less than that in the general anesthesia group, and the difference was statistically significant ( P  < 0.05). The average incidence of adverse reactions in the nerve block combined with the general anesthesia group was 2.5%, which was lower than the average incidence of 3.75% in the general anesthesia group. In summary, the CNN algorithm can accurately segment the lesions in the ultrasonic images of gastric cancer, which was convenient for doctors to make a more accurate judgment on the lesions, and provided a basis for the preoperative examination of radical gastrectomy for gastric cancer. Ultrasonic-guided nerve block combined with general anesthesia can effectively improve the analgesic effect of radical gastrectomy for gastric cancer, reduced intraoperative and postoperative adverse reactions and analgesic drug dosage, and had a good effect on postoperative recovery of patients. The combined application of these two methods can further improve the precision treatment of gastric cancer patients and accelerate postoperative recovery.",2022,"Ultrasonic-guided nerve block combined with general anesthesia can effectively improve the analgesic effect of radical gastrectomy for gastric cancer, reduced intraoperative and postoperative adverse reactions and analgesic drug dosage, and had a good effect on postoperative recovery of patients.","['gastric cancer patients', '160 patients who were undergoing gastric cancer surgery from March 2019 to March 2021 were collected as the research objects, and the', 'patients undergoing gastric cancer surgery', 'Patients Undergoing Radical Gastrectomy for Gastric Cancer during and after Operation']","['artificial intelligence algorithm', 'Ultrasound Image-Guided Nerve Block Combined with General Anesthesia under an Artificial Intelligence Algorithm', 'Ultrasonic-guided nerve block combined with general anesthesia', 'convolutional neural network (CNN) algorithm', 'ultrasonic-guided nerve block combined with general anesthesia', 'simple general anesthesia group of 80 cases and a transversus abdominis plane block combined with rectus abdominis sheath block combined with the general anesthesia group of 80 cases']","['SBP, DBP, and HR', 'number of analgesics used in transversus abdominis plane block', 'postoperative adverse reactions', 'VAS scores of the transversus abdominis plane block combined with rectus sheath block', 'visual analog scale (VAS) scores', 'average incidence of adverse reactions', 'systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR']","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0565313', 'cui_str': 'Radical gastrectomy'}]","[{'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",160.0,0.0620967,"Ultrasonic-guided nerve block combined with general anesthesia can effectively improve the analgesic effect of radical gastrectomy for gastric cancer, reduced intraoperative and postoperative adverse reactions and analgesic drug dosage, and had a good effect on postoperative recovery of patients.","[{'ForeName': 'Wanqiu', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000 Sichuan, China.'}, {'ForeName': 'Liuyingzi', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000 Sichuan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, People's Hospital of Yilong County, Nanchong, 636000 Sichuan, China.""}, {'ForeName': 'Biqian', 'Initials': 'B', 'LastName': 'Dong', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000 Sichuan, China.'}]",Computational and mathematical methods in medicine,['10.1155/2022/6914157']
1808,35103604,An Innovative Telemedical Network to Improve Infectious Disease Management in Critically Ill Patients and Outpatients (TELnet@NRW): Stepped-Wedge Cluster Randomized Controlled Trial.,"BACKGROUND


Evidence-based infectious disease and intensive care management is more relevant than ever. Medical expertise in the two disciplines is often geographically limited to university institutions. In addition, the interconnection between inpatient and outpatient care is often insufficient (eg, no shared electronic health record and no digital transfer of patient findings).
OBJECTIVE


This study aims to establish and evaluate a telemedical inpatient-outpatient network based on expert teleconsultations to increase treatment quality in intensive care medicine and infectious diseases.
METHODS


We performed a multicenter, stepped-wedge cluster randomized trial (February 2017 to January 2020) to establish a telemedicine inpatient-outpatient network among university hospitals, hospitals, and outpatient physicians in North Rhine-Westphalia, Germany. Patients aged ≥18 years in the intensive care unit or consulting with a physician in the outpatient setting were eligible. We provided expert knowledge from intensivists and infectious disease specialists through advanced training courses and expert teleconsultations with 24/7/365 availability on demand respectively once per week to enhance treatment quality. The primary outcome was adherence to the 10 Choosing Wisely recommendations for infectious disease management. Guideline adherence was analyzed using binary logistic regression models.
RESULTS


Overall, 159,424 patients (10,585 inpatients and 148,839 outpatients) from 17 hospitals and 103 outpatient physicians were included. There was a significant increase in guideline adherence in the management of Staphylococcus aureus infections (odds ratio [OR] 4.00, 95% CI 1.83-9.20; P<.001) and in sepsis management in critically ill patients (OR 6.82, 95% CI 1.27-56.61; P=.04). There was a statistically nonsignificant decrease in sepsis-related mortality from 29% (19/66) in the control group to 23.8% (50/210) in the intervention group. Furthermore, the extension of treatment with prophylactic antibiotics after surgery was significantly less likely (OR 9.37, 95% CI 1.52-111.47; P=.04). Patients treated by outpatient physicians, who were regularly participating in expert teleconsultations, were also more likely to be treated according to guideline recommendations regarding antibiotic therapy for uncomplicated upper respiratory tract infections (OR 1.34, 95% CI 1.16-1.56; P<.001) and asymptomatic bacteriuria (OR 9.31, 95% CI 3.79-25.94; P<.001). For the other recommendations, we found no significant effects, or we had too few observations to generate models. The key limitations of our study include selection effects due to the applied on-site triage of patients as well as the limited possibilities to control for secular effects.
CONCLUSIONS


Telemedicine facilitates a direct round-the-clock interaction over broad distances between intensivists or infectious disease experts and physicians who care for patients in hospitals without ready access to these experts. Expert teleconsultations increase guideline adherence and treatment quality in infectious disease and intensive care management, creating added value for critically ill patients.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03137589; https://clinicaltrials.gov/ct2/show/NCT03137589.",2022,"Expert teleconsultations increase guideline adherence and treatment quality in infectious disease and intensive care management creating added value for critically ill patients.
","['critically ill patients and outpatients', 'among university hospitals, hospitals, and outpatient physicians in North Rhine Westphalia, Germany', '159,424 patients (10,585 inpatients, 148,839 outpatients) from 17 hospitals and 103 outpatient physicians were included', 'critically ill patients', 'Patients ≥ 18 years of age in the intensive care unit (ICU) or consulting with a physician in the outpatient setting were eligible']",['telemedicine inpatient-outpatient network'],"['Guideline adherence', 'guideline adherence', 'sepsis management', 'adherence to the ten Choosing Wisely® recommendations for infectious disease management', 'asymptomatic bacteriuria', 'Staphylococcus aureus infections', 'sepsis related mortality']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0525059', 'cui_str': 'Guideline Adherence'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0262380', 'cui_str': 'Asymptomatic bacteriuria'}, {'cui': 'C1318973', 'cui_str': 'Infection due to Staphylococcus aureus'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",148839.0,0.0468619,"Expert teleconsultations increase guideline adherence and treatment quality in infectious disease and intensive care management creating added value for critically ill patients.
","[{'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Marx', 'Affiliation': 'Department of Intensive Care Medicine and Intermediate Care, Medical Faculty RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Greiner', 'Affiliation': 'School of Public Health, Department of Health Economics and Health Care Management, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Juhra', 'Affiliation': 'University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Svenja', 'Initials': 'S', 'LastName': 'Elkenkamp', 'Affiliation': 'School of Public Health, Department of Health Economics and Health Care Management, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gensorowsky', 'Affiliation': 'School of Public Health, Department of Health Economics and Health Care Management, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Lemmen', 'Affiliation': 'Division of Infection Control and Infectious Diseases, Medical Faculty RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Englbrecht', 'Affiliation': 'University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Dohmen', 'Affiliation': 'Department of Intensive Care Medicine and Intermediate Care, Medical Faculty RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Gottschalk', 'Affiliation': 'University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Haverkamp', 'Affiliation': 'Division of Infection Control and Infectious Diseases, Medical Faculty RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Hempen', 'Affiliation': 'Physician Network, Medizin und Mehr eG (MuM), Buende, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Flügel-Bleienheuft', 'Affiliation': 'Physician Network, Gesundheitsnetz Köln-Süd (GKS) e.V., Cologne, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bause', 'Affiliation': 'University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Henna', 'Initials': 'H', 'LastName': 'Schulze-Steinen', 'Affiliation': 'Department of Intensive Care Medicine and Intermediate Care, Medical Faculty RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Rademacher', 'Affiliation': 'Department of Intensive Care Medicine and Intermediate Care, Medical Faculty RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kistermann', 'Affiliation': 'Department of Intensive Care Medicine and Intermediate Care, Medical Faculty RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hoch', 'Affiliation': 'Physician Network, Gesundheitsnetz Köln-Süd (GKS) e.V., Cologne, Germany.'}, {'ForeName': 'Hans-Juergen', 'Initials': 'HJ', 'LastName': 'Beckmann', 'Affiliation': 'Physician Network, Medizin und Mehr eG (MuM), Buende, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lanckohr', 'Affiliation': 'University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Lowitsch', 'Affiliation': 'Healthcare IT Solutions GmbH, Aachen, Germany.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Peine', 'Affiliation': 'Department of Intensive Care Medicine and Intermediate Care, Medical Faculty RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Juzek-Kuepper', 'Affiliation': 'Division of Infection Control and Infectious Diseases, Medical Faculty RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Benstoem', 'Affiliation': 'Department of Intensive Care Medicine and Intermediate Care, Medical Faculty RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Sperling', 'Affiliation': 'University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Deisz', 'Affiliation': 'Department of Intensive Care Medicine and Intermediate Care, Medical Faculty RWTH Aachen, Aachen, Germany.'}]",Journal of medical Internet research,['10.2196/34098']
1809,35085999,Effects of previous experience with dry needling therapy on blinding effectiveness and pain outcomes in people with neck pain: A preliminary sham-controlled study.,"BACKGROUND


Participants' previous experience with an intervention may be an important variable when conducting sham-controlled trials.
OBJECTIVE


This study explored if previous experience with dry needling (DN) influenced blinding effectiveness and pain outcomes, after the application of DN in patients with neck pain.
DESIGN


A preliminary randomized, sham-controlled study.
METHODS


Participants were randomized to receive a single session of real or sham DN. Previous experience with DN (yes/no) was recorded. Blinding effectiveness was assessed by asking participants to guess their group allocation (real/sham/not sure) 5 min post-intervention. Outcomes including pain intensity, pressure pain thresholds, and self-perceived improvement, were assessed by a blinded assessor at baseline, one- and seven-days post-intervention.
RESULTS


Of 50 patients recruited, 30 had previous experience and 20 did not. Fifty-seven percent (n = 17/30) with previous experience and 35% (n = 7/20) without experience correctly identified their group allocation, but this difference was not significant (χ 2  = 2.333; P = 0.127). No interaction between previous experience and clinical outcomes were found, except that participants with previous experience receiving real DN showed greater improvements in pain during cervical rotation than those without previous experience at one (Δ -11.5 mm 95%CI -22.0 to -1.0 mm) and seven days (Δ -8.5 mm, -16.00 to -1.0 mm) post-intervention.
CONCLUSIONS


Participants with previous experience were 22% more accurate at identifying their group allocation than those without experience, but the difference was not significant. Previous experience did not influence most clinical outcomes, except for pain intensity after real DN. Future studies evaluating effects of previous experience of DN should include more detailed information of previous experience.",2022,"No interaction between previous experience and clinical outcomes were found, except that participants with previous experience receiving real DN showed greater improvements in pain during cervical rotation than those without previous experience at one (Δ -11.5 mm 95%CI -22.0 to -1.0 mm) and seven days (Δ -8.5 mm, -16.00 to -1.0 mm) post-intervention.
","['patients with neck pain', 'Participants', 'people with neck pain', 'Fifty-seven percent (n\xa0', '50 patients recruited, 30 had previous experience and 20 did not']","['single session of real or sham DN', 'dry needling (DN', 'dry needling therapy']","['pain intensity, pressure pain thresholds, and self-perceived improvement', 'pain during cervical rotation', 'blinding effectiveness and pain outcomes', 'pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",50.0,0.245461,"No interaction between previous experience and clinical outcomes were found, except that participants with previous experience receiving real DN showed greater improvements in pain during cervical rotation than those without previous experience at one (Δ -11.5 mm 95%CI -22.0 to -1.0 mm) and seven days (Δ -8.5 mm, -16.00 to -1.0 mm) post-intervention.
","[{'ForeName': 'Gracia M', 'Initials': 'GM', 'LastName': 'Gallego-Sendarrubias', 'Affiliation': 'Department of Physical Therapy, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Lennard', 'Initials': 'L', 'LastName': 'Voogt', 'Affiliation': 'Rotterdam University of Applied Sciences, Department of Physiotherapy, Rotterdam, the Netherlands.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Arias-Buría', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain; Cátedra Institucional en Docencia, Clínica e Investigación en Fisioterapia: Terapia Manual, Punción Seca y Ejercicio Terapéutico, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain. Electronic address: joseluis.arias@urjc.es.'}, {'ForeName': 'Felicity A', 'Initials': 'FA', 'LastName': 'Braithwaite', 'Affiliation': 'IIMPACT in Health, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain; Cátedra Institucional en Docencia, Clínica e Investigación en Fisioterapia: Terapia Manual, Punción Seca y Ejercicio Terapéutico, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2022.102515']
1810,34920291,"Maintenance therapy of patients with recurrent epithelial ovarian carcinoma with the anti-tumor-associated-mucin-1 antibody gatipotuzumab: results from a double-blind, placebo-controlled, randomized, phase II study.","BACKGROUND


Gatipotuzumab is a humanized monoclonal antibody recognizing the carbohydrate-induced epitope of the tumor-associated mucin-1 (TA-MUC1). This study aimed to evaluate the efficacy and safety of switch maintenance therapy with gatipotuzumab in patients with TA-MUC1-positive recurrent ovarian, fallopian tube, or primary high-grade serous peritoneal cancer.
PATIENTS AND METHODS


In this double-blind, randomized, placebo-controlled, phase II trial, patients with at least stable disease (SD) following chemotherapy were randomized 2:1 to receive intravenous gatipotuzumab (500 mg followed by 1700 mg 1 week later) or placebo every 3 weeks until tumor progression or unacceptable toxicity occurred. Stratification factors were the number of prior chemotherapy lines (2 versus 3-5), response versus SD after the most recent chemotherapy, and progression-free survival (PFS) <6 versus 6-12 months following the prior therapy. Primary endpoint was PFS according to modified immune-related RECIST 1.1 response criteria. Secondary endpoints were PFS at 6 months, safety, overall response rate, CA-125 progression, overall survival, quality of life, and pharmacokinetics.
RESULTS


Overall, 216 patients were randomized to gatipotuzumab (n  =  151) or placebo (n  =  65). Median PFS with gatipotuzumab was 3.5 months as compared with 3.5 months with placebo (hazard ratio 0.96, 95% confidence interval 0.69-1.33, P  =  0.80). No advantage for gatipotuzumab over placebo was seen in the secondary efficacy endpoints or in any stratified subgroups. Gatipotuzumab was well tolerated, with mild to moderate infusion-related reactions being the most common adverse events.
CONCLUSIONS


Gatipotuzumab switch maintenance therapy does not improve outcome in TA-MUC1-positive ovarian cancer patients.
TRIAL REGISTRATION


ClinicalTrials.govNCT01899599; https://clinicaltrials.gov/ct2/show/NCT01899599.",2022,"Median PFS with gatipotuzumab was 3.5 months as compared with 3.5 months with placebo (hazard ratio 0.96, 95% confidence interval 0.69-1.33, P  =  0.80).","['216 patients were randomized to', 'TA-MUC1-positive ovarian cancer patients', 'patients with recurrent epithelial ovarian carcinoma with the anti-tumor-associated-mucin-1 antibody gatipotuzumab', 'patients with at least stable disease (SD) following chemotherapy', 'patients with TA-MUC1-positive recurrent ovarian, fallopian tube, or primary high-grade serous peritoneal cancer']","['placebo', 'gatipotuzumab', 'Maintenance therapy', 'intravenous gatipotuzumab', 'Gatipotuzumab switch maintenance therapy', 'Gatipotuzumab']","['PFS according to modified immune-related RECIST 1.1 response criteria', 'progression-free survival (PFS', 'efficacy and safety', 'PFS at 6 months, safety, overall response rate, CA-125 progression, overall survival, quality of life, and pharmacokinetics', 'Median PFS']","[{'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1612111', 'cui_str': 'MUC1 protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C2986405', 'cui_str': 'PankoMab-GEX'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015560', 'cui_str': 'Fallopian tube structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2986405', 'cui_str': 'PankoMab-GEX'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",216.0,0.621413,"Median PFS with gatipotuzumab was 3.5 months as compared with 3.5 months with placebo (hazard ratio 0.96, 95% confidence interval 0.69-1.33, P  =  0.80).","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'Department of Oncology, UCL Cancer Institute, University College London, London, UK. Electronic address: j.ledermann@ucl.ac.uk.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zurawski', 'Affiliation': 'Department of Oncology, Franciszek Lukaszczyk Oncology Center, Bydgoszcz, Poland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Raspagliesi', 'Affiliation': 'Department of Gynecologic Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Department of Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST IRCCS, Meldola, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Arranz Arija', 'Affiliation': 'Department of Medical Oncology, Hospital General Universitario Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Romeo Marin', 'Affiliation': 'Department of Medical Oncology, B-ARGO group, Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lisyanskaya', 'Affiliation': 'Department of Oncogynecology, St.-Petersburg Oncological City Hospital, St. Petersburg, Russia.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Póka', 'Affiliation': 'Department of Gynecologic Oncology, Debrecen University Clinical Center, Debrecen, Hungary.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Markowska', 'Affiliation': 'Klinika Onkologii, Oddzial Ginekologii Onkologicznej, Poznan, Poland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cebotaru', 'Affiliation': 'Radioterapie, Institutul Oncologic ""Prof. Dr. Ioan Chiricuta"", Cluj-Napoca, Romania.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Casado Herraez', 'Affiliation': 'Department of Medical Oncology, Hospital Clínico Universitario San Carlos, Madrid, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Department of Medical Gynecologic Oncology, European Institute of Oncology IRCCS, and University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kutarska', 'Affiliation': 'Iii Oddzial Ginekologii Onkologicznej, Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Mount Vernon Cancer Centre, Middlesex, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jacobs', 'Affiliation': 'Premier Research, Reading, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ahrens-Fath', 'Affiliation': 'Glycotope GmbH, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Glycotope GmbH, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zurlo', 'Affiliation': 'Glycotope GmbH, Berlin, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Charité Campus Virchow-Klinikum, Berlin, Germany.'}]",ESMO open,['10.1016/j.esmoop.2021.100311']
1811,35033949,Effects of exercise in non-treatment seeking adults with alcohol use disorder: A three-armed randomized controlled trial (FitForChange).,"BACKGROUND


Most individuals with alcohol use disorder (AUD) do not seek treatment. Stigma and the desire to self-manage the problem are likely explanations. Exercise is an emerging treatment option but studies in non-treatment seeking individuals are lacking. We compared the effects of aerobic exercise, yoga, and treatment as usual (phone-based support) on alcohol consumption in non-treatment seeking adults with AUD.
METHODS


Three-group parallel, single blind, randomized controlled trial. 140 physically inactive adults aged 18-75 diagnosed with AUD were included in this community-based trial. Participants were randomized to either aerobic exercise (n = 49), yoga (n = 46) or treatment as usual (n = 45) for 12-weeks. The primary study outcome was weekly alcohol consumption at week 13 (Timeline Follow-back).
RESULTS


A significant decrease in weekly alcohol consumption was seen in all three groups: aerobic exercise (mean ∆ = - 5.0, 95% C = - 10.3, - 3.5), yoga group (mean ∆ = - 6.9, 95% CI = - 10.3, - 3.5) and TAU (mean ∆ = - 6.6, 95% CI = - 8.8, - 4.4). The between group changes were not statistically significant at follow-up. Per-protocol analyzes showed that the mean number of drinks per week reduced more in both TAU (mean ∆ = - 7.1, 95% CI = - 10.6, - 3.7) and yoga (mean ∆ = - 8.7, 95% CI = - 13.2, - 4.1) compared to aerobic exercise (mean ∆ = - 1.7, 95% CI = - 4.4, 1. 0), [F(2, 55) = 4.9, p = 0.011].
CONCLUSIONS


Participation in a 12-week stand-alone exercise program was associated with clinically meaningful reductions in alcohol consumption comparable to usual care (phone counseling) by an alcohol treatment specialist.",2022,"A significant decrease in weekly alcohol consumption was seen in all three groups: aerobic exercise (mean ∆ = - 5.0, 95% C = - 10.3, - 3.5), yoga group (mean ∆ = - ","['140 physically inactive adults aged 18-75 diagnosed with AUD', 'non-treatment seeking adults with alcohol use disorder', 'individuals with alcohol use disorder (AUD', 'non-treatment seeking adults with AUD']","['aerobic exercise, yoga, and treatment as usual (phone-based support', 'exercise', 'aerobic exercise']","['weekly alcohol consumption at week 13 (Timeline Follow-back', 'alcohol consumption', 'aerobic exercise', 'weekly alcohol consumption', 'mean number of drinks']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]",140.0,0.120098,"A significant decrease in weekly alcohol consumption was seen in all three groups: aerobic exercise (mean ∆ = - 5.0, 95% C = - 10.3, - 3.5), yoga group (mean ∆ = - ","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gunillasdotter', 'Affiliation': 'Epidemiology of Psychiatric Conditions, Substance use and Social Environment (EPiCSS), Department of Public Health Sciences, Karolinska Institutet, 171 77 Stockholm, Sweden; Centre for Psychiatry Research, Sweden, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Services, 114 35 Stockholm, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Andréasson', 'Affiliation': 'Epidemiology of Psychiatric Conditions, Substance use and Social Environment (EPiCSS), Department of Public Health Sciences, Karolinska Institutet, 171 77 Stockholm, Sweden; Centre for Psychiatry Research, Sweden, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Services, 114 35 Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jirwe', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, 141 83 Huddinge, Sweden; Department of Health Sciences, the Swedish Red Cross University College, 14121 Huddinge, Sweden.'}, {'ForeName': 'Örjan', 'Initials': 'Ö', 'LastName': 'Ekblom', 'Affiliation': 'Swedish School of Sport and Health Science (GIH), Lidingövägen 1, 114 33 Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hallgren', 'Affiliation': 'Epidemiology of Psychiatric Conditions, Substance use and Social Environment (EPiCSS), Department of Public Health Sciences, Karolinska Institutet, 171 77 Stockholm, Sweden. Electronic address: mats.hallgren@ki.se.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2022.109266']
1812,35074539,Effect of a preoperative mobilization program on perioperative complications and function recovery in older adults with femoral neck fracture.,"OBJECTIVE


To assess the effectiveness of a preoperative mobilization program for preventing perioperative complications and improving function in older adults with femoral neck fracture who delayed surgery.
METHODS


In this controlled, quasi-experimental study, a total of 150 older patients with femoral neck fracture who waited more than 2 days before surgery were assigned to the Intervention group or control group. Perioperative complications were recorded. The change of physical function was assessed using the modified Barthel index (MBI).
RESULTS


The overall perioperative complication rate (52.2% vs. 73.5%), pulmonary infection (6.0% vs. 16.9%), delirium (9.0% vs. 24.1%) in the intervention group were lower than those in the control group. The intervention group had significantly better improvement in MBI score preoperatively and postoperatively.
CONCLUSION


A preoperative mobilization program was shown to have advantages in preventing perioperative complications and promoting early functional recovery in older adults with delayed surgery of femoral neck fracture.",2022,A preoperative mobilization program was shown to have advantages in preventing perioperative complications and promoting early functional recovery in older adults with delayed surgery of femoral neck fracture.,"['150 older patients with femoral neck fracture who waited more than 2 days before surgery', 'older adults with delayed surgery of femoral neck fracture', 'older adults with femoral neck fracture', 'older adults with femoral neck fracture who delayed surgery']","['Intervention group or control group', 'preoperative mobilization program']","['pulmonary infection', 'overall perioperative complication rate', 'delirium', 'Perioperative complications', 'change of physical function', 'MBI score', 'perioperative complications and function recovery']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}]",150.0,0.0282187,A preoperative mobilization program was shown to have advantages in preventing perioperative complications and promoting early functional recovery in older adults with delayed surgery of femoral neck fracture.,"[{'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, Orthopedic Research Institute, West China Hospital, Sichuan University, Chengdu, Sichuan Province, 610041, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Long', 'Affiliation': 'Department of Orthopedics, Orthopedic Research Institute, West China Hospital, Sichuan University, Chengdu, Sichuan Province, 610041, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Orthopedic Research Institute, West China Hospital, Sichuan University, Chengdu, Sichuan Province, 610041, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopedics, Orthopedic Research Institute, West China Hospital, Sichuan University, Chengdu, Sichuan Province, 610041, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Duan', 'Affiliation': ""Department of Orthopedics, Orthopedic Research Institute, West China Hospital, Sichuan University, Chengdu, Sichuan Province, 610041, China; Ganzi Tibetan Autonomous Prefecture People's Hospital, Kangding, Sichuan Province, 626000, China. Electronic address: dxbaal@hotmail.com.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Xiang', 'Affiliation': 'Department of Orthopedics, Orthopedic Research Institute, West China Hospital, Sichuan University, Chengdu, Sichuan Province, 610041, China.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2022.01.003']
1813,35092845,Effects of curtailed sleep on cardiac stress biomarkers following high-intensity exercise.,"OBJECTIVE


Physical exercise-especially at high intensity-is known to impose cardiac stress, as mirrored by, e.g., increased blood levels of cardiac stress biomarkers such as cardiac Troponin T (cTnT) and NT-proBNP. We examined healthy young participants to determine whether a few nights of short sleep duration alter the effects of acute exercise on these blood biomarkers.
METHODS


Sixteen men participated in a randomized order in a crossover design, comprising three consecutive nights of a) normal sleep duration (NS, 8.5 h of sleep/night) and b) sleep restriction (SR, 4.25 h of sleep/night). Blood was repeatedly sampled for determination of NT-proBNP and cTnT serum levels before and after a high-intensity exercise protocol (i.e., 75% VO 2 maxReserve  cycling on an ergometer).
RESULTS


Under pre-exercise sedentary conditions, blood levels of cTnT and NT-proBNP did not significantly differ between the sleep conditions (P > 0.10). However, in response to exercise, the surge of circulating cTnT was significantly greater following SR than NS (+37-38% at 120-240 min post-exercise, P ≤ 0.05). While blood levels of NT-proBNP rose significantly in response to exercise, they did not differ between the sleep conditions.
CONCLUSION


Recurrent sleep restriction may increase the cardiac stress response to acute high-intensity exercise in healthy young individuals. However, our findings must be further confirmed in women, older subjects and in patients with a history of heart disease.",2022,"While blood levels of NT-proBNP rose significantly in response to exercise, they did not differ between the sleep conditions.
","['healthy young participants', 'healthy young individuals', 'example older subjects or in patients with a history of heart disease', 'Sixteen men participated']","['normal sleep duration (NS, 8.5 hours of sleep/night) and b) sleep restriction (SR, 4.25 hours of sleep/night', 'curtailed sleep']","['cardiac stress biomarkers', 'cardiac stress response', 'surge of circulating cTnT', 'blood levels of NT-proBNP', 'blood levels of cTnT and NT-proBNP']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C3538889', 'cui_str': 'Cardiac troponin T'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]",16.0,0.00741582,"While blood levels of NT-proBNP rose significantly in response to exercise, they did not differ between the sleep conditions.
","[{'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Martikainen', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Sweden; Department of Medical Cell Biology, Uppsala University, Sweden.'}, {'ForeName': 'Fjola', 'Initials': 'F', 'LastName': 'Sigurdardottir', 'Affiliation': 'Department of Cardiology, Akershus University Hospital, Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Benedict', 'Affiliation': 'Department of Surgical Sciences (Sleep Science Laboratory, BMC), Uppsala University, Sweden.'}, {'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Omland', 'Affiliation': 'Department of Cardiology, Akershus University Hospital, Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cedernaes', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Sweden; Department of Medical Cell Biology, Uppsala University, Sweden. Electronic address: jonathan.cedernaes@medsci.uu.se.'}]",Molecular metabolism,['10.1016/j.molmet.2022.101445']
1814,35100192,Lung- and Diaphragm-Protective Ventilation by Titrating Inspiratory Support to Diaphragm Effort: A Randomized Clinical Trial.,"OBJECTIVES


Lung- and diaphragm-protective ventilation is a novel concept that aims to limit the detrimental effects of mechanical ventilation on the diaphragm while remaining within limits of lung-protective ventilation. The premise is that low breathing effort under mechanical ventilation causes diaphragm atrophy, whereas excessive breathing effort induces diaphragm and lung injury. In a proof-of-concept study, we aimed to assess whether titration of inspiratory support based on diaphragm effort increases the time that patients have effort in a predefined ""diaphragm-protective"" range, without compromising lung-protective ventilation.
DESIGN


Randomized clinical trial.
SETTING


Mixed medical-surgical ICU in a tertiary academic hospital in the Netherlands.
PATIENTS


Patients (n = 40) with respiratory failure ventilated in a partially-supported mode.
INTERVENTIONS


In the intervention group, inspiratory support was titrated hourly to obtain transdiaphragmatic pressure swings in the predefined ""diaphragm-protective"" range (3-12 cm H2O). The control group received standard-of-care.
MEASUREMENTS AND MAIN RESULTS


Transdiaphragmatic pressure, transpulmonary pressure, and tidal volume were monitored continuously for 24 hours in both groups. In the intervention group, more breaths were within ""diaphragm-protective"" range compared with the control group (median 81%; interquartile range [64-86%] vs 35% [16-60%], respectively; p < 0.001). Dynamic transpulmonary pressures (20.5 ± 7.1 vs 18.5 ± 7.0 cm H2O; p = 0.321) and tidal volumes (7.56 ± 1.47 vs 7.54 ± 1.22 mL/kg; p = 0.961) were not different in the intervention and control group, respectively.
CONCLUSIONS


Titration of inspiratory support based on patient breathing effort greatly increased the time that patients had diaphragm effort in the predefined ""diaphragm-protective"" range without compromising tidal volumes and transpulmonary pressures. This study provides a strong rationale for further studies powered on patient-centered outcomes.",2022,"In the intervention group, more breaths were within ""diaphragm-protective"" range compared with the control group (median 81%; interquartile range [64-86%] vs 35% [16-60%], respectively; p < 0.001).","['Patients (n = 40) with respiratory failure ventilated in a partially-supported mode', 'Mixed medical-surgical ICU in a tertiary academic hospital in the Netherlands']","['Lung- and diaphragm-protective', 'standard-of-care', 'Lung- and Diaphragm-Protective Ventilation']","['tidal volumes', 'Dynamic transpulmonary pressures', 'Transdiaphragmatic pressure, transpulmonary pressure, and tidal volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205504', 'cui_str': 'Transdiaphragmatic approach'}]",40.0,0.0754064,"In the intervention group, more breaths were within ""diaphragm-protective"" range compared with the control group (median 81%; interquartile range [64-86%] vs 35% [16-60%], respectively; p < 0.001).","[{'ForeName': 'Heder J', 'Initials': 'HJ', 'LastName': 'de Vries', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam UMC location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Annemijn H', 'Initials': 'AH', 'LastName': 'Jonkman', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam UMC location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Harm J', 'Initials': 'HJ', 'LastName': 'de Grooth', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam UMC location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan Willem', 'Initials': 'JW', 'LastName': 'Duitman', 'Affiliation': 'Center for Experimental and Molecular Medicine, Amsterdam UMC, location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Armand R J', 'Initials': 'ARJ', 'LastName': 'Girbes', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam UMC location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Coen A C', 'Initials': 'CAC', 'LastName': 'Ottenheijm', 'Affiliation': 'Amsterdam Cardiovascular Sciences Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Schultz', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam UMC location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Data Science, Amsterdam UMC, Location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Yingrui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam UMC location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Angelique M E', 'Initials': 'AME', 'LastName': 'de Man', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam UMC location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Pieter R', 'Initials': 'PR', 'LastName': 'Tuinman', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam UMC location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Leo M A', 'Initials': 'LMA', 'LastName': 'Heunks', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam UMC location VUmc, Amsterdam, the Netherlands.'}]",Critical care medicine,['10.1097/CCM.0000000000005395']
1815,35100456,"Instrumentation kinematics does not affect bacterial reduction, post-operative pain, and flare-ups: A randomized clinical trial.","AIM


This randomized clinical trial aimed to assess the effect of instrumentation kinematics (reciprocation or continuous rotation) on bacterial reduction, post-operative pain, and incidence of flare-ups after root canal treatment of single-rooted mandibular premolars with asymptomatic apical periodontitis.
METHODOLOGY


Sixty-six patients were included in this prospective, parallel, randomized clinical trial. Patients were randomly allocated into two groups (N = 33) according to the kinematics of the shaping instrument: WaveOne Gold (WO) used in reciprocation or One Shape (OS) used in continuous rotation. Under complete asepsis, bacterial samples were taken before (S1) and after (S2) a standard cleaning and shaping protocol. Evaluation of bacterial reduction was done by both culture technique and quantitative real-time polymerase chain reaction (qPCR) analysis. Post-operative pain was evaluated using the visual analogue scale (VAS) after 24, 48, and 72 h following treatment, while flare-ups were recorded as a binary outcome (Yes/No). Independent and paired t-tests were used for inter- and intra-group comparisons for bacterial count data, respectively. For post-operative pain score, inter-group comparisons were analyzed using the Mann-Whitney U-test while intra-group comparisons were analyzed using Friedman test followed by pairwise comparisons utilizing the Wilcoxon signed rank test with Bonferroni correction. The significance level was set at p ≤ .05 within all tests.
RESULTS


All the allocated participants received the intervention and were analysed. The comparison between culture and qPCR methods showed that qPCR analysis demonstrated significantly higher pre-instrumentation baseline bacterial count (p < .05). The percentage of bacterial reduction, detected by either method, significantly decreased after instrumentation using either rotation or reciprocation kinematics (p < .05). However, the difference between the WOG or OS files was statistically non-significant (p > .05). The intra-group comparisons showed a significant reduction in post-operative pain with time (p < .05) for both groups. However, the inter-group comparison demonstrated that the difference in post-operative pain after the use of either WOG or OS was statistically non-significant (p > .05). The incidence of flare-ups between both groups was also not-significant (p = 1).
CONCLUSIONS


Shaping kinematics, either rotation or reciprocation motions, had no impact on bacterial reduction and the incidence of post-operative pain and flare-ups after root canal preparation of single-rooted premolars with asymptomatic apical periodontitis.",2022,The intra-group comparisons showed a significant reduction in post-operative pain with time (p<0.05) for both groups.,"['single-rooted mandibular premolars with asymptomatic apical periodontitis', 'Sixty-six patients']","['instrumentation kinematics (reciprocation or continuous rotation', 'kinematics of the shaping instrument: WaveOne Gold (WO) used in reciprocation or One Shape (OS) used in continuous rotation']","['post-operative pain', 'Bacterial Reduction, Post-Operative Pain and flare-ups', 'incidence of flare-ups', 'visual analog scale (VAS', 'bacterial reduction, post-operative pain and incidence of flare-ups', 'percentage of bacterial reduction', 'WOG or OS files']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0016094', 'cui_str': 'Filing'}]",66.0,0.0565624,The intra-group comparisons showed a significant reduction in post-operative pain with time (p<0.05) for both groups.,"[{'ForeName': 'Shehabeldin Mohamed', 'Initials': 'SM', 'LastName': 'Saber', 'Affiliation': 'Department of Endodontics, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Abdulrahman Mohammed Abdu', 'Initials': 'AMA', 'LastName': 'Alfadag', 'Affiliation': 'Department of Endodontics, Ibb University, Ibb, Yemen.'}, {'ForeName': 'Nawar Naguib', 'Initials': 'NN', 'LastName': 'Nawar', 'Affiliation': 'Department of Endodontics, The British University, El-Shorouk City, Egypt.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Plotino', 'Affiliation': 'Private Practice, Rome, Italy.'}, {'ForeName': 'Ehab El-Sayed', 'Initials': 'EE', 'LastName': 'Hassanien', 'Affiliation': 'Department of Endodontics, Ain Shams University, Cairo, Egypt.'}]",International endodontic journal,['10.1111/iej.13695']
1816,35101723,"Effect of water-based walking exercise on rehabilitation of patients following ACL reconstruction: a prospective, randomised, single-blind clinical trial.","OBJECTIVES


To compare water-based treadmill walking training with land-based treadmill walking training following anterior cruciate ligament (ACL) reconstruction.
DESIGN


Prospective, randomised, single-blind clinical trial.
SETTING


Single-centre study.
PARTICIPANTS


Sixty patients undergoing rehabilitation following ACL reconstruction were assigned at random into two groups.
INTERVENTIONS


Patients in the water-based training group (WBG) underwent treadmill training in water, and patients in the land-based training group (LBG) underwent treadmill training on land.
MAIN OUTCOME MEASURES


Muscle strength was evaluated using the ratio of peak torque to body weight (PT/BW) before and after 3 weeks of training.
RESULTS


After 3 weeks of training, both groups had significantly higher PT/BW ratios, passive position sense (PAPS) and Lysholm scores compared with pre-treatment levels. In the affected leg, the PT/BW ratio for the knee extensor muscles, PAPS and Lysholm scores showed significantly greater improvement in the WBG than in the LBG. No significant differences in the PT/BW ratio, single leg balance index and stability limit index of the knee flexor muscles at different angular velocities were seen between the two groups.
CONCLUSION


The results suggest that water-based walking exercise could lead to greater improvements in extensor muscle strength, proprioception and knee performance compared with land-based training following ACL reconstruction.
CLINICAL TRIAL REGISTRATION NUMBER


ChiCTR1900025930.",2021,"No significant differences in the PT/BW ratio, single leg balance index and stability limit index of the knee flexor muscles at different angular velocities were seen between the two groups.
","['anterior cruciate ligament (ACL) reconstruction', 'patients following ACL reconstruction', 'Single-centre study', 'Sixty patients undergoing rehabilitation following ACL reconstruction']","['Patients in the water-based training group (WBG) underwent treadmill training in water, and patients in the land-based training group (LBG) underwent treadmill training on land', 'water-based treadmill walking training with land-based treadmill walking training', 'water-based walking exercise']","['extensor muscle strength, proprioception and knee performance', 'ratio of peak torque to body weight (PT/BW', 'PT/BW ratios, passive position sense (PAPS) and Lysholm scores', 'PT/BW ratio, single leg balance index and stability limit index of the knee flexor muscles at different angular velocities']","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",60.0,0.0122316,"No significant differences in the PT/BW ratio, single leg balance index and stability limit index of the knee flexor muscles at different angular velocities were seen between the two groups.
","[{'ForeName': 'Desheng', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Rehabilitation, Affiliated Zhongshan Hospital of Dalian University, Dalian, People's Republic of China; Department of Rehabilitation, People's Hospital of Longhua District of Shenzhen, Shenzhen, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Rehabilitation, Affiliated Zhongshan Hospital of Dalian University, Dalian, People's Republic of China.""}, {'ForeName': 'Xuguang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Rehabilitation, Affiliated Zhongshan Hospital of Dalian University, Dalian, People's Republic of China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Department of Anatomy, Medical College of Dalian University, Dalian, People's Republic of China.""}, {'ForeName': 'Jiani', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""Department of Rehabilitation, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': ""Department of Rehabilitation, Affiliated Zhongshan Hospital of Dalian University, Dalian, People's Republic of China. Electronic address: shuiyan_1980@163.com.""}, {'ForeName': 'Yangjun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Rehabilitation, Affiliated Zhongshan Hospital of Dalian University, Dalian, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Rehabilitation, Affiliated Zhongshan Hospital of Dalian University, Dalian, People's Republic of China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Shen', 'Affiliation': ""Department of Rehabilitation, Affiliated Zhongshan Hospital of Dalian University, Dalian, People's Republic of China; Department of Rehabilitation, People's Hospital of Longhua District of Shenzhen, Shenzhen, People's Republic of China. Electronic address: PYF0404@126.com.""}]",Physiotherapy,['10.1016/j.physio.2021.11.003']
1817,34964230,"Microneedling combined with pimecrolimus, 5-fluorouracil, and trichloroacetic acid in the treatment of vitiligo: A comparative study.","Treatment of vitiligo represents a highly therapeutic challenge in spite of the continuous development of new modalities. Combination therapies of vitiligo can help improve treatment response, and reduce recurrence potential. To compare the efficacy and adverse effects of microneedling combined with-fluorouracil, pimecrolimus, and trichloroacetic acid (TCA) in the treatment of localized, stable vitiligo. The study included 75 patients with non-segmental, stable vitiligo who were randomly assigned to three equal groups: group received a combination of microneedling and -FU, group 2 received microneedling and pimecrolimus, and group 3 received microneedling and TCA. The procedure was done every 2 weeks for a maximum of six sessions. Combined microneedling and TCA was associated with the highest + 5-fluorouracil, and lastly combined microneedling + pimecrolimus. The difference between the three groups was statistically significant in favor of the combined microneedling and TCA. Pain, erythema, post-inflammatory hyperpigmentation, infection, and scarring were variably reported adverse effects in the three groups. Combination therapy seems to be a promising modality for the treatment of vitiligo. Combined microneedling and TCA is superior to combined microneedling with either-fluorouracil or pimecrolimus.",2022,"Combined microneedling and TCA was associated with the highest + 5-fluorouracil, and lastly combined microneedling + pimecrolimus.","['vitiligo', 'localized, stable vitiligo', '75 patients with non-segmental, stable vitiligo']","['microneedling combined with-fluorouracil, pimecrolimus, and trichloroacetic acid (TCA', 'combination of microneedling and -FU, group 2 received microneedling and pimecrolimus, and group 3 received microneedling and TCA', 'Combined microneedling and TCA', 'highest + 5-fluorouracil, and lastly combined microneedling + pimecrolimus', 'fluorouracil or pimecrolimus', 'pimecrolimus, 5-fluorouracil, and trichloroacetic acid']","['efficacy and adverse effects', 'Pain, erythema, post-inflammatory hyperpigmentation, infection, and scarring']","[{'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1099414', 'cui_str': 'Pimecrolimus'}, {'cui': 'C0040900', 'cui_str': 'Trichloroacetic acid'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]",75.0,0.0318651,"Combined microneedling and TCA was associated with the highest + 5-fluorouracil, and lastly combined microneedling + pimecrolimus.","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Nofal', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Eldeeb', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Shalaby', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Al-Balat', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Dermatologic therapy,['10.1111/dth.15294']
1818,35108265,"RAVAL trial: Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer.","BACKGROUND


Retrospective data demonstrates that robotic-assisted thoracoscopic surgery provides many benefits, such as decreased postoperative pain, lower mortality, shorter length of stay, shorter chest tube duration, and reductions in the incidence of common postoperative pulmonary complications, when compared to video-assisted thoracoscopic surgery. Despite the potential benefits of robotic surgery, there are two major barriers against its widespread adoption in thoracic surgery: lack of high-quality prospective data, and the perceived higher cost of it. Therefore, in the face of these barriers, a prospective randomized controlled trial comparing robotic- to video-assisted thoracoscopic surgery is needed. The RAVAL trial is a two-phase, international, multi-centered, blinded, parallel, randomized controlled trial that is comparing robotic- to video-assisted lobectomy for early-stage non-small cell lung cancer that has been enrolling patients since 2016.
METHODS


The RAVAL trial will be conducted in two phases: Phase A will enroll 186 early-stage non-small cell lung cancer patients who are candidates for minimally invasive pulmonary lobectomy; while Phase B will continue to recruit until 592 patients are enrolled. After consent, participants will be randomized in a 1:1 ratio to either robotic- or video-assisted lobectomy, and blinded to the type of surgery they are allocated to. Health-related quality of life questionnaires will be administered at baseline, postoperative day 1, weeks 3, 7, 12, months 6, 12, 18, 24, and years 3, 4, 5. The primary objective of the RAVAL trial is to determine the difference in patient-reported health-related quality of life outcomes between the robotic- and video-assisted lobectomy groups at 12 weeks. Secondary objectives include determining the differences in cost-effectiveness, and in the 5-year survival data between the two arms. The results of the primary objective will be reported once Phase A has completed accrual and the 12-month follow-ups are completed. The results of the secondary objectives will be reported once Phase B has completed accrual and the 5-year follow-ups are completed.
DISCUSSION


If successfully completed, the RAVAL Trial will have studied patient-reported outcomes, cost-effectiveness, and survival of robotic- versus video-assisted lobectomy in a prospective, randomized, blinded fashion in an international setting.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02617186. Registered 22-September-2015. https://clinicaltrials.gov/ct2/show/NCT02617186.",2022,"Secondary objectives include determining the differences in cost-effectiveness, and in the 5-year survival data between the two arms.","['186 early-stage non-small cell lung cancer patients who are candidates for minimally invasive pulmonary lobectomy', 'early-stage lung cancer', '592 patients are enrolled']","['robotic- to video-assisted lobectomy', 'robotic surgery', 'robotic- or video-assisted lobectomy', 'robotic-assisted versus video-assisted lobectomy', 'robotic-assisted thoracoscopic surgery', 'robotic- versus video-assisted lobectomy', 'robotic- to video-assisted thoracoscopic surgery']","['postoperative pain, lower mortality, shorter length of stay, shorter chest tube duration', 'Health-related quality of life questionnaires', 'cost-effectiveness, and in the 5-year survival data']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.58486,"Secondary objectives include determining the differences in cost-effectiveness, and in the 5-year survival data between the two arms.","[{'ForeName': 'Yogita S', 'Initials': 'YS', 'LastName': 'Patel', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Waël C', 'Initials': 'WC', 'LastName': 'Hanna', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Fahim', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Shargall', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Waddell', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yasufuku', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Tiago N', 'Initials': 'TN', 'LastName': 'Machuca', 'Affiliation': 'Division of Thoracic and Cardiovascular Surgery, Department of Surgery, University of Florida, Gainesville, Florida, United States of America.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Pipkin', 'Affiliation': 'Division of Thoracic and Cardiovascular Surgery, Department of Surgery, University of Florida, Gainesville, Florida, United States of America.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Baste', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Rouen Normandy University, Rouen Cedex, France.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Shiwcharan', 'Affiliation': ""Funding Reform and Case Costing, St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Foster', 'Affiliation': 'Department of Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.'}]",PloS one,['10.1371/journal.pone.0261767']
1819,35108378,Prolonged Glycemic Adaptation Following Transition From a Low- to High-Carbohydrate Diet: A Randomized Controlled Feeding Trial.,"OBJECTIVE


Consuming ≥150 g/day carbohydrate is recommended for 3 days before an oral glucose tolerance test (OGTT) for diabetes diagnosis. For evaluation of this recommendation, time courses of glycemic changes following transition from a very-low-carbohydrate (VLC) to high-carbohydrate diet were assessed with continuous glucose monitoring (CGM).
RESEARCH DESIGN AND METHODS


After achieving a weight loss target of 15% (±3%) on the run-in VLC diet, participants (18-50 years old, BMI ≥27 kg/m2) were randomly assigned for 10 weeks to one of three isoenergetic diets: VLC (5% carbohydrate and 77% fat); high carbohydrate, high starch (HC-Starch) (57% carbohydrate and 25% fat, including 20% refined grains); and high carbohydrate, high sugar (HC-Sugar) (57% carbohydrate and 25% fat, including 20% sugar). CGM was done throughout the trial (n = 64) and OGTT at start and end (n = 41). All food was prepared in a metabolic kitchen and consumed under observation.
RESULTS


Glucose metrics continued to decline after week 1 in the HC-Starch and HC-Sugar groups (P < 0.05) but not VLC. During weeks 2-5, fasting and 2-h glucose (millimoles per liter per week) decreased in HC-Starch (fasting -0.10, P = 0.001; 2 h -0.10, P = 0.04). During weeks 6-9, 2-h glucose decreased in HC-Starch (-0.07, P = 0.01) and fasting and 2-h glucose decreased in HC-Sugar (fasting -0.09, P = 0.001; 2 h -0.09, P = 0.003). The number of participants with abnormal glucose tolerance by OGTT remained 10 (of 16) in VLC at start and end but decreased from 17 to 9 (of 25) in both high-carbohydrate groups.
CONCLUSIONS


Physiological adaptation from a low- to high-carbohydrate diet may require many weeks, with implications for the accuracy of diabetes tests, interpretation of macronutrient trials, and risks of periodic planned deviations from a VLC diet.",2022,"RESULTS


Glucose metrics continued to decline after week 1 in the HC-Starch and HC-Sugar groups (P < 0.05) but not VLC.",[],"['Low- to High-Carbohydrate Diet', 'isoenergetic diets: VLC (5% carbohydrate and 77% fat); high carbohydrate, high starch (HC-Starch) (57% carbohydrate and 25% fat, including 20% refined grains); and high carbohydrate, high sugar (HC-Sugar) (57% carbohydrate and 25% fat, including 20% sugar', 'CGM']","['fasting and 2-h glucose decreased in HC-Sugar', 'HC-Starch', '2-h glucose decreased in HC-Starch', 'number of participants with abnormal glucose tolerance', 'Prolonged Glycemic Adaptation']",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0259835', 'cui_str': 'High carbohydrate diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C1704381', 'cui_str': 'Glucose decreased'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0235401', 'cui_str': 'Abnormal glucose tolerance'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]",,0.0370095,"RESULTS


Glucose metrics continued to decline after week 1 in the HC-Starch and HC-Sugar groups (P < 0.05) but not VLC.","[{'ForeName': 'Lisa T', 'Initials': 'LT', 'LastName': 'Jansen', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Nianlan', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'University of Alabama Birmingham, Birmingham, AL.'}, {'ForeName': 'Julia M W', 'Initials': 'JMW', 'LastName': 'Wong', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Mehta', 'Affiliation': 'University of Alabama Birmingham, Birmingham, AL.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Allison', 'Affiliation': 'Indiana University School of Public Health-Bloomington, Bloomington, IN.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Ludwig', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Cara B', 'Initials': 'CB', 'LastName': 'Ebbeling', 'Affiliation': ""New Balance Foundation Obesity Prevention Center, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}]",Diabetes care,['10.2337/dc21-1970']
1820,35109685,Magnitude of Blood Pressure Change After Endovascular Therapy and Outcomes: Insight From the BP-TARGET Trial.,"BACKGROUND AND PURPOSE


To assess the association between systolic blood pressure change (ΔSBP) at different time intervals after successful reperfusion with radiographic and clinical outcomes.
METHODS


This is a post hoc analysis of the BP-TARGET multicenter trial (Blood Pressure Target in Acute Stroke to Reduce Hemorrhage After Endovascular Therapy). ΔSBP was defined as end of procedure SBP minus mean SBP at different time intervals (15-60 minutes, 1-6 hours, and 6-24 hours postprocedure). The primary outcome was the poor functional outcome (90-day modified Rankin Scale score 3-6).
RESULTS


We included a total of 267 patients (130 in the intensive treatment group). Compared with patients with favorable outcome, patients with poor outcome had lower ΔSBP (less SBP reduction) at all times intervals. After adjusting for potential confounders including baseline SBP, both ΔSBP 15 -60M  and ΔSBP 6 -24H  were associated with lower odds of poor outcome (adjusted odds ratio per 5 mm Hg SBP reduction, 0.89 [95% CI, 0.81-0.99], and adjusted odds ratio 0.82 [95% CI, 0.73-0.92], respectively). Concerning safety outcomes, patients with intraparenchymal hemorrhage had lower ΔSBP at all time intervals. ΔSBP 15 -60M  was associated with lower odds of any intraparenchymal hemorrhage (adjusted odds ratio per 5 mm Hg SBP reduction 0.91 [95% CI, 0.83-0.99]). Conversely, ΔSBP was not associated with mortality or neurological deterioration at any time interval.
CONCLUSIONS


After successful reperfusion, ΔSBP had a linear relationship with poor outcome and the risk of poor outcome was higher with less reduction from the baseline SBP. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03160677.",2022,M  was associated with lower odds of any intraparenchymal hemorrhage (adjusted odds ratio per 5 mm Hg SBP reduction 0.91,"['267 patients (130 in the intensive treatment group', 'ΔSBP 15 -60', 'patients with intraparenchymal hemorrhage']",[],"['systolic blood pressure change (ΔSBP', 'poor functional outcome (90-day modified Rankin Scale score 3-6', 'intraparenchymal hemorrhage', 'Hemorrhage', 'ΔSBP', 'Blood Pressure Change', 'mortality or neurological deterioration']","[{'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",[],"[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}]",267.0,0.661849,M  was associated with lower odds of any intraparenchymal hemorrhage (adjusted odds ratio per 5 mm Hg SBP reduction 0.91,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Anadani', 'Affiliation': 'Department of Neurology, Washington University, St Louis, MO (M.A.).'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Maïer', 'Affiliation': 'Department of Interventional Neuroradiology, Hôpital Fondation Ophtalmologique Adolphe de Rothschild, Paris, France (B.M., S.E., J.-P.D., R.B., M.P., M.M.).'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Escalard', 'Affiliation': 'Department of Interventional Neuroradiology, Hôpital Fondation Ophtalmologique Adolphe de Rothschild, Paris, France (B.M., S.E., J.-P.D., R.B., M.P., M.M.).'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'University of Lille, CHU Lille, ULR 2694-METRICS: Évaluation des technologies de santé et des pratiques médicales, France (J.L.).'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'de Havenon', 'Affiliation': 'Department of Neurology, University of Utah, Salt Lake City (A.d.H.).'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Sabben', 'Affiliation': ''}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Division of Neurology, Department of Neurology, Stroke Centre, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France (B.L.).'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Gory', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Nancy, France (B.G.).'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Richard', 'Affiliation': ''}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Sibon', 'Affiliation': ''}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Desilles', 'Affiliation': 'University of Paris, France (B.M., J.-P.D., M.M.).'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Blanc', 'Affiliation': 'FHU Neurovasc, Paris, France (B.M., J.-P.D., R.B., M.P., M.M.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Piotin', 'Affiliation': 'FHU Neurovasc, Paris, France (B.M., J.-P.D., R.B., M.P., M.M.).'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Mazighi', 'Affiliation': 'Department of Interventional Neuroradiology, Hôpital Fondation Ophtalmologique Adolphe de Rothschild, Paris, France (B.M., S.E., J.-P.D., R.B., M.P., M.M.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.121.036701']
1821,34999246,Pharmacokinetic features of dolutegravir with rifampicin and rifabutin among patients coinfected with human immunodeficiency virus and tuberculosis/mycobacterium avium complex.,"BACKGROUND


Rifamycins are the cornerstone of anti-tuberculosis therapy while they are potent inducers of drug metabolizing enzymes. For the first time, we evaluated the effect of rifampicin (RIF) and rifabutin (RBT) on the pharmacokinetics (PK) of dolutegravir (DTG) in patients with HIV and tuberculosis (TB)/ mycobacterium avium complex (MAC) co-infection.
METHODS


Both HIV/TB (or MAC) co-infected patients and HIV infected patients without TB/MAC were enrolled. Patients in the RIF group received DTG 50 mg twice daily together with 600mg of RIF, while patients in the RBT group received DTG 50 mg once daily together with 300 mg of RBT. The DTG pharmacokinetic profiles in different groups were assessed.
RESULTS


A total of 13 subjects in the RIF group, 12 subjects in the RBT group, and 10 subjects in non-TB/MAC group were enrolled. The geometric mean ratio (GMR) of the trough concentration (Ctr) of DTG in the RIF group to non-TB/MAC group was 1.33 [90% confidence interval (CI):0.97 to 1.81], while the GMR of the maximum concentration (Cmax) of DTG was 1.29 (90% CI: 1.23 to 1.36). The GMR of the Ctr of DTG in the RBT group to non-TB/MAC group was 0.41 (90% CI: 0.30 to 0.57), while the GMR of the Cmax of DTG was 0.55 (90% CI: 0.52 to 0.57).
CONCLUSIONS


Due to the relatively low trough concentrations of DTG with RBT, DTG 50mg once daily together with RBT could only serve as an alternative option for HIV/TB (or MAC) co-infected patients.",2022,"The geometric mean ratio (GMR) of the trough concentration (Ctr) of DTG in the RIF group to non-TB/MAC group was 1.33 [90% confidence interval (CI):0.97 to 1.81], while the GMR of the maximum concentration (Cmax) of DTG was 1.29 (90% CI: 1.23 to 1.36).","['patients with HIV and tuberculosis (TB)/ mycobacterium avium complex (MAC) co-infection.\nMETHODS\n\n\nBoth HIV/TB (or MAC) co-infected patients and HIV infected patients without TB/MAC were enrolled', 'patients coinfected with human immunodeficiency virus and tuberculosis/mycobacterium avium complex', '13 subjects in the RIF group, 12 subjects in the RBT group, and 10 subjects in non-TB/MAC group were enrolled']","['rifampicin and rifabutin', 'rifampicin (RIF) and rifabutin (RBT', 'DTG', 'DTG 50 mg once daily together with 300 mg of RBT']","['pharmacokinetics (PK) of dolutegravir (DTG', 'GMR of the Cmax of DTG', 'geometric mean ratio (GMR) of the trough concentration (Ctr) of DTG', 'GMR of the Ctr of DTG', 'GMR of the maximum concentration (Cmax) of DTG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0026914', 'cui_str': 'Mycobacterium avium-intracellulare'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0140575', 'cui_str': 'Rifabutin'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",13.0,0.0509677,"The geometric mean ratio (GMR) of the trough concentration (Ctr) of DTG in the RIF group to non-TB/MAC group was 1.33 [90% confidence interval (CI):0.97 to 1.81], while the GMR of the maximum concentration (Cmax) of DTG was 1.29 (90% CI: 1.23 to 1.36).","[{'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Le', 'Affiliation': 'Department of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaoye', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""The Fifth People's Hospital of Wuxi City, Jiangsu Province.""}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Yinzhong', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiangrong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Tangkai', 'Initials': 'T', 'LastName': 'Qi', 'Affiliation': 'Department of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhenyan', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Scientific Research Center, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Scientific Research Center, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Renfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China. Electronic address: zhangrenfang@shphc.org.cn.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China. Electronic address: qtchenjun@163.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2022.01.001']
1822,35079071,Effect of vibration on orthodontic tooth movement in a double blind prospective randomized controlled trial.,"The purpose of the present study was to investigate the effect of vibration on orthodontic tooth movement and safety assessment based on our previous basic research in animal experiments. A double-blind prospective randomized controlled trial using split-mouth design was conducted in patients with malocclusion. The left and right sides of maxillary arch were randomly assigned to vibration (TM + V) and non-vibration (TM) groups. After leveling, vibrations (5.2 ± 0.5 g-forces (gf), 102.2 ± 2.6 Hertz (Hz)) were supplementary applied to the canine retracted with 100 gf in TM + V group for 3 min at the monthly visit under double-blind fashion, and the canine on the other side without vibration was used as TM group. The amount of tooth movement was measured blindly using a constructed three-dimensional dentition model. The amount of canine movement per visit was 0.89 ± 0.55 mm in TM group (n = 23) and 1.21 ± 0.60 mm in TM + V group (n = 23), respectively. There was no significant difference of pain and discomfort, and root resorption between the two groups. This study indicates that static orthodontic force with supplementary vibration significantly accelerated tooth movement in canine retraction and reduced the number of visits without causing side effects.",2022,"There was no significant difference of pain and discomfort, and root resorption between the two groups.",['patients with malocclusion'],"['vibration', 'vibration (TM\u2009+\u2009V) and non-vibration (TM']","['amount of tooth movement', 'pain and discomfort, and root resorption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024636', 'cui_str': 'Malocclusion'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}]","[{'cui': 'C0040446', 'cui_str': 'Orthodontic Tooth Movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0035851', 'cui_str': 'Root Resorption'}]",,0.164645,"There was no significant difference of pain and discomfort, and root resorption between the two groups.","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Mayama', 'Affiliation': 'Division of Orthodontics and Dentofacial Orthopedics, Graduate School of Dentistry, Tohoku University, 4-1, Seiryomachi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Seiryu', 'Affiliation': 'Division of Orthodontics and Dentofacial Orthopedics, Graduate School of Dentistry, Tohoku University, 4-1, Seiryomachi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan.'}, {'ForeName': 'Teruko', 'Initials': 'T', 'LastName': 'Takano-Yamamoto', 'Affiliation': 'Division of Orthodontics and Dentofacial Orthopedics, Graduate School of Dentistry, Tohoku University, 4-1, Seiryomachi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan. t-yamamo@m.tohoku.ac.jp.'}]",Scientific reports,['10.1038/s41598-022-05395-5']
1823,35042057,Talus mobilization-based manual therapy is effective for restoring range of motion and enhancing balance in older adults with limited ankle mobility: A randomized controlled trial.,"BACKGROUND


The ankle plays a key role in balance, but ankle range of motion decreases with ageing.
RESEARCH QUESTION


To establish whether a talus mobilization-based manual therapy intervention may be effective for increasing range of motion and balance in older adults with limited ankle mobility due to the ageing process.
METHODS


Randomized clinical trial in which 42 community-dwelling older adults with limited ankle mobility were allocated to an experimental or a control group. The experimental intervention consisted of six sessions of anteroposterior talus mobilization, whereas the control intervention was a sham treatment. Baseline change in weight and non-weight bearing ankle range of motion (ROM), balance outcome in terms of the Timed up and go (mobility and dynamic balance), Single-leg stand (static balance and stability), Functional reach (margins of stability) and Romberg tests (static balance) were assessed. Analysis of variance based on a mixed-linear model of repeated measures looked for group interactions.
RESULTS


Forty participants completed the study. Participants who received six sessions of manual therapy showed greater improvements in the Timed up and go, Functional reach and Single-leg stand tests than participants who received a sham intervention (p < 0.001). Both groups presented similar performance in post-treatment static balance measures (p > 0.05).
SIGNIFICANCE


An anteroposterior talus mobilization-based manual therapy intervention is effective for increasing ankle ROM, with a positive effect on dynamic balance, mobility and stability in community-dwelling older adults with limited ankle mobility.",2022,"Participants who received six sessions of manual therapy showed greater improvements in the Timed up and go, Functional reach and Single-leg stand tests than participants who received a sham intervention (p < 0.001).","['Forty participants completed the study', 'older adults', 'community-dwelling older adults with limited ankle mobility', 'older adults with limited ankle mobility', '42 community-dwelling older adults with limited ankle mobility']","['anteroposterior talus mobilization-based manual therapy intervention', 'talus mobilization-based manual therapy intervention', 'Talus mobilization-based manual therapy']","['Timed up and go, Functional reach and Single-leg stand tests', 'Baseline change in weight and non-weight bearing ankle range of motion (ROM), balance outcome in terms of the Timed up and go (mobility and dynamic balance), Single-leg stand (static balance and stability), Functional reach (margins of stability) and Romberg tests (static balance']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]","[{'cui': 'C0039277', 'cui_str': 'Bone structure of talus'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C1321046', 'cui_str': 'Single leg standing test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0278127', 'cui_str': 'Romberg sign'}]",42.0,0.0458479,"Participants who received six sessions of manual therapy showed greater improvements in the Timed up and go, Functional reach and Single-leg stand tests than participants who received a sham intervention (p < 0.001).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hernández-Guillén', 'Affiliation': 'Group of Physiotherapy in the Ageing Process, Social and Health Care Strategies. Department of Physiotherapy, Universitat de València, Calle Gascó Oliag nº5, 46010 Valencia, Spain; Department of Physiotherapy. Universitat de València, Calle Gascó Oliag nº5, 46010 Valencia, Spain. Electronic address: david.hernandez@uv.es.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Roig-Casasús', 'Affiliation': 'Group of Physiotherapy in the Ageing Process, Social and Health Care Strategies. Department of Physiotherapy, Universitat de València, Calle Gascó Oliag nº5, 46010 Valencia, Spain; Department of Physiotherapy. Universitat de València, Calle Gascó Oliag nº5, 46010 Valencia, Spain.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Tolsada-Velasco', 'Affiliation': 'Department of Physiotherapy. Universitat de València, Calle Gascó Oliag nº5, 46010 Valencia, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'García-Gomáriz', 'Affiliation': 'Department of Nursing, Universitat de València, Carrer de Jaume Roig, s/n, 46001 València, Spain.'}, {'ForeName': 'José-María', 'Initials': 'JM', 'LastName': 'Blasco', 'Affiliation': 'Group of Physiotherapy in the Ageing Process, Social and Health Care Strategies. Department of Physiotherapy, Universitat de València, Calle Gascó Oliag nº5, 46010 Valencia, Spain; Department of Physiotherapy. Universitat de València, Calle Gascó Oliag nº5, 46010 Valencia, Spain; IRIMED Joint Research Unit (IIS-LaFe - UV), Spain.'}]",Gait & posture,['10.1016/j.gaitpost.2022.01.005']
1824,35078438,The Patient Navigator: Can a systematically developed online health information tool improve patient participation and outcomes related to the consultation in older patients newly diagnosed with colorectal cancer?,"BACKGROUND


Older cancer patients may search for health information online to prepare for their consultations. However, seeking information online can have negative effects, for instance increased anxiety due to finding incorrect or unclear information. In addition, existing online cancer information is not necessarily adapted to the needs of older patients, even though cancer is a disease often found in older individuals.
OBJECTIVE


The aim of this study was to systematically develop, implement and evaluate an online health information tool for older cancer patients, the Patient Navigator, providing information that complements the consultation with healthcare providers.
METHOD


For the development and evaluation of the Patient Navigator, the four phases of the MRC framework were used. In the first and second phase the Patient Navigator was developed and pilot tested based on previous research and sub-studies. During the third phase the Patient Navigator was implemented in four Dutch hospitals. In the last phase, a pilot RCT was conducted to evaluate the Patient Navigator in terms of usage (observational tracking data), user experience (self-reported satisfaction, involvement, cognitive load, active control, perceived relevance of the tool), patient participation (observational data during consultation), and patient outcomes related to the consultation (questionnaire data regarding anxiety, satisfaction, and information recall). Recently diagnosed colorectal cancer patients (N = 45) were randomly assigned to the control condition (usual care) or the experimental condition (usual care + Patient Navigator).
RESULTS


The Patient Navigator was well used and evaluated positively. Patients who received the Patient Navigator contributed less during the consultation by using less words than patients in the control condition and experienced less anxiety two days after the consultation than patients in the control condition.
CONCLUSION


Since the Patient Navigator was evaluated positively and decreased anxiety after the consultation, this tool is potentially a valuable addition to the consultation for patients. Usage of the Patient Navigator resulted in patients using less words during consultations, without impairing patients' satisfaction, possibly because information needs might be fulfilled by usage of the Patient Navigator. This could create the possibility to personalize communication during consultations and respond to other patient needs.",2022,"Patients who received the Patient Navigator contributed less during the consultation by using less words than patients in the control condition and experienced less anxiety two days after the consultation than patients in the control condition.
","['older patients newly diagnosed with colorectal cancer', 'Older cancer patients', 'older cancer patients', 'diagnosed colorectal cancer patients (N = 45']",['control condition (usual care) or the experimental condition (usual care + Patient Navigator'],"['consultation (questionnaire data regarding anxiety, satisfaction, and information recall']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1709488', 'cui_str': 'Patient navigator'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",45.0,0.0268114,"Patients who received the Patient Navigator contributed less during the consultation by using less words than patients in the control condition and experienced less anxiety two days after the consultation than patients in the control condition.
","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'de Looper', 'Affiliation': 'Amsterdam School of Communication Research/ASCoR, University of Amsterdam, 1018, Amsterdam, WV, Netherlands. m.delooper@uva.nl.'}, {'ForeName': 'Ellen M A', 'Initials': 'EMA', 'LastName': 'Smets', 'Affiliation': 'Department of Medical Psychology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Schouten', 'Affiliation': 'Amsterdam School of Communication Research/ASCoR, University of Amsterdam, 1018, Amsterdam, WV, Netherlands.'}, {'ForeName': 'Sifra', 'Initials': 'S', 'LastName': 'Bolle', 'Affiliation': 'Centre for Health and Society, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.'}, {'ForeName': 'Eric H J', 'Initials': 'EHJ', 'LastName': 'Belgers', 'Affiliation': 'Zuyderland Medical Center, Sittard, Geleen, The Netherlands.'}, {'ForeName': 'Eric H', 'Initials': 'EH', 'LastName': 'Eddes', 'Affiliation': 'Department of Surgery, Deventer Hospital, Deventer, The Netherlands.'}, {'ForeName': 'Jeroen W A', 'Initials': 'JWA', 'LastName': 'Leijtens', 'Affiliation': 'Laurentius Hospital, Roermond, The Netherlands.'}, {'ForeName': 'Julia C M', 'Initials': 'JCM', 'LastName': 'van Weert', 'Affiliation': 'Amsterdam School of Communication Research/ASCoR, University of Amsterdam, 1018, Amsterdam, WV, Netherlands.'}]",BMC cancer,['10.1186/s12885-021-09096-6']
1825,35099602,The short-term outcome of distal mesogastric fixation after laparoscopic sleeve gastrectomy: a randomized controlled trial.,"PURPOSE


The proposed etiology of leakage after laparoscopic sleeve gastrectomy may be the axial rotation of the stomach owing to the loss of abdominal ligament fixation along the greater curvature of the stomach. The mechanism of increased intra-gastric pressure due to axial gastric rotation may place a great deal of stress on the staple lines, leading to an increased incidence of leakage. Other complications may occur, including vomiting, food intolerance or persistent reflux.
METHODS


This study was registered in ClinicalTrials.gov (ID: NCT04834323). This study included patients who were admitted to our center to undergo laparoscopic sleeve gastrectomy. Cases were collected in the period from December 2019 to December 2020. The study population included 83 patients, who were divided into the following two groups: Group 1 included 42 patients who received distal mesogastric fixation after laparoscopic sleeve gastrectomy; Group 2 included 41 patients who received laparoscopic sleeve gastrectomy alone without distal mesogastric fixation.
RESULTS


No leakage or axial rotation occurs after laparoscopic sleeve gastrectomy with distal fixation, while in patients without distal fixation, leakage and axial rotation occurred with no statistically significant differences between the two groups. Leakage and axial rotation occurred two times more frequently among patients who received laparoscopic sleeve gastrectomy without distal fixations.
CONCLUSION


Distal mesogastric fixation after laparoscopic sleeve gastrectomy decreased the axial gastric rotation and subsequently decreased gastric leakage.",2022,"Leakage and axial rotation occurred two times more frequently among patients who received laparoscopic sleeve gastrectomy without distal fixations.
","['patients who were admitted to our center to undergo', '83 patients, who were divided into the following two groups: Group 1 included 42 patients who received']","['laparoscopic sleeve gastrectomy', 'Distal mesogastric fixation after laparoscopic sleeve gastrectomy', 'distal mesogastric fixation after laparoscopic sleeve gastrectomy', 'laparoscopic sleeve gastrectomy alone without distal mesogastric fixation', 'laparoscopic sleeve gastrectomy with distal fixation']","['distal mesogastric fixation', 'gastric leakage', 'axial gastric rotation', 'Leakage and axial rotation', 'distal fixation, leakage and axial rotation', 'vomiting, food intolerance or persistent reflux', 'leakage or axial rotation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0149696', 'cui_str': 'Intolerance to food'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}]",,0.0583719,"Leakage and axial rotation occurred two times more frequently among patients who received laparoscopic sleeve gastrectomy without distal fixations.
","[{'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Negm', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt. said.negm@outlook.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Amin', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shafiq', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Baher', 'Initials': 'B', 'LastName': 'Atef', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Yassin', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Farag', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Surgery today,['10.1007/s00595-022-02459-x']
1826,35045374,Motor skill training versus strength and flexibility exercise in people with chronic low back pain: Preplanned analysis of effects on kinematics during a functional activity.,"BACKGROUND


People with chronic low back pain display the altered movement pattern where the lumbar spine moves more readily into its available range of motion relative to other joints. A logical approach to treatment, therefore, would be to improve this pattern during functional activities.
METHODS


154 participants were randomized to receive 6 weeks of motor skill training or strength and flexibility exercise. Participants in the motor skill training group received person-specific training to modify their altered movement pattern during functional activities. Participants in the strength and flexibility group received exercises for trunk strength and trunk and lower-limb flexibility. At baseline, post-treatment and 6-months after treatment participants performed a test of picking up an object using their preferred pattern. Three-dimensional marker co-ordinate data were collected. A mixed-model repeated measures analysis of variance was used to examine the treatment group and time effects.
FINDINGS


Motor skill training: Baseline early excursion values [mean (confidence interval)] were as follows: knee = 11.1°(8.0,4.1), hip = 21.2°(19.2,23.1), lumbar = 11.3°(10.4,12.3). From baseline to post-treatment significant improvements in early excursion included: knee = +18.6°(15.4,21.8), hip = +10.8°(8.8,12.8), and lumbar = -2.0°(-0.1,-4.0). There were no significant changes from post-treatment to 6-month follow-up. Strength and flexibility exercise: Baseline early excursion values were as follows: knee = 8.9°(5.8,11.9), hip = 20.8°(18.9,22.8), and lumbar = 11.2°(10.3,12.2) early excursion. There were no significant changes for knee, hip, and lumbar early excursion.
INTERPRETATION


Motor skill training was more effective than strength and flexibility exercise at changing and maintaining change to the altered movement pattern during a functional activity test of picking up an object.",2022,"There were no significant changes for knee, hip, and lumbar early excursion.
","['knee\xa0=\xa08.9°(5.8,11.9), hip\xa0=\xa020.8°(18.9,22.8), and lumbar\xa0=\xa011.2°(10.3,12.2) early excursion', 'Motor skill training', 'hip\xa0', '154 participants', 'people with chronic low back pain', 'knee\xa0']","['Strength and flexibility exercise', 'motor skill training or strength and flexibility exercise', 'Motor skill training versus strength and flexibility exercise', 'motor skill training group received person-specific training']","['knee, hip, and lumbar early excursion']","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",154.0,0.0391187,"There were no significant changes for knee, hip, and lumbar early excursion.
","[{'ForeName': 'Quenten L', 'Initials': 'QL', 'LastName': 'Hooker', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'Lanier', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis, MO, United States of America; Department of Orthopaedic Surgery, Washington University School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Roles', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'van Dillen', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis, MO, United States of America; Department of Orthopaedic Surgery, Washington University School of Medicine, St. Louis, MO, United States of America. Electronic address: vandillenl@wustl.edu.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2021.105570']
1827,34915762,Psilocybin microdosing does not affect emotion-related symptoms and processing: A preregistered field and lab-based study.,"BACKGROUND


Microdoses of psychedelics (i.e. a sub-hallucinogenic dose taken every third day) can reduce symptoms of depression, anxiety and stress according to anecdotal reports and observational studies. Research with medium to high doses of psilocybin points towards potential underlying mechanisms, including the modulation of emotion and interoceptive processing.
AIMS


In this preregistered study, we investigated whether psilocybin microdoses alter self-reported interoceptive awareness and whether repeated microdosing over 3 weeks modulates emotion processing and reduces symptoms of anxiety and depression.
METHODS


We used a double-blind, placebo-controlled, within-subject crossover design. Participants completed the Multidimensional Assessment of Interoceptive Awareness Questionnaire 1½ h after self-administering their second dose (or placebo), and the emotional go/no-go task and the shortened Depression Anxiety Stress Scale 1½ h after self-administering their seventh dose.
RESULTS


Our confirmatory analyses revealed that psilocybin microdosing did not affect emotion processing or symptoms of anxiety and depression compared with placebo. Our exploratory analyses revealed that psilocybin microdosing did not affect self-reported interoceptive awareness, that symptoms of depression and stress were significantly reduced in the first block compared with baseline, that participants broke blind in the second block and that there was no effect of expectations. Further research in a substance-naïve population with clinical range anxiety and depressive symptoms is needed to substantiate the potential beneficial effects of microdosing.",2022,Our confirmatory analyses revealed that psilocybin microdosing did not affect emotion processing or symptoms of anxiety and depression compared with placebo.,[],"['Psilocybin', 'psilocybin', 'Interoceptive Awareness Questionnaire 1½\u2009h after self-administering their second dose (or placebo), and the emotional go/no-go task and the shortened Depression Anxiety Stress Scale 1½\u2009h after self-administering their seventh dose', 'placebo']","['symptoms of depression and stress', 'emotion processing or symptoms of anxiety and depression']",[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.143211,Our confirmatory analyses revealed that psilocybin microdosing did not affect emotion processing or symptoms of anxiety and depression compared with placebo.,"[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Marschall', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Fejer', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Lempe', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Prochazkova', 'Affiliation': 'Department of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kuchar', 'Affiliation': 'Forensic Laboratory of Biologically Active Substances, Department of Chemistry of Natural Compounds, University of Chemistry and Technology Prague, Prague, Czech Republic.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Hajkova', 'Affiliation': 'Forensic Laboratory of Biologically Active Substances, Department of Chemistry of Natural Compounds, University of Chemistry and Technology Prague, Prague, Czech Republic.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'van Elk', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/02698811211050556']
1828,34952402,"Associations between cervical dilatation on admission and mode of delivery, a cohort study of Norwegian nulliparous women.","OBJECTIVE


To investigate associations between cervical dilatation at hospital admission and mode of delivery.
METHODS


A cohort study with data from a cluster-randomised controlled trial, the Labour Progression Study. The study population of 6511 nulliparous women with a singleton fetus in cephalic presentation with spontaneous onset of labour at term, was divided into two groups: <4 cm and ≥ 4 cm cervical dilatation on admission. Binary logistic regression comparing mode of delivery was used to estimate crude and adjusted OR with associated 95% CI.
RESULTS


Of the total study population, 56.7% were admitted with < 4 cm cervical dilatation and 43.3% with ≥ 4 cm. Women admitted with ≥ 4 cm had a significantly higher chance of spontaneous delivery, with adjusted OR of 1.28 (95% CI: 1.14-1.44), and a significantly lower risk of caesarean sections, with an adjusted OR of 0.51 (95% CI: 0.41-0.64). For operative vaginal delivery, there were no significant difference between the study groups. Intrapartum interventions as epidural analgesia and augmentation with oxytocin were lower among women admitted with ≥ 4 cm cervical dilatation.
CONCLUSION


The study found a significantly higher chance of spontaneous delivery among women admitted with ≥ 4 cm. More research is needed to investigate why so many women are admitted early in labour, and how these women can be better cared for to increase their chances of a spontaneous delivery.",2022,"For operative vaginal delivery, there were no significant difference between the study groups.","['women admitted with\xa0≥\xa04\xa0cm', 'Of the total study population', 'women admitted with\xa0≥\xa04\xa0cm cervical dilatation', '6511 nulliparous women with a singleton fetus in cephalic presentation with spontaneous onset of labour at term', 'Norwegian nulliparous women']","['epidural analgesia and augmentation with oxytocin', '4 cm and\xa0≥\xa04\xa0cm cervical dilatation on admission']","['chance of spontaneous delivery', 'risk of caesarean sections']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0233150', 'cui_str': 'Cervical dilatation, 4cm'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}]","[{'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0233150', 'cui_str': 'Cervical dilatation, 4cm'}, {'cui': 'C0457453', 'cui_str': 'On admission'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",6511.0,0.0955229,"For operative vaginal delivery, there were no significant difference between the study groups.","[{'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Gjærum', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, PO-box 4, St. Olavs plass, 0130 Oslo, Norway. Electronic address: ragnhild.gjarum@gmail.com.'}, {'ForeName': 'Ingvild Haarklau', 'Initials': 'IH', 'LastName': 'Johansen', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, PO-box 4, St. Olavs plass, 0130 Oslo, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Øian', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital of North Norway, 9038 Tromsø, Norway.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Bernitz', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, PO-box 4, St. Olavs plass, 0130 Oslo, Norway; Department of Obstetrics and Gynaecology, Østfold Hospital Trust, PO-box 300, 1714 Grålum, Norway.'}, {'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Dalbye', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, PO-box 4, St. Olavs plass, 0130 Oslo, Norway; Department of Obstetrics and Gynaecology, Østfold Hospital Trust, PO-box 300, 1714 Grålum, Norway.'}]",Sexual & reproductive healthcare : official journal of the Swedish Association of Midwives,['10.1016/j.srhc.2021.100691']
1829,35078021,Cross-education effect of 4-week high- or low-intensity static stretching intervention programs on passive properties of plantar flexors.,"This study aimed to compare the cross-education effect of unilateral stretching intervention programs with two different intensities (high- vs. low-intensity) on dorsiflexion range of motion (DF ROM), muscle stiffness, and muscle architecture following a 4-week stretching intervention. Twenty-eight healthy males were randomly allocated into two groups: a high-intensity static stretching (HI-SS) intervention group (n = 14; stretch intensity 6-7 out of 10) and a low-intensity static stretching (LI-SS) intervention group (n = 14; stretch intensity 0-1 out of 10). The participants were asked to stretch their dominant leg (prefer to kick a ball) for 4 weeks (3 × week for 3 × 60 s). Before and after the intervention, the non-trained leg passive properties (DF ROM, passive torque, and muscle stiffness) of the plantar flexors and the muscle architecture of the gastrocnemius medialis (muscle thickness, pennation angle, and fascicle length) were measured. Non-trained DF ROM and passive torque at DF ROM were significantly increased in the HI-SS group (p < 0.01, d = 0.64, 50.6%, and p = 0.044, d = 0.36, 18.2%, respectively), but not in the LI-SS group. Moreover, there were no significant changes in muscle stiffness and muscle architecture in both groups. For rehabilitation settings, a high-intensity SS intervention is required to increase the DF ROM of the non-trained limb. However, the increases in DF ROM seem to be related to changes in stretch tolerance and not to changes in muscle architecture or muscle stiffness.",2022,"Moreover, there were no significant changes in muscle stiffness and muscle architecture in both groups.",['Twenty-eight healthy males'],"['4-week high- or low-intensity static stretching intervention programs', 'high-intensity static stretching (HI-SS) intervention group (n\xa0=\xa014; stretch intensity 6-7 out of 10) and a low-intensity static stretching (LI-SS) intervention group (n\xa0=\xa014; stretch intensity 0-1 out of 10', 'unilateral stretching intervention programs with two different intensities (high- vs. low-intensity']","['DF ROM', 'non-trained leg passive properties (DF ROM, passive torque, and muscle stiffness) of the plantar flexors and the muscle architecture of the gastrocnemius medialis (muscle thickness, pennation angle, and fascicle length', 'dorsiflexion range of motion (DF ROM), muscle stiffness, and muscle architecture', 'muscle stiffness and muscle architecture', 'passive properties of plantar flexors', 'trained DF ROM and passive torque at DF ROM']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",28.0,0.0123948,"Moreover, there were no significant changes in muscle stiffness and muscle architecture in both groups.","[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Niigata 950-3198, Japan. Electronic address: masatoshi-nakamura@nuhw.ac.jp.'}, {'ForeName': 'Riku', 'Initials': 'R', 'LastName': 'Yoshida', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Niigata 950-3198, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Niigata 950-3198, Japan; Department of Rehabilitation, Matsumura General Hospital, 1-1 Kotaroumachi, Taira, Iwaki City, Fukushima 970-8026, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Yahata', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Niigata 950-3198, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Murakami', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, Niigata City, Niigata 950-3198, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Kasahara', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, Niigata City, Niigata 950-3198, Japan.'}, {'ForeName': 'Taizan', 'Initials': 'T', 'LastName': 'Fukaya', 'Affiliation': 'Department of Rehabilitation, Kyoto Kujo Hospital, 10 Karahashirajoumoncho, Minami-ku, Kyoto 601-8453, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Physical Therapy, Faculty of Rehabilitation, Kobe International University, Kobe City, Hyogo 658-0032, Japan.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory. Physical Education and Sport Center, Londrina State University, Brazil.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Konrad', 'Affiliation': 'Institute of Human Movement Science, Sport and Health, University of Graz, Mozartgasse 14, 8010 Graz, Austria.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2022.110958']
1830,35104057,Postoperative changes in cognition and cerebrospinal fluid neurodegenerative disease biomarkers.,"OBJECTIVE


Numerous investigators have theorized that postoperative changes in Alzheimer's disease neuropathology may underlie postoperative neurocognitive disorders. Thus, we determined the relationship between postoperative changes in cognition and cerebrospinal (CSF) tau, p-tau-181p, or Aβ levels after non-cardiac, non-neurologic surgery in older adults.
METHODS


Participants underwent cognitive testing before and 6 weeks after surgery, and lumbar punctures before, 24 h after, and 6 weeks after surgery. Cognitive scores were combined via factor analysis into an overall cognitive index. In total, 110 patients returned for 6-week postoperative testing and were included in the analysis.
RESULTS


There was no significant change from before to 24 h or 6 weeks following surgery in CSF tau (median [median absolute deviation] change before to 24 h: 0.00 [4.36] pg/mL, p = 0.853; change before to 6 weeks: -1.21 [3.98] pg/mL, p = 0.827). There were also no significant changes in CSF p-tau-181p or Aβ over this period. There was no change in cognitive index (mean [95% CI] 0.040 [-0.018, 0.098], p = 0.175) from before to 6 weeks after surgery, although there were postoperative declines in verbal memory (-0.346 [-0.523, -0.170], p = 0.003) and improvements in executive function (0.394, [0.310, 0.479], p < 0.001). There were no significant correlations between preoperative to 6-week postoperative changes in cognition and CSF tau, p-tau-181p, or Aβ42 changes over this interval (p > 0.05 for each).
INTERPRETATION


Neurocognitive changes after non-cardiac, non-neurologic surgery in the majority of cognitively healthy, community-dwelling older adults are unlikely to be related to postoperative changes in AD neuropathology (as assessed by CSF Aβ, tau or p-tau-181p levels or the p-tau-181p/Aβ or tau/Aβ ratios).
TRIAL REGISTRATION


clinicaltrials.gov (NCT01993836).",2022,"There were no significant correlations between preoperative to 6-week postoperative changes in cognition and CSF tau, p-tau-181p, or Aβ42 changes over this interval (p > 0.05 for each).
","['110 patients returned for 6-week postoperative testing and were included in the analysis', 'older adults', 'cognitively healthy, community-dwelling older adults']",[],"['postoperative changes in cognition and cerebrospinal (CSF) tau, p-tau-181p, or Aβ levels', 'executive function', 'cognition and CSF tau', 'cognitive index', 'Cognitive scores', 'postoperative declines in verbal memory']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}]",110.0,0.376189,"There were no significant correlations between preoperative to 6-week postoperative changes in cognition and CSF tau, p-tau-181p, or Aβ42 changes over this interval (p > 0.05 for each).
","[{'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Berger', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Browndyke', 'Affiliation': 'Center for the Study of Aging and Human Development, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Cooter Wright', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Nobuhara', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Reese', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Acker', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'W Michael', 'Initials': 'WM', 'LastName': 'Bullock', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Colin', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Devinney', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Eugene W', 'Initials': 'EW', 'LastName': 'Moretti', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Judd W', 'Initials': 'JW', 'LastName': 'Moul', 'Affiliation': 'Urology Division, Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Ohlendorf', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Laskowitz', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Waligorska', 'Affiliation': 'Department of Pathology and Lab Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Shaw', 'Affiliation': 'Department of Pathology and Lab Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Whitson', 'Affiliation': 'Center for the Study of Aging and Human Development, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': 'Center for the Study of Aging and Human Development, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Mathew', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of clinical and translational neurology,['10.1002/acn3.51499']
1831,35078116,Sustained seizure freedom with adjunctive perampanel in patients with convulsive seizures: Post hoc analysis of open-label extension studies 307 and 332.,"OBJECTIVE


Since increased mortality rates have been associated with convulsive seizures, it is important to achieve seizure control in these patients. Here, we report post hoc analyses to assess long-term seizure-freedom rates with adjunctive perampanel in patients (aged ≥ 12 years) with refractory focal to bilateral tonic-clonic seizures (FBTCS) or generalized tonic-clonic seizures (GTCS) who participated in open-label extension (OLEx) studies.
METHODS


Patients with focal-onset seizures, with/without FBTCS, who completed double-blind, Phase III Studies 304, 305, or 306 could enter OLEx Study 307 (16-week blinded Conversion; 256-week Maintenance). Patients with GTCS who completed the double-blind phase of Study 332 could enter the OLEx Phase (6-week blinded Conversion; 136-week Maintenance). Maximum perampanel dose: 12 mg/day. Seizure-freedom rates for up to 24 months were assessed in perampanel-treated patients who achieved seizure freedom during the double-blind studies to determine if their seizure-free status was maintained during the OLEx. In addition, to ensure any patients who only achieved seizure freedom during the OLEx were captured, seizure-freedom rates were also assessed in all patients who achieved and maintained a seizure-free status for a period of at least six consecutive months at any time during the double-blind and/or OLEx studies; some of these patients may have received placebo during the double-blind study but only their time on perampanel is included in the seizure-free analysis. Univariate and multivariate analyses were used to identify predictive factors for achieving seizure freedom for at least 6 months. Treatment-emergent adverse events (TEAEs) were assessed.
RESULTS


Overall, 53.8% (n = 42/78) of patients who received perampanel and were FBTCS free during the double-blind studies remained seizure free for up to 24 months during Study 307, and 31.6% (n = 6/19) of patients who were GTCS free during the double-blind phase of Study 332 remained seizure free for up to 24 months during the OLEx Phase. Over 40% (FBTCS, 41.5% [n = 197/475]; GTCS, 52.9% [n = 73/138]) of patients were seizure free for a period of at least six consecutive months. Multivariate analysis showed that the best predictors of achieving seizure freedom from FBTCS for at least 6 months were lower baseline seizure frequency (p = 0.0014) and absence of enzyme-inducing anti-seizure medications at baseline (p = 0.0056); multivariate analysis was not conducted for GTCS since only one variable was identified as a significant predictor of seizure freedom in the univariate analysis (lower baseline seizure frequency). Perampanel was generally well tolerated with no new safety signals identified. The most common TEAE was dizziness. For both seizure types, 10% or fewer seizure-free patients discontinued perampanel due to TEAEs.
CONCLUSIONS


These results suggest that adjunctive perampanel may be a suitable long-term treatment option for patients (aged ≥ 12 years) with convulsive seizures to achieve and maintain seizure freedom.",2022,Seizure-freedom rates for up to 24 months were assessed in perampanel-treated patients who achieved seizure freedom during the double-blind studies to determine if their seizure-free status was maintained during the OLEx.,"['patients with convulsive seizures', 'Patients with GTCS who completed the double-blind phase of Study 332 could enter the OLEx Phase (6-week blinded Conversion; 136-week Maintenance', 'patients (aged\u202f≥\u202f12\u202fyears) with convulsive seizures', 'Patients with focal-onset seizures, with/without FBTCS, who completed double-blind, Phase III Studies 304, 305, or 306 could enter OLEx Study 307 (16-week blinded Conversion; 256-week Maintenance', 'patients (aged\u202f≥\u202f12\u202fyears) with refractory focal to bilateral tonic-clonic seizures (FBTCS) or generalized tonic-clonic seizures (GTCS) who participated in open-label extension (OLEx) studies']","['placebo', 'Perampanel', 'adjunctive perampanel', 'perampanel']","['absence of enzyme-inducing anti-seizure medications', 'seizure freedom', 'dizziness', 'baseline seizure frequency', 'seizure-freedom rates', 'Seizure-freedom rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751494', 'cui_str': 'Seizures, Convulsive'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2698764', 'cui_str': 'perampanel'}]","[{'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}]",,0.699834,Seizure-freedom rates for up to 24 months were assessed in perampanel-treated patients who achieved seizure freedom during the double-blind studies to determine if their seizure-free status was maintained during the OLEx.,"[{'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Resnick', 'Affiliation': ""Department of Neurology, Brain Institute, Nicklaus Children's Hospital, 3200 SW 60 Court #302, Miami, FL 33155, United States. Electronic address: Trevor.Resnick@Nicklaushealth.org.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Europe Ltd., Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom.'}, {'ForeName': 'Leock Y', 'Initials': 'LY', 'LastName': 'Ngo', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ 07677, United States.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ 07677, United States.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.108528']
1832,35102808,IMproving Physical ACtivity after stroke via Treadmill training ( IMPACT ) and self-management: A randomized trial.,"AIM


To determine if treadmill training embedded in self-management education commencing during stroke inpatient rehabilitation results in more physical activity than usual gait training.
METHOD


A prospective, parallel-group, randomized trial with concealed allocation, blinded measurement, and intention-to-treat analysis involving 119 stroke survivors undergoing rehabilitation who were able to walk independently was undertaken. The experimental group undertook treadmill training (40-60% heart rate reserve) and self-management education for 30 min, three times a week for 8 weeks, and the control group undertook the same amount of usual gait training. Outcomes were measured at baseline (Week 0), on completion of the intervention (Week 8), and beyond the intervention (Week 26). The primary outcome was physical activity measured as steps/day using an activity monitor. Secondary outcomes were walking ability, cardiorespiratory fitness, cardiovascular risk, depression, self-efficacy, perception of physical activity, participation, and quality of life.
RESULTS


After 8 weeks, the experimental group took 1436 more steps/day (95% confidence interval (CI) = 229 to 2643) than the control group. By 6 months, they took 871 more steps/day (95% CI -385 to 2129) than the control group. There was no difference between groups in any other outcome.
CONCLUSION


In individuals undergoing rehabilitation after stroke, 8 weeks of treadmill training embedded in self-management resulted in more physical activity than usual gait training and this was largely maintained at 6 months, despite little effect on walking or cardiorespiratory fitness, suggesting the self-management was responsible.",2022,"After 8 weeks, the experimental group took 1436 more steps/day (95% CI 229 to 2643) than the control group.","['individuals undergoing rehabilitation after stroke', '119 stroke survivors undergoing rehabilitation who were able to walk independently was undertaken']","['usual gait training', 'treadmill training embedded in self-management education', 'treadmill training embedded in self-management', 'treadmill training (40-60% heart rate reserve) and self-management education', 'stroke via Treadmill training (IMPACT) and self-management']","['walking ability, cardiorespiratory fitness, cardiovascular risk, depression, self-efficacy, perception of physical activity, participation, and quality of life', 'physical activity measured as steps/day using an activity monitor', 'physical activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C2712089', 'cui_str': 'Able to walk'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}]",,0.0276834,"After 8 weeks, the experimental group took 1436 more steps/day (95% CI 229 to 2643) than the control group.","[{'ForeName': 'Sandra G', 'Initials': 'SG', 'LastName': 'Brauer', 'Affiliation': 'The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Kuys', 'Affiliation': 'Australian Catholic University, Banyo, QLD, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ada', 'Affiliation': 'The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Paratz', 'Affiliation': 'The University of Queensland, Brisbane, QLD, Australia.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/17474930221078121']
1833,35033423,Effects of Bilwa-Lajadi syrup in emesis gravidarum - an exploratory single arm open labeled trial.,"BACKGROUND


Emesis gravidarum is a common obstetrical problem affecting 50-80% of pregnant women during their first trimester which begins in the morning and frequently continues throughout the day; considered as one of the Vyakta Garbha Lakshana in Ayurveda. If it is not treated effectively in time; it may lead to complications in pregnancy affecting the quality of life and thus the pregnancy outcome.
OBJECTIVE


To evaluate the clinical effectiveness of Bilwa-Lajadi syrup in emesis gravidarum.
MATERIAL AND METHODS


A single arm open labeled clinical trial was conducted on 30 participants fulfilling the inclusion criteria from OPD and IPD of Prasuti Tantra Evam StreeRoga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan and administered with Bilwa-Lajadi Syrup 20 ml per day in two divided doses, empty stomach before food for 30 days with followed up every 15 days during treatment and 15 days after completion of trial period.
RESULTS


The drug showed statistically significant effect in reducing the frequency of vomiting per day, quantity of vomitus, aversion to smell, nausea and anorexia, altered content of vomitus, improved appetite, imparted lightness of body and increased haemoglobin gm%.
CONCLUSION


Thus, early medication with Bilwa-Lajadi syrup and following dietetic regimen played a vital role in relieving the symptoms of emesis gravidarum.",2022,"The drug showed statistically significant effect in reducing the frequency of vomiting per day, quantity of vomitus, aversion to smell, nausea and anorexia, altered content of vomitus, improved appetite, imparted lightness of body and increased haemoglobin gm%.
","['30 participants fulfilling the inclusion criteria from OPD and IPD of Prasuti Tantra Evam StreeRoga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan and administered with']","['Bilwa-Lajadi syrup', 'Bilwa-Lajadi Syrup 20\xa0ml per day in two divided doses, empty stomach']","['frequency of vomiting per day, quantity of vomitus, aversion to smell, nausea and anorexia, altered content of vomitus, improved appetite, imparted lightness of body and increased haemoglobin gm']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0025122', 'cui_str': 'Ayurvedic medicine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0042965', 'cui_str': 'Vomitus'}, {'cui': 'C0233496', 'cui_str': 'Aversion'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0549448', 'cui_str': 'Increased hemoglobin'}]",30.0,0.0580381,"The drug showed statistically significant effect in reducing the frequency of vomiting per day, quantity of vomitus, aversion to smell, nausea and anorexia, altered content of vomitus, improved appetite, imparted lightness of body and increased haemoglobin gm%.
","[{'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Department of Prasuti Tantra and Stree Roga, SCPM Ayurvedic Medical College and Hospital, Gonda, 271003, U.P., India. Electronic address: deepika.sbri@gmail.com.'}, {'ForeName': 'Vasudevan', 'Initials': 'V', 'LastName': 'Asokan', 'Affiliation': 'Department of Prasuti Tantra and Stree Roga, Parul Institute of Ayurveda, Limda, Waghodia, Vadodara, 391760, Gujarat, India.'}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Bhat Nv', 'Affiliation': 'Department of Prasuti Tantra and Stree Roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, 573201, Karnataka, India.'}, {'ForeName': 'Prathima', 'Initials': 'P', 'LastName': 'Jain', 'Affiliation': 'Department of Prasuti Tantra and Stree Roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, 573201, Karnataka, India.'}, {'ForeName': 'Kavyashree', 'Initials': 'K', 'LastName': 'Hl', 'Affiliation': 'Government Ayurveda Hospital, Mudigere, Chikmagalur, 577132, Karnataka, India.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2021.08.015']
1834,35105722,"Low-dose belimumab for patients with systemic lupus erythematosus at low disease activity: protocol for a multicentre, randomised, double-blind, placebo-controlled clinical trial.","INTRODUCTION


SLE is a chronic inflammatory systemic autoimmune disease with relapsing-remitting pattern. B-lymphocyte stimulator was involved in the pathogenesis of SLE. The humanised monoclonal antibody belimumab with 10 mg/kg was effective for active patients. However, the efficacy of low-dose belimumab for prevention of disease flares in patients with SLE with low disease activity is to be explored.
METHODS AND ANALYSIS


This is a multicentre, randomised, double-blind, placebo-controlled clinical trial. Patients who have Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) scores no higher than 6; with no A score or no more than one B score on the British Isles Lupus Assessment Group (BILAG) scale; and who are treated with prednisone (≤20 mg per day) at screening will be enrolled. 334 adults will be randomly assigned in a 1:1 ratio to receive intravenous 120 mg belimumab or placebo (saline) arm on weeks 0, 2, and 4, and then every 4 weeks until 48 weeks, with standard of care. The primary outcome measure is a composite index of severe or mild-to-moderate disease flares (SELENA-SLEDAI Flare Index) within 52 weeks. Secondary outcomes include the percentage of severe flare, the percentage of mild-to-moderate flare, time to first disease flare, changes in prednisone dose, SELENA-SLEDAI, as well as BILAG score, the percentage of patients achieving prednisone free and safety analysis.
ETHICS AND DISSEMINATION


The protocol has been approved by the Ethics Committee of the Renji Hospital, Huashan Hospital and the Sixth People's Hospital. The trial has been registered and the detailed information is available at https://clinicaltrialsgov/ct2/show/NCT04515719. The results of this clinical trial will be submitted for publication in peer-reviewed journals and key findings will also be presented at national and international conferences.
TRIAL REGISTRATION NUMBER


NCT04515719.",2022,The humanised monoclonal antibody belimumab with 10 mg/kg was effective for active patients.,"['patients with SLE with low disease activity', 'patients with systemic lupus erythematosus at low disease activity', '334 adults']","['placebo', 'intravenous 120\u2009mg belimumab or placebo (saline', 'Low-dose belimumab', 'prednisone']","['composite index of severe or mild-to-moderate disease flares (SELENA-SLEDAI Flare Index', 'percentage of severe flare, the percentage of mild-to-moderate flare, time to first disease flare, changes in prednisone dose, SELENA-SLEDAI, as well as BILAG score, the percentage of patients achieving prednisone free and safety analysis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0020750', 'cui_str': 'Iceland'}, {'cui': 'C0024131', 'cui_str': 'Lupus vulgaris'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",334.0,0.706715,The humanised monoclonal antibody belimumab with 10 mg/kg was effective for active patients.,"[{'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Liling', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Danting', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Wan', 'Affiliation': 'Department of Rheumatology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Sheng-Ming', 'Initials': 'SM', 'LastName': 'Dai', 'Affiliation': ""Department of Rheumatology and Immunology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China ye_shuang2000@163.com.'}]",Lupus science & medicine,['10.1136/lupus-2021-000638']
1835,35106880,"Repeated low doses of LSD in healthy adults: A placebo-controlled, dose-response study.","The resurgence of interest in using psychedelic drugs, including lysergic acid diethylamide (LSD), in psychiatry has drawn attention to the medically unsupervised practice of 'microdosing'. Thousands of users claim that very low doses of LSD, taken at 3-4-day intervals, improve mood and cognitive function., However, few controlled studies have described the effects of the drug when taken in this way. Here, in a double-blind controlled study, we studied the effects of four repeated doses of LSD tartrate (13 or 26 μg) or placebo, administered to healthy adults at 3-4 day intervals, on mood, cognitive performance and responses to emotional tasks. Participants were randomly assigned to one of three drug conditions: placebo (N = 18), 13 μg LSD (N = 19), or 26 μg LSD (N = 19). They attended four 5-hour drug-administration sessions separated by 3-4 days, followed by a drug-free follow-up session 3-4 days after the last session. LSD (26 μg) produced modest subjective effects including increased ratings of 'feeling a drug effect' and both stimulant-like and LSD-like effects, but the drug did not improve mood or affect performance on psychomotor or most emotional tasks. No residual effects were detected on mood or task performance on the drug-free follow-up session. We conclude that within the context of a controlled setting and a limited number of administrations, repeated low doses of LSD are safe, but produce negligible changes in mood or cognition in healthy volunteers.",2022,"LSD (26 μg) produced modest subjective effects including increased ratings of 'feeling a drug effect' and both stimulant-like and LSD-like effects, but the drug did not improve mood or affect performance on psychomotor or most emotional tasks.","['healthy adults', 'healthy volunteers']","['placebo', 'LSD tartrate', 'LSD']","[""ratings of 'feeling a drug effect' and both stimulant-like and LSD-like effects"", 'mood or task performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024335', 'cui_str': 'Lysergic Acid Diethylamide Tartrate'}, {'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",,0.101098,"LSD (26 μg) produced modest subjective effects including increased ratings of 'feeling a drug effect' and both stimulant-like and LSD-like effects, but the drug did not improve mood or affect performance on psychomotor or most emotional tasks.","[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Hanna M', 'Initials': 'HM', 'LastName': 'Molla', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Anya', 'Initials': 'A', 'LastName': 'Bershad', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California at Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bremmer', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Royce', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois, USA.'}]",Addiction biology,['10.1111/adb.13143']
1836,35098531,Acetylcysteine has No Mechanistic Effect in Patients at Risk of Contrast-Induced Nephropathy: A Failure of Academic Clinical Science.,"Contrast-induced nephropathy (CIN) is a major complication of imaging in patients with chronic kidney disease (CKD). The publication of an academic randomized controlled trial (RCT; n = 83) reporting oral (N)-acetylcysteine (NAC) to reduce CIN led to > 70 clinical trials, 23 systematic reviews, and 2 large RCTs showing no benefit. However, no mechanistic studies were conducted to determine how NAC might work; proposed mechanisms included renal artery vasodilatation and antioxidant boosting. We evaluated the proposed mechanisms of NAC action in participants with healthy and diseased kidneys. Four substudies were performed. Two randomized, double-blind, placebo-controlled, three-period crossover studies (n = 8) assessed the effect of oral and intravenous (i.v.) NAC in healthy kidneys in the presence/absence of iso-osmolar contrast (iodixanol). A third crossover study in patients with CKD stage III (CKD3) (n = 8) assessed the effect of oral and i.v. NAC without contrast. A three-arm randomized, double-blind, placebo-controlled parallel-group study, recruiting patients with CKD3 (n = 66) undergoing coronary angiography, assessed the effect of oral and i.v. NAC in the presence of contrast. We recorded systemic (blood pressure and heart rate) and renal (renal blood flow (RBF) and glomerular filtration rate (GFR)) hemodynamics, and antioxidant status, plus biomarkers of renal injury in patients with CKD3 undergoing angiography. Primary outcome for all studies was RBF over 8 hours after the start of i.v. NAC/placebo. NAC at doses used in previous trials of renal prophylaxis was essentially undetectable in plasma after oral administration. In healthy volunteers, i.v. NAC, but not oral NAC, increased blood pressure (mean area under the curve (AUC) mean arterial pressure (MAP): mean difference 29 h⋅mmHg, P = 0.019 vs. placebo), heart rate (28 h⋅bpm, P < 0.001), and RBF (714 h⋅mL/min, 8.0% increase, P = 0.006). Renal vasodilatation also occurred in the presence of contrast (RBF 917 h⋅mL/min, 12% increase, P = 0.005). In patients with CKD3 without contrast, only a rise in heart rate (34 h⋅bpm, P = 0.010) and RBF (288 h⋅mL/min, 6.0% increase, P = 0.001) occurred with i.v. NAC, with no significant effect on blood pressure (MAP rise 26 h⋅mmHg, P = 0.156). Oral NAC showed no effect. In patients with CKD3 receiving contrast, i.v. NAC increased blood pressure (MAP rise 52 h⋅mmHg, P = 0.008) but had no effect on RBF (151 h⋅mL/min, 3.0% increase, P = 0.470), GFR (29 h⋅mL/min/1.73m², P = 0.122), or markers of renal injury. Neither i.v. nor oral NAC affected plasma antioxidant status. We found oral NAC to be poorly absorbed and have no reno-protective effects. Intravenous, not oral, NAC caused renal artery vasodilatation in healthy volunteers but offered no protection to patients with CKD3 at risk of CIN. These findings emphasize the importance of mechanistic clinical studies before progressing to RCTs for novel interventions. Thousands were recruited to academic clinical trials without the necessary mechanistic studies being performed to confirm the approach had any chance of working.",2022,"In CKD3 patients receiving contrast, IV NAC increased blood pressure (MAP rise 52 h.mmHg, p=0.008) but had no effect on RBF (151 h.mL/min, 3.0% increase, p=0.470), GFR (29h.mL/min/1.73m², p=0.122), or markers of renal injury.","['participants with healthy and diseased kidneys', 'patients (n=66) undergoing', 'healthy volunteers', 'CKD3 patients undergoing angiography', 'healthy kidneys in the presence/absence of iso-osmolar contrast (iodixanol', 'patients with chronic kidney disease (CKD']","['placebo', 'NAC', 'Acetylcysteine', 'CKD3', 'academic RCT (n=83) reporting oral (N)-acetylcysteine (NAC', 'coronary-angiography', 'Contrast-induced nephropathy (CIN', 'oral and intravenous (IV) NAC']","['Renal vasodilatation', 'blood pressure', 'plasma antioxidant status', 'renal artery vasodilatation', 'systemic (blood pressure, heart-rate) and renal (renal blood flow [RBF], glomerular filtration rate [GFR]) haemodynamics, and antioxidant status, plus biomarkers of renal injury', 'RBF', 'heart-rate']","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0439351', 'cui_str': 'osmol/L'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0063757', 'cui_str': 'iodixanol'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035065', 'cui_str': 'Structure of renal artery'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035070', 'cui_str': 'Circulation, Renal'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}]",66.0,0.0759578,"In CKD3 patients receiving contrast, IV NAC increased blood pressure (MAP rise 52 h.mmHg, p=0.008) but had no effect on RBF (151 h.mL/min, 3.0% increase, p=0.470), GFR (29h.mL/min/1.73m², p=0.122), or markers of renal injury.","[{'ForeName': 'Euan A', 'Initials': 'EA', 'LastName': 'Sandilands', 'Affiliation': 'Pharmacology, Toxicology, and Therapeutics, University/BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jessica M B', 'Initials': 'JMB', 'LastName': 'Rees', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Khuram', 'Initials': 'K', 'LastName': 'Raja', 'Affiliation': 'Free Radical Research Facility, University of the Highlands & Islands, Inverness, UK.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Dhaun', 'Affiliation': 'Pharmacology, Toxicology, and Therapeutics, University/BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Emma E', 'Initials': 'EE', 'LastName': 'Morrison', 'Affiliation': 'Pharmacology, Toxicology, and Therapeutics, University/BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Hickson', 'Affiliation': 'Free Radical Research Facility, University of the Highlands & Islands, Inverness, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wraight', 'Affiliation': 'Pharmacology, Toxicology, and Therapeutics, University/BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Gray', 'Affiliation': 'Pharmacology, Toxicology, and Therapeutics, University/BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Briody', 'Affiliation': 'Wellcome Trust Clinical Research Facility, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Cameron', 'Affiliation': 'Wellcome Trust Clinical Research Facility, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Adrian P', 'Initials': 'AP', 'LastName': 'Thompson', 'Affiliation': 'Pharmacology, Toxicology, and Therapeutics, University/BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Johnston', 'Affiliation': 'Pharmacology, Toxicology, and Therapeutics, University/BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Uren', 'Affiliation': 'Department of Cardiology, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Goddard', 'Affiliation': 'Department of Renal Medicine, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Treweeke', 'Affiliation': 'Free Radical Research Facility, University of the Highlands & Islands, Inverness, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Rushworth', 'Affiliation': 'Free Radical Research Facility, University of the Highlands & Islands, Inverness, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Webb', 'Affiliation': 'Pharmacology, Toxicology, and Therapeutics, University/BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'D Nicholas', 'Initials': 'DN', 'LastName': 'Bateman', 'Affiliation': 'Pharmacology, Toxicology, and Therapeutics, University/BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ian L', 'Initials': 'IL', 'LastName': 'Megson', 'Affiliation': 'Free Radical Research Facility, University of the Highlands & Islands, Inverness, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eddleston', 'Affiliation': 'Pharmacology, Toxicology, and Therapeutics, University/BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2541']
1837,35093205,"Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial.","BACKGROUND


Passive immunotherapy using hyperimmune intravenous immunoglobulin (hIVIG) to SARS-CoV-2, derived from recovered donors, is a potential rapidly available, specific therapy for an outbreak infection such as SARS-CoV-2. Findings from randomised clinical trials of hIVIG for the treatment of COVID-19 are limited.
METHODS


In this international randomised, double-blind, placebo-controlled trial, hospitalised patients with COVID-19 who had been symptomatic for up to 12 days and did not have acute end-organ failure were randomly assigned (1:1) to receive either hIVIG or an equivalent volume of saline as placebo, in addition to remdesivir, when not contraindicated, and other standard clinical care. Randomisation was stratified by site pharmacy; schedules were prepared using a mass-weighted urn design. Infusions were prepared and masked by trial pharmacists; all other investigators, research staff, and trial participants were masked to group allocation. Follow-up was for 28 days. The primary outcome was measured at day 7 by a seven-category ordinal endpoint that considered pulmonary status and extrapulmonary complications and ranged from no limiting symptoms to death. Deaths and adverse events, including organ failure and serious infections, were used to define composite safety outcomes at days 7 and 28. Prespecified subgroup analyses were carried out for efficacy and safety outcomes by duration of symptoms, the presence of anti-spike neutralising antibodies, and other baseline factors. Analyses were done on a modified intention-to-treat (mITT) population, which included all randomly assigned participants who met eligibility criteria and received all or part of the assigned study product infusion. This study is registered with ClinicalTrials.gov, NCT04546581.
FINDINGS


From Oct 8, 2020, to Feb 10, 2021, 593 participants (n=301 hIVIG, n=292 placebo) were enrolled at 63 sites in 11 countries; 579 patients were included in the mITT analysis. Compared with placebo, the hIVIG group did not have significantly greater odds of a more favourable outcome at day 7; the adjusted OR was 1·06 (95% CI 0·77-1·45; p=0·72). Infusions were well tolerated, although infusion reactions were more common in the hIVIG group (18·6% vs 9·5% for placebo; p=0·002). The percentage with the composite safety outcome at day 7 was similar for the hIVIG (24%) and placebo groups (25%; OR 0·98, 95% CI 0·66-1·46; p=0·91). The ORs for the day 7 ordinal outcome did not vary for subgroups considered, but there was evidence of heterogeneity of the treatment effect for the day 7 composite safety outcome: risk was greater for hIVIG compared with placebo for patients who were antibody positive (OR 2·21, 95% CI 1·14-4·29); for patients who were antibody negative, the OR was 0·51 (0·29-0·90; p interaction =0·001).
INTERPRETATION


When administered with standard of care including remdesivir, SARS-CoV-2 hIVIG did not demonstrate efficacy among patients hospitalised with COVID-19 without end-organ failure. The safety of hIVIG might vary by the presence of endogenous neutralising antibodies at entry.
FUNDING


US National Institutes of Health.",2022,"Compared with placebo, the hIVIG group did not have significantly greater odds of a more favourable outcome at day 7; the adjusted OR was 1·06 (95% CI 0·77-1·45; p=0·72).","['hospitalised patients with COVID-19 (ITAC', 'patients hospitalised with COVID-19 without end-organ failure', '593 participants (n=301 hIVIG, n=292 placebo) were enrolled at 63 sites in 11 countries; 579 patients were included in the mITT analysis', 'hospitalised patients with COVID-19 who had been symptomatic for up to 12 days and did not have acute end-organ failure']","['placebo', 'hIVIG or an equivalent volume of saline as placebo', 'Hyperimmune immunoglobulin']","['composite safety outcome', 'tolerated', 'pulmonary status and extrapulmonary complications and ranged from no limiting symptoms to death', 'efficacy and safety outcomes by duration of symptoms, the presence of anti-spike neutralising antibodies, and other baseline factors', 'Deaths and adverse events, including organ failure and serious infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",579.0,0.925944,"Compared with placebo, the hIVIG group did not have significantly greater odds of a more favourable outcome at day 7; the adjusted OR was 1·06 (95% CI 0·77-1·45; p=0·72).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(22)00101-5']
1838,35065334,Asymmetric effects of acute stress on cost and benefit learning.,"BACKGROUND


Humans are continuously exposed to stressful challenges in everyday life. Such stressful events trigger a complex physiological reaction - the fight-or-flight response - that can hamper flexible decision-making and learning. Inspired by key neural and peripheral characteristics of the fight-or-flight response, here, we ask whether acute stress changes how humans learn about costs and benefits.
METHODS


Healthy adults were randomly exposed to an acute stress (age mean=23.48, 21/40 female) or no-stress control (age mean=23.80, 22/40 female) condition, after which they completed a reinforcement learning task in which they minimize cost (physical effort) and maximize benefits (monetary rewards). During the task pupillometry data were collected. A computational model of cost-benefit reinforcement learning was employed to investigate the effect of acute stress on cost and benefit learning and decision-making.
RESULTS


Acute stress improved learning to maximize rewards relative to minimizing physical effort (Condition-by-Trial Type interaction: F(1,78)= 6.53, p = 0.01, n 2 G = 0.04; reward > effort in stress condition: t(39) = 5.40, p < 0.01). Computational modelling revealed that asymmetric learning could be explained by changes in the learning rates of reward value and action cost [condition-by-learning rate (αR, αE) interaction: F(1,78)= 6.42, p = 0.01, n 2 G = 0.03; αE> αR in control condition: t(39) = -4.75, p < 0.001]. This process was associated with distinct alterations in pupil size fluctuations. Data and scripts are available (https://osf.io/ydv2q/).
CONCLUSIONS


Here we demonstrate that acute stress is associated with asymmetric learning about reward value versus action cost, thereby providing new insights into learning strategies under acute stress, which, depending on the context, may be maladaptive or beneficial. Our pupillometry and physiological results tentatively link asymmetric cost and benefit learning to stress-related changes in catecholamine activity.",2022,"F(1,78)= 6.53, p = 0.01, n 2 G = 0.04; reward > effort in stress condition: t(39) = 5.40, p < 0.01).","['Healthy adults were randomly exposed to an acute stress (age mean=23.48, 21/40 female) or no-stress control (age mean=23.80, 22/40 female) condition, after which they completed a']",['reinforcement learning task'],"['cost and benefit learning', 'learning rates of reward value and action cost [condition-by-learning rate']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0010187', 'cui_str': 'Benefits and Costs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0482667,"F(1,78)= 6.53, p = 0.01, n 2 G = 0.04; reward > effort in stress condition: t(39) = 5.40, p < 0.01).","[{'ForeName': 'Stella D', 'Initials': 'SD', 'LastName': 'Voulgaropoulou', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Minderbroedersberg 4-6, 6211 LK Maastricht, The Netherlands. Electronic address: s.voulgaropoulou@maastrichtuniversity.nl.'}, {'ForeName': 'Fasya', 'Initials': 'F', 'LastName': 'Fauzani', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Minderbroedersberg 4-6, 6211 LK Maastricht, The Netherlands.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Pfirrmann', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Minderbroedersberg 4-6, 6211 LK Maastricht, The Netherlands.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Vingerhoets', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Minderbroedersberg 4-6, 6211 LK Maastricht, The Netherlands; Department of Radiology & Nuclear Medicine, Amsterdam University Medical Centre, Location AMC, Meibergdreef 5, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Thérèse', 'Initials': 'T', 'LastName': 'van Amelsvoort', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Minderbroedersberg 4-6, 6211 LK Maastricht, The Netherlands.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Hernaus', 'Affiliation': 'Department of Psychiatry & Neuropsychology, Maastricht University, Minderbroedersberg 4-6, 6211 LK Maastricht, The Netherlands. Electronic address: dennis.hernaus@maastrichtuniversity.nl.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2021.105646']
1839,35089205,The anti-infective outcomes of the distal femoral replacement coated with antibiotic cement in limb salvage surgery: A randomized clinical trial.,"BACKGROUND


The aim of this study was to observe the anti-infective effect of the distal femoral tumor prosthesis coated with antibiotic cement during limb salvage treatment, and evaluate its potential prospect in clinic.
METHODS


In this randomized controlled trial, the en bloc resection and reconstruction were performed in 36 patients with distal femoral primary bone tumor. Patients were divided into 2 groups randomly according to the application of antibiotic bone cement coating, which included antibiotic cement coating group (16 cases) and control group (18 cases). There were 10 men and 6 women in anti-infection group, aged from 18 to 54 years (23.47 ± 3.53), and there were 12 men and 6 women in control group, aged from 19 to 56 years (24.16 ± 4.32). The tumor type, age, sex, and Enneking stage were enrolled with well-matched of the 2 groups of patients. There was no difference between bundles and routine standard care for each group. The antibiotic cement was coated on the surface of polyethylene jacket with punched holes during operation. The peri-prosthetic infection, local recurrence and distant metastasis were followed up and limb functions were evaluated by Musculoskeletal Tumor Society 93 (MSTS93) scoring system.
RESULTS


Patients were followed up till 34.7 months (range 18∼62 months). There was no periprosthetic infection in anti-infection group. Four cases in control group showed deep infection. Infection rate had significant differences between the 2 groups (P < .05). Infection-related prosthesis mortality was 0% (0/16) in anti-infection group and 16.67% (3/18) in control group. Local recurrence and distant metastasis occurred in 7 of 34 patients with primary malignant bone tumor, wherein 2 cases of local recurrence and 1 cases of distant metastasis occurred in anti-infective group; 2 cases of local recurrence and 2 cases of distant metastasis occurred in the control group. During a latest follow-up, MSTS93 function scoring revealed a mean of 25.6 ± 4.2 in anti-infection group and 18.5 ± 3.3 in control group. The survival rate of anti-infective group is 75%, and the survival rate of control group is 61.11%.
CONCLUSION


The antibiotic cement-coated technique on the surface of the polyethylene jacket of custom-made distal femoral prosthesis is simple and effective in controlling the periprosthetic infection after tumor prosthesis reconstruction.",2022,"Local recurrence and distant metastasis occurred in 7 of 34 patients with primary malignant bone tumor, wherein 2 cases of local recurrence and 1 cases of distant metastasis occurred in anti-infective group; 2 cases of local recurrence and 2 cases of distant metastasis occurred in the control group.","['limb salvage surgery', '10 men and 6 women in anti-infection group, aged from 18 to 54 years (23.47\u200a±\u200a3.53), and there were 12 men and 6 women in control group, aged from 19 to 56 years (24.16\u200a±\u200a4.32', '36 patients with distal femoral primary bone tumor']","['antibiotic bone cement coating, which included antibiotic cement coating', 'distal femoral tumor prosthesis coated with antibiotic cement', 'distal femoral replacement coated with antibiotic cement']","['deep infection', 'Local recurrence and distant metastasis', 'Infection rate', 'periprosthetic infection', 'distant metastasis', 'survival rate', 'local recurrence', 'Infection-related prosthesis mortality', 'peri-prosthetic infection, local recurrence and distant metastasis']","[{'cui': 'C0949591', 'cui_str': 'Limb Salvage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517760', 'cui_str': '4.32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0005967', 'cui_str': 'Neoplasm of bone'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0005934', 'cui_str': 'Bone cements'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0349726', 'cui_str': 'Prosthetic infection'}]",36.0,0.0701022,"Local recurrence and distant metastasis occurred in 7 of 34 patients with primary malignant bone tumor, wherein 2 cases of local recurrence and 1 cases of distant metastasis occurred in anti-infective group; 2 cases of local recurrence and 2 cases of distant metastasis occurred in the control group.","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': ""Orthopedic Oncology Department, Xijing Hospital, the Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': ""Orthopedic Oncology Department, Xijing Hospital, the Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Tao', 'Affiliation': 'Department of Spine Surgery, Wuhan No. 1 Hospital, Wuhan, Hubei, P.R. China.'}, {'ForeName': 'Xiaokang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Orthopedics, Tangdu Hospital, the Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': ""Department of Orthopedics, Tangdu Hospital, the Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xinghui', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': ""Orthopedic Oncology Department, Xijing Hospital, the Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xiaodi', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Orthopedic Oncology Department, Xijing Hospital, the Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Orthopedics, Tangdu Hospital, the Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': ""Department of Orthopedics, Tangdu Hospital, the Fourth Military Medical University, Xi'an, China.""}]",Medicine,['10.1097/MD.0000000000028648']
1840,35102782,Clinical effects of glabellar botulinum toxin injections on borderline personality disorder: A randomized controlled trial.,"BACKGROUND


Inhibition of frowning via injections of botulinum toxin A (BTX) into the glabellar region has shown beneficial effects in the treatment of major depression. Preliminary research suggests that improvements in the affective domain are not depression-specific, but may also translate to other psychiatric disorders.
AIM


This 16-week, single-blind, two-center randomized controlled trial investigated the influence of BTX on clinical symptoms of borderline personality disorder (BPD).
METHODS


Fifty-four patients with BPD were randomly assigned to treatment with BTX  (n  = 27) or a minimal acupuncture (ACU) control condition ( n  = 27). Clinical outcomes were followed at 2, 4, 6, 8, 12, and 16 weeks. Primary endpoint was the relative score change on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) 8 weeks after baseline relative to the control group and adjusted for treatment center. Secondary and additional outcome variables were self-rated borderline symptoms, comorbid symptoms of depression, psychological distress, and clinical global impression.
RESULTS


Participants showed significant improvements at the primary efficacy endpoint in both treatment groups (BTX:  M  = -0.39,  SD  = 0.39; ACU:  M  = -0.35,  SD  = 0.42), but no superior effect of the BTX condition in comparison with the control intervention was found- F (1,5323) = 0.017,  p  = 0.68). None of the secondary or additional outcomes yielded significant group differences. Side effects were mild and included headache, transient skin or muscle irritations, and dizziness.
CONCLUSION


Evidence regarding the efficacy of BTX for BDP remains limited, and the design of adequate control conditions presents an opportunity for further research. ClinicalTrials.gov registry : Botulinum Toxin A for Emotional Stabilization in Borderline Personality Disorder (BPD), NCT02728778, https://clinicaltrials.gov/ct2/show/NCT02728778.",2022,None of the secondary or additional outcomes yielded significant group differences.,"['borderline personality disorder (BPD', 'borderline personality disorder', 'Fifty-four patients with BPD']","['BTX  (n \u2009=\u200927) or a minimal acupuncture (ACU) control condition', 'botulinum toxin A (BTX', 'BTX', 'glabellar botulinum toxin injections']","['relative score change on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD', 'self-rated borderline symptoms, comorbid symptoms of depression, psychological distress, and clinical global impression', 'headache, transient skin or muscle irritations, and dizziness']","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",54.0,0.317812,None of the secondary or additional outcomes yielded significant group differences.,"[{'ForeName': 'M Axel', 'Initials': 'MA', 'LastName': 'Wollmer', 'Affiliation': 'Asklepios Clinic North - Ochsenzoll, Asklepios Campus Hamburg, Medical Faculty, Semmelweis University, Germany.'}, {'ForeName': 'Insa', 'Initials': 'I', 'LastName': 'Neumann', 'Affiliation': 'Asklepios Clinic North - Ochsenzoll, Asklepios Campus Hamburg, Medical Faculty, Semmelweis University, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Division of Clinical Psychology and Sexual Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Bechinie', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Division of Clinical Psychology and Sexual Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Herrmann', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Division of Clinical Psychology and Sexual Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Asklepios Clinic North - Ochsenzoll, Asklepios Campus Hamburg, Medical Faculty, Semmelweis University, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wohlmuth', 'Affiliation': 'Asklepios Proresearch, Hamburg, Germany.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Fournier-Kaiser', 'Affiliation': 'Asklepios Clinic North - Ochsenzoll, Asklepios Campus Hamburg, Medical Faculty, Semmelweis University, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sperling', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Division of Clinical Psychology and Sexual Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Peters', 'Affiliation': 'Asklepios Clinic North - Ochsenzoll, Asklepios Campus Hamburg, Medical Faculty, Semmelweis University, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Kneer', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Division of Clinical Psychology and Sexual Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Jannis', 'Initials': 'J', 'LastName': 'Engel', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Division of Clinical Psychology and Sexual Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Jürgensen', 'Affiliation': 'Asklepios Clinic North - Ochsenzoll, Asklepios Campus Hamburg, Medical Faculty, Semmelweis University, Germany.'}, {'ForeName': 'Jara', 'Initials': 'J', 'LastName': 'Schulze', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Division of Clinical Psychology and Sexual Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Nagel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Asklepios Clinic North - Wandsbek, Hamburg, Germany.'}, {'ForeName': 'Welf', 'Initials': 'W', 'LastName': 'Prager', 'Affiliation': 'Dermatologische Praxis, Prager & Partner, Hamburg, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sinke', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Division of Clinical Psychology and Sexual Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Kai G', 'Initials': 'KG', 'LastName': 'Kahl', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Karst', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Pain Clinic, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Birger', 'Initials': 'B', 'LastName': 'Dulz', 'Affiliation': 'Asklepios Clinic North - Ochsenzoll, Asklepios Campus Hamburg, Medical Faculty, Semmelweis University, Germany.'}, {'ForeName': 'Tillmann H C', 'Initials': 'THC', 'LastName': 'Kruger', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Division of Clinical Psychology and Sexual Medicine, Hannover Medical School, Hannover, Germany.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/02698811211069108']
1841,35106618,"The influence of bright and dim light on substrate metabolism, energy expenditure and thermoregulation in insulin-resistant individuals depends on time of day.","AIMS/HYPOTHESIS


In our modern society, artificial light is available around the clock and most people expose themselves to electrical light and light-emissive screens during the dark period of the natural light/dark cycle. Such suboptimal lighting conditions have been associated with adverse metabolic effects, and redesigning indoor lighting conditions to mimic the natural light/dark cycle more closely holds promise to improve metabolic health. Our objective was to compare metabolic responses to lighting conditions that resemble the natural light/dark cycle in contrast to suboptimal lighting in individuals at risk of developing metabolic diseases.
METHODS


Therefore, we here performed a non-blinded, randomised, controlled, crossover trial in which overweight insulin-resistant volunteers (n = 14) were exposed to two 40 h laboratory sessions with different 24 h lighting protocols while staying in a metabolic chamber under real-life conditions. In the Bright day-Dim evening condition, volunteers were exposed to electric bright light (~1250 lx) during the daytime (08:00-18:00 h) and to dim light (~5 lx) during the evening (18:00-23:00 h). Vice versa, in the Dim day-Bright evening condition, volunteers were exposed to dim light during the daytime and bright light during the evening. Randomisation and allocation to light conditions were carried out by sequential numbering. During both lighting protocols, we performed 24 h indirect calorimetry, and continuous core body and skin temperature measurements, and took frequent blood samples. The primary outcome was plasma glucose focusing on the pre- and postprandial periods of the intervention.
RESULTS


Spending the day in bright light resulted in a greater increase in postprandial triacylglycerol levels following breakfast, but lower glucose levels preceding the dinner meal at 18:00 h, compared with dim light (5.0 ± 0.2 vs 5.2 ± 0.2 mmol/l, n = 13, p=0.02). Dim day-Bright evening reduced the increase in postprandial glucose after dinner compared with Bright day-Dim evening (incremental AUC: 307 ± 55 vs 394 ± 66 mmol/l × min, n = 13, p=0.009). After the Bright day-Dim evening condition the sleeping metabolic rate was identical compared with the baseline night, whereas it dropped after Dim day-Bright evening. Melatonin secretion in the evening was strongly suppressed for Dim day-Bright evening but not for Bright day-Dim evening. Distal skin temperature for Bright day-Dim evening was lower at 18:00 h (28.8 ± 0.3°C vs 29.9 ± 0.4°C, n = 13, p=0.039) and higher at 23:00 h compared with Dim day-Bright evening (30.1 ± 0.3°C vs 28.8 ± 0.3°C, n = 13, p=0.006). Fasting and postprandial plasma insulin levels and the respiratory exchange ratio were not different between the two lighting protocols at any time.
CONCLUSIONS/INTERPRETATION


Together, these findings suggest that the indoor light environment modulates postprandial substrate handling, energy expenditure and thermoregulation of insulin-resistant volunteers in a time-of-day-dependent manner.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03829982.
FUNDING


We acknowledge the financial support from the Netherlands Cardiovascular Research Initiative: an initiative with support from the Dutch Heart Foundation (CVON2014-02 ENERGISE).",2022,"Spending the day in bright light resulted in a greater increase in postprandial triacylglycerol levels following breakfast, but lower glucose levels preceding the dinner meal at 18:00 h, compared with dim light (5.0 ± 0.2 vs 5.2 ± 0.2 mmol/l, n = 13, p=0.02).",['overweight insulin-resistant volunteers (n\u2009=\u200914'],"['electric bright light', 'bright and dim light']","['Fasting and postprandial plasma insulin levels and the respiratory exchange ratio', 'sleeping metabolic rate', 'plasma glucose focusing on the pre- and postprandial periods of the intervention', 'postprandial triacylglycerol levels', 'postprandial glucose', 'Melatonin secretion', 'Distal skin temperature']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1276042', 'cui_str': 'Plasma insulin measurement'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}]",,0.0572859,"Spending the day in bright light resulted in a greater increase in postprandial triacylglycerol levels following breakfast, but lower glucose levels preceding the dinner meal at 18:00 h, compared with dim light (5.0 ± 0.2 vs 5.2 ± 0.2 mmol/l, n = 13, p=0.02).","[{'ForeName': 'Jan-Frieder', 'Initials': 'JF', 'LastName': 'Harmsen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Wefers', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Doligkeit', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Schlangen', 'Affiliation': 'Human-Technology Interaction Group and Intelligent Lighting Institute, Department of Industrial Engineering and Innovation Sciences, Eindhoven University of Technology, Eindhoven, the Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Dautzenberg', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Rense', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'van Moorsel', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Hoeks', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Moonen-Kornips', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Marijke C M', 'Initials': 'MCM', 'LastName': 'Gordijn', 'Affiliation': 'Chronobiology Unit, Groningen Institute for Evolutionary Life Sciences, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Wouter D', 'Initials': 'WD', 'LastName': 'van Marken Lichtenbelt', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, the Netherlands. p.schrauwen@maastrichtuniversity.nl.'}]",Diabetologia,['10.1007/s00125-021-05643-9']
1842,35101523,mTORC1 inhibitor effects on rapid ketamine-induced reductions in suicidal ideation in patients with treatment-resistant depression.,"Suicide is a public health crisis with limited treatment options. Ketamine has demonstrated rapid and robust improvements in suicidal ideation (SI). The parent study for the secondary pilot analyses presented here was a double-blind, cross-over trial that found pretreatment with the mechanistic target of rapamycin complex 1 (mTORC1) prolonged the antidepressant effects of ketamine. Here we examined the effect of mTORC1 inhibition on ketamine's antisuicidal effects. Twenty patients in a major depressive episode were randomized to pretreatment with oral rapamycin (6 mg) or placebo prior to IV ketamine (0.5 mg/kg). We found ketamine administration resulted in significant improvements across all measures with the largest effect at 24 h with only the Beck Scale for Suicide remaining significant at the two-week follow-up. There were no significant main effects of pretreatment. While these analyses are pilot in nature and overall severity of SI was relatively low, the antisuicidal findings (no effect of rapamycin) being in contrast to the antidepressant effects (prolonged effect with rapamycin), suggest the rapid-acting antisuicidal and antidepressant effects of ketamine may be mechanistically distinct and the trajectories of response, recovery, and relapse may be independent. These findings provide additional evidence of ketamine's antisuicidal effects and highlight the importance of future studies that continue to examine potential differences in mechanisms and trajectory of outcomes.",2022,We found ketamine administration resulted in significant improvements across all measures with the largest effect at 24 hrs with only the Beck Scale for Suicide remaining significant at the two-week follow-up.,"['patients with treatment-resistant depression', 'Twenty patients in a major depressive episode']","['placebo prior to IV ketamine', 'Ketamine', 'oral rapamycin', 'ketamine', 'rapamycin']","['suicidal ideation', 'suicidal ideation (SI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",,0.0685079,We found ketamine administration resulted in significant improvements across all measures with the largest effect at 24 hrs with only the Beck Scale for Suicide remaining significant at the two-week follow-up.,"[{'ForeName': 'Lynnette A', 'Initials': 'LA', 'LastName': 'Averill', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA; Menninger Department of Psychiatry, Baylor College of Medicine, Houston, TX, USA; US Department of Veterans Affairs, National Center for PTSD - Clinical Neuroscience Division, West Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. Electronic address: lynnette.averill@bcm.edu.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Averill', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA; Menninger Department of Psychiatry, Baylor College of Medicine, Houston, TX, USA; US Department of Veterans Affairs, National Center for PTSD - Clinical Neuroscience Division, West Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Fouda', 'Affiliation': 'US Department of Veterans Affairs, National Center for PTSD - Clinical Neuroscience Division, West Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sherif', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA; Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Carney Institute for Brain Science, Brown University, Providence, RI, USA.'}, {'ForeName': 'Kyung-Heup', 'Initials': 'KH', 'LastName': 'Ahn', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Deepak Cyril', 'Initials': 'DC', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Southwick', 'Affiliation': 'US Department of Veterans Affairs, National Center for PTSD - Clinical Neuroscience Division, West Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Duman', 'Affiliation': 'US Department of Veterans Affairs, National Center for PTSD - Clinical Neuroscience Division, West Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'US Department of Veterans Affairs, National Center for PTSD - Clinical Neuroscience Division, West Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Chadi G', 'Initials': 'CG', 'LastName': 'Abdallah', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA; Menninger Department of Psychiatry, Baylor College of Medicine, Houston, TX, USA; US Department of Veterans Affairs, National Center for PTSD - Clinical Neuroscience Division, West Haven, CT, USA; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2022.01.104']
1843,35101472,Are music listening strategies associated with reduced food consumption following negative mood inductions; a series of three exploratory experimental studies.,"Emotions play an important role in overeating, yet there is little research looking at practical strategies to reduce overeating in response to a negative mood. In three different experimental studies, we tested if exposure to music can reduce food consumption in a negative mood. Female undergraduates (N = 120-121 in each study) completed a measure of emotional eating and reported baseline hunger. Mood ratings were taken at baseline, post-mood induction and post-eating. All participants were given a mood induction (sadness for study 1, stress for studies 2 and 3) and allocated to one of three music conditions (self-chosen in study 3) or a silent (control) condition. Music was selected from three pieces reported by each participant as being listened to regularly when experiencing the negative mood being examined (sadness or stress) in order to provide solace (comforting music), diversion (distracting positive music), or discharge (angry and/or sad music). Participants were provided with several snack foods to consume whilst completing a mock taste test and intake (in grams) was compared between conditions. In study 1 participants in the music for discharge condition consumed less than those in the control condition. Moreover, participants with high levels of self-reported EE ate more crisps in the control than in the distraction condition. In study 2 participants in the solace condition consumed less than those in the control and discharge conditions. In study 3 most participants chose music for diversion; this did not, however, lead to lower consumption, despite a reduction in reported stress. Overall, the results of these studies indicate that listening to certain types of music might reduce emotion-related eating after controlling for hunger using a standardized pre-session snack.",2022,"Moreover, participants with high levels of self-reported EE ate more crisps in the control than in the distraction condition.",['Female undergraduates (N\u202f=\u202f120-121 in each study) completed a measure of emotional eating and reported baseline hunger'],"['negative mood being examined (sadness or stress) in order to provide solace (comforting music), diversion (distracting positive music), or discharge (angry and/or sad music']",['Mood ratings'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0185033', 'cui_str': 'Diversion procedure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.0893875,"Moreover, participants with high levels of self-reported EE ate more crisps in the control than in the distraction condition.","[{'ForeName': 'Annemieke J M', 'Initials': 'AJM', 'LastName': 'van den Tol', 'Affiliation': 'School of Psychology, University of Lincoln, Brayford Wharf East, Lincoln, LN5 7AY, United Kingdom. Electronic address: Avandentol@lincoln.ac.uk.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Coulthard', 'Affiliation': 'School of Applied Social Sciences, Faculty of Health & Life Sciences, De Montfort University, Leicester, LE1 9BH, United Kingdom. Electronic address: H.Coulhard@dmu.ac.uk.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Lang', 'Affiliation': 'School of Applied Social Sciences, Faculty of Health & Life Sciences, De Montfort University, Leicester, LE1 9BH, United Kingdom. Electronic address: p13189627@my365.dmu.ac.uk.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wallis', 'Affiliation': 'Department of Psychology, School of Social Sciences, Birmingham City University, Cardigan Street, Birmingham, B4 7DB, United Kingdom. Electronic address: Deborah.wallis@bcu.ac.uk.'}]",Appetite,['10.1016/j.appet.2022.105947']
1844,35101832,Efficacy of Bacillus clausii UBBC - 07 spores in the amelioration of oral mucositis in head and neck cancer patients undergoing radiation therapy.,"BACKGROUND


The natural flora of healthy mucosa offer protection to the host. The loss of this barrier during radiotherapy enhances insults from physical, chemical and microbial agents.
METHODOLOGY


A randomized, double blind, placebo-controlled, parallel study on forty-six patients who underwent radiotherapy for head and neck cancers was undertaken. Patients were randomized either to standard treatment plus Bacillus clausii UBBC07 or standard treatment plus placebo. Bacillus clausii UBBC07 was given as an oral suspension of 2 billion spores twice every day for 30 days or until completion of total fractions of radiation. Grading of the mucositis was performed using CTCAE v.4.03 severity scale. The time taken for the appearance, resolution and severity of mucositis was evaluated.
RESULTS


There was a significant increase (p < 0.01) in median time for the onset of mucositis i.e., 10 days in test and 8 days in control groups respectively. The median time for remission was found to be 12 days in test and 14 days in the control group (p < 0.05). Grade IV mucositis was observed in no patients in test group and 2 patients in the control group (p < 0.05). No adverse events attributed to the Bacillus clausii were seen. Bacillus clausii UBBC07 therapy delayed the onset, decreased the time to remission and displayed strong impact on suppressing the occurrence of high-grade mucositis amongst the test group.
CONCLUSIONS


This study provides a positive trend that probiotics like Bacillus clausii UBBC07 spores could act as a tool to ameliorate oral mucositis.",2022,Grade IV mucositis was observed in no patients in test group and 2 patients in the control group (p < 0.05).,"['forty-six patients who underwent radiotherapy for head and neck cancers was undertaken', 'head and neck cancer patients undergoing radiation therapy']","['placebo', 'standard treatment plus Bacillus clausii UBBC07 or standard treatment plus placebo', 'Bacillus clausii UBBC - 07 spores']","['oral mucositis', 'time taken for the appearance, resolution and severity of mucositis', 'occurrence of high-grade mucositis', 'Grade IV mucositis', 'time to remission', 'median time for remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1034048', 'cui_str': 'Bacillus clausii'}, {'cui': 'C0038027', 'cui_str': 'Spores'}]","[{'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",46.0,0.0803699,Grade IV mucositis was observed in no patients in test group and 2 patients in the control group (p < 0.05).,"[{'ForeName': 'Mehdi Ali', 'Initials': 'MA', 'LastName': 'Mirza', 'Affiliation': ""Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India. Electronic address: mehdialimirza@gmail.com.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aruna', 'Affiliation': ""Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Irukulla', 'Affiliation': ""Department of Radiation Oncology, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India.""}]",Cancer treatment and research communications,['10.1016/j.ctarc.2022.100523']
1845,35102364,"An extract of hops (Humulus lupulus L.) modulates gut peptide hormone secretion and reduces energy intake in healthy-weight men: a randomized, crossover clinical trial.","BACKGROUND


Gastrointestinal enteroendocrine cells express chemosensory bitter taste receptors that may play an important role in regulating energy intake (EI) and gut function.
OBJECTIVES


To determine the effect of a bitter hop extract (Humulus lupulus L.) on acute EI, appetite, and hormonal responses.
METHODS


Nineteen healthy-weight men completed a randomized 3-treatment, double-blind, crossover study with a 1-wk washout between treatments. Treatments comprised either placebo or 500 mg of hop extract administered in delayed-release capsules (duodenal) at 11:00 h or quick-release capsules (gastric) at 11:30 h. Ad libitum EI was recorded at the lunch (12:00 h) and afternoon snack (14:00 h), with blood samples taken and subjective ratings of appetite, gastrointestinal (GI) discomfort, vitality, meal palatability, and mood assessed throughout the day.
RESULTS


Total ad libitum EI was reduced following both the gastric (4473 kJ; 95% CI: 3811, 5134; P = 0.006) and duodenal (4439 kJ; 95% CI: 3777, 5102; P = 0.004) hop treatments compared with the placebo (5383 kJ; 95% CI: 4722, 6045). Gastric and duodenal treatments stimulated prelunch ghrelin secretion and postprandial cholecystokinin, glucagon-like peptide 1, and peptide YY responses compared with placebo. In contrast, postprandial insulin, glucose-dependent insulinotropic peptide, and pancreatic polypeptide responses were reduced in gastric and duodenal treatments without affecting glycemia. In addition, gastric and duodenal treatments produced small but significant increases in subjective measures of GI discomfort (e.g., nausea, bloating, abdominal discomfort) with mild to severe adverse GI symptoms reported in the gastric treatment only. However, no significant treatment effects were observed for any subjective measures of appetite or meal palatability.
CONCLUSIONS


Both gastric and duodenal delivery of a hop extract modulates the release of hormones involved in appetite and glycemic regulation, providing a potential ""bitter brake"" on EI in healthy-weight men.",2022,"In contrast, postprandial insulin, glucose-dependent insulinotropic peptide and pancreatic polypeptide responses were reduced in gastric and duodenal treatments without impacting glycemia.","['healthy-weight men', 'Nineteen healthy-weight men']","['placebo', 'placebo or 500\xa0mg of hop extract administered in delayed release capsules (duodenal) at 1100\xa0h or quick release capsules (gastric', 'bitter hop extract (Humulus lupulus L']","['blood samples taken and subjective ratings of appetite, gastrointestinal discomfort, vitality, meal palatability and mood assessed throughout the day', 'subjective measures of gastrointestinal discomfort (e.g., nausea, bloating, abdominal discomfort) with mild-severe adverse GI symptoms', 'Total ad libitum EI', 'acute EI, appetite and hormonal responses', 'subjective measures of appetite or meal palatability', 'postprandial insulin, glucose-dependent insulinotropic peptide and pancreatic polypeptide responses']","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4517537', 'cui_str': '1100'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0330544', 'cui_str': 'Humulus lupulus'}]","[{'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0030298', 'cui_str': 'Pancreatic peptide'}]",19.0,0.0902041,"In contrast, postprandial insulin, glucose-dependent insulinotropic peptide and pancreatic polypeptide responses were reduced in gastric and duodenal treatments without impacting glycemia.","[{'ForeName': 'Edward G', 'Initials': 'EG', 'LastName': 'Walker', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Auckland, New Zealand.'}, {'ForeName': 'Kim R', 'Initials': 'KR', 'LastName': 'Lo', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Auckland, New Zealand.'}, {'ForeName': 'Malcolm C', 'Initials': 'MC', 'LastName': 'Pahl', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Auckland, New Zealand.'}, {'ForeName': 'Hyun S', 'Initials': 'HS', 'LastName': 'Shin', 'Affiliation': 'Human Nutrition Unit; School of Biological Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lang', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Auckland, New Zealand.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Wohlers', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Auckland, New Zealand.'}, {'ForeName': 'Sally D', 'Initials': 'SD', 'LastName': 'Poppitt', 'Affiliation': 'Human Nutrition Unit; School of Biological Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kevin H', 'Initials': 'KH', 'LastName': 'Sutton', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Lincoln, New Zealand.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Ingram', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Auckland, New Zealand.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab418']
1846,35108625,"A Commentary on ""Effectiveness of local anesthetic application methods in postoperative pain control in laparoscopic cholecystectomies; a randomized controlled trial"" (Int J Surg 2021; 95: 106134).",,2022,,['postoperative pain control in laparoscopic cholecystectomies'],['local anesthetic application methods'],[],"[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],,0.319429,,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610072, Sichuan Province, China.'}, {'ForeName': 'Yi-Feng', 'Initials': 'YF', 'LastName': 'Ren', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610072, Sichuan Province, China. Electronic address: ryftcm.dr@yahoo.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, China. Electronic address: swhxmz@outlook.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2022.106236']
1847,35108610,"Efficacy and safety of Efavirenz 400 mg-based regimens switching from 600 mg-based regimens in people living with HIV with virological suppression in China: a randomized, open-label, non-inferiority study.","BACKGROUND


Efavirenz (EFV) 400 mg has been recommended to replace EFV 600 mg. There are only 200 mg and 600 mg dosage forms of EFV in China. Whether switching from one-tablet EFV 600 mg to two-tablet EFV 200 mg would weaken adherence or further affect efficacy or safety is unknown.
METHODS


Virologically suppressed people living with HIV with a regimen composed of one-tablet tenofovir (TDF), one-tablet lamivudine (3TC), and one-tablet EFV (600 mg) were randomized to continue original regimen or switch to two-tablet EFV (200 mg). Self-reported adherence questionnaires, 12-Item Short-Form Health Survey (SF-12), Hospital Anxiety and Depression Scale (HADS), and Pittsburgh Sleep Quality Index (PSQI) were used. Primary end point was the difference in proportions of participants with plasma HIV-RNA ≥ 50 copies/mL at week 48 with noninferiority margin of 4%.
RESULTS


A total of 209 participants were randomized to the EFV 400 mg group and 211 to the EFV 600 mg. Primary end point result was -3.3% (95% CI -8.1-1.6). Further decrease of GGT (-3.1 vs. -0.3 U/L) and TC (-0.26 vs. 0.12 U/L) was observed in EFV 400 mg participants through 48 weeks. No significant changes in adherence, quality of life, and neuropsychologic condition were reported.
CONCLUSIONS


EFV 400 mg was noninferior to EFV 600 mg and showed mild improvement of safety profile. Adherence was not weakened in patients taking EFV 400 mg. For patients taking EFV 600 mg with neuropsychologic symptoms, it would be better to switch to other drugs instead of EFV 400 mg.",2022,"No significant changes in adherence, quality of life and neuropsychologic condition were reported.
","['people living with HIV with virological suppression in China', 'Virologically suppressed PLWH with regimen comprised of one', '600mg patients with neuropsychologic symptoms', '209 participants']","['tablet TDF, one-tablet 3TC and one-tablet EFV', 'Efavirenz', 'Efavirenz (EFV', 'continue original regimen or switch to two-tablet EFV', 'EFV']","['Efficacy and safety', 'Adherence', 'proportions of participants with plasma HIV-RNA ≥ 50 copies/mL', 'safety profile', 'adherence, quality of life and neuropsychologic condition', 'Self-reported adherence questionnaires, SF-12, HADS and PSQI', 'GGT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}]",209.0,0.0910978,"No significant changes in adherence, quality of life and neuropsychologic condition were reported.
","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Peking University Ditan Teaching Hospital, Beijing, 100015, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'National Center for Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China; Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'National Center for Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China; Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'National Center for Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China; Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.'}, {'ForeName': 'Leidan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Peking University Ditan Teaching Hospital, Beijing, 100015, China.'}, {'ForeName': 'Junyan', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Beijing Key Laboratory of Emerging Infectious Diseases, Institute of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China; Beijing Institute of Infectious Diseases, Beijing, 100015, China; National Center for Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.'}, {'ForeName': 'Hongxin', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Peking University Ditan Teaching Hospital, Beijing, 100015, China; National Center for Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China; Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2022.01.051']
1848,35108604,Reducing childbirth-related intrusive memories and PTSD symptoms via a single-session behavioural intervention including a visuospatial task: A proof-of-principle study.,"BACKGROUND


Intrusive memories (IMs) of traumatic events are a key symptom of posttraumatic stress disorder (PTSD), and contribute to its maintenance. This translational proof-of-principle study tested whether a single-session behavioural intervention reduced the number of childbirth-related IMs (CB-IMs) and childbirth-related PTSD (CB-PTSD) symptoms, in women traumatised by childbirth. The intervention was assumed to disrupt trauma memory reconsolidation.
METHODS


In this pre-post study, 18 participants, whose traumatic childbirth had occurred between seven months and 6.9 years before, received an intervention combining childbirth-related reminder cues (including the return to maternity unit) with a visuospatial task. They recorded their daily CB-IMs in the two weeks pre-intervention (diary 1), the two weeks post-intervention (diary 2; primary outcome), and in week 5 and 6 post-intervention (diary 3). CB-PTSD symptom severity was assessed five days pre-intervention and one month post-intervention.
RESULTS


Compared to diary 1, 15/18 participants had ≥ 50% fewer CB-IMs in diary 2. The median (IQR) reduction of the number of CB-IMs was 81.89% (39.58%) in diary 2, and persisted in diary 3 (n = 17). At one month post-intervention, CB-PTSD symptom severity was reduced by ≥ 50% in 10/18 participants. Of the 8 participants with a CB-PTSD diagnosis pre-intervention, none met diagnostic criteria post-intervention. The intervention was rated as highly acceptable.
LIMITATIONS


The design limits the causal interpretation of observed improvements.
CONCLUSION


This is the first time such a single-session behavioural intervention was tested for old and real-life single-event trauma. The promising results justify a randomized controlled trial, and may be a first step toward an innovative CB-PTSD treatment.",2022,"At one month post-intervention, CB-PTSD symptom severity was reduced by ≥ 50% in 10/18 participants.","['8 participants with a CB-PTSD diagnosis pre-intervention, none met diagnostic criteria post-intervention', 'women traumatised by childbirth']",['intervention combining childbirth-related reminder cues (including the return to maternity unit) with a visuospatial task'],"['CB-PTSD symptom severity', 'number of childbirth-related IMs (CB-IMs) and childbirth-related PTSD (CB-PTSD) symptoms', 'median (IQR) reduction of the number of CB-IMs', 'traumatic childbirth', 'daily CB-IMs']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",18.0,0.126123,"At one month post-intervention, CB-PTSD symptom severity was reduced by ≥ 50% in 10/18 participants.","[{'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Deforges', 'Affiliation': 'Institute of Higher Education and Research in Healthcare (IUFRS), University of Lausanne and Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Déborah', 'Initials': 'D', 'LastName': 'Fort', 'Affiliation': 'Institute of Higher Education and Research in Healthcare (IUFRS), University of Lausanne and Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Suzannah', 'Initials': 'S', 'LastName': 'Stuijfzand', 'Affiliation': 'Institute of Higher Education and Research in Healthcare (IUFRS), University of Lausanne and Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Horsch', 'Affiliation': 'Institute of Higher Education and Research in Healthcare (IUFRS), University of Lausanne and Lausanne University Hospital, Lausanne, Switzerland; Woman-Mother-Child Department, Lausanne University Hospital, Lausanne, Switzerland. Electronic address: Antje.Horsch@chuv.ch.'}]",Journal of affective disorders,['10.1016/j.jad.2022.01.108']
1849,35106620,Residual effects of zopiclone on driving performance using a standardized driving simulator among healthy volunteers.,"RATIONALE


The effects of hypnotics on automobile driving have been attracting increasing attention. However, few driving simulators (DSs) have been confirmed to have acceptable reliability and validity for assessing the next-day residual effects of zopiclone as a positive control on driving performance.
OBJECTIVE


To investigate whether a new DS could permit detection of the next-day residual effects of zopiclone on driving performance.
METHODS


In this double-blind, randomized, placebo-controlled crossover trial, 28 healthy males received zopiclone 7.5 mg at bedtime on days 1 and 8 and placebo on the other days over a period of 16 days. The participants took part in three driving tasks-road-tracking, car-following, and harsh-braking-using a DS on days 2 and 9 at 9-h post-dosing. Scores on the Karolinska Sleepiness Scale and Profile of Mood States-Second Edition were then assessed, as was the serum concentration of zopiclone.
RESULTS


The estimated differences in the standard deviation of lateral position (cm) in the road-tracking task between the zopiclone and placebo groups on days 2 and 9 were 3.75 cm (90% confidence interval (CI): 1.71-5.79) and 4.07 cm (90% CI: 2.02-6.11), respectively. The estimated differences in the distance coefficient of variation in the car-following task and in the brake reaction time in the harsh-braking task between the zopiclone and placebo groups on day 2 were 4.31 (90% CI: 1.94-6.69) and 24.6 ms (90% CI: 12.7-36.4), respectively.
CONCLUSIONS


The DS used in this study has sufficient sensitivity to detect the next-day residual effects of zopiclone on driving performance.",2022,"The estimated differences in the distance coefficient of variation in the car-following task and in the brake reaction time in the harsh-braking task between the zopiclone and placebo groups on day 2 were 4.31 (90% CI: 1.94-6.69) and 24.6 ms (90% CI: 12.7-36.4), respectively.
","['28 healthy males received', 'healthy volunteers']","['placebo', 'zopiclone', 'zopiclone 7.5\xa0mg at bedtime on days 1 and 8 and placebo', 'hypnotics']","['serum concentration of zopiclone', 'Karolinska Sleepiness Scale and Profile of Mood States', 'standard deviation of lateral position (cm']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0078847', 'cui_str': 'zopiclone'}, {'cui': 'C1128536', 'cui_str': 'zopiclone 7.5 MG'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0078847', 'cui_str': 'zopiclone'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}]",28.0,0.213385,"The estimated differences in the distance coefficient of variation in the car-following task and in the brake reaction time in the harsh-braking task between the zopiclone and placebo groups on day 2 were 4.31 (90% CI: 1.94-6.69) and 24.6 ms (90% CI: 12.7-36.4), respectively.
","[{'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Iwamoto', 'Affiliation': 'Department of Psychiatry, Graduate School of Medicine, Nagoya University, 65 Tsurumai, Showa, Nagoya, Aichi, 466-8550, Japan. iwamoto@med.nagoya-u.ac.jp.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Iwata', 'Affiliation': 'Department of Psychiatry, Graduate School of Medicine, Nagoya University, 65 Tsurumai, Showa, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Daiji', 'Initials': 'D', 'LastName': 'Kambe', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd, Tokyo, 170-8633, Japan.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Imadera', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd, Tokyo, 170-8633, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Tachibana', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd, Tokyo, 170-8633, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kajiyama', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd, Tokyo, 170-8633, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Department of Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Aichi, 466-8560, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ozaki', 'Affiliation': 'Department of Psychiatry, Graduate School of Medicine, Nagoya University, 65 Tsurumai, Showa, Nagoya, Aichi, 466-8550, Japan.'}]",Psychopharmacology,['10.1007/s00213-022-06075-y']
1850,35114338,Mild moxibustion for Irritable Bowel Syndrome with Diarrhea (IBS-D): A randomized controlled trial.,"ETHNOPHARMACOLOGICAL RELEVANCE


Moxibustion therapy is a traditional Chinese medicine external treatment method, which involves crushing dried herb Artemisia argyi H. Lév. & Vanio and rolling it into a long cigarette-like strip, igniting it and using its warmth to stimulate specific acupuncture points for a certain period of time. It is often used in Asia to treat various diseases, especially abdominal pain. Clinical reports suggest that acupuncture and moxibustion are the effective treatment for Irritable Bowel Syndrome with Diarrhea (IBS-D). However, there is no placebo-controlled study to prove its safety and efficacy.
OBJECTIVE


To evaluate the effects of mild moxibustion (MM) for the treatment of irritable bowel syndrome with diarrhea (IBS-D) through comparisons with those of placebo moxibustion.
PATIENTS AND METHODS


This was a single-site, randomized controlled trial was conducted at Shanghai Research Institute of Acupuncture and Meridian in China and enrolled 76 participants who met the Rome IV diagnostic criteria for IBS-D between May 2017 and December 2019. 76 participants were randomized to either mild moxibustion (MM) or placebo moxibustion group (PM) in a 1:1 ratio. 18 sessions of MM or PM were implemented over the course of 6 weeks (3 times per week). The primary outcome was adequate relief after 6 weeks of treatment.
RESULTS


Of 76 patients with IBS-D who were randomized (38 in the MM group and 38 in the PM group) were included in the intention-to-treat (ITT) analysis set. After treatment at week 6, the response rate was significantly higher in the MM group than the PM group (81.58% vs. 36.84%) with an estimated difference of 44.74 (95% CI, 23.46 to 66.02, P < 0.001). No participant reported severe adverse effects.
CONCLUSION


The findings suggest that mild moxibustion may be more effective than placebo moxibustion for the treatment of IBS-D, with effects lasting up to 12 weeks.
TRIAL REGISTRATION


ChiCTR, ChiCTR2100046852. Registered 29 May 2021 - Retrospectively registered, URL: http://www.chictr.org.cn/showproj.aspx?proj=127000.",2022,"After treatment at week 6, the response rate was significantly higher in the MM group than the PM group (81.58% vs. 36.84%) with an estimated difference of 44.74 (95% CI, 23.46 to 66.02, P < 0.001).","['76 patients with IBS-D who were randomized (38 in the MM group and 38 in the PM group) were included in the intention-to-treat (ITT) analysis set', 'in China and enrolled 76 participants who met the Rome IV diagnostic criteria for IBS-D between May 2017 and December 2019', '76 participants', 'irritable bowel syndrome with diarrhea (IBS-D', 'Irritable Bowel Syndrome with Diarrhea (IBS-D']","['placebo', 'mild moxibustion (MM', 'acupuncture and moxibustion', 'placebo moxibustion', 'Mild moxibustion', 'Acupuncture and Meridian', 'mild moxibustion (MM) or placebo moxibustion']","['severe adverse effects', 'adequate relief', 'response rate', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348898', 'cui_str': 'Irritable bowel syndrome with diarrhea'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",76.0,0.294164,"After treatment at week 6, the response rate was significantly higher in the MM group than the PM group (81.58% vs. 36.84%) with an estimated difference of 44.74 (95% CI, 23.46 to 66.02, P < 0.001).","[{'ForeName': 'Zhaoqin', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Aeronautics and Astronautics, Shanghai Key Laboratory of Acupuncture Mechanism and Acupoint Function, Fudan University, Shanghai, 200433, China. Electronic address: wangzhaoqin@fudan.edu.cn.'}, {'ForeName': 'Manwen', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, Huashan Hospital, Fudan University, Shanghai, 200040, China. Electronic address: merelyric_white@163.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China. Electronic address: shizhengmm@163.com.'}, {'ForeName': 'Chunhui', 'Initials': 'C', 'LastName': 'Bao', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China. Electronic address: baochunhui789@126.com.'}, {'ForeName': 'Huirong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China. Electronic address: lhr_tcm@139.com.'}, {'ForeName': 'Cili', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China. Electronic address: zhoucili2010@126.com.'}, {'ForeName': 'Yilu', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China; Yueyang Hospital of Integrative Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. Electronic address: 18001861046@163.com.'}, {'ForeName': 'Chunye', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China; Yueyang Hospital of Integrative Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. Electronic address: Daisywang666@163.com.'}, {'ForeName': 'Guona', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China; Yueyang Hospital of Integrative Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. Electronic address: liguonaaa@163.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, School of Public Health, Fudan University, Shanghai, 200032, China. Electronic address: weizhang@shmu.edu.cn.'}, {'ForeName': 'Anqi', 'Initials': 'A', 'LastName': 'Gao', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China; Yueyang Hospital of Integrative Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. Electronic address: 13817206183@163.com.'}, {'ForeName': 'Huangan', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China. Electronic address: wuhuangan@126.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2022.115064']
1851,35114353,What's in the Sauce? The Specific Benefits of Palliative Care for Parkinson's Disease.,"CONTEXT


Increasing evidence demonstrates the benefits of palliative care among individuals with Parkinson's disease and related disorders (PDRD), but the critical components that contribute to therapeutic effects are not well understood.
OBJECTIVES


To determine the specific items most responsive to a palliative care intervention in PDRD and identify key correlates of improvement in patient and care partner outcomes.
METHODS


The main trial was a pragmatic comparative effectiveness trial of outpatient integrated palliative care compared to standard care among participants with PDRD (NCT02533921), showing significantly higher patient QOL at six months and lower care partner burden at 12 months. We used longitudinal regression models to analyze changes in subdomains of patient QOL and care partner burden and Spearman correlations to evaluate key correlates of change scores in patient and care partner outcomes. We performed a secondary analysis of data from 210 patients and 175 care partners.
RESULTS


Compared to controls, patients in the intervention reported greater improvement in perceptions of the ""self as a whole"" at six months (coeff = 0.22, P < 0.05) and care partners reported greater reduction in stress, anger, and loss of control at 12 months (coeff = -.40, -0.25, -0.31, P < 0.05). Positive change in numerous patient non-motor symptoms and grief correlated with improved patient QOL, reduced patient anxiety, and increased care partner spirituality. Alleviation of care partner anxiety and depression correlated with reduced care partner burden.
CONCLUSION


Specific benefits of an integrated palliative approach in PDRD include improvement in patient holistic self-impressions, care partner self-efficacy, and non-motor symptoms.",2022,"Compared to controls, patients in the intervention reported greater improvement in perceptions of the ""self as a whole"" at 6 months (coeff=0.22, p<0.05) and care partners reported greater reduction in stress, anger, and loss of control at 12 months (coeff =-.40, -0.25, -0.31, p<0.05).","['participants with PDRD (NCT02533921), showing significantly higher patient QOL at 6 months and lower care partner burden at 12 months', '210 patients and 175 care partners', ""individuals with Parkinson's disease and related disorders (PDRD""]",['outpatient integrated palliative care'],"['stress, anger, and loss of control', 'patient holistic self-impressions, care partner self-efficacy', 'Alleviation of care partner anxiety and depression', 'perceptions of the ""self', 'patient anxiety, and increased care partner spirituality']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}]",210.0,0.0600204,"Compared to controls, patients in the intervention reported greater improvement in perceptions of the ""self as a whole"" at 6 months (coeff=0.22, p<0.05) and care partners reported greater reduction in stress, anger, and loss of control at 12 months (coeff =-.40, -0.25, -0.31, p<0.05).","[{'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Bock', 'Affiliation': 'Department of Neurology, University of California, San Francisco, California, USA; San Francisco Veterans Affairs Medical Center, San Francisco, California, USA. Electronic address: Meredith.Bock@ucsf.edu.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Katz', 'Affiliation': 'Department of Neurology, Stanford University, California, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sillau', 'Affiliation': 'Department of Neurology, University of Colorado Anschutz Medical Campus, Colorado, USA.'}, {'ForeName': 'Kwame', 'Initials': 'K', 'LastName': 'Adjepong', 'Affiliation': 'Department of Neurology, University of California, San Francisco, California, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Yaffe', 'Affiliation': 'Department of Neurology, University of Colorado Anschutz Medical Campus, Colorado, USA; Department of Psychiatry, University of California, San Francisco, California, USA; Department of Epidemiology, University of California, San Francisco, California, USA.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Ayele', 'Affiliation': 'Department of Health Systems, Management and Policy, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Macchi', 'Affiliation': 'Department of Neurology, University of Colorado Anschutz Medical Campus, Colorado, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pantilat', 'Affiliation': 'Department of Medicine, Division of Palliative Medicine at University of California, San Francisco California, USA.'}, {'ForeName': 'Janis M', 'Initials': 'JM', 'LastName': 'Miyasaki', 'Affiliation': 'Department of Medicine, Division of Neurology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Benzi', 'Initials': 'B', 'LastName': 'Kluger', 'Affiliation': 'Departments of Neurology and Medicine, Division of Palliative Care, University of Rochester, Rochester, New Year, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2022.01.017']
1852,35113639,A comparison of emotion-focused therapy and cognitive-behavioral therapy in the treatment of generalized anxiety disorder: Results of a feasibility randomized controlled trial.,"Generalized anxiety disorder (GAD) is a chronic mental health difficulty typically present in primary care settings. Cognitive-behavioral therapy (CBT) is the psychological intervention with the best evidence for its efficacy for GAD. The development of other psychological interventions can increase client choice. This feasibility trial examined an initial assessment of the efficacy of EFT in comparison to CBT in the treatment of GAD in the context of an Irish public health service. The trial provided information on recruitment, therapist training/adherence, and client retention relevant for a potential noninferiority trial. A randomized controlled trial compared the efficacy of EFT versus CBT for GAD. Both therapies were offered in a 16-20 sessions format. Therapists ( n  = 8) were trained in both conditions and offered both therapies. Clients were randomly assigned to the two therapies EFT ( n  = 29) and CBT ( n  = 29). Outcomes were assessed using several measures, with the Generalized Anxiety Disorder-7 (GAD-7) being the primary outcome. Clients were assessed at baseline, week 16, end of therapy, and at 6-month follow-up. Therapists were able to learn the two models after a short training and showed moderate levels of adherence. Although not statistically significant, the drop out from treatment was 10% for EFT and 27% for CBT. The two therapies showed large pre-post change and similar outcomes across all measures, with these benefits retained at 6-month follow-up. Results suggest that EFT is a potentially promising treatment for GAD. Further investigation is indicated to establish its potential to expand the available psychological therapies for GAD. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,"Although not statistically significant, the drop out from treatment was 10% for EFT and 27% for CBT.",['generalized anxiety disorder'],"['emotion-focused therapy and cognitive-behavioral therapy', 'EFT', 'CBT', 'Cognitive-behavioral therapy (CBT']","['Generalized Anxiety Disorder-7 (GAD-7', 'moderate levels of adherence', 'Generalized anxiety disorder (GAD']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C4277722', 'cui_str': 'Emotion-Focused Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0624722,"Although not statistically significant, the drop out from treatment was 10% for EFT and 27% for CBT.","[{'ForeName': 'Ladislav', 'Initials': 'L', 'LastName': 'Timulak', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Daragh', 'Initials': 'D', 'LastName': 'Keogh', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Chigwedere', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Wilson', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Ward', 'Affiliation': 'HSE National Counselling Service.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hevey', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Griffin', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jacobs', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Vaughan', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Kea', 'Initials': 'K', 'LastName': 'Beckham', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Shona', 'Initials': 'S', 'LastName': 'Mahon', 'Affiliation': 'School of Psychology.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000427']
1853,35113940,Effects of a group-based weight management programme on anxiety and depression: A randomised controlled trial (RCT).,"OBJECTIVES


The aim was to investigate the impact of a group-based weight management programme on symptoms of depression and anxiety compared with self-help in a randomised controlled trial (RCT).
METHOD


People with overweight (Body Mass Index [BMI]≥28kg/m2) were randomly allocated self-help (n = 211) or a group-based weight management programme for 12 weeks (n = 528) or 52 weeks (n = 528) between 18/10/2012 and 10/02/2014. Symptoms were assessed using the Hospital Anxiety and Depression Scale, at baseline, 3, 12 and 24 months. Linear regression modelling examined changes in Hospital Anxiety and Depression Scale between trial arms.
RESULTS


At 3 months, there was a -0.6 point difference (95% confidence interval [CI], -1.1, -0.1) in depression score and -0.1 difference (95% CI, -0.7, 0.4) in anxiety score between group-based weight management programme and self-help. At subsequent time points there was no consistent evidence of a difference in depression or anxiety scores between trial arms. There was no evidence that depression or anxiety worsened at any time point.
CONCLUSIONS


There was no evidence of harm to depression or anxiety symptoms as a result of attending a group-based weight loss programme. There was a transient reduction in symptoms of depression, but not anxiety, compared to self-help. This effect equates to less than 1 point out of 21 on the Hospital Anxiety and Depression Scale and is not clinically significant.",2022,There was no evidence of harm to depression or anxiety symptoms as a result of attending a group-based weight loss programme.,['People with overweight'],['group-based weight management programme'],"['Body Mass Index', 'depression score', 'anxiety and depression', 'symptoms of depression and anxiety', 'depression or anxiety', 'harm to depression or anxiety symptoms', 'symptoms of depression', 'Hospital Anxiety and Depression Scale', 'depression or anxiety scores', 'anxiety score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}]",528.0,0.173752,There was no evidence of harm to depression or anxiety symptoms as a result of attending a group-based weight loss programme.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Heath', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stevens', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Wheeler', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Ahern', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Boyland', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Halford', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0263228']
1854,35113938,"Physical exercise is associated with a reduction in plasma levels of fractalkine, TGF-β1, eotaxin-1 and IL-6 in younger adults with mobility disability.","Mobility disability (MD) refers to substantial limitations in life activities that arise because of movement impairments. Although MD is most prevalent in older individuals, it can also affect younger adults. Increasing evidence suggests that inflammation can drive the development of MD and may need to be targeted for MD prevention. Physical exercise has anti-inflammatory properties and has been associated with MD prevention. However, no studies to date have examined whether exercise interventions affect the peripheral inflammatory status in younger adults with MD. To this end, we used blood samples from young and middle-aged adults with MD (N = 38; median age = 34 years) who participated in a 12-week intervention that included aerobic and resistance exercise training. A pre-post assessment of inflammatory biomarkers was conducted in plasma from two timepoints, i.e., before the exercise trial and at follow-up (3-7 days after the last exercise session). We successfully measured 15 inflammatory biomarkers and found that exercise was associated with a significant reduction in levels of soluble fractalkine, transforming growth factor beta 1 (TGF-β1), eotaxin-1 and interleukin (IL) 6 (corrected α = 0.004). We also found significant male-specific effects of exercise on (i) increasing IL-16 and (ii) decreasing vascular endothelial growth factor-A (VEGF-A). In line with our results, previous studies have also found that exercise can reduce levels of TGF-β1, eotaxin-1 and IL-6. However, our finding that exercise reduces plasma levels of fractalkine in younger adults with MD, as well as the sex-dependent findings, have not been previously reported and warrant replication in larger cohorts. Given the suggested role of inflammation in promoting MD development, our study provides additional support for the use of physical exercise as a treatment modality for MD.",2022,"We successfully measured 15 inflammatory biomarkers and found that exercise was associated with a significant reduction in levels of soluble fractalkine, transforming growth factor beta 1 (TGF-β1), eotaxin-1 and interleukin (IL) 6 (corrected α = 0.004).","['younger adults with mobility disability', 'young and middle-aged adults with MD (N = 38; median age = 34 years) who participated in a 12-week intervention that included', 'younger adults with MD']","['exercise interventions', 'Physical exercise', 'aerobic and resistance exercise training', 'physical exercise']","['plasma levels of fractalkine', 'levels of soluble fractalkine, transforming growth factor beta 1 (TGF-β1), eotaxin-1 and interleukin (IL', 'Mobility disability (MD', 'IL-16 and (ii) decreasing vascular endothelial growth factor-A (VEGF-A', 'peripheral inflammatory status', 'plasma levels of fractalkine, TGF-β1, eotaxin-1 and IL-6']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0535298', 'cui_str': 'Fractalkine'}, {'cui': 'C0080222', 'cui_str': 'TGFB1 protein, human'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0250604', 'cui_str': 'Eotaxin-1'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0065337', 'cui_str': 'Lymphocyte Chemoattractant Factor'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.0162024,"We successfully measured 15 inflammatory biomarkers and found that exercise was associated with a significant reduction in levels of soluble fractalkine, transforming growth factor beta 1 (TGF-β1), eotaxin-1 and interleukin (IL) 6 (corrected α = 0.004).","[{'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Stiernborg', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fogdell-Hahn', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Månsson', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Furmark', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Berglind', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Philippe A', 'Initials': 'PA', 'LastName': 'Melas', 'Affiliation': 'Center for Molecular Medicine, L8:00, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Forsell', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Lavebratt', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0263173']
1855,35114511,Design and ergonomic assessment of a passive head/neck supporting exoskeleton for overhead work use.,"Overhead work is an important risk factor associated with musculoskeletal disorders of the neck and shoulder region. This study aimed to propose and evaluate a passive head/neck supporting exoskeleton (HNSE) as a potential ergonomic intervention for overhead work applications. Fourteen male participants were asked to perform a simulated overhead task of fastening/unfastening nut in 4 randomized sessions, characterized by two variables: neck extension angle (40% and 80% of neck maximum range of motion) and exoskeleton condition (wearing and not wearing the HNSE). Using the HNSE, significantly alleviated perceived discomfort in the neck (p-value = 0.009), right shoulder (p-value = 0.05) and left shoulder (p-value = 0.02) and reduced electromyographic activity of the right (p-value = 0.005) and left (p-value = 0.01) sternocleidomastoid muscles. However, utilizing the exoskeleton caused a remarkable increase in right (p-value = 0.04) and left (p-value = 0.05) trapezius electromyographic activities. Performance was not significantly affected by the HNSE. Although the HNSE had promising effects with respect to discomfort and muscular activity in the static overhead task, future work is still needed to investigate its effect on performance and to provide support for the generalizability of study results.",2022,"Using the HNSE, significantly alleviated perceived discomfort in the neck (p-value = 0.009), right shoulder (p-value = 0.05) and left shoulder (p-value = 0.02) and reduced electromyographic activity of the right (p-value = 0.005) and left (p-value = 0.01) sternocleidomastoid muscles.",['Fourteen male participants'],"['simulated overhead task of fastening/unfastening nut in 4 randomized sessions, characterized by two variables: neck extension angle (40% and 80% of neck maximum range of motion) and exoskeleton condition (wearing and not wearing the HNSE', 'HNSE', 'passive head/neck supporting exoskeleton (HNSE']","['Performance', 'trapezius electromyographic activities', 'right shoulder', 'reduced electromyographic activity', 'left shoulder']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0453981', 'cui_str': 'Fastening'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0524468', 'cui_str': 'Structure of right shoulder region'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]",14.0,0.0195216,"Using the HNSE, significantly alleviated perceived discomfort in the neck (p-value = 0.009), right shoulder (p-value = 0.05) and left shoulder (p-value = 0.02) and reduced electromyographic activity of the right (p-value = 0.005) and left (p-value = 0.01) sternocleidomastoid muscles.","[{'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Garosi', 'Affiliation': 'Department of Occupational Health Engineering, School of Public Health, Tehran University of Medical Sciences, Iran; Department of Ergonomics, School of Public Health, Iran University of Medical Sciences, Iran.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Mazloumi', 'Affiliation': 'Department of Occupational Health Engineering, School of Public Health, Tehran University of Medical Sciences, Iran; Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: amazlomi@tums.ac.ir.'}, {'ForeName': 'Amir Homayoun', 'Initials': 'AH', 'LastName': 'Jafari', 'Affiliation': 'Medical Physics & Biomedical Engineering Department, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmadreza', 'Initials': 'A', 'LastName': 'Keihani', 'Affiliation': 'Medical Physics & Biomedical Engineering Department, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Shamsipour', 'Affiliation': 'Department of Research Methodology and Data Analysis, Institute for Environmental Research, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Kordi', 'Affiliation': 'Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Kazemi', 'Affiliation': 'Department of Ergonomics, School of Public Health, Iran University of Medical Sciences, Iran.'}]",Applied ergonomics,['10.1016/j.apergo.2022.103699']
1856,34904799,Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma.,"BACKGROUND


Diffuse large B-cell lymphoma (DLBCL) is typically treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). However, only 60% of patients are cured with R-CHOP. Polatuzumab vedotin is an antibody-drug conjugate targeting CD79b, which is ubiquitously expressed on the surface of malignant B cells.
METHODS


We conducted a double-blind, placebo-controlled, international phase 3 trial to evaluate a modified regimen of R-CHOP (pola-R-CHP), in which vincristine was replaced with polatuzumab vedotin, as compared with standard R-CHOP, in patients with previously untreated intermediate-risk or high-risk DLBCL. Patients 18 to 80 years of age were randomly assigned in a 1:1 ratio to receive six cycles of either pola-R-CHP or R-CHOP, plus two cycles of rituximab alone. The primary end point was investigator-assessed progression-free survival. Secondary end points included overall survival and safety.
RESULTS


Overall, 879 patients underwent randomization: 440 were assigned to the pola-R-CHP group and 439 to the R-CHOP group. After a median follow-up of 28.2 months, the percentage of patients surviving without progression was significantly higher in the pola-R-CHP group than in the R-CHOP group (76.7% [95% confidence interval (CI), 72.7 to 80.8] vs. 70.2% [95% CI, 65.8 to 74.6] at 2 years; stratified hazard ratio for progression, relapse, or death, 0.73 by Cox regression; 95% CI, 0.57 to 0.95; P = 0.02). Overall survival at 2 years did not differ significantly between the groups (88.7% [95% CI, 85.7 to 91.6] in the pola-R-CHP group and 88.6% [95% CI, 85.6 to 91.6] in the R-CHOP group; hazard ratio for death, 0.94; 95% CI, 0.65 to 1.37; P = 0.75). The safety profile was similar in the two groups.
CONCLUSIONS


Among patients with previously untreated intermediate-risk or high-risk DLBCL, the risk of disease progression, relapse, or death was lower among those who received pola-R-CHP than among those who received R-CHOP. (Funded by F. Hoffmann-La Roche/Genentech; POLARIX ClinicalTrials.gov number, NCT03274492.).",2022,"Overall survival at 2 years did not differ significantly between the groups (88.7% [95% CI, 85.7 to 91.6] in the pola-R-CHP group and 88.6% [95% CI, 85.6 to 91.6] in the R-CHOP group; hazard ratio for death, 0.94; 95% CI, 0.65 to 1.37; P = 0.75).","['patients with previously untreated intermediate-risk or high-risk DLBCL', '879 patients underwent randomization', 'Patients 18 to 80 years of age']","['placebo', 'vincristine', 'pola-R-CHP or R-CHOP, plus two cycles of rituximab alone', 'R-CHOP (pola-R-CHP', 'pola-R-CHP', 'rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP']","['Overall survival', 'investigator-assessed progression-free survival', 'risk of disease progression, relapse, or death', 'overall survival and safety', 'safety profile', 'hazard ratio for progression, relapse, or death', 'percentage of patients surviving without progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",879.0,0.705043,"Overall survival at 2 years did not differ significantly between the groups (88.7% [95% CI, 85.7 to 91.6] in the pola-R-CHP group and 88.6% [95% CI, 85.6 to 91.6] in the R-CHOP group; hazard ratio for death, 0.94; 95% CI, 0.65 to 1.37; P = 0.75).","[{'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Tilly', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morschhauser', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Trněný', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Jeff P', 'Initials': 'JP', 'LastName': 'Sharman', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Herbaux', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Burke', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Matasar', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Rai', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Izutsu', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Mehta-Shah', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Oberic', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Chauchet', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Jurczak', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Larysa', 'Initials': 'L', 'LastName': 'Mykhalska', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'Bergua-Burgués', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Cheung', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pinto', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Hapgood', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Munhoz', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Abrisqueta', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Jyh-Pyng', 'Initials': 'JP', 'LastName': 'Gau', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Hirata', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Yanwen', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Flowers', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': ""From the Department of Hematology and INSERM Unité 1245, Centre Henri-Becquerel and University of Rouen, Rouen (H.T.), Université\xa0de Lille, Centre Hospitalier Universitaire (CHU) Lille, ULR 7365 - GRITA - Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille (F.M.), CHU de Montpellier, Montpellier (C.H.), the Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse (L.O.), and the Department of Hematology, Centre Hospitalier Régional Universitaire - Besançon, Besançon (A.C.) - all in France; the Centre for Lymphoid Cancer at BC Cancer and the University of British Columbia, Vancouver (L.H.S.), the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto (M.C.C.), and F. Hoffmann-La Roche, Mississauga, ON (M.Y.) - all in Canada; the Wilmot Cancer Institute, University of Rochester, Rochester (J.W.F.), and Memorial Sloan Kettering Cancer Center, New York (M.M., G.S.) - both in New York; the First Faculty of Medicine, Charles University and the General University Hospital, Prague, Czech Republic (M.T.); the Willamette Valley Cancer Institute and Research Center, the US Oncology Network, Eugene, OR (J.P.S.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Memorial Sloan Kettering Cancer Center, Montvale, NJ (M.M.); the Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City (S.R.), and the National Cancer Center Hospital, Tokyo (K.I.) - both in Japan; Washington University in St. Louis, St. Louis (N.M.-S.); the Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland (W.J.); Peking University Cancer Hospital, Beijing (Y.S.); the 3rd Medical Department, Paracelsus Medical University, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, and Cancer Cluster Salzburg, Salzburg, Austria (R.G.); the Feofaniya Clinical Hospital, Kyiv, Ukraine (L.M.); Hospital San Pedro de Alcántara, Cáceres (J.M.B.-B.), and the Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (P.A.) - both in Spain; the Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Naples, Italy (A.P.); the Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea (H.-J.S.); Princess Alexandra Hospital, Brisbane, QLD, Australia (G.H.); Hospital Erasto Gaertner, Curitiba, Brazil (E.M.); Taipei Veterans General Hospital, Taipei, Taiwan (J.-P.G.); Genentech, South San Francisco, CA (J.H., Y.J., C.L.); and M.D. Anderson Cancer Center, Houston (C.R.F.).""}]",The New England journal of medicine,['10.1056/NEJMoa2115304']
1857,35106617,Effect of therapeutic drug monitoring-based dose optimization of piperacillin/tazobactam on sepsis-related organ dysfunction in patients with sepsis: a randomized controlled trial.,"PURPOSE


Insufficient antimicrobial exposure is associated with worse outcomes in sepsis. We evaluated whether therapeutic drug monitoring (TDM)-guided antibiotic therapy improves outcomes.
METHODS


Randomized, multicenter, controlled trial from January 2017 to December 2019. Adult patients (n = 254) with sepsis or septic shock were randomly assigned 1:1 to receive continuous infusion of piperacillin/tazobactam with dosing guided by daily TDM of piperacillin or continuous infusion with a fixed dose (13.5 g/24 h if eGFR ≥ 20 mL/min). Target plasma concentration was four times the minimal inhibitory concentration (range ± 20%) of the underlying pathogen, respectively, of Pseudomonas aeruginosa in empiric situation. Primary outcome was the mean of daily total Sequential Organ Failure Assessment (SOFA) score up to day 10.
RESULTS


Among 249 evaluable patients (66.3 ± 13.7 years; female, 30.9%), there was no significant difference in mean SOFA score between patients with TDM (7.9 points; 95% CI 7.1-8.7) and without TDM (8.2 points; 95% CI 7.5-9.0) (p = 0.39). Patients with TDM-guided therapy showed a lower 28-day mortality (21.6% vs. 25.8%, RR 0.8, 95% CI 0.5-1.3, p = 0.44) and a higher rate of clinical (OR 1.9; 95% CI 0.5-6.2, p = 0.30) and microbiological cure (OR 2.4; 95% CI 0.7-7.4, p = 0.12), but these differences did not reach statistical significance. Attainment of target concentration was more common in patients with TDM (37.3% vs. 14.6%, OR 4.5, CI 95%, 2.9-6.9, p < 0.001).
CONCLUSION


TDM-guided therapy showed no beneficial effect in patients with sepsis and continuous infusion of piperacillin/tazobactam with regard to the mean SOFA score. Larger studies with strategies to ensure optimization of antimicrobial exposure are needed to definitively answer the question.",2022,"Patients with TDM-guided therapy showed a lower 28-day mortality (21.6% vs. 25.8%, RR 0.8, 95% CI 0.5-1.3, p = 0.44) and a higher rate of clinical (OR 1.9; 95% CI 0.5-6.2, p = 0.30) and microbiological cure (OR 2.4; 95% CI 0.7-7.4, p = 0.12), but these differences did not reach statistical significance.","['Adult patients (n\u2009=\u2009254) with sepsis or septic shock', 'patients with sepsis', 'January 2017 to December 2019']","['therapeutic drug monitoring (TDM)-guided antibiotic therapy', 'TDM-guided therapy', 'piperacillin/tazobactam with dosing guided by daily TDM of piperacillin', 'piperacillin/tazobactam']","['mean of daily total Sequential Organ Failure Assessment (SOFA) score', 'sepsis-related organ dysfunction', 'mean SOFA score', 'Attainment of target concentration', '28-day mortality', 'microbiological cure', 'Target plasma concentration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}]","[{'cui': 'C1720825', 'cui_str': 'Therapeutic Drug Monitoring'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0250480', 'cui_str': 'Piperacillin and tazobactam'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031955', 'cui_str': 'Piperacillin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.214792,"Patients with TDM-guided therapy showed a lower 28-day mortality (21.6% vs. 25.8%, RR 0.8, 95% CI 0.5-1.3, p = 0.44) and a higher rate of clinical (OR 1.9; 95% CI 0.5-6.2, p = 0.30) and microbiological cure (OR 2.4; 95% CI 0.7-7.4, p = 0.12), but these differences did not reach statistical significance.","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hagel', 'Affiliation': 'Institute for Infectious Diseases and Infection Control, Jena University Hospital-Friedrich Schiller University Jena, Am Klinikum 1, 07747, Jena, Germany. stefan.hagel@med.uni-jena.de.'}, {'ForeName': 'Friedhelm', 'Initials': 'F', 'LastName': 'Bach', 'Affiliation': 'Department of Infectious Diseases, Evangelisches Klinikum Bethel, Bielefeld, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Brenner', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Bracht', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Brinkmann', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, General Hospital of Heidenheim, Heidenheim, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Annecke', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Faculty of Medicine, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hohn', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Faculty of Medicine, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Weigand', 'Affiliation': 'Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Michels', 'Affiliation': 'Department of Acute and Emergency Care, St.-Antonius-Hospital gGmbH, Eschweiler, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kluge', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Nierhaus', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Jarczak', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'König', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Weismann', 'Affiliation': 'Medizinische Klinik Und Poliklinik I, Internistische Notfall- und Intensivmedizin, Universitätsklinikum Würzburg, Würzburg, Germany.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Frey', 'Affiliation': 'Department of Pharmacy, General Hospital of Heidenheim, Heidenheim, Germany.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Witzke', 'Affiliation': 'Department of Infectious Diseases, Evangelisches Klinikum Bethel, Bielefeld, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Müller', 'Affiliation': 'Centre of Pharmacology, Department of Therapeutic Drug Monitoring, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'Department of Anesthesiology and Intensive Care Therapy, Jena University Hospital-Friedrich Schiller University Jena, Jena, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kiehntopf', 'Affiliation': 'Department of Clinical Chemistry and Laboratory Medicine, Jena University Hospital-Friedrich Schiller University Jena, Jena, Germany.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Neugebauer', 'Affiliation': 'Center for Sepsis Control and Care (CSCC), Jena University Hospital-Friedrich Schiller University Jena, Jena, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': 'Institute of Medical Statistics, Computer Sciences and Data Sciences, Jena University Hospital-Friedrich Schiller University Jena, Jena, Germany.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Roberts', 'Affiliation': 'University of Queensland Centre for Clinical Research, and School of Pharmacy, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Mathias W', 'Initials': 'MW', 'LastName': 'Pletz', 'Affiliation': 'Institute for Infectious Diseases and Infection Control, Jena University Hospital-Friedrich Schiller University Jena, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-021-06609-6']
1858,35073733,PIVOT-12: a phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence.,"Bempegaldesleukin (BEMPEG: NKTR-214) is an immunostimulatory IL-2 cytokine prodrug engineered to deliver a controlled, sustained and preferential IL-2 pathway signal. Nivolumab (NIVO), a PD-1 inhibitor, has been shown to prolong survival in patients with advanced melanoma and recurrence-free survival in the adjuvant setting. PIVOT-02 showed that BEMPEG plus NIVO was well-tolerated and demonstrated clinical activity as first-line therapy in metastatic melanoma. PIVOT-12 is a randomized, phase III, global, multicenter, open-label study comparing adjuvant therapy with BEMPEG plus NIVO versus NIVO alone in adult and adolescent patients with completely resected cutaneous stage III/IV melanoma at high risk of recurrence. The primary objective is to compare the efficacy, as measured by recurrence-free survival, of BEMPEG plus NIVO versus NIVO.",2022,"The primary objective is to compare the efficacy, as measured by recurrence-free survival, of BEMPEG plus NIVO versus NIVO.","['patients with advanced melanoma', 'adult and adolescent patients with completely resected cutaneous stage III/IV melanoma at high risk of recurrence', 'resected stage III/IV melanoma at high risk for recurrence']","['Nivolumab (NIVO', 'BEMPEG plus NIVO versus NIVO alone', 'adjuvant bempegaldesleukin plus nivolumab']",['tolerated and demonstrated clinical activity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.395236,"The primary objective is to compare the efficacy, as measured by recurrence-free survival, of BEMPEG plus NIVO versus NIVO.","[{'ForeName': 'Alexander Mm', 'Initials': 'AM', 'LastName': 'Eggermont', 'Affiliation': 'Princess Máxima Center for Pediatric Oncology & University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione G\xa0Pascale, Naples, Italy.'}, {'ForeName': 'Nikhil I', 'Initials': 'NI', 'LastName': 'Khushalani', 'Affiliation': 'H\xa0Lee Moffitt Cancer Center & Research Institute, Tampa, FL 33612, USA.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'West German Cancer Center at the University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Boland', 'Affiliation': 'Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Weber', 'Affiliation': 'Perlmutter Cancer Center at NYU Langone Health, New York, NY 10016, USA.'}, {'ForeName': 'Karl D', 'Initials': 'KD', 'LastName': 'Lewis', 'Affiliation': 'University of Colorado Cancer Center, Aurora, CO 80045, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'Ochsner Medical Center, New Orleans, LA 70121, USA.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Rivalland', 'Affiliation': 'University of Auckland & Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Khattak', 'Affiliation': 'Hollywood Private Hospital, Edith Cowan University, Perth, Australia.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gogas', 'Affiliation': 'National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, & Royal North Shore & Mater Hospitals, Sydney, Australia.'}, {'ForeName': 'Sue L', 'Initials': 'SL', 'LastName': 'Currie', 'Affiliation': 'Nektar Therapeutics, San Francisco, CA 94158, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Nektar Therapeutics, San Francisco, CA 94158, USA.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Tagliaferri', 'Affiliation': 'Nektar Therapeutics, San Francisco, CA 94158, USA.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Westmead & Blacktown Hospitals & Melanoma Institute Australia, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Diab', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.'}]","Future oncology (London, England)",['10.2217/fon-2021-1286']
1859,35119462,Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Test Kit on Colorectal Cancer Screening Rates: A Randomized Clinical Trial.,"Importance


Colorectal cancer (CRC) screening reduces CRC mortality; however, screening rates remain well below the national benchmark of 80%.
Objective


To determine whether an electronic primer message delivered through the patient portal increases the completion rate of CRC screening in a mailed fecal immunochemical test (FIT) outreach program.
Design, Setting, and Participants


In this randomized clinical quality improvement trial at the University of California, Los Angeles Health of 2339 patients enrolled in a FIT mailing program from August 28, 2019, to September 20, 2020, patients were randomly assigned to either the control or intervention group, and the screening completion rate was measured at 6 months. Participants were average-risk managed care patients aged 50 to 75 years, with a valid mailing address, no mailed CRC outreach in the previous 6 months, and an active electronic health record (EHR) patient portal who were due for CRC screening. Data were analyzed on an intention-to-treat basis.
Interventions


Eligible patients were randomly assigned to receive either (1) the standard FIT mailed outreach (control group) or (2) the standard FIT mailed outreach plus an automated primer to notify patients of the upcoming mailed FIT sent through the electronic patient portal (intervention group).
Main Outcomes and Measures


The primary outcome was the screening completion rate (ie, returning the FIT). Secondary outcomes were (1) were the time to CRC screening from the FIT mailing date, (2) screening modality completed, and (3) the effect of opening the electronic primer on screening completion rate.
Results


The study included 2339 patients (1346 women [57.5%]; mean [SD] age, 58.9 [7.5] years). The screening completion rate was higher in the intervention group than in the control group (37.6% [445 of 1182] vs 32.1% [371 of 1157]; P = .005). The time to screening was shorter in the intervention group than in the control group (adjusted hazard ratio, 1.24; 95% CI, 1.08-1.42; P = .003). The proportion of each screening test modality completed was similar in both groups. In a subanalysis of the 900 of 1182 patients (76.1%) in the intervention group who opened the patient portal primer message, there was a 7.3-percentage point (95% CI, 2.3-12.4 percentage points) increase in CRC screening (local mean treatment effect; P = .004).
Conclusions and Relevance


Implementation of an electronic patient portal primer message in a mailed FIT outreach program led to a significant increase in CRC screening and improvement in the time to screening completion. The findings provide an evidence base for additional refinements to mailed FIT outreach quality improvement programs in large health systems.
Trial Registration


ClinicalTrials.gov Identifier: NCT05115916.",2022,"The time to screening was shorter in the intervention group than in the control group (adjusted hazard ratio, 1.24; 95% CI, 1.08-1.42; P = .003).","['2339 patients (1346 women [57.5%]; mean [SD] age, 58.9 [7.5] years', 'University of California, Los Angeles Health of 2339 patients enrolled in a FIT mailing program from August 28, 2019, to September 20, 2020, patients', 'Interventions\n\n\nEligible patients', 'Participants were average-risk managed care patients aged 50 to 75 years, with a valid mailing address, no mailed CRC outreach in the previous 6 months, and an active electronic health record (EHR) patient portal who were due for CRC screening', 'Colorectal Cancer Screening Rates']","['Patient Portal Messaging Before Mailing Fecal Immunochemical Test Kit', 'standard FIT mailed outreach (control group) or (2) the standard FIT mailed outreach plus an automated primer to notify patients of the upcoming mailed FIT sent through the electronic patient portal (intervention group']","['CRC mortality', 'time to CRC screening from the FIT mailing date, (2) screening modality completed, and (3) the effect of opening the electronic primer on screening completion rate', 'time to screening', 'screening completion rate (ie, returning the FIT', 'CRC screening', 'screening completion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C4277550', 'cui_str': 'Patient Portal'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C4277550', 'cui_str': 'Patient Portal'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0206415', 'cui_str': 'Oligonucleotide Primers'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0206415', 'cui_str': 'Oligonucleotide Primers'}, {'cui': 'C0332156', 'cui_str': 'Return to'}]",2339.0,0.183405,"The time to screening was shorter in the intervention group than in the control group (adjusted hazard ratio, 1.24; 95% CI, 1.08-1.42; P = .003).","[{'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Goshgarian', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Sorourdi', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles.'}, {'ForeName': 'Folasade P', 'Initials': 'FP', 'LastName': 'May', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Vangala', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Meshkat', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Roh', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Han', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Croymans', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.46863']
1860,34954095,Safety and tolerability of hydroxychloroquine in health care workers and first responders for the prevention of COVID-19: WHIP COVID-19 Study.,"BACKGROUND


Health care workers (HCW) are among the highest risk groups for acquisition of COVID-19 because of occupational exposures. The WHIP COVID-19 Study aimed to evaluate the safety and efficacy of hydroxychloroquine (HCQ) as chemoprophylaxis for SARS-CoV-2 infection in this population.
METHODS


HCW, first responders, and other occupationally high-risk participants were enrolled in a randomized, placebo-controlled clinical study of HCQ from April to October 2020. The trial compared daily versus weekly HCQ with placebo and with a prospective cohort on HCQ for autoimmune diseases. Participants were followed for 8 weeks. Serology or a positive polymerase chain reaction test was used to determine laboratory confirmed clinical cases.
RESULTS


A total of 624 participants were randomized to placebo (n = 200), weekly HCQ (n = 201), daily HCQ (n = 197). For the primary safety end point, 279 (44.7%) participants experienced adverse event (AE) level II or lower (total AEs n = 589), similar rates in all randomized groups (P = .188) with no hospitalizations or interventions required. Only 4 laboratory confirmed COVID-19 cases occurred, with 2 in the placebo arm and one in each HCQ randomized arm.
CONCLUSIONS


This randomized placebo-controlled trial was able to demonstrate the safety of HCQ outpatient chemoprophylaxis in high-risk groups against COVID-19. Future studies of chemoprophylaxis for SARS-CoV-2 are needed as the epidemic continues worldwide.",2022,"Only 4 laboratory confirmed COVID-19 cases occurred, with 2 in the placebo arm and one in each HCQ randomized arm.
","['624 participants', 'HCW, first responders, and other occupationally high-risk participants']","['placebo', 'HCQ', 'daily HCQ', 'HCQ with placebo', 'hydroxychloroquine', 'hydroxychloroquine (HCQ']","['Safety and tolerability', 'adverse event (AE) level', 'safety and efficacy']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",624.0,0.492266,"Only 4 laboratory confirmed COVID-19 cases occurred, with 2 in the placebo arm and one in each HCQ randomized arm.
","[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'McKinnon', 'Affiliation': 'Infectious Disease, Henry Ford Hospital, Detroit, Michigan, USA. Electronic address: jmckinn3@hfhs.org.'}, {'ForeName': 'Dee Dee', 'Initials': 'DD', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiovascular Disease, Center for Structural Heart, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Zervos', 'Affiliation': 'Infectious Disease, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Saval', 'Affiliation': 'Division of Cardiovascular Disease, Center for Structural Heart, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Marshall-Nightengale', 'Affiliation': 'Division of Cardiovascular Disease, Center for Structural Heart, Henry Ford Hospital, Detroit, Michigan, USA; Public Health Sciences, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kilgore', 'Affiliation': 'Infectious Disease, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Pardeep', 'Initials': 'P', 'LastName': 'Pabla', 'Affiliation': 'Pharmacy, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Szandzik', 'Affiliation': 'Pharmacy, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Maksimowicz-McKinnon', 'Affiliation': 'Rheumatology, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': ""O'Neill"", 'Affiliation': 'Infectious Disease, Henry Ford Hospital, Detroit, Michigan, USA.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2021.12.343']
1861,35090399,Choice of home blood pressure monitoring device: the role of device characteristics among Alaska Native and American Indian peoples.,"BACKGROUND


Home blood pressure monitoring (HBPM) is an effective tool in treatment and long-term management of hypertension. HBPM incorporates more data points to help patients and providers with diagnosis and management. The characteristics of HBPM devices matter to patients, but the relative importance of the characteristics in choosing a device remains unclear.
METHODS


We used data from a randomized cross-over pilot study with 100 Alaska Native and American Indian (ANAI) people with hypertension to assess the choice of a wrist or arm HBPM device. We use a random utility framework to evaluate the relationship between stated likely use, perceived accuracy, ease of use, comfort, and participant characteristics with choice of device. Additional analyses examined willingness to change to a more accurate device.
RESULTS


Participants ranked the wrist device higher compared to the arm on a 5-point Likert scale for likely use, ease of use, and comfort (0.3, 0.5, 0.8 percentage points, respectively). Most participants (66%) choose the wrist device. Likely use (wrist and arm devices) was related to the probability of choosing the wrist (0.7 and - 1.4 percentage points, respectively). Independent of characteristics, 75% of participants would be willing to use the more accurate device. Ease of use (wrist device) and comfort (arm device) were associated with the probability of changing to a more accurate device (- 1.1 and 0.5 percentage points, respectively).
CONCLUSION


Usability, including comfort, ease, and likely use, appeared to discount the relative importance of perceived accuracy in the device choice. Our results contribute evidence that ANAI populations value accurate HBPM, but that the devices should also be easy to use and comfortable to facilitate long-term management.",2022,"RESULTS


Participants ranked the wrist device higher compared to the arm on a 5-point Likert scale for likely use, ease of use, and comfort (0.3, 0.5, 0.8 percentage points, respectively).","['100 Alaska Native and American Indian (ANAI) people with hypertension to assess the choice of a wrist or arm HBPM device', 'Alaska Native and American Indian peoples']","['Home blood pressure monitoring (HBPM', 'home blood pressure monitoring device', 'HBPM']","['5-point Likert scale for likely use, ease of use, and comfort']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.015541,"RESULTS


Participants ranked the wrist device higher compared to the arm on a 5-point Likert scale for likely use, ease of use, and comfort (0.3, 0.5, 0.8 percentage points, respectively).","[{'ForeName': 'Ashley F', 'Initials': 'AF', 'LastName': 'Railey', 'Affiliation': 'Department of Sociology, Indiana University, Bloomington, IN, USA. arailey@iu.edu.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Dillard', 'Affiliation': 'Southcentral Foundation, Anchorage, AK, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Fyfe-Johnson', 'Affiliation': 'Institute for Research and Education to Advance Community Health (IREACH), Elson S. Floyd College of Medicine, Washington State University, Seattle, WA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'Southcentral Foundation, Anchorage, AK, USA.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Schaefer', 'Affiliation': 'Southcentral Foundation, Anchorage, AK, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rosenman', 'Affiliation': 'Institute for Research and Education to Advance Community Health (IREACH), Elson S. Floyd College of Medicine, Washington State University, Seattle, WA, USA.'}]",BMC cardiovascular disorders,['10.1186/s12872-021-02449-w']
1862,35032696,Randomized trial of fundal height vs point-of-care ultrasound during routine antenatal visits.,,2022,,[],['fundal height vs point-of-care ultrasound'],[],[],"[{'cui': 'C0426012', 'cui_str': 'Height of uterine fundus'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",[],,0.059267,,"[{'ForeName': 'Chasey', 'Initials': 'C', 'LastName': 'Omere', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, 301 University Blvd., Galveston, TX 77555-0587. Electronic address: ciomere@utmb.edu.'}, {'ForeName': 'Daphne Arena', 'Initials': 'DA', 'LastName': 'Goncharov', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, 301 University Blvd., Galveston, TX 77555-0587.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, 301 University Blvd., Galveston, TX 77555-0587.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'La Rosa', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, 301 University Blvd., Galveston, TX 77555-0587.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Munn', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, 301 University Blvd., Galveston, TX 77555-0587.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Chiossi', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, 301 University Blvd., Galveston, TX 77555-0587.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Longo', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, 301 University Blvd., Galveston, TX 77555-0587.'}, {'ForeName': 'Antonio F', 'Initials': 'AF', 'LastName': 'Saad', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, 301 University Blvd., Galveston, TX 77555-0587.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100563']
1863,35104607,High-definition transcranial direct current stimulation modulates eye gaze on emotional faces in college students with alexithymia: An eye-tracking study.,"BACKGROUND


Atypical eye gaze on emotional faces is a core feature of alexithymia. The inferior frontal gyrus (IFG) is considered to be the neurophysiological basis of alexithymia-related emotional face fixation. Our aim was to examine whether anodal high-definition transcranial direct current stimulation (HD-tDCS) administered to the right (r)IFG would facilitate eye gaze of emotional faces in alexithymia individuals.
METHOD


Forty individuals with alexithymia were equally assigned to anodal or sham HD-tDCS of the rIFG according to the principle of randomization. The individuals then completed a free-viewing eye tracking task (including happy, sad, and neutral faces) before and after 5 consecutive days of stimulation (twice a day).
RESULTS


The results showed that twice a day anodal HD-tDCS of the rIFG significantly increased the fixation time and fixation count of the eye area on happy and neutral faces, but there was no significant effect on sad faces. According to the temporal-course analysis, after the intervention, the fixation time on neutral faces increased significantly at almost all time points of the eye tracking task. For happy faces, the improvement was demonstrated between 500 and 1000 ms and between 2500 and 3500 ms. For sad faces, the fixation time improved but not significantly.
CONCLUSIONS


Applying high-dose anodal HD-tDCS to the rIFG selectively facilitated eye gaze in the eye area of neutral and happy faces in individuals with alexithymia, which may improve their face processing patterns.",2022,"For sad faces, the fixation time improved but not significantly.
","['college students with alexithymia', 'alexithymia individuals', 'Forty individuals with alexithymia']","['anodal high-definition transcranial direct current stimulation (HD-tDCS', 'High-definition transcranial direct current stimulation modulates eye gaze', 'right (r)IFG', 'free-viewing eye tracking task (including happy, sad, and neutral faces', 'anodal or sham HD-tDCS of the rIFG']","['fixation time on neutral faces', 'sad faces', 'fixation time', 'fixation time and fixation count of the eye area on happy and neutral faces']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C4505383', 'cui_str': 'Eye Gaze'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152298', 'cui_str': 'Structure of inferior frontal gyrus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}]",40.0,0.0440704,"For sad faces, the fixation time improved but not significantly.
","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei 230032, China; The Second Affiliated Hospital of Anhui Medical University, Hefei, China. Electronic address: zhanglei17236@aliyun.com.'}, {'ForeName': 'Rongrong', 'Initials': 'R', 'LastName': 'Xuan', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Qiuyu', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Zhulin', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Jinmei', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'FengQiong', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Gongjun', 'Initials': 'G', 'LastName': 'Ji', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, The School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei 230032, Anhui Province, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China; Institute of Artificial Intelligence, Hefei Comprehensive National Science Center, Hefei 230088, China. Electronic address: wangkai1964@126.com.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2022.110521']
1864,35112520,Comparison of pramipexole versus ropinirole in the treatment of Parkinson's disease.,"Background and purpose


Parkinson's disease is a progressive neurodegenerative disease characterized by motor and non-motor symptoms. Levodopa is the most effective drug in the symptomatic treatment of the disease. Dopamine receptor agonists provide sustained dopamin-ergic stimulation and have been found to delay the initiation of levodopa treatment and reduce the frequency of various motor complications due to the long-term use of levodopa. The primary aim of this study was to compare the efficacy of potent nonergoline dopamine agonists pramipexole and ropinirole in both ""dopamine agonist monotherapy group"" and ""levodopa add-on therapy group"" in Parkinson's disease. The secondary aims were to evaluate the effects of these agents on depression and the safety of pramipexole and ropinirole.
Methods


A total of 44 patients aged between 36 and 80 years who were presented to the neurology clinic at Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey and were diagnosed with idiopathic Parkinson's disease, were included into this randomized parallel-group clinical study. Dopamine agonist monotherapy and levodopa add-on therapy patients were randomized into two groups to receive either pramipexole or ropinirole. The maximum daily dosages of pramipexole and ropinirole were 4.5 mg and 24 mg respectively. Patients were followed for 6 months and changes on Unified Parkinson's Disease Rating Scale, Clinical Global Impression-severity of illness, Clinical Global Impression-improvement, Beck Depression Inven-tory scores, and additionally in advanced stages, changes in levodopa dosages were evaluated. Drug associated side effects were noted and compared.
Results


In dopamine agonist monotherapy group all of the subsections and total scores of Unified Parkinson's Disease Rating Scale and Clinical Global Impression-severity of illness of the pramipexole subgroup showed significant improvement particularly at the end of the sixth month. In the pramipexole subgroup of levodopa add-on therapy group, there were significant improvements on Clinical Global Impression-severity of illness and Beck Depression Inventory scores, but we found significant improvement on Clinical Global Impression-severity of illness score at the end of the sixth month in ropinirole subgroup too. The efficacy of pramipexole and ropinirole as antiparkinsonian drugs for monotherapy and levodopa add-on therapy in Parkinson's disease and their effects on motor complications when used with levodopa treatment for add-on therapy have been demonstrated in several previous studies.
Conclusion


This study supports the effectiveness and safety of pramipexole and ropinirole in the monotherapy and levodopa add-on therapy in the treatment of Parkinson's disease.",2022,In dopamine agonist monotherapy group all of the subsections and total scores of Unified Parkinson's Disease Rating Scale and Clinical Global Impression-severity of illness of the pramipexole subgroup showed significant improvement particularly at the end of the sixth month.,"[""Parkinson's disease"", ""44 patients aged between 36 and 80 years who were presented to the neurology clinic at Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey and were diagnosed with idiopathic Parkinson's disease""]","['pramipexole and ropinirole', 'nonergoline dopamine agonists pramipexole and ropinirole', 'Levodopa', 'levodopa', 'dopamine agonist monotherapy', 'ropinirole', 'Dopamine agonist monotherapy and levodopa', 'pramipexole', 'pramipexole or ropinirole']","['side effects', ""total scores of Unified Parkinson's Disease Rating Scale and Clinical Global Impression-severity of illness"", 'Clinical Global Impression-severity of illness and Beck Depression Inventory scores', 'Clinical Global Impression-severity of illness score', ""Unified Parkinson's Disease Rating Scale, Clinical Global Impression-severity of illness, Clinical Global Impression-improvement, Beck Depression Inven-tory scores""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0074710', 'cui_str': 'Pramipexole'}, {'cui': 'C0244821', 'cui_str': 'ropinirole'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",44.0,0.067176,In dopamine agonist monotherapy group all of the subsections and total scores of Unified Parkinson's Disease Rating Scale and Clinical Global Impression-severity of illness of the pramipexole subgroup showed significant improvement particularly at the end of the sixth month.,"[{'ForeName': 'Gencler', 'Initials': 'G', 'LastName': 'Serdar Onur', 'Affiliation': 'Department of Neurology, Medical Park Ankara Hospital, Yuksek Ihtisas University, Ankara, Turkey.'}, {'ForeName': 'Nese', 'Initials': 'N', 'LastName': 'Oztekin', 'Affiliation': 'Department of Neurology, Ministry of Health Ankara Numune Training and Research Hospital, University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Mehmet Fevzi', 'Initials': 'MF', 'LastName': 'Oztekin', 'Affiliation': 'Department of Neurology, Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital, University of Health Sciences, Ankara, Turkey.'}]",Ideggyogyaszati szemle,['10.18071/isz.75.0039']
1865,35112504,Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A subgroup analysis by baseline variables in the PIONEER 9 and PIONEER 10 trials.,"AIMS/INTRODUCTION


To assess the impact of baseline characteristics on the efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes.
MATERIALS AND METHODS


In the Peptide InnOvatioN for Early diabEtes tReatment (PIONEER) 9 and 10 trials, Japanese patients were randomized to once-daily oral semaglutide (3, 7, or 14 mg) or a comparator (placebo or once-daily subcutaneous liraglutide 0.9 mg in PIONEER 9; once-weekly subcutaneous dulaglutide 0.75 mg in PIONEER 10) for 52 weeks, with 5 weeks of follow up. An exploratory analysis grouped patients in each trial according to baseline glycated hemoglobin (HbA 1c  ; ≤8.0, >8.0-≤9.0, or >9.0%), body mass index (<25, ≥25-<30, or ≥30 kg/m 2  ) and, for PIONEER 10 only, by background medication (sulfonylurea, glinide, thiazolidinedione, α-glucosidase inhibitor, sodium-glucose cotransporter 2 inhibitor). Efficacy (changes from baseline to week 26 in HbA 1c  and bodyweight) and safety were assessed.
RESULTS


Seven hundred and one patients were included (PIONEER 9: N = 243; PIONEER 10: N = 458). In both trials, HbA 1c  reductions increased as baseline HbA 1c  increased; there were no other apparent patterns between the variables investigated and HbA 1c  or bodyweight changes. There was one statistically significant subgroup interaction between baseline HbA 1c  and estimated treatment differences in bodyweight change for oral semaglutide 14 mg versus placebo in PIONEER 9 (P = 0.0286). Baseline HbA 1c  , baseline body mass index and background medication did not appear to affect the proportions of patients reporting adverse events.
CONCLUSIONS


Oral semaglutide is effective across a range of baseline subgroups of Japanese patients with type 2 diabetes, with no unexpected safety findings.",2022,"In both trials, HbA 1c  reductions increased as baseline HbA 1c  increased; there were no other apparent patterns between the variables investigated and HbA 1c  or body weight changes.","['701 patients were included (PIONEER 9', 'In PIONEER 9 and 10, Japanese patients', 'patients in each trial according to baseline glycated hemoglobin (HbA 1c  ; ≤8.0, >8.0-≤9.0, or >9.0%), body mass index (<25, ≥25-<30, or ≥30 kg/m 2  ), and, for PIONEER 10 only, by background medication (sulfonylurea, glinide, thiazolidinedione, α-glucosidase inhibitor, sodium-glucose cotransporter-2 inhibitor', 'Japanese patients with type 2 diabetes']","['placebo', 'oral semaglutide', 'comparator (placebo or once-daily subcutaneous liraglutide 0.9 mg in PIONEER 9; once-weekly subcutaneous dulaglutide']","['Efficacy and safety', 'HbA 1c  or body weight changes', 'body weight change', 'efficacy and safety', 'Efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C0017764', 'cui_str': 'Glucosidase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",701.0,0.229854,"In both trials, HbA 1c  reductions increased as baseline HbA 1c  increased; there were no other apparent patterns between the variables investigated and HbA 1c  or body weight changes.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yabe', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism and Department of Rheumatology and Clinical Immunology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Deenadayalan', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Horio', 'Affiliation': 'Novo Nordisk Pharma Ltd., Tokyo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kaneto', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Thomas Bo', 'Initials': 'TB', 'LastName': 'Jensen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Terauchi', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Center for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Inagaki', 'Affiliation': 'Department of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13764']
1866,35112416,The first wave of COVID-19 and concurrent social restrictions were not associated with a negative impact on mental health and psychiatric well-being.,"BACKGROUND


The coronavirus disease 2019 (COVID-19) pandemic and efforts to contain it have substantially affected the daily lives of most of the world's population.
OBJECTIVE


We describe the impact of the first COVID-19 wave and associated social restrictions on the mental health of a large adult population.
METHODS


We performed a cohort study nested in a prospective randomized clinical trial, comparing responses during the first COVID-19 wave to previous responses. We calculated the odds ratio (OR) of the population moving up one severity category on validated instruments used to measure stress (PSS-10), anxiety (GAD-7), depression (PHQ-9), and Satisfaction With Life Scale (SWLS). Responses were linked to inpatient and outpatient ICD-10 codes from registries. Models were adjusted for age, sex, comorbidities, and pre-existing diagnoses of mental illness.
RESULTS


Of 63,848 invited participants, 42,253 (66%) responded. The median age was 60 (inter-quartile range 53-68) and 19,032 (45%) were male. Responses during the first wave of COVID-19 did not suggest increased stress (OR 0.97; 95% confidence interval [CI], 0.93-1.01; p = 0.28) or anxiety (OR 1.01; 95% CI, 0.96 to 1.05; p = 0.61), but were associated with decreased depression (OR 0.89; 95% CI, 0.85-0.93, p < 0.0001) and increased satisfaction with life (OR 1.12; 95% CI, 1.08-1.16, p < 0.0001). A secondary analysis of repeated measures data showed similar results.
CONCLUSIONS


Social restrictions were sufficient to contain the pandemic but did not negatively impact validated measures of mental illness or psychiatric well-being. However, responses to individual questions showed signs of fear and stress. This may represent a normal, rather than pathological, population response to a stressful situation.",2022,"CONCLUSIONS


Social restrictions were sufficient to contain the pandemic but did not negatively impact validated measures of mental illness or psychiatric well-being.","['Of 63,848 invited participants 42,253 (66%) responded', 'The median age was 60 (IQR 53-68) and 19,032 (45%) were male']",[],"['stress', 'depression', 'signs of fear and stress', 'odds ratios (OR) of the population moving up one severity category on validated instruments used to measure stress (PSS-10), anxiety (GAD-7), depression (PHQ-9), and satisfaction with life (SWLS', 'satisfaction with life', 'anxiety']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",63848.0,0.0365186,"CONCLUSIONS


Social restrictions were sufficient to contain the pandemic but did not negatively impact validated measures of mental illness or psychiatric well-being.","[{'ForeName': 'Thorvardur Jon', 'Initials': 'TJ', 'LastName': 'Love', 'Affiliation': 'Faculty of Medicine, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Wessman', 'Affiliation': 'Faculty of Psychology, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Gauti Kjartan', 'Initials': 'GK', 'LastName': 'Gislason', 'Affiliation': 'Faculty of Medicine, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Saemundur', 'Initials': 'S', 'LastName': 'Rognvaldsson', 'Affiliation': 'Faculty of Medicine, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Thorsteinsdottir', 'Affiliation': 'Faculty of Medicine, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Gudrun Asta', 'Initials': 'GA', 'LastName': 'Sigurdardottir', 'Affiliation': 'Faculty of Medicine, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Asdis Rosa', 'Initials': 'AR', 'LastName': 'Thordardottir', 'Affiliation': 'Faculty of Medicine, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Eythorsson', 'Affiliation': 'Department of Medicine, Landspitali University Hospital, Reykjavik, Iceland.'}, {'ForeName': 'Tinna Laufey', 'Initials': 'TL', 'LastName': 'Asgeirsdottir', 'Affiliation': 'Faculty of Economics, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Aspelund', 'Affiliation': 'Centre for Public Health Sciences, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Andri Steinthor', 'Initials': 'AS', 'LastName': 'Bjornsson', 'Affiliation': 'Faculty of Psychology, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Sigurdur Yngvi', 'Initials': 'SY', 'LastName': 'Kristinsson', 'Affiliation': 'Faculty of Medicine, University of Iceland, Reykjavik, Iceland.'}]",Journal of internal medicine,['10.1111/joim.13461']
1867,35100190,Transfusion-Associated Delirium in Children: No Difference Between Short Storage Versus Standard Issue RBCs.,"OBJECTIVES


Primary objective is to determine if transfusion of short storage RBCs compared with standard issue RBCs reduced risk of delirium/coma in critically ill children. Secondary objective is to assess if RBC transfusion was independently associated with delirium/coma.
DESIGN


This study was performed in two stages. First, we compared patients receiving either short storage or standard RBCs in a multi-institutional prospective randomized controlled trial. Then, we compared all transfused patients in the randomized controlled trial with a single-center cohort of nontransfused patients matched for confounders of delirium/coma.
SETTING


Twenty academic PICUs who participated in the Age of Transfused Blood in Critically Ill Children trial.
PATIENTS


Children 3 days to 16 years old who were transfused RBCs within the first 7 days of admission.
INTERVENTIONS


Subjects were randomized to either short storage RBC study arm (defined as RBCs stored for up to seven days) or standard issue RBC study arm. In addition, subjects were screened for delirium prior to transfusion and every 12 hours after transfusion for up to 3 days.
MEASUREMENTS AND MAIN RESULTS


Primary outcome measure was development of delirium/coma within 3 days of initial transfusion. Additional outcome measures were dose-response relationship between volume of RBCs transfused and delirium/coma, and comparison of delirium/coma rates between transfused patients and individually matched nontransfused patients. We included 146 subjects in the stage I analysis; 69 were randomized to short storage RBCs and 77 to standard issue. There was no significant difference in delirium/coma development between study arms (79.5% vs 70.1%; p = 0.184). In the stage II analysis, adjusted odds for delirium in the transfused cohort was more than eight-fold higher than in the nontransfused matched cohort, even after controlling for hemoglobin (adjusted odds ratio, 8.9; CI, 2.8-28.4; p < 0.001).
CONCLUSIONS


RBC transfusions (and not anemia) are independently associated with increased odds of subsequent delirium/coma. However, storage age of RBCs does not affect delirium risk.",2022,There was no significant difference in delirium/coma development between study arms (79.5% vs 70.1%; p = 0.184).,"['Children', 'critically ill children', 'Children 3 days to 16 years old who were transfused RBCs within the first 7 days of admission', '146 subjects in the stage I analysis; 69 were randomized to', 'Twenty academic PICUs who participated in the Age of Transfused Blood in Critically Ill Children trial']","['short storage or standard RBCs', 'short storage RBCs', 'short storage RBC']","['RBC transfusion', 'delirium/coma development', 'development of delirium/coma within 3 days of initial transfusion', 'dose-response relationship between volume of RBCs transfused and delirium/coma, and comparison of delirium/coma rates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}]",146.0,0.16959,There was no significant difference in delirium/coma development between study arms (79.5% vs 70.1%; p = 0.184).,"[{'ForeName': 'Chani', 'Initials': 'C', 'LastName': 'Traube', 'Affiliation': 'Division of Critical Care Medicine, Department of Pediatrics, Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Tucci', 'Affiliation': 'Department of Pediatrics, CHU Sainte-Justine, University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Marianne E', 'Initials': 'ME', 'LastName': 'Nellis', 'Affiliation': 'Division of Critical Care Medicine, Department of Pediatrics, Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'K Leslie', 'Initials': 'KL', 'LastName': 'Avery', 'Affiliation': 'Department of Pediatrics, University of Florida College of Medicine, Gainesville, FL.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'McQuillen', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Muszynski', 'Affiliation': ""Division of Critical Care Medicine, Department of Pediatrics, Nationwide Children's Hospital, Columbus, OH.""}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Cholette', 'Affiliation': ""Department of Pediatrics, University of Rochester, Golisano Children's Hospital, Rochester, NY.""}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Schwarz', 'Affiliation': ""Critical Care, CHOC Children's Hospital, Orange, CA.""}, {'ForeName': 'Erika L', 'Initials': 'EL', 'LastName': 'Stalets', 'Affiliation': ""Division of Critical Care Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Quaid', 'Affiliation': ""Department of Pediatrics, Advocate Children's Hospital, Park Ridge, IL.""}, {'ForeName': 'Sheila J', 'Initials': 'SJ', 'LastName': 'Hanson', 'Affiliation': ""Department of Pediatrics and Children's Wisconsin, Critical Care Section, Medical College of Wisconsin, Milwaukee, WI.""}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Lacroix', 'Affiliation': 'Division of Pediatric Critical Care, Department of Pediatrics, CHU Sainte-Justine, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Ron W', 'Initials': 'RW', 'LastName': 'Reeder', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Spinella', 'Affiliation': 'Division of Critical Care Medicine, Department of Pediatrics, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000005393']
1868,35105053,A listening experiment comparing the timbre of two Stradivari with other violins.,"The violins of Stradivari are recognized worldwide as an excellence in craftsmanship, a model for instrument makers, and an unachievable desire for collectors and players. However, despite the myth surrounding these instruments, blindfolded players tendentially prefer to play modern violins. Here, we present a double blind listening experiment aimed at analyzing and comparatively rating the sound timbre of violins. The mythic instruments were listened to among other well regarded and not so well regarded violins. 70 listeners (violin makers of the Cremona area) rated the timbre difference between the simple musical scales played on a test and a reference violin, and the results showed that their preference converged on one particular Stradivari. The acoustical measurements revealed some similarities between the subjective ratings and the physical characteristics of the violins. It is speculated that the myth of Stradivari could have been boosted, among other factors, by the specimens of tonal superior quality, which biased favourably the judgment on his instruments and spread on all of the maker's production. These results contribute to the understanding of the timbre of violins and suggest the characteristics that are in a relationship with the pleasantness of the timbre.",2022,"70 listeners (violin makers of the Cremona area) rated the timbre difference between the simple musical scales played on a test and a reference violin, and the results showed that their preference converged on one particular Stradivari.",['70 listeners (violin makers of the Cremona area'],[],[],"[{'cui': 'C0554244', 'cui_str': 'Maker'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",[],[],,0.0856646,"70 listeners (violin makers of the Cremona area) rated the timbre difference between the simple musical scales played on a test and a reference violin, and the results showed that their preference converged on one particular Stradivari.","[{'ForeName': 'Carlo Andrea', 'Initials': 'CA', 'LastName': 'Rozzi', 'Affiliation': 'Consiglio Nazionale delle Ricerche, Istituto Nanoscienze, Modena, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Voltini', 'Affiliation': 'Cremona International Violin Making School ""A. Stradivari,"" Cremona, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Antonacci', 'Affiliation': 'Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milano, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Nucci', 'Affiliation': 'Dipartimento di Psicologia Generale, Università di Padova, Padova, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Grassi', 'Affiliation': 'Dipartimento di Psicologia Generale, Università di Padova, Padova, Italy.'}]",The Journal of the Acoustical Society of America,['10.1121/10.0009320']
1869,35105443,Effect of endometrial scratching on unassisted conception for unexplained infertility: a randomized controlled trial.,"OBJECTIVE


To investigate whether endometrial scratching increases the chance of live birth in women with unexplained infertility attempting to conceive without assisted reproductive technology.
DESIGN


Randomized, placebo-controlled, participant-blind, multicenter international trial.
SETTING


Fertility clinics.
PATIENT(S)


Women with a diagnosis of unexplained infertility trying to conceive without assistance.
INTERVENTION(S)


Participants were randomly assigned to receive an endometrial biopsy or a placebo procedure (placement of a biopsy catheter in the posterior fornix, without inserting it into the external cervical os). Both groups performed regular unprotected intercourse with the intention of conceiving over three consecutive study cycles.
MAIN OUTCOME MEASURE(S)


The primary outcome was live birth.
RESULT(S)


A total of 220 women underwent randomization. The live birth rate was 9% (10 of 113 women) in the endometrial-scratch group and 7% (7 of 107 women) in the control group (adjusted OR, 1.39; 95% CI, 0.50-4.03). There were no differences between the groups in the secondary outcomes of clinical pregnancy, viable pregnancy, ongoing pregnancy, and miscarriage. Endometrial scratching was associated with a higher pain score on a 10-point scale (adjusted mean difference, 3.07; 95% CI, 2.53-3.60).
CONCLUSION(S)


This trial did not find evidence that endometrial scratching improves the live birth rate in women with unexplained infertility trying to conceive without assistance.
CLINICAL TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry ACTRN12614000656639.",2022,"There were no differences between the groups in the secondary outcomes of clinical pregnancy, viable pregnancy, ongoing pregnancy, and miscarriage.","['women with unexplained infertility attempting to conceive without assisted reproductive technology', '220 women underwent randomization', 'women with unexplained infertility', 'Fertility clinics', 'unexplained infertility', '\n\n\nWomen with a diagnosis of unexplained infertility trying to conceive without assistance']","['placebo', 'endometrial biopsy or a placebo procedure (placement of a biopsy catheter', 'endometrial scratching']","['clinical pregnancy, viable pregnancy, ongoing pregnancy, and miscarriage', 'live birth', 'live birth rate', 'chance of live birth', 'higher pain score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}, {'cui': 'C0035157', 'cui_str': 'Reproductive Technologies'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4760630', 'cui_str': 'Infertility Clinics'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0420843', 'cui_str': 'Trying to conceive'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C4049214', 'cui_str': 'Endometrial scratching'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0404843', 'cui_str': 'Viable pregnancy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",220.0,0.83734,"There were no differences between the groups in the secondary outcomes of clinical pregnancy, viable pregnancy, ongoing pregnancy, and miscarriage.","[{'ForeName': 'Tze Yoong', 'Initials': 'TY', 'LastName': 'Wong', 'Affiliation': 'Fertility Plus, Greenlane Clinical Centre, Auckland 1051, New Zealand; Repromed, Auckland, New Zealand. Electronic address: tzeywong@gmail.com.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lensen', 'Affiliation': ""Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia; Department of Obstetrics and Gynaecology, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.""}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Wilkinson', 'Affiliation': 'Centre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Elizabeth Joan', 'Initials': 'EJ', 'LastName': 'Glanville', 'Affiliation': 'Fertility Plus, Greenlane Clinical Centre, Auckland 1051, New Zealand.'}, {'ForeName': 'Santanu', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': 'Ayrshire Fertility Unit, University Hospital Crosshouse, Ayrshire and Arran, Kilmarnock, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Clarke', 'Affiliation': 'East Lancashire NHS Teaching Hospitals Trust, Burnley General Hospital, Burnley, United Kingdom.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Obstetrics and Gynaecology, Bolton NHS Foundation Trust, Bolton, United Kingdom.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Dawson', 'Affiliation': 'Derby Fertility Unit, Royal Derby Hospital, Derby, United Kingdom.'}, {'ForeName': 'Bev', 'Initials': 'B', 'LastName': 'Hammond', 'Affiliation': 'East Lancashire NHS Teaching Hospitals Trust, Burnley General Hospital, Burnley, United Kingdom.'}, {'ForeName': 'Kanna', 'Initials': 'K', 'LastName': 'Jayaprakasan', 'Affiliation': 'Derby Fertility Unit, Royal Derby Hospital, Derby, United Kingdom.'}, {'ForeName': 'Nichola', 'Initials': 'N', 'LastName': 'Kearsley', 'Affiliation': 'Countess of Chester Hospital NHS Foundation Trust, Chester, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Milner', 'Affiliation': 'East Lancashire NHS Teaching Hospitals Trust, Burnley General Hospital, Burnley, United Kingdom.'}, {'ForeName': 'Nethra', 'Initials': 'N', 'LastName': 'Shankaralingaiah', 'Affiliation': 'East Lancashire NHS Teaching Hospitals Trust, Burnley General Hospital, Burnley, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Wood', 'Affiliation': 'Countess of Chester Hospital NHS Foundation Trust, Chester, United Kingdom.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Sadler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Farquhar', 'Affiliation': 'Fertility Plus, Greenlane Clinical Centre, Auckland 1051, New Zealand; Department of Obstetrics and Gynaecology, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}]",Fertility and sterility,['10.1016/j.fertnstert.2021.12.009']
1870,35107504,LIECHTENSTEIN VERSUS LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) HERNIA REPAIR: A PROSPECTIVE COMPARATIVE STUDY FOCUSED ON POSTOPERATIVE OUTCOMES IN A GENERAL SURGERY UNIT.,"AIM


Three surgical techniques for inguinal hernia repair are currently validated. Few studies have compared results among Lichtenstein and transabdominal preperitoneal (TAPP) laparoscopic approach obtained at an early step of the learning curve. This study aims to compare the early treatment results between the Liechtenstein technique and the laparoscopic TAPP approach to provide a basis for the surgeon's decision-making.
METHODS


Patients were divided into two groups: those who underwent laparoscopic TAPP approach (114 patients), and those who underwent open Lichtenstein repair (35 patients). Data were collected from the medical records during the evolution of the immediate postoperative period and by telephone contact after hospital discharge. For the analysis of the variables, the chi-square test of independence was implemented, with a level of significance set at a p-value of 0.05.
RESULTS


There was a strong association between laparoscopy, less postoperative pain, and longer operative time. In addition, a preference for the technique in cases of recurrence, bilaterality, associated umbilical hernia, or obesity was noticed. In this study, the Lichtenstein technique was associated with a shorter time to return to work and was the treatment of choice for elderly patients.
CONCLUSION


TAPP laparoscopic herniorrhaphy should be the first choice in cases of bilaterality, associated umbilical hernia, obesity, and recurrence to a previous anterior repair. The surgical risk is adequate for the procedure, even at early stages of the learning curve.",2022,"There was a strong association between laparoscopy, less postoperative pain, and longer operative time.","['elderly patients', 'Patients were divided into two groups: those who underwent', '35 patients', 'inguinal hernia repair']","['LIECHTENSTEIN VERSUS LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP', 'open Lichtenstein repair', 'Lichtenstein and transabdominal preperitoneal (TAPP) laparoscopic approach', 'TAPP laparoscopic herniorrhaphy', 'HERNIA REPAIR', 'laparoscopic TAPP approach', 'Liechtenstein technique and the laparoscopic TAPP approach']","['postoperative pain, and longer operative time', 'recurrence, bilaterality, associated umbilical hernia, or obesity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}]","[{'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0019322', 'cui_str': 'Umbilical hernia'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",114.0,0.0432163,"There was a strong association between laparoscopy, less postoperative pain, and longer operative time.","[{'ForeName': 'Carlos Augusto', 'Initials': 'CA', 'LastName': 'Gomes', 'Affiliation': 'Hospital e Maternidade Therezinha de Jesus, Unidade de Cirurgia Digestiva - Juiz de Fora - Minas Gerais - Brasil.'}, {'ForeName': 'Felipe Couto', 'Initials': 'FC', 'LastName': 'Gomes', 'Affiliation': 'Hospital e Maternidade Therezinha de Jesus, Unidade de Cirurgia Digestiva - Juiz de Fora - Minas Gerais - Brasil.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Podda', 'Affiliation': 'University Hospital of Cagliari, Emergency Surgery - Cagliari - Sardinia - Itália.'}, {'ForeName': 'Ana Paula Fernandes', 'Initials': 'APF', 'LastName': 'Braga', 'Affiliation': 'Hospital de Clínicas da Unversidade Federal do Triângulo Mineiro, Unidade de Coloproctologia - Uberaba - Minas Gerais - Brasil.'}, {'ForeName': 'Sarah Carvalho', 'Initials': 'SC', 'LastName': 'Ribeiro', 'Affiliation': 'Faculdade de Ciências Médicas e da Saúde (FCMS/JF) - SUPREMA, Medicina - Juiz de Fora - Minas Gerais - Brasil.'}, {'ForeName': 'Larissa Fahel', 'Initials': 'LF', 'LastName': 'Vaz', 'Affiliation': 'Faculdade de Ciências Médicas e da Saúde (FCMS/JF) - SUPREMA, Medicina - Juiz de Fora - Minas Gerais - Brasil.'}]",Arquivos brasileiros de cirurgia digestiva : ABCD = Brazilian archives of digestive surgery,['10.1590/0102-672020210002e1642']
1871,35107493,TECHNIQUE OF EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION OBTAINED BY THE FLEXIBLE LIVER RETRACTOR IN BARIATRIC SURGERY: A RANDOMIZED CONTROLLED TRIAL.,"AIM


In the Roux-en-Y gastric bypass technique, classic laparoscopic surgical retractors are usually rigid, require an additional incision for its installation, or must be handled by an assistant during the surgical procedure, involving a risk of liver injury. The aim of this study was to evaluate and validate a technique of the esophagogastric junction exposure obtained by the flexible liver retractor in bariatric surgery, comparing its efficacy with the retractor classically used for this purpose.
METHODS


This study was performed as a randomized, open, prospective, controlled, and comparative design in patients with medical indications of bariatric surgery. The subjects were distributed in the classic (control) and flexible (test) retractor groups.
RESULTS


A total of 100 patients (n=50 control group, n=50 test group) were included. No statistically significant difference was observed in the mean duration of surgery. Regarding visibility, 100% of the patients in the flexible retractor group demonstrated an optimal visibility level, although without statistical significance concerning the classic retractor group (94%). Invariably, carrying a trocar was necessary when using the classic retractor.
CONCLUSIONS


The flexible liver retractor is safe, effective, ergonomic, and inexpensive. Furthermore, it presented a satisfactory aesthetic profile, and the use of specific instruments, new adaptation curve, and training for its handling were not required.",2022,"Regarding visibility, 100% of the patients in the flexible retractor group demonstrated an optimal visibility level, although without statistical significance concerning the classic retractor group (94%).","['patients with medical indications of bariatric surgery', '100 patients (n=50 control group, n=50 test group) were included']","['Roux-en-Y gastric bypass technique, classic laparoscopic surgical retractors']","['optimal visibility level', 'mean duration of surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0183014', 'cui_str': 'Retractor'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",100.0,0.0291091,"Regarding visibility, 100% of the patients in the flexible retractor group demonstrated an optimal visibility level, although without statistical significance concerning the classic retractor group (94%).","[{'ForeName': 'Rodrigo Feitosa de Albuquerque Lima', 'Initials': 'RFAL', 'LastName': 'Babadopulos', 'Affiliation': 'Unidade de Cirurgia Bariátrica, Hospital Geral Dr. César Cals, Fortaleza, CE, Brasil.'}, {'ForeName': 'Luiz Gonzaga de', 'Initials': 'LG', 'LastName': 'Moura-Jr', 'Affiliation': 'Unidade de Cirurgia Bariátrica, Hospital Geral Dr. César Cals, Fortaleza, CE, Brasil.'}, {'ForeName': 'Vagnaldo', 'Initials': 'V', 'LastName': 'Fechine', 'Affiliation': 'Centro de Pesquisa e Desenvolvimento de Medicamentos, Unidade de Farmacologia Clínica, Universidade Federal do Ceará, Fortaleza, CE, Brasil.'}, {'ForeName': 'Marina Becker Sales', 'Initials': 'MBS', 'LastName': 'Rocha', 'Affiliation': 'Centro de Pesquisa e Desenvolvimento de Medicamentos, Unidade de Farmacologia Clínica, Universidade Federal do Ceará, Fortaleza, CE, Brasil.'}, {'ForeName': 'Natalícia', 'Initials': 'N', 'LastName': 'Antunes', 'Affiliation': 'Departamento de Farmacologia, Faculdade de Ciências Médicas, Universidade Estadual de Campinas - Unicamp, Campinas, São Paulo - SP, Brasil.'}, {'ForeName': 'Thomaz Alexandre', 'Initials': 'TA', 'LastName': 'Costa', 'Affiliation': 'Centro de Pesquisa e Desenvolvimento de Medicamentos, Unidade de Farmacologia Clínica, Universidade Federal do Ceará, Fortaleza, CE, Brasil.'}, {'ForeName': 'Bruno Almeida', 'Initials': 'BA', 'LastName': 'Costa', 'Affiliation': 'Centro de Pesquisa e Desenvolvimento de Medicamentos, Unidade de Farmacologia Clínica, Universidade Federal do Ceará, Fortaleza, CE, Brasil.'}, {'ForeName': 'Manoel Odorico', 'Initials': 'MO', 'LastName': 'DE-Moraes', 'Affiliation': 'Centro de Pesquisa e Desenvolvimento de Medicamentos, Unidade de Farmacologia Clínica, Universidade Federal do Ceará, Fortaleza, CE, Brasil.'}]",Arquivos brasileiros de cirurgia digestiva : ABCD = Brazilian archives of digestive surgery,['10.1590/0102-672020210002e1631']
1872,35113805,Oral 11β-HSD1 inhibitor AZD4017 improves wound healing and skin integrity in adults with type 2 diabetes mellitus: a pilot randomized controlled trial.,"Background


Chronic wounds (e.g. diabetic foot ulcers) reduce the quality of life, yet treatments remain limited. Glucocorticoids (activated by the enzyme 11β-hydroxysteroid dehydrogenase type 1, 11β-HSD1) impair wound healing.
Objectives


Efficacy, safety, and feasibility of 11β-HSD1 inhibition for skin function and wound healing.
Design


Investigator-initiated, double-blind, randomized, placebo-controlled, parallel-group phase 2b pilot trial.
Methods


Single-center secondary care setting. Adults with type 2 diabetes mellitus without foot ulcers were administered 400 mg oral 11β-HSD1 inhibitor AZD4017 (n = 14) or placebo (n = 14) bi-daily for 35 days. Participants underwent 3-mm full-thickness punch skin biopsies at baseline and on day 28; wound healing was monitored after 2 and 7 days. Computer-generated 1:1 randomization was pharmacy-administered. Analysis was descriptive and focused on CI estimation. Of the 36 participants screened, 28 were randomized.
Results


Exploratory proof-of-concept efficacy analysis suggested AZD4017 did not inhibit 24-h ex vivoskin 11β-HSD1 activity (primary outcome; difference in percentage conversion per 24 h 1.1% (90% CI: -3.4 to 5.5) but reduced systemic 11β-HSD1 activity by 87% (69-104%). Wound diameter was 34% (7-63%) smaller with AZD4017 at day 2, and 48% (12-85%) smaller after repeat wounding at day 30. AZD4017 improved epidermal integrity but modestly impaired barrier function. Minimal adverse events were comparable to placebo. Recruitment rate, retention, and data completeness were 2.9/month, 27/28, and 95.3%, respectively.
Conclusion


A phase 2 trial is feasible, and preliminary proof-of-concept data suggests AZD4017 warrants further investigation in conditions of delayed healing, for example in diabetic foot ulcers.
Significance statement


Stress hormone activation by the enzyme 11β-HSD type 1 impairs skin function (e.g. integrity) and delays wound healing in animal models of diabetes, but effects in human skin were previously unknown. Skin function was evaluated in response to treatment with a 11β-HSD type 1 inhibitor (AZD4017), or placebo, in people with type 2 diabetes. Importantly, AZD4017 was safe and well tolerated. This first-in-human randomized, controlled, clinical trial found novel evidence that 11β-HSD type 1 regulates skin function in humans, including improved wound healing, epidermal integrity, and increased water loss. Results warrant further studies in conditions of impaired wound healing, for example, diabetic foot ulcers to evaluate 11β-HSD type 1 as a novel therapeutic target forchronic wounds.",2022,"Wound diameter was 34% (7-63%) smaller with AZD4017 at day 2, and 48% (12-85%) smaller after repeat wounding at day 30.","['adults with type 2 diabetes mellitus', 'Participants underwent 3 mm', 'Single-center secondary care setting', 'Adults with type 2 diabetes mellitus without foot ulcers', '36 participants screened, 28 were randomized']","['placebo', 'Glucocorticoids', 'Oral 11β-HSD1 inhibitor AZD4017', 'oral 11β-HSD1 inhibitor AZD4017 (n=14) or placebo', '11β-HSD1 inhibition']","['Recruitment rate, retention and data completeness', 'systemic 11β-HSD1 activity', 'barrier function', 'full-thickness punch skin biopsies', 'wound healing', 'ex vivo skin 11β-HSD1 activity', 'skin function and wound healing', 'Minimal adverse events', 'Wound diameter', 'wound healing and skin integrity', 'epidermal integrity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0085119', 'cui_str': 'Ulcer of foot'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3501337', 'cui_str': 'AZD4017'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439809', 'cui_str': 'Full thickness'}, {'cui': 'C0191321', 'cui_str': 'Punch biopsy of skin'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0037289', 'cui_str': 'Skin function'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1286235', 'cui_str': 'Integrity of skin'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0205266', 'cui_str': 'Intact'}]",28.0,0.355986,"Wound diameter was 34% (7-63%) smaller with AZD4017 at day 2, and 48% (12-85%) smaller after repeat wounding at day 30.","[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Ajjan', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'E M A', 'Initials': 'EMA', 'LastName': 'Hensor', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Del Galdo', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shams', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abbas', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Fairclough', 'Affiliation': 'Emerging Innovations Unit, Discovery Sciences, BioPharmaceuticals R&D.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': 'Emerging Portfolio Development, Late Oncology, Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pegg', 'Affiliation': 'Emerging Portfolio Development, Late Oncology, Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Freeman', 'Affiliation': 'Emerging Innovations Unit, Discovery Sciences, BioPharmaceuticals R&D.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Taylor', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Arlt', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Morgan', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Tahrani', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Stewart', 'Affiliation': 'NIHR Leeds Biomedical Research Center, Leeds Teaching Hospitals, NHS Trust, Leeds, UK.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Russell', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tiganescu', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}]",European journal of endocrinology,['10.1530/EJE-21-1197']
1873,35119463,Effect of Clinical Decision Support at Community Health Centers on the Risk of Cardiovascular Disease: A Cluster Randomized Clinical Trial.,"Importance


Management of cardiovascular disease (CVD) risk in socioeconomically vulnerable patients is suboptimal; better risk factor control could improve CVD outcomes.
Objective


To evaluate the impact of a clinical decision support system (CDSS) targeting CVD risk in community health centers (CHCs).
Design, Setting, and Participants


This cluster randomized clinical trial included 70 CHC clinics randomized to an intervention group (42 clinics; 8 organizations) or a control group that received no intervention (28 clinics; 7 organizations) from September 20, 2018, to March 15, 2020. Randomization was by CHC organization accounting for organization size. Patients aged 40 to 75 years with (1) diabetes or atherosclerotic CVD and at least 1 uncontrolled major risk factor for CVD or (2) total reversible CVD risk of at least 10% were the population targeted by the CDSS intervention.
Interventions


A point-of-care CDSS displaying real-time CVD risk factor control data and personalized, prioritized evidence-based care recommendations.
Main Outcomes and Measures


One-year change in total CVD risk and reversible CVD risk (ie, the reduction in 10-year CVD risk that was considered achievable if 6 key risk factors reached evidence-based levels of control).
Results


Among the 18 578 eligible patients (9490 [51.1%] women; mean [SD] age, 58.7 [8.8] years), patients seen in control clinics (n = 7419) had higher mean (SD) baseline CVD risk (16.6% [12.8%]) than patients seen in intervention clinics (n = 11 159) (15.6% [12.3%]; P < .001); baseline reversible CVD risk was similarly higher among patients seen in control clinics. The CDSS was used at 19.8% of 91 988 eligible intervention clinic encounters. No population-level reduction in CVD risk was seen in patients in control or intervention clinics; mean reversible risk improved significantly more among patients in control (-0.1% [95% CI, -0.3% to -0.02%]) than intervention clinics (0.4% [95% CI, 0.3% to 0.5%]; P < .001). However, when the CDSS was used, both risk measures decreased more among patients with high baseline risk in intervention than control clinics; notably, mean reversible risk decreased by an absolute 4.4% (95% CI, -5.2% to -3.7%) among patients in intervention clinics compared with 2.7% (95% CI, -3.4% to -1.9%) among patients in control clinics (P = .001).
Conclusions and Relevance


The CDSS had low use rates and failed to improve CVD risk in the overall population but appeared to have a benefit on CVD risk when it was consistently used for patients with high baseline risk treated in CHCs. Despite some limitations, these results provide preliminary evidence that this technology has the potential to improve clinical care in socioeconomically vulnerable patients with high CVD risk.
Trial Registration


ClinicalTrials.gov Identifier: NCT03001713.",2022,"No population-level reduction in CVD risk was seen in patients in control or intervention clinics; mean reversible risk improved significantly more among patients in control (-0.1% [95% CI, -0.3% to -0.02%]) than intervention clinics (0.4% [95% CI, 0.3% to 0.5%]; P < .001).","['patients with high baseline risk treated in CHCs', 'community health centers (CHCs', 'Patients aged 40 to 75 years with (1) diabetes or atherosclerotic CVD and at least 1 uncontrolled major risk factor for CVD or (2) total reversible CVD risk of at least 10% were the population targeted by the CDSS intervention', 'socioeconomically vulnerable patients', 'socioeconomically vulnerable patients with high CVD risk']","['clinical decision support system (CDSS', 'control group that received no intervention']","['higher mean (SD) baseline CVD risk', 'mean reversible risk', 'CVD risk', 'baseline reversible CVD risk', 'reversible risk', 'Measures\n\n\nOne-year change in total CVD risk and reversible CVD risk (ie, the reduction in 10-year CVD risk', 'Risk of Cardiovascular Disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0039309', 'cui_str': 'Target Population'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439234', 'cui_str': 'year'}]",70.0,0.17763,"No population-level reduction in CVD risk was seen in patients in control or intervention clinics; mean reversible risk improved significantly more among patients in control (-0.1% [95% CI, -0.3% to -0.02%]) than intervention clinics (0.4% [95% CI, 0.3% to 0.5%]; P < .001).","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Gold', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Annie E', 'Initials': 'AE', 'LastName': 'Larson', 'Affiliation': 'OCHIN Inc, Portland, Oregon.'}, {'ForeName': 'JoAnn M', 'Initials': 'JM', 'LastName': 'Sperl-Hillen', 'Affiliation': 'HealthPartners Institute, Minneapolis, Minnesota.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Boston', 'Affiliation': 'OCHIN Inc, Portland, Oregon.'}, {'ForeName': 'Christina R', 'Initials': 'CR', 'LastName': 'Sheppler', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Heintzman', 'Affiliation': 'OCHIN Inc, Portland, Oregon.'}, {'ForeName': 'Carmit', 'Initials': 'C', 'LastName': 'McMullen', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Middendorf', 'Affiliation': 'OCHIN Inc, Portland, Oregon.'}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Appana', 'Affiliation': 'HealthPartners Institute, Minneapolis, Minnesota.'}, {'ForeName': 'Vijayakumar', 'Initials': 'V', 'LastName': 'Thirumalai', 'Affiliation': 'HealthPartners Institute, Minneapolis, Minnesota.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Romer', 'Affiliation': 'OCHIN Inc, Portland, Oregon.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Bava', 'Affiliation': 'OCHIN Inc, Portland, Oregon.'}, {'ForeName': 'James V', 'Initials': 'JV', 'LastName': 'Davis', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Yosuf', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hauschildt', 'Affiliation': 'OCHIN Inc, Portland, Oregon.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Scott', 'Affiliation': 'OCHIN Inc, Portland, Oregon.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Moore', 'Affiliation': 'OCHIN Inc, Portland, Oregon.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'HealthPartners Institute, Minneapolis, Minnesota.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.46519']
1874,35119460,Effect of Exposure to Visual Campaigns and Narrative Vignettes on Addiction Stigma Among Health Care Professionals: A Randomized Clinical Trial.,"Importance


Stigma toward people with opioid use disorder (OUD) is pervasive in clinical settings, impeding delivery of high-quality care. To date, no study has evaluated the effect of different stigma-reduction messages or messengers among health care professionals.
Objective


To evaluate the effect of OUD-related messages delivered by different messengers on stigma and attitudes toward people with OUD among health care professionals.
Design, Setting, and Participants


This randomized clinical trial examined the effects of OUD-related messages delivered by a visual campaign alone or in combination with a written narrative vignette from the perspective of 1 of 3 messengers. Health care professionals in the US were recruited from 2 national online survey panels (Ipsos KnowledgePanel and SurveyHealthcareGlobus). A total of 1842 participants completed a web-based survey measuring stigma toward people with OUD from November 13 to 30, 2020.
Interventions


Eight groups were exposed to 1 of 2 message frames. One frame (Words Matter) emphasized the harm of stigmatizing language, and the other (Medication Treatment Works) focused on the effectiveness of medications approved by the US Food and Drug Administration for the treatment of OUD. Message frames were communicated through either a visual campaign alone or a visual campaign in combination with a written narrative vignette from the perspective of a simulated patient with OUD, a clinician, or a health care system administrator.
Main Outcomes and Measures


Dimensions of stigma toward people with OUD were measured on 5-point Likert scales that included items about desire for social distance from people with OUD, perception of individual blame for OUD, perspective of OUD as a medical condition, and support for increased governmental spending on OUD treatment. The level of warmth felt toward people with OUD was measured by a feeling thermometer (range, 0-100 points).
Results


Among 1842 participants, the mean (SD) age was 47 (13) years; 1324 participants (71.9%) were female, 145 (7.9%) were Hispanic, 140 (7.6%) were non-Hispanic Black, 1344 (73.0%) were non-Hispanic White, and 213 (11.6%) were of other non-Hispanic race (ie, individuals who did not self-report race as Black or White and did not self-report ethnicity as Hispanic). Compared with nonexposure, exposure to the combination of visual campaign and narrative vignette communicating the importance of nonstigmatizing language from the perspective of a patient with OUD was associated with a lower probability (difference, -16.8 percentage points, 95% CI, -26.1 to -7.4; P < .001) of unwillingness to have a person with OUD marry into the family (a measure of social distance preference) and a 7.2-point (95% CI, 3.2-11.1; P < .001) higher warmth rating. Participants exposed to the combined visual campaign and patient vignette about the value of medication treatment for OUD also had significantly lower levels of stigma compared with those in the nonexposed control group (eg, unwillingness to have a person with OUD as a neighbor: difference, -15.3 percentage points; 95% CI, -24.6 to -6.0; P = .001).
Conclusions and Relevance


In this study, messages about nonstigmatizing language and effective medication for OUD reduced stigma among health care professionals. Stigma-reduction efforts targeting health care professionals may improve health care system capacity to serve people with OUD.
Trial Registration


ClinicalTrials.gov Identifier: NCT05127707.",2022,"In this study, messages about nonstigmatizing language and effective medication for OUD reduced stigma among health care professionals.","['people with OUD', 'Health care professionals in the US were recruited from 2 national online survey panels (Ipsos KnowledgePanel and SurveyHealthcareGlobus', '1842 participants, the mean (SD) age was 47 (13) years; 1324 participants (71.9%) were female, 145 (7.9%) were Hispanic, 140 (7.6%) were non-Hispanic Black, 1344 (73.0%) were non-Hispanic White, and 213 (11.6%) were of other non-Hispanic race (ie, individuals who did not self-report race as Black or White and did not self-report ethnicity as Hispanic', 'people with opioid use disorder (OUD', 'Health Care Professionals', '1842 participants completed a web-based survey measuring stigma toward people with OUD from November 13 to 30, 2020']","['Exposure to Visual Campaigns and Narrative Vignettes', 'OUD-related messages delivered by a visual campaign alone or in combination with a written narrative vignette', 'visual campaign alone or a visual campaign in combination with a written narrative vignette from the perspective of a simulated patient with OUD, a clinician, or a health care system administrator']","['warmth rating', 'Addiction Stigma', 'levels of stigma', 'Measures\n\n\nDimensions of stigma toward people with OUD', 'level of warmth felt toward people with OUD', '5-point Likert scales that included items about desire for social distance from people with OUD, perception of individual blame for OUD, perspective of OUD as a medical condition, and support for increased governmental spending on OUD treatment']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]","[{'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0085751', 'cui_str': 'Administrators'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",1842.0,0.114462,"In this study, messages about nonstigmatizing language and effective medication for OUD reduced stigma among health care professionals.","[{'ForeName': 'Alene', 'Initials': 'A', 'LastName': 'Kennedy-Hendricks', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Emma E', 'Initials': 'EE', 'LastName': 'McGinty', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Summers', 'Affiliation': 'Johns Hopkins Center for Communication Programs, Baltimore, Maryland.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Krenn', 'Affiliation': 'Johns Hopkins Center for Communication Programs, Baltimore, Maryland.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Fingerhood', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Colleen L', 'Initials': 'CL', 'LastName': 'Barry', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.46971']
1875,35113903,Humidified and standard oxygen therapy in acute severe asthma in children (HUMOX): A pilot randomised controlled trial.,"BACKGROUND


Oxygen (O2) is a mainstay of treatment in acute severe asthma but how it is administered varies widely. The objectives were to examine whether a trial comparing humidified O2 to standard O2 in children is feasible, and specifically to obtain data on recruitment, tolerability and outcome measure stability.
METHODS


Heated humidified, cold humidified and standard O2 treatments were compared for children (2-16 years) with acute severe asthma in a multi-centre, open, parallel, pilot randomised controlled trial (RCT). Multiple outcomes were assessed.
RESULTS


Of 258 children screened, 66 were randomised (heated humidified O2 n = 25; cold humidified O2 n = 21; standard O2 n = 20). Median (IQR) length of stay (hours) in hospital was 37.9 (29.1), 52 (35.4) and 49.1 (29.7) for standard, heated humidified and cold humidified respectively and time (hours) on O2 was 15.9 (9.4), 13.6 (14.9) and 13.1 (14.9) for the three groups respectively. The mean (standard deviation) time (hours) taken to step down nebulised to inhaled treatment was 5.6 (14.3), 35.1 (28.2) and 32.7 (20.1). Asthma Severity Score decreased in all three groups similarly, although missing data prevented complete analysis. Humidified O2 was least well tolerated with eight participants discontinuing their randomised treatment early. An important barrier to recruitment was research nurse availability.
CONCLUSION


Although, the results of this pilot study should not be extrapolated beyond the study sample and inferential conclusions should not be drawn from the results, this is the first RCT to compare humidified and standard O2 therapy in acute severe asthmatics of any age. These findings and accompanying screening data show that a large RCT of O2 therapy is feasible. However, challenges associated with randomisation and data collection should be addressed in any future trial design.",2022,"Asthma Severity Score decreased in all three groups similarly, although missing data prevented complete analysis.","['acute severe asthma', '258 children', 'children (2-16 years) with acute severe asthma in a multi-centre', 'acute severe asthma in children (HUMOX']","['Oxygen (O2', 'Humidified and standard oxygen therapy', 'cold humidified and standard O2 treatments']","['mean (standard deviation) time (hours) taken to step down nebulised to inhaled treatment', 'Median (IQR) length of stay (hours) in hospital', 'Asthma Severity Score']","[{'cui': 'C0038218', 'cui_str': 'Acute severe exacerbation of asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0581122', 'cui_str': 'Asthma severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",258.0,0.288611,"Asthma Severity Score decreased in all three groups similarly, although missing data prevented complete analysis.","[{'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'McNamara', 'Affiliation': ""Department of Child Health (University of Liverpool), Institute in the Park, Alder Hey Children's NHS Foundation Trust, Liverpool, United Kingdom.""}, {'ForeName': 'Dannii', 'Initials': 'D', 'LastName': 'Clayton', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, a member of the Liverpool Health Partners, Liverpool, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Burchett', 'Affiliation': 'Paediatric Department, The Longhouse, Countess of Chester Hospital NHS Foundation Trust, Chester, United Kingdom.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Compton', 'Affiliation': ""Physiotherapy Department, Alder Hey Children's NHS Foundation Trust, Liverpool, United Kingdom.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Peak', 'Affiliation': ""Clinical Research Division, Institute in the Park, Alder Hey Children's NHS Foundation Trust, Liverpool, United Kingdom.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Clark', 'Affiliation': ""Clinical Research Division, Institute in the Park, Alder Hey Children's NHS Foundation Trust, Liverpool, United Kingdom.""}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, a member of the Liverpool Health Partners, Liverpool, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0263044']
1876,35114340,Evaluating the safety and efficacy of a polyherbal Unani formulation in dyslipidaemia-a prospective randomized controlled trial.,"ETHNOPHARMACOLOGICAL RELEVANCE


Unani System of Medicine offers treatment for obesity and dyslipidaemia. Jawarish Falafili (JF) is a Unani polyherbal pharmacopoeial preparation. It has been used in the treatment of obesity for a long time. Dyslipidaemia is a recognised modifiable risk factor for hypertension, ischemic heart disease and stroke. Limitations of the current conventional therapy have provided scope for research of a potential drug in this medical condition. It was hypothesised that JF may ameliorate dyslipidaemia in human participants.
AIM OF THE STUDY


The main objective of this study was to evaluate the safety and efficacy of the JF.
MATERIALS AND METHODS


This was a prospective randomized, active-controlled, open-label and parallel-group study. We randomized 74 participants of dyslipidaemia into treatment (n = 38) and control (n = 36) groups. Of them, 30 participants in each group completed the trial. The participants of any sex aged between 30 and 60 years, with serum total cholesterol (TC) ≥200 mg/dl and/or serum triglycerides (TG) ≥150 mg/dl and/or low-density lipoprotein cholesterol (LDL-C) level ≥130 mg/dl and/or high-density lipoprotein cholesterol (HDL-C) level <40 mg/dl were enrolled in this study. The participants of the treatment group were treated with JF (10 gm/day) once and atorvastatin (20 mg/day) was given to the control group for 90 days once at night daily.
RESULTS


We observed a significant reduction (treatment group versus control group) in mean serum TC by 22.89% versus 19.36%, TG by 29.90% versus 23.26% and LDL-C by 29.16% versus 27.92% from baseline (p < 0.05). But the change in mean serum HDL-C levels post-treatment was insignificant in both groups (p > 0.05). On intergroup comparison, the magnitude of the difference of mean TC, TG, LDL-C and HDL-C levels between the groups was not statistically significant (p > 0.00.05).
CONCLUSIONS


This study concluded that JF and atorvastatin were equally effective in controlling dyslipidaemia. They were tolerated well by all participants and found safe during the course of treatment.",2022,"We observed a significant reduction (treatment group versus control group) in mean serum TC by 22.89% versus 19.36%, TG by 29.90% versus 23.26% and LDL-C by 29.16% versus 27.92% from baseline (p < 0.05).","['participants of any sex aged between 30 and 60 years, with serum total cholesterol (TC) ≥200\u202fmg/dl and/or serum triglycerides (TG) ≥150\u202fmg/dl and/or low-density lipoprotein cholesterol (LDL-C) level ≥130\u202fmg/dl and/or high-density lipoprotein cholesterol (HDL-C) level <40\u202fmg/dl were enrolled in this study', '30 participants in each group completed the trial', 'human participants', '74 participants of dyslipidaemia into treatment (n\u202f=\u202f38) and control (n\u202f=\u202f36) groups']","['JF', 'JF and atorvastatin', 'polyherbal Unani formulation', 'Jawarish Falafili (JF', 'Medicine', 'atorvastatin']","['mean serum TC', 'mean TC, TG, LDL-C and HDL-C levels', 'mean serum HDL-C levels post-treatment', 'safety and efficacy']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",74.0,0.0204376,"We observed a significant reduction (treatment group versus control group) in mean serum TC by 22.89% versus 19.36%, TG by 29.90% versus 23.26% and LDL-C by 29.16% versus 27.92% from baseline (p < 0.05).","[{'ForeName': 'Qurratul', 'Initials': 'Q', 'LastName': 'Ain', 'Affiliation': 'Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders, Hyderabad, 500032, India. Electronic address: qurratulainjunaid@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nawab', 'Affiliation': 'Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders, Hyderabad, 500032, India. Electronic address: ccrumnawab@gmail.com.'}, {'ForeName': 'Tasleem', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Department of Biochemistry, National Research Institute of Unani Medicine for Skin Disorders, Hyderabad, 500032, India. Electronic address: tasleem.nriumsd@gmail.com.'}, {'ForeName': 'Munawwar H', 'Initials': 'MH', 'LastName': 'Kazmi', 'Affiliation': 'Department of Ilmul Advia (Pharmacology), National Research Institute of Unani Medicine for Skin Disorders, Hyderabad, 500032, India. Electronic address: drmunawwar@yahoo.com.'}, {'ForeName': 'Mohammed Abdul Rasheed', 'Initials': 'MAR', 'LastName': 'Naikodi', 'Affiliation': 'Drug Standardization Research Unit, National Research Institute of Unani Medicine for Skin Disorders, Hyderabad, 500032, India. Electronic address: rasheed.crium@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2022.115036']
1877,35114327,Playing with fruit: An experimental study to test the effectiveness of an online memory advergame to promote children's fruit consumption.,"OBJECTIVE


Literature on food marketing targeting young people reveals that in the last years, sophisticated marketing techniques have been developed to market predominantly unhealthy food products. Much research has been conducted to test the impact of these techniques on subsequent product selection and intake. Less is known about the effects of promoting healthier foods, although the health-related benefits of eating more fruit and vegetables for children are important. The main aim of the present experiment was to examine if an online advergame promoting a fruit brand with food products increased subsequent fruit intake by children.
METHODS


We used a randomized between-subject design with 123 children (age: 7-13 years) who played an advergame that promoted fruit (n = 43), non-food products (n = 40), or were in the control condition (n = 40). Subsequently, we measured the free intake of fruit as main outcome.
RESULTS


Playing the advergame promoting fruit did not stimulate the subsequent intake of fruit. Children in the advergame with fruit ate similar amounts of fruit than children in the control condition. No moderation effects of BMI, hunger, sex and game attitude were found. In addition, Bayesian analyses have been conducted that support the null hypothesis.
DISCUSSION


Previous research has shown that marketing of unhealthy products via advergames affects subsequent intake of the promoted product, but the same effect is not found for healthier foods. We suggest that future research should examine if longer exposure or different forms of novel food marketing are effective in increasing the intake of healthier foods. Until now, it is unclear if advergames as a marketing technique for healthy foods have the same effectiveness on the intake of healthier food products.",2022,Children in the advergame with fruit ate similar amounts of fruit than children in the control condition.,"[""children's fruit consumption"", '123 children (age: 7-13 years) who played an advergame that promoted fruit (n\u202f=\u202f43), non-food products (n\u202f=\u202f40), or were in the control condition (n\u202f=\u202f40', 'children']",['Playing with fruit'],"['BMI, hunger, sex and game attitude']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",123.0,0.0198434,Children in the advergame with fruit ate similar amounts of fruit than children in the control condition.,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Theben', 'Affiliation': 'UPF Barcelona School of Management, Barcelona, Spain. Electronic address: Alexandra.Theben@bsm.upf.edu.'}, {'ForeName': 'Roos', 'Initials': 'R', 'LastName': 'Fink', 'Affiliation': 'Faculty of Communication Science, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Folkvord', 'Affiliation': 'Open Evidence Research, Open Evidence, Barcelona, Spain; Tilburg School of Humanities and Digital Sciences, Tilburg University, the Netherlands.'}]",Appetite,['10.1016/j.appet.2022.105936']
1878,35114186,A double-blinded randomized controlled trial on the effects of increased intravenous hydration in nulliparas undergoing induction of labor.,"BACKGROUND


Rates of labor induction are increasing, raising concerns related to increased healthcare utilization costs. High-dose intravenous fluid (250 cc/h) has been previously demonstrated to shorten the time to delivery in nulliparous individuals in spontaneous labor. Whether or not this relationship exists among individuals undergoing induction of labor is unknown.
OBJECTIVE


Our study aimed to evaluate the effect of high-dose intravenous hydration on time to delivery among nulliparous individuals undergoing induction of labor.
STUDY DESIGN


Nulliparous individuals presenting for induction of labor with a Bishop score of ≤6 (with and without rupture of membranes) were randomized to receive either 125 cc/h or 250 cc/h of normal saline. The primary outcome was length of labor (defined as time from initiation of study fluids to delivery). Both time to overall delivery and vaginal delivery were evaluated. Secondary outcomes included the lengths of each stage of labor, the percentage of individuals delivering within 24 hours, and maternal and neonatal outcomes, including cesarean delivery rate.
RESULTS


A total of 180 individuals meeting inclusion criteria were enrolled and randomized. Baseline demographic characteristics were similar between groups; however, there was a higher incidence of diabetes mellitus in the group receiving 125 cc/h. Average length of labor was similar between groups (27.6 hours in 250 cc/h and 27.8 hours in 125 cc/h), as was the length of each stage of labor. Cox regression analysis did not demonstrate an effect of fluid rate on time to delivery. Neither the admission Bishop score, body mass index, nor other demographic characteristics affected time to delivery or vaginal delivery. There were no differences in maternal or neonatal outcomes, including overall cesarean delivery rate, clinically apparent iatrogenic intraamniotic infection, Apgar scores, need for neonatal phototherapy, or neonatal intensive care unit stay.
CONCLUSION


There were no observed differences in the length of labor or maternal or neonatal outcomes with the administration of an increased rate of intravenous fluids among nulliparous individuals undergoing induction of labor.",2022,"There were no differences in maternal or neonatal outcomes including overall cesarean rate, clinically apparent iatrogenic intra-amniotic infection, Apgar scores, need for neonatal phototherapy, or neonatal intensive care unit stay.
","['Nulliparous individuals presenting for induction of labor with a Bishop score of ≤ 6 (with and without rupture of membranes', 'nulliparous individuals undergoing induction of labor', '180 individuals meeting inclusion criteria were enrolled and randomized', 'Nulliparas Undergoing Induction of Labor', 'nulliparous individuals in spontaneous labor']","['Intravenous Hydration', 'high-dose intravenous hydration', '125cc/hr or 250cc/hr of normal saline']","['maternal or neonatal outcomes including overall cesarean rate, clinically apparent iatrogenic intra-amniotic infection, Apgar scores, need for neonatal phototherapy, or neonatal intensive care unit stay', 'Average length of labor', 'admission bishop score, BMI, nor other demographic characteristics impacted time to delivery or vaginal delivery', 'lengths of each stage of labor, the percentage of individuals delivering within 24 hours, and maternal and neonatal outcomes, including cesarean delivery rate', 'rate of intravenous fluids', 'length of labor (defined as time from initiation of study fluids to delivery', 'Baseline demographic characteristics', 'length of labor or maternal or neonatal outcomes', 'overall delivery and vaginal delivery']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0233308', 'cui_str': 'Spontaneous rupture of fetal membranes'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",180.0,0.417848,"There were no differences in maternal or neonatal outcomes including overall cesarean rate, clinically apparent iatrogenic intra-amniotic infection, Apgar scores, need for neonatal phototherapy, or neonatal intensive care unit stay.
","[{'ForeName': 'Jennifer Y', 'Initials': 'JY', 'LastName': 'Duffy', 'Affiliation': ""Department of Obstetrics and Gynecology, University of California, Irvine, CA; Miller Children's and Women's Hospital, Long Beach, CA. Electronic address: jennifer.duffy@ucsf.edu.""}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University, Stanford, CA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Fong', 'Affiliation': 'Department of Maternal-Fetal Medicine, Kaiser Permanente Irvine Medical Center, Irvine, CA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Garite', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Irvine, CA.'}, {'ForeName': 'Vineet K', 'Initials': 'VK', 'LastName': 'Shrivastava', 'Affiliation': ""Miller Children's and Women's Hospital, Long Beach, CA.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2022.01.024']
1879,35114798,Influence of Baseline Diastolic Blood Pressure on the Effects of Intensive Systolic Blood Pressure Lowering on the Risk of Stroke.,"BACKGROUND


Guidelines recommend lowering systolic blood pressure below 130 mm Hg, irrespective of previous strokes. However, there is a concern that lowering systolic blood pressure in people with low baseline diastolic blood pressure might increase the risk of stroke.
METHODS


We conducted a secondary analysis of the Secondary Prevention of Small Subcortical Strokes trial that randomly assigned participants with a history of subcortical strokes to an intensive (<130 mm Hg; N=1519) or standard (130-149 mm Hg; N=1501) systolic targets. We examined the effects of blood pressure intervention on stroke and cardiovascular composite across the range of baseline diastolic blood pressure in spline regression models and tested for interaction of baseline diastolic blood pressure with the intervention on outcomes.
RESULTS


Mean baseline systolic and diastolic blood pressures were 143±19 and 78±11 mm Hg, respectively. Within each baseline diastolic blood pressure tertile, the achieved diastolic was lower in the intensive versus standard arm. There were 275 stroke events over 10 889 years of follow-up. Lower baseline diastolic blood pressure was associated with increased risk of stroke in an observational spline regression model. Hazard ratios relating blood pressure intervention with the risk of stroke in the lowest (hazard ratio, 0.78 [95% CI, 0.52-1.16]) and the highest (hazard ratio, 0.80 [95% CI, 0.53-1.21]) baseline diastolic tertiles were similar ( P =0.95). Results were similar for the cardiovascular composite.
CONCLUSIONS


Intensive systolic control does not appear to increase the risk of stroke in those with low baseline diastolic blood pressure and prior stroke.
REGISTRATION


URL: https://www.clinicaltrials.gov; Unique identifier: NCT00059306.",2022,"Hazard ratios relating blood pressure intervention with the risk of stroke in the lowest (hazard ratio, 0.78",['Small Subcortical Strokes trial that randomly assigned participants with a history of subcortical strokes to an intensive (<130 mm Hg; N=1519) or standard (130-149 mm Hg; N=1501) systolic targets'],"['Intensive Systolic Blood Pressure Lowering', 'blood pressure intervention']","['Risk of Stroke', 'systolic blood pressure', 'baseline diastolic tertiles', 'risk of stroke', 'Lower baseline diastolic blood pressure', 'Mean baseline systolic and diastolic blood pressures', 'diastolic blood pressure tertile']","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4274392', 'cui_str': 'Baseline diastolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.366174,"Hazard ratios relating blood pressure intervention with the risk of stroke in the lowest (hazard ratio, 0.78","[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Shihab', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City (S.S., R.E.B., N.A., G.W., S.B.).'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Boucher', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City (S.S., R.E.B., N.A., G.W., S.B.).'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Abraham', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City (S.S., R.E.B., N.A., G.W., S.B.).'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City (S.S., R.E.B., N.A., G.W., S.B.).'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Division of Nephrology & Hypertension, University of Utah School of Medicine, Salt Lake City (S.S., R.E.B., N.A., G.W., S.B.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.121.18172']
1880,35115182,Infrared Vein Imaging for Insertion of Peripheral Intravenous Catheter for Patients Requiring Isolation for Severe Acute Respiratory Syndrome Coronavirus 2 Infection: A Nonrandomized Clinical Trial.,"INTRODUCTION


Establishing intravenous access is essential but may be difficult to achieve for patients requiring isolation for severe acute respiratory syndrome coronavirus 2 infection. This study aimed to investigate the effectiveness of an infrared vein visualizer on the peripheral intravenous catheter therapy in patients with coronavirus disease 2019.
METHODS


A nonrandomized clinical trial was performed. In total, 122 patients with coronavirus disease 2019 who required peripheral intravenous cannulation were divided into 2 groups with 60 in the control group and 62 in the intervention group. A conventional venipuncture method was applied to the control group, whereas an infrared vein imaging device was applied in the intervention group. The first attempt success rate, total procedure time, and patients' satisfaction score were compared between the 2 groups using chi-square, t test, and z test (also known as Mann-Whitney U test) statistics.
RESULTS


The first attempt success rate in the intervention group was significantly higher than that of control group (91.94% vs 76.67%, ꭓ 2  = 5.41, P = .02). The procedure time was shorter in the intervention group (mean [SD], 211.44 [68.58] seconds vs 388.27 [88.97] seconds, t = 12.27, P < .001). Patients from the intervention group experienced a higher degree of satisfaction (7.5 vs 6, z = -3.31, P < .001).
DISCUSSION


Peripheral intravenous catheter insertion assisted by an infrared vein visualizer could improve the first attempt success rate of venipuncture, shorten the procedure time, and increase patients' satisfaction.",2021,"The first attempt success rate in the intervention group was significantly higher than that of control group (91.94% vs 76.67%, ꭓ 2  = 5.41, P = .02).","['Patients Requiring Isolation for Severe Acute Respiratory Syndrome Coronavirus', '2 Infection', '122 patients with coronavirus disease 2019 who required peripheral intravenous cannulation', 'patients with coronavirus disease 2019']","['infrared vein visualizer', 'peripheral intravenous catheter therapy', 'Infrared Vein Imaging for Insertion of Peripheral Intravenous Catheter']","['success rate', 'procedure time', 'higher degree of satisfaction', ""success rate, total procedure time, and patients' satisfaction score""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C1175743', 'cui_str': 'SARS coronavirus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}]","[{'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",122.0,0.0203571,"The first attempt success rate in the intervention group was significantly higher than that of control group (91.94% vs 76.67%, ꭓ 2  = 5.41, P = .02).","[{'ForeName': 'Ziyun', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Xuejiao', 'Initials': 'X', 'LastName': 'Lou', 'Affiliation': ''}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Xifei', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2021.10.001']
1881,35115450,Noninvasive Prediction of Congenital Cytomegalovirus Infection After Maternal Primary Infection.,"OBJECTIVE


To develop and internally validate a noninvasive method for the prediction of congenital cytomegalovirus (CMV) infection after primary maternal CMV infection.
METHODS


We conducted a secondary analysis of a multicenter randomized placebo-controlled trial of CMV hyperimmune globulin to prevent congenital infection. Women were eligible if they had primary CMV infection, defined as detectable plasma CMV-specific immunoglobulin (Ig)M and CMV-specific IgG with avidity less than 50% before 24 weeks of gestation or IgG seroconversion before 28 weeks, and were carrying a singleton fetus without ultrasonographic findings suggestive of CMV infection. Antibody assays were performed in a single reference laboratory. Congenital infection was defined as CMV detection in amniotic fluid, neonatal urine or saliva, or postmortem tissue. Using backward elimination, we developed logit models for prediction of congenital infection using factors known at randomization. The performance of the model was assessed using leave-one-out cross-validation (a method of internal validation).
RESULTS


Of 399 women enrolled in the trial, 344 (86%) had informative data for this analysis. Congenital infection occurred in 68 pregnancies (20%). The best performing model included government-assisted insurance, IgM index 4.5 or higher, IgG avidity less than 32%, and whether CMV was detectable by polymerase chain reaction in maternal plasma at the time of randomization. Cross-validation showed an average area under the curve of 0.76 (95% CI 0.70-0.82), indicating moderate discriminatory ability. More parsimonious one-, two-, and three-factor models performed significantly less well than the four-factor model. Examples of prediction with the four-factor model: for a woman with government-assisted insurance, avidity less than 32%, IgM index 4.5 or higher, and detectable plasma CMV, probability of congenital infection was 0.69 (95% CI 0.53-0.82); for a woman with private insurance, avidity 32% or greater, IgM index less than 4.5, and undetectable plasma CMV, probability of infection was 0.03 (95% CI 0.02-0.07).
CONCLUSION


We developed models to predict congenital CMV infection in the presence of primary maternal CMV infection and absence of ultrasonographic findings suggestive of congenital infection. These models may be useful for patient counseling and decision making.",2022,"Cross-validation showed an average area under the curve of 0.76 (95% CI 0.70-0.82), indicating moderate discriminatory ability.","['Women were eligible if they had primary CMV infection, defined as detectable plasma CMV-specific immunoglobulin (Ig)M and CMV-specific IgG with avidity less than 50% before 24 weeks of gestation or IgG seroconversion before 28 weeks, and were carrying a singleton fetus without ultrasonographic findings suggestive of CMV infection', '399 women enrolled in the trial, 344 (86%) had informative data for this analysis']","['placebo', 'CMV hyperimmune globulin']","['plasma CMV, probability of congenital infection', 'Congenital infection', 'congenital infection', 'CMV detection in amniotic fluid, neonatal urine or saliva, or postmortem tissue', 'undetectable plasma CMV, probability of infection', 'Congenital Cytomegalovirus Infection']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0358334', 'cui_str': 'Specific immunoglobulins'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0017649', 'cui_str': 'Globulin'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0275544', 'cui_str': 'Congenital infectious disease'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0002638', 'cui_str': 'Amniotic fluid'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0444184', 'cui_str': 'Postmortem tissue sample'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0158945', 'cui_str': 'Congenital cytomegalovirus infection'}]",399.0,0.257951,"Cross-validation showed an average area under the curve of 0.76 (95% CI 0.70-0.82), indicating moderate discriminatory ability.","[{'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': ""Departments of Obstetrics and Gynecology, Brown University, Providence, Rhode Island, University of Texas Medical Branch at Galveston, Galveston, Texas, Northwestern University, Chicago, Illinois, Columbia University, New York, New York, University of Utah Health Sciences Center, Salt Lake City, Utah, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Alabama at Birmingham, Birmingham, Alabama, The Ohio State University, Columbus, Ohio, Duke University, Durham, North Carolina University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, Case Western Reserve University, Cleveland, Ohio, University of Texas Health Science Center at Houston and Children's Memorial Hermann Hospital, Houston, Texas, Stanford University, Stanford, California, University of Texas Southwestern Medical Center, Dallas, Texas University of Pennsylvania, Philadelphia, Pennsylvania, University of Pittsburgh, Pittsburgh, Pennsylvania, Madigan Army Medical Center, Joint Base Lewis-McChord, Washington, and Washington University in St. Louis, St. Louis, Missouri; the Departments of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, and Duke University, Durham, North Carolina; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.""}, {'ForeName': 'Lida M', 'Initials': 'LM', 'LastName': 'Fette', 'Affiliation': ''}, {'ForeName': 'Brenna L', 'Initials': 'BL', 'LastName': 'Hughes', 'Affiliation': ''}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': ''}, {'ForeName': 'Mara J', 'Initials': 'MJ', 'LastName': 'Dinsmoor', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pass', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Allard', 'Affiliation': ''}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': ''}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Clifton', 'Affiliation': ''}, {'ForeName': 'Frances M', 'Initials': 'FM', 'LastName': 'Saccoccio', 'Affiliation': ''}, {'ForeName': 'Sallie R', 'Initials': 'SR', 'LastName': 'Permar', 'Affiliation': ''}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Gyamfi-Bannerman', 'Affiliation': ''}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Varner', 'Affiliation': ''}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Goodnight', 'Affiliation': ''}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ''}, {'ForeName': 'Maged M', 'Initials': 'MM', 'LastName': 'Costantine', 'Affiliation': ''}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': ''}, {'ForeName': 'Kent D', 'Initials': 'KD', 'LastName': 'Heyborne', 'Affiliation': ''}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': ''}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': ''}, {'ForeName': 'Yasser Y', 'Initials': 'YY', 'LastName': 'El-Sayed', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Parry', 'Affiliation': ''}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': ''}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Napolitano', 'Affiliation': ''}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004691']
1882,35120193,"Hyperoxia and Antioxidants for Myocardial Injury in Noncardiac Surgery: A 2 × 2 Factorial, Blinded, Randomized Clinical Trial.","BACKGROUND


Hyperoxia and oxidative stress may be associated with increased risk of myocardial injury. The authors hypothesized that a perioperative inspiratory oxygen fraction of 0.80 versus 0.30 would increase the degree of myocardial injury within the first 3 days of surgery, and that an antioxidant intervention would reduce degree of myocardial injury versus placebo.
METHODS


A 2 × 2 factorial, randomized, blinded, multicenter trial enrolled patients older than 45 yr who had cardiovascular risk factors undergoing major noncardiac surgery. Factorial randomization allocated patients to one of two oxygen interventions from intubation and at 2 h after surgery, as well as antioxidant intervention or matching placebo. Antioxidants were 3 g IV vitamin C and 100 mg/kg N-acetylcysteine. The primary outcome was the degree of myocardial injury assessed by the area under the curve for high-sensitive troponin within the first 3 postoperative days.
RESULTS


The authors randomized 600 participants from April 2018 to January 2020 and analyzed 576 patients for the primary outcome. Baseline and intraoperative characteristics did not differ between groups. The primary outcome was 35 ng · day/l (19 to 58) in the 80% oxygen group; 35 ng · day/l (17 to 56) in the 30% oxygen group; 35 ng · day/l (19 to 54) in the antioxidants group; and 33 ng · day/l (18 to 57) in the placebo group. The median difference between oxygen groups was 1.5 ng · day/l (95% CI, -2.5 to 5.3; P = 0.202) and -0.5 ng · day/l (95% CI, -4.5 to 3.0; P = 0.228) between antioxidant groups. Mortality at 30 days occurred in 9 of 576 patients (1.6%; odds ratio, 2.01 [95% CI, 0.50 to 8.1]; P = 0.329 for the 80% vs. 30% oxygen groups; and odds ratio, 0.79 [95% CI, 0.214 to 2.99]; P = 0.732 for the antioxidants vs. placebo groups).
CONCLUSIONS


Perioperative interventions with high inspiratory oxygen fraction and antioxidants did not change the degree of myocardial injury within the first 3 days of surgery. This implies safety with 80% oxygen and no cardiovascular benefits of vitamin C and N-acetylcysteine in major noncardiac surgery.
EDITOR’S PERSPECTIVE


",2022,"Mortality at 30 days occurred in 9 of 576 patients (1.6%; odds ratio, 2.01 [95% CI, 0.50 to 8.1]; P = 0.329 for the 80% vs. 30% oxygen groups; and odds ratio, 0.79","['multicenter trial enrolled patients older than 45 yr who had cardiovascular risk factors undergoing major noncardiac surgery', 'Myocardial Injury in Noncardiac Surgery', '600 participants from April 2018 to January 2020 and analyzed 576 patients for the primary outcome']","['placebo', 'vitamin C and 100 mg/kg N-acetylcysteine', 'oxygen interventions from intubation and at 2 h after surgery, as well as antioxidant intervention or matching placebo', 'antioxidant intervention', 'vitamin C and N-acetylcysteine', 'Hyperoxia and Antioxidants']","['degree of myocardial injury assessed by the area under the curve for high-sensitive troponin within the first 3 postoperative days', 'Mortality', 'degree of myocardial injury']","[{'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0242706', 'cui_str': 'Hyperoxia'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",600.0,0.893459,"Mortality at 30 days occurred in 9 of 576 patients (1.6%; odds ratio, 2.01 [95% CI, 0.50 to 8.1]; P = 0.329 for the 80% vs. 30% oxygen groups; and odds ratio, 0.79","[{'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Holse', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark; Copenhagen Center for Translational Research, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Eske K', 'Initials': 'EK', 'LastName': 'Aasvang', 'Affiliation': 'Department of Anaesthesia, Center for Cancer and Organ Diseases, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Vester-Andersen', 'Affiliation': 'Herlev Anaesthesia Critical and Emergency Care Science Unit (ACES), Department of Anesthesiology, Copenhagen University Hospital Herlev-Gentofte, Herlev, Denmark.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Rasmussen', 'Affiliation': 'Centre of Head and Orthopaedics, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': 'Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'Musculoskeletal Statistics Unit, the Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark.'}, {'ForeName': 'Lars N', 'Initials': 'LN', 'LastName': 'Jorgensen', 'Affiliation': 'Digestive Disease Center, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Sofie S', 'Initials': 'SS', 'LastName': 'Pedersen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark; Copenhagen Center for Translational Research, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Frederik C', 'Initials': 'FC', 'LastName': 'Loft', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark; Copenhagen Center for Translational Research, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Hannibal', 'Initials': 'H', 'LastName': 'Troensegaard', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark; Copenhagen Center for Translational Research, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Marie-Louise', 'Initials': 'ML', 'LastName': 'Mørkenborg', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark; Copenhagen Center for Translational Research, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Zara R', 'Initials': 'ZR', 'LastName': 'Stisen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark; Copenhagen Center for Translational Research, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Rünitz', 'Affiliation': 'Department of Anaesthesia, Center for Cancer and Organ Diseases, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jonas P', 'Initials': 'JP', 'LastName': 'Eiberg', 'Affiliation': 'Department of Vascular Surgery, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Copenhagen Academy for Medical Education and Simulation (CAMES), Capital Region of Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Hansted', 'Affiliation': 'Herlev Anaesthesia Critical and Emergency Care Science Unit (ACES), Department of Anesthesiology, Copenhagen University Hospital Herlev-Gentofte, Herlev, Denmark.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark; Copenhagen Center for Translational Research, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000004117']
1883,35123096,"Two-Step Strategy, FIB-4 Followed by Magnetic Resonance Elastography, for Detecting Advanced Fibrosis in NAFLD.","BACKGROUND & AIMS


A two-step strategy combining a serum marker and magnetic resonance elastography (MRE) for detecting advanced fibrosis (stage 3-4) among patients with nonalcoholic fatty liver disease (NAFLD) has been proposed, but its diagnostic accuracy has not been evaluated. In this multicenter study, we aimed to investigate the diagnostic accuracy of a two-step strategy including Fibrosis-4 (FIB-4) followed by MRE.
METHODS


In this multicenter study, 806 patients with biopsy-proven NAFLD who underwent contemporaneous MRE were enrolled and randomly assigned to training and validation cohorts. As a first step, patients with FIB-4 <1.3 were defined as test negative regardless of MRE. As a second step, among patients with FIB-4 ≥1.3, MRE <3.6 and ≥3.6 kPa were defined as test negative and positive. The primary outcome was the diagnostic accuracy for advanced fibrosis comparing MRE alone versus the two-step strategy.
RESULTS


Area under the receiver characteristic curves of MRE alone and the two-step strategy were 0.840 and 0.853 in the training cohort (P = .4) and 0.867 and 0.834 in the validation cohort (P = .2), respectively, and the diagnostic accuracy was comparable between the 2 methods. In the entire cohort, negative predictive value (NPV) and positive predictive value (PPV) of MRE for advanced fibrosis were 92.2% and 73.7%, respectively, whereas NPV at the first and second step and PPV at the second step were 90.9%, 84.4%, and 77.0%, respectively.
CONCLUSIONS


The diagnostic accuracy of the two-step strategy was comparable to MRE and could reduce cost by reducing excessive MRE. Therefore, the two-step strategy could be used as a screening method in a large population.",2022,The diagnostic accuracy of the two-step strategy was comparable to MRE and could reduce cost by reducing excessive MRE.,"['patients with nonalcoholic fatty liver disease (NAFLD', '806 patients with biopsy-proven NAFLD who underwent contemporaneous MRE']",['magnetic resonance elastography (MRE'],"['negative predictive value (NPV) and positive predictive value (PPV) of MRE for advanced fibrosis', 'diagnostic accuracy for advanced fibrosis', 'diagnostic accuracy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C1518156', 'cui_str': 'Magnetic resonance elastography'}]","[{'cui': 'C1518156', 'cui_str': 'Magnetic resonance elastography'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1518156', 'cui_str': 'Magnetic resonance elastography'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",806.0,0.0568376,The diagnostic accuracy of the two-step strategy was comparable to MRE and could reduce cost by reducing excessive MRE.,"[{'ForeName': 'Nobuharu', 'Initials': 'N', 'LastName': 'Tamaki', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California San Diego, La Jolla, California; Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Imajo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Kanagawa, Japan; Department of Gastroenterology, Shin-yurigaoka General Hospital, Kanagawa, Japan.'}, {'ForeName': 'Suzanne R', 'Initials': 'SR', 'LastName': 'Sharpton', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Jinho', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Sutter', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Kawamura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Kanagawa, Japan; Department of Gastroenterology, Shin-yurigaoka General Hospital, Kanagawa, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Yoneda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Valasek', 'Affiliation': 'Department of Pathology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Behling', 'Affiliation': 'Sharp Medical Group, Department of Pathology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Claude B', 'Initials': 'CB', 'LastName': 'Sirlin', 'Affiliation': 'Liver Imaging Group, Department of Radiology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kurosaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.'}, {'ForeName': 'Namiki', 'Initials': 'N', 'LastName': 'Izumi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California San Diego, La Jolla, California; Division of Epidemiology, Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California. Electronic address: roloomba@ucsd.edu.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2022.01.023']
1884,35123075,Reducing parental anxiety during oral food challenges: A randomized controlled trial of deep breathing exercises.,,2022,,[],['deep breathing exercises'],['parental anxiety'],[],"[{'cui': 'C0454496', 'cui_str': 'Deep breathing exercises'}]","[{'cui': 'C0577602', 'cui_str': 'Parental anxiety'}]",,0.251881,,"[{'ForeName': 'Chantel E', 'Initials': 'CE', 'LastName': 'Canessa', 'Affiliation': 'Division of Speciality Medicine, Department of Pediatrics, The University of British Columbia, Vancouver, Canada; Adjunct Faculty, School of Nursing, The University of British Columbia, Vancouver, Canada. Electronic address: ccanessa2@cw.bc.ca.'}, {'ForeName': 'Lianne', 'Initials': 'L', 'LastName': 'Soller', 'Affiliation': ""Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine, The University of British Columbia, Vancouver, Canada; British Columbia Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'To', 'Affiliation': ""Department of Psychology, British Columbia Children's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Newlove', 'Affiliation': ""Department of Psychology, British Columbia Children's Hospital, Vancouver, British Columbia, Canada; Department of Psychology, The University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Edmond S', 'Initials': 'ES', 'LastName': 'Chan', 'Affiliation': ""Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine, The University of British Columbia, Vancouver, Canada; British Columbia Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2022.01.029']
1885,35123016,"Blinded, parallel and randomized clinical evaluation of in-office dental bleaching with violet LED (405-410nm).","This clinical study evaluated the effect of bleaching performed with violet LED light (405-410 nm), either combined with hydrogen peroxide (HP) gel, or not, on color change, dental sensitivity, participants' satisfaction and impact on their quality of life. A hundred participants were divided into one of the groups (n = 25): G1 - 35% HP (4 sessions, 1x/week); G2 - violet LED (4 sessions, 1x/week); G3 - violet LED (4 sessions, 2x/week); G4 - hybrid technique (violet LED + 35% HP; 4 sessions, 1x/week). Color evaluation was performed with colorimetric tests (objective and subjective), before, 14 days and 3 months after completion. Additionally, satisfaction with treatment, impact on quality of life (OHIP-14) and dental sensitivity were recorded. The data were submitted to statistical analysis, considering a significance level of 5%, with the exception of the data from the questionnaire on satisfaction (descriptive analysis). Two-way ANOVA and Tukey tests showed that there was no difference between color variation resulting from techniques used in G1 and G4; those used in G2 and G3 did not differ and were less effective for bleaching than those of the other groups, in both subjective and objective evaluations. Regarding tooth sensitivity, subjects in G2 and G3 experienced no sensitivity, ​​while those in G4 showed lower sensitivity values than those in G1. With respect to quality of life, only subjects in G1 and G2 showed a significant positive impact. Among the evaluated techniques, the hybrid type seemed to be a good alternative, showing effective bleaching with less tooth sensitivity.",2022,"Two-way ANOVA and Tukey tests showed that there was no difference between color variation resulting from techniques used in G1 and G4; those used in G2 and G3 did not differ and were less effective for bleaching than those of the other groups, in both subjective and objective evaluations.",['A hundred participants were divided into one of the groups (n\u202f=\u202f25'],"['office Dental Bleaching with Violet LED', 'bleaching performed with violet LED light (405-410 nm), either combined with hydrogen peroxide (HP) gel', 'G2 - violet LED', 'G1 - 35% HP', 'G3 - violet LED (4 sessions, 2x/week); G4 - hybrid technique (violet LED\u202f+\u202f35% HP']","['quality of life (OHIP-14) and dental sensitivity', 'quality of life', 'sensitivity values']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",0.0,0.0147361,"Two-way ANOVA and Tukey tests showed that there was no difference between color variation resulting from techniques used in G1 and G4; those used in G2 and G3 did not differ and were less effective for bleaching than those of the other groups, in both subjective and objective evaluations.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Mayer-Santos', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo; São Paulo, Brazil. Electronic address: eric.mayer.santos@alumni.usp.br.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bachiega-Silva', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo; São Paulo, Brazil.'}, {'ForeName': 'Caroline Vale', 'Initials': 'CV', 'LastName': 'Twiaschor', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo; São Paulo, Brazil.'}, {'ForeName': 'Carlos Alberto Kenji', 'Initials': 'CAK', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo; São Paulo, Brazil.'}, {'ForeName': 'Giovanna Bueno', 'Initials': 'GB', 'LastName': 'Marinho', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo; São Paulo, Brazil.'}, {'ForeName': 'Aldo Brugnera', 'Initials': 'AB', 'LastName': 'Junior', 'Affiliation': 'Brugnera and Zanin Institute; São Paulo, Brazil.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Zanin', 'Affiliation': 'Brugnera and Zanin Institute; São Paulo, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Brugnera', 'Affiliation': 'Brugnera and Zanin Institute; São Paulo, Brazil.'}, {'ForeName': 'Karen Muller', 'Initials': 'KM', 'LastName': 'Ramalho', 'Affiliation': 'Ibirapuera University, São Paulo, Brazil.'}, {'ForeName': 'Patricia Moreira', 'Initials': 'PM', 'LastName': 'de Freitas', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo; São Paulo, Brazil. Electronic address: pfreitas@usp.br.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2022.102739']
1886,35124345,Steps to recovery: Body weight-supported treadmill training for critically ill patients: A randomized controlled trial.,"PURPOSE


Early mobilization of critically ill patients improves functional recovery, but is often hampered by tubes, drains, monitoring devices and muscular weakness. A mobile treadmill with bodyweight support facilitates early mobilization and may shorten recovery time to independent ambulation as compared to usual care physiotherapy alone.
MATERIALS AND METHODS


Single center RCT, comparing daily bodyweight supported treadmill training (BWSTT) with usual care physiotherapy, in patients who had been or were mechanically ventilated (≥48 h) with ≥MRC grade 2 quadriceps muscle strength. BWSTT consisted of daily treadmill training in addition to usual care physiotherapy (PT). Primary outcome was time to independent ambulation measured in days, using the Functional Ambulation Categories (FAC-score: 3). Secondary outcomes included hospital length of stay and serious adverse events.
RESULTS


The median (IQR) time to independent ambulation was 6 (3 to 9) days in the BWSTT group (n = 19) compared to 11 (7 to 23) days in the usual care group (n = 21, p = 0.063). Hospital length of stay was significantly different in favour of the BWSTT group (p = 0.037). No serious adverse events occurred.
INTERPRETATION


BWSTT seems a promising intervention to enhance recovery of ambulation and shorten hospital length of stay of ICU patients, justifying a sufficiently powered multicenter RCT.
TRIAL REGISTRATION NUMBER


Dutch Trial Register ID: NTR6943.",2022,Hospital length of stay was significantly different in favour of the BWSTT group (p = 0.037).,"['critically ill patients', 'patients who had been or were mechanically ventilated (≥48 h) with ≥MRC grade 2 quadriceps muscle strength']","['daily bodyweight supported treadmill training (BWSTT) with usual care physiotherapy', 'recovery: Body weight-supported treadmill training', 'daily treadmill training']","['functional recovery', 'time to independent ambulation measured in days, using the Functional Ambulation Categories (FAC-score: 3', 'hospital length of stay and serious adverse events', 'median (IQR) time to independent ambulation', 'Hospital length of stay']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0054427', 'cui_str': 'CAF protocol'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0695503,Hospital length of stay was significantly different in favour of the BWSTT group (p = 0.037).,"[{'ForeName': 'Robin C H', 'Initials': 'RCH', 'LastName': 'Kwakman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, Netherlands; Faculty of Health, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, the Netherlands; Education of Physiotherapy, University of Applied Sciences Amsterdam, Amsterdam, the Netherlands. Electronic address: r.c.h.kwakman@hva.nl.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Voorn', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, Netherlands. Electronic address: e.l.voorn@amsterdamumc.nl.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Horn', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Intensive Care, Amsterdam Neurosciences, Meibergdreef 9, Amsterdam, Netherlands. Electronic address: j.horn@amsterdamumc.nl.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Nollet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, Netherlands. Electronic address: f.nollet@amsterdamumc.nl.'}, {'ForeName': 'Raoul H H', 'Initials': 'RHH', 'LastName': 'Engelbert', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, Netherlands; Faculty of Health, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, the Netherlands. Electronic address: r.h.h.engelbert@amsterdamumc.nl.'}, {'ForeName': 'Juultje', 'Initials': 'J', 'LastName': 'Sommers', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, Netherlands. Electronic address: j.sommers@amsterdamumc.nl.'}, {'ForeName': 'Marike', 'Initials': 'M', 'LastName': 'van der Schaaf', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, Netherlands; Faculty of Health, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, the Netherlands. Electronic address: m.vanderschaaf@amsterdamumc.nl.'}]",Journal of critical care,['10.1016/j.jcrc.2022.154000']
1887,35124338,Effects of Neurally Adjusted Ventilation Assist (NAVA) and conventional modes of mechanical ventilation on diaphragm functions: A randomized controlled trial.,"BACKGROUND


Better patient-ventilator interactions, during neurally adjusted ventilator assist (NAVA), are expected to result in lower rate of diaphragm dysfunction.
OBJECTIVE


This study was planned to compare the rate of diaphragm dysfunction between the conventional modes of mechanical ventilation and NAVA.
METHODS


Patients who were initiated on mechanical ventilation for acute respiratory failure were randomized to continue either conventional mode of mechanical ventilation or switched to NAVA. The rates of diaphragm dysfunction were compared between two groups.
RESULTS


This study included 46 participants (male 30/46) with a mean age of 58 years. Mean APACHE II and SOFA scores were 15 and 3, respectively. The mean (SD) diaphragm thickness fraction in the conventional mechanical ventilation and NAVA group were 37.12% (18.48) and 39.27% (27.65), respectively. The diaphragm dysfunction was observed in 5 (22.7%) and 8 (34.7%) patients in NAVA and conventional arm, respectively. There was no statistically significant difference between the two groups (p-value = 0.37). Diaphragm excursion was better in the NAVA group as compared with the conventional mechanical ventilation group. Diaphragm thickness and thickness fraction were comparable between two groups.
CONCLUSION


Switching from the conventional mode of mechanical ventilation to NAVA leads to statistically non-significant reduction in the occurrence of diaphragm dysfunction. Adequately powered studies are required to assess the exact role of NAVA on diaphragm functions.",2022,Switching from the conventional mode of mechanical ventilation to NAVA leads to statistically non-significant reduction in the occurrence of diaphragm dysfunction.,"['Patients who were initiated on mechanical ventilation for acute respiratory failure', '46 participants (male 30/46) with a mean age of 58 years']","['Neurally Adjusted Ventilation Assist (NAVA) and conventional modes of mechanical ventilation', 'NAVA', 'conventional mode of mechanical ventilation or switched to NAVA', 'conventional mechanical ventilation']","['rate of diaphragm dysfunction', 'Mean APACHE II and SOFA scores', 'diaphragm functions', 'mean (SD) diaphragm thickness fraction', 'Diaphragm thickness and thickness fraction', 'Diaphragm excursion', 'diaphragm dysfunction', 'rates of diaphragm dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",46.0,0.123947,Switching from the conventional mode of mechanical ventilation to NAVA leads to statistically non-significant reduction in the occurrence of diaphragm dysfunction.,"[{'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Hadda', 'Affiliation': 'Department of Pulmonary, Critical Care & Sleep Medicine. Electronic address: vijayhadda@yahoo.com.'}, {'ForeName': 'Sourabh', 'Initials': 'S', 'LastName': 'Pahuja', 'Affiliation': 'Department of Pulmonary, Critical Care & Sleep Medicine.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Pulmonary, Critical Care & Sleep Medicine.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Madan', 'Affiliation': 'Department of Pulmonary, Critical Care & Sleep Medicine.'}, {'ForeName': 'Maroof A', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Department of Biostatics.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'Department of Pulmonary, Critical Care & Sleep Medicine.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Guleria', 'Affiliation': 'Department of Pulmonary, Critical Care & Sleep Medicine; All India Institute of Medical Sciences, Ansari Nagar, New Delhi, IN 110029.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2022.01.016']
1888,35124335,Effects of resuscitation guideline terminology on pediatric cardiopulmonary resuscitation.,"OBJECTIVE


This study aimed to investigate the effect of resuscitation guideline terminology on pediatric cardiopulmonary resuscitation (CPR) performance.
METHODS


This was a prospective randomised crossover simulation trial. A total of 32 medical doctors conducted 2-min single-rescuer CPR using the one-handed chest compression technique (OHCC) or two-handed chest compression technique (THCC) on a pediatric manikin. The participants conducted chest compressions according to the chest compression depth (CCD) target of '5 cm (Test 1)' or 'at least one third of the anterior-posterior dimension of the chest (Test 2)' in a random order.
RESULTS


In both techniques (OHCC or THCC), the average CCD of Test 1 were significantly lower than those of Test 2 (OHCC: 50.0 mm [46.0-52.0 mm] in Test 1 vs. 52.0 mm [50.3-55.0 mm] in Test 2, P = 0.001; THCC: 52.0 mm [50.3-55.0 mm] in Test 1 vs. 58.0 mm [54.0-62.0 mm] in Test 2, P < 0.001). The adequacy of the chest compressions was also superior in Test 2 (OHCC: 63.0% [7.5-95.8%] in Test 1 vs. 96.5% [78.8-99.9%] in Test 2, P < 0.001; THCC: 96.5% [78.8-99.9%] in Test 1 vs. 100.0% [100.0-100.0%] in Test 2, P < 0.001). Ventilation parameters were not significantly different between Tests 1 and 2.
CONCLUSIONS


Average CCD during simulated pediatric CPR according to the CCD target of '5 cm' was significantly lower than those according to the CCD target of 'at least one third of the anterior-posterior dimension of the chest'.",2022,"Ventilation parameters were not significantly different between Tests 1 and 2.
","['32 medical doctors conducted', 'pediatric cardiopulmonary resuscitation']","['resuscitation guideline terminology', '2-min single-rescuer CPR using the one-handed chest compression technique (OHCC) or two-handed chest compression technique (THCC', 'techniques (OHCC or THCC']","['adequacy of the chest compressions', 'Ventilation parameters']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0028275', 'cui_str': 'Terminology'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0145271', 'cui_str': 'testosterone-3-(n-hexyl)cyclobutane carboxylate'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",32.0,0.0309927,"Ventilation parameters were not significantly different between Tests 1 and 2.
","[{'ForeName': 'Hyeonseok', 'Initials': 'H', 'LastName': 'Noh', 'Affiliation': 'Department of Emergency Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Wongyu', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dongjun', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Emergency Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Je Hyeok', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Department of Emergency Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea. Electronic address: jehyeokoh@cau.ac.kr.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2022.01.051']
1889,35124320,"Exploratory analysis of biomarkers associated with clinical outcomes from the study of palbociclib plus endocrine therapy in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer.","BACKGROUND


Palbociclib plus endocrine therapy (ET) demonstrated significant progression-free survival (PFS) benefit in Young Pearl, a randomized phase ll trial comparing palbociclib + ET versus capecitabine in premenopausal women with hormone receptor positive, HER2 negative metastatic breast cancer (MBC). This exploratory analysis investigated potential biomarkers of palbociclib plus ET on PFS.
PATIENTS AND METHODS


Of 178 patients randomized (92 palbociclib plus ET; 86 capecitabine), we performed targeted sequencing (141 patients) and whole transcriptome sequencing (165 patients) using baseline tumor samples to examine genomic alteration in relation to drug response on PFS. Hazard ratios (HRs) were estimated using unstratified Cox proportional hazards models.
RESULTS


PIK3CA (41%) and TP53 (33%) mutations and CCND1 copy number variation (29%) were found most frequently in targeted sequencing of 141 patients. ESR1 mutations were found only in 3.5% of patients of this population. Luminal type showed better prognosis in palbociclib + ET arm but no impact on PFS difference in capecitabine arm. High TMB, TP53 mutation, PTEN loss of function mutation and RB1 pathway alteration showed worse prognosis in palbociclib plus ET arm. Patients with BRCA2 pathogenic mutations showed worse prognosis regardless of PAM50 subtypes. AURKA mutation/amplification, BRIP1/MYC/RAD51C amplification were significantly associated to the patients with short PFS <6 month.
CONCLUSION


Of palbociclib plus ET, luminal type showed better prognosis and BRCA2 pathogenic mutation showed worse prognosis regardless luminal/non-luminal type. Further exploration of molecular variables is warranted to determine and validate biomarkers of efficacy and resistance.",2022,"AURKA mutation/amplification, BRIP1/MYC/RAD51C amplification were significantly associated to the patients with short PFS <6 month.
","['premenopausal women with hormone receptor positive, HER2 negative metastatic breast cancer (MBC', 'Patients with BRCA2 pathogenic mutations', 'premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer', 'Of 178 patients randomized (92']","['palbociclib\xa0+\xa0ET versus capecitabine', 'palbociclib plus endocrine therapy', 'palbociclib plus ET; 86 capecitabine', 'whole transcriptome sequencing', 'palbociclib plus ET', 'Palbociclib plus endocrine therapy (ET']","['PFS difference', 'ESR1 mutations', 'Hazard ratios (HRs']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2973986', 'cui_str': 'BRCA2 protein, human'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4086963', 'cui_str': 'Complete Transcriptome Sequencing'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",178.0,0.101878,"AURKA mutation/amplification, BRIP1/MYC/RAD51C amplification were significantly associated to the patients with short PFS <6 month.
","[{'ForeName': 'Soohyeon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Division of Oncology-Hematology, Department of Internal Medicine, Korea University College of Medicine, Korea University Anam Hospital, Seoul, South Korea.'}, {'ForeName': 'Kyunghee', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Genome Institute, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Gun Min', 'Initials': 'GM', 'LastName': 'Kim', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seok Yun', 'Initials': 'SY', 'LastName': 'Kang', 'Affiliation': 'Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea.'}, {'ForeName': 'In Hae', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': 'Department of Medical Oncology, Korea University College of Medicine, Korea University Guro Hospital, Seoul, South Korea.'}, {'ForeName': 'Jee Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.'}, {'ForeName': 'Hee Kyung', 'Initials': 'HK', 'LastName': 'Ahn', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Woong-Yang', 'Initials': 'WY', 'LastName': 'Park', 'Affiliation': 'Samsung Genome Institute, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, South Korea. Electronic address: moisa@snu.ac.kr.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: yhparkhmo@skku.edu.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2022.01.014']
1890,35129441,[Effects of oral vitamin D 3  supplementation in Crohn's disease patients: Modulation of clinical active/remission phases by pro-inflammatory cytokines profile and oxidative stress].,"The 25-hydroxyvitamin D 3  (25OHD 3 ) deficiency in Crohn's disease (CD) is associated with the immune system dysfunction and redox status alteration. These two events affect intestinal mucosal function through macrophages cells infiltration and to lead a pro-inflammatory cytokines storm and ROS (reactive oxygen species) overproduction. The objective of this study was to investigate the immunomodulatory and antioxidant effects of vitamin D 3  supplementation (DS 3 ) in clinical active phase. A cohort of 262 CD patients and vitamin D deficient (< 50 nmol/L or < 20 ng/mL) was randomized into 2 groups according to the DS 3  doses at 200,000 IU/month (D 200  group) versus 6,000 IU/day (D 6  group). Serum 25OHD 3  levels were assessed before and after 6 and 12 months of DS 3 . The clinical active phase was characterized by the CDAI score (Crohn's Disease Activity Index) and the fecal calprotectin assay. The 25OHD 3  profile was analyzed by LC-MS/MS. The pro-inflammatory cytokines (TNFα, IL-6, IL-12, IL-17, IL-23) were assessed by ELISA tests. The serum trace elements (Se, Mn, Cu, Zn) was determined by mass spectrometry. The antioxidant status (TAS, SOD, GPx, GSH) was evaluated by Randox kits. The results showed that the serum 25OHD 3  concentrations became normal (> 75 nmol/L or > 30 ng/mL) in the 2 groups. Our data showed that vitamin D supplementation allowed the clinical remission phase. The DS3 decreased serum levels of CRPus, TNFα, IL-17 and IL-23. The DS3 modulates the trace elements ratio and increased the SOD and GPx activities. The DS3 corrects the denutrition state. The vitamin D supplementation benefits are more significant in D 6  group (continuous 6,000 IU/day) than in D 200  group (intermittent 200,000 IU/month). Our study suggests that the serum 25OHD 3  profile can be considered a reliable biomarker in the bioclinic CD evolution to prevent the active phase, to extend the remission phase and to avoid the surgical bowel resection.",2022,"The DS3 decreased serum levels of CRPus, TNFα, IL-17 and IL-23.","['262\xa0CD patients and vitamin', '30', ""Crohn's disease (CD"", ""Crohn's disease patients""]","['oral vitamin D 3  supplementation', 'vitamin\xa0D supplementation', 'vitamin\xa0D 3  supplementation (DS 3 ']","['antioxidant status (TAS, SOD, GPx, GSH', '25-hydroxyvitamin D 3  (25OHD 3 ) deficiency', 'Serum 25OHD 3  levels', 'serum 25OHD 3  concentrations became normal', 'SOD and GPx activities', 'serum levels of CRPus, TNFα, IL-17 and IL-23', ""CDAI score (Crohn's Disease Activity Index) and the fecal calprotectin assay"", 'serum trace elements (Se, Mn, Cu, Zn']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}]",,0.248671,"The DS3 decreased serum levels of CRPus, TNFα, IL-17 and IL-23.","[{'ForeName': 'Naziha', 'Initials': 'N', 'LastName': 'Berriche-Yahi', 'Affiliation': 'Équipe de bioénergétique et métabolisme intermédiaire, LBPO, FSB, Université des Sciences et de la technologie Houari Boumediene, Alger, Algérie, Service de chirurgie infantile, CHU de Beni Messous, Alger, Algérie.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Tahar', 'Affiliation': 'Équipe de bioénergétique et métabolisme intermédiaire, LBPO, FSB, Université des Sciences et de la technologie Houari Boumediene, Alger, Algérie.'}, {'ForeName': 'Hocine', 'Initials': 'H', 'LastName': 'Asselah', 'Affiliation': ""Service d'hépato-gastroentérologie, CHU de Bologhine, Alger, Algérie.""}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Ayoub', 'Affiliation': 'Service de médecine interne, CHU de Beni Messous, Alger, Algérie.'}, {'ForeName': 'Djaffar', 'Initials': 'D', 'LastName': 'Hantala', 'Affiliation': 'Service de chirurgie infantile, CHU de Beni Messous, Alger, Algérie.'}, {'ForeName': 'Elhadj-Ahmed', 'Initials': 'EA', 'LastName': 'Koceir', 'Affiliation': 'Équipe de bioénergétique et métabolisme intermédiaire, LBPO, FSB, Université des Sciences et de la technologie Houari Boumediene, Alger, Algérie.'}]",Annales de biologie clinique,['10.1684/abc.2021.1698']
1891,35120436,A randomized controlled clinical trial of prolonged balloon inflation during stent deployment strategy in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a pilot study.,"BACKGROUND


Primary percutaneous coronary intervention (PPCI) is the standard procedure for reperfusion for ST-segment elevation myocardial infarction (STEMI), but the occurrence of the no-reflow phenomenon remains common and is associated with adverse outcomes.
AIMS


This study aimed to evaluate whether prolonged balloon inflation in stent deployment would lessen the occurrence of the no-reflow phenomenon in PPCI compared with conventional rapid inflation/deflation strategy.
METHODS


Patients were randomly assigned to either the prolonged balloon inflation in stent deployment group (PBSG) or conventional deployment strategy group (CDSG) in a 1:1 ratio. A subset of patients was included in the cardiac magnetic resonance (CMR) assessment.
RESULTS


Thrombolysis in MI (TIMI) flow grade 3 was found in 96.7% and 63.3% of the patients of the PBSG and CDSG, respectively (P = 0.005). The results of the PBSG and CDSG are respectively shown as follows: 0% versus 30% no-reflow or slow flow (P = 0.002); 90% versus 66.7% ST-segment resolution ≥ 50% (P = 0.028); 35.6 ± 14.5 frames versus 49.18 ± 25.2 frames on corrected TIMI frame count (P = 0.014); and 60% versus 20% myocardial blush grade 3 (P = 0.001). At 1 month, the major cardiovascular adverse event (cardiovascular mortality) rate was 3.3% in both groups; at 1 year, the rate was 3.3% and 6.7% for the PBSG and CDSG, respectively (P = 1.00). In the CMR subset of cases, the presence of microvascular obstruction (MVO) was detected in 6.7% and 50% of the patients in the PBSG and CDSG, respectively (P = 0.023).
CONCLUSION


In our pilot trial, prolonged balloon inflation during stent deployment strategy in PPCI reduces the occurrence of the no-reflow phenomenon in patients with STEMI and improved the myocardial microcirculation perfusion (ClinicalTrials.gov number: NCT03199014; registered: 26/June/2017).",2022,"At 1 month, the major cardiovascular adverse event (cardiovascular mortality) rate was 3.3% in both groups; at 1 year, the rate was 3.3% and 6.7% for the PBSG and CDSG, respectively (P = 1.00).","['primary percutaneous coronary intervention for ST-segment elevation myocardial infarction', 'Patients']","['percutaneous coronary intervention (PPCI', 'prolonged balloon inflation', 'prolonged balloon inflation in stent deployment group (PBSG) or conventional deployment strategy group (CDSG']","['cardiac magnetic resonance (CMR) assessment', 'corrected TIMI frame count', 'myocardial microcirculation perfusion', 'major cardiovascular adverse event (cardiovascular mortality) rate', 'microvascular obstruction (MVO', 'MI (TIMI) flow grade 3']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",,0.102888,"At 1 month, the major cardiovascular adverse event (cardiovascular mortality) rate was 3.3% in both groups; at 1 year, the rate was 3.3% and 6.7% for the PBSG and CDSG, respectively (P = 1.00).","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, West China Hospital, Sichuan University, No. 37 GuoXueXiang, Chengdu, 610041, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Mian Yang People's Hospital, Chengdu, China.""}, {'ForeName': 'Kai-Yue', 'Initials': 'KY', 'LastName': 'Diao', 'Affiliation': 'Department of Radiology, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, No. 37 Guoxue Street, Chengdu, 610041, China.'}, {'ForeName': 'Shi-Chu', 'Initials': 'SC', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, West China Hospital, Sichuan University, No. 37 GuoXueXiang, Chengdu, 610041, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiology, West China Hospital, Sichuan University, No. 37 GuoXueXiang, Chengdu, 610041, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, West China Hospital, Sichuan University, No. 37 GuoXueXiang, Chengdu, 610041, China.'}, {'ForeName': 'Mian', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, West China Hospital, Sichuan University, No. 37 GuoXueXiang, Chengdu, 610041, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, West China Hospital, Sichuan University, No. 37 GuoXueXiang, Chengdu, 610041, China.'}, {'ForeName': 'Zhi-Gang', 'Initials': 'ZG', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, No. 37 Guoxue Street, Chengdu, 610041, China. yangzg666@163.com.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, West China Hospital, Sichuan University, No. 37 GuoXueXiang, Chengdu, 610041, China. heyong_huaxi@163.com.'}]",BMC cardiovascular disorders,['10.1186/s12872-022-02477-0']
1892,35121062,"Preoperative fasting for the infusion of ""yerba mate"": a randomized clinical trial with ultrasound evaluation of gastric contents.","BACKGROUND


The traditional infusion of ""yerba mate"" is widely consumed in South America and exported to countries around the world. Although generally considered a ""clear fluid"", there is no data to date on the gastric emptying time of yerba mate and safe preoperative fasting intervals. The objective of this study was to evaluate the gastric emptying time of a standardized infusion of yerba mate using bedside ultrasound and compare it with the time confirm of hot and cold tea.
METHODS


This was a prospective, randomized crossover experimental study. Thirty healthy volunteers were evaluated after 8 hours of fasting for both fluids and solids. Gastric antral area and gastric volume were evaluated at baseline and every 20 minutes after drinking 300 mL of randomly assigned infusion of ""yerba mate"", hot tea, or cold tea.
RESULTS


The mean gastric emptying time was: 69.7 ± 22.1 min, 63.1 ± 14.5 min, and 64.3 ± 23.5 min for the mate, hot tea, and cold tea respectively. No significant differences were found in emptying time among the infusion groups (p-value = 0.043). When same time measures were compared, the only significant difference detected was between hot teas and mate infusion at 20 minutes (p-value = 0.012) CONCLUSION: Yerba mate infusion has a similar gastric emptying time to that of tea. All subject's gastric volume returned to baseline values by 100 minutes. It is reasonable to recommend a similar fasting period of 2 hours for mate infusion prior to elective surgery.",2022,No significant differences were found in emptying time among the infusion groups (p-value = 0.043).,['Thirty healthy volunteers'],"['yerba mate"", hot tea, or cold tea', 'hot and cold tea']","['mean gastric emptying time', 'emptying time', 'gastric emptying time', 'Gastric antral area and gastric volume']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0874159', 'cui_str': 'Mate, Yerba'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",30.0,0.0338461,No significant differences were found in emptying time among the infusion groups (p-value = 0.043).,"[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Alcarraz', 'Affiliation': 'Facultad de Medicina UDELAR, Hospital de Clínicas ""Dr. Manuel Quintela"", Departmento de Anestesiología, Montevideo, Uruguay. Electronic address: palcarraz@gmail.com.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Servente', 'Affiliation': 'Facultad de Medicina UDELAR, Hospital de Clínicas ""Dr. Manuel Quintela"", Departmento Clínico de Imagenología, Montevideo, Uruguay.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Kuster', 'Affiliation': 'Facultad de Medicina UDELAR, Hospital de Clínicas ""Dr. Manuel Quintela"", Departmento de Anestesiología, Montevideo, Uruguay.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Duarte', 'Affiliation': 'Facultad de Medicina UDELAR, Hospital de Clínicas ""Dr. Manuel Quintela"", Departmento de Anestesiología, Montevideo, Uruguay.'}, {'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Garau', 'Affiliation': 'Facultad de Medicina UDELAR, Departmento de Métodos Cuantitativos, Montevideo, Uruguay.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Desirello', 'Affiliation': 'Facultad de Medicina UDELAR, Hospital de Clínicas ""Dr. Manuel Quintela"", Departmento Clínico de Imagenología, Montevideo, Uruguay.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Blanc', 'Affiliation': 'Facultad de Medicina UDELAR, Laboratorio de Radiobiología Departmento Biofísica, Montevideo, Uruguay.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Bracesco', 'Affiliation': 'Facultad de Medicina UDELAR, Laboratorio de Radiobiología Departmento Biofísica, Montevideo, Uruguay.'}, {'ForeName': 'Anahi', 'Initials': 'A', 'LastName': 'Perlas', 'Affiliation': 'University Health Network and University of Toronto, Toronto Western Hospital, Department of Anesthesia, Toronto, Canada.'}]",Brazilian journal of anesthesiology (Elsevier),['10.1016/j.bjane.2021.12.010']
1893,35123362,A pilot feasibility study of a behavioral intervention for nicotine vaping cessation among young adults delivered via telehealth.,"BACKGROUND


Nicotine vaping among youth has increased, warranting concern from tobacco control proponents. Many youth who vape indicate interest in quitting; however, few empirically supported vaping cessation interventions exist. This pilot feasibility study adapted an established behavioral intervention, contingency management (CM), delivered via telehealth to promote vaping cessation among young adults.
METHODS


Participants (N = 27; ages 17-21) vaping nicotine regularly were recruited via social media and digital advertisements from across the US (June 2020-January 2021). Participants were randomized at approximately 4:1 to CM or Monitoring control (22:5). CM was delivered through DynamiCare Health's smartphone app for 4 weeks, in which financial incentives were delivered contingent on abstinent cotinine samples after the quit day until the end of treatment (EOT; Days 7-28; 10 expected submissions). Control participants earned incentives for submitting cotinine, regardless of abstinence. Feasibility, acceptability, and abstinence was collected throughout treatment, at EOT, and at 1-month follow-up.
RESULTS


The majority of enrolled participants completed treatment (Monitoring: 5/5; CM: 20/22), and intervention components were rated favorably overall (> 80%). CM participants submitted 112/220 (55%) abstinent cotinine samples throughout the quit attempt, while the Monitoring group submitted 4/50 (8%) negative samples. There were no differences in abstinence between groups at EOT or follow-up.
CONCLUSION


This pilot study of a telehealth-based youth vaping cessation intervention demonstrated preliminary feasibility and acceptability. These results suggest that CM for young adult vaping cessation, delivered remotely, is a promising direction for future work and fully powered trials are warranted to assess intervention efficacy.",2022,"There were no differences in abstinence between groups at EOT or follow-up.
","['young adults delivered via telehealth', 'Participants (N\xa0=\xa027; ages 17-21) vaping nicotine regularly were recruited via social media and digital advertisements from across the US (June 2020-January 2021', 'young adults']","['telehealth-based youth vaping cessation intervention', 'established behavioral intervention, contingency management (CM), delivered via telehealth', 'behavioral intervention']","['Feasibility, acceptability, and abstinence']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.0530153,"There were no differences in abstinence between groups at EOT or follow-up.
","[{'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Palmer', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA; Department of Pulmonary, Critical Care, Allergy, and Sleep Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Squeglia', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA; Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dahne', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Toll', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA; Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA. Electronic address: mccluree@musc.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2022.109311']
1894,35123322,"Effects of 4G-beta-D-Galactosylsucrose in patients with depression: A randomized, double-blinded, placebo-controlled, parallel-group comparative study.","Advances in genetic research on microbiome have led to several trials on the effectiveness of synbiotics or probiotics in patients with depression; however, none have evaluated the efficacy of prebiotics. 4G-beta-D-Galactosylsucrose (Lactosucrose, LS) is selectively assimilated by Bifidobacterium as a prebiotic and improves microbiome diversity. However, as it is not clear if LS consumption can improve symptoms of depression, we investigated whether LS intake can improve depressive symptoms, quality of life (QOL), and self-efficacy by conducting a single cite, double-blinded, randomized controlled trial in 20 outpatients with depressive episodes (F32, ICD-10) for 24 weeks. Participants (age range, 36-72 years) were randomized to the LS (n = 9) or placebo groups (n = 11). Primary outcome was improvement in total Montgomery Asberg Depression Rating Scale (MADRS) score, and the secondary outcomes were MADRS subscores, global self-efficacy scale (GSES) score, World Health Organization QOL (WHO/QOL-26) score, and 16S rRNA analysis of the fecal microbiome. LS consumption did not significantly improve total MADRS scores (-2 (-16 to 16) vs 0 (-6 to 10), p = 0.552), but GSES tended to improve in the LS group (2.00 ± 4.24 vs -1.36 ± 4.15, p = 0.091) with a large effect size (Cohen's d = 0.802). Sequencing of 16S rRNA revealed individual-level differences in microbiome diversity changes due to the intervention. Thus, we show that LS intake can improve self-efficacy, but not depressive symptoms, even in a small sample. Additional studies that also regulate diet and ensure adherence may help determine a correlation between depression and the gut microbiome.",2022,LS consumption did not significantly improve total MADRS scores (-2 (,"['Participants (age range, 36-72 years', 'patients with depression', '20 outpatients with depressive episodes (F32, ICD-10) for 24 weeks']","['placebo', 'LS', '4G-beta-D-Galactosylsucrose', '4G-beta-D-Galactosylsucrose (Lactosucrose, LS']","['total Montgomery Asberg Depression Rating Scale (MADRS) score, and the secondary outcomes were MADRS subscores, global self-efficacy scale (GSES) score, World Health Organization QOL (WHO/QOL-26) score, and 16S rRNA analysis of the fecal microbiome', 'depressive symptoms, quality of life (QOL), and self-efficacy', 'total MADRS scores', 'self-efficacy']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0217306', 'cui_str': 'galactosucrose'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}]",20.0,0.488545,LS consumption did not significantly improve total MADRS scores (-2 (,"[{'ForeName': 'Seiichiro', 'Initials': 'S', 'LastName': 'Tarutani', 'Affiliation': 'Department of Psychiatry, Shin-Abuyama Hospital, Osaka Institute of Clinical Psychiatry, 4-10-1, Nasahara, Takatsuki, Osaka, 569-1041, Japan. Electronic address: seiichirou.tarutani@ompu.ac.jp.'}, {'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Omori', 'Affiliation': ""Faculty of Human Life and Science, Doshisha Women's College, Teramachi Nishiiru, Imadegawa-dori, Kamigyo-ku, Kyoto, 602-0893, Japan; Department of Food Science and Nutrition, Faculty of Agriculture, Kinki University, 3327-204 Nakamachi, Nara, Nara, 631-8505, Japan. Electronic address: m-omori@nara.kindai.ac.jp.""}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Ido', 'Affiliation': ""Faculty of Health and Nutrition Baika Women's University, 2-19-5, Shukunosho, Ibaraki, Osaka, 567-0051, Japan; Department of Food and Nutrition, Faculty of Home Economies, Kyoto Women's University, 35 Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto, 605-8501, Japan. Electronic address: y-ido@baika.ac.jp.""}, {'ForeName': 'Megumu', 'Initials': 'M', 'LastName': 'Yano', 'Affiliation': ""Research Institute for Nutrition Sciences, Mukogawa Women's University, 6-46, Ikebiraki, Nishinomiya, Hyogo, 663-8558, Japan. Electronic address: m_yano@mukogawa-u.ac.jp.""}, {'ForeName': 'Tatsushi', 'Initials': 'T', 'LastName': 'Komatsu', 'Affiliation': ""Faculty of Human Life and Science, Doshisha Women's College, Teramachi Nishiiru, Imadegawa-dori, Kamigyo-ku, Kyoto, 602-0893, Japan. Electronic address: tkomatsu@dwc.doshisha.ac.jp.""}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Okamura', 'Affiliation': 'Department of Psychiatry, Shin-Abuyama Hospital, Osaka Institute of Clinical Psychiatry, 4-10-1, Nasahara, Takatsuki, Osaka, 569-1041, Japan. Electronic address: okamura@shin-abuyama.or.jp.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2022.01.059']
1895,35123290,Dialectical behavior therapy skills training for individuals with multiple sclerosis and their support partners: A pilot randomized controlled trial.,"BACKGROUND


Symptoms of anxiety, depression, and emotion dysregulation are common among individuals with MS and their support partners. Dialectical behavior therapy (DBT) - a type of cognitive behavioral intervention - may be a promising treatment for individuals affected by MS. This pilot randomized controlled trial (RCT) assessed the effects and feasibility of remotely delivered DBT skills on anxiety and depression symptoms and emotion dysregulation in individuals with MS and their support partners.
METHODS


This study featured a single-masked, two-arm, parallel group design. Twenty pairs of individuals with MS and their support partners (n = 40) were randomized to 12 weeks of DBT or facilitated peer support (FPS). Masked assessments were completed at weeks 0 (baseline), 13 (post-intervention), and 26 (follow-up).
RESULTS


At post-intervention (primary endpoint), participants randomized to DBT exhibited significantly greater reductions in anxiety and depression symptoms compared to FPS (B = 4.45, p = .04, Cohen's d = 0.57). Secondary outcomes of emotion dysregulation and well-being favored the DBT group but did not reach statistical significance (ds = 0.51, ps = 0.07). Effects were not maintained at follow-up. Most (86%) individuals screened were eligible for the trial, and retention (70%) did not differ between study arms.
CONCLUSIONS


This pilot RCT provides encouraging evidence that DBT skills is feasible and may improve depression, anxiety, and emotion dysregulation for individuals with MS and their support partners. Future research is needed to optimize maintenance of DBT skills, investigate mechanisms for these improvements, and replicate these promising effects in a fully powered trial.",2022,"At post-intervention (primary endpoint), participants randomized to DBT exhibited significantly greater reductions in anxiety and depression symptoms compared to FPS (B = 4.45, p = .04, Cohen's d = 0.57).","['individuals with multiple sclerosis and their support partners', 'individuals affected by MS', 'individuals with MS and their support partners', 'Twenty pairs of individuals with MS and their support partners (n\xa0', 'Most (86%) individuals screened were eligible for the trial, and retention (70%) did not differ between study arms']","['remotely delivered DBT skills', 'DBT', 'Dialectical behavior therapy (DBT', 'DBT or facilitated peer support (FPS', 'Dialectical behavior therapy skills training']","['anxiety and depression symptoms and emotion dysregulation', 'emotion dysregulation and', 'depression, anxiety, and emotion dysregulation', 'anxiety and depression symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",40.0,0.06741,"At post-intervention (primary endpoint), participants randomized to DBT exhibited significantly greater reductions in anxiety and depression symptoms compared to FPS (B = 4.45, p = .04, Cohen's d = 0.57).","[{'ForeName': 'Abbey J', 'Initials': 'AJ', 'LastName': 'Hughes', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Address: 600N Wolfe St, Phipps Rm 174, Baltimore, MD 21287, USA. Electronic address: abbeyjhughes@jhmi.edu.'}, {'ForeName': 'Yevgeny', 'Initials': 'Y', 'LastName': 'Botanov', 'Affiliation': 'Department of Psychology, Pennsylvania State University - York, Address: 1031 Edgecomb Ave, Grumbacher ISTC Room 220, York, PA 17403, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Beier', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Address: 600N Wolfe St, Phipps Rm 174, Baltimore, MD 21287, USA.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.103481']
1896,35124433,Impact of cognitive remediation on the prediction of employment outcomes in severe mental illness.,"OBJECTIVE


Cognitive functioning is a potent predictor of work in people with a severe mental illness, including those receiving vocational services. Cognitive remediation has been shown to improve cognitive functioning and work outcomes in people receiving vocational services. However, it is unknown whether it reduces the strength of cognitive functioning as a predictor of work outcomes compared to people receiving vocational services alone.
METHOD


Data were pooled from five randomized controlled trials evaluating the effects of adding cognitive remediation to vocational rehabilitation vs. vocational services alone. A battery of baseline cognitive functioning measures was examined to identify predictors of competitive work outcomes over the following two years. Study condition (i.e., receipt of cognitive remediation) was included in the analyses to evaluate whether cognitive functioning was a weaker predictor of work outcomes in people receiving cognitive remediation compared to those receiving vocational services alone.
RESULTS


Cognitive functioning was a stronger predictor of wages earned and weeks worked in participants receiving vocational services alone than those who also received cognitive remediation. Cognitive functioning did not predict job acquisition in either study condition.
CONCLUSION


Cognitive remediation may improve employment outcomes in people receiving vocational services in part by reducing the adverse effects of impaired cognitive functioning on work performance.",2022,"RESULTS


Cognitive functioning was a stronger predictor of wages earned and weeks worked in participants receiving vocational services alone than those who also received cognitive remediation.","['people with a severe mental illness', 'people receiving vocational services', 'people receiving cognitive remediation compared to those receiving vocational services alone', 'severe mental illness']","['Cognitive remediation', 'cognitive remediation', 'cognitive remediation to vocational rehabilitation vs. vocational services alone']","['employment outcomes', 'Cognitive functioning']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0034996', 'cui_str': 'Vocational rehabilitation'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.0938204,"RESULTS


Cognitive functioning was a stronger predictor of wages earned and weeks worked in participants receiving vocational services alone than those who also received cognitive remediation.","[{'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'McGurk', 'Affiliation': 'Center for Psychiatric Rehabilitation, Boston University, 940 Commonwealth Avenue West, Boston, MA 02215, United States of America; Departments of Occupational Therapy and Psychological and Brain Sciences, Boston University, United States of America. Electronic address: mcgurk@bu.edu.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Departments of Biomedical Data Sciences and Community and Family Medicine, Geisel School of Medicine at Dartmouth, United States of America.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Bond', 'Affiliation': 'Westat Inc., United States of America.'}, {'ForeName': 'Kim T', 'Initials': 'KT', 'LastName': 'Mueser', 'Affiliation': 'Center for Psychiatric Rehabilitation, Boston University, 940 Commonwealth Avenue West, Boston, MA 02215, United States of America; Departments of Occupational Therapy and Psychological and Brain Sciences, Boston University, United States of America.'}]",Schizophrenia research,['10.1016/j.schres.2022.01.011']
1897,35124400,Remembering Molly: Immediate and delayed false memory formation after acute MDMA exposure.,"The entactogen 3,4-Methylenedioxymethamphetamine (MDMA) is increasingly being recognized for its therapeutic potential but is also widespread in nightlife settings where it may co-occur with crime. Since previous research detected impaired verbal memory during acute MDMA intoxication, understanding the drug's ramifications in an applied legal context becomes crucial. We conducted a double-blind, placebo-controlled trial to examine acute and delayed effects of MDMA (75 mg) on false memory in 60 healthy volunteers with a history of MDMA use, using three well-established false memory methods: a basic, associative word list (Deese/Roediger-McDermott (DRM)) paradigm and two applied misinformation tasks using a virtual reality crime. Memory was tested immediately (encoding and retrieval under drug influence) and 1 week later (retrieval when sober). Small MDMA-induced impairments of true memory in the word list task were detected at both time points. MDMA increased false memory for related but non-critical lures during the immediate test, and decreased false memory for critical lures after a delay. Episodic memory assessed in the misinformation tasks was not consistently affected. Findings indicate a complex memory profile but no heightened vulnerability to external suggestion in response to MDMA intoxication. Recommendations for future applied legal psychological research include adding measures of recall on top of recognition, using study designs that separate the different memory phases, and potentially testing higher doses. Further research on false memories and suggestibility using imagination procedures can also be relevant for the clinical context.",2022,"MDMA increased false memory for related but non-critical lures during the immediate test, and decreased false memory for critical lures after a delay.","['60 healthy volunteers with a history of MDMA use, using three well-established false memory methods: a basic']","['placebo', 'MDMA', '3,4-Methylenedioxymethamphetamine (MDMA', 'associative word list (Deese/Roediger-McDermott (DRM)) paradigm and\xa0two\xa0applied misinformation\xa0tasks using a virtual\xa0reality crime']",['Episodic memory'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0561845', 'cui_str': 'False memories'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0079843', 'cui_str': 'Misinformation'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0010325', 'cui_str': 'Crime'}]","[{'cui': 'C0561843', 'cui_str': 'Episodic memory'}]",60.0,0.0283853,"MDMA increased false memory for related but non-critical lures during the immediate test, and decreased false memory for critical lures after a delay.","[{'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Kloft', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, the Netherlands. Electronic address: l.kloft@maastrichtuniversity.nl.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Otgaar', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, the Netherlands; Faculty of Law, Catholic University of Leuven, Belgium.'}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Blokland', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, the Netherlands.'}, {'ForeName': 'Stefan W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': 'Department of Forensic Toxicology, Institute of Legal Medicine, Goethe University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, the Netherlands. Electronic address: j.ramaekers@maastrichtuniversity.nl.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2022.01.005']
1898,35124395,Early- and subsequent- response of cognitive functioning in Alzheimer's disease: Individual-participant data from five pivotal randomized clinical trials of donepezil.,"The association between early improvement and subsequent change in cognition is unexamined in antidementia clinical trials. We aimed to examine the consequences of early-response to antidementia medication in Alzheimer's disease. Participant-level data were analyzed from five pivotal clinical trials of donepezil for Alzheimer's disease lasting up to 24 weeks (N = 1917). Early-response was based on Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) change scores under minus four from baseline to week six, otherwise classified non-response; then subgrouped by donepezil or placebo. The primary analysis tested the group differences in ADAS-Cog change from baseline for the interval after week six up to 24, based on a three-level mixed-effects model repeated measures (MMRM) model. Four models of increasing complexity were tested, and the most parsimonious model was examined in the primary analysis. The remaining models were tested in sensitivity analysis. In the analytic sample, 32.09% (N = 396/1234) of donepezil and 24.01% (N = 164/683) of placebo participants were classified as early responders, and 67.91% donepezil (N = 838/1234), 75.99% (N = 519/683) placebo participants were not. MMRM identified a statistically significant (P < 0.05) responder group effect. Marginal means (MM) demonstrated more improvement for the early responders (donepezil: MM = -4.13, 95% CI = -5.93, -2.32; placebo MM = 1.81, 95% CI = -4.12, 0.50), compared to non-early responders (donepezil MM = 0.05, 95% CI = -1.40, 1.51; placebo MM = 2.59, 95% CI = 0.99, 4.19). Results replicated in sensitivity analysis. Our results inform clinicians regarding the extent and consequences of early improvement in cognitive functioning and potentially contribute to treatment monitoring and the design of clinical trials for Alzheimer's disease.",2022,"Marginal means (MM) demonstrated more improvement for the early responders (donepezil: MM = -4.13, 95% CI = ","[""for Alzheimer's disease lasting up to 24 weeks"", ""Alzheimer's disease""]","['placebo', 'donepezil or placebo', 'donepezil']","[""Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) change scores"", 'ADAS-Cog change']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}]","[{'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.765853,"Marginal means (MM) demonstrated more improvement for the early responders (donepezil: MM = -4.13, 95% CI = ","[{'ForeName': 'Stephen Z', 'Initials': 'SZ', 'LastName': 'Levine', 'Affiliation': 'Department of Community Mental Health, University of Haifa, Haifa, Israel. Electronic address: slevine@univ.haifa.ac.il.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Goldberg', 'Affiliation': 'The Faculty of Industrial Engineering and Management, Technion - Israel Institute of Technology, Haifa, Israel. Electronic address: yairgo@technion.ac.il.'}, {'ForeName': 'Kazufumi', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Health Promotion and Human Behavior, Graduate School of Medicine/ School of Public Health, Kyoto University, Kyoto, Japan. Electronic address: yoshida.kazufumi.77s@st.kyoto-u.ac.jp.'}, {'ForeName': 'Myrto', 'Initials': 'M', 'LastName': 'Samara', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Technical University of Munich, School of Medicine, Munich, Germany; 3rd Department of Psychiatry, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece. Electronic address: samaramyrto@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cipriani', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, United Kingdom; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, United Kingdom. Electronic address: andrea.cipriani@psych.ox.ac.uk.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Iwatsubo', 'Affiliation': 'Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan. Electronic address: iwatsubo@m.u-tokyo.ac.jp.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Leucht', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Technical University of Munich, School of Medicine, Munich, Germany. Electronic address: stefan.leucht@tum.de.'}, {'ForeName': 'Toshiaki A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Department of Health Promotion and Human Behavior, Graduate School of Medicine/ School of Public Health, Kyoto University, Kyoto, Japan. Electronic address: furukawa@kuhp.kyoto-u.ac.jp.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2022.01.055']
1899,35121271,Using network intervention analysis to explore associations between participant expectations of and difficulties with cognitive behavioural therapy for insomnia and clinical outcome: A proof of principle study.,"BACKGROUND


Research about predictors of response to cognitive behaviour therapy for insomnia (CBT-I) is ongoing. We examined any whether pre-intervention expectations or post-intervention appraisals of difficulties in utilizing face to face (FtF) or digital (dCBT-I) versions of the therapy were associated with outcome.
METHODS


Self-rating data were extracted on 101 adult participants in a recent randomized controlled trial of FtF versus dCBT-I. Network intervention analyses were used to explore any associations between expectations of CBT-I at response at 9 weeks and between post-intervention ratings of difficulties, modality of therapy and response at 9-weeks and at 6-months.
RESULTS


Anticipated and actual difficulties in employing sleep restriction techniques predicted response in all network models. Modality of therapy played a more overt role in the 9-week outcome network, with FtF therapy more robustly associated with response. However, the direct association between FtF therapy and response was not found in the 6-month outcome network. Notable predictors of poor outcome at 9-weeks and 6-month follow-up were difficulties in accommodating CBT-I into work and daily routines and applying the rules of CBT-I.
CONCLUSIONS


This network intervention analysis highlights that self-confidence and ability in undertaking sleep restriction is a key active ingredient of CBT-I. Also, benefits and gains from access to the FtF version of this multi-component therapy were more apparent in the short than the longer term. However, it is important that findings from this proof of principle study are confirmed in further studies.",2022,"Modality of therapy played a more overt role in the 9-week outcome network, with FtF therapy more robustly associated with response.",['Self-rating data were extracted on 101 adult participants'],"['cognitive behavioural therapy', 'FtF versus dCBT', 'FtF therapy', 'pre-intervention expectations or post-intervention appraisals of difficulties in utilizing face to face (FtF) or digital (dCBT-I', 'cognitive behaviour therapy']",[],"[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}]",[],101.0,0.0555769,"Modality of therapy played a more overt role in the 9-week outcome network, with FtF therapy more robustly associated with response.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Scott', 'Affiliation': 'Institute of Neuroscience, Newcastle University, UK; Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway. Electronic address: jan.scott@newcastle.ac.uk.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Vedaa', 'Affiliation': 'Department of Health Promotion, Norwegian Institute of Public Health, Bergen, Norway; Department of Research & Innovation, Helse Fonna, HF, Haugesund, Norway; Haukeland University Hospital, Bjørgvin District Psychiatric Center, Bergen, Norway.'}, {'ForeName': 'Børge', 'Initials': 'B', 'LastName': 'Sivertsen', 'Affiliation': 'Department of Health Promotion, Norwegian Institute of Public Health, Bergen, Norway; Department of Research & Innovation, Helse Fonna, HF, Haugesund, Norway.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Langsrud', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway; Department of Research and Development, St. Olavs University Hospital, Trondheim, Norway.'}, {'ForeName': 'Havard', 'Initials': 'H', 'LastName': 'Kallestad', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway; Department of Research and Development, St. Olavs University Hospital, Trondheim, Norway.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2022.01.054']
1900,35121270,"Antenatal depression: Efficacy of a pre-post therapy study and repercussions in motor development of children during the first 18 months postpartum. Study: ""Pregnancy care, healthy baby"".","AIMS


To evaluate the efficacy of brief psychotherapeutic interventions of cognitive behavioral therapy to treat antenatal depression and verify the association between interventions and motor development of infants at 3 and 18 months of age.
METHODS


Pre-post-intervention study nested a randomized clinical trial, both of which are extracts from a population-based cohort study of a southern Brazilian city. The major depressive episode was measured through Mini Plus, the severity of depressive symptoms by BDI-II and motor development using Bayley-III and AIMS. The follow-ups occurred during the gestational period (T2) and at 3 (T3) and 18 months (T4) after delivery.
RESULTS


Data were analyzed from 336 women in the control group (not intervened) and 108 from the group of depressed women who received intervention for antenatal depression. The effectiveness of the interventions for a major depressive episode was around 80% for both models in the two follow-up stages (3 and 18 months postpartum). In addition, the children whose mothers received intervention presented 3.7 (95% CI 0.7-6.6) points higher in Bayley-III at 3 months old when compared to the children in the control group (p = 0.01). There was no difference between the two psychotherapy models tested, both being equally effective (p > 0.05).
CONCLUSIONS


We found that the brief psychotherapeutic interventions of cognitive behavioral therapy for gestational depression were effective in causing remission of the condition both in the short and long term, besides indirectly causing benefits also to the children, with regard to their motor development.",2022,The effectiveness of the interventions for a major depressive episode was around 80% for both models in the two follow-up stages (3 and 18 months postpartum).,"['336 women in the control group (not intervened) and 108 from the group of depressed women who received intervention for antenatal depression', 'children during the first 18 months postpartum', 'population-based cohort study of a southern Brazilian city', 'infants at 3 and 18 months of age']","['cognitive behavioral therapy', 'psychotherapeutic interventions']",['severity of depressive symptoms by BDI-II and motor development using Bayley-III and AIMS'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}]",336.0,0.037301,The effectiveness of the interventions for a major depressive episode was around 80% for both models in the two follow-up stages (3 and 18 months postpartum).,"[{'ForeName': 'Ricardo Tavares', 'Initials': 'RT', 'LastName': 'Pinheiro', 'Affiliation': 'Catholic University of Pelotas, Brazil. Electronic address: ricardop@terra.com.br.'}, {'ForeName': 'Luciano Dias de Mattos', 'Initials': 'LDM', 'LastName': 'Souza', 'Affiliation': 'Catholic University of Pelotas, Brazil.'}, {'ForeName': 'Jéssica Puchalski', 'Initials': 'JP', 'LastName': 'Trettim', 'Affiliation': 'Catholic University of Pelotas, Brazil.'}, {'ForeName': 'Mariana Bonati', 'Initials': 'MB', 'LastName': 'de Matos', 'Affiliation': 'Catholic University of Pelotas, Brazil.'}, {'ForeName': 'Karen Amaral Tavares', 'Initials': 'KAT', 'LastName': 'Pinheiro', 'Affiliation': 'Federal University of Rio Grande, Brazil.'}, {'ForeName': 'Gabriela Kurz', 'Initials': 'GK', 'LastName': 'da Cunha', 'Affiliation': 'Catholic University of Pelotas, Brazil.'}, {'ForeName': 'Bárbara Borges', 'Initials': 'BB', 'LastName': 'Rubin', 'Affiliation': 'Catholic University of Pelotas, Brazil.'}, {'ForeName': 'Carolina Coelho', 'Initials': 'CC', 'LastName': 'Scholl', 'Affiliation': 'Catholic University of Pelotas, Brazil.'}, {'ForeName': 'Rafaelle Stark', 'Initials': 'RS', 'LastName': 'Stigger', 'Affiliation': 'Catholic University of Pelotas, Brazil.'}, {'ForeName': 'Janaína Vieira Dos Santos', 'Initials': 'JVDS', 'LastName': 'Motta', 'Affiliation': 'Federal University of Pelotas, Brazil.'}, {'ForeName': 'Sandro Schreiber', 'Initials': 'SS', 'LastName': 'de Oliveira', 'Affiliation': 'Catholic University of Pelotas, Brazil.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Ghisleni', 'Affiliation': 'Catholic University of Pelotas, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Nedel', 'Affiliation': 'Catholic University of Pelotas, Brazil.'}, {'ForeName': 'Luciana de Avila', 'Initials': 'LA', 'LastName': 'Quevedo', 'Affiliation': 'Catholic University of Pelotas, Brazil.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2022.01.061']
1901,35123694,"Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial.","BACKGROUND


Low-grade serous carcinoma of the ovary or peritoneum is characterised by MAPK pathway aberrations and its reduced sensitivity to chemotherapy relative to high-grade serous carcinoma. We compared the MEK inhibitor trametinib to physician's choice standard of care in patients with recurrent low-grade serous carcinoma.
METHODS


This international, randomised, open-label, multicentre, phase 2/3 trial was done at 84 hospitals in the USA and UK. Eligible patients were aged 18 years or older with recurrent low-grade serous carcinoma and measurable disease, as defined by Response Evaluation Criteria In Solid Tumors version 1.1, had received at least one platinum-based regimen, but not all five standard-of-care drugs, and had received an unlimited number of previous regimens. Patients with serous borderline tumours or tumours containing low-grade serous and high-grade serous carcinoma were excluded. Eligible patients were randomly assigned (1:1) to receive either oral trametinib 2 mg once daily (trametinib group) or one of five standard-of-care treatment options (standard-of-care group): intravenous paclitaxel 80 mg/m 2  by body surface area on days 1, 8, and 15 of every 28-day cycle; intravenous pegylated liposomal doxorubicin 40-50 mg/m 2  by body surface area once every 4 weeks; intravenous topotecan 4 mg/m 2  by body surface area on days 1, 8, and 15 of every 28-day cycle; oral letrozole 2·5 mg once daily; or oral tamoxifen 20 mg twice daily. Randomisation was stratified by geographical region (USA or UK), number of previous regimens (1, 2, or ≥3), performance status (0 or 1), and planned standard-of-care regimen. The primary endpoint was investigator-assessed progression-free survival while receiving randomised therapy, as assessed by imaging at baseline, once every 8 weeks for 15 months, and then once every 3 months thereafter, in the intention-to-treat population. Safety was assessed in patients who received at least one dose of study therapy. This trial is registered with ClinicalTrials.gov, NCT02101788, and is active but not recruiting.
FINDINGS


Between Feb 27, 2014, and April 10, 2018, 260 patients were enrolled and randomly assigned to the trametinib group (n=130) or the standard-of-care group (n=130). At the primary analysis, there were 217 progression-free survival events (101 [78%] in the trametinib group and 116 [89%] in the standard-of-care group). Median progression-free survival in the trametinib group was 13·0 months (95% CI 9·9-15·0) compared with 7·2 months (5·6-9·9) in the standard-of-care group (hazard ratio 0·48 [95% CI 0·36-0·64]; p<0·0001). The most frequent grade 3 or 4 adverse events in the trametinib group were skin rash (17 [13%] of 128), anaemia (16 [13%]), hypertension (15 [12%]), diarrhoea (13 [10%]), nausea (12 [9%]), and fatigue (ten [8%]). The most frequent grade 3 or 4 adverse events in the standard-of-care group were abdominal pain (22 [17%]), nausea (14 [11%]), anaemia (12 [10%]), and vomiting (ten [8%]). There were no treatment-related deaths.
INTERPRETATION


Trametinib represents a new standard-of-care option for patients with recurrent low-grade serous carcinoma.
FUNDING


NRG Oncology, Cancer Research UK, Target Ovarian Cancer, and Novartis.",2022,"There were no treatment-related deaths.
","['patients with recurrent low-grade serous carcinoma', 'Eligible patients', 'Patients with serous borderline tumours or tumours containing low-grade serous and high-grade serous carcinoma', 'patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS', 'Eligible patients were aged 18 years or older with recurrent low-grade serous carcinoma and measurable disease, as defined by Response Evaluation Criteria', '84 hospitals in the USA and UK', 'Between Feb 27, 2014, and April 10, 2018, 260 patients were enrolled and randomly assigned to the trametinib group (n=130) or the standard-of-care group (n=130']","['Trametinib versus standard of care', 'pegylated liposomal doxorubicin 40-50 mg/m 2  by body surface area once every 4 weeks; intravenous topotecan', 'letrozole 2·5 mg once daily; or oral tamoxifen', ""MEK inhibitor trametinib to physician's choice standard of care"", 'oral trametinib 2 mg once daily (trametinib group) or one of five standard-of-care treatment options (standard-of-care group): intravenous paclitaxel 80 mg/m 2  by body surface area']","['hypertension', 'skin rash', 'diarrhoea', 'abdominal pain', 'investigator-assessed progression-free survival', 'vomiting', 'nausea', 'Safety', '217 progression-free survival events', 'anaemia', 'Median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C3839184', 'cui_str': 'Low grade serous carcinoma'}, {'cui': 'C0334355', 'cui_str': 'Serous cystadenoma, borderline malignancy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C3839280', 'cui_str': 'High grade serous carcinoma'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C2347168', 'cui_str': 'Mitogen-activated protein kinase kinase inhibitor'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C3644516', 'cui_str': 'trametinib 2 MG'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",260.0,0.222384,"There were no treatment-related deaths.
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Gershenson', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: dgershen@mdanderson.org.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Brady', 'Affiliation': 'NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Carty', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Rodgers', 'Affiliation': 'New York Presbyterian/Queens, Department of Pathology, Weill Medical College of Cornell University, Flushing, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Millan', 'Affiliation': 'Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': 'Stephenson Cancer Center at the University of Oklahoma, Oklahoma City, OK, USA.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'The Royal Marsden Hospital NHS Foundation Trust, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Connolly', 'Affiliation': 'Edinburgh Cancer Centre, Edinburgh, UK.'}, {'ForeName': 'Angeles Alvarez', 'Initials': 'AA', 'LastName': 'Secord', 'Affiliation': 'Duke Cancer Institute, Durham, NC, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'The Ohio State University and the James Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Dorigo', 'Affiliation': 'Stanford Cancer Institute, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gaillard', 'Affiliation': 'Johns Hopkins Sidney Kimmel Cancer Center, Baltimore, MD, USA.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Gabra', 'Affiliation': 'Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Slomovitz', 'Affiliation': 'Division ofGynecologic Oncology, Mount Sinai Medical Center, Miami Beach, FL, USA.'}, {'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Hanjani', 'Affiliation': 'Abington Memorial Hospital, Abington, PA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Farley', 'Affiliation': ""St Joseph's Hospital and Medical Center, Phoenix, AZ, USA.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Churchman', 'Affiliation': 'Nicola Murray Centre for Ovarian Cancer Research, Institute of Genetics and Cancer, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Ailith', 'Initials': 'A', 'LastName': 'Ewing', 'Affiliation': 'MRC Human Genetics Unit and CRUK Edinburgh Centre, MRC Institute of Genetics and Cancer, University of Edinburgh, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Hollis', 'Affiliation': 'Nicola Murray Centre for Ovarian Cancer Research, Institute of Genetics and Cancer, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'C Simon', 'Initials': 'CS', 'LastName': 'Herrington', 'Affiliation': 'Nicola Murray Centre for Ovarian Cancer Research, Institute of Genetics and Cancer, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Helen Q', 'Initials': 'HQ', 'LastName': 'Huang', 'Affiliation': 'NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.'}, {'ForeName': 'Lari', 'Initials': 'L', 'LastName': 'Wenzel', 'Affiliation': 'Medicine and Public Health, University of California at Irvine, Irvine, CA, USA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Gourley', 'Affiliation': 'Nicola Murray Centre for Ovarian Cancer Research, Institute of Genetics and Cancer, Western General Hospital, Edinburgh, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(21)02175-9']
1902,35125128,"Family child care home providers' self-reported nutrition and physical activity practices, self-efficacy, barriers and knowledge: baseline findings from happy healthy homes.","OBJECTIVE


Describe nutrition and physical activity practices, nutrition self-efficacy and barriers and food programme knowledge within Family Child Care Homes (FCCH) and differences by staffing.
DESIGN


Baseline, cross-sectional analyses of the Happy Healthy Homes randomised trial (NCT03560050).
SETTING


FCCH in Oklahoma, USA.
PARTICIPANTS


FCCH providers (n 49, 100 % women, 30·6 % Non-Hispanic Black, 2·0 % Hispanic, 4·1 % American Indian/Alaska Native, 51·0 % Non-Hispanic white, 44·2 ± 14·2 years of age. 53·1 % had additional staff) self-reported nutrition and physical activity practices and policies, nutrition self-efficacy and barriers and food programme knowledge. Differences between providers with and without additional staff were adjusted for multiple comparisons (P < 0·01).
RESULTS


The prevalence of meeting all nutrition and physical activity best practices ranged from 0·0-43·8 % to 4·1-16·7 %, respectively. Average nutrition and physical activity scores were 3·2 ± 0·3 and 3·0 ± 0·5 (max 4·0), respectively. Sum nutrition and physical activity scores were 137·5 ± 12·6 (max 172·0) and 48·4 ± 7·5 (max 64·0), respectively. Providers reported high nutrition self-efficacy and few barriers. The majority of providers (73·9-84·7 %) felt that they could meet food programme best practices; however, knowledge of food programme best practices was lower than anticipated (median 63-67 % accuracy). More providers with additional staff had higher self-efficacy in family-style meal service than did those who did not (P = 0·006).
CONCLUSIONS


Providers had high self-efficacy in meeting nutrition best practices and reported few barriers. While providers were successfully meeting some individual best practices, few met all. Few differences were observed between FCCH providers with and without additional staff. FCCH providers need additional nutrition training on implementation of best practices.",2022,"More providers with additional staff had higher self-efficacy in family style meal service than did those who did not (p=0.006).
","['Family Child Care Homes (FCCH', 'FCCH providers (n=49, 100% women, 30.6% Non-Hispanic Black, 2.0% Hispanic, 4.1% American Indian/Alaska Native, 51.0% Non-Hispanic white, 44.2±14.2 years of age', 'Happy Healthy Homes', 'FCCH in Oklahoma, United States', 'Family Child Care Home Providers']",['nutrition training'],"['Self-Reported Nutrition and Physical Activity Practices, Self-Efficacy, Barriers, and Knowledge', 'additional staff) self-reported nutrition and physical activity practices and policies, nutrition self-efficacy and barriers, and food program knowledge', 'Sum nutrition and physical activity scores', 'self-efficacy', 'Average nutrition and physical activity scores']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0028914', 'cui_str': 'Oklahoma'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.0663656,"More providers with additional staff had higher self-efficacy in family style meal service than did those who did not (p=0.006).
","[{'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Sisson', 'Affiliation': 'Department of Nutrition Sciences, University of Oklahoma Health Sciences Center, 1200 N Stonewall Ave, AHB 3057, Oklahoma City, OK73117-1215, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Eckart', 'Affiliation': 'Department of Biostatics and Epidemiology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Bethany D', 'Initials': 'BD', 'LastName': 'Williams', 'Affiliation': 'Department of Nutrition Sciences, University of Oklahoma Health Sciences Center, 1200 N Stonewall Ave, AHB 3057, Oklahoma City, OK73117-1215, USA.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Patel', 'Affiliation': 'Department of Nutrition Sciences, University of Oklahoma Health Sciences Center, 1200 N Stonewall Ave, AHB 3057, Oklahoma City, OK73117-1215, USA.'}, {'ForeName': 'Chelsea L', 'Initials': 'CL', 'LastName': 'Kracht', 'Affiliation': 'Department of Nutrition Sciences, University of Oklahoma Health Sciences Center, 1200 N Stonewall Ave, AHB 3057, Oklahoma City, OK73117-1215, USA.'}, {'ForeName': 'Holly A', 'Initials': 'HA', 'LastName': 'Davis', 'Affiliation': 'Department of Nutrition Sciences, University of Oklahoma Health Sciences Center, 1200 N Stonewall Ave, AHB 3057, Oklahoma City, OK73117-1215, USA.'}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'University of North Carolina Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Deana', 'Initials': 'D', 'LastName': 'Hildebrand', 'Affiliation': 'Oklahoma State University, Stillwater, OK, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Stoner', 'Affiliation': 'Department of Biostatics and Epidemiology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Stinner', 'Affiliation': 'Department of Nutrition Sciences, University of Oklahoma Health Sciences Center, 1200 N Stonewall Ave, AHB 3057, Oklahoma City, OK73117-1215, USA.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Kerr', 'Affiliation': 'Department of Nutrition Sciences, University of Oklahoma Health Sciences Center, 1200 N Stonewall Ave, AHB 3057, Oklahoma City, OK73117-1215, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Salvatore', 'Affiliation': 'Value Institute, ChristianaCare, Neward, DE, USA.'}]",Public health nutrition,['10.1017/S1368980022000337']
1903,35129242,"HIV clinic-based extended-release naltrexone versus treatment as usual for people with HIV and opioid use disorder: a non-blinded, randomized non-inferiority trial.","BACKGROUND AND AIM


Opioid agonist medications for treatment of opioid use disorder (OUD) can improve human immunodeficiency virus (HIV) outcomes and reduce opioid use. We tested whether outpatient antagonist treatment with naltrexone could achieve similar results.
DESIGN


Open-label, non-inferiority randomized trial.
SETTING


Six US HIV primary care clinics.
PARTICIPANTS


A total of 114 participants with untreated HIV and OUD (62% male; 56% black, 12% Hispanic; positive for fentanyl (62%), other opioids (47%) and cocaine (60%) at baseline). Enrollment halted early due to slow recruitment.
INTERVENTION


HIV clinic-based extended-release naltrexone (XR-NTX; n = 55) versus treatment as usual (TAU) with buprenorphine or methadone (TAU; n = 59).
MEASUREMENTS


Treatment group differences were compared for the primary outcome of viral suppression (HIV RNA ≤ 200 copies/ml) at 24 weeks and secondary outcomes included past 30-day use of opioids at 24 weeks.
FINDINGS


Fewer XR-NTX participants initiated medication compared with TAU participants (47 versus 73%). The primary outcome of viral suppression was comparable for XR-NTX (52.7%) and TAU (49.2%) [risk ratio (RR) = 1.064; 95% confidence interval (CI) = 0.748, 1.514] at 24 weeks. Non-inferiority could not be demonstrated, as the lower confidence limit of the RR did not exceed the pre-specified margin of 0.75 in intention-to-treat (ITT) analysis. The main secondary outcome of past 30-day opioid use was comparable for XR-NTX versus TAU (11.7 versus 14.8 days; mean difference = -3.1; 95% CI = -8.7, 1.1) in ITT analysis. Among those initiating medication, XR-NTX resulted in fewer days of opioid use compared with TAU in the past 30 days (6.0 versus 13.6, mean difference = -7.6; 95% CI = -13.8, -0.2).
CONCLUSIONS


A randomized controlled trial found supportive, but not conclusive, evidence that human immunodeficiency virus clinic-based extended-release naltrexone is not inferior to treatment as usual for facilitating human immunodeficiency virus viral suppression. Participants who initiated extended-release naltrexone used fewer opioids than those who received treatment as usual.",2022,"Among those initiating medication, XR-NTX resulted in fewer days of opioid use compared with TAU in the past 30 days (6.0 vs. 13.6, mean difference -7.6; 95% CI -13.8, -0.2).
","['Six U.S. HIV primary care clinics', 'People with HIV and Opioid Use Disorder', '114 participants with untreated HIV and OUD (62% male; 56% Black, 12% Hispanic; positive for fentanyl (62%), other opioids (47%), and cocaine (60%) at baseline']","['HIV Clinic-Based Extended Release Naltrexone', 'buprenorphine or methadone (TAU; n=59', 'HIV clinic-based extended-release naltrexone (XR-NTX', 'naltrexone']","['viral suppression', 'XR-NTX', 'past 30-day opioid use']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C3539175', 'cui_str': 'Other opioids'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",114.0,0.691939,"Among those initiating medication, XR-NTX resulted in fewer days of opioid use compared with TAU in the past 30 days (6.0 vs. 13.6, mean difference -7.6; 95% CI -13.8, -0.2).
","[{'ForeName': 'P Todd', 'Initials': 'PT', 'LastName': 'Korthuis', 'Affiliation': 'Addiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Ryan R', 'Initials': 'RR', 'LastName': 'Cook', 'Affiliation': 'Addiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Lum', 'Affiliation': 'Division of HIV, ID and Global Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Elizabeth Needham', 'Initials': 'EN', 'LastName': 'Waddell', 'Affiliation': 'Addiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Hansel', 'Initials': 'H', 'LastName': 'Tookes', 'Affiliation': 'Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Vergara-Rodriguez', 'Affiliation': 'Ruth M. Rothstein CORE Center, Department of Psychiatry and Department of Internal Medicine, Cook County Health, Chicago, IL, USA.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Kunkel', 'Affiliation': 'Addiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Lucas', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Allan E', 'Initials': 'AE', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Sarann', 'Initials': 'S', 'LastName': 'Bielavitz', 'Affiliation': 'Addiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Fanucchi', 'Affiliation': 'Division of Infectious Diseases and Center on Drug and Alcohol Research, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Hoffman', 'Affiliation': 'Oregon Health and Science University-Portland State University School of Public Health, Portland, OR, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Bachrach', 'Affiliation': 'Tarzana Treatment Centers, Tarzana, CA, USA.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Payne', 'Affiliation': 'Emmes Company, LLC, Rockville, MD, USA.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Collins', 'Affiliation': 'Emmes Company, LLC, Rockville, MD, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Matthews', 'Affiliation': 'Emmes Company, LLC, Rockville, MD, USA.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Oden', 'Affiliation': 'Emmes Company, LLC, Rockville, MD, USA.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Jacobs', 'Affiliation': 'National Institutes of Health, National Institute on Aging, Bethesda, MD, USA.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Jelstrom', 'Affiliation': 'Emmes Company, LLC, Rockville, MD, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Sorensen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'McCarty', 'Affiliation': 'Addiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15836']
1904,35121105,Subcutaneous Gammanorm® by pump or rapid push infusion: Impact of the device on quality of life in adult patients with primary immunodeficiencies.,"Many patients with immunodeficiencies require lifelong immunoglobulin replacement therapy (IgRT). In a multicenter, randomized, open-label, crossover, non-inferiority 3-month-trial, we compared the impact of the subcutaneous immunoglobulin Gammanorm® administered via pump or syringe (rapid push). Primary endpoint was the life quality index (LQI), secondary endpoints were QoL (SF36v2), satisfaction (TSQM-11), disease and treatment burden (PRISM), incidence of infections and adverse events (AE), treatment costs, and IgG levels. 28/30 patients completed the study. Most of the endpoints were comparable. Drug administrations with rapid push were more frequent, but reduced total time expenditure and some costs. Of the TSQM-11/LQI/SF36 components only ""treatment interference with daily activities"" was superior with pump and two QoL domains with rapid push. Both delivery devices showed favorable safety. Rapid push was preferred by 34.5% of patients. It proved to be an efficacious and cost-effective alternative to pumps adding to patient choice and increasing flexibility during long-term IgRT.",2022,"Of the TSQM-11/LQI/SF36 components only ""treatment interference with daily activities"" was superior with pump and two QoL domains with rapid push.","['Many patients with immunodeficiencies require lifelong immunoglobulin replacement therapy (IgRT', 'adult patients with primary immunodeficiencies', '28/30 patients completed the study']",['subcutaneous immunoglobulin Gammanorm® administered via pump or syringe (rapid push'],"['total time expenditure and some costs', 'favorable safety', 'quality of life', 'life quality index (LQI), secondary endpoints were QoL (SF36v2), satisfaction (TSQM-11), disease and treatment burden (PRISM), incidence of infections and adverse events (AE), treatment costs, and IgG levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021051', 'cui_str': 'Immunodeficiency disorder'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0398686', 'cui_str': 'Primary immune deficiency disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0580841', 'cui_str': 'Does push'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0732381,"Of the TSQM-11/LQI/SF36 components only ""treatment interference with daily activities"" was superior with pump and two QoL domains with rapid push.","[{'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Warnatz', 'Affiliation': 'Dept. of Rheumatology and Clinical Immunology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany; Center for Chronic Immunodeficiency (CCI), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany. Electronic address: klaus.warnatz@uniklinik-freiburg.de.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jolles', 'Affiliation': 'Immunodeficiency Centre for Wales, University Hospital of Wales, Cardiff CF14 4XW, UK.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Agostini', 'Affiliation': 'Hematology and Clinical Immunology Unit, Dept of Medicine, University of Padua, Veneto 35122, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Vianello', 'Affiliation': 'Hematology and Clinical Immunology Unit, Dept of Medicine, University of Padua, Veneto 35122, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Borte', 'Affiliation': 'Immuno Deficiency Center Leipzig (IDCL), Klinikum St. Georg, 04129 Leipzig, Germany.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bethune', 'Affiliation': 'Dept of Immunology and Allergy, University Hospital Plymouth NHS Trust, Plymouth PL6 8DH, UK.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Grigoriadou', 'Affiliation': 'Immunology Dept, Barts Health NHS Trust, The Royal London Hospital, London E1 2ES, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Richter', 'Affiliation': 'Dept of Immunology, University Hospitals Birmingham NHS Foundation Trust, Birmingham B15 2TH, UK.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Dept of Clinical Immunology, The John Radcliffe Hospital, Oxford OX3 9DU, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Lowe', 'Affiliation': 'Dept of Immunology, Royal Free London and UCL Institute of Immunity and Transplantation, Royal Free Campus, London NW3 2QG, UK.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Katelaris', 'Affiliation': 'Dept of Medicine, Immunology and Allergy, Campbelltown Hospital, Campbelltown, NSW 2560, Australia.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Milito', 'Affiliation': 'Dept of Molecular Medicine, ""Sapienza"" University of Rome, Lazio 00185, Italy.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Cook', 'Affiliation': 'Dept of Immunology, Canberra Hospital and Centre for Personalised Immunology, John Curtin School of Medical Research, Australian National University, Canberra 2601, Australia.'}]","Clinical immunology (Orlando, Fla.)",['10.1016/j.clim.2022.108938']
1905,35121091,"Does Nefopam Provide Analgesic Effect and Reduce Morphine Consumption After Primary Total Knee Arthroplasty? A Prospective, Double-Blind, Randomized Controlled Trial.","BACKGROUND


One of the most undesirable results after total knee arthroplasty (TKA) is severe immediate postoperative pain, resulting in patient dissatisfaction. We aimed to evaluate nefopam's analgesic efficacy after primary TKA along with related outcomes, including morphine consumption and adverse events.
METHODS


We conducted a double-blind, randomized controlled trial of patients undergoing unilateral primary TKA, comparing 24 hours of 80 mg of continuous intravenous nefopam to placebo infusion. A 100-mm Visual Analog Scale (VAS) for pain-at-rest and in-motion ≤48 hours was the primary outcome measure. Secondary outcomes were morphine and antiemetic consumption, adverse events, and functional outcomes: time-to-walk, timed up-and-go test, postoperative knee range of motion at 24 and 48 hours, time-to-discharge, and patient satisfaction scores.
RESULTS


Patients in the nefopam group had significantly lower VAS at rest 6 hours postop (20.3 ± 27.3 vs 35 ± 24.3, P = .01). Other timepoints and in-motion VAS did not significantly differ. Total morphine consumption (0-48 hours) was 37% less, significantly lower, in the nefopam group (5.3 ± 4.5 vs 8.4 ± 7.5 mg, P = .03). Antiemetic consumption was also 61% lower in the nefopam group but not statistically significant (0.8 ± 2.3 vs 2.0 ± 3.8 mg, P = .08). There were no variations in adverse events, functional outcomes, and satisfaction scores between groups.
CONCLUSION


Continuous nefopam administration as part of multimodal analgesia for 24 hours post-TKA produced a significant analgesic effect but only within the first 6 hours. However, there was a notable reduction in morphine use 48 hours postop. Nefopam is a useful agent for contemporary pain control after TKA.
LEVEL OF EVIDENCE


Therapeutic Level I.",2022,"Total morphine consumption (0-48 hours) was 37% less, significantly lower, in the nefopam group (5.3±4.5 vs. 8.4±7.5 mg, p=0.03).","['patients undergoing unilateral primary TKA, comparing 24 hours of 80 mg of continuous intravenous nefopam to']","['morphine', 'total knee arthroplasty (TKA', 'placebo infusion']","['Antiemetic consumption', 'motion VAS scores', 'VAS', 'adverse events, functional outcomes, and satisfaction scores', 'analgesic effect', 'Morphine Consumption', 'Total morphine consumption', 'morphine and antiemetic consumption, adverse events, and functional outcomes: time-to-walk, timed up-and-go test, postoperative knee range of motion at 24 and 48 hours, time-to-discharge, and patient satisfaction scores', '100-mm visual analog scale (VAS) for pain-at-rest']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0027556', 'cui_str': 'Nefopam'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}]",,0.696176,"Total morphine consumption (0-48 hours) was 37% less, significantly lower, in the nefopam group (5.3±4.5 vs. 8.4±7.5 mg, p=0.03).","[{'ForeName': 'Piya', 'Initials': 'P', 'LastName': 'Pinsornsak', 'Affiliation': 'Department of Orthopaedic Surgery, Thammasat University, Pathum Thani, Thailand.'}, {'ForeName': 'Sorachat', 'Initials': 'S', 'LastName': 'Sukkarnkosol', 'Affiliation': 'Department of Orthopaedic Surgery, Thammasat University, Pathum Thani, Thailand.'}, {'ForeName': 'Krit', 'Initials': 'K', 'LastName': 'Boontanapibul', 'Affiliation': 'Department of Orthopaedic Surgery, Chulabhorn International College of Medicine Thammasat University, Pathum Thani, Thailand.'}]",The Journal of arthroplasty,['10.1016/j.arth.2022.01.079']
1906,35121566,Reducing social anxiety in adolescents distressed by a visible difference: Results from a randomised control trial of a web-based intervention.,"A visible difference to the face or body may challenge adolescents' adjustment and engagement in life activities, where some require psychosocial support. However, evidence is limited for whether existing interventions for this adolescent group reduce social or appearance-related distress. We therefore conducted a parallel-group, randomised control trial to evaluate the effectiveness of Young Person's Face IT, a self-guided web-based psychosocial intervention developed for adolescents with a visible difference who experience distress. Adolescents (N = 189, aged 11-18) from two countries (Norway and the Netherlands), were randomly allocated to an intervention group or care as usual (CAU). Outcomes were body esteem, social anxiety, perceived stigmatisation, and life disengagement. Compared with CAU, participants who completed Young Person's Face IT showed reductions in social anxiety symptoms (η p 2  = 0.06). No significant improvements were found for the other outcomes. This study endorses web-based psychosocial support in reducing social anxiety in adolescents distressed by a visible difference. Future studies are needed to confirm the effectiveness of Young Person's Face IT and to explore potential long-term effects.",2022,"Compared with CAU, participants who completed Young Person's Face IT showed reductions in social anxiety symptoms (η p 2  = 0.06).","['adolescents distressed by a visible difference', 'Adolescents (N\xa0=\xa0189, aged 11-18) from two countries (Norway and the Netherlands', 'adolescents with a visible difference who experience distress']","['CAU', 'self-guided web-based psychosocial intervention', 'intervention group or care as usual (CAU']","['body esteem, social anxiety, perceived stigmatisation, and life disengagement', 'social anxiety', 'social anxiety symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",189.0,0.0261275,"Compared with CAU, participants who completed Young Person's Face IT showed reductions in social anxiety symptoms (η p 2  = 0.06).","[{'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Zelihić', 'Affiliation': 'Centre for Rare Disorders, Rikshospitalet, Oslo University Hospital, Norway; Department of Psychology, University of Oslo, Norway. Electronic address: denzel@ous-hf.no.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'van Dalen', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC Sophia Children's Hospital, Rotterdam, the Netherlands.""}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Kling', 'Affiliation': 'Centre for Rare Disorders, Rikshospitalet, Oslo University Hospital, Norway.'}, {'ForeName': 'Are Hugo', 'Initials': 'AH', 'LastName': 'Pripp', 'Affiliation': 'Oslo Centre of Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Norway.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Nordgreen', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Ingela L', 'Initials': 'IL', 'LastName': 'Kvalem', 'Affiliation': 'Department of Psychology, University of Oslo, Norway.'}, {'ForeName': 'Suzanne G M A', 'Initials': 'SGMA', 'LastName': 'Pasmans', 'Affiliation': ""Department of Dermatology, Erasmus MC Sophia Children's Hospital, Rotterdam, the Netherlands.""}, {'ForeName': 'Irene M J', 'Initials': 'IMJ', 'LastName': 'Mathijssen', 'Affiliation': ""Department of Plastic and Reconstructive Surgery and Hand Surgery, The Dutch Craniofacial Centre, Erasmus MC Sophia Children's Hospital, Rotterdam, the Netherlands.""}, {'ForeName': 'Maarten J', 'Initials': 'MJ', 'LastName': 'Koudstaal', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, The Dutch Craniofacial Centre, Erasmus MC Sophia Children's Hospital, Rotterdam, the Netherlands.""}, {'ForeName': 'Manon H J', 'Initials': 'MHJ', 'LastName': 'Hillegers', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC Sophia Children's Hospital, Rotterdam, the Netherlands.""}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Williamson', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK.'}, {'ForeName': 'Elisabeth M W J', 'Initials': 'EMWJ', 'LastName': 'Utens', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC Sophia Children's Hospital, Rotterdam, the Netherlands; Research Institute of Child Development and Education, University of Amsterdam, the Netherlands; Academic Center for Child Psychiatry Levvel/Department of Child and Adolescent Psychiatry, Academic University Medical Center, the Netherlands.""}, {'ForeName': 'Kristin B', 'Initials': 'KB', 'LastName': 'Feragen', 'Affiliation': 'Centre for Rare Disorders, Rikshospitalet, Oslo University Hospital, Norway.'}, {'ForeName': 'Jolanda M E', 'Initials': 'JME', 'LastName': 'Okkerse', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC Sophia Children's Hospital, Rotterdam, the Netherlands.""}]",Body image,['10.1016/j.bodyim.2022.01.008']
1907,35121397,Clinical trial outcomes in oral squamous cell carcinoma: A pragmatic ideation.,,2022,,['oral squamous cell carcinoma'],[],[],"[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]",[],[],,0.305982,,"[{'ForeName': 'Monal', 'Initials': 'M', 'LastName': 'Yuwanati', 'Affiliation': 'Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai 600077, India. Electronic address: monal9817@gmail.com.'}, {'ForeName': 'Sachin C', 'Initials': 'SC', 'LastName': 'Sarode', 'Affiliation': 'Dr. D.Y. Patil Dental College & Hospital, Dr. D.Y. Patil Vidyapeeth, Pune, Maharashtra State, India.'}, {'ForeName': 'Gargi S', 'Initials': 'GS', 'LastName': 'Sarode', 'Affiliation': 'Dr. D.Y. Patil Dental College & Hospital, Dr. D.Y. Patil Vidyapeeth, Pune, Maharashtra State, India.'}, {'ForeName': 'Amol', 'Initials': 'A', 'LastName': 'Gadbail', 'Affiliation': 'Indira Gandhi Government Medical College & Hospital, Nagpur, Maharashtra State, India.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Gondivkar', 'Affiliation': 'Government Dental College & Hospital, Nagpur, Maharashtra State, India.'}]",Oral oncology,['10.1016/j.oraloncology.2022.105752']
1908,35121396,Refining TNM-8 M1 categories with anatomic subgroups for previously untreated de novo metastatic nasopharyngeal carcinoma.,"PURPOSE


To propose a refined M1 classification in de novo metastatic nasopharyngeal carcinoma (NPC) based on pooled data from two academic institutions.
METHODS


Previously untreated de novo M1 NPC patients prospectively treated at The University of Hong Kong (N = 69) and Fujian Cancer Hospital (N = 114) between 2007 and 2016 were recruited and randomized in a 2:1 ratio to generate training (N = 120) and validation (N = 63) cohorts, respectively. Multivariable analysis (MVA) was performed for the training and validation cohorts to identify anatomic prognostic factors for overall survival (OS). Recursive partitioning analysis (RPA) was performed which incorporated the anatomic prognostic factors identified in the MVA to derive Anatomic-RPA groups which stratified OS in the training cohort, and were then validated in the validation cohort.
RESULTS


Median follow-up for the training and validation cohorts was 27.2 and 30.2 months with 3-year OS of 51.6% and 51.1%, respectively. MVA revealed that co-existing liver-bone metastases was the only factor prognostic for OS in both the training and validation cohorts. Anatomic-RPA separated M1 disease into M1a (no co-existing liver-bone metastases) and M1b (co-existing liver-bone metastases) with median OS 39.5 and 23.7 months, respectively (p = 0.004) in the training cohort. RPA for the validation cohort also confirmed good segregation with co-existing liver-bone metastases with median OS 47.7 and 16.0 months, respectively (p = 0.008).
CONCLUSION


Our proposal to subdivide de novo M1 NPC into M1a (no co-existing liver-bone metastases) vs. M1b (co-existing liver-bone metastases) provides better OS segregation.",2022,MVA revealed that co-existing liver-bone metastases was the only factor prognostic for OS in both the training and validation cohorts.,"['Previously untreated de novo M1 NPC patients prospectively treated at The University of Hong Kong', 'N\xa0=\xa069) and Fujian Cancer Hospital (N\xa0=\xa0114) between 2007 and 2016']",[],[],"[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C4708785', 'cui_str': '114'}]",[],[],114.0,0.0349503,MVA revealed that co-existing liver-bone metastases was the only factor prognostic for OS in both the training and validation cohorts.,"[{'ForeName': 'Sik Kwan', 'Initials': 'SK', 'LastName': 'Chan', 'Affiliation': 'Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Fuzhou, China; Fujian Provincial Key Laboratory of Translational Cancer Medicine, Fuzhou, China.'}, {'ForeName': 'Shao Hui', 'Initials': 'SH', 'LastName': 'Huang', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada; Clinical Oncology Center, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Tin Ching', 'Initials': 'TC', 'LastName': 'Chau', 'Affiliation': 'Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Qiao Juan', 'Initials': 'QJ', 'LastName': 'Guo', 'Affiliation': 'Department of Radiation Oncology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Fuzhou, China; Fujian Provincial Key Laboratory of Translational Cancer Medicine, Fuzhou, China.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': ""O'Sullivan"", 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada; Clinical Oncology Center, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Ka On', 'Initials': 'KO', 'LastName': 'Lam', 'Affiliation': 'Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong; Clinical Oncology Center, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Sze Chun', 'Initials': 'SC', 'LastName': 'Chau', 'Affiliation': 'Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Sum Yin', 'Initials': 'SY', 'LastName': 'Chan', 'Affiliation': 'Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Chi Chung', 'Initials': 'CC', 'LastName': 'Tong', 'Affiliation': 'Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Varut', 'Initials': 'V', 'LastName': 'Vardhanabhuti', 'Affiliation': 'Department of Diagnostic Radiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Dora Lai Wan', 'Initials': 'DLW', 'LastName': 'Kwong', 'Affiliation': 'Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong; Clinical Oncology Center, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Tsz Him', 'Initials': 'TH', 'LastName': 'So', 'Affiliation': 'Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Chor Yi', 'Initials': 'CY', 'LastName': 'Ng', 'Affiliation': 'Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'To Wai', 'Initials': 'TW', 'LastName': 'Leung', 'Affiliation': 'Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong; Clinical Oncology Center, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Mai Yee', 'Initials': 'MY', 'LastName': 'Luk', 'Affiliation': 'Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Anne Wing Mui', 'Initials': 'AWM', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong; Clinical Oncology Center, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Horace Cheuk Wai', 'Initials': 'HCW', 'LastName': 'Choi', 'Affiliation': 'Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Jian Ji', 'Initials': 'JJ', 'LastName': 'Pan', 'Affiliation': 'Department of Radiation Oncology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Fuzhou, China; Fujian Provincial Key Laboratory of Translational Cancer Medicine, Fuzhou, China. Electronic address: panjianji1956@fjmu.edu.cn.'}, {'ForeName': 'Victor Ho Fun', 'Initials': 'VHF', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong; Clinical Oncology Center, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China. Electronic address: vhflee@hku.hk.'}]",Oral oncology,['10.1016/j.oraloncology.2022.105736']
1909,35122877,Duration of an acute moderate-intensity exercise session affects approach bias toward high-calorie food among individuals with obesity.,"Obesity is partly driven by unhealthy eating behaviors underpinned by an approach bias toward high-calorie food. Although exercise is a useful strategy for weight loss among individuals with obesity, whether exercise modulates this approach bias is unclear. This study assessed whether the duration of an acute moderate-intensity exercise altered the approach bias toward high-calorie food among individuals with obesity. In total, 24 individuals with obesity were included in this study with a randomized, counterbalanced, crossover design. Participants completed three sessions of 30, 45, or 60 min of moderate-intensity exercise (40%-59% of heart rate reserve) on an elliptical trainer or completed a control rest session for 55 min. Food approach bias was evaluated using a joystick-based approach-avoidance task immediately before and after each session. Two-way repeated-measures analysis of variance was used to analyze the data. We found that compared with that before exercise, the approach bias score toward high-calorie food was significantly decreased only in the 45-min exercise session (p = .015) and that this score was also significantly lower than that after both the 60-min exercise session (p = .002) and the control session (p = .024). These findings suggest a dose-response relationship between exercise duration and approach bias, with 45 min of moderate-intensity exercise being an effective strategy for decreasing the approach bias toward high-calorie food among individuals with obesity.",2022,"We found that compared with that before exercise, the approach bias score toward high-calorie food was significantly decreased only in the 45-minute exercise session (p = .015) and that this score was also significantly lower than that after both the 60-minute exercise session (p = .002) and the control session (p = .024).","['24 individuals with obesity', 'individuals with obesity']","['intensity exercise session', 'moderate-intensity exercise (40%-59% of heart rate reserve) on an elliptical trainer or completed a control rest session']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",[],24.0,0.0117745,"We found that compared with that before exercise, the approach bias score toward high-calorie food was significantly decreased only in the 45-minute exercise session (p = .015) and that this score was also significantly lower than that after both the 60-minute exercise session (p = .002) and the control session (p = .024).","[{'ForeName': 'Yansong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Xia', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Anqi', 'Initials': 'A', 'LastName': 'Yu', 'Affiliation': 'Shanghai Dianfeng Institute of Fat Lose, Shanghai, China.'}, {'ForeName': 'Huangmei', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Chunhua', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China. Electronic address: zch20080808@126.com.'}]",Appetite,['10.1016/j.appet.2022.105955']
1910,35123105,Effects of labour analgesia with different concentrations of ropivacaine on maternal body temperature and inflammatory factor: A randomised controlled study.,"PURPOSE


To investigate the effect of different concentrations of ropivacaine on maternal temperature and inflammatory factors during epidural analgesia.
METHOD


One hundred and forty healthy term nulliparas were randomly assigned to receive epidural analgesia with either 0.1% ropivacaine (group H) or 0.068% ropivacaine (group L). Epidural sufentanil 0.3 μg/mL was added in both groups. Maternal tympanic temperature was measured at initiation of epidural analgesia (baseline temperature) and each hour thereafter. Maternal blood samples were taken at the time of epidural placement and 4 hours after analgesia to detect IL-6 and IL-1β serum concentrations. Visual analog scale pain scores, labour events and neonatal outcomes were recorded.
RESULTS


Epidural analgesia using 0.1% or 0.068% ropivacaine both achieved satisfactory pain relief. Increases in maternal body temperature and in IL-6 levels were observed in both groups, but there was no significant difference between the two groups. The incidence of maternal fever was similar between the two groups.
CONCLUSION


Maternal body temperature and serum inflammatory factors are similarly affected by 0.1% or 0.068% ropivacaine used during epidural analgesia use for labour pain relief.",2022,"Increases in maternal body temperature and in IL-6 levels were observed in both groups, but there was no significant difference between the two groups.",['One hundred and forty healthy term nulliparas'],"['ropivacaine', 'labour analgesia', 'epidural analgesia with either 0.1% ropivacaine', 'Epidural sufentanil', 'IL-6']","['Visual analog scale pain scores, labour events and neonatal outcomes', 'incidence of maternal fever', 'maternal body temperature and inflammatory factor', 'Maternal tympanic temperature', 'Maternal body temperature and serum inflammatory factors', 'labour pain relief', 'and IL-1β serum concentrations', 'maternal body temperature and in IL-6 levels', 'Maternal blood samples', 'maternal temperature and inflammatory factors', 'satisfactory pain relief']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C1532039', 'cui_str': 'Tympanic temperature'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",140.0,0.030301,"Increases in maternal body temperature and in IL-6 levels were observed in both groups, but there was no significant difference between the two groups.","[{'ForeName': 'Xiubin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Anaesthesiology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai 201204, China.'}, {'ForeName': 'Yueqi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anaesthesiology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai 201204, China.'}, {'ForeName': 'Xiu', 'Initials': 'X', 'LastName': 'Ni', 'Affiliation': 'Department of Anaesthesiology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai 201204, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Anaesthesiology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai 201204, China. Electronic address: drliuzhiqiang@163.com.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2022.101030']
1911,35123014,Effect of photodynamic therapy on resin-dentin bonding interface using different illumination times.,"OBJECTIVES


The aim of the present study was to evaluate the effect of photodynamic therapy(PDT) on the resin-dentin bonding interface using different illumination time.
METHODS


Seventy completed, isolated molar teeth were collected for this study, sixty of them were used in microtensile bond strength tests. These teeth were initially divided randomly in two main groups(n= 30) by the random number table method upon the type of using illumination or not, respectively. Then these groups followed by dividing each category in five subgroups(n = 6): group A, group B1,group B2, group B3, group B4, group a, group b1, group b2, group b3, group b4. After different treatment, the remaining teeth were made specimens which were observed the fracture modes and interfaces under a stereomicroscope and a scanning electron microscope(SEM). The dentin permeability of the specimens were evaluated by a confocal laser scanning microscopy(CLSM). To detect significance difference between means of different groups analysis of variance(ANOVA) was performed followed by LSD-t tests.
RESULTS


There was a significant statistical difference in the microtensile bond strength of the different illumination time of PDT between four experimental groups and the control (P < 0.05).
CONCLUSION


With the increase of the illumination time in PDT, the bonding strength between resin and dentin decreased gradually.",2022,"There was a significant statistical difference in the microtensile bond strength of the different illumination time of PDT between four experimental groups and the control (P<0.05).
","['Seventy completed, isolated molar teeth were collected for this study, sixty of them were used in microtensile bond strength tests']","['photodynamic therapy(PDT', 'photodynamic therapy']","['microtensile bond strength of the different illumination time of PDT', 'dentin permeability']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0011431', 'cui_str': 'Dentin Permeability'}]",70.0,0.0119355,"There was a significant statistical difference in the microtensile bond strength of the different illumination time of PDT between four experimental groups and the control (P<0.05).
","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Stomotology, First Hospital Affiliated to Zhengzhou University, Zhengzhou University, Zhengzhou 450052,China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Stomotology, First Hospital Affiliated to Zhengzhou University, Zhengzhou University, Zhengzhou 450052,China. Electronic address: guojiajia1231120@163.com.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Stomotology, First Hospital Affiliated to Zhengzhou University, Zhengzhou University, Zhengzhou 450052,China.'}, {'ForeName': 'Mengjie', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'Department of Stomotology, First Hospital Affiliated to Zhengzhou University, Zhengzhou University, Zhengzhou 450052,China.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2022.102747']
1912,35123210,"Effects of circulating estradiol on physiological, behavioural, and subjective correlates of anxiety: A double-blind, randomized, placebo-controlled trial.","Anxiety-related behaviours as well as the prevalence of anxiety disorders show a large sex difference in humans. Clinical studies in humans as well as behavioural studies in rodents suggest that estradiol may have anxiolytic properties. In line with this, anxiety symptoms fluctuate with estradiol levels along the menstrual cycle. However, the influence of estradiol on subjective, behavioural, as well as physiological correlates of anxiety has never been systematically addressed in humans. We ran a double-blind, randomized, placebo-controlled study (N = 126) to investigate the effects of estradiol on anxiety in men and women. In healthy volunteers, circulating estradiol levels were elevated through estradiol administration over two consecutive days to simulate the rise in estradiol levels around ovulation. Subjective, behavioral, as well as, physiological correlates of anxiety were assessed using a virtual reality elevated plus-maze (EPM). Estradiol treatment reduced the physiological stress response with blunted heart rate response and lower cortisol levels compared to placebo treatment in both sexes. In contrast, respiration frequency was only reduced in women after estradiol treatment. Behavioural measures of anxiety as well as subjective anxiety on the EPM were not affected by estradiol treatment. In general, women showed more avoidance and less approach behavior and reported higher subjective anxiety levels on the EPM than men. These results highlight the limited anxiolytic properties of circulating levels of estradiol in humans, which influence physiological markers of anxiety but not approach and avoidance behaviour or subjective anxiety levels.",2022,Estradiol treatment reduced the physiological stress response with blunted heart rate response and lower cortisol levels compared to placebo treatment in both sexes.,"['men and women', 'healthy volunteers']","['placebo', 'estradiol', 'Estradiol', 'circulating estradiol']","['physiological, behavioural, and subjective correlates of anxiety', 'circulating estradiol levels', 'subjective anxiety on the EPM', 'Behavioural measures of anxiety', 'respiration frequency', 'physiological stress response', 'Subjective, behavioral, as well as, physiological correlates of anxiety', 'subjective anxiety levels', 'cortisol levels']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0083355', 'cui_str': 'MAZE protocol'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2350025', 'cui_str': 'Physiological Stress Reaction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",,0.0435839,Estradiol treatment reduced the physiological stress response with blunted heart rate response and lower cortisol levels compared to placebo treatment in both sexes.,"[{'ForeName': 'Sawis', 'Initials': 'S', 'LastName': 'Nouri', 'Affiliation': 'Institute of Forensic Psychiatry and Sex Research, University of Duisburg-Essen, Virchowstraße 174, 45147 Essen, Germany; Human Behavior Laboratory, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, Center of Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Sarah V', 'Initials': 'SV', 'LastName': 'Biedermann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Center of Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Joue', 'Affiliation': 'Institute of Systems Neuroscience, Center of Experimental Medicine, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Matthias K', 'Initials': 'MK', 'LastName': 'Auer', 'Affiliation': 'Medizinische Klinik and Poliklinik IV, Klinikum der Universität München, LMU München, 80539 Munich, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Sommer', 'Affiliation': 'Institute of Systems Neuroscience, Center of Experimental Medicine, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Fuss', 'Affiliation': 'Institute of Forensic Psychiatry and Sex Research, University of Duisburg-Essen, Virchowstraße 174, 45147 Essen, Germany; Human Behavior Laboratory, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, Center of Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: johannes.fuss@uni-due.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2022.105682']
1913,35123203,Eight-week multi-domain cognitive training does not impact large-scale resting-state brain networks in Parkinson's disease.,"There is meta-analytic evidence for the efficacy of cognitive training (CT) in Parkinson's disease (PD). We performed a randomized controlled trial where we found small positive effects of CT on executive function and processing speed in individuals with PD (n total  = 140). In this study, we assessed the effects of CT on brain network connectivity and topology in a subsample of the full study population (n mri  = 86). Participants were randomized into an online multi-domain CT and an active control condition and performed 24 sessions of either intervention in eight weeks. Resting-state functional MRI scans were acquired in addition to extensive clinical and neuropsychological assessments pre- and post-intervention. In line with our preregistered analysis plan (osf.io/3st82), we computed connectivity between 'cognitive' resting-state networks and computed topological outcomes at the whole-brain and sub-network level. We assessed group differences after the intervention with mixed-model analyses adjusting for baseline performance and analyzed the association between network and cognitive performance changes with repeated measures correlation analyses. The final analysis sample consisted of 71 participants (n CT = 37). After intervention there were no group differences on between-network connectivity and network topological outcomes. No associations between neural network and neuropsychological performance change were found. CT increased segregated network topology in a small sub-sample of cognitively intact participants. Post-hoc nodal analyses showed post-intervention enhanced connectivity of both the dorsal anterior cingulate cortex and dorsolateral prefrontal cortex in the CT group. The results suggest no large-scale brain network effects of eight-week computerized CT, but rather localized connectivity changes of key regions in cognitive function, that potentially reflect the specific effects of the intervention.",2022,Post-hoc nodal analyses showed post-intervention enhanced connectivity of both the dorsal anterior cingulate cortex and dorsolateral prefrontal cortex in the CT group.,"['a subsample of the full study population (n mri \xa0=\xa086', ""Parkinson's disease"", ""Parkinson's disease (PD"", 'individuals with PD (n total \xa0=\xa0140']","['CT', 'cognitive training (CT', 'online multi-domain CT and an active control condition']","['dorsal anterior cingulate cortex and dorsolateral prefrontal cortex', 'executive function and processing speed', 'neural network and neuropsychological performance change', 'network connectivity and network topological outcomes', 'brain network connectivity and topology']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0002812', 'cui_str': 'Regional Anatomy'}]",71.0,0.0725345,Post-hoc nodal analyses showed post-intervention enhanced connectivity of both the dorsal anterior cingulate cortex and dorsolateral prefrontal cortex in the CT group.,"[{'ForeName': 'Tim D', 'Initials': 'TD', 'LastName': 'van Balkom', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands; Amsterdam UMC, Vrije Universiteit Amsterdam, Anatomy and Neurosciences, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands. Electronic address: t.vanbalkom@amsterdamumc.nl.'}, {'ForeName': 'Odile A', 'Initials': 'OA', 'LastName': 'van den Heuvel', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands; Amsterdam UMC, Vrije Universiteit Amsterdam, Anatomy and Neurosciences, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands. Electronic address: oa.vandenheuvel@amsterdamumc.nl.'}, {'ForeName': 'Henk W', 'Initials': 'HW', 'LastName': 'Berendse', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Neurology, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands. Electronic address: h.berendse@amsterdamumc.nl.'}, {'ForeName': 'Ysbrand D', 'Initials': 'YD', 'LastName': 'van der Werf', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Anatomy and Neurosciences, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands. Electronic address: yd.vanderwerf@amsterdamumc.nl.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Vriend', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Psychiatry, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands; Amsterdam UMC, Vrije Universiteit Amsterdam, Anatomy and Neurosciences, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands. Electronic address: c.vriend@amsterdamumc.nl.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2022.102952']
1914,35124234,Safety and efficacy of apixaban thromboprophylaxis in ambulatory cancer patients according to renal function: A subgroup analysis of the AVERT trial.,"BACKGROUND


Apixaban was effective in preventing venous thromboembolism (VTE) in ambulatory cancer patients with Khorana score ≥2 initiating chemotherapy, but with an increased risk of bleeding. Patients with cancer have a higher risk of renal dysfunction, which may be associated with increased risks of thrombotic or bleeding complications. We sought to assess the efficacy and safety of apixaban thromboprophylaxis according to renal function in the AVERT trial.
METHODS


AVERT trial was a randomized, double-blinded, placebo-controlled trial evaluating apixaban as primary thromboprophylaxis for ambulatory cancer patients. The primary efficacy outcome was objectively confirmed VTE within 180 days of randomization. The primary safety outcome was major bleeding events.
RESULTS


Among 574 patients randomized, 66 (11.5%) patients had CrCl <60 mL/min and 508 (88.5%) had CrCl ≥60 mL/min. Patients with CrCl <60 mL/min were older, more likely to be female, had lower weight/body mass index, and poorer ECOG performance status. In patients with CrCl <60 mL/min, there were one VTE and one major bleeding event, with no differences in outcomes between apixaban and placebo. In patients with CrCl ≥60 mL/min, apixaban was associated with a significantly lower rate of VTE and overall mortality compared to placebo without an increased risk of bleeding events. The risk of VTE was significantly higher in patients with CrCl ≥60 mL/min.
CONCLUSIONS


In the AVERT trial, patients with CrCl <60 mL/min did not have higher risk of thrombotic or bleeding complications compared to those with CrCl ≥60 mL/min. (Funded by the CIHR and Bristol-Myers Squibb-Pfizer Alliance; NCT02048865).",2022,"mL/min, apixaban was associated with a significantly lower rate of VTE and overall mortality compared to placebo without an increased risk of bleeding events.","['574 patients randomized, 66 (11.5%) patients had CrCl <60\xa0mL/min and 508 (88.5%) had CrCl ≥60\xa0mL/min', 'ambulatory cancer patients', 'Patients with cancer', 'patients with CrCl ≥60', 'ambulatory cancer patients with Khorana score ≥2 initiating', 'ambulatory cancer patients according to renal function']","['chemotherapy', 'placebo', 'apixaban and placebo', 'apixaban thromboprophylaxis', 'apixaban']","['major bleeding events', 'risk of bleeding events', 'efficacy and safety', 'risk of VTE', 'risk of thrombotic or bleeding complications', 'rate of VTE and overall mortality', 'renal dysfunction', 'lower weight/body mass index, and poorer ECOG performance status', 'risks of thrombotic or bleeding complications', 'Safety and efficacy', 'venous thromboembolism (VTE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}]",574.0,0.42502,"mL/min, apixaban was associated with a significantly lower rate of VTE and overall mortality compared to placebo without an increased risk of bleeding events.","[{'ForeName': 'Tzu-Fei', 'Initials': 'TF', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, University of Ottawa at The Ottawa Hospital and Ottawa Hospital Research Institute, Ottawa, ON, Canada. Electronic address: tzwang@toh.ca.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Department of Medicine, University of Ottawa at The Ottawa Hospital and Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, University of Ottawa at The Ottawa Hospital and Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]",Thrombosis research,['10.1016/j.thromres.2022.01.022']
1915,35125129,Housing First for homeless people with severe mental illness: extended 4-year follow-up and analysis of recovery and housing stability from the randomized  Un Chez Soi d'Abord  trial.,"AIMS


Housing First (HF), a recovery-oriented approach, was proven effective in stabilising housing situations of homeless individuals with severe mental disorders, yet had limited effectiveness on recovery outcomes on a short-term basis compared to standard treatment. The objective was to assess the effects of the HF model among homeless people with high support needs for mental and physical health services on recovery, housing stability, quality of life, health care use, mental symptoms and addiction issues on 4 years of data from the Un Chez Soi d'Abord trial.
METHODS


A multicentre randomised controlled trial was conducted from August 2011 to April 2018 with intent-to-treat analysis in four French cities: Lille, Marseille, Paris and Toulouse. Participants were homeless or precariously-housed patients with a DSM-IV-TR diagnosis of bipolar disorder or schizophrenia. Two groups were compared: the HF group (n = 353) had immediate access to independent housing and support from the assertive community treatment team; the Treatment-As-Usual (TAU) group (n = 350) had access to existing support and services. Main outcomes were personal recovery (Recovery Assessment Scale (RAS) scale), housing stability, quality of life (S-QoL), global physical and mental status (Medical Outcomes Study 36-item Short Form Health Survey (SF-36)), inpatient days, mental symptoms (Modified Colorado Symptom Index (MCSI)) and addictions (Mini International Neuropsychiatric Interview (MINI) and Alcohol Use Disorders Identification Test (AUDIT)). Mixed models using longitudinal and cluster designs were performed and adjusted to first age on the street, gender and mental disorder diagnosis. Models were tested for time × group and site × time interactions.
RESULTS


The 703 participants [123 (18%) female] had a mean age of 39 years (95% CI 38.0-39.5 years). Both groups improved RAS index from baseline to 48 months, with no statistically significant changes found between the HF and TAU groups over time. HF patients exhibited better autonomy (adjusted β = 2.6, 95% CI 1.2-4.1) and sentimental life (2.3, 95% CI 0.5-4.1), higher housing stability (28.6, 95% CI 25.1-32.1), lower inpatient days (-3.14, 95% CI -5.2 to -1.1) and improved SF-36 mental composite score (-0.8, 95% CI -1.6 to -0.1) over the 4-year follow-up. HF participants experienced higher alcohol consumption between baseline and 48 months. No significant differences were observed for self-reported mental symptoms or substance dependence.
CONCLUSION


Data at 4 years were consistent with 2-year follow-up data: similar improvement in personal recovery outcomes but higher housing stability, autonomy and lower use of hospital services in the HF group compared to the TAU group, with the exception of an ongoing alcohol issue. These sustained benefits support HF as a valuable intervention for the homeless patients with severe mental illness.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01570712.",2022,"Both groups improved RAS index from baseline to 48 months, with no statistically significant changes found between the HF and TAU groups over time.","['homeless patients with severe mental illness', 'August 2011 to April 2018 with intent-to-treat analysis in four French cities: Lille, Marseille, Paris and Toulouse', 'homeless individuals with severe mental disorders', '703 participants [123 (18%) female] had a mean age of 39 years (95% CI 38.0-39.5 years', 'homeless people with severe mental illness', 'homeless people with high support needs for mental and physical health services', 'Participants were homeless or precariously-housed patients with a DSM-IV-TR diagnosis of bipolar disorder or schizophrenia']",['immediate access to independent housing and support from the assertive community treatment team; the Treatment-As-Usual (TAU) group (n = 350) had access to existing support and services'],"['SF-36 mental composite score', 'self-reported mental symptoms or substance dependence', 'higher housing stability', 'housing stability, autonomy and lower use of hospital services', 'personal recovery (Recovery Assessment Scale (RAS) scale), housing stability, quality of life (S-QoL), global physical and mental status (Medical Outcomes Study 36-item Short Form Health Survey (SF-36)), inpatient days, mental symptoms (Modified Colorado Symptom Index (MCSI)) and addictions (Mini International Neuropsychiatric Interview (MINI) and Alcohol Use Disorders Identification Test (AUDIT', 'sentimental life', 'alcohol consumption', 'RAS index']","[{'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C0425242', 'cui_str': 'Homeless single person'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2713614', 'cui_str': 'Assertive Community Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0038580', 'cui_str': 'Substance dependence'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",,0.240785,"Both groups improved RAS index from baseline to 48 months, with no statistically significant changes found between the HF and TAU groups over time.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loubière', 'Affiliation': 'School of Medicine - La Timone Medical Campus, Aix-Marseille University, UR 3279: CEReSS - Health Service Research and Quality of Life Center, 13005Marseille, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lemoine', 'Affiliation': 'School of Medicine - La Timone Medical Campus, Aix-Marseille University, UR 3279: CEReSS - Health Service Research and Quality of Life Center, 13005Marseille, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boucekine', 'Affiliation': 'School of Medicine - La Timone Medical Campus, Aix-Marseille University, UR 3279: CEReSS - Health Service Research and Quality of Life Center, 13005Marseille, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Boyer', 'Affiliation': 'School of Medicine - La Timone Medical Campus, Aix-Marseille University, UR 3279: CEReSS - Health Service Research and Quality of Life Center, 13005Marseille, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Girard', 'Affiliation': 'School of Medicine - La Timone Medical Campus, Aix-Marseille University, UR 3279: CEReSS - Health Service Research and Quality of Life Center, 13005Marseille, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tinland', 'Affiliation': 'School of Medicine - La Timone Medical Campus, Aix-Marseille University, UR 3279: CEReSS - Health Service Research and Quality of Life Center, 13005Marseille, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Auquier', 'Affiliation': 'School of Medicine - La Timone Medical Campus, Aix-Marseille University, UR 3279: CEReSS - Health Service Research and Quality of Life Center, 13005Marseille, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Epidemiology and psychiatric sciences,['10.1017/S2045796022000026']
1916,35131497,Monofilament vs multifilament suture for uterine closure at the time of cesarean delivery: a randomized clinical trial.,"BACKGROUND


Different factors may influence the closure of the uterine wall, including suture material. Suture materials may indeed influence tissue healing and therefore the development of scar defects.
OBJECTIVE


To test whether uterine closure using synthetic absorbable monofilament sutures at the time of cesarean delivery would reduce the rate of cesarean scar defects compared with uterine closure using synthetic absorbable multifilament sutures.
STUDY DESIGN


Parallel-group, nonblinded, randomized clinical trial of women with singleton pregnancies undergoing cesarean delivery at term in a single center in Italy. The inclusion criteria were singleton pregnancy, first or second cesarean delivery, scheduled and emergent or urgent cesarean deliveries, and gestational age between 37 0/7 and 42 0/7 weeks. Eligible participants were randomly allocated in a 1:1 ratio to either the monofilament group (polyglytone 6211 [Caprosyn]; Covidien, Dublin, Ireland) or the multifilament suture group (coated polyglactin 910 suture with Triclosan [Vicryl Plus]; Ethicon, Inc, Raritan, NJ). The primary outcome was the incidence of cesarean scar defect at ultrasound at the 6-month follow-up visit. The secondary outcomes were residual myometrial thickness and symptoms.
RESULTS


Overall, 300 women were included in the trial. Of the randomized women, 151 were randomized to the monofilament group and 149 to the multifilament group. However, 27 women were lost to follow-up: 15 in the monofilament group and 12 in the multifilament group. Of note, 6 months after delivery, the incidence rates of cesarean scar defect were 18.4% (25 of 136 patients) in the monofilament group and 23.4% (32 of 137 patients) in the multifilament group (relative risk, 0.79; 95% confidence interval, 0.41-1.25; P=.31). The mean residual myometrial thicknesses were 7.6 mm in the monofilament group and 7.2 mm in the multifilament group (mean difference, +0.40 mm; 95% confidence interval, -0.23 to 1.03). There was no between-group substantial difference found in the incidence of symptoms, including pelvic pain, painful periods, and dyspareunia.
CONCLUSION


In singleton pregnancies undergoing primary or second cesarean delivery, the use of synthetic absorbable monofilament sutures at the time of uterine wall closure was not associated with a reduction in the rate of cesarean scar defect 6 months after delivery compared with the use of synthetic absorbable multifilament sutures.",2022,"No between group significant differences were found in the incidence of symptoms, including pelvic pain, painful periods, and dyspareunia.
","['27 women were lost to follow up, 15 in the monofilament group, and 12 in the multifilament group', 'Inclusion criteria were singleton pregnancy, first or second cesarean delivery, scheduled and emergent or urgent cesarean delivery, gestational age between 37 0/7 and 42 0/7 weeks', '300 women were included in the trial', 'Eligible participants', 'singleton gestations undergoing primary or second cesarean delivery, use of', 'women with singleton pregnancies undergoing cesarean delivery at term in a single center in Italy']","['Monofilament vs multifilament suture', 'synthetic absorbable multifilament sutures', 'monofilament (Polyglytone 6211; Caprosyn, Covidien) or to the multifilament suture group (coated Polyglactin 910 suture with Triclosan; Vicryl Plus, Ethicon', 'synthetic absorbable monofilament sutures']","['residual myometrial thickness (RMT), and symptoms', 'incidence of symptoms, including pelvic pain, painful periods, and dyspareunia', 'rate of cesarean scar defect', 'incidence of cesarean scar defect', 'rate of cesarean scar defects', 'mean RMT']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0558380', 'cui_str': 'Emergency cesarean section'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C1961533', 'cui_str': 'Multifilament suture'}, {'cui': 'C1702173', 'cui_str': 'polyglytone 6211'}, {'cui': 'C1698175', 'cui_str': 'Caprosyn'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0032495', 'cui_str': 'Polygalactin 910'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}, {'cui': 'C0947694', 'cui_str': 'Vicryl'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1961537', 'cui_str': 'Monofilament suture'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1275590', 'cui_str': 'Thickness of myometrium'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",300.0,0.197888,"No between group significant differences were found in the incidence of symptoms, including pelvic pain, painful periods, and dyspareunia.
","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Saccone', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences, and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Saccone and Zizolfi, Ms Gragnano, and Drs Musone, Zullo, and Bifulco). Electronic address: gabriele.saccone.1990@gmail.com.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'De Angelis', 'Affiliation': 'Department of Public Health, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Angelis and Di Spiezio Sardo).'}, {'ForeName': 'Brunella', 'Initials': 'B', 'LastName': 'Zizolfi', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences, and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Saccone and Zizolfi, Ms Gragnano, and Drs Musone, Zullo, and Bifulco).'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Gragnano', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences, and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Saccone and Zizolfi, Ms Gragnano, and Drs Musone, Zullo, and Bifulco).'}, {'ForeName': 'Mariateresa', 'Initials': 'M', 'LastName': 'Musone', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences, and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Saccone and Zizolfi, Ms Gragnano, and Drs Musone, Zullo, and Bifulco).'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Zullo', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences, and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Saccone and Zizolfi, Ms Gragnano, and Drs Musone, Zullo, and Bifulco).'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Bifulco', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences, and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Saccone and Zizolfi, Ms Gragnano, and Drs Musone, Zullo, and Bifulco).'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'Di Spiezio Sardo', 'Affiliation': 'Department of Public Health, School of Medicine, University of Naples Federico II, Naples, Italy (Drs Angelis and Di Spiezio Sardo).'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100592']
1917,35133671,Randomized placebo-controlled trial of losartan for pediatric NAFLD.,"BACKGROUND AND AIMS


To date, no pharmacotherapy exists for pediatric NAFLD. Losartan, an angiotensin II receptor blocker, has been proposed as a treatment due to its antifibrotic effects.
APPROACH AND RESULTS


The Nonalcoholic Steatohepatitis Clinical Research Network conducted a multicenter, double-masked, placebo-controlled, randomized clinical trial in children with histologically confirmed NAFLD at 10 sites (September 2018 to April 2020). Inclusion criteria were age 8-17 years, histologic NAFLD activity score ≥ 3, and serum alanine aminotransferase (ALT) ≥ 50 U/l. Children received 100 mg of losartan or placebo orally once daily for 24 weeks. The primary outcome was change in ALT levels from baseline to 24 weeks, and the preset sample size was n = 110. Treatment effects were assessed using linear regression of change in treatment group adjusted for baseline value. Eighty-three participants (81% male, 80% Hispanic) were randomized to losartan (n = 43) or placebo (n = 40). During an enrollment pause, necessitated by the 2019 coronavirus pandemic, an unplanned interim analysis showed low probability (7%) of significant group difference. The Data and Safety Monitoring Board recommended early study termination. Baseline characteristics were similar between groups. The 24-week change in ALT did not differ significantly between losartan versus placebo groups (adjusted mean difference: 1.1 U/l; 95% CI = -30.6, 32.7; p = 0.95), although alkaline phosphatase decreased significantly in the losartan group (adjusted mean difference: -23.4 U/l; 95% CI = -41.5, -5.3; p = 0.01). Systolic blood pressure decreased in the losartan group but increased in placebo (adjusted mean difference: -7.5 mm Hg; 95% CI = -12.2, -2.8; p = 0.002). Compliance by pill counts and numbers and types of adverse events did not differ by group.
CONCLUSIONS


Losartan did not significantly reduce ALT in children with NAFLD when compared with placebo.",2022,"Systolic blood pressure decreased in the losartan group but increased in placebo (adjusted mean difference: -7.5 mmHg; 95% CI=-12.2, -2.8; p=0.002).","['children with histologically-confirmed NAFLD at 10 sites (September 2018- April 2020', 'pediatric nonalcoholic fatty liver disease (NAFLD', 'Inclusion criteria were age 8-17 years, histologic NAFLD activity score ≥3, and serum alanine aminotransferase (ALT) ≥50', 'Pediatric Nonalcoholic Fatty Liver Disease', '83 participants (81% male, 80% Hispanic']","['placebo', 'angiotensin II receptor blocker', 'Placebo', 'losartan vs. placebo', 'losartan', 'Losartan', 'losartan or placebo']","['alkaline phosphatase', 'Systolic blood pressure', 'change in ALT levels', 'ALT', 'Compliance by pill counts and numbers and types of adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.691646,"Systolic blood pressure decreased in the losartan group but increased in placebo (adjusted mean difference: -7.5 mmHg; 95% CI=-12.2, -2.8; p=0.002).","[{'ForeName': 'Miriam B', 'Initials': 'MB', 'LastName': 'Vos', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, Georgia, USA.""}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Van Natta', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Niviann M', 'Initials': 'NM', 'LastName': 'Blondet', 'Affiliation': ""Division of Pediatric Gastroenterology and Hepatology, Seattle Children's Hospital, University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Dasarathy', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fishbein', 'Affiliation': 'Department of Pediatrics, Feinberg Medical School of Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Hertel', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Jain', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, St. Louis University, St. Louis, Missouri, USA.'}, {'ForeName': 'Saul J', 'Initials': 'SJ', 'LastName': 'Karpen', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, Georgia, USA.""}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Lavine', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Mohammad', 'Affiliation': 'Department of Pediatrics, Feinberg Medical School of Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Miriel', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Jean P', 'Initials': 'JP', 'LastName': 'Molleston', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Indiana University School of Medicine/Riley Hospital for Children, Indianapolis, Indiana, USA.'}, {'ForeName': 'Marialena', 'Initials': 'M', 'LastName': 'Mouzaki', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.""}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sanyal', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.'}, {'ForeName': 'Emily P', 'Initials': 'EP', 'LastName': 'Sharkey', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Schwimmer', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Wilson', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Stavra A', 'Initials': 'SA', 'LastName': 'Xanthakos', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hepatology (Baltimore, Md.)",['10.1002/hep.32403']
1918,35134323,Guselkumab for the Treatment of Crohn's Disease: Induction Results From the Phase 2 GALAXI-1 Study.,"BACKGROUND & AIMS


Guselkumab, a selective p19 interleukin-23 antagonist, is approved for the treatment of plaque psoriasis and psoriatic arthritis. This study evaluated the efficacy and safety of guselkumab in patients with moderately to severely active Crohn's disease with inadequate response or intolerance to conventional or biologic therapy.
METHODS


GALAXI-1, a phase 2, double-blind, placebo-controlled study, randomized patients 1:1:1:1:1 to intravenous guselkumab 200 mg, 600 mg, or 1200 mg at weeks 0, 4, and 8; intravenous ustekinumab approximately 6 mg/kg at week 0 and 90 mg subcutaneously at week 8; or placebo. Change from baseline in Crohn's Disease Activity Index score (primary end point), clinical remission, and response, Patient Reported Outcomes-2 remission, clinical-biomarker response, endoscopic response (major secondary end points), and safety in guselkumab-treated patients vs placebo were evaluated through week 12. Ustekinumab was a reference arm.
RESULTS


Of 309 patients evaluated, approximately 50% had disease refractory to prior biologic therapy. At week 12, significantly greater reductions in Crohn's Disease Activity Index from baseline (least squares means: 200 mg: -160.4, 600 mg: -138.9, and 1200 mg: -144.9 vs placebo: -36.2; all, P < .05) and significantly greater proportions of patients achieved clinical remission in each guselkumab group vs placebo (Crohn's Disease Activity Index <150; 57.4%, 55.6%, and 45.9% vs 16.4%; all, P < .05). Greater proportions of patients receiving guselkumab achieved clinical response, Patient Reported Outcomes-2 remission, clinical-biomarker response, and endoscopic response at week 12 vs placebo. Efficacy of ustekinumab vs placebo was also demonstrated. Safety event rates were generally similar across treatment groups.
CONCLUSIONS


At week 12, all 3 dose regimens of guselkumab induced greater clinical and endoscopic improvements vs placebo, with a favorable safety profile. ClinicalTrials.gov, Number: NCT03466411.",2022,"At week 12, all three dose regimens of guselkumab induced greater clinical and endoscopic improvements vs placebo, with a favorable safety profile;ClinicalTrials.gov number, NCT03466411.","['309 patients evaluated, approximately 50% had disease refractory to prior biologic therapy', ""patients with moderately to severely active Crohn's disease with inadequate response or intolerance to conventional or biologic therapy"", ""Crohn's disease""]","['Guselkumab', 'placebo', 'intravenous guselkumab', 'ustekinumab vs placebo', 'guselkumab', 'intravenous ustekinumab ∼6 mg/kg at week 0 and 90 mg subcutaneously at week 8; or placebo']","['Safety event rates', ""Crohn's Disease Activity Index (CDAI) score (primary endpoint), clinical remission and response, Patient Reported Outcomes-2 (PRO-2) remission, clinical-biomarker response, endoscopic response"", 'clinical remission', 'clinical response, PRO-2 remission, clinical-biomarker response, and endoscopic response', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0005527', 'cui_str': 'Biotherapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.210471,"At week 12, all three dose regimens of guselkumab induced greater clinical and endoscopic improvements vs placebo, with a favorable safety profile;ClinicalTrials.gov number, NCT03466411.","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California-San Diego, La Jolla, California. Electronic address: wsandborn@health.ucsd.edu.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Reinisch', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Panés', 'Affiliation': 'Hospital Clinic of Barcelona, August Pi i Sunyer Biomedical Research Institute, Biomedical Research Centers on Hepatic and Digestive Diseases, Barcelona, Spain.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Gonzalez', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Germinaro', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Frustaci', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Zijiang', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Omoniyi J', 'Initials': 'OJ', 'LastName': 'Adedokun', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Janssen Global Services, LLC, Malvern, Pennsylvania.'}, {'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Tadakazu', 'Initials': 'T', 'LastName': 'Hisamatsu', 'Affiliation': 'Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Gastroenterology and Endoscopy, Scientific Institute for Research, Hospitalization and Healthcare, Ospedale San Raffaele, University Vita-Salute San Raffaele, Milan, Italy.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Rubin', 'Affiliation': 'The University of Chicago School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Afzali', 'Affiliation': 'The Ohio State University, Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Andrews', 'Affiliation': 'Royal Adelaide Hospital and University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2022.01.047']
1919,35134703,Internet-based treatment for depressive symptoms in hemodialysis patients: A cluster randomized controlled trial.,"OBJECTIVE


To investigate the effectiveness of a guided internet-based self-help intervention for hemodialysis patients with depressive symptoms.
METHOD


Chronic hemodialysis patients from nine Dutch hospitals with a depression score on the Beck Depression Inventory - second edition (BDI-II) of ≥10, were cluster-randomized into a five modules guided internet-based self-help problem solving therapy intervention or a parallel care-as-usual control group. Clusters were based on hemodialysis shift. The primary outcome depression was measured with the BDI-II. Analysis was performed with linear mixed models.
RESULTS


A total of 190 hemodialysis patients were cluster-randomized to the intervention (n = 89) or control group (n = 101). Post-intervention measurement was completed by 127 patients (67%) and more than half of the patients (54%) completed the intervention. No significant differences were found on the BDI-II score between the groups (mean difference - 0.1, 95%CI -3.0; 2.7, p = 0.94). Per protocol sensitivity analysis showed comparable results. No significant differences in secondary outcomes were observed between groups.
CONCLUSIONS


Guided internet-based self-help problem solving therapy for hemodialysis patients with depressive symptoms does not seem to be effective in reducing these symptoms as compared to usual care. Future research should examine how to best design content and accessibility of an intervention for depressive symptoms in hemodialysis patients.
TRIAL REGISTRATION


Dutch Trial Register: Trial NL6648 (NTR6834) (prospectively registered 13th November 2017).",2022,"CONCLUSIONS


Guided internet-based self-help problem solving therapy for hemodialysis patients with depressive symptoms does not seem to be effective in reducing these symptoms as compared to usual care.","['Chronic hemodialysis patients from nine Dutch hospitals with a depression score on the Beck Depression Inventory - second edition (BDI-II) of ≥10, were cluster-randomized into a', '190 hemodialysis patients', 'hemodialysis patients with depressive symptoms', 'hemodialysis patients']","['Guided internet-based self-help problem solving therapy', 'five modules guided internet-based self-help problem solving therapy intervention or a parallel care-as-usual control group', 'guided internet-based self-help intervention', 'Internet-based treatment']","['BDI-II', 'BDI-II score']","[{'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",190.0,0.119589,"CONCLUSIONS


Guided internet-based self-help problem solving therapy for hemodialysis patients with depressive symptoms does not seem to be effective in reducing these symptoms as compared to usual care.","[{'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Nadort', 'Affiliation': 'Department of Psychiatry, OLVG Hospital, Jan Tooropstraat 164, 1061 AE Amsterdam, the Netherlands; Department of Psychiatry, Amsterdam University Medical Centre and GGZ inGeest, Oldenaller 1, 1081, HJ, Amsterdam, the Netherlands. Electronic address: e.nadort@olvg.nl.'}, {'ForeName': 'Robbert W', 'Initials': 'RW', 'LastName': 'Schouten', 'Affiliation': 'Department of Nephrology, OLVG hospital, Jan Tooropstraat 164, 1061 AE Amsterdam, the Netherlands. Electronic address: r.schouten@olvg.nl.'}, {'ForeName': 'Rosa E', 'Initials': 'RE', 'LastName': 'Boeschoten', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centre and GGZ inGeest, Oldenaller 1, 1081, HJ, Amsterdam, the Netherlands. Electronic address: r.boeschoten@ggzingeest.nl.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Smets', 'Affiliation': 'Department of Nephrology, OLVG hospital, Jan Tooropstraat 164, 1061 AE Amsterdam, the Netherlands. Electronic address: Y.F.C.Smets@olvg.nl.'}, {'ForeName': 'Prataap', 'Initials': 'P', 'LastName': 'Chandie Shaw', 'Affiliation': 'Department of Nephrology, Haaglanden Medisch Centrum, Lijnbaan 32, 2512 VA, The Hague, the Netherlands. Electronic address: p.chandieshaw@haaglandenmc.nl.'}, {'ForeName': 'Louis Jean', 'Initials': 'LJ', 'LastName': 'Vleming', 'Affiliation': 'Department of Nephrology, HagaZiekenhuis, Els Borst-Eilersplein 275, 2545 AA The Hague, the Netherlands. Electronic address: l.vleming@hagaziekenhuis.nl.'}, {'ForeName': 'Marijke J E', 'Initials': 'MJE', 'LastName': 'Dekker', 'Affiliation': 'Department of Nephrology, Maasstad Ziekenhuis, Maasstadweg 21, 3079 DZ, Rotterdam, the Netherlands. Electronic address: DekkerM2@maasstadziekenhuis.nl.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Westerman', 'Affiliation': 'Department of Nephrology, Franciscus Gasthuis & Vlietland Ziekenhuis, Kleiweg 500, 3045 PM Rotterdam, the Netherlands. Electronic address: M.Westerman@Franciscus.nl.'}, {'ForeName': 'Ellen K', 'Initials': 'EK', 'LastName': 'Hoogeveen', 'Affiliation': 'Department of Nephrology, Jeroen Bosch Ziekenhuis, Henri Dunantstraat 1, 5223 GZ s-Hertogenbosch, the Netherlands; Department of Clinical Epidemiology, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA Leiden, the Netherlands. Electronic address: E.Hoogeveen@jbz.nl.'}, {'ForeName': 'Willem J W', 'Initials': 'WJW', 'LastName': 'Bos', 'Affiliation': 'Department of Internal Medicine, St. Antonius Ziekenhuis, Koekoekslaan 1, 3435 CM Nieuwegein, the Netherlands; Department of Internal Medicine, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA Leiden, the Netherlands. Electronic address: w.bos@antoniusziekenhuis.nl.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Schouten', 'Affiliation': 'Department of Nephrology, Tergooi Hospital, Van Riebeeckweg 212, 1213 XZ Hilversum, the Netherlands. Electronic address: maschouten@tergooi.nl.'}, {'ForeName': 'Karima', 'Initials': 'K', 'LastName': 'Farhat', 'Affiliation': 'Department of Nephrology, Spaarne Gasthuis, Boerhaavelaan 22, 2035 RC Haarlem, the Netherlands. Electronic address: KFarhat@spaarnegasthuis.nl.'}, {'ForeName': 'Friedo W', 'Initials': 'FW', 'LastName': 'Dekker', 'Affiliation': 'Department of Clinical Epidemiology, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA Leiden, the Netherlands. Electronic address: f.w.dekker@lumc.nl.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'van Oppen', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centre and GGZ inGeest, Oldenaller 1, 1081, HJ, Amsterdam, the Netherlands. Electronic address: p.vanoppen@ggzingeest.nl.'}, {'ForeName': 'Birit F P', 'Initials': 'BFP', 'LastName': 'Broekman', 'Affiliation': 'Department of Psychiatry, OLVG Hospital, Jan Tooropstraat 164, 1061 AE Amsterdam, the Netherlands; Department of Psychiatry, Amsterdam University Medical Centre and GGZ inGeest, Oldenaller 1, 1081, HJ, Amsterdam, the Netherlands. Electronic address: B.F.P.Broekman@olvg.nl.'}, {'ForeName': 'Carl E H', 'Initials': 'CEH', 'LastName': 'Siegert', 'Affiliation': 'Department of Nephrology, OLVG hospital, Jan Tooropstraat 164, 1061 AE Amsterdam, the Netherlands. Electronic address: c.siegert@olvg.nl.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2022.01.008']
1920,35121249,Stimulation of the pedunculopontine and cuneiform nuclei for freezing of gait and falls in Parkinson disease: Cross-over single-blinded study and long-term follow-up.,"INTRODUCTION


Deep brain stimulation (DBS) of the mesencephalic locomotor region, composed of the pedunculopontine (PPN) and cuneiform (CuN) nuclei, has been proposed to treat dopa-resistant gait and balance disorders in Parkinson's disease (PD). Here, we report the long-term effects of PPN- or CuN-DBS on these axial disorders.
METHODS


In 6 PD patients operated for mesencephalic locomotor region DBS and prospectively followed for more than 2 years, we assessed the effects of both PPN- and CuN-DBS (On-dopa) in a cross-over single-blind study by using clinical scales and recording gait parameters. Patients were also examined Off-DBS.
RESULTS


More than 2 years after surgery, axial and Tinetti scores were significantly aggravated with both PPN- or CuN-DBS relative to before and one year after surgery. Gait recordings revealed an increased double-stance duration with both PPN- or CuN-DBS, higher swing phase duration with CuN-DBS and step width with PPN-DBS. With PPN- versus CuN-DBS, the step length, velocity and cadence were significantly higher; and the double-stance and turn durations significantly lower. Irrespective the target, we found no significant change in clinical scores Off-DBS compared to On-DBS. The duration of anticipatory postural adjustments as well as step length were lower with versus without PPN-DBS. We found no other significant changes in motor, cognitive or psychiatric scores, except an increased anxiety severity.
CONCLUSION


In this long-term follow-up study with controlled assessments, PPN- or CuN-DBS did not improve dopa-resistant gait and balance disorders with a worsening of these axial motor signs with time, thus indicating no significant clinical effect.",2022,"Gait recordings revealed an increased double-stance duration with both PPN- or CuN-DBS, higher swing phase duration with CuN-DBS and step width with PPN-DBS.",['Parkinson disease'],"['pedunculopontine (PPN) and cuneiform (CuN) nuclei', 'PPN- and CuN-DBS', 'PPN- or CuN-DBS', 'pedunculopontine and cuneiform nuclei']","['anxiety severity', 'duration of anticipatory postural adjustments', 'step length, velocity and cadence', 'clinical scores Off-DBS', 'axial and Tinetti scores', 'double-stance duration', 'dopa-resistant gait and balance disorders', 'motor, cognitive or psychiatric scores']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C1527386', 'cui_str': 'Peripheral line feeding'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013023', 'cui_str': 'Dihydroxyphenylalanine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0575090', 'cui_str': 'Balance disorder'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]",,0.0750527,"Gait recordings revealed an increased double-stance duration with both PPN- or CuN-DBS, higher swing phase duration with CuN-DBS and step width with PPN-DBS.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bourilhon', 'Affiliation': 'Service de Neurophysiologie Clinique, CHU Rouen, Université de Normandie, F-76000, Rouen, France; Institut du Cerveau, INSERM U1127, Pitié-Salpêtrière Hospital, F-75013, Paris, France.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Mullie', 'Affiliation': 'Institut du Cerveau, INSERM U1127, Pitié-Salpêtrière Hospital, F-75013, Paris, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Olivier', 'Affiliation': 'Institut du Cerveau, INSERM U1127, Pitié-Salpêtrière Hospital, F-75013, Paris, France.'}, {'ForeName': 'Saoussen', 'Initials': 'S', 'LastName': 'Cherif', 'Affiliation': 'Institut du Cerveau, INSERM U1127, Pitié-Salpêtrière Hospital, F-75013, Paris, France.'}, {'ForeName': 'Hayat', 'Initials': 'H', 'LastName': 'Belaid', 'Affiliation': 'Service de Neurochirurgie, Pitié-Salpêtrière Hospital, APHP, F-75013, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Grabli', 'Affiliation': 'Institut du Cerveau, INSERM U1127, Pitié-Salpêtrière Hospital, F-75013, Paris, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Czernecki', 'Affiliation': 'Service de Neurochirurgie, Pitié-Salpêtrière Hospital, APHP, F-75013, Paris, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Karachi', 'Affiliation': 'Institut du Cerveau, INSERM U1127, Pitié-Salpêtrière Hospital, F-75013, Paris, France; Service de Neurochirurgie, Pitié-Salpêtrière Hospital, APHP, F-75013, Paris, France.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Welter', 'Affiliation': 'Service de Neurophysiologie Clinique, CHU Rouen, Université de Normandie, F-76000, Rouen, France; Institut du Cerveau, INSERM U1127, Pitié-Salpêtrière Hospital, F-75013, Paris, France. Electronic address: marielaure.welter@icm-institute.org.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2022.01.010']
1921,35121126,Effect of implementation of a 12-dose once-weekly treatment (3HP) in addition to standard regimens to prevent TB on completion rates: Interrupted time series design.,"OBJECTIVES


We aimed to determine if offering a 12-dose once-weekly treatment (3HP) as an additional treatment option would result in an increase in the overall proportion of patients completing TB preventive treatment (TPT) above the baseline rate.
METHODS


We analyzed outcomes in consecutive adults referred to a TB clinic from January 2010 to May 2019. Starting December 2016, 3HP was offered as an alternative to standard clinic regimens which included 9 months of daily isoniazid or 4 months of daily rifampin. The primary outcome was the proportion of patients who completed TPT among all patients who started treatment. Using segmented autoregression analysis, we compared completion at the end of the study with projected completion had the intervention not been introduced.
RESULTS


A total of 2803 adults were referred for assessment over the study period. There was an absolute increase in completions among those who started a treatment of 19.0% at the end of the study between the observed intervention completion rate and the projected completion rate from the baseline study period (the completion rate had the 3HP intervention not been introduced) (76% observed vs 57% projected; 95% CI 6.6 to 31.4%; p = 0.004) and an absolute increase among those who were offered treatment (17.3%; 95% CI, 2.3 to 32.3%; p = 0.025).
CONCLUSIONS


The introduction of 3HP for TPT as an alternative to the regular regimens offered resulted in a significant increase in the proportion of patients completing treatment. Our study provides evidence to support accelerated use of 3HP in Canada.",2022,"(76% observed vs 57% projected, 95% CI 6.6 to 31.4%, p = 0.004) and an absolute increase among those who were offered treatment of 17.3% 95% CI, 2.3 to 32.3%, p = 0.025).
","['2803 adults were referred for assessment over the study period', 'consecutive adults referred to a TB clinic from January 2010 to May 2019', 'patients completing TB preventive treatment (TPT) above the baseline rate']",['isoniazid or 4 months of daily rifampin'],['proportion who completed TPT'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",2803.0,0.117475,"(76% observed vs 57% projected, 95% CI 6.6 to 31.4%, p = 0.004) and an absolute increase among those who were offered treatment of 17.3% 95% CI, 2.3 to 32.3%, p = 0.025).
","[{'ForeName': 'Gonzalo G', 'Initials': 'GG', 'LastName': 'Alvarez', 'Affiliation': 'Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. Electronic address: galvarez@ohri.ca.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pease', 'Affiliation': 'Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Van Dyk', 'Affiliation': 'Inuit Tapariit Kanatami, Ottawa, Ontario, Canada.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'School of Public Health, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kanchana', 'Initials': 'K', 'LastName': 'Amaratunga', 'Affiliation': 'Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Ontario, Canada; Public Health Agency of Canada, Ottawa, Ontario, Canada.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Allen', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Brethour', 'Affiliation': 'School of Public Health, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Mulpuru', 'Affiliation': 'Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Pakhale', 'Affiliation': 'Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Shawn D', 'Initials': 'SD', 'LastName': 'Aaron', 'Affiliation': 'Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'D William', 'Initials': 'DW', 'LastName': 'Cameron', 'Affiliation': 'Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Alsdurf', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada; McGill International Tuberculosis Centre, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Hui', 'Affiliation': ""School of Medicine, University of Ottawa, Ottawa, Ontario, Canada; Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Alice A', 'Initials': 'AA', 'LastName': 'Zwerling', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada; McGill International Tuberculosis Centre, McGill University Health Centre, Montreal, Quebec, Canada.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2022.01.063']
1922,35123483,Evaluation of the effect of tofogliflozin on the tissue characteristics of the carotid wall-a sub-analysis of the UTOPIA trial.,"BACKGROUND


Since sodium-glucose cotransporter 2 (SGLT2) inhibitors have a pleiotropic antiatherogenic effect, they are expected to attenuate the progression of atherosclerosis. However, whether SGLT2 inhibitors affect the tissue characteristics of the human arterial wall remains unclear. This study aimed to evaluate the effects of tofogliflozin, a selective SGLT2 inhibitor, on the tissue characteristics of the human arterial wall in type 2 diabetes (T2DM) patients without apparent cardiovascular disease (CVD).
METHODS


The present study was a post hoc analysis based on data obtained from the Using Tofogliflozin for Possible Better Intervention against Atherosclerosis for Type 2 Diabetes Patients (UTOPIA) trial, which was a multicenter prospective, randomized, open-label, blinded-endpoint study conducted to evaluate the efficacy of tofogliflozin in preventing the progression of atherosclerosis in patients with T2DM. We evaluated the longitudinal change in the ultrasonic tissue characteristics of the carotid wall using gray-scale median (GSM), an established index of ultrasonic tissue characteristics. The right and left intima-medial areas were delineated, and the GSM values were evaluated (right GSM-CCA and left GSM-CCA). The average values of the right and left carotid arteries were defined as ""mean GSM-CCA value.""
RESULTS


In a mixed-effects model for repeated measures, mean GSM-CCA, along with the right and left GSM-CCA values, did not significantly change in either the tofogliflozin (n = 168) or conventional treatment group (n = 169). In addition, the tofogliflozin and conventional treatment groups did not significantly differ regarding the change of the mean GSM-CCA (mean difference [95% CI] - 1.24[- 3.87, 1.38], P = 0.35), along with the right (mean difference [95% CI] - 2.33[- 5.70, 1.05], P = 0.18) and the left GSM-CCA (mean difference [95% CI] - 0.29 [- 3.53, 2.95], P = 0.86) values. Similar findings were obtained even after adjusting for traditional cardiovascular risk factors and/or the administration of drugs at baseline.
CONCLUSIONS


The tissue characteristics of the carotid arterial wall did not change in either the tofogliflozin or conventional treatment group during the 104-week treatment period, and there was no significant difference between the treatment groups. Clinical trial registration UMIN000017607 ( https://www.umin.ac.jp/icdr/index.html ).",2022,"The tissue characteristics of the carotid arterial wall did not change in either the tofogliflozin or conventional treatment group during the 104-week treatment period, and there was no significant difference between the treatment groups.","['type 2 diabetes (T2DM) patients without apparent cardiovascular disease (CVD', 'patients with T2DM', 'Type 2 Diabetes Patients (UTOPIA) trial']","['Tofogliflozin', 'SGLT2 inhibitors', 'tofogliflozin']","['left GSM-CCA', 'mean GSM-CCA', 'average values of the right and left carotid arteries', 'tissue characteristics of the carotid arterial wall']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0220668', 'cui_str': 'Congenital contractural arachnodactyly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0507850', 'cui_str': 'Wall of artery'}]",,0.0461533,"The tissue characteristics of the carotid arterial wall did not change in either the tofogliflozin or conventional treatment group during the 104-week treatment period, and there was no significant difference between the treatment groups.","[{'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Katakami', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan. katakami@endmet.med.osaka-u.ac.jp.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Mita', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Maeda', 'Affiliation': 'Department of Metabolism and Atherosclerosis, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, 45 Shinanomachi Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism and Atherosclerosis, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Iichiro', 'Initials': 'I', 'LastName': 'Shimomura', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular diabetology,['10.1186/s12933-022-01451-6']
1923,35124228,Modulating social feedback processing by deep TMS targeting the medial prefrontal cortex: Behavioral and electrophysiological manifestations.,"Neuroimaging studies have suggested that the medial prefrontal cortex (mPFC) is a key brain region for social feedback processing, but previous findings are largely based on correlational approaches. In this study, we use the deep transcranial magnetic stimulation (dTMS) to manipulate mPFC activity, then investigate participants' behavioral performance and event-related potentials (ERPs) during the Social Judgment Paradigm. A between-subject design was applied, such that both the active dTMS group and the sham group consisted of 30 participants. We found that the sham group was more likely to predict that they would be socially accepted (rather than rejected) by peers, but the same was not true in the active group. Additionally, this study is the first one to observe ERP signal changes in response to dTMS manipulation. ERP results show that both the expectation stage and the experience stage of social feedback processing were modulated by dTMS: (1) at the expectation stage, the P1 component was smaller in the active group than the sham group, while the stimulus-preceding negativity showed a stronger differentiating effect between positive and negative prediction in the sham group than the active group; (2) at the experience stage, the sensitivity of the late positive potential to the valence and predictability of social feedback was stronger in the sham group than the active group. These results improve our understanding about the relationship between the mPFC and social feedback processing.",2022,"We found that the sham group were more likely to predict that they would be socially accepted (rather than rejected) by peers, but the same was not true in the active group.",[],['deep transcranial magnetic stimulation (dTMS'],"['experience stage of social feedback processing', ""participants' behavioral performance and event-related potentials (ERPs"", 'valence and predictability of social feedback', 'P1 component']",[],"[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",30.0,0.0603788,"We found that the sham group were more likely to predict that they would be socially accepted (rather than rejected) by peers, but the same was not true in the active group.","[{'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen 518060, China; Institute of Brain and Psychological Sciences, Sichuan Normal University, Chengdu 610066, China; Magnetic Resonance Imaging (MRI) Center, Shenzhen University, Shenzhen 518060, China. Electronic address: zhangdd05@gmail.com.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Ao', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen 518060, China.'}, {'ForeName': 'Zixin', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen 518060, China.'}, {'ForeName': 'Junshi', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen 518060, China.'}, {'ForeName': 'Yueyao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen 518060, China.'}, {'ForeName': 'Ruolei', 'Initials': 'R', 'LastName': 'Gu', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology, Beijing 100101, China; Department of Psychology, University of Chinese Academy of Sciences, Beijing 100049, China. Electronic address: gurl@psych.ac.cn.'}]",NeuroImage,['10.1016/j.neuroimage.2022.118967']
1924,35124187,Investigators' sense of failure thwarted transparency in clinical trials discontinued for poor recruitment.,"BACKGROUND AND OBJECTIVE


When a randomized clinical trial (RCT) prematurely discontinues, it is essential that stakeholders do the right thing to ensure that lessons can be learnt and trust in clinical research is maintained. There is, however, a lack of evidence exploring this issue. This study aimed to examine clinical trial stakeholders' practices following trial discontinuation due to poor participant recruitment and their views on implications of such discontinuation.
METHODS


Individual semi-structured qualitative interviews were conducted with 49 clinical trial stakeholders from Switzerland (n = 39), Germany (n = 9) and Canada (n = 1) between August 2015 and November 2016.
RESULTS


After interviews with 49 clinical trial stakeholders (75% male presenting), it was found that stakeholders were aware of the risks of premature trial discontinuation wasting limited resources, adversely impacting scientific evidence, and having negative personal and professional implications. However, barriers continue to undermine transparency regarding trial discontinuation in practice, with it being reported that most investigators of discontinued trials are failing to notify stakeholders or publishing their results. Investigators sense of failure and associated negative emotions were identified as a key reason why investigators are not more transparent following discontinuation.
CONCLUSION


The decision to notify stakeholders and publish results of a discontinued clinical trial should not rest solely on individual investigators but come from a systemic approach. However, until health research proactively requires the dissemination of results of all clinical trials, much will rest on individual investigators being motivated to do the right thing. Support programs might be helpful for investigators involved in discontinued trials and promote transparency and learning lessons.",2022,"After interviews with 49 clinical trial stakeholders (75% male presenting), it was found that stakeholders were aware of the risks of premature trial discontinuation wasting limited resources, adversely impacting scientific evidence, and having negative personal and professional implications.","['Individual semi-structured qualitative interviews were conducted with 49 clinical trial stakeholders from Switzerland (n=39), Germany (n=9) and Canada (n=1) between August 2015 and November 2016']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]",[],[],,0.339372,"After interviews with 49 clinical trial stakeholders (75% male presenting), it was found that stakeholders were aware of the risks of premature trial discontinuation wasting limited resources, adversely impacting scientific evidence, and having negative personal and professional implications.","[{'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Satalkar', 'Affiliation': 'Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Basel, Switzerland; Department of Public Health, Institute for Biomedical Ethics, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'McLennan', 'Affiliation': 'Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Basel, Switzerland; Institute of History and Ethics in Medicine, TUM School of Medicine, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Bernice S', 'Initials': 'BS', 'LastName': 'Elger', 'Affiliation': 'Department of Public Health, Institute for Biomedical Ethics, University of Basel, Basel, Switzerland; Center for Legal Medicine, Unit for Health Law and Humanitarian Medicine, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'von Elm', 'Affiliation': 'Cochrane Switzerland, Centre for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Briel', 'Initials': 'B', 'LastName': 'Matthias', 'Affiliation': 'Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Basel, Switzerland; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada. Electronic address: Matthias.Briel@usb.ch.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2022.01.024']
1925,35129113,Endometrial scratch to increase live birth rates in women undergoing first-time in vitro fertilisation: RCT and systematic review.,"BACKGROUND


In vitro fertilisation is a widely used reproductive technique that can be undertaken with or without intracytoplasmic sperm injection. The endometrial scratch procedure is an in vitro fertilisation 'add-on' that is sometimes provided prior to the first in vitro fertilisation cycle, but there is a lack of evidence to support its use.
OBJECTIVES


(1) To assess the clinical effectiveness, safety and cost-effectiveness of endometrial scratch compared with treatment as usual in women undergoing their first in vitro fertilisation cycle (the 'Endometrial Scratch Trial') and (2) to undertake a systematic review to combine the results of the Endometrial Scratch Trial with those of previous trials in which endometrial scratch was provided prior to the first in vitro fertilisation cycle.
DESIGN


A pragmatic, multicentre, superiority, open-label, parallel-group, individually randomised controlled trial. Participants were randomised (1 : 1) via a web-based system to receive endometrial scratch or treatment as usual using stratified block randomisation. The systematic review involved searching electronic databases (undertaken in January 2020) and clinicaltrials.gov (undertaken in September 2020) for relevant trials.
SETTING


Sixteen UK fertility units.
PARTICIPANTS


Women aged 18-37 years, inclusive, undergoing their first in vitro fertilisation cycle. The exclusion criteria included severe endometriosis, body mass index ≥ 35 kg/m 2  and previous trauma to the endometrium.
INTERVENTIONS


Endometrial scratch was undertaken in the mid-luteal phase of the menstrual cycle prior to in vitro fertilisation, and involved inserting a pipelle into the cavity of the uterus and rotating and withdrawing it three or four times. The endometrial scratch group then received usual in vitro fertilisation treatment. The treatment-as-usual group received usual in vitro fertilisation only.
MAIN OUTCOME MEASURES


The primary outcome was live birth after completion of 24 weeks' gestation within 10.5 months of egg collection. Secondary outcomes included implantation, pregnancy, ectopic pregnancy, miscarriage, pain and tolerability of the procedure, adverse events and treatment costs.
RESULTS


One thousand and forty-eight (30.3%) women were randomised to treatment as usual ( n  = 525) or endometrial scratch ( n  = 523) and were followed up between July 2016 and October 2019 and included in the intention-to-treat analysis. In the endometrial scratch group, 453 (86.6%) women received the endometrial scratch procedure. A total of 494 (94.1%) women in the treatment-as-usual group and 497 (95.0%) women in the endometrial scratch group underwent in vitro fertilisation. The live birth rate was 37.1% (195/525) in the treatment-as-usual group and 38.6% (202/523) in the endometrial scratch group: an unadjusted absolute difference of 1.5% (95% confidence interval -4.4% to 7.4%;  p  = 0.621). There were no statistically significant differences in secondary outcomes. Safety events were comparable across groups. No neonatal deaths were recorded. The cost per successful live birth was £11.90 per woman (95% confidence interval -£134 to £127). The pooled results of this trial and of eight similar trials found no evidence of a significant effect of endometrial scratch in increasing live birth rate (odds ratio 1.03, 95% confidence interval 0.87 to 1.22).
LIMITATIONS


A sham endometrial scratch procedure was not undertaken, but it is unlikely that doing so would have influenced the results, as objective fertility outcomes were used. A total of 9.2% of women randomised to receive endometrial scratch did not undergo the procedure, which may have slightly diluted the treatment effect.
CONCLUSIONS


We found no evidence to support the theory that performing endometrial scratch in the mid-luteal phase in women undergoing their first in vitro fertilisation cycle significantly improves live birth rate, although the procedure was well tolerated and safe. We recommend that endometrial scratch is not undertaken in this population.
TRIAL REGISTRATION


This trial is registered as ISRCTN23800982.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 26, No. 10. See the NIHR Journals Library website for further project information.",2022,"Secondary outcomes included implantation, pregnancy, ectopic pregnancy, miscarriage, pain and tolerability of the procedure, adverse events and treatment costs.
","['A total of 494 (94.1%) women in the treatment-as-usual group and 497 (95.0%) women in the endometrial scratch group underwent in vitro fertilisation', 'Women aged 18-37 years, inclusive, undergoing their first in vitro fertilisation cycle', 'Sixteen UK fertility units', ""women undergoing their first in vitro fertilisation cycle (the 'Endometrial Scratch Trial') and (2"", ' n \u2009=\u2009523) and were followed up between July 2016 and October 2019 and included in the intention-to-treat analysis', 'women undergoing first-time in vitro fertilisation']","['usual in vitro fertilisation only', 'endometrial scratch', 'web-based system to receive endometrial scratch or treatment as usual using stratified block randomisation']","['implantation, pregnancy, ectopic pregnancy, miscarriage, pain and tolerability of the procedure, adverse events and treatment costs', 'clinical effectiveness, safety and cost-effectiveness', 'Endometrial scratch', ""live birth after completion of 24 weeks' gestation"", 'live birth rate', 'cost per successful live birth', 'Safety events', 'live birth rates', 'neonatal deaths', 'tolerated and safe']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032987', 'cui_str': 'Ectopic pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}]",,0.368203,"Secondary outcomes included implantation, pregnancy, ectopic pregnancy, miscarriage, pain and tolerability of the procedure, adverse events and treatment costs.
","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Metwally', 'Affiliation': 'Assisted Conception Unit, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Chatters', 'Affiliation': 'Sheffield Clinical Trials Research Unit (CTRU), School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Pye', 'Affiliation': 'Assisted Conception Unit, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Munya', 'Initials': 'M', 'LastName': 'Dimairo', 'Affiliation': 'Sheffield Clinical Trials Research Unit (CTRU), School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Sheffield Clinical Trials Research Unit (CTRU), School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Walters', 'Affiliation': 'Design, Trials and Statistics, School of Health and Related Research (ScHARR), Sheffield, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'Hull Health Trials Unit, University of Hull, Hull, UK.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Young', 'Affiliation': 'Health Economic and Decision Science, School of Health and Related Research (ScHARR), Sheffield, UK.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheong', 'Affiliation': 'Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Laird', 'Affiliation': 'Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Lamiya', 'Initials': 'L', 'LastName': 'Mohiyiddeen', 'Affiliation': ""Saint Mary's Hospital, Manchester University NHS Foundation Trust, Manchester, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chater', 'Affiliation': 'Sheffield Clinical Trials Research Unit (CTRU), School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Pemberton', 'Affiliation': 'Sheffield Clinical Trials Research Unit (CTRU), School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Turtle', 'Affiliation': 'Sheffield Clinical Trials Research Unit (CTRU), School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Hall', 'Affiliation': 'Sheffield Clinical Trials Research Unit (CTRU), School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'Assisted Conception Unit, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Brian', 'Affiliation': 'Fertility Network UK, Greenwich, UK.'}, {'ForeName': 'Anya', 'Initials': 'A', 'LastName': 'Sizer', 'Affiliation': 'Fertility Network UK, Greenwich, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hunter', 'Affiliation': ""Department of Reproductive Medicine, Old St Mary's Hospital, Manchester, UK.""}]","Health technology assessment (Winchester, England)",['10.3310/JNZT9406']
1926,35130291,Long-term data on the proposed adalimumab biosimilar BCD-057 in patients with moderate to severe psoriasis: A randomized controlled trial.,"INTRODUCTION


The objective of this study was to demonstrate that BCD-057 is similar to innovator adalimumab (iADA) in terms of efficacy, safety, and pharmacokinetics in steady state in the target population of patients with moderate to severe plaque psoriasis (NCT02762955).
METHODS


Patients were randomized in 1:1 ratio to receive 80 mg of BCD-057 or iADA at week 0 and 40 mg thereafter every other week from week 1. At week 24 patients from iADA group were re-randomized (1:1) to continue iADA or to be switched to BCD-057. The primary efficacy endpoint was 75% improvement in Psoriasis Area and Severity Index from baseline (PASI 75), secondary endpoints included PASI percent improvement and relative change in affected Body Surface Area (BSA) from baseline at weeks 16, 24, 33, and 55. Safety was assessed through monitoring of adverse events (AEs) and antidrug antibodies. Pharmacokinetics was evaluated at steady state.
RESULTS


Overall, 346 adult patients were included in the study (174/172 patients in BCD-057/iADA arms, respectively). At week 16 PASI 75 was achieved by 60.34% and 63.37% of patients in BCD-057 and iADA arms, respectively (p = 0.5622). Bounds of the calculated 95% confidence interval (CI) for the difference between PASI 75 responses in arms [-13.26%; 7.2%] fall within the equivalence margin [-15% to 15%] demonstrating equivalent efficacy of BCD-057 and iADA. At week 55 81.61%, 85.56%, and 80.49% of patients in BCD-057, iADA and iADA/BCD-057 arms achieved PASI 75. Comparison of the secondary endpoints did not show significant differences between arms. A comparable pharmacokinetics was shown at steady state. Safety profiles and proportions of patients with antidrug antibodies were similar between arms. The switch from the iADA to BCD-057 did not affect the immunogenicity profile.
CONCLUSION


Obtained data demonstrate that BCD-057 and iADA are highly similar in clinical efficacy, pharmacokinetics, safety, and immunogenicity in patients with moderate to severe plaque psoriasis.",2022,"At week 16 PASI 75 was achieved by 60.34% and 63.37% of patients in BCD-057 and iADA arms, respectively (p = 0.5622).","['patients with moderate to severe psoriasis', 'patients with moderate to severe plaque psoriasis (NCT02762955', 'Patients', '346 adult patients were included in the study (174/172 patients in BCD-057/iADA arms, respectively', 'patients with moderate to severe plaque psoriasis']","['BCD-057', 'adalimumab biosimilar', 'BCD-057 or iADA', 'continue iADA or to be switched to BCD-057']","['adverse events (AEs) and antidrug antibodies', 'immunogenicity profile', 'clinical efficacy, pharmacokinetics, safety, and immunogenicity', 'Psoriasis Area and Severity Index', 'PASI percent improvement and relative change in affected Body Surface Area (BSA', 'Safety profiles and proportions of patients with antidrug antibodies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0053048', 'cui_str': 'BCD protocol'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0053048', 'cui_str': 'BCD protocol'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",346.0,0.101994,"At week 16 PASI 75 was achieved by 60.34% and 63.37% of patients in BCD-057 and iADA arms, respectively (p = 0.5622).","[{'ForeName': 'Alexey V', 'Initials': 'AV', 'LastName': 'Samtsov', 'Affiliation': 'Department of Dermatology, S.M. Kirov Military Medical Academy, Saint-Petersburg, Russia.'}, {'ForeName': 'Andrey L', 'Initials': 'AL', 'LastName': 'Bakulev', 'Affiliation': 'Department of Dermatology, V.I. Razumovskiy Saratov State Medical University, Saratov, Russia.'}, {'ForeName': 'Vladislav R', 'Initials': 'VR', 'LastName': 'Khairutdinov', 'Affiliation': 'Department of Dermatology, S.M. Kirov Military Medical Academy, Saint-Petersburg, Russia.'}, {'ForeName': 'Muza M', 'Initials': 'MM', 'LastName': 'Kokhan', 'Affiliation': 'Scientific Clinical Department, Ural Research Institute of Dermatovenereology and Immunopathology, Yekaterinburg, Russia.'}, {'ForeName': ""Tat'yana V"", 'Initials': 'TV', 'LastName': 'Korotaeva', 'Affiliation': 'Spondyloarthritis and Psoriatic Arthritis Laboratory, V.A. Nasonova Research Institute for Rheumatology, Moscow, Russia.'}, {'ForeName': 'Iskander K', 'Initials': 'IK', 'LastName': 'Minullin', 'Affiliation': 'Head of Institution, Republican Clinical Dermatology and Venereology Clinic, Kazan, Russia.'}, {'ForeName': 'Olga A', 'Initials': 'OA', 'LastName': 'Vylegzhanina', 'Affiliation': 'Diagnostic Center, Siberian Regional Medical Center of the Federal Medical and Biological Agency, Novosibirsk, Russia.'}, {'ForeName': 'Valery V', 'Initials': 'VV', 'LastName': 'Dubenskiy', 'Affiliation': 'Dermatovenerology Department, Tver State Medical University, Tver, Russia.'}, {'ForeName': 'Bulat V', 'Initials': 'BV', 'LastName': 'Khalilov', 'Affiliation': 'Dermatovenerology Department, Kazan State Medical University, Kazan, Russia.'}, {'ForeName': 'Alkes A', 'Initials': 'AA', 'LastName': 'Khotko', 'Affiliation': 'Department of Dermatology, Clinical Dermatology and Venereology Clinic of the Ministry of Healthcare of Krasnodar Region, Krasnodar, Russia.'}, {'ForeName': 'Olga S', 'Initials': 'OS', 'LastName': 'Zykova', 'Affiliation': 'Department of Dermatology, Vitebsk Regional Clinical Center for Dermatology, Venereology and Cosmetology, Vitebsk, Republic of Belarus.'}, {'ForeName': 'Irina V', 'Initials': 'IV', 'LastName': 'Chumachenko', 'Affiliation': 'Department of Dermatology, Mogilev Regional Dermatology and Venereology Clinic, Mogilev, Republic of Belarus.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Lukyanov', 'Affiliation': 'Department of Dermatology, City Clinical Dermatology and Venereology Clinic, Minsk, Republic of Belarus.'}, {'ForeName': 'Antonina V', 'Initials': 'AV', 'LastName': 'Artemeva', 'Affiliation': 'Clinical research department, JSC BIOCAD, Saint Petersburg, Russia.'}, {'ForeName': 'Polina P', 'Initials': 'PP', 'LastName': 'Pukhtinskaia', 'Affiliation': 'Clinical research department, JSC BIOCAD, Saint Petersburg, Russia.'}]",PloS one,['10.1371/journal.pone.0263214']
1927,35131378,Enhancing diabetes care with community pharmacist-involved collaborative care model: A multi-centre randomised controlled trial.,"AIM


To evaluate the clinical and humanistic outcomes of a community pharmacist-involved collaborative care model in diabetes management.
METHODS


This was a parallel arm, open-label, multi-centre randomized controlled trial conducted over 6 months. Subjects with type 2 diabetes, HbA1c ≥ 7.0% (53 mmol/mol) and taking ≥ 5 medications were included. Participants were randomized into intervention (collaborative care) and control groups (physician-centric care). The intervention included medication therapy management and telephonic follow-up with visits to family physicians, nurses, and dietitians. Clinical outcomes included changes in HbA1c, systolic blood pressure (SBP), lipids, and hypoglycaemic incidences. Humanistic outcomes included self-care capabilities and quality of life. Linear mixed models were constructed. Intention-to-treat analyses, with sensitivity analyses, were conducted.
RESULTS


A total of 264 participants were randomized (intervention: 131, control: 133). Significantly greater reduction in HbA1c was observed in the intervention group (intervention: -0.32% (-3.52 mmol/mol) vs. control: -0.06% (-0.66 mmol/mol), p = 0.038). Changes in SBP, lipids, and incidences of hypoglycaemia were not significant over 6 months between both groups. Significantly greater improvements in self-management (p < 0.001) and quality of life (p = 0.003) were observed within the intervention group.
CONCLUSION


Partnering community pharmacists in a collaborative care team improved glycaemic control, quality of life and self-care capabilities of patients with diabetes and polypharmacy.",2022,"Significantly greater improvements in self-management (p<0.001) and quality of life (p=0.003) were observed within the intervention group.
","['patients with diabetes and polypharmacy', '264 participants were randomized (intervention: 131, control: 133', 'Enhancing Diabetes Care with Community Pharmacist-Involved Collaborative Care Model', 'diabetes management', 'Subjects with type 2 diabetes, HbA1c≥7.0% (53 mmol/mol) and taking ≥5 medications were included']","['community pharmacist-involved collaborative care model', 'medication therapy management and telephonic follow-up with visits to family physicians, nurses, and dietitians']","['self-management (p<0.001) and quality of life', 'HbA1c', 'self-care capabilities and quality of life', 'glycaemic control, quality of life and self-care capabilities', 'Changes in SBP, lipids, and incidences of hypoglycaemia', 'changes in HbA1c, systolic blood pressure (SBP), lipids, and hypoglycaemic incidences']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0402003', 'cui_str': 'Community pharmacist'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0402003', 'cui_str': 'Community pharmacist'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1611232', 'cui_str': 'Drug Therapy Management'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}]",264.0,0.0529512,"Significantly greater improvements in self-management (p<0.001) and quality of life (p=0.003) were observed within the intervention group.
","[{'ForeName': 'Zheng Kang', 'Initials': 'ZK', 'LastName': 'Lum', 'Affiliation': 'Department of Pharmacy, National University of Singapore, Singapore.'}, {'ForeName': 'Kai Li', 'Initials': 'KL', 'LastName': 'Chang', 'Affiliation': 'Department of Pharmacy, National University of Singapore, Singapore.'}, {'ForeName': 'Keith Yu-Kei', 'Initials': 'KY', 'LastName': 'Tsou', 'Affiliation': 'National University Polyclinics, Singapore.'}, {'ForeName': 'Jia Yeong', 'Initials': 'JY', 'LastName': 'Tan', 'Affiliation': 'Keat Hong Family Medicine Clinic, Singapore.'}, {'ForeName': 'Cynthia Sze Mun', 'Initials': 'CSM', 'LastName': 'Wong', 'Affiliation': 'National University Polyclinics, Singapore.'}, {'ForeName': 'Zi Yin', 'Initials': 'ZY', 'LastName': 'Kok', 'Affiliation': 'Keat Hong Family Medicine Clinic, Singapore.'}, {'ForeName': 'Sing Cheer', 'Initials': 'SC', 'LastName': 'Kwek', 'Affiliation': 'National University Polyclinics, Singapore.'}, {'ForeName': 'Paul John', 'Initials': 'PJ', 'LastName': 'Gallagher', 'Affiliation': 'Department of Pharmacy, National University of Singapore, Singapore. Electronic address: phapjg@nus.edu.sg.'}, {'ForeName': 'Joyce Yu-Chia', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'School of Pharmacy and Pharmaceutical Sciences, University of California, Irvine, USA. Electronic address: j.lee@uci.edu.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2022.109238']
1928,35131363,"Vortioxetine 5, 10, and 20 mg significantly reduces the risk of relapse compared with placebo in patients with remitted major depressive disorder: The RESET study.","BACKGROUND


Maintenance therapy for major depressive disorder (MDD) is typically recommended at the dose on which the patient was stabilized. However, for some patients, dose alteration may be required. We investigated multiple vortioxetine doses versus placebo for relapse prevention in patients achieving remission with vortioxetine 10 mg daily.
METHODS


In this US-based, randomized withdrawal study, outpatients (N = 1106, aged 18-75 years) with recurrent MDD (Montgomery-Åsberg Depression Rating Scale [MADRS] score ≥26), a current major depressive episode (MDE) (8 weeks-18 months' duration), and ≥2 previous MDEs were treated with open-label vortioxetine 10 mg once daily orally for 16 weeks. Responders at week 8 (≥50% MADRS score reduction) achieving remission (MADRS score ≤12) at weeks 14 and 16 (N = 580) were randomized to vortioxetine 5, 10, or 20 mg or placebo in a 32-week double-blind period. The primary outcome was time to first relapse over the first 28 weeks; secondary outcomes (relapse, change in total MADRS, Clinician Global Impression-Severity [CGI-S]) were evaluated at 32 weeks.
RESULTS


Time to relapse was longer and cumulative relapse rates were lower for vortioxetine 5 mg (19.3%), 10 mg (17.9%), and 20 mg (17.4%) versus placebo (32.5%) over 28 weeks (p<0.05 for all). CGI-S scores remained stable and adverse events were generally mild-to-moderate.
LIMITATIONS


Extrapolation of results to patients achieving remission with vortioxetine doses other than 10 mg should be made with caution.
CONCLUSION


For patients with MDD achieving symptomatic remission at 10 mg/day, all doses of vortioxetine were effective for relapse prevention, with acceptable tolerability.",2022,"RESULTS


Time to relapse was longer and cumulative relapse rates were lower for vortioxetine 5 mg (19.3%), 10 mg (17.9%), and 20 mg (17.4%) versus placebo (32.5%) over 28 weeks (p<0.05 for all).","['patients achieving remission with vortioxetine 10 mg daily', 'major depressive disorder (MDD', ""outpatients (N=1106, aged 18-75 years) with recurrent MDD (Montgomery-Åsberg Depression Rating Scale [MADRS] score ≥26), a current major depressive episode (MDE) (8 weeks-18 months' duration), and ≥2 previous MDEs were treated with"", 'Patients With Remitted Major Depressive Disorder']","['placebo', 'Placebo', 'vortioxetine', 'open-label vortioxetine', 'Vortioxetine']","['Risk of Relapse', 'time to first relapse over the first 28 weeks; secondary outcomes (relapse, change in total MADRS, Clinician Global Impression-Severity [CGI-S', 'symptomatic remission', 'CGI-S scores remained stable and adverse events', 'cumulative relapse rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3692162', 'cui_str': 'vortioxetine 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0047006', 'cui_str': 'Methylenedioxyethylamphetamine'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.246808,"RESULTS


Time to relapse was longer and cumulative relapse rates were lower for vortioxetine 5 mg (19.3%), 10 mg (17.9%), and 20 mg (17.4%) versus placebo (32.5%) over 28 weeks (p<0.05 for all).","[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, PA, US.'}, {'ForeName': 'Paula L', 'Initials': 'PL', 'LastName': 'Jacobsen', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, MA US.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hanson', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, MA US.'}, {'ForeName': 'Rengyi', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, MA US.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Tolkoff', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, MA US.'}, {'ForeName': 'Naga Venkatesha', 'Initials': 'NV', 'LastName': 'Murthy', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, MA US. Electronic address: venkatesha.murthy2@takeda.com.'}]",Journal of affective disorders,['10.1016/j.jad.2022.02.002']
1929,35131719,Pravastatin may improve neurological outcome following low-grade aneurysmal subarachnoid hemorrhage.,"Statins may improve outcome in patients with aneurysmal subarachnoid hemorrhage (aSAH) but randomized controlled trials, including all patients with aSAH whatever their clinical severity, were negative. We studied whether pravastatin improved neurologic outcome in patients with early good neurological status, whose prognosis is related to secondary lesions as delayed cerebral ischemia (DCI). We conducted a single-center study of cases and historical controls in a neurocritical care unit. We included consecutive patients with aSAH from 2011 to 2016 with early good neurological status defined by a WFNS score ≤ 3 on the third day. Patients treated before 2014 with oral pravastatin (40 mg/day for 14 days) as a standard of care were matched using propensity score to patients treated after 2014 without pravastatin. Good neurologic outcome was defined by a Glasgow Outcome Scale ≥ 4 at neurocritical care unit discharge. We included 270 patients (135 patients with pravastatin), mostly treated with coiling (94.1%). Demographic, initial and subacute features were the same in the 2 groups. More patients experienced good outcome in the pravastatin group than in the control group (94.8% vs 74.2%; OR 7.16 95% CI [3.07 - 16.72], p < 0.001). There was no difference in the occurrence of DCI in the 2 groups. In our study, outcome on neurocritical care discharge was better in patients with early good neurological status treated with pravastatin. Another randomized controlled trial should be conducted on this subtype of population.",2022,"More patients experienced good outcome in the pravastatin group than in the control group (94.8% vs 74.2%; OR 7.16 95% CI [3.07 - 16.72], p < 0.001).","['patients with early good neurological status', 'patients with early good neurological status treated with', 'consecutive patients with aSAH from 2011 to 2016 with early good neurological status defined by a WFNS score\xa0≤\xa03 on the third day', 'cases and historical controls in a neurocritical care unit', 'low-grade aneurysmal subarachnoid hemorrhage', '270 patients (135 patients with pravastatin), mostly treated with coiling (94.1', 'patients with aneurysmal subarachnoid hemorrhage (aSAH']","['Statins', 'oral pravastatin', 'Pravastatin', 'pravastatin']","['Good neurologic outcome', 'neurological outcome', 'neurocritical care discharge', 'occurrence of DCI', 'neurologic outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0746866', 'cui_str': 'Neurological status'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}]",270.0,0.0377293,"More patients experienced good outcome in the pravastatin group than in the control group (94.8% vs 74.2%; OR 7.16 95% CI [3.07 - 16.72], p < 0.001).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mazard', 'Affiliation': 'Intensive Care Unit, Croix Rousse University Hospital, 103 Grande Rue de la Croix-Rousse, 69004 Lyon, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ritzenthaler', 'Affiliation': 'Neurocritical Care Unit, Pierre Wertheimer Hospital, 59 Boulevard Pinel, 69500 Bron, France. Electronic address: thomas.ritzenthaler@chu-lyon.fr.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dailler', 'Affiliation': 'Neurocritical Care Unit, Pierre Wertheimer Hospital, 59 Boulevard Pinel, 69500 Bron, France.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2022.01.025']
1930,35133884,"Efficacy and Safety of Blonanserin Oral Tablet in Adolescents with Schizophrenia: A 6-Week, Randomized Placebo-Controlled Study.","Objectives:  To evaluate the short-term efficacy and safety of blonanserin in adolescents with schizophrenia.  Methods:  This 6-week multicenter, double-blind, randomized, placebo-controlled study investigated fixed-dose blonanserin (8 or 16 mg/day) in patients 12-18 years of age diagnosed with schizophrenia, as indicated by a Positive and Negative Syndrome Scale (PANSS) total score of 60-120 and a Clinical Global Impressions-Severity score of ≥3. The primary endpoint was change from baseline to week 6 in the PANSS total score, using a mixed model for repeated measures analysis. Safety was assessed by the incidence and severity of adverse events (AEs).  Results:  Among 151 randomized patients, 150 were included in the primary analysis population. Demographic and clinical characteristics were similar across groups at baseline. The rate of study discontinuation was 14.9%, 23.5%, and 28.3% in patients administered with placebo, blonanserin 8 mg/day, and blonanserin 16 mg/day, respectively. The least-squares mean change (95% confidence interval [CI]) from baseline to week 6 in PANSS total score was -10.6 (-16.10 to -5.10), -15.3 (-20.80 to -9.86), and -20.5 (-25.89 to -15.16) in patients administered placebo, 8 mg/day blonanserin, and 16 mg/day blonanserin, respectively. The 16-mg/day blonanserin group showed significantly greater reduction in the PANSS total score than the placebo group (least-squares mean difference [95% CI]: -9.9 [-17.61 to -2.25],  p  = 0.012, effect size: 0.538), although the 8-mg/day group showed no significant difference. The incidence of AEs such as akathisia, somnolence, and hyperprolactinemia was higher in the blonanserin groups than in the placebo group. AEs associated with blonanserin were generally mild and were consistent with its known profile in adults with schizophrenia.  Conclusions:  Blonanserin achieved a sufficient efficacy in adolescent patients, and the safety profile was similar to that in adults, which suggests that blonanserin may be a safe treatment option for adolescents with schizophrenia. Study registration number: Japic CTI-111724.",2022,"The incidence of AEs such as akathisia, somnolence, and hyperprolactinemia was higher in the blonanserin groups than in the placebo group.","['Adolescents with Schizophrenia', 'adolescents with schizophrenia', 'adolescent patients', 'Study registration number', 'adults with schizophrenia', '151 randomized patients, 150 were included in the primary analysis population', 'patients 12-18 years of age diagnosed with schizophrenia, as indicated by a Positive and Negative Syndrome Scale (PANSS) total score of 60-120 and a Clinical Global Impressions-Severity score of ≥3']","['placebo', 'placebo, blonanserin', 'Placebo', 'placebo, 8\u2009mg/day blonanserin, and 16\u2009mg/day blonanserin', 'Blonanserin Oral Tablet', 'fixed-dose blonanserin', 'Blonanserin', 'blonanserin']","['incidence of AEs such as akathisia, somnolence, and hyperprolactinemia', 'Safety', 'rate of study discontinuation', 'PANSS total score', 'safety profile', 'incidence and severity of adverse events (AEs', 'Efficacy and Safety']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0993159', 'cui_str': 'Oral tablet'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0020514', 'cui_str': 'Hyperprolactinemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",151.0,0.428089,"The incidence of AEs such as akathisia, somnolence, and hyperprolactinemia was higher in the blonanserin groups than in the placebo group.","[{'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Saori', 'Initials': 'S', 'LastName': 'Sugimoto', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Sakaguchi', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ishigooka', 'Affiliation': 'Institute of CNS Pharmacology, Shibuya-ku, Tokyo, Japan.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2021.0013']
1931,35137022,Feasibility and preliminary efficacy of perioperative interventions in patients undergoing coronary artery bypass grafting: the randomized controlled I-COPE trial.,"OBJECTIVES


Patients undergoing coronary artery bypass graft (CABG) surgery are exposed to multiple treatment-related stressors, which can impact coping and health-related quality of life (HRQoL). The objective of this trial was to analyse the feasibility and preliminary efficacy of a multi-component intervention that combines psychological support and reduction of hospital-specific stressors on HRQoL, length of hospital and intensive care unit stay, self-efficacy, and plasma interleukin (IL)-6 and -8 levels in CABG patients.
METHODS


This three-arm, randomized controlled, single-centre pilot trial assessed the Intervention for CABG to Optimize Patient Experience in 88 patients undergoing elective CABG. Standard medical care (SMC, n = 29) was compared with 2 intervention groups: (i) psychological interventions to optimize treatment expectations (IA group, n = 30) and (ii) multi-component intervention (IB group, n = 29) with psychological interventions plus an additional treatment package (light therapy, noise reduction, music, and if desired, 360° images delivered via virtual reality).
RESULTS


The implementation of psychological interventions in routine medical treatment was feasible (91.5% of participants completed all intervention sessions). Both interventions were associated with significantly shorter hospital stay compared to SMC (IA/IB 9.8/9.3 days vs SMC 12.5 days). Self-efficacy expectations at post-surgery were significantly higher compared to SMC both in the IA group (P = 0.011) and marginally in the IB group (P = 0.051). However, there were no treatment effects of the interventions on HRQoL and plasma levels of IL-6 or IL-8 after CABG.
CONCLUSIONS


A perioperative multi-component intervention may lead to shorter hospital stay and higher self-efficacy after CABG. Further studies are needed to determine its impact on HRQoL and inflammation.
CLINICAL TRIAL REGISTRATION NUMBER


Ethical approval (# 21/2/18) for the study was obtained from the Research Ethics Committee of the University of Göttingen Medical Center, and the trial was registered in the German Clinical Trials Register (DRKS00015309, https://www.drks.de/drks_web/setLocale_EN.do).",2022,"However, there were no treatment effects of the interventions on HRQoL and plasma levels of IL-6 or IL-8 after CABG.
","['patients undergoing coronary artery bypass grafting', '88 patients undergoing elective CABG', 'Patients undergoing', 'CABG patients']","['multi-component intervention', 'perioperative interventions', 'psychological interventions to optimize treatment expectations (IA group, n = 30) and (ii) multi-component intervention (IB group, n = 29) with psychological interventions plus an additional treatment package (light therapy, noise reduction, music, and if desired, 360° images delivered via virtual reality', 'coronary artery bypass graft (CABG) surgery']","['shorter hospital stay', 'Self-efficacy expectations', 'HRQoL, length of hospital and intensive care unit stay, self-efficacy, and plasma interleukin (IL)-6 and -8 levels', 'HRQoL and plasma levels of IL-6 or IL-8']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]",88.0,0.0625266,"However, there were no treatment effects of the interventions on HRQoL and plasma levels of IL-6 or IL-8 after CABG.
","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Sadlonova', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Nagel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'Svenja', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Neumann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Staab', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Celano', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Hermioni L', 'Initials': 'HL', 'LastName': 'Amonoo', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Stella V', 'Initials': 'SV', 'LastName': 'Fangauf', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Herrmann-Lingen', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Kutschka', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Friedrich', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, University Medical Centre Göttingen, Göttingen, Germany.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezac041']
1932,34874631,Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer.,"BACKGROUND


Treatment for patients with recurrent ovarian cancer has been mainly based on systemic therapy. The role of secondary cytoreductive surgery is unclear.
METHODS


We randomly assigned patients with recurrent ovarian cancer who had a first relapse after a platinum-free interval (an interval during which no platinum-based chemotherapy was used) of 6 months or more to undergo secondary cytoreductive surgery and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Patients were eligible if they presented with a positive Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) score, defined as an Eastern Cooperative Oncology Group performance-status score of 0 (on a 5-point scale, with higher scores indicating greater disability), ascites of less than 500 ml, and complete resection at initial surgery. A positive AGO score is used to identify patients in whom a complete resection might be achieved. The primary end point was overall survival. We also assessed quality of life and prognostic factors for survival.
RESULTS


A total of 407 patients underwent randomization: 206 were assigned to cytoreductive surgery and chemotherapy, and 201 to chemotherapy alone. A complete resection was achieved in 75.5% of the patients in the surgery group who underwent the procedure. The median overall survival was 53.7 months in the surgery group and 46.0 months in the no-surgery group (hazard ratio for death, 0.75; 95% confidence interval, 0.59 to 0.96; P = 0.02). Patients with a complete resection had the most favorable outcome, with a median overall survival of 61.9 months. A benefit from surgery was seen in all analyses in subgroups according to prognostic factors. Quality-of-life measures through 1 year of follow-up did not differ between the two groups, and we observed no perioperative mortality within 30 days after surgery.
CONCLUSIONS


In women with recurrent ovarian cancer, cytoreductive surgery followed by chemotherapy resulted in longer overall survival than chemotherapy alone. (Funded by the AGO Study Group and others; DESKTOP III ClinicalTrials.gov number, NCT01166737.).",2021,"Quality-of-life measures through 1 year of follow-up did not differ between the two groups, and we observed no perioperative mortality within 30 days after surgery.
","['women with recurrent ovarian cancer, cytoreductive surgery followed by', '407 patients underwent randomization: 206 were assigned to', 'Relapsed Ovarian Cancer', 'We randomly assigned patients with recurrent ovarian cancer who had a first relapse after a platinum-free interval (an interval during which no platinum-based chemotherapy was used) of 6 months or more to undergo secondary cytoreductive surgery and then receive', 'Patients were eligible if they presented with a positive Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) score, defined as an Eastern Cooperative Oncology Group performance-status score of 0 (on a 5-point scale, with higher scores indicating greater disability), ascites of less than 500 ml, and complete resection at initial surgery', 'patients with recurrent ovarian cancer']","['cytoreductive surgery and chemotherapy, and 201 to chemotherapy alone', 'Cytoreductive Surgery', 'chemotherapy', 'platinum-based chemotherapy or to receive platinum-based chemotherapy alone']","['quality of life and prognostic factors for survival', 'overall survival', 'median overall survival', 'Quality-of-life measures', 'perioperative mortality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",407.0,0.331983,"Quality-of-life measures through 1 year of follow-up did not differ between the two groups, and we observed no perioperative mortality within 30 days after surgery.
","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Ferron', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reuss', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Meier', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Greggi', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Berit J', 'Initials': 'BJ', 'LastName': 'Mosgaard', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Selle', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Guyon', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Pomel', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Lécuru', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Rongyu', 'Initials': 'R', 'LastName': 'Zang', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Avall-Lundqvist', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Ponce', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raspagliesi', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Kristensen', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Classe', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillemanns', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Jensen', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Hasenburg', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Ghaem-Maghami', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Mansoor R', 'Initials': 'MR', 'LastName': 'Mirza', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Lund', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reinthaller', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Santaballa', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Adeola', 'Initials': 'A', 'LastName': 'Olaitan', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hilpert', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2103294']
1933,35123664,"Probiotic peanut oral immunotherapy versus oral immunotherapy and placebo in children with peanut allergy in Australia (PPOIT-003): a multicentre, randomised, phase 2b trial.","BACKGROUND


Oral immunotherapy is effective at inducing desensitisation to allergens and induces sustained unresponsiveness (ie, clinical remission) in a subset of patients, but causes frequent reactions. We aimed to investigate whether addition of a probiotic adjuvant improved the efficacy or safety of peanut oral immunotherapy.
METHODS


PPOIT-003, a multicentre, randomised, phase 2b trial, was conducted in three tertiary hospitals in Australia (Adelaide [SA], Melbourne [VIC], and Perth [WA]) in children aged 1-10 years, weighing more than 7 kg, with peanut allergy confirmed by a double-blind placebo-controlled food challenge (cumulative 4950 mg dose of peanut protein) and positive peanut skin prick test (≥3 mm) or peanut-specific IgE (≥0·35 kU/L). Children were randomly assigned (2:2:1) to receive probiotic and peanut oral immunotherapy (PPOIT), placebo probiotic and peanut oral immunotherapy (OIT), or placebo probiotic and placebo OIT (placebo) for 18 months, and were followed up until 12 months after completion of treatment. Oral immunotherapy consisted of increasing doses of peanut protein (commercially available food-grade 12% defatted peanut flour [50% peanut protein]) until a 2000 mg daily maintenance dose was reached. The probiotic adjuvant was a daily dose of 2 × 10 10  colony-forming units of the probiotic Lactobacillus rhamnosus ATCC 53103. Placebo immunotherapy comprised maltodextrin, brown food colouring, and peanut essence, and placebo probiotic was maltodextrin. Dual primary outcomes were 8-week sustained unresponsiveness, defined as no reaction to a cumulative dose of 4950 mg peanut protein at treatment completion and 8 weeks after treatment completion, in the PPOIT versus placebo groups and the PPOIT versus OIT groups, analysed by intention to treat. Safety endpoints were adverse events during the treatment phase, and peanut ingestion and reactions in the 12-month post-treatment period. This study is registered with the Australian New Zealand Clinical Trials Registry, 12616000322437.
FINDINGS


Between July 4, 2016, and Sept 21, 2020, 201 participants were enrolled and included in the intention-to-treat analysis. 36 (46%) of 79 children in the PPOIT group and 42 (51%) of 83 children in the OIT group achieved sustained unresponsiveness compared with two (5%) of 39 children in the placebo group (risk difference 40·44% [95% CI 27·46 to 53·42] for PPOIT vs placebo, p<0·0001), with no difference between PPOIT and OIT (-5·03% [-20·40 to 10·34], p=0·52). Treatment-related adverse events were reported in 72 (91%) of 79 children in the PPOIT group, 73 (88%) of 83 children in the OIT group, and 28 (72%) of 39 children in the placebo group. Exposure-adjusted incidence of adverse events was 10·58 in the PPOIT group, 11·36 in the OIT, and 2·09 in the placebo group (ratio 0·92 [95% CI 0·85 to 0·99] for PPOIT vs OIT, p=0·042; 4·98 [4·11-6·03] for PPOIT vs placebo, p<0·0001; 5·42 [4·48-6·56] for OIT vs placebo, p<0·0001), with differences seen primarily in gastrointestinal symptoms and in children aged 1-5 years. During the 12-month post-treatment period, 60 (85%) of 71 participants in the PPOIT group, 60 (86%) of 70 participants in the OIT group, and six (18%) of 34 participants in the placebo group were eating peanut; rescue epinephrine use was infrequent (two [3%] of 71 in the PPOIT group, four [6%] of 70 in the OIT group, and none in the placebo group).
INTERPRETATION


Both PPOIT and OIT were effective at inducing sustained unresponsiveness. Addition of a probiotic did not improve efficacy of OIT, but might offer a safety benefit compared with OIT alone, particularly in preschool children.
FUNDING


National Health and Medical Research Council Australia and Prota Therapeutics.",2022,"Treatment-related adverse events were reported in 72 (91%) of 79 children in the PPOIT group, 73 (88%) of 83 children in the OIT group, and 28 (72%) of 39 children in the placebo group.","['three tertiary hospitals in Australia (Adelaide [SA], Melbourne [VIC], and Perth [WA]) in children aged 1-10 years, weighing more than 7 kg, with peanut allergy confirmed by a double-blind', 'Between July 4, 2016, and Sept 21, 2020, 201 participants were enrolled and included in the intention-to-treat analysis', 'children with peanut allergy in Australia (PPOIT-003', 'children aged 1-5 years', 'preschool children']","['probiotic and peanut oral immunotherapy (PPOIT), placebo probiotic and peanut oral immunotherapy (OIT), or placebo probiotic and placebo OIT (placebo', 'placebo', 'probiotic adjuvant', 'peanut protein', 'Probiotic peanut oral immunotherapy versus oral immunotherapy and placebo', 'PPOIT vs placebo', 'placebo-controlled food challenge (cumulative 4950 mg dose of peanut protein) and positive peanut skin prick test (≥3 mm) or peanut-specific IgE (≥0·35 kU/L', 'peanut oral immunotherapy', 'Placebo immunotherapy comprised maltodextrin, brown food colouring, and peanut essence, and placebo probiotic was maltodextrin']","['gastrointestinal symptoms', 'Exposure-adjusted incidence of adverse events', 'eating peanut; rescue epinephrine use', 'sustained unresponsiveness', 'adverse events']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C1270751', 'cui_str': 'Peanut specific immunoglobulin E'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]",201.0,0.707038,"Treatment-related adverse events were reported in 72 (91%) of 79 children in the PPOIT group, 73 (88%) of 83 children in the OIT group, and 28 (72%) of 39 children in the placebo group.","[{'ForeName': 'Paxton', 'Initials': 'P', 'LastName': 'Loke', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Department of Allergy and Immunology, Royal Children's Hospital, Parkville, VIC, Australia; Monash Children's Hospital, Clayton, VIC, Australia; Department of Paediatrics, University of Melbourne, Parkville, VIC, Australia.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Orsini', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia.""}, {'ForeName': 'Adriana C', 'Initials': 'AC', 'LastName': 'Lozinsky', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Department of Allergy and Immunology, Royal Children's Hospital, Parkville, VIC, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gold', 'Affiliation': ""Department of Paediatrics, Adelaide Medical School, University of Adelaide, Adelaide, SA, Australia; Women's and Children's Hospital Adelaide, North Adelaide, SA, Australia.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': ""O'Sullivan"", 'Affiliation': ""Immunology Department, Perth Children's Hospital, Child and Adolescent Health Service, Nedlands, WA, Australia; Discipline of Paediatrics, Medical School, The University of Western Australia, Perth, WA, Australia; Telethon Kids Institute, The University of Western Australia, Nedlands, WA, Australia.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Quinn', 'Affiliation': ""Department of Paediatrics, Adelaide Medical School, University of Adelaide, Adelaide, SA, Australia; Women's and Children's Hospital Adelaide, North Adelaide, SA, Australia.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Lloyd', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; School of Public Health and Preventative Medicine, Monash University, Melbourne, VIC, Australia.""}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Ashley', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Department of Allergy and Immunology, Royal Children's Hospital, Parkville, VIC, Australia; Department of Paediatrics, University of Melbourne, Parkville, VIC, Australia.""}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Pitkin', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Monash Children's Hospital, Clayton, VIC, Australia.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Axelrad', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia.""}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Metcalfe', 'Affiliation': ""Immunology Department, Perth Children's Hospital, Child and Adolescent Health Service, Nedlands, WA, Australia; Telethon Kids Institute, The University of Western Australia, Nedlands, WA, Australia.""}, {'ForeName': 'Ee Lyn', 'Initials': 'EL', 'LastName': 'Su', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Department of Allergy and Immunology, Royal Children's Hospital, Parkville, VIC, Australia.""}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Tey', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Department of Allergy and Immunology, Royal Children's Hospital, Parkville, VIC, Australia.""}, {'ForeName': 'Marnie N', 'Initials': 'MN', 'LastName': 'Robinson', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Department of Allergy and Immunology, Royal Children's Hospital, Parkville, VIC, Australia.""}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Allen', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Department of Paediatrics, University of Melbourne, Parkville, VIC, Australia.""}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': ""Immunology Department, Perth Children's Hospital, Child and Adolescent Health Service, Nedlands, WA, Australia; Telethon Kids Institute, The University of Western Australia, Nedlands, WA, Australia; NOVA Institute for Health, Baltimore, MD, USA; Department of Family and Community Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.""}, {'ForeName': 'Audrey Dunn', 'Initials': 'AD', 'LastName': 'Galvin', 'Affiliation': ""School of Applied Psychology, Cork University Hospital, University College Cork, Cork, Ireland; Department of Paediatrics and Paediatric Infectious Diseases, Institute of Child's Health, Sechenov First Moscow State Medical University, Moscow, Russia.""}, {'ForeName': 'Mimi L K', 'Initials': 'MLK', 'LastName': 'Tang', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Department of Allergy and Immunology, Royal Children's Hospital, Parkville, VIC, Australia; Department of Paediatrics, University of Melbourne, Parkville, VIC, Australia. Electronic address: mimi.tang@rch.org.au.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(22)00006-2']
1934,35142833,Effect of Computer-Assisted Cognitive Behavior Therapy vs Usual Care on Depression Among Adults in Primary Care: A Randomized Clinical Trial.,"Importance


Depression is a common disorder that may go untreated or receive suboptimal care in primary care settings. Computer-assisted cognitive behavior therapy (CCBT) has been proposed as a method for improving access to effective psychotherapy, reducing cost, and increasing the convenience and efficiency of treatment for depression.
Objectives


To evaluate whether clinician-supported CCBT is more effective than treatment as usual (TAU) in primary care patients with depression and to examine the feasibility and implementation of CCBT in a primary care population with substantial numbers of patients with low income, limited internet access, and low levels of educational attainment.
Design, Setting, and Participants


This randomized clinical trial included adult primary care patients from clinical practices at the University of Louisville who scored 10 or greater on the Patient Health Questionnaire-9 (PHQ-9) and were randomly assigned to CCBT or TAU for 12 weeks of active treatment. Follow-up assessments were conducted 3 and 6 months after treatment completion. Enrollment occurred from June 24, 2016, to May 13, 2019. The last follow-up assessment was conducted on January 30, 2020.
Interventions


CCBT included use of the 9-lesson computer program Good Days Ahead, along with as many as 12 weekly telephonic support sessions of approximately 20 minutes with a master's level therapist, in addition to TAU, which consisted of the standard clinical management procedures at the primary care sites. TAU was uncontrolled, but use of antidepressants and psychotherapy other than CCBT was recorded.
Main Outcomes and Measures


The primary outcome measure (PHQ-9) and secondary outcome measures (Automatic Thoughts Questionnaire for negative cognitions, Generalized Anxiety Disorder-7, and the Satisfaction with Life Scale for quality of life) were administered at baseline, 12 weeks, and 3 and 6 months after treatment completion. Satisfaction with treatment was assessed with the Client Satisfaction Questionnaire-8.
Results


The sample of 175 patients was predominately female (147 of 174 [84.5%]) and had a high proportion of individuals who identified as racial and ethnic minority groups (African American, 44 of 162 patients who reported [27.2%]; American Indian or Alaska Native, 2 [1.2%]; Hispanic, 4 [2.5%]; multiracial, 14 [8.6%]). An annual income of less than $30 000 was reported by 88 of 143 patients (61.5%). Overall, 95 patients (54.3%) were randomly assigned to CCBT and 80 (45.7%) to TAU. Dropout rates were 22.1% for CCBT (21 patients) and 30.0% for TAU (24 patients). An intent-to-treat analysis found that CCBT led to significantly greater improvement in PHQ-9 scores than TAU at posttreatment (mean difference, -2.5; 95% CI, -4.5 to -0.8; P = .005) and 3 month (mean difference, -2.3; 95% CI, -4.5 to -0.8; P = .006) and 6 month (mean difference, -3.2; 95% CI, -4.5 to -0.8; P = .007) follow-up points. Posttreatment response and remission rates were also significantly higher for CCBT (response, 58.4% [95% CI, 46.4-70.4%]; remission, 27.3% [95% CI, 16.4%-38.2%]) than TAU (response, 33.1% [95% CI, 20.7%-45.5%]; remission, 12.0% [95% CI, 3.3%- 20.7%]).
Conclusions and Relevance


In this randomized clinical trial, CCBT was found to have significantly greater effects on depressive symptoms than TAU in primary care patients with depression. Because the study population included people with lower income and lack of internet access who typically have been underrepresented or not included in earlier investigations of CCBT, results suggest that this form of treatment can be acceptable and useful in diverse primary care settings. Additional studies with larger samples are needed to address implementation procedures that could enhance the effectiveness of CCBT and to examine potential factors associated with treatment outcome.
Trial Registration


ClinicalTrials.gov Identifier: NCT02700009.",2022,"An intent-to-treat analysis found that CCBT led to significantly greater improvement in PHQ-9 scores than TAU at posttreatment (mean difference, -2.5; 95% CI, -4.5 to -0.8; P = .005) and 3 month (mean difference, -2.3; 95% CI, -4.5 to -0.8; P = .006) and 6 month (mean difference, -3.2; 95% CI, -4.5 to -0.8; P = .007) follow-up points.","['175 patients was predominately female (147 of 174 [84.5%]) and had a high proportion of individuals who identified as racial and ethnic minority groups (African American, 44 of 162 patients who reported [27.2%]; American Indian or Alaska Native, 2 [1.2%]; Hispanic, 4 [2.5%]; multiracial, 14 [8.6', 'adult primary care patients from clinical practices at the University of Louisville who scored 10 or greater on the Patient Health Questionnaire-9 (PHQ-9', 'primary care patients with depression', 'Adults in Primary Care']","['Computer-Assisted Cognitive Behavior Therapy vs Usual Care', 'Computer-assisted cognitive behavior therapy (CCBT', 'CCBT or TAU', 'CCBT', 'clinician-supported CCBT']","['Posttreatment response and remission rates', 'PHQ-9 scores', 'depressive symptoms', 'PHQ-9) and secondary outcome measures (Automatic Thoughts Questionnaire for negative cognitions, Generalized Anxiety Disorder-7, and the Satisfaction with Life Scale for quality of life', 'Dropout rates']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C5191357', 'cui_str': '27.2'}, {'cui': 'C1515945', 'cui_str': 'American Indian or Alaska native'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",175.0,0.129183,"An intent-to-treat analysis found that CCBT led to significantly greater improvement in PHQ-9 scores than TAU at posttreatment (mean difference, -2.5; 95% CI, -4.5 to -0.8; P = .005) and 3 month (mean difference, -2.3; 95% CI, -4.5 to -0.8; P = .006) and 6 month (mean difference, -3.2; 95% CI, -4.5 to -0.8; P = .007) follow-up points.","[{'ForeName': 'Jesse H', 'Initials': 'JH', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Louisville School of Medicine, Louisville, Kentucky.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Owen', 'Affiliation': 'Department of Counseling Psychology, University of Denver, Denver, Colorado.'}, {'ForeName': 'Tracy D', 'Initials': 'TD', 'LastName': 'Eells', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Louisville School of Medicine, Louisville, Kentucky.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Antle', 'Affiliation': 'Kent School of Social Work, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Bishop', 'Affiliation': 'Department of Medicine, University of Louisville School of Medicine, Louisville, Kentucky.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Girdler', 'Affiliation': 'Department of Family and Geriatric Medicine, University of Louisville School of Medicine, Louisville, Kentucky.'}, {'ForeName': 'Lesley M', 'Initials': 'LM', 'LastName': 'Harris', 'Affiliation': 'Kent School of Social Work, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'R Brent', 'Initials': 'RB', 'LastName': 'Wright', 'Affiliation': 'Department of Family and Geriatric Medicine, University of Louisville School of Medicine, Louisville, Kentucky.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Wells', 'Affiliation': 'Department of Family and Geriatric Medicine, University of Louisville School of Medicine, Louisville, Kentucky.'}, {'ForeName': 'Rangaraj', 'Initials': 'R', 'LastName': 'Gopalraj', 'Affiliation': 'Department of Family and Geriatric Medicine, University of Louisville School of Medicine, Louisville, Kentucky.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Pendleton', 'Affiliation': 'Department of Family and Geriatric Medicine, University of Louisville School of Medicine, Louisville, Kentucky.'}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Mental Health and Addictions Research Group, Department of Health Sciences, University of York, Heslington, United Kingdom.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.46716']
1935,35143273,A Multicentered Randomized Controlled Trial Comparing the Effectiveness of Pain Treatment Communication Tools in Emergency Department Patients With Back or Kidney Stone Pain.,"Objectives.  To compare the effectiveness of 3 approaches for communicating opioid risk during an emergency department visit for a common painful condition.  Methods.  This parallel, multicenter randomized controlled trial was conducted at 6 geographically disparate emergency department sites in the United States. Participants included adult patients between 18 and 70 years of age presenting with kidney stone or musculoskeletal back pain. Participants were randomly assigned to 1 of 3 risk communication strategies: (1) a personalized probabilistic risk visual aid, (2) a visual aid and a video narrative, or 3) general risk information. The primary outcomes were accuracy of risk recall, reported opioid use, and treatment preference at time of discharge.  Results.  A total of 1301 participants were enrolled between June 2017 and August 2019. There was no difference in risk recall at 14 days between the narrative and probabilistic groups (43.7% vs 38.8%; absolute risk reduction = 4.9%; 95% confidence interval [CI] = -2.98, 12.75). The narrative group had lower rates of preference for opioids at discharge than the general risk information group (25.9% vs 33.0%; difference = 7.1%; 95% CI = 0.64, 0.97). There were no differences in reported opioid use at 14 days between the narrative, probabilistic, and general risk groups (10.5%, 10.3%, and 13.3%, respectively;  P  = .44).  Conclusions.  An emergency medicine communication tool incorporating probabilistic risk and patient narratives was more effective than general information in mitigating preferences for opioids in the treatment of pain but was not more effective with respect to opioid use or risk recall.  Trial Registration.  Clinical Trials.gov identifier: NCT03134092. ( Am J Public Health . 2022;112(S1):S45-S55. https://doi.org/10.2105/AJPH.2021.306511).",2022,An emergency medicine communication tool incorporating probabilistic risk and patient narratives was more effective than general information in mitigating preferences for opioids in the treatment of pain but was not more effective with respect to opioid use or risk recall.  ,"['A total of 1301 participants were enrolled between June 2017 and August 2019', '6 geographically disparate emergency department sites in the United States', 'Emergency Department Patients With Back or Kidney Stone Pain', 'Participants included adult patients between 18 and 70 years of age presenting with kidney stone or musculoskeletal back pain']","['Pain Treatment Communication Tools', '3 risk communication strategies: (1) a personalized probabilistic risk visual aid, (2) a visual aid and a video narrative, or 3) general risk information']","['accuracy of risk recall, reported opioid use, and treatment preference at time of discharge', 'risk recall', 'rates of preference for opioids at discharge']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042813', 'cui_str': 'Visual Aids'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}]",1301.0,0.298995,An emergency medicine communication tool incorporating probabilistic risk and patient narratives was more effective than general information in mitigating preferences for opioids in the treatment of pain but was not more effective with respect to opioid use or risk recall.  ,"[{'ForeName': 'Zachary F', 'Initials': 'ZF', 'LastName': 'Meisel', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Shofer', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Dolan', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Erica B', 'Initials': 'EB', 'LastName': 'Goldberg', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Karin V', 'Initials': 'KV', 'LastName': 'Rhodes', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Hess', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Venkatesh R', 'Initials': 'VR', 'LastName': 'Bellamkonda', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Jeanmarie', 'Initials': 'J', 'LastName': 'Perrone', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Carolyn C', 'Initials': 'CC', 'LastName': 'Cannuscio', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Becker', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Rodgers', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Zyla', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Bell', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'McCollum', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Eden', 'Initials': 'E', 'LastName': 'Engel-Rebitzer', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Max Jordan Nguemeni', 'Initials': 'MJN', 'LastName': 'Tiako', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Ridgeway', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}, {'ForeName': 'Marilyn M', 'Initials': 'MM', 'LastName': 'Schapira', 'Affiliation': 'Zachary F. Meisel, Frances Shofer, Abby Dolan, Erica B. Goldberg, Melissa A. Rodgers, Michael M. Zyla, Jeffrey J. Bell, Sharon McCollum, Eden Engel-Rebitzer, and Max Jordan Nguemeni Tiako are with the Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Karin V. Rhodes is with the Agency for Healthcare Research and Quality, Bethesda, MD. Erik P. Hess is with the Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, TN. Venkatesh R. Bellamkonda is with the Department of Emergency Medicine, Mayo Clinic Alix School of Medicine, Rochester, MN. Jeanmarie Perrone is with the Center for Addiction Medicine and Policy, University of Pennsylvania. Lance Becker is with the Department of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell, New York, NY. Carolyn C. Cannuscio is with the Center for Public Health Initiatives, University of Pennsylvania. Greg Ridgeway is with the Department of Criminology, University of Pennsylvania. Marilyn M. Schapira is with the Center for Health Equity and Research Promotion, Philadelphia VA Medical Center.'}]",American journal of public health,['10.2105/AJPH.2021.306511']
1936,35144958,Improving Asthma Care Together (IMPACT) mobile health intervention for school-age children with asthma and their parents: a pilot randomised controlled trial study protocol.,"INTRODUCTION


Asthma is an incurable, lifelong condition that places children at increased risk for exacerbation, hospitalisation and school absences. Most paediatric asthma interventions target parents alone and are overly prescriptive. Improving Asthma Care Together (IMPACT) is a novel shared management system comprised of a mobile health (mHealth) application, symptom watch and tailored health intervention that pairs parent and child together as an asthma management team. IMPACT helps families monitor asthma status, tailor asthma management strategies and facilitate intentional transition of asthma management to the child. The purpose of this study is to determine the feasibility, acceptability and preliminary efficacy of the IMPACT intervention.
METHODS AND ANALYSIS


This pilot randomised controlled trial will recruit 60 children with asthma (7-11 years) and one parent. All parent-child dyads will complete data collection sessions at baseline, postintervention and follow-up. Dyads randomised to the intervention group (IMPACT) will complete the 8-week intervention comprised of weekly activities including symptom monitoring, goal setting and progress monitoring. Dyads randomised to the control group will receive usual care but then be provided access to IMPACT at the end of the study. Feasibility will be measured by the proportion of eligible dyads enrolled and retained. Acceptability of IMPACT will be assessed using the Acceptability of Intervention Measure, the System Usability Scale and a semistructured interview. Preliminary efficacy is determined based on change in primary outcomes, parent-reported and child-reported asthma responsibility and asthma self-efficacy scores, from baseline.
ETHICS AND DISSEMINATION


This study has been approved by the University of Washington Institutional Review Board; study ID: STUDY00010461. Participants gave informed consent to participate in the study before taking part. Study results will be disseminated in peer-reviewed journals and scientific conferences. A lay summary will be provided to study participants.
TRIAL REGISTRATION NUMBER


NCT04908384 (ClinicalTrials.gov identifier).",2022,"Dyads randomised to the intervention group (IMPACT) will complete the 8-week intervention comprised of weekly activities including symptom monitoring, goal setting and progress monitoring.","['school-age children with asthma and their parents', '60 children with asthma (7-11 years) and one parent']","['IMPACT) mobile health intervention', 'intervention group (IMPACT']",['asthma responsibility and asthma self-efficacy scores'],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.101395,"Dyads randomised to the intervention group (IMPACT) will complete the 8-week intervention comprised of weekly activities including symptom monitoring, goal setting and progress monitoring.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sonney', 'Affiliation': 'Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, Washington, USA jsonney@uw.edu.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Ward', 'Affiliation': 'Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, Washington, USA.'}, {'ForeName': 'Hilaire J', 'Initials': 'HJ', 'LastName': 'Thompson', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, University of Washington School of Nursing, Seattle, Washington, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Kientz', 'Affiliation': 'Human Centered Design & Engineering, University of Washington Seattle Campus, Seattle, Washington, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Segrin', 'Affiliation': 'Department of Communication, The University of Arizona, Tucson, Arizona, USA.'}]",BMJ open,['10.1136/bmjopen-2021-059791']
1937,35144954,Study protocol for a randomised trial evaluating the non-inferiority of stepped palliative care versus early integrated palliative care for patients with advanced lung cancer.,"INTRODUCTION


Integrating palliative care (PC) early in the illness course for patients with serious cancers improves their outcomes and is recommended by national organisations such as the American Society of Clinical Oncology. However, monthly visits with PC clinicians from the time of diagnosis can be challenging to implement due to the lack of specialty-trained PC clinicians and resources. Therefore, we developed a stepped care model to triage PC service based on patients' needs.
METHODS AND ANALYSIS


We are conducting a non-blinded, randomised trial to evaluate the non-inferiority of a stepped PC model compared with an early integrated PC model for improving patients' quality of life (QOL) at 24 weeks (primary outcome). Patients assigned to early integrated PC meet with PC every 4 weeks throughout their illness. Patients assigned to stepped PC have PC visits only at clinically significant points in their illness (eg, cancer progression) unless their QOL decreases, at which time they are 'stepped up' and meet with PC every 4 weeks throughout the remainder of their illness. Secondary aims include assessing whether stepped PC is non-inferior to early integrated PC regarding patient-clinician communication about end of life care and length of stay on hospice as well as comparing resource utilisation. Patients are recruited from the Massachusetts General Hospital Cancer Center, Boston, Massachusetts; Duke Cancer Center, Durham, North Carolina and University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania. The target sample size is 510 patients.
ETHICS AND DISSEMINATION


The study is funded by the National Cancer Institute, approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board and will be reported in accordance with the Consolidated Standards of Reporting Trials statement. We will disseminate results through professional society meetings, peer-reviewed publications and presentations to patient organisations.
TRIAL REGISTRATION NUMBER


NCT03337399.",2022,Secondary aims include assessing whether stepped PC is non-inferior to early integrated PC regarding patient-clinician communication about end of life care and length of stay on hospice as well as comparing resource utilisation.,"['Patients are recruited from the Massachusetts General Hospital Cancer Center, Boston, Massachusetts; Duke Cancer Center, Durham, North Carolina and University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania', '510 patients', 'patients with advanced lung cancer', 'patients with serious cancers']","['stepped palliative care versus early integrated palliative care', 'Integrating palliative care (PC']","['PC visits', ""patients' quality of life (QOL""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C1512090', 'cui_str': 'Dukes staging system'}, {'cui': 'C0454851', 'cui_str': 'Durham'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.377114,Secondary aims include assessing whether stepped PC is non-inferior to early integrated PC regarding patient-clinician communication about end of life care and length of stay on hospice as well as comparing resource utilisation.,"[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Post', 'Affiliation': 'Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA kepost@partners.org.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Heuer', 'Affiliation': 'Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Arif H', 'Initials': 'AH', 'LastName': 'Kamal', 'Affiliation': 'Medicine, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Elyze', 'Affiliation': 'Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Griffith', 'Affiliation': 'Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Friedman', 'Affiliation': 'Medicine, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Jackson', 'Affiliation': 'Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Chardria', 'Initials': 'C', 'LastName': 'Trotter', 'Affiliation': 'Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Plotke', 'Affiliation': 'Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Charu', 'Initials': 'C', 'LastName': 'Vyas', 'Affiliation': 'Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Jackson', 'Affiliation': 'Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Dustin J', 'Initials': 'DJ', 'LastName': 'Rabideau', 'Affiliation': 'Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}]",BMJ open,['10.1136/bmjopen-2021-057591']
1938,35144953,Protocol for a prospective open-label clinical trial to investigate the utility of concurrent TBS/fNIRS for antidepressant treatment optimisation.,"INTRODUCTION


Repetitive transcranial magnetic stimulation (rTMS) with theta burst stimulation (i.e. TBS) of the dorsolateral prefrontal cortex (DLPFC) is an innovative treatment for major depressive disorder (MDD). However, fewer than 50% of patients show sufficient response to this treatment; markers for response prediction are urgently needed. Research shows considerable individual variability in the brain responses to rTMS. However, whether differences in individual DLPFC modulation by rTMS can be used as a predictive marker for treatment response remains to be investigated. Here, we present a research programme that will exploit the combination of functional near-infrared spectroscopy (fNIRS) with brain stimulation. Concurrent TBS/fNIRS will allow us to systematically investigate TBS-induced modulation of blood oxygenation as a proxy for induced brain activity changes. The findings from this study will (1) elucidate the immediate effects of excitatory and inhibitory TBS on prefrontal activity in TBS treatment-naïve patients with MDD and (2) validate the potential utility of TBS-induced brain modulation at baseline for the prediction of antidepressant response to 4 weeks of daily TBS treatment.
METHODS AND ANALYSIS


Open-label, parallel-group experiment consisting of two parts. In part 1, 70 patients and 37 healthy controls will be subjected to concurrent TBS/fNIRS. Intermittent TBS (iTBS) and continuous TBS (cTBS) will be applied on the left and right DLPFC, respectively. fNIRS data will be acquired before, during and several minutes after stimulation. In part 2, patients who participated in part 1 will receive a 4 week iTBS treatment of the left DLPFC, performed daily for 5 days per week. Psychometric evaluation will be performed periodically and at 1 month treatment follow-up. Statistical analysis will include a conventional, as well as a machine learning approach.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Institutional Review Board. Findings will be disseminated through scientific journals, conferences and university courses.
TRIAL REGISTRATION NUMBER


NCT04526002.",2022,"Intermittent TBS (iTBS) and continuous TBS (cTBS) will be applied on the left and right DLPFC, respectively.","['major depressive disorder (MDD', '70 patients and 37 healthy controls', 'TBS treatment-naïve patients with MDD and (2']","['Intermittent TBS (iTBS) and continuous TBS (cTBS', 'excitatory and inhibitory TBS', 'Repetitive transcranial magnetic stimulation (rTMS) with theta burst stimulation (i.e. TBS) of the dorsolateral prefrontal cortex (DLPFC', 'rTMS']",[],"[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]",[],70.0,0.0145565,"Intermittent TBS (iTBS) and continuous TBS (cTBS) will be applied on the left and right DLPFC, respectively.","[{'ForeName': 'Rebecca L D', 'Initials': 'RLD', 'LastName': 'Kan', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Arthur D P', 'Initials': 'ADP', 'LastName': 'Mak', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sherry K W', 'Initials': 'SKW', 'LastName': 'Chan', 'Affiliation': 'Department of Psychiatry, Queen Mary Hospital, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Bella B B', 'Initials': 'BBB', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Kenneth N K', 'Initials': 'KNK', 'LastName': 'Fong', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Georg S', 'Initials': 'GS', 'LastName': 'Kranz', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China georg.kranz@polyu.edu.hk.'}]",BMJ open,['10.1136/bmjopen-2021-053896']
1939,35144952,Using provider-parent strategies to improve influenza vaccination in children and adolescents with special risk medical conditions: a randomised controlled trial protocol.,"INTRODUCTION


Influenza immunisation is a highly cost-effective public health intervention. Despite a comprehensive National Immunisation Program, influenza vaccination in children and adolescents with special risk medical conditions (SRMCs) is suboptimal. Flutext-4U is an innovative, multi-component strategy targeting paediatric hospitals, general practice and parents of children and adolescents with SRMC. The Flutext-4U study aims to assess the impact of Flutext-4U to increase influenza immunisation in children and adolescents with SRMC.
METHODS AND ANALYSIS


This is a randomised controlled trial involving parents of children and adolescents (aged >6 months to <18 years) with SRMC receiving tertiary care at the Women's and Children's Hospital (WCH), Adelaide, South Australia, who are eligible for funded influenza immunisation with a hospital appointment between the start of the seasonal influenza vaccination season and 31 July 2021, their treating general practitioners (GPs), and WCH paediatric specialists.Parents (of children/adolescents with SRMC) are randomised (1:1 ratio) to standard care plus  intervention  (SMS reminder messages to parents; reminders (written correspondence) for their child's GP from the hospital's Paediatric Outpatients Department) or  standard care  (hospital vaccine availability, ease of access and reminders for WCH subspecialists) with randomisation stratified by age-group (<5, 5-14, >14 to <18 years).The primary outcome is influenza vaccination, as confirmed by the Australian Immunisation Register.The proportion vaccinated (primary outcome) will be compared between randomised groups using logistic regression, with adjustment made for age group at randomisation. The effect of treatment will be described using an OR with a 95% CI.
ETHICS AND DISSEMINATION


The protocol and all study materials have been reviewed and approved by the Women's and Children's Health Network Human Research Ethics Committee (HREC/20/WCHN/5). Results will be disseminated via peer-reviewed publication and at scientific meetings, professional and public forums.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12621000463875).",2022,"The Flutext-4U study aims to assess the impact of Flutext-4U to increase influenza immunisation in children and adolescents with SRMC.
","['paediatric hospitals, general practice and parents of children and adolescents with SRMC', 'Parents (of children/adolescents with SRMC', ""parents of children and adolescents (aged >6 months to <18 years) with SRMC receiving tertiary care at the Women's and Children's Hospital (WCH), Adelaide, South Australia, who are eligible for funded influenza immunisation with a hospital appointment between the start of the seasonal influenza vaccination season and 31 July 2021, their treating general practitioners (GPs), and WCH paediatric specialists"", 'children and adolescents with special risk medical conditions', 'children and adolescents with SRMC', 'children and adolescents with special risk medical conditions (SRMCs']","['Flutext-4U', ""standard care plus  intervention  (SMS reminder messages to parents; reminders (written correspondence) for their child's GP from the hospital's Paediatric Outpatients Department) or  standard care  (hospital vaccine availability, ease of access and reminders for WCH subspecialists"", 'provider-parent strategies to improve influenza vaccination']",[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}]",[],,0.292204,"The Flutext-4U study aims to assess the impact of Flutext-4U to increase influenza immunisation in children and adolescents with SRMC.
","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Tuckerman', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia jane.tuckerman@mcri.edu.au.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Harper', 'Affiliation': ""Women's and Children's Health Network, North Adelaide, South Australia, Australia.""}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Sullivan', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fereday', 'Affiliation': ""Women's and Children's Health Network, North Adelaide, South Australia, Australia.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Couper', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Smith', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Tai', 'Affiliation': ""Women's and Children's Health Network, North Adelaide, South Australia, Australia.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kelly', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Couper', 'Affiliation': ""Women's and Children's Health Network, North Adelaide, South Australia, Australia.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Friswell', 'Affiliation': ""Women's and Children's Health Network, North Adelaide, South Australia, Australia.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Flood', 'Affiliation': 'Communicable Disease Control Branch, South Australian Department of Health and Wellbeing, Adelaide, South Australia, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Danchin', 'Affiliation': ""Vaccine Uptake Group, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Blyth', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, University Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Marshall', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2021-053838']
1940,35146776,A dose-escalation clinical trial of intranasal ketamine for uncontrolled cancer-related pain.,"STUDY OBJECTIVE


The objective of our study was to determine safety and pharmacology (pharmacokinetics and preliminary efficacy) of intranasal (IN) ketamine for uncontrolled cancer-related pain.
DESIGN


Dose escalation clinical trial.
SETTING


Outpatient.
PATIENTS


Ten adult patients with uncontrolled cancer-related pain.
INTERVENTION


Each patient received escalating doses of ketamine over four visits, each 2-5 days apart: 10 mg IN at visit 1, 10 mg intravenous (IV) at visit 2, 30 mg IN at visit 3, and 50 mg IN at visit 4.
MEASUREMENTS


Pain was measured before and after drug administration for up to 4 h using the 11 point (0-10) Numerical Pain Rating Scale (NPRS).
MAIN RESULTS


All subjects had advanced cancer, with intractable pain, despite being on moderate dosage of opioids. There was a statistically significant reduction in median NPRS by 1.5 (1-4), 3 (2-3), and 4 (3-5) points at 60 min after receiving the medication and remained decreased by 1.5 (1-2), 2 (1-2) and 1 (1-4) points at the end of the study visit (240 min) with the 10 mg, 30 mg and 50 mg IN dosage, respectively. The median percentage of maximal pain relief being 22.5 (16.6-71.5), 65.5 (40-100), and 69.25 (50-100) for 10 mg, 30 mg and 50 mg IN dosage, respectively and 100 (75-100) with 10 mg IV dose. All side effects (nausea and feeling of unreality) resolved by the end of each study visit. No severe adverse events occurred.
CONCLUSION


In this single-institution study, all dosages of IN ketamine administered in the study (10, 30, and 50 mg) provided significant pain relief for intractable cancer-related pain and were well tolerated. The 50 mg dose provided maximal pain relief without major side effects. Further study focused on repeated administration efficacy and safety for cancer-related pain is warranted.",2022,"No severe adverse events occurred.
","['All patients had advanced cancer, with intractable pain, despite being on moderate dosage of opioids', '10 adult patients with uncontrolled cancer-related pain', 'uncontrolled cancer-related pain']","['ketamine', 'intranasal ketamine', 'Intranasal (IN) ketamine']","['median (interquartile range, p value) NPRS', 'Pain', 'pain relief for intractable cancer-related pain and were well tolerated', 'severe adverse events', 'efficacy and safety', 'maximal pain relief', 'safety and pharmacology (pharmacokinetics and preliminary efficacy', 'Numerical Pain Rating Scale (NPRS', 'All side effects (nausea and feeling of unreality']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030200', 'cui_str': 'Refractory Pain'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0233754', 'cui_str': 'Derealization'}]",10.0,0.461466,"No severe adverse events occurred.
","[{'ForeName': 'Vinita', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Department of Anesthesiology, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Theresa W', 'Initials': 'TW', 'LastName': 'Gillespie', 'Affiliation': 'Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Olabisi', 'Initials': 'O', 'LastName': 'Lane', 'Affiliation': 'Department of Anesthesiology, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Spektor', 'Affiliation': 'Department of Anesthesiology, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Ali John', 'Initials': 'AJ', 'LastName': 'Zarrabi', 'Affiliation': 'Department of Family Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Egan', 'Affiliation': 'Department of Anesthesiology, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Curseen', 'Affiliation': 'Department of Family Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Tsvetkova', 'Affiliation': 'Cancer Therapeutics Program, UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Beumer', 'Affiliation': 'Cancer Therapeutics Program, UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Sniecinski', 'Affiliation': 'Department of Anesthesiology, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Jack W', 'Initials': 'JW', 'LastName': 'Shteamer', 'Affiliation': 'Department of Anesthesiology, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Switchenko', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'R Donald', 'Initials': 'RD', 'LastName': 'Harvey', 'Affiliation': 'Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",Pharmacotherapy,['10.1002/phar.2669']
1941,35134673,A predictive model with a risk-classification system for cancer-specific survival in patients with primary osteosarcoma of long bone.,"BACKGROUND


Osteosarcoma (OS), most commonly occurring in long bone, is a group of malignant tumors with high incidence in adolescents. No individualized model has been developed to predict the prognosis of primary long bone osteosarcoma (PLBOS) and the current AJCC TNM staging system lacks accuracy in prognosis prediction. We aimed to develop a nomogram based on the clinicopathological factors affecting the prognosis of PLBOS patients to help clinicians predict the cancer-specific survival (CSS) of PLBOS patients.
METHOD


We studied 1199 PLBOS patients from the Surveillance, Epidemiology, and End Results (SEER) database from 2004 to 2015 and randomly divided the dataset into training and validation cohorts at a proportion of 7:3. Independent prognostic factors determined by stepwise multivariate Cox analysis were included in the nomogram and risk-stratification system. C-index, calibration curve, and decision curve analysis (DCA) were used to verify the performance of the nomogram.
RESULTS


Age, Histological type, Surgery of primary site, Tumor size, Local extension, Regional lymph node (LN) invasion, and Distant metastasis were identified as independent prognostic factors. C-indexes, calibration curves and DCAs of the nomogram indicating that the nomogram had good discrimination and validity. The risk-stratification system based on the nomogram showed significant differences (P < 0.05) in CSS among different risk groups.
CONCLUSION


We established a nomogram with risk-stratification system to predict CSS in PLBOS patients and demonstrated that the nomogram had good performance. This model can help clinicians evaluate prognoses, identify high-risk individuals, and give individualized treatment recommendation of PLBOS patients.",2022,"The risk-stratification system based on the nomogram showed significant differences (P < 0.05) in CSS among different risk groups.
","['malignant tumors with high incidence in adolescents', 'patients with primary osteosarcoma of long bone', '1199 PLBOS patients from the Surveillance, Epidemiology, and End Results (SEER) database from 2004 to 2015 and randomly divided the dataset into training and validation cohorts at a proportion of 7:3']",[],"['cancer-specific survival (CSS', 'C-index, calibration curve, and decision curve analysis (DCA']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4543929', 'cui_str': 'Primary osteosarcoma'}, {'cui': 'C0222647', 'cui_str': 'Structure of long bone'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",1199.0,0.0557085,"The risk-stratification system based on the nomogram showed significant differences (P < 0.05) in CSS among different risk groups.
","[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': 'Department of Orthopaedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopaedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.'}, {'ForeName': 'Xiangcheng', 'Initials': 'X', 'LastName': 'Qing', 'Affiliation': 'Department of Orthopaedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopaedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.'}, {'ForeName': 'Yizhong', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Orthopaedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China. Electronic address: pyz5941z@163.com.'}, {'ForeName': 'Baichuan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China. Electronic address: wangbaichuan-112@163.com.'}, {'ForeName': 'Zengwu', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'Department of Orthopaedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China. Electronic address: szwpro@163.com.'}]",Translational oncology,['10.1016/j.tranon.2022.101349']
1942,35134661,Effect of remote ischemic preconditioning on cerebral oxygen saturation in aneurysmal subarachnoid hemorrhage: Secondary analysis of a randomized controlled trial.,"Remote ischemic preconditioning (RIPC) can ameliorate cerebral vasospasm and delayed cerebral ischemia and improve neurological outcomes in patients with aneurysmal subarachnoid hemorrhage (aSAH). Monitoring of regional cerebral oxygen saturation (rScO2) during the critical phase after aSAH can help detect ischemia and assess the effect of RIPC intervention. We investigated the effect of RIPC on rScO2 in patients with aSAH. Our study was a single-center, prospective, parallel-group, randomized pilot trial. After approval by institutional ethics committee, consenting patients (n = 25) with aSAH presenting within 72 h of ictus and scheduled for surgical clipping of cerebral aneurysm were randomized 1:1 to true RIPC (inflation of upper extremity blood pressure cuff thrice to 30 mmHg above systolic blood pressure for 5 min) or sham RIPC (inflation of blood pressure cuff thrice to 30 mmHg for 5 min). In this secondary analysis, our outcome measures assessed by a blinded observer were incidence of cerebral oxygen desaturation (COD) during 7-10 days after ictus and Glasgow outcome scale extended (GOSE) at discharge. The incidence of COD (decrease in rScO2 > 20% from baseline) was lower in the RIPC group (15.4% versus 33.3%); p = 0.378. The absence of ipsilateral COD resulted in a higher mean GOSE (estimate 1.15, p = 0.015). The RIPC group had a higher mean GOSE compared to sham group (estimate 0.8, p = 0.027). This pilot trial demonstrated that RIPC has the potential to prevent COD in patients with aSAH. Larger trials with cerebral oxygenation as the primary outcome are needed to confirm our findings.",2022,"The absence of ipsilateral COD resulted in a higher mean GOSE (estimate 1.15, p = 0.015).","['aneurysmal subarachnoid hemorrhage', 'consenting patients (n\xa0=\xa025) with aSAH presenting within 72\xa0h of ictus and scheduled for surgical clipping of cerebral aneurysm', 'patients with aneurysmal subarachnoid hemorrhage (aSAH', 'patients with aSAH']","['Remote ischemic preconditioning (RIPC', 'remote ischemic preconditioning', 'regional cerebral oxygen saturation (rScO2', 'RIPC', 'true RIPC (inflation of upper extremity blood pressure cuff thrice to 30\xa0mmHg above systolic blood pressure for 5\xa0min) or sham RIPC (inflation of blood pressure cuff thrice to 30\xa0mmHg for 5\xa0min']","['incidence of cerebral oxygen desaturation (COD', 'mean GOSE', 'cerebral vasospasm and delayed cerebral ischemia', 'neurological outcomes', 'incidence of COD', 'cerebral oxygen saturation']","[{'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0155730', 'cui_str': 'Cerebral aneurysm, nonruptured'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0265110', 'cui_str': 'Spasm of cerebral arteries'}, {'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}]",,0.270282,"The absence of ipsilateral COD resulted in a higher mean GOSE (estimate 1.15, p = 0.015).","[{'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Sangeetha', 'Affiliation': 'Department of Neuroanesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bengaluru 560029, India. Electronic address: sangeetharp@nimhans.ac.in.'}, {'ForeName': 'V J', 'Initials': 'VJ', 'LastName': 'Ramesh', 'Affiliation': 'Department of Neuroanesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bengaluru 560029, India.'}, {'ForeName': 'Sriganesh', 'Initials': 'S', 'LastName': 'Kamath', 'Affiliation': 'Department of Neuroanesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bengaluru 560029, India.'}, {'ForeName': 'Dhritiman', 'Initials': 'D', 'LastName': 'Chakrabarti', 'Affiliation': 'Department of Neuroanesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bengaluru 560029, India.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Christopher', 'Affiliation': 'Department of Neurochemistry, National Institute of Mental Health and Neurosciences, Bengaluru 560029, India.'}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Aravinda', 'Affiliation': 'Department of Neuroimaging and Interventional Radiology, National Institute of Mental Health and Neurosciences, Bengaluru 560029, India.'}, {'ForeName': 'Dhananjaya I', 'Initials': 'DI', 'LastName': 'Bhat', 'Affiliation': 'Department of Neurosurgery, Aster RV Hospital, Bengaluru 560078, India.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2022.01.035']
1943,35139082,Information nudges for influenza vaccination: Evidence from a large-scale cluster-randomized controlled trial in Finland.,"BACKGROUND


Vaccination is the most effective means of preventing the spread of infectious diseases. Despite the proven benefits of vaccination, vaccine hesitancy keeps many people from getting vaccinated.
METHODS AND FINDINGS


We conducted a large-scale cluster randomized controlled trial in Finland to test the effectiveness of centralized written reminders (distributed via mail) on influenza vaccination coverage. The study included the entire older adult population (aged 65 years and above) in 2 culturally and geographically distinct regions with historically low (31.8%, n = 7,398, mean age 75.5 years) and high (57.7%, n = 40,727, mean age 74.0 years) influenza vaccination coverage. The study population was randomized into 3 treatments: (i) no reminder (only in the region with low vaccination coverage); (ii) an individual-benefits reminder, informing recipients about the individual benefits of vaccination; and (iii) an individual- and social-benefits reminder, informing recipients about the additional social benefits of vaccination in the form of herd immunity. There was no control treatment group in the region with high vaccination coverage as general reminders had been sent in previous years. The primary endpoint was a record of influenza vaccination in the Finnish National Vaccination Register during a 5-month follow-up period (from October 18, 2018 to March 18, 2019). Vaccination coverage after the intervention in the region with historically low coverage was 41.8% in the individual-benefits treatment, 38.9% in the individual- and social-benefits treatment and 34.0% in the control treatment group. Vaccination coverage after the intervention in the region with historically high coverage was 59.0% in the individual-benefits treatment and 59.2% in the individual- and social-benefits treatment. The effect of receiving any type of reminder letter in comparison to control treatment group (no reminder) was 6.4 percentage points (95% CI: 3.6 to 9.1, p < 0.001). The effect of reminders was particularly large among individuals with no prior influenza vaccination (8.8 pp, 95% CI: 6.5 to 11.1, p < 0.001). There was a substantial positive effect (5.3 pp, 95% CI: 2.8 to 7.8, p < 0.001) among the most consistently unvaccinated individuals who had not received any type of vaccine during the 9 years prior to the study. There was no difference in influenza vaccination coverage between the individual-benefit reminder and the individual- and social-benefit reminder (region with low vaccination coverage: 2.9 pp, 95% CI: -0.4 to 6.1, p = 0.087, region with high vaccination coverage: 0.2 pp, 95% CI: -1.0 to 1.3, p = 0.724). Study limitations included potential contamination between the treatments due to information spillovers and the lack of control treatment group in the region with high vaccination coverage.
CONCLUSIONS


In this study, we found that sending reminders was an effective and scalable intervention strategy to increase vaccination coverage in an older adult population with low vaccination coverage. Communicating the social benefits of vaccinations, in addition to individual benefits, did not enhance vaccination coverage. The effectiveness of letter reminders about the benefits of vaccination to improve influenza vaccination coverage may depend on the prior vaccination history of the population.
TRIAL REGISTRATION


AEA RCT registry AEARCTR-0003520 and ClinicalTrials.gov NCT03748160.",2022,"There was no difference in influenza vaccination coverage between the individual-benefit reminder and the individual- and social-benefit reminder (region with low vaccination coverage: 2.9 pp, 95% CI: -0.4 to 6.1, p = 0.087, region with high vaccination coverage: 0.2 pp, 95% CI: -1.0 to 1.3, p = 0.724).","['older adult population with low vaccination coverage', 'entire older adult population (aged 65 years and above) in 2 culturally and geographically distinct regions with historically low (31.8%, n = 7,398, mean age 75.5 years) and high (57.7%, n = 40,727, mean age 74.0 years) influenza vaccination coverage']",['centralized written reminders (distributed via mail'],"['influenza vaccination in the Finnish National Vaccination Register', 'Vaccination coverage', 'substantial positive effect', 'influenza vaccination coverage']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4505148', 'cui_str': 'Vaccination Coverage'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0024492', 'cui_str': 'Mail'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4505148', 'cui_str': 'Vaccination Coverage'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",40727.0,0.213471,"There was no difference in influenza vaccination coverage between the individual-benefit reminder and the individual- and social-benefit reminder (region with low vaccination coverage: 2.9 pp, 95% CI: -0.4 to 6.1, p = 0.087, region with high vaccination coverage: 0.2 pp, 95% CI: -1.0 to 1.3, p = 0.724).","[{'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Sääksvuori', 'Affiliation': 'Tampere University, Department of Health Sciences, Faculty of Social Sciences, Tampere, Finland.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Betsch', 'Affiliation': 'University of Erfurt, Media and Communication Science and Center for Empirical Research in Economics and Behavioral Sciences, Erfurt, Germany.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Nohynek', 'Affiliation': 'Finnish Institute for Health and Welfare, Infectious Disease Control and Vaccinations, Department of Health Security, Helsinki, Finland.'}, {'ForeName': 'Heini', 'Initials': 'H', 'LastName': 'Salo', 'Affiliation': 'Finnish Institute for Health and Welfare, Infectious Disease Control and Vaccinations, Department of Health Security, Helsinki, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Sivelä', 'Affiliation': 'Finnish Institute for Health and Welfare, Infectious Disease Control and Vaccinations, Department of Health Security, Helsinki, Finland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Böhm', 'Affiliation': 'University of Vienna, Faculty of Psychology, Vienna, Austria.'}]",PLoS medicine,['10.1371/journal.pmed.1003919']
1944,35139070,"Safety and efficacy of mass drug administration with a single-dose triple-drug regimen of albendazole + diethylcarbamazine + ivermectin for lymphatic filariasis in Papua New Guinea: An open-label, cluster-randomised trial.","BACKGROUND


Papua New Guinea (PNG) has a high burden of lymphatic filariasis (LF) caused by Wuchereria bancrofti, with an estimated 4.2 million people at risk of infection. A single co-administered dose of ivermectin, diethylcarbamazine and albendazole (IDA) has been shown to have superior efficacy in sustained clearance of microfilariae compared to diethylcarbamazine and albendazole (DA) in small clinical trials. A community-based cluster-randomised trial of DA versus IDA was conducted to compare the safety and efficacy of IDA and DA for LF in a moderately endemic, treatment-naive area in PNG.
METHODOLOGY


All consenting, eligible residents of 24 villages in Bogia district, Madang Province, PNG were enrolled, screened for W. bancrofti antigenemia and microfilaria (Mf) and randomised to receive IDA (N = 2382) or DA (N = 2181) according to their village of residence. Adverse events (AE) were assessed by active follow-up for 2 days and passive follow-up for an additional 5 days. Antigen-positive participants were re-tested one year after MDA to assess treatment efficacy.
PRINCIPAL FINDINGS


Of the 4,563 participants enrolled, 96% were assessed for AEs within 2 days after treatment. The overall frequency of AEs were similar after either DA (18%) or IDA (20%) treatment. For those individuals with AEs, 87% were mild (Grade 1), 13% were moderate (Grade 2) and there were no Grade 3, Grade 4, or serious AEs (SAEs). The frequency of AEs was greater in Mf-positive than Mf-negative individuals receiving IDA (39% vs 20% p<0.001) and in Mf-positive participants treated with IDA (39%), compared to those treated with DA (24%, p = 0.023). One year after treatment, 64% (645/1013) of participants who were antigen-positive at baseline were re-screened and 74% of these participants (475/645) remained antigen positive. Clearance of Mf was achieved in 96% (52/54) of infected individuals in the IDA arm versus 84% (56/67) of infected individuals in the DA arm (relative risk (RR) 1.15; 95% CI, 1.02 to 1.30; p = 0.019). Participants receiving DA treatment had a 4-fold higher likelihood of failing to clear Mf (RR 4.67 (95% CI: 1.05 to 20.67; p = 0.043). In the DA arm, a significant predictor of failure to clear was baseline Mf density (RR 1.54; 95% CI, 1.09 to 2.88; p = 0.007).
CONCLUSION


IDA was well tolerated and more effective than DA for clearing Mf. Widespread use of this regimen could accelerate LF elimination in PNG.
TRIAL REGISTRATION


Registration number NCT02899936; https://clinicaltrials.gov/ct2/show/NCT02899936.",2022,"Clearance of Mf was achieved in 97% (52/54) of infected individuals in the IDA arm versus 84% (56/67) of infected individuals in the DA arm (relative risk (RR) 1.15; 95% CI, 1.02 to 1.30; p = 0.019).","['Madang Province, PNG were enrolled, screened for W. bancrofti antigenemia and microfilaria (Mf) and randomised to receive IDA (N = 2382) or DA (N = 2181) according to their village of residence', 'Of the 4,563 participants enrolled, 96% were assessed for AEs within 2 days after treatment', 'All consenting, eligible residents of 24 villages in Bogia district', 'lymphatic filariasis in Papua New Guinea', 'Papua New Guinea (PNG']","['albendazole + diethylcarbamazine + ivermectin', 'diethylcarbamazine and albendazole (DA', 'ivermectin, diethylcarbamazine and albendazole (IDA', 'DA versus IDA', 'IDA']","['baseline Mf density', 'frequency of AEs', 'Adverse events (AE', 'Clearance of Mf', 'overall frequency of AEs', 'safety and efficacy of IDA and DA', 'Safety and efficacy', 'likelihood of failing to clear Mf']","[{'cui': 'C0030375', 'cui_str': 'Papua New Guinea'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025980', 'cui_str': 'Superfamily Filarioidea microfilaria'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0012191', 'cui_str': 'Diethylcarbamazine'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0013884', 'cui_str': 'Lymphatic filariasis'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0012191', 'cui_str': 'Diethylcarbamazine'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025980', 'cui_str': 'Superfamily Filarioidea microfilaria'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0012191', 'cui_str': 'Diethylcarbamazine'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}]",4563.0,0.484378,"Clearance of Mf was achieved in 97% (52/54) of infected individuals in the IDA arm versus 84% (56/67) of infected individuals in the DA arm (relative risk (RR) 1.15; 95% CI, 1.02 to 1.30; p = 0.019).","[{'ForeName': 'Livingstone', 'Initials': 'L', 'LastName': 'Tavul', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Laman', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea.'}, {'ForeName': 'Cade', 'Initials': 'C', 'LastName': 'Howard', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Bethuel', 'Initials': 'B', 'LastName': 'Kotty', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Samuel', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bjerum', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Kobie', 'Initials': 'K', 'LastName': ""O'Brian"", 'Affiliation': 'Infectious Diseases Division, Department of Medicine, Washington University School of Medicine in St. Louis, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kumai', 'Affiliation': 'Bogia District Health Authority, Bogia, Papua New Guinea.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Amuga', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Lorry', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea.'}, {'ForeName': 'Zebedee', 'Initials': 'Z', 'LastName': 'Kerry', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Kualawi', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Karl', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Makita', 'Affiliation': 'National Department of Health, Waigani, Papua New Guinea.'}, {'ForeName': 'Lucy N', 'Initials': 'LN', 'LastName': 'John', 'Affiliation': 'National Department of Health, Waigani, Papua New Guinea.'}, {'ForeName': 'Sibauk', 'Initials': 'S', 'LastName': 'Bieb', 'Affiliation': 'National Department of Health, Waigani, Papua New Guinea.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wangi', 'Affiliation': 'WHO Papua New Guinea, NTD Program, Waigani, Papua New Guinea.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Weil', 'Affiliation': 'Infectious Diseases Division, Department of Medicine, Washington University School of Medicine in St. Louis, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Goss', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tisch', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio, United States of America.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Pomat', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'King', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Leanne J', 'Initials': 'LJ', 'LastName': 'Robinson', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0010096']
1945,35140309,Oropharyngeal administration of mother's own milk influences levels of salivary sIgA in preterm infants fed by gastric tube.,"The aim of the present study was to explore the effect of oropharyngeal mother's milk administration on salivary secretory immunoglobulin A (sIgA) levels in preterm infants fed by gastric tube. Infants (n = 130) with birth weight < 1500 g were randomly allocated into two groups which both received breast milk for enteral nutrition. The experimental group (n = 65) accepted oropharyngeal mother's milk administration before gastric tube feeding for 14 days after birth. The control group (n = 65) accepted oropharyngeal 0.9% normal saline administration. Saliva concentration of sIgA were assessed at the 2 h, 7th and 14th day after birth. The level of salivary sIgA in experimental group were significantly higher than those in control group on the 7th day after birth (p < 0.05), but there were no differences in salivary sIgA levels on the 14th day between the two groups. The results of quantile regression analysis showed that oropharyngeal mother's milk administration, delivery mode and gestational age had significant effects on the increase of sIgA. SIgA in experimental group and the total number of intervention had a significant positive correlation (p < 0.05). Oropharyngeal mother's milk administration can improve salivary sIgA levels of preterm infants.",2022,"The level of salivary sIgA in experimental group were significantly higher than those in control group on the 7th day after birth (p < 0.05), but there were no differences in salivary sIgA levels on the 14th day between the two groups.","['\u20091500\xa0g', 'preterm infants fed by gastric tube', 'preterm infants', 'Infants (n\u2009=\u2009130) with birth weight']","['oropharyngeal 0.9% normal saline administration', ""oropharyngeal mother's milk administration"", ""oropharyngeal mother's milk administration before gastric tube feeding"", 'breast milk for enteral nutrition']","['sIgA. SIgA', 'Saliva concentration of sIgA', 'level of salivary sIgA', 'salivary sIgA levels', 'salivary secretory immunoglobulin A (sIgA) levels']","[{'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]","[{'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439166', 'cui_str': '% normal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0086337', 'cui_str': 'Gastric Feeding Tubes'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",,0.0508696,"The level of salivary sIgA in experimental group were significantly higher than those in control group on the 7th day after birth (p < 0.05), but there were no differences in salivary sIgA levels on the 14th day between the two groups.","[{'ForeName': 'Li-Lian', 'Initials': 'LL', 'LastName': 'Chen', 'Affiliation': 'Department of Neonatology, Affiliated Shenzhen Maternity & Child Healthcare Hospital, Southern Medical University, Shenzhen, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Shanxi University of Chinese Medicine, Shanxi, China.'}, {'ForeName': 'Xiao-He', 'Initials': 'XH', 'LastName': 'Mu', 'Affiliation': 'Shanxi University of Chinese Medicine, Shanxi, China.'}, {'ForeName': 'Xi-Yang', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Shanxi University of Chinese Medicine, Shanxi, China.'}, {'ForeName': 'Chuan-Zhong', 'Initials': 'CZ', 'LastName': 'Yang', 'Affiliation': 'Department of Neonatology, Affiliated Shenzhen Maternity & Child Healthcare Hospital, Southern Medical University, Shenzhen, China. yangczgd@smu.edu.cn.'}, {'ForeName': 'Xiao-Yun', 'Initials': 'XY', 'LastName': 'Xiong', 'Affiliation': 'Department of Neonatology, Affiliated Shenzhen Maternity & Child Healthcare Hospital, Southern Medical University, Shenzhen, China.'}, {'ForeName': 'Mei-Qi', 'Initials': 'MQ', 'LastName': 'Wang', 'Affiliation': 'Department of Neonatology, Affiliated Shenzhen Maternity & Child Healthcare Hospital, Southern Medical University, Shenzhen, China.'}]",Scientific reports,['10.1038/s41598-022-06243-2']
1946,35144164,Immediate knowledge retention among nursing students in live lecture and video-recorded lecture: A quasi-experimental study.,"AIM/OBJECTIVE


To determine if video-recorded lecture provided better immediate knowledge retention than live lecture BACKGROUND: In line with the call to increase nationally graduated nurses as recommended by KSU 2030 Vision, educational institutions in Saudi Arabia are required to increase the enrollment to the Bachelor of Science in Nursing program. As a result, there is increased number of sections or groupings which created a need for additional faculty. However, to mitigate the impact of faculty shortage, the Administration embarked on exploring innovative teaching strategies that would ensure that lecture contents across groups of students are uniform and instructions are similar. Hence there is a need to explore innovative teaching strategies that would ensure that contents across groups of students are uniform, and instructions are similar.
DESIGN


The study employed a quasi-experimental design to examine if video-recorded lectures provided better immediate knowledge retention than live lectures.
METHODS


A total of 160 s -year nursing students were randomly assigned to either of the two teaching strategies (video-recorded lecture or live lecture). Data were collected at a public university in Riyadh, Saudi Arabia. Both lectures covered the interpretation of arterial blood gases (ABG) and all students had no prior knowledge on the subject. Pretest and posttest using the same 16 questions were administered to both groups. Each item was comprised of a combination of ABG results. Students were to choose the correct answer from four choices of interpretations of the ABG result. ABG is assessed to determine gas exchange, ventilator control and acid-base balance among patients with acute or chronic illnesses. Assessment of immediate knowledge retention was conducted using a questionnaire comprised of 16 multiple-choice items to be used in both the pretest and posttest. Each item was comprised of a combination of ABG results.
RESULTS


The live lecture group's posttest mean score did not differ significantly from that of the video-recorded lecture group; t (156.52) = 0.47, p = 0.64, d = -0.08. The odds ratio is 1.27 and the probability is 95%. CI:.64, 2.50.
CONCLUSION


This study found no difference between video-recorded lectures and live lectures in terms of providing immediate knowledge retention. Video-recorded lectures are a viable complementary teaching strategy. There is a need to enhance the instructional design so that learning objectives are more clearly defined, contents are aligned with the learning objectives, teaching strategies should include active participation from learners and outcomes should be assessed based on the learning objectives.",2022,The live lecture group's posttest mean score did not differ significantly from that of the video-recorded lecture group; t (156.52) = ,"['nursing students in live lecture and video-recorded lecture', 'Data were collected at a public university in Riyadh, Saudi Arabia', 'A total of 160', 'patients with acute or chronic illnesses', 'nursing students']","['video-recorded lecture', 'two teaching strategies (video-recorded lecture or live lecture']",['arterial blood gases (ABG'],"[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}]",,0.0407542,The live lecture group's posttest mean score did not differ significantly from that of the video-recorded lecture group; t (156.52) = ,"[{'ForeName': 'Homood A', 'Initials': 'HA', 'LastName': 'Alharbi', 'Affiliation': 'College of Nursing, King Saud University, Riyadh, Saudi Arabia. Electronic address: homalharbi@ksu.edu.sa.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Shehadeh', 'Affiliation': 'King Fahad Medical City, Riyadh, Saudi Arabia. Electronic address: fshehadeh@kfmc.med.sa.'}, {'ForeName': 'Nasima Yahya', 'Initials': 'NY', 'LastName': 'Awaji', 'Affiliation': 'Medical Surgical Department, Nursing College, KSU, Saudi Arabia. Electronic address: nawaji@KSU.EDU.SA.'}]",Nurse education in practice,['10.1016/j.nepr.2022.103307']
1947,35144024,"Cost Effectiveness of Mailed Outreach Programs for Colorectal Cancer Screening: Analysis of a Pragmatic, Randomized Trial.","BACKGROUND & AIMS


Clinical guidelines for colorectal cancer (CRC) screening suggest use of either stool-based tests or colonoscopy - modalities that differ in recommended screening intervals, adherence, and costs. We know little about the long-term cost differences in population-health outreach strategies to promote these strategies.
METHODS


We conducted a cost-effectiveness analysis to compare 2 mailed outreach strategies to increase CRC screening from a pragmatic, randomized clinical trial: mailed fecal immunochemical test (FIT) kits vs invitations to complete a screening colonoscopy. We built a 10-year Markov chain Monte Carlo microsimulation model to account for differences in screening intervals, adherence, and costs.
RESULTS


Mailed FIT kits had a lower 10-year average per-person costs of screening than colonoscopy invitations ($1139 vs $1725) but with 10.89 fewer months of compliance and 60 fewer advanced neoplasia detected (37 advanced adenomas and 23 CRC). Incremental cost effectiveness ratios for colonoscopy invitations compared with mailed FIT kits were $55.23, $15.84, and $25.48 per additional covered month, advanced adenoma, and CRC, respectively. Although FIT was the preferred strategy at low willingness-to-pay thresholds, the 2 strategies were equal at a willingness-to-pay threshold of $41.31 per covered month gained.
CONCLUSION


Mailed FIT or colonoscopy invitations are both options to improve CRC screening completion and advanced neoplasia detection, and the choice of outreach strategy may differ by a health system's willingness to pay threshold. Mailed FIT kits are less expensive than colonoscopy invitations but result in fewer months of screening compliance and advanced neoplasia detected.",2022,"Incremental cost effectiveness ratios (ICER) for colonoscopy invitations compared to mailed FIT kits were $55.23, $15.84, and $25.48 per additional covered month, advanced adenoma, and CRC.",['colorectal cancer screening'],['mailed outreach programs'],"['Incremental cost effectiveness ratios (ICER', '10-year average per-person costs of screening', 'Cost effectiveness', 'screening intervals, adherence, and costs']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0698282,"Incremental cost effectiveness ratios (ICER) for colonoscopy invitations compared to mailed FIT kits were $55.23, $15.84, and $25.48 per additional covered month, advanced adenoma, and CRC.","[{'ForeName': 'Kandice A', 'Initials': 'KA', 'LastName': 'Kapinos', 'Affiliation': 'Departments of Population and Data Sciences and Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas; Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas; RAND Corporation, Arlington, Virginia. Electronic address: kandice.kapinos@utsouthwestern.edu.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Halm', 'Affiliation': 'Departments of Population and Data Sciences and Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas; Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas.'}, {'ForeName': 'Caitlin C', 'Initials': 'CC', 'LastName': 'Murphy', 'Affiliation': 'Departments of Population and Data Sciences and Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas; School of Public Health, University of Texas Health Science Center at Houston (UTHealth), Houston, Texas.'}, {'ForeName': 'Noel O', 'Initials': 'NO', 'LastName': 'Santini', 'Affiliation': 'Parkland Health and Hospital System, Dallas, Texas.'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Loewen', 'Affiliation': 'Departments of Population and Data Sciences and Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Celette Sugg', 'Initials': 'CS', 'LastName': 'Skinner', 'Affiliation': 'Departments of Population and Data Sciences and Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas; Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas.'}, {'ForeName': 'Amit G', 'Initials': 'AG', 'LastName': 'Singal', 'Affiliation': 'Departments of Population and Data Sciences and Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas; Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2022.01.054']
1948,35144699,"Fish oil supplementation may improve attention, working memory and attention-deficit/hyperactivity disorder symptoms in adults with autism spectrum disorder: a randomised crossover trial.","Marine n-3 fatty acids (n-3LCPUFA) have shown neurocognitive benefits in children with attention-deficit/hyperactivity disorder (ADHD), but few trials have examined effects in adults with autism spectrum disorder (ASD). We explored, if n-3LCPUFA affect cognitive functions in adults with ASD, and if effects are modified by comorbid ADHD. In a 2 × 4 week crossover study, twenty-six participants were randomised to sequence of supplementation with fish oil (FO, 5·2 g/d n-3PUFA) and safflower oil (SO). At baseline and after each period, we measured primary outcomes: attention (d2-test) and spatial working memory (Corsi test) and secondary outcomes: flexibility (Stroop word-colour test), ADHD symptoms (Conners scales), executive functions (Behavioural Inventory of Executive Function) and social behaviour (Social Responsiveness Scale). The dropout rate was 15 %. Compliance was 94 % and correlated with whole-blood n-3LCPUFA. Corsi scores improved by ∼0·3 × sd (P = 0·032) after FO v. SO, and the odds for d2 errors were 30 % lower (P = 0·016), which was supported by improved Conners scores of attention (P = 0·023). Improvement in Conners ADHD symptom score was limited to participants with ADHD (-3·5(-6·0; -1·0), n 10 v. -0·2(-2·5;2·2), n 11 without ADHD, Pinteraction = 0·096), who also improved their behavioural regulation index by 0·3 × sd after FO (Pinteraction = 0·016). Participants without ADHD gained most in d2 test performance (OR = 0·4(0·2;0·7) v. 0·9(0·6;1·3) in those with ADHD, Pinteraction = 0·002), but their executive function score was exacerbated after FO (5·9(0·0,11·8), Pinteraction = 0·039). Our results did not show any effects on ASD symptoms, but suggest that FO may improve attention and working memory in adults with ASD and ameliorate ADHD symptoms in those with comorbid ADHD.",2022,"Corsi scores improved by ∼0.3×SD (P=0.032) after FO vs SO, and the odds for d2 errors were 30% lower (P=0.016), which was supported by improved Conners scores of attention (P=0.023).","['adults with ASD', 'adults with autism spectrum disorder (ASD', 'children with attention-deficit/hyperactivity disorder (ADHD', '26 participants', 'adults with autism spectrum disorder']","['Marine n-3 fatty acids (n-3LCPUFA', 'Fish oil supplementation', 'supplementation with fish oil (FO, 5.2 g/d n-3PUFA) and safflower oil (SO', 'n-3LCPUFA']","['Corsi scores', 'dropout rate', 'primary outcomes: attention (d2-test) and spatial working memory (Corsi test) and secondary outcomes: flexibility (Stroop word-colour test), ADHD symptoms (Conners scales), executive functions (Behavioural Inventory of Executive Function) and social behaviour (Social Responsiveness Scale', 'Compliance', 'attention, working memory, and ADHD symptoms', 'Conners ADHD symptom score', 'attention and working memory', 'executive function score', 'behavioural regulation index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0036048', 'cui_str': 'Safflower Oil'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",26.0,0.105199,"Corsi scores improved by ∼0.3×SD (P=0.032) after FO vs SO, and the odds for d2 errors were 30% lower (P=0.016), which was supported by improved Conners scores of attention (P=0.023).","[{'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Lundbergh', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Ann Sofi', 'Initials': 'AS', 'LastName': 'Enevoldsen', 'Affiliation': 'Private Medical Practice, Copenhagen, Denmark.'}, {'ForeName': 'Ken D', 'Initials': 'KD', 'LastName': 'Stark', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Ontario, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Lauritzen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}]",The British journal of nutrition,['10.1017/S0007114522000393']
1949,35148329,"Cost-utility analysis of community occupational therapy in dementia (COTiD-UK) versus usual care: Results from VALID, a multi-site randomised controlled trial in the UK.","BACKGROUND


A community-based occupational therapy intervention for people with mild to moderate dementia and their family carers: the Community Occupational Therapy in Dementia-UK version (COTiD-UK); and Treatment as usual (TAU) were randomly assigned to 468 pairs (each comprising a person with dementia and a family carer) in the Valuing Active Life in Dementia (VALID) randomised controlled trial (RCT).
OBJECTIVES


To compare the cost-utility of the COTiD-UK intervention compared to TAU, using data from the VALID RCT.
METHODS


We performed a cost-utility analysis estimating mean costs and quality adjusted life years (QALYs) per person with dementia and carer for both treatments over a 26 weeks' time horizon based on resource use data and utility values collected in the trial.
RESULTS


Taking the National Health Service and Personal Social Services perspective, including costs and benefits to the person with dementia only, measuring Health Related Quality of Life based on Dementia Quality of Life scale (DEMQOL), accounting for missing data and adjusting for baseline values, there was a significant difference in costs between COTiD-UK and TAU (mean incremental cost for COTiD-UK £784 (95% CI £233 to £1334)), but no significant difference in outcomes (mean QALYs gained 0.00664 (95% CI -0.00404, 0.01732)). The Incremental Net Monetary Benefit (INMB) for COTiD-UK versus TAU was negative at a maximum willingness to pay for a QALY of £20000 (mean -£651, 95% CI -£878 to -£424) or £30000 (mean -£585, 95% CI -£824 to -£345). Extensive sensitivity analyses confirmed the results.
CONCLUSIONS


This community-based occupational therapy intervention has a very low probability of being cost-effective.",2022,"The Incremental Net Monetary Benefit (INMB) for COTiD-UK versus TAU was negative at a maximum willingness to pay for a QALY of £20000 (mean -£651, 95% CI -£878 to -£424) or £30000 (mean -£585, 95% CI -£824 to -£345).","['468 pairs (each comprising a person with dementia and a family carer) in the Valuing Active Life in Dementia (VALID) randomised controlled trial (RCT', 'people with mild to moderate dementia and their family carers']","['COTiD-UK intervention', 'community-based occupational therapy intervention', 'community occupational therapy']","['cost-utility', 'costs between COTiD-UK and TAU', 'Dementia Quality of Life scale (DEMQOL', 'mean costs and quality adjusted life years (QALYs) per person with dementia and carer']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",,0.110455,"The Incremental Net Monetary Benefit (INMB) for COTiD-UK versus TAU was negative at a maximum willingness to pay for a QALY of £20000 (mean -£651, 95% CI -£878 to -£424) or £30000 (mean -£585, 95% CI -£824 to -£345).","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pizzo', 'Affiliation': 'Department of Applied Health Research, University College London, London, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wenborn', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Burgess', 'Affiliation': 'Research & Development Department, North East London NHS Foundation Trust (NELFT), London, United Kingdom.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Mundy', 'Affiliation': 'Essex Stroke Hub Team, North East London NHS Foundation Trust (NELFT), London, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orrell', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Rumana', 'Initials': 'R', 'LastName': 'Omar', 'Affiliation': 'Priment Clinical Trials Unit, Faculty of Brain Sciences, University College London, London, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0262828']
1950,35150610,"High-titre methylene blue-treated convalescent plasma as an early treatment for outpatients with COVID-19: a randomised, placebo-controlled trial.","BACKGROUND


Convalescent plasma has been proposed as an early treatment to interrupt the progression of early COVID-19 to severe disease, but there is little definitive evidence. We aimed to assess whether early treatment with convalescent plasma reduces the risk of hospitalisation and reduces SARS-CoV-2 viral load among outpatients with COVID-19.
METHODS


We did a multicentre, double-blind, randomised, placebo-controlled trial in four health-care centres in Catalonia, Spain. Adult outpatients aged 50 years or older with the onset of mild COVID-19 symptoms 7 days or less before randomisation were eligible for enrolment. Participants were randomly assigned (1:1) to receive one intravenous infusion of either 250-300 mL of ABO-compatible high anti-SARS-CoV-2 IgG titres (EUROIMMUN ratio ≥6) methylene blue-treated convalescent plasma (experimental group) or 250 mL of sterile 0·9% saline solution (control). Randomisation was done with the use of a central web-based system with concealment of the trial group assignment and no stratification. To preserve masking, we used opaque tubular bags that covered the investigational product and the infusion catheter. The coprimary endpoints were the incidence of hospitalisation within 28 days from baseline and the mean change in viral load (in log 10  copies per mL) in nasopharyngeal swabs from baseline to day 7. The trial was stopped early following a data safety monitoring board recommendation because more than 85% of the target population had received a COVID-19 vaccine. Primary efficacy analyses were done in the intention-to-treat population, safety was assessed in all patients who received the investigational product. This study is registered with ClinicalTrials.gov, NCT04621123.
FINDINGS


Between Nov 10, 2020, and July 28, 2021, we assessed 909 patients with confirmed COVID-19 for inclusion in the trial, 376 of whom were eligible and were randomly assigned to treatment (convalescent plasma n=188 [serum antibody-negative n=160]; placebo n=188 [serum antibody-negative n=166]). Median age was 56 years (IQR 52-62) and the mean symptom duration was 4·4 days (SD 1·4) before random assignment. In the intention-to-treat population, hospitalisation within 28 days from baseline occurred in 22 (12%) participants who received convalescent plasma versus 21 (11%) who received placebo (relative risk 1·05 [95% CI 0·78 to 1·41]). The mean change in viral load from baseline to day 7 was -2·41 log 10  copies per mL (SD 1·32) with convalescent plasma and -2·32 log 10  copies per mL (1·43) with placebo (crude difference -0·10 log 10  copies per mL [95% CI -0·35 to 0·15]). One participant with mild COVID-19 developed a thromboembolic event 7 days after convalescent plasma infusion, which was reported as a serious adverse event possibly related to COVID-19 or to the experimental intervention.
INTERPRETATION


Methylene blue-treated convalescent plasma did not prevent progression from mild to severe illness and did not reduce viral load in outpatients with COVID-19. Therefore, formal recommendations to support the use of convalescent plasma in outpatients with COVID-19 cannot be concluded.
FUNDING


Grifols, Crowdfunding campaign YoMeCorono.",2022,"INTERPRETATION


Methylene blue-treated convalescent plasma did not prevent progression from mild to severe illness and did not reduce viral load in outpatients with COVID-19.","['four health-care centres in Catalonia, Spain', 'Adult outpatients aged 50 years or older with the onset of mild COVID-19 symptoms 7 days or less before randomisation were eligible for enrolment', 'outpatients with COVID-19', 'Between Nov 10, 2020, and July 28, 2021, we assessed 909 patients with confirmed COVID-19 for inclusion in the trial, 376 of whom were eligible and were randomly assigned to treatment (convalescent plasma n=188 ']","['placebo', 'High-titre methylene blue-treated convalescent plasma', 'COVID-19 vaccine', 'intravenous infusion of either 250-300 mL of ABO-compatible high anti-SARS-CoV-2 IgG titres (EUROIMMUN ratio ≥6) methylene blue-treated convalescent plasma (experimental group) or 250 mL of sterile 0·9% saline solution (control']","['mean change in viral load', 'risk of hospitalisation and reduces SARS-CoV-2 viral load', 'intention-to-treat population, safety', 'mean symptom duration', 'incidence of hospitalisation within 28 days from baseline and the mean change in viral load', 'thromboembolic event']","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}]",909.0,0.758255,"INTERPRETATION


Methylene blue-treated convalescent plasma did not prevent progression from mild to severe illness and did not reduce viral load in outpatients with COVID-19.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Alemany', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain; Infectious Diseases Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Facultat de Medicina, Universitat de Barcelona, Barcelona, Spain. Electronic address: aalemany@flsida.org.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Millat-Martinez', 'Affiliation': 'ISGlobal, Hospital Clinic, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Corbacho-Monné', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain; Infectious Diseases Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Facultat de Medicina, Universitat de Barcelona, Barcelona, Spain; Hospital Universitari Parc Taulí, I3PT, Sabadell, Spain.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Malchair', 'Affiliation': 'Emergency Department, Bellvitge University Hospital, Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ouchi', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain; Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ruiz-Comellas', 'Affiliation': ""Unitat de Suport a la Recerca de la Catalunya Central, Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Sant Fruitós de Bages, Spain; Health Promotion in Rural Areas Research Group, Gerència Territorial de la Catalunya Central, Institut Català de la Salut, Sant Fruitós de Bages, Spain; Universitat de Vic-Universitat Central de Catalunya, Vic, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ramírez-Morros', 'Affiliation': ""Unitat de Suport a la Recerca de la Catalunya Central, Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Sant Fruitós de Bages, Spain.""}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Rodríguez Codina', 'Affiliation': 'Salut Catalunya Central, Hospital de Berga, Berga, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Amado Simon', 'Affiliation': 'Salut Catalunya Central, Hospital de Berga, Berga, Spain.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Videla', 'Affiliation': ""Fight AIDS and Infectious Diseases Foundation, Badalona, Spain; Clinical Research Support Unit, HUB-IDIBELL, Bellvitge University Hospital and Bellvitge Biomedical Research Institute, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain; Pharmacology Unit, Department of Pathology and Experimental Therapeutics, School of Medicine and Health Sciences, IDIBELL, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Gèlia', 'Initials': 'G', 'LastName': 'Costes', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Capdevila-Jáuregui', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Torrano-Soler', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'San José', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Glòria', 'Initials': 'G', 'LastName': 'Bonet Papell', 'Affiliation': 'Infectious Diseases Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Puig', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Aurema', 'Initials': 'A', 'LastName': 'Otero', 'Affiliation': ""Emergency Department, Bellvitge University Hospital, Hospitalet de Llobregat, Spain; Clinical Research Support Unit, HUB-IDIBELL, Bellvitge University Hospital and Bellvitge Biomedical Research Institute, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Jose Carlos', 'Initials': 'JC', 'LastName': 'Ruibal Suarez', 'Affiliation': 'Emergency Department, Bellvitge University Hospital, Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Zarauza Pellejero', 'Affiliation': 'Emergency Department, Bellvitge University Hospital, Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Llopis Roca', 'Affiliation': 'Emergency Department, Bellvitge University Hospital, Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Orlando', 'Initials': 'O', 'LastName': 'Rodriguez Cortez', 'Affiliation': 'Emergency Department, Bellvitge University Hospital, Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Garcia Garcia', 'Affiliation': 'Emergency Department, Bellvitge University Hospital, Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Vidal-Alaball', 'Affiliation': ""Unitat de Suport a la Recerca de la Catalunya Central, Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Sant Fruitós de Bages, Spain; Health Promotion in Rural Areas Research Group, Gerència Territorial de la Catalunya Central, Institut Català de la Salut, Sant Fruitós de Bages, Spain; Universitat de Vic-Universitat Central de Catalunya, Vic, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Millan', 'Affiliation': 'Blood Bank Department, Banc de Sang i Teixits, Barcelona, Spain.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Contreras', 'Affiliation': 'Blood Bank Department, Banc de Sang i Teixits, Barcelona, Spain.'}, {'ForeName': 'Joan-Ramon', 'Initials': 'JR', 'LastName': 'Grifols', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain; Blood Bank Department, Banc de Sang i Teixits, Barcelona, Spain.'}, {'ForeName': 'Àgueda', 'Initials': 'À', 'LastName': 'Ancochea', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain; Blood Bank Department, Banc de Sang i Teixits, Barcelona, Spain.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Galvan-Femenia', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain; Institute for Research in Biomedicine, The Barcelona Institute of Science and Technology, Barcelona, Spain.'}, {'ForeName': 'Francini', 'Initials': 'F', 'LastName': 'Piccolo Ferreira', 'Affiliation': 'Bioclever, Barcelona, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Bonet', 'Affiliation': 'Bioclever, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Cantoni', 'Affiliation': 'Bioclever, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Prat', 'Affiliation': 'Gerència Territorial Metropolitana Nord, Institut Català de la Salut, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Ara', 'Affiliation': 'Universitat Autònoma de Barcelona, Barcelona, Spain; Gerència Territorial Metropolitana Nord, Institut Català de la Salut, Barcelona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forcada Arcarons', 'Affiliation': 'Gerència Territorial de la Catalunya Central, Institut Català de la Salut, Barcelona, Spain.'}, {'ForeName': 'Magí', 'Initials': 'M', 'LastName': 'Farré', 'Affiliation': 'Infectious Diseases Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Edwards', 'Initials': 'E', 'LastName': 'Pradenas', 'Affiliation': 'IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute, Can Ruti Campus, Badalona, Spain.'}, {'ForeName': 'Julià', 'Initials': 'J', 'LastName': 'Blanco', 'Affiliation': 'Universitat de Vic-Universitat Central de Catalunya, Vic, Spain; IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute, Can Ruti Campus, Badalona, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Àngel Rodriguez-Arias', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Fernández Rivas', 'Affiliation': 'Microbiology Department, Clinical Laboratory Metropolitana Nord, Badalona, Barcelona, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marks', 'Affiliation': 'Hospital for Tropical Diseases, London, UK; Clinical Research Department, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Quique', 'Initials': 'Q', 'LastName': 'Bassat', 'Affiliation': 'ISGlobal, Hospital Clinic, Universitat de Barcelona, Barcelona, Spain; Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública, Madrid, Spain; ICREA, Pg Lluís Companys 23, Barcelona, Spain; Pediatrics Department, Hospital Sant Joan de Déu, Universitat de Barcelona, Esplugues, Barcelona, Spain; Centro de Investigação em Saúde de Manhiça, Maputo, Mozambique.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Blanco', 'Affiliation': 'Management Department, Clinical Laboratory Metropolitana Nord, Badalona, Barcelona, Spain.'}, {'ForeName': 'Bàrbara', 'Initials': 'B', 'LastName': 'Baro', 'Affiliation': 'ISGlobal, Hospital Clinic, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Bonaventura', 'Initials': 'B', 'LastName': 'Clotet', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain; Infectious Diseases Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Universitat Autònoma de Barcelona, Barcelona, Spain; Universitat de Vic-Universitat Central de Catalunya, Vic, Spain; IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute, Can Ruti Campus, Badalona, Spain.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Mitjà', 'Affiliation': 'Fight AIDS and Infectious Diseases Foundation, Badalona, Spain; Infectious Diseases Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Universitat de Vic-Universitat Central de Catalunya, Vic, Spain; Lihir Medical Centre, International SOS, Lihir Island, Papua New Guinea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00545-2']
1951,35150804,Comparing surgeons' skin tolerance and acceptability to alcohol-based surgical hand preparation vs traditional surgical scrub: A matched quasi-experimental study.,"BACKGROUND


We aimed to compare the tolerance and acceptability of alcohol-based surgical hand preparation versus handscrubbing with antimicrobial soap and water by surgeons.
METHODS


Matched quasi-experimental trial in an academic quaternary care hospital in Ribeirão Preto, Brazil, from April 1 to October, 31, 2017. Participants were cardiac and orthopedics surgeons from the study facility. In the first study phase, they performed handscrubbing with either 2% chlorhexidine (CHG) or 10% iodopovidone (PVP-I) and, in the second phase, they performed handrubbing with alcohol-based handrub (ABHR). Surgeons' skin tolerance and acceptability were evaluated using WHO-validated tools. Data were analyzed using the MacNemar's test within STATA.
RESULTS


A total of 33 surgeons participated to the ""per protocol"" population; the majority were male (94%); mean age of 35 years (SD, 8.5). On product tolerance, there was a minimal variation in redness, scaliness, fissures, and visual evaluation of the skin when handrubbing with ABHR was compared to handscrubbing with either PVP-I or CHX. Regarding acceptability, participants rated better handrubbing with ABHR than handscrubbing with PVP-I when assessing product smell (66.6% vs 0%, p=0.002), color (73.3% vs 0%, p=0.001), product texture (60% vs 0%, p=0.004), skin dryness (60% vs 0%, p=0.004), ease of application (66.6% vs 0%, p=0.002) and overall satisfaction (66.6% vs 6.7% p=0.011). Participants rated similarly handrubbing with ABHR and handscrubbing with CHX, except for product texture, where handrubbing rated better (71,4% vs. 0%, p=0.002). Handrubbing with ABHR was preferred by 73.3%.
CONCLUSION


Although handrubbing and handscrubbing were equally well tolerated by surgeons, alcohol-based surgical hand preparation fell into the personal preference for most of them.
TRIAL REGISTRATION


Brazilian Clinical Trials Registry (ReBEC), RBR-8ym9yj.",2022,"On product tolerance, there was a minimal variation in redness, scaliness, fissures, and visual evaluation of the skin when handrubbing with ABHR was compared to handscrubbing with either PVP-I or CHX.","['mean aged of 35 years (SD, 8.5', '33 surgeons participated to the ""per protocol"" population; the majority were male (94', ' Participants performed handscrubbing with either 2']","['alcohol-based surgical hand preparation versus handscrubbing with antimicrobial soap and water by surgeons', 'PVP-I or CHX', 'chlorhexidine (CHG) or 10% iodopovidone (PVP-I) and in the second phase, performed handrubbing with alcohol-based handrub (ABHR', 'alcohol-based surgical hand preparation versus traditional surgical scrub']","['skin dryness', 'product smell', 'redness, scaliness, fissures, and visual evaluation of the skin', ""Surgeons' skin tolerance and acceptability"", 'overall satisfaction', 'ease of application', 'product texture']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C2936698', 'cui_str': 'Scrubbing, Surgical'}]","[{'cui': 'C0151908', 'cui_str': 'Dry skin'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0332469', 'cui_str': 'Fissure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449582', 'cui_str': 'With texture'}]",33.0,0.0464442,"On product tolerance, there was a minimal variation in redness, scaliness, fissures, and visual evaluation of the skin when handrubbing with ABHR was compared to handscrubbing with either PVP-I or CHX.","[{'ForeName': 'Ana Elisa Ricci', 'Initials': 'AER', 'LastName': 'Lopes', 'Affiliation': 'Department of Fundamental Nursing, Ribeirão Preto Nursing School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Mayra Gonçalves', 'Initials': 'MG', 'LastName': 'Menegueti', 'Affiliation': 'Department of Fundamental Nursing, Ribeirão Preto Nursing School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Gilberto Gambero', 'Initials': 'GG', 'LastName': 'Gaspar', 'Affiliation': 'Infection Control Service, University Hospital of Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Ermira', 'Initials': 'E', 'LastName': 'Tartari', 'Affiliation': 'Faculty of Health Sciences, University of Malta, Msida, Malta.'}, {'ForeName': 'Silvia Rita Marin', 'Initials': 'SRM', 'LastName': 'da Silva Canini', 'Affiliation': 'Department of Fundamental Nursing, Ribeirão Preto Nursing School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Pittet', 'Affiliation': 'Infection Prevention and Control Program, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bellissimo-Rodrigues', 'Affiliation': 'Social Medicine Department, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil. Electronic address: fbellissimo@usp.br.'}]",American journal of infection control,['10.1016/j.ajic.2022.01.028']
1952,35150773,Promising results from a residential rehabilitation intervention focused on fatigue and the secondary psychological and physical consequences of cardiac arrest: The SCARF feasibility study.,"AIMS


This study investigated the feasibility and potential effect of SCARF (Survivors of Cardiac ARest focused on Fatigue) a multidisciplinary residential rehabilitation intervention focused on fatigue and the secondary psychological and physical consequences of cardiac arrest (CA).
METHODS


This was a prospective one-armed feasibility study. Six progression criteria were identified related to the feasibility of the intervention and viability of a future effect study in terms of: participant recruitment (1), participant retention (2,3,4), and completeness of outcomes (5,6). Data on participant/clinician satisfaction with the intervention was also collected along with self-reported outcomes: fatigue, quality of life, anxiety, depression, function and disability, and physical activity (at baseline, 12 weeks and 6 months) and physical capacity (baseline and 12 weeks).
RESULTS


Four progression criteria were met including retention (87.5%) and completion of baseline outcomes (97.5%). Two criteria were not met: recruitment rate was 2.9 participants per month (estimated rate needed 6.1) and completion of final outcomes was 65% (estimated proportion needed 75%). Participant/clinician satisfaction with the intervention was high. Three months after the SCARF intervention small to moderate effect size changes of r = 0.18-0.46 were found for self-reported fatigue, quality of life, anxiety, depression, function and disability and for two of the physical capacity tests (d = 0.46-0.52).
CONCLUSION


SCARF was found to be a feasible intervention with high participant/clinician satisfaction, high participant retention and the possible potential to improve self-reported and physical capacity outcomes. Procedures for study recruitment and collection of final outcomes should be modified before a fully powered randomised controlled trial is conducted.",2022,"Three months after the SCARF intervention small to moderate effect size changes of r=0.18-0.46 were found for self-reported fatigue, quality of life, anxiety, depression and disability and for two of the physical capacity tests (d=0.46-0.52).
",[],"['residential rehabilitation intervention', 'SCARF']","['fatigue, quality of life, anxiety, depression and disability', 'physical capacity', 'outcomes: fatigue, quality of life, anxiety, depression, function and disability, and physical activity']",[],"[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0452258', 'cui_str': 'Scarf'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",2.0,0.166322,"Three months after the SCARF intervention small to moderate effect size changes of r=0.18-0.46 were found for self-reported fatigue, quality of life, anxiety, depression and disability and for two of the physical capacity tests (d=0.46-0.52).
","[{'ForeName': 'Vicky L', 'Initials': 'VL', 'LastName': 'Joshi', 'Affiliation': 'REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital, Nyborg, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark, Studiestraede 6, 1455 Copenhagen, Denmark. Electronic address: victoria.louise.joshi@rsyd.dk.'}, {'ForeName': 'Lars Hermann', 'Initials': 'LH', 'LastName': 'Tang', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Denmark; The Department of Regional Health Research, University of Southern Denmark, Denmark.'}, {'ForeName': 'Young Joo', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': '600 Moye Blvd, MS668, HSB3305, Department of Occupational Therapy, College of Allied Health Sciences, East Carolina University, Greenville, NC 27834, USA.'}, {'ForeName': 'Mette Kirstine', 'Initials': 'MK', 'LastName': 'Wagner', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen, Denmark.'}, {'ForeName': 'Jørgen Feldbæk', 'Initials': 'JF', 'LastName': 'Nielsen', 'Affiliation': 'Hammel Neurorehabilitation Centre and University Research Clinic, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Midtjylland, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Tjoernlund', 'Affiliation': 'Center for Rehabilitation of Brain Injury, Amagerfaelledvej 56 A, 2300 København S, Denmark.'}, {'ForeName': 'Ann-Dorthe', 'Initials': 'AD', 'LastName': 'Zwisler', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J.B. Winsloews Vej, 5000 Odense, Denmark; REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital, Nyborg, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark, Studiestraede 6, 1455 Copenhagen, Denmark.'}]",Resuscitation,['10.1016/j.resuscitation.2022.02.002']
1953,35151182,Effectiveness of a community organizing intervention on mortality and its equity among older residents in Japan: A JAGES quasi-experimental study.,"Interventions that involve key aspects of community organizing, such as quantitative community assessments and organizational partnership support for the community, may promote residents' health. We evaluated the effectiveness of this form of intervention on mortality and its variability across individual-level household equivalized income tertiles, comparing 52,858 residents aged 65 and above in 12 intervention municipalities to 39,006 residents in nine control municipalities in Japan. During 1,166 days of follow-up, the adjusted hazard ratio for cumulative mortality among men in the intervention municipalities was 0.92 (95% confidence interval: 0.86, 0.99) compared to those in the control group, with similar results being observed across all income levels. Active utilization of data to evaluate communities and building intersectoral partnerships might lower older male residents' mortality risk, regardless of their income status.",2022,"During 1,166 days of follow-up, the adjusted hazard ratio for cumulative mortality among men in the intervention municipalities was 0.92 (95% confidence interval: 0.86, 0.99) compared to those in the control group, with similar results being observed across all income levels.","['52,858 residents aged 65 and above in 12 intervention municipalities to 39,006 residents in nine control municipalities in Japan', 'older residents in Japan']",['community organizing intervention'],"['adjusted hazard ratio for cumulative mortality', 'mortality and its equity']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.034638,"During 1,166 days of follow-up, the adjusted hazard ratio for cumulative mortality among men in the intervention municipalities was 0.92 (95% confidence interval: 0.86, 0.99) compared to those in the control group, with similar results being observed across all income levels.","[{'ForeName': 'Maho', 'Initials': 'M', 'LastName': 'Haseda', 'Affiliation': 'Department of Health Education and Health Sociology, School of Public Health, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo, 113-0033, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Takagi', 'Affiliation': 'Department of Health and Social Behavior, School of Public Health, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo, 113-0033, Japan.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Stickley', 'Affiliation': 'Department of Health Education and Health Sociology, School of Public Health, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo, 113-0033, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Kondo', 'Affiliation': 'Center for Preventive Medical Sciences, Chiba University, 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 360-0856, Japan; Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, 7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kondo', 'Affiliation': 'Department of Health Education and Health Sociology, School of Public Health, The University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: kondo.naoki.0s@kyoto-u.ac.jp.'}]",Health & place,['10.1016/j.healthplace.2022.102764']
1954,35131646,"Ribociclib plus letrozole in subgroups of special clinical interest with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: Subgroup analysis of the phase IIIb CompLEEment-1 trial.","BACKGROUND


The phase IIIb CompLEEment-1 study evaluated ribociclib plus letrozole in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Outcomes were investigated in the following subgroups: central nervous system (CNS) metastases, prior chemotherapy for advanced disease, Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2, and visceral metastases plus prior chemotherapy for advanced disease or ECOG PS 2.
PATIENTS AND METHODS


Patients with HR+, HER2- ABC without prior hormonal treatment for advanced disease received oral ribociclib (600 mg once daily, 3 weeks on/1 week off) plus letrozole (2.5 mg once daily, continuous). Primary endpoint was safety/tolerability, assessed via occurrence of adverse events (AEs); key secondary endpoints included time to progression (TTP), overall response rate, and clinical benefit rate.
RESULTS


51 patients had CNS metastases, 194 received prior chemotherapy for advanced disease, 112 had ECOG PS 2, 146 had visceral metastases plus prior chemotherapy, and 77 had visceral metastases plus ECOG PS 2. Safety results were consistent with those in the overall CompLEEment-1 population; no new safety concerns were identified. The AE profile was manageable with low rates of discontinuations due to AEs. TTP in patients with CNS metastases was consistent with the overall study population and shorter for other patient subgroups. Each patient subgroup achieved meaningful clinical benefit from treatment, consistent with the overall population.
CONCLUSION


These findings confirm the clinical benefit of ribociclib plus endocrine therapy in high-risk patient subgroups of clinical interest commonly underrepresented in clinical trials.",2022,The AE profile was manageable with low rates of discontinuations due to AEs.,"['advanced disease, Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2, and visceral metastases plus prior chemotherapy for advanced disease or ECOG PS 2', 'patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC', '51 patients had CNS metastases, 194 received prior chemotherapy for advanced disease, 112 had ECOG PS 2, 146 had visceral metastases plus prior chemotherapy, and 77 had visceral metastases plus ECOG PS 2', 'patients with CNS metastases', 'Patients with HR+, HER2- ABC without prior hormonal treatment for advanced disease received']","['letrozole', 'ribociclib plus letrozole', 'TTP', 'Ribociclib plus letrozole', 'oral ribociclib', 'ribociclib plus endocrine therapy']","['safety/tolerability, assessed via occurrence of adverse events (AEs); key secondary endpoints included time to progression (TTP), overall response rate, and clinical benefit rate', 'central nervous system (CNS) metastases']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0279130', 'cui_str': 'CNS metastases'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034155', 'cui_str': 'Thrombotic thrombocytopenic purpura'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}]",,0.370117,The AE profile was manageable with low rates of discontinuations due to AEs.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cottu', 'Affiliation': 'Department of Medical Oncology, Curie Institute, Paris, France. Electronic address: paul.cottu@curie.fr.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Ring', 'Affiliation': 'Royal Marsden Hospital NHS Foundation Trust, Sutton, United Kingdom.'}, {'ForeName': 'Hikmat', 'Initials': 'H', 'LastName': 'Abdel-Razeq', 'Affiliation': 'King Hussein Cancer Center, Amman, Jordan.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Marchetti', 'Affiliation': 'Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': 'Breast Unit, Champalimaud Clinical Centre, Champalimaud Foundation, Lisbon, Portugal.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Salvador Bofill', 'Affiliation': 'Virgen del Rocio University Hospital, Biomedicine Institute, Seville, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martín', 'Affiliation': 'Gregorio Marañón General University Hospital, Madrid, Spain.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Menon-Singh', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Jiwen', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Michelino', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione Pascale"", Naples, Italy.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2022.01.016']
1955,35131634,Anodal tDCS of contralesional hemisphere modulates ipsilateral control of spinal motor networks targeting the paretic arm post-stroke.,"OBJECTIVE


The role of ipsilateral motor cortex efferent pathways in the transmission of voluntary command to spinal motor nuclei remains controversial in humans. In healthy subjects, their implication in cortical control is hidden by predominant role of crossed corticospinal tract. However, evidence from electrophysiological and imaging studies suggest that ipsilateral tracts may contribute to functional recovery after unilateral brain damage. This randomized-sham control study aims to explore to what extent ipsilateral tracts from the undamaged hemisphere may strengthen corticospinal control onto spinal motor networks following stroke.
METHODS


Anodal transcranial direct current stimulation (tDCS) was combined with monosynaptic H-reflex method to evaluate the variations of reciprocal inhibition (RI) in wrist flexors in 21 stroke participants.
RESULTS


Anodal tDCS decreased RI in wrist flexors in stroke participants in both arms. tDCS unmasks an ipsilateral control from the undamaged hemisphere onto spinal motor networks controlling affected arm muscles in stroke participants. In the unaffected (contralateral) arm, effects in stroke participants were opposite to those induced in healthy subjects.
CONCLUSIONS


Stimulation of the undamaged cortex in stroke participants induces modulation of ipsilateral motor networks controlling the hemiparetic side.
SIGNIFICANCE


Rehabilitation could leverage stimulation of the undamaged hemisphere to enhance motor recovery post stroke.",2022,tDCS unmasks an ipsilateral control from the undamaged hemisphere onto spinal motor networks controlling affected arm muscles in stroke participants.,"['healthy subjects', '21 stroke participants', 'stroke participants', 'humans']","['Anodal tDCS', 'Anodal transcranial direct current stimulation (tDCS']",['RI in wrist flexors'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0683266', 'cui_str': 'Reciprocal inhibition'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}]",21.0,0.0447499,tDCS unmasks an ipsilateral control from the undamaged hemisphere onto spinal motor networks controlling affected arm muscles in stroke participants.,"[{'ForeName': 'Wanalee', 'Initials': 'W', 'LastName': 'Klomjai', 'Affiliation': 'Faculty of Physical Therapy, Mahidol University, 73170 Nakonpathom, Thailand.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Giron', 'Affiliation': ""Sorbonne Université, CNRS, INSERM, Laboratoire d'Imagerie Biomédicale, LIB, F-75005 Paris, France.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Mounir El Mendili', 'Affiliation': 'Aix Marseille Univ, CRMBM, CNRS, Marseille, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Aymard', 'Affiliation': 'Fondation Hospitalière Sainte Marie, Centre Paris Sud, 75014 Paris, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Pradat-Diehl', 'Affiliation': ""Sorbonne Université, CNRS, INSERM, Laboratoire d'Imagerie Biomédicale, LIB, F-75005 Paris, France; APHP, Hôpital Pitié-Salpêtrière, Service de Médecine Physique et Réadaptation, F-75013 Paris, France; Sorbonne Université, GRC n°24, Handicap Moteur & Cognitif et Réadaptation, APHP, Hôpital de la Pitié Salpêtrière, F-75013 Paris, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Roche', 'Affiliation': ""Université Versailles-Saint-Quentin, INSERM U1179, 92380 Garches, France; APHP, Hôpital Raymond Poincaré, Service de Physiologie et d'explorations fonctionnelles, 92380 Garches, France.""}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': ""Sorbonne Université, CNRS, INSERM, Laboratoire d'Imagerie Biomédicale, LIB, F-75005 Paris, France; APHP, Hôpital Pitié-Salpêtrière, Service de Médecine Physique et Réadaptation, F-75013 Paris, France; Sorbonne Université, GRC n°24, Handicap Moteur & Cognitif et Réadaptation, APHP, Hôpital de la Pitié Salpêtrière, F-75013 Paris, France.""}, {'ForeName': 'Eléonore', 'Initials': 'E', 'LastName': 'Bayen', 'Affiliation': ""Sorbonne Université, CNRS, INSERM, Laboratoire d'Imagerie Biomédicale, LIB, F-75005 Paris, France; APHP, Hôpital Pitié-Salpêtrière, Service de Médecine Physique et Réadaptation, F-75013 Paris, France; Sorbonne Université, GRC n°24, Handicap Moteur & Cognitif et Réadaptation, APHP, Hôpital de la Pitié Salpêtrière, F-75013 Paris, France.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Lackmy-Vallee', 'Affiliation': ""Sorbonne Université, CNRS, INSERM, Laboratoire d'Imagerie Biomédicale, LIB, F-75005 Paris, France. Electronic address: alexandra.lackmy-vallee@sorbonne-universite.fr.""}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2021.12.016']
1956,35131614,Wingman-Connect Program increases social integration for Air Force personnel at elevated suicide risk: Social network analysis of a cluster RCT.,"U.S. military suicides are increasing and disrupted relationships frequently precede them. Group-level interventions are needed that reduce future suicide vulnerability among healthy members and also ameliorate risk among those already suicidal. We examined whether our Wingman-Connect Program (W-CP) strengthened Air Force relationship networks and socially integrated at-risk members. Air Force personnel classes in training were randomized to W-CP or active control (cluster RCT), followed up at 1 and 6 months (94% and 84% retention). Data were collected in 2017-2019 and analyzed in 2020-2021. Participants were 1485 male and female Airmen in 215 technical training classes. W-CP training involved strengthening group bonds, skills for managing career and personal stressors, and diffusion of healthy norms. Active control was stress management training. Primary outcomes were social network metrics based on Airmen nominations of valued classmates after 1 month. Baseline CAT-SS >34 defined elevated suicide risk. W-CP increased social network integration, with largest impact for Airmen already at elevated suicide risk (n = 114, 7.7%). For elevated risk Airmen, W-CP improved all network integration metrics, including 53% average gain in valued connection nominations received from other Airmen (RR = 1.53, 95% CI = 1.12, 2.08) and eliminated isolation. No elevated risk Airmen in W-CP were isolates with no valued connections after 1-month vs. 10% among controls (P < .035). In contrast to at-risk controls, at-risk W-CP Airmen increased connections after intervention. W-CP's effect on a key indicator, ≥2 connections, was still greater 2-4 months after classes disbanded (6-months). Wingman-Connect Program built enhanced suicide protection into unit relationship networks and counteracted standard drift towards disconnection for at-risk Airmen, despite no explicit content targeting connections specifically to at-risk Airmen. Findings support a growing case for the unique contribution of group-level interventions to improve social health of broader military populations while also ameliorating risk among individuals already at elevated suicide risk.",2022,"For elevated risk Airmen, W-CP improved all network integration metrics, including 53% average gain in valued connection nominations received from other Airmen (RR = 1.53, 95% CI = 1.12, 2.08) and eliminated isolation.","['Participants were 1485 male and female Airmen in 215 technical training classes', 'Air Force personnel at elevated suicide risk', 'Data were collected in 2017-2019 and analyzed in 2020-2021']","['W-CP training', 'Wingman-Connect Program (W-CP) strengthened Air Force relationship networks']","['social network metrics based on Airmen nominations of valued classmates', 'social network integration']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4521691', 'cui_str': 'US Military enlisted E2'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0392328', 'cui_str': 'Air Force Personnel'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4521691', 'cui_str': 'US Military enlisted E2'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",1485.0,0.0237329,"For elevated risk Airmen, W-CP improved all network integration metrics, including 53% average gain in valued connection nominations received from other Airmen (RR = 1.53, 95% CI = 1.12, 2.08) and eliminated isolation.","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Wyman', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, 300 Crittenden Blvd., Rochester, NY, 14642, USA. Electronic address: peter_wyman@urmc.rochester.edu.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Pickering', 'Affiliation': 'Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Anthony R', 'Initials': 'AR', 'LastName': 'Pisani', 'Affiliation': 'Departments of Psychiatry and Pediatrics, Univeristy of Rochester School of Medicine and Denistry, Rochester, NY, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Cero', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, 300 Crittenden Blvd., Rochester, NY, 14642, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Yates', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, 300 Crittenden Blvd., Rochester, NY, 14642, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Schmeelk-Cone', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, 300 Crittenden Blvd., Rochester, NY, 14642, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hendricks Brown', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Gibbons', 'Affiliation': 'Department of Medicine, The University of Chicago Biological Sciences, IL, USA; Department of Public Health Sciences, The University of Chicago Biological Sciences, IL, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Simonson', 'Affiliation': 'U.S. Air Force, Head Quarters Air Force, Office of Integrated Resilience, The Pentagon, Washington, DC, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Pflanz', 'Affiliation': ""U.S. Air Force Surgeon General's Office, Now with Syracuse Veterans Affairs Medical Center, Syracuse, NY, USA.""}]",Social science & medicine (1982),['10.1016/j.socscimed.2022.114737']
1957,35131596,Association between C-reactive protein levels and antipsychotic treatment during 12 months follow-up period after acute psychosis.,"BACKGROUND


A potential role of inflammatory pathways in the pathology of schizophrenia has been suggested for at least a subgroup of patients. Elevated levels of the inflammatory marker C-reactive protein (CRP) have been observed, with associations to pathogenesis and symptoms. The current evidence regarding effects of antipsychotics on CRP levels is ambiguous.
OBJECTIVES


To examine and compare the influence on CRP levels of three pharmacologically diverse new generation antipsychotics during a one-year follow-up in schizophrenia spectrum disorder.
METHODS


In a multicenter, pragmatic and rater-blinded randomized trial, the effects of amisulpride, aripiprazole and olanzapine were compared in 128 patients with schizophrenia spectrum disorder. All had positive symptoms of psychosis at study entry. Clinical and laboratory assessments including the measurement of CRP levels were conducted at baseline, and 1, 3, 6, 12, 26, 39, and 52 weeks thereafter.
RESULTS


For all antipsychotic drugs analysed together, there was an increase in CRP levels during the one-year follow-up. Aripiprazole, as opposed to amisulpride and olanzapine, was associated with a reduced CRP level after one week, after which the CRP level caught up with the other drugs. Compared to those previously exposed to antipsychotic drugs, antipsychotic-naïve patients had lower CRP levels at all follow-up time points, but with the same temporal patterns of change.
CONCLUSION


Treatment with amisulpride, aripiprazole and olanzapine showed different effects on CRP levels in patients with schizophrenia spectrum disorders, modified by previous antipsychotics exposure status. This finding suggests that antipsychotic drugs may vary with respect to their influence on pro-inflammatory pathways.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT01446328; URL: http://www.clinicaltrials.gov/.",2022,"Compared to those previously exposed to antipsychotic drugs, antipsychotic-naïve patients had lower CRP levels at all follow-up time points, but with the same temporal patterns of change.
","['patients with schizophrenia spectrum disorders', '128 patients with schizophrenia spectrum disorder']","['antipsychotics', 'Aripiprazole', 'amisulpride, aripiprazole and olanzapine', 'amisulpride and olanzapine']","['CRP level', 'CRP levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}]",128.0,0.0924061,"Compared to those previously exposed to antipsychotic drugs, antipsychotic-naïve patients had lower CRP levels at all follow-up time points, but with the same temporal patterns of change.
","[{'ForeName': 'Farivar', 'Initials': 'F', 'LastName': 'Fathian', 'Affiliation': 'Division of Psychiatry and NORMENT Centre of Excellence, Haukeland University Hospital, Bergen, Norway. Electronic address: farivar.fathian@helse-bergen.no.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Gjestad', 'Affiliation': 'Division of Psychiatry and NORMENT Centre of Excellence, Haukeland University Hospital, Bergen, Norway; Faculty of Psychology, Department of Clinical Psychology, University of Bergen, Bergen, Norway; Centre for Research and Education in Forensic Psychiatry, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Rune A', 'Initials': 'RA', 'LastName': 'Kroken', 'Affiliation': 'Division of Psychiatry and NORMENT Centre of Excellence, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Else-Marie', 'Initials': 'EM', 'LastName': 'Løberg', 'Affiliation': 'Division of Psychiatry and NORMENT Centre of Excellence, Haukeland University Hospital, Bergen, Norway; Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway; Faculty of Psychology, Department of Clinical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Solveig Klæbo', 'Initials': 'SK', 'LastName': 'Reitan', 'Affiliation': 'Department of Mental Health, St. Olav University Hospital, 7006 Trondheim, Norway; Department of Mental Health, Faculty of Medicine and Health Sciences, NTNU, Trondheim, Norway.'}, {'ForeName': 'W Wolfgang', 'Initials': 'WW', 'LastName': 'Fleichhacker', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical University of Innsbruck, Innrain 52, Innsbruck, Austria.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rettenbacher', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical University of Innsbruck, Innrain 52, Innsbruck, Austria.'}, {'ForeName': 'Tor K', 'Initials': 'TK', 'LastName': 'Larsen', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway; TIPS, Network for Clinical Research in Psychosis, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Joa', 'Affiliation': 'TIPS, Network for Clinical Research in Psychosis, Stavanger University Hospital, Stavanger, Norway; Faculty of Health, Network for Medical Sciences, University of Stavanger, Stavanger, Norway.'}, {'ForeName': 'Lena Antonsen', 'Initials': 'LA', 'LastName': 'Stabell', 'Affiliation': 'Division of Psychiatry and NORMENT Centre of Excellence, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Eirik', 'Initials': 'E', 'LastName': 'Kjelby', 'Affiliation': 'Division of Psychiatry and NORMENT Centre of Excellence, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Igne', 'Initials': 'I', 'LastName': 'Sinkevicute', 'Affiliation': 'Division of Psychiatry and NORMENT Centre of Excellence, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Alisauskiene', 'Affiliation': 'Division of Psychiatry and NORMENT Centre of Excellence, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Vidar M', 'Initials': 'VM', 'LastName': 'Steen', 'Affiliation': 'NORMENT Centre of Excellence, Department of Clinical Science, University of Bergen, Bergen, Norway; Dr. Einar Martens Research Group for Biological Psychiatry, Department of Medical Genetics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Johnsen', 'Affiliation': 'Division of Psychiatry and NORMENT Centre of Excellence, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}]",Schizophrenia research,['10.1016/j.schres.2022.01.049']
1958,35134128,The Effectiveness and Cost-Effectiveness of Screening and Brief Alcohol Intervention to Reduce Alcohol Consumption in Young People in the High School Setting: A Pragmatic Randomized Controlled Trial (SIPS JR-HIGH).,,2022,,['Young People in the High School Setting'],['Screening and Brief Alcohol Intervention'],['Alcohol Consumption'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",,0.0531962,,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Coulton', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Giles', 'Affiliation': 'School of Health & Life Sciences, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Grant J', 'Initials': 'GJ', 'LastName': 'McGeechan', 'Affiliation': 'Centre for Applied Psychological Science, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Deluca', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College, London, UK.""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Drummond', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College, London, UK.""}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Howel', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McGovern', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Sumnall', 'Affiliation': 'Faculty of Health, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Albani', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Sadie', 'Initials': 'S', 'LastName': 'Boniface', 'Affiliation': 'Institute of Alcohol Studies, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ferguson', 'Affiliation': 'School of Social Sciences, Humanities & Law, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Eilish', 'Initials': 'E', 'LastName': 'Gilvarry', 'Affiliation': 'Northumberland, Tyne & Wear NHS Foundation Trust, St Nicholas Hospital, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Hendrie', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Howe', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Ramsay', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College, London, UK.""}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Newbury-Birch', 'Affiliation': 'School of Social Sciences, Humanities & Law, Teesside University, Middlesbrough, UK.'}]","Alcohol and alcoholism (Oxford, Oxfordshire)",['10.1093/alcalc/agab087']
1959,35134489,The efficacy of henna (Lawsonia inermis L.) mouthwash versus chlorhexidine gluconate 0.2% mouthwash as adjuvant therapy of oral lichen planus: A randomized double-blind clinical trial.,"ETHNOPHARMACOLOGICAL RELEVANCE


In modern medicine, some traditional remedies are introduced to be effective in treatment. Accordingly, the henna plant (Lawsonia inermis L.) is studied more than before. Previous studies have shown many medical properties for henna, such as anti-inflammatory and anti-fungal properties.
AIM OF THE STUDY


Oral lichen planus (OLP) is a common mucocutaneous disease with chronic immunomodulatory disruptions. Topical corticosteroids are the first line of OLP treatment. Previous studies have suggested different adjunctive therapies for preventing the side effects of corticosteroids overuse. This study aimed to compare the effects of henna and chlorhexidine mouthwashes as adjunctive therapy.
MATERIALS AND METHODS


This parallel-group, double-blind, randomized controlled study was conducted on forty OLP patients. Luteolin content was determined in Henna mouthwash composed of 2% aqueous extract of henna, 2% ethanol, 10% glycerol, and 0.1% methylparaben distilled water. Henna or chlorhexidine mouthwashes were prescribed twice daily as an adjuvant to the topical corticosteroid treatment. Visual analog scale (VAS) index and Thongprasom rating were used to measure pain intensity and clinical signs of patients at days 0,7, and 14. The collected data were analyzed using SPSS software (version 26.0; SPSS). Ordinal logistic regression was used to investigate the effect of independent variables on Thongprasom and VAS scores.
RESULTS


In this clinical trial, 82.6% of the participants were women. There was no difference between the two study groups in terms of VAS scores (p = 0.404) and clinical features (p = 0.305) in the second follow-up visit. All drug regimens caused clinical signs and symptoms relief.
CONCLUSIONS


There was no significant difference between the groups receiving topical corticosteroid supplementation, neither henna mouthwash nor chlorhexidine mouthwash. The therapeutic effects of henna mouthwash in the main or adjuvant treatment of OLP need more evaluation in future research. Henna mouthwash can be a good alternative to chlorhexidine mouthwash if no side effects are reported.",2022,"There was no significant difference between the groups receiving topical corticosteroid supplementation, neither henna mouthwash nor chlorhexidine mouthwash.","['forty OLP patients', 'oral lichen planus']","['ethanol, 10% glycerol, and 0.1% methylparaben distilled water', 'chlorhexidine mouthwashes', 'henna and chlorhexidine mouthwashes', 'henna (Lawsonia inermis L.) mouthwash versus chlorhexidine gluconate', 'Topical corticosteroids', 'chlorhexidine']","['VAS scores', 'clinical signs and symptoms relief', 'Visual analog scale (VAS) index and Thongprasom rating']","[{'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0066415', 'cui_str': 'methylparaben'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0352155', 'cui_str': 'Chlorhexidine Mouthwash'}, {'cui': 'C0064698', 'cui_str': 'lawsone'}, {'cui': 'C1068389', 'cui_str': 'Henna Plant'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",40.0,0.206162,"There was no significant difference between the groups receiving topical corticosteroid supplementation, neither henna mouthwash nor chlorhexidine mouthwash.","[{'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Kakoei', 'Affiliation': 'Department of Oral and Maxillofacial Medicine, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: s_kakooie@kum.ac.ir.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Karbasi', 'Affiliation': 'Department of Oral and Maxillofacial Medicine, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: n.karbasi@semums.ac.ir.'}, {'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Raeiszadeh', 'Affiliation': 'Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: m.raeiszadeh@kmu.ac.ir.'}, {'ForeName': 'Haleh', 'Initials': 'H', 'LastName': 'Tajadini', 'Affiliation': 'Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman, Iran; Department of Persian Medicine, School of Persian Medicine, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: H_tajadini@kmu.ac.ir.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Nekouei', 'Affiliation': 'Endodontology Research Center, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: Nekouei.amir@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2022.115037']
1960,35134424,Development and validation of a model to predict acute kidney injury following wasp stings: A multicentre study.,"OBJECTIVE


To establish and validate a model to predict acute kidney injury (AKI) following wasp stings.
METHODS


In this multicentre prospective study, 508 patients with wasp stings from July 2015 to December 2019 were randomly divided into a training set (n = 381) and a validation set (n = 127) for internal and external validation. Risk factors were identified, and a model was established to predict the probability of AKI following multiple wasp stings using an individual nomogram and a predictive formula. The performances of the model were assessed by using the area under the curve (AUC), accuracy (ACC) of the receiver operating characteristic curve and decision curve analysis.
RESULTS


The number of stings, aspartate aminotransferase >147 U/L, lactate dehydrogenase >477 U/L, time from stings to admission >12 h and activated partial thromboplastin time >49 s were demonstrated to be independent risk factors for AKI following wasp stings (all P value < 0.05) and were incorporated into the model. The performances of the model were validated (AUC = 0.950 [95% CI: 0.923 to 0.969], ACC = 0.916 and AUC = 0.953 [95% CI: 0.900 to 0.982], ACC = 0.906 in the training set and validation set, respectively). The predictive formula and the nomogram of the model could be utilized to predict AKI following wasp stings, which have sufficient accuracies, good predictive capabilities and good net benefits.
CONCLUSION


The predictive formula and the individual nomogram of the model might serve as promising predictive tools to assess the probability of AKI following wasp stings.",2022,"The performances of the model were validated (AUC = 0.950 [95% CI: 0.923 to 0.969], ACC = 0.916 and AUC = 0.953 [95% CI: 0.900 to 0.982], ACC = 0.906 in the training set and validation set, respectively).","['acute kidney injury following wasp stings', '508 patients with wasp stings from July 2015 to December 2019']",[],"['number of stings, aspartate aminotransferase >147 U/L, lactate dehydrogenase >477 U/L, time from stings to admission >12\u202fh and activated partial thromboplastin time', 'area under the curve (AUC), accuracy (ACC) of the receiver operating characteristic curve and decision curve analysis']","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0043041', 'cui_str': 'Wasp'}, {'cui': 'C0038340', 'cui_str': 'Sting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038340', 'cui_str': 'Sting'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",508.0,0.03777,"The performances of the model were validated (AUC = 0.950 [95% CI: 0.923 to 0.969], ACC = 0.916 and AUC = 0.953 [95% CI: 0.900 to 0.982], ACC = 0.906 in the training set and validation set, respectively).","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Ying Ying', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Rong Shuang', 'Initials': 'RS', 'LastName': 'Huang', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Bei Bei', 'Initials': 'BB', 'LastName': 'Wang', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, West China Hospital of Sichuan University, Chengdu, China. Electronic address: zhangling_crrt@163.com.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, West China Hospital of Sichuan University, Chengdu, China. Electronic address: fupinghx@163.com.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': ""Division of Nephrology, People's Hospital of Ziyang City, Ziyang, China.""}, {'ForeName': 'Changbin', 'Initials': 'C', 'LastName': 'Liao', 'Affiliation': ""Division of Nephrology, Third People's Hospital of Zigong City, Zigong, China.""}, {'ForeName': 'Dezheng', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Division of Nephrology, People's Hospital of Jianyang City, Jianyang, China.""}, {'ForeName': 'Hen', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': ""Division of Nephrology, People's Hospital of Ya'an, Ya'an, China.""}, {'ForeName': 'Jixian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Division of Nephrology, Renshou People's Hospital, Renshou, China.""}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Bi', 'Affiliation': ""Division of Nephrology, Third People's Hospital of Mianyang City, Mianyang, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Liao', 'Affiliation': ""Division of Nephrology, First People's Hospital of Guangyuan, Guangyuan, China.""}, {'ForeName': 'Zaizhi', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ""Division of Nephrology, People's Hospital of Meishan City, Meishan, China.""}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': ""Division of Nephrology, Zigong First People's Hospital, Yibin, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Division of Nephrology, Zigong City Fourth People's Hospital, Zigong, China.""}, {'ForeName': 'Fangming', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ""Division of Nephrology, Dazhou Second People's Hospital, Dazhou, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Division of Nephrology, Guangyuan Central Hospital, Guangyuan, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Division of Nephrology, Sichuan Armed Police Corps Hospital, Leshan, China.'}, {'ForeName': 'Xisheng', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Division of Nephrology, Nanchong Central Hospital, Nanchong, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Division of Nephrology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Guoyuan', 'Initials': 'G', 'LastName': 'Yao', 'Affiliation': ""Division of Nephrology, Luzhou People's Hospital, Luzhou, China.""}, {'ForeName': 'Wanchao', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Division of Nephrology, Yibin First People's Hospital, Yibin, China.""}, {'ForeName': 'Santao', 'Initials': 'S', 'LastName': 'Ou', 'Affiliation': 'Division of Nephrology, The Affiliated Hospital of Southwest Medical University, Luzhou, China.'}, {'ForeName': 'Deqiong', 'Initials': 'D', 'LastName': 'Xie', 'Affiliation': ""Division of Nephrology, Yibin Second People's Hospital, Yibin, China.""}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Division of Nephrology, Chengdu Second People's Hospital, Chengdu, China.""}, {'ForeName': 'Linfeng', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Division of Nephrology, Dujiangyan People's Hospital, Dujiangyan, China.""}, {'ForeName': 'Yinlong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Division of Nephrology, Guangxi People's Hospital, Guangyuan, China.""}]",Toxicon : official journal of the International Society on Toxinology,['10.1016/j.toxicon.2022.02.003']
1961,35146830,"The impact of incisional negative pressure wound therapy on scar quality and patient-reported outcomes: A within-patient-controlled, randomised trial.","Literature provides a moderate level of evidence for the beneficial effects of incisional negative pressure wound therapy (iNPWT) on scar quality. The purpose of this study was to establish if iNPWT results in improved scar outcomes in comparison to the standard of care. Therefore, a within-patient randomised controlled, open-label trial was conducted in transgender men undergoing gender-affirming mastectomies. A unilateral side was randomised to receive iNPWT (PICO™, Smith&Nephew) without suction drains and contrastingly the standard dressing (Steri-Strips™) with suction drain. Scar quality and questionnaires were bilaterally measured by means of objective assessments and patient-reported outcome measures (PROM) at 1, 3 and 12 months. Objective scar outcomes were scar pliability (Cutometer®), colouration (DSM-II) and scar width (3-D imaging). PROM outcomes were related to scars (POSAS and SCAR-Q) and body satisfaction (BODY-Q). From 85 included patients, 80 were included for analyses. No significant difference between treatments was seen in the quantitative outcomes of scar pliability, colour, and width. For qualitative scar outcomes, several significant findings for iNPWT were found for several subscales of the POSAS, SCAR-Q, and BODY-Q. These effects could not be substantiated with linear mixed-model regression, signifying no statically more favourable outcome for either treatment option. In conclusion, this study demonstrated that some PROM outcomes were more favourable for the iNPWT compared to standard treatment. In contrast, the quantitative outcomes showed no beneficial effects of iNPWT on scar outcomes. This suggests that iNPWT is of little benefit as a scar-improving therapy.",2022,PROM outcomes were related to scars (POSAS and SCAR-Q) and body satisfaction (BODY-Q).,"['transgender men undergoing gender-affirming mastectomies', 'From 85 included patients, 80 were included for analyses']","['iNPWT (PICO™, Smith&Nephew) without suction drains and contrastingly the standard dressing (Steri-Strips™) with suction drain', 'iNPWT', 'incisional negative pressure wound therapy (iNPWT', 'Incisional Negative Pressure Wound']","['Scar quality and questionnaires', 'scar pliability (Cutometer®), coloration (DSM-II), and scar width (3-D imaging', 'several subscales of the POSAS, SCAR-Q, and BODY-Q', 'scar quality', 'PROM outcomes', 'scars (POSAS and SCAR-Q) and body satisfaction (BODY-Q', 'quantitative outcomes of scar pliability, color, and width', 'scar outcomes', 'Scar Quality']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0441139', 'cui_str': 'Suction drain'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0950000', 'cui_str': 'Silene'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1137104', 'cui_str': 'DSM-II'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0887832', 'cui_str': '3-D Imaging'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",85.0,0.0583724,PROM outcomes were related to scars (POSAS and SCAR-Q) and body satisfaction (BODY-Q).,"[{'ForeName': 'Floyd W', 'Initials': 'FW', 'LastName': 'Timmermans', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Amsterdam Movement Sciences, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Sterre E', 'Initials': 'SE', 'LastName': 'Mokken', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Amsterdam Movement Sciences, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan-Maerten', 'Initials': 'JM', 'LastName': 'Smit', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Amsterdam Movement Sciences, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Mark-Bram', 'Initials': 'MB', 'LastName': 'Bouman', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Amsterdam Movement Sciences, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Timotheus C', 'Initials': 'TC', 'LastName': 'van de Grift', 'Affiliation': 'Center of Expertise on Gender Dysphoria, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Margriet G', 'Initials': 'MG', 'LastName': 'Mullender', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Amsterdam Movement Sciences, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Middelkoop', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Amsterdam Movement Sciences, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.13001']
1962,35147724,L-DOPA administration shifts the stability-flexibility balance towards attentional capture by distractors during a visual search task.,"RATIONALE


The cognitive control dilemma describes the necessity to balance two antagonistic modes of attention: stability and flexibility. Stability refers to goal-directed thought, feeling, or action and flexibility refers to the complementary ability to adapt to an ever-changing environment. Their balance is thought to be maintained by neurotransmitters such as dopamine, most likely in a U-shaped rather than linear manner. However, in humans, studies on the stability-flexibility balance using a dopaminergic agent and/or measurement of brain dopamine are scarce.
OBJECTIVE


The study aimed to investigate the causal involvement of dopamine in the stability-flexibility balance and the nature of this relationship in humans.
METHODS


Distractibility was assessed as the difference in reaction time (RT) between distractor and non-distractor trials in a visual search task. In a randomized, placebo-controlled, double-blind, crossover study, 65 healthy participants performed the task under placebo and a dopamine precursor (L-DOPA). Using  18 F-DOPA-PET, dopamine availability in the striatum was examined at baseline to investigate its relationship to the RT distractor effect and to the L-DOPA-induced change of the RT distractor effect.
RESULTS


There was a pronounced RT distractor effect in the placebo session that increased under L-DOPA. Neither the RT distractor effect in the placebo session nor the magnitude of its L-DOPA-induced increase were related to baseline striatal dopamine.
CONCLUSIONS


L-DOPA administration shifted the stability-flexibility balance towards attentional capture by distractors, suggesting causal involvement of dopamine. This finding is consistent with current theories of prefrontal cortex dopamine function. Current data can neither confirm nor falsify the inverted U-shaped function hypothesis with regard to cognitive control.",2022,"Neither the RT distractor effect in the placebo session nor the magnitude of its L-DOPA-induced increase were related to baseline striatal dopamine.
","['65 healthy participants performed the task under', 'humans']","['placebo', 'dopamine', 'placebo and a dopamine precursor (L-DOPA']","['stability-flexibility balance towards attentional capture', 'RT distractor effect', 'reaction time (RT', 'magnitude of its L-DOPA', 'L-DOPA']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}]",65.0,0.163203,"Neither the RT distractor effect in the placebo session nor the magnitude of its L-DOPA-induced increase were related to baseline striatal dopamine.
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Riedel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Domachowska', 'Affiliation': 'Department of Psychology, Technische Universität Dresden, Zellescher Weg 17, 01069, Dresden, Germany.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Neukam', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tönges', 'Affiliation': 'Department of Neurology, Ruhr University Bochum, St. Josef-Hospital, Gudrunstraße 56, 44791, Bochum, Germany.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Li', 'Affiliation': 'Department of Psychology, Technische Universität Dresden, Zellescher Weg 17, 01069, Dresden, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Goschke', 'Affiliation': 'Department of Psychology, Technische Universität Dresden, Zellescher Weg 17, 01069, Dresden, Germany.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Smolka', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany. michael.smolka@tu-dresden.de.'}]",Psychopharmacology,['10.1007/s00213-022-06077-w']
1963,35148419,Randomized trial of individual reminiscence therapy for older adults with cognitive impairment: a 3-month responder analysis.,"INTRODUCTION


Non-pharmacological intervention options, including individual reminiscence therapy (iRT), have been effective in improving cognitive functioning, mood, and quality of life (QoL) in persons with neurocognitive disorders (NCD).
OBJECTIVES


A 13-week randomized trial intervention utilizing iRT was conducted on older adults with NCD. We explored predictors of participants with positive and non-positive intervention responses using responder analysis, an analytic strategy that focuses on contributors to intervention response.
PATIENTS AND METHODS


Re-analysis of a published single-blind, multicentre, randomised controlled trial on 251 older adult residents with NCD from residential facilities across Portugal. Participants received 13 weeks of biweekly iRT (26 sessions) or treatment/programming as usual. Outcomes included global cognition (Minimental State Examination), memory (MAT), executive functioning (FAB), depressive symptoms (GDS-15), and QoL (QoL-AD).
RESULTS


There were more responders in the intervention than the control group on all five criteria, with significant differences for cognition (p = 0.001; f = 0.202; NNT = 5) and memory (p = 0.004; f = 0.184; NNT = 6). At baseline, intervention responders vs non-responders had: higher QoL-AD scores (30.23 vs 25.57; p < 0.001; d = -0.774) for cognition; lower FAB scores (1.41 vs -2.12; p < 0.001; d = 0.928) for executive functioning; higher GDS-15 scores for the depressive symptoms (7.57 vs 4.91; p < 0.001; d = -0.845), and for QoL (6.81 vs 5.33; p = 0.013; d = -0.443).
CONCLUSIONS


The iRT intervention showed high response rates for cognition and memory. Those with worse executive dysfunction, mood, and QoL, benefitted most from the intervention for those respective outcomes. Therefore, the presented iRT has beneficial effects for people with NCD, with mood and QoL as important influential factors.",2022,"There were more responders in the intervention than the control group on all five criteria, with significant differences for cognition (p = 0.001; f = 0.202; NNT = 5) and memory (p = 0.004; f = 0.184; NNT = 6).","['participants with positive and non-positive intervention responses', 'persons with neurocognitive disorders (NCD', 'older adults with cognitive impairment', '251 older adult residents with NCD from residential facilities across Portugal', 'older adults with NCD']","['individual reminiscence therapy (iRT', 'individual reminiscence therapy', 'iRT intervention']","['higher QoL-AD scores', 'cognitive functioning, mood, and quality of life (QoL', 'response rates for cognition and memory', 'GDS-15 scores for the depressive symptoms', 'global cognition (Minimental State Examination), memory (MAT), executive functioning (FAB), depressive symptoms (GDS-15), and QoL (QoL-AD', 'FAB scores']","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150321', 'cui_str': 'Reminiscence therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0021031', 'cui_str': 'Immunoglobulin, F(ab) fragment'}]",251.0,0.1385,"There were more responders in the intervention than the control group on all five criteria, with significant differences for cognition (p = 0.001; f = 0.202; NNT = 5) and memory (p = 0.004; f = 0.184; NNT = 6).","[{'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Justo-Henriques', 'Affiliation': 'Nursing School of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Carvalho', 'Affiliation': 'Bridgewater State University, Bridgewater, MA, EE.UU.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pérez-Sáez', 'Affiliation': 'CRE de atención a personas con enfermedad de Alzheimer y otras demenci, Salamanca, España.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Neves', 'Affiliation': 'Nursing School of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Parola', 'Affiliation': 'Nursing School of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Alves-Apóstolo', 'Affiliation': 'Nursing School of Coimbra, Coimbra, Portugal.'}]",Revista de neurologia,['10.33588/rn.7404.2021322']
1964,35149574,Improving effective contraception uptake through provision of bridging contraception within community pharmacies: findings from the Bridge-it Study process evaluation.,"OBJECTIVE


To present process evaluation results from the Bridge-it Study, a pragmatic cluster randomised cross-over trial to improve effective contraception uptake through provision of the progestogen only pill (POP) plus sexual and reproductive health (SRH) clinic rapid-access to women presenting to community pharmacies for emergency contraception (EC).
RESEARCH DESIGN AND METHODS


A multimethod process evaluation was conducted to assess intervention implementation, mechanisms of change and contextual factors. Data were gathered from screening logs (n=599), observations of pharmacist training, analysis of data from 4-month follow-up questionnaires (n=406), monitoring of contemporaneous events and qualitative interviews with 22 pharmacists, 5 SRH clinical staff and 36 study participants in three participating UK sites in Lothian, Tayside and London.
RESULTS


The intervention was largely delivered as intended and was acceptable. Pharmacists', SRH clinical staff and participants' accounts highlighted that providing a supply of POP with EC from the pharmacy as routine practice may have positive impacts on contraceptive practices in the short term, and potentially longer term. Key mechanisms of change included ease of access, increased awareness of contraception and services, and greater motivation and perceptions of self-efficacy. Few participants took up the offer to attend an SRH service (rapid-access component), and existing barriers within the SRH context were apparent (eg, lack of staff). Participant accounts highlight persistent barriers to accessing and using routine effective contraception remain.
CONCLUSIONS


Implementation appeared to be acceptable and feasible, highlighting the potential for provision of POP within EC consultations as routine practice in community pharmacies. However, lack of engagement with the rapid access component of the intervention and existing barriers within the SRH context suggest that signposting to SRH services may be sufficient. Wider implementation should consider ways to address key implementation challenges to increase effectiveness and sustainability, and to overcome persistent barriers to accessing and using effective contraception.
TRIAL REGISTRATION NUMBER


ISRCTN70616901.",2022,"Key mechanisms of change included ease of access, increased awareness of contraception and services, and greater motivation and perceptions of self-efficacy.","['22 pharmacists, 5 SRH clinical staff and 36 study participants in three participating UK sites in Lothian, Tayside and London', 'community pharmacies', 'women presenting to community pharmacies for emergency contraception (EC']",['progestogen only pill (POP) plus sexual and reproductive health (SRH) clinic rapid-access'],"['awareness of contraception and services, and greater motivation and perceptions of self-efficacy']","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454912', 'cui_str': 'Lothian'}, {'cui': 'C0454914', 'cui_str': 'Tayside'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0558252', 'cui_str': 'Emergency contraception'}]","[{'cui': 'C0420857', 'cui_str': 'Progestogen only oral contraceptive'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.046797,"Key mechanisms of change included ease of access, increased awareness of contraception and services, and greater motivation and perceptions of self-efficacy.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Patterson', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK susan.patterson@glasgow.ac.uk.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McDaid', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Saunders', 'Affiliation': 'School of Social and Political Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Battison', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Glasier', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Radley', 'Affiliation': 'Directorate of Public Health, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Stephenson', 'Affiliation': ""Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Johnstone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Morelli', 'Affiliation': ""King's College Hospital and King's Centre for Global Health and Health Partnerships, King's College London, London, UK.""}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Sally', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Stewart', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Sharon Tracey', 'Initials': 'ST', 'LastName': 'Cameron', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK.'}]",BMJ open,['10.1136/bmjopen-2021-057348']
1965,35149571,TACTICS - Trial of Advanced CT Imaging and Combined Education Support for Drip and Ship: evaluating the effectiveness of an 'implementation intervention' in providing better patient access to reperfusion therapies: protocol for a non-randomised controlled stepped wedge cluster trial in acute stroke.,"INTRODUCTION


Stroke reperfusion therapies, comprising intravenous thrombolysis (IVT) and/or endovascular thrombectomy (EVT), are best practice treatments for eligible acute ischemic stroke patients. In Australia, EVT is provided at few, mainly metropolitan, comprehensive stroke centres (CSC). There are significant challenges for Australia's rural and remote populations in accessing EVT, but improved access can be facilitated by a 'drip and ship' approach. TACTICS (Trial of Advanced CT Imaging and Combined Education Support for Drip and Ship) aims to test whether a multicomponent, multidisciplinary implementation intervention can increase the proportion of stroke patients receiving EVT.
METHODS AND ANALYSIS


This is a non-randomised controlled, stepped wedge trial involving six clusters across three Australian states. Each cluster comprises one CSC hub and a minimum of three primary stroke centre (PSC) spokes. Hospitals will work in a hub and spoke model of care with access to a multislice CT scanner and CT perfusion image processing software (MIStar, Apollo Medical Imaging). The intervention, underpinned by behavioural theory and technical assistance, will be allocated sequentially, and clusters will move from the preintervention (control) period to the postintervention period.
PRIMARY OUTCOME


Proportion of all stroke patients receiving EVT, accounting for clustering.
SECONDARY OUTCOMES


Proportion of patients receiving IVT at PSCs, proportion of treated patients (IVT and/or EVT) with good (modified Rankin Scale (mRS) score 0-2) or poor (mRS score 5-6) functional outcomes and European Quality of Life Scale scores 3 months postintervention, proportion of EVT-treated patients with symptomatic haemorrhage, and proportion of reperfusion therapy-treated patients with good versus poor outcome who presented with large vessel occlusion at spokes.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from the Hunter New England Human Research Ethics Committee (18/09/19/4.13, HREC/18/HNE/241, 2019/ETH01238). Trial results will be disseminated widely through published manuscripts, conference presentations and at national and international platforms regardless of whether the trial was positive or neutral.
TRIAL REGISTRATION NUMBER


ACTRN12619000750189; UTNU1111-1230-4161.",2022,"There are significant challenges for Australia's rural and remote populations in accessing EVT, but improved access can be facilitated by a 'drip and ship' approach.","['eligible acute ischemic stroke patients', 'stroke patients receiving EVT']","['intravenous thrombolysis (IVT) and/or endovascular thrombectomy (EVT', 'Advanced CT Imaging and Combined Education Support for Drip and Ship', 'multicomponent, multidisciplinary implementation intervention', 'TACTICS ']","['IVT at PSCs, proportion of treated patients (IVT and/or EVT) with good (modified Rankin Scale (mRS) score 0-2) or poor (mRS score 5-6) functional outcomes and', 'Proportion of all stroke patients receiving EVT, accounting for clustering', 'European Quality of Life Scale scores']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0452837', 'cui_str': 'Dripping'}, {'cui': 'C0036971', 'cui_str': 'Ship'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C2936598', 'cui_str': 'Pancreatic Stellate Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}]",6.0,0.0863487,"There are significant challenges for Australia's rural and remote populations in accessing EVT, but improved access can be facilitated by a 'drip and ship' approach.","[{'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Ryan', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Cox', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Whalen', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bivard', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Attia', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bladin', 'Affiliation': 'Eastern Health Clinical School, Monash University, Box Hill, Victoria, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Bruce C V', 'Initials': 'BCV', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Parsons', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Rohan S', 'Initials': 'RS', 'LastName': 'Grimley', 'Affiliation': 'Queensland State-wide Stroke Clinical Network, Healthcare Improvement Unit, Queensland Health, Herston, Queensland, Australia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Data Sciences, Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kuhle', 'Affiliation': 'Queensland State-wide Stroke Clinical Network, Healthcare Improvement Unit, Queensland Health, Herston, Queensland, Australia.'}, {'ForeName': 'Frederick R', 'Initials': 'FR', 'LastName': 'Walker', 'Affiliation': 'Centre for Advanced Training Systems, School of Biomedical Sciences and Pharmacy, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Hood', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Maltby', 'Affiliation': 'Centre for Advanced Training Systems, School of Biomedical Sciences and Pharmacy, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Keynes', 'Affiliation': 'Centre for Advanced Training Systems, School of Biomedical Sciences and Pharmacy, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Hatchwell', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Malavera', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Apollo Medical Imaging Technology Pty Ltd, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': ""Royal Brisbane and Women's Hospital, University of Queensland, Brisbane, Queensland, Australia.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Muller', 'Affiliation': 'Queensland State-wide Stroke Clinical Network, Healthcare Improvement Unit, Queensland Health, Herston, Queensland, Australia.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Sabet', 'Affiliation': 'School of Medicine, Griffith University, Southport, Queensland, Australia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Garcia-Esperon', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Spratt', 'Affiliation': 'Division of Medicine, Department of Neurology, John Hunter Hospital, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Butcher', 'Affiliation': 'Department of Neurology, Liverpool Hospital, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia christopher.levi@health.nsw.gov.au.'}]",BMJ open,['10.1136/bmjopen-2021-055461']
1966,35149568,Interprofessional evidence-based counselling programme for complementary and integrative healthcare in patients with cancer: study protocol for the controlled implementation study CCC-Integrativ.,"INTRODUCTION


According to international literature, patients with cancer wish to have information on complementary and integrative healthcare (CIH). Medical guidelines recommend actively approaching patients with cancer discussing potential benefits and risks of individual CIH methods. While some CIH methods, for example, acupuncture and yoga, have been proven effective in high-quality studies, other CIH methods lack studies or bear the risk of interactions with chemotherapeutics, for example, herbal drugs. Therefore, an evidence-based interprofessional counselling programme on CIH will be implemented at four Comprehensive Cancer Centres in the federal state of Baden-Wuerttemberg, Germany.
METHODS AND ANALYSIS


A complex intervention consisting of elements on patient, provider and system levels will be developed and evaluated within a multilayer evaluation design with confirmatory evaluation on patient level. Patients with a cancer diagnosis within the last 6 months will receive three individual counselling sessions on CIH within 3 months (=intervention on patient level). The counselling will be provided by an interprofessional team of medical and nursing staff. For this purpose, an intensive online training programme, a CIH knowledge database and an interprofessional team-building process were developed and implemented (=intervention on provider level). Moreover, training events on the basics of CIH are offered in the outpatient setting (=intervention on system level). Primary outcome of the evaluation at the patient level is patient activation measured (PAM) with the PAM-13 after 3 months. Secondary outcomes, for example, quality of life, self-efficacy and clinical parameters, will be assessed at baseline, after 3 months and at 6 months follow-up. The intervention group (n=1000) will be compared with a control group (n=500, treatment as usual, no CIH counselling. The outcomes and follow-up times in the control group are the same as in the intervention group. Moreover, the use of health services will be analysed in both groups using routine data. A qualitative-quantitative process evaluation as well as a health economic evaluation will identify relevant barriers and enabling factors for later roll-out.
ETHICS AND DISSEMINATION


The study has been approved by the appropriate Institutional Ethical Committee of the University of Tuebingen, No. 658/2019BO1. The results of these studies will be disseminated to academic audiences and in the community.
TRIAL REGISTRATION NUMBER


DRKS00021779; Pre-results.",2022,The outcomes and follow-up times in the control group are the same as in the intervention group.,"['patients with cancer wish to have information on complementary and integrative healthcare (CIH', 'Patients with a cancer diagnosis within the last 6 months', 'patients with cancer']","['Interprofessional evidence-based counselling programme', 'control group (n=500, treatment as usual, no CIH counselling']","['example, quality of life, self-efficacy and clinical parameters', 'evaluation at the patient level is patient activation measured (PAM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C2931826', 'cui_str': 'Potassium aggravated myotonia'}]",1000.0,0.0655061,The outcomes and follow-up times in the control group are the same as in the intervention group.,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Valentini', 'Affiliation': 'Institute for General Practice and Interprofessional Care, University Hospital Tübingen, Tübingen, Germany jan.valentini@med.uni-tuebingen.de.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Fröhlich', 'Affiliation': 'Institute for General Practice and Interprofessional Care, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Stolz', 'Affiliation': 'Institute for General Practice and Interprofessional Care, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Mahler', 'Affiliation': 'Institute for Health Sciences, Department of Nursing Science, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Institute for Clinical Epidemiology and Applied Biostatistics, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Klafke', 'Affiliation': 'Department of General Practice and Health Services Reseach, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Horneber', 'Affiliation': 'Department of Internal Medicine, Division of Pneumology, Paracelsus Medical University, Klinikum Nurnberg, Nurnberg, Germany.'}, {'ForeName': 'Jona', 'Initials': 'J', 'LastName': 'Frasch', 'Affiliation': 'aQua Institute for Applied Quality Improvement and Research in Health Care, Goettingen, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kramer', 'Affiliation': 'Department of Integrative Medicine, Faculty of Medicine, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Bertz', 'Affiliation': 'Department of Medicine I, Faculty of Medicine, University Hospital Freiburg, Freiburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Grün', 'Affiliation': 'Department of Medical Oncology, National Centre for Tumor Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Tomaschko-Ubeländer', 'Affiliation': 'Fachbereich Integriertes Leistungsmanagement, AOK Baden-Württemberg, Stuttgart, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Joos', 'Affiliation': 'Institute for General Practice and Interprofessional Care, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2021-055076']
1967,35152152,"Randomised controlled trial of intravenous nafamostat mesylate in COVID pneumonitis: Phase 1b/2a experimental study to investigate safety, Pharmacokinetics and Pharmacodynamics.","BACKGROUND


Many repurposed drugs have progressed rapidly to Phase 2 and 3 trials in COVID19 without characterisation of Pharmacokinetics /Pharmacodynamics including safety data. One such drug is nafamostat mesylate.
METHODS


We present the findings of a phase Ib/IIa open label, platform randomised controlled trial of intravenous nafamostat in hospitalised patients with confirmed COVID-19 pneumonitis. Patients were assigned randomly to standard of care (SoC), nafamostat or an alternative therapy. Nafamostat was administered as an intravenous infusion at a dose of 0.2 mg/kg/h for a maximum of seven days. The analysis population included those who received any dose of the trial drug and all patients randomised to SoC. The primary outcomes of our trial were the safety and tolerability of intravenous nafamostat as an add on therapy for patients hospitalised with COVID-19 pneumonitis.
FINDINGS


Data is reported from 42 patients, 21 of which were randomly assigned to receive intravenous nafamostat. 86% of nafamostat-treated patients experienced at least one AE compared to 57% of the SoC group. The nafamostat group were significantly more likely to experience at least one AE (posterior mean odds ratio 5.17, 95% credible interval (CI) 1.10 - 26.05) and developed significantly higher plasma creatinine levels (posterior mean difference 10.57 micromol/L, 95% CI 2.43-18.92). An average longer hospital stay was observed in nafamostat patients, alongside a lower rate of oxygen free days (rate ratio 0.55-95% CI 0.31-0.99, respectively). There were no other statistically significant differences in endpoints between nafamostat and SoC. PK data demonstrated that intravenous nafamostat was rapidly broken down to inactive metabolites. We observed no significant anticoagulant effects in thromboelastometry.
INTERPRETATION


In hospitalised patients with COVID-19, we did not observe evidence of anti-inflammatory, anticoagulant or antiviral activity with intravenous nafamostat, and there were additional adverse events.
FUNDING


DEFINE was funded by LifeArc (an independent medical research charity) under the STOPCOVID award to the University of Edinburgh. We also thank the Oxford University COVID-19 Research Response Fund (BRD00230).",2022,"The nafamostat group were significantly more likely to experience at least one AE (posterior mean odds ratio 5.17, 95% credible interval (CI) 1.10 - 26.05) and developed significantly higher plasma creatinine levels (posterior mean difference 10.57 micromol/L, 95% CI 2.43-18.92).","['hospitalised patients with confirmed COVID-19 pneumonitis', '42 patients, 21 of which', 'was funded by LifeArc (an independent medical research charity) under the STOPCOVID award to the University of Edinburgh', 'COVID pneumonitis', 'patients hospitalised with COVID-19 pneumonitis']","['intravenous nafamostat', 'SoC', 'standard of care (SoC), nafamostat or an alternative therapy', 'intravenous nafamostat mesylate']","['safety and tolerability of intravenous nafamostat', 'average longer hospital stay', 'safety, Pharmacokinetics and Pharmacodynamics', 'plasma creatinine levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0007962', 'cui_str': 'Charities'}, {'cui': 'C0004446', 'cui_str': 'Awards'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0207683', 'cui_str': 'nafamostat'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0207682', 'cui_str': 'nafamostat mesilate'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0207683', 'cui_str': 'nafamostat'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1278055', 'cui_str': 'Plasma creatinine measurement'}]",,0.300316,"The nafamostat group were significantly more likely to experience at least one AE (posterior mean odds ratio 5.17, 95% credible interval (CI) 1.10 - 26.05) and developed significantly higher plasma creatinine levels (posterior mean difference 10.57 micromol/L, 95% CI 2.43-18.92).","[{'ForeName': 'Tom M', 'Initials': 'TM', 'LastName': 'Quinn', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK; Royal Infirmary of Edinburgh, BioQuarter, Little France, Edinburgh.""}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Gaughan', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK; Royal Infirmary of Edinburgh, BioQuarter, Little France, Edinburgh.""}, {'ForeName': 'Annya', 'Initials': 'A', 'LastName': 'Bruce', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Antonelli', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': ""O'Connor"", 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McNamara', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Koch', 'Affiliation': 'Regional Infectious Disease Unit, NHS Lothian, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'MacKintosh', 'Affiliation': 'Regional Infectious Disease Unit, NHS Lothian, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dockrell', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK; Regional Infectious Disease Unit, NHS Lothian, UK.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK; Royal Infirmary of Edinburgh, BioQuarter, Little France, Edinburgh.""}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Blyth', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Church', 'Affiliation': 'Department of Respiratory Medicine, Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde Health Board, Glasgow, UK.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schwarze', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Boz', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Asta', 'Initials': 'A', 'LastName': 'Valanciute', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Burgess', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Emanuel', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Mills', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Rinaldi', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Hardisty', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Mills', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Emily Gwyer', 'Initials': 'EG', 'LastName': 'Findlay', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Jabbal', 'Affiliation': 'Royal Infirmary of Edinburgh, BioQuarter, Little France, Edinburgh.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Duncan', 'Affiliation': 'Regional Infectious Disease Unit, NHS Lothian, UK.'}, {'ForeName': 'Sinéad', 'Initials': 'S', 'LastName': 'Plant', 'Affiliation': 'Regional Infectious Disease Unit, NHS Lothian, UK.'}, {'ForeName': 'Adam D L', 'Initials': 'ADL', 'LastName': 'Marshall', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK; Royal Infirmary of Edinburgh, BioQuarter, Little France, Edinburgh.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Young', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Russell', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Scholefield', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Alastair F', 'Initials': 'AF', 'LastName': 'Nimmo', 'Affiliation': 'Royal Infirmary of Edinburgh, BioQuarter, Little France, Edinburgh.'}, {'ForeName': 'Islom B', 'Initials': 'IB', 'LastName': 'Nazarov', 'Affiliation': 'Latus Therapeutics, Oxford, UK; Department of Pharmacology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Grant C', 'Initials': 'GC', 'LastName': 'Churchill', 'Affiliation': 'Department of Pharmacology, University of Oxford, Oxford, UK.'}, {'ForeName': 'James S O', 'Initials': 'JSO', 'LastName': 'McCullagh', 'Affiliation': 'Department of Chemistry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kourosh H', 'Initials': 'KH', 'LastName': 'Ebrahimi', 'Affiliation': ""Institute of Pharmaceutical Science, King's College London, UK.""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Ferrett', 'Affiliation': 'Department of Radiology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Templeton', 'Affiliation': 'Royal Infirmary of Edinburgh, BioQuarter, Little France, Edinburgh.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Rannard', 'Affiliation': 'Centre of Excellence for Long-acting Therapeutics, Materials Innovation Factory and Department of Pharmacology and Therapeutics, University of Liverpool, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Owen', 'Affiliation': 'Centre of Excellence for Long-acting Therapeutics, Materials Innovation Factory and Department of Pharmacology and Therapeutics, University of Liverpool, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Moore', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Finlayson', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Shankar-Hari', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': ""Centre for Cardiovascular Science, Queen's Medical Research Institute, Bioquarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Parker', 'Affiliation': 'Edinburgh Clinical Trials Unit (ECTU), Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ahsan R', 'Initials': 'AR', 'LastName': 'Akram', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK; Royal Infirmary of Edinburgh, BioQuarter, Little France, Edinburgh.""}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Anthony', 'Affiliation': 'Department of Pharmacology, University of Oxford, Oxford, UK.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Dear', 'Affiliation': ""Royal Infirmary of Edinburgh, BioQuarter, Little France, Edinburgh,; Centre for Cardiovascular Science, Queen's Medical Research Institute, Bioquarter, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Nik', 'Initials': 'N', 'LastName': 'Hirani', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK; Royal Infirmary of Edinburgh, BioQuarter, Little France, Edinburgh.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Dhaliwal', 'Affiliation': ""Centre for Inflammation Research, Queen's Medical Research Institute, BioQuarter, University of Edinburgh, Edinburgh, UK; Royal Infirmary of Edinburgh, BioQuarter, Little France, Edinburgh,. Electronic address: Kev.Dhaliwal@ed.ac.uk.""}]",EBioMedicine,['10.1016/j.ebiom.2022.103856']
1968,34874818,Rapid Phospholipid Turnover after Surfactant Nebulization in Severe COVID-19 Infection: A Randomized Clinical Trial.,,2022,,['Severe COVID-19 Infection'],[],[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",[],[],,0.300167,,"[{'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Postle', 'Affiliation': 'University of Southampton Southampton, United Kingdom.'}, {'ForeName': 'Howard W', 'Initials': 'HW', 'LastName': 'Clark', 'Affiliation': 'University College London Hospital London, United Kingdom.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Fink', 'Affiliation': 'Aerogen Pharma Corporation San Mateo, California.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Madsen', 'Affiliation': 'University College London London, United Kingdom.'}, {'ForeName': 'Grielof', 'Initials': 'G', 'LastName': 'Koster', 'Affiliation': 'University Hospital Southampton National Health System Foundation Trust Southampton, United Kingdom.'}, {'ForeName': 'Madhuriben', 'Initials': 'M', 'LastName': 'Panchal', 'Affiliation': 'University Hospital Southampton National Health System Foundation Trust Southampton, United Kingdom.'}, {'ForeName': 'Ratko', 'Initials': 'R', 'LastName': 'Djukanovic', 'Affiliation': 'University of Southampton Southampton, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brealey', 'Affiliation': 'University College Hospitals London London, United Kingdom.'}, {'ForeName': 'Michael P W', 'Initials': 'MPW', 'LastName': 'Grocott', 'Affiliation': 'University of Southampton Southampton, United Kingdom.'}, {'ForeName': 'Ahilanandan', 'Initials': 'A', 'LastName': 'Dushianthan', 'Affiliation': 'University Hospital Southampton National Health System Foundation Trust Southampton, United Kingdom.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202110-2279LE']
1969,34871098,Early Bactericidal Activity of Delpazolid (LCB01-0371) in Patients with Pulmonary Tuberculosis.,"Delpazolid, an oxazolidinone, has been studied in non-clinical studies of efficacy and toxicity and Phase 1 clinical studies. Delpazolid has  in vitro  activity against Gram-positive bacteria, including Mycobacterium tuberculosis. This study evaluated the bactericidal activity, safety, and pharmacokinetics of delpazolid in patients with pulmonary tuberculosis (TB). Seventy-nine subjects, aged 19 to 75 years with newly diagnosed smear-positive TB with no prior treatment for the current episode and no confirmed resistance to rifampin or isoniazid, were randomized to receive delpazolid 800 mg once a day (QD), 400 mg twice a day (BID), 800 mg BID or 1,200 mg QD or an active control of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) or linezolid 600 mg BID. The primary endpoint was the average daily reduction in log transformed bacterial load, assessed on 7H11 solid-media culture, from days 0 to 14. The average daily decline in log-CFU was 0.044 ± 0.016, 0.053 ± 0.017, 0.043 ± 0.016, and 0.019 ± 0.017, for the delpazolid 800 mg QD, 400 mg BID, 800 mg BID, and the 1,200 mg QD groups, respectively. The average daily decline in log-CFU was 0.192 ± 0.028 for the HRZE group and 0.154 ± 0.023 for the linezolid 600 mg BID group. Three serious adverse events (SAE) were reported, one each in the delpazolid 400 mg BID group (death due to worsening of TB at day 2), the HRZE group (hospitalization due to pleural effusion) and the linezolid group (hyperkalemia); none of the SAEs were assessed as related to study drugs. This study has been registered at ClinicalTrials.gov with registration number NCT02836483.",2022,"The average daily decline in log-CFU was 0.044 ± 0.016, 0.053 ± 0.017, 0.043 ± 0.016, and 0.019 ± 0.017, for the delpazolid 800 mg QD, 400 mg BID, 800 mg BID, and the 1,200 mg QD groups, respectively.","['Patients with Pulmonary Tuberculosis', 'patients with pulmonary tuberculosis (TB', 'Seventy-nine subjects, aged 19 to 75\u2009years with newly diagnosed smear-positive TB with no prior treatment for the current episode and no confirmed resistance to rifampin or isoniazid']","['delpazolid 800\u2009mg once a day (QD', 'Delpazolid (LCB01-0371', 'active control of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) or linezolid 600\u2009mg BID', 'oxazolidinone', 'HRZE', 'linezolid']","['serious adverse events (SAE', 'bactericidal activity, safety, and pharmacokinetics of delpazolid', 'average daily reduction in log transformed bacterial load, assessed on 7H11 solid-media culture']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}]","[{'cui': 'C4705585', 'cui_str': 'delpazolid'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4519303', 'cui_str': 'LCB01-0371'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C1127473', 'cui_str': 'linezolid 600 MG'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0887953', 'cui_str': 'Oxazolidinone'}, {'cui': 'C0663241', 'cui_str': 'linezolid'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0544570', 'cui_str': 'Bactericidal activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4705585', 'cui_str': 'delpazolid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]",,0.125465,"The average daily decline in log-CFU was 0.044 ± 0.016, 0.053 ± 0.017, 0.043 ± 0.016, and 0.019 ± 0.017, for the delpazolid 800 mg QD, 400 mg BID, 800 mg BID, and the 1,200 mg QD groups, respectively.","[{'ForeName': 'Ju Sang', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Yong-Hyun', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': ""Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Sang Haak', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': ""Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Yee Hyung', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Pulmonary, Allergy and Critical Care Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University, Seoul, South Korea.'}, {'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': ""Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Kang', 'Affiliation': ""Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Sung Kyoung', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': ""Division of Pulmonology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, South Korea.""}, {'ForeName': 'Seung Joon', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': ""Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Yun-Seong', 'Initials': 'YS', 'LastName': 'Kang', 'Affiliation': 'Division of Pulmonology and Critical Care Medicine, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, Goyang, South Korea.'}, {'ForeName': 'Tae-Hyung', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Guri, South Korea.'}, {'ForeName': 'Jeongha', 'Initials': 'J', 'LastName': 'Mok', 'Affiliation': 'Department of Internal Medicine, Pusan National University Hospital, Busan, South Korea.'}, {'ForeName': 'Min Kwang', 'Initials': 'MK', 'LastName': 'Byun', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Gangnam-gu, Seoul, South Korea.'}, {'ForeName': 'Hye Jung', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Gangnam-gu, Seoul, South Korea.'}, {'ForeName': 'Joon-Sung', 'Initials': 'JS', 'LastName': 'Joh', 'Affiliation': 'Department of Internal Medicine, National Medical Center, Seoul, South Korea.'}, {'ForeName': 'Yong Bum', 'Initials': 'YB', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Hallym University Medical Center, Kangdong Sacred Heart Hospital, Seoul, South Korea.'}, {'ForeName': 'Hyeong-Seok', 'Initials': 'HS', 'LastName': 'Lim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hongjo', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Department of Preventive Medicine, Konyang University College of Medicine, Daejon, South Korea.'}, {'ForeName': 'Seung Heon', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'The Korean Institute of Tuberculosis, Cheongju, South Korea.'}, {'ForeName': 'Hyejin', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'The Korean Institute of Tuberculosis, Cheongju, South Korea.'}, {'ForeName': 'Jeongseong', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'The Korean Institute of Tuberculosis, Cheongju, South Korea.'}, {'ForeName': 'Hyunji', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'The Korean Institute of Tuberculosis, Cheongju, South Korea.'}, {'ForeName': 'Xianlin', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Merlin Clinical Service, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Alsultan', 'Affiliation': 'Clinical Pharmacy, Department College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'InSook', 'Initials': 'I', 'LastName': 'Cho', 'Affiliation': 'LegoChem BioSciences, Seoul, South Korea.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Geiter', 'Affiliation': 'Consultant, Sunny Isles Beach, Florida, USA.'}, {'ForeName': 'Tae Sun', 'Initials': 'TS', 'LastName': 'Shim', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01684-21']
1970,35131846,Reductions in circulating B cell subsets and immunoglobulin G levels with long-term belimumab treatment in patients with SLE.,"OBJECTIVE


To examine the long-term changes in circulating B cell subsets and IgG levels at 5+ years of continuous belimumab treatment and their correlations with efficacy and safety measures.
METHODS


This was a post hoc analysis of a continuation study (BEL112233; NCT00724867) of eligible US patients who completed the 76-week BLISS-76 Study (BEL110751; NCT00410384), with up to eight calendar-years of follow-up and median (IQR) belimumab exposure of 310 (209, 364) weeks. From week 76, patients initially randomised to intravenous belimumab 1 mg/kg or 10 mg/kg every 4 weeks in BLISS-76 continued to receive the same dose in the continuation study, while those initially randomised to placebo received belimumab 10 mg/kg intravenous every 4 weeks during continuation. All patients continued to receive standard SLE therapy. Biomarker data were collected, and the effects on baseline and early changes (weeks 0-24 after starting belimumab) from baseline in biomarkers on SLE Responder Index (SRI-4) and infection rate were evaluated.
RESULTS


Of the 819 patients from BLISS-76, 268 self-selecting patients entered BEL112233. Compared with baseline, B cell subset counts decreased by 40%-99% after 312 weeks (6 years), and serum IgG levels decreased by 28% after 284 weeks. Higher baseline naïve B cell counts were associated with greater SRI-4 response rates (p<0.05), whereas higher baseline SLE subset plasma and short-lived plasma B cell counts were associated with lower SRI-4 response rates (p<0.05). Elevated baseline IgG levels were associated with increased infection rates over the treatment period (p<0.05), and early greater decreases in IgG levels were associated with higher SRI-4 response rates (p<0.05).
CONCLUSIONS


Belimumab treatment up to 312 weeks (6 years) resulted in substantial decreases in several circulating B cell subsets and IgG levels. Higher baseline naïve B cell counts and IgG levels were associated with improved SRI-4 response and increased infection rates, respectively.",2022,"Higher baseline naïve B cell counts and IgG levels were associated with improved SRI-4 response and increased infection rates, respectively.","['eligible US patients who completed the 76-week BLISS-76 Study (BEL110751; NCT00410384), with up to eight calendar-years of follow-up and median (IQR) belimumab exposure of 310 (209, 364) weeks', '819 patients from BLISS-76', 'patients with SLE']","['standard SLE therapy', 'placebo received belimumab', 'intravenous belimumab']","['Higher baseline naïve B cell counts and IgG levels', 'efficacy and safety measures', 'IgG levels', 'infection rates', 'several circulating B cell subsets and IgG levels', 'Elevated baseline IgG levels', 'circulating B cell subsets and immunoglobulin G levels', 'circulating B cell subsets and IgG levels', 'SRI-4 response rates', 'SLE Responder Index (SRI-4) and infection rate', 'baseline SLE subset plasma and short-lived plasma B cell counts', 'B cell subset counts', 'SRI-4 response and increased infection rates', 'serum IgG levels']","[{'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0456586', 'cui_str': 'Calendar year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0079004', 'cui_str': 'B-Cell Subsets'}, {'cui': 'C0202087', 'cui_str': 'Immunoglobulin G measurement'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",819.0,0.15465,"Higher baseline naïve B cell counts and IgG levels were associated with improved SRI-4 response and increased infection rates, respectively.","[{'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Struemper', 'Affiliation': 'Clinical Pharmacology Modeling & Simulation, GlaxoSmithKline, Research Triangle Park, North Carolina, USA herbert.x.struemper@gsk.com.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Kurtinecz', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Collegeville, Pennsylvania, USA (At the time of the study).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Edwards', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Chapel Hill, North Carolina, USA (At the time of the study).'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Freimuth', 'Affiliation': 'Freimuth Biopharmaceutical Consulting, Gaithersburg, Maryland, USA (At the time of the study).'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Roth', 'Affiliation': 'Research & Development, GlaxoSmithKline, Collegeville, South Carolina, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Stohl', 'Affiliation': 'Division of Rheumatology, Department of Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, USA.'}]",Lupus science & medicine,['10.1136/lupus-2021-000499']
1971,35136382,"Serum Levels of VWF, t-PA, TNF- α , and ICAM-1 in Patients Receiving Hemocoagulase Combined with Platelet-Rich Plasma during Total Hip Replacement.","Objectives


This study aimed to investigate the effect of hemocoagulase combined with platelet-rich plasma (PRP) in total hip replacement (THR) on reducing bleeding and improving knee joint function in the patients with osteoarthritis.
Methods


From February 2018 to February 2020, 80 osteoarthritis patients undergoing THR were included in the study, of which 40 cases were treated with PRP and hemocoagulase (test group) in the joint capsule in THR and the other 40 cases received saline and thrombin in the joint capsule after THR (control group). Postoperative drainage and corresponding functional exercise were performed for the two groups 12 hours after operation. The outcome measures including operation time, soft-tissue release, blood routine, drainage volume, perioperative blood loss, postoperative incision inflammation, deep vein thrombosis (DVT), and range of motion (ROM) of the joint were recorded.
Results


The hemoglobin and hematocrit values of the test group on the second postoperative day were significantly higher than those of the control group ( P  < 0.05). The postoperative drainage volume and perioperative blood loss were significantly lower than those of the control group ( P  < 0.05). The test group was better than the control group in the ROM of the joint at 7 and 15 days after the operation ( P  < 0.05). A lower value of prothrombin time and activated partial thromboplastin time was revealed in the test group compared with the control group ( P  < 0.05). No significant difference in the operation time, intraoperative soft-tissue release, postoperative incision inflammation, incidence of DVT, incidence of deep infection, and ROM at day 90 after THR was found in the two groups ( P  > 0.05).
Conclusions


The application of hemocoagulase combined with PRP in THR can reduce perioperative blood loss, increase wound healing speed and quality, and improve coagulation and immune function. It is a safe and effective method for the patients with knee osteoarthritis who underwent THR.",2022,The test group was better than the control group in the ROM of the joint at 7 and 15 days after the operation ( P  < 0.05).,"['Total Hip Replacement', 'patients with osteoarthritis', 'Patients Receiving Hemocoagulase', 'Methods\n\n\nFrom February 2018 to February 2020, 80 osteoarthritis patients undergoing THR were included in the study, of which 40 cases were treated with', 'patients with knee osteoarthritis who underwent THR']","['saline and thrombin', 'Postoperative drainage and corresponding functional exercise', 'Platelet-Rich Plasma', 'PRP in THR', 'hemocoagulase combined with platelet-rich plasma (PRP', 'total hip replacement (THR', 'PRP and hemocoagulase (test group) in the joint capsule in THR']","['postoperative drainage volume and perioperative blood loss', 'perioperative blood loss, increase wound healing speed and quality, and improve coagulation and immune function', 'hemoglobin and hematocrit values', 'Serum Levels of VWF, t-PA, TNF- α , and ICAM-1', 'prothrombin time and activated partial thromboplastin time', 'operation time, soft-tissue release, blood routine, drainage volume, perioperative blood loss, postoperative incision inflammation, deep vein thrombosis (DVT), and range of motion (ROM) of the joint were recorded', 'knee joint function', 'operation time, intraoperative soft-tissue release, postoperative incision inflammation, incidence of DVT, incidence of deep infection, and ROM at day 90 after THR']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0917789', 'cui_str': 'Hemocoagulase'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0917789', 'cui_str': 'Hemocoagulase'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206207', 'cui_str': 'Structure of articular capsule'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2242518', 'cui_str': 'Soft tissue release'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]",40.0,0.0139453,The test group was better than the control group in the ROM of the joint at 7 and 15 days after the operation ( P  < 0.05).,"[{'ForeName': 'Yaobin', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Joint Orthopaedics, Yuebei People's Hospital, Shaoguan City, Guangdong Province 512025, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': ""Department of Joint Orthopaedics, Yuebei People's Hospital, Shaoguan City, Guangdong Province 512025, China.""}, {'ForeName': 'De', 'Initials': '', 'LastName': 'Zhang', 'Affiliation': ""Department of Joint Orthopaedics, Yuebei People's Hospital, Shaoguan City, Guangdong Province 512025, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Joint Orthopaedics, Yuebei People's Hospital, Shaoguan City, Guangdong Province 512025, China.""}]",Genetics research,['10.1155/2022/2766215']
1972,35137532,"A randomized, controlled, feasibility study of RD-X19 in subjects with mild-to-moderate COVID-19 in the outpatient setting.","The RD-X19 is an investigational, handheld medical device precisely engineered to emit blue light through the oral cavity to target the oropharynx and surrounding tissues. At doses shown to be noncytotoxic in an in vitro three-dimensional human epithelial tissue model, the monochromatic visible light delivered by RD-X19 results in light-initiated expression of immune stimulating cytokines IL-1α and IL-1β, with corresponding inhibition of severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) replication. A single exposure of 425 nm blue light at 60 J/cm 2  led to greater than 99% reductions against all SARS-CoV-2 strains tested in vitro, including the more transmissible (Alpha) and immune evasive (Beta) variants. These preclinical findings along with other studies led to a randomized, double-blind, sham-controlled early feasibility study using the investigational device as a treatment for outpatients with mild to moderate coronavirus disease 2019 (COVID-19). The study enrolled 31 subjects with a positive SARS-CoV-2 antigen test and at least two moderate COVID-19 signs and symptoms at baseline. Subjects were randomized 2:1 (RD-X19: sham) and treated twice daily for 4 days. Efficacy outcome measures included assessments of SARS-CoV-2 saliva viral load and clinical assessments of COVID-19. There were no local application site reactions and no device-related adverse events. At the end of the study (day 8), the mean change in log 10  viral load was -3.29 for RD-X19 and -1.81 for sham, demonstrating a treatment benefit of -1.48 logs (95% confidence internal, -2.88 to -0.071, nominal p = 0.040). Among the clinical outcome measures, differences between RD-X19 and sham were also observed, with a 57-h reduction of median time to sustained resolution of COVID-19 signs and symptoms (log rank test, nominal p = 0.044).",2022,There were no local application site reactions and no device-related adverse events.,"['31 subjects with a positive SARS-CoV-2 antigen test and at least two moderate COVID-19 signs and symptoms at baseline', 'subjects with mild-to-moderate COVID-19 in the outpatient setting', 'outpatients with mild to moderate COVID-19']",['RD-X19'],"['SARS-CoV-2 saliva viral load and clinical assessments of COVID-19', 'median time to sustained resolution of COVID-19 signs and symptoms', 'local application site reactions and no device-related adverse events', 'mean change in log 10  viral load']","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0729856', 'cui_str': 'Antigen test'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]",[],"[{'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0151505', 'cui_str': 'Application site reaction'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",31.0,0.30025,There were no local application site reactions and no device-related adverse events.,"[{'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Stasko', 'Affiliation': 'EmitBio Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Cockrell', 'Affiliation': 'EmitBio Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Jacob F', 'Initials': 'JF', 'LastName': 'Kocher', 'Affiliation': 'EmitBio Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Henson', 'Affiliation': 'EmitBio Inc, Durham, North Carolina, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Emerson', 'Affiliation': 'EmitBio Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Symbio, LLC, Port Jefferson, New York, USA.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Smith', 'Affiliation': 'Adaptive Plus, LLC, Durham, North Carolina, USA.'}, {'ForeName': 'Nathan H', 'Initials': 'NH', 'LastName': 'Henderson', 'Affiliation': 'MRIGlobal, Kansas City, Missouri, USA.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Wood', 'Affiliation': 'MRIGlobal, Kansas City, Missouri, USA.'}, {'ForeName': 'Shelton S', 'Initials': 'SS', 'LastName': 'Bradrick', 'Affiliation': 'MRIGlobal, Kansas City, Missouri, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Jones', 'Affiliation': 'J&S Studies, Inc, College Station, Texas, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Santander', 'Affiliation': 'APF Research International, LLC, Miami, Florida, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'McNeil', 'Affiliation': 'EmitBio Inc, Durham, North Carolina, USA.'}]",Clinical and translational science,['10.1111/cts.13249']
1973,35138715,[Home sweat hospital-at-home].,"This article discusses the outcomes of a randomized controlled trial by Shepperd et al in the UK on comprehensive geriatric assessment and hospital-at-home (HaH) for older adults, compared to hospitalization and the implications for the Dutch health care system. The authors found that older adults have comparable outcomes in terms of living at home and mortality at six months, but older adults were more satisfied with the HaH care, less often experienced a delirium and less older adults were admitted to the nursing home. The hospital-at-home model has some other advantages, as it minimizes transitions, older adults are more active in their own environment and experience more autonomy and self-management. To implement this model in the Netherlands it is important to sharply define the target group for HaH, to have a team with nurse practitioners and geriatrician who is able to provide the care 24/7 and to build an acute geriatric infrastructure in primary care, so the HaH is a serious alternative to hospital care.",2022,"The authors found that older adults have comparable outcomes in terms of living at home and mortality at six months, but older adults were more satisfied with the HaH care, less often experienced a delirium and less older adults were admitted to the nursing home.",['older adults'],[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],[],,0.0406065,"The authors found that older adults have comparable outcomes in terms of living at home and mortality at six months, but older adults were more satisfied with the HaH care, less often experienced a delirium and less older adults were admitted to the nursing home.","[{'ForeName': 'Bianca M', 'Initials': 'BM', 'LastName': 'Buurman', 'Affiliation': 'Amsterdam UMC, afd. Interne-Ouderengeneeskunde en afd. Ouderengeneeskunde, Amsterdam.'}]",Nederlands tijdschrift voor geneeskunde,[]
1974,35138714,[Psilocybin compared with escitalopram for depression].,"Carhart-Harris et al. performed a study in which they compared psilocybin in combination with psychotherapy to escitalopram in combination with psychotherapy for depression. In this commentary, the author first summarizes the study results: in this double blind randomized controlled trial, psilocybin yielded an antidepressant effect comparable to escitalopram. Then, the author reflects on both the implications this study might have for future clinical practice and on the still existing shortcomings pertaining to psychedelic research in psychiatry. Psychedelic treatments might become guideline-based treatment after phase III trials have been performed. However, to date, only phase II trials have been performed and little is known about psilocybin's ability to maintain its antidepressant effect. In addition, blinding issues with psychedelic treatments remain, and media might have presented a premature and overly positive image of psychedelics as a possible treatment for psychiatric illness.",2022,"However, to date, only phase II trials have been performed and little is known about psilocybin's ability to maintain its antidepressant effect.",[],"['Psilocybin', 'psilocybin']",[],[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}]",[],,0.162776,"However, to date, only phase II trials have been performed and little is known about psilocybin's ability to maintain its antidepressant effect.","[{'ForeName': 'Jurriaan F M', 'Initials': 'JFM', 'LastName': 'Strous', 'Affiliation': 'Universitair Medisch Centrum Groningen, afd. Psychiatrie, Groningen.'}]",Nederlands tijdschrift voor geneeskunde,[]
1975,35139271,Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S.,"BACKGROUND


The Ad26.COV2.S vaccine was highly effective against severe-critical coronavirus disease 2019 (Covid-19), hospitalization, and death in the primary phase 3 efficacy analysis.
METHODS


We conducted the final analysis in the double-blind phase of our multinational, randomized, placebo-controlled trial, in which adults were assigned in a 1:1 ratio to receive single-dose Ad26.COV2.S (5×10 10  viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe-critical Covid-19 with onset at least 14 days after administration and at least 28 days after administration in the per-protocol population. Safety and key secondary and exploratory end points were also assessed.
RESULTS


Median follow-up in this analysis was 4 months; 8940 participants had at least 6 months of follow-up. In the per-protocol population (39,185 participants), vaccine efficacy against moderate to severe-critical Covid-19 at least 14 days after administration was 56.3% (95% confidence interval [CI], 51.3 to 60.8; 484 cases in the vaccine group vs. 1067 in the placebo group); at least 28 days after administration, vaccine efficacy was 52.9% (95% CI, 47.1 to 58.1; 433 cases in the vaccine group vs. 883 in the placebo group). Efficacy in the United States, primarily against the reference strain (B.1.D614G) and the B.1.1.7 (alpha) variant, was 69.7% (95% CI, 60.7 to 76.9); efficacy was reduced elsewhere against the P.1 (gamma), C.37 (lambda), and B.1.621 (mu) variants. Efficacy was 74.6% (95% CI, 64.7 to 82.1) against severe-critical Covid-19 (with only 4 severe-critical cases caused by the B.1.617.2 [delta] variant), 75.6% (95% CI, 54.3 to 88.0) against Covid-19 leading to medical intervention (including hospitalization), and 82.8% (95% CI, 40.5 to 96.8) against Covid-19-related death, with protection lasting 6 months or longer. Efficacy against any severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was 41.7% (95% CI, 36.3 to 46.7). Ad26.COV2.S was associated with mainly mild-to-moderate adverse events, and no new safety concerns were identified.
CONCLUSIONS


A single dose of Ad26.COV2.S provided 52.9% protection against moderate to severe-critical Covid-19. Protection varied according to variant; higher protection was observed against severe Covid-19, medical intervention, and death than against other end points and lasted for 6 months or longer. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722.).",2022,"Efficacy was 74.6% (95% CI, 64.7 to 82.1) against severe-critical Covid-19 (with only 4 severe-critical cases caused by the B.1.617.2 [delta] variant), 75.6% (95% CI, 54.3 to 88.0) against Covid-19 leading to medical intervention (including hospitalization), and 82.8% (95% CI, 40.5 to 96.8) against Covid-19-related death, with protection lasting 6 months or longer.",['severe acute respiratory syndrome coronavirus 2'],"['placebo', 'Single-Dose']","['vaccine efficacy against moderate to severe-critical Covid-19', 'Efficacy', 'vaccine efficacy', 'vaccine efficacy against moderate to severe-critical Covid-19 with onset', 'severe-critical Covid-19', 'Covid-19-related death']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",39185.0,0.760542,"Efficacy was 74.6% (95% CI, 64.7 to 82.1) against severe-critical Covid-19 (with only 4 severe-critical cases caused by the B.1.617.2 [delta] variant), 75.6% (95% CI, 54.3 to 88.0) against Covid-19 leading to medical intervention (including hospitalization), and 82.8% (95% CI, 40.5 to 96.8) against Covid-19-related death, with protection lasting 6 months or longer.","[{'ForeName': 'Jerald', 'Initials': 'J', 'LastName': 'Sadoff', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Gray', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Vandebosch', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Cárdenas', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Georgi', 'Initials': 'G', 'LastName': 'Shukarev', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Goepfert', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Truyers', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Van Dromme', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Spiessens', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vingerhoets', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Custers', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Scheper', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Treanor', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Ryser', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Swann', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Marovich', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Stoddard', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hardt', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ruiz-Guiñazú', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Le Gars', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Van Hoof', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Struyf', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': 'Macaya', 'Initials': 'M', 'LastName': 'Douoguih', 'Affiliation': 'From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., K.H., J.R.-G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2117608']
1976,35143603,Effect of Intra-arterial Alteplase vs Placebo Following Successful Thrombectomy on Functional Outcomes in Patients With Large Vessel Occlusion Acute Ischemic Stroke: The CHOICE Randomized Clinical Trial.,"Importance


It is estimated that only 27% of patients with acute ischemic stroke and large vessel occlusion who undergo successful reperfusion after mechanical thrombectomy are disability free at 90 days. An incomplete microcirculatory reperfusion might contribute to these suboptimal clinical benefits.
Objective


To investigate whether treatment with adjunct intra-arterial alteplase after thrombectomy improves outcomes following reperfusion.
Design, Setting, and Participants


Phase 2b randomized, double-blind, placebo-controlled trial performed from December 2018 through May 2021 in 7 stroke centers in Catalonia, Spain. The study included 121 patients with large vessel occlusion acute ischemic stroke treated with thrombectomy within 24 hours after stroke onset and with an expanded Treatment in Cerebral Ischemia angiographic score of 2b50 to 3.
Interventions


Participants were randomized to receive intra-arterial alteplase (0.225 mg/kg; maximum dose, 22.5 mg) infused over 15 to 30 minutes (n = 61) or placebo (n = 52).
Main Outcomes and Measures


The primary outcome was the difference in proportion of patients achieving a score of 0 or 1 on the 90-day modified Rankin Scale (range, 0 [no symptoms] to 6 [death]) in all patients treated as randomized. Safety outcomes included rate of symptomatic intracranial hemorrhage and death.
Results


The study was terminated early for inability to maintain placebo availability and enrollment rate because of the COVID-19 pandemic. Of 1825 patients with acute ischemic stroke treated with thrombectomy at the 7 study sites, 748 (41%) patients fulfilled the angiographic criteria, 121 (7%) patients were randomized (mean age, 70.6 [SD, 13.7] years; 57 women [47%]), and 113 (6%) were treated as randomized. The proportion of participants with a modified Rankin Scale score of 0 or 1 at 90 days was 59.0% (36/61) with alteplase and 40.4% (21/52) with placebo (adjusted risk difference, 18.4%; 95% CI, 0.3%-36.4%; P = .047). The proportion of patients with symptomatic intracranial hemorrhage within 24 hours was 0% with alteplase and 3.8% with placebo (risk difference, -3.8%; 95% CI, -13.2% to 2.5%). Ninety-day mortality was 8% with alteplase and 15% with placebo (risk difference, -7.2%; 95% CI, -19.2% to 4.8%).
Conclusions and Relevance


Among patients with large vessel occlusion acute ischemic stroke and successful reperfusion following thrombectomy, the use of adjunct intra-arterial alteplase compared with placebo resulted in a greater likelihood of excellent neurological outcome at 90 days. However, because of study limitations, these findings should be interpreted as preliminary and require replication.
Trial Registration


ClinicalTrials.gov Identifier: NCT03876119; EudraCT Number: 2018-002195-40.",2022,"Ninety-day mortality was 8% with alteplase and 15% with placebo (risk difference, -7.2%; 95% CI, -19.2% to 4.8%).
","['patients with large vessel occlusion acute ischemic stroke', 'Patients', '121 patients with large vessel occlusion acute ischemic stroke treated with thrombectomy within 24 hours after stroke onset and with an expanded Treatment in Cerebral Ischemia angiographic score of 2b50 to 3', 'With Large Vessel Occlusion Acute Ischemic Stroke', '1825 patients with acute ischemic stroke treated with thrombectomy at the 7 study sites, 748 (41%) patients fulfilled the angiographic criteria, 121 (7%) patients were randomized (mean age, 70.6 [SD, 13.7] years; 57 women [47%]), and 113 (6', 'controlled trial performed from December 2018 through May 2021 in 7 stroke centers in Catalonia, Spain']","['placebo', 'Intra-arterial Alteplase vs Placebo', 'intra-arterial alteplase']","['proportion of patients achieving a score of 0 or 1 on the 90-day modified Rankin Scale (range, 0', 'Ninety-day mortality', 'Functional Outcomes', 'rate of symptomatic intracranial hemorrhage and death', 'modified Rankin Scale score', 'symptomatic intracranial hemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0694634', 'cui_str': 'Intra-arterial'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",121.0,0.535556,"Ninety-day mortality was 8% with alteplase and 15% with placebo (risk difference, -7.2%; 95% CI, -19.2% to 4.8%).
","[{'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Renú', 'Affiliation': 'Department of Neuroscience, Comprehensive Stroke Center, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Millán', 'Affiliation': 'Stroke Unit, Department of Neuroscience, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'San Román', 'Affiliation': 'Neuroradiology Service, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Blasco', 'Affiliation': 'Neuroradiology Service, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Martí-Fàbregas', 'Affiliation': 'Department of Neurology, Stroke Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Terceño', 'Affiliation': 'Neuroradiology Service, Hospital Universitari de Girona Doctor Josep Trueta, Girona, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Amaro', 'Affiliation': 'Department of Neuroscience, Comprehensive Stroke Center, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Serena', 'Affiliation': ""Neurology Service, Stroke Unit, Institut d'Investigació Biomèdica de Girona (IDIBGI), Hospital Universitari de Girona Doctor Josep Trueta, Girona, Spain.""}, {'ForeName': 'Xabier', 'Initials': 'X', 'LastName': 'Urra', 'Affiliation': 'Department of Neuroscience, Comprehensive Stroke Center, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Laredo', 'Affiliation': 'Department of Neuroscience, Comprehensive Stroke Center, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Barranco', 'Affiliation': 'Department of Interventional Neuroradiology, Bellvitge University Hospital, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Pol', 'Initials': 'P', 'LastName': 'Camps-Renom', 'Affiliation': 'Department of Neurology, Stroke Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Zarco', 'Affiliation': 'Neuroradiology Service, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Oleaga', 'Affiliation': 'Neuroradiology Service, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Cardona', 'Affiliation': 'Department of Neurology, Bellvitge University Hospital, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Castaño', 'Affiliation': 'Interventional Neuroradiology Unit, Department of Neuroscience, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Macho', 'Affiliation': 'Neuroradiology Service, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Cuadrado-Godía', 'Affiliation': ""Department of Neurology, Institut Hospital del Mar d'Investigacions Mèdiques, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Vivas', 'Affiliation': 'Department of Neuroradiology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'López-Rueda', 'Affiliation': 'Neuroradiology Service, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Guimaraens', 'Affiliation': 'Department of Neuroradiology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ramos-Pachón', 'Affiliation': 'Stroke Unit, Department of Neuroscience, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Roquer', 'Affiliation': ""Department of Neurology, Institut Hospital del Mar d'Investigacions Mèdiques, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Muchada', 'Affiliation': ""Stroke Unit, Department of Neurology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Tomasello', 'Affiliation': ""Department of Neuroradiology, Hospital Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dávalos', 'Affiliation': 'Stroke Unit, Department of Neuroscience, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': 'Medical Statistics Core Facility, Clinical Pharmacology Service, IDIBAPS, Hospital Clínic Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Chamorro', 'Affiliation': 'Department of Neuroscience, Comprehensive Stroke Center, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2022.1645']
1977,35143552,Understanding how individualised physiotherapy or advice altered different elements of disability for people with low back pain using network analysis.,"PURPOSE


The Oswestry Disability Index (ODI) is a common aggregate measure of disability for people with Low Back Pain (LBP). Scores on individual items and the relationship between items of the ODI may help understand the complexity of low back disorders and their response to treatment. In this study, we present a network analysis to explore how individualised physiotherapy or advice might influence individual items of the ODI, and the relationship between those items, at different time points for people with LBP.
METHODS


Data from a randomised controlled trial (n = 300) comparing individualised physiotherapy versus advice for low back pain were used. A network analysis was performed at baseline, 5, 10, 26 and 52 weeks, with the 10 items of the Oswestry Disability Index modelled as continuous variables and treatment group (Individualised Physiotherapy or Advice) modelled as a dichotomous variable. A Mixed Graphical Model was used to estimate associations between variables in the network, while centrality indices (Strength, Closeness and Betweenness) were calculated to determine the importance of each variable.
RESULTS


Individualised Physiotherapy was directly related to lower Sleep and Pain scores at all follow-up time points relative to advice, as well as a lower Standing score at 10-weeks, and higher Lifting and Travelling scores at 5-weeks. The strongest associations in the network were between Sitting and Travelling at weeks 5 and 26, between Walking and Standing at week 10, and between Sitting and Standing scores at week 52. ODI items with the highest centrality measures were consistently found to be Pain, Work and Social Life.
CONCLUSION


This study represents the first to understand how individualised physiotherapy or advice differentially altered disability in people with LBP. Individualised Physiotherapy directly reduced Pain and Sleep more effectively than advice, which in turn may have facilitated improvements in other disability items. Through their high centrality measures, Pain may be considered as a candidate therapeutic target for optimising LBP management, while Work and Socialising may need to be addressed via intermediary improvements in lifting, standing, walking, travelling or sleep. Slower (5-week follow-up) improvements in Lifting and Travelling as an intended element of the Individualised Physiotherapy approach did not negatively impact any longer-term outcomes.
TRIALS REGISTRATION


ACTRN12609000834257.",2022,"Individualised Physiotherapy was directly related to lower Sleep and Pain scores at all follow-up time points relative to advice, as well as a lower Standing score at 10-weeks, and higher Lifting and Travelling scores at 5-weeks.","['people with LBP', 'people with Low Back Pain (LBP']",['individualised physiotherapy'],"['Pain, Work and Social Life', 'Oswestry Disability Index (ODI', 'Pain and Sleep', 'lower Sleep and Pain scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",300.0,0.050314,"Individualised Physiotherapy was directly related to lower Sleep and Pain scores at all follow-up time points relative to advice, as well as a lower Standing score at 10-weeks, and higher Lifting and Travelling scores at 5-weeks.","[{'ForeName': 'Bernard X W', 'Initials': 'BXW', 'LastName': 'Liew', 'Affiliation': 'School of Sport, Rehabilitation and Exercise Sciences, University of Essex, Colchester, Essex, United Kingdom.'}, {'ForeName': 'Jon J', 'Initials': 'JJ', 'LastName': 'Ford', 'Affiliation': 'Discipline of Physiotherapy, School of Allied Health, Human Services & Sport, La Trobe University, Melbourne Australia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Briganti', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, Massachusetts United States of America.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Hahne', 'Affiliation': 'Discipline of Physiotherapy, School of Allied Health, Human Services & Sport, La Trobe University, Melbourne Australia.'}]",PloS one,['10.1371/journal.pone.0263574']
1978,35158205,"Adjuvant durvalumab for esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy: a placebo-controlled, randomized, double-blind, phase II study.","BACKGROUND


We evaluated the efficacy of adjuvant durvalumab after neoadjuvant concurrent chemoradiotherapy (CCRT) in patients with esophageal squamous cell carcinoma (ESCC).
PATIENTS AND METHODS


This randomized, double-blind, phase II study included patients with ESCC who underwent curative surgery after neoadjuvant CCRT. Patients were randomized to receive either durvalumab (20 mg/kg/i.v. every 4 weeks for 12 months) or placebo in a 1:1 ratio and were stratified by age and pathologic tumor stage. The primary endpoint was disease-free survival (DFS).
RESULTS


Between March 2016 and June 2018, 86 patients were randomized to the durvalumab (n = 45) or placebo (n = 41) arm. The median follow-up duration was 38.7 months. There was no difference in DFS [hazard ratio (HR) 1.18, 95% confidence interval (CI) 0.62-2.27, P = 0.61] or overall survival (HR 1.08, 95% CI 0.52-2.24, P = 0.85) between the two arms. Subgroup analysis was performed for patients for whom the post-CCRT programmed death-ligand 1 (PD-L1) expression profile could be assessed (n = 54). In the PD-L1-positive group, based on tumor proportion score ≥1%, durvalumab was associated with longer overall survival compared with the placebo (36-month survival rate: 94% versus 64%; HR 0.42, 95% CI 0.10-1.76), while in the PD-L1-negative group, it was associated with shorter overall survival (42% versus 55%; HR 1.53, 95% CI 0.48-4.83), showing the tendency of interaction between post-CCRT PD-L1 status and adjuvant durvalumab therapy for overall survival (interaction P = 0.18).
CONCLUSIONS


We failed to demonstrate that adjuvant durvalumab improved survival after neoadjuvant CCRT in patients with ESCC. However, post-CCRT PD-L1 expression could predict the survival of patients who receive adjuvant durvalumab after neoadjuvant CCRT, which needs to be validated.",2022,There was no difference in DFS [hazard ratio (HR),"['patients with ESCC', '86 patients', 'Between March 2016 and June 2018', 'esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy', 'patients with ESCC who underwent curative surgery after neoadjuvant CCRT', 'patients with esophageal squamous cell carcinoma (ESCC']","['placebo', 'adjuvant durvalumab after neoadjuvant concurrent chemoradiotherapy (CCRT', 'Adjuvant durvalumab', 'durvalumab']","['DFS [hazard ratio (HR', 'survival', 'overall survival', 'disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",86.0,0.729139,There was no difference in DFS [hazard ratio (HR),"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Sun', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: jongmu.sun@skku.edu.'}, {'ForeName': 'Y-L', 'Initials': 'YL', 'LastName': 'Choi', 'Affiliation': 'Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Oh', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Chi', 'Affiliation': 'Department of Health Sciences and Technology, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, Republic of Korea.'}, {'ForeName': 'S-H', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'S-H', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, USA.'}, {'ForeName': 'M-J', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Ahn', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Shim', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",ESMO open,['10.1016/j.esmoop.2022.100385']
1979,35158135,"The effect of neonatal resuscitation training based on a serious game simulation method on nursing students' knowledge, skills, satisfaction and self-confidence levels: A randomized controlled trial.","BACKGROUND


Although students are well prepared theoretically, they lack real-life practical skills because they have not faced an adequate number of emergencies such as neonatal resuscitation.
OBJECTIVES


This study was conducted with the objective of determining the impact of integrating serious game simulation (SGS) into neonatal resuscitation training on the neonatal resuscitation related knowledge, skills, satisfaction with training, and self confidence in learning of nursing students.
DESIGN


The study is a randomized controlled, pre-test post-test design and single-blind study.
SETTINGS AND PARTICIPANTS


This study was conducted on 90 undergraduate nursing students (SGS based training group = 45, control group = 45) enrolled in the fifth semester at the Faculty of Nursing.
METHODS


The students were allocated with simple randomization method to intervention and control groups. The training program prepared on the basis of neonatal resuscitation algorithm used a neonatal resuscitation serious game simulation method. At the same time, the serious game simulation method was used as a pre-test and post-test skill assessment tool. Support was obtained from a statistician in evaluation of the data and the data were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 25.0 program.
RESULTS


Post-test measurements indicated a statistically significant positive difference in the ventilation and chest compression performing skills of the intervention group compared to the control group (p = .011, p = .020, respectively). A considerable increase was found in the knowledge and skills level of both groups, after the neonatal resuscitation training (p < .05). The score averages of the Student Satisfaction and Self-Confidence in Learning Scale and its sub-dimensions were high for both groups.
CONCLUSIONS


It was concluded that the serious game simulation application used in neonatal resuscitation training was effective in raising the students' ventilation and compression performing skills.",2022,"RESULTS


Post-test measurements indicated a statistically significant positive difference in the ventilation and chest compression performing skills of the intervention group compared to the control group (p = .011, p = .020, respectively).","['nursing students', '90 undergraduate nursing students (SGS based training group\xa0=\xa045, control group\xa0=\xa045) enrolled in the fifth semester at the Faculty of Nursing']","['neonatal resuscitation training', 'integrating serious game simulation (SGS) into neonatal resuscitation training']","['knowledge and skills level', 'score averages of the Student Satisfaction and Self-Confidence in Learning Scale and its sub-dimensions', 'neonatal resuscitation related knowledge, skills, satisfaction with training, and self confidence', 'ventilation and chest compression performing skills', 'knowledge, skills, satisfaction and self-confidence levels']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0204928', 'cui_str': 'CPR education'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]",90.0,0.00412685,"RESULTS


Post-test measurements indicated a statistically significant positive difference in the ventilation and chest compression performing skills of the intervention group compared to the control group (p = .011, p = .020, respectively).","[{'ForeName': 'Süreyya', 'Initials': 'S', 'LastName': 'Sarvan', 'Affiliation': 'Akdeniz University, Faculty of Nursing, Dumlupinar Boulevard, Campus, 07058 Konyaaltı, Antalya, Turkey. Electronic address: ssarvan@akdeniz.edu.tr.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Efe', 'Affiliation': 'Akdeniz University, Faculty of Nursing, Dumlupinar Boulevard, Campus, 07058 Konyaaltı, Antalya, Turkey. Electronic address: eefe@akdeniz.edu.tr.'}]",Nurse education today,['10.1016/j.nedt.2022.105298']
1980,35158086,Effect of the New Nordic Diet compared with usual care on glucose control in gestational diabetes mellitus: Study protocol for the randomized controlled trial intervention with new Nordic DIet in women with GestatiOnal diabetes mellitus (iNDIGO).,"BACKGROUND


Gestational diabetes mellitus (GDM) is a pregnancy complication associated with short- and long-term health consequences for mother and child. First line treatment is diet and exercise but there is a recognized knowledge gap as to what diet treatment is optimal. A healthy Nordic diet has been associated with improved health but no studies in women with GDM exist. The New Nordic Diet (NND) is an initiative with the purpose to develop a healthy Nordic diet including foods with the potential to grow in Nordic countries; including fruit, berries, vegetables, whole-grain cereal products, nuts, fish, and rapeseed oil. The purpose of the intervention with new Nordic DIet in women with GestatiOnal diabetes mellitus (iNDIGO) is to test if the NND compared with usual care improves glucose control in women with GDM.
METHODS


The iNDIGO study is a randomized parallel controlled trial where 50 women with GDM will be randomized to either an NND or usual care for 14 days (30-32 weeks of gestation). Participants in the NND group will receive menus and food bags containing foods to be consumed. Primary outcome is glycemic control (time in target) measured using continuous glucose monitoring. Compliance to the dietary intervention will be tested using dietary biomarkers and adherence questionnaires.
CONCLUSION


Diet treatment represents first line treatment in GDM but it remains unclear what type of diets are effective. iNDIGO is an efficacy study and will provide evidence as to whether a healthy Nordic diet can improve glucose control in women with GDM.
TRIAL REGISTRATION


ClinicalTrials.gov registration Number: NCT04169243. Registered 19 November 2019, https://clinicaltrials.gov/ct2/show/NCT04169243.",2022,The iNDIGO study is a randomized parallel controlled trial where 50 women with GDM will be randomized to either an NND or usual care for 14 days (30-32 weeks of gestation).,"['50 women with GDM', 'women with GestatiOnal diabetes mellitus (iNDIGO', 'women with GDM exist', 'women with GDM', 'Gestational diabetes mellitus (GDM', 'gestational diabetes mellitus']","['new Nordic DIet', 'New Nordic Diet', 'NND or usual care', 'usual care', 'New Nordic Diet (NND', 'diet and exercise']",['glycemic control (time in target) measured using continuous glucose monitoring'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0021218', 'cui_str': 'Indigo'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",50.0,0.0359637,The iNDIGO study is a randomized parallel controlled trial where 50 women with GDM will be randomized to either an NND or usual care for 14 days (30-32 weeks of gestation).,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Karlsson', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of medicine, Sahlgrenska Academy, University of Gothenburg, S-40530 Gothenburg, Sweden; Department of Biology and Biological Engineering, Division of Food and Nutrition Science, Chalmers University of Technology, S-41296 Gothenburg, Sweden. Electronic address: therese.karlsson@gu.se.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Augustin', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of medicine, Sahlgrenska Academy, University of Gothenburg, S-40530 Gothenburg, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lindqvist', 'Affiliation': 'Department of Nursing, Umeå University, S-90187 Umeå, Sweden; Department of Clinical Sciences, Obstetrics and Gynecology, Umeå University, S-90185 Umeå, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Otten', 'Affiliation': 'Department of Public Health and Clinical Medicine, Medicine, Umeå University, S-90185 Umeå, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Petersson', 'Affiliation': 'Department of Clinical Sciences, Obstetrics and Gynecology, Umeå University, S-90185 Umeå, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Storck-Lindholm', 'Affiliation': 'Department of Obstetrics and Gynecology, Södersjukhuset, S-11221 Stockholm, Sweden.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Mogren', 'Affiliation': 'Department of Clinical Sciences, Obstetrics and Gynecology, Umeå University, S-90185 Umeå, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Winkvist', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Institute of medicine, Sahlgrenska Academy, University of Gothenburg, S-40530 Gothenburg, Sweden; Department of Public Health and Clinical Medicine, Sustainable Health, Umeå University, S-90185 Umeå, Sweden.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106706']
1981,35158081,"A Commentary on ""Preoperative carbohydrate loading with individualized supplemental insulin in diabetic patients undergoing gastrointestinal surgery: A randomized trial"" (Int. J. Surg. 2022;98:106215).",,2022,,['diabetic patients undergoing gastrointestinal surgery'],[],[],"[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}]",[],[],,0.115514,,"[{'ForeName': 'Yahao', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: laiyahao2021@163.com.'}, {'ForeName': 'Mingcheng', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: ymc19950616@163.com.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: xuhongvip@yeah.net.'}, {'ForeName': 'Zongke', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: zhouzongke@scu.edu.cn.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2022.106251']
1982,35162053,Effects of Direction-Specific Training Interventions on Physical Performance and Inter-Limb Asymmetries.,"This study analyzed the effects of two different training programs on functional performance and inter-limb asymmetries in basketball players. Twenty-four elite youth basketball players were randomly assigned to a training program including variable unilateral horizontal movements (VUH, n = 12) or unilateral lateral movements (VUL, n = 12). Eccentric-overload training (EOT) was performed twice a week for a six-week period. Functional performance assessment included a countermovement jump test, unilateral multidirectional jumping tests (i.e., lateral, horizontal, and vertical), a rebound jump test, a limb symmetry index, a 25 m linear sprint test, and several change of direction (COD) tests. Within-group analysis showed substantial improvements in almost all functional tests in both groups (ES = 0.35-0.89). Furthermore, almost all jumping asymmetries were improved in both groups (ES = 0.38-0.69) except for vertical jumping asymmetry in VUL (ES = -0.04). Between-group analyses showed a substantial and possibly better performance in vertical jumping asymmetry and 5 m in VUH compared to that of VUL, respectively. In contrast, lateral jumping with left (ES = 1.22) and right leg (ES = 0.49) were substantially greater in VUL than in VUH. Specific force-vector training programs induced substantial improvements in both functional performance tests and inter-limb asymmetries, although greater improvements of lateral and horizontal variables may depend on the specific force vector targeted.",2022,"Furthermore, almost all jumping asymmetries were improved in both groups (ES = 0.38-0.69) except for vertical jumping asymmetry in VUL (ES = -0.04).","['basketball players', 'Twenty-four elite youth basketball players']","['Specific force-vector training programs', 'Direction-Specific Training Interventions', 'training program including variable unilateral horizontal movements (VUH, n = 12) or unilateral lateral movements (VUL', 'Eccentric-overload training (EOT']","['countermovement jump test, unilateral multidirectional jumping tests (i.e., lateral, horizontal, and vertical), a rebound jump test, a limb symmetry index, a 25 m linear sprint test, and several change of direction (COD) tests', 'right leg', 'functional performance and inter-limb asymmetries', 'Physical Performance and Inter-Limb Asymmetries']","[{'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0230415', 'cui_str': 'Structure of right lower limb'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C2938981', 'cui_str': 'Limb asymmetry'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.00802135,"Furthermore, almost all jumping asymmetries were improved in both groups (ES = 0.38-0.69) except for vertical jumping asymmetry in VUL (ES = -0.04).","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gonzalo-Skok', 'Affiliation': 'Department of Return to Play, Sevilla FC, 41005 Seville, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sánchez-Sabaté', 'Affiliation': 'Faculty of Health Sciences, Universidad San Jorge, Campus Universitario, Autov A23 km 299, 50830 Villanueva de Gállego, Zaragoza, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Tous-Fajardo', 'Affiliation': 'INEFC Barcelona, SportsLab Performance, 08038 Barcelona, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Mendez-Villanueva', 'Affiliation': 'ASPIRE Academy for Sports Excellence, Doha 22287, Qatar.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bishop', 'Affiliation': 'London Sport Institute, School of Science and Technology, Middlesex University, Greenlands Lane, Allianz Park, London NW4 1RL, UK.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Piedrafita', 'Affiliation': 'Faculty of Health Sciences, Universidad San Jorge, Campus Universitario, Autov A23 km 299, 50830 Villanueva de Gállego, Zaragoza, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph19031029']
1983,35162296,Everyone Can Implement Eduball in Physical Education to Develop Cognitive and Motor Skills in Primary School Students.,"Studies suggest that incorporating core academic subjects into physical education (PE) stimulates the development of both motor and cognitive skills in primary school students. For example, several experiments show that children's participation in Eduball, i.e., a method that uses educational balls with printed letters, numbers, and other signs, improves their physical fitness while simultaneously developing their mathematical and language skills. However, the question of who should conduct such classes to make them most effective (regular classroom teachers, physical education teachers, or maybe both in cooperation?) remains unanswered. Here, we replicated a previous Eduball experiment, but now, instead of one experimental group, there were three. In the first, Eduball-classes were conducted by the classroom teacher, in the second, by the physical education teacher, and in the third, collaboratively. After one year intervention, all experimental groups significantly improved both their cognitive (mathematical, reading, and writing) and gross motor (locomotor and object control) skills, and these effects were larger than in the control group participating in traditional PE. Importantly, there were no differences in progression between the Eduball-groups. Thus, our study demonstrates that methods linking PE with cognitive tasks can be effectively used by both PE specialists and general classroom teachers.",2022,"After one year intervention, all experimental groups significantly improved both their cognitive (mathematical, reading, and writing) and gross motor (locomotor and object control) skills, and these effects were larger than in the control group participating in traditional PE.","['Primary School Students', 'primary school students']",[],"['cognitive (mathematical, reading, and writing) and gross motor (locomotor and object control) skills']","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0356722,"After one year intervention, all experimental groups significantly improved both their cognitive (mathematical, reading, and writing) and gross motor (locomotor and object control) skills, and these effects were larger than in the control group participating in traditional PE.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wawrzyniak', 'Affiliation': 'Department of Team Sports Games, Wroclaw University of Health and Sport Sciences, Mickiewicza 58, 51-684 Wroclaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Korbecki', 'Affiliation': 'Department of Team Sports Games, Wroclaw University of Health and Sport Sciences, Mickiewicza 58, 51-684 Wroclaw, Poland.'}, {'ForeName': 'Ireneusz', 'Initials': 'I', 'LastName': 'Cichy', 'Affiliation': 'Department of Team Sports Games, Wroclaw University of Health and Sport Sciences, Mickiewicza 58, 51-684 Wroclaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Kruszwicka', 'Affiliation': 'Learning Laboratory, Faculty of Educational Studies, Adam Mickiewicz University, Szamarzewskiego 89, 60-568 Poznan, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Przybyla', 'Affiliation': 'Learning Laboratory, Faculty of Educational Studies, Adam Mickiewicz University, Szamarzewskiego 89, 60-568 Poznan, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Klichowski', 'Affiliation': 'Learning Laboratory, Faculty of Educational Studies, Adam Mickiewicz University, Szamarzewskiego 89, 60-568 Poznan, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Rokita', 'Affiliation': 'Department of Team Sports Games, Wroclaw University of Health and Sport Sciences, Mickiewicza 58, 51-684 Wroclaw, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph19031275']
1984,35162126,An Experimental Study Evaluating the Influence of Front-of-Package Warning Labels on Adolescent's Purchase Intention of Processed Food Products.,"Front-of-package warning labels (WLs) are among the public health policies adopted by some countries, mainly in Latin-America, to tackle childhood obesity; however, their impact is still under review. The aim of this study was to assess, using an experimental design, whether WLs influence purchase intention of processed foods and identification of the healthiest products among adolescents in Peru, in May 2019, just before WLs mandatory implementation. Four hundred forty-nine adolescents from two public schools were randomly assigned to an experimental group (received three different processed products with either zero, one or two WLs, informing if they were high in sugar, sodium and/or saturated fats) or a control group (received the same products but unlabeled). Participants chose which product they would buy, and which they considered to be the healthiest. No differences between groups were found neither in purchase intention ( p  = 0.386) nor in the identification of the healthiest product ( p  = 0.322). In both groups, the most-selected product was always the healthiest of the triad (>40% in purchase intention and >80% in identification of the healthiest). Front-of-package WLs did not influence purchase intention, or identification of healthier products among adolescents from public schools in Peru. Mass media and educational campaigns should accompany the WLs implementation to help achieve the policy objective.",2022,"Front-of-package WLs did not influence purchase intention, or identification of healthier products among adolescents from public schools in Peru.","['Four hundred forty-nine adolescents from two public schools', 'adolescents from public schools in Peru']","['high in sugar, sodium and/or saturated fats) or a control group (received the same products but unlabeled', 'Front-of-Package Warning Labels']",['purchase intention'],"[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0805649,"Front-of-package WLs did not influence purchase intention, or identification of healthier products among adolescents from public schools in Peru.","[{'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Saavedra-Garcia', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Av. Armendariz 445, Miraflores, Lima 15074, Peru.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Moscoso-Porras', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Av. Armendariz 445, Miraflores, Lima 15074, Peru.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Diez-Canseco', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Av. Armendariz 445, Miraflores, Lima 15074, Peru.'}]",International journal of environmental research and public health,['10.3390/ijerph19031094']
1985,35162556,Effects of Periodontal Treatment in Patients with Periodontitis and Kidney Failure: A Pilot Study.,"Periodontitis and chronic kidney disease are both chronic inflammatory diseases and share some common risk factors. This 3-month pilot study aimed to clarify whether non-surgical periodontal therapy is beneficial in clinical, biochemical, and microbiological conditions in patients with periodontitis and kidney failure. Kidney failure patients with moderate to severe periodontitis were recruited from two hospitals. Treatment group received non-surgical periodontal therapy, and control group received oral hygiene instruction only. Outcome assessments were conducted 1 and 3 months after treatment. Non-parametric tests were used to analyze the patient-level data. Periodontal site-level assessments were analyzed by Student  t -test and paired  t -test. Statistical significance was set at  p -value < 0.05. A total of 11 subjects completed the study. There was no significant difference between groups in all-cause mortality, cardiovascular events, infection events, systemic parameters, and serum biomarkers. Comparing to control group, clinical periodontal parameters, gingival crevicular fluid interleukin-1β (IL-1β) level and periodontal pathogens showed significant improvement in the treatment group. Non-surgical periodontal treatment did not change systemic outcomes in kidney failure patients, but changed the local micro-environment.",2022,"Comparing to control group, clinical periodontal parameters, gingival crevicular fluid interleukin-1β (IL-1β) level and periodontal pathogens showed significant improvement in the treatment group.","['Kidney failure patients with moderate to severe periodontitis', 'A total of 11 subjects completed the study', 'kidney failure patients', 'Patients with Periodontitis and Kidney Failure', 'patients with periodontitis and kidney failure']","['non-surgical periodontal therapy, and control group received oral hygiene instruction only', 'Periodontal Treatment']","['clinical periodontal parameters, gingival crevicular fluid interleukin-1β (IL-1β) level and periodontal pathogens', 'Periodontal site-level assessments', 'cause mortality, cardiovascular events, infection events, systemic parameters, and serum biomarkers']","[{'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",11.0,0.0500011,"Comparing to control group, clinical periodontal parameters, gingival crevicular fluid interleukin-1β (IL-1β) level and periodontal pathogens showed significant improvement in the treatment group.","[{'ForeName': 'Wen-Chen', 'Initials': 'WC', 'LastName': 'Chung', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei 110, Taiwan.'}, {'ForeName': 'Chih-Chin', 'Initials': 'CC', 'LastName': 'Kao', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei 110, Taiwan.'}, {'ForeName': 'Chiung-Fang', 'Initials': 'CF', 'LastName': 'Huang', 'Affiliation': 'Division of Family and Operative Dentistry, Department of Dentistry, Taipei Medical University Hospital, Taipei 110, Taiwan.'}, {'ForeName': 'Chang-Yu', 'Initials': 'CY', 'LastName': 'Lee', 'Affiliation': 'Division of Periodontics, Department of Dentistry, Taipei Medical University Hospital, Taipei 110, Taiwan.'}, {'ForeName': 'Hsein-Kun', 'Initials': 'HK', 'LastName': 'Lu', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei 110, Taiwan.'}, {'ForeName': 'Mai-Szu', 'Initials': 'MS', 'LastName': 'Wu', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei 110, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph19031533']
1986,35142560,Effect of an exercise bout before the booster dose of an inactivated SARS-CoV-2 vaccine on immunogenicity in immunocompromised patients.,"This randomized controlled study aimed to investigate whether a single bout of exercise before the homologous booster dose of a SARS-CoV-2 inactivated vaccine could enhance immunogenicity in patients with spondyloarthritis. We selected 60 consecutive patients with spondyloarthritis (SpA). Patients assigned to the intervention group performed an exercise bout comprising three exercises. Then, they remained at rest for 1 h before vaccination. The control group remained at rest before vaccination. Immunogenicity was assessed before (Pre) and 1 mo after (Post) the booster using seropositivity rates of total anti-SARS-CoV-2 S1/S2 IgG, geometric mean titers of anti-S1/S2 IgG (GMT), frequency of neutralizing antibodies (NAb) positivity, and NAb activity. At Pre, 16 patients from the exercise group and 16 patients from the control group exhibited seropositivity for IgG (59% vs. 57.1%), and 1 mo after the booster dose, seropositivity occurred in 96% versus 100% of the cases. Only 10 patients from the exercise group and 12 patients from the control group showed positive NAb serology at Pre (37% vs. 42.8%). One month following the booster, NAb positivity was 96% versus 93%. GMT was comparable between groups at Pre. At Post, GMT increased similarly in both groups. Likewise, NAb activity was similar between groups at Pre and increased similarly in both of them as a result of the booster (47.5% vs. 39.9%). In conclusion, a single bout of exercise did not enhance immunogenicity to a homologous booster dose of an inactivated SARS-CoV-2 vaccine among patients with spondyloarthritis. NEW & NOTEWORTHY  We tested the role of exercise as an adjuvant to a booster of a COVID-19 vaccine. Immunocompromised patients were immunized after an acute bout of exercise or not. Patients exhibited an excellent immunogenicity in response to the booster dose. Exercise did not add to the vaccine effects on IgG or neutralizing antibodies.",2022,"In conclusion, a single bout of exercise did not enhance immunogenicity to a homologous booster dose of an inactivated SARS-CoV-2 vaccine among patients with spondyloarthritis.","['60 consecutive patients with spondyloarthritis (SpA', 'patients with spondyloarthritis', 'Immunocompromised Patients']","['SARS-CoV-2 inactivated vaccine', 'exercise bout comprising three exercises', 'Exercise Bout']","['seropositivity for IgG', 'seropositivity rates of total anti-SARS-CoV-2 S1/S2 IgG, geometric mean titers of anti-S1/S2 IgG (GMT), frequency of neutralizing antibodies (NAb) positivity, and NAb activity', 'GMT', 'Immunogenicity', 'positive NAb serology', 'seropositivity', 'NAb positivity', 'Likewise, NAb activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}]","[{'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}]",60.0,0.0338069,"In conclusion, a single bout of exercise did not enhance immunogenicity to a homologous booster dose of an inactivated SARS-CoV-2 vaccine among patients with spondyloarthritis.","[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Division of Rheumatology, Faculdade de Medicina FMUSP, School of Physical Education and Sport, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Carla G S', 'Initials': 'CGS', 'LastName': 'Saad', 'Affiliation': 'Division of Rheumatology, Faculdade de Medicina, Hospital das Clínicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Sofia M', 'Initials': 'SM', 'LastName': 'Sieczkowska', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Division of Rheumatology, Faculdade de Medicina FMUSP, School of Physical Education and Sport, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ítalo Ribeiro', 'Initials': 'ÍR', 'LastName': 'Lemes', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Division of Rheumatology, Faculdade de Medicina FMUSP, School of Physical Education and Sport, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Rafael Pires', 'Initials': 'RP', 'LastName': 'da Silva', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Division of Rheumatology, Faculdade de Medicina FMUSP, School of Physical Education and Sport, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ana J', 'Initials': 'AJ', 'LastName': 'Pinto', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Division of Rheumatology, Faculdade de Medicina FMUSP, School of Physical Education and Sport, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Bruna C', 'Initials': 'BC', 'LastName': 'Mazzolani', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Division of Rheumatology, Faculdade de Medicina FMUSP, School of Physical Education and Sport, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Fabiana I', 'Initials': 'FI', 'LastName': 'Smaira', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Division of Rheumatology, Faculdade de Medicina FMUSP, School of Physical Education and Sport, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Saulo', 'Initials': 'S', 'LastName': 'Gil', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Division of Rheumatology, Faculdade de Medicina FMUSP, School of Physical Education and Sport, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Gersiel', 'Initials': 'G', 'LastName': 'Oliveira-Junior', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Division of Rheumatology, Faculdade de Medicina FMUSP, School of Physical Education and Sport, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Nadia E', 'Initials': 'NE', 'LastName': 'Aikawa', 'Affiliation': 'Division of Rheumatology, Faculdade de Medicina, Hospital das Clínicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Medeiros-Ribeiro', 'Affiliation': 'Division of Rheumatology, Faculdade de Medicina, Hospital das Clínicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Clovis A', 'Initials': 'CA', 'LastName': 'Silva', 'Affiliation': 'Division of Rheumatology, Faculdade de Medicina, Hospital das Clínicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Emily F N', 'Initials': 'EFN', 'LastName': 'Yuki', 'Affiliation': 'Division of Rheumatology, Faculdade de Medicina, Hospital das Clínicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Sandra G', 'Initials': 'SG', 'LastName': 'Pasoto', 'Affiliation': 'Division of Rheumatology, Faculdade de Medicina, Hospital das Clínicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Rosa Maria R', 'Initials': 'RMR', 'LastName': 'Pereira', 'Affiliation': 'Division of Rheumatology, Faculdade de Medicina, Hospital das Clínicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Samuel K', 'Initials': 'SK', 'LastName': 'Shinjo', 'Affiliation': 'Division of Rheumatology, Faculdade de Medicina, Hospital das Clínicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Danieli C O', 'Initials': 'DCO', 'LastName': 'Andrade', 'Affiliation': 'Division of Rheumatology, Faculdade de Medicina, Hospital das Clínicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Percival D', 'Initials': 'PD', 'LastName': 'Sampaio-Barros', 'Affiliation': 'Division of Rheumatology, Faculdade de Medicina, Hospital das Clínicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Division of Rheumatology, Faculdade de Medicina FMUSP, School of Physical Education and Sport, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Bonfa', 'Affiliation': 'Division of Rheumatology, Faculdade de Medicina, Hospital das Clínicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00015.2022']
1987,34474706,How important is proper dosing for subcutaneous and sublingual allergy immunotherapy?,"Background:  Results of surveys report that allergists use a wide range of doses for allergy immunotherapy; however, results of randomized, double-blind, placebo controlled studies suggest that the range of the optimum effective dosing is relatively narrow.  Objective:  To review studies that established effective or less than fully effective doses for allergy immunotherapy.  Methods:  Studies were reviewed that established effective and ineffective subcutaneous and sublingual immunotherapy doses. Only those studies that expressed dosing in terms of the content of a major allergen in the maintenance doses were included in defining effective and ineffective doses.  Results:  Studies were identified that showed effective doses for subcutaneous injection, established in randomized, double-blind, placebo controlled trials, for short ragweed, timothy grass, house-dust mites, cat and dog dander, birch, and Alternaria. For short ragweed, timothy grass, Dermatophagoides pteronyssinus, and cat and dog dander, less-effective doses were determined, along with effective doses; the less-effective doses were only one-fifth to one-tenth less in allergen content than were the effective doses. Effective doses of cockroach and all fungal extracts except Alternaria have not been established. Information is available on the mean major allergen content of U.S. standardized and a few nonstandardized extracts, which allows the information on effective and ineffective dosing to be used in prescribing subcutaneous allergy immunotherapy. With sublingual allergy immunotherapy, all the approved tablets had multidose studies that determined the optimal dose. For the U.S. liquid extracts, to my knowledge, there are no studies to define effective doses except for ragweed.  Conclusions:  Although a wide range of doses are prescribed by U.S. allergists, analysis of available data suggests that effective doses fall within a narrow range and that use of doses one-fifth or one-tenth of the effective doses may sacrifice most or all of the potential efficacy of the treatment.",2021,"For short ragweed, timothy grass, Dermatophagoides pteronyssinus, and cat and dog dander, less-effective doses were determined, along with effective doses; the less-effective doses were only one-fifth to one-tenth less in allergen content than were the effective doses.",[],"['placebo', 'cockroach', 'allergy immunotherapy']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009208', 'cui_str': 'Cockroach'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]",[],,0.0217836,"For short ragweed, timothy grass, Dermatophagoides pteronyssinus, and cat and dog dander, less-effective doses were determined, along with effective doses; the less-effective doses were only one-fifth to one-tenth less in allergen content than were the effective doses.","[{'ForeName': 'Harold S', 'Initials': 'HS', 'LastName': 'Nelson', 'Affiliation': ''}]",Allergy and asthma proceedings,['10.2500/aap.2021.42.210061']
1988,34788583,Phenotypes of Patients with COVID-19 Who Have a Positive Clinical Response to Helmet Noninvasive Ventilation.,,2022,,['Phenotypes of Patients with COVID-19'],[],[],"[{'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",[],[],,0.0791478,,"[{'ForeName': 'Domenico Luca', 'Initials': 'DL', 'LastName': 'Grieco', 'Affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome, Italy.'}, {'ForeName': 'Luca S', 'Initials': 'LS', 'LastName': 'Menga', 'Affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome, Italy.'}, {'ForeName': 'Melania', 'Initials': 'M', 'LastName': 'Cesarano', 'Affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome, Italy.'}, {'ForeName': 'Savino', 'Initials': 'S', 'LastName': 'Spadaro', 'Affiliation': ""Azienda Ospedaliera-Universitaria di Ferrara Arcispedale Sant'Anna Ferrara, Italy.""}, {'ForeName': 'Maria Maddalena', 'Initials': 'MM', 'LastName': 'Bitondo', 'Affiliation': 'Infermi Hospital Rimini, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Berardi', 'Affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome, Italy.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Rosà', 'Affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Bongiovanni', 'Affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome, Italy.'}, {'ForeName': 'Salvatore Maurizio', 'Initials': 'SM', 'LastName': 'Maggiore', 'Affiliation': ""Gabriele d'Annunzio University of Chieti-Pescara Chieti, Italy.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Antonelli', 'Affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202105-1212LE']
1989,35144238,A social media intervention for cannabis use among emerging adults: Randomized controlled trial.,"PURPOSE


Cannabis use is increasing among emerging adults (ages 18-25), necessitating the need for prevention interventions. Using a novel platform - social media - we developed an 8-week motivational interviewing and cognitive-behavioral intervention targeting cannabis use among emerging adults. Herein, we report on the feasibility and acceptability of the intervention in a pilot trial.
PROCEDURES


For NCT04187989 we recruited N = 149 emerging adults who used cannabis (at least 3 times/week for the past month) using social media advertising. Their mean age was 21.0 years (SD = 2.2); 55.7% were female. Most were White (70.5%; 20.1% Black/African American, 9.4% Other races), with 20.1% identifying as Hispanic/Latinx. Participants were randomized to the 8-week intervention or an 8-week attention-placebo control condition, both delivered in secret Facebook groups by electronic health coaches (e-coaches). Follow-up assessments occurred at 3- and 6-months.
RESULTS


The intervention was well-received and follow-up rates were high; fidelity was good. Intervention participants rated e-coaches significantly higher in terms of helpfulness, warmth, etc., compared to control participants. Intervention participants were more likely to engage with and recommend the group. In terms of percentage reductions in cannabis outcomes, the intervention group evidenced absolute reductions over time in several measures of cannabis consumption across modalities. In an adjusted model, reductions in vaping days in the intervention group, relative to attention-control, reached statistical significance (p = .020, D =.40).
CONCLUSIONS


This social media intervention for emerging adults' cannabis use was feasible and acceptable in the target population warranting future testing in a fully powered trial.",2022,"In terms of percentage reductions in cannabis outcomes, the intervention group evidenced absolute reductions over time in several measures of cannabis consumption across modalities.","['adults (ages 18-25', 'cannabis use among emerging adults', 'recruited N\xa0=\xa0149 emerging adults who used cannabis (at least 3 times/week for the past month) using social media advertising', 'Their mean age was 21.0 years (SD = 2.2); 55.7% were female']","['novel platform - social media - we developed an 8-week motivational interviewing and cognitive-behavioral intervention', 'social media intervention', '8-week attention-placebo control condition, both delivered in secret Facebook groups by electronic health coaches']",['feasibility and acceptability'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",149.0,0.0230393,"In terms of percentage reductions in cannabis outcomes, the intervention group evidenced absolute reductions over time in several measures of cannabis consumption across modalities.","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI 48109, USA; Injury Prevention Center, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI 48109, USA; Center for Sexuality and Health Disparities, University of Michigan, 400 North Ingalls Street, Ann Arbor, MI 48109, USA. Electronic address: erinbona@med.umich.edu.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Goldstick', 'Affiliation': 'Injury Prevention Center, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI 48109, USA; Department of Emergency Medicine, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI 48109, USA; Department of Health Behavior and Health Education, School of Public Health, University of Michigan, 1415 Washington Heights, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Lyndsay', 'Initials': 'L', 'LastName': 'Chapman', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Bauermeister', 'Affiliation': 'Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Young', 'Affiliation': 'Department of Informatics, Donald Bren School of Information and Computer Sciences, University of California Irvine, Irvine, CA 92697, USA; Department of Emergency Medicine, School of Medicine, University of California Irvine, Irvine, CA 92697, USA.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'McAfee', 'Affiliation': 'Department of Anesthesiology, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 16, Ann Arbor, MI 48109, USA; Injury Prevention Center, University of Michigan, North Campus Research Complex, 2800 Plymouth Rd. Building 10, Ann Arbor, MI 48109, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2022.109345']
1990,35144225,"Invitations, incentives, and conditions: A randomized evaluation of demand-side interventions for health screenings.","This randomized controlled trial investigates the impact of four demand-side interventions on health screening for diabetes and hypertension among Armenian adults. The interventions are 1) personalized invitations from a physician, 2) personalized invitations with information about peer screening behavior, 3) personalized invitations with a labeled but unconditional financial incentive, and 4) personal invitations with a conditional financial incentive. Compared with the control group, interventions 1 to 3 led to a significant increase in the screening rate of about 15 percentage points for diabetes and hypertension. The highest impact was measured for intervention 4 leading to a 31.2 percentage point increase in both screenings.",2022,"Compared with the control group, interventions 1 to 3 led to a significant increase in the screening rate of about 15 percentage points for diabetes and hypertension.","['health screenings', 'diabetes and hypertension among Armenian adults']","['four demand-side interventions', 'demand-side interventions', 'personalized invitations from a physician, 2) personalized invitations with information about peer screening behavior, 3) personalized invitations with a labeled but unconditional financial incentive, and 4) personal invitations with a conditional financial incentive']",['screening rate'],"[{'cui': 'C0220908', 'cui_str': 'Screening procedure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0003799', 'cui_str': 'Armenian language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",,0.0433161,"Compared with the control group, interventions 1 to 3 led to a significant increase in the screening rate of about 15 percentage points for diabetes and hypertension.","[{'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'de Walque', 'Affiliation': 'The World Bank, USA. Electronic address: ddewalque@worldbank.org.'}, {'ForeName': 'Adanna', 'Initials': 'A', 'LastName': 'Chukwuma', 'Affiliation': 'The World Bank, USA. Electronic address: achukwuma@worldbank.org.'}, {'ForeName': 'Nono', 'Initials': 'N', 'LastName': 'Ayivi-Guedehoussou', 'Affiliation': 'The World Bank, USA. Electronic address: nonoayivi@worldbank.org.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Koshkakaryan', 'Affiliation': 'The World Bank, USA. Electronic address: mkoshkakaryan@worldbank.org.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2022.114763']
1991,35145209,Five-year outcomes of premature infants randomized to high or standard loading dose caffeine.,"OBJECTIVE


To examine 5-year outcomes in children enrolled in a pilot randomized controlled trial of a high loading dose of caffeine after preterm birth.
STUDY DESIGN


Seventy-four very low birth weight neonates were randomized within the first 24 h of life to receive a high (80 mg/kg) or standard (20 mg/kg) loading dose of caffeine citrate. At 5 years of age, we conducted standardized neurodevelopmental tests and collected parent reports of child socioemotional problems.
RESULT


Seventy-four percent of survivors returned for follow up. Children obtained similar scores on neurodevelopmental and socioemotional evaluations. There was no difference in the incidence of any neurodevelopmental delay after controlling for confounding factors.
CONCLUSION


Five-year follow up of a pilot trial of high loading dose caffeine citrate documented no profound impacts on childhood neurodevelopment or socioemotional outcome.",2022,Five-year follow up of a pilot trial of high loading dose caffeine citrate documented no profound impacts on childhood neurodevelopment or socioemotional outcome.,"['children enrolled', 'Seventy-four very low birth weight neonates']","['caffeine', 'standard loading dose caffeine', 'caffeine citrate']","['childhood neurodevelopment or socioemotional outcome', 'incidence of any neurodevelopmental delay']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0054436', 'cui_str': 'Caffeine citrate'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",74.0,0.166757,Five-year follow up of a pilot trial of high loading dose caffeine citrate documented no profound impacts on childhood neurodevelopment or socioemotional outcome.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McPherson', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis, St. Louis, MO, USA. mcphersonc@wustl.edu.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Lean', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Peppar E P', 'Initials': 'PEP', 'LastName': 'Cyr', 'Affiliation': 'Department of Neurology, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Terrie E', 'Initials': 'TE', 'LastName': 'Inder', 'Affiliation': ""Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Cynthia E', 'Initials': 'CE', 'LastName': 'Rogers', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Smyser', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis, St. Louis, MO, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-022-01333-5']
1992,35145610,"Comparing meditative scuba diving versus multisport activities to improve post-traumatic stress disorder symptoms: a pilot, randomized controlled clinical trial.","Background


Post-Traumatic Stress Disorder (PTSD) is a chronic and disabling disease that currently has no fully effective therapeutic solution. Complementary approaches, such as relaxation, sport, or meditation, could be therapeutic aids for symptom reduction. Scuba diving combines sport and mindfulness training and has been found to have a positive effect on chronic stress and PTSD.
Objectives


The first objective of this pilot study is to compare the effectiveness of diving associated with mindfulness exercises (the Bathysmed® protocol) with multisport activity in reducing PTSD symptoms. The secondary objective is to compare the impact of the Bathysmed® protocol on mindfulness functioning in the two groups of subjects suffering from PTSD.
Method


This proof-of-concept took the form of a controlled randomized clinical trial. The primary endpoint was the severity of PTSD symptoms, measured by the PCL-5 (PTSD Check List) scale. Half of the group were exposed to the Bathysmed® protocol (the experimental condition), and the other half to a non-specific multisport program.
Results


Bathysmed® protocol improved PCL-5 scores more than the multisport program but the result was not significant. The protocol was significantly better than the multisport activity in reducing intrusion symptoms of PTSD after one month. Globally, trait mindfulness scores improved up to one month after the course, but the result was not significant. Three months after the course, there was no difference between the two groups with regard to PCL-5 and Freiburg Mindfulness Inventory scores..
Conclusion


Our study demonstrates the value of the Bathysmed® protocol even though it suffers from a lack of power and could only obtain partial but encouraging results. Mindfulness must be practiced over the long term to achieve stable benefits. This probably explains why no differences persisted three months after the course. Further work is needed to confirm the initial results obtained with this pilot study.",2022,Bathysmed® protocol improved PCL-5 scores more than the multisport program but the result was not significant.,"['subjects suffering from PTSD', 'post-traumatic stress disorder symptoms']","['mindfulness exercises (the Bathysmed® protocol) with multisport activity', 'Scuba diving combines sport and mindfulness training', 'meditative scuba diving versus multisport activities', 'Bathysmed® protocol']","['severity of PTSD symptoms, measured by the PCL-5 (PTSD Check List) scale', 'PTSD symptoms', 'PCL-5 and Freiburg Mindfulness Inventory scores', 'intrusion symptoms of PTSD', 'trait mindfulness scores', 'PCL-5 scores']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0240984', 'cui_str': 'Scuba diving'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704423', 'cui_str': 'Hereditary lymphedema'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0297734,Bathysmed® protocol improved PCL-5 scores more than the multisport program but the result was not significant.,"[{'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Gibert', 'Affiliation': 'PsycoMadd, Université Paris Saclay, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Coulange', 'Affiliation': 'Service de Médecine Hyperbare, Subaquatique Et Maritime, Assistance Publique Des Hôpitaux de Marseille, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Reynier', 'Affiliation': 'Service de Médecine Hyperbare, Subaquatique Et Maritime, Assistance Publique Des Hôpitaux de Marseille, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Le Quiniat', 'Affiliation': 'Service de Médecine Hyperbare, Subaquatique Et Maritime, Assistance Publique Des Hôpitaux de Marseille, France.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Molle', 'Affiliation': 'Stress neurophysiology, French Armed Forces Biomedical Research Institute, Brétigny-sur-Orge, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Bénéton', 'Affiliation': 'Diving department, Bathysmed, Bouillante, Guadeloupe.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Meurice', 'Affiliation': 'Diving department, Bathysmed, Bouillante, Guadeloupe.'}, {'ForeName': 'Jean Arthur', 'Initials': 'JA', 'LastName': 'Micoulaud', 'Affiliation': 'Sleep medicine, Services Universitaire de Médecine du Sommeil, Sums, Chu de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Trousselard', 'Affiliation': 'Stress neurophysiology, French Armed Forces Biomedical Research Institute, Brétigny-sur-Orge, France.'}]",European journal of psychotraumatology,['10.1080/20008198.2022.2031590']
1993,35146942,A pilot randomized trial of simplified versus standard calorie dietary self-monitoring in a mobile weight loss intervention.,"OBJECTIVE


This study tested the efficacy of a lower-burden, simplified dietary self-monitoring approach compared with a standard calorie monitoring approach for self-monitoring adherence and weight loss in a mobile-delivered behavioral weight loss intervention.
METHODS


Participants (n = 72) with overweight or obesity who had children 2 to 12 years of age living in the home were randomly assigned to a group that used simplified dietary self-monitoring of high-calorie foods (Simplified) or a group that tracked calories (Standard). Both groups received a wireless scale, Fitbit trackers, and a 6-month intervention delivered via a smartphone application with lessons, text messages, and weekly personalized feedback messages.
RESULTS


Percentage weight loss at 6 months was 5.7% (95% CI: -8.3% to -3.2%) in the Standard group and 4.0% (95% CI: -5.7% to -2.3%) in the Simplified group, which was not significantly different. Similar proportions reached 5% weight loss at 6 months (43.2% in Standard and 42.9% in Simplified). There were no differences in number of dietary tracking days or change in average daily caloric intake between groups.
CONCLUSIONS


Two mobile-delivered weight loss interventions produced clinically meaningful levels of weight loss at 6 months, with no differences in dietary tracking adherence or dietary intake. The results suggest that simplified monitoring of high-calorie foods could be a promising alternative to calorie monitoring.",2022,"RESULTS


Percentage weight loss at 6 months was 5.7% (95% CI: -8.3% to -3.2%) in the Standard group and 4.0% (95% CI: -5.7% to -2.3%) in the Simplified group, which was not significantly different.",['Participants (n = 72) with overweight or obesity who had children 2 to 12 years of age living in the home'],"['simplified versus standard calorie dietary self-monitoring', 'standard calorie monitoring approach', 'simplified dietary self-monitoring of high-calorie foods (Simplified) or a group that tracked calories (Standard', 'wireless scale, Fitbit trackers, and a 6-month intervention delivered via a smartphone application with lessons, text messages, and weekly personalized feedback messages']","['number of dietary tracking days or change in average daily caloric intake', 'weight loss', 'dietary tracking adherence or dietary intake']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0453831', 'cui_str': 'High energy food'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",72.0,0.0167521,"RESULTS


Percentage weight loss at 6 months was 5.7% (95% CI: -8.3% to -3.2%) in the Standard group and 4.0% (95% CI: -5.7% to -2.3%) in the Simplified group, which was not significantly different.","[{'ForeName': 'Brooke T', 'Initials': 'BT', 'LastName': 'Nezami', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Lex', 'Initials': 'L', 'LastName': 'Hurley', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Power', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Carmina G', 'Initials': 'CG', 'LastName': 'Valle', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Deborah F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.23377']
1994,35149326,"Effect of zinc supplementation on circulating concentrations of homocysteine, vitamin B 12 , and folate in a postmenopausal population.","INTRODUCTION


The decrease in estrogen levels associated with menopause increases the risk of deficiencies of key micronutrients such as zinc and of disturbances in methylation cycle-related markers. The present study assesses the effect of 8-week Zn supplementation upon circulating concentrations of Hcy, B 12 , and Fol levels in a population of postmenopausal women.
METHODS


Fifty-one postmenopausal women aged between 44 and 76 years took part in the study. Two randomized groups (placebo and zinc [50 mg/day]) were treated during 8 weeks. Nutrient intake was assessed based on the 72-hour recall method. Zinc was analyzed by flame atomic absorption spectrophotometry. Clinical-nutritional parameters were determined by enzyme immunoassay techniques.
RESULTS


Folate levels increased significantly (p < 0.05) in the zinc group on comparing the baseline versus follow-up values. Homocysteine decreased in the inter-group analysis (p < 0.05) after the intervention. Furthermore, higher folate (r = -0.632; p = 0.005) and vitamin B 12  (r = -0.512; p = 0.030) levels were correlated to low homocysteine levels in the zinc group after the intervention, although the zinc intervention had the same effect on B 12  levels in both groups.
CONCLUSION


Zinc supplementation enhanced circulating folate and homocysteine by improving the folate values in the zinc-supplemented group and decreasing homocysteine levels inter-groups. Further studies involving larger samples and optimizing the doses and intervention period are needed to reinforce our main findings.",2022,"RESULTS


Folate levels increased significantly (p < 0.05) in the zinc group on comparing the baseline versus follow-up values.","['Fifty-one postmenopausal women aged between 44 and 76 years took part in the study', 'population of postmenopausal women', 'postmenopausal population']","['zinc supplementation', '8-week Zn supplementation', 'placebo and zinc', 'Zinc supplementation']","['low homocysteine levels', 'homocysteine levels', 'estrogen levels', 'Homocysteine', 'circulating folate and homocysteine', 'circulating concentrations of Hcy, B 12 , and Fol levels', 'Folate levels', 'circulating concentrations of homocysteine, vitamin B 12 , and folate', 'Nutrient intake', 'folate values']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",51.0,0.0464473,"RESULTS


Folate levels increased significantly (p < 0.05) in the zinc group on comparing the baseline versus follow-up values.","[{'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Vázquez-Lorente', 'Affiliation': 'Department of Physiology, School of Pharmacy, Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, 18071 Granada, Spain. Electronic address: hectorvazquez@ugr.es.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Herrera-Quintana', 'Affiliation': 'Department of Physiology, School of Pharmacy, Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, 18071 Granada, Spain. Electronic address: lourdesherrera@ugr.es.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Molina-López', 'Affiliation': 'Faculty of Education, Psychology and Sports Sciences, University of Huelva, 21007 Huelva, Spain. Electronic address: jorge.molina@ddi.uhu.es.'}, {'ForeName': 'Yenifer', 'Initials': 'Y', 'LastName': 'Gamarra', 'Affiliation': 'Department of Physiology, School of Pharmacy, Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, 18071 Granada, Spain. Electronic address: jennifer.gamarra.sspa@juntadeandalucia.es.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Planells', 'Affiliation': 'Department of Physiology, School of Pharmacy, Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, 18071 Granada, Spain. Electronic address: elenamp@ugr.es.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2022.126942']
1995,35149656,Nurse-Led Telephonic Palliative Care: A Case-Based Series of a Novel Model of Palliative Care Delivery.,"Americans near the end of life experience high rates of nonbeneficial, burdensome, and preventable hospital-based care. If patients' goals of care are unknown or unclear, they have higher rates of hospitalization at the end of life. The demand for palliative care has grown exponentially because of its impact on quality of life, symptom burden, and resource use, requiring the development of new palliative care models. Nurses' holistic outlook and patient-centered focus make them ideal to deliver telephonic palliative care. This article discusses 4 cases delivered by a nurse-led telephonic palliative care program, a part of the Emergency Medicine Palliative Care Access project, which is a randomized controlled trial comparing outpatient palliative care with nurse-led telephonic case management after an emergency department visit. Telephonic nurses discuss patients' goals, fears, hopes, and concerns regarding their illness and its trajectory that inform decisions for future interventions and treatments. In addition, they share this information with the patients' surrogate decision-makers and clinicians to facilitate care coordination and symptom management. For seriously ill patients, nurses' abilities and expertise, as well as the difficulties of providing care through in-person models of palliative care delivery, make a nurse-led telephonic model an optimal option.",2022,"The demand for palliative care has grown exponentially because of its impact on quality of life, symptom burden, and resource use, requiring the development of new palliative care models.",[],['Nurse-Led Telephonic Palliative Care'],[],[],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]",[],,0.035866,"The demand for palliative care has grown exponentially because of its impact on quality of life, symptom burden, and resource use, requiring the development of new palliative care models.","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Yamarik', 'Affiliation': ''}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Abraham A', 'Initials': 'AA', 'LastName': 'Brody', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Curtis', 'Affiliation': ''}, {'ForeName': 'Laraine', 'Initials': 'L', 'LastName': 'Chiu', 'Affiliation': ''}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bouillon-Minois', 'Affiliation': ''}, {'ForeName': 'Corita R', 'Initials': 'CR', 'LastName': 'Grudzen', 'Affiliation': ''}]",Journal of hospice and palliative nursing : JHPN : the official journal of the Hospice and Palliative Nurses Association,['10.1097/NJH.0000000000000850']
1996,35031522,"Obstetrical randomized controlled trials: individuals screened, approached, and enrolled.","BACKGROUND


The use of randomized clinical trials (RCTs) is predicated on the idea that the study group is representative of the overall clinical population; however, recent studies have suggested that this may not be the case in obstetrics. 1 , 2  The generalizability of several seminal obstetrical RCTs, including the A Randomized Trial of Induction Versus Expectant Management trial, has been questioned because of the high ratio of assessed-to-enrolled individuals. 3  Although difficulty in recruitment for obstetrical RCTs is known, 4  it has been postulated that this high ratio increases the likelihood of the study population not being truly representative. Our primary objective was to analyze the assessed-to-enrolled ratio in contemporary obstetrical RCTs.
STUDY DESIGN


During a 4-year period (January 2017 to December 2020), we identified all obstetrical RCTs published in 6 journals (The New England Journal of Medicine, Journal of the American Medical Association, Lancet, American Journal of Obstetrics & Gynecology, British Journal of Obstetrics and Gynaecology, and Obstetrics & Gynecology). The journals were manually reviewed by 2 coauthors to ensure all obstetrical RCTs were identified and abstracted accurately. Reported patient recruitment data, per Consolidated Standards of Reporting Trials recommendations, 5  were abstracted from each RCT. Based on the primary outcome of the study, the purpose of the trial was categorized as preventative or treatment. Medians were compared using Wilcoxon rank-sum testing, and P<.05 was considered significant.
RESULTS


Of 240 obstetrical RCTs that were identified, 193 (80%) reported data on the number of individuals screened and recruited. The median number of individuals screened per trial was 850 (interquartile range [IQR], 323-2582), of which 348 were eligible (IQR, 201-1347) and 300 (IQR, 133-894) were randomized. There was no difference in trials based internationally or in the United States (P=.26). Compared with preventative RCTs, the trials that had treatment as the primary outcome were significantly more likely to screen a larger number of individuals for eligibility (P<.01) and subsequently randomize (P<.02). There was no difference in the median number of individuals who declined enrollment between trials with prevention or treatment as their objective (P=.12). More individuals were lost to follow-up in trials with prevention as the primary outcome (P<.01), although the median number lost was low at 3 (IQR, 0-21).
CONCLUSION


The low assessed-to-enrolled ratio found in this study suggested that researchers are casting a large net for patient recruitment. The relatively high eligible-to-randomized ratio suggested that most individuals are willing to participate in obstetrical RCTs. This finding was at odds with previous critiques of obstetrical RCTs that had called in to question study results secondary to high eligible-to-randomized ratios. Further research into how patients are recruited and counseled is indicated, to explore this variation. The ratio of patients assessed for study eligibility to patients enrolled in preventative vs treatment RCTs was not substantially different. Based on this result, patients seemed to be similarly interested in being enrolled to prevent a complication from pregnancy as in treating one. These results supported the concept that most individuals in the obstetrical RCTs represent the eligible population.",2022,"More individuals were lost to follow-up in trials with prevention as the primary outcome (P<.01), although the median number lost was low at 3 (IQR, 0-21).
","['median number of individuals screened per trial was 850 (interquartile range [IQR], 323-2582), of which 348 were eligible (IQR, 201-1347) and 300 (IQR, 133-894) were randomized']",[],['median number lost'],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517563', 'cui_str': '133'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",5.0,0.423183,"More individuals were lost to follow-up in trials with prevention as the primary outcome (P<.01), although the median number lost was low at 3 (IQR, 0-21).
","[{'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Ditter', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Ellen H', 'Initials': 'EH', 'LastName': 'Crowe', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Mendez-Figueroa', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Michal Fishel', 'Initials': 'MF', 'LastName': 'Bartal', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': 'Department of Obstetrics and Gynecology, Alpert Medical School, Brown University, 101 Dudley St., Providence, RI 02905. Electronic address: stephen_wagner@brown.edu.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100564']
1997,35098587,SLC6A3 gene polymorphisms are associated with striatal dopamine transporter changes after glucose loading.,"We investigated the association between SLC6A3 gene polymorphisms and changes in dopamine transporter (DAT) availability after glucose loading in humans. An intravenous injection of  18  F-FP-CIT was administered after infusion of glucose or placebo, and the emission data were acquired over 90 min in 38 healthy male participants. DAT availability expressed in terms of binding potential (BP ND  ) was recorded. The 40-bp variable number of tandem repeats (VNTR) in the 3' untranslated region and two single nucleotide polymorphisms (SNPs), rs2652511 and rs2937639, in the SLC6A3 gene were genotyped. Among the 38 participants, those with a VNTR other than 10R/10R (n = 7) were excluded. The alleles of the two SNPs (rs2652511 and rs2937639) appeared to be inherited together in two fixed combinations (C-G or T-A) in 29 of 31 individuals. The BP ND  in the ventral striatum (VST), caudate nucleus, and putamen was not significantly different after glucose or placebo loading according to genotype. However, BP ND  s from the caudate nucleus and putamen of all participants with rs2652511 CT/rs2937639 AG (n = 6) were higher after glucose loading. In conclusion, the SLC6A3 gene polymorphism is associated with the changes in DAT availability after glucose loading. DAT availability after glucose or placebo loading in the VST, caudate nucleus, and putamen did not differ according to the SLC6A3 genotype.",2022,"The BP ND  in the ventral striatum (VST), caudate nucleus, and putamen was not significantly different after glucose or placebo loading according to genotype.","['38 participants, those with a VNTR other than 10R/10R (n\xa0=\xa07) were excluded', '38 healthy male participants', 'humans']",['glucose or placebo'],['DAT availability'],"[{'cui': 'C0242827', 'cui_str': 'Minisatellites'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0114838', 'cui_str': 'Dopamine Transporter'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",38.0,0.135526,"The BP ND  in the ventral striatum (VST), caudate nucleus, and putamen was not significantly different after glucose or placebo loading according to genotype.","[{'ForeName': 'Kyoungjune', 'Initials': 'K', 'LastName': 'Pak', 'Affiliation': 'Department of Nuclear Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Seongho', 'Initials': 'S', 'LastName': 'Seo', 'Affiliation': 'Department of Electronic Engineering, Pai Chai University, Daejeon, Republic of Korea.'}, {'ForeName': 'Keunyoung', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Nuclear Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Myung Jun', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'In Joo', 'Initials': 'IJ', 'LastName': 'Kim', 'Affiliation': 'Department of Nuclear Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.'}]","Synapse (New York, N.Y.)",['10.1002/syn.22223']
1998,35151715,Two-fraction stereotactic ablative radiotherapy (SABR) versus two-fraction high dose rate (HDR) brachytherapy for localized prostate cancer: Does dose heterogeneity matter?,"BACKGROUND AND PURPOSE


Contemporary radiotherapy for localized prostate cancer (PCa) is deliverable via stereotactic ablative radiotherapy (SABR) and high dose rate (HDR) brachytherapy. Here we report on a parallel cohort analysis of two prospective, phase II clinical trials of two-fraction prostate SABR versus two-fraction HDR monotherapy.
MATERIALS AND METHODS


Enrolled patients had histologically-confirmed PCa (clinical stage T1c-T2b; grade group 1, 2, or 3; and PSA < 20 ng/mL). SABR and HDR doses were 26 Gy and 27 Gy in 2 weekly fractions, respectively. Patient-level data from each cohort was analysed to assess prostate specific antigen (PSA) response kinetics, biochemical failure, toxicity, and quality of life (QOL).
RESULTS


Thirty patients receiving SABR and 83 receiving HDR were included. Fifty percent and 30% of patients had unfavourable-intermediate risk disease, respectively. SABR patients had higher mean baseline PSA (8.7 versus 6.8 ng/mL, p = 0.016). Median follow-up was 72.7 and 65.3 months, respectively. Mean dose delivered (D mean ) was 26.6-26.8 Gy for SABR versus 35.5-45.5 Gy for HDR. Both cohorts achieved a median nadir PSA of 0.16 ng/mL at a median of 57 months post-treatment. Cumulative biochemical failure probability (±SE) at 72 months was 3.5% (±3.5%) for SABR versus 12.8% (±4.8%) for HDR (p = 0.19). Low rates of CTCAE grade ≥2 toxicity were observed in both cohorts. No differences in EPIC scores over time were observed between cohorts.
CONCLUSIONS


Two-fraction SABR yields similar rates of biochemical failure, acute and late toxicities, and QOL as two-faction HDR brachytherapy. These data support the design of a randomized controlled trial comparing these treatments.",2022,"SABR patients had higher mean baseline PSA (8.7 versus 6.8 ng/mL, p=0.016).","['Enrolled patients had histologically-confirmed PCa (clinical stage T1c-T2b; grade group 1, 2, or 3; and PSA <20 ng/mL', 'Thirty patients receiving SABR and 83 receiving HDR were included', 'localized prostate cancer (PCa', 'localized prostate cancer']","['Two-fraction stereotactic ablative radiotherapy (SABR) versus two-fraction high dose rate (HDR) brachytherapy', 'fraction prostate SABR versus two-fraction HDR monotherapy', 'stereotactic ablative radiotherapy (SABR) and high dose rate (HDR) brachytherapy']","['biochemical failure, acute and late toxicities, and QOL', 'Low rates of CTCAE grade≥2 toxicity', 'mean baseline PSA', 'EPIC scores', 'median nadir PSA', 'prostate specific antigen (PSA) response kinetics, biochemical failure, toxicity, and quality of life (QOL', 'Cumulative biochemical failure probability (±SE']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0475386', 'cui_str': 'Tumor stage T1c'}, {'cui': 'C0475388', 'cui_str': 'Tumor stage T2b'}, {'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.123803,"SABR patients had higher mean baseline PSA (8.7 versus 6.8 ng/mL, p=0.016).","[{'ForeName': 'Rohann J M', 'Initials': 'RJM', 'LastName': 'Correa', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Canada.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Morton', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Canada.'}, {'ForeName': 'Hans T', 'Initials': 'HT', 'LastName': 'Chung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Canada.'}, {'ForeName': 'Chia-Lin', 'Initials': 'CL', 'LastName': 'Tseng', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cheung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Canada.'}, {'ForeName': 'Stanley K', 'Initials': 'SK', 'LastName': 'Liu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Canada.'}, {'ForeName': 'Merrylee', 'Initials': 'M', 'LastName': 'McGuffin', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Canada.'}, {'ForeName': 'Anam', 'Initials': 'A', 'LastName': 'Shahid', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Molli Surgical, Princess Margaret Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Helou', 'Affiliation': 'Department of Radiation Oncology, University of Toronto, Canada; Department of Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Alayed', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Radiation Oncology, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mamedov', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Canada; Department of Health Policy, Measurement and Evaluation, University of Toronto, Canada. Electronic address: andrew.loblaw@sunnybrook.ca.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2022.02.007']
1999,35152055,The effect of mode of presentation on Tower of Hanoi problem solving.,"The Tower of Hanoi (TOH) is a classic problem that can be solved via multiple strategies. This study used TOH to examine how mode of presentation of a problem influences strategy use and transfer. Undergraduate students (Experiment 1) or Prolific workers (Experiment 2) completed two TOH problems of varying difficulty (4-disk/5-disk). They were randomly assigned to different conditions in which problems were either high in internal representation (mental) or high in external representation (computer). Participants were better able to complete problems successfully when external representations were available but completed problems in fewer moves when relying on internal representations. In addition, participants spent more time between moves when solving problems mentally, suggesting that external representations encourage speed while internal representations promote accuracy when solving recursion problems. Lastly, both experiments provide evidence that first solving a problem mentally encouraged participants to use strategies similar to goal recursion on a second problem.",2022,Participants were better able to complete problems successfully when external representations were available but completed problems in fewer moves when relying on internal representations.,['Undergraduate students (Experiment 1) or Prolific workers (Experiment 2) completed two TOH problems of varying difficulty (4-disk/5-disk'],['high in internal representation (mental) or high in external representation (computer'],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0009622', 'cui_str': 'Computer'}]",[],,0.0146368,Participants were better able to complete problems successfully when external representations were available but completed problems in fewer moves when relying on internal representations.,"[{'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Fansher', 'Affiliation': 'University of Michigan, United States of America. Electronic address: mfansher@umich.edu.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'University of Michigan, United States of America.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Hélie', 'Affiliation': 'Purdue University, United States of America.'}]",Cognition,['10.1016/j.cognition.2022.105041']
2000,35152036,Mediators and moderators of outcome from the Transdiagnostic Sleep and Circadian Intervention for adults with severe mental illness in a community setting.,"This study explores mediators and moderators of outcome from the Transdiagnostic Sleep and Circadian Intervention (TranS-C). Participants were 121 adults (age mean [SD] = 45.45 [13.25] years; 52.06% female), with severe mental illness and sleep and circadian dysfunction. They were randomized to receive TranS-C and usual care, or usual care followed by delayed TranS-C. Putative mediators were the PROMIS-Sleep Disturbance Scale, PROMIS-Sleep-Related Impairment Scale, and the Sleep Health Composite. Putative moderators were symptom severity at baseline, age, housing environment, race and ethnicity. Mediation analysis indicated that changes in sleep-related impairment and sleep health, but not sleep disturbance, mediate TranS-C's effect on functional impairment (CI: [-0.28,-0.07] and [-0.18,-0.08], respectively) and general psychiatric symptoms (CI [-0.30,-0.06] and [-0.20,-0.02]) post-treatment, though mediation via sleep health was not maintained through 6-month follow up. Moderation analysis indicated that those with severe sleep-related symptoms at baseline and Black/African American individuals are particularly responsive to TranS-C, whereas older recipients had a poorer response. TranS-C reduces functional impairment and general psychiatric symptoms amongst adults with SMI by reducing sleep-related impairment and improving sleep health. Selected sleep outcomes of TranS-C are strongest among Black/African Americans and those with severe sleep problems, and weakest among older adults.",2022,TranS-C reduces functional impairment and general psychiatric symptoms amongst adults with SMI by reducing sleep-related impairment and improving sleep health.,"['Participants were 121 adults (age mean [SD] = 45.45 [13.25] years; 52.06% female), with severe mental illness and sleep and circadian dysfunction', 'adults with SMI', 'Black/African Americans and those with severe sleep problems, and weakest among older adults', 'adults with severe mental illness in a community setting']","['TranS-C', 'TranS-C and usual care, or usual care followed by delayed TranS-C. Putative mediators', 'Transdiagnostic Sleep and Circadian Intervention (TranS-C', 'Transdiagnostic Sleep and Circadian Intervention']","['general psychiatric symptoms', 'PROMIS-Sleep Disturbance Scale, PROMIS-Sleep-Related Impairment Scale, and the Sleep Health Composite', 'sleep-related impairment and sleep health']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",121.0,0.043819,TranS-C reduces functional impairment and general psychiatric symptoms amongst adults with SMI by reducing sleep-related impairment and improving sleep health.,"[{'ForeName': 'Courtney C', 'Initials': 'CC', 'LastName': 'Armstrong', 'Affiliation': 'University of California, Berkeley, CA, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'University of California, Berkeley, CA, USA; RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'University of California, Berkeley, CA, USA. Electronic address: aharvey@berkeley.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2022.104053']
2001,35151982,Cybersickness and postural stability of first time VR users playing VR videogames.,"This study investigated symptoms of cybersickness and postural instability experienced by new users of head-mounted display virtual reality (HMD-VR), playing VR videogames over long and repeated sessions, and moderation of these symptoms by previous videogame experience and intensity of videogame stimulus. Cybersickness (SSQ) and postural stability (anterior-posterior path-velocity) of new users of VR (n = 80) was collected PRE-VR, POST-VR and 10 min after completing (POST-RECOVERY) a VR gaming experience. Users comprised of videogamers (n = 40) and non-videogamers (n = 40), who were randomly assigned to play either action (high-intensity stimuli) or adventure (low-intensity stimuli) games in VR for 30 min and repeated twice, one week apart. All participants, irrespective of gaming status and genre of game, experienced significant cybersickness after 30 min in VR using current-generation HMD-VR technology, and did not adapt (POST-VR) after two sessions. However videogamers were able to recover (POST-RECOVERY) from cybersickness induced in VR significantly better than non-videogamers. All participants experienced significantly better postural stability after 30 min in VR, irrespective of gaming experience or genre of game. Developers should create VR experiences that minimise negative symptoms of cybersickness and postural instability experience by new users of VR.",2022,Developers should create VR experiences that minimise negative symptoms of cybersickness and postural instability experience by new users of VR.,['Users comprised of videogamers (n\xa0=\xa040) and non-videogamers (n\xa0=\xa040'],"['head-mounted display virtual reality (HMD-VR), playing VR videogames', 'play either action (high-intensity stimuli) or adventure (low-intensity stimuli) games in VR']","['Cybersickness and postural stability', 'Cybersickness (SSQ) and postural stability (anterior-posterior path-velocity', 'postural stability']",[],"[{'cui': 'C5197728', 'cui_str': 'Head Worn Display'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",,0.0243516,Developers should create VR experiences that minimise negative symptoms of cybersickness and postural instability experience by new users of VR.,"[{'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'da Silva Marinho', 'Affiliation': 'School of Law and Society, University of the Sunshine Coast, Maroochydore DC, Queensland, 4558, Australia.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Terton', 'Affiliation': 'Faculty of Business, Law and Arts, Southern Cross University, Military Road, East Lismore, NSW, 2480, Australia.'}, {'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Jones', 'Affiliation': 'School of Law and Society, University of the Sunshine Coast, Maroochydore DC, Queensland, 4558, Australia. Electronic address: cmjones@usc.edu.au.'}]",Applied ergonomics,['10.1016/j.apergo.2022.103698']
2002,33714571,"Introduction: Re-intervention for bioprosthetic valve failure: Is less more, or just less?",,2022,,['bioprosthetic valve failure'],[],[],"[{'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",[],[],,0.0858539,,"[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, Medical College of Georgia, Augusta University, Augusta, Ga. Electronic address: RICKLEE@augusta.edu.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2021.01.119']
2003,35162750,Multicomponent Aquatic Training (MAT) Program for People with Parkinson's Disease: A Protocol for a Controlled Study.,"INTRODUCTION


The complications from Parkinson's disease (PD) are directly related to decreased muscle function, balance deficits, and independence loss. Practicing aquatic exercises can minimize these symptoms and slow disease progress.
OBJECTIVE


To develop a Multicomponent Aquatic Training (MAT) protocol for people with PD between stages 1 and 4 of the Hoehn and Yahr scale.
METHODS


The protocol is for a single blind controlled clinical trial. The sample will comprise of people with PD between stages 1 and 4 in Hoehn and Yahr scale, divided into a control group and MAT group (who will participate in the MAT). Musculoskeletal function, functional mobility, and balance will be the primary outcomes of interest, assessed with an isokinetic dynamometer, the Five-Times-Sit-to-Stand test (FTSST), the Timed ""Up and Go"" test (TUG), the 6-m gait speed test, the Berg Balance Scale (BBS), and a force platform. Quality of life (QOL), activities of daily living (ADL), and motor aspects will be the secondary outcome measures, assessed with the Parkinson's Disease Questionnaire (PDQ-39) and Unified Parkinson's Disease Rating Scale (UPDRS), sections II and III. The MAT will be 12 weeks long, with two 50-min sessions per week. The outcome measures will be assessed before and after the interventions.
DISCUSSION


This study is expected to establish parameters to prescribe and monitor a MAT program for people with PD in stages 1 to 4 in the Hoehn and Yahr scale, respecting individual progress and assisting the professionals in their procedure with these people.",2022,"The complications from Parkinson's disease (PD) are directly related to decreased muscle function, balance deficits, and independence loss.","[""People with Parkinson's Disease"", 'people with PD between stages 1 and 4 of the Hoehn and Yahr scale', 'people with PD in stages 1 to 4 in the Hoehn and Yahr scale, respecting individual progress and assisting the professionals in their procedure with these people']","['Multicomponent Aquatic Training (MAT) Program', 'Multicomponent Aquatic Training (MAT) protocol', 'Practicing aquatic exercises']","['muscle function, balance deficits, and independence loss', 'Musculoskeletal function, functional mobility, and balance', 'Quality of life (QOL), activities of daily living (ADL), and motor aspects', ""Parkinson's Disease Questionnaire (PDQ-39) and Unified Parkinson's Disease Rating Scale (UPDRS), sections II and III""]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C4274667', 'cui_str': 'Hoehn and Yahr Scale'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0026861', 'cui_str': 'Musculoskeletal function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}]",,0.0414326,"The complications from Parkinson's disease (PD) are directly related to decreased muscle function, balance deficits, and independence loss.","[{'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Siega', 'Affiliation': 'Department of Physical Education, The Federal University of Paraná, Coronel Francisco H. dos Santos, 100, Curitiba 81531-980, Parana, Brazil.'}, {'ForeName': 'Dielise Debona', 'Initials': 'DD', 'LastName': 'Iucksch', 'Affiliation': 'Department of Physical Education, The Federal University of Paraná, Coronel Francisco H. dos Santos, 100, Curitiba 81531-980, Parana, Brazil.'}, {'ForeName': 'Vera Lucia', 'Initials': 'VL', 'LastName': 'Israel', 'Affiliation': 'Department of Physical Education, The Federal University of Paraná, Coronel Francisco H. dos Santos, 100, Curitiba 81531-980, Parana, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph19031727']
2004,35162706,"Football and Zumba Training in Female Hospital Staff: Effects after 12 and 40 Weeks on Self-Reported Health Status, Emotional Wellbeing, General Self-Efficacy and Sleep Problems.","BACKGROUND


This 40-weeks intervention study evaluates the effects on self-reported health status, emotional wellbeing, general self-efficacy and sleep problems among female hospital employees.
METHODS


107 employees were cluster-randomized into three groups; football (FG), Zumba (ZG) and control (CG). Outcome measurements were conducted at baseline, 12 and 40 weeks. Weekly training frequencies in the first 12 and next 28 weeks were 2.4 ± 0.3 and 0.8 ± 0.2 in FG and 2.3 ± 0.3 and 0.9 ± 0.2 in ZG.
RESULTS


Compared to the CG, the ZG showed significant improvement in self-reported health status ( p  = 0.025), a reduced frequency of poor and restless sleep (on a 0-4 scale) ( p  = 0.004), as well as a tendency for reduction in the frequency of problems falling asleep ( p  = 0.055) and overall sleep problems ( p  = 0.051). Between baseline and 12 weeks, both the FG ( p  = 0.017) and the ZG ( p  = 0.017) showed within-group improvements in emotional wellbeing, whereas this improvement was maintained only in the ZG between baseline and 40 weeks ( p  = 0.002). The FG showed a significant within-group improvement in general self-efficacy ( p  = 0.012) between baseline and 12 weeks follow-up, with no such improvements in the other groups.
CONCLUSION


The present findings revealed that a physical activity intervention with Zumba as well as football training may improve mental health and sleep outcomes in female hospital staff.",2022,"Compared to the CG, the ZG showed significant improvement in self-reported health status ( p  = 0.025), a reduced frequency of poor and restless sleep (on a 0-4 scale) ( p  = 0.004), as well as a tendency for reduction in the frequency of problems falling asleep ( p  = 0.055) and overall sleep problems ( p  = 0.051).","['female hospital staff', 'Female Hospital Staff', '107 employees were cluster-randomized into three groups', 'female hospital employees']","['Football and Zumba Training', 'football (FG), Zumba (ZG) and control (CG']","['health status, emotional wellbeing, general self-efficacy and sleep problems', 'self-reported health status', 'frequency of problems falling asleep', 'mental health and sleep outcomes', 'overall sleep problems', 'general self-efficacy', 'reduced frequency of poor and restless sleep', 'Self-Reported Health Status, Emotional Wellbeing, General Self-Efficacy and Sleep Problems', 'emotional wellbeing']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0031228', 'cui_str': 'Hospital Personnel'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0235160', 'cui_str': 'Restless sleep'}]",107.0,0.0488784,"Compared to the CG, the ZG showed significant improvement in self-reported health status ( p  = 0.025), a reduced frequency of poor and restless sleep (on a 0-4 scale) ( p  = 0.004), as well as a tendency for reduction in the frequency of problems falling asleep ( p  = 0.055) and overall sleep problems ( p  = 0.051).","[{'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Barene', 'Affiliation': 'Department of Public Health and Sport Sciences, Inland Norway University of Applied Sciences, 2418 Elverum, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Krustrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, 5230 Odense, Denmark.'}]",International journal of environmental research and public health,['10.3390/ijerph19031685']
2005,35162627,The Effect of 6-Week Combined Balance and Plyometric Training on Dynamic Balance and Quickness Performance of Elite Badminton Players.,"The study aimed to investigate the effect of combined balance and plyometric training on dynamic balance and quickness performance of elite badminton athletes. Sixteen elite male badminton players volunteered to participate and were randomly assigned to a balance-plyometric group (PB: n = 8) and plyometric group (PT: n = 8). The PB group performed balance combined with plyometric training three times a week over 6 weeks (40 min of plyometrics and 20 min of balance training); while the PT group undertook only plyometric training for the same period (3-4 sets × 8-12 reps for each exercise). Both groups were given the same technical training (badminton techniques for 6 days a week). The dynamic stability and quick movement ability were assessed at baseline and after the intervention by measuring the performance of dynamic posture stability test ( DPSI  and COP), T-running test and hexagon jump test. The results showed that compared to PT, PB induced significantly greater improvements in F-DPSI, L-DPSI ( p  = 0.003, 0.025, respectively), F-COP AP , F-COP ML , F-COP PL , L-COP PL  ( p  = 0.024, 0.002, 0.029, 0.043, respectively), T-running test and hexagon jump test ( p  < 0.001). The change in L-DPSI, L-COP AP , L-COP ML  did not differ between PB and PT ( p  > 0.907). The findings suggest that combined training holds great promise of improving the dynamic balance and quickness performance in elite badminton athletes.",2022,"The results showed that compared to PT, PB induced significantly greater improvements in F-DPSI, L-DPSI ( p  = 0.003, 0.025, respectively), F-COP AP , F-COP ML , F-COP PL , L-COP PL  ( p  = 0.024, 0.002, 0.029, 0.043, respectively), T-running test and hexagon jump test ( p  < 0.001).","['Sixteen elite male badminton players volunteered to participate', 'elite badminton athletes', 'Elite Badminton Players']","['6-Week Combined Balance and Plyometric Training', 'balance-plyometric group (PB: n = 8) and plyometric group (PT', 'PT group undertook only plyometric training', 'combined balance and plyometric training']","['dynamic balance and quickness performance', 'change in L-DPSI, L-COP AP , L-COP ML', 'F-DPSI, L-DPSI', 'dynamic stability and quick movement ability', 'F-COP AP , F-COP ML , F-COP PL , L-COP PL', 'Dynamic Balance and Quickness Performance', 'dynamic posture stability test ( DPSI  and COP), T-running test and hexagon jump test']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004678', 'cui_str': 'Badminton'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",16.0,0.0148884,"The results showed that compared to PT, PB induced significantly greater improvements in F-DPSI, L-DPSI ( p  = 0.003, 0.025, respectively), F-COP AP , F-COP ML , F-COP PL , L-COP PL  ( p  = 0.024, 0.002, 0.029, 0.043, respectively), T-running test and hexagon jump test ( p  < 0.001).","[{'ForeName': 'Zepeng', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'China Institute of Sport and Health Science, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Limingfei', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'School of Strength and Conditioning Training, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Wangcheng', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'School of Physical Education, Jiujiang University, Jiujiang 332005, China.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Chuang', 'Affiliation': 'Human Biology Major, University of California San Diego, San Diego, CA 92093, USA.'}, {'ForeName': 'Shixian', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sports Coaching College, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Zhenxiang', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'China Institute of Sport and Health Science, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Dapeng', 'Initials': 'D', 'LastName': 'Bao', 'Affiliation': 'China Institute of Sport and Health Science, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Luyu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Strength and Conditioning Training, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Hebrew SeniorLife Hinda and Arthur Marcus Institute for Aging Research, Harvard Medical School, Boston, MA 02131, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph19031605']
2006,35162622,Marine Survival in the Mediterranean: A Pilot Study on the Cognitive and Cardiorespiratory Response to Sudden Cool Water Immersion.,"BACKGROUND AND AIM


The Mediterranean is one of the major gateways of human migratory fluxes from Northern Africa, the Middle East, and Central Asia to Europe. Sea accidents have become an urgent humanitarian crisis due to the high number of migrants on the move, but data on the physiological effects to sudden cool water immersion are not as extensive as cold-water studies. We wanted to evaluate to what extent cool water immersion (~18 °C) may detrimentally affect cognitive ability and cardiorespiratory strain compared to the more prevalent cold-water (<10-15 °C) studies.
METHODS


In this case, 10 active, healthy men participated in this study which consisted of completing one familiarization trial, and then a control (CON) or experimental (EXP) trial in a randomized, repeated-measures, cross-over fashion, separated by at least 7-days. Cognitive function was assessed via the Symbol Digit Modalities Test (SDMT), a code substitution test, performed at baseline, then repeated in either a thermoneutral (~25 °C room air) dry environment, or when immersed to the neck in 18 °C water. Testing consisted of six ""Step"" time-blocks 45-s each, with a 5-s pause between each Step. Cardiorespiratory measures, continuously recorded, included heart rate (beats per minute), minute ventilation (V˙ E , L∙min -1 ), oxygen consumption (V˙O 2 , L∙min -1 ), and respiratory frequency (fR, count∙min -1 ).
RESULTS


Initial responses to cool water (<2 min) found that participants performed ~11% worse on the code substitution test ( p  = 0.025), consumed 149% greater amounts of oxygen (CI: 5.1 to 9.1 L∙min -1 ,  p  < 0.0001) and experienced higher cardiovascular strain (HR CI: 13 to 38 beats per minute,  p  = 0.001) than during the control trial. Physiological strain was in-line to those observed in much colder water temperature.
CONCLUSION


Sudden, cool water immersion also negatively affects cognitive function and cardiorespiratory strain, especially during the first two minutes of exposure. The magnitude increase in heart rate is strongly associated with poorer cognitive function, even in (relatively) warmer water consistent with temperatures found in the Mediterranean Sea environment.",2022,"RESULTS


Initial responses to cool water (<2 min) found that participants performed ~11% worse on the code substitution test ( p  = 0.025), consumed 149% greater amounts of oxygen (CI: 5.1 to 9.1 L∙min -1 ,  p  < 0.0001) and experienced higher cardiovascular strain (HR CI: 13 to 38 beats per minute,  p  = 0.001) than during the control trial.","['human migratory fluxes from Northern Africa, the Middle East, and Central Asia to Europe', '10 active, healthy men', 'Mediterranean']","['Sudden Cool Water Immersion', 'control (CON) or experimental (EXP']","['heart rate', 'heart rate (beats per minute), minute ventilation (V˙ E , L∙min -1 ), oxygen consumption (V˙O 2 , L∙min -1 ), and respiratory frequency (fR, count∙min -1 ', 'Marine Survival', 'Cognitive function', 'cardiovascular strain']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0232901', 'cui_str': 'Migratory'}, {'cui': 'C0001745', 'cui_str': 'Northern Africa'}, {'cui': 'C0026068', 'cui_str': 'Middle east country'}, {'cui': 'C0003982', 'cui_str': 'Asia, Central'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1276802', 'cui_str': 'Sudden'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]",,0.0675151,"RESULTS


Initial responses to cool water (<2 min) found that participants performed ~11% worse on the code substitution test ( p  = 0.025), consumed 149% greater amounts of oxygen (CI: 5.1 to 9.1 L∙min -1 ,  p  < 0.0001) and experienced higher cardiovascular strain (HR CI: 13 to 38 beats per minute,  p  = 0.001) than during the control trial.","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Buoite Stella', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, University Hospital of Trieste, University of Trieste, 34149 Trieste, Italy.'}, {'ForeName': 'Shawnda A', 'Initials': 'SA', 'LastName': 'Morrison', 'Affiliation': 'Centre for Climate Change and Active Children, Faculty of Sport, University of Ljubljana, 1000 Ljubljana, Slovenia.'}]",International journal of environmental research and public health,['10.3390/ijerph19031601']
2007,35165105,"Process evaluation of peer-to-peer delivery of HIV self-testing and sexual health information to support HIV prevention among youth in rural KwaZulu-Natal, South Africa: qualitative analysis.","OBJECTIVE


Peer-to-peer (PTP) HIV self-testing (HIVST) distribution models can increase uptake of HIV testing and potentially create demand for HIV treatment and pre-exposure prophylaxis (PrEP). We describe the acceptability and experiences of young women and men participating in a cluster randomised trial of PTP HIVST distribution and antiretroviral/PrEP promotion in rural KwaZulu-Natal.
METHODS


Between March and September 2019, 24 pairs of trained peer navigators were randomised to two approaches to distribute HIVST packs (kits+HIV prevention information):  incentivised-peer-networks  where peer-age friends distributed packs within their social network for a small incentive, or  direct distribution  where peer navigators distributed HIVST packs directly. S tandard-of-care  peer navigators distributed information without HIVST kits. For the process evaluation, we conducted semi-structured interviews with purposively sampled young women (n=30) and men (n=15) aged 18-29 years from all arms. Qualitative data were transcribed, translated, coded manually and thematically analysed using an interpretivist approach.
RESULTS


Overall, PTP approaches were acceptable and valued by young people. Participants were comfortable sharing sexual health issues they would not share with adults. Coupled with HIVST, peer (friends) support facilitated HIV testing and solidarity for HIV status disclosure and treatment. However, some young people showed limited interest in other sexual health information provided. Some young people were wary of receiving health information from friends perceived as non-professionals while others avoided sharing personal issues with peer navigators from their community. Referral slips and youth-friendly clinics were facilitators to PrEP uptake. Family disapproval, limited information, daily pills and perceived risks were major barriers to PrEP uptake.
CONCLUSION


Both professional (peer navigators) and social network (friends) approaches were acceptable methods to receive HIVST and sexual health information. Doubts about the professionalism of friends and overly exclusive focus on HIVST information materials may in part explain why HIVST kits, without peer navigators support, did not create demand for PrEP.",2022,Both professional (peer navigators) and social network (friends) approaches were acceptable methods to receive HIVST and sexual health information.,"['semi-structured interviews with purposively sampled young women (n=30) and men (n=15) aged 18-29 years from all arms', 'young women and men participating', 'Between March and September 2019, 24 pairs of trained peer navigators', 'youth in rural KwaZulu-Natal, South Africa']","['PTP HIVST distribution and antiretroviral/PrEP promotion', 'distribute HIVST packs (kits+HIV prevention information):  incentivised-peer-networks  where peer-age friends distributed packs within their social network for a small incentive, or  direct distribution  where peer navigators distributed HIVST packs directly', 'Peer-to-peer (PTP) HIV self-testing (HIVST) distribution models', 'peer-to-peer delivery of HIV self-testing and sexual health information to support HIV prevention']",[],"[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",[],,0.0702149,Both professional (peer navigators) and social network (friends) approaches were acceptable methods to receive HIVST and sexual health information.,"[{'ForeName': 'Oluwafemi Atanda', 'Initials': 'OA', 'LastName': 'Adeagbo', 'Affiliation': 'Department of Health Promotion, Education & Behaviour, University of South Carolina Arnold School of Public Health, Columbia, South Carolina, USA oadeagbo@mailbox.sc.edu.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Social Science & Research Ethics Unit, Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Dumsani', 'Initials': 'D', 'LastName': 'Gumede', 'Affiliation': 'Social Science & Research Ethics Unit, Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Sibongiseni', 'Initials': 'S', 'LastName': 'Xulu', 'Affiliation': 'Social Science & Research Ethics Unit, Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Nondumiso', 'Initials': 'N', 'LastName': 'Dlamini', 'Affiliation': 'Social Science & Research Ethics Unit, Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Manono', 'Initials': 'M', 'LastName': 'Luthuli', 'Affiliation': 'Social Science & Research Ethics Unit, Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Jaco', 'Initials': 'J', 'LastName': 'Dreyer', 'Affiliation': 'Social Science & Research Ethics Unit, Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Herbst', 'Affiliation': 'Social Science & Research Ethics Unit, Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cowan', 'Affiliation': 'International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Natsayi', 'Initials': 'N', 'LastName': 'Chimbindi', 'Affiliation': 'Social Science & Research Ethics Unit, Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hatzold', 'Affiliation': 'Population Services International, Harare, Zimbabwe.'}, {'ForeName': 'Nonhlanhla', 'Initials': 'N', 'LastName': 'Okesola', 'Affiliation': 'Social Science & Research Ethics Unit, Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'Department of HIV/AIDS, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Harling', 'Affiliation': 'Social Science & Research Ethics Unit, Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Hasina', 'Initials': 'H', 'LastName': 'Subedar', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Sherr', 'Affiliation': 'University College London Faculty of Population Health Sciences, London, UK.'}, {'ForeName': 'Nuala', 'Initials': 'N', 'LastName': 'McGrath', 'Affiliation': 'Faculty of Social, Human and Mathematical Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Corbett', 'Affiliation': 'Infectious and Tropical Diseases, LSHTM, London, UK.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shahmanesh', 'Affiliation': 'Social Science & Research Ethics Unit, Africa Health Research Institute, Durban, South Africa.'}]",BMJ open,['10.1136/bmjopen-2021-048780']
2008,35165478,[Efficacy of combined application of glycine powder air-polishing in non-surgical treatment of peri-implant diseases].,"OBJECTIVE


To compare the clinical efficacy of combined application of glycine powder air-polishing and mechanical submucosal debridement in non-surgical treatment of peri-implant diseases.
METHODS


A randomized controlled clinical study was carried out on patients diagnosed with peri-implant diseases in the Department of Periodontology, Peking University School and Hospital of Stomatology, between May of 2020 and June of 2021.Twenty-eight patients with totally sixty-two implants were enrolled.The patients were randomly divided into the test group and control group. The patients in the test group (13 subjects/32 implants) received mechanical submucosal debridement using titanium curettes combined with application of glycine powder air-polishing, while the control group (15 subjects/30 implants) received mechanical submucosal debridement using titanium only. Clinical parameters, such as plaque index (PLI), pocket probing depth (PPD), bleeding index (BI) and the percentage of suppuration on probing on implants' level (SoP%) were measured at baseline and 8 weeks after non-surgical intervention. Changes and group differences of clinical parameters of the implants before and 8 weeks after non-surgical intervention were compared.
RESULTS


Mean PLI, PPD, BI of both the test group and control group significantly reduced 8 weeks after non-surgical intervention ( P  < 0.05). Compared with the control group, the test group achieved lower BI (2.7±0.8  vs . 2.2±0.7,  P  < 0.05), more reduction of BI (0.6±0.7  vs . 1.1±0.6,  P  < 0.01) and more reduction of SoP% (21.9%  vs . 10%,  P  < 0.05) after non-surgical intervention. Both the control and test groups exhibited comparable PLI and PPD reductions ( P >0.05). For the implants diagnosed with peri-implant mucositis, the test group revealed more signi-ficant reduction in BI and SoP% than the control group (1.0±0.7  vs . 0.4±0.7,  P =0.02; 6.3%  vs . 0,  P =0.012). There was no significant difference existing in PLI and PD improvement between the control group and test group ( P >0.05). For the implants diagnosed with peri-implantitis, there was no significant difference existing in PLI, PPD, BI and SoP% improvement values between the test and control groups ( P >0.05). No complications or discomforts were reported during the study.
CONCLUSION


Both treatment procedures could relieve the inflammation of peri-implant soft tissue. Non-surgical mechanical submucosal debridement combined application of glycine powder air-polishing is associated with significant reduction of soft tissue bleeding and suppuration on probing especially in the implants diagnosed with peri-implant mucositis.",2022,"Mean PLI, PPD, BI of both the test group and control group significantly reduced 8 weeks after non-surgical intervention ( P  < 0.05).","['peri-implant diseases', 'patients diagnosed with peri-implant diseases in the Department of Periodontology, Peking University School and Hospital of Stomatology, between May of 2020 and June of 2021.Twenty-eight patients with totally sixty-two implants were enrolled']","['mechanical submucosal debridement using titanium only', 'glycine powder air-polishing and mechanical submucosal debridement', 'mechanical submucosal debridement using titanium curettes combined with application of glycine powder air-polishing', 'glycine powder air-polishing']","['Mean PLI, PPD, BI', 'PLI and PD improvement', 'reduction of BI', 'signi-ficant reduction', ""plaque index (PLI), pocket probing depth (PPD), bleeding index (BI) and the percentage of suppuration on probing on implants' level (SoP"", 'PLI and PPD reductions', 'lower BI', 'PLI, PPD, BI and SoP% improvement values', 'reduction of SoP']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0031098', 'cui_str': 'Periodontics'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029167', 'cui_str': 'Medicine, Oral'}, {'cui': 'C4517835', 'cui_str': '62'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0180236', 'cui_str': 'Curette'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0038862', 'cui_str': 'Suppurative inflammation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",62.0,0.0402511,"Mean PLI, PPD, BI of both the test group and control group significantly reduced 8 weeks after non-surgical intervention ( P  < 0.05).","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry, Beijing 100081, China.'}, {'ForeName': 'S Q', 'Initials': 'SQ', 'LastName': 'Li', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry, Beijing 100081, China.'}, {'ForeName': 'Y P', 'Initials': 'YP', 'LastName': 'Wei', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry, Beijing 100081, China.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Zhong', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry, Beijing 100081, China.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry, Beijing 100081, China.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Hu', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry, Beijing 100081, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
2009,35166384,Gut-brain axis dysfunction underlies FODMAP-induced symptom generation in irritable bowel syndrome.,"BACKGROUND


FODMAPs produce similar small bowel water and colonic gas in patients with irritable bowel syndrome (IBS) and healthy controls (HCs), despite IBS patients reporting increased gastrointestinal (GI) symptoms.
AIM


To unravel the mechanisms underlying FODMAP-induced symptom reporting, we investigated gut and brain responses to fructan administration in IBS patients and HC.
METHODS


This randomised, double-blind, cross-over study consisted of three visits where fructans (40 g/500 mL saline), glucose (40 g/500 mL saline) or saline (500 mL) were infused intragastrically during 1 h MR brain scanning; abdominal MRI was performed before, 1 h, and 2 h post-infusion. Symptoms were rated using validated scales.
RESULTS


In IBS (n = 13), fructans induced more cramps, pain, flatulence and nausea compared to glucose (P = 0.03, 0.001, 0.009 and <0.001 respectively), contrary to HC (n = 13) (all P > 0.14), with between-group differences for cramps and nausea (P = 0.004 and 0.023). Fructans increased small bowel motility and ascending colonic gas and volume equally in IBS and HC (between-group P > 0.25). The difference in colonic gas between fructans and saline covaried with differences in bloating and cramps in IBS (P = 0.008 and 0.035 respectively). Pain-related brain regions responded differentially to fructans in IBS compared to HC, including the cerebellum, supramarginal gyrus, anterior and midcingulate cortex, insula and thalamus (p FWE-corrected   < 0.05); these brain responses covaried with symptom responses in IBS.
CONCLUSIONS


Fructans increase small bowel motility and colon gas and volume similarly in IBS patients and HC. Increased symptom responses to fructans in IBS covary with altered brain responses in pain-related regions, indicating that gut-brain axis dysregulation may drive FODMAP-induced symptom generation in IBS.",2022,Fructans increased small bowel motility and ascending colonic gas and volume equally in IBS and HC (between-group P > 0.25).,"['patients with irritable bowel syndrome (IBS) and healthy controls (HCs), despite IBS patients reporting increased gastrointestinal (GI) symptoms', 'irritable bowel syndrome']","['fructans (40\xa0g/500\xa0mL saline), glucose (40\xa0g/500\xa0mL saline) or saline']","['small bowel motility and colon gas', 'small bowel motility and ascending colonic gas and volume equally in IBS and HC', 'cramps, pain, flatulence and nausea', 'bloating and cramps in IBS', 'cramps and nausea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]","[{'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C0232618', 'cui_str': 'Small bowel motility'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.115346,Fructans increased small bowel motility and ascending colonic gas and volume equally in IBS and HC (between-group P > 0.25).,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Imke', 'Initials': 'I', 'LastName': 'Masuy', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Biesiekierski', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Fitzke', 'Affiliation': 'The Wingate Institute for Neurogastroenterology, Queen Mary University London, London, UK.'}, {'ForeName': 'Chinar', 'Initials': 'C', 'LastName': 'Parikh', 'Affiliation': 'Medical School, University College London, London, UK.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Schofield', 'Affiliation': 'Medical School, University College London, London, UK.'}, {'ForeName': 'Hafsa', 'Initials': 'H', 'LastName': 'Shaikh', 'Affiliation': 'Medical School, University College London, London, UK.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Bhagwanani', 'Affiliation': 'University College London Hospital, London, UK.'}, {'ForeName': 'Qasim', 'Initials': 'Q', 'LastName': 'Aziz', 'Affiliation': 'The Wingate Institute for Neurogastroenterology, Queen Mary University London, London, UK.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Taylor', 'Affiliation': 'Centre for Medical Imaging, University College London, London, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tack', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Van Oudenhove', 'Affiliation': 'Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16812']
2010,35141977,Evaluation of contraction of the split-thickness skin graft using three dermal matrices in the treatment of burn contractures: A randomised clinical trial.,"Burn injuries commonly result in serious sequelae (such as skin contractures) in surviving patients, for which no single optimal solution is known. The goal of this study was to compare the late contraction of autologous skin grafts with or without dermal matrices used in the treatment of patients with burn contractures. This parallel design prospective, randomised and controlled clinical trial included patients with burn contracture treated using autologous skin grafts and dermal matrix. Patients were randomly assigned to one of the four groups: Integra® matrix (n = 10), Pelnac® matrix (n = 10), Matriderm® matrix (n = 9) or a Control Group (n = 10, without dermal matrix, only skin graft). The boundaries of skin defect were marked and transferred to a flat sterile surface for area measurement. The current area of the skin grafts was measured during surgery and compared with those obtained at 1, 3, 6 and 12 months postoperatively. Twelve months after surgery, the Control Group presented lower rates of skin graft contraction than Integra® (p < 0.01), Matriderm® (p = 0.01) and Pelnac® (p < 0.01) groups. Pelnac® resulted in larger skin graft contraction than Matriderm® (p < 0.01) and Integra® (p = 0.02), while differences between Integra® and Matriderm® were not significant (p = 0.16). The comparison between intraoperative and 12 months after surgery showed that the worst mean rates of skin graft contraction were from the Pelnac® (51.79%) and Matriderm® (59.17%). In patients with burn contractures, the use of these three dermal matrices did not reduce or avoid the occurrence of late contraction of the skin graft, so their use for this purpose should be carefully evaluated.",2022,"Pelnac® resulted in larger skin graft contraction than Matriderm® (p<0.01) and Integra® (p=0.02), while differences between Integra® and Matriderm® were not significant (p=0.16).","['patients with burn contractures', 'surviving patients', 'patients with burn contracture treated using', 'burn contractures']","['autologous skin grafts and dermal matrix', 'split-thickness skin graft', 'autologous skin grafts with or without dermal matrices', 'Pelnac® matrix (n=10), Matriderm® matrix (n=9), or a Control Group (n=10, without dermal matrix, only skin graft', 'Integra® matrix']","['rates of skin graft contraction', 'larger skin graft contraction', 'skin graft contraction', 'current area of the skin grafts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0037297', 'cui_str': 'Grafting to skin'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0439061', 'cui_str': 'Split thickness skin graft (procedure)'}, {'cui': 'C2606444', 'cui_str': 'matriderm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037297', 'cui_str': 'Grafting to skin'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.0377477,"Pelnac® resulted in larger skin graft contraction than Matriderm® (p<0.01) and Integra® (p=0.02), while differences between Integra® and Matriderm® were not significant (p=0.16).","[{'ForeName': 'Fernanda B', 'Initials': 'FB', 'LastName': 'Corrêa', 'Affiliation': 'Division of Plastic Surgery, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Júlio C D', 'Initials': 'JCD', 'LastName': 'Castro', 'Affiliation': 'Division of Plastic Surgery, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Ivan R', 'Initials': 'IR', 'LastName': 'Almeida', 'Affiliation': 'Division of Plastic Surgery, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Jayme A', 'Initials': 'JA', 'LastName': 'Farina-Junior', 'Affiliation': 'Division of Plastic Surgery, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Pedro S', 'Initials': 'PS', 'LastName': 'Coltro', 'Affiliation': 'Division of Plastic Surgery, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.13002']
2011,35143095,Effect of baseline infarct size on endovascular thrombectomy with or without intravenous alteplase in stroke patients: A subgroup analysis of a randomized trial (DIRECT-MT).,"BACKGROUND AND PURPOSE


DIRECT-MT showed that endovascular thrombectomy was noninferior to thrombectomy preceded by intravenous alteplase with regard to functional outcome in patients with acute ischemic stroke. In this post hoc analysis, we examined whether infarct size modified the effect of alteplase.
METHODS


All patients with baseline Alberta Stroke Program Early Computed Tomography Score (ASPECTS) grades were included. The primary outcome was the 90-day modified Rankin Scale (mRS) score. Multivariate ordinal logistic regression analysis was used to calculate the adjusted common odds ratio (OR) for better functional outcome based on the mRS for thrombectomy alone versus combination therapy. An interaction term was entered to test for an interaction with baseline ASPECTS subgroups: 0-4 versus 5-7 versus 8-10.
RESULTS


Of 649 patients, 323 (49.8%) were in the thrombectomy-alone group and 326 (50.2%) in the combination-therapy group. There was no significant treatment-by-trichotomized ASPECTS interaction with alteplase prior to endovascular treatment for the primary endpoint of ordinal mRS (p-value interaction term relative to ASPECTS 8-10: ASPECTS 0-4, p = 0.386; ASPECTS 5-7, p = 0.936). Adjusted common ORs for improvement in the 90-day mRS with thrombectomy alone compared with combination therapy were 1.99 (95% confidence interval = 0.72-5.46) for ASPECTS 0-4, 1.07 (0.62-1.86) for ASPECTS 5-7, and 1.03 (0.74-1.45) for ASPECTS 8-10. There was no significant difference in the safety outcomes between the two groups.
CONCLUSIONS


Baseline infarct size may not modify the effect of alteplase prior to endovascular thrombectomy with regard to favorable functional outcomes and adverse events.",2022,Adjusted common OR for improvement in the 90-day mRS with thrombectomy alone compared with combination therapy were 1.99,"['stroke patients', 'patients with acute ischemic stroke', 'Of 649 patients, 323 (49.8%) were in the thrombectomy-alone group and 326 (50.2%) in the combination-therapy group', 'All patients with baseline Alberta Stroke Program Early Computed Tomography Score (ASPECTS) grade were included']",['endovascular thrombectomy with or without intravenous alteplase'],"['90-day modified Rankin Scale (mRS) score', 'safety outcomes']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",649.0,0.32829,Adjusted common OR for improvement in the 90-day mRS with thrombectomy alone compared with combination therapy were 1.99,"[{'ForeName': 'Zhen Yu', 'Initials': 'ZY', 'LastName': 'Jia', 'Affiliation': 'Department of Radiology, First Affiliated Hospital With Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yong Xin', 'Initials': 'YX', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, Naval Medical University Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Yue Zhou', 'Initials': 'YZ', 'LastName': 'Cao', 'Affiliation': 'Department of Radiology, First Affiliated Hospital With Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lin Bo', 'Initials': 'LB', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiology, First Affiliated Hospital With Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Hai Bin', 'Initials': 'HB', 'LastName': 'Shi', 'Affiliation': 'Department of Radiology, First Affiliated Hospital With Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, Naval Medical University Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Zi Fu', 'Initials': 'ZF', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Naval Medical University Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Hong Jian', 'Initials': 'HJ', 'LastName': 'Shen', 'Affiliation': 'Department of Neurosurgery, Naval Medical University Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Lou', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yong Wei', 'Initials': 'YW', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Naval Medical University Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Guo Cong', 'Initials': 'GC', 'LastName': 'Yin', 'Affiliation': ""Department of Neurology, Hangzhou First People's Hospital of Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Xiao Fei', 'Initials': 'XF', 'LastName': 'Ye', 'Affiliation': 'Department of Statistics, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Peng Fei', 'Initials': 'PF', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, Naval Medical University Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, First Affiliated Hospital With Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jian Min', 'Initials': 'JM', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Naval Medical University Changhai Hospital, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of neurology,['10.1111/ene.15276']
2012,34876336,"Effects of Dual Transcranial Direct Current Stimulation and Modified Constraint Induced Movement Therapy to Improve Upper-Limb Function After Stroke: A Double-Blinded, Pilot Randomized Controlled Trial.",,2022,,[],['Dual Transcranial Direct Current Stimulation and Modified Constraint Induced Movement Therapy'],['Upper-Limb Function'],[],"[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.258854,,"[{'ForeName': 'Rittu', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Neurological Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-133207, Haryana, India. Electronic address: ritubhardwaj3105@gmail.com.'}, {'ForeName': 'Vencita Priyanka', 'Initials': 'VP', 'LastName': 'Aranha', 'Affiliation': 'Department of Pediatric and Neonatal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-133207, Haryana, India. Electronic address: vencita.peds@mmumullana.org.'}, {'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': 'Department of Neurological Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-133207, Haryana, India. Electronic address: akankshasaxena623@gmail.com.'}, {'ForeName': 'Asir John', 'Initials': 'AJ', 'LastName': 'Samuel', 'Affiliation': 'Department of Pediatric and Neonatal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-133207, Haryana, India. Electronic address: asirjohnsamuel@mmumullana.org.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2021.106227']
2013,35143714,Different scaling and root planing strategies in Turkish patients with aggressive periodontitis: A randomized controlled clinical trial.,"OBJECTIVES


The aim of this study was to compare clinical, cytokine and microbiological responses after quadrant-based scaling and root planing (Q-SRP), full-mouth SRP (FM-SRP) and full-mouth disinfection (FMD) in patients with generalized aggressive periodontitis (GAgP), which is currently termed as generalized stage-III and grade-C periodontitis.
METHODS


Forty-two patients with GAgP were randomly assigned into groups as Q-SRP, FM-SRP or FMD with chlorhexidine. Clinical parameters were recorded, and gingival crevicular fluid (GCF) and subgingival plaque samples were collected at baseline, 3 and 6 months after treatment. GCF levels of interleukin (IL)-1β and IL-17 were analysed using ELISA. Quantities of six bacterial species were determined using qPCR.
RESULTS


Clinical parameters improved significantly in all groups at 3 and 6 months (p < 0.05). Percentage of sites with probing depth >6 mm was lower in the FMD than Q-SRP group at 3 and 6 months (p < 0.05). FMD showed significantly higher percentage of pocket closure compared with Q-SRP and FM-SRP at both 3 and 6 months after treatment (p < 0.05). The IL-1β levels decreased only in the FMD group (p < 0.05), whereas no changes were found in IL-17 levels in any group. The levels of five out of six bacterial species decreased at 3 and/or 6 months only in the FMD group (p < 0.05).
CONCLUSIONS


The FMD treatment appears to offer superior outcome than Q-SRP and could be the first choice for patients with GAgP.",2022,"The levels of five out of six bacterial species decreased at 3 and/or 6 months only in the FMD group (p<0.05).
","['Forty-two patients with GAgP', 'Turkish Patients With Aggressive Periodontitis', 'patients with GAgP', 'patients with generalized aggressive periodontitis (GAgP']","['Different Scaling And Root Planing Strategies', 'Q-SRP, FM-SRP or FMD with chlorhexidine', 'quadrant-based scaling and root planing (Q-SRP), full-mouth SRP (FM-SRP) and full-mouth disinfection (FMD']","['gingival crevicular fluid (GCF) and subgingival plaque samples', 'IL-17 levels', 'levels of five out of six bacterial species', 'GCF levels of interleukin (IL)-1β and IL-17', 'IL-1β levels']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0001342', 'cui_str': 'Acute periodontitis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0074512', 'cui_str': 'SRP (Signal Recognition Particle)'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0399451', 'cui_str': 'Subgingival plaque'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}]",42.0,0.0688091,"The levels of five out of six bacterial species decreased at 3 and/or 6 months only in the FMD group (p<0.05).
","[{'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Mamaklıoğlu', 'Affiliation': 'Department of Periodontology, Institute of Health Sciences, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Maribasappa', 'Initials': 'M', 'LastName': 'Karched', 'Affiliation': 'Oral Microbiology Research Laboratory, Faculty of Dentistry, Kuwait University, Safat, Kuwait.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Kuru', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Kuru', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Yeditepe University, Istanbul, Turkey.'}, {'ForeName': 'Sirkka', 'Initials': 'S', 'LastName': 'Asikainen', 'Affiliation': 'Oral Microbiology Research Laboratory, Faculty of Dentistry, Kuwait University, Safat, Kuwait.'}, {'ForeName': 'Başak', 'Initials': 'B', 'LastName': 'Doğan', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}]",International journal of dental hygiene,['10.1111/idh.12592']
2014,35144179,Effects of shell angle on clinical and radiological outcomes after single-level cervical disc arthroplasty with Prestige LP prosthesis.,"BACKGROUND


Cervical disc arthroplasty (CDA) using Prestige LP disc has been widely used for cervical degenerative disease. Postoperative shell angle (SA) is the angle between the upper and lower prosthesis endplate and previous studies have reported a significant correlation between prosthesis SA with postoperative biomechanical stress. Due to the lack of reference range in SA, a larger discrepancy exists in postoperative SA among the patients after CDA with Prestige LP disc.
METHODS


A total of 160 patients who had been subjected to single level CDA with Prestige-LP were enrolled. SA was defined the angle between the upper and lower prosthesis endplate and patients were assigned into parallel (SA 0°-3°) and lordotic (SA > 3°) groups according to the immediate postoperative SA. Patients were followed up for a mean duration of 27.78 ± 5.13 months. Clinical, radiographic and complication data were compared among groups.
RESULTS


90 patients were assigned in the parallel group while 70 patients were included in the lordotic group. The mean immediate postoperative SA in the parallel and lordotic groups were 1.64 ± 0.08° and 4.88 ± 1.20°, respectively (p < 0.05). FSU angle in the parallel group at 1 year and last follow-up were 2.6 ± 2.1° and 2.1 ± 2.0°, respectively, with a change value of - 0.68 ± 2.28°. In the lordotic group, FSU angle at 1 year and last follow-up were 3.3 ± 2.5° and 3.1 ± 2.2°, respectively, with a change value of 0.70 ± 1.43°. At 1 year, the FSU angle in the parallel group was significantly low than in the lordotic group (p < 0.05). Besides, average intervertebral space heights (ISH) at 6 months, 1 year and last follow-up were 6.81 ± 0.38 mm, 6.79 ± 0.3 7 mm, 6.78 ± 0.36 mm in the parallel group and 6.64 ± 0.24 mm, 6.32 ± 0.19 mm, 6.30 ± 0.19 mm in the lordotic group, respectively (all p < 0.05). There were no significant differences in clinical outcomes and complications between the groups (p > 0.05).
CONCLUSIONS


Immediate postoperative SA has no significant effects on clinical outcomes and complications after CDA with Prestige-LP. However, it has a positive correlation with postoperative FSU angle and a negative correlation with ISH maintenance.",2022,"There were no significant differences in clinical outcomes and complications between the groups (p > 0.05).
","['90 patients were assigned in the parallel group while 70 patients were included in the lordotic group', '160 patients who had been subjected to single level CDA with Prestige-LP were enrolled', 'single-level cervical disc arthroplasty with Prestige LP prosthesis', '6.78\xa0±\xa00.36\xa0mm in the parallel group and 6.64\xa0±\xa00.24\xa0mm, 6.32\xa0±\xa00.19\xa0mm, 6.30\xa0±\xa00.19\xa0mm in the lordotic group, respectively ']",['Cervical disc arthroplasty (CDA) using Prestige LP disc'],"['average intervertebral space heights (ISH', 'mean immediate postoperative SA', 'clinical outcomes and complications', 'Postoperative shell angle (SA', 'clinical and radiological outcomes', 'FSU angle']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C4517452', 'cui_str': '0.36'}, {'cui': 'C4517441', 'cui_str': '0.24'}, {'cui': 'C4517435', 'cui_str': '0.19'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C0223088', 'cui_str': 'Structure of intervertebral space'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",160.0,0.0984719,"There were no significant differences in clinical outcomes and complications between the groups (p > 0.05).
","[{'ForeName': 'Haimiti', 'Initials': 'H', 'LastName': 'Abudouaini', 'Affiliation': 'Department of Orthopedic Surgery, Third Military Medical University Southwest Hospital, Chongqing, China. Electronic address: hmtspine@163.com.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedic Surgery, West China Hospital, Sichuan University, China. Electronic address: liuhaospine@163.com.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Emergency Department of West China Hospital, Sichuan University/ West China school of Nursing, Sichuan University. Electronic address: 511134378@qq.com.'}, {'ForeName': 'Beiyu', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedic Surgery, West China Hospital, Sichuan University, China. Electronic address: wangbyspine@163.com.'}, {'ForeName': 'Tingkui', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedic Surgery, West China Hospital, Sichuan University, China. Electronic address: wtkspine@163.com.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedic Surgery, West China Hospital, Sichuan University, China. Electronic address: mengyangspine@163.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2022.107164']
2015,35144203,The effects of an ethics laboratory program on moral sensitivity and professional values in nursing students: A randomized controlled study.,"BACKGROUND


Recently, moral sensitivity and professional values have become increasingly important in nursing education and have been tried to be improved.
OBJECTIVES


To investigate the effects of an ethics laboratory program integrated with the fundamentals of nursing course on the moral sensitivity and professional values of nursing students.
DESIGN


The present study was designed as a randomized controlled study. The 8-week ethics laboratory program was applied to the students in the intervention group. In the ethics laboratory program, interactive education methods, such as ethical scenarios, case studies, roleplay, group discussions, project papers and watching movies, were applied. Control group received the standard fundamentals of nursing curriculum.
PARTICIPANTS


The sample size was determined using stratified block randomization method, and 100 nursing students were assigned to intervention (n = 50) and control group (n = 50).
RESULTS


There was no baseline difference between the groups. The moral sensitivity average of the students in the intervention (82.66 ± 12.57) was lower than the average of the control group (85.64 ± 16.83) after the ethics laboratory program; however, the difference was not statistically significant (p > .05). Similarly, there were no significant differences between the intervention (132.32 ± 16.83) and the control group (131.81 ± 20.55) regarding the average score of professional values. In the responsibility sub-dimension of professional values, there was a statistically significant increase in the intervention group (p < .05).
CONCLUSION


The findings suggest that the ethics laboratory program for nursing students is effective in promoting responsibility sub-dimension of professional values. However, there was no significant effect on students' moral sensitivity and other dimensions of professional values. Further refinements of interventional research in ethics education and measurement of learning outcomes should be developed.",2022,"Similarly, there were no significant differences between the intervention (132.32 ± 16.83) and the control group (131.81 ± 20.55) regarding the average score of professional values.","['nursing students', 'The sample size was determined using stratified block randomization method, and 100 nursing students']","['ethics laboratory program', 'standard fundamentals of nursing curriculum']","[""students' moral sensitivity and other dimensions of professional values"", 'average score of professional values', 'moral sensitivity and professional values']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0430482,"Similarly, there were no significant differences between the intervention (132.32 ± 16.83) and the control group (131.81 ± 20.55) regarding the average score of professional values.","[{'ForeName': 'Büşra', 'Initials': 'B', 'LastName': 'Ertuğrul', 'Affiliation': 'Dokuz Eylul University, Institute of Health Sciences, Nursing Faculty, Izmir, Turkey. Electronic address: busra_diker@hotmail.com.'}, {'ForeName': 'Gülşah Gürol', 'Initials': 'GG', 'LastName': 'Arslan', 'Affiliation': 'Dokuz Eylul University, Nursing Faculty, Izmir, Turkey.'}, {'ForeName': 'Cahide', 'Initials': 'C', 'LastName': 'Ayik', 'Affiliation': 'Dokuz Eylul University, Institute of Health Sciences, Nursing Faculty, Izmir, Turkey.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Özden', 'Affiliation': 'Dokuz Eylul University, Nursing Faculty, Izmir, Turkey.'}]",Nurse education today,['10.1016/j.nedt.2022.105290']
2016,35144947,A pilot randomised controlled trial of an energy management programme for adults on maintenance haemodialysis: the fatigue-HD study.,"BACKGROUND


Identifying interventions to reduce fatigue and improve life participation are top research priorities of people on maintenance haemodialysis.
OBJECTIVE


Our primary objective was to explore the feasibility of conducting a randomised controlled trial of an energy management programme for people on maintenance haemodialysis.
DESIGN


Parallel-arm, 1:1, blinded, pilot randomised controlled trial.
PARTICIPANTS


Participants were recruited from 6 dialysis units in Calgary, Canada. Eligible patients were on maintenance haemodialysis, clinically stable and reported disabling fatigue on the Fatigue Severity Scale items 5, 7, 8 and 9.
RANDOMISATION


Participants were randomised using a computer-generated random number sequence according to permuted blocked randomisation, stratified by dialysis unit.
BLINDING


Participants were blinded to treatment allocation.
INTERVENTIONS


Participants received an attention control (general disease self-management education) or the Personal Energy Planning (PEP) programme, a tailored, web-supported 7-9 weeks energy management programme.
OUTCOMES


Eligibility, recruitment and attrition rates were recorded, and standardised intervention effects (Hedge's G) were calculated for fatigue and life participation questionnaires at one1-week postintervention and 12-week postintervention.
RESULTS


159 of 253 screened patients were eligible to be approached. 42 (26%) had fatigue, were interested and consented to participate, of whom 30 met eligibility criteria and were randomised (mean age 62.4 years (±14.7), 60% male). 22 enrolled participants (73%) completed all study procedures. Medium-sized intervention effects were observed on the Canadian Occupational Performance Measure (COPM)-Performance Scale, Global Life Participation Scale and Global Life Participation Satisfaction Scale at 1-week postintervention follow-up, compared with control. At 12-week follow-up, large and very large intervention effects were observed on the COPM-Performance Scale and COPM-Satisfaction Scale, respectively.
CONCLUSION


It is feasible to enrol and follow patients on haemodialysis in a randomised controlled trial of an energy management intervention. As the intervention was associated with improved life participation on some measures, a larger trial is justified.",2022,"At 12-week follow-up, large and very large intervention effects were observed on the COPM-Performance Scale and COPM-Satisfaction Scale, respectively.
","['42 (26%) had fatigue, were interested and consented to participate, of whom 30 met eligibility criteria and were randomised (mean age 62.4 years (±14.7), 60% male', 'Participants were recruited from 6 dialysis units in Calgary, Canada', 'Eligible patients were on maintenance haemodialysis, clinically stable and reported disabling fatigue on the Fatigue Severity Scale items 5, 7, 8 and 9', '22 enrolled participants (73%) completed all study procedures', 'people on maintenance haemodialysis', '159 of 253 screened patients were eligible to be approached', 'adults on maintenance haemodialysis']","['Participants received an attention control (general disease self-management education) or the Personal Energy Planning (PEP) programme, a tailored, web-supported 7-9\u2009weeks energy management programme', 'energy management programme']","['COPM-Performance Scale and COPM-Satisfaction Scale', 'Eligibility, recruitment and attrition rates', 'fatigue and life participation questionnaires', 'Canadian Occupational Performance Measure (COPM)-Performance Scale, Global Life Participation Scale and Global Life Participation Satisfaction Scale']","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1629858', 'cui_str': 'Dialysis unit'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1621943', 'cui_str': 'Energy conservation'}]","[{'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",22.0,0.119332,"At 12-week follow-up, large and very large intervention effects were observed on the COPM-Performance Scale and COPM-Satisfaction Scale, respectively.
","[{'ForeName': 'Janine F', 'Initials': 'JF', 'LastName': 'Farragher', 'Affiliation': 'Department of Occupational Science & Occupational Therapy, University of Toronto, Toronto, Ontario, Canada janine.farragher@utoronto.ca.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Ravani', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Braden', 'Initials': 'B', 'LastName': 'Manns', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Elliott', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Chandra', 'Initials': 'C', 'LastName': 'Thomas', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Maoliosa', 'Initials': 'M', 'LastName': 'Donald', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Verdin', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Brenda R', 'Initials': 'BR', 'LastName': 'Hemmelgarn', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, Alberta, Canada.'}]",BMJ open,['10.1136/bmjopen-2021-051475']
2017,35144945,"Efficacy of prothrombin complex concentrate (PCC) versus fresh frozen plasma (FFP) in reducing perioperative blood loss in cardiac surgery: study protocol for a non-inferiority, randomised controlled trial.","OBJECTIVE


To explore whether prothrombin complex concentrate (PCC) is not inferior to fresh frozen plasma (FFP) with regard to reducing perioperative blood loss in patients undergoing cardiac surgery under cardiopulmonary bypass (CPB).
SETTING


Fu Wai Hospital, and Peking Union Medical College Hospital in China.
PARTICIPANTS


Patients undergoing elective coronary artery bypass grafting, valve replacement or valvuloplasty under CPB, between 18 and 80 years old, will be included.
DESIGN


This study is a non-inferiority, randomised controlled clinical trial. A total of 594 subjects will be randomly assigned to two groups (group PCC and group FFP) and given corresponding interventions when at least one of the following criteria is met: (1) international normalised ratio >1.7 measured 20 min after CPB, (2) prolonged prothrombin time or activated partial thromboplastin time (>1.5 times baseline) measured 20 min after CPB and (3) excessive bleeding observed. 4-factor PCC (15 IU/kg) and FFP (10 mL/kg) will be given to group PCC and group FFP, respectively. Preoperative management, anaesthetic and surgical techniques will be standardised for both groups.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcome is the volume of blood loss during and within 24 hours after surgery. The secondary outcomes include (1) the total units of allogeneic red blood cells transfused during and within 7 days after surgery, (2) re-exploration due to postoperative bleeding within 7 days after surgery, (3) adverse events and serious adverse events within 30 days after surgery and (4) length of intensive care unit stay and hospital stay.
TRIAL REGISTRATION NUMBER


Registered under NCT04244981 at ClinicalTrials.gov on 28 January 2020, https://clinicaltrials.gov/ct2/show/NCT04244981?cond=NCT04244981&draw=2&rank=1.
ETHICS AND DISSEMINATION


This study has been approved by the Institutional Review Board of Peking Union Medical College Hospital (ZS-2242).",2022,"A total of 594 subjects will be randomly assigned to two groups (group PCC and group FFP) and given corresponding interventions when at least one of the following criteria is met: (1) international normalised ratio >1.7 measured 20 min after CPB, (2) prolonged prothrombin time or activated partial thromboplastin time (>1.5 times baseline) measured 20 min after CPB and (3) excessive bleeding observed.","['Patients undergoing elective coronary artery bypass grafting, valve replacement or valvuloplasty under CPB, between 18 and 80 years old, will be included', 'cardiac surgery', 'patients undergoing cardiac surgery under cardiopulmonary bypass (CPB', 'Fu Wai Hospital, and Peking Union Medical College Hospital in China', '594 subjects']","['4-factor PCC', 'prothrombin complex concentrate (PCC) versus fresh frozen plasma (FFP', 'prothrombin complex concentrate (PCC', 'FFP', 'PCC and group FFP']","['total units of allogeneic red blood cells transfused during and within 7\u2009days after surgery, (2) re-exploration due to postoperative bleeding within 7\u2009days after surgery, (3) adverse events and serious adverse events within 30 days after surgery and (4) length of intensive care unit stay and hospital stay', 'perioperative blood loss', 'prothrombin time or activated partial thromboplastin time', 'volume of blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C4048712', 'cui_str': 'factor IX complex'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1293095', 'cui_str': 'Reexploration procedure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",594.0,0.22516,"A total of 594 subjects will be randomly assigned to two groups (group PCC and group FFP) and given corresponding interventions when at least one of the following criteria is met: (1) international normalised ratio >1.7 measured 20 min after CPB, (2) prolonged prothrombin time or activated partial thromboplastin time (>1.5 times baseline) measured 20 min after CPB and (3) excessive bleeding observed.","[{'ForeName': 'Lijian', 'Initials': 'L', 'LastName': 'Pei', 'Affiliation': 'Department of Anaesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Department of Anaesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuelun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Medical Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Anaesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China shijia@fuwai.com.'}]",BMJ open,['10.1136/bmjopen-2021-051072']
2018,35144944,Nurse-led home-visitation programme for first-time mothers in reducing maltreatment and improving child health and development (BB:2-6): longer-term outcomes from a randomised cohort using data linkage.,"OBJECTIVES


Measure effectiveness of family nurse partnership (FNP) home-visiting programme in reducing maltreatment and improving maternal health and child health, developmental and educational outcomes; explore effect moderators, mediators; describe costs.
DESIGN


Follow-up of BB:0-2 trial cohort (ISRCTN:23019866) up to age 7 years in England using record linkage.
PARTICIPANTS


1618 mothers aged 19 years or younger and their firstborn child(ren) recruited to BB:0-2 trial at less than 25 weeks gestation and not mandatorily withdrawn from trial or opted out. Intervention families were offered up to a maximum of 64 home visits by specially trained nurses from pregnancy until firstborn child was 2 years old, plus usually provided health and social care support. Comparator was usual care alone.
OUTCOME MEASURES


Primary outcome: state-verified child-in-need status recorded at any time during follow-up.
SECONDARY OUTCOMES


referral to social services, child protection registration (plan), child-in-need categorisation, looked-after status, recorded injuries and ingestions any time during follow-up, early childcare and educational attendance, school readiness and attainment at key stage 1 (KS1), healthcare costs.
RESULTS


Match rates for 1547 eligible children (1517 singletons, 15 sets of twins) were 98.3% (NHS Digital) and 97.4% (National Pupil Database). There was no difference between study arms in the proportion of children being registered as in need (adjusted OR 0.98, 95% CI 0.74 to 1.31), or for any other measure of maltreatment. Children in the FNP arm were more likely to achieve a good level of development at reception age (school readiness) (adjusted OR 1.24, 95% CI 1.01 to 1.52). After adjusting for birth month, children in FNP arm were more likely to reach the expected standard in reading at KS1 (adjusted OR 1.26, 95% CI 1.02 to 1.57). We found no trial arm differences for resource use and costs.
CONCLUSIONS


FNP did not improve maltreatment or maternal outcomes. There was evidence of small advantages in school readiness and attainment at KS1.
TRIAL REGISTRATION NUMBER


ISRCTN23019866.",2022,"Children in the FNP arm were more likely to achieve a good level of development at reception age (school readiness) (adjusted OR 1.24, 95% CI 1.01 to 1.52).","['1547 eligible children (1517 singletons, 15 sets of twins', '1618 mothers aged 19 years or younger and their firstborn child(ren) recruited to BB:0-2 trial at less than 25 weeks gestation and not mandatorily withdrawn from trial or opted out']","['family nurse partnership (FNP) home-visiting programme', '64 home visits by specially trained nurses from pregnancy until firstborn child was 2 years old, plus usually provided health and social care support', 'Nurse-led home-visitation programme']","['resource use and costs', 'state-verified child-in-need status recorded at any time during follow-up', 'referral to social services, child protection registration (plan), child-in-need categorisation, looked-after status, recorded injuries and ingestions any time during follow-up, early childcare and educational attendance, school readiness and attainment at key stage 1 (KS1), healthcare costs', 'good level of development at reception age (school readiness', 'maltreatment or maternal outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0439787', 'cui_str': 'Out'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1277300', 'cui_str': 'Child in need'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0150776', 'cui_str': 'Referral to Social Services'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1618.0,0.16157,"Children in the FNP arm were more likely to achieve a good level of development at reception age (school readiness) (adjusted OR 1.24, 95% CI 1.01 to 1.52).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK roblingmr@cardiff.ac.uk.'}, {'ForeName': 'Fiona V', 'Initials': 'FV', 'LastName': 'Lugg-Widger', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cannings-John', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Lianna', 'Initials': 'L', 'LastName': 'Angel', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Fitzsimmons', 'Affiliation': 'Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Kenkre', 'Affiliation': 'Faculty of Life Sciences and Education, University of South Wales, Pontypridd, UK.'}, {'ForeName': 'Gwenllian', 'Initials': 'G', 'LastName': 'Moody', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Eleri', 'Initials': 'E', 'LastName': 'Owen-Jones', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rhys D', 'Initials': 'RD', 'LastName': 'Pockett', 'Affiliation': 'Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Segrott', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Slater', 'Affiliation': 'School of Social Sciences, Cardiff University, Cardiff, UK.'}]",BMJ open,['10.1136/bmjopen-2021-049960']
2019,35146511,"Erratum to: Roxadustat for the treatment of anaemia in chronic kidney disease patients not on dialysis: A Phase 3, randomised, open-label, active-controlled study (DOLOMITES).",,2022,,['chronic kidney disease patients not on dialysis'],[],[],"[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]",[],[],,0.0281403,,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Barratt', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Branislav', 'Initials': 'B', 'LastName': 'Andric', 'Affiliation': 'Health Center Krusevac, Krusevac, Serbia.'}, {'ForeName': 'Avtandil', 'Initials': 'A', 'LastName': 'Tataradze', 'Affiliation': 'National Center of Urology, Tbilisi, Georgia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schömig', 'Affiliation': 'Dialysis Center Heilbronn, Heilbronn, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Reusch', 'Affiliation': 'Astellas Pharma Europe B.V., Leiden, The Netherlands.'}, {'ForeName': 'Udaya', 'Initials': 'U', 'LastName': 'Valluri', 'Affiliation': 'Astellas Pharma Global Development, Inc., Northbrook, IL, USA.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Mariat', 'Affiliation': 'CHU St Etienne, Service Nephrologie Dialyse Transplantation, St Etienne, France.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfab349']
2020,35149167,Comparing the standard surgical dressing with dehydrated amnion and platelet-derived growth factor dressings in the healing rate of diabetic foot ulcer: A randomized clinical trial.,"AIMS


The management of diabetic foot ulcers is a challenging issue due to the pathophysiological background, delay in healing, and prevalence of diabetes. The purpose of this study was to compare the therapeutic effects of the three methods of diabetic wound care: surgical debridement and dressing, dressing with dehydrated amnion powder, and dressing with platelet-derived growth factor gel.
METHODS


In this multi-arm parallel-group randomized trial, 243 patients with a minimum 4-week medical history of diabetic foot ulcers with Wagner's grades 1 and 2, no infection, and adequate tissue blood flow were randomly assigned to one of three 81-person groups: surgical debridement (the standard method), dehydrated amnion dressing, or platelet-derived growth factor dressing. The follow-up period lasted 12 weeks. The percentage area reduction (PAR) was measured as the final target. SPSS version 25 was used to perform statistical analysis on the data.
RESULTS


All three study groups were comparable in terms of the type of ulcer, the area of ulcer, Wagner's grade, the period, and the ulcer's size. The PAR in the surgical debridement, platelet-derived growth factor, and dehydrated amnion groups were 7.4%, 14.8%, and 49.3% in week 4; 20.1%, 35.8%, and 79% in week 6; 43.7%, 56.8%, 86.4% in week 8; and 50%, 61.7%, and 87.6% in weeks 10 and 12, respectively. The observed differences were statistically significant (p < 0.05) over the entire period.
CONCLUSION


The study concluded that dehydrated amnion dressing, when compared to platelet-derived growth factor dressing and surgical debridement, resulted in better-improved healing in diabetic foot ulcer patients.",2022,"All three study groups were comparable in terms of the type of ulcer, the area of ulcer, Wagner's grade, the period, and the ulcer's size.","[""243 patients with a minimum 4-week medical history of diabetic foot ulcers with Wagner's grades 1 and 2, no infection, and adequate tissue blood flow"", 'diabetic foot ulcer patients', 'diabetic foot ulcer']","['standard surgical dressing with dehydrated amnion and platelet-derived growth factor dressings', 'surgical debridement (the standard method), dehydrated amnion dressing, or platelet-derived growth factor dressing', 'diabetic wound care: surgical debridement and dressing, dressing with dehydrated amnion powder, and dressing with platelet-derived growth factor gel']",['percentage area reduction (PAR'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C2712105', 'cui_str': 'Absence of signs and symptoms of infection'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3653515', 'cui_str': 'SURGICAL DRESSINGS'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0032200', 'cui_str': 'Platelet-derived growth factor'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4728046', 'cui_str': 'Diabetic wound'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",243.0,0.00906194,"All three study groups were comparable in terms of the type of ulcer, the area of ulcer, Wagner's grade, the period, and the ulcer's size.","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Mohammadi Tofigh', 'Affiliation': 'Department of General Surgery, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: arash_mtofigh@yahoo.com.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Tajik', 'Affiliation': 'Department of General Surgery, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2022.109775']
2021,35149566,"Investigating the efficacy and safety of elobixibat, an ileal bile acid transporter inhibitor, in patients with Parkinson's disease with chronic constipation: a multicentre, placebo-controlled, randomised, double-blind, parallel-group stud (CONST-PD).","INTRODUCTION


Chronic constipation worsens the quality of life (QOL) of patients with Parkinson's disease (PD). Elobixibat, an ileal bile acid transporter inhibitor, is a useful laxative, but its effect on chronic constipation in patients with PD remains unclear. Therefore, we designed a placebo-controlled, randomised, double-blind study to investigate the efficacy and safety of elobixibat in patients with PD with chronic constipation.
METHODS AND ANALYSIS


The study will consist of 2-week observation and 4-week treatment periods. Patients with clinically established PD will record the status of spontaneous bowel movements and use of rescue medications/concomitant medications in a Bowel Movement Diary from the start of the observation period at visit 1 (week -2). At visit 2 (week 0), patients will be assessed for final registration based on the diary records and physical examinations, and allocated to either the elobixibat or placebo group. Daily intake of the investigational drug will be recorded in the diary. Patients will undergo laboratory tests and answer constipation-related, PD-related and QOL-related questionnaires at visits 2 and 4 (week 4). Subjective symptoms and objective findings will be collected at visits 2, 3 (week 2) and 4. Since patients' motor function might be improved by treatment of constipation, the use of dopamine preparations will also be monitored. Bowel movement data and other parameters will be compared between groups.Safety information will be collected as adverse events, specifically focusing on those occurring in association with study conduct.
ETHICS AND DISSEMINATION


This study will be conducted in accordance with the Helsinki Declaration, the Clinical Trials Act of the Japan Ministry of Health, Labour and Welfare, and related laws and regulations. The study was approved by the Juntendo University Certified Review Board. The results will be disseminated through an online study registry (Japan Registry of Clinical Trials), presented at scientific conferences, and published in medical journals.
TRIAL REGISTRATION NUMBER


JPRN-jRCTs031200172; Pre-results.",2022,"At visit 2 (week 0), patients will be assessed for final registration based on the diary records and physical examinations, and allocated to either the elobixibat or placebo group.","['Patients with clinically established PD', ""patients with Parkinson's disease (PD"", 'patients with PD', ""patients with Parkinson's disease with chronic constipation"", 'patients with PD with chronic constipation']","['placebo', 'elobixibat', 'elobixibat or placebo']","['efficacy and safety', 'quality of life (QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3659266', 'cui_str': 'elobixibat'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.254093,"At visit 2 (week 0), patients will be assessed for final registration based on the diary records and physical examinations, and allocated to either the elobixibat or placebo group.","[{'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Hatano', 'Affiliation': 'Neurology, Juntendo Univerity Faculty of Medicine, Tokyo, Japan nhattori@juntendo.ac.jp thatano@juntendo.ac.jp.'}, {'ForeName': 'Genko', 'Initials': 'G', 'LastName': 'Oyama', 'Affiliation': 'Neurology, Juntendo Univerity Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Shimo', 'Affiliation': 'Neurology, Juntendo Nerima Hospital, Tokyo, Japan.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Ogaki', 'Affiliation': 'Neurology, Juntendo Urayasu Hospital, Urayasu, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Nishikawa', 'Affiliation': 'Neurology, Juntendo Univerity Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Fukae', 'Affiliation': 'Neurology, Juntendo Nerima Hospital, Tokyo, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'Neurology, Juntendo Urayasu Hospital, Urayasu, Japan.'}, {'ForeName': 'Naohide', 'Initials': 'N', 'LastName': 'Kurita', 'Affiliation': 'Neurology, Juntendo Urayasu Hospital, Urayasu, Japan.'}, {'ForeName': 'Taiji', 'Initials': 'T', 'LastName': 'Tsunemi', 'Affiliation': 'Neurology, Juntendo Univerity Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Oji', 'Affiliation': 'Neurology, Juntendo Univerity Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Saiki', 'Affiliation': 'Neurology, Juntendo Univerity Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Nishioka', 'Affiliation': 'Neurology, Juntendo Univerity Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Takeshige-Amano', 'Affiliation': 'Neurology, Juntendo Univerity Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Taniguchi', 'Affiliation': 'Neurology, Juntendo Univerity Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Neurology, Juntendo Univerity Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hikaru', 'Initials': 'H', 'LastName': 'Kamo', 'Affiliation': 'Neurology, Juntendo Univerity Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Eguchi', 'Affiliation': 'Neurology, Juntendo Nerima Hospital, Tokyo, Japan.'}, {'ForeName': 'Atsuhito', 'Initials': 'A', 'LastName': 'Fuse', 'Affiliation': 'Neurology, Juntendo Nerima Hospital, Tokyo, Japan.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Neurology, Juntendo Nerima Hospital, Tokyo, Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Kano', 'Affiliation': 'Neurology, Juntendo Nerima Hospital, Tokyo, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Nakajima', 'Affiliation': 'Neurology, Juntendo Urayasu Hospital, Urayasu, Japan.'}, {'ForeName': 'Naotake', 'Initials': 'N', 'LastName': 'Yanagisawa', 'Affiliation': 'Juntendo Clinical Research and Trial Center, Juntendo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Neurology, Juntendo Univerity Faculty of Medicine, Tokyo, Japan nhattori@juntendo.ac.jp thatano@juntendo.ac.jp.'}]",BMJ open,['10.1136/bmjopen-2021-054129']
2022,35149565,Comparison of dexmedetomidine and meperidine for the prevention of shivering following coronary artery bypass graft: study protocol of a randomised controlled trial.,"INTRODUCTION


Shivering is a common complication in the postoperative period. The incidence of shivering has been reported to range from 5% to 65% under general anaesthesia and as 33% during epidural anaesthesia. Shivering can increase perioperative risk in patients. Both dexmedetomidine and meperidine are effective agents for the prevention of postanaesthetic shivering. However, few studies have compared the anti-shivering effects of different agents following coronary artery bypass graft (CABG). This study aims to compare the effects of dexmedetomidine and meperidine on the incidence of shivering in patients undergoing CABG.
METHODS AND ANALYSIS


A total of 180 patients aged 18-75 years, with an American Society of Anesthesiologists (ASA) grade of II-IV, undergoing elective CABG will be enrolled and randomly assigned to the dexmedetomidine, meperidine and control groups (placebo) in an intended 1:1:1 allocation ratio. The patients will be followed up for 7 days after surgery. The primary outcome is the incidence of shivering within 24 hours postoperatively. The secondary outcomes are the number of remedial drugs used after surgery, the incidence of postoperative hypotension and bradycardia, sedation scores, endotracheal extubation time, intensive care unit length of stay, incidence of postoperative delirium within 7 days after surgery, incidence of postoperative arrhythmias, incidence of postoperative nausea and vomiting, average hospital length of stay and mortality rate 30 days after surgery.
ETHICS AND DISSEMINATION


The study protocol was approved by the ethics committee of The First Affiliated Hospital of Shandong First Medical University on 20 January 2021 (YXLL-KY-2021(002)) and registered at ClinicalTrials.gov. The results of this study will be presented at national and international scientific meetings and conferences. We plan to publish the data in peer-reviewed international scientific journals.
TRIAL REGISTRATION NUMBER


NCT04735965.",2022,Both dexmedetomidine and meperidine are effective agents for the prevention of postanaesthetic shivering.,"['ethics committee of The First Affiliated Hospital of Shandong First Medical University on 20 January 2021 (YXLL-KY-2021(002)) and registered at ClinicalTrials.gov', 'patients', '180 patients aged 18-75 years, with an American Society of Anesthesiologists (ASA) grade of II-IV, undergoing elective CABG', 'shivering following coronary artery bypass graft', 'patients undergoing CABG']","['dexmedetomidine', 'dexmedetomidine and meperidine', 'dexmedetomidine, meperidine and control groups (placebo', 'meperidine']","['number of remedial drugs used after surgery, the incidence of postoperative hypotension and bradycardia, sedation scores, endotracheal extubation time, intensive care unit length of stay, incidence of postoperative delirium within 7\u2009days after surgery, incidence of postoperative arrhythmias, incidence of postoperative nausea and vomiting, average hospital length of stay and mortality rate 30 days after surgery', 'incidence of shivering within 24\u2009hours postoperatively', 'incidence of shivering']","[{'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0865752', 'cui_str': 'Postoperative hypotension'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]",180.0,0.20023,Both dexmedetomidine and meperidine are effective agents for the prevention of postanaesthetic shivering.,"[{'ForeName': 'Cuicui', 'Initials': 'C', 'LastName': 'Cao', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Lv', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong, China.'}, {'ForeName': 'Chuansong', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong, China.'}, {'ForeName': 'Yuelan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong, China.'}, {'ForeName': 'Changping', 'Initials': 'C', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong, China changpinggu@163.com.'}]",BMJ open,['10.1136/bmjopen-2021-053865']
2023,35149535,"Human papillomavirus vaccine efficacy against invasive, HPV-positive cancers: population-based follow-up of a cluster-randomised trial.","BACKGROUND


Human papillomavirus (HPV) vaccination protects against HPV, a necessary risk factor for cervical cancer. We now report results from population-based follow-up of randomised cohorts that vaccination provides HPV-type-specific protection against invasive cancer.
METHODS


Individually and/or cluster randomised cohorts of HPV-vaccinated and non-vaccinated women were enrolled in 2002-2005. HPV vaccine cohorts comprised originally 16-17 year-old HPV 16/18-vaccinated PATRICIA (NCT00122681) and 012 trial (NCT00169494) participants (2465) and HPV6/11/16/18-vaccinated FUTURE II (NCT00092534) participants (866). Altogether, 3341 vaccines were followed by the Finnish Cancer Registry in the same way as 16 526 non-HPV-vaccinated controls. The control cohort stemmed from 15 665 originally 18-19 years-old women enrolled in 2003 (6499) or 2005 (9166) and 861 placebo recipients of the FUTURE II trial. The follow-up started 6 months after the clinical trials in 2007 and 2009 and ended in 2019. It was age aligned for the cohorts.
FINDINGS


During a follow-up time of up to 11 years, we identified 17 HPV-positive invasive cancer cases (14 cervical cancers, 1 vaginal cancer, 1 vulvar cancer and 1 tongue cancer) in the non-HPV-vaccinated cohorts and no cases in the HPV-vaccinated cohorts. HPV typing of diagnostic tumour blocks found HPV16 in nine cervical cancer cases, HPV18, HPV33 and HPV52 each in two cases and HPV45 in one cervical cancer case. The vaginal, vulvar and tongue cancer cases were, respectively, positive for HPV16, HPV52/66 and HPV213. Intention-to-treat vaccine efficacy against all HPV-positive cancers was 100% (95% CI 2 to 100, p<0.05).
INTERPRETATION


Vaccination is effective against invasive HPV-positive cancer.
TRIAL REGISTRATION NUMBER


NCT00122681, Post-results; NCT00169494, Post-results; NCT00092534, Post-results.",2021,"Intention-to-treat vaccine efficacy against all HPV-positive cancers was 100% (95% CI 2 to 100, p<0.05).
","['and non-vaccinated women were enrolled in 2002-2005', '15\u2009665 originally 18-19\u2009years-old women enrolled in 2003 (6499) or 2005 (9166) and 861 placebo recipients of the FUTURE II trial', '17 HPV-positive invasive cancer cases (14 cervical cancers, 1 vaginal cancer, 1 vulvar cancer and 1 tongue cancer) in the non-HPV-vaccinated cohorts and no cases in the HPV-vaccinated cohorts', 'HPV-positive cancers']","['HPV vaccine', 'HPV-vaccinated']",['Intention-to-treat vaccine efficacy against all HPV-positive cancers'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517848', 'cui_str': '665'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0042237', 'cui_str': 'Malignant tumor of vagina'}, {'cui': 'C0375071', 'cui_str': 'Malignant tumor of vulva'}, {'cui': 'C0153349', 'cui_str': 'Malignant tumor of tongue'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}]","[{'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",9.0,0.416418,"Intention-to-treat vaccine efficacy against all HPV-positive cancers was 100% (95% CI 2 to 100, p<0.05).
","[{'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Lehtinen', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden inkeri.lehtinen@gmail.com.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Lagheden', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Tapio', 'Initials': 'T', 'LastName': 'Luostarinen', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Eriksson', 'Affiliation': 'FICAN-Mid, Tampere, Finland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Apter', 'Affiliation': 'VL Medi, Helsinki, Finland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bly', 'Affiliation': 'Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Gray', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Harjula', 'Affiliation': 'Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Heikkilä', 'Affiliation': 'Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hokkanen', 'Affiliation': 'Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Karttunen', 'Affiliation': 'Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Marjo', 'Initials': 'M', 'LastName': 'Kuortti', 'Affiliation': 'Faculty of Social Sciences, Tampereen Yliopisto, Tampere, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Nieminen', 'Affiliation': 'Helsingin Yliopisto, Helsinki, Finland.'}, {'ForeName': 'Mervi', 'Initials': 'M', 'LastName': 'Nummela', 'Affiliation': 'Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Paavonen', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Palmroth', 'Affiliation': 'University of Eastern Finland School of Medicine, Kuopio, Pohjois-Savo, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Petäjä', 'Affiliation': 'Obstetrics & Gynecology, Tampereen Yliopisto, Seinäjoki, Finland.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Pukkala', 'Affiliation': 'Cancer Society of Finland, Helsinki, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Soderlund-Strand', 'Affiliation': 'Clinical Microbiology, Lund University, Lund, Sweden.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Veivo', 'Affiliation': 'Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Dillner', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}]",BMJ open,['10.1136/bmjopen-2021-050669']
2024,35149429,"Efficacy, safety and quality-of-life data from patients with pre-treated metastatic colorectal cancer receiving trifluridine/tipiracil: results of the TALLISUR trial.","INTRODUCTION


Trifluridine/tipiracil (FTD/TPI) improved both overall and progression-free survival (OS, PFS) of patients with pre-treated metastatic colorectal cancer (mCRC) in the pivotal phase III RECOURSE trial. However, health-related quality of life (HRQoL) was not assessed directly. To this end and to generate post-authorisation data, the TALLISUR trial was conducted.
METHODS


In this prospective, multi-centre, Germany-wide, phase IV study, patients with pre-treated mCRC were given the choice to receive either FTD/TPI or best supportive care (BSC). A validated questionnaire, EORTC QLQ-C30, was employed to assess HRQoL. Secondary endpoints included OS, PFS and safety.
RESULTS


Of 194 eligible patients, 185 decided to receive FTD/TPI and 9 to receive BSC. The low number of patients in the BSC-arm did not allow statistically meaningful analyses. On the other hand, treatment with FTD/TPI was associated with maintained HRQoL. Median OS was 6.9 months [95% confidence interval (CI) 6.1-8.2 months] and median PFS was 2.5 months (95% CI 2.1-2.9 months). The most frequent treatment-emergent adverse events were neutropenia (27.6%) and anaemia (22.7%). Febrile neutropenia occurred in 1.1%.
CONCLUSIONS


Treatment of patients suffering from pre-treated mCRC with FTD/TPI was associated not only with prolonged survival and delayed progression but also with maintained HRQoL.",2022,"A validated questionnaire, EORTC QLQ-C30, was employed to assess HRQoL. Secondary endpoints included OS, PFS and safety.
","['patients with pre-treated metastatic colorectal cancer receiving', '194 eligible patients', 'patients with pre-treated metastatic colorectal cancer (mCRC']","['HRQoL', 'FTD/TPI and 9 to receive BSC', 'Trifluridine/tipiracil (FTD/TPI', 'trifluridine/tipiracil', 'FTD/TPI or best supportive care (BSC']","['Efficacy, safety and quality-of-life data', 'health-related quality of life (HRQoL', 'Febrile neutropenia', 'prolonged survival and delayed progression', 'neutropenia', 'maintained HRQoL. Median OS', 'OS, PFS and safety', 'anaemia', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0338451', 'cui_str': 'Frontotemporal dementia'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C4055631', 'cui_str': 'Tipiracil- and trifluridine-containing product'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",194.0,0.0800517,"A validated questionnaire, EORTC QLQ-C30, was employed to assess HRQoL. Secondary endpoints included OS, PFS and safety.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Weiss', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Karthaus', 'Affiliation': 'Clinic for Haematology and Oncology, Klinikum Neuperlach, Munich, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Riera-Knorrenschild', 'Affiliation': 'University Hospital of Giessen and Marburg, Marburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kretzschmar', 'Affiliation': 'MVZ Mitte Leipzig, Leipzig, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Welslau', 'Affiliation': 'Praxis Aschaffenburg, Aschaffenburg, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Vehling-Kaiser', 'Affiliation': 'Praxis für Hämatologie/Onkologie, Landshut, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Pelz', 'Affiliation': 'Ambulantes Therapiezentrum für Hämatologie und Onkologie, Offenburg, Germany.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Ettrich', 'Affiliation': 'Ludwig Maximilian University (LMU) Munich.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hess', 'Affiliation': 'SERVIER Deutschland GmbH, Medical Affairs, Munich, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Reisländer', 'Affiliation': 'SERVIER Deutschland GmbH, Medical Affairs, Munich, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Klein', 'Affiliation': 'SERVIER Deutschland GmbH, Medical Affairs, Munich, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU) Munich, Munich, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",ESMO open,['10.1016/j.esmoop.2022.100391']
2025,35149266,Neurophysiological outcomes following mesenchymal stem cell therapy in multiple sclerosis.,"OBJECTIVE


To report on neurophysiological outcomes derived from transcranial magnetic stimulation (TMS) following autologous mesenchymal stem cells (aMSCs) therapy in patients with multiple sclerosis (MS).
METHODS


20 adults with confirmed MS were recruited to participate in a phase II randomized control trial to assess the safety and potential benefits of aMSCs infusion. At Week 0, patients were randomly assigned to receive either aMSCs (n = 9) or a placebo infusion (n = 11). At Week 24, the placebo group received the aMSCs infusion. Blind assessments were performed at Weeks 0, 24 and 48. Outcomes consisted of TMS measures of corticomotor excitability and motor conduction along with measures of motor impairments and disability.
RESULTS


Post-infusion, no change was detected in measures of corticomotor excitability or measures of intra- or interhemispheric inhibition. The latency of motor evoked potentials and central motor conduction time were significantly prolonged. These changes in motor conduction were associated with declines in hand dexterity post-infusion.
CONCLUSION


Clinical and neurophysiological measures showed no improvement following aMSCs therapy in this cohort of MS patients.
SIGNIFICANCE


Although promising, stem cell therapy remains elusive regarding its benefits in influencing disease activity in MS patients.",2022,The latency of motor evoked potentials and central motor conduction time were significantly prolonged.,"['MS patients', 'multiple sclerosis', 'patients with multiple sclerosis (MS', '20 adults with confirmed MS']","['placebo', 'TMS', 'autologous mesenchymal stem cells (aMSCs) therapy', 'placebo infusion', 'mesenchymal stem cell therapy', 'aMSCs', 'aMSCs infusion', 'transcranial magnetic stimulation (TMS']","['motor conduction', 'corticomotor excitability and motor conduction along with measures of motor impairments and disability', 'latency of motor evoked potentials and central motor conduction time', 'Neurophysiological outcomes', 'corticomotor excitability or measures of intra- or interhemispheric inhibition']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",20.0,0.105027,The latency of motor evoked potentials and central motor conduction time were significantly prolonged.,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Tremblay', 'Affiliation': 'School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa, Ont., Canada K1H 8M5; Bruyère Research Institute, Ottawa, Ont., Canada K1N 5C8. Electronic address: ftrembla@uottawa.ca.'}, {'ForeName': 'Yekta', 'Initials': 'Y', 'LastName': 'Ansari', 'Affiliation': 'Bruyère Research Institute, Ottawa, Ont., Canada K1N 5C8. Electronic address: yansa084@uottawa.ca.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Remaud', 'Affiliation': 'Bruyère Research Institute, Ottawa, Ont., Canada K1N 5C8. Electronic address: anthony.remaud@hotmail.com.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'University of Ottawa, Department of Medicine, and the Ottawa Hospital Research Institute, Ottawa, Ont. Canada K1H 8L6. Electronic address: MFREEDMAN@toh.ca.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2022.01.125']
2026,35149238,Topical use of hyperoxygenated fatty acids decreases surgical site infection in patients following laparoscopic cholecystectomy. A randomized controlled trial.,"BACKGROUND


To date, the topically effect of hyperoxygenated fatty acids (HOFA) on the control of surgical site infection (SSI) is still unclear.
OBJECTIVE


To assess the effect of topical application of a HOFA solution on the umbilical trocar site after laparoscopic cholecystectomy on SSI. The occurrence of trocar site incisional hernia (TSIH) was also analyzed.
METHODS


A prospective, double-blind, randomized trial was conducted in patients undergoing laparoscopic cholecystectomy, who also presented at least one of the following associated risk factors for SSI and TSIH such as Body Mass Index (BMI) above 30 kg/m 2 , Diabetes Mellitus (DM), age over 65 years and Chronic Obstructive Pulmonary Disease (COPD). Patients were randomly allocated to topical application of a HOFA solution (HOFA arm) or saline physiological solution (non-HOFA arm) during closure of the umbilical trocar site with a polypropylene mesh. SSI was the primary outcome. TSIH was also assessed as a secondary outcome.
RESULTS


103 patients were included, 51 (49.5%) in the HOFA group and 52 (50.5%) in the non-HOFA group. SSI rate was significantly lower in the HOFA group in comparison with the non-HOFA group (19.6% vs. 3.8%; p = 0.028). TSIH rates were similar in both groups (3.8% vs. 2%). Multivariate analyses showed that only HOFA decreased significantly SSI rate.
CONCLUSION


Topical application of a HOFA solution at the umbilical trocar site after laparoscopy cholecystectomy decreased SSI rate.",2022,SSI rate was significantly lower in the HOFA group in comparison with the non-HOFA group (19.6% vs. 3.8%; p = 0.028).,"['patients undergoing laparoscopic cholecystectomy, who also presented at least one of the following associated risk factors for SSI and TSIH such as Body Mass Index (BMI) above 30\u202fkg/m 2 , Diabetes Mellitus (DM), age over 65 years and Chronic Obstructive Pulmonary Disease (COPD', 'patients following laparoscopic cholecystectomy', '103 patients were included, 51 (49.5%) in the HOFA group and 52 (50.5%) in the non-HOFA group', 'umbilical trocar site after laparoscopic cholecystectomy on SSI']","['HOFA', 'HOFA solution', 'hyperoxygenated fatty acids (HOFA', 'hyperoxygenated fatty acids', 'HOFA solution (HOFA arm) or saline physiological solution (non-HOFA arm) during closure of the umbilical trocar site with a polypropylene mesh']","['SSI rate', 'TSIH rates', 'occurrence of trocar site incisional hernia (TSIH', 'TSIH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1321585', 'cui_str': 'Polypropylene mesh'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",103.0,0.205223,SSI rate was significantly lower in the HOFA group in comparison with the non-HOFA group (19.6% vs. 3.8%; p = 0.028).,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bellón López de Antón Bueno', 'Affiliation': 'General University Hospital of Elche, Camino de la Almazara 11, 03203, Elche, Alicante, Spain. Electronic address: mbellonlopez@gmail.com.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Murcia López', 'Affiliation': 'General University Hospital of Elche, Camino de la Almazara 11, 03203, Elche, Alicante, Spain. Electronic address: anamu26@yahoo.es.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Galiana Cabrera', 'Affiliation': 'General University Hospital of Elche, Camino de la Almazara 11, 03203, Elche, Alicante, Spain. Electronic address: antoniogaliana1@gmail.com.'}, {'ForeName': 'José Alberto', 'Initials': 'JA', 'LastName': 'García Gómez', 'Affiliation': 'General University Hospital of Elche, Camino de la Almazara 11, 03203, Elche, Alicante, Spain. Electronic address: codicealberto@gmail.com.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Calero Amaro', 'Affiliation': 'General University Hospital of Elche, Camino de la Almazara 11, 03203, Elche, Alicante, Spain. Electronic address: alidoc20@yahoo.es.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Díaz Lara', 'Affiliation': 'General University Hospital of Elche, Camino de la Almazara 11, 03203, Elche, Alicante, Spain. Electronic address: carlosdiazlara@gmail.com.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Arroyo Sebastián', 'Affiliation': 'General University Hospital of Elche, Camino de la Almazara 11, 03203, Elche, Alicante, Spain. Electronic address: arroyocir@hotmail.com.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'Lacueva Gómez', 'Affiliation': 'General University Hospital of Elche, Camino de la Almazara 11, 03203, Elche, Alicante, Spain. Electronic address: fj.lacueva@umh.es.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Armañanzas Ruiz', 'Affiliation': 'General University Hospital of Elche, Camino de la Almazara 11, 03203, Elche, Alicante, Spain. Electronic address: laura.armananzas@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2022.106253']
2027,35150143,Does nano-curcumin supplementation improve hematological indices in critically ill patients with sepsis? A randomized controlled clinical trial.,"Sepsis is the final common pathway to death for severe infectious diseases worldwide. The present trial aimed to investigate the effects of nano-curcumin supplementation on hematological indices in critically ill patients with sepsis. Fourteen ICU-admitted patients were randomly allocated into either nano-curcumin or placebo group for 10 days. The blood indices, serum levels of inflammatory biomarker and presepsin as well as nutrition status, and clinical outcomes were assessed before the intervention and on days 5 and 10. White blood cells, neutrophils, platelets, erythrocyte sedimentation rate (ESR), and the levels of interleukin-8 significantly decreased in the nano-curcumin group compared to the placebo after 10 days of intervention (p = .024, p = .045, p = .017, p = .041, and p = .004, respectively). There was also a marginal meaningful decrease in serum presepsin levels in the intervention group compared to the placebo at the end of the study (p = .054). However, total lymphocyte count showed a significant increase in the nano-curcumin group compared to the placebo at the end-point (p = .04). No significant differences were found in the level of lymphocyte and the ratios of neutrophil/lymphocyte and platelet/lymphocyte between the study groups. Moreover, no significant between-group differences were observed for other study outcomes, post-intervention. Collectively, nano-curcumin may be a useful adjuvant therapy in critically ill patients with sepsis. However, further trials are suggested to examine the effects of nano-curcumin in the management of sepsis and its complications. PRACTICAL APPLICATIONS: Curcumin (1,7-bis[4-hydroxy-3-methoxyphenyl]-1,6-heptadiene-3,5- dione) or diferuloylmethane is widely used in medicine due to its several biological properties. Recent evidence has shown that curcumin possesses multiple pharmacological activities including immune-modulatory, antioxidant, anti-inflammatory, anti-cancer, and anti-microbial effects. In this study, it was observed that nano-curcumin at a dose of 160 mg for 10 days, without side effects, reduced some inflammatory factors and regulated the immune responses in sepsis patients. For the first time, this trial was conducted to determine the effect of nano-curcumin on hematological indices and the serum levels of presepsin and IL-8.",2022,No significant differences were found in the level of lymphocyte and the ratios of neutrophil/lymphocyte and platelet/lymphocyte between the study groups.,"['Fourteen ICU-admitted patients', 'critically ill patients with sepsis']","['placebo', 'nano-curcumin', 'nano-curcumin supplementation', 'nano-curcumin or placebo', 'Curcumin (1,7-bis[4-hydroxy-3-methoxyphenyl]-1,6-heptadiene-3,5- dione) or diferuloylmethane', 'curcumin supplementation']","['blood indices, serum levels of inflammatory biomarker and presepsin as well as nutrition status, and clinical outcomes', 'White blood cells, neutrophils, platelets, erythrocyte sedimentation rate (ESR), and the levels of interleukin-8', 'total lymphocyte count', 'hematological indices and the serum levels of presepsin and IL-8', 'serum presepsin levels', 'level of lymphocyte and the ratios of neutrophil/lymphocyte and platelet/lymphocyte', 'hematological indices']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.128465,No significant differences were found in the level of lymphocyte and the ratios of neutrophil/lymphocyte and platelet/lymphocyte between the study groups.,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Naeini', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Helda', 'Initials': 'H', 'LastName': 'Tutunchi', 'Affiliation': 'Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Razmi', 'Affiliation': 'Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Mahmoodpoor', 'Affiliation': 'Department of Anatomical Sciences, Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Vajdi', 'Affiliation': 'Student Research Committee, Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Pouria', 'Initials': 'P', 'LastName': 'Sefidmooye Azar', 'Affiliation': 'Department of Nutrition and Hospitality Management, School of Applied Sciences, The University of Mississippi, University Park, Mississippi, USA.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Najifipour', 'Affiliation': 'Endoceine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tarighat-Esfanjani', 'Affiliation': 'Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Karimi', 'Affiliation': 'Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of food biochemistry,['10.1111/jfbc.14093']
2028,35150590,"Effect of Denture Hygiene Protocols on Patient Satisfaction, Oral Health-Related Quality of Life, and Salivary Parameters: A Randomized Clinical Trial.","PURPOSE


This randomized controlled trial compared four denture hygiene protocols in terms of patient satisfaction, oral health-related quality of life (OHRQoL), and salivary parameters in complete denture wearers with denture stomatitis.
MATERIAL AND METHODS


For this randomized, double-blind, controlled clinical trial, 108 participants were assigned to soak their dentures in one of the following solutions: (1) 0.25% sodium hypochlorite (positive control), (2) 0.15% Triclosan, (3) denture disinfecting tablets, or (4) denture disinfecting tablets plus palatine mucosa brushing solution. The outcomes of patient satisfaction, OHRQoL, and salivary parameters (salivary flow rate and pH) were measured at baseline and after 10 days. The Kruskal-Wallis and Dunn tests (between groups), and Wilcoxon test (between times) were used to compare the results. (α = 0.05).
RESULTS


After the hygiene protocols, and when compared with baseline, the overall patient satisfaction, maxillary denture satisfaction, maxillary denture comfort, and maxillary denture retention were ameliorated. A significant improvement was noted in OHRQoL in 3 of 4 domains evaluated (orofacial pain and discomfort, masticatory discomfort and disability, and psychological disability and discomfort). The salivary flow rate (unstimulated and stimulated) and salivary pH were not significantly affected at the times evaluated.
CONCLUSIONS


Complete denture wearers may feel more satisfied with their complete dentures when treated for denture stomatitis. The tested treatments lead to similar improvement in terms of patient satisfaction and OHRQoL.",2022,"A significant improvement was noted in OHRQoL in 3 of 4 domains evaluated (orofacial pain and discomfort, masticatory discomfort and disability, and psychological disability and discomfort).","['108 participants were assigned to soak their dentures in one of the following solutions: (1) 0.25', 'complete denture wearers with denture stomatitis']","['Denture Hygiene Protocols', 'sodium hypochlorite (positive control), (2) 0.15% Triclosan, (3) denture disinfecting tablets, or (4) denture disinfecting tablets plus palatine mucosa brushing solution']","['overall patient satisfaction, maxillary denture satisfaction, maxillary denture comfort, and maxillary denture retention', 'Patient Satisfaction, Oral Health-Related Quality Of Life, and Salivary Parameters', 'orofacial pain and discomfort, masticatory discomfort and disability, and psychological disability and discomfort', 'salivary flow rate', 'patient satisfaction and OHRQoL', 'patient satisfaction, OHRQoL, and salivary parameters (salivary flow rate and pH', 'OHRQoL', 'patient satisfaction, oral health-related quality of life (OHRQoL), and salivary parameters']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0038364', 'cui_str': 'Denture stomatitis'}]","[{'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011397', 'cui_str': 'Denture Retention'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0178782', 'cui_str': 'Orofacial Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate'}]",108.0,0.251397,"A significant improvement was noted in OHRQoL in 3 of 4 domains evaluated (orofacial pain and discomfort, masticatory discomfort and disability, and psychological disability and discomfort).","[{'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Barbosa Ribeiro', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Borba Araújo', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Vieira Fortes', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lucarini Bueno', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'de Cássia Oliveira', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Macedo', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'de Freitas Oliveira Paranhos', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'Watanabe', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'De Wever', 'Affiliation': 'Bonyf AG, Vaduz, Liechtenstein.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Helena Silva-Lovato', 'Affiliation': 'Department of Dental Materials and Prothesis; School of Dentistry of Ribeirao Preto, University of Sao Paulo (USP), Ribeirão Preto, SP, Brazil.'}]",Journal of prosthodontics : official journal of the American College of Prosthodontists,['10.1111/jopr.13494']
2029,35150818,The effect of purple-black barberry (Berberis integerrima) on blood pressure in subjects with cardiovascular risk factors: a randomized controlled trial.,"ETHNOPHARMACOLOGICAL RELEVANCE


Berberis integerrima commonly known as ""barberry"" belongs to the Berberidaceae family and has been used as a medicinal plant in Iranian traditional medicine.
AIM OF THE STUDY


Our aim in this study was to investigate the effects of barberry consumption on blood pressure (BP).
MATERIALS AND METHODS


Eighty-four medicated hypertensive patients were selected and randomly allocated to barberry and placebo groups. The barberry group received 10 g/day dried purple-black barberry powder, once daily, for 2-months. Systolic, diastolic, and mean arterial BP was assessed through 24-h ambulatory BP monitoring before and after 2-month treatment. The estimation of sodium and potassium intake was done through measurement of sodium and potassium in 24-h urinary samples. Plasma and urinary nitrite, and nitrate (NOx) levels, as well as plasma angiotensin-converting enzyme (ACE) activity, were also determined.
RESULTS


Seventy-eight participants with an average age of 54.12 ± 10.32 years and BMI of 27.93 ± 2.22 kg/m 2  completed the study. There was no significant difference in body weight, physical activity, and the 24-h urinary sodium and potassium excretion between the two groups before and after the study. After adjusting for baseline values and changes in sodium intake, systolic, and mean arterial BP decreased significantly in the barberry group compared to the placebo group (p = 0.015 and p = 0.008, respectively). Plasma NOx levels and ACE activity were not different between the two groups, but urinary NOx was increased significantly in the barberry group compared to the placebo group (p = 0.008).
CONCLUSIONS


In patients treated with antihypertensive drugs, daily consumption of purple-black barberry can be effective in improving systolic BP control.",2022,"Plasma NOx levels and ACE activity were not different between the two groups, but urinary NOx was increased significantly in the barberry group compared to the placebo group (p = 0.008).
","['subjects with cardiovascular risk factors', 'Seventy-eight participants with an average age of 54.12\u202f±\u202f10.32 years and BMI of 27.93\u202f±\u202f2.22\u202fkg/m 2  completed the study', 'Eighty-four medicated hypertensive patients']","['placebo', '10\u202fg/day dried purple-black barberry powder', 'purple-black barberry (Berberis integerrima']","['blood pressure', 'blood pressure (BP', 'Plasma and urinary nitrite, and nitrate (NOx) levels, as well as plasma angiotensin-converting enzyme (ACE) activity', 'Plasma NOx levels and ACE activity', 'sodium intake, systolic, and mean arterial BP', 'body weight, physical activity, and the 24-hours urinary sodium and potassium excretion', 'Systolic, diastolic, and mean arterial BP', 'urinary NOx', 'systolic BP control']","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0439542', 'cui_str': 'Purple'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0873066', 'cui_str': 'Barberry Extract'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0949843', 'cui_str': 'Barberry'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",78.0,0.0562653,"Plasma NOx levels and ACE activity were not different between the two groups, but urinary NOx was increased significantly in the barberry group compared to the placebo group (p = 0.008).
","[{'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Emamat', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Hadiemamat@yahoo.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zahedmehr', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaei Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran. Electronic address: arashzahedmehr@gmail.com.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Asadian', 'Affiliation': 'Department of Radiology, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran. Electronic address: asadian_s@yahoo.com.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Nasrollahzadeh', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: jnasrollahzadeh@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2022.115097']
2030,35151021,Evaluating the efficacy of common humanity-enhanced exposure for socially anxious young adults.,"Despite some evidence of the benefits of self-compassion training among socially anxious individuals, little is known about whether enhancing self-compassion prior to exposure therapy increases initial exposure engagement. Additionally, manipulations have relied on broad definitions of self-compassion, rendering it difficult to distinguish the impact of individual components. This study employed three experiential exercises designed to enhance one facet of self-compassion-common humanity. Socially anxious undergraduates (N = 63) were randomized in groups to 1) common humanity-enhanced exposure (n = 32) or 2) exposure alone (n = 31). In the common humanity condition, participants wrote self-compassionately, shared fears, and completed a common humanity-focused lovingkindness meditation. All participants then completed a speech exposure in front of live judges followed by an optional second exposure. Within the common humanity condition, positive self-responding to the speech exposure increased (b = 0.30, p = .026). Common humanity participants also remained in the first exposure longer, relative to exposure alone (b = -30.92, p = .002). Participants rated exercises as at least moderately helpful, with sharing fears rated most helpful. In sum, a brief group-based multi-modal common humanity induction represents a promising approach to improving initial engagement with feared contexts among socially anxious individuals.",2022,"Common humanity participants also remained in the first exposure longer, relative to exposure alone (b = -30.92, p = .002).","['socially anxious individuals', 'Socially anxious undergraduates (N\xa0=\xa063', 'socially anxious young adults']","['common humanity-enhanced exposure', 'humanity-enhanced exposure (n\xa0=\xa032) or 2) exposure alone']",['positive self-responding to the speech exposure'],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0020157', 'cui_str': 'Humanities'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",63.0,0.101043,"Common humanity participants also remained in the first exposure longer, relative to exposure alone (b = -30.92, p = .002).","[{'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Slivjak', 'Affiliation': 'University of Colorado Boulder, Department of Psychology and Neuroscience, Boulder, CO, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Pedersen', 'Affiliation': 'University of Colorado Boulder, Department of Psychology and Neuroscience, Boulder, CO, USA.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Arch', 'Affiliation': 'University of Colorado Boulder, Department of Psychology and Neuroscience, Boulder, CO, USA. Electronic address: Joanna.Arch@Colorado.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2022.102542']
2031,35151504,Evaluating the effectiveness of bupropion and varenicline for smoking cessation using an internet-based delivery system: A pragmatic randomized controlled trial (MATCH study).,"BACKGROUND


Traditional randomized controlled trials have demonstrated the efficacy of pharmacotherapy for smoking cessation. However, accessibility to treatments remains a barrier, necessitating the remote delivery of evidence-based cessation interventions. The aim of this study was to evaluate the effectiveness of an online treatment that included first-line prescription medications using a pragmatic randomized controlled trial design.
METHODS


This study was a two-group, parallel block randomized, open label, controlled trial, and conducted exclusively online. Participants were randomised (1:1) to either bupropion (150 mg) or varenicline (1 mg) for twelve weeks. Medication was couriered to participants. The primary outcome was 7-day point prevalence abstinence (PPA; defined as 0 cigarette puffs in the last 7 days) at 12 weeks. Secondary outcomes were 7-day PPA at 4-, 8-, 26-, and 52-weeks follow-up. Adverse events were evaluated at each follow-up session during treatment.
RESULTS


The varenicline group (n = 499) had significantly higher 7-day PPA (30.3%) compared to the bupropion group (n = 465; 19.6%) at end of treatment (OR=2.08, 95% CI: 1.49-2.90, p < 0.001). Seven-day PPA was also higher for the varenicline group at 4-weeks (OR=1.71, 95% CI: 1.23-2.40 p = 0.0001), and 8-weeks follow-up (OR=1.95, 95% CI: 1.43-2.67 p < 0.0001), but not at post-treatment follow-up. More adverse events were reported in the varenicline group, compared to bupropion.
CONCLUSIONS


This internet-based pharmacotherapy intervention was a feasible and effective method of treatment delivery for smoking cessation. This method can be used to increase the accessibility and availability of cessation interventions, decreasing the burden of smoking-related diseases.
TRIAL REGISTRATION


This trial was registered with clinical trials.gov under NCT02146911. Registered 26 May 2014, https://clinicaltrials.gov/ct2/show/NCT02146911.",2022,Seven-day PPA was also higher for the varenicline group at 4-weeks,[],"['bupropion', 'bupropion and varenicline', 'varenicline', 'pharmacotherapy intervention', 'pharmacotherapy']","['7-day PPA', 'Adverse events', 'adverse events', '7-day point prevalence abstinence (PPA']",[],"[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.267767,Seven-day PPA was also higher for the varenicline group at 4-weeks,"[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Nicotine Dependence Service, Addictions Program, Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada. Electronic address: helena.zhang@camh.ca.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Mansoursadeghi-Gilan', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada. Electronic address: Tara.ms@hotmail.com.'}, {'ForeName': 'Sarwar', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Nicotine Dependence Service, Addictions Program, Centre for Addiction and Mental Health, Toronto, ON, Canada. Electronic address: sarwar.hussain@camh.ca.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Veldhuizen', 'Affiliation': 'Nicotine Dependence Service, Addictions Program, Centre for Addiction and Mental Health, Toronto, ON, Canada. Electronic address: scott.veldhuizen@camh.ca.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada; Acute Care Program, Centre for Addiction and Mental Health, Toronto, ON, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada. Electronic address: bernard.lefoll@camh.ca.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Selby', 'Affiliation': 'Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Acute Care Program, Centre for Addiction and Mental Health, Toronto, ON, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada. Electronic address: peter.selby@camh.ca.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Zawertailo', 'Affiliation': 'Nicotine Dependence Service, Addictions Program, Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada. Electronic address: laurie.zawertailo@camh.ca.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2022.109312']
2032,35151415,"Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): follow-up analysis of a randomised, phase 3 study.","BACKGROUND


The primary analysis of the ICARIA-MM study showed significant improvement in progression-free survival with addition of isatuximab to pomalidomide-dexamethasone in relapsed and refractory multiple myeloma. Here, we report a prespecified updated overall survival analysis at 24 months after the primary analysis.
METHODS


In this randomised, multicentre, open-label, phase 3 study adult patients (aged ≥18 years) with relapsed and refractory multiple myeloma who had received at least two previous lines of therapy, including lenalidomide and a proteasome inhibitor, and had an Eastern Cooperative Oncology Group performance status of 0-2 were recruited from 102 hospitals in 24 countries across Europe, North America, and the Asia-Pacific regions. Patients were excluded if they had anti-CD38 refractory disease or previously received pomalidomide. Patients were randomly assigned (1:1), using an interactive response technology with permuted blocked randomisation (block size of four) and stratified by number of previous treatment lines (2-3 vs >3) and aged (<75 vs ≥75 years), to isatuximab-pomalidomide-dexamethasone (isatuximab group) or pomalidomide-dexamethasone (control group). In the isatuximab group, intravenous isatuximab 10 mg/kg was administered on days 1, 8, 15, and 22 of the first 4-week cycle, and then on days 1 and 15 of subsequent cycles. Both groups received oral pomalidomide 4 mg on days 1-21 of each cycle, and weekly oral or intravenous dexamethasone 40 mg (20 mg if aged ≥75 years) on days 1, 8, 15, and 22 of each cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent. Here' we report a prespecified second interim analysis of overall survival (time from randomisation to any-cause death), a key secondary endpoint, in the intention-to-treat population (ie, all patients who provided informed consent and allocated a randomisation number) at 24 months after the primary analysis. Safety was assessed in all patients who received at least one dose or part dose of study treatment. The prespecified stopping boundary for the overall survival analysis was when the derived p value was equal to or less than 0·0181. This study is registered with ClinicalTrials.gov, NCT02990338, and is active, but not recruiting.
FINDINGS


Between Jan 10, 2017, and Feb 2, 2018, 387 patients were screened and 307 randomly assigned to either the isatuximab (n=154) or control group (n=153). Median follow-up at data cutoff (Oct 1, 2020) was 35·3 months (IQR 33·5-37·4). Median overall survival was 24·6 months (95% CI 20·3-31·3) in the isatuximab group and 17·7 months (14·4-26·2) in the control group (hazard ratio 0·76 [95% CI 0·57-1·01]; one-sided log-rank p=0·028, not crossing prespecified stopping boundary). The most common grade 3 or worse treatment-emergent adverse events in the isatuximab group versus the control group were neutropenia (76 [50%] of 152 patients vs 52 [35%] of 149 patients), pneumonia (35 [23%] vs 31 [21%]), and thrombocytopenia (20 [13%] vs 18 [12%]). Serious treatment-emergent adverse events were observed in 111 (73%) patients in the isatuximab group and 90 (60%) patients in the control group. Two (1%) treatment-related deaths occurred in the isatuximab group (one due to sepsis and one due to cerebellar infarction) and two (1%) occurred in the control group (one due to pneumonia and one due to urinary tract infection).
INTERPRETATION


Addition of isatuximab plus pomalidomide-dexamethasone resulted in a 6·9-month difference in median overall survival compared with pomalidomide-dexamethasone and is a new standard of care for lenalidomide-refractory and proteasome inhibitor-refractory or relapsed multiple myeloma. Final overall survival analysis follow-up is ongoing.
FUNDING


Sanofi.",2022,Median overall survival was 24·6 months (95% CI 20·3-31·3) in the isatuximab group and 17·7 months (14·4-26·2) in the control group (hazard ratio 0·76,"['Between Jan 10, 2017, and Feb 2, 2018, 387 patients were screened and 307 randomly assigned to either the isatuximab (n=154) or control group (n=153', 'Patients were excluded if they had anti-CD38 refractory disease or previously received', 'adult patients (aged ≥18 years) with relapsed and refractory multiple myeloma who had received at least two previous lines of therapy, including lenalidomide and a proteasome inhibitor, and had an Eastern Cooperative Oncology Group performance status of 0-2 were recruited from 102 hospitals in 24 countries across Europe, North America, and the Asia-Pacific regions', 'patients with relapsed and refractory multiple myeloma (ICARIA-MM']","['dexamethasone', 'Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone', 'pomalidomide-dexamethasone', 'isatuximab plus pomalidomide-dexamethasone', 'oral pomalidomide', 'intravenous isatuximab', 'pomalidomide', 'isatuximab-pomalidomide-dexamethasone (isatuximab group) or pomalidomide-dexamethasone (control group']","['pneumonia', 'deaths', 'Serious treatment-emergent adverse events', 'neutropenia', 'overall survival analysis', 'Safety', 'unacceptable toxicity, or withdrawal of consent', 'median overall survival', 'progression-free survival', 'thrombocytopenia', 'Median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4330502', 'cui_str': 'isatuximab'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0075742', 'cui_str': 'Lymphocyte antigen CD38'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C1443643', 'cui_str': 'Proteasome inhibitor'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4330502', 'cui_str': 'isatuximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",387.0,0.53365,Median overall survival was 24·6 months (95% CI 20·3-31·3) in the isatuximab group and 17·7 months (14·4-26·2) in the control group (hazard ratio 0·76,"[{'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA, USA. Electronic address: paul_richardson@dfci.harvard.edu.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Perrot', 'Affiliation': ""CHU de Toulouse, IUCT-O, Université de Toulouse, UPS, Service d'Hématologie, Toulouse, France.""}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clínica Universidad de Navarra, Navarra, CCUN, CIMA, IDISNA, CIBER-ONC, Pamplona, Spain.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Spicka', 'Affiliation': 'General Faculty Hospital, and First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Leleu', 'Affiliation': ""Service d'Hématologie et Thérapie Cellulaire, CHU and CIC Inserm 1402, Poitiers Cedex, France.""}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Schjesvold', 'Affiliation': 'Oslo Myeloma Center, Department of Haematology, Oslo University Hospital and KG Jebsen Center for B Cell Malignancies, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Hematology Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens School of Medicine, Athens, Greece.'}, {'ForeName': 'Jeffrey Shang-Yi', 'Initials': 'JS', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Minarik', 'Affiliation': 'Department of Hemato-Oncology, Faculty of Medicine and Dentistry, Palacky University and University Hospital Olomouc, Olomouc, Czech Republic.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia ""Seràgnoli"", Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'H Miles', 'Initials': 'HM', 'LastName': 'Prince', 'Affiliation': 'Immunology and Molecular Oncology, Epworth Healthcare, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Malinge', 'Affiliation': 'Sanofi R&D, Vitry, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Dubin', 'Affiliation': 'Sanofi R&D, Vitry, France.'}, {'ForeName': 'Helgi', 'Initials': 'H', 'LastName': 'van de Velde', 'Affiliation': 'Sanofi R&D, Vitry, France.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Anderson', 'Affiliation': 'Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(22)00019-5']
2033,35151410,"Efficacy and safety of balovaptan for socialisation and communication difficulties in autistic adults in North America and Europe: a phase 3, randomised, placebo-controlled trial.","BACKGROUND


There are no approved pharmacological therapies to support treatment of the core communication and socialisation difficulties associated with autism spectrum disorder in adults. We aimed to assess the efficacy, safety, and pharmacokinetics of balovaptan, a vasopressin 1a receptor antagonist, versus placebo in autistic adults.
METHODS


V1aduct was a phase 3, randomised, placebo-controlled, double-blind trial, conducted at 46 sites across six countries (the USA, the UK, France, Italy, Spain, and Canada). Eligible participants were aged 18 years or older with an intelligence quotient (IQ) of 70 or higher, and met the criteria for moderate-to-severe autism spectrum disorder (DSM-5 and Autism Diagnostic Observation Schedule). Participants were randomly allocated (1:1), with an independent interactive voice or web-based response system, to receive balovaptan (10 mg) or placebo daily for 24 weeks. Randomisation was stratified by an individual's baseline Vineland-II two-domain composite (2DC) score (<60 or ≥60), sex, region (North America or rest of world), and age (<25 years or ≥25 years). Participants, study site personnel, and the sponsor were masked to treatment assignment. The primary endpoint was change from baseline in Vineland-II 2DC score (the mean composite score across the Vineland-II socialisation and communication domains) at week 24. The primary analysis was done with ANCOVA in the intention-to-treat population. The V1aduct study was terminated for futility after around 50% of participants completed the week 24 visit. This trial is registered with ClinicalTrials.gov (NCT03504917).
FINDINGS


Between Aug 8, 2018, and July 1, 2020, 540 people were screened for eligibility, of whom 322 were allocated to receive balovaptan (164 [51%]) or placebo (158 [49%]). One participant from the balovaptan group was not treated before trial termination and was excluded from the analysis. 60 participants in the balovaptan group and 55 in the placebo group discontinued treatment before week 24. The sample consisted of 64 (20%) women and 257 (80%) men, with 260 (81%) participants from North America and 61 (19%) from Europe. At baseline, mean age was 27·6 years (SD 9·7) and mean IQ score was 104·8 (18·1). Two (1%) participants were American Indian or Alaska Native, eight (2%) were Asian, 15 (5%) were Black or African American, 283 (88%) were White, four (1%) were of multiple races, and nine (3%) were of unknown race. Mean baseline Vineland-II 2DC scores were 67·2 (SD 15·3) in the balovaptan group and 66·2 (17·7) in the placebo group. The interim futility analysis showed no improvement for balovaptan versus placebo in terms of Vineland-II 2DC score at week 24 compared with baseline, with a least-squares mean change of 2·91 (SE 1·52) in the balovaptan group (n=79) and 4·75 (1·60) in the placebo group (n=71; estimated treatment difference -1·84 [95% CI -5·15 to 1·48]). In the final analysis, mean change from baseline in Vineland-II 2DC score at week 24 was 4·56 (SD 10·85) in the balovaptan group (n=111) and 6·83 (12·18) in the placebo group (n=99). Balovaptan was well tolerated, with similar proportions of participants with at least one adverse event in the balovaptan group (98 [60%] of 163) and placebo group (104 [66%] of 158). The most common adverse events were nasopharyngitis (14 [9%] in the balovaptan group and 19 [12%] in the placebo group), diarrhoea (11 [7%] and 14 [9%]), upper respiratory tract infection (ten [6%] and nine [6%]), insomnia (five [3%] and eight [5%]), oropharyngeal pain (five [3%] and eight [5%]), and dizziness (two [1%] and ten [6%]). Serious adverse events were reported for two (1%) participants in the balovaptan group (one each of suicidal ideation and schizoaffective disorder), and five (3%) participants in the placebo group (one each of suicidal ideation, panic disorder, limb abscess, urosepsis, colitis [in the same participant with urosepsis], and death by suicide). No treatment-related deaths occurred.
INTERPRETATION


Balovaptan did not improve social communication in autistic adults. This study provides insights into challenges facing autism spectrum disorder trials, including the considerable placebo response and the selection of appropriate outcome measures.
FUNDING


F Hoffmann-La Roche.",2022,"The interim futility analysis showed no improvement for balovaptan versus placebo in terms of Vineland-II 2DC score at week 24 compared with baseline, with a least-squares mean change of 2·91 (SE 1·52) in the balovaptan group (n=79) and 4·75 (1·60) in the placebo group (n=71; estimated treatment difference -1·84","['46 sites across six countries (the USA, the UK, France, Italy, Spain, and Canada', 'autism spectrum disorder in adults', '540 people were screened for eligibility, of whom 322 were allocated to receive', 'sample consisted of 64 (20%) women and 257 (80%) men, with 260 (81%) participants from North America and 61 (19%) from Europe', 'Between Aug 8, 2018, and July 1, 2020', 'Eligible participants were aged 18 years or older with an intelligence quotient (IQ) of 70 or higher, and met the criteria for moderate-to-severe autism spectrum disorder (DSM-5 and Autism Diagnostic Observation Schedule', 'autistic adults in North America and Europe', 'Two (1%) participants were American Indian or Alaska Native, eight (2%) were Asian, 15 (5%) were Black or African American, 283 (88%) were White, four (1%) were of multiple races, and nine (3%) were of unknown race', '60 participants in the balovaptan group and 55 in the', 'autistic adults']","['placebo', 'Balovaptan', 'vasopressin 1a receptor antagonist, versus placebo', 'interactive voice or web-based response system, to receive balovaptan (10 mg) or placebo', 'balovaptan']","['Efficacy and safety', 'efficacy, safety, and pharmacokinetics of balovaptan', 'dizziness', 'tolerated', 'Serious adverse events', 'upper respiratory tract infection', 'suicidal ideation and schizoaffective disorder', 'suicidal ideation, panic disorder, limb abscess, urosepsis, colitis', 'Vineland-II 2DC score', 'insomnia', 'diarrhoea', 'oropharyngeal pain', 'social communication', 'Mean baseline Vineland-II 2DC scores', 'change from baseline in Vineland-II 2DC score']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C5192767', 'cui_str': '540'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1515945', 'cui_str': 'American Indian or Alaska native'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0149801', 'cui_str': 'Sepsis due to urinary tract infection'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2363731', 'cui_str': 'Oropharyngeal pain'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",540.0,0.814423,"The interim futility analysis showed no improvement for balovaptan versus placebo in terms of Vineland-II 2DC score at week 24 compared with baseline, with a least-squares mean change of 2·91 (SE 1·52) in the balovaptan group (n=79) and 4·75 (1·60) in the placebo group (n=71; estimated treatment difference -1·84","[{'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Jacob', 'Affiliation': 'Child and Adolescent Psychiatry, University of Minnesota, Minneapolis, MN, USA. Electronic address: sjacob@umn.edu.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Veenstra-VanderWeele', 'Affiliation': 'Columbia University and New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'Murphy', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McCracken', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'F Hoffmann-La Roche, Welwyn Garden City, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Sanders', 'Affiliation': 'F Hoffmann-La Roche, Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Meyenberg', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wiese', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Gurpreet', 'Initials': 'G', 'LastName': 'Deol-Bhullar', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wandel', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ashford', 'Affiliation': 'F Hoffmann-La Roche, Welwyn Garden City, UK.'}, {'ForeName': 'Evdokia', 'Initials': 'E', 'LastName': 'Anagnostou', 'Affiliation': 'Holland Bloorview Kids Rehabilitation Hospital, University of Toronto, Toronto, ON, Canada.'}]",The lancet. Psychiatry,['10.1016/S2215-0366(21)00429-6']
2034,35157055,Cost-effectiveness of Icosapent Ethyl for High-risk Patients With Hypertriglyceridemia Despite Statin Treatment.,"Importance


The Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial (REDUCE-IT) demonstrated the efficacy of icosapent ethyl (IPE) for high-risk patients with hypertriglyceridemia and known cardiovascular disease or diabetes and at least 1 other risk factor who were treated with statins.
Objective


To estimate the cost-effectiveness of IPE compared with standard care for high-risk patients with hypertriglyceridemia despite statin treatment.
Design, Setting, and Participants


An in-trial cost-effectiveness analysis was performed using patient-level study data from REDUCE-IT, and a lifetime analysis was performed using a microsimulation model and data from published literature. The study included 8179 patients with hypertriglyceridemia despite stable statin therapy recruited between November 21, 2011, and May 31, 2018. Analyses were performed from a US health care sector perspective. Statistical analysis was performed from March 1, 2018, to October 31, 2021.
Interventions


Patients were randomly assigned to IPE, 4 g/d, or placebo and were followed up for a median of 4.9 years (IQR, 3.5-5.3 years). The cost of IPE was $4.16 per day after rebates using SSR Health net cost (SSR cost) and $9.28 per day with wholesale acquisition cost (WAC).
Main Outcomes and Measures


Main outcomes were incremental quality-adjusted life-years (QALYs), total direct health care costs (2019 US dollars), and cost-effectiveness.
Results


A total of 4089 patients (2927 men [71.6%]; median age, 64.0 years [IQR, 57.0-69.0 years]) were randomly assigned to receive IPE, and 4090 patients (2895 men [70.8%]; median age, 64.0 years [IQR, 57.0-69.0 years]) were randomly assigned to receive standard care. Treatment with IPE yielded more QALYs than standard care both in trial (3.34 vs 3.27; mean difference, 0.07 [95% CI, 0.01-0.12]) and over a lifetime projection (10.59 vs 10.35; mean difference, 0.24 [95% CI, 0.15-0.33]). In-trial, total health care costs were higher with IPE using either SSR cost ($18 786) or WAC ($24 544) than with standard care ($17 273; mean difference from SSR cost, $1513 [95% CI, $155-$2870]; mean difference from WAC, $7271 [95% CI, $5911-$8630]). Icosapent ethyl cost $22 311 per QALY gained using SSR cost and $107 218 per QALY gained using WAC. Over a lifetime, IPE was projected to be cost saving when using SSR cost ($195 276) compared with standard care ($197 064; mean difference, -$1788 [95% CI, -$9735 to $6159]) but to have higher costs when using WAC ($202 830) compared with standard care (mean difference, $5766 [95% CI, $1094-$10 438]). Compared with standard care, IPE had a 58.4% lifetime probability of costing less and being more effective when using SSR cost and an 89.4% probability of costing less than $50 000 per QALY gained when using SSR cost and a 72.5% probability of costing less than $50 000 per QALY gained when using WAC.
Conclusions and Relevance


This study suggests that, both in-trial and over the lifetime, IPE offers better cardiovascular outcomes than standard care in REDUCE-IT participants at common willingness-to-pay thresholds.",2022,"Compared with standard care, IPE had a 58.4% lifetime probability of costing less and being more effective when using SSR cost and an 89.4% probability of costing less than $50 000 per QALY gained when using SSR cost and a 72.5% probability of costing less than $50 000 per QALY gained when using WAC.
","['high-risk patients with hypertriglyceridemia and known cardiovascular disease or diabetes and at least 1 other risk factor who were treated with statins', '4089 patients (2927 men [71.6%]; median age, 64.0 years [IQR, 57.0-69.0 years', '8179 patients with hypertriglyceridemia despite stable statin therapy recruited between November 21, 2011, and May 31, 2018', 'high-risk patients with hypertriglyceridemia despite statin treatment', 'High-risk Patients With Hypertriglyceridemia', ' and 4090 patients (2895 men [70.8%]; median age, 64.0 years [IQR, 57.0-69.0 years']","['IPE', 'icosapent ethyl (IPE', 'Icosapent Ethyl', 'placebo']","['Cost-effectiveness', 'Reduction of Cardiovascular Events', 'cost of IPE', 'Icosapent ethyl cost', 'incremental quality-adjusted life-years (QALYs), total direct health care costs (2019 US dollars), and cost-effectiveness', 'total health care costs']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",8179.0,0.349965,"Compared with standard care, IPE had a 58.4% lifetime probability of costing less and being more effective when using SSR cost and an 89.4% probability of costing less than $50 000 per QALY gained when using SSR cost and a 72.5% probability of costing less than $50 000 per QALY gained when using WAC.
","[{'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Weintraub', 'Affiliation': 'MedStar Healthcare Delivery Research Network, MedStar Health Research Institute, Washington, DC.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Zugui', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Institute for Research on Equity and Community Health, ChristianaCare Health System, Newark, Delaware.'}, {'ForeName': 'Sarahfaye', 'Initials': 'S', 'LastName': 'Dolman', 'Affiliation': 'MedStar Healthcare Delivery Research Network, MedStar Health Research Institute, Washington, DC.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': 'Department of Medicine, Cardiology Section, Veterans Affairs Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Bress', 'Affiliation': 'Department of Population Health Sciences, University of Utah, Salt Lake City.'}, {'ForeName': 'Jordan B', 'Initials': 'JB', 'LastName': 'King', 'Affiliation': 'Department of Population Health Sciences, University of Utah, Salt Lake City.'}, {'ForeName': 'Brandon K', 'Initials': 'BK', 'LastName': 'Bellows', 'Affiliation': 'Department of Medicine, Columbia University, New York, New York.'}, {'ForeName': 'Gabriel S', 'Initials': 'GS', 'LastName': 'Tajeu', 'Affiliation': 'Health Services Administration and Policy, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Catherine G', 'Initials': 'CG', 'LastName': 'Derington', 'Affiliation': 'Department of Population Health Sciences, University of Utah, Salt Lake City.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'Health Economics and Outcomes Research, Optum, Eden Prairie, Minnesota.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Andrade', 'Affiliation': 'Health Economics and Outcomes Research, Optum, Eden Prairie, Minnesota.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Medical School of Université de Paris, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Eliot A', 'Initials': 'EA', 'LastName': 'Brinton', 'Affiliation': 'Utah Lipid Center, Salt Lake City.'}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Jacobson', 'Affiliation': 'Office of Health Promotion and Disease Prevention, Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Ballantyne', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kolm', 'Affiliation': 'Center of Biostatistics, Informatics, and Data Science, MedStar Health Research Institute, Washington, DC.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.48172']
2035,35162794,Can Post-Exercise Hemodynamic Response Be Influenced by Different Recovery Methods in Paraplegic Sportsmen?,"Post-exercise hypotension is of great clinical relevance and also in sports training settings, as recovery speed is important. The aim of this study was to compare the influence of different recovery methods on post-exercise hemodynamic response. Twelve male paraplegic sportsmen (25.40 ± 3.30 years) performed a strength training (ST) session using the bench press exercise. After the ST, three recovery methods were randomly performed over a 15-min period: passive recovery (PR), cold-water (CW) and dry needle (DN). Blood pressure (BP), heart rate (HR) and myocardial oxygen were measured before and post ST, as well as post the recovery method. Results: Dry needling induced lower systolic blood pressure (SBP) immediately after the treatment when compared with the other recovery methods, but the contrary was observed at 50 and 60-min post recovery, where records with DN exhibit higher mean values (η 2 p = 0.330). There were no differences in post-exercise diastolic BP and mean BP between recovery methods. There was a significantly higher HR after the PR method, when compared with CW and with DN (η 2 p = 0.426). The same was observed for double product and for myocardial oxygen, though with a larger effect size (η 2 p = 0.446). We conclude that dry needling seems to induce a faster SBP lowering immediately after the procedure but at 50-min post procedure the cold-water method showed better result. As for HR, both procedures (DN and CW) showed a better recovery when compared with passive recovery, along the several moments of measurement.",2022,"Dry needling induced lower systolic blood pressure (SBP) immediately after the treatment when compared with the other recovery methods, but the contrary was observed at 50 and 60-min post recovery, where records with DN exhibit higher mean values (η 2 p = 0.330).",['Twelve male paraplegic sportsmen (25.40 ± 3.30 years'],"['passive recovery (PR), cold-water (CW) and dry needle (DN', 'strength training (ST) session using the bench press exercise']","['post-exercise diastolic BP and mean BP', 'Blood pressure (BP), heart rate (HR) and myocardial oxygen', 'lower systolic blood pressure (SBP', 'SBP lowering']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0857021', 'cui_str': 'Paraplegic'}, {'cui': 'C0349678', 'cui_str': 'Sportsman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0277885', 'cui_str': 'Decreased systolic arterial pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.04143,"Dry needling induced lower systolic blood pressure (SBP) immediately after the treatment when compared with the other recovery methods, but the contrary was observed at 50 and 60-min post recovery, where records with DN exhibit higher mean values (η 2 p = 0.330).","[{'ForeName': 'Felipe J', 'Initials': 'FJ', 'LastName': 'Aidar', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), São Cristovão 49100-000, Brazil.'}, {'ForeName': 'Edilson F', 'Initials': 'EF', 'LastName': 'Dantas', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), São Cristovão 49100-000, Brazil.'}, {'ForeName': 'Paulo F', 'Initials': 'PF', 'LastName': 'Almeida-Neto', 'Affiliation': 'Department of Physical Education, Health Sciences Center, Federal University of Rio Grande do Norte (UFRN), Natal 59078-970, Brazil.'}, {'ForeName': 'Frederico R', 'Initials': 'FR', 'LastName': 'Neto', 'Affiliation': 'Paralympic Sports Program, SARAH Rehabilitation Hospital Network, Brasilia 71535-005, Brazil.'}, {'ForeName': 'Nuno D', 'Initials': 'ND', 'LastName': 'Garrido', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), Trás os Montes and Alto Douro University, 5001-801 Vila Real, Portugal.'}, {'ForeName': 'Breno G', 'Initials': 'BG', 'LastName': 'Cabral', 'Affiliation': 'Department of Physical Education, Health Sciences Center, Federal University of Rio Grande do Norte (UFRN), Natal 59078-970, Brazil.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Figueiredo', 'Affiliation': 'Exercise Physiology Laboratory, Estacio de Sá University, Rio de Janeiro 22790-710, Brazil.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Reis', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), Trás os Montes and Alto Douro University, 5001-801 Vila Real, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph19031772']
2036,35162787,Acute Effects of Different Activity Types and Work-To-Rest Ratio on Post-Activation Performance Enhancement in Young Male and Female Taekwondo Athletes.,"The study assessed conditioning activities' (CAs') effects involving different work-to-rest ratios (WRR) on taekwondo athletes' physical performance. Adolescent taekwondo athletes (age: 16 ± 1 years) randomly participated in the control six experimental conditions. Each condition was composed of standard warm-up and CA composed of plyometrics (P) or repeated high-intensity techniques (RHIT) performed using three different WRR: 1:6, 1:7, self-selected rest time (SSRT). After rest, athletes performed countermovement jump (CMJ), taekwondo specific agility test (TSAT), 10 s frequency speed kick test (FSKT-10s), multiple frequency speed kick test (FSKT-mult). P1:7, SSRT induced techniques higher number in FSKT-10s ( p  < 0.001 for all comparisons) and lower TSAT time ( p  < 0.01 for all comparisons) compared with control. Kicks-number recorded during FSKT-mult was lower in the control compared with RHIT1:6 ( p  = 0.001), RHIT1:7 ( p  < 0.001), RHITSSRT ( p  < 0.05), P1:7 ( p  < 0.001), and SSRT ( p  < 0.001). Kicking decrement index (DI) during FSKT-mult was lower after RHIT1:6 compared with control ( p  = 0.008), RHIT1:7 ( p  = 0.031), P 1:6 ( p  = 0.014), PSSRT ( p  = 0.041). (1) P1:7 and PSSRT can be used to improve taekwondo-specific agility and kicks-number, (2) RHIT1:6 is beneficial to maintain low DI, and (3) plyometric and different WRR-repeated-techniques can enhance kicks-number.",2022,"Kicks-number recorded during FSKT-mult was lower in the control compared with RHIT1:6 ( p  = 0.001), RHIT1:7 ( p  < 0.001),","['Adolescent taekwondo athletes (age: 16 ± 1 years) randomly participated in the control six experimental conditions', 'Young Male and Female Taekwondo Athletes']",['Different Activity Types and Work-To-Rest Ratio'],"['countermovement jump (CMJ), taekwondo specific agility test (TSAT), 10 s frequency speed kick test (FSKT-10s), multiple frequency speed kick test (FSKT-mult', 'Kicking decrement index (DI) during FSKT-mult', 'Kicks-number recorded during FSKT-mult', ""conditioning activities' (CAs') effects involving different work-to-rest ratios (WRR"", 'lower TSAT time']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0429928', 'cui_str': 'Test time'}]",,0.0307561,"Kicks-number recorded during FSKT-mult was lower in the control compared with RHIT1:6 ( p  = 0.001), RHIT1:7 ( p  < 0.001),","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Ouergui', 'Affiliation': 'High Institute of Sport and Physical Education of Kef, University of Jendouba, El Kef 7100, Tunisia.'}, {'ForeName': 'Slaheddine', 'Initials': 'S', 'LastName': 'Delleli', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax 3000, Tunisia.""}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Messaoudi', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax 3000, Tunisia.""}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax 3000, Tunisia.""}, {'ForeName': 'Anissa', 'Initials': 'A', 'LastName': 'Bouassida', 'Affiliation': 'High Institute of Sport and Physical Education of Kef, University of Jendouba, El Kef 7100, Tunisia.'}, {'ForeName': 'Ezdine', 'Initials': 'E', 'LastName': 'Bouhlel', 'Affiliation': 'Laboratoire de Physiologie de l\'exercice et Physiopathologie, de L\'intégré au Moléculaire ""Biologie, Médecine, Santé"", UR12ES06, Faculty of Medicine Ibn El Jazzar, University of Sousse, Sousse 4000, Tunisia.'}, {'ForeName': 'Emerson', 'Initials': 'E', 'LastName': 'Franchini', 'Affiliation': 'Martial Arts and Combat Sports Research Group, School of Physical Education and Sport, University of São Paulo, 05508-030 São Paulo, Brazil.'}, {'ForeName': 'Luca Paolo', 'Initials': 'LP', 'LastName': 'Ardigò', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, School of Exercise and Sport Science, University of Verona, Via Felice Casorati 43, 37131 Verona, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph19031764']
2037,35162786,Study Protocol for a Randomized Controlled Trial Evaluating the Effectiveness of a Group-Based Self-Determination Enhancement Intervention for Adults with Mild Intellectual Disability and Their Caregivers.,"Self-determination is regarded as an adult outcome for people with an intellectual disability (ID). However, self-determination curricula are rarely available in Hong Kong. This paper outlines a protocol for an experimental study that examines the effectiveness of a group-based self-determination enhancement intervention for adults with mild ID and their caregivers. A randomized controlled trial with pre-test, post-test and three-month follow-up is proposed. A total of 120 participants will be randomly assigned to three conditions: self-determination enhancement group, self-determination enhancement PLUS group (with caregivers in a parallel group) and leisure activity group as a control condition. Five groups will be organized for each of the three conditions. There will be 10 sessions per group covering the core components of self-determination including self-knowledge, goal setting and attaining goals, self-regulating and adjusting plans. Components for caregivers include understanding how self-determination and REACH responding skills can support their children to exercise self-determination through positive interaction. Self-determination competencies and personal well-being will be measured at three points in time. The proposed study is the first evidence-based local study aimed at examining a culturally tailored self-determination enhancement intervention for people with ID and fills a research gap in existing interventions. If the intervention is demonstrated to be effective, it will provide new knowledge for a group-based intervention and will be used with Chinese-speaking people with ID in different parts of the world. (Trial registration: ClinicalTrials.gov: NCT05167929).",2022,This paper outlines a protocol for an experimental study that examines the effectiveness of a group-based self-determination enhancement intervention for adults with mild ID and their caregivers.,"['120 participants', 'people with ID', 'people with an intellectual disability (ID', 'adults with mild ID and their caregivers', 'Adults with Mild Intellectual Disability and Their Caregivers']","['group-based self-determination enhancement intervention', 'culturally tailored self-determination enhancement intervention', 'Group-Based Self-Determination Enhancement Intervention', 'self-determination enhancement group, self-determination enhancement PLUS group (with caregivers in a parallel group) and leisure activity group as a control condition']",[],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026106', 'cui_str': 'Mild intellectual disability'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],120.0,0.0609253,This paper outlines a protocol for an experimental study that examines the effectiveness of a group-based self-determination enhancement intervention for adults with mild ID and their caregivers.,"[{'ForeName': 'Phyllis King Shui', 'Initials': 'PKS', 'LastName': 'Wong', 'Affiliation': 'Department of Social Work, Chinese University of Hong Kong, Hong Kong, China.'}]",International journal of environmental research and public health,['10.3390/ijerph19031763']
2038,35162761,"'Physio-EndEA' Study: A Randomized, Parallel-Group Controlled Trial to Evaluate the Effect of a Supervised and Adapted Therapeutic Exercise Program to Improve Quality of Life in Symptomatic Women Diagnosed with Endometriosis.","AIM


The 'Physio-EndEA' study aims to explore the potential benefits of a therapeutic exercise program (focused on lumbopelvic stabilization and tolerance to exertion) on the health-related quality of life (HRQoL) of symptomatic endometriosis women.
DESIGN


The present study will use a parallel-group randomized controlled trial design.
METHODS


A total of 22 symptomatic endometriosis women will be randomized 1:1 to the Physio-EndEA or usual care groups. The 'Physio-EndEA' program will consist of a one-week lumbopelvic stabilization learning phase followed by an eight-week phase of stretching, aerobic and resistance exercises focused on the lumbopelvic area that will be sequentially instructed and supervised by a trained physiotherapist (with volume and intensity progression) and adapted daily to the potential of each participant. The primary outcome measure is HRQoL. The secondary outcome measures included clinician-reported outcomes (pressure pain thresholds, muscle thickness and strength, flexibility, body balance and cardiorespiratory fitness) and patient-reported outcomes (pain intensity, physical fitness, chronic fatigue, sexual function, gastrointestinal function and sleep quality).
DISCUSSION


Findings of this study will help to identify cost-effective non-pharmacological options (such as this exercise-based intervention) that may contribute to the improvement of HRQoL in symptomatic endometriosis women.",2022,A total of 22 symptomatic endometriosis women will be randomized 1:1 to the Physio-EndEA or usual care groups.,"['Symptomatic Women Diagnosed with Endometriosis', 'symptomatic endometriosis women', '22 symptomatic endometriosis women']","['Supervised and Adapted Therapeutic Exercise Program', 'therapeutic exercise program']","['Quality of Life', 'health-related quality of life (HRQoL', 'clinician-reported outcomes (pressure pain thresholds, muscle thickness and strength, flexibility, body balance and cardiorespiratory fitness) and patient-reported outcomes (pain intensity, physical fitness, chronic fatigue, sexual function, gastrointestinal function and sleep quality']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0518656', 'cui_str': 'Chronic fatigue'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",22.0,0.065272,A total of 22 symptomatic endometriosis women will be randomized 1:1 to the Physio-EndEA or usual care groups.,"[{'ForeName': 'María Del Mar', 'Initials': 'MDM', 'LastName': 'Salinas-Asensio', 'Affiliation': 'Department of Physiotherapy, University of Granada, E-18016 Granada, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Ocón-Hernández', 'Affiliation': 'Biohealth Research Institute in Granada (ibs.GRANADA), E-18012 Granada, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Mundo-López', 'Affiliation': 'Clinic Psychology Center Alarcón (CPCA), E-18004 Granada, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Fernández-Lao', 'Affiliation': 'Department of Physiotherapy, University of Granada, E-18016 Granada, Spain.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Peinado', 'Affiliation': 'Biohealth Research Institute in Granada (ibs.GRANADA), E-18012 Granada, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Padilla-Vinuesa', 'Affiliation': 'Biohealth Research Institute in Granada (ibs.GRANADA), E-18012 Granada, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Álvarez-Salvago', 'Affiliation': 'Department of Physiotherapy, European University of Valencia, E-46010 Valencia, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Postigo-Martín', 'Affiliation': 'Department of Physiotherapy, University of Granada, E-18016 Granada, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Lozano-Lozano', 'Affiliation': 'Department of Physiotherapy, University of Granada, E-18016 Granada, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Lara-Ramos', 'Affiliation': ""Gynaecology and Obstetrics Unit, 'Virgen de las Nieves' University Hospital, E-18012 Granada, Spain.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Arroyo-Morales', 'Affiliation': 'Department of Physiotherapy, University of Granada, E-18016 Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cantarero-Villanueva', 'Affiliation': 'Department of Physiotherapy, University of Granada, E-18016 Granada, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Artacho-Cordón', 'Affiliation': 'Biohealth Research Institute in Granada (ibs.GRANADA), E-18012 Granada, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph19031738']
2039,35168142,Efficacy and safety of adjunctive cenobamate: Post-hoc analysis of study C017 in patients grouped by mechanism of action of concomitant antiseizure medications.,"PURPOSE


To assess how efficacy and safety outcomes were affected when cenobamate was co-administered with antiseizure medications (ASMs) that use either sodium channel blocker (SCB) or non-sodium channel blocker (non-SCB) mechanisms of action (MoAs) in patients with uncontrolled focal seizures.
METHODS


An exploratory post-hoc analysis of a randomized, double-blind, placebo-controlled clinical study (YKP3089C017) was conducted. Baseline concomitant ASMs were grouped as either those that employed an SCB or non-SCB MoA. Efficacy was examined by cenobamate dose (100 mg, 200 mg, and 400 mg/day) and concomitant ASM group using responder rates (≥50%, ≥75%, ≥90% seizure reduction; 100% seizure reduction/seizure freedom) during the maintenance phase and median percentage seizure reduction during the double-blind period. Treatment-emergent adverse events (TEAEs) were examined in the double-blind period.
RESULTS


When co-administered with SCBs or non-SCBs, significantly higher percentages of patients achieved ≥50%, ≥75%, and ≥90% responder rates with cenobamate 200 mg/day and/or 400 mg/day versus placebo. Additionally, significantly higher percentages of patients achieved seizure freedom with cenobamate 400 mg/day versus placebo (SCB group, 17.5% versus 1.2%; non-SCB group, 40.0% versus 0.0%). Patients receiving 200 mg/day and 400 mg/day and concomitant SCBs and all patients taking cenobamate combined with non-SCB concomitant ASMs had significantly greater median percentage reductions in focal seizure frequency versus placebo. TEAEs were similar across groups; however, dizziness was more frequently reported in the SCB group.
CONCLUSION


Cenobamate is a highly effective new treatment option for patients with uncontrolled focal seizures when co-administered with SCB or non-SCB ASMs.",2022,"TEAEs were similar across groups; however, dizziness was more frequently reported in the SCB group.
","['patients grouped by mechanism of action of concomitant antiseizure medications', 'patients with uncontrolled focal seizures']","['placebo', 'placebo (SCB', 'adjunctive cenobamate', 'sodium channel blocker (SCB) or non-sodium channel blocker (non-SCB) mechanisms of action (MoAs']","['Efficacy and safety', 'seizure freedom', 'dizziness', 'focal seizure frequency', 'efficacy and safety outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0872271', 'cui_str': 'Sodium channel blocker'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.298717,"TEAEs were similar across groups; however, dizziness was more frequently reported in the SCB group.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Department of General Epileptology, Bethel Epilepsy Centre, Mara Hospital, Maraweg 21, 33617 Bielefeld, Germany. Electronic address: christian.brandt@mara.de.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Sánchez-Álvarez', 'Affiliation': 'Neurology Service, Epilepsy Unit, Hospital Vithas la Salud, Granada, Spain.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Steinhoff', 'Affiliation': 'Department for Adults, Kork Epilepsy Center, Landstrasse 1, 77694 Kehl-Kork, Germany; Clinic for Neurology and Neurophysiology, Breisacher Str. 64, 79106 Freiburg, Germany. Electronic address: bsteinhoff@epilepsiezentrum.de.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Milanov', 'Affiliation': 'Neurology Clinic, Medical University of Sofia, 15 Blvd. Acad. Ivan Evstr. Geshov, 1431 Sofia, Bulgaria.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Serratosa', 'Affiliation': 'Epilepsy Unit, Department of Neurology, IIS Fundación Jiménez Díaz, Avenida Reyes Católicos, 28040 Madrid, Spain. Electronic address: joseserratosa@me.com.'}]",Seizure,['10.1016/j.seizure.2022.02.003']
2040,35169841,Influence of Genetic Information on Neonatologists' Decisions: A Psychological Experiment.,"
BACKGROUND AND OBJECTIVES


Genetic testing is expanding among ill neonates, yet the influence of genetic results on medical decision-making is not clear. With this study, we sought to determine how different types of genetic information with uncertain implications for prognosis influence clinicians' decisions to recommend intensive versus palliative care.
METHODS


We conducted a national study of neonatologists using a split sample experimental design. The questionnaire contained 4 clinical vignettes. Participants were randomly assigned to see one of 2 versions that varied only regarding whether they included the following genetic findings: (1) a variant of uncertain significance; (2) a genetic diagnosis that affects neurodevelopment but not acute survival; (3) a genetic versus nongenetic etiology of equally severe pathology; (4) a pending genetic testing result. Physicians answered questions about recommendations they would make for the patient described in each vignette.
RESULTS


Vignette versions that included a variant of uncertain significance, a diagnosis foreshadowing neurodevelopmental impairment, or a genetic etiology of disease were all associated with an increased likelihood of recommending palliative rather than intensive care. A pending genetic test result did not have a significant effect on care recommendations.
CONCLUSIONS


Findings from this study of hypothetical cases suggest neonatologists apply uncertain genetic findings or those that herald neurodevelopmental disability in problematic ways. As genetic testing expands, understanding how it is used in decision-making and educating clinicians regarding appropriate use are paramount.",2022,"A pending genetic test result did not have a significant effect on care recommendations.
",['ill neonates'],[],[],"[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]",[],[],,0.058335,"A pending genetic test result did not have a significant effect on care recommendations.
","[{'ForeName': 'Katharine Press', 'Initials': 'KP', 'LastName': 'Callahan', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Flibotte', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Skraban', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Katherine Taylor', 'Initials': 'KT', 'LastName': 'Wild', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Joffe', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Munson', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Feudtner', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}]",Pediatrics,['10.1542/peds.2021-052130']
2041,35169655,Effects of an online self-help intervention on university students' mental health during COVID-19: A non-randomized controlled pilot study.,"The COVID-19 pandemic has had a major impact on university students, particulary on their mental health. However, little is yet known about how to prevent and/or reduce this impact. Prior to COVID-19, some studies have shown that online stress management programs were successful enough to improve students' mental health and stress adjustment strategies, suggesting that these interventions should be further developed during the pandemic. Our study explored the effects on mental health of an online program that targeted stress management and learning. A total of 347 university students were initially recruited to take part in a non-randomized controlled study. After dropout, our final sample consisted of 114 participants, divided into two groups: an intervention group (participants who took part in the program) and the control group (participants who did not participate in the program). The variables measured were: anxiety and depressive symptoms, academic burnout, learned helplessness, and coping strategies. Means comparisons between baseline (T0) and an assessment at 8 weeks (T1) revealed reductions in anxiety symptoms and learned helplessness in the intervention group, but not in the control group. Our pilot study reports promising effects of an online program on students' psychological state.",2022,"Means comparisons between baseline (T0) and an assessment at 8 weeks (T1) revealed reductions in anxiety symptoms and learned helplessness in the intervention group, but not in the control group.","[""students' psychological state"", 'A total of 347 university students were initially recruited to take part in a non-randomized controlled study', ""university students' mental health during COVID-19""]","['online program', 'online self-help intervention']","['anxiety symptoms and learned helplessness', 'anxiety and depressive symptoms, academic burnout, learned helplessness, and coping strategies']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0018897', 'cui_str': 'Learned Helplessness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",114.0,0.0117353,"Means comparisons between baseline (T0) and an assessment at 8 weeks (T1) revealed reductions in anxiety symptoms and learned helplessness in the intervention group, but not in the control group.","[{'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Charbonnier', 'Affiliation': 'UNIV. NIMES, APSY, F-30021, Nîmes Cedex, France.'}, {'ForeName': 'Bastien', 'Initials': 'B', 'LastName': 'Trémolière', 'Affiliation': 'UNIV. NIMES, APSY, F-30021, Nîmes Cedex, France.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Baussard', 'Affiliation': 'UNIV. NIMES, APSY, F-30021, Nîmes Cedex, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Goncalves', 'Affiliation': 'UNIV. NIMES, APSY, F-30021, Nîmes Cedex, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Lespiau', 'Affiliation': 'UNIV. NIMES, APSY, F-30021, Nîmes Cedex, France.'}, {'ForeName': 'Antony G', 'Initials': 'AG', 'LastName': 'Philippe', 'Affiliation': 'UNIV. NIMES, APSY, F-30021, Nîmes Cedex, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Le Vigouroux', 'Affiliation': 'UNIV. NIMES, APSY, F-30021, Nîmes Cedex, France.'}]",Computers in human behavior reports,['10.1016/j.chbr.2022.100175']
2042,35170401,Targeting versus Tailoring Educational Videos for Encouraging Deceased Organ Donor Registration in Black-Owned Barbershops.,"In the U.S., black men are at highest risk for requiring kidney transplants but are among those least likely to register for organ donation. Prior outreach used videos culturally targeted for Black communities, yet registration rates remain insufficient to meet demand. Therefore, we assessed whether generic versus videos culturally targeted or personally tailored based on prior organ donation beliefs differentially increase organ donor registration. In a randomized controlled trial, 1,353 participants in Black-owned barbershops viewed generic, targeted, or tailored videos about organ donation. Logistic regression models assessed the relative impact of videos on: 1) immediate organ donor registration, 2) taking brochures, and 3) change in organ donation willingness stage of change from baseline. Randomization yielded approximately equal groups related to demographics and baseline willingness and beliefs. Neither targeted nor tailored videos differentially affected registration compared with the generic video, but participants in targeted and tailored groups were more likely to take brochures. Targeted (OR = 1.74) and tailored (OR = 1.57) videos were associated with incremental increases in organ donation willingness stage of change compared to the generic video. Distributing culturally targeted and individually tailored videos increased organ donor willingness stage of change among Black men in Black-owned barbershops but was insufficient for encouraging registration.Abbreviations: CI - confidence interval; DMV - Department of Motor Vehicles; BOBs - Black-owned barbershops; ODBI - organ donation belief index; ODWS - organ donation willingness stage of change; OR - odds ratio.",2022,Distributing culturally targeted and individually tailored videos increased organ donor willingness stage of change among Black men in Black-owned barbershops but was insufficient for encouraging registration.,"['1,353 participants in Black-owned barbershops viewed generic, targeted, or tailored videos about organ donation']","['Tailoring Educational Videos', 'generic versus videos culturally targeted or personally tailored based on prior organ donation beliefs differentially increase organ donor registration', 'Distributing culturally targeted and individually tailored videos']","['relative impact of videos on: 1) immediate organ donor registration, 2) taking brochures, and 3) change in organ donation willingness stage', 'organ donation willingness stage of change']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0029206', 'cui_str': 'Organ donor'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0029206', 'cui_str': 'Organ donor'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",1353.0,0.203544,Distributing culturally targeted and individually tailored videos increased organ donor willingness stage of change among Black men in Black-owned barbershops but was insufficient for encouraging registration.,"[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Wall', 'Affiliation': 'Ronald O. Perelman Department of Emergency Medicine, NYU Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Castillo', 'Affiliation': 'Ronald O. Perelman Department of Emergency Medicine, NYU Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Shuchat-Shaw', 'Affiliation': 'Department of Administration, Leadership, and Technology, NYU Steinhardt School of Culture, Education, and Human Development, New York, New York, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Norman', 'Affiliation': 'Department of Applied Statistics, Social Science, and Humanities, NYU Steinhardt School of Culture, Education, and Human Development, New York, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Ronald O. Perelman Department of Emergency Medicine, NYU Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Martinez-López', 'Affiliation': 'Ronald O. Perelman Department of Emergency Medicine, NYU Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Mairyn', 'Initials': 'M', 'LastName': 'López-Ríos', 'Affiliation': 'Ronald O. Perelman Department of Emergency Medicine, NYU Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Azizi A', 'Initials': 'AA', 'LastName': 'Seixas', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Jan L', 'Initials': 'JL', 'LastName': 'Plass', 'Affiliation': 'Department of Administration, Leadership, and Technology, NYU Steinhardt School of Culture, Education, and Human Development, New York, New York, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Ravenell', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, New York, USA.'}]",Journal of health communication,['10.1080/10810730.2022.2035021']
2043,35170751,Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer.,"BACKGROUND


Ovarian cancer is the sixth most common cancer in women world-wide. Epithelial ovarian cancer (EOC) is the most common; three-quarters of women present when disease has spread outside the pelvis (stage III or IV). Treatment consists of a combination of  surgery and platinum-based chemotherapy. Although initial responses to chemotherapy are good, most women with advanced disease will relapse. PARP (poly (ADP-ribose) polymerase) inhibitors (PARPi), are a type of anticancer treatment that works by preventing cancer cells from repairing DNA damage, especially in those with breast cancer susceptibility gene (BRCA) variants. PARPi offer a different mechanism of anticancer treatment from conventional chemotherapy.
OBJECTIVES


To determine the benefits and risks of poly (ADP-ribose) polymerase) inhibitors (PARPi) for the treatment of epithelial ovarian cancer (EOC).
SEARCH METHODS


We identified randomised controlled trials (RCTs) by searching the Cochrane Central Register of Controlled Trials (Central 2020, Issue 10), Cochrane Gynaecological Cancer Group Trial Register, MEDLINE (1990 to October 2020), Embase (1990 to October 2020), ongoing trials on www.controlled-trials.com/rct, www.clinicaltrials.gov, www.cancer.gov/clinicaltrials, the National Research Register (NRR), FDA database and pharmaceutical industry biomedical literature.
SELECTION CRITERIA


We included trials that randomised women with EOC to PARPi with no treatment, or PARPi versus conventional chemotherapy, or PARPi together with conventional chemotherapy versus conventional chemotherapy alone.
DATA COLLECTION AND ANALYSIS


We used standard Cochrane methodology. Two review authors independently assessed whether studies met the inclusion criteria. We contacted investigators for additional data. Outcomes included overall survival (OS), objective response rate (ORR), quality of life (QoL) and rate of adverse events.
MAIN RESULTS


We included 15 studies (6109 participants); four (3070 participants) with newly-diagnosed, advanced EOC and 11 (3039 participants) with recurrent EOC. The studies varied in types of comparisons and evaluated PARPi. Eight studies were judged as at low risk of bias in most of the domains. Quality of life data were generally poorly reported. Below we present six key comparisons.  The majority of participants had BRCA mutations, either in their tumour (sBRCAmut) and/or germline (gBRCAmut), or homologous recombination deficiencies (HRD) in their tumours. Newly diagnosed EOC Overall, four studies evaluated the effect of PARPi in newly-diagnosed, advanced EOC. Two compared PARPi with chemotherapy and chemotherapy alone. OS data were not reported. The combination of PARPi with chemotherapy may have little to no difference in progression-free survival (PFS) (two studies, 1564 participants; hazard ratio (HR) 0.82, 95% confidence interval (CI 0).49 to 1.38; very low-certainty evidence)(no evidence of disease progression at 12 months' 63% with PARPi versus 69% for placebo).  PARPi with chemotherapy likely increases any severe adverse event (SevAE) (grade 3 or higher) slightly (45%) compared with chemotherapy alone (51%) (two studies, 1549 participants, risk ratio (RR) 1.13, 95% CI 1.07 to 1.20; high-certainty evidence). PARPi combined with chemotherapy compared with chemotherapy alone likely results in little to no difference in the QoL (one study; 744 participants, MD 1.56 95% CI -0.42 to 3.54; moderate-certainty evidence).  Two studies compared PARPi monotherapy with placebo as maintenance after first-line chemotherapy in newly diagnosed EOC. PARPi probably results in little to no difference in OS (two studies, 1124 participants; HR 0.81, 95%CI 0.59 to 1.13; moderate-certainty evidence) (alive at 12 months 68% with PARPi versus 62% for placebo). However, PARPi may increase PFS (two studies, 1124 participants; HR 0.42, 95% CI 0.19 to 0.92; low-certainty evidence) (no evidence of disease progression at 12 months' 55% with PARPi versus 24% for placebo). There may be an increase in the risk of experiencing any SevAE (grade 3 or higher) with PARPi (54%) compared with placebo (19%)(two studies, 1118 participants, RR 2.87, 95% CI 1.65 to 4.99; very low-certainty evidence), but the evidence is very uncertain. There is probably a slight reduction in QoL with PARPi, although this may not be clinically significant (one study, 362 participants; MD -3.00, 95%CI -4.48 to -1.52; moderate-certainty evidence).  Recurrent, platinum-sensitive EOC Overall, 10 studies evaluated the effect of PARPi in recurrent platinum-sensitive EOC. Three studies compared PARPi monotherapy with chemotherapy alone. PARPi may result in little to no difference in OS (two studies, 331 participants; HR 0.95, 95%CI 0.62 to 1.47; low-certainty evidence) (percentage alive at 36 months 18% with PARPi versus 17% for placebo). Evidence is very uncertain about the effect of PARPi on PFS (three studies, 739 participants; HR 0.88, 95%CI 0.56 to 1.38; very low-certainty evidence)(no evidence of disease progression at 12 months 26% with PARPi versus 22% for placebo). There may be little to no difference in rates of any SevAE (grade 3 or higher) with PARPi (50%) than chemotherapy alone (47%) (one study, 254 participants; RR 1.06, 95%CI 0.80 to 1.39; low-certainty evidence). Four studies compared PARPi monotherapy as maintenance with placebo. PARPi may result in little to no difference in OS (two studies, 560 participants; HR 0.88, 95%CI 0.65 to 1.20; moderate-certainty evidence)(percentage alive at 36 months 21% with PARPi versus 17% for placebo). However, evidence suggests that PARPi as maintenance therapy results in a large PFS (four studies, 1677 participants; HR 0.34, 95% CI 0.28 to 0.42; high-certainty evidence)(no evidence of disease progression at 12 months 37% with PARPi versus 5.5% for placebo). PARPi maintenance therapy may result in a large increase in any SevAE (51%) (grade 3 or higher) than placebo (19%)(four studies, 1665 participants, RR 2.62, 95%CI 1.85 to 3.72; low-certainty evidence). PARPi compared with chemotherapy may result in little or no change in QoL (one study, 229 participants, MD 1.20, 95%CI -1.75 to 4.16; low-certainty evidence). Recurrent, platinum-resistant EOC Two studies compared PARPi with chemotherapy. The certainty of evidence in both studies was graded as very low. Overall, there was minimal information on the QoL and adverse events.
AUTHORS' CONCLUSIONS


PARPi maintenance treatment after chemotherapy may improve PFS in women with newly-diagnosed and recurrent platinum-sensitive EOC; there may be little to no effect on OS, although OS data are immature. Overall, this is likely at the expense of an increase in SevAE. It is  disappointing that data on quality of life outcomes  are relatively sparse. More research is needed to determine whether PARPi have a role to play in platinum-resistant disease.",2022,"However, PARPi may increase PFS (two studies, 1124 participants; HR 0.42, 95% CI 0.19 to 0.92; low-certainty evidence) (no evidence of disease progression at 12 months' 55% with PARPi versus 24% for placebo).","['1990 to October 2020), Embase (1990 to October 2020), ongoing trials on www.controlled-trials.com/rct, www.clinicaltrials.gov, www.cancer.gov/clinicaltrials, the National Research Register (NRR), FDA database and pharmaceutical industry biomedical literature', 'women with EOC to PARPi with no treatment, or', 'epithelial ovarian cancer (EOC', 'women with newly-diagnosed and recurrent platinum-sensitive EOC', '362 participants; MD -3.00, 95%CI -4.48 to -1.52; moderate-certainty evidence', 'ovarian cancer', '15 studies (6109 participants); four (3070 participants) with newly-diagnosed, advanced EOC and 11 (3039 participants) with recurrent EOC']","['chemotherapy', 'placebo', 'Poly(ADP-ribose) polymerase (PARP) inhibitors', 'poly (ADP-ribose) polymerase) inhibitors (PARPi', 'PARPi versus conventional chemotherapy, or PARPi together with conventional chemotherapy versus conventional chemotherapy alone', 'PARPi combined with chemotherapy', 'PARPi with chemotherapy', 'PARPi maintenance therapy', 'PARP (poly (ADP-ribose) polymerase) inhibitors (PARPi', 'PARPi monotherapy', 'combination of \xa0surgery and platinum-based chemotherapy', 'PARPi', 'PARPi monotherapy with placebo']","['progression-free survival (PFS', 'Epithelial ovarian cancer (EOC', 'OS', 'disease progression', 'risk of experiencing any SevAE', 'QoL', 'PFS', 'rates of any SevAE', 'severe adverse event (SevAE', 'Quality of life data', 'QoL and adverse events', 'overall survival (OS), objective response rate (ORR), quality of life (QoL) and rate of adverse events']","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0013185', 'cui_str': 'Industry, Drug'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C1567710', 'cui_str': 'PARP1 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",362.0,0.744523,"However, PARPi may increase PFS (two studies, 1124 participants; HR 0.42, 95% CI 0.19 to 0.92; low-certainty evidence) (no evidence of disease progression at 12 months' 55% with PARPi versus 24% for placebo).","[{'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Tattersall', 'Affiliation': 'Kingston Hospital NHS Foundation Trust, Kingston upon Thames, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ryan', 'Affiliation': ""The Academic Women's Health Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.""}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Wiggans', 'Affiliation': 'Department of Gynaecological Oncology, Cheltenham General Hospital, Glocestershire Hospitals NHS Foundation Trust, Cheltenham, UK.'}, {'ForeName': 'Ewelina', 'Initials': 'E', 'LastName': 'Rogozińska', 'Affiliation': 'The Evidence-Based Medicine Consultancy Ltd, Bath, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'Department of Gynaecological Oncology, GRACE Centre, Musgrove Park Hospital, Somerset NHS Foundation Trust, Taunton, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD007929.pub4']
2044,35172184,A novel application of an adaptive filter to dissociate the effects of TMS on neural excitability and trial-to-trial latency jitter in event-related potentials.,,2022,,[],['TMS'],[],[],"[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",[],,0.0681792,,"[{'ForeName': 'Mei-Heng', 'Initials': 'MH', 'LastName': 'Lin', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University, Newark, NJ, United States. Electronic address: meiheng.lin@rutgers.edu.'}, {'ForeName': 'Travis E', 'Initials': 'TE', 'LastName': 'Baker', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University, Newark, NJ, United States. Electronic address: travis.e.baker@rutgers.edu.'}]",Brain stimulation,['10.1016/j.brs.2022.02.002']
2045,35172082,Development and effectiveness of an educational program on developmental positioning for neonatal intensive care unit nurses in South Korea: a quasi-experimental study.,"PURPOSE


This study aimed to develop and evaluate the effectiveness of an educational program on developmental positioning (EPDP) for nurses in neonatal intensive care units (NICUs).
METHODS


The study utilized a non-equivalent control group pretestposttest design. Sixty NICU nurses were recruited from two university hospitals in Daejeon, South Korea. The EPDP consisted of a 7-week program: 3 weeks of education and practice, followed by 4 weeks of encouragement messages using social networking services. Developmental positioning (DP) posters and DP aids were also provided during the intervention period. The intervention group (n=30) received the EPDP, but not the control group. The data were analyzed using the x2 test, the Fisher exact test, the independent t-test, and repeated-measures analysis of variance.
RESULTS


Participants' knowledge (t=7.49, p<.001), attitudes (t=1.99, p=.001), self-efficacy (t=2.99, p=.004), performance of DP (t=2.98, p=.004) and Infant Positioning Assessment Tool (IPAT) scores (F=29.50, p<.001) were significantly higher in the intervention group than in the control group.
CONCLUSION


The EPDP can be an effective and useful program for improving the performance of DP among NICU nurses by increasing their knowledge, attitudes, and self-efficacy of DP. However, further research involving various NICU settings is needed to gather more empirical evidence.",2022,"RESULTS


Participants' knowledge (t=7.49, p<.001), attitudes (t=1.99, p=.001), self-efficacy (t=2.99, p=.004), performance of DP (t=2.98, p=.004) and Infant Positioning Assessment Tool (IPAT) scores (F=29.50, p<.001) were significantly higher in the intervention group than in the control group.
","['neonatal intensive care unit nurses in South Korea', 'Sixty NICU nurses were recruited from two university hospitals in Daejeon, South Korea', 'nurses in neonatal intensive care units (NICUs']","['educational program', 'educational program on developmental positioning (EPDP', 'EPDP', 'Developmental positioning']","['self-efficacy', 'Infant Positioning Assessment Tool (IPAT) scores', 'performance of DP']","[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}]",60.0,0.0192484,"RESULTS


Participants' knowledge (t=7.49, p<.001), attitudes (t=1.99, p=.001), self-efficacy (t=2.99, p=.004), performance of DP (t=2.98, p=.004) and Infant Positioning Assessment Tool (IPAT) scores (F=29.50, p<.001) were significantly higher in the intervention group than in the control group.
","[{'ForeName': 'Eun-Ju', 'Initials': 'EJ', 'LastName': 'Yun', 'Affiliation': 'Lecturer, Department of Nursing, Daejeon University, Daejeon, Korea.'}, {'ForeName': 'Tae-Im', 'Initials': 'TI', 'LastName': 'Kim', 'Affiliation': 'Professor, Department of Nursing, Daejeon University, Daejeon, Korea.'}]",Child health nursing research,['10.4094/chnr.2022.28.1.70']
2046,35172056,"EDP-938, a Respiratory Syncytial Virus Inhibitor, in a Human Virus Challenge.","BACKGROUND


Respiratory syncytial virus (RSV) infection causes substantial morbidity and mortality among infants, older adults, and immunocompromised adults. EDP-938, a nonfusion replication inhibitor of RSV, acts by modulating the viral nucleoprotein.
METHODS


In a two-part, phase 2a, randomized, double-blind, placebo-controlled challenge trial, we assigned participants who had been inoculated with RSV-A Memphis 37b to receive EDP-938 or placebo. Different doses of EDP-938 were assessed. Nasal-wash samples were obtained from day 2 until day 12 for assessments. Clinical symptoms were assessed by the participants, and pharmacokinetic profiles were obtained. The primary end point was the area under the curve (AUC) for the RSV viral load, as measured by reverse-transcriptase-quantitative polymerase-chain-reaction assay. The key secondary end point was the AUC for the total symptom score.
RESULTS


In part 1 of the trial, 115 participants were assigned to receive EDP-938 (600 mg once daily [600-mg once-daily group] or 300 mg twice daily after a 500-mg loading dose [300-mg twice-daily group]) or placebo. In part 2, a total of 63 participants were assigned to receive EDP-938 (300 mg once daily after a 600-mg loading dose [300-mg once-daily group] or 200 mg twice daily after a 400-mg loading dose [200-mg twice-daily group]) or placebo. In part 1, the AUC for the mean viral load (hours × log 10  copies per milliliter) was 204.0 in the 600-mg once-daily group, 217.7 in the 300-mg twice-daily group, and 790.2 in the placebo group. The AUC for the mean total symptom score (hours × score, with higher values indicating greater severity) was 124.5 in the 600-mg once-daily group, 181.8 in the 300-mg twice-daily group, and 478.8 in the placebo group. The results in part 2 followed a pattern similar to that in part 1: the AUC for the mean viral load was 173.9 in the 300-mg once-daily group, 196.2 in the 200-mg twice-daily group, and 879.0 in the placebo group, and the AUC for the mean total symptom score was 99.3, 89.6, and 432.2, respectively. In both parts, mucus production was more than 70% lower in each EDP-938 group than in the placebo group. The four EDP-938 regimens had a safety profile similar to that of placebo. Across all dosing regimens, the EDP-938 median time to maximum concentration ranged from 4 to 5 hours, and the geometric mean half-life ranged from 13.7 to 14.5 hours.
CONCLUSIONS


All EDP-938 regimens were superior to placebo with regard to lowering of the viral load, total symptom scores, and mucus weight without apparent safety concerns. (ClinicalTrials.gov number, NCT03691623.).",2022,"CONCLUSIONS


All EDP-938 regimens were superior to placebo with regard to lowering of the viral load, total symptom scores, and mucus weight without apparent safety concerns.","['participants who had been inoculated with RSV-A Memphis 37b to receive', 'infants, older adults, and immunocompromised adults', '115 participants', 'In part 2, a total of 63 participants']","['placebo', 'EDP-938 (300 mg once daily after a 600-mg loading dose [300-mg once-daily group] or 200 mg twice daily after a 400-mg loading dose [200-mg twice-daily group]) or placebo', 'EDP-938 or placebo', 'EDP-938 (600 mg once daily [600-mg once-daily group] or 300 mg twice daily after a 500-mg loading dose [300-mg twice-daily group]) or placebo', 'EDP-938']","['area under the curve (AUC) for the RSV viral load, as measured by reverse-transcriptase-quantitative polymerase-chain-reaction assay', 'mean total symptom score', 'mean viral load', 'total symptom score', 'mucus production', 'viral load, total symptom scores, and mucus weight', 'EDP-938 median time to maximum concentration']","[{'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035379', 'cui_str': 'RNA-directed DNA polymerase'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",115.0,0.718443,"CONCLUSIONS


All EDP-938 regimens were superior to placebo with regard to lowering of the viral load, total symptom scores, and mucus weight without apparent safety concerns.","[{'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Ahmad', 'Affiliation': 'From Enanta Pharmaceuticals, Watertown, MA (A.A., N.A.); hVIVO, London (K.E., N.N., J.M.), Boyd Consultants, Crew (B.M.), BJM Pharma, St. Neots (B.M.), and S-Cubed Biometrics, Abingdon (M.B., L.G.) - all in the United Kingdom; and Linical, Frankfurt, Germany (V.H.).'}, {'ForeName': 'Kingsley', 'Initials': 'K', 'LastName': 'Eze', 'Affiliation': 'From Enanta Pharmaceuticals, Watertown, MA (A.A., N.A.); hVIVO, London (K.E., N.N., J.M.), Boyd Consultants, Crew (B.M.), BJM Pharma, St. Neots (B.M.), and S-Cubed Biometrics, Abingdon (M.B., L.G.) - all in the United Kingdom; and Linical, Frankfurt, Germany (V.H.).'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Noulin', 'Affiliation': 'From Enanta Pharmaceuticals, Watertown, MA (A.A., N.A.); hVIVO, London (K.E., N.N., J.M.), Boyd Consultants, Crew (B.M.), BJM Pharma, St. Neots (B.M.), and S-Cubed Biometrics, Abingdon (M.B., L.G.) - all in the United Kingdom; and Linical, Frankfurt, Germany (V.H.).'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Horvathova', 'Affiliation': 'From Enanta Pharmaceuticals, Watertown, MA (A.A., N.A.); hVIVO, London (K.E., N.N., J.M.), Boyd Consultants, Crew (B.M.), BJM Pharma, St. Neots (B.M.), and S-Cubed Biometrics, Abingdon (M.B., L.G.) - all in the United Kingdom; and Linical, Frankfurt, Germany (V.H.).'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Murray', 'Affiliation': 'From Enanta Pharmaceuticals, Watertown, MA (A.A., N.A.); hVIVO, London (K.E., N.N., J.M.), Boyd Consultants, Crew (B.M.), BJM Pharma, St. Neots (B.M.), and S-Cubed Biometrics, Abingdon (M.B., L.G.) - all in the United Kingdom; and Linical, Frankfurt, Germany (V.H.).'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Baillet', 'Affiliation': 'From Enanta Pharmaceuticals, Watertown, MA (A.A., N.A.); hVIVO, London (K.E., N.N., J.M.), Boyd Consultants, Crew (B.M.), BJM Pharma, St. Neots (B.M.), and S-Cubed Biometrics, Abingdon (M.B., L.G.) - all in the United Kingdom; and Linical, Frankfurt, Germany (V.H.).'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Grey', 'Affiliation': 'From Enanta Pharmaceuticals, Watertown, MA (A.A., N.A.); hVIVO, London (K.E., N.N., J.M.), Boyd Consultants, Crew (B.M.), BJM Pharma, St. Neots (B.M.), and S-Cubed Biometrics, Abingdon (M.B., L.G.) - all in the United Kingdom; and Linical, Frankfurt, Germany (V.H.).'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mori', 'Affiliation': 'From Enanta Pharmaceuticals, Watertown, MA (A.A., N.A.); hVIVO, London (K.E., N.N., J.M.), Boyd Consultants, Crew (B.M.), BJM Pharma, St. Neots (B.M.), and S-Cubed Biometrics, Abingdon (M.B., L.G.) - all in the United Kingdom; and Linical, Frankfurt, Germany (V.H.).'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Adda', 'Affiliation': 'From Enanta Pharmaceuticals, Watertown, MA (A.A., N.A.); hVIVO, London (K.E., N.N., J.M.), Boyd Consultants, Crew (B.M.), BJM Pharma, St. Neots (B.M.), and S-Cubed Biometrics, Abingdon (M.B., L.G.) - all in the United Kingdom; and Linical, Frankfurt, Germany (V.H.).'}]",The New England journal of medicine,['10.1056/NEJMoa2108903']
2047,35172248,Time for a paradigm shift: The adolescent brain in addiction treatment.,"OBJECTIVE


One route to improve adolescent addiction treatment outcomes is to use translational approaches to help identify developmental neuroscience mechanisms that undergird active treatment ingredients and advance adolescent behavior change.
METHODS


This sample included 163 adolescents (ages 15-19) randomized to motivational interviewing (MI) vs. brief adolescent mindfulness (BAM). Youth completed an fMRI paradigm assessing adolescent brain response to therapist language (complex reflection vs. mindful; complex reflection vs. confront; mindful vs. confront) at pre- (prior to the completion of the full intervention) and post-treatment (at 3-month follow-up) and behavioral measures at 3, 6 and 12 months.
RESULTS


Youth in both treatment groups showed significant problem drinking reductions at 3 and 6 months, but MI youth demonstrated significantly better treatment outcomes than BAM youth at 12 months. We observed several significant treatment group differences (MI > BAM) in neural response to therapist language, including at pre-treatment when examining complex reflection vs. mindful, and complex reflection vs. confront (e.g., superior temporal gyrus, lingual gyrus); and at post-treatment when examining mindful vs. confront (e.g., supplementary motor area; middle frontal gyrus). When collapsed across treatment groups (MI + BAM), we observed significant differences by time, with youth showing a pattern of brain change in response to complex reflection vs. mindful, and complex reflection vs. confront (e.g., precuneus; postcentral gyrus). There was no evidence of a significant group × time interaction. However, brain change in response to therapist language (complex reflection vs. confront) in regions such as middle frontal gyrus, was associated with reductions in problem drinking at 12 months. Yet, few treatment group differences were observed.
CONCLUSIONS


These data underscore the need to better understand therapist language and it's impact on the developing brain, in order to inform and aggregate the most impactful elements of addiction treatment for future treatment development for adolescents.",2022,"RESULTS


Youth in both treatment groups showed significant problem drinking reductions at 3 and 6 months, but MI youth demonstrated significantly better treatment outcomes than BAM youth at 12 months.",['163 adolescents (ages 15-19) randomized to'],"['fMRI paradigm', 'motivational interviewing (MI) vs. brief adolescent mindfulness (BAM']",['problem drinking reductions'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",163.0,0.062981,"RESULTS


Youth in both treatment groups showed significant problem drinking reductions at 3 and 6 months, but MI youth demonstrated significantly better treatment outcomes than BAM youth at 12 months.","[{'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Mackiewicz Seghete', 'Affiliation': 'Oregon Health & Science University, Department of Psychiatry, 3181 SW Sam Jackson Park Rd, M/C UHN80R1, Portland, OR 97239, USA. Electronic address: mackiewi@ohsu.edu.'}, {'ForeName': 'Francesca M', 'Initials': 'FM', 'LastName': 'Filbey', 'Affiliation': 'Center for BrainHealth, School of Behavioral and Brain Sciences, The University of Texas at Dallas, 2200 West Mockingbird Lane, Dallas, TX 75235, USA. Electronic address: Francesca.filbey@utdallas.edu.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Hudson', 'Affiliation': 'Departments of Psychology and Interdisciplinary Neuroscience, University of Rhode Island, 130 Flagg Rd, Kingston, RI 02881 USA. Electronic address: feldsteinewing@uri.edu.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Hyun', 'Affiliation': 'Departments of Psychology and Interdisciplinary Neuroscience, University of Rhode Island, 130 Flagg Rd, Kingston, RI 02881 USA. Electronic address: hudsonk@uri.edu.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Feldstein Ewing', 'Affiliation': 'Departments of Psychology and Interdisciplinary Neuroscience, University of Rhode Island, 130 Flagg Rd, Kingston, RI 02881 USA. Electronic address: feldsteinewing@uri.edu.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2022.102960']
2048,35151058,The safety and efficacy of a low dose of tirofiban for early complications during and after stent-assisted coiling of ruptured intracranial aneurysms: A propensity matching study.,"PURPOSE


During stent-assisted coiling of ruptured intracranial aneurysms (RIA), appropriate antiplatelet administration is an important element of management. We aimed to evaluate the safety and efficacy of intravenous tirofiban administration versus dual antiplatelet therapy (DAPT) for stent-assisted coiling of RIAs within 24 h after procedure.
METHODS


From January 2015 to March 2019, two groups of patients with RIAs treated with stent-coiling were compared: the DAPT group (a loading dose of 300 mg clopidogrel and 300 mg aspirin) and the tirofiban group (intravenous administration of tirofiban 5 µg/kg over 1 min, followed by a maintenance dose of 0.1 µg/kg/min). The main outcome measures were rates of ischemic events and intracranial hemorrhage. Propensity score-matching (PSM) analysis was performed to correct imbalances in patient characteristics between the two groups.
RESULTS


A total of 200 patients with RIAs were identified, with 36 patients in DAPT group and 164 in tirofiban group. After PSM, 36 patients in DAPT group and 72 patients in tirofiban group were matched. Ischemic events were noted for 8.33% (3/36) of patients in DAPT group, and 4.17% (3/72) in tirofiban group within 24 h after procedure(P = 0.398). Intracranial hemorrhage was noted for 0.00% (0/36) of patients in DAPT group, and 1.39% (1/72) in tirofiban group (P = 1.000) within 24 h. And no significant difference in the rate of ischemic or hemorrhagic events after 24 h was detected.
CONCLUSIONS


Intravenous administration of a low dose of tirofiban may represent a safe and effective alternative to DAPT during stent-assisted coiling of RIAs.",2022,"Ischemic events were noted for 8.33% (3/36) of patients in DAPT group, and 4.17% (3/72) in tirofiban group within 24 h after procedure(P = 0.398).","['stent-assisted coiling of RIAs within 24\xa0h after procedure', 'ruptured intracranial aneurysms (RIA', 'ruptured intracranial aneurysms', '200 patients with RIAs were identified, with 36 patients in DAPT group and 164 in tirofiban group']","['DAPT', 'clopidogrel and 300\xa0mg aspirin', 'tirofiban', 'dual antiplatelet therapy (DAPT', 'tirofiban group (intravenous administration of tirofiban']","['rate of ischemic or hemorrhagic events', 'rates of ischemic events and intracranial hemorrhage', 'Intracranial hemorrhage', 'safe and effective alternative to DAPT', 'safety and efficacy', 'Ischemic events']","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0034580', 'cui_str': 'Radioimmunoassay'}, {'cui': 'C0580203', 'cui_str': 'Postprocedural period'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0247025', 'cui_str': 'tirofiban'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",200.0,0.0699185,"Ischemic events were noted for 8.33% (3/36) of patients in DAPT group, and 4.17% (3/72) in tirofiban group within 24 h after procedure(P = 0.398).","[{'ForeName': 'Guangchen', 'Initials': 'G', 'LastName': 'Shen', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing Jiangsu Province 210029, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing Jiangsu Province 210029, China.'}, {'ForeName': 'Linbo', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing Jiangsu Province 210029, China.'}, {'ForeName': 'Guangdong', 'Initials': 'G', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing Jiangsu Province 210029, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing Jiangsu Province 210029, China.'}, {'ForeName': 'Haibin', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing Jiangsu Province 210029, China. Electronic address: shihb@njmu.edu.cn.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2022.107132']
2049,35151026,Photobiomodulation therapy applied during an exercise-training program does not promote additional effects in trained individuals: A randomized placebo-controlled trial.,"BACKGROUND


Previous studies have shown positive results of photobiomodulation (PBM) for improving performance and accelerating post-exercise recovery. However, the effects of PBM in healthy individuals who underwent a neuromuscular adaptation training remain unclear.
OBJECTIVE


To investigate the effects of PBM during a training program combining sprints and explosive squats exercises on clinical, functional, and systemic outcomes in trained healthy individuals compared to a placebo intervention and a control.
METHODS


We conducted a randomized placebo-controlled trial. Healthy males were randomly assigned to three groups: active PBM (30 J per site), placebo, or control (passive recovery). The participants performed a six-week (12 sessions) of a training program consisting of a combination of sprints and squats with recovery applied between sprints and squats. To prevent the influence of the primary neuromuscular adaptation to exercise on the results, all participants had to participate in a period of six weeks of exercise training program. Functional, clinical, and psychological outcomes and vascular endothelial growth factor (VEGF) were assessed at baseline and after six weeks. Results are expressed as mean difference (MD) and 95% confidence intervals (CI).
RESULTS


Thirty-nine healthy male volunteers (aged 18-30 years; body mass index 23.9 ± 3 kg/m²) were recruited. There was no significant time by group interaction, and no significant effect of group, but there was a significant effect of time for maximal voluntary isometric contraction (primary outcome) (MD=22 Nm/kg; 95%CI: 3.9, 40) and for squat jump (MD=1.6 cm; 95CI%: 0.7, 2.5). There was no significant interaction (time*group), time, or group effect for the other outcomes.
CONCLUSION


The addition of PBM to a combined training performed for six weeks in previously trained individuals did not result in additional benefits compared to placebo or no additional intervention.",2022,The addition of PBM to a combined training performed for six weeks in previously trained individuals did not result in additional benefits compared to placebo or no additional intervention.,"['Thirty-nine healthy male volunteers (aged 18-30 years; body mass index 23.9\u202f±\u202f3\u202fkg/m²) were recruited', 'healthy individuals who underwent a neuromuscular adaptation training remain unclear', 'Healthy males', 'trained individuals', 'trained healthy individuals']","['placebo', 'exercise training program', 'placebo, or control (passive recovery', 'active PBM', 'photobiomodulation (PBM', 'PBM', 'training program consisting of a combination of sprints and squats with recovery applied between sprints and squats', 'placebo intervention']","['clinical, functional, and systemic outcomes', 'maximal voluntary isometric contraction', 'Functional, clinical, and psychological outcomes and vascular endothelial growth factor (VEGF']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}]",39.0,0.105701,The addition of PBM to a combined training performed for six weeks in previously trained individuals did not result in additional benefits compared to placebo or no additional intervention.,"[{'ForeName': 'Aryane F', 'Initials': 'AF', 'LastName': 'Machado', 'Affiliation': 'Post Graduate Program in Physical Therapy, Universidade Estadual Paulista (UNESP), Presidente Prudente, SP, Brazil. Electronic address: ary_machado@hotmail.com.'}, {'ForeName': 'Ernesto Cesar P', 'Initials': 'ECP', 'LastName': 'Leal-Junior', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health, Post Graduate Program in Rehabilitation Sciences, Universidade Nove de Julho (UNINOVE), São Paulo, SP, Brazil.'}, {'ForeName': 'Natanael P', 'Initials': 'NP', 'LastName': 'Batista', 'Affiliation': 'Post Graduate Program in Physical Therapy, Universidade Estadual Paulista (UNESP), Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Rafael M C P P', 'Initials': 'RMCPP', 'LastName': 'Espinoza', 'Affiliation': 'Post Graduate Program in Physical Therapy, Universidade Estadual Paulista (UNESP), Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Rodolfo B R', 'Initials': 'RBR', 'LastName': 'Hidalgo', 'Affiliation': 'Post Graduate Program in Physical Therapy, Universidade Estadual Paulista (UNESP), Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Flavia A', 'Initials': 'FA', 'LastName': 'Carvalho', 'Affiliation': 'Post Graduate Program in Physical Therapy, Universidade Estadual Paulista (UNESP), Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Jéssica K', 'Initials': 'JK', 'LastName': 'Micheletti', 'Affiliation': 'Post Graduate Program in Physical Therapy, Universidade Estadual Paulista (UNESP), Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Franciele M', 'Initials': 'FM', 'LastName': 'Vanderlei', 'Affiliation': 'Post Graduate Program in Physical Therapy, Universidade Estadual Paulista (UNESP), Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Carlos Marcelo', 'Initials': 'CM', 'LastName': 'Pastre', 'Affiliation': 'Post Graduate Program in Physical Therapy, Universidade Estadual Paulista (UNESP), Presidente Prudente, SP, Brazil.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2021.100388']
2050,35151971,Venlafaxine can reduce the migraine attacks as well as amitriptyline: A noninferiority randomized trial.,"OBJECTIVES


Migraine, as a primary headache, is among the leading causes of disability worldwide. The present study aimed at comparing the effects of venlafaxine (VLF) and amitriptyline (AMT) reducing the severity and the number of migraine attacks.
METHODS


Patients with complaints of migraine attacks were randomly divided into two groups. The first group received amitriptyline at a dose of 25 mg every night, and the second group received venlafaxine at a dose of 37.5 mg daily. The duration of treatment was eight weeks.
RESULTS


Eighty patients participated in the current study, out of which 57.5% were females. The mean age of the participants was 33 years, and the mean duration of disease was eight years. Both amitriptyline and venlafaxine significantly reduced the number of attacks per month (AMT: from 10.98 to 2.98, VLF: from 9.98 to 3.18), and six-item Headache Impact Test (HIT-6) score (AMT: from 67.78 to 49.73, VLF: from 66.65 to 48.88), and no significant difference was observed between the two drugs. The results demonstrated no significant relationship between age or disease duration with the score of the HIT-6. The decrease rate in the score of the HIT-6 in males was higher than that of females which shows the modifier role of the gender. Besides, it is noteworthy to mention that the adverse effects of amitriptyline exceeded the venlafaxine among the patients.
CONCLUSION


The effectiveness of AMT and VLF in terms of their potential to reduce the intensity and duration of headaches was more noticeable in male patients than female patients. In terms of adverse drug reactions, patients in the amitriptyline group complained more about adverse drug reactions (ADR) than patients in the venlafaxine group. It seems that in similar conditions, venlafaxine could have priority over amitriptyline in migraine prophylaxis.",2022,"In terms of adverse drug reactions, patients in the amitriptyline group complained more about adverse drug reactions (ADR) than patients in the venlafaxine group.","['Patients with complaints of migraine attacks', 'male patients than female patients', 'Eighty patients participated in the current study, out of which 57.5% were females']","['amitriptyline and venlafaxine', 'AMT and VLF', 'venlafaxine', 'venlafaxine (VLF) and amitriptyline (AMT', 'amitriptyline', 'Venlafaxine']","['migraine attacks', 'six-item Headache Impact Test (HIT-6) score (AMT', 'number of attacks per month (AMT', 'intensity and duration of headaches', 'adverse drug reactions (ADR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002600', 'cui_str': 'Amitriptyline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}]",80.0,0.0579196,"In terms of adverse drug reactions, patients in the amitriptyline group complained more about adverse drug reactions (ADR) than patients in the venlafaxine group.","[{'ForeName': 'Mohaddeseh', 'Initials': 'M', 'LastName': 'Hedayat', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Urmia, University of Medical Sciences, Urmia, Iran.. Electronic address: hedayat.m@umsu.ac.ir.'}, {'ForeName': 'Surena', 'Initials': 'S', 'LastName': 'Nazarbaghi', 'Affiliation': 'Department of neurology, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran.. Electronic address: nazarbaghi_s@umsu.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Heidari', 'Affiliation': 'Clinical Research Development Unit of Imam Khomeini Hospital, Urmia University of Medical Sciences, Urmia, Iran.. Electronic address: heidari.m@umsu.ac.ir.'}, {'ForeName': 'Hamdollah', 'Initials': 'H', 'LastName': 'Sharifi', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran.. Electronic address: sharifi.h@umsu.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2022.107151']
2051,35152127,Sub dissociative dose of ketamine with haloperidol versus fentanyl on pain reduction in patients with acute pain in the emergency department; a randomized clinical trial.,"BACKGROUND


Ketamine is known to be an effective factor in reducing pain without significant side effects.
OBJECTIVE


One of the limited side effects of Ketamine is agitation. Due to the reduction of this symptom with Haloperidol, we decided to design a randomized clinical trial to compare the analgesic effect of Ketamine with Haloperidol and Fentanyl in reducing acute pain and its complications.
METHODS


In this study, 200 adult patients who presented to the emergency department with acute pain are examined. They are randomly divided into two groups. One group received intravenous Ketamine with Haloperidol and the other group received intravenous Fentanyl. Patients are then compared for their pain score before and after administration of the drugs, as well as the side effects they experienced.
RESULTS


There was no significant difference between the mean scores of initial pain in the two groups, but at all intervals of 5, 10, 15 and 30 min after injection, the mean of pain scores of patients in the group receiving Ketamine and Haloperidol were lower. The need for injection of rescue analgesic was 9% in the Ketamine and Haloperidol group and 34% in the Fentanyl group. The mean agitation score did not differ between the two groups except in the tenth minute. At tenth minute, the mean agitation score of the Ketamine group was higher.
CONCLUSION


Ketamine works better than fentanyl in controlling acute pain, and limited side effect of agitation can be controlled if injected with haloperidol. Due to its better function and fewer side effects, it seems that in controlling acute pain, Ketamine along with Haloperidol can be a good alternative to opioids.",2022,"There was no significant difference between the mean scores of initial pain in the two groups, but at all intervals of 5, 10, 15 and 30 min after injection, the mean of pain scores of patients in the group receiving Ketamine and Haloperidol were lower.","['200 adult patients who presented to the emergency department with acute pain are examined', 'patients with acute pain in the emergency department']","['intravenous Fentanyl', 'haloperidol', 'Ketamine', 'fentanyl', 'Ketamine with Haloperidol', 'Ketamine with Haloperidol and Fentanyl', 'ketamine with haloperidol', 'Haloperidol']","['mean of pain scores', 'mean agitation score', 'acute pain and its complications', 'mean scores of initial pain', 'pain score', 'pain reduction']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",200.0,0.127288,"There was no significant difference between the mean scores of initial pain in the two groups, but at all intervals of 5, 10, 15 and 30 min after injection, the mean of pain scores of patients in the group receiving Ketamine and Haloperidol were lower.","[{'ForeName': 'Mohammad Matin', 'Initials': 'MM', 'LastName': 'Moradi', 'Affiliation': 'Prehospital and Hospital Emergency Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Mobin', 'Initials': 'MM', 'LastName': 'Moradi', 'Affiliation': 'Prehospital and Hospital Emergency Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Safaie', 'Affiliation': 'Prehospital and Hospital Emergency Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: a-safaie@sina.tums.ac.ir.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Baratloo', 'Affiliation': 'Prehospital and Hospital Emergency Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: arbaratloo@sina.tums.ac.ir.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Payandemehr', 'Affiliation': 'Prehospital and Hospital Emergency Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: p-payandemehr@sina.tums.ac.ir.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2022.02.012']
2052,35152961,Point-of-Care Synchronous Virtual Radiology Consultations for Atherosclerotic Disease in Primary Care: A Cluster-Randomized Study.,"PURPOSE


Synchronous virtual visits are an emerging model of care, and their feasibility has been demonstrated in radiology. The purpose of this study was to assess the value of point-of-care virtual radiology primary care consultations for atherosclerotic vascular disease management.
METHODS


In this institutional review board-approved study, 107 age- and gender-matched patients were assigned to control (n = 62) and intervention (n = 45) arms with the following inclusion criteria: (1) age > 45 years, (2) consult with a primary care physician (PCP), and (3) recent CT of the chest or abdomen demonstrating atherosclerotic calcification. In the intervention arm, virtual real-time radiology consultation with referring PCPs and patients was conducted, with review of CT images focused on the extent of vascular atherosclerosis. Patients in the control arm followed the current standard of care of PCPs' discussing relevant imaging results, if any.
RESULTS


Thirty-one patients in the intervention arm and 31 patients in the control arm completed the study (control: 64.5% women; mean age, 68 years; intervention: 67.7% women; mean age, 67 years). Discussion of imaging findings occurred with all patients in the intervention arm (discussion with PCP and virtual consultation with radiologist) and with 45% of patients in the control arm (PCP only; P < .001). All patients in the intervention arm indicated that seeing or discussing their images improved their understanding of their disease, compared with 85% of patients in the control arm (P = .04). In the intervention arm, 10 of 31 patients (32.2%) left the visit with changes in prescriptions for statins or antihypertensive medications, compared with only 4 of 31 patients (13%) in the control arm (P = .04).
CONCLUSIONS


Point-of-care radiology virtual visits enhance patient understanding and may influence the longitudinal management of atherosclerotic disease in primary care.",2022,"All patients in the intervention arm indicated that seeing or discussing their images improved their understanding of their disease, compared with 85% of patients in the control arm (P = .04).","['107 age- and gender-matched patients', 'Atherosclerotic Disease in Primary Care', 'Thirty-one patients in the intervention arm and 31 patients in the control arm completed the study (control: 64.5% women; mean age, 68 years; intervention: 67.7% women; mean age, 67 years']","['primary care physician (PCP), and (3) recent CT of the chest or abdomen demonstrating atherosclerotic calcification']",['seeing or discussing their images improved their understanding of their disease'],"[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}]","[{'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",107.0,0.021661,"All patients in the intervention arm indicated that seeing or discussing their images improved their understanding of their disease, compared with 85% of patients in the control arm (P = .04).","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Panagides', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Nikhita', 'Initials': 'N', 'LastName': 'Nambiar', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Chinn', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Kambadakone', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bennett', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Evita', 'Initials': 'E', 'LastName': 'Joseph', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Dania', 'Initials': 'D', 'LastName': 'Daye', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts; Director, Precision Interventional and Medical Imaging Laboratory, Massachusetts General Hospital, Boston, Massachusetts. Electronic address: ddaye@mgh.harvard.edu.'}]",Journal of the American College of Radiology : JACR,['10.1016/j.jacr.2021.10.013']
2053,35152940,Moulded cast compared with K-wire fixation after manipulation of an acute dorsally displaced distal radius fracture: the DRAFFT 2 RCT.,"BACKGROUND


Patients with a displaced fracture of the distal radius are frequently offered surgical fixation. Manipulation of the fracture and moulded plaster casting is an alternative treatment that avoids metal implants, but evidence of its effectiveness is lacking.
OBJECTIVE


To compare functional outcomes, quality-of-life outcomes, complications and resource use among patients with a dorsally displaced fracture of the distal radius treated with manipulation and surgical fixation with Kirschner wires (K-wires) and those treated with manipulation and moulded cast.
DESIGN


Pragmatic, superiority, multicentre, randomised controlled trial with a health economic evaluation.
SETTING


A total of 36 orthopaedic trauma centres in the UK NHS.
PARTICIPANTS


Patients (aged ≥ 16 years) treated for an acute dorsally displaced fracture of the distal radius were potentially eligible. Patients were excluded if their injury had occurred > 2 weeks previously, if the fracture was open, if it extended > 3 cm from the radiocarpal joint or if it required open reduction, or if the participant was unable to complete questionnaires.
INTERVENTIONS


Participants were randomly assigned in theatre (1 : 1) to receive a moulded cast (i.e. the cast group) or surgical fixation with K-wires (i.e. the K-wire group) after fracture manipulation.
MAIN OUTCOME MEASURES


The primary outcome measure was the Patient-Rated Wrist Evaluation score at 12 months, analysed on an intention-to-treat basis. Health-related quality of life was recorded using the EuroQol-5 Dimensions, five-level version, and resource use was recorded from a health and personal social care perspective.
RESULTS


Between January 2017 and March 2019, 500 participants (mean age 60 years, 83% women) were randomly allocated to receive a moulded cast ( n  = 255) or surgical fixation with K-wire ( n  = 245) following a manipulation of their fracture. A total of 395 (80%) participants were included in the primary analysis at 12 months. There was no difference in the Patient-Rated Wrist Evaluation score at 1 year post randomisation [cast group:  n  = 200, mean score 21.2 (standard deviation 23.1); K-wire group:  n  = 195, mean score 20.7 (standard deviation 22.3); adjusted mean difference -0.34 (95% confidence interval -4.33 to 3.66);  p  = 0.87]. A total of 33 (13%) participants in the cast group required surgical fixation for loss of fracture position in the first 6 weeks, compared with one participant in the K-wire group (odds ratio 0.02, 95% confidence interval 0.001 to 0.10). The base-case cost-effectiveness analysis showed that manipulation and surgical fixation with K-wires had a higher mean cost than manipulation and a moulded cast, despite similar mean effectiveness. The use of K-wires is unlikely to be cost-effective, and sensitivity analyses found this result to be robust.
LIMITATIONS


Because the interventions were identifiable, neither patients nor clinicians could be blind to their treatment.
CONCLUSIONS


Surgical fixation with K-wires was not found to be superior to moulded casting following manipulation of a dorsally displaced fracture of the distal radius, as measured by Patient-Rated Wrist Evaluation score. However, one in eight participants treated in a moulded cast required surgery for loss of fracture reduction in the first 6 weeks. After a successful closed reduction, clinicians may consider a moulded cast as a safe and cost-effective alternative to surgical fixation with K-wires.
FUTURE WORK


Further research should focus on optimal techniques for immobilisation and manipulation of this type of fracture, including optimal analgesia, and for rehabilitation of the patient after immobilisation.
TRIAL REGISTRATION


This trial is registered as ISRCTN11980540 and UKCRN Portfolio 208830.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 26, No. 11. See the NIHR Journals Library website for further project information.",2022,"Surgical fixation with K-wires was not found to be superior to moulded casting following manipulation of a dorsally displaced fracture of the distal radius, as measured by Patient-Rated Wrist Evaluation score.","['Patients were excluded if their injury had occurred >\u20092 weeks previously, if the fracture was open, if it extended >\u20093\u2009cm from the radiocarpal joint or if it required open reduction, or if the participant was unable to complete questionnaires', 'A total of 36 orthopaedic trauma centres in the UK NHS', 'Patients (aged ≥\u200916 years) treated for an acute dorsally displaced fracture of the distal radius were potentially eligible', 'patients with a dorsally displaced fracture of the distal radius treated with', 'Between January 2017 and March 2019, 500 participants (mean age 60 years, 83% women', 'A total of 395 (80%) participants were included in the primary analysis at 12 months', 'Patients with a displaced fracture of the distal radius']","['manipulation and surgical fixation with Kirschner wires (K-wires', 'moulded cast (i.e. the cast group) or surgical fixation with K-wires (i.e. the K-wire group) after fracture manipulation', 'Moulded cast compared with K-wire fixation', 'moulded cast ( n \u2009=\u2009255) or surgical fixation with K-wire', 'manipulation and moulded cast']","['Patient-Rated Wrist Evaluation score', 'functional outcomes, quality-of-life outcomes, complications and resource use', 'fracture reduction', 'Health-related quality of life', 'surgical fixation for loss of fracture position']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1322271', 'cui_str': 'Wrist joint structure'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0585059', 'cui_str': 'Fracture with displacement'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}, {'cui': 'C0369241', 'cui_str': 'Filamentous fungus'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0016641', 'cui_str': 'Fixation of fracture'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",,0.120833,"Surgical fixation with K-wires was not found to be superior to moulded casting following manipulation of a dorsally displaced fracture of the distal radius, as measured by Patient-Rated Wrist Evaluation score.","[{'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Oxford Trauma and Emergency Care, Kadoorie Research Centre, Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Juul', 'Initials': 'J', 'LastName': 'Achten', 'Affiliation': 'Oxford Trauma and Emergency Care, Kadoorie Research Centre, Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Ooms', 'Affiliation': 'Centre for Statistics in Medicine, Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'May Ee', 'Initials': 'ME', 'LastName': 'Png', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Centre for Statistics in Medicine, Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Centre for Statistics in Medicine, Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Oxford Trauma and Emergency Care, Kadoorie Research Centre, Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Lerner', 'Affiliation': 'Oxford Trauma and Emergency Care, Kadoorie Research Centre, Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kylea', 'Initials': 'K', 'LastName': 'Draper', 'Affiliation': 'Oxford Trauma and Emergency Care, Kadoorie Research Centre, Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Campolier', 'Affiliation': 'Oxford Trauma and Emergency Care, Kadoorie Research Centre, Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dakin', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'McGibbon', 'Affiliation': 'Patient and public involvement group member, Wimbourne, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Statistics and Epidemiology Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hedley', 'Affiliation': 'Department of Orthopaedics, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Dias', 'Affiliation': 'AToMS Academic Team of Musculoskeletal Surgery, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Health technology assessment (Winchester, England)",['10.3310/RLCF6332']
2054,35156933,The Challenge of Debunking Health Misinformation in Dynamic Social Media Conversations: Online Randomized Study of Public Masking During COVID-19.,"BACKGROUND


The spread of false and misleading health information on social media can cause individual and social harm. Research on debunking has shown that properly designed corrections can mitigate the impact of misinformation, but little is known about the impact of correction in the context of prolonged social media debates. For example, when a social media user takes to Facebook to make a false claim about a health-related practice and a health expert subsequently refutes the claim, the conversation rarely ends there. Often, the social media user proceeds by rebuking the critic and doubling down on the claim.
OBJECTIVE


The aim of this study was to examine the impact of such extended back and forth between false claims and debunking attempts on observers' dispositions toward behavior that science favors. We tested competing predictions about the effect of extended exposure on people's attitudes and intentions toward masking in public during the early days of the COVID-19 pandemic and explored several psychological processes potentially underlying this effect.
METHODS


A total of 500 US residents took part in an online experiment in October 2020. They reported on their attitudes and intentions toward wearing masks in public. They were then randomly assigned to one of four social media exposure conditions (misinformation only vs misinformation+correction vs misinformation+correction+rebuke vs misinformation+correction+rebuke+second correction), and reported their attitudes and intentions for a second time. They also indicated whether they would consider sharing the thread if they were to see it on social media and answered questions on potential mediators and covariates.
RESULTS


Exposure to misinformation had a negative impact on attitudes and intentions toward masking (β=-.35, 95% CI -.42 to -.29; P<.001). Moreover, initial debunking of a false claim generally improved attitudes and intentions toward masking (β=.35, 95% CI .16 to .54; P<.001). However, this improvement was washed out by further exposure to false claims and debunking attempts (β=-.53, 95% CI -.72 to -.34; P<.001). The latter result is partially explained by a decrease in the perceived objectivity of truth. That is, extended exposure to false claims and debunking attempts appear to weaken the belief that there is an objectively correct answer to how people ought to behave in this situation, which in turn leads to less positive reactions toward masking as the prescribed behavior.
CONCLUSIONS


Health professionals and science advocates face an underappreciated challenge in attempting to debunk misinformation on social media. Although engaging in extended debates with science deniers and other purveyors of bunk appears necessary, more research is needed to address the unintended consequences of such engagement.",2022,"However, this improvement is washed out by further exposure to false claims and debunking attempts (beta = -.53, 95% CI = [-.72, -.34], P < .001).",['Five hundred US residents took part in an online experiment in October 2020'],['social media exposure conditions (misinformation only vs. misinformation + correction vs. misinformation + correction + rebuke vs. misinformation + correction + rebuke + second correction'],['attitudes and intentions toward masking (beta '],"[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0449719', 'cui_str': 'Part'}]","[{'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0079843', 'cui_str': 'Misinformation'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0330390', 'cui_str': 'Beta'}]",,0.0435666,"However, this improvement is washed out by further exposure to false claims and debunking attempts (beta = -.53, 95% CI = [-.72, -.34], P < .001).","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Mourali', 'Affiliation': 'Haskayne School of Business, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Drake', 'Affiliation': 'Department of Management and Marketing, North Central College, Naperville, IL, United States.'}]",Journal of medical Internet research,['10.2196/34831']
2055,35157829,"Abemaciclib in patients with p16ink4A-deficient mesothelioma (MiST2): a single-arm, open-label, phase 2 trial.","BACKGROUND


Genetically stratified therapy for malignant mesothelioma is unavailable. Mesotheliomas frequently harbour loss of the chromosome 9p21.3 locus (CDKN2A-MTAP), which is associated with shorter overall survival due to loss of the tumour suppressor p16ink4A, an endogenous suppressor of cyclin-dependent kinase (CDK)4 and CDK6. Genetic restoration of p16ink4A suppresses mesothelioma in preclinical models, underpinning the rationale for targeting CDK4 and CDK6 in p16ink4A-negative mesothelioma. We developed a multicentre, stratified, phase 2 trial to test this hypothesis.
METHODS


The MiST2 study was a single-arm, open-label, phase 2 clinical trial done two UK centres. Patients older than 18 years with any histologically confirmed subtype of mesothelioma (pleural or peritoneal) with radiological progression after at least one course of platinum-based chemotherapy were molecularly screened by immunohistochemistry for p16ink4A. Patients with p16ink4A-negative mesothelioma were eligible for inclusion in the study. Patients were required to have measurable disease by modified Response Evaluation Criteria in Solid Tumours version 1.1 for malignant mesothelioma, a predicted life expectancy of at least 12 weeks, and an Eastern Cooperative Oncology Group performance status score of 0-1. Patients received oral abemaciclib 200 mg twice daily, administered in 28-day cycles for 24 weeks. The primary endpoint was the disease control rate (patients with complete responses, partial responses, or stable disease) at 12 weeks. The null hypothesis could be rejected if at least 11 patients had disease control. The efficacy and safety populations were defined as all patients who received at least one dose of the study drug. The study is registered with ClinicalTrials.gov, NCT03654833, and is ongoing (but MiST2 is now closed).
FINDINGS


Between Sept 31, 2019, and March 2, 2020, 27 eligible patients consented to molecular screening. The median follow-up was 18·4 weeks (IQR 6·7-23·9). One patient was excluded before treatment because of a serious adverse event before study drug allocation. 26 (100%) of 26 treated patients were p16ink4A deficient and received at least one dose of abemaciclib. Disease control at 12 weeks was reported in 14 (54%) of 26 patients (95% CI 36-71). Grade 3 or worse treatment-related adverse events (of any cause) occurred in eight (27%) of 26 patients (diarrhoea, dyspnoea, thrombocytopenia, vomiting, urinary tract infection, increased alanine aminotransferase, ascites, chest infection or suspected chest infection, neutropenic sepsis, alopecia, blood clot left calf, fall [broken neck and collar bone], haemoptysis, lower respiratory tract infection, and pulmonary embolism). Grade 3 or worse treatment-related adverse events occurred in three (12%) of 26 patients (diarrhoea, thrombocytopenia, vomiting, increased alanine aminotransferase, and pulmonary embolism). Serious adverse events occurred in six (23%) of 26 patients, leading to treatment discontinuation in one (4%) patient (diarrhoea, urinary tract infection, chest infection, neutropenic sepsis, fall [broken neck and collar bone], haemoptysis, lower respiratory tract infection, and pulmonary embolism). One patient had a serious adverse event related to abemaciclib (diarrhoea). One (4%) of 26 patients died from an adverse event (neutropenic sepsis).
INTERPRETATION


This study met its primary endpoint, showing promising clinical activity of abemaciclib in patients with p16ink4A-negative mesothelioma who were previously treated with chemotherapy, and warrants its further investigation in a randomised study as a targeted stratified therapy.
FUNDING


University of Leicester, Asthma UK and British Lung Foundation Partnership, and the Victor Dahdaleh Foundation.",2022,Disease control at 12 weeks was reported in 14 (54%) of 26 patients (95% CI 36-71).,"['patients with p16ink4A-deficient mesothelioma (MiST2', 'Patients were required to have measurable disease by modified Response Evaluation Criteria in Solid Tumours version 1.1 for malignant mesothelioma, a predicted life expectancy of at least 12 weeks, and an Eastern Cooperative Oncology Group performance status score of 0-1', '11 patients had disease control', 'patients with p16ink4A-negative mesothelioma who were previously treated with', 'Between Sept 31, 2019, and March 2, 2020', '27 eligible patients consented to molecular screening', 'Patients older than 18 years with any histologically confirmed subtype of mesothelioma (pleural or peritoneal) with radiological progression after at least one course of platinum-based chemotherapy were molecularly screened by immunohistochemistry for p16ink4A. Patients with p16ink4A-negative mesothelioma were eligible for inclusion in the study']","['chemotherapy', 'oral abemaciclib']","['diarrhoea, thrombocytopenia, vomiting, increased alanine aminotransferase, and pulmonary embolism', 'patient (diarrhoea, urinary tract infection, chest infection, neutropenic sepsis, fall [broken neck and collar bone], haemoptysis, lower respiratory tract infection, and pulmonary embolism', 'diarrhoea, dyspnoea, thrombocytopenia, vomiting, urinary tract infection, increased alanine aminotransferase, ascites, chest infection or suspected chest infection, neutropenic sepsis, alopecia, blood clot left calf, fall [broken neck and collar bone], haemoptysis, lower respiratory tract infection, and pulmonary embolism', 'Serious adverse events', 'Grade 3 or worse treatment-related adverse events', 'disease control rate (patients with complete responses, partial responses, or stable disease', 'efficacy and safety populations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0525037', 'cui_str': 'Genes, CDKN2A'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0025500', 'cui_str': 'Mesothelioma'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0345967', 'cui_str': 'Mesothelioma, malignant'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0151905', 'cui_str': 'Alanine aminotransferase increased'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0877153', 'cui_str': 'Neutropenic sepsis'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0008913', 'cui_str': 'Bone structure of clavicle'}, {'cui': 'C0019079', 'cui_str': 'Hemoptysis'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",27.0,0.131205,Disease control at 12 weeks was reported in 14 (54%) of 26 patients (95% CI 36-71).,"[{'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fennell', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, UK. Electronic address: df132@leicester.ac.uk.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'King', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Seid', 'Initials': 'S', 'LastName': 'Mohammed', 'Affiliation': 'Leicester Clinical Trials Unit, Leicester, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Greystoke', 'Affiliation': 'Northern Cancer Research Centre, Newcastle, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Anthony', 'Affiliation': 'Leicester Clinical Trials Unit, Leicester, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Poile', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Nusrat', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Scotland', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Vina', 'Initials': 'V', 'LastName': 'Bhundia', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Branson', 'Affiliation': 'Leicester Clinical Trials Unit, Leicester, UK.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Brookes', 'Affiliation': 'Leicester Clinical Trials Unit, Leicester, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Darlison', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Dawson', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Aarti', 'Initials': 'A', 'LastName': 'Gaba', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Hutka', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Morgan', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Bajaj', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Richards', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wells-Jordan', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Leicester Cancer Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(22)00062-6']
2056,35157781,"Bioequivalence and Safety of Levetiracetam Granules and Oral Solution: A Randomized, Single-Dose, 2-Period Crossover Study in Healthy Chinese Volunteers Under a Fasting Condition.","The bioequivalence and safety of levetiracetam granules (test formulation) and oral solution (reference formulation) were evaluated in Chinese healthy volunteers under a fasting condition. A total of 24 subjects randomly received the test or reference formulation at the rate of 1:1. The alternative formulation was administered after a 7-day washout period. The blood samples were collected at designated time points. Liquid chromatography-tandem mass spectrometry was applied to determine the plasma concentrations of levetiracetam. Adverse events were monitored and recorded. The 90% CIs for the geometric mean ratios of maximum plasma concentration, area under the plasma concentration-time curve from time 0 to the last quantifiable concentration, and area under the plasma concentration-time curve from time 0 to infinity between test preparation and reference preparation were 95.5% to 110.7%, 100.2% to 105.3%, and 100.3% to 105.7%, respectively, all within an acceptable bioequivalence range of 80.00% 125.00%. Both test and reference preparations were well tolerated. The trial confirmed that a single dose of 500-mg levetiracetam granules was bioequivalent to oral solution under a fasting condition, and may serve as a new dosage form of levetiracetam for clinical practice.",2022,"The trial confirmed that a single dose of 500-mg levetiracetam granules was bioequivalent to oral solution under a fasting condition, and may serve as a new dosage form of levetiracetam for clinical practice.","['24 subjects', 'Chinese healthy volunteers under a fasting condition', 'Healthy Chinese Volunteers Under a Fasting Condition']","['levetiracetam granules (test formulation) and oral solution (reference formulation', 'Levetiracetam Granules and Oral Solution', '500-mg levetiracetam']","['geometric mean ratios of maximum plasma concentration, area under the plasma concentration-time curve from time 0 to the last quantifiable concentration, and area under the plasma concentration-time curve', 'tolerated', 'blood samples', 'Adverse events', 'plasma concentrations of levetiracetam']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}]",24.0,0.0510031,"The trial confirmed that a single dose of 500-mg levetiracetam granules was bioequivalent to oral solution under a fasting condition, and may serve as a new dosage form of levetiracetam for clinical practice.","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': ""Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Yijun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': ""Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': ""Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Shuyun', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Jingying', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': ""Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': ""Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': ""Zhejiang Poly Pharmaceutical Co. Ltd., Zhejiang, People's Republic of China.""}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': ""Hangzhou Bestand Medical Technology Co. Ltd., Zhejiang, People's Republic of China.""}, {'ForeName': 'Kanyin E', 'Initials': 'KE', 'LastName': 'Zhang', 'Affiliation': ""ViaClinical Ltd., Shanghai, People's Republic of China.""}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': ""ViaClinical Ltd., Shanghai, People's Republic of China.""}, {'ForeName': 'Huahua', 'Initials': 'H', 'LastName': 'Pu', 'Affiliation': ""Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.""}]",Clinical pharmacology in drug development,['10.1002/cpdd.1063']
2057,35157622,Trauma-informed Collaborative Care for African American Primary Care Patients in Federally Qualified Health Centers: A Pilot Randomized Trial.,"BACKGROUND


African Americans have nearly double the rate of posttraumatic stress disorder (PTSD) compared with other racial/ethnic groups.
OBJECTIVE


To understand whether trauma-informed collaborative care (TICC) is effective for improving PTSD among African Americans in New Orleans who receive their care in Federally Qualified Health Centers (FQHCs).
DESIGN AND METHOD


In this pilot randomized controlled trial, we assigned patients within a single site to either TICC or to enhanced usual care (EUC). We performed intent to treat analysis by nonparametric exact tests for small sample sizes.
PARTICIPANTS


We enrolled 42 patients from October 12, 2018, through July 2, 2019. Patients were eligible if they considered the clinic their usual source of care, had no obvious physical or cognitive obstacles that would prevent participation, were age 18 or over, self-identified as African American, and had a provisional diagnosis of PTSD.
MEASURES


Our primary outcome measures were PTSD measured as both a symptom score and a provisional diagnosis based on the PTSD Checklist for DSM-5 (PCL-5).
KEY RESULTS


Nine months following baseline, both PTSD symptom scores and provisional PTSD diagnosis rates decreased substantially more for patients in TICC than in EUC. The decreases were by 26 points in EUC and 36 points in TICC for symptoms (P=0.08) and 33% in EUC and 57% in TICC for diagnosis rates (P=0.27). We found no effects for mediator variables.
CONCLUSIONS


TICC shows promise for addressing PTSD in this population. A larger-scale trial is needed to fully assess the effectiveness of this approach in these settings.",2022,The decreases were by 26 points in EUC and 36 points in TICC for symptoms (P=0.08) and 33% in EUC and 57% in TICC for diagnosis rates (P=0.27).,"['African Americans', 'Patients were eligible if they considered the clinic their usual source of care, had no obvious physical or cognitive obstacles that would prevent participation, were age 18 or over, self-identified as African American, and had a provisional diagnosis of PTSD', 'We enrolled 42 patients from October 12, 2018, through July 2, 2019', 'African American Primary Care Patients in Federally Qualified Health Centers', 'African Americans in New Orleans who receive their care in Federally Qualified Health Centers (FQHCs']","['TICC', 'TICC or to enhanced usual care (EUC', 'Trauma-informed Collaborative Care', 'trauma-informed collaborative care (TICC']","['PTSD measured as both a symptom score and a provisional diagnosis based on the PTSD Checklist for DSM-5 (PCL-5', 'PTSD symptom scores and provisional PTSD diagnosis rates', 'diagnosis rates']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332134', 'cui_str': 'Preliminary diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0700287', 'cui_str': 'Informing'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332134', 'cui_str': 'Preliminary diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",42.0,0.104309,The decreases were by 26 points in EUC and 36 points in TICC for symptoms (P=0.08) and 33% in EUC and 57% in TICC for diagnosis rates (P=0.27).,"[{'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Meredith', 'Affiliation': 'RAND Corporation, Santa Monica.'}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Wong', 'Affiliation': 'RAND Corporation, Santa Monica.'}, {'ForeName': 'Karen Chan', 'Initials': 'KC', 'LastName': 'Osilla', 'Affiliation': 'RAND Corporation, Santa Monica.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Sanders', 'Affiliation': 'Louisiana Public Health Institute, New Orleans, LA.'}, {'ForeName': 'Mahlet G', 'Initials': 'MG', 'LastName': 'Tebeka', 'Affiliation': 'Pardee RAND Graduate School, Santa Monica, CA.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Kaiser Permanente Department of Research and Evaluation, Southern California, SC.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Williamson', 'Affiliation': 'RAND Corporation, Santa Monica.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Carton', 'Affiliation': 'Louisiana Public Health Institute, New Orleans, LA.'}]",Medical care,['10.1097/MLR.0000000000001681']
2058,35157830,"Pain and health-related quality of life with olaparib versus physician's choice of next-generation hormonal drug in patients with metastatic castration-resistant prostate cancer with homologous recombination repair gene alterations (PROfound): an open-label, randomised, phase 3 trial.","BACKGROUND


The PROfound study showed significantly improved radiographical progression-free survival and overall survival in men with metastatic castration-resistant prostate cancer with alterations in homologous recombination repair genes and disease progression on a previous next-generation hormonal drug who received olaparib then those who received control. We aimed to assess pain and patient-centric health-related quality of life (HRQOL) measures in patients in the trial.
METHODS


In this open-label, randomised, phase 3 study, patients (aged ≥18 years) with metastatic castration-resistant prostate cancer and gene alterations to one of 15 genes (BRCA1, BRCA2, or ATM [cohort A] and BRIP1, BARD1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L [cohort B]) and disease progression after a previous next-generation hormonal drug were randomly assigned (2:1) to receive olaparib tablets (300 mg orally twice daily) or a control drug (enzalutamide tablets [160 mg orally once daily] or abiraterone tablets [1000 mg orally once daily] plus prednisone tablets [5 mg orally twice daily]), stratified by previous taxane use and measurable disease. The primary endpoint (radiographical progression-free survival in cohort A) has been previously reported. The prespecified secondary endpoints reported here are on pain, HRQOL, symptomatic skeletal-related events, and time to first opiate use for cancer-related pain in cohort A. Pain was assessed with the Brief Pain Inventory-Short Form, and HRQOL was assessed with the Functional Assessment of Cancer Therapy-Prostate (FACT-P). All endpoints were analysed in patients in cohort A by modified intention-to-treat. The study is registered with ClinicalTrials.gov, NCT02987543.
FINDINGS


Between Feb 6, 2017, and June 4, 2019, 245 patients were enrolled in cohort A and received study treatment (162 [66%] in the olaparib group and 83 [34%] in the control group). Median duration of follow-up at data cutoff in all patients was 6·2 months (IQR 2·2-10·4) for the olaparib group and 3·5 months (1·7-4·9) for the control group. In cohort A, median time to pain progression was significantly longer with olaparib than with control (median not reached [95% CI not reached-not reached] with olaparib vs 9·92 months [5·39-not reached] with control; HR 0·44 [95% CI 0·22-0·91]; p=0·019). Pain interference scores were also better in the olaparib group (difference in overall adjusted mean change from baseline score -0·85 [95% CI -1·31 to -0·39]; p nominal =0·0004). Median time to progression of pain severity was not reached in either group (95% CI not reached-not reached for both groups; HR 0·56 [95% CI 0·25-1·34]; p nominal =0·17). In patients who had not used opiates at baseline (113 in the olaparib group, 58 in the control group), median time to first opiate use for cancer-related pain was 18·0 months (95% CI 12·8-not reached) in the olaparib group versus 7·5 months (3·2-not reached) in the control group (HR 0·61; 95% CI 0·38-0·99; p nominal =0·044). The proportion of patients with clinically meaningful improvement in FACT-P total score during treatment was higher for the olaparib group than the control group: 15 (10%) of 152 evaluable patients had a response in the olaparib group compared with one (1%) of evaluable 77 patients in the control group (odds ratio 8·32 [95% CI 1·64-151·84]; p nominal =0·0065). Median time to first symptomatic skeletal-related event was not reached for either treatment group (olaparib group 95% CI not reached-not reached; control group 7·8-not reached; HR 0·37 [95% CI 0·20-0·70]; p nominal =0·0013).
INTERPRETATION


Olaparib was associated with reduced pain burden and better-preserved HRQOL compared with the two control drugs in men with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations who had disease progression after a previous next-generation hormonal drug. Our findings support the clinical benefit of improved radiographical progression-free survival and overall survival identified in PROfound.
FUNDING


AstraZeneca and Merck Sharp & Dohme.",2022,The proportion of patients with clinically meaningful improvement in FACT-P total score during treatment was higher for the olaparib group than the control group: 15 (10%) of 152 evaluable patients had a response in the olaparib group compared with one (1%) of evaluable 77 patients in the control group (odds ratio 8·32,"['men with metastatic castration-resistant prostate cancer', 'patients (aged ≥18 years) with metastatic castration-resistant prostate cancer and gene alterations to one of 15 genes (BRCA1, BRCA2, or ATM [cohort A', 'Between Feb 6, 2017, and June 4, 2019', 'patients in the trial', '245 patients were enrolled in cohort A and received study treatment (162 [66%] in the olaparib group and 83 [34%] in the control group', 'patients with metastatic castration-resistant prostate cancer with homologous recombination repair gene alterations (PROfound', 'disease progression after a previous next-generation hormonal drug', 'men with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations who had disease progression after a previous next-generation hormonal drug']","['olaparib tablets', 'control drug (enzalutamide tablets [160 mg orally once daily] or abiraterone tablets [1000 mg orally once daily] plus prednisone tablets', '0·39']","['pain, HRQOL, symptomatic skeletal-related events, and time to first opiate use for cancer-related pain in cohort A. Pain was assessed with the Brief Pain Inventory-Short Form, and HRQOL was assessed with the Functional Assessment of Cancer Therapy-Prostate (FACT-P', 'primary endpoint (radiographical progression-free survival', 'pain and patient-centric health-related quality of life (HRQOL) measures', 'Median time to progression of pain severity', 'FACT-P total score', 'median time to pain progression', 'Median time to first symptomatic skeletal-related event', 'Median duration', 'pain burden and better-preserved HRQOL', 'Pain and health-related quality of life', 'radiographical progression-free survival and overall survival', 'Pain interference scores', 'median time to first opiate use for cancer-related pain']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C2973986', 'cui_str': 'BRCA2 protein, human'}, {'cui': 'C0103097', 'cui_str': 'ammonium tetrathiomolybdate'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C4520027', 'cui_str': 'olaparib Oral Tablet'}, {'cui': 'C0013168', 'cui_str': 'Drug Control'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1247653', 'cui_str': 'Prednisone Oral Tablet'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",245.0,0.489469,The proportion of patients with clinically meaningful improvement in FACT-P total score during treatment was higher for the olaparib group than the control group: 15 (10%) of 152 evaluable patients had a response in the olaparib group compared with one (1%) of evaluable 77 patients in the control group (odds ratio 8·32,"[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Thiery-Vuillemin', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon, France. Electronic address: a.thieryvuillemin@mac.com.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'de Bono', 'Affiliation': 'The Institute of Cancer Research, Royal Marsden, London, UK.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Robert H Lurie Comprehensive Cancer Center, School of Medicine, Northwestern University Feinberg, Chicago, IL, USA.'}, {'ForeName': 'Guilhem', 'Initials': 'G', 'LastName': 'Roubaud', 'Affiliation': 'Department of Medical Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Procopio', 'Affiliation': 'Medical Oncology Dept, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': 'Carolina Urologic Research Center, Myrtle Beach, SC, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Institut Gustave Roussy, University of Paris Saclay, Paris, France.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Dos Anjos', 'Affiliation': 'Hospital Ernesto Dornelles, Porto Alegre, Brazil.'}, {'ForeName': 'Gwenaelle', 'Initials': 'G', 'LastName': 'Gravis', 'Affiliation': 'Centre de Recherche en Cancérologie de Marseille, Institut Paoli-Calmettes, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Joung', 'Affiliation': 'Center for Prostate Cancer, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': 'Hospital Universitario, Madrid, Spain.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Degboe', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gresty', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Poehlein', 'Affiliation': 'Merck, Kenilworth, NJ, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}]",The Lancet. Oncology,['10.1016/S1470-2045(22)00017-1']
2059,35158230,"LSD, afterglow and hangover: Increased episodic memory and verbal fluency, decreased cognitive flexibility.","Psychedelics acutely impair cognitive functions, but these impairments decline with growing experiences with psychedelics and microdoses may even exert opposing effects. Given the recent evidence that psychedelics induce neuroplasticity, this explorative study aimed at investigating the potential of psychedelics to sub-acutely change cognition. For this, we applied a randomized, double-blind, placebo-controlled, crossover study with 24 healthy volunteers receiving 50 μg lysergic acid diethylamide (LSD) or an inactive placebo. Sub-acute changes in cognition were measured 24 h after dosing, including memory (Rey-Osterrieth Complex Figure, ROCF; 2D Object-Location Memory Task, OLMT; Rey Auditory-Verbal Learning Test, RAVLT), verbal fluency (phonological; semantic; switch), design fluency (basic; filter; switch), cognitive flexibility (Wisconsin Card Sorting Test, WCST), sustained and switching attention (Trail Making Test, TMT), inhibitory control (Stroop Task) and perceptual reasoning (Block Design Test, BDT). The results show that when compared to placebo and corrected for Body Mass Index (BMI) and abstinence period from psychedelics, LSD sub-acutely improved visuospatial memory (ROCF immediate recall points and percentage, OLMT consolidation percentage) and phonological verbal fluency and impaired cognitive flexibility (WCST: fewer categories achieved; more perseveration, errors and conceptual level responses). In conclusion, the low dose of LSD moderately induced both ""afterglow"" and ""hangover"". The improvements in visuospatial memory and phonological fluency suggest that LSD-assisted therapy should be explored as a novel treatment perspective in conditions involving memory and language declines such as brain injury, stroke or dementia.",2022,"The improvements in visuospatial memory and phonological fluency suggest that LSD-assisted therapy should be explored as a novel treatment perspective in conditions involving memory and language declines such as brain injury, stroke or dementia.",['24 healthy volunteers receiving 50\xa0μg lysergic acid diethylamide (LSD) or an'],"['placebo', 'inactive placebo', 'LSD-assisted therapy']","['memory (Rey-Osterrieth Complex Figure, ROCF; 2D Object-Location Memory Task, OLMT; Rey Auditory-Verbal Learning Test, RAVLT), verbal fluency (phonological; semantic; switch), design fluency (basic; filter; switch), cognitive flexibility (Wisconsin Card Sorting Test, WCST), sustained and switching attention (Trail Making Test, TMT), inhibitory control (Stroop Task) and perceptual reasoning (Block Design Test, BDT', 'visuospatial memory and phonological fluency', 'episodic memory and verbal fluency, decreased cognitive flexibility', 'Body Mass Index (BMI) and abstinence period from psychedelics, LSD sub-acutely improved visuospatial memory (ROCF immediate recall points and percentage, OLMT consolidation percentage) and phonological verbal fluency and impaired cognitive flexibility (WCST: fewer categories achieved; more perseveration, errors and conceptual level responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C4505408', 'cui_str': 'Rey-Osterrieth Complex Figure'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin card sorting test'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0640294', 'cui_str': 'N-((2,3-dihydro-1,4-benzodioxin-2-yl)methyl)-5-methoxy-1H-indole-3-ethanamine'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}, {'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0233651', 'cui_str': 'Perseveration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",24.0,0.1924,"The improvements in visuospatial memory and phonological fluency suggest that LSD-assisted therapy should be explored as a novel treatment perspective in conditions involving memory and language declines such as brain injury, stroke or dementia.","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Wießner', 'Affiliation': 'Department of Psychiatry, School of Medical Sciences, University of Campinas, Campinas, São Paulo, Brazil; Interdisciplinary Cooperation for Ayahuasca Research and Outreach (ICARO), School of Medical Sciences, University of Campinas, Campinas, São Paulo, Brazil. Electronic address: isabel.wiessner@gmail.com.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Olivieri', 'Affiliation': 'Department of Psychiatry, School of Medical Sciences, University of Campinas, Campinas, São Paulo, Brazil; Interdisciplinary Cooperation for Ayahuasca Research and Outreach (ICARO), School of Medical Sciences, University of Campinas, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Falchi', 'Affiliation': 'Department of Psychiatry, School of Medical Sciences, University of Campinas, Campinas, São Paulo, Brazil; Interdisciplinary Cooperation for Ayahuasca Research and Outreach (ICARO), School of Medical Sciences, University of Campinas, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Palhano-Fontes', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Oliveira Maia', 'Affiliation': 'Department of Psychiatry, School of Medical Sciences, University of Campinas, Campinas, São Paulo, Brazil; Interdisciplinary Cooperation for Ayahuasca Research and Outreach (ICARO), School of Medical Sciences, University of Campinas, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, Oxford, United Kingdom.'}, {'ForeName': 'Draulio', 'Initials': 'D', 'LastName': 'B Araujo', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Sidarta', 'Initials': 'S', 'LastName': 'Ribeiro', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Luís Fernando', 'Initials': 'LF', 'LastName': 'Tófoli', 'Affiliation': 'Department of Psychiatry, School of Medical Sciences, University of Campinas, Campinas, São Paulo, Brazil; Interdisciplinary Cooperation for Ayahuasca Research and Outreach (ICARO), School of Medical Sciences, University of Campinas, Campinas, São Paulo, Brazil.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2022.01.114']
2060,35158207,First-line nivolumab + ipilimumab in advanced NSCLC: CheckMate 227 subpopulation analyses in Asian patients.,"BACKGROUND


Nivolumab plus ipilimumab demonstrated clinically meaningful improvement in efficacy versus chemotherapy with a manageable safety profile in patients with advanced non-small cell lung cancer (NSCLC) and tumor programmed death-ligand 1 (PD-L1) expression ≥1% or <1% in Part 1 of CheckMate 227. Here we report efficacy and safety results for the Asian subpopulation.
METHODS


Patients with stage IV/recurrent NSCLC were randomized 1 : 1 : 1 to nivolumab plus ipilimumab, nivolumab monotherapy, or chemotherapy (PD-L1 ≥1%) or nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy (PD-L1 <1%). Overall survival (OS), progression-free survival, objective response rate, duration of response, and safety were evaluated among patients in Japan, South Korea, and Taiwan.
RESULTS


In the Asian subpopulation with PD-L1 ≥1%, 81 patients received nivolumab plus ipilimumab and 81 received chemotherapy. Median OS was not reached with nivolumab plus ipilimumab versus 24.8 months with chemotherapy; 3-year OS rate was 53% versus 37% [hazard ratio (HR), 0.72; 95% confidence interval (CI) 0.47-1.11]. The 3-year progression-free survival rate was 26% versus 7% (HR, 0.65; 95% CI 0.45-0.96), objective response rate was 56% versus 37%, and median duration of response was 29.0 months (95% CI 15.0 months-not reached) versus 6.9 months (95% CI 3.9-11.1 months). Similar results were observed regardless of tumor PD-L1 expression and in Japanese patients. Grade 3-4 treatment-related adverse events occurred in 40% of patients receiving nivolumab plus ipilimumab and 36% receiving chemotherapy, in the overall Asian subpopulation (tumor PD-L1 expression ≥1% and <1%); no new safety signals were identified.
CONCLUSIONS


At 3-year follow-up, nivolumab plus ipilimumab provided durable long-term efficacy benefits versus chemotherapy regardless of tumor PD-L1 expression in the Asian subpopulation, including Japanese patients. Consistent with findings for all randomized patients, these data support the use of nivolumab plus ipilimumab as first-line treatment of Asian patients with advanced NSCLC.",2022,"At 3-year follow-up, nivolumab plus ipilimumab provided durable long-term efficacy benefits versus chemotherapy regardless of tumor PD-L1 expression in the Asian subpopulation, including Japanese patients.","['Asian patients with advanced NSCLC', 'patients with advanced non-small cell lung cancer (NSCLC', 'Japanese patients', 'Patients with stage IV/recurrent NSCLC', 'advanced NSCLC', 'Asian patients']","['chemotherapy', 'First-line nivolumab\xa0+ ipilimumab', 'nivolumab plus ipilimumab', 'nivolumab plus ipilimumab, nivolumab monotherapy, or chemotherapy (PD-L1 ≥1%) or nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy']","['objective response rate', 'adverse events', 'tumor PD-L1 expression', 'OS rate', '3-year progression-free survival rate', 'Overall survival (OS), progression-free survival, objective response rate, duration of response, and safety', 'median duration of response', 'Median OS']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0278517', 'cui_str': 'Non-small cell lung cancer recurrent'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.337317,"At 3-year follow-up, nivolumab plus ipilimumab provided durable long-term efficacy benefits versus chemotherapy regardless of tumor PD-L1 expression in the Asian subpopulation, including Japanese patients.","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': ""O'Byrne"", 'Affiliation': 'Princess Alexandra Hospital and Queensland University of Technology, Brisbane, Australia. Electronic address: k.obyrne@qut.edu.au.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Cheongju-si, Republic of Korea.'}, {'ForeName': 'S-W', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sakai', 'Affiliation': 'Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fukuhara', 'Affiliation': 'Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'J-H', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': ""The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Daga', 'Affiliation': 'Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'C-J', 'Initials': 'CJ', 'LastName': 'Yu', 'Affiliation': 'National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu, Taiwan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Takeda', 'Affiliation': 'Kindai University Hospital, Osaka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yokoyama', 'Affiliation': 'Kurashiki Central Hospital, Kurashiki, Japan.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Nathan', 'Affiliation': 'Bristol Myers Squibb, Princeton, USA.'}, {'ForeName': 'J-S', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}]",ESMO open,['10.1016/j.esmoop.2022.100394']
2061,35162507,"Effects of a 12-Week Diet versus Diet plus Aerobic and Resistance Exercise Program on Acylated and Desacylated Ghrelin, and Ghrelin O-Acyltransferase in Adolescent Girls with Obesity.","This study investigated the effects of a 12-week diet versus diet plus aerobic and resistance exercise programme on acylated ghrelin (AG), desacylated ghrelin (DAG), and ghrelin O-acyltransferase (GOAT) concentrations in girls with obesity. We randomised 30 adolescents with obesity to a 12-week aerobic and resistance exercise group (EG) or a control group (CG). At baseline and at 4, 8, and 12 weeks, we measured their body composition, lipid profile, glucose, AG, DAG, and GOAT concentrations. In the EG, the body fat percentage decreased by 2.37% and was significantly lower than that in the CG. The DAG concentrations significantly increased by 48.3% and 27.4% in the EG and CG, respectively. At 4, 8, and 12 weeks, DAG concentrations were significantly higher in the EG than in the CG. AG concentrations were higher at week 12 than at baseline in both groups. In both groups, the GOAT concentrations increased at weeks 8 and 12; however, no between-group differences were observed in the changes in GOAT concentrations. This study showed increased DAG concentrations and non-significant changes in AG and GOAT concentrations after a 12-week aerobic and resistance exercise programme in girls with obesity. These findings suggest that an aerobic and resistance exercise programme influences appetite-regulating hormones, mainly through changes in DAG concentrations.",2022,"In both groups, the GOAT concentrations increased at weeks 8 and 12; however, no between-group differences were observed in the changes in GOAT concentrations.","['girls with obesity', 'Adolescent Girls with Obesity', '30 adolescents with obesity to a 12-week']","['aerobic and resistance exercise programme', '12-Week Diet versus Diet plus Aerobic and Resistance Exercise Program', 'diet versus diet plus aerobic and resistance exercise programme', 'aerobic and resistance exercise group (EG) or a control group (CG']","['AG concentrations', 'acylated ghrelin (AG), desacylated ghrelin (DAG), and ghrelin O-acyltransferase (GOAT) concentrations', 'AG and GOAT concentrations', 'GOAT concentrations', 'body fat percentage', 'DAG concentrations', 'body composition, lipid profile, glucose, AG, DAG, and GOAT concentrations']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",30.0,0.0416109,"In both groups, the GOAT concentrations increased at weeks 8 and 12; however, no between-group differences were observed in the changes in GOAT concentrations.","[{'ForeName': 'Hyun Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Education, Kyungnam University, Changwon 51767, Korea.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Tak', 'Affiliation': 'Biomedical Research Institute, Pusan National University Hospital, Busan 49241, Korea.'}, {'ForeName': 'Sang Yeoup', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Family Medicine Clinic, Biomedical Research Institute, Pusan National University Yangsan Hospital, Yangsan 50612, Korea.'}, {'ForeName': 'Jeong Pyo', 'Initials': 'JP', 'LastName': 'Seo', 'Affiliation': ""Sehwa Girls' High School, Changwon 51581, Korea.""}]",International journal of environmental research and public health,['10.3390/ijerph19031480']
2062,35162500,Vibration or Transcutaneous Tibial Nerve Stimulation as a Treatment for Sexual Dysfunction in Women with Spinal Cord Injury: Study Protocol for a Randomized Clinical Trial.,"BACKGROUND


Women with spinal cord injuries usually suffer from sexual dysfunction, such as alterations during arousal and an increase in the time to reach orgasm. However, little evidence has been found on its physiotherapeutic approach, as well as poor adherence to the latter. The aim of this study is to determine the effectiveness of two interventions to improve sexual dysfunction: the application of genital vibration and transcutaneous tibial nerve stimulation.
METHODS


This is a randomized clinical trial that will recruit 54 women who, one year after a spinal cord injury, suffer from sexual dysfunction associated with the latter. The participants will be randomized to three groups: (a) intervention group 1 treated with transcutaneous tibial nerve electrostimulation ( n  = 18), (b) intervention group 2 treated with genital vibration ( n  = 18), and (c) a control group ( n  = 18). The treatment time will be 12 weeks. Adherence to the treatment will be evaluated, as well as the effectiveness of the treatment, through the Female Sexual Function Index, the Sexual Quality of Life-Female questionnaire, quantitative sensory tests, and the improvement reported by the patient in terms of arousal and orgasm. The evaluations will be carried out before the treatment, at the end of the treatment and 3, 6 and 12 months after the end of the treatment.",2022,"The aim of this study is to determine the effectiveness of two interventions to improve sexual dysfunction: the application of genital vibration and transcutaneous tibial nerve stimulation.
","['Sexual Dysfunction in Women with Spinal Cord Injury', '54 women who, one year after a spinal cord injury, suffer from sexual dysfunction associated with the latter']","['genital vibration and transcutaneous tibial nerve stimulation', 'Vibration or Transcutaneous Tibial Nerve Stimulation', 'intervention group 1 treated with transcutaneous tibial nerve electrostimulation ( n  = 18), (b) intervention group 2 treated with genital vibration']",['sexual dysfunction'],"[{'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0549622', 'cui_str': 'Sexual disorder'}]",54.0,0.0294234,"The aim of this study is to determine the effectiveness of two interventions to improve sexual dysfunction: the application of genital vibration and transcutaneous tibial nerve stimulation.
","[{'ForeName': 'María Del-Carmen', 'Initials': 'MD', 'LastName': 'Díaz-Ruiz', 'Affiliation': 'Department of Physiotherapy, Aranjuez Nursing Home Center, 28300 Madrid, Spain.'}, {'ForeName': 'Rita-Pilar', 'Initials': 'RP', 'LastName': 'Romero-Galisteo', 'Affiliation': 'Department of Physiotherapy, Faculty of Science Health, University of Málaga, 29016 Málaga, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Arranz-Martín', 'Affiliation': 'Department of Nursing, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursing, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Palomo-Carrión', 'Affiliation': 'Department of Nursing, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursing, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ando-Lafuente', 'Affiliation': 'Department of Nursing, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursing, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lirio-Romero', 'Affiliation': 'Department of Nursing, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursing, University of Castilla-La Mancha, 45071 Toledo, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph19031478']
2063,35162482,HAPPY MAMA Project (Part 2)-Maternal Distress and Self-Efficacy: A Pilot Randomized Controlled Field Trial.,"INTRODUCTION


The aim of the pilot randomized controlled field trial is to assess if a midwifery intervention is able to increase the maternal self-efficacy and reduce the stress level during the first six months after birth.
METHODS


The study was conducted in two different hospitals in Rome, Italy, involving women delivering at or beyond term, aged >18 years old and with normal APGAR scores of the infant. The participants were randomly divided into two groups: "" Individual Intervention Group "" (they received home midwifery assistance for one month after birth, I) and the "" Control Group "" (C). A self-administered questionnaire was administered four times: at the baseline about one week after the hospital delivery (T0), after the intervention about one month after the delivery (T1), and at three months (T2) and at six months after birth (T3). The questionnaire included different validated scales needed to assess maternal perceived self-efficacy (KPCS), parental stress scale stress (PSS) and maternal depressive risk symptoms (EPDS).
RESULTS


The study population counted 51 mothers: 28 women in the ""C"" group and 23 women in the ""I"" group. The PSS score was statistically higher in the ""C"" than ""I"" group at T1 ( p  = 0.024); whereas the KPCS score was statistically higher in the ""I"" ( p  = 0.039) group; EPDS score did not show significant difference between the two groups in the follow-up period. An inverse significant correlation between KPCS and PSS was found during the study window time ( p  < 0.0001).
CONCLUSIONS


These results potentially give the opportunity to explore this area of focus further, in order to better address maternal individual needs for the successful transition to motherhood. More research in this area is required.",2022,"The PSS score was statistically higher in the ""C"" than ""I"" group at T1 ( p  = 0.024); whereas the KPCS score was statistically higher in the ""I"" ( p  = 0.039) group; EPDS score did not show significant difference between the two groups in the follow-up period.","['two different hospitals in Rome, Italy, involving women delivering at or beyond term, aged >18 years old and with normal APGAR scores of the infant', '51 mothers: 28 women in the ""C"" group and 23 women in the ""I"" group']","[' Individual Intervention Group "" (they received home midwifery assistance for one month after birth, I) and the "" Control Group "" (C']","['maternal perceived self-efficacy (KPCS), parental stress scale stress (PSS) and maternal depressive risk symptoms (EPDS', 'EPDS score', 'PSS score', 'maternal self-efficacy', 'KPCS score', 'stress level', 'HAPPY MAMA Project (Part 2)-Maternal Distress and Self-Efficacy']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1999012', 'cui_str': 'Parental role conflict'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0473485', 'cui_str': 'Maternal distress'}]",,0.0486345,"The PSS score was statistically higher in the ""C"" than ""I"" group at T1 ( p  = 0.024); whereas the KPCS score was statistically higher in the ""I"" ( p  = 0.039) group; EPDS score did not show significant difference between the two groups in the follow-up period.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Mannocci', 'Affiliation': 'Faculty of Economics, Mercatorum University, 00186 Rome, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ciavardini', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University, 00185 Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Mattioli', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University, 00185 Rome, Italy.'}, {'ForeName': 'Azzurra', 'Initials': 'A', 'LastName': 'Massimi', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University, 00185 Rome, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': ""D'Egidio"", 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University, 00185 Rome, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Lia', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University, 00185 Rome, Italy.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Scaglietta', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University, 00185 Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Giannini', 'Affiliation': 'Department of Maternal and Child Health and Urological Sciences, Umberto I Teaching Hospital, Sapienza University, 00185 Rome, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Antico', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University, 00185 Rome, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Dorelli', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University, 00185 Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Svelato', 'Affiliation': 'Department of Obstetrics and Gynecology, San Giovanni Calibita Fatebenefratelli Hospital, 00186 Rome, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Orfeo', 'Affiliation': 'Neonatal Intensive Care Unit, ""San Giovanni Calibita"" Fatebenefratelli, 00186 Rome, Italy.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Benedetti Panici', 'Affiliation': 'Department of Maternal and Child Health and Urological Sciences, Umberto I Teaching Hospital, Sapienza University, 00185 Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ragusa', 'Affiliation': 'Department of Obstetrics and Gynecology, San Giovanni Calibita Fatebenefratelli Hospital, 00186 Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'La Torre', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University, 00185 Rome, Italy.'}, {'ForeName': 'Happy Mama', 'Initials': 'HM', 'LastName': 'Group', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University, 00185 Rome, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph19031461']
2064,35162447,"Acute Effects of Tissue Flossing Coupled with Functional Movements on Knee Range of Motion, Static Balance, in Single-Leg Hop Distance, and Landing Stabilization Performance in Female College Students.","Flexibility, specifically that in the amplitude of sagittal-plane range of motion (ROM), can improve jump landing patterns and reduce the potential for sports injury. The use of floss bands (FLOSS) reportedly increases joint range of motion (ROM) in the shoulder, ankle, and elbow joints. However, little research on the effectiveness of FLOSS on the knee joint has been conducted. This study investigated the effects of FLOSS on knee ROM, static balance, single-leg-hop distance, and landing stabilization performance in women. This study had a crossover design. Twenty active female college students without musculoskeletal disorders were randomly assigned to receive a FLOSS intervention or elastic bandage (ELA) control on their dominant knees. The participants underwent FLOSS and ELA activities on two occasions with 48 h of rest between both sets of activities. The outcomes were flexibility of the quadriceps and hamstrings, how long one could maintain a single-leg stance (with and without eyes closed), distance on a single-leg triple hop, and score on the Landing Error Scoring System (LESS); these outcomes were evaluated at preintervention and postintervention (immediately following band removal and 20 min later). After the FLOSS intervention, the participants' hamstring flexibility improved significantly (immediately after:  p  = 0.001; 20 min later:  p  = 0.002), but their quadricep flexibility did not. In addition, FLOSS use did not result in worse single-leg stance timing, single-leg triple-hop distance, or landing stabilization performance relative to ELA use. Compared with the ELA control, the FLOSS intervention yielded significantly better LESS at 20 min postintervention ( p  = 0.032), suggesting that tissue flossing can improve landing stability. In conclusion, the application of FLOSS to the knee improves hamstring flexibility without impeding static balance, and improves single-leg hop distance and landing stabilization performance in women for up to 20 min. Our findings elucidate the effects of tissue flossing on the knee joint and may serve as a reference for physiotherapists or athletic professionals in athletic practice settings.",2022,"After the FLOSS intervention, the participants' hamstring flexibility improved significantly (immediately after:  p  = 0.001; 20 min later:  p  = 0.002), but their quadricep flexibility did not.","['women', 'Twenty active female college students without musculoskeletal disorders', 'Female College Students']","['FLOSS intervention or elastic bandage (ELA) control on their dominant knees', 'FLOSS', 'floss bands (FLOSS', 'Tissue Flossing Coupled with Functional Movements']","['flexibility of the quadriceps and hamstrings, how long one could maintain a single-leg stance (with and without eyes closed), distance on a single-leg triple hop, and score on the Landing Error Scoring System (LESS', 'knee ROM, static balance, single-leg-hop distance, and landing stabilization performance', 'landing stability', 'single-leg hop distance and landing stabilization performance', 'worse single-leg stance timing, single-leg triple-hop distance, or landing stabilization performance', 'jump landing patterns', 'Knee Range of Motion, Static Balance, in Single-Leg Hop Distance, and Landing Stabilization Performance', 'joint range of motion (ROM', 'hamstring flexibility', 'quadricep flexibility']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}]","[{'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336591', 'cui_str': 'Elastic bandage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",20.0,0.0372358,"After the FLOSS intervention, the participants' hamstring flexibility improved significantly (immediately after:  p  = 0.001; 20 min later:  p  = 0.002), but their quadricep flexibility did not.","[{'ForeName': 'Szu-Ying', 'Initials': 'SY', 'LastName': 'Wu', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 833, Taiwan.'}, {'ForeName': 'Yi-Hsun', 'Initials': 'YH', 'LastName': 'Tsai', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 833, Taiwan.'}, {'ForeName': 'Yu-Ting', 'Initials': 'YT', 'LastName': 'Wang', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Wen-Dien', 'Initials': 'WD', 'LastName': 'Chang', 'Affiliation': 'Department of Sport Performance, National Taiwan University of Sport, Taichung 404, Taiwan.'}, {'ForeName': 'Chia-Lun', 'Initials': 'CL', 'LastName': 'Lee', 'Affiliation': 'Center for Physical and Health Education, National Sun Yat-Sen University, Kaohsiung 804, Taiwan.'}, {'ForeName': 'Chun-En Aurea', 'Initials': 'CA', 'LastName': 'Kuo', 'Affiliation': 'Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 833, Taiwan.'}, {'ForeName': 'Nai-Jen', 'Initials': 'NJ', 'LastName': 'Chang', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph19031427']
2065,35162424,Assessment of Bi-Ventricular and Bi-Atrial Areas Using Four-Chamber Cine Cardiovascular Magnetic Resonance Imaging: Fully Automated Segmentation with a U-Net Convolutional Neural Network.,"Four-chamber (4CH) cine cardiovascular magnetic resonance imaging (CMR) facilitates simultaneous evaluation of cardiac chambers; however, manual segmentation is time-consuming and subjective in practice. We evaluated deep learning based on a U-Net convolutional neural network (CNN) for fully automated segmentation of the four cardiac chambers using 4CH cine CMR. Cine CMR datasets from patients were randomly assigned for training (1400 images from 70 patients), validation (600 images from 30 patients), and testing (1000 images from 50 patients). We validated manual and automated segmentation based on the U-Net CNN using the dice similarity coefficient (DSC) and Spearman's rank correlation coefficient ( ρ );  p  < 0.05 was statistically significant. The overall median DSC showed high similarity (0.89). Automated segmentation correlated strongly with manual segmentation in all chambers-the left and right ventricles, and the left and right atria (end-diastolic area:  ρ  = 0.88, 0.76, 0.92, and 0.87; end-systolic area:  ρ  = 0.81, 0.81, 0.92, and 0.83, respectively;  p  < 0.01). The area under the curve for the left ventricle, left atrium, right ventricle, and right atrium showed high scores (0.96, 0.99, 0.88, and 0.96, respectively). Fully automated segmentation could facilitate simultaneous evaluation and detection of enlargement of the four cardiac chambers without any time-consuming analysis.",2022,"Automated segmentation correlated strongly with manual segmentation in all chambers-the left and right ventricles, and the left and right atria (end-diastolic area:  ρ  = 0.88, 0.76, 0.92, and 0.87; end-systolic area:  ρ  = 0.81, 0.81, 0.92, and 0.83, respectively;  p  < 0.01).",[],"['Four-chamber (4CH) cine cardiovascular magnetic resonance imaging (CMR', 'deep learning based on a U-Net convolutional neural network (CNN']",[],[],"[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}]",[],1400.0,0.0536082,"Automated segmentation correlated strongly with manual segmentation in all chambers-the left and right ventricles, and the left and right atria (end-diastolic area:  ρ  = 0.88, 0.76, 0.92, and 0.87; end-systolic area:  ρ  = 0.81, 0.81, 0.92, and 0.83, respectively;  p  < 0.01).","[{'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Arai', 'Affiliation': 'Fukuokaken Saiseikai Futsukaichi Hospital, Chikushino 818-8516, Japan.'}, {'ForeName': 'Masateru', 'Initials': 'M', 'LastName': 'Kawakubo', 'Affiliation': 'Department of Health Sciences, Faculty of Medical Sciences, Kyushu University, Fukuoka 812-8582, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Sanui', 'Affiliation': 'Fukuokaken Saiseikai Futsukaichi Hospital, Chikushino 818-8516, Japan.'}, {'ForeName': 'Ryoji', 'Initials': 'R', 'LastName': 'Iwamoto', 'Affiliation': 'Fukuokaken Saiseikai Futsukaichi Hospital, Chikushino 818-8516, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nishimura', 'Affiliation': 'Fukuokaken Saiseikai Futsukaichi Hospital, Chikushino 818-8516, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Kadokami', 'Affiliation': 'Fukuokaken Saiseikai Futsukaichi Hospital, Chikushino 818-8516, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph19031401']
2066,35173154,Effects of early-life antibiotics on the developing infant gut microbiome and resistome: a randomized trial.,"Broad-spectrum antibiotics for suspected early-onset neonatal sepsis (sEONS) may have pronounced effects on gut microbiome development and selection of antimicrobial resistance when administered in the first week of life, during the assembly phase of the neonatal microbiome. Here, 147 infants born at ≥36 weeks of gestational age, requiring broad-spectrum antibiotics for treatment of sEONS in their first week of life were randomized 1:1:1 to receive three commonly prescribed intravenous antibiotic combinations, namely penicillin + gentamicin, co-amoxiclav + gentamicin or amoxicillin + cefotaxime (ZEBRA study, Trial Register NL4882). Average antibiotic treatment duration was 48 hours. A subset of 80 non-antibiotic treated infants from a healthy birth cohort served as controls (MUIS study, Trial Register NL3821). Rectal swabs and/or faeces were collected before and immediately after treatment, and at 1, 4 and 12 months of life. Microbiota were characterized by 16S rRNA-based sequencing and a panel of 31 antimicrobial resistance genes was tested using targeted qPCR. Confirmatory shotgun metagenomic sequencing was executed on a subset of samples. The overall gut microbial community composition and antimicrobial resistance gene profile majorly shift directly following treatment (R 2  = 9.5%, adjusted p-value = 0.001 and R 2  = 7.5%, adjusted p-value = 0.001, respectively) and normalize over 12 months (R 2  = 1.1%, adjusted p-value = 0.03 and R 2  = 0.6%, adjusted p-value = 0.23, respectively). We find a decreased abundance of Bifidobacterium spp. and increased abundance of Klebsiella and Enterococcus spp. in the antibiotic treated infants compared to controls. Amoxicillin + cefotaxime shows the largest effects on both microbial community composition and antimicrobial resistance gene profile, whereas penicillin + gentamicin exhibits the least effects. These data suggest that the choice of empirical antibiotics is relevant for adverse ecological side-effects.",2022,"The overall gut microbial community composition and antimicrobial resistance gene profile majorly shift directly following treatment (R 2  = 9.5%, adjusted p-value = 0.001 and R 2  = 7.5%, adjusted p-value = 0.001, respectively) and normalize over 12 months (R 2  = 1.1%, adjusted p-value = 0.03 and R 2  = 0.6%, adjusted p-value = 0.23, respectively).","['147 infants born at ≥36 weeks of gestational age, requiring broad-spectrum antibiotics for treatment of sEONS in their first week of life']","['Amoxicillin + cefotaxime', 'early-life antibiotics', 'intravenous antibiotic combinations, namely penicillin + gentamicin, co-amoxiclav + gentamicin or amoxicillin + cefotaxime']","['Rectal swabs and/or faeces', 'overall gut microbial community composition and antimicrobial resistance gene profile majorly shift directly', 'abundance of Klebsiella and Enterococcus spp', 'abundance of Bifidobacterium spp']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C1096452', 'cui_str': 'Early-onset neonatal sepsis'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0007554', 'cui_str': 'Cefotaxime'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}]","[{'cui': 'C0444215', 'cui_str': 'Rectal swab'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0022727', 'cui_str': 'Klebsiella'}, {'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]",147.0,0.0545769,"The overall gut microbial community composition and antimicrobial resistance gene profile majorly shift directly following treatment (R 2  = 9.5%, adjusted p-value = 0.001 and R 2  = 7.5%, adjusted p-value = 0.001, respectively) and normalize over 12 months (R 2  = 1.1%, adjusted p-value = 0.03 and R 2  = 0.6%, adjusted p-value = 0.23, respectively).","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Reyman', 'Affiliation': ""Department of Pediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital and University Medical Center Utrecht, Utrecht, the Netherlands.""}, {'ForeName': 'Marlies A', 'Initials': 'MA', 'LastName': 'van Houten', 'Affiliation': 'Department of Pediatrics, Spaarne Gasthuis, Hoofddorp and Haarlem, the Netherlands.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Watson', 'Affiliation': ""Medical Research Council and University of Edinburgh Centre for Inflammation Research, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Mei Ling J N', 'Initials': 'MLJN', 'LastName': 'Chu', 'Affiliation': ""Department of Pediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital and University Medical Center Utrecht, Utrecht, the Netherlands.""}, {'ForeName': 'Kayleigh', 'Initials': 'K', 'LastName': 'Arp', 'Affiliation': ""Department of Pediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital and University Medical Center Utrecht, Utrecht, the Netherlands.""}, {'ForeName': 'Wouter J', 'Initials': 'WJ', 'LastName': 'de Waal', 'Affiliation': 'Department of Pediatrics, Diakonessenhuis, Utrecht, the Netherlands.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schiering', 'Affiliation': 'Department of Pediatrics, Spaarne Gasthuis, Hoofddorp and Haarlem, the Netherlands.'}, {'ForeName': 'Frans B', 'Initials': 'FB', 'LastName': 'Plötz', 'Affiliation': 'Department of Pediatrics, Tergooiziekenhuis, Blaricum, the Netherlands.'}, {'ForeName': 'Rob J L', 'Initials': 'RJL', 'LastName': 'Willems', 'Affiliation': 'Department of Medical Microbiology, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'van Schaik', 'Affiliation': 'Institute of Microbiology and Infection, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Elisabeth A M', 'Initials': 'EAM', 'LastName': 'Sanders', 'Affiliation': ""Department of Pediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital and University Medical Center Utrecht, Utrecht, the Netherlands.""}, {'ForeName': 'Debby', 'Initials': 'D', 'LastName': 'Bogaert', 'Affiliation': ""Department of Pediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital and University Medical Center Utrecht, Utrecht, the Netherlands. d.bogaert@ed.ac.uk.""}]",Nature communications,['10.1038/s41467-022-28525-z']
2067,35174607,Effects of repeated use of a commercial topical lotion on subcutaneous fat thickness in resistance-trained male athletes.,"This study tested whether subcutaneous fat loss is enhanced via application of a popular topical fat loss lotion. Twenty resistance-trained men (mean ± SD age of 26.3 ± 6.3 years and weight of 86.8 ± 11.1 kg) had a topical fat-loss lotion containing Coleus forskholii, Silybin, Eucommia ulmoides leaf, Paullinia cupana seed, caffeine, and black pepper essential oil applied twice daily for 8 weeks to the front and lateral thigh of one of the participant's leg, and a placebo control lotion was applied to the same sites on the other leg. After 8 weeks, there were no significant differences between the placebo and treatment legs for the change in subcutaneous fat thickness of the front thigh (p = 0.73) or for leg fat percentage (p = 0.52). However, there was a slight, yet significant difference in the change in subcutaneous fat thickness of the lateral thigh favoring the treatment leg (-0.42 vs +0.75 mm, p = 0.029), but with this difference disappearing depending on the statistical tests being used. Only 2/19 participants perceived a difference in fat loss in response to each condition. Although the topical lotion tested here resulted in statistically significantly greater subcutaneous fat loss at the lateral but not front thigh, this effect was very small, contingent upon the statistical test being used, and unperceivable by the participants themselves.",2022,"After 8 weeks, there were no significant differences between the placebo and treatment legs for the change in subcutaneous fat thickness of the front thigh (P=0.73) or for leg fat percentage (P=0.52).","[""Twenty resistance-trained men (mean ±SD age of 26.3±6.3 years and weight of 86.8±11.1 kg) had a topical fat-loss lotion containing Coleus forskholii, Silybin, Eucommia ulmoides leaf, Paullinia cupana seed, caffeine and black pepper essential oil applied twice daily for 8 weeks to the front and lateral thigh of one of the participant's leg, and a"", 'resistance-trained male athletes']","['placebo', 'commercial topical lotion', 'placebo control lotion']","['leg fat percentage', 'subcutaneous fat thickness of the front thigh', 'fat loss', 'subcutaneous fat thickness of the lateral thigh favouring the treatment leg', 'subcutaneous fat thickness', 'subcutaneous fat loss']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0873094', 'cui_str': 'Coleus'}, {'cui': 'C0600334', 'cui_str': 'silybin'}, {'cui': 'C4306727', 'cui_str': 'Eucommia ulmoides leaf extract'}, {'cui': 'C3488923', 'cui_str': 'Paullinia cupana seed extract'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0162750', 'cui_str': 'Black pepper'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0991552', 'cui_str': 'Cutaneous lotion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",20.0,0.0434163,"After 8 weeks, there were no significant differences between the placebo and treatment legs for the change in subcutaneous fat thickness of the front thigh (P=0.73) or for leg fat percentage (P=0.52).","[{'ForeName': 'Jackson J', 'Initials': 'JJ', 'LastName': 'Peos', 'Affiliation': 'School of Human Sciences (Exercise and Sports Science), Faculty of Science, The University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Ong', 'Affiliation': 'School of Human Sciences (Exercise and Sports Science), Faculty of Science, The University of Western Australia, Crawley, Western Australia, Australia.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14853']
2068,35174756,"Design, methods, and baseline characteristics of the Brain Injury Education, Training, and Therapy to Enhance Recovery (BETTER) feasibility study: a transitional care intervention for younger adult patients with traumatic brain injury and caregivers.","OBJECTIVES


We developed a patient- and family-centered traumatic brain injury (TBI) transitional care intervention, called BETTER ( B rain Injury  E ducation,  T raining, and  T herapy to  E nhance  R ecovery), to improve quality of life ( via  SF-36) of younger TBI patients of different racial groups discharged home from acute hospital care and caregivers. We describe our design, methods, and baseline characteristics for our feasibility study.
METHODS


We co-developed BETTER with input from key stakeholders (TBI patients and caregivers, healthcare providers, and interdisciplinary research team members). BETTER is guided by the Individual and Family Self-Management Theory, our team's prior research, as well as literature used to support, educate, and train patients and families recovering from TBI and other conditions. The intervention is delivered by trained clinical interventionists (transitional care managers), beginning 24-72 h pre-discharge to 16 weeks post-discharge. BETTER offers tailored transitional care support to patient/family dyads, including assessing needs; establishing goals; coordinating post-hospital care, services, and resources; and providing patient/family education and training on brain injury coping skills. The majority of the intervention is delivered remotely  via  phone and remote video conferencing platform (Clinicaltrials.gov: NCT04584554).
RESULTS


We enrolled 15 dyads ( N  = 31, 15 patients, 16 caregivers) in this single arm, single center feasibility study. Most patients were men ( n  = 11, 73.33%), had a mean age of 39.07 (SD: 15.15), and were Black ( n  = 9, 60%), White ( n  = 5, 33.3%), or American Indian ( n  = 1, 0.66%). Injury severities were mild ( n  = 6, 40%), moderate ( n  = 4, 26.6%) or severe ( n  = 5, 33.33%). Most patients were insured ( n  = 10; 66.7%), had a high school education ( n  = 6; 40%); and earned $30,000 or less per year ( n  = 11; 73.3%). Most caregivers were married ( n  = 9, 56.25%) women ( n  = 14, 87.5%) with a mean age of 43.38 (SD: 10.45) and were Black ( n  = 8, 50%), White ( n  = 7, 43.75%), or American Indian ( n  = 1, 0.62%). Most caregivers identified as the spouse ( n  = 7; 43.75%) or parent ( n  = 6; 37.5%) of the patient.
CONCLUSIONS


BETTER is among the first TBI transitional care intervention to address needs/preferences for younger TBI patients of different racial groups after discharge home from acute hospital care and families. Findings can be used to inform future work.",2022,"Injury severities were mild (n = 6, 40%), moderate (n = 4, 26.6%) or severe (n = 5, 33.33%).","['younger adult patients with traumatic brain injury and caregivers', 'Most caregivers were married (n\u2009=\u20099, 56.25%) women (n\u2009=\u200914, 87.5%) with a mean age of 43.38 (SD: 10.45) and were Black (n\u2009=\u20098, 50%), White (n\u2009=\u20097, 43.75%), or Native American (n\u2009=\u20091, 0.62', 'Most patients were insured (n\u2009=\u200910; 66.7%), had a high school education (n\u2009=\u20096; 40%); and earned $30,000 or less per year (n\u2009=\u200911; 73.3', 'younger TBI patients of different racial groups discharged home from acute hospital care', 'younger TBI patients of different racial groups after discharge home from acute hospital care and families', 'Most patients were men (n\u2009=\u200911, 73.33%), had a mean age of 39.07', 'stakeholders (TBI patients and caregivers, healthcare providers, and interdisciplinary research team members', 'We enrolled 15 dyads (N\u2009=\u200931, 15 patients, 16 caregivers) in this single arm, single center feasibility study']","['transitional care intervention', 'patient/family education and training on brain injury coping skills']","['quality of life (via SF-36', 'Injury severities']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C4316843', 'cui_str': 'Multidisciplinary Research'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015730', 'cui_str': 'Feasibility Studies'}]","[{'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150577', 'cui_str': 'Education of family'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",15.0,0.155966,"Injury severities were mild (n = 6, 40%), moderate (n = 4, 26.6%) or severe (n = 5, 33.33%).","[{'ForeName': 'Tolu O', 'Initials': 'TO', 'LastName': 'Oyesanya', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'Callan', 'Initials': 'C', 'LastName': 'Loflin', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'HyunBin', 'Initials': 'H', 'LastName': 'You', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Kandel', 'Affiliation': 'Department of Physical and Occupational Therapy, Duke University Health System, Durham, NC, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': 'Department of Physical and Occupational Therapy, Duke University Health System, Durham, NC, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Strauman', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, NC, USA.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Hawes', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Byom', 'Affiliation': 'Department of Allied Health Sciences, University of North Carolina at Chapel Hill, Durham, NC, USA.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Gonzalez-Guarda', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Van Houtven', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Janet Prvu', 'Initials': 'JP', 'LastName': 'Bettger', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}]",Current medical research and opinion,['10.1080/03007995.2022.2043657']
2069,35175346,Effects of Ownership Text Message Wording and Reminders on Receipt of an Influenza Vaccination: A Randomized Clinical Trial.,"Importance


Despite the availability of safe and effective vaccines, many people fail to get vaccinated. Messages using behavioral science principles may increase vaccination rates.
Objective


To determine the effect on influenza vaccination rates of a text message telling patients that an influenza vaccine had been reserved for them.
Design, Setting, and Participants


As part of a larger influenza vaccine messaging megastudy, in this randomized clinical trial, 11 188 patients in 2 large health systems were assigned to receive a text message that stated ""a flu shot has been reserved for you,"" a text message that stated ""flu shots will be available,"" or no text message. Both messages included the option to reply yes (Y) or no (N) to indicate that the patient wanted to get vaccinated. Patients 18 years or older were included if they had new or routine (nonsick) primary care appointments scheduled from September 20, 2020, through March 31, 2021.
Interventions


The evening before the scheduled appointment, patients in the 2 message conditions were sent 3 back-to-back SMS messages containing the study wording. Patients in the usual care control group did not receive any study messages.
Main Outcomes and Measures


Receipt of an influenza vaccine on the date of the patient's scheduled appointment.
Results


A total of 11 188 patients were randomized to the reserved or the available message conditions or to usual care. The 10 158 patients analyzed in the study had a mean (SD) age of 50.61 (16.28) years; 5631 (55.43%) were women; and 7025 (69.16%) were White. According to health records, 4113 (40.49%) had been vaccinated in the previous influenza season, and 5420 (53.36%) were patients at Penn Medicine. In an intent-to-treat analysis, changes in vaccination rates in response to the reserved message did not reach statistical significance (increase of 1.4 percentage points, or 4% [P = .31]) compared with the message conveying that influenza vaccines were available. Relative to the usual care control, the reserved message increased vaccination rates by 3.3 percentage points, or 11% (P = .004). Patients in the reserved message condition were more likely to text back Y (1063 of 3375 [31.50%]) compared with those in the available message condition (887 of 3351 [26.47%]; χ2 = 20.64; P < .001), and those who replied Y were more likely to get vaccinated (1532 of 1950 [78.56%]) compared with those who did not (749 of 4776 [15.68%]; χ2 = 2400; P < .001).
Conclusions and Relevance


This study found that patients who received text messages regarding flu vaccination had greater vaccine uptake than those who received no message. Messages that increase the likelihood that patients will indicate their intention to be vaccinated may also increase vaccination behavior.
Clinical Trial Registration


ClincalTrials.gov Identifier: NCT04565353.",2022,"Patients in the reserved message condition were more likely to text back Y (1063 of 3375 [31.50%]) compared with those in the available message condition (887 of 3351 [26.47%]; χ2 = 20.64; P < .001), and those who replied Y were more likely to get vaccinated (1532 of 1950 [78.56%]) compared with those who did not (749 of 4776 [15.68%]; χ2 = 2400; P < .001).
","['A total of 11\u202f188 patients', 'Patients 18 years or older were included if they had new or routine (nonsick) primary care appointments scheduled from September 20, 2020, through March 31, 2021', 'The 10\u202f158 patients analyzed in the study had a mean (SD) age of 50.61 (16.28) years; 5631 (55.43%) were women; and 7025 (69.16%) were White', '11\u202f188 patients in 2 large health systems']","['text message that stated ""a flu shot', 'Ownership Text Message Wording and Reminders', 'influenza vaccine']","['text back Y', 'vaccination rates', 'vaccine uptake', 'influenza vaccination rates']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0003630', 'cui_str': 'Appointments and Schedules'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0029981', 'cui_str': 'Ownership'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}]",11188.0,0.134326,"Patients in the reserved message condition were more likely to text back Y (1063 of 3375 [31.50%]) compared with those in the available message condition (887 of 3351 [26.47%]; χ2 = 20.64; P < .001), and those who replied Y were more likely to get vaccinated (1532 of 1950 [78.56%]) compared with those who did not (749 of 4776 [15.68%]; χ2 = 2400; P < .001).
","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Buttenheim', 'Affiliation': 'Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Milkman', 'Affiliation': 'Department of Operations, Information and Decisions, The Wharton School, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Duckworth', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Dena M', 'Initials': 'DM', 'LastName': 'Gromet', 'Affiliation': 'Behavior Change for Good Initiative, The Wharton School, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mitesh', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Chapman', 'Affiliation': 'Department of Social and Decision Sciences, Carnegie Mellon University, Pittsburgh, Pennsylvania.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.43388']
2070,35175316,Effect of Capecitabine Maintenance Therapy Plus Best Supportive Care vs Best Supportive Care Alone on Progression-Free Survival Among Patients With Newly Diagnosed Metastatic Nasopharyngeal Carcinoma Who Had Received Induction Chemotherapy: A Phase 3 Randomized Clinical Trial.,"Importance


Capecitabine maintenance therapy improves survival outcomes in various cancer types, but data are limited on the efficacy and safety of capecitabine maintenance therapy in metastatic nasopharyngeal carcinoma (NPC).
Objective


To investigate the efficacy and safety of capecitabine maintenance therapy in metastatic NPC.
Design, Setting, and Participants


This randomized phase 3 clinical trial was conducted at Sun Yat-sen University Cancer Center from May 16, 2015, to January 9, 2020, among 104 patients with newly diagnosed metastatic NPC who had achieved disease control after 4 to 6 cycles of induction chemotherapy with paclitaxel, cisplatin, and capecitabine. The final follow-up date was May 30, 2021. All efficacy analyses were conducted in the intention-to-treat population.
Interventions


Eligible patients were randomly assigned (1:1) to receive either capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks plus best supportive care (BSC) (capecitabine maintenance group) or BSC alone after 4 to 6 cycles of induction chemotherapy.
Main Outcomes and Measures


Progression-free survival (PFS). Secondary end points were objective response rate, duration of response, overall survival, and safety.
Results


This study included 104 patients (84 men [80.8%]; median age, 47 years [IQR, 38-54 years]), with 52 assigned to the capecitabine maintenance group and 52 assigned to the BSC group. After a median follow-up of 33.8 months (IQR, 22.9-50.7 months), there were 23 events (44.2%) of progression or death in the capecitabine maintenance group and 37 events (71.2%) of progression or death in the BSC group. Median PFS survival was significantly higher in the capecitabine maintenance group (35.9 months [95% CI, 20.5 months-not reached]) than in the BSC group (8.2 months [95% CI, 6.4-10.0 months]), with a hazard ratio of 0.44 (95% CI, 0.26-0.74; P = .002). Higher objective response rates and longer median duration of response were observed in the capecitabine maintenance group (25.0%; 40.0 months) compared with the BSC group (objective response rate, 25.0% [n = 13] vs 11.5% [n = 6]; and median duration of response, 40.0 months [95% CI, not reached-not reached] vs 13.2 months [95% CI, 9.9-16.5 months]). The most common grade 3 or 4 adverse events during maintenance therapy were anemia (6 of 50 [12.0%]), hand-foot syndrome (5 of 50 [10.0%]), nausea and vomiting (3 of 50 [6.0%]), fatigue (2 of 50 [4.0%]), and mucositis (2 of 50 [4.0%]). No deaths in the maintenance group were deemed treatment-related.
Conclusions and Relevance


In this phase 3 randomized clinical trial, capecitabine maintenance therapy significantly improved PFS for patients with newly diagnosed metastatic NPC who achieved disease control after capecitabine-containing induction chemotherapy. Capecitabine exhibited manageable toxic effects.
Trial Registration


ClinicalTrials.gov Identifier: NCT02460419.",2022,"Median PFS survival was significantly higher in the capecitabine maintenance group (35.9 months [95% CI, 20.5 months-not reached]) than in the BSC group (8.2 months [95% CI, 6.4-10.0 months]), with a hazard ratio of 0.44 (95% CI, 0.26-0.74; P = .002).","['metastatic nasopharyngeal carcinoma (NPC', 'patients with newly diagnosed metastatic NPC who achieved disease control after capecitabine-containing induction chemotherapy', '104 patients (84 men [80.8%]; median age, 47 years [IQR, 38-54 years]), with 52 assigned to the capecitabine maintenance group and 52 assigned to the BSC group', 'Patients With Newly Diagnosed Metastatic Nasopharyngeal Carcinoma', 'Sun Yat-sen University Cancer Center from May 16, 2015, to January 9, 2020, among 104 patients with newly diagnosed metastatic NPC who had achieved disease control after 4 to 6 cycles of']","['BSC', 'induction chemotherapy with paclitaxel, cisplatin, and capecitabine', 'capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks plus best supportive care (BSC) (capecitabine maintenance group) or BSC alone', 'capecitabine maintenance therapy', 'Induction Chemotherapy', 'Capecitabine Maintenance Therapy Plus Best Supportive Care vs Best Supportive Care Alone', 'Capecitabine', 'Capecitabine maintenance therapy']","['progression or death', 'Progression-Free Survival', 'survival outcomes', 'Measures\n\n\nProgression-free survival (PFS', 'deaths', 'efficacy and safety', 'Median PFS survival', 'objective response rate, duration of response, overall survival, and safety', 'PFS', 'nausea and vomiting', 'mucositis', 'fatigue', 'hand-foot syndrome', 'median duration of response', 'manageable toxic effects', 'Higher objective response rates and longer median duration of response']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205250', 'cui_str': 'High'}]",104.0,0.45831,"Median PFS survival was significantly higher in the capecitabine maintenance group (35.9 months [95% CI, 20.5 months-not reached]) than in the BSC group (8.2 months [95% CI, 6.4-10.0 months]), with a hazard ratio of 0.44 (95% CI, 0.26-0.74; P = .002).","[{'ForeName': 'Guo-Ying', 'Initials': 'GY', 'LastName': 'Liu', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Wang-Zhong', 'Initials': 'WZ', 'LastName': 'Li', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'De-Shen', 'Initials': 'DS', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Yan-Fang', 'Initials': 'YF', 'LastName': 'Ye', 'Affiliation': 'Clinical Research Design Division, Sun Yat-sen Memorial Hospital, Guangzhou, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Liang-Ru', 'Initials': 'LR', 'LastName': 'Ke', 'Affiliation': 'Department of Medical Imaging, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Shu-Hui', 'Initials': 'SH', 'LastName': 'Lv', 'Affiliation': 'Medical Affairs Office, The Fifth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Nian', 'Initials': 'N', 'LastName': 'Lu', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Wei-Xin', 'Initials': 'WX', 'LastName': 'Bei', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Zhuo-Chen', 'Initials': 'ZC', 'LastName': 'Cai', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Chi-Xiong', 'Initials': 'CX', 'LastName': 'Liang', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Wei-Xiong', 'Initials': 'WX', 'LastName': 'Xia', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Yan-Qun', 'Initials': 'YQ', 'LastName': 'Xiang', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.'}]",JAMA oncology,['10.1001/jamaoncol.2021.7366']
2071,35175284,Assessment of Racial Disparity in Survival Outcomes for Early Hormone Receptor-Positive Breast Cancer After Adjusting for Insurance Status and Neighborhood Deprivation: A Post Hoc Analysis of a Randomized Clinical Trial.,"Importance


Racial disparities in survival outcomes among Black women with hormone receptor-positive breast cancer have been reported. However, the association between individual-level and neighborhood-level social determinants of health on such disparities has not been well studied.
Objective


To evaluate the association between race and clinical outcomes (ie, relapse-free interval and overall survival) adjusting for individual insurance coverage and neighborhood deprivation index (NDI), measured using zip code of residence, in women with breast cancer.
Design, Setting, and Participants


This was a post hoc analysis of 9719 women with breast cancer in the Trial Assigning Individualized Options for Treatment, a randomized clinical trial conducted from April 7, 2006, to October 6, 2010. All participants received a diagnosis of hormone receptor-positive, ERBB2-negative, axillary node-negative breast cancer. The present data analysis was conducted from April 1 to October 22, 2021.
Main Outcomes and Measures


A multivariate model was developed to evaluate the association between race and relapse-free interval and overall survival adjusting for insurance and NDI level at study entry, early discontinuation of endocrine therapy 4 years after initiation, and clinicopathologic characteristics of cancer. Median follow-up for clinical outcomes was 96 months.
Results


A total of 9719 women (4.2% [n = 405] Asian; 7.1% [n = 693] Black; 84.3% [n = 8189] White; 4.4% [n = 403] others/not specified) were included; 9.1% of included women [n = 889] were Hispanic or Latino. Median (SD) age was 56 (9.2) years. In multivariate models, Black race compared with White race was associated with statistically significant shorter relapse-free interval (hazard ratio [HR], 1.39; 95% CI, 1.05-1.84; P = .02) and overall survival (HR, 1.49; 95% CI, 1.10-2.99; P = .009), adjusting for insurance and NDI level at study entry and other factors. Although uninsured status was not associated with clinical outcomes, patients with Medicare (HR, 1.30; 95% CI, 1.01-1.68; P = .04) and Medicaid (HR, 1.44; 95% CI, 1.01-2.05; P = .05) had shorter overall survival compared with those with private insurance. Participants living in neighborhoods in the highest NDI quartile experienced shorter overall survival compared with those in the lowest quartile (HR, 1.34; 95% CI, 1.01-1.77; P = .04), regardless of self-identified race.
Conclusions and Relevance


The findings of this post hoc analysis of a randomized clinical trial suggest that Black women with breast cancer have significantly shorter relapse-free interval and overall survival compared with White women. Early discontinuation of endocrine therapy, clinicopathologic characteristics, insurance coverage, and NDI do not fully explain the observed disparity.
Trial Registration


ClinicalTrials.gov Identifier: NCT00310180.",2022,"Participants living in neighborhoods in the highest NDI quartile experienced shorter overall survival compared with those in the lowest quartile (HR, 1.34; 95% CI, 1.01-1.77; P = .04), regardless of self-identified race.
","['Early Hormone Receptor-Positive Breast Cancer', 'Black women with breast cancer', '9719 women (4.2% [n\u2009=\u2009405] Asian; 7.1% [n\u2009=\u2009693] Black; 84.3% [n\u2009=\u20098189] White; 4.4% [n\u2009=\u2009403] others/not specified) were included; 9.1% of included women [n\u2009=\u2009889] were Hispanic or Latino', '9719 women with breast cancer in the Trial Assigning Individualized Options for Treatment, a randomized clinical trial conducted from April 7, 2006, to October 6, 2010', 'women with breast cancer', 'Black women with hormone receptor-positive breast cancer']",[],"['overall survival', 'race and relapse-free interval and overall survival adjusting for insurance and NDI level at study entry, early discontinuation of endocrine therapy 4 years after initiation, and clinicopathologic characteristics of cancer', 'relapse-free interval and overall survival', 'race and clinical outcomes (ie, relapse-free interval and overall survival) adjusting for individual insurance coverage and neighborhood deprivation index (NDI']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}]",9719.0,0.72079,"Participants living in neighborhoods in the highest NDI quartile experienced shorter overall survival compared with those in the lowest quartile (HR, 1.34; 95% CI, 1.01-1.77; P = .04), regardless of self-identified race.
","[{'ForeName': 'Gelareh', 'Initials': 'G', 'LastName': 'Sadigh', 'Affiliation': 'Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'Dana Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, Massachusetts.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Department of Hematology and Oncology, The Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Yanez', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Sofia F', 'Initials': 'SF', 'LastName': 'Garcia', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Lava R', 'Initials': 'LR', 'LastName': 'Timsina', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Samilia', 'Initials': 'S', 'LastName': 'Obeng-Gyasi', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, The Ohio State University, Columbus.'}, {'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Gareen', 'Affiliation': 'Center for Statistical Sciences, Brown University, Providence, Rhode Island.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford Cancer Center Palo Alto, Stanford, California.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Whelan', 'Affiliation': 'Canadian Cancer Trials Group, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Sciences, Winston Salem, North Carolina.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'Carlos', 'Affiliation': 'University of Michigan Comprehensive Cancer Center, Ann Arbor.'}]",JAMA oncology,['10.1001/jamaoncol.2021.7656']
2072,35175622,Time to onset of cannabidiol treatment effect and resolution of adverse events in tuberous sclerosis complex: Post hoc analysis of randomized controlled phase 3 trial GWPCARE6.,"OBJECTIVE


To estimate the timing of cannabidiol (CBD) treatment effect (seizure reduction and adverse events [AEs]) onset, we conducted a post hoc analysis of GWPCARE6 (NCT02544763), a randomized, placebo-controlled, phase 3 trial in patients with drug-resistant epilepsy associated with tuberous sclerosis complex (TSC).
METHODS


Patients received plant-derived pharmaceutical formulation of highly purified CBD (Epidiolex; 100 mg/ml oral solution) at 25 mg/kg/day (CBD25) or 50 mg/kg/day (CBD50) or placebo for 16 weeks (4-week titration, 12-week maintenance). Treatment started at 5 mg/kg/day for all groups and reached 25 mg/kg/day on Day 9 and 50 mg/kg/day on Day 29. Percentage change from baseline in TSC-associated seizure (countable focal or generalized) count was calculated by cumulative day (i.e., including all previous days). Time to onset and resolution of AEs were evaluated.
RESULTS


Of 224 patients, 75 were randomized to CBD25, 73 to CBD50, and 76 to placebo. Median (range) age was 11.3 (1.1-56.8) years. Patients had discontinued a median (range) of 4 (0-15) antiseizure medications and were currently taking 3 (0-5). Difference in seizure reduction between CBD and placebo emerged on Day 6 (titrated dose, 15 mg/kg/day) and became nominally significant (p < .049) by Day 10. Separation between placebo and CBD in ≥50% responder rate also emerged by Day 10. Onset of AEs occurred during the first 2 weeks of the titration period in 61% of patients (CBD25, 61%; CBD50, 67%; placebo, 54%). In patients with an AE, resolution occurred within 4 weeks of onset in 42% of placebo and 27% of CBD patients and by end of trial in 78% of placebo and 51% of CBD patients.
SIGNIFICANCE


Onset of treatment effect occurred within 6-10 days. AEs lasted longer for CBD than placebo, but the most common (diarrhea, decreased appetite, and somnolence) resolved during the 16-week trial in most patients.",2022,"AEs lasted longer for CBD than placebo but the most common (diarrhea, decreased appetite, and somnolence) resolved during the 16-week trial in most patients.","['Median (range) age was 11.3 (1.1-56.8) years', 'patients with drug-resistant epilepsy associated with tuberous sclerosis complex (TSC', 'Of 224 patients', 'Patients had discontinued a median (range) of 4 (0-15) antiseizure medications and were currently taking 3 (0-5', 'Patients received', 'Tuberous Sclerosis Complex']","['cannabidiol (CBD', 'placebo', 'plant-derived pharmaceutical formulation of highly purified CBD (Epidiolex ®  ; 100 mg/mL oral solution', 'placebo and CBD']","['appetite, and somnolence', 'Time to Onset of Cannabidiol (CBD) Treatment Effect and Resolution of Adverse Events', 'Onset of AEs', 'seizure reduction', 'Time to onset and resolution of AEs']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0041341', 'cui_str': 'Tuberous sclerosis syndrome'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4731581', 'cui_str': 'Epidiolex'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",224.0,0.346379,"AEs lasted longer for CBD than placebo but the most common (diarrhea, decreased appetite, and somnolence) resolved during the 16-week trial in most patients.","[{'ForeName': 'Joyce Y', 'Initials': 'JY', 'LastName': 'Wu', 'Affiliation': ""Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.""}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Cock', 'Affiliation': ""St George's University Hospitals National Health Service Foundation Trust, St George's University of London, London, UK.""}, {'ForeName': 'Orrin', 'Initials': 'O', 'LastName': 'Devinsky', 'Affiliation': 'Comprehensive Epilepsy Center, NYU Langone Health, New York, New York, USA.'}, {'ForeName': 'Charuta', 'Initials': 'C', 'LastName': 'Joshi', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Miller', 'Affiliation': ""Nicklaus Children's Hospital, Miami, Florida, USA.""}, {'ForeName': 'Colin M', 'Initials': 'CM', 'LastName': 'Roberts', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Sanchez-Carpintero', 'Affiliation': 'University of Navarra Clinic, Pamplona, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Checketts', 'Affiliation': 'GW Research, Cambridge, UK.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Sahebkar', 'Affiliation': 'Greenwich Biosciences, Carlsbad, California, USA.'}]",Epilepsia,['10.1111/epi.17199']
2073,34879312,Responsiveness of an activity tracker as a measurement tool in a knee osteoarthritis clinical trial (ACTIVe-OA study).,"BACKGROUND


In osteoarthritis (OA) clinical trials, reliable and responsive outcome measures to document physical and functional improvements are limited.
OBJECTIVE


This study aimed to assess whether the use of an activity tracker in an OA clinical trial is a responsive measurement tool. Secondary objectives assessed feasibility and validity.
METHODS


We recruited 65 participants in a prospective cohort study nested in a placebo-controlled clinical trial of platelet-rich plasma injection in knee OA. Participants wore an activity tracker (Fitbit Flex 2), and a smartphone was preloaded with a mobile application (OApp) designed to monitor load rates as a surrogate of knee loading. Participants used the systems for 7 days at baseline and for 7 days before the 2-month follow-up assessment. Effect size (ES) and standardised response mean (SRM) were calculated for change in step count and knee loading rate and regularly used knee OA outcome measures. Correlation coefficients (r) were calculated to examine the strength of the association between outcome measures.
RESULTS


. Step count showed a trivial ES and SRM and mean knee loading rate measurements a moderate ES and SRM. We found a weak but significant correlation between change in mean steps per day and global improvement overall (r= 0.28) and Western Ontario and McMaster Universities Osteoarthritis Index function (r = -0.28). Compliance was high with the activity trackers.
CONCLUSIONS


Despite good feasibility, this study did not show significant responsiveness or validity of the activity trackers as compared with currently recommended outcome measures in OA clinical trials. The main challenge is the lack of a gold standard outcome measure to validate against, and because of the complex interplay between pain and measured function, a lack of correlation does not necessarily represent a failed validation in this context.
AUSTRALIAN NEW ZEALAND CLINICAL TRIALS REGISTRY


ACTRN12617000853347. This trial is a substudy of the ""Platelet-rich plasma as a symptom-and disease-modifying treatment for knee osteoarthritis - the RESTORE trial"".",2022,Effect size (ES) and standardised response mean (SRM) were calculated for change in step count and knee loading rate and regularly used knee OA outcome measures.,['65 participants in a prospective cohort study nested in a'],"['placebo', 'activity tracker (Fitbit Flex 2), and a smartphone was preloaded with a mobile application (OApp', 'platelet-rich plasma injection', 'activity tracker']","['mean steps per day and global improvement overall (r=\xa00.28) and Western Ontario and McMaster Universities Osteoarthritis Index function', 'feasibility and validity', 'trivial ES and SRM and mean knee loading rate measurements', 'Effect size (ES) and standardised response mean (SRM']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4517445', 'cui_str': '0.28'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0201785', 'cui_str': 'Rate measurement'}]",65.0,0.188873,Effect size (ES) and standardised response mean (SRM) were calculated for change in step count and knee loading rate and regularly used knee OA outcome measures.,"[{'ForeName': 'Shirley P', 'Initials': 'SP', 'LastName': 'Yu', 'Affiliation': 'Department of Rheumatology, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, NSW, Australia. Electronic address: shirleyyu@uni.sydney.edu.au.'}, {'ForeName': 'Manuela L', 'Initials': 'ML', 'LastName': 'Ferreira', 'Affiliation': 'Department of Rheumatology, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Duong', 'Affiliation': 'Department of Rheumatology, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Caroupapoullé', 'Affiliation': 'Faculty of Engineering and Physical Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Nigel K', 'Initials': 'NK', 'LastName': 'Arden', 'Affiliation': 'Centre for Sport, Exercise and Osteoarthritis Versus Arthritis, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom; MRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Department of Rheumatology, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, NSW, Australia.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2021.101619']
2074,34878412,Comparison of a Nasal Mask and Traditional Nasal Cannula During Intravenous Anesthesia for Gastroscopy Procedures: A Randomized Controlled Trial.,"BACKGROUND


Hypoxemia can occur during gastroscopy under intravenous anesthesia. The aim of this randomized controlled trial was to evaluate whether oxygenation using a nasal mask can reduce the incidence of hypoxemia during gastroscopy under intravenous anesthesia compared with a traditional nasal cannula.
METHODS


A total of 574 patients scheduled for gastroscopy under intravenous anesthesia were enrolled and randomly assigned to receive either a nasal mask or a traditional nasal cannula for oxygenation. The primary outcome was the incidence of hypoxemia. The secondary outcomes included the incidence of severe hypoxemia, duration of hypoxemia, minimum oxygen saturation, the proportion of emergency airway management, length of procedure, recovery time, and the satisfaction of the anesthetist and gastroenterologists as well as other adverse events (including cough, hiccups, nausea and vomiting, reflux, aspiration, and laryngospasm).
RESULTS


A total of 565 patients were included in the analysis: 282 patients in the nasal cannula group and 283 patients in the nasal mask group. The incidence of hypoxemia was lower in the nasal mask group (18.0%) than in the nasal cannula group (27.7%; relative risk [RR] = 0.65; 95% confidence interval [CI], 0.48-0.89; P = .006), and the hypoxemia lasted a median of 18.0 seconds (interquartile range, 10.0-38.8) in the nasal mask group and 32.5 seconds (20.0-53.5) in the nasal cannula group (median difference -14.50; 95% CI, -22.82 to -1.34; P = .047). The proportion of patients requiring emergency airway management was significantly lower in the nasal mask group (8.8%) than in the nasal cannula group (19.1%; RR, 0.46; 95% CI, 0.30-0.73; P < .001). No difference was found in the overall incidence of other adverse events between the 2 groups (nasal mask 20.8%; nasal cannula 17.0%; RR, 1.23; 95% CI, 0.87-1.73; P = .25). Satisfaction was higher with the nasal mask than with the nasal cannula from the perspective of anesthetists (96.1% for nasal mask versus 84.4% for nasal cannula; RR, 1.14; 95% CI, 1.08-1.20; P < .001) and gastroenterologists (95.4% for mask versus 81.9% for cannula; RR, 1.17; 95% CI, 1.10-1.24; P < .001). There were no significant differences in the incidence of severe hypoxemia, minimum oxygen saturation, length of procedure, or recovery time between the 2 groups.
CONCLUSIONS


Nasal mask oxygenation reduced the incidence of hypoxemia during anesthesia for gastroscopy under intravenous anesthesia.",2022,"There were no significant differences in the incidence of severe hypoxemia, minimum oxygen saturation, length of procedure, or recovery time between the 2 groups.
","['565 patients were included in the analysis: 282 patients in the nasal cannula group and 283 patients in the nasal mask group', '574 patients scheduled for gastroscopy under intravenous anesthesia']","['nasal mask or a traditional nasal cannula for oxygenation', 'Nasal Mask and Traditional Nasal Cannula', 'Nasal mask oxygenation']","['hypoxemia', 'proportion of patients requiring emergency airway management', 'incidence of severe hypoxemia, duration of hypoxemia, minimum oxygen saturation, the proportion of emergency airway management, length of procedure, recovery time, and the satisfaction of the anesthetist and gastroenterologists as well as other adverse events (including cough, hiccups, nausea and vomiting, reflux, aspiration, and laryngospasm', 'gastroenterologists', 'incidence of severe hypoxemia, minimum oxygen saturation, length of procedure, or recovery time', 'incidence of hypoxemia', 'overall incidence of other adverse events', 'Satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C2711254', 'cui_str': 'Nasal mask'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}]","[{'cui': 'C2711254', 'cui_str': 'Nasal mask'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]","[{'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C1299418', 'cui_str': 'Length of procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0259901', 'cui_str': 'Gastroenterologist'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0019521', 'cui_str': 'Hiccoughs'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0023066', 'cui_str': 'Laryngeal spasm'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",574.0,0.237538,"There were no significant differences in the incidence of severe hypoxemia, minimum oxygen saturation, length of procedure, or recovery time between the 2 groups.
","[{'ForeName': 'Dong Xu', 'Initials': 'DX', 'LastName': 'Chen', 'Affiliation': 'From the Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'From the Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xi Ping', 'Initials': 'XP', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, People's Hospital of Ningxia Hui Autonomous Region, Ningxia, China.""}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Niu', 'Affiliation': 'From the Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'From the Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Huo Lin', 'Initials': 'HL', 'LastName': 'Zeng', 'Affiliation': 'From the Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'From the Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005828']
2075,35176046,Health promotion intervention to prevent risk factors of chronic diseases: Protocol for a cluster randomized controlled trial among adolescents in school settings of Chandigarh (India).,"BACKGROUND


Chronic diseases like diabetes, cardiovascular diseases and cancers are on the rise. Most of the risk factors of these diseases commence in Adolescence. Therefore, a cluster randomised controlled trial is designed to evaluate the effect of school-based health promotion intervention on the risk factors of chronic diseases.
METHODOLOGY


Considering school as a cluster, twelve schools will be randomly selected from the public schools of Chandigarh, a city in India. After baseline assessment, six schools will be randomly allocated to intervention and six to the control arm. Study participants will be students of 8th grade (age 10-16 years), their parents and teachers. A sample of 360 students (12 clusters x 30 students) has been estimated to provide statistically valid inference. The PRECEDE PROCEED Model will be used to develop health promotion interventions to prevent the use of an unbalanced diet, physical inactivity, alcohol, and tobacco. Interventions will be implemented for six-months in the school setting. For students, the intervention will comprise interactive learning sessions of 30 minutes duration per week and physical activity sessions of 30 minutes duration four times every week. Educational sessions will be conducted for parents and teachers for 30 minutes, four times during the intervention period. Primary outcomes will be changes in the prevalence of behavioural risk factors from pre- to post-intervention. Changes in anthropometric, physiological, and biochemical measures will be the secondary outcomes. The difference-in-difference (DID) method will be used to measure the net change in the outcomes.
DISCUSSION


It is essential to understand whether health promotion interventions implemented in the school setting simultaneously targeting adolescents, teachers, and parents are effective. Using the PRECEDE-PROCEED model for planning, implementing, and evaluating the intervention as part of a cluster Randomized Controlled Trial design with DID analysis, could objectively assess the impact.",2022,"The PRECEDE PROCEED Model will be used to develop health promotion interventions to prevent the use of an unbalanced diet, physical inactivity, alcohol, and tobacco.","['adolescents in school settings of Chandigarh (India', '360 students (12 clusters x 30 students', 'Study participants will be students of 8th grade (age 10-16 years), their parents and teachers', 'Considering school as a cluster, twelve schools will be randomly selected from the public schools of Chandigarh, a city in India']","['school-based health promotion intervention', 'Health promotion intervention']",['prevalence of behavioural risk factors'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",360.0,0.0258855,"The PRECEDE PROCEED Model will be used to develop health promotion interventions to prevent the use of an unbalanced diet, physical inactivity, alcohol, and tobacco.","[{'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Department of Community Medicine and School of Public Health, Post-Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Manmeet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Department of Community Medicine and School of Public Health, Post-Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Community Medicine and School of Public Health, Post-Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",PloS one,['10.1371/journal.pone.0263584']
2076,35176038,Evocalcet with vitamin D receptor activator treatment for secondary hyperparathyroidism.,"This ad hoc analysis of a previously conducted phase 3 head-to-head comparison study of evocalcet and cinacalcet in secondary hyperparathyroidism patients undergoing maintenance hemodialysis evaluated the efficacy and safety of combined once-daily oral evocalcet and intravenous vitamin D receptor activator treatment stratified by weekly vitamin D receptor activator dose (117, 45, and 91 patients in no, low [< 1.5 μg], and high [≥ 1.5 μg] dose groups, respectively). Effects of vitamin D receptor activator were assessed on the basis of intact parathyroid hormone, corrected calcium, phosphorus, and fibroblast growth factor-23 levels; percent changes from baseline; proportions of patients who achieved target intact parathyroid hormone, corrected calcium, and phosphorus at Weeks 28-30; and adverse drug reactions. Intact parathyroid hormone, corrected calcium, phosphorus, and fibroblast growth factor-23 levels decreased in all groups; phosphorus and fibroblast growth factor-23 levels remained high in the high dose group. In the low and high dose groups, greater proportions of patients achieved the corrected calcium target compared with the no dose group (p = 0.043). Ratios of intact-to-C-terminal fibroblast growth factor-23 decreased in all groups. In low and high dose groups, hypocalcemia was less common than in the no dose group (p = 0.014). Evocalcet with concomitant vitamin D receptor activator demonstrated benefits such that more patients achieved the corrected calcium target and exhibited decreased fibroblast growth factor-23 synthesis; the incidence of hypocalcemia also decreased. Clinical trial registration: ClinicalTrials.gov (NCT02549391) and JAPIC (JapicCTI-153013).",2022,"Intact parathyroid hormone, corrected calcium, phosphorus, and fibroblast growth factor-23 levels decreased in all groups; phosphorus and fibroblast growth factor-23 levels remained high in the high dose group.","['secondary hyperparathyroidism patients undergoing maintenance hemodialysis', 'secondary hyperparathyroidism']","['combined once-daily oral evocalcet and intravenous vitamin D receptor activator', 'vitamin D receptor activator', 'concomitant vitamin D receptor activator']","['Ratios of intact-to-C-terminal fibroblast growth factor-23', 'Intact parathyroid hormone, corrected calcium, phosphorus, and fibroblast growth factor-23 levels', 'hypocalcemia', 'intact parathyroid hormone, corrected calcium, phosphorus, and fibroblast growth factor-23 levels', 'phosphorus and fibroblast growth factor-23 levels', 'adverse drug reactions']","[{'cui': 'C0020503', 'cui_str': 'Secondary hyperparathyroidism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4519114', 'cui_str': 'evocalcet'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0108082', 'cui_str': 'Vitamin D3 Receptor'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1829744', 'cui_str': 'Fibroblast growth factor 23, C-terminal'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C2732404', 'cui_str': 'Corrected measurement of calcium'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}]",,0.0456614,"Intact parathyroid hormone, corrected calcium, phosphorus, and fibroblast growth factor-23 levels decreased in all groups; phosphorus and fibroblast growth factor-23 levels remained high in the high dose group.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shigematsu', 'Affiliation': 'Department of Nephrology, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Asada', 'Affiliation': 'Medical Affairs Department, Kyowa Kirin Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Endo', 'Affiliation': 'R&D Division, Kyowa Kirin Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takehisa', 'Initials': 'T', 'LastName': 'Kawata', 'Affiliation': 'Medical Affairs Department, Kyowa Kirin Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Fukagawa', 'Affiliation': 'Division of Nephrology, Endocrinology, and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}]",PloS one,['10.1371/journal.pone.0262829']
2077,35176037,Effectiveness of erectogenic condom against semen exposure among women in Vietnam: Randomized controlled trial.,"A key barrier to the consistent use of condoms is their negative effect on sexual pleasure. Although sexual pleasure is a primary motivation for engaging in sex and is an integral part of overall sexual health, most programs to improve sexual health operate within a pregnancy and disease-prevention paradigm. A new condom, CSD500 (Futura Medical Developments; Surrey, UK), containing an erectogenic drug was developed for use among healthy couples to improve sexual pleasure by increasing penile firmness, size and erection duration. We conducted a randomized controlled trial to test whether promoting the novel condom CSD500 for improved sexual pleasure is effective in reducing condomless sex compared to the provision of standard condoms with counseling for pregnancy and disease prevention. We randomized 500 adult, heterosexual, monogamous couples in Thanh Hoa province, Vietnam to receive either CSD500 (n = 248) or standard condoms (n = 252). At enrollment and after 2, 4, and 6 months, we interviewed women and sampled vaginal fluid to test for the presence of prostate-specific antigen (PSA), an objective, biological marker of recent semen exposure. We registered the protocol before trial initiation at ClinicalTrials.gov (identifier: NCT02934620). Overall, 11.0% of women were PSA positive at enrollment. The proportion of follow-up visits with PSA-positivity did not differ between the intervention (6.8%) and control arms (6.7%; relative risk, 1.01; 95% confidence interval, 0.66-1.54). Thus, we found no evidence that promoting an erectogenic condom to women in a monogamous, heterosexual relationship in Vietnam reduced their exposure to their partner's semen. These findings might not hold for other populations, especially those with a higher frequency of condomless sex.",2022,"The proportion of follow-up visits with PSA-positivity did not differ between the intervention (6.8%) and control arms (6.7%; relative risk, 1.01; 95% confidence interval, 0.66-1.54).","['women in Vietnam', 'n = 248) or standard condoms (n = 252', 'healthy couples', '500 adult, heterosexual, monogamous couples in Thanh Hoa province, Vietnam to receive either']","['erectogenic condom', 'CSD500', 'novel condom CSD500']",['proportion of follow-up visits with PSA-positivity'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0558125', 'cui_str': 'Monogamous'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}]",500.0,0.153982,"The proportion of follow-up visits with PSA-positivity did not differ between the intervention (6.8%) and control arms (6.7%; relative risk, 1.01; 95% confidence interval, 0.66-1.54).","[{'ForeName': 'Nghia C', 'Initials': 'NC', 'LastName': 'Nguyen', 'Affiliation': 'Department of Obstetrics and Gynecology, Vinmec International Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Truong N', 'Initials': 'TN', 'LastName': 'Luong', 'Affiliation': 'Thanh Hoa Center for Disease Prevention and Control, Thanh Hoa City, Vietnam.'}, {'ForeName': 'Van T', 'Initials': 'VT', 'LastName': 'Le', 'Affiliation': 'Thanh Hoa Center for Disease Prevention and Control, Thanh Hoa City, Vietnam.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Hobbs', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Andridge', 'Affiliation': 'Division of Biostatistics, College of Public Health, Ohio State University, Columbus, Ohio, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Casterline', 'Affiliation': 'Department of Sociology, College of Arts and Sciences, Ohio State University, Columbus, Ohio, United States of America.'}, {'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Gallo', 'Affiliation': 'Division of Epidemiology, College of Public Health, Ohio State University, Columbus, Ohio, United States of America.'}]",PloS one,['10.1371/journal.pone.0263503']
2078,35157777,How does baseline anthropometry affect anthropometric outcomes in children receiving treatment for severe acute malnutrition? A secondary analysis of a randomized controlled trial.,"Mid-upper arm circumference (MUAC) < 11.5 cm and weight-for-height Z-score (WHZ) < -3 are used for screening for severe acute malnutrition (SAM). Underweight and concurrent wasting and stunting may better target those at the highest risk of mortality. We compared anthropometric outcomes in children enrolled in a trial of antibiotics for SAM based on categories of baseline anthropometry, including indicators for programme admission (WHZ < -3, MUAC < 11.5) and alternative indicators (weight-for-age Z-score [WAZ] < -3, concurrent wasting and stunting [WHZ < -3 and height-for-age Z-score < -3]). Participants were followed weekly until nutritional recovery and at 8 weeks. We evaluated changes in weight gain (g/kg/day), MUAC, and WHZ in children admitted by admissions criteria (MUAC only, WHZ only, or MUAC and WHZ) and by underweight or concurrent wasting and stunting. Of 301 admitted children, 100 (33%) were admitted based on MUAC only, 41 (14%) WHZ only, and 160 (53%) both MUAC and WHZ, 210 (68%) were underweight and 67 (22%) were concurrently wasted/stunted. Low MUAC and low WHZ children had the lowest probability of nutritional recovery (17% vs. 50% for MUAC-only and 34% for WHZ-only). There was no difference in weight gain velocity or WHZ by admissions criteria (WHZ and/or MUAC). Underweight and concurrently wasted/stunted children had lower MUAC and WHZ at 8 weeks compared with those who were not underweight or concurrently wasted and stunted. Children with both low MUAC and low WHZ had the worst outcomes. Relying on MUAC alone may miss children who have poor outcomes. Other indicators, such as WAZ, may be useful for identifying vulnerable children.",2022,There was no difference in weight gain velocity or WHZ by admissions criteria (WHZ and/or MUAC).,"['children receiving treatment for severe acute malnutrition', '301 admitted children, 100 (33%) were admitted based on MUAC only, 41 (14%) WHZ only, and 160 (53%) both MUAC and WHZ, 210 (68%) were underweight and 67 (22%) were concurrently wasted/stunted', 'children admitted by admissions criteria (MUAC only, WHZ only, or MUAC and WHZ) and by underweight or concurrent wasting and stunting', 'children enrolled in a trial of antibiotics for SAM based on categories of baseline anthropometry, including indicators for programme admission (WHZ\u2009<\u2009-3, MUAC\u2009<\u200911.5) and alternative indicators (weight-for-age Z-score\xa0[WAZ]\u2009<\u2009-3, concurrent wasting and stunting [WHZ\u2009<\u2009-3 and height-for-age Z-score\u2009<\u2009-3']",['MUAC'],"['nutritional recovery', 'weight gain', 'Mid-upper arm circumference (MUAC', 'weight gain velocity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]","[{'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",301.0,0.145831,There was no difference in weight gain velocity or WHZ by admissions criteria (WHZ and/or MUAC).,"[{'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dah', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Millogo', 'Initials': 'M', 'LastName': 'Ourohire', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Moussa', 'Initials': 'M', 'LastName': 'Ouédraogo', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Mamadou', 'Initials': 'M', 'LastName': 'Bountogo', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Boudo', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}, {'ForeName': 'Fanice', 'Initials': 'F', 'LastName': 'Nyatigo', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}, {'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California, USA.'}]",Maternal & child nutrition,['10.1111/mcn.13329']
2079,35157727,Monetary incentives and peer referral in promoting secondary distribution of HIV self-testing among men who have sex with men in China: A randomized controlled trial.,"BACKGROUND


Digital network-based methods may enhance peer distribution of HIV self-testing (HIVST) kits, but interventions that can optimize this approach are needed. We aimed to assess whether monetary incentives and peer referral could improve a secondary distribution program for HIVST among men who have sex with men (MSM) in China.
METHODS AND FINDINGS


Between October 21, 2019 and September 14, 2020, a 3-arm randomized controlled, single-blinded trial was conducted online among 309 individuals (defined as index participants) who were assigned male at birth, aged 18 years or older, ever had male-to-male sex, willing to order HIVST kits online, and consented to take surveys online. We randomly assigned index participants into one of the 3 arms: (1) standard secondary distribution (control) group (n = 102); (2) secondary distribution with monetary incentives (SD-M) group (n = 103); and (3) secondary distribution with monetary incentives plus peer referral (SD-M-PR) group (n = 104). Index participants in 3 groups were encouraged to order HIVST kits online and distribute to members within their social networks. Members who received kits directly from index participants or through peer referral links from index MSM were defined as alters. Index participants in the 2 intervention groups could receive a fixed incentive ($3 USD) online for the verified test result uploaded to the digital platform by each unique alter. Index participants in the SD-M-PR group could additionally have a personalized peer referral link for alters to order kits online. Both index participants and alters needed to pay a refundable deposit ($15 USD) for ordering a kit. All index participants were assigned an online 3-month follow-up survey after ordering kits. The primary outcomes were the mean number of alters motivated by index participants in each arm and the mean number of newly tested alters motivated by index participants in each arm. These were assessed using zero-inflated negative binomial regression to determine the group differences in the mean number of alters and the mean number of newly tested alters motivated by index participants. Analyses were performed on an intention-to-treat basis. We also conducted an economic evaluation using microcosting from a health provider perspective with a 3-month time horizon. The mean number of unique tested alters motivated by index participants was 0.57 ± 0.96 (mean ± standard deviation [SD]) in the control group, compared with 0.98 ± 1.38 in the SD-M group (mean difference [MD] = 0.41),and 1.78 ± 2.05 in the SD-M-PR group (MD = 1.21). The mean number of newly tested alters motivated by index participants was 0.16 ± 0.39 (mean ± SD) in the control group, compared with 0.41 ± 0.73 in the SD-M group (MD = 0.25) and 0.57 ± 0.91 in the SD-M-PR group (MD = 0.41), respectively. Results indicated that index participants in intervention arms were more likely to motivate unique tested alters (control versus SD-M: incidence rate ratio [IRR = 2.98, 95% CI = 1.82 to 4.89, p-value < 0.001; control versus SD-M-PR: IRR = 3.26, 95% CI = 2.29 to 4.63, p-value < 0.001) and newly tested alters (control versus SD-M: IRR = 4.22, 95% CI = 1.93 to 9.23, p-value < 0.001; control versus SD-M-PR: IRR = 3.49, 95% CI = 1.92 to 6.37, p-value < 0.001) to conduct HIVST. The proportion of newly tested testers among alters was 28% in the control group, 42% in the SD-M group, and 32% in the SD-M-PR group. A total of 18 testers (3 index participants and 15 alters) tested as HIV positive, and the HIV reactive rates for alters were similar between the 3 groups. The total costs were $19,485.97 for 794 testers, including 450 index participants and 344 alter testers. Overall, the average cost per tester was $24.54, and the average cost per alter tester was $56.65. Monetary incentives alone (SD-M group) were more cost-effective than monetary incentives with peer referral (SD-M-PR group) on average in terms of alters tested and newly tested alters, despite SD-M-PR having larger effects. Compared to the control group, the cost for one more alter tester in the SD-M group was $14.90 and $16.61 in the SD-M-PR group. For newly tested alters, the cost of one more alter in the SD-M group was $24.65 and $49.07 in the SD-M-PR group. No study-related adverse events were reported during the study. Limitations include the digital network approach might neglect individuals who lack internet access.
CONCLUSIONS


Monetary incentives alone and the combined intervention of monetary incentives and peer referral can promote the secondary distribution of HIVST among MSM. Monetary incentives can also expand HIV testing by encouraging first-time testing through secondary distribution by MSM. This social network-based digital approach can be expanded to other public health research, especially in the era of the Coronavirus Disease 2019 (COVID-19).
TRIAL REGISTRATION


Chinese Clinical Trial Registry (ChiCTR) ChiCTR1900025433.",2022,No study-related adverse events were reported during the study.,"['men who have sex with men (MSM) in China', 'men who have sex with men in China', '309 individuals (defined as index participants) who were assigned male at birth, aged 18 years or older, ever had male-to-male sex, willing to order HIVST kits online, and consented to take surveys online', 'Between October 21, 2019 and September 14, 2020']","['standard secondary distribution (control) group (n = 102); (2) secondary distribution with monetary incentives (SD-M) group (n = 103); and (3) secondary distribution with monetary incentives plus peer referral (SD-M-PR', 'fixed incentive ($3 USD) online for the verified test result uploaded to the digital platform']","['HIV positive, and the HIV reactive rates', 'mean number of alters motivated by index participants in each arm and the mean number of newly tested alters motivated', 'average cost per alter tester', 'cost-effective', 'average cost per tester', 'total costs', 'adverse events']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}]","[{'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0183885', 'cui_str': 'Tester'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.425592,No study-related adverse events were reported during the study.,"[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Zhuhai Center for Disease Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Dermatology Hospital of South Medical University, Guangzhou, China.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'Dermatology Hospital of South Medical University, Guangzhou, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'University of North Carolina at Chapel Hill Project-China, Guangzhou, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Zhuhai Xutong Voluntary Services Center, Zhuhai, China.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Ong', 'Affiliation': 'University of North Carolina at Chapel Hill Project-China, Guangzhou, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina at Chapel Hill Project-China, Guangzhou, China.'}, {'ForeName': 'Sean Y', 'Initials': 'SY', 'LastName': 'Sylvia', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Fengshi', 'Initials': 'F', 'LastName': 'Jing', 'Affiliation': 'University of North Carolina at Chapel Hill Project-China, Guangzhou, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Zhuhai Center for Disease Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Shanzi', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Zhuhai Center for Disease Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Guangquan', 'Initials': 'G', 'LastName': 'Shen', 'Affiliation': 'Dermatology Hospital of South Medical University, Guangzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Dermatology Hospital of South Medical University, Guangzhou, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Dermatology Hospital of South Medical University, Guangzhou, China.'}, {'ForeName': 'Yongjie', 'Initials': 'Y', 'LastName': 'Sha', 'Affiliation': 'Dermatology Hospital of South Medical University, Guangzhou, China.'}, {'ForeName': 'Mengyuan', 'Initials': 'M', 'LastName': 'Cheng', 'Affiliation': 'Dermatology Hospital of South Medical University, Guangzhou, China.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Peking University Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Wencan', 'Initials': 'W', 'LastName': 'Dai', 'Affiliation': 'Zhuhai Center for Disease Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Zhuhai Center for Disease Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zou', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Dermatology Hospital of South Medical University, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of South Medical University, Guangzhou, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Mei', 'Affiliation': 'Zhuhai Center for Disease Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Dermatology Hospital of South Medical University, Guangzhou, China.'}]",PLoS medicine,['10.1371/journal.pmed.1003928']
2080,35162263,Efficacy of Breast Milk Olfactory and Gustatory Interventions on Neonates' Biobehavioral Responses to Pain during Heel Prick Procedures.,"This study aimed to evaluate the efficacy of breast milk odor either alone or in combination with breast milk taste (via syringe-feeding) to alleviate neonates' biobehavioral responses to pain during heel-prick procedures. This prospective randomized controlled trial recruited 114 neonates by convenience sampling from a newborn unit of a medical center in Taiwan. Neonates were randomly assigned to three groups: control (gentle touch + human voice), control + breast milk odor, and control + breast milk odor + breast milk taste. Heart rate, oxygen saturation, and voice recordings of crying were measured across heel-prick procedures: baseline, no stimuli (stage 0); during heel prick (Stages 1-4); and recovery (Stages 5-10). Generalized estimating equations and Kaplan-Meier survival analysis compared differences in changes between groups for heart rate, oxygen saturation, and time to crying cessation. Changes in mean heart rate and oxygen saturation in neonates receiving breast milk odor or breast milk odor + breast milk taste were significantly less than those at the corresponding stage for the control group. Among neonates receiving breast milk odor or breast milk odor + breast milk taste, hazard rate ratios for crying cessation were 3.016 and 6.466, respectively. Mother's breast milk olfactory and gustatory interventions could stabilize the biobehavioral responses to pain during heel prick procedures in neonates.",2022,"Generalized estimating equations and Kaplan-Meier survival analysis compared differences in changes between groups for heart rate, oxygen saturation, and time to crying cessation.","[""Neonates' Biobehavioral Responses to Pain during Heel Prick Procedures"", 'pain during heel-prick procedures', '114 neonates by convenience sampling from a newborn unit of a medical center in Taiwan', 'neonates']","['control (gentle touch + human voice), control + breast milk odor, and control + breast milk odor + breast milk taste', 'breast milk odor either alone or in combination with breast milk taste (via syringe-feeding', 'Breast Milk Olfactory and Gustatory Interventions']","['hazard rate ratios for crying cessation', 'mean heart rate and oxygen saturation', 'Heart rate, oxygen saturation, and voice recordings of crying', 'heart rate, oxygen saturation, and time to crying cessation']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0439678', 'cui_str': 'Gustatory'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",114.0,0.0327541,"Generalized estimating equations and Kaplan-Meier survival analysis compared differences in changes between groups for heart rate, oxygen saturation, and time to crying cessation.","[{'ForeName': 'Chiao-Hsuan', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Tri-Service General Hospital, Taipei 11490, Taiwan.'}, {'ForeName': 'Jen-Jiuan', 'Initials': 'JJ', 'LastName': 'Liaw', 'Affiliation': 'School of Nursing, National Defense Medical Center, Taipei 11490, Taiwan.'}, {'ForeName': 'Yu-Ting', 'Initials': 'YT', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Medical Sciences, National Defense Medical Center, Taipei 11490, Taiwan.'}, {'ForeName': 'Ti', 'Initials': 'T', 'LastName': 'Yin', 'Affiliation': 'Department of Nursing, Tri-Service General Hospital, Taipei 11490, Taiwan.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Social Work, Hsuan Chuang University, Taipei 30092, Taiwan.'}, {'ForeName': 'Hsiang-Yun', 'Initials': 'HY', 'LastName': 'Lan', 'Affiliation': 'School of Nursing, National Defense Medical Center, Taipei 11490, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph19031240']
2081,35162197,The UP150: A Multifactorial Environmental Intervention to Promote Employee Physical and Mental Well-Being.,"Physical activity (PA) is a major health factor and studies suggest workplaces could promote PA by modifying office design, motivational strategies and technology. The present study aims to evaluate the efficiency of UP150, a multifactorial workplace intervention for the improvement and maintenance of the level of physical fitness (PF) and wellbeing. Forty-five employees were randomly divided into the experimental (EG) and control (CG) groups. The PF was assessed pre-post intervention using the  cubo fitness test  (CFT), the amount of PA was evaluated using the IPAQ questionnaire and accelerometers while the workload was assessed using the NASA-TLX questionnaire and psycho-physical health by using the SF-12 questionnaire. The EG worked in UP150 offices while the CG worked in their usual offices for 8 weeks. The EG and CG came back 4 weeks after the intervention for CFT retention. The EG improved CFT motor efficiency and the amount of moderate PA, while it reduced mental load. The EG retained reached motor efficiency levels 4 weeks after the intervention. No differences were found in IPAQ. The UP150 demonstrated to be a proactive environment and to be efficient in the promotion of PA, improving PF and mental health while decreasing mental load.",2022,"The UP150 demonstrated to be a proactive environment and to be efficient in the promotion of PA, improving PF and mental health while decreasing mental load.",['Forty-five employees'],"['Physical activity (PA', 'UP150, a multifactorial workplace intervention', 'UP150']","['NASA-TLX questionnaire and psycho-physical health', 'IPAQ', 'level of physical fitness (PF) and wellbeing', 'CFT motor efficiency']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242776', 'cui_str': 'National Aeronautics and Space Administration'}, {'cui': 'C1505678', 'cui_str': 'CD46 protein, human'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C1332833', 'cui_str': 'Calcifying fibrous tumor'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",45.0,0.00686898,"The UP150 demonstrated to be a proactive environment and to be efficient in the promotion of PA, improving PF and mental health while decreasing mental load.","[{'ForeName': 'Pietro Luigi', 'Initials': 'PL', 'LastName': 'Invernizzi', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, 20129 Milan, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Signorini', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, 20129 Milan, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Scurati', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, 20129 Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Michielon', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, 20129 Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Benedini', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, 20129 Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bosio', 'Affiliation': 'Human Performance Laboratory, Mapei Sport Research Centre, 21057 Olgiate Olona, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Staiano', 'Affiliation': 'Department of Physical Education and Sport, University of Valencia, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph19031175']
2082,35162166,"Psychotherapeutic Techniques for Distressing Memories: A Comparative Study between EMDR, Brainspotting, and Body Scan Meditation.","OBJECTIVES


We explored the effects of a single 40-min session of Eye Movement Desensitization and Reprocessing (EMDR), Brainspotting (BSP), and Body Scan Meditation (BSM) in the processing of distressing memories reported by a non-clinical sample of adult participants.
DESIGN


A within-subject design was used.
METHODS


Participants ( n  = 40 Psychologists/MDs) reported four distressing memories, each of which treated with a single intervention. EMDR, BSP, and BSM were compared with each other, and with a Book Reading (BR) active control condition, using as dependent measures, SUD (Subjective Units of Disturbance) and Memory Telling Duration (MTD) on a 4-point timeline: Baseline, Pre-Intervention, Post-Intervention, Follow-up.
RESULTS


SUD scores associated with EMDR, BSP, and BSM significantly decreased from Pre- to Post-Intervention ( p  < 0.001). At Post-Intervention and Follow-up, EMDR and BSP SUD scores were significantly lower than BSM and BR scores ( p  < 0.02). At both Post-Intervention and Follow-up, BSM SUD scores were lower than BR scores ( p  < 0.01). A reduction in MTD was observed from Pre- to Post-Intervention for EMDR and BSP conditions ( p  < 0.001).
CONCLUSIONS


Overall, results showed beneficial effects of single sessions of EMDR, BSP, or BSM in the processing of healthy adults' distressing memories. Study limitations and suggestions for future research are discussed.",2022,"A reduction in MTD was observed from Pre- to Post-Intervention for EMDR and BSP conditions ( p  < 0.001).
","['Distressing Memories', 'distressing memories reported by a non-clinical sample of adult participants', 'Participants ( n  = 40 Psychologists/MDs) reported four distressing memories, each of which treated with a single intervention']","['Psychotherapeutic Techniques', 'single 40-min session of Eye Movement Desensitization and Reprocessing (EMDR), Brainspotting (BSP), and Body Scan Meditation (BSM', 'EMDR and BSP']","['EMDR, BSP, and BSM', ""EMDR, BSP, or BSM in the processing of healthy adults' distressing memories"", 'MTD', 'BSM and BR scores', 'BSM SUD scores', 'SUD (Subjective Units of Disturbance) and Memory Telling Duration (MTD', 'SUD scores']","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0243895,"A reduction in MTD was observed from Pre- to Post-Intervention for EMDR and BSP conditions ( p  < 0.001).
","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': ""D'Antoni"", 'Affiliation': 'Maternal Infant Services Unit of Udine, Azienda Sanitaria Universitaria Integrata Friuli Centrale (ASUFC), 33100 Udine, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Matiz', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, 33100 Udine, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Fabbro', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, 33100 Udine, Italy.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Crescentini', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, 33100 Udine, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph19031142']
2083,35162129,Can Product Information Steer towards Sustainable and Healthy Food Choices? A Pilot Study in an Online Supermarket.,"Sustainable dietary choices have become increasingly important because of the current environmental threats the world is facing. Nonetheless, consumers find it difficult to assess a product's sustainability and therefore make better choices. This pilot study tested whether explanatory product information about sustainability increased sustainable purchases in an online supermarket and whether additional health information increased message effectiveness. Perceived consumer effectiveness (i.e., the perception of the degree to which individual actions can contribute to environmental problems) and green skepticism were hypothesized to mediate the effect of message type, and environmental attitudes were included as the moderator. An experiment using a one-factor design was conducted among 101 participants who were assigned to one of three experimental conditions: sustainability claim only, explanatory sustainability claim, and explanatory sustainability and health claim. Analyses showed that an explanatory sustainability claim (regardless of whether this claim was accompanied by a health claim) led to fewer sustainable purchases through perceived consumer effectiveness but only for those with low environmental attitudes. No effects were found for the addition of a health claim. The results from this pilot provide insight for future studies that aim to examine how online supermarkets should communicate to increase sustainable purchases.",2022,This pilot study tested whether explanatory product information about sustainability increased sustainable purchases in an online supermarket and whether additional health information increased message effectiveness.,['101 participants who were assigned to one of three experimental conditions'],"['sustainability claim only, explanatory sustainability claim, and explanatory sustainability and health claim']",[],"[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}]",[],101.0,0.02369,This pilot study tested whether explanatory product information about sustainability increased sustainable purchases in an online supermarket and whether additional health information increased message effectiveness.,"[{'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'van der Waal', 'Affiliation': 'Department of Communication and Cognition, Tilburg School of Humanities and Digital Sciences, Tilburg University, 5037 AB Tilburg, The Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Folkvord', 'Affiliation': 'Department of Communication and Cognition, Tilburg School of Humanities and Digital Sciences, Tilburg University, 5037 AB Tilburg, The Netherlands.'}, {'ForeName': 'Rachid', 'Initials': 'R', 'LastName': 'Azrout', 'Affiliation': 'Amsterdam School of Communication Research (ASCoR), University of Amsterdam, 1012 WX Amsterdam, The Netherlands.'}, {'ForeName': 'Corine S', 'Initials': 'CS', 'LastName': 'Meppelink', 'Affiliation': 'Amsterdam School of Communication Research (ASCoR), University of Amsterdam, 1012 WX Amsterdam, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph19031107']
2084,35162340,The Impact of Grounding in Running Shoes on Indices of Performance in Elite Competitive Athletes.,"The introduction of carbon fiber plate shoes has triggered a plethora of world records in running, which has encouraged shoe industries to produce novel shoe designs to enhance running performance, including shoes containing conductor elements or ""grounding shoes"" (GS), which could potentially reduce the energy cost of running. The aim of this study was to examine the physiological and perceptual responses of athletes subjected to grounding shoes during running. Ten elite runners were recruited. Firstly, the athletes performed an incremental running test for VO 2 max and anaerobic threshold (AT) determination, and were familiarized with the two shoe conditions (traditional training shoe (TTS) and GS, the latter containing a conductor element under the insole). One week apart, athletes performed running economy tests (20 min run at 80% of the AT) on a 400 m dirt track, with shoe conditions randomized. VO 2 , heart rate, lactate, and perceived fatigue were registered throughout the experiment. No differences in any of the physiological or perceptual variables were identified between shoe conditions, with an equal running economy in both TTS and GS (51.1 ± 4.2 vs. 50.9 ± 5.1 mL kg -1  min -1 , respectively). Our results suggest that a grounding stimulus does not improve the energy cost of running, or the physiological/perceptual responses of elite athletes.",2022,"No differences in any of the physiological or perceptual variables were identified between shoe conditions, with an equal running economy in both TTS and GS (51.1 ± 4.2 vs. 50.9 ± 5.1 mL kg -1  min -1 , respectively).","['athletes subjected to grounding shoes during running', 'Elite Competitive Athletes', 'Ten elite runners were recruited']","['Grounding in Running Shoes', 'incremental running test for VO 2 max and anaerobic threshold (AT) determination, and were familiarized with the two shoe conditions (traditional training shoe (TTS) and GS, the latter containing a conductor element under the insole']","['VO 2 , heart rate, lactate, and', 'energy cost of running', 'perceived fatigue']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0425273', 'cui_str': 'Competitive athlete'}]","[{'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0402070', 'cui_str': 'Conductor (musical)'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C3873740', 'cui_str': 'Insole'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.124005,"No differences in any of the physiological or perceptual variables were identified between shoe conditions, with an equal running economy in both TTS and GS (51.1 ± 4.2 vs. 50.9 ± 5.1 mL kg -1  min -1 , respectively).","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Muniz-Pardos', 'Affiliation': 'Faculty of Health and Sports Science (FCSD), Department of Physiatry and Nursing, University of Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Zelenkova', 'Affiliation': 'GENUD (Growth, Exercise, Nutrition and Development) Research Group, Department of Physiatry and Nursing, University of Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Gonzalez-Aguero', 'Affiliation': 'Faculty of Health and Sports Science (FCSD), Department of Physiatry and Nursing, University of Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Knopp', 'Affiliation': 'adidas Innovation, adidas AG, 91074 Herzogenaurach, Germany.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Boitz', 'Affiliation': 'adidas Innovation, adidas AG, 91074 Herzogenaurach, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': 'adidas Innovation, adidas AG, 91074 Herzogenaurach, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ruiz', 'Affiliation': 'adidas Innovation, adidas AG, 91074 Herzogenaurach, Germany.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Casajus', 'Affiliation': 'GENUD (Growth, Exercise, Nutrition and Development) Research Group, Department of Physiatry and Nursing, University of Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Yannis P', 'Initials': 'YP', 'LastName': 'Pitsiladis', 'Affiliation': 'International Federation of Sports Medicine (FIMS), 1007 Lausanne, Switzerland.'}]",International journal of environmental research and public health,['10.3390/ijerph19031317']
2085,35162339,Effects of Acute Yohimbine Hydrochloride Supplementation on Repeated Supramaximal Sprint Performance.,"The purpose of this study was to examine the effects of a single acute dose of yohimbine hydrochloride on repeated anaerobic sprint ability. Physically active females ( n  = 18) completed two separate repeated supramaximal sprint trials each with a different single-dose treatment: placebo (PL; gluten-free corn starch) or yohimbine hydrochloride (YHM; 2.5 mg). For each trial, participants consumed their respective treatment 20 min before exercise. Following a warm-up, participants completed 3 × 15 s Wingate anaerobic tests (WAnTs) separated by 2 min of active recovery. A capillary blood sample was obtained pre- and immediately post-exercise to measure blood concentrations of lactate (LA), epinephrine (EPI), and norepinephrine (NE). Heart rate (HR) and rate of perceived exertion (RPE) were measured following each WAnT. Findings showed that mean power ( p  < 0.001; η 2  = 0.024), total work ( p  < 0.001; η 2  = 0.061), and HR ( p  < 0.001; η 2  = 0.046), were significantly higher with YHM supplementation versus PL. Fatigue index ( p  < 0.001; η 2  = 0.054) and post-exercise LA ( p  < 0.001; d = 1.26) were significantly lower with YHM compared to PL. YHM resulted in significantly higher EPI concentrations versus PL ( p  < 0.001; η 2  = 0.225) pre- and post-exercise while NE only increased as a function of time ( p  < 0.001; η 2  = 0.227) and was unaffected by treatment. While RPE increased after each WAnT, no differences between treatments were observed ( p  = 0.539; η 2  < 0.001). Together, these results suggest that acute YHM ingestion imparts ergogenic benefits which may be mediated by lower blood LA and fatigue concomitantly occurring with blood EPI increases. Thus, YHM may improve sprint performance although more mechanistic study is warranted to accentuate underlying processes mediating performance enhancement.",2022,YHM resulted in significantly higher EPI concentrations versus PL ( p  < 0.001; η 2  = 0.225) pre- and post-exercise while NE only increased as a function of time ( p  < 0.001; η 2  = 0.227) and was unaffected by treatment.,['Physically active females ( n  = 18'],"['yohimbine hydrochloride', 'YHM', 'Acute Yohimbine Hydrochloride Supplementation', 'placebo (PL; gluten-free corn starch) or yohimbine hydrochloride (YHM']","['Fatigue index', 'Heart rate (HR) and rate of perceived exertion (RPE', 'Repeated Supramaximal Sprint Performance', 'total work', 'EPI concentrations', 'sprint performance', 'blood concentrations of lactate (LA), epinephrine (EPI), and norepinephrine (NE', 'repeated anaerobic sprint ability', 'function of time', 'blood LA and fatigue']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0521933', 'cui_str': 'Yohimbine hydrochloride'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",,0.144776,YHM resulted in significantly higher EPI concentrations versus PL ( p  < 0.001; η 2  = 0.225) pre- and post-exercise while NE only increased as a function of time ( p  < 0.001; η 2  = 0.227) and was unaffected by treatment.,"[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Barnes', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, Homewood, AL 35229, USA.'}, {'ForeName': 'Camryn R', 'Initials': 'CR', 'LastName': 'Cowan', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, Homewood, AL 35229, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Boag', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, Homewood, AL 35229, USA.'}, {'ForeName': 'Julianne G', 'Initials': 'JG', 'LastName': 'Hill', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, Homewood, AL 35229, USA.'}, {'ForeName': 'Morgan L', 'Initials': 'ML', 'LastName': 'Jones', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, Homewood, AL 35229, USA.'}, {'ForeName': 'Kylie M', 'Initials': 'KM', 'LastName': 'Nixon', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, Homewood, AL 35229, USA.'}, {'ForeName': 'Mckenzie G', 'Initials': 'MG', 'LastName': 'Parker', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, Homewood, AL 35229, USA.'}, {'ForeName': 'Shelby K', 'Initials': 'SK', 'LastName': 'Parker', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, Homewood, AL 35229, USA.'}, {'ForeName': 'Mary V', 'Initials': 'MV', 'LastName': 'Raymond', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, Homewood, AL 35229, USA.'}, {'ForeName': 'Lillie H', 'Initials': 'LH', 'LastName': 'Sternenberg', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, Homewood, AL 35229, USA.'}, {'ForeName': 'Shelby L', 'Initials': 'SL', 'LastName': 'Tidwell', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, Homewood, AL 35229, USA.'}, {'ForeName': 'Taylor M', 'Initials': 'TM', 'LastName': 'Yount', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, Homewood, AL 35229, USA.'}, {'ForeName': 'Tyler D', 'Initials': 'TD', 'LastName': 'Williams', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, Homewood, AL 35229, USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Rogers', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, Homewood, AL 35229, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Ballmann', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, Homewood, AL 35229, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph19031316']
2086,35162813,Do Sleep Disturbances Improve Following Psychoanalytic Psychotherapy for Adolescent Depression?,"Sleep disturbance is often a prominent symptom in adolescents diagnosed with major depressive disorder (MDD). Recent evidence indicates that short-term psychoanalytic psychotherapy (STPP) for depression may have an effect in reducing co-occurring sleep disturbance in youth. It is unknown if transference work (exploration of the patient-therapist relationship) has an additional effect in reducing sleep disturbance. Adolescents aged 16-18 years ( n  = 69, 84% female) who met diagnostic criteria for MDD based on the Mini International Neuropsychiatric Interview (M.I.N.I) were randomized to either STPP with transference work or without. Sleep problems were assessed at baseline, therapy session 20 (20 weeks), post-treatment (28 weeks), and one-year follow-up (80 weeks) with the Symptom Checklist-90-R. At baseline, 69% of the adolescents exhibited moderately to extreme sleep difficulties. Sleep disturbance was significantly correlated to depression depth at session 20 and at follow-up. Symptoms of insomnia significantly decreased from baseline to the end of treatment. Treatment gains were maintained until follow-up. No differences in recovery of sleep disturbance were found between the two treatment groups. The findings suggest that sleep disturbance improves following STPP for depression, with or without transference work. Future research should assess those with residual symptoms by different sleep measures.",2022,No differences in recovery of sleep disturbance were found between the two treatment groups.,"['adolescents diagnosed with major depressive disorder (MDD', 'Adolescents aged 16-18 years ( n  = 69, 84% female) who met diagnostic criteria for MDD based on the Mini International Neuropsychiatric Interview (M.I.N.I']","['STPP with transference work or without', 'Psychoanalytic Psychotherapy', 'short-term psychoanalytic psychotherapy (STPP']","['Sleep problems', 'Symptoms of insomnia', 'recovery of sleep disturbance', 'Sleep disturbance']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0040678', 'cui_str': 'Transference'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]",,0.178531,No differences in recovery of sleep disturbance were found between the two treatment groups.,"[{'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Schønning', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, P.O. Box 1171, 0318 Oslo, Norway.'}, {'ForeName': 'Hanne-Sofie Johnsen', 'Initials': 'HJ', 'LastName': 'Dahl', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3, 0370 Oslo, Norway.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hummelen', 'Affiliation': 'Department of Research and Innovation, Division of Mental Health and Addiction, Oslo University Hospital, P.O. Box 4959, 0424 Oslo, Norway.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Ulberg', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, P.O. Box 1171, 0318 Oslo, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph19031790']
2087,35162806,The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in Portugal: Feasibility Study Results.,"The Unified Protocol for Children (UP-C) is a transdiagnostic Cognitive-Behavioral Therapy group intervention for children and caregivers targeting the treatment of children's emotional disorders (EDs). The present study aims to assess the feasibility and acceptability of the UP-C in the Portuguese population using a single-armed design. The participants were 32 children (6-12 years of age) with an ED (anxiety and/or depressive disorder) as a main diagnosis and their parents. All participants received the UP-C intervention and were assessed at pretreatment, midtreatment, posttreatment, and 3 months posttreatment. Children, parents, the clinicians, and an external observer completed questionnaires to assess the feasibility and acceptability of the UP-C (e.g., satisfaction, motivation, and adherence). Children and parents also completed self-report measures assessing the children's anxiety and depression and its interference and severity. The results of the present study support the feasibility and acceptability of the UP-C in Portugal; low dropout rates, high adherence rates, and high levels of child and parent satisfaction and motivation were observed. Moreover, significant reductions over time in children's levels of anxiety and/or depression and of its interference and severity were found and were maintained after 3 months of follow-up. These results are promising and warrant a subsequent randomized controlled trial (RCT).",2022,"Moreover, significant reductions over time in children's levels of anxiety and/or depression and of its interference and severity were found and were maintained after 3 months of follow-up.","['participants were 32 children (6-12 years of age) with an ED (anxiety and/or depressive disorder) as a main diagnosis and their parents', ""children and caregivers targeting the treatment of children's emotional disorders (EDs"", 'Emotional Disorders in Children (UP-C) in Portugal']",['transdiagnostic Cognitive-Behavioral Therapy group intervention'],"['feasibility and acceptability of the UP-C (e.g., satisfaction, motivation, and adherence', 'adherence rates, and high levels of child and parent satisfaction and motivation', ""children's anxiety and depression and its interference and severity"", 'anxiety and/or depression and of its interference and severity', 'feasibility and acceptability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",32.0,0.0474489,"Moreover, significant reductions over time in children's levels of anxiety and/or depression and of its interference and severity were found and were maintained after 3 months of follow-up.","[{'ForeName': 'Brígida', 'Initials': 'B', 'LastName': 'Caiado', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Rua do Colégio Novo, 3030-115 Coimbra, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Góis', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Rua do Colégio Novo, 3030-115 Coimbra, Portugal.'}, {'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Faculty of Psychology and Educational Sciences, University of Coimbra, Rua do Colégio Novo, 3030-115 Coimbra, Portugal.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Canavarro', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Rua do Colégio Novo, 3030-115 Coimbra, Portugal.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Moreira', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Rua do Colégio Novo, 3030-115 Coimbra, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph19031782']
2088,35162842,Evaluating the Oral-Health-Related Quality of Life of Oral Submucous Fibrosis Patients before and after Treatment Using the OHIP-14 Tool.,"The objective of the present study was to assess the oral-health-related quality of life (OHRQoL) of oral submucous fibrosis (OSMF) patients before and after standard treatment. A convenient sampling technique was used to recruit the clinically diagnosed patients of OSMF (n = 130). Based on the medical treatment, the patients were randomly divided into two study groups (group A and B). The group A patients received submucosal intralesional injections of dexamethasone (2 mL; 4 gm/mL), while group B patients received hyaluronidase (1500 IU). Both the group A and B patients received respective medical therapy biweekly for a period of five weeks. At the follow up visit (6 months), the impact of treatment on OHRQoL was assessed using the Oral Health Impact Profile-14 (OHIP-14). Data were analyzed by a chi-square test for quantitative variables and an independent  t -test for qualitative variables. The comparison of all clinical parameters before and after treatment was performed by a paired  t -test. The results after treatment showed that there was a significant improvement in all domains of OHIP-14 ( p  = 0.001) except psychological disability ( p  = 0.243). In addition, the OHRQoL of patients was significantly improved following the treatment.",2022,The results after treatment showed that there was a significant improvement in all domains of OHIP-14 ( p  = 0.001) except psychological disability ( p  = 0.243).,['clinically diagnosed patients of OSMF (n = 130'],['submucosal intralesional injections of dexamethasone'],"['psychological disability', 'OHIP-14', 'OHRQoL', 'Oral-Health-Related Quality of Life', 'oral-health-related quality of life (OHRQoL']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029172', 'cui_str': 'Oral submucosal fibrosis'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0021490', 'cui_str': 'Intralesional injection'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0229459,The results after treatment showed that there was a significant improvement in all domains of OHIP-14 ( p  = 0.001) except psychological disability ( p  = 0.243).,"[{'ForeName': 'Abdul Bari', 'Initials': 'AB', 'LastName': 'Memon', 'Affiliation': 'Medical Research Centre, Liaquat University of Medical and Health Sciences, Jamshoro 76090, Pakistan.'}, {'ForeName': 'Aneela Atta Ur', 'Initials': 'AAU', 'LastName': 'Rahman', 'Affiliation': 'Medical Research Centre, Liaquat University of Medical and Health Sciences, Jamshoro 76090, Pakistan.'}, {'ForeName': 'Kashif Ali', 'Initials': 'KA', 'LastName': 'Channar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Institute of Dentistry, Liaquat University of Medical and Health Sciences, Jamshoro 76090, Pakistan.'}, {'ForeName': 'Muhammad Sohail', 'Initials': 'MS', 'LastName': 'Zafar', 'Affiliation': 'Department of Restorative Dentistry, College of Dentistry, Taibah University, Al Madinah, Al Munawwarah 41311, Saudi Arabia.'}, {'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Medical Research Centre, Liaquat University of Medical and Health Sciences, Jamshoro 76090, Pakistan.'}]",International journal of environmental research and public health,['10.3390/ijerph19031821']
2089,35165477,[Evaluation of bioceramic putty repairmen iRoot and mineral trioxide aggregate in mature permanent teeth pulpotomy].,"OBJECTIVE


To evaluate the clinical characteristics and effectiveness of pulpotomy in mature permanent teeth with bioceramic putty repairmen iRoot and mineral trioxide aggregate (MTA).
METHODS


Pulpotomy was performed on mature permanent premolars and molars with carious exposures at the Department of General Dentistry of Peking University School and Hospital of Stomatology, from November 2017 to September 2019. The patients were randomly divided into 2 groups, Group iRoot ( n =22) and Group MTA ( n =21). In Group iRoot, bioceramic putty repairmen iRoot was used as pulp capping agent, while in Group MTA, mineral trioxide aggregate was used as pulp capping agent. All the patients had signed informed consent forms. The clinical efficacy was evaluated by clinical examinations (temperature and electrical activity test) and imaging examinations 3, 6, and 12 months after surgery. Blinding was used for the patients and evaluators, but due to the obvious differences in the properties of the two pulp capping agents, the blinding method was not used for the treatment provider (the attending physician).
RESULTS


There was no significant difference in gender, average age, dentition and tooth position distribution between the two groups ( P >0.05). In the study, 7 cases were lost to follow-up 12 months after operation (4 cases in Group iRoot, and 3 cases in Group MTA). One case in each of the two groups had transient sensitivity at the end of the 3-month follow-up, and the pulp vitality was normal at the end of the 6-month follow-up. One case in Group iRoot showed sensitivity at the end of the 12-month follow-up. The success rates of the two groups at the end of 12-month follow-up were 100%, and the cure rates were 94.4% (Group iRoot) and 100% (Group MTA), respectively, and the difference was not statistically significant ( P >0.05). No cases in Group iRoot had obvious crown discoloration, while 3 cases in Group MTA had.
CONCLUSION


The clinical characteristics and effectiveness of pulpotomy in mature permanent teeth with bioceramic putty repairmen iRoot were similar with MTA. Bioceramic putty repairmen iRoot is an acceptable material when used in pulpotomy of mature permanent teeth. Because it is not easy to cause tooth discoloration after treatment and is convenient to operate, bioceramic putty repairmen iRoot has a better clinical application prospect.",2022,"There was no significant difference in gender, average age, dentition and tooth position distribution between the two groups ( P >0.05).","['mature permanent teeth with bioceramic putty repairmen iRoot and mineral trioxide aggregate (MTA', 'mature permanent premolars and molars with carious exposures at the Department of General Dentistry of Peking University School and Hospital of Stomatology, from November 2017 to September 2019', 'mature permanent teeth with bioceramic putty repairmen', 'mature permanent teeth pulpotomy']","['bioceramic putty repairmen iRoot and mineral trioxide aggregate', 'pulpotomy']","['gender, average age, dentition and tooth position distribution', 'cure rates', 'success rates', 'sensitivity', 'clinical efficacy', 'transient sensitivity', 'obvious crown discoloration', 'pulp vitality']","[{'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0017318', 'cui_str': 'General dental practice'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029167', 'cui_str': 'Medicine, Oral'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}]","[{'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011443', 'cui_str': 'Dentition'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}]",7.0,0.00963552,"There was no significant difference in gender, average age, dentition and tooth position distribution between the two groups ( P >0.05).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Qian', 'Affiliation': 'Department of General Dentistry, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of General Dentistry, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}, {'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Zhu', 'Affiliation': 'Department of General Dentistry, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Zhao', 'Affiliation': 'Department of General Dentistry, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of General Dentistry, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Yong', 'Affiliation': 'Department of General Dentistry, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
2090,35165474,[Effects of the resin base and retention depth on fracture resistance of molars restored with nano-ceramic endocrowns].,"OBJECTIVE


To compare the effects of resin base and different retention depth on the fracture resistance of mandibular molars restored with nano-ceramic endocrowns.
METHODS


Forty mandibular molars selected and randomly divided into 5 groups: ① The control group which was consisted of intact teeth, ② the non-resin base group, ③ the 2 mm retention depth group, ④ the 3 mm retention depth group, ⑤ the 4 mm retention depth group, respectively. After tooth preparation,  in vitro  root canal therapy was conducted, which was followed by endocrown design, production and adhesive of groups ②-⑤. All the samples were under load (N) of the universal mechanical testing machine after embedding. The fracture pattern of each sample was observed under stereomicroscope. Then the microstructure of the fracture surface was observed by scanning electron microscopy.
RESULTS


The fracture loads of each group were respectively: the control group fracture load was (3 069.34±939.50) N; experimental groups: fracture load of (2 438.04±774.40) N for the group without resin base; fracture load of (3 537.18±763.65) N for the group with 2 mm retention depth. The fracture load of the retention depth 3 mm group was (2 331.55±766.39) N; the fracture load of the retention depth 4 mm group was (2 786.98±709.24) N. There was statistical significance in the effect of resin base and different retention depth on the fracture loads of molars restored with nano-ceramic endocrown ( P  < 0.05). Repairable fractures in each group were as follows: control group 2/8, non-resin base group 1/8, retention depth of 2 mm group 1/8, retention depth of 3 mm group 2/8, and retention depth of 4 mm group 0/8. The effects of the retention depth and the presence of resin base on the fracture resistance of the resin nano-ceramic endocrowns were statistically significant ( P  < 0.05). Scanning electron microscopy showed more arrest lines and small twist hackles on the fracture surface of the restorations with resin base (retention depths of 2 mm, 3 mm, and 4 mm), with cracks extending towards the root. In addition to the characteristics above, more transverse cracks parallel to the occlusal surface, pointing outwards from the center of the pulp cavity retention, were also observed on the fracture surface of the non-resin base restorations.
CONCLUSION


When molar teeth with nano-ceramic endocrowns are restored, resin base and the retention depth of 2 mm help the teeth to obtain optimal fracture strength.",2022,There was statistical significance in the effect of resin base and different retention depth on the fracture loads of molars restored with nano-ceramic endocrown ( P  < 0.05).,"['Forty mandibular molars', 'molars restored with nano-ceramic endocrowns', 'mandibular molars restored with nano-ceramic endocrowns']","['resin base and retention depth', 'control group which was consisted of intact teeth, ② the non-resin base group, ③ the 2 mm retention depth group, ④ the 3 mm retention depth group, ⑤ the 4 mm retention depth', 'resin base and different retention depth']","['fracture loads', 'fracture resistance']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}]","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",40.0,0.0408216,There was statistical significance in the effect of resin base and different retention depth on the fracture loads of molars restored with nano-ceramic endocrown ( P  < 0.05).,"[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Cariology and Endodontology, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digtal Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}, {'ForeName': 'Y X', 'Initials': 'YX', 'LastName': 'Xu', 'Affiliation': 'Department of Dental Materials, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digtal Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}, {'ForeName': 'X D', 'Initials': 'XD', 'LastName': 'Bao', 'Affiliation': 'Department of Cariology and Endodontology, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digtal Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Wang', 'Affiliation': 'Department of Cariology and Endodontology, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digtal Stomatology & NHC Research Center of Engineering and Technology for Computerized Dentistry & NMPA Key Laboratory for Dental Materials, Beijing 100081, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
2091,35165472,[Effect of a novel radio-frequency atmospheric-pressure glow discharge plasma jet treatment on crosslinking of dentin collagen].,"OBJECTIVE


To investigate the effect of a noval radio-frequency atmospheric-pressure glow discharge (RF-APGD) plasma jet on crosslinking of dentin collagen.
METHODS


(1) Twenty intact third molars were collected. The middle dentin discs were prepared for each tooth by low-speed water-cooled Isomet saw, and then immersed in 10% (mass fraction) H 3 PO 4  solution for 16 h to obtain fully demine-ralized dentin collagen. The twenty dentin discs were then randomly divided into five groups. The control group was untreated while the four experimental groups were treated by plasma jet with gas temperature of 4 ℃ for different times (20 s, 30 s, 40 s, and 50 s). The structure and crosslinking degree of dentin collagen were characterized by attenuated total reflection-Fourier transform infrared spectroscopy. The surface morphology of demineralized dentin was observed by scanning electron microscope, and the microstructure was observed by transmission electron microscope. (2) Fourty non-caries third molars were collected to prepare 5 g fine dentin powder, then completely demineralized with 10% H 3 PO 4  solution. The control group was untreated, while the four experimental groups were treated by plasma jet for 20 s, 30 s, 40 s and 50 s. The crosslinking degree of each group was determined by ninhydrin colorimetric method. (3) Forty intact third molars were collected to obtain dentin strips. Only two central symmetrical dentin strips (nasty 80) were taken from each tooth and immersed in 10% H 3 PO 4  solution for 16 h to obtain fully demineralized dentin collagen. Eighty dentine collagen fiber strips were randomly divided into five groups. The control group was untreated and the axial surfaces of dentin collagen fiber strips in the expe-rimental groups were treated with the plasma jet for 20 s, 30 s, 40 s and 50 s. The ultimate tensile strength of dentin was measured by universal mechanical machine.
RESULTS


(1) The surface morphology of demineralized dentin observed by scanning electron microscope showed that the network structure of collagen fibers on the surface of demineralized dentin treated with the plasma jet for 20 s, 30 s and 40 s could maintain the uncollapsed three-dimensional structure, and part of the microstructure was destroyed after plasma jet treated for 50 s. After being treated by plasma jet for 20 s, 30 s and 40 s, the three-dimensional structure was uncollapsed, and the typical periodic transverse pattern of natural type Ⅰ collagen fiber could be seen. The results of infrared spectra showed that the secondary conformation of dentin collagen fibers was the same as that of the control group after being treated with the plasma jet, and the intensity of amide band was significantly increased after being treated for 30 s and 40 s. (2) The results of ninhydrin crosslinking test showed that the crosslinking ratio of dentin collagen treated by plasma jet for 30 s and 40 s was the highest, and the difference was statistically significant ( P  < 0.05). (3) The results of dentin ultimate tensile strength showed that the control group was (1.67±0.24) MPa, and the plasma jet treated 20 s, 30 s, 40 s and 50 s groups were (4.21±0.15) MPa, (7.06±0.30) MPa, (7.32±0.27) MPa, and (6.87±0.17) MPa, which were significantly different from that of the control group ( P  < 0.05).
CONCLUSION


The novel RF-APGD plasma jet treatment can promote the crosslinking degree of demineralized dentin collagen and improve their ultimate tensile strength.",2022,"The results of dentin ultimate tensile strength showed that the control group was (1.67±0.24) MPa, and the plasma jet treated 20 s, 30 s, 40 s and 50 s groups were (4.21±0.15) MPa, (7.06±0.30) MPa, (7.32±0.27) MPa, and (6.87±0.17) MPa, which were significantly different from that of the control group ( P  < 0.05).
","['2) Fourty non-caries third molars', '1) Twenty', 'Eighty dentine collagen fiber strips', 'twenty dentin discs']","['novel radio-frequency atmospheric-pressure glow discharge plasma jet treatment', 'noval radio-frequency atmospheric-pressure glow discharge (RF-APGD) plasma jet']","['ultimate tensile strength of dentin', 'dentin ultimate tensile strength', 'crosslinking ratio of dentin collagen', 'surface morphology of demineralized dentin', 'intensity of amide band', 'crosslinking of dentin collagen', 'secondary conformation of dentin collagen fibers']","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0225325', 'cui_str': 'Collagen fiber'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004180', 'cui_str': 'Atmospheric Pressure'}, {'cui': 'C4748924', 'cui_str': 'Global developmental delay, lung cysts, overgrowth, Wilms tumor syndrome'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1540845', 'cui_str': 'Tensile strength'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0002482', 'cui_str': 'Amide'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026377', 'cui_str': 'Molecular conformation'}, {'cui': 'C0225325', 'cui_str': 'Collagen fiber'}]",80.0,0.0219289,"The results of dentin ultimate tensile strength showed that the control group was (1.67±0.24) MPa, and the plasma jet treated 20 s, 30 s, 40 s and 50 s groups were (4.21±0.15) MPa, (7.06±0.30) MPa, (7.32±0.27) MPa, and (6.87±0.17) MPa, which were significantly different from that of the control group ( P  < 0.05).
","[{'ForeName': 'X R', 'Initials': 'XR', 'LastName': 'Ma', 'Affiliation': 'Department of Prothodontics, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing 100081, China.'}, {'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Zhu', 'Affiliation': 'Second Clinical Division, Peking University School and Hospital of Stomatology, Beijing 100101, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Engineering Physics, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Li', 'Affiliation': 'Second Clinical Division, Peking University School and Hospital of Stomatology, Beijing 100101, China.'}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Li', 'Affiliation': 'Department of Engineering Physics, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Tan', 'Affiliation': 'Department of Prothodontics, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing 100081, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
2092,35165471,[Application of cold flowable gutta-percha in root canal obturation after apexification].,"OBJECTIVE


To evaluate the clinical effect of root canal obturation therapy using cold flowable gutta-percha on young permanent teeth after apexification.
METHODS


Ninety cases of young permanent teeth with pulp necrosis or periapical periodontitis treated by apexification were randomly divided into two groups. The cases in each group were divided into single root canal and multiple root canal according to the number of the root canal, and divided into classifications Ⅰ, and Ⅱ/Ⅲ/Ⅳ according to Frank's classification of root development after apexification. Cold flowable gutta-percha and warm gutta-percha obturation techniques were used for root canal obturation of the two groups. The operation time was recorded, and the patients' therapy pain degree was evaluated by visual analog scale (VAS) immediately after operation. Periapical X-ray was performed after operation to evaluate the effect of the root canal filling. The total length of the root was divided into equal three parts on the X-ray film, and three-dimensional tightness of the apical, middle, and coronal region of the root canals were statistically analyzed respectively. Clinical examinations and X-ray examination were performed 6 and 12 months after the operation to evaluate the treatment success rate.
RESULTS


The operation time of cold flowable gutta-percha group was significantly lower than that of the control group, which were 51 s and 74 s ( P  < 0.05); The percentages of pain and discomfort in the two groups were 26.67% and 40.00%, respectively. There were two cases of underfilling and no overfilling in both groups. The percentages of proper filling and tight three-dimensional obturation in the experimental and control groups were 71.11% and 60.00% respectively; and the percentages of tight three-dimensional obturation in the apical third areas were 86.67% and 66.67%, the difference was significant ( P  < 0.05). There was no significant difference in the three-dimensional tightness between the two groups in the middle and coronal third areas. The percentages of tight three-dimensional obturation in classification Ⅰ groups were 86.67%, 83.33%, 93.33% and 76.67%, 90.00%, 96.67% in experimental and control group, respectively; The percentages of classification Ⅱ/Ⅲ/Ⅳ groups were 86.67%, 86.67%, 100.00% and 46.67%, 86.67%, 100.00%, respectively, and the difference was significant ( P  < 0.05). There were no apical lesions that occurred in either group during the one-year review period.
CONCLUSION


The application of cold flowable gutta-percha on young permanent teeth root canal obturation after apexification can achieve good obturation effect. The root obturation effect in the apical third area is significantly better than that of warm gutta-percha obturation techniques. Cold flowable gutta-percha can shorten the clinical treatment time and ameliorate the patients' therapy comfort.",2022,There was no significant difference in the three-dimensional tightness between the two groups in the middle and coronal third areas.,"['young permanent teeth after apexification', 'Ninety cases of young permanent teeth with pulp necrosis or periapical periodontitis treated by apexification']","['Cold flowable gutta-percha and warm gutta-percha obturation techniques', 'cold flowable gutta-percha', 'root canal obturation therapy']","['root obturation effect', 'three-dimensional tightness', 'percentages of tight three-dimensional obturation', 'total length of the root', 'percentages of proper filling and tight three-dimensional obturation', 'percentages of pain and discomfort', 'visual analog scale (VAS', 'operation time of cold flowable gutta', 'operation time']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C2193547', 'cui_str': 'Apexification'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011407', 'cui_str': 'Necrosis of the pulp'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0449861', 'cui_str': 'Obturation technique'}, {'cui': 'C0035848', 'cui_str': 'Root canal obturation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}]",90.0,0.0263311,There was no significant difference in the three-dimensional tightness between the two groups in the middle and coronal third areas.,"[{'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Yan', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Lin', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Ding', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'X X', 'Initials': 'XX', 'LastName': 'Chen', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
2093,35177293,"Reply to the letter to the editor: Effects of adequate dietary protein with whey protein, leucine, and vitamin D supplementation on sarcopenia in older adults: An open-label, parallel-group study.","This is a response to the comment on our published article ""Effects of adequate dietary protein with whey protein, leucine, and vitamin D supplementation on sarcopenia in older adults: An open-label, parallel-group study"". Safer et al., questioned about the procedure and consistency of bioelectrical impedance analysis (BIA) measurement at the baseline and follow up visits. Also, they wondered whether the BIA device we used is validated in Taiwanese older adults with sarcopenia. We followed the standard protocols and the procedures were consistent at each measurement. Magnetic resonance image (MRI) and dual energy X ray absorptiometry (DXA) are gold standards for quantifying muscle mass. According to the clinical trials performed in Taiwan, the BIA device we used showed a significant correlation with MRI and DXA and is validated in older adults with sarcopenia in Taiwan. Trial registration: ClinicalTrials.gov NCT03860194.",2022,"According to the clinical trials performed in Taiwan, the BIA device we used showed a significant correlation with MRI and DXA and is validated in older adults with sarcopenia in Taiwan.","['Taiwanese older adults with sarcopenia', 'older adults with sarcopenia in Taiwan', 'older adults']","['Magnetic resonance image (MRI) and dual energy X ray absorptiometry (DXA', 'adequate dietary protein with whey protein, leucine, and vitamin D supplementation']",[],"[{'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]",[],,0.090254,"According to the clinical trials performed in Taiwan, the BIA device we used showed a significant correlation with MRI and DXA and is validated in older adults with sarcopenia in Taiwan.","[{'ForeName': 'Chih-Chien', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Department of Family Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Sung-Ling', 'Initials': 'SL', 'LastName': 'Yeh', 'Affiliation': 'School of Nutrition and Health Sciences, College of Nutrition, Taipei Medical University, Taipei, Taiwan. Electronic address: sangling@tmu.edu.tw.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2022.01.030']
2094,35177404,Surgical fixation with K-wires versus casting in adults with fracture of distal radius: DRAFFT2 multicentre randomised clinical trial.,,2022,,['adults with fracture of distal radius'],['Surgical fixation with K-wires versus casting'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}]",[],,0.217228,,[],BMJ (Clinical research ed.),['10.1136/bmj.o423']
2095,35162416,Health Effects of a 12-Week Web-Based Lifestyle Intervention for Physically Inactive and Overweight or Obese Adults: Study Protocol of Two Randomized Controlled Clinical Trials.,"Web-based lifestyle interventions have attracted considerable research interest. Available evidence on such interventions suggests health-promoting effects, but further research is needed. Therefore, this study aims to investigate short-, medium-, and long-term health effects of a web-based health program (""TK-HealthCoach"", TK-HC) offered by a national statutory health insurance fund (Techniker Krankenkasse, TK). The study comprises two randomized controlled clinical trials to evaluate the health goals ""Increasing Fitness"" (F clin ) and ""Losing and Maintaining Weight"" (W clin ). A total of  n  = 186 physically inactive (F clin ) and  n  = 150 overweight or obese (W clin ) adults will be randomly assigned to a 12-week interactive (TK-HC) or non-interactive web-based health program using permuted block randomization with a 1:1 allocation ratio. Primary outcomes include cardiorespiratory fitness (F clin ) and body weight (W clin ). Secondary outcomes comprise musculoskeletal fitness (F clin ), physical activity and dietary behavior, anthropometry, blood pressure, blood levels, and vascular health (F clin , W clin ). All outcomes will be measured before and after the 12-week intervention and after a 6- and 12-month follow-up. Additionally, usage behavior data on the health programs will be assessed. Linear mixed models (LMMs) will be used for statistical analysis. Findings of this study will expand the available evidence on web-based lifestyle interventions.",2022,"Secondary outcomes comprise musculoskeletal fitness (F clin ), physical activity and dietary behavior, anthropometry, blood pressure, blood levels, and vascular health (F clin , W clin ).","['Physically Inactive and Overweight or Obese Adults', 'A total of  n  = 186 physically inactive (F clin ) and  n  = 150 overweight or obese (W clin ) adults']","['12-Week Web-Based Lifestyle Intervention', 'health goals ""Increasing Fitness"" (F clin ) and ""Losing and Maintaining Weight"" (W clin ', 'web-based health program (""TK-HealthCoach"", TK-HC', '12-week interactive (TK-HC) or non-interactive web-based health program using permuted block randomization with a 1:1 allocation ratio']","['cardiorespiratory fitness (F clin ) and body weight (W clin ', 'musculoskeletal fitness (F clin ), physical activity and dietary behavior, anthropometry, blood pressure, blood levels, and vascular health (F clin , W clin ']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",186.0,0.0332814,"Secondary outcomes comprise musculoskeletal fitness (F clin ), physical activity and dietary behavior, anthropometry, blood pressure, blood levels, and vascular health (F clin , W clin ).","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Brame', 'Affiliation': 'Department of Sport and Sport Science (DoSS), University of Freiburg, 79117 Freiburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kohl', 'Affiliation': 'Department of Sport and Sport Science (DoSS), University of Freiburg, 79117 Freiburg, Germany.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Wurst', 'Affiliation': 'Department of Sport and Sport Science (DoSS), University of Freiburg, 79117 Freiburg, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Fuchs', 'Affiliation': 'Department of Sport and Sport Science (DoSS), University of Freiburg, 79117 Freiburg, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Tinsel', 'Affiliation': 'Section of Health Care Research and Rehabilitation Research (SEVERA), Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Maiwald', 'Affiliation': 'Section of Health Care Research and Rehabilitation Research (SEVERA), Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Fichtner', 'Affiliation': 'Section of Health Care Research and Rehabilitation Research (SEVERA), Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Armbruster', 'Affiliation': 'Section of Health Care Research and Rehabilitation Research (SEVERA), Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Bischoff', 'Affiliation': 'Section of Health Care Research and Rehabilitation Research (SEVERA), Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Farin-Glattacker', 'Affiliation': 'Section of Health Care Research and Rehabilitation Research (SEVERA), Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lindinger', 'Affiliation': 'Scientific Working Group in Smoking Cessation (WAT) e.V., Department of Psychiatry and Psychotherapy, University Hospital Tübingen, 72076 Tübingen, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Bredenkamp', 'Affiliation': 'Clinical Trials Unit UMG, University Medical Center Göttingen, 37075 Göttingen, Germany.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Gollhofer', 'Affiliation': 'Department of Sport and Sport Science (DoSS), University of Freiburg, 79117 Freiburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'König', 'Affiliation': 'Department of Sport and Sport Science (DoSS), University of Freiburg, 79117 Freiburg, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph19031393']
2096,35162381,"Leg Fidgeting Improves Executive Function following Prolonged Sitting with a Typical Western Meal: A Randomized, Controlled Cross-Over Trial.","Prolonged uninterrupted sitting and a typical Western meal, high in fat and refined sugar, can additively impair cognitive and cerebrovascular functions. However, it is unknown whether interrupting these behaviours, with a simple desk-based activity, can attenuate the impairment. The aim of this study was to determine whether regular leg fidgeting can off-set the detrimental effects of prolonged sitting following the consumption of a typical Western meal, on executive and cerebrovascular function. Using a randomized cross-over design, 13 healthy males consumed a Western meal and completed 180-min of prolonged sitting with leg fidgeting of 1 min on/4 min off (intervention [INT]) and without (control [CON]). Cognitive function was assessed pre and post sitting using the Trail Maker Test (TMT) parts A and B. Common carotid artery (CCA) blood flow, as an index of brain flow, was measured pre and post, and cerebral (FP1) perfusion was measured continuously. For TMT B the CON trial significantly increased (worsened) completion time (mean difference [MD] = 5.2 s,  d  = 0.38), the number of errors (MD = 3.33,  d  = 0.68) and cognitive fatigue (MD = 0.73,  d  = 0.92). Compared to CON, the INT trial significantly improved completion time (MD = 2.3 s,  d  = 0.97), and prevented declines in cognitive fatigue and a reduction in the number of errors. No significant changes in cerebral perfusion or CCA blood flow were found. Leg fidgeting for 1-min on/4-min off following a meal high in fats and refined sugars attenuated the impairment in executive function. This attenuation in executive function may not be caused by alterations in CCA blood flow or cerebral perfusion.",2022,"For TMT B the CON trial significantly increased (worsened) completion time (mean difference [MD] = 5.2 s,  d  = 0.38), the number of errors (MD = 3.33,  d  = 0.68) and cognitive fatigue (MD = 0.73,  d  = 0.92).",['13 healthy males consumed a'],"['Western meal and completed 180-min of prolonged sitting with leg fidgeting of 1 min on/4 min off (intervention [INT]) and without (control [CON', 'CON', 'Prolonged uninterrupted sitting and a typical Western meal, high in fat and refined sugar', 'Leg Fidgeting Improves Executive Function following Prolonged Sitting with a Typical Western Meal']","['Trail Maker Test (TMT) parts A and B. Common carotid artery (CCA) blood flow, as an index of brain flow, was measured pre and post, and cerebral (FP1) perfusion', 'executive function', 'executive and cerebrovascular function', 'number of errors', 'Cognitive function', 'completion time', 'cerebral perfusion or CCA blood flow', 'cognitive fatigue']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0554244', 'cui_str': 'Maker'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",13.0,0.0404002,"For TMT B the CON trial significantly increased (worsened) completion time (mean difference [MD] = 5.2 s,  d  = 0.38), the number of errors (MD = 3.33,  d  = 0.68) and cognitive fatigue (MD = 0.73,  d  = 0.92).","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Fryer', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucestershire GL2 9HW, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Paterson', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucestershire GL2 9HW, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Stoner', 'Affiliation': 'Department of Sport and Exercise, University of North Carolina, Chapel Hill, NC 27514, USA.'}, {'ForeName': 'Meghan A', 'Initials': 'MA', 'LastName': 'Brown', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucestershire GL2 9HW, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Faulkner', 'Affiliation': 'Department of Sport and Exercise, University of Winchester, Hampshire SO22 4NR, UK.'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Turner', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucestershire GL2 9HW, UK.'}, {'ForeName': 'Aitor Martínez', 'Initials': 'AM', 'LastName': 'Aguirre-Betolaza', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport, University of the Basque Country (UPV/EHU), 01006 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Zieff', 'Affiliation': 'Department of Sport and Exercise, University of North Carolina, Chapel Hill, NC 27514, USA.'}, {'ForeName': 'Keeron', 'Initials': 'K', 'LastName': 'Stone', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucestershire GL2 9HW, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph19031357']
2097,35162372,A Game-Based Approach to Lower Blood Pressure? Comparing Acute Hemodynamic Responses to Endurance Exercise and Exergaming: A Randomized Crossover Trial.,"The present randomized crossover study aimed to determine whether an exergaming session in an innovative, functional fitness game could be an effective exercise approach that elicits favorable blood pressure (BP) responses, such as a typical moderate endurance exercise (ET). Therefore, acute hemodynamic responses after a training session in the ExerCube and an ET on a treadmill were assessed and compared. Twenty-eight healthy recreational active participants (13 women; aged 24.8 ± 3.9 years) completed an exergaming session (EX) and an ET in a randomized and counterbalanced order. Before and throughout the 45 min after the training, the peripheral and central BP were measured. After the ET, there was a moderate decrease in both peripheral systolic (-1.8 mmHg;  p  = 0.14) and diastolic (-0.8 mmHg;  p  = 0.003), as well as central diastolic (-1.5 mmHg;  p  = 0.006) pressure compared to the resting value before the exercise. After the EX, there was a significant decrease in peripheral systolic (-6.3 mmHg;  p  < 0.001) and diastolic (-4.8 mmHg;  p  < 0.001), as well as central systolic (-5.8 mmHg;  p  < 0.001) and diastolic (-5.3 mmHg;  p  < 0.001) pressure compared to baseline. The interaction effects showed significant differences in peripheral and central systolic BP as well as in peripheral diastolic BP ( p  = 0.05). The EX seems to be an effective training approach that triggers relevant peripheral and central BP-responses, which are more pronounced than after a typical ET. Therefore, the ExerCube can be a time-efficient training tool to improve cardiovascular health.",2022,"After the EX, there was a significant decrease in peripheral systolic (-6.3 mmHg;  p  < 0.001) and diastolic (-4.8 mmHg;  p  < 0.001), as well as central systolic (-5.8 mmHg;  p  < 0.001) and diastolic (-5.3 mmHg;  p  < 0.001) pressure compared to baseline.",['Twenty-eight healthy recreational active participants (13 women; aged 24.8 ± 3.9 years'],"['exergaming session (EX', 'Endurance Exercise and Exergaming']","['peripheral and central BP', 'central diastolic', 'peripheral diastolic BP', 'blood pressure (BP) responses', 'central systolic', 'peripheral systolic', 'acute hemodynamic responses', 'diastolic', 'peripheral and central systolic BP']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",28.0,0.0107429,"After the EX, there was a significant decrease in peripheral systolic (-6.3 mmHg;  p  < 0.001) and diastolic (-4.8 mmHg;  p  < 0.001), as well as central systolic (-5.8 mmHg;  p  < 0.001) and diastolic (-5.3 mmHg;  p  < 0.001) pressure compared to baseline.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kircher', 'Affiliation': 'Department of Medical Sciences, Charité University Medicine Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Ketelhut', 'Affiliation': 'Institute of Sport Science, Martin Luther University Halle-Wittenberg, 06120 Halle (Saale), Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Ketelhut', 'Affiliation': 'Faculty of Natural Science, MSB Medical School Berlin, 14197 Berlin, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Röglin', 'Affiliation': 'Institute of Sport Science, Martin Luther University Halle-Wittenberg, 06120 Halle (Saale), Germany.'}, {'ForeName': 'Kuno', 'Initials': 'K', 'LastName': 'Hottenrott', 'Affiliation': 'Institute of Sport Science, Martin Luther University Halle-Wittenberg, 06120 Halle (Saale), Germany.'}, {'ForeName': 'Anna Lisa', 'Initials': 'AL', 'LastName': 'Martin-Niedecken', 'Affiliation': 'Department of Design, Institute for Design Research, Zurich University of the Arts, 8031 Zurich, Switzerland.'}, {'ForeName': 'Reinhard G', 'Initials': 'RG', 'LastName': 'Ketelhut', 'Affiliation': 'Department of Medical Sciences, Charité University Medicine Berlin, 10117 Berlin, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph19031349']
2098,35162346,The Assessment of Prolonged Inferior Alveolar Nerve Blockade for Postoperative Analgesia in Mandibular Third Molar Surgery by a Perineural Addition of Dexamethasone to 0.5% Ropivacaine: A Randomized Comparison Study.,"Background:  Perineurally adding dexamethasone to local anesthetics could enable postoperative analgesia. Our aim was to investigate the efficacy of 4 mg dexamethasone and 0.5% ropivacaine on the prolonged duration of mandibular anesthesia for postoperative analgesia during third molar surgery.  Materials and method:  The patients of both sexes, and in the age range of 17 to 50 yrs of age, received the Gow-Gates anesthesia. Group I received 4 mL of plain 0.5% ropivacaine, with perineurally added 1 mL/4 mg of dexamethasone; group II received 4 mL of plain 0.5% ropivacaine with perineurally added 1 mL of 0.9% saline; group III received 4 mL of plain 0.5 bupivacaine with perineurally added 1 mL of 0.9% saline. The prime anesthesia outcome was the duration of conduction anesthesia (DCA); the secondary outcome was the duration of analgesia (DAN) and analgesia before analgesic intake.  Results:  In 45 randomly selected subjects (mean age 27.06 ± 8.20), DCA was statistically longest in group I ( n  = 15) (592.50 ± 161.75 min,  p  = 0.001), collated with groups II ( n  = 15) and III ( n  = 15) (307.40 ± 84.71 and 367.07 ± 170.52 min, respectively). DAN was significantly the longest in group I (mean: 654.9 ± 198.4 min,  p  = 0.001), compared with group II (345.4 ± 88.0 min) and group III (413.7 ± 152.3 min), with insignificant adverse reactions. One-third of the operated patients absented from the use of analgesics.  Conclusion:  A amount 0.5% ropivacaine with dexamethasone usefully served as an analgesic with a success rate of 93.4% of the given anesthesia.",2022,DAN was significantly the longest in group,"['mandibular anesthesia for postoperative analgesia during third molar surgery', 'patients of both sexes, and in the age range of 17 to 50 yrs of age, received the Gow-Gates anesthesia']","['dexamethasone', 'Dexamethasone', 'ropivacaine', 'plain 0.5% ropivacaine with perineurally added 1 mL of 0.9% saline; group III received 4 mL of plain 0.5 bupivacaine with perineurally added 1 mL of 0.9% saline', '4 mL of plain 0.5% ropivacaine', 'Ropivacaine']","['DAN', 'postoperative analgesia', 'duration of analgesia (DAN) and analgesia before analgesic intake', 'success rate', 'duration of conduction anesthesia (DCA']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0037501', 'cui_str': 'Sodium Dichloroacetate'}]",45.0,0.0978386,DAN was significantly the longest in group,"[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Stojanović', 'Affiliation': 'Department of Oral Surgery, School of Medicine and Stomatology, University of Niš, 18101 Niš, Serbia.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Burić', 'Affiliation': 'Department of Oral Surgery, School of Medicine and Stomatology, University of Niš, 18101 Niš, Serbia.'}, {'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Tijanić', 'Affiliation': 'Department of Oral Surgery, School of Medicine and Stomatology, University of Niš, 18101 Niš, Serbia.'}, {'ForeName': 'Kosta', 'Initials': 'K', 'LastName': 'Todorović', 'Affiliation': 'Department of Oral Surgery, School of Medicine and Stomatology, University of Niš, 18101 Niš, Serbia.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Burić', 'Affiliation': 'School of Medicine, University of Niš, 18101 Niš, Serbia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Burić', 'Affiliation': 'School of Medicine, University of Niš, 18101 Niš, Serbia.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Jovanović', 'Affiliation': 'School of Medicine, University of Niš, 18101 Niš, Serbia.'}, {'ForeName': 'Vukadin', 'Initials': 'V', 'LastName': 'Bajagić', 'Affiliation': 'School of Medicine, University of Podgorica, 81110 Podgorica, Montenegro.'}]",International journal of environmental research and public health,['10.3390/ijerph19031324']
2099,35162608,"Effectiveness of a Tailored Fall-Prevention Program for Discharged Older Patients: A Multicenter, Preliminary, Randomized Controlled Trial.","This multicenter, preliminary, randomized controlled trial investigated the effect of a tailored fall-prevention program using home floor plans for discharged orthopedic patients aged ≥65 years who experienced ≥1 fall(s) in the past year ( n  = 72) at five acute-care hospitals. The control group received standard care (exercise to prevent recurrent falls), whereas the intervention group received a tailored fall-prevention program in addition to usual care. A physical therapist conducted the tailored education program using each patient's home floor plans before discharge. A follow-up survey of falls and near-falls at home was performed using a monthly fall calendar for the 1-month period after discharge. Data on 81.5% of participants remained for the final analyses. No falls occurred in the intervention group; however, 4.3% of those in the control group experienced a fall. Near-falls were reported by 3.7% and 26.9% of the participants in the intervention and control groups, respectively. The proportion of participants who did not experience near-falls in the 1st month after discharge was lower in the intervention than in the control group ( p  = 0.018). In conclusion, the tailored fall-prevention program using home floor plans in multiple acute-care hospitals was effective in reducing falls and near-falls in discharged orthopedic patients.",2022,The proportion of participants who did not experience near-falls in the 1st month after discharge was lower in the intervention than in the control group ( p  = 0.018).,"['discharged orthopedic patients aged ≥65 years who experienced ≥1 fall(s) in the past year ( n  = 72) at five acute-care hospitals', 'Discharged Older Patients', 'discharged orthopedic patients']","['Tailored Fall-Prevention Program', 'tailored fall-prevention program', 'standard care (exercise to prevent recurrent falls), whereas the intervention group received a tailored fall-prevention program in addition to usual care']",['falls and near-falls'],"[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}]",,0.0132434,The proportion of participants who did not experience near-falls in the 1st month after discharge was lower in the intervention than in the control group ( p  = 0.018).,"[{'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, Habikino City 583-8555, Osaka, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Higuchi', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, Habikino City 583-8555, Osaka, Japan.'}, {'ForeName': 'Gentoku', 'Initials': 'G', 'LastName': 'Hattori', 'Affiliation': 'Department of Rehabilitation, Yao Tokushukai General Hospital, Yao City 581-0011, Osaka, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Nomura', 'Affiliation': 'Department of Rehabilitation, Yao Tokushukai General Hospital, Yao City 581-0011, Osaka, Japan.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Rehabilitation, Chiba-Nishi General Hospital, Matsudo City 270-2251, Chiba, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Hosaka', 'Affiliation': 'Department of Rehabilitation, Hanyu General Hospital, Hanyu City 348-8505, Saitama, Japan.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Rehabilitation, Shonan Fujisawa Tokushukai Hospital, Fujisawa City 251-0041, Kanagawa, Japan.'}, {'ForeName': 'Takato', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'Department of Rehabilitation, Uji Tokushukai Medical Center, Uji City 611-0041, Kyoto, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Fukumoto', 'Affiliation': 'Department of Rehabilitation, Nozaki Tokushukai Hospital, Daito City 574-0074, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nemoto', 'Affiliation': 'Department of Rehabilitation, Shonan Kamakura General Hospital, Kamakura City 247-8533, Kanagawa, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph19031585']
2100,35162924,The Effect of Core Stabilization Exercise with the Abdominal Drawing-in Maneuver Technique on Stature Change during Prolonged Sitting in Sedentary Workers with Chronic Low Back Pain.,"To enhance stature recovery, lumbar spine stabilization by stimulating the deep trunk muscle activation for compensation forces originating from the upper body was introduced. The abdominal drawing-in maneuver (ADIM) technique has been found mainly to activate deep trunk muscles. The purpose of the current study was to determine whether 5 weeks of training of deep trunk muscles using the ADIM technique could improve stature recovery, delay trunk muscle fatigue, and decrease pain intensity during prolonged sitting. Thirty participants with chronic low back pain (CLBP) conducted a core stabilization exercise (CSE) with the ADIM technique for 5 weeks. Participants were required to sit for 41 min before and after the exercise intervention. Stature change was measured using a seated stadiometer with a resolution of ±0.006 mm. During sitting, the stature change, pain intensity, and trunk muscle fatigue were recorded. A comparison between measurements at baseline and after 5 weeks of training demonstrated: (i) stature recovery and pain intensity significantly improved throughout the 41 min sitting condition; (ii) the bilaterally trunk muscle showed significantly decreased fatigue. The CSE with the ADIM technique was shown to provide a protective effect on detrimental reductions in stature change and trunk muscle fatigue during prolonged sitting in young participants under controlled conditions in a laboratory. This information may help to prevent the risk of LBP from prolonged sitting activities in real life situations.",2022,The CSE with the ADIM technique was shown to provide a protective effect on detrimental reductions in stature change and trunk muscle fatigue during prolonged sitting in young participants under controlled conditions in a laboratory.,"['Thirty participants with chronic low back pain (CLBP) conducted a', 'Sedentary Workers with Chronic Low Back Pain']","['core stabilization exercise (CSE) with the ADIM technique', 'Core Stabilization Exercise with the Abdominal Drawing-in Maneuver Technique']","['stature recovery and pain intensity', 'stature change and trunk muscle fatigue', 'stature change, pain intensity, and trunk muscle fatigue', 'Stature change', 'stature recovery, delay trunk muscle fatigue, and decrease pain intensity', 'fatigue']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",30.0,0.0554081,The CSE with the ADIM technique was shown to provide a protective effect on detrimental reductions in stature change and trunk muscle fatigue during prolonged sitting in young participants under controlled conditions in a laboratory.,"[{'ForeName': 'Pongsatorn', 'Initials': 'P', 'LastName': 'Saiklang', 'Affiliation': 'Division of Physical Therapy, Faculty of Physical Therapy, Srinakharinwiroj University, Nakhonnayok 26120, Thailand.'}, {'ForeName': 'Rungthip', 'Initials': 'R', 'LastName': 'Puntumetakul', 'Affiliation': 'Research Center of Back, Neck, Other Joint Pain and Human Performance (BNOJPH), Khon Kaen University, Khon Kaen 40002, Thailand.'}, {'ForeName': 'Thiwaphon', 'Initials': 'T', 'LastName': 'Chatprem', 'Affiliation': 'Research Center of Back, Neck, Other Joint Pain and Human Performance (BNOJPH), Khon Kaen University, Khon Kaen 40002, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph19031904']
2101,35162896,Environmental Physical Activity Cues and Children's Active vs. Sedentary Recreation.,"Physical activity (PA) benefits health, and intensive environmental modifications can increase children's PA. Research has not yet addressed if subtle environmental cues, such as posters depicting PA, increase child PA. In the current study, it was hypothesized that children exposed to active posters (vs. nature posters) would spend a larger proportion of free play time engaging with active toys (relative to sedentary toys). Participants were randomly assigned to one of two conditions in which posters on a laboratory wall depicted 1. People being active, or 2. Nature scenes. Children aged 5-10 years (N = 175) could play with up to eight toys (four active, four sedentary) while parents completed study-related surveys. The proportion of playtime that was active was compared between groups. Poster type did not have a significant effect on proportion of active playtime. Previous environmental interventions that increase children's PA have done so through enhancing access to active opportunities, rather than via signage. It is possible that poster interventions such as this may not influence children's PA, or perhaps other types of cues would have been more effective. Future research should investigate subtle environmental cues that match both the target audience and the accessible PA options (e.g., posters depicting children playing with available active toys) and explore other low-investment environmental modifications to boost children's PA.",2022,Poster type did not have a significant effect on proportion of active playtime.,"['Children aged 5-10 years (N = 175) could play with up to eight toys (four active, four sedentary) while parents completed study-related surveys', ""Children's Active vs. Sedentary Recreation""]",[],['proportion of active playtime'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0040565', 'cui_str': 'Toy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}]",[],"[{'cui': 'C0205177', 'cui_str': 'Active'}]",175.0,0.0202871,Poster type did not have a significant effect on proportion of active playtime.,"[{'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Spitzer', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Oselinsky', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Rachel G', 'Initials': 'RG', 'LastName': 'Lucas-Thompson', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Graham', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO 80523, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph19031874']
2102,35162891,The Effects of Acupressure on Improving Health and Reducing Cost for Patients Undergoing Thoracoscopic Surgery.,"OBJECTIVES


This study aimed to assess the effectiveness of practicing acupressure on the Shenmen and Neiguan acupoints with a view to reduce anxiety and improve the comfort and physical health of patients undergoing thoracoscopic surgery.
METHODS


A total of 100 hospitalized patients undergoing thoracoscopic surgery were assigned randomly into the experimental ( n  = 49) and control groups ( n  = 51). Subjects in the experimental group received routine care plus acupressure on the Shenmen and Neiguan acupoints, while those in the control group received regular routine care. The data were collected using demographic information, physical and surgical data, the Visual Analog Scale (VAS)-A, the State-Trait Anxiety Inventory Y Form (STAI-Y1), and Shortened General Comfort Questionnaire scores. The linear mixed model was used to examine the influences of acupressure on VAS-A and STAI-Y1 scores at different time points before and after the surgery to observe group-by-time interactions.
RESULTS


The mean age of the subjects was 60.97 years. All subjects had mild-to-moderate anxiety after surgery and showed a statistically significant decline in regression coefficients on the first and second days after the intervention (β = -11.61,  p  = 0.002; β = -18.71,  p  < 0.001). Similarly, for STAI-YI scores, the data showed a significant difference in the pre-test and post-test interactions between the two groups (β = 4.72,  p  = 0.031). Conversely, acupressure did not have a statistically significant difference on comfort (F = 2.953,  p  = 0.057). Compared with the control subjects, the experimental subjects used less morphine and developed side effects less frequently ( p  < 0.01). They were also able to get out of bed after surgery 163.79 min earlier ( p  < 0.05).
CONCLUSIONS


Acupressure is a simple and easy-to-practice treatment. Acupressure on the Shenmen and Neiguan acupoints reduces anxiety and improves recovery in patients after undergoing thoracoscopic surgery.",2022,"They were also able to get out of bed after surgery 163.79 min earlier ( p  < 0.05).
","['patients undergoing thoracoscopic surgery', 'Patients Undergoing Thoracoscopic Surgery', 'patients after undergoing thoracoscopic surgery', '100 hospitalized patients undergoing thoracoscopic surgery']","['morphine', 'Acupressure', 'routine care plus acupressure on the Shenmen and Neiguan acupoints, while those in the control group received regular routine care', 'practicing acupressure', 'Shenmen and Neiguan acupoints']","['demographic information, physical and surgical data, the Visual Analog Scale (VAS)-A, the State-Trait Anxiety Inventory Y Form (STAI-Y1), and Shortened General Comfort Questionnaire scores', 'regression coefficients', 'comfort and physical health', 'Improving Health and Reducing Cost', 'comfort', 'VAS-A and STAI-Y1 scores', 'anxiety', 'pre-test and post-test interactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0078085', 'cui_str': 'argipressin, Asu(1,6)-'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",100.0,0.0434842,"They were also able to get out of bed after surgery 163.79 min earlier ( p  < 0.05).
","[{'ForeName': 'Hsing-Chi', 'Initials': 'HC', 'LastName': 'Hsu', 'Affiliation': 'Department of Nursing, Hungkuang University, Taichung 433304, Taiwan.'}, {'ForeName': 'Kai-Yu', 'Initials': 'KY', 'LastName': 'Tseng', 'Affiliation': 'Department of Nursing, Central Taiwan University of Science and Technology, Taichung 406053, Taiwan.'}, {'ForeName': 'Hsin-Yuan', 'Initials': 'HY', 'LastName': 'Fang', 'Affiliation': 'School of Medicine, China Medical University, Taichung 406040, Taiwan.'}, {'ForeName': 'Tzu-Min', 'Initials': 'TM', 'LastName': 'Huang', 'Affiliation': 'Department of Surgery, China Medical University Hospital, Taichung 406040, Taiwan.'}, {'ForeName': 'Chi-Chung', 'Initials': 'CC', 'LastName': 'Kuo', 'Affiliation': 'Department of Neurology, Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taichung 427213, Taiwan.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, College of Health Care, China Medical University, Taichung 406040, Taiwan.'}, {'ForeName': 'Wei-Fen', 'Initials': 'WF', 'LastName': 'Ma', 'Affiliation': 'School of Nursing, College of Health Care, China Medical University, Taichung 406040, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph19031869']
2103,35165274,"Clinical and biomarker analyses of sintilimab versus chemotherapy as second-line therapy for advanced or metastatic esophageal squamous cell carcinoma: a randomized, open-label phase 2 study (ORIENT-2).","This randomized, open-label, multi-center phase 2 study (NCT03116152) assessed sintilimab, a PD-1 inhibitor, versus chemotherapy in patients with esophageal squamous cell carcinoma after first-line chemotherapy. The primary endpoint was overall survival (OS), while exploratory endpoint was the association of biomarkers with efficacy. The median OS in the sintilimab group was significantly improved compared with the chemotherapy group (median OS 7.2 vs.6.2 months; P = 0.032; HR = 0.70; 95% CI, 0.50-0.97). Incidence of treatment-related adverse events of grade 3-5 was lower with sintilimab than with chemotherapy (20.2 vs. 39.1%). Patients with high T-cell receptor (TCR) clonality and low molecular tumor burden index (mTBI) showed the longest median OS (15.0 months). Patients with NLR < 3 at 6 weeks post-treatment had a significantly prolonged median OS (16.6 months) compared with NLR ≥ 3. The results demonstrate a significant improvement in OS of sintilimab compared to chemotherapy as second-line treatment for advanced or metastatic ESCC.",2022,"The median OS in the sintilimab group was significantly improved compared with the chemotherapy group (median OS 7.2 vs.6.2 months; P = 0.032; HR = 0.70; 95% CI, 0.50-0.97).","['patients with esophageal squamous cell carcinoma after first-line chemotherapy', 'advanced or metastatic esophageal squamous cell carcinoma']",['sintilimab versus chemotherapy'],"['overall survival (OS', 'prolonged median OS', 'median OS', 'OS of sintilimab']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1142025', 'cui_str': 'Oesophageal squamous cell carcinoma stage IV'}]","[{'cui': 'C4760864', 'cui_str': 'sintilimab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4760864', 'cui_str': 'sintilimab'}]",,0.0789995,"The median OS in the sintilimab group was significantly improved compared with the chemotherapy group (median OS 7.2 vs.6.2 months; P = 0.032; HR = 0.70; 95% CI, 0.50-0.97).","[{'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China. jmxu2003@yahoo.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Qingxia', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Radiotherapy, Nantong Tumor Hospital, Nantong, China.'}, {'ForeName': 'Tongjian', 'Initials': 'T', 'LastName': 'Cui', 'Affiliation': 'Department of Medical Oncology, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Kangsheng', 'Initials': 'K', 'LastName': 'Gu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tao', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Xiuwen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Chemotherapy, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Chengxu', 'Initials': 'C', 'LastName': 'Cui', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Juxiang', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': ""Department of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Quanli', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Immunotherapy, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Cancer Center, Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Cancer Center, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Guanghai', 'Initials': 'G', 'LastName': 'Dai', 'Affiliation': ""Department of Oncology, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': ""Department of Gastrointestinal Oncology, Guangdong Provincial People's Hospital, Guangzhou, China.""}, {'ForeName': 'Jingdong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Liaoning Cancer Hospital, Shenyang, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yunchao', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Thoracic Surgery I, Yunnan Cancer Hospital, Kunming, China.'}, {'ForeName': 'Wangjun', 'Initials': 'W', 'LastName': 'Liao', 'Affiliation': 'Department of Oncology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Departmentof Thoracic Medical Oncology, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, No. 900 Hospital of The Joint Logistic Support Force, Fuzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Oncology, Gansu Provincial Cancer Hospital, Lanzhou, China.'}, {'ForeName': 'Junye', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Jining Medical University, Jining, China.'}, {'ForeName': 'Shoujian', 'Initials': 'S', 'LastName': 'Ji', 'Affiliation': 'Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Innovent Biologics, Inc., Suzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Innovent Biologics, Inc., Suzhou, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Innovent Biologics, Inc., Suzhou, China.'}, {'ForeName': 'Yanqi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Innovent Biologics, Inc., Suzhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Peng', 'Affiliation': 'Innovent Biologics, Inc., Suzhou, China.'}, {'ForeName': 'Jiya', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Innovent Biologics, Inc., Suzhou, China.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Mancao', 'Affiliation': 'Innovent Biologics, Inc., Suzhou, China.'}]",Nature communications,['10.1038/s41467-022-28408-3']
2104,35165113,"Effect of a brief motivational interview and text message intervention targeting tobacco smoking, alcohol use and medication adherence to improve tuberculosis treatment outcomes in adult patients with tuberculosis: a multicentre, randomised controlled trial of the ProLife programme in South Africa.","OBJECTIVE


To investigate the effectiveness of a complex behavioural intervention, ProLife, on tuberculosis (TB) treatment success, medication adherence, alcohol use and tobacco smoking.
DESIGN


Multicentre, individual, randomised controlled trial where participants were assigned (1:1) to the ProLife intervention or usual care.
SETTING


27 primary care clinics in South Africa.
PARTICIPANTS


574 adults starting treatment for drug-sensitive pulmonary TB who smoked tobacco or reported harmful/hazardous alcohol use.
INTERVENTIONS


The intervention, delivered by lay health workers (LHWs), consisted of three brief motivational interviewing (MI) sessions, augmented with short message service (SMS) messages, targeting medication adherence, alcohol use and tobacco smoking.
OUTCOME MEASURES


The primary outcome was successful versus unsuccessful TB treatment at 6-9 months, from TB records. Secondary outcomes were biochemically confirmed sustained smoking cessation, reduction in the Alcohol Use Disorder Identification Test (AUDIT) score, improved TB and antiretroviral therapy (ART) adherence and ART initiation, each measured at 3 and 6 months by questionnaires; and cure rates in patients who had bacteriology-confirmed TB at baseline, from TB records.
RESULTS


Between 15 November 2018 and 31 August 2019, 574 participants were randomised to receive either the intervention (n=283) or usual care (n=291). TB treatment success rates did not differ significantly between intervention (67.8%) and control (70.1%; OR 0.9, 95% CI 0.64% to 1.27%). There was no evidence of an effect at 3 and 6 months, respectively, on continuous smoking abstinence (OR 0.65, 95% CI 0.37 to 1.14; OR 0.76, 95% CI 0.35 to 1.63), TB medication adherence (OR 1.22, 95% CI 0.52 to 2.87; OR 0.89, 95% CI 0.26 to 3.07), taking ART (OR 0.79, 95% CI 0.38 to 1.65; OR 2.05, 95% CI 0.80 to 5.27) or AUDIT scores (mean score difference 0.55, 95% CI -1.01 to 2.11; -0.04, 95% CI -2.0 to 1.91) and adjusting for baseline values. Cure rates were not significantly higher (OR 1.16, 95% CI 0.83 to 1.63).
CONCLUSIONS


Simultaneous targeting of multiple health risk behaviours with MI and SMS using LHWs may not be an effective approach to improve TB outcomes.
TRIAL REGISTRATION NUMBER


ISRCTN62728852.",2022,"Cure rates were not significantly higher (OR 1.16, 95% CI 0.83 to 1.63).
","['Between 15 November 2018 and 31 August 2019, 574 participants', '27 primary care clinics in South Africa', 'adult patients with tuberculosis', '574 adults starting treatment for drug-sensitive pulmonary TB who smoked tobacco or reported harmful/hazardous alcohol use', 'in South Africa']","['complex behavioural intervention, ProLife', 'lay health workers (LHWs), consisted of three brief motivational interviewing (MI) sessions, augmented with short message service (SMS) messages, targeting medication adherence, alcohol use and tobacco smoking', 'ProLife intervention or usual care', 'brief motivational interview and text message intervention targeting tobacco smoking, alcohol use and medication adherence', 'ProLife programme']","['tuberculosis (TB) treatment success, medication adherence, alcohol use and tobacco smoking', 'successful versus unsuccessful TB treatment', 'taking ART', 'sustained smoking cessation, reduction in the Alcohol Use Disorder Identification Test (AUDIT) score, improved TB and antiretroviral therapy (ART) adherence and ART initiation, each measured at 3 and 6 months by questionnaires; and cure rates', 'TB treatment success rates', 'Cure rates', 'TB medication adherence', 'continuous smoking abstinence']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",574.0,0.281882,"Cure rates were not significantly higher (OR 1.16, 95% CI 0.83 to 1.63).
","[{'ForeName': 'Goedele', 'Initials': 'G', 'LastName': 'Louwagie', 'Affiliation': 'Research, Postgraduate Studies and Innovation, Sefako Makgatho Health Sciences University, Pretoria, South Africa Goedele.louwagie@up.ac.za.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Kanaan', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Neo Keitumetse', 'Initials': 'NK', 'LastName': 'Morojele', 'Affiliation': 'Department of Psychology, University of Johannesburg, Auckland Park, South Africa.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Van Zyl', 'Affiliation': 'Research, Postgraduate Studies and Innovation, Sefako Makgatho Health Sciences University, Pretoria, South Africa.'}, {'ForeName': 'Andrew Stephen', 'Initials': 'AS', 'LastName': 'Moriarty', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York, York, UK.'}, {'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Siddiqi', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York, York, UK.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'School of Health Systems and Public Health, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Noreen Dadirai', 'Initials': 'ND', 'LastName': 'Mdege', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Olufemi Babatunde', 'Initials': 'OB', 'LastName': 'Omole', 'Affiliation': 'Department of Family Medicine, University of the Witwatersrand, Johannesburg-Braamfontein, South Africa.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tumbo', 'Affiliation': 'Department of Family Medicine, Sefako Makgatho Health Sciences University, Pretoria, South Africa.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bachmann', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Olalekan A', 'Initials': 'OA', 'LastName': 'Ayo-Yusuf', 'Affiliation': 'School of Health Systems and Public Health, University of Pretoria, Pretoria, South Africa.'}]",BMJ open,['10.1136/bmjopen-2021-056496']
2105,35166158,Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up.,"BACKGROUND


Preliminary data suggest that psilocybin-assisted treatment produces substantial and rapid antidepressant effects in patients with major depressive disorder (MDD), but little is known about long-term outcomes.
AIMS


This study sought to examine the efficacy and safety of psilocybin through 12 months in participants with moderate to severe MDD who received psilocybin.
METHODS


This randomized, waiting-list controlled study enrolled 27 patients aged 21-75 with moderate to severe unipolar depression (GRID-Hamilton Depression Rating Scale (GRID-HAMD) ⩾ 17). Participants were randomized to an immediate or delayed (8 weeks) treatment condition in which they received two doses of psilocybin with supportive psychotherapy. Twenty-four participants completed both psilocybin sessions and were followed through 12 months following their second dose.
RESULTS


All 24 participants attended all follow-up visits through the 12-month timepoint. Large decreases from baseline in GRID-HAMD scores were observed at 1-, 3-, 6-, and 12-month follow-up (Cohen  d  = 2.3, 2.0, 2.6, and 2.4, respectively). Treatment response (⩾50% reduction in GRID-HAMD score from baseline) and remission were 75% and 58%, respectively, at 12 months. There were no serious adverse events judged to be related to psilocybin in the long-term follow-up period, and no participants reported psilocybin use outside of the context of the study. Participant ratings of personal meaning, spiritual experience, and mystical experience after sessions predicted increased well-being at 12 months, but did not predict improvement in depression.
CONCLUSIONS


These findings demonstrate that the substantial antidepressant effects of psilocybin-assisted therapy may be durable at least through 12 months following acute intervention in some patients.",2022,"There were no serious adverse events judged to be related to psilocybin in the long-term follow-up period, and no participants reported psilocybin use outside of the context of the study.","['major depressive disorder', 'participants with moderate to severe MDD who received psilocybin', 'patients with major depressive disorder (MDD', '27 patients aged 21-75 with moderate to severe unipolar depression (GRID-Hamilton Depression Rating Scale (GRID-HAMD)\u2009⩾\u200917', 'All 24 participants attended all follow-up visits through the 12-month timepoint']","['psilocybin sessions', 'psilocybin with supportive psychotherapy', 'psilocybin-assisted treatment', 'psilocybin', 'psilocybin-assisted therapy']","['Efficacy and safety', 'Participant ratings of personal meaning, spiritual experience, and mystical experience after sessions predicted increased well-being', 'GRID-HAMD score from baseline) and remission', 'efficacy and safety', 'depression', 'GRID-HAMD scores']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",27.0,0.0545691,"There were no serious adverse events judged to be related to psilocybin in the long-term follow-up period, and no participants reported psilocybin use outside of the context of the study.","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Gukasyan', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Alan K', 'Initials': 'AK', 'LastName': 'Davis', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Frederick S', 'Initials': 'FS', 'LastName': 'Barrett', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'Cosimano', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Nathan D', 'Initials': 'ND', 'LastName': 'Sepeda', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Johnson', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Roland R', 'Initials': 'RR', 'LastName': 'Griffiths', 'Affiliation': 'Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/02698811211073759']
2106,34878711,Authors' reply re: Long-term efficacy and complications of a multicentre randomised controlled trial comparing retropubic and transobturator mid-urethral slings: a prospective observational study.,,2022,,[],['retropubic and transobturator mid-urethral slings'],[],[],"[{'cui': 'C0205499', 'cui_str': 'Retropubic approach'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}]",[],,0.0824451,,"[{'ForeName': 'Ifeoma', 'Initials': 'I', 'LastName': 'Offiah', 'Affiliation': 'University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'University Hospital Plymouth NHS Trust, Plymouth, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.17024']
2107,35167388,What Does it Mean to be a Woman? How the Content of Gender Identity May Facilitate Women's Coping with Sexual Harassment.,"Sexual harassment and other forms of gendered discrimination are social psychological phenomena, yet the psychological impact of sexual harassment has rarely been examined through a model which considers the role of diverse  content  of gender identity (i.e. norms). We used an experimental design to investigate how salient norms associated with the social identity of 'women' affect coping with sexual harassment. Participants who identified as women ( N  = 291) were randomly assigned to either a feminist, traditional feminine, or control norm condition, in which the salience of particular norms associated with womanhood was manipulated. Participants completed measures of personal growth (as a proxy for post-traumatic growth), and help-seeking intentions in response to a hypothetical sexual harassment scenario. Participants in the feminist condition reported significantly greater personal growth relative to those in the traditional feminine and control conditions. Participants in both the feminist and traditional feminine conditions reported significantly greater intentions to seek help from formal supports (e.g. primary care doctor), relative to those in the control condition. The findings suggest that the salience of social identities and their content may be valuable resources in promoting recovery following experiences of gendered discrimination and support the role of social identities in influencing post-trauma trajectories.",2022,Participants in the feminist condition reported significantly greater personal growth relative to those in the traditional feminine and control conditions.,['Participants who identified as women ( N  = 291'],"['feminist, traditional feminine, or control norm condition']","['personal growth', 'personal growth relative']","[{'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",291.0,0.0254751,Participants in the feminist condition reported significantly greater personal growth relative to those in the traditional feminine and control conditions.,"[{'ForeName': 'Kate A B', 'Initials': 'KAB', 'LastName': 'Western', 'Affiliation': 'Research School of Psychology, 2219The Australian National University, Canberra, Australia.'}, {'ForeName': 'Tegan', 'Initials': 'T', 'LastName': 'Cruwys', 'Affiliation': 'Research School of Psychology, 2219The Australian National University, Canberra, Australia.'}, {'ForeName': 'Michelle K', 'Initials': 'MK', 'LastName': 'Ryan', 'Affiliation': ""3286The Global Institute for Women's Leadership, The Australian National University, Australia.""}]",Journal of interpersonal violence,['10.1177/08862605211073095']
2108,35168030,"Antihypertensive effect of Equisetum arvense L.: a double-blind, randomized efficacy and safety clinical trial.","BACKGROUND


Equisetum arvense L. (EA) is a traditional phytomedicine used as a diuretic agent worldwide and regulated strictly by European Medicine Agency (EMA) and Brazilian National Health Surveillance Agency (ANVISA). However, few studies evaluating its efficacy and safety have been published and no clinical trial assessing its antihypertensive effect has been reported to date.
PURPOSE


To assess antihypertensive effect, safety and tolerability of EA compared to hydrochlorothiazide (HCTZ).
METHODS


This is a double-blind randomized clinical trial, allocating 58 systemic arterial hypertension (SAH) stage I patients (both sexes, 25-65 years old) into two groups (EA and HCTZ). All patients underwent biochemical and cardiologic checkup prior to and during interventions. The EA standardized dry extract (900 mg/day) or HCTZ (25 mg/day) were administered for 3 months and follow-up visits were conducted every 30 days. Efficacy established goals were systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) decreases ≥ 10.0 mmHg and/or casual blood pressure (CBP) < 140/90 mmHg.
RESULTS


EA treatment demonstrated a significant antihypertensive effect, promoting a mean decrease of SBP and DBP by 12.6 and 8.1 mmHg, respectively, and resulting a CBP mean of 134.0/84.5 mmHg at the end of intervention on the SAH stage I patients (CBP mean of 148.5/95.7 mmHg). There were no significant statistical differences between EA and HCTZ interventions on blood pressure decrease, and before-after treatments regarding to biochemical tests and signs of acute toxicity, renal, hepatic and hematologic alterations. A slight trend but no significant difference were observed between adverse events from EA (3.58%) and HCTZ (4.68%) groups.
CONCLUSION


EA standardized dry extract was successfully applied to the SAH stage I patient treatment, decreasing effectively SBP ad DBP values to the reference normal ranges, and demonstrating a well-tolerability profile similar to HCTZ intervention.",2022,"There were no significant statistical differences between EA and HCTZ interventions on blood pressure decrease, and before-after treatments regarding to biochemical tests and signs of acute toxicity, renal, hepatic and hematologic alterations.","['58 systemic arterial hypertension (SAH) stage I patients (both sexes, 25-65 years old) into two groups (EA and HCTZ']","['hydrochlorothiazide (HCTZ', 'HCTZ', 'Equisetum arvense L', 'EA and HCTZ', 'EA']","['systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) decreases ≥ 10.0\xa0mmHg and/or casual blood pressure (CBP', 'biochemical tests and signs of acute toxicity, renal, hepatic and hematologic alterations', 'SAH stage', 'antihypertensive effect', 'effectively SBP ad DBP values', 'SBP and DBP', 'antihypertensive effect, safety and tolerability', 'blood pressure decrease']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3714522', 'cui_str': 'Equisetum arvense whole extract'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}]","[{'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0331746', 'cui_str': 'Equisetum arvense'}, {'cui': 'C3714522', 'cui_str': 'Equisetum arvense whole extract'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",,0.129582,"There were no significant statistical differences between EA and HCTZ interventions on blood pressure decrease, and before-after treatments regarding to biochemical tests and signs of acute toxicity, renal, hepatic and hematologic alterations.","[{'ForeName': 'Danilo Maciel', 'Initials': 'DM', 'LastName': 'Carneiro', 'Affiliation': 'Hypertension League, School of Medicine, Federal University of Goiás (UFG), Goiânia, Goiás, Brazil; Reference Center in Integrative and Complementary Medicine of the State Health Department of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Thiago Veiga', 'Initials': 'TV', 'LastName': 'Jardim', 'Affiliation': 'Hypertension League, School of Medicine, Federal University of Goiás (UFG), Goiânia, Goiás, Brazil.'}, {'ForeName': 'Ymara Cássia Luciana', 'Initials': 'YCL', 'LastName': 'Araújo', 'Affiliation': 'Hypertension League, School of Medicine, Federal University of Goiás (UFG), Goiânia, Goiás, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Arantes', 'Affiliation': 'Hypertension League, School of Medicine, Federal University of Goiás (UFG), Goiânia, Goiás, Brazil.'}, {'ForeName': 'Andrea Cristina', 'Initials': 'AC', 'LastName': 'de Sousa', 'Affiliation': 'Hypertension League, School of Medicine, Federal University of Goiás (UFG), Goiânia, Goiás, Brazil.'}, {'ForeName': 'Weimar Kunz Sebba', 'Initials': 'WKS', 'LastName': 'Barroso', 'Affiliation': 'Hypertension League, School of Medicine, Federal University of Goiás (UFG), Goiânia, Goiás, Brazil.'}, {'ForeName': 'Ana Luiza Lima', 'Initials': 'ALL', 'LastName': 'Sousa', 'Affiliation': 'Hypertension League, School of Medicine, Federal University of Goiás (UFG), Goiânia, Goiás, Brazil.'}, {'ForeName': 'Alessandro de Carvalho', 'Initials': 'AC', 'LastName': 'Cruz', 'Affiliation': 'NEPET-UFG - Nucleus of Toxicopharmacological Studies and Research, School of Pharmacy, Federal University of Goiás, Goiânia, Goiás, Brazil. Electronic address: alesscruz@yahoo.com.br.'}, {'ForeName': 'Luiz Carlos', 'Initials': 'LC', 'LastName': 'da Cunha', 'Affiliation': 'NEPET-UFG - Nucleus of Toxicopharmacological Studies and Research, School of Pharmacy, Federal University of Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Paulo César Brandão Veiga', 'Initials': 'PCBV', 'LastName': 'Jardim', 'Affiliation': 'Hypertension League, School of Medicine, Federal University of Goiás (UFG), Goiânia, Goiás, Brazil; School of Medicine of UFG. FM/HC/UFG Hypertension League. Goiânia, Goiás, Brazil.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2022.153955']
2109,35168011,Single-session interventions for adolescent anxiety and depression symptoms in Kenya: A cluster-randomized controlled trial.,"OBJECTIVE


Expanding mental healthcare for adolescents in low-income regions is a global health priority. Group interventions delivered by lay-providers may expand treatment options. Brief, positively-focused interventions conveying core concepts of adaptive functioning may help reduce adolescent symptoms of mental illness. In this trial, we tested three such interventions (growth mindset, gratitude, and value affirmation) as separate single-session interventions.
METHOD


Consenting adolescents (N = 895; M age  = 16.00) from two secondary schools in Kenya were randomized by classroom (24 classrooms; M class  = 37.29 students) into single-session interventions: growth (N = 240), gratitude (N = 221), values (N = 244), or an active study-skills control (N = 190). Mixed-effects models controlling for age and gender were used to estimate individual-level intervention effects on anxiety and depression symptoms.
RESULTS


Within the universal sample, the values intervention produced greater reductions in anxiety symptoms than the study-skills control (p < .05; d = 0.31 [0.13-0.50]). Within the clinical sub-sample (N = 299), the values (p < .01; d = 0.49 [0.09-0.89]) and growth interventions (p < .05; d = 0.39 [0.01-0.76]) produced greater reductions in anxiety symptoms. There were no significant effects on depression.
CONCLUSIONS


The values intervention reduced anxiety for the full sample, as did the growth mindset and values interventions for symptomatic youths. Future efforts should examine durability of these effects over time.",2022,"The values intervention reduced anxiety for the full sample, as did the growth mindset and values interventions for symptomatic youths.","['adolescent anxiety and depression symptoms in Kenya', 'Consenting adolescents (N\xa0=\xa0895; M age \xa0=\xa016.00) from two secondary schools in Kenya were randomized by classroom (24 classrooms; M class \xa0=\xa037.29 students) into']","['Single-session interventions', 'single-session interventions: growth (N\xa0=\xa0240), gratitude']","['anxiety symptoms', 'depression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0603979,"The values intervention reduced anxiety for the full sample, as did the growth mindset and values interventions for symptomatic youths.","[{'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Venturo-Conerly', 'Affiliation': 'Shamiri Institute, Nairobi, Kenya; Department of Psychology, Harvard University, Cambridge, MA, USA; Shamiri Institute, Pittsfield, MA, USA. Electronic address: kventuroconerly@g.harvard.edu.'}, {'ForeName': 'Tom L', 'Initials': 'TL', 'LastName': 'Osborn', 'Affiliation': 'Shamiri Institute, Nairobi, Kenya; Department of Psychology, Harvard University, Cambridge, MA, USA; Shamiri Institute, Pittsfield, MA, USA.'}, {'ForeName': 'Rediet', 'Initials': 'R', 'LastName': 'Alemu', 'Affiliation': 'Shamiri Institute, Nairobi, Kenya; Department of Psychology, Harvard University, Cambridge, MA, USA; Shamiri Institute, Pittsfield, MA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Roe', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA, USA; Department of Psychology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gan', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Arango', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Wasil', 'Affiliation': 'Shamiri Institute, Nairobi, Kenya; Shamiri Institute, Pittsfield, MA, USA; Department of Psychology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wasanga', 'Affiliation': 'Department of Psychology, Kenyatta University, Nairobi, Kenya.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Weisz', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2022.104040']
2110,35168010,Towards personalizing cognitive remediation therapy: Examining moderators of response for euthymic people with bipolar disorder.,"BACKGROUND


Recent evidence suggests that cognitive remediation (CR) may reduce cognitive and functional difficulties in people with bipolar disorder (BD). However, there is a limited understanding of whether, and which, pre-treatment factors influence who will benefit from CR and this information could help to develop optimal therapy delivery. We aim to identify and examine baseline factors moderating post-treatment improvement.
METHODS


This is a secondary analysis of data from a randomized controlled trial comparing CR (n = 40) to treatment-as-usual (TAU; n = 40) in euthymic people with BD. Elastic net regression was used to identify patient characteristics and baseline measures associated with post-treatment improvement in cognition, psychosocial functioning, and goal attainment. We then tested the moderating effect of retained variables on each outcome using multivariable linear regression.
RESULTS


Despite lower baseline cognitive performance being associated with greater post-treatment changes in cognition and psychosocial functioning, there was no evidence of treatment response moderation. CR effect on goal attainment was larger for participants with better baseline cognitive performance, but this moderating effect did not reach significance (p = 0.09). Those with more severe baseline subjective cognitive complaints (p = 0.03) and more previously completed psychological therapies (p = 0.02) had also larger gains in goal attainment.
CONCLUSIONS


Treatment benefits in cognition and psychosocial functioning might not be affected by pre-treatment factors and patient characteristics. However, baseline cognition and perceived deficits may influence the effect of CR on achieving recovery goals. Therapy adaptations may be required to exert greater benefits for less responsive patients.",2022,"Those with more severe baseline subjective cognitive complaints (p = 0.03) and more previously completed psychological therapies (p = 0.02) had also larger gains in goal attainment.
","['people with bipolar disorder (BD', 'euthymic people with BD', 'euthymic people with bipolar disorder']","['cognitive remediation (CR', 'personalizing cognitive remediation therapy', 'CR']","['cognition and psychosocial functioning', 'cognition, psychosocial functioning, and goal attainment', 'goal attainment', 'severe baseline subjective cognitive complaints']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]",,0.107126,"Those with more severe baseline subjective cognitive complaints (p = 0.03) and more previously completed psychological therapies (p = 0.02) had also larger gains in goal attainment.
","[{'ForeName': 'Dimosthenis', 'Initials': 'D', 'LastName': 'Tsapekos', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. Electronic address: dimosthenis.tsapekos@kcl.ac.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Strawbridge', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Cella', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; South London & Maudsley NHS Foundation Trust, Maudsley Hospital, London, UK.""}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; South London & Maudsley NHS Foundation Trust, Maudsley Hospital, London, UK.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; South London & Maudsley NHS Foundation Trust, Maudsley Hospital, London, UK.""}]",Behaviour research and therapy,['10.1016/j.brat.2022.104054']
2111,35168972,'Mindfulness Living with Insomnia': an mHealth intervention for individuals with insomnia in China: a study protocol of a randomised controlled trial.,"INTRODUCTION


Insomnia has a remarkably negative effect on the work, quality of life and psychosomatic health of individuals, and imposes a substantial economic burden on society. Mindfulness-based interventions (MBIs) have proven beneficial in the treatment of insomnia. However, the effect of mobile or online-based (mHealth) MBIs requires further verification. This study will evaluate the effectiveness of an mHealth MBI, 'Mindful Living with Insomnia' (MLWI), relative to that of mHealth cognitive behavioural therapy for insomnia (CBT-I).
METHODS AND ANALYSIS


The study is an mHealth, randomised controlled trial. Two hundred and fifty participants will be allocated randomly and equally to either the MLWI or CBT-I group. The intervention will involve 12 sessions over a 6-week course, with 2, 30 min sessions per week. The primary outcomes are sleep quality, severity of insomnia symptoms and sleep activity, according to the Pittsburgh Sleep Quality Index, Insomnia Severity Index and sleep tracker Mi Smart Band, respectively. The secondary outcomes are perceived stress, anxiety, depression and mindfulness. Outcomes will be evaluated at the baseline, end of the intervention period and at the 3-month follow-up. Data analyses will include covariance, regression analysis, χ 2 , t-test and Pearson's correlations. Participants will be recruited from January to June 2022, or until the recruitment process is complete. The follow-up will be completed in December 2022. All trial results should be available by the end of December 2022.
ETHICS AND DISSEMINATION


Full approval for this study has been obtained from the Ethics Committee at The Third Xiangya Hospital, Central South University, Changsha, China (21010). Study results will be disseminated via social media and peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT04806009.",2022,"Insomnia has a remarkably negative effect on the work, quality of life and psychosomatic health of individuals, and imposes a substantial economic burden on society.","['individuals with insomnia in China', 'Ethics Committee at The Third Xiangya Hospital, Central South University, Changsha, China (21010', 'Two hundred and fifty participants', 'Mindfulness Living with Insomnia']","['Mindfulness-based interventions (MBIs', 'MLWI or CBT-I group', 'mHealth intervention']","['sleep quality, severity of insomnia symptoms and sleep activity, according to the Pittsburgh Sleep Quality Index, Insomnia Severity Index and sleep tracker Mi Smart Band, respectively', 'perceived stress, anxiety, depression and mindfulness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",250.0,0.105544,"Insomnia has a remarkably negative effect on the work, quality of life and psychosomatic health of individuals, and imposes a substantial economic burden on society.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Pan', 'Affiliation': 'Department of Clinical Psychology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Bingyu', 'Initials': 'B', 'LastName': 'Tie', 'Affiliation': 'Department of Clinical Psychology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Weichao', 'Initials': 'W', 'LastName': 'Yuwen', 'Affiliation': 'School of Nursing and Healthcare Leadership, University of Washington Tacoma, Tacoma, Washington, USA.'}, {'ForeName': 'Xiaoyou', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Clinical Psychology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Department of Clinical Psychology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Clinical Psychology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Psychiatry, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Luya', 'Initials': 'L', 'LastName': 'Kong', 'Affiliation': 'Psychology of Teaching and Research Section, Ideological and Political Department, Heze Professional College on Household, Heze, Shandong, China.'}, {'ForeName': 'Yutao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Student Affairs, Hunan University of Chinese Medicine, Changsha, Hunan, China.'}, {'ForeName': 'Ziwan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Psychology, Hunan Normal University, Changsha, Hunan, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Pan', 'Affiliation': ""Department of Ophthalmology and Otorhinolaryngology, The Second People's Hospital of Xiangtan City, Xiangtan, Hunan, China.""}, {'ForeName': 'Qiuping', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': 'Department of Clinical Psychology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China tt96@sina.com.'}]",BMJ open,['10.1136/bmjopen-2021-053501']
2112,35168969,Effectiveness of a multifaceted intervention to improve interpersonal skills of physicians in medical consultations (EPECREM): protocol for a randomised controlled trial.,"INTRODUCTION


Interpersonal skills, encompassing communication and empathy, are key components of effective medical consultations. Although many organisations have implemented structured training programmes, limited evidence exists on their effectiveness in improving physician interpersonal skills. This study aims to evaluate the effectiveness of a standardised, multifaceted, interpersonal skills development programme for hospital physicians.
METHODS AND ANALYSIS


This study is a prospective, randomised (with a 1:1 allocation ratio), controlled, open-label, two parallel arm, superiority trial conducted at a single university hospital. Physicians will be randomised to receive either a multifaceted training programme or no intervention. The experimental intervention combines two 4-hour training sessions, dissemination of interactive educational materials, review of video-recorded consultations and individual feedback. The primary outcome measure is the overall 4-Habits Coding Scheme score assessed by two independent raters blinded to the study arm, based on video-recorded consultations, before and after intervention. The secondary outcomes include patient satisfaction, therapeutic alliance, physician self-actualisation and the length of medical consultation.
ETHICS AND DISSEMINATION


The study protocol was approved on 21 October 2020 by the CECIC Rhône-Alpes Auvergne, Clermont-Ferrand, France (IRB 5891). All participants will provide written informed consent. Efforts will be made to release the primary results within 6 to 9 months of study completion, regardless of whether they confirm or deny the research hypothesis.
TRIAL REGISTRATION NUMBER


NCT04703816.",2022,"The experimental intervention combines two 4-hour training sessions, dissemination of interactive educational materials, review of video-recorded consultations and individual feedback.","['21 October 2020 by the CECIC Rhône-Alpes Auvergne, Clermont-Ferrand, France (IRB 5891', 'physicians in medical consultations (EPECREM', 'hospital physicians']","['multifaceted training programme or no intervention', 'multifaceted intervention']","['overall 4-Habits Coding Scheme score', 'patient satisfaction, therapeutic alliance, physician self-actualisation and the length of medical consultation', 'interpersonal skills']","[{'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}]",,0.0707206,"The experimental intervention combines two 4-hour training sessions, dissemination of interactive educational materials, review of video-recorded consultations and individual feedback.","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Bellier', 'Affiliation': ""Computational and Mathematical Biology Team, TIMC-IMAG UMR 5525, CNRS, Université Grenoble Alpes, Saint-Martin-d'Heres, Rhône-Alpes, France abellier@chu-grenoble.fr.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Labarère', 'Affiliation': ""Computational and Mathematical Biology Team, TIMC-IMAG UMR 5525, CNRS, Université Grenoble Alpes, Saint-Martin-d'Heres, Rhône-Alpes, France.""}, {'ForeName': 'Zaza', 'Initials': 'Z', 'LastName': 'Putkaradze', 'Affiliation': ""CIC 1406, INSERM, Université Grenoble Alpes, Saint-Martin-d'Heres, Rhône-Alpes, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cavalie', 'Affiliation': 'Clinical Research Department, CHU Grenoble Alpes, Grenoble, Auvergne-Rhone-Alpes, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Carras', 'Affiliation': 'Clinical Research Department, CHU Grenoble Alpes, Grenoble, Auvergne-Rhone-Alpes, France.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Pelen', 'Affiliation': 'Clinical Research Department, CHU Grenoble Alpes, Grenoble, Auvergne-Rhone-Alpes, France.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Paris', 'Affiliation': ""CIC 1406, INSERM, Université Grenoble Alpes, Saint-Martin-d'Heres, Rhône-Alpes, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Chaffanjon', 'Affiliation': ""Medical School, Université Grenoble Alpes, Saint-Martin-d'Heres, Rhône-Alpes, France.""}]",BMJ open,['10.1136/bmjopen-2021-051600']
2113,35168964,"Healthy food prescription incentive programme for adults with type 2 diabetes who are experiencing food insecurity: protocol for a randomised controlled trial, modelling and implementation studies.","INTRODUCTION


The high cost of many healthy foods poses a challenge to maintaining optimal blood glucose levels for adults with type 2 diabetes mellitus who are experiencing food insecurity, leading to diabetes complications and excess acute care usage and costs. Healthy food prescription programmes may reduce food insecurity and support patients to improve their diet quality, prevent diabetes complications and avoid acute care use. We will use a type 2 hybrid-effectiveness design to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of a healthy food prescription incentive programme for adults experiencing food insecurity and persistent hyperglycaemia. A randomised controlled trial (RCT) will investigate programme effectiveness via impact on glycosylated haemoglobin (primary outcome), food insecurity, diet quality and other clinical and patient-reported outcomes. A modelling study will estimate longer-term programme effectiveness in reducing diabetes-related complications, resource use and costs. An implementation study will examine all RE-AIM domains to understand determinants of effective implementation and reasons behind programme successes and failures.
METHODS AND ANALYSIS


594 adults who are experiencing food insecurity and persistent hyperglycaemia will be randomised to a healthy food prescription incentive (n=297) or a healthy food prescription comparison group (n=297). Both groups will receive a healthy food prescription. The incentive group will additionally receive a weekly incentive (CDN$10.50/household member) to purchase healthy foods in supermarkets for 6 months. Outcomes will be assessed at baseline and follow-up (6 months) in the RCT and analysed using mixed-effects regression. Longer-term outcomes will be modelled using the UK Prospective Diabetes Study outcomes simulation model-2. Implementation processes and outcomes will be continuously measured via quantitative and qualitative data.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the University of Calgary and the University of Alberta. Findings will be disseminated through reports, lay summaries, policy briefs, academic publications and conference presentations.
TRIAL REGISTRATION NUMBER


NCT04725630.
PROTOCOL VERSION


Version 1.1; February 2022.",2022,"Healthy food prescription programmes may reduce food insecurity and support patients to improve their diet quality, prevent diabetes complications and avoid acute care use.","['adults with type 2 diabetes mellitus', 'adults experiencing food insecurity and persistent hyperglycaemia', 'adults with type 2 diabetes who are experiencing food insecurity', 'VERSION\n\n\nVersion 1.1; February 2022', '594 adults who are experiencing food insecurity and persistent hyperglycaemia will be randomised to a healthy food prescription incentive (n=297) or a healthy food prescription comparison group (n=297']","['healthy food prescription incentive programme', 'Healthy food prescription incentive programme', 'weekly incentive (CDN$10.50/household member) to purchase healthy foods in supermarkets for 6 months']","['glycosylated haemoglobin (primary outcome), food insecurity, diet quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",594.0,0.0480191,"Healthy food prescription programmes may reduce food insecurity and support patients to improve their diet quality, prevent diabetes complications and avoid acute care use.","[{'ForeName': 'Dana Lee', 'Initials': 'DL', 'LastName': 'Olstad', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada dana.olstad@ucalgary.ca.'}, {'ForeName': 'Reed', 'Initials': 'R', 'LastName': 'Beall', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Eldon', 'Initials': 'E', 'LastName': 'Spackman', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Sharlette', 'Initials': 'S', 'LastName': 'Dunn', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Lorraine L', 'Initials': 'LL', 'LastName': 'Lipscombe', 'Affiliation': ""2Department of Medicine, Women's College Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Kienan', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Indigenous Wellness Core, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Oster', 'Affiliation': 'Department of Agricultural, Food & Nutritional Sciences, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Gabrielle L', 'Initials': 'GL', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'McBrien', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kieran J D', 'Initials': 'KJD', 'LastName': 'Steer', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Catherine B', 'Initials': 'CB', 'LastName': 'Chan', 'Affiliation': 'Department of Agricultural, Food & Nutritional Sciences, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Tyminski', 'Affiliation': 'Nutrition Services, Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Berkowitz', 'Affiliation': 'Division of General Medicine and Clinical Epidemiology, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Gatineau, Quebec, Canada.'}, {'ForeName': 'Alun L', 'Initials': 'AL', 'LastName': 'Edwards', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary Foothills Medical Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Saunders-Smith', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Saania', 'Initials': 'S', 'LastName': 'Tariq', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Popeski', 'Affiliation': 'Diabetes, Obesity and Nutrition Strategic Clinical Network, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'White', 'Affiliation': 'Alberta Region, First Nations and Inuit Health Branch, Indigenous Services Canada, Edmonton, Alberta, Canada.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Williamson', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""L'Abbé"", 'Affiliation': 'Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Raine', 'Affiliation': 'School of Public Health, University of Alberta, 3-300 Edmonton Clinic Health Academy, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Nejatinamini', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Aruba', 'Initials': 'A', 'LastName': 'Naser', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Basualdo-Hammond', 'Affiliation': 'Nutrition Services, Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Norris', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': ""O'Connell"", 'Affiliation': 'Diabetes, Obesity and Nutrition Strategic Clinical Network, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Seidel', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lewanczuk', 'Affiliation': 'Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Calgary, Alberta, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Cabaj', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'David J T', 'Initials': 'DJT', 'LastName': 'Campbell', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}]",BMJ open,['10.1136/bmjopen-2021-050006']
2114,35168963,Effect of a tailored multidimensional intervention on the care burden among family caregivers of stroke survivors: a randomised controlled trial.,"OBJECTIVES


To evaluate the effectiveness of a tailored multidimensional intervention in reducing the care burden of family caregivers of stroke survivors. This intervention considered caregivers' perceived needs and incorporated three evidence-based dimensions (psychoeducation, skill-building and peer support).
DESIGN


A prospective randomised control trial.
SETTING


A community-based study conducted in Egypt.
PARTICIPANTS


A total of 110 caregivers aged ≥18 years who cared for a survivor within 6 months of stroke, with modified Rankin Scale scores of 3-5, and without other physical disabilities or terminal illnesses were recruited between December 2019 and May 2020. Participants were assigned to the intervention group (IG; n=55) and control group (CG; n=55) through open-label, parallel 1:1 randomisation.
INTERVENTION


The IG was provided with tailored multidimensional interventions for 6 months until November 2020, including three home visits, six home-based telephone calls and one peer-support session. The CG received simple educational instructions at a single visit.
OUTCOME


The participants completed the Zarit Burden Interview (primary outcome) and the WHO Quality of Life-BREF (secondary outcome) before the intervention (T0), at 3 months (T1) and at 6 months (T2).
RESULTS


No differences were observed between the characteristics of the groups at baseline (T0). The independent t-test showed no significant differences in the care burden and Quality of Life (QoL) at T1 and T2 between the groups. The intervention had no significant effect on the outcomes between or within groups over time, as shown by the repeated-measures analysis of variance. However, the group and time interaction had significant main effects on caregivers' QoL (psychological and social domains).
CONCLUSION


The main results showed that participants in the IG did not experience an improvement in the main outcomes. Nevertheless, the improvement in the psychological and social domains may have been attributed to our intervention.
TRIAL REGISTRATION NUMBER


NCT04211662.",2022,The independent t-test showed no significant differences in the care burden and Quality of Life (QoL) at T1 and T2 between the groups.,"['family caregivers of stroke survivors', 'A community-based study conducted in Egypt', '110 caregivers aged ≥18 years who cared for a survivor within 6\u2009months of stroke, with modified Rankin Scale scores of 3-5, and without other physical disabilities or terminal illnesses were recruited between December 2019 and May 2020']","['tailored multidimensional intervention', 'control group (CG; n=55) through open-label, parallel 1:1 randomisation', 'three home visits, six home-based telephone calls and one peer-support session']","['care burden and Quality of Life (QoL', ""caregivers' QoL (psychological and social domains"", 'Zarit Burden Interview (primary outcome) and the WHO Quality of Life-BREF']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0679247', 'cui_str': 'Terminal illness'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",110.0,0.136231,The independent t-test showed no significant differences in the care burden and Quality of Life (QoL) at T1 and T2 between the groups.,"[{'ForeName': 'Mahmoud Ahmed', 'Initials': 'MA', 'LastName': 'Elsheikh', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan d194332@hiroshima-u.ac.jp.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Moriyama', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Md Moshiur', 'Initials': 'MM', 'LastName': 'Rahman', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Kako', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Ahmed Hashem', 'Initials': 'AH', 'LastName': 'El-Monshed', 'Affiliation': 'Psychiatric and Mental Health Nursing Department, Faculty of Nursing, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Zoromba', 'Affiliation': 'Psychiatric and Mental Health Nursing Department, Faculty of Nursing, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Hamada', 'Initials': 'H', 'LastName': 'Zehry', 'Affiliation': 'New Mansoura General Hospital, Neurology, Egypt Ministry of Health and Population, Mansoura, Egypt.'}, {'ForeName': 'Maha Hazem', 'Initials': 'MH', 'LastName': 'Khalil', 'Affiliation': 'Neurology, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Abdel-Hady', 'Initials': 'AH', 'LastName': 'El-Gilany', 'Affiliation': 'Public Health, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Amr', 'Affiliation': 'Psychiatry, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",BMJ open,['10.1136/bmjopen-2021-049741']
2115,35169917,Clinical Efficacy Analysis of Augmentation Mammoplasty with Cell-Assisted Autologous Fat Transplantation.,"OBJECTIVE


To analyze the clinical efficacy of augmentation mammoplasty with cell-assisted autologous fat transplantation.
METHODS


Thirty-four cases of micromastia patients in our hospital were randomly divided into control group (n = 17) and observation group (n = 17). Breast augmentation with autologous fat transplantation alone and cell-assisted autologous fat transplantation were performed, respectively, compare and observe the therapeutic effect.
RESULTS


Compared with the control group, the effective rate of breast augmentation was higher in the observation group. After six months of treatment, the increase value of chest circumference (CC), Sternal notch-nipple distance (SN-N),distance between nipple and inframammary fold (N-MF) was higher in the observation group, and the uplift value was higher after six months surgery, with statistical significance (p < 0.05). MRI showed higher postoperative fat retention rate, QLQ-30 Quality of life scores showed no significant difference (p > 0.05).
LEVEL OF EVIDENCE IV


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2022,"MRI showed higher postoperative fat retention rate, QLQ-30 Quality of life scores showed no significant difference (p > 0.05).
",['Thirty-four cases of micromastia patients in our hospital were randomly divided into control group (n = 17) and observation group (n = 17'],"['augmentation mammoplasty with cell-assisted autologous fat transplantation', 'autologous fat transplantation alone and cell-assisted autologous fat transplantation', 'Augmentation Mammoplasty with Cell-Assisted Autologous Fat Transplantation', 'IV']","['increase value of chest circumference (CC), Sternal notch-nipple distance (SN-N),distance between nipple and inframammary fold (N-MF', 'postoperative fat retention rate, QLQ-30 Quality of life scores', 'effective rate of breast augmentation', 'uplift value']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0948473', 'cui_str': 'Micromastia'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C4076692', 'cui_str': 'Autologous fat'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0424683', 'cui_str': 'Chest circumference'}, {'cui': 'C0205316', 'cui_str': 'Notched'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0442099', 'cui_str': 'Inframammary'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}]",34.0,0.0515413,"MRI showed higher postoperative fat retention rate, QLQ-30 Quality of life scores showed no significant difference (p > 0.05).
","[{'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Plastics and Aesthetic Surgery, The Second Xiangya Hospital of Central South University, No.139 Furong Road, Changsha, 410011, Hunan, China.'}, {'ForeName': 'Xiancheng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Plastics and Aesthetic Surgery, The Second Xiangya Hospital of Central South University, No.139 Furong Road, Changsha, 410011, Hunan, China. wangxiancheng64@csu.edu.cn.'}, {'ForeName': 'Conghang', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of Plastics and Aesthetic Surgery, The Second Xiangya Hospital of Central South University, No.139 Furong Road, Changsha, 410011, Hunan, China.'}]",Aesthetic plastic surgery,['10.1007/s00266-022-02778-x']
2116,35170837,Optimised minus lens overcorrection for paediatric intermittent exotropia: A randomised clinical trial.,"BACKGROUND


Aim of this study was to evaluate the efficacy of a novel algorithm to customise overminus lens therapy in intermittent exotropia (IXT) based on clinical factors associated with control of the deviation.
METHODS


Clinical parameters in IXT vary among individuals. Based on individual's physiological factors, an algorithm was developed. Children aged between 4 and 15 years with IXT were randomised into OML and observation groups. Participants in the observation group were corrected for any significant refractive error. IXT control score, angle of deviation, refraction, axial length and stereopsis were examined at baseline and follow up ranging between 6 and 15 months and compared. Compliance and tolerance to OML was determined by a symptom survey.
RESULTS


The OML power ranged between -1.00D and - 6.25D. Of the total 141 participants (mean age 6.8 ± 2.5 year), 77 were in the OML and 66 were in observation group. IXT control score improved (mean difference - 2.5 ± 1.1; p < 0.001) and angle of deviation reduced (6.9 ± 7.2pd; p < 0.001) significantly in the OML group only. Compliance rate to OML wear was 80%; 90% never or rarely experienced asthenopia symptoms. Slightly greater myopic shift (-0.36 ± 0.53D vs. -0.18 ± 0.55D) and change in axial length (0.17 vs. 0.14 mm) were observed in the OML group, but these differences were not statistically significant.
CONCLUSIONS


A customised OML, calculated using this novel algorithm was effective in improving distance control, angle of deviation and stereopsis. Glasses wear was highly tolerable.",2022,IXT control score improved (mean difference - 2.5 ± 1.1; p < 0.001) and angle of deviation reduced (6.9 ± 7.2pd; p < 0.001) significantly in the OML group only.,"['Clinical parameters in IXT vary among individuals', 'Children aged between four and fifteen years with IXT', 'paediatric intermittent exotropia']","['OML', 'novel algorithm to customise overminus lens (OML) therapy']","['Compliance rate to OML wear', 'myopic shift', 'IXT control score, angle of deviation, refraction, axial length and stereopsis', 'axial length', 'IXT control score', 'Compliance and tolerance to OML', 'angle of deviation']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0423062', 'cui_str': 'Intermittent exotropia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0423062', 'cui_str': 'Intermittent exotropia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0011586', 'cui_str': 'Stereoscopic vision'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",141.0,0.150225,IXT control score improved (mean difference - 2.5 ± 1.1; p < 0.001) and angle of deviation reduced (6.9 ± 7.2pd; p < 0.001) significantly in the OML group only.,"[{'ForeName': 'Jit B', 'Initials': 'JB', 'LastName': 'Ale Magar', 'Affiliation': ""Ophthalmology Department, Queensland Children's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Shaheen P', 'Initials': 'SP', 'LastName': 'Shah', 'Affiliation': ""Ophthalmology Department, Queensland Children's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Webber', 'Affiliation': ""Ophthalmology Department, Queensland Children's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Sleep', 'Affiliation': ""Ophthalmology Department, Queensland Children's Hospital, Brisbane, Queensland, Australia.""}, {'ForeName': 'Shuan H', 'Initials': 'SH', 'LastName': 'Dai', 'Affiliation': ""Ophthalmology Department, Queensland Children's Hospital, Brisbane, Queensland, Australia.""}]",Clinical & experimental ophthalmology,['10.1111/ceo.14060']
2117,35171266,Mesenteric SParIng versus extensive mesentereCtomY in primary ileocolic resection for ileocaecal Crohn's disease (SPICY): study protocol for randomized controlled trial.,"BACKGROUND


There is emerging evidence to suggest that Crohn's disease (CD) may be a disease of the mesentery, rather than of the bowel alone. A more extensive mesenteric resection, removing an increased volume of mesentery and lymph nodes to prevent recurrence of CD, may improve clinical outcomes. This study aims to analyse whether more extensive 'oncological' mesenteric resection reduces the recurrence rate of CD.
METHODS


This is an international multicentre randomized controlled study, allocating patients to either group 1-mesenteric sparing ileocolic resection (ICR), the current standard procedure for CD, or group 2-extensive mesenteric ICR, up to the level of the ileocolic trunk. To detect a clinically relevant difference of 25 per cent in endoscopic recurrence at 6 months, a total of 138 patients is required (including 10 per cent dropout). Patients aged over 16 with CD undergoing primary ICR are eligible. Primary outcome is 6-month postoperative endoscopic recurrence rate (modified Rutgeerts score of greater than or equal to i2b). Secondary outcomes are postoperative morbidity, clinical recurrence, quality of life, and the need for (re)starting immunosuppressive medication. For long-term results, patients will be followed up for up to 5 years to determine the reoperation rate for recurrence of disease at the anastomotic site.
CONCLUSION


Analysing these two treatment strategies in a head-to-head comparison will allow an objective evaluation of the clinical relevance of extensive mesenteric resection in CD. If a clinical benefit can be demonstrated, this could result in changes to guidelines which currently recommend close bowel resection.
REGISTRATION NUMBER


NCT00287612 (http://www.clinicaltrials.gov).",2022,Primary outcome is 6-month postoperative endoscopic recurrence rate (modified Rutgeerts score of greater than or equal to i2b).,"[""primary ileocolic resection for ileocaecal Crohn's disease (SPICY"", 'Patients aged over 16 with CD undergoing primary ICR are eligible']","['group 1-mesenteric sparing ileocolic resection (ICR', 'Mesenteric SParIng versus extensive mesentereCtomY']","['6-month postoperative endoscopic recurrence rate (modified Rutgeerts score of greater than or equal to i2b', 'recurrence rate of CD', 'endoscopic recurrence', 'postoperative morbidity, clinical recurrence, quality of life, and the need for (re)starting immunosuppressive medication']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280902', 'cui_str': 'Ileocolic resection'}, {'cui': 'C0700426', 'cui_str': 'Ileocecal'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0025474', 'cui_str': 'Mesenteric'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C1280902', 'cui_str': 'Ileocolic resection'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0198629', 'cui_str': 'Resection of mesentery'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",138.0,0.555573,Primary outcome is 6-month postoperative endoscopic recurrence rate (modified Rutgeerts score of greater than or equal to i2b).,"[{'ForeName': 'E M L', 'Initials': 'EML', 'LastName': 'van der Does de Willebois', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJS open,['10.1093/bjsopen/zrab136']
2118,35171918,Comparison of the effects of empagliflozin and glimepiride on endothelial function in patients with type 2 diabetes: A randomized controlled study.,"Patients with type 2 diabetes who have cardiovascular disease and are receiving empagliflozin have a lower rate of primary composite cardiovascular outcomes. In contrast, glimepiride increases cardiovascular hospitalization when combined with metformin. Here, we assessed the effects of empagliflozin and glimepiride on endothelial function using flow-mediated dilation (FMD). In this prospective, open-label, randomized, parallel-group study, 63 patients with type 2 diabetes received metformin and insulin glargine U100 for 12 weeks. This was followed by additional treatment with empagliflozin or glimepiride for 12 weeks. The primary outcome was the change in the FMD measurement (ΔFMDs) at 24 weeks of additional treatment. Secondary outcomes comprised changes in metabolic markers and body composition. The empagliflozin group (n = 33) and glimepiride group (n = 30) showed no significant differences in ΔFMDs (empagliflozin, -0.11 [95%CI: -1.02, 0.80]%; glimepiride, -0.34 [95%CI: -1.28, 0.60]%; P = 0.73). Additionally, changes in glycated hemoglobin were similar between the two groups. However, a significant difference in body weight change was observed (empagliflozin, -0.58 [95%CI: -1.60, 0.43] kg; glimepiride, 1.20 [95%CI: 0.15, 2.26] kg; P = 0.02). Moreover, a body composition analysis revealed that body fluid volume significantly decreased after empagliflozin treatment (baseline, 35.8 ± 6.8 L; after 12 weeks, -0.33 ± 0.72 L; P = 0.03). Hence, although empagliflozin did not improve endothelial function compared with glimepiride for patients with type 2 diabetes, it did decrease body fluid volumes. Thus, the coronary-protective effect of empagliflozin is not derived from endothelial function protection, but rather from heart failure risk reduction. Trial registration: This trial was registered on September 13, 2016; UMIN000024001.",2022,"However, a significant difference in body weight change was observed (empagliflozin, -0.58","['patients with type 2 diabetes', '63 patients with type 2 diabetes received', 'Patients with type 2 diabetes who have cardiovascular disease and are receiving', 'U100 for 12 weeks', 'September 13, 2016']","['empagliflozin', 'glimepiride', 'metformin', 'metformin and insulin glargine', 'empagliflozin and glimepiride', 'empagliflozin or glimepiride']","['cardiovascular hospitalization', 'ΔFMDs', 'body weight change', 'endothelial function', 'change in the FMD measurement (ΔFMDs', 'glycated hemoglobin', 'changes in metabolic markers and body composition', 'body fluid volume', 'endothelial function using flow-mediated dilation (FMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",63.0,0.15174,"However, a significant difference in body weight change was observed (empagliflozin, -0.58","[{'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Tamura', 'Affiliation': 'Yokohama City University School of Medicine Graduate School of Medicine, Endocrinology and Metabolism, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Chigasaki Municipal Hospital, Endocrinology and Metabolism, Chigasaki, Kanagawa, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Yokohama City University School of Medicine Graduate School of Medicine, Endocrinology and Metabolism, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Hasebe', 'Affiliation': 'Yokohama City University School of Medicine Graduate School of Medicine, Endocrinology and Metabolism, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Shinobu', 'Initials': 'S', 'LastName': 'Satoh', 'Affiliation': 'Chigasaki Municipal Hospital, Endocrinology and Metabolism, Chigasaki, Kanagawa, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Terauchi', 'Affiliation': 'Yokohama City University School of Medicine Graduate School of Medicine, Endocrinology and Metabolism, Yokohama, Kanagawa, Japan.'}]",PloS one,['10.1371/journal.pone.0262831']
2119,35172273,Comparison of StemPrintER with Oncotype DX Recurrence Score for predicting risk of breast cancer distant recurrence after endocrine therapy.,"OBJECTIVE


Molecular tests predicting the risk of distant recurrence (DR) can be used to assist therapy decision-making in oestrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer patients after considerations of standard clinical markers. The Oncotype DX Recurrence Score (RS) is a widespread tool used for this purpose. Here, we compared the RS with the StemPrintER Risk Score (SPRS), a novel genomic predictor with a unique biological basis in its ability to measure the expression of cancer stemness genes.
MATERIALS AND METHODS


We benchmarked the SPRS vs. RS, alone or in combination with clinicopathological variables expressed by the Clinical Treatment Score (CTS), for the prognostication of DR in a retrospective cohort of 776 postmenopausal patients with ER+/HER2-breast cancer enrolled in the translational arm of the randomised Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial. Likelihood ratio (LR) with χ 2  test and C-index were used to assess prognostic performance for the entire ten-year follow-up period and in early (0-5 years) and late (5-10 years) intervals.
RESULTS


In all patients, the SPRS provided significantly more prognostic information than the RS for ten-year DR prognostication (C-index = 0.688, LR-χ 2  = 33.4 vs. C-index = 0.641, LR-χ 2  = 22.1) and for late (5-10 years) DR prognostication (C-index = 0.689, LR-χ 2  = 18.8 vs. C-index = 0.571, LR-χ 2  = 4.7). The SPRS also provided more prognostic information than the RS when added to the CTS in all patients (CTS + SPRS: LR-Δχ 2  = 14.9; CTS + RS: LR-Δχ 2  = 9.7) and in node-negative patients (CTS + SPRS: LR-Δχ 2  = 11.7; CTS + RS: LR-Δχ 2  = 6.6).
CONCLUSIONS


In postmenopausal ER+/HER2- breast cancer patients, SPRS provided more prognostic information than RS for DR when used alone or in combination with the CTS. The SPRS could therefore potentially identify high-risk patients, who might benefit from aggressive treatments, from low-risk patients who might safely avoid adjuvant chemotherapy or prolongation of endocrine therapy.",2022,The SPRS also provided more prognostic information than the RS when added to the CTS in all patients (CTS + SPRS:,"['postmenopausal ER+/HER2- breast cancer patients', '776 postmenopausal patients with ER+/HER2-breast cancer enrolled in the translational arm of the randomised', 'node-negative patients (CTS\xa0+\xa0SPRS']","['StemPrintER with Oncotype DX Recurrence Score', 'Arimidex, Tamoxifen, Alone or in Combination (ATAC', 'endocrine therapy', 'SPRS', 'SPRS vs. RS, alone or in combination with clinicopathological variables expressed by the Clinical Treatment Score (CTS']","['Likelihood ratio (LR', 'Oncotype DX Recurrence Score (RS']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0878174', 'cui_str': 'Arimidex'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",776.0,0.136982,The SPRS also provided more prognostic information than the RS when added to the CTS in all patients (CTS + SPRS:,"[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Pece', 'Affiliation': 'IEO, Istituto Europeo di Oncologia IRCCS, Milan, Italy; Dipartimento di Oncologia e Emato-Oncologia, Università degli Studi di Milano, Milan, Italy. Electronic address: salvatore.pece@ieo.it.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Sestak', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Montani', 'Affiliation': 'IEO, Istituto Europeo di Oncologia IRCCS, Milan, Italy.'}, {'ForeName': 'Micol', 'Initials': 'M', 'LastName': 'Tillhon', 'Affiliation': 'IEO, Istituto Europeo di Oncologia IRCCS, Milan, Italy.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Maisonneuve', 'Affiliation': 'IEO, Istituto Europeo di Oncologia IRCCS, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Freddi', 'Affiliation': 'IEO, Istituto Europeo di Oncologia IRCCS, Milan, Italy.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'IEO, Istituto Europeo di Oncologia IRCCS, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Veronesi', 'Affiliation': 'IEO, Istituto Europeo di Oncologia IRCCS, Milan, Italy; Dipartimento di Oncologia e Emato-Oncologia, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Disalvatore', 'Affiliation': 'IEO, Istituto Europeo di Oncologia IRCCS, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'IEO, Istituto Europeo di Oncologia IRCCS, Milan, Italy; Dipartimento di Oncologia e Emato-Oncologia, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Buus', 'Affiliation': 'The Breast Cancer Now Toby Robins Research Centre at the Institute of Cancer Research, London, UK; Ralph Lauren Centre for Breast Cancer Research, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Cuzick', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': 'The Breast Cancer Now Toby Robins Research Centre at the Institute of Cancer Research, London, UK; Ralph Lauren Centre for Breast Cancer Research, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Pier Paolo', 'Initials': 'PP', 'LastName': 'Di Fiore', 'Affiliation': 'IEO, Istituto Europeo di Oncologia IRCCS, Milan, Italy; Dipartimento di Oncologia e Emato-Oncologia, Università degli Studi di Milano, Milan, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.01.003']
2120,35180222,The surprising power of a click requirement: How click requirements and warnings affect users' willingness to disclose personal information.,"What kinds of information and alerts might cause internet users to be more cautious about what they reveal online? We used a 25-item survey to determine whether the strength of Terms of Service (TOS) warnings and the inclusion of a click requirement affect people's willingness to admit to engaging in inappropriate behaviors. A racially and ethnically diverse group of 1,500 people participated in the study; 98.3% were from the US and India and the remainder from 18 other countries. Participants were randomly assigned to five different groups in which warnings and click requirements varied. In the control condition, no warning was provided. In the four experimental groups, two factors were varied in a 2 × 2 factorial design: strength of warning and click requirement. We found that strong warnings were more effective than weak warnings in decreasing personal disclosures and that click requirements added to the deterrent power of both strong and weak warnings. We also found that a commonly used TOS warning has no impact on disclosures. Participants in the control group provided 32.8% more information than participants in the two click requirement groups combined and 24.3% more information than participants in the four experimental groups combined. The pattern according to which people dropped out of the five different groups sheds further light on the surprising power of the click requirement, as well as on the importance of tracking attrition in online studies.",2022,Participants in the control group provided 32.8% more information than participants in the two click requirement groups combined and 24.3% more information than participants in the four experimental groups combined.,"['A racially and ethnically diverse group of 1,500 people participated in the study; 98.3% were from the US and India and the remainder from 18 other countries']",[],[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205394', 'cui_str': 'Other'}, {'cui': 'C0454664', 'cui_str': 'Country'}]",[],[],1500.0,0.0356665,Participants in the control group provided 32.8% more information than participants in the two click requirement groups combined and 24.3% more information than participants in the four experimental groups combined.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Epstein', 'Affiliation': 'American Institute for Behavioral Research and Technology, Vista, California, United States of America.'}, {'ForeName': 'Vanessa R', 'Initials': 'VR', 'LastName': 'Zankich', 'Affiliation': 'American Institute for Behavioral Research and Technology, Vista, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0263097']
2121,35180213,Superiority of tenofovir alafenamide fumarate over entecavir for serum HBsAg level reduction in patients with chronic HBV infection: A 144-week outcome study after switching of the nucleos(t)ide analog.,"BACKGROUND


To evaluate the long-term efficacy of switching of the nucleos(t)ide analog used for treatment from entecavir (ETV) to tenofovir alafenamide fumarate (TAF) in patients with chronic HBV infection.
METHODS


A total of 103 patients with serum HBsAg levels of ≥100 IU/mL who had received ETV were enrolled. The nucleos(t)ide analog used for the treatment was switched from ETV to TAF, and the changes in serum HBsAg levels during the 144-week period before and after the drug switching were compared in 74 patients who had received ETV at least for 192 weeks.
RESULTS


Significant decreases of serum HBsAg levels were observed during both the ETV and the TAF administration period, although the degree of reduction was greater during the latter period than during the former period (P<0.001). Significant decreases of serum HBsAg levels were seen in both patients with genotype B HBV infection and genotype C HBV infection, irrespective of the serum HBsAg and HBcrAg levels at the time of the drug switching.
CONCLUSION


Switching of the nucleos(t)ide analog used for treatment from ETV to TAF merits consideration in patients with chronic HBV infection, since the extent of reduction of the serum HBsAg level was greater during the TAF treatment period than during the ETV treatment period.",2022,"Significant decreases of serum HBsAg levels were seen in both patients with genotype B HBV infection and genotype C HBV infection, irrespective of the serum HBsAg and HBcrAg levels at the time of the drug switching.
","['103 patients with serum HBsAg levels of ≥100 IU/mL who had received ETV were enrolled', 'patients with chronic HBV infection']","['tenofovir alafenamide fumarate over entecavir', 'entecavir (ETV) to tenofovir alafenamide fumarate (TAF']","['degree of reduction', 'serum HBsAg and HBcrAg levels', 'HBsAg level', 'serum HBsAg levels']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C4058841', 'cui_str': 'Tenofovir alafenamide fumarate'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}]",103.0,0.0231631,"Significant decreases of serum HBsAg levels were seen in both patients with genotype B HBV infection and genotype C HBV infection, irrespective of the serum HBsAg and HBcrAg levels at the time of the drug switching.
","[{'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Uchida', 'Affiliation': 'Faculty of Medicine, Department of Gastroenterology & Hepatology, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Masamitsu', 'Initials': 'M', 'LastName': 'Nakao', 'Affiliation': 'Faculty of Medicine, Department of Gastroenterology & Hepatology, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Faculty of Medicine, Department of Gastroenterology & Hepatology, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Tsuji', 'Affiliation': 'Faculty of Medicine, Department of Gastroenterology & Hepatology, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Faculty of Medicine, Department of Gastroenterology & Hepatology, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Jun-Ichi', 'Initials': 'JI', 'LastName': 'Kouyama', 'Affiliation': 'Faculty of Medicine, Department of Gastroenterology & Hepatology, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Naiki', 'Affiliation': 'Faculty of Medicine, Department of Gastroenterology & Hepatology, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Sugawara', 'Affiliation': 'Faculty of Medicine, Department of Gastroenterology & Hepatology, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Nakayama', 'Affiliation': 'Faculty of Medicine, Department of Gastroenterology & Hepatology, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Imai', 'Affiliation': 'Faculty of Medicine, Department of Gastroenterology & Hepatology, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Tomiya', 'Affiliation': 'Faculty of Medicine, Department of Gastroenterology & Hepatology, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Mochida', 'Affiliation': 'Faculty of Medicine, Department of Gastroenterology & Hepatology, Saitama Medical University, Saitama, Japan.'}]",PloS one,['10.1371/journal.pone.0262764']
2122,35167993,Effects of positive end-expiratory pressure on pulmonary atelectasis after paediatric laparoscopic surgery as assessed by ultrasound: A randomised controlled study.,"INTRODUCTION


Positive end-expiratory pressure (PEEP) following alveolar recruitment manoeuvre (RM) can effectively prevent anaesthesia-induced atelectasis in children. We aimed to evaluate the individual effect of PEEP following RM on atelectasis at the end of laparoscopic surgery in infants and small children.
METHODS


Children undergoing laparoscopic inguinal hernia repair aged 5 weeks to 2 years were randomly allocated to either the PEEP or control group. A progressive RM was performed after intubation in all cases. The PEEP group received PEEP of 5 cmH 2 O until the end of mechanical ventilation, while the control group did not receive any PEEP. Lung ultrasonography was performed to compare the number of atelectatic regions between the two groups after anaesthesia induction, after RM, and at the end of surgery in 12 thoracic regions.
RESULTS


Overall, 432 ultrasonographic images were acquired from 36 children. At the end of surgery, the number of atelectatic regions (median [interquartile range]) was significantly lower in the PEEP group compared to the control group (2.0 [1.0-3.0] versus 4.0 [3.0-4.0] out of 12 regions, respectively; p =  0.02). While no difference was observed between the number of atelectatic regions after induction and at the end of surgery in the control group (p =  0.30), a decrease was observed in the PEEP group (3.0 [2.0-4.0] to 2.0 [1.0-3.0], respectively; p =  0.02).
CONCLUSION


RM followed by a PEEP of 5 cmH 2 O can effectively reduce the regions of pulmonary atelectasis at the end of laparoscopic surgery in infants and small children.",2022,"While no difference was observed between the number of atelectatic regions after induction and at the end of surgery in the control group (p =  0.30), a decrease was observed in the PEEP group (3.0 [2.0 - 4.0] to 2.0 [1.0 - 3.0], respectively; p =  0.02).
","['infants and small children', 'children', 'Children undergoing laparoscopic inguinal hernia repair aged 5 weeks to 2 years']","['Lung ultrasonography', 'PEEP', 'control group did not receive any PEEP', 'PEEP or control group', 'paediatric laparoscopic surgery', 'Positive end-expiratory pressure (PEEP) following alveolar recruitment manoeuvre (RM', 'positive end-expiratory pressure', 'laparoscopic surgery']","['number of atelectatic regions', 'regions of pulmonary atelectasis', 'pulmonary atelectasis']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0203463', 'cui_str': 'Ultrasonography of lung'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439688', 'cui_str': 'Atelectatic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}]",432.0,0.249603,"While no difference was observed between the number of atelectatic regions after induction and at the end of surgery in the control group (p =  0.30), a decrease was observed in the PEEP group (3.0 [2.0 - 4.0] to 2.0 [1.0 - 3.0], respectively; p =  0.02).
","[{'ForeName': 'Hye-Mi', 'Initials': 'HM', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine, Yongin Severance Hospital, 363, Dongbaekjukjeon-daero, Giheung-gu, Yongin-si, Gyeonggi-do, 169995, Republic of Korea; Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea.'}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Min', 'Affiliation': ""Department of Anaesthesiology and Pain Medicine, The Catholic University College of Medicine, Eunpyeong St. Mary's Hospital, 1021, Tongil-ro, Eunpyeong-gu, Seoul 03312, Republic of Korea.""}, {'ForeName': 'Jeong-Rim', 'Initials': 'JR', 'LastName': 'Lee', 'Affiliation': 'Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea; Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea.'}, {'ForeName': 'Min Ho', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea; Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea.'}, {'ForeName': 'Hyo-Jin', 'Initials': 'HJ', 'LastName': 'Byon', 'Affiliation': 'Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea; Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea. Electronic address: JINOBEN@yuhs.ac.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2022.101034']
2123,35169036,"Iberdomide in patients with systemic lupus erythematosus: a randomised, double-blind, placebo-controlled, ascending-dose, phase 2a study.","OBJECTIVE


To evaluate safety, pharmacokinetics, pharmacodynamics and efficacy of iberdomide in patients with SLE. Iberdomide is a high-affinity cereblon ligand that targets the hematopoietic transcription factors Ikaros and Aiolos for proteasomal degradation.
METHODS


A 12-week, multicentre, double-blind, placebo-controlled, dose-escalation study in active SLE was followed by a 2-year, open-label active treatment extension phase (ATEP) (NCT02185040). In the dose-escalation phase, adults with active SLE were randomised to oral placebo or iberdomide (0.3 mg every other day, 0.3 mg once daily, 0.6 mg and 0.3 mg alternating once daily, or 0.6 mg once daily). Primary endpoints were safety and tolerability.
RESULTS


The dose-escalation phase enrolled 42 patients, with 33 completing this phase and 17 patients enrolling into the ATEP. In the dose-escalation phase, the most common treatment-emergent adverse events (TEAEs; iberdomide/placebo groups) were nausea (20.6%/12.5%), diarrhoea (17.6%/12.5%) and upper respiratory tract infection (11.8%/12.5%). Most TEAEs were mild or moderate in severity and more common in the highest dose groups in both study phases. In the dose-escalation phase, Physician's Global Assessment and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity scores improved relative to baseline and placebo in all iberdomide groups, with a trend toward continued score improvements in the ATEP. In the dose-escalation phase, iberdomide treatment resulted in dose-dependent reductions in total B cells and plasmacytoid dendritic cells in blood. Improvements in CLASI activity scores correlated with plasmacytoid dendritic cell depletion.
CONCLUSIONS


These proof-of-concept findings suggest a favourable benefit/risk ratio in SLE for iberdomide, a drug with a novel immunomodulatory mechanism of action, supporting further clinical investigation.",2022,"In the dose-escalation phase, iberdomide treatment resulted in dose-dependent reductions in total B cells and plasmacytoid dendritic cells in blood.","['adults with active SLE', 'patients with systemic lupus erythematosus', '42 patients, with 33 completing this phase and 17 patients enrolling into the ATEP', 'patients with SLE']","['placebo', 'iberdomide', 'oral placebo or iberdomide', 'Iberdomide']","['safety and tolerability', 'CLASI activity scores', 'safety, pharmacokinetics, pharmacodynamics and efficacy', 'nausea', 'upper respiratory tract infection', 'total B cells and plasmacytoid dendritic cells in blood', ""Physician's Global Assessment and Cutaneous Lupus Erythematosus Disease Area and Severity Index"", 'diarrhoea', 'CLASI) activity scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4287813', 'cui_str': 'iberdomide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024137', 'cui_str': 'Cutaneous lupus erythematosus'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C1956385', 'cui_str': 'Dendritic Cells, Plasmacytoid'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",42.0,0.322691,"In the dose-escalation phase, iberdomide treatment resulted in dose-dependent reductions in total B cells and plasmacytoid dendritic cells in blood.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Furie', 'Affiliation': 'Rheumatology, Northwell Health, Great Neck, New York, USA RFurie@northwell.edu.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Hough', 'Affiliation': 'Clinical Research, Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Gaudy', 'Affiliation': 'Translational Development, Clinical Pharmacology, Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'ICF Early Clinical Development, Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Shimon', 'Initials': 'S', 'LastName': 'Korish', 'Affiliation': 'Clinical R&D, Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Nikolay', 'Initials': 'N', 'LastName': 'Delev', 'Affiliation': 'Clinical R&D, Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weiswasser', 'Affiliation': 'Clinical R&D, Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Xiaojiang', 'Initials': 'X', 'LastName': 'Zhan', 'Affiliation': 'Biometrics, Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Schafer', 'Affiliation': 'TRC Inflammation, CV & Fibrosis and Global Health, Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Victoria P', 'Initials': 'VP', 'LastName': 'Werth', 'Affiliation': 'Corporal Michael J Crescenz VA Medical Center, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}]",Lupus science & medicine,['10.1136/lupus-2021-000581']
2124,35168975,Prospective study of preoperative autologous blood donation for patients with high risk of allogeneic blood transfusion in lumbar fusion surgery: a study protocol of a randomised controlled trial.,"INTRODUCTION


Preoperative autologous blood donation (PABD) can be used to reduce the exposure of allogeneic blood transfusion in patients undergoing elective surgery. Better blood management to avoid anaemia and reduce allogeneic blood transfusion after spine surgery become increasingly important with development of enhanced recovery after surgery. We present here the design of a randomised controlled trial with three groups to verify the clinical effectiveness of PABD in patients at high risk of transfusion for lumbar fusion surgery and explore the optimal timing of autologous blood donation.
METHOD AND ANALYSIS


Patients (age 18-70 years) who will receive lumbar fusion surgery for degenerative disease with haemoglobin over 110 g/L and 'high risk' of allogeneic blood transfusion are eligible, unless they refuse participation or are diagnosed with malignant metastases, infection, cardiovascular and cerebrovascular diseases, haematological disorders or relevant drug history and critical illnesses. A total of 1200 patients will be recruited and randomised into three groups. Patients in group A will not receive PABD and be regarded as control group. PABD will be performed for patients in groups B and C. Blood donation will be finished at 1 week (±3 day) before surgery in group B and 2 weeks (±3 day) before surgery in group C. Primary outcome measures will include haemoglobin decline, incidence and amount of allogeneic blood transfusion. Secondary outcome measures will include days of hospitalisation after surgery, haematocrit level and incidence of complications. This study is a single-centre and open-label randomised controlled trial. The sample size is calculated with reference to the retrospective data and previous studies.
ETHICS AND DISSEMINATION


This trial has been approved by the Peking University Third Hospital Medical Science Research Ethic Committee (no: 2020-262-02). Results of the trial will be submitted for publication in a peer-reviewed journal and as conference presentations.
TRIAL REGISTRATION NUMBER


ChiCTR2000039824, preresults.",2022,Better blood management to avoid anaemia and reduce allogeneic blood transfusion after spine surgery become increasingly important with development of enhanced recovery after surgery.,"['patients undergoing elective surgery', '1200 patients', ""Patients (age 18-70 years) who will receive lumbar fusion surgery for degenerative disease with haemoglobin over 110 g/L and 'high risk' of allogeneic blood transfusion are eligible, unless they refuse participation or are diagnosed with malignant metastases, infection, cardiovascular and cerebrovascular diseases, haematological disorders or relevant drug history and critical illnesses"", 'patients at high risk of transfusion for lumbar fusion surgery', 'patients with high risk of allogeneic blood transfusion in lumbar fusion surgery']","['preoperative autologous blood donation', 'Preoperative autologous blood donation (PABD', 'PABD']","['days of hospitalisation after surgery, haematocrit level and incidence of complications', 'haemoglobin decline, incidence and amount of allogeneic blood transfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1285162', 'cui_str': 'Degenerative disorder'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0398307', 'cui_str': 'Blood unit collection for autotransfusion'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",1200.0,0.20206,Better blood management to avoid anaemia and reduce allogeneic blood transfusion after spine surgery become increasingly important with development of enhanced recovery after surgery.,"[{'ForeName': 'Nanfang', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Youyu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Orthopaedics, Peking University Third Hospital, Beijing, China tiany@bjmu.edu.cn.'}, {'ForeName': 'Baohua', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Inpatient Management Center, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Haiqin', 'Initials': 'H', 'LastName': 'Qiao', 'Affiliation': 'Department of Inpatient Management Center, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Blood Transfusion, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Blood Transfusion, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Information Management and Big Data Center, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Information Management and Big Data Center, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Weishi', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Department of General Surgery, Peking University Third Hospital, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2021-053846']
2125,35171260,Comparison of Robot-Assisted and Open Radical Cystectomy in Recovery of Patient-Reported and Performance-Related Measures of Independence: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


No data exist on time to recovery of patient-reported and performance-related measures of functional independence after radical cystectomy (open or robotic).
Objective


To determine recovery of functional independence after radical cystectomy and whether robot-assisted radical cystectomy (RARC) is associated with any advantage over open procedures.
Design, Setting, and Participants


Data for this secondary analysis from the RAZOR (Randomized Open vs Robotic Cystectomy) trial were used. RAZOR was a phase 3 multicenter noninferiority trial across 15 academic medical centers in the US from July 1, 2011, to November 18, 2014, with a median follow-up of 2 years. Participants included the per-protocol population (n = 302). Data were analyzed from February 1, 2017, to May 1, 2021.
Interventions


Robot-assisted radical cystectomy or open radical cystectomy (ORC).
Main Outcomes and Measures


Patient-reported (activities of daily living [ADL] and independent ADL [iADL]) and performance-related (hand grip strength [HGS] and Timed Up & Go walking test [TUGWT]) measures of independence were assessed. Patterns of postoperative recovery for the entire cohort and comparisons between RARC and ORC were performed. Exploratory analyses to assess measures of independence across diversion type and to determine whether baseline impairments were associated with 90-day complications or 1-year mortality were performed.
Findings


Of the 302 patients included in the analysis (254 men [84.1%]; mean [SD] age at consent, 68.0 [9.7] years), 150 underwent RARC and 152 underwent ORC. Baseline characteristics were similar in both groups. For the entire cohort, ADL, iADL, and TUGWT recovered to baseline by 3 postoperative months, whereas HGS recovered by 6 months. There was no difference between RARC and ORC for ADL, iADL, TUGWT, or HGS scores at any time. Activities of daily living recovered 1 month after RARC (mean estimated score, 7.7 [95% CI, 7.3-8.0]) vs 3 months after ORC (mean estimated score, 7.5 [95% CI, 7.2-7.8]). Hand grip strength recovered by 3 months after RARC (mean estimated HGS, 29.0 [95% CI, 26.3-31.7] kg) vs 6 months after ORC (mean estimated HGS, 31.2 [95% CI, 28.8-34.2] kg). In the RARC group, 32 of 90 patients (35.6%) showed a recovery in HGS at 3 months vs 32 of 88 (36.4%) in the ORC group (P = .91), indicating a rejection of the primary study hypothesis for HGS. Independent ADL and TUGWT recovered in 3 months for both approaches. Hand grip strength showed earlier recovery in patients undergoing continent urinary diversion (mean HGS at 3 months, 31.3 [95% CI, 27.7-34.8] vs 33.9 [95% CI, 30.5-37.3] at baseline; P = .09) than noncontinent urinary diversion (mean HGS at 6 months, 27.4 [95% CI, 24.9-30.0] vs 29.5 [95% CI, 27.2-31.9] kg at baseline; P = .02), with no differences in other parameters. Baseline impairments in any parameter were not associated with 90-day complications or 1-year mortality.
Conclusions and Relevance


The results of this secondary analysis suggest that patients require 3 to 6 months to recover baseline levels after radical cystectomy irrespective of surgical approach. These data will be invaluable in patient counseling and preparation. Hand grip strength and ADL tended to recover to baseline earlier after RARC; however, there was no difference in the percentage of patients recovering when compared with ORC. Further study is needed to assess the clinical significance of these findings.
Trial Registration


ClinicalTrials.gov Identifier: NCT01157676.",2022,"There was no difference between RARC and ORC for ADL, iADL, TUGWT, or HGS scores at any time.","['Participants included the per-protocol population (n\u2009=\u2009302', '254 men [84.1%]; mean [SD] age at consent, 68.0 [9.7] years), 150 underwent RARC and 152 underwent ORC', '15 academic medical centers in the US from July 1, 2011, to November 18, 2014, with a median follow-up of 2 years', '302 patients included in the analysis', 'Independence']","['Interventions\n\n\nRobot-assisted radical cystectomy or open radical cystectomy (ORC', 'Robotic Cystectomy', 'radical cystectomy and whether robot-assisted radical cystectomy (RARC', 'radical cystectomy (open or robotic', 'Robot-Assisted and Open Radical Cystectomy', 'RAZOR']","['HGS', '90-day complications or 1-year mortality', 'recovery in HGS', 'RARC and ORC for ADL, iADL, TUGWT, or HGS scores', 'functional independence', 'Hand grip strength', 'Activities of daily living', 'Main Outcomes and Measures\n\n\nPatient-reported (activities of daily living [ADL] and independent ADL [iADL]) and performance-related (hand grip strength [HGS] and Timed Up & Go walking test [TUGWT]) measures of independence']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}, {'cui': 'C0336670', 'cui_str': 'Razor'}]","[{'cui': 'C1568891', 'cui_str': 'HGS protein, human'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.574967,"There was no difference between RARC and ORC for ADL, iADL, TUGWT, or HGS scores at any time.","[{'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Venkatramani', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Isildinha M', 'Initials': 'IM', 'LastName': 'Reis', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Gonzalgo', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Castle', 'Affiliation': 'Department of Urology, Tulane University School of Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Woods', 'Affiliation': 'Department of Urology, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Svatek', 'Affiliation': 'Department of Urology, Division of Urologic Oncology, University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Alon Z', 'Initials': 'AZ', 'LastName': 'Weizer', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Badrinath R', 'Initials': 'BR', 'LastName': 'Konety', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Tollefson', 'Affiliation': 'Department of Urology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Krupski', 'Affiliation': 'Department of Urology, University of Virginia Health Science Center, Charlottesville.'}, {'ForeName': 'Norm D', 'Initials': 'ND', 'LastName': 'Smith', 'Affiliation': 'Department of Urology, North Shore University Health System, Evanston, Illinois.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Shabsigh', 'Affiliation': 'Department of Urology, Ohio State University, Columbus.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Barocas', 'Affiliation': 'Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Marcus L', 'Initials': 'ML', 'LastName': 'Quek', 'Affiliation': 'Department of Urology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Atreya', 'Initials': 'A', 'LastName': 'Dash', 'Affiliation': 'Department of Urology, University of Washington, Seattle.'}, {'ForeName': 'Dipen J', 'Initials': 'DJ', 'LastName': 'Parekh', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.48329']
2126,35171682,Systemic inflammation and metabolic disturbances underlie inpatient mortality among ill children with severe malnutrition.,"Children admitted to hospital with an acute illness and concurrent severe malnutrition [complicated severe malnutrition (CSM)] have a high risk of dying. The biological processes underlying their mortality are poorly understood. In this case-control study nested within a multicenter randomized controlled trial among children with CSM in Kenya and Malawi, we found that blood metabolomic and proteomic profiles robustly differentiated children who died ( n  = 92) from those who survived ( n  = 92). Fatalities were characterized by increased energetic substrates (tricarboxylic acid cycle metabolites), microbial metabolites (e.g., propionate and isobutyrate), acute phase proteins (e.g., calprotectin and C-reactive protein), and inflammatory markers (e.g., interleukin-8 and tumor necrosis factor-α). These perturbations indicated disruptions in mitochondria-related bioenergetic pathways and sepsis-like responses. This study identified specific biomolecular disturbances associated with CSM mortality, revealing that systemic inflammation and bioenergetic deficits are targetable pathophysiological processes for improving survival of this vulnerable population.",2022,"Fatalities were characterized by increased energetic substrates (tricarboxylic acid cycle metabolites), microbial metabolites (e.g., propionate and isobutyrate), acute phase proteins (e.g., calprotectin and C-reactive protein), and inflammatory markers (e.g., interleukin-8 and tumor necrosis factor-α).","['Children admitted to hospital with an acute illness and concurrent severe malnutrition [complicated severe malnutrition (CSM', 'children with CSM in Kenya and Malawi, we found that blood metabolomic and proteomic profiles robustly differentiated children who died ( n  = 92) from those who survived ( n  = 92', 'ill children with severe malnutrition']",[],"['energetic substrates (tricarboxylic acid cycle metabolites), microbial metabolites (e.g., propionate and isobutyrate), acute phase proteins (e.g., calprotectin and C-reactive protein), and inflammatory markers (e.g., interleukin-8 and tumor necrosis factor-α']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}]",[],"[{'cui': 'C0008858', 'cui_str': 'Krebs cycle pathway'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0033474', 'cui_str': 'Propanoates'}, {'cui': 'C0001347', 'cui_str': 'Acute phase reactant'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]",,0.10954,"Fatalities were characterized by increased energetic substrates (tricarboxylic acid cycle metabolites), microbial metabolites (e.g., propionate and isobutyrate), acute phase proteins (e.g., calprotectin and C-reactive protein), and inflammatory markers (e.g., interleukin-8 and tumor necrosis factor-α).","[{'ForeName': 'Bijun', 'Initials': 'B', 'LastName': 'Wen', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Njunge', 'Affiliation': 'The Childhood Acute Illness & Nutrition Network, Nairobi, Kenya.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Bourdon', 'Affiliation': 'Department of Translational medicine, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Gerard Bryan', 'Initials': 'GB', 'LastName': 'Gonzales', 'Affiliation': 'Nutrition, Metabolism and Genomics Group, Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}, {'ForeName': 'Bonface M', 'Initials': 'BM', 'LastName': 'Gichuki', 'Affiliation': 'The Childhood Acute Illness & Nutrition Network, Nairobi, Kenya.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Department of Translational medicine, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Wishart', 'Affiliation': 'The Metabolomics Innovation Centre, Edmonton, Alberta, Canada.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Ngari', 'Affiliation': 'The Childhood Acute Illness & Nutrition Network, Nairobi, Kenya.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Chimwezi', 'Affiliation': 'The Childhood Acute Illness & Nutrition Network, Nairobi, Kenya.'}, {'ForeName': 'Johnstone', 'Initials': 'J', 'LastName': 'Thitiri', 'Affiliation': 'The Childhood Acute Illness & Nutrition Network, Nairobi, Kenya.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mwalekwa', 'Affiliation': 'KEMRI/Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Wieger', 'Initials': 'W', 'LastName': 'Voskuijl', 'Affiliation': 'The Childhood Acute Illness & Nutrition Network, Nairobi, Kenya.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Berkley', 'Affiliation': 'The Childhood Acute Illness & Nutrition Network, Nairobi, Kenya.'}, {'ForeName': 'Robert Hj', 'Initials': 'RH', 'LastName': 'Bandsma', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Canada.'}]",Science advances,['10.1126/sciadv.abj6779']
2127,35172563,Outstanding outcomes in infants with  KMT2A -germline acute lymphoblastic leukemia treated with chemotherapy alone: results of the Children's Oncology Group AALL0631 trial.,Not available.,2022,Not available.,['infants with  KMT2A -germline acute lymphoblastic leukemia treated with'],['chemotherapy alone'],[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1527868', 'cui_str': 'MLL protein, human'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0903374,Not available.,"[{'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Guest', 'Affiliation': ""Division of Hematology/Oncology/Blood and Marrow Transplantation, Children's Mercy Kansas City, Kansas City, MO. eguest@cmh.edu.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kairalla', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine, Public Health and Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Hilden', 'Affiliation': ""Center for Cancer and Blood Disorders, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'ZoAnn E', 'Initials': 'ZE', 'LastName': 'Dreyer', 'Affiliation': ""Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Cindy Y', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine, Public Health and Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Gore', 'Affiliation': ""Center for Cancer and Blood Disorders, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Wanda L', 'Initials': 'WL', 'LastName': 'Salzer', 'Affiliation': 'U.S. Army Medical Research and Materiel Command, Fort Detrick, MD.'}, {'ForeName': 'Naomi J', 'Initials': 'NJ', 'LastName': 'Winick', 'Affiliation': 'Division of Pediatric Hematology/Oncology, University of Texas Southwestern School of Medicine, Dallas, TX.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Department of Pediatrics and Perlmutter Cancer Center, NYU Langone Health, New York, NY.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Raetz', 'Affiliation': 'Department of Pediatrics and Perlmutter Cancer Center, NYU Langone Health, New York, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Borowitz', 'Affiliation': 'Departments of Pathology and Oncology, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Mignon L', 'Initials': 'ML', 'LastName': 'Loh', 'Affiliation': ""Department of Pediatrics, Benioff Children's Hospital in the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics and the Center for Childhood Cancer Research, Children's Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Brown', 'Affiliation': 'Division of Pediatric Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD.'}]",Haematologica,['10.3324/haematol.2021.280146']
2128,35172856,"Actively implementing an evidence-based feeding guideline for critically ill patients (NEED): a multicenter, cluster-randomized, controlled trial.","BACKGROUND


Previous cluster-randomized controlled trials evaluating the impact of implementing evidence-based guidelines for nutrition therapy in critical illness do not consistently demonstrate patient benefits. A large-scale, sufficiently powered study is therefore warranted to ascertain the effects of guideline implementation on patient-centered outcomes.
METHODS


We conducted a multicenter, cluster-randomized, parallel-controlled trial in intensive care units (ICUs) across China. We developed an evidence-based feeding guideline. ICUs randomly allocated to the guideline group formed a local ""intervention team"", which actively implemented the guideline using standardized educational materials, a graphical feeding protocol, and live online education outreach meetings conducted by members of the study management committee. ICUs assigned to the control group remained unaware of the guideline content. All ICUs enrolled patients who were expected to stay in the ICU longer than seven days. The primary outcome was all-cause mortality within 28 days of enrollment.
RESULTS


Forty-eight ICUs were randomized to the guideline group and 49 to the control group. From March 2018 to July 2019, the guideline ICUs enrolled 1399 patients, and the control ICUs enrolled 1373 patients. Implementation of the guideline resulted in significantly earlier EN initiation (1.20 vs. 1.55 mean days to initiation of EN; difference - 0.40 [95% CI - 0.71 to - 0.09]; P = 0.01) and delayed PN initiation (1.29 vs. 0.80 mean days to start of PN; difference 1.06 [95% CI 0.44 to 1.67]; P = 0.001). There was no significant difference in 28-day mortality (14.2% vs. 15.2%; difference - 1.6% [95% CI - 4.3% to 1.2%]; P = 0.42) between groups.
CONCLUSIONS


In this large-scale, multicenter trial, active implementation of an evidence-based feeding guideline reduced the time to commencement of EN and overall PN use but did not translate to a reduction in mortality from critical illness.
TRIAL REGISTRATION


ISRCTN, ISRCTN12233792 . Registered November 20th, 2017.",2022,Implementation of the guideline resulted in significantly earlier EN initiation (1.20 vs. 1.55 mean days to initiation of EN; difference - 0.40 [95% CI - 0.71 to - 0.09]; P = 0.01) and delayed PN initiation (1.29 vs. 0.80 mean days to start of PN; difference 1.06 [95% CI 0.44 to 1.67]; P = 0.001).,"['critically ill patients (NEED', 'From March 2018 to July 2019, the guideline ICUs enrolled 1399 patients, and the control ICUs enrolled 1373 patients', 'Forty-eight ICUs', 'intensive care units (ICUs) across China']","['local ""intervention team"", which actively implemented the guideline using standardized educational materials, a graphical feeding protocol, and live online education outreach meetings']","['delayed PN initiation', '28-day mortality', 'earlier EN initiation', 'cause mortality']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4505477', 'cui_str': 'Online Education'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]","[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",1399.0,0.19963,Implementation of the guideline resulted in significantly earlier EN initiation (1.20 vs. 1.55 mean days to initiation of EN; difference - 0.40 [95% CI - 0.71 to - 0.09]; P = 0.01) and delayed PN initiation (1.29 vs. 0.80 mean days to start of PN; difference 1.06 [95% CI 0.44 to 1.67]; P = 0.001).,"[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Ke', 'Affiliation': 'Department of Critical Care Medicine, Jinling Hospital, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu Province, China.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Critical Care Medicine, Jinling Hospital, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu Province, China.'}, {'ForeName': 'Gordon S', 'Initials': 'GS', 'LastName': 'Doig', 'Affiliation': 'Northern Clinical School, Royal North Shore Hospital, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Arthur R H', 'Initials': 'ARH', 'LastName': 'van Zanten', 'Affiliation': 'Department of Intensive Care Medicine, Gelderse Vallei Hospital, Willy Brandtlaan 10, 6716 RP, Ede, The Netherlands.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Research and Biometrics Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Xing', 'Affiliation': 'Benq Medical Center, Nanjing, China.'}, {'ForeName': 'Zhongheng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency Medicine, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Tropical Clinical Trials Unit, Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, L3 5QA, UK.'}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""First People's Hospital of Foshan, Foshan, China.""}, {'ForeName': 'Dongpo', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Qindong', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': ""First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, China.""}, {'ForeName': 'Jiandong', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Suzhou Municipal Hospital, Suzhou, China.'}, {'ForeName': 'Aibin', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': 'North China University of Science and Technology Affiliated Hospital, Tangshan, China.'}, {'ForeName': 'Yafeng', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Qindao University Medical College Affiliated Yantai Yuhuangding Hospital, Yantai, China.'}, {'ForeName': 'Peiyang', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine Affiliated Hospital, Chengdu, China.'}, {'ForeName': 'Junli', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Luoyang Central Hospital Affiliated To Zhengzhou University, Luoyang, China.'}, {'ForeName': 'Wenming', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Changzhou No. 2 People's Hospital Affiliated to Nanjing Medical University, Changzhou, China.""}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'The Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Rumin', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Zibo Central Hospital, Zibo, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xing', 'Affiliation': 'Department of Intensive Care Medicine, The Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""First People's Hospital of Kunming, Kunming, China.""}, {'ForeName': 'Tingfa', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Linyi City People Hospital, Shandong, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Tangshan Gongren Hospital, Tangshan, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Tong', 'Affiliation': 'Hebei Medical University Second Affiliated Hospital, Shijiazhuang, China.'}, {'ForeName': 'Qiuhui', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Wuxi People's Hospital, Wuxi, China.""}, {'ForeName': 'Aijun', 'Initials': 'A', 'LastName': 'Pan', 'Affiliation': 'Anhui Provincial Hospital, Hefei, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Department of Critical Care Medicine, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, 610072, China.""}, {'ForeName': 'Chuming', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': ""First People's Hospital of Yunnan, Kunming, China.""}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Yijishan Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Dongwu', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': ""Shanxi Provincial People's Hospital, Taiyuan, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Shanxi Medical University First Affiliated Hospital, Taiyuan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""The People's Hospital of Fujian Province, Fuzhou, China.""}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': ""People's Hospital of Yuxi City, Yuxi, China.""}, {'ForeName': 'Yingguang', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': ""Jining First People's Hospital, Jining, China.""}, {'ForeName': 'Rongqing', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Guo', 'Affiliation': 'Department of Critical Care Medicine, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': ""People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.""}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Affiliated Hospital of Inner Mongolia Medical College, Huhehaote, China.'}, {'ForeName': 'Xiangde', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Dazhou Central Hospital, Dazhou, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shan', 'Affiliation': 'Qindao University Medical College Affiliated Hospital, Qindao, China.'}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Inner Mongolia People's Hospital, Huhehaote, China.""}, {'ForeName': 'Yuhang', 'Initials': 'Y', 'LastName': 'Ai', 'Affiliation': 'Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Qu', 'Affiliation': 'Qingdao Municipal Hospital Group, Qingdao, China.'}, {'ForeName': 'Liandi', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Qindao University Medical College Affiliated Hospital, Qindao, China.'}, {'ForeName': 'Hailing', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""No.971 Hospital of People's Liberation Army Navy, Qingdao, China.""}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'General Hospital of Southern Theatre Command, Guangzhou, China.'}, {'ForeName': 'Donglin', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': ""Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, Guangdong, China.""}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Zou', 'Affiliation': 'Union Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'The General Hospital of Shenyang Military, Shenyan, China.'}, {'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ""Jiangxi Provincial People's Hospital, Nanchang, China.""}, {'ForeName': 'Qiuye', 'Initials': 'Q', 'LastName': 'Kou', 'Affiliation': 'The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xijing', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Anaesthesiology and Perioperative Medicine, Xijing Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jinglan', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Shenzhen Nanshan People's Hospital, Shenzhen, China.""}, {'ForeName': 'Chuanyun', 'Initials': 'C', 'LastName': 'Qian', 'Affiliation': 'Kuming Medical University First Affiliated Hospital, Kuming, China.'}, {'ForeName': 'Weixing', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Peking University Shenzhen Hospital, Guandong, China.'}, {'ForeName': 'Minjie', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'General ICU, Jinan University First Affiliated Hospital, Jinan, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zong', 'Affiliation': ""Shaanxi Provincial People's Hospital, Xi'an, China.""}, {'ForeName': 'Bingyu', 'Initials': 'B', 'LastName': 'Qin', 'Affiliation': ""Henan Provincial People's Hospital, Zhengzhou, China.""}, {'ForeName': 'Fusen', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Tai'an City Central Hospital, Tai'an, China.""}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhai', 'Affiliation': 'The Fourth Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Anhui Medical University Second Affiliated Hospital, Hefei, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chang', 'Affiliation': 'Southern Medical University Zhujiang Hospital, Guangzhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Department of Critical Care Medicine, the Second Xiangya Hospital of Central South University, Changsha, 410000, Hunan, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': ""First People's Hospital of Yichang, Yichang, China.""}, {'ForeName': 'Shiying', 'Initials': 'S', 'LastName': 'Yuan', 'Affiliation': 'Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yijun', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': ""Yancheng First People's Hospital, Yancheng, China.""}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zang', 'Affiliation': 'China Medical University Affiliated Shengjing Hospital, Shenyang, China.'}, {'ForeName': 'Yuanfei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Changsha Central Hospital Affiliated to University of South China, Changsha, China.'}, {'ForeName': 'Fachun', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Chongqing Medical University First Affiliated Hospital, Chongqing, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Critical Care Medicine, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Shao', 'Affiliation': 'The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Shanxi Bethune Hospital, Taiyuan, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': ""Health Science Center, The Second People's Hospital of Shenzhen, First Affiliated Hospital of Shenzhen University, Shenzhen, China.""}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Yichang Central People's Hospital, Yichang, China.""}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Hebei Medical University, Third Affiliated Hospital, Shijiazhuang, China.'}, {'ForeName': 'Yuanqi', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'The Second Affiliated Hospital of Nanchang University, Jiangxi, China.'}, {'ForeName': 'Yunlin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'The First Affiliated Hospital of Xinjiang Medical University, Xinjiang, China.'}, {'ForeName': 'Kejian', 'Initials': 'K', 'LastName': 'Qian', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Jiangxi, China.'}, {'ForeName': 'Yongjian', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Neurosurgical ICU, Jinan University First Affiliated Hospital, Jinan, China.'}, {'ForeName': 'Baocai', 'Initials': 'B', 'LastName': 'Fu', 'Affiliation': 'Yantai Mountain Hospital, Yantai, China.'}, {'ForeName': 'Xueyan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Shenzhen People's Hospital, Shenzhen, China.""}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Hunan Provincial People's Hospital, Changsha, China.""}, {'ForeName': 'Chuanyong', 'Initials': 'C', 'LastName': 'Gong', 'Affiliation': 'Tianjing Hospital of Integration of Chinese and Western Medicine, Tianjing, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': ""Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'The Second Hospital of Dalian Medical University, Liaoning, China.'}, {'ForeName': 'Zhongzhi', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'Wuhan General Hospital of Guangzhou Military Region, Wuhan, China.'}, {'ForeName': 'Linxi', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Shantou University Medical College First Affiliated Hospital, Shantou, China.'}, {'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Ma', 'Affiliation': 'Jining Medical College Affiliated Hospital, Jining, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Qingshan', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Hubei Provincial People's Hospital, Wuhan, China.""}, {'ForeName': 'Rongguo', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Fujian Provincial Hospital, Fujian, China.'}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': 'Department of Critical Care Medicine, Jinling Hospital, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu Province, China. njzyantol@hotmail.com.'}, {'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Jinling Hospital, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu Province, China. ctgchina@medbit.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Critical care (London, England)",['10.1186/s13054-022-03921-5']
2129,35173011,Protocol for the Lovisenberg Open Acute Door Study (LOADS): a pragmatic randomised controlled trial to compare safety and coercion between open-door policy and usual-care services in acute psychiatric inpatients.,"INTRODUCTION


The reduction of coercion in psychiatry is a high priority for both the WHO and many member countries. Open-door policy (ODP) is a service model for psychiatric ward treatment that prioritises collaborative and motivational measures to better achieve acute psychiatric safety - and treatment objectives. Keeping the ward main door open is one such measure. Evidence on the impact of ODP on coercion and violent events is mixed, and only one randomised controlled trial (RCT) has previously compared ODP to standard practice. The main objectives of the Lovisenberg Open Acute Door Study (LOADS) are to implement and evaluate a Nordic version of ODP for acute psychiatric inpatient services. The evaluation is designed as a pragmatic RCT with treatment-as-usual (TAU) control followed by a 4-year observational period.
METHODS AND ANALYSIS


In this 12-month pragmatic randomised trial, all patients referred to acute ward care will be randomly allocated to either TAU or ODP wards. The primary outcome is the proportion of patient stays with one or more coercive measures. Secondary outcomes include adverse events involving patients and/or staff, substance use and users' experiences of the treatment environment and of coercion. The main hypothesis is that ODP services will not be inferior to state-of-the art psychiatric treatment. ODP and TAU wards are determined via ward-level randomisation. Following conclusion of the RCT, a longitudinal observational phase begins designed to monitor any long-term effects of ODP.
ETHICS AND DISSEMINATION


The trial has been approved by the Regional Committees for Medical and Health Research Ethics (REC) in Norway (REC South East #29238), who granted LOADS exemption from consent requirements for all eligible, admitted patients. Data are considered highly sensitive but can be made available on request. Results will be published in peer-reviewed journals and presented at scientific conferences and meetings.
TRIAL REGISTRATION NUMBER


ISRCTN16876467.
PROTOCOL VERSION


1.4, 21 December 2021.",2022,Open-door policy (ODP) is a service model for psychiatric ward treatment that prioritises collaborative and motivational measures to better achieve acute psychiatric safety - and treatment objectives.,"['acute psychiatric inpatients', 'VERSION\n\n\n1.4, 21 December 2021', 'patients referred to acute ward care']","['Open-door policy (ODP', 'TAU or ODP']","['proportion of patient stays with one or more coercive measures', ""adverse events involving patients and/or staff, substance use and users' experiences of the treatment environment and of coercion""]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0009236', 'cui_str': 'Coercion'}]",,0.10478,Open-door policy (ODP) is a service model for psychiatric ward treatment that prioritises collaborative and motivational measures to better achieve acute psychiatric safety - and treatment objectives.,"[{'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Kunøe', 'Affiliation': 'Department of Psychiatry, Lovisenberg Diakonale Sykehus AS, Oslo, Norway nku@lds.no.'}, {'ForeName': 'Hans Martin', 'Initials': 'HM', 'LastName': 'Nussle', 'Affiliation': 'Department of Psychiatry, Lovisenberg Diakonale Sykehus AS, Oslo, Norway.'}, {'ForeName': 'Anne-Marthe', 'Initials': 'AM', 'LastName': 'Indregard', 'Affiliation': 'Department of Psychiatry, Lovisenberg Diakonale Sykehus AS, Oslo, Norway.'}]",BMJ open,['10.1136/bmjopen-2021-058501']
2130,35172988,Impact of prior oral anticoagulant use and outcomes on patients from secondary analysis in the AUGUSTUS trial.,"OBJECTIVE


Managing antithrombotic therapy in patients with atrial fibrillation (AF) and an acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI) is challenging and can be affected by prior oral anticoagulant (OAC) treatment. We examined the relationship between prior OAC use and outcomes in the AUGUSTUS trial.
METHODS


This prespecified secondary analysis is from AUGUSTUS, an open-label, 2-by-2 factorial, RCT to evaluate the safety of apixaban versus vitamin K antagonist (VKA) and aspirin versus placebo in patients with AF and ACS and/or PCI. The primary endpoint, major or clinically relevant non-major bleeding and clinical outcomes were compared in patients receiving (n=2262) or not receiving (n=2352) an OAC prior to enrolment.
RESULTS


Patients with prior OAC use had more comorbidities, higher CHA 2 DS 2 -VASC and HAS-BLED scores, and were more likely enrolled following elective PCI. There was no difference in major or clinically relevant non-major bleeding with or without prior OAC (30 days: 5.1% vs 5.9% (adjusted HR (aHR) 0.82, 95% CI 0.63 to 1.06); 180 days: 13.5% vs 13.5% (aHR 0.98, 95% CI 0.83 to 1.16)). Patients with prior OAC use had a lower risk of death or ischaemic events (30 days: 1.7% vs 2.8% (aHR 0.61, 95% CI 0.41 to 0.92); 180 days: 5.4% vs 7.6% (aHR 0.70, 95% CI 0.55 to 0.88)). No interactions between randomised treatment (apixaban vs VKA, aspirin vs placebo) and prior OAC status were observed for outcomes, apart from apixaban (vs VKA) being associated with a lower risk of myocardial infarction with prior OAC use (180 days: 2.0% vs 3.7% (aHR 0.56, 95% CI 0.33 to 0.91().
CONCLUSIONS


In AUGUSTUS, prior OAC use was associated with fewer ischaemic events but not more bleeding. In patients with AF and ACS and/or undergoing PCI, clinicians can be assured that the trial results can be applied to patients regardless of their prior OAC status.
TRIAL REGISTRATION NUMBER


NCT02415400.",2022,"Patients with prior OAC use had a lower risk of death or ischaemic events (30 days: 1.7% vs 2.8% (aHR 0.61, 95% CI 0.41 to 0.92); 180 days: 5.4% vs 7.6% (aHR 0.70, 95% CI 0.55 to 0.88)).","['patients with atrial fibrillation (AF) and an acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI', 'patients with AF and ACS and/or PCI', 'patients with AF and ACS and/or undergoing PCI']","['apixaban versus vitamin K antagonist (VKA) and aspirin versus placebo', 'apixaban vs VKA, aspirin vs placebo']","['ischaemic events', 'major or clinically relevant non-major bleeding and clinical outcomes', 'major or clinically relevant non-major bleeding', 'risk of death or ischaemic events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.247273,"Patients with prior OAC use had a lower risk of death or ischaemic events (30 days: 1.7% vs 2.8% (aHR 0.61, 95% CI 0.41 to 0.92); 180 days: 5.4% vs 7.6% (aHR 0.70, 95% CI 0.55 to 0.88)).","[{'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Welsh', 'Affiliation': 'Cardiac Sciences, University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada Robert.Welsh@albertahealthservices.ca.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Dehghani', 'Affiliation': ""Medicine, Regina Qu'Appelle Health Region, Regina, Saskatchewan, Canada.""}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Lopes', 'Affiliation': 'Cardiology, Duke Clinical Research Institute and Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Wojdyla', 'Affiliation': 'Cardiology, Duke Clinical Research Institute and Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'Bristol-Myers Squibb Co, Princeton, New Jersey, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Cardiology, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Swiss Cardiovascular Center, Bern, Switzerland.'}, {'ForeName': 'Amit N', 'Initials': 'AN', 'LastName': 'Vora', 'Affiliation': 'Cardiology, Pinnacle Heart and Vascular Institue, Harrisburg, Pennsylvania, USA.'}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Vinereanu', 'Affiliation': 'Cardiology, Carol Davila University of Medicine and Pharmacy, Bucuresti, Romania.'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Halvorsen', 'Affiliation': 'Cardiology, Oslo University Hospital and University of Oslo, Oslo, Norway.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Parkhomenko', 'Affiliation': 'Cardiology, National Scientific Center Academician M D Strazhesko Institute of Cardiology of the National Academy of Medical Sciences of Ukraine, Kiiv, Ukraine.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Cardiology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Cardiology, Duke Clinical Research Institute and Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'Canadian Heart Research Centre, Toronto, Ontario, Canada.'}]",Open heart,['10.1136/openhrt-2021-001892']
2131,35174451,Telemedical Monitoring Based on Implantable Devices-the Evolution Beyond the CardioMEMS™ Technology.,"PURPOSE OF THE REVIEW


We aimed to provide an overview of telemedical monitoring and its impact on outcomes among heart failure (HF) patients.
RECENT FINDINGS


Most HF readmissions may be prevented if clinical parameters are strictly controlled via telemedical monitoring. Predictive algorithms for patients with cardiovascular implantable electronic devices (e.g., Triage-HF Plus by Medtronic or HeartLogic by Boston Scientific) were developed to identify patients at significantly increased risk of HF events. However, randomized control trial-based data are heterogeneous regarding the advantages of telemedical monitoring in HF patients. The likelihood of adverse clinical outcomes increases when pulmonary artery pressure (PAP) rises, usually days to weeks before clinical manifestations of HF. A wireless monitoring system (CardioMEMS™) detecting changes in PAP was proposed for HF patients. CardioMEMS™ transmits data to the healthcare provider and allows to institute timely intensification of HF therapies. CardioMEMS™-guided pharmacotherapy reduced a risk of HF-related hospitalization (hazard ratio [HR]: 0.72; 95% confidence interval (CI) 0.60-0-0.85; p < 0.01). Relevant developments and innovations of telemedical care may improve clinical outcomes among HF patients. The use of CardioMEMS™ was found to be safe and cost-effective by reducing the rates of HF hospitalizations.",2022,CardioMEMS™-guided pharmacotherapy reduced a risk of HF-related hospitalization (hazard ratio [HR]: 0.72; 95% confidence interval (CI) 0.60-0-0.85; p < 0.01).,"['patients with cardiovascular implantable electronic devices (e.g., Triage-HF', 'heart failure (HF) patients', 'HF patients']",['CardioMEMS'],"['pulmonary artery pressure (PAP) rises', 'safe and cost-effective', 'risk of HF-related hospitalization', 'rates of HF hospitalizations', 'risk of HF events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",[],"[{'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.188173,CardioMEMS™-guided pharmacotherapy reduced a risk of HF-related hospitalization (hazard ratio [HR]: 0.72; 95% confidence interval (CI) 0.60-0-0.85; p < 0.01).,"[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Kotalczyk', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Jacopo F', 'Initials': 'JF', 'LastName': 'Imberti', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.'}, {'ForeName': 'David Justin', 'Initials': 'DJ', 'LastName': 'Wright', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK. jay.wright@lhch.nhs.uk.'}]",Current heart failure reports,['10.1007/s11897-021-00537-8']
2132,35174394,Trajectories of Insomnia Symptoms From Childhood Through Young Adulthood.,"
OBJECTIVES


Insomnia symptoms are transdiagnostic to physical and mental health disorders. Given the lack of population-based cohorts with objective sleep measures and long-term follow-ups, little is known about the chronicity of childhood insomnia symptoms. We determined the developmental trajectories of insomnia symptoms, their evolution into adult insomnia, and the role of objective sleep duration in the transition to adulthood.
METHODS


A total of 502 children (median 9 years old, 71.7% response rate) were studied 7.4 years later as adolescents (median 16 years old) and 15 years later as adults (median 24 years old). Insomnia symptoms were ascertained as moderate-to-severe difficulties initiating and/or maintaining sleep via parent- or self reports at all 3 time points, adult insomnia via self-report in young adulthood, and objective short-sleep duration via polysomnography in childhood and adolescence.
RESULTS


Among children with insomnia symptoms, the most frequent trajectory was persistence (43.3%), followed by remission (26.9% since childhood, 11.2% since adolescence) and a waxing-and-waning pattern (18.6%). Among children with normal sleep, the most frequent trajectory was persistence (48.1%), followed by developing insomnia symptoms (15.2% since adolescence, 20.7% in adulthood) and a waxing-and-waning pattern (16.0%). The odds of insomnia symptoms worsening into adult insomnia (22.0% of children, 20.8% of adolescents) were 2.6-fold and 5.5-fold among short-sleeping children and adolescents, respectively.
CONCLUSIONS


Early sleep interventions are a health priority because pediatricians should not expect insomnia symptoms to developmentally remit in a high proportion of children. Objective sleep measures may be clinically useful in adolescence, a critical period for the adverse prognosis of the insomnia with short-sleep duration phenotype.",2022,"The odds of insomnia symptoms worsening into adult insomnia (22.0% of children, 20.8% of adolescents) were 2.6-fold and 5.5-fold among short-sleeping children and adolescents, respectively.
","['children with normal sleep', 'children with insomnia symptoms', '502 children (median 9 years old, 71.7% response rate) were studied 7.4 years later as adolescents (median 16 years old) and 15 years later as adults (median 24 years old']",[],"['Insomnia symptoms', 'insomnia symptoms', 'insomnia symptoms worsening into adult insomnia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",502.0,0.0521095,"The odds of insomnia symptoms worsening into adult insomnia (22.0% of children, 20.8% of adolescents) were 2.6-fold and 5.5-fold among short-sleeping children and adolescents, respectively.
","[{'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Fernandez-Mendoza', 'Affiliation': 'Sleep Research & Treatment Center, Department of Psychiatry and Behavioral Health, Penn State Health Milton S. Hershey Medical Center.'}, {'ForeName': 'Kristina P', 'Initials': 'KP', 'LastName': 'Lenker', 'Affiliation': 'Sleep Research & Treatment Center, Department of Psychiatry and Behavioral Health, Penn State Health Milton S. Hershey Medical Center.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Calhoun', 'Affiliation': 'Sleep Research & Treatment Center, Department of Psychiatry and Behavioral Health, Penn State Health Milton S. Hershey Medical Center.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Qureshi', 'Affiliation': 'Sleep Research & Treatment Center, Department of Psychiatry and Behavioral Health, Penn State Health Milton S. Hershey Medical Center.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ricci', 'Affiliation': 'Sleep Research & Treatment Center, Department of Psychiatry and Behavioral Health, Penn State Health Milton S. Hershey Medical Center.'}, {'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Bourchtein', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Department of Public Health Sciences, Penn State University College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Alexandros N', 'Initials': 'AN', 'LastName': 'Vgontzas', 'Affiliation': 'Sleep Research & Treatment Center, Department of Psychiatry and Behavioral Health, Penn State Health Milton S. Hershey Medical Center.'}, {'ForeName': 'Jiangang', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Public Health Sciences, Penn State University College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Duanping', 'Initials': 'D', 'LastName': 'Liao', 'Affiliation': 'Department of Public Health Sciences, Penn State University College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Edward O', 'Initials': 'EO', 'LastName': 'Bixler', 'Affiliation': 'Sleep Research & Treatment Center, Department of Psychiatry and Behavioral Health, Penn State Health Milton S. Hershey Medical Center.'}]",Pediatrics,['10.1542/peds.2021-053616']
2133,35181293,How much and what: Using a buffet to determine self-regulation of food intake among young school-age children.,"Energy compensation indices are commonly used to examine self-regulation of food intake in children. However, previous studies failed to consider children's ability to self-regulate under complete autonomy. This study examined self-regulation of food intake among young children and the effect of calorie manipulation on food/nutrient intake using an unlimited lunch buffet paradigm. Participants were 66 children (M age  = 6.14, SD = 1.15 years; 68.2% male; 89.4% Latinx; 59.1% overweight/obese [OV/OB]). Children participated in a crossover research trial, one week apart. Participants consumed 2 different types of preloads followed by an ad-libitum lunch during each trial. A compensation index (COMPX) was calculated to identify the level of self-regulation in food intake. Food/nutrient intake was compared between both sessions. Results indicated OV/OB children showed poorer self-regulation compared to healthy weight children (t = 2.19, p = 0.032; Hedges' g = 0.55). There were significant differences in food intake/selection between OV/OB and healthy weight groups. OV/OB children consumed a higher amount of calorie, fat, and cholesterol after the high energy preload compared to healthy weight children (d's range: 0.31-0.48). Our findings support differences between the amount of self-regulation between normal and OV/OB children as well as the items they select in order to compensate.",2022,"Results indicated OV/OB children showed poorer self-regulation compared to healthy weight children (t=2.19, p = .032; Hedges' g = 0.55).","['young children', 'Young School-Age Children', 'Participants were 66 children (M age \u202f=\u202f6.14, SD\u202f=\u202f1.15 years; 68.2% male; 89.4% Latinx; 59.1% overweight/obese [OV/OB', 'children']","['calorie manipulation', 'Food Intake']","['poorer self-regulation', 'calorie, fat, and cholesterol', 'food intake/selection']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517493', 'cui_str': '1.15'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0013470', 'cui_str': 'Eating'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]",66.0,0.0324977,"Results indicated OV/OB children showed poorer self-regulation compared to healthy weight children (t=2.19, p = .032; Hedges' g = 0.55).","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Coccia', 'Affiliation': 'Florida International University, Department of Dietetics and Nutrition, Miami, FL United States. Electronic address: ccoccia@fiu.edu.'}, {'ForeName': 'Padideh', 'Initials': 'P', 'LastName': 'Lovan', 'Affiliation': 'University of Miami, Miller School of Medicine, Miami, FL United States.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Macchi', 'Affiliation': 'Florida International University, Department of Dietetics and Nutrition, Miami, FL United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Coto', 'Affiliation': 'University of Miami, Miller School of Medicine, Miami, FL United States.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Dick', 'Affiliation': 'Florida International University, Department of Psychology, Miami, FL United States.'}, {'ForeName': 'Paulo A', 'Initials': 'PA', 'LastName': 'Graziano', 'Affiliation': 'Florida International University, Department of Psychology, Miami, FL United States.'}]",Physiology & behavior,['10.1016/j.physbeh.2022.113745']
2134,35181556,Effect of post-operative goal-directed fluid therapy (GDFT) on organ function after orthotopic liver transplantation: Secondary outcome analysis of the COLT randomised control trial.,"BACKGROUND


Goal-directed fluid therapy (GDFT) has been shown to reduce the complications following a variety of major surgical procedures, possibly mediated by improved organ perfusion and function. We have shown that it is feasible to randomise patients to GDFT or standard fluid management following liver transplant in the cardiac-output optimisation following liver transplantation (COLT) trial. The current study compares end organ function in patients from the COLT trial who received GDFT in comparison to those receiving standard care (SC) following liver transplant.
METHODS


Adult patients with liver cirrhosis undergoing liver transplantation were randomised to GDFT or SC for the first 12 h following surgery as detailed in a published trial protocol. GDFT protocol was based on stroke volume (SV) optimisation using 250 ml crystalloid boluses. Total fluid administration and time to extubation were recorded. Hourly SV and cardiac output (CO) readings were recorded from the non-invasive cardiac output monitoring (NICOM) device in both groups. Pulmonary function was assessed by arterial blood gas (ABG) and ventilatory parameters. Lung injury was assessed using PaO 2 :FiO 2  ratios and calculated pulmonary compliance. The KDIGO score was used for determining acute kidney injury. Renal and liver graft function were assessed during the post-operative period and at 3 months and 1-year.
RESULTS


60 patients were randomised to GDFT (n = 30) or SC (n = 30). All patients completed the 12 h intervention period. GDFT group received a significantly higher total volume of fluid during the 12 h trial intervention period (GDFT 5317 (2335) vs. SC 3807 (1345) ml, p = 0.003); in particular crystalloids (GDFT 3968 (2073) vs. SC 2510 (1027) ml, p = 0.002). There was no evidence of significant difference between the groups in SV or CO during the assessment periods. Time to extubation, PaO2: FIO 2  ratios, pulmonary compliance, ventilatory or blood gas measurements were similar in both groups. There was a significant rise in serum creatinine from baseline (77 μmol/L) compared to first (87 μmol/L, p = 0.039) and second (107 μmol/L, p = 0.001) post-operative days. There was no difference between GDFT and SC in the highest KDIGO scores for the first 7 days post-LT. At 1-year follow-up, there was no difference in need for renal replacement therapy or graft function.
CONCLUSIONS


In this randomised trial of fluid therapy post liver transplant, GDFT was associated with an increased volume of crystalloids administered but did not alter early post-operative pulmonary or renal function when compared with standard care.",2022,There was no difference between GDFT and SC in the highest KDIGO scores for the first 7 days post-LT.,"['patients from the COLT trial who received GDFT in comparison to those receiving standard care (SC) following liver transplant', 'after orthotopic liver transplantation', 'Adult patients with liver cirrhosis undergoing liver transplantation', '60 patients']","['GDFT', 'SC', 'fluid therapy (GDFT', 'post-operative goal-directed fluid therapy (GDFT', 'GDFT protocol', 'GDFT or SC']","['organ function', 'total volume of fluid', 'Time to extubation, PaO2: FIO 2  ratios, pulmonary compliance, ventilatory or blood gas measurements', 'Renal and liver graft function', 'arterial blood gas (ABG) and ventilatory parameters', 'Hourly SV and cardiac output (CO) readings', 'Total fluid administration and time to extubation', 'Pulmonary function', 'serum creatinine']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0400447', 'cui_str': 'Orthotopic liver transplant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}]",60.0,0.074078,There was no difference between GDFT and SC in the highest KDIGO scores for the first 7 days post-LT.,"[{'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Froghi', 'Affiliation': 'UCL Division of Surgery & Interventional Sciences, HPB and Liver Transplantation, London, United Kingdom. Electronic address: farid.froghi@nhs.net.'}, {'ForeName': 'Vignesh', 'Initials': 'V', 'LastName': 'Gopalan', 'Affiliation': 'UCL Division of Surgery & Interventional Sciences, HPB and Liver Transplantation, London, United Kingdom.'}, {'ForeName': 'Zachos', 'Initials': 'Z', 'LastName': 'Anastasiou', 'Affiliation': 'UCL Joint Research Office, Biostatistics Group, London, United Kingdom.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Koti', 'Affiliation': 'UCL Division of Surgery & Interventional Sciences, HPB and Liver Transplantation, London, United Kingdom.'}, {'ForeName': 'Kurinchi', 'Initials': 'K', 'LastName': 'Gurusamy', 'Affiliation': 'UCL Division of Surgery & Interventional Sciences, HPB and Liver Transplantation, London, United Kingdom.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Eastgate', 'Affiliation': 'Royal Free Hospital, Critical Care Unit, London, United Kingdom.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McNeil', 'Affiliation': 'Royal Free Hospital, Critical Care Unit, London, United Kingdom.'}, {'ForeName': 'Helder', 'Initials': 'H', 'LastName': 'Filipe', 'Affiliation': 'Royal Free Hospital, Critical Care Unit, London, United Kingdom.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pinto', 'Affiliation': 'Royal Free Hospital, Critical Care Unit, London, United Kingdom.'}, {'ForeName': 'Jeshika', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'PHMR Limited, London, United Kingdom.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Longworth', 'Affiliation': 'PHMR Limited, London, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mallett', 'Affiliation': 'Royal Free Hospital, Critical Care Unit, London, United Kingdom.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Schofield', 'Affiliation': 'Royal Free Hospital, Critical Care Unit, London, United Kingdom.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Thorburn', 'Affiliation': 'UCL Institute for Liver and Digestive Health, London, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'UCL Division of Surgery & Interventional Sciences, London, United Kingdom; Peninsula Medical School, University of Plymouth, Plymouth, United Kingdom.'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Davidson', 'Affiliation': 'UCL Division of Surgery & Interventional Sciences, HPB and Liver Transplantation, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2022.106265']
2135,35182665,"Effects of Yi-Gan-san on the psychiatric behavior of children and adolescents with Tourette's Syndrome: A randomized, double-blind, controlled preliminary study.","ETHNOPHARMACOLOGICAL RELEVANCE


Gilles de la Tourette's Syndrome (TS) is a childhood-onset disease with clinical features of motor and phonic tics. Yi-Gan-san (YGS) is a traditional Chinese medicine formula that can reduce aggressiveness and agitation and inhibit dopamine function. This study investigated the effects of YGS on the psychiatric behavior of children and adolescents with TS.
METHODS


A double-blind, randomized, controlled preliminary study was conducted. A total of 38 patients with TS were assigned to the control group (CG, 19 patients) who received the oral administration of YGS placebo (90% starch and 10% YGS; 2.5 g thrice daily) or to a treatment group (TG, 19 patients) who received YGS for 4 weeks. The primary outcome measure was the change in Yale Global Tic Severity Scale (YGTSS) overall and subscale scores.
RESULTS


The intensity score for phonic tics before oral administration of YGS, and after 2 weeks, 3 weeks and 4 weeks was not significantly different between CG and TG groups (2.94 ± 1.14 vs 2.79 ± 1.08, p = .686; 2.29 ± 1.21 vs 1.95 ± 1.08, p = .370; 2.41 ± 1.18 vs 2.05 ± 1.51, p = .435; and 2.29 ± 1.26 vs 1.84 ± 1.42, p = .323, respectively), while the intensity score for phonic tics after 1-week oral administration of YGS in the TG was 1.89 ± 1.10 lower than 3.06 ± 1.39 in the CG (p = .008).
CONCLUSION


Oral administration of YGS for 1 week only reduced the intensity of phonic tics compared with oral administration of YGS placebo, suggesting that YGS can reduce their intensity for a short period, and the compliance of oral administration of YGS for 4 weeks can be accepted in children and adolescents with Tourette's Syndrome. However, because this study was preliminary, the selection of an appropriate placebo and dosage and long-term observations are crucial areas for future studies.",2022,"Oral administration of YGS for 1 week only reduced the intensity of phonic tics compared with oral administration of YGS placebo, suggesting that YGS can reduce their intensity for a short period, and the compliance of oral administration of YGS for 4 weeks can be accepted in children and adolescents with Tourette's Syndrome.","['children and adolescents with TS', ""children and adolescents with Tourette's Syndrome"", '38 patients with TS', 'Gilles de la']","['placebo', 'YGS placebo', 'YGS placebo (90% starch and 10% YGS', 'Yi-Gan-san (YGS', 'Yi-Gan-san', 'YGS']","['intensity score for phonic tics', 'change in Yale Global Tic Severity Scale (YGTSS) overall and subscale scores', 'psychiatric behavior', 'intensity of phonic tics']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0040517', 'cui_str': ""Gilles de la Tourette's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2001636', 'cui_str': 'Yi-Gan San'}, {'cui': 'C0038179', 'cui_str': 'Starch'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0751901', 'cui_str': 'Tic, Vocal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",38.0,0.387313,"Oral administration of YGS for 1 week only reduced the intensity of phonic tics compared with oral administration of YGS placebo, suggesting that YGS can reduce their intensity for a short period, and the compliance of oral administration of YGS for 4 weeks can be accepted in children and adolescents with Tourette's Syndrome.","[{'ForeName': 'Cheng-Hao', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung City, 40402, Taiwan; Department of Chinese Medicine, China Medical University Hospital, Taichung City, 40447, Taiwan. Electronic address: d12628@mail.cmuh.org.tw.'}, {'ForeName': 'Wen-Ling', 'Initials': 'WL', 'LastName': 'Liao', 'Affiliation': 'Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung City, 40402, Taiwan; Center for Personalized Medicine, China Medical University Hospital, Taichung City, 40447, Taiwan. Electronic address: wl0129@mail.cmu.edu.tw.'}, {'ForeName': 'Der-Yen', 'Initials': 'DY', 'LastName': 'Lee', 'Affiliation': 'Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung City, 40402, Taiwan. Electronic address: deryen.lee@gmail.com.'}, {'ForeName': 'I-Ching', 'Initials': 'IC', 'LastName': 'Chou', 'Affiliation': ""School of Chinese Medicine, China Medical University, Taichung City, 40402, Taiwan; Division of Pediatric Neurology, China Medical University Children's Hospital, Taichung City, 40447, Taiwan. Electronic address: iching@mail.cmuh.org.tw.""}, {'ForeName': 'Ming-Yu', 'Initials': 'MY', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, China Medical University Hsinchu Hospital, Hsinchu County, 302, Taiwan. Electronic address: mingyu945@gmail.com.'}, {'ForeName': 'Ching-Liang', 'Initials': 'CL', 'LastName': 'Hsieh', 'Affiliation': 'Department of Chinese Medicine, China Medical University Hospital, Taichung City, 40447, Taiwan; Chinese Medicine Research Center, China Medical University, Taichung City, 40402, Taiwan; Graduate Institute of Acupuncture Science, China Medical University, Taichung City, 40402, Taiwan. Electronic address: clhsieh@mail.cmuh.org.tw.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2022.115098']
2136,35173164,Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial.,"The excellent outcomes seen in patients treated with adjuvant trastuzumab emtansine (T-DM1) in the ATEMPT trial and the favorable toxicity profile associated with this agent make T-DM1 a potential therapeutic option for select patients with stage I HER2-positive breast cancer. Moreover, T-DM1 is an established adjuvant treatment for patients with HER2-positive breast cancer with the residual invasive disease after neoadjuvant therapy. Given that cardiotoxicity is the most significant adverse event of trastuzumab, which is a main molecular component of T-DM1, we conducted a sub-analysis of the ATEMPT trial to determine the cardiac safety of adjuvant T-DM1. In this analysis, the incidence of grade 3-4 left ventricular systolic dysfunction (LVSD) in T-DM1 or trastuzumab plus paclitaxel arms were respectively 0.8 and 1.8%. In addition, three (0.8%) patients in the T-DM1 arm and six (5.3%) patients in the adjuvant paclitaxel with trastuzumab (TH) arm experienced a significant asymptomatic left ventricular ejection fraction (LVEF) decline that per-protocol required holding T-DM1 or trastuzumab. All patients with available follow-up data experienced full resolution of cardiac symptoms and LVEF normalization. Furthermore, we performed an exploratory analysis to assess the relationship between age, baseline LVEF, and body mass index with cardiac outcomes. No significant association between these baseline characteristics and the incidence of significant asymptomatic LVEF decline or symptomatic LVSD was identified. The low incidence of significant cardiac adverse events in this population during therapy with adjuvant T-DM1 suggests that studies on the cost-effectiveness of cardiac monitoring during adjuvant therapy using anthracycline-free regimens are needed.Clinical Trial Registration: ClinicalTrials.gov, NCT01853748.",2022,The excellent outcomes seen in patients treated with adjuvant trastuzumab emtansine (T-DM1) in the ATEMPT trial and the favorable toxicity profile associated with this agent make T-DM1 a potential therapeutic option for select patients with stage I HER2-positive breast cancer.,"['patients with stage I HER2-positive breast cancer', 'patients with HER2-positive breast cancer with the residual invasive disease after neoadjuvant therapy']","['adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab', 'adjuvant paclitaxel with trastuzumab (TH', 'adjuvant trastuzumab emtansine (T-DM1']","['full resolution of cardiac symptoms and LVEF normalization', 'asymptomatic left ventricular ejection fraction (LVEF) decline', 'incidence of grade 3-4 left ventricular systolic dysfunction (LVSD', 'asymptomatic LVEF decline or symptomatic LVSD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C1277187', 'cui_str': 'Left ventricular systolic dysfunction'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",,0.349786,The excellent outcomes seen in patients treated with adjuvant trastuzumab emtansine (T-DM1) in the ATEMPT trial and the favorable toxicity profile associated with this agent make T-DM1 a potential therapeutic option for select patients with stage I HER2-positive breast cancer.,"[{'ForeName': 'Romualdo', 'Initials': 'R', 'LastName': 'Barroso-Sousa', 'Affiliation': 'Oncology Center, Hospital Sírio-Libanês Brasília, Brasília, Brazil.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Tarantino', 'Affiliation': 'European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Nabihah', 'Initials': 'N', 'LastName': 'Tayob', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Chau', 'Initials': 'C', 'LastName': 'Dang', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Yardley', 'Affiliation': 'Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Isakoff', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Valero', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Faggen', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Mulvey', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Bose', 'Affiliation': 'Washington University, St Louis, MO, USA.'}, {'ForeName': 'Jiani', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Weckstein', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Johns Hopkins Sidney Kimmel Cancer Center, Baltimore, MD, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Reeder-Hayes', 'Affiliation': 'UNC Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'UCSF, San Francisco, CA, USA.'}, {'ForeName': 'Bhuvaneswari', 'Initials': 'B', 'LastName': 'Ramaswamy', 'Affiliation': 'OSU Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zuckerman', 'Affiliation': ""St Luke's Mountain States Tumor Institute, Boise, ID, USA.""}, {'ForeName': 'Lowell', 'Initials': 'L', 'LastName': 'Hart', 'Affiliation': 'Wake Forest Baptist Health, Winston-Salem, NC, USA.'}, {'ForeName': 'Vijayakrishna K', 'Initials': 'VK', 'LastName': 'Gadi', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Constantine', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Kit', 'Initials': 'K', 'LastName': 'Cheng', 'Affiliation': 'North Shore-LIJ Cancer Institute, Lake Success, NY, USA.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Briccetti', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Schneider', 'Affiliation': 'IU School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Audrey Merrill', 'Initials': 'AM', 'LastName': 'Garrett', 'Affiliation': 'Northern Light Cancer Care, Brewer, ME, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Marcom', 'Affiliation': 'Duke University, Durham, NC, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Albain', 'Affiliation': 'Loyola University Medical Center, Maywood, IL, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'DeFusco', 'Affiliation': 'Hartford Healthcare Cancer Institute, Hartford, CT, USA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Tung', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Ardman', 'Affiliation': 'Lowell General Hospital, Lowell, MA, USA.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Jankowitz', 'Affiliation': 'Abramsom Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mothaffar', 'Initials': 'M', 'LastName': 'Rimawi', 'Affiliation': 'Dan L. Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Abramson', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Pohlmann', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Van Poznak', 'Affiliation': 'Rogel Cancer Center, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Forero-Torres', 'Affiliation': 'Kirklin UAB Hematology Oncology, Birmingham, AL, USA.'}, {'ForeName': 'Minetta', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Shoshana M', 'Initials': 'SM', 'LastName': 'Rosenberg', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Trippa', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Barry', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'DeMeo', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Burstein', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Partridge', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Krop', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA. Sara_Tolaney@DFCI.HARVARD.EDU.'}]",NPJ breast cancer,['10.1038/s41523-022-00385-2']
2137,35174670,"The effect of telerehabilitation on quality of life, anxiety, and depression in children with cystic fibrosis and caregivers: A single-blind randomized trial.","BACKGROUND


Postural and aerobic exercises are essential in rehabilitation in cystic fibrosis (CF). The aim of this study is to examine the effect of telerehabilitation on the quality of life, depression, and anxiety levels of children with CF and their caregivers' mood and anxiety levels.
MATERIALS AND METHODS


Patients between the ages of 6-13 with CF were randomized into two groups. Study group received an exercise program three times a week via Zoom for 12 weeks. Cystic Fibrosis Revised Questionnaire (CFQ-R), Anxiety and Depression Scale in Children-Revised (RCADS) were applied to the patients and State-Trait Anxiety Scale (STAI) and Beck Depression Inventory (BDI) were applied to the caregivers in the beginning and at the end of the program. Patients' FEV1 levels and 6-min walk tests were also measured.
RESULTS


Twenty-eight patient-caregiver dyads, 14 dyads in each group, completed the study. The initial mean RCADS-Major depressive disorder score of the patients in the exercise group was 6.21 ± 3.11, and this value decreased to 3.92 ± 3.79 at the end of the study and was significantly better (p < 0.02). A similar significant change was observed when the RCADS-generalized anxiety disorder score decreased from the initial mean level of 6.28 ± 2.81 to 3.42 ± 2.65 (p < 0.01). There were significant changes in improvement in the body image in telerehabilitation group. Similar significant changes were not observed in the control group. Caregivers' anxiety and depression levels did not change significantly.
CONCLUSION


A short-term telerehabilitation program improved patients' anxiety and depression levels, body image, and functional status. However, caregiver anxiety and depression levels did not change significantly.",2022,"A short-term telerehabilitation program improved patients' anxiety and depression levels, body image and functional status.","['Children With Cystic Fibrosis And Caregivers', 'Patients between the ages of 6-13 with CF', ""children with CF and their caregivers' mood and anxiety levels""]","['exercise program', 'Telerehabilitation', 'Postural and aerobic exercises']","['RCADS-generalized anxiety disorder score', ""Caregivers' anxiety and depression levels"", 'Cystic Fibrosis Revised Questionnaire (CFQ-R), Anxiety and Depression Scale', 'FEV1 levels and six-minute walk tests', 'Quality Of Life, Anxiety And Depression', 'initial mean RCADS-Major depressive disorder score', 'quality of life, depression and anxiety levels', 'caregiver anxiety and depression levels', ""patients' anxiety and depression levels, body image and functional status"", 'State-Trait Anxiety Scale (STAI) and Beck Depression Inventory (BDI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0431693', 'cui_str': 'Familial hypoplastic, glomerulocystic kidney'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",,0.0172105,"A short-term telerehabilitation program improved patients' anxiety and depression levels, body image and functional status.","[{'ForeName': 'Özge', 'Initials': 'Ö', 'LastName': 'Kenis-Coskun', 'Affiliation': 'Department of\xa0Physical Medicine and Rehabilitation, Marmara University Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Ahsen N', 'Initials': 'AN', 'LastName': 'Aksoy', 'Affiliation': 'Marmara University Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Eda N', 'Initials': 'EN', 'LastName': 'Kumaş', 'Affiliation': 'Marmara University Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Aybike', 'Initials': 'A', 'LastName': 'Yılmaz', 'Affiliation': 'Marmara University Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Elifnur', 'Initials': 'E', 'LastName': 'Güven', 'Affiliation': 'Marmara University Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Hatice H', 'Initials': 'HH', 'LastName': 'Ayaz', 'Affiliation': 'Marmara University Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Tuğçe', 'Initials': 'T', 'LastName': 'Sözer', 'Affiliation': 'Department of\xa0Physical Medicine and Rehabilitation, Marmara University Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Almala P', 'Initials': 'AP', 'LastName': 'Ergenekon', 'Affiliation': 'Department of\xa0Pediatric Pulmonology, Marmara University Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Evrim', 'Initials': 'E', 'LastName': 'Karadağ-Saygı', 'Affiliation': 'Department of\xa0Physical Medicine and Rehabilitation, Marmara University Medical Faculty, Istanbul, Turkey.'}]",Pediatric pulmonology,['10.1002/ppul.25860']
2138,35174901,Evaluation of a novel mechanical compression device for hematoma prevention and wound cosmesis after CIED implantation.,"BACKGROUND


An important complication of cardiac implantable electronic devices (CIED) implantation is the development of hematoma and device infection.
OBJECTIVE


We aimed to evaluate a novel mechanical compression device for hematoma prevention and cosmetic outcomes following CIED implantation.
METHODS


An open, prospective, randomized, single-center clinical trial was performed in patients undergoing CIED implantation. Patients were randomized to receive a novel mechanical compression device (PressRite, PR) or to receive the standard of care post device implantation. Skin pliability was measured with a calibrated durometer; the surgical site was evaluated using the Manchester Scar Scale (MSS) by a blinded plastic surgeon and the Patient and Observer Scar Scale (POSAS). Performance of PR was assessed through pressure measurements, standardized scar scales and tolerability.
RESULTS


From the total of 114 patients evaluated for enrollment, 105 patients were eligible for analysis. Fifty-one patients were randomized to management group (PR) and 54 to the control group. No patients required early removal or experienced adverse effects from PR application. There were 11 hematomas (14.8% vs. 5.9% in the control and PR group respectively, p = NS). The control group had higher post procedure durometer readings in the surgical site when compared with the PR group (7.50 ± 3.45 vs. 5.37 ± 2.78; p = < .01). There were lower MSS scores in the PR group after 2 weeks (p = .03).
CONCLUSION


We have demonstrated the safety of PR application and removal. In addition, PR appears to improve postoperative skin pliability, which could facilitate wound healing.",2022,"There were 11 hematomas (14.8% vs. 5.9% in the control and PR group respectively, p = NS).","['patients undergoing CIED implantation', '114 patients evaluated for enrollment, 105 patients were eligible for analysis']","['novel mechanical compression device', 'cardiac implantable electronic devices (CIED', 'novel mechanical compression device (PressRite, PR) or to receive the standard of care post device implantation']","['wound healing', 'Manchester Scar Scale (MSS', 'Performance PR', 'early removal or experienced adverse effects', 'Observer Scar Scale (POSAS', 'Skin pliability', 'MSS scores', 'pressure measurements, standardized scar scales and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0563291', 'cui_str': 'Mechanical compression'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",51.0,0.0345332,"There were 11 hematomas (14.8% vs. 5.9% in the control and PR group respectively, p = NS).","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rojas', 'Affiliation': 'Department of Cardiology, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Morgaenko', 'Affiliation': 'Department of Cardiology, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Department of Cardiology, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'Sieu', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'Sula', 'Initials': 'S', 'LastName': 'Mazimba', 'Affiliation': 'Department of Cardiology, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Department of Cardiology, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Darby', 'Affiliation': 'Department of Cardiology, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Monfredi', 'Affiliation': 'Department of Cardiology, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Mason', 'Affiliation': 'Department of Cardiology, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'James Michael', 'Initials': 'JM', 'LastName': 'Mangrum', 'Affiliation': 'Department of Cardiology, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Haines', 'Affiliation': 'Department of Cardiology, William Beaumont Oakland University School of Medicine, Royal Oak, Michigan, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': 'Department of Cardiology, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Bilchick', 'Affiliation': 'Department of Cardiology, University of Virginia Health System, Charlottesville, Virginia, USA.'}, {'ForeName': 'Nishaki K', 'Initials': 'NK', 'LastName': 'Mehta', 'Affiliation': 'Department of Cardiology, William Beaumont Oakland University School of Medicine, Royal Oak, Michigan, USA.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.14454']
2139,35175092,User experiences of a culturally adapted web-based intervention for posttraumatic stress disorder in Egypt: A qualitative study.,"The following study describes the usability and the acceptability of an online intervention for the treatment of posttraumatic stress disorder (PTSD), PTSD Coach Online that was culturally adapted and translated into local Egyptian dialect. The adapted intervention was piloted in a randomized control trial with 87 Egyptians meeting clinical criteria for a diagnosis of PTSD. Of the 41 participants who participated in the treatment condition, 15 participants (10 females, 5 males) were randomly selected to take part in a semistructured interview to explore their user experience. Favorable feedback centered on the program's ease of access, user-friendly tools, and cultural appropriateness. Participants also described benefits including increased awareness of PTSD, symptom reduction, and increased willingness to seek psychological support online or in person. In contrast, participants highlighted some drawbacks of the online program, particularly the need for further support or some kind of ""human"" interaction as well as feelings that the information was not sufficiently personalized and that activities could have been more interesting. The findings suggest that while the PTSD Coach Online-Arabic is unlikely to be an effective stand-alone support, approximately half of the sample indicated that the availability of online tools is important for accessibility of mental health care, particularly for those concerned with stigma. As such, it may be an important supplemental offering for other forms of ongoing care and support. Future research may consider integrated approaches to care that were highlighted as being of particular interest to participants. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,The adapted intervention was piloted in a randomized control trial with 87 Egyptians meeting clinical criteria for a diagnosis of PTSD.,"['87 Egyptians meeting clinical criteria for a diagnosis of PTSD', '41 participants who participated in the treatment condition, 15 participants (10 females, 5 males', 'posttraumatic stress disorder in Egypt']","['online intervention', 'culturally adapted web-based intervention']","['awareness of PTSD, symptom reduction, and increased willingness to seek psychological support online or in person']","[{'cui': 'C0013717', 'cui_str': 'Egyptian language'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",87.0,0.0224276,The adapted intervention was piloted in a randomized control trial with 87 Egyptians meeting clinical criteria for a diagnosis of PTSD.,"[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ellis', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Hosny', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Miller-Graff', 'Affiliation': 'Department of Psychology.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000429']
2140,35176501,Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.,"Stepped-wedge cluster randomized trial (SW-CRT) designs are increasingly employed in pragmatic research; they differ from traditional parallel cluster randomized trials in which an intervention is delivered to a subset of clusters, but not to all. In a SW-CRT, all clusters receive the intervention under investigation by the end of the study. This approach is thought to avoid ethical concerns about the denial of a desired intervention to participants in control groups. Such concerns have been cited in the literature as a primary motivation for choosing SW-CRT design, however SW-CRTs raise additional ethical concerns related to the delayed implementation of an intervention and consent. Yet, PCT investigators may choose SW-CRT designs simply because they are concerned that other study designs are infeasible. In this paper, we examine justifications for the use of SW-CRT study design, over other designs, by drawing on the experience of the National Institutes of Health's Health Care Systems Research Collaboratory (NIH Collaboratory) with five pragmatic SW-CRTs. We found that decisions to use SW-CRT design were justified by practical and epistemic reasons rather than ethical ones. These include concerns about feasibility, the heterogeneity of cluster characteristics, and the desire for simultaneous clinical evaluation and implementation. In this paper we compare the potential benefits of SW-CRTs against the ethical and epistemic challenges brought forth by the design and suggest that the choice of SW-CRT design must balance epistemic, feasibility and ethical justifications. Moreover, given their complexity, such studies need rigorous and informed ethical oversight.",2022,"In this paper, we examine justifications for the use of SW-CRT study design, over other designs, by drawing on the experience of the National Institutes of Health's Health Care Systems Research Collaboratory (NIH Collaboratory) with five pragmatic SW-CRTs.",[],['SW-CRTs'],[],[],"[{'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}]",[],,0.0945066,"In this paper, we examine justifications for the use of SW-CRT study design, over other designs, by drawing on the experience of the National Institutes of Health's Health Care Systems Research Collaboratory (NIH Collaboratory) with five pragmatic SW-CRTs.","[{'ForeName': 'Carole A', 'Initials': 'CA', 'LastName': 'Federico', 'Affiliation': 'Stanford Center for Biomedical Ethics, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA 98185, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lantos', 'Affiliation': ""Children's Mercy Hospital Bioethics Center, University of Missouri-Kansas City, Kansas City, MO 64108, USA.""}, {'ForeName': 'Pearl', 'Initials': 'P', 'LastName': ""O'Rourke"", 'Affiliation': 'Harvard Medical School, Boston, MA 02115, / USA.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Rahimzadeh', 'Affiliation': 'Stanford Center for Biomedical Ethics, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Sugarman', 'Affiliation': 'Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD 21218, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Weinfurt', 'Affiliation': 'Center for Health Measurement, Duke University, Durham, NC 27701, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wendler', 'Affiliation': 'Department of Bioethics, NIH Clinical Center, Bethesda, MD 20892, USA.'}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Wilfond', 'Affiliation': ""Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, WA 98185, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Magnus', 'Affiliation': 'Stanford Center for Biomedical Ethics, Stanford University, Stanford, CA 94305, USA. Electronic address: dmagnus@stanford.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106703']
2141,35179037,Grayscale Ultrasound Texture Features of Carotid and Brachial Arteries in People With HIV Infection Before and After Antiretroviral Therapy.,"Background We aimed to investigate novel grayscale ultrasound characteristics of the carotid and brachial arteries in people with HIV infection before and after starting initial antiretroviral therapy (ART). Methods and Results We performed grayscale ultrasound image analyses of the common carotid artery (CCA) and brachial artery before and after receipt of 1 of 3 randomly allocated ART regimens. We measured arterial wall echogenicity (grayscale median), contrast (gray-level difference statistic method), and entropy. These measures and their changes were compared with atherosclerotic cardiovascular disease risk factors, measures of HIV disease severity, and inflammatory biomarkers before and after ART. Changes in the grayscale measures were evaluated within and between ART arms. Among 201 ART-naïve people with HIV, higher systolic blood pressure, higher body mass index, lower CD4+ T cells, and non-Hispanic White race and ethnicity were associated independently with lower CCA grayscale median. Changes in each CCA grayscale measure from baseline to 144 weeks correlated with changes in soluble CD163: grayscale median (ρ=-0.17;  P =0.044), gray-level difference statistic-contrast (ρ=-0.19;  P =0.024), and entropy (ρ=-0.21;  P =0.016). Within the atazanavir/ritonavir arm, CCA entropy increased (adjusted β=0.023 [95% CI, 0.001-0.045];  P =0.04), but no other within-arm changes in grayscale measures were seen. Correlations of brachial artery grayscale measures were weaker. Conclusions In ART-naïve people with HIV, CCA grayscale ultrasound measures were associated with atherosclerotic cardiovascular disease risk factors and lower grayscale median was associated with lower CD4+ T cells. Reductions in soluble CD163 with initial ART were associated with improvements in all 3 CCA grayscale measures, suggesting that reductions in macrophage activation with ART initiation may lead to less arterial injury. Registration URL: https://clinicaltrials.gov/; Unique identifiers: NCT00811954; NCT00851799.",2022,"Within the atazanavir/ritonavir arm, CCA entropy increased (adjusted β=0.023 [95% CI, 0.001-0.045];  P =0.04), but no other within-arm changes in grayscale measures were seen.","['people with HIV infection before and after starting initial antiretroviral therapy (ART', 'People With HIV Infection']",['atazanavir/ritonavir'],"['arterial wall echogenicity (grayscale median), contrast (gray-level difference statistic method), and entropy', 'systolic blood pressure, higher body mass index, lower CD4+ T cells, and non-Hispanic White race and ethnicity', 'atherosclerotic cardiovascular disease risk factors', 'atherosclerotic cardiovascular disease risk factors, measures of HIV disease severity, and inflammatory biomarkers', 'CCA entropy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0507850', 'cui_str': 'Wall of artery'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}]",,0.293378,"Within the atazanavir/ritonavir arm, CCA entropy increased (adjusted β=0.023 [95% CI, 0.001-0.045];  P =0.04), but no other within-arm changes in grayscale measures were seen.","[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Hughey', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health Madison WI.'}, {'ForeName': 'Belinda W', 'Initials': 'BW', 'LastName': 'Vuong', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health Madison WI.'}, {'ForeName': 'Heather B', 'Initials': 'HB', 'LastName': 'Ribaudo', 'Affiliation': 'Harvard T.H. Chan School of Public Health Boston MA.'}, {'ForeName': 'Carol C K', 'Initials': 'CCK', 'LastName': 'Mitchell', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health Madison WI.'}, {'ForeName': 'Claudia E', 'Initials': 'CE', 'LastName': 'Korcarz', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health Madison WI.'}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Keck School of Medicine of University of Southern California Los Angeles CA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'David Geffen School of Medicine at University of California-Los Angeles Los Angeles CA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Stein', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health Madison WI.'}]",Journal of the American Heart Association,['10.1161/JAHA.121.024142']
2142,35179337,Assessment of Sirolimus- vs. paCLitaxEl-coated balloon angioPlasty In atherosclerotic femoropopliteal lesiOnS (ASCLEPIOS Study): preliminary results.,"BACKGROUND


There appears to be an association between paclitaxel-coated devices and increased 5-year all-cause mortality.
METHODS


We are conducting a prospective, randomized, controlled, single-center, noninferiority study. All consecutive patients with femoropopliteal arterial disease who fulfilled the inclusion/exclusion criteria are sequentially and consecutively assigned to either paclitaxel (Ranger, Boston Scientific) or sirolimus (MagicTouch, Concept Medical) coated balloon angioplasty treatment. The primary outcome are procedural success and primary vessel patency at index procedure. The secondary outcomes are 30-day and 12-month freedom from MAEs (amputation, death, TLR/TVR, MI, distal embolization that requires a separate intervention or hospitalization), procedural success (≤30% residual diameter stenosis or occlusion after the procedure), Rutherford category improvement (reduction ≤1 category) and ABI improvement (increase ≥0.10 from baseline).
RESULTS


A total of six patients have been enrolled in the present study up to now. The mean age was 72.6 years old and five were male. All patients had angiographic evidence of isolated occlusion in the transition segment of the distal femoral superficial artery in the popliteal artery. The mean length was 109 mm. Three patients were treated by sirolimus-coated (group A) and three by paclitaxel coated balloon angioplasty (group B). The primary patency and procedural success was in two of three and three of three patients, for group A and B, respectively.
CONCLUSIONS


Preliminary results show safety and feasibility of the Sirolimus-coated balloon angioplasty. Further investigation and increase of sample size will allow for more sustained conclusions regarding patency and procedural success of this type of balloons for the endovascular treatment of peripheral arterial disease.",2022,"The primary patency and procedural success was in two of three and three of three patients, for group A and B, respectively.
","['The mean age was 72.6 years old and five were male', 'All patients had angiographic evidence of isolated occlusion in the transition segment of the distal femoral superficial artery in the popliteal artery', 'All consecutive patients with femoropopliteal arterial disease who fulfilled the inclusion/exclusion criteria are sequentially and consecutively assigned to either']","['sirolimus-coated', 'Sirolimus- vs. paCLitaxEl-coated balloon angioPlasty', 'paclitaxel coated balloon angioplasty', 'paclitaxel (Ranger, Boston Scientific) or sirolimus (MagicTouch, Concept Medical) coated balloon angioplasty treatment', 'Sirolimus-coated balloon angioplasty']","['procedural success and primary vessel patency at index procedure', '30-day and 12-month freedom from MAEs (amputation, death, TLR/TVR, MI, distal embolization that requires a separate intervention or hospitalization), procedural success (≤30% residual diameter stenosis or occlusion after the procedure), Rutherford category improvement (reduction ≤1 category) and ABI improvement', 'mean length', 'procedural success']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0852949', 'cui_str': 'Disorder of artery'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",3.0,0.0411045,"The primary patency and procedural success was in two of three and three of three patients, for group A and B, respectively.
","[{'ForeName': 'Gergana T', 'Initials': 'GT', 'LastName': 'Taneva', 'Affiliation': 'Department of Vascular Surgery, Research Vascular Center, Asklepios Clinic Langen, University of Frankfurt, Langen, Germany - dr.gtaneva@gmail.com.'}, {'ForeName': 'Georgios A', 'Initials': 'GA', 'LastName': 'Pitoulias', 'Affiliation': 'Second Department of Surgery, Division of Vascular Surgery, School of Medicine Aristotle University of Thessaloniki, &quot;G. Gennimatas&quot; Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Abu Bakr', 'Affiliation': 'Department of Vascular Surgery, Research Vascular Center, Asklepios Clinic Langen, University of Frankfurt, Langen, Germany.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Kazemtash', 'Affiliation': 'Department of Vascular Surgery, Research Vascular Center, Asklepios Clinic Langen, University of Frankfurt, Langen, Germany.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Muñoz Castellanos', 'Affiliation': 'Department of Vascular Surgery, Research Vascular Center, Asklepios Clinic Langen, University of Frankfurt, Langen, Germany.'}, {'ForeName': 'Konstantinos P', 'Initials': 'KP', 'LastName': 'Donas', 'Affiliation': 'Department of Vascular Surgery, Research Vascular Center, Asklepios Clinic Langen, University of Frankfurt, Langen, Germany.'}]",The Journal of cardiovascular surgery,['10.23736/S0021-9509.21.12169-X']
2143,35179251,"Fostamatinib for the treatment of warm antibody autoimmune hemolytic anemia: Phase 2, multicenter, open-label study.","Patients with relapsed warm antibody autoimmune hemolytic anemia (wAIHA) have limited treatment options. Fostamatinib is a potent, orally administered spleen tyrosine kinase inhibitor approved in the United States and Europe for the treatment of adults with chronic immune thrombocytopenia (ITP). This phase 2 study evaluated the response to fostamatinib, administered at 150 mg BID orally with or without food in adults with wAIHA and active hemolysis with hemoglobin (Hgb) <10 g/dL who had failed at least one prior treatment. Hemoglobin levels and safety assessments were performed at visits every 2 weeks. The primary endpoint was Hgb >10 g/dL with an increase of ≥2 g/dL from baseline by week 24 without rescue therapy or red blood cell transfusion. Eleven of 24 (46%) patients achieved the primary endpoint. Increases in median Hgb were detected at week 2 and sustained over time. Median lactate dehydrogenase levels and reticulocyte counts generally declined over time with little change in median haptoglobin levels. The most common adverse events (AEs) were diarrhea (42%), fatigue (42%), hypertension (27%), dizziness (27%), and insomnia (23%). AEs were manageable and consistent with the fostamatinib safety database of over 3900 patients across multiple diseases (rheumatoid arthritis, B-cell lymphoma, COVID-19, and ITP). No new safety signals were detected. Fostamatinib may be a promising therapeutic option for wAIHA. A randomized, double-blind, phase 3 study is nearing completion.",2022,The primary endpoint was Hgb,"['warm antibody autoimmune hemolytic anemia', 'Patients with relapsed warm antibody autoimmune hemolytic anemia (wAIHA', 'adults with wAIHA and active hemolysis with hemoglobin (Hgb', 'adults with chronic immune thrombocytopenia (ITP']",[],"['hypertension', 'diarrhea', 'dizziness', 'Median lactate dehydrogenase (LDH) levels and reticulocyte counts', 'Hemoglobin levels and safety assessments', 'fatigue', 'median Hgb', 'median haptoglobin levels']","[{'cui': 'C0301842', 'cui_str': 'Warm antibody'}, {'cui': 'C0002880', 'cui_str': 'Autoimmune hemolytic anemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}]",[],"[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0206161', 'cui_str': 'Reticulocyte count'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018595', 'cui_str': 'Haptoglobin'}]",,0.148808,The primary endpoint was Hgb,"[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kuter', 'Affiliation': 'Division of Hematology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Rogers', 'Affiliation': 'Division of Hematology, Department of Medicine, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Boxer', 'Affiliation': 'Division of Hematology-Oncology, Arizona Oncology, Tucson, Arizona, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Choi', 'Affiliation': 'Moores Cancer Center, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Richy', 'Initials': 'R', 'LastName': 'Agajanian', 'Affiliation': 'Division of Hematology-Oncology, The Oncology Institute of Hope and Innovation, Downey, California, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Arnold', 'Affiliation': 'Department of Medicine, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Broome', 'Affiliation': 'Lombardi Cancer Center, Division of Hematology, MedStar Georgetown University Hospital, Washington, District of Columbia, USA.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Field', 'Affiliation': 'Blood Center of Wisconsin, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Murakhovskaya', 'Affiliation': 'Department of Medicine (Hematology), Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Numerof', 'Affiliation': 'Development and Medical Affairs, Rigel Pharmaceuticals, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Tong', 'Affiliation': 'Development and Medical Affairs, Rigel Pharmaceuticals, Inc, South San Francisco, California, USA.'}]",American journal of hematology,['10.1002/ajh.26508']
2144,35179588,"Effect of Placement of a Supraglottic Airway Device vs Endotracheal Intubation on Return of Spontaneous Circulation in Adults With Out-of-Hospital Cardiac Arrest in Taipei, Taiwan: A Cluster Randomized Clinical Trial.","Importance


Prehospital advanced airway management with either initial endotracheal intubation (ETI) or initial supraglottic airway (SGA) insertion in patients with out-of-hospital cardiac arrest (OHCA) remains controversial.
Objective


To compare the effectiveness of ETI and SGA in patients with nontraumatic OHCA.
Design, Setting, and Participants


The Supraglottic Airway Device vs Endotracheal intubation (SAVE) trial was a multicenter cluster randomized clinical trial conducted in Taipei City, Taiwan. Individuals aged 20 years or older who experienced nontraumatic OHCA requiring advanced airway management and were treated by participating emergency medical service agencies were enrolled from November 11, 2016, to December 31, 2019. The final day of follow-up was February 19, 2020.
Interventions


Four advanced life support ambulance teams were divided into 2 randomization clusters, with each cluster assigned to either ETI or SGA in a biweekly period.
Main Outcomes and Measures


The primary outcome of the SAVE trial was sustained return of spontaneous circulation (ROSC) (≥2 hours) after resuscitation. Secondary outcomes included prehospital ROSC, survival to hospital discharge, and favorable neurologic outcome, defined as a cerebral performance category score less than or equal to 2. Prespecified subgroups and the association between time to advanced airways were explored. Per protocol and intention-to-treat analysis were performed.
Results


A total of 936 patients (517 in the ETI group and 419 in the SGA group) were included in the primary analysis (median age, 77 [IQR, 62-85] years; 569 men [60.8%]). The first-attempt airway success rates were 77% with ETI (n = 413) and 83% with SGA (n = 360). Sustained ROSC was 26.9% (n = 139) in the ETI group vs 25.8% (n = 108) in the SGA group. The odds ratio of sustained ROSC was 1.02 (95% CI, 0.98-1.06) in the ETI group vs SGA group. The odds ratio of ETA vs SGA was 1.04 (95% CI, 1.02-1.07) for prehospital ROSC, 1.00 (95% CI, 0.94-1.06) for survival to hospital discharge, and 0.99 (95% CI, 0.94-1.03) for cerebral performance category scores less than or equal to 2.
Conclusions and Relevance


In this randomized clinical trial, among patients with OHCA, initial airway management with ETI did not result in a favorable outcome of sustained ROSC compared with SGA device insertion.
Trial Registration


ClinicalTrials.gov Identifier: NCT02967952.",2022,The first-attempt airway success rates were 77% with ETI (n = 413) and 83% with SGA (n = 360).,"['Adults With Out-of-Hospital Cardiac Arrest in Taipei, Taiwan', '936 patients (517 in the ETI group and 419 in the SGA group) were included in the primary analysis (median age, 77 [IQR, 62-85] years; 569 men [60.8', 'Individuals aged 20 years or older who experienced nontraumatic OHCA requiring advanced airway management and were treated by participating emergency medical service agencies were enrolled from November 11, 2016, to December 31, 2019', 'Interventions\n\n\nFour advanced life support ambulance teams', 'patients with OHCA', 'patients with out-of-hospital cardiac arrest (OHCA', 'Taipei City, Taiwan', 'patients with nontraumatic OHCA']","['initial endotracheal intubation (ETI) or initial supraglottic airway (SGA) insertion', 'ETI and SGA', 'Supraglottic Airway Device vs Endotracheal intubation (SAVE', 'Supraglottic Airway Device vs Endotracheal Intubation', 'ETI or SGA']","['odds ratio of ETA vs SGA', 'survival to hospital discharge', 'cerebral performance category scores', 'Return of Spontaneous Circulation', 'Sustained ROSC', 'odds ratio of sustained ROSC', 'prehospital ROSC, survival to hospital discharge, and favorable neurologic outcome, defined as a cerebral performance category score less', 'sustained return of spontaneous circulation (ROSC']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0419055', 'cui_str': 'Advanced life support'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C1720127', 'cui_str': 'Eta'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]",936.0,0.396717,The first-attempt airway success rates were 77% with ETI (n = 413) and 83% with SGA (n = 360).,"[{'ForeName': 'An-Fu', 'Initials': 'AF', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Yu-Chun', 'Initials': 'YC', 'LastName': 'Chien', 'Affiliation': 'Emergency Medical Services Division, National Fire Agency, Ministry of the Interior, Taiwan.'}, {'ForeName': 'Bin-Chou', 'Initials': 'BC', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Taipei City Hospital, Zhongxiao Branch, Taipei City, Taiwan.'}, {'ForeName': 'Wen-Shuo', 'Initials': 'WS', 'LastName': 'Yang', 'Affiliation': 'Emergency Medical Services Division, Taipei City Fire Department, Taipei City, Taiwan.'}, {'ForeName': 'Yao-Cheng', 'Initials': 'YC', 'LastName': 'Wang', 'Affiliation': 'Emergency Medical Services Division, Taipei City Fire Department, Taipei City, Taiwan.'}, {'ForeName': 'Hao-Yang', 'Initials': 'HY', 'LastName': 'Lin', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Edward Pei-Chuan', 'Initials': 'EP', 'LastName': 'Huang', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu City, Taiwan.'}, {'ForeName': 'Kah-Meng', 'Initials': 'KM', 'LastName': 'Chong', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Jen-Tang', 'Initials': 'JT', 'LastName': 'Sun', 'Affiliation': 'Department of Emergency Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Huei-Ming', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Ming-Ju', 'Initials': 'MJ', 'LastName': 'Hsieh', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Wen-Chu', 'Initials': 'WC', 'LastName': 'Chiang', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.48871']
2145,35179585,Association of Prognostic Understanding With Health Care Use Among Older Adults With Advanced Cancer: A Secondary Analysis of a Cluster Randomized Clinical Trial.,"Importance


A poor prognostic understanding regarding curability is associated with lower odds of hospice use among patients with cancer. However, the association between poor prognostic understanding or prognostic discordance and health care use among older adults with advanced incurable cancers is not well characterized.
Objective


To evaluate the association of poor prognostic understanding and patient-oncologist prognostic discordance with hospitalization and hospice use among older adults with advanced cancers.
Design, Setting, and Participants


This was a post hoc secondary analysis of a cluster randomized clinical trial that recruited patients from October 29, 2014, to April 28, 2017. Data were collected from community oncology practices affiliated with the University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program. The parent trial enrolled 541 patients who were aged 70 years or older and were receiving or considering any line of cancer treatment for incurable solid tumors or lymphomas; the patients' oncologists and caregivers (if available) were also enrolled. Patients were followed up for at least 1 year. Data were analyzed from January 3 to 16, 2021.
Main Outcomes and Measures


At enrollment, patients and oncologists were asked about their beliefs regarding cancer curability (100%, >50%, 50%, <50%, and 0%; answers other than 0% reflected poor prognostic understanding) and life expectancy (≤6 months, 7-12 months, 1-2 years, 2-5 years, and >5 years; answers of >5 years reflected poor prognostic understanding). Any difference between oncologist and patient in response options was considered discordant. Outcomes were any hospitalization and hospice use at 6 months captured by the clinical research associates.
Results


Among the 541 patients, the mean (SD) age was 76.6 (5.2) years, 264 of 540 (49%) were female, and 486 of 540 (90%) were White. Poor prognostic understanding regarding curability was reported for 59% (206 of 348) of patients, and poor prognostic understanding regarding life expectancy estimates was reported for 41% (205 of 496) of patients. Approximately 60% (202 of 336) of patient-oncologist dyads were discordant regarding curability, and 72% (356 of 492) of patient-oncologist dyads were discordant regarding life expectancy estimates. Poor prognostic understanding regarding life expectancy estimates was associated with lower odds of hospice use (adjusted odds ratio, 0.30; 95% CI, 0.16-0.59). Discordance regarding life expectancy estimates was associated with greater odds of hospitalization (adjusted odds ratio, 1.64; 95% CI, 1.01-2.66).
Conclusions and Relevance


This study highlights different constructs of prognostic understanding and the need to better understand the association between prognostic understanding and health care use among older adult patients with advanced cancer.
Trial Registration


ClinicalTrials.gov Identifier: NCT02107443.",2022,"Discordance regarding life expectancy estimates was associated with greater odds of hospitalization (adjusted odds ratio, 1.64; 95% CI, 1.01-2.66).
","['patients with cancer', 'older adults with advanced cancers', 'older adults with advanced incurable cancers', ""541 patients who were aged 70 years or older and were receiving or considering any line of cancer treatment for incurable solid tumors or lymphomas; the patients' oncologists and caregivers (if available) were also enrolled"", 'community oncology practices affiliated with the University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program', '541 patients, the mean (SD) age was 76.6 (5.2) years, 264 of 540 (49%) were female, and 486 of 540 (90%) were White', 'older adult patients with advanced cancer', 'recruited patients from October 29, 2014, to April 28, 2017', 'Older Adults With Advanced Cancer']",[],"['cancer curability', 'hospitalization and hospice use', 'poor prognostic understanding) and life expectancy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C5192767', 'cui_str': '540'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]",[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",541.0,0.243125,"Discordance regarding life expectancy estimates was associated with greater odds of hospitalization (adjusted odds ratio, 1.64; 95% CI, 1.01-2.66).
","[{'ForeName': 'Kah Poh', 'Initials': 'KP', 'LastName': 'Loh', 'Affiliation': 'James P Wilmot Cancer Institute, Division of Hematology/Oncology, Department of Medicine, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Seplaki', 'Affiliation': 'Department of Public Health Sciences, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Chandrika', 'Initials': 'C', 'LastName': 'Sanapala', 'Affiliation': 'James P Wilmot Cancer Institute, Division of Hematology/Oncology, Department of Medicine, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Yousefi-Nooraie', 'Affiliation': 'Department of Public Health Sciences, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Lund', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'Center for Communication and Disparities Research, Department of Family Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, Piscataway, New Jersey.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Flannery', 'Affiliation': 'School of Nursing, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'Department of Surgery, Cancer Control, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Preventive Medicine and Population Health, School of Medicine, Sealy Center on Aging, University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McHugh', 'Affiliation': 'James P Wilmot Cancer Institute, Division of Hematology/Oncology, Department of Medicine, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Heidi D', 'Initials': 'HD', 'LastName': 'Klepin', 'Affiliation': 'Section on Hematology and Oncology, Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Po-Ju', 'Initials': 'PJ', 'LastName': 'Lin', 'Affiliation': 'Department of Surgery, Cancer Control, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Watson', 'Affiliation': 'Princeton University, Princeton, New Jersey.'}, {'ForeName': 'Valerie Aarne', 'Initials': 'VA', 'LastName': 'Grossman', 'Affiliation': 'SCOREboard Advisory Group, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Jane Jijun', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'Heartland National Cancer Institute Community Oncology Research Program (NCORP), Decatur, Illinois.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Geer', 'Affiliation': 'Metro Minnesota Community Oncology Research Program, St Louis Park.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': ""O'Rourke"", 'Affiliation': 'NCORP of the Carolinas (Greenville Health System NCORP), Greenville, South Carolina.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Mustian', 'Affiliation': 'Department of Surgery, Cancer Control, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Supriya G', 'Initials': 'SG', 'LastName': 'Mohile', 'Affiliation': 'James P. Wilmot Cancer Center, Department of Medicine, University of Rochester, Rochester, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.0018']
2146,35179587,Effectiveness of Cognitive Behavioral Therapy-Based Intervention in Preventing Gaming Disorder and Unspecified Internet Use Disorder in Adolescents: A Cluster Randomized Clinical Trial.,"Importance


Behavioral addictions were introduced as novel mental disorders in the International Classification of Diseases, 11th Revision, based on evidence that human behavior itself can become addictive, similar to addiction to substances. However, previous studies on prevention of gaming disorder and unspecified internet use disorder lacked randomization, follow-up measurements, and diagnostic interviews that assessed incidence rates; this trial was intended to fill this gap.
Objectives


To investigate whether the PROTECT (Professioneller Umgang mit technischen Medien [Professional Use of Technical Media]) intervention can reduce the symptom severity and prevent full syndrome and subthreshold onset of gaming disorder and unspecified internet use disorder in at-risk adolescents.
Design, Setting, and Participants


A multicenter cluster randomized clinical trial conducted recruitment, screening, intervention delivery, and data collection among at-risk adolescents aged 12 to 18 years in 33 high schools in Germany. Inclusion criteria for the study and symptom severity analyses were elevated symptoms of gaming disorder and unspecified internet use disorder. A subsample that met the inclusion criteria for incidence analyses (no full syndrome of gaming disorder or unspecified internet use disorder, depression, or anxiety at baseline) was analyzed for illness onset. Participants were randomized to either the PROTECT intervention group or the assessment-only control group. Participants were assessed at baseline, 1-month follow-up, 4-month follow-up, and 12-month follow-up between October 1, 2015, and September 30, 2018. Based on intent-to-treat principle, data analyses were conducted from February 8, 2019, to May 7, 2021.
Interventions


PROTECT, a theory-driven, manualized, cognitive behavioral therapy-based indicated preventive group intervention that is delivered in 4 sessions by trained psychologists. It targets changes in addictive reward processing and pathological cognitive mechanisms.
Main Outcomes and Measures


The primary outcome was symptom severity (measured by CSAS [Computerspielabhängigkeitsskala], a modified German video game dependency scale with a score range of 0-56 [higher scores indicating greater pathology]) along with incidence rates (assessed by a structured clinical interview) after 12 months. Secondary outcomes were comorbid psychopathology and problem behaviors.
Results


A total of 422 at-risk adolescents (mean [SD] age, 15.11 [2.01] years; 229 female participants [54.3%]) were randomized to either the PROTECT intervention group (n = 167; mean [SD] risk score, 29.05 [6.98]) or the assessment-only control group (n = 255; mean [SD] risk score, 26.21 [5.01]) and were included in the symptom severity analyses. Compared with the control group, the PROTECT group showed a significantly greater reduction in symptom severity of gaming disorder or unspecified internet use disorder (γ11 = -0.128; 95% CI, -0.246 to -0.011; P = .03), reflecting a 39.8% vs 27.7% reduction of symptoms with an effect size of Cohen d = 0.67 (baseline vs 12-month follow-up) for the PROTECT group. Differences in incidence rates did not reach statistical significance. The PROTECT group showed a significantly greater decrease in procrastination (γ11 = -0.458; 95% CI, -0.735 to -0.180; P < .001) over 12 months, but no significant differences were found for other secondary outcomes.
Conclusions and Relevance


Results of this trial showed that the PROTECT intervention effectively reduced symptoms of gaming disorder and unspecified internet use disorder over 12 months. The intervention did not change incidence rates of gaming disorder or unspecified internet use disorder.
Trial Registration


ClinicalTrials.gov Identifier: NCT02907658.",2022,"Conclusions and Relevance


Results of this trial showed that the PROTECT intervention effectively reduced symptoms of gaming disorder and unspecified internet use disorder over 12 months.","['2.01] years; 229 female participants [54.3', 'risk adolescents aged 12 to 18 years in 33 high schools in Germany', 'Adolescents', 'A total of 422 at-risk adolescents (mean [SD] age, 15.11']","['theory-driven, manualized, cognitive behavioral therapy-based indicated preventive group intervention', 'Cognitive Behavioral Therapy-Based Intervention', 'Technical Media]) intervention', 'assessment-only control group']","['symptom severity of gaming disorder or unspecified internet use disorder', 'symptom severity (measured by CSAS [Computerspielabhängigkeitsskala], a modified German video game dependency scale with a score range of 0-56 [higher scores indicating greater pathology', 'comorbid psychopathology and problem behaviors']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",,0.157167,"Conclusions and Relevance


Results of this trial showed that the PROTECT intervention effectively reduced symptoms of gaming disorder and unspecified internet use disorder over 12 months.","[{'ForeName': 'Katajun', 'Initials': 'K', 'LastName': 'Lindenberg', 'Affiliation': 'Institute for Psychology, Goethe-University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Kindt', 'Affiliation': 'Institute for Psychology, Goethe-University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Szász-Janocha', 'Affiliation': 'Institute for Psychology, Goethe-University Frankfurt, Frankfurt, Germany.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.48995']
2147,35179449,Changes in the skin characteristics associated with dehydration and rehydration.,"The present study aimed to test the hypothesis that changes in the dermal tissue dielectric constant (TDC) and biomechanical properties of the skin would be correlated with the indicators related to dehydration. Ten healthy adult men were enrolled in three trials: no fluid intake (DEH),  ad libitum  fluid intake (AL-HYD), and programmed fluid intake (P-HYD) after exercise in a randomised crossover design. The participants performed a pedalling exercise at 60% heart rate reserve until 2% body mass loss. At 120 min after exercise, an incremental exercise test was carried out. Aerobic capacity, body composition, TDC, biomechanical properties of the skin (pliability, viscoelasticity, and total recovery), and indicators related to dehydration in the serum and urine were measured before and 120 min after exercise. Higher values of the pliability and viscoelasticity, and lower value of the total recovery on the hand were demonstrated in the P-HYD trial compared to the DEH trial (all  P <  0.05). Changes in the TDC were significantly correlated with changes in body mass, total body water, serum osmolarity, and hematocrit (all  P  < 0.05). Changes in the biomechanical properties of the hand were significantly correlated with changes in body mass, hematocrit, and urine specific gravity (all  P <  0.05). The present study showed that the changes in skin characteristics correlated with the body water and dehydration-associated indicators in the serum and urine, thus suggesting that skin characteristics may be useful in the assessment of dehydration. Highlights  This study was the first to investigate the effect of dehydration and rehydration on the TDC and biomechanical properties of the skin upon instrumental measure, and not manual testing.This study confirmed the decline in aerobic capacity by dehydration and immediate recovery with sufficient rehydration.Changes in the TDC and the biomechanical properties of the skin correlated with the body water and dehydration-associated indicators in the serum and urine.Skin characteristics may be useful in the assessment of dehydration.",2022,"Changes in the TDC were significantly correlated with changes in body mass ( P <  0.05), total body water ( P <  0.05), serum osmolarity ( P <  0.05), and hematocrit ( P <  0.01).",['Ten healthy adult men were enrolled in three trials'],"['pedaling exercise', 'no fluid intake (DEH),  ad libitum  fluid intake (AL-HYD), and programmed fluid intake (P-HYD) after exercise']","['serum osmolarity', 'hematocrit', 'body mass, hematocrit, and urine specific gravity', 'body mass', 'Aerobic capacity, body composition, TDC, biomechanical properties of the skin (pliability, viscoelasticity, and total recovery), and indicators related to dehydration in the serum and urine', 'total body water', 'pliability and viscoelasticity, and lower value of the total recovery']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0426599', 'cui_str': 'Not taking fluids'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0202517', 'cui_str': 'Urinalysis, specific gravity measurement'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",10.0,0.0354588,"Changes in the TDC were significantly correlated with changes in body mass ( P <  0.05), total body water ( P <  0.05), serum osmolarity ( P <  0.05), and hematocrit ( P <  0.01).","[{'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Eda', 'Affiliation': 'Department of Fundamental Education, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Nakamura', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Saitama, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Inai', 'Affiliation': 'Graduate School of Sport Sciences, Waseda University, Saitama, Japan.'}, {'ForeName': 'Ziyue', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Graduate School of Sport Sciences, Waseda University, Saitama, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Sone', 'Affiliation': 'Japan Institute of Sports Sciences, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Akama', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Saitama, Japan.'}]",European journal of sport science,['10.1080/17461391.2022.2044914']
2148,35179433,'Physician advocates': a novel strategy for improving the value of hospital care by employing hospitalists part time to support non-hospitalist physicians.,"BACKGROUND AND OBJECTIVE


At many hospitals, private-practice physicians still admit their own patients and are accustomed to autonomy in clinical practice. This creates challenges for hospital's efforts to improve the efficiency, quality, and value of care. Experienced inpatient-focused physicians - 'Physician Advocates' - could act as liaisons between private practitioners and the fast-paced inpatient microsystem.
METHODS


We conducted a controlled pre-post ('differences-in-differences') analysis at an academic medical center where private-practice physicians care for about 40% of medical inpatients and hospitalist groups care for 60%. In the intervention, 'Physician Advocates' participated in daily multidisciplinary 'Progression of Care Rounds,' offering suggestions to increase care quality for private-practice physicians' patients. Controls were cared for by a large, well-established hospitalist group, which convened separate, unchanged multidisciplinary rounds. Outcomes were length of stay (LOS; primary outcome), 30-day readmissions, and inpatient mortality.
RESULTS


In a risk-adjusted analysis of 31,632 medical inpatients, LOS declined by 4 hours more from the baseline period to the post-intervention period in the intervention group relative to the control group (ratio: 0.96, 95% CI: 0.93-0.99, p = 0.004). Readmissions declined 22% more in the intervention group (OR: 0.78, 95% CI: 0.63-0.97, p = 0.023). Mortality was unchanged (OR: 1.23, 95% CI: 0.78-1.93 p-value = 0.378).
CONCLUSION


Among inpatients cared for by private practitioners, adding Physician Advocates to multidisciplinary rounds was associated with improved LOS and reduced readmissions - measures of efficiency and value. The Physician Advocates approach should be tested in diverse health systems because it allows hospitals to leverage the expertise of on-site clinicians while respecting the traditional private-practice care model, in which primary care physicians manage their hospitalized patients.",2022,"Mortality was unchanged (OR: 1.23, 95% CI: 0.78-1.93 p-value=0.378).
","['academic medical center where private-practice physicians care for about 40% of medical inpatients and hospitalist groups care for 60', ""private-practice physicians' patients"", 'inpatients cared for by private practitioners']",[],"['LOS', 'Mortality', 'length of stay (LOS; primary outcome), 30-day readmissions, and inpatient mortality', 'Readmissions']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0600620', 'cui_str': 'Hospitalist'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}]",[],"[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}]",31632.0,0.0499625,"Mortality was unchanged (OR: 1.23, 95% CI: 0.78-1.93 p-value=0.378).
","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Van Groningen', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Zab', 'Initials': 'Z', 'LastName': 'Mosenifar', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Harry C', 'Initials': 'HC', 'LastName': 'Sax', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fridman', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Sungjin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Teryl K', 'Initials': 'TK', 'LastName': 'Nuckols', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}]",Hospital practice (1995),['10.1080/21548331.2022.2044702']
2149,35183695,"Accuracy of dental implant placement using augmented reality-based navigation, static computer assisted implant surgery, and the free-hand method: An in vitro study.","OBJECTIVES


This in vitro study aimed to compare the accuracy of implant placement in model surgeries carried out by implementation of three different methods.
METHODS


An in vitro study was conducted on 3D printed study models randomly assigned to three study groups. In Group 1, model surgeries were assisted by augmented reality (AR)based dynamic navigation (Innooral System, Innoimplant Ltd, Budapest, Hungary). In Group 2, implants were placed with a free-hand method, and in Group 3, static Computer Assisted Implant Surgery (CAIS) was used (coDiagnostiX software, version 10.4 Dental Wings, Montreal, CA, USA). A total of 48 dental implants (Callus Pro, Callus Implant Solutions GmbH, Hamburg, Germany) were placed (16 implants in four models per study group). The primary outcome variables were angular deviation, coronal, and apical global deviation. These were calculated for all implants based on preoperative registration of the surgical plan and postoperative cone beam computed tomography (CBCT) reconstruction.
RESULTS


The accuracy of implant placement using AR-based dynamic navigation showed no significant difference compared to static CAIS (angular deviation, 4.09 ± 2.79° and 3.21 ± 1.52°; coronal deviation, 1.27 ± 0.40 mm and 1.31 ± 0.42 mm; and apical global deviation 1.34 ± 0.41 mm and 1.38 ± 0.41 mm). Global deviation results were significantly lower with AR-based dynamic navigation than with the free-hand approach (coronal and apical global deviation of 1.93 ± 0.79 mm and 2.28 ± 0.74 mm, respectively).
CONCLUSIONS


Implant positioning accuracy of AR-based dynamic navigation was comparable to that of static CAIS and superior to that obtained by the free-hand approach.
CLINICAL SIGNIFICANCE


Implementing Augmented Reality based dynamic Computer Assisted Implant Surgery (CAIS) in model surgeries may allow to obtain an implant positioning accuracy comparable to that provided by static CAIS, and superior to that obtained through the free-hand approach. Further clinical studies are necessary to determine the feasibility of AR-based dynamic navigation.",2022,"The accuracy of implant placement using AR-based CAIS showed no significant difference compared to static CAIS (angular deviation, 4.09 ± 2.79° and 3.21 ± 1.52°; coronal global deviation, 1.27 ± 0.40 mm and 1.31 ± 0.42 mm; and apical global deviation 1.34 ± 0.41 mm and 1.38 ± 0.41 mm).","['48 dental implants (Callus Pro, Callus Implant Solutions GmbH, Hamburg, Germany']","['dental implant placement using augmented reality-based navigation, static computer assisted implant surgery', 'based dynamic Computer Assisted Implant Surgery (CAIS']","['angular deviation, coronal, and apical global deviation', 'Global deviation results']","[{'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0006767', 'cui_str': 'Callus of bone'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",48.0,0.0586208,"The accuracy of implant placement using AR-based CAIS showed no significant difference compared to static CAIS (angular deviation, 4.09 ± 2.79° and 3.21 ± 1.52°; coronal global deviation, 1.27 ± 0.40 mm and 1.31 ± 0.42 mm; and apical global deviation 1.34 ± 0.41 mm and 1.38 ± 0.41 mm).","[{'ForeName': 'Márton', 'Initials': 'M', 'LastName': 'Kivovics', 'Affiliation': 'Department of Community Dentistry, Semmelweis University, Szentkirályi utca 40. 1088 Budapest, Hungary. Electronic address: kivovics.marton@dent.semmelweis-univ.hu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Takács', 'Affiliation': 'Dental Student, Faculty of Dentistry, Semmelweis University, Üllői út 26. 1085 Budapest, Hungary. Electronic address: takacs.anna98@stud.semmelweis.hu.'}, {'ForeName': 'Dorottya', 'Initials': 'D', 'LastName': 'Pénzes', 'Affiliation': 'Department of Community Dentistry, Semmelweis University, Szentkirályi utca 40. 1088 Budapest, Hungary. Electronic address: penzes.dorottya@dent.semmelweis-univ.hu.'}, {'ForeName': 'Orsolya', 'Initials': 'O', 'LastName': 'Németh', 'Affiliation': 'Department of Community Dentistry, Semmelweis University, Szentkirályi utca 40. 1088 Budapest, Hungary. Electronic address: nemeth.orsolya@dent.semmelweis-univ.hu.'}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Mijiritsky', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery and Maxillofacial Surgery, Tel-Aviv Sourasky Medical Center, Sackler School of Medicine, Tel-Aviv University, Tel Aviv 64239, Israel; Goldschleger School of Dental Medicine, Sackler School of Medicine, Tel-Aviv University, Tel Aviv 39040, Israel. Electronic address: mijiritsky@bezeqint.net.'}]",Journal of dentistry,['10.1016/j.jdent.2022.104070']
2150,35183671,"Sensitive inflammatory biomarkers of acute fine particulate matter exposure among healthy young adults: Findings from a randomized, double-blind crossover trial on air filtration.","The short-term alteration of peripheral cytokines may be an early adverse health effect of PM 2.5  exposure and may be further associated with cardiovascular disease. We conducted a randomized, double-blind crossover trial using true or sham air filtration among 54 healthy college students in Beijing to investigate the potential benefits of short-term indoor air filtration and the adverse health effects of time-weighted personal PM 2.5  exposure through inflammatory cytokines. The participants randomly received true or sham air filtration intervention for a week, and the treatment was changed after a two-week washout period. Peripheral blood samples were collected after each intervention period to measure 38 inflammatory cytokines. A linear mixed-effects model was applied to estimate the impacts of air purification or a 10 μg/m 3  PM 2.5  exposure increase on cytokines. Lag effects of PM 2.5  exposure were analyzed using single-day and moving average lag models. Air filtration reduced indoor and time-weighted average personal PM 2.5  concentrations by 69.0% (from 33.6 to 10.4 μg/m 3 ) and 40.3% (from 40.6 to 24.3 μg/m 3 ), respectively. We observed a significant association of PM 2.5  exposure with growth-regulated alpha protein (GRO-α) of -11.3% (95%CI: 17.0%, -5.4%). In the lag models, significant associations between personal PM 2.5  exposure and interleukin-1 receptor antagonist (IL-1Ra), monocyte chemotactic protein (MCP-1), and eotaxin were obtained at lag0, while associations with cytokines including vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), fibroblast growth factor-2 (FGF-2), granulocyte colony-stimulating factor (G-CSF), macrophage inflammatory protein-1β (MIP-1β), IL-4, tumor necrosis factor-α (TNF-α), and interferon-γ (IFN-γ) were noted at relatively long lagged exposure windows (lag5-lag6). No significant alteration in cytokines was observed under true air filtration intervention. Our study indicates the effectiveness of air filtration on indoor PM 2.5  reduction. PM 2.5  exposure may decrease GRO-α levels and change different cytokine levels time-varyingly. Further study is still needed to explore the mechanisms of PM 2.5  exposure on the inflammatory response.",2022,"Air filtration reduced indoor and time-weighted average personal PM 2.5  concentrations by 69.0% (from 33.6 to 10.4 μg/m 3 ) and 40.3% (from 40.6 to 24.3 μg/m 3 ), respectively.","['healthy young adults', '54 healthy college students in Beijing']","['sham air filtration', 'true or sham air filtration intervention']","['vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), fibroblast growth factor-2 (FGF-2), granulocyte colony-stimulating factor (G-CSF), macrophage inflammatory protein-1β (MIP-1β), IL-4, tumor necrosis factor-α (TNF-α), and interferon-γ (IFN-γ', 'Peripheral blood samples', 'GRO-α levels', 'cytokines', 'Air filtration reduced indoor and time-weighted average personal PM 2.5  concentrations', 'personal PM 2.5  exposure and interleukin-1 receptor antagonist (IL-1Ra), monocyte chemotactic protein (MCP-1), and eotaxin']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4042832', 'cui_str': 'Peking'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0380603', 'cui_str': 'Fibroblast Growth Factor-2'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0131875', 'cui_str': 'CXCL1 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1704264', 'cui_str': 'Interleukin 1 Inhibitor, Urine'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0282566', 'cui_str': 'Monocyte Chemotactic Proteins'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0250604', 'cui_str': 'Eotaxin-1'}]",54.0,0.0501457,"Air filtration reduced indoor and time-weighted average personal PM 2.5  concentrations by 69.0% (from 33.6 to 10.4 μg/m 3 ) and 40.3% (from 40.6 to 24.3 μg/m 3 ), respectively.","[{'ForeName': 'Fuyuan', 'Initials': 'F', 'LastName': 'Wen', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, 100191, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, 100191, China.'}, {'ForeName': 'Bingxiao', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, China.'}, {'ForeName': 'Shaowei', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': ""Department of Occupational and Environmental Health, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, China. Electronic address: zlilyepi@ccmu.edu.cn.'}]","Environmental pollution (Barking, Essex : 1987)",['10.1016/j.envpol.2022.119026']
2151,35176724,Effect of Wii Fit training on visual perception and executive function in boys with developmental coordination disorders: A randomized controlled trial.,"BACKGROUND


This paper elucidated the influence of Wii Fit training on visual perception and executive function in boys with developmental coordination disorders (DCD).
METHODS


50 school boy with DCD (Mean Age = 9.55 ± 2.24) were randomly assigned to one of two groups, Wii Fit training (intervention; n = 25) or usual school program (control; n = 25). Visual perception and executive function were measured pre-, post- (8 weeks, 3 sessions per week, 30 minute per session), using Cognitive Assessment System (CAS) and Test of Visual-Perceptual Skills-Revised (TVPS-R), respectively. Pre- and post-test changes in executive function and visual perception were calculated using one-way ANCOVA, with pre-test values as covariate and post-test values as dependent variables.
RESULTS


The findings show that the rates of change in total score of visual perception from pre to post were significantly different between groups (F(1, 47) = 660.76, P = 0.024). Similarly, intervention group showed significantly different rates of change in total score of executive function from pre to post (F (1, 47) = 26.15, P = 0.013).
CONCLUSION


Findings support that when developing interventions for the improvement or management of visual perception and executive function in children with DCD, key stakeholders should include the Wii Fit training programs.",2022,"The findings show that the rates of change in total score of visual perception from pre to post were significantly different between groups (F(1, 47) =","['children with DCD', '50 school boy with DCD (Mean Age = 9.55 ± 2.24', 'boys with developmental coordination disorders (DCD', 'boys with developmental coordination disorders']","['Wii Fit training', 'Wii Fit training (intervention; n = 25) or usual school program']","['rates of change in total score of executive function', 'Cognitive Assessment System (CAS) and Test of Visual-Perceptual Skills-Revised (TVPS-R', 'Visual perception and executive function', 'visual perception and executive function', 'total score of visual perception', 'executive function and visual perception']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",,0.0191964,"The findings show that the rates of change in total score of visual perception from pre to post were significantly different between groups (F(1, 47) =","[{'ForeName': 'Ayoub', 'Initials': 'A', 'LastName': 'Hashemi', 'Affiliation': 'Dep. of Physical Education and Sport Sciences, University of Tehran, Tehran, Iran. Electronic address: Ayoubhashemi10@ut.ac.ir.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Khodaverdi', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY, USA. Electronic address: sara.khodaverdi@ymail.com.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Zamani', 'Affiliation': 'Dep. of Physical Education and Sport Sciences, University of Ferdowsi Mashhad, Mashhad, Iran. Electronic address: h.zamani2530@gmail.com.'}]",Research in developmental disabilities,['10.1016/j.ridd.2022.104196']
2152,35176678,Mechanistic pathways of change in twice weekly versus once weekly sessions of psychotherapy for depression.,"BACKGROUND


Recently, we showed that twice weekly sessions of cognitive-behavioral therapy (CBT) and interpersonal psychotherapy (IPT) for depression lead to better and faster treatment outcomes compared to once weekly sessions (Bruijniks et al., 2020). The present study investigated which pathways of change may account for the effects of different session frequencies.
METHOD


The sample consisted of 200 patients who were randomized to CBT weekly, CBT twice weekly, IPT weekly, or IPT twice weekly. Outcome and therapy processes were measured at baseline, two weeks and monthly up to month 6 after the start of treatment. Latent change score models investigated temporal relations between change in therapy processes and change in depression and tested whether change in the therapy processes mediated the effect of session frequency on change in depression.
RESULTS


IPT skills mediated the relation between session frequency and change in depression. A decrease in depression was related to subsequent improvement in CBT skills and subsequent decrease in motivation for therapy.
CONCLUSION


The development of IPT skills may explain why a twice weekly higher session frequency is more effective in reducing depression compared to a once-weekly session frequency. Future studies should disentangle the causal effects of therapy process change throughout the course of therapy.",2022,"A decrease in depression was related to subsequent improvement in CBT skills and subsequent decrease in motivation for therapy.
",['200 patients'],"['CBT', 'cognitive-behavioral therapy (CBT) and interpersonal psychotherapy (IPT']","['session frequency and change in depression', 'CBT skills', 'depression']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",,0.0160497,"A decrease in depression was related to subsequent improvement in CBT skills and subsequent decrease in motivation for therapy.
","[{'ForeName': 'Sanne J E', 'Initials': 'SJE', 'LastName': 'Bruijniks', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Freiburg, Freiburg, Germany. Electronic address: sanne.bruijniks@psychologie.uni-freiburg.de.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Meeter', 'Affiliation': 'Vrije Universiteit Amsterdam, LEARN! Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Lemmens', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Frenk', 'Initials': 'F', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Renner', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Marcus J H', 'Initials': 'MJH', 'LastName': 'Huibers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands; Department of Psychology, University of Pennsylvania, Philadelphia, United States.'}]",Behaviour research and therapy,['10.1016/j.brat.2022.104038']
2153,35177621,BCG-induced trained immunity enhances acellular pertussis vaccination responses in an explorative randomized clinical trial.,"Acellular pertussis (aP) booster vaccines are central to pertussis immunization programs, although their effectiveness varies. The Bacille Calmette-Guérin (BCG) vaccine is a prototype inducer of trained immunity, which enhances immune responses to subsequent infections or vaccinations. While previous clinical studies have demonstrated that trained immunity can protect against heterologous infections, its effect on aP vaccines in humans is unknown. We conducted a clinical study in order to determine the immunological effects of trained immunity on pertussis vaccination. Healthy female volunteers were randomly assigned to either receive BCG followed by a booster dose of tetanus-diphteria-pertussis inactivated polio vaccine (Tdap-IPV) 3 months later (BCG-trained), BCG + Tdap-IPV concurrently, or Tdap-IPV followed by BCG 3 months later. Primary outcomes were pertussis-specific humoral, T- and B-cell responses and were quantified at baseline of Tdap-IPV vaccination and 2 weeks thereafter. As a secondary outcome in the BCG-trained cohort, ex vivo leukocyte responses were measured in response to unrelated stimuli before and after BCG vaccination. BCG vaccination 3 months prior to, but not concurrent with, Tdap-IPV improves pertussis-specific Th1-cell and humoral responses, and also increases total memory B cell responses. These responses were correlated with enhanced IL-6 and IL-1β production at the baseline of Tdap-IPV vaccination in the BCG-trained cohort. Our study demonstrates that prior BCG vaccination potentiates immune responses to pertussis vaccines and that biomarkers of trained immunity are the most reliable correlates of those responses.",2022,These responses were correlated with enhanced IL-6 and IL-1β production at the baseline of Tdap-IPV vaccination in the BCG-trained cohort.,['Healthy female volunteers'],"['Acellular pertussis (aP) booster vaccines', 'BCG', 'Tdap-IPV', 'Bacille Calmette-Guérin (BCG) vaccine', 'BCG-induced trained immunity', 'tetanus-diphteria-pertussis inactivated polio vaccine (Tdap-IPV) 3 months later (BCG-trained), BCG\u2009+\u2009Tdap-IPV concurrently, or Tdap-IPV', 'BCG vaccination']","['pertussis-specific Th1-cell and humoral responses', 'pertussis-specific humoral, T- and B-cell responses', 'enhanced IL-6 and IL-1β production', 'total memory B cell responses', 'BCG-trained cohort, ex vivo leukocyte responses']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0039614', 'cui_str': 'Tetanus'}, {'cui': 'C0031237', 'cui_str': 'Pertussis Vaccine'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0031237', 'cui_str': 'Pertussis Vaccine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242632', 'cui_str': 'T helper subset 1 cell'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]",,0.0979604,These responses were correlated with enhanced IL-6 and IL-1β production at the baseline of Tdap-IPV vaccination in the BCG-trained cohort.,"[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Gillard', 'Affiliation': 'Section Pediatric Infectious Diseases, Laboratory of Medical Immunology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Bastiaan A', 'Initials': 'BA', 'LastName': 'Blok', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases (RCI), Radboud University Medical Center, 6526 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Garza', 'Affiliation': 'Center for Molecular and Biomolecular Informatics, Radboud University Medical Center, 6526 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Prashanna Balaji', 'Initials': 'PB', 'LastName': 'Venkatasubramanian', 'Affiliation': 'Center for Molecular and Biomolecular Informatics, Radboud University Medical Center, 6526 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Elles', 'Initials': 'E', 'LastName': 'Simonetti', 'Affiliation': 'Section Pediatric Infectious Diseases, Laboratory of Medical Immunology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Eleveld', 'Affiliation': 'Section Pediatric Infectious Diseases, Laboratory of Medical Immunology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Guy A M', 'Initials': 'GAM', 'LastName': 'Berbers', 'Affiliation': 'Centre for Infectious Disease Control, National Institute of Public Health and the Environment, 3720 BA, Bilthoven, The Netherlands.'}, {'ForeName': 'Pieter G M', 'Initials': 'PGM', 'LastName': 'van Gageldonk', 'Affiliation': 'Centre for Infectious Disease Control, National Institute of Public Health and the Environment, 3720 BA, Bilthoven, The Netherlands.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Joosten', 'Affiliation': 'Laboratory for Medical Immunology, Radboud University Medical Center, 6500 HB, Nijmegen, the Netherlands.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'de Groot', 'Affiliation': 'Section Pediatric Infectious Diseases, Laboratory of Medical Immunology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'L Charlotte J', 'Initials': 'LCJ', 'LastName': 'de Bree', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases (RCI), Radboud University Medical Center, 6526 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases (RCI), Radboud University Medical Center, 6526 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Marien I', 'Initials': 'MI', 'LastName': 'de Jonge', 'Affiliation': 'Section Pediatric Infectious Diseases, Laboratory of Medical Immunology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Martijn A', 'Initials': 'MA', 'LastName': 'Huynen', 'Affiliation': 'Center for Molecular and Biomolecular Informatics, Radboud University Medical Center, 6526 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases (RCI), Radboud University Medical Center, 6526 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Dimitri A', 'Initials': 'DA', 'LastName': 'Diavatopoulos', 'Affiliation': 'Section Pediatric Infectious Diseases, Laboratory of Medical Immunology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, 6500 HB, Nijmegen, The Netherlands. dimitri.diavatopoulos@radboudumc.nl.'}]",NPJ vaccines,['10.1038/s41541-022-00438-4']
2154,35178737,Evaluating the impact of a community health worker (Promotora de Salud) program on attitudes and beliefs regarding atopic dermatitis among Spanish-speaking Latin-American caregivers.,"INTRODUCTION


Community health workers (CHWs), or promotora de salud, have an important role in healthcare education and advocacy in the Latin American community. We aimed to determine the impact of a promotora de salud program on attitudes and beliefs regarding AD management among Latin American caregivers of pediatric patients with atopic dermatitis.
METHODS


This is a sub-study of an ongoing randomized, investigator-blinded, placebo-controlled trial. Mann-Whitney U tests compared questionnaire responses in the standard education group to the promotora group.
RESULTS


Caregivers in the promotora group were more likely to state that they knew how to apply wet wraps and use bleach (sodium hypochlorite) baths at 1 month (wet wraps p = .027, bleach baths p = .005) and 3 months (wet wraps p = .005, bleach baths p < .001) demonstrating greater self-efficacy, defined as an individual's belief in their capacity to execute a certain behavior to achieve a desired outcome, compared with the standard education group.
CONCLUSIONS


Culturally competent and language concordant educational interventions may improve confidence in utilizing wet wraps and bleach baths among Latin-American caregivers of children with atopic dermatitis, which may improve AD outcomes in the Latin-American community.",2022,".005, bleach baths p < .001) demonstrating greater self-efficacy, defined as an individual's belief in their capacity to execute a certain behavior to achieve a desired outcome, compared with the standard education group.
","['Spanish-speaking Latin-American caregivers', 'children with atopic dermatitis', 'Latin American caregivers of pediatric patients with atopic dermatitis']","['promotora de salud program', 'Culturally competent and language concordant educational interventions', 'community health worker (Promotora de Salud) program', 'placebo']","['self-efficacy', 'questionnaire responses']","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0610529,".005, bleach baths p < .001) demonstrating greater self-efficacy, defined as an individual's belief in their capacity to execute a certain behavior to achieve a desired outcome, compared with the standard education group.
","[{'ForeName': 'Adrienne K', 'Initials': 'AK', 'LastName': 'Joseph', 'Affiliation': 'University of Texas Southwestern Medical Center, University of Texas Southwestern Medical School, Dallas, Texas, USA.'}, {'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Chen', 'Affiliation': 'University of Texas Southwestern Medical Center, University of Texas Southwestern Medical School, Dallas, Texas, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hassan Youssef', 'Affiliation': 'University of Texas Southwestern Medical Center, University of Texas Southwestern Medical School, Dallas, Texas, USA.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Limmer', 'Affiliation': 'University of Texas Southwestern Medical Center, University of Texas Southwestern Medical School, Dallas, Texas, USA.'}, {'ForeName': 'Faye', 'Initials': 'F', 'LastName': 'Eifert', 'Affiliation': 'Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Arturo R', 'Initials': 'AR', 'LastName': 'Dominguez', 'Affiliation': 'Departments of Internal Medicine and Dermatology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}]",Pediatric dermatology,['10.1111/pde.14917']
2155,35179521,Immediate comfort perception of 3D-printed foot orthoses in individuals with unilateral heel pain.,"BACKGROUND


Custom-made foot orthoses (FOs) play an integral part in managing foot disorders. Traditional FO fabrication is time-consuming and labor intensive. Three-dimensional (3D) printed FOs save time and cost compared with the traditional manufacturing process. To date, the differences in dimensions and comfort perception of these orthoses have not been compared in a pathological population.
OBJECTIVE


Compare the dimensions between 3D-printed and traditionally made FOs and comfort perception between 3D-printed, traditionally made, and no FOs in individuals with flatfeet and unilateral heel pain.
STUDY DESIGN


Within-subject single-blinded randomized crossover study design.
METHODS


Thirteen participants had custom-made FOs using 3D-printing and traditional processes. Orthotic lengths, widths, arch heights, and heel cup heights were compared. Participants performed walking trials under three conditions: (1) no orthoses, (2) 3D-printed orthoses, and (3) traditionally made orthoses. Comfort perception was recorded. Orthotic dimensions were compared using paired t tests, and comfort perception were compared using one-way multiple analysis of variance and Bonferroni post hoc tests.
RESULTS


Three-dimensional-printed orthoses were wider, have higher arch heights, and heel cup heights compared with traditionally made FOs (medium to large effect sizes). There was a difference in comfort perception between the three orthotic conditions, F(12,62) = 1.99, P = 0.04; Wilk Λ = 0.521, ηp2= 0.279. Post hoc tests show that there is no difference in comfort perception between the 3D-printed and traditionally made FOs. Both FOs were significantly more comfortable than no orthoses.
CONCLUSIONS


Three-dimensional printing seems to be a viable alternative orthotic fabrication option. Future studies should compare the biomechanical effects of 3D-printed and traditionally made FOs.",2022,"There was a difference in comfort perception between the three orthotic conditions, F(12,62) = 1.99, P = 0.04; Wilk Λ = 0.521, ηp2= 0.279.","['individuals with flatfeet and unilateral heel pain', 'Thirteen participants had custom-made FOs using 3D-printing and traditional processes', 'individuals with unilateral heel pain']",['3D-printed foot orthoses'],"['higher arch heights, and heel cup heights', 'Orthotic dimensions', 'Comfort perception', 'Orthotic lengths, widths, arch heights, and heel cup heights', 'comfort perception']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016202', 'cui_str': 'Flatfeet'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0231780', 'cui_str': 'Heel pain'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1522240', 'cui_str': 'Process'}]","[{'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0487742', 'cui_str': 'Width'}]",13.0,0.0627353,"There was a difference in comfort perception between the three orthotic conditions, F(12,62) = 1.99, P = 0.04; Wilk Λ = 0.521, ηp2= 0.279.","[{'ForeName': 'Malia', 'Initials': 'M', 'LastName': 'Ho', 'Affiliation': 'Department of Podiatry, School of Health, Medical and Applied Sciences, CQUniversity, Rockhampton, QLD, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Department of Podiatry, School of Health, Medical and Applied Sciences, CQUniversity, Rockhampton, QLD, Australia.'}, {'ForeName': 'Kerwin', 'Initials': 'K', 'LastName': 'Talbot', 'Affiliation': 'Department of Podiatry, School of Health, Medical and Applied Sciences, CQUniversity, Rockhampton, QLD, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Heales', 'Affiliation': 'Department of Physiotheraphy, School of Health Medical and Applied Sciences, CQUniversity, Rockhampton, QLD Australia.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Kean', 'Affiliation': 'Department of Exercise and Sports Science, School of Health, Medical and Applied Sciences, CQUniversity, Rockhampton, QLD, Australia.'}, {'ForeName': 'Pui W', 'Initials': 'PW', 'LastName': 'Kong', 'Affiliation': 'Physical Education and Sports Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stanton', 'Affiliation': 'Department of Exercise and Sports Science, School of Health, Medical and Applied Sciences, CQUniversity, Rockhampton, QLD, Australia.'}]",Prosthetics and orthotics international,['10.1097/PXR.0000000000000068']
2156,35180229,Goal management training and psychoeducation / mindfulness for treatment of executive dysfunction in Parkinson's disease: A feasibility pilot trial.,"INTRODUCTION


As there is currently no pharmacological treatment for Parkinson's Disease Mild Cognitive Impairment (PD-MCI) with executive dysfunctions, specific cognitive interventions must be investigated. Most previous studies have tested bottom-up cognitive training programs but have not shown very good results.
OBJECTIVES


The aim of this study was to test ease of implementation, differential safety and preliminary efficacy of two top-down (strategy-learning) home-based, individualized, cognitive interventions: Goal Management Training (GMT), adapted for PD-MCI (Adapted-GMT), and a psychoeducation program combined with mindfulness exercises (PSYCH-Mind).
METHODS


This was a single-blind block-randomized between-group comparative study. Twelve PD-MCI with mild executive dysfunctions were divided in four blocks and randomly assigned to any of the two interventions. The participants were included if they had PD-MCI diagnosis (no dementia), with stabilized medication. Both groups (Adapted-GMT and PSYCH-mind) received five intervention sessions each lasting 60-90 minutes for five weeks. Measures were collected at baseline, mid-point, one-week, four-week and 12-week follow-ups. Executive functions were assessed with the Dysexecutive questionnaire (DEX) and the Zoo Map Test (ZMT). Quality of life (QoL) and psychiatric symptoms were also evaluated. Repeated measures ANCOVAs (mixed linear analysis) were applied to all outcomes.
RESULTS


There was one drop out, and both interventions were feasible and acceptable. Despite the small sample size limiting statistical power, patients of both groups significantly improved executive functions per the DEX-patient (Time: F(4,36) = 2.96, p = 0.033, CI95%: 10.75-15.23) and DEX-caregiver scores (Time: F(4,36) = 6.02, p = 0.017, CI95%: 9.63-17.23). Both groups significantly made fewer errors between measurement times on the ZMT (Time: F(3,36) = 16.66, p = 0.001, CI95%: 1.07-2.93). However, QoL significantly increased only in PSYCH-Mind patients at four-week follow-up (interaction Time*Group: F(4,36) = 5.31, p = 0.002, CI95%: 15.33-25.61).
CONCLUSION


Both interventions were easily implemented and proved to be safe. Because both interventions are arguably cost-effective, these pilot findings, although promising, need to be replicated in large samples.
CLINICALTRIALS.GOV IDENTIFIER


NCT04636541.",2022,Twelve PD-MCI with mild executive dysfunctions were divided in four blocks and randomly assigned to any of the two interventions.,"[""Parkinson's disease"", 'Twelve PD-MCI with mild executive dysfunctions', ""Parkinson's Disease Mild Cognitive Impairment (PD-MCI) with executive dysfunctions"", 'participants were included if they had PD-MCI diagnosis (no dementia), with stabilized medication']","['Goal management training and psychoeducation / mindfulness', 'two top-down (strategy-learning) home-based, individualized, cognitive interventions: Goal Management Training (GMT), adapted for PD-MCI (Adapted-GMT', 'psychoeducation program combined with mindfulness exercises (PSYCH-Mind']","['executive functions', 'Executive functions', 'Dysexecutive questionnaire (DEX) and the Zoo Map Test (ZMT', 'QoL', 'Quality of life (QoL) and psychiatric symptoms', 'DEX-caregiver scores']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.029282,Twelve PD-MCI with mild executive dysfunctions were divided in four blocks and randomly assigned to any of the two interventions.,"[{'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Giguère-Rancourt', 'Affiliation': 'School of Psychology, Laval University, Quebec City, Canada.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Plourde', 'Affiliation': 'School of Psychology, Laval University, Quebec City, Canada.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Racine', 'Affiliation': 'School of Psychology, Laval University, Quebec City, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Couture', 'Affiliation': 'School of Psychology, Laval University, Quebec City, Canada.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Langlois', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Laval University, Quebec City, Canada.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dupré', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Laval University, Quebec City, Canada.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Simard', 'Affiliation': 'School of Psychology, Laval University, Quebec City, Canada.'}]",PloS one,['10.1371/journal.pone.0263108']
2157,35181380,Digital nudges to stimulate healthy and pro-environmental food choices in E-groceries.,"In response to the detrimental health- and environmental impacts of European consumers' dietary patterns, Nutri-Scores and Eco-Scores have been introduced on packages as guidance for choices. Whereas the scores are promising to improve food choices from a nutritional point of view, the scant available literature suggests very limited effects on the environmental impact of food choices. Therefore, there remains a need to explore ways to bring about improvements in both areas. As a growing share of consumers buys food groceries online, new opportunities to steer food choices are being created. This article explores the potential of several digital functionalities to further stimulate healthier and pro-environmental food choices amongst consumers. These functionalities included product recommendation agents, product scores, a real-time average impact score of the chosen food basket and a personalised social norm. Those were tested in a two-stage randomized controlled trial with 1000 Belgian household food decision makers in a mock-up E-grocery. Indices reflecting the nutritional quality (NQI) and environmental impact (EII) of the selected food baskets were calculated. The results indicate that at first, displaying a combined Nutri- and Eco-Score at product level led to improved NQI's, but not EII's. However, the scores also led to shifting behaviour in EII's when facilitated with recommendation agents. The display of the average impact scores of the selected basket and of social norms did not lead to additional improvements. Hence, a combined Nutri- and Eco-Score labelling system is recommended, but an enabling environment to consider both scores is important to realise a shift towards more healthy and environmentally friendly food choices. Apart from manifesting healthier and environmentally friendly products with a centralised labelling system, improving their accessibility should be considered at least as important for behavioural changes.",2022,Indices reflecting the nutritional quality (NQI) and environmental impact (EII) of the selected food baskets were calculated.,[],[],['nutritional quality (NQI) and environmental impact (EII) of the selected food baskets'],[],[],"[{'cui': 'C3489446', 'cui_str': 'Nutritive Quality'}, {'cui': 'C0282165', 'cui_str': 'Environmental Impact'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",1000.0,0.0877726,Indices reflecting the nutritional quality (NQI) and environmental impact (EII) of the selected food baskets were calculated.,"[{'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'De Bauw', 'Affiliation': 'KU Leuven, Department of Earth and Environmental Sciences, Division of Bio-economics, Leuven, Belgium. Electronic address: michiel.debauw@kuleuven.be.'}, {'ForeName': 'Lucia Segovia', 'Initials': 'LS', 'LastName': 'De La Revilla', 'Affiliation': 'London School of Hygiene & Tropical Medicine, Faculty of Epidemiology and Population Health, Department of Population Health, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Poppe', 'Affiliation': 'Colruyt Group, Halle, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Matthys', 'Affiliation': 'KU Leuven, Department of Chronic Diseases and Metabolism, Clinical and Experimental Endocrinology, Leuven, Belgium; University Hospitals Leuven, Department of Endocrinology, Leuven, Belgium.'}, {'ForeName': 'Liesbet', 'Initials': 'L', 'LastName': 'Vranken', 'Affiliation': 'KU Leuven, Department of Earth and Environmental Sciences, Division of Bio-economics, Leuven, Belgium.'}]",Appetite,['10.1016/j.appet.2022.105971']
2158,35182846,Early versus standard tracheostomy in ventilated patients in neurosurgical intensive care unit: A randomized controlled trial.,"INTRODUCTION


Tracheostomy is performed in patients with prolonged mechanical ventilation, who suffered catastrophic neurologic insult or upper airway obstruction. Thus far, there is no consensus on the optimal timing in performing a tracheostomy. This study aims to test whether early tracheostomy in mechanically ventilated patients in a neurosurgical setting would be associated with a shorter time of mechanical ventilation as compared to standard tracheostomy.
METHODS


This single-center prospective randomized controlled trial was conducted at University Malaya Medical Centre from July 2019 to July 2021. The likelihood of prolonged ventilation was determined objectively using the TRACH score and the patient's clinical presentation. The outcomes measured were days of mechanical ventilation post-tracheostomy, days of neuro-intensive care unit stay, and days of hospital stay. Tracheostomy-related complications were collected. The data collected were analyzed using Statistical Package for the Social Sciences version 25 for Windows (SPSS Inc., Chicago, IL, USA).
RESULTS


In all, 39 patients were randomly assigned. Of these, 20 were allocated to the early tracheostomy group (ET) and 19 were allocated to the standard tracheostomy group (ST). The demographic characteristics were similar between the groups. The primary outcome, mean (SD) days of mechanical ventilation post-tracheostomy, was statistically different in the 2 groups- early 11.9 (9.3) days, standard 18.9 (32.5) days; p = 0.014. There were comparable tracheostomy-related complications in both groups.
CONCLUSION


Early tracheostomy is associated with a shorter duration of mechanical ventilation in a neurosurgical intensive care unit setting.",2022,"There were comparable tracheostomy-related complications in both groups.
","['mechanically ventilated patients in a neurosurgical setting', 'University Malaya Medical Centre from July 2019 to July 2021', 'ventilated patients in neurosurgical intensive care unit', 'patients with prolonged mechanical ventilation, who suffered catastrophic neurologic insult or upper airway obstruction', '39 patients were randomly assigned']","['standard tracheostomy', 'standard tracheostomy group (ST']","['mechanical ventilation post-tracheostomy, days of neuro-intensive care unit stay, and days of hospital stay', 'mean (SD) days of mechanical ventilation post-tracheostomy']","[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0740852', 'cui_str': 'Upper airway obstruction'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",39.0,0.0391548,"There were comparable tracheostomy-related complications in both groups.
","[{'ForeName': 'Zhen Qiang', 'Initials': 'ZQ', 'LastName': 'Goo', 'Affiliation': 'Division of General Surgery, Department of Surgery, University Malaya Medical Centre, Kuala Lumpur, Malaysia. Electronic address: zhenqiang@ummc.edu.my.'}, {'ForeName': 'Kalai Arasu', 'Initials': 'KA', 'LastName': 'Muthusamy', 'Affiliation': 'Division of Neurosurgery, Department of Surgery, University Malaya Medical Centre, Kuala Lumpur, Malaysia. Electronic address: arasukm@ummc.edu.my.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2022.02.011']
2159,35182822,A tentative I/O curve with consciousness: Effects of multiple simultaneous ambiguous figures presentation on perceptual reversals and time estimation.,"This study was aimed at investigating mechanisms of consciousness using bistable perception. In 4 experimental conditions, 1, 2, 4 or 8 Rubin's face-vase ambiguous figures were presented for 3 min.In Experiment 1, 40 subjects looked at the center of the screen and pressed a specific key correspondent to the figure where they perceived a reversal. In Experiment 2, 32 subjects controlled with eye-tracker performed a similar task in which they pressed the spacebar whenever they perceived a reversal in any of the figures.At the end of each condition subjects estimated its duration. Results showed that changing the number of figures does not alter the number of reversals, producing a flat I/O curve between the two parameters. Estimated time lapse showed a negative correlation with the number of reversals. These findings are discussed considering the relationships between bistable perception, attention, and consciousness, as well as the time perception literature.",2022,"Results showed that changing the number of figures does not alter the number of reversals, producing a flat I/O curve between the two parameters.","['32 subjects controlled with eye-tracker', '40 subjects looked at the center of the screen and pressed a specific key correspondent to the figure where they perceived a reversal']",[],"['number of reversals, producing a flat I/O curve']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.0294729,"Results showed that changing the number of figures does not alter the number of reversals, producing a flat I/O curve between the two parameters.","[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': ""D'Anselmo"", 'Affiliation': 'Department of Psychological, Health and Territory Sciences (DiSPuTeR), ""G. d\'Annunzio"" University of Chieti-Pescara, Italy. Electronic address: a.danselmo@unich.it.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Pisani', 'Affiliation': 'Department of Psychology and Cognitive Sciences, University of Trento, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Brancucci', 'Affiliation': 'Department of Motor, Human and Health Sciences, University of Rome ""Foro Italico"", Italy.'}]",Consciousness and cognition,['10.1016/j.concog.2022.103300']
2160,35184297,Anti-KIT monoclonal antibody CDX-0159 induces profound and durable mast cell suppression in a healthy volunteer study.,"BACKGROUND


Mast cells (MC) are powerful inflammatory immune sentinel cells that drive numerous allergic, inflammatory, and pruritic disorders when activated. MC-targeted therapies are approved in several disorders, yet many patients have limited benefit suggesting the need for approaches that more broadly inhibit MC activity. MCs require the KIT receptor and its ligand stem cell factor (SCF) for differentiation, maturation, and survival. Here we describe CDX-0159, an anti-KIT monoclonal antibody that potently suppresses MCs in human healthy volunteers.
METHODS


CDX-0159-mediated KIT inhibition was tested in vitro using KIT-expressing immortalized cells and primary human mast cells. CDX-0159 safety and pharmacokinetics were evaluated in a 13-week good laboratory practice (GLP)-compliant cynomolgus macaque study. A single ascending dose (0.3, 1, 3, and 9 mg/kg), double-blinded placebo-controlled phase 1a human healthy volunteer study (n = 32) was conducted to evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159.
RESULTS


CDX-0159 inhibits SCF-dependent KIT activation in vitro. Fc modifications in CDX-0159 led to elimination of effector function and reduced serum clearance. In cynomolgus macaques, multiple high doses were safely administered without a significant impact on hematology, a potential concern for KIT inhibitors. A single dose of CDX-0159 in healthy human subjects was generally well tolerated and demonstrated long antibody exposure. Importantly, CDX-0159 led to dose-dependent, profound suppression of plasma tryptase, a MC-specific protease associated with tissue MC burden, indicative of systemic MC suppression or ablation.
CONCLUSION


CDX-0159 administration leads to systemic mast cell ablation and may represent a safe and novel approach to treat mast cell-driven disorders.",2022,CDX-0159 administration leads to systemic mast cell ablation and may represent a safe and novel approach to treat mast cell-driven disorders.,"['controlled phase 1a human healthy volunteer study (n=32', 'healthy human subjects', 'human healthy volunteers', 'healthy volunteer study']","['CDX-0159', 'double-blinded placebo']","['CDX-0159 safety and pharmacokinetics', 'serum clearance']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0007538', 'cui_str': 'Cefadroxil'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007538', 'cui_str': 'Cefadroxil'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",32.0,0.153353,CDX-0159 administration leads to systemic mast cell ablation and may represent a safe and novel approach to treat mast cell-driven disorders.,"[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Alvarado', 'Affiliation': 'Celldex Therapeutics, Hampton, New Jersey, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': 'Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universtätsmedizin Berlin, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gedrich', 'Affiliation': 'Celldex Therapeutics, Hampton, New Jersey, USA.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Seibel', 'Affiliation': 'Celldex Therapeutics, Hampton, New Jersey, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Murphy', 'Affiliation': 'Celldex Therapeutics, Hampton, New Jersey, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Crew', 'Affiliation': 'Celldex Therapeutics, Hampton, New Jersey, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Goldstein', 'Affiliation': 'Celldex Therapeutics, Hampton, New Jersey, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Crocker', 'Affiliation': 'Celldex Therapeutics, Hampton, New Jersey, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Vitale', 'Affiliation': 'Celldex Therapeutics, Hampton, New Jersey, USA.'}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Morani', 'Affiliation': 'Celldex Therapeutics, Hampton, New Jersey, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Thomas', 'Affiliation': 'Celldex Therapeutics, Hampton, New Jersey, USA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Hawthorne', 'Affiliation': 'Celldex Therapeutics, Hampton, New Jersey, USA.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Keler', 'Affiliation': 'Celldex Therapeutics, Hampton, New Jersey, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Young', 'Affiliation': 'Celldex Therapeutics, Hampton, New Jersey, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Crowley', 'Affiliation': 'Celldex Therapeutics, Hampton, New Jersey, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kankam', 'Affiliation': 'Altasciences Clinical Kansas, Overland Park, Kansas, USA.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Heath-Chiozzi', 'Affiliation': 'Celldex Therapeutics, Hampton, New Jersey, USA.'}]",Allergy,['10.1111/all.15262']
2161,35185373,Transplant Trial Watch.,,2021,,[],[],[],[],[],[],,0.0995796,,"[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': ""O'Callaghan"", 'Affiliation': 'University Hospitals Coventry and Warwickshire, Coventry, United Kingdom.'}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.3389/ti.2021.10216']
2162,35179586,Assessment of Capecitabine and Bevacizumab With or Without Atezolizumab for the Treatment of Refractory Metastatic Colorectal Cancer: A Randomized Clinical Trial.,"Importance


Cotargeting vascular endothelial growth factor and programmed cell death 1 or programmed cell death ligand 1 may produce anticancer activity in refractory metastatic colorectal cancer (mCRC). The clinical benefit of atezolizumab combined with chemotherapy and bevacizumab remains unclear for the treatment of mCRC.
Objectives


To assess whether the addition of atezolizumab to capecitabine and bevacizumab therapy improves progression-free survival (PFS) among patients with refractory mCRC and to perform exploratory analyses among patients with microsatellite-stable (MSS) disease and liver metastasis.
Design, Setting, and Participants


This double-blind phase 2 randomized clinical trial enrolled 133 patients between September 25, 2017, and June 28, 2018 (median duration of follow-up for PFS, 20.9 months), with data cutoff on May 4, 2020. The study was conducted at multiple centers through the Academic and Community Cancer Research United network. Adult patients with mCRC who experienced disease progression while receiving fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and anti-epidermal growth factor receptor antibody therapy (if the patient had a RAS wild-type tumor) were included.
Interventions


Patients were randomized (2:1) to receive capecitabine (850 or 1000 mg/m2) twice daily on days 1 to 14 and bevacizumab (7.5 mg/kg) on day 1 plus either atezolizumab (1200 mg; investigational group) or placebo (placebo group) on day 1 of each 21-day cycle.
Main Outcomes and Measures


The primary end point was PFS; 110 events were required to detect a hazard ratio (HR) of 0.65 with 80% power (1-sided α = .10). Secondary end points were objective response rate, overall survival (OS), and toxic effects.
Results


Of 133 randomized patients, 128 individuals (median age, 58.0 years [IQR, 51.0-65.0 years]; 77 men [60.2%]) were assessed for efficacy (82 in the investigational group and 46 in the placebo group). Overall, 15 patients (11.7%) self-identified as African American or Black, 8 (6.3%) as Asian, 1 (0.8%) as Pacific Islander, 101 (78.9%) as White, 1 (0.8%) as multiple races (Asian, Native Hawaiian/Pacific Islander, and White), and 2 (1.6%) as unknown race or unsure of race. Microsatellite-stable disease was present in 110 patients (69 in the investigational group and 41 in the placebo group). Median PFS was 4.4 months (95% CI, 4.1-6.4 months) in the investigational group and 3.6 months (95% CI, 2.2-6.2 months) in the placebo group (1-sided log-rank P = .07, a statistically significant result; HR, 0.75; 95% CI, 0.52-1.09). Among patients with MSS and proficient mismatch repair, the HR for PFS was 0.66 (95% CI, 0.44-0.99). The most common grade 3 or higher treatment-related adverse events in the investigational vs placebo groups were hypertension (6 patients [7.0%] vs 2 patients [4.3%]), diarrhea (6 patients [7.0%] vs 2 patients [4.3%]), and hand-foot syndrome (6 patients [7.0%] vs 2 patients [4.3%]). One treatment-related death occurred in the investigational group. In the investigational group, the response rate was higher among patients without liver metastasis (3 of 13 individuals [23.1%]) vs with liver metastasis (4 of 69 individuals [5.8%]). The benefit of atezolizumab for PFS and OS was greater among patients without vs with liver metastasis (primary analysis of PFS: HR, 0.63 [95% CI, 0.27-1.47] vs 0.77 [95% CI, 0.51-1.17]; OS: HR, 0.33 [95% CI, 0.11-1.02] vs 1.14 [95% CI, 0.72-1.81]).
Conclusions and Relevance


In this randomized clinical trial, the addition of atezolizumab to capecitabine and bevacizumab therapy provided limited (ie, not clinically meaningful) clinical benefit. Patients with MSS and proficient mismatch repair tumors and those without liver metastasis benefited more from dual inhibition of the vascular endothelial growth factor and programmed cell death 1 or programmed cell death ligand 1 pathways.
Trial Registration


ClinicalTrials.gov Identifier: NCT02873195.",2022,Microsatellite-stable disease was present in 110 patients (69 in the investigational group and 41 in the placebo group).,"['Refractory Metastatic Colorectal Cancer', 'patients with refractory mCRC and to perform exploratory analyses among patients with microsatellite-stable (MSS) disease and liver metastasis', 'refractory metastatic colorectal cancer (mCRC', '15 patients (11.7%) self-identified as African American or Black, 8 (6.3%) as Asian, 1 (0.8%) as Pacific Islander, 101 (78.9%) as White, 1 (0.8%) as multiple races (Asian, Native Hawaiian/Pacific Islander, and White), and 2 (1.6%) as unknown race or unsure of race', 'multiple centers through the Academic and Community Cancer Research United network', '133 patients between September 25, 2017, and June 28, 2018 (median duration of follow-up for PFS, 20.9 months), with data cutoff on May 4, 2020', 'Patients with MSS and proficient mismatch repair tumors and those without liver metastasis', '133 randomized patients, 128 individuals (median age, 58.0 years [IQR, 51.0-65.0 years]; 77 men [60.2%]) were assessed for efficacy (82 in the investigational group and 46 in the placebo group', '110 patients (69 in the investigational group and 41 in the placebo group', 'Adult patients with mCRC who experienced disease progression while receiving']","['placebo', 'atezolizumab combined with chemotherapy and bevacizumab', 'fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and anti-epidermal growth factor receptor antibody therapy', 'placebo (placebo', 'Capecitabine and Bevacizumab With or Without Atezolizumab', 'bevacizumab', 'atezolizumab to capecitabine and bevacizumab', 'capecitabine', 'atezolizumab to capecitabine and bevacizumab therapy', 'atezolizumab']","['hypertension', 'progression-free survival (PFS', 'diarrhea', 'HR for PFS', 'objective response rate, overall survival (OS), and toxic effects', 'death', 'response rate', 'PFS; 110 events were required to detect a hazard ratio (HR', 'Microsatellite-stable disease', 'adverse events', 'Median PFS']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1519302', 'cui_str': 'Short Tandem Repeats'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0242191', 'cui_str': 'Pacific Island Americans'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0337920', 'cui_str': 'Hawaiians'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1155661', 'cui_str': 'DNA mismatch repair'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C1519302', 'cui_str': 'Short Tandem Repeats'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",133.0,0.644756,Microsatellite-stable disease was present in 110 patients (69 in the investigational group and 41 in the placebo group).,"[{'ForeName': 'Niharika B', 'Initials': 'NB', 'LastName': 'Mettu', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Department of Quantitative Health Sciences, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Tyler J', 'Initials': 'TJ', 'LastName': 'Zemla', 'Affiliation': 'Department of Quantitative Health Sciences, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Thorvardur R', 'Initials': 'TR', 'LastName': 'Halfdanarson', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles.'}, {'ForeName': 'Rimini A', 'Initials': 'RA', 'LastName': 'Breakstone', 'Affiliation': 'Department of Medical Oncology, Lifespan Cancer Institute, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Boland', 'Affiliation': 'Department of Medical Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick.'}, {'ForeName': 'Oxana V', 'Initials': 'OV', 'LastName': 'Crysler', 'Affiliation': 'Department of Medical Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology and Medical Oncology, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Nixon', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bolch', 'Affiliation': 'Department of Gastrointestinal Oncology Clinical Research, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Elsing', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Herbert I', 'Initials': 'HI', 'LastName': 'Hurwitz', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Marwan G', 'Initials': 'MG', 'LastName': 'Fakih', 'Affiliation': 'Department of Medical Oncology, City of Hope National Medical Center, Duarte, California.'}, {'ForeName': 'Tanios', 'Initials': 'T', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Phoenix, Arizona.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.49040']
2163,35179802,INTERmittent FASTing in people with insulin-treated type 2 diabetes mellitus - the INTERFAST-2 study protocol.,"AIM


Intermittent fasting, a dietary intervention of alternate eating and fasting, has gained popularity in people trying to lose weight. Intermittent fasting could provide an alternative to classic caloric restriction in people with type 2 diabetes mellitus. The aim of the study is to determine the impact of a 12-week intermittent fasting regimen compared with usual care in people with type 2 diabetes mellitus receiving insulin therapy.
METHODS


This open, single-centre, randomized controlled trial investigates participants with type 2 diabetes mellitus on insulin therapy and a glycated haemoglobin A1c (HbA1c) of ≥53 mmol/mol (≥7.0%) and a minimum insulin dose of 0.3 IU/kg body weight per day. Participants are randomized in a 1:1 ratio to either 12 weeks of intermittent fasting or the standard care group. All participants receive dietary counselling, continuous glucose monitoring, measurement of the resting metabolic rate, an oral glucose tolerance test, body composition measurement via dual-energy X-ray absorptiometry and stool samples for microbiome analyses at the beginning and at the end of the intervention. Two co-primary outcomes (analysed in hierarchical order) were chosen for the study: (i) the difference in the change of HbA1c from baseline to 12 weeks and (ii) the difference in the number of participants achieving a combined end point encompassing a body weight reduction of at least 2%, an insulin dose reduction of at least 10% and an absolute HbA1c reduction of at least 3 mmol/mol (0.3%) between the two groups.",2022,"the difference in the number of participants achieving a combined endpoint encompassing a body weight reduction of at least 2%, an insulin dose reduction of at least 10% and an absolute HbA1c reduction of at least 3 mmol/mol (0.3%) between the two groups.","['participants with type 2 diabetes mellitus on insulin therapy and a glycated haemoglobin A1c (HbA1c) of ≥53 mmol/mol (≥7.0 %) and a minimum insulin dose of 0.3 IU/kg body weight per day', 'people with type 2 diabetes mellitus ', 'people with insulin-treated type 2 diabetes mellitus', 'people with type 2 diabetes mellitus receiving insulin therapy']","['INTERmittent FASTing', 'dietary counselling, continuous glucose monitoring (CGM', 'intermittent fasting or the standard care group']","['body weight reduction', 'oral glucose tolerance test (oGTT), body composition measurement via dual-energy x-ray absorptiometry (DXA) and stool samples']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0560608', 'cui_str': 'IU/kg body weight'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0342266', 'cui_str': 'Insulin treated type 2 diabetes mellitus'}]","[{'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}]",,0.0564198,"the difference in the number of participants achieving a combined endpoint encompassing a body weight reduction of at least 2%, an insulin dose reduction of at least 10% and an absolute HbA1c reduction of at least 3 mmol/mol (0.3%) between the two groups.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Obermayer', 'Affiliation': 'Interdisciplinary Metabolic Medicine Trials Unit, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Norbert J', 'Initials': 'NJ', 'LastName': 'Tripolt', 'Affiliation': 'Interdisciplinary Metabolic Medicine Trials Unit, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'Pferschy', 'Affiliation': 'Interdisciplinary Metabolic Medicine Trials Unit, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Kojzar', 'Affiliation': 'Interdisciplinary Metabolic Medicine Trials Unit, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacan', 'Affiliation': 'CBmed - Center for Biomarker Research in Medicine, Graz, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schauer', 'Affiliation': 'Interdisciplinary Metabolic Medicine Trials Unit, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Aziz', 'Affiliation': 'Interdisciplinary Metabolic Medicine Trials Unit, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Abderrahim', 'Initials': 'A', 'LastName': 'Oulhaj', 'Affiliation': 'Department of Epidemiology and Public Health, College of Medicine and Health Sciences, Khalifa University, Abu Dhabi, UAE.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Aberer', 'Affiliation': 'Interdisciplinary Metabolic Medicine Trials Unit, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Caren', 'Initials': 'C', 'LastName': 'Sourij', 'Affiliation': 'Division of Cardiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Obermayer-Pietsch', 'Affiliation': 'Endocrinology Lab Platform, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Stadlbauer', 'Affiliation': 'CBmed - Center for Biomarker Research in Medicine, Graz, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Sourij', 'Affiliation': 'Interdisciplinary Metabolic Medicine Trials Unit, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14813']
2164,35180137,Physician recommended school accommodations and student outcomes following a mild traumatic brain injury among youth with persistent post-concussive symptoms.,"BACKGROUND


Post-concussion return-to-learn (RTL) guidelines include implementation of school accommodations. Yet, little is known about physician recommendations for school accommodations and their impact, particularly among youth experiencing persistent post-concussive symptoms (PPCS).
OBJECTIVE


We examined the association between physician recommended school accommodations and student outcomes among youth experiencing PPCS.
METHODS


Data from a randomized comparative effectiveness trial was used. Physician recommended school accommodations (≤90 days post-injury) were collected via chart abstraction. Grade point average was extracted from school records. Reports of problems at school, concussion symptoms, health-related quality of life (HRQOL), anxiety symptoms, and depressive symptoms were collected by survey (at baseline, three months, and 12 months post study entry).
RESULTS


Of 200 participants (M_age = 14.7, 62% female), 86% were recommended school accommodations. Number of recommended school accommodations was positively associated with number of school problems at three months (aRR 1.18, 95% CI:1.12-1.24) and 12 months (aRR 1.11, 95% CI:1.05-1.18). No significant associations were found between recommended school accommodations and GPA, HRQOL, anxiety symptoms, or depressive symptoms.
CONCLUSIONS


Physicians recommend more school accommodations for students experiencing more school problems post-concussion. Appropriate implementation of RTL recommendations made by physicians by fostering partnerships among physicians, students, and schools may be needed to achieve student-centered RTL.",2022,"Number of recommended school accommodations was positively associated with number of school problems at three months (aRR 1.18, 95% CI:1.12-1.24) and 12 months (aRR 1.11, 95% CI:1.05-1.18).","['mild traumatic brain injury among youth with persistent post-concussive symptoms', 'Of 200 participants (Mage\u200a=\u200a14.7, 62% female', 'youth experiencing PPCS']",['Post-concussion return-to-learn (RTL'],"['school accommodations and GPA, HRQOL, anxiety symptoms, or depressive symptoms', 'number of school problems', 'concussion symptoms, health-related quality of life (HRQOL), anxiety symptoms, and depressive symptoms']","[{'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0017955', 'cui_str': 'Glycophorin A'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0000873', 'cui_str': 'Academic problem'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",200.0,0.0420326,"Number of recommended school accommodations was positively associated with number of school problems at three months (aRR 1.18, 95% CI:1.12-1.24) and 12 months (aRR 1.11, 95% CI:1.05-1.18).","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Takagi-Stewart', 'Affiliation': 'Harborview Injury Prevention and Research Center, Seattle, WA, USA.'}, {'ForeName': 'Ashleigh M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': ""Seattle Children's ResearchInstitute, Seattle, WA, USA.""}, {'ForeName': 'Mallory B', 'Initials': 'MB', 'LastName': 'Smith', 'Affiliation': 'Harborview Injury Prevention and Research Center, Seattle, WA, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Harborview Injury Prevention and Research Center, Seattle, WA, USA.'}, {'ForeName': 'Lyscha A', 'Initials': 'LA', 'LastName': 'Marcynyszyn', 'Affiliation': ""Seattle Children's ResearchInstitute, Seattle, WA, USA.""}, {'ForeName': 'Douglas F', 'Initials': 'DF', 'LastName': 'Zatzick', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'McCarty', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Frederick P', 'Initials': 'FP', 'LastName': 'Rivara', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Monica S', 'Initials': 'MS', 'LastName': 'Vavilala', 'Affiliation': 'Harborview Injury Prevention and Research Center, Seattle, WA, USA.'}]",NeuroRehabilitation,['10.3233/NRE-210324']
2165,35180184,The Effects of High-Intensity Functional Training Compared with Traditional Strength or Endurance Training on Physical Performance in Adolescents: A Randomized Controlled Trial.,,2022,,['Adolescents'],['High-Intensity Functional Training Compared with Traditional Strength or Endurance Training'],['Physical Performance'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0311057,,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gavanda', 'Affiliation': 'Department of Fitness and Health, IST University of Applied Sciences, Düsseldorf, Germany.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Isenmann', 'Affiliation': 'Department of Fitness and Health, IST University of Applied Sciences, Düsseldorf, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Geisler', 'Affiliation': 'Department of Fitness and Health, IST University of Applied Sciences, Düsseldorf, Germany.'}, {'ForeName': 'Avery', 'Initials': 'A', 'LastName': 'Faigenbaum', 'Affiliation': 'Department of Health and Exercise Science, The College of New Jersey, Ewing, New Jersey; and.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zinner', 'Affiliation': 'Department of Sport, University of Applied Sciences for Police and Administration of Hesse, Wiesbaden, Germany.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000004221']
2166,35180612,Mindfulness improves theory of mind in people experiencing psychosis: A pilot randomized clinical trial.,Impaired Theory of Mind (ToM) ability is a core feature of psychotic disorders that challenges psychosis treatment. We aimed to explore the effect of a Mindfulness-Based Intervention (MBI) on ToM ability in a randomized clinical trial (RCT). A sample of 36 participants diagnosed with psychotic disorder were recruited from a community center and randomly allocated to Integrated Rehabilitation Treatment (IRT) or IRT+MBI. ToM skills were assessed through the Hinting Test and the Reading the Mind in the Eyes Test (RMET). IRT+MBI scored higher in RMET than IRT at posttreatment. MBI is a promising tool for improving ToM ability in psychosis.,2022,IRT+MBI scored higher in RMET than IRT at posttreatment.,"['36 participants diagnosed with psychotic disorder', 'people experiencing psychosis']","['Mindfulness-Based Intervention (MBI', 'Integrated Rehabilitation Treatment (IRT) or IRT+MBI', 'MBI']",['ToM skills'],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0935573', 'cui_str': 'Theory of Mind'}]",36.0,0.193971,IRT+MBI scored higher in RMET than IRT at posttreatment.,"[{'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'López-Navarro', 'Affiliation': 'Department of Psychology, EvoCog Group, IFISC, Associated Unit to CSIC, University of Balearic Islands, Guillem Cifre Building, Ctra Valldemossa km 7,5, Balearic Islands, Spain; Programa Riojano de Investigación en Salud Mental (PRISMA), University of La Rioja, Logroño, Spain. Electronic address: Emilio.lopez@uib.es.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Fonseca-Pedrero', 'Affiliation': 'Programa Riojano de Investigación en Salud Mental (PRISMA), University of La Rioja, Logroño, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Errasti', 'Affiliation': 'Department of Psychology, University of Oviedo, Principality of Asturias, Oviedo, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Al-Halabí', 'Affiliation': 'Department of Psychology, University of Oviedo, Principality of Asturias, Oviedo, Spain.'}]",Psychiatry research,['10.1016/j.psychres.2022.114440']
2167,35180611,A follow-up study on treatment effects of cognitive-behavioral therapy on social anxiety disorder: Impact of COVID-19 fear during post-lockdown period.,"There is a paucity of research on the role of COVID-19 related fear and lockdown on social anxiety disorder (SAD). In a follow-up study during post-lockdown period, we compared social anxiety of individuals with SAD who received cognitive-behavioral therapy (CBT) versus psychoeducational-supportive therapy (PST) before the COVID-19 pandemic, and the impact of COVID-19 related fear. Social anxiety severity was rated by the Social Phobia Inventory (SPIN) at pre-intervention, post-intervention, and post-lockdown periods. Fear of COVID-19 was assessed during the post-lockdown period. The treatment effects in the CBT group (n = 33) were significantly better than the PST group (n = 32) at post-intervention; this was maintained at 14-months following intervention despite COVID-related lockdown. In the PST group, there was no change following the intervention; and the social phobia increased after lockdown. The CBT group had significantly less COVID-19 related fear than the PST group. Social anxiety was positively correlated with fear of COVID-19; and individuals with comorbidities had significantly more fear. Using the hierarchical multiple regression, SPIN post-intervention, COVID-19 fear, and duration of SAD predicted social anxiety severity during the post-lockdown period. In conclusion, the effect of CBT for SAD was maintained through lockdown and was associated with significantly less COVID-19 related fear.",2022,The treatment effects in the CBT group (n = 33) were significantly better than the PST group (n = 32) at post-intervention; this was maintained at 14-months following intervention despite COVID-related lockdown.,"['social anxiety disorder', 'individuals with SAD who received']","['CBT', 'cognitive-behavioral therapy', 'PST', 'cognitive-behavioral therapy (CBT) versus psychoeducational-supportive therapy (PST']","['social phobia', 'Social Phobia Inventory (SPIN', 'fear', 'COVID-19 fear, and duration of SAD predicted social anxiety severity', 'Fear of COVID-19', 'Social anxiety severity', 'Social anxiety']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C2919658', 'cui_str': 'Social phobia inventory'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",33.0,0.00732716,The treatment effects in the CBT group (n = 33) were significantly better than the PST group (n = 32) at post-intervention; this was maintained at 14-months following intervention despite COVID-related lockdown.,"[{'ForeName': 'Narendra Nath', 'Initials': 'NN', 'LastName': 'Samantaray', 'Affiliation': 'Dept. of Clinical Psychology, School of Medical and Paramedical Science, Mizoram University, Aizawl, India. Electronic address: narendra.samantaray@gmail.com.'}, {'ForeName': 'Nilamadhab', 'Initials': 'N', 'LastName': 'Kar', 'Affiliation': 'Consultant Psychiatrist and College Tutor, Black Country Healthcare NHS Foundation Trust, Wolverhampton, England. Electronic address: n.kar@nhs.net.'}, {'ForeName': 'Subhransu Ranjan', 'Initials': 'SR', 'LastName': 'Mishra', 'Affiliation': 'SCB Medical College, Cuttack, India.'}]",Psychiatry research,['10.1016/j.psychres.2022.114439']
2168,35180478,Effect of five nights of sleep extension on peripheral vascular function: a randomized crossover investigation into long sleep duration.,"Long sleep duration, defined as ≥9 h, is associated with increased cardiovascular mortality. We sought to determine the effect of sleep extension on peripheral vascular health. Twelve middle-aged adults were randomly assigned to spend five nights with 8 h (control) or 10+ hours time in bed (TIB) in a crossover fashion. Sleep was assessed using wrist actigraphy. Peak reactive hyperemia in the forearm was measured using venous-occlusion plethysmography as an index of microvascular vasodilation. Nighttime and morning blood pressure was recorded along with pulse wave velocity (arterial stiffness). Average sleep duration was 7.1 ± 0.3 and 9.3 ± 0.3 h for 8 and 10+ hours TIB (P < 0.001), respectfully. On average, sleep was extended by 127 ± 29 min with nine participants reaching average sleep durations >9 h. Extended sleep did not change nighttime or morning blood pressure, or pulse wave velocity (all P > 0.05). In contrast, peak forearm vascular conductance (FVC, 0.27 ± 0.08 vs. 0.23 ± 0.07 ml/100 ml/min/mmHg, P = 0.02) and total excess blood flow (28 ± 9 vs. 24 ± 11 ml/100 ml, P < 0.01) were increased following sleep extension. The change in FVC and total excess blood flow were inversely correlated with the change in wake after sleep onset and TIB (both r = -0.62, P < 0.05), but not with sleep duration. These results demonstrate that extended time in bed accompanied by long sleep durations does not impair peripheral vascular function, but rather, may increase microvasculature vasodilatory capacity in midlife adults.",2022,"In contrast, peak forearm vascular conductance (FVC, 0.27 ± 0.08 vs. 0.23 ± 0.07 ml/100 ml/min/","['Twelve middle-aged adults', '11 ml/100', 'midlife adults']","['sleep extension', 'spend five nights with 8\xa0h (control) or 10+ hours time in bed (TIB']","['Peak reactive hyperemia', 'sleep extension', 'cardiovascular mortality', 'change in FVC and total excess blood flow', 'peripheral vascular health', 'total excess blood flow (28\xa0±', 'peripheral vascular function', 'peak forearm vascular conductance', 'Average sleep duration', 'Nighttime and morning blood pressure', 'Sleep', 'change nighttime or morning blood pressure, or pulse wave velocity', 'microvasculature vasodilatory capacity']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0243079', 'cui_str': 'microvasculature'}]",,0.0390383,"In contrast, peak forearm vascular conductance (FVC, 0.27 ± 0.08 vs. 0.23 ± 0.07 ml/100 ml/min/","[{'ForeName': 'Joaquin U', 'Initials': 'JU', 'LastName': 'Gonzales', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA. Electronic address: joaquin.gonzales@ttu.edu.'}, {'ForeName': 'Cayla', 'Initials': 'C', 'LastName': 'Clark', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': 'Department of Environmental Toxicology, Texas Tech University, Lubbock, TX, USA.'}]",Sleep medicine,['10.1016/j.sleep.2022.01.021']
2169,35180445,Effects of body ownership illusion during exposure to disgusting stimuli.,"BACKGROUND


The Rubber Hand Illusion (RHI) refers to the feeling of ownership of a rubber hand by synchronously stroking the rubber hand and the own hand of a person. Previous research has shown that RHI can be used to simulate skin contact with a disgust-eliciting stimulus. We used a primary disgust elicitor (a living maggot) to replicate this finding and to gather data on disgust habituation during RHI, and effects on in-vivo exposure.
METHODS


A total of 82 healthy participants (25 males, 57 females) were randomly assigned to one of two conditions; synchronous stroking or asynchronous stroking (control condition) of the rubber/own hand. Subsequently, a maggot was placed on the rubber hand for five minutes. Participants rated experienced disgust at the beginning and end of the exposure. They were also asked if the maggot could be placed on their own hand.
RESULTS


Synchronous stroking successfully elicited RHI, which was associated with higher disgust ratings for the maggot at the beginning of exposure compared to asynchronous stroking. The two conditions did not differ in disgust habituation and the willingness to expose the own hand to the maggot.
CONCLUSION


RHI successfully simulated skin contact with a disgust stimulus. Future studies should apply longer exposure intervals and test individuals with higher disgust propensity to detect possible RHI effects on disgust habituation.",2022,"The two conditions did not differ in disgust habituation and the willingness to expose the own hand to the maggot.
","['82 healthy participants (25 males, 57 females']","['Rubber Hand Illusion (RHI', 'synchronous stroking or asynchronous stroking (control condition) of the rubber/own hand', 'body ownership illusion']","['disgust ratings', 'disgust habituation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0020903', 'cui_str': 'Illusions'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0029981', 'cui_str': 'Ownership'}]","[{'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}]",82.0,0.0632322,"The two conditions did not differ in disgust habituation and the willingness to expose the own hand to the maggot.
","[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Unger', 'Affiliation': 'Institute of Psychology, University of Graz, Universitätsplatz 2, 8010 Graz, Austria. Electronic address: isabella.unger@uni-graz.at.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schienle', 'Affiliation': 'Institute of Psychology, University of Graz, Universitätsplatz 2, 8010 Graz, Austria. Electronic address: anne.schienle@uni-graz.at.'}]",Consciousness and cognition,['10.1016/j.concog.2022.103285']
2170,35180419,Whole blood versus red cell concentrates for children with severe anaemia: a secondary analysis of the Transfusion and Treatment of African Children (TRACT) trial.,"BACKGROUND


The TRACT trial established the timing of transfusion in children with uncomplicated anaemia (haemoglobin 4-6 g/dL) and the optimal volume (20 vs 30 mL/kg whole blood or 10 vs 15 mL/kg red cell concentrates) for transfusion in children admitted to hospital with severe anaemia (haemoglobin <6 g/dL) on day 28 mortality (primary endpoint). Because data on the safety of blood components are scarce, we conducted a secondary analysis to examine the safety and efficacy of different pack types (whole blood vs red cell concentrates) on clinical outcomes.
METHODS


This study is a secondary analysis of the TRACT trial data restricted to those who received an immediate transfusion (using whole blood or red cell concentrates). TRACT was an open-label, multicentre, factorial, randomised trial conducted in three hospitals in Uganda (Soroti, Mbale, and Mulago) and one hospital in Malawi (Blantyre). The trial enrolled children aged between 2 months and 12 years admitted to hospital with severe anaemia (haemoglobin <6 g/dL). The pack type used (supplied by blood banks) was based only on availability at the time. The outcomes were haemoglobin recovery at 8 h and 180 days, requirement for retransfusion, length of hospital stay, changes in heart and respiratory rates until day 180, and the main clinical endpoints (mortality until day 28 and day 180, and readmission until day 180), measured using multivariate regression models.
FINDINGS


Between Sept 17, 2014, and May 15, 2017, 3199 children with severe anaemia were enrolled into the TRACT trial. 3188 children were considered in our secondary analysis. The median age was 37 months (IQR 18-64). Whole blood was the first pack provided for 1632 (41%) of 3992 transfusions. Haemoglobin recovery at 8 h was significantly lower in those who received packed cells or settled cells than those who received whole blood, with a mean of 1·4 g/dL (95% CI -1·6 to -1·1) in children who received 30 mL/kg and -1·3 g/dL (-1·5 to -1·0) in those who received 20 mL/kg packed cells versus whole blood, and -1·5 g/dL (-1·7 to -1·3) in those who received 30 mL/kg and -1·0 g/dL (-1·2 to -0·9) in those who received 20 mL/kg settled cells versus whole blood (overall p<0·0001). Compared to whole blood, children who received blood as packed or settled cells in their first transfusion had higher odds of receiving a second transfusion (odds ratio 2·32 [95% CI 1·30 to 4·12] for packed cells and 2·97 [2·18 to 4·05] for settled cells; p<0·001) and longer hospital stays (hazard ratio 0·94 [95% CI 0·81 to 1·10] for packed cells and 0·86 [0·79 to 0·94] for settled cells; p=0·0024). There was no association between the type of blood supplied for the first transfusion and mortality at 28 days or 180 days, or readmission to hospital for any cause. 823 (26%) of 3188 children presented with severe tachycardia and 2077 (65%) with tachypnoea, but these complications resolved over time. No child developed features of confirmed cardiopulmonary overload.
INTERPRETATION


Our study suggests that the use of packed or settled cells rather than whole blood leads to additional transfusions, increasing the use of a scarce resource in most of sub-Saharan Africa. These findings have substantial cost implications for blood transfusion and health services. Nevertheless, a clinical trial comparing whole blood transfusion with red cell concentrates might be needed to inform policy makers.
FUNDING


UK Medical Research Council (MRC) and the Department for International Development.
TRANSLATION


For the French translation of the abstract see Supplementary Materials section.",2022,"Haemoglobin recovery at 8 h was significantly lower in those who received packed cells or settled cells than those who received whole blood, with a mean of 1·4 g/dL (95% CI -1·6 to -1·1) in children who received 30 mL/kg and -1·3","['three hospitals in Uganda (Soroti, Mbale, and Mulago) and one hospital in Malawi (Blantyre', 'trial enrolled children aged between 2 months and 12 years admitted to hospital with severe anaemia (haemoglobin <6 g/dL', 'children with uncomplicated anaemia (haemoglobin 4-6 g/dL) and the optimal volume (20 vs 30 mL/kg whole blood or 10 vs 15 mL/kg red cell concentrates) for transfusion in children admitted to hospital with severe anaemia (haemoglobin <6 g/dL) on day 28 mortality (primary endpoint', '3199 children with severe anaemia were enrolled into the TRACT trial', '3188 children', 'children with severe anaemia']","['Whole blood versus red cell concentrates', 'TRACT']","['Haemoglobin recovery', 'severe tachycardia', 'haemoglobin recovery at 8 h and 180 days, requirement for retransfusion, length of hospital stay, changes in heart and respiratory rates', 'longer hospital stays']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",3188.0,0.436389,"Haemoglobin recovery at 8 h was significantly lower in those who received packed cells or settled cells than those who received whole blood, with a mean of 1·4 g/dL (95% CI -1·6 to -1·1) in children who received 30 mL/kg and -1·3","[{'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'George', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Uyoga', 'Affiliation': 'Kenya Medical Research Institute, Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Bridon', 'Initials': 'B', 'LastName': ""M'baya"", 'Affiliation': 'Malawi Blood Transfusion Services, Blantyre, Malawi.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Kyeyune Byabazair', 'Affiliation': 'Uganda Blood Transfusion Services, Kampala, Uganda.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kiguli', 'Affiliation': 'Department of Paediatrics and Child Health, School of Medicine, Makerere University, Uganda.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Olupot-Olupot', 'Affiliation': 'Busitema University Faculty of Health Sciences, Mbale Regional Referral Hospital, Mbale, Uganda; Mbale Clinical Research Institute, Mbale, Uganda.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': 'Department of Paediatrics and Child Health, School of Medicine, Makerere University, Uganda.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Chagaluka', 'Affiliation': 'College of Medicine, Malawi-Liverpool-Wellcome Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Alaroker', 'Affiliation': 'Soroti Regional Referral Hospital, Soroti, Uganda.'}, {'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Williams', 'Affiliation': 'Kenya Medical Research Institute, Wellcome Trust Research Programme, Kilifi, Kenya; Department of Infectious Disease, Institute of Global Health and Innovation, Imperial College London, London, UK.'}, {'ForeName': 'Imelda', 'Initials': 'I', 'LastName': 'Bates', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Mbanya', 'Affiliation': 'Haematology and Transfusion Service, Centre Hospitalier et Universitaire, Yaounde, Cameroon.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Maitland', 'Affiliation': 'Kenya Medical Research Institute, Wellcome Trust Research Programme, Kilifi, Kenya; Department of Infectious Disease, Institute of Global Health and Innovation, Imperial College London, London, UK. Electronic address: k.maitland@imperial.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(21)00565-9']
2171,35183000,Cosmetic outcomes of skin closure with tissue adhesive or staples in repeated cesarean section: A randomized controlled trial.,"OBJECTIVE


To compare scar quality associated with metal staples or tissue adhesive for closure of the skin incision at repeat cesarean delivery (CD).
STUDY DESIGN


Single-center Randomized Controlled Trial (ClinicalTrial.gov ID: NCT04302597), including women undergoing repeat CD using metal staples or 2- octylcyanoacrylate for closure of the skin incision. Patients were randomized to have skin closure following CD with either staples or tissue adhesive. Scar quality was evaluated 2 and 6 months postoperatively using the Vancouver Scar Scale, the Patient and Observer Scar Assessment Scale (POSAS), and a visual analog scale.
RESULTS


Of the 66 patients who were recruited, 55 successfully completed the study. The duration of surgery was comparable in both groups. A partial wound dehiscence occurred in one patient who had tissue adhesive closure. No difference in subjective and objective scar cosmesis rating was found between tissue adhesive and staples groups at either 2 months or 6 months.
CONCLUSIONS


In women undergoing CD, stapled wounds and those closed with tissue adhesive result in equivalent cosmetic appearance of the scar.",2022,"No difference in subjective and objective scar cosmesis rating was found between tissue adhesive and staples groups at either 2 months or 6 months.
","['women undergoing repeat CD using metal staples or 2- octylcyanoacrylate for closure of the skin incision', '66 patients who were recruited', 'repeated cesarean section']","['skin closure with tissue adhesive or staples', 'skin closure following CD with either staples or tissue adhesive']","['Scar quality', 'partial wound dehiscence', 'scar quality', 'Vancouver Scar Scale, the Patient and Observer Scar Assessment Scale (POSAS), and a visual analog scale', 'duration of surgery', 'subjective and objective scar cosmesis rating']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0391770', 'cui_str': '2-octyl cyanoacrylate'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206101', 'cui_str': 'Repeat Cesarean Section'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0040277', 'cui_str': 'Tissue adhesives'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",66.0,0.0261003,"No difference in subjective and objective scar cosmesis rating was found between tissue adhesive and staples groups at either 2 months or 6 months.
","[{'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Cromi', 'Affiliation': 'Department of Obstetrics and Gynecology, ""Filippo Del Ponte"" Hospital, University of Insubria, Varese, Italy.'}, {'ForeName': 'Antonio Simone', 'Initials': 'AS', 'LastName': 'Laganà', 'Affiliation': 'Department of Obstetrics and Gynecology, ""Filippo Del Ponte"" Hospital, University of Insubria, Varese, Italy. Electronic address: antoniosimone.lagana@uninsubria.it.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ghezzi', 'Affiliation': 'Department of Obstetrics and Gynecology, ""Filippo Del Ponte"" Hospital, University of Insubria, Varese, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Valdatta', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Biotechnology and Life Sciences, University of Insubria, Varese, Italy.'}, {'ForeName': 'Jvan', 'Initials': 'J', 'LastName': 'Casarin', 'Affiliation': 'Department of Obstetrics and Gynecology, ""Filippo Del Ponte"" Hospital, University of Insubria, Varese, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cherubino', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Biotechnology and Life Sciences, University of Insubria, Varese, Italy.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2022.02.009']
2172,35182925,Individual patient data meta-analysis of adjuvant gemcitabine-based chemotherapy for biliary tract cancer: combined analysis of the BCAT and PRODIGE-12 studies.,"BACKGROUND


Although gemcitabine-based chemotherapy is the standard of care for advanced biliary tract cancers (BTCs), adjuvant phase III studies (BCAT in Japan, PRODIGE 12 in France) failed to show benefit, possibly owing to fewer patients (n = 225 and n = 194) compared with the adjuvant capecitabine BILCAP trial (n = 447). We performed a combined analysis of both gemcitabine-based chemotherapy adjuvant studies.
METHODS


We performed individual patient data meta-analysis of all patients included in BCAT and PRODIGE 12. BCAT study randomised patients with extrahepatic cholangiocarcinoma to single-agent gemcitabine or observation. PRODIGE 12 randomised patients with all BTC subtypes to gemcitabine-oxaliplatin combination or observation. Combined analysis was performed using Kaplan-Meier curves and a Cox regression model stratified on the trial.
RESULTS


Two hundred and twelve versus 207 patients were randomised in the gemcitabine-based chemotherapy versus observation arms. Baseline characteristics were balanced between arms. The median follow-up was 5.5 years. After 258 relapse-free survival (RFS) events, there was no difference in RFS (log-rank p = 0.45; hazard ratio [HR] = 0.91 [95% confidence interval [CI] 0.71-1.16]; p = 0.46). RFS rates at five years were 40.8% (95%CI: 33.9%-47.5%) for gemcitabine-based chemotherapy versus 36.6% (95%CI: 29.8%-43.4%) for observation. After 201 deaths, there was no difference in overall survival (OS) (log-rank p = 0.83; HR = 1.03 [95%CI: 0.78-1.35]; p = 0.85). OS rates at five years were 50.5% (95%CI: 43.1%-57.4%) for gemcitabine-based chemotherapy versus 49.3% (95%CI: 41.6%-56.5%) for observation.
CONCLUSION


With 419 patients included, this analysis did not show significant improvement in RFS and no trend in improvement in OS. Gemcitabine-based chemotherapy should not be used as an adjuvant treatment for BTC.",2022,"After 201 deaths, there was no difference in overall survival (OS) (log-rank p = 0.83; HR = 1.03","['patients with extrahepatic cholangiocarcinoma to single-agent gemcitabine or observation', 'advanced biliary tract cancers (BTCs), adjuvant phase III studies (BCAT in Japan, PRODIGE 12 in France', '12 randomised patients with all BTC subtypes to', 'Two hundred and twelve versus 207 patients', 'biliary tract cancer']","['capecitabine BILCAP', 'gemcitabine-based chemotherapy', 'gemcitabine-oxaliplatin combination or observation', 'gemcitabine-based chemotherapy adjuvant studies', 'Gemcitabine-based chemotherapy']","['overall survival (OS', 'OS', 'OS rates', 'free survival (RFS) events', 'RFS', 'RFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3805278', 'cui_str': 'Extrahepatic Cholangiocarcinoma'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0053251', 'cui_str': 'Benzotrichloride'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.20212,"After 201 deaths, there was no difference in overall survival (OS) (log-rank p = 0.83; HR = 1.03","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Edeline', 'Affiliation': 'Medical Oncology, Centre Eugène Marquis, av de la bataille Flandres-Dunkerque, 35042 Rennes, France. Electronic address: j.edeline@rennes.unicancer.fr.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hirano', 'Affiliation': 'Department of Gastroenterological Surgery II, Hokkaido University Graduate School of Medicine, Sapporo, Japan. Electronic address: satto@med.hokudai.ac.jp.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Bertaut', 'Affiliation': 'Methodology and Biostatistics Unit, Centre Georges-François Leclerc, Dijon, France. Electronic address: ABertaut@cgfl.fr.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Konishi', 'Affiliation': 'Department of Hepatobiliary-Pancreatic Surgery, National Cancer Centre Hospital East, Kashiwa, Japan. Electronic address: mkonishi@east.ncc.go.jp.'}, {'ForeName': 'Meher', 'Initials': 'M', 'LastName': 'Benabdelghani', 'Affiliation': 'Centre Paul Strauss, Strasbourg, France. Electronic address: mbenabdelghani@strasbourg.unicancer.fr.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Uesaka', 'Affiliation': 'Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Centre Hospital, Shizuoka, Japan. Electronic address: k.uesaka@scchr.jp.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Watelet', 'Affiliation': 'CHU Brabois, Vondoeuvre les Nancy, France. Electronic address: j.watelet@chu-nancy.fr.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohtsuka', 'Affiliation': 'Department of General Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan. Electronic address: otsuka-m@faculty.chiba-u.jp.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'AP-HP hôpital Beaujon, Clichy, France. Electronic address: pascal.hammel@aphp.fr.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Kaneoka', 'Affiliation': 'Department of Surgery, Ogaki Municipal Hospital, Ogaki, Japan. Electronic address: y-kaneoka@omh.ogaki.gifu.jp.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Joly', 'Affiliation': 'CHU Nord, Amiens, France. Electronic address: jean-paul.joly@chu-amiens.fr.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': ""Department of Surgery, Institute of Gastroenterology, TokyoWomen's Medical University, Tokyo, Japan. Electronic address: yamamoto.masakazu@twmu.ac.jp.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Monard', 'Affiliation': 'Unicancer, Paris, France. Electronic address: l-monard@unicancer.fr.'}, {'ForeName': 'Yoshiyasu', 'Initials': 'Y', 'LastName': 'Ambo', 'Affiliation': 'Department of Surgery, Teine-Keijinkai Hospital, Sapporo, Japan. Electronic address: y-ambo.tdr@keijinkai.or.jp.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Louvet', 'Affiliation': 'Institut Mutualiste Montsouris, Paris, France. Electronic address: christophe.louvet@imm.fr.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Centre for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan. Electronic address: mando@med.nagoya-u.ac.jp.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Malka', 'Affiliation': 'Gustave Roussy, Villejuif, France. Electronic address: david.malka@gustaveroussy.fr.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nagino', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Japan. Electronic address: nagino@med.nagoya-u.ac.jp.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Phelip', 'Affiliation': 'CHU St Etienne, St Etienne, France. Electronic address: j.marc.phelip@chu-st-etienne.fr.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Ebata', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Japan. Electronic address: tomoki@med.nagoya-u.ac.jp.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.01.009']
2173,34891224,Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma.,"BACKGROUND


The prognosis of patients with early relapsed or refractory large B-cell lymphoma after the receipt of first-line chemoimmunotherapy is poor.
METHODS


In this international, phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with large B-cell lymphoma that was refractory to or had relapsed no more than 12 months after first-line chemoimmunotherapy to receive axicabtagene ciloleucel (axi-cel, an autologous anti-CD19 chimeric antigen receptor T-cell therapy) or standard care (two or three cycles of investigator-selected, protocol-defined chemoimmunotherapy, followed by high-dose chemotherapy with autologous stem-cell transplantation in patients with a response to the chemoimmunotherapy). The primary end point was event-free survival according to blinded central review. Key secondary end points were response and overall survival. Safety was also assessed.
RESULTS


A total of 180 patients were randomly assigned to receive axi-cel and 179 to receive standard care. The primary end-point analysis of event-free survival showed that axi-cel therapy was superior to standard care. At a median follow-up of 24.9 months, the median event-free survival was 8.3 months in the axi-cel group and 2.0 months in the standard-care group, and the 24-month event-free survival was 41% and 16%, respectively (hazard ratio for event or death, 0.40; 95% confidence interval, 0.31 to 0.51; P<0.001). A response occurred in 83% of the patients in the axi-cel group and in 50% of those in the standard-care group (with a complete response in 65% and 32%, respectively). In an interim analysis, the estimated overall survival at 2 years was 61% in the axi-cel group and 52% in the standard-care group. Adverse events of grade 3 or higher occurred in 91% of the patients who received axi-cel and in 83% of those who received standard care. Among patients who received axi-cel, grade 3 or higher cytokine release syndrome occurred in 6% and grade 3 or higher neurologic events in 21%. No deaths related to cytokine release syndrome or neurologic events occurred.
CONCLUSIONS


Axi-cel therapy led to significant improvements, as compared with standard care, in event-free survival and response, with the expected level of high-grade toxic effects. (Funded by Kite; ZUMA-7 ClinicalTrials.gov number, NCT03391466.).",2022,"At a median follow-up of 24.9 months, the median event-free survival was 8.3 months in the axi-cel group and 2.0 months in the standard-care group, and the 24-month event-free survival was 41% and 16%, respectively (hazard ratio for event or death, 0.40; 95% confidence interval, 0.31 to 0.51; P<0.001).","['patients with large B-cell lymphoma that was refractory to or had relapsed no more than 12 months after first-line', 'A total of 180 patients', 'patients with early relapsed or refractory large B-cell lymphoma after the receipt of first-line']","['chemoimmunotherapy', 'chemoimmunotherapy to receive axicabtagene ciloleucel (axi-cel, an autologous anti-CD19 chimeric antigen receptor T-cell therapy) or standard care (two or three cycles of investigator-selected, protocol-defined chemoimmunotherapy, followed by high-dose chemotherapy with autologous stem-cell transplantation', 'axi-cel and 179 to receive standard care']","['event-free survival', '24-month event-free survival', 'median event-free survival', 'neurologic events', 'overall survival', 'Safety', 'cytokine release syndrome', 'response and overall survival', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C3896829', 'cui_str': 'Axicabtagene ciloleucel'}, {'cui': 'C0208736', 'cui_str': 'N(6)-(1-carboxyethyl)lysine'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C4289797', 'cui_str': 'CAR T-Cell Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C4517609', 'cui_str': '179'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0948245', 'cui_str': 'Cytokine release syndrome'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",180.0,0.317613,"At a median follow-up of 24.9 months, the median event-free survival was 8.3 months in the axi-cel group and 2.0 months in the standard-care group, and the 24-month event-free survival was 41% and 16%, respectively (hazard ratio for event or death, 0.40; 95% confidence interval, 0.31 to 0.51; P<0.001).","[{'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Locke', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Miklos', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Caron A', 'Initials': 'CA', 'LastName': 'Jacobson', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Miguel-Angel', 'Initials': 'MA', 'LastName': 'Perales', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Marie-José', 'Initials': 'MJ', 'LastName': 'Kersten', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Olalekan O', 'Initials': 'OO', 'LastName': 'Oluwole', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Ghobadi', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Aaron P', 'Initials': 'AP', 'LastName': 'Rapoport', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'McGuirk', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Pagel', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Muñoz', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Umar', 'Initials': 'U', 'LastName': 'Farooq', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'van Meerten', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Reagan', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sureda', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vandenberghe', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Song', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dickinson', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Monique C', 'Initials': 'MC', 'LastName': 'Minnema', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Riedell', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Leslie', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Chaganti', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Filosto', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Shah', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Schupp', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'To', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Leo I', 'Initials': 'LI', 'LastName': 'Gordon', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Westin', 'Affiliation': ""From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) - both in California; Dana-Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Vanderbilt-Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) - both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); the Swedish Cancer Institute, Seattle (J.M.P.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J. Muñoz); the University of Iowa, Iowa City (U.F.); Bellvitge Institute for Biomedical Research, Universitat de Barcelona, Hematology Department, Institut Català d'Oncologia-Hospitalet, Barcelona (A.S.); University Hospitals Leuven, Leuven, Belgium (P.V.); the Division of Hematology, University of British Columbia and Leukemia-Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, BC Cancer, Vancouver, Canada (K.W.S.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, VIC, Australia (M.D.); the University of Chicago Medical Center (P.A.R.) and Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University (L.I.G.) - both in Chicago; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); and the University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2116133']
2174,34893381,First-Dose Efficacy of Methylnaltrexone in Patients with Severe Medical Illness and Opioid-Induced Constipation: A Pooled Analysis.,"BACKGROUND


Opioid-induced constipation (OIC) is a frequent consequence of opioid analgesia that may increase patient risk for emergency department visits and hospitalization. Methylnaltrexone is a peripherally acting µ-opioid receptor antagonist indicated for the treatment of OIC.
OBJECTIVE


To assess the safety and efficacy of a single methylnaltrexone dose.
METHODS


Results were pooled from three randomized, placebo-controlled methylnaltrexone (MNTX) studies in opioid-treated patients with advanced illness and OIC, despite treatment with conventional laxatives. Baseline assessments included demographics, disease/treatment characteristics, and functional levels. Efficacy endpoints included rescue-free laxation (RFL) rates within 4 and 24 h, time to first RFL, pain score change, and adverse events (AEs) after a single MNTX dose or placebo.
RESULTS


The analysis included 281 patients receiving MNTX and 237 receiving placebo. Mean age was 66.2 years for MNTX and 65.8 for placebo; ∼50% were men. The most frequent primary diagnosis was cancer (MNTX = 70.5%; placebo = 66.2%) and most (∼98%) were receiving at least one laxative at baseline. RFL occurred in 61.4% vs. 16.0%, and 72.1% vs. 40.1% MNTX vs. placebo patients, within 4 and 24 h of the initial dose, respectively. Relative to placebo, MNTX use reduced the time to first RFL, with most MNTX-treated patients achieving RFL within 2 h. Baseline and posttreatment pain scores were similar (p = 0.9556 vs. placebo for current and worst pain change from baseline), demonstrating that MNTX did not negatively affect opioid analgesia. Most AEs were gastrointestinal related and dissipated by the second dose.
CONCLUSIONS


Methylnaltrexone provides early RFL without compromising analgesia in patients receiving chronic opioid therapy.",2022,"RFL occurred in 61.4% vs. 16.0%, and 72.1% vs. 40.1% MNTX vs. placebo patients, within 4 and 24 h of the initial dose, respectively.","['treated patients with advanced illness and OIC, despite treatment with conventional laxatives', 'Mean age was 66.2 years for MNTX and 65.8 for placebo; ∼50% were men', '281 patients receiving MNTX and 237 receiving', 'patients receiving chronic opioid therapy', 'Patients with Severe Medical Illness and Opioid-Induced Constipation']","['placebo', 'MNTX', 'placebo, MNTX', 'Methylnaltrexone', 'placebo-controlled methylnaltrexone (MNTX', 'opioid']","['posttreatment pain scores', 'time to first RFL', 'safety and efficacy', 'rescue-free laxation (RFL) rates within 4 and 24 h, time to first RFL, pain score change, and adverse events (AEs', 'RFL', 'opioid analgesia', 'demographics, disease/treatment characteristics, and functional levels']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0066411', 'cui_str': 'methylnaltrexone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0066411', 'cui_str': 'methylnaltrexone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C1291733', 'cui_str': 'Posttreatment pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",281.0,0.466761,"RFL occurred in 61.4% vs. 16.0%, and 72.1% vs. 40.1% MNTX vs. placebo patients, within 4 and 24 h of the initial dose, respectively.","[{'ForeName': 'W Frank', 'Initials': 'WF', 'LastName': 'Peacock', 'Affiliation': 'Baylor College of Medicine, Houston, Texas. Electronic address: frankpeacock@gmail.com.'}, {'ForeName': 'Neal E', 'Initials': 'NE', 'LastName': 'Slatkin', 'Affiliation': 'School of Medicine, University of California Riverside, Riverside, California; Salix Pharmaceuticals, Bridgewater, New Jersey.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Israel', 'Affiliation': 'Bausch Health US, LLC, Bridgewater, New Jersey.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Stambler', 'Affiliation': 'Progenics Pharmaceuticals, Inc., a subsidiary of Lantheus Holdings Inc., New York, New York.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2021.10.012']
2175,35180569,Effect of pharmaceutical care program on depression among women with epilepsy: A randomized controlled trial (IPHIWWE study).,"Depression is the most frequent comorbidity of epilepsy, and they are both complex chronic diseases that affect health-related quality of life (HRQOL), especially in women. Pharmaceutical care may contribute significantly to the improvement of HRQOL in women with epilepsy (WWE), with the involvement of the pharmacist in the healthcare team treatments could be optimized and negative outcomes related to medication reduced. This was a randomized controlled trial involving WWE over 18 years of age. The intervention group (IG) received a Pharmaceutical care program consisting of medication review follow-up according to Dáder's method, health education, aids for adherence to treatment, registration of seizures and possible triggers, and therapeutic drug monitoring of anticonvulsants. The control group (CG) received the usual care in the institution. The impact in depression was assessed by changes in the Center for Epidemiologic Studies Depression (CES-D) scale, which was applied both at the first and the last interviews, six months later. One hundred eighty-two WWE entered the study and 144 (79.1%) completed it. At the beginning of the study, 48.95% showed signs of depression, decreasing to 30.43% for the patients in the IG (p-value = 0.0238), while for the patients in the CG it remained at 47.30% (p-value = 0.8693). The Wilcoxon test for comparing the change (Δ) (before-after) in the CES-D scores, between groups, yielded a w = 3138.5, p-value = 0.01802 proving there were statistically significant differences. The study proved that the application of a Pharmaceutical Care program significantly decreases signs of depression in WWE. These results allow us to recommend the implementation of the Pharmaceutical care programs to improve the depression in WWE. Trial registration: Current Controlled Trials ISRCTN46864306 IPHIWWE study.",2022,"The Wilcoxon test for comparing the change (Δ) (before-after) in the CES-D scores, between groups, yielded a w = 3138.5, p-value = 0.01802 proving there were statistically significant differences.","['women with epilepsy', 'women with epilepsy (WWE', '18\u202fyears of age', 'One hundred eighty-two WWE entered the study and 144 (79.1%) completed it']","[""Pharmaceutical care program consisting of medication review follow-up according to Dáder's method, health education, aids for adherence to treatment, registration of seizures and possible triggers, and therapeutic drug monitoring of anticonvulsants"", 'pharmaceutical care program']",['signs of depression'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1449618', 'cui_str': 'Pharmaceutical Care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C1720825', 'cui_str': 'Therapeutic Drug Monitoring'}, {'cui': 'C0003286', 'cui_str': 'Anticonvulsant'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0662324,"The Wilcoxon test for comparing the change (Δ) (before-after) in the CES-D scores, between groups, yielded a w = 3138.5, p-value = 0.01802 proving there were statistically significant differences.","[{'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Losada-Camacho', 'Affiliation': 'Pharmacy Department, Faculty of Sciences, National University of Colombia, Head of Research Group OCAVEC, Colombia. Electronic address: mlosadac@unal.edu.co.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2022.108559']
2176,35180515,A prospective study of switching asthma patients from a Fixed-Dose Combination (FDC) Inhaled Corticosteroid [ICS]/Long-Acting Beta Agonist [LABA] therapy delivered by Dry Powder Inhaler (DPI) to ICS/LABA delivered by pressurised Metered Dose Inhaler (pMDI).,"BACKGROUND


Previous real-world studies have suggested that in comparison to a dry powder inhaler (DPI), the rate of critical errors is lower with a pressurised metered dose inhaler (pMDI), and inhaled corticosteroid/long-acting bronchodilator (ICS/LABA) delivered by pMDI is more likely to achieve asthma control.
OBJECTIVES


To evaluate the acceptability, efficacy, safety and cost-effectiveness of switching asthma patients from an ICS/LABA DPI to an ICS/LABA pMDI in a real-world population in Kuwait.
METHODS


This was a 12-month, observational, nonblinded, prospective, real world study. Patients with asthma for ≥1 year with 2 or more asthma exacerbations in the last year were assigned to either switch to ICS/LABA pMDI, or to continue with ICS/LABA DPI.
RESULTS


A total of 239 patients were treated with either ICS/LABA pMDI (Switch cohort; n = 119) or ICS/LABA DPI (Maintenance cohort; n = 120). The majority of patients (99/119; 83.2%) in the Switch cohort remained on ICS/LABA pMDI over 12 months of follow-up. Both cohorts experienced an improvement in their FEV1 levels, with mean values in the Switch group reaching normal levels (>80% predicted). On average, at 3 and 12 months, the Switch cohort had significantly better FEV1 values than patients in the Maintenance cohort (p = 0.001). At 12 months, the proportion of patients with controlled asthma increased in the Switch group, but did not change significantly in the Maintenance group.
CONCLUSIONS


In patients with asthma symptoms that are not well controlled with an ICS/LABA DPI, switching to an ICS/LABA pMDI provides an alternative choice that may improve asthma control.",2022,"At 12 months, the proportion of patients with controlled asthma increased in the Switch group, but did not change significantly in the Maintenance group.
","['patients with asthma symptoms', 'switching asthma patients', 'Patients with asthma for ≥1 year with 2 or more asthma exacerbations in the last year', '239 patients were treated with either']","['ICS/LABA pMDI', 'ICS/LABA DPI to an ICS/LABA pMDI', 'Fixed-Dose Combination (FDC) Inhaled Corticosteroid [ICS]/Long-Acting Beta Agonist [LABA', 'LABA', 'ICS/LABA DPI', 'corticosteroid/long-acting bronchodilator (ICS/LABA']","['ICS/LABA pMDI', 'acceptability, efficacy, safety and cost-effectiveness', 'FEV1 values', 'FEV1 levels', 'proportion of patients with controlled asthma']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1967611', 'cui_str': 'Dry powder inhaler'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",239.0,0.0933461,"At 12 months, the proportion of patients with controlled asthma increased in the Switch group, but did not change significantly in the Maintenance group.
","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Al-Ahmad', 'Affiliation': 'Microbiology Department, Faculty of Medicine, Kuwait University, Department Allergy, Al-Rashed Allergy Centre, Kuwait. Electronic address: mona.alahmad@ku.edu.kw.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Webb', 'Affiliation': 'Houghton House Group, Johannesburg, South Africa. Electronic address: dawebb@mweb.co.za.'}]",Respiratory medicine,['10.1016/j.rmed.2022.106771']
2177,35180505,"Treatment with RehaCom computerized rehabilitation program improves response control, but not attention in children with attention-deficit/hyperactivity disorder (ADHD).","Attention-deficit/hyperactivity disorder (ADHD) is a common psychiatric disorder in children. ADHD impairs attention, response control, emotion regulation, and other cognitive functions. On the other hand, RehaCom is a cognitive rehabilitation software that has therapeutic effects on cognitive dysfunctions in many diseases such as stroke, multiple sclerosis, and schizophrenia. The goal of the present study was to investigate the effect of treatment with RehaCom on auditory and visual response control, and auditory and visual attention in children with ADHD. Forty patients were selected. The participants were assigned to control (n = 20) and experimental (n = 20) groups, while only the participants in the experimental group were trained by RehaCom for five weeks (ten 45-min sessions, two sessions per week). At weeks 0 and 5, performance of the participants of experimental group was compared with the participants of control group. The results showed that treatment with RehaCom significantly improved auditory and visual response control in children with ADHD, with no effect on auditory and visual attention. In conclusion, RehaCom may alter brain's structural and functional properties that are related to response control. We suggest that attention deficit in ADHD may be a result of more complicated dysfunctions in the brain, that are not affected by RehaCom.",2022,"The results showed that treatment with RehaCom significantly improved auditory and visual response control in children with ADHD, with no effect on auditory and visual attention.","['children with ADHD', 'children with attention-deficit/hyperactivity disorder (ADHD', 'Forty patients were selected']","['RehaCom', 'RehaCom computerized rehabilitation program']","['auditory and visual response control, and auditory and visual attention', 'ADHD impairs attention, response control, emotion regulation, and other cognitive functions', 'auditory and visual response control', 'auditory and visual attention']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",40.0,0.0132046,"The results showed that treatment with RehaCom significantly improved auditory and visual response control in children with ADHD, with no effect on auditory and visual attention.","[{'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Mozaffari', 'Affiliation': 'Department of Psychology, Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Hassani-Abharian', 'Affiliation': 'Department of Rehabilitation, Brain and Cognition Clinic, Tehran, Iran.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Kholghi', 'Affiliation': 'Department of Psychology, Faculty of Human Sciences, Tonekabon Branch, Islamic Azad University, Tonekabon, Iran.'}, {'ForeName': 'Salar', 'Initials': 'S', 'LastName': 'Vaseghi', 'Affiliation': 'Medicinal Plants Research Center, Institute of Medicinal Plants, ACECR, Karaj, Iran.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Zarrindast', 'Affiliation': 'Department of Cognitive Neuroscience, Institute for Cognitive Science Studies (ICSS), Tehran, Iran; Department of Pharmacology School of Medicine, Tehran University of Medical Sciences, Tehran, Iran; Department of Neuroendocrinology, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nasehi', 'Affiliation': 'Cognitive and Neuroscience Research Center (CNRC), Amir-Almomenin Hospital, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran. Electronic address: Nasehi@iricss.org.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2022.02.008']
2178,35181532,"Neurophysiological and behavioral effects of multisession prefrontal tDCS and concurrent cognitive remediation training in patients with autism spectrum disorder (ASD): A double-blind, randomized controlled fNIRS study.","BACKGROUND


The clinical effects and neurophysiological mechanisms of prefrontal tDCS and concurrent cognitive remediation training in individuals with autism spectrum disorder (ASD) remain unclear.
OBJECTIVE


This two-armed, double-blind, randomized, sham-controlled trial aimed to investigate the beneficial effects of tDCS combined with concurrent cognitive remediation training on adolescents and young adults with ASD.
METHODS


Participants were randomly assigned to either active or sham tDCS groups and received 1.5 mA prefrontal tDCS with left dorsolateral prefrontal cortex (dlPFC) cathode placement and right supraorbital region anode placement for 20 minutes over two consecutive weeks. tDCS was delivered concurrently with a computerized cognitive remediation training program. Social functioning and its underlying cognitive processes, as well as prefrontal resting-state functional connectivity (rsFC), were measured.
RESULTS


The results from 41 participants indicated that multisession prefrontal tDCS, compared to sham tDCS, significantly enhanced the social functioning of ASD individuals [F(1,39) = 4.75, p = .035, η p 2  = 0.11]. This improvement was associated with enhanced emotion recognition [F(1,39) = 8.34, p = .006, η p 2  = 0.18] and cognitive flexibility [F(1,39) = 4.91, p = .033, η p 2  = 0.11]. Specifically, this tDCS protocol optimized information processing efficiency [F(1,39) = 4.43, p = .042, η p 2  = 0.10], and the optimization showed a trend to be associated with enhanced rsFC in the right medial prefrontal cortex (ρ = 0.339, pFDR = .083).
CONCLUSION


Multisession tDCS with left dlPFC cathode placement and right supraorbital region anode placement paired with concurrent cognitive remediation training promoted social functioning in individuals with ASD. This appeared to be associated with the enhancement of the functional connectivity of the right medial PFC, a major hub for flexible social information processing, allowing these individuals to process information more efficiently in response to different social situations.
TRIAL REGISTRATION


ClinicalTrials.gov (ID: NCT03814083).",2022,"Specifically, this tDCS protocol optimized information processing efficiency","['individuals with ASD', 'individuals with autism spectrum disorder (ASD', 'Participants', 'patients with autism spectrum disorder (ASD', 'adolescents and young adults with ASD']","['multisession prefrontal tDCS and concurrent cognitive remediation training', 'prefrontal tDCS and concurrent cognitive remediation training', 'tDCS combined with concurrent cognitive remediation training', 'cognitive remediation training', 'active or sham tDCS groups and received 1.5\u202fmA prefrontal tDCS with left dorsolateral prefrontal cortex cathode placement and right supraorbital region anode placement', 'tDCS']","['multisession prefrontal tDCS', 'cognitive flexibility', 'prefrontal resting-state functional connectivity (rsFC', 'social functioning', 'enhanced emotion recognition']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0007441', 'cui_str': 'Cathode'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0003103', 'cui_str': 'Anode'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",41.0,0.104466,"Specifically, this tDCS protocol optimized information processing efficiency","[{'ForeName': 'Yvonne M Y', 'Initials': 'YMY', 'LastName': 'Han', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China; University Research Facility in Behavioral and Systems Neuroscience (UBSN), The Hong Kong Polytechnic University, Hong Kong SAR, China. Electronic address: yvonne.han@polyu.edu.hk.'}, {'ForeName': 'Melody M Y', 'Initials': 'MMY', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Caroline K S', 'Initials': 'CKS', 'LastName': 'Shea', 'Affiliation': 'Alice Ho Miu Ling Nethersole Hospital, Hospital Authority, Hong Kong SAR, China; Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Oscar Long-Hin', 'Initials': 'OL', 'LastName': 'Lai', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Karthikeyan', 'Initials': 'K', 'LastName': 'Krishnamurthy', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Mei-Chun', 'Initials': 'MC', 'LastName': 'Cheung', 'Affiliation': 'Department of Social Work, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Agnes S', 'Initials': 'AS', 'LastName': 'Chan', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Hong Kong SAR, China.'}]",Brain stimulation,['10.1016/j.brs.2022.02.004']
2179,35181530,Effect of maternal body mass index on the prophylactic dose of phenylephrine for preventing hypotension in parturients after spinal anaesthesia.,"BACKGROUND


To compare the median effective dose (ED 50 ) of phenylephrine for prophylactic continuous infusion in parturients with different body mass indices (BMIs) during combined spinal-epidural anaesthesia for caesarean section and to investigate the impact of maternal BMI on the prophylactic dose of phenylephrine.
METHODS


Parturients receiving combined spinal-epidural anaesthesia for elective caesarean section were divided into a standard group (Group S, BMI < 30 kg/m 2 ) and an obesity group (Group O, BMI > 30 kg/m 2 ), each with 30 patients. A sequential allocation design was used to administer the prophylactic infusion of phenylephrine after the completion of a spinal anaesthetic injection to prevent hypotension (defined as a reduction of systolic blood pressure ≥ 20% of the baseline value or systolic blood pressure < 90 mmHg), with an initial infusion rate of 50 μg/min for the first parturient subsequent adjusted up or down by 10 μg/min depending on whether the previous parturient developed hypotension or not during the study period. The Dixon and Massey method and the isotonic regression method were used to calculate and compare the ED 50  and 95% confidence interval (CI) of phenylephrine between the two groups.
RESULTS


The results were 21.92 μg/min (95% CI, 14.90-28.94 μg/min) for Group S and 42.14 μg/min (95% CI, 24.58-59.70 μg/min) for Group O. The ratio of relative potency of Group O to Group S is 1.92 (95% CI 1.09-3.14), P = 0.034.
CONCLUSIONS


The dose of phenylephrine for the prevention of hypotension after spinal anaesthesia for caesarean section is dependent on maternal BMI. Therefore, a weight-based phenylephrine dose is reasonable.",2022,The dose of phenylephrine for the prevention of hypotension after spinal anaesthesia for caesarean section is dependent on maternal BMI.,"['Parturients receiving combined spinal-epidural anaesthesia for elective caesarean section', 'parturients with different body mass indices (BMIs) during combined spinal-epidural anaesthesia for caesarean section', 'parturients after spinal anaesthesia']",['phenylephrine'],['ratio of relative potency'],"[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0660302,The dose of phenylephrine for the prevention of hypotension after spinal anaesthesia for caesarean section is dependent on maternal BMI.,"[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Anaesthesia, Obstetrics & Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qiuyu', 'Initials': 'Q', 'LastName': 'Meng', 'Affiliation': 'Department of Anaesthesia, Obstetrics & Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Anaesthesia, Obstetrics & Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shaoqiang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Anaesthesia, Obstetrics & Gynaecology Hospital, Fudan University, Shanghai, China. Electronic address: drhuangsq@163.com.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Division of Epidemiology, Biostatistics, and Environmental Health, School of Public Health, University of Memphis, Memphis, TN, USA.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2022.101035']
2180,35181515,Can intraoperative radiation dose in percutaneous posterior thoracolumbar internal fixation be reduced by impedancemetry-guided pedicle sighting? A prospective randomized study.,"INTRODUCTION


Percutaneous spine surgery is on the rise; the main drawback is iterative irradiation of the care team in theater. The aim of the present study was to compare intraoperative radiation dose in percutaneous posterior thoracolumbar internal fixation (PPTLIF) using impedancemetry-guided pedicle sighting by the PediGuard device (SpineGuard®) versus gold-standard free-hand sighting.
MATERIAL AND METHODS


A single-center, single-surgeon continuous prospective randomized study was conducted from September 2017 to April 2018. Dose-area product (DAP, in cGy.cm 2 ) was recorded at the end of pedicle sighting and end of surgery in the free-hand control group and the impedancemetry group. Pedicle screw position was studied on postoperative CT scan.
RESULTS


Sixteen patients were included in either group after 2 had been excluded. The groups were comparable for age, gender, body-mass index (BMI), indication and number of instrumented levels. Mean DPA at end of sighting and end of procedure was respectively 147.4 cGy.cm 2  and 230.9 cGy.cm 2  in the control group and 171.1 cGy.cm 2  and 280.7 cGy.cm 2  in the PediGuard group (p> 0.05). Screw positioning on CT was comparable in the 2 groups.
CONCLUSION


In the present study, the PediGuard device did not reduce intraoperative radiation dose. The correlation between radiation dose and BMI was confirmed.
LEVEL OF EVIDENCE


II; prospective randomized study.",2022,"Screw positioning on CT was comparable in the 2 groups.
","['September 2017 to April 2018', 'Sixteen patients were included in either group after 2 had been excluded']","['Percutaneous spine surgery', 'percutaneous posterior thoracolumbar internal fixation (PPTLIF) using impedancemetry-guided pedicle sighting by the PediGuard device (SpineGuard®) versus gold-standard free-hand sighting', 'Pedicle screw position']",['Mean DPA'],"[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0456605', 'cui_str': 'Pedicle'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}]",16.0,0.0167085,"Screw positioning on CT was comparable in the 2 groups.
","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lebhar', 'Affiliation': 'ILO Rachis/CHP Saint-Grégoire, Orthopedics and Trauma, 7, boulevard de la Boutière, 35760 Saint-Grégoire, France. Electronic address: dr.lebhar@gmail.com.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Bryand', 'Affiliation': 'Orthopedics, Trauma Department, Pontchaillou University Hospital, 2, rue Henri-le-Guilloux, 35000 Rennes, France.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Breton', 'Affiliation': 'Orthopedics, Trauma Department, Pontchaillou University Hospital, 2, rue Henri-le-Guilloux, 35000 Rennes, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Bourgouin', 'Affiliation': 'Orthopedics, Trauma Department, Pontchaillou University Hospital, 2, rue Henri-le-Guilloux, 35000 Rennes, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Chatellier', 'Affiliation': 'Orthopedics, Trauma Department, Pontchaillou University Hospital, 2, rue Henri-le-Guilloux, 35000 Rennes, France.'}, {'ForeName': 'Mickaël', 'Initials': 'M', 'LastName': 'Ropars', 'Affiliation': 'Orthopedics, Trauma Department, Pontchaillou University Hospital, 2, rue Henri-le-Guilloux, 35000 Rennes, France.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2022.103250']
2181,34872064,Cognitive Outcomes at 18 Months: Findings from the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial.,"Micronutrient deficiencies and enteric infections negatively impact child growth and development. We enrolled children shortly after birth in a randomized, placebo-controlled, 2 × 2 factorial interventional trial in Haydom, Tanzania, to assess nicotinamide and/or antimicrobials (azithromycin and nitazoxanide) effect on length at 18 months of age. Cognitive score at 18 months using the Malawi Developmental Assessment Tool (MDAT), which includes gross motor, fine motor, language, and social assessments, was a secondary outcome. Here, we present the MDAT results of 1,032 children. There was no effect of nicotinamide (change in development-for-age Z score [DAZ] -0.08; 95% CI: -0.16, 0) or antimicrobials (change in DAZ 0.04; 95% CI: -0.06, 0.13) on overall MDAT score. The interventions had no effect on cognitive outcomes in subgroups defined by gender, socioeconomic status, birthweight, and birth season or on MDAT subscores. Further analyses are needed to identify targetable risk factors for impaired cognitive development in these settings.",2021,"The interventions had no effect on cognitive outcomes in subgroups defined by gender, socioeconomic status, birthweight, and birth season or on MDAT subscores.","['1,032 children']","['placebo', 'nicotinamide and/or antimicrobials (azithromycin and nitazoxanide', 'Malawi Developmental Assessment Tool (MDAT']","['overall MDAT score', 'cognitive outcomes', 'Cognitive score', 'socioeconomic status, birthweight, and birth season or on MDAT subscores']","[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0068788', 'cui_str': 'nitazoxanide'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]",1032.0,0.339376,"The interventions had no effect on cognitive outcomes in subgroups defined by gender, socioeconomic status, birthweight, and birth season or on MDAT subscores.","[{'ForeName': 'Tarina', 'Initials': 'T', 'LastName': 'Parpia', 'Affiliation': 'University of Virginia Division of Infectious Diseases and International Health, Charlottesville, Virginia.'}, {'ForeName': 'Erling', 'Initials': 'E', 'LastName': 'Svensen', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Elwood', 'Affiliation': 'University of Virginia Division of Infectious Diseases and International Health, Charlottesville, Virginia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wanjuhi', 'Affiliation': 'University of Virginia Division of Infectious Diseases and International Health, Charlottesville, Virginia.'}, {'ForeName': 'Ladislaus', 'Initials': 'L', 'LastName': 'Blacy', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'Eliwaza', 'Initials': 'E', 'LastName': 'Bayo', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Houpt', 'Affiliation': 'University of Virginia Division of Infectious Diseases and International Health, Charlottesville, Virginia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rogawski McQuade', 'Affiliation': 'University of Virginia Division of Infectious Diseases and International Health, Charlottesville, Virginia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'DeBoer', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Platts-Mills', 'Affiliation': 'University of Virginia Division of Infectious Diseases and International Health, Charlottesville, Virginia.'}, {'ForeName': 'Estomih', 'Initials': 'E', 'LastName': 'Mduma', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Scharf', 'Affiliation': 'University of Virginia Division of Infectious Diseases and International Health, Charlottesville, Virginia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.21-0596']
2182,35184004,Acute alcohol rewarding effects as a risk factor for hangover frequency.,"BACKGROUND/PURPOSE


Acute subjective alcohol effects appear to play an important role in predicting alcohol hangover. However, no studies have used a laboratory-based alcohol challenge to examine the concurrent or longitudinal effects of subjective alcohol responses on hangover frequency. As such, we investigated the direct and indirect effects of alcohol stimulation, sedation, liking and wanting, as measured in a controlled setting, on hangover frequency over five years.
METHOD


Participants were 294 young adult light-to-heavy social drinkers (aged 21-35 years, 42% female) enrolled in the Chicago Social Drinking Project. The study utilized a placebo-controlled, double blind, laboratory alcohol challenge and a battery of measures including the Biphasic Alcohol Effects Scale, Drug Effects Questionnaire, Hangover Symptom Scale, and alcohol use Quantity-Frequency Interview, with the latter two re-administered after five years.
RESULTS


Through the use of a path analysis, the present study found significant direct effects from alcohol liking to hangover frequency at initial testing. In addition, there were multiple significant indirect effects from greater alcohol liking and wanting to greater alcohol use quantity-frequency and, in turn, greater hangover frequency at initial testing and 5-year follow-up. Last, there were significant indirect effects from greater alcohol sedation to less alcohol use quantity-frequency and, in turn, less hangover frequency at initial testing and 5-year follow-up.
CONCLUSION


This study highlights the role of the hedonic reward and motivational salience of alcohol as potential mechanisms of alcohol-related consequences (i.e., hangover) among light-to-heavy social drinking young adults.",2022,"Through the use of a path analysis, the present study found significant direct effects from alcohol liking to hangover frequency at initial testing.","['heavy social drinking young adults', 'Participants were 294 young adult light-to-heavy social drinkers (aged 21-35\xa0years, 42% female) enrolled in the Chicago Social Drinking Project']",['placebo'],"['Biphasic Alcohol Effects Scale, Drug Effects Questionnaire, Hangover Symptom Scale, and alcohol use Quantity-Frequency Interview']","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337676', 'cui_str': 'Social drinker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0221100', 'cui_str': 'Hangover'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]",294.0,0.00460301,"Through the use of a path analysis, the present study found significant direct effects from alcohol liking to hangover frequency at initial testing.","[{'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Chavarria', 'Affiliation': 'Centre for Addiction and Mental Health, 100 Collip Cir. Suite 200, London, ON N6G 4X8, Canada. Electronic address: jesus.chavarria@camh.ca.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Fridberg', 'Affiliation': 'Department of Psychiatry & Behavioral Neuroscience, University of Chicago, 5841 S. Maryland Avenue MC-3077, Chicago, IL 60637, United States.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry & Behavioral Neuroscience, University of Chicago, 5841 S. Maryland Avenue MC-3077, Chicago, IL 60637, United States. Electronic address: aking@bsd.uchicago.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2022.107279']
2183,35184003,A community-based tobacco cessation program for individuals experiencing homelessness.,"BACKGROUND


Tobacco use is common among persons experiencing homelessness (PEH), and interventions are needed. We conducted a community-based, single-arm uncontrolled trial of a pharmacy-linked intervention for smoking cessation for PEH.
METHODS


The intervention took place between September 2019 and June 2021 in homeless shelters in San Francisco, CA. We trained shelter staff on how to provide brief cessation counseling, then tested a program among PEH in two shelters that included one-time pharmacist-delivered cessation counseling and nicotine replacement therapy (NRT) for 3 months. We examined factors associated with cigarette consumption and quit attempts.
RESULTS


We trained 69 staff from 8 shelters and selected 2 of those shelters as pilot sites for the program. Of the 52 participants, 71% were male and 49% were Black. The majority of participants reported making a quit attempt (70%) and using NRT (84%). Having an encounter with staff in the past week was associated with a 40% reduction in weekly consumption (Incidence rate ratio (IRR) 0.61, 95% CI 0.57-0.67) and using medications in the past week was associated with a 23% reduction in weekly consumption (IRR 0.78, 95% CI 0.75-0.81). Using medications in the past week increased the odds of a quit attempt 2.89 times compared to not using medications (Adjusted odds ratio (AOR), 2.89, 95% CI 1.45-5.77).
CONCLUSIONS


Our findings highlight a role for leveraging community-based pharmacists to expand smoking cessation services in homeless shelters to reduce tobacco use among PEH.",2022,"Using medications in the past week increased the odds of a quit attempt 2.89 times compared to not using medications (Adjusted odds ratio (AOR), 2.89, 95% CI 1.45-5.77).
","['individuals experiencing homelessness', 'September 2019 and June 2021 in homeless shelters in San Francisco, CA', 'persons experiencing homelessness (PEH', 'homeless shelters', '52 participants, 71% were male and 49% were Black']","['community-based tobacco cessation program', 'cessation counseling and nicotine replacement therapy (NRT', 'pharmacy-linked intervention']",['weekly consumption (Incidence rate ratio (IRR'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0083017', 'cui_str': 'insulin receptor-related receptor'}]",71.0,0.0689387,"Using medications in the past week increased the odds of a quit attempt 2.89 times compared to not using medications (Adjusted odds ratio (AOR), 2.89, 95% CI 1.45-5.77).
","[{'ForeName': 'Marlena', 'Initials': 'M', 'LastName': 'Hartman-Filson', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco, CA, USA. Electronic address: maya.vijayaraghavan@ucsf.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Pharmacy, Fontana Treatment Center, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Priscella', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'San Francisco Health Plan, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Phan', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Dorie E', 'Initials': 'DE', 'LastName': 'Apollonio', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kroon', 'Affiliation': 'School of Pharmacy, Fontana Treatment Center, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Donald', 'Affiliation': 'San Francisco Health Plan, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Vijayaraghavan', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco, CA, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2022.107282']
2184,35183991,Patient-reported health-related quality of life from a randomized phase II trial comparing standard-dose with high-dose twice daily thoracic radiotherapy in limited stage small-cell lung cancer.,"OBJECTIVES


In a randomized phase II trial, twice daily (BID) thoracic radiotherapy (TRT) of 60 Gy/40 fractions improved survival compared with 45 Gy/30 fractions in limited stage small-cell lung cancer (LS SCLC). Notably, the higher dose did not cause more toxicity. Here we present health related quality of life (HRQoL) reported by the trial participants during the first 2 years.
MATERIALS AND METHODS


170 patients were randomized 1:1 to TRT of 45 Gy or 60 Gy concurrently with cisplatin/etoposide chemotherapy. The 150 patients who commenced TRT and completed a minimum of one HRQoL-questionnaire were included in the present study. Patients reported HRQoL on the European Organization for Research and Treatment of Cancer Core 30 and Lung Cancer 13 Quality of Life Questionnaires. Questionnaires were completed weeks 0, 4 (before TRT), 8 (end of TRT), 12 (response evaluation after chemoradiotherapy) and 16 (end of prophylactic cranial irradiation), then every 10 weeks year one, and every 3 months year two. Primary HRQoL endpoints were dysphagia and dyspnea. A difference in mean score of ≥10 was defined as clinically significant.
RESULTS


Maximum dysphagia was reported on week 8, with no significant difference between treatment arms (mean scores 45 Gy: 44.2, 60 Gy: 51.1). The 60 Gy arm had more dysphagia in the convalescence period, but dysphagia scores returned to baseline levels at week 16 in both arms. For dyspnea there were no significant changes, or differences between treatment arms, at any timepoint. There were no significant differences between treatment arms for any other HRQoL-scales.
CONCLUSION


TRT of 60 Gy did not cause significantly higher maximum dysphagia, though patients on the 60 Gy arm reported more dysphagia the first 8 weeks of convalescence. The higher dose was well tolerated and is an attractive alternative to current TRT schedules in LS SCLC. Trial reg Clinicaltrials.gov NCT0204184.",2022,"TRT of 60 Gy did not cause significantly higher maximum dysphagia, though patients on the 60 Gy arm reported more dysphagia the first 8 weeks of convalescence.","['170 patients', 'limited stage small-cell lung cancer', 'Cancer Core 30 and Lung Cancer 13', '150 patients who commenced TRT and completed a minimum of one HRQoL-questionnaire were included in the present study']","['thoracic radiotherapy', 'twice daily (BID) thoracic', 'TRT of 45\xa0Gy or 60\xa0Gy concurrently with cisplatin/etoposide chemotherapy', 'radiotherapy (TRT']","['survival', 'dysphagia and dyspnea', 'dysphagia scores', 'maximum dysphagia', 'Quality of Life Questionnaires', 'dysphagia', 'Maximum dysphagia', 'toxicity', 'health related quality of life (HRQoL']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278725', 'cui_str': 'Small cell lung cancer limited stage'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4505266', 'cui_str': 'One Health Concept'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0078414', 'cui_str': 'VP-P protocol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",170.0,0.218152,"TRT of 60 Gy did not cause significantly higher maximum dysphagia, though patients on the 60 Gy arm reported more dysphagia the first 8 weeks of convalescence.","[{'ForeName': 'Kristin Toftaker', 'Initials': 'KT', 'LastName': 'Killingberg', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Department of Oncology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway. Electronic address: Kristin.T.Killingberg@ntnu.no.'}, {'ForeName': 'Tarje Onsøien', 'Initials': 'TO', 'LastName': 'Halvorsen', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Department of Oncology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Fløtten', 'Affiliation': 'Department of Thoracic Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Odd Terje', 'Initials': 'OT', 'LastName': 'Brustugun', 'Affiliation': 'Section of Oncology, Drammen Hospital, Vestre Viken Health Trust, Drammen, Norway.'}, {'ForeName': 'Seppo W', 'Initials': 'SW', 'LastName': 'Langer', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Nyman', 'Affiliation': 'Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Hornslien', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Tesfaye', 'Initials': 'T', 'LastName': 'Madebo', 'Affiliation': 'Department of Pulmonary Medicine, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Schytte', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Risum', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Denmark.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tsakonas', 'Affiliation': 'Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Engleson', 'Affiliation': 'Department of Oncology, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Bjørn Henning', 'Initials': 'BH', 'LastName': 'Grønberg', 'Affiliation': 'Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Department of Oncology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2022.02.002']
2185,35183923,Feasibility and initial efficacy of a multimodal swelling intervention after total knee arthroplasty: A prospective pilot study with historical controls.,"BACKGROUND


Swelling after total knee arthroplasty (TKA) is often profound and persistent, increasing risks of DVT, infection, and wound dehiscence, and impairing rehabilitation. We investigated the feasibility and initial efficacy of a multimodal swelling control intervention (MSI), comprised of an inelastic adjustable compression garment (CG), manual lymph drainage (MLD) massage, and home exercise program (HEP) after total knee arthroplasty (TKA) compared to a control group.
METHODS


Sixteen individuals (mean age 64.7 ± 7.1y) performed MSI for three weeks after TKA, through day 21 (D21). Outcome measures included patient satisfaction, safety, patient adherence, and swelling measured by Single Frequency Bioimpedance Assessment (SF-BIA). All outcomes were measured preoperatively and at postoperative D4, D7, D14, D21 and, three weeks after discontinuing MSI, on D42. Efficacy of MSI was calculated with Hedge's g effect size estimates using the SF-BIA ratios for MSI versus CONTROL (N = 56; mean age 64.3 ± 9.3y) at key post operative time points.
RESULTS


Patient satisfaction was 93% with no adverse events. Adherence to CG, MLD, and HEP were 85%, 99%, and 97% respectively. Peak swelling reduction with MSI was at D21 (Hedges' g = 1.60 at D21 (95% CI 0.99, 2.21)). Minimal change in swelling was observed three weeks after cessation of MSI on D42.
CONCLUSIONS


The self-administered MSI program is feasible and demonstrated strong initial efficacy to control swelling after TKA. Minimal rebound swelling was observed once MSI was withdrawn at D21. Future studies should examine the efficacy of inelastic adjustable compression in a randomized controlled trial.",2022,"Outcome measures included patient satisfaction, safety, patient adherence, and swelling measured by Single Frequency Bioimpedance Assessment (SF-BIA).","['Sixteen individuals (mean age 64.7\xa0±\xa07.1y) performed', 'Swelling after total knee arthroplasty (TKA', 'total knee arthroplasty']","['inelastic adjustable compression garment (CG), manual lymph drainage (MLD) massage, and home exercise program (HEP) after total knee arthroplasty (TKA', 'multimodal swelling intervention', 'multimodal swelling control intervention (MSI', 'MSI']","['Minimal rebound swelling', 'patient satisfaction, safety, patient adherence, and swelling measured by Single Frequency Bioimpedance Assessment (SF-BIA', 'feasibility and initial efficacy', 'Minimal change in swelling', 'Peak swelling reduction with MSI', 'SF-BIA ratios', 'Feasibility and initial efficacy', 'Adherence to CG, MLD, and HEP']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C2985539', 'cui_str': 'Compression garment'}, {'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}, {'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]",,0.0947922,"Outcome measures included patient satisfaction, safety, patient adherence, and swelling measured by Single Frequency Bioimpedance Assessment (SF-BIA).","[{'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Carmichael', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, University of Colorado Anschutz Medical Campus, 13121 E 17(th) Ave, Mail Stop C244, Aurora, CO 80045, USA. Electronic address: Joel.carmichael@cuanschutz.edu.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Dennis', 'Affiliation': 'Colorado Joint Replacement, 2535 Downing Street, Unit 100, Denver, CO 80210, USA. Electronic address: Douglas.dennis@centura.org.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Jennings', 'Affiliation': 'Colorado Joint Replacement, 2535 Downing Street, Unit 100, Denver, CO 80210, USA; Department of Mechanical and Materials Engineering, University of Denver, 2199 S. University Blvd., Denver, CO 80218, USA. Electronic address: Jason.jennings@centura.org.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stevens-Lapsley', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, University of Colorado Anschutz Medical Campus, 13121 E 17(th) Ave, Mail Stop C244, Aurora, CO 80045, USA; Geriatric Research Education and Clinical Center, Rocky Mountain Regional VA Medical Center, 1700 Wheeling Street, Aurora, CO 80045, USA. Electronic address: Jennifer.stevens-lapsley@cuanschutz.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bade', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, University of Colorado Anschutz Medical Campus, 13121 E 17(th) Ave, Mail Stop C244, Aurora, CO 80045, USA; Geriatric Research Education and Clinical Center, Rocky Mountain Regional VA Medical Center, 1700 Wheeling Street, Aurora, CO 80045, USA. Electronic address: Michael.bade@cuanschutz.edu.'}]",The Knee,['10.1016/j.knee.2022.01.008']
2186,34420980,A Combined Prospective and Retrospective Comparison of Long-Term Functional Outcomes Suggests Delayed Loss of Ambulation and Pulmonary Decline with Long-Term Eteplirsen Treatment.,"BACKGROUND


Studies 4658-201/202 (201/202) evaluated treatment effects of eteplirsen over 4 years in patients with Duchenne muscular dystrophy and confirmed exon-51 amenable genetic mutations. Chart review Study 4658-405 (405) further followed these patients while receiving eteplirsen during usual clinical care.
OBJECTIVE


To compare long-term clinical outcomes of eteplirsen-treated patients from Studies 201/202/405 with those of external controls.
METHODS


Median total follow-up time was approximately 6 years of eteplirsen treatment. Outcomes included loss of ambulation (LOA) and percent-predicted forced vital capacity (FVC%p). Time to LOA was compared between eteplirsen-treated patients and standard of care (SOC) external controls and was measured from eteplirsen initiation in 201/202 or, in the SOC group, from the first study visit. Comparisons were conducted using univariate Kaplan-Meier analyses and log-rank tests, and multivariate Cox proportional hazards models with regression adjustment for baseline characteristics. Annual change in FVC%p was compared between eteplirsen-treated patients and natural history study patients using linear mixed models with repeated measures.
RESULTS


Data were included from all 12 patients in Studies 201/202 and the 10 patients with available data from 405. Median age at LOA was 15.16 years. Eteplirsen-treated patients experienced a statistically significant longer median time to LOA by 2.09 years (5.09 vs. 3.00 years, p < 0.01) and significantly attenuated rates of pulmonary decline vs. natural history patients (FVC%p change: -3.3 vs. -6.0 percentage points annually, p < 0.0001).
CONCLUSIONS


Study 405 highlights the functional benefits of eteplirsen on ambulatory and pulmonary function outcomes up to 7 years of follow-up in comparison to external controls.",2022,"Eteplirsen-treated patients experienced a statistically significant longer median time to LOA by 2.09 years (5.09 vs. 3.00 years, p < 0.01) and significantly attenuated rates of pulmonary decline vs. natural history patients (FVC%p change: -3.3 vs. -6.0 percentage points annually, p < 0.0001).
","['Median total follow-up time was approximately 6 years of eteplirsen treatment', 'patients with Duchenne muscular dystrophy and confirmed', '4658-405 (405) further followed these patients while receiving eteplirsen during usual clinical care', 'Data were included from all 12 patients in Studies 201/202 and the 10 patients with available data from 405', 'eteplirsen-treated patients from Studies 201/202/405 with those of external controls']",[],"['Annual change in FVC%p', 'rates of pulmonary decline', 'loss of ambulation (LOA) and percent-predicted forced vital capacity (FVC%p', 'Time to LOA', 'median time to LOA']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4283710', 'cui_str': 'eteplirsen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",4658.0,0.0306098,"Eteplirsen-treated patients experienced a statistically significant longer median time to LOA by 2.09 years (5.09 vs. 3.00 years, p < 0.01) and significantly attenuated rates of pulmonary decline vs. natural history patients (FVC%p change: -3.3 vs. -6.0 percentage points annually, p < 0.0001).
","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Mitelman', 'Affiliation': 'Sarepta Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Hoda Z', 'Initials': 'HZ', 'LastName': 'Abdel-Hamid', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Barry J', 'Initials': 'BJ', 'LastName': 'Byrne', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Connolly', 'Affiliation': ""Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USA.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Heydemann', 'Affiliation': 'Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Proud', 'Affiliation': ""Children's Hospital of The King's Daughters, Norfolk, VA, USA.""}, {'ForeName': 'Perry B', 'Initials': 'PB', 'LastName': 'Shieh', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Kathryn R', 'Initials': 'KR', 'LastName': 'Wagner', 'Affiliation': 'Kennedy Krieger Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Dugar', 'Affiliation': 'Sarepta Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Sourav', 'Initials': 'S', 'LastName': 'Santra', 'Affiliation': 'Sarepta Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Signorovitch', 'Affiliation': 'Analysis Group, Inc., Boston, MA, USA.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Goemans', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'McDonald', 'Affiliation': 'University of California Davis Health System, Sacramento, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Mercuri', 'Affiliation': 'Catholic University, Rome, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Jerry R', 'Initials': 'JR', 'LastName': 'Mendell', 'Affiliation': ""Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USA.""}]",Journal of neuromuscular diseases,['10.3233/JND-210665']
2187,35180667,Retromolar intubation with video intubating stylet in difficult airway: A randomized crossover manikin study.,"OBJECTIVE


Difficult airway situations, such as trismus and neck rigidity, may prohibit standard midline orotracheal intubation. An alternative route of intubation from the retromolar space using a fiberoptic scope or rigid intubation stylet has been reported. There is no study investigating the applicability of retromolar intubation using a video intubating stylet. This study comparatively analyzed difficult airway management using a video intubating stylet in the retromolar and standard midline approaches.
METHODS


A randomized crossover manikin study was conducted between January 2021 and June 2021 at a tertiary teaching hospital. Thirty-six emergency medicine residents and attending physicians were enrolled, and all participated in an educational course regarding video intubating stylet in standard midline and retromolar approaches. Then, they performed both intubation approaches in a randomized order on a manikin seven times with different airway settings each time. The duration of successful intubation, first attempt success rate, overall success rate, number of attempts, and self-reported difficulty were recorded and compared.
RESULTS


Thirty-six emergency physicians were included in the study. Compared with the standard midline approach, the use of the retromolar approach significantly reduced the duration of successful intubation in difficult airway scenarios such as limited mouth opening and neck rigidity with (44.77 [28.58-63.65] vs. 120 [93.86-120] s, p < 0.001) and without tongue edema (31.5 [22.57-57.74] vs. 44.72 [36.23-65.34] s, p = 0.012). Furthermore, the retromolar approach increased the first attempt success rate in scenarios of limited mouth opening and neck rigidity with (91.67% vs. 16.67%, p < 0.001) and without (97.22% vs. 72.22%, p = 0.012) tongue edema. The self-reported difficulty was also significantly lower with the retromolar approach than with the standard approach in the above two scenarios.
CONCLUSIONS


The retromolar approach for intubation using a video intubating stylet may be a promising choice for selected patients with a combination of difficult airway features such as limited mouth opening, neck rigidity, and edematous tongue.",2022,"The self-reported difficulty was also significantly lower with the retromolar approach than with the standard approach in the above two scenarios.
","['Thirty-six emergency physicians were included in the study', 'difficult airway', 'January 2021 and June 2021 at a tertiary teaching hospital', 'Thirty-six emergency medicine residents and attending physicians were enrolled, and all participated in an']","['educational course regarding video intubating stylet in standard midline and retromolar approaches', 'retromolar intubation', 'Retromolar intubation with video intubating stylet']","['duration of successful intubation, first attempt success rate, overall success rate, number of attempts, and self-reported difficulty', 'tongue edema', 'duration of successful intubation']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1320929', 'cui_str': 'Attending physician'}]","[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0151610', 'cui_str': 'Edema of the tongue'}]",,0.0296763,"The self-reported difficulty was also significantly lower with the retromolar approach than with the standard approach in the above two scenarios.
","[{'ForeName': 'Yen-Yu', 'Initials': 'YY', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency Medicine, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chiayi City 600, Taiwan.'}, {'ForeName': 'Jih-Chun', 'Initials': 'JC', 'LastName': 'Lin', 'Affiliation': 'Department of Emergency Medicine, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chiayi City 600, Taiwan.'}, {'ForeName': 'Ming-Jen', 'Initials': 'MJ', 'LastName': 'Tsai', 'Affiliation': 'Department of Emergency Medicine, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chiayi City 600, Taiwan. Electronic address: tshi33@gmail.com.'}, {'ForeName': 'Kai-Yuan', 'Initials': 'KY', 'LastName': 'Cheng', 'Affiliation': 'Department of Emergency Medicine, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chiayi City 600, Taiwan. Electronic address: cimbatw@gmail.com.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2022.02.008']
2188,35181470,MRI-based radiomics models can improve prognosis prediction for nasopharyngeal carcinoma with neoadjuvant chemotherapy.,"BACKGROUND


The purpose of this study was to explore the prognostic value of imaging features and related models in nasopharyngeal carcinoma (NPC) patients that received neoadjuvant chemotherapy.
MATERIALS AND METHODS


We systematically reviewed the data of 110 NPC patients who received radiotherapy and neoadjuvant chemotherapy. The patients were randomly divided into the training cohort (n = 88) and the verification cohort (n = 22). The imaging data collected in this study were screened via Pyramidics and used to construct prediction models based on histology and clinical nomographs. The models' accuracy was evaluated via calibration curves and the consistency index (C-index). In addition, we also explored the correlation between radiomics expression patterns, quantitative histological characteristics, and clinical data and then constructed a model to predict the prognosis of NPC.
RESULTS


The models that integrated radiomics contours with all the clinical data were superior to those based on the clinical data alone (C-index 0.746 vs. C-index 0.814, respectively) and the calibration curves showed good consistency. The heat map showed that the radiomics expression pattern and selected histological characteristics were correlated with the clinical stage, T stage, and N stage (p < 0.05), and no radiomics feature was associated with lactate dehydrogenase expression, lymphocyte count, or mononuclear cell count.
CONCLUSION


MRI-based radiomics can significantly improve the efficacy of traditional TNM staging and clinical data in predicting the progression-free survival (PFS) of patients with advanced NPC, which may provide an opportunity for precision medicine.",2022,"MRI-based radiomics can significantly improve the efficacy of traditional TNM staging and clinical data in predicting the progression-free survival (PFS) of patients with advanced NPC, which may provide an opportunity for precision medicine.","['nasopharyngeal carcinoma with neoadjuvant chemotherapy', 'nasopharyngeal carcinoma (NPC) patients that received neoadjuvant chemotherapy', '110 NPC patients who received']","['radiotherapy and neoadjuvant chemotherapy', 'MRI-based radiomics models']","['lactate dehydrogenase expression, lymphocyte count, or mononuclear cell count', 'radiomics expression pattern and selected histological characteristics']","[{'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}]",110.0,0.0615087,"MRI-based radiomics can significantly improve the efficacy of traditional TNM staging and clinical data in predicting the progression-free survival (PFS) of patients with advanced NPC, which may provide an opportunity for precision medicine.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': ""Guangdong Medical University, Zhanjiang 524000, Department of Radiation Oncology, Foshan Academy of Medical Sciences, Sun Yat-Sen University Foshan Hospital & the First People's Hospital of Foshan, Foshan 528000, Guangdong, China.""}, {'ForeName': 'Kai-Rong', 'Initials': 'KR', 'LastName': 'Lin', 'Affiliation': ""Clinical Research Institute, Foshan Academy of Medical Sciences, Sun Yat-Sen University Foshan Hospital & the First People's Hospital of Foshan, Foshan 528000, Guangdong, China.""}, {'ForeName': 'Ya-Bin', 'Initials': 'YB', 'LastName': 'Jin', 'Affiliation': ""Clinical Research Institute, Foshan Academy of Medical Sciences, Sun Yat-Sen University Foshan Hospital & the First People's Hospital of Foshan, Foshan 528000, Guangdong, China.""}, {'ForeName': 'Hao-Jiang', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, State Key Laboratory of Oncology in Southern China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-Sen University Cancer Center, Guangzhou 510060, Guangdong, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Quan', 'Affiliation': ""Department of Radiation Oncology, Foshan Academy of Medical Sciences, Sun Yat-Sen University Foshan Hospital & the First People's Hospital of Foshan, Foshan 528000, Guangdong, China.""}, {'ForeName': 'Jian-Chun', 'Initials': 'JC', 'LastName': 'Su', 'Affiliation': ""Department of Radiation Oncology, Foshan Academy of Medical Sciences, Sun Yat-Sen University Foshan Hospital & the First People's Hospital of Foshan, Foshan 528000, Guangdong, China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ""Department of Radiation Oncology, Foshan Academy of Medical Sciences, Sun Yat-Sen University Foshan Hospital & the First People's Hospital of Foshan, Foshan 528000, Guangdong, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiation Oncology, Foshan Academy of Medical Sciences, Sun Yat-Sen University Foshan Hospital & the First People's Hospital of Foshan, Foshan 528000, Guangdong, China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': ""Department of Radiation Oncology, Foshan Academy of Medical Sciences, Sun Yat-Sen University Foshan Hospital & the First People's Hospital of Foshan, Foshan 528000, Guangdong, China.""}, {'ForeName': 'Guo-Yi', 'Initials': 'GY', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiation Oncology, Foshan Academy of Medical Sciences, Sun Yat-Sen University Foshan Hospital & the First People's Hospital of Foshan, Foshan 528000, Guangdong, China.. Electronic address: guoyizhff@163.com.""}]",Magnetic resonance imaging,['10.1016/j.mri.2022.02.005']
2189,35183892,The effect of prostacyclin infusion on markers of endothelial activation and damage in mechanically ventilated patients with SARS-CoV-2 infection.,"BACKGROUND


In a pilot study, we found a significant reduction in mean daily sequential organ failure assessment score in mechanically ventilated patients with COVID-19 who received prostacyclin, compared to placebo. We here investigate the effect on biomarkers of endothelial activation and damage.
METHODS


Post-hoc study of a randomized controlled trial in adult patients with confirmed SARS-CoV-2 infection, mechanically ventilated, with soluble thrombomodulin (sTM) plasma levels >4 ng/mL. Patients received prostacyclin infusion (1 ng/kg/min) or placebo. Blood samples were collected at baseline and 24 h.
RESULTS


Eighty patients were randomized (41 prostacyclin, 39 placebo). The median changes in syndecan-1 plasma levels at 24 h were -3.95 (IQR: -21.1 to 2.71) ng/mL in the prostacyclin group vs. 3.06 (IQR: -8.73 to 20.5) ng/mL in the placebo group (difference of the medians: -7.01 [95% CI: -22.3 to -0.231] ng/mL, corresponding to -3% [95% CI: -11% to 0%], p = 0.04). Changes in plasma levels of sTM, PECAM-1, p-selectin, and CD40L did not differ significantly between groups.
CONCLUSIONS


Prostacyclin infusion, compared to placebo, resulted in a measurable decrease in endothelial glycocalyx shedding (syndecan-1) at 24 h, suggesting a protective effect on the endothelium, which may be related to the observed reduction in organ failure.",2022,"Changes in plasma levels of sTM, PECAM-1, p-selectin, and CD40L did not differ significantly between groups.
","['mechanically ventilated patients with SARS-CoV-2 infection', 'mechanically ventilated patients with COVID-19 who received', 'adult patients with confirmed SARS-CoV-2 infection, mechanically ventilated, with soluble thrombomodulin (sTM) plasma levels >4 ng/mL. Patients received', 'Eighty patients']","['placebo', 'Prostacyclin infusion', 'prostacyclin infusion (1 ng/kg/min) or placebo', 'prostacyclin', 'prostacyclin infusion']","['mean daily sequential organ failure assessment score', 'endothelial glycocalyx shedding (syndecan-1', 'Blood samples', 'median changes in syndecan-1 plasma levels', 'plasma levels of sTM, PECAM-1, p-selectin, and CD40L', 'endothelial activation and damage']","[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033567', 'cui_str': 'Epoprostenol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1320753', 'cui_str': 'ng/kg/min'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0081939', 'cui_str': 'Lymphocyte antigen CD31'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0167627', 'cui_str': 'Lymphocyte antigen CD154'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]",80.0,0.353238,"Changes in plasma levels of sTM, PECAM-1, p-selectin, and CD40L did not differ significantly between groups.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Vigstedt', 'Affiliation': 'Department of Clinical Immunology, Rigshospitalet, Copenhagen, Denmark. Electronic address: martin.vigstedt@regionh.dk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Søe-Jensen', 'Affiliation': 'Department of Intensive Care, Herlev Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital - North Zealand, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels E', 'Initials': 'NE', 'LastName': 'Clausen', 'Affiliation': 'Department of Intensive Care, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Klaus T', 'Initials': 'KT', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Intensive Care, Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Biostatistics, University of Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Stensballe', 'Affiliation': 'Department of Clinical Immunology, Rigshospitalet, Copenhagen, Denmark; Department of Anaesthesiology, Center of Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pär I', 'Initials': 'PI', 'LastName': 'Johansson', 'Affiliation': 'Department of Clinical Immunology, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}]",Journal of critical care,['10.1016/j.jcrc.2022.154010']
2190,35183882,"Possible therapeutic effects of boron citrate and oleoylethanolamide supplementation in patients with COVID-19: A pilot randomized, double-blind, clinical trial.","BACKGROUND


The present study aimed to assess the therapeutic effects of boron citrate and oleoylethanolamide supplementation in patients with COVID-19.
METHODS


Forty adult patients with a diagnosis of COVID-19 were recruited in the present study. Patients were randomized in a 1:1:1:1 allocation ratio to 1of 4 treatment groups: (A) 5 mg of boron citrate twice a day, (B) 200 mg of oleoylethanolamide twice a day, (C) both therapies, or (D) routine treatments without any study medications. At pre-and post-intervention phase, some clinical and biochemical parameters were assessed.
RESULTS


Supplementation with boron citrate alone or in combination with oleoylethanolamide significantly improved O2 saturation and respiratory rate (p < 0.01). At the end of the study, significant increases in white blood cell and lymphocyte count were observed in the boron citrate and combined groups (p < 0.001). Boron citrate supplementation led to a significant decrease in serum lactate dehydrogenase (p = 0.026) and erythrocyte sedimentation rate (p = 0.014), compared with other groups. Furthermore, boron citrate in combination with oleoylethanolamide resulted in a significant reduction in the high-sensitivity C-reactive protein and interleukin-1β concentrations (p = 0.031 and p = 0.027, respectively). No significant differences were found among four groups post-intervention, in terms of hemoglobin concentrations, platelet count, and serum interleukin-6 levels. At the end of the study, common symptoms of COVID-19 including cough, fatigue, shortness of breath, and myalgia significantly improved in the supplemented groups, compared to the placebo (p < 0.05).
CONCLUSION


Supplementation with boron citrate alone or in combination with oleoylethanolamide could improve some clinical and biochemical parameters in COVID-19 patients.",2022,"Boron citrate supplementation led to a significant decrease in serum lactate dehydrogenase (p = 0.026) and erythrocyte sedimentation rate (p = 0.014), compared with other groups.","['COVID-19 patients', 'Forty adult patients with a diagnosis of COVID-19 were recruited in the present study', 'patients with COVID-19']","['boron citrate and oleoylethanolamide supplementation', 'oleoylethanolamide', 'placebo']","['erythrocyte sedimentation rate', 'O2 saturation and respiratory rate', 'high-sensitivity C-reactive protein and interleukin-1β concentrations', 'white blood cell and lymphocyte count', 'serum lactate dehydrogenase', 'cough, fatigue, shortness of breath, and myalgia', 'hemoglobin concentrations, platelet count, and serum interleukin-6 levels']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1110459', 'cui_str': 'BORON CITRATE'}, {'cui': 'C1454896', 'cui_str': 'oleoylethanolamide'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",40.0,0.298869,"Boron citrate supplementation led to a significant decrease in serum lactate dehydrogenase (p = 0.026) and erythrocyte sedimentation rate (p = 0.014), compared with other groups.","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Akbari', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition & Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Helda', 'Initials': 'H', 'LastName': 'Tutunchi', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Pourmoradian', 'Affiliation': 'Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition & Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Farrin', 'Affiliation': 'Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition & Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Najafipour', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Soleimanzadeh', 'Affiliation': 'Department of Applied Chemistry, Faculty of Chemistry, University of Tabriz, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Kafil', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mobasseri', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: mobasserimajid@yahoo.com.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2022.126945']
2191,35183878,Comparing exercises with and without electromyographic biofeedback in subacromial pain syndrome: A randomized controlled trial.,"BACKGROUND


Deficits in movement and muscle activation of scapulohumeral joint are related to Subacromial Pain Syndrome. Electromyography biofeedback during exercise may enhance muscle activation and coordination, and consequently improve pain and shoulder function.
METHODS


This study compared the effects of an exercise protocol with and without using electromyographic biofeedback on pain, function and movement of the shoulder complex in subjects with Subacromial Pain Syndrome. A total of 24 patients with subacromial pain (mean age = 46.2 + 8.1;18 women) were randomized to either therapeutic exercise or exercise plus biofeedback to the trapezius and serratus muscles. Pain and shoulder function were evaluated as the primary outcome and range of motion, muscle strength, electromyographic activity and scapulohumeral kinematics as secondary outcomes. The subjects underwent eight weeks of intervention and comparisons were made between groups in baseline, at 4 weeks, 8 weeks, and at 4 weeks post intervention.
FINDINGS


There were differences between groups for pain [mean difference = 1.5 (CI 0.3, 3.2) p = 0.01] at 8 weeks in the Exercise group and scapular upward rotation at 60° of arm elevation [mean difference = 13.9 (CI 0.9, 9.3), p = 0.006] in the Biofeedback group. There was no difference for the other variables of scapular kinematics as well as for shoulder function (DASH), muscle strength, range of motion and electromyographic variables.
INTERPRETATION


The addition of Biofeedback to the exercise protocol increased upward rotation of the scapula. However, the volunteers who performed only the Exercises had a better response in reducing pain.",2022,"There was no difference for the other variables of scapular kinematics as well as for shoulder function (DASH), muscle strength, range of motion and electromyographic variables.
","['subjects with Subacromial Pain Syndrome', '24 patients with subacromial pain (mean age\xa0', 'subacromial pain syndrome', '46.2\xa0+\xa08.1;18 women']","['exercises with and without electromyographic biofeedback', 'therapeutic exercise or exercise plus biofeedback to the trapezius and serratus muscles', 'Electromyography biofeedback during exercise', 'exercise protocol with and without using electromyographic biofeedback']","['shoulder function (DASH), muscle strength, range of motion and electromyographic variables', 'upward rotation of the scapula', 'pain', 'pain and shoulder function', 'scapular kinematics', 'pain, function and movement of the shoulder complex', 'Pain and shoulder function', 'range of motion, muscle strength, electromyographic activity and scapulohumeral kinematics']","[{'cui': 'C4728045', 'cui_str': 'Subacromial pain syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0204624', 'cui_str': 'Electromyographic biofeedback'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1282911', 'cui_str': 'Upward'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0036277', 'cui_str': 'Bone structure of scapula'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",24.0,0.154015,"There was no difference for the other variables of scapular kinematics as well as for shoulder function (DASH), muscle strength, range of motion and electromyographic variables.
","[{'ForeName': 'Araken Kleber Azevedo', 'Initials': 'AKA', 'LastName': 'de Oliveira', 'Affiliation': 'Universidade Federal do Rio Grande do Norte, Departamento de Fisioterapia, Campus Universitário Lagoa Nova, CEP 59078-970, Natal/RN, Brazil.'}, {'ForeName': 'Karinna Sonálya Aires', 'Initials': 'KSA', 'LastName': 'da Costa', 'Affiliation': 'Universidade Federal do Rio Grande do Norte, Departamento de Fisioterapia, Campus Universitário Lagoa Nova, CEP 59078-970, Natal/RN, Brazil.'}, {'ForeName': 'Gildásio Lucas', 'Initials': 'GL', 'LastName': 'de Lucena', 'Affiliation': 'Universidade Federal do Rio Grande do Norte, Departamento de Fisioterapia, Campus Universitário Lagoa Nova, CEP 59078-970, Natal/RN, Brazil.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'de Oliveira Sousa', 'Affiliation': 'Universidade Federal do Rio Grande do Norte, Departamento de Fisioterapia, Campus Universitário Lagoa Nova, CEP 59078-970, Natal/RN, Brazil.'}, {'ForeName': 'João Felipe Medeiros', 'Initials': 'JFM', 'LastName': 'Filho', 'Affiliation': 'Universidade Federal do Rio Grande do Norte, Departamento de Fisioterapia, Campus Universitário Lagoa Nova, CEP 59078-970, Natal/RN, Brazil.'}, {'ForeName': 'Jamilson Simões', 'Initials': 'JS', 'LastName': 'Brasileiro', 'Affiliation': 'Universidade Federal do Rio Grande do Norte, Departamento de Fisioterapia, Campus Universitário Lagoa Nova, CEP 59078-970, Natal/RN, Brazil. Electronic address: brasileiro@ufrnet.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2022.105596']
2192,35183836,The effects of 72 h of dynamic ankle immobilization on neural excitability and lower extremity kinematics.,"BACKGROUND


Ankle injuries can foster maladaptive changes in nervous system function that predisposes patients to subsequent injury. Patients are often placed in a dynamic boot immobilizer (BI) following injury; however, little is known about the effects of this treatment on neuromechanical function.
RESEARCH QUESTION


We aimed to determine the effect of 72 h of BI-use on neural excitability and lower extremity joint motion in a healthy cohort.
METHODS


Twelve uninjured individuals (20.8 ± 1.4 yrs, 1.7 ± 0.1 m, 75.2 ± 9.9 kg) participated in this crossover study. Neural excitability and lower extremity kinematics were assessed before and after 72 h of BI or compression sock (CS) use. Neural excitability was assessed via the Hoffmann (H) reflex and transcranial magnetic stimulation of the motor cortex by measuring muscle activation at the tibialis anterior, peroneus longus, and soleus of the immobilized extremity. Three-dimensional lower extremity joint angles were assessed while participants walked on a treadmill. Repeated-measures analyses of variance detected changes in neural excitability and peak joint angles across time-points and testing conditions, while statistical parametric mapping (SPM) was implemented to determine continuous joint angle changes (α = 0.05).
RESULTS


Pre-BI to post-BI, H Max :M Max  ratio (F = 6.496; p = 0.031) significantly decreased. The BI did not alter resting motor threshold (F = 0.601; p = 0.468), or motor evoked potential amplitudes (F > 2.82; p > 0.608). Significant changes in peak knee and hip angles in the frontal and transverse planes were observed (p < 0.05), with no changes at the ankle. SPM analyses revealed significant hip and knee changes in range of motion (p < 0.05).
SIGNIFICANCE


Decreased measures of reflex but not corticospinal excitability suggest that BI-use for 72 h unloaded the joint enough to generate peripheral changes, but not the CNS, as has been described in casting models. Further, kinematic changes were observed in proximal lower extremity joints, likely due to swing-phase adaptations while wearing the BI.",2022,"Significant changes in peak knee and hip angles in the frontal and transverse planes were observed (p < 0.05), with no changes at the ankle.","['predisposes patients to subsequent injury', 'Twelve uninjured individuals (20.8\xa0±\xa01.4\xa0yrs, 1.7\xa0±\xa00.1\xa0m, 75.2\xa0±\xa09.9\xa0kg', 'a healthy cohort']",['dynamic ankle immobilization'],"['neural excitability and peak joint angles across time-points and testing conditions, while statistical parametric mapping (SPM', 'Neural excitability and lower extremity kinematics', 'H Max :M Max  ratio', 'motor evoked potential amplitudes', 'neural excitability and lower extremity joint motion', 'extremity joint angles', 'resting motor threshold', 'neural excitability and lower extremity kinematics', 'peak knee and hip angles in the frontal and transverse planes', 'corticospinal excitability', 'Neural excitability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0584731', 'cui_str': 'Joint structure of lower extremity'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}]",,0.036021,"Significant changes in peak knee and hip angles in the frontal and transverse planes were observed (p < 0.05), with no changes at the ankle.","[{'ForeName': 'Jasmine J', 'Initials': 'JJ', 'LastName': 'Cash', 'Affiliation': 'Department of Health Sciences and Research, Medical University of South Carolina, Charleston, SC, USA. Electronic address: cashja@musc.edu.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'van Werkhoven', 'Affiliation': 'Department of Health and Exercise Science, Appalachian State University, Boone, NC, USA. Electronic address: vanwerkhovenh@appstate.edu.'}, {'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Cole', 'Affiliation': 'Department of Health and Exercise Science, Appalachian State University, Boone, NC, USA. Electronic address: colekj@appstate.edu.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Needle', 'Affiliation': 'Department of Health and Exercise Science, Appalachian State University, Boone, NC, USA. Electronic address: needlear@appstate.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2022.02.005']
2193,35188677,Effect of high frequency versus theta-burst repetitive transcranial magnetic stimulation on suicidality in patients with treatment-resistant depression.,"OBJECTIVE


To investigate the effect of 10 Hz repetitive transcranial magnetic stimulation (rTMS) and intermittent theta-burst stimulation (iTBS) on suicidality in patients with treatment-resistant depression (TRD).
METHODS


We used data from a three-site randomized clinical trial comparing 10 Hz rTMS and iTBS applied to the left dorsolateral prefrontal cortex (DLPFC) in patients with TRD. We compared the effect of 10Hz rTMS and iTBS on suicidality as measured by the suicide item of the Hamilton Depression Rating Scale 17-item (HDRS-17).
RESULTS


Suicidality remitted in 71 (43.7%) participants randomized to 10Hz stimulation and 91 (49.1%) participants randomized to iTBS, without a significant difference between the proportions in the two groups (Χ 2   = 0.674, df = 1, p = 0.4117). There was a significant correlation between change in suicidality and change in depression severity for both modalities (10 Hz, Pearson's r = 0.564; iTBS, Pearson's r = 0.502), with a significantly larger decrease in depression severity for those in whom suicidality remitted compared to those in whom it did not (t = 10.912, df = 276.8, p < 0.001).
CONCLUSIONS


Both 10 Hz and iTBS rTMS were effective in reducing suicidality in TRD. Future trials of iTBS for depression should include discrete measures of suicidality.",2022,"There was a significant correlation between change in suicidality and change in depression severity for both modalities (10Hz, Pearson's r = 0.564; iTBS, Pearson's r = 0.502), with a significantly larger decrease in depression severity for those in whom suicidality remitted compared to those in whom it did not (t = 10.912, df = 276.8, p < 0.001).
","['patients with treatment resistant depression', 'patients with TRD', 'Patients with Treatment Resistant Depression']","['High Frequency Versus Theta-Burst Repetitive Transcranial Magnetic Stimulation', '10Hz and iTBS rTMS', '10Hz rTMS and iTBS', '10Hz repetitive transcranial magnetic stimulation (rTMS) and intermittent theta-burst stimulation (iTBS']","['suicidality and change in depression severity', 'depression severity', 'Hamilton Depression Rating Scale 17-item (HDRS-17']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",,0.0293365,"There was a significant correlation between change in suicidality and change in depression severity for both modalities (10Hz, Pearson's r = 0.564; iTBS, Pearson's r = 0.502), with a significantly larger decrease in depression severity for those in whom suicidality remitted compared to those in whom it did not (t = 10.912, df = 276.8, p < 0.001).
","[{'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Voineskos', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Cory R', 'Initials': 'CR', 'LastName': 'Weissman', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Fidel', 'Initials': 'F', 'LastName': 'Vila-Rodriguez', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13412']
2194,35189544,The effects of cerebrospinal fluid (CSF) diversion on post-operative CSF leak following extended endoscopic anterior skull base surgery.,"There is a paucity of high quality evidence regarding the routine placement of lumbar drain (LD) in reducing post-operative (op) cerebrospinal fluid (CSF) leak after extended endoscopic trans-sphenoidal resection of anterior skull base lesions. In this study, we sought to compare the incidence of post-op CSF leak between patients with upfront LD insertion and those without it. This was a prospective randomized controlled trial conducted over a period of 5 years with patients undergoing extended endoscopic trans-sphenoidal surgery randomly assigned to either LD insertion at the time of surgery, or no LD placement. Thirty-eight patients with anterior skull base tumors were accrued from three tertiary hospitals of Melbourne. Post-op leak was confirmed by β2-transferrin-positive rhinorrhea, and/or worsening pneumocephalus on brain imaging. Skull base defect size and pedicled nasoseptal flap viability were assessed on post-op CT and MRI, respectively. There was no significant difference in post-op CSF leak incidence between the two subgroups (12.50% in LD arm vs. 9.10% in no LD arm). Patients with LD insertion however, demonstrated substantially raised complication rates, longer hospital lengths of stay and lower subjective quality of life measures at 12 months compared with those without LD. In conclusion, routine placement of LD at the time of surgery for extended anterior skull base trans-nasal approach did not reduce the risk of post-op CSF leak. Discretion is warranted when using LD as an adjunct due to its associated morbidities, prolonged hospital stay and adverse effect on patients' subjective outcome measures.",2022,"Patients with LD insertion however, demonstrated substantially raised complication rates, longer hospital lengths of stay and lower subjective quality of life measures at 12 months compared with those without LD.","['patients with upfront LD insertion and those without it', 'extended endoscopic anterior skull base surgery', 'Thirty-eight patients with anterior skull base tumors were accrued from three tertiary hospitals of Melbourne', '5\xa0years with patients undergoing extended endoscopic trans-sphenoidal surgery randomly assigned to either']","['LD insertion at the time of surgery, or no LD placement', 'cerebrospinal fluid (CSF) diversion']","['raised complication rates, longer hospital lengths of stay and lower subjective quality of life measures', 'incidence of post-op CSF leak', 'Skull base defect size and pedicled nasoseptal flap viability', 'risk of post-op CSF leak', 'post-op CSF leak incidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0149543', 'cui_str': 'Base of skull structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0376527', 'cui_str': 'Neoplasms, Skull Base'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456195', 'cui_str': 'Sphenoidal'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3495845', 'cui_str': 'Drain placement'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0185033', 'cui_str': 'Diversion procedure'}]","[{'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023182', 'cui_str': 'Cerebrospinal fluid leak'}, {'cui': 'C0149543', 'cui_str': 'Base of skull structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",38.0,0.0524457,"Patients with LD insertion however, demonstrated substantially raised complication rates, longer hospital lengths of stay and lower subjective quality of life measures at 12 months compared with those without LD.","[{'ForeName': 'Cecilia W', 'Initials': 'CW', 'LastName': 'Huo', 'Affiliation': ""Department of Neurosurgery, St Vincent's Hospital Melbourne, VIC 3065, Australia. Electronic address: Cecilia.Huo@mh.org.au.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'King', 'Affiliation': 'Department of Neurosurgery, The Royal Melbourne Hospital, VIC 3050, Australia.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Goldschlager', 'Affiliation': 'Department of Neurosurgery, Monash Medical Centre, VIC 3168, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Dixon', 'Affiliation': ""The Head and Neck/ENT Unit, St Vincent's Hospital Melbourne, VIC 3065, Australia.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen Zhao', 'Affiliation': 'The Head and Neck/ENT Unit, The Royal Melbourne Hospital, VIC 3050, Australia.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Uren', 'Affiliation': 'The Head and Neck/ENT Unit, Monash Medical Centre, VIC 3168, Australia.'}, {'ForeName': 'Yi Yuen', 'Initials': 'YY', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, St Vincent's Hospital Melbourne, VIC 3065, Australia; Department of Surgery, The University of Melbourne, VIC Australia.""}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2022.02.006']
2195,35190534,"Effect of biannual azithromycin distribution on antibody responses to malaria, bacterial, and protozoan pathogens in Niger.","The MORDOR trial in Niger, Malawi, and Tanzania found that biannual mass distribution of azithromycin to children younger than 5 years led to a 13.5% reduction in all-cause mortality (NCT02048007). To help elucidate the mechanism for mortality reduction, we report IgG responses to 11 malaria, bacterial, and protozoan pathogens using a multiplex bead assay in pre-specified substudy of 30 communities in the rural Niger placebo-controlled trial over a three-year period (n = 5642 blood specimens, n = 3814 children ages 1-59 months). Mass azithromycin reduces Campylobacter spp. force of infection by 29% (hazard ratio = 0.71, 95% CI: 0.56, 0.89; P = 0.004) but serological measures show no significant differences between groups for other pathogens against a backdrop of high transmission. Results align with a recent microbiome study in the communities. Given significant sequelae of Campylobacter infection among preschool aged children, our results support an important mechanism through which biannual mass distribution of azithromycin likely reduces mortality in Niger.",2022,Mass azithromycin reduces Campylobacter spp.,"['preschool aged children', 'Niger', '30 communities in the rural Niger placebo-controlled trial over a three-year period (n\u2009=\u20095642 blood specimens, n\u2009=\u20093814 children ages 1-59 months']","['azithromycin', 'biannual azithromycin']","['Campylobacter infection', 'force of infection', 'antibody responses to malaria, bacterial, and protozoan pathogens']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0006818', 'cui_str': 'Campylobacteriosis'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0033739', 'cui_str': 'Kingdom Protozoa'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}]",3814.0,0.151372,Mass azithromycin reduces Campylobacter spp.,"[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center, Niger, Niamey, Niger.'}, {'ForeName': 'Ramatou', 'Initials': 'R', 'LastName': 'Maliki', 'Affiliation': 'The Carter Center, Niger, Niamey, Niger.'}, {'ForeName': 'E Brook', 'Initials': 'EB', 'LastName': 'Goodhew', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rogier', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Priest', 'Affiliation': 'Division of Foodborne, Waterborne and Environmental Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Le', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Martin', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, CA, USA. ben.arnold@ucsf.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nature communications,['10.1038/s41467-022-28565-5']
2196,35191972,Effect of Artificial Intelligence Tutoring vs Expert Instruction on Learning Simulated Surgical Skills Among Medical Students: A Randomized Clinical Trial.,"Importance


To better understand the emerging role of artificial intelligence (AI) in surgical training, efficacy of AI tutoring systems, such as the Virtual Operative Assistant (VOA), must be tested and compared with conventional approaches.
Objective


To determine how VOA and remote expert instruction compare in learners' skill acquisition, affective, and cognitive outcomes during surgical simulation training.
Design, Setting, and Participants


This instructor-blinded randomized clinical trial included medical students (undergraduate years 0-2) from 4 institutions in Canada during a single simulation training at McGill Neurosurgical Simulation and Artificial Intelligence Learning Centre, Montreal, Canada. Cross-sectional data were collected from January to April 2021. Analysis was conducted based on intention-to-treat. Data were analyzed from April to June 2021.
Interventions


The interventions included 5 feedback sessions, 5 minutes each, during a single 75-minute training, including 5 practice sessions followed by 1 realistic virtual reality brain tumor resection. The 3 intervention arms included 2 treatment groups, AI audiovisual metric-based feedback (VOA group) and synchronous verbal scripted debriefing and instruction from a remote expert (instructor group), and a control group that received no feedback.
Main Outcomes and Measures


The coprimary outcomes were change in procedural performance, quantified as Expertise Score by a validated assessment algorithm (Intelligent Continuous Expertise Monitoring System [ICEMS]; range, -1.00 to 1.00) for each practice resection, and learning and retention, measured from performance in realistic resections by ICEMS and blinded Objective Structured Assessment of Technical Skills (OSATS; range 1-7). Secondary outcomes included strength of emotions before, during, and after the intervention and cognitive load after intervention, measured in self-reports.
Results


A total of 70 medical students (41 [59%] women and 29 [41%] men; mean [SD] age, 21.8 [2.3] years) from 4 institutions were randomized, including 23 students in the VOA group, 24 students in the instructor group, and 23 students in the control group. All participants were included in the final analysis. ICEMS assessed 350 practice resections, and ICEMS and OSATS evaluated 70 realistic resections. VOA significantly improved practice Expertise Scores by 0.66 (95% CI, 0.55 to 0.77) points compared with the instructor group and by 0.65 (95% CI, 0.54 to 0.77) points compared with the control group (P < .001). Realistic Expertise Scores were significantly higher for the VOA group compared with instructor (mean difference, 0.53 [95% CI, 0.40 to 0.67] points; P < .001) and control (mean difference. 0.49 [95% CI, 0.34 to 0.61] points; P < .001) groups. Mean global OSATS ratings were not statistically significant among the VOA (4.63 [95% CI, 4.06 to 5.20] points), instructor (4.40 [95% CI, 3.88-4.91] points), and control (3.86 [95% CI, 3.44 to 4.27] points) groups. However, on the OSATS subscores, VOA significantly enhanced the mean OSATS overall subscore compared with the control group (mean difference, 1.04 [95% CI, 0.13 to 1.96] points; P = .02), whereas expert instruction significantly improved OSATS subscores for instrument handling vs control (mean difference, 1.18 [95% CI, 0.22 to 2.14]; P = .01). No significant differences in cognitive load, positive activating, and negative emotions were found.
Conclusions and Relevance


In this randomized clinical trial, VOA feedback demonstrated superior performance outcome and skill transfer, with equivalent OSATS ratings and cognitive and emotional responses compared with remote expert instruction, indicating advantages for its use in simulation training.
Trial Registration


ClinicalTrials.gov Identifier: NCT04700384.",2022,"VOA significantly improved practice Expertise Scores by 0.66 (95% CI, 0.55 to 0.77) points compared with the instructor group and by 0.65 (95% CI, 0.54 to 0.77) points compared with the control group (P < .001).","['Medical Students', '70 medical students (41 [59%] women and 29 [41%] men; mean [SD] age, 21.8 [2.3] years) from 4 institutions were randomized, including 23 students in the VOA group, 24 students in the instructor group, and 23 students in the control group', 'medical students (undergraduate years 0-2) from 4 institutions in Canada during a single simulation training at McGill Neurosurgical Simulation and Artificial Intelligence Learning Centre, Montreal, Canada']","['remote expert instruction', 'VOA', 'Artificial Intelligence Tutoring vs Expert Instruction', 'AI audiovisual metric-based feedback (VOA group) and synchronous verbal scripted debriefing and instruction from a remote expert (instructor group), and a control group that received no feedback']","['Mean global OSATS ratings', 'cognitive load, positive activating, and negative emotions', 'strength of emotions before, during, and after the intervention and cognitive load after intervention, measured in self-reports', 'Realistic Expertise Scores', 'OSATS subscores', ""learners' skill acquisition, affective, and cognitive outcomes"", 'superior performance outcome and skill transfer, with equivalent OSATS ratings and cognitive and emotional responses', 'Learning Simulated Surgical Skills', 'mean OSATS overall subscore', 'change in procedural performance, quantified as Expertise Score by a validated assessment algorithm (Intelligent Continuous Expertise Monitoring System [ICEMS]; range, -1.00 to 1.00) for each practice resection, and learning and retention, measured from performance in realistic resections by ICEMS and blinded Objective Structured Assessment of Technical Skills', 'practice Expertise Scores']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449851', 'cui_str': 'Technique'}]",70.0,0.291268,"VOA significantly improved practice Expertise Scores by 0.66 (95% CI, 0.55 to 0.77) points compared with the instructor group and by 0.65 (95% CI, 0.54 to 0.77) points compared with the control group (P < .001).","[{'ForeName': 'Ali M', 'Initials': 'AM', 'LastName': 'Fazlollahi', 'Affiliation': 'Neurosurgical Simulation and Artificial Intelligence Learning Centre, Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, McGill University, Montreal, Canada.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Bakhaidar', 'Affiliation': 'Neurosurgical Simulation and Artificial Intelligence Learning Centre, Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, McGill University, Montreal, Canada.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alsayegh', 'Affiliation': 'Neurosurgical Simulation and Artificial Intelligence Learning Centre, Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, McGill University, Montreal, Canada.'}, {'ForeName': 'Recai', 'Initials': 'R', 'LastName': 'Yilmaz', 'Affiliation': 'Neurosurgical Simulation and Artificial Intelligence Learning Centre, Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, McGill University, Montreal, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Winkler-Schwartz', 'Affiliation': 'Neurosurgical Simulation and Artificial Intelligence Learning Centre, Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, McGill University, Montreal, Canada.'}, {'ForeName': 'Nykan', 'Initials': 'N', 'LastName': 'Mirchi', 'Affiliation': 'Neurosurgical Simulation and Artificial Intelligence Learning Centre, Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, McGill University, Montreal, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Langleben', 'Affiliation': 'Neurosurgical Simulation and Artificial Intelligence Learning Centre, Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, McGill University, Montreal, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ledwos', 'Affiliation': 'Neurosurgical Simulation and Artificial Intelligence Learning Centre, Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, McGill University, Montreal, Canada.'}, {'ForeName': 'Abdulrahman J', 'Initials': 'AJ', 'LastName': 'Sabbagh', 'Affiliation': 'Division of Neurosurgery, Department of Surgery, College of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Bajunaid', 'Affiliation': 'Department of Surgery, College of Medicine, University of Jeddah, Jeddah, Saudi Arabia.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Harley', 'Affiliation': 'Department of Surgery, McGill University, Montreal, Canada.'}, {'ForeName': 'Rolando F', 'Initials': 'RF', 'LastName': 'Del Maestro', 'Affiliation': 'Neurosurgical Simulation and Artificial Intelligence Learning Centre, Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, McGill University, Montreal, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.49008']
2197,35191923,"Effect of Intra-arrest Transport, Extracorporeal Cardiopulmonary Resuscitation, and Immediate Invasive Assessment and Treatment on Functional Neurologic Outcome in Refractory Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial.","Importance


Out-of-hospital cardiac arrest (OHCA) has poor outcome. Whether intra-arrest transport, extracorporeal cardiopulmonary resuscitation (ECPR), and immediate invasive assessment and treatment (invasive strategy) is beneficial in this setting remains uncertain.
Objective


To determine whether an early invasive approach in adults with refractory OHCA improves neurologically favorable survival.
Design, Setting, and Participants


Single-center, randomized clinical trial in Prague, Czech Republic, of adults with a witnessed OHCA of presumed cardiac origin without return of spontaneous circulation. A total of 256 participants, of a planned sample size of 285, were enrolled between March 2013 and October 2020. Patients were observed until death or day 180 (last patient follow-up ended on March 30, 2021).
Interventions


In the invasive strategy group (n = 124), mechanical compression was initiated, followed by intra-arrest transport to a cardiac center for ECPR and immediate invasive assessment and treatment. Regular advanced cardiac life support was continued on-site in the standard strategy group (n = 132).
Main Outcomes and Measures


The primary outcome was survival with a good neurologic outcome (defined as Cerebral Performance Category [CPC] 1-2) at 180 days after randomization. Secondary outcomes included neurologic recovery at 30 days (defined as CPC 1-2 at any time within the first 30 days) and cardiac recovery at 30 days (defined as no need for pharmacological or mechanical cardiac support for at least 24 hours).
Results


The trial was stopped at the recommendation of the data and safety monitoring board when prespecified criteria for futility were met. Among 256 patients (median age, 58 years; 44 [17%] women), 256 (100%) completed the trial. In the main analysis, 39 patients (31.5%) in the invasive strategy group and 29 (22.0%) in the standard strategy group survived to 180 days with good neurologic outcome (odds ratio [OR], 1.63 [95% CI, 0.93 to 2.85]; difference, 9.5% [95% CI, -1.3% to 20.1%]; P = .09). At 30 days, neurologic recovery had occurred in 38 patients (30.6%) in the invasive strategy group and in 24 (18.2%) in the standard strategy group (OR, 1.99 [95% CI, 1.11 to 3.57]; difference, 12.4% [95% CI, 1.9% to 22.7%]; P = .02), and cardiac recovery had occurred in 54 (43.5%) and 45 (34.1%) patients, respectively (OR, 1.49 [95% CI, 0.91 to 2.47]; difference, 9.4% [95% CI, -2.5% to 21%]; P = .12). Bleeding occurred more frequently in the invasive strategy vs standard strategy group (31% vs 15%, respectively).
Conclusions and Relevance


Among patients with refractory out-of-hospital cardiac arrest, the bundle of early intra-arrest transport, ECPR, and invasive assessment and treatment did not significantly improve survival with neurologically favorable outcome at 180 days compared with standard resuscitation. However, the trial was possibly underpowered to detect a clinically relevant difference.
Trial Registration


ClinicalTrials.gov Identifier: NCT01511666.",2022,"Bleeding occurred more frequently in the invasive strategy vs standard strategy group (31% vs 15%, respectively).
","['Participants\n\n\nSingle-center, randomized clinical trial in Prague, Czech Republic, of adults with a witnessed OHCA of presumed cardiac origin without return of spontaneous circulation', 'A total of 256 participants, of a planned sample size of 285, were enrolled between March 2013 and October 2020', 'patients with refractory out-of-hospital cardiac arrest', '256 patients (median age, 58 years; 44 [17%] women), 256 (100%) completed the trial', 'Refractory Out-of-Hospital Cardiac Arrest', 'adults with refractory OHCA']","['hospital cardiac arrest (OHCA', 'mechanical compression', 'Intra-arrest Transport, Extracorporeal Cardiopulmonary Resuscitation, and Immediate Invasive Assessment and Treatment', 'extracorporeal cardiopulmonary resuscitation (ECPR), and immediate invasive assessment and treatment (invasive strategy']","['neurologic recovery', 'survival', 'survival with a good neurologic outcome', 'good neurologic outcome', 'cardiac recovery', 'Bleeding', 'neurologic recovery at 30 days (defined as CPC 1-2 at any time within the first 30 days) and cardiac recovery', 'Functional Neurologic Outcome']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0563291', 'cui_str': 'Mechanical compression'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",256.0,0.390468,"Bleeding occurred more frequently in the invasive strategy vs standard strategy group (31% vs 15%, respectively).
","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Belohlavek', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Smalcova', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rob', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Franek', 'Affiliation': 'Emergency Medical Service, Prague, Czech Republic.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Smid', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Milana', 'Initials': 'M', 'LastName': 'Pokorna', 'Affiliation': 'Emergency Medical Service, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Horák', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Vratislav', 'Initials': 'V', 'LastName': 'Mrazek', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Kovarnik', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zemanek', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Ales', 'Initials': 'A', 'LastName': 'Kral', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Stepan', 'Initials': 'S', 'LastName': 'Havranek', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Kavalkova', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Kompelentova', 'Affiliation': 'Emergency Medical Service, Prague, Czech Republic.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Tomková', 'Affiliation': 'Emergency Medical Service, Prague, Czech Republic.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Mejstrik', 'Affiliation': 'Emergency Medical Service, Prague, Czech Republic.'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Valasek', 'Affiliation': 'Emergency Medical Service, Prague, Czech Republic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peran', 'Affiliation': 'Emergency Medical Service, Prague, Czech Republic.'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Pekara', 'Affiliation': 'Emergency Medical Service, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Rulisek', 'Affiliation': 'Department of Anesthesiology, Resuscitation and Intensive Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Balik', 'Affiliation': 'Department of Anesthesiology, Resuscitation and Intensive Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Huptych', 'Affiliation': 'Czech Institute of Informatics, Robotics and Cybernetics (CIIRC), Czech Technical University, Prague, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Jarkovsky', 'Affiliation': 'Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Malik', 'Affiliation': '3rd Department of Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Valerianova', 'Affiliation': '3rd Department of Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Frantisek', 'Initials': 'F', 'LastName': 'Mlejnsky', 'Affiliation': '2nd Department of Surgery, Cardiovascular Surgery, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kolouch', 'Affiliation': 'Emergency Medical Service, Prague, Czech Republic.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Havrankova', 'Affiliation': 'Department of Neurology, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Romportl', 'Affiliation': 'Long-term Intensive Care Unit, Etoile, Prague, Czech Republic.'}, {'ForeName': 'Arnost', 'Initials': 'A', 'LastName': 'Komarek', 'Affiliation': 'Department of Probability and Mathematical Statistics, Faculty of Mathematics and Physics, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Ales', 'Initials': 'A', 'LastName': 'Linhart', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2022.1025']
2198,35191924,Effect of Sublingual Dexmedetomidine vs Placebo on Acute Agitation Associated With Bipolar Disorder: A Randomized Clinical Trial.,"Importance


Acute agitation is common in patients with bipolar disorder and requires urgent management to relieve distress and to prevent escalation to aggressive behavior.
Objective


To evaluate the effect of orally absorbed, sublingual dexmedetomidine, a selective α2A-adrenergic receptor agonist on symptoms of acute agitation in patients with bipolar disorder.
Design, Setting, and Participants


Phase 3, randomized, double-blind, placebo-controlled trial conducted in 15 sites in the US with enrollment between February 24, 2020, and April 27, 2020, and final follow-up on May 21, 2020. A total of 380 adults with bipolar I or II disorder were randomized and 362 completed the study.
Interventions


Participants were randomized to 3 groups: sublingual dexmedetomidine 180 μg (n = 127), sublingual dexmedetomidine 120 μg (n = 127), or placebo (n = 126).
Main Outcomes and Measures


The primary efficacy end point was the mean change from baseline at 2 hours for the Positive and Negative Syndrome Scale-Excited Component (PEC) total score. The range of possible total scores is 5 (absence of agitation) to 35 (extremely severe). The secondary end point was the earliest time of a statistically significant change in PEC total score from baseline for the drug vs placebo. On the primary efficacy end point, to account for multiplicity associated with comparing 2 sublingual dexmedetomidine doses with placebo, the 2-sided significance level for each dose vs placebo was set at .025.
Results


Of 380 patients randomized (mean age, 45.6 years; 54.8% women; and 56.1% Black individuals), 378 (99.5%) self-administered the study medication and completed the study. Baseline agitation was mild to moderate, with an overall mean PEC total score of 18.0. Two hours after taking the medication, the mean changes from baseline in PEC total score were -10.4 for sublingual dexmedetomidine 180 μg, -9.0 for sublingual dexmedetomidine 120 μg, and -4.9 for placebo. Least-square mean differences from placebo in the sublingual dexmedetomidine groups at 2 hours were -5.4 (97.5% CI, -6.6 to -4.2) for 180 μg and -4.1 (97.5% CI, -5.3 to -2.9) for 120 μg (both doses P < .001 vs placebo). Treatment effects began 20 minutes after taking the medication among patients in the sublingual dexmedetomidine groups (least-square mean difference for 180 μg, -1.1 [97.5% CI, -2.0 to -0.2]; P = .007; for 120 μg, -1.0 [97.5% CI, -1.9 to -0.1]; P = .009). Adverse events occurred in 35.7% of patients taking 180 μg of dexmedetomidine, 34.9% taking 120 μg, and 17.5% taking placebo. The most common adverse events (≥5%) in the respective 180 μg, 120 μg, and placebo groups were somnolence (21.4% and 20.6% vs 4.8%); dry mouth (4.8% and 7.1% vs 0.8%); hypotension (6.3% and 4.8% vs 0%); and dizziness (5.6% and 5.6% vs 0.8%).
Conclusions and Relevance


Among patients with mild to moderate agitation associated with bipolar disorder, treatment with a sublingual film formulation of dexmedetomidine 120 μg or 180 μg, compared with placebo, resulted in significantly greater reduction in the agitation score at 2 hours. Further research is needed to understand the spectrum of patients for whom this treatment would be effective and feasible and to better understand the clinical importance of the observed effect size.
Trial Registration


ClinicalTrials.gov Identifier: NCT04276883.",2022,"The most common adverse events (≥5%) in the respective 180 μg, 120 μg, and placebo groups were somnolence (21.4% and 20.6% vs 4.8%); dry mouth (4.8% and 7.1% vs 0.8%); hypotension (6.3% and 4.8% vs 0%); and dizziness (5.6% and 5.6% vs 0.8%).
","['controlled trial conducted in 15 sites in the US with enrollment between February 24, 2020, and April 27, 2020, and final follow-up on May 21, 2020', '380 adults with bipolar I or II disorder were randomized and 362 completed the study', 'patients with bipolar disorder', 'Acute Agitation Associated With Bipolar Disorder', '380 patients randomized (mean age, 45.6 years; 54.8% women; and 56.1% Black individuals), 378 (99.5%) self-administered the study medication and completed the study', 'patients with mild to moderate agitation associated with bipolar disorder']","['placebo', 'dexmedetomidine', 'sublingual dexmedetomidine', 'Sublingual Dexmedetomidine vs Placebo']","['dizziness', 'Baseline agitation', 'agitation score', 'PEC total score', 'somnolence', 'mean change from baseline at 2 hours for the Positive and Negative Syndrome Scale-Excited Component (PEC) total score', 'hypotension', 'Adverse events']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517912', 'cui_str': '99.5'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",380.0,0.501722,"The most common adverse events (≥5%) in the respective 180 μg, 120 μg, and placebo groups were somnolence (21.4% and 20.6% vs 4.8%); dry mouth (4.8% and 7.1% vs 0.8%); hypotension (6.3% and 4.8% vs 0%); and dizziness (5.6% and 5.6% vs 0.8%).
","[{'ForeName': 'Sheldon H', 'Initials': 'SH', 'LastName': 'Preskorn', 'Affiliation': 'Kansas University School of Medicine-Wichita, Wichita.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Zeller', 'Affiliation': 'Department of Psychiatry, University of California-Riverside School of Medicine, Riverside.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Citrome', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Finman', 'Affiliation': 'Jupiter Point Pharma Consulting, LLC, Groton, Connecticut.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Goldberg', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Kakar', 'Affiliation': 'Segal Trials, Ft Lauderdale, Florida.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'De Vivo', 'Affiliation': 'BioXcel Therapeutics, New Haven, Connecticut.'}, {'ForeName': 'Frank D', 'Initials': 'FD', 'LastName': 'Yocca', 'Affiliation': 'BioXcel Therapeutics, New Haven, Connecticut.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Risinger', 'Affiliation': 'BioXcel Therapeutics, New Haven, Connecticut.'}]",JAMA,['10.1001/jama.2022.0799']
2199,35195015,Feasibility and Short-Term Effects of a Multi-Component Emergency Department Blood Pressure Intervention: A Pilot Randomized Trial.,"Background Emergency department (ED) visits can be opportunities to address uncontrolled hypertension. We sought to compare short-term blood pressure measures between the Vanderbilt Emergency Room Bundle (VERB) intervention and usual care plus education. Methods and Results We conducted a randomized trial of 206 adult patients with hypertension and elevated systolic blood pressure (SBP) presenting to 2 urban emergency departments in Tennessee, USA. The VERB intervention included educational materials, a brief motivational interview, pillbox, primary care engagement letter, pharmacy resources, and 45 days of informational and reminder text messages. The education arm received a hypertension pamphlet. After 78 participants were enrolled, text messages requested confirmation of receipt. The primary clinical outcome was 30-day SBP. The median 30-day SBP was 122 and 126 mm Hg in the VERB and education arms, respectively. We estimated the mean 30-day SBP to be 3.98 mm Hg lower in the VERB arm (95% CI, -2.44 to 10.4;  P =0.22). Among participants enrolled after text messages were adapted, the respective median SBPs were 121 and 130 mm Hg, and we estimated the mean 30-day SBP to be 8.57 mm Hg lower in the VERB arm (95% CI, 0.98‒16.2;  P =0.027). In this subgroup, the median response rate to VERB text messages was 56% (interquartile range, [26%‒80%]). Conclusions This pilot study demonstrated feasibility and found an improvement in SBP for the subgroup for whom interactive messages were featured. Future studies should evaluate the role of interactive text messaging as part of a comprehensive emergency department intervention to improve blood pressure control. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02672787.",2022,"Hg lower in the VERB arm (95% CI, -2.44 to 10.4;  P =0.22).","['206 adult patients with hypertension and elevated systolic blood pressure (SBP) presenting to 2 urban emergency departments in Tennessee, USA', 'participants enrolled after text messages were adapted, the respective median SBPs were 121 and 130\xa0mm', '78 participants were enrolled, text messages requested confirmation of receipt']","['Multi-Component Emergency Department Blood Pressure Intervention', 'Vanderbilt Emergency Room Bundle (VERB) intervention and usual care plus education', 'hypertension pamphlet']","['median response rate to VERB text messages', 'blood pressure control', 'mean 30-day SBP', '30-day SBP', 'educational materials, a brief motivational interview, pillbox, primary care engagement letter, pharmacy resources, and 45\xa0days of informational and reminder text messages', 'median 30-day SBP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0039514', 'cui_str': 'Tennessee'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",206.0,0.183244,"Hg lower in the VERB arm (95% CI, -2.44 to 10.4;  P =0.22).","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Spieker', 'Affiliation': 'Department of Biostatistics Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Lyndsay A', 'Initials': 'LA', 'LastName': 'Nelson', 'Affiliation': 'Department of Medicine Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Rothman', 'Affiliation': 'Institute for Medicine and Public Health Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Christianne L', 'Initials': 'CL', 'LastName': 'Roumie', 'Affiliation': 'Department of Medicine Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kripalani', 'Affiliation': 'Department of Medicine Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Coco', 'Affiliation': 'Department of Biomedical Informatics Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fabbri', 'Affiliation': 'Department of Biomedical Informatics Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Levy', 'Affiliation': 'Department of Emergency Medicine Wayne State University Detroit MI.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Internal Medicine University of Texas Southwestern Medical Center Dallas TX.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Candace D', 'Initials': 'CD', 'LastName': 'McNaughton', 'Affiliation': 'Department of Emergency Medicine Vanderbilt University Medical Center Nashville TN.'}]",Journal of the American Heart Association,['10.1161/JAHA.121.024339']
2200,35182906,Changes in emotion processing and social cognition with auditory versus visual neuroscience-informed cognitive training in individuals with schizophrenia.,"BACKGROUND


Neuroscience-informed cognitive training has been used to remediate cognitive deficits in schizophrenia, but their effect on emotion processing and social cognition deficits, which may involve auditory and visual impairments, remain relatively unknown. In this study, we compared the efficacy of auditory versus visual neuroscience-informed cognitive training on emotion processing and social cognition in individuals with schizophrenia.
METHODS


In this randomised, double-blind clinical trial, 79 participants with chronic schizophrenia performed 40-hours auditory or visual dynamically equivalent computerised cognitive training. We assessed emotion processing and social cognition using Emotion Recognition, Affective Go-NoGo, Mayer-Salovey-Caruso Emotional-Intelligence, Theory of mind, and Hinting tests before and after 20 h and 40 h of training.
RESULTS


After training, participants from both groups decreased their reaction time for facial emotion recognition (p = 3 × 10 -6 , d = 0.9). This was more remarkable for the auditory group when analysing individual emotions. Both groups also reduced omissions in the affective go-no go (p = 0.01, d = 0.6), which was also attributed, post hoc, to the auditory group. Trends for improvement were observed in theory of mind (p = 0.06, d = 0.6) for both groups. Improvement in emotion processing was associated with improvement in reasoning and problem solving and global cognition and improvement in theory of mind was associated with improvement in attention and global cognition.
CONCLUSIONS


Both the auditory and the visual neuroscience-informed cognitive training were efficacious at improving emotion processing and social cognition in individuals with schizophrenia, although improvement was more remarkable for the auditory training group. These improvements were related to cognitive - but not symptom - improvement.",2022,"Improvement in emotion processing was associated with improvement in reasoning and problem solving and global cognition and improvement in theory of mind was associated with improvement in attention and global cognition.
","['individuals with schizophrenia', '79 participants with chronic schizophrenia performed 40-hours auditory or visual dynamically equivalent computerised cognitive training']","['visual neuroscience-informed cognitive training', 'auditory versus visual neuroscience-informed cognitive training']","['reasoning and problem solving and global cognition', 'emotion processing and social cognition using Emotion Recognition, Affective Go-NoGo, Mayer-Salovey-Caruso Emotional-Intelligence, Theory of mind, and Hinting tests', 'emotion processing', 'reaction time for facial emotion recognition', 'emotion processing and social cognition', 'attention and global cognition']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0221765', 'cui_str': 'Chronic schizophrenia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]","[{'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C1510539', 'cui_str': 'Emotional Intelligence'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",79.0,0.0437545,"Improvement in emotion processing was associated with improvement in reasoning and problem solving and global cognition and improvement in theory of mind was associated with improvement in attention and global cognition.
","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Scoriels', 'Affiliation': 'Institut de Psychiatrie et Neurosciences de Paris, Inserm - Université Paris Descartes, France; Department of Psychiatry, University of Cambridge, United Kingdom; Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil. Electronic address: linda.scoriels@inserm.fr.'}, {'ForeName': 'Larissa T', 'Initials': 'LT', 'LastName': 'Genaro', 'Affiliation': 'Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Keffer', 'Affiliation': 'Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Anna Luiza', 'Initials': 'AL', 'LastName': 'Guimarães', 'Affiliation': 'Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'Barros-Dumas', 'Affiliation': 'Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Luana G', 'Initials': 'LG', 'LastName': 'Mororó', 'Affiliation': 'Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Thales', 'Initials': 'T', 'LastName': 'Biagioni', 'Affiliation': 'Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Lucena', 'Affiliation': 'Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Thaís R', 'Initials': 'TR', 'LastName': 'da Hora', 'Affiliation': 'Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Sahakian', 'Affiliation': 'Department of Psychiatry, University of Cambridge, United Kingdom.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry, University of Minnesota, United States.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'Department of Psychiatry, University of Minnesota, United States.'}, {'ForeName': 'Rogério', 'Initials': 'R', 'LastName': 'Panizzutti', 'Affiliation': 'Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas, Universidade Federal do Rio de Janeiro, Brazil. Electronic address: rogerio@icb.ufrj.br.'}]",Schizophrenia research,['10.1016/j.schres.2022.02.013']
2201,35182889,Somatosensory amplification moderates the efficacy of internet-delivered CBT for somatic symptom distress in emerging adults: Exploratory analysis of a randomized controlled trial.,"OBJECTIVE


While studies mainly provide positive evidence for the efficacy of internet-delivered cognitive-behavioral therapy (ICBT) for various persistent somatic symptoms, it remains largely unclear for whom these interventions work or not. This exploratory analysis aimed to identify moderators for the outcome between ICBT for somatic symptom distres and a waitlist control group (WL) in a vulnerable target group of emerging adults.
METHODS


Based on data from a randomized controlled trial on 156 university students with varying degrees of somatic symptom distress who were allocated to either an eight-week, therapist guided ICBT (iSOMA) or to the WL, we examined pretreatment demographic characteristics, health-related variables (e.g., somatic symptom duration), mental distress (e.g., depression, anxiety) and cognitive-emotional factors (emotional reactivity, somatosensory amplification) as candidate moderators of the outcome, somatic symptom distress (assessed by the Patient Health Questionnaire, PHQ-15) from pre- to posttreatment.
RESULTS


Somatosensory amplification (assessed by the Somatosensory Amplification Scale, SSAS) moderated the outcome in favor of iSOMA (B = -0.17, SE = 0.08, p = 0.031), i.e., higher pretreatment somatosensory amplification was associated with better outcome in the active compared to the control intervention. No significant moderation effects were found among demographic characteristics, health-related variables, or mental distress.
CONCLUSION


Our findings suggest that an internet-delivered CBT for somatic symptom distress should be preferred over no active treatment particularly in individuals with moderate to high levels of somatosensory amplification, which as a next step should be tested against further treatments and in clinical populations.
TRIAL REGISTRATION


German Clinical Trials Register (DRKS00014375).",2022,"RESULTS


Somatosensory amplification (assessed by the Somatosensory Amplification Scale, SSAS) moderated the outcome in favor of iSOMA (B = -0.17, SE = 0.08, p = 0.031), i.e., higher pretreatment somatosensory amplification was associated with better outcome in the active compared to the control intervention.","['156 university students with varying degrees of somatic symptom distress', 'somatic symptom distres and a waitlist control group (WL) in a vulnerable target group of emerging adults', 'somatic symptom distress in emerging adults']","['internet-delivered cognitive-behavioral therapy (ICBT', 'internet-delivered CBT', 'therapist guided ICBT (iSOMA']","['somatic symptom duration), mental distress (e.g., depression, anxiety) and cognitive-emotional factors (emotional reactivity, somatosensory amplification) as candidate moderators of the outcome, somatic symptom distress', 'demographic characteristics, health-related variables, or mental distress']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0235109', 'cui_str': 'Mental distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",156.0,0.195649,"RESULTS


Somatosensory amplification (assessed by the Somatosensory Amplification Scale, SSAS) moderated the outcome in favor of iSOMA (B = -0.17, SE = 0.08, p = 0.031), i.e., higher pretreatment somatosensory amplification was associated with better outcome in the active compared to the control intervention.","[{'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Hennemann', 'Affiliation': 'Johannes Gutenberg University Mainz, Department of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Mainz, Germany. Electronic address: s.hennemann@uni-mainz.de.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Witthöft', 'Affiliation': 'Johannes Gutenberg University Mainz, Department of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Mainz, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kleinstäuber', 'Affiliation': 'Utah State University, Emma Eccles Jones College of Education and Human Services, Department of Psychology, Logan (Utah), USA.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Böhme', 'Affiliation': 'Johannes Gutenberg University Mainz, Department of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Mainz, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Ulm University, Department of Clinical Psychology and Psychotherapy, Ulm, Germany.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Technical University of Munich, Department of Sport and Health Sciences, München, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Probst', 'Affiliation': 'Danube University Krems, Department for Psychotherapy and Biopsychosocial Health, Krems, Austria.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2022.110761']
2202,35183806,"Influence of the end inspiratory pause on respiratory mechanics and tidal gas distribution of surgical patients ventilated under a tailored open lung approach strategy: A randomised, crossover trial.","BACKGROUND


The effect of modifying the end inspiratory pause (EIP) on respiratory mechanics and gas distribution of surgical patients ventilated with an open lung approach (OLA) has not been addressed before.
METHODS


Prospective, randomised, crossover study carried out in a tertiary hospital. Subjects were assigned to receive an initial EIP of 10% or 30% of the total inspiratory time. We compared standard ventilation [time 0: tidal volume (V T ) 7 mL × kg -1 , respiratory rate (RR) 13, inspiratory:expiratory (I:E) rate 1:2, positive end-expiratory pressure (PEEP) 5 cm H 2 O and EIP 10% and 30% for groups 1 and 2, respectively) with tailored OLA (similar parameters except for a tailored PEEP after a stepwise recruitment manoeuvre), followed by a crossover assignment sequence between groups (times 2-4).
RESULTS


We included 32 adult subjects undergoing major surgery. Tailored OLA strategy was associated with a significant increase in PEEP, plateau pressure (P plat ), PaO 2 , and compliance of the respiratory system (C RS ) with a significant decrease in driving pressure (P driv ) and PaCO 2 , and a more homogeneous gas distribution in both groups. A significantly lower PEEP (p < 0.001), P driv  (5 [5-6] versus 6.5 [6-8] cmH 2 O; p < 0.001) and mean airway pressure (P mean ; p <  0.001) together with a higher C RS  (77 [67-87] versus 58 [52-70] ml*cmH 2 O -1 ; p < 0.001) were observed when an EIP of 30% was applied as compared to an EIP of 10%.
CONCLUSION


The use of a tailored OLA strategy combined with a longer EIP is associated with a higher C RS,  and a lower P driv , P mean  and PEEP. Additional studies are necessary to assess if the improved ventilatory conditions observed with a longer EIP are associated with better patients' outcomes. Trial registration at clinicaltrials.gov with identifier: NCT03568786.",2022,"A significantly lower PEEP (p < 0.001), P driv  (5 [5-6] versus 6.5 [6-8] cmH 2 O; p < 0.001) and mean airway pressure (P mean ; p <  0.001) together with a higher C RS  (77 [67-87] versus 58","['52-70', 'surgical patients ventilated under a tailored open lung approach strategy', '32 adult subjects undergoing major surgery', 'surgical patients ventilated with an open lung approach (OLA']",['end inspiratory pause (EIP'],"['mean airway pressure', 'PEEP, plateau pressure (P plat ), PaO 2 , and compliance of the respiratory system (C RS ', 'respiratory mechanics and tidal gas distribution', 'PEEP', 'positive end-expiratory pressure (PEEP) 5', 'standard ventilation [time 0: tidal volume (V T ) 7\u2009mL*kg- 1 , respiratory rate (RR) 13, inspiratory', 'driving pressure']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0445176', 'cui_str': 'Plateau pressure'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",32.0,0.179235,"A significantly lower PEEP (p < 0.001), P driv  (5 [5-6] versus 6.5 [6-8] cmH 2 O; p < 0.001) and mean airway pressure (P mean ; p <  0.001) together with a higher C RS  (77 [67-87] versus 58","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'López-Herrera', 'Affiliation': 'Servicio de Anestesiología, Unidad de Gestión Clínica Bloque Quirúrgico, Hospital General, Hospital Universitario Virgen del Rocío, Sevilla, Spain. Electronic address: dalohero@gmail.com.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'De La Matta', 'Affiliation': 'Servicio de Anestesiología, Unidad de Gestión Clínica Bloque Quirúrgico, Hospital General, Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2022.101038']
2203,35184228,"Pharmacokinetic and subjective assessment of prototype JUUL2 electronic nicotine delivery system in two nicotine concentrations, JUUL system, IQOS, and combustible cigarette.","RATIONALE


Electronic nicotine delivery systems and heated tobacco products are noncombustible alternatives for adult smokers. Evidence suggests sufficient nicotine delivery and satisfying effects are necessary to facilitate switching away from smoking; nicotine delivery varies across electronic nicotine delivery systems within limited nicotine concentrations.
OBJECTIVES


To assess the nicotine delivery and subjective effects of prototype JUUL2 System in two nicotine concentrations, currently-marketed US JUUL System (""JUUL""), IQOS-brand heated tobacco product, and combustible cigarettes.
METHODS


Adult smokers (N = 40) completed a 5-arm cross-over product-use laboratory confinement study. Nicotine pharmacokinetics and subjective effects were assessed following use of: (1) JUUL2 prototype 18 mg/mL nicotine; (2) JUUL2 prototype 40 mg/mL; (3) JUUL 59 mg/mL; (4) IQOS 18 mg/g; and (5) usual brand combustible cigarette, each evaluated during ad libitum (10 min) and controlled (5 min, 10 standardized puffs) use.
RESULTS


Nicotine delivery was greatest for combustible cigarettes, followed by JUUL2 prototype 40 mg/mL, IQOS, JUUL2 prototype 18 mg/mL, and JUUL 59 mg/mL. Nicotine delivery from JUUL2 prototype 18 mg/mL was significantly greater than JUUL 59 mg/mL after ad libitum use. JUUL products were significantly more satisfying and effective at reducing craving than IQOS. JUUL2 prototype 40 mg/mL was significantly more aversive than other JUUL products.
CONCLUSIONS


Prototype JUUL2 and JUUL 59 mg/mL products were rated higher than IQOS on subjective measures associated with switching away from smoking. The JUUL2 prototype 40 mg/mL produced aversive responses and would require modifications to be a viable product for adult smokers. Nicotine delivery and subjective responses to JUUL2 prototype 18 mg/mL suggest a product based on this prototype may facilitate increased switching among adult smokers.",2022,"RESULTS


Nicotine delivery was greatest for combustible cigarettes, followed by JUUL2 prototype 40 mg/mL, IQOS, JUUL2","['IQOS 18', 'Adult smokers (N\u2009=\u200940) completed a 5-arm cross-over product-use laboratory confinement study', 'adult smokers']","['Nicotine', 'JUUL2 prototype 40', 'JUUL2', 'Prototype JUUL2 and JUUL', 'prototype 18\xa0mg/mL, and JUUL 59\xa0mg/mL. Nicotine', 'JUUL2 prototype 18\xa0mg/mL nicotine; (2) JUUL2']","['aversive responses', 'Nicotine pharmacokinetics and subjective effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439294', 'cui_str': 'g/L'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.105628,"RESULTS


Nicotine delivery was greatest for combustible cigarettes, followed by JUUL2 prototype 40 mg/mL, IQOS, JUUL2","[{'ForeName': 'Nicholas I', 'Initials': 'NI', 'LastName': 'Goldenson', 'Affiliation': 'Juul Labs, Inc, 1000 F Street NW, Suite 800, Washington, D.C, 20004, USA. nicholas.goldenson@juul.com.'}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'Augustson', 'Affiliation': 'Juul Labs, Inc, 1000 F Street NW, Suite 800, Washington, D.C, 20004, USA.'}, {'ForeName': 'Joey', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Juul Labs, Inc, 1000 F Street NW, Suite 800, Washington, D.C, 20004, USA.'}, {'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Shiffman', 'Affiliation': 'Pinney Associates, Inc, Pittsburgh, PA, USA.'}]",Psychopharmacology,['10.1007/s00213-022-06100-0']
2204,35188555,Time to Functional Recovery After Laser Tonsillotomy Performed Under Local Anesthesia vs Conventional Tonsillectomy With General Anesthesia Among Adults: A Randomized Clinical Trial.,"Importance


Carbon dioxide laser tonsillotomy performed under local anesthesia may be an effective and less invasive alternative than dissection tonsillectomy for treatment of tonsil-related afflictions.
Objective


To compare functional recovery and symptom relief among adults undergoing tonsillectomy or tonsillotomy.
Design, Setting, and Participants


This randomized clinical trial was conducted at 5 secondary and tertiary hospitals in the Netherlands from January 2018 to December 2019. Participants were 199 adult patients with an indication for surgical tonsil removal randomly assigned to either the tonsillectomy or tonsillotomy group.
Interventions


For tonsillotomy, the crypts of the palatine tonsil were evaporated using a carbon dioxide laser under local anesthesia, whereas tonsillectomy consisted of total tonsil removal performed under general anesthesia.
Main Outcomes and Measures


The primary outcome was time to functional recovery measured within 2 weeks after surgery assessed for a modified intention-to-treat population. Secondary outcomes were time to return to work after surgery, resolution of primary symptoms, severity of remaining symptoms, surgical complications, postoperative pain and analgesics use, and overall patient satisfaction assessed for the intention-to-treat population.
Results


Of 199 patients (139 [70%] female; mean [SD] age, 29 [9] years), 98 were randomly assigned to tonsillotomy and 101 were randomly assigned to tonsillectomy. Recovery within 2 weeks after surgery was significantly shorter after tonsillotomy than after tonsillectomy (hazard ratio for recovery after tonsillectomy vs tonsillotomy, 0.3; 95% CI, 0.2-0.5). Two weeks after surgery, 72 (77%) patients in the tonsillotomy group were fully recovered compared with 26 (57%) patients in the tonsillectomy group. Time until return to work within 2 weeks was also shorter after tonsillotomy (median [IQR], 4.5 [3.0-7.0] days vs 12.0 [9.0-14.0] days; hazard ratio for return after tonsillectomy vs tonsillotomy, 0.3; 95% CI, 0.2-0.4.). Postoperative hemorrhage occurred in 2 patients (2%) in the tonsillotomy group and 8 patients (12%) in the tonsillectomy group. At 6 months after surgery, fewer patients in the tonsillectomy group (25; 35%) than in the tonsillotomy group (54; 57%) experienced persistent symptoms (difference of 22%; 95% CI, 7%-37%). Most patients with persistent symptoms in both the tonsillotomy (32 of 54; 59%) and tonsillectomy (16 of 25; 64%) groups reported mild symptoms 6 months after surgery.
Conclusions and Relevance


This randomized clinical trial found that compared with tonsillectomy performed under general anesthesia, laser tonsillotomy performed under local anesthesia had a significantly shorter and less painful recovery period. A higher percentage of patients had persistent symptoms after tonsillotomy, although the intensity of these symptoms was lower than before surgery. These results suggest that laser tonsillotomy performed under local anesthesia may be a feasible alternative to conventional tonsillectomy in this population.
Trial Registration


Netherlands Trial Register Identifier: NL6866 (NTR7044).",2022,"Recovery within 2 weeks after surgery was significantly shorter after tonsillotomy than after tonsillectomy (hazard ratio for recovery after tonsillectomy vs tonsillotomy, 0.3; 95% CI, 0.2-0.5).","['adults undergoing tonsillectomy or tonsillotomy', ' mean [SD] age, 29 [9] years', 'Participants were 199 adult patients with an indication for surgical tonsil removal randomly assigned to either the', 'Adults', '5 secondary and tertiary hospitals in the Netherlands from January 2018 to December 2019', '199 patients (139 [70%] female']","['Laser Tonsillotomy Performed Under Local Anesthesia vs Conventional Tonsillectomy', 'tonsillectomy', 'tonsillectomy or tonsillotomy group', 'carbon dioxide laser under local anesthesia, whereas tonsillectomy consisted of total tonsil removal performed under general anesthesia', 'Carbon dioxide laser tonsillotomy']","['time to functional recovery', 'Postoperative hemorrhage', 'time to return to work after surgery, resolution of primary symptoms, severity of remaining symptoms, surgical complications, postoperative pain and analgesics use, and overall patient satisfaction assessed for the intention-to-treat population', 'persistent symptoms', 'functional recovery and symptom relief', 'Time to Functional Recovery']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0193930', 'cui_str': 'Incision of tonsil'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0040421', 'cui_str': 'Tonsillar structure (palatine)'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0193930', 'cui_str': 'Incision of tonsil'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040421', 'cui_str': 'Tonsillar structure (palatine)'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",199.0,0.284737,"Recovery within 2 weeks after surgery was significantly shorter after tonsillotomy than after tonsillectomy (hazard ratio for recovery after tonsillectomy vs tonsillotomy, 0.3; 95% CI, 0.2-0.5).","[{'ForeName': 'Justin E R E', 'Initials': 'JERE', 'LastName': 'Wong Chung', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Hagaziekenhuis, The Hague, the Netherlands.'}, {'ForeName': 'Rozemarie', 'Initials': 'R', 'LastName': 'van Geet', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Hagaziekenhuis, The Hague, the Netherlands.'}, {'ForeName': 'Noud', 'Initials': 'N', 'LastName': 'van Helmond', 'Affiliation': 'Department of Anesthesiology, Cooper University Medical School of Rowan University, Cooper University Health Care, Camden, New Jersey.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Kastoer', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Hagaziekenhuis, The Hague, the Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Böhringer', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Wilbert B', 'Initials': 'WB', 'LastName': 'van den Hout', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Hendrik P', 'Initials': 'HP', 'LastName': 'Verschuur', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Haaglanden Medical Center, The Hague, the Netherlands.'}, {'ForeName': 'Ferdinand A W', 'Initials': 'FAW', 'LastName': 'Peek', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Reinier de Graaf, Delft, the Netherlands.'}, {'ForeName': 'Patrick F M', 'Initials': 'PFM', 'LastName': 'Dammeijer', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, VieCuri Medical Center, Venlo, the Netherlands.'}, {'ForeName': 'Gijs K A', 'Initials': 'GKA', 'LastName': 'van Wermeskerken', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Peter Paul G', 'Initials': 'PPG', 'LastName': 'van Benthem', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Henk M', 'Initials': 'HM', 'LastName': 'Blom', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Hagaziekenhuis, The Hague, the Netherlands.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.48655']
2205,35188554,Effect of Cancer Pain Guideline Implementation on Pain Outcomes Among Adult Outpatients With Cancer-Related Pain: A Stepped Wedge Cluster Randomized Trial.,"Importance


An evidence-practice gap exists for cancer pain management, and cancer pain remains prevalent and disabling.
Objectives


To evaluate the capacity of 3 cancer pain guideline implementation strategies to improve pain-related outcomes for patients attending oncology and palliative care outpatient services.
Design, Setting, and Participants


A pragmatic, stepped wedge, cluster-randomized, nonblinded, clinical trial was conducted between 2014 and 2019. The clusters were cancer centers in Australia providing oncology and palliative care outpatient clinics. Participants included a consecutive cohort of adult outpatients with advanced cancer and a worst pain severity score of 2 or more out of 10 on a numeric rating scale (NRS). Data were collected between August 2015 and May 2019. Data were analyzed July to October 2019 and reanalyzed November to December 2021.
Interventions


Guideline implementation strategies at the cluster, health professional, and patient levels introduced with the support of a clinical champion.
Main Outcomes and Measures


The primary measure of effect was the percentage of participants initially screened as having moderate to severe worst pain (NRS ≥ 5) who experienced a clinically important improvement of 30% or more 1 week later. Secondary outcomes included mean average pain, patient empowerment, fidelity to the intervention, and quality of life and were measured in all participants with a pain score of 2 or more 10 at weeks 1, 2, and 4.
Results


Of 8099 patients screened at 6 clusters, 1564 were eligible, and 359 were recruited during the control phase (mean [SD] age, 64.2 [12.1] years; 196 men [55%]) and 329 during the intervention phase (mean [SD] age, 63.6 [12.7] years; 155 men [47%]), with no significant differences between phases on baseline measures. The mean (SD) baseline worst pain scores were 5.0 (2.6) and 4.9 (2.6) for control and intervention phases, respectively. The mean (SD) baseline average pain scores were 3.5 (2.1) for both groups. For the primary outcome, the proportions of participants with a 30% or greater reduction in a pain score of 5 or more of 10 at baseline were similar in the control and intervention phases (31 of 280 participants [11.9%] vs 30 of 264 participants [11.8%]; OR, 1.12; 95% CI, 0.79-1.60; P = .51). No significant differences were found in secondary outcomes between phases. Fidelity to the intervention was low.
Conclusions and Relevance


A suite of implementation strategies was insufficient to improve pain-related outcomes for outpatients with cancer-related pain. Further evaluation is needed to determine the required clinical resources needed to enable wide-scale uptake of the fundamental elements of cancer pain care. Ongoing quality improvement activities should be supported to improve sustainability.",2022,No significant differences were found in secondary outcomes between phases.,"['outpatients with cancer-related pain', 'Participants included a consecutive cohort of adult outpatients with advanced cancer and a worst pain severity score of 2 or more out of 10 on a numeric rating scale (NRS', 'patients attending oncology and palliative care outpatient services', 'clusters were cancer centers in Australia providing oncology and palliative care outpatient clinics', '8099 patients screened at 6 clusters', '1564 were eligible, and 359 were recruited during the control phase (mean [SD] age, 64.2 [12.1] years; 196 men [55%]) and 329 during the intervention phase (mean [SD] age, 63.6 [12.7] years; 155 men [47', 'Adult Outpatients With Cancer-Related Pain']",['Cancer Pain Guideline Implementation'],"['mean (SD) baseline average pain scores', 'Pain Outcomes', 'mean (SD) baseline worst pain scores', 'pain score', 'mean average pain, patient empowerment, fidelity to the intervention, and quality of life']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0086751', 'cui_str': 'Outpatient service'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517546', 'cui_str': '12.7'}]","[{'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C3853035', 'cui_str': 'Patient Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.605792,No significant differences were found in secondary outcomes between phases.,"[{'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Lovell', 'Affiliation': 'Palliative Care Department, HammondCare, Greenwich, Australia.'}, {'ForeName': 'Jane L', 'Initials': 'JL', 'LastName': 'Phillips', 'Affiliation': 'IMPACCT Centre-Improving Palliative, Aged and Chronic Care through Clinical Research and Translation University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Luckett', 'Affiliation': 'IMPACCT Centre-Improving Palliative, Aged and Chronic Care through Clinical Research and Translation University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lam', 'Affiliation': 'IMPACCT Centre-Improving Palliative, Aged and Chronic Care through Clinical Research and Translation University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Frances M', 'Initials': 'FM', 'LastName': 'Boyle', 'Affiliation': 'Patricia Ritchie Centre for Cancer Care and Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Davidson', 'Affiliation': 'IMPACCT Centre-Improving Palliative, Aged and Chronic Care through Clinical Research and Translation University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Seong L', 'Initials': 'SL', 'LastName': 'Cheah', 'Affiliation': 'IMPACCT Centre-Improving Palliative, Aged and Chronic Care through Clinical Research and Translation University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'McCaffrey', 'Affiliation': 'Deakin University, Geelong, Deakin Health Economics, Institute for Health Transformation, School of Health and Social Development, Victoria, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'IMPACCT Centre-Improving Palliative, Aged and Chronic Care through Clinical Research and Translation University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Shaw', 'Affiliation': 'University of Sydney, Sydney, Australia.'}, {'ForeName': 'Annmarie', 'Initials': 'A', 'LastName': 'Hosie', 'Affiliation': ""The University of Notre Dame Australia, School of Nursing Sydney and St Vincent's Health Network Sydney, Sydney, Australia.""}, {'ForeName': 'Bogda', 'Initials': 'B', 'LastName': 'Koczwara', 'Affiliation': 'Flinders Medical Centre and Flinders University, Adelaide, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Clarke', 'Affiliation': 'Northern Clinical School, Sydney Medical School, Sydney, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'IMPACCT Centre-Improving Palliative, Aged and Chronic Care through Clinical Research and Translation University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Stockler', 'Affiliation': 'Concord Centre for Palliative Care, Concord Repatriation General Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Sheehan', 'Affiliation': 'Palliative Care Department, South East Sydney Local Health District, Southern Sector, Sydney Australia.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Spruijt', 'Affiliation': 'Palliative Care Department, Western Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Allsopp', 'Affiliation': 'Palliative Care Department, Westmead Hospital, Westmead, Sydney, Australia.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Clinch', 'Affiliation': 'Department of Palliative Care, Peter Macallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': 'Northern Clinical School, Sydney Medical School, Sydney, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Read', 'Affiliation': 'IMPACCT Centre-Improving Palliative, Aged and Chronic Care through Clinical Research and Translation University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Agar', 'Affiliation': 'IMPACCT Centre-Improving Palliative, Aged and Chronic Care through Clinical Research and Translation University of Technology Sydney, Sydney, Australia.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.0060']
2206,35188552,Comparison of 3 Paclitaxel-Based Chemoradiotherapy Regimens for Patients With Locally Advanced Esophageal Squamous Cell Cancer: A Randomized Clinical Trial.,"Importance


Multiple paclitaxel-based regimens are widely used in chemoradiation therapy against esophageal cancer, including regimens combining paclitaxel with fluorouracil, cisplatin, and carboplatin. However, which among these 3 regimens provides the best prognosis with minimum adverse events is still unknown.
Objective


To compare the efficacy and adverse events of fluorouracil, cisplatin, and carboplatin in definitive chemoradiotherapy in patients with esophageal squamous cell carcinoma (ESCC).
Design, Setting, and Participants


This randomized clinical trial of patients with ESCC was conducted in 11 treatment centers in China. Eligible patients were aged 18 to 75 years and had histologically confirmed ESCC stages IIa to IVa with no prior treatment, Eastern Cooperative Oncology Group performance status of 2 or lower, and adequate organ functions. The study was conducted between July 2015 and February 2018, and the cutoff date for data analysis was August 31, 2020.
Interventions


Patients with locally advanced ESCC were randomly assigned (1:1:1) to groups combining paclitaxel treatment with fluorouracil, cisplatin, or carboplatin. Patients in the cisplatin group were treated with 2 cycles of concurrent chemoradiotherapy followed by 2 cycles of consolidation chemotherapy with monthly paclitaxel plus cisplatin. For the fluorouracil group, patients were administered 6 cycles of weekly paclitaxel plus fluorouracil in concurrent chemoradiotherapy followed by 2 cycles of monthly paclitaxel plus fluorouracil in consolidation chemotherapy. Patients in the carboplatin group were treated with 6 cycles of weekly paclitaxel plus carboplatin in concurrent chemoradiotherapy followed by 2 cycles of monthly paclitaxel plus carboplatin in consolidation chemotherapy. All patients received radiotherapy of 61.2 Gy delivered in 34 fractions.
Main Outcomes and Measures


The primary end point was overall survival (OS). The secondary end points were progression-free survival and adverse events.
Results


Overall, 321 patients (median [IQR] age, 64 years [59-69 years]; 248 [77.3%] men) with ESCC from 11 centers were randomized into fluorouracil, cisplatin, or carboplatin groups between July 2015 and February 2018. Over a median (IQR) follow-up time of surviving patients of 46.0 months (36.6-53.0 months), the 3-year OS rates were 57.2% in the fluorouracil group, 60.1% in the cisplatin group, and 56.5% in the carboplatin group, respectively (fluorouracil vs cisplatin: HR, 1.06; 95% CI, 0.71-1.60; P = .77; fluorouracil vs carboplatin: HR, 0.94; 95% CI, 0.63-1.40; P = .77). The cisplatin group had significantly higher incidences of acute grade 3 or 4 neutropenia (69 events [60.8%] vs 19 [17.8%] for fluorouracil and 37 [34.6%] carboplatin; P < .001), thrombocytopenia (14 events [13.1%] vs 4 [3.7%] for fluorouracil and 5 [4.7%] for carboplatin; P = .01), anemia (50 events above grade 2 [46.7%] vs 25 [23.4%] for fluorouracil and 37 [34.6%] for carboplatin; P = .35), fatigue (11 events [10.3%] vs 2 [1.9%] for fluorouracil and 1 [0.9%] carboplatin; P = .007), and vomiting (17 events above grade 2 [15.9%] vs 3 [2.8%] for fluorouracil and 5 [4.7%] for carboplatin; P < .001) than the other 2 groups.
Conclusions and Relevance


In this randomized clinical trial, paclitaxel plus fluorouracil did not show OS superiority over paclitaxel plus cisplatin or paclitaxel plus carboplatin regimens in definitive chemoradiation in patients with locally advanced ESCC. Higher rates of hematologic and gastrointestinal toxic effects were reported in the cisplatin group compared with those in the fluorouracil or carboplatin groups.
Trial Registration


ClinicalTrials.gov Identifier: NCT02459457.",2022,"Higher rates of hematologic and gastrointestinal toxic effects were reported in the cisplatin group compared with those in the fluorouracil or carboplatin groups.
","['patients with locally advanced ESCC', 'Eligible patients were aged 18 to 75 years and had histologically confirmed ESCC stages IIa to IVa with no prior treatment, Eastern Cooperative Oncology Group performance status of 2 or lower, and adequate organ functions', 'groups between July 2015 and February 2018', 'Patients With Locally Advanced Esophageal Squamous Cell Cancer', 'July 2015 and February 2018, and the cutoff date for data analysis was August 31, 2020', '321 patients (median [IQR] age, 64 years [59-69 years]; 248 [77.3%] men) with ESCC from 11 centers', 'patients with ESCC was conducted in 11 treatment centers in China', 'Interventions\n\n\nPatients with locally advanced ESCC', 'patients with esophageal squamous cell carcinoma (ESCC']","['fluorouracil or carboplatin', 'paclitaxel with fluorouracil, cisplatin, and carboplatin', 'paclitaxel treatment with fluorouracil, cisplatin, or carboplatin', 'fluorouracil', 'paclitaxel plus fluorouracil', 'paclitaxel plus cisplatin or paclitaxel plus carboplatin regimens', 'paclitaxel plus carboplatin', 'fluorouracil vs cisplatin', 'concurrent chemoradiotherapy', 'fluorouracil, cisplatin, and carboplatin', 'carboplatin', 'radiotherapy', 'Paclitaxel-Based Chemoradiotherapy Regimens', 'fluorouracil, cisplatin, or carboplatin', 'cisplatin', 'consolidation chemotherapy with monthly paclitaxel plus cisplatin']","['overall survival (OS', 'anemia ', 'hematologic and gastrointestinal toxic effects', 'vomiting', 'fatigue', 'progression-free survival and adverse events', 'acute grade 3 or 4 neutropenia', '3-year OS rates', 'thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",,0.144046,"Higher rates of hematologic and gastrointestinal toxic effects were reported in the cisplatin group compared with those in the fluorouracil or carboplatin groups.
","[{'ForeName': 'Dashan', 'Initials': 'D', 'LastName': 'Ai', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jinjun', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Radiation Oncology, Jiangsu Cancer Hospital, Jiangsu Institute Of Cancer Research, Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Shihong', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'Department of Radiation Oncology, Gansu Province Cancer Hospital, Lanzhou, China.'}, {'ForeName': 'Yunhai', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center Minhang Branch Hospital, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Radiation Oncology, Jiangxi Province Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Radiation Oncology, Shanxi Province Cancer Hospital, Taiyuan, China.'}, {'ForeName': 'Zhengfei', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Weixin', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, First Affiliated Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Huanjun', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xiangpeng', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Radiation Oncology, Huadong Hospital Affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Jialiang', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiation Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Department of Radiation Oncology, Hainan Province People's Hospital, Haikou, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jiancheng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Fujian Province Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Jiangsu Cancer Hospital, Jiangsu Institute Of Cancer Research, Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Guoren', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Department of Internal Medicine, Jiangsu Cancer Hospital, Jiangsu Institute Of Cancer Research, Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dayong', 'Initials': 'D', 'LastName': 'Gu', 'Affiliation': 'Department of Radiation Oncology, Jiangsu Cancer Hospital, Jiangsu Institute Of Cancer Research, Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Mingyu', 'Initials': 'M', 'LastName': 'Du', 'Affiliation': 'Department of Radiation Oncology, Jiangsu Cancer Hospital, Jiangsu Institute Of Cancer Research, Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': 'Department of Cancer Prevention & Clinical Statistics Center, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'HuiXun', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Shanghai General Hospital, Shanghai, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Kuaile', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.0120']
2207,35189696,Sex-Based Differences in Revascularization Outcomes: Is It Time for a Dedicated Randomized Trial in Women?,,2022,,[],[],[],[],[],[],,0.131866,,"[{'ForeName': 'Waqas A', 'Initials': 'WA', 'LastName': 'Malick', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai New York NY.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Soriano', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai New York NY.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai New York NY.'}]",Journal of the American Heart Association,['10.1161/JAHA.121.024281']
2208,35190317,Adaptive treadmill walking encourages persistent propulsion.,"BACKGROUND


Adaptive treadmills allow real-time changes in walking speed by responding to changes in step length, propulsion, or position on the treadmill. The stride-to-stride variability, or persistence, of stride time during overground, fixed-speed, and adaptive treadmill walking has been studied, but persistence of propulsion during adaptive treadmill walking remains unknown. Because increased propulsion is often a goal of post-stroke rehabilitation, knowledge of the stride-to-stride variability may aid rehabilitation protocol design.
RESEARCH QUESTION


How do spatiotemporal and propulsive gait variables vary from stride to stride during adaptive treadmill walking, and how do they compare to fixed-speed treadmill walking?
METHODS


Eighteen young healthy subjects walked on an instrumented split-belt treadmill in the adaptive and fixed-speed modes for 10 minutes at their comfortable speed. Kinetic data was collected from the treadmill. Detrended fluctuation analysis was applied to the time series data. Shapiro-Wilk tests assessed normality and one-way repeated measures ANOVAs compared between adaptive, fixed-speed, and randomly shuffled conditions at a Bonferroni-corrected significance level of 0.0055.
RESULTS


Stride time, stride length, step length, and braking impulse were persistent (α > 0.5) in the adaptive and fixed-speed conditions. Adaptive and fixed-speed were different from each other. Stride speed was persistent in the adaptive condition and anti-persistent (α < 0.5) in the fixed-speed condition. Peak propulsive force, peak braking force, and propulsive impulse were persistent in the adaptive condition but not the fixed-speed condition (α ≈ 0.5). Net impulse was non-persistent in the adaptive and fixed-speed conditions. All variables were non-persistent in the shuffled condition.
SIGNIFICANCE


During adaptive treadmill walking, increases in propulsive force and impulse persist for multiple strides. Persistence was stronger on the adaptive treadmill, where increased propulsion translates into increased walking speed. For post-stroke gait rehabilitation where increasing propulsion and speed are goals, the stronger persistence of adaptive treadmill walking may be beneficial.",2022,"Peak propulsive force, peak braking force, and propulsive impulse were persistent in the adaptive condition but not the fixed-speed condition (α ≈ 0.5).",['Eighteen young healthy subjects walked on an'],"['Adaptive treadmill walking encourages persistent propulsion', 'instrumented split-belt treadmill in the adaptive and fixed-speed modes for 10\xa0minutes at their comfortable speed']","['Adaptive and fixed-speed', 'Stride speed', 'Peak propulsive force, peak braking force, and propulsive impulse', 'propulsion translates into increased walking speed', 'adaptive condition and anti-persistent (α', 'stride-to-stride variability, or persistence, of stride time during overground, fixed-speed, and adaptive treadmill walking', 'Stride time, stride length, step length, and braking impulse']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C3653283', 'cui_str': 'PROPULSIVES'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0040710', 'cui_str': 'Translating'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0427126', 'cui_str': 'Step length'}]",18.0,0.0278124,"Peak propulsive force, peak braking force, and propulsive impulse were persistent in the adaptive condition but not the fixed-speed condition (α ≈ 0.5).","[{'ForeName': 'Margo C', 'Initials': 'MC', 'LastName': 'Donlin', 'Affiliation': 'Department of Biomedical Engineering, University of Delaware, Newark, DE, USA. Electronic address: donlinm@udel.edu.'}, {'ForeName': 'Kayla M', 'Initials': 'KM', 'LastName': 'Pariser', 'Affiliation': 'Department of Mechanical Engineering, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Kaitlyn E', 'Initials': 'KE', 'LastName': 'Downer', 'Affiliation': 'Department of Mechanical Engineering, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Jill S', 'Initials': 'JS', 'LastName': 'Higginson', 'Affiliation': 'Department of Biomedical Engineering, University of Delaware, Newark, DE, USA; Department of Mechanical Engineering, University of Delaware, Newark, DE, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2022.02.017']
2209,35190316,Static and dynamic postural control of postpartum women of different delivery methods.,"OBJECTIVE


The aim of this study was to determine whether there is a difference in postural control between nulligravida women and women who have given birth by vaginal or cesarean section.
METHODS


Women who had only vaginal delivery in the previous 1-3 years were included in the vaginal delivery group (n = 27), those who had only cesarean delivery in the previous 1-3 years were included in the cesarean section group (n = 28), and those who had never given birth were included in the control group (n = 32). Evaluations were administered 6-8 days after the ovulation phase. Postural control of the participants was evaluated with the computerized dynamic posturography device.
RESULTS


A total of 87 women with a mean age of 29.4 ± 4 years and a mean body mass index of 24.1 ± 3.1 kg/m 2  were included in the study. Antero-posterior somatosensory organization test values of the vaginal delivery group were lower than the control group (p = 0.0016). The cesarean delivery group had statistically lower antero-posterior somatosensory (p < 0.001 and p = 0.0013) and medio-lateral somatosensory (p = 0.002 and p = 0.017, respectively) test scores compared to the control group and the vaginal delivery group.
CONCLUSIONS


It was observed that women who birthed with vaginal or cesarean delivery had impaired somatosensory postural control. There is definitely a need for further studies with a long-term follow-up examining the effects of postural control during pregnancy and the postpartum period.",2022,Antero-posterior somatosensory organization test values of the vaginal delivery group were lower than the control group (p = 0.0016).,"['Women who had only vaginal delivery in the previous 1-3 years were included in the vaginal delivery group (n\xa0=\xa027), those who had only cesarean delivery in the previous 1-3 years were included in the cesarean section group (n\xa0=\xa028), and those who had never given birth were included in the control group (n\xa0=\xa032', '87 women with a mean age of 29.4\xa0±\xa04 years and a mean body mass index of 24.1\xa0±\xa03.1\xa0kg/m 2  were included in the study', 'postpartum women of different delivery methods', 'nulligravida women and women who have given birth by vaginal or cesarean section', 'women who birthed with vaginal or cesarean delivery had impaired somatosensory postural control']",['computerized dynamic posturography device'],"['medio-lateral somatosensory', 'antero-posterior somatosensory']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0232995', 'cui_str': 'Gravida 0'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]",87.0,0.0402745,Antero-posterior somatosensory organization test values of the vaginal delivery group were lower than the control group (p = 0.0016).,"[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Baran', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hitit University, Çorum, Turkey. Electronic address: eminekbaran@gmail.com.'}, {'ForeName': 'Tuğba', 'Initials': 'T', 'LastName': 'Emekci', 'Affiliation': 'Faculty of Medicine, Ear-Nose-Throat Clinic, Necmettin Erbakan University, Konya, Turkey. Electronic address: t.emekci@hotmail.com.'}]",Gait & posture,['10.1016/j.gaitpost.2022.02.007']
2210,35191384,"Comparison of pain severity, satisfaction, and complications of proximal and distal forearm anesthesia in patients undergoing trans-palmar coronary angiography.","OBJECTIVE


Trans-palmar access is a novel, safe, and feasible technique for coronary artery angiography wherein its appropriate anesthetic methods is still concerned. In this study, we aimed to evaluate the pain severity, satisfaction, and possible complications with local ulnar nerve anesthesia through both distal and proximal forearm in patients undergoing trans-palmar coronary angiography.
METHODS


This was a randomized clinical trial performed on 60 patients who were candidates for trans-palmar coronary angiography. The patients were randomized into 2 equal groups as proximal and distal approaches (those who received the same dose of subcutaneous lidocaine (2%) in the proximal and distal of forearm, respectively). Pain intensity at different times, duration of anesthesia, patient satisfaction, and occurrence of complications were evaluated.
RESULTS


The mean age of the patients was 59.45±7.09 years, and, of them, 34 (61.8%) were men. Pain severity with the proximal anesthesia approach was significantly higher than that in the distal group at the time of puncture (5.39±0.73 vs. 2.30±0.60, p=0.001). Over time and immediately after the procedure and at discharge, the mean pain severity in the proximal group was significantly less than in the distal group (p<0.050). The proximal group also had a longer duration of anesthesia (67.14±11.58) than the distal group (53.52±8.06) (p=0.001). No differences were observed in terms of patient satisfaction and complications (p>0.050).
CONCLUSION


Using the proximal ulnar nerve anesthesia approach was associated with a delayed onset and longer anesthesia than the distal method.",2022,The proximal group also had a longer duration of anesthesia (67.14±11.58) than the distal group (53.52±8.06) (p=0.001).,"['The mean age of the patients was 59.45±7.09 years, and, of them, 34 (61.8%) were men', '60 patients who were candidates for trans-palmar coronary angiography', 'patients undergoing trans-palmar coronary angiography']","['local ulnar nerve anesthesia through both distal and proximal forearm', 'subcutaneous lidocaine']","['patient satisfaction and complications', 'Pain intensity at different times, duration of anesthesia, patient satisfaction, and occurrence of complications', 'longer duration of anesthesia', 'pain severity, satisfaction', 'Pain severity', 'pain severity, satisfaction, and complications of proximal and distal forearm anesthesia', 'mean pain severity']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1184147', 'cui_str': 'Palmar'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0041602', 'cui_str': 'Structure of ulnar nerve'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",60.0,0.0659066,The proximal group also had a longer duration of anesthesia (67.14±11.58) than the distal group (53.52±8.06) (p=0.001).,"[{'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Roghani-Dehkordi', 'Affiliation': 'Departments of Cardiology, and Interventional Cardiology Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences; Isfahan-Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Farazandeh', 'Affiliation': 'Departments of Cardiology, andCardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences; Isfahan-Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kermani-Alghoraishi', 'Affiliation': 'Departments of Cardiology, and Interventional Cardiology Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences; Isfahan-Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Khosravi', 'Affiliation': 'Departments of Cardiology, and Hypertension Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences; Isfahan-Iran.'}]",Anatolian journal of cardiology,['10.5152/AnatolJCardiol.2021.282']
2211,34865002,Genetic polymorphism of Trypanosoma cruzi bloodstream populations in adult chronic indeterminate Chagas disease patients from the E1224 clinical trial.,"BACKGROUND


The role that the genetic diversity of natural Trypanosoma cruzi populations plays in response to trypanocidal treatment of chronic Chagas disease (CD) patients remains to be understood. We analysed the genetic polymorphisms of parasite bloodstream populations infecting chronic CD patients enrolled in the E1224 clinical trial.
METHODS


A total of 506 baseline and post-treatment follow-up samples from 188 patients were analysed. T. cruzi satellite DNA (satDNA) was amplified and sequenced using cruzi1/cruzi2 primers, and samples with TcI/III, TcII, TcIV or hybrid satDNA sequences were identified. Minicircle signatures were obtained after kinetoplast DNA amplification using 121/122 primers and restriction enzyme digestion. Genetic distances between baseline and post-treatment minicircle signatures were estimated using the Jaccard coefficient.
RESULTS


At baseline, 74.3% TcII, 17.9% hybrid and 7.8% TcI/III satDNA sequences were found, whereas at the end of follow-up the distribution was 55.2% TcII, 35.2% hybrid and 9.5% TcI/III. The placebo arm was the treatment group with the highest variation of satDNA sequences between baseline and post-treatment follow-up. Genetic distances between baseline and post-treatment minicircle signatures were similar among all treatment arms. No association between minicircle signature variability and satDNA type distribution was found.
CONCLUSIONS


Genetic variability of T. cruzi bloodstream populations during post-treatment follow-up did not differ from that observed during chronic infection in the absence of treatment, suggesting that there were no selection events of E1224-resistant parasite populations. This is the first report documenting the genetic polymorphism of natural T. cruzi populations in chronic patients in the context of clinical trials with trypanocidal drugs.",2022,"T. cruzi satellite DNA (satDNA) was amplified and sequenced using cruzi1/cruzi2 primers, and samples with TcI/III, TcII, TcIV or hybrid satDNA sequences were identified.","['parasite bloodstream populations infecting chronic CD patients enrolled in the E1224 clinical trial', 'adult chronic indeterminate Chagas disease patients from the E1224 clinical trial', 'A total of 506 baseline and post-treatment follow-up samples from 188 patients were analysed', 'chronic Chagas disease (CD) patients']",['placebo'],"['satDNA sequences', 'Genetic distances']","[{'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0343804', 'cui_str': ""Chronic Chagas' disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205258', 'cui_str': 'Indeterminate'}, {'cui': 'C0041234', 'cui_str': 'Infection by Trypanosoma cruzi'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012934', 'cui_str': 'Satellite DNA'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",188.0,0.212551,"T. cruzi satellite DNA (satDNA) was amplified and sequenced using cruzi1/cruzi2 primers, and samples with TcI/III, TcII, TcIV or hybrid satDNA sequences were identified.","[{'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Ramírez', 'Affiliation': 'Instituto de Investigaciones en Ingeniería Genética y Biología Molecular ""Dr. Héctor N. Torres"" (INGEBI-CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Gonzalo Raúl', 'Initials': 'GR', 'LastName': 'Acevedo', 'Affiliation': 'Instituto de Investigaciones en Ingeniería Genética y Biología Molecular ""Dr. Héctor N. Torres"" (INGEBI-CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Torres', 'Affiliation': 'Universidad de Buenos Aires, Instituto de Investigaciones en Bacteriología y Virología Molecular (IBaViM), Buenos Aires, Argentina.'}, {'ForeName': 'Rudy', 'Initials': 'R', 'LastName': 'Parrado', 'Affiliation': 'Instituto de Investigaciones Biomédicas (IIBISMED), Universidad Mayor de San Simón, Cochabamba, Bolivia.'}, {'ForeName': 'Anabelle', 'Initials': 'A', 'LastName': 'De La Barra', 'Affiliation': 'Instituto de Investigaciones Biomédicas (IIBISMED), Universidad Mayor de San Simón, Cochabamba, Bolivia.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Villarroel', 'Affiliation': 'Instituto de Investigaciones Biomédicas (IIBISMED), Universidad Mayor de San Simón, Cochabamba, Bolivia.'}, {'ForeName': 'Lineth', 'Initials': 'L', 'LastName': 'García', 'Affiliation': 'Instituto de Investigaciones Biomédicas (IIBISMED), Universidad Mayor de San Simón, Cochabamba, Bolivia.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Gascon', 'Affiliation': 'ISGlobal, Barcelona Centre for International Health Research (CRESIB), Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Ortiz', 'Affiliation': 'Universidad Autónoma Juan Misael Saracho, Tarija, Bolivia.'}, {'ForeName': 'Faustino', 'Initials': 'F', 'LastName': 'Torrico', 'Affiliation': 'Colectivo de Estudios Aplicados y Desarrollo Social (CEADES), Cochabamba, Bolivia.'}, {'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Ribeiro', 'Affiliation': 'Drugs for Neglected Diseases initiative (DNDi), Geneva, Switzerland.'}, {'ForeName': 'Alejandro Gabriel', 'Initials': 'AG', 'LastName': 'Schijman', 'Affiliation': 'Instituto de Investigaciones en Ingeniería Genética y Biología Molecular ""Dr. Héctor N. Torres"" (INGEBI-CONICET), Buenos Aires, Argentina.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkab446']
2212,35192801,"Short-term supervised virtual training maintains intensity of effort and represents an efficacious alternative to traditional studio-based, supervised strength training.","BACKGROUND


Virtual personal training might represent an uncomplicated, accessible, and time-efficient approach to supervised strength training, particularly under government-imposed lockdown or closure of fitness facilities. However, there appears a dearth of literature evaluating the efficacy of virtual personal training.
METHODS


The present project considered two studies considering supervised virtual strength training. Study 1 considered trained participants being supervised one-to-one through traditional resistance exercise sessions in a strength training studio (STUD), compared to a virtual personal training protocol performed using bodyweight resistance exercises (VIRT). This study utilized a crossover design whereby male (n = 13) and female (n = 7) participants were tested for body composition using BodPod, and strength for bench press, leg press, and high-row exercises. Participants were then randomly assigned to 3-weeks of VIRT or 3-weeks of STUD training. Following each 3-week training period, participants had a 1-week period without training whereby mid-intervention testing occurred, after which participants then completed the alternate training intervention. For study 2, we surveyed the client base of a chain of training facilities that had begun offering virtual personal training during lockdown to explore their views on this approach.
RESULTS


Strength and body composition changes were similar between groups, however for neither condition did results surpass the smallest meaningful change. The remaining survey data suggests that supervised virtual resistance training yields similar perceptions of effort, motivation, enjoyment, and supervision quality, compared to traditional supervised studio training.
CONCLUSION


Based on the current data, it appears that short-term supervised virtual resistance training is as efficacious as traditional supervised studio-based resistance training.",2022,"The remaining survey data suggests that supervised virtual resistance training yields similar perceptions of effort, motivation, enjoyment, and supervision quality, compared to traditional supervised studio training.
",['male (n=13) and female (n=7) participants'],"['VIRT or 3-weeks of STUD training', 'trained participants being supervised one-to-one through traditional resistance exercise sessions in a strength training studio (STUD), compared to a virtual personal training protocol performed using bodyweight resistance exercises (VIRT']","['Strength and body composition changes', 'effort, motivation, enjoyment, and supervision quality']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.00439233,"The remaining survey data suggests that supervised virtual resistance training yields similar perceptions of effort, motivation, enjoyment, and supervision quality, compared to traditional supervised studio training.
","[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Carlson', 'Affiliation': 'Discover Strength, 4450 Excelsior Blvd, Suite 490, St. Louis Park, MN 55416, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gschneidner', 'Affiliation': 'Discover Strength, 4450 Excelsior Blvd, Suite 490, St. Louis Park, MN 55416, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Steele', 'Affiliation': 'Faculty of Sport, Health and Social Science, Solent University, East Park Terrace, Southampton, United Kingdom.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Fisher', 'Affiliation': 'Faculty of Sport, Health and Social Science, Solent University, East Park Terrace, Southampton, United Kingdom. Electronic address: James.Fisher@solent.ac.uk.'}]",Physiology & behavior,['10.1016/j.physbeh.2022.113748']
2213,35193081,"Added bovine milk fat globule membrane in formula: Growth, body composition, and safety through age 2: An RCT.","OBJECTIVE


The aim of this study was to assess the effects of an experimental formula (EF) with added whey protein-lipid concentrate (5 g/L; source of bovine milk fat globule membrane [bMFGM]) on growth, body composition, and safety through 24 mo of age in term infants.
METHODS


This was a double-blinded, randomized controlled trial conducted in Santiago, Chile. Infants were enrolled before 120 d and randomized to receive standard cow's milk-based formula (SF) or EF through the first year of life. Breastfed infants were the reference (HM). Growth (weight-for-age [WAZ], length-for-age [LAZ], BMI-for-age [BAZ], headcircumference-for-age [HCZ] z-scores); body composition (fat mass [FM] and fat-free mass, percentage body fat [%BF]); and adverse events through day 730 were recorded. Outcome trajectories were analyzed using a single generalized estimating equation testing the interaction between group and visit.
RESULTS


We recruited 582 infants (HM = 235; SF = 174; EF = 173); 478 (>80%) completed the study. At baseline, only WAZ was different between the formula groups (0.14 lower in EF versus SF group, P = 0.035). WAZ, LAZ, and BAZ trajectories were higher from baseline to days 365 and 730 in EF or SF compared with HM (all P < 0.05). No differences in changes in body composition were observed between the formula groups. For EF versus HM, %BF was lower at day 180; however, this difference reversed from day 365. Fat-free mass was higher in formula groups compared with HM at all time points. No group difference in adverse event incidence rate was detected.
CONCLUSION


During the first 2 y of life, infant formula with added bMFGM supports typical growth and safety compared with a standard formula.",2022,"WAZ, LAZ, and BAZ trajectories were higher from baseline to days 365 and 730 in EF or SF compared with HM (all P < 0.05).","['24 mo of age in term infants', '582 infants (HM\xa0=\xa0235']","[""standard cow's milk-based formula (SF) or EF"", 'experimental formula (EF) with added whey protein-lipid concentrate', 'bMFGM']","['WAZ, LAZ, and BAZ trajectories', 'body composition', 'adverse event incidence rate', 'Fat-free mass', 'growth, body composition, and safety']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452742', 'cui_str': 'Formula milk'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.129317,"WAZ, LAZ, and BAZ trajectories were higher from baseline to days 365 and 730 in EF or SF compared with HM (all P < 0.05).","[{'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Jaramillo-Ospina', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Santiago, Chile.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Toro-Campos', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Santiago, Chile.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Murguía-Peniche', 'Affiliation': 'Medical and Scientific Affairs, Reckitt|Mead Johnson Nutrition, Evansville, Indiana, United States.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Wampler', 'Affiliation': 'Medical and Scientific Affairs, Reckitt|Mead Johnson Nutrition, Evansville, Indiana, United States.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Wu', 'Affiliation': 'Medical and Scientific Affairs, Reckitt|Mead Johnson Nutrition, Evansville, Indiana, United States.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Berseth', 'Affiliation': 'Medical and Scientific Affairs, Reckitt|Mead Johnson Nutrition, Evansville, Indiana, United States; Brightseed, Medical and Scientific Affairs, San Francisco, California, United States.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Uauy', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Santiago, Chile. Electronic address: profesor.ricardo.uauy@gmail.com.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2022.111599']
2214,35193054,"Phase I, randomized, double-blind, single-dose study to assess the pharmacokinetics, safety, and immunogenicity of the proposed biosimilar SCT630 and adalimumab in healthy Chinese subjects.","We aimed to compare the pharmacokinetics, safety, and immunogenicity of the adalimumab biosimilar SCT630 with those of its reference (adalimumab, Humira®). This study involved a randomized, double-blind, parallel-controlled design; healthy subjects (N = 146) were randomly distributed into two groups to receive a single-dose subcutaneous injection of 40 mg SCT630 or 40 mg adalimumab, with a 71-day follow up. The bioequivalence of the primary pharmacokinetic parameters (AUC 0 -t) and maximum observed serum concentration (C max ) between SCT630 and adalimumab were the primary endpoints; safety and immunogenicity of SCT630 compared with those of adalimumab were the secondary endpoints. The geometric mean C max  ratio of SCT630 to adalimumab and its 90% confidence interval (CI) were 116.02% and 108.66%-123.88%, AUC 0 -t ratio and 90% CI were 109.47% and 99.80%-120.08%, and AUC 0-∞  ratio and 90% CI were 109.24% and 99.80%-120.78%. These PK parameters fulfilled the equivalence criterion of 80.00%-125.00%. Treatment-emergent adverse events (TEAEs) occurred in 62 (84.9%) and 61 (83.6%) subjects; mild and moderate drug-related TEAEs were observed in 60 (82.2%) and 59 (80.8%) subjects in the adalimumab and SCT630 groups, respectively. On day 71, 69 (95.8%) subjects in the adalimumab group and 66 (93%) in the SCT630 group reported positive anti-drug antibodies. Among them, 15 (21.7%) and 11 (16.7%) subjects showed positive neutralizing antibodies, with no significant difference. SCT630 was well tolerated and demonstrated PK and safety profiles similar to adalimumab. The profiles support the initiation of further confirmatory study to demonstrate the clinical similarity of SCT630 to adalimumab.",2022,The bioequivalence of the primary pharmacokinetic parameters (AUC 0 -t) and maximum observed serum concentration (C max ) between SCT630 and adalimumab were the primary endpoints; safety and immunogenicity of SCT630 compared with those of adalimumab were the secondary endpoints.,"['healthy subjects (N\xa0=\xa0146', 'healthy Chinese subjects']","['biosimilar SCT630 and adalimumab', 'adalimumab', 'SCT630 or 40\xa0mg adalimumab', 'SCT630']","['positive neutralizing antibodies', 'serum concentration (C max ', 'positive anti-drug antibodies', 'geometric mean C max  ratio of SCT630 to adalimumab and its 90% confidence interval (CI', 'pharmacokinetics, safety, and immunogenicity', 'safety and immunogenicity of SCT630']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",146.0,0.140647,The bioequivalence of the primary pharmacokinetic parameters (AUC 0 -t) and maximum observed serum concentration (C max ) between SCT630 and adalimumab were the primary endpoints; safety and immunogenicity of SCT630 compared with those of adalimumab were the secondary endpoints.,"[{'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, PR China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, PR China.'}, {'ForeName': 'Chunpu', 'Initials': 'C', 'LastName': 'Lei', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, PR China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, PR China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, PR China.'}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, PR China.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Bai', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, PR China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, PR China.'}, {'ForeName': 'Yinjuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, PR China.'}, {'ForeName': 'Ju', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, PR China.'}, {'ForeName': 'Liangzhi', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, PR China.'}, {'ForeName': 'Xinghe', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, PR China. Electronic address: wangxh@bjsjth.cn.'}]",International immunopharmacology,['10.1016/j.intimp.2022.108599']
2215,35197068,Impact of web-based health education on HPV vaccination uptake among college girl students in Western and Northern China: a follow-up study.,"OBJECTIVE


To investigate the effect of a web-based educational intervention on changing female college students' willingness and uptake of human papillomavirus (HPV) vaccines, and factors associated with HPV vaccination acceptance in Western and Northern China.
METHODS


A web-based cluster randomized controlled trial was conducted in Western and Northern China from February to May 2020. A total of 967 female freshmen were recruited from two universities through convenience sampling, stratified sampling (liberal arts or sciences), and cluster sampling. Eligible students were randomized into intervention and control group with a 1:1 allocation ratio. The intervention group received seven days of web-based health education regarding HPV and HPV vaccines, whereas the control group received non-HPV-related materials. All students were asked to complete a post-intervention questionnaire to measure their awareness, uptake, and willingness to receive HPV vaccination at 7-day and one-month intervals. The chi-square test and Student's t-test were employed to examine the differences between the intervention and control groups for categorical and continuous data. Logistic regressions were used to analyze factors associated with vaccination intentions.
RESULTS


Nine hundred forty-six female freshmen aged 18.99 ± 0.63 years were enrolled in the study, with 532 in the intervention group and 414 in the control group. Prior to the intervention, 63.8%, 66.3%, and 60.8% of students had heard of HPV, HPV-related diseases, and HPV vaccines, respectively. Only 2.2% of students reported being vaccinated, but 33.0% were willing to be vaccinated against HPV. After seven days of education, students in the intervention group exhibited higher awareness (p < 0.001) and knowledge scores (5.13 ± 1.23 vs. 3.10 ± 1.99, p < 0.001) than those in the control group. Similarly, in the intervention groups, willingness to be vaccinated against HPV was significantly higher than in the control groups (p < 0.001). The high cost (57.7%) and concerns about adverse events (56.0%) were the main reasons female college students did not accept HPV vaccines. School location in urban areas, parents' higher education backgrounds, history of HPV vaccination counseling, history of sexual behavior, and having heard of HPV vaccines were associated with a higher willingness to be vaccinated.
CONCLUSION


Female college students' HPV vaccination uptake is insufficient, and they have minimal detailed knowledge about HPV and its vaccines. Web-based health education on HPV vaccines is an easy, feasible, and effective way to improve the awareness and acceptance of HPV vaccination among female college students, but it has limited effect on HPV vaccination uptake.",2022,"After seven days of education, students in the intervention group exhibited higher awareness (p < 0.001) and knowledge scores (5.13 ± 1.23 vs. 3.10 ± 1.99, p < 0.001) than those in the control group.","['college girl students in Western and Northern China', 'Nine hundred forty-six female freshmen aged 18.99\u2009±\u20090.63\xa0years were enrolled in the study, with 532 in the intervention group and 414 in the control group', 'Eligible students', 'female college students', 'A total of 967 female freshmen were recruited from two universities through convenience sampling, stratified sampling (liberal arts or sciences), and cluster sampling', 'A web-based cluster randomized controlled trial was conducted in Western and Northern China from February to May 2020', 'Female college students', ""female college students' willingness and uptake of human papillomavirus (HPV) vaccines, and factors associated with HPV vaccination acceptance in Western and Northern China""]","['web-based educational intervention', 'seven days of web-based health education regarding HPV and HPV vaccines, whereas the control group received non-HPV-related materials', 'web-based health education']","['heard of HPV, HPV-related diseases, and HPV vaccines', 'higher awareness', 'HPV vaccination uptake', 'knowledge scores', 'willingness to be vaccinated against HPV']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517468', 'cui_str': '0.63'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0183992,"After seven days of education, students in the intervention group exhibited higher awareness (p < 0.001) and knowledge scores (5.13 ± 1.23 vs. 3.10 ± 1.99, p < 0.001) than those in the control group.","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Beijing Office for Cancer Prevention and Control, Peking University Cancer Hospital & Institute, Beijing, 100142, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Women's Hospital, Zhejiang University School of Medicine, Hangzhou, 310006, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Chenghua District Center for Disease Control and Prevention, Chengdu, 610057, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Student Affairs Department, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Xiao-Yu', 'Initials': 'XY', 'LastName': 'Feng', 'Affiliation': 'Shanxi University of Finance and Economics, Taiyuan, 030006, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, 610041, China. lijingwcph@scu.edu.cn.'}]",BMC women's health,['10.1186/s12905-022-01625-0']
2216,35197060,Permethrin-treated baby wraps for the prevention of malaria: results of a randomized controlled pilot study in rural Uganda.,"BACKGROUND


Progress against malaria has stalled and may even be slipping backwards in high-burden countries. This is due to a range of factors including insecticide resistance and mosquito feeding behaviours that limit contact with widely-employed interventions including long-lasting insecticidal nets and indoor-residual spraying. Thus, further innovations in malaria control are urgently needed.
METHODS


The pilot was a randomized, placebo-controlled pilot study of permethrin-treated baby wraps-known locally as lesus-in children 6-18 months of age at a single site in rural western Uganda. Fifty mother-infant pairs were assigned to permethrin-treated or untreated lesus in a 1:1 allocation. Participants and clinical staff were blinded to group assignments through use of sham treatment and re-treatment of lesus. Participants attended scheduled clinic visits every 2 weeks for a total 12 weeks. The primary outcome of interest was the safety of the intervention, assessed as changes in the frequency of use, rates of discontinuation, and incidence of adverse events, such as skin rash. Secondary outcomes included acceptability and feasibility of the intervention as measured through participant satisfaction and completion of study activities, respectively.
RESULTS


Overall, rates of retention and participation were relatively high with 86.0% (43 of 50) of participants completing all scheduled visits, including 18 (75.0%) and 25 (96.2%) in the intervention and control arms respectively. By the conclusion of the 12-week follow-up period, one adverse event (0.35 events per 100 person-weeks, one-sided 95% CI 0.0-1.65) was reported. Satisfaction with the lesu was high in both groups. In each study arm, there were five incident RDT positive results, but the only PCR-positive results were observed in the control group (n = 2).
CONCLUSIONS


Permethrin-treated baby wraps were well-tolerated and broadly acceptable. Adverse events were infrequent and mild. These findings support future trials seeking to determine the efficacy of treated wraps to prevent P. falciparum malaria infection in young children as a complementary tool to existing household-based interventions.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04102592, Registered 25 September 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT04102592.",2022,"Overall, rates of retention and participation were relatively high with 86.0% (43 of 50) of participants completing all scheduled visits, including 18 (75.0%) and 25 (96.2%) in the intervention and control arms respectively.","['Fifty mother-infant pairs', 'rural Uganda', 'children 6-18\xa0months of age at a single site in rural western Uganda', 'young children']","['Permethrin-treated baby wraps', 'permethrin-treated baby wraps-known locally', 'placebo', 'permethrin-treated or untreated lesus in a 1:1 allocation']","['PCR-positive results', 'Overall, rates of retention and participation', 'Satisfaction', 'adverse event', 'Adverse events', 'acceptability and feasibility of the intervention as measured through participant satisfaction and completion of study activities, respectively', 'frequency of use, rates of discontinuation, and incidence of adverse events, such as skin rash']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0070455', 'cui_str': 'Permethrin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C3888499', 'cui_str': 'Polymerase chain reaction positive'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",,0.360275,"Overall, rates of retention and participation were relatively high with 86.0% (43 of 50) of participants completing all scheduled visits, including 18 (75.0%) and 25 (96.2%) in the intervention and control arms respectively.","[{'ForeName': 'Ross M', 'Initials': 'RM', 'LastName': 'Boyce', 'Affiliation': 'Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, 123 West Franklin Street, Suite 230, RM 2151, Chapel Hill, NC, 27599, USA. roboyce@med.unc.edu.'}, {'ForeName': 'Enid', 'Initials': 'E', 'LastName': 'Muhindo', 'Affiliation': 'Department of Community Health, Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Baguma', 'Affiliation': 'Department of Community Health, Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Rabbison', 'Initials': 'R', 'LastName': 'Muhindo', 'Affiliation': 'Department of Community Health, Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Bwambale', 'Initials': 'B', 'LastName': 'Shem', 'Affiliation': 'Bugoye Level III Health Center, Uganda Ministry of Health, Kasese, Uganda.'}, {'ForeName': 'Ruthly', 'Initials': 'R', 'LastName': 'François', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Hawke', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Bonnie E', 'Initials': 'BE', 'LastName': 'Shook-Sa', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Ntaro', 'Affiliation': 'Department of Community Health, Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Nalusaji', 'Affiliation': 'Epicentre Mbarara Research Centre, Mbarara, Uganda.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Nyehangane', 'Affiliation': 'Epicentre Mbarara Research Centre, Mbarara, Uganda.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Reyes', 'Affiliation': 'Division of Hospital Medicine, UNC School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Juliano', 'Affiliation': 'Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, 123 West Franklin Street, Suite 230, RM 2151, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Siedner', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA, 02114, USA.'}, {'ForeName': 'Sarah G', 'Initials': 'SG', 'LastName': 'Staedke', 'Affiliation': 'Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.'}, {'ForeName': 'Edgar M', 'Initials': 'EM', 'LastName': 'Mulogo', 'Affiliation': 'Department of Community Health, Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda.'}]",Malaria journal,['10.1186/s12936-022-04086-w']
2217,35197041,In-vitro characterization and evaluation of mesoporous titanium dioxide composite hydroxyapatite and its effectiveness in occluding dentine tubules.,"BACKGROUND


To synthesize mesoporous titanium dioxide composite hydroxyapatite (TiO 2 -HAP) and to evaluate its effectiveness in sealing of occluding dentine tubules.
METHODS


TiO 2 -HAP was synthesized by chemical precipitation method and characterized using infrared absorption spectrometer, X-ray diffraction, scanning electron microscope, and specific surface area detector. Forty completely extracted molars were prepared and randomly assigned into Control group, Gluma group, HAP group and TiO 2 -HAP group according to different treatments. The characteristics of HAP and TiO 2 -HAP and the sealing effectiveness of dentine tubules in these four groups, including infrared spectrum, surface contact angle, pore size distribution, and re-mineralized enamel surface profiles, were analyzed by suitable characterized techniques. The cytotoxicity of the synthesized TiO 2 -HAP was tested and compared using 3-(4,5)-dimethylthiahiazo(-z-y1)-3,5-di-phenytetrazoliumromide (MTT) colorimetry.
RESULTS


Our results showed TiO 2 -HAP group had significantly lower contact angle, higher specific surface area, and wider range of pore size distribution than other groups. The majority of dentinal tubules in the TiO 2 -HAP group were blocked by white matter in a uniformed manner, and the crystals arranged in order grew along the axial direction. In addition, no significant difference in optical density (OD) value was found between control group and TiO 2 -HAP group (P > 0.05), and cell growth was good in TiO 2 -HAP group, indicating no cytotoxicity of TiO 2 -HAP.
CONCLUSIONS


The MTT assay identified that TiO 2 -HAP had little effect on the L929 cell line. We showed TiO 2 -HAP might be used as a remineralization agent in enamel caries-like lesions.",2022,"The majority of dentinal tubules in the TiO 2 -HAP group were blocked by white matter in a uniformed manner, and the crystals arranged in order grew along the axial direction.","['Forty completely extracted molars', 'occluding dentine tubules']","['3-(4,5)-dimethylthiahiazo(-z-y1)-3,5-di-phenytetrazoliumromide (MTT) colorimetry', 'titanium dioxide composite hydroxyapatite (TiO 2 -HAP', 'mesoporous titanium dioxide composite hydroxyapatite', 'Gluma group, HAP group and TiO 2 -HAP']","['contact angle, higher specific surface area, and wider range of pore size distribution', 'cell growth', 'majority of dentinal tubules', 'optical density (OD) value']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0009407', 'cui_str': 'Colorimetry'}, {'cui': 'C0076733', 'cui_str': 'titanium dioxide'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C2355432', 'cui_str': 'oxo(5,10,15,20-tetra(4-pyridyl)porphyrinato)titanium(IV)'}, {'cui': 'C0061452', 'cui_str': 'Gluma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0227017', 'cui_str': 'Dentinal tubules'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",40.0,0.04151,"The majority of dentinal tubules in the TiO 2 -HAP group were blocked by white matter in a uniformed manner, and the crystals arranged in order grew along the axial direction.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Xiamen Key Laboratory of Stomatological Disease Diagnosis and Treatment, Stomatological Hospital of Xiamen Medical College, No. 1309, Lvling Road, Huli District, Xiamen, 361008, Fujian, China.'}, {'ForeName': 'Xuehong', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Xiamen Key Laboratory of Stomatological Disease Diagnosis and Treatment, Stomatological Hospital of Xiamen Medical College, No. 1309, Lvling Road, Huli District, Xiamen, 361008, Fujian, China.'}, {'ForeName': 'Chienyu', 'Initials': 'C', 'LastName': 'Chu', 'Affiliation': 'Xiamen Key Laboratory of Stomatological Disease Diagnosis and Treatment, Stomatological Hospital of Xiamen Medical College, No. 1309, Lvling Road, Huli District, Xiamen, 361008, Fujian, China.'}, {'ForeName': 'Pingting', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': 'Xiamen Key Laboratory of Stomatological Disease Diagnosis and Treatment, Stomatological Hospital of Xiamen Medical College, No. 1309, Lvling Road, Huli District, Xiamen, 361008, Fujian, China.'}, {'ForeName': 'Honglan', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Xiamen Key Laboratory of Stomatological Disease Diagnosis and Treatment, Stomatological Hospital of Xiamen Medical College, No. 1309, Lvling Road, Huli District, Xiamen, 361008, Fujian, China.'}, {'ForeName': 'Bizhu', 'Initials': 'B', 'LastName': 'Luo', 'Affiliation': 'Xiamen Key Laboratory of Stomatological Disease Diagnosis and Treatment, Stomatological Hospital of Xiamen Medical College, No. 1309, Lvling Road, Huli District, Xiamen, 361008, Fujian, China.'}, {'ForeName': 'Changwei', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Xiamen Key Laboratory of Stomatological Disease Diagnosis and Treatment, Stomatological Hospital of Xiamen Medical College, No. 1309, Lvling Road, Huli District, Xiamen, 361008, Fujian, China. yl_yin@sina.cn.'}]",BMC oral health,['10.1186/s12903-021-01989-z']
2218,35197335,Postpartum blood pressure self-management following hypertensive pregnancy: protocol of the Physician Optimised Post-partum Hypertension Treatment (POP-HT) trial.,"INTRODUCTION


New-onset hypertension affects approximately 10% of pregnancies and is associated with a significant increase in risk of cardiovascular disease in later life, with blood pressure measured 6 weeks postpartum predictive of blood pressure 5-10 years later. A pilot trial has demonstrated that improved blood pressure control, achevied via self-management during the puerperium, was associated with lower blood pressure 3-4 years postpartum. Physician Optimised Post-partum Hypertension Treatment (POP-HT) will formally evaluate whether improved blood pressure control in the puerperium results in lower blood pressure at 6 months post partum, and improvements in cardiovascular and cerebrovascular phenotypes.
METHODS AND ANALYSIS


POP-HT is an open-label, parallel arm, randomised controlled trial involving 200 women aged 18 years or over, with a diagnosis of pre-eclampsia or gestational hypertension, and requiring antihypertensive medication at discharge. Women are recruited by open recruitment and direct invitation around time of delivery and randomised 1:1 to, either an intervention comprising physician-optimised self-management of postpartum blood pressure or, usual care. Women in the intervention group upload blood pressure readings to a 'smartphone' app that provides algorithm-driven individualised medication-titration. Medication changes are approved by physicians, who review blood pressure readings remotely. Women in the control arm follow assessment and medication adjustment by their usual healthcare team. The primary outcome is 24-hour average ambulatory diastolic blood pressure at 6-9 months post partum. Secondary outcomes include: additional blood pressure parameters at baseline, week 1 and week 6; multimodal cardiovascular assessments (CMR and echocardiography); parameters derived from multiorgan MRI including brain and kidneys; peripheral macrovascular and microvascular measures; angiogenic profile measures taken from blood samples and levels of endothelial circulating and cellular biomarkers; and objective physical activity monitoring and exercise assessment. An additional 20 women will be recruited after a normotensive pregnancy as a comparator group for endothelial cellular biomarkers.
ETHICS AND DISSEMINATION


IRAS PROJECT ID 273353. This trial has received a favourable opinion from the London-Surrey Research Ethics Committee and HRA (REC Reference 19/LO/1901). The investigator will ensure that this trial is conducted in accordance with the principles of the Declaration of Helsinki and follow good clinical practice guidelines. The investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study. Authors will acknowledge that the study was funded by the British Heart Foundation Clinical Research Training Fellowship (BHF Grant number FS/19/7/34148). Authorship will be determined in accordance with the ICMJE guidelines and other contributors will be acknowledged.
TRIAL REGISTRATION NUMBER


NCT04273854.",2022,Women in the intervention group upload blood pressure readings to a 'smartphone' app that provides algorithm-driven individualised medication-titration.,"['20\u2009women will be recruited after a normotensive pregnancy as a comparator group for endothelial cellular biomarkers', 'hypertensive pregnancy', '200\u2009women aged 18 years or over, with a diagnosis of pre-eclampsia or gestational hypertension, and requiring antihypertensive medication at discharge']","['Physician Optimised Post-partum Hypertension Treatment (POP-HT', 'POP-HT', 'HRA', 'intervention comprising physician-optimised self-management of postpartum blood pressure or, usual care']","['cardiovascular and cerebrovascular phenotypes', 'blood pressure control', 'additional blood pressure parameters at baseline, week 1 and week 6; multimodal cardiovascular assessments (CMR and echocardiography); parameters derived from multiorgan MRI including brain and kidneys; peripheral macrovascular and microvascular measures; angiogenic profile measures taken from blood samples and levels of endothelial circulating and cellular biomarkers; and objective physical activity monitoring and exercise assessment', '24-hour average ambulatory diastolic blood pressure', 'blood pressure readings', 'risk of cardiovascular disease']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0341934', 'cui_str': 'Transient hypertension of pregnancy'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}, {'cui': 'C1619700', 'cui_str': 'Renal aplasia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",200.0,0.0650484,Women in the intervention group upload blood pressure readings to a 'smartphone' app that provides algorithm-driven individualised medication-titration.,"[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Kitt', 'Affiliation': 'Division of Cardiovascular Medicine, University of Oxford, Oxford, UK jamie.kitt@cardiov.ox.ac.uk.'}, {'ForeName': 'Annabelle', 'Initials': 'A', 'LastName': 'Frost', 'Affiliation': 'Division of Cardiovascular Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Mollison', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katherine Louise', 'Initials': 'KL', 'LastName': 'Tucker', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Suriano', 'Affiliation': 'Division of Cardiovascular Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Kenworthy', 'Affiliation': 'Oxford Cardiovascular Clinical Research Facility, University of Oxford, Oxford, UK.'}, {'ForeName': 'Annabelle', 'Initials': 'A', 'LastName': 'McCourt', 'Affiliation': 'Division of Cardiovascular Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Woodward', 'Affiliation': 'Division of Cardiovascular Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Tan', 'Affiliation': 'Division of Cardiovascular Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Winok', 'Initials': 'W', 'LastName': 'Lapidaire', 'Affiliation': 'Division of Cardiovascular Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Mills', 'Affiliation': 'Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Khan', 'Affiliation': 'Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Tunnicliffe', 'Affiliation': 'Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Raman', 'Affiliation': 'Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Santos', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Roman', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Henner', 'Initials': 'H', 'LastName': 'Hanssen', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Mackillop', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UK.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Cairns', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UK.""}, {'ForeName': 'Basky', 'Initials': 'B', 'LastName': 'Thilaganathan', 'Affiliation': ""Obstetrics and Gynecology, University of London Saint George's, London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Chappell', 'Affiliation': ""Women's Health Academic Centre, King's College London, London, UK.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Aye', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UK.""}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Lewandowski', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'McManus', 'Affiliation': 'Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Leeson', 'Affiliation': 'Division of Cardiovascular Medicine, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2021-051180']
2219,35190388,Full endoscopic versus open discectomy for sciatica: randomised controlled non-inferiority trial.,"OBJECTIVE


To assess whether percutaneous transforaminal endoscopic discectomy (PTED) is non-inferior to conventional open microdiscectomy in reduction of leg pain caused by lumbar disc herniation.
DESIGN


Multicentre randomised controlled trial with non-inferiority design.
SETTING


Four hospitals in the Netherlands.
PARTICIPANTS


613 patients aged 18-70 years with at least six weeks of radiating leg pain caused by lumbar disc herniation. The trial included a predetermined set of 125 patients receiving PTED who were the learning curve cases performed by surgeons who did not do PTED before the trial.
INTERVENTIONS


PTED (n=179) compared with open microdiscectomy (n=309).
MAIN OUTCOME MEASURES


The primary outcome was self-reported leg pain measured by a 0-100 visual analogue scale at 12 months, assuming a non-inferiority margin of 5.0. Secondary outcomes included complications, reoperations, self-reported functional status as measured with the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery. Outcomes were measured until one year after surgery and were longitudinally analysed according to the intention-to-treat principle. Patients belonging to the PTED learning curve were omitted from the primary analyses.
RESULTS


At 12 months, patients who were randomised to PTED had a statistically significantly lower visual analogue scale score for leg pain (median 7.0, interquartile range 1.0-30.0) compared with patients randomised to open microdiscectomy (16.0, 2.0-53.5) (between group difference of 7.1, 95% confidence interval 2.8 to 11.3). Blood loss was less, length of hospital admission was shorter, and timing of postoperative mobilisation was earlier in the PTED group than in the open microdiscectomy group. Secondary patient reported outcomes such as the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery, were similarly in favour of PTED. Within one year, nine (5%) in the PTED group compared with 14 (6%) in the open microdiscectomy group had repeated surgery. Per protocol analysis and sensitivity analyses including the patients of the learning curve resulted in similar outcomes to the primary analysis.
CONCLUSIONS


PTED was non-inferior to open microdiscectomy in reduction of leg pain. PTED resulted in more favourable results for self-reported leg pain, back pain, functional status, quality of life, and recovery. These differences, however, were small and may not reach clinical relevance. PTED can be considered as an effective alternative to open microdiscectomy in treating sciatica.
TRIAL REGISTRATION


NCT02602093ClinicalTrials.gov NCT02602093.",2022,"PTED resulted in more favourable results for self-reported leg pain, back pain, functional status, quality of life, and recovery.","['125 patients receiving PTED who were the learning curve cases performed by surgeons who did not do PTED before the trial', '613 patients aged 18-70 years with at least six weeks of radiating leg pain caused by lumbar disc herniation', 'Four hospitals in the Netherlands']","['open microdiscectomy', 'Full endoscopic versus open discectomy', 'percutaneous transforaminal endoscopic discectomy (PTED']","['length of hospital admission', 'Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery', 'complications, reoperations, self-reported functional status as measured with the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery', 'leg pain, back pain, functional status, quality of life, and recovery', 'visual analogue scale score for leg pain', 'self-reported leg pain measured by a 0-100 visual analogue scale', 'postoperative mobilisation', 'Blood loss', 'leg pain']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C2936637', 'cui_str': 'Learning Curve'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332301', 'cui_str': 'Radiating to'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0457629', 'cui_str': 'Lumbar microdiscectomy'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",613.0,0.360765,"PTED resulted in more favourable results for self-reported leg pain, back pain, functional status, quality of life, and recovery.","[{'ForeName': 'Pravesh S', 'Initials': 'PS', 'LastName': 'Gadjradj', 'Affiliation': 'Department of Neurosurgery, Erasmus MC University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Sidney M', 'Initials': 'SM', 'LastName': 'Rubinstein', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Netherlands.'}, {'ForeName': 'Wilco C', 'Initials': 'WC', 'LastName': 'Peul', 'Affiliation': 'Department of Neurosurgery, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Depauw', 'Affiliation': 'Department of Neurosurgery, Elisabeth-TweeSteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Carmen L', 'Initials': 'CL', 'LastName': 'Vleggeert-Lankamp', 'Affiliation': 'Department of Neurosurgery, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Ankie', 'Initials': 'A', 'LastName': 'Seiger', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Netherlands.'}, {'ForeName': 'Job Lc', 'Initials': 'JL', 'LastName': 'van Susante', 'Affiliation': 'Department of Orthopedic Surgery, Rijnstate Hospital, Arnhem, Netherlands.'}, {'ForeName': 'Michiel R', 'Initials': 'MR', 'LastName': 'de Boer', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Netherlands.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Netherlands.'}, {'ForeName': 'Biswadjiet S', 'Initials': 'BS', 'LastName': 'Harhangi', 'Affiliation': 'Department of Neurosurgery, Erasmus MC University Medical Center Rotterdam, Rotterdam, Netherlands b.s.harhangi@erasmusmc.nl.'}]",BMJ (Clinical research ed.),['10.1136/bmj-2021-065846']
2220,35191131,"Sensorimotor effects of plasticity-inducing percutaneous peripheral nerve stimulation protocols: a blinded, randomized clinical trial.","BACKGROUND


Electrical stimulation of skin afferents can induce somatosensory plasticity in humans. Nevertheless, it is unknown if this is possible to do through percutaneous stimulation of a peripheral nerve, which will allow for regional anaesthesia interventions. Furthermore, potentiation protocols applied over mainly non-nociceptive fibres inhibit nociception in rodents, but this has not been tested in humans.
OBJECTIVE


To determine whether a protocol aiming to depress the nociceptive circuit and another aiming to potentiate non-nociceptive circuits produce regional hypoalgesia and changes in motor function, applied through percutaneous peripheral nerve stimulation (pPNS), and to assess which of them is more promising for pain relief, immediately and 24 h after the intervention.
METHODS


PT-cLF protocol aims to depress the nociceptive pathway through Pain Threshold, continuous Low Frequency stimulation and ST-bHF aims to produce potentiation of the non-nociceptive pathway, through Sensory Threshold burst stimulation at High Frequency. All subjects (n = 29) went through both protocols and a control condition in a randomized and blinded crossover design.
RESULTS


Compared to control, ST-bHF induced distal hypoalgesia, towards electrical (p = 0.04) and mechanical stimuli (p = 0.02) and produced mechanical hypoesthesia (p = 0.02). Contrarily, hypoalgesia was not observed after PT-cLF (p > 0.05) but increased electrical motor threshold (p = 0.04), reduced motor recruitment (p = 0.03), and the subjects reported feeling reduced strength (p < 0.01).
CONCLUSION


This works provides evidence that is possible to induce antinociceptive plasticity in a wide territory using pPNS. Moreover, it demonstrates for the first time in humans that a protocol aiming to produce long-term potentiation applied predominantly over non-nociceptive afferents induces hypoesthesia and hypoalgesia.",2022,"Compared to control, ST-bHF induced distal hypoalgesia, towards electrical (p=0.04) and mechanical stimuli (p=0.02) and produced mechanical hypoesthesia (p=0.02).",['humans'],"['plasticity-inducing percutaneous peripheral nerve stimulation protocols', 'percutaneous peripheral nerve stimulation (pPNS']","['electrical motor threshold', 'reduced motor recruitment', 'mechanical hypoesthesia', 'distal hypoalgesia, towards electrical (p=0.04) and mechanical stimuli']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",,0.0291186,"Compared to control, ST-bHF induced distal hypoalgesia, towards electrical (p=0.04) and mechanical stimuli (p=0.02) and produced mechanical hypoesthesia (p=0.02).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Beltrá', 'Affiliation': 'Physical Therapy and Advanced Rehabilitation Clinic RehAv Elche, Elche, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ruiz-Del-Portal', 'Affiliation': 'Physical Therapy and Advanced Rehabilitation Clinic RehAv Elche, Elche, Spain.'}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Ortega', 'Affiliation': 'Physical Therapy and Advanced Rehabilitation Clinic RehAv Elche, Elche, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Valdesuso', 'Affiliation': 'Physical Therapy and Advanced Rehabilitation Clinic RehAv Elche, Elche, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Delicado-Miralles', 'Affiliation': 'Instituto de Neurociencias, Universidad Miguel Hernández-CSIC, San Juan de Alicante, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Velasco', 'Affiliation': 'Instituto de Neurociencias, Universidad Miguel Hernández-CSIC, San Juan de Alicante, Spain.'}]","European journal of pain (London, England)",['10.1002/ejp.1928']
2221,35191105,Dimensional changes of keratinized mucosa after accordion versus conventional free gingival graft around dental implants: A randomized two-arm parallel clinical trial.,"OBJECTIVES


Free gingival graft (FGG) is the most effective way to increase the apico-coronal width of the keratinized mucosa. In case of limited donor tissue, the accordion technique can be used. This study compared FGG for dimensional and clinical changes using accordion and conventional methods.
MATERIALS AND METHODS


Ninety-four implants with keratinized tissue deficiency (<2 mm) were randomly assigned to treatment with accordion (49 implants) and conventional (45 implants) FGG. Endpoints including apico-coronal keratinized tissue width, vertical shrinkage, vestibular depth, probing depth, bleeding on probing, and plaque index were measured. The graft harvesting and recipient bed preparation method were similar in the two groups, and the only difference was the graft length. FGG was harvested with a length 40% shorter than the mesiodistal length of the recipient area in the accordion method and as much as the recipient area in the conventional method.
RESULTS


vertical graft shrinkage 1, 3, and 6 months following conventional graft placement was 12.04 ± 14.99, 17.12 ± 20.40, and 23.29 ± 24.63 percent, respectively. In the accordion graft group, the shrinkage was significantly greater with 30.10 ± 16.12, 36.99 ± 15.51, and 43.75 ± 18.78 percent at 1, 3, and 6 months, respectively (p-value < .001). Other factors did not show a clinically significant difference between the two groups.
CONCLUSIONS


Comparison of vertical shrinkage changes shows that the shrinkage rate in the accordion group is significantly higher than the conventional group.
REGISTRATION NUMBER


IRCT20190721044296N1 (Evaluation of dimensional changes of peri-implant attached mucosa following the treatment of free gingival graft by conventional and accordion methods; randomized clinical trial two-arm parallel).",2022,"The graft harvesting and recipient bed preparation method were similar in the two groups, and the only difference was the graft length.","['Ninety-four implants with keratinized tissue deficiency (< 2mm', 'keratinized mucosa after accordion versus conventional free gingival graft around dental implants']","['FGG', 'accordion (49 implants) and conventional (45 implants) FGG']","['graft length', 'shrinkage', 'shrinkage rate', 'apico-coronal keratinized tissue width, vertical shrinkage, vestibular depth, probing depth, bleeding on probing, and plaque index']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0398967', 'cui_str': 'Free soft dentoalveolar tissue graft procedure, including donor site'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}]","[{'cui': 'C0398967', 'cui_str': 'Free soft dentoalveolar tissue graft procedure, including donor site'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]",94.0,0.0595231,"The graft harvesting and recipient bed preparation method were similar in the two groups, and the only difference was the graft length.","[{'ForeName': 'Niusha', 'Initials': 'N', 'LastName': 'Namadmalian Esfahani', 'Affiliation': 'Periodontics Department, School of Dentistry, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Seyed Hossein', 'Initials': 'SH', 'LastName': 'Mohseni Salehi Monfared', 'Affiliation': 'Periodontics Department, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Khorsand', 'Affiliation': 'Periodontics Department, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad Reza', 'Initials': 'AR', 'LastName': 'Shamshiri', 'Affiliation': 'Research Center for Caries Prevention, Dentistry Research Institute, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}]",Clinical oral implants research,['10.1111/clr.13907']
2222,35192640,Effect of integrated reproductive health lesson materials in a problem-based pedagogy on soft skills for safe sexual behaviour among adolescents: A school-based randomized controlled trial in Tanzania.,"BACKGROUND


Adolescents are currently becoming sexually active before their 18th birthday during which they have to battle with unsafe sexual behaviours, teenage pregnancies, sexually transmitted infections (STIs), and school dropouts. The trend is linked with low soft skills (self-esteem and assertiveness skills) for them to make informed, reasoned, and responsible decisions over sexual activities. This study designed and tested the effect of integrated reproductive health (RH) lesson materials in a problem-based pedagogy (PBP) to enhance soft skills for safe sexual behaviour among adolescents in Tanzania.
METHODS


A double-blinded clustered randomized controlled trial was conducted between September 2019 and September 2020 among 660 randomly selected adolescents. A Sexual-risk Behaviour Beliefs and Self-esteem Scale adopted from previous studies measured soft skills for safe sexual behaviour. A descriptive statistical analysis was performed by using the statistical analysis software programme version 9.4. The effect of the intervention was determined using Linear Mixed Model set at α error probability = 5% significance level (95% confidence interval) and a β error probability = 0.80.
FINDINGS


Adolescents' mean age was 15±1.869 with 57.5% females. The end-line findings indicated that the coefficient of soft skills was significantly higher among adolescents in the hybrid PBP (β=9.0986, p<0.01; 95%CI: 4.7772, 14.2311) and pure PBP (β =8.7114, p<0.01; 95%CI: 3.9990, 10.1208) than in the control group. The retention rate of soft skills was still significantly higher at 3-months follow-up (β=2.0044; p<0.01; 95%CI: 1.0234, 4.1182) and at 6-months follow-up (β=1.9803; p<0.01; 95%CI: 0.8399, 3.1099) compared to the baseline and immediate post-intervention assessments.
CONCLUSION


The intervention substantially enhanced soft skills for safe sexual behaviour among adolescents of both sex. Despite the fact that scores for soft skills varied across the study timelines, adolescents demonstrated significant intentions to abstain from sexual intercourse, delay sexual relationships, negotiate condom use, and withstand sexual coercions. The PBP may need to be incorporated in ordinary level secondary school curricula as a formal guide to teachers and or health workers to optimally prepare adolescents for their healthy adulthood.",2022,"The retention rate of soft skills was still significantly higher at 3-months follow-up (β=2.0044; p<0.01; 95%CI: 1.0234, 4.1182) and at 6-months follow-up (β=1.9803; p<0.01; 95%CI: 0.8399, 3.1099) compared to the baseline and immediate post-intervention assessments.
","['adolescents of both sex', 'adolescents', ""Adolescents' mean age was 15±1.869 with 57.5% females"", 'adolescents in Tanzania', 'September 2019 and September 2020 among 660 randomly selected adolescents']","['integrated reproductive health (RH) lesson materials', 'integrated reproductive health lesson materials', '95%CI', 'intervention substantially enhanced soft skills']","['retention rate of soft skills', 'coefficient of soft skills']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C4517845', 'cui_str': '660'}]","[{'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205358', 'cui_str': 'Soft'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205358', 'cui_str': 'Soft'}]",660.0,0.116286,"The retention rate of soft skills was still significantly higher at 3-months follow-up (β=2.0044; p<0.01; 95%CI: 1.0234, 4.1182) and at 6-months follow-up (β=1.9803; p<0.01; 95%CI: 0.8399, 3.1099) compared to the baseline and immediate post-intervention assessments.
","[{'ForeName': 'Walter C', 'Initials': 'WC', 'LastName': 'Millanzi', 'Affiliation': 'Department of Nursing Management and Education, School of Nursing and Public Health, The University of Dodoma, Dodoma, Tanzania.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Kibusi', 'Affiliation': 'Department of Public Health, School of Nursing and Public Health, The University of Dodoma, Dodoma, Tanzania.'}, {'ForeName': 'Kalafunja M', 'Initials': 'KM', 'LastName': 'Osaki', 'Affiliation': 'Centre for Pedagogy, Education, Development, Writing and Editing Documents, St. Augustine University of Tanzania, Mwanza, Tanzania.'}]",PloS one,['10.1371/journal.pone.0263431']
2223,35193044,Acute stress reactivity and intrusive memory development: a randomized trial using an adjusted trauma film paradigm.,"Understanding the neurobiological and cognitive processes underlying the development of posttraumatic stress disorder (PTSD) and its specific symptoms may facilitate preventive intervention development. Severe traumatic stress and resulting biological stress system activations can alter contextual memory processes. This may provide a neurobiological explanation for the occurrence of intrusive memories following trauma. Investigating the associations between temporal aspects and individual variation in peri- and post-traumatic hypothalamic pituitary adrenal (HPA) axis and sympathetic nervous system (SNS) stress reactivity and memory processing may increase our understanding of intrusive symptom development. The experimental trauma film paradigm is commonly used for this purpose but lacks robust SNS and HPA axis activation. Here, we performed an RCT to investigate the effect of an adjusted trauma film paradigm containing an added brief psychosocial stressor on HPA and SNS stress reactivity throughout the experiment and intrusive memory frequency in the following week in healthy males (N = 63, mean age = 22.3). Secondary, we investigated effects on film-related declarative memory accuracy and intrusion-related characteristics, and associations between acute HPA and SNS stress reactivity, film-related memory, glucocorticoid receptor functioning and intrusion frequency and characteristics. Participants were randomized to the socially-evaluated cold pressor test (seCPT n = 29) or control condition (warm water n = 34) immediately prior to a trauma film. Linear Mixed Models revealed increased acute SNS and cortisol reactivity, lower recognition memory accuracy and more intrusions that were more vivid and distressing during the following week in the seCPT compared to control condition. Linear regression models revealed initial associations between cortisol and alpha amylase reactivity during the experimental assessment and subsequent intrusions, but these effects did not survive multiple comparison corrections. Thus, with this adjustment, we increased the translational value of the trauma film paradigm as it appears to elicit a stronger stress response that is likely more comparable to real-life trauma. The adapted paradigm may be useful to investigate individual variation in biological and cognitive processes underlying early post-trauma PTSD symptoms and could advance potential preventive interventions.",2022,"Linear Mixed Models revealed increased acute SNS and cortisol reactivity, lower recognition memory accuracy and more intrusions that were more vivid and distressing during the following week in the seCPT compared to control condition.","['healthy males (N\xa0=\xa063, mean age\xa0=\xa022.3']","['socially-evaluated cold pressor test (seCPT n\xa0=\xa029) or control condition (warm water n\xa0=\xa034) immediately prior to a trauma film', 'seCPT']","['acute SNS and cortisol reactivity, lower recognition memory accuracy', 'film-related declarative memory accuracy and intrusion-related characteristics, and associations between acute HPA and SNS stress reactivity, film-related memory, glucocorticoid receptor functioning and intrusion frequency and characteristics', 'Acute stress reactivity and intrusive memory development', 'Severe traumatic stress']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0034809', 'cui_str': 'Glucocorticoid receptor'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}]",,0.0259034,"Linear Mixed Models revealed increased acute SNS and cortisol reactivity, lower recognition memory accuracy and more intrusions that were more vivid and distressing during the following week in the seCPT compared to control condition.","[{'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Hilberdink', 'Affiliation': 'Department of Psychiatry, Amsterdam Neuroscience, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: c.e.hilberdink@amsterdamumc.nl.'}, {'ForeName': 'S R de', 'Initials': 'SR', 'LastName': 'Rooij', 'Affiliation': 'Department of Epidemiology and Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: s.r.derooij@amsterdamumc.nl.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Olff', 'Affiliation': 'Department of Psychiatry, Amsterdam Neuroscience, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; ARQ, National Psychotrauma Centre, Diemen, The Netherlands. Electronic address: m.olff@amsterdamumc.nl.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Bosch', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands; Department of Medical Psychology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: j.a.bosch@uva.nl.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Zuiden', 'Affiliation': 'Department of Psychiatry, Amsterdam Neuroscience, Amsterdam UMC, location Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: m.vanzuiden@amsterdamumc.nl.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2022.105686']
2224,35193041,Screening for deficits on intrinsic capacity domains and associated healthcare costs.,"BACKGROUND/OBJECTIVE


Intrinsic capacity (IC) defined by the World Health Organization is divided into six domains (locomotion, psychological, vitality/nutrition, cognition, vision and hearing). The main objective of this study therefore is to explore the association between healthcare costs and IC domains deficits among older patients.
PARTICIPANTS AND SETTING


This longitudinal secondary analysis was performed on data from the Multidomain Alzheimer Preventive Trial (MAPT), a 3-year randomized controlled trial with non-demented community-dwelling participants aged 70 years or over.
METHODS


We used an adapted version of the ICOPE (Integrated Care for Older People) Step 1 to screen for the six operational IC domains deficits at three time-points: baseline, one year and two years. We performed bivariate and multivariate analyzes using generalized linear models and generalized estimating equation models to identify associations between healthcare cost and deficits on IC domains.
RESULTS


We analyzed 693 patients (aged 75.2 ± 4.22 years; 64% women (N = 442)). At baseline, among the included patients, 89% had at least one impairment in IC domains (N = 619). A deficit on visual capacity was associated with increased immediate healthcare costs (CR: 1.48; 95CI: [1.16-1.89]). Regarding persistent impairment of IC, locomotor (CR: 1.27; 95CI: [1.01-1.60], additional annual healthcare cost: €1092 per patient) and psychological (CR: 1.28; 95CI: [1.03-1.59], additional annual healthcare cost: €817 per patient) capacities were associated with increased healthcare costs.
CONCLUSION


In conclusion, this study showed that some deficits on IC domains, as measured by simple screening tests and questions, can be associated with higher healthcare costs. ClinicalTrials.gov identifier: NCT00672685.",2022,A deficit on visual capacity was associated with increased immediate healthcare costs (CR: 1.48; 95CI: [1.16-1.89]).,"['693 patients (aged 75.2\xa0±\xa04.22 years; 64% women (N\xa0=\xa0442', 'non-demented community-dwelling participants aged 70 years or over', 'for Older People', 'older patients']",['ICOPE (Integrated Care'],"['healthcare costs', 'immediate healthcare costs', 'visual capacity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",,0.273682,A deficit on visual capacity was associated with increased immediate healthcare costs (CR: 1.48; 95CI: [1.16-1.89]).,"[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Pagès', 'Affiliation': 'Department of Pharmacy, Hôpital Paule de Viguier, CHU de Toulouse, 330, avenue de Grande Bretagne - TSA 7003431059 Cedex 9, Toulouse, France; Gérontopôle, Institute of Aging, CHU de Toulouse, INSPIRE Project, Toulouse, France; CERPOP, UMR 1295, Université de Toulouse, Inserm, Université Paul Sabatier, Toulouse, France. Electronic address: pages.ar@chu-toulouse.fr.'}, {'ForeName': 'Nadège', 'Initials': 'N', 'LastName': 'Costa', 'Affiliation': 'CERPOP, UMR 1295, Université de Toulouse, Inserm, Université Paul Sabatier, Toulouse, France; Economic Evaluation Unit, Medical Information Department, CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'González-Bautista', 'Affiliation': 'Gérontopôle, Institute of Aging, CHU de Toulouse, INSPIRE Project, Toulouse, France; CERPOP, UMR 1295, Université de Toulouse, Inserm, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Mounié', 'Affiliation': 'CERPOP, UMR 1295, Université de Toulouse, Inserm, Université Paul Sabatier, Toulouse, France; Economic Evaluation Unit, Medical Information Department, CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Blandine', 'Initials': 'B', 'LastName': 'Juillard-Condat', 'Affiliation': 'Department of Pharmacy, Hôpital Paule de Viguier, CHU de Toulouse, 330, avenue de Grande Bretagne - TSA 7003431059 Cedex 9, Toulouse, France; CERPOP, UMR 1295, Université de Toulouse, Inserm, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Molinier', 'Affiliation': 'CERPOP, UMR 1295, Université de Toulouse, Inserm, Université Paul Sabatier, Toulouse, France; Economic Evaluation Unit, Medical Information Department, CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cestac', 'Affiliation': 'Department of Pharmacy, Hôpital Paule de Viguier, CHU de Toulouse, 330, avenue de Grande Bretagne - TSA 7003431059 Cedex 9, Toulouse, France; CERPOP, UMR 1295, Université de Toulouse, Inserm, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gérontopôle, Institute of Aging, CHU de Toulouse, INSPIRE Project, Toulouse, France; CERPOP, UMR 1295, Université de Toulouse, Inserm, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle, Institute of Aging, CHU de Toulouse, INSPIRE Project, Toulouse, France; CERPOP, UMR 1295, Université de Toulouse, Inserm, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Philipe', 'Initials': 'P', 'LastName': 'De Souto Barreto', 'Affiliation': 'Gérontopôle, Institute of Aging, CHU de Toulouse, INSPIRE Project, Toulouse, France; CERPOP, UMR 1295, Université de Toulouse, Inserm, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2022.104654']
2225,35195519,A rapid intrapartum test for group B Streptococcus to reduce antibiotic usage in mothers with risk factors: the GBS2 cluster RCT.,"BACKGROUND


Mother-to-baby transmission of group B  Streptococcus  ( Streptococcus agalactiae ) is the main cause of early-onset infection.
OBJECTIVES


We investigated if intrapartum antibiotic prophylaxis directed by a rapid intrapartum test reduces maternal and neonatal antibiotic use, compared with usual care (i.e. risk factor-directed antibiotics), among women with risk factors for vertical group B  Streptococcus  transmission, and examined the accuracy and cost-effectiveness of the rapid test.
DESIGN


An unblinded cluster randomised controlled trial with a nested test accuracy study, an economic evaluation and a microbiology substudy.
SETTING


UK maternity units were randomised to either a strategy of rapid test or usual care.
PARTICIPANTS


Vaginal and rectal swabs were taken from women with risk factors for vertical group B  Streptococcus  transmission in established term labour. The accuracy of the GeneXpert ®  Dx IV GBS rapid testing system (Cepheid, Maurens-Scopont, France) was compared with the standard of selective enrichment culture in diagnosing maternal group B  Streptococcus  colonisation.
MAIN OUTCOME MEASURES


Primary outcomes were rates of intrapartum antibiotic prophylaxis administered to prevent early-onset group B  Streptococcus  infection and accuracy estimates of the rapid test. Secondary outcomes were maternal antibiotics for any indication, neonatal antibiotic exposure, maternal antibiotic duration, neonatal group B  Streptococcus  colonisation, maternal and neonatal antibiotic resistance, neonatal morbidity and mortality, and cost-effectiveness of the strategies.
RESULTS


Twenty-two maternity units were randomised and 20 were recruited. A total of 722 mothers (749 babies) participated in rapid test units and 906 mothers (951 babies) participated in usual-care units. There were no differences in the rates of intrapartum antibiotic prophylaxis for preventing early-onset group B  Streptococcus  infection in the rapid test units (41%, 297/716) compared with the usual-care units (36%, 328/906) (risk ratio 1.16, 95% confidence interval 0.83 to 1.64). There were no differences between the groups in intrapartum antibiotic administration for any indication (risk ratio 0.99, 95% confidence interval 0.81 to 1.21). Babies born in the rapid test units were 29% less likely to receive antibiotics (risk ratio 0.71, 95% confidence interval 0.54 to 0.95) than those born in usual-care units. The sensitivity and specificity of the rapid test were 86% (95% confidence interval 81% to 91%) and 89% (95% confidence interval 85% to 92%), respectively. In 14% of women (99/710), the rapid test was invalid or the machine failed to provide a result. In the economic analysis, the rapid test was shown to be both less effective and more costly and, therefore, dominated by usual care. Sensitivity analysis indicated potential lower costs for the rapid test strategy when neonatal costs were included. No serious adverse events were reported.
CONCLUSIONS


The Group B Streptococcus 2 (GBS2) trial found no evidence that the rapid test reduces the rates of intrapartum antibiotic prophylaxis administered to prevent early-onset group B  Streptococcus  infection. The rapid test has the potential to reduce neonatal exposure to antibiotics, but economically is dominated by usual care. The accuracy of the test is within acceptable limits.
FUTURE WORK


The role of routine testing for prevention of neonatal infection requires evaluation in a randomised controlled trial.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN74746075.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 26, No. 12. See the NIHR Journals Library website for further project information.",2022,"Babies born in the rapid test units were 29% less likely to receive antibiotics (risk ratio 0.71, 95% confidence interval 0.54 to 0.95) than those born in usual-care units.","['Twenty-two maternity units were randomised and 20 were recruited', 'mothers with risk factors', 'Vaginal and rectal swabs were taken from women with risk factors for vertical group B  Streptococcus  transmission in established term labour', '722 mothers (749 babies) participated in rapid test units and 906 mothers (951 babies) participated in usual-care units', 'UK maternity units']",['rapid test or usual care'],"['sensitivity and specificity of the rapid test', 'rates of intrapartum antibiotic prophylaxis', 'maternal antibiotics for any indication, neonatal antibiotic exposure, maternal antibiotic duration, neonatal group B  Streptococcus  colonisation, maternal and neonatal antibiotic resistance, neonatal morbidity and mortality, and cost-effectiveness of the strategies', 'rates of intrapartum antibiotic prophylaxis administered to prevent early-onset group B  Streptococcus  infection and accuracy estimates of the rapid test', 'serious adverse events']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0444215', 'cui_str': 'Rectal swab'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0579233', 'cui_str': 'Streptococcus agalactiae'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0579233', 'cui_str': 'Streptococcus agalactiae'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.131487,"Babies born in the rapid test units were 29% less likely to receive antibiotics (risk ratio 0.71, 95% confidence interval 0.54 to 0.95) than those born in usual-care units.","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Emily F', 'Initials': 'EF', 'LastName': 'Dixon', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Gill', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Bishop', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""D'Amico"", 'Affiliation': ""Centre for Women's Health, Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dodds', 'Affiliation': ""Centre for Women's Health, Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Tryposkiadis', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wilks', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Millar', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Husain', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Gray', 'Affiliation': ""Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Whiley', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Patrick V', 'Initials': 'PV', 'LastName': 'Moore', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ruvimbo L', 'Initials': 'RL', 'LastName': 'Munetsi', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Roberts', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Plumb', 'Affiliation': 'Group B Strep Support, Haywards Heath, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Deeks', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Khalid S', 'Initials': 'KS', 'LastName': 'Khan', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Shakila', 'Initials': 'S', 'LastName': 'Thangaratinam', 'Affiliation': 'Institute of Metabolism and System Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/BICF1187']
2226,35196033,"Multilevel Intervention for Low-Income Maternal Smokers in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).","Objectives.  To test the efficacy of Babies Living Safe and Smokefree (BLiSS), a multilevel intervention initiated in a citywide safety net health system to improve low-income maternal smokers' abstinence and reduce child tobacco smoke exposure.  Methods.  This randomized controlled trial in Philadelphia, Pennsylvania (2015-2020), recruited low-income maternal smokers who received a brief smoking intervention (Ask, Advise, Refer [AAR]) from nutrition professionals in the Special Supplemental Nutrition Program for Women, Infants, and Children before randomization to (1) a multilevel intervention (AAR + multimodal behavioral intervention [MBI]; n = 199) or (2) an attention control intervention (AAR + control; n = 197).  Results.  AAR + MBI mothers had significantly higher 12-month bioverified abstinence rates than did AAR + control mothers (odds ratio [OR] = 9.55; 95% confidence interval [CI] = 1.54, 59.30;  P  = .015). There were significant effects of time (b = -0.15; SE = 0.04;  P  < .001) and condition by time (b = -0.19; SE = 0.06;  P  < .001) on reported child exposure favoring AAR + MBI, but no group difference in child cotinine. Presence of other residential smokers was related to higher exposure. Higher baseline nicotine dependence was related to higher child exposure and lower abstinence likelihood at follow-up.  Conclusions.  The multilevel BLiSS intervention was acceptable and efficacious in a population that experiences elevated challenges with cessation.  Public Health Implications.  BLiSS is a translatable intervention model that can successfully improve efforts to address the persistent tobacco-related burdens in low-income communities.  Trial Registration.  Clinical Trials.gov identifier: NCT02602288. ( Am J Public Health . 2022;112(3):472-481. https://doi.org/10.2105/AJPH.2021.306601).",2022,"AAR + MBI mothers had significantly higher 12-month bioverified abstinence rates than did AAR + control mothers (odds ratio [OR] = 9.55; 95% confidence interval [CI] = 1.54, 59.30;  P  = .015).","[""low-income maternal smokers' abstinence and reduce child tobacco smoke exposure"", 'Low-Income Maternal Smokers in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC', 'Philadelphia, Pennsylvania (2015-2020), recruited low-income maternal smokers who received a brief smoking intervention (Ask, Advise, Refer [AAR]) from nutrition professionals in the Special Supplemental Nutrition Program for Women, Infants, and Children before randomization to (1) a']","['Multilevel Intervention', 'multilevel intervention (AAR + multimodal behavioral intervention [MBI]; n\u2009=\u2009199) or (2) an attention control intervention (AAR + control; n\u2009=\u2009197', 'multilevel BLiSS intervention', 'BLiSS', 'Babies Living Safe and Smokefree (BLiSS']","['12-month bioverified abstinence rates', 'child cotinine']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0574156', 'cui_str': 'Afar language'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}]",,0.0908554,"AAR + MBI mothers had significantly higher 12-month bioverified abstinence rates than did AAR + control mothers (odds ratio [OR] = 9.55; 95% confidence interval [CI] = 1.54, 59.30;  P  = .015).","[{'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Collins', 'Affiliation': 'Bradley N. Collins and Stephen J. Lepore are with the Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, PA. Brian L. Egleston is with the Biostatistics and Bioinformatics Facility, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Lepore', 'Affiliation': 'Bradley N. Collins and Stephen J. Lepore are with the Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, PA. Brian L. Egleston is with the Biostatistics and Bioinformatics Facility, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Egleston', 'Affiliation': 'Bradley N. Collins and Stephen J. Lepore are with the Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, PA. Brian L. Egleston is with the Biostatistics and Bioinformatics Facility, Fox Chase Cancer Center, Philadelphia, PA.'}]",American journal of public health,['10.2105/AJPH.2021.306601']
2227,35196310,Virtually Augmented Self-Hypnosis applied to endovascular interventions (VA-HYPO): Randomized Controlled Trial Protocol.,"Endovascular interventions (EVI) are increasingly performed as minimally-invasive alternatives to surgery and have many advantages, including a decreased need for general anesthesia. However, EVI can be stressful for patients and often lead to anxiety and pain related to the procedure. The use of local anesthetics, anxiolytics, and analgesic drugs can help avoid general anesthesia. Nevertheless, these drugs have potential side effects. Alternative nonpharmacological therapies can improve patients' experience during conscious interventions and reduce the need for additional medications. The added value of virtually augmented self-hypnosis (VA-HYPO) and its potential to reduce pain and anxiety during peripheral and visceral arterial and venous EVI is unknown. This is a prospective two-arm trial designed to randomize 100 patients in two groups according to the use or not of VA-HYPO during peripheral EVI as a complementary nonpharmacological technique to improve patient comfort. The main objective is to compare per-procedural anxiety, and the secondary aim is to compare the rated per-procedural pain in both groups. The potential significance is that VA-HYPO may improve patients' experience during peripheral and visceral arterial and venous EVI and other minimally invasive interventions performed under local anesthesia. Trial registration: Our study is registered on clinicaltrials.gov, with trial registration number: NCT04561596.",2022,The added value of virtually augmented self-hypnosis (VA-HYPO) and its potential to reduce pain and anxiety during peripheral and visceral arterial and venous EVI is unknown.,['100 patients in two groups according to the use or not of VA-HYPO during peripheral EVI as a complementary nonpharmacological technique to improve patient comfort'],"['endovascular interventions (VA-HYPO', 'local anesthetics, anxiolytics, and analgesic drugs', 'Endovascular interventions (EVI']",['pain and anxiety'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0411282', 'cui_str': 'Endovascular radiological intervention'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}]","[{'cui': 'C0411282', 'cui_str': 'Endovascular radiological intervention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0517947,The added value of virtually augmented self-hypnosis (VA-HYPO) and its potential to reduce pain and anxiety during peripheral and visceral arterial and venous EVI is unknown.,"[{'ForeName': 'Salah D', 'Initials': 'SD', 'LastName': 'Qanadli', 'Affiliation': 'Cardiothoracic and Vascular Division, Department of Diagnostic and Interventional Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Gudmundsson', 'Affiliation': 'Cardiothoracic and Vascular Division, Department of Diagnostic and Interventional Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gullo', 'Affiliation': 'Cardiothoracic and Vascular Division, Department of Diagnostic and Interventional Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Ponti', 'Affiliation': 'Cardiothoracic and Vascular Division, Department of Diagnostic and Interventional Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saltiel', 'Affiliation': 'Cardiothoracic and Vascular Division, Department of Diagnostic and Interventional Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Jouannic', 'Affiliation': 'Cardiothoracic and Vascular Division, Department of Diagnostic and Interventional Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Faouzi', 'Affiliation': 'Center for Primary Care and Public Health (Unisanté), University of Lausanne, Epalinges, Switzerland.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Rotzinger', 'Affiliation': 'Cardiothoracic and Vascular Division, Department of Diagnostic and Interventional Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}]",PloS one,['10.1371/journal.pone.0263002']
2228,35196605,The approval and withdrawal of melphalan flufenamide (melflufen): Implications for the state of the FDA.,"In October 2021, melphalan flufenamide (melflufen) was withdrawn from the US market for the treatment of multiple myeloma. The decision occurred based on results from a phase 3 randomized controlled trial (RCT) which showed numerically inferior overall survival, which previously led the FDA to halt all trials involving this drug. We highlight four issues raised by the approval fate of melflufen. First, the OCEAN trial was designed with a substandard control arm: negative results occurred despite this bias theoretically favoring the experimental arm. Second, a new compound, derived from a well-known drug, is not well fitting the accelerated pathway principles, unless being robustly tested against its parent drug. Third and four, allowing a new compound on the market, while there are known alternatives, and imminent confirmatory data, has the potential to harm patients while bringing earlier market share and profit to the company. While the FDA and the company should be commended for pushing a potentially dangerous product off the US market despite recent approval, yet a re-evaluation of regulatory processes is needed to ensure that cancer patients have timely access to effective medications while being protected against potentially detrimental ones.",2022,"While the FDA and the company should be commended for pushing a potentially dangerous product off the US market despite recent approval, yet a re-evaluation of regulatory processes is needed to ensure that cancer patients have timely access to effective medications while being protected against potentially detrimental ones.",[],['melphalan flufenamide (melflufen'],[],[],"[{'cui': 'C1435749', 'cui_str': 'L-melphalanyl-p-L-fluorophenylalanine ethyl ester'}]",[],4.0,0.0956617,"While the FDA and the company should be commended for pushing a potentially dangerous product off the US market despite recent approval, yet a re-evaluation of regulatory processes is needed to ensure that cancer patients have timely access to effective medications while being protected against potentially detrimental ones.","[{'ForeName': 'Timothée', 'Initials': 'T', 'LastName': 'Olivier', 'Affiliation': 'Department of Oncology, Geneva University Hospital, 4 Gabrielle-Perret-Gentil Street, 1205, Geneva, Switzerland; Department of Epidemiology and Biostatistics, University of California San Francisco, 550 16th St, 2nd Fl, San Francisco, CA 94158, USA. Electronic address: Timothee.olivier@hcuge.ch.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Prasad', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, 550 16th St, 2nd Fl, San Francisco, CA 94158, USA.'}]",Translational oncology,['10.1016/j.tranon.2022.101374']
2229,35197189,Structured Delirium Management in the Hospital–a Randomized Controlled Trial.,"BACKGROUND


Delirium is a common and serious complication of inpatient hospital care in elderly patients. The current prevention and treatment concepts followed in German hospitals are inconsistent. The aim of this study was to test the effectiveness of a standardized multiprofessional approach to the management of delirium in inpatients.
METHODS


The patients included in the study were all >65 years old, were treated for at least 3 days on an internal medicine, trauma surgery or orthopedic ward at University Hospital Münster between January 2016 and December 2017, and showed cognitive deficits on standardized screening at the time of admission (a score of ≤ 25 on the Montreal Cognitive Assessment [MoCA] test). Patients in the intervention group received standardized delirium prevention and treatment measures; those in the control group did not. The primary outcomes measured were the rate and duration of delirium during the hospital stay; the secondary outcomes measured were cognitive deficits relevant to daily living at 12 months after discharge (MoCA and Instrumental Activities of Daily Living [I-ADL]).
RESULTS


The data of 772 patients were analyzed. Both the rate and the duration of delirium were lower in the intervention group than in the control group (6.8% versus 20.5%, odds ratio 0.28, 95% confidence interval [0.18; 0.45]; 3 days [interquartile range, IQR 2-4] versus 6 days [IQR 4-8]). A year after discharge, the delirium patients in the intervention group showed fewer cognitive deficits relevant to daily living than those in the control group (I-ADL score 2.5 [IQR 2-4] versus 1 [IQR 1-2], p = 0.02).
CONCLUSION


Structured multiprofessional management reduces the rate and duration of delirium and lowers the number of lasting cognitive deficits relevant to daily living after hospital discharge.",2022,"Both the rate and the duration of delirium were lower in the intervention group than in the control group (6.8% versus 20.5%, odds ratio 0.28, 95% confidence interval [0.18; 0.45]; 3 days [interquartile range, IQR 2-4] versus 6 days [IQR 4-8]).","['elderly patients', '772 patients were analyzed', 'patients included in the study were all >65 years old, were treated for at least 3 days on an internal medicine, trauma surgery or orthopedic ward at University Hospital Münster between January 2016 and December 2017, and showed cognitive deficits on standardized screening at the time of admission (a score of ≤ 25 on the Montreal Cognitive Assessment [MoCA] test', 'delirium in inpatients']","['standardized multiprofessional approach', 'standardized delirium prevention']","['cognitive deficits relevant to daily living', 'rate and duration of delirium', 'rate and the duration of delirium', 'rate and duration of delirium during the hospital stay; the secondary outcomes measured were cognitive deficits relevant to daily living at 12 months after discharge (MoCA and Instrumental Activities of Daily Living [I-ADL']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",772.0,0.215579,"Both the rate and the duration of delirium were lower in the intervention group than in the control group (6.8% versus 20.5%, odds ratio 0.28, 95% confidence interval [0.18; 0.45]; 3 days [interquartile range, IQR 2-4] versus 6 days [IQR 4-8]).","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Krämer', 'Affiliation': ''}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Nolte', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zupanc', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schnitker', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Roos', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Göpel', 'Affiliation': ''}, {'ForeName': 'Janina Santos', 'Initials': 'JS', 'LastName': 'Cid', 'Affiliation': ''}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Eichler', 'Affiliation': ''}, {'ForeName': 'Thomas van den', 'Initials': 'TVD', 'LastName': 'Hooven', 'Affiliation': ''}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Hempel', 'Affiliation': ''}, {'ForeName': 'Hermann-Joseph', 'Initials': 'HJ', 'LastName': 'Pavenstädt', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Klaas', 'Affiliation': ''}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Gosheger', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Raschke', 'Affiliation': ''}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Wiendl', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Duning', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.m2022.0131']
2230,35186675,Urinary Metabolomic Changes Accompanying Albuminuria Remission following Gastric Bypass Surgery for Type 2 Diabetic Kidney Disease.,"In the Microvascular Outcomes after Metabolic Surgery randomised clinical trial (MOMS RCT, NCT01821508), combined metabolic surgery (gastric bypass) plus medical therapy (CSM) was superior to medical therapy alone (MTA) as a means of achieving albuminuria remission at 2-year follow-up in patients with obesity and early diabetic kidney disease (DKD). In the present study, we assessed the urinary  1 H-NMR metabolome in a subgroup of patients from both arms of the MOMS RCT at baseline and 6-month follow-up. Whilst CSM and MTA both reduced the urinary excretion of sugars, CSM generated a distinctive urinary metabolomic profile characterised by increases in host-microbial co-metabolites (N-phenylacetylglycine, trimethylamine N-oxide, and 4-aminobutyrate (GABA)) and amino acids (arginine and glutamine). Furthermore, reductions in aromatic amino acids (phenylalanine and tyrosine), as well as branched-chain amino acids (BCAAs) and related catabolites (valine, leucine, 3-hydroxyisobutyrate, 3-hydroxyisovalerate, and 3-methyl-2-oxovalerate), were observed following CSM but not MTA. Improvements in BMI did not correlate with improvements in metabolic and renal indices following CSM. Conversely, urinary metabolites changed by CSM at 6 months were moderately to strongly correlated with improvements in blood pressure, glycaemia, triglycerides, and albuminuria up to 24 months following treatment initiation, highlighting the potential involvement of these shifts in the urinary metabolomic profile in the metabolic and renoprotective effects of CSM.",2022,"Whilst CSM and MTA both reduced the urinary excretion of sugars, CSM generated a distinctive urinary metabolomic profile characterised by increases in host-microbial co-metabolites (N-phenylacetylglycine, trimethylamine N-oxide, and 4-aminobutyrate (GABA)) and amino acids (arginine and glutamine).","['Type 2 Diabetic Kidney Disease', 'patients with obesity and early diabetic kidney disease (DKD']","['Gastric Bypass Surgery', 'medical therapy alone (MTA', 'combined metabolic surgery (gastric bypass) plus medical therapy (CSM']","['BMI', 'metabolic and renal indices', 'blood pressure, glycaemia, triglycerides, and albuminuria', 'host-microbial co-metabolites (N-phenylacetylglycine, trimethylamine N-oxide, and 4-aminobutyrate (GABA)) and amino acids (arginine and glutamine', 'urinary metabolites', 'aromatic amino acids (phenylalanine and tyrosine', 'albuminuria remission']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4521841', 'cui_str': 'US Military enlisted E9'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0451416', 'cui_str': 'Renal index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0070628', 'cui_str': 'phenylacetylglycine'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0178649', 'cui_str': 'gamma-Aminobutyrate'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0301713', 'cui_str': 'Aromatic amino acid'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.109673,"Whilst CSM and MTA both reduced the urinary excretion of sugars, CSM generated a distinctive urinary metabolomic profile characterised by increases in host-microbial co-metabolites (N-phenylacetylglycine, trimethylamine N-oxide, and 4-aminobutyrate (GABA)) and amino acids (arginine and glutamine).","[{'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Martin', 'Affiliation': 'Diabetes Complications Research Centre, School of Medicine, Conway Institute of Biomolecular and Biomedical Research, University College Dublin, Belfield, D04 V1W8 Dublin, Ireland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Malmodin', 'Affiliation': 'Swedish NMR Centre, University of Gothenburg, 40530 Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Pedersen', 'Affiliation': 'Swedish NMR Centre, University of Gothenburg, 40530 Gothenburg, Sweden.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'Institute of Food and Health, School of Agriculture and Food Science, University College Dublin, Belfield, D04 V1W8 Dublin, Ireland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Fändriks', 'Affiliation': 'Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, 40530 Gothenburg, Sweden.'}, {'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Aboud', 'Affiliation': 'The Centre for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo 01333-010, Brazil.'}, {'ForeName': 'Tarissa B Zanata', 'Initials': 'TBZ', 'LastName': 'Petry', 'Affiliation': 'The Centre for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo 01333-010, Brazil.'}, {'ForeName': 'Lívia P', 'Initials': 'LP', 'LastName': 'Cunha da Silveira', 'Affiliation': 'The Centre for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo 01333-010, Brazil.'}, {'ForeName': 'Ana C Calmon', 'Initials': 'ACC', 'LastName': 'da Costa Silva', 'Affiliation': 'The Centre for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo 01333-010, Brazil.'}, {'ForeName': 'Ricardo V', 'Initials': 'RV', 'LastName': 'Cohen', 'Affiliation': 'The Centre for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo 01333-010, Brazil.'}, {'ForeName': 'Carel W', 'Initials': 'CW', 'LastName': 'le Roux', 'Affiliation': 'Diabetes Complications Research Centre, School of Medicine, Conway Institute of Biomolecular and Biomedical Research, University College Dublin, Belfield, D04 V1W8 Dublin, Ireland.'}, {'ForeName': 'Neil G', 'Initials': 'NG', 'LastName': 'Docherty', 'Affiliation': 'Diabetes Complications Research Centre, School of Medicine, Conway Institute of Biomolecular and Biomedical Research, University College Dublin, Belfield, D04 V1W8 Dublin, Ireland.'}]",Metabolites,['10.3390/metabo12020139']
2231,35187383,Circulating Liver-enriched Antimicrobial Peptide-2 Decreases During Male Puberty.,"Context


Circulating levels of liver-enriched antimicrobial peptide 2 (LEAP2), a ghrelin receptor antagonist, decrease under caloric restriction and increase in obesity. The role of LEAP2 in male puberty, a phase with accelerated energy demand, is unclear.
Objective


This work aimed to investigate whether circulating LEAP2 levels are downregulated in boys following the onset of puberty to respond to the energy need required for growth.
Methods


We determined circulating LEAP2 levels in 28 boys with constitutional delay of growth and puberty (CDGP) who participated in a randomized controlled trial (NCT01797718), and were treated with letrozole (n = 15) or intramuscular low-dose testosterone (T) (n = 13) for 6 months. Blood sampling and dual-energy x-ray absorptiometry-measured body composition were performed at 0-, 6-, and 12-month visits.
Results


Serum LEAP2 levels decreased statistically significantly during pubertal progression (0-6 months: mean decrease -4.3 [10.3] ng/mL,  P  = .036 and 0-12 months: -3.9 [9.3] ng/mL,  P  = .033). Between 0 and 6 months, the changes in serum LEAP2 levels correlated positively with changes in percentage of body fat ( r   s  = 0.48,  P  = .011), and negatively with growth velocity and estradiol levels ( r   s  = -0.43,  P  = .022,  r   s  = -0.55,  P  = .003, respectively). In the T group only, the changes in serum LEAP2 correlated negatively with changes in T and estradiol levels. Between 0 and 12 months, the change in LEAP2 levels correlated negatively with the change in high-density lipoprotein levels ( r   s  = -0.44,  P  = .022) and positively with the change in insulin ( r   s  = 0.50,  P  = .009) and HOMA-IR (r s  = 0.51,  P  = .007) levels.
Conclusion


Circulating LEAP2 levels decreased after induction of puberty reciprocally with increased growth rate and energy demand, reflecting the metabolic state of the adolescent. Further, the results suggest that estradiol levels may have a permissive role in downregulating circulating LEAP2 levels.",2022,"0-12 months: -3.9 [9.3] ng/mL,  P  = .033).","['28 boys with constitutional delay of growth and puberty (CDGP', 'male puberty']","['letrozole (n\u2005=\u200515) or intramuscular low-dose testosterone (T', 'LEAP2']","['Blood sampling and dual-energy x-ray absorptiometry-measured body composition', 'HOMA-IR', 'LEAP2 levels', 'changes in serum', 'T and estradiol levels', 'Circulating LEAP2 levels', 'change in LEAP2 levels', 'growth velocity and estradiol levels', 'circulating LEAP2 levels', 'percentage of body fat', 'high-density lipoprotein levels', 'serum LEAP2', 'change in insulin']","[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0342538', 'cui_str': 'Constitutional delay of growth and puberty'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}]","[{'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",28.0,0.0275338,"0-12 months: -3.9 [9.3] ng/mL,  P  = .033).","[{'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Varimo', 'Affiliation': ""New Children's Hospital, Helsinki University Hospital, Pediatric Research Center, FI-00029 HUS, Finland.""}, {'ForeName': 'Päivi J', 'Initials': 'PJ', 'LastName': 'Miettinen', 'Affiliation': ""New Children's Hospital, Helsinki University Hospital, Pediatric Research Center, FI-00029 HUS, Finland.""}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Vaaralahti', 'Affiliation': 'Stem Cells and Metabolism Research Program, Research Programs Unit, Faculty of Medicine, University of Helsinki, Helsinki FI-00014, Finland.'}, {'ForeName': 'Jorma', 'Initials': 'J', 'LastName': 'Toppari', 'Affiliation': 'Institute of Biomedicine, Research Centre for Integrative Physiology and Pharmacology, and Centre for Population Health Research, University of Turku, FI-20014 Turku, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Huopio', 'Affiliation': 'Kuopio University Hospital, University of Eastern Finland, FI-70210 Kuopio, Finland.'}, {'ForeName': 'Raimo', 'Initials': 'R', 'LastName': 'Voutilainen', 'Affiliation': 'Kuopio University Hospital, University of Eastern Finland, FI-70210 Kuopio, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Tenhola', 'Affiliation': 'Kymenlaakso Central Hospital, FI-48210 Kotka, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Hero', 'Affiliation': ""New Children's Hospital, Helsinki University Hospital, Pediatric Research Center, FI-00029 HUS, Finland.""}, {'ForeName': 'Taneli', 'Initials': 'T', 'LastName': 'Raivio', 'Affiliation': ""New Children's Hospital, Helsinki University Hospital, Pediatric Research Center, FI-00029 HUS, Finland.""}]",Journal of the Endocrine Society,['10.1210/jendso/bvac013']
2232,35187781,"A randomized, controlled, split-face study of botulinum toxin and broadband light for the treatment of erythematotelangiectatic rosacea.","To study the efficacy and safety of botulinum toxin (BTX) combined with broadband light (BBL) in the treatment of rosacea-related erythema and flushing. A randomized, single-blind, split-face controlled study including 22 patients with erythemato telangiectatic rosacea were enrolled. Both cheeks were randomly divided into experimental group and control group. They were treated three times with an interval of 1 month. In the first treatment, the experimental group received BBL treatment and intradermal injection of BTX, and the control group received BBL treatment and intradermal injection of the same amount of normal saline; in the second and third treatments were both groups received the same BBL treatment. The patients were evaluated before the first treatment and 1, 2, 3, and 6 months after the treatment. Compared with the control group, the hydration in the experimental group increased and the global flushing symptom score (GFSS), VISIA red value, erythema index, transepidermal water loss, and sebum secretion decreased. The differences were statistically significant (p < 0.05). In the experimental group, at 3 months after the first treatment, compared with before treatment, the GFSS, VISIA red value, erythema index, transepidermal water loss and sebum secretion decreased the hydration increased. The sebum secretion returned to the pretreatment level in 6 months after treatment, and the other indexes maintained the level in 3 months after treatment. One patient had a slight lifting limitation of the corners of his mouth after 10 days of BTX injection, without special treatment, and recovered after 1 month. BTX intradermal injection combined with BBL has a definite therapeutic effect on the improvement of rosacea related erythema and flushing, which is better than simple BBL, and has high safety. It is worthy of clinical promotion.",2022,"Compared with the control group, the hydration in the experimental group increased and the Global Flushing Symptom Score, VISIA red value, erythema index, Transepidermal water loss and sebum secretion decreased.","['Erythemato telangiectatic rosacea', 'rosacea related erythema and flushing', '22 patients with erythematotelangiectatic rosacea were enrolled']","['botulinum toxin injection', 'Botulinum toxin and broadband light', 'Botulinum toxin intradermal injection combined with broadband light', 'same broadband light treatment', 'broadband light treatment and intradermal injection of botulinum toxin, and the control group received broadband light treatment and intradermal injection of the same amount of normal saline', 'botulinum toxin (BTX) combined with broadband light (BBL']","['sebum secretion', 'Global Flushing Symptom Score, VISIA red value, erythema index, Transepidermal water loss and sebum secretion']","[{'cui': 'C0035854', 'cui_str': 'Rosacea'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1449852', 'cui_str': 'Acne rosacea, erythematous telangiectatic type'}]","[{'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0232436', 'cui_str': 'Sebaceous gland activity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]",22.0,0.029595,"Compared with the control group, the hydration in the experimental group increased and the Global Flushing Symptom Score, VISIA red value, erythema index, Transepidermal water loss and sebum secretion decreased.","[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': ""Department of Medical Cosmetology, Chengdu Second People's Hospital, Chengdu, China.""}, {'ForeName': 'Wangsha', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': ""Department of Dermatology, Chengdu Fifth People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Yulian', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Department of Medical Cosmetology, Chengdu Second People's Hospital, Chengdu, China.""}, {'ForeName': 'Lufeng', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Medical Cosmetology, Chengdu Second People's Hospital, Chengdu, China.""}, {'ForeName': 'Qiuyue', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': ""Department of Medical Cosmetology, Chengdu Second People's Hospital, Chengdu, China.""}, {'ForeName': 'Qingbiao', 'Initials': 'Q', 'LastName': 'Wa', 'Affiliation': ""Department of Medical Cosmetology, Chengdu Second People's Hospital, Chengdu, China.""}]",Dermatologic therapy,['10.1111/dth.15395']
2233,35189449,Evaluation of the effects of different rapid maxillary expansion appliances on airway by acoustic rhinometry: A randomized clinical trial.,"OBJECTIVE


The purpose of this 3-arm parallel trial was to compare the effects of tooth tissue-borne (TTB), tooth-borne (TB) and bone-borne (BB) rapid maxillary expansion (RME) appliances on nasal airway with acoustic rhinometry (AR).
SETTING AND SAMPLE POPULATION


Forty-six 12- to 14-year-old patients with narrow maxilla were randomly allocated into 3 study groups accordingly the type of expander: TTB, TB and BB. The participants were recruited from the Department of Orthodontics, Izmir Katip Celebi University.
MATERIALS AND METHODS


All patients had RME with an initial activation of two-quarter turns a day (0.5 mm) for an average of 8 days followed by 1 quarter turns per day for an average of 10 days. Disguised group allocation using opaque sealed envelopes was made with a computer-generated randomization program. The primary outcome was changes on the minimal nasal cross-sectional area (MCA). Secondary outcome included the assessment of nasal cavity volume. AR measurements were obtained at baseline (T0), immediately after the expansion (T1), and at 3 months-follow-up (T2). One-way analysis of variance (ANOVA) and Bonferroni test were used for inter-group comparison and two-way ANOVA was used for intra-group evaluation.
RESULTS


There were significant increases in MCA 1, 2 and nasal Vol in all groups after the treatment (95% [CI], P < 0.05) whereas in inter-group comparisons; MCA 1, 2 and nasal Vol, the changes were found to be similar (95% [CI], P > 0.05).
HARMS


No serious harm was observed except for mild gingivitis due to plaque accumulation.
CONCLUSIONS


RME treatment increased minimal nasal cross-sectional areas and nasal volume irrespective of appliance design.
TRIAL REGISTRATION


This trial was registered at Clinicaltrials.gov (Identifier NCT04529057).
PROTOCOL


The protocol was not published.
FUNDING


This trial was financed by Izmir Katip Celebi University, Scientific Research Projects Unit [grant number 2016-TDR-SABE-0024].",2022,"There were significant increases in MCA 1, 2 and nasal Vol in all groups after the treatment (95% [CI], P < 0.05) whereas in inter-group comparisons; MCA 1, 2 and nasal Vol, the changes were found to be similar (95% [CI], P > 0.05).
","['Forty-six 12- to 14-year-old patients with narrow maxilla', 'All patients had RME with an initial activation of two-quarter turns a day (0.5\xa0mm) for an average of 8 days followed by 1 quarter turns per day for an average of 10 days', 'participants were recruited from the Department of Orthodontics, Izmir Katip Celebi University']","['tooth tissue-borne (TTB), tooth-borne (TB) and bone-borne (BB) rapid maxillary expansion (RME) appliances', 'rapid maxillary expansion appliances', 'RME']","['minimal nasal cross-sectional areas and nasal volume', 'AR measurements', 'minimal nasal cross-sectional area (MCA', 'MCA 1, 2 and nasal Vol', 'assessment of nasal cavity volume', 'nasal airway with acoustic rhinometry (AR']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0441424', 'cui_str': 'Rapid maxillary expansion appliance'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0430619', 'cui_str': 'Acoustic rhinometry'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027423', 'cui_str': 'Nasal cavity structure'}, {'cui': 'C0150683', 'cui_str': 'Nasopharyngeal airway device'}]",,0.0679643,"There were significant increases in MCA 1, 2 and nasal Vol in all groups after the treatment (95% [CI], P < 0.05) whereas in inter-group comparisons; MCA 1, 2 and nasal Vol, the changes were found to be similar (95% [CI], P > 0.05).
","[{'ForeName': 'Gokcenur', 'Initials': 'G', 'LastName': 'Gokce', 'Affiliation': 'Izmir Katip Celebi University, Faculty of Dentistry, Department of Orthodontics, Turkey. Electronic address: dtggokce@gmail.com.'}, {'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Gode', 'Affiliation': 'Department of Otolaryngology, Ege University School of Medicine, Turkey. Electronic address: sercan.gode@icloud.com.'}, {'ForeName': 'Arın', 'Initials': 'A', 'LastName': 'Ozturk', 'Affiliation': 'Department of Otolaryngology, Ege University School of Medicine, Turkey. Electronic address: arinozturk@yahoo.com.'}, {'ForeName': 'Tayfun', 'Initials': 'T', 'LastName': 'Kirazlı', 'Affiliation': 'Department of Otolaryngology, Ege University School of Medicine, Turkey. Electronic address: tayfun.kirazli@ege.edu.tr.'}, {'ForeName': 'Ilknur', 'Initials': 'I', 'LastName': 'Veli', 'Affiliation': 'Izmir Katip Celebi University, Faculty of Dentistry, Department of Orthodontics, Turkey. Electronic address: ilknurveli@hotmail.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2022.111074']
2234,35189374,Protocol: Effectiveness of message content and format on individual and collective efficacy in reducing the intention to consume sugar-sweetened beverages.,"The strategic use of media is a common approach to promote health. A large body of evidence identifies specific features that increase message efficacy, including tailoring messages to the target audience and using a storytelling format. Yet most message testing research has focused on individual-level outcomes, ignoring the social and environmental determinants of health behaviors, which require collective action and political will to change. Grounded in an ecological approach to communication, we will carry out two double-blinded randomized experiments to test the relative effectiveness of message tailoring (culturally-tailored vs. standard) and format (narrative vs. didactic) to increase the intention to reduce individual sugar-sweetened beverage consumption, the understanding of social and commercial determinants of health, and the sense of empowerment among young adult Latinas. Based on power analyses (80% power at alpha = 0.05), we will randomize 438 participants to two groups (traditional standard infographic and culturally-tailored infographic) in the first study, and 662 participants to two groups (culturally-tailored infographic and culturally-tailored comic book) in the second study. All participants will be measured by a pre-treatment test and an immediate post-treatment test. We hypothesize that culturally-tailored comic book will be most effective, and traditional standard infographic will be least effective, on all levels of outcomes. This study will provide empirical evidence in communication strategies to help young Latinos or other racial/ethnic minority young people to pursue positive dietary behaviors that both benefit themselves and contribute to change of social norms.",2022,"We hypothesize that culturally-tailored comic book will be most effective, and traditional standard infographic will be least effective, on all levels of outcomes.","['438 participants to two groups (traditional standard infographic and culturally-tailored infographic) in the first study, and 662 participants to two groups ', 'young adult Latinas']","['message tailoring (culturally-tailored vs. standard) and format (narrative vs. didactic', 'culturally-tailored infographic and culturally-tailored comic book']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0681446', 'cui_str': 'Comic Books'}]",[],,0.0642097,"We hypothesize that culturally-tailored comic book will be most effective, and traditional standard infographic will be least effective, on all levels of outcomes.","[{'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'University of California Merced, Merced, United States. Electronic address: mzhou30@ucmerced.edu.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Chittamuru', 'Affiliation': 'University of California Merced, Merced, United States.'}, {'ForeName': 'Sandie', 'Initials': 'S', 'LastName': 'Ha', 'Affiliation': 'University of California Merced, Merced, United States.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Schillinger', 'Affiliation': 'University of California San Francisco, San Francisco, United States.'}, {'ForeName': 'A Susana', 'Initials': 'AS', 'LastName': 'Ramírez', 'Affiliation': 'University of California Merced, Merced, United States. Electronic address: sramirez37@ucmerced.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106711']
2235,34289038,"Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA.","We explored minimal residual disease (MRD) in relapsed/refractory multiple myeloma (RRMM) and transplant-ineligible (TIE) newly diagnosed multiple myeloma (NDMM) using data from 4 phase 3 studies (POLLUX, CASTOR, ALCYONE, and MAIA). Each study previously demonstrated that daratumumab-based therapies improved MRD negativity rates and reduced the risk of disease progression or death by approximately half vs standards of care. We conducted a large-scale pooled analysis for associations between patients achieving complete response or better (≥CR) with MRD-negative status and progression-free survival (PFS). MRD was assessed via next-generation sequencing (10-5 sensitivity threshold). Patient-level data were pooled from all 4 studies and for patients with TIE NDMM and patients with RRMM who received ≤2 prior lines of therapy (≤2 PL). PFS was evaluated by response and MRD status. Median follow-up (months) was 54.8 for POLLUX, 50.2 for CASTOR, 40.1 for ALCYONE, and 36.4 for MAIA. Patients who achieved ≥CR and MRD negativity had improved PFS vs those who failed to reach CR or were MRD positive (TIE NDMM and RRMM hazard ratio [HR] 0.20, P < .0001; TIE NDMM and RRMM ≤2 PL HR 0.20, P < .0001). This benefit occurred irrespective of therapy or disease setting. A time-varying Cox proportional hazard model confirmed that ≥CR with MRD negativity was associated with improved PFS. Daratumumab-based treatment was associated with more patients reaching ≥CR and MRD negativity. These findings represent the first large-scale analysis with robust methodology to support ≥CR with MRD negativity as a prognostic factor for PFS in RRMM and TIE NDMM. These trials were registered at www.clinicaltrials.gov as #NCT02076009, #NCT02136134, #NCT02195479, and #NCT02252172.",2022,"Patients who achieved ≥CR and MRD negativity had improved PFS vs those who failed to reach CR or were MRD positive (TIE NDMM and RRMM hazard ratio [HR] 0.20, P < .0001; TIE NDMM and RRMM ≤2 PL HR 0.20, P < .0001).",['relapsed/refractory multiple myeloma (RRMM) and transplant-ineligible (TIE) newly diagnosed multiple myeloma (NDMM'],[],"['MRD negativity rates', 'MRD', 'risk of disease progression or death', 'PFS', 'complete response or better (≥CR) with MRD-negative status and progression-free survival (PFS', '≥CR and MRD negativity']","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}]",[],"[{'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0883611,"Patients who achieved ≥CR and MRD negativity had improved PFS vs those who failed to reach CR or were MRD positive (TIE NDMM and RRMM hazard ratio [HR] 0.20, P < .0001; TIE NDMM and RRMM ≤2 PL HR 0.20, P < .0001).","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia ""Seràgnoli"", Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clínica Universidad de Navarra, Centro de Investigación Medica Aplicada (CIMA), IDISNA, CIBER-ONC, Pamplona, Spain.'}, {'ForeName': 'Saad Z', 'Initials': 'SZ', 'LastName': 'Usmani', 'Affiliation': 'Levine Cancer Institute/Atrium Health, Charlotte, NC.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Avet-Loiseau', 'Affiliation': 'Unite de Genomique du Myelome, IUC-Oncopole, Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Paiva', 'Affiliation': 'Clínica Universidad de Navarra, Centro de Investigación Medica Aplicada (CIMA), IDISNA, CIBER-ONC, Pamplona, Spain.'}, {'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'Arnie Charbonneau Cancer Research Institute, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Plesner', 'Affiliation': 'Vejle Hospital and University of Southern Denmark, Vejle, Denmark.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Hungria', 'Affiliation': 'Clinica Medica São Germano, São Paulo, Brazil.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Hematology, University Hospital Hôtel-Dieu, CHU Nantes, Nantes, France.'}, {'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'University Hospital of Salamanca/IBSAL/Cancer Research Center-IBMCC (USAL-CSIC), Salamanca, Spain.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Perrot', 'Affiliation': 'Hematology Department, University Cancer Institute IUCT, Toulouse, France.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Mizuho-ku Nagoya, Japan.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': 'University of Lille, CHU Lille, Service des Maladies du Sang, Lille, France.'}, {'ForeName': 'Shaji', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Hematology, Mayo Clinic Rochester, Rochester, MN.'}, {'ForeName': 'Niels W C J', 'Initials': 'NWCJ', 'LastName': 'van de Donk', 'Affiliation': 'Department of Hematology, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Krevvata', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heuck', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Medical Affairs, Horsham, PA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kobos', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Munshi', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; and.'}]",Blood,['10.1182/blood.2021011101']
2236,34857545,SGLT2 Inhibition Increases Fasting Glucagon but Does Not Restore the Counterregulatory Hormone Response to Hypoglycemia in Participants With Type 1 Diabetes.,"Individuals with type 1 diabetes have an impaired glucagon counterregulatory response to hypoglycemia. Sodium-glucose cotransporter (SGLT) inhibitors increase glucagon concentrations. We evaluated whether SGLT inhibition restores the glucagon counterregulatory hormone response to hypoglycemia. Adults with type 1 diabetes (n = 22) were treated with the SGLT2 inhibitor dapagliflozin (5 mg daily) or placebo for 4 weeks in a randomized, double-blind, crossover study. After each treatment phase, participants underwent a hyperinsulinemic-hypoglycemic clamp. Basal glucagon concentrations were 32% higher following dapagliflozin versus placebo, with a median within-participant difference of 2.75 pg/mL (95% CI 1.38-12.6). However, increased basal glucagon levels did not correlate with decreased rates of hypoglycemia and thus do not appear to be protective in avoiding hypoglycemia. During hypoglycemic clamp, SGLT2 inhibition did not change counterregulatory hormone concentrations, time to recovery from hypoglycemia, hypoglycemia symptoms, or cognitive function. Thus, despite raising basal glucagon concentrations, SGLT inhibitor treatment did not restore the impaired glucagon response to hypoglycemia. We propose that clinical reduction in hypoglycemia associated with these agents is a result of changes in diabetes care (e.g., lower insulin doses or improved glycemic variability) as opposed to a direct, physiologic effect of these medications on α-cell function.",2022,"Basal glucagon concentrations were 32% higher following dapagliflozin versus placebo, with a median within-participant difference of 2.75 pg/mL (95% CI 1.38-12.6).","['Adults with type 1 diabetes (n = 22', 'Individuals with type 1 diabetes', 'Participants With Type 1 Diabetes']","['dapagliflozin', 'placebo', 'Sodium-glucose cotransporter', 'SGLT inhibition', 'SGLT2 inhibitor dapagliflozin', 'hyperinsulinemic-hypoglycemic clamp']","['rates of hypoglycemia', 'glucagon response to hypoglycemia', 'glucagon counterregulatory response to hypoglycemia', 'glucagon concentrations', 'counterregulatory hormone concentrations, time to recovery from hypoglycemia, hypoglycemia symptoms, or cognitive function', 'basal glucagon levels', 'Counterregulatory Hormone Response to Hypoglycemia', 'Basal glucagon concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0337437', 'cui_str': 'Glucagon measurement'}]",22.0,0.187616,"Basal glucagon concentrations were 32% higher following dapagliflozin versus placebo, with a median within-participant difference of 2.75 pg/mL (95% CI 1.38-12.6).","[{'ForeName': 'Schafer C', 'Initials': 'SC', 'LastName': 'Boeder', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Gregory', 'Affiliation': 'Ian M. Burr Division of Pediatric Endocrinology and Diabetes, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Giovannetti', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Jeremy H', 'Initials': 'JH', 'LastName': 'Pettus', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of California, San Diego, La Jolla, CA.'}]",Diabetes,['10.2337/db21-0769']
2237,35197028,The effectiveness of group problem-solving therapy on women's sexual function and satisfaction after mastectomy surgery.,"BACKGROUND


Breast cancer is the second cause of death and the most common cancer in women worldwide, threatening different aspects of individual and mental health, quality of life, sexual function, and sexual satisfaction. This study aimed to determine the effectiveness of group counseling based on a problem-solving solution on women's sexual function and satisfaction after mastectomy surgery.
METHODS


The present research was an open pilot study, with a pretest, a post-test, and a follow-up period. Of women referred to the Tehran Breast Cancer Institute, 32 were selected using convenience sampling. The group received eight 90-min sessions of problem-solving solution counseling. This approach is based on cognitive-behavioral therapy and can improve an individual's ability to cope with stressful life experiences. The data collection tool was FSFI and sexual satisfaction questionnaires, which were filled before the intervention (baseline), immediately after the intervention, and one month later (follow up). Data analysis was performed using SPSS 21 statistical software application at the certainty level of 95% (P < 0.05).
RESULTS


The mean FSFI score increased from 18.37 ± 8.35 before the intervention to 20.88 ± 7.67 immediately after the intervention and 22.95 ± 5.79 one month later (P < 0.0001). Also, the mean sexual satisfaction score was 65.27 ± 5.98, 68.08 ± 5.61, and 70.46 ± 5.35 before the intervention, immediately after the intervention, and one month later, respectively (P < 0.05). The results also showed that although the two components of sexual function and satisfaction were statistically significant after sexual counseling, this improvement was not clinically progressive. The mean sexual function and satisfaction score was still low after sexual counseling.
CONCLUSIONS


It was observed that sexual function and satisfaction were improving among the patients after the intervention. Thus, sexual health counseling sessions are recommended for breast cancer patients.",2022,This approach is based on cognitive-behavioral therapy and can improve an individual's ability to cope with stressful life experiences.,"['breast cancer patients', 'Of women referred to the Tehran Breast Cancer Institute, 32 were selected using convenience sampling', ""women's sexual function and satisfaction after mastectomy surgery""]","['group problem-solving therapy', 'problem-solving solution', 'problem-solving solution counseling']","['mean FSFI score', 'mean sexual function and satisfaction score', 'sexual function and satisfaction', 'mean sexual satisfaction score']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}]",,0.0256128,This approach is based on cognitive-behavioral therapy and can improve an individual's ability to cope with stressful life experiences.,"[{'ForeName': 'Mahshid', 'Initials': 'M', 'LastName': 'Bokaie', 'Affiliation': 'Research Center for Nursing and Midwifery Care, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Ommolbanin', 'Initials': 'O', 'LastName': 'Firouzabadi', 'Affiliation': 'Shahid Sadoughi University of Medical Sciences, Yazd, Iran. O-firouzabadi@farabi.tums.ac.ir.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Joulaee', 'Affiliation': ""Special Breast Unit, Mahdieh University Women's Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}]",BMC women's health,['10.1186/s12905-022-01628-x']
2238,35197018,Designing industrial work to be 'just right' to promote health - a study protocol for a goldilocks work intervention.,"BACKGROUND


The Goldilocks Work Principle expresses that productive work should be designed to promote workers' health. We recently showed that it is feasible to develop and implement modifications to productive work that change physical behaviors (i.e. sitting, standing and being active) in a direction that may promote health among industrial workers. Therefore, the aim of the present study is to conduct a cluster randomised controlled trial investigating health effects of implementing the Goldilocks Work intervention among industrial workers.
METHODS


Our implementation plan consists of educating work teams, organizing implementation meetings, and providing feedback to workers. Three meetings with a preselected local workplace group will be scheduled. The first meeting educates the group to use a planning tool by which work can be planned to have 'just right' physical behaviors. The second and third meetings will focus on supporting implementation of the tool in daily work. An expected 28 clusters of work teams across two participating production sites will be randomized to either intervention or control group. Data collection will consist of 1) questionnaires regarding work and musculoskeletal health, 2) wearable sensor measurements of the physical behavior, and 3) assessment of general health indicators, including BMI, blood pressure, and fat percentage. The primary outcome is musculoskeletal health, measured by low back pain intensity, and secondary outcomes are 1) physical behaviors at work, 2) accumulated time in long bouts of sitting, standing, and being active and 3) perceived fatigue and energy during work. Furthermore, implementation and cost of the intervention will be evaluated based on questionnaires and data from the planning tool completed by the workers.
DISCUSSION


This study will evaluate the effectiveness and implementation of a 12 - weeks Goldilocks Work intervention with the aim of improving musculoskeletal health among industrial workers. The cluster randomized controlled study design and the evaluation of the implementation, results and costs of the intervention will make it capable of contributing with valuable evidence of how productive work may be designed to promote industrial workers' health.
TRIAL REGISTRATION


Clinical trial registration was assigned 10-09-2021 (ISRCTN80969503). https://doi.org/10.1186/ISRCTN80969503.",2022,The first meeting educates the group to use a planning tool by which work can be planned to have 'just right' physical behaviors.,['industrial workers'],[],"['musculoskeletal health, measured by low back pain intensity, and secondary outcomes are 1) physical behaviors at work, 2) accumulated time in long bouts of sitting, standing, and being active and 3) perceived fatigue and energy during work', 'general health indicators, including BMI, blood pressure, and fat percentage']","[{'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",3.0,0.0769986,The first meeting educates the group to use a planning tool by which work can be planned to have 'just right' physical behaviors.,"[{'ForeName': 'Anders Fritz', 'Initials': 'AF', 'LastName': 'Lerche', 'Affiliation': 'National Research Centre for the Working Environment, Lersø Park Allé 105, 2100, Copenhagen, Denmark. afl@nfa.dk.'}, {'ForeName': 'Svend Erik', 'Initials': 'SE', 'LastName': 'Mathiassen', 'Affiliation': 'Centre for Musculoskeletal Research, Department of Occupational Health Sciences and Psychology, University of Gävle, 80176, Gävle, Sweden.'}, {'ForeName': 'Charlotte Lund', 'Initials': 'CL', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, 7491, Trondheim, Norway.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Straker', 'Affiliation': 'School of Allied Health, Curtin University, Perth, WA, 6102, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Søgaard', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, 5230, Odense, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Holtermann', 'Affiliation': 'National Research Centre for the Working Environment, Lersø Park Allé 105, 2100, Copenhagen, Denmark.'}]",BMC public health,['10.1186/s12889-022-12643-w']
2239,35196986,"Comparison of MynxGrip vascular closure device and manual compression for closure after femoral access angiography: a randomized controlled trial: the closure devices used in every day practice study, CLOSE-UP III trial.","BACKGROUND


Complications related to femoral artery access for coronary angiography (CAG) is a safety concern. Vascular closure devices (VCDs) have been developed to reduce the rate of complications after femoral artery access. We compared the safety and efficacy of the MynxGrip VCD versus manual compression (MC) after femoral access CAG in a randomized controlled trial.
METHODS


The study was a randomized, single center, non-blinded, two-arm non-inferiority trial. The study was stopped prematurely because of low inclusion rate.
RESULTS


We randomized 869 patients to closure with the MynxGrip VCD or MC and 865 entered analyses. The incidence of the primary endpoint of major adverse vascular events (MAVE) after 30 days was 1.2% in the MynxGrip group and 0% in the MC group (p = 0.06). The median time to hemostasis was 4 [3:5] minutes and 10 [7:11] minutes in the MynxGrip group and MC group, respectively (p < 0.0001). The corresponding median times to mobilization was 73 [65:87] minutes and 76 [70:88] minutes (p = 0.01).
CONCLUSIONS


MAVE was rare after closure of femoral arterial access by both the MynxGrip VCD and MC. We found a numerical difference in favour of MC but this did not reach statistical significance. Time to hemostasis was shorter in the MynxGrip group when compared to the MC group.
TRIAL REGISTRATION


The study was approved by the local medical ethics committee and registered at clinicaltrials.org (ClinicalTrials identifier: NCT02237430 11/09/2014).",2022,"Time to hemostasis was shorter in the MynxGrip group when compared to the MC group.
","['869 patients to closure with the MynxGrip VCD or MC and 865 entered analyses', 'closure after femoral access angiography']","['Vascular closure devices (VCDs', 'coronary angiography (CAG', 'MynxGrip vascular closure device and manual compression', 'MynxGrip VCD versus manual compression (MC', 'MynxGrip']","['major adverse vascular events (MAVE', 'Time to hemostasis', 'median times to mobilization', 'safety and efficacy', 'median time to hemostasis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C3504161', 'cui_str': 'Vascular Closure Devices'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",869.0,0.527034,"Time to hemostasis was shorter in the MynxGrip group when compared to the MC group.
","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N., Denmark. larsj@dadlnet.dk.'}, {'ForeName': 'Niels R', 'Initials': 'NR', 'LastName': 'Holm', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N., Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N., Denmark.'}, {'ForeName': 'Troels', 'Initials': 'T', 'LastName': 'Thim', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N., Denmark.'}, {'ForeName': 'Steen D', 'Initials': 'SD', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N., Denmark.'}, {'ForeName': 'Lone H', 'Initials': 'LH', 'LastName': 'Mogensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N., Denmark.'}, {'ForeName': 'Evald H', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N., Denmark.'}]",BMC cardiovascular disorders,['10.1186/s12872-022-02512-0']
2240,35197356,"Evaluation of volatile sedation in the postoperative intensive care of patients recovering from heart valve surgery: protocol for a randomised, controlled, monocentre trial.","INTRODUCTION


Patients undergoing heart valve surgery are predominantly transferred postoperatively to the intensive care unit (ICU) under continuous sedation. Volatile anaesthetics are an increasingly used treatment alternative to intravenous substances in the ICU. As subject to inhalational uptake and elimination, the resulting pharmacological benefits have been repeatedly demonstrated. Therefore, volatile anaesthetics appear suitable to meet the growing demands of fast-track cardiac surgery. However, their use requires special preparation at the bedside and trained medical and nursing staff, which might limit the pharmacological benefits. The aim of our work is to assess whether the temporal advantages of recovery under volatile sedation outweigh the higher effort of special preparation.
METHODS AND ANALYSIS


The study is designed to evaluate the differences between intravenous sedatives (n=48) and volatile sedatives (n=48) in continued intensive care sedation. This study will be conducted as a prospective, randomised, controlled, single-blinded, monocentre trial at a German university hospital in consenting adult patients undergoing heart valve surgery at a university hospital. This observational study will examine the necessary preparation time, staff consultation and overall feasibility of the chosen sedation method. For this purpose, the continuation of sedation in the ICU with volatile sedatives is considered as one study arm and with intravenous sedatives as the comparison group. Due to rapid elimination and quick awakening after the termination of sedation, closer consultation between the attending physician and the ICU nursing staff is required, in addition to a prolonged setup time. Study analysis will include the required setup time, time from admission to extubation as primary outcome and neurocognitive assessability. In addition, possible operation-specific (blood loss, complications), treatment parameters (catecholamine dosages, lung function) and laboratory results (acute kidney injury, acid base balance (lactataemia), liver failure) as influencing factors will be collected. The study-relevant data will be extracted from the continuous digital records of the patient data management system after the patient has been discharged from the ICU. For statistical evaluation, 95% CIs will be calculated for the median time to extubation and neurocognitive assessability, and the association will be assessed with a Cox regression model. In addition, secondary binary outcome measures will be evaluated using Fisher's exact tests. Further descriptive and exploratory statistical analyses are also planned.
ETHICS AND DISSEMINATION


The study was approved by the Institutional Ethics Board of the University of Frankfurt, Germany (#20-1050). Informed consent of all individual patients will be obtained before randomisation. Results will be disseminated via publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


Clinical trials registration (NCT04958668) was completed on 1 July 2021.",2022,"For statistical evaluation, 95% CIs will be calculated for the median time to extubation and neurocognitive assessability, and the association will be assessed with a Cox regression model.","['patients recovering from heart valve surgery', 'German university hospital in consenting adult patients undergoing heart valve surgery at a university hospital', 'Patients undergoing heart valve surgery are predominantly transferred postoperatively to the intensive care unit (ICU) under continuous sedation', 'n=48) in continued intensive care sedation']","['intravenous sedatives', 'volatile sedation', 'volatile sedatives']","['possible operation-specific (blood loss, complications), treatment parameters (catecholamine dosages, lung function) and laboratory results (acute kidney injury, acid base balance (lactataemia), liver failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0001117', 'cui_str': 'Acid-base equilibrium'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}]",,0.0789112,"For statistical evaluation, 95% CIs will be calculated for the median time to extubation and neurocognitive assessability, and the association will be assessed with a Cox regression model.","[{'ForeName': 'Armin Niklas', 'Initials': 'AN', 'LastName': 'Flinspach', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Germany, Klinikum der Johann Wolfgang Goethe-Universität Frankfurt, Frankfurt am Main, Hessen, Germany armin.flinspach@kgu.de.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Herrmann', 'Affiliation': 'Department of Biostatistic and Mathematic Modeling, Goethe University, Frankfurt, Germany, Goethe-Universitat Frankfurt am Main, Frankfurt am Main, Hessen, Germany.'}, {'ForeName': 'Florian Jürgen', 'Initials': 'FJ', 'LastName': 'Raimann', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Germany, Klinikum der Johann Wolfgang Goethe-Universität Frankfurt, Frankfurt am Main, Hessen, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zacharowski', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Germany, Klinikum der Johann Wolfgang Goethe-Universität Frankfurt, Frankfurt am Main, Hessen, Germany.'}, {'ForeName': 'Elisabeth Hannah', 'Initials': 'EH', 'LastName': 'Adam', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Germany, Klinikum der Johann Wolfgang Goethe-Universität Frankfurt, Frankfurt am Main, Hessen, Germany.'}]",BMJ open,['10.1136/bmjopen-2021-057804']
2241,35200288,"Effects of Transcranial Direct Current Stimulation on Brain Electrical Activity, Heart Rate Variability, and Dual-Task Performance in Healthy and Fibromyalgia Women: A Study Protocol.","People with fibromyalgia could experience physical and cognitive impairments. Furthermore, when performing two tasks at the same time, people with fibromyalgia showed a higher dual-task cost compared to a single task than healthy people. This may result in poorer performance of activities of daily living that are commonly presented as a combination of two or more tasks. Transcranial direct current stimulation (tDCS) is a promising nonpharmacological therapy. However, there is controversy regarding the intensities and the effectiveness of this therapy. Thus, the present study will aim: (1) to compare the effectiveness and the impact of two tDCS intensities (1 mA and 2 mA) on cognitive, motor, brain functions, and cardiac autonomic modulation; (2) to study the impact of tDCS on the dual-task performance and creativity after applying tDCS in dorsolateral prefrontal cortex. In this study, 26 women will participate and will be divided into two groups: women with fibromyalgia ( n  = 13), and healthy controls ( n  = 13). A reduction in cognitive-motor interference in dual-task performance is expected, as well as a modification in neurophysiological parameters and an improvement in cardiac autonomic modulation. Lastly, no different effects are expected depending on the stimulation intensity applied. The obtained results will help to determine if tDCS in the dorsolateral prefrontal cortex could improve the occupational performance of women with fibromyalgia.",2022,"Furthermore, when performing two tasks at the same time, people with fibromyalgia showed a higher dual-task cost compared to a single task than healthy people.","['Healthy and Fibromyalgia Women', 'People with fibromyalgia could experience physical and cognitive impairments', '26 women will participate and will be divided into two groups: women with fibromyalgia ( n  = 13), and healthy controls ( n  = 13', 'dorsolateral prefrontal cortex', 'women with fibromyalgia']","['Transcranial Direct Current Stimulation', 'tDCS', 'Transcranial direct current stimulation (tDCS']","['Brain Electrical Activity, Heart Rate Variability, and Dual-Task Performance', 'occupational performance', 'dual-task cost', 'cognitive, motor, brain functions, and cardiac autonomic modulation']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",26.0,0.015436,"Furthermore, when performing two tasks at the same time, people with fibromyalgia showed a higher dual-task cost compared to a single task than healthy people.","[{'ForeName': 'Mari Carmen', 'Initials': 'MC', 'LastName': 'Gomez-Alvaro', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Villafaina', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Juan Luis', 'Initials': 'JL', 'LastName': 'Leon-Llamas', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Murillo-Garcia', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Melo-Alonso', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Sánchez-Gómez', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Molero', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Cano-Plasencia', 'Affiliation': 'Clinical Neurophysiology, San Pedro de Alcántara Hospital, 10003 Cáceres, Spain.'}, {'ForeName': 'Narcis', 'Initials': 'N', 'LastName': 'Gusi', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}]","Behavioral sciences (Basel, Switzerland)",['10.3390/bs12020037']
2242,35200284,Effects of Mind-Body Interventions on Adolescents' Cooperativeness and Emotional Symptoms.,"BACKGROUND


Mind-body interventions may support the development of adolescents' self-regulation and provide a protective effect against maladaptive outcomes, e.g., internalizing and externalizing problems. The present study aimed at evaluating the effects of mindfulness-oriented meditation training (MOM) and autogenic training (AT) on a group of healthy Italian adolescents' character dimensions, emotional and behavioral difficulties.
METHODS


72 adolescents were randomly assigned to MOM/AT conditions and tested before and after the 8-week trainings through self-report measures (Temperament and Character Inventory 125, TCI; Strengths and Difficulties Questionnaire for Adolescents, SDQ-A). Main analyses involved robust and repeated measures ANOVAs, carried out separately for character TCI and SDQ-A scales.
RESULTS


After trainings, we found increased levels of cooperativeness and reduced emotional symptoms. Changes in these dimensions were negatively correlated: the more participants increased in their cooperativeness the greater decrease they showed in emotional symptoms.
CONCLUSION


Both MOM and AT enhanced a cooperative attitude in adolescents and helped reducing their emotional problems. Therefore, it may be useful to apply these mind-body interventions in school settings as they can have a protective effect on the well-being and psychosocial adjustment of youths, through fostering their character maturity and helping them to better regulate their emotions.",2022,"Changes in these dimensions were negatively correlated: the more participants increased in their cooperativeness the greater decrease they showed in emotional symptoms.
","[""Adolescents' Cooperativeness and Emotional Symptoms"", '72 adolescents', ""healthy Italian adolescents' character dimensions, emotional and behavioral difficulties""]","['mindfulness-oriented meditation training (MOM) and autogenic training (AT', 'Mind-Body Interventions']","['emotional symptoms', 'character TCI and SDQ-A scales', 'levels of cooperativeness and reduced emotional symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009964', 'cui_str': 'Cooperative Behavior'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004361', 'cui_str': 'Autogenic therapy'}, {'cui': 'C1513305', 'cui_str': 'Mind-Body Medicine'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009964', 'cui_str': 'Cooperative Behavior'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",72.0,0.0704539,"Changes in these dimensions were negatively correlated: the more participants increased in their cooperativeness the greater decrease they showed in emotional symptoms.
","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Feruglio', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, 33100 Udine, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Pascut', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, 33100 Udine, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Matiz', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, 33100 Udine, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Paschetto', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, 33100 Udine, Italy.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Crescentini', 'Affiliation': 'Department of Languages and Literatures, Communication, Education and Society, University of Udine, 33100 Udine, Italy.'}]","Behavioral sciences (Basel, Switzerland)",['10.3390/bs12020033']
2243,35200280,"Investigating the Role of Insight, Decision-Making and Mentalizing in Functional Outcome in Schizophrenia: A Cross-Sectional Study.","BACKGROUND


Recovery has become a priority in schizophrenia spectrum disorders (SSDs). This study aimed to investigate predictors of objective-general functioning and disability-and subjective-quality of life (QoL)-measures of functional outcomes in SSD.
METHODS


Sample:  n  = 77 SSD outpatients (age 18-64, IQ > 70) participating in a randomised controlled trial. Baseline data were used to build three multivariable linear regression models on: (i) general functioning-General Assessment of Functioning (GAF); (ii) disability-the World Health Organization Disability Assessment Schedule (WHODAS-2.0); and (iii) QoL-Satisfaction Life Domains Scale (SLDS).
RESULTS


Young age and being employed (R 2  change = 0.211;  p  = 0.001), late adolescence premorbid adjustment (R 2  change = 0.049;  p  = 0.0050), negative symptoms and disorganization (R 2  change = 0.087;  p  = 0.025) and Theory of Mind (R 2  change = 0.066,  p  = 0.053) predicted general functioning. Previous suicidal behaviour (R 2  change = 0.068;  p  = 0.023) and negative and depressive symptoms (R 2  change = 0.167;  p  = 0.001) were linked with disability. Previous suicidal behaviour (R 2  change = 0.070,  p  = 0.026), depressive symptoms (R 2  change = 0.157;  p  < 0.001) and illness recognition (R 2  change = 0.046,  p  = 0.044) predicted QoL.
CONCLUSIONS


Negative, disorganization and depressive symptoms, older age, unemployment, poor premorbid adjustment, previous suicide attempts and illness awareness appear to underlie a poor global functional outcome in SSD. Achieving recovery in SSD appears to require both symptomatic remission (e.g., through antipsychotics) and measures to improve mastery and relieve low mood.",2022,"Previous suicidal behaviour (R 2  change = 0.070,  p  = 0.026), depressive symptoms (R 2  change = 0.157;  p  < 0.001) and illness recognition (R 2  change = 0.046,  p  = 0.044) predicted QoL.
CONCLUSIONS


Negative, disorganization and depressive symptoms, older age, unemployment, poor premorbid adjustment, previous suicide attempts and illness awareness appear to underlie a poor global functional outcome in SSD.","['Schizophrenia', 'Sample:  n  = 77 SSD outpatients (age 18-64, IQ > 70) participating in a randomised controlled trial']",[],"['general functioning', 'late adolescence premorbid adjustment', 'objective-general functioning and disability-and subjective-quality of life (QoL)-measures of functional outcomes', 'negative symptoms and disorganization', 'Previous suicidal behaviour', 'illness recognition', 'negative and depressive symptoms', 'general functioning-General Assessment of Functioning (GAF); (ii) disability-the World Health Organization Disability Assessment Schedule (WHODAS-2.0); and (iii) QoL-Satisfaction Life Domains Scale (SLDS', 'depressive symptoms']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0723179', 'cui_str': 'SSD'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0588388', 'cui_str': 'General observation'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0451124', 'cui_str': 'Disability assessment schedule'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",77.0,0.101944,"Previous suicidal behaviour (R 2  change = 0.070,  p  = 0.026), depressive symptoms (R 2  change = 0.157;  p  < 0.001) and illness recognition (R 2  change = 0.046,  p  = 0.044) predicted QoL.
CONCLUSIONS


Negative, disorganization and depressive symptoms, older age, unemployment, poor premorbid adjustment, previous suicide attempts and illness awareness appear to underlie a poor global functional outcome in SSD.","[{'ForeName': 'Paula Jhoana', 'Initials': 'PJ', 'LastName': 'Escobedo-Aedo', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, 28040 Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Forjan-González', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, 28040 Madrid, Spain.'}, {'ForeName': 'Adela', 'Initials': 'A', 'LastName': 'Sánchez-Escribano Martínez', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, 28040 Madrid, Spain.'}, {'ForeName': 'Verónica González', 'Initials': 'VG', 'LastName': 'Ruiz-Ruano', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, 28040 Madrid, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Sánchez-Alonso', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, 28040 Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mata-Iturralde', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, 28040 Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Muñoz-Lorenzo', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, 28040 Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Baca-García', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, 28040 Madrid, Spain.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'David', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, Institute of Mental Health, University College London, London WC1E 6BT, UK.'}, {'ForeName': 'Javier-David', 'Initials': 'JD', 'LastName': 'Lopez-Morinigo', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, 28040 Madrid, Spain.'}]","Behavioral sciences (Basel, Switzerland)",['10.3390/bs12020028']
2244,35200261,Effects of the Presence of Pseudoexfoliation on Intraocular Pressure and Retinal Nerve Fiber Layer Thickness in Patients with Macular Degeneration Receiving Intravitreal Ranibizumab.,"AIMS


In the present study, we aimed to compare the effect of intravitreal ranibizumab (IVR) treatment on intraocular pressure (IOP) and retinal nerve fiber layer (RNFL) thickness in patients with age-related macular degeneration (AMD) with and without pseudoexfoliation (PEX).
MATERIALS AND METHODS


A total of 24 patients, 12 with PEX (12 eyes) and 12 without PEX (12 eyes), receiving IVR treatment for neovascular AMD between June 2017 and June 2019, were included in the study. Exclusion criteria were composed of the history of glaucoma, uveitis, intravitreal steroid administration, pars plana vitrectomy surgery, and less than three IVR injections. Such criteria as age, gender, follow-up times, number of injections administered, IOP, and RNFL thickness before the first injection and one month after the last injection were also recorded.
RESULTS


Age, gender, follow-up time, and the number of injections were similar in groups with and without PEX ( p  > 0.05). While mean post-treatment IOP values were not significantly higher in the PEX group (14.50 ± 3.06 vs. 12.91 ± 1.83 mmHg,  p  = 0.065), the values were significant for the non-PEX group (13.25 ± 2.76 vs. 11.83 ± 2.69 mmHg,  p  = 0.01), and these values were within normal IOP limits. Additionally, RNFL thickness was significantly thinner after treatment in both groups (91.41 ± 7.14 vs. 94.00 ± 6.76 in those with PEX; 95.58 ± 5.91 vs. 97.66 ± 6.89 in those without PEX;  p  < 0.05). The decrease in RNFL thickness in the PEX group was 2.58 ± 1.62 µ and in the non-PEX group was 2.08 ± 1.98 µ. However, there was no statistically significant difference between the two groups in terms of RNFL thinning ( p  = 0.505).
DISCUSSION


Ranibizumab may reduce RNFL thickness in patients with PEX. Longer-term studies including larger populations are necessary for understanding IOP and RNFL changes after anti-vascular endothelial growth factor (anti-VEGF) injection.",2022,"time, and the number of injections were similar in groups with and without PEX ( p  > 0.05).","['patients with PEX', '24 patients, 12 with PEX (12 eyes) and 12 without PEX (12 eyes), receiving IVR treatment for neovascular AMD between June 2017 and June 2019, were included in the study', 'Patients with Macular Degeneration Receiving Intravitreal Ranibizumab', 'patients with age-related macular degeneration (AMD) with and without pseudoexfoliation (PEX']","['Ranibizumab', 'Pseudoexfoliation', 'PEX', 'intravitreal ranibizumab (IVR']","['RNFL thickness', 'number of injections', 'intraocular pressure (IOP) and retinal nerve fiber layer (RNFL) thickness', 'RNFL thinning', 'Intraocular Pressure and Retinal Nerve Fiber Layer Thickness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024437', 'cui_str': 'Degenerative disorder of macula'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",24.0,0.0312785,"time, and the number of injections were similar in groups with and without PEX ( p  > 0.05).","[{'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Daldal', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Usak University, Usak 64000, Turkey.'}, {'ForeName': 'Melike Balikoglu', 'Initials': 'MB', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, İzmir Katip Celebi University, İzmir 35620, Turkey.'}]",Clinics and practice,['10.3390/clinpract12010009']
2245,34865318,A novel drug delivery system using acyclovir nanofiber patch for topical treatment of recurrent herpes labialis: A randomized clinical trial.,"OBJECTIVES


Topical treatment with acyclovir cream has shown low efficacy in recent studies. Nano drug delivery systems, have received much attention in recent decades. The aim of this study was to compare the efficacy of acyclovir nanofiber patch with acyclovir cream.
MATERIAL AND METHODS


In this double-blind three-armed randomized clinical trial, a total of 60 patients with recurrent labial herpes, were randomly divided into three groups, each consisting of 20. The patients in the first, second, and third groups were treated with acyclovir nanofiber patch, placebo nanofiber patch, and acyclovir cream, respectively. A numerical scale was used by the patients to record the self-reported symptoms. Symptoms score, crusting time and healing time were assessed by the clinician. Kruskal-Wallis test was used to compare the symptoms between the three groups, a survival test was also performed to evaluate the crusting and healing time. Data were analyzed in SPSS V22 at P-value < 0.05.
RESULTS


The mean scores of symptoms at baseline were 1.6, 1.5, and 1.4 in the first, second, and third groups, respectively. The symptoms were not significantly different between the three groups on different treatment days. The mean crusting time was 2.3, 2.4, and 2.6 days in the three groups, and the mean healing time was 7.4, 7.2, and 7.7 days, respectively. Crusting time and healing time were not significantly different between the three groups.
CONCLUSIONS


Acyclovir nanofiber patches are recommended for accelerating symptom relief in recurrent labial herpes, however, they are not effective in shortening the crusting or healing time.
CLINICAL TRIAL REGISTRATION NUMBER


IRCT20141124020073N2. Registered in: Iranian Registry of Clinical Trials (www.irct.ir).",2022,"Crusting time and healing time were not significantly different between the three groups.
","['recurrent herpes labialis', '60 patients with recurrent labial herpes']","['acyclovir nanofiber patch, placebo nanofiber patch, and acyclovir cream', 'acyclovir cream', 'acyclovir nanofiber patch', 'acyclovir nanofiber patch with acyclovir cream']","['Crusting time and healing time', 'mean healing time', 'mean crusting time', 'mean scores of symptoms', 'crusting and healing time', 'Symptoms score, crusting time and healing time']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}]","[{'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C1881960', 'cui_str': 'Nanofibers'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1251800', 'cui_str': 'Acyclovir Topical Cream'}]","[{'cui': 'C0205204', 'cui_str': 'Crust'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",60.0,0.0500556,"Crusting time and healing time were not significantly different between the three groups.
","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Golestannejad', 'Affiliation': 'Department of Oral Medicine, Dental Research Center, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Faezeh', 'Initials': 'F', 'LastName': 'Khozeimeh', 'Affiliation': 'Department of Oral Medicine, Dental Research Center, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mehrasa', 'Affiliation': 'Department of Biotechnology, School of Advanced Sciences and Technologies, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Mirzaeei', 'Affiliation': 'Pharmaceutical Sciences Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Dorna', 'Initials': 'D', 'LastName': 'Sarfaraz', 'Affiliation': 'Dental Students Research Committee, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Clinical and experimental dental research,['10.1002/cre2.512']
2246,35202073,Protocol for the Optimizing Naloxone Dispensing in Pharmacies (ONDP) Online Continuing Education Program: A Randomized Controlled Trial.,"The number of opioid-related deaths in Canada has steadily increased since 2016 and the COVID-19 pandemic has worsened this trend. Naloxone has been pivotal for reducing opioid-related harms and death, and pharmacists play a crucial role in ensuring the supply of naloxone to Canadians through community pharmacies. However, naloxone dispensing by pharmacists is not optimal; in fact, in Ontario, only 50% of pharmacists offer naloxone, despite national guidelines that pharmacists should offer naloxone to everyone with an opioid prescription. When asked why pharmacists do not proactively offer naloxone, recent research has identified that pharmacists need continuing education to boost confidence and knowledge on how to start conversations with patients. The study involves a delayed start, double-blind randomized controlled trial, for Canadian licensed pharmacists and pharmacy technicians. The goals of the program are to increase Canadian pharmacy professional's knowledge, confidence, and motivation to proactively offer naloxone, as well as to decrease stigma associated with naloxone. The program incorporates behaviour change techniques from the Theoretical Domains Framework and the Theory of Planned Behaviour. The intervention program includes three modules that focus on improving pharmacists' communication skills by teaching them how to proactively offer naloxone, while the control group will complete a reading assignment on the naloxone consensus guidelines. The program will involve a process and outcome evaluation in addition to a contribution analysis. This program is important for breaking down previously identified barriers and knowledge gaps for why pharmacists currently do not proactively offer naloxone. This study will provide important new information about what behaviour change techniques are successful in improving confidence and motivation in the pharmacy profession and in an online environment. Findings from this study can be used to produce a national naloxone education program that can also be implemented into current pharmacy school curriculum.",2022,The number of opioid-related deaths in Canada has steadily increased since 2016 and the COVID-19 pandemic has worsened this trend.,"['Pharmacies (ONDP', 'Canadian licensed pharmacists and pharmacy technicians']","['Naloxone', 'naloxone', 'Online Continuing Education Program']",[],"[{'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0260119', 'cui_str': 'Pharmacy technician'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0013626', 'cui_str': 'Continuing Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.112591,The number of opioid-related deaths in Canada has steadily increased since 2016 and the COVID-19 pandemic has worsened this trend.,"[{'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Cid', 'Affiliation': 'School of Pharmacy, University of Waterloo, 10 Victoria St. S A, Kitchener, ON N2G 1C5, Canada.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'School of Pharmacy, University of Waterloo, 10 Victoria St. S A, Kitchener, ON N2G 1C5, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Beazely', 'Affiliation': 'School of Pharmacy, University of Waterloo, 10 Victoria St. S A, Kitchener, ON N2G 1C5, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Grindrod', 'Affiliation': 'School of Pharmacy, University of Waterloo, 10 Victoria St. S A, Kitchener, ON N2G 1C5, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Yessis', 'Affiliation': 'School of Public Health Sciences, University of Waterloo, 200 University Ave. W, Waterloo, ON N2L 3G1, Canada.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chang', 'Affiliation': 'School of Pharmacy, University of Waterloo, 10 Victoria St. S A, Kitchener, ON N2G 1C5, Canada.'}]","Pharmacy (Basel, Switzerland)",['10.3390/pharmacy10010024']
2247,35202553,A Randomized Controlled Trial Exploring Safety and Tolerability of Sulthiame in Sleep Apnea.,"RATIONAL


Current therapies in obstructive sleep apnea (OSA) are limited by insufficient efficacy, compliance or tolerability. An effective pharmacological treatment in OSA is warranted. Carbonic anhydrase (CA) inhibition has been shown to ameliorate OSA.
OBJECTIVE


To explore safety and tolerability of the CA inhibitor sulthiame (STM) in OSA.
METHODS


A four week double-blind, randomized, placebo-controlled dose guiding trial in patients with moderate/severe OSA not tolerating positive airway pressure treatment.
MEASUREMENTS AND RESULTS


Intermittent paresthesia was reported by 79, 67 and 18% of patients receiving 400 mg STM (N=34), 200 mg STM (N=12) or placebo (N=22), respectively. Dyspnea was reported only after 400 mg STM (18%). Six patients in the higher dose group withdrew due to an adverse event. There were no serious adverse events. STM reduced the apnea-hypopnea index (AHI) from 55.3 to 33.1 events/h ( 41.0%) in the 400 mg group and from 61.2 to 40.7 events/h ( 32.1%) after 200 mg (p<0.001, respectively). Corresponding placebo values were 53.9 and 50.9 events/h ( 5.4 %). The AHI reduction threshold of ≥50% was reached in 40% after 400 mg, 25% after 200 mg and 5% following placebo. Mean overnight oxygen saturation improved by 1.1% after 400 mg and 200 mg (p<0.001 and p=0.034, respectively). Patient related outcomes were unchanged.
CONCLUSIONS


STM showed a satisfactory safety profile in moderate/severe OSA. STM reduced OSA by more than 20 events/h, one of the strongest reductions reported in a drug trial in OSA. Larger scale clinical studies of STM in OSA are justified. Clinical trial registration available at https://www.clinicaltrialsregister.eu/https://www.clinicaltrialsregister.eu/, ID: 2017-004767-13 This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).",2022,"Mean overnight oxygen saturation improved by 1.1% after 400 mg and 200 mg (p<0.001 and p=0.034, respectively).","['Sleep Apnea', 'obstructive sleep apnea (OSA', 'patients with moderate/severe OSA not tolerating positive airway pressure treatment']","['Carbonic anhydrase (CA) inhibition', 'CA inhibitor sulthiame (STM', 'STM', 'placebo', 'OSA']","['serious adverse events', 'Dyspnea', 'apnea-hypopnea index (AHI', 'STM reduced OSA', 'AHI reduction threshold', 'Mean overnight oxygen saturation']","[{'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0007028', 'cui_str': 'Carbonate dehydratase'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0007036', 'cui_str': 'Carbonic anhydrase inhibitor'}, {'cui': 'C0038807', 'cui_str': 'sulthiame'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0038807', 'cui_str': 'sulthiame'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",,0.299024,"Mean overnight oxygen saturation improved by 1.1% after 400 mg and 200 mg (p<0.001 and p=0.034, respectively).","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hedner', 'Affiliation': 'University of Gothenburg Sahlgrenska Academy, 70712, Internal Medicine, Center for Sleep and Wake Disorders, Goteborg, Sweden; jan.hedner@lungall.gu.se.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Stenlöf', 'Affiliation': 'University of Gothenburg Sahlgrenska Academy, 70712, Internal Medicine, Center for Sleep and Wake Disorders, Goteborg, Sweden.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Zou', 'Affiliation': 'University of Gothenburg Sahlgrenska Academy, 70712, Internal Medicine, Center for Sleep and Wake Disorders, Goteborg, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hoff', 'Affiliation': 'University of Gothenburg Sahlgrenska Academy, 70712, Internal Medicine, Center for Sleep and Wake Disorders, Goteborg, Sweden.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Hansen', 'Affiliation': 'Desitin Arzneimittel GmbH, 60840, Hamburg, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Kuhn', 'Affiliation': 'Desitin Arzneimittel GmbH, 60840, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lennartz', 'Affiliation': 'Desitin Arzneimittel GmbH, 60840, Hamburg, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Grote', 'Affiliation': 'University of Gothenburg Sahlgrenska Academy, 70712, Internal Medicine, Center for Sleep and Wake Disorders, Goteborg, Sweden.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202109-2043OC']
2248,35203045,"Vitamin K2 as a potential therapeutic candidate for the prevention of muscle cramps in hemodialysis patients: A prospective multicenter, randomized, controlled, crossover pilot trial.","OBJECTIVES


Muscle cramps occur in 33% to 78% of patients with dialysis. The etiology of muscle cramps is poorly understood, and no clear evidence-based prevention or treatment strategies exist. Improved interventions are urgently needed. The aim of this study was to investigate the effect of vitamin K2 in reducing the frequency and severity of muscle cramps in hemodialysis (HD) patients.
METHODS


This multicenter, randomized, placebo-controlled, crossover clinical trial was conducted from June 2019 to May 2020. Each participant received vitamin K2 (360 µg/d) or placebo for two 4-wk phases, and then crossed to the alternative arm for two 4-wk phases after a 2-wk washout. The primary endpoint was the frequency of muscle cramps during HD. The secondary endpoints were severity and duration of muscle cramps during HD.
RESULTS


A total of 523 patients with maintenance HD were screened for muscle cramps, including 41 patients with muscle cramps refractory to conventional interventions, were enrolled. Nineteen patients in the vitamin K2-initial group and 20 in the placebo-initial group completed the protocol, and were included in the final analysis. Vitamin K2 reduced the frequency, duration, and severity of muscle cramps in HD patients (all P < 0.05). The frequency, duration, and severity of muscle cramps in HD patients increased again after crossing over to the placebo. There were no serious adverse events. One patient experienced gastrointestinal discomfort when taking vitamin K2.
CONCLUSIONS


This pilot trial demonstrated that vitamin K2 supplementation could decrease the frequency, duration, and severity of muscle cramps in HD patients.",2022,"The frequency, duration, and severity of muscle cramps in HD patients increased again after crossing over to the placebo.","['hemodialysis (HD) patients', 'hemodialysis patients', 'Nineteen patients in the vitamin K2-initial group and 20 in the', '523 patients with maintenance HD were screened for muscle cramps, including 41 patients with muscle cramps refractory to conventional interventions, were enrolled', 'June 2019 to May 2020', 'HD patients']","['placebo', 'vitamin K2 supplementation', 'vitamin K2', 'Vitamin K2']","['frequency, duration, and severity of muscle cramps', 'serious adverse events', 'severity and duration of muscle cramps during HD', 'frequency of muscle cramps during HD', 'gastrointestinal discomfort']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}]",523.0,0.163419,"The frequency, duration, and severity of muscle cramps in HD patients increased again after crossing over to the placebo.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Department of Nephrology, Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College, Chengdu, Sichuan, China; School of Clinical Medicine, North Sichuan Medical College, Nanchong, Sichuan, China.'}, {'ForeName': 'AnXiu', 'Initials': 'A', 'LastName': 'Yang', 'Affiliation': 'School of Clinical Medicine, North Sichuan Medical College, Nanchong, Sichuan, China.'}, {'ForeName': 'Ruijun', 'Initials': 'R', 'LastName': 'Ren', 'Affiliation': 'School of Clinical Medicine, North Sichuan Medical College, Nanchong, Sichuan, China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Shan', 'Affiliation': 'Department of Nephrology, Changsha Jieao Hospital, Changsha, Hunan, China.'}, {'ForeName': 'Yuan Ming', 'Initials': 'YM', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Changsha Jieao Hospital, Changsha, Hunan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': ""School of Clinical Medicine, North Sichuan Medical College, Nanchong, Sichuan, China; Department of Hematology, Chengdu Third People's Hospital, Chengdu, Sichuan, China. Electronic address: 79468064@qq.com.""}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2022.111608']
2249,35187867,Effects of resistance training intensity on muscle quantity/quality in middle-aged and older people: a randomized controlled trial.,"BACKGROUND


A sarcopenia diagnosis is confirmed by the presence of low muscle quantity or quality under the 2018 revised definition by the European Working Group on Sarcopenia in Older People 2. Imaging methods [i.e. magnetic resonance imaging (MRI)], dual-energy X-ray absorptiometry (DXA), and bioelectrical impedance analysis are tools to evaluate muscle quantity or quality. The present study aimed to investigate whether and how low-intensity and moderate-intensity resistance training improved both muscle quantity and quality measured by MRI, DXA, and segmental bioelectrical impedance spectroscopy (S-BIS) in middle-aged and older people.
METHODS


A single-blind, randomized, controlled trial was conducted. Community-dwelling people aged 50-79 years were randomly allocated to no exercise (no-Ex), low-intensity exercise (low-Ex), and moderate-intensity exercise (moderate-Ex) groups. Participants in the exercise groups performed resistance training for 24 weeks, with loads of 40% and 60% of one repetition maximum in the low-Ex and moderate-Ex groups, respectively. Cross-sectional area (CSA), lean mass, and muscle electrical properties on S-BIS were used to determine the effects of training interventions on muscle quantity and quality of the lower limbs.
RESULTS


Fifty participants (no-Ex 17, age 63.5 ± 8.5 years, women 47.1%; low-Ex 16, age 63.6 ± 8.1 years, women 50.0%; moderate-Ex 17, age 63.5 ± 8.3 years, women 52.9%) completed the 24 week exercise intervention. For the primary outcome, significant intervention effects were found in thigh muscle CSA on MRI between the moderate-Ex and no-Ex groups (+6.8 cm 2  , P < 0.01). Low-Ex for 24 weeks only increased quadriceps CSA (+2.3 cm 2  , P < 0.05). The per cent change of thigh muscle CSA (+7.0%, P < 0.01) after 24 week moderate-Ex was higher than that of leg lean mass on DXA (+2.3%, P = 0.088). Moderate-Ex for 24 weeks also improved S-BIS electrical properties related to muscle quantity and quality, including the intracellular resistance index (+0.1 cm 2  /Ω, P < 0.05), membrane capacitance (+0.7 nF, P < 0.05), and phase angle (+0.3 deg, P < 0.05); their changes were positively correlated with that of thigh muscle CSA (P < 0.01).
CONCLUSIONS


Resistance exercise with moderate intensity improved muscle quantity and quality measured by MRI and S-BIS, whereas that with low intensity only increased muscle quantity in middle-aged and older people. The comparisons among the responses to exercise between the assessment methods indicate the greater value of MRI and S-BIS to measure changes of muscle quantity and quality than of lean mass measured by DXA for assessing the local effects of resistance training.",2022,"Low-Ex for 24 weeks only increased quadriceps CSA (+2.3 cm 2  , P < 0.05).","['Fifty participants (no-Ex 17, age 63.5\xa0±\xa08.5\xa0years, women 47.1%; low-Ex 16, age 63.6\xa0±', 'Community-dwelling people aged 50-79\xa0years', '8.1\xa0years, women 50.0%; moderate-Ex 17, age 63.5\xa0±\xa08.3\xa0years, women 52.9%) completed the 24\xa0week exercise intervention', 'middle-aged and older people']","['Imaging methods [i.e. magnetic resonance imaging (MRI)], dual-energy X-ray absorptiometry (DXA', 'resistance training', 'no exercise (no-Ex), low-intensity exercise (low-Ex), and moderate-intensity exercise (moderate-Ex', 'low-intensity and moderate-intensity resistance training', 'resistance training intensity']","['muscle quantity', 'thigh muscle CSA on MRI', 'muscle quantity and quality measured by MRI, DXA, and segmental bioelectrical impedance spectroscopy (S-BIS', 'muscle quantity/quality', 'muscle quantity and quality measured by MRI and S-BIS', 'membrane capacitance', 'thigh muscle CSA', 'quadriceps CSA', 'muscle quantity and quality of the lower limbs', 'muscle quantity and quality, including the intracellular resistance index']","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C1275506', 'cui_str': 'Imaging - action'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0224416', 'cui_str': 'Skeletal muscle structure of thigh'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242264', 'cui_str': 'Capacitance, Electrical'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0374055,"Low-Ex for 24 weeks only increased quadriceps CSA (+2.3 cm 2  , P < 0.05).","[{'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Otsuka', 'Affiliation': 'Institute for Health Care Science, Suntory Wellness Ltd., Kyoto, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition Tokyo, Tokyo, Japan.'}, {'ForeName': 'Akifumi', 'Initials': 'A', 'LastName': 'Maeda', 'Affiliation': 'Suntory Global Innovation Center Ltd., Research Institute, Kyoto, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Izumo', 'Affiliation': 'Institute for Health Care Science, Suntory Wellness Ltd., Kyoto, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Rogi', 'Affiliation': 'Institute for Health Care Science, Suntory Wellness Ltd., Kyoto, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Shibata', 'Affiliation': 'Institute for Health Care Science, Suntory Wellness Ltd., Kyoto, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Fukuda', 'Affiliation': 'Fukuda Clinic, Osaka, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Arimitsu', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kyoto, Japan.'}, {'ForeName': 'Naokazu', 'Initials': 'N', 'LastName': 'Miyamoto', 'Affiliation': 'Graduate School of Health and Sports Science, Juntendo University, Chiba, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Hashimoto', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kyoto, Japan.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12941']
2250,35189580,Managing neuropsychological impairment in multiple sclerosis - Controlled study on a standardized metacognitive intervention (MaTiMS).,"OBJECTIVE


Multiple sclerosis (MS) is an inflammatory and neurodegenerative disease of the central nervous system of potential autoimmune origin that is frequently associated with neuropsychiatric symptoms and cognitive deficits, as well as with fatigue, stress and psychosocial burden. In the present controlled multi-centre trial we investigated whether two specific neuropsychological interventions (1. metacognitive training (MaTiMS); 2. computerized working memory training (BrainStim) in combination with MaTiMS) applied as add-on therapies to real life standard rehabilitation lead to increased benefit in self-perceived cognitive deficits (the primary outcome) in MS patients compared to standard rehab.
METHODS


288 adult persons in three German rehab centers with a confirmed diagnosis of MS were sequentially allocated to one of the three intervention groups. 249 (87%) participants completed the post assessment and 187 (63%) the online survey after 12 months. Perceived cognitive deficits, mood, fatigue, coping, and activity were evaluated by self-reports and neuropsychological tests at baseline and 4 weeks postintervention. All self-reports were additionally administered digitally at three, six, and twelve months from baseline.
RESULTS


We could not show differential effects on the primary outcome between the intervention groups and the control group (p=.369, p=.934). Immediately after each intervention we could show beneficial time effects in all three groups on self-perceived cognitive deficits as well as on most of the other outcomes. The reported effects were however not sustained at 6 months follow-up.
CONCLUSIONS


Our findings could not show an additional effect of specific cognitive training on cognitive deficit perception in MS. However, findings indicate that MS rehabilitation may improve patient reported outcomes in the short term. They also underline the need for concepts to maintain rehabilitation gains when patients return back home.",2022,"We could not show differential effects on the primary outcome between the intervention groups and the control group (p=.369, p=.934).",['288 adult persons in three German rehab centers with a confirmed diagnosis of MS'],"['specific cognitive training', 'standardized metacognitive intervention (MaTiMS', 'specific neuropsychological interventions (1. metacognitive training (MaTiMS); 2. computerized working memory training (BrainStim) in combination with MaTiMS']","['cognitive deficit perception', 'Perceived cognitive deficits, mood, fatigue, coping, and activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]","[{'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",288.0,0.0488216,"We could not show differential effects on the primary outcome between the intervention groups and the control group (p=.369, p=.934).","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Pöttgen', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis (INIMS), Center for Molecular Neurobiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: j.poettgen@uke.de.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lau', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis (INIMS), Center for Molecular Neurobiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Stefan M', 'Initials': 'SM', 'LastName': 'Gold', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis (INIMS), Center for Molecular Neurobiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany; Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Medizinische Klinik m.S. Psychosomatik, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Letsch', 'Affiliation': 'Neurological Center Segeberger Kliniken, Bad Segeberg, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Bender', 'Affiliation': 'RehaCentrum Hamburg, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Flachenecker', 'Affiliation': 'Neurological Rehabilitation Center Quellenhof, Bad Wildbad, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heesen', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis (INIMS), Center for Molecular Neurobiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Iris-Katharina', 'Initials': 'IK', 'LastName': 'Penner', 'Affiliation': 'Department of Neurology, Medical Faculty, Heinrich Heine University Düsseldorf, Germany; Department of Neurology, Inselspital, University Hospital Bern, Switzerland.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2022.103687']
2251,35189571,Effects of a tongue training program in Parkinson's disease: Analysis of electrical activity and strength of suprahyoid muscles.,"OBJECTIVE


To assess the electrical activity of the suprahyoid muscle and the tongue pressure in a two-wing program of tongue strengthening in individuals with Parkinson's disease (PD).
METHODS


A pre-post-detraining design study included sixty PD patients assigned to two groups randomly. The experimental group (EG) performed tongue isometric pressure exercises using the Iowa Oral Performance Instrument with an increasing scheme of 5% load weekly and traditional tongue therapy for 8 weeks. The control group (CG) performed only traditional therapy. The electrical activity of suprahyoids was measured using surface electromyography (sEMG) during tongue-to-palate pressure. Four selected domains of the Swallowing Quality of Life Questionnaire (SWAL-QOL) mostly related to tongue strength were considered.
RESULTS


The experimental group showed increased sEMG values of suprahyoid muscles reaching statistically significant difference at the fourth week of tongue training, while the control did it at the eighth week. Experimental group showed significant improvements in tongue strength (d = 2.128; p = 0.000). Only controls showed detraining effect. Statistically significant difference within groups were found in one and three dimensions of the SWAL-QOL in the CG and EG, respectively.
CONCLUSION


Analysis of electrical activity on suprahyoids muscles provided a better understanding of the changes underlying the outcomes of tongue strength gains obtained through a combined tongue strengthening exercises protocol in PD. Such protocol led not only to increased tongue strength but also to a better perceived swallowing function in PD subjects.",2022,"Statistically significant difference within groups were found in one and three dimensions of the SWAL-QOL in the CG and EG, respectively.
","[""Parkinson's disease"", 'sixty PD patients assigned to two groups randomly', ""individuals with Parkinson's disease (PD""]","['control group (CG) performed only traditional therapy', 'tongue isometric pressure exercises using the Iowa Oral Performance Instrument with an increasing scheme of 5% load weekly and traditional tongue therapy', 'tongue training program']","['tongue strength', 'sEMG values of suprahyoid muscles', 'swallowing function', 'SWAL-QOL', 'Swallowing Quality of Life Questionnaire (SWAL-QOL', 'electrical activity of suprahyoids']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1744679', 'cui_str': 'Structure of suprahyoid muscle'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}]",60.0,0.0255678,"Statistically significant difference within groups were found in one and three dimensions of the SWAL-QOL in the CG and EG, respectively.
","[{'ForeName': 'Exequiel', 'Initials': 'E', 'LastName': 'Plaza', 'Affiliation': 'Department of Speech-Language Pathology and Audiology, Universidad de Talca, Talca, Chile. Electronic address: eplaza@utalca.cl.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ruviaro Busanello-Stella', 'Affiliation': 'Department of Speech-Language Pathology and Audiology, Universidade Federal de Santa Maria, Santa Maria, RS, Brazil.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2022.102642']
2252,35191232,Efficacy and Safety of Pregabalin for Muscle Cramps in Liver Cirrhosis: A Double-Blind Randomized Controlled Trial.,"BACKGROUND


Muscle cramp is possibly related to peripheral nerve hyperexcitability (PNH), and one of the most debilitating symptoms frequently encountered in patients with liver cirrhosis. We investigated whether pregabalin, a gamma-aminobutyric acid analogue, can suppress neuronal excitability and reduce muscle cramps in cirrhotic patients.
METHODS


We conducted a randomized, double-blind, placebo-controlled trial in which study participants with cirrhosis from a single tertiary center were enrolled. Primary endpoint was the relative change in cramp frequency from the run-in to standard dose treatment phase (4 weeks per each). Secondary endpoints included the responder rate, and the changes in cramp frequency during sleep, pain intensity, health-related quality of life (Liver Disease Quality of Life Instrument, Short Form-36) and electrophysiological measures of PNH.
RESULTS


This study was terminated early because of insufficient accrual. 80% (n = 56) of the target number of participants (n = 70) were randomized to pregabalin (n = 29) or placebo (n = 27). Median baseline frequency of muscle cramps (interquartile range) was 5.8 (3.5-10) per week in the pregabalin group and 6.5 (4.0-10) in the placebo group ( P  = 0.970). The primary analysis showed a significant reduction in cramp frequency with pregabalin compared to placebo (-36% vs. 4.5% for the percentage change,  P  = 0.010). Secondary outcomes did not differ significantly between the two groups. Adverse effects with pregabalin were mainly dizziness and lethargy.
CONCLUSION


With multiple problems emerging from premature termination in mind, the results suggested an acceptable safety profile and favorable effect of pregabalin in reducing muscle cramps compared to placebo in cirrhotic patients.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01271660.",2022,Secondary outcomes did not differ significantly between the two groups.,"['80% (n = 56) of the target number of participants (n = 70', 'Liver Cirrhosis', 'participants with cirrhosis from a single tertiary center were enrolled', 'patients with liver cirrhosis', 'cirrhotic patients']","['Pregabalin', 'placebo', 'pregabalin']","['responder rate, and the changes in cramp frequency during sleep, pain intensity, health-related quality of life (Liver Disease Quality of Life Instrument, Short Form-36) and electrophysiological measures of PNH', 'dizziness and lethargy', 'cramp frequency', 'relative change in cramp frequency', 'Median baseline frequency of muscle cramps', 'muscle cramps', 'Efficacy and Safety']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C0856984', 'cui_str': 'Hyperexcitation'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",70.0,0.882393,Secondary outcomes did not differ significantly between the two groups.,"[{'ForeName': 'Sohyun', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'Department of Neurology, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yoon-Ho', 'Initials': 'YH', 'LastName': 'Hong', 'Affiliation': 'Department of Neurology, Neuroscience Research Institute, Seoul National University Medical Research Council, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea. yhh@snu.ac.kr.'}, {'ForeName': 'Dong Hyeon', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sae Kyung', 'Initials': 'SK', 'LastName': 'Joo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yong Jin', 'Initials': 'YJ', 'LastName': 'Jung', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung-Yeon', 'Initials': 'SY', 'LastName': 'Sohn', 'Affiliation': 'Department of Neurology, Ajou University Medical Center, Ajou University College of Medicine, Suwon, Korea.'}, {'ForeName': 'Kyomin', 'Initials': 'K', 'LastName': 'Choi', 'Affiliation': 'Department of Neurology, Konkuk University Hospital, Konkuk University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea. drwon1@snu.ac.kr.'}]",Journal of Korean medical science,['10.3346/jkms.2022.37.e56']
2253,35192656,Maternal and infant morbidity following administration of repeat dexamethasone or betamethasone prior to preterm birth: A secondary analysis of the ASTEROID Trial.,"BACKGROUND


Clinical practice guidelines recommend administering antenatal corticosteroids (ACS), either betamethasone or dexamethasone, to women at risk of preterm birth at less than 35 weeks' gestation. If women remain at risk of preterm birth seven or more days after an initial course of ACS, most guidelines recommend administration of a repeat dose(s). No randomised trials have assessed the efficacy of dexamethasone as a repeat steroid compared to betamethasone.
AIM


We aimed to determine if there were differences between the use of dexamethasone or betamethasone as repeat ACS, for women who remain at risk of preterm birth after an initial course, on maternal, infant, and childhood health outcomes.
METHODS


We performed a secondary analysis of data from the ASTEROID randomised trial, where women at risk of preterm birth were allocated to either betamethasone or dexamethasone. Infant, childhood, and maternal outcomes were compared according to whether women received a repeat dose(s) of dexamethasone or betamethasone. The primary outcome was a composite outcome of death or any neurosensory disability at age two years (corrected for prematurity). The ASTEROID trial is registered with ANZCTR, ACTRN12608000631303.
RESULTS


168 women and their infants were included, with 86 women receiving dexamethasone and 82 women receiving betamethasone as a repeat dose. Women in the two ACS groups had similar baseline characteristics. We observed little to no difference in the incidence of death or any neurosensory disability at age two years (OR 0.89, 95% CI 0.39 to 2.06, p = 0.79) or in the incidence of other infant, childhood, and maternal adverse health outcomes between women who received dexamethasone and those who received betamethasone.
CONCLUSION


Use of dexamethasone for a repeat dose(s) compared to betamethasone did not result in any differences in infant, childhood, and maternal health outcomes. These results can be used to support clinical practice guideline recommendations.",2022,"We observed little to no difference in the incidence of death or any neurosensory disability at age two years (OR 0.89, 95% CI 0.39 to 2.06, p = 0.79) or in the incidence of other infant, childhood, and maternal adverse health outcomes between women who received dexamethasone and those who received betamethasone.
","[""women at risk of preterm birth at less than 35 weeks' gestation"", 'prior to preterm birth', 'and 82 women receiving', 'women at risk of preterm birth', 'women who remain at risk of preterm birth after an initial course, on maternal, infant, and childhood health outcomes', '168 women and their infants were included, with 86 women receiving']","['dexamethasone', 'dexamethasone or betamethasone', 'repeat dexamethasone or betamethasone', 'antenatal corticosteroids (ACS', 'betamethasone', 'betamethasone or dexamethasone']","['composite outcome of death or any neurosensory disability at age two years (corrected for prematurity', 'maternal adverse health outcomes', 'incidence of death or any neurosensory disability', 'Maternal and infant morbidity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",168.0,0.676015,"We observed little to no difference in the incidence of death or any neurosensory disability at age two years (OR 0.89, 95% CI 0.39 to 2.06, p = 0.79) or in the incidence of other infant, childhood, and maternal adverse health outcomes between women who received dexamethasone and those who received betamethasone.
","[{'ForeName': 'Olivia J', 'Initials': 'OJ', 'LastName': 'Hofer', 'Affiliation': 'Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Harding', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Thach', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': 'Osteoporosis and Bone Biology, Garvan Institute of Medical Research, Sydney, NSW, Australia.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}]",PloS one,['10.1371/journal.pone.0263927']
2254,35192655,Acceptability of an extended duration vaginal ring for HIV prevention and interest in a multi-purpose ring.,"Given challenges with adherence to existing HIV prevention products, the development of an extended duration vaginal ring could improve adherence while reducing patient and provider burden. Additionally, women have other interlinked sexual health concerns such as unintended pregnancy. We evaluated acceptability of a 90-day ring to prevent HIV and hypothetical preferences for a dual (HIV and contraceptive) indication. This was a secondary analysis of a Phase 1, two-arm, multi-site, placebo-controlled randomized trial evaluating safety and pharmacokinetics of a 90-day vaginal ring containing tenofovir for HIV prevention (N = 49). We used a mixed methods approach to assess quantitative data on acceptability (n = 49) and used qualitative data from a random subset to explain the quantitative findings (N = 25). The 3-month extended duration tenofovir ring was highly acceptable. Participants perceived the ring to be easy to use, comfortable and reported liking it more over time. About half felt the ring during sex but most of those participants said it bothered them only a little. Concerns about hygiene increased over the study period but were often outweighed by the benefits of an extended duration ring. Interest in a multi-purpose ring was high (77%) and even higher among those who were sexually active and had male partners. The 3-month extended duration tenofovir ring for HIV prevention was highly acceptable among women and interest in an MPT was high.",2022,Interest in a multi-purpose ring was high (77%) and even higher among those who were sexually active and had male partners.,[],['90-day vaginal ring containing tenofovir'],[],[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}]",[],,0.138732,Interest in a multi-purpose ring was high (77%) and even higher among those who were sexually active and had male partners.,"[{'ForeName': 'Marie C D', 'Initials': 'MCD', 'LastName': 'Stoner', 'Affiliation': ""Women's Global Health Imperative, RTI International, Berkeley, CA, United States of America.""}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Browne', 'Affiliation': ""Women's Global Health Imperative, RTI International, Berkeley, CA, United States of America.""}, {'ForeName': 'Holly M', 'Initials': 'HM', 'LastName': 'Gundacker', 'Affiliation': 'Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Hawley', 'Affiliation': ""Women's Global Health Imperative, RTI International, Berkeley, CA, United States of America.""}, {'ForeName': 'Beatrice A', 'Initials': 'BA', 'LastName': 'Chen', 'Affiliation': 'Magee-Womens Research Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Hoesley', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, United States of America.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Scheckter', 'Affiliation': 'FHI 360, Durham, NC, United States of America.'}, {'ForeName': 'Jeanna', 'Initials': 'J', 'LastName': 'Piper', 'Affiliation': 'US National Institutes of Health, Bethesda, MD, United States of America.'}, {'ForeName': 'Devika', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Magee-Womens Research Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Magee-Womens Research Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Bridge HIV, San Francisco Department of Public Health, San Francisco, CA, United States of America.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ""Women's Global Health Imperative, RTI International, Berkeley, CA, United States of America.""}]",PloS one,['10.1371/journal.pone.0263664']
2255,35192645,"Hyperbaric oxygen therapy improves symptoms, brain's microstructure and functionality in veterans with treatment resistant post-traumatic stress disorder: A prospective, randomized, controlled trial.","INTRODUCTION


Post-traumatic stress disorder (PTSD) is characterized by changes in both brain activity and microstructural integrity. Cumulative evidence demonstrates that hyperbaric oxygen therapy (HBOT) induces neuroplasticity and case-series studies indicate its potentially positive effects on PTSD. The aim of the study was to evaluate HBOT's effect in veterans with treatment resistant PTSD.
METHODS


Veterans with treatment resistant PTSD were 1:1 randomized to HBOT or control groups. All other brain pathologies served as exclusion criteria. Outcome measures included clinician-administered PTSD scale-V (CAPS-V) questionnaires, brief symptom inventory (BSI), BECK depression inventory (BDI), brain microstructural integrity evaluated by MRI diffuse tensor imaging sequence (DTI), and brain function was evaluated by an n-back task using functional MRI (fMRI). The treatment group underwent sixty daily hyperbaric sessions. No interventions were performed in the control group.
RESULTS


Thirty-five veterans were randomized to HBOT (N = 18) or control (n = 17) and 29 completed the protocol. Following HBOT, there was a significant improvement in CAPS-V scores and no change in the control (F = 30.57, P<0.0001, Net effect size = 1.64). Significant improvements were also demonstrated in BSI and BDI scores (F = 5.72, P = 0.024 Net effect size = 0.89, and F = 7.65, P = 0.01, Net effect size = 1.03). Improved brain activity was seen in fMRI in the left dorsolateral prefrontal, middle temporal gyri, both thalami, left hippocampus and left insula. The DTI showed significant increases in fractional anisotropy in the fronto-limbic white-matter, genu of the corpus callosum and fornix.
CONCLUSIONS


HBOT improved symptoms, brain microstructure and functionality in veterans with treatment resistant PTSD.",2022,"Improved brain activity was seen in fMRI in the left dorsolateral prefrontal, middle temporal gyri, both thalami, left hippocampus and left insula.","['Thirty-five veterans were randomized to HBOT (N = 18) or control (n = 17) and 29 completed the protocol', 'veterans with treatment resistant post-traumatic stress disorder', 'Veterans with treatment resistant PTSD', 'veterans with treatment resistant PTSD']","['hyperbaric oxygen therapy (HBOT', 'Hyperbaric oxygen therapy', 'HBOT']","[""HBOT's effect"", 'clinician-administered PTSD scale-V (CAPS-V) questionnaires, brief symptom inventory (BSI), BECK depression inventory (BDI), brain microstructural integrity evaluated by MRI diffuse tensor imaging sequence (DTI), and brain function was evaluated by an n-back task using functional MRI (fMRI', ""symptoms, brain's microstructure and functionality"", 'fractional anisotropy', 'CAPS-V scores', 'BSI and BDI scores', 'symptoms, brain microstructure and functionality', 'brain activity']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",35.0,0.0414908,"Improved brain activity was seen in fMRI in the left dorsolateral prefrontal, middle temporal gyri, both thalami, left hippocampus and left insula.","[{'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Doenyas-Barak', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center Zerifin, Zerifin, Israel.'}, {'ForeName': 'Merav', 'Initials': 'M', 'LastName': 'Catalogna', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center Zerifin, Zerifin, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Kutz', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center Zerifin, Zerifin, Israel.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Levi', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center Zerifin, Zerifin, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Hadanny', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center Zerifin, Zerifin, Israel.'}, {'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Tal', 'Affiliation': 'Sackler School of Medicine Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Shir', 'Initials': 'S', 'LastName': 'Daphna-Tekoha', 'Affiliation': 'Kaplan Medical Center, Rehovot, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Sasson', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center Zerifin, Zerifin, Israel.'}, {'ForeName': 'Yarden', 'Initials': 'Y', 'LastName': 'Shechter', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center Zerifin, Zerifin, Israel.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Efrati', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center Zerifin, Zerifin, Israel.'}]",PloS one,['10.1371/journal.pone.0264161']
2256,35194005,Efficacy and safety of obinutuzumab for the first-line treatment of follicular lymphoma: a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study.,"BACKGROUNDS


GALLIUM is a global phase III study that demonstrated significant improvements in progression-free survival (PFS) for obinutuzumab plus chemotherapy (G-chemo) vs. rituximab plus chemotherapy (R-chemo) in previously untreated patients with follicular lymphoma (FL). This study aimed to report the results of a subgroup of patients in China.
METHODS


Patients were randomized to G-chemo or R-chemo. Responders received maintenance therapy for 2 years or until disease progression. The primary endpoint was investigator (INV)-assessed PFS. Secondary endpoints included the overall response rate (ORR) and complete response rate (CRR) at the end of induction chemotherapy, overall survival (OS), and safety.
RESULTS


Overall, 58 patients with FL were randomized to the G-chemo (n = 25) and R-chemo arms (n = 33). The INV-assessed PFS rate at 3 years was 81.8% in the G-chemo arm, vs. 70.2% in the R-chemo arm (hazard ratio 0.35; 95% confidence interval: 0.09-1.34; P = 0.1120). The INV-assessed CRRs (without positron emission tomography [PET]) in these arms were 24.0% and 21.2%, respectively, whereas the ORRs were 80.0% and 90.9%, respectively. INV-assessed CRR-PET was 52.6% in the G-chemo, vs. 60.9% in the R-chemo. Median OS was not reached in either arm. Grade 3 to 5 adverse events were more frequent in the R-chemo arm (97.0% vs. 88.0%).
CONCLUSIONS


The results of this subgroup analysis were consistent with those of the global population, and they suggest that G-chemo has a positive benefit-risk profile in patients from China with FL.
TRIAL REGISTRATION


ClinicalTrials.gov, No. NCT01332968.",2021,"INV-assessed CRR-PET was 52.6% in the G-chemo, vs. 60.9% in the R-chemo.","['subgroup of patients in China', '58 patients with FL', 'Patients', 'previously untreated patients with follicular lymphoma (FL', 'follicular lymphoma', 'Chinese patients enrolled in the phase III GALLIUM study']","['maintenance therapy', 'obinutuzumab plus chemotherapy (G-chemo) vs. rituximab plus chemotherapy (R-chemo', 'G-chemo', 'G-chemo or R-chemo', 'obinutuzumab']","['Efficacy and safety', 'ORRs', 'progression-free survival (PFS', 'investigator (INV)-assessed PFS', 'Grade 3 to 5 adverse events', 'INV-assessed PFS rate', 'overall response rate (ORR) and complete response rate (CRR) at the end of induction chemotherapy, overall survival (OS), and safety', 'INV-assessed CRRs (without positron emission tomography [PET', 'INV-assessed CRR-PET', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0016980', 'cui_str': 'Gallium'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",58.0,0.284119,"INV-assessed CRR-PET was 52.6% in the G-chemo, vs. 60.9% in the R-chemo.","[{'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.'}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing 100142, China.'}, {'ForeName': 'Yuankai', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing 100021, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin Medical University, Harbin, Heilongjiang 150081, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Department of Hematology, The First Hospital of Jilin University, Changchun, Jilin 130015, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Oncology, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430023, China.'}, {'ForeName': 'Junmin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital, Nanjing Medical University Affiliated Cancer Hospital, Nanjing, Jiangsu 210009, China.'}, {'ForeName': 'Anastasiia', 'Initials': 'A', 'LastName': 'Kinkolykh', 'Affiliation': 'Consultant to F. Hoffmann-La Roche Ltd, Basel, Switzerland, via GCE Solutions - an IQVIA business, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Knapp', 'Affiliation': 'Product Development Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Tongyu', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, and Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong 510075, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000001737']
2257,35195610,"A Randomized, Double-Blinded, Placebo-Controlled Trial of Simvastatin to Prevent Recurrent Pancreatitis.",,2022,,[],"['Placebo', 'Simvastatin']",['Recurrent Pancreatitis'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0149521', 'cui_str': 'Chronic pancreatitis'}]",,0.976844,,"[{'ForeName': 'Marc T', 'Initials': 'MT', 'LastName': 'Goodman', 'Affiliation': ''}, {'ForeName': 'Simon K', 'Initials': 'SK', 'LastName': 'Lo', 'Affiliation': ''}, {'ForeName': 'Dhiraj', 'Initials': 'D', 'LastName': 'Yadav', 'Affiliation': ''}, {'ForeName': 'Bechien U', 'Initials': 'BU', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Laith H', 'Initials': 'LH', 'LastName': 'Jamil', 'Affiliation': ''}, {'ForeName': 'Karl K', 'Initials': 'KK', 'LastName': 'Kwok', 'Affiliation': ''}, {'ForeName': 'Georgios I', 'Initials': 'GI', 'LastName': 'Papachristou', 'Affiliation': ''}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Afghani', 'Affiliation': ''}, {'ForeName': 'Yunhee', 'Initials': 'Y', 'LastName': 'Choi-Kuaea', 'Affiliation': ''}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Waldron', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lombardi', 'Affiliation': ''}, {'ForeName': 'Christie Y', 'Initials': 'CY', 'LastName': 'Jeon', 'Affiliation': ''}, {'ForeName': 'Irene B', 'Initials': 'IB', 'LastName': 'Helenowski', 'Affiliation': ''}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Richmond', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Benante', 'Affiliation': ''}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Habtezion', 'Affiliation': ''}, {'ForeName': 'Tia', 'Initials': 'T', 'LastName': 'Schering', 'Affiliation': ''}, {'ForeName': 'Seema A', 'Initials': 'SA', 'LastName': 'Khan', 'Affiliation': ''}, {'ForeName': 'Luz M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': ''}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Pandol', 'Affiliation': ''}]",Pancreas,['10.1097/MPA.0000000000001955']
2258,35196759,[Preventing and treating anterior commissure adhesion with mucosal flap: a study in canines and clinical cases].,"Objective:  To evaluate the effectiveness of mucosal flap combined with silicone keel for preventing and treating anterior commissure adhesion in canines and clinical cases.  Methods:  A prospective experiment was performed from November 2019 to June 2021. Twenty five canines were randomly divided into 5 groups(A, B, C, D, E). Group A, B, C, D received anterior commissure injury by CO 2  laser, then separately treated with free mucosal flap-keel complex,intralaryngeal mucosal flap-keel complex, silicone keels and without treatment, group E didn't injure the vocal cord after intubation. The keel was removed after 2 weeks, the larynx was harvested after 4 weeks. The effectiveness of anterior commissure adhesion prevention was evaluated by manifestation under laryngoscope, standard vocal cord length and standard glottic area. A retrospective analysis was performed on sixteen patients with anterior commissure lesion, who underwent mucosal flap-keel technique in Huashan Hospital of Fudan University from January 2019 to January 2021 (10 cases with free mucosal flap-keel complex and 6 cases with intralaryngeal mucosal flap-keel complex). All the patients underwent evaluation of laryngeal function included manifestation under laryngoscope each month and voice analysis before and 3 month after surgery. SPSS 20.0 software was used for statistical analysis.  Results:  No surgery accident or complication happened in canines and patients. The standard vocal cord length and standard glottic area after 4 weeks in group B were significantly higher than those in group A, C, D ( H standard vocal cord length =31.688,  H standard glottic area =16.444,  P <0.05). The standard vocal cord length and standard glottic area after 4 weeks in group A were also significantly higher than those in group C, D( H standard vocal cord length =20.936,  H standard glottic area =11.786,  P <0.05). The standard vocal cord length and standard glottic area after 4 weeks in group A, B, E were not significantly different to that before surgery( t A left standard vocal cord length =2.636,  t A right standard vocal cord length =2.582,  t B left standard vocal cord length =2.707,  t B right standard vocal cord length =2.673,  t E left standard vocal cord length =0.370,  t E right standard vocal cord length =0.821,  t A standard glottic area =2.731,  t B standard glottic area =2.753,  t E standard glottic area =-0.529,  P >0.05). The standard vocal cord length and standard glottic area after 4 weeks in group C, D were significantly lower than those before surgery( t C left standard vocal cord length =16.137,  t C right standard vocal cord length =13.984,  t D left standard vocal cord length =11.903,  t D right standard vocal cord length =14.587,  t C standard glottic area =10.280,  t D standard glottic area =22.974,  P <0.05). During 6-18 months of follow-up in clinical patients, no one developed a glottic web. Three months after surgery, Jitter, Shimmer, noise to harmonic ratio(NHR), the maximum phonation time(MPT)in all patients were significantly different from preoperative( t intralaryngeal mucosal flap jitter =24.885,  t intralaryngeal mucosal flap shimmer =22.643,  t intralaryngeal mucosal flap NHR =6.202,  t intralaryngeal mucosal flap MPT =-9.661,  t free mucosal flap jitter =25.459,  t free mucosal flap shimmer =18.683,  t free mucosal flap NHR =5.705,  t free mucosal flap MPT =-20.840,  P <0.05).  Conclusion:  Mucosal flap combined with silicone keel is an effective technique for preventing and treating anterior commissure adhesion. The effect of pedicled intralaryngea lmucosal flap is better.",2022,"Three months after surgery, Jitter, Shimmer, noise to harmonic ratio(NHR), the maximum phonation time(MPT)in all patients were significantly different from preoperative( t intralaryngeal mucosal flap jitter =24.885,  t intralaryngeal mucosal flap shimmer =22.643,  ","['November 2019 to June 2021', 'Twenty five canines', 'sixteen patients with anterior commissure lesion, who underwent mucosal flap-keel technique in Huashan Hospital of Fudan University from January 2019 to January 2021 (10 cases with free mucosal flap-keel complex and 6 cases with intralaryngeal mucosal flap-keel complex', 'canines and clinical cases']","['mucosal flap combined with silicone keel', 'Mucosal flap combined with silicone keel', 'mucosal flap', ""anterior commissure injury by CO 2  laser, then separately treated with free mucosal flap-keel complex,intralaryngeal mucosal flap-keel complex, silicone keels and without treatment, group E didn't injure the vocal cord after intubation"", 'pedicled intralaryngea lmucosal flap']","['manifestation under laryngoscope, standard vocal cord length and standard glottic area', 'standard vocal cord length and standard glottic area']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152335', 'cui_str': 'Structure of anterior commissure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0729268', 'cui_str': 'Mucosal flap'}, {'cui': 'C0441591', 'cui_str': 'Keeling - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0729268', 'cui_str': 'Mucosal flap'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0441591', 'cui_str': 'Keeling - action'}, {'cui': 'C0152335', 'cui_str': 'Structure of anterior commissure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441839', 'cui_str': 'Group E'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",16.0,0.063498,"Three months after surgery, Jitter, Shimmer, noise to harmonic ratio(NHR), the maximum phonation time(MPT)in all patients were significantly different from preoperative( t intralaryngeal mucosal flap jitter =24.885,  t intralaryngeal mucosal flap shimmer =22.643,  ","[{'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Huashan Hospital of Fudan University, Shanghai 200040, China.'}, {'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Huashan Hospital of Fudan University, Shanghai 200040, China.'}, {'ForeName': 'X D', 'Initials': 'XD', 'LastName': 'Cui', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Huashan Hospital of Fudan University, Shanghai 200040, China.'}, {'ForeName': 'X Q', 'Initials': 'XQ', 'LastName': 'Hu', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Huashan Hospital of Fudan University, Shanghai 200040, China.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Yu', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Huashan Hospital of Fudan University, Shanghai 200040, China.'}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Sun', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Huashan Hospital of Fudan University, Shanghai 200040, China.'}]",Zhonghua er bi yan hou tou jing wai ke za zhi = Chinese journal of otorhinolaryngology head and neck surgery,['10.3760/cma.j.cn115330-20210415-00204']
2259,35197106,A multiple technology-based physical activity intervention for Latina adolescents in the USA: randomized controlled trial study protocol for Chicas Fuertes.,"BACKGROUND


Latina adolescents in the USA report some of the lowest rates of physical activity of any demographic subgroup; this is paralleled by a markedly higher lifetime risk of obesity, type 2 diabetes, and other conditions related to inactivity. Despite this, to date, no fully powered clinical trials have tested physical activity interventions specifically for this population. High use of mobile technologies (including text messages, smartphone apps, and social media) suggests this could be an appropriate intervention channel, while also having potential for broad reach. This paper describes the protocol for Chicas Fuertes, a fully powered randomized trial of a mobile technology-based physical activity intervention for Latina adolescents.
METHODS


We plan to recruit 200 Latina teens (age 13-18) in San Diego, CA, currently engaging in ≤ 150 min/week of moderate-to-vigorous physical activity (MVPA) to be assigned 1:1 to the intervention or control groups. Those randomly assigned to the intervention group receive a one-on-one goal setting session followed by 6 months of mobile technology-based intervention, including a personalized website, Fitbit activity tracker and app, individually tailored text messages based on Fitbit data, and daily intervention content on Instagram. Those randomized to the control group receive only a Fitbit activity tracker. The main outcome is change in weekly minutes of MVPA from baseline to 6 months, measured both objectively (ActiGraph accelerometers and Fitbit Inspire HR) and subjectively (7-Day Physical Activity Recall Interview). Additional outcomes are maintenance of activity change at 12 months and changes in psychosocial constructs, including social support and self-efficacy, engagement with mobile technology channels, and costs of intervention delivery. We are also examining the potential mediators and moderators of the intervention. The efficacy of the intervention is analyzed using a mixed effects regression model, adjusting for any potential confounders not balanced by randomization. All analyses of accelerometer measured MVPA are also adjusted for wear time.
DISCUSSION


The Chicas Fuertes trial uses widely available mobile technologies to target critical health behavior, physical activity, in Latina teens, a population with a high lifetime risk of lifestyle-related diseases. The results will speak to the efficacy and acceptability of the intervention, which has the potential for broad dissemination.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04190225 . Registered on November 20, 2019.",2022,"Additional outcomes are maintenance of activity change at 12 months and changes in psychosocial constructs, including social support and self-efficacy, engagement with mobile technology channels, and costs of intervention delivery.","['200 Latina teens (age 13-18) in', 'Latina adolescents', 'Latina adolescents in the USA']","['mobile technology-based physical activity intervention', 'intervention group receive a one-on-one goal setting session followed by 6 months of mobile technology-based intervention, including a personalized website, Fitbit activity tracker and app, individually tailored text messages based on Fitbit data, and daily intervention content on Instagram', 'San Diego, CA, currently engaging in ≤ 150\u2009min/week of moderate-to-vigorous physical activity (MVPA', 'Fitbit activity tracker', 'multiple technology-based physical activity intervention']","['maintenance of activity change', 'objectively (ActiGraph accelerometers and Fitbit Inspire HR) and subjectively (7-Day Physical Activity Recall Interview', 'psychosocial constructs, including social support and self-efficacy, engagement with mobile technology channels, and costs of intervention delivery', 'change in weekly minutes of MVPA']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.0846239,"Additional outcomes are maintenance of activity change at 12 months and changes in psychosocial constructs, including social support and self-efficacy, engagement with mobile technology channels, and costs of intervention delivery.","[{'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Larsen', 'Affiliation': 'Herbert Wertheim School of Public Health & Human Longevity Science, UC San Diego, La Jolla, CA, USA. blarsen@health.ucsd.edu.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Greenstadt', 'Affiliation': 'Herbert Wertheim School of Public Health & Human Longevity Science, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Olesen', 'Affiliation': 'Herbert Wertheim School of Public Health & Human Longevity Science, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Lilliana', 'Initials': 'L', 'LastName': 'Osuna', 'Affiliation': 'Herbert Wertheim School of Public Health & Human Longevity Science, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'Godino', 'Affiliation': 'Herbert Wertheim School of Public Health & Human Longevity Science, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University, Providence, RI, USA.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University, Providence, RI, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Meyer', 'Affiliation': 'Department of Neurosciences, School of Medicine, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Zive', 'Affiliation': 'Herbert Wertheim School of Public Health & Human Longevity Science, UC San Diego, La Jolla, CA, USA.'}]",Trials,['10.1186/s13063-022-06105-2']
2260,35197100,"Study protocol for a cluster randomized trial of a school, family, and community intervention for preventing drug misuse among older adolescents in the Cherokee Nation.","BACKGROUND


The national opioid crisis has disproportionately burdened rural White populations and American Indian/Alaska Native (AI/AN) populations. Therefore, Cherokee Nation and Emory University public health scientists have designed an opioid prevention trial to be conducted in rural communities in the Cherokee Nation (northeast Oklahoma) with AI and other (mostly White) adolescents and young adults. Our goal is to implement and evaluate a theory-based, integrated multi-level community intervention designed to prevent the onset and escalation of opioid and other drug misuse. Two distinct intervention approaches-community organizing, as implemented in our established Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral, as implemented in our established Connect intervention protocol-will be integrated with skill-based training for adults to strengthen social support for youth and also with strategic media. Furthermore, we will test systems for sustained implementation within existing organizational structures of the Cherokee Nation and local schools and communities. This study protocol describes the cluster randomized trial, designed to measure implementation and evaluate the effectiveness on primary and secondary outcomes.
METHODS


Using a cluster randomized controlled design and constrained randomization, this trial will allocate 20 high schools and surrounding communities to either an intervention or delayed-intervention comparison condition. With a proposed sample of 20 high schools, all enrolled 10th grade students in fall 2021 (ages 15 to 17) will be eligible for participation. During the trial, we will (1) implement interventions through the Cherokee Nation and measure implementation processes and fidelity, (2) measure opioid and other drug use and secondary outcomes every 6 months among a cohort of high school students followed over 3 years through their transition out of high school, (3) test via a cluster randomized trial the effect of the integrated CMCA-Connect intervention, and (4) analyze implementation costs. Primary outcomes include the number of days during the past 30 days of (1) any alcohol use, (2) heavy alcohol use (defined as having at least four, among young women, or five, among young men, standard alcoholic drinks within a couple of hours), (3) any marijuana use, and (4) prescription opioid misuse (defined as ""without a doctor's prescription or differently than how a doctor or medical provider told you to use it"").
DISCUSSION


This trial will expand upon previous research advancing the scientific evidence regarding prevention of opioid and other drug misuse during the critical developmental period of late adolescent transition to young adulthood among a sample of American Indian and other youth living within the Cherokee Nation reservation.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04839978 . Registered on April 9, 2021. Version 4, January 26, 2022.",2022,"Two distinct intervention approaches-community organizing, as implemented in our established Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral, as implemented in our established Connect intervention protocol-will be integrated with skill-based training for adults to strengthen social support for youth and also with strategic media.","['20 high schools, all enrolled 10th grade students in fall 2021 (ages 15 to 17) will be eligible for participation', 'rural communities in the Cherokee Nation (northeast Oklahoma) with AI and other (mostly White) adolescents and young adults', '20 high schools and surrounding communities to either an intervention or delayed-intervention comparison condition', 'older adolescents in the Cherokee Nation', 'young men, standard alcoholic drinks within a couple of hours), (3) any marijuana use, and (4) prescription opioid misuse (defined as ""without a doctor\'s prescription or differently than how a doctor or medical provider told you to use it']","['community intervention', 'integrated CMCA-Connect intervention', 'Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral']","['number of days during the past 30\u2009days of (1) any alcohol use, (2) heavy alcohol use']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0574551', 'cui_str': 'Cherokee language'}, {'cui': 'C0028914', 'cui_str': 'Oklahoma'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]",20.0,0.0398283,"Two distinct intervention approaches-community organizing, as implemented in our established Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral, as implemented in our established Connect intervention protocol-will be integrated with skill-based training for adults to strengthen social support for youth and also with strategic media.","[{'ForeName': 'Kelli A', 'Initials': 'KA', 'LastName': 'Komro', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, 30322, USA. kkomro@emory.edu.'}, {'ForeName': 'Terrence K', 'Initials': 'TK', 'LastName': 'Kominsky', 'Affiliation': 'Cherokee Nation Behavioral Health, 19600 N. Ross St, Tahlequah, OK, 74464, USA.'}, {'ForeName': 'Juli R', 'Initials': 'JR', 'LastName': 'Skinner', 'Affiliation': 'Cherokee Nation Behavioral Health, 19600 N. Ross St, Tahlequah, OK, 74464, USA.'}, {'ForeName': 'Melvin D', 'Initials': 'MD', 'LastName': 'Livingston', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Bethany J', 'Initials': 'BJ', 'LastName': 'Livingston', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Avance', 'Affiliation': 'Cherokee Nation Behavioral Health, 19600 N. Ross St, Tahlequah, OK, 74464, USA.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Lincoln', 'Affiliation': 'Cherokee Nation Behavioral Health, 19600 N. Ross St, Tahlequah, OK, 74464, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Barry', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Walker', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Dallas W', 'Initials': 'DW', 'LastName': 'Pettigrew', 'Affiliation': 'College of Arts and Sciences, Anne and Henry Zarrow School of Social Work, University of Oklahoma, Tulsa, USA.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Merlo', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Florida, Gainesville, USA.'}, {'ForeName': 'Hannah L F', 'Initials': 'HLF', 'LastName': 'Cooper', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Wagenaar', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, 30322, USA.'}]",Trials,['10.1186/s13063-022-06096-0']
2261,35197097,Development and validation of a risk prediction model for postoperative pneumonia in adult patients undergoing Stanford type A acute aortic dissection surgery: a case control study.,"BACKGROUND


Pneumonia is a common complication after Stanford type A acute aortic dissection surgery (AADS) and contributes significantly to morbidity, mortality, and length of stay. The purpose of this study was to identify independent risk factors associated with pneumonia after AADS and to develop and validate a risk prediction model.
METHODS


Adults undergoing AADS between 2016 and 2019 were identified in a single-institution database. Patients were randomly divided into training and validation sets at a ratio of 2:1. Preoperative and intraoperative variables were included for analysis. A multivariate logistic regression model was constructed using significant variables from univariate analysis in the training set. A nomogram was constructed for clinical utility and the model was validated in an independent dataset.
RESULTS


Postoperative pneumonia developed in 170 of 492 patients (34.6%). In the training set, multivariate analysis identified seven independent predictors for pneumonia after AADS including age, smoking history, chronic obstructive pulmonary disease, renal insufficiency, leucocytosis, low platelet count, and intraoperative transfusion of red blood cells. The model demonstrated good calibration (Hosmer-Lemeshow χ 2  = 3.31, P = 0.91) and discrimination (C-index = 0.77) in the training set. The model was also well calibrated (Hosmer-Lemeshow χ 2  = 5.73, P = 0.68) and showed reliable discriminatory ability (C-index = 0.78) in the validation set. By visual inspection, the calibrations were good in both the training and validation sets.
CONCLUSION


We developed and validated a risk prediction model for pneumonia after AADS. The model may have clinical utility in individualized risk evaluation and perioperative management.",2022,"The model was also well calibrated (Hosmer-Lemeshow χ 2  = 5.73, P = 0.68) and showed reliable discriminatory ability (C-index = 0.78) in the validation set.","['Adults undergoing AADS between 2016 and 2019 were identified in a single-institution database', 'adult patients undergoing Stanford type A acute aortic dissection surgery']",[],"['Postoperative pneumonia', 'morbidity, mortality, and length of stay', 'smoking history, chronic obstructive pulmonary disease, renal insufficiency, leucocytosis, low platelet count, and intraoperative transfusion of red blood cells']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0340643', 'cui_str': 'Dissection of aorta'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C1279386', 'cui_str': 'Postoperative pneumonia'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0023518', 'cui_str': 'Leukocytosis'}, {'cui': 'C0392386', 'cui_str': 'Platelet count below reference range'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}]",,0.0418546,"The model was also well calibrated (Hosmer-Lemeshow χ 2  = 5.73, P = 0.68) and showed reliable discriminatory ability (C-index = 0.78) in the validation set.","[{'ForeName': 'Dashuai', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Jiefang Road, No. 1277, Wuhan, 430022, China.'}, {'ForeName': 'Xiaerzhati', 'Initials': 'X', 'LastName': 'Abuduaini', 'Affiliation': 'Department of Cardiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiaofan', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiovascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Jiefang Road, No. 1277, Wuhan, 430022, China. dr_xfhuang@hust.edu.cn.'}, {'ForeName': 'Hongfei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Jiefang Road, No. 1277, Wuhan, 430022, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Jiefang Road, No. 1277, Wuhan, 430022, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Le', 'Affiliation': 'Department of Cardiovascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Jiefang Road, No. 1277, Wuhan, 430022, China.'}, {'ForeName': 'Manhua', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. chenmh@aliyun.com.'}, {'ForeName': 'Xinling', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of Cardiovascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Jiefang Road, No. 1277, Wuhan, 430022, China. xinlingdu@hust.edu.cn.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-022-01769-y']
2262,35197082,"CeRebrUm and CardIac Protection with ALlopurinol in Neonates with Critical Congenital Heart Disease Requiring Cardiac Surgery with Cardiopulmonary Bypass (CRUCIAL): study protocol of a phase III, randomized, quadruple-blinded, placebo-controlled, Dutch multicenter trial.","BACKGROUND


Neonates with critical congenital heart disease (CCHD) undergoing cardiac surgery with cardiopulmonary bypass (CPB) are at risk of brain injury that may result in adverse neurodevelopment. To date, no therapy is available to improve long-term neurodevelopmental outcomes of CCHD neonates. Allopurinol, a xanthine oxidase inhibitor, prevents the formation of reactive oxygen and nitrogen species, thereby limiting cell damage during reperfusion and reoxygenation to the brain and heart. Animal and neonatal studies suggest that allopurinol reduces hypoxic-ischemic brain injury and is cardioprotective and safe. This trial aims to test the hypothesis that allopurinol administration in CCHD neonates will result in a 20% reduction in moderate to severe ischemic and hemorrhagic brain injury.
METHODS


This is a phase III, randomized, quadruple-blinded, placebo-controlled, multicenter trial. Neonates with a prenatal or postnatal CCHD diagnosis requiring cardiac surgery with CPB in the first 4 weeks after birth are eligible to participate. Allopurinol or mannitol-placebo will be administered intravenously in 2 doses early postnatally in neonates diagnosed antenatally and 3 doses perioperatively of 20 mg/kg each in all neonates. The primary outcome is a composite endpoint of moderate/severe ischemic or hemorrhagic brain injury on early postoperative MRI, being too unstable for postoperative MRI, or mortality within 1 month following CPB. A total of 236 patients (n = 188 with prenatal diagnosis) is required to demonstrate a reduction of the primary outcome incidence by 20% in the prenatal group and by 9% in the postnatal group (power 80%; overall type 1 error controlled at 5%, two-sided), including 1 interim analysis at n = 118 (n = 94 with prenatal diagnosis) with the option to stop early for efficacy. Secondary outcomes include preoperative and postoperative brain injury severity, white matter injury volume (MRI), and cardiac function (echocardiography); postnatal and postoperative seizure activity (aEEG) and regional cerebral oxygen saturation (NIRS); neurodevelopment at 3 months (general movements); motor, cognitive, and language development and quality of life at 24 months; and safety and cost-effectiveness of allopurinol.
DISCUSSION


This trial will investigate whether allopurinol administered directly after birth and around cardiac surgery reduces moderate/severe ischemic and hemorrhagic brain injury and improves cardiac function and neurodevelopmental outcome in CCHD neonates.
TRIAL REGISTRATION


EudraCT 2017-004596-31. Registered on November 14, 2017. ClinicalTrials.gov NCT04217421. Registered on January 3, 2020.",2022,"A total of 236 patients (n = 188 with prenatal diagnosis) is required to demonstrate a reduction of the primary outcome incidence by 20% in the prenatal group and by 9% in the postnatal group (power 80%; overall type 1 error controlled at 5%, two-sided), including 1 interim analysis at n = 118 (n = 94 with prenatal diagnosis) with the option to stop early for efficacy.","['Neonates with a prenatal or postnatal CCHD diagnosis requiring cardiac surgery with CPB in the first 4\u2009weeks after birth are eligible to participate', 'neonates diagnosed antenatally and 3 doses perioperatively of 20\u2009mg/kg each in all neonates', 'CCHD neonates', 'Neonates with critical congenital heart disease (CCHD) undergoing cardiac surgery with', '236 patients (n = 188 with prenatal diagnosis', 'Neonates with Critical Congenital Heart Disease Requiring Cardiac Surgery with Cardiopulmonary Bypass (CRUCIAL']","['placebo', 'Allopurinol or mannitol-placebo', 'Allopurinol', 'ALlopurinol', 'EudraCT', 'cardiopulmonary bypass (CPB', 'allopurinol']","['preoperative and postoperative brain injury severity, white matter injury volume (MRI), and cardiac function (echocardiography); postnatal and postoperative seizure activity (aEEG) and regional cerebral oxygen saturation (NIRS); neurodevelopment at 3\u2009months (general movements); motor, cognitive, and language development and quality of life at 24\u2009months; and safety and cost-effectiveness of allopurinol', 'cardiac function and neurodevelopmental outcome', 'composite endpoint of moderate/severe ischemic or hemorrhagic brain injury on early postoperative MRI, being too unstable for postoperative MRI, or mortality within 1\u2009month following CPB']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033053', 'cui_str': 'Intrauterine Diagnosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0023013', 'cui_str': 'Language Development'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]",236.0,0.636105,"A total of 236 patients (n = 188 with prenatal diagnosis) is required to demonstrate a reduction of the primary outcome incidence by 20% in the prenatal group and by 9% in the postnatal group (power 80%; overall type 1 error controlled at 5%, two-sided), including 1 interim analysis at n = 118 (n = 94 with prenatal diagnosis) with the option to stop early for efficacy.","[{'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Stegeman', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center (UMC) Utrecht, Utrecht University, KE 04.123.1, PO Box 85909, 3508, AB, Utrecht, The Netherlands.""}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Nijman', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center (UMC) Utrecht, Utrecht University, KE 04.123.1, PO Box 85909, 3508, AB, Utrecht, The Netherlands.""}, {'ForeName': 'Johannes M P J', 'Initials': 'JMPJ', 'LastName': 'Breur', 'Affiliation': ""Department of Pediatric Cardiology, Wilhelmina Children's Hospital, UMC Utrecht, Utrecht University, Utrecht, The Netherlands.""}, {'ForeName': 'Floris', 'Initials': 'F', 'LastName': 'Groenendaal', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center (UMC) Utrecht, Utrecht University, KE 04.123.1, PO Box 85909, 3508, AB, Utrecht, The Netherlands.""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Haas', 'Affiliation': ""Congenital Cardiothoracic Surgery, Wilhelmina Children's Hospital, UMC Utrecht, Utrecht University, Utrecht, The Netherlands.""}, {'ForeName': 'Jan B', 'Initials': 'JB', 'LastName': 'Derks', 'Affiliation': ""Department of Obstetrics, Wilhelmina Children's Hospital, UMC Utrecht, Utrecht University, Utrecht, The Netherlands.""}, {'ForeName': 'Joppe', 'Initials': 'J', 'LastName': 'Nijman', 'Affiliation': ""Department of Pediatric Intensive Care, Wilhelmina Children's Hospital, UMC Utrecht, Utrecht University, Utrecht, The Netherlands.""}, {'ForeName': 'Ingrid M', 'Initials': 'IM', 'LastName': 'van Beynum', 'Affiliation': ""Department of Pediatrics, Division of Pediatric Cardiology, Academic Center for Congenital Heart Disease, Erasmus Medical Center (MC) - Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Yannick J H J', 'Initials': 'YJHJ', 'LastName': 'Taverne', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus MC, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Ad J J C', 'Initials': 'AJJC', 'LastName': 'Bogers', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus MC, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Helbing', 'Affiliation': ""Department of Pediatrics, Division of Pediatric Cardiology, Academic Center for Congenital Heart Disease, Erasmus Medical Center (MC) - Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Willem P', 'Initials': 'WP', 'LastName': 'de Boode', 'Affiliation': ""Department of Neonatology, Radboudumc, Radboud Institute for Health Sciences, Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'Arend F', 'Initials': 'AF', 'LastName': 'Bos', 'Affiliation': ""Division of Neonatology, Beatrix Children's Hospital, UMC Groningen, University of Groningen, Groningen, The Netherlands.""}, {'ForeName': 'Rolf M F', 'Initials': 'RMF', 'LastName': 'Berger', 'Affiliation': ""Center for Congenital Heart Diseases, Pediatric Cardiology, Beatrix Children's Hospital, UMC Groningen, University of Groningen, Groningen, The Netherlands.""}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Accord', 'Affiliation': 'Center for Congenital Heart Diseases, Department of Cardiothoracic Surgery, UMC Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Kit C B', 'Initials': 'KCB', 'LastName': 'Roes', 'Affiliation': 'Department of Health Evidence, Section Biostatistics, Radboudumc, Radboud University Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'G Ardine', 'Initials': 'GA', 'LastName': 'de Wit', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Nicolaas J G', 'Initials': 'NJG', 'LastName': 'Jansen', 'Affiliation': ""Department of Pediatric Intensive Care, Wilhelmina Children's Hospital, UMC Utrecht, Utrecht University, Utrecht, The Netherlands.""}, {'ForeName': 'Manon J N L', 'Initials': 'MJNL', 'LastName': 'Benders', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center (UMC) Utrecht, Utrecht University, KE 04.123.1, PO Box 85909, 3508, AB, Utrecht, The Netherlands. M.Benders@umcutrecht.nl.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-022-06098-y']
2263,35204048,Mindfulness-Based Interventions and Body Awareness.,"Body awareness (BA) has long been proposed as a working mechanism of mindfulness-based interventions (MBIs), yet research on the mediating role of BA is scarce. Hence, the present study assesses the impact of an 8-week MBI on self-reported and indirect measures of BA, investigates the potential mediating role of BA in the relationship between an MBI and symptomatology, evaluates the impact of an MBI on important psychological processes (i.e., experiential avoidance, rumination, self-efficacy, and self-discrepancy), and explores whether these variables act alongside BA in mediating the relationship between an MBI and symptomatology. A non-randomized controlled trial was conducted with 148 participants ( n  = 89 in the MBI group;  n  = 59 in the control group) who completed questionnaires assessing BA and the above-mentioned psychological processes before and after an MBI. A sub-sample of participants ( n  = 86) completed a task that evaluates BA indirectly. Results showed a significant effect of MBI on the self-reported BA but not on the indirect measure of BA. The MBI significantly reduced symptomatology, and this effect was mediated by regulatory and belief-related dimensions of BA. Multiple mediator models showed a significant mediation via various pathways involving improved BA and various transdiagnostic psychological processes.",2022,"The MBI significantly reduced symptomatology, and this effect was mediated by regulatory and belief-related dimensions of BA.",['148 participants ( n  = 89 in the MBI group;  n  = 59 in the control group) who completed questionnaires assessing BA and the above-mentioned psychological processes before and after an MBI'],[],"['experiential avoidance, rumination, self-efficacy, and self-discrepancy']","[{'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C4505427', 'cui_str': 'Psychological Processes'}]",[],"[{'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}]",148.0,0.0796495,"The MBI significantly reduced symptomatology, and this effect was mediated by regulatory and belief-related dimensions of BA.","[{'ForeName': 'Marbella', 'Initials': 'M', 'LastName': 'Pérez-Peña', 'Affiliation': 'Human Sciences Sector, Faculty of Psychology and Educational Sciences, School of Psychology, University of Louvain, 1348 Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Notermans', 'Affiliation': 'Human Sciences Sector, Faculty of Psychology and Educational Sciences, School of Psychology, University of Louvain, 1348 Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Desmedt', 'Affiliation': 'Human Sciences Sector, Faculty of Psychology and Educational Sciences, School of Psychology, University of Louvain, 1348 Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Van der Gucht', 'Affiliation': 'Leuven Mindfulness Centre, Humanities and Social Sciences Group, Faculty of Psychology and Educational Sciences, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Philippot', 'Affiliation': 'Human Sciences Sector, Faculty of Psychology and Educational Sciences, School of Psychology, University of Louvain, 1348 Louvain-la-Neuve, Belgium.'}]",Brain sciences,['10.3390/brainsci12020285']
2264,35203976,A Performance-Based Teleintervention for Adults in the Chronic Stage after Acquired Brain Injury: An Exploratory Pilot Randomized Controlled Crossover Study.,"This pilot study aimed to investigate the initial effect of a remotely delivered performance-based client-centered intervention on activity performance and participation among adults in the chronic phase after acquired brain injury (ABI). Sixteen participants living at home with little to no assistance in basic daily activities were allocated into intervention or waitlist control groups. Assessments were conducted at the baseline, after the 3-month intervention/wait period, and at a 3-month follow-up. The primary outcomes were activity performance using the Canadian Occupational Performance Measure (COPM) and the Performance Quality Rating Scale (PQRS) and participation using the Mayo-Portland Adaptability Inventory-4 (MPAI-4). The intervention included weekly videoconferencing sessions using the Cognitive Orientation to Daily Occupational Performance approach (tele-CO-OP). The participants identified five functional goals, of which three were directly addressed. Wilcoxon signed-ranks test results showed no significant improvements in the control group at the end of the 3-month wait period. Pooled data from both groups showed significant improvements in COPM scores for trained and untrained goals following the intervention. Significant improvements were also found in the PQRS and MPAI-4 scores. Improvements were partially maintained at follow-up. Our preliminary results suggest that tele-CO-OP may positively impact the lives of adults after ABI who are coping with long-term disability.",2022,Wilcoxon signed-ranks test results showed no significant improvements in the control group at the end of the 3-month wait period.,"['Sixteen participants living at home with little to no assistance in basic daily activities', 'adults in the chronic phase after acquired brain injury (ABI', 'Adults in the Chronic Stage after Acquired Brain Injury']","['videoconferencing sessions using the Cognitive Orientation to Daily Occupational Performance approach (tele-CO-OP', 'remotely delivered performance-based client-centered intervention']","['COPM scores', 'PQRS and MPAI-4 scores', 'activity performance using the Canadian Occupational Performance Measure (COPM) and the Performance Quality Rating Scale (PQRS) and participation using the Mayo-Portland Adaptability Inventory-4 (MPAI-4']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2733180', 'cui_str': 'Canadian occupational performance measure score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}]",16.0,0.0342039,Wilcoxon signed-ranks test results showed no significant improvements in the control group at the end of the 3-month wait period.,"[{'ForeName': 'Aviva', 'Initials': 'A', 'LastName': 'Beit Yosef', 'Affiliation': 'School of Occupational Therapy, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem 9124001, Israel.'}, {'ForeName': 'Jeremy Michael', 'Initials': 'JM', 'LastName': 'Jacobs', 'Affiliation': 'Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem 9124001, Israel.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Shames', 'Affiliation': 'Medical and Health Professions Division, Maccabi Health Services, Tel Aviv 6812509, Israel.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Schwartz', 'Affiliation': 'Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem 9124001, Israel.'}, {'ForeName': 'Yafit', 'Initials': 'Y', 'LastName': 'Gilboa', 'Affiliation': 'School of Occupational Therapy, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem 9124001, Israel.'}]",Brain sciences,['10.3390/brainsci12020213']
2265,35203965,Personalization of Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Subjective Tinnitus.,"BACKGROUND


Personalization of repetitive transcranial magnetic stimulation (rTMS) for tinnitus might be capable to overcome the heterogeneity of treatment responses. The assessment of loudness changes after short rTMS protocols in test sessions has been proposed as a strategy to identify the best protocol for the daily treatment application. However, the therapeutic advantages of this approach are currently not clear. The present study was designed to further investigate the feasibility and clinical efficacy of personalized rTMS as compared to a standardized rTMS protocol used for tinnitus.
METHODS


RTMS personalization was conducted via test sessions and reliable, sham-superior responses respectively short-term reductions in tinnitus loudness following active rTMS protocols (1, 10, 20 Hz, each 200 pulses) applied over the left and right temporal cortex. Twenty pulses at a frequency of 0.1 Hz served as a control condition (sham). In case of a response, patients were randomly allocated to ten treatment sessions of either personalized rTMS (2000 pulses with the site and frequency producing the most pronounced loudness reduction during test sessions) or standard rTMS (1 Hz, 2000 pulses left temporal cortex). Those participants who did not show a response during the test sessions received the standard protocol as well.
RESULTS


The study was terminated prematurely after 22 patients (instead of 50 planned) as the number of test session responders was much lower than expected (27% instead of 50%). Statistical evaluation of changes in metric tinnitus variables and treatment responses indicated only numerical, but not statistical superiority for personalized rTMS compared to standard treatment.
CONCLUSIONS


The current stage of investigation does not allow for a clear conclusion about the therapeutic advantages of personalized rTMS for tinnitus based on test session responses. The feasibility of this approach is primarily limited by the low test session response rate.",2022,"Statistical evaluation of changes in metric tinnitus variables and treatment responses indicated only numerical, but not statistical superiority for personalized rTMS compared to standard treatment.
",['Chronic Subjective Tinnitus'],"['Repetitive Transcranial Magnetic Stimulation', 'repetitive transcranial magnetic stimulation (rTMS', 'active rTMS protocols', 'standard rTMS', 'personalized rTMS']","['number of test session responders', 'tinnitus loudness']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0155533', 'cui_str': 'Subjective tinnitus'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}]",,0.0129224,"Statistical evaluation of changes in metric tinnitus variables and treatment responses indicated only numerical, but not statistical superiority for personalized rTMS compared to standard treatment.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schoisswohl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, 93053 Regensburg, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Langguth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, 93053 Regensburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hebel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, 93053 Regensburg, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Vielsmeier', 'Affiliation': 'Department of Otorhinolaryngology, University of Regensburg, 93053 Regensburg, Germany.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Abdelnaim', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, 93053 Regensburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schecklmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, 93053 Regensburg, Germany.'}]",Brain sciences,['10.3390/brainsci12020203']
2266,35203964,Decision Making and Risk Propensity in Individuals with Tendencies towards Specific Internet-Use Disorders.,"The uncontrolled use of specific Internet applications is increasingly recognized as a mental health issue. Gaming disorder, which is one subtype of specific Internet-use disorders (sIUDs), has been included in the ICD-11 as disorder due to addictive behaviors. Addictive disorders are assumed to be accompanied by cognitive deficits as indicated by weaker performance in executive function and risky decision-making tasks. This study investigates risky decision-making in individuals with tendencies towards sIUDs including gaming, online buying-shopping, and social-networks-use disorders. A total of 293 individuals participated in the study. Based on specific screening instruments, the participants were assigned to a group with tendencies towards sIUD or a control group. Participants completed a risky decision-making task and questionnaires assessing risk-taking propensity, impulsivity, psychopathology, and perceived stress. The group with sIUD tendencies showed higher attentional impulsivity and higher levels of depression and anxiety compared to the control group. The groups did not differ in decision making and risk propensity. Decision making did not have significant effects on sIUD symptoms. Risk for developing sIUDs does not appear to be accompanied by altered general decision-making tendencies. Rather, psychological (pre-)load and attentional deficits appear to be relevant features in uncontrolled use of the Internet.",2022,The group with sIUD tendencies showed higher attentional impulsivity and higher levels of depression and anxiety compared to the control group.,"['Individuals with Tendencies towards Specific Internet-Use Disorders', '293 individuals participated in the study', 'individuals with tendencies towards sIUDs including gaming, online buying-shopping, and social-networks-use disorders']",[],"['risky decision-making task and questionnaires assessing risk-taking propensity, impulsivity, psychopathology, and perceived stress', 'attentional impulsivity', 'depression and anxiety', 'sIUD symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",[],"[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",293.0,0.0323687,The group with sIUD tendencies showed higher attentional impulsivity and higher levels of depression and anxiety compared to the control group.,"[{'ForeName': 'Silke M', 'Initials': 'SM', 'LastName': 'Müller', 'Affiliation': 'General Psychology, Cognition and Center for Behavioral Addiction Research (CeBAR), University of Duisburg-Essen, 47057 Duisburg, Germany.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Wegmann', 'Affiliation': 'General Psychology, Cognition and Center for Behavioral Addiction Research (CeBAR), University of Duisburg-Essen, 47057 Duisburg, Germany.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Garcia Arías', 'Affiliation': 'Faculty of Education and Psychology, Universidad Francisco de Vitoria, 28223 Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bernabéu Brotóns', 'Affiliation': 'Faculty of Education and Psychology, Universidad Francisco de Vitoria, 28223 Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Marchena Giráldez', 'Affiliation': 'Faculty of Education and Psychology, Universidad Francisco de Vitoria, 28223 Madrid, Spain.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Brand', 'Affiliation': 'General Psychology, Cognition and Center for Behavioral Addiction Research (CeBAR), University of Duisburg-Essen, 47057 Duisburg, Germany.'}]",Brain sciences,['10.3390/brainsci12020201']
2267,35205063,"Effects of 8 Weeks of High-Intensity Interval Training and Spirulina Supplementation on Immunoglobin Levels, Cardio-Respiratory Fitness, and Body Composition of Overweight and Obese Women.","Our study examined the effect of 8 weeks of high-intensity interval training (HIIT) and spirulina supplementation on the humoral immunity, cardio-respiratory fitness, and body composition of overweight and obese women. Thirty sedentary women (height: 161.7 ± 2.8 cm, body mass: 75.8 ± 8.4 kg, body mass index [BMI]: 28.8 ± 2.5 kg/m 2 , age: 25.1 ± 6.7 years) were divided into three groups: placebo with HIIT group, spirulina group (SG), or combined group (CG). Exercise groups performed HIIT for 8 weeks, with three sessions per week and four to seven repetitions in each session of 30 s running and 30 s walking; the intensity was established at 90% of the maximum heart rate. Supplementation groups received 6 g of spirulina powder per day. Fasting blood samples were collected before and after 8 weeks to determine the concentrations of immunoglobulins (IgA and IgG). There was a significant group-by-time interaction for fat free mass (FFM;  p  = 0.001, f = 8.52, ηp 2  = 0.39) and IgA ( p  = 0.036, f = 3.86, ηp 2  = 0.22). The post hoc analysis revealed that CG reduced FFM significantly ( p  = 0.012,  g  = -0.55) after training. CG and SG showed significantly greater IgA concentrations after 8 weeks ( p  = 0.02,  g  = 0.70 and  p  = 0.001,  g  = 0.34, respectively). We conclude that spirulina supplementation with HIIT affects the body composition (lower FFM) but also boosts IgA, which plays an important role in the immune system.",2022,"CG and SG showed significantly greater IgA concentrations after 8 weeks ( p  = 0.02,  g  = 0.70 and  p  = 0.001,  g  = 0.34, respectively).","['Overweight and Obese Women', 'Thirty sedentary women (height: 161.7 ± 2.8 cm, body mass: 75.8 ± 8.4 kg, body mass index [BMI]: 28.8 ± 2.5 kg/m 2 , age: 25.1 ± 6.7 years', 'overweight and obese women']","['High-Intensity Interval Training and Spirulina Supplementation', 'placebo with HIIT group, spirulina group (SG), or combined group (CG', 'high-intensity interval training (HIIT) and spirulina supplementation']","['CG reduced FFM', 'concentrations of immunoglobulins (IgA and IgG', 'humoral immunity, cardio-respiratory fitness, and body composition', 'Fasting blood samples', 'Immunoglobin Levels, Cardio-Respiratory Fitness, and Body Composition', 'IgA concentrations']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0075026', 'cui_str': 'Spirulina'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",30.0,0.0252563,"CG and SG showed significantly greater IgA concentrations after 8 weeks ( p  = 0.02,  g  = 0.70 and  p  = 0.001,  g  = 0.34, respectively).","[{'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Nobari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Educational Sciences and Psychology, University of Mohaghegh Ardabili, Ardabil 56199-11367, Iran.'}, {'ForeName': 'Elham Eyni', 'Initials': 'EE', 'LastName': 'Gandomani', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Isfahan 81746-7344, Iran.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Reisi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Isfahan 81746-7344, Iran.'}, {'ForeName': 'Reyhaneh', 'Initials': 'R', 'LastName': 'Vahabidelshad', 'Affiliation': 'Faculty of Motor Sciences, Université Libre de Bruxelles, 1070 Brussels, Belgium.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Saitama 359-1192, Japan.'}, {'ForeName': 'Stella Lucia', 'Initials': 'SL', 'LastName': 'Volpe', 'Affiliation': 'Department of Human Nutrition, Foods and Exercise, Virginia Polytechnic Institute and State University, Blacksburg, VA 24061, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Pérez-Gómez', 'Affiliation': 'HEME Research Group, Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}]",Biology,['10.3390/biology11020196']
2268,35205008,Foam Splint versus Spica Cast-Early Mobilization after Hip Reconstructive Surgery in Children-Preliminary Data from a Prospective Randomized Clinical Trial.,"BACKGROUND


Surgical hip joint reconstruction may be the method of choice for children and adolescents with developmental dysplasia of the hip (DDH), as well as neurogenic dislocation of the hip (NDH) and Legg-Calvé-Perthes disease (LCPD). Following pelvic surgery, immobilization using a spica cast is considered to be the gold standard, despite the fact that casting may cause complications, such as hygienic problems, skin lesions, neurological deficits, and rigidity of the adjacent joints. An alternative for postoperative immobilization is a foam splint. The purpose of this randomized controlled trial was to compare spica cast and foam splint immobilization after hip reconstruction in children and adolescents with DDH, NDH, and LCPD.
METHODS


In a prospective randomized clinical trial, children and adolescents (age: 4-14 years), who received hip reconstructive surgery (osteotomy of the ilium and proximal femur, open reduction, soft tissue techniques) for DDH, NDH, and LCPD were included. Patient recruitment, group allocation, surgery, and aftercare were carried out in a department for orthopaedic surgery in Central Europe. Standardized questionnaires SF-36 (Short Form-36), EQ-5D (Euro Quality of Life 5D and CPCHILD (Caregiver Priorities and Child Health Index of Life with Disabilities) were gathered before, six, and twelve weeks after surgery from each patient. Group one received a spica cast and group two a foam splint for a period of six weeks postoperatively. There was no difference in surgical treatment.
RESULTS


Twenty-one out of thirty planned patients were enrolled in the study. One patient had to be excluded because of a lack of compliance. All quality of life (QOL) scores showed a significant reduction at the 6-week follow-up compared to the preoperative assessment. After twelve weeks, the scores came back close to the preoperative values. A significant reduction was seen in the spica cast group pre- vs. postoperatively for the variables CPCHILD (81% vs. 64%,  p  = 0.001), EQ-5d (65% vs. 45%,  p  = 0.014), and SF-36 (85% vs. 74%,  p  = 0.004). The corresponding values for the foam splint group also presented a reduction for all scores, but without statistical significance. Complications occurred in five cases.
CONCLUSIONS


Recent retrospective studies suggest that foam splint immobilization after hip reconstruction surgery is a safe and feasible method, promising fewer complications compared to spica casting. The preliminary results of this prospective randomized clinical trial show an improvement of the scores when using a foam splint compared to the conventionally used spica cast. Benefits for the patients may be fewer adverse events and no need to undergo a second round of anaesthesia for recasting. Data suggest higher patient and caretaker satisfaction in the foam splint group.",2022,"p  = 0.001), EQ-5d (65% vs. 45%,  p  = 0.014), and SF-36 (85% vs. 74%,  p  = 0.004).","['Twenty-one', 'children and adolescents (age: 4-14 years), who received hip reconstructive surgery (osteotomy of the ilium and proximal femur, open reduction, soft tissue techniques) for DDH, NDH, and LCPD were included', 'children and adolescents with DDH, NDH, and LCPD', 'thirty planned patients were enrolled in the study', 'children and adolescents with developmental dysplasia of the hip (DDH']","['spica cast and group two a foam splint', 'Foam Splint versus Spica Cast-Early Mobilization after Hip Reconstructive Surgery', 'spica cast and foam splint immobilization']","['All quality of life (QOL) scores', 'EQ-5d', 'Standardized questionnaires SF-36 (Short Form-36), EQ-5D (Euro Quality of Life 5D and CPCHILD (Caregiver Priorities and Child Health Index of Life with Disabilities', 'SF-36', 'Complications', 'adverse events', 'surgical treatment', 'caretaker satisfaction']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0020889', 'cui_str': 'Bone structure of ilium'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4551649', 'cui_str': 'Congenital hip dysplasia'}, {'cui': 'C0019554', 'cui_str': 'Dislocation of hip joint'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1289821', 'cui_str': 'Spica cast'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0335350', 'cui_str': 'Building caretaker'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0619374,"p  = 0.001), EQ-5d (65% vs. 45%,  p  = 0.014), and SF-36 (85% vs. 74%,  p  = 0.004).","[{'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Pisecky', 'Affiliation': 'Department for Orthopaedics and Traumatology, Johannes Kepler University Linz, Kepler University Hospital GmbH, Altenberger Strasse 96, 4040 Linz and Krankenhausstraße 9, 4020 Linz, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Großbötzl', 'Affiliation': 'Department for Orthopaedics and Traumatology, Johannes Kepler University Linz, Kepler University Hospital GmbH, Altenberger Strasse 96, 4040 Linz and Krankenhausstraße 9, 4020 Linz, Austria.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Gahleitner', 'Affiliation': 'Department for Orthopaedics and Traumatology, Johannes Kepler University Linz, Kepler University Hospital GmbH, Altenberger Strasse 96, 4040 Linz and Krankenhausstraße 9, 4020 Linz, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stadler', 'Affiliation': 'Department for Orthopaedics and Traumatology, Johannes Kepler University Linz, Kepler University Hospital GmbH, Altenberger Strasse 96, 4040 Linz and Krankenhausstraße 9, 4020 Linz, Austria.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Stevoska', 'Affiliation': 'Department for Orthopaedics and Traumatology, Johannes Kepler University Linz, Kepler University Hospital GmbH, Altenberger Strasse 96, 4040 Linz and Krankenhausstraße 9, 4020 Linz, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Haas', 'Affiliation': 'Department for Orthopaedics and Traumatology, Johannes Kepler University Linz, Kepler University Hospital GmbH, Altenberger Strasse 96, 4040 Linz and Krankenhausstraße 9, 4020 Linz, Austria.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Gotterbarm', 'Affiliation': 'Department for Orthopaedics and Traumatology, Johannes Kepler University Linz, Kepler University Hospital GmbH, Altenberger Strasse 96, 4040 Linz and Krankenhausstraße 9, 4020 Linz, Austria.'}, {'ForeName': 'Matthias Christoph Michael', 'Initials': 'MCM', 'LastName': 'Klotz', 'Affiliation': 'Department for Orthopaedics and Traumatology, Marienkrankenhaus Soest GmbH, Widumgasse 5, 59494 Soest, Germany.'}]","Children (Basel, Switzerland)",['10.3390/children9020288']
2269,35205004,Effects of Family Nurture Intervention in the NICU on Theory of Mind Abilities in Children Born Very Preterm: A Randomized Controlled Trial.,"Preterm infants are at risk for socioemotional deficits, neurodevelopmental disorders, and potentially theory of mind (ToM) deficits. Preterm infants enrolled in a randomized controlled trial in the neonatal intensive care unit (NICU) received Standard Care (SC) or Family Nurture Intervention (FNI). Children (N = 72; median age 61.8 ± 2.6 months; FNI: 35 (55%), SC:2 9 (45%)) completed a ToM task, of whom 64 (54% male; born to White (43.8%), Black (18.7%), and Hispanic (25.0%) mothers) contributed to this analysis. FNI and SC infants born extremely preterm to very preterm differed significantly: 78% (14 of 18) of FNI children passed vs. 30% (3 of 10) SC children ( p  = 0.01, effect size = 1.06). This large effect size suggests that FNI in the NICU may ameliorate deficits in social-cognitive skills of extreme to very preterm infants by school age.",2022,"FNI and SC infants born extremely preterm to very preterm differed significantly: 78% (14 of 18) of FNI children passed vs. 30% (3 of 10) SC children ( p  = 0.01, effect size = 1.06).","['Children (N = 72; median age 61.8 ± 2.6 months; FNI: 35 (55%), SC:2 9 (45%)) completed a ToM task, of whom 64 (54% male; born to White (43.8%), Black (18.7%), and Hispanic (25.0%) mothers', 'Children Born', 'Preterm infants enrolled', 'Very Preterm', 'Preterm infants']","['Family Nurture Intervention', 'neonatal intensive care unit (NICU) received Standard Care (SC) or Family Nurture Intervention (FNI']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],,0.127563,"FNI and SC infants born extremely preterm to very preterm differed significantly: 78% (14 of 18) of FNI children passed vs. 30% (3 of 10) SC children ( p  = 0.01, effect size = 1.06).","[{'ForeName': 'Morgan R', 'Initials': 'MR', 'LastName': 'Firestein', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY 10032, USA.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Myers', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY 10032, USA.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Feder', 'Affiliation': 'Yale University School of Medicine, New Haven, CT 06510, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Ludwig', 'Affiliation': 'Department of Pediatrics, Columbia University Irving Medical Center, New York, NY 10032, USA.'}, {'ForeName': 'Martha G', 'Initials': 'MG', 'LastName': 'Welch', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY 10032, USA.'}]","Children (Basel, Switzerland)",['10.3390/children9020284']
2270,35204863,Post-Discharge Effects and Parents' Opinions of Intranasal Fentanyl with Oral Midazolam Sedation in Pediatric Dental Patients: A Cross-Sectional Study.,"The aim of this study was to evaluate the post-discharge effects of oral midazolam with intranasal fentanyl sedation in pediatric patients who had dental treatment and to evaluate parents' preference regarding sedation visits.
METHODS


A total of 32 uncooperative healthy pediatric patients aged 3-6 years old who met the inclusion criteria were included. In the first visit, one group received oral midazolam (0.7 mg/kg) with intranasal fentanyl (1 μg/kg) sedation (M/F) and the other group received oral midazolam with intranasal placebo (M), and in the second visit each group received the other type of sedation in a cross-over type. In this cross-sectional study, a post-discharge phone-call questionnaire was carried out 24 h after both sedation visits with the parents to evaluate the children's behavior, function, balance, eating pattern, sleeping pattern, vomiting incidents, and any possible side effects, as well as parents' satisfaction and preference. The Wilcoxon signed-rank test was used to analyze the categorical variables, and the Chi-square test was performed to analyze the parents' preference.
RESULT


A total of 32 parents responded to the phone-call questionnaire after 64 sedation visits. All of them were mothers. There was no statistically significant difference between the two groups with respect to recovery to normal function and balance, behavior, incidents of fever, vomiting, sleep disturbance, oversleeping, and adverse behavioral changes ( p  > 0.05). Children required a significantly longer amount of time until the first meal after M/F sedation ( p  = 0.04). No significant difference was found between parents' preferences regarding the sedation visits ( p  > 0.05).
CONCLUSION


Intranasal fentanyl added to oral midazolam sedation could have an effect on post-discharge adverse behavioral changes, prolonged sleeping, and prolonged recovery time. Children sedated with midazolam/fentanyl required a longer amount of time until the first meal. Vomiting and fever occurred similarly in both sedation regimens with a low incidence. There was no difference in parents' preferences regarding the two sedation regimens.",2022,"There was no statistically significant difference between the two groups with respect to recovery to normal function and balance, behavior, incidents of fever, vomiting, sleep disturbance, oversleeping, and adverse behavioral changes ( p  > 0.05).","['Pediatric Dental Patients', ""pediatric patients who had dental treatment and to evaluate parents' preference regarding sedation visits"", '32 uncooperative healthy pediatric patients aged 3-6 years old who met the inclusion criteria were included', '32 parents responded to the phone-call questionnaire after 64 sedation visits']","['Intranasal Fentanyl with Oral Midazolam Sedation', 'intranasal fentanyl', 'oral midazolam', 'intranasal fentanyl sedation', 'midazolam/fentanyl', 'oral midazolam with intranasal placebo (M', 'midazolam', 'Intranasal fentanyl', 'midazolam sedation']","['longer amount of time until the first meal after M/F sedation', 'longer amount of time until the first meal', 'normal function and balance, behavior, incidents of fever, vomiting, sleep disturbance, oversleeping, and adverse behavioral changes', 'post-discharge adverse behavioral changes, prolonged sleeping, and prolonged recovery time', ""parents' preferences regarding the sedation visits"", ""children's behavior, function, balance, eating pattern, sleeping pattern, vomiting incidents"", 'Vomiting and fever']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0424350', 'cui_str': 'Uncooperative behavior'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0424572', 'cui_str': 'Oversleeps'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",32.0,0.0181098,"There was no statistically significant difference between the two groups with respect to recovery to normal function and balance, behavior, incidents of fever, vomiting, sleep disturbance, oversleeping, and adverse behavioral changes ( p  > 0.05).","[{'ForeName': 'Roaa I', 'Initials': 'RI', 'LastName': 'Alhaidari', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Maha A', 'Initials': 'MA', 'LastName': 'AlSarheed', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}]","Children (Basel, Switzerland)",['10.3390/children9020142']
2271,35204861,Maternal Singing but Not Speech Enhances Vagal Activity in Preterm Infants during Hospitalization: Preliminary Results.,"BACKGROUND


Early parental interventions in the Neonatal Intensive Care Units (NICUs) have beneficial effects on preterm infants' short and long-term outcomes. The aim of this study was to investigate the effects of Early Vocal Contact (EVC)-singing and speaking-on preterm infants' vagal activity and autonomic nervous system (ANS) maturation.
METHODS


In this multi-center randomized clinical trial, twenty-four stable preterm infants, born at 25-32 weeks gestational age, were randomized to either the EVC group or control group, where mothers did not interact with the babies but observed their behavior. Heart Rate Variability (HRV) was acquired before intervention (pre-condition), during vocal contact, and after it (post condition).
RESULTS


No significant effect of the vocal contact, singing and speaking, was found in HRV when the intervention group was compared to the control group. However, a significant difference between the singing and the pre and post conditions, respectively, preceding and following the singing intervention, was found in the Low and High Frequency power nu, and in the low/high frequency features ( p  = 0.037). By contrast, no significant effect of the speaking was found.
CONCLUSIONS


Maternal singing, but not speaking, enhances preterm infants' vagal activity in the short-term, thus improving the ANS stability. Future analyses will investigate the effect of enhanced vagal activity on short and long-term developmental outcomes of preterm infants in the NICU.",2022,"No significant effect of the vocal contact, singing and speaking, was found in HRV when the intervention group was compared to the control group.","['twenty-four stable preterm infants, born at 25-32 weeks gestational age', 'Preterm Infants during Hospitalization', 'preterm infants in the NICU']","['Early Vocal Contact (EVC)-singing and speaking', 'EVC', 'Maternal Singing but Not Speech']","['Vagal Activity', 'Heart Rate Variability (HRV', 'HRV', 'vocal contact, singing and speaking', ""preterm infants' vagal activity""]","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]",24.0,0.0247657,"No significant effect of the vocal contact, singing and speaking, was found in HRV when the intervention group was compared to the control group.","[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Filippa', 'Affiliation': 'Department of Psychology and Educational Sciences, University of Geneva, 24 Rue General Dufour, 1211 Geneva, Switzerland.'}, {'ForeName': 'Mimma', 'Initials': 'M', 'LastName': 'Nardelli', 'Affiliation': 'Bioengineering and Robotics Research Centre E. Piaggio, 56122 Pisa, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Della Casa', 'Affiliation': ""Neonatal Intensive Care Unit, Women's and Children's Health Department, University Hospital of Modena, 41124 Modena, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Berardi', 'Affiliation': 'Department of Medical and Surgical Sciences of Mother, Children and Adults, University Hospital of Modena, 41124 Modena, Italy.'}, {'ForeName': 'Odoardo', 'Initials': 'O', 'LastName': 'Picciolini', 'Affiliation': ""Pediatric Physical Medicine & Rehabilitation Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122 Milan, Italy.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Meloni', 'Affiliation': ""Pediatric Physical Medicine & Rehabilitation Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122 Milan, Italy.""}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Lunardi', 'Affiliation': 'Department of Neurosciences, Psychology, Drug Research and Child Health, Careggi University Hospital of Florence, 50139 Florence, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Cecchi', 'Affiliation': 'Division of Neonatology, Careggi University Hospital, School of Medicine, University of Florence, 50134 Florence, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Sansavini', 'Affiliation': 'Department of Psychology ""Renzo Canestrari"", University of Bologna, Viale Berti Pichat 5, 40127 Bologna, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Corvaglia', 'Affiliation': 'Neonatal Intensive Care Unit, IRCCS AOU Bologna, Via Massarenti 9, 40138 Bologna, Italy.'}, {'ForeName': 'Enzo Pasquale', 'Initials': 'EP', 'LastName': 'Scilingo', 'Affiliation': 'Bioengineering and Robotics Research Centre E. Piaggio, 56122 Pisa, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Ferrari', 'Affiliation': 'Department of Medical and Surgical Sciences of Mother, Children and Adults, University Hospital of Modena, 41124 Modena, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Evc Group', 'Affiliation': ''}]","Children (Basel, Switzerland)",['10.3390/children9020140']
2272,35205205,Acute Changes in Heart Rate Variability to Glucose and Fructose Supplementation in Healthy Individuals: A Double-Blind Randomized Crossover Placebo-Controlled Trial.,"BACKGROUND


It is unknown how different types of carbohydrates alter the cardio-autonomic system in healthy individuals. Therefore, the aim of this study was to investigate how heart-rate variability changes to single dose ingestion of glucose, fructose, glucose and fructose, and an artificial sweetener (sucralose).
METHODS


In a double-blind randomized crossover placebo-controlled setting, 15 participants received all study-specific substances in liquid form. During each 2-h visit, venous blood glucose was measured in a 5-min interval while heart-rate variability was measured continuously via Holter-electrocardiograph.
RESULTS


Ingestion of different types of carbohydrates and sucralose showed significant differences for heart rate ( p  < 0.001), SDNN ( p  < 0.008), RMSSD ( p  < 0.001), pNN50 ( p  < 0.001) and blood pressure ( p  < 0.001). Different glucose levels significantly altered parameters of heart-rate variability and blood pressure (all  p  < 0.001), while the rate of change in blood glucose led to changes in heart rate variability, but not in heart rate ( p  = 0.25) or blood pressure ( p  = 0.99).
CONCLUSIONS


Ingestion of different types of carbohydrates lead to reductions in heart-rate variability compared to a placebo. Blood glucose values above or below 70-90 mg/dL decreased heart rate variability while this was also seen for rapid glucose changes, yet not as pronounced. Healthy individuals should be conscious about carbohydrate intake while maintaining blood glucose levels between 70-90 mg/dL.",2022,"Different glucose levels significantly altered parameters of heart-rate variability and blood pressure (all  p  < 0.001), while the rate of change in blood glucose led to changes in heart rate variability, but not in heart rate ( p  = 0.25) or blood pressure ( p  = 0.99).
","['healthy individuals', 'Healthy Individuals', 'Healthy individuals', '15 participants received all study-specific substances in liquid form']","['placebo', 'Placebo', 'glucose, fructose, glucose and fructose, and an artificial sweetener (sucralose', 'Glucose and Fructose Supplementation']","['heart-rate variability and blood pressure', 'heart rate variability', 'heart rate', 'blood glucose levels', 'rate of change in blood glucose', 'venous blood glucose', 'heart-rate variability', 'RMSSD', 'blood pressure', 'Blood glucose values']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0003920', 'cui_str': 'Artificial sweetener'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.314394,"Different glucose levels significantly altered parameters of heart-rate variability and blood pressure (all  p  < 0.001), while the rate of change in blood glucose led to changes in heart rate variability, but not in heart rate ( p  = 0.25) or blood pressure ( p  = 0.99).
","[{'ForeName': 'Max Lennart', 'Initials': 'ML', 'LastName': 'Eckstein', 'Affiliation': 'Division of Exercise Physiology and Metabolism, Department of Sport Science, University of Bayreuth, 95440 Bayreuth, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Brockfeld', 'Affiliation': 'Division of Exercise Physiology and Metabolism, Department of Sport Science, University of Bayreuth, 95440 Bayreuth, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Haupt', 'Affiliation': 'Division of Exercise Physiology and Metabolism, Department of Sport Science, University of Bayreuth, 95440 Bayreuth, Germany.'}, {'ForeName': 'Janis Ramon', 'Initials': 'JR', 'LastName': 'Schierbauer', 'Affiliation': 'Division of Exercise Physiology and Metabolism, Department of Sport Science, University of Bayreuth, 95440 Bayreuth, Germany.'}, {'ForeName': 'Rebecca Tanja', 'Initials': 'RT', 'LastName': 'Zimmer', 'Affiliation': 'Division of Exercise Physiology and Metabolism, Department of Sport Science, University of Bayreuth, 95440 Bayreuth, Germany.'}, {'ForeName': 'Nadine Bianca', 'Initials': 'NB', 'LastName': 'Wachsmuth', 'Affiliation': 'Division of Exercise Physiology and Metabolism, Department of Sport Science, University of Bayreuth, 95440 Bayreuth, Germany.'}, {'ForeName': 'Beate Elisabeth Maria', 'Initials': 'BEM', 'LastName': 'Zunner', 'Affiliation': 'Division of Exercise Physiology and Metabolism, Department of Sport Science, University of Bayreuth, 95440 Bayreuth, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Zimmermann', 'Affiliation': 'Division of Exercise Physiology and Metabolism, Department of Sport Science, University of Bayreuth, 95440 Bayreuth, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Erlmann', 'Affiliation': 'Division of Exercise Physiology and Metabolism, Department of Sport Science, University of Bayreuth, 95440 Bayreuth, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Obermayer-Pietsch', 'Affiliation': 'Endocrinology Lab Platform, Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Aberer', 'Affiliation': 'Division of Exercise Physiology and Metabolism, Department of Sport Science, University of Bayreuth, 95440 Bayreuth, Germany.'}, {'ForeName': 'Othmar', 'Initials': 'O', 'LastName': 'Moser', 'Affiliation': 'Division of Exercise Physiology and Metabolism, Department of Sport Science, University of Bayreuth, 95440 Bayreuth, Germany.'}]",Biology,['10.3390/biology11020338']
2273,35193046,Self-administered acupressure for insomnia disorder: A randomized controlled trial.,"BACKGROUND


Insomnia is a significant health problem in the community. Self-administered acupressure (SAA) may be an alternative strategy to alleviate insomnia.
PURPOSE


This study is the first to investigate the effects of SAA delivered through a training course in alleviating insomnia disorder compared with sleep hygiene education (SHE).
METHODS


A randomized controlled trial was conducted on 200 participants with insomnia disorder. The eligible participants were randomized into the SAA or SHE group. Both groups attended the allocated training courses (two sessions, 2 h each) and then were followed up at weeks 4 and 8. The primary outcome was the severity of insomnia symptoms and related daytime impairment as measured by the Insomnia Severity Index (ISI). Other measures included a 7-day sleep diary and actigraphy, Hospital Anxiety and Depression Scale (HADS), and Short-Form Six-Dimension (SF6D).
RESULTS


The SAA group showed a significantly greater improvement in ISI score than the SHE group at week 4 (mean difference: -1.89 units, 95% CI: 0.85, 2.93; Cohen's d = 0.51, p < 0.001) and week 8 (mean difference: -2.89 units, 95% CI: 1.67, 4.11; d = 0.67, p < 0.001). In addition, the SAA group showed a greater reduction in the HADS anxiety score and HADS depression score and increase in SF6D at week 8.
CONCLUSIONS


SAA taught in a short training course is a feasible and effective approach to improve sleep and related daytime impairment and mood problems in individuals with insomnia disorder.",2022,"The SAA group showed a significantly greater improvement in ISI score than the SHE group at week 4 (mean difference: -1.89 units, 95% CI: 0.85, 2.93; Cohen's d = 0.51, p < 0.001) and week 8 (mean difference: -2.89 units, 95% CI: 1.67, 4.11; d = 0.67, p < 0.001).","['individuals with insomnia disorder', 'insomnia disorder', '200 participants with insomnia disorder']","['sleep hygiene education (SHE', 'SAA or SHE', 'SAA', 'Self-administered acupressure', 'Self-administered acupressure (SAA']","['HADS anxiety score and HADS depression score and increase in SF6D', 'ISI score', 'severity of insomnia symptoms and related daytime impairment as measured by the Insomnia Severity Index (ISI', '7-day sleep diary and actigraphy, Hospital Anxiety and Depression Scale (HADS), and Short-Form Six-Dimension (SF6D']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",200.0,0.168367,"The SAA group showed a significantly greater improvement in ISI score than the SHE group at week 4 (mean difference: -1.89 units, 95% CI: 0.85, 2.93; Cohen's d = 0.51, p < 0.001) and week 8 (mean difference: -2.89 units, 95% CI: 1.67, 4.11; d = 0.67, p < 0.001).","[{'ForeName': 'Wing Fai', 'Initials': 'WF', 'LastName': 'Yeung', 'Affiliation': 'School of Nursing, the Hong Kong Polytechnic University, HKSAR, China; Research Centre for Chinese Medicine Innovation, the Hong Kong Polytechnic University, HKSAR, China. Electronic address: jerry-wf.yeung@polyu.edu.hk.'}, {'ForeName': 'Branda Yee-Man', 'Initials': 'BY', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, the University of Hong Kong, HKSAR, China.'}, {'ForeName': 'Ka-Fai', 'Initials': 'KF', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry, the University of Hong Kong, HKSAR, China.'}, {'ForeName': 'Zhang-Jin', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, the University of Hong Kong, HKSAR, China.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Lao', 'Affiliation': 'Virginia University of Integrative Medicine, USA.'}, {'ForeName': 'Fiona Yan-Yee', 'Initials': 'FY', 'LastName': 'Ho', 'Affiliation': 'Department of Psychology, the Chinese University of Hong Kong, HKSAR, China.'}, {'ForeName': 'Lorna Kwai-Ping', 'Initials': 'LK', 'LastName': 'Suen', 'Affiliation': 'School of Nursing, Tung Wah College, HKSAR, China.'}, {'ForeName': 'Lai-Ming', 'Initials': 'LM', 'LastName': 'Ho', 'Affiliation': 'School of Public Health, the University of Hong Kong, HKSAR, China.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2022.153993']
2274,35193902,"SPEAKS study: study protocol of a multisite feasibility trial of the Specialist Psychotherapy with Emotion for Anorexia in Kent and Sussex (SPEAKS) intervention for outpatients with anorexia nervosa or otherwise specified feeding and eating disorders, anorexia nervosa type.","INTRODUCTION


Anorexia nervosa (AN) is a severe mental health condition associated with high mortality rates and significantly impaired quality of life. National guidelines outline psychotherapeutic interventions as treatments of choice for adults with AN, but outcomes are limited and therapy drop-out high, resulting in calls for new innovative treatments. The Specialist Psychotherapy with Emotion for Anorexia in Kent and Sussex (SPEAKS) research programme sought to develop the SPEAKS intervention avoiding some difficulties inherent in development of earlier interventions, such unclear hypotheses about change processes. SPEAKS focuses on a core hypothesised maintaining factor (emotional experience) with clear proposed model of change. The current feasibility trial aims to provide an initial test of SPEAKS and inform design of a full randomised controlled trial protocol.
METHODS AND ANALYSIS


This study employs a multisite, single-arm, within-group, mixed-methods design. Up to 60 participants (36 therapy completers) meeting inclusion criteria will be offered the SPEAKS intervention instead of treatment-as-usual (TAU). SPEAKS is a weekly psychotherapy lasting nine to 12 months, provided by trained and experienced eating disorders therapists. All other clinical input remains inline with TAU. Acceptability will be assessed using VAS scales and end of therapy interview. Reach and recruitment, such as recruitment yield, will be monitored. To support sample size estimation and economic estimation, data pertaining to eating disorder-related symptoms will be recorded every 3 months, alongside service usage and intervention-specific measures. Videoed therapy sessions will inform model adherence. Additional analyses coding videoed therapy will test SPEAKS change process hypotheses.
ETHICS AND DISSEMINATION


Ethical approval has been granted by London-Bromley Research Ethics Committee (NHS Rec Reference: 19/LO/1530). Data will be disseminated via high-impact, peer-reviewed journals (Open Access preferred), conferences, service user and charity networks (eg, UK charity BEAT) and through a free open conference hosted by National Health Service Trusts and Higher Education Institutions.
TRIAL REGISTRATION NUMBER


ISRCTN11778891.
TRIAL STATUS


Recruitment began on 12 December 2019 and ends on 28 February 2021. All data will be collected and the trial ended by 28 February 2022.
PROTOCOL VERSION


SPEAKS protocol V.3.0 (30 August 2020). Changes were made to the original protocol due to the COVID-19 pandemic. A further set of changes were made to incorporate the measures of change processes, resulting in this being the third version of the protocol.",2022,Up to 60 participants (36 therapy completers) meeting inclusion criteria will be offered the SPEAKS intervention instead of treatment-as-usual (TAU).,"['Recruitment began on 12 December 2019 and ends on 28 February 2021', '60 participants (36 therapy completers) meeting inclusion criteria will be offered the SPEAKS intervention instead of treatment-as-usual (TAU', 'outpatients with anorexia nervosa or otherwise specified feeding and eating disorders, anorexia nervosa type']",['Specialist Psychotherapy with Emotion for Anorexia in Kent and Sussex (SPEAKS) intervention'],[],"[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0454861', 'cui_str': 'Kent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0454861', 'cui_str': 'Kent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.135723,Up to 60 participants (36 therapy completers) meeting inclusion criteria will be offered the SPEAKS intervention instead of treatment-as-usual (TAU).,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Oldershaw', 'Affiliation': 'Kent and Medway All Age Eating Disorder Service, North East London NHS Foundation Trust, Kent, UK annaoldershaw@hotmail.com.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Lavender', 'Affiliation': 'Salomons Institute for Applied Psychology, Canterbury Christ Church University, Tunbridge Wells, UK.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Basra', 'Affiliation': 'Kent and Medway All Age Eating Disorder Service, North East London NHS Foundation Trust, Kent, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Startup', 'Affiliation': 'Brighton and Hove Eating Disorder Service, Sussex Partnership NHS Foundation Trust, Brighton, UK.'}]",BMJ open,['10.1136/bmjopen-2021-050350']
2275,34889041,Clinical efficacy of different therapeutic modes of CO 2  fractional laser for treatment of static periocular wrinkles in Asian skin.,"BACKGROUND


Periocular fine lines and wrinkles usually appear as a first visible sign of facial aging. Fractional ablative laser has been used to treat periorbital wrinkles.
OBJECTIVE


To compare the efficacy on treatment of static periorbital wrinkles using different emission modes of CO 2  fractional laser.
METHODS


A total of 30 patients with static periorbital wrinkles were enrolled. The subjects were randomly assigned into two split-face groups: One side was treated with a deep (n = 15) or mid-mode of CO 2   superficial laser (n = 15), and the other side of periocular region was treated by a fusion mode in combination of both modes (n = 30).
RESULTS


The patients in three groups showed significant improvements on indexes of periocular wrinkles, skin textures, and elasticity at three-month follow-up as compared with baseline (p < 0.05). Fusion mode resulted in a significantly progressive improvement on periocular wrinkles at three-month follow-up as compared with one-month follow-up (p < 0.05), which were not observed in other modes. Fusion mode delivered better improvements of periocular wrinkles and skin textures as compared to deep and mid-modes at three-month follow-up (p < 0.05). Fusion mode also resulted in better scores of global esthetic improvement scale and patient satisfaction as compared to other modes at both follow-ups.
CONCLUSION


The fusion mode has a synergistic effect in periorbital static wrinkle treatment, which is worthy of further evaluation and investigation.",2022,"Fusion mode resulted in a significantly progressive improvement on periocular wrinkles at three-month follow-up as compared with one-month follow-up (p < 0.05), which were not observed in other modes.","['static periocular wrinkles in Asian skin', '30 patients with static periorbital wrinkles were enrolled']","['CO 2  fractional laser', 'Fractional ablative laser', 'CO 2  \xa0superficial laser']","['indexes of periocular wrinkles, skin textures, and elasticity', 'periocular wrinkles', 'periocular wrinkles and skin textures', 'global esthetic improvement scale and patient satisfaction']","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0230064', 'cui_str': 'Periorbital'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0423752', 'cui_str': 'Finding of skin texture'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",30.0,0.0240651,"Fusion mode resulted in a significantly progressive improvement on periocular wrinkles at three-month follow-up as compared with one-month follow-up (p < 0.05), which were not observed in other modes.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': ""Department of Dermatology, XiJing Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': ""Department of Dermatology, XiJing Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Linhan', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': ""Department of Dermatology, XiJing Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jine', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Dermatology, XiJing Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ""Department of Dermatology, XiJing Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Dermatology, XiJing Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': ""Department of Dermatology, XiJing Hospital, The Fourth Military Medical University, Xi'an, China.""}]",Journal of cosmetic dermatology,['10.1111/jocd.14640']
2276,35196941,Prediction and prevention of preterm birth in pregnant women living with HIV on antiretroviral therapy.,"INTRODUCTION


The rate of spontaneous preterm-birth among pregnant women living with HIV on antiretroviral therapy (ART) is 3- to 4-fold higher when compared to HIV-negative women. The pathophysiology of preterm-birth related to HIV or ART remains unknown, especially as women living with HIV are often excluded from preterm birth studies.
AREAS COVERED


This review discusses the currently available evidence on the prediction and prevention of preterm-birth in pregnant women living with HIV. A review of the literature was conducted of primary articles between 2005 and 2021 measuring the association or lack thereof between combination ART and preterm birth, as well as of other predisposing factors to preterm birth in women living with HIV, including cervical length, vaginal microbiome, and cervico-vaginal biomarkers.
EXPERT OPINION


Further research into the effect of ART exposure on preterm-birth risk is critical, and development of preterm-birth predictive tools in this population should be a priority. Vaginal progesterone supplementation deserves further investigation as a therapeutic option to prevent recurrent preterm birth in pregnant women living with HIV. The ProSPAR study, a multicenter randomized controlled trial studying progesterone supplementation in pregnant women on protease inhibitor-based regimens, has been designed but is not yet recruiting patients.",2022,The rate of spontaneous preterm birth among pregnant women living with HIV on antiretroviral therapy (ART) is 3-4-fold higher when compared to HIV-negative women.,"['pregnant women on protease inhibitor-based regimens', 'pregnant women living with HIV on antiretroviral therapy (ART', 'pregnant women living with HIV on antiretroviral therapy', 'primary articles between 2005 and 2021 measuring the association or lack thereof between combination ART and preterm birth, as well as of other predisposing factors to preterm birth in women living with HIV, including cervical length, vaginal microbiome, and cervico-vaginal biomarkers', 'pregnant women living with HIV']","['progesterone supplementation', 'Vaginal progesterone supplementation']","['rate of spontaneous preterm birth', 'recurrent preterm birth']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0205064', 'cui_str': 'Cervical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",,0.471882,The rate of spontaneous preterm birth among pregnant women living with HIV on antiretroviral therapy (ART) is 3-4-fold higher when compared to HIV-negative women.,"[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Jones', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore.'}, {'ForeName': 'Uzoamaka A', 'Initials': 'UA', 'LastName': 'Eke', 'Affiliation': 'Division of Infectious Diseases and Institute of Human Virology, Department of Internal Medicine, University of Maryland School of Medicine, Baltimore, United States of America.'}, {'ForeName': 'Ahizechukwu C', 'Initials': 'AC', 'LastName': 'Eke', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Gynecology & Obstetrics, Johns Hopkins University School of Medicine, Baltimore.'}]",Expert review of anti-infective therapy,['10.1080/14787210.2022.2046463']
2277,35197538,The effect of video-assisted discharge education after total hip replacement surgery: a randomized controlled study.,"This study aimed to investigate the effect of a video-assisted discharge education program on activities of daily living, functionality, and patient satisfaction following total hip replacement (THR) surgery. This study included 31 patients who were randomly divided into the physiotherapy group (n = 18), and the video-assisted discharge education (VADE) group (n = 13). Both groups received a physiotherapy program. The VADE group was also received the VADE program. Face-to-face instruction was used in all of the educational programs. There was a significant difference in favor of the VADE group in Harris Hip Score, Nottingham Extended Activities of Daily Living Scale's movement score, Tampa Scale of Kinesiophobia, Patient Satisfaction Questionnaire (p < 0.05). There was a significant difference between groups on resting pain levels in the first week and on resting and activity pain levels in the third month in favor of the VADE group (p < 0.05). The results of this study demonstrated that VADE can be effective in improving patient satisfaction and functionality, reducing pain and kinesiophobia following THR.",2022,There was a significant difference between groups on resting pain levels in the first week and on resting and activity pain levels in the third month in favor of the VADE group (p < 0.05).,"['after total hip replacement surgery', '31 patients who were randomly divided into the']","['VADE', 'video-assisted discharge education (VADE', 'total hip replacement (THR) surgery', 'physiotherapy program', 'video-assisted discharge education', 'video-assisted discharge education program', 'physiotherapy']","['resting pain levels', ""Harris Hip Score, Nottingham Extended Activities of Daily Living Scale's movement score, Tampa Scale of Kinesiophobia, Patient Satisfaction Questionnaire"", 'patient satisfaction and functionality, reducing pain and kinesiophobia following THR', 'resting and activity pain levels', 'activities of daily living, functionality, and patient satisfaction']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",31.0,0.0239543,There was a significant difference between groups on resting pain levels in the first week and on resting and activity pain levels in the third month in favor of the VADE group (p < 0.05).,"[{'ForeName': 'Ozum', 'Initials': 'O', 'LastName': 'Cetinkaya Eren', 'Affiliation': 'Physiotherapy Program, Department of Therapy and Rehabilitation, Health Services Vocational School, Alanya Alaaddin Keykubat University, Alanya, Antalya, Turkey. ozum.eren@alanya.edu.tr.'}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Buker', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Hasan Atacan', 'Initials': 'HA', 'LastName': 'Tonak', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Akdeniz University, Antalya, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Urguden', 'Affiliation': 'Department of Orthopaedics and Traumatology, Faculty of Medicine, Akdeniz University, Antalya, Turkey.'}]",Scientific reports,['10.1038/s41598-022-07146-y']
2278,35197493,Type 1 diabetes and the challenges of emotional support in crisis situations: results from a randomized clinical trial of a multidisciplinary teleintervention.,"The association between type 1 diabetes and mental health disorders could be exacerbated in a stressful environment. This study aimed to evaluate the effectiveness of a teleguided intervention on emotional disorders in patients with type 1 diabetes during the COVID-19 outbreak. An open-label clinical trial was performed during the social distancing period in the COVID-19 outbreak in Brazil. Individuals with type 1 diabetes aged ≥ 18 years were randomized to receive a teleguided multidisciplinary intervention or the usual care plus an educational website access. The primary outcome was a positive screening for emotional disorders (Self Report Questionnaire 20) after a 16-week intervention. Secondary outcomes included evaluation of patients' perceptions of pandemic-related changes, diabetes-related emotional distress, eating disorders, and sleep disorders. Data were analyzed with the intent-to-treat principle. Fifty-eight individuals (mean age, 43.8 ± 13.6 years) were included (intervention group, n = 29; control group, n = 29). The primary outcome was not different between the groups. The intervention group felt more supported in their diabetes care during the social distancing period (82.8% vs. 48.3% in the control group, P < 0.01). Both groups reported a similar self-perceived worsening of physical activity habits and mental health during the outbreak. There was no benefit to using the telehealth strategy proposed for emotional disorders in patients with type 1 diabetes during the COVID-19 outbreak. Further studies are needed to determine the impact on metabolic parameters and to understand why it is so difficult to emotionally support these patients.Trail Registration: ClinicalTrials.gov (NCT04344210), 14/04/2020.",2022,There was no benefit to using the telehealth strategy proposed for emotional disorders in patients with type 1 diabetes during the COVID-19 outbreak.,"['patients with type 1 diabetes during the COVID-19 outbreak', 'Type 1 diabetes and the challenges of emotional support in crisis situations', 'Fifty-eight individuals (mean age, 43.8\u2009±\u200913.6\xa0years', 'Individuals with type 1 diabetes aged\u2009≥', '18\xa0years']","['teleguided multidisciplinary intervention or the usual care plus an educational website access', 'teleguided intervention']","[""evaluation of patients' perceptions of pandemic-related changes, diabetes-related emotional distress, eating disorders, and sleep disorders"", 'similar self-perceived worsening of physical activity habits and mental health', 'emotional disorders', 'positive screening for emotional disorders (Self Report Questionnaire 20']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",58.0,0.0799899,There was no benefit to using the telehealth strategy proposed for emotional disorders in patients with type 1 diabetes during the COVID-19 outbreak.,"[{'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Alessi', 'Affiliation': 'Medical Science Program: Endocrinology, Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos, 2350, prédio 12, 4° andar, Porto Alegre, RS, 90035-003, Brazil. janinealessi@gmail.com.'}, {'ForeName': 'Alice Scalzilli', 'Initials': 'AS', 'LastName': 'Becker', 'Affiliation': 'School of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Bibiana', 'Initials': 'B', 'LastName': 'Amaral', 'Affiliation': 'School of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Giovana Berger', 'Initials': 'GB', 'LastName': 'de Oliveira', 'Affiliation': 'School of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Debora Wilke', 'Initials': 'DW', 'LastName': 'Franco', 'Affiliation': 'Medical and Health Sciences Program, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Carolina Padilla', 'Initials': 'CP', 'LastName': 'Knijnik', 'Affiliation': 'School of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Gabriel Luiz', 'Initials': 'GL', 'LastName': 'Kobe', 'Affiliation': 'School of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'de Brito', 'Affiliation': 'Medical Science Program: Endocrinology, Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos, 2350, prédio 12, 4° andar, Porto Alegre, RS, 90035-003, Brazil.'}, {'ForeName': 'Taíse Rosa', 'Initials': 'TR', 'LastName': 'de Carvalho', 'Affiliation': 'Medical and Health Sciences Program, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Guilherme Heiden', 'Initials': 'GH', 'LastName': 'Telo', 'Affiliation': 'Medical and Health Sciences Program, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Beatriz D', 'Initials': 'BD', 'LastName': 'Schaan', 'Affiliation': 'Medical Science Program: Endocrinology, Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos, 2350, prédio 12, 4° andar, Porto Alegre, RS, 90035-003, Brazil.'}, {'ForeName': 'Gabriela Heiden', 'Initials': 'GH', 'LastName': 'Telo', 'Affiliation': 'Internal Medicine Department, Hospital São Lucas-Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}]",Scientific reports,['10.1038/s41598-022-07005-w']
2279,35197490,Interventional neurorehabilitation for promoting functional recovery post-craniotomy: a proof-of-concept.,"The human brain is a highly plastic 'complex' network-it is highly resilient to damage and capable of self-reorganisation after a large perturbation. Clinically, neurological deficits secondary to iatrogenic injury have very few active treatments. New imaging and stimulation technologies, though, offer promising therapeutic avenues to accelerate post-operative recovery trajectories. In this study, we sought to establish the safety profile for 'interventional neurorehabilitation': connectome-based therapeutic brain stimulation to drive cortical reorganisation and promote functional recovery post-craniotomy. In n = 34 glioma patients who experienced post-operative motor or language deficits, we used connectomics to construct single-subject cortical networks. Based on their clinical and connectivity deficit, patients underwent network-specific transcranial magnetic stimulation (TMS) sessions daily over five consecutive days. Patients were then assessed for TMS-related side effects and improvements. 31/34 (91%) patients were successfully recruited and enrolled for TMS treatment within two weeks of glioma surgery. No seizures or serious complications occurred during TMS rehabilitation and 1-week post-stimulation. Transient headaches were reported in 4/31 patients but improved after a single session. No neurological worsening was observed while a clinically and statistically significant benefit was noted in 28/31 patients post-TMS. We present two clinical vignettes and a video demonstration of interventional neurorehabilitation. For the first time, we demonstrate the safety profile and ability to recruit, enroll, and complete TMS acutely post-craniotomy in a high seizure risk population. Given the lack of randomisation and controls in this study, prospective randomised sham-controlled stimulation trials are now warranted to establish the efficacy of interventional neurorehabilitation following craniotomy.",2022,The human brain is a highly plastic 'complex' network-it is highly resilient to damage and capable of self-reorganisation after a large perturbation.,"['31/34', '34 glioma patients who experienced post-operative motor or language deficits, we used connectomics to construct single-subject cortical networks', '91%) patients were successfully recruited and enrolled for TMS treatment within two weeks of glioma surgery']","['Interventional neurorehabilitation', 'network-specific transcranial magnetic stimulation (TMS) sessions']","['seizures or serious complications', 'neurological worsening', 'Transient headaches']","[{'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0204096', 'cui_str': 'Neurological rehabilitation'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",34.0,0.0552119,The human brain is a highly plastic 'complex' network-it is highly resilient to damage and capable of self-reorganisation after a large perturbation.,"[{'ForeName': 'Anujan', 'Initials': 'A', 'LastName': 'Poologaindran', 'Affiliation': 'Brain Mapping Unit, Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Profyris', 'Affiliation': 'Netcare Linksfield Hospital, Johannesburg, South Africa.'}, {'ForeName': 'Isabella M', 'Initials': 'IM', 'LastName': 'Young', 'Affiliation': 'Department of Neurosurgery, Prince of Wales Private Hospital, Sydney, Australia.'}, {'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Dadario', 'Affiliation': 'Department of Neurosurgery, Prince of Wales Private Hospital, Sydney, Australia.'}, {'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Ahsan', 'Affiliation': 'Department of Neurosurgery, Prince of Wales Private Hospital, Sydney, Australia.'}, {'ForeName': 'Kassem', 'Initials': 'K', 'LastName': 'Chendeb', 'Affiliation': 'Department of Neurosurgery, Prince of Wales Private Hospital, Sydney, Australia.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Briggs', 'Affiliation': 'Department of Neurosurgery, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Teo', 'Affiliation': 'Department of Neurosurgery, Prince of Wales Private Hospital, Sydney, Australia.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Romero-Garcia', 'Affiliation': 'Brain Mapping Unit, Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Suckling', 'Affiliation': 'Brain Mapping Unit, Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Sughrue', 'Affiliation': 'Brain Mapping Unit, Department of Psychiatry, University of Cambridge, Cambridge, UK. sughruevs@gmail.com.'}]",Scientific reports,['10.1038/s41598-022-06766-8']
2280,35199421,Influence of ejection fraction on biomarker expression and response to spironolactone in people at risk of heart failure: findings from the HOMAGE trial.,"AIMS


Left ventricular ejection fraction (LVEF) can provide haemodynamic information and may influence the response to spironolactone and other heart failure (HF) therapies. We aimed to study patient characteristics and circulating protein associations with LVEF, and whether LVEF influenced the response to spironolactone.
METHODS AND RESULTS


HOMAGE enrolled patients aged >60 years at high risk of developing HF with a LVEF ≥45%. Overall, 527 patients were randomized to either spironolactone or standard of care for ≈9 months, and 276 circulating proteins were measured using Olink® technology. A total of 364 patients had available LVEF determined by the Simpson's biplane method. The respective LVEF tertiles were: tertile 1: <60% (n = 122), tertile 2: 60%-65% (n = 121), and tertile 3: >65% (n = 121). Patients with a LVEF >65% had smaller left ventricular chamber size and volumes, and lower natriuretic peptide levels. Compared to patients with a LVEF <60%, those with LVEF >65% had higher levels of circulating c-c motif chemokine ligand-23 and interleukin-8, and lower levels of tissue plasminogen activator, brain natriuretic peptide (BNP), S100 calcium binding protein A12, and collagen type I alpha 1 chain (COL1A1). Spironolactone significantly reduced the circulating levels of BNP and COL1A1 without significant treatment-by-LVEF heterogeneity: BNP change β = -0.36 log 2  and COL1A1 change β = -0.16 log 2  (p < 0.0001 for both; interaction p > 0.1 for both). Spironolactone increased LVEF from baseline to month 9 by 1.1% (p = 0.007).
CONCLUSION


Patients with higher LVEF had higher circulating levels of chemokines and inflammatory markers and lower levels of stretch, injury, and fibrosis markers. Spironolactone reduced the circulating levels of natriuretic peptides and type 1 collagen, and increased LVEF.",2022,"Spironolactone increased LVEF from baseline to month 9 by 1.1%, P = 0.007.
","['527 patients', ""364 patients had available LVEF determined by the Simpson's bi-plane method"", 'HOMAGE enrolled patients aged >60\u2009years at high risk of developing HF with a LVEF ≥45', 'people at risk of heart failure']","['Spironolactone', 'spironolactone', 'Left ventricular ejection fraction (LVEF', 'spironolactone or standard-of-care for ≈9\u2009months']","['circulating levels of chemokines and inflammatory markers and lower levels of stretch, injury, and fibrosis markers', 'circulating levels of BNP and COL1A1', 'levels of circulating c-c motif chemokine ligand-23 and interleukin-8, and lower levels of tissue plasminogen activator, BNP, S100 calcium binding protein A12, and collagen type', 'LVEF', 'circulating levels of natriuretic peptides and type 1 collagen, and increased LVEF', 'smaller LV chamber size and volumes, and lower natriuretic peptide levels']","[{'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0972255', 'cui_str': 'type I collagen alpha 1'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0389073', 'cui_str': 'S100A12 protein, human'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]",527.0,0.0909223,"Spironolactone increased LVEF from baseline to month 9 by 1.1%, P = 0.007.
","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'Cardiovascular Research and Development Center, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Porto, Portugal.'}, {'ForeName': 'Job A J', 'Initials': 'JAJ', 'LastName': 'Verdonschot', 'Affiliation': 'Department of Clinical Genetics, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Girerd', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, U1116, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Bozec', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, U1116, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Pellicori', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Collier', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Mariottoni', 'Affiliation': 'Department of Cardiology, Cortona Hospital, Arezzo, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Cosmi', 'Affiliation': 'Department of Cardiology, Cortona Hospital, Arezzo, Italy.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hazebroek', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Cuthbert', 'Affiliation': 'Department of Cardiology, University of Hull, Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Petutschnigg', 'Affiliation': 'Department of Internal Medicine and Cardiology, Campus Virchow Klinikum, Charité University Medicine Berlin and German Centre for Cardiovascular Research (DZHK), Berlin, Germany.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Heymans', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Staessen', 'Affiliation': 'Studies Coordinating Centre, Research Unit Hypertension and Cardiovascular Epidemiology, Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine and Cardiology, Campus Virchow Klinikum, Charité University Medicine Berlin and German Centre for Cardiovascular Research (DZHK), Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Edelman', 'Affiliation': 'Department of Internal Medicine and Cardiology, Campus Virchow Klinikum, Charité University Medicine Berlin and German Centre for Cardiovascular Research (DZHK), Berlin, Germany.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Clark', 'Affiliation': 'Department of Cardiology, University of Hull, Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Díez', 'Affiliation': 'Program of Cardiovascular Diseases, CIMA Universidad de Navarra and IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Arantxa', 'Initials': 'A', 'LastName': 'González', 'Affiliation': 'Program of Cardiovascular Diseases, CIMA Universidad de Navarra and IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, U1116, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing and British Heart Foundation Centre of Research Excellence, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, U1116, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, France.""}]",European journal of heart failure,['10.1002/ejhf.2455']
2281,35200236,Tailoring Can Improve Consumers' Hygienic Food-Handling Behavior to Reduce the Transmission Risk of Antimicrobial-Resistant Bacteria through Food.,"Antimicrobial-resistant (AMR) bacteria spread via food to humans and can seriously impair infection treatment. Hygienic food handling is an effective measure to avoid the transmission of bacteria. Therefore, we tested three types of interventions (tailored, generic, and no intervention) for their effectiveness in improving consumers' hygienic food handling against the spread of antimicrobial-resistant bacteria through foods in a longitudinal randomized control trial. We based the determinants of hygienic food-handling behavior on the Health Action Process Approach (HAPA). The tailored intervention raised self-reported hygienic food handling, self-efficacy, and perceived likelihood of risk compared to no intervention. Moreover, interventions yielded different effects for participants with high vs. low intentions to improve their food-handling behavior. However, there were no differences between the tailored and generic interventions. More research is needed to find out whether including other behavior change techniques in the tailored intervention may increase the effect of tailoring.",2022,"The tailored intervention raised self-reported hygienic food handling, self-efficacy, and perceived likelihood of risk compared to no intervention.",[],['Antimicrobial-resistant (AMR) bacteria'],[],[],"[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",[],,0.0207315,"The tailored intervention raised self-reported hygienic food handling, self-efficacy, and perceived likelihood of risk compared to no intervention.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Freivogel', 'Affiliation': 'School of Applied Psychology, University of Applied Sciences and Arts Northwestern Switzerland, Riggenbachstrasse 16, 4600 Olten, Switzerland.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lehmann', 'Affiliation': 'School of Applied Psychology, University of Applied Sciences and Arts Northwestern Switzerland, Riggenbachstrasse 16, 4600 Olten, Switzerland.'}, {'ForeName': 'Vivianne H M', 'Initials': 'VHM', 'LastName': 'Visschers', 'Affiliation': 'School of Applied Psychology, University of Applied Sciences and Arts Northwestern Switzerland, Riggenbachstrasse 16, 4600 Olten, Switzerland.'}]","European journal of investigation in health, psychology and education",['10.3390/ejihpe12020014']
2282,35200566,"Feasibility, Acceptability, and Clinical Significance of a Dyadic, Web-Based, Psychosocial and Physical Activity Self-Management Program ( TEMPO ) Tailored to the Needs of Men with Prostate Cancer and Their Caregivers: A Multi-Center Randomized Pilot Trial.","BACKGROUND


Prostate cancer is the most common cancer diagnosis among men. Family caregivers (often female spouses) play a key role in ensuring patients' needs are met, frequently assuming their role with no formal training, which can contribute to a high burden. The purpose of this study was to pilot  TEMPO -the first dyadic, Tailored, wEb-based, psychosocial and physical activity self-Management PrOgram for men with prostate cancer and their caregivers.
METHODS


49 men with prostate cancer and their caregivers were randomized to  TEMPO  or usual care. Baseline and follow-up questionnaires were completed to assess feasibility, acceptability, and clinical significance. A priori benchmarks for these outcomes were set. Thirteen exit interviews were conducted to further explore acceptability.
RESULTS


Feasibility benchmarks were met with the exception for recruitment with on average 6.1 dyads recruited/month (benchmark: 8 dyads/month). Benchmarks of acceptability focused on attrition (<25%) and system usability, which were met. Using the strict criteria for adherence of 100% of the module viewed and participants spending at least 15 min on the module, 45% of participants were adherent. The clinical significance on anxiety and quality of life was supported for caregivers, and mostly supported for the men with prostate cancer.
CONCLUSION


This pilot trial was successful, with minor modifications needed prior to a large trial.",2022,"The clinical significance on anxiety and quality of life was supported for caregivers, and mostly supported for the men with prostate cancer.
","['men with prostate cancer and their caregivers', 'Family caregivers (often female spouses', 'men with prostate cancer', 'Men with Prostate Cancer and Their Caregivers', '49 men with prostate cancer and their caregivers']","['TEMPO  or usual care', 'TEMPO', 'Dyadic, Web-Based, Psychosocial and Physical Activity Self-Management Program ( TEMPO ']","['anxiety and quality of life', 'feasibility, acceptability, and clinical significance']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}]","[{'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",49.0,0.114724,"The clinical significance on anxiety and quality of life was supported for caregivers, and mostly supported for the men with prostate cancer.
","[{'ForeName': 'Sylvie D', 'Initials': 'SD', 'LastName': 'Lambert', 'Affiliation': ""St. Mary's Research Centre, Montreal, QC H3T 1M5, Canada.""}, {'ForeName': 'Lindsay R', 'Initials': 'LR', 'LastName': 'Duncan', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montreal, QC H3A 0G4, Canada.'}, {'ForeName': 'S Nicole', 'Initials': 'SN', 'LastName': 'Culos-Reed', 'Affiliation': 'Health and Wellness Lab, Thrive Centre, Faculty of Kinesiology, Department of Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hallward', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montreal, QC H3A 0G4, Canada.'}, {'ForeName': 'Celestia S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'Vancouver Prostate Centre, Prostate Cancer Supportive Care Program, Department of Urologic Sciences, University of British Columbia, Vancouver, BC V6T 1Z4, Canada.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Loban', 'Affiliation': ""St. Mary's Research Centre, Montreal, QC H3T 1M5, Canada.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Katz', 'Affiliation': 'Cancer Care Manitoba, Winnipeg, MB R3E 0V9, Canada.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'De Raad', 'Affiliation': ""St. Mary's Research Centre, Montreal, QC H3T 1M5, Canada.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Ellis', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON M4N 3M5, Canada.'}, {'ForeName': 'Melissa B', 'Initials': 'MB', 'LastName': 'Korman', 'Affiliation': 'Sunnybrook, Research Institute Department of Evaluative Clinical Sciences, Toronto, ON M5S 1A1, Canada.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Sears', 'Affiliation': 'University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Ibberson', 'Affiliation': ""St. Mary's Research Centre, Montreal, QC H3T 1M5, Canada.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Walker', 'Affiliation': 'Department of Oncology & Psychology, University of Calgary, Calgary, AB T2P 4Z6, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Belzile', 'Affiliation': ""St. Mary's Research Centre, Montreal, QC H3T 1M5, Canada.""}, {'ForeName': 'Paramita', 'Initials': 'P', 'LastName': 'Saha-Chaudhuri', 'Affiliation': 'Department of Mathematics and Statistics, University of Vermont, Burlington, VT 05405, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McTaggart-Cowan', 'Affiliation': 'Canadian Centre for Applied Research in Cancer Control, Cancer Control Research, BC Cancer, Faculty of Health Sciences, Simon Fraser University, Burnaby, BC V5A 1S6, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Peacock', 'Affiliation': 'Canadian Centre for Applied Research in Cancer Control, Cancer Control Research, BC Cancer, Faculty of Health Sciences, Simon Fraser University, Burnaby, BC V5A 1S6, Canada.'}]","Current oncology (Toronto, Ont.)",['10.3390/curroncol29020067']
2283,34887544,A randomized trial of online single-session interventions for adolescent depression during COVID-19.,"The COVID-19 pandemic has potentially increased the risk for adolescent depression. Even pre-pandemic, <50% of youth with depression accessed care, highlighting needs for accessible interventions. Accordingly, this randomized controlled trial (ClinicalTrials.gov: NCT04634903 ) tested online single-session interventions (SSIs) during COVID-19 in adolescents with elevated depression symptoms (N = 2,452, ages 13-16). Adolescents from all 50 US states, recruited via social media, were randomized to one of three SSIs: a behavioural activation SSI, an SSI teaching that traits are malleable and a supportive control. We tested each SSI's effects on post-intervention outcomes (hopelessness and agency) and three-month outcomes (depression, hopelessness, agency, generalized anxiety, COVID-19-related trauma and restrictive eating). Compared with the control, both active SSIs reduced three-month depressive symptoms (Cohen's d = 0.18), decreased post-intervention and three-month hopelessness (d = 0.16-0.28), increased post-intervention agency (d = 0.15-0.31) and reduced three-month restrictive eating (d = 0.12-17). Several differences between active SSIs emerged. These results confirm the utility of free-of-charge, online SSIs for high-symptom adolescents, even in the high-stress COVID-19 context.",2022,"Compared with the control, both active SSIs reduced three-month depressive symptoms (Cohen's d = 0.18), decreased post-intervention and three-month hopelessness (d = 0.16-0.28), increased post-intervention agency (d = 0.15-0.31) and reduced three-month restrictive eating (d = 0.12-17).","['adolescents with elevated depression symptoms (N\u2009=\u20092,452, ages 13-16', 'Adolescents from all 50 US states, recruited via social media', 'adolescent depression during COVID-19']","['online single-session interventions', 'behavioural activation SSI, an SSI teaching that traits are malleable and a supportive control', 'online single-session interventions (SSIs']","['active SSIs reduced three-month depressive symptoms', 'post-intervention outcomes (hopelessness and agency) and three-month outcomes (depression, hopelessness, agency, generalized anxiety, COVID-19-related trauma and restrictive eating']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]",,0.160198,"Compared with the control, both active SSIs reduced three-month depressive symptoms (Cohen's d = 0.18), decreased post-intervention and three-month hopelessness (d = 0.16-0.28), increased post-intervention agency (d = 0.15-0.31) and reduced three-month restrictive eating (d = 0.12-17).","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Schleider', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, USA. jessica.schleider@stonybrook.edu.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Mullarkey', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Kathryn R', 'Initials': 'KR', 'LastName': 'Fox', 'Affiliation': 'Department of Psychology, University of Denver, Denver, CO, USA.'}, {'ForeName': 'Mallory L', 'Initials': 'ML', 'LastName': 'Dobias', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Shroff', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Erica A', 'Initials': 'EA', 'LastName': 'Hart', 'Affiliation': 'Department of Psychology, University of Denver, Denver, CO, USA.'}, {'ForeName': 'Chantelle A', 'Initials': 'CA', 'LastName': 'Roulston', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, USA.'}]",Nature human behaviour,['10.1038/s41562-021-01235-0']
2284,35202081,The Effect of the NorGeP-NH on Quality of Life and Drug Prescriptions in Norwegian Nursing Homes: A Randomized Controlled Trial.,"BACKGROUND


The effect of the Norwegian General Practice-Nursing Home (NorGeP-NH) criteria has never been tested on clinical outcomes in nursing home (NH) residents. We performed a cluster-randomized trial in Norwegian NHs and tested the effect of NorGeP-NH on QoL (primary outcome), medication prescriptions, and physical and mental health (secondary outcomes) for the enrolled residents; Methods: Fourteen NHs were randomized into intervention NHs (iNHs) and control NHs (cNHs). After baseline data collection, physicians performed NorGeP-NH on the enrolled residents. We assessed the difference between cNHs and iNHs in the change in primary outcome from baseline to 12 weeks and secondary outcomes from baseline to eight and 12 weeks by linear mixed models; Results: One hundred and eight residents (13 lost to follow-up) and 109 residents (nine lost to follow-up) were randomized to iNHs and cNHs, respectively. Difference in change in QoL at 12 weeks between cNHs and iNHs was not statistically significant (mean (95% CI)): -1.51 (-3.30; 0.28),  p  = 0.101). We found no significant change in drug prescriptions over time. Difference in depression scores between cNHs and iNHs was statistically significant after 12 weeks.
CONCLUSIONS


Our intervention did not affect QoL or drug prescriptions, but reduced depression scores in the iNHs. NorGeP-NH may be a useful tool, but its effect on clinical outcomes may be scarce in NH residents. Further studies about the effectiveness of NorGeP-NH in other healthcare contexts and settings are recommended.",2022,Difference in change in QoL at 12 weeks between cNHs and iNHs was not statistically significant (mean (95% CI)): -1.51,"['enrolled residents; Methods: Fourteen NHs', 'Norwegian Nursing Homes', 'One hundred and eight residents (13 lost to follow-up) and 109 residents (nine lost to follow-up', 'nursing home (NH) residents']","['NorGeP-NH', 'intervention NHs (iNHs) and control NHs (cNHs']","['QoL', 'depression scores', 'Quality of Life and Drug Prescriptions', 'QoL (primary outcome), medication prescriptions, and physical and mental health']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033081', 'cui_str': 'Drug prescription'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",14.0,0.259426,Difference in change in QoL at 12 weeks between cNHs and iNHs was not statistically significant (mean (95% CI)): -1.51,"[{'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Callegari', 'Affiliation': 'Østfold Hospital Trust, 1714 Grålum, Norway.'}, {'ForeName': 'Jurate Šaltytė', 'Initials': 'JŠ', 'LastName': 'Benth', 'Affiliation': 'Institute of Clinical Medicine, Campus Ahus, University of Oslo, 0372 Oslo, Norway.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Selbæk', 'Affiliation': 'Faculty of Medicine, University of Oslo, 0372 Oslo, Norway.'}, {'ForeName': 'Cato', 'Initials': 'C', 'LastName': 'Grønnerød', 'Affiliation': 'Østfold Hospital Trust, 1714 Grålum, Norway.'}, {'ForeName': 'Sverre', 'Initials': 'S', 'LastName': 'Bergh', 'Affiliation': 'Research Centre for Age-Related Functional Decline and Diseases, Innlandet Hospital Trust, 2312 Ottestad, Norway.'}]","Pharmacy (Basel, Switzerland)",['10.3390/pharmacy10010032']
2285,35203960,Feasibility of a Telerehabilitation Adaptation of the  Be Clear  Speech Treatment Program for Non-Progressive Dysarthria.,"This study evaluated the feasibility and outcomes of a telerehabilitation adaptation of the  Be Clear  speech treatment program for adults with non-progressive dysarthria to determine clinical delivery viability and future research directions. Treatment effects on speech clarity, intelligibility, communication effectiveness, and participation, as well as psychosocial outcomes in 15 participants with non-progressive dysarthria, were explored. Intervention involved daily 1-h online sessions (4 days per week for 4 weeks, totalling 16 sessions) and daily home practice. Outcome measures were obtained at baseline (PRE), post-treatment (POST), and 12 weeks following treatment (FUP). Feasibility measures targeting participant satisfaction, treatment adherence and fidelity, and technical viability were also employed. The programme was feasible concerning technical viability and implementation, treatment adherence and fidelity. High levels of participant satisfaction were reported. Increases in overall ratings of communication participation and effectiveness were identified at POST and FUP. Reductions in speech rate were identified at FUP. Improvements in aspects of lingual and laryngeal function were also noted after treatment. Over time, improvements relating to the negative impact of dysarthria were identified. Naïve listeners perceived negligible changes in speech clarity following treatment. Online delivery of the  Be Clear  speech treatment program was feasible, and some positive speech benefits were observed. Due to the small sample size included in this research, statistically significant findings related to speech outcomes must be interpreted with caution. An adequately powered randomised controlled trial of  Be Clear  online is warranted to evaluate treatment efficacy.",2022,"Treatment effects on speech clarity, intelligibility, communication effectiveness, and participation, as well as psychosocial outcomes in 15 participants with non-progressive dysarthria, were explored.","['Non-Progressive Dysarthria', '15 participants with non-progressive dysarthria', 'adults with non-progressive dysarthria']","['telerehabilitation adaptation of the  Be Clear  speech treatment program', 'Telerehabilitation Adaptation of the  Be Clear  Speech Treatment Program']","['speech clarity', 'High levels of participant satisfaction', 'speech rate', 'speech clarity, intelligibility, communication effectiveness, and participation, as well as psychosocial outcomes', 'participant satisfaction, treatment adherence and fidelity, and technical viability', 'overall ratings of communication participation and effectiveness', 'lingual and laryngeal function']","[{'cui': 'C3839460', 'cui_str': 'Non-progressive'}, {'cui': 'C0013362', 'cui_str': 'Dysarthria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0589416', 'cui_str': 'Intelligibility'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",15.0,0.0496972,"Treatment effects on speech clarity, intelligibility, communication effectiveness, and participation, as well as psychosocial outcomes in 15 participants with non-progressive dysarthria, were explored.","[{'ForeName': 'Brooke-Mai', 'Initials': 'BM', 'LastName': 'Whelan', 'Affiliation': 'Recover Injury Research Centre, Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane 4072, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Theodoros', 'Affiliation': 'Recover Injury Research Centre, Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane 4072, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Cahill', 'Affiliation': 'Recover Injury Research Centre, Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane 4072, Australia.'}, {'ForeName': 'Atiyeh', 'Initials': 'A', 'LastName': 'Vaezipour', 'Affiliation': 'Recover Injury Research Centre, Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane 4072, Australia.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Vogel', 'Affiliation': 'Centre for the Neuroscience of Speech, Department of Audiology and Speech Pathology, Melbourne School of Health Sciences, The University of Melbourne, Melbourne 3010, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Finch', 'Affiliation': 'Faculty of Health and Behavioural Sciences, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane 4072, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Farrell', 'Affiliation': 'The Princess Alexandra Hospital, Metro South Hospital and Health Service, Queensland Health, Brisbane 4102, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cardell', 'Affiliation': 'Menzies Health Institute Queensland, School of Medicine and Dentistry, Griffith University, Gold Coast 4215, Australia.'}]",Brain sciences,['10.3390/brainsci12020197']
2286,35203894,Non-Pharmacological Interventions for Wandering/Aberrant Motor Behaviour in Patients with Dementia.,"BACKGROUND


Aberrant motor behaviour or wandering refers to aimless movement without a specific purpose. Wandering is common in patients with dementia and leads to early institutionalization and caregivers' burden. Non-pharmacological interventions should be also considered as a first-line solution for the wandering because current pharmacological treatment has serious side-effects.
METHODS


A cross-over randomised controlled trial (RCT) with 60 participants of all stages and different types of dementia was conducted in Greece. The sample was randomly assigned in 6 different groups of 10 participants each. Every intervention lasted for 5 days, and there were 2 days as a wash-out period. There was no drop-out rate. The measurements used were the Mini Mental State Examination (MMSE), Addenbrooke's Cognitive Examination Revised (ACE-R), Geriatric Depression Scale (GDS), Functional Rating Scale for Symptoms in Dementia (FRSSD), and Neuropsychiatric Inventory (NPI). The interventions that were evaluated were reminiscence therapy (RT), music therapy (MT), and physical exercise (PE).
RESULTS


NPI scores were reduced in the group receiving PE ( p  = 0.006). When MT ( p  = 0.018) follows PE, wandering symptoms are reduced further. RT should follow MT in order to reduce wandering more ( p  = 0.034). The same combination was effective for the caregivers' burden as well; PE ( p  = 0.004), MT ( p  = 0.036), RT ( p  = 0.039).
CONCLUSIONS


An effective combination that can reduce wandering symptoms in all stages and types of dementia was found: The best order was PH-MT-RT. The same combination in the same order reduced caregivers' burden.",2022,"The same combination was effective for the caregivers' burden as well; PE ( p  = 0.004), MT ( p  = 0.036), RT ( p  = 0.039).
","['patients with dementia', '60 participants of all stages and different types of dementia was conducted in Greece', 'Patients with Dementia']",[],"['NPI scores', ""Mini Mental State Examination (MMSE), Addenbrooke's Cognitive Examination Revised (ACE-R), Geriatric Depression Scale (GDS), Functional Rating Scale for Symptoms in Dementia (FRSSD), and Neuropsychiatric Inventory (NPI"", 'reminiscence therapy (RT), music therapy (MT), and physical exercise (PE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018226', 'cui_str': 'Greece'}]",[],"[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C2919447', 'cui_str': ""Addenbrooke's cognitive examination revised""}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0150321', 'cui_str': 'Reminiscence therapy'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0382435,"The same combination was effective for the caregivers' burden as well; PE ( p  = 0.004), MT ( p  = 0.036), RT ( p  = 0.039).
","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Dimitriou', 'Affiliation': '1st Department of Neurology, Aristotle University of Thessaloniki, 44 Salaminos Street, Halandri, 15232 Athens, Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Papatriantafyllou', 'Affiliation': ""3rd Age Center IASIS, 2nd Neurology Department, University of Athens, 'Attikon' Hospital, 73 Krimeas str., Glyfada, 16562 Athens, Greece.""}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Konsta', 'Affiliation': '1st Department of Psychiatry, ""Papageorgiou"" General Hospital of Thessaloniki, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kazis', 'Affiliation': '3rd Neurology Department, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece.'}, {'ForeName': 'Loukas', 'Initials': 'L', 'LastName': 'Athanasiadis', 'Affiliation': '1st Department of Psychiatry, ""Papageorgiou"" General Hospital of Thessaloniki, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Ioannidis', 'Affiliation': '2nd Department of Neurology, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece.'}, {'ForeName': 'Efrosini', 'Initials': 'E', 'LastName': 'Koutsouraki', 'Affiliation': '3rd Neurology Department, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tegos', 'Affiliation': '3rd Neurology Department, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Tsolaki', 'Affiliation': '3rd Neurology Department, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece.'}]",Brain sciences,['10.3390/brainsci12020130']
2287,35204301,"CoenzymeQ10 and Ischemic Preconditioning Potentially Prevent Tourniquet-Induced Ischemia/Reperfusion in Knee Arthroplasty, but Combined Pretreatment Possibly Neutralizes Their Beneficial Effects.","Tourniquet (TQ) use during total knee arthroplasty (TKA) induces ischemia/reperfusion (I/R) injury, resulting in mitochondrial dysfunction. This study aims to determine the effects of coenzyme Q10 (CoQ10) and ischemic preconditioning (IPC), either alone or in combination, on I/R-induced mitochondrial respiration alteration in peripheral blood mononuclear cells (PBMCs) and pain following TKA. Forty-four patients were allocated into four groups: control, CoQ10, IPC, and CoQ10 + IPC. CoQ10 dose was 300 mg/day for 28 days. IPC protocol was three cycles of 5/5-min I/R time. Mitochondrial oxygen consumption rates (OCRs) of PBMCs were measured seven times, at baseline and during ischemic/reperfusion phases, with XFe 96 extracellular flux analyzer. Postoperative pain was assessed for 48 h. CoQ10 improved baseline mitochondrial uncoupling state; however, changes in OCRs during the early phase of I/R were not significantly different from the placebo. Compared to ischemic data, IPC transiently increased basal OCR and ATP production at 2 h after reperfusion. Clinically, CoQ10 significantly decreased pain scores and morphine requirements at 24 h. CoQ10 + IPC abolished analgesic effect of CoQ10 and mitochondrial protection of IPC. In TKA with TQ, IPC enhanced mitochondrial function by a transient increase in basal and ATP-linked respiration, and CoQ10 provides postoperative analgesic effect. Surprisingly, CoQ10 + IPC interferes with beneficial effects of each intervention.",2022,"Clinically, CoQ10 significantly decreased pain scores and morphine requirements at 24 h.",['Forty-four patients'],"['placebo', 'control, CoQ10, IPC, and CoQ10 + IPC', 'CoQ10 + IPC', 'total knee arthroplasty (TKA', 'coenzyme Q10 (CoQ10) and ischemic preconditioning (IPC', 'CoenzymeQ10 and Ischemic Preconditioning', 'Tourniquet (TQ']","['Postoperative pain', 'peripheral blood mononuclear cells (PBMCs) and pain following TKA', 'pain scores and morphine requirements', 'Mitochondrial oxygen consumption rates (OCRs) of PBMCs', 'basal OCR and ATP production']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}]",44.0,0.0537222,"Clinically, CoQ10 significantly decreased pain scores and morphine requirements at 24 h.","[{'ForeName': 'Prangmalee', 'Initials': 'P', 'LastName': 'Leurcharusmee', 'Affiliation': 'Neurophysiology Unit, Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Passakorn', 'Initials': 'P', 'LastName': 'Sawaddiruk', 'Affiliation': 'Neurophysiology Unit, Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Yodying', 'Initials': 'Y', 'LastName': 'Punjasawadwong', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Nantawit', 'Initials': 'N', 'LastName': 'Sugundhavesa', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Kasisin', 'Initials': 'K', 'LastName': 'Klunklin', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Siam', 'Initials': 'S', 'LastName': 'Tongprasert', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Patraporn', 'Initials': 'P', 'LastName': 'Sitilertpisan', 'Affiliation': 'Faculty of Associated Medical Science, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Thidarat', 'Initials': 'T', 'LastName': 'Jaiwongkam', 'Affiliation': 'Neurophysiology Unit, Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Nattayaporn', 'Initials': 'N', 'LastName': 'Apaijai', 'Affiliation': 'Neurophysiology Unit, Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Nipon', 'Initials': 'N', 'LastName': 'Chattipakorn', 'Affiliation': 'Neurophysiology Unit, Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Siriporn C', 'Initials': 'SC', 'LastName': 'Chattipakorn', 'Affiliation': 'Neurophysiology Unit, Cardiac Electrophysiology Research and Training Center, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox11020419']
2288,35204098,"Pharmacokinetics and Pharmacodynamics of Key Components of a Standardized  Centella asiatica  Product in Cognitively Impaired Older Adults: A Phase 1, Double-Blind, Randomized Clinical Trial.","Centella asiatica  is reputed in Eastern medicine to improve cognitive function in humans. Preclinical studies have demonstrated that aqueous extracts of  C. asiatica  improve cognition in mouse models of aging and Alzheimer's disease (AD) through the modulation of mitochondrial biogenesis and nuclear factor-erythroid-2-related factor 2 ( Nrf2) -dependent antioxidant response genes. This randomized, double-blind, crossover Phase I trial explored the oral bioavailability and pharmacokinetics of key compounds from two doses (2 g and 4 g) of a standardized  C. asiatica  aqueous extract product (CAP), over 10 h, in four mildly demented older adults on cholinesterase inhibitor therapy. The analysis focused on triterpenes (TTs) and caffeoylquinic acids (CQAs), which are known to contribute to  C. asiatica 's neurological activity. The acute safety of CAP and the effects on  NRF2  gene expression in peripheral blood mononuclear cells were evaluated. Single administration of 2 g or 4 g of CAP was safe and well-tolerated. The TT aglycones, asiatic acid and madecassic acid, were identified in plasma and urine, while the parent glycosides, asiaticoside and madecassoside, although abundant in CAP, were absent in plasma and had limited renal excretion. Similarly, mono- and di-CQAs showed delayed absorption and limited presence in plasma or urine, while the putative metabolites of these compounds showed detectable plasma pharmacokinetic profiles and urinary excretion. CAP elicited a temporal change in  NRF2  gene expression, mirroring the TT aglycone's pharmacokinetic curve in a paradoxical dose-dependent manner. The oral bioavailability of active compounds or their metabolites,  NRF2  target engagement, and the acute safety and tolerability of CAP support the validity of using CAP in future clinical studies.",2022,"CAP elicited a temporal change in  NRF2  gene expression, mirroring the TT aglycone's pharmacokinetic curve in a paradoxical dose-dependent manner.","['Impaired Older Adults', 'Cognitively', 'four mildly demented older adults on cholinesterase inhibitor therapy', 'humans']","['standardized  C. asiatica  aqueous extract product (CAP', 'CAP']","['delayed absorption and limited presence in plasma or urine', 'plasma pharmacokinetic profiles and urinary excretion', 'safe and well-tolerated', 'TT aglycones, asiatic acid and madecassic acid']","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0008425', 'cui_str': 'Cholinesterase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0304518', 'cui_str': 'Aglycone'}, {'cui': 'C0081660', 'cui_str': 'asiatic acid'}, {'cui': 'C0065501', 'cui_str': 'madecassic acid'}]",,0.251247,"CAP elicited a temporal change in  NRF2  gene expression, mirroring the TT aglycone's pharmacokinetic curve in a paradoxical dose-dependent manner.","[{'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Wright', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Bollen', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'David', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Alex B', 'Initials': 'AB', 'LastName': 'Speers', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Mikah S', 'Initials': 'MS', 'LastName': 'Brandes', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Nora E', 'Initials': 'NE', 'LastName': 'Gray', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Alcázar Magaña', 'Affiliation': 'Department of Chemistry, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'McClure', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Jan F', 'Initials': 'JF', 'LastName': 'Stevens', 'Affiliation': 'Department of Pharmaceutical Sciences, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Claudia S', 'Initials': 'CS', 'LastName': 'Maier', 'Affiliation': 'Department of Chemistry, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Quinn', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Amala', 'Initials': 'A', 'LastName': 'Soumyanath', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR 97239, USA.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox11020215']
2289,35206179,Molecular Hydrogen Positively Affects Physical and Respiratory Function in Acute Post-COVID-19 Patients: A New Perspective in Rehabilitation.,"Molecular hydrogen (H 2 ) is potentially a novel therapeutic gas for acute post-coronavirus disease 2019 (COVID-19) patients because it has antioxidative, anti-inflammatory, anti-apoptosis, and antifatigue properties. The aim of this study was to determine the effect of 14 days of H 2  inhalation on the respiratory and physical fitness status of acute post-COVID-19 patients. This randomized, single-blind, placebo-controlled study included 26 males (44 ± 17 years) and 24 females (38 ± 12 years), who performed a 6-min walking test (6 MWT) and pulmonary function test, specifically forced vital capacity (FVC) and expiratory volume in the first second (FEV1). Symptomatic participants were recruited between 21 and 33 days after a positive polymerase chain reaction test. The experiment consisted of H 2 /placebo inhalation, 2 × 60 min/day for 14 days. Results showed that H 2  therapy, compared with placebo, significantly increased 6 MWT distance by 64 ± 39 m, FVC by 0.19 ± 0.24 L, and, in FEV1, by 0.11 ± 0.28 L (all  p  ≤ 0.025). In conclusion, H 2  inhalation had beneficial health effects in terms of improved physical and respiratory function in acute post-COVID-19 patients. Therefore, H 2  inhalation may represent a safe, effective approach for accelerating early function restoration in post-COVID-19 patients.",2022,"Results showed that H 2  therapy, compared with placebo, significantly increased 6 MWT distance by 64 ± 39 m, FVC by 0.19 ± 0.24 L, and, in FEV1, by 0.11 ± 0.28 L (all  p  ≤ 0.025).","['acute post-COVID-19 patients', '26 males (44 ± 17 years) and 24 females (38 ± 12 years', 'Acute Post-COVID-19 Patients', 'Symptomatic participants were recruited between 21 and 33 days after a positive polymerase chain reaction test']",['placebo'],"['6-min walking test (6 MWT) and pulmonary function test, specifically forced vital capacity (FVC) and expiratory volume in the first second (FEV1', 'physical and respiratory function', '6 MWT distance']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",26.0,0.0427263,"Results showed that H 2  therapy, compared with placebo, significantly increased 6 MWT distance by 64 ± 39 m, FVC by 0.19 ± 0.24 L, and, in FEV1, by 0.11 ± 0.28 L (all  p  ≤ 0.025).","[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Botek', 'Affiliation': 'Faculty of Physical Culture, Palacký University Olomouc, 771 11 Olomouc, Czech Republic.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Krejčí', 'Affiliation': 'Faculty of Physical Culture, Palacký University Olomouc, 771 11 Olomouc, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Valenta', 'Affiliation': 'Faculty of Physical Culture, Palacký University Olomouc, 771 11 Olomouc, Czech Republic.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McKune', 'Affiliation': 'Research Institute for Sport and Exercise (UCRISE), University of Canberra, Bruce, ACT 2617, Australia.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Sládečková', 'Affiliation': 'Faculty of Physical Culture, Palacký University Olomouc, 771 11 Olomouc, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Konečný', 'Affiliation': 'Faculty of Health Sciences, Palacký University Olomouc, 775 15 Olomouc, Czech Republic.'}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Klimešová', 'Affiliation': 'Faculty of Physical Culture, Palacký University Olomouc, 771 11 Olomouc, Czech Republic.'}, {'ForeName': 'Dalibor', 'Initials': 'D', 'LastName': 'Pastucha', 'Affiliation': 'Clinic of Rehabilitation and Physical Medicine, University Hospital Ostrava, 708 52 Ostrava, Czech Republic.'}]",International journal of environmental research and public health,['10.3390/ijerph19041992']
2290,35206167,"The Effect of the ""Colorful Eating Is Healthy Eating"" Long-Term Nutrition Education Program for 3- to 6-Year-Olds on Eating Habits in the Family and Parental Nutrition Knowledge.","BACKGROUND


Effective strategies for improving eating habits and dietary intake in preschoolers are essential for reducing the risk of chronic non-infectious diseases in later life. The aim of this study was to evaluate the effect of long-term nutrition education for 3- to 6-year-olds on parental nutrition knowledge.
METHODS


The study was conducted as part of the ""Colorful Eating is Healthy Eating"" nutrition education program that has been implemented in kindergartens in Lublin since 2016. A total of 11 kindergartens were involved in this stage of the program, and 733 parents consented to participate in the project. The study was divided into three stages. In the first stage all parents completed a questionnaire containing 54 items. In the next stage, 211 children from four randomly selected kindergartens participated in the ""Colorful Eating Is Healthy Eating"" educational program that lasted 7 months. In the third stage of the study, the parents of children who had completed the 7-month educational program and the parents of control group children once again completed the questionnaire.
RESULTS


A positive outcome of the educational program was that it contributed to a decrease in the consumption of sweetened hot beverages ( p  = 0.005) and an increase in water intake ( p  = 0.001). The nutrition education program was also successful in reducing the consumption of sweets. Children's education improved the parents' knowledge about dietary sources of fiber and the recommended fiber intake, and it contributed to the awareness that breakfast is the most important meal of the day. The program did not enhance the parents' knowledge about snacking between meals or the role of sweetened beverages in dental caries, overweight and obesity.
CONCLUSIONS


Long-term multi-stage nutrition education for children aged 3 to 6 years can be helpful in shaping families' eating habits and improving parental nutrition knowledge. However, the program was less effective in eliminating the respondents' preference for sweet-tasting foods.",2022,"The program did not enhance the parents' knowledge about snacking between meals or the role of sweetened beverages in dental caries, overweight and obesity.
","['parents of children who had completed the 7-month educational program and the parents of control group children once again completed the questionnaire', '211 children from four randomly selected kindergartens participated in the ""Colorful Eating Is Healthy Eating"" educational program that lasted 7 months', '733 parents consented to participate in the project', 'children aged 3 to 6 years', 'Healthy Eating']","['long-term nutrition education', 'nutrition education program', 'Colorful Eating', 'Long-term multi-stage nutrition education']","['consumption of sweets', 'consumption of sweetened hot beverages', 'Eating Habits', 'water intake']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}]",11.0,0.00411541,"The program did not enhance the parents' knowledge about snacking between meals or the role of sweetened beverages in dental caries, overweight and obesity.
","[{'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Kostecka', 'Affiliation': 'Faculty of Food Science and Biotechnology, University of Life Sciences in Lublin, Akademicka 15, 20950 Lublin, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph19041981']
2291,35206165,Development and Evaluation of the Course on Global Health Nursing for Indian Nursing Students.,"The purpose of this study was to develop and evaluate the effectiveness of the course on Global Health Nursing for Indian nursing students, intended to introduce the course as a selective course in the nursing curriculum.
METHODS


A quasi-experimental nonequivalent control group pre- and post-test design was carried out. The study participants were fifty final grade nursing students, considered as an experimental (n = 25) and control group (n = 25). The participants recruited by purposive sampling were fifty 4th grade nursing students (experimental 25, control 25) at St. X College of Nursing, India. The course on Global Health Nursing was developed by using the ADDIE model, and the duration of the course was about 16 h over three weeks. The course was implemented based on Gagné's instructional method. Data were collected by self-perceived scales of Global Health Nursing before and after the course, the participants' opinions, and feedback providing comments about the course.
RESULTS


The study results showed improvement in knowledge (F = 8.48;  p  < 0.001), skills (F = 96.14;  p  < 0.001), and performance on Global Health Nursing (F = 5.50;  p  < 0.001) and was statistically significant. Moreover, the participants described that they were satisfied with the quality of teaching-learning and achieved the learning goals.
CONCLUSION


The outcome of this study could be extended to the existing nursing curriculum and would be modified to formulate a standard module in the curriculum of the Indian nursing system. The study offers implications for different fields of nursing, including nursing education, research, and practice in India.",2022,The study results showed improvement in knowledge (F = 8.48;  ,"['Indian nursing students', 'participants recruited by purposive sampling were fifty 4th grade nursing students (experimental 25, control 25) at St. X College of Nursing, India', 'participants were fifty final grade nursing students, considered as an experimental (n = 25) and control group (n = 25', 'Indian Nursing Students']",[],"['quality of teaching-learning', 'Global Health Nursing', 'knowledge']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}]",[],"[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0842894,The study results showed improvement in knowledge (F = 8.48;  ,"[{'ForeName': 'Vasuki', 'Initials': 'V', 'LastName': 'Rajaguru', 'Affiliation': 'Department of Healthcare Management, Graduate School of Public Health, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'College of Nursing, Institute of Health Science, Inje University, Busan 47392, Korea.'}, {'ForeName': 'Mihae', 'Initials': 'M', 'LastName': 'Im', 'Affiliation': 'Department of Nursing, Choonhae College of Health Sciences, Ulsan 44965, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph19041978']
2292,35195012,Cost Analysis From a Randomized Comparison of Immediate Versus Delayed Angiography After Cardiac Arrest.,"Background In patients with out-of-hospital cardiac arrest without ST-segment elevation, immediate coronary angiography did not improve clinical outcomes when compared with delayed angiography in the COACT (Coronary Angiography After Cardiac Arrest) trial. Whether 1 of the 2 strategies has benefits in terms of health care resource use and costs is currently unknown. We assess the health care resource use and costs in patients with out-of-hospital cardiac arrest. Methods and Results A total of 538 patients were randomly assigned to a strategy of either immediate or delayed coronary angiography. Detailed health care resource use and cost-prices were collected from the initial hospital episode. A generalized linear model and a gamma distribution were performed. Generic quality of life was measured with the RAND-36 and collected at 12-month follow-up. Overall total mean costs were similar between both groups (EUR 33 575±19 612 versus EUR 33 880±21 044;  P =0.86). Generalized linear model: (β, 0.991; 95% CI, 0.894-1.099;  P =0.86). Mean procedural costs (coronary angiography and percutaneous coronary intervention, coronary artery bypass graft) were higher in the immediate angiography group (EUR 4384±3447 versus EUR 3028±4220;  P <0.001). Costs concerning intensive care unit and ward stay did not show any significant difference. The RAND-36 questionnaire did not differ between both groups. Conclusions The mean total costs between patients with out-of-hospital cardiac arrest randomly assigned to an immediate angiography or a delayed invasive strategy were similar during the initial hospital stay. With respect to the higher invasive procedure costs in the immediate group, a strategy awaiting neurological recovery followed by coronary angiography and planned revascularization may be considered. Registration URL: https://trialregister.nl; Unique identifier: NL4857.",2022,"Mean procedural costs (coronary angiography and percutaneous coronary intervention, coronary artery bypass graft) were higher in the immediate angiography group (EUR 4384±3447 versus EUR 3028±4220;  P <0.001).","['538 patients', 'patients with out-of-hospital cardiac arrest randomly assigned to an', 'patients with out-of-hospital cardiac arrest']","['Immediate Versus Delayed Angiography', 'immediate angiography or a delayed invasive strategy', 'delayed angiography in the COACT (Coronary Angiography', 'immediate or delayed coronary angiography']","['Mean procedural costs (coronary angiography and percutaneous coronary intervention, coronary artery bypass graft', 'RAND-36 questionnaire', 'mean total costs', 'Overall total mean costs', 'Generic quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",538.0,0.0249065,"Mean procedural costs (coronary angiography and percutaneous coronary intervention, coronary artery bypass graft) were higher in the immediate angiography group (EUR 4384±3447 versus EUR 3028±4220;  P <0.001).","[{'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Camaro', 'Affiliation': 'Department of Cardiology Radboud University Medical Center Nijmegen the Netherlands.'}, {'ForeName': 'Judith L', 'Initials': 'JL', 'LastName': 'Bonnes', 'Affiliation': 'Department of Cardiology Radboud University Medical Center Nijmegen the Netherlands.'}, {'ForeName': 'Eddy M', 'Initials': 'EM', 'LastName': 'Adang', 'Affiliation': 'Department of Health EvidenceRadboudumc Technology Center for Health Economics Nijmegen the Netherlands.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Spoormans', 'Affiliation': 'Department of Cardiology Amsterdam University Medical Centerlocation VUmc Amsterdam the Netherlands.'}, {'ForeName': 'Gladys N', 'Initials': 'GN', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology Amsterdam University Medical Centerlocation VUmc Amsterdam the Netherlands.'}, {'ForeName': 'Nina W', 'Initials': 'NW', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Cardiology Amsterdam University Medical Centerlocation VUmc Amsterdam the Netherlands.'}, {'ForeName': 'Lucia S', 'Initials': 'LS', 'LastName': 'Jewbali', 'Affiliation': 'Department of Cardiology and Intensive Care Medicine Erasmus Medical Centre Rotterdam the Netherlands.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Dubois', 'Affiliation': 'Department of Cardiology and Intensive Care Medicine Erasmus Medical Centre Rotterdam the Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Meuwissen', 'Affiliation': 'Department of Cardiology Amphia Hospital Breda the Netherlands.'}, {'ForeName': 'Tom A', 'Initials': 'TA', 'LastName': 'Rijpstra', 'Affiliation': 'Department of Intensive Care Medicine Amphia Hospital Breda the Netherlands.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Bosker', 'Affiliation': 'Department of Cardiology Rijnstate Hospital Arnhem the Netherlands.'}, {'ForeName': 'Michiel J', 'Initials': 'MJ', 'LastName': 'Blans', 'Affiliation': 'Department of Intensive Care Medicine Rijnstate Hospital Arnhem the Netherlands.'}, {'ForeName': 'Gabe B', 'Initials': 'GB', 'LastName': 'Bleeker', 'Affiliation': 'Department of Cardiology HAGA Hospital Den Haag the Netherlands.'}, {'ForeName': 'Rémon', 'Initials': 'R', 'LastName': 'Baak', 'Affiliation': 'Department of Intensive Care Medicine HAGA Hospital Den Haag the Netherlands.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Vlachojannis', 'Affiliation': 'Department of Cardiology Maasstad Hospital Rotterdam and University Medical Centre Utrecht Utrecht the Netherlands.'}, {'ForeName': 'Bob J', 'Initials': 'BJ', 'LastName': 'Eikemans', 'Affiliation': 'Department of Intensive Care Medicine Maasstad Hospital Rotterdam the Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'van der Harst', 'Affiliation': 'Department of Cardiology University Medical Center Groningen and University Medical Centre Utrecht Groningen and Utrecht the Netherlands.'}, {'ForeName': 'Iwan C', 'Initials': 'IC', 'LastName': 'van der Horst', 'Affiliation': 'Department of Critical Care University Medical Center Groningen and Maastricht University Medical Center+ Groningen and Maastricht the Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Voskuil', 'Affiliation': 'Department of Cardiology University Medical Center Utrecht Utrecht the Netherlands.'}, {'ForeName': 'Joris J', 'Initials': 'JJ', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Intensive Care Medicine University Medical Center Utrecht Utrecht the Netherlands.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Beishuizen', 'Affiliation': 'Department of Intensive Care Medicine Medisch Spectrum Twente Enschede The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Stoel', 'Affiliation': 'Department of Cardiology Medisch Spectrum Twente Enschede The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care Medicine Radboud University Medical Center Nijmegen the Netherlands.'}, {'ForeName': 'José P', 'Initials': 'JP', 'LastName': 'Henriques', 'Affiliation': 'Department of Cardiology Amsterdam University Medical Centerlocation AMC Amsterdam the Netherlands.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Vlaar', 'Affiliation': 'Department of Intensive Care Medicine Amsterdam University Medical Centerlocation AMC Amsterdam the Netherlands.'}, {'ForeName': 'Maarten A', 'Initials': 'MA', 'LastName': 'Vink', 'Affiliation': 'Department of Cardiology OLVG Amsterdam the Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'van den Bogaard', 'Affiliation': 'Department of Intensive Care Medicine OLVG Amsterdam the Netherlands.'}, {'ForeName': 'Ton A', 'Initials': 'TA', 'LastName': 'Heestermans', 'Affiliation': 'Department of Cardiology Noord West Ziekenhuisgroep Alkmaar the Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'de Ruijter', 'Affiliation': 'Department of Intensive Care Medicine Noord West Ziekenhuisgroep Alkmaar the Netherlands.'}, {'ForeName': 'Thijs S', 'Initials': 'TS', 'LastName': 'Delnoij', 'Affiliation': 'Department of Intensive Care Medicine Maastricht University Medical Center+ Maastricht the Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'Crijns', 'Affiliation': 'Department of Cardiology Maastricht University Medical Center+ Maastricht the Netherlands.'}, {'ForeName': 'Gillian A', 'Initials': 'GA', 'LastName': 'Jessurun', 'Affiliation': 'Department of Cardiology Scheper Hospital Emmen the Netherlands.'}, {'ForeName': 'Pranobe V', 'Initials': 'PV', 'LastName': 'Oemrawsingh', 'Affiliation': 'Department of Cardiology Haaglanden Medical Center Den Haag the Netherlands.'}, {'ForeName': 'Marcel T', 'Initials': 'MT', 'LastName': 'Gosselink', 'Affiliation': 'Department of Cardiology Isala Hospital Zwolle the Netherlands.'}, {'ForeName': 'Koos', 'Initials': 'K', 'LastName': 'Plomp', 'Affiliation': 'Department of Cardiology Tergooi Hospital Blaricum the Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Magro', 'Affiliation': 'Department of Cardiology Elisabeth-Tweesteden Hospital Tilburg the Netherlands.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Elbers', 'Affiliation': 'Department of Intensive Care Medicine Amsterdam University Medical Centerlocation VUmc Amsterdam the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Data Science Amsterdam University Amsterdam the Netherlands.'}, {'ForeName': 'Jorrit S', 'Initials': 'JS', 'LastName': 'Lemkes', 'Affiliation': 'Department of Cardiology Amsterdam University Medical Centerlocation VUmc Amsterdam the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology Radboud University Medical Center Nijmegen the Netherlands.'}]",Journal of the American Heart Association,['10.1161/JAHA.121.022238']
2293,35194918,The anorectal defaecation reflex: a prospective intervention study.,"AIM


Our hypothesis is that there may be a neural pathway with sensory afferent neurons in the anal canal that leads to rectal contraction to assist defaecation. We aimed to compare rectal motility between healthy participants with or without anal anaesthesia.
METHOD


This prospective intervention study consisted of two test sessions: a baseline session followed by an identical second session. During each session we performed the anal electrosensitivity test, the rectoanal inhibitory reflex test and rapid phasic barostat distensions. Prior to the second session, participants were randomly assigned to receive either a local anal anaesthetic or a placebo.
RESULTS


We included 23 healthy participants aged 21.1 ± 0.5 years, 13 of whom received an anal anaesthetic and 10 a placebo. All participants showed a transient rectal contraction during the first test session, which decreased significantly after anal anaesthesia (18.6 ml vs. 4.9 ml, p = 0.019). The maximum rectal contraction was comparable to the baseline results in the placebo group. Furthermore, the electrosensitivity at the highest centimetre of the anal canal correlated with the maximum rectal contraction (r = -0.452, p = 0.045).
CONCLUSION


All healthy study participants display an involuntary, reproducible rectal reflex contraction that appears to be innervated by afferent nerves in the proximal anal canal. The rectal reflex contraction appears to play a role in defaecation and we therefore refer to this phenomenon as the anorectal defaecation reflex. Knowledge of the anorectal defaecation reflex may have consequences for the diagnostics and treatment of constipation.",2022,"All participants showed a transient rectal contraction during the first test session, which decreased significantly after anal anaesthesia (18.6 mL versus 4.9 mL, p = 0.019).","['23 healthy participants aged 21.1 ± 0.5 years, 13 of whom received an anal anaesthetic and 10 received a', 'healthy participants with or without anal anaesthesia']","['placebo', 'local anal anaesthetic or a placebo']","['maximal rectal contraction', 'rectal motility', 'transient rectal contraction', 'Maximal rectal contraction']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0040704', 'cui_str': 'Transients'}]",23.0,0.13317,"All participants showed a transient rectal contraction during the first test session, which decreased significantly after anal anaesthesia (18.6 mL versus 4.9 mL, p = 0.019).","[{'ForeName': 'Sanne J', 'Initials': 'SJ', 'LastName': 'Verkuijl', 'Affiliation': 'Department of Surgery, Anorectal Physiology Laboratory, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Trzpis', 'Affiliation': 'Department of Surgery, Anorectal Physiology Laboratory, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Paul M A', 'Initials': 'PMA', 'LastName': 'Broens', 'Affiliation': 'Department of Surgery, Anorectal Physiology Laboratory, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.16101']
2294,35196304,Variations in clot phenotype following injury: The MA-R ratio and fragile clots.,"INTRODUCTION


Trauma-induced coagulopathy is a continuum ranging from hypercoagulable to hypercoagulable phenotypes. In single-center studies, the maximum amplitude (MA) to r-time (R) (MA-R) ratio has identified a phenotype of injured patients with high mortality risk. The purpose of this study was to determine the relationship between MA-R and mortality using multicenter data and to investigate fibrinogen consumption in the development of this specific coagulopathy phenotype.
METHODS


Using the Pragmatic Randomized Optimal Platelet and Plasma Ratios data set, patients were divided into blunt and penetrating injury cohorts. MA was divided by R time from admission thromboelastogram to calculate MA-R. MA-R was used to assess odds of early and late mortality using multivariable models. Multivariable models were used to assess thrombogram values in both cohorts. Refinement of the MA-R cut point was performed with Youden index. Repeat multivariable analysis was performed with a binary CRITICAL and NORMAL MA-R.
RESULTS


In initial analysis, MA-R quartiles were not associated with mortality in the penetrating cohort. In the blunt cohort, there was an association between low MA-R and early and late mortality. A refined cut point of 11 was identified (CRITICAL: MA-R, ≤11; NORMAL: MA-R, >11). CRITICAL MA-R was associated with mortality in both penetrating and blunt subgroups. In further injury subgroup analysis, CRITICAL patients had significantly decreased fibrinogen levels in the blunt subgroup only. In both blunt and penetrating injury, there was no difference in time to initiation of thrombin burst (lagtime). However, both endogenous thrombin potential and peak thrombin levels were significantly lower in CRITICAL patients.
CONCLUSIONS


MA-R identifies a trauma-induced coagulopathy phenotype characterized in blunt injury by impaired thrombin generation that is associated with early and late mortality. The endotheliopathy and tissue factor release likely plays a role in the cascade of impaired thrombin burst, possible early fibrinogen consumption and the weaker clot identified by MA-R.
LEVEL OF EVIDENCE


Therapeutic/care management, level II.",2022,"In both blunt and penetrating injury, there was no difference in time to initiation of thrombin burst (lagtime).",['patients were divided into blunt and penetrating injury cohorts'],[],"['fibrinogen levels', 'endogenous thrombin potential and peak thrombin levels', 'time to initiation of thrombin burst (lagtime', 'low MA-R and early and late mortality', 'maximum amplitude (MA) to r-time (R) (MA-R) ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0043254', 'cui_str': 'Penetrating wound'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C0337428', 'cui_str': 'Fibrinogen assay'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0509482,"In both blunt and penetrating injury, there was no difference in time to initiation of thrombin burst (lagtime).","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Harrington', 'Affiliation': 'From the Department of Surgery, University of Wisconsin School of Medicine and Public Health (J.H., B.L.Z., S.A.S), Madison, Wisconsin; Department of Surgery, University of Texas Health Science Center at Houston (E.E.F., C.E.W.), Houston, Texas; and Department of Surgery, University of Alabama at Birmingham (J.B.H.), Birmingham, Alabama.'}, {'ForeName': 'Ben L', 'Initials': 'BL', 'LastName': 'Zarzaur', 'Affiliation': ''}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': ''}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': ''}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Savage', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000003442']
2295,35200298,"""The Best Laid Plans"": Do Individual Differences in Planfulness Moderate Effects of Implementation Intention Interventions?","While there is good evidence supporting the positive effect of planning strategies like implementation intentions on the relationship between intention and behavior, there is less evidence on the moderating role of individual differences in planning capacity on this effect. This study aimed to examine the role of individual differences in planfulness on the effect of planning strategies on the intention-behavior gap. Specifically, this study investigated the influence of planfulness on the effectiveness of implementation intentions on goal-directed behavior using an experimental design. Undergraduate university students ( N  = 142) with high and low levels of planfulness based on a priori scores on a planfulness measure were randomized to either a planning (implementation intention) or familiarization (control) condition prior to completing a computerized go no-go task. We predicted that individuals reporting low levels of planfulness would be more effective in executing goal-directed behavior when prompted to form an implementation intention compared to individuals who do not receive a prompt. Additionally, we predicted that individuals reporting high planfulness would be equally effective in enacting goal-directed behaviour regardless of whether they formed an implementation intention. The results revealed no main or interaction effects of implementation intention manipulation and planfulness on task reaction times. The current results do not provide support for the moderating effect of planfulness on the implementation effect. The findings of this study were inconsistent with previous literature. This research has implications for the effectiveness of implementation intentions, as well as opportunities for further replication in a novel research area.",2022,The results revealed no main or interaction effects of implementation intention manipulation and planfulness on task reaction times.,['Undergraduate university students ( N  = 142) with high and low levels of planfulness based on a priori scores on a planfulness measure'],['planning (implementation intention) or familiarization (control) condition prior to completing a computerized go no-go task'],['task reaction times'],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}]",142.0,0.0217564,The results revealed no main or interaction effects of implementation intention manipulation and planfulness on task reaction times.,"[{'ForeName': 'Sabryna V', 'Initials': 'SV', 'LastName': 'Sas', 'Affiliation': 'School of Applied Psychology, Mt Gravatt Campus, Griffith University, 176 Messines Ridge Road, Mt Gravatt, QLD 4122, Australia.'}, {'ForeName': 'Kyra', 'Initials': 'K', 'LastName': 'Hamilton', 'Affiliation': 'School of Applied Psychology, Mt Gravatt Campus, Griffith University, 176 Messines Ridge Road, Mt Gravatt, QLD 4122, Australia.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Hagger', 'Affiliation': 'School of Applied Psychology, Mt Gravatt Campus, Griffith University, 176 Messines Ridge Road, Mt Gravatt, QLD 4122, Australia.'}]","Behavioral sciences (Basel, Switzerland)",['10.3390/bs12020047']
2296,35200551,Gadoxetic Acid-Based MRI for Decision-Making in Hepatocellular Carcinoma Employing Perfusion Criteria Only-A Post Hoc Analysis from the SORAMIC Trial Diagnostic Cohort.,"The value of gadoxetic acid in the diagnosis of hepatocellular carcinoma (HCC), based on perfusion criteria, is under dispute. This post-hoc analysis of the prospective, phase II, randomized, controlled SORAMIC study compared the accuracy of gadoxetic acid-enhanced dynamic magnetic resonance imaging (MRI) (arterial, portovenous, and venous phase only) versus contrast-enhanced computed tomography (CT) for stratifying patients with HCC to curative ablation or palliative treatment. Two reader groups (radiologists, R1 and R2) performed blind reads of CT and gadoxetic acid-enhanced MRI (contrast dynamics only). A truth panel, with access to clinical and imaging follow-up data, served as reference. Primary endpoint was non-inferiority (margin: 5% points) of MRI vs. CT (lower 95% confidence interval [CI] > 0.75) in a first step and superiority (complete 95% CI > 1) in a second step. The intent-to-treat population comprised 538 patients. Accuracy of treatment decisions was 73.4% and 70.8% for CT (R1 and R2, respectively) and 75.1% and 70.3% for gadoxetic acid-enhanced dynamic MRI. Non-inferiority but not superiority of gadoxetic acid-enhanced dynamic MRI versus CT was demonstrated (odds ratio 1.01; CI 0.97-1.05). Despite a theoretical disadvantage in wash-out depiction, gadoxetic acid-enhanced dynamic MRI is non-inferior to CT in accuracy of treatment decisions for curative ablation versus palliative strategies. This outcome was not subject to the use of additional MR standard sequences.",2022,"Accuracy of treatment decisions was 73.4% and 70.8% for CT (R1 and R2, respectively) and 75.1% and 70.3% for gadoxetic acid-enhanced dynamic MRI. Non-inferiority but not superiority of gadoxetic acid-enhanced dynamic MRI versus CT was demonstrated (odds ratio 1.01; CI 0.97-1.05).","['Hepatocellular Carcinoma Employing Perfusion Criteria', 'stratifying patients with HCC to curative ablation or palliative treatment']","['gadoxetic acid-enhanced dynamic magnetic resonance imaging (MRI) (arterial, portovenous, and venous phase only) versus contrast-enhanced computed tomography (CT', 'Gadoxetic Acid-Based MRI', 'gadoxetic acid']",['non-inferiority'],"[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]","[{'cui': 'C3489483', 'cui_str': 'gadoxetic acid'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}]",,0.148925,"Accuracy of treatment decisions was 73.4% and 70.8% for CT (R1 and R2, respectively) and 75.1% and 70.3% for gadoxetic acid-enhanced dynamic MRI. Non-inferiority but not superiority of gadoxetic acid-enhanced dynamic MRI versus CT was demonstrated (odds ratio 1.01; CI 0.97-1.05).","[{'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Seidensticker', 'Affiliation': 'Department of Radiology, Ludwig-Maximilians-University Munich, 81377 München, Germany.'}, {'ForeName': 'Ingo G', 'Initials': 'IG', 'LastName': 'Steffen', 'Affiliation': 'Department of Radiology, Ludwig-Maximilians-University Munich, 81377 München, Germany.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Bargellini', 'Affiliation': 'Department of Interventional Radiology, Pisa University Hospital, 56100 Pisa, Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berg', 'Affiliation': 'Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Benito', 'Affiliation': 'Department of Radiology, Clínica Universidad de Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Gebauer', 'Affiliation': 'Department of Radiology, Charité-Universitätsmedizin Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Iezzi', 'Affiliation': 'Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Radiologia, 00168 Rome, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Loewe', 'Affiliation': 'Section of Cardiovascular and Interventional Radiology, Department of Bioimaging and Image-Guided Therapy, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Musturay', 'Initials': 'M', 'LastName': 'Karçaaltincaba', 'Affiliation': 'Department of Radiology, Hacettepe University School of Medicine, Ankara 06230, Turkey.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Pech', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University of Magdeburg, 39120 Magdeburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sengel', 'Affiliation': 'Radiologie Interventionnelle Vasculaire et Percutanée, CHU de Grenoble, 38700 Grenoble, France.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'van Delden', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Academic Medical Center, University of Amsterdam, 1012 WX Amsterdam, The Netherlands.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vandecaveye', 'Affiliation': 'Department of Radiology, University Hospitals Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Christoph J', 'Initials': 'CJ', 'LastName': 'Zech', 'Affiliation': 'Radiology and Nuclear Medicine, University Hospital Basel, University of Basel, 4031 Basel, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Ricke', 'Affiliation': 'Department of Radiology, Ludwig-Maximilians-University Munich, 81377 München, Germany.'}]","Current oncology (Toronto, Ont.)",['10.3390/curroncol29020051']
2297,35200521,The Acute Effects of Breakfast Drinks with Varying Protein and Energy Contents on Appetite and Free-Living Energy Intake in UK Older Adults.,"Proposed strategies for preventing protein deficiencies in older patients include increasing protein intake at breakfast. However, protein is highly satiating and the effects of very high protein intakes at breakfast on subsequent appetite and free-living energy intake (EI) in older adults are unclear. This study compared the acute effects of two breakfast drinks varying in protein and energy contents on appetite and free-living EI in healthy older adults using a randomized 2 × 2 crossover design. Participants ( n  = 48 (20 men, 28 women); mean ± SD age: 69 ± 3 years; BMI: 22.2 ± 2.0 kg·m -2 ; fat-free mass: 45.5 ± 8.0 kg) consumed two drinks for breakfast (high-protein (30.4 ± 5.3 g), low-energy (211.2 ± 37.1 kcal) content (HPLE) and very high-protein (61.8 ± 9.9 g), fed to energy requirements (428.0 ± 68.9 kcal) (VHPER)) one week apart. Appetite perceptions were assessed for 3 h post-drink and free-living EI was measured for the remainder of the day. Appetite was lower in VHPER than HPLE from 30 min onwards ( p  < 0.01). Free-living energy and protein intake did not differ between conditions ( p  = 0.814). However, 24 h EI (breakfast drink intake + free-living intake) was greater in VHPER than HPLE (1937 ± 568 kcal vs. 1705 ± 490 kcal;  p  = 0.001), as was 24 h protein intake (123.0 ± 26.0 g vs. 88.6 ± 20.9 g;  p  < 0.001). Consuming a very high-protein breakfast drink acutely suppressed appetite more than a low-energy, high-protein drink in older adults, though free-living EI was unaffected. The long-term effects of adopting such a breakfast strategy in older adults at high risk of energy and protein malnutrition warrants exploration.",2022,Free-living energy and protein intake did not differ between conditions ( p  = 0.814).,"['older adults at high risk of energy and protein malnutrition warrants exploration', 'UK Older Adults', 'Participants ( n  = 48 (20 men, 28 women); mean ± SD age: 69 ± 3 years; BMI: 22.2 ± 2.0 kg·m -2 ; fat-free mass: 45.5 ± 8.0 kg) consumed two drinks for breakfast (high-protein (30.4 ± 5.3 g), low-energy (211.2 ± 37.1 kcal) content (HPLE) and very high-protein (61.8 ± 9.9 g), fed to energy requirements (428.0 ± 68.9 kcal) (VHPER)) one week apart', 'older patients', 'older adults', 'healthy older adults']","['Breakfast Drinks with Varying Protein and Energy Contents', 'breakfast drinks varying in protein and energy contents']","['Appetite perceptions', 'Appetite and Free-Living Energy Intake', '24 h EI (breakfast drink intake + free-living intake', 'Appetite', 'Free-living energy and protein intake']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0022806', 'cui_str': 'Kwashiorkor'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0489460', 'cui_str': 'Energy requirement'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0556158', 'cui_str': 'Drink intake'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",,0.0478035,Free-living energy and protein intake did not differ between conditions ( p  = 0.814).,"[{'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Crabtree', 'Affiliation': 'Division of Biomedical Sciences, University of the Highlands and Islands, Old Perth Road, Inverness IV2 3JH, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Holliday', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne NE4 5PL, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Buosi', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill Road, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Fyfe', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill Road, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'Graham W', 'Initials': 'GW', 'LastName': 'Horgan', 'Affiliation': 'Biomathematics and Statistics Scotland, Foresterhill Road, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Johnstone', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill Road, Aberdeen AB25 2ZD, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': 'On Behalf Of The Full Health-Study Group', 'Affiliation': ''}]","Geriatrics (Basel, Switzerland)",['10.3390/geriatrics7010016']
2298,35200402,Effect of Short-Term Deep-Pressure Portable Seat on Behavioral and Biological Stress in Children with Autism Spectrum Disorders: A Pilot Study.,"Children with autism spectrum disorder (ASD) have challenging behaviors, which are associated with difficulties in parenting. Deep pressure is a therapeutic modality in occupational therapy, and it was reported to produce a calming effect. This study aimed to determine whether the short-term use of an autism hug machine portable seat (AHMPS) improves behavioral and neurobiological stress in children with ASD, and to determine whether AHMPS with an inflatable wrap or manual pull is more effective. This study enrolled children with ASD who were administered with the inflatable wrap (group I) and manual pull (group II) for 20 min twice a week for 3 weeks. Conners' Parent Rating Scale-48 (CPRS-48) was used to rate behavioral improvements, and galvanic skin response (GSR) was used to measure sympathetic stress response. A total of 20 children with ASD (14 boys and 6 girls; aged 7-13 years) were included. CPRS-48 presented conduct problems: behavior was significantly decreased in the inflatable group ( p  = 0.007) compared to the manual pull group. The GSR captured a significant reduction in sympathetic response ( p  = 0.01) only in group I. Neurobiological stress was reduced in children who were wearing the AHMPS inflatable wrap; therefore, AHMPS inflatable wrap is an effective method to reduce emotional arousal.",2022,CPRS-48 presented conduct problems: behavior was significantly decreased in the inflatable group ( p  = 0.007) compared to the manual pull group.,"['Children with Autism', 'children with ASD', 'enrolled children with ASD', 'Children with autism spectrum disorder (ASD', '20 children with ASD (14 boys and 6 girls; aged 7-13 years', 'Spectrum Disorders']","['autism hug machine portable seat (AHMPS', 'Short-Term Deep-Pressure Portable Seat', 'manual pull']","['emotional arousal', 'behavioral and neurobiological stress', 'sympathetic response', 'Behavioral and Biological Stress', 'rate behavioral improvements, and galvanic skin response (GSR', 'sympathetic stress response']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C2350026', 'cui_str': 'Biological Stress'}, {'cui': 'C0016989', 'cui_str': 'Galvanic skin response'}]",20.0,0.00870356,CPRS-48 presented conduct problems: behavior was significantly decreased in the inflatable group ( p  = 0.007) compared to the manual pull group.,"[{'ForeName': 'Ilham Yustar', 'Initials': 'IY', 'LastName': 'Afif', 'Affiliation': 'Undip Biomechanics Engineering & Research Centre (UBM-ERC), Diponegoro University, Semarang 50275, Indonesia.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Farkhan', 'Affiliation': 'Department of Mechanical Engineering, Faculty of Engineering, Diponegoro University, Semarang 50275, Indonesia.'}, {'ForeName': 'Ojo', 'Initials': 'O', 'LastName': 'Kurdi', 'Affiliation': 'Department of Mechanical Engineering, Faculty of Engineering, Diponegoro University, Semarang 50275, Indonesia.'}, {'ForeName': 'Mohamad Izzur', 'Initials': 'MI', 'LastName': 'Maula', 'Affiliation': 'Undip Biomechanics Engineering & Research Centre (UBM-ERC), Diponegoro University, Semarang 50275, Indonesia.'}, {'ForeName': 'Muhammad Imam', 'Initials': 'MI', 'LastName': 'Ammarullah', 'Affiliation': 'Undip Biomechanics Engineering & Research Centre (UBM-ERC), Diponegoro University, Semarang 50275, Indonesia.'}, {'ForeName': 'Budi', 'Initials': 'B', 'LastName': 'Setiyana', 'Affiliation': 'Department of Mechanical Engineering, Faculty of Engineering, Diponegoro University, Semarang 50275, Indonesia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jamari', 'Affiliation': 'Undip Biomechanics Engineering & Research Centre (UBM-ERC), Diponegoro University, Semarang 50275, Indonesia.'}, {'ForeName': 'Tri Indah', 'Initials': 'TI', 'LastName': 'Winarni', 'Affiliation': 'Undip Biomechanics Engineering & Research Centre (UBM-ERC), Diponegoro University, Semarang 50275, Indonesia.'}]","Bioengineering (Basel, Switzerland)",['10.3390/bioengineering9020048']
2299,35200634,A  Dunaliella salina  Extract Counteracts Skin Aging under Intense Solar Irradiation Thanks to Its Antiglycation and Anti-Inflammatory Properties.,"Glycation, and the resulting buildup of advanced glycation end products (AGEs), is recognized as a key driver of cumulative skin damage and skin aging.  Dunaliella salina  is a halophile microalga adapted to intense solar radiation through the production of carotenoids. We present a natural supercritical CO 2  extract of  Dunaliella salina  rich in the colorless carotenoids phytoene and phytofluene. The extract exhibited antiglycation and anti-inflammatory activities in ex vivo testing, showing strongly reduced formation of N-ε-carboxy-methyl-lysine with exposure to methylglyoxal, reduced AGE receptor levels, and significantly reduced interleukins 6 and 8. In a placebo-controlled clinical study under intense solar exposure, the extract significantly reduced the skin's glycation scores and its sensitivity to histamine; key skin aging parameters were also significantly improved vs. placebo, including wrinkle counts and spots. These results demonstrate the value of this  Dunaliella salina  extract, rich in colorless carotenoids, as an antiglycative, anti-inflammatory, and antiaging active ingredient, including in high-irradiation contexts.",2022,"In a placebo-controlled clinical study under intense solar exposure, the extract significantly reduced the skin's glycation scores and its sensitivity to histamine; key skin aging parameters were also significantly improved vs. placebo, including wrinkle counts and spots.",[],['placebo'],"[""skin's glycation scores""]",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0547216,"In a placebo-controlled clinical study under intense solar exposure, the extract significantly reduced the skin's glycation scores and its sensitivity to histamine; key skin aging parameters were also significantly improved vs. placebo, including wrinkle counts and spots.","[{'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Havas', 'Affiliation': 'International Flavors & Fragrances-Lucas Meyer Cosmetics, Faran 4, Yavne 8122503, Israel.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Krispin', 'Affiliation': 'International Flavors & Fragrances-Lucas Meyer Cosmetics, Faran 4, Yavne 8122503, Israel.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'International Flavors & Fragrances-Lucas Meyer Cosmetics, Faran 4, Yavne 8122503, Israel.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Loing', 'Affiliation': 'International Flavors & Fragrances, 521 West 57th Street, New York, NY 10019, USA.'}, {'ForeName': 'Morgane', 'Initials': 'M', 'LastName': 'Farge', 'Affiliation': ""International Flavors & Fragrances-Lucas Meyer Cosmetics, 195 Route d'Espagne, 31 036 Toulouse, France.""}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Suere', 'Affiliation': ""International Flavors & Fragrances-Lucas Meyer Cosmetics, 195 Route d'Espagne, 31 036 Toulouse, France.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Attia-Vigneau', 'Affiliation': ""International Flavors & Fragrances-Lucas Meyer Cosmetics, 195 Route d'Espagne, 31 036 Toulouse, France.""}]",Marine drugs,['10.3390/md20020104']
2300,35200601,The Prognostic Effect of Multidisciplinary Team Intervention in Patients with Advanced Gastric Cancer.,"BACKGROUND


The effect of multidisciplinary team intervention (MDT) on the prognosis of advanced gastric cancer (GC) is still controversial. This study aims to analyze the effect of MDTs on the overall survival time of advanced gastric cancer patients.
METHODS


Patients with advanced GC who underwent surgical treatment between 2007 and 2014 were included in the study. They were divided into two groups; the MDT group received MDT treatment and the non-MDT group received conventional treatment. The Kaplan-Meier method was used to compare the overall survival (OS) of the two groups. The prognostic factors of advanced GC were evaluated by multivariate Cox regression analysis.
RESULTS


394 patients were included in our study. Kaplan-Meier survival analysis showed that the prognosis of advanced GC patients with who underwent MDT intervention was better than those without (3-year OS of 55.6% vs. 46.1%,  p  = 0.005), Multivariate analysis indicated that MDT intervention could reduce mortality (HR = 0.493,  p  < 0.001).
CONCLUSIONS


MDT intervention is an effective measure that improves the survival of patients with advanced GC.",2022,"Kaplan-Meier survival analysis showed that the prognosis of advanced GC patients with who underwent MDT intervention was better than those without (3-year OS of 55.6% vs. 46.1%,  p  = 0.005), Multivariate analysis indicated that MDT intervention could reduce mortality (HR = 0.493,  p  < 0.001).
","['patients with advanced GC', 'Patients with advanced GC who underwent surgical treatment between 2007 and 2014 were included in the study', 'Patients with Advanced Gastric Cancer', '394 patients were included in our study', 'advanced gastric cancer patients', 'advanced gastric cancer (GC']","['multidisciplinary team intervention (MDT', 'MDTs', 'Multidisciplinary Team Intervention', 'MDT intervention', 'MDT treatment and the non-MDT group received conventional treatment']","['overall survival time', 'reduce mortality', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",394.0,0.0446061,"Kaplan-Meier survival analysis showed that the prognosis of advanced GC patients with who underwent MDT intervention was better than those without (3-year OS of 55.6% vs. 46.1%,  p  = 0.005), Multivariate analysis indicated that MDT intervention could reduce mortality (HR = 0.493,  p  < 0.001).
","[{'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Xiang', 'Affiliation': 'Digestive Disease Center, Seventh Affiliated Hospital of Sun Yat-Sen University, Shenzhen 518107, China.'}, {'ForeName': 'Cun-Can', 'Initials': 'CC', 'LastName': 'Deng', 'Affiliation': 'Digestive Disease Center, Seventh Affiliated Hospital of Sun Yat-Sen University, Shenzhen 518107, China.'}, {'ForeName': 'Han-Yuan', 'Initials': 'HY', 'LastName': 'Liu', 'Affiliation': 'Digestive Disease Center, Seventh Affiliated Hospital of Sun Yat-Sen University, Shenzhen 518107, China.'}, {'ForeName': 'Zi-Chong', 'Initials': 'ZC', 'LastName': 'Kuo', 'Affiliation': 'Digestive Disease Center, Seventh Affiliated Hospital of Sun Yat-Sen University, Shenzhen 518107, China.'}, {'ForeName': 'Chang-Hua', 'Initials': 'CH', 'LastName': 'Zhang', 'Affiliation': 'Digestive Disease Center, Seventh Affiliated Hospital of Sun Yat-Sen University, Shenzhen 518107, China.'}, {'ForeName': 'Yu-Long', 'Initials': 'YL', 'LastName': 'He', 'Affiliation': 'Digestive Disease Center, Seventh Affiliated Hospital of Sun Yat-Sen University, Shenzhen 518107, China.'}]","Current oncology (Toronto, Ont.)",['10.3390/curroncol29020102']
2301,35201925,"Motivational Interviewing, Readiness for Change, Walking, and Functional Ability in Older Adults.","Regular exercise in older adults can slow the physical, psychological, and functional decline that is associated with aging. Understanding what may contribute to the initiation and adherence of exercise within the older adult population might help identify interventions that would successfully increase physical activity. The purpose of the current study was to determine if motivational interviewing would increase readiness for change, daily steps, and functional ability among older adult participants. The Senior Fitness Test (SFT) and pedometers were used to assess functional ability and daily steps within two groups of older adults. All participants who completed the 8-week study, on average, demonstrated an increase in daily steps as well as overall fitness. Posttest analyses revealed that the outcome for the intervention group did not exceed the control group, with the exception of the 8-foot up-and-go test, a test within the SFT that measures agility and dynamic balance ( p  = 0.035). One-on-one, individualized socialization sessions may have contributed to the overall improvement noted in both groups. [ Journal of Gerontological Nursing, 48 (3), 23-29.].",2022,"All participants who completed the 8-week study, on average, demonstrated an increase in daily steps as well as overall fitness.","['older adults', 'Older Adults', 'older adult participants']","['motivational interviewing', 'Regular exercise']","['measures agility and dynamic balance', 'Motivational Interviewing, Readiness for Change, Walking, and Functional Ability']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.0643727,"All participants who completed the 8-week study, on average, demonstrated an increase in daily steps as well as overall fitness.","[{'ForeName': 'Erin T', 'Initials': 'ET', 'LastName': 'Lamoureux', 'Affiliation': ''}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Jacelon', 'Affiliation': ''}]",Journal of gerontological nursing,['10.3928/00989134-20220209-04']
2302,35201924,"Improving Sleep Quality in Older Adults: Foot Reflexology or Warm Footbath? A Single-Blind, 6-Week Intervention, Two Group, Randomized Comparative Study.","The current study aimed to compare the effects of foot reflexology and warm foot-bath on improving sleep quality in older adults. Participants were randomized to the foot reflexology group ( n  = 50) or warm footbath group ( n  = 50). Data were collected using a Descriptive Information Form and the Pittsburgh Sleep Quality Index (PSQI). Foot reflexology was applied 30 minutes twice per week for 6 weeks. Warm foot-bath was applied 1 hour before bedtime every evening for 6 weeks. Comparison of mean total scores from the PSQI before and after reflexology indicated that mean postintervention total scores decreased significantly compared to preintervention scores ( p  < 0.05). Comparison of PSQI mean total scores before and after warm footbath indicated that mean postintervention total scores decreased significantly compared to preintervention scores ( p  < 0.05). Comparison of PSQI mean scores of the reflexology and warm footbath groups showed no significant difference between groups in terms of the variance in mean scores ( p  > 0.05). According to current findings, both interventions improved sleep quality in older adults. [ Journal of Gerontological Nursing, 48 (3), 17-22.].",2022,Comparison of PSQI mean scores of the reflexology and warm footbath groups showed no significant difference between groups in terms of the variance in mean scores ( p  > 0.05).,"['older adults', 'Older Adults']","['foot reflexology and warm foot-bath', 'foot reflexology group ( n  = 50) or warm footbath group']","['sleep quality', 'mean postintervention total scores', 'PSQI mean scores', 'mean scores', 'mean total scores', 'PSQI mean total scores', 'Pittsburgh Sleep Quality Index (PSQI', 'Sleep Quality']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0424743', 'cui_str': 'Warm feet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",,0.0196832,Comparison of PSQI mean scores of the reflexology and warm footbath groups showed no significant difference between groups in terms of the variance in mean scores ( p  > 0.05).,"[{'ForeName': 'Şefika Dilek', 'Initials': 'ŞD', 'LastName': 'Güven', 'Affiliation': ''}]",Journal of gerontological nursing,['10.3928/00989134-20220209-03']
2303,35205002,"Total Intravenous Anesthesia with Ketofol versus Combination of Ketofol and Lidocaine for Short-Term Anesthesia in Pediatric Patients; Double Blind, Randomized Clinical Trial of Effects on Recovery.","BACKGROUND


Ketofol admixture has been proposed to be useful for sedation and general anesthesia. The beneficial effect of the combination of ketofol with lidocaine may be a shortened time of anesthesia and recovery period. This study aimed to establish the effect of total intravenous anesthesia (TIVA) with ketofol and ketofol with lidocaine on recovery in children.
METHODS


Two hundred children from the ages of 1-12 years who underwent short surgical procedures were randomly allocated into two groups. Propofol mixtures (ketofol) were prepared for group l. A ratio of 1:4 of ketofol was used for induction and for the maintenance of anesthesia a ratio of was used 1:7. For the induction and maintenance of anesthesia ketofol with lidocaine (lidoketofol) was used in group II. The McFarlan infusion regimen was used with reduction. The extubating time, anesthesia duration and the length of stay in the post-anesthesia care unit (PACU) were recorded.
RESULTS


Extubation time showed to be considerably shorter in the lidoketofol group than in the ketofol group (120 s versus 240 s;  p  < 0.00001). The anesthesia duration was also significantly shorter in the lidoketofol group (35 min vs. 50 min;  p  < 0.00001). The lidoketofol group showed to have a lower length of stay in the post-anesthesia care unit (PACU) than the ketofol group (20 min vs. 35 min;  p  < 0.00001). The lidoketofol group showed lower fentanyl consumption per kg (2.1 µg per kg vs. 2.3 µg per kg;  p  < 0.056) and lower propofol consumption (6.6 mg per kg vs. 7.6 mg per kg;  p  < 0.032).
CONCLUSION


The recovery in pediatric anesthesia can improve with usage of TIVA with ketofol plus lidocaine admixture with a reduced McFarlan dose regimen.",2022,"The lidoketofol group showed lower fentanyl consumption per kg (2.1 µg per kg vs. 2.3 µg per kg;  p  < 0.056) and lower propofol consumption (6.6 mg per kg vs. 7.6 mg per kg;  p  < 0.032).
","['Two hundred children from the ages of 1-12 years who underwent short surgical procedures', 'Pediatric Patients', 'children']","['lidocaine', 'Propofol mixtures (ketofol', 'total intravenous anesthesia (TIVA) with ketofol and ketofol with lidocaine', 'Ketofol versus Combination of Ketofol and Lidocaine', 'lidocaine (lidoketofol', 'lidoketofol']","['lower length of stay', 'anesthesia duration', 'fentanyl consumption', 'lower propofol consumption', 'Extubation time', 'extubating time, anesthesia duration and the length of stay in the post-anesthesia care unit (PACU']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}]",200.0,0.0461983,"The lidoketofol group showed lower fentanyl consumption per kg (2.1 µg per kg vs. 2.3 µg per kg;  p  < 0.056) and lower propofol consumption (6.6 mg per kg vs. 7.6 mg per kg;  p  < 0.032).
","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Nevešćanin Biliškov', 'Affiliation': 'Department of Anesthesiology, Reanimatology and Intensive Care, University Hospital of Split, Spinčićeva 1, 21000 Split, Croatia.'}, {'ForeName': 'Danijela', 'Initials': 'D', 'LastName': 'Gulam', 'Affiliation': 'School of Medicine, University of Split, Šoltanska 2, 21000 Split, Croatia.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Žaja', 'Affiliation': 'Department of Anesthesiology, Reanimatology and Intensive Care, University Hospital of Split, Spinčićeva 1, 21000 Split, Croatia.'}, {'ForeName': 'Zenon', 'Initials': 'Z', 'LastName': 'Pogorelić', 'Affiliation': 'School of Medicine, University of Split, Šoltanska 2, 21000 Split, Croatia.'}]","Children (Basel, Switzerland)",['10.3390/children9020282']
2304,35204997,Impact of the COVID-19 Pandemic on Emergency Care Utilization and Outcomes in Pediatric Patients with Intussusception.,"BACKGROUND


We determined whether a decrease in healthcare utilization patterns during the COVID-19 pandemic affected the treatment process of pediatric patients with intussusception.
METHODS


Patients with suspected intussusception who had ICD-10 code K561 as their discharge diagnosis from the national database were selected, and those who underwent either radiologic and/or surgical reduction were defined as true intussusception patients. We compared the time periods from patients visiting the ED to ultrasound, radiologic reduction and/or surgical reduction between the study group (first half of 2020, COVID-19 period) and the control groups (control group 1: first half of 2019, control group 2: second half of 2019).
RESULTS


The number of suspected intussusception patients in each group was 1223, 1576, and 624, and the incidence rates were 7.85, 11.30, and 4.19 per 100,000 person-half-years (control group 1, control group 2, study group, respectively,  p  < 0.05). No differences in terms of the time from the ED visit to ultrasound, radiological reduction and/or surgical reduction were noted between the study group and the control groups.
CONCLUSIONS


In Korea, the COVID-19 pandemic did not significantly affect the ED treatment process or the results of patients with intussusception.",2022,"No differences in terms of the time from the ED visit to ultrasound, radiological reduction","['Patients with suspected intussusception who had ICD-10 code K561 as their discharge diagnosis from the national database were selected, and those who underwent either radiologic and/or surgical reduction were defined as true intussusception patients', 'pediatric patients with intussusception', 'Pediatric Patients with Intussusception']",['COVID-19 Pandemic'],"['and/or surgical reduction', 'incidence rates', 'healthcare utilization patterns', 'radiologic reduction and/or surgical reduction', 'time from the ED visit to ultrasound, radiological reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0021933', 'cui_str': 'Intussusception of intestine'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",,0.038351,"No differences in terms of the time from the ED visit to ultrasound, radiological reduction","[{'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Bundang Hospital, Seongnam 13620, Korea.'}, {'ForeName': 'Young Sun', 'Initials': 'YS', 'LastName': 'Ro', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Hyuksool', 'Initials': 'H', 'LastName': 'Kwon', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Bundang Hospital, Seongnam 13620, Korea.'}, {'ForeName': 'Dongbum', 'Initials': 'D', 'LastName': 'Suh', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Bundang Hospital, Seongnam 13620, Korea.'}, {'ForeName': 'Sungwoo', 'Initials': 'S', 'LastName': 'Moon', 'Affiliation': 'National Emergency Medical Center, National Medical Center, Seoul 04564, Korea.'}]","Children (Basel, Switzerland)",['10.3390/children9020277']
2305,35204977,Enhancing Joint Attention Skills in Children on the Autism Spectrum through an Augmented Reality Technology-Mediated Intervention.,"In the present study, the effects of an intervention based on an augmented reality technology called Pictogram Room were examined. The objective of the intervention was to improve the responding to joint attention (RJA) skills of gaze following and pointing in six children on the autism spectrum between 3 and 8 years old. A multiple baseline single-subject experimental design was conducted for 12 weeks in a school setting. Results indicated that all of the participant children improved performance in RJA following the intervention. Improvements were maintained over time and generalised to real-world situations. These findings demonstrate that autistic children can improve their RJA skills with a targeted and engaging intervention based on an accessible augmented reality technology tool.",2022,The objective of the intervention was to improve the responding to joint attention (RJA) skills of gaze following and pointing in six children on the autism spectrum between 3 and 8 years old.,"['six children on the autism spectrum between 3 and 8 years old', 'autistic children']",[],"['performance in RJA', 'responding to joint attention (RJA) skills of gaze', 'Enhancing Joint Attention Skills']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}]",6.0,0.0393336,The objective of the intervention was to improve the responding to joint attention (RJA) skills of gaze following and pointing in six children on the autism spectrum between 3 and 8 years old.,"[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pérez-Fuster', 'Affiliation': 'Department of Educational Psychology and Psychobiology, School of Education, Universidad Internacional de La Rioja, 26006 Logroño, Spain.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Herrera', 'Affiliation': 'Autism and Technologies Laboratory, University Research Institute on Robotics and Information and Communication Technologies (IRTIC), Universitat de València, 46010 Valencia, Spain.'}, {'ForeName': 'Lila', 'Initials': 'L', 'LastName': 'Kossyvaki', 'Affiliation': 'Department of Disability, Inclusion and Special Needs (DISN), School of Education, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ferrer', 'Affiliation': 'Department of Developmental and Educational Psychology, Faculty of Psychology, Universitat de València, 46010 Valencia, Spain.'}]","Children (Basel, Switzerland)",['10.3390/children9020258']
2306,35204970,"A Preliminary Study of Assessing Gaze, Interoception and School Performance among Children with Neurodevelopmental Disorders: The Feasibility of VR Classroom.","Children with developmental disabilities (DDs) have sensory modulation disorders that interrelate school performance. Virtual reality (VR) has demonstrated the potential to become a neuropsychological assessment modality. This study was conducted to explore the feasibility of the VR classroom for assessing their characteristics of gaze, school performance, and interoception. School-aged children were assigned to the DD group or control group. A VR classroom was designed to evaluate their gaze patterns to distracting events. Interoception was assessed using the Heart Rate Perception test and the Multidimensional Assessment of Interoceptive Awareness (MAIA). The DD group had a significantly longer gaze duration on the virtual teacher during 30-45 s of the VR classroom event ( p  < 0.05). The mean score of the quiz and the Heart Rate Perception test showed a significant tendency to be lower than the children of the control group. The DD group scored significantly lower in six of eight subscales of the MAIA. These results showed the potential of VR classroom to evaluate the difference of sensory modulation between school-aged children with DDs and typically developed children. Future research is necessary to investigate the validity of the VR environment used in this study.",2022,The mean score of the quiz and the Heart Rate Perception test showed a significant tendency to be lower than the children of the control group.,"['Children with Neurodevelopmental Disorders', 'Children with developmental disabilities (DDs', 'School-aged children']","['VR Classroom', 'Virtual reality (VR', 'VR classroom']","['Heart Rate Perception test and the Multidimensional Assessment of Interoceptive Awareness (MAIA', 'Gaze, Interoception and School Performance', 'sensory modulation', 'longer gaze duration', 'mean score of the quiz and the Heart Rate Perception test']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1535926', 'cui_str': 'Neurodevelopmental disorder'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C3850156', 'cui_str': 'Interoception'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.040365,The mean score of the quiz and the Heart Rate Perception test showed a significant tendency to be lower than the children of the control group.,"[{'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Ide-Okochi', 'Affiliation': 'Graduate School of Health Sciences, Kumamoto University, Kumamoto City 862-0976, Japan.'}, {'ForeName': 'Nobutomo', 'Initials': 'N', 'LastName': 'Matsunaga', 'Affiliation': 'Graduate School of Science and Technology, Kumamoto University, Kumamoto City 860-0862, Japan.'}, {'ForeName': 'Hiro', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'Graduate School of Science and Technology, Kumamoto University, Kumamoto City 860-0862, Japan.'}]","Children (Basel, Switzerland)",['10.3390/children9020250']
2307,35204923,Short Mindfulness-Based Relaxation Training Has No Effects on Executive Functions but May Reduce Baseline Cortisol Levels of Boys in First Grade: A Pilot Study.,"(1) Background: Executive functions are important for academic performance and school readiness. Children's executive function skills are found to be improved by mindfulness-based interventions, and these programs are also effective in stress reduction. The aim of this study was to evaluate the feasibility and the effects of a short mindfulness-based relaxation training compared to a passive control condition right before school entry on executive function skills and cortisol levels. (2) Methods: The feasibility and the effects of the intervention before school entry were tested with 61 preschoolers. The final sample consisted of 51 participants (M age  = 81.90 months,  SD  = 5.45; 41% male). Short-term memory, executive function skills and cortisol levels before and after the intervention were assessed. Additionally, cortisol levels were assessed one week and one month after school entry. (3) Results: There was a significant sex difference in the effects of the intervention on children's cortisol levels ( p  = 0.026,  η 2  = 0.134). The mindfulness-based relaxation training applied before school entry prevented a rise in boys' cortisol levels one week after starting school. (4) Conclusion: A short mindfulness-based intervention before starting school could be effective in fostering physiological stress management in boys.",2022,The mindfulness-based relaxation training applied before school entry prevented a rise in boys' cortisol levels one week after starting school.,"['51 participants (M age  = 81.90 months,  SD  = 5.45; 41% male', 'boys', 'Boys in First Grade', '61 preschoolers']","['Short Mindfulness-Based Relaxation Training', 'mindfulness-based relaxation training', 'short mindfulness-based relaxation training']","['Executive Functions', ""children's cortisol levels"", 'cortisol levels', ""Children's executive function skills"", 'Short-term memory, executive function skills and cortisol levels', 'executive function skills and cortisol levels']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",51.0,0.0105517,The mindfulness-based relaxation training applied before school entry prevented a rise in boys' cortisol levels one week after starting school.,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Koncz', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, 1064 Budapest, Hungary.'}, {'ForeName': 'Reka', 'Initials': 'R', 'LastName': 'Kassai', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, 1064 Budapest, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Demetrovics', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, 1064 Budapest, Hungary.'}, {'ForeName': 'Zsofia K', 'Initials': 'ZK', 'LastName': 'Takacs', 'Affiliation': 'School of Health in Social Science, University of Edinburgh, Edinburgh EH8 9AG, UK.'}]","Children (Basel, Switzerland)",['10.3390/children9020203']
2308,35204903,Children on the Autism Spectrum and the Use of Virtual Reality for Supporting Social Skills.,"BACKGROUND


Autism spectrum disorders (ASDs) are characterized by differences in socio-pragmatic communication. These conditions are allocated within a ""spectrum"" of phenotypic variability. Virtual reality (VR) is a useful tool for healthcare intervention and particularly safely advancing social abilities in children with ASD.
METHODS


In our study two types of intervention for improving social skills were compared: (i) emotional training obtained by the use of virtual reality (Gr1), (ii) traditional emotional training performed individually with a therapist (Gr2). We aimed to identify the intervention with the shortest acquisition time for the proposed social tasks.
RESULTS


Our findings show that both types of intervention had the same acquisition time for the recognition of primary emotions. However, for the use of primary and secondary emotions, the group using VR showed shorter acquisition times.
CONCLUSIONS


These findings together with previous preliminary datasuggest that VR can be a promising, dynamic and effective practice for the support of basic and complex social skills of these individuals.",2022,"However, for the use of primary and secondary emotions, the group using VR showed shorter acquisition times.
","['children with ASD', 'Autism spectrum disorders (ASDs']","['emotional training obtained by the use of virtual reality (Gr1), (ii) traditional emotional training performed individually with a therapist (Gr2', 'Virtual reality (VR']","['shorter acquisition times', 'social skills']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}]",,0.0141062,"However, for the use of primary and secondary emotions, the group using VR showed shorter acquisition times.
","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Frolli', 'Affiliation': 'Disability Research Centre, University of International Studies in Rome, Via Cristoforo Colombo, 200, 00147 Rome, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Savarese', 'Affiliation': 'Department of Medicine and Surgery, University of Salerno, 84084 Salerno, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Di Carmine', 'Affiliation': 'Disability Research Centre, University of International Studies in Rome, Via Cristoforo Colombo, 200, 00147 Rome, Italy.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Bosco', 'Affiliation': 'FINDS-Italian Neuroscience and Developmental Disorders Foundation, 81040 Caserta, Italy.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Saviano', 'Affiliation': 'FINDS-Italian Neuroscience and Developmental Disorders Foundation, 81040 Caserta, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Rega', 'Affiliation': 'Department of Humanities, University of Naples, 80133 Naples, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Carotenuto', 'Affiliation': 'Clinic of Child and Adolescent Neuropsychiatry, Department of Mental Health, Physical and Preventive Medicine, Università degli Studi della Campania ""Luigi Vanvitelli"", 80100 Naples, Italy.'}, {'ForeName': 'Maria Carla', 'Initials': 'MC', 'LastName': 'Ricci', 'Affiliation': 'Disability Research Centre, University of International Studies in Rome, Via Cristoforo Colombo, 200, 00147 Rome, Italy.'}]","Children (Basel, Switzerland)",['10.3390/children9020181']
2309,35204900,The Role of Glucocorticoids in the Treatment of Multisystem Inflammatory Syndrome (MIS-C)-Data from POLISH MIS-C Registry.,"BACKGROUND


Multisystem inflammatory syndrome (MIS-C) is a condition related to COVID-19. It's most significant feature is cardiac involvement.
METHODS


We have analyzed data from 42 hospitals in the Polish MIS-C Registry. To compare the effect of GCS on fever, we formed two groups: the first treated with IVIG and the second treated with IVIG+GCS.
RESULTS


There were 111 boys and 56 girls; the mean age was 8.57 years. All the patients were treated with IVIG: 76 patients with IVIG only, and 91 patients with IVIG+GCS. There were no statistically significant differences between the groups regarding age, gender, BMI, or inflammatory markers. Methylprednisolone was the most common drug (80%). Echocardiographic abnormalities on admission were more prevalent in the IVIG+GCS group. Mean time from IVIG infusion to subsidence of fever was 1.1 days, and 1.5 for those in the IVIG+GCS group.
CONCLUSIONS


GCS are commonly used in the treatment of MIS-C patients in Poland. Various GCS regimens are used, from a single dose to a month-long therapy. Children with lower lymphocyte levels and cardiac abnormalities on an echocardiographic examination performed on admission were more likely to receive GCS+IVIG. The effect of GCS is difficult to access as patients were not randomly assigned to receive the treatment.",2022,"There were no statistically significant differences between the groups regarding age, gender, BMI, or inflammatory markers.","['42 hospitals in the Polish MIS-C Registry', 'MIS-C patients in Poland', '111 boys and 56 girls; the mean age was 8.57 years', '76 patients with IVIG only, and 91 patients with IVIG+GCS']","['Glucocorticoids', 'IVIG', 'GCS', 'IVIG+GCS', 'Methylprednisolone']","['Mean time from IVIG infusion to subsidence of fever', 'Echocardiographic abnormalities on admission']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0457453', 'cui_str': 'On admission'}]",111.0,0.072864,"There were no statistically significant differences between the groups regarding age, gender, BMI, or inflammatory markers.","[{'ForeName': 'Ewelina', 'Initials': 'E', 'LastName': 'Gowin', 'Affiliation': 'Health Promotion Department, Poznan University of Medical Sciences, Fredry 10, 61-701 Poznan, Poland.'}, {'ForeName': 'Kacper', 'Initials': 'K', 'LastName': 'Toczyłowski', 'Affiliation': 'Department of Pediatric Infectious Diseases, Medical University of Bialystok, Waszyngtona 17, 15-274 Bialystok, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Sulik', 'Affiliation': 'Department of Pediatric Infectious Diseases, Medical University of Bialystok, Waszyngtona 17, 15-274 Bialystok, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Wysocki', 'Affiliation': 'Health Promotion Department, Poznan University of Medical Sciences, Fredry 10, 61-701 Poznan, Poland.'}, {'ForeName': 'Danuta', 'Initials': 'D', 'LastName': 'Januszkiewicz-Lewandowska', 'Affiliation': 'Department of Pediatric Oncology, Hematology and Transplantology, Poznan University of Medical Sciences, Szpitalna 27/33, 60-572 Poznan, Poland.'}]","Children (Basel, Switzerland)",['10.3390/children9020178']
2310,35204894,Impact of an Online Parenting Support Programme on Children's Quality of Life.,"The study aims to describe the parental use of an online parenting support programme, the 'Open Window to Family' (JAF) and to evaluate its impact on perceived children's quality of life (QoL). This programme makes online resources available to support positive parenting. The study included 363 parents ( n intervention group  = 142) who completed measures to evaluate their children's QoL. The results suggest that using the programme for a longer time and accessing more information/services are positively related to the perception of utility but not to the frequency of use. The programme proved to be more useful for specific difficulties and to search for specific information. We found high levels of parental perception of children's well-being, both physical and psychological, and lower values in social support and relationships with peers. No differences were observed between the total QoL of children in the intervention group and control group. The differences in the dimensions of QoL are due to interaction with the level of education of the mother: mothers with higher education reported higher physical well-being, social support, relationships with peers, and school context. Guidelines are suggested to enhance the accessibility of this type of programme as well as enhance its impact on parents and children.",2022,No differences were observed between the total QoL of children in the intervention group and control group.,"[""363 parents ( n intervention group  = 142) who completed measures to evaluate their children's QoL""]","['Online Parenting Support Programme', ""online parenting support programme, the 'Open Window to Family' (JAF""]","['total QoL of children', ""children's quality of life (QoL"", ""Children's Quality of Life""]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449768', 'cui_str': 'Measured to'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",363.0,0.00951521,No differences were observed between the total QoL of children in the intervention group and control group.,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Nunes', 'Affiliation': 'Psychology Research Centre (CIP), Universidade do Algarve, Campus de Gambelas, 8005-139 Faro, Portugal.'}, {'ForeName': 'Cátia', 'Initials': 'C', 'LastName': 'Martins', 'Affiliation': 'Psychology Research Centre (CIP), Universidade do Algarve, Campus de Gambelas, 8005-139 Faro, Portugal.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Brás', 'Affiliation': 'Psychology Research Centre (CIP), Universidade do Algarve, Campus de Gambelas, 8005-139 Faro, Portugal.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Carmo', 'Affiliation': 'Psychology Research Centre (CIP), Universidade do Algarve, Campus de Gambelas, 8005-139 Faro, Portugal.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Departamento de Ciências Sociais e da Educação, Universidade do Algarve, Campus de Gambelas, 8005-139 Faro, Portugal.'}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Pina', 'Affiliation': 'Administração Regional de Saúde do Algarve, 8005-145 Faro, Portugal.'}]","Children (Basel, Switzerland)",['10.3390/children9020173']
2311,35204866,The Effect of Corrective Feedback in Basic Cognitive Tasks: A Study in Early Childhood.,"The aim of this study was to examine the effect of trial-by-trial corrective feedback in a go-no-go task for children. A sample of 40 preschool students, divided into 4- and 5-year-olds, participated in the study, as well as a group of 20 university students. All the groups performed the task in a counterbalanced design of blocks with and without corrective feedback. Reaction time and accuracy rate were measured as dependent variables. Moreover, reaction time was also analyzed through an ex-Gaussian fit. Children were slightly more accurate and slower under the presence of corrective feedback, suggesting a more conservative pattern. University students were faster, but corrective feedback did not reach the statistical level. Regarding reaction time components, a reduction of the distribution tails, depicted by the τ parameter, was found for both groups under the corrective feedback condition. This suggests that parameterization of reaction time can be considered as a strategy for a more detailed analysis to examine the effect of corrective feedback, even at early ages. In this way, corrective feedback depicted beneficial effects in the τ parameter at early ages, suggesting its use in basic cognitive tasks based on go-no-go but not for older groups.",2022,"Regarding reaction time components, a reduction of the distribution tails, depicted by the τ parameter, was found for both groups under the corrective feedback condition.","['40 preschool students, divided into 4- and 5-year-olds, participated in the study, as well as a group of 20 university students', 'University students', 'children', 'Basic Cognitive Tasks']",['Corrective Feedback'],"['reaction time', 'Reaction time and accuracy rate']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",40.0,0.0341292,"Regarding reaction time components, a reduction of the distribution tails, depicted by the τ parameter, was found for both groups under the corrective feedback condition.","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Moret-Tatay', 'Affiliation': 'MEB Lab, Faculty of Psychology, Universidad Católica de Valencia San Vicente Mártir, Avenida de la Ilustración, 2, 46100 Burjassot, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Vaquer-Cardona', 'Affiliation': 'MEB Lab, Faculty of Psychology, Universidad Católica de Valencia San Vicente Mártir, Avenida de la Ilustración, 2, 46100 Burjassot, Spain.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Bernabé-Valero', 'Affiliation': 'MEB Lab, Faculty of Psychology, Universidad Católica de Valencia San Vicente Mártir, Avenida de la Ilustración, 2, 46100 Burjassot, Spain.'}, {'ForeName': 'José Salvador', 'Initials': 'JS', 'LastName': 'Blasco-Magraner', 'Affiliation': 'Department of Didactics of Musical, Plastic and Corporal Expression, Faculty of Teaching, Av. Tarongers 4, 46022 Valencia, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Sáiz-Mauleón', 'Affiliation': 'Escuela Técnica Superior de Ingeniería del Diseño (ETSID), Universitat Politècnica de València (UPV), Camino de Vera, s/n, 46022 Valencia, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Jorques-Infante', 'Affiliation': 'MEB Lab, Faculty of Psychology, Universidad Católica de Valencia San Vicente Mártir, Avenida de la Ilustración, 2, 46100 Burjassot, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Iborra-Marmolejo', 'Affiliation': 'MEB Lab, Faculty of Psychology, Universidad Católica de Valencia San Vicente Mártir, Avenida de la Ilustración, 2, 46100 Burjassot, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Beneyto-Arrojo', 'Affiliation': 'MEB Lab, Faculty of Psychology, Universidad Católica de Valencia San Vicente Mártir, Avenida de la Ilustración, 2, 46100 Burjassot, Spain.'}]","Children (Basel, Switzerland)",['10.3390/children9020145']
2312,35206406,"Influence of ""Face-to-Face Contact"" and ""Non-Face-to-Face Contact"" on the Subsequent Decline in Self-Rated Health and Mental Health Status of Young, Middle-Aged, and Older Japanese Adults: A Two-Year Prospective Study.","This study aims to identify the independent influence of face-to-face contact (FFC) and non-face-to-face contact (NFFC) on the subsequent decline in self-rated health and mental health status by age. A total of 12,000 participants were randomly selected among residents in the study area, and 1751 of them responded to both the 2016 and 2018 mail surveys. The participants were subsequently classified into three age groups (25-49: Young adults; 50-64: Mid-aged adults; and 65-84: Older adults). Social contact was assessed by computing the frequencies of FFC and NFFC. Multiple logistic regression analysis showed the risk of social contact on the decline in self-rated health and World Health Organization-Five Well-Being Index. Both FFC and NFFC were significantly associated with maintaining mental health; however, the impacts of FFC on mental health were more significant than that of NFFC among older adults and young adults. Compared with the no contact group, FFC was significantly associated with maintaining self-rated health in mid-aged adults. The influence of FFC and NFFC on health differed by age group.",2022,"Compared with the no contact group, FFC was significantly associated with maintaining self-rated health in mid-aged adults.","['12,000 participants were randomly selected among residents in the study area, and 1751 of them responded to both the 2016 and 2018 mail surveys', 'participants were subsequently classified into three age groups (25-49: Young adults; 50-64: Mid-aged adults; and 65-84: Older adults', 'Self-Rated Health and Mental Health Status of Young, Middle-Aged, and Older Japanese Adults', 'older adults and young adults', 'self-rated health and mental health status by age']","['face-to-face contact (FFC) and non-face-to-face contact (NFFC', 'FFC and NFFC', 'Face-to-Face Contact"" and ""Non-Face-to-Face Contact', 'NFFC']","['maintaining mental health', 'Social contact', 'self-rated health and World Health Organization-Five Well-Being Index', 'FFC']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0237101', 'cui_str': 'Social interaction finding'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",12000.0,0.0314457,"Compared with the no contact group, FFC was significantly associated with maintaining self-rated health in mid-aged adults.","[{'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, Tokyo 173-0015, Japan.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Nonaka', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, Tokyo 173-0015, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuraoka', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, Tokyo 173-0015, Japan.'}, {'ForeName': 'Yoh', 'Initials': 'Y', 'LastName': 'Murayama', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, Tokyo 173-0015, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Murayama', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, Tokyo 173-0015, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Nemoto', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, Tokyo 173-0015, Japan.'}, {'ForeName': 'Motoki', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, Tokyo 173-0015, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Matsunaga', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, Tokyo 173-0015, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, Tokyo 173-0015, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Murayama', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, Tokyo 173-0015, Japan.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Kobayashi', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, Tokyo 173-0015, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph19042218']
2313,35206394,"The Role of Parent Engagement in a Web-Based Preventive Parenting Intervention for Child Mental Health in Predicting Parenting, Parent and Child Outcomes.","Although parents' engagement in parenting programmes has frequently been posited to influence the efficacy and dissemination of these programmes, its relationship with intervention outcomes in parenting programmes is understudied. This study examined the predictive value of parental engagement on preventive parenting outcomes in a tailored online parenting programme aimed at enhancing parental protective factors and reducing risk factors for child depression and anxiety disorders. The present study also explored the associations between parental engagement and other parent, child and family outcomes. Data were collected from a community sample of 177 parents who received a tailored online parenting programme ('Parenting Resilient Kids'; PaRK) and their children as part of a randomised controlled trial. Participants completed measures on parenting, child anxiety and depressive symptoms, health-related quality of life and family functioning on three occasions. Multiple regressions showed that parental engagement explained additional variance in preventive parenting (most proximal outcomes) at post-intervention and 12-month follow-up. Indicators of higher levels of parental engagement, operationalised by greater proportions of recommended programme modules and intended goals completed, uniquely predicted higher levels of preventing parenting. Higher levels of parental engagement also predicted higher levels of parental acceptance and parental psychosocial health-related quality of life, lower levels of parental psychological control and lower levels of impairments in child health-related quality of life. However, parental engagement did not explain additional variance in parent or child reported anxiety or depressive symptoms. This study provides support for the role of parental engagement in facilitating parenting changes in parenting-focused interventions.",2022,Multiple regressions showed that parental engagement explained additional variance in preventive parenting (most proximal outcomes) at post-intervention and 12-month follow-up.,"['child depression and anxiety disorders', '177 parents who received a']","[""tailored online parenting programme ('Parenting Resilient Kids'; PaRK"", 'Web-Based Preventive Parenting Intervention']","['anxiety or depressive symptoms', 'parental acceptance and parental psychosocial health-related quality of life, lower levels of parental psychological control and lower levels of impairments in child health-related quality of life', 'parenting, child anxiety and depressive symptoms, health-related quality of life and family functioning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}]",177.0,0.0471494,Multiple regressions showed that parental engagement explained additional variance in preventive parenting (most proximal outcomes) at post-intervention and 12-month follow-up.,"[{'ForeName': 'Wan Hua', 'Initials': 'WH', 'LastName': 'Sim', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, VIC 3800, Australia.'}, {'ForeName': 'Anthony F', 'Initials': 'AF', 'LastName': 'Jorm', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC 3000, Australia.'}, {'ForeName': 'Marie B H', 'Initials': 'MBH', 'LastName': 'Yap', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, VIC 3800, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph19042191']
2314,35206331,Treatment Preferences for Pharmacological versus Psychological Interventions among Primary Care Providers in Nepal: Mixed Methods Analysis of a Pilot Cluster Randomized Controlled Trial.,"There is increasing evidence supporting the effectiveness of psychological interventions in low- and middle-income countries. However, primary care providers (PCPs) may prefer treating patients with medication. A secondary exploratory analysis of a pilot cluster randomized controlled trial was conducted to evaluate psychological vs. pharmacological treatment preferences among PCPs. Thirty-four health facilities, including 205 PCPs, participated in the study, with PCPs in 17 facilities assigned to a standard version of the mental health Gap Action Programme (mhGAP) training delivered by mental health specialists. PCPs in the other 17 facilities received mhGAP instruction delivered by specialists and people with lived experience of mental illness (PWLE), using a training strategy entitled Reducing Stigma among HealthcAre ProvidErs (RESHAPE). Pre- and post- intervention attitudes were measured through quantitative and qualitative tools. Qualitative interviews with 49 participants revealed that PCPs in both arms endorsed counseling's benefits and collaboration within the health system to provide counseling. In the RESHAPE arm, PCPs were more likely to increase endorsement of statements such as ""depression improves without medication"" ( F  = 9.83,  p  < 0.001), ""not all people with depression must be treated with antidepressants"" ( χ 2  = 17.62,  p  < 0.001), and ""providing counseling to people who have alcohol abuse problems is effective"" ( χ 2  = 26.20,  p  < 0.001). These mixed-method secondary findings from a pilot trial suggest that in-person participation of PWLE in training PCPs may not only reduce stigma but also increase PCPs' support of psychological interventions. This requires further investigation in a full-scale trial.",2022,Qualitative interviews with 49 participants revealed that PCPs in both arms endorsed counseling's benefits and collaboration within the health system to provide counseling.,"['Primary Care Providers in Nepal', 'Thirty-four health facilities, including 205 PCPs, participated in the study, with PCPs in 17 facilities assigned to a']","['mhGAP instruction', 'standard version of the mental health Gap Action Programme (mhGAP) training delivered by mental health specialists', 'Pre- and post', 'training strategy entitled Reducing Stigma among HealthcAre ProvidErs (RESHAPE', 'Pharmacological versus Psychological Interventions']",[],"[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0478057,Qualitative interviews with 49 participants revealed that PCPs in both arms endorsed counseling's benefits and collaboration within the health system to provide counseling.,"[{'ForeName': 'Anvita', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.'}, {'ForeName': 'Dristy', 'Initials': 'D', 'LastName': 'Gurung', 'Affiliation': ""Centre for Global Mental Health, Health Services and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Sauharda', 'Initials': 'S', 'LastName': 'Rai', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC 27710, USA.'}, {'ForeName': 'Bonnie N', 'Initials': 'BN', 'LastName': 'Kaiser', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC 27710, USA.'}, {'ForeName': 'Cori L', 'Initials': 'CL', 'LastName': 'Cafaro', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC 27710, USA.'}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Sikkema', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC 27710, USA.'}, {'ForeName': 'Crick', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Centre for Global Mental Health, Health Services and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Nagendra P', 'Initials': 'NP', 'LastName': 'Luitel', 'Affiliation': 'Transcultural Psychosocial Organization (TPO) Nepal, Baluwatar 44616, Nepal.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Kohrt', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC 27710, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph19042149']
2315,35206803,"Effects of a Reminiscence Program on Meaning of Life, Sense of Coherence and Coping in Older Women Living in Nursing Homes during COVID-19.","Aging is a dynamic process that can bring well-being but also physical and cognitive decline. Older adults can draw on their personal resources to help them cope and thrive through the aging process. Having personal resources to cope and ensure older adults' well-being is important. Psychological strengths such as a sense of coherence, resilience, and coping are protective against the adversity associated with health problems such as those stemming from the COVID-19 pandemic. Our study's purpose was to investigate the usefulness of reminiscence therapy for older women living in nursing homes during the COVID-19 pandemic. A sample composed of 29 older women was evaluated with the Purpose-in-Life Test (PIL), Sense of Coherence (SOC-13) and Brief Cope Inventory (COPE-28). Our reminiscence program consisted of 10 sessions lasting 60 min each. Reminiscence therapy is a psychological intervention for older adults to assist in remembering and interpreting the life events, feelings, and thoughts that define and give meaning to the person's life. Reminiscence can lead to positive mental health and other elements of particular relevance to older adults. In each session, we worked on a different theme that promoted the memory of positive emotions: optimal experience, decisive moment, stresses, tensions, problems and solutions, memories of childhood, adolescence, maturity, significant people in life, sense of life, and future script. We compared an intervention group ( n  = 12) with a control group ( n  = 17) using a pre-post, single-blind design. Significant results were obtained and showed that reminiscence therapy was effective in increasing meaning of life, sense of coherence, and coping in older women. The reminiscence therapy applied yielded positive effects in older female participants living in a nursing home during COVID-19 pandemic.",2022,The reminiscence therapy applied yielded positive effects in older female participants living in a nursing home during COVID-19 pandemic.,"['29 older women', 'Older adults', 'older women', 'Older Women Living in Nursing Homes during COVID-19', 'older female participants living in a nursing home during COVID-19 pandemic', 'older adults', 'older women living in nursing homes during the COVID-19 pandemic']","['Reminiscence therapy', 'reminiscence therapy', 'Reminiscence Program']","['Life Test (PIL), Sense of Coherence (SOC-13) and Brief Cope Inventory (COPE-28', 'meaning of life, sense of coherence, and coping', 'Meaning of Life, Sense of Coherence and Coping']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0150321', 'cui_str': 'Reminiscence therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",29.0,0.0189002,The reminiscence therapy applied yielded positive effects in older female participants living in a nursing home during COVID-19 pandemic.,"[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Sales', 'Affiliation': 'Department of Development Psychology, Faculty of Psychology, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Sacramento', 'Initials': 'S', 'LastName': 'Pinazo-Hernandis', 'Affiliation': 'Department of Social Psychology, Faculty of Psychology, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Martinez', 'Affiliation': 'Department of Social Psychology, Faculty of Psychology, University of Valencia, 46010 Valencia, Spain.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare10020188']
2316,35200040,Safety and Efficacy Evaluation of Antithrombotic Therapy with Rivaroxaban and Clopidogrel After PCI in Chinese Patients.,"OBJECTIVE


To investigate the efficacy and safety of the antithrombotic therapy using the oral anticoagulant rivaroxaban and clopidogrel in Chinese patients with acute coronary syndrome complicated with atrial fibrillation after percutaneous coronary intervention.
METHODS


A total of 100 patients were selected. Patients were randomly divided into two groups: the treatment group (rivaroxaban group) received a therapy of rivaroxaban and clopidogrel. The control group (warfarin group) receivied a combined treatment of warfarin, clopidogrel, and aspirin. The primary outcome endpoint was evaluated based on the adverse cardiac and cerebrovascular events within 12 months.
RESULTS


A total of 8 (8.00%) main adverse cardiac and cerebrovascular events occurred during the 12 months of follow-up, including 5 (9.80%) in the warfarin group and 3 (6.10%) in the rivaroxaban group. The risk of having main adverse cardiac and cerebrovascular events in the two groups was comparable (P = 0.479). A total of 9 patients (9.00%) were found to have bleeding events, among which 8 patients (15.7%) were in the warfarin group, whereas only 1 patient (2.00%) was in the rivaroxaban group. Therefore, the risk of bleeding in the warfarin group was significantly higher than that in the rivaroxaban group (P = 0.047).
CONCLUSIONS


In Chinese patients with acute coronary syndrome complicated with atrial fibrillation, the efficacy of the dual therapy of oral anticoagulant rivaroxaban plus clopidogrel after percutaneous coronary intervention was similar to that of the traditional triple therapy combined with warfarin, aspirin and clopidogrel, but it has a better safety property, which has potential to widely apply to antithrombotic therapy after PCI.",2022,The risk of having main adverse cardiac and cerebrovascular events in the two groups was comparable (P = 0.479).,"['Chinese Patients', 'A total of 100 patients were selected', 'Chinese patients with acute coronary syndrome complicated with atrial fibrillation after percutaneous coronary intervention', 'Chinese patients with acute coronary syndrome complicated with atrial fibrillation']","['warfarin, aspirin and clopidogrel', 'rivaroxaban plus clopidogrel', 'rivaroxaban and clopidogrel', 'Rivaroxaban and Clopidogrel', 'control group (warfarin group) receivied a combined treatment of warfarin, clopidogrel, and aspirin', 'treatment group (rivaroxaban', 'antithrombotic therapy', 'rivaroxaban', 'warfarin']","['risk of having main adverse cardiac and cerebrovascular events', 'adverse cardiac and cerebrovascular events', 'bleeding events', 'efficacy and safety', 'risk of bleeding']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",100.0,0.0594369,The risk of having main adverse cardiac and cerebrovascular events in the two groups was comparable (P = 0.479).,"[{'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Ya-Qing', 'Initials': 'YQ', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xiao-Ran', 'Initials': 'XR', 'LastName': 'Cui', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Ling-Zhi', 'Initials': 'LZ', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Ji-Dong', 'Initials': 'JD', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, China.'}]",Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis,['10.1177/10760296221074681']
2317,35200592,Minimally Invasive Surgery for Cervical Cancer in Light of the LACC Trial: What Have We Learned?,"Cervical cancer is the most common gynecologic malignancy and the fourth most common cancer in women worldwide. Over the last two decades, minimally invasive surgery (MIS) emerged as the mainstay in the surgical management of cervical cancer, bringing advantages such as lower operative morbidity and shorter hospital stay compared to open surgery while maintaining comparable oncologic outcomes in numerous retrospective studies. However, in 2018, a prospective phase III randomized controlled trial, ""Laparoscopic Approach to Carcinoma of the Cervix (LACC)"", unexpectedly reported that MIS was associated with a statistically significant poorer overall survival and disease-free survival compared to open surgery in patients with early-stage cervical cancer. Various hypotheses have been raised by the authors to try to explain these results, but the LACC trial was not powered to answer those questions. In this study, through an exhaustive literature review, we wish to explore some of the potential causes that may explain the poorer oncologic outcomes associated with MIS, including the type of MIS surgery, the size of the lesion, the impact of CO 2  pneumoperitoneum, prior conization, the use of uterine manipulator, the use of protective measures, and the effect of surgical expertise/learning curve.",2022,"Over the last two decades, minimally invasive surgery (MIS) emerged as the mainstay in the surgical management of cervical cancer, bringing advantages such as lower operative morbidity and shorter hospital stay compared to open surgery while maintaining comparable oncologic outcomes in numerous retrospective studies.","['Cervical Cancer in Light of the LACC Trial', 'patients with early-stage cervical cancer']","['minimally invasive surgery (MIS', 'Minimally Invasive Surgery']",['overall survival and disease-free survival'],"[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.26382,"Over the last two decades, minimally invasive surgery (MIS) emerged as the mainstay in the surgical management of cervical cancer, bringing advantages such as lower operative morbidity and shorter hospital stay compared to open surgery while maintaining comparable oncologic outcomes in numerous retrospective studies.","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Touhami', 'Affiliation': 'Gynecologic Oncology Division, Department of Obstetrics and Gynecology, Centre Intégré Universitaire de Santé et Services Sociaux CIUSSS du Saguenay-Lac-Saint-Jean, Sherbrooke University, Sherbrooke, QC J1K 2R1, Canada.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Plante', 'Affiliation': ""Gynecologic Oncology Division, L'Hotel-Dieu de Québec, CHU de Québec, Laval University, Quebec, QC G1V 0A6, Canada.""}]","Current oncology (Toronto, Ont.)",['10.3390/curroncol29020093']
2318,35200590,"CT and 3 Tesla MRI in the TN Staging of Colon Cancer: A Prospective, Blind Study.","(1) Background: Computer tomography (CT) scanning is currently the standard method for staging of colon cancer; however, the CT based preoperative local staging is far from optimal. The purpose of this study was to investigate the sensitivity and specificity of magnetic resonance imaging (MRI) compared to CT in the T- and N-staging of colon cancer. (2) Methods: Patients underwent a standard contrast-enhanced CT examination. For the abdominal MRI scan, a 3 Tesla unit was used, including diffusion weighted imaging (DWI). Experienced radiologists reported the CT and MRI scans blinded to each other and the endpoint of the pathological report. (3) Results: From 2018 to 2021, 134 patients received CT and MRI scans. CT identified 118 of the 134 tumors, whereas MRI identified all tumors. For discriminating between stage T3ab and T3cd, the sensitivity of CT was 51.1% and of MRI 80.0% ( p  = 0.02). CT and MRI showed a sensitivity of 21.4% and 46.4% in detecting pT4 tumors and a specificity of 79.0% and 85.0%, respectively. (4) Conclusion: Compared to CT, the sensitivity of MRI was statistically significantly higher in staging advanced T3cd and T4 tumors. MRI has the potential to be used in the treatment planning of colon cancer.",2022,"CT and MRI showed a sensitivity of 21.4% and 46.4% in detecting pT4 tumors and a specificity of 79.0% and 85.0%, respectively.",['Colon Cancer'],"['Computer tomography (CT) scanning', 'CT and 3 Tesla MRI', 'CT', 'magnetic resonance imaging (MRI', 'standard contrast-enhanced CT examination']","['sensitivity of MRI', 'sensitivity of CT']","[{'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}]",,0.0781934,"CT and MRI showed a sensitivity of 21.4% and 46.4% in detecting pT4 tumors and a specificity of 79.0% and 85.0%, respectively.","[{'ForeName': 'Søren R', 'Initials': 'SR', 'LastName': 'Rafaelsen', 'Affiliation': 'Department of Radiology, Vejle Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Dam', 'Affiliation': 'Department of Radiology, Vejle Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Vagn-Hansen', 'Affiliation': 'Department of Radiology, Vejle Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Møller', 'Affiliation': 'Department of Radiology, Vejle Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark.'}, {'ForeName': 'Hans B', 'Initials': 'HB', 'LastName': 'Rahr', 'Affiliation': 'Danish Colorectal Cancer Center South, Vejle Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Sjöström', 'Affiliation': 'Department of Surgery, Vejle Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lindebjerg', 'Affiliation': 'Danish Colorectal Cancer Center South, Vejle Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark.'}, {'ForeName': 'Torben Frøstrup', 'Initials': 'TF', 'LastName': 'Hansen', 'Affiliation': 'Danish Colorectal Cancer Center South, Vejle Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark.'}, {'ForeName': 'Malene Roland Vils', 'Initials': 'MRV', 'LastName': 'Pedersen', 'Affiliation': 'Department of Radiology, Vejle Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark.'}]","Current oncology (Toronto, Ont.)",['10.3390/curroncol29020091']
2319,35200576,An Individualized Exercise Intervention for People with Multiple Myeloma-Study Protocol of a Randomized Waitlist-Controlled Trial.,"People with multiple myeloma (MM) are second only to people with lung cancer for the poorest reported health-related quality of life (HRQoL) of all cancer types. Whether exercise can improve HRQoL in MM, where bone pain and lesions are common, requires investigation. This trial aims to evaluate the efficacy of an exercise intervention compared with control on HRQoL in people with MM. Following baseline testing, people with MM ( n  = 60) will be randomized to an exercise (EX) or waitlist control (WT) group. EX will complete 12-weeks of supervised (24 sessions) and unsupervised (12 sessions) individualized, modular multimodal exercise training. From weeks 12-52, EX continue unsupervised training thrice weekly, with one optional supervised group-based session weekly from weeks 12-24. The WT will be asked to maintain their current activity levels for the first 12-weeks, before completing the same protocol as EX for the following 52 weeks. Primary (patient-reported HRQoL) and secondary (bone health and pain, fatigue, cardiorespiratory fitness, muscle strength, body composition, disease response, and blood biomarkers) outcomes will be assessed at baseline, 12-, 24- and 52-weeks. Adverse events, attendance, and adherence will be recorded and cost-effectiveness analysis performed. The findings will inform whether exercise should be included as part of standard myeloma care to improve the health of this unique population.",2022,People with multiple myeloma (MM) are second only to people with lung cancer for the poorest reported health-related quality of life (HRQoL) of all cancer types.,"['people with MM ( n  = 60', 'People with multiple myeloma (MM', 'people with MM', 'People with Multiple Myeloma']","['multimodal exercise training', 'Individualized Exercise Intervention', 'exercise (EX) or waitlist control (WT', 'exercise intervention']","['Adverse events, attendance, and adherence', 'HRQoL) and secondary (bone health and pain, fatigue, cardiorespiratory fitness, muscle strength, body composition, disease response, and blood biomarkers) outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.0496935,People with multiple myeloma (MM) are second only to people with lung cancer for the poorest reported health-related quality of life (HRQoL) of all cancer types.,"[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Nicol', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane 4072, Australia.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Woodrow', 'Affiliation': 'Haematology, Division of Cancer, Princess Alexandra Hospital, Brisbane 4102, Australia.'}, {'ForeName': 'Brent J', 'Initials': 'BJ', 'LastName': 'Cunningham', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane 4072, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mollee', 'Affiliation': 'Haematology, Division of Cancer, Princess Alexandra Hospital, Brisbane 4102, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Weber', 'Affiliation': ""Haematology, Cancer Care Services, Royal Brisbane and Women's Hospital, Brisbane 4006, Australia.""}, {'ForeName': 'Michelle D', 'Initials': 'MD', 'LastName': 'Smith', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane 4072, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Nicol', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane 4072, Australia.'}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Gordon', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane 4006, Australia.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Hill', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane 4006, Australia.'}, {'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Skinner', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane 4072, Australia.'}]","Current oncology (Toronto, Ont.)",['10.3390/curroncol29020077']
2320,35201305,Effectiveness of Enhanced Performance Feedback on Appropriate Use of Blood Transfusions: A Comparison of 2 Cluster Randomized Trials.,"Importance


Auditing and feedback are frequently used to improve patient care. However, it remains unclear how to optimize feedback effectiveness for the appropriate use of treatments such as blood transfusion, a common but costly procedure that is more often overused than underused.
Objective


To evaluate 2 theoretically informed feedback interventions to improve the appropriate use of blood transfusions.
Design, Setting, and Participants


Two sequential, linked 2 × 2 cluster randomized trials were performed in hospitals in the UK participating in national audits of transfusion for perioperative anemia and management of hematological disorders. Data were collected for a surgical trial from October 1, 2014, to October 31, 2016, with follow-up completed on October 31, 2016. Data were collected for a hematological trial through follow-up from July 1, 2015, to June 30, 2017. Trial data were analyzed from November 1, 2016, to June 1, 2019.
Interventions


Hospitals were randomized to standard content or enhanced content to improve feedback clarity and usability and to standard support or enhanced support for staff to act on feedback.
Main Outcomes and Measures


The primary end point was appropriateness of transfusions audited at 12 months. Secondary end points included volume of transfusions (aiming for reductions at patient and cluster levels) and transfusion-related adverse events and reactions.
Results


One hundred thirty-five of 152 eligible clusters participated in the surgical audit (2714 patients; mean [SD] age, 74.9 [14.0] years; 1809 women [66.7%]), and 134 of 141 participated in the hematological audit (4439 patients; median age, 72.0 [IQR, 64.0-80.0] years; 2641 men [59.5%]). Fifty-seven of 69 clusters (82.6%) in the surgical audit randomized to enhanced content downloaded reports compared with 52 of 66 clusters (78.8%) randomized to standard reports. Fifty-nine of 68 clusters (86.8%) randomized to enhanced support logged onto the toolkit. The proportion of patients with appropriate transfusions was 0.184 for standard content and 0.176 for enhanced content (adjusted odds ratio [OR], 0.91 [97.5% CI, 0.61-1.36]) and 0.181 for standard support and 0.180 for enhanced support (adjusted OR, 1.05 [97.5% CI, 0.68-1.61]). For the hematological audit, 53 of 66 clusters (80.3%) randomized to enhanced content downloaded the reports compared with 53 of 68 clusters (77.9%) randomized to standard content. Forty-nine of 67 clusters sites (73.1%) assigned to enhanced support logged into the toolkit at least once. The proportion of patients with appropriate transfusions was 0.744 for standard content and 0.714 for enhanced content (adjusted OR, 0.81 [97.5% CI, 0.56-1.12]), and 0.739 for standard support and 0.721 for enhanced support (adjusted OR, 0.96 [97.5% CI, 0.67-1.38]).
Conclusions and Relevance


This comparison of cluster randomized trials found that interventions to improve feedback usability and guide local action were no more effective than standard feedback in increasing the appropriate use of blood transfusions. Auditing and feedback delivered at scale is a complex and costly program; therefore, effective responses may depend on developing robust local quality improvement arrangements, which can be evaluated using rigorous experimental designs embedded within national programs.
Trial Registration


isrctn.org Identifier: ISRCTN15490813.",2022,"The proportion of patients with appropriate transfusions was 0.744 for standard content and 0.714 for enhanced content (adjusted OR, 0.81 [97.5% CI, 0.56-1.12]), and 0.739 for standard support and 0.721 for enhanced support (adjusted OR, 0.96 [97.5% CI, 0.67-1.38]).
","['Fifty-nine of 68 clusters (86.8%) randomized to enhanced support logged onto the toolkit', 'One hundred thirty-five of 152 eligible clusters participated in the surgical audit (2714 patients; mean [SD] age, 74.9 [14.0] years; 1809 women [66.7%]), and 134 of 141 participated in the hematological audit (4439 patients; median age, 72.0 [IQR, 64.0-80.0] years; 2641 men [59.5', 'Participants\n\n\nTwo sequential, linked 2 × 2 cluster randomized trials were performed in hospitals in the UK participating in national audits of transfusion for perioperative anemia and management of hematological disorders', 'Trial data were analyzed from November 1, 2016, to June 1, 2019']","['Enhanced Performance Feedback', 'standard content or enhanced content to improve feedback clarity and usability and to standard support or enhanced support for staff to act on feedback']","['volume of transfusions (aiming for reductions at patient and cluster levels) and transfusion-related adverse events and reactions', 'feedback usability and guide local action']","[{'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0441472', 'cui_str': 'Action'}]",4439.0,0.0555317,"The proportion of patients with appropriate transfusions was 0.744 for standard content and 0.714 for enhanced content (adjusted OR, 0.81 [97.5% CI, 0.56-1.12]), and 0.739 for standard support and 0.721 for enhanced support (adjusted OR, 0.96 [97.5% CI, 0.67-1.38]).
","[{'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Stanworth', 'Affiliation': 'NHS Blood and Transplant, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Walwyn', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Grant-Casey', 'Affiliation': 'NHS Blood and Transplant, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Moreau', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Lorencatto', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, London, United Kingdom.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Francis', 'Affiliation': 'School of Health Sciences City, University of London, London, United Kingdom.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Gould', 'Affiliation': 'School of Health Sciences City, University of London, London, United Kingdom.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Swart', 'Affiliation': 'Department of Applied Health Research, University College London, London, United Kingdom.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rowley', 'Affiliation': 'Scottish National Blood Transfusion Service, Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Grimshaw', 'Affiliation': 'Faculty of Medicine, University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Robbie', 'Initials': 'R', 'LastName': 'Foy', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2022.0364']
2321,35201290,Palliative Radiation for Advanced Central Lung Tumors With Intentional Avoidance of the Esophagus (PROACTIVE): A Phase 3 Randomized Clinical Trial.,"Importance


Palliative thoracic radiotherapy (RT) can alleviate local symptoms associated with advanced non-small cell lung cancer (NSCLC), but esophagitis is a common treatment-related adverse event. Whether esophageal-sparing intensity-modulated RT (ES-IMRT) achieves a clinically relevant reduction in esophageal symptoms remains unclear.
Objective


To examine whether ES-IMRT achieves a clinically relevant reduction in esophageal symptoms compared with standard RT.
Design, Setting, and Participants


Palliative Radiation for Advanced Central Lung Tumors With Intentional Avoidance of the Esophagus (PROACTIVE) is a multicenter phase 3 randomized clinical trial that enrolled patients between June 24, 2016, and March 6, 2019. Data analysis was conducted from January 23, 2020, to October 22, 2021. Patients had up to 1 year of follow-up. Ninety patients at 6 tertiary academic cancer centers who had stage III/IV NSCLC and were eligible for palliative thoracic RT (20 Gy in 5 fractions or 30 Gy in 10 fractions) were included.
Interventions


Patients were randomized (1:1) to standard RT (control arm) or ES-IMRT. Target coverage was compromised to ensure the maximum esophagus dose was no more than 80% of the RT prescription dose.
Main Outcomes and Measures


The primary outcome was esophageal quality of life (QOL) 2 weeks post-RT, measured by the esophageal cancer subscale (ECS) of the Functional Assessment of Cancer Therapy: Esophagus questionnaire. Higher esophageal cancer subscale scores correspond with improved QOL, with a 2- to 3-point change considered clinically meaningful. Secondary outcomes included overall survival, toxic events, and other QOL metrics. Intention-to-treat analysis was used.
Results


Between June 24, 2016, and March 6, 2019, 90 patients were randomized to standard RT or ES-IMRT (median age at randomization, 72.0 years [IQR, 65.6-80.3]; 50 [56%] were female). Thirty-six patients (40%) received 20 Gy and 54 (60%) received 30 Gy. For the primary end point, the mean (SD) 2-week ECS score was 50.5 (10.2) in the control arm (95% CI, 47.2-53.8) and 54.3 (7.6) in the ES-IMRT arm (95% CI, 51.9-56.7) (P = .06). Symptomatic RT-associated esophagitis occurred in 24% (n = 11) of patients in the control arm vs 2% (n = 1) in the ES-IMRT arm (P = .002). In a post hoc subgroup analysis based on the stratification factor, reduction in esophagitis was most evident in patients receiving 30 Gy (30% [n = 8] vs 0%; P = .004). Overall survival was similar with standard RT (median, 8.6; 95% CI, 5.7-15.6 months) and ES-IMRT (median, 8.7; 95% CI, 5.1-10.2 months) (P = .62).
Conclusions and Relevance


In this phase 3 randomized clinical trial, ES-IMRT did not significantly improve esophageal QOL but significantly reduced the incidence of symptomatic esophagitis. Because post hoc analysis found that reduced esophagitis was most evident in patients receiving 30 Gy of RT, these findings suggest that ES-IMRT may be most beneficial when the prescription dose is higher (30 Gy).
Trial Registration


ClinicalTrials.gov Identifier: NCT02752126.",2022,"Overall survival was similar with standard RT (median, 8.6; 95% CI, 5.7-15.6 months) and ES-IMRT (median, 8.7; 95% CI, 5.1-10.2 months)","['enrolled patients between June 24, 2016, and March 6, 2019', 'January 23, 2020, to October 22, 2021', 'Results\n\n\nBetween June 24, 2016, and March 6, 2019, 90 patients were randomized to standard RT or ES-IMRT (median age at randomization, 72.0 years [IQR, 65.6-80.3]; 50 [56%] were female', 'Ninety patients at 6 tertiary academic cancer centers who had stage III/IV NSCLC and were eligible for palliative thoracic RT (20 Gy in 5 fractions or 30 Gy in 10 fractions) were included', 'Advanced Central Lung Tumors With Intentional Avoidance of the Esophagus (PROACTIVE']","['esophageal-sparing intensity-modulated RT (ES-IMRT', 'standard RT (control arm) or ES-IMRT', 'Palliative Radiation', 'Palliative thoracic radiotherapy (RT', 'ES-IMRT']","['Overall survival', 'Symptomatic RT-associated esophagitis', 'overall survival, toxic events, and other QOL metrics', 'esophageal QOL', 'reduced esophagitis', 'Higher esophageal cancer subscale scores', 'esophageal quality of life (QOL) 2 weeks post-RT, measured by the esophageal cancer subscale (ECS) of the Functional Assessment of Cancer Therapy: Esophagus questionnaire', 'symptomatic esophagitis', 'stratification factor, reduction in esophagitis', 'mean (SD) 2-week ECS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024121', 'cui_str': 'Neoplasm of lung'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",90.0,0.38381,"Overall survival was similar with standard RT (median, 8.6; 95% CI, 5.7-15.6 months) and ES-IMRT (median, 8.7; 95% CI, 5.1-10.2 months)","[{'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Louie', 'Affiliation': 'Department of Oncology, Western University, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Patrick V', 'Initials': 'PV', 'LastName': 'Granton', 'Affiliation': 'Department of Radiotherapy, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Alysa', 'Initials': 'A', 'LastName': 'Fairchild', 'Affiliation': 'Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bezjak', 'Affiliation': 'Department of Radiation Oncology, University of Toronto, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Darin', 'Initials': 'D', 'LastName': 'Gopaul', 'Affiliation': 'Grand River Regional Cancer Centre, Kitchener, Ontario, Canada.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Mulroy', 'Affiliation': 'Department of Radiation Oncology, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Brade', 'Affiliation': 'Department of Radiation Oncology, University of Toronto, Credit Valley Cancer Centre, Mississauga, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Department of Oncology, Western University, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Brock', 'Initials': 'B', 'LastName': 'Debenham', 'Affiliation': 'Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bowes', 'Affiliation': 'Department of Radiation Oncology, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Joda', 'Initials': 'J', 'LastName': 'Kuk', 'Affiliation': 'Grand River Regional Cancer Centre, Kitchener, Ontario, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, University of Toronto, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hoover', 'Affiliation': 'Department of Oncology, Western University, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Oncology, Western University, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': 'Department of Oncology, Western University, London Health Sciences Centre, London, Ontario, Canada.'}]",JAMA oncology,['10.1001/jamaoncol.2021.7664']
2322,35202058,The Effect of a Handball Warm-Up Program on Dynamic Balance among Elite Adolescent Handball Players.,"This study examined the effect of the handball warm-up program (HWP) on dynamic balance among elite adolescent handball players. In this case, 24 handball players were randomly assigned into experimental warm-up and control groups. The HWP was performed over 8 weeks (3 times per week). Dynamic balance before and after the intervention training programs were measured by the Biodex Balance System (BBS) and Y Balance test for the dominant (DL) and non-dominant legs (non-DL). After HWP training, BBS scores significantly improved in the overall (OSI) (30.4% and 31.1%), anterior-posterior (APSI) (44.6% and 35.2%), and medial-lateral stability indexes (MLSI) (38.8% and 43%) for both DL and non-DL. Post-training, the Y Balance test exhibited significant improvements in OSI (13.2% and 10.6%), anterior (17.2% and 12.6%), posteriolateral (12.8% and 11.3%), and posteriomedial stability indexes (9.2% and 7.9%) with DL and non-DL, respectively. In conclusion, dynamic balance improved overall after eight weeks of the HWP, with this improvement significantly greater with the trained versus the control group. Optimal balance during handball is an important factor to ensure coordinated and efficient movements and it is speculated that improved balance could positively impact injury prevention. Hence, the HWP program can be used as an alternative to a conventional warm-up program.",2022,"After HWP training, BBS scores significantly improved in the overall (OSI) (30.4% and 31.1%), anterior-posterior (APSI) (44.6% and 35.2%), and medial-lateral stability indexes (MLSI) (38.8% and 43%) for both DL and non-DL. Post-training, the Y Balance test exhibited significant improvements in OSI (13.2% and 10.6%), anterior (17.2% and 12.6%), posteriolateral (12.8% and 11.3%), and posteriomedial stability indexes (9.2% and 7.9%) with DL and non-DL, respectively.","['elite adolescent handball players', '24 handball players', 'Elite Adolescent Handball Players']","['handball warm-up program (HWP', 'Handball Warm-Up Program']","['anterior-posterior (APSI', 'OSI', 'Biodex Balance System (BBS) and Y Balance test', 'posteriomedial stability indexes', 'BBS scores', 'medial-lateral stability indexes (MLSI', 'Dynamic Balance']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0336936', 'cui_str': 'Handball'}]","[{'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",,0.0143075,"After HWP training, BBS scores significantly improved in the overall (OSI) (30.4% and 31.1%), anterior-posterior (APSI) (44.6% and 35.2%), and medial-lateral stability indexes (MLSI) (38.8% and 43%) for both DL and non-DL. Post-training, the Y Balance test exhibited significant improvements in OSI (13.2% and 10.6%), anterior (17.2% and 12.6%), posteriolateral (12.8% and 11.3%), and posteriomedial stability indexes (9.2% and 7.9%) with DL and non-DL, respectively.","[{'ForeName': 'Abdolhamid', 'Initials': 'A', 'LastName': 'Daneshjoo', 'Affiliation': 'Department of Sport Injuries and Corrective Exercises, Faculty of Sport Sciences, Shahid Bahonar University of Kerman, Kerman 76169-13439, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hoseinpour', 'Affiliation': 'Department of Sport Injuries and Corrective Exercises, Faculty of Sport Sciences, Shahid Bahonar University of Kerman, Kerman 76169-13439, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Biomechanics and Sport Injuries, Faculty of Physical Education and Sport Sciences, Kharazmi University, Tehran 15719-14911, Iran.'}, {'ForeName': 'Aref', 'Initials': 'A', 'LastName': 'Kalantari', 'Affiliation': 'Department of Sport Injuries and Corrective Exercises, Faculty of Sport Sciences, Shahid Bahonar University of Kerman, Kerman 76169-13439, Iran.'}, {'ForeName': 'David George', 'Initials': 'DG', 'LastName': 'Behm', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, NL A1C 5S7, Canada.""}]","Sports (Basel, Switzerland)",['10.3390/sports10020018']
2323,35202055,The Effect of Different Periodization and Modes of Concurrent Strength and Endurance Training on Double Poling Performance and Body Composition in Adolescent Cross-Country Skiers.,"The aim of the study was to compare the effects of different types and periodization of strength training on body composition and maximal aerobic performance in 10-week training period in adolescent XC skiers. Twenty-eight adolescent competitive cross-country skiers, including 10 females (age 17.9 ± 1.8 years; body mass 69.6 ± 9.7 kg; height 1.77 ± 0.1 m; training experience 8.6 ± 3.2 years) took part in this study. Pre-and post-intervention performance was measured with the incremental exercise test (Pmax) on a double poling ski ergometer. Changes in body composition were measured with DXA. In addition to regular endurance training, experimental group one (EXP1) performed maximal and explosive strength training two times per week, experimental group two (EXP2) performed maximal and explosive strength training 1-3 times per week, and the traditional (TRAD) group performed low intensity-high volume strength training 2 times per week. Increases in arm, trunk, and overall lean mass were found in TRAD ( p  < 0.05). Increases in arm lean-mass was found in EXP1 ( p  < 0.05), while no changes in body composition occurred in EXP2 ( p  ≥ 0.05). Pmax improved significantly in all groups ( p  < 0.05). Changes in body mass, overall and arm lean mass was related to changes in absolute performance (W;  p  < 0.05), while no relationships were found between changes in body composition parameters and relative performance (W/kg;  p  ≥ 0.05). In conclusion, different periodization of strength training led to similar improvements in double poling ergometer performance, but resulted in different changes in body composition (lean mass) in adolescent cross-country skiers.",2022,"Changes in body mass, overall and arm lean mass was related to changes in absolute performance (W;  p  < 0.05), while no relationships were found between changes in body composition parameters and relative performance (W/kg;  p  ≥ 0.05).","['Adolescent Cross-Country Skiers', 'body mass 69.6 ± 9.7 kg; height 1.77 ± 0.1 m; training experience 8.6 ± 3.2 years) took part in this study', 'Twenty-eight adolescent competitive cross-country skiers, including 10 females (age 17.9 ± 1.8 years', 'adolescent XC skiers']","['regular endurance training, experimental group one (EXP1) performed maximal and explosive strength training two times per week, experimental group two (EXP2) performed maximal and explosive strength training 1-3 times per week, and the traditional (TRAD) group performed low intensity-high volume strength training', 'incremental exercise test (Pmax) on a double poling ski ergometer', 'strength training', 'Different Periodization and Modes of Concurrent Strength and Endurance Training']","['Changes in body mass, overall and arm lean mass', 'body composition', 'overall lean mass', 'Pmax', 'body composition and maximal aerobic performance', 'body composition parameters and relative performance']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0425040', 'cui_str': 'Skier'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068742', 'cui_str': '1.8'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015330', 'cui_str': 'Explosive device'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0337815', 'cui_str': 'Poles'}, {'cui': 'C0037262', 'cui_str': 'SKI'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",28.0,0.00766181,"Changes in body mass, overall and arm lean mass was related to changes in absolute performance (W;  p  < 0.05), while no relationships were found between changes in body composition parameters and relative performance (W/kg;  p  ≥ 0.05).","[{'ForeName': 'Eno', 'Initials': 'E', 'LastName': 'Vahtra', 'Affiliation': 'Institute of Sport Sciences and Physiotherapy, Faculty of Medicine, University of Tartu, 51008 Tartu, Estonia.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Pind', 'Affiliation': 'Institute of Sport Sciences and Physiotherapy, Faculty of Medicine, University of Tartu, 51008 Tartu, Estonia.'}, {'ForeName': 'Evelin', 'Initials': 'E', 'LastName': 'Mäestu', 'Affiliation': 'Institute of Sport Sciences and Physiotherapy, Faculty of Medicine, University of Tartu, 51008 Tartu, Estonia.'}, {'ForeName': 'Priit', 'Initials': 'P', 'LastName': 'Purge', 'Affiliation': 'Institute of Sport Sciences and Physiotherapy, Faculty of Medicine, University of Tartu, 51008 Tartu, Estonia.'}, {'ForeName': 'Priit', 'Initials': 'P', 'LastName': 'Kaasik', 'Affiliation': 'Institute of Sport Sciences and Physiotherapy, Faculty of Medicine, University of Tartu, 51008 Tartu, Estonia.'}, {'ForeName': 'Jarek', 'Initials': 'J', 'LastName': 'Mäestu', 'Affiliation': 'Institute of Sport Sciences and Physiotherapy, Faculty of Medicine, University of Tartu, 51008 Tartu, Estonia.'}]","Sports (Basel, Switzerland)",['10.3390/sports10020015']
2324,35202019,A Pilot Randomized Control Trial to Assess the Impact of Lavender on Anxiety and Comfort After Cesarean Birth and the Barriers Encountered.,,2022,,[],['Lavender'],['Anxiety and Comfort'],[],"[{'cui': 'C0524903', 'cui_str': 'Lavender'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0907305,,[],MCN. The American journal of maternal child nursing,['10.1097/NMC.0000000000000807']
2325,35202010,A Pilot Randomized Control Trial to Assess the Impact of Lavender on Anxiety and Comfort After Cesarean Birth and the Barriers Encountered.,"PURPOSE


This study aimed to assess the effect of lavender aromatherapy on anxiety and comfort after cesarean birth.
STUDY DESIGN


Randomized control trial.
METHODS


Forty-eight patients who had a cesarean birth were asked to complete the six-item State and Trait Anxiety (STAI-6) score to assess their level of anxiety pre- and postapplication of either lavender aromatherapy or placebo during their inpatient postpartum stay. Their comfort and pain levels pre- and postadministration were assessed, and differences between groups were analyzed. Results: There was no difference in postintervention STAI-6 scores between the aromatherapy and placebo groups (p = .56). Women who received the lavender aromatab® had significantly (p = .037) higher self-reported levels of comfort (M 2.6 SD .82) when compared with those who received placebo (M 2.0 SD 1.0).
CLINICAL IMPLICATIONS


Many women use aromatherapy at home to promote comfort and relaxation. Women feel lavender aromatherapy improves their comfort in the hospital setting after cesarean birth. Clinicians should consider ways to safely use aromatherapy as one option to promote postoperative cesarean birth care.",2022,"Women who received the lavender aromatab® had significantly (p = .037) higher self-reported levels of comfort (M 2.6 SD .82) when compared with those who received placebo (M 2.0 SD 1.0).
","['Forty-eight patients who had a cesarean birth', 'hospital setting after cesarean birth']","['placebo', 'Lavender', 'lavender aromatherapy', 'lavender aromatab®', 'lavender aromatherapy or placebo']","['anxiety and comfort', 'self-reported levels of comfort', 'postintervention STAI-6 scores', 'Anxiety and Comfort']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",48.0,0.119685,"Women who received the lavender aromatab® had significantly (p = .037) higher self-reported levels of comfort (M 2.6 SD .82) when compared with those who received placebo (M 2.0 SD 1.0).
","[{'ForeName': 'Adriane', 'Initials': 'A', 'LastName': 'Burgess', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wheeling', 'Affiliation': ''}]",MCN. The American journal of maternal child nursing,['10.1097/NMC.0000000000000803']
2326,35202432,The role of probiotics in children with autism spectrum disorders: A study protocol for a randomised controlled trial.,"BACKGROUND


Autism spectrum disorder (ASD) is a neurological and developmental condition that begins in infancy or earlier and lasts through the individual's lifetime. The aetiology and mechanisms of ASD are not yet fully understood, and current treatment comprises mainly education and rehabilitation, without significant improvement in the core symptoms. Recent studies suggest that microbiota change in children with ASD after the ingestion of probiotics may improve the balance of microbiota and thus ASD symptoms.
OBJECTIVE


The objectives of this study are to evaluate the efficacy of probiotics on the symptoms of children with ASD and the possible mechanisms involved.
METHODS


This is a prospective controlled trial. A total of 160 children with ASD will be stratified and allocated to placebo and probiotics groups randomised according to the severity of their ASD symptoms. The probiotics group will be given probiotics supplements orally twice a day for 3 months and the control group will be given a placebo at the same amount, in addition to the baseline therapy of education and rehabilitation. All the children will be evaluated systematically by using different scales, questionnaires before, during, and after 3 months' treatment, as well as 3 months after discontinuation. The potential impact of probiotics on immunity and inflammation, metabolism, and metagenome will also be investigated.
DISCUSSION


Our previous study showed that the abundance of intestinal flora was greatly different in children with ASD, and that Bifidobacterium was associated with the severity of ASD. In the present study, we will investigate the impact of probiotics supplementation on the symptoms of Children with ASD, with the purpose of evaluating the possible therapeutic effects of additives on ASD and of providing a reference for clinical treatment. The results will help to disclose as yet unknown relationship between probiotics and ASD.
TRIAL REGISTRATION


This study has been registered with Chinese Clinical Trial Registry (ChiCTR-2000037941).",2022,A total of 160 children with ASD will be stratified and allocated to placebo and probiotics groups randomised according to the severity of their ASD symptoms.,"['children with autism spectrum disorders', 'children with ASD', 'Children with ASD', '160 children with ASD', 'Autism spectrum disorder (ASD']","['probiotics supplementation', 'probiotics', 'placebo']",['abundance of intestinal flora'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",160.0,0.149881,A total of 160 children with ASD will be stratified and allocated to placebo and probiotics groups randomised according to the severity of their ASD symptoms.,"[{'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury and Henan Clinical Research Center for Child Neurological Disorders, Institute of Neuroscience and The Third Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury and Henan Clinical Research Center for Child Neurological Disorders, Institute of Neuroscience and The Third Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury and Henan Clinical Research Center for Child Neurological Disorders, Institute of Neuroscience and The Third Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Bingbing', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury and Henan Clinical Research Center for Child Neurological Disorders, Institute of Neuroscience and The Third Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Guiqin', 'Initials': 'G', 'LastName': 'Duan', 'Affiliation': 'Center for Child Behavioral Development, The Third Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Changlian', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury and Henan Clinical Research Center for Child Neurological Disorders, Institute of Neuroscience and The Third Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}]",PloS one,['10.1371/journal.pone.0263109']
2327,35202418,Leukocyte telomere length as a compensatory mechanism in vitamin D metabolism.,"Vitamin D deficiency is common among postmenopausal women. Telomere length can be a potential protective mechanism for age-related diseases. The objective of our study is to examine the association of vitamin D supplementation on leukocyte telomere length (LTL) in healthy postmenopausal women with vitamin D deficiency. The study was designed as a placebo-controlled study to investigate the short-term effects of vitamin D supplementation and seasonal changes on vitamin D related parameters, including 25(OH)D, 1,25(OH)2D parathormone (PTH), Vitamin D binding protein (VDBP), vitamin D receptor (VDR), and telomere length in a cohort of postmenopausal women (n = 102). The group was divided as supplementation (n = 52) and placebo groups (n = 50). All parameters were measured before and after treatment. Serum VDBP levels were measured by ELISA method and VDR, GC (VDBP) gene expressions and relative telomere lengths were measured in peripheral blood mononuclear cells (PBMC) using a quantitative real-time PCR method. The results demonstrate that baseline levels were similar between the groups. After vitamin D supplementation 25(OH)D, 1,25(OH)2D, PTH and VDBP levels were changed significantly compared to the placebo group. At the end of the study period, LTL levels were significantly increased in both groups and this change was more prominent in placebo group. The change in GC expression was significant between treatment and placebo groups but VDR expression remained unchanged. Even though the study was designed to solely assess the effects of vitamin D supplementation, LTL was significantly increased in the whole study group in summer months suggesting that LTL levels are affected by sun exposure and seasonal changes rather than supplementation. The study displayed the short-term effect of Vitamin D supplementation on vitamin D, PTH levels, LTL and vitamin D associated gene expressions. The relation between Vitamin D and LTL is not linear and could be confounded by several factors such as the population differences, regional and seasonal changes in sun exposure.",2022,"At the end of the study period, LTL levels were significantly increased in both groups and this change was more prominent in placebo group.","['postmenopausal women', 'healthy postmenopausal women with vitamin D deficiency', 'postmenopausal women (n = 102']","['Vitamin D and LTL', 'placebo', 'Vitamin D deficiency', 'vitamin D supplementation', 'Vitamin D supplementation']","['vitamin D, PTH levels, LTL and vitamin D associated gene expressions', 'vitamin D related parameters, including 25(OH)D, 1,25(OH)2D parathormone (PTH), Vitamin D binding protein (VDBP), vitamin D receptor (VDR), and telomere length', 'ELISA method and VDR, GC (VDBP) gene expressions and relative telomere lengths', 'peripheral blood mononuclear cells (PBMC', 'VDR expression', 'leukocyte telomere length (LTL', 'LTL levels', 'GC expression', '1,25(OH)2D, PTH and VDBP levels', 'Serum VDBP levels']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042872', 'cui_str': 'GC globulin'}, {'cui': 'C0108082', 'cui_str': 'Vitamin D3 Receptor'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}]",102.0,0.226261,"At the end of the study period, LTL levels were significantly increased in both groups and this change was more prominent in placebo group.","[{'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Agirbasli', 'Affiliation': 'Department of Medical Genetics, Cerrahpaşa Faculty of Medicine, Istanbul University-Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Minenur', 'Initials': 'M', 'LastName': 'Kalyoncu', 'Affiliation': 'Department of Medical Biotechnology, Institute of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Muftuoglu', 'Affiliation': 'Department of Medical Biotechnology, Institute of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.'}, {'ForeName': 'Fehime Benli', 'Initials': 'FB', 'LastName': 'Aksungar', 'Affiliation': 'Department of Biochemistry, School of Medicine, Mehmet Ali Aydinlar University, Istanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Agirbasli', 'Affiliation': 'Department of Cardiology, T.C Istanbul Medeniyet University, School of Medicine, Ministry of Health, Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul, Turkey.'}]",PloS one,['10.1371/journal.pone.0264337']
2328,35202361,Bonded amalgam as a fissure sealant in low-income setting: A randomised controlled trial.,"Objectives


To compare one year retention rate of bonded amalgam sealants (BAS) with that of conventional resin-based sealant (RBS).
METHODS


It was a parallel group, equivalence, randomised controlled trial done during March 2018 to December 2019 at the dental clinics of Dow University of Health Sciences, and the Jinnah Sind Medical University, Karachi, Pakistan on children aged 12-16 years, who were randomly assigned to one of the two treatment groups (BAS vs. RBS). Complete retention of the sealant at one year follow-up was labeled as success. Multi-level mixed effect logistic regression model was employed. Study was registered at www.clinicaltrials.gov # NCT NCT03130725.
RESULTS


There were 137 teeth (23 subjects) in the BAS and 128 teeth (15 subjects) in the RBS group that were evaluated for sealant retention at 12 months follow-up. Among the BAS group, 100/137 (73%) sealants were completely retained whereas 110/128 (86%) were fully retained in the RBS group. Nearly, 22/137 (16%) BAS and 10/128 (7.8%) RBS were completely dislodged. In multivariable analysis, subject age >15 years and male gender were found to be significantly associated with the dislodgement of sealants.
CONCLUSIONS


At 12 months follow-up, the retention of bonded amalgam sealant (BAS) was significantly lower than that of the resin-based sealant (RBS).
RCT Registration


www.clinicaltrials.gov with # NCT NCT03130725.",2022,"At 12 months follow-up, the retention of bonded amalgam sealant (BAS) was significantly lower than that of the resin-based sealant (RBS).
","['low-income setting', 'March 2018 to December 2019 at the dental clinics of Dow University of Health Sciences, and the Jinnah Sind Medical University, Karachi, Pakistan on children aged 12-16 years', 'There were 137 teeth (23 subjects) in the BAS and 128 teeth (15 subjects) in the RBS group']","['conventional resin-based sealant (RBS', 'bonded amalgam sealants (BAS']","['Complete retention', 'RBS', 'retention of bonded amalgam sealant (BAS', 'dislodgement of sealants', 'sealant retention']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0011344', 'cui_str': 'Dental clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0440138', 'cui_str': 'Amalgam (silver) dental filling material'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0440138', 'cui_str': 'Amalgam (silver) dental filling material'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0440138', 'cui_str': 'Amalgam (silver) dental filling material'}]",,0.15003,"At 12 months follow-up, the retention of bonded amalgam sealant (BAS) was significantly lower than that of the resin-based sealant (RBS).
","[{'ForeName': 'Farhan Raza', 'Initials': 'FR', 'LastName': 'Khan', 'Affiliation': 'Operative Dentistry, Aga Khan University Hospital, Karachi.'}, {'ForeName': 'Samreen', 'Initials': 'S', 'LastName': 'Liaquat', 'Affiliation': 'Department of Clinical Research, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Ghazala', 'Initials': 'G', 'LastName': 'Rafique', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Syed Iqbal', 'Initials': 'SI', 'LastName': 'Azam', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Arshad', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Operative Dentistry, Dow Dental College, Dow University of Health Sciences, Karachi, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.47391/JPMA.AKU-02']
2329,35202353,"Interim Guidance: 4-Month Rifapentine-Moxifloxacin Regimen for the Treatment of Drug-Susceptible Pulmonary Tuberculosis - United States, 2022.","On May 5, 2021, CDC's Tuberculosis Trials Consortium and the National Institutes of Health (NIH)-sponsored AIDS Clinical Trials Group (ACTG) published results from a randomized controlled trial indicating that a 4-month regimen containing rifapentine (RPT), moxifloxacin (MOX), isoniazid (INH), and pyrazinamide (PZA) was as effective as the standard 6-month regimen for tuberculosis (TB) treatment (1). On the basis of these findings, CDC recommends the 4-month regimen as a treatment option for U.S. patients aged ≥12 years with drug-susceptible pulmonary TB and provides implementation considerations for this treatment regimen.",2022,"On May 5, 2021, CDC's Tuberculosis Trials Consortium and the National Institutes of Health (NIH)-sponsored AIDS Clinical Trials Group (ACTG) published results from a randomized controlled trial indicating that a 4-month regimen containing rifapentine (RPT), moxifloxacin (MOX), isoniazid (INH), and pyrazinamide (PZA) was as effective as the standard 6-month regimen for tuberculosis (TB) treatment (1).","['Drug-Susceptible Pulmonary Tuberculosis - United States, 2022', 'U.S. patients aged ≥12 years with drug-susceptible pulmonary TB']","['rifapentine (RPT), moxifloxacin (MOX), isoniazid (INH), and pyrazinamide (PZA', 'Rifapentine-Moxifloxacin']",[],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0073372', 'cui_str': 'rifapentine'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}]",[],,0.149187,"On May 5, 2021, CDC's Tuberculosis Trials Consortium and the National Institutes of Health (NIH)-sponsored AIDS Clinical Trials Group (ACTG) published results from a randomized controlled trial indicating that a 4-month regimen containing rifapentine (RPT), moxifloxacin (MOX), isoniazid (INH), and pyrazinamide (PZA) was as effective as the standard 6-month regimen for tuberculosis (TB) treatment (1).","[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Carr', 'Affiliation': 'Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, CDC.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Kurbatova', 'Affiliation': 'Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, CDC.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Starks', 'Affiliation': 'Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, CDC.'}, {'ForeName': 'Neela', 'Initials': 'N', 'LastName': 'Goswami', 'Affiliation': 'Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, CDC.'}, {'ForeName': 'Leeanna', 'Initials': 'L', 'LastName': 'Allen', 'Affiliation': 'Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, CDC.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Winston', 'Affiliation': 'Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, CDC.'}]",MMWR. Morbidity and mortality weekly report,['10.15585/mmwr.mm7108a1']
2330,35203534,Impact of Adalimumab Treatment on Interleukin-17 and Interleukin-17 Receptor Expression in Skin and Synovium of Psoriatic Arthritis Patients with Mild Psoriasis.,"Interleukin (IL)-17 and tumor necrosis factor-alpha (TNF)-α are key players in psoriatic arthritis (PsA) pathogenesis. While both cytokines can be therapeutically targeted with beneficial clinical outcome, it is unclear whether inhibiting one cytokine will affect the other at sites of inflammation. If both act independently, this might provide a rationale for dual or combined inhibition of both cytokines. Here, we evaluated the effect of TNF blockade in PsA patients on IL-17 levels in both skin and synovial tissue biopsies. PsA patients with mild psoriatic skin lesions were randomized to receive either adalimumab or placebo for four weeks. Synovial and skin biopsies were obtained at weeks zero and four. Skin from healthy donors (HDs) was used for comparison. Expression of IL-17A, IL-17F, IL-17RA and IL-17RC was assessed by immunohistochemistry and analyzed with digital image analysis. We found relatively low levels of IL-17 and its receptors in the skin of PsA patients compared to HD, and only IL-17F in the dermis of lesional psoriatic skin was significantly higher compared to HD skin ( p  = 0.0002). Histologically IL-17A, IL-17F, IL-17RA and IL-17RC in skin and synovial tissue were not downregulated by adalimumab treatment. Thus, in this cohort of PsA patients with mild psoriasis, TNF blockade did not affect the protein levels of IL-17 cytokines and its receptors in skin and synovium, despite reduced cellular inflammation and improved clinical outcome for joint involvement.",2022,"Expression of IL-17A, IL-17F, IL-17RA and IL-17RC was assessed by immunohistochemistry and analyzed with digital image analysis.","['PsA patients with mild psoriatic skin lesions', 'Skin from healthy donors (HDs', 'PsA patients on IL-17 levels in both skin and synovial tissue biopsies', 'Psoriatic Arthritis Patients with Mild Psoriasis']","['Adalimumab', 'adalimumab or placebo', 'alpha (TNF)-α', 'TNF blockade']","['Expression of IL-17A, IL-17F, IL-17RA and IL-17RC', 'Histologically IL-17A, IL-17F, IL-17RA and IL-17RC in skin and synovial tissue', 'Interleukin (IL)-17 and tumor necrosis factor', 'lesional psoriatic skin', 'Synovial and skin biopsies']","[{'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039099', 'cui_str': 'Synovial membrane'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C1432339', 'cui_str': 'IL17F protein, human'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0039099', 'cui_str': 'Synovial membrane'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0150866', 'cui_str': 'Biopsy of skin'}]",,0.0624211,"Expression of IL-17A, IL-17F, IL-17RA and IL-17RC was assessed by immunohistochemistry and analyzed with digital image analysis.","[{'ForeName': 'Janne W', 'Initials': 'JW', 'LastName': 'Bolt', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Amsterdam Rheumatology & Immunology Center (ARC), Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Arno W', 'Initials': 'AW', 'LastName': 'van Kuijk', 'Affiliation': 'Department of Rheumatology, Amsterdam Rheumatology & Immunology Center (ARC)-Reade, 1040 HG Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel B M', 'Initials': 'MBM', 'LastName': 'Teunissen', 'Affiliation': 'Department of Dermatology, Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'van der Coelen', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Amsterdam Rheumatology & Immunology Center (ARC), Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Saïda', 'Initials': 'S', 'LastName': 'Aarrass', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Amsterdam Rheumatology & Immunology Center (ARC), Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Daniëlle M', 'Initials': 'DM', 'LastName': 'Gerlag', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Amsterdam Rheumatology & Immunology Center (ARC), Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Tak', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Amsterdam Rheumatology & Immunology Center (ARC), Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Marleen G', 'Initials': 'MG', 'LastName': 'van de Sande', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Amsterdam Rheumatology & Immunology Center (ARC), Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Lebre', 'Affiliation': 'The Netherlands Cancer Institute, Division of Pharmacology, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands.'}, {'ForeName': 'Lisa G M', 'Initials': 'LGM', 'LastName': 'van Baarsen', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Amsterdam Rheumatology & Immunology Center (ARC), Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}]",Biomedicines,['10.3390/biomedicines10020324']
2331,35203477,"Different Changes in Adipokines, Lipid Profile, and TNF-Alpha Levels between 10 and 20 Whole Body Cryostimulation Sessions in Individuals with I and II Degrees of Obesity.","Obesity is associated with chronic inflammation. While cold therapy influences the pro/antioxidative status of an individual, by affecting adipokine levels and the lipid profile, the effect of body mass index (BMI) on the response to cold exposure is unclear. We analyzed the link between BMI and the differences in effects of whole-body stimulation, depending on the number of treatments, on specific physiological parameters in men. Twenty-seven non-active men were divided into three groups: N ( n  = 9, BMI < 24.9), IOb ( n  = 9, BMI 30.0-34.9), and IIOb (BMI ≥ 35.0). The subjects participated in 20 3-min cryochamber sessions (-120 °C), 1/day, 5 days/week. Body composition was analyzed before and after treatment. Blood adiponectin (ADP), leptin (LEP), and tumor necrosis factor alpha (TNF-alpha) levels, and the lipid profile were analyzed three times: at baseline and up to 2 h after 10 and 20 sessions. The 20 treatments caused significant changes in body composition. Between 10 and 20 whole-body cryostimulation (WBC) sessions, a significant decreased was observed in the LEP and TNF-alpha levels. No significant changes in the lipid profile were noted. However, a positive tendency to regain the metabolic balance in adipose tissue was apparent in the IOb group in the tested period (decreased TG levels, increased HDL levels or the HDL/LDL ratio, and significantly decreased visceral adiposity index levels). Collectively, for people with obesity increasing the number of treatments above the standard 10 should be recommended.",2022,No significant changes in the lipid profile were noted.,"['Twenty-seven non-active men', 'men']",[],"['alpha (TNF-alpha) levels, and the lipid profile', 'Adipokines, Lipid Profile, and TNF-Alpha Levels', 'body composition', 'visceral adiposity index levels', 'metabolic balance in adipose tissue', 'TG levels, increased HDL levels or the HDL/LDL ratio', 'Blood adiponectin (ADP), leptin (LEP), and tumor necrosis factor', 'lipid profile', 'LEP and TNF-alpha levels', 'Body composition']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],"[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0853084', 'cui_str': 'High density lipoprotein increased'}, {'cui': 'C1171408', 'cui_str': 'High density/low density lipoprotein ratio measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]",,0.0142914,No significant changes in the lipid profile were noted.,"[{'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Pilch', 'Affiliation': 'Faculty of Physiotherapy, Institute for Basic Sciences, University of Physical Education, 31-571 Krakow, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Piotrowska', 'Affiliation': 'Faculty of Physiotherapy, Institute for Basic Sciences, University of Physical Education, 31-571 Krakow, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wyrostek', 'Affiliation': 'Institute of Physical Culture, State University of Applied Sciences, 33-300 Nowy Sacz, Poland.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Czerwińska-Ledwig', 'Affiliation': 'Faculty of Physiotherapy, Institute for Basic Sciences, University of Physical Education, 31-571 Krakow, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Ziemann', 'Affiliation': 'Department of Athletics, Strength, and Conditioning, Poznan University of Physical Education, 61-871 Poznan, Poland.'}, {'ForeName': 'Jędrzej', 'Initials': 'J', 'LastName': 'Antosiewicz', 'Affiliation': 'Department of Bioenergetics and Exercise Physiology, Medical University of Gdansk, 80-210 Gdansk, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Zasada', 'Affiliation': 'Department of Biological Foundations of Physical Culture, Kazimierz Wielki University, 85-091 Bydgoszcz, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Kulesa-Mrowiecka', 'Affiliation': 'Department of Rehabilitation in Internal Diseases, Faculty of Health Sciences, Jagiellonian University Medical College, 31-008 Krakow, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Żychowska', 'Affiliation': 'Department of Biological Foundations of Physical Culture, Kazimierz Wielki University, 85-091 Bydgoszcz, Poland.'}]",Biomedicines,['10.3390/biomedicines10020269']
2332,35203417,Comparison of Extracorporeal Shockwave Therapy with Non-Steroid Anti-Inflammatory Drugs and Intra-Articular Hyaluronic Acid Injection for Early Osteoarthritis of the Knees.,"Conservative treatments for early osteoarthritis (OA) of the knee included the use of non-steroid anti-inflammatory drugs (NSAIDs) and intra-articular hyaluronic acid (HA) injection. Recently, several animal studies reported that extracorporeal shockwave therapy (ESWT) demonstrated chondroprotective effects on knee OA. The present study compared the efficacy of oral NSAIDs, HA injection, and noninvasive ESWT for early OA of the knee. Forty-five patients with early knee OA were randomized into three groups. NSAIDs group received celecoxib 200 mg daily for 3 weeks. HA group received intra-articular injection of HA once a week for 3 weeks. ESWT group received ESWT for 3 sessions at bi-weekly interval. All patients were followed up for one year. Evaluations included the visual analogue scale (VAS) score, serum enzyme-linked immunosorbent assay (ELISA), plain radiography, dual-energy X-ray absorptiometry (DEXA), and magnetic resonance imaging (MRI). In addition, the functional scores were performed including, WOMAC (Western Ontario and McMaster Universities Arthritis Index) score, KOOS (knee injury and osteoarthritis outcome) score, and IKDC (International Knee Documentation Committee) score. All three groups showed significant improvement in VAS and functional scores as well as in the collected one-year follow-up data after treatments. ESWT group had better pain relief than NSAIDs and HA groups. ESWT group had better therapeutic effects in the functional scores than NSAIDs and HA groups. The bone mineral density (BMD) of proximal tibia is significantly increased after ESWT than others. In the serum ELISA, ESWT inhibited the expression of COMP in knee OA patients as compared with NSAIDs and HA groups. The parameters of MRI showed no significant differences between three groups after treatments. ESWT and intra-articular HA injection showed comparable results than NSAIDs. ESWT was superior in pain relief than HA and NSAIDs. The results demonstrated that ESWT was an effective and alternative therapy than HA and NSAIDs for early osteoarthritis of the knees.",2022,All three groups showed significant improvement in VAS and functional scores as well as in the collected one-year follow-up data after treatments.,"['early osteoarthritis (OA) of the knee included the use of non', 'Forty-five patients with early knee OA', 'Early Osteoarthritis of the Knees']","['intra-articular injection of HA', 'ESWT', 'oral NSAIDs, HA injection, and noninvasive ESWT', 'celecoxib', 'Extracorporeal Shockwave Therapy with Non-Steroid Anti-Inflammatory Drugs and Intra-Articular Hyaluronic Acid Injection', 'extracorporeal shockwave therapy (ESWT', 'steroid anti-inflammatory drugs (NSAIDs) and intra-articular hyaluronic acid (HA) injection']","['pain relief', 'ESWT and intra-articular', 'visual analogue scale (VAS) score, serum enzyme-linked immunosorbent assay (ELISA), plain radiography, dual-energy X-ray absorptiometry (DEXA), and magnetic resonance imaging (MRI', 'VAS and functional scores', 'bone mineral density (BMD) of proximal tibia', 'expression of COMP', 'WOMAC (Western Ontario and McMaster Universities Arthritis Index) score, KOOS (knee injury and osteoarthritis outcome) score, and IKDC (International Knee Documentation Committee) score']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0588198', 'cui_str': 'Bone structure of proximal tibia'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0056167', 'cui_str': 'COMP protocol'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}]",45.0,0.0117174,All three groups showed significant improvement in VAS and functional scores as well as in the collected one-year follow-up data after treatments.,"[{'ForeName': 'Shun-Wun', 'Initials': 'SW', 'LastName': 'Jhan', 'Affiliation': 'Department of Orthopedic Surgery, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 833, Taiwan.'}, {'ForeName': 'Ching-Jen', 'Initials': 'CJ', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedic Surgery, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 833, Taiwan.'}, {'ForeName': 'Kuan-Ting', 'Initials': 'KT', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedic Surgery, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 833, Taiwan.'}, {'ForeName': 'Ka-Kit', 'Initials': 'KK', 'LastName': 'Siu', 'Affiliation': 'Park One International Hospital, Kaohsiung 833, Taiwan.'}, {'ForeName': 'Jih-Yang', 'Initials': 'JY', 'LastName': 'Ko', 'Affiliation': 'Department of Orthopedic Surgery, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 833, Taiwan.'}, {'ForeName': 'Wen-Chiung', 'Initials': 'WC', 'LastName': 'Huang', 'Affiliation': 'Center for Shockwave Medicine and Tissue Engineering, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 833, Taiwan.'}, {'ForeName': 'Wen-Yi', 'Initials': 'WY', 'LastName': 'Chou', 'Affiliation': 'Department of Orthopedic Surgery, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 833, Taiwan.'}, {'ForeName': 'Jai-Hong', 'Initials': 'JH', 'LastName': 'Cheng', 'Affiliation': 'Center for Shockwave Medicine and Tissue Engineering, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 833, Taiwan.'}]",Biomedicines,['10.3390/biomedicines10020202']
2333,35207414,Carisoprodol Single and Multiple Dose PK-PD. Part II: Pharmacodynamics Evaluation Method for Central Muscle Relaxants. Double-Blind Placebo-Controlled Clinical Trial in Healthy Volunteers.,"Centrally acting skeletal muscle relaxants (CMR) such as carisoprodol are used to treat acute, painful musculoskeletal conditions, though its precise mode of action has not been characterized. A double-blinded, placebo-controlled, randomized clinical trial was designed to evaluate the pharmacokinetics-pharmacodynamics (PKPD) of CMR after single (350 mg), double (700 mg), and multiple doses (up to 350 mg/8 h, 14 days) of carisoprodol. Muscular (Electromyogram-EMG, muscular strength dynamometry), central (sedation), and tolerability (psychomotor activity test, adverse events) parameters, as well as withdrawal symptoms, were evaluated. Thirteen healthy volunteers were enrolled. No evidence of direct muscle relaxation was evidenced, but some differences on sedation were evidenced throughout the study, suggesting that CMRs act, at least partly, through sedation. Most significant differences were detected at 1.5 h after dosing. The effect on psychomotor impairment was variable, most prominently after 1.5 h, too, suggesting that it is produced by carisoprodol rather than by meprobamate. No withdrawal symptoms were detected, so the risk of dependence following maximum doses and duration of treatment recommended, and under medical supervision, should be low.",2022,"No evidence of direct muscle relaxation was evidenced, but some differences on sedation were evidenced throughout the study, suggesting that CMRs act, at least partly, through sedation.","['Thirteen healthy volunteers were enrolled', 'Healthy Volunteers']","['Carisoprodol Single and Multiple Dose PK-PD', 'Placebo', 'Centrally acting skeletal muscle relaxants (CMR', 'placebo']","['direct muscle relaxation', 'psychomotor impairment', 'withdrawal symptoms', 'pharmacokinetics-pharmacodynamics (PKPD', 'Muscular (Electromyogram-EMG, muscular strength dynamometry), central (sedation), and tolerability (psychomotor activity test, adverse events) parameters, as well as withdrawal symptoms']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0007248', 'cui_str': 'Carisoprodol'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0037250', 'cui_str': 'Skeletal muscle relaxant'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0026836', 'cui_str': 'Muscle relaxation'}, {'cui': 'C0424230', 'cui_str': 'Motor retardation'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",13.0,0.255493,"No evidence of direct muscle relaxation was evidenced, but some differences on sedation were evidenced throughout the study, suggesting that CMRs act, at least partly, through sedation.","[{'ForeName': 'Aitana', 'Initials': 'A', 'LastName': 'Calvo', 'Affiliation': 'Clinical Pharmacology Department, Hospital Clínico San Carlos, IdISSC, 28040 Madrid, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'González-Hidalgo', 'Affiliation': 'Clinical Neurophysiology Department, Hospital Clínico San Carlos, IdISSC, 28040 Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Terleira', 'Affiliation': 'Clinical Pharmacology Department, Hospital Clínico San Carlos, IdISSC, 28040 Madrid, Spain.'}, {'ForeName': 'Nieves', 'Initials': 'N', 'LastName': 'Fernández', 'Affiliation': 'Belmac Laboratories, 28700 Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Portolés', 'Affiliation': 'Clinical Pharmacology Department, Hospital Clínico San Carlos, IdISSC, 28040 Madrid, Spain.'}]",Journal of clinical medicine,['10.3390/jcm11041141']
2334,35207411,Melatonin in the Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers (MeCOVID): A Randomised Clinical Trial.,"We evaluated in this randomised, double-blind clinical trial the efficacy of melatonin as a prophylactic treatment for prevention of SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 exposure. Healthcare workers fulfilling inclusion criteria were recruited in five hospitals in Spain and were randomised 1:1 to receive melatonin 2 mg administered orally for 12 weeks or placebo. The main outcome was the number of SARS-CoV-2 infections. A total of 344 volunteers were screened, and 314 were randomised: 151 to placebo and 163 to melatonin; 308 received the study treatment (148 placebo; 160 melatonin). We detected 13 SARS-CoV-2 infections, 2.6% in the placebo arm and 5.5% in the melatonin arm ( p  = 0.200). A total of 294 adverse events were detected in 127 participants (139 in placebo; 155 in melatonin). We found a statistically significant difference in the incidence of adverse events related to treatment: 43 in the placebo arm and 67 in the melatonin arm ( p  = 0.040), and in the number of participants suffering from somnolence related to treatment: 8.8% ( n  = 14) in the melatonin versus 1.4% ( n  = 2) in the placebo arm ( p  = 0.008). No severe adverse events related to treatment were reported. We cannot confirm our hypothesis that administration of melatonin prevents the development of SARS-CoV-2 infection in healthcare workers.",2022,We cannot confirm our hypothesis that administration of melatonin prevents the development of SARS-CoV-2 infection in healthcare workers.,"['healthcare workers at high risk of SARS-CoV-2 exposure', 'Healthcare Workers (MeCOVID', 'Healthcare workers fulfilling inclusion criteria were recruited in five hospitals in Spain', '344 volunteers were screened, and 314 were randomised: 151 to', '127 participants (139 in placebo; 155 in melatonin', 'healthcare workers']","['melatonin', 'placebo', 'Melatonin', 'placebo; 160 melatonin', 'melatonin 2 mg administered orally for 12 weeks or placebo']","['number of SARS-CoV-2 infections', 'incidence of adverse events', 'severe adverse events']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1128359', 'cui_str': 'Melatonin 2 MG'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",344.0,0.799385,We cannot confirm our hypothesis that administration of melatonin prevents the development of SARS-CoV-2 infection in healthcare workers.,"[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'García-García', 'Affiliation': 'Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, 28046 Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Seco-Meseguer', 'Affiliation': 'Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, 28046 Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Ruiz-Seco', 'Affiliation': 'Internal Medicine Department, Infanta Sofía University Hospital, 28702 San Sebastián de los Reyes, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Navarro-Jimenez', 'Affiliation': 'Internal Medicine Department, Infanta Sofía University Hospital, 28702 San Sebastián de los Reyes, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Martínez-Porqueras', 'Affiliation': 'Internal Medicine Department, Hospital Universitario 12 de Octubre, 28041 Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Espinosa-Díaz', 'Affiliation': 'Internal Medicine Department, Hospital Universitario 12 de Octubre, 28041 Madrid, Spain.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Ortega-Albás', 'Affiliation': 'Sleep Unit, Hospital General Universitario de Castellón, 12004 Castellón de la Plana, Spain.'}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Sagastagoitia', 'Affiliation': 'Internal Medicine/Infectious Diseases Department, Hospital Clínico San Carlos, IdiSSC, 28040 Madrid, Spain.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'García-Morales', 'Affiliation': 'Spanish Clinical Research Network (SCReN), 28046 Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Jiménez-González', 'Affiliation': 'Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, 28046 Madrid, Spain.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Martínez de Soto', 'Affiliation': 'Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, 28046 Madrid, Spain.'}, {'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'Bajo-Martínez', 'Affiliation': 'Emergency Department, Infanta Sofía University Hospital, 28702 San Sebastián de los Reyes, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Del Palacio-Tamarit', 'Affiliation': 'Internal Medicine Department, Hospital Universitario 12 de Octubre, 28041 Madrid, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'López-García', 'Affiliation': 'Sleep Unit, Hospital General Universitario de Castellón, 12004 Castellón de la Plana, Spain.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Díaz-García', 'Affiliation': 'Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, 28046 Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Queiruga-Parada', 'Affiliation': 'Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, 28046 Madrid, Spain.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Giesen', 'Affiliation': 'Preventive Medicine Unit, Infanta Sofia University Hospital, 28702 San Sebastián de los Reyes, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pérez-Villena', 'Affiliation': 'Pediatric Department, Infanta Sofia University Hospital, 28702 San Sebastián de los Reyes, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'de Castro-Martínez', 'Affiliation': 'Internal Medicine Department, Hospital Universitario 12 de Octubre, 28041 Madrid, Spain.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'González-García', 'Affiliation': 'Infectious Diseases Unit, La Paz University Hospital-IdiPAZ, 28046 Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Rodriguez-Rubio', 'Affiliation': 'School of Medicine, Universidad Autónoma de Madrid, 28029 Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'de la Oliva', 'Affiliation': 'School of Medicine, Universidad Autónoma de Madrid, 28029 Madrid, Spain.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Arribas', 'Affiliation': 'Infectious Diseases Unit, La Paz University Hospital-IdiPAZ, 28046 Madrid, Spain.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Carcas', 'Affiliation': 'Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, 28046 Madrid, Spain.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Borobia', 'Affiliation': 'Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, 28046 Madrid, Spain.'}]",Journal of clinical medicine,['10.3390/jcm11041139']
2335,35207369,Effect of Transcutaneous Vagus Nerve Stimulation in Erosive Hand Osteoarthritis: Results from a Pilot Trial.,"Beyond its effect on vegetative functions, the activation of the vagus nerve inhibits inflammation and reduces pain signaling. The aim of this open-label pilot study was to determine the efficacy and tolerance of transcutaneous auricular VNS (taVNS) on erosive hand osteoarthritis (EHOA) symptoms. Symptomatic EHOA patients with hand pain VAS ≥ 40/100 mm and ≥1 interphalangeal swollen joint(s) were included. The taVNS was performed for 4 weeks using an auricular electrode applied one hour per day and connected to a TENS device with pre-established settings. Clinical efficacy was evaluated by changes between baseline and at 4 weeks with hand pain VAS and the functional index FIHOA score, using a Wilcoxon  t -test. The treatment tolerance was also evaluated. Eighteen patients (median age 69 years old, 83% women) were analyzed. At baseline, hand pain VAS was 60 mm [IQR 50; 78.2] and FIHOA 15 [10.7; 20.2]. After 4 weeks, taVNS significantly reduced hand pain VAS, with a median decrease of 23.5 mm [7.7; 37.2] ( p  = 0.001), as well as FIHOA, with a median decrease of 2 points [0.75; 5.2] ( p  = 0.01). No serious adverse events were reported. One patient stopped taVNS because of auricular discomfort. This first proof-of-concept trial indicated that taVNS is feasible and may decrease joint inflammation and clinical symptoms in EHOA, arguing for a randomized controlled study versus sham stimulation.",2022,"After 4 weeks, taVNS significantly reduced hand pain VAS, with a median decrease of 23.5 mm [7.7; 37.2] ( p  = 0.001), as well as FIHOA, with a median decrease of 2 points [0.75; 5.2] ( p  = 0.01).","['Eighteen patients (median age 69 years old, 83% women', 'Erosive Hand Osteoarthritis', 'Symptomatic EHOA patients with hand pain VAS ≥ 40/100 mm and ≥1 interphalangeal swollen joint(s']","['taVNS', 'Transcutaneous Vagus Nerve Stimulation', 'transcutaneous auricular VNS (taVNS']","['functional index FIHOA score', 'serious adverse events', 'hand pain VAS', 'Clinical efficacy', 'efficacy and tolerance', 'erosive hand osteoarthritis (EHOA) symptoms']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0239833', 'cui_str': 'Hand pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0239833', 'cui_str': 'Hand pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",83.0,0.0348953,"After 4 weeks, taVNS significantly reduced hand pain VAS, with a median decrease of 23.5 mm [7.7; 37.2] ( p  = 0.001), as well as FIHOA, with a median decrease of 2 points [0.75; 5.2] ( p  = 0.01).","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Courties', 'Affiliation': 'Service de Rhumatologie, Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris (AP-HP), Sorbonne Université, INSERM UMR_S 938, 75012 Paris, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Deprouw', 'Affiliation': 'Service de Rhumatologie, Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris (AP-HP), 75012 Paris, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Maheu', 'Affiliation': 'Service de Rhumatologie, Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris (AP-HP), 75012 Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gibert', 'Affiliation': 'Cabinet de Rhumatologie, 94200 Ivry sur Seine, France.'}, {'ForeName': 'Jacques-Eric', 'Initials': 'JE', 'LastName': 'Gottenberg', 'Affiliation': 'Service de Rhumatologie, Centre National de Référence Pour les Maladies Auto-Immunes Systémiques, Hôpital Universitaire de Strasbourg, Université de Strasbourg, 67200 Strasbourg, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Champey', 'Affiliation': 'Service de Rhumatologie, Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris (AP-HP), 75012 Paris, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Banneville', 'Affiliation': 'Service de Rhumatologie, Hôpital Pitié Salpêtrière, Assistance Publique Hôpitaux de Paris (AP-HP), Sorbonne Université, 75013 Paris, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Chesnel', 'Affiliation': 'GREEN Groupe de Recherche Clinique en Neuro-Urologie, GRC 01, Hôpital Tenon, Assistance Publique Hôpitaux de Paris (AP-HP), Sorbonne Université, 75020 Paris, France.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Amarenco', 'Affiliation': 'GREEN Groupe de Recherche Clinique en Neuro-Urologie, GRC 01, Hôpital Tenon, Assistance Publique Hôpitaux de Paris (AP-HP), Sorbonne Université, 75020 Paris, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Rousseau', 'Affiliation': ""Unité de Recherche Clinique de l'Est Parisien (URC-Est), Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris (AP-HP), Sorbonne Université, 75012 Paris, France.""}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Berenbaum', 'Affiliation': 'Service de Rhumatologie, Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris (AP-HP), Sorbonne Université, INSERM UMR_S 938, 75012 Paris, France.'}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Sellam', 'Affiliation': 'Service de Rhumatologie, Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris (AP-HP), Sorbonne Université, INSERM UMR_S 938, 75012 Paris, France.'}]",Journal of clinical medicine,['10.3390/jcm11041087']
2336,35207356,Changes in Fat Oxidation and Body Composition after Combined Exercise Intervention in Sedentary Obese Chinese Adults.,"(1) Background: Evidence suggests that aerobic exercise and high-intensity interval training (HIIT) might increase fat oxidation and reduce fat. However, limited research has examined the effects of combining progressive aerobic exercise and HIIT interventions in sedentary adults with overweight and obesity, and differences in its effects between men and women remain unclear. The purpose of this study was to investigate the effects of combined progressive aerobic exercise and HIIT (CAEH) on fat oxidation and fat reduction in sedentary Chinese adults and compare sex differences in sedentary adults after seven weeks. (2) Methods: Eighty-four sedentary obese adults were enrolled and allocated to two groups in baseline (experimental (EXP) group:42; control (CON) group:42), and fifty-six subjects (EXP:31; CON:25) completed the experiments and were included in the final analysis. Subjects in the EXP group performed CAEH three times per week for seven weeks. Subjects in the CON group were advised to continue with their normal daily activities. Anthropometric, lipid profile, cardiorespiratory fitness, and fat oxidation outcomes were assessed before and after the intervention. (3) Results: After seven weeks of the CAEH intervention, compared with the CON group, the EXP group showed significant increases in fat oxidation at rest (FO_rest) (+0.03 g/min,  p  < 0.01), maximal fat oxidation (MFO) (+0.05 g/min,  p  < 0.01), and maximal oxygen intake (VO 2 max) (+3.2 mL/kg/min,  p  < 0.01). The changes in the percentages of the FO_rest (+57%) and the VO 2 max (+16%) were significantly greater (+20%, +6%) in males than in females ( p  < 0.05,  p  < 0.05). The body mass index (BMI) (-1.2 kg/m 2 ,  p  < 0.01), body fat percentage (-3.2%,  p  < 0.001), visceral fat area (-12.8 cm 2 ,  p  < 0.001), and total cholesterol (TC) levels (-0.4 mmol/L,  p  < 0.05) were significantly decreased in the EXP group. (4) Conclusions: Seven weeks of the CAEH intervention effectively improved FO_rest, MFO, and VO 2 max in sedentary obese adults, and the improvements in FO_rest and VO 2 max were more pronounced in males than in females. CAEH also improved body composition and TC levels in sedentary obese adults.",2022,"The body mass index (BMI) (-1.2 kg/m 2 ,  p  < 0.01), body fat percentage (-3.2%,  p  < 0.001), visceral fat area (-12.8 cm 2 ,  ","['2) Methods: Eighty-four sedentary obese adults', 'Sedentary Obese Chinese Adults', 'sedentary Chinese adults', 'sedentary obese adults', 'sedentary adults after seven weeks', 'sedentary adults with overweight and obesity']","['progressive aerobic exercise and HIIT interventions', 'combined progressive aerobic exercise and HIIT (CAEH', 'CAEH', 'aerobic exercise and high-intensity interval training (HIIT', 'CON', 'Combined Exercise Intervention']","['Fat Oxidation and Body Composition', 'FO_rest, MFO, and VO 2 max', 'fat oxidation and fat reduction', 'visceral fat area', 'maximal fat oxidation (MFO', 'fat oxidation', 'maximal oxygen intake (VO 2 max) ', 'fat oxidation and reduce fat', 'total cholesterol (TC) levels', 'body composition and TC levels', 'improvements in FO_rest and VO 2 max', 'Anthropometric, lipid profile, cardiorespiratory fitness, and fat oxidation outcomes', 'body fat percentage', 'body mass index (BMI']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",84.0,0.00911163,"The body mass index (BMI) (-1.2 kg/m 2 ,  p  < 0.01), body fat percentage (-3.2%,  p  < 0.001), visceral fat area (-12.8 cm 2 ,  ","[{'ForeName': 'Jingguo', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Exercise, Health and Technology Centre, Department of Physical Education, Shanghai Jiao Tong University, Shanghai 200240, China.'}, {'ForeName': 'Siman', 'Initials': 'S', 'LastName': 'Lei', 'Affiliation': 'Exercise, Health and Technology Centre, Department of Physical Education, Shanghai Jiao Tong University, Shanghai 200240, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': 'Exercise, Health and Technology Centre, Department of Physical Education, Shanghai Jiao Tong University, Shanghai 200240, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Exercise, Health and Technology Centre, Department of Physical Education, Shanghai Jiao Tong University, Shanghai 200240, China.'}, {'ForeName': 'Zunqiang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""Sixth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200030, China.""}, {'ForeName': 'Sulin', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Exercise, Health and Technology Centre, Department of Physical Education, Shanghai Jiao Tong University, Shanghai 200240, China.'}, {'ForeName': 'Xiuqiang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Exercise, Health and Technology Centre, Department of Physical Education, Shanghai Jiao Tong University, Shanghai 200240, China.'}]",Journal of clinical medicine,['10.3390/jcm11041086']
2337,35208792,Paraprobiotics in Non-Surgical Periodontal Therapy: Clinical and Microbiological Aspects in a 6-Month Follow-Up Domiciliary Protocol for Oral Hygiene.,"Periodontal disease represents a progressive destruction of tooth-supporting tissues. Recently, paraprobiotics are regarded as an adjunctive therapy to the non-surgical Scaling-and-Root-Planing (SRP). The aim of this study is to evaluate the efficacy of two new formulations of paraprobiotics, a toothpaste and a mouthwash, respectively, for the domiciliary hygiene. A total of 40 patients were randomly assigned to the following domiciliary treatments: Group 1 (SRP + Curasept Intensive Treatment 0.2% chlorhexidine) (control) and Group 2 (SRP + Biorepair Peribioma toothpaste + Biorepair Peribioma Mousse mouthwash) (trial). At baseline (T 0 ) and after 3 and 6 months (T 1 -T 2 ), periodontal clinical (Bleeding on Probing, Probing Pocket Depth, Clinical Attachment Loss, Bleeding Score, Sulcus Bleeding Index, Plaque Index, Approximal Plaque Index, Adherent Gingiva, Gingival Recession, and Pathological Sites) and microbiological parameters (Pathological Bacteria, Saprophytic Bacteria, Enlarged Red Complex, Red Complex, Orange Complex, and counts of  Aggregatibacter actinomycetemcomitans ,  Porphyromonas gingivalis ,  Tannerella forsythensys ,  Treponema denticola ,  Prevotella intermedia , and  Fusobacterium nucleatum ). The use of the experimental products resulted in a significant reduction of most of the clinical indices assessed, which occurred at a major degree with respect to the conventional chlorhexidine considered as control. Additionally, after 6 months of use, the abovementioned products significantly decreased the percentage of pathological bacteria and the counts of those bacteria constituting the ""Red Complex"", more related to the periodontal disease. Accordingly, the paraprobiotics-based products tested in this study seem to represent a valid support to SRP with a benefit on both clinical indices and on specific periodontopathogens.",2022,"Additionally, after 6 months of use, the abovementioned products significantly decreased the percentage of pathological bacteria and the counts of those bacteria constituting the ""Red Complex"", more related to the periodontal disease.","['Paraprobiotics in Non-Surgical Periodontal Therapy', '40 patients']","['domiciliary treatments: Group 1 (SRP + Curasept Intensive Treatment 0.2% chlorhexidine) (control) and Group 2 (SRP + Biorepair Peribioma toothpaste + Biorepair Peribioma Mousse mouthwash', 'conventional chlorhexidine']","['percentage of pathological bacteria', 'periodontal clinical (Bleeding on Probing, Probing Pocket Depth, Clinical Attachment Loss, Bleeding Score, Sulcus Bleeding Index, Plaque Index, Approximal Plaque Index, Adherent Gingiva, Gingival Recession, and Pathological Sites) and microbiological parameters (Pathological Bacteria, Saprophytic Bacteria, Enlarged Red Complex, Red Complex, Orange Complex, and counts of']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0338047', 'cui_str': 'Domiciliary'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0453555', 'cui_str': 'Mousse'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0440277', 'cui_str': 'Orange - fruit'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",40.0,0.0531281,"Additionally, after 6 months of use, the abovementioned products significantly decreased the percentage of pathological bacteria and the counts of those bacteria constituting the ""Red Complex"", more related to the periodontal disease.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Butera', 'Affiliation': 'Unit of Dental Hygiene, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pascadopoli', 'Affiliation': 'Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Maiorani', 'Affiliation': 'Unit of Dental Hygiene, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Milone', 'Affiliation': 'Unit of Dental Hygiene, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Alovisi', 'Affiliation': 'Department of Surgical Sciences, Dental School, University of Turin, 0121 Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Scribante', 'Affiliation': 'Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, 27100 Pavia, Italy.'}]",Microorganisms,['10.3390/microorganisms10020337']
2338,35208739,Probiotics Reduce Vaginal Candidiasis in Pregnant Women via Modulating Abundance of  Candida  and  Lactobacillus  in Vaginal and Cervicovaginal Regions.,"We previously reported on the effects of a lactobacilli probiotic (SynForU-HerCare; two capsules/day of 9.5 log CFU/capsule) in improving symptoms of vaginal irritation, discharge and burning in pregnant women with vaginal candidiasis upon administration for 8 weeks, accompanied by improved emotional and social quality of life parameters. Thus, the present study aimed to analyse vaginal microbiota and inflammatory changes in hope to better understand the improved clinical symptoms as observed previously. Patients in the probiotic group showed a decreased abundance of  Candida glabrata  after 8 weeks ( p  = 0.009) in the lower vaginal region, while patients in the placebo group did not show any changes over time. In the higher vaginal and cervicovaginal regions, patients in the placebo group showed a decreased abundance of  Candida albicans  only within 4 weeks ( p  < 0.05) but no changes in abundance of  C. glabrata  over time, while patients in the probiotic group showed a continuous decreased abundance of  C. albicans  and  C. glabrata  over 8 weeks ( p  < 0.05). Patients in the placebo group also had a decreased abundance of  Lactobacillus crispatus  over 4 weeks ( p  = 0.023) in the lower vaginal region and a decreased abundance of  L. jensenii  over 8 weeks in the cervicovaginal region ( p  = 0.001). Meanwhile, patients in the probiotic group had an increased abundance of  L. crispatus  in the lower vaginal region after 8 weeks ( p  = 0.012) and  Lactobacillus jensenii  over 4 weeks in the cervicovaginal region ( p  < 0.001). Inflammation may have occurred in both low and high vaginal regions, predominantly observed by the increased concentration of pro-inflammatory cytokine TNF-alpha in patients from the placebo group ( p  < 0.05), while the administration of probiotics has shortened the period of inflammation as observed from the reduced need for anti-inflammatory cytokine IL-4 and IL-10 over time ( p  < 0.05). Taken together, our present new data further support previous findings that probiotic SynForU-HerCare had a beneficial effect against vaginal candidiasis in pregnant women via modulation of the vaginal microbiota and microenvironment.",2022,Patients in the placebo group also had a decreased abundance of  Lactobacillus crispatus  over 4 weeks ( p  = 0.023) in the lower vaginal region and a decreased abundance of  L. jensenii  over 8 weeks in the cervicovaginal region ( p  = 0.001).,"['pregnant women via modulation of the vaginal microbiota and microenvironment', 'pregnant women with vaginal candidiasis', 'Pregnant Women via Modulating Abundance of  Candida  and  Lactobacillus  in Vaginal and Cervicovaginal Regions']","['placebo', 'HerCare', 'probiotic SynForU', 'Probiotics', 'lactobacilli probiotic (SynForU-HerCare; two capsules/day of 9.5 log CFU/capsule']","['abundance of  Candida glabrata', 'abundance of  C. albicans  and  C. glabrata', 'abundance of  Lactobacillus crispatus', 'Vaginal Candidiasis', 'abundance of  C. glabrata', 'abundance of  L. jensenii', 'concentration of pro-inflammatory cytokine TNF-alpha', 'symptoms of vaginal irritation, discharge and burning', 'beneficial effect against vaginal candidiasis', 'abundance of  Candida albicans', 'abundance of  L. crispatus', 'emotional and social quality of life parameters']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0006852', 'cui_str': 'Candidiasis of vagina'}, {'cui': 'C0006836', 'cui_str': 'Candida'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}]","[{'cui': 'C0319899', 'cui_str': 'Candida glabrata'}, {'cui': 'C0317614', 'cui_str': 'Lactobacillus crispatus'}, {'cui': 'C0006852', 'cui_str': 'Candidiasis of vagina'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0558368', 'cui_str': 'Vaginal irritation'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0006837', 'cui_str': 'Candida albicans'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.159241,Patients in the placebo group also had a decreased abundance of  Lactobacillus crispatus  over 4 weeks ( p  = 0.023) in the lower vaginal region and a decreased abundance of  L. jensenii  over 8 weeks in the cervicovaginal region ( p  = 0.001).,"[{'ForeName': 'Xin Yee', 'Initials': 'XY', 'LastName': 'Ang', 'Affiliation': 'School of Industrial Technology, Universiti Sains Malaysia, Penang 11800, Malaysia.'}, {'ForeName': 'Uma Mageswary', 'Initials': 'UM', 'LastName': 'Mageswaran', 'Affiliation': 'School of Industrial Technology, Universiti Sains Malaysia, Penang 11800, Malaysia.'}, {'ForeName': 'Yi Li Fiona', 'Initials': 'YLF', 'LastName': 'Chung', 'Affiliation': 'School of Industrial Technology, Universiti Sains Malaysia, Penang 11800, Malaysia.'}, {'ForeName': 'Boon Kiat', 'Initials': 'BK', 'LastName': 'Lee', 'Affiliation': 'School of Industrial Technology, Universiti Sains Malaysia, Penang 11800, Malaysia.'}, {'ForeName': 'Siti Nur Afiqah', 'Initials': 'SNA', 'LastName': 'Azhar', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kelantan 16150, Malaysia.'}, {'ForeName': 'Nurhanis Syazni', 'Initials': 'NS', 'LastName': 'Roslan', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kelantan 16150, Malaysia.'}, {'ForeName': 'Ili Farhana Binti', 'Initials': 'IFB', 'LastName': 'Saufian', 'Affiliation': 'Kota Bharu Health Clinic, Ministry of Health Malaysia, Kelantan 15200, Malaysia.'}, {'ForeName': 'Nor Sheila', 'Initials': 'NS', 'LastName': 'Mustaffa', 'Affiliation': 'Kubang Kerian Health Clinic, Ministry of Health Malaysia, Kelantan 16150, Malaysia.'}, {'ForeName': 'Ermadina Mohamad', 'Initials': 'EM', 'LastName': 'Kalam', 'Affiliation': 'Pengkalan Chepa Health Clinic, Ministry of Health Malaysia, Kelantan 16100, Malaysia.'}, {'ForeName': 'Aini Farhah', 'Initials': 'AF', 'LastName': 'Ibrahim', 'Affiliation': 'Wakaf Che Yeh Health Clinic, Ministry of Health Malaysia, Kelantan 15100, Malaysia.'}, {'ForeName': 'Normala', 'Initials': 'N', 'LastName': 'Abdul Wahid', 'Affiliation': 'Sejahtera Centre, Universiti Sains Malaysia, Penang 11800, Malaysia.'}, {'ForeName': 'Zakuan Zainy', 'Initials': 'ZZ', 'LastName': 'Deris', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kelantan 16150, Malaysia.'}, {'ForeName': 'Chern-Ein', 'Initials': 'CE', 'LastName': 'Oon', 'Affiliation': 'Institute for Research in Molecular Medicine (INFORMM), Universiti Sains Malaysia, Penang 11800, Malaysia.'}, {'ForeName': 'Wan Fadhlina Wan', 'Initials': 'WFW', 'LastName': 'Adnan', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kelantan 16150, Malaysia.'}, {'ForeName': 'Salina', 'Initials': 'S', 'LastName': 'Sany', 'Affiliation': 'Advanced Medical and Dental Institute, Universiti Sains Malaysia, Penang 13200, Malaysia.'}, {'ForeName': 'Min-Tze', 'Initials': 'MT', 'LastName': 'Liong', 'Affiliation': 'School of Industrial Technology, Universiti Sains Malaysia, Penang 11800, Malaysia.'}]",Microorganisms,['10.3390/microorganisms10020285']
2339,35208665,Echinacea  as a Potential Force against Coronavirus Infections? A Mini-Review of Randomized Controlled Trials in Adults and Children.,"Echinacea purpurea  has been shown to broadly inhibit coronaviruses and SARS-CoV-2 in vitro. This review discusses the available clinical evidence from randomized, blinded and controlled human studies. Two RCTs capturing incidence of viral respiratory tract infections during  Echinacea  preventative treatment were identified including coronavirus infections. Incidence and/or viral loads were measured by RT-PCR and symptom severity was recorded. In a first study, Jawad et al. collected nasopharyngeal swabs from adults (N = 755) over 4 months of continuous prevention. Overall, 24 and 47 enveloped virus infections occurred, including 21 and 33 coronavirus detections (229E; HKU1; OC43) with Echinaforce ®  extract (2400 mg daily) and placebo, respectively ( p  = 0.0114). In a separate study, Ogal et al. administered the same extract (1200 mg) or control for 4 months to children (4-12 years) (N = 203).  Echinacea  reduced the incidence of enveloped virus infections from 47 to 29 ( p  = 0.0038) whereas 11 and 13 coronavirus detections (229E, OC43, NL63) were counted ( p  > 0.05). Respiratory symptoms during coronavirus infections were significantly lower with area-under-curve AUC = 75.8 (+/-50.24) versus 27.1 (+/-21.27) score points ( p  = 0.0036). Importantly, viral loads in nasal secretions were significantly reduced by 98.5% in the  Echinacea  group, with Ct-values 31.1 [95% CI 26.3; 35.9] versus 25.0 [95% CI 20.5; 29.5] in the control group ( p  = 0.0479). Results from clinical studies confirm the antiviral activity found for  Echinacea  in vitro, embracing enveloped respiratory pathogens and therefore coronaviruses as well. Substantiating results from a new, completed study seem to extrapolate these effects to the prevention of SARS-CoV-2 infections. As hypothesized, the established broad antiviral activity of  Echinacea  extract appears to be inclusive for SARS-CoV-2.",2022,"Echinacea  reduced the incidence of enveloped virus infections from 47 to 29 ( p  = 0.0038) whereas 11 and 13 coronavirus detections (229E, OC43, NL63) were counted ( p  > 0.05).",['Adults and Children'],['placebo'],"['Incidence and/or viral loads', 'viral loads in nasal secretions', 'viral respiratory tract infections', 'incidence of enveloped virus infections', 'Respiratory symptoms', 'RT-PCR and symptom severity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0877203', 'cui_str': 'Respiratory tract infection viral'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",,0.106357,"Echinacea  reduced the incidence of enveloped virus infections from 47 to 29 ( p  = 0.0038) whereas 11 and 13 coronavirus detections (229E, OC43, NL63) were counted ( p  > 0.05).","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Nicolussi', 'Affiliation': 'iC-Cure Scientific, 9404 Rorschacherberg, Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ardjomand-Woelkart', 'Affiliation': 'Department of Pharmacognosy, Institute of Pharmaceutical Sciences, University of Graz, 8010 Graz, Austria.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Stange', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität and Humboldt-Universität zu Berlin, 10117 Berlin, Germany.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gancitano', 'Affiliation': '1st ""Tuscania"" Paratrooper Regiment Carabinieri, Italian Ministry of Defence, 57127 Livorno, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'd.s.h. Statistical Services GmbH, 85296 Rohrbach, Germany.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Ogal', 'Affiliation': 'Pediatric Clinic, 6440 Brunnen, Switzerland.'}]",Microorganisms,['10.3390/microorganisms10020211']
2340,35208601,A Comparison in Patient Comfort Using Conventional Syringe and Needleless Jet Anesthesia Technique in Periodontal Surgery-A Split-Mouth Randomized Clinical Trial.,"Background and Objectives:  Periodontal surgery requires local anesthetic coverage to alleviate patient discomfort. Needles and injections can engender feelings of fear and anxiety in individuals. This study aimed to assess the level of comfort and anxiety in patients during the administration of local anesthesia using needleless jet anesthesia (JA) when compared to a conventional syringe (CS) in periodontal surgery.  Method and Materials:  60 sites were designated for injection in a split-mouth design in 30 subjects who required periodontal surgery. Local anesthesia was administered in two appointments scheduled one week apart using either a JA system or a CS. The Visual Analogue Scale (VAS), Verbal Rating Scale (VRS), and Beck's anxiety inventory were used to report the pain and anxiety levels while injecting local anesthesia. Statistical analysis of the results was performed using the Shapiro-Wilks test and Paired t-test.  Results:  Patients reported greater comfort with JA. The VAS and VRS values were statistically significant-( p  = 0.003) and ( p  = 0.001), respectively. Patients showed fear and were nervous about receiving a local anesthetic using a CS. A few subjects experienced lingering pain with the CS, whereas greater comfort and no lingering soreness were reported post-operatively at the site of JA administration.  Conclusions:  This study provides the first comprehensive assessment of using JA for periodontal surgical procedures. Lower pain scores were consistently observed with the use of jet injectors. Patients were at ease and reported lesser anxiety and greater comfort with jet injectors, making it ideally suited for providing local anesthesia in periodontal surgery.",2022,"Patients were at ease and reported lesser anxiety and greater comfort with jet injectors, making it ideally suited for providing local anesthesia in periodontal surgery.","['30 subjects who required periodontal surgery', 'patients during the administration of', 'individuals']","['Conventional Syringe and Needleless Jet Anesthesia Technique', 'Local anesthesia', 'conventional syringe (CS', 'local anesthesia using needleless jet anesthesia (JA']","['Lower pain scores', 'VAS and VRS values', 'level of comfort and anxiety', 'greater comfort with JA', 'greater comfort and no lingering soreness', 'lingering pain', 'pain and anxiety levels', ""Visual Analogue Scale (VAS), Verbal Rating Scale (VRS), and Beck's anxiety inventory""]","[{'cui': 'C0398950', 'cui_str': 'Periodontal operation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}]",30.0,0.0584136,"Patients were at ease and reported lesser anxiety and greater comfort with jet injectors, making it ideally suited for providing local anesthesia in periodontal surgery.","[{'ForeName': 'Preethi', 'Initials': 'P', 'LastName': 'Shankar', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Chennai 600095, India.'}, {'ForeName': 'Burnice Nalina Kumari', 'Initials': 'BNK', 'LastName': 'Chellathurai', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Chennai 600095, India.'}, {'ForeName': 'S Ashok', 'Initials': 'SA', 'LastName': 'Kumar', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Chennai 600095, India.'}, {'ForeName': 'Jaideep', 'Initials': 'J', 'LastName': 'Mahendra', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Chennai 600095, India.'}, {'ForeName': 'Maryam H', 'Initials': 'MH', 'LastName': 'Mugri', 'Affiliation': 'Department of Maxillofacial Surgery and Diagnostic Sciences, College of Dentistry, Jazan University, Jazan 45412, Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Sayed', 'Affiliation': 'Department of Prosthetic Dental Sciences, College of Dentistry, Jazan University, Jazan 45412, Saudi Arabia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Almagbol', 'Affiliation': 'Department of Community and Periodontics, Faculty of Dentistry, King Khalid University, Abha 61421, Saudi Arabia.'}, {'ForeName': 'Mohammed Hussain Dafer', 'Initials': 'MHD', 'LastName': 'Al Wadei', 'Affiliation': 'Department of Restorative Dental Science, College of Dentistry, King Khalid University, Abha 61421, Saudi Arabia.'}, {'ForeName': 'Rajaram', 'Initials': 'R', 'LastName': 'Vijayalakshmi', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Chennai 600095, India.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Chennai 600095, India.'}, {'ForeName': 'A Thirumal', 'Initials': 'AT', 'LastName': 'Raj', 'Affiliation': 'Department of Oral Pathology and Microbiology, Sri Venkateswara Dental College and Hospital, Chennai 600130, India.'}, {'ForeName': 'Shankargouda', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Department of Maxillofacial Surgery and Diagnostic Sciences, Division of Oral Pathology, College of Dentistry, Jazan University, Jazan 45142, Saudi Arabia.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina58020278']
2341,35209934,"Effect of fecal microbiota transplantation on primary hypertension and the underlying mechanism of gut microbiome restoration: protocol of a randomized, blinded, placebo-controlled study.","BACKGROUND


Hypertension is currently the leading modifiable cause of global morbidity and mortality, leading to substantial health and financial burdens. Although multiple studies of management models and innovative therapeutic strategies for hypertension have been conducted, there are still gaps in the field, with a poor control rate reflecting a lack of novel, effective, clinically translated medication or intervention options. Recent animal and human studies repeatedly confirmed a link between the microbiota and hypertension. Of note is our previous study establishing a cause-and-effect relationship between the gut microbiota and blood pressure elevation. A hypothesis of gut microbiota intervention for treating hypertension is thus postulated, and fecal microbiota transplantation (FMT) from healthy donors was performed.
METHODS


A multicenter, randomized, placebo-controlled, blinded clinical trial will be performed in 120 grade 1 hypertensive patients for 3 months. All recruited patients will be randomly assigned in a 1:1 ratio to take oral FMT capsules or placebo capsules on day 1, day 7, and day 14 and will be followed up on day 30, day 60, and day 90. The primary outcome is the change in office systolic blood pressure from baseline to day 30. The main secondary outcomes are BP indicators, including changes in systolic and diastolic blood pressure from office and 24-h ambulatory blood pressure monitoring; assessments of ankle-branchial index and pulse wave velocity; profiling of fecal microbial composition and function; profiling of fecal and serum metabolome; changes in levels of blood glucose, blood lipids, and body mass index; and assessment of adverse events as a measure of safety.
DISCUSSION


Expanding upon our previous research on the role of the gut microbiota in the pathogenesis of hypertension, this study serves as a clinical translation advancement and explores the potential of fecal microbiota transplantation for treating hypertension. The underlying mechanisms, particularly the roles of specific microorganisms or their postbiotics in blood pressure amelioration, will also be investigated via multiple approaches, such as metagenomic sequencing and metabolomic profiling.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04406129 . Registered on May 28, 2020.",2022,"A hypothesis of gut microbiota intervention for treating hypertension is thus postulated, and fecal microbiota transplantation (FMT) from healthy donors was performed.
",['120 grade 1 hypertensive patients for 3 months'],"['gut microbiota intervention', 'oral FMT capsules or placebo', 'placebo', 'fecal microbiota transplantation']","['change in office systolic blood pressure', 'BP indicators, including changes in systolic and diastolic blood pressure from office and 24-h ambulatory blood pressure monitoring; assessments of ankle-branchial index and pulse wave velocity; profiling of fecal microbial composition and function; profiling of fecal and serum metabolome; changes in levels of blood glucose, blood lipids, and body mass index; and assessment of adverse events as a measure of safety']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.270739,"A hypothesis of gut microbiota intervention for treating hypertension is thus postulated, and fecal microbiota transplantation (FMT) from healthy donors was performed.
","[{'ForeName': 'Luyun', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Hypertension Center, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'Shanxi Bethune Hospital, Taiyuan, Shanxi, China.'}, {'ForeName': 'Youren', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The Second Affiliated Hospital of Shantou University, Shantou, Guangdong, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Medical Research & Biometrics Center, National Center for Cardiovascular Diseases, Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Zihong', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Fuwai Yunnan Cardiovascular Hospital, Kunming, Yunnan, China.'}, {'ForeName': 'Peili', 'Initials': 'P', 'LastName': 'Bu', 'Affiliation': 'Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""The People's Hospital of Ji Xian District, Tianjin, China.""}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Hypertension Center, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Bingpo', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Southern University of Science and Technology Hospital, Shenzhen, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Medical Research & Biometrics Center, National Center for Cardiovascular Diseases, Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Hypertension Center, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. caijun7879@126.com.'}]",Trials,['10.1186/s13063-022-06086-2']
2342,35209924,The impact of kidney function in patients on antithrombotic therapy: a post hoc subgroup analysis focusing on recurrent bleeding events from the AFIRE trial.,"BACKGROUND


The success of antithrombotic therapies is assessed based on thrombotic and bleeding events. Simultaneously assessing both kinds of events might be challenging, and recurrent bleeding events are often ignored. We tried to confirm the effects of kidney function on outcome events in patients undergoing antithrombotic therapy.
METHODS


As a post hoc subgroup analysis of the Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) trial, a randomized clinical trial with a median follow-up of 36 months, patients were divided into high and low estimated glomerular filtration rate (eGFR) groups with a cutoff value of 50 mL/min. The cumulative incidence of bleeding and crude incidence of recurrent bleeding per 100 patient-years were calculated. We used the Cox regression model with multiple failure time data for recurrent bleeding events.
RESULTS


Among 2092 patients, 1386 (66.3%) showed high eGFR. The cumulative bleeding events per 100 patients at 1 year were 5.4 and 6.2 in the high and low eGFR groups, respectively. The difference continued to increase over time. The hazard ratio for time to the first bleeding event in the high eGFR group was 0.875 (95% confidence interval 0.701-1.090, p = .234) and that for the first composite event was 0.723 (95% confidence interval 0.603-0.867, p < .000). The recurrent bleeding events per 100 person-years were 11.3 and 15.3 in the high and low eGFR groups, respectively, with a rate ratio of 0.738 (95% confidence interval 0.615-0.886, p = .001). During the observation period, the risk of bleeding changed with time. It peaked soon after the study enrollment in both groups. It decreased continuously in the high eGFR group but remained high in the low eGFR group.
CONCLUSIONS


We reaffirmed that kidney function affects bleeding events in patients on antithrombotic therapy, considering recurrent events. Patients should have detailed discussions with physicians regarding the possible bleeding events when continuing antithrombotic therapy, especially in patients with decreased kidney function.
TRIAL REGISTRATION


UMIN Clinical Trials Registry, UMIN000016612 . ClinicalTrials.gov, NCT02642419 . Registered on 21 October 2015.",2022,The hazard ratio for time to the first bleeding event in the high eGFR group was 0.875,"['patients on antithrombotic therapy', 'patients undergoing antithrombotic therapy', 'Patients with Stable Coronary Artery Disease (AFIRE) trial', '2092 patients, 1386 (66.3%) showed high eGFR', 'patients on antithrombotic therapy, considering recurrent events']",['Rivaroxaban'],"['hazard ratio for time to the first bleeding event', 'cumulative incidence of bleeding and crude incidence of recurrent bleeding', 'cumulative bleeding events', 'risk of bleeding', 'recurrent bleeding events', 'kidney function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",2092.0,0.099297,The hazard ratio for time to the first bleeding event in the high eGFR group was 0.875,"[{'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Matsui', 'Affiliation': 'Department of General Medicine and Primary Care, Kumamoto University Hospital, 1-1-1 Honjo, Chuo-ku, Kumamoto, Kumamoto, 860-8556, Japan. kmatsui@kumamoto-u.ac.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yasuda', 'Affiliation': 'Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kaikita', 'Affiliation': 'Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Kiyotake, Miyazaki, 889-1692, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Akao', 'Affiliation': 'Department of Cardiology, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Kyoto, 612-8555, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Ako', 'Affiliation': 'Department of Cardiovascular Medicine, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0373, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Matoba', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Fukuoka, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, 2-22-36, Ohashi, Meguro-ku, Tokyo, 153-8515, Japan.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Miyauchi', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo Tokyo Koto Geriatric Medical Center, 3-3-20 Shinsuna, Koto-ku, Tokyo, 136-0075, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Cardiovascular Center, Yokohama City University Medical Center, 4-57, Urafune-cho, Minami-ku, Yokohama, Kanagawa, 232-0024, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Hirayama', 'Affiliation': 'Department of Cardiology Osaka Police Hospital, 10-31 Kitayama-cho, Tennouji-ku, Osaka City, Osaka, 543-0035, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'Kumamoto University, 2-39-1 Kurokami, Chuo-ku, Kumamoto, 860-8555, Japan.'}]",BMC medicine,['10.1186/s12916-022-02268-6']
2343,35209911,Effect of aerobic exercise intensity on health-related quality of life in severe obesity: a randomized controlled trial.,"BACKGROUND


Aerobic exercise is an important part of obesity treatment and may improve health-related quality of life (HRQOL). The objective of this study was to compare the effect of two different exercise programs on health-related quality of life in patients with severe obesity.
METHODS


This was a single-center, open-label, randomized, parallel-group study comparing the effects of a 24-week moderate-intensity continuous training (MICT) program and a combined high-intensity interval training program with MICT (HIIT/MICT). The primary objective (specified secondary outcome) was to assess HRQOL by using the general health dimension of the Short Form Health Survey (SF-36). The secondary objectives were to assess other dimensional SF-36 scores, the impact of weight on the physical and psychosocial aspects of quality of life (IWQOL-Lite), and the burden of obesity-specific weight symptoms (WRSM).
RESULTS


73 patients were enrolled and reported patient reported outcome measures, with 71 patients (55% females) allocated to either MICT (n = 34) or HIIT/MICT (n = 37). In the intention-to-treat analysis, general health scores increased between baseline and 24-week follow-up in both the HIIT/MICT group and the MICT group, with a mean change of 13 (95% CI 6-21) points and 11 (95% CI 5-17) points, respectively, with no difference between the groups. The effect sizes of these changes were moderate. The vitality and social functioning scores of SF-36, and the physical function and self-esteem scores of IWQOL-Lite increased moderately in both groups, with no difference between groups. The tiredness, back pain, and physical stamina scores based on WRSM showed moderate to strong changes in both the groups.
CONCLUSIONS


Patients who had completed a combined HIIT/MICT program did not experience larger improvements in general health compared with those completing a clean 24-week MICT program. Exercise may confer general health benefits independent of intensity.
TRIALS REGISTRATION


Regional Committees for Medical and Health Research Ethics south east, Norway, October 23, 2013 (identifier: 2013/1849) and ClinicalTrials.gov December 8, 2014 (identifier: NCT02311738).",2022,"In the intention-to-treat analysis, general health scores increased between baseline and 24-week follow-up in both the HIIT/MICT group and the MICT group, with a mean change of 13 (95% CI 6-21) points and 11 (95% CI 5-17) points, respectively, with no difference between the groups.","['patients with severe obesity', 'severe obesity', '73 patients were enrolled and reported patient reported outcome measures, with 71 patients (55% females) allocated to either', 'south east, Norway, October 23, 2013']","['Aerobic exercise', 'exercise programs', '24-week moderate-intensity continuous training (MICT) program and a combined high-intensity interval training program with MICT (HIIT/MICT', 'aerobic exercise intensity', 'HIIT/MICT', 'MICT']","['health-related quality of life (HRQOL', 'dimensional SF-36 scores, the impact of weight on the physical and psychosocial aspects of quality of life (IWQOL-Lite), and the burden of obesity-specific weight symptoms (WRSM', 'general health scores', 'health-related quality of life', 'vitality and social functioning scores of SF-36, and the physical function and self-esteem scores of IWQOL-Lite', 'general health', 'tiredness, back pain, and physical stamina scores', 'HRQOL by using the general health dimension of the Short Form Health Survey (SF-36']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0243156', 'cui_str': 'psychosocial aspects'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0449816', 'cui_str': 'Specific weight'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0031808', 'cui_str': 'Endurance, Physical'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",73.0,0.0912189,"In the intention-to-treat analysis, general health scores increased between baseline and 24-week follow-up in both the HIIT/MICT group and the MICT group, with a mean change of 13 (95% CI 6-21) points and 11 (95% CI 5-17) points, respectively, with no difference between the groups.","[{'ForeName': 'Jarle', 'Initials': 'J', 'LastName': 'Berge', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Box 2168, 3103, Tønsberg, Norway. Jarle.berge@siv.no.'}, {'ForeName': 'Jøran', 'Initials': 'J', 'LastName': 'Hjelmesæth', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Box 2168, 3103, Tønsberg, Norway.'}, {'ForeName': 'Ronette L', 'Initials': 'RL', 'LastName': 'Kolotkin', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Box 2168, 3103, Tønsberg, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Støren', 'Affiliation': 'Nature, Health and Environment, University of South-Eastern Norway, Bø, Norway.'}, {'ForeName': 'Solfrid', 'Initials': 'S', 'LastName': 'Bratland-Sanda', 'Affiliation': 'Department of Sport, Physical Education and Outdoor Life Studies, University of South-Eastern Norway, Bø, Norway.'}, {'ForeName': 'Jens Kristoffer', 'Initials': 'JK', 'LastName': 'Hertel', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Box 2168, 3103, Tønsberg, Norway.'}, {'ForeName': 'Espen', 'Initials': 'E', 'LastName': 'Gjevestad', 'Affiliation': 'Clinic of Medicine and Rehabilitation, Vestfold Hospital Trust, Stavern, Norway.'}, {'ForeName': 'Milada Cvancarova', 'Initials': 'MC', 'LastName': 'Småstuen', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Box 2168, 3103, Tønsberg, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Helgerud', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Science, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Tomm', 'Initials': 'T', 'LastName': 'Bernklev', 'Affiliation': 'Faculty of Medicine, Institute for Clinical Medicine, University of Oslo, Oslo, Norway.'}]",Health and quality of life outcomes,['10.1186/s12955-022-01940-y']
2344,35209903,Making the most of audit and feedback to improve diabetes care: a qualitative study of the perspectives of Australian Diabetes Centres.,"BACKGROUND


Diabetes has high burden on the health system and the individual, and many people living with diabetes struggle to optimally manage their condition. In Australia, people living with diabetes attend a mixture of primary, secondary and tertiary care centres. Many of these Diabetes Centres participate in the Australian National Diabetes Audit (ANDA), a quality improvement (QI) activity that collects clinical information (audit) and feeds back collated information to participating sites (feedback). Despite receiving this feedback, many process and care outcomes for Diabetes Centres continue to show room for improvement. The purpose of this qualitative study was to inform improvement of the ANDA feedback, identify the needs of those receiving feedback and elicit the barriers to and enablers of optimal feedback use.
METHODS


Semi-structured interviews were conducted with representatives of Australian Diabetes Centres, underpinned by the Consolidated Framework for Implementation Research (CFIR). De-identified transcripts were analysed thematically, underpinned by the domains and constructs of the CFIR.
RESULTS


Representatives from 14 Diabetes centres participated in this study, including a diverse range of staff typical of the Diabetes Centres who take part in ANDA. In general, participants wanted a shorter report with a more engaging, simplified data visualisation style. Identified barriers to use of feedback were time or resource constraints, as well as access to knowledge about how to use the data provided to inform the development of QI activities. Enablers included leadership engagement, peer mentoring and support, and external policy and incentives. Potential cointerventions to support use include exemplars from clinical change champions and peer leaders, and educational resources to help facilitate change.
CONCLUSIONS


This qualitative study supported our contention that the format of ANDA feedback presentation can be improved. Healthcare professionals suggested actionable changes to current feedback to optimise engagement and potential implementation of QI activities. These results will inform redesign of the ANDA feedback to consider the needs and preferences of end users and to provide feedback and other supportive cointerventions to improve care, and so health outcomes for people with diabetes. A subsequent cluster randomised trial will enable us to evaluate the impact of these changes.",2022,"METHODS


Semi-structured interviews were conducted with representatives of Australian Diabetes Centres, underpinned by the Consolidated Framework for Implementation Research (CFIR).","['people living with diabetes attend a mixture of primary, secondary and tertiary care centres', 'people with diabetes', 'Semi-structured interviews were conducted with representatives of Australian Diabetes Centres, underpinned by the Consolidated Framework for Implementation Research (CFIR', 'Australian Diabetes Centres', '14 Diabetes centres participated in this study, including a diverse range of staff typical of the Diabetes Centres who take part in ANDA']",[],"['leadership engagement, peer mentoring and support, and external policy and incentives']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}]",[],"[{'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]",,0.073827,"METHODS


Semi-structured interviews were conducted with representatives of Australian Diabetes Centres, underpinned by the Consolidated Framework for Implementation Research (CFIR).","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Quigley', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Zoungas', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Zimbudzi', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Wischer', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Sofianos', 'Initials': 'S', 'LastName': 'Andrikopoulos', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Green', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia. sally.green@monash.edu.'}]",BMC health services research,['10.1186/s12913-022-07652-9']
2345,35209877,Evaluating willingness for surgery using the SMART Choice (Knee) patient prognostic tool for total knee arthroplasty: study protocol for a pragmatic randomised controlled trial.,"BACKGROUND


Approximately 1 in 5 patients feel unsatisfied after total knee arthroplasty (TKA). Prognostic tools may aid in the patient selection process and reduce the proportion of patients who experience unsatisfactory surgery. This study uses the prognostic tool SMART Choice (Patient Prognostic Tool for Total Knee Arthroplasty) to predict patient improvement after TKA. The tool aims to be used by the patient without clinician input and does not require clinical data such as X-ray findings or blood results. The objective of this study is to evaluate the SMART Choice tool on patient decision making, particularly willingness for surgery. We hypothesise that the use of the SMART Choice tool will influence willingness to undergo surgery, especially when used earlier in the patient TKA journey.
METHODS


This is a multicentred, pragmatic, randomised controlled trial conducted in Melbourne, Australia. Participants will be recruited from the St. Vincent's Hospital, Melbourne (SVHM) Orthopaedic Clinic, and the client base of HCF, Australia (private health insurance company). Patients over 45 years of age who have been diagnosed with knee osteoarthritis and considering TKA are eligible for participation. Participants will be randomised to either use the SMART Choice tool or treatment as usual. The SMART Choice tool provides users with a prediction for improvement or deterioration / no change after surgery based on utility score change calculated from the Veterans-RAND 12 (VR-12) survey. The primary outcome of the study is patient willingness for TKA surgery. The secondary outcomes include evaluating the optimal timing for tool use and using decision quality questionnaires to understand the patient experience when using the tool. Participants will be followed up for 6 months from the time of recruitment.
DISCUSSION


The SMART Choice tool has the potential to improve patient decision making for TKA. Although many prognostic tools have been developed for other areas of surgery, most are confined within academic bodies of work. This study will be one of the first to evaluate the impact of a prognostic tool on patient decision making using a prospective clinical trial, an important step in transitioning the tool for use in clinical practice.
TRIAL REGISTRATION


Australia and New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12622000072718 . Prospectively registered - 21 January 2022.",2022,This study uses the prognostic tool SMART Choice (Patient Prognostic Tool for Total Knee Arthroplasty) to predict patient improvement after TKA.,"['total knee arthroplasty', 'Prospectively registered - 21 January 2022', '5 patients feel unsatisfied after total knee arthroplasty (TKA', 'Total Knee Arthroplasty', 'Patients over 45\u2009years of age who have been diagnosed with knee osteoarthritis and considering TKA are eligible for participation', ""Participants will be recruited from the St. Vincent's Hospital, Melbourne (SVHM""]",['ANZCTR'],"['patient willingness for TKA surgery', 'optimal timing for tool use and using decision quality questionnaires to understand the patient experience']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",,0.226139,This study uses the prognostic tool SMART Choice (Patient Prognostic Tool for Total Knee Arthroplasty) to predict patient improvement after TKA.,"[{'ForeName': 'Yuxuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Surgery, The University of Melbourne, Melbourne, Australia. Yzho527@aucklanduni.ac.nz.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Weeden', 'Affiliation': 'Department of Surgery, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Patten', 'Affiliation': 'Department of Surgery, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Dowsey', 'Affiliation': 'Department of Surgery, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Bunzli', 'Affiliation': 'Department of Surgery, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Choong', 'Affiliation': 'Department of Surgery, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Schilling', 'Affiliation': 'Department of Surgery, The University of Melbourne, Melbourne, Australia.'}]",BMC musculoskeletal disorders,['10.1186/s12891-022-05123-0']
2346,35209851,"Effects of a new respiratory muscle training device in community-dwelling elderly men: an open-label, randomized, non-inferiority trial.","BACKGROUND


Respiratory muscle training (RMT) has various clinical benefits in older adults; however, the low adherence to training remains a challenging issue. The present study aimed to confirm the efficacy of a new device that combines inspiratory muscle training and a positive expiratory pressure (IMT/PEP) compared to that of a Threshold IMT device (Philips Respironics Inc), and to determine whether home-based training differed from rehabilitation center training.
METHODS


This four-arm, multicenter, parallel, non-inferiority trial randomized 80 active community-dwelling older men (mean age = 72.93 ± 5.02 years) to center-based groups (new IMT/PEP device or Threshold IMT device; 16 supervised sessions) or home-based groups (new IMT/PEP device or Threshold IMT device; 2 supervised sessions and individual sessions). Participants in all groups performed RMT twice a day for 8 weeks. Assessments were performed at baseline and post-training. The primary outcomes were maximum inspiratory pressure and maximal expiratory pressure. The secondary outcomes included forced vital capacity and forced expiratory volume in the first second, peak cough flow, diaphragm thickness, VO 2  peak, the International Physical Activity Questionnaire score, electromyographic activities of the sternocleidomastoid muscle, and skeletal muscle mass and phase angle as measured by bioimpedance analysis. In addition, rates of adherence to each protocol were also compared.
RESULTS


Among all groups, the maximal inspiratory pressure was improved post-training, while the maximal expiratory pressure showed improvement only in the IMT/PEP groups. The overall non-inferiority of the IMT/PEP device was thus validated. A statistically significant improvement in diaphragm thickness was found. However, no consistent improvement was shown in other secondary outcomes. No significant difference in training adherence rate between protocols was observed (mean adherence rate of 91-99%).
CONCLUSION


Compared to the Threshold IMT, the new IMT/PEP device did not result in a significant difference in maximal inspiratory pressure but did improve maximal expiratory pressure in older men. The IMT/PEP device's improved usability, which is associated with exercise adherence, provided distinct advantages in this cohort. If proper education is first provided, home-based RMT alone may provide sufficient effects in older individuals.
TRIAL REGISTRATION


This trial was registered in the database cris.nih.go.kr (registration number KCT0003901 ) on 10/05/2019.",2022,"Among all groups, the maximal inspiratory pressure was improved post-training, while the maximal expiratory pressure showed improvement only in the IMT/PEP groups.","['community-dwelling elderly men', '80 active community-dwelling older men (mean age\u2009=\u200972.93\u2009±\u20095.02\u2009years) to center-based groups (new', 'older individuals', 'older men', 'older adults']","['new device that combines inspiratory muscle training and a positive expiratory pressure (IMT/PEP', 'Respiratory muscle training (RMT', 'IMT/PEP device or Threshold IMT device; 16 supervised sessions) or home-based groups (new IMT/PEP device or Threshold IMT device; 2 supervised sessions and individual sessions', 'new respiratory muscle training device']","['maximal expiratory pressure', 'forced vital capacity and forced expiratory volume in the first second, peak cough flow, diaphragm thickness, VO 2  peak, the International Physical Activity Questionnaire score, electromyographic activities of the sternocleidomastoid muscle, and skeletal muscle mass and phase angle as measured by bioimpedance analysis', 'maximum inspiratory pressure and maximal expiratory pressure', 'rates of adherence', 'training adherence rate', 'maximal inspiratory pressure', 'diaphragm thickness']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4082175', 'cui_str': 'Maximum Expiratory Pressure'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}]",80.0,0.083697,"Among all groups, the maximal inspiratory pressure was improved post-training, while the maximal expiratory pressure showed improvement only in the IMT/PEP groups.","[{'ForeName': 'Sang Hun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Myung-Jun', 'Initials': 'MJ', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, Biomedical Research Institute, Pusan National University Hospital and Pusan National University School of Medicine, Busan, Republic of Korea.'}, {'ForeName': 'Jang Mi', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Busan Center for infectious Disease Control and Prevention, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Sungchul', 'Initials': 'S', 'LastName': 'Huh', 'Affiliation': 'Department of Rehabilitation Medicine, Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.'}, {'ForeName': 'Yong Beom', 'Initials': 'YB', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, Biomedical Research Institute, Pusan National University Hospital and Pusan National University School of Medicine, Busan, Republic of Korea. yi0314@gmail.com.'}]",BMC geriatrics,['10.1186/s12877-022-02828-8']
2347,35209847,"The effects of fentanyl, oxycodone, and butorphanol on gastrointestinal function in patients undergoing laparoscopic hysterectomy: a prospective, double-blind, randomized controlled trial.","BACKGROUND


Perioperative opioid use is associated with postoperative bowel dysfunction, which causes longer hospital stay and higher healthcare costs. This study aimed to investigate the effect of the equivalent doses of fentanyl, oxycodone, and butorphanol on bowel function in patients undergoing laparoscopic hysterectomy.
METHODS


In this randomized controlled trial, 135 patients undergoing laparoscopic hysterectomy received postoperative intravenous patient-controlled analgesia (IV-PCA) with fentanyl 8.3 μg/kg, butorphanol 0.16 mg/kg, and oxycodone 0.5 mg/kg (1: 20: 60), respectively. The primary outcome measure was the recovery of bowel function. We also evaluated and recorded the following nine indicators: pain score, sedation level, leukocyte count, percentage of neutrophils, plasma potassium levels, time to first ambulation, postoperative side effects, patients' satisfaction, and postoperative hospital length of stay.
RESULTS


The mean time to flatus was significantly prolonged in Group B (45.2 ± 11.6 h) compared with Group F (33.1 ± 11.2 h, P < 0.001) and Group O (36.2 ± 10.9 h, P = 0.001). The incidence of somnolence and dizziness prove higher in Group B (P < 0.001). No statistical difference was observed in the mean time to tolerate oral diet, time to defecation, analgesic outcome, satisfaction score, time to first ambulation, and postoperative hospital length of stay.
CONCLUSIONS


Compared with fentanyl and oxycodone, butorphanol prolonged the recovery of bowel function with more severe somnolence and dizziness, suggesting that butorphanol is not well suitable for IV-PCA in patients undergoing laparoscopic hysterectomy.
TRIAL REGISTRATION


ClinicalTrials.gov- NCT04295109 . Date of registration: March, 2020.",2022,"No statistical difference was observed in the mean time to tolerate oral diet, time to defecation, analgesic outcome, satisfaction score, time to first ambulation, and postoperative hospital length of stay.
","['135 patients undergoing', 'patients undergoing laparoscopic hysterectomy']","['laparoscopic hysterectomy received postoperative intravenous patient-controlled analgesia (IV-PCA) with fentanyl 8.3\xa0μg/kg, butorphanol 0.16\xa0mg/kg, and oxycodone', 'fentanyl, oxycodone, and butorphanol', 'fentanyl and oxycodone, butorphanol', 'butorphanol']","['mean time to tolerate oral diet, time to defecation, analgesic outcome, satisfaction score, time to first ambulation, and postoperative hospital length of stay', 'mean time to flatus', 'severe somnolence and dizziness', ""pain score, sedation level, leukocyte count, percentage of neutrophils, plasma potassium levels, time to first ambulation, postoperative side effects, patients' satisfaction, and postoperative hospital length of stay"", 'recovery of bowel function', 'gastrointestinal function', 'incidence of somnolence and dizziness']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}]","[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C4517431', 'cui_str': '0.16'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C1272115', 'cui_str': 'Plasma potassium level'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",135.0,0.412696,"No statistical difference was observed in the mean time to tolerate oral diet, time to defecation, analgesic outcome, satisfaction score, time to first ambulation, and postoperative hospital length of stay.
","[{'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'Faculty of Anesthesiology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Shijiang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'School of Public Health, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Chuanbao', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Cunming', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. cunmingliu@njmu.edu.cn.'}]",BMC anesthesiology,['10.1186/s12871-022-01594-9']
2348,35210118,Immunogenicity and safety of an intradermal fractional third dose of ChAdOx1 nCoV-19/AZD1222 vaccine compared with those of a standard intramuscular third dose in volunteers who previously received two doses of CoronaVac: A randomized controlled trial.,"INTRODUCTION


The CoronaVac vaccine is widely used in Thailand to combat the coronavirus disease 2019 (COVID-19) pandemic. The limited immunogenicity of this vaccine is a concern, especially because of expanding delta variant outbreaks. A third boost may enhance antiviral immune responses.
METHODS


This non-inferiority randomized controlled trial evaluated the immunogenicity and safety of an intradermal (ID) fractional third dose of AZD1222 vaccine compared with those of a standard intramuscular (IM) third dose. Participants were enrolled from August 9, 2021 to August 13, 2021 at Chulabhorn Hospital, Bangkok, Thailand. The eligibility criteria were age 18 years or older and prior two-dose Coronavac vaccination completed at least 2 months previously. Participants were randomly assigned to one of three groups by block randomization: (i) standard dose by IM administration (IM), (ii) 20% of the standard dose ID (ID1), or (iii) 40% of the standard dose ID (ID2). The primary endpoint was the geometric mean ratio of anti-receptor binding domain antibody in the ID1/ID2 vs. the IM groups 14 days post-vaccination.
RESULTS


A total of 125 participants were randomized (IM, n = 41; ID1, n = 41; and ID2, n = 43). One participant was lost to follow-up by day 14 post-vaccination in the ID1 group. The geometric mean ratio (95% confidence interval) of anti-receptor binding domain antibody was 0.94 (0.80-1.09) in the ID1 group and 1.28 (0.95-1.74) in the ID2 group. Immunogenicity in both ID groups met the non-inferiority criteria. Local adverse events were more common in the ID groups than in the IM group but were mostly mild to moderate in severity.
CONCLUSION


An ID fractional third dose of AZD1222 was non-inferior to a standard IM third dose among individuals previously vaccinated with CoronaVac. Adverse events associated with the ID fractional third dose included mild to moderate local site reactions. This vaccination strategy may help conserve vaccine supply.",2022,"Local adverse events were more common in the ID groups than in the IM group but were mostly mild to moderate in severity.
","['volunteers who previously received two doses of CoronaVac', 'The eligibility criteria were age 18\xa0years or older and prior two-dose Coronavac vaccination completed at least 2\xa0months previously', '125 participants', 'Participants were enrolled from August 9, 2021 to August 13, 2021 at Chulabhorn Hospital, Bangkok, Thailand']","['ChAdOx1 nCoV-19/AZD1222 vaccine', 'AZD1222', 'intradermal (ID) fractional third dose of AZD1222 vaccine']","['geometric mean ratio of anti-receptor binding domain antibody', 'Immunogenicity and safety', 'Local adverse events', 'Immunogenicity', 'immunogenicity and safety', 'geometric mean ratio']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",125.0,0.346244,"Local adverse events were more common in the ID groups than in the IM group but were mostly mild to moderate in severity.
","[{'ForeName': 'Kriangkrai', 'Initials': 'K', 'LastName': 'Tawinprai', 'Affiliation': 'Department of Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Thailand. Electronic address: Kriangkrai.taw@cra.ac.th.'}, {'ForeName': 'Taweegrit', 'Initials': 'T', 'LastName': 'Siripongboonsitti', 'Affiliation': 'Department of Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Thailand.'}, {'ForeName': 'Thachanun', 'Initials': 'T', 'LastName': 'Porntharukchareon', 'Affiliation': 'Department of Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Thailand.'}, {'ForeName': 'Kasiruck', 'Initials': 'K', 'LastName': 'Wittayasak', 'Affiliation': ""Center of Learning and Research in Celebration of HRH Princess Chulabhorn's 60(th) Birthday Anniversary, Chulabhorn Royal Academy, Thailand.""}, {'ForeName': 'Nawarat', 'Initials': 'N', 'LastName': 'Thonwirak', 'Affiliation': ""Center of Learning and Research in Celebration of HRH Princess Chulabhorn's 60(th) Birthday Anniversary, Chulabhorn Royal Academy, Thailand.""}, {'ForeName': 'Kamonwan', 'Initials': 'K', 'LastName': 'Soonklang', 'Affiliation': ""Center of Learning and Research in Celebration of HRH Princess Chulabhorn's 60(th) Birthday Anniversary, Chulabhorn Royal Academy, Thailand.""}, {'ForeName': 'Gaidganok', 'Initials': 'G', 'LastName': 'Sornsamdang', 'Affiliation': 'Central Laboratory Center, Chulabhorn Hospital, Chulabhorn Royal Academy, Thailand.'}, {'ForeName': 'Chirayu', 'Initials': 'C', 'LastName': 'Auewarakul', 'Affiliation': ""Center of Learning and Research in Celebration of HRH Princess Chulabhorn's 60(th) Birthday Anniversary, Chulabhorn Royal Academy, Thailand; Princess Srisavangavadhana College of Medicine, Chulabhorn Royal Academy, Thailand.""}, {'ForeName': 'Nithi', 'Initials': 'N', 'LastName': 'Mahanonda', 'Affiliation': 'Department of Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Thailand.'}]",Vaccine,['10.1016/j.vaccine.2022.02.019']
2349,35202974,FOLFIRI plus ramucirumab versus paclitaxel plus ramucirumab as second-line therapy for patients with advanced or metastatic gastroesophageal adenocarcinoma with or without prior docetaxel - results from the phase II RAMIRIS Study of the German Gastric Cancer Study Group at AIO.,"BACKGROUND


Ramucirumab and paclitaxel is the standard second-line therapy in patients with metastatic gastroesophageal adenocarcinoma. We report the efficacy and safety analyses of FOLFIRI and ramucirumab versus paclitaxel and ramucirumab after the failure of a platinum- and fluoropyrimidine-containing chemotherapy.
METHODS


This multicenter, investigator initiated, phase II trial randomised patients with gastroesophageal adenocarcinoma to either FOLFIRI plus ramucirumab (RAM) (arm A) or paclitaxel plus RAM (arm B). The primary end-point was 6-month overall survival (OS) rate, with a proportion of ≥65% in arm A considered a positive signal for further investigation.
RESULTS


111 patients (65% of patients had prior docetaxel) were enrolled and 110 patients qualified for ITT population (arm A, 72; arm B, 38). The study did not meet the primary end-point for the comparison with historical control, as 6-month OS rate in the FOLFIRI plus RAM arm was 54% (95% CI 44-67). In between arm comparison, OS was similar (hazard ratio, HR 0.97 [95% CI 0.62-1.52]), while objective response rates (ORRs) and PFS were numerically better in arm A versus arm B (HR for PFS 0.73; ORR, 22% versus 11%). These differences were largely attributed to favourable efficacy results for arm A in docetaxel-pretreated patients (HR, 0.49; ORR, 25% versus 8%). In the safety population (n = 106), grade 3-5 adverse events were similar between arms (arm A, 75%; arm B, 68%).
CONCLUSION


The RAMIRIS trial demonstrated feasibility of FOLFIRI plus RAM. While the study was formally negative, it provided a signal to further investigate this combination for the group of patients with previous docetaxel therapy.
TRIAL REGISTRATION


clinicaltrials.gov identifier: NCT03081143.",2022,"In between arm comparison, OS was similar (hazard ratio, HR 0.97","['patients with advanced or metastatic gastroesophageal adenocarcinoma with or without prior docetaxel - results from the phase II RAMIRIS Study of the German Gastric Cancer Study Group at AIO', '111 patients (65% of patients had prior docetaxel) were enrolled and 110 patients qualified for ITT population (arm A, 72; arm B, 38', 'patients with metastatic gastroesophageal adenocarcinoma', 'patients with gastroesophageal adenocarcinoma to either', 'patients with previous docetaxel therapy']","['Ramucirumab and paclitaxel', 'FOLFIRI plus RAM', 'FOLFIRI plus ramucirumab versus paclitaxel plus ramucirumab', 'FOLFIRI plus ramucirumab (RAM) (arm A) or paclitaxel plus RAM', 'FOLFIRI and ramucirumab versus paclitaxel and ramucirumab', 'platinum- and fluoropyrimidine-containing chemotherapy']","['objective response rates (ORRs) and PFS', '6-month OS rate', '6-month overall survival (OS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721207', 'cui_str': 'Metastatic gastroesophageal adenocarcinoma'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",111.0,0.13288,"In between arm comparison, OS was similar (hazard ratio, HR 0.97","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Lorenzen', 'Affiliation': 'Klinikum Rechts der Isar, Technische Universität München, III. Medizinische Klinik und Poliklinik, München, Germany. Electronic address: sylvielorenzen@gmx.de.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thuss-Patience', 'Affiliation': 'Charité - Universitätsmedizin Berlin/Campus Virchow Klinikum (CVK), Med. Klinik M. S. Hämatologie, Onkologie und Tumorimmunologie (CC14), Berlin, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pauligk', 'Affiliation': 'Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, Frankfurt, Germany.'}, {'ForeName': 'Eray', 'Initials': 'E', 'LastName': 'Gökkurt', 'Affiliation': 'Hämatologisch-Onkologische Praxis Eppendorf (HOPE), Facharztzentrum Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ettrich', 'Affiliation': 'Universitätsklinikum Ulm, Klinik für Innere Medizin I, Ulm, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lordick', 'Affiliation': 'Department of Oncology, Gastroenterology, Hepatology, Pulmonology, and Infectious Diseases, University Cancer Center Leipzig (UCCL), Leipzig University Medical Center, Leipzig, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stahl', 'Affiliation': 'Evang. Kliniken Essen-Mitte, Klinik für Internistische Onkologie und Hämatologie, Essen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reichardt', 'Affiliation': 'HELIOS Klinikum Berlin Buch, Klinik für Interdisziplinäre Onkologie, Sarkomzentrum Berlin-Brandenburg, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sökler', 'Affiliation': 'Universitätsklinikum Tübingen, Medizinische Klinik II, Tübingen, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pink', 'Affiliation': 'Klinik und Poliklinik für Innere Medizin C, Hämatologie und Onkologie, Transplantationszentrum, Palliativmedizin, Universität Greifswald, Greifswald, Germany; Klinik für Hämatologie, Onkologie und Palliativmedizin, Sarkomzentrum Berlin-Brandenburg, HELIOS Klinikum Bad-Saarow, Bad Saarow, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Probst', 'Affiliation': 'Klinikum Bielefeld Mitte, Klinik für Hämatologie, Onkologie U. Palliativmedizin, Bielefeld, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hinke', 'Affiliation': 'CCRC Cancer Clinical Research Consulting, Düsseldorf, Germany.'}, {'ForeName': 'Thorsten O', 'Initials': 'TO', 'LastName': 'Goetze', 'Affiliation': 'Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, Frankfurt, Germany; Krankenhaus Nordwest, Frankfurt, Germany.'}, {'ForeName': 'Salah E', 'Initials': 'SE', 'LastName': 'Al-Batran', 'Affiliation': 'Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, Frankfurt, Germany; Krankenhaus Nordwest, Frankfurt, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.01.015']
2350,35202942,"A virtual, pilot randomized trial of a brief intervention to prevent suicide in an integrated healthcare setting.","OBJECTIVE


Patients who die by suicide are often seen in primary care settings in the weeks leading to their death. There has been little study of brief interventions to prevent suicide in these settings.
METHOD


We conducted a virtual, pilot, randomized controlled trial of a brief suicide prevention strategy called Veterans Affairs Brief Intervention and Contact Program (VA BIC) in patients who presented to a primary care mental health walk-in clinic for a new mental health intake appointment and were at risk for suicide. Our primary aim was to assess feasibility. We measured our ability to recruit 20 patients. We measured the proportion of enrolled patients who completed all study assessments. We assessed adherence among patients assigned to VA BIC.
RESULTS


Twenty patients were enrolled and 95% (N = 19) completed all study assessments. Among the 10 patients assigned to VA BIC, 90% (N = 9) of patients completed all required intervention visits, and 100% (N = 10) completed ≥70% of the required interventions visits.
CONCLUSION


It is feasible to conduct a virtual trial of VA BIC in an integrated care setting. Future research should clarify the role of VA BIC as a suicide prevention strategy in integrated care settings using an adequately powered design.
CLINICAL TRIAL REGISTRATION


NCT04054947.",2022,"Among the 10 patients assigned to VA BIC, 90% (N = 9) of patients completed all required intervention visits, and 100% (N = 10) completed ≥70% of the required interventions visits.
","['20 patients', 'Twenty patients were enrolled and 95% (N\xa0=\xa019) completed all study assessments', 'patients who presented to a primary care mental health walk-in clinic for a new mental health intake appointment and were at risk for suicide']",['suicide prevention strategy called Veterans Affairs Brief Intervention and Contact Program (VA BIC'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0338034', 'cui_str': 'Walk-in clinic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}]","[{'cui': 'C0204732', 'cui_str': 'Suicide prevention'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],20.0,0.0838075,"Among the 10 patients assigned to VA BIC, 90% (N = 9) of patients completed all required intervention visits, and 100% (N = 10) completed ≥70% of the required interventions visits.
","[{'ForeName': 'Natalie B', 'Initials': 'NB', 'LastName': 'Riblet', 'Affiliation': 'Veterans Affairs Medical Center, 215 North Main Street, White River Junction, VT 05009, United States of America; Department of Psychiatry and Dartmouth Institute, Geisel School of Medicine, Dartmouth College, 1 Rope Ferry Road, Hanover, NH 03755, United States of America. Electronic address: Natalie.Riblet@dartmouth.edu.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Kenneally', 'Affiliation': 'Veterans Affairs Medical Center, 215 North Main Street, White River Junction, VT 05009, United States of America.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stevens', 'Affiliation': 'Veterans Affairs Medical Center, 215 North Main Street, White River Junction, VT 05009, United States of America; Department of Psychiatry, Geisel School of Medicine, Dartmouth College, 1 Rope Ferry Road, Hanover, NH 03755, United States of America.'}, {'ForeName': 'Bradley V', 'Initials': 'BV', 'LastName': 'Watts', 'Affiliation': 'Veterans Affairs Medical Center, 215 North Main Street, White River Junction, VT 05009, United States of America; Department of Psychiatry, Geisel School of Medicine, Dartmouth College, 1 Rope Ferry Road, Hanover, NH 03755, United States of America; Veterans Rural Health Resource Center, White River Junction VA Medical Center, 215 North Main Street, White River Junction, VT 05009, United States of America.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Gui', 'Affiliation': 'Veterans Affairs Medical Center, 215 North Main Street, White River Junction, VT 05009, United States of America; Department of Biomedical Data Science, Dartmouth Institute, Community and Family Medicine, Geisel School of Medicine, Dartmouth College, 1 Rope Ferry Road, Hanover, NH 03755, United States of America.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Forehand', 'Affiliation': 'Veterans Affairs Medical Center, 215 North Main Street, White River Junction, VT 05009, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cornelius', 'Affiliation': 'Veterans Affairs Medical Center, 215 North Main Street, White River Junction, VT 05009, United States of America.'}, {'ForeName': 'Glenna S', 'Initials': 'GS', 'LastName': 'Rousseau', 'Affiliation': 'Veterans Affairs Medical Center, 215 North Main Street, White River Junction, VT 05009, United States of America; Department of Psychiatry, Geisel School of Medicine, Dartmouth College, 1 Rope Ferry Road, Hanover, NH 03755, United States of America.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Schwartz', 'Affiliation': 'Veterans Affairs Medical Center, 215 North Main Street, White River Junction, VT 05009, United States of America; Department of Psychiatry, Geisel School of Medicine, Dartmouth College, 1 Rope Ferry Road, Hanover, NH 03755, United States of America.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Shiner', 'Affiliation': 'Veterans Affairs Medical Center, 215 North Main Street, White River Junction, VT 05009, United States of America; Department of Psychiatry and Dartmouth Institute, Geisel School of Medicine, Dartmouth College, 1 Rope Ferry Road, Hanover, NH 03755, United States of America; National Center for PTSD, Mental Health Service, Veterans Affairs Medical Center, 215 North Main Street, White River Junction, VT 05009, United States of America.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2022.02.002']
2351,35204519,Impact of Macroscopic On-Site Evaluation (MOSE) on Accuracy of Endoscopic Ultrasound-Guided Fine-Needle Biopsy (EUS-FNB) of Pancreatic and Extrapancreatic Solid Lesions: A Prospective Study.,"This is a prospective and comparative study including 76 consecutive patients performing EUS-FNB for pancreatic and extrapancreatic solid lesions, randomized by alternate allocation to macroscopic on-site evaluation (MOSE) (40 patients) or to a conventional technique (40 patients), with three passes each. MOSE samples were differentiated into score 0: no visible material, score 1: only necrotic or haematic material, score 2: white core tissue ≤ 2 mm, or score 3: white core tissue > 2 mm. The conventional technique consisted in pushing all the needle content into a test tube for evaluation by the pathologist. In both groups, a 22-25 Gauge Franseen-tip needle (Acquire, Boston Scientific Co., Natick, MA, USA) was used. The study evaluated the diagnostic accuracy and adequacy of MOSE compared to the conventional technique and whether MOSE could optimize the number of passes during EUS-FNB.  Results : The analysis was performed on 76 patients (38 MOSE, 38 conventional). The overall diagnostic adequacy was 94.7% (72/76) and accuracy was 84.2% (64/76). The diagnostic accuracy was similar in the two groups: MOSE 86.8% (33/38 lesions), vs. conventional 81.6%, 31/38 lesions,  p  = 0.76). Regarding diagnostic adequacy, the MOSE technique was 97.4% (111/114 passes) compared to 92.1% (105/114 passes) with the conventional technique,  p  = 0.06. The accuracy increased according to the MOSE score evaluation: it was 43.5%, 65.5% and 78.3% in patients with score 1, score 2, and score 3, respectively. Moreover, if in the first two passes the MOSE score was 2 or 3, the accuracy was 82.6% (20/23), and upon adding a third pass, the accuracy increased to 87% (20/23), which was not significantly different from the general accuracy of the MOSE samples (86.8%) ( p  = 0.86).  Conclusions : The MOSE score showed a comparable diagnostic accuracy to the conventional technique. However, MOSE allows endoscopists to perform an inspective evaluation of the material, tends to perform better than the conventional technique in terms of diagnostic adequacy, and may potentially reduce the number of passes.",2022,"The diagnostic accuracy was similar in the two groups: MOSE 86.8% (33/38 lesions), vs. conventional 81.6%, 31/38 lesions,  p  = 0.76).","['76 consecutive patients performing EUS-FNB for pancreatic and extrapancreatic solid lesions, randomized by alternate allocation to macroscopic on-site evaluation (MOSE) (40 patients) or to a', '76 patients (38 MOSE, 38 conventional', 'Pancreatic and Extrapancreatic Solid Lesions']","['MOSE', 'Macroscopic On-Site Evaluation (MOSE', 'conventional technique', 'Endoscopic Ultrasound-Guided Fine-Needle Biopsy (EUS-FNB']","['diagnostic accuracy', 'MOSE score', 'overall diagnostic adequacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0057652', 'cui_str': 'di-beta-(morpholinoethyl)selenide'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0057652', 'cui_str': 'di-beta-(morpholinoethyl)selenide'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0057652', 'cui_str': 'di-beta-(morpholinoethyl)selenide'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",76.0,0.0194396,"The diagnostic accuracy was similar in the two groups: MOSE 86.8% (33/38 lesions), vs. conventional 81.6%, 31/38 lesions,  p  = 0.76).","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gaia', 'Affiliation': 'Gastroenterology, AOU Città della Salute e della Scienza di Torino, 10126 Turin, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Rizza', 'Affiliation': 'Gastroenterology, AOU Città della Salute e della Scienza di Torino, 10126 Turin, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Bruno', 'Affiliation': 'Gastroenterology, AOU Città della Salute e della Scienza di Torino, 10126 Turin, Italy.'}, {'ForeName': 'Davide Giuseppe', 'Initials': 'DG', 'LastName': 'Ribaldone', 'Affiliation': 'Gastroenterology, AOU Città della Salute e della Scienza di Torino, 10126 Turin, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Maletta', 'Affiliation': 'Pathology Unit, Department of Laboratory Medicine, AOU Città della Salute e della Scienza di Torino, 10126 Turin, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sacco', 'Affiliation': 'Gastroenterology, AOU Città della Salute e della Scienza di Torino, 10126 Turin, Italy.'}, {'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Pacchioni', 'Affiliation': 'Pathology Unit, Department of Laboratory Medicine, AOU Città della Salute e della Scienza di Torino, 10126 Turin, Italy.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Rizzi', 'Affiliation': 'Gastroenterology, AOU Città della Salute e della Scienza di Torino, 10126 Turin, Italy.'}, {'ForeName': 'Giorgio Maria', 'Initials': 'GM', 'LastName': 'Saracco', 'Affiliation': 'Gastroenterology, AOU Città della Salute e della Scienza di Torino, 10126 Turin, Italy.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Fagoonee', 'Affiliation': 'Molecular Biotechnology Center, Institute of Biostructure and Bioimaging (CNR), 10129 Turin, Italy.'}, {'ForeName': 'Claudio Giovanni', 'Initials': 'CG', 'LastName': 'De Angelis', 'Affiliation': 'Gastroenterology, AOU Città della Salute e della Scienza di Torino, 10126 Turin, Italy.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics12020428']
2352,35204414,Feasibility Study of Dose Modulation for Reducing Radiation Dose with Arms-Down Patient Position in Abdominal Computed Tomography.,"This study was carried out to demonstrate whether the radiation dose for patients in arms-down position can be reduced without affecting the diagnosis on abdominal computed tomography (CT). The patients were divided into two groups: group A, which included patients with arms-down position using dose modulation on, and group B, which included patients with arms-down position using dose modulation turned off. Quantitative evaluation was compared using Hounsfield units, standard deviation, and signal-to-noise ratio of the four regions. The qualitative evaluation was assessed for overall image quality, subjective image noise, and beam hardening artifacts. Dose evaluation for CT dose index (CTDI) and dose length product (DLP) was compared by comparing the CT images with dose modulation turned on and off. In the quantitative and qualitative evaluation, there was no statistically significant difference between groups A and B ( p  > 0.05). In the dose evaluation, the CT images with dose modulation turned off had significantly lower CTDI and DLP than the CT images with dose modulation turned on ( p  < 0.05). Our results suggest that, for the GE Revolution EVO CT scanner, turning off dose modulation and increasing the tube voltage can reduce the radiation dose for patients with the arms-down position without affecting the diagnosis. This study did not consider the change of tube potential according to the use of dose modulation, and we plan to conduct additional research in the future.",2022,"In the quantitative and qualitative evaluation, there was no statistically significant difference between groups A and B ( p  > 0.05).",[],[],"['CT dose index (CTDI) and dose length product (DLP', 'CTDI and DLP', 'overall image quality, subjective image noise, and beam hardening artifacts']",[],[],"[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0702118', 'cui_str': 'Abnormally hard consistency'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}]",,0.0223515,"In the quantitative and qualitative evaluation, there was no statistically significant difference between groups A and B ( p  > 0.05).","[{'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Shim', 'Affiliation': 'Department of Diagnostic Radiology, Severance Hospital, 50-1, Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Yong Eun', 'Initials': 'YE', 'LastName': 'Chung', 'Affiliation': 'Department of Radiology, Yonsei University Health System, Yonsei University College of Medicine, 50-1, Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Hyun-Woo', 'Initials': 'HW', 'LastName': 'Jeong', 'Affiliation': 'Department of Biomedical Engineering, Eulji University, 553, Sanseong-daero, Sujeong-gu, Seongnam-si 13135, Gyeonggi-do, Korea.'}, {'ForeName': 'Youngjin', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Radiological Science, Gachon University, 191, Hambakmoero, Yeonsu-gu, Incheon 21936, Korea.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics12020323']
2353,35204320,Volumetric Measurements in Lung Cancer Screening Reduces Unnecessary Low-Dose Computed Tomography Scans: Results from a Single-Center Prospective Trial on 4119 Subjects.,"This study aims to compare the low-dose computed tomography (LDCT) outcome and volume-doubling time (VDT) derived from the measured volume (MV) and estimated volume (EV) of pulmonary nodules (PNs) detected in a single-center lung cancer screening trial. MV, EV and VDT were obtained for prevalent pulmonary nodules detected at the baseline round of the bioMILD trial. The LDCT outcome (based on bioMILD thresholds) and VDT categories were simulated on PN- and screenee-based analyses. A weighted Cohen's kappa test was used to assess the agreement between diagnostic categories as per MV and EV, and 1583 screenees displayed 2715 pulmonary nodules. In the PN-based analysis, 40.1% PNs were included in different LDCT categories when measured by MV or EV. The agreements between MV and EV were moderate (κ = 0.49) and fair (κ = 0.37) for the LDCT outcome and VDT categories, respectively. In the screenee-based analysis, 46% pulmonary nodules were included in different LDCT categories when measured by MV or EV. The agreements between MV and EV were moderate (κ = 0.52) and fair (κ = 0.34) for the LDCT outcome and VDT categories, respectively. Within a simulated lung cancer screening based on a recommendation by estimated volumetry, the number of LDCTs performed for the evaluation of pulmonary nodules was higher compared with in prospective volumetric management.",2022,"The agreements between MV and EV were moderate (κ = 0.52) and fair (κ = 0.34) for the LDCT outcome and VDT categories, respectively.",['4119 Subjects'],"['Lung Cancer Screening Reduces Unnecessary Low-Dose Computed Tomography Scans', 'low-dose computed tomography (LDCT']","['MV, EV and VDT', 'volume (MV) and estimated volume (EV) of pulmonary nodules (PNs', 'volume-doubling time (VDT']",[],"[{'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034079', 'cui_str': 'Nodule of lung'}]",,0.0888493,"The agreements between MV and EV were moderate (κ = 0.52) and fair (κ = 0.34) for the LDCT outcome and VDT categories, respectively.","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Milanese', 'Affiliation': 'Radiological Sciences, Department of Medicine and Surgery (DiMeC), University Hospital of Parma, 43126 Parma, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Sabia', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale Tumori of Milan, 20133 Milan, Italy.'}, {'ForeName': 'Roberta Eufrasia', 'Initials': 'RE', 'LastName': 'Ledda', 'Affiliation': 'Radiological Sciences, Department of Medicine and Surgery (DiMeC), University Hospital of Parma, 43126 Parma, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Sestini', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale Tumori of Milan, 20133 Milan, Italy.'}, {'ForeName': 'Alfonso Vittorio', 'Initials': 'AV', 'LastName': 'Marchianò', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale Tumori of Milan, 20133 Milan, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Sverzellati', 'Affiliation': 'Radiological Sciences, Department of Medicine and Surgery (DiMeC), University Hospital of Parma, 43126 Parma, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Pastorino', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale Tumori of Milan, 20133 Milan, Italy.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics12020229']
2354,35204805,Placebo-Related Adverse Events in Rheumatoid Arthritis.,"Prospective, double-blind, randomized, placebo-controlled studies are considered to provide the highest quality of interventional evidence. This meta-analysis summarizes the frequencies of adverse events according to the Medical Dictionary for Regulatory Activities (MedDRA) in the placebo arms of 101 such studies in rheumatoid arthritis, including a total of 17,150 patients in the placebo arms and 37,819 patients in the verum arms. Placebo-treated patients reported more than one adverse event in a median of 55.0%, 65.5%, and 72.5% (compared to 72.3% in the verum arms), and a serious adverse event in 2.5%, 5.8%, and 8.6% (compared to 5.9% in the verum arms), with stable doses of corticosteroids, conventional synthetic disease-modifying antirheumatic drugs (DMARDs), and biological DMARDs as background therapies, respectively. Odds ratios were comparable between placebo and verum arms for nausea (1.00 with 95% confidence interval (CI) 0.86-1.17), for hepatobiliary disorders (1.08 with CI 0.85-1.36), for abnormal hepatic functions (1.09 with CI 0.83-1.44), and general disorders and administration site conditions (1.39 with CI 0.95-2.03). A publication bias has to be assumed for nausea ( p  = 0.018; Egger's test), diarrhoea ( p  = 0.022), and serious infections and infestations ( p  = 0.009). In conclusion, patients should be aware that ""adverse events"" may occur even with placebo medication, independent from an additional verum medication added to the background therapy. Further studies are warranted to respect and overcome the psychological and other issues related to these placebo-related ""adverse events"".",2022,"A publication bias has to be assumed for nausea ( p  = 0.018; Egger's test), diarrhoea ( p  = 0.022), and serious infections and infestations ( p  = 0.009).","['17,150 patients in the placebo arms and 37,819 patients in the verum arms', 'Rheumatoid Arthritis']","['Placebo', 'placebo']","['serious adverse event', 'nausea', 'hepatobiliary disorders', 'diarrhoea', 'adverse event', 'general disorders and administration site conditions', 'abnormal hepatic functions', 'Odds ratios']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0267792', 'cui_str': 'Hepatobiliary disease'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0851362', 'cui_str': 'General disorders and administration site conditions'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",,0.815636,"A publication bias has to be assumed for nausea ( p  = 0.018; Egger's test), diarrhoea ( p  = 0.022), and serious infections and infestations ( p  = 0.009).","[{'ForeName': 'Ratna Shree', 'Initials': 'RS', 'LastName': 'Sharma', 'Affiliation': 'Rheumatology Research Group, Department of Internal Medicine, Clinic II, Medical University of Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Pallua', 'Affiliation': 'University Hospital for Orthopedics and Traumatology, Medical University of Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schirmer', 'Affiliation': 'Rheumatology Research Group, Department of Internal Medicine, Clinic II, Medical University of Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria.'}]",Biomolecules,['10.3390/biom12020303']
2355,35204604,Evaluation of a Whole-Liver Dixon-Based MRI Approach for Quantification of Liver Fat in Patients with Type 2 Diabetes Treated with Two Isocaloric Different Diets.,"Dixon-based methods for the detection of fatty liver have the advantage of being non-invasive, easy to perform and analyze, and to provide a whole-liver coverage during the acquisition. The aim of the study was to assess the feasibility of a whole-liver Dixon-based approach for liver fat quantification in type 2 diabetes (T2D) patients who underwent two different isocaloric dietary treatments: a diet rich in monosaturated fatty acids (MUFA) and a multifactorial diet. Thirty-nine T2D patients were randomly assigned to MUFA diet ( n  = 21) and multifactorial diet ( n  = 18). The mean values of the proton density fat fraction (PDFF) over the whole liver and over the ROI corresponding to that chosen for MRS were compared to MRS-PDFF using Spearman's correlation (ρ). Before-after changes in percentage of liver volume corresponding to MRI-PDFF above thresholds associated with hepatic steatosis (LV% TH , with TH = 5.56%, 7.97% and 8.8%) were considered to assess the proposed approach and compared between diets using Wilcoxon rank-sum test. Statistical significance set at  p  < 0.05. A strong linear relationship was found between MRS-PDFF and MRI-PDFFs (ρ = 0.85,  p  < 0.0001). Changes in LV% TH%  were significantly higher ( p  < 0.05) in the multifactorial diet than in MUFA diet (25% vs. 9%, 35% vs. 12%, and 38% vs. 13% decrease, respectively, for TH = 5.56%, 7.97%, and 8.8%) and this was reproducible compared to results obtained using the standard liver fat analysis. A volumetric approach based on Dixon method could be an effective, non-invasive technique that could be used for the quantitative analysis of hepatic steatosis in T2D patients.",2022,"Changes in LV% TH%  were significantly higher ( p  < 0.05) in the multifactorial diet than in MUFA diet (25% vs. 9%, 35% vs. 12%, and 38% vs. 13% decrease, respectively, for TH = 5.56%, 7.97%, and 8.8%) and this was reproducible compared to results obtained using the standard liver fat analysis.","['T2D patients', 'type 2 diabetes (T2D) patients who underwent two different', 'Patients with Type 2 Diabetes Treated with Two Isocaloric Different Diets', 'Thirty-nine']","['isocaloric dietary treatments: a diet rich in monosaturated fatty acids (MUFA) and a multifactorial diet', 'MUFA diet', 'T2D', 'whole-liver Dixon-based approach', 'multifactorial diet', 'Whole-Liver Dixon-Based MRI Approach']","['MRS-PDFF and MRI-PDFFs', 'mean values of the proton density fat fraction (PDFF', 'Changes in LV% TH']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3816447', 'cui_str': '39'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0440791', 'cui_str': 'Whole liver'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C4761214', 'cui_str': 'Magnetic resonance proton density fat fraction measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",39.0,0.0130136,"Changes in LV% TH%  were significantly higher ( p  < 0.05) in the multifactorial diet than in MUFA diet (25% vs. 9%, 35% vs. 12%, and 38% vs. 13% decrease, respectively, for TH = 5.56%, 7.97%, and 8.8%) and this was reproducible compared to results obtained using the standard liver fat analysis.","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Brancato', 'Affiliation': 'IRCCS Synlab SDN, 80143 Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Della Pepa', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Naples, Italy.'}, {'ForeName': 'Lutgarda', 'Initials': 'L', 'LastName': 'Bozzetto', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Naples, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Naples, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Annuzzi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Naples, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Basso', 'Affiliation': 'IRCCS Synlab SDN, 80143 Naples, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cavaliere', 'Affiliation': 'IRCCS Synlab SDN, 80143 Naples, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Salvatore', 'Affiliation': 'IRCCS Synlab SDN, 80143 Naples, Italy.'}, {'ForeName': 'Angela Albarosa', 'Initials': 'AA', 'LastName': 'Rivellese', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Naples, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Monti', 'Affiliation': 'Institute of Biostructures and Bioimaging, National Research Council, 80145 Naples, Italy.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics12020514']
2356,35205165,"Effect of Concurrent Resistance Training on Lower Body Strength, Leg Kick Swimming, and Sport-Specific Performance in Competitive Swimmers.","The present study investigated the effect of 9 weeks of combined resistance training (aquatic and dry land resistance) on maximum lower body strength, leg kick, and swimming performance in competitive swimmers. Twenty-two male national competitive swimmers were randomly assigned into two groups: experimental group (EG: age = 16.2 ± 0.3 years) or control group (CG: age = 16.3 ± 0.3 years). The EG performed a combined resistance training while the CG group completed their usual training. One repetition maximum (1RM) back squat, 30 m leg kick, and swimming performance (100 m front crawl, start and turn) were evaluated in pre and post test. The findings showed a significant increase in 1RM back squat (d = 1.90; 14.94 ± 1.32%) after 9 weeks of combined resistance training. In addition, ours results revealed a significant improvement in 30 m leg kick swimming (d = 2.11; 5.84 ± 0.16%) and in all swimming, start and turn performances (d = 1.83 to 2.77; 2.69 ± 0.18% to 15.14 ± 1.06%) in EG. All dependent variables remained unchanged in the CG. To sum up, 9 weeks of combined resistance training can improve the maximum lower body strength and leg kick swimming performance. These improvements can be the essential factors that subsequently positively affected swimming, start and turn performances. Combined resistance training is an effective training that can be incorporated by coaches and swimmers into their programs to improve strength, leg kick swimming, and, subsequently, swimming performance in competitive swimmers.",2022,"To sum up, 9 weeks of combined resistance training can improve the maximum lower body strength and leg kick swimming performance.","['Competitive Swimmers', 'competitive swimmers', 'Twenty-two male national competitive swimmers']","['combined resistance training', 'Concurrent Resistance Training', 'combined resistance training (aquatic and dry land resistance', 'Combined resistance training']","['One repetition maximum (1RM) back squat, 30 m leg kick, and swimming performance (100 m front crawl, start and turn', '1RM back squat', 'maximum lower body strength, leg kick, and swimming performance', 'maximum lower body strength and leg kick swimming performance', 'Lower Body Strength, Leg Kick Swimming, and Sport-Specific Performance', '30 m leg kick swimming']","[{'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0015737', 'cui_str': 'National Government'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0235042', 'cui_str': 'Does crawl'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",22.0,0.0108457,"To sum up, 9 weeks of combined resistance training can improve the maximum lower body strength and leg kick swimming performance.","[{'ForeName': 'Sofiene', 'Initials': 'S', 'LastName': 'Amara', 'Affiliation': 'Higher Institute of Sport and Physical Education of Ksar-Said, University of La Manouba, Tunis 2010, Tunisia.'}, {'ForeName': 'Tiago Manuel', 'Initials': 'TM', 'LastName': 'Barbosa', 'Affiliation': 'Research Center in Sport, Health and Human Development, 5000-801 Vila Real, Portugal.'}, {'ForeName': 'Oussama Gaied', 'Initials': 'OG', 'LastName': 'Chortane', 'Affiliation': 'Higher Institute of Sport and Physical Education of Ksar-Said, University of La Manouba, Tunis 2010, Tunisia.'}, {'ForeName': 'Raouf', 'Initials': 'R', 'LastName': 'Hammami', 'Affiliation': 'Higher Institute of Sport and Physical Education of Ksar-Said, University of La Manouba, Tunis 2010, Tunisia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Attia', 'Affiliation': 'Higher Institute of Sport and Physical Education of Ksar-Said, University of La Manouba, Tunis 2010, Tunisia.'}, {'ForeName': 'Sabri Gaied', 'Initials': 'SG', 'LastName': 'Chortane', 'Affiliation': 'Higher Institute of Sport and Physical Education of Ksar-Said, University of La Manouba, Tunis 2010, Tunisia.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'van den Tillaar', 'Affiliation': 'Department of Sport Sciences and Physical Education, Nord University, 7600 Levanger, Norway.'}]",Biology,['10.3390/biology11020299']
2357,35205156,Effectiveness of a 12-Week Multi-Component Training Program with and without Transcranial Direct-Current Stimulation (tDCS) on Balance to Prevent Falls in Community-Dwelling Older Adults: A Study Protocol.,"Approximately one-third of elderly people aged over 65 who live in the community experience falls every year, with the proportion increasing with age. Moreover, of those who fall, about half will fall again in the following year. The falls' consequences include disability, morbidity, and mortality. Although many external and internal factors lead to falls, balance issues play a major role. Multi-component training programs (McTP) usually combine balance, strength, cardiorespiratory fitness, and flexibility, with studies reporting multiple benefits on the health-related quality of life. Halo Sport is a transcranial direct-current stimulation (tDCS) device with promising results for gait performance. This study aims to test the effectiveness of the introduction of a tCDS device to an McTP to prevent falls in older adults. The sample will consist of 46 people aged 65 years or older, randomly assigned to experimental (n = 23) and control (n = 23) groups. The experimental group will perform the McTP while wearing tDCS, and the control group will perform McTP without the device, for three sessions per week over 12 weeks. The main measures will provide information about (1) safety, (2) applicability, (3) balance, (4) number of falls, (5) physical fitness, (6) risk of falling, (7) fear of falling, (8) health-related quality of life, and (9) cognitive function. Among the practical implications of this program, it is intended to provide data on its safety and effectiveness to be implemented in different resources as a tool for the prevention of falls.",2022,This study aims to test the effectiveness of the introduction of a tCDS device to an McTP to prevent falls in older adults.,"['elderly people aged over 65 who live in the community experience falls every year, with the proportion increasing with age', 'Community-Dwelling Older Adults', 'older adults', '46 people aged 65 years or older, randomly assigned to experimental (n = 23) and control (n = 23) groups']","['Halo Sport', 'tCDS device', 'transcranial direct-current stimulation (tDCS) device', 'McTP', '12-Week Multi-Component Training Program with and without Transcranial Direct-Current Stimulation (tDCS', 'Multi-component training programs (McTP']","['provide information about (1) safety, (2) applicability, (3) balance, (4) number of falls, (5) physical fitness, (6) risk of falling, (7) fear of falling, (8) health-related quality of life, and (9) cognitive function', 'disability, morbidity, and mortality']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0181278', 'cui_str': 'Halo brace'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.00751662,This study aims to test the effectiveness of the introduction of a tCDS device to an McTP to prevent falls in older adults.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Muñoz-Bermejo', 'Affiliation': 'Social Impact and Innovation in Health Research Group (InHEALTH), University of Extremadura, 06800 Mérida, Spain.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Barrios-Fernandez', 'Affiliation': 'Social Impact and Innovation in Health Research Group (InHEALTH), University of Extremadura, 06800 Mérida, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Carlos-Vivas', 'Affiliation': 'Promoting a Healthy Society Research Group (PHeSO), Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Mendoza-Muñoz', 'Affiliation': 'Promoting a Healthy Society Research Group (PHeSO), Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Pastor-Cisneros', 'Affiliation': 'Promoting a Healthy Society Research Group (PHeSO), Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Merellano-Navarro', 'Affiliation': 'EFISAL Resarch Group, Universidad Autónoma de Chile, Talca 3460000, Chile.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Gianikellis', 'Affiliation': 'Biomecánica del Movimiento Humano y Ergonomía Research Group (BIOERGON), Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'José Carmelo', 'Initials': 'JC', 'LastName': 'Adsuar', 'Affiliation': 'Promoting a Healthy Society Research Group (PHeSO), Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}]",Biology,['10.3390/biology11020290']
2358,35205153,Angiogenin Levels and Their Association with Cardiometabolic Indices Following Vitamin D Status Correction in Saudi Adults.,"Angiogenin (ANG), a multifunctional protein known to induce blood vessel formation, is a potential biomarker for cardiovascular diseases; however, whether it is affected by vitamin D supplementation is not known. This interventional study in vitamin D-deficient Saudi adults was designed to investigate it. A total of 100 vitamin D-deficient Saudi adults aged 30-50 years were randomly selected to undergo 6-month vitamin D supplementation. Circulating levels of fasting glucose, lipids, vitamin D, apolipoproteins (AI, AII, B, CI, CII, CIII, E, and H), and ANG were measured using commercially available assays at baseline and after six months. Overall, vitamin D levels increased significantly post intervention. With this, levels of apo-CIII and apo-E significantly increased ( p -values of 0.001 and 0.009, respectively) with a significant parallel decrease in apo-B ( p  = 0.003). ANG levels were significantly positively associated with most apolipoproteins and inversely correlated with HDL-cholesterol. Post intervention, the changes in ANG levels were positively correlated with apo-E (r = 0.32;  p  < 0.01 in all subjects and r = 0.40;  p  < 0.05 in males). Vitamin D supplementation may modestly affect ANG levels. The association observed between ANG and apo-E is worthy of further investigation since both biomarkers have been linked to neurodegenerative disorders.",2022,"With this, levels of apo-CIII and apo-E significantly increased ( p -values of 0.001 and 0.009, respectively) with a significant parallel decrease in apo-B ( p  = 0.003).","['Saudi Adults', 'deficient Saudi adults', '100 vitamin D-deficient Saudi adults aged 30-50 years']","['Vitamin D Status Correction', 'Angiogenin (ANG', 'vitamin D', 'vitamin D supplementation', 'Vitamin D supplementation']","['changes in ANG levels', 'levels of apo-CIII and apo-E', 'HDL-cholesterol', 'ANG levels', 'Circulating levels of fasting glucose, lipids, vitamin D, apolipoproteins (AI, AII, B, CI, CII, CIII, E, and H), and ANG', 'Overall, vitamin D levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0051844', 'cui_str': 'Angiogenin'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0051844', 'cui_str': 'Angiogenin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0003595', 'cui_str': 'Apolipoprotein E'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",100.0,0.13837,"With this, levels of apo-CIII and apo-E significantly increased ( p -values of 0.001 and 0.009, respectively) with a significant parallel decrease in apo-B ( p  = 0.003).","[{'ForeName': 'Ghadeer M', 'Initials': 'GM', 'LastName': 'Aldawsari', 'Affiliation': 'Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Sabico', 'Affiliation': 'Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Abir A', 'Initials': 'AA', 'LastName': 'Alamro', 'Affiliation': 'Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Alenad', 'Affiliation': 'Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Kaiser', 'Initials': 'K', 'LastName': 'Wani', 'Affiliation': 'Chair for Biomarkers of Chronic Diseases, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Alnaami', 'Affiliation': 'Chair for Biomarkers of Chronic Diseases, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Malak N K', 'Initials': 'MNK', 'LastName': 'Khattak', 'Affiliation': 'Chair for Biomarkers of Chronic Diseases, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Mohammad S', 'Initials': 'MS', 'LastName': 'Masoud', 'Affiliation': 'Chair for Biomarkers of Chronic Diseases, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Nasser M', 'Initials': 'NM', 'LastName': 'Al-Daghri', 'Affiliation': 'Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Majed S', 'Initials': 'MS', 'LastName': 'Alokail', 'Affiliation': 'Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}]",Biology,['10.3390/biology11020286']
2359,35205134,"Vibrating Exercise Equipment in Middle-Age and Older Women with Chronic Low Back Pain and Effects on Bioelectrical Activity, Range of Motion and Pain Intensity: A Randomized, Single-Blinded Sham Intervention Study.","Background:  Chronic low back pain (CLBP) is one of the most common musculoskeletal disorders. Physical activity (PA) is often recommended as part of the management of CLBP, but to date, no one particular exercise has been shown to be superior. Vibrating exercise equipment (VEE) is widely available and used despite little scientific evidence to support its effectiveness in the prevention and treatment of musculoskeletal problems. The aim of this study was to evaluate the efficiency of using VEE compared with sham-VEE in women with CLBP.  Methods:  A randomized (1:1 randomization scheme) single-blinded sham-controlled intervention study was conducted. Through simple randomization, 92 women aged 49-80 years were assigned to one of two groups: VEE (the experimental group) and sham-VEE (the control group). The VEE and sham-VEE intervention consisted of aerobic exercises with specific handheld equipment. Both groups performed physical activity twice weekly for 10 weeks. The erector spinae muscles' bioelectrical activity (using an eight-channel electromyograph MyoSystem 1400L), lumbar range of motion (Schober's test) and pain intensity (visual analog scale) were measured in all participants at baseline and after 10 weeks.  Results : There was a significant decrease in the bioelectrical activity of the erector spinae muscles during flexion movement (left: Me = 18.2 before; Me = 14.1 after;  p  = 0.045; right: Me = 15.4 before; Me = 12.6 after;  p  = 0.010), rest at maximum flexion (left: Me = 18.1 before; Me = 12.5 after;  p  = 0.038), extension movement (right: Me = 21.8 before; Me = 20.2 after;  p  = 0.031) and rest in a prone position (right: Me = 3.5 before; Me = 3.2 after; 0.049); an increase in lumbar range of motion (Me = 17.0 before; Me = 18.0 after;  p  = 0.0017) and a decrease in pain intensity (Me = 4.0 before; Me = 1.0 after;  p  = 0.001) following a program of PA in the VEE group.  Conclusions:  No significant changes were found in intergroup comparisons. The beneficial changes regarding decreased subjective pain sensation in the VEE and sham-VEE groups may be due to participation in systematic physical activity. However, PA with vibrating exercise equipment could be a prospective strategy for increasing lumbar range of motion and for decreasing pain and erector spinae muscle activity in people with CLBP.",2022,There was a significant decrease in the bioelectrical activity of the erector spinae muscles during flexion movement (left: Me = 18.2 before; Me = 14.1 after;  p  = 0.045; right:,"['women with CLBP', 'Middle-Age and Older Women with Chronic Low Back Pain', '92 women aged 49-80 years', 'people with CLBP']","['Vibrating Exercise Equipment', 'VEE (the experimental group) and sham-VEE', 'sham-VEE', 'VEE', 'aerobic exercises with specific handheld equipment', 'Vibrating exercise equipment (VEE']","['subjective pain sensation', 'Physical activity (PA', 'bioelectrical activity', 'Bioelectrical Activity, Range of Motion and Pain Intensity', ""lumbar range of motion (Schober's test) and pain intensity (visual analog scale"", 'pain intensity', 'lumbar range of motion', 'extension movement']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0014049', 'cui_str': 'Venezuelan equine encephalomyelitis virus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0430750', 'cui_str': 'Modified Schober test'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",92.0,0.0488744,There was a significant decrease in the bioelectrical activity of the erector spinae muscles during flexion movement (left: Me = 18.2 before; Me = 14.1 after;  p  = 0.045; right:,"[{'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Zurek', 'Affiliation': 'Department of Biostructure, University School of Physical Education, I.J. Paderewskiego 35, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Martyna', 'Initials': 'M', 'LastName': 'Kasper-Jędrzejewska', 'Affiliation': 'Institute of Health Sciences, University of Opole, Katowicka 68, 45-060 Opole, Poland.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Dobrowolska', 'Affiliation': 'Institute of Health Sciences, University of Opole, Katowicka 68, 45-060 Opole, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Mroczek', 'Affiliation': 'Institute of Health Sciences, University of Opole, Katowicka 68, 45-060 Opole, Poland.'}, {'ForeName': 'Gerda', 'Initials': 'G', 'LastName': 'Delaunay', 'Affiliation': 'Department of Biostructure, University School of Physical Education, I.J. Paderewskiego 35, 51-612 Wroclaw, Poland.'}, {'ForeName': 'Kuba', 'Initials': 'K', 'LastName': 'Ptaszkowski', 'Affiliation': 'Department of Clinical Biomechanics and Physiotherapy in Motor System Disorders, Faculty of Health Science, Wroclaw Medical University, Grunwaldzka 2, 50-355 Wroclaw, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Halski', 'Affiliation': 'Institute of Health Sciences, University of Opole, Katowicka 68, 45-060 Opole, Poland.'}]",Biology,['10.3390/biology11020268']
2360,35205636,A Randomized Prospective Non-Inferiority Trial of Sentinel Lymph Node Biopsy in Early Breast Cancer: Blue Dye Compared with Indocyanine Green Fluorescence Tracer.,"BACKGROUND


Indocyanine green (ICG) is a promising tracer for sentinel lymph node biopsy in early breast cancer. This randomized study was conducted to evaluate sentinel lymph node biopsy with ICG compared with blue dye as a tracer in woman with early breast cancer without any sign of lymph node invasion.
METHODS


Between January 2019 and November 2020, 240 consecutive women with early breast cancer were enrolled and randomized to sentinel lymph node biopsy using ICG or blue dye. The primary endpoint was the sentinel lymph node detection rate in both arms.
RESULTS


ICG was used in 121 patients and detected sentinel lymph nodes in all patients (detection rate, 100%; 95% CI: 96.9-100.0) while blue dye was used in 119 patients and detected sentinel lymph nodes in 116 patients (detection rate: 97.5%, 95% CI: 92.9-99.1). This analysis indicated the non-inferiority of ICG vs. blue dye tracer (90%CI: -1.9-6.9;  p  = 0.0009).
CONCLUSION


ICG represents a new promising tracer to detect sentinel lymph nodes in early breast cancer with a detection rate similar to other conventional tracers, and is associated with easy learning and low cost. Our result suggest that this technique is a good alternative to avoid radioactive isotope manipulation.",2022,"This analysis indicated the non-inferiority of ICG vs. blue dye tracer (90%CI: -1.9-6.9;  p  = 0.0009).
","['woman with early breast cancer without any sign of lymph node invasion', 'Between January 2019 and November 2020, 240 consecutive women with early breast cancer', 'Early Breast Cancer']","['ICG', 'sentinel lymph node biopsy using ICG or blue dye', 'Indocyanine green (ICG', 'blue dye', 'Sentinel Lymph Node Biopsy', 'Indocyanine Green Fluorescence Tracer']","['sentinel lymph node detection rate', 'sentinel lymph nodes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}]","[{'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",240.0,0.103922,"This analysis indicated the non-inferiority of ICG vs. blue dye tracer (90%CI: -1.9-6.9;  p  = 0.0009).
","[{'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Coibion', 'Affiliation': 'Gynecology Department, CHC Montlegia, 4020 Liege, Belgium.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Olivier', 'Affiliation': 'Medical Oncology Department, University Hospital of Liege, 4020 Liege, Belgium.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Courtois', 'Affiliation': 'Medical Oncology Department, University Hospital of Liege, 4020 Liege, Belgium.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Maes', 'Affiliation': 'Biostatistics and Medico-Economic Information Department, University Hospital of Liège, 4020 Liege, Belgium.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Jossa', 'Affiliation': 'Anatomo-Pathology Department, CHC Montlegia, 4020 Liege, Belgium.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Jerusalem', 'Affiliation': 'Medical Oncology Department, University Hospital of Liege, 4020 Liege, Belgium.'}]",Cancers,['10.3390/cancers14040888']
2361,35205611,Administering Docetaxel for Metastatic Hormone-Sensitive Prostate Cancer 1-6 Days Compared to More Than 14 Days after the Start of LHRH Agonist Is Associated with Better Clinical Outcomes Due to Androgen Flare.,"Docetaxel, when given at the beginning of androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (MHSPC), results in significantly longer overall survival than ADT alone. We aimed to investigate if the delivery of the first dose of docetaxel during the testosterone flare associated with LHRH initiation results in better clinical outcomes, as testosterone induces mitosis of prostate cancer cells, and docetaxel specifically targets cells in mitosis. We analyzed data from the CHAARTED trial which randomized MHSPC patients to ADT alone or ADT plus docetaxel. We included only patients treated with LHRH agonist and docetaxel ( n  = 379). The only cutoff that resulted in differences in treatment outcomes was between patients who started docetaxel 1-6 days ( n  = 18) compared to more than 14 days from LHRH initiation ( n  = 297). Actuarial median overall survival was 72 versus 57 months ( p  = 0.2); progression-free survival was 49 versus 17 months ( p  = 0.06), and freedom from castrate-resistant prostate cancer was 51 versus 18 months ( p  = 0.04) for patients who started docetaxel 1-6 days compared to more than 14 days from LHRH initiation, respectively. Administering docetaxel 1-6 days from the initiation of LHRH agonist for patients with MHSPC could be associated with improved clinical outcomes.",2022,"Actuarial median overall survival was 72 versus 57 months ( p  = 0.2); progression-free survival was 49 versus 17 months ( p  = 0.06), and freedom from castrate-resistant prostate cancer was 51 versus 18 months ( p  = 0.04) for patients who started docetaxel 1-6 days compared to more than 14 days from LHRH initiation, respectively.","['patients with metastatic hormone-sensitive prostate cancer (MHSPC', 'patients with MHSPC', 'Metastatic Hormone-Sensitive Prostate Cancer', ' n  = 379']","['LHRH Agonist', 'androgen deprivation therapy (ADT', 'LHRH agonist and docetaxel', 'Docetaxel', 'ADT alone or ADT plus docetaxel', 'docetaxel']","['Actuarial median overall survival', 'overall survival', 'progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.193635,"Actuarial median overall survival was 72 versus 57 months ( p  = 0.2); progression-free survival was 49 versus 17 months ( p  = 0.06), and freedom from castrate-resistant prostate cancer was 51 versus 18 months ( p  = 0.04) for patients who started docetaxel 1-6 days compared to more than 14 days from LHRH initiation, respectively.","[{'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Nasser', 'Affiliation': 'Department of Radiation Oncology, School of Medicine, University of Maryland, Baltimore, MD 21201, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, School of Medicine, University of Maryland, Baltimore, MD 21201, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Scanlon', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, University of Maryland, Baltimore, MD 21201, USA.'}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Mishra', 'Affiliation': 'Department of Radiation Oncology, School of Medicine, University of Maryland, Baltimore, MD 21201, USA.'}, {'ForeName': 'Jason K', 'Initials': 'JK', 'LastName': 'Molitoris', 'Affiliation': 'Department of Radiation Oncology, School of Medicine, University of Maryland, Baltimore, MD 21201, USA.'}]",Cancers,['10.3390/cancers14040864']
2362,35205997,Vacuum Packaging Can Extend Fresh Color Characteristics of Beef Steaks during Simulated Display Conditions.,"Packaging technology is evolving, and the objectives of this study were to evaluate instrumental surface color, expert color evaluation, and lipid oxidation (TBARS) on beef  longissimus lumborum  steaks packaged in vacuum-ready packaging (VRF) or polyvinyl chloride (PVC) overwrap packaging. Paired strip loins (Institutional Meat Purchasing Specifications # 180) were cut into 2.54-cm-thick steaks and assigned randomly to one of two packaging treatments, VRF or PVC. Steaks packaged in VRF were lighter in color ( p  < 0.05) as the display period increased, whereas steaks packaged in PVC became darker ( p  < 0.05). Redness (a*) values were greater ( p  < 0.05) for PVC steaks until day 5, whereas VRF steaks had a greater ( p  < 0.05) surface redness from day 10 to 35 of the display period. Calculated spectral values of red to brown were greater ( p  < 0.05) for steaks in VRF than PVC. In addition, expert color evaluators confirmed VRF steaks were less brown and less discolored ( p  < 0.05) from day 5 to 35 of the display. Nonetheless, lipid oxidation was greater ( p  < 0.05) for PVC steaks from day 10 through day 35 of the display. Results from this study suggest that the use of vacuum packaging for beef steaks is plausible for maintaining surface color characteristics during extended display periods.",2022,"Redness (a*) values were greater ( p  < 0.05) for PVC steaks until day 5, whereas VRF steaks had a greater ( p  < 0.05) surface redness from day 10 to 35 of the display period.",[],"['polyvinyl chloride (PVC', 'VRF or PVC']","['Redness', 'Calculated spectral values of red to brown', 'surface redness', 'lipid oxidation', 'VRF steaks']",[],"[{'cui': 'C0032624', 'cui_str': 'Polyvinyl chloride'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",180.0,0.0366505,"Redness (a*) values were greater ( p  < 0.05) for PVC steaks until day 5, whereas VRF steaks had a greater ( p  < 0.05) surface redness from day 10 to 35 of the display period.","[{'ForeName': 'Tristan M', 'Initials': 'TM', 'LastName': 'Reyes', 'Affiliation': 'Department of Animal Sciences, Auburn University, Auburn, AL 36849, USA.'}, {'ForeName': 'Madison P', 'Initials': 'MP', 'LastName': 'Wagoner', 'Affiliation': 'Department of Animal Sciences, Auburn University, Auburn, AL 36849, USA.'}, {'ForeName': 'Virginia E', 'Initials': 'VE', 'LastName': 'Zorn', 'Affiliation': 'Department of Animal Sciences, Auburn University, Auburn, AL 36849, USA.'}, {'ForeName': 'Madison M', 'Initials': 'MM', 'LastName': 'Coursen', 'Affiliation': 'Department of Animal Sciences, Auburn University, Auburn, AL 36849, USA.'}, {'ForeName': 'Barney S', 'Initials': 'BS', 'LastName': 'Wilborn', 'Affiliation': 'Department of Animal Sciences, Auburn University, Auburn, AL 36849, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Bonner', 'Affiliation': 'Winpak Ltd., 100 Saulteaux Crescent, Winnipeg, MB R3J 3T3, Canada.'}, {'ForeName': 'Terry D', 'Initials': 'TD', 'LastName': 'Brandebourg', 'Affiliation': 'Department of Animal Sciences, Auburn University, Auburn, AL 36849, USA.'}, {'ForeName': 'Soren P', 'Initials': 'SP', 'LastName': 'Rodning', 'Affiliation': 'Department of Animal Sciences, Auburn University, Auburn, AL 36849, USA.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Sawyer', 'Affiliation': 'Department of Animal Sciences, Auburn University, Auburn, AL 36849, USA.'}]","Foods (Basel, Switzerland)",['10.3390/foods11040520']
2363,35206255,The Influence of the Pharmacists' Training on the Quality and Comprehensiveness of Professional Advice Given in the Field of Inhalation Techniques in Community Pharmacies in Poland.,"BACKGROUND


Following the example of other countries, it is very important to educate patients on the correct use of inhalers by properly trained healthcare professionals, including pharmacists.
OBJECTIVES


The aim of the study was to assess the quality and comprehensiveness of professional advice given by pharmacists on the use of inhalers, which was determined by the pharmacists' level of training.
METHODS


The study was conducted from June 2019 to March 2020. 150 pharmacists from Poznan and Warsaw (Poland) were involved. Before the study began, the professional education of 240 pharmacists was conducted in Warsaw to implement standard operating procedures. The study used the model of a mystery shopper.
RESULTS


The conversation with a trained pharmacist lasted on average 5.5 min, with an untrained one-3.0 min ( p  < 0.0001). Placebo inhalers were used more often by trained pharmacists during patients' education ( p  < 0.0001). Moreover, 10.3% of untrained pharmacists did not provide any education. Additionally, untrained employees' quality of advice was assessed on an average of 3.5 points, while trained ones-7.6 points ( p  < 0.0001).
CONCLUSIONS


This study has shown that there is a need for professional training among pharmacists in Poland, which translates into better patient education in the field of inhalation techniques.",2022,Placebo inhalers were used more often by trained pharmacists during patients' education ( p  < 0.0001).,"['June 2019 to March 2020', 'Community Pharmacies in Poland', '150 pharmacists from Poznan and Warsaw (Poland) were involved']",['Placebo'],"['quality and comprehensiveness of professional advice', ""untrained employees' quality of advice""]","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]",,0.0430107,Placebo inhalers were used more often by trained pharmacists during patients' education ( p  < 0.0001).,"[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Waszyk-Nowaczyk', 'Affiliation': 'Pharmacy Practice Division, Chair and Department of Pharmaceutical Technology, Poznan University of Medical Sciences, 6 Grunwaldzka Street, 60-780 Poznan, Poland.'}, {'ForeName': 'Weronika', 'Initials': 'W', 'LastName': 'Guzenda', 'Affiliation': 'Pharmacy Practice Division, Chair and Department of Pharmaceutical Technology, Poznan University of Medical Sciences, 6 Grunwaldzka Street, 60-780 Poznan, Poland.'}, {'ForeName': 'Patrycja', 'Initials': 'P', 'LastName': 'Targosz', 'Affiliation': ""Student's Pharmaceutical Care Group, Department of Pharmaceutical Technology, Pharmacy Practice Division, Poznan University of Medical Sciences, 6 Grunwaldzka Street, 60-780 Poznan, Poland.""}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Byliniak', 'Affiliation': 'Polish Pharmaceutical Chamber, 77 lok. 6 Żeromskiego Street, 01-882 Warsaw, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Plewka', 'Affiliation': 'Pharmacy Practice Division, Chair and Department of Pharmaceutical Technology, Poznan University of Medical Sciences, 6 Grunwaldzka Street, 60-780 Poznan, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Dąbrowiecki', 'Affiliation': 'Department of Infectious Diseases and Allergology, Military Institute of Medicine, 128 Szaserów Street, 04-141 Warsaw, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Michalak', 'Affiliation': 'Chair and Department of Computer Science and Statistics, Poznan University of Medical Sciences, 7 Rokietnicka Street, 60-806 Poznan, Poland.'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Bąbol', 'Affiliation': 'Lindsay & Gilmour Pharmacy, 5 Oliver Park, Hawick, Roxburghshire TD9 9BG, UK.'}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Szapel', 'Affiliation': 'Department of Physiotherapy, Poznan University of Medical Sciences, 11 Smoluchowskiego Street, 60-179 Poznan, Poland.'}, {'ForeName': 'Marzena', 'Initials': 'M', 'LastName': 'Bielas', 'Affiliation': 'Department of Family Medicine, Poznan University of Medical Sciences, 49 Przybyszewskiego Street, 60-355 Poznan, Poland.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Żabiński', 'Affiliation': 'Department of Organic Chemistry, Medical University of Warsaw, 1 Banacha Street, 02-097 Warsaw, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph19042071']
2364,35206215,"The Effects of Proprioceptive Training on Balance, Strength, Agility and Dribbling in Adolescent Male Soccer Players.","The aim of the study was to determine the effects of proprioceptive training (PT) on balance, strength, agility and dribbling in adolescent soccer players. In this research, we included an experimental ( n  = 48) and a control ( n  = 48) group (CG) with 14 years old players. The experimental group (EG) participated in an 8 week PT program, with four 30 min sessions per week. The experimental program included 12 bosu ball exercises to improve balance, stability and strength which were grouped into two subprograms: the first not using the soccer ball, the second subprogram using the soccer ball. The subprograms were implemented alternately during 16 proprioceptive training sessions, on two types of firm and foam surfaces. Pre- and post-tests included the static balance [Balance Error Scoring System (BESS)], vertical, horizontal, and lateral jumping, and the completion of agility (""arrowhead"") and dribbling (""short dribbling"") tests. Regarding the total BESS score, the CG has demonstrated progress between the pre- and the post-test, with 0.780 ± 0.895, fewer errors, while the EG had 5.828 ± 1.017 fewer errors. The difference between the two groups was of 5.148 fewer errors for the EG who had practiced the proposed program of proprioceptive training. The highest difference registered between the pre- and the post-test was at the test ""single-leg forward jump with the right leg"", with a result of 1.083 ± 0.459 cm for the CG and of 3.916 ± 0. 761 cm for the EG. Through the analysis of average differences between the pre- and the post-tests, we observe that, regarding the ""Agility right side test"", the EG has progressed with 0.382 s in comparison with the CG; regarding the ""Agility left side test"", the EG has progressed with 0.233 s compared to the CG; regarding the ""Agility right and left side test"", the EG has progressed with 0.196 s compared to the CG; in the ""Short dribbling test"", the EG has progressed with 0.174 s compared to the CG. The highest progress was made at the ""Agility right side test"", of 0.402 s for the EG, while the CG registered 0.120 s. Most of the results in all tests for both experimental groups show an effect size ranging from small to medium. The progress made by the experimental group in all tests was statistically significant, while in the control group the progress was mostly statistically insignificant for  p  < 0.05. The results suggest that a PT program performed at about 14 years of age could be successfully implemented in the training regime of soccer players to improve components of fitness along with dribbling skills. The results of the study revealed that sports training on the foam surfaces determined a superior progress of the development of proprioception compared to the increased training on the firm surfaces.",2022,"The highest difference registered between the pre- and the post-test was at the test ""single-leg forward jump with the right leg"", with a result of 1.083 ± 0.459 cm for the CG and of 3.916 ± 0.","['adolescent soccer players', 'experimental ( n  = 48) and a control ( n  = 48) group (CG) with 14 years old players', 'Adolescent Male Soccer Players']","['Proprioceptive Training', 'proprioceptive training (PT']","['total BESS score', 'static balance [Balance Error Scoring System (BESS)], vertical, horizontal, and lateral jumping, and the completion of agility (""arrowhead"") and dribbling (""short dribbling"") tests', 'balance, strength, agility and dribbling', 'Balance, Strength, Agility and Dribbling']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0453107', 'cui_str': 'Arrowhead'}, {'cui': 'C0013132', 'cui_str': 'Dribbling from mouth'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.00673553,"The highest difference registered between the pre- and the post-test was at the test ""single-leg forward jump with the right leg"", with a result of 1.083 ± 0.459 cm for the CG and of 3.916 ± 0.","[{'ForeName': 'Diana Victoria', 'Initials': 'DV', 'LastName': 'Gidu', 'Affiliation': 'Faculty of Physical Education and Sport, ""Ovidius"" University from Constanta, 900470 Constanta, Romania.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Badau', 'Affiliation': 'Petru Maior Faculty of Sciences and Letters, George Emil Palade University of Medicine, Pharmacy, Sciences and Technology, 540142 Targu Mures, Romania.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Stoica', 'Affiliation': 'Faculty of Physical Education and Sports, National University of Physical Education and Sports, 060057 Bucharest, Romania.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Aron', 'Affiliation': 'Department of Physical Therapy, Radford University, Roanoke, VA 24013, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Focan', 'Affiliation': '""Farul"" Academy Constanta, 900635 Constanta, Romania.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Monea', 'Affiliation': 'Faculty of Physical Education and Sports, Babes Bolyai University, 400048 Cluj-Napoca, Romania.'}, {'ForeName': 'Alina Mihaela', 'Initials': 'AM', 'LastName': 'Stoica', 'Affiliation': 'Department of Physical Education and Sport, University of Bucharest, 050107 Bucharest, Romania.'}, {'ForeName': 'Nicoleta Daniela', 'Initials': 'ND', 'LastName': 'Calota', 'Affiliation': 'Faculty of Physical Education and Sport, ""Ovidius"" University from Constanta, 900470 Constanta, Romania.'}]",International journal of environmental research and public health,['10.3390/ijerph19042028']
2365,35205175,"The Acute Effects of Normobaric Hypoxia on Strength, Muscular Endurance and Cognitive Function: Influence of Dose and Sex.","The aim of this study was to examine the acute effects of different levels of hypoxia on maximal strength, muscular endurance, and cognitive function in males and females. In total, 13 males (mean ± SD: age, 23.6 ± 2.8 years; height, 176.6 ± 3.9 cm; body mass, 76.6 ± 2.1 kg) and 13 females (mean ± SD: age, 22.8 ± 1.4 years; height, 166.4 ± 1.9 cm; body mass, 61.6 ± 3.4 kg) volunteered for a randomized, double-blind, crossover study. Participants completed a one repetition strength and muscular endurance test (60% of one repetition maximum to failure) for squat and bench press following four conditions; (i) normoxia (900 m altitude; F i O 2 : 21%); (ii) low dose hypoxia (2000 m altitude; F i O 2 : 16%); (iii) moderate dose hypoxia (3000 m altitude; F i O 2 : 14%); and (iv) high dose hypoxia (4000 m altitude; F i O 2 : 12%). Heart rate, blood lactate, rating of perceived exertion, and cognitive function was also determined during each condition. The one repetition maximum squat ( p  = 0.33) and bench press ( p  = 0.68) did not differ between conditions or sexes. Furthermore, squat endurance did not differ between conditions ( p  = 0.34). There was a significant decrease in bench press endurance following moderate ( p  = 0.02;  p  = 0.04) and high ( p  = 0.01;  p  = 0.01) doses of hypoxia in both males and females compared to normoxia and low dose hypoxia, respectively. Cognitive function, ratings of perceived exertion, and lactate were also significantly different in high and moderate dose hypoxia conditions compared to normoxia ( p  < 0.05). Heart rate was not different between the conditions ( p  = 0.30). In conclusion, high and moderate doses of acute normobaric hypoxia decrease upper body muscular endurance and cognitive performance regardless of sex; however, lower body muscular endurance and maximal strength are not altered.",2022,The one repetition maximum squat ( p  = 0.33) and bench press ( p  = 0.68) did not differ between conditions or sexes.,"['males and females', 'In total, 13 males (mean ± SD: age, 23.6 ± 2.8 years; height, 176.6 ± 3.9 cm; body mass, 76.6 ± 2.1 kg) and 13 females (mean ± SD: age, 22.8 ± 1.4 years; height, 166.4 ± 1.9 cm; body mass, 61.6 ± 3.4 kg) volunteered']",['Normobaric Hypoxia'],"['Cognitive function, ratings of perceived exertion, and lactate', 'Strength, Muscular Endurance and Cognitive Function', 'bench press endurance', 'Heart rate', 'maximal strength, muscular endurance, and cognitive function', 'squat endurance', 'body muscular endurance and maximal strength', 'repetition maximum squat', 'repetition strength and muscular endurance test', 'Heart rate, blood lactate, rating of perceived exertion, and cognitive function']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",13.0,0.0281995,The one repetition maximum squat ( p  = 0.33) and bench press ( p  = 0.68) did not differ between conditions or sexes.,"[{'ForeName': 'Raci', 'Initials': 'R', 'LastName': 'Karayigit', 'Affiliation': 'Faculty of Sport Sciences, Ankara University, Gölbaşı, Ankara 06830, Turkey.'}, {'ForeName': 'Mustafa Can', 'Initials': 'MC', 'LastName': 'Eser', 'Affiliation': 'Faculty of Sport Sciences, Ankara University, Gölbaşı, Ankara 06830, Turkey.'}, {'ForeName': 'Fatma Nese', 'Initials': 'FN', 'LastName': 'Sahin', 'Affiliation': 'Faculty of Sport Sciences, Ankara University, Gölbaşı, Ankara 06830, Turkey.'}, {'ForeName': 'Cengizhan', 'Initials': 'C', 'LastName': 'Sari', 'Affiliation': 'Faculty of Sport Sciences, Muş Alparslan University, Muş 49001, Turkey.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sanchez-Gomez', 'Affiliation': 'Department of Nursing Pharmacology and Physiotherapy, Faculty of Medicine and Nursing, University of Córdoba, 14000 Córdoba, Spain.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Dominguez', 'Affiliation': 'Departamento de Motricidad Humana y Rendimiento Deportivo, Universidad de Sevilla, 41013 Sevilla, Spain.'}, {'ForeName': 'Mitat', 'Initials': 'M', 'LastName': 'Koz', 'Affiliation': 'Physiotherapy and Rehabilitation Department, Faculty of Health Sciences, Eastern Mediterranean University, North Cyprus, Mersin, Famagusta 99628, Turkey.'}]",Biology,['10.3390/biology11020309']
2366,35205132,Effectiveness of Whole-Body Vibration Combined with Multicomponent Training on the Risk of Falls and Quality of Life in Elderly Women with Osteoporosis: Study Protocol for a Randomized Controlled Clinical Trial.,"Osteoporosis and the risk of falls increase the risk of fractures and events of falls. Prescriptions and programs for different forms of exercise have different impacts on the risk of falls, and exercises from multiple categories of whole-body vibration can be effective. This study aims to evaluate the effectiveness of whole-body vibration (WBV) protocol combined with multicomponent training (MCT) in elderly women with osteoporosis and their history of falls. Our proposal is a protocol for a randomized clinical trial, divided into two stages: First, development of a protocol for WVB combined with MCT for elderly women with osteoporosis and a history of falls, under the Guidelines of the American College of Sports Medicine, and following the recommendations of the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT), and second, a randomized controlled clinical trial following the Consolidated Standards of Reporting Trials (CONSORT). This trial will have implications for the effectiveness of a vibration protocol combined with multicomponent exercise on the risk of falls and quality of life for older women with osteoporosis. We expect that adding full-body vibration to an exercise protocol will decrease the risk of falls and improve participants' quality of life, as well as their strength, balance, and functional capacity.",2022,"We expect that adding full-body vibration to an exercise protocol will decrease the risk of falls and improve participants' quality of life, as well as their strength, balance, and functional capacity.","['older women with osteoporosis', 'elderly women with osteoporosis and their history of falls', 'Elderly Women with Osteoporosis', 'elderly women with osteoporosis and a history of falls, under the Guidelines of the American College of Sports Medicine']","['vibration protocol combined with multicomponent exercise', 'WVB combined with MCT', 'whole-body vibration (WBV) protocol combined with multicomponent training (MCT', 'Whole-Body Vibration Combined with Multicomponent Training']","[""risk of falls and improve participants' quality of life, as well as their strength, balance, and functional capacity"", 'risk of falls and quality of life', 'Risk of Falls and Quality of Life']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",,0.0466875,"We expect that adding full-body vibration to an exercise protocol will decrease the risk of falls and improve participants' quality of life, as well as their strength, balance, and functional capacity.","[{'ForeName': 'Rúbia Rayanne', 'Initials': 'RR', 'LastName': 'Souto Braz', 'Affiliation': 'Programa de Pós-Graduação em Fisioterapia, Departamento de Fisioterapia, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'Shirley Lima', 'Initials': 'SL', 'LastName': 'Campos', 'Affiliation': 'Programa de Pós-Graduação em Fisioterapia, Departamento de Fisioterapia, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'Débora Wanderley', 'Initials': 'DW', 'LastName': 'Villela', 'Affiliation': 'Programa de Pós-Graduação em Fisioterapia, Departamento de Fisioterapia, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'Gabriel Barreto', 'Initials': 'GB', 'LastName': 'Antonino', 'Affiliation': 'Programa de Pós-Graduação em Fisioterapia, Departamento de Fisioterapia, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'Pâmella Karolline', 'Initials': 'PK', 'LastName': 'Araújo Batista', 'Affiliation': 'Instituto de Medicina Integral Prof. Fernando Figueira, Recife, 50070-550, PE, Brazil.'}, {'ForeName': 'Marcelo Renato', 'Initials': 'MR', 'LastName': 'Guerino', 'Affiliation': 'Programa de Pós-Graduação em Saúde Translacional, Centro de Ciências Médicas, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'François Talles Medeiros', 'Initials': 'FTM', 'LastName': 'Rodrigues', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Instituto de Ciências Biológicas, Universidade de Pernambuco (UPE), Recife 50100-010, PE, Brazil.'}, {'ForeName': 'Kennedy Freitas', 'Initials': 'KF', 'LastName': 'Pereira Alves', 'Affiliation': 'Programa de Pós-Graduação em Fisioterapia, Departamento de Fisioterapia, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'João Victor Torres', 'Initials': 'JVT', 'LastName': 'Duarte', 'Affiliation': 'Departamento de Fisioterapia, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'de Andrade Silva', 'Affiliation': 'Departamento de Fisioterapia, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'Daniel Florentino', 'Initials': 'DF', 'LastName': 'Lima', 'Affiliation': 'Departamento de Fisioterapia, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'Arthur Felipe Freire', 'Initials': 'AFF', 'LastName': 'da Silva', 'Affiliation': 'Departamento de Fisioterapia, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'Karla Cybele Vieira', 'Initials': 'KCV', 'LastName': 'de Oliveira', 'Affiliation': 'Programa de Pós-Graduação em Fisioterapia, Departamento de Fisioterapia, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'Edy Kattarine Dias', 'Initials': 'EKD', 'LastName': 'Dos Santos', 'Affiliation': 'Programa de Pós-Graduação em Fisioterapia, Departamento de Fisioterapia, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'Wagner Souza', 'Initials': 'WS', 'LastName': 'Leite', 'Affiliation': 'Programa de Pós Graduação de Biologia Aplicada à Saúde, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'Larissa Coutinho', 'Initials': 'LC', 'LastName': 'de Lucena', 'Affiliation': 'UNIESP Centro Universitário, João Pessoa 58410-407, PB, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'de Lima Ferreira', 'Affiliation': 'Programa de Pós-Graduação em Fisioterapia, Departamento de Fisioterapia, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'Kátia', 'Initials': 'K', 'LastName': 'Monte-Silva', 'Affiliation': 'Programa de Pós-Graduação em Fisioterapia, Departamento de Fisioterapia, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'das Graças Rodrigues de Araújo', 'Affiliation': 'Programa de Pós-Graduação em Fisioterapia, Departamento de Fisioterapia, Universidade Federal de Pernambuco (UFPE), Recife 50670-901, PE, Brazil.'}, {'ForeName': 'Redha', 'Initials': 'R', 'LastName': 'Taiar', 'Affiliation': 'MATIM, Université de Reims Champagne-Ardenne, 51100 Reims, France.'}]",Biology,['10.3390/biology11020266']
2367,35205786,Quality of Life in the First Year of Follow-Up in a Randomized Multicenter Trial Assessing the Role of Imaging after Radical Surgery of Stage IIB-C and III Cutaneous Melanoma (TRIM Study).,"The benefit of imaging in the follow-up setting for high-risk melanoma patients is uncertain, and even less is known about the impact of intensive follow-up on the patient´s quality of life. In 2017, a Swedish prospective randomized multicenter study started, in which high-risk melanoma patients are randomly assigned 1:1 to follow-up by physical examinations +/- whole-body imaging. The first-year examinations are scheduled at 0, 6 and 12 months. The aim of this study was to investigate whether the patients´ health-related quality of life (HRQoL) and levels of anxiety and depression were affected at 1 year by imaging. Anxiety/depression and HRQoL were assessed at 0 and 12 months by the questionnaires Hospital Anxiety and Depression (HAD) scale and EORTC QLQ-C30 version 3. Expected baseline QLQ-C30 values for the patients were calculated using data from the general population. In total, 204 patients were analyzed. Mean differences in subscale scores at 1 year were not statistically significant either for HRQoL or for anxiety/depression. Baseline HRQoL did not differ from expected values in the general Swedish population. In conclusion, the patients in general coped well with the situation, and adding whole-body imaging to physical examinations did not affect the melanoma patients' HRQoL or levels of anxiety or depression.",2022,Mean differences in subscale scores at 1 year were not statistically significant either for HRQoL or for anxiety/depression.,"['high-risk melanoma patients', '204 patients were analyzed']",['physical examinations '],"['baseline QLQ-C30 values', 'questionnaires Hospital Anxiety and Depression (HAD) scale and EORTC QLQ-C30 version 3', 'Quality of Life', ""melanoma patients' HRQoL or levels of anxiety or depression"", 'Baseline HRQoL', 'subscale scores', 'patients´ health-related quality of life (HRQoL) and levels of anxiety and depression', 'Anxiety/depression and HRQoL']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",204.0,0.0556984,Mean differences in subscale scores at 1 year were not statistically significant either for HRQoL or for anxiety/depression.,"[{'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Naeser', 'Affiliation': 'Rudbeck Laboratory, Department of Immunology, Genetics and Pathology, Uppsala University, 751 85 Uppsala, Sweden.'}, {'ForeName': 'Hildur', 'Initials': 'H', 'LastName': 'Helgadottir', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Hansson', 'Affiliation': 'Theme Cancer, Karolinska University Hospital, 171 76 Stockholm, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ingvar', 'Affiliation': 'Department of Surgery, Clinical Sciences, Lund University, BMC F12, 221 84 Lund, Sweden.'}, {'ForeName': 'Nils O', 'Initials': 'NO', 'LastName': 'Elander', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Linköping University, 581 85 Linköping, Sweden.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Flygare', 'Affiliation': 'Department of Oncology, Sundsvall County Hospital, Lasarettsgatan 21, 856 43 Sundsvall, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Nilsson', 'Affiliation': 'Department of Oncology, Hospital of Västmanland Västerås, 721 89 Västerås, Sweden.'}, {'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Jakobsson', 'Affiliation': 'Department of Oncology, Örebro University Hospital, 701 85 Örebro, Sweden.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Valachis', 'Affiliation': 'Department of Oncology, Faculty of Medicine and Health, Örebro University, 701 82 Örebro, Sweden.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Papantoniou', 'Affiliation': 'Department of Oncology, Ryhov County Hospital, 551 85 Jönköping, Sweden.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Nordin Danfors', 'Affiliation': 'Department of Oncology, Visby County Hospital, St. Göransgatan 5, 621 84 Visby, Sweden.'}, {'ForeName': 'Hemming', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Sundin', 'Affiliation': 'Department of Surgical Sciences Radiology & Molecular Imaging, Uppsala University, 751 85 Uppsala, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Brandberg', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Gustav J', 'Initials': 'GJ', 'LastName': 'Ullenhag', 'Affiliation': 'Rudbeck Laboratory, Department of Immunology, Genetics and Pathology, Uppsala University, 751 85 Uppsala, Sweden.'}]",Cancers,['10.3390/cancers14041040']
2368,35205698,Impact of Open Dialogue about Complementary Alternative Medicine-A Phase II Randomized Controlled Trial.,"Complementary alternative medicine (CAM) may reduce the symptom burden of side effects to antineoplastic treatment but also cause new side effects and non-adherence to conventional treatment. The aim of this RCT was to investigate the impact of open dialogue about complementary alternative medicine (OD-CAM) on cancer patients' safety, health and quality of life (QoL). Patients undergoing antineoplastic treatment were randomly assigned to standard care (SC) plus OD-CAM or SC alone. The primary endpoint was frequency of grade 3-4 adverse events (AE) eight weeks after enrollment. Secondary endpoints were frequency of grade 1-4 AE, QoL, psychological distress, perceived information, attitude towards and use of CAM 12 and 24 weeks after enrollment. Survival was analyzed post hoc. Fifty-seven patients were randomized to the OD-CAM group and fifty-five to the SC group. No significant difference in frequency of grade 3-4 AEs was shown. The same applied to grade 1-4 AEs and QoL, psychological distress and perceived information. A tendency towards better QoL, improved survival and a lower level of anxiety was found in the OD-CAM group. OD-CAM is not superior to SC in reducing the frequency of AEs in patients undergoing antineoplastic treatment. OD-CAM does not compromise patient safety; it may reduce psychological stress and improve QoL and overall survival.",2022,No significant difference in frequency of grade 3-4 AEs was shown.,"['patients undergoing antineoplastic treatment', 'Fifty-seven patients', 'Patients undergoing antineoplastic treatment', 'cancer patients']","['standard care (SC) plus OD-CAM or SC alone', 'OD-CAM', 'Complementary alternative medicine (CAM', 'open dialogue about complementary alternative medicine (OD-CAM']","['frequency of grade 1-4 AE, QoL, psychological distress, perceived information, attitude towards and use of CAM', 'survival and a lower level of anxiety', 'safety, health and quality of life (QoL', 'Survival', 'psychological stress and improve QoL and overall survival', 'frequency of grade 3-4 adverse events (AE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",57.0,0.0807392,No significant difference in frequency of grade 3-4 AEs was shown.,"[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Stie', 'Affiliation': 'Department of Oncology, University Hospital of Southern Denmark, 7100 Vejle, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Delmar', 'Affiliation': 'Department of Public Health, Research Unit for Nursing and Health Care, Aarhus University, 8000 Aarhus, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Nørgaard', 'Affiliation': 'Department of Public Health, University of Southern Denmark, 5000 Odense, Denmark.'}, {'ForeName': 'Lars Henrik', 'Initials': 'LH', 'LastName': 'Jensen', 'Affiliation': 'Department of Oncology, University Hospital of Southern Denmark, 7100 Vejle, Denmark.'}]",Cancers,['10.3390/cancers14040952']
2369,35205644,Time-Dependent Efficacy of Checkpoint Inhibitor Nivolumab: Results from a Pilot Study in Patients with Metastatic Non-Small-Cell Lung Cancer.,"HYPOTHESIS


Prior experimental and human studies have demonstrated the circadian organization of immune cells' proliferation, trafficking, and antigen recognition and destruction. Nivolumab targets T(CD8) cells, the functions, and trafficking of which are regulated by circadian clocks, hence suggesting possible daily changes in nivolumab's efficacy. Worse progression-free survival (PFS), and overall survival (OS) were reported for malignant melanoma patients receiving more than 20% of their immune checkpoint inhibitor infusions after 16:30 as compared to earlier in the day.
METHODS


Consecutive metastatic non-small-cell cancer (NSCLC) patients received nivolumab (240 mg iv q 2 weeks) at a daily time that was 'randomly' allocated for each course on a logistical basis by the day-hospital coordinators. The median time of all nivolumab administrations was computed for each patient. The study population was split into two timing groups based upon the median value of the median treatment times of all patients. CTCAE-toxicity rates, iRECIST-tumor responses, PFS and OS were computed according to nivolumab timing. PFS and OS curves were compared and hazard ratios (HR) were computed for all major categories of characteristics. Multivariable and sensitivity analyses were also performed.
RESULTS


The study accrued 95 stage-IV NSCLC patients (PS 0-1, 96%), aged 41-83 years. The majority of nivolumab administrations occurred between 9:27 and 12:54 for 48 patients ('morning' group) and between 12:55 and 17:14 for the other 47 ('afternoon' group). Median PFS (95% CL) was 11.3 months (5.5-17.1) for the 'morning' group and 3.1 months (1.5-4.6) for the 'afternoon' one ( p  < 0.001). Median OS was 34.2 months (15.1-53.3) and 9.6 months (4.9-14.4) for the 'morning' group and the 'afternoon' one, respectively ( p  < 0.001). Multivariable analyses identified 'morning' timing as a significant predictor of longer PFS and OS, with respective HR values of 0.26 (0.11-0.58) and 0.17 (0.08-0.37). The timing effect was consistent across all patient subgroups tested.
CONCLUSIONS


Nivolumab was nearly four times as effective following 'morning' as compared to 'afternoon' dosing in this cohort of NSCLC patients. Prospective timing-studies are needed to minimize the risk of resistance and to maximize the benefits from immune checkpoint inhibitors.",2022,Median PFS (95% CL) was 11.3 months (5.5-17.1) for the 'morning' group and 3.1 months (1.5-4.6) for the 'afternoon' one ( p  < 0.001).,"['Patients with Metastatic Non-Small-Cell Lung Cancer', 'Consecutive metastatic non-small-cell cancer (NSCLC) patients received', '95 stage-IV NSCLC patients (PS 0-1, 96%), aged 41-83 years']","['Checkpoint Inhibitor Nivolumab', 'nivolumab']","['PFS and OS curves', 'CTCAE-toxicity rates, iRECIST-tumor responses, PFS and OS', 'Worse progression-free survival (PFS), and overall survival (OS', 'Median PFS', 'Median OS', 'median time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0445128', 'cui_str': 'Non-small cell'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.185946,Median PFS (95% CL) was 11.3 months (5.5-17.1) for the 'morning' group and 3.1 months (1.5-4.6) for the 'afternoon' one ( p  < 0.001).,"[{'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Karaboué', 'Affiliation': 'Medical Oncology Unit, GHT Paris Grand Nord-Est, Le Raincy-Montfermeil, 93770 Montfermeil, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Collon', 'Affiliation': 'Medical Oncology Unit, GHT Paris Grand Nord-Est, Le Raincy-Montfermeil, 93770 Montfermeil, France.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Pavese', 'Affiliation': 'Medical Oncology Unit, GHT Paris Grand Nord-Est, Le Raincy-Montfermeil, 93770 Montfermeil, France.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Bodiguel', 'Affiliation': 'Pathology Unit, GHT Paris Grand Nord-Est, Le Raincy-Montfermeil, 93370 Montfermeil, France.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Cucherousset', 'Affiliation': 'Pathology Unit, GHT Paris Grand Nord-Est, Le Raincy-Montfermeil, 93370 Montfermeil, France.'}, {'ForeName': 'Elda', 'Initials': 'E', 'LastName': 'Zakine', 'Affiliation': 'Pathology Unit, GHT Paris Grand Nord-Est, Le Raincy-Montfermeil, 93370 Montfermeil, France.'}, {'ForeName': 'Pasquale F', 'Initials': 'PF', 'LastName': 'Innominato', 'Affiliation': 'UPR ""Chronotherapy, Cancer and Transplantation"", Medical School, Paris-Saclay University, 94800 Villejuif, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bouchahda', 'Affiliation': 'UPR ""Chronotherapy, Cancer and Transplantation"", Medical School, Paris-Saclay University, 94800 Villejuif, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Adam', 'Affiliation': 'UPR ""Chronotherapy, Cancer and Transplantation"", Medical School, Paris-Saclay University, 94800 Villejuif, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Lévi', 'Affiliation': 'UPR ""Chronotherapy, Cancer and Transplantation"", Medical School, Paris-Saclay University, 94800 Villejuif, France.'}]",Cancers,['10.3390/cancers14040896']
2370,35206123,"Reducing Obesogenic Eating Behaviors in Hispanic Children through a Family-Based, Culturally-Tailored RCT:  Abriendo Caminos .","Family-based interventions that incorporate culturally-tailored multi-component curricula and are grounded on evidence-based information and theoretical frameworks can help reduce the prevalence of obesity among Hispanic children.  Abriendo Caminos : Clearing the Path to Hispanic Health is a multi-site culturally-tailored randomized control trial that aims to reduce obesity rates in Hispanic families by delivering education on nutrition, family wellness, and physical activity. This study evaluated the effect of the  Abriendo Caminos  six-week intervention on dietary behaviors of Hispanic children (6-18 years). Mothers ( n  = 365) reported their child's eating behavior intake using the U.S. Department of Education's Early Childhood Longitudinal Study protocol (ECLS). Pre/post dietary changes were evaluated using separate generalized estimating equation models adjusted for site, child sex, and child age group. Findings indicate a reduction in the frequency of sugar-sweetened beverages (OR 0.55, 95% CI 0.35, 0.87,  p  = 0.01), French fries (OR 0.56, 95% CI 0.36, 0.86,  p  = 0.009), and fast food (OR 0.55, 95% CI 0.36, 0.84,  p  = 0.006) consumption among children in the intervention arm. Additionally, children in the intervention arm increased their frequency of vegetable consumption (OR 1.84, 95% CI 1.08, 3.12,  p  = 0.03). The  Abriendo Caminos  intervention effectively improved four of eight eating behaviors in a short-term intervention.",2022,"Additionally, children in the intervention arm increased their frequency of vegetable consumption (OR 1.84, 95% CI 1.08, 3.12,  p  = 0.03).","['Hispanic Children', 'Hispanic children (6-18 years', 'children in the intervention arm', ""Mothers ( n  = 365) reported their child's eating behavior intake using the U.S. Department of Education's Early Childhood Longitudinal Study protocol (ECLS"", 'Hispanic children', 'Hispanic families']",['Abriendo Caminos  six-week intervention'],"['frequency of vegetable consumption', 'Obesogenic Eating Behaviors', 'French fries', 'eating behaviors', 'frequency of sugar-sweetened beverages', 'dietary behaviors']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0265052,"Additionally, children in the intervention arm increased their frequency of vegetable consumption (OR 1.84, 95% CI 1.08, 3.12,  p  = 0.03).","[{'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Barragan', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL 61801, USA.'}, {'ForeName': 'Viridiana', 'Initials': 'V', 'LastName': 'Luna', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL 61801, USA.'}, {'ForeName': 'Amber J', 'Initials': 'AJ', 'LastName': 'Hammons', 'Affiliation': 'Department of Child and Family Science, California State University, Fresno, CA 93740, USA.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Olvera', 'Affiliation': 'Department of Psychological, Health, and Learning Sciences, University of Houston, Houston, TX 77204, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Greder', 'Affiliation': 'Department of Human Development and Family Studies, Iowa State University, Ames, IA 50011, USA.'}, {'ForeName': 'Flavia Cristina', 'Initials': 'FC', 'LastName': 'Drumond Andrade', 'Affiliation': 'School of Social Work, University of Illinois at Urbana-Champaign, Urbana, IL 61801, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Fiese', 'Affiliation': 'Department of Human Development and Family Studies, Family Resiliency Center, University of Illinois at Urbana-Champaign, Urbana, IL 61801, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wiley', 'Affiliation': 'Department of Human Development and Family Science, Auburn University, Auburn, AL 36849, USA.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Teran-Garcia', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL 61801, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'The Abriendo Caminos Research Team', 'Affiliation': ''}]",International journal of environmental research and public health,['10.3390/ijerph19041917']
2371,35206550,Effectiveness of a Parent Training Programme for Parents of Adolescents with Autism Spectrum Disorders: Aiming to Improve Daily Living Skills.,"Parent training (PT) has been well established in younger children with autism spectrum disorder (ASD) but is less well studied in adolescents. This study examined the effects of attempting PT to enhance the daily living skills (DLSs) of adolescents with ASD. Twenty-five parents of adolescents with ASD participated in either the immediate- or delayed-treatment control condition. Children's DLSs were evaluated using the DLS domain of the Vineland Adaptive Behaviour Scales-II, and the achievement of the DLSs practised by the children at home was the subject of the evaluation. The DLS domain score showed no improvement in the treatment group compared to the control group. However, some parents in the treatment group reported that their children acquired the target DLSs and more sophisticated communication behaviours. In addition, one measure suggested that parents increased their praising behaviours. These changes may have been driven by the completion of the parent training. We discuss several aspects of developing parent-mediated interventions based on the current intervention situation and observed changes.",2022,The DLS domain score showed no improvement in the treatment group compared to the control group.,"['Parents of Adolescents with Autism Spectrum Disorders', 'Twenty-five parents of adolescents with ASD participated in either the immediate- or delayed-treatment control condition', 'younger children with autism spectrum disorder (ASD', 'adolescents with ASD']","['Parent training (PT', 'Parent Training Programme']","['DLS domain score', 'daily living skills (DLSs', 'praising behaviours']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C3693346', 'cui_str': 'Treatment Delay'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0557963', 'cui_str': 'Praising'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",25.0,0.0135468,The DLS domain score showed no improvement in the treatment group compared to the control group.,"[{'ForeName': 'Nanako', 'Initials': 'N', 'LastName': 'Matsumura', 'Affiliation': 'Department of Child Development, United Graduate School of Child Development, Osaka University, Suita 565-0871, Osaka, Japan.'}, {'ForeName': 'Haruo', 'Initials': 'H', 'LastName': 'Fujino', 'Affiliation': 'Department of Child Development, United Graduate School of Child Development, Osaka University, Suita 565-0871, Osaka, Japan.'}, {'ForeName': 'Tomoka', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': ""Molecular Research Centre for Children's Mental Development, United Graduate School of Child Development, Osaka University, Suita 565-0871, Osaka, Japan.""}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Tanida', 'Affiliation': 'Japan Society for the Promotion of Science, Tokyo 102-0083, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Ishii', 'Affiliation': ""Molecular Research Centre for Children's Mental Development, United Graduate School of Child Development, Osaka University, Suita 565-0871, Osaka, Japan.""}, {'ForeName': 'Aika', 'Initials': 'A', 'LastName': 'Tatsumi', 'Affiliation': ""Molecular Research Centre for Children's Mental Development, United Graduate School of Child Development, Osaka University, Suita 565-0871, Osaka, Japan.""}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Nakanishi', 'Affiliation': ""Molecular Research Centre for Children's Mental Development, United Graduate School of Child Development, Osaka University, Suita 565-0871, Osaka, Japan.""}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Tachibana', 'Affiliation': ""Molecular Research Centre for Children's Mental Development, United Graduate School of Child Development, Osaka University, Suita 565-0871, Osaka, Japan.""}, {'ForeName': 'Ikuko', 'Initials': 'I', 'LastName': 'Mohri', 'Affiliation': 'Department of Child Development, United Graduate School of Child Development, Osaka University, Suita 565-0871, Osaka, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Okuno', 'Affiliation': 'Graduate School of Nursing of Health and Human Science, Osaka Prefecture University, Habikino 583-8555, Osaka, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph19042363']
2372,35206521,The We Can Quit2 Smoking Cessation Trial: Knowledge Exchange and Dissemination Following a Community-Based Participatory Research Approach.,"BACKGROUND


'We Can Quit2' pilot randomised controlled trial determined the feasibility [of conducting a community-based trial of We Can Quit, a peer-delivered stop-smoking programme (group support, combination nicotine replacement therapy (NRT), and tailored individual support) for women living in socioeconomically disadvantaged areas in Ireland. Lessons from a knowledge exchange (KE) workshop that reengaged trial stakeholders are presented.
METHODS


The trial dissemination plan included invitation of community, regional and national stakeholders ( n  = 176) to a KE interactive workshop, who received an accessible brief beforehand. Trial findings were presented. Enhancements to community engagement, participants' recruitment and retention, and policy priorities arising from the research were discussed. Field notes and responses to a post-event anonymous questionnaire were analysed using thematic content analysis.
RESULTS


Workshop attendees (41/176, 23%) recommended: dedicated additional time to engage community stakeholders; social prescribing pathways to enhance recruitment; more adaptation of trial-related information and assistance in completion of data forms for low literacy individuals; encouraging women to join healthy community programmes to facilitate retention and sustainability; removal of barriers to access NRT; and ongoing provision of cessation services tailored to disadvantaged groups.
CONCLUSIONS


The findings are relevant to the implementation of other community-based health interventions for disadvantaged groups, to policy makers and to service providers.",2022,"RESULTS


Workshop attendees (41/176, 23%) recommended: dedicated additional time to engage community stakeholders; social prescribing pathways to enhance recruitment; more adaptation of trial-related information and assistance in completion of data forms for low literacy individuals; encouraging women to join healthy community programmes to facilitate retention and sustainability; removal of barriers to access NRT; and ongoing provision of cessation services tailored to disadvantaged groups.
",['women living in socioeconomically disadvantaged areas in Ireland'],"['KE interactive workshop', 'nicotine replacement therapy (NRT), and tailored individual support']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",[],,0.0838026,"RESULTS


Workshop attendees (41/176, 23%) recommended: dedicated additional time to engage community stakeholders; social prescribing pathways to enhance recruitment; more adaptation of trial-related information and assistance in completion of data forms for low literacy individuals; encouraging women to join healthy community programmes to facilitate retention and sustainability; removal of barriers to access NRT; and ongoing provision of cessation services tailored to disadvantaged groups.
","[{'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Castello', 'Affiliation': 'Public Health & Primary Care, Institute of Population Health, Trinity College Dublin, D24DH74 Dublin, Ireland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Darker', 'Affiliation': 'Public Health & Primary Care, Institute of Population Health, Trinity College Dublin, D24DH74 Dublin, Ireland.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Vance', 'Affiliation': 'Community Programmes, Irish Cancer Society, D04VX65 Dublin, Ireland.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Dougall', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University, Edinburgh EH11 4BN, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bauld', 'Affiliation': 'Usher Institute and SPECTRUM Consortium, College of Medicine and Veterinary Science, University of Edinburgh, Edinburgh EH16 4TJ, UK.'}, {'ForeName': 'Catherine B', 'Initials': 'CB', 'LastName': 'Hayes', 'Affiliation': 'Public Health & Primary Care, Institute of Population Health, Trinity College Dublin, D24DH74 Dublin, Ireland.'}]",International journal of environmental research and public health,['10.3390/ijerph19042333']
2373,35207351,Feasibility of a Multimodal Telemedical Intervention for Patients with Parkinson's Disease-A Pilot Study.,"Symptoms of Parkinson's disease (PD) can be controlled well, but treatment often requires expert judgment. Telemedicine and sensor-based assessments can allow physicians to better observe the evolvement of symptoms over time, in particular with motor fluctuations. In addition, they potentially allow less frequent visits to the expert's office and facilitate care in rural areas. A variety of systems with different strengths and shortcomings has been investigated in recent years. We designed a multimodal telehealth intervention (TelePark) to mitigate the shortcomings of individual systems and assessed the feasibility of our approach in 12 patients with PD over 12 weeks in preparation for a larger randomized controlled trial. TelePark uses video visits, a smartphone app, a camera system, and wearable sensors. Structured training included setting up the equipment in patients' homes and group-based online training. Usability was assessed by questionnaires and semi-standardized telephone interviews. Overall, 11 out of 12 patients completed the trial (5 female, 6 male). Mean age was 65 years, mean disease duration 7 years, mean MoCA score 27. Adherence was stable throughout the study and 79% for a short questionnaire administered every second day, 62% for medication confirmation, and 33% for an electronic Hauser diary. Quality of life did not change in the course of the study, and a larger cohort will be required to determine the effect on motor symptoms. Interviews with trial participants identified motivations to use such systems and areas for improvements. These insights can be helpful in designing similar trials.",2022,"Adherence was stable throughout the study and 79% for a short questionnaire administered every second day, 62% for medication confirmation, and 33% for an electronic Hauser diary.","['Mean age was 65 years, mean disease duration 7 years, mean MoCA score 27', '12 patients completed the trial (5 female, 6 male', ""Symptoms of Parkinson's disease (PD"", ""Patients with Parkinson's Disease-A Pilot Study"", '12 patients with PD over 12 weeks in preparation']","['multimodal telehealth intervention (TelePark', ""Structured training included setting up the equipment in patients' homes and group-based online training"", 'Telemedicine and sensor-based assessments', 'Multimodal Telemedical Intervention']","['Adherence', 'Usability', 'Quality of life']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",12.0,0.0526624,"Adherence was stable throughout the study and 79% for a short questionnaire administered every second day, 62% for medication confirmation, and 33% for an electronic Hauser diary.","[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Bendig', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Anna-Sophie', 'Initials': 'AS', 'LastName': 'Wolf', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mark', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Frank', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Mathiebe', 'Affiliation': 'Center for Evidence-Based Healthcare, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Madlen', 'Initials': 'M', 'LastName': 'Scheibe', 'Affiliation': 'Center for Evidence-Based Healthcare, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Müller', 'Affiliation': 'Center for Evidence-Based Healthcare, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Stahr', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schmitt', 'Affiliation': 'Center for Evidence-Based Healthcare, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Reichmann', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Kai F', 'Initials': 'KF', 'LastName': 'Loewenbrück', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Björn H', 'Initials': 'BH', 'LastName': 'Falkenburger', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, 01307 Dresden, Germany.'}]",Journal of clinical medicine,['10.3390/jcm11041074']
2374,35207341,Upper Body Physical Rehabilitation for Children with Ataxia through IMU-Based Exergame.,"BACKGROUND


Children with ataxia experience balance and movement coordination difficulties and needs intensive physical intervention to maintain functional abilities and counteract the disorder. Exergaming represents a valuable strategy to provide engaging physical intervention to children with ataxia, sustaining their motivation to perform the intervention. This paper aims to describe the effect of a home-conducted exergame-based exercise training for upper body movements control of children with ataxia on their ataxic symptoms, walking ability, and hand dexterity.
METHODS


Eighteen children with ataxia were randomly divided into intervention and control groups. Participants in the intervention group were asked to follow a 12-week motor activity program at home using the Niurion ®  exergame. Blind assessments of participants' ataxic symptoms, dominant and non-dominant hand dexterity, and walking ability were conducted.
RESULTS


On average, the participants performed the intervention for 61.5% of the expected time. At the end of the training, participants in the intervention group showed improved hand dexterity that worsened in the control group.
CONCLUSION


The presented exergame enhanced the participants' hand dexterity. However, there is a need for exergames capable of maintaining a high level of players' motivation in playing. It is advisable to plan a mixed intervention to take care of the multiple aspects of the disorder.",2022,"At the end of the training, participants in the intervention group showed improved hand dexterity that worsened in the control group.
","['Children with Ataxia through IMU-Based Exergame', 'Eighteen children with ataxia', 'children with ataxia on their ataxic symptoms, walking ability, and hand dexterity', ""participants' ataxic symptoms, dominant and non-dominant hand dexterity, and walking ability were conducted""]","['home-conducted exergame-based exercise training', 'motor activity program at home using the Niurion ®  exergame', 'Upper Body Physical Rehabilitation', 'intensive physical intervention']",['hand dexterity'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0270602', 'cui_str': 'Latah'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0234366', 'cui_str': 'Ataxic'}, {'cui': 'C0449722', 'cui_str': 'Dominant hand'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}]",18.0,0.00804062,"At the end of the training, participants in the intervention group showed improved hand dexterity that worsened in the control group.
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Romano', 'Affiliation': 'Movement Analysis and Robotics Laboratory (MAR Lab), Intensive Neurorehabilitation and Robotics Department, ""Bambino Gesù"" Children\'s Hospital, IRCCS, 00050 Rome, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Favetta', 'Affiliation': 'Movement Analysis and Robotics Laboratory (MAR Lab), Intensive Neurorehabilitation and Robotics Department, ""Bambino Gesù"" Children\'s Hospital, IRCCS, 00050 Rome, Italy.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Summa', 'Affiliation': 'Movement Analysis and Robotics Laboratory (MAR Lab), Intensive Neurorehabilitation and Robotics Department, ""Bambino Gesù"" Children\'s Hospital, IRCCS, 00050 Rome, Italy.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Schirinzi', 'Affiliation': 'Department of Systems Medicine, University of Rome ""Tor Vergata"", 00133 Rome, Italy.'}, {'ForeName': 'Enrico Silvio', 'Initials': 'ES', 'LastName': 'Bertini', 'Affiliation': 'Unit of Neuromuscolar and Neurodegenerative Diseases, Department of Neurosciences, ""Bambino Gesù"" Children\'s Hospital, IRCCS, 00146 Rome, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Castelli', 'Affiliation': 'Movement Analysis and Robotics Laboratory (MAR Lab), Intensive Neurorehabilitation and Robotics Department, ""Bambino Gesù"" Children\'s Hospital, IRCCS, 00050 Rome, Italy.'}, {'ForeName': 'Gessica', 'Initials': 'G', 'LastName': 'Vasco', 'Affiliation': 'Movement Analysis and Robotics Laboratory (MAR Lab), Intensive Neurorehabilitation and Robotics Department, ""Bambino Gesù"" Children\'s Hospital, IRCCS, 00050 Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Petrarca', 'Affiliation': 'Movement Analysis and Robotics Laboratory (MAR Lab), Intensive Neurorehabilitation and Robotics Department, ""Bambino Gesù"" Children\'s Hospital, IRCCS, 00050 Rome, Italy.'}]",Journal of clinical medicine,['10.3390/jcm11041065']
2375,35207790,Effects of Pain Neuroscience Education Combined with Lumbar Stabilization Exercise on Strength and Pain in Patients with Chronic Low Back Pain: Randomized Controlled Trial.,"Chronic low back pain that lasts more than 12 weeks causes mental and physical distress. This study investigated the effects of pain neuroscience education combined with lumbar stabilization exercises on strength, pain, flexibility, and activity disorder index in female patients with chronic low back pain. Thirty-five female patients with chronic low back pain were randomly divided into two groups: the pain neuroscience education (PNE) combined with lumbar stabilization exercises (LSEs) group ( n  = 18, experimental group) and the lumbar stabilization exercises alone group ( n  = 17, control group). The experimental group underwent PNE combined with LSEs for 30 min per session, twice per week for 8 weeks, and the control group underwent LSEs only. The primary outcomes were strength (sit-up and back-up movements), Numerical Pain Rating Scale (NPRS), Korean Pain Catastrophizing Scale (K-PCS), and Tampa Scale of Kinesio-phobia-11 (TSK-11) for pain. The secondary outcomes were modified-modified Schober's test (MMST) and finger to floor test (FFT) for flexibility and activity disorder (Roland-Morris Disability Questionnaire index). A significant difference was observed in the primary outcomes after intervention in the abdominal muscle strength (group difference, mean, -7.50; 95% CI, -9.111 to -5.889, F = 9.598; ANCOVA  p  = 0.005), the back muscle strength (group difference, mean, -9.722; 95% CI, -10.877 to -8.568, F = 7.102; ANCOVA  p  = 0.014), the NPRS (group difference, mean, 1.89; 95% CI,1.65 to 2.12, F = 24.286; ANCOVA  p  < 0.001), K-PCS (group difference, mean, 7.89; 95% CI, 7.02 to 8.76, F = 11.558; ANCOVA  p  = 0.003), and TSK-11 (group difference, mean, 16.79; 95% CI, 13.99 to 19.59, F = 13.179; ANCOVA  p  = 0.014) for pain. In the secondary outcomes, there was a significant difference in the FFT (group difference, mean, -0.66; 95%CI, -0.99 to -0.33, F = 4.327; ANCOVA  p  = 0.049), whereas the difference in flexibility (MMST) and activity disorder index of the secondary outcomes did not reach significance. Therefore, this study confirmed that PNE combined with LSEs is an effective intervention compared to LSE alone in improving muscle strength and pain in female patients with chronic low back pain.",2022,"In the secondary outcomes, there was a significant difference in the FFT (group difference, mean, -0.66; 95%CI, -0.99 to -0.33, F = 4.327; ANCOVA  p  = 0.049), whereas the difference in flexibility (MMST) and activity disorder index of the secondary outcomes did not reach significance.","['Patients with Chronic Low Back Pain', 'group ( n  ', 'Thirty-five female patients with chronic low back pain', 'female patients with chronic low back pain']","['pain neuroscience education combined with lumbar stabilization exercises', 'FFT', 'Pain Neuroscience Education Combined with Lumbar Stabilization Exercise', 'lumbar stabilization exercises alone', 'LSE alone', 'PNE combined with LSEs', 'pain neuroscience education (PNE) combined with lumbar stabilization exercises (LSEs']","['flexibility (MMST) and activity disorder index', 'pain', 'strength, pain, flexibility, and activity disorder index', 'Chronic low back pain', 'strength (sit-up and back-up movements), Numerical Pain Rating Scale (NPRS), Korean Pain Catastrophizing Scale (K-PCS), and Tampa Scale of Kinesio-phobia-11 (TSK-11) for pain', 'abdominal muscle strength', 'back muscle strength', 'Strength and Pain', 'muscle strength and pain', ""modified-modified Schober's test (MMST) and finger to floor test (FFT) for flexibility and activity disorder (Roland-Morris Disability Questionnaire index""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0560837', 'cui_str': 'Does sit up'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0000739', 'cui_str': 'Skeletal muscle structure of abdomen'}, {'cui': 'C0224334', 'cui_str': 'Skeletal muscle structure of back'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430750', 'cui_str': 'Modified Schober test'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",35.0,0.0832752,"In the secondary outcomes, there was a significant difference in the FFT (group difference, mean, -0.66; 95%CI, -0.99 to -0.33, F = 4.327; ANCOVA  p  = 0.049), whereas the difference in flexibility (MMST) and activity disorder index of the secondary outcomes did not reach significance.","[{'ForeName': 'Ki-Sang', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Graduate School of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}, {'ForeName': 'Jungae', 'Initials': 'J', 'LastName': 'An', 'Affiliation': 'Graduate School of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}, {'ForeName': 'Ju-O', 'Initials': 'JO', 'LastName': 'Kim', 'Affiliation': 'Graduate School of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}, {'ForeName': 'Mi-Young', 'Initials': 'MY', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}, {'ForeName': 'Byoung-Hee', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}]",Journal of personalized medicine,['10.3390/jpm12020303']
2376,35207706,Effectiveness of Virtual Reality-Based Training on Oral Healthcare for Disabled Elderly Persons: A Randomized Controlled Trial.,"(1) Background: Virtual reality (VR) technology is a widely used training tool in medical education. The present study aimed to evaluate the effectiveness of VR training of oral hygiene students on providing oral healthcare to disabled elderly persons. (2) Methods: A randomized controlled trial was conducted. In 2021, oral hygiene students were randomly assigned to a VR experimental group (EG;  n  = 11) and a control group (CG;  n  = 12). The EG received two-hour, thrice-repeated VR-based training interventions at 2-week, 4-week, and 6-week follow-ups. The CG received no VR-based interventions. Data were collected using a self-administered questionnaire before and immediately after each intervention. We performed generalized estimating equations to compare the responses. (3) Results: The EG exhibited a more significant improvement in oral care-related knowledge, attitude, self-efficacy, and intention at the 6-week follow-up than the CG. The students' intention to assist the elderly in using interdental brushes (β = 0.91), with soft tissue cleaning (β = 0.53), and with oral desensitization (β = 0.53), and to have regular dental visits (β = 0.61) improved significantly at the 6-week follow-up. (4) Conclusions: VR training positively affected students' knowledge, attitude, self-efficacy, and intentions on providing oral healthcare to disabled elderly persons.",2022,"VR training positively affected students' knowledge, attitude, self-efficacy, and intentions on providing oral healthcare to disabled elderly persons.","['disabled elderly persons', 'In 2021, oral hygiene students', 'oral hygiene students on providing oral healthcare to disabled elderly persons', 'Disabled Elderly Persons']","['Virtual reality (VR) technology', 'VR training', 'Virtual Reality-Based Training']","['oral care-related knowledge, attitude, self-efficacy, and intention', ""students' knowledge, attitude, self-efficacy, and intentions on providing oral healthcare""]","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",,0.0141944,"VR training positively affected students' knowledge, attitude, self-efficacy, and intentions on providing oral healthcare to disabled elderly persons.","[{'ForeName': 'Ai-Hua', 'Initials': 'AH', 'LastName': 'Chang', 'Affiliation': 'Department of Oral Hygiene, College of Dental Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Pei-Chen', 'Initials': 'PC', 'LastName': 'Lin', 'Affiliation': 'Department of Oral Hygiene, College of Dental Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Pei-Chao', 'Initials': 'PC', 'LastName': 'Lin', 'Affiliation': 'College of Nursing, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Yi-Ching', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'School of Dentistry, College of Dental Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Kabasawa', 'Affiliation': 'Oral Care for Systemic Health Support, Faculty of Dentistry, School of Oral Health Care Sciences, Graduate School, Tokyo Medical and Dental University, Tokyo 113-8510, Japan.'}, {'ForeName': 'Cheng-Yu', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Radio, TV & Film, Shih Hsin University, Taipei 116, Taiwan.'}, {'ForeName': 'Hsiao-Ling', 'Initials': 'HL', 'LastName': 'Huang', 'Affiliation': 'Department of Oral Hygiene, College of Dental Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}]",Journal of personalized medicine,['10.3390/jpm12020218']
2377,35208580,Evaluation of the Effectiveness of Dry Needling in the Treatment of Myogenous Temporomandibular Joint Disorders.,"Background and Objectives : The objective of our clinical trial was to determine the effectiveness of the deep dry needling technique (DDN) (neuromuscular deprogramming) as a first step in the treatment of temporomandibular disorders.  Methods and Materials : The double-blind randomized clinical trial comprised 36 patients meeting the inclusion criteria who had signed the corresponding informed consent form. The participants were randomly distributed into two groups, the Experimental group (Group E) and the Control group (Group C). Group E received bilateral DDN on the masseter muscle, while Group C received a simulation of the technique (PN). All the participants were evaluated three times: pre-needling, 10 min post-needling, and through a follow-up evaluation after 15 days. These evaluations included, among other tests: pain evaluation using the Visual Analog Scale (VAS) and bilateral muscle palpation with a pressure algometer; evaluation of the opening pattern and range of the mouth, articular sounds and dental occlusion using T-scans; and electromyography, which was used to evaluate the muscle tone of the masseter muscles, in order to control changes in mandibular position.  Results : Digital control of occlusion using Tec-Scan (digital occlusion analysis) showed a significant reduction both in the time of posterior disclusion and in the time needed to reach maximum force in an MI position after needling the muscle, which demonstrated that there were variations in the static position and the trajectory of the jaw. The symmetry of the arch while opening and closing the mouth was recovered in a centric relation, with an increase in the opening range of the mouth after the procedure.  Conclusions : facial pain is significantly reduced and is accompanied by a notable reduction in muscle activity after needling its trigger points.",2022,"Digital control of occlusion using Tec-Scan (digital occlusion analysis) showed a significant reduction both in the time of posterior disclusion and in the time needed to reach maximum force in an MI position after needling the muscle, which demonstrated that there were variations in the static position and the trajectory of the jaw.","['Myogenous Temporomandibular Joint Disorders', '36 patients meeting the inclusion criteria who had signed the corresponding informed consent form']","['Dry Needling', 'bilateral DDN', 'simulation of the technique (PN', 'Methods and Materials ', 'deep dry needling technique (DDN) (neuromuscular deprogramming']","['Visual Analog Scale (VAS) and bilateral muscle palpation with a pressure algometer; evaluation of the opening pattern and range of the mouth, articular sounds and dental occlusion']","[{'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0011382', 'cui_str': 'Dental occlusion'}]",36.0,0.0924972,"Digital control of occlusion using Tec-Scan (digital occlusion analysis) showed a significant reduction both in the time of posterior disclusion and in the time needed to reach maximum force in an MI position after needling the muscle, which demonstrated that there were variations in the static position and the trajectory of the jaw.","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Dib-Zakkour', 'Affiliation': 'The Surgery and Odontostomatology Doctoral Program, University of Salamanca, 37007 Salamanca, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Flores-Fraile', 'Affiliation': 'Department of Surgery, University of Salamanca, 37007 Salamanca, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Montero-Martin', 'Affiliation': 'Department of Surgery, University of Salamanca, 37007 Salamanca, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Dib-Zakkour', 'Affiliation': 'Departament of Dentistry, University of Salamanca, 37007 Salamanca, Spain.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Dib-Zaitun', 'Affiliation': 'Department of Surgery, University of Salamanca, 37007 Salamanca, Spain.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina58020256']
2378,35208888,Ten-Week Sucralose Consumption Induces Gut Dysbiosis and Altered Glucose and Insulin Levels in Healthy Young Adults.,"Sucralose consumption alters microbiome and carbohydrate metabolism in mouse models. However, there are no conclusive studies in humans. Our goals were to examine the effect of sucralose consumption on the intestinal abundance of bacterial species belonging to Actinobacteria, Bacteroidetes, and Firmicutes and explore potential associations between microbiome profiles and glucose and insulin blood levels in healthy young adults. In this open-label clinical trial, volunteers randomly drank water, as a control ( n  = 20), or 48 mg sucralose ( n  = 20), every day for ten weeks. At the beginning and the end of the study, participants were subjected to an oral glucose tolerance test (OGTT) to measure serum glucose and insulin every 15 min for 3 h and provided fecal samples to assess gut microbiota using a quantitative polymerase chain reaction. Sucralose intake altered the abundance of Firmicutes without affecting Actinobacteria or Bacteroidetes. Two-way ANOVA revealed that volunteers drinking sucralose for ten weeks showed a 3-fold increase in  Blautia coccoides  and a 0.66-fold decrease in  Lactobacillus acidophilus  compared to the controls. Sucralose consumption increased serum insulin and the area under the glucose curve compared to water. Long-term sucralose ingestion induces gut dysbiosis associated with altered insulin and glucose levels during an OGTT.",2022,Long-term sucralose ingestion induces gut dysbiosis associated with altered insulin and glucose levels during an OGTT.,"['Healthy Young Adults', 'healthy young adults']","['sucralose consumption', 'oral glucose tolerance test (OGTT', 'Sucralose consumption']","['serum insulin and the area under the glucose curve', 'Blautia coccoides', 'altered insulin and glucose levels', 'Gut Dysbiosis and Altered Glucose and Insulin Levels']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C2658870', 'cui_str': 'Blautia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C3658208', 'cui_str': 'Dysbiosis'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",,0.0433231,Long-term sucralose ingestion induces gut dysbiosis associated with altered insulin and glucose levels during an OGTT.,"[{'ForeName': 'Lucía A', 'Initials': 'LA', 'LastName': 'Méndez-García', 'Affiliation': 'Laboratory of Immunometabolism, Research Division, General Hospital of Mexico, Mexico City 06720, Mexico.'}, {'ForeName': 'Nallely', 'Initials': 'N', 'LastName': 'Bueno-Hernández', 'Affiliation': 'Laboratory for Proteomics and Metabolomics, General Hospital of Mexico, Mexico City 06720, Mexico.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Cid-Soto', 'Affiliation': 'Immunogenomics and Metabolic Diseases Laboratory, Instituto Nacional de Medicina Genómica, Mexico City 14610, Mexico.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'De León', 'Affiliation': 'Laboratory for Proteomics and Metabolomics, General Hospital of Mexico, Mexico City 06720, Mexico.'}, {'ForeName': 'Viridiana M', 'Initials': 'VM', 'LastName': 'Mendoza-Martínez', 'Affiliation': 'Laboratory for Proteomics and Metabolomics, General Hospital of Mexico, Mexico City 06720, Mexico.'}, {'ForeName': 'Aranza J', 'Initials': 'AJ', 'LastName': 'Espinosa-Flores', 'Affiliation': 'Laboratory for Proteomics and Metabolomics, General Hospital of Mexico, Mexico City 06720, Mexico.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Carrero-Aguirre', 'Affiliation': 'Laboratory for Proteomics and Metabolomics, General Hospital of Mexico, Mexico City 06720, Mexico.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Esquivel-Velázquez', 'Affiliation': 'Laboratory for Proteomics and Metabolomics, General Hospital of Mexico, Mexico City 06720, Mexico.'}, {'ForeName': 'Mireya', 'Initials': 'M', 'LastName': 'León-Hernández', 'Affiliation': 'Laboratory for Proteomics and Metabolomics, General Hospital of Mexico, Mexico City 06720, Mexico.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Viurcos-Sanabria', 'Affiliation': 'Laboratory of Immunometabolism, Research Division, General Hospital of Mexico, Mexico City 06720, Mexico.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Ruíz-Barranco', 'Affiliation': 'Clinical Nutrition Division, General Hospital of Mexico, Mexico City 06720, Mexico.'}, {'ForeName': 'Julián M', 'Initials': 'JM', 'LastName': 'Cota-Arce', 'Affiliation': 'Department of Biomedical Innovation, Center for Scientific Research and Higher Education of Ensenada (CICESE), Baja California 22860, Mexico.'}, {'ForeName': 'Angélica', 'Initials': 'A', 'LastName': 'Álvarez-Lee', 'Affiliation': 'Department of Biomedical Innovation, Center for Scientific Research and Higher Education of Ensenada (CICESE), Baja California 22860, Mexico.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'De León-Nava', 'Affiliation': 'Department of Biomedical Innovation, Center for Scientific Research and Higher Education of Ensenada (CICESE), Baja California 22860, Mexico.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Meléndez', 'Affiliation': 'Facultad de Salud Pública y Nutrición, Universidad Autónoma de Nuevo León, Monterrey 64460, Mexico.'}, {'ForeName': 'Galileo', 'Initials': 'G', 'LastName': 'Escobedo', 'Affiliation': 'Laboratory of Immunometabolism, Research Division, General Hospital of Mexico, Mexico City 06720, Mexico.'}]",Microorganisms,['10.3390/microorganisms10020434']
2379,35208884,Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies-An Open-Label Randomized Study.,"The aim of this study (ClinicalTrials.gov registration NCT04666324) was to determine the effects of a nine-strain synbiotic and simethicone on the duration of crying and the gut inflammation marker calprotectin in colicky babies aged 3-6 weeks, diagnosed using the Wessel criteria. The open-label study comprised a control group of non-colicky babies (n = 20) and two parallel treatment groups (each n = 50) to which colicky babies were randomly and equally assigned to receive the multi-strain synbiotic or simethicone orally for 28 days. Primary outcome measures were the change in daily crying duration and the level of fecal calprotectin on days 1 and 28 of the study. Administration of the synbiotic resulted in a rechange of crying duration of -7.18 min/day of treatment, while simethicone had a significantly smaller effect (-5.74 min/day). Fecal calprotectin levels in colicky babies were significantly elevated compared to those in non-colicky babies. Treatment with the nine-strain synbiotic resulted in a significant lowering of fecal calprotectin at the end of the study, while no such effect was found for simethicone. No adverse effects were reported. Study results confirm earlier findings of crying duration reductions in colicky babies by the synbiotic, an effect that might be linked to its anti-inflammatory properties.",2022,Fecal calprotectin levels in colicky babies were significantly elevated compared to those in non-colicky babies.,"['colicky babies aged 3-6 weeks, diagnosed using the Wessel criteria', 'Colicky Babies', 'n = 20) and two parallel treatment groups (each n = 50) to which colicky babies']","['multi-strain synbiotic or simethicone', 'nine-strain synbiotic and simethicone', 'synbiotic', 'control group of non-colicky babies']","['change in daily crying duration and the level of fecal calprotectin', 'Fecal calprotectin levels', 'rechange of crying duration', 'duration of crying and the gut inflammation marker calprotectin', 'fecal calprotectin', 'adverse effects', 'Fecal Calprotectin']","[{'cui': 'C0857334', 'cui_str': 'Colicky sensation quality'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0037138', 'cui_str': 'Simethicone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0857334', 'cui_str': 'Colicky sensation quality'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0699971,Fecal calprotectin levels in colicky babies were significantly elevated compared to those in non-colicky babies.,"[{'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Bernatek', 'Affiliation': 'Department of Health Sciences, Calisia University, Nowy Swiat 4, 62-800 Kalisz, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Piątek', 'Affiliation': 'Department of Health Sciences, Calisia University, Nowy Swiat 4, 62-800 Kalisz, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Pszczola', 'Affiliation': 'Department of Genetics and Animal Breeding, Faculty of Veterinary Medicine and Animal Science, Poznan University of Life Sciences, Wolynska 33, 60-637 Poznan, Poland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Krauss', 'Affiliation': 'Department of Health Sciences, Calisia University, Nowy Swiat 4, 62-800 Kalisz, Poland.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Antczak', 'Affiliation': 'State Hospital Jarocin, Szpitalna 1, 63-200 Jarocin, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Maciukajć', 'Affiliation': 'GP Clinic Brody, Stanisława Staszica 3, 27-230 Brody, Poland.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Sommermeyer', 'Affiliation': 'Department of Health Sciences, Calisia University, Nowy Swiat 4, 62-800 Kalisz, Poland.'}]",Microorganisms,['10.3390/microorganisms10020430']
2380,35206134,"Cranial Electrotherapy Stimulation to Improve the Physiology and Psychology Response, Response-Ability, and Sleep Efficiency in Athletes with Poor Sleep Quality.","Athletes often have poor sleep quality before a competition. Sleep quality can stabilize mood and improve sports performance. The randomized controlled study explored the effects of cranial electrotherapy stimulation (CES) on the physiology, psychology, response-ability, and sleep quality of athletes who had poor sleep quality before a competition. Athletes who had poor sleep quality (Pittsburgh Sleep Quality Scale score > 5) and had a competition in less than 2 months were recruited. The athletes were grouped into the CES group, which received a 2-week CES treatment ( n  = 20, age = 21.55 ± 2.26 years), and a placebo group ( n  = 20, age = 21.05 ± 1.46 years), which received a 2-week sham CES treatment. We performed biochemical analysis, a simple reaction time test, choice reaction time tests, the Profile of Mood States, heart rate variability (HRV), and an Actigraphy activity recorder to measure outcomes before and after the interventions. Our results revealed no significant differences in blood urea nitrogen, creatine phosphate, testosterone, cortisol, and saliva pH between and within groups ( p  > 0.05). Significant decreases in negative mood states (i.e., anger, tension, and depression) and choice reaction time in the CES group were noted ( p  < 0.05), moreover, the anger, tension, and depression mood decreased from 0.36 ± 0.45 (95% CI = 0.16-0.55), 1.62 ± 0.97 (95% CI = 1.19-2.04), and 1.67 ± 1.06 (95% CI = 1.20-2.13) to 0.11 ± 0.20 (95% CI = 0.02-0.19,  p  = 0.03), 1.12 ± 0.74 (95% CI = 0.79-1.44,  p  = 0.04), and 0.81 ± 0.75 (95% CI = 0.48-1.13,  p  = 0.001), respectively. Additionally, choice reaction time was decreased from 420.85 ± 41.22 ms (95% CI = 402.78-438.91) to 399.90 ± 36.71 ms (95% CI = 383.81-415.98,  p  = 0.04) and was also noted in the CES group. For HRV, and Actigraphy activity for sleep measure, the low-frequency (LF)/high-frequency (HF) ratios changed from 1.80 ± 1.39 (95% CI = 1.19-2.40) to 1.21 ± 0.73 (95% CI = 0.89-1.53,  p  = 0.10), and sleep efficiency decreased from 87.94 ± 6.76% (95% CI = 84.97-90.90) to 81.75 ± 9.62% (95% CI = 77.53-85.96,  p  = 0.02) in the CES group. The change in LF/HF after the trial were found between CES and placebo groups (p < 0.05). Yet, the decrease in sleep efficiency in the placebo group were noted ( p  < 0.05). However, we found that the regression line for sleep efficiency was decreased less during the study while using CES. The CES intervention could reduce negative emotions, improve choice reaction times, enhance the parasympathetic and sympathetic nerve activity imbalances, and slow sleep efficiency deterioration. Regardless, small effect sizes of the application of CES on psychology response, response-ability, and sleep efficiency were concluded in athletes with poor sleep quality before a competition.",2022,The change in LF/HF after the trial were found between CES and placebo groups (p < 0.05).,"['athletes who had poor sleep quality before a competition', 'group ( n  = 20, age = 21.05 ± 1.46 years', 'Athletes who had poor sleep quality (Pittsburgh Sleep Quality Scale score > 5) and had a competition in less than 2 months were recruited', 'Athletes with Poor Sleep Quality']","['2-week sham CES treatment', 'placebo', 'Cranial Electrotherapy Stimulation', 'CES treatment', 'cranial electrotherapy stimulation (CES', 'CES intervention']","['Physiology and Psychology Response, Response-Ability, and Sleep Efficiency', 'choice reaction time', 'sleep efficiency', 'psychology response, response-ability, and sleep efficiency', 'Profile of Mood States, heart rate variability (HRV), and an Actigraphy activity', 'For HRV, and Actigraphy activity for sleep measure, the low-frequency (LF)/high-frequency (HF) ratios', 'blood urea nitrogen, creatine phosphate, testosterone, cortisol, and saliva pH', 'change in LF/HF', 'negative emotions, improve choice reaction times, enhance the parasympathetic and sympathetic nerve activity imbalances, and slow sleep efficiency deterioration', 'negative mood states (i.e., anger, tension, and depression) and choice reaction time', 'physiology, psychology, response-ability, and sleep quality', 'anger, tension, and depression mood']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191363', 'cui_str': '1.46'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0031634', 'cui_str': 'fosfocreatine'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}]",,0.117834,The change in LF/HF after the trial were found between CES and placebo groups (p < 0.05).,"[{'ForeName': 'Wen-Dien', 'Initials': 'WD', 'LastName': 'Chang', 'Affiliation': 'Department of Sport Performance, National Taiwan University of Sport, Taichung 404401, Taiwan.'}, {'ForeName': 'Yung-An', 'Initials': 'YA', 'LastName': 'Tsou', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, China Medical University Hospital, Taichung 40402, Taiwan.'}, {'ForeName': 'Yi-Ying', 'Initials': 'YY', 'LastName': 'Chen', 'Affiliation': 'Department of Sport Performance, National Taiwan University of Sport, Taichung 404401, Taiwan.'}, {'ForeName': 'Bao-Lien', 'Initials': 'BL', 'LastName': 'Hung', 'Affiliation': 'Department of Sports Medicine, China Medical University, Taichung 406040, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph19041946']
2381,35206520,Preliminary Effectiveness of mHealth App-Based Pelvic Floor Muscle Training among Pregnant Women to Improve Their Exercise Adherence: A Pilot Randomised Control Trial.,"This pilot randomised control trial (RCT) aimed to evaluate the feasibility and preliminary effectiveness of conducting a full-powered trial for a newly developed pelvic floor muscle training (PFMT) app among pregnant women with urinary incontinence (UI) in Malaysia. This was a prospective, single-centre, single-blind, parallel, randomised controlled, pilot feasibility study-the Kegel Exercise Pregnancy Training app (KEPT app) trial. In total, 26 pregnant women with urinary incontinence from an urban healthcare clinic were recruited and randomly assigned to either intervention or waitlist control group. The intervention group received the KEPT app, while the control group received usual antenatal care (waitlist control). Of the 26 pregnant women, 16 (61.5%) completed the two-month follow-up. The recruitment rate was 54.2%, and the retention rate was 62.5% in the intervention group and 60% in the control group. There was a significant difference between intervention and control groups' baseline measurement in the severity of UI ( p  = 0.031). The app improved their knowledge ( p  = 0.011) and self-efficacy ( p  = 0.038) after the first month and attitude ( p  = 0.034) after two months of intervention, compared with the control group. This study supports the feasibility of our future cluster RCT. The KEPT app demonstrates a promising effect in improving PFMT attitude and self-efficacy and potentially enhancing exercise adherence among pregnant women with UI. Trial registration: This study was prospectively registered on ClinicalTrials.gov on 19 February 2021 (NCT04762433).",2022,"The app improved their knowledge ( p  = 0.011) and self-efficacy ( p  = 0.038) after the first month and attitude ( p  = 0.034) after two months of intervention, compared with the control group.","['pregnant women with UI', 'Pregnant Women to Improve Their Exercise Adherence', 'pregnant women with urinary incontinence (UI) in Malaysia', '26 pregnant women with urinary incontinence from an urban healthcare clinic', '26 pregnant women, 16 (61.5%) completed the two-month follow-up']","['intervention or waitlist control group', 'pelvic floor muscle training (PFMT', 'mHealth App-Based Pelvic Floor Muscle Training', 'Kegel Exercise Pregnancy Training', 'KEPT app, while the control group received usual antenatal care (waitlist control']","['recruitment rate', 'self-efficacy', 'retention rate', 'PFMT attitude and self-efficacy', 'exercise adherence']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0262718', 'cui_str': 'Pelvic floor exercises'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",26.0,0.0179041,"The app improved their knowledge ( p  = 0.011) and self-efficacy ( p  = 0.038) after the first month and attitude ( p  = 0.034) after two months of intervention, compared with the control group.","[{'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Jaffar', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Sherina', 'Initials': 'S', 'LastName': 'Mohd Sidik', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Chai Nien', 'Initials': 'CN', 'LastName': 'Foo', 'Affiliation': 'Department of Population Medicine, Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Kajang 43000, Malaysia.'}, {'ForeName': 'Noor Azimah', 'Initials': 'NA', 'LastName': 'Muhammad', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia.'}, {'ForeName': 'Rosliza', 'Initials': 'R', 'LastName': 'Abdul Manaf', 'Affiliation': 'Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Nazhatussima', 'Initials': 'N', 'LastName': 'Suhaili', 'Affiliation': 'Klinik Kesihatan Ampang, Ministry of Health, Ampang 68000, Malaysia.'}]",International journal of environmental research and public health,['10.3390/ijerph19042332']
2382,35206481,An Exploratory Study on the Effectiveness of Virtual Reality Analgesia for Children and Adolescents with Kidney Diseases Undergoing Venipuncture.,"The current study evaluated the effectiveness of VR analgesia among pediatric and adolescent patients with kidney disease undergoing venipuncture. Patients at an Italian Children's hospital (N = 82, age range 7-17 years) undergoing venipuncture were randomly assigned to a No VR group (non-medical conversation) vs. a Yes VR group (VR analgesia). After the procedure, patients gave 0-10 Verbal Numeric Pain Scale ratings. Compared with patients in the No VR Group, patients in the Yes VR group reported significantly lower ""Pain intensity""(No VR mean = 2.74, SD = 2.76 vs. Yes VR mean = 1.56, SD = 1.83) and the VR group also rated ""Pain unpleasantness"" significantly lower than the No VR group (No VR mean = 2.41, SD = 0.94 vs. Yes VR mean = 1.17, SD = 1.80). Patients distracted with VR also reported having significantly more fun during the venipuncture procedure. No side effects emerged. In addition to reducing pain intensity, VR has the potential to make venipuncture a more fun and less unpleasant experience for children with CKD, as measured in the present study for the first time. Finally, in exploratory analyses, children aged 7-11 in the VR group reported 55% lower worst pain than control subjects in the same age range, whereas children aged 12 to 17 in the VR group only reported 35% lower worst pain than control subjects. Additional research and development using more immersive VR is recommended.",2022,"Compared with patients in the No VR Group, patients in the Yes VR group reported significantly lower ""Pain intensity""(No VR mean = 2.74, SD = 2.76 vs. Yes","['children with CKD', ""Patients at an Italian Children's hospital (N = 82, age range 7-17 years) undergoing"", 'pediatric and adolescent patients with kidney disease undergoing venipuncture', 'Children and Adolescents with Kidney Diseases Undergoing Venipuncture']","['Virtual Reality Analgesia', 'venipuncture', 'VR analgesia', 'No VR group (non-medical conversation) vs. a Yes VR group (VR analgesia']","['worst pain', 'Verbal Numeric Pain Scale ratings', 'rated ""Pain unpleasantness', 'Pain intensity""(No VR']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1298907', 'cui_str': 'Yes'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]",82.0,0.0329861,"Compared with patients in the No VR Group, patients in the Yes VR group reported significantly lower ""Pain intensity""(No VR mean = 2.74, SD = 2.76 vs. Yes","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Atzori', 'Affiliation': 'Department of Health Sciences, University of Florence, 50134 Florence, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vagnoli', 'Affiliation': ""Pediatric Psychology Service, Meyer Children's Hospital, 50139 Florence, Italy.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Graziani', 'Affiliation': ""Pediatric Psychology Service, Meyer Children's Hospital, 50139 Florence, Italy.""}, {'ForeName': 'Hunter G', 'Initials': 'HG', 'LastName': 'Hoffman', 'Affiliation': 'Department of Mechanical Engineering HPL, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Sampaio', 'Affiliation': 'Department of Psychology, University of Coimbra, 3000-115 Coimbra, Portugal.'}, {'ForeName': 'Wadee', 'Initials': 'W', 'LastName': 'Alhalabi', 'Affiliation': 'Department of Computer Science, King Abdulaziz University, Jeddah 21589, Saudi Arabia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Messeri', 'Affiliation': ""Pain Therapy and Palliative Care, Meyer Children's Hospital, 50139 Florence, Italy.""}, {'ForeName': 'Rosapia', 'Initials': 'R', 'LastName': 'Lauro-Grotto', 'Affiliation': 'Department of Health Sciences, University of Florence, 50134 Florence, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph19042291']
2383,35206455,Advancing Behavioral Intervention and Theory Development for Mobile Health: The HeartSteps II Protocol.,"Background:  Recent advances in mobile and wearable technologies have led to new forms of interventions, called ""Just-in-Time Adaptive Interventions"" (JITAI). JITAIs interact with the individual at the most appropriate time and provide the most appropriate support depending on the continuously acquired Intensive Longitudinal Data (ILD) on participant physiology, behavior, and contexts. These advances raise an important question: How do we model these data to better understand and intervene on health behaviors? The HeartSteps II study, described here, is a Micro-Randomized Trial (MRT) intended to advance both intervention development and theory-building enabled by the new generation of mobile and wearable technology.  Methods : The study involves a year-long deployment of HeartSteps, a JITAI for physical activity and sedentary behavior, with 96 sedentary, overweight, but otherwise healthy adults. The central purpose is twofold: (1) to support the development of modeling approaches for operationalizing dynamic, mathematically rigorous theories of health behavior; and (2) to serve as a testbed for the development of learning algorithms that JITAIs can use to individualize intervention provision in real time at multiple timescales.  Discussion and Conclusions : We outline an innovative modeling paradigm to model and use ILD in real- or near-time to individually tailor JITIAs.",2022,"The study involves a year-long deployment of HeartSteps, a JITAI for physical activity and sedentary behavior, with 96 sedentary, overweight, but otherwise healthy adults.","['96 sedentary, overweight, but otherwise healthy adults']",[],[],"[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],[],96.0,0.0312797,"The study involves a year-long deployment of HeartSteps, a JITAI for physical activity and sedentary behavior, with 96 sedentary, overweight, but otherwise healthy adults.","[{'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spruijt-Metz', 'Affiliation': 'Center for Economic and Social Research, Department of Psychology, University of Southern California, Los Angeles, CA 90089, USA.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Marlin', 'Affiliation': 'Manning College of Information and Computer Sciences, University of Massachusetts Amherst, Amherst, MA 01003, USA.'}, {'ForeName': 'Misha', 'Initials': 'M', 'LastName': 'Pavel', 'Affiliation': 'Khoury College of Computer Sciences, Northeastern University, Boston, MA 02115, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Rivera', 'Affiliation': 'Control Systems Engineering Laboratory, School for Engineering of Matter, Transport, Energy, Arizona State University, Tempe, AZ 85287, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hekler', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, University of California, San Diego, CA 92093, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'De La Torre', 'Affiliation': 'Department of Population and Public Health Sciences, University of Southern California, Los Angeles, CA 90032, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Mistiri', 'Affiliation': 'Control Systems Engineering Laboratory, School for Engineering of Matter, Transport, Energy, Arizona State University, Tempe, AZ 85287, USA.'}, {'ForeName': 'Natalie M', 'Initials': 'NM', 'LastName': 'Golaszweski', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, University of California, San Diego, CA 92093, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Population and Public Health Sciences, University of Southern California, Los Angeles, CA 90032, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Braga De Braganca', 'Affiliation': 'Department of Population and Public Health Sciences, University of Southern California, Los Angeles, CA 90032, USA.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Tung', 'Affiliation': 'Manning College of Information and Computer Sciences, University of Massachusetts Amherst, Amherst, MA 01003, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Kha', 'Affiliation': 'Control Systems Engineering Laboratory, School for Engineering of Matter, Transport, Energy, Arizona State University, Tempe, AZ 85287, USA.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Klasnja', 'Affiliation': 'School of Information, University of Michigan, Ann Arbor, MI 48109, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph19042267']
2384,35206449,Physical Activity Levels and Screen Time among Youth with Overweight/Obesity Using Mental Health Services.,"Youth with mental illness have higher levels of obesity than children in the general population. Both regular physical activity and limited screen time have been recommended to reduce and prevent childhood obesity. This study examines accelerometer-based moderate-vigorous physical activity (MVPA) and screen time among youth with overweight/obesity issues who are receiving mental health care. This study looked at a 12-month weight management randomized clinical trial for overweight/obese youth aged 8-18 years who are receiving mental health services. At baseline, MVPA was assessed using accelerometers, and screen time was self-reported. Among 100 youth, 43% were female, 44% were Black, and 48% were <13 years old. In an adjusted general linear model, higher levels of MVPA were associated with the younger age group ( p  = 0.012), male participants ( p  = 0.013), and lower BMI z-scores ( p  = 0.014). In a separate model, higher screen time was associated with participants who were Black ( p  = 0.007). Achieving optimal cardiovascular health at the population level requires an understanding of the groups that are most in need of additional assistance. These data reinforce that targeted lifestyle approaches to promote increased physical activity and decreased screen time among overweight/obese youth using mental health services may need additional tailoring for sex, age, and race subgroups.",2022,"In a separate model, higher screen time was associated with participants who were Black ( p  = 0.007).","['youth with overweight/obesity issues who are receiving mental health care', '100 youth, 43% were female, 44% were Black, and 48% were <13 years old', 'Youth with mental illness', 'Youth with Overweight/Obesity Using Mental Health Services', 'overweight/obese youth aged 8-18 years who are receiving mental health services']",['accelerometer-based moderate-vigorous physical activity (MVPA'],"['screen time', 'lower BMI z-scores', 'levels of MVPA', 'physical activity', 'Physical Activity Levels and Screen Time']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",43.0,0.0527437,"In a separate model, higher screen time was associated with participants who were Black ( p  = 0.007).","[{'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Jerome', 'Affiliation': 'Department of Kinesiology, Towson University, Towson, MD 21252, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Fink', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Brady', 'Affiliation': 'Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'Deborah R', 'Initials': 'DR', 'LastName': 'Young', 'Affiliation': 'Kaiser Permanente Southern California, Pasadena, CA 91101, USA.'}, {'ForeName': 'Faith B', 'Initials': 'FB', 'LastName': 'Dickerson', 'Affiliation': 'Sheppard Pratt, Baltimore, MD 21204, USA.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Goldsholl', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Findling', 'Affiliation': 'Department of Psychiatry, Virginia Commonwealth University, Richmond, VA 23284, USA.'}, {'ForeName': 'Ekaterina A', 'Initials': 'EA', 'LastName': 'Stepanova', 'Affiliation': 'Department of Psychiatry, Virginia Commonwealth University, Richmond, VA 23284, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Scheimann', 'Affiliation': 'Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'Arlene T', 'Initials': 'AT', 'LastName': 'Dalcin', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Terry', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Gennusa', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Gail L', 'Initials': 'GL', 'LastName': 'Daumit', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph19042261']
2385,35206443,Heart Rate Variability and Sympathetic Activity Is Modulated by Very Low-Calorie Ketogenic Diet.,"Obesity is characterized by an energy imbalance and by the accumulation of visceral adipose tissue. The energy balance is controlled by a complex set of balanced physiological systems that provide hunger and satiety signals to the brain and regulate the body's ability to consume energy. The central nervous system controls the metabolic state, influencing the activity of other systems and receiving information from them. Heart rate variability (HRV) is the natural variability of the heart rate in response to several factors. HRV is related to the interaction between the SNS and the parasympathetic. In the light of this evidence, the aim of this study is to investigate the possible effects of the two different dietary regimens such as very low-calorie ketogenic diet (VLCKD) vs. low caloric diet (LCD), on the functions of the nervous system, with particular attention to the autonomous control of heart rate variability (HRV). A total of 26 obese subjects underwent diet therapy in order to reduce body weight; they were also randomly divided into two groups: the VLCKD group and the LCD group. Our results showed that in both groups, there is a reduction in heart rate as an indicator of sympathetic activity; we found a statistically significant variation only in the VLCKD group. Therefore, this study supports the notion that the sympathovagal balance can be modulated by a specific diet, but further studies are needed to clarify the molecular pathway undergoing this modulation.",2022,"Our results showed that in both groups, there is a reduction in heart rate as an indicator of sympathetic activity; we found a statistically significant variation only in the VLCKD group.",['26 obese subjects underwent'],"['LCD', 'low-calorie ketogenic diet (VLCKD) vs. low caloric diet (LCD', 'diet therapy', 'VLCKD']","['Heart rate variability (HRV', 'Heart Rate Variability and Sympathetic Activity', 'heart rate variability (HRV', 'heart rate']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",26.0,0.0106292,"Our results showed that in both groups, there is a reduction in heart rate as an indicator of sympathetic activity; we found a statistically significant variation only in the VLCKD group.","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Polito', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Foggia, 71100 Foggia, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Valenzano', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Foggia, 71100 Foggia, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Monda', 'Affiliation': 'Department of Experimental Medicine, Section of Human Physiology and Unit of Dietetics and Sports Medicine, University of Campania ""Luigi Vanvitelli"", 80138 Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Cibelli', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Foggia, 71100 Foggia, Italy.'}, {'ForeName': 'Marcellino', 'Initials': 'M', 'LastName': 'Monda', 'Affiliation': 'Department of Experimental Medicine, Section of Human Physiology and Unit of Dietetics and Sports Medicine, University of Campania ""Luigi Vanvitelli"", 80138 Naples, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Messina', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Foggia, 71100 Foggia, Italy.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Villano', 'Affiliation': 'Department of Experimental Medicine, Section of Human Physiology and Unit of Dietetics and Sports Medicine, University of Campania ""Luigi Vanvitelli"", 80138 Naples, Italy.'}, {'ForeName': 'Antonietta', 'Initials': 'A', 'LastName': 'Messina', 'Affiliation': 'Department of Experimental Medicine, Section of Human Physiology and Unit of Dietetics and Sports Medicine, University of Campania ""Luigi Vanvitelli"", 80138 Naples, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph19042253']
2386,35206959,"The Effect of Exposure to ""Exemption"" Video Advertisements for Functional Foods: A Randomized Control Study in Japan.","Previous content analysis of video advertisements for functional foods identified ""Exemption"" advertisements. ""Exemption"" advertisements may imply to the audiences that ""By taking functional foods, I can adopt unhealthy behaviors or I don't have to adopt healthy behaviors"". In the context of Compensatory Health Beliefs (CHBs), this study refers to these beliefs as functional foods related to CHBs (FF-CHBs). This study aimed to assess the effects of exposure to ""Exemption"" advertisements for fat-reduction functional foods on audiences. The main hypothesis is exposure to ""Exemption"" video advertisements increases participants' FF-CHBs. Participants ( n   =  788) were randomly assigned to an intervention group that viewed three video advertisements or a control group and answered online self-administered questionnaires. Intervention videos were three videos with the highest number of views per month from among the ""Exemption"" video advertisements. Control videos were about how to brew green tea. FF-CHBs was assessed before and after the intervention. The intervention group showed significantly greater FF-CHBs after intervention (mean = 2.37 vs. 2.11,  p  < 0.001, η 2  = 0.026) compared with the control group. ""Exemption"" functional foods video advertisements increased FF-CHBs that can lead to adopting unhealthy behaviors and avoiding healthy behaviors. The content of these functional foods video advertisements should be improved to promote public health.",2022,"The intervention group showed significantly greater FF-CHBs after intervention (mean = 2.37 vs. 2.11,  p  < 0.001, η 2  = 0.026) compared with the control group.","['Participants ( n \u2009 = \u2009788', 'Japan']","['Exemption"" advertisements', 'Exposure to ""Exemption"" Video Advertisements', 'intervention group that viewed three video advertisements or a control group and answered online self-administered questionnaires']",['FF-CHBs'],"[{'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0814098', 'cui_str': 'Health belief'}]",788.0,0.0416253,"The intervention group showed significantly greater FF-CHBs after intervention (mean = 2.37 vs. 2.11,  p  < 0.001, η 2  = 0.026) compared with the control group.","[{'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Iye', 'Affiliation': 'Department of Health Communication, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Okuhara', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Eiko', 'Initials': 'E', 'LastName': 'Goto', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Furukawa', 'Affiliation': 'Department of Health Communication, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kiuchi', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare10020345']
2387,35206946,Effects of Adding Aquatic-to-Land-Based Physiotherapy Programs for Shoulder Joint Position Sense Rehabilitation.,"There is limited evidence regarding the effects of aquatic-based physiotherapy on shoulder proprioception following post-traumatic injury to the joint. The main aim of this study was to investigate the effects of additional aquatic-based rehabilitation to a land-based physiotherapy program on shoulder joint position sense (JPS) rehabilitation. Forty-four individuals (mean age 44.50 ± 10.11) who had suffered a post-traumatic shoulder injury less than five months previously were pseudo-randomly allocated equally into a control group (9 females, 13 males) and experimental group (6 females, 16 males). Both groups received individualized standard land-based physiotherapy on average for 50 min per session, with five sessions per week for four consecutive weeks. The experimental group received an additional 30 min of personalized aquatic-based therapy during each session. Shoulder JPS was assessed by flexion (60°), extension (25°), abduction (60°), internal rotation (35°) and external rotation (35°) positions prior, halfway through, and after the intervention. Shoulder JPS improved significantly for all positions for both the control group ( p  < 0.03) and the experimental group ( p  < 0.01). No significant differences between the control group and the experimental group were found for change in shoulder JPS over time. Our results indicate that shoulder JPS can be significantly improved among individuals with post-traumatic injury to the joint through four weeks of personalized physiotherapy. The addition of aquatic-based exercises to standard land-based therapy did not, however, show significant benefits, and thus cannot be recommended for the improvement of shoulder JPS based on our findings.",2022,Shoulder JPS improved significantly for all positions for both the control group ( p  < 0.03) and the experimental group ( p  < 0.01).,"['Forty-four individuals (mean age 44.50 ± 10.11) who had suffered a post-traumatic shoulder injury less than five months previously were pseudo-randomly allocated equally into a control group (9 females, 13 males) and experimental group (6 females, 16 males', 'Shoulder Joint Position Sense Rehabilitation']","['additional 30 min of personalized aquatic-based therapy', 'Adding Aquatic-to-Land-Based Physiotherapy Programs', 'aquatic-based physiotherapy', 'additional aquatic-based rehabilitation to a land-based physiotherapy program', 'individualized standard land-based physiotherapy']","['shoulder joint position sense (JPS) rehabilitation', 'change in shoulder JPS', 'shoulder proprioception', 'Shoulder JPS']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0149776', 'cui_str': 'Injury of shoulder region'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]",,0.0172751,Shoulder JPS improved significantly for all positions for both the control group ( p  < 0.03) and the experimental group ( p  < 0.01).,"[{'ForeName': 'Alexandra Camelia', 'Initials': 'AC', 'LastName': 'Gliga', 'Affiliation': 'Institution Organizing University Doctoral Studies of George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, 540139 Targu Mures, Romania.'}, {'ForeName': 'Nicolae Emilian', 'Initials': 'NE', 'LastName': 'Neagu', 'Affiliation': 'Department of Functional and Complementary Sciences, Faculty of Medicine, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, 540139 Targu Mures, Romania.'}, {'ForeName': 'Horatiu Valeriu', 'Initials': 'HV', 'LastName': 'Popoviciu', 'Affiliation': 'Department of Clinical Sciences and Internal Medicine, Faculty of Medicine, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, 540139 Targu Mures, Romania.'}, {'ForeName': 'Tiberiu', 'Initials': 'T', 'LastName': 'Bataga', 'Affiliation': 'Institution Organizing University Doctoral Studies of George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, 540139 Targu Mures, Romania.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare10020332']
2388,35206887,Innovative Nutrition Education: A Color-Coded Tool for Individuals with Low Literacy Level.,"(1) Background: The food exchange system was developed to serve as an educational tool in helping individuals plan their own meals. This study aimed to develop a friendly-user food exchange list for individuals with a low literacy level; (2) Methods: A two-group, pre-test/post-test research study aimed to develop a friendly-user food exchange list for individuals with a low literacy level. Thirty female workers of low literacy were recruited. Participants were divided into two groups. Group one was taught how to use the standard exchange system, while group two was taught how to use the modified exchange system. Each participant was assigned a task of prepare a meal with a specified caloric content and macronutrient distribution. The task was assigned before and after the exchange list education session. Groups' differences were tested using the chi-square test, and the analysis of variance (ANOVA); (3) Results: A higher percentage of participants in group two were able to plan daily diets that achieved the recommendations of fruits ( p  = 0.02), protein ( p  = 0.03), dairy ( p  < 0.001), carbohydrates ( p  < 0.001), and calories ( p  < 0.001). Moreover, diet plans prepared by group two had a higher healthy eating index ( p  < 0.001) when compared to diet plans prepared by group one. The modified exchange lists are a friendly-user tool that can be implemented for individuals with low literacy, since it relies on visual techniques.",2022,"Moreover, diet plans prepared by group two had a higher healthy eating index ( p  < 0.001) when compared to diet plans prepared by group one.","['Thirty female workers of low literacy were recruited', 'individuals with a low literacy level', 'individuals with a low literacy level; (2) Methods', 'Individuals with Low Literacy Level']",[],['healthy eating index'],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],"[{'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}]",30.0,0.0518836,"Moreover, diet plans prepared by group two had a higher healthy eating index ( p  < 0.001) when compared to diet plans prepared by group one.","[{'ForeName': 'Hiba', 'Initials': 'H', 'LastName': 'Bawadi', 'Affiliation': 'Department of Human Nutrition, College of Health Sciences, QU Health, Qatar University, Doha P.O. Box 2713, Qatar.'}, {'ForeName': 'Ghadir Fakhri', 'Initials': 'GF', 'LastName': 'Al-Jayyousi', 'Affiliation': 'Department of Public Health, College of Health Sciences, QU Health, Qatar University, Doha P.O. Box 2713, Qatar.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Shabana', 'Affiliation': 'Department of Human Nutrition, College of Health Sciences, QU Health, Qatar University, Doha P.O. Box 2713, Qatar.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Boutefnouchet', 'Affiliation': 'Department of Human Nutrition, College of Health Sciences, QU Health, Qatar University, Doha P.O. Box 2713, Qatar.'}, {'ForeName': 'Sereen', 'Initials': 'S', 'LastName': 'Eljazzar', 'Affiliation': 'Department of Human Nutrition, College of Health Sciences, QU Health, Qatar University, Doha P.O. Box 2713, Qatar.'}, {'ForeName': 'Shrooq', 'Initials': 'S', 'LastName': 'Ismail', 'Affiliation': 'Department of Human Nutrition, College of Health Sciences, QU Health, Qatar University, Doha P.O. Box 2713, Qatar.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare10020272']
2389,35206872,Immediate Effects of Single-Session High-Velocity Training for Lateral Trunk Movement on Gait Function in Early Postoperative Patients after Total Hip Arthroplasty: A Nonrandomized Controlled Trial.,"BACKGROUND


Total Hip Arthroplasty (THA) is an effective method for relieving pain and improving gait function. However, THA patients demonstrate slow gait speed at discharge. Rehabilitation programs after THA require the immediate improvement of gait speed early in the postoperative period. To examine the immediate effects of seated side tapping training (SSTT), which focuses on lateral trunk movement and movement velocity, on gait function in early postoperative THA patients, the methods were as follows: The SSTT group performed five repetitions of a task in which they moved their trunks laterally to alternately touch markers to their left and right side as quickly as possible 10 times in a seated position. One set of SSTT lasted approximately 3 min. The control group rested in a seated position for 10 min.
RESULTS


Significant interactions were observed for gait speed, stride time, and stride time coefficient of variability. The SSTT group demonstrated significant pre-post-intervention improvement in gait speed, stride time, and coefficient of variability.
CONCLUSIONS


SSTT improved both gait speed and gait stability and can be performed easily and safely. Therefore, single-session high-velocity trunk training may be an effective method to improve gait function immediately in early postoperative THA patients.",2022,"To examine the immediate effects of seated side tapping training (SSTT), which focuses on lateral trunk movement and movement velocity, on gait function in early postoperative THA patients, the methods were as follows:","['early postoperative THA patients', 'Early Postoperative Patients after Total Hip Arthroplasty', 'early postoperative THA patients, the methods were as follows']","['Total Hip Arthroplasty (THA', 'Single-Session High-Velocity Training', 'seated side tapping training (SSTT']","['gait speed, stride time, and coefficient of variability', 'slow gait speed', 'gait function', 'Gait Function', 'gait speed and gait stability', 'gait speed, stride time, and stride time coefficient of variability']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.0219863,"To examine the immediate effects of seated side tapping training (SSTT), which focuses on lateral trunk movement and movement velocity, on gait function in early postoperative THA patients, the methods were as follows:","[{'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Honma', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, Habikino 583-8555, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yano', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, Habikino 583-8555, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, Habikino 583-8555, Japan.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Ohmine', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, Habikino 583-8555, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Wanaka', 'Affiliation': 'Department of Rehabilitation, Kobe Rosai Hospital, Kobe 651-0053, Japan.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Senzaki', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, Habikino 583-8555, Japan.'}, {'ForeName': 'Atsuki', 'Initials': 'A', 'LastName': 'Kanayama', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, Habikino 583-8555, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Oonishi', 'Affiliation': 'Department of Rehabilitation, Tominaga Hospital, Osaka 556-0017, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Iwata', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, Habikino 583-8555, Japan.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare10020256']
2390,35206866,Clinical Experience of High Frequency and Low Frequency TENS in Treatment of Diabetic Neuropathic Pain in Russia.,"BACKGROUND


Transcutaneous electrical nerve stimulation (TENS) is presently one of the main methods of treatment for neuropathic pain in type II diabetes mellitus. The discussion about which TENS frequency is more effective in the treatment of neuropathic pain has been ongoing for many years. Despite this, the response of different aspects of neuropathic pain to various TENS modalities has not been sufficiently studied.
AIM


To analyze changes in characteristics of neuropathic pain depending on the frequency of TENS.
MATERIALS AND METHODS


Seventy-five Russian diabetic patients with painful distal axonal neuropathy were enrolled in the study. Patients were assigned to three groups: in the HF TENS group, 25 patients received standard drug therapy (Alpha-lipoic acid, Pentoxifylline, Vitamin B12, Gabapentin) + high-frequency TENS (HF); in the LF TENS group, 25 patients received standard drug therapy (Alpha-lipoic acid, Pentoxifylline, Vitamin B12, Gabapentin) + low-frequency TENS (LF); in the control group, 25 patients underwent just standard drug therapy (Alpha-lipoic acid, Pentoxifylline, Vitamin B12, Gabapentin). Pain intensity was calculated before and after treatment with visual analogue scale (VAS), McGill pain questionnaire (MPQ), Douleur Neuropathique 4 Questions (DN4) and Pain Drawing.
RESULTS


TENS increased the therapeutic effect of standard drug therapy, in the treatment of neuropathic pain, by 65.9% and prolonged its efficacy by 31% for up to 6 months after treatment. HF TENS had a more pronounced analgesic effect than LF TENS based on VAS (34.7%), sensory (57.6%) MPQ dimensions and DN4 (21%). Affective MPQ dimension with the use of LF TENS was lower than HF TENS by 34.7% immediately after treatment, by 47.3% after 2 months and by 34.8% after 6 months of the follow-up period.
CONCLUSION


There are significant differences between HF and LF TENS based on pain assessment using various pain scales. This reflects the distinctive effects of different TENS modalities on different aspects of neuropathic pain.",2022,"HF TENS had a more pronounced analgesic effect than LF TENS based on VAS (34.7%), sensory (57.6%) MPQ dimensions and DN4 (21%).","['type II diabetes mellitus', '25 patients underwent', 'Seventy-five Russian diabetic patients with painful distal axonal neuropathy were enrolled in the study', 'Diabetic Neuropathic Pain in Russia']","['standard drug therapy (Alpha-lipoic acid, Pentoxifylline, Vitamin B12, Gabapentin) + high-frequency TENS (HF', 'just standard drug therapy (Alpha-lipoic acid, Pentoxifylline, Vitamin B12, Gabapentin', 'standard drug therapy (Alpha-lipoic acid, Pentoxifylline, Vitamin B12, Gabapentin) + low-frequency TENS (LF', 'Transcutaneous electrical nerve stimulation (TENS', 'HF TENS', 'TENS']","['Pain intensity', 'visual analogue scale (VAS), McGill pain questionnaire (MPQ), Douleur Neuropathique 4 Questions (DN4) and Pain Drawing', 'therapeutic effect', 'analgesic effect', 'neuropathic pain', 'Affective MPQ dimension']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0035967', 'cui_str': 'Russian language'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0270921', 'cui_str': 'Axonal neuropathy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",75.0,0.0271989,"HF TENS had a more pronounced analgesic effect than LF TENS based on VAS (34.7%), sensory (57.6%) MPQ dimensions and DN4 (21%).","[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Al-Zamil', 'Affiliation': ""Department of Physiotherapy, Faculty of Continuing Medical Education, Peoples' Friendship University of Russia, 117198 Moscow, Russia.""}, {'ForeName': 'Inessa A', 'Initials': 'IA', 'LastName': 'Minenko', 'Affiliation': 'Department of Sports Medicine and Medical Rehabilitation, Sechenov First Moscow State Medical University, 119435 Moscow, Russia.'}, {'ForeName': 'Natalia G', 'Initials': 'NG', 'LastName': 'Kulikova', 'Affiliation': ""Department of Physiotherapy, Faculty of Continuing Medical Education, Peoples' Friendship University of Russia, 117198 Moscow, Russia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Alade', 'Affiliation': 'Well Street Surgery, London E9 7TA, UK.'}, {'ForeName': 'Marina M', 'Initials': 'MM', 'LastName': 'Petrova', 'Affiliation': 'Shared Core Facilities ""Molecular and Cell Technologies"", V. F. Voino-Yasenetsky Krasnoyarsk State Medical University, 660022 Krasnoyarsk, Russia.'}, {'ForeName': 'Elena A', 'Initials': 'EA', 'LastName': 'Pronina', 'Affiliation': 'Shared Core Facilities ""Molecular and Cell Technologies"", V. F. Voino-Yasenetsky Krasnoyarsk State Medical University, 660022 Krasnoyarsk, Russia.'}, {'ForeName': 'Irina V', 'Initials': 'IV', 'LastName': 'Romanova', 'Affiliation': 'Shared Core Facilities ""Molecular and Cell Technologies"", V. F. Voino-Yasenetsky Krasnoyarsk State Medical University, 660022 Krasnoyarsk, Russia.'}, {'ForeName': 'Ekaterina A', 'Initials': 'EA', 'LastName': 'Narodova', 'Affiliation': 'Shared Core Facilities ""Molecular and Cell Technologies"", V. F. Voino-Yasenetsky Krasnoyarsk State Medical University, 660022 Krasnoyarsk, Russia.'}, {'ForeName': 'Regina F', 'Initials': 'RF', 'LastName': 'Nasyrova', 'Affiliation': 'Institute of Personalized Psychiatry and Neurology, V.M. Bekhterev National Medical Research Centre for Psychiatry and Neurology, 192019 Saint Petersburg, Russia.'}, {'ForeName': 'Natalia A', 'Initials': 'NA', 'LastName': 'Shnayder', 'Affiliation': 'Shared Core Facilities ""Molecular and Cell Technologies"", V. F. Voino-Yasenetsky Krasnoyarsk State Medical University, 660022 Krasnoyarsk, Russia.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare10020250']
2391,35207699,Analgesic Effect of Intrathecal Morphine Combined with Low-Dose Bupivacaine on Postoperative Analgesia after Liver Resection: A Randomized Controlled Study.,"Although intrathecal morphine and bupivacaine are increasingly implemented in effective postoperative pain control, there is a lack of consensus on the dosage as high doses of bupivacaine may inadvertently cause unwanted side effects. The purpose of this study was to compare the effects of intrathecal morphine injection and low-dose bupivacaine with morphine injection. In total, 90 patients were divided into 3 groups: (1) sham injection for the control group; (2) morphine 400 mcg for the morphine group (M); and (3) morphine 400 mcg and bupivacaine 5 mg for the morphine and bupivacaine group (M + B). Our primary outcome was time to first rescue analgesic. The VAS (visual analogue scale) pain score was compared until POD (postoperative day)1. Total fentanyl dose was compared until POD2. Side effects were monitored until POD3. Although time to first rescue was significantly shorter in the control group compared to group M and group M + B ( p  < 0.001), both groups (M and M + B) were comparable to each other. There was a significant decrease in the VAS score and total fentanyl administration in group M and group M + B compared to the control group. Pruritus and tingling were more prevalent in the M + B group ( p  = 0.023;  p  = 0.010). The addition of 5 mg bupivacaine may be insufficient in providing further analgesic benefits; however, higher doses may aggravate side effects.",2022,Pruritus and tingling were more prevalent in the M + B group ( p  = 0.023;  p  = 0.010).,"['after Liver Resection', '90 patients']","['morphine 400 mcg for the morphine', 'intrathecal morphine injection and low-dose bupivacaine', 'morphine and bupivacaine', 'morphine 400 mcg and bupivacaine', 'intrathecal morphine', 'morphine injection', 'bupivacaine', 'Intrathecal Morphine Combined with Low-Dose Bupivacaine']","['time to first rescue analgesic', 'Side effects', 'VAS score', 'Pruritus and tingling', 'Postoperative Analgesia', 'VAS (visual analogue scale) pain score']","[{'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C4074518', 'cui_str': 'Morphine Injection [Infumorph]'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",90.0,0.0539793,Pruritus and tingling were more prevalent in the M + B group ( p  = 0.023;  p  = 0.010).,"[{'ForeName': 'MinGi', 'Initials': 'M', 'LastName': 'Ban', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Yong Seon', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Bon-Nyeo', 'Initials': 'BN', 'LastName': 'Koo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul 03722, Korea.'}]",Journal of personalized medicine,['10.3390/jpm12020211']
2392,35207650,Impact of Increased End-Tidal Carbon Dioxide on Continuous Noninvasive Hemoglobin Monitoring during Laparoscopic Gastrectomy: A Randomized Controlled Study.,"The pulse CO-Oximetry allows continuous, noninvasive monitoring of hemoglobin (SpHb). We assessed the impact of increased end-tidal carbon dioxide (EtCO 2 ) on the accuracy and trending ability of SpHb in laparoscopic surgery. Participants ( n  = 64) were randomly allocated to the low carbon dioxide (CO 2 ) group (EtCO 2 : 30-35 mmHg) or the high CO 2  group (EtCO 2 : 40-45 mmHg). The SpHb and laboratory hemoglobin (tHb) were obtained during surgery. The correlation coefficient (r) between SpHb and tHb showed greater tendency in the low CO 2  group (r = 0.68) than in the high CO 2  group (r = 0.43). The bias (precision) was -1.18 (1.09) with a limit of agreement (LOA) of -3.31 to 0.95 in low CO 2  group and -1.02 (1.24) with a LOA of -3.45 to 1.42 in high CO 2  group; they did not differ significantly between the groups ( p  = 0.246). The low CO 2  group showed a high concordance rate of 95.9% and a moderate correlation between ΔSpHb and ΔtHb (r = 0.53). However, the high CO 2  group showed a concordance rate of 77.8% and no correlation between ΔSpHb and ΔtHb (r = 0.11). In conclusion, increased EtCO 2  significantly reduced the trending ability of SpHb during laparoscopic surgery. Caution should be executed when interpreting SpHb values during laparoscopic surgery in patients with hypercapnia.",2022,The correlation coefficient (r) between SpHb and tHb showed greater tendency in the low CO 2  group (r = 0.68) than in the high CO 2  group (r = 0.43).,"['patients with hypercapnia', 'Participants ( n  = 64', 'laparoscopic surgery', 'Laparoscopic Gastrectomy']","['increased end-tidal carbon dioxide (EtCO 2 ', 'low carbon dioxide (CO 2 ', 'Increased End-Tidal Carbon Dioxide']","['concordance rate', 'SpHb and laboratory hemoglobin (tHb']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0860711', 'cui_str': 'Carbon dioxide decreased'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",64.0,0.0688265,The correlation coefficient (r) between SpHb and tHb showed greater tendency in the low CO 2  group (r = 0.68) than in the high CO 2  group (r = 0.43).,"[{'ForeName': 'Ha-Yeon', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Jong-Bum', 'Initials': 'JB', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Sang-Uk', 'Initials': 'SU', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Hye-Sun', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Kyuhyeok', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Ji-Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon 16499, Korea.'}]",Journal of personalized medicine,['10.3390/jpm12020160']
2393,35207633,The Associations of Single Nucleotide Polymorphisms with Risk and Symptoms of Irritable Bowel Syndrome.,"Although several risk single nucleotide polymorphisms (SNPs) have been found to play an important role in etiology of irritable bowel syndrome (IBS), the findings are inconsistent. A descriptive correlational design was used to analyze the baseline data of a randomized controlled trial including participants with IBS and healthy controls (HC). Pain severity and interference, anxiety, sleep, and fatigue were measured using the Brief Pain Inventory (BPI) and patient-reported outcomes measurement information system (PROMIS). Fisher's exact test and multivariate linear regression were used to investigate the associations between IBS risk alleles and IBS symptoms. Participants were predominantly female, white, and had an average age of 21.13 ± 2.42 years. Polymorphisms within  TNFSF15  (rs4263839),  SLC6A4  5-HTTLPR,  HTR3A  (rs1062613), and  OXTR  (rs2254298) were associated with IBS risk, and  TNFSF15  (rs4263839),  COMT  (rs6269),  SLC6A4  5-HTTLPR polymorphisms were associated with pain severity.  TNFSF15  (rs4263839) and  COMT  (rs4680; rs4633) genotypes were associated with sleep disturbance, and the  ADRA1D  SNP rs1556832 was associated with fatigue in both IBS and HC groups. Genotypic differences were associated with IBS risk and symptoms including abdominal pain, sleep disturbance, and fatigue. Further investigation is warranted to reveal the mechanisms by which these genetic variations influence the dynamic nature of IBS symptoms over time.",2022,"COMT  (rs4680; rs4633) genotypes were associated with sleep disturbance, and the  ADRA1D  SNP rs1556832 was associated with fatigue in both IBS and HC groups.","['Participants were predominantly female, white, and had an average age of 21.13 ± 2.42 years', 'participants with IBS and healthy controls (HC']",['TNFSF15  (rs4263839) and'],"['IBS risk and symptoms including abdominal pain, sleep disturbance, and fatigue', 'Pain severity and interference, anxiety, sleep, and fatigue', 'Brief Pain Inventory (BPI) and patient-reported outcomes measurement information system (PROMIS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0762871', 'cui_str': 'TNFSF15 protein, human'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}]",,0.184681,"COMT  (rs4680; rs4633) genotypes were associated with sleep disturbance, and the  ADRA1D  SNP rs1556832 was associated with fatigue in both IBS and HC groups.","[{'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Joochul', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'Starkweather', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Young', 'Affiliation': 'Department of Anesthesiology, University of Kansas Medical Center, Kansas City, KS 66160, USA.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Cong', 'Affiliation': 'School of Nursing, University of Connecticut, Storrs, CT 06269, USA.'}]",Journal of personalized medicine,['10.3390/jpm12020142']
2394,35208013,Physicochemical Properties of Dentine Subjected to Microabrasive Blasting and Its Influence on Bonding to Self-Adhesive Prosthetic Cement in Shear Bond Strength Test: An In Vitro Study.,"The aim of this in vitro study was to assess the influence of microabrasive blasting on the physicochemical properties of dentine and shear bond strength (SBS) of self-adhesive resin cement (Maxcem Elite, Kerr, Orange, CA, USA) bonded to the dentine surface. Ninety cylindrical specimens with exposed dentine of human teeth were prepared and divided into three randomized, parallel sample sets A, B, and C. Groups B and C were subjected to abrasive blasting using a micro-sandblasting device (Microetcher IIa, Danville Materials, Carlsbad, CA, USA) with two gradations of Al 2 O 3  abrasives (Group B, abrasion with a gradation of 50 μm; group C, abrasion with a gradation of 27 μm). SEM imaging, profilometry, chemical composition analysis, contact angle measurements, surface free energy, and SBS tests were performed. The resulting data were statistically analyzed using the Statistica software (ver. 13.3, Tibco Software Inc., Palo Alto, CA, USA). Microabrasive blasting caused changes in surface topography, structural features, and the connection strength between the dentin surface and self-adhesive prosthetic cement. Air microabrasion through the multifactorial positive reorganization of the treated surface of dentine is recommended as a pretreatment method in fixed prosthodontics adhesive cementation protocols.",2022,"Microabrasive blasting caused changes in surface topography, structural features, and the connection strength between the dentin surface and self-adhesive prosthetic cement.","['Shear Bond Strength Test', 'Ninety cylindrical specimens with exposed dentine of human teeth']",[],"['SEM imaging, profilometry, chemical composition analysis, contact angle measurements, surface free energy, and SBS tests']","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]",[],"[{'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0243176', 'cui_str': 'chemical composition'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0338012,"Microabrasive blasting caused changes in surface topography, structural features, and the connection strength between the dentin surface and self-adhesive prosthetic cement.","[{'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Szerszeń', 'Affiliation': 'Department of Prosthodontics, Medical University of Warsaw, 02097 Warsaw, Poland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Higuchi', 'Affiliation': 'Laboratory of Nanostructures, Institute of High Pressure Physics, Polish Academy of Sciences, 01424 Warsaw, Poland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Romelczyk-Baishya', 'Affiliation': 'Faculty of Materials Science and Engineering, Warsaw University of Technology, 02507 Warsaw, Poland.'}, {'ForeName': 'Bartłomiej', 'Initials': 'B', 'LastName': 'Górski', 'Affiliation': 'Department of Periodontal and Oral Mucosa Diseases, Medical University of Warsaw, 02097 Warsaw, Poland.'}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Łojkowski', 'Affiliation': 'Laboratory of Nanostructures, Institute of High Pressure Physics, Polish Academy of Sciences, 01424 Warsaw, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Pakieła', 'Affiliation': 'Faculty of Materials Science and Engineering, Warsaw University of Technology, 02507 Warsaw, Poland.'}, {'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Mierzwińska-Nastalska', 'Affiliation': 'Department of Prosthodontics, Medical University of Warsaw, 02097 Warsaw, Poland.'}]","Materials (Basel, Switzerland)",['10.3390/ma15041476']
2395,35212749,Effect of a Brief Social Contact Video on Transphobia and Depression-Related Stigma Among Adolescents: A Randomized Clinical Trial.,"Importance


Transphobia and stigma remain barriers to seeking mental health care for gender-diverse adolescents.
Objective


To examine the utility of brief social contact-based video interventions of transgender protagonists with depression to reduce transphobia and depression-related stigma and increase treatment-seeking intentions among adolescents in the general population.
Design, Setting, and Participants


During August 2021, a total of 1437 participants were recruited and randomly assigned to 1 of 4 video-based conditions in a 2:2:1:1 ratio: (1) transgender adolescent girls, (2) transgender adolescent boys, (3) cisgender adolescent girls, or (4) cisgender adolescent boys.
Interventions


In each of the approximately 110-second videos, an empowered presenter shared their personal story about coping with depression and reaching out for help.
Main Outcomes and Measures


The primary outcome was the score on the Attitudes Toward Transgender Men and Women (ATTMW) scale. Secondary outcomes were (1) a ""gender thermometer"" rating for warmth in transgender perception, (2) the Depression Stigma Scale (DSS) score, and (3) the General Health-Seeking Questionnaire (GHSQ) score.
Results


Of the 1437 randomized participants, 1098 (76%) completed the postintervention assessment and passed all the validity tests (mean [SD] age, 16.9 [1.2] years; 481 [44%] male; 640 [58%] White). A significant change in attitudes toward transgender youth was found within the intervention group only (mean [SD] ATTMW scores: intervention group, 34.6 [23.1] at baseline to 32.8 [24.2] after intervention; P < .001; control group, 33.5 [23.4] at baseline to 32.4 [24.1] after intervention; P = .01). The mean (SD) total DSS scores decreased significantly across study groups (intervention: 1.3 [3.3]; control: 1.7 [3.3]; P < .001). A significant increase in intention to seek help from a parent was found in the intervention (mean [SD] GHSQ score, 0.2 [1.1]) and control (mean [SD] GHSQ score, 0.3 [1.2]) groups (P < .001), as was a decrease in those not wanting to seek help from anyone (mean [SD] GHSQ score: intervention, 0.2 [1.6], P = .009; control, 0.3 [1.2], P < .001) Secondary analyses revealed significant differences in baseline ATTMW scores and intervention effects between transgender and gender-diverse and cisgender participants and between lesbian, gay, bisexual, or queer (LGBQ) and straight participants (F = 36.7, P < .001) and heterosexual participants (F = 37.0, P < .001). A significant difference was also found in mean (SD) transgender warmth scores from baseline to after intervention between groups (2.6° [13.1°] in the intervention group vs 0.4° [8.3°] in the control group; P < .001).
Conclusions and Relevance


In this randomized clinical trial, brief social contact-based videos proved efficacious in reducing transphobia and depression-related stigma and in increasing treatment-seeking intentions among adolescents in the general population. By personifying, individualizing, and providing face and voice to the experience of transgender youth, other adolescents, especially those who are cisgender and/or of a heterosexual orientation, can gain empathetic insights into the lives of their often marginalized and stigmatized fellow youth.
Trial Registration


ClinicalTrials.gov Identifier: NCT04969003.",2022,"Secondary analyses revealed significant differences in baseline ATTMW scores and intervention effects between transgender and gender-diverse and cisgender participants and between lesbian, gay, bisexual, or queer (LGBQ) and straight participants (F = 36.7, P < .001) and heterosexual participants (F = 37.0, P < .001).","['1437 randomized participants, 1098 (76%) completed the postintervention assessment and passed all the validity tests (mean [SD] age, 16.9 [1.2] years; 481 [44%] male; 640 [58%] White', 'adolescents in the general population', 'Adolescents', 'During August 2021, a total of 1437 participants were recruited and randomly assigned to 1 of 4 video-based conditions in a 2:2:1:1 ratio: (1) transgender adolescent girls, (2) transgender adolescent boys, (3) cisgender adolescent girls, or (4) cisgender adolescent boys', 'gender-diverse adolescents']","['social contact-based video interventions', 'Brief Social Contact Video', 'social contact-based videos']","['mean (SD) transgender warmth scores', 'transphobia and depression-related stigma', 'mean (SD) total DSS scores', 'Transphobia and Depression-Related Stigma', 'attitudes toward transgender youth', 'lesbian, gay, bisexual, or queer (LGBQ', 'score on the Attitudes Toward Transgender Men and Women (ATTMW) scale', 'gender thermometer"" rating for warmth in transgender perception, (2) the Depression Stigma Scale (DSS) score, and (3) the General Health-Seeking Questionnaire (GHSQ) score']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0237101', 'cui_str': 'Social interaction finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0242659', 'cui_str': 'Female homosexual'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0039818', 'cui_str': 'Thermometer'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",1437.0,0.227851,"Secondary analyses revealed significant differences in baseline ATTMW scores and intervention effects between transgender and gender-diverse and cisgender participants and between lesbian, gay, bisexual, or queer (LGBQ) and straight participants (F = 36.7, P < .001) and heterosexual participants (F = 37.0, P < .001).","[{'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Amsalem', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Halloran', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Penque', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Celentano', 'Affiliation': 'Department of Social Work and Marriage and Family Therapy, Southern Connecticut State University, New Haven.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, Connecticut.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.0376']
2396,35213109,Treatment of recurrent minor aphthous stomatitis using diode laser (940 nm).,"BACKGROUND


The exact etiology of recurrent aphthous ulcers (RAUs) is unknown. The management of RAUs is not always straightforward. Ulcers in the mouth (recurrent aphthous stomatitis [RAS]) are very common and may vary in size from very small to very large.
OBJECTIVE


To evaluate reduction in pain intensity and duration of pain relief, reduction in size of ulcer, and duration for healing of ulcer (healing time) in patients with RAS after application of Low-Level Light Amplification by Stimulated Emission of Radiation therapy (LLLT) comparing with topical Anginovag spray medication and control group.
MATERIALS AND METHODS


A total of 21 individuals diagnosed as RAS were divided into three equal groups as follows: Group 1: Minor aphthous ulcer, which was treated by giving LLLT using Diode LASER; Group 2: Minor aphthous ulcer, which was treated by topical Anginovag spray medication.; Group 3: Minor aphthous ulcer, which was treated conservatively with motivation and follow-up.
RESULTS


In this randomized, controlled, clinical study, LLLT using Diode LASER causes reduction in pain intensity due to RAUs, thereby reducing morbidity. There is also reduction in the diameter and healing time of the ulcer as compared to Anginovag spray medication and the control group.
CONCLUSION


Although various treatment modalities have been used and LLLT is not commonly used to treat aphthous ulcers, this study suggests that using LLLT would be a safe and effective treatment modality for RAUs patients.",2022,"In this randomized, controlled, clinical study, LLLT using Diode LASER causes reduction in pain intensity due to RAUs, thereby reducing morbidity.","['patients with RAS after application of Low-Level Light Amplification by Stimulated Emission of Radiation therapy (LLLT) comparing with topical Anginovag spray medication and control group', '21 individuals diagnosed as RAS']","['diode laser', 'LLLT using Diode LASER', 'LLLT']","['diameter and healing time', 'pain intensity and duration of pain relief, reduction in size of ulcer, and duration for healing of ulcer (healing time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]",21.0,0.0476798,"In this randomized, controlled, clinical study, LLLT using Diode LASER causes reduction in pain intensity due to RAUs, thereby reducing morbidity.","[{'ForeName': 'Hussien G H', 'Initials': 'HGH', 'LastName': 'Ghali', 'Affiliation': 'Institute of Laser for Postgraduate Studies, University of Baghdad, Baghdad, Iraq; drnihadkhalawe@gmail.com.'}, {'ForeName': 'Balsam Saadi', 'Initials': 'BS', 'LastName': 'Abdulhamed', 'Affiliation': 'Institute of Laser for Postgraduate Studies, University of Baghdad, Baghdad, Iraq.'}]",Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique,['10.47750/jptcp.2022.864']
2397,35213106,Surgical interventions for inferior turbinate hypertrophy.,"BACKGROUND AND AIM


Nasal obstruction can be induced by various causes; however, inferior turbinate hypertrophy is considered the most frequent cause of this anatomical malfunctioning condition. The current surgical interventional study was focused on comparing the final outcomes of partial inferior turbinectomy (PIT) and powered endoscopic turbinoplasty (PET).
SUBJECTS AND METHODS


The criterion followed for deciding the successfulness of each surgical method was the rate of occurrence of postoperative complications such as bleeding, crustation, and atrophic rhinitis. Fifty patients who suffered from nasal obstruction were randomly divided into two groups: PIT group, with 25 patients, of which 15 (52%) were males and 10 were (48%) females, at an average age of 27.40 ± 7.7 years, and PET group, with 25 patients, out of which 14 (48%) were males and 11 (62%) were females, at an average age of 26.68 ± 6.82 years. The surgical operations were performed at the Department of Otolaryngology, Al-Diwaniyah General Teaching Hospital, Diwaniyah City, Iraq, during the period between March 2015 and March 2020.
RESULTS


The PET group showed significantly lower incidence ( P  < 0.05) of bleeding and crustation than those from the PIT group; however, no significant differences ( P  > 0.05) were observed between PIT and PET in the occurrence of atrophic rhinitis.
CONCLUSION


PET showed promisingly less postoperative complications when compared to PIT.",2022,"The PET group showed significantly lower incidence ( P  < 0.05) of bleeding and crustation than those from the PIT group; however, no significant differences ( P  > 0.05) were observed between PIT and PET in the occurrence of atrophic rhinitis.
","['25 patients, of which 15 (52%) were males and 10 were (48%) females, at an average age of 27.40 ± 7.7 years, and PET group, with 25 patients, out of which 14 (48%) were males and 11 (62%) were females, at an average age of 26.68 ± 6.82 years', 'Fifty patients who suffered from nasal obstruction']",['partial inferior turbinectomy (PIT) and powered endoscopic turbinoplasty (PET'],"['rate of occurrence of postoperative complications such as bleeding, crustation, and atrophic rhinitis', 'postoperative complications', 'bleeding and crustation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C4087115', 'cui_str': 'Turbinoplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0161872', 'cui_str': 'Turbinectomy'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C4087115', 'cui_str': 'Turbinoplasty'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0030105', 'cui_str': 'Ozena'}]",,0.0197893,"The PET group showed significantly lower incidence ( P  < 0.05) of bleeding and crustation than those from the PIT group; however, no significant differences ( P  > 0.05) were observed between PIT and PET in the occurrence of atrophic rhinitis.
","[{'ForeName': 'Ali Abd-Almer', 'Initials': 'AA', 'LastName': 'Jwad', 'Affiliation': 'Department of Otolaryngology, University of AL-Qadisiyah, College of Medicine, Iraq; ali.jwad@qu.edu.iq.'}, {'ForeName': 'Wasam A', 'Initials': 'WA', 'LastName': 'Albualih', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Al-Diwaniyah General Teaching Hospital, Diwaniyah City, Iraq.'}, {'ForeName': 'Abbas Kalaf', 'Initials': 'AK', 'LastName': 'Mahdi', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Al-Diwaniyah General Teaching Hospital, Diwaniyah City, Iraq.'}]",Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique,['10.47750/jptcp.2022.861']
2398,34893397,"Effect of a backboard on chest compression quality during in-hospital adult cardiopulmonary resuscitation: A randomised, single-blind, controlled trial using a manikin model.","INTRODUCTION


Chest compression quality during in-hospital resuscitation is often suboptimal on a soft surface. Scientific evidence regarding the effectiveness of a backboard is scarce. This single-blinded manikin study evaluated the effect of a backboard on compression depth, rate and chest recoil performed by nurses. Sex, BMI, age and clinical department were considered as potential predictors.
METHODS


Using self-learning, nurses were retrained to achieve a minimal combined compression score at baseline. This combined score consisted of ≥70% compressions with depth 50-60 mm, ≥70% compressions with complete release (≤5mm) and a mean compression rate of 100-120 bpm. Subsequently, nurses were allocated to a backboard or control group and performed a two-minute cardiopulmonary resuscitation test. The main outcome measure was the difference in proportion of participants achieving a combined compression score of ≥70%.
RESULTS


In total 278 nurses were retrained, 158 nurses dropped out and 120 were allocated to the backboard (n = 61) or control group (n = 59). The proportion of participants achieving a combined compression score of ≥70% was not significantly different (p = 0.475) and suboptimal in both groups: backboard group 47.5% (backboard) versus 41.0% (control). Older age (≥51 years) was associated with a lower probability of achieving a combined compression score >70% [OR = 0.133; 95% confidence interval (CI), 0.037-0.479; p = 0.002].
CONCLUSION


Using a backboard did not significantly improve compression quality in our study. Important decay of compression skills was observed in both groups, highlighting the importance of frequent retraining, particularly in some age groups.",2022,The proportion of participants achieving a combined compression score of ≥70% was not significantly different (p = 0.475) and suboptimal in both groups: backboard group 47.5% (backboard) versus 41.0% (control).,"['In total 278 nurses were retrained, 158 nurses dropped out and 120 were allocated to the', 'hospital adult cardiopulmonary resuscitation', 'Older age (≥51\xa0years']",['backboard'],"['proportion of participants achieving a combined compression score', 'compression quality', 'proportion of participants achieving a combined compression score of ≥70', 'chest compression quality', 'compression depth, rate and chest recoil', 'compression skills', 'mean compression rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0183440', 'cui_str': 'Spine board'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",278.0,0.0727163,The proportion of participants achieving a combined compression score of ≥70% was not significantly different (p = 0.475) and suboptimal in both groups: backboard group 47.5% (backboard) versus 41.0% (control).,"[{'ForeName': 'Zara', 'Initials': 'Z', 'LastName': 'Cuvelier', 'Affiliation': 'Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, Corneel Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Houthoofdt', 'Affiliation': 'Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, Corneel Heymanslaan 10, 9000 Ghent, Belgium. Electronic address: rubenhouthoofdt@gmail.com.'}, {'ForeName': 'Brecht', 'Initials': 'B', 'LastName': 'Serraes', 'Affiliation': 'Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, Corneel Heymanslaan 10, 9000 Ghent, Belgium; Nursing and Paramedical Department, AZ Nikolaas (General Hospital), Moerlandstraat 1, 9100 Sint-Niklaas, Belgium; Executive Board of the Flemish Society for Critical Care Nurses, Ghent, Belgium.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Haentjens', 'Affiliation': 'Emergency Department, AZ Nikolaas (General Hospital), Moerlandstraat 1, 9100 Sint-Niklaas, Belgium.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Blot', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Corneel Heymanslaan 10, 9000 Ghent, Belgium; Burns, Trauma, and Critical Care Research Centre, Faculty of Medicine, The University of Queensland, Australia; Executive Board of the Flemish Society for Critical Care Nurses, Ghent, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Mpotos', 'Affiliation': 'Emergency Department, St. Lucas General Hospital, Groenebriel 1, 9000 Ghent, Belgium; Department of Fundamental and Applied Medical Sciences, Ghent University, Corneel Heymanslaan 10, 9000 Ghent, Belgium.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2021.103164']
2399,34874061,"A lay navigator-led, early palliative care intervention for African American and rural family caregivers of individuals with advanced cancer (Project Cornerstone): Results of a pilot randomized trial.","BACKGROUND


The objective of this study was to assess the feasibility, acceptability, and potential efficacy of ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone-a lay navigator-led, early palliative care telehealth intervention for African American/Black and/or rural-dwelling family caregivers of individuals with advanced cancer (ClinicalTrials.gov identifier NCT03464188).
METHODS


This was a pilot randomized trial (November 2019 to March 2021). Family caregivers of patients with newly diagnosed, stage III/IV, solid-tumor cancers were randomized to receive either an intervention or usual care. Intervention caregivers were paired with a specially trained lay navigator who delivered 6 weekly, 20-minute to 60-minute telehealth coaching sessions plus monthly follow-up for 24 weeks, reviewing skills in stress management, self-care, getting help, staying organized, and future planning. Feasibility was assessed according to the completion of sessions and questionnaires (predefined as a completion rate ≥80%). Acceptability was determined through intervention participants' ratings of their likelihood of recommending the intervention. Measures of caregiver distress and quality of life were collected at 8 and 24 weeks.
RESULTS


Sixty-three family caregivers were randomized (usual care, n = 32; intervention, n = 31). Caregivers completed 65% of intervention sessions and 87% of questionnaires. Average ratings for recommending the program were 9.4, from 1 (not at all likely) to 10 (extremely likely). Over 24 weeks, the mean ± SE Hospital Anxiety and Depression Scale score improved by 0.30 ± 1.44 points in the intervention group and worsened by 1.99 ± 1.39 points in the usual care group (difference, -2.29; Cohen d, -0.32). The mean between-group difference scores in caregiver quality of life was -1.56 (usual care - intervention; d, -0.07). Similar outcome results were observed for patient participants.
CONCLUSIONS


The authors piloted ENABLE Cornerstone, an intervention for African American and rural-dwelling advanced cancer family caregivers. The acceptability of the intervention and data collection rates were high, and the preliminary efficacy for caregiver distress was promising.
LAY SUMMARY


To date, very few programs have been developed to support under-resourced cancer family caregivers. To address this need, the authors successfully pilot tested an early palliative care program, called Educate, Nurture, Advise, Before Life Ends (ENABLE) Cornerstone, for African American and rural family caregivers of individuals with advanced cancer. Cornerstone is led by specially trained lay people and involves a series of weekly phone sessions focused on coaching caregivers to manage stress and provide effective support to patients with cancer. The authors are now testing Cornerstone in a larger trial. If the program demonstrates benefit, it may yield a model of caregiver support that could be widely implemented.",2022,"Over 24 weeks, the mean ± SE Hospital Anxiety and Depression Scale score improved by 0.30 ± 1.44 points in the intervention group and worsened by 1.99 ± 1.39 points in the usual care group (difference, -2.29; Cohen d, -0.32).","['Sixty-three family caregivers', 'African American/Black and/or rural-dwelling family caregivers of individuals with advanced cancer', 'African American and rural-dwelling advanced cancer family caregivers', 'African American and rural family caregivers of individuals with advanced cancer', 'Family caregivers of patients with newly diagnosed, stage III/IV, solid-tumor cancers', 'African American and rural family caregivers of individuals with advanced cancer (Project Cornerstone', 'patients with cancer']","['palliative care intervention', 'intervention or usual care', 'telehealth coaching sessions plus monthly follow-up for 24 weeks, reviewing skills in stress management, self-care, getting help, staying organized, and future planning', 'palliative care telehealth intervention']","['caregiver quality of life', 'Acceptability', 'caregiver distress and quality of life', 'mean ± SE Hospital Anxiety and Depression Scale score']","[{'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0491091,"Over 24 weeks, the mean ± SE Hospital Anxiety and Depression Scale score improved by 0.30 ± 1.44 points in the intervention group and worsened by 1.99 ± 1.39 points in the usual care group (difference, -2.29; Cohen d, -0.32).","[{'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (UAB), Birmingham, Alabama.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (UAB), Birmingham, Alabama.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Taylor', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (UAB), Birmingham, Alabama.'}, {'ForeName': 'Chinara', 'Initials': 'C', 'LastName': 'Dosse', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (UAB), Birmingham, Alabama.'}, {'ForeName': 'Avery C', 'Initials': 'AC', 'LastName': 'Bechthold', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (UAB), Birmingham, Alabama.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Currie', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (UAB), Birmingham, Alabama.'}, {'ForeName': 'Rhiannon D', 'Initials': 'RD', 'LastName': 'Reed', 'Affiliation': 'Comprehensive Transplant Institute, UAB, Birmingham, Alabama.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Harrell', 'Affiliation': 'Department of Psychology, University of Alabama, Tuscaloosa, Alabama.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Engler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (UAB), Birmingham, Alabama.'}, {'ForeName': 'Deborah B', 'Initials': 'DB', 'LastName': 'Ejem', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (UAB), Birmingham, Alabama.'}, {'ForeName': 'Nataliya V', 'Initials': 'NV', 'LastName': 'Ivankova', 'Affiliation': 'Department of Health Services Administration, UAB, Birmingham, Alabama.'}, {'ForeName': 'Michelle Y', 'Initials': 'MY', 'LastName': 'Martin', 'Affiliation': 'Department of Preventive Medicine, Center for Innovation in Health Equity Research, University of Tennessee Health Science Center, Memphis, Tennessee.'}, {'ForeName': 'Gabrielle B', 'Initials': 'GB', 'LastName': 'Rocque', 'Affiliation': 'Division of Geriatrics, Gerontology, and Palliative Care, UAB Department of Medicine, Birmingham, Alabama.'}, {'ForeName': 'Grant R', 'Initials': 'GR', 'LastName': 'Williams', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, UAB, Birmingham, Alabama.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Bakitas', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham (UAB), Birmingham, Alabama.'}]",Cancer,['10.1002/cncr.34044']
2400,35213293,"Study protocol for the Respond to Prevent Study: a multi-state randomized controlled trial to improve provision of naloxone, buprenorphine and nonprescription syringes in community pharmacies.","Access to the opioid antidote naloxone is a critical component of addressing the opioid crisis. Naloxone is a population-level prevention intervention associated with substantial reductions in overdose mortality and reduction of nonfatal overdose. Pharmacies' pivotal role in dispensing medications like buprenorphine for the treatment of opioid use disorder and selling nonprescription syringes places them at the crossroads of opioid access and risk mitigation methods like naloxone provision. Testing ways to optimize pharmacy-based naloxone provision will be key as the country expands the implementation of naloxone through the medical system. In the Respond to Prevent Study, we conducted a large, practical study of a pharmacy-focused intervention in a sample of Washington, Oregon, Massachusetts and New Hampshire community chain pharmacies to increase naloxone dispensing and improve opioid safety. The intervention integrated two evidence-based educational toolkits and streamlined materials to enhance the focus on naloxone policy, stigma reduction, and patient communications around naloxone, nonprescription syringes and buprenorphine access. The real-world study implemented a stepped wedge, clustered randomized trial design across 175 community chain pharmacies to evaluate the effectiveness of the Respond to Prevent intervention in increasing: (a) pharmacy based naloxone distribution rates, naloxone-related patient engagement, and pharmacist and technicians' attitudes, knowledge, perceived behavioral control and self-efficacy toward naloxone; and (b) pharmacy nonprescription syringe sales, and pharmacist and technicians' attitudes, knowledge, perceived behavioral control and self-efficacy toward dispensing buprenorphine for opioid use disorder (secondary outcomes). This commentary provides a brief narrative about the study and presents insights on the design and adaptations to our study protocol, including those adopted during the unprecedented COVID-19 pandemic further compounded by Western wildfires in 2020.",2022,Pharmacies' pivotal role in dispensing medications like buprenorphine for the treatment of opioid use disorder and selling nonprescription syringes places them at the crossroads of opioid access and risk mitigation methods like naloxone provision.,"['community pharmacies', '175 community chain pharmacies']","['buprenorphine', 'naloxone, nonprescription syringes and buprenorphine access', 'naloxone, buprenorphine and nonprescription syringes', 'naloxone', 'Naloxone', 'opioid antidote naloxone']","['overdose mortality and reduction of nonfatal overdose', 'opioid safety']","[{'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003295', 'cui_str': 'Antidote'}]","[{'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.146255,Pharmacies' pivotal role in dispensing medications like buprenorphine for the treatment of opioid use disorder and selling nonprescription syringes places them at the crossroads of opioid access and risk mitigation methods like naloxone provision.,"[{'ForeName': 'Traci C', 'Initials': 'TC', 'LastName': 'Green', 'Affiliation': 'Opioid Policy Research Collaborative, The Heller School for Social Policy and Management, Brandeis University, Waltham, Massachusetts, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bratberg', 'Affiliation': 'University of Rhode Island College of Pharmacy, Kingston, Rhode Island, USA.'}, {'ForeName': 'Adriane N', 'Initials': 'AN', 'LastName': 'Irwin', 'Affiliation': 'Oregon State University College of Pharmacy, Corvallis, Oregon, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Boggis', 'Affiliation': 'Opioid Policy Research Collaborative, The Heller School for Social Policy and Management, Brandeis University, Waltham, Massachusetts, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Gray', 'Affiliation': 'Comagine Health, Portland, Oregon, USA.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Leichtling', 'Affiliation': 'Comagine Health, Portland, Oregon, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Bolivar', 'Affiliation': 'Opioid Policy Research Collaborative, The Heller School for Social Policy and Management, Brandeis University, Waltham, Massachusetts, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Floyd', 'Affiliation': 'University of Washington, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Al-Jammali', 'Affiliation': 'Oregon State University College of Pharmacy, Corvallis, Oregon, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Arnold', 'Affiliation': 'Washington State Pharmacy Association, Renton, Washington, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Hansen', 'Affiliation': 'University of Washington, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hartung', 'Affiliation': 'Oregon State University College of Pharmacy, Corvallis, Oregon, USA.'}]",Substance abuse,['10.1080/08897077.2021.2010162']
2401,35213879,Apixaban: Alternative Anticoagulation for HeartMate 3 Ventricular Assist Device.,"Patients with left ventricular assist devices currently require long-term anticoagulation with warfarin. Warfarin requires frequent blood tests and is associated with adverse events when not in the therapeutic range. Apixaban is a possible alternative that is potentially better for compliance and requires no additional testing. The purpose of this study was to compare adverse events in patients with a HeartMate 3 LVAD receiving apixaban versus warfarin. Thirty-five patients underwent HM3 implantation between January 01, 2016 to January 31, 2021. The groups compared were apixaban (n = 15, 43%) and warfarin (n = 20, 57%). All patients received 325 mg aspirin daily. Stroke, bleeding, and death were identified as primary outcomes after LVAD implant. Univariate nonparametric statistical analysis was performed. The median duration of treatment with apixaban was 148 days (37-606 days). The groups were comparable in terms of age (56 vs. 54 years), gender (male, 85% vs. 75%), and renal function (Cr 1.5 vs. 1.4). The apixaban group had significantly higher mean pulmonary artery pressure (41 vs. 34, p = 0.03) and there were more (p < 0.05) ischemic cardiomyopathy and INTERMACS profile >3 in the warfarin group. At 6 months, thrombotic complications and death were not different between the groups. The two deaths in the apixaban group were from right heart failure. The apixaban group had clinically lower rates of bleeding complications (5% vs. 30%). The adverse events of bleeding, stroke, and death were similar in HM3 patients receiving warfarin or apixaban. Apixaban may be a safe alternative anticoagulant therapy in HM 3 LVAD patients.",2022,"The apixaban group had significantly higher mean pulmonary artery pressure (41 vs. 34, p = 0.03) and there were more (p < 0.05) ischemic cardiomyopathy and INTERMACS profile >3 in the warfarin group.","['patients with a HeartMate 3 LVAD receiving', 'Thirty-five patients underwent HM3 implantation between January 01, 2016 to January 31, 2021', 'Patients with left ventricular assist devices currently require long-term anticoagulation with', 'HM 3 LVAD patients', 'age (56 vs. 54 years), gender (male, 85% vs. 75%), and renal function (Cr 1.5 vs. 1.4']","['apixaban versus warfarin', 'Warfarin', 'aspirin', 'apixaban', 'warfarin or apixaban', 'Apixaban', 'warfarin']","['bleeding complications', 'adverse events of bleeding, stroke, and death', 'thrombotic complications and death', 'Stroke, bleeding, and death', 'mean pulmonary artery pressure', 'adverse events', 'right heart failure', 'median duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4517503', 'cui_str': '1.4'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0235527', 'cui_str': 'Right heart failure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0424641,"The apixaban group had significantly higher mean pulmonary artery pressure (41 vs. 34, p = 0.03) and there were more (p < 0.05) ischemic cardiomyopathy and INTERMACS profile >3 in the warfarin group.","[{'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Whitehouse', 'Affiliation': 'From the Division of Cardiology, Department of Cardiovascular and Thoracic Surgery, University of Louisville, Kentucky.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Avula', 'Affiliation': ''}, {'ForeName': 'Tanvir', 'Initials': 'T', 'LastName': 'Kahlon', 'Affiliation': ''}, {'ForeName': 'Devan', 'Initials': 'D', 'LastName': 'Costelle', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dunbar-Matos', 'Affiliation': ''}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Pahwa', 'Affiliation': ''}, {'ForeName': 'Jaimin R', 'Initials': 'JR', 'LastName': 'Trivedi', 'Affiliation': ''}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Slaughter', 'Affiliation': ''}]",ASAIO journal (American Society for Artificial Internal Organs : 1992),['10.1097/MAT.0000000000001650']
2402,35214209,Virtual Reality Systems as an Orientation Aid for People Who Are Blind to Acquire New Spatial Information.,"This research aims to examine the impact of virtual environments interface on the exploration process, construction of cognitive maps, and performance of orientation tasks in real spaces by users who are blind. The study compared interaction with identical spaces using different systems: BlindAid, Virtual Cane, and real space. These two virtual systems include user-interface action commands that convey unique abilities and activities to users who are blind and that operate only in these VR systems and not in real space (e.g., teleporting the user's avatar or pointing at a virtual object to receive information). This research included 15 participants who are blind, divided into three groups: a control group and two experimental groups. Varied tasks (exploration and orientation) were used in two virtual environments and in real spaces, with both qualitative and quantitative methodologies. The results show that the participants were able to explore, construct a cognitive map, and perform orientation tasks. Participants in both virtual systems used these action commands during their exploration process: all participants used the teleport action command to move their avatar to the starting point and all Virtual Cane participants explored the environment mainly by using the look-around mode, which enabled them to collect spatial information in a way that influenced their ability to construct a cognitive map based on a map model.",2022,"Participants in both virtual systems used these action commands during their exploration process: all participants used the teleport action command to move their avatar to the starting point and all Virtual Cane participants explored the environment mainly by using the look-around mode, which enabled them to collect spatial information in a way that influenced their ability to construct a cognitive map based on a map model.","['People', '15 participants who are blind', 'real spaces by users who are blind']",['teleport action command to move their avatar to the starting point and all Virtual Cane participants explored the environment mainly by using the look-around mode'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]","[{'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0006856', 'cui_str': 'Cane'}]",[],15.0,0.0356747,"Participants in both virtual systems used these action commands during their exploration process: all participants used the teleport action command to move their avatar to the starting point and all Virtual Cane participants explored the environment mainly by using the look-around mode, which enabled them to collect spatial information in a way that influenced their ability to construct a cognitive map based on a map model.","[{'ForeName': 'Orly', 'Initials': 'O', 'LastName': 'Lahav', 'Affiliation': 'The Constantiner School of Education, Tel Aviv University, Tel Aviv 6997801, Israel.'}]","Sensors (Basel, Switzerland)",['10.3390/s22041307']
2403,35214712,"Safety, Immunogenicity and Lot-to-Lot Consistency of Sabin-Strain Inactivated Poliovirus Vaccine in 2-Month-Old Infants: A Double-Blind, Randomized Phase III Trial.","BACKGROUND


The Sabin-strain-based inactivated poliovirus vaccine (sIPV) plays an important role in poliomyelitis eradication in developing countries. As part of the phase III clinical development program, this study aimed to evaluate the safety, immunogenicity and lot-to-lot consistency of the sIPV in 2-month-old infants.
METHOD


We conducted a phase III, randomized, double-blind, positive-controlled trial in which 1300 healthy infants were randomly assigned to four groups in a 1:1:1:1 ratio to receive one of the three lots of the sIPV or the control IPV at 2, 3 and 4 months of age. Serum samples were collected before the first dose and 30 days after the third dose of vaccination to assess the immunogenicity. Solicited local and systemic reactions were recorded within 7 days and unsolicited adverse events within 30 days after each vaccination.
RESULTS


Of the 1300 randomized infants, 1190 infants completed the study and were included in the per-protocol population. The seroconversion rates in the three lots of the sIPV were 95.67%, 97.03% and 95.59%, respectively, for type 1; 94.33%, 93.73% and 92.88%, respectively, for type 2; and 98.67%, 99.67% and 99.32%, respectively, for type 3. The ratios of GMTs for poliovirus types 1, 2 and 3 of each pair of lots were all between 0.67 and 1.50, therefore meeting the predefined immunological equivalence criteria. For the seroconversion rate of poliovirus types 1, 2 and 3, the pooled sIPV group was non-inferior to the IPV group. The incidence of solicited and unsolicited adverse reactions (ARs) was similar in the pooled sIPV lots and the IPV group, and most of them were mild to moderate in severity. Non-vaccine-related serious adverse events (SAEs) were reported.
CONCLUSIONS


Three consecutive lots of sIPV demonstrated robust and consistent immunogenicity. The safety and tolerability of the sIPV was acceptable and similar to that of the IPV.",2022,"The incidence of solicited and unsolicited adverse reactions (ARs) was similar in the pooled sIPV lots and the IPV group, and most of them were mild to moderate in severity.","['2-Month-Old Infants', '2-month-old infants', '1300 randomized infants', '1190 infants completed the study and were included in the per-protocol population', '1300 healthy infants']","['Sabin-Strain Inactivated Poliovirus Vaccine', 'sIPV or the control IPV', 'Sabin-strain-based inactivated poliovirus vaccine (sIPV']","['Solicited local and systemic reactions', 'Safety, Immunogenicity', 'incidence of solicited and unsolicited adverse reactions (ARs', 'safety and tolerability', 'seroconversion rates']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",1300.0,0.32846,"The incidence of solicited and unsolicited adverse reactions (ARs) was similar in the pooled sIPV lots and the IPV group, and most of them were mild to moderate in severity.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Vaccine Clinical Research Center, Yunnan Provincial Center for Disease Control and Prevention, Kunming 650034, China.'}, {'ForeName': 'Zhifang', 'Initials': 'Z', 'LastName': 'Ying', 'Affiliation': 'Respiratory Virus Vaccine Department, Biological Product Institute, National Institutes for Food and Drug Control, Beijing 100050, China.'}, {'ForeName': 'Yanxiang', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Vaccine Clinical Research Center, Yunnan Provincial Center for Disease Control and Prevention, Kunming 650034, China.'}, {'ForeName': 'Taotao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Clinical Research Department, Sinovac Biotech Co., Ltd., Beijing 100089, China.'}, {'ForeName': 'Dinggu', 'Initials': 'D', 'LastName': 'Qian', 'Affiliation': 'Vaccine Clinical Research Project Office, Qiubei County Center for Disease Control and Prevention, Wenshan Zhuang and Miao Autonomous Prefecture 663299, China.'}, {'ForeName': 'Weixiao', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Clinical Research Department, Sinovac Biotech Co., Ltd., Beijing 100089, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Vaccine Clinical Research Project Office, Mile County Center for Disease Control and Prevention, Honghe Hani and Yi Autonomous Prefecture 652399, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Statistics Department, Beijing Key Tech Statistical Consulting Co., Ltd., Beijing 100025, China.'}, {'ForeName': 'Xingyan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Division of Acute Infectious Disease Control and Prevention, Yanshan County Center for Disease Control and Prevention, Wenshan Zhuang and Miao Autonomous Prefecture 663299, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Clinical Research Department, Sinovac Biotech Co., Ltd., Beijing 100089, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lei', 'Affiliation': 'Immunization Program Division, Gejiu County Center for Disease Control and Prevention, Honghe Hani and Yi Autonomous Prefecture 661099, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Quality Assurance Department, Sinovac Biotech Co., Ltd., Beijing 100089, China.'}, {'ForeName': 'Deyu', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'R&D Department, Sinovac Life Sciences Co., Ltd., Beijing 102629, China.'}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Respiratory Virus Vaccine Department, Biological Product Institute, National Institutes for Food and Drug Control, Beijing 100050, China.'}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Vaccine Clinical Research Center, Yunnan Provincial Center for Disease Control and Prevention, Kunming 650034, China.'}]",Vaccines,['10.3390/vaccines10020254']
2404,35214654,Benefits of Using Dapsone in Patients Hospitalized with COVID-19.,"Since the start of the SARS-CoV-2 pandemic, refractory and relentless hypoxia as a consequence of exuberant lung inflammation and parenchymal damage remains the main cause of death. We have earlier reported results of the addition of dapsone in this population to the standard of care. We now report a further chart review of discharge outcomes among patients hospitalized for COVID-19. The 2 × 2 table analysis showed a lower risk of death or discharge to LTAC (Long term acute care) (RR = 0.52, 95% CI: 0.32 to 0.84) and a higher chance of discharge home (RR = 2.7, 95% CI: 1.2 to 5.9) among patients receiving dapsone compared to those receiving the usual standard of care. A larger, blinded randomized trial should be carried out urgently to determine if dapsone indeed improves outcomes in COVID-19.",2022,"The 2 × 2 table analysis showed a lower risk of death or discharge to LTAC (Long term acute care) (RR = 0.52, 95% CI: 0.32 to 0.84) and a higher chance of discharge home (RR = 2.7, 95% CI: 1.2 to 5.9) among patients receiving dapsone compared to those receiving the usual standard of care.","['Patients Hospitalized with COVID-19', 'patients hospitalized for COVID-19']","['dapsone', 'Dapsone']","['lower risk of death or discharge to LTAC', 'chance of discharge home']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0010980', 'cui_str': 'Dapsone'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",,0.40315,"The 2 × 2 table analysis showed a lower risk of death or discharge to LTAC (Long term acute care) (RR = 0.52, 95% CI: 0.32 to 0.84) and a higher chance of discharge home (RR = 2.7, 95% CI: 1.2 to 5.9) among patients receiving dapsone compared to those receiving the usual standard of care.","[{'ForeName': 'Badar A', 'Initials': 'BA', 'LastName': 'Kanwar', 'Affiliation': 'Department of Intensive Care Unit and Neonatal Intensive Care, Hunt Regional Hospital, Greenville, TX 75401, USA.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Khattak', 'Affiliation': 'Department of Intensive Care Unit and Neonatal Intensive Care, Hunt Regional Hospital, Greenville, TX 75401, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Balentine', 'Affiliation': 'Department of Intensive Care Unit and Neonatal Intensive Care, Hunt Regional Hospital, Greenville, TX 75401, USA.'}, {'ForeName': 'Jong Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Science and Research Center, Seoul National University College of Medicine, Seoul 03080, Korea.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Kast', 'Affiliation': 'IIAIGC Study Center, Burlington, VT 05408, USA.'}]",Vaccines,['10.3390/vaccines10020195']
2405,35214634,Tipping the Fencesitters-The Impact of a Minimal Intervention Enhanced with Biological Facts on Swiss Student Teachers' Perception of HPV Vaccination Safety.,"Not much is known about the role of scientific knowledge in vaccination decision making. This study is based on previous findings that the concern about the human papillomavirus (HPV) agent mutating back to a virulent HPV was common among Swiss student teachers and turned out to be one factor of vaccine hesitancy. The study investigate the impact of a standard public health brochure describing the effectiveness, safety, and importance of HPV vaccination on young student teachers, and the additional effect of supplementing the standard brochure with biological arguments against the mutation concerns. It uses a pre-posttest design and assigns participants randomly to two groups, one reviewing a standard public health brochure, the other the same brochure enhanced with additional biological information. Participants in both groups showed a significant positive change in their beliefs about vaccination safety, effectiveness, and importance in preventing cervical cancer. Post hoc analysis showed significant safety beliefs gain for the subgroup of participants who received the biology-enhanced text and held moderate, rather than high or low, pretest safety beliefs-the so-called fencesitters. We conclude that these fencesitters may particularly profit from even minimal (biologically supplemented) interventions, an effect that should receive more attention in future research.",2022,"Participants in both groups showed a significant positive change in their beliefs about vaccination safety, effectiveness, and importance in preventing cervical cancer.","['Swiss student teachers', 'Swiss Student Teachers', 'young student teachers']","['HPV vaccination', 'standard public health brochure', 'standard public health brochure, the other the same brochure enhanced with additional biological information']","['beliefs about vaccination safety, effectiveness, and importance in preventing cervical cancer', 'safety beliefs gain']","[{'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}]",,0.0548272,"Participants in both groups showed a significant positive change in their beliefs about vaccination safety, effectiveness, and importance in preventing cervical cancer.","[{'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Keselman', 'Affiliation': 'Office of Engagement and Training, National Library of Medicine, National Institutes of Health, Bethesda, MD 20894, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Zeyer', 'Affiliation': 'Institute for Education in Science and Social Studies, University of Education Lucerne, 6003 Lucerne, Switzerland.'}]",Vaccines,['10.3390/vaccines10020175']
2406,35214619,Antibody Response of Combination of BNT162b2 and CoronaVac Platforms of COVID-19 Vaccines against Omicron Variant.,"By vaccinating SARS-CoV-2 naïve individuals who have already received two doses of COVID-19 vaccines, we aimed to investigate whether a heterologous prime-boost strategy, using vaccines of different platforms as the booster dose, can enhance the immune response against SARS-CoV-2 virus variants. Participants were assigned into four groups, each receiving different combination of vaccinations: two doses of BNT162b2 followed by one dose of BNT162b2 booster (B-B-B); Combination of BNT162b2 (first dose) and CoronaVac (second dose) followed by one dose of BNT162b2 booster (B-C-B); two doses of CoronaVac followed by one dose of CoronaVac booster (C-C-C); two doses of CoronaVac followed by one dose of BNT162b2 booster (C-C-B). The neutralizing antibody in sera against the virus was determined with live virus microneutralization assay (vMN). The B-B-B group and C-C-B group demonstrated significantly higher immunogenicity against SARS-CoV-2 Wild type (WT), Beta variant (BV) and Delta variant (DV). In addition, the B-B-B group and C-C-B group showed reduced but existing protection against Omicron variant (OV). Moreover, A persistent rise in vMN titre against OV was observed 3 days after booster dose. Regarding safety, a heterologous prime-boost vaccine strategy is well tolerated. In this study, it was demonstrated that using vaccines of different platforms as booster dose can enhance protection against SARS-CoV-2 variants, offering potent neutralizing activity against wild-type virus (WT), Beta variant (BV), Delta variant (DV) and some protection against the Omicron variant (OV). In addition, a booster mRNA vaccine results in a more potent immune response than inactivated vaccine regardless of which platform was used for prime doses.",2022,"The B-B-B group and C-C-B group demonstrated significantly higher immunogenicity against SARS-CoV-2 Wild type (WT),",[],[],"['Beta variant (BV) and Delta variant (DV', 'neutralizing activity against wild-type virus (WT), Beta variant (BV), Delta variant (DV', 'immunogenicity against SARS-CoV-2 Wild type (WT', 'existing protection against Omicron variant (OV', 'vMN titre against OV']",[],[],"[{'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0449572', 'cui_str': 'Virus type'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1720076', 'cui_str': 'Omicron'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",,0.0200398,"The B-B-B group and C-C-B group demonstrated significantly higher immunogenicity against SARS-CoV-2 Wild type (WT),","[{'ForeName': 'Ka-Wa', 'Initials': 'KW', 'LastName': 'Khong', 'Affiliation': 'Department of Medicine, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Danlei', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ka-Yi', 'Initials': 'KY', 'LastName': 'Leung', 'Affiliation': 'Department of Microbiology, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Department of Microbiology, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Hoi-Yan', 'Initials': 'HY', 'LastName': 'Lam', 'Affiliation': 'Department of Microbiology, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Linlei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Microbiology, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Pui-Chun', 'Initials': 'PC', 'LastName': 'Chan', 'Affiliation': 'Department of Microbiology, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ho-Ming', 'Initials': 'HM', 'LastName': 'Lam', 'Affiliation': 'Department of Medicine, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Medicine, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ruiqi', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yujing', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Medicine, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Kelvin Kai-Wang', 'Initials': 'KK', 'LastName': 'To', 'Affiliation': 'Department of Microbiology, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Honglin', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Microbiology, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Kwok-Yung', 'Initials': 'KY', 'LastName': 'Yuen', 'Affiliation': 'Department of Microbiology, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Kwok-Hung', 'Initials': 'KH', 'LastName': 'Chan', 'Affiliation': 'Department of Microbiology, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ivan Fan-Ngai', 'Initials': 'IF', 'LastName': 'Hung', 'Affiliation': 'Department of Medicine, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.'}]",Vaccines,['10.3390/vaccines10020160']
2407,35214526,The Immediate Carryover Effects of Peroneal Functional Electrical Stimulation Differ between People with and without Chronic Ankle Instability.,"Chronic ankle instability (CAI) is a common condition that may develop after an ankle sprain. Compared with healthy individuals, those with CAI demonstrate excessive ankle inversion and increased peroneal electromyography (EMG) activity throughout the stance phase of gait, which may put them at greater risk for re-injury. Functional electrical stimulation (FES) of targeted muscles may provide benefits as a treatment modality to stimulate immediate adaptation of the neuromuscular system. The present study investigated the effect of a single, 10 min peroneal FES session on ankle kinematics and peroneal EMG activity in individuals with ( n  = 24) or without ( n  = 24) CAI. There were no significant differences in ankle kinematics between the groups before the intervention. However, after the intervention, healthy controls demonstrated significantly less ankle inversion between 0-9% ( p  = 0.009) and 82-87% ( p  = 0.011) of the stance phase. Furthermore, a significant within-group difference was observed only in the control group, demonstrating increased ankle eversion between 0-7% ( p  = 0.011) and 67-81% ( p  = 0.006) of the stance phase after the intervention. Peroneal EMG activity did not differ between groups or measurements. These findings, which demonstrate that peroneal FES can induce ankle kinematics adaptations during gait, can help to develop future interventions for people with CAI.",2022,"However, after the intervention, healthy controls demonstrated significantly less ankle inversion between 0-9% ( p  = 0.009) and 82-87% ( p  = 0.011) of the stance phase.","['Chronic ankle instability (CAI', 'people with CAI', 'People with and without Chronic Ankle Instability', 'individuals with ( n  = 24) or without ( n  = 24) CAI']","['Functional electrical stimulation (FES', 'Peroneal Functional Electrical Stimulation', 'peroneal FES session']","['ankle kinematics and peroneal EMG activity', 'Peroneal EMG activity', 'ankle eversion', 'ankle kinematics', 'ankle inversion', 'peroneal electromyography (EMG) activity']","[{'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0442035', 'cui_str': 'Peroneal'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0442035', 'cui_str': 'Peroneal'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015211', 'cui_str': 'Eversion'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}]",,0.029513,"However, after the intervention, healthy controls demonstrated significantly less ankle inversion between 0-9% ( p  = 0.009) and 82-87% ( p  = 0.011) of the stance phase.","[{'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Gottlieb', 'Affiliation': 'Neuromuscular and Human Performance Laboratory, Department of Physiotherapy, Faculty of Health Sciences, Ariel University, Ariel 40700, Israel.'}, {'ForeName': 'Jay R', 'Initials': 'JR', 'LastName': 'Hoffman', 'Affiliation': 'Neuromuscular and Human Performance Laboratory, Department of Physiotherapy, Faculty of Health Sciences, Ariel University, Ariel 40700, Israel.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Springer', 'Affiliation': 'Neuromuscular and Human Performance Laboratory, Department of Physiotherapy, Faculty of Health Sciences, Ariel University, Ariel 40700, Israel.'}]","Sensors (Basel, Switzerland)",['10.3390/s22041622']
2408,35214798,"Evaluation of the Safety, Tolerability and Immunogenicity of ShigETEC, an Oral Live Attenuated  Shigella -ETEC Vaccine in Placebo-Controlled Randomized Phase 1 Trial.","BACKGROUND


Shigella  spp. and enterotoxigenic  Escherichia coli  (ETEC) cause high morbidity and mortality worldwide, yet no licensed vaccines are available to prevent corresponding infections. A live attenuated non-invasive  Shigella  vaccine strain lacking LPS O-antigen and expressing the ETEC toxoids, named ShigETEC was characterized previously in non-clinical studies.
METHODS


ShigETEC was evaluated in a two-staged, randomized, double-blind and placebo-controlled Phase I clinical trial. A single dose of increasing amounts of the vaccine was given to determine the maximum tolerated dose and increasing number of immunizations were administered with an interval based on the duration of shedding observed.
RESULTS


Oral immunization with ShigETEC was well tolerated and safe up to 4-time dosing with 5 × 10 10  colony forming units. ShigETEC induced robust systemic immune responses against the  Shigella  vaccine strain, with IgA serum antibody dominance, as well as mucosal antibody responses evidenced by specific IgA in stool samples and in ALS (Antibodies in Lymphocyte Supernatant). Anti- ETEC toxin responses were detected primarily in the 4-times immunized cohort and for the heat-labile toxin correlated with neutralizing capacity.
CONCLUSION


ShigETEC is a promising vaccine candidate that is scheduled for further testing in controlled human challenge studies for efficacy as well as in children in endemic setting for safety and immunogenicity.",2022,"ShigETEC induced robust systemic immune responses against the  Shigella  vaccine strain, with IgA serum antibody dominance, as well as mucosal antibody responses evidenced by specific IgA in stool samples and in ALS",[],"['Placebo', 'ALS', 'placebo']","['tolerated and safe', 'Safety, Tolerability and Immunogenicity', 'Anti- ETEC toxin responses']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0580797', 'cui_str': 'Enterotoxigenic Escherichia coli'}, {'cui': 'C0040549', 'cui_str': 'Toxin'}]",,0.360815,"ShigETEC induced robust systemic immune responses against the  Shigella  vaccine strain, with IgA serum antibody dominance, as well as mucosal antibody responses evidenced by specific IgA in stool samples and in ALS","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Girardi', 'Affiliation': 'Eveliqure Biotechnologies GmbH, Karl-Farkas-Gasse 22, 1030 Vienna, Austria.'}, {'ForeName': 'Shushan', 'Initials': 'S', 'LastName': 'Harutyunyan', 'Affiliation': 'Eveliqure Biotechnologies GmbH, Karl-Farkas-Gasse 22, 1030 Vienna, Austria.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Neuhauser', 'Affiliation': 'Eveliqure Biotechnologies GmbH, Karl-Farkas-Gasse 22, 1030 Vienna, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Glaninger', 'Affiliation': 'Eveliqure Biotechnologies GmbH, Karl-Farkas-Gasse 22, 1030 Vienna, Austria.'}, {'ForeName': 'Orsolya', 'Initials': 'O', 'LastName': 'Korda', 'Affiliation': 'Eveliqure Biotechnologies GmbH, Karl-Farkas-Gasse 22, 1030 Vienna, Austria.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Nagy', 'Affiliation': 'Eveliqure Biotechnologies GmbH, Karl-Farkas-Gasse 22, 1030 Vienna, Austria.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Nagy', 'Affiliation': 'Eveliqure Biotechnologies GmbH, Karl-Farkas-Gasse 22, 1030 Vienna, Austria.'}, {'ForeName': 'Valéria', 'Initials': 'V', 'LastName': 'Szijártó', 'Affiliation': 'CEBINA GmbH, Karl-Farkas-Gasse 22, 1030 Vienna, Austria.'}, {'ForeName': 'Denes', 'Initials': 'D', 'LastName': 'Pall', 'Affiliation': 'Department of Medicine, Division of Clinical Pharmacology, University of Debrecen, Nagyerdei krt. 98, H-4032 Debrecen, Hungary.'}, {'ForeName': 'Krisztina', 'Initials': 'K', 'LastName': 'Szarka', 'Affiliation': 'Department of Medical Microbiology, Faculty of Medicine, University of Debrecen, Nagyerdei krt. 98, H-4032 Debrecen, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Kardos', 'Affiliation': 'Department of Medical Microbiology, Faculty of Medicine, University of Debrecen, Nagyerdei krt. 98, H-4032 Debrecen, Hungary.'}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Henics', 'Affiliation': 'Eveliqure Biotechnologies GmbH, Karl-Farkas-Gasse 22, 1030 Vienna, Austria.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Malinoski', 'Affiliation': 'Eveliqure Biotechnologies GmbH, Karl-Farkas-Gasse 22, 1030 Vienna, Austria.'}]",Vaccines,['10.3390/vaccines10020340']
2409,35215453,"The Effect of ß-Glucan Prebiotic on Kidney Function, Uremic Toxins and Gut Microbiome in Stage 3 to 5 Chronic Kidney Disease (CKD) Predialysis Participants: A Randomized Controlled Trial.","There is growing evidence that gut dysbiosis contributes to the progression of chronic kidney disease (CKD) owing to several mechanisms, including microbiota-derived uremic toxins, diet and immune-mediated factors. The aim of this study was to investigate the effect of a ß-glucan prebiotic on kidney function, uremic toxins and the gut microbiome in stage 3 to 5 CKD participants. Fifty-nine participants were randomized to either the ß-glucan prebiotic intervention group ( n =  30) or the control group ( n =  29). The primary outcomes were to assess kidney function (urea, creatinine and glomerular filtration rate), plasma levels of total and free levels of uremic toxins ( p -cresyl sulfate ( p CS), indoxyl-sulfate (IxS),  p -cresyl glucuronide ( p CG) and indoxyl 3-acetic acid (IAA) and gut microbiota using 16S rRNA sequencing at baseline, week 8 and week 14. The intervention group (age 40.6 ± 11.4 y) and the control group (age 41.3 ± 12.0 y) did not differ in age or any other socio-demographic variables at baseline. There were no significant changes in kidney function over 14 weeks. There was a significant reduction in uremic toxin levels at different time points, in free IxS at 8 weeks ( p  = 0.003) and 14 weeks ( p  < 0.001), free  p CS ( p  = 0.006) at 14 weeks and total and free  p CG ( p  < 0.001,  p  < 0.001, respectively) and at 14 weeks. There were no differences in relative abundances of genera between groups. Enterotyping revealed that the population consisted of only two of the four enterotypes:  Bacteroides  2 and  Prevotella . The redundancy analysis showed a few factors significantly affected the gut microbiome: these included triglyceride levels ( p  < 0.001), body mass index ( p  = 0.002), high- density lipoprotein ( p  < 0.001) and the prebiotic intervention ( p  = 0.002). The ß-glucan prebiotic significantly altered uremic toxin levels of intestinal origin and favorably affected the gut microbiome.",2022,"The redundancy analysis showed a few factors significantly affected the gut microbiome: these included triglyceride levels ( p  < 0.001), body mass index ( p  = 0.002), high- density lipoprotein ( p  < 0.001) and the prebiotic intervention ( p  = 0.002).","['stage 3 to 5 CKD participants', 'Fifty-nine participants', 'Stage 3 to 5 Chronic Kidney Disease (CKD) Predialysis Participants']","['ß-Glucan Prebiotic', 'ß-glucan prebiotic', 'ß-glucan prebiotic intervention']","['uremic toxin levels', 'kidney function, uremic toxins and the gut microbiome', 'Kidney Function, Uremic Toxins and Gut Microbiome', 'triglyceride levels', 'body mass index', 'kidney function (urea, creatinine and glomerular filtration rate), plasma levels of total and free levels of uremic toxins ( p -cresyl sulfate ( p CS), indoxyl-sulfate (IxS),  p -cresyl glucuronide ( p CG) and indoxyl 3-acetic acid (IAA) and gut microbiota using 16S rRNA sequencing', 'high- density lipoprotein', 'relative abundances of genera', 'kidney function']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C3830128', 'cui_str': '59'}]","[{'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040549', 'cui_str': 'Toxin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0021210', 'cui_str': 'Indican'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}, {'cui': 'C0063522', 'cui_str': 'indoxyl'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",59.0,0.0777195,"The redundancy analysis showed a few factors significantly affected the gut microbiome: these included triglyceride levels ( p  < 0.001), body mass index ( p  = 0.002), high- density lipoprotein ( p  < 0.001) and the prebiotic intervention ( p  = 0.002).","[{'ForeName': 'Zarina', 'Initials': 'Z', 'LastName': 'Ebrahim', 'Affiliation': 'Division of Human Nutrition, Department of Global Health, Stellenbosch University, Cape Town 8000, South Africa.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Proost', 'Affiliation': 'Laboratory of Molecular Bacteriology, Department of Microbiology and Immunology, Rega Institute, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Raul Yhossef', 'Initials': 'RY', 'LastName': 'Tito', 'Affiliation': 'Laboratory of Molecular Bacteriology, Department of Microbiology and Immunology, Rega Institute, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Raes', 'Affiliation': 'Laboratory of Molecular Bacteriology, Department of Microbiology and Immunology, Rega Institute, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Griet', 'Initials': 'G', 'LastName': 'Glorieux', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Nephrology Section, Ghent University Hospital, 9000 Ghent, Belgium.'}, {'ForeName': 'Mohammed Rafique', 'Initials': 'MR', 'LastName': 'Moosa', 'Affiliation': 'Department of Medicine, Stellenbosch University, Cape Town 8000, South Africa.'}, {'ForeName': 'Renée', 'Initials': 'R', 'LastName': 'Blaauw', 'Affiliation': 'Division of Human Nutrition, Department of Global Health, Stellenbosch University, Cape Town 8000, South Africa.'}]",Nutrients,['10.3390/nu14040805']
2410,35215431,Effect of Different Functional Food Supplements on the Gut Microbiota of Prediabetic Indonesian Individuals during Weight Loss.,"The gut microbiota has been shown in recent years to be involved in the development and severity of type 2 diabetes (T2D). The aim of the present study was to test the effect of a 2-week functional food intervention on the gut microbiota composition in prediabetic individuals. A randomized double-blind, cross-over trial was conducted on prediabetic subjects. Fifteen volunteers were provided products made of: (i) 50% taro flour + 50% wheat flour; (ii) these products and the probiotic  L. plantarum  IS-10506; or (iii) these products with beetroot adsorbed for a period of 2 weeks with 2 weeks wash-out in between. Stool and blood samples were taken at each baseline and after each of the interventions. The gut microbiota composition was evaluated by sequencing the V3-V4 region of the 16S rRNA gene and anthropometric measures were recorded. The total weight loss over the entire period ranged from 0.5 to 11 kg. The next-generation sequencing showed a highly personalized microbiota composition. In the principal coordinate analyses, the samples of each individual clustered closer together than the samples of each treatment. For six individuals, the samples clustered closely together, indicating a stable microbiota. For nine individuals, the microbiota was less resilient and, depending on the intervention, the beta-diversity transiently differed greatly only to return to the composition close to the baseline during the wash-out. The statistical analyses showed that 202 of the total 304 taxa were significantly different between the participants. Only  Butyricimonas  could be correlated with taro ingestion. The results of the study show that the highly variable interindividual variation observed in the gut microbiota of the participants clouded any gut microbiota modulation that might be present due to the functional food interventions.",2022,"For nine individuals, the microbiota was less resilient and, depending on the intervention, the beta-diversity transiently differed greatly only to return to the composition close to the baseline during the wash-out.","['prediabetic individuals', 'prediabetic subjects', 'Prediabetic Indonesian Individuals during Weight Loss', 'Fifteen volunteers were provided products made of: (i) 50']","['Functional Food Supplements', 'functional food intervention', 'taro flour + 50% wheat flour; (ii) these products and the probiotic  L. plantarum  IS-10506']","['gut microbiota composition', 'Stool and blood samples', 'total weight loss']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C2717755', 'cui_str': 'Functional Food'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453146', 'cui_str': 'Taro'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0458980', 'cui_str': 'Wheat flour'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C1231534', 'cui_str': 'Curtobacterium plantarum'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",304.0,0.092303,"For nine individuals, the microbiota was less resilient and, depending on the intervention, the beta-diversity transiently differed greatly only to return to the composition close to the baseline during the wash-out.","[{'ForeName': 'Ingrid S', 'Initials': 'IS', 'LastName': 'Surono', 'Affiliation': 'Food Technology Department, Faculty of Engineering, Bina Nusantara University, Jakarta 11480, Indonesia.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Simatupang', 'Affiliation': 'Faculty of Medicine, Universitas Kristen Indonesia, Jakarta 13630, Indonesia.'}, {'ForeName': 'Pratiwi D', 'Initials': 'PD', 'LastName': 'Kusumo', 'Affiliation': 'Faculty of Medicine, Universitas Kristen Indonesia, Jakarta 13630, Indonesia.'}, {'ForeName': 'Priyo', 'Initials': 'P', 'LastName': 'Waspodo', 'Affiliation': 'Food Technology Department, Faculty of Engineering, Bina Nusantara University, Jakarta 11480, Indonesia.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Verbruggen', 'Affiliation': 'Centre for Healthy Eating & Food Innovation, Maastricht University-Campus Venlo, 5928 SZ Venlo, The Netherlands.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Verhoeven', 'Affiliation': 'Centre for Healthy Eating & Food Innovation, Maastricht University-Campus Venlo, 5928 SZ Venlo, The Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Venema', 'Affiliation': 'Centre for Healthy Eating & Food Innovation, Maastricht University-Campus Venlo, 5928 SZ Venlo, The Netherlands.'}]",Nutrients,['10.3390/nu14040781']
2411,35215430,Improved Endurance Running Performance Following Haskap Berry ( Lonicera caerulea  L.) Ingestion.,"BACKGROUND


Food high in (poly)phenolic compounds, such as anthocyanins, have the potential to improve exercise recovery and exercise performance. Haskap berries are rich in anthocyanins, but no research has examined the potential to improve human performance. The aim of this study was to determine the influence of Haskap berry on parameters of endurance running performance.
METHODS


Using a double-blind, placebo controlled, independent groups design, 30 male recreational runners (mean ± SD age, 33 ± 7 years; stature, 178.2 ± 7.2 cm; mass, 77.7 ± 10.6 kg; V˙O 2peak , 52.2 ± 6.6 mL/kg/min) volunteered to participate. Following familiarisation, volunteers visited the laboratory twice (separated by seven days) to assess submaximal, maximal and 5 km time trial running performance. After the first visit, volunteers were randomly assigned to consume either the Haskap berry intervention or an isocaloric placebo control.
RESULTS


There were modest changes in heart rate and V˙O 2  at submaximal intensities ( p  < 0.05). Time to exhaustion during the V˙O 2peak  test was longer in the Haskap group by 20 s ( p  = 0.031). Additionally, 5 km time trial performance was improved in the Haskap group by ~21 s ( p  = 0.016), which equated to a 0.25 km/h increase in mean running speed compared to the placebo control; this represented a >2% improvement in running performance.
CONCLUSIONS


The application of this newly identified functional food to athletes has the capacity to improve endurance running performance.",2022,There were modest changes in heart rate and V˙O 2  at submaximal intensities ( p  < 0.05).,"['30 male recreational runners (mean ± SD age, 33 ± 7 years; stature, 178.2 ± 7.2 cm; mass, 77.7 ± 10.6 kg; V˙O 2peak , 52.2 ± 6.6 mL/kg/min) volunteered to participate']","['Haskap Berry ( Lonicera caerulea  L', 'Haskap berry intervention or an isocaloric placebo control', 'placebo']","['heart rate and V˙O 2  at submaximal intensities', 'Improved Endurance Running Performance', 'Time to exhaustion during the V˙O 2peak  test', 'mean running speed']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517801', 'cui_str': '52.2'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0005135', 'cui_str': 'Berry'}, {'cui': 'C0331065', 'cui_str': 'Lonicera'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",30.0,0.28291,There were modest changes in heart rate and V˙O 2  at submaximal intensities ( p  < 0.05).,"[{'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Howatson', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne NE1 8ST, UK.'}, {'ForeName': 'Gemma C', 'Initials': 'GC', 'LastName': 'Snaith', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne NE1 8ST, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kimble', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne NE2 4HH, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Cowper', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne NE1 8ST, UK.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Keane', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne NE1 8ST, UK.'}]",Nutrients,['10.3390/nu14040780']
2412,35215405,"Effect of 12-Week Intake of Nicotinamide Mononucleotide on Sleep Quality, Fatigue, and Physical Performance in Older Japanese Adults: A Randomized, Double-Blind Placebo-Controlled Study.","Deteriorating sleep quality and physical or mental fatigue in older adults leads to decreased quality of life and increased mortality rates. This study investigated the effects of the time-dependent intake of nicotinamide mononucleotide (NMN) on sleep quality, fatigue, and physical performance in older adults. This randomized, double-blind placebo-controlled study evaluated 108 participants divided into four groups (NMN_AM; antemeridian, NMN_PM; post meridian, Placebo_AM, Placebo_PM). NMN (250 mg) or placebo was administered once a day for 12 weeks. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index. Fatigue was evaluated using the ""Jikaku-sho shirabe"" questionnaire. Grip strength, 5-times sit-to-stand (5-STS), timed up and go, and 5-m habitual walk were evaluated to assess the physical performance. Significant interactions were observed between 5-STS and drowsiness. 5-STS of all groups on post-intervention and drowsiness of the NMN_PM and Placebo_PM groups on mid- and post-intervention showed significant improvement compared with those in pre-intervention. The NMN_PM group demonstrated the largest effect size for 5-STS (d = 0.72) and drowsiness (d = 0.64). Overall, NMN intake in the afternoon effectively improved lower limb function and reduced drowsiness in older adults. These findings suggest the potential of NMN in preventing loss of physical performance and improving fatigue in older adults.",2022,The NMN_PM group demonstrated the largest effect size for 5-STS (d = 0.72) and drowsiness (d = 0.64).,"['Older Japanese Adults', 'older adults', '108 participants divided into four groups (NMN_AM; antemeridian']","['nicotinamide mononucleotide (NMN', 'placebo', 'Nicotinamide Mononucleotide', 'Placebo', 'NMN', 'NMN_PM', 'NMN_PM; post meridian, Placebo_AM, Placebo_PM']","['Grip strength, 5-times sit-to-stand (5-STS), timed up and go, and 5-m habitual walk', 'largest effect size for 5-STS', 'Fatigue', 'lower limb function and reduced drowsiness', 'Pittsburgh Sleep Quality Index', 'Deteriorating sleep quality and physical or mental fatigue', 'sleep quality, fatigue, and physical performance', 'physical performance and improving fatigue', '5-STS and drowsiness', 'drowsiness', 'quality of life and increased mortality rates', 'Sleep Quality, Fatigue, and Physical Performance', 'Sleep quality']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0028032', 'cui_str': 'Nicotinamide mononucleotide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",108.0,0.0681573,The NMN_PM group demonstrated the largest effect size for 5-STS (d = 0.72) and drowsiness (d = 0.64).,"[{'ForeName': 'Mijin', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'R&D Center for Tailor-Made QOL, University of Tsukuba, Tsukuba 305-8550, Japan.'}, {'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Seol', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba 305-8572, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Research and Development Division, Mitsubishi Corporation Life Sciences Limited, Tokyo 100-0006, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Fukamizu', 'Affiliation': 'Research and Development Division, Mitsubishi Corporation Life Sciences Limited, Tokyo 100-0006, Japan.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Sakurai', 'Affiliation': 'Research and Development Division, Mitsubishi Corporation Life Sciences Limited, Tokyo 100-0006, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Okura', 'Affiliation': 'R&D Center for Tailor-Made QOL, University of Tsukuba, Tsukuba 305-8550, Japan.'}]",Nutrients,['10.3390/nu14040755']
2413,35215312,Mineralocorticoid Receptor Antagonist (Potassium Canrenoate) Does Not Influence Outcome in the Treatment of COVID-19-Associated Pneumonia and Fibrosis-A Randomized Placebo Controlled Clinical Trial.,"In December 2019 the SARS-CoV-2 virus appeared in the world, mainly presenting as an acute infection of the lower respiratory tract, namely pneumonia. Nearly 10% of all patients show significant pulmonary fibrotic changes after the infection. The aim of this study was to evaluate the effectiveness and safety of potassium canrenoate in the treatment of COVID-19-associated pneumonia and pulmonary fibrosis. We performed a randomized clinical trial (RCT) of potassium canrenoate vs placebo. A total of 55 patients were randomized and 49 were included in the final analysis (24 allocated to the intervention group and 25 allocated to the control group). Patients were assessed by physical examination, lung ultrasound, CT imaging and blood samples that underwent biochemical analysis. This RCT has shown that the administration of potassium canrenoate to patients with COVID-19 induced pneumonia was not associated with shorter mechanical ventilation time, shorter passive oxygenation, shorter length of hospitalization or less fibrotic changes on CT imaging. The overall mortality rate was not significantly different between the two groups. Adverse events recorded in this study were not significantly increased by the administration of potassium canrenoate. The negative outcome of the study may be associated with the relatively small number of patients included. Any possible benefits from the use of potassium canrenoate as an antifibrotic drug in COVID-19 patients require further investigation.",2022,The overall mortality rate was not significantly different between the two groups.,"['A total of 55 patients were randomized and 49 were included in the final analysis', 'COVID-19-associated pneumonia and pulmonary fibrosis']","['potassium canrenoate vs placebo', 'Mineralocorticoid Receptor Antagonist (Potassium Canrenoate', 'Placebo', 'potassium canrenoate']","['pulmonary fibrotic changes', 'effectiveness and safety', 'mechanical ventilation time, shorter passive oxygenation, shorter length of hospitalization', 'physical examination, lung ultrasound, CT imaging and blood samples', 'overall mortality rate', 'Adverse events']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}]","[{'cui': 'C0006881', 'cui_str': 'potassium canrenoate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",55.0,0.0994347,The overall mortality rate was not significantly different between the two groups.,"[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Kotfis', 'Affiliation': 'Department of Anesthesiology, Intensive Therapy and Acute Intoxications, Pomeranian Medical University, 70-111 Szczecin, Poland.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Karolak', 'Affiliation': 'Department of Anesthesiology, Intensive Therapy and Acute Intoxications, Pomeranian Medical University, 70-111 Szczecin, Poland.'}, {'ForeName': 'Kacper', 'Initials': 'K', 'LastName': 'Lechowicz', 'Affiliation': 'Department of Anesthesiology, Intensive Therapy and Acute Intoxications, Pomeranian Medical University, 70-111 Szczecin, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Zegan-Barańska', 'Affiliation': 'Department of Anesthesiology, Intensive Therapy and Acute Intoxications, Pomeranian Medical University, 70-111 Szczecin, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Pikulska', 'Affiliation': 'Department of Anesthesiology, Intensive Therapy and Acute Intoxications, Pomeranian Medical University, 70-111 Szczecin, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Niedźwiedzka-Rystwej', 'Affiliation': 'Institute of Biology, University of Szczecin, 71-412 Szczecin, Poland.'}, {'ForeName': 'Miłosz', 'Initials': 'M', 'LastName': 'Kawa', 'Affiliation': 'Department of Radiology, Pomeranian Medical University, 70-111 Szczecin, Poland.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Sieńko', 'Affiliation': 'Department of General and Transplantation Surgery, Pomeranian Medical University, 70-111 Szczecin, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Szylińska', 'Affiliation': 'Department of Medical Rehabilitation and Clinical Physiotherapy, Pomeranian Medical University, 71-111 Szczecin, Poland.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Wiśniewska', 'Affiliation': 'Clinical Department of Nephrology, Transplantology and Internal Medicine, Pomeranian Medical University, 70-111 Szczecin, Poland.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph15020200']
2414,35215305,"Pharmacokinetics and Bioequivalence of Two Empagliflozin, with Evaluation in Healthy Jordanian Subjects under Fasting and Fed Conditions.","The current study is a randomized, open-label, two-period, two-sequence, two-way crossover pharmacokinetic study in healthy Jordanian subjects to evaluate the pharmacokinetics and bioequivalence profile of two cases of empagliflozin 10 mg under fasting and fed conditions. The plasma concentrations of empagliflozin were determined using an HPLC-MS/MS method. Tolerability and safety were assessed throughout the study. This study included 26 subjects, 26 in both fasting and fed groups.The pharmacokinetic parameters, which included the area under the concentration-time curve from time zero to infinity (AUC 0-inf ) and the final quantifiable concentration (AUC 0-last ), maximum serum concentration (C max ), and time to reach the maximum drug concentration (T max ) were found to be within an equivalence margin of 80.00-125.00%. The pharmacokinetic profiles show that the empagliflozin test and parent reference cases were bioequivalent in healthy subjects. The two treatments' safety evaluations were also comparable.",2022,The two treatments' safety evaluations were also comparable.,"['10 mg under fasting and fed conditions', 'healthy subjects', 'healthy Jordanian subjects', 'Healthy Jordanian Subjects under Fasting and Fed Conditions', '26 subjects, 26 in both fasting and fed groups']","['Two Empagliflozin', 'empagliflozin']","['plasma concentrations of empagliflozin', 'concentration-time curve from time zero to infinity (AUC 0-inf ) and the final quantifiable concentration (AUC 0-last ), maximum serum concentration (C max ), and time to reach the maximum drug concentration (T max ', 'Tolerability and safety']","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",26.0,0.0119971,The two treatments' safety evaluations were also comparable.,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hailat', 'Affiliation': 'Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman 11733, Jordan.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Zakaraya', 'Affiliation': 'Faculty of Pharmacy, Al-Ahliyya Amman University, Amman 19328, Jordan.'}, {'ForeName': 'Israa', 'Initials': 'I', 'LastName': 'Al-Ani', 'Affiliation': 'Faculty of Pharmacy, Al-Ahliyya Amman University, Amman 19328, Jordan.'}, {'ForeName': 'Osaid Al', 'Initials': 'OA', 'LastName': 'Meanazel', 'Affiliation': 'Michael Sayegh Faculty of Pharmacy, Aqaba University of Technology, Aqaba 77110, Jordan.'}, {'ForeName': 'Ramadan', 'Initials': 'R', 'LastName': 'Al-Shdefat', 'Affiliation': 'Faculty of Pharmacy, Jadara University, Irbid 21110, Jordan.'}, {'ForeName': 'Md Khalid', 'Initials': 'MK', 'LastName': 'Anwer', 'Affiliation': 'Department of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.'}, {'ForeName': 'Mohamed J', 'Initials': 'MJ', 'LastName': 'Saadh', 'Affiliation': 'Faculty of Pharmacy, Middle East University, Amman 11831, Jordan.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Abu Dayyih', 'Affiliation': 'Faculty of Pharmacy, Mutah University, Al-Karak 61710, Jordan.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph15020193']
2415,35196426,Treating Rhythmic and Periodic EEG Patterns in Comatose Survivors of Cardiac Arrest.,"BACKGROUND


Whether the treatment of rhythmic and periodic electroencephalographic (EEG) patterns in comatose survivors of cardiac arrest improves outcomes is uncertain.
METHODS


We conducted an open-label trial of suppressing rhythmic and periodic EEG patterns detected on continuous EEG monitoring in comatose survivors of cardiac arrest. Patients were randomly assigned in a 1:1 ratio to a stepwise strategy of antiseizure medications to suppress this activity for at least 48 consecutive hours plus standard care (antiseizure-treatment group) or to standard care alone (control group); standard care included targeted temperature management in both groups. The primary outcome was neurologic outcome according to the score on the Cerebral Performance Category (CPC) scale at 3 months, dichotomized as a good outcome (CPC score indicating no, mild, or moderate disability) or a poor outcome (CPC score indicating severe disability, coma, or death). Secondary outcomes were mortality, length of stay in the intensive care unit (ICU), and duration of mechanical ventilation.
RESULTS


We enrolled 172 patients, with 88 assigned to the antiseizure-treatment group and 84 to the control group. Rhythmic or periodic EEG activity was detected a median of 35 hours after cardiac arrest; 98 of 157 patients (62%) with available data had myoclonus. Complete suppression of rhythmic and periodic EEG activity for 48 consecutive hours occurred in 49 of 88 patients (56%) in the antiseizure-treatment group and in 2 of 83 patients (2%) in the control group. At 3 months, 79 of 88 patients (90%) in the antiseizure-treatment group and 77 of 84 patients (92%) in the control group had a poor outcome (difference, 2 percentage points; 95% confidence interval, -7 to 11; P = 0.68). Mortality at 3 months was 80% in the antiseizure-treatment group and 82% in the control group. The mean length of stay in the ICU and mean duration of mechanical ventilation were slightly longer in the antiseizure-treatment group than in the control group.
CONCLUSIONS


In comatose survivors of cardiac arrest, the incidence of a poor neurologic outcome at 3 months did not differ significantly between a strategy of suppressing rhythmic and periodic EEG activity with the use of antiseizure medication for at least 48 hours plus standard care and standard care alone. (Funded by the Dutch Epilepsy Foundation; TELSTAR ClinicalTrials.gov number, NCT02056236.).",2022,Mortality at 3 months was 80% in the antiseizure-treatment group and 82% in the control group.,"['Comatose Survivors of Cardiac Arrest', 'comatose survivors of cardiac arrest', 'comatose survivors', 'We enrolled 172 patients, with 88 assigned to the antiseizure-treatment group and 84 to the control group']",['antiseizure medications to suppress this activity for at least 48 consecutive hours plus standard care (antiseizure-treatment group) or to standard care alone (control group); standard care included targeted temperature management'],"['neurologic outcome according to the score on the Cerebral Performance Category', 'good outcome (CPC score indicating no, mild, or moderate disability) or a poor outcome (CPC score indicating severe disability, coma, or death', 'Mortality', 'Complete suppression of rhythmic and periodic EEG activity', 'CPC) scale', 'mortality, length of stay in the intensive care unit (ICU), and duration of mechanical ventilation', 'Rhythmic or periodic EEG activity', 'mean length of stay in the ICU and mean duration of mechanical ventilation']","[{'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",172.0,0.129417,Mortality at 3 months was 80% in the antiseizure-treatment group and 82% in the control group.,"[{'ForeName': 'Barry J', 'Initials': 'BJ', 'LastName': 'Ruijter', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Hanneke M', 'Initials': 'HM', 'LastName': 'Keijzer', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Marleen C', 'Initials': 'MC', 'LastName': 'Tjepkema-Cloostermans', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Michiel J', 'Initials': 'MJ', 'LastName': 'Blans', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Albertus', 'Initials': 'A', 'LastName': 'Beishuizen', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Selma C', 'Initials': 'SC', 'LastName': 'Tromp', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Scholten', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Horn', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Anne-Fleur', 'Initials': 'AF', 'LastName': 'van Rootselaar', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Marjolein M', 'Initials': 'MM', 'LastName': 'Admiraal', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'van den Bergh', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Jan-Willem J', 'Initials': 'JJ', 'LastName': 'Elting', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Norbert A', 'Initials': 'NA', 'LastName': 'Foudraine', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Francois H M', 'Initials': 'FHM', 'LastName': 'Kornips', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Vivianne H J M', 'Initials': 'VHJM', 'LastName': 'van Kranen-Mastenbroek', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Rob P W', 'Initials': 'RPW', 'LastName': 'Rouhl', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Elsbeth C', 'Initials': 'EC', 'LastName': 'Thomeer', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Moudrous', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Frouke A P', 'Initials': 'FAP', 'LastName': 'Nijhuis', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Suzanne J', 'Initials': 'SJ', 'LastName': 'Booij', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Cornelia W E', 'Initials': 'CWE', 'LastName': 'Hoedemaekers', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Jonne', 'Initials': 'J', 'LastName': 'Doorduin', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Fabio S', 'Initials': 'FS', 'LastName': 'Taccone', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Michel J A M', 'Initials': 'MJAM', 'LastName': 'van Putten', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Hofmeijer', 'Affiliation': 'From the Department of Clinical Neurophysiology, Technical Medical Center (B.J.R., M.C.T.-C., M.J.A.M.P., J. Hofmeijer), and the Section of Cognition, Data, and Education (J.P.), University of Twente, and the Departments of Neurology and Clinical Neurophysiology (M.C.T.-C., M.J.A.M.P.), the Intensive Care Center (A.B.), and the Department of Epidemiology (J.P.), Medisch Spectrum Twente, Enschede, the Departments of Neurology (H.M.K., J. Hofmeijer) and Intensive Care (M.J.B.), Rijnstate Hospital, Arnhem, the Departments of Intensive Care Medicine (H.M.K., C.W.E.H.) and Neurology (H.M.K., J.D.) and the Donders Institute for Brain, Cognition, and Behavior (H.M.K.), Radboud University Medical Center, and the Department of Neurology, Canisius Wilhelmina Hospital (F.A.P.N., S.J.B.), Nijmegen, the Departments of Neurology and Clinical Neurophysiology (S.C.T.) and Intensive Care (E.S.), St. Antonius Hospital, Nieuwegein, the Department of Neurology, Leiden University Medical Center, Leiden (S.C.T.), the Amsterdam Coma Group (J. Horn, A.-F.R., M.M.A.), the Department of Intensive Care (J. Horn), and the Department of Neurology and Clinical Neurophysiology (A.-F.R., M.M.A.), Amsterdam University Medical Center, Amsterdam, the Departments of Critical Care (W.M.B.) and Neurology and Clinical Neurophysiology (J.W.J.E.), University Medical Center Groningen, University of Groningen, Groningen, the Departments of Intensive Care (N.A.F.) and Neurology (F.H.M.K.), VieCuri Medical Center, Venlo, the Departments of Clinical Neurophysiology (V.H.J.M.K.-M.) and Neurology (R.P.W.R.), Maastricht University Medical Center, and the Academic Center for Epileptology Kempenhaeghe and Maastricht UMC+ (V.H.J.M.K.-M., R.P.W.R.), Maastricht, and the Department of Neurology, Maasstad Hospital, Rotterdam (E.C.T., W.M.) - all in the Netherlands; and the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2115998']
2416,35206793,Educational Videos as an Adjunct Learning Tool in Pre-Clinical Operative Dentistry-A Randomized Control Trial.,"BACKGROUND


E-learning is an important adjunct used for teaching clinical skills in medicine dentistry. This study evaluated and compared the effectiveness of e-learning resources as an additional teaching aid to traditional teaching methods in male and female students and based on CGPA scores in a pre-clinical operative skill course.
METHODS


A randomized control trial was conducted in the College of Dentistry, Jouf University, to assess the impact of e-learning resources in learning clinical skills in a pre-clinical operative dentistry course. Fifty second-year dental students were randomly divided into two groups, with 25 students each. Group A (control group) was taught using traditional teaching methods, and Group B (intervention group) used e-learning resources along with traditional methods. Both groups were assessed using objective structured clinical examinations (OSCEs). Standardized forms prepared by faculty members were used to assess the students. The students also filled in a questionnaire afterwards to provide feedback regarding the e-learning resources.
RESULTS


The difference between both groups was statistically significant ( p  < 0.05). Female students performed better in three OSCE stations out of six. Furthermore, the students positively responded to the use of additional resources.
CONCLUSION


The use of e-learning resources in pre-clinical operative dentistry courses can be a useful adjunct to traditional teaching methods and can result in better learning of dental pre-clinical operative skills.",2022,The use of e-learning resources in pre-clinical operative dentistry courses can be a useful adjunct to traditional teaching methods and can result in better learning of dental pre-clinical operative skills.,"['Female students', 'male and female students and based on CGPA scores in a pre-clinical operative skill course', 'Fifty second-year dental students', 'College of Dentistry, Jouf University']","['traditional teaching methods, and Group B (intervention group) used e-learning resources along with traditional methods']",['objective structured clinical examinations (OSCEs'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0560828,The use of e-learning resources in pre-clinical operative dentistry courses can be a useful adjunct to traditional teaching methods and can result in better learning of dental pre-clinical operative skills.,"[{'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Khattak', 'Affiliation': 'Department of Operative Dentistry & Endodontics, Jouf University, Sakaka 72345, Saudi Arabia.'}, {'ForeName': 'Kiran Kumar', 'Initials': 'KK', 'LastName': 'Ganji', 'Affiliation': 'Department of Preventive Dentistry, Jouf University, Sakaka 72345, Saudi Arabia.'}, {'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Iqbal', 'Affiliation': 'Department of Operative Dentistry & Endodontics, Jouf University, Sakaka 72345, Saudi Arabia.'}, {'ForeName': 'Meshal', 'Initials': 'M', 'LastName': 'Alonazi', 'Affiliation': 'Department of Operative Dentistry & Endodontics, Jouf University, Sakaka 72345, Saudi Arabia.'}, {'ForeName': 'Hmoud', 'Initials': 'H', 'LastName': 'Algarni', 'Affiliation': 'Department of Operative Dentistry & Endodontics, Jouf University, Sakaka 72345, Saudi Arabia.'}, {'ForeName': 'Thani', 'Initials': 'T', 'LastName': 'Alsharari', 'Affiliation': 'Restorative and Dental Materials Department, Faculty of Dentistry, Taif University, Taif 26571, Saudi Arabia.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare10020178']
2417,35206703,Cricket Meal ( Gryllus bimaculatus ) as a Protein Supplement on In Vitro Fermentation Characteristics and Methane Mitigation.,"The aim of this work was to conduct the effects of cricket ( Gryllus bimaculatus ) meal (CM) as a protein supplement on in vitro gas production, rumen fermentation, and methane (CH 4 ) mitigation. Dietary treatments were randomly assigned using a completely randomized design (CRD) with a 2 × 5 factorial arrangement. The first factor was two ratios of roughage to concentrate (R:C at 60:40 and 40:60), and the second factor was the level of CM to replace soybean meal (SBM) in a concentrate ratio at 100:0, 75:25, 50:50, 25:75, and 0:100, respectively. It was found that in vitro DM degradability and the concentration of propionic (C 3 ) were significantly increased ( p  < 0.05), while the potential extent of gas production (a + b), acetate (C 2 ), acetate and propionate (C 2 :C 3 ) ratio, and protozoal population were reduced ( p  < 0.05) by lowering the R:C ratio and the replacement of SBM by CM. In addition, rumen CH 4  production was mitigated ( p  < 0.05) with increasing levels of CM for SBM. In this study, CM has the potential to improve rumen fermentation by enhancing C 3  concentration and DM degradability, reduced methane production, and C 2 :C 3  ratio. The effects were more pronounced ( p  < 0.05) at low levels of roughage.",2022,"In addition, rumen CH 4  production was mitigated ( p  < 0.05) with increasing levels of CM for SBM.",[],"['Cricket Meal ( Gryllus bimaculatus ', 'cricket ( Gryllus bimaculatus ) meal (CM']","['vitro gas production, rumen fermentation, and methane (CH 4 ) mitigation', 'vitro DM degradability and the concentration of propionic (C 3 ']",[],"[{'cui': 'C0018288', 'cui_str': 'Cricket'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0015852', 'cui_str': 'Fermentation'}, {'cui': 'C0025617', 'cui_str': 'Methane'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0590271,"In addition, rumen CH 4  production was mitigated ( p  < 0.05) with increasing levels of CM for SBM.","[{'ForeName': 'Burarat', 'Initials': 'B', 'LastName': 'Phesatcha', 'Affiliation': 'Department of Agricultural Technology and Environment, Faculty of Sciences and Liberal Arts, Rajamangala University of Technology Isan, Nakhon Ratchasima 30000, Thailand.'}, {'ForeName': 'Kampanat', 'Initials': 'K', 'LastName': 'Phesatcha', 'Affiliation': 'Department of Animal Science, Faculty of Agriculture and Technology, Nakhon Phanom University, Nakhon Phanom 48000, Thailand.'}, {'ForeName': 'Bounnaxay', 'Initials': 'B', 'LastName': 'Viennaxay', 'Affiliation': 'Tropical Feed Resources Research and Development Center (TROFREC), Department of Animal Science, Faculty of Agriculture, Khon Kaen University, Khon Kaen 40002, Thailand.'}, {'ForeName': 'Maharach', 'Initials': 'M', 'LastName': 'Matra', 'Affiliation': 'Tropical Feed Resources Research and Development Center (TROFREC), Department of Animal Science, Faculty of Agriculture, Khon Kaen University, Khon Kaen 40002, Thailand.'}, {'ForeName': 'Pajaree', 'Initials': 'P', 'LastName': 'Totakul', 'Affiliation': 'Tropical Feed Resources Research and Development Center (TROFREC), Department of Animal Science, Faculty of Agriculture, Khon Kaen University, Khon Kaen 40002, Thailand.'}, {'ForeName': 'Metha', 'Initials': 'M', 'LastName': 'Wanapat', 'Affiliation': 'Tropical Feed Resources Research and Development Center (TROFREC), Department of Animal Science, Faculty of Agriculture, Khon Kaen University, Khon Kaen 40002, Thailand.'}]",Insects,['10.3390/insects13020129']
2418,35206569,Differential Metabolites and Metabolic Pathways Involved in Aerobic Exercise Improvement of Chronic Fatigue Symptoms in Adolescents Based on Gas Chromatography-Mass Spectrometry.,"Studies have found that the prevalence of chronic fatigue syndrome (CFS) in adolescents has continued to increase over the years, affecting learning and physical health. High school is a critical stage for adolescents to grow and mature. There are inadequate detection and rehabilitation methods for CFS due to an insufficient understanding of the physiological mechanisms of CFS. The purpose of this study was to evaluate the effect and metabolic mechanisms of an aerobic running intervention program for high school students with CFS. Forty-six male high school students with CFS were randomly assigned to the exercise intervention group (EI) and control group (CFS). Twenty-four age- and sex-matched healthy male students were recruited as healthy controls (HCs). The EI group received the aerobic intervention for 12 weeks, three times a week, in 45-min sessions; the CFS group maintained their daily routines as normal. The outcome measures included fatigue symptoms and oxidation levels. Keratin was extracted from the nails of all participants, and the oxidation level was assessed by measuring the content of 3-Nitrotyrosine (3-NT) in the keratin by ultraviolet spectrophotometry. All participants' morning urine was collected to analyze urinary differential metabolites by the GC-MS technique before and after the intervention, and MetaboAnalyst 5.0 was used for pathway analysis. Compared with before the intervention, the fatigue score and 3-NT level in the EI group were significantly decreased after the intervention. The CFS group was screened for 20 differential metabolites involving the disruption of six metabolic pathways, including arginine biosynthesis, glycerolipid metabolism, pentose phosphate pathway, purine metabolism, β-alanine metabolism, and arginine and proline metabolism. After the intervention, 21 differential metabolites were screened, involved in alterations in three metabolic pathways: beta-alanine metabolism, pentose phosphate metabolism, and arginine and proline metabolism. Aerobic exercise was found to lessen fatigue symptoms and oxidative levels in students with CFS, which may be related to the regulation of putrescine (arginine and proline metabolism), 6-Phospho-D-Gluconate (starch and sucrose metabolism pathway), and Pentose (phosphate metabolism pathway).",2022,"Compared with before the intervention, the fatigue score and 3-NT level in the EI group were significantly decreased after the intervention.","['Forty-six male high school students with CFS', 'Twenty-four age- and sex-matched healthy male students were recruited as healthy controls (HCs', 'high school students with CFS', 'students with CFS']","['CFS', 'aerobic intervention', 'Aerobic exercise', 'exercise intervention group (EI) and control group (CFS', 'aerobic running intervention program']","['fatigue symptoms and oxidative levels', 'oxidation level', 'fatigue symptoms and oxidation levels', 'fatigue score and 3-NT level']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032052', 'cui_str': 'Human placental lactogen'}]","[{'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0047645', 'cui_str': '3-nitrotyrosine'}]",46.0,0.025827,"Compared with before the intervention, the fatigue score and 3-NT level in the EI group were significantly decreased after the intervention.","[{'ForeName': 'Shanguang', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Institute of Physical Education, Shaanxi Normal University, Xi'an 710119, China.""}, {'ForeName': 'Aiping', 'Initials': 'A', 'LastName': 'Chi', 'Affiliation': ""Institute of Physical Education, Shaanxi Normal University, Xi'an 710119, China.""}, {'ForeName': 'Bingjun', 'Initials': 'B', 'LastName': 'Wan', 'Affiliation': ""Institute of Physical Education, Shaanxi Normal University, Xi'an 710119, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'First Middle School of Shenmu City, Shenmu 719300, China.'}]",International journal of environmental research and public health,['10.3390/ijerph19042377']
2419,35207011,The Effect of the Schroth Rehabilitation Exercise Program on Spinal and Feet Alignment in Adolescent Patients with Idiopathic Scoliosis: A Pilot Study.,"BACKGROUND


This study investigated the therapeutic effects of 12-week Schroth rehabilitation exercises (SRE) in improving Cobb's angle, scoliometer readings, lumbar lordosis, and the calcaneal valgus angle of patients with idiopathic scoliosis.
METHODS


This pilot study included 60 adolescent patients diagnosed with idiopathic scoliosis by a rehabilitation physician based on a Cobb's angle of ≥10° using total anteroposterior plain radiography. Patients were classified into groups with a Cobb's angle of 10-19° (G1), 20-29° (G2), and ≥30° (G3). Cobb's angle, scoliometer readings, lumbar lordosis, and calcaneal valgus angles were analyzed before and after the 12-week SRE.
RESULTS


SRE improved Cobb's angle (-6.85), scoliometer readings (-2.80), lumbar lordosis (4.23), and calcaneal valgus angles (left, -3.76; right, -2.83) regardless of the initial scoliosis angle, and within-group changes were significant ( p  < 0.001). In this study, participants in all three groups had undergone SRE, regardless of initial scoliosis severity, and the findings were significant.
CONCLUSION


SRE can be used for patients with idiopathic scoliosis to improve asymmetric musculoskeletal morphology and the patient's quality of life.",2022,"RESULTS


SRE improved Cobb's angle (-6.85), scoliometer readings (-2.80), lumbar lordosis (4.23), and calcaneal valgus angles (left, -3.76; right, -2.83) regardless of the initial scoliosis angle, and within-group changes were significant ( p  < 0.001).","[""60 adolescent patients diagnosed with idiopathic scoliosis by a rehabilitation physician based on a Cobb's angle of ≥10° using total anteroposterior plain radiography"", 'patients with idiopathic scoliosis', ""Patients were classified into groups with a Cobb's angle of 10-19° (G1), 20-29° (G2), and ≥30° (G3"", 'Adolescent Patients with Idiopathic Scoliosis']","['SRE', 'Schroth Rehabilitation Exercise Program', 'Schroth rehabilitation exercises (SRE']","[""Cobb's angle, scoliometer readings, lumbar lordosis, and calcaneal valgus angles"", 'Spinal and Feet Alignment', ""SRE improved Cobb's angle (-6.85), scoliometer readings (-2.80), lumbar lordosis (4.23), and calcaneal valgus angles""]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0595995', 'cui_str': 'Idiopathic scoliosis'}, {'cui': 'C0586876', 'cui_str': 'Rehabilitation physician'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C1184923', 'cui_str': 'Lumbar hyperlordosis'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",60.0,0.017225,"RESULTS


SRE improved Cobb's angle (-6.85), scoliometer readings (-2.80), lumbar lordosis (4.23), and calcaneal valgus angles (left, -3.76; right, -2.83) regardless of the initial scoliosis angle, and within-group changes were significant ( p  < 0.001).","[{'ForeName': 'Jaeyong', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Institute of Sports Health Science, Sunmoon University, 70, Sunmoon-ro 221 beon-gil, Tangjeong-myeon, Asan-si 31460, Korea.'}, {'ForeName': 'Wi-Young', 'Initials': 'WY', 'LastName': 'So', 'Affiliation': 'Sport Medicine Major, College of Humanities and Arts, Korea National University of Transportation, Chungju-si 27469, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare10020398']
2420,35206980,The Effectiveness of Neroli Essential Oil in Relieving Anxiety and Perceived Pain in Women during Labor: A Randomized Controlled Trial.,"Childbirth is a stressful and physically painful event in a woman's life and aromatherapy is one of the most used non-pharmacological methods that is effective in reducing anxiety and perceived pain. This randomized controlled study aimed at determining the effect of neroli oil aromatherapy on anxiety and pain intensity perception in 88 women during labor, randomly assigned to either an intervention group ( n  = 44) or control group ( n  = 44). Anxiety and perceived pain were assessed through the visual analogue scale during the latent, early, and late active phases of labor. Data analyses included the  t -test, Chi-square test, and repeated measures ANOVA. Perceived pain and anxiety in the group receiving aromatherapy were significantly lower than in the control group at all stages of labor ( p  < 0.05). Specifically, as the labor progressed, pain and anxiety increased in all participants, but the increase was milder in the experimental group than in the control group. The multiparas showed higher average anxiety scores, but not perceived pain, than the primiparas in all phases of labor ( p  < 0.05). Ultimately, neroli oil aromatherapy during labor can be used as an alternative tool to relieve anxiety and perceived pain in women during all stages of labor.",2022,Perceived pain and anxiety in the group receiving aromatherapy were significantly lower than in the control group at all stages of labor ( p  < 0.05).,"['88 women during labor', 'Women during Labor']","['neroli oil aromatherapy', 'Neroli Essential Oil']","['Relieving Anxiety and Perceived Pain', 'average anxiety scores', 'Perceived pain and anxiety', 'Anxiety and perceived pain', 'anxiety and pain intensity perception', 'labor progressed, pain and anxiety']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022864', 'cui_str': 'Labor'}]","[{'cui': 'C0304111', 'cui_str': 'Orange flower oil'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C3255928', 'cui_str': 'CITRUS SINENSIS FLOWER OIL'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}]","[{'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]",88.0,0.0453311,Perceived pain and anxiety in the group receiving aromatherapy were significantly lower than in the control group at all stages of labor ( p  < 0.05).,"[{'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Scandurra', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, University of Naples Federico II, 80133 Naples, Italy.'}, {'ForeName': 'Selene', 'Initials': 'S', 'LastName': 'Mezzalira', 'Affiliation': 'Department of Humanistic Studies, University of Calabria, 87036 Rende, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cutillo', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, University of Naples Federico II, 80133 Naples, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Zapparella', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, University of Naples Federico II, 80133 Naples, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Statti', 'Affiliation': 'Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy.'}, {'ForeName': 'Nelson Mauro', 'Initials': 'NM', 'LastName': 'Maldonato', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, University of Naples Federico II, 80133 Naples, Italy.'}, {'ForeName': 'Mariavittoria', 'Initials': 'M', 'LastName': 'Locci', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, University of Naples Federico II, 80133 Naples, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Bochicchio', 'Affiliation': 'Department of Humanistic Studies, University of Calabria, 87036 Rende, Italy.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare10020366']
2421,35207534,Ex-Vivo Preservation with the Organ Care System in High Risk Heart Transplantation.,"OBJECTIVE


Ex vivo organ perfusion is an advanced preservation technique that allows graft assessment and extended ex situ intervals. We hypothesized that its properties might be especially beneficial for high-risk recipients and/or donors with extended criteria.
METHODS


We reviewed the outcomes of 119 consecutive heart transplant patients, which were divided into two groups: A (OCS) vs. B (conventional). Ex vivo organ perfusion was performed using the Organ Care System (OCS). Indications for OCS-usage were expected ischemic time of >4 h or >2 h plus given extended donor criteria.
RESULTS


Both groups included mostly redo cases (A: 89.7% vs. B: 78.4%;  p  = 0.121). Incidences of donors with previous cardiac arrest (%) (A: 32.4 vs. B: 22.2;  p  < 0.05) or LV-hypertrophy (%) (A: 19.1 vs. B: 8.3;  p  = 0.119) were also increased in Group A. Ex situ time (min) was significantly longer in Group A (A: 381 (74) vs. B: 228 (43);  p  < 0.05). Ventilation time (days) (A: 10.0 (19.9) vs. B: 24.3 (43.2);  p  = 0.057), postoperative need for ECLS (%) (A: 25.0 vs. B: 39.2;  p  = 0.112) and postoperative dialysis (chronic) (%) (A: 4.4 vs. B: 27.5;  p  < 0.001) were numerically better in the OCS group, without any difference in the occurrence of early graft rejection. The 30-d-survival (A: 92.4% vs. B: 90.2%;  p  = 0.745) and mid-term survival were statistically not different between both groups.
CONCLUSIONS


OCS heart allowed safe transplantation of surgically complex recipients with excellent one-year outcomes, despite long preservation times and unfavourable donor characteristics. Furthermore, we observed trends towards decreased ventilation times and fewer ECLS treatments. In times of reduced organ availability and increasing recipient complexity, OCS heart is a valuable instrument that enables otherwise infeasible allocations and contributes to increase surgical safety.",2022,"The 30-d-survival (A: 92.4% vs. B: 90.2%;  p  = 0.745) and mid-term survival were statistically not different between both groups.
","['High Risk Heart Transplantation', 'high-risk recipients and/or donors with extended criteria', '119 consecutive heart transplant patients']",['Ex-Vivo Preservation with the Organ Care System'],"['occurrence of early graft rejection', 'postoperative need for ECLS', '30-d-survival', 'Incidences of donors with previous cardiac arrest', 'Ventilation time (days', 'postoperative dialysis (chronic', 'ventilation times', 'mid-term survival', 'surgical safety', 'LV-hypertrophy']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018129', 'cui_str': 'Graft rejection'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0149721', 'cui_str': 'Left ventricular hypertrophy'}]",,0.0348664,"The 30-d-survival (A: 92.4% vs. B: 90.2%;  p  = 0.745) and mid-term survival were statistically not different between both groups.
","[{'ForeName': 'Sebastian V', 'Initials': 'SV', 'LastName': 'Rojas', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Avsar', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ius', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schibilsky', 'Affiliation': 'Department of Cardiovascular Surgery, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Kaufeld', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Benk', 'Affiliation': 'Department of Cardiovascular Surgery, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Maeding', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berchtold-Herz', 'Affiliation': 'Department of Cardiovascular Surgery, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bara', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Friedhelm', 'Initials': 'F', 'LastName': 'Beyersdorf', 'Affiliation': 'Department of Cardiovascular Surgery, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haverich', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Warnecke', 'Affiliation': 'Department of Cardiothoracic, Transplant and Vascular Surgery, Hannover Medical School, 30625 Hannover, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Siepe', 'Affiliation': 'Department of Cardiovascular Surgery, University of Freiburg, 79106 Freiburg, Germany.'}]","Life (Basel, Switzerland)",['10.3390/life12020247']
2422,35207489,Photobiomodulation for Lowering Pain after Tonsillectomy: Low Efficacy and a Possible Unexpected Adverse Effect.,"BACKGROUND


Tonsillectomy is one of the most common surgical procedures performed in children as a treatment for obstructive sleep apnea due to tonsil hypertrophy or highly recurrent tonsillitis. Odynophagia, associated with food refusal for the first few days, is a common post-operative complaint. Available drugs for pain management, while efficacious, present some drawbacks, and a novel strategy would be welcome. Photobiomodulation (PBMT), in this context, can represent a possible choice, together with pharmacological therapy. The aim of this study was to evaluate PBMT effects compared to standard pain therapy on nociceptive sensation at different time points and administration of painkiller.
METHODS


A registered, controlled, randomized, double-blind clinical trial was performed. Twenty-two patients were recruited and divided into laser-treated (T) or untreated (UT) groups, based on random assignment. In T group, immediately after tonsillectomy, performed with cold dissection technique, laser light was applied to the surgery site (using a Cube 4 from Eltech K-Laser s.r.l., Treviso, Italy), and then hemostasis was performed using bismuth subgallate paste. In C group, the same procedure was performed, except that laser light was switched off. The primary outcome was the difference in pain scores between subject receiving photobiomodulation (PBMT) and subjects receiving standard care after 24 h; the secondary outcomes were pain scores at awakening and at 48 h together with distress (delirium) at awakening.
RESULTS


Two patients from the T group experienced a post-surgery bleeding, and one of them required revision of the hemostasis under general anesthesia. A preliminary analysis of pain sensation reported by the patients or caregivers did not show differences between treated and untreated subjects.
CONCLUSION


These data suggest that PBMT could increase post-surgical bleeding.",2022,"A preliminary analysis of pain sensation reported by the patients or caregivers did not show differences between treated and untreated subjects.
",['Twenty-two patients were recruited and divided into'],"['cold dissection technique, laser light', 'laser-treated (T) or untreated (UT', 'standard pain therapy', 'PBMT', 'Photobiomodulation (PBMT', 'photobiomodulation (PBMT']","['nociceptive sensation', 'post-surgery bleeding', 'post-surgical bleeding', 'pain sensation', 'PBMT effects', 'pain scores', 'pain scores at awakening and at 48 h together with distress (delirium']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0458142', 'cui_str': 'Laser light'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]",22.0,0.105575,"A preliminary analysis of pain sensation reported by the patients or caregivers did not show differences between treated and untreated subjects.
","[{'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Celsi', 'Affiliation': 'Institute for Maternal and Child Health-IRCCS ""Burlo Garofolo"", 65/1 Via dell\'Istria, 34137 Trieste, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Staffa', 'Affiliation': 'Institute for Maternal and Child Health-IRCCS ""Burlo Garofolo"", 65/1 Via dell\'Istria, 34137 Trieste, Italy.'}, {'ForeName': 'Martino', 'Initials': 'M', 'LastName': 'Lamba', 'Affiliation': 'Institute for Maternal and Child Health-IRCCS ""Burlo Garofolo"", 65/1 Via dell\'Istria, 34137 Trieste, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Castro', 'Affiliation': 'Institute for Maternal and Child Health-IRCCS ""Burlo Garofolo"", 65/1 Via dell\'Istria, 34137 Trieste, Italy.'}, {'ForeName': 'Maddalena', 'Initials': 'M', 'LastName': 'Chermetz', 'Affiliation': 'Institute for Maternal and Child Health-IRCCS ""Burlo Garofolo"", 65/1 Via dell\'Istria, 34137 Trieste, Italy.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Orzan', 'Affiliation': 'Institute for Maternal and Child Health-IRCCS ""Burlo Garofolo"", 65/1 Via dell\'Istria, 34137 Trieste, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Sagredini', 'Affiliation': 'Institute for Maternal and Child Health-IRCCS ""Burlo Garofolo"", 65/1 Via dell\'Istria, 34137 Trieste, Italy.'}, {'ForeName': 'Egidio', 'Initials': 'E', 'LastName': 'Barbi', 'Affiliation': 'Institute for Maternal and Child Health-IRCCS ""Burlo Garofolo"", 65/1 Via dell\'Istria, 34137 Trieste, Italy.'}]","Life (Basel, Switzerland)",['10.3390/life12020202']
2423,35207474,Photobiomodulation Therapy Combined with Static Magnetic Field (PBMT-SMF) on Spatiotemporal and Kinematics Gait Parameters in Post-Stroke: A Pilot Study.,"BACKGROUND


Gait deficit is a major complaint in patients after stroke, restricting certain activities of daily living. Photobiomodulation therapy combined with a static magnetic field (PBMT-SMF) has been studied for several diseases, and the two therapies are beneficia. However, their combination has not yet been evaluated in stroke. Therefore, for PBMT-SMF to be used more often and become an adjunctive tool in the rehabilitation of stroke survivors at physical therapy rehabilitation centers and clinics, some important aspects need to be clarified.
PURPOSE


This study aimed to test different doses of PBMT-SMF, to identify the ideal dose to cause immediate effects on the spatiotemporal and kinematic variables of gait in post-stroke patients.
METHODS


A randomized, triple-blinded, placebo-controlled crossover pilot study was performed. A total of 10 individuals with hemiparesis within 6 months to 5 years since the occurrence of stroke, aged 45-60 years, were included in the study. Participants were randomly assigned and treated with a single PBMT-SMF dose (sham, 10 J, 30 J, or 50 J) on a single application, with one dose per stage at 7-day intervals between stages. PBMT-SMF was applied with a cluster of 12 diodes (4 of 905 nm laser, 4 of 875 nm LEDs, and 4 of 640 nm LEDs, SMF of 35 mT) at 17 sites on both lower limbs after baseline evaluation: plantar flexors (2), knee extensors (9), and flexors (6). The primary outcome was self-selected walking speed, and the secondary outcomes were kinematic parameters. Gait analysis was performed using SMART-D 140 ®  and SMART-D INTEGRATED WORKSTATION ® . The outcomes were measured at the end of each stage after the single application of each PBMT-SMF dose tested.
RESULTS


No significant differences ( p  > 0.05) in spatiotemporal variables were observed between the different doses, compared with the baseline evaluation. However, differences ( p  < 0.05) were observed in the kinematic variable of the hip in the paretic and non-paretic limbs, specifically in the minimum flexion/extension angulation during the support phase (HMST-MIN) in doses 10 J, 30 J, and 50 J.
CONCLUSIONS


A single application of PBMT-SMF at doses of 10 J, 30 J, and 50 J per site of the lower limbs did not demonstrate positive effects on the spatiotemporal variables, but it promoted immediate effects in the kinematic variables of the hip (maximum and minimum flexion/extension angulation during the support phase) in the paretic and non-paretic limbs in post-stroke people.",2022,"However, differences ( p  < 0.05) were observed in the kinematic variable of the hip in the paretic and non-paretic limbs, specifically in the minimum flexion/extension angulation during the support phase (HMST-MIN) in doses 10 J, 30 J, and 50 J.
CONCLUSIONS


","['post-stroke patients', '10 individuals with hemiparesis within 6 months to 5 years since the occurrence of stroke, aged 45-60 years', 'Post-Stroke']","['Photobiomodulation therapy combined with a static magnetic field (PBMT-SMF', 'placebo', 'PBMT-SMF', 'Photobiomodulation Therapy Combined with Static Magnetic Field (PBMT-SMF', 'single PBMT-SMF']","['Spatiotemporal and Kinematics Gait Parameters', 'self-selected walking speed']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0563533', 'cui_str': 'Magnetic field'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",10.0,0.0730669,"However, differences ( p  < 0.05) were observed in the kinematic variable of the hip in the paretic and non-paretic limbs, specifically in the minimum flexion/extension angulation during the support phase (HMST-MIN) in doses 10 J, 30 J, and 50 J.
CONCLUSIONS


","[{'ForeName': 'Arislander Jonathan Lopes', 'Initials': 'AJL', 'LastName': 'Dumont', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Post-Graduated Program in Rehabilitation Sciences, U Nove de Julho University (UNINOVE), São Paulo 01525-000, Brazil.'}, {'ForeName': 'Heliodora Leão', 'Initials': 'HL', 'LastName': 'Casalechi', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Post-Graduated Program in Rehabilitation Sciences, U Nove de Julho University (UNINOVE), São Paulo 01525-000, Brazil.'}, {'ForeName': 'Shaiane Silva', 'Initials': 'SS', 'LastName': 'Tomazoni', 'Affiliation': 'Physiotherapy Research Group, Department of Global Public Health and Public Care, University of Bergen (UiB), 5020 Bergen, Norway.'}, {'ForeName': 'Luanda Collange', 'Initials': 'LC', 'LastName': 'Grecco', 'Affiliation': 'Vento Leste-Specialized Childcare Habilitation, Sorocaba 18046-715, Brazil.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': 'Department of Electronic Information and Bioengineering, Politecnico di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Claudia Santos', 'Initials': 'CS', 'LastName': 'Oliveira', 'Affiliation': 'Health Sciences Program, Santa Casa de São Paulo School of Medical Sciences, São Paulo 01221-020, Brazil.'}, {'ForeName': 'Ernesto Cesar Pinto', 'Initials': 'ECP', 'LastName': 'Leal-Junior', 'Affiliation': 'Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Post-Graduated Program in Rehabilitation Sciences, U Nove de Julho University (UNINOVE), São Paulo 01525-000, Brazil.'}]","Life (Basel, Switzerland)",['10.3390/life12020186']
2424,35207466,"Effect of Combined Balance Exercises and Kinesio Taping on Balance, Postural Stability, and Severity of Ankle Instability in Female Athletes with Functional Ankle Instability.","Ankle sprain is a common musculoskeletal injury, and recurrent ankle sprains often lead to ankle instability. This study aimed to examine whether a 6-week balance training on a wobble board (WB) combined with kinesio taping (KT) is effective in improving balance, postural stability, and ankle stability among female athletes with functional ankle instability (FAI). Twenty-four female athletes with FAI were randomly assigned to study (SG) or control groups (CG). SG attended a 6-week training protocol of combined balance training on the wobble board with KT applied to ankles during exercise. CG only went through a 6-week balance training procedure that was the same as the SG. Before and after the training program, balance and postural stability and the severity of ankle instability were assessed by single-leg Biodex Balance system and Cumberland Ankle Instability Tool (CAIT), respectively. The analysis revealed that the scores of balance and postural stability decreased after the 6-week training for CG ( p  = 0.002) and SG ( p  = 0.001), which indicates an improvement for these variables, and the score of CAIT increased, which means the severity of instability reduced ( p  = 0.001 for both groups). Significant between-group differences were found for balance and postural stability ( t  = 2.79,  p  = 0.011,  g  = -1.99) and the severity of instability ( t  = 2.082,  p  = 0.049,  g  = 1.36), favoring SG compared with CG. This study showed that the addition of KT to balance training is more effective than balance training alone in improving balance, postural stability, and severity of ankle instability in female athletes with FAI. Our findings could provide a preliminary reference for designing combined balance and KT programs for delivering health benefits to females with FAI.",2022,"Significant between-group differences were found for balance and postural stability ( t  = 2.79,  ","['female athletes with functional ankle instability (FAI', 'Female Athletes with Functional Ankle Instability', 'female athletes with FAI', 'females with FAI', 'Twenty-four female athletes with FAI']","['wobble board (WB) combined with kinesio taping (KT', 'Combined Balance Exercises and Kinesio Taping', 'balance training']","['severity of instability', 'balance, postural stability, and ankle stability', 'Balance, Postural Stability, and Severity of Ankle Instability', 'score of CAIT', 'scores of balance and postural stability', 'balance and postural stability', 'balance, postural stability, and severity of ankle instability', 'balance and postural stability and the severity of ankle instability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0576206', 'cui_str': 'Stability of ankle'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]",24.0,0.0132126,"Significant between-group differences were found for balance and postural stability ( t  = 2.79,  ","[{'ForeName': 'Sara Mahmoudzadeh', 'Initials': 'SM', 'LastName': 'Khalili', 'Affiliation': 'Department of Health and Sport Rehabilitation, Faculty of Sport Sciences & Health, Shahid Beheshti University, Tehran 19839-69411, Iran.'}, {'ForeName': 'Amir Hossein', 'Initials': 'AH', 'LastName': 'Barati', 'Affiliation': 'Department of Health and Sport Rehabilitation, Faculty of Sport Sciences & Health, Shahid Beheshti University, Tehran 19839-69411, Iran.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Oliveira', 'Affiliation': 'Sports Science School of Rio Maior-Polytechnic Institute of Santarém, Av. Dr. Mário Soares, 2040-413 Rio Maior, Portugal.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Nobari', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}]","Life (Basel, Switzerland)",['10.3390/life12020178']
2425,35216619,"Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction-BAMPI TRIAL: an open-label, randomized controlled trial protocol.","BACKGROUND


It is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing meal stent (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency. The aim of this study is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (BD) for the management of distal malignant biliary obstruction.
METHODS/DESIGN


This is a multicenter open-label, randomized controlled trial with two parallel groups. Eighty-four patients with malignant biliary obstruction will undergo EUS-BD (CDS type) using LAMS in 7 tertiary hospitals in Spain and will be randomized to the LAMS and LAMS plus DPS groups. The primary endpoint is the rate of recurrent biliary obstruction, as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin > 50% within 14 days of stent placement), safety, and others (number of reinterventions, time to biliary obstruction, prognostic factors, survival rate).
DISCUSSION


The BAMPI trial has been designed to determine whether the addition of a coaxial axis-orienting DPS through LAMS is superior to LAMS alone to prevent stent dysfunction.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04595058 . Registered on October 14, 2020.",2022,"Secondary endpoints: technical and clinical success (reduction in bilirubin > 50% within 14 days of stent placement), safety, and others (number of reinterventions, time to biliary obstruction, prognostic factors, survival rate).
",['Eighty-four patients with malignant biliary obstruction will undergo EUS-BD (CDS type) using LAMS in 7 tertiary hospitals in Spain'],"['lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage', 'axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing meal stent (LAMS) in EUS-guided choledochoduodenostomy (CDS', 'EUS-guided biliary drainage (BD']","['technical and clinical success (reduction in bilirubin >\u200950% within 14\u2009days of stent placement), safety, and others (number of reinterventions, time to biliary obstruction, prognostic factors, survival rate', 'rate of recurrent biliary obstruction, as a stent dysfunction parameter']","[{'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3898473', 'cui_str': 'Malignant biliary obstruction'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}, {'cui': 'C0008342', 'cui_str': 'Choledochoduodenostomy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0441290', 'cui_str': 'Metal stent'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0008342', 'cui_str': 'Choledochoduodenostomy'}]","[{'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0400979', 'cui_str': 'Obstruction of biliary tree'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",84.0,0.223071,"Secondary endpoints: technical and clinical success (reduction in bilirubin > 50% within 14 days of stent placement), safety, and others (number of reinterventions, time to biliary obstruction, prognostic factors, survival rate).
","[{'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Garcia-Sumalla', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain.'}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Loras', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari Mútua Terrassa, Fundació per la Recerca Mútua Terrassa, CIBERehd, Terrassa, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Sanchiz', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases, Hospital Clínico Universitario de Valencia, Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain.'}, {'ForeName': 'Rafael Pedraza', 'Initials': 'RP', 'LastName': 'Sanz', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases Endoscopy Unit, Hospital General Universitario de Castellón, Castelló de la Plana, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Vazquez-Sequeiros', 'Affiliation': 'Endoscopy Unit, Gastroenterology and Hepatology Service, Hospital Ramon y Cajal, IRYCIS, Madrid, Spain.'}, {'ForeName': 'Jose Ramon', 'Initials': 'JR', 'LastName': 'Aparicio', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases, Hospital General Universitario de Alicante; Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'de la Serna-Higuera', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases, Hospital Universitario Rio Hortega, Valladolid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Luna-Rodriguez', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Andujar', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari Mútua Terrassa, Fundació per la Recerca Mútua Terrassa, CIBERehd, Terrassa, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Capilla', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases, Hospital Clínico Universitario de Valencia, Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Barberá', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases Endoscopy Unit, Hospital General Universitario de Castellón, Castelló de la Plana, Spain.'}, {'ForeName': 'Jose Ramon', 'Initials': 'JR', 'LastName': 'Foruny-Olcina', 'Affiliation': 'Endoscopy Unit, Gastroenterology and Hepatology Service, Hospital Ramon y Cajal, IRYCIS, Madrid, Spain.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Martínez', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases, Hospital General Universitario de Alicante; Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Dura', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases, Hospital Universitario Rio Hortega, Valladolid, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Salord', 'Affiliation': 'Hepato-Bilio-Pancreatic Unit, Digestive Diseases Department, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain.'}, {'ForeName': 'Berta', 'Initials': 'B', 'LastName': 'Laquente', 'Affiliation': 'Clinical Oncology Department, Hospital Duran y Reynalds, Institu Oncologic de Catalunya, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Tebe', 'Affiliation': 'Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain.'}, {'ForeName': 'Sebastia', 'Initials': 'S', 'LastName': 'Videla', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Perez-Miranda', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases, Hospital General Universitario de Alicante; Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain.'}, {'ForeName': 'Joan B', 'Initials': 'JB', 'LastName': 'Gornals', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain. jgornals@bellvitgehospital.cat.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-022-06106-1']
2426,35206825,Neurogenic Bowel Dysfunction Changes after Osteopathic Care in Individuals with Spinal Cord Injuries: A Preliminary Randomized Controlled Trial.,"BACKGROUND


Neurogenic bowel dysfunction (NBD) indicates bowel dysfunction due to a lack of nervous control after a central nervous system lesion. Bowel symptoms, such as difficulties with evacuation, constipation, abdominal pain and swelling, are experienced commonly among individuals with spinal cord injury (SCI). Consequentially, individuals with SCI experience a general dissatisfaction with the lower perceived quality of life (QoL). Several studies have demonstrated the positive effects of manual therapies on NBD, including Osteopathic Manipulative Treatment (OMT). This study aimed to explore OMT effects on NBD in individuals with SCI compared with Manual Placebo Treatment (MPT).
METHODS


The study was a double-blind randomized controlled trial composed of three phases, each one lasting 30 days (i: NBD/drugs monitoring; ii: four OMT/MPT sessions; iii: NBD/drug monitoring and follow-up evaluation).
RESULTS


the NBD scale, the QoL on worries and concerns sub-questionnaire, and the perception of abdominal swelling and constipation significantly improved after treatments compared to baseline only for individuals who underwent OMT.
CONCLUSION


These preliminary results showed positive effects of OMT on bowel function and QoL in individuals with SCI, but further studies are needed to confirm our results.",2022,"RESULTS


the NBD scale, the QoL on worries and concerns sub-questionnaire, and the perception of abdominal swelling and constipation significantly improved after treatments compared to baseline only for individuals who underwent OMT.
","['Individuals with Spinal Cord Injuries', 'individuals with spinal cord injury (SCI', 'individuals with SCI', 'Treatment (MPT']","['Osteopathic Care', 'OMT', 'Manual Placebo']","['QoL on worries and concerns sub-questionnaire, and the perception of abdominal swelling and constipation', 'quality of life (QoL']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0419203', 'cui_str': 'Osteopathy'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",,0.208865,"RESULTS


the NBD scale, the QoL on worries and concerns sub-questionnaire, and the perception of abdominal swelling and constipation significantly improved after treatments compared to baseline only for individuals who underwent OMT.
","[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Tamburella', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina 306, 00179 Rome, Italy.'}, {'ForeName': 'Alessandro Antonio', 'Initials': 'AA', 'LastName': 'Princi', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina 306, 00179 Rome, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Piermaria', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina 306, 00179 Rome, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lorusso', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina 306, 00179 Rome, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Scivoletto', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina 306, 00179 Rome, Italy.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Masciullo', 'Affiliation': 'Neurology and Neurovascular Treatment Unit, Belcolle Hospital, Str. Sammartinese, 01100 Viterbo, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cardilli', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina 306, 00179 Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Argentieri', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina 306, 00179 Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tramontano', 'Affiliation': 'Santa Lucia Foundation IRCCS, Via Ardeatina 306, 00179 Rome, Italy.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare10020210']
2427,35207238,Efficacy and Safety of the Hexanic Extract of  Serenoa repens  vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Study.,"We investigated changes in symptoms and quality of life (QoL) in men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving the hexanic extract of  Serenoa &nbsp; repens  (HESr) and compared results with a matched group on watchful waiting (WW). Data was from a real-world, open-label, prospective, multicenter study. This sub-group analysis included patients with moderate-to-severe symptoms receiving either the HESr 320 mg/daily for six months (HESr) or who remained untreated for LUTS/BPH (WW). Changes in urinary symptoms and QoL were measured by IPSS and BII questionnaires. Two statistical approaches (iterative matching and propensity score pairing) were used to maximize between-group comparability at baseline. Tolerability was assessed in the HESr group. After iterative matching, data for analysis was available for 783 patients (102 WW, 681 HESr). IPSS scores improved by a mean (SD) of 3.8 (4.4) points in the HESr group and by 2.2 (4.5) points in the WW group ( p  = 0.002). Changes in BII score were 1.8 (2.4) points and 1.0 (2.2) points, respectively ( p  < 0.001). Three patients (0.9%) treated with the HESr reported mild adverse effects. Moderate-severe LUTS/BPH patients treated for six months with the HESr showed greater improvements in symptoms and QoL than matched patients on WW, with a very low rate of adverse effects.",2022,"Moderate-severe LUTS/BPH patients treated for six months with the HESr showed greater improvements in symptoms and QoL than matched patients on WW, with a very low rate of adverse effects.","['men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving the hexanic extract of  Serenoa &nbsp; repens  (HESr) and compared results with a matched group on watchful waiting (WW', 'patients with moderate-to-severe symptoms receiving either the HESr 320 mg/daily for six months (HESr) or who remained untreated for LUTS/BPH (WW', '783 patients (102 WW, 681 HESr', 'Men with Moderate to Severe LUTS-BPH']",['Hexanic Extract of  Serenoa repens  vs. Watchful Waiting'],"['mild adverse effects', 'Tolerability', 'urinary symptoms and QoL', 'IPSS scores', 'Efficacy and Safety', 'Changes in BII score', 'symptoms and quality of life (QoL', 'symptoms and QoL']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0771607', 'cui_str': 'Saw palmetto extract'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0697222', 'cui_str': 'Sabal serrulata'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0400936,"Moderate-severe LUTS/BPH patients treated for six months with the HESr showed greater improvements in symptoms and QoL than matched patients on WW, with a very low rate of adverse effects.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Alcaraz', 'Affiliation': 'Urology Department, Hospital Clínic, Universitat de Barcelona, IDIBAPS, 08036 Barcelona, Spain.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Gacci', 'Affiliation': 'Unit of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, Careggi University Hospital (AOUC), University of Florence, 50134 Florence, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Ficarra', 'Affiliation': 'Department of Human and Pediatric Pathology ""Gaetano Barresi"", Urology Section, University of Messina, 98125 Messina, Italy.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Medina-Polo', 'Affiliation': 'Urology Department, Research Institute Hospital 12 de Octubre (i+12), 28041 Madrid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Salonia', 'Affiliation': 'Division of Experimental Oncology, URI, IRCCS Ospedale San Raffaele, University Vita-Salute San Raffaele, 20132 Milan, Italy.'}, {'ForeName': 'Jesús M', 'Initials': 'JM', 'LastName': 'Fernández-Gómez', 'Affiliation': 'Urology Department, Hospital Universitario Central de Asturias, 33011 Oviedo, Spain.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Ciudin', 'Affiliation': 'Urology Department, Hospital de Mollet, 08100 Mollet, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Castro-Díaz', 'Affiliation': 'Urology Department, Hospital Universitario de Canarias, 38320 Tenerife, Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Rodríguez-Antolín', 'Affiliation': 'Urology Department, Research Institute Hospital 12 de Octubre (i+12), 28041 Madrid, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Carballido-Rodríguez', 'Affiliation': 'Urology Department, Hospital Universitario Puerta de Hierro Majadahonda, 28222 Majadahonda, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Cózar-Olmo', 'Affiliation': 'Urology Department, Hospital Universitario Virgen de las Nieves, 18014 Granada, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Búcar-Terrades', 'Affiliation': 'Urology Department, Hospital El Pilar, Quirón Salud, 08006 Barcelona, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Pérez-León', 'Affiliation': 'Gran Sol Primary Care Center, 08914 Badalona, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Brenes-Bermúdez', 'Affiliation': 'SEMERGEN Nefro-Urology Working Group, 08338 Premià de Dalt, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Molero-García', 'Affiliation': 'San Andrés Primary Care Center, 28021 Madrid, Spain.'}, {'ForeName': 'Antonio Fernández-Pro', 'Initials': 'AF', 'LastName': 'Ledesma', 'Affiliation': 'Menasalbas Primary Care Center, 45128 Toledo, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Herdman', 'Affiliation': 'Insight Consulting and Research, 08301 Mataró, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Manasanch', 'Affiliation': 'Pierre Fabre Ibérica S.A., 08005 Barcelona, Spain.'}, {'ForeName': 'Javier C', 'Initials': 'JC', 'LastName': 'Angulo', 'Affiliation': 'Clinical Department, Universidad Europea de Madrid, 28905 Getafe, Spain.'}, {'ForeName': 'On Behalf Of The Qualiprost Study', 'Initials': 'OBOTQS', 'LastName': 'Group', 'Affiliation': ''}]",Journal of clinical medicine,['10.3390/jcm11040967']
2428,35207224,"rTMS Reduces Craving and Alcohol Use in Patients with Alcohol Use Disorder: Results of a Randomized, Sham-Controlled Clinical Trial.","(1) Background: Current evidence-based treatments for alcohol use disorder (AUD) are moderately effective. Studies testing repetitive transcranial magnetic stimulation (rTMS) in AUD commonly apply a limited number of rTMS sessions with different rTMS settings, showing inconsistent effects on craving for alcohol. This study tested the efficacy of a robust rTMS protocol on craving and alcohol use. (2) Methods: In a single-blind randomized controlled trial in recently detoxified patients with AUD, ten days of high-frequency rTMS over the right dorsolateral prefrontal cortex on top of treatment as usual ( n  = 14) was compared with sham rTMS ( n  = 16). Outcome measures were alcohol craving and use over a follow-up period of one year. Analysis was performed by means of repeated measures multivariate analysis of variance. (3) Results: The results showed a main group-by-time interaction effect on craving (Wilks' Λ = 0.348, F (12, 17) = 2.654,  p  = 0.032) and an effect of group on alcohol use (Wilk's Λ = 0.44, F (6, 23) = 4.9,  p  = 0.002), with lower alcohol craving and use in the group with active rTMS compared to the control group. Differences in craving between groups were most prominent three months after treatment. At 12 months follow-up, there was no effect of rTMS on craving or abstinence. (4) Conclusions: This small-scale randomized controlled trial showed the efficacy of high-frequency rTMS over the right dlPFC diminished alcohol craving and use in recently detoxified patients with AUD during the first months after detoxification. These findings suggest that rTMS might be an effective add-on in treating patients with AUD and warrant replication in future large-scale studies.",2022,"At 12 months follow-up, there was no effect of rTMS on craving or abstinence.","['Patients with Alcohol Use Disorder', 'detoxified patients with AUD during the first months after detoxification', 'detoxified patients with AUD, ten days of high-frequency rTMS over the right dorsolateral prefrontal cortex on top of treatment as usual ( n  = 14']","['sham rTMS', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'robust rTMS protocol']","['alcohol craving and use over a follow-up period of one year', 'alcohol craving', 'Craving and Alcohol Use', 'craving or abstinence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.0197243,"At 12 months follow-up, there was no effect of rTMS on craving or abstinence.","[{'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Belgers', 'Affiliation': 'IrisZorg, Center for Addiction Care and Sheltered Housing, Mr. B.M. Teldersstraat 7, 6842 CT Arnhem, The Netherlands.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Van Eijndhoven', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, The Netherlands.'}, {'ForeName': 'Wiebren', 'Initials': 'W', 'LastName': 'Markus', 'Affiliation': 'IrisZorg, Center for Addiction Care and Sheltered Housing, Mr. B.M. Teldersstraat 7, 6842 CT Arnhem, The Netherlands.'}, {'ForeName': 'Aart H', 'Initials': 'AH', 'LastName': 'Schene', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, The Netherlands.'}, {'ForeName': 'Arnt', 'Initials': 'A', 'LastName': 'Schellekens', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, The Netherlands.'}]",Journal of clinical medicine,['10.3390/jcm11040951']
2429,35207174,Circulating SPINT1 Is Reduced in a Preeclamptic Cohort with Co-Existing Fetal Growth Restriction.,"Fetal growth restriction (FGR), when undetected antenatally, is the biggest risk factor for preventable stillbirth. Maternal circulating SPINT1 is reduced in pregnancies, which ultimately deliver small for gestational age (SGA) infants at term (birthweight < 10th centile), compared to appropriate for gestational age (AGA) infants (birthweight ≥ 10th centile). SPINT1 is also reduced in FGR diagnosed before 34 weeks' gestation. We hypothesised that circulating SPINT1 would be decreased in co-existing preterm preeclampsia and FGR. Plasma SPINT1 was measured in samples obtained from two double-blind, randomised therapeutic trials. In the Preeclampsia Intervention with Esomeprazole trial, circulating SPINT1 was decreased in women with preeclampsia who delivered SGA infants ( n  = 75, median = 18,857 pg/mL, IQR 10,782-29,890 pg/mL,  p  < 0.0001), relative to those delivering AGA ( n  = 22, median = 40,168 pg/mL, IQR 22,342-75,172 pg/mL). This was confirmed in the Preeclampsia Intervention 2 with metformin trial where levels of SPINT1 in maternal circulation were reduced in SGA pregnancies ( n  = 95, median = 57,764 pg/mL, IQR 42,212-91,356 pg/mL,  p  < 0.0001) compared to AGA controls ( n  = 40, median = 107,062 pg/mL, IQR 70,183-176,532 pg/mL). Placental Growth Factor (PlGF) and sFlt-1 were also measured. PlGF was significantly reduced in the SGA pregnancies, while ratios of sFlt-1/SPINT1 and sFlt1/PlGF were significantly increased. This is the first study to demonstrate significantly reduced SPINT1 in co-existing FGR and preeclamptic pregnancies.",2022,"Maternal circulating SPINT1 is reduced in pregnancies, which ultimately deliver small for gestational age (SGA) infants at term (birthweight < 10th centile), compared to appropriate for gestational age (AGA) infants (birthweight ≥ 10th centile).",[],['Esomeprazole'],"['ratios of sFlt-1/SPINT1 and sFlt1/PlGF', 'Placental Growth Factor (PlGF) and sFlt-1', 'Fetal growth restriction (FGR', 'levels of SPINT1 in maternal circulation', 'PlGF']",[],"[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1313526', 'cui_str': ""2',3'-dideoxy-3'-fluoro-2-thiothymidine""}, {'cui': 'C0138514', 'cui_str': 'Placenta Growth Factor'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C1504871', 'cui_str': 'PGF protein, human'}]",,0.144748,"Maternal circulating SPINT1 is reduced in pregnancies, which ultimately deliver small for gestational age (SGA) infants at term (birthweight < 10th centile), compared to appropriate for gestational age (AGA) infants (birthweight ≥ 10th centile).","[{'ForeName': 'Ciara N', 'Initials': 'CN', 'LastName': 'Murphy', 'Affiliation': 'Department of Obstetrics & Gynaecology, Mercy Hospital for Women, The University of Melbourne, Heidelberg, VIC 3084, Australia.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Cluver', 'Affiliation': 'Mercy Perinatal, Mercy Hospital for Women, Heidelberg, VIC 3084, Australia.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Walker', 'Affiliation': 'Department of Obstetrics & Gynaecology, Mercy Hospital for Women, The University of Melbourne, Heidelberg, VIC 3084, Australia.'}, {'ForeName': 'Emerson', 'Initials': 'E', 'LastName': 'Keenan', 'Affiliation': 'Department of Obstetrics & Gynaecology, Mercy Hospital for Women, The University of Melbourne, Heidelberg, VIC 3084, Australia.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Hastie', 'Affiliation': 'Department of Obstetrics & Gynaecology, Mercy Hospital for Women, The University of Melbourne, Heidelberg, VIC 3084, Australia.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'MacDonald', 'Affiliation': 'Department of Obstetrics & Gynaecology, Mercy Hospital for Women, The University of Melbourne, Heidelberg, VIC 3084, Australia.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Hannan', 'Affiliation': 'Department of Obstetrics & Gynaecology, Mercy Hospital for Women, The University of Melbourne, Heidelberg, VIC 3084, Australia.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Brownfoot', 'Affiliation': 'Department of Obstetrics & Gynaecology, Mercy Hospital for Women, The University of Melbourne, Heidelberg, VIC 3084, Australia.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Cannon', 'Affiliation': 'Department of Obstetrics & Gynaecology, Mercy Hospital for Women, The University of Melbourne, Heidelberg, VIC 3084, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Tong', 'Affiliation': 'Department of Obstetrics & Gynaecology, Mercy Hospital for Women, The University of Melbourne, Heidelberg, VIC 3084, Australia.'}, {'ForeName': ""Tu'uhevaha J"", 'Initials': 'TJ', 'LastName': ""Kaitu'u-Lino"", 'Affiliation': 'Department of Obstetrics & Gynaecology, Mercy Hospital for Women, The University of Melbourne, Heidelberg, VIC 3084, Australia.'}]",Journal of clinical medicine,['10.3390/jcm11040901']
2430,35207540,Effects of Wearing a 50% Lower Jaw Advancement Splint on Biophysical and Perceptual Responses at Low to Severe Running Intensities.,"Acute ergogenic effects of wearing occlusal splints have been reported for aerobic and anaerobic exercises, but the literature centered on performance improvement by using jaw repositioning splints is scarce. We aimed to analyze the effect of wearing a 50% lower jaw advancement splint on biophysical and perceptual responses at low to severe running intensities. Sixteen middle- and long-distance runners performed twice a 7 × 800 m intermittent running protocol (with 1 km·h -1  increments and 30 s rest periods) in an outdoor track field using two lower intraoral splints (a placebo and a lower jaw advancer). These devices were custom manufactured for each participant and a randomized and repeated measure design was used to compare conditions. No differences between placebo and lower jaw advancer were found (e.g., 52.1 ± 9.9 vs. 53.9 ± 10.7 mL·kg -1 ·min -1  of oxygen uptake, 3.30 ± 0.44 vs. 3.29 ± 0.43 m of stride length and 16 ± 3 vs. 16 ± 2 Borg scores), but small effects were sometimes observed (e.g., 109.2 ± 22.5 vs. 112.7 ± 25.2 L·min -1  of ventilation, ES = -0.42). Therefore, this jaw advancement splint had no substantial ergogenic effect on biophysical and perceptual responses when running at different intensities.",2022,"Therefore, this jaw advancement splint had no substantial ergogenic effect on biophysical and perceptual responses when running at different intensities.",[],"['wearing a 50% lower jaw advancement splint', 'Wearing a 50% Lower Jaw Advancement Splint', 'intermittent running protocol (with 1 km·h -1  increments and 30 s rest periods) in an outdoor track field using two lower intraoral splints (a placebo', 'placebo']","['Biophysical and Perceptual Responses', 'lower jaw advancer', 'biophysical and perceptual responses']",[],"[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0040595', 'cui_str': 'Track and field'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005553', 'cui_str': 'Biophysics'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}]",,0.0658875,"Therefore, this jaw advancement splint had no substantial ergogenic effect on biophysical and perceptual responses when running at different intensities.","[{'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': 'Centre of Research, Education, Innovation and Intervention in Sport, CIFI2D, Faculty of Sport, University of Porto, 4200-450 Porto, Portugal.'}, {'ForeName': 'Ana S', 'Initials': 'AS', 'LastName': 'Monteiro', 'Affiliation': 'Centre of Research, Education, Innovation and Intervention in Sport, CIFI2D, Faculty of Sport, University of Porto, 4200-450 Porto, Portugal.'}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Vilas-Boas', 'Affiliation': 'Centre of Research, Education, Innovation and Intervention in Sport, CIFI2D, Faculty of Sport, University of Porto, 4200-450 Porto, Portugal.'}, {'ForeName': 'João Carlos', 'Initials': 'JC', 'LastName': 'Pinho', 'Affiliation': 'Faculty of Dental Medicine, University of Porto, 4200-393 Porto, Portugal.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Pyne', 'Affiliation': 'Research Institute for Sport & Exercise, University of Canberra, Canberra 2617, Australia.'}, {'ForeName': 'Ricardo J', 'Initials': 'RJ', 'LastName': 'Fernandes', 'Affiliation': 'Centre of Research, Education, Innovation and Intervention in Sport, CIFI2D, Faculty of Sport, University of Porto, 4200-450 Porto, Portugal.'}]","Life (Basel, Switzerland)",['10.3390/life12020253']
2431,35208268,Effect of Supplementation with Olive Leaf Extract Enriched with Oleuropein on the Metabolome and Redox Status of Athletes' Blood and Urine-A Metabolomic Approach.,"Oleuropein (OE) is a secoiridoid glycoside occurring mostly in the Oleaceae family and presenting several pharmacological properties, including hypolipidemic and antioxidant properties. Based on these, several dietary supplements containing olive leaf extracts enriched with OE are commercially available in many countries. The current study aimed to examine the effect of supplementation with such an extract on the serum and urine metabolome of young healthy male athletes. For this purpose, applying a randomized, balanced, double-blind study, nine young, healthy males (physical education students) received either a commercially prepared extract or placebo for one week, followed by a two-week washout period; then, they were subsequently dosed with the alternate scheme (crossover design). Urine and serum samples were analyzed using UHPLC-HRMS, followed by evaluation with several multivariate methods of data analysis. The data were interpreted using a multilevel metabolomic approach (multilevel-sPLSDA) as it was found to be the most efficient approach for the study design. Metabolic pathway analysis of the most affected metabolites revealed that tryptophan and acylcarnitine's biochemistries were most influenced. Furthermore, several metabolites connected to indole metabolism were detected, which may indicate enhanced serotonin turnover. Phenylethylamine and related metabolites, as well as estrone, were connected to enhanced performance. In addition, possible changes to the lipidemic profile and the blood and urine redox statuses were investigated.",2022,The data were interpreted using a multilevel metabolomic approach (multilevel-sPLSDA) as it was found to be the most efficient approach for the study design.,"['nine young, healthy males (physical education students', 'young healthy male athletes']","['commercially prepared extract or placebo', 'Phenylethylamine', 'Supplementation with Olive Leaf Extract Enriched with Oleuropein', 'Oleuropein (OE', 'supplementation with such an extract']","['lipidemic profile and the blood and urine redox statuses', ""Metabolome and Redox Status of Athletes' Blood and Urine-A Metabolomic Approach""]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C4082130', 'cui_str': 'Prepared'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031399', 'cui_str': 'Phenylethylamines'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1364955', 'cui_str': 'Olive Leaf Extract'}, {'cui': 'C0069413', 'cui_str': 'oleuropein'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",9.0,0.0616008,The data were interpreted using a multilevel metabolomic approach (multilevel-sPLSDA) as it was found to be the most efficient approach for the study design.,"[{'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Lemonakis', 'Affiliation': 'Department of Pharmacognosy and Natural Products Chemistry, Faculty of Pharmacy, National and Kapodistrian University of Athens, Panepistimioupolis Zografou, 157 71 Athens, Greece.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Mougios', 'Affiliation': 'Laboratory of Evaluation of Human Biological Performance, School of Physical Education and Sport Science, Aristotle University of Thessaloniki, 541 24 Thessaloniki, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Halabalaki', 'Affiliation': 'Department of Pharmacognosy and Natural Products Chemistry, Faculty of Pharmacy, National and Kapodistrian University of Athens, Panepistimioupolis Zografou, 157 71 Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Dagla', 'Affiliation': 'The Goulandris Natural History Museum, Bioanalytical Laboratory, GAIA Research Center, 145 62 Kifissia, Greece.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Tsarbopoulos', 'Affiliation': 'The Goulandris Natural History Museum, Bioanalytical Laboratory, GAIA Research Center, 145 62 Kifissia, Greece.'}, {'ForeName': 'Alexios-Leandros', 'Initials': 'AL', 'LastName': 'Skaltsounis', 'Affiliation': 'Department of Pharmacognosy and Natural Products Chemistry, Faculty of Pharmacy, National and Kapodistrian University of Athens, Panepistimioupolis Zografou, 157 71 Athens, Greece.'}, {'ForeName': 'Evagelos', 'Initials': 'E', 'LastName': 'Gikas', 'Affiliation': 'Laboratory of Analytical Chemistry, Faculty of Chemistry, National and Kapodistrian University of Athens, Panepistimioupolis Zografou, 157 71 Athens, Greece.'}]",Metabolites,['10.3390/metabo12020195']
2432,35208561,Clinical Assessment of the Hyperbaric Oxygen Therapy Efficacy in Mild to Moderate Periodontal Affections: A Simple Randomised Trial.,"Background and Objectives:  Gum disease represents the condition due to the dental plaque and dental calculus deposition on the surfaces of the teeth, followed by ulterior destruction of the periodontal tissues through the host reaction to the pathogenic microorganisms. The aim of study was to present aspects regarding the efficacy of hyperbaric oxygen therapy (HBOT) as an adjuvant therapy for the treatment of periodontal disease, started from the already certified benefits of HBOT in the general medicine specialties.  Materials and Methods:  The participant patients in this study (71) required and benefited from specific periodontal disease treatments. All patients included in the trial benefited from the conventional therapy of full-mouth scaling and root planing (SRP) within 24 h. HBOT was performed on the patients of the first group (31), in 20 sessions, of one hour. The patients of the control group (40) did not benefit from HBO therapy.  Results:  At the end of study, the included patients in HBOT group presented significantly better values of oral health index (OHI-S), sulcus bleeding index (SBI), dental mobility (DM), and periodontal pocket depth (PD) than the patients of the control group.  Conclusions:  HBOT had beneficial effects on the oral and general health of all patients, because in addition to the positive results in periodontal therapy, some individual symptoms of the patients diminished or disappeared upon completion of this adjuvant therapy.",2022,"At the end of study, the included patients in HBOT group presented significantly better values of oral health index (OHI-S), sulcus bleeding index (SBI), dental mobility (DM), and periodontal pocket depth (PD) than the patients of the control group.  ","['All patients included in the trial benefited from the conventional therapy of full-mouth scaling and root planing (SRP) within 24 h', 'Mild to Moderate Periodontal Affections', 'participant patients in this study (71) required and benefited from specific periodontal disease treatments']",['hyperbaric oxygen therapy (HBOT'],"['oral health index (OHI-S), sulcus bleeding index (SBI), dental mobility (DM), and periodontal pocket depth (PD', 'HBOT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",71.0,0.0522009,"At the end of study, the included patients in HBOT group presented significantly better values of oral health index (OHI-S), sulcus bleeding index (SBI), dental mobility (DM), and periodontal pocket depth (PD) than the patients of the control group.  ","[{'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Burcea', 'Affiliation': 'Faculty of Dental Medicine, Titu Maiorescu University of Bucharest, 031593 Bucharest, Romania.'}, {'ForeName': 'Laurenta Lelia', 'Initials': 'LL', 'LastName': 'Mihai', 'Affiliation': 'Faculty of Dental Medicine, Titu Maiorescu University of Bucharest, 031593 Bucharest, Romania.'}, {'ForeName': 'Anamaria', 'Initials': 'A', 'LastName': 'Bechir', 'Affiliation': 'Faculty of Dental Medicine, Titu Maiorescu University of Bucharest, 031593 Bucharest, Romania.'}, {'ForeName': 'Mircea', 'Initials': 'M', 'LastName': 'Suciu', 'Affiliation': 'Faculty of Dental Medicine, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures, 540142 Targu Mures, Romania.'}, {'ForeName': 'Edwin Sever', 'Initials': 'ES', 'LastName': 'Bechir', 'Affiliation': 'Faculty of Dental Medicine, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures, 540142 Targu Mures, Romania.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina58020234']
2433,35208555,Joint Dysfunctionality Alleviation along with Systemic Inflammation Reduction Following Arthrocen Treatment in Patients with Knee Osteoarthritis: A Randomized Double-Blind Placebo-Controlled Clinical Trial.,"Background and objectives : Many mediators and cytokines are involved in the pathogenesis of osteoarthritis (OA). Some of these cytokines are spontaneously expressed by cultured fibroblast-like synoviocytes. Therefore, using serum samples, the efficacy and the effects of avocado/soy unsaponifiables, ASU, (Arthrocen) on cytokine changes were assessed in patients with knee OA (KOA).  Materials and Methods:  Experimental procedure: A randomized, double-blind, placebo-controlled clinical trial was conducted on patients with a diagnosis of mild to moderate OA who received either Arthrocen 300 mg/day ( n  = 61) or placebo ( n  = 58) for 3 months. Data collection was performed using questionnaires including the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), 20-item short form survey (SF-20), Lequesne index of severity for osteoarthritis of the knee (LISOK), and three visual analog scales (VASs) as pain quality indices. The serum levels of interleukins 2 (IL-2), IL-4, IL-10, IL-17α, and TNF-α were measured using an ELISA reader.  Results:  Both quality of life indices, pain sensation and scored by specialists (as VASs), respectively, including WOMAC and SF-20, as well as joint dysfunctionality symptoms assessed by physicians were significantly improved ( p  < 0.05) in OA patients receiving Arthrocen. The serum levels of anti-inflammatory interleukins 4 and 10 were also augmented, while levels of inflammatory IL-17 and TNF-ɑ cytokines were decreased significantly ( p  < 0.05) compared with the control groups during the 3- and 6-month treatment.  Conclusions:  Arthrocen consumption may increase the quality of life in OA patients through amelioration of inflammation and improvement of functional activities without any adverse effects in the long term.",2022,"The serum levels of anti-inflammatory interleukins 4 and 10 were also augmented, while levels of inflammatory IL-17 and TNF-ɑ cytokines were decreased significantly ( p  < 0.05) compared with the control groups during the 3- and 6-month treatment.  ","['patients with knee OA (KOA', 'Patients with Knee Osteoarthritis', 'patients with a diagnosis of mild to moderate OA who received either Arthrocen 300 mg/day ( n  = 61) or', 'OA patients', 'Experimental procedure']","['Placebo', 'placebo']","['Western Ontario and McMaster Universities osteoarthritis index (WOMAC), 20-item short form survey (SF-20), Lequesne index of severity for osteoarthritis of the knee (LISOK), and three visual analog scales (VASs) as pain quality indices', 'WOMAC and SF-20, as well as joint dysfunctionality symptoms assessed by physicians', 'cytokine changes', 'serum levels of interleukins 2 (IL-2), IL-4, IL-10, IL-17α, and TNF-α', 'levels of inflammatory IL-17 and TNF-ɑ cytokines', 'quality of life', 'quality of life indices, pain sensation and scored by specialists (as VASs', 'serum levels of anti-inflammatory interleukins']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0451257', 'cui_str': 'Lequesne index'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}]",,0.334552,"The serum levels of anti-inflammatory interleukins 4 and 10 were also augmented, while levels of inflammatory IL-17 and TNF-ɑ cytokines were decreased significantly ( p  < 0.05) compared with the control groups during the 3- and 6-month treatment.  ","[{'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Goudarzi', 'Affiliation': 'Division of Research and Development, Pharmin USA, LLC, San Jose, CA 95128, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': 'School of Medicine, University of California, San Francisco, CA 94143, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Ryan', 'Affiliation': 'Independent Scholar, 24298 El Pilar, Laguna Niguel, CA 92677, USA.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina58020228']
2434,35208517,Root Canal Cleaning after Different Irrigation Techniques: An Ex Vivo Analysis.,"Background and Objectives : The endodontic space is a complex area on both micro and macro levels; therefore, traditional irrigation techniques may not guarantee a complete cleaning of such a complicated tridimensional system. The presented ex vivo study aimed to evaluate root canal cleanliness, obtained through an equal volume of traditionally applied sodium hypochlorite (NaOCl), compared to ultrasonically activated NaOCl and ultrasonically activated NaOCl that had undergone intracanal heating NaOCl.  Materials and Methods : A total of 60 freshly extracted human mandibular premolars underwent root sample length standardization (18 mm), root canal preparation and, based on the irrigation method employed, were randomly and equally assigned to three study groups, composed of root samples treated with ultrasonically activated NaOCl, ultrasonically activated NaOCl that had undergone intracanal heating and traditionally applied NaOCl. The root specimens were subsequently fixated with 4% buffered formalin solution and decalcified in Morse liquid. A total often 6-micron-thick serial cross-sections were obtained, dyed using hematoxylin and eosin and examined through an optical microscope at 40×, 100×, and 200×.  Results : Ultrasonically activated NaOCl that had undergone intracanal heating showed a significantly smaller amount of debris compared to ultrasonically activated and traditionally applied NaOCl groups ( p  value < 0.05).  Conclusions : Root canal cleanliness saw significant enhancements by ultrasonically activated NaOCl that had undergone intracanal heating.",2022,Ultrasonically activated NaOCl that had undergone intracanal heating showed a significantly smaller amount of debris compared to ultrasonically activated and traditionally applied NaOCl groups ( p  value < 0.05).  ,"['60 freshly extracted human mandibular premolars underwent root sample length standardization (18 mm), root canal preparation and, based on the irrigation method employed']","['subsequently fixated with 4% buffered formalin solution and decalcified', 'Root Canal Cleaning after Different Irrigation Techniques', 'Materials and Methods ', 'ultrasonically activated NaOCl, ultrasonically activated NaOCl that had undergone intracanal heating and traditionally applied NaOCl', 'sodium hypochlorite (NaOCl']",['smaller amount of debris'],"[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038136', 'cui_str': 'Standardization'}, {'cui': 'C0282543', 'cui_str': 'Root canal preparation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C2959650', 'cui_str': 'Irrigation technique'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}]","[{'cui': 'C3869892', 'cui_str': 'Small amount'}, {'cui': 'C0440266', 'cui_str': 'Debris'}]",60.0,0.0306048,Ultrasonically activated NaOCl that had undergone intracanal heating showed a significantly smaller amount of debris compared to ultrasonically activated and traditionally applied NaOCl groups ( p  value < 0.05).  ,"[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Di Spirito', 'Affiliation': 'Department of Medicine, Surgery and Dentistry, Schola Medica Salernitana, University of Salerno, Via S. Allende, 84081 Baronissi, SA, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Pisano', 'Affiliation': 'Department of Medicine, Surgery and Dentistry, Schola Medica Salernitana, University of Salerno, Via S. Allende, 84081 Baronissi, SA, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Caggiano', 'Affiliation': 'Department of Medicine, Surgery and Dentistry, Schola Medica Salernitana, University of Salerno, Via S. Allende, 84081 Baronissi, SA, Italy.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Bhasin', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, Sudha Rustagi College of Dental Sciences and Research Faridabad, Faridabad 121002, India.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Lo Giudice', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Messina, 98122 Messina, ME, Italy.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Abdellatif', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, University of Alexandria, Alexandria 21545, Egypt.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina58020193']
2435,35209986,Evaluation of the clinical effect of an artificial intelligence-assisted diagnosis and treatment system for neonatal seizures in the real world: a multicenter clinical study protocol.,"Neonatal seizures are the most common clinical manifestations of critically ill neonates and often suggest serious diseases and complicated etiologies. The precise diagnosis of this disease can optimize the use of anti-seizure medication, reduce hospital costs, and improve the long-term neurodevelopmental outcomes. Currently, a few artificial intelligence-assisted diagnosis and treatment systems have been developed for neonatal seizures, but there is still a lack of high-level evidence for the diagnosis and treatment value in the real world. Based on an artificial intelligence-assisted diagnosis and treatment systems that has been developed for neonatal seizures, this study plans to recruit 370 neonates at a high risk of seizures from 6 neonatal intensive care units (NICUs) in China, in order to evaluate the effect of the system on the diagnosis, treatment, and prognosis of neonatal seizures in neonates with different gestational ages in the NICU. In this study, a diagnostic study protocol is used to evaluate the diagnostic value of the system, and a randomized parallel-controlled trial is designed to evaluate the effect of the system on the treatment and prognosis of neonates at a high risk of seizures. This multicenter prospective study will provide high-level evidence for the clinical application of artificial intelligence-assisted diagnosis and treatment systems for neonatal seizures in the real world.",2022,This multicenter prospective study will provide high-level evidence for the clinical application of artificial intelligence-assisted diagnosis and treatment systems for neonatal seizures in the real world.,"['370 neonates at a high risk of seizures from 6 neonatal intensive care units (NICUs) in China', 'neonates with different gestational ages in the NICU', 'neonates at a high risk of seizures']","['artificial intelligence-assisted diagnosis and treatment system', 'artificial intelligence-assisted diagnosis']",[],"[{'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}]","[{'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",[],,0.113007,This multicenter prospective study will provide high-level evidence for the clinical application of artificial intelligence-assisted diagnosis and treatment systems for neonatal seizures in the real world.,"[{'ForeName': 'Tian-Tian', 'Initials': 'TT', 'LastName': 'Xiao', 'Affiliation': ""Department of Neonatology, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201101, China.""}, {'ForeName': 'Ya-Lan', 'Initials': 'YL', 'LastName': 'Dou', 'Affiliation': ''}, {'ForeName': 'De-Yi', 'Initials': 'DY', 'LastName': 'Zhuang', 'Affiliation': ''}, {'ForeName': 'Xu-Hong', 'Initials': 'XH', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Wen-Qing', 'Initials': 'WQ', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Xiao-Fen', 'Initials': 'XF', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201101, China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Yan', 'Affiliation': ""Department of Neonatology, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201101, China.""}, {'ForeName': 'Wei-Li', 'Initials': 'WL', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Guo-Qiang', 'Initials': 'GQ', 'LastName': 'Cheng', 'Affiliation': ""Department of Neonatology, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201101, China.""}, {'ForeName': 'Wen-Hao', 'Initials': 'WH', 'LastName': 'Zhou', 'Affiliation': ""Department of Neonatology, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai 201101, China.""}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,['10.7499/j.issn.1008-8830.2112124']
2436,35209984,Efficacy of intermittent iron supplementation in children with mild iron-deficiency anemia.,"OBJECTIVES


To study the efficacy of intermittent iron supplementation in children with mild iron-deficiency anemia.
METHODS


A total of 147 children with mild iron-deficiency anemia were enrolled in this prospective study. They were divided into an intermittent iron supplementation group ( n =83) and a conventional iron supplementation group ( n =64). The levels of hemoglobin were measured before treatment and after 1 and 3 months of treatment. The treat response rate and the incidence rate of adverse drug reactions were compared between the two groups.
RESULTS


Both groups had a significant increase in the level of hemoglobin after iron supplementation ( P <0.05). After 1 month of treatment, the conventional iron supplementation group had a significantly higher treatment response rate than the intermittent iron supplementation group (61% vs 42%,  P <0.05). After 3 months of treatment, there was no significant difference in the treatment response between the two groups (86% vs 78%,  P >0.05). The incidence rate of adverse drug reactions in the conventional iron supplementation group was significantly higher than that in the intermittent iron supplementation group (25% vs 8%,  P <0.05).
CONCLUSIONS


For children with mild iron-deficiency anemia, although intermittent iron supplementation is inferior to conventional iron supplementation in the short-term efficacy, there is no significant difference in the long-term efficacy between the two methods, and compared with conventional iron supplementation, intermittent iron supplementation can reduce the incidence of adverse drug reactions, alleviate family financial burdens, and improve treatment compliance of children, thus holding promise for clinical application.",2022,"The incidence rate of adverse drug reactions in the conventional iron supplementation group was significantly higher than that in the intermittent iron supplementation group (25% vs 8%,  P <0.05).
","['147 children with mild iron-deficiency anemia', 'children with mild iron-deficiency anemia']","['conventional iron supplementation', 'intermittent iron supplementation']","['treatment response', 'treatment response rate', 'level of hemoglobin after iron supplementation', 'incidence rate of adverse drug reactions', 'levels of hemoglobin']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}]",147.0,0.0910305,"The incidence rate of adverse drug reactions in the conventional iron supplementation group was significantly higher than that in the intermittent iron supplementation group (25% vs 8%,  P <0.05).
","[{'ForeName': 'Jian-Yun', 'Initials': 'JY', 'LastName': 'Li', 'Affiliation': 'Department of Child Health Care, Luohu Maternal and Child Health Care Hospital, Shenzhen, Guangdong 518019, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Child Health Care, Luohu Maternal and Child Health Care Hospital, Shenzhen, Guangdong 518019, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Child Health Care, Luohu Maternal and Child Health Care Hospital, Shenzhen, Guangdong 518019, China.'}, {'ForeName': 'Xiao-Lan', 'Initials': 'XL', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Ji-Wen', 'Initials': 'JW', 'LastName': 'Liu', 'Affiliation': 'Department of Child Health Care, Luohu Maternal and Child Health Care Hospital, Shenzhen, Guangdong 518019, China.'}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,['10.7499/j.issn.1008-8830.2110036']
2437,35209951,"The ""Blood pressure and oxygenation targets in post resuscitation care, a randomized clinical trial"": design and statistical analysis plan.","BACKGROUND


Comatose patients admitted after resuscitation from cardiac arrest have a significant risk of poor outcome due to hypoxic brain injury. While numerous studies have investigated and challenged the target temperature as the efficacious part of the guideline endorsed Targeted Temperature Management (TTM) protocols, our knowledge and how the remaining parts of the TTM are optimized remain sparse. The present randomized trial investigated two aspects of the TTM protocol: target blood pressure during the ICU stay and oxygenation during mechanical ventilation. Furthermore, the efficacy of device-based post-TTM fever management is addressed.
METHODS


Investigator-initiated, dual-center, randomized clinical trial in comatose OHCA patients admitted to an intensive cardiac care unit. Patients are eligible for inclusion if unconscious, older than 18 years of age, and have return of spontaneous circulation for more than 20 min.
INTERVENTION


allocation 1:1:1:1 into a group defined by (a) blood pressure targets in double-blind intervention targeting a mean arterial blood pressure of 63 or 77 mmHg and (b) restrictive (9-10 kPa) or liberal (13-14 kPa) of arterial oxygen concentration during mechanical ventilation. As a subordinate intervention, device-based active fever management is discontinued after 36 h or 72. Patients will otherwise receive protocolized standard of care according to international guidelines, including targeted temperature management at 36 °C for 24 h, sedation with fentanyl and propofol, and multimodal neuro-prognostication. Primary endpoint: Discharge from hospital in poor neurological status (Cerebral Performance category 3 or 4) or death, whichever comes first.
SECONDARY OUTCOMES


Time to initiation of renal replacement therapy or death, neuron-specific enolase (NSE) level at 48 h, MOCA score at day 90, Modified Ranking Scale (mRS) and CPC at 3 months, NT-pro-BNP at 90 days, eGFR and LVEF at 90 days, daily cumulated vasopressor requirement during ICU stay, and need for a combination of vasopressors and inotropic agents or mechanical circulatory support.
DISCUSSION


We hypothesize that low or high target blood pressure and restrictive and liberal oxygen administration will have an impact on mortality by reducing the risk and degree of hypoxic brain injury. This will be assessment neurological outcome and biochemical and neuropsychological testing after 90 days.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03141099. Registered on May 2017 (retrospectively registered).",2022,"(NSE) level at 48 h, MOCA score at day 90, Modified Ranking Scale (mRS) and CPC at 3 months, NT-pro-BNP at 90 days, eGFR and LVEF at 90 days, daily cumulated vasopressor requirement during ICU stay, and need for a combination of vasopressors and inotropic agents or mechanical circulatory support.
","['Comatose patients admitted after resuscitation from cardiac arrest', 'Patients are eligible for inclusion if unconscious, older than 18\u2009years of age, and have return of spontaneous circulation for more than 20\u2009min', 'comatose OHCA patients admitted to an intensive cardiac care unit']","['blood pressure targets in double-blind intervention targeting a mean arterial blood pressure of 63 or 77\u2009mmHg and (b) restrictive (9-10\u2009kPa) or liberal (13-14\u2009kPa) of arterial oxygen concentration during mechanical ventilation', 'fentanyl and propofol, and multimodal neuro-prognostication']","['NSE) level at 48\u2009h, MOCA score at day 90, Modified Ranking Scale (mRS) and CPC', 'Discharge from hospital in poor neurological status (Cerebral Performance category 3 or 4) or death', 'Time to initiation of renal replacement therapy or death, neuron-specific enolase']","[{'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0041654', 'cui_str': 'Unconscious (Psychology)'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0263428', 'cui_str': 'Ulerythema ophryogenes'}, {'cui': 'C0428181', 'cui_str': 'Arterial oxygen concentration measurement'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}]","[{'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0699794', 'cui_str': 'Rank'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0746866', 'cui_str': 'Neurological status'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]",,0.191078,"(NSE) level at 48 h, MOCA score at day 90, Modified Ranking Scale (mRS) and CPC at 3 months, NT-pro-BNP at 90 days, eGFR and LVEF at 90 days, daily cumulated vasopressor requirement during ICU stay, and need for a combination of vasopressors and inotropic agents or mechanical circulatory support.
","[{'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kjaergaard', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. jesper.kjaergaard.05@regionh.dk.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cardiothoracic Intensive Care, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}]",Trials,['10.1186/s13063-022-06101-6']
2438,35209942,"The effect of probiotic cheese consumption on inflammatory and anti-inflammatory markers, disease severity, and symptoms in patients with rheumatoid arthritis: study protocol for a randomized, double-blind, placebo-controlled trial.","BACKGROUND


In recent decades, several studies have shown changes in the intestinal microflora among patients with rheumatoid arthritis (RA). Therapeutic measures using probiotics have shown favorable effects on the recovery of these patients. However, most studies have used probiotic supplements. In this study, we aimed to investigate the effect of probiotic cheese consumption on inflammatory and anti-inflammatory factors, disease severity, and symptoms in these patients.
METHODS


This study is a randomized, double-blind clinical trial, in which forty patients with mild to moderate severity of RA will be randomly allocated to receive either 30 g/day probiotic cheese (n = 20) or only low-salt and low-fat cheese without any added probiotic (n = 20) for 12 weeks. Assessment of anthropometric measures and biochemical indicators, including serum concentrations of high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-10 (IL-10), will be done at the study baseline and end of the trial. In addition, disease severity and disability will be assessed by DAS-28 and the HAQ-DI questionnaire, respectively.
DISCUSSION


Diet is the leading environmental factor affecting the gut microbiota. A prebiotic-rich diet and probiotics might be beneficial in this regard. To the best of our knowledge, the effect of probiotic supplements on inflammation in these patients has widely been assessed; however, there is only one study that examined the effect of probiotic-containing food in these patients. Further studies are needed to investigate the effect of probiotic-containing foods on inflammatory markers and symptoms in patients with RA.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials IRCT20201120049449N1 . Registered on 14 February 2021.",2022,"Assessment of anthropometric measures and biochemical indicators, including serum concentrations of high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-10 (IL-10), will be done at the study baseline and end of the trial.","['forty patients with mild to moderate severity of RA', 'patients with rheumatoid arthritis', 'patients with RA', 'patients with rheumatoid arthritis (RA']","['probiotic supplements', 'placebo', '30 g/day probiotic cheese (n = 20) or only low-salt and low-fat cheese without any added probiotic', 'probiotic cheese consumption', 'probiotic-containing foods']","['disease severity and disability', 'serum concentrations of high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-10 (IL-10', 'inflammatory and anti-inflammatory markers, disease severity, and symptoms', 'inflammatory and anti-inflammatory factors, disease severity, and symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",40.0,0.426444,"Assessment of anthropometric measures and biochemical indicators, including serum concentrations of high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-10 (IL-10), will be done at the study baseline and end of the trial.","[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Asoudeh', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kurosh', 'Initials': 'K', 'LastName': 'Djafarian', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maassoumeh', 'Initials': 'M', 'LastName': 'Akhalghi', 'Affiliation': 'Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran. akhlaghimd@yahoo.com.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Mahmoudi', 'Affiliation': 'Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad Reza', 'Initials': 'AR', 'LastName': 'Jamshidi', 'Affiliation': 'Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Farhadi', 'Affiliation': 'Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': 'Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, P.O. Box 14155-6117, Tehran, Iran. a-esmaillzadeh@tums.ac.ir.'}]",Trials,['10.1186/s13063-022-06113-2']
2439,35209939,"Effect of omega-3 fatty acids on TH1/TH2 polarization in individuals with high exposure to particulate matter ≤ 2.5 μm (PM2.5): a randomized, double-blind, placebo-controlled clinical study.","BACKGROUND


Long-term exposure to high concentrations of PM2.5 may cause immune system dysfunction and damage to the respiratory and cardiovascular systems. PM2.5 may cause CD4 + T helper cells to polarize toward TH1 or TH2 cell types, which may be associated with the onset and progression of many human diseases. Recent studies have shown that omega-3 fatty acids can regulate human immune function and reduce physiological damage caused by air pollution; however, only limited research has examined the therapeutic effects of omega-3 fatty acids on subjects with high exposure to PM2.5 in mass transit systems such as subways.
METHODS


This study was designed as a prospective, randomized, double-blinded (to participants and researchers), placebo-controlled clinical trial. The research plan is to randomly select 120 eligible adults based on the difference in PM2.5 exposure in the Chengdu subway station. They should be aged 20-65 years old and work in the subway station more than or equal to 3 times a week, each time greater than or equal to 8 h, and had worked continuously in the subway station for more than 2 years. All participants will receive omega-3 fatty acids or placebo for 8 weeks. The primary outcomes will be changes in the TH1/TH2 cell polarization index and changes in serum cytokine concentrations. Secondary outcomes will be changes in early indicators of atherosclerosis, pulmonary function, COOP/WONCA charts, and scores on the Short-Form 36 Health Survey for quality of life. Results will be analyzed to evaluate differences in clinical efficacy between the two groups. A 6-month follow-up period will be used to assess the long-term value of omega-3 fatty acids for respiratory and cardiovascular disease endpoints.
DISCUSSION


We will explore the characteristics of the TH1/TH2 cell polarization index in a population with high exposure to PM2.5. Omega-3 fatty acids and placebo will be compared in many ways to test the effect on people exposed to PM2.5 subway stations. This study is expected to provide reliable evidence to support the promotion of omega-3 fatty acids in clinical practice to protect individuals who are highly exposed to PM2.5.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR2000038065 . Registered on September 9, 2020.",2022,"PM2.5 may cause CD4 + T helper cells to polarize toward TH1 or TH2 cell types, which may be associated with the onset and progression of many human diseases.","['120 eligible adults based on the difference in PM2.5 exposure in the Chengdu subway station', 'individuals with high exposure to particulate matter ≤ 2.5\u2009μm (PM2.5', 'population with high exposure to PM2.5', 'aged 20-65\u2009years old and work in the subway station more than or equal to 3 times a week, each time greater than or equal to 8\u2009h, and had worked continuously in the subway station for more than 2\u2009years']","['Omega-3 fatty acids and placebo', 'omega-3 fatty acids or placebo', 'omega-3 fatty acids', 'placebo']","['changes in early indicators of atherosclerosis, pulmonary function, COOP/WONCA charts, and scores on the Short-Form 36 Health Survey for quality of life', 'TH1/TH2 cell polarization index and changes in serum cytokine concentrations', 'TH1/TH2 polarization', 'clinical efficacy']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0562722', 'cui_str': 'Underground railway station'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",120.0,0.616818,"PM2.5 may cause CD4 + T helper cells to polarize toward TH1 or TH2 cell types, which may be associated with the onset and progression of many human diseases.","[{'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Shuiqin', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Yongcan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Demei', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Pei', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Yilan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Zhenxing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China. wangzhenxing@vip.tom.com.""}]",Trials,['10.1186/s13063-022-06091-5']
2440,35216853,Encouraging COVID-19 vaccination via an evolutionary theoretical approach: A randomized controlled study in Japan.,"OBJECTIVE


We aimed to examine the effect of a message that target the fundamental human motive of kin care on COVID-19 vaccination recommendations among participants with young children, based on an evolutionary theoretical approach.
METHODS


Participants with young children (n = 969) were randomly assigned either to a group that received an intervention message that targeted the fundamental motive of kin care, or that targeted the fundamental motive of disease avoidance, or a control message. Intention to receive COVID-19 vaccination was assessed both before and after reading the messages. A one-way ANOVA with Tukey's or Games-Howell test was conducted.
RESULTS


An intervention message targeting the fundamental motive of kin care and disease avoidance significantly increased intention of vaccination versus a control message (p < 0.001, respectively).
CONCLUSION


The evolutionary theoretical approach that focuses on fundamental human motives has the potential to extend the communication strategy for COVID-19 vaccination recommendations.
PRACTICE IMPLICATIONS


Health professionals should deliver messages that target the fundamental motive of kin care as well as messages about the susceptibility and severity of COVID-19 and vaccine efficacy (e.g., ""Get vaccinated against COVID-19 for your child's sake, because if you are infected, you will be unable to care for your child."").",2022,"An intervention message targeting the fundamental motive of kin care and disease avoidance significantly increased intention of vaccination versus a control message (p < 0.001, respectively).
","['Participants with young children (n\xa0=\xa0969', 'participants with young children, based on an evolutionary theoretical approach', 'Japan']","['intervention message that targeted the fundamental motive of kin care, or that targeted the fundamental motive of disease avoidance, or a control message']",[],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0682416', 'cui_str': 'Ruanda language'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],969.0,0.13512,"An intervention message targeting the fundamental motive of kin care and disease avoidance significantly increased intention of vaccination versus a control message (p < 0.001, respectively).
","[{'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Okuhara', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan. Electronic address: okuhara-ctr@umin.ac.jp.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Eiko', 'Initials': 'E', 'LastName': 'Goto', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Tsunezumi', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Kagawa', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kiuchi', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan.'}]",Patient education and counseling,['10.1016/j.pec.2022.02.013']
2441,35216783,Feasibility and efficacy of home-based neurofunctional exercise vs. resistance exercise programs for ambulatory disability of multiple sclerosis patients with cognitive impairment.,"BACKGROUND


Ambulatory disability and cognitive impairment are common and co-occuring manifestations of multiple sclerosis (MS). Neurofunctional training is a specific intervention performed in realistic environments that may have beneficial effects on ambulatory disability in persons with MS who have cognitive impairment. This pilot sudy investigated the feasibility and efficacy of an eight-week home-based neurofunctional training (HBNFT) program vs. home-based resistance training (HBRT) on ambulatory performance in MS patients with cognitive impairment.
METHODS


Thirty males/females with MS (age 18-50 years, Expanded Disability Status Scale (EDSS) score ≤ 6, and processing speed score ≤ 41.5 as a marker of cognitive impairment) were randomly assigned into HBNFT and HBRT groups. After one week (three sessions) of center-based, supervised training for learning the programs and maximizing safety, the participants completed eight weeks (three sessions per week) of the home-based training programs. The programs were supported through videos, brochures and Digital Video Discs (DVDs) provided during clinic visits (weeks 1 and 5). Ambulatory performance (tandem stance test; tandem walk test; timed up-and-go (TUG); six-minute walk test (6MWT), 10- meter walking test (10MWT); timed 25 foot walk test (T25FWT); five times sit to stand test (5TSTS); six spot step test (SSST); and hand grip) was measured before and after the exercise programs. Feasibility and acceptability of exercise programs was assessed after the eight-week period.
RESULTS


HBNFT significantly improved tandem walk test (P = 0.018), SSST (P = 0.026), and 6MWT (P = 0.037) compared with HBRT. No significant changes or differences were observed in other outcomes (P ≥ 0.05). HBNFT was well tolerated and resulted in no adverse events, whereas there were reports of pain, muscle cramps, and extreme fatigue among HBRT participant.
CONCLUSION


The current pilot study provided initial support for HBNFT as a safe and feasible approach for improving some aspects of ambulation in persons with MS who have cognitive impairment. Such a pilot study provides initial proof-of-concept data for the design and implementation of an appropriately-powered randomized controlled trial (RCT) of neuro-functional training vs. traditional resistance exercise in a larger sample of persons with MS who present with co-occurring impairments in mobility and cognition.",2022,"RESULTS


HBNFT significantly improved tandem walk test (P = 0.018), SSST (P = 0.026), and 6MWT (P = 0.037) compared with HBRT.","['persons with MS who present with co-occurring impairments in mobility and cognition', 'persons with MS who have cognitive impairment', 'Thirty males/females with MS (age 18-50 years, Expanded Disability Status Scale (EDSS) score ≤ 6, and processing speed score ≤ 41.5 as a marker of cognitive impairment', 'MS patients with cognitive impairment', 'multiple sclerosis patients with cognitive impairment']","['eight-week home-based neurofunctional training (HBNFT) program vs. home-based resistance training (HBRT', 'Neurofunctional training', 'home-based neurofunctional exercise vs. resistance exercise programs', 'HBNFT', 'neuro-functional training vs. traditional resistance exercise', 'HBNFT and HBRT']","['ambulatory performance', 'ambulatory disability', '10-\xa0meter walking test (10MWT); timed 25 foot walk test (T25FWT); five times sit to stand test (5TSTS); six spot step test (SSST); and hand grip', 'feasibility and efficacy', 'pain, muscle cramps, and extreme fatigue', 'Ambulatory performance (tandem stance test; tandem walk test; timed up-and-go (TUG); six-minute walk test (6MWT', 'SSST', 'tandem walk test']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.0146268,"RESULTS


HBNFT significantly improved tandem walk test (P = 0.018), SSST (P = 0.026), and 6MWT (P = 0.037) compared with HBRT.","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mardaniyan Ghahfarrokhi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Banitalebi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran. Electronic address: banitalebi@sku.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.103400']
2442,35217236,Sitagliptin/metformin improves the fertilization rate and embryo quality in polycystic ovary syndrome patients through increasing the expression of GDF9 and BMP15: A new alternative to metformin (a randomized trial).,"The aim of this study was to investigate the effects of sitagliptin/metformin (sitaformin), metformin and sitagliptin in PCOS patients. PCOS is a hormonal disorder and therefore the use of treatments that modulate hormone levels Like AMH, testosterone, insulin, leptin and especially FAI and HOMA-IR can reclaim the symptoms of PCOS. PCOS also increases oxidative stress and lipid peroxidation. Therefore, in clinical and research trials, the level of these factors is usually examined to reduce patients' symptoms. Participants were randomly assigned to receive metformin, sitagliptin, sitaformin or placebo Treatment was carried out 2 months before the start of the ovulation cycle and continued until the day of ovum pick up. The serum levels of HOMA-IR and FAI decreased significantly in the treated groups compared to the placebo. The serum and the FF levels of leptin also decreased significantly in the sitaformin group when compared to the metformin and sitagliptin groups. Moreover, the serum and FF levels of AMH and MDA had a significant decrease in the sitaformin and sitagliptin group compared to the placebo. The mRNA expression and protein levels of GDF9 and BMP15 in the cumulus cells increased significantly in the sitaformin compared to metformin and sitagliptin groups. The expression level of GDF9 and BMP15 mRNA were positively correlated with the fertilization rate and grade I embryos. Sitaformin improves levels of GDF9 and BMP15 in PCOS compared to metformin and sitagliptin, which can increase the rate of fertilization and grade I embryos.",2022,"Sitaformin improves levels of GDF9 and BMP15 in PCOS compared to metformin and sitagliptin, which can increase the rate of fertilization and grade I embryos.","['polycystic ovary syndrome patients', 'PCOS patients']","['metformin', 'sitagliptin/metformin (sitaformin), metformin and sitagliptin', 'placebo', 'metformin, sitagliptin, sitaformin or placebo', 'Sitagliptin/metformin', 'PCOS']","['serum and the FF levels of leptin', 'oxidative stress and lipid peroxidation', 'levels of GDF9 and BMP15 in PCOS', 'rate of fertilization and grade I embryos', 'serum levels of HOMA-IR and FAI', 'mRNA expression and protein levels of GDF9 and BMP15 in the cumulus cells', 'expression level of GDF9 and BMP15 mRNA', 'fertilization rate and embryo quality', 'serum and FF levels of AMH and MDA']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1952576', 'cui_str': 'metformin and sitagliptin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C1686883', 'cui_str': 'GDF9 protein, human'}, {'cui': 'C0905649', 'cui_str': 'GDF-9 Related Factor'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C1956101', 'cui_str': 'Granulosa Cells, Cumulus'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}]",,0.0809303,"Sitaformin improves levels of GDF9 and BMP15 in PCOS compared to metformin and sitagliptin, which can increase the rate of fertilization and grade I embryos.","[{'ForeName': 'Delbar', 'Initials': 'D', 'LastName': 'Daneshjou', 'Affiliation': 'Biology Department, Faculty of Science, Arak University,\xa0PO Box 3815688138, Arak, Iran.'}, {'ForeName': 'Malek Soleimani', 'Initials': 'MS', 'LastName': 'Mehranjani', 'Affiliation': 'Biology Department, Faculty of Science, Arak University,\xa0PO Box 3815688138, Arak, Iran. Electronic address: m-soleimani@araku.ac.ir.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Zadehmodarres', 'Affiliation': ""Men's Health and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, PO Box 1989930002, Tehran, Iran.""}, {'ForeName': 'Seyed Mohammad Ali', 'Initials': 'SMA', 'LastName': 'Shariatzadeh', 'Affiliation': 'Biology Department, Faculty of Science, Arak University,\xa0PO Box 3815688138, Arak, Iran.'}, {'ForeName': 'Zahra Shams', 'Initials': 'ZS', 'LastName': 'Mofarahe', 'Affiliation': 'Department of Biology and Anatomical sciences, school of medicine, Shahid Beheshti University of Medical Sciences, PO Box 193954719, Tehran, Iran.'}]",Journal of reproductive immunology,['10.1016/j.jri.2022.103499']
2443,35217211,Gamification of cognitive bias modification for interpretations in anxiety increases training engagement and enjoyment.,"BACKGROUND AND OBJECTIVES


Interpretation bias plays a crucial role in anxiety. To test the causal role and potential clinical benefits, training procedures were developed to experimentally change interpretation bias. However, these procedures are monotonous and plain, which could negatively affect motivation and adherence. The aim of this study was to make the interpretation training more engaging and enjoyable, without compromising its effectiveness, through gamification.
METHODS


The training was gamified by including extrinsically and intrinsically motivating elements such as points, scores, time-pressure, fun and adaptive elements (training at an individually challenging level). A 2 (Type: Gamified vs. Standard) x 2 (Training Valence: Positive vs. Placebo) between-subjects design was used with random allocation of 79 above-average anxious individuals. Post-training, we assessed the liking and recommendation of the training task, interpretation bias (Recognition task and the Scrambled Sentence Task) and anxiety.
RESULTS


Participants experienced the gamified training tasks as more engaging and enjoyable than the standard tasks, although it was not recommend more to fellow-students. Both positive training conditions (gamified and standard) were successful in eliciting a positive interpretation bias when assessed with the Recognition task, while only the standard positive training impacted on interpretations when assessed with the Scrambled Sentence Task. No differential effects were observed on anxiety.
LIMITATIONS


The study involved only a single-session training and participants were selected for high trait (and not social) anxiety.
CONCLUSIONS


The gamified training was evaluated more positively by the participants, while maintaining the effectiveness of eliciting positive interpretations when assessed with the Recognition task. This suggests that gamification might be a promising new approach.",2022,"The gamified training was evaluated more positively by the participants, while maintaining the effectiveness of eliciting positive interpretations when assessed with the Recognition task.",['subjects design was used with random allocation of 79 above-average anxious individuals'],['A 2 (Type: Gamified vs. Standard) x 2 (Training Valence: Positive vs. Placebo'],"['anxiety', 'liking and recommendation of the training task, interpretation bias (Recognition task and the Scrambled Sentence Task) and anxiety']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",,0.0203997,"The gamified training was evaluated more positively by the participants, while maintaining the effectiveness of eliciting positive interpretations when assessed with the Recognition task.","[{'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'Salemink', 'Affiliation': 'Department of Psychology, University of Amsterdam, P.O. Box 80140, 3508, TC, Utrecht, the Netherlands; Department of Clinical Psychology, Utrecht University, the Netherlands. Electronic address: E.Salemink@uu.nl.'}, {'ForeName': 'Suzanne R C', 'Initials': 'SRC', 'LastName': 'de Jong', 'Affiliation': 'Department of Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1018, BT, Amsterdam, the Netherlands. Electronic address: s.r.c.dejong@vu.nl.'}, {'ForeName': 'Lies', 'Initials': 'L', 'LastName': 'Notebaert', 'Affiliation': 'School of Psychological Science, University of Western Australia, 35 Stirling Highway, WA 6009, Crawley, Australia. Electronic address: Lies.Notebaert@uwa.edu.au.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'MacLeod', 'Affiliation': 'School of Psychological Science, University of Western Australia, 35 Stirling Highway, WA 6009, Crawley, Australia. Electronic address: Colin.MacLeod@uwa.edu.au.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Van Bockstaele', 'Affiliation': 'School of Psychological Science, University of Western Australia, 35 Stirling Highway, WA 6009, Crawley, Australia; Research Institute of Child Development and Education, University of Amsterdam, Nieuwe Achtergracht 129-B, 1018, WT, Amsterdam, the Netherlands. Electronic address: b.d.vanbockstaele@uva.nl.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2022.101727']
2444,35217351,Therapeutic efficacy of seizure onset zone-targeting high-definition cathodal tDCS in patients with drug-resistant focal epilepsy.,"OBJECTIVE


Epilepsy is a common neurological disease with recurrent seizures. Transcranial direct-current stimulation (tDCS) is a safe, non-invasive method used for neuromodulation. The aim of this study was to explore the efficacy of cathodal high-definition tDCS (HD-tDCS) as a noninvasive method for the treatment of patients with drug-resistant focal epilepsy (DRFE).
METHODS


This study was conducted as a randomized parallel and double-blind clinical trial. Twenty patients with DRFE were randomly selected through the convenience sampling method and then were divided into two groups. Ten patients received 2 mA cathodal HD-tDCS targeting the seizure-onset zone for 30 min for 2 weeks (5 consecutive days in each week and 10 days in total). Ten patients were randomized to the sham group. Seizure frequency and Interictal Epileptiform Discharges (IEDs) frequency were the primary outcome measures of this study. Quality of Life in Epilepsy Inventory (QoLIE-89) and Montreal Cognitive Assessment (MoCA) scores were used as secondary outcome measures.
RESULTS


Seizure frequency decreased significantly among the patients in the treatment group 2 weeks (P-value ≤ 0.05), 1 month (P-value ≤ 0.05), and 2 months (P-value ≤ 0.05) after the stimulation in comparison to the sham group. Patients in the treatment group showed a decrease in the frequency of IED 2 weeks (P-value ≤ 0.05), 1 month (P-value ≤ 0.05), and 2 months (P-value ≤ 0.05) after stimulation. This cathodal stimulation protocol also improved the overall QoLIE-89 score after the stimulation compared to the sham group.
CONCLUSIONS


The present study showed that cathodal HD-tDCS had a positive effect on seizure frequency and IED in patients with DRFE. More evidence is required to define the optimal stimulation parameters of HD-tDCS for the treatment of epilepsy.
SIGNIFICANCE


Cathodal HD-tDCS targeting the seizure-onset zone is a promising treatment modality for patients with drug-resistant focal epilepsy.",2022,"RESULTS


Seizure frequency decreased significantly among the patients in the treatment group 2 weeks (P-value ≤ 0.05), 1 month (P-value ","['patients with DRFE', 'patients with drug-resistant focal epilepsy (DRFE', 'Twenty patients with DRFE', 'patients with drug-resistant focal epilepsy']","['cathodal HD-tDCS', 'Cathodal HD-tDCS', 'seizure onset zone-targeting high-definition cathodal tDCS', 'Transcranial direct-current stimulation (tDCS', 'cathodal high-definition tDCS (HD-tDCS', '2\xa0mA cathodal HD-tDCS']","['frequency of IED', 'seizure frequency and IED', 'Seizure frequency', 'Quality of Life in Epilepsy Inventory (QoLIE-89) and Montreal Cognitive Assessment (MoCA) scores', 'overall QoLIE-89 score', 'Seizure frequency and Interictal Epileptiform Discharges (IEDs) frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",20.0,0.097977,"RESULTS


Seizure frequency decreased significantly among the patients in the treatment group 2 weeks (P-value ≤ 0.05), 1 month (P-value ","[{'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Rezakhani', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Amiri', 'Affiliation': 'Medical Technology Research Center, Institute of Health Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: ma_amiri_bme@yahoo.com.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Weckhuysen', 'Affiliation': 'Applied & Translational Neurogenomics Group, VIB Center for Molecular Neurology, VIB, Antwerp, Belgium; Translational Neurosciences, Faculty of Medicine and Health Science, University of Antwerp, Antwerp, Belgium; Department of Neurology, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Georgios A', 'Initials': 'GA', 'LastName': 'Keliris', 'Affiliation': 'Bio-imaging Lab, University of Antwerp, Antwerp, Belgium.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2022.01.130']
2445,35210504,Effect of single session receptive music therapy on anxiety and vital parameters in hospitalized Covid-19 patients: a randomized controlled trial.,"Hospitalized COVID-19 patients are vulnerable to different degrees of stress disorders as well as depression, anxiety and fear. The aim of this study was to evaluate the feasibility of introducing Music therapy on site with Covid-19 patients and investigating the immediate effects a single session has on anxiety, heart rate (HR), oxygen saturation (O2Sat) and satisfaction compared to standard care. A randomized controlled trial of 40 patients was conducted. Participants were assigned to control group (CG) or the treatment group (MG). MG received an individual single session of music therapy in presence. CG received standard care. MG and CG were subjected to identical measurements (pre-during-post) of the parameters STAI-Y, HR and O2Sat. Participants in MG were asked to fill in an optional open-ended question concerning their experience with music therapy. Significant difference in anxiety levels between scores in MG and CG (34.50 (23.25-40.00) vs 45.00(38, 25-54.00); p = 0.000) was observed. MG compared to CG had statistically significantly higher values of O2Sat (97.50 (96.25-99.00) versus 96.00 (96.00-98.00); p = 0.026). Results show the feasibility of introducing music therapy as a supporting complementary/non-pharmacological intervention on site in Covid-19 patients. A single session of music therapy improves O2Sat and can significantly reduce anxiety.Trial registration: 14/10/2021 No. NCT05077306. https://www.clinicaltrials.cov .",2022,MG compared to CG had statistically significantly higher values of O2Sat (97.50 (96.25-99.00) versus 96.00 (96.00-98.00); p = 0.026).,"['hospitalized Covid-19 patients', '40 patients was conducted', 'Covid-19 patients']","['control group (CG', 'music therapy', 'Music therapy', 'single session receptive music therapy']","['O2Sat', 'anxiety and vital parameters', 'anxiety', 'anxiety levels', 'anxiety, heart rate (HR), oxygen saturation (O2Sat) and satisfaction']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",40.0,0.0485483,MG compared to CG had statistically significantly higher values of O2Sat (97.50 (96.25-99.00) versus 96.00 (96.00-98.00); p = 0.026).,"[{'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Giordano', 'Affiliation': 'Department of Emergency and Organ Transplants, University of Bari Aldo Moro, Piazza G. Cesare 11, 70124, Bari, Italy. filippo.giordano@uniba.it.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Losurdo', 'Affiliation': 'University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Vitaliano Nicola', 'Initials': 'VN', 'LastName': 'Quaranta', 'Affiliation': 'Pneumology Department, ""Di Venere"" Hospital Bari, Bari, Italy.'}, {'ForeName': 'Nicla', 'Initials': 'N', 'LastName': 'Campobasso', 'Affiliation': 'Department of Emergency and Organ Transplants, University of Bari Aldo Moro, Piazza G. Cesare 11, 70124, Bari, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Daleno', 'Affiliation': 'Azienda Universitaria Ospedaliera Consorziale-Policlinico Bari, Bari, Italy.'}, {'ForeName': 'Elisiana', 'Initials': 'E', 'LastName': 'Carpagnano', 'Affiliation': 'Department of Basic Medical Science, Neuroscience, and Sense Organs, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Loreto', 'Initials': 'L', 'LastName': 'Gesualdo', 'Affiliation': 'Department of Emergency and Organ Transplants, University of Bari Aldo Moro, Piazza G. Cesare 11, 70124, Bari, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Moschetta', 'Affiliation': 'Department of Interdisciplinary Medicine, University of Bari Aldo Moro, Piazza G. Cesare 11, 70124, Bari, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Brienza', 'Affiliation': 'Department of Interdisciplinary Medicine, University of Bari Aldo Moro, Piazza G. Cesare 11, 70124, Bari, Italy. nicola.brienza@uniba.it.'}]",Scientific reports,['10.1038/s41598-022-07085-8']
2446,35210467,Dry needling in active or latent trigger point in patients with neck pain: a randomized clinical trial.,"The purpose was to determine the efficacy of deep dry needling (DDN) applied on an active myofascial trigger point (MTrP) versus a latent-MTrP versus a non-MTrP location, on pain reduction and cervical disability, in patients with chronic neck pain. A randomized, double-blind clinical trial design was used. A sample of 65 patients was divided into non-MTrP-DDN, active-MTrP-DDN and latent-MTrP-DDN groups. The visual analog scale (VAS), reproduction of the patient's pain, number of local twitch responses, pressure pain threshold (PPT) and Neck Disability Index (NDI) were assessed before, during and after the intervention and up to 1 month post-intervention. The active-MTrP-DDN-group reduced pain intensity more than non-MTrP-DDN-group after a week and a month (P < 0.01), as well as showing the greatest improvement in tibialis muscle PPT. The treatment of both Active and Latent MTrPs was associated with the reproduction of the patient's pain. The application of DDN on an active-MTrP in the upper trapezius muscle shows greater improvements in pain intensity after 1 week and 1 month post-intervention, compared to DDN applied in latent-MTrPs or outside of MTrPs in patients with neck pain.",2022,"The application of DDN on an active-MTrP in the upper trapezius muscle shows greater improvements in pain intensity after 1 week and 1 month post-intervention, compared to DDN applied in latent-MTrPs or outside of MTrPs in patients with neck pain.","['patients with neck pain', 'patients with chronic neck pain', '65 patients was divided into non-MTrP-DDN, active-MTrP-DDN and latent-MTrP-DDN groups']","['deep dry needling (DDN', 'Dry needling']","['pain intensity', ""visual analog scale (VAS), reproduction of the patient's pain, number of local twitch responses, pressure pain threshold (PPT) and Neck Disability Index (NDI"", 'tibialis muscle PPT', 'pain reduction and cervical disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",65.0,0.106513,"The application of DDN on an active-MTrP in the upper trapezius muscle shows greater improvements in pain intensity after 1 week and 1 month post-intervention, compared to DDN applied in latent-MTrPs or outside of MTrPs in patients with neck pain.","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Martín-Sacristán', 'Affiliation': 'Department of Physical Therapy, Alcalá University, Alcalá de Henares, Madrid, Spain. luis@saluteca.com.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Complutense University of Madrid, Madrid, Spain. cescalvo@ucm.es.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pecos-Martín', 'Affiliation': 'Department of Physical Therapy, Alcalá University, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Josué', 'Initials': 'J', 'LastName': 'Fernández-Carnero', 'Affiliation': 'Physiotherapy and Pain Group, Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Rey Juan Carlos University, Móstoles, Madrid, Spain. josue.fernandez@urjc.es.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Alonso-Pérez', 'Affiliation': 'Universidad Europea de Madrid, Faculty of Sport Sciences, Villaviciosa de Odón, 28670, Madrid, Spain.'}]",Scientific reports,['10.1038/s41598-022-07063-0']
2447,35211291,Brace  versus  cast following surgical treatment of distal radial fracture: a prospective randomised study comparing quality of recovery.,"Background : Immobilisation following surgical treatment of distal radial fractures (DRF) is traditionally performed with a dorsal cast splint. There is an interest in changing the rigid cast to a removable brace. This can reduce the risk for cast-corrections, complications and improve recovery of function. The aim of the study was to compare quality of recovery (QoR) between brace and traditional cast for immobilisation during the first postoperative week.  Methods:  60 patients with American Society of Anesthesiologists (ASA) physical status 1-3, scheduled for surgical treatment of DRF under a supraclavicular block (SCB) in a day-surgery setting were randomised into two groups of immobilisation post-surgery; brace (n=30)  versus  traditional cast (n=30). Study objectives were: differences in self-assessed QoR using the QoR-15 questionnaire, postoperative oral oxycodone consumption, perioperative time events and unplanned healthcare contacts one week postoperatively.  Results : 54 patients, 46 females/eight males were included in the analysis; 27 with brace and 27 with traditional cast. QoR-15 median scores improved significantly from baseline/preoperative to day 7 (brace p=0.001, cast p=0.001) with no differences between the two groups. The only difference found was that patients in the brace group had significantly worse pain score 24-hours post-surgery (p=0.022). No significant differences were seen in total median oxycodone consumption the first three postoperative days. No differences were found in perioperative events or unplanned healthcare contacts.  Conclusions : Brace appears to be a feasible option to traditional cast for immobilisation following surgical treatment of DRF. The early QoR was similar in both groups apart from more pain in the brace group the first 24 postoperative hours.",2021,The early QoR was similar in both groups apart from more pain in the brace group the first 24 postoperative hours.,"['60 patients with American Society of Anesthesiologists (ASA) physical status 1-3, scheduled for surgical treatment of DRF under a supraclavicular block (SCB) in a day-surgery setting', 'distal radial fractures (DRF', '27 with brace and 27 with traditional cast', 'distal radial fracture', '54 patients, 46 females/eight males were included in the analysis']","['immobilisation post-surgery; brace (n=30)  versus  traditional cast', 'Brace  versus  cast']","['pain', 'pain score 24-hours post-surgery', 'QoR-15 sum median scores', 'sum median oxycodone consumption', 'self-assessed QoR using the QoR-15 questionnaire, postoperative oral oxycodone consumption, perioperative time events and unplanned healthcare contacts one week postoperatively', 'perioperative events or unplanned healthcare contacts', 'quality of recovery (QoR', 'early QoR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C0282046', 'cui_str': 'Day Surgery'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0179686', 'cui_str': 'Cast'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",60.0,0.0823221,The early QoR was similar in both groups apart from more pain in the brace group the first 24 postoperative hours.,"[{'ForeName': 'Irén', 'Initials': 'I', 'LastName': 'Sellbrant', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, 431 30, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Blomstrand', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, 431 30, Sweden.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Karlsson', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, 431 30, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Nellgård', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, 431 30, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Jakobsson', 'Affiliation': 'Department of Anaesthesia & Intensive Care, Institute of Clinical Science, Karolinska Institute, Danderyd University Hospital, Stockholm, 182 88, Sweden.'}]",F1000Research,['10.12688/f1000research.52046.2']
2448,35211872,Efficacy and Safety Outcomes with Diroximel Fumarate After Switching from Prior Therapies or Continuing on DRF: Results from the Phase 3 EVOLVE-MS-1 Study.,"INTRODUCTION


Diroximel fumarate (DRF) is an oral fumarate for relapsing multiple sclerosis (MS) with the same active metabolite as dimethyl fumarate (DMF). DRF has a safety/efficacy profile similar to DMF but with improved gastrointestinal (GI) tolerability and low (< 1%) treatment discontinuation due to GI adverse events (AEs). Efficacy and safety outcomes in patients who switched to DRF from other disease-modifying therapies (DMTs) have not been evaluated.
METHODS


EVOLVE-MS-1 is an ongoing, 2-year, open-label, phase 3 study of DRF in adults with relapsing-remitting MS. Patients either entered as newly enrolled to DRF trials, or from the 5-week, randomized, head-to-head, phase 3 EVOLVE-MS-2 study of DRF and DMF. This analysis evaluated safety and GI tolerability in patients continuing on DRF (DRF-rollover) or switching from DMF (DMF-rollover) following EVOLVE-MS-2. Safety and efficacy were evaluated in a subset of newly enrolled patients who had received prior glatiramer acetate (GA; GA/DRF) or interferons (IFN; IFN/DRF) as their most recent DMT, prior to switching to DRF in EVOLVE-MS-1.
RESULTS


As of September 1, 2020, 1057 patients were enrolled in EVOLVE-MS-1, including 166, 182, 239, and 225 patients in the GA/DRF, IFN/DRF, DRF-rollover, and DMF-rollover groups, respectively. Treatment discontinuation due to GI AEs was < 1% in all groups. GA/DRF and IFN/DRF patients experienced improvements from baseline in clinical and radiological efficacy outcomes, including significantly reduced annualized relapse rates. Rollover patients had low rates of new or recurrent GI AEs (DRF-rollover, 26.8%/4.2%; DMF-rollover, 27.1%/4.9%).
CONCLUSION


After 2 years of DRF exposure, patients with prior GA, IFN, or fumarate treatment had safety outcomes consistent with previous fumarate studies. Efficacy in patients with prior GA or IFN treatment was consistent with previous fumarate studies. The data suggest that transition to DRF from GA, IFN, or DMF is a reasonable treatment strategy, with low rates of discontinuation due to GI AEs.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02634307). INFOGRAPHIC.",2022,Treatment discontinuation due to GI AEs was < 1% in all groups.,"['adults with relapsing-remitting MS', 'patients who switched to DRF from other disease-modifying therapies (DMTs', 'patients with prior GA or', 'newly enrolled patients who had received prior', '1057 patients were enrolled in EVOLVE-MS-1, including 166, 182, 239, and 225 patients in the GA/DRF, IFN/DRF, DRF-rollover, and DMF-rollover groups, respectively', 'Patients either entered as newly enrolled to DRF trials, or from the 5-week, randomized, head-to-head, phase\xa03 EVOLVE-MS-2 study of DRF and DMF', 'patients continuing on DRF (DRF-rollover) or switching from DMF (DMF-rollover']","['DRF', 'glatiramer acetate (GA; GA/DRF) or interferons (IFN; IFN/DRF', 'Diroximel Fumarate', 'IFN', 'Diroximel fumarate (DRF']","['Efficacy and Safety Outcomes', 'annualized relapse rates', 'low rates of new or recurrent GI AEs', 'gastrointestinal (GI) tolerability', 'Efficacy and safety outcomes', 'safety and GI tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0289884', 'cui_str': 'glatiramer acetate'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0289884', 'cui_str': 'glatiramer acetate'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1057.0,0.115609,Treatment discontinuation due to GI AEs was < 1% in all groups.,"[{'ForeName': 'Sibyl', 'Initials': 'S', 'LastName': 'Wray', 'Affiliation': 'Hope Neurology MS Center, Knoxville, TN, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Then Bergh', 'Affiliation': 'Department of Neurology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Wundes', 'Affiliation': 'Department of Neurology, University of Washington Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'Montreal Neurological Institute, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Drulovic', 'Affiliation': 'Clinic of Neurology, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Elzbieta', 'Initials': 'E', 'LastName': 'Jasinska', 'Affiliation': 'Collegium Medicum UJK and Clinical Center, RESMEDICA, Kielce, Poland.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Bowen', 'Affiliation': 'Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle, WA, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Negroski', 'Affiliation': 'MS Center of Sarasota, Sarasota, FL, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Naismith', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Hunter', 'Affiliation': 'Advanced Neurosciences Institute, Franklin, TN, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gudesblatt', 'Affiliation': 'South Shore Neurologic Associates, Patchogue, NY, USA.'}, {'ForeName': 'Hailu', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Biogen, 225 Binney St, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lyons', 'Affiliation': 'Biogen, 225 Binney St, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Sai L', 'Initials': 'SL', 'LastName': 'Shankar', 'Affiliation': 'Biogen, 225 Binney St, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Kapadia', 'Affiliation': 'Biogen, 225 Binney St, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Mendoza', 'Affiliation': 'Biogen, 225 Binney St, Cambridge, MA, 02142, USA. jason.mendoza@biogen.com.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Singer', 'Affiliation': 'The MS Center for Innovations in Care, Missouri Baptist Medical Center, St. Louis, MO, USA.'}]",Advances in therapy,['10.1007/s12325-022-02068-7']
2449,35212308,Early complementary acupuncture improves the clinical prognosis of traumatic brain edema: A randomized controlled trial.,"BACKGROUND


Traumatic brain edema occurs commonly brain injury, and most manifests as pericontusional edema of brain contusions. On the basis of evidence-based medicine, apart from recommending craniotomy and mannitol, there are few particularly effective measures to prevent and treat traumatic brain edema. It is uncertain whether an early complementary acupuncture treatment would improve long-term outcomes of patients with traumatic brain edema. The aim of this study is to assess the efficacy and the safety of early complementary acupuncture for patients with traumatic brain edema.
METHODS


This study is an actively accruing, single-center, single-blinded, 2-arm, randomized controlled trial. Patients with traumatic brain injury, a Glasgow Coma Scale score of 6∼12, and brain edema on computed tomography scan will be divided into 2 groups on the basis of stratified block randomization. All patients will receive conventional treatment, and the study group will undergo additional acupuncture therapy (start within 72 hours after the injury) once a day for 28 days. The primary outcome is the dichotomized Glasgow Outcome Score at 6 months and 12 months after injury, and the secondary outcomes are the Glasgow Coma Scale, the volume of traumatic brain edema, the serum levels of C-reactive protein and interleukin-6, and the Modified Barthel Index.
DISCUSSION


This study will provide data regarding the efficacy of early complementary acupuncture for traumatic brain edema. If the study yields positive results, its findings may offer insights into a valuable complementary option of acupuncture for traumatic brain edema that could provide pilot evidence for large, randomized, controlled trials.Trial registration: This trial has been published in the Chinese Clinical Trial Register, http://www.chictr.org.cn/edit.aspx?pid=141208&htm=4 (Identifier: ChiCTR2100053794, registered on December 3, 2021).",2022,"The primary outcome is the dichotomized Glasgow Outcome Score at 6 months and 12 months after injury, and the secondary outcomes are the Glasgow Coma Scale, the volume of traumatic brain edema, the serum levels of C-reactive protein and interleukin-6, and the Modified Barthel Index.
","['traumatic brain edema', 'Patients with traumatic brain injury, a Glasgow Coma Scale score of 6∼12, and brain edema on computed tomography scan', 'patients with traumatic brain edema']","['acupuncture', 'acupuncture therapy']","['dichotomized Glasgow Outcome Score at 6\u200amonths and 12\u200amonths after injury, and the secondary outcomes are the Glasgow Coma Scale, the volume of traumatic brain edema, the serum levels of C-reactive protein and interleukin-6, and the Modified Barthel Index']","[{'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}]",,0.363418,"The primary outcome is the dichotomized Glasgow Outcome Score at 6 months and 12 months after injury, and the secondary outcomes are the Glasgow Coma Scale, the volume of traumatic brain edema, the serum levels of C-reactive protein and interleukin-6, and the Modified Barthel Index.
","[{'ForeName': 'Zi-Quan', 'Initials': 'ZQ', 'LastName': 'Guo', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': ""Department of Acupuncture of Qionghai People's Hospital, Qionghai, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hong-Mei', 'Initials': 'HM', 'LastName': 'Gu', 'Affiliation': 'School of Public Health, Mudanjiang Medical College, Mudanjiang, China.'}, {'ForeName': 'Wen-Bin', 'Initials': 'WB', 'LastName': 'Wang', 'Affiliation': ""Neurosurgery Center of Qionghai People's Hospital, Qionghai, China.""}, {'ForeName': 'Tai-Dong', 'Initials': 'TD', 'LastName': 'Chen', 'Affiliation': ""Neurosurgery Center of Qionghai People's Hospital, Qionghai, China.""}]",Medicine,['10.1097/MD.0000000000028959']
2450,35212300,Effect of platelet-rich plasma injections for chronic nonspecific low back pain: A randomized controlled study.,"BACKGROUND


Patient with chronic nonspecific low back pain is weakened ligament, and prolotherapy is the effective treatment but their use remains controversial. These ligaments can be strengthened by platelet-rich plasma injection. We hypothesized that the effectiveness of platelet-rich plasma injection and prolotherapy may decrease pain and improved disability of patient with chronic low back pain.
METHODS


This study was a prospective, double-blind, randomized controlled trial and was conducted for 3 years for patient enroll and follow-up. Thirty-four patients with chronic nonspecific low back pain (duration of at least 3 months) refectory to conventional management were randomized to platelet-rich plasma injection and lidocaine injection. Patients were treated with weekly platelet-rich plasma or lidocaine injections at the lumbopelvic ligaments for 2 weeks and then weekly prolotherapy with 15% glucose for 2 weeks and followed up 6 months. Visual analog scale, Oswestry Disability Index, and Roland-Morris Disability Questionnaire were evaluated at initial, 4 weeks, 3 months, and 6 months. Four patients did not complete this trial. Three were in the platelet-rich plasma injection and 1 was in the lidocaine injection.
RESULTS


The intensity of pain was significantly decreased in platelet-rich plasma injections at 6 months as compared lidocaine injections; between-group differences were 0.9 (95% confidence interval 0.10-1.75 [P = .027]). All participants were significantly decreased pain and disability index at 4 weeks, 3 months, and 6 months but there were no significant differences between groups except for visual analog scale at 6 months. The baseline parameters were no significant differences in both groups.
CONCLUSIONS


In chronic nonspecific low back pain, the platelet-rich plasma injection in combination with prolotherapy is an effective intervention and either lidocaine or platelet-rich plasma injection significantly reduced disability. And injection at the lumbopelvic ligaments using the platelet-rich plasma and prolotherapy is also an effective treatment for pain.",2022,"All participants were significantly decreased pain and disability index at 4 weeks, 3 months, and 6 months","['Thirty-four patients with chronic nonspecific low back pain (duration of at least 3 months) refectory to conventional management', 'chronic nonspecific low back pain', 'patient with chronic low back pain', '3\u200ayears for patient enroll and follow-up']","['lidocaine', 'platelet-rich plasma injection and lidocaine injection', 'platelet-rich plasma injections', 'platelet-rich plasma injection and prolotherapy', 'platelet-rich plasma or lidocaine injections']","['Visual analog scale, Oswestry Disability Index, and Roland-Morris Disability Questionnaire', 'visual analog scale', 'platelet-rich plasma injections', 'intensity of pain', 'pain and disability index']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4049857', 'cui_str': 'Lidocaine Injection'}, {'cui': 'C0500223', 'cui_str': 'Prolotherapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",34.0,0.0653252,"All participants were significantly decreased pain and disability index at 4 weeks, 3 months, and 6 months","[{'ForeName': 'Sun Jae', 'Initials': 'SJ', 'LastName': 'Won', 'Affiliation': ""Department of Rehabilitation Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Da-Ye', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': ""Department of Rehabilitation Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jae Min', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': ""Department of Rehabilitation Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]",Medicine,['10.1097/MD.0000000000028935']
2451,35212286,"Do synbiotics really enhance beneficial synbiotics effect on defecation symptoms in healthy adults?: Randomized, double-blind, placebo-controlled trial.","GOALS


We examined whether synbiotics enhance improvement by probiotics.
BACKGROUND


Probiotics, which are beneficial microbacteria, are a nutritional intervention for treatment of functional constipation or its tendency. Prebiotics, meanwhile, can promote the proliferation of probiotics in the gastrointestinal tract and enhance their beneficial effects. Synbiotics, a combination of probiotics and prebiotics, may be superior to probiotics in the treatment of defecation-related symptoms, but this requires elucidation.
STUDY


This randomized, double-blind, placebo-controlled study enrolled 69 healthy adults with constipation tendency. Participants were allocated to either control, probiotics, or synbiotics groups and they recorded details of their defecations and their condition. The first 2 weeks were the observation period and the latter 2 weeks were the intervention period, in which participants took test foods. Probiotic foods included Bifidobacterium longum NT strain (1010 CFU/day), synbiotic foods included the NT strain (1010 CFU/day) and galactooligosaccharide (1 g/day). Placebo foods contained the vehicle only. Participants answered questionnaires (Patient Assessment on Constipation Symptoms [PAC-SYM], and one on dietary history) on the last day of each period.
RESULTS


Nine participants withdrew consent, and 2 of the remaining 60 had missing data. Age, body mass index, and sex were not significantly different between the 3 groups. Frequency of bowel movements in the fourth week, the primary endpoint, was not increased in the probiotics or synbiotics groups compared with the control group, and the frequency of bowel movements and days with defecation were not changed by probiotics or synbiotics during the intervention period. Probiotics and synbiotics did not improve stool conditions, although incomplete defecation was improved by probiotics but not by synbiotics compared with placebo. PAC-SYM indicated that stool condition and total scores were improved by probiotics but not by synbiotics during the intervention compared with placebo.
CONCLUSION


The probiotic strain Bifidobacterium longum NT can improve constipation symptoms, especially stool condition, but it does not increase bowel movement frequency in healthy adults with constipation tendency. Synbiotics treatment seemed to diminish this improvement of constipation induced by probiotics. This study indicates the possibility of attenuation of beneficial effects from probiotics by the use of synbiotics, contrary to synbiotics theory.",2022,"Probiotics and synbiotics did not improve stool conditions, although incomplete defecation was improved by probiotics but not by synbiotics compared with placebo.","['69 healthy adults with constipation tendency', 'healthy adults with constipation tendency', 'healthy adults']","['placebo', 'probiotic strain Bifidobacterium longum NT', 'Placebo', 'galactooligosaccharide', 'control, probiotics, or synbiotics']","['Constipation Symptoms', 'stool conditions', 'stool condition and total scores', 'constipation symptoms', 'Frequency of bowel movements', 'incomplete defecation', 'frequency of bowel movements and days with defecation', 'defecation symptoms', 'constipation']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",69.0,0.149284,"Probiotics and synbiotics did not improve stool conditions, although incomplete defecation was improved by probiotics but not by synbiotics compared with placebo.","[{'ForeName': 'Daisaku', 'Initials': 'D', 'LastName': 'Ito', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Kimiidera 811-1 Wakayama, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Anatomy and Cell Biology, Wakayama Medical University, Kimiidera 811-1 Wakayama, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Maekita', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Kimiidera 811-1 Wakayama, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Yamagishi', 'Affiliation': 'Department of Anatomy and Cell Biology, Wakayama Medical University, Kimiidera 811-1 Wakayama, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Kawashima', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Wakayama Medical University, Kimiidera 811-1 Wakayama, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Clinical Study Support Center, Wakayama Medical University, Kimiidera 811-1 Wakayama, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Tanioka', 'Affiliation': 'Clinical Study Support Center, Wakayama Medical University, Kimiidera 811-1 Wakayama, Japan.'}, {'ForeName': 'Takeichi', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Kimiidera 811-1 Wakayama, Japan.'}, {'ForeName': 'Mikitaka', 'Initials': 'M', 'LastName': 'Iguchi', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Kimiidera 811-1 Wakayama, Japan.'}, {'ForeName': 'Kosei', 'Initials': 'K', 'LastName': 'Kunitatsu', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Wakayama Medical University, Kimiidera 811-1 Wakayama, Japan.'}, {'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Kanai', 'Affiliation': 'Department of Anatomy and Cell Biology, Wakayama Medical University, Kimiidera 811-1 Wakayama, Japan.'}, {'ForeName': 'Seiya', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Wakayama Medical University, Kimiidera 811-1 Wakayama, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kitano', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Kimiidera 811-1 Wakayama, Japan.'}]",Medicine,['10.1097/MD.0000000000028858']
2452,35212470,Health-related quality of life of female sex workers living with HIV in South Africa: a cross-sectional study.,"INTRODUCTION


Health-related quality of life (HRQoL) is an important HIV outcome beyond viral suppression. However, there are limited data characterizing HRQoL of key populations, including female sex workers (FSW) living with HIV.
METHODS


We used baseline data (22 June 2018-23 March 2020) of FSW who were diagnosed with HIV and enrolled into a randomized trial in Durban, South Africa. HRQoL information was collected by a generic preference-accompanied tool with five domains (EQ-5D), and summarized into a single score (range 0-1), which represents health utility. We employed multivariable beta regression models to identify determinants of HRQoL and to estimate subgroup-specific HRQoL score. Using external estimates of life expectancy and population size, we estimated the number of quality adjusted life years reduced among FSW living with HIV in South Africa associated with violence and drug use.
RESULTS


Of 1,363 individuals (mean age: 32.4 years; mean HRQoL score: 0.857) in our analysis, 62.6% used drugs, 61.3% experienced physical or sexual violence and 64.6% self-reported taking antiretroviral treatment (ART). The following were associated with a reduction in the average marginal HRQoL score: older age (per decade: 0.018 [95% confidence interval (CI): 0.008, 0.027]), drug use (0.022 [0.007, 0.036]), experience of violence (0.024 [0.010, 0.038]) and moderate (vs. no) level of internalized stigma (0.023 [0.004, 0.041]). Current ART use was associated with a 0.015-point (-0.001, 0.031) increase in the HRQoL score. The estimated mean (95% CI) HRQoL scores ranged from 0.838 (0.816, 0.860) for FSW who used drugs, experienced violence and were not on ART; to 0.899 (0.883, 0.916) for FSW who did not use drugs nor experience violence and were on ART. Our results can be translated into a reduction in 37,184 and 39,722 quality adjusted life years related to drug use and experience of violence, respectively, in South Africa.
CONCLUSIONS


These results demonstrate the association of ART with higher HRQoL among FSW and the need to further address structural risks, including drug use, violence and stigma. Population-specific estimates of HRQoL score can be further used to calculate quality-adjusted life years in economic evaluations of individual and structural interventions addressing the needs of FSW living with HIV.
CLINICAL TRIAL REGISTRATION


NCT03500172 (April 17, 2018).",2022,"The following were associated with a reduction in the average marginal HRQoL score: older age (per decade: 0.018 [95% confidence interval (CI): 0.008, 0.027]), drug use (0.022 [0.007, 0.036]), experience of violence (0.024 [0.010, 0.038]) and moderate (vs. no) level of internalized stigma (0.023 [0.004, 0.041]).","['female sex workers (FSW) living with HIV', '22 June 2018-23 March 2020) of FSW who were diagnosed with HIV and enrolled into a randomized trial in Durban, South Africa', 'female sex workers living with HIV in South Africa', 'Of 1,363 individuals (mean age: 32.4 years; mean HRQoL score: 0.857) in our analysis, 62.6% used drugs, 61.3% experienced physical or sexual violence and 64.6% self-reported taking antiretroviral treatment (ART']",[],"['average marginal HRQoL score: older age', 'HRQoL information', 'experience of violence', 'internalized stigma', 'HRQoL score']","[{'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",,0.113273,"The following were associated with a reduction in the average marginal HRQoL score: older age (per decade: 0.018 [95% confidence interval (CI): 0.008, 0.027]), drug use (0.022 [0.007, 0.036]), experience of violence (0.024 [0.010, 0.038]) and moderate (vs. no) level of internalized stigma (0.023 [0.004, 0.041]).","[{'ForeName': 'Linwei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""MAP-Centre for Urban Health Solutions, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Carly A', 'Initials': 'CA', 'LastName': 'Comins', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Young', 'Affiliation': 'TB HIV Care, Cape Town, South Africa.'}, {'ForeName': 'Mfezi', 'Initials': 'M', 'LastName': 'Mcingana', 'Affiliation': 'TB HIV Care, Cape Town, South Africa.'}, {'ForeName': 'Ntambue', 'Initials': 'N', 'LastName': 'Mulumba', 'Affiliation': 'TB HIV Care, Cape Town, South Africa.'}, {'ForeName': 'Hlengiwe', 'Initials': 'H', 'LastName': 'Mhlophe', 'Affiliation': 'TB HIV Care, Cape Town, South Africa.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Hausler', 'Affiliation': 'TB HIV Care, Cape Town, South Africa.'}, {'ForeName': 'Sheree R', 'Initials': 'SR', 'LastName': 'Schwartz', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Baral', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Sharmistha', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': ""MAP-Centre for Urban Health Solutions, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""MAP-Centre for Urban Health Solutions, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}]",Journal of the International AIDS Society,['10.1002/jia2.25884']
2453,35212633,Text Messaging Intervention for Mental Wellness in American Indian and Alaska Native Teens and Young Adults (BRAVE Study): Analysis of User Engagement Patterns.,"BACKGROUND


Many American Indian and Alaska Native (AI/AN or Native) communities express concern about high rates of suicide and poor mental health. Technology-based health interventions that nurture resilience, coping skills, connectedness, and help-seeking skills may be an effective strategy for promoting health and wellbeing among AI/AN youth. The Northwest Portland Area Indian Health Board designed the BRAVE intervention for AI/AN youth. BRAVE is delivered via SMS text messaging and includes role model videos, mental wellness strategies, links to culturally relevant resources, and social support from family and friends.
OBJECTIVE


The aim of this study is to explore system data from the BRAVE intervention to determine patterns of user engagement and differences in psychosocial outcomes based on the number of clicks on BRAVE content.
METHODS


The BRAVE study included 1030 AI/AN teens and young adults nationwide (15 to 24 years old). The message series in the BRAVE and STEM study arms included 3 to 5 SMS text messages per week, featuring 1 role model video and 1 image per week. Messages were sent out via Mobile Commons (Upland Software Inc), a mobile messaging provider that supports text, picture, and video SMS.
RESULTS


Of the 509 participants in the original BRAVE analysis, 270 had sufficient data to analyze user engagement, with at least 1 trackable click on a study SMS text message. Of the 270, 184 (68.1%) were female, 50 (18.5%) were male, and 36 (13.3%) selected another gender category. The average participant was 20.6 years old, with a minimum and maximum age of 15 and 26 years. Most participants had relatively low engagement measured by the number of clicks (median 2; mean 3.4), although others clicked message content as many as 49 times. Users engaged most frequently with the YouTube-based content (viewing 1 of 7 role model videos), with 64.8% (175/270) of total clicks coming from the role model videos, and earlier episodes receiving the highest number of clicks. Most baseline psychosocial measures were not significantly associated with the number of links clicked. However, help-seeking behavior was highly significant (P<.001), with a rate ratio of 0.82 (0.73, 0.92), indicating that each 1-unit increase in help-seeking score at baseline was associated with an 18% decrease in the expected number of study content clicks.
CONCLUSIONS


This is the first study to set initial standards for assessing user engagement in an mHealth intervention. Our work underscores the feasibility of exploring the impact of engagement on intended outcomes, allowing for more precise exploration of the dose-response relationship that may be realized through these low-touch interventions that offer promising potential for reaching high numbers of program participants.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04979481; https://clinicaltrials.gov/ct2/show/NCT04979481.",2022,"However, help-seeking behavior was highly significant (P<.001), with a rate ratio of 0.82 (0.73, 0.92), indicating that each 1-unit increase in help-seeking score at baseline was associated with an 18% decrease in the expected number of study content clicks.
","['Of the 270, 184 (68.1%) were female, 50 (18.5%) were male, and 36 (13.3%) selected another gender category', '509 participants in the original BRAVE analysis', 'The average participant was 20.6 years old, with a minimum and maximum age of 15 and 26 years', 'Many American Indian and Alaska Native', 'American Indian and Alaska Native Teens and Young Adults (BRAVE Study', '1030 AI/AN teens and young adults nationwide (15 to 24 years old']",['Text Messaging Intervention'],"['help-seeking behavior', 'help-seeking score']","[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0683301', 'cui_str': 'Help-Seeking Behavior'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1030.0,0.0814612,"However, help-seeking behavior was highly significant (P<.001), with a rate ratio of 0.82 (0.73, 0.92), indicating that each 1-unit increase in help-seeking score at baseline was associated with an 18% decrease in the expected number of study content clicks.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wrobel', 'Affiliation': 'Colorado School of Public Health, University of Colorado, Aurora, CO, United States.'}, {'ForeName': 'Joshva', 'Initials': 'J', 'LastName': 'Silvasstar', 'Affiliation': 'Colorado School of Public Health, University of Colorado, Aurora, CO, United States.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Peterson', 'Affiliation': 'Northwest Portland Area Indian Health Board, Portland, OR, United States.'}, {'ForeName': 'Kanku', 'Initials': 'K', 'LastName': 'Sumbundu', 'Affiliation': 'Colorado School of Public Health, University of Colorado, Aurora, CO, United States.'}, {'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Kelley', 'Affiliation': 'Allyson Kelley and Associates PLLC, Sisters, OR, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stephens', 'Affiliation': 'Northwest Portland Area Indian Health Board, Portland, OR, United States.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Craig Rushing', 'Affiliation': 'Northwest Portland Area Indian Health Board, Portland, OR, United States.'}, {'ForeName': 'Sheana', 'Initials': 'S', 'LastName': 'Bull', 'Affiliation': 'Colorado School of Public Health, University of Colorado, Aurora, CO, United States.'}]",JMIR formative research,['10.2196/32138']
2454,35212621,A peer-delivered intervention to reduce harm and improve the well-being of homeless people with problem substance use: the SHARPS feasibility mixed-methods study.,"BACKGROUND


For people experiencing homelessness and problem substance use, access to appropriate services can be challenging. There is evidence that development of trusting relationships with non-judgemental staff can facilitate service engagement. Peer-delivered approaches show particular promise, but the evidence base is still developing. This study tested the feasibility and acceptability of a peer-delivered intervention, through 'Peer Navigators', to support people who are homeless with problem substance use to address a range of health and social issues.
OBJECTIVES


The study objectives were to design and implement a peer-delivered, relational intervention to reduce harms and improve health/well-being, quality of life and social functioning for people experiencing homelessness and problem substance use, and to conduct a concurrent process evaluation to inform a future randomised controlled trial.
DESIGN


A mixed-methods feasibility study with concurrent process evaluation was conducted, involving qualitative interviews [staff interviews (one time point),  n  = 12; Peer Navigator interviews (three or four time points),  n  = 15; intervention participant interviews: first time point,  n  = 24, and second time point,  n  = 10], observations and quantitative outcome measures.
SETTING


The intervention was delivered in three outreach services for people who are homeless in Scotland, and three Salvation Army hostels in England; there were two standard care settings: an outreach service in Scotland and a hostel in England.
PARTICIPANTS


Participants were people experiencing homelessness and problem substance use ( n  = 68) (intervention).
INTERVENTION


This was a peer-delivered, relational intervention drawing on principles of psychologically informed environments, with Peer Navigators providing practical and emotional support.
MAIN OUTCOME MEASURES


Outcomes relating to participants' substance use, participants' physical and mental health needs, and the quality of Peer Navigator relationships were measured via a 'holistic health check', with six questionnaires completed at two time points: a specially created sociodemographic, health and housing status questionnaire; the Patient Health Questionnaire-9 items plus the Generalised Anxiety Disorder-7; the Maudsley Addiction Profile; the Substance Use Recovery Evaluator; the RAND Corporation Short Form survey-36 items; and the Consultation and Relational Empathy Measure.
RESULTS


The Supporting Harm Reduction through Peer Support (SHARPS) study was found to be acceptable to, and feasible for, intervention participants, staff and Peer Navigators. Among participants, there was reduced drug use and an increase in the number of prescriptions for opioid substitution therapy. There were reductions in risky injecting practice and risky sexual behaviour. Participants reported improvements to service engagement and felt more equipped to access services on their own. The lived experience of the Peer Navigators was highlighted as particularly helpful, enabling the development of trusting, authentic and meaningful relationships. The relationship with the Peer Navigator was measured as excellent at baseline and follow-up. Some challenges were experienced in relation to the 'fit' of the intervention within some settings and will inform future studies.
LIMITATIONS


Some participants did not complete the outcome measures, or did not complete both sets, meaning that we do not have baseline and/or follow-up data for all. The standard care data sample sizes make comparison between settings limited.
CONCLUSIONS


A randomised controlled trial is recommended to assess the effectiveness of the Peer Navigator intervention.
FUTURE WORK


A definitive cluster randomised controlled trial should particularly consider setting selection, outcomes and quantitative data collection instruments.
TRIAL REGISTRATION


This trial is registered as ISRCTN15900054.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 26, No. 14. See the NIHR Journals Library website for further project information.",2022,"This study tested the feasibility and acceptability of a peer-delivered intervention, through 'Peer Navigators', to support people who are homeless with problem substance use to address a range of health and social issues.
","['people who are homeless with problem substance', 'Participants were people experiencing homelessness and problem substance use ( n \u2009=\u200968) (intervention', 'people who are homeless in Scotland, and three Salvation Army hostels in England; there were two standard care settings: an outreach service in Scotland and a hostel in England', 'homeless people with problem substance use']","['relational intervention drawing on principles of psychologically informed environments, with Peer Navigators providing practical and emotional support', 'relational intervention', ""peer-delivered intervention, through 'Peer Navigators""]","['risky injecting practice and risky sexual behaviour', 'number of prescriptions for opioid substitution therapy', 'service engagement and felt more equipped to access services', ""participants' substance use, participants' physical and mental health needs, and the quality of Peer Navigator relationships were measured via a 'holistic health check', with six questionnaires completed at two time points: a specially created sociodemographic, health and housing status questionnaire; the Patient Health Questionnaire-9 items plus the Generalised Anxiety Disorder-7; the Maudsley Addiction Profile; the Substance Use Recovery Evaluator; the RAND Corporation Short Form survey-36 items; and the Consultation and Relational Empathy Measure"", 'harms and improve health/well-being, quality of life and social functioning']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0442518', 'cui_str': 'Hostel'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C2936530', 'cui_str': 'Opioid Substitution Treatment'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019844', 'cui_str': 'Wholistic Health'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0585663', 'cui_str': 'Maudsley addiction profile'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",,0.152769,"This study tested the feasibility and acceptability of a peer-delivered intervention, through 'Peer Navigators', to support people who are homeless with problem substance use to address a range of health and social issues.
","[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Parkes', 'Affiliation': 'Salvation Army Centre for Addiction Services and Research, Faculty of Social Sciences, University of Stirling, Stirling, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Matheson', 'Affiliation': 'Salvation Army Centre for Addiction Services and Research, Faculty of Social Sciences, University of Stirling, Stirling, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Carver', 'Affiliation': 'Salvation Army Centre for Addiction Services and Research, Faculty of Social Sciences, University of Stirling, Stirling, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Foster', 'Affiliation': 'Salvation Army Centre for Addiction Services and Research, Faculty of Social Sciences, University of Stirling, Stirling, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Budd', 'Affiliation': 'Faculty of Medicine, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Liddell', 'Affiliation': 'The Scottish Drugs Forum, Glasgow, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Wallace', 'Affiliation': 'The Scottish Drugs Forum, Glasgow, UK.'}, {'ForeName': 'Bernie', 'Initials': 'B', 'LastName': 'Pauly', 'Affiliation': 'The Canadian Institute for Substance Use Research, University of Victoria, Greater Victoria, BC, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fotopoulou', 'Affiliation': 'Faculty of Social Sciences, University of Stirling, Stirling, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Burley', 'Affiliation': 'Faculty of Medicine, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Anderson', 'Affiliation': 'Faculty of Social Sciences, University of Stirling, Stirling, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'The Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Aberdeen, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/WVVL4786']
2455,35213459,Intraoperative Cytologic Sampling for Resected Pancreatic and Periampullary Adenocarcinoma with Implications for Locoregional Recurrence-Free Survival.,"BACKGROUND


We hypothesized that pancreatic and periampullary adenocarcinoma recurrence after surgical resection may be affected by the shedding of malignant epithelial cells during surgical dissection and that this may have implications for disease recurrence and survival.
STUDY DESIGN


In this ongoing, investigator-initiated prospective randomized controlled trial, patients with pancreatic and periampullary adenocarcinoma were randomized intraoperatively, postresection into 3 study arms: peritoneal lavage using 10 L normal saline or distilled water, or control group with no lavage. Peritoneal fluid was sampled for cytologic analysis (cytospin, cellblock, immunohistochemistry-Ber-EP4 antibody) at 4 stages: (1) abdominal entry pre-dissection, (2) resection bed after tumor extirpation, (3) ex vivo resected specimen, and (4) resection bed postlavage.
RESULTS


Between April 2016 and May 2018, 193 patients who underwent randomization for the study also underwent the described cytologic sampling. Of these, 167 patients (86.5%) were ultimately found to have pancreatic or periampullary adenocarcinoma. Before dissection (1) on cytospin analysis, 4.9% were positive, which rose to 10.2% intraoperatively (2), 16.7% ex vivo (3), and decreased to 4.3% (4) after lavage. Lymph node metastasis, margin involvement, and perineural invasion did not correlate with locoregional recurrence (LR). Tumor cells in the ex vivo cytospin (3) correlated with LR (odds ratio 3.8 [95% CI 1.6 to 9.2], p = 0.005) and LR disease-free survival (p = 0.007). Cox regression analysis revealed ex vivo cytospin positivity to be strongly associated with poorer LR disease-free survival (hazard ratio 2.26 [95% CI 1.16 to 4.42], p = 0.017).
CONCLUSIONS


Cytologic sampling from ex vivo specimen irrigation after surgical resection of pancreatic and periampullary adenocarcinoma may have implications for LR, survival, and treatment, suggesting a possible cancer cell shedding phenotype.",2022,"Lymph node metastasis, margin involvement, and perineural invasion did not correlate with locoregional recurrence (LR).","['167 patients (86.5%) were ultimately found to have pancreatic or periampullary adenocarcinoma', 'patients with pancreatic and periampullary adenocarcinoma', '193 patients who underwent randomization for the study also underwent the described cytologic sampling', 'Between April 2016 and May 2018']","['peritoneal lavage using 10\u2009L normal saline or distilled water, or control group with no lavage']","['poorer LR disease-free survival', 'LR disease-free survival']","[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205471', 'cui_str': 'Cytologic'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0031148', 'cui_str': 'Peritoneal lavage'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.171668,"Lymph node metastasis, margin involvement, and perineural invasion did not correlate with locoregional recurrence (LR).","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Papai', 'Affiliation': 'From the Sidney Kimmel Medical College, Philadelphia, PA (Papai, CJ Yeo, Lavu).'}, {'ForeName': 'Avinoam', 'Initials': 'A', 'LastName': 'Nevler', 'Affiliation': 'the Thomas Jefferson University Hospital and the Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, PA (Nevler, Solomides, Shergill, TP Yeo, Cannaday, CJ Yeo, Lavu).'}, {'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Solomides', 'Affiliation': 'the Thomas Jefferson University Hospital and the Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, PA (Nevler, Solomides, Shergill, TP Yeo, Cannaday, CJ Yeo, Lavu).'}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Shergill', 'Affiliation': 'the Thomas Jefferson University Hospital and the Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, PA (Nevler, Solomides, Shergill, TP Yeo, Cannaday, CJ Yeo, Lavu).'}, {'ForeName': 'Theresa P', 'Initials': 'TP', 'LastName': 'Yeo', 'Affiliation': 'the Thomas Jefferson University Hospital and the Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, PA (Nevler, Solomides, Shergill, TP Yeo, Cannaday, CJ Yeo, Lavu).'}, {'ForeName': 'Shawnna', 'Initials': 'S', 'LastName': 'Cannaday', 'Affiliation': 'the Thomas Jefferson University Hospital and the Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, PA (Nevler, Solomides, Shergill, TP Yeo, Cannaday, CJ Yeo, Lavu).'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Yeo', 'Affiliation': 'From the Sidney Kimmel Medical College, Philadelphia, PA (Papai, CJ Yeo, Lavu).'}, {'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Winter', 'Affiliation': 'the University Hospitals Cleveland Medical Center, Cleveland, OH (Winter).'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Lavu', 'Affiliation': 'From the Sidney Kimmel Medical College, Philadelphia, PA (Papai, CJ Yeo, Lavu).'}]",Journal of the American College of Surgeons,['10.1097/XCS.0000000000000034']
2456,35213433,Efficacy of Near-Infrared Fluorescence-Guided Hepatectomy for the Detection of Colorectal Liver Metastases: A Randomized Controlled Trial.,"BACKGROUND


The application of indocyanine green fluorescence-guided hepatectomy for liver metastases from colorectal cancer is in the preliminary stage of clinical practice; thus, its efficacy needs to be determined. This study compared the number of intrahepatic colorectal liver metastases detected intraoperatively and postoperative recovery data between patients who underwent traditional hepatectomy (nonindocyanine green group) and traditional hepatectomy plus intraoperative indocyanine green fluorescence imaging (indocyanine green group).
STUDY DESIGN


Between January 2018 and March 2020, patients with potentially resectable colorectal liver metastases were randomly assigned to the nonindocyanine green or indocyanine green group. The number of intrahepatic colorectal liver metastases identified intraoperatively and based on postoperative recovery data were compared between both groups.
RESULTS


Overall, we recruited 80 patients, among whom 72 eligible patients were randomly assigned. After allocation, 64 patients, comprising 32 in each group, underwent the allocated intervention and follow-up. Compared with the nonindocyanine green group, the mean number of intrahepatic colorectal liver metastases identified intraoperatively in the indocyanine green group was significantly greater (mean [standard deviation], 3.03 [1.58] vs 2.28 [1.35]; p = 0.045), the postoperative hospital stay was shorter (p = 0.012) and the 1-year recurrence rate was also lower (p = 0.017). Postoperative complications and 90-day mortality were comparable, with no statistical differences.
CONCLUSIONS


Indocyanine green fluorescence imaging significantly increases the number of intrahepatic colorectal liver metastases identified and reduces postoperative hospital stay and 1-year recurrence rate without increasing hepatectomy-related complications and mortality rates.",2022,patients with potentially resectable colorectal liver metastases were randomly assigned to the nonindocyanine green or indocyanine green group.,"['80 patients, among whom 72 eligible patients', 'Colorectal Liver Metastases', 'Between January 2018 and March 2020', 'patients with potentially resectable colorectal liver metastases']","['nonindocyanine', 'traditional hepatectomy (nonindocyanine green group) and traditional hepatectomy plus intraoperative indocyanine green fluorescence imaging (indocyanine green group', 'indocyanine green fluorescence-guided hepatectomy', 'Near-Infrared Fluorescence-Guided Hepatectomy', 'Indocyanine green fluorescence imaging', 'nonindocyanine green or indocyanine green group']","['postoperative hospital stay and 1-year recurrence rate', 'number of intrahepatic colorectal liver metastases', 'Postoperative complications and 90-day mortality', '1-year recurrence rate', 'postoperative hospital stay', 'mean number of intrahepatic colorectal liver metastases']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0430876', 'cui_str': 'Ophthalmic fluorescence imaging'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C1610503', 'cui_str': 'Green Or'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",72.0,0.0872897,patients with potentially resectable colorectal liver metastases were randomly assigned to the nonindocyanine green or indocyanine green group.,"[{'ForeName': 'Kunshan', 'Initials': 'K', 'LastName': 'He', 'Affiliation': 'From the The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China (Hong, Cai, P Li, Liu, Shan, J Li).'}, {'ForeName': 'Xiaopeng', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'From the The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China (Hong, Cai, P Li, Liu, Shan, J Li).'}, {'ForeName': 'Chongwei', 'Initials': 'C', 'LastName': 'Chi', 'Affiliation': 'From the The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China (Hong, Cai, P Li, Liu, Shan, J Li).'}, {'ForeName': 'Chaonong', 'Initials': 'C', 'LastName': 'Cai', 'Affiliation': 'From the The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China (Hong, Cai, P Li, Liu, Shan, J Li).'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'An', 'Affiliation': 'From the The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China (Hong, Cai, P Li, Liu, Shan, J Li).'}, {'ForeName': 'Peiping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'From the The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China (Hong, Cai, P Li, Liu, Shan, J Li).'}, {'ForeName': 'Xialei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'From the The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China (Hong, Cai, P Li, Liu, Shan, J Li).'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Shan', 'Affiliation': 'From the The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China (Hong, Cai, P Li, Liu, Shan, J Li).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'From the The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China (Hong, Cai, P Li, Liu, Shan, J Li).'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'From the The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China (Hong, Cai, P Li, Liu, Shan, J Li).'}]",Journal of the American College of Surgeons,['10.1097/XCS.0000000000000029']
2457,35214772,"A Multi-Center, Randomised, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Impact of BCG Re-Vaccination on the Incidence and Severity of SARS-CoV-2 Infections among Symptomatic Healthcare Professionals during the COVID-19 Pandemic in Poland-First Results.","Tuberculosis vaccines (Bacillus Calmette-Guérin, BCG) were introduced 100 years ago and are still recommended by the World Health Organization to prevent the disease. Studies have shown that BCG vaccination can stimulate non-specific immune responses and reduce the incidence of certain diseases. At the beginning of the coronavirus disease 2019 (COVID-19) pandemic, it was hypothesised that the incidence of COVID-19 was lower in countries with BCG prevention. In an attempt to verify this thesis, we conducted a multicenter, randomised, double-blind, placebo-controlled study on a group of 695 health care workers aged 25 years and over in Poland. All participants in the study had a tuberculin test, after which those who were negative were randomised (1:1) and received either the BCG- or placebo vaccine. From then on, these people were subjected to three months of observation for the occurrence of COVID-19 symptoms. The statistical analysis did not reveal any significant correlation between the frequency of incidents suspected of COVID-19 and BCG-10 vaccination, the result of the tuberculin test and the number of scars. The only statistically significant feature was the type of medical profession-nurses became infected more often than doctors or other medical workers ( p  = 0.02). The results differ from similar trials in other countries. Perhaps this is due to the lack of an unvaccinated control group. The impact of BCG vaccination on the course of COVID-19 requires further research.",2022,The only statistically significant feature was the type of medical profession-nurses became infected more often than doctors or other medical workers ( p  = 0.02).,"['695 health care workers aged 25 years and over in Poland', 'All participants in the study had a tuberculin test, after which those who were negative']","['placebo', 'Tuberculosis vaccines (Bacillus Calmette-Guérin, BCG', 'Placebo', 'BCG- or placebo vaccine', 'BCG Re-Vaccination']",[],"[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041305', 'cui_str': 'Tuberculosis vaccine'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],,0.603524,The only statistically significant feature was the type of medical profession-nurses became infected more often than doctors or other medical workers ( p  = 0.02).,"[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Czajka', 'Affiliation': 'College of Medical Sciences, University of Rzeszów, 35-315 Rzeszów, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Zapolnik', 'Affiliation': 'College of Medical Sciences, University of Rzeszów, 35-315 Rzeszów, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Krzych', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Faculty of Medical Sciences, Medical University of Silesia, 40-055 Katowice, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Kmiecik', 'Affiliation': ""St. Louis Provincial Specialist Children's Hospital, 31-503 Kraków, Poland.""}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Stopyra', 'Affiliation': 'Department of Infectious Diseases and Paediatrics, Stefan Żeromski Specialist Hospital, 31-913 Kraków, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nowakowska', 'Affiliation': 'Medical Diagnostics Laboratory, Regional Sanitary-Epidemiological Station, College of Medical Sciences, University of Rzeszów, 35-315 Rzeszów, Poland.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Jackowska', 'Affiliation': 'Blessed Jerzy Popiełuszko Bielany Hospital, 01-809 Warsaw, Poland.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Darmochwał-Kolarz', 'Affiliation': 'Department of Gynaecology and Obstetrics, St. Queen Jadwiga Regional Teaching Hospital No. 2, College of Medical Sciences, University of Rzeszów, 35-315 Rzeszów, Poland.'}, {'ForeName': 'Henryk', 'Initials': 'H', 'LastName': 'Szymański', 'Affiliation': 'Saint Hedwig of Silesia Hospital, 55-100 Trzebnica, Poland.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Radziewicz-Winnicki', 'Affiliation': 'Transfiguration of the Lord Praga Hospital, 03-401 Warsaw, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Mazur', 'Affiliation': 'College of Medical Sciences, University of Rzeszów, 35-315 Rzeszów, Poland.'}]",Vaccines,['10.3390/vaccines10020314']
2458,35215057,Effect of  Lactobacillus reuteri  on Gingival Inflammation and Composition of the Oral Microbiota in Patients Undergoing Treatment with Fixed Orthodontic Appliances: Study Protocol of a Randomized Control Trial.,"The effect of probiotics in improving or maintaining oral health in orthodontic patients is understudied. The aim of this study is to evaluate the effect of probiotic administration in addition to tooth brushing on clinical gingival inflammation, plaque formation, subgingival microbiota composition, and salivary biomarkers of inflammation in adolescents with fixed orthodontic appliances. The present study is a 6-month, double-blind, two-arm, placebo-controlled, single-center trial, in which 116 adolescent volunteers aged 12-16 years will be recruited from the patients of the orthodontics clinic of the University Hospital of Lille, France. Subjects who meet the eligibility criteria will be allocated to one of the following groups: (i) control: two placebo lozenges per day for 90 days together with regular oral hygiene, (ii) test: two probiotic lozenges per day for 90 days together with regular oral hygiene. Clinical assessment and biological sample collection will be performed at baseline, 3 and 6 months. In addition, compliance outcomes and adverse events will be monitored.",2022,"Subjects who meet the eligibility criteria will be allocated to one of the following groups: (i) control: two placebo lozenges per day for 90 days together with regular oral hygiene, (ii) test: two probiotic lozenges per day for 90 days together with regular oral hygiene.","['orthodontic patients', 'Patients Undergoing Treatment with Fixed Orthodontic Appliances', '116 adolescent volunteers aged 12-16 years will be recruited from the patients of the orthodontics clinic of the University Hospital of Lille, France', 'Subjects who meet the eligibility criteria', 'adolescents with fixed orthodontic appliances']","['placebo lozenges', 'probiotic lozenges', 'placebo', 'Lactobacillus reuteri']","['Gingival Inflammation and Composition of the Oral Microbiota', 'clinical gingival inflammation, plaque formation, subgingival microbiota composition, and salivary biomarkers of inflammation']","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}]","[{'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",116.0,0.30466,"Subjects who meet the eligibility criteria will be allocated to one of the following groups: (i) control: two placebo lozenges per day for 90 days together with regular oral hygiene, (ii) test: two probiotic lozenges per day for 90 days together with regular oral hygiene.","[{'ForeName': 'Kevimy', 'Initials': 'K', 'LastName': 'Agossa', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1008-Controlled Drug Delivery Systems and Biomaterials, F-59000 Lille, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Dubar', 'Affiliation': 'Department of Periodontology, School of Dentistry, University of Lille, Place de Verdun, F-59000 Lille, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Lemaire', 'Affiliation': 'Department of Periodontology, School of Dentistry, University of Lille, Place de Verdun, F-59000 Lille, France.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Blaizot', 'Affiliation': 'Department of Dental Public Health, School of Dentistry, CHU Lille, Univ. Lille, F-59000 Lille, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Catteau', 'Affiliation': 'Department of Dental Public Health, School of Dentistry, CHU Lille, Univ. Lille, F-59000 Lille, France.'}, {'ForeName': 'Emmanuël', 'Initials': 'E', 'LastName': 'Bocquet', 'Affiliation': 'Department of Orthodontics, School of Dentistry, CHU Lille, Univ. Lille, F-59037 Lille, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Nawrocki', 'Affiliation': 'Department of Oral Surgery, School of Dentistry, CHU Lille, Univ. Lille, F-59037 Lille, France.'}, {'ForeName': 'Emile', 'Initials': 'E', 'LastName': 'Boyer', 'Affiliation': 'INSERM, INRAE, Université de Rennes 1, CHU de Rennes, Nutrition Metabolisms and Cancer, F-35000 Rennes, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Meuric', 'Affiliation': 'INSERM, INRAE, Université de Rennes 1, CHU de Rennes, Nutrition Metabolisms and Cancer, F-35000 Rennes, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Siepmann', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1008-Controlled Drug Delivery Systems and Biomaterials, F-59000 Lille, France.'}]","Pathogens (Basel, Switzerland)",['10.3390/pathogens11020112']
2459,35215507,"Maternal Hemoglobin Concentrations and Birth Weight, Low Birth Weight (LBW), and Small for Gestational Age (SGA): Findings from a Prospective Study in Northwest China.","Birth weight and related outcomes have profound influences on life cycle health, but the effect of maternal hemoglobin concentration during pregnancy on birth weight is still unclear. This study aims to reveal the associations between maternal hemoglobin concentrations in different trimesters of pregnancy and neonatal birth weight, LBW, and SGA. This was a prospective study based on a cluster-randomized controlled trial conducted from July 2015 to December 2019 in rural areas of Northwest China. Information on maternal socio-demographic status, health-related factors, antenatal visits, and neonatal birth outcomes were collected. A total of 3748 women and their babies were included in the final analysis. A total of 65.1% and 46.3% of the participants had anemia or hemoglobin ≥ 130 g/L during pregnancy. In the third trimester, maternal hemoglobin concentration was associated with birth weight in an inverted U-shaped curve and with the risks of LBW and SGA in extended U-shaped curves. The relatively higher birth weight and lower risks for LBW and SGA were observed when hemoglobin concentration was 100-110 g/L. When maternal hemoglobin was <70 g/L or >130 g/L, the neonatal birth weight was more than 100 g lower than that when the maternal hemoglobin was 100 g/L. In conclusion, both low and high hemoglobin concentrations in the third trimester could be adverse to fetal weight growth and increase the risks of LBW and SGA, respectively. In addition to severe anemia, maternal hemoglobin >130 g/L in the third trimester should be paid great attention to in the practice of maternal and child health care.",2022,The relatively higher birth weight and lower risks for LBW and SGA were observed when hemoglobin concentration was 100-110 g/L.,"['3748 women and their babies', 'July 2015 to December 2019 in rural areas of Northwest China']",['SGA'],"['birth weight', 'maternal socio-demographic status, health-related factors, antenatal visits, and neonatal birth outcomes', 'maternal hemoglobin concentration', 'hemoglobin concentration', 'maternal hemoglobin concentrations', 'neonatal birth weight', 'Maternal Hemoglobin Concentrations and Birth Weight, Low Birth Weight (LBW), and Small for Gestational Age', 'birth weight and lower risks for LBW and SGA']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}]",[],"[{'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]",3748.0,0.147259,The relatively higher birth weight and lower risks for LBW and SGA were observed when hemoglobin concentration was 100-110 g/L.,"[{'ForeName': 'Danmeng', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ""Department of Epidemiology and Health Statistics, School of Public Health, Health Science Center, Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'School of Public Health, Shandong First Medical University & Shandong Academy of Medical Sciences, Taian 271016, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Epidemiology and Health Statistics, School of Public Health, Health Science Center, Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Yijun', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': ""Department of Epidemiology and Health Statistics, School of Public Health, Health Science Center, Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Department of Nutrition, School of Public Health, Health Science Center, Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Lingxia', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': ""Department of Epidemiology and Health Statistics, School of Public Health, Health Science Center, Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Fangyao', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ""Department of Epidemiology and Health Statistics, School of Public Health, Health Science Center, Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Baibing', 'Initials': 'B', 'LastName': 'Mi', 'Affiliation': ""Department of Epidemiology and Health Statistics, School of Public Health, Health Science Center, Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Qu', 'Affiliation': ""Translational Medicine Center, Northwest Women's and Children's Hospital, Xi'an 710061, China.""}, {'ForeName': 'Doudou', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': ""Translational Medicine Center, Northwest Women's and Children's Hospital, Xi'an 710061, China.""}, {'ForeName': 'Zhonghai', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ""Department of Epidemiology and Health Statistics, School of Public Health, Health Science Center, Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Department of Epidemiology and Health Statistics, School of Public Health, Health Science Center, Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool L3 5QA, UK.'}, {'ForeName': 'Shaonong', 'Initials': 'S', 'LastName': 'Dang', 'Affiliation': ""Department of Epidemiology and Health Statistics, School of Public Health, Health Science Center, Xi'an Jiaotong University, Xi'an 710061, China.""}]",Nutrients,['10.3390/nu14040858']
2460,35215501,"Use of Nutritional Supplements Based on L-Theanine and Vitamin B6 in Children with Tourette Syndrome, with Anxiety Disorders: A Pilot Study.","BACKGROUND


Tourette syndrome (TS) is a neurodevelopmental disorder characterized by tics and co-occurring disorders. It has been suggested that anxiety occurs in 2-45% patients affected by Tourette syndrome. Despite dietary and nutritional factors have been found to affect a range of neurological conditions, no more studies have investigated the relationship between nutritional supplements and tics.
OBJECTIVE


To evaluate the effectiveness of supplementation of both L-Theanine and Vitamin B6 in reducing tics and co-occurring disorders in a sample of youth with chronic tic disorder (CTD) or Tourette syndrome with anxiety symptoms.
DESIGN


A open-label trial. Patients affected by Tourette syndrome were randomized to receive nutritional supplements based on L-Theanine and vitamin B6, or psychoeducation (PE).
PARTICIPANTS


34 children (30 boys and 4 girls) aged between 4 and 17 years affected by Tourette syndrome or chronic tic disorder, associated with anxiety symptoms.
RESULTS


Patients in both groups showed a reduction in the severity of tic and anxiety symptoms. Supplementation with L-Theanine and vitamin B6 was significantly more effective than psychoeducation in reducing tics and co-occurring disorders, as measured by neuropsychological findings.
CONCLUSIONS


Supplementation of both L-Theanine and Vitamin B6 may help in the treatment of tic disorders associated with anxious symptoms. Between-group differences in clinician-rated severity did reach statistical significance only for tics. Despite this finding, further placebo-controlled trials are needed.",2022,"Supplementation with L-Theanine and vitamin B6 was significantly more effective than psychoeducation in reducing tics and co-occurring disorders, as measured by neuropsychological findings.
","['Children with Tourette Syndrome, with Anxiety Disorders', '34 children (30 boys and 4 girls) aged between 4 and 17 years affected by Tourette syndrome or chronic tic disorder, associated with anxiety symptoms', 'Patients affected by Tourette syndrome', 'youth with chronic tic disorder (CTD) or Tourette syndrome with anxiety symptoms']","['nutritional supplements based on L-Theanine and vitamin B6, or psychoeducation (PE', 'placebo', 'L-Theanine and Vitamin B6', 'Nutritional Supplements Based on L-Theanine and Vitamin B6', 'L-Theanine and vitamin B6']",['severity of tic and anxiety symptoms'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040517', 'cui_str': ""Gilles de la Tourette's syndrome""}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0008701', 'cui_str': 'Chronic tic disorder'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0076380', 'cui_str': 'theanine'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",34.0,0.100407,"Supplementation with L-Theanine and vitamin B6 was significantly more effective than psychoeducation in reducing tics and co-occurring disorders, as measured by neuropsychological findings.
","[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Rizzo', 'Affiliation': 'Child and Adolescent Neurology and Psychiatric Section, Department of Clinical and Experimental Medicine, Catania University, 95124 Catania, Italy.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Prato', 'Affiliation': 'Child and Adolescent Neurology and Psychiatric Section, Department of Clinical and Experimental Medicine, Catania University, 95124 Catania, Italy.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Scerbo', 'Affiliation': 'Child and Adolescent Neurology and Psychiatric Section, Department of Clinical and Experimental Medicine, Catania University, 95124 Catania, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Saia', 'Affiliation': 'Child and Adolescent Neurology and Psychiatric Section, Department of Clinical and Experimental Medicine, Catania University, 95124 Catania, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Barone', 'Affiliation': 'Child and Adolescent Neurology and Psychiatric Section, Department of Clinical and Experimental Medicine, Catania University, 95124 Catania, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Curatolo', 'Affiliation': 'Child Neurology and Psychiatry Unit, Systems Medicine Department, University of Rome Tor Vergata, 00133 Rome, Italy.'}]",Nutrients,['10.3390/nu14040852']
2461,35218626,[Effect of acupuncture at Huatuo Jiaji (EX-B2) combined with core muscle training on motor function of lower limbs in patients with hemiplegia after stroke].,"OBJECTIVE


To observe the effect of acupuncture at Huatuo Jiaji (EX-B2) combined with core muscle training on motor function of lower limbs, balance function and core muscle in patients with hemiplegia after stroke.
METHODS


A total of ninety-six patients with hemiplegia after stroke were randomly and equally divided into acupuncture, training and combination groups ( n =32 cases in each). Patients of the acupuncture group were given acupuncture at the 5 th , 7 th , 9 th  and 11 th  chest vertebrae, and the 1 st  to 5 th  lumbar vertebrae of EX-B2. Patients in the training group received core muscle training. In the combination group, both acupuncture treatment and core muscle training were given to the patients. The treatment was conducted once daily, 5 times a week for 4 weeks. The Fugl-Meyer lower limb motor function score (FMA), Berg balance function scale (BBS), Barthel index (BI) and surface electromyography (sEMG) of the erector spinae and rectus abdominis were evaluated before and after treatment and during the follow-up period.
RESULTS


Compared with the scores before the treatment, the FMA, BBS and BI scores were obviously increased after the treatment and during the follow-up period in the three groups respectively ( P <0.05). After treatment and during the follow-up period, the root mean square (RMS) of erector spinae and rectus abdominis in the sitting position flexed 45° and extended 30° on the healthy and affected side were higher than those of the same side before treatment in the three groups ( P <0.05). The therapeutic effect of combination of acupuncture at EX-B2 and core muscle training was obviously superior to that of single acupuncture or single training ( P <0.05). Before the treatment, the RMS of erector spinae and rectus abdominis in the sitting position flexed 45° and extended 30° on the affected side were lower than those of the healthy side in the three groups ( P <0.05), while there was no significant difference between the RMS of the erector spinae and rectus abdominis of the affected side and the healthy side in the comprehensive group after treatment and during the follow-up period (P＞0.05).
CONCLUSION


Acupuncture at EX-B2 combined with core muscle training can significantly improve the balance function and lower limb motor function of patients with hemiplegia after stroke.",2022,"Compared with the scores before the treatment, the FMA, BBS and BI scores were obviously increased after the treatment and during the follow-up period in the three groups respectively ( P <0.05).","['patients with hemiplegia after stroke', 'A total of ninety-six patients with hemiplegia after stroke']","['acupuncture', 'core muscle training', 'Acupuncture at EX-B2 combined with core muscle training', 'acupuncture at Huatuo Jiaji (EX-B2) combined with core muscle training', 'acupuncture, training and combination groups', 'acupuncture treatment and core muscle training']","['RMS of the erector spinae and rectus abdominis of the affected side and the healthy side', 'root mean square (RMS) of erector spinae and rectus abdominis in the sitting position flexed 45° and extended 30° on the healthy and affected side', 'Fugl-Meyer lower limb motor function score (FMA), Berg balance function scale (BBS), Barthel index (BI) and surface electromyography (sEMG) of the erector spinae and rectus abdominis', 'FMA, BBS and BI scores', 'RMS of erector spinae and rectus abdominis in the sitting position flexed 45° and extended 30° on the affected side', 'motor function of lower limbs, balance function and core muscle', 'motor function of lower limbs', 'balance function and lower limb motor function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319625', 'cui_str': '96'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",96.0,0.0119425,"Compared with the scores before the treatment, the FMA, BBS and BI scores were obviously increased after the treatment and during the follow-up period in the three groups respectively ( P <0.05).","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, Anhui Province, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, Anhui Province, China.'}, {'ForeName': 'Jun-Tao', 'Initials': 'JT', 'LastName': 'Du', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, Anhui Province, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, Anhui Province, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, Anhui Province, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'The Second Department of Rehabilitation, The Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230061.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.20210487']
2462,35218604,Evaluation of the pharmacokinetics of trazpiroben (TAK-906) in the presence and absence of the proton pump inhibitor esomeprazole.,"Trazpiroben, a dopamine D 2  /D 3  receptor antagonist under development to treat gastroparesis, displays decreasing solubility with increasing pH. This single-sequence, open-label, two-period, crossover study evaluated the effect of esomeprazole, a proton pump inhibitor that raises gastric pH, on the single-dose pharmacokinetics, safety, and tolerability of trazpiroben in healthy adults (NCT03849690). In total, 12 participants were enrolled and entered period 1 (days 1-3), receiving a single oral dose of trazpiroben 25 mg on day 1. After a 4-day washout, participants then entered period 2 (days 8-13) and received esomeprazole 40 mg once daily on days 8-12, with a single oral dose of trazpiroben 25 mg co-administered 1 h post esomeprazole dosing on day 11. Geometric mean area under the curve from time 0 extrapolated to infinity (AUC ∞  ) and maximum plasma concentration (C max  ) values were generally similar when trazpiroben was administered alone versus alongside esomeprazole (AUC ∞  , 44.03 vs. 38.85 ng h/ml; C max  , 19.76 vs. 17.24 ng/ml). Additionally, the associated geometric mean ratio (GMR; co-administration: administration alone) 90% confidence intervals (CIs) suggested no clinically meaningful difference between treatment groups (AUC ∞  , GMR 0.88, 90% CI 0.78-1.00; C max  , 0.87, 90% CI 0.70-1.09). Mean apparent first-order terminal elimination half-life values were similar between treatments, illustrating co-administration with esomeprazole had minimal effect on trazpiroben elimination. Trazpiroben was well-tolerated in healthy adults following administration alone and alongside esomeprazole, with no clinically relevant adverse events reported. The lack of evidence of any clinically meaningful drug-drug interaction supports the co-administration of esomeprazole with trazpiroben.",2022,"Mean apparent first-order terminal elimination half-life values were similar between treatments, illustrating co-administration with esomeprazole had minimal effect on trazpiroben elimination.","['12 participants were enrolled and entered period 1 (days 1-3), receiving a single oral dose of', 'healthy adults (NCT03849690', 'healthy adults']","['esomeprazole with trazpiroben', 'trazpiroben 25\xa0mg on day 1', 'Trazpiroben', 'trazpiroben 25\xa0mg co-administered 1\xa0h post esomeprazole', 'trazpiroben (TAK-906', 'esomeprazole', 'trazpiroben', 'Trazpiroben, a dopamine D 2  /D']","['trazpiroben elimination', 'tolerated', 'Geometric mean area under the curve from time 0 extrapolated to infinity (AUC ∞  ) and maximum plasma concentration (C max  ) values', 'Mean apparent first-order terminal elimination half-life values']","[{'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",12.0,0.0834904,"Mean apparent first-order terminal elimination half-life values were similar between treatments, illustrating co-administration with esomeprazole had minimal effect on trazpiroben elimination.","[{'ForeName': 'Jatinder Kaur', 'Initials': 'JK', 'LastName': 'Mukker', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dukes', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Lisi', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Huh', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Polyna', 'Initials': 'P', 'LastName': 'Khudyakov', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Nishihara', 'Affiliation': 'Takeda Pharmaceutical Company, Ltd., Fujisawa, Kanagawa, Japan.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.'}]",Clinical and translational science,['10.1111/cts.13248']
2463,34710038,Development of a physiological-based model that uses standard polysomnography and clinical data to predict oral appliance treatment outcomes in obstructive sleep apnea.,"STUDY OBJECTIVES


Oral appliance (OA) therapy is a well-tolerated alternative to continuous positive airway pressure. However, it is less efficacious. A major unresolved clinical challenge is the inability to accurately predict who will respond to OA therapy. We recently developed a model to estimate obstructive sleep apnea pathophysiological endotypes. This study aimed to apply this physiological-based model to predict OA treatment responses.
METHODS


Sixty-two men and women with obstructive sleep apnea (aged 29-71 years) were studied to investigate the efficacy of a novel OA device. An in-laboratory diagnostic followed by an OA treatment efficacy polysomnography were performed. Seven polysomnography variables from the diagnostic study plus age and body mass index were included in our machine-learning-based model to predict OA therapy response according to standard apnea-hypopnea index (AHI) definitions. Initially, the model was trained on data from the first 45 participants using 10-fold cross-validation. A blinded independent validation was then performed for the remaining 17 participants.
RESULTS


Mean accuracy of the trained model to predict OA therapy responders vs nonresponders (AHI < 5 events/h) using 10-fold cross-validation was 91% ± 8%. In the independent blinded validation, 100% (AHI < 5 events/h); 59% (AHI < 10 events/h); 71% (50% reduction in AHI); and 82% (50% reduction in AHI to < 20 events/h) of the 17 participants were correctly classified for each of the treatment outcome definitions respectively.
CONCLUSIONS


While further evaluation in larger clinical data sets is required, these findings highlight the potential to use routinely collected sleep study and clinical data with machine learning-based approaches underpinned by obstructive sleep apnea endotype concepts to help predict treatment outcomes to OA therapy for people with obstructive sleep apnea.
CITATION


Dutta R, Tong BK, Eckert DJ. Development of a physiological-based model that uses standard polysomnography and clinical data to predict oral appliance treatment outcomes in obstructive sleep apnea.  J Clin Sleep Med . 2022;18(3):861-870.",2022,Mean accuracy of the trained model to predict OA therapy responders vs nonresponders (AHI < 5 events/h) using 10-fold cross-validation was 91% ± 8%.,"['people with obstructive sleep apnea', 'remaining 17 participants', 'obstructive sleep apnea', 'Sixty-two men and women with obstructive sleep apnea (aged 29-71 years', 'Oral appliance (OA']",['OA therapy'],['Mean accuracy'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",17.0,0.0399146,Mean accuracy of the trained model to predict OA therapy responders vs nonresponders (AHI < 5 events/h) using 10-fold cross-validation was 91% ± 8%.,"[{'ForeName': 'Ritaban', 'Initials': 'R', 'LastName': 'Dutta', 'Affiliation': 'Data61, Commonwealth Scientific and Industrial Research Organisation, Hobart, Tasmania, Australia.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Tong', 'Affiliation': 'Neuroscience Research Australia, Randwick Sydney, New South Wales, Australia.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Eckert', 'Affiliation': 'Neuroscience Research Australia, Randwick Sydney, New South Wales, Australia.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9742']
2464,34666011,Lung Response to a Higher Positive End-Expiratory Pressure in Mechanically Ventilated Patients With COVID-19.,"BACKGROUND


International guidelines suggest using a higher (> 10 cm H 2 O) positive end-expiratory pressure (PEEP) in patients with moderate-to-severe ARDS due to COVID-19. However, even if oxygenation generally improves with a higher PEEP, compliance, and Paco 2  frequently do not, as if recruitment was small.
RESEARCH QUESTION


Is the potential for lung recruitment small in patients with early ARDS due to COVID-19?
STUDY DESIGN AND METHODS


Forty patients with ARDS due to COVID-19 were studied in the supine position within 3 days of endotracheal intubation. They all underwent a PEEP trial, in which oxygenation, compliance, and Paco 2  were measured with 5, 10, and 15 cm H 2 O of PEEP, and all other ventilatory settings unchanged. Twenty underwent a whole-lung static CT scan at 5 and 45 cm H 2 O, and the other 20 at 5 and 15 cm H 2 O of airway pressure. Recruitment and hyperinflation were defined as a decrease in the volume of the non-aerated (density above -100 HU) and an increase in the volume of the over-aerated (density below -900 HU) lung compartments, respectively.
RESULTS


From 5 to 15 cm H 2 O, oxygenation improved in 36 (90%) patients but compliance only in 11 (28%) and Paco 2  only in 14 (35%). From 5 to 45 cm H 2 O, recruitment was 351 (161-462) mL and hyperinflation 465 (220-681) mL. From 5 to 15 cm H 2 O, recruitment was 168 (110-202) mL and hyperinflation 121 (63-270) mL. Hyperinflation variably developed in all patients and exceeded recruitment in more than half of them.
INTERPRETATION


Patients with early ARDS due to COVID-19, ventilated in the supine position, present with a large potential for lung recruitment. Even so, their compliance and Paco 2  do not generally improve with a higher PEEP, possibly because of hyperinflation.",2021,"From 5 to 15 cm H 2 O, oxygenation improved in 36 (90%) patients but compliance only in 11 (28%) and Paco 2  only in 14 (35%).","['Forty patients with ARDS due to COVID-19', 'patients with moderate-to-severe ARDS due to COVID-19', 'Mechanically Ventilated Patients With COVID-19']","['whole-lung static CT scan at 5 and 45\xa0cm', 'mL and hyperinflation 465', 'endotracheal intubation']",['Recruitment and hyperinflation'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}]",40.0,0.120422,"From 5 to 15 cm H 2 O, oxygenation improved in 36 (90%) patients but compliance only in 11 (28%) and Paco 2  only in 14 (35%).","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Protti', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Department of Anesthesia and Intensive Care Units, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy. Electronic address: alessandro.protti@hunimed.eu.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Santini', 'Affiliation': 'Department of Anesthesia and Intensive Care Units, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pennati', 'Affiliation': 'Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Chiurazzi', 'Affiliation': 'Department of Anesthesia and Intensive Care Units, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Cressoni', 'Affiliation': 'Unit of Radiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ferrari', 'Affiliation': 'Department of Anesthesia and Intensive Care Units, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Giacomo E', 'Initials': 'GE', 'LastName': 'Iapichino', 'Affiliation': 'Department of Anesthesia and Intensive Care Units, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Carenzo', 'Affiliation': 'Department of Anesthesia and Intensive Care Units, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Ezio', 'Initials': 'E', 'LastName': 'Lanza', 'Affiliation': 'Department of Radiology, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Picardo', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Caironi', 'Affiliation': 'Department of Oncology, University of Turin, Turin, Italy; Department of Anesthesia and Critical Care, Azienda Ospedaliero-Universitaria S. Luigi Gonzaga, Orbassano, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Aliverti', 'Affiliation': 'Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Cecconi', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Department of Anesthesia and Intensive Care Units, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.'}]",Chest,['10.1016/j.chest.2021.10.012']
2465,34881670,Effectiveness of additional resistance and balance training and telephone support program in exercise-based cardiac rehabilitation on quality of life and physical activity: Randomized control trial.,"OBJECTIVES


To evaluate 20 days and 3 months follow-up effectiveness of cardiac rehabilitation (CR) enhanced by resistance/balance training and telephone-support program compared to usual CR care in improving quality of life, clinical course and physical activity behavior.
DESIGN


Single-centre randomized controlled trial.
SETTING


Inpatient CR clinic.
SUBJECTS


116 (76.1 ± 6.7 years, 50% male) patients 14.5 ± 5.9 days after valve surgery/intervention were randomized to intervention group (IG,  n  = 60) or control group (CG,  n  = 56).
INTERVENTION


Additional resistance/balance training (3 days/week) during phase-II CR and telephone-support program during 3-month follow-up. CG patients were provided with usual CR care.
MAIN MEASURES


Short Form 36 Health Survey scales, European Quality of Life 5 Dimensions 3 Level Version QoL index, visual analog scale, clinical course, and physical activity behavior assessed with standardized questionnaires.
RESULTS


IG reported statistically significant higher mental component score (48.5 ± 6.91 vs. 40.3 ± 11.21 at the baseline, 50.8 ± 9.76 vs. 42.6 ± 9.82 after 20 days, 49.4 ± 8.45 vs. 40.5 ± 8.9 after 12 weeks follow up), general health (48.6 ± 3.17 vs. 45.0 ± 2.95 at the baseline, 53.6 ± 3.02 vs. 43.8 ± 2.55 after 20 days, 53.2 ± 3.11 vs. 44.2 ± 3.07 after 12 weeks) and role limitations due to emotional problems (48.5 ± 15.2 vs. 27.7 ± 11.5 at the baseline, 72.7 ± 12.6 vs. 30.5 ± 11.2 after 20 days, 66.6 ± 14.2 vs. 36.1 ± 11.2 after 12 weeks) in all three assessments ( p  < 0.05). CG patients had more documented hospital admissions (4 (8%) vs 10 (25%),  p  = 0.027), atrial fibrillation paroxysms (3 (6.0%) vs. 10 (35.0%),  p  = 0.011) and blood pressure swings (13 (26%) vs. 20 (50%),  p  = 0.019). IG patients chose more different physical activities (1.7 ± 0.7 vs. 1.25 ± 0.63,  p  = 0.002), spent more time being physical active every day (195.6 ± 78.6 vs. 157.29 ± 78.8,  p  = 0.002).
CONCLUSIONS


The addition of resistance/balance exercises and telephone-support program 12 weeks after to the CR could linked to higher physical activity levels and fewer clinical complications but did not lead to a significant improvement in quality of life.",2022,"CG patients had more documented hospital admissions (4 (8%) vs 10 (25%),  p  = 0.027), atrial fibrillation paroxysms (3 (6.0%) vs. 10 (35.0%),  p  = 0.011) and blood pressure swings (13 (26%) vs. 20 (50%),  p  = 0.019).","['Inpatient CR clinic', '116 (76.1\u2009±\u20096.7 years, 50% male) patients 14.5\u2009±\u20095.9 days after valve surgery/intervention']","['Additional resistance/balance training', 'additional resistance and balance training and telephone support program', 'intervention group (IG,  n \u2009=\u200960) or control group (CG,  n \u2009=\u200956', 'cardiac rehabilitation (CR) enhanced by resistance/balance training and telephone-support program compared to usual CR care']","['quality of life and physical activity', 'physical activity levels', 'hospital admissions', 'atrial fibrillation paroxysms', 'general health', 'physical activities', 'mental component score', 'quality of life', 'blood pressure swings', 'Short Form 36 Health Survey scales, European Quality of Life 5 Dimensions 3 Level Version QoL index, visual analog scale, clinical course, and physical activity behavior assessed with standardized questionnaires', 'quality of life, clinical course and physical activity behavior']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449259', 'cui_str': 'Clinical course'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0204214,"CG patients had more documented hospital admissions (4 (8%) vs 10 (25%),  p  = 0.027), atrial fibrillation paroxysms (3 (6.0%) vs. 10 (35.0%),  p  = 0.011) and blood pressure swings (13 (26%) vs. 20 (50%),  p  = 0.019).","[{'ForeName': 'Egle', 'Initials': 'E', 'LastName': 'Tamulevičiūtė-Prascienė', 'Affiliation': 'Rehabilitation department, 230647Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Aurelija', 'Initials': 'A', 'LastName': 'Beigienė', 'Affiliation': 'Rehabilitation department, 230647Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Urtė', 'Initials': 'U', 'LastName': 'Lukauskaitė', 'Affiliation': 'Faculty of medicine, 230647Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Kamilė', 'Initials': 'K', 'LastName': 'Gerulytė', 'Affiliation': 'Faculty of medicine, 230647Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Raimondas', 'Initials': 'R', 'LastName': 'Kubilius', 'Affiliation': 'Rehabilitation department, 230647Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Birna', 'Initials': 'B', 'LastName': 'Bjarnason-Wehrens', 'Affiliation': 'Department of Preventive and Rehabilitative Sport and Exercise Medicine, Institute of Cardiology and Sports Medicine, 14926German Sport University Cologne, Cologne, Germany.'}]",Clinical rehabilitation,['10.1177/02692155211065632']
2466,34881669,"Maximising Abilities, Negotiating and Generating Exercise options (MANAGE) in people with multiple sclerosis: A feasibility randomised controlled trial.","OBJECTIVE


To investigate the feasibility and preliminary efficacy of a group self-management exercise and education program in people with multiple sclerosis.
DESIGN


Feasibility randomised controlled trial.
SETTING


Outpatient rehabilitation facility.
SUBJECTS


Twenty-three adults (age 48.6 (11.7) years) recruited from a Multiple Sclerosis Clinic register.
INTERVENTIONS


The intervention group undertook a 12-week group program incorporating behaviour change education, exercise and community integration. This was compared with a waitlist control group.
MAIN MEASURES


Feasibility was measured by recruitment, adherence and safety. Efficacy outcomes included measures of physical function (6-metre and 6-min walk, Functional Reach) and self-report questionnaires (fatigue, quality of life, exercise benefits and barriers) at baseline, 6, 12 and 24 weeks.
RESULTS


Of 74 individuals identified through the register, 48 (65%) were contacted and deemed eligible, and 23 (48%) agreed to participate. There was high adherence for attendance at education (57 of 72, 79%) and exercise (135 of 174, 78%) sessions. No adverse safety events occurred within the intervention sessions. Missed attendances at assessment sessions was high (5 to 8 participants missed at each time point) predominately due to health issues. The intervention group demonstrated positive changes in walking endurance, Functional Reach and fatigue, whereas the control had some reductions in walking speed and more perceived exercise barriers.
CONCLUSIONS


The MANAGE program appears feasible and safe for people with mild-to-moderate multiple sclerosis, with high adherence to exercise and education sessions. Future trials should consider strategies such as flexible scheduling or alternative methods of data collection to improve follow-up assessment attendance.",2022,"The intervention group demonstrated positive changes in walking endurance, Functional Reach and fatigue, whereas the control had some reductions in walking speed and more perceived exercise barriers.
","['people with mild-to-moderate multiple sclerosis', 'people with multiple sclerosis', 'Of 74 individuals identified through the register, 48 (65%) were contacted and deemed eligible, and 23 (48%) agreed to participate', 'Twenty-three adults (age 48.6 (11.7) years) recruited from a Multiple Sclerosis Clinic register', 'Outpatient rehabilitation facility']","['Maximising Abilities, Negotiating and Generating Exercise options', 'group self-management exercise and education program', '12-week group program incorporating behaviour change education, exercise and community integration']","['walking speed and more perceived exercise barriers', 'positive changes in walking endurance, Functional Reach and fatigue', 'adverse safety events', 'adherence and safety', 'physical function (6-metre and 6-min walk, Functional Reach) and self-report questionnaires (fatigue, quality of life, exercise benefits and barriers']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3839267', 'cui_str': 'Multiple sclerosis clinic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3845566', 'cui_str': 'Rehabilitation facility'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3494302', 'cui_str': 'Community Integration'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0456965', 'cui_str': '20 feet'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",23.0,0.0128476,"The intervention group demonstrated positive changes in walking endurance, Functional Reach and fatigue, whereas the control had some reductions in walking speed and more perceived exercise barriers.
","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Louie', 'Affiliation': 'Department of Physiotherapy, 90134Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Baquie', 'Affiliation': 'Department of Physiotherapy, 90134Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Offerman', 'Affiliation': 'Department of Physiotherapy, 90134Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Granger', 'Affiliation': 'Department of Physiotherapy, 90134Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Fary', 'Initials': 'F', 'LastName': 'Khan', 'Affiliation': 'Department of Physiotherapy, 90134Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Bower', 'Affiliation': 'Department of Physiotherapy, 90134Royal Melbourne Hospital, Melbourne, VIC, Australia.'}]",Clinical rehabilitation,['10.1177/02692155211064949']
2467,34856379,Lung ultrasound-guided dry-weight reduction and echocardiographic changes in clinically euvolemic hypertensive hemodialysis patients: 12-month results of a randomized controlled trial.,"OBJECTIVE


Left ventricular hypertrophy (LVH) and dysfunction are highly prevalent in hemodialysis patients and are independently associated with adverse outcomes. This study examines the long-term effects of dry-weight reduction with a standardized lung ultrasound (LUS)-guided strategy on echocardiographic indexes of left ventricular (LV) mass and function in hemodialysis patients.
METHODS


Seventy-one clinically euvolemic hemodialysis patients with hypertension were randomized to dry-weight reduction guided by pre-hemodialysis LUS (n = 35) or standard-of-care treatment (n = 36) and were followed-up for 12 months. Two-dimensional and tissue-Doppler echocardiographies (TDI) were performed at the baseline and 12-month evaluations.
RESULTS


During follow-up, dry-weight reduction took place in more patients in the active arm than in the control arm of the trial (71.4% vs 22.2%; p < 0.001). Left atrial (LA) surface (-1.37 ± 4.50 vs 1.28 ± 5.00 cm 2 ; P = 0.006) and LA volume index (-3.22 ± 11.82 vs 4.76 ± 12.83 ml/m 2 ; P = 0.009) decreased in the active and increased in the control group. LV end-diastolic volume (-0.94 ± 11.45 vs 6.58 ± 13.92 ml/m 2 ; P = 0.015) decreased only in the active group. The LV mass index was unchanged in the active (134.21 ± 44.75 vs 133.57 ± 45.51; P = 0.844) and marginally increased in the control group (134.21 ± 40.96 vs 143.77 ± 50.04 g/m 2 ; P = 0.089). The LV E/e' wave ratio was unchanged in the active (12.45 ± 4.69 vs 12.56 ± 4.89; P = 0.521) and increased in the usual-care group (10.91 ± 4.97 vs12.36 ± 6.43; P = 0.003). LV systolic function did not differ between the two study arms across the trial.
CONCLUSION


Over 12 months, LUS-guided dry-weight reduction is associated with reverse LV and LA remodeling, myocardial hypertrophy regression, and improved LV diastolic filling properties.",2021,"During follow-up, dry-weight reduction took place in more patients in the active arm than in the control arm of the trial (71.4% vs 22.2%; p < 0.001).","['hemodialysis patients', 'clinically euvolemic hypertensive hemodialysis patients', 'Seventy-one clinically euvolemic hemodialysis patients with hypertension']","['dry-weight reduction with a standardized lung ultrasound (LUS)-guided strategy', 'Lung ultrasound-guided dry-weight reduction', 'dry-weight reduction guided by pre-hemodialysis LUS']","['reverse LV and LA remodeling, myocardial hypertrophy regression, and improved LV diastolic filling properties', 'LV mass index', 'LA volume index', 'dry-weight reduction took place', 'LV end-diastolic volume', ""LV E/e' wave ratio"", 'LV systolic function', 'Left atrial (LA) surface', 'echocardiographic indexes of left ventricular (LV) mass and function']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C2709005', 'cui_str': 'Dry body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C3658220', 'cui_str': 'Myocardial Remodeling, Atrial'}, {'cui': 'C3495916', 'cui_str': 'Myocardial hypertrophy'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",71.0,0.0540137,"During follow-up, dry-weight reduction took place in more patients in the active arm than in the control arm of the trial (71.4% vs 22.2%; p < 0.001).","[{'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Loutradis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Greece. Electronic address: loutradis_haris@hotmail.com.'}, {'ForeName': 'Christodoulos E', 'Initials': 'CE', 'LastName': 'Papadopoulos', 'Affiliation': '3rd Department of Cardiology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Sachpekidis', 'Affiliation': 'Department of Cardiology, Papageorgiou Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ekart', 'Affiliation': 'University Clinical Centre Maribor, Clinic for Internal Medicine, Department of Dialysis, Maribor, Slovenia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Krunic', 'Affiliation': 'University Clinical Centre Maribor, Clinic for Internal Medicine, Department of Cardiology, Maribor, Slovenia.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Papadopoulou', 'Affiliation': 'Department of Nephrology, Papageorgiou Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Papagianni', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Greece.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Mallamaci', 'Affiliation': 'CNR-IFC Clinical Epidemiology of Renal Diseases and Hypertension, Reggio Calabria, Italy.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Zoccali', 'Affiliation': 'CNR-IFC Clinical Epidemiology of Renal Diseases and Hypertension, Reggio Calabria, Italy.'}, {'ForeName': 'Pantelis A', 'Initials': 'PA', 'LastName': 'Sarafidis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Greece.'}]",Hellenic journal of cardiology : HJC = Hellenike kardiologike epitheorese,['10.1016/j.hjc.2021.11.002']
2468,35219973,Robot-Assisted Therapy Combined with Trunk Restraint in Acute Stroke Patients: A Randomized Controlled Study.,"BACKGROUND


Reducing the compensatory mechanism by restraining unnecessary trunk movements may help enhance the effectiveness of robot-assisted therapy.
OBJECTIVE


This study aimed to investigate the effects of robot-assisted therapy in combination with trunk restraint on upper extremity function and on daily activities in patients with acute stroke (≤ 30days of onset).
METHODS


Thirty-six acute stroke patients were randomly assigned to an experimental (n=18) or control (n=18) group. The experimental group performed robot-assisted therapy combined with trunk restraint, while the control group performed only robot-assisted therapy. Both groups were treated for 30 min, 5 days a week, for a total of 3 weeks. The outcome measures included the Fugl-Meyer assessment upper extremity, wolf motor function test, motor activity log, upper extremity muscle strength, and modified Barthel index.
RESULTS


After the intervention, both groups showed significant improvements in Fugl-Meyer assessment upper extremity, wolf motor function test, motor activity log, elbow extensor muscle strength, and modified Barthel index (p < 0.05). Post-intervention, the experimental group exhibited greater changes in the Fugl-Meyer assessment upper extremity, motor activity log, and elbow extensor muscle strength (p < 0.05).
CONCLUSION


Our study suggests that robot-assisted therapy in combination with trunk restraint is more effective for improving upper extremity function than only robot-assisted therapy in acute stroke patients.",2022,"Post-intervention, the experimental group exhibited greater changes in the Fugl-Meyer assessment upper extremity, motor activity log, and elbow extensor muscle strength (p < 0.05).
","['acute stroke patients', 'Thirty-six', 'patients with acute stroke (≤ 30days of onset', 'Acute Stroke Patients']","['Robot-Assisted Therapy Combined with Trunk Restraint', 'robot-assisted therapy combined with trunk restraint, while the control group performed only robot-assisted therapy', 'trunk restraint', 'robot-assisted therapy']","['Fugl-Meyer assessment upper extremity, wolf motor function test, motor activity log, elbow extensor muscle strength, and modified Barthel index', 'Fugl-Meyer assessment upper extremity, wolf motor function test, motor activity log, upper extremity muscle strength, and modified Barthel index', 'Fugl-Meyer assessment upper extremity, motor activity log, and elbow extensor muscle strength']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1718418', 'cui_str': 'Trunk restraint'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}]",36.0,0.0219218,"Post-intervention, the experimental group exhibited greater changes in the Fugl-Meyer assessment upper extremity, motor activity log, and elbow extensor muscle strength (p < 0.05).
","[{'ForeName': 'Min-Cheol', 'Initials': 'MC', 'LastName': 'Joo', 'Affiliation': 'Department of Rehabilitation Medicine and Institute of Wonkwang Medical Science, Wonkwang University School of Medicine and Hospital, Iksan, South Korea.'}, {'ForeName': 'Kyeoung-Man', 'Initials': 'KM', 'LastName': 'Jung', 'Affiliation': 'Department of Physical Therapy, Wonkwang University Hospital, Iksan, South Korea. Electronic address: future1347@naver.com.'}, {'ForeName': 'Ji-Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Wonkwang University Medical School and Hospital, Iksan, South Korea.'}, {'ForeName': 'Yu-Jin', 'Initials': 'YJ', 'LastName': 'Jung', 'Affiliation': 'Department of Occupational Therapy, Wonkwang University Hospital, Iksan, South Korea.'}, {'ForeName': 'Woo-Nam', 'Initials': 'WN', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Therapy, College of Health & Welfare Science, Yong-In University, Gyeonggi, South Korea.'}, {'ForeName': 'Hyeon-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Occupational Therapy, Wonkwang University Hospital, Iksan, South Korea.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2022.106330']
2469,35219937,"Night eating, weight, and health behaviors in adults participating in the Daily24 study.","BACKGROUND


Night eating syndrome (NES) is associated with adverse health outcomes. This study evaluated the relationship between night eating severity, weight, and health behaviors.
METHODS


Participants (N = 1017; 77.6% female, mean Body Mass Index (BMI) = 30.5, SD = 7.8 kg/m 2 , age = 51.1, SD = 15.0 years) were recruited from three health systems. Participants completed the Night Eating Questionnaire (NEQ) and questionnaires assessing sleep, chronotype, physical activity, diet, weight, and napping.
RESULTS


In the overall sample, higher NEQ scores were associated with higher BMI (p < .001) and consumption of sugar-sweetened beverages (p < .001), as well as lower fruit/vegetable consumption (p = .001). Higher NEQ scores were associated with increased odds of having overweight/obesity (p < .001), eating fast food (p < .001), moderate-vigorous physical activity (p = .005), and smoking (p = .004). Participants who exceeded the screening threshold for NES (n = 48, 4.7%) reported elevated BMI (p = .014), an increased likelihood of overweight/obesity (p = .004), greater sugar-sweetened beverages consumption (p < .001), napping less than twice per week (p = .029), shorter sleep duration (p = .012), and a later chronotype (M = 4:55, SD = 2:45).
CONCLUSION


Night eating severity was associated with obesity and intake of fast food and sugar-sweetened beverages. Interventions to address night eating and associated behaviors may enhance the efficacy of weight management interventions and promote engagement in positive health behaviors.",2022,"In the overall sample, higher NEQ scores were associated with higher BMI (p < .001) and consumption of sugar-sweetened beverages (p < .001), as well as lower fruit/vegetable consumption (p = .001).","['51.1, SD\xa0=\xa015.0\xa0years) were recruited from three health systems', 'Participants (N\xa0=\xa01017; 77.6% female, mean Body Mass Index (BMI)\xa0=\xa030.5, SD\xa0', 'adults participating in the Daily24 study']",[],"['Higher NEQ scores', 'shorter sleep duration', 'moderate-vigorous physical activity', 'consumption of sugar-sweetened beverages', 'Night eating, weight, and health behaviors', 'elevated BMI', 'NEQ scores', 'eating fast food', 'night eating severity, weight, and health behaviors', 'greater sugar-sweetened beverages consumption', 'likelihood of overweight/obesity', 'Night Eating Questionnaire (NEQ) and questionnaires assessing sleep, chronotype, physical activity, diet, weight, and napping']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}]",,0.0646504,"In the overall sample, higher NEQ scores were associated with higher BMI (p < .001) and consumption of sugar-sweetened beverages (p < .001), as well as lower fruit/vegetable consumption (p = .001).","[{'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Lent', 'Affiliation': 'School of Professional and Applied Psychology, Philadelphia College of Osteopathic Medicine, United States of America. Electronic address: michellele@pcom.edu.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Atwood', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The Johns Hopkins University School of Medicine, United States of America.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Bennett', 'Affiliation': 'The Johns Hopkins University, Bloomberg School of Public Health, United States of America; Division of General Internal Medicine, Department of Medicine, The Johns Hopkins University School of Medicine, United States of America.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Woolf', 'Affiliation': 'Department of Physiology, The Johns Hopkins University School of Medicine, United States of America.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, The Johns Hopkins University School of Medicine, United States of America.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'The Johns Hopkins University, Bloomberg School of Public Health, United States of America.'}, {'ForeName': 'Attia A', 'Initials': 'AA', 'LastName': 'Goheer', 'Affiliation': 'The Johns Hopkins University, Bloomberg School of Public Health, United States of America.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Division of Biomedical Informatics and Data Science, The Johns Hopkins University School of Medicine, United States of America.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'McTigue', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, United States of America.'}, {'ForeName': 'Harold P', 'Initials': 'HP', 'LastName': 'Lehmann', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, The Johns Hopkins University School of Medicine, United States of America.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Holzhauer', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, The Johns Hopkins University School of Medicine, United States of America.'}, {'ForeName': 'Janelle W', 'Initials': 'JW', 'LastName': 'Coughlin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The Johns Hopkins University School of Medicine, United States of America.'}]",Eating behaviors,['10.1016/j.eatbeh.2022.101605']
2470,35219923,"Long-term prophylactic efficacy of transcranial direct current stimulation in chronic migraine. A randomised, patient-assessor blinded, sham-controlled trial.","OBJECTIVE


To assess the prophylactic effect of anodal tDCS of the left motor cortex in patients with resistant chronic migraine (CM) and its long-term maintenance.
METHODS


In a patient-assessor blinded, sham-controlled trial, 36 patients were randomized to receive anodal tDCS (active group, n = 18) or sham tDCS (sham group, n = 18). The studied population was characterized by a previous failure of at least 3 classes of preventive drugs and a mean duration of migraine history of 26 years. The tDCS procedure consisted of an induction phase of 5 consecutive daily sessions (week 1) followed by a maintenance phase of 1 weekly session during the next 4 weeks and two bimonthly sessions in the next month, for a total of 11 sessions during 2 months. Anodal tDCS was delivered at 2 mA intensity for 20 min over the left motor cortex. The primary endpoint was the reduction in the monthly number of migraine attacks from baseline to each period of follow-up (months 1, 2, 3, 5) between the active and sham groups.
RESULTS


The monthly number of migraine attacks expressed as the percentage of reduction from baseline was significantly reduced in the active versus the sham group, from the end of first month (-21% ± 22 vs. -2% ±25, p = 0.019) to the end of follow-up (3-month post-treatment) (-32% ± 33 vs. -6% ±39, p = 0.011). At this time, the rate of responders, defined as a reduction of the monthly number of migraine attacks ≥30% from baseline, was significantly higher in the active group than in the sham group (50% vs. 14%, p = 0.043).
CONCLUSION


Our results show a marked prophylactic effect of anodal tDCS of the left motor cortex in resistant CM extending several months after the stimulation period, and suggest that this neuromodulatory approach may be part of the prophylactic alternatives available for CM.",2022,"Our results show a marked prophylactic effect of anodal tDCS of the left motor cortex in resistant CM extending several months after the stimulation period, and suggest that this neuromodulatory approach may be part of the prophylactic alternatives available for CM.","['36 patients', 'patients with resistant chronic migraine (CM) and its long-term maintenance', 'chronic migraine']","['Anodal tDCS', 'anodal tDCS', 'anodal tDCS (active group, n\u202f=\u202f18) or sham tDCS', 'transcranial direct current stimulation']","['migraine attacks', 'reduction in the monthly number of migraine attacks', 'monthly number of migraine attacks']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",36.0,0.497328,"Our results show a marked prophylactic effect of anodal tDCS of the left motor cortex in resistant CM extending several months after the stimulation period, and suggest that this neuromodulatory approach may be part of the prophylactic alternatives available for CM.","[{'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Hodaj', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, 38000, Grenoble, France; Univ. Grenoble Alpes, Inserm, U1216, Grenoble Institut Neurosciences, 38000, Grenoble, France. Electronic address: HHodaj@chu-grenoble.fr.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Payen', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, 38000, Grenoble, France; Univ. Grenoble Alpes, Inserm, U1216, Grenoble Institut Neurosciences, 38000, Grenoble, France.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Mick', 'Affiliation': 'Centre de la Douleur, Hôpital de Voiron, CHU Grenoble Alpes, 38000, Grenoble, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Vercueil', 'Affiliation': 'Service de Neurologie, CHU Grenoble Alpes, 38000, Grenoble, France.'}, {'ForeName': 'Enkelejda', 'Initials': 'E', 'LastName': 'Hodaj', 'Affiliation': ""Centre d'Investigation Clinique, CHU Grenoble Alpes, 38000, Grenoble, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Dumolard', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, 38000, Grenoble, France.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Noëlle', 'Affiliation': 'Service de Neurologie, CHU Grenoble Alpes, 38000, Grenoble, France.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Delon-Martin', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, U1216, Grenoble Institut Neurosciences, 38000, Grenoble, France.'}, {'ForeName': 'Jean-Pascal', 'Initials': 'JP', 'LastName': 'Lefaucheur', 'Affiliation': 'EA 4391, Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor, Université Paris Est Créteil, Créteil, France.'}]",Brain stimulation,['10.1016/j.brs.2022.02.012']
2471,35219908,A clinical study for the treatment of onychomycosis patients using a novel ROS producing onychomycosis treatment when compared against 5% amorolfine topical lacquer to reduce the visible size of infected toenails.,"BACKGROUND


Onychomycosis affects approximately 5% of the population worldwide without satisfactory treatment options regarding efficacy and safety. The aim of this first in human study was to compare the safety and efficacy of the novel compound Mycosinate® against an approved toenail lacquer containing 5% Amorolfine.
DESIGN


A randomized, single-blinded, controlled parallel group study with allocation concealment was carried out.
METHODS


Thirty-eight participants either used the novel compound Mycosinate® or an approved toenail lacquer containing 5% Amorolfine for topical application in their own homes. Outcome measures included a) % change in area of clear visible toenail, b) mycological cure rate and c) safety assessments.
RESULTS


Statically significant differences for % change in area of clear visible toenail (p<0.05) of 39.8, 40.0 and 70.7 in favour of Mycosinate® were noted at time points 6 weeks, 12 weeks, and 6 months respectively when compared to Amorolfine. No statistically significant differences were noted for mycological cure rates. No adverse events, serious adverse events or deaths occurred for either treatment.
CONCLUSION


Mycosinate® is a promising novel topical onychomycosis treatment with high rates of efficacy and excellent safety profile. Further clinical trials are warranted. (EU Clinical Trials Register 2018/000294/78).",2022,"Statically significant differences for % change in area of clear visible toenail (p<0.05) of 39.8, 40.0 and 70.7 in favour of Mycosinate® were noted at time points 6 weeks, 12 weeks, and 6 months respectively when compared to Amorolfine.","['Thirty-eight participants either used the novel compound Mycosinate® or an approved toenail lacquer containing 5% Amorolfine for topical application in their own homes', 'onychomycosis patients']",['novel compound Mycosinate®'],"['area of clear visible toenail', 'adverse events, serious adverse events or deaths', 'mycological cure rates', 'safety and efficacy', ' % change in area of clear visible toenail, b) mycological cure rate and c) safety assessments', 'visible size of infected toenails']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C0022902', 'cui_str': 'Lacquer'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0051736', 'cui_str': 'Amorolfine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205198', 'cui_str': 'Compound'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",38.0,0.247511,"Statically significant differences for % change in area of clear visible toenail (p<0.05) of 39.8, 40.0 and 70.7 in favour of Mycosinate® were noted at time points 6 weeks, 12 weeks, and 6 months respectively when compared to Amorolfine.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ehrensberger', 'Affiliation': 'Nektr Technologies Ltd., Finisklin Business Park, Sligo, Ireland.'}, {'ForeName': 'C W C', 'Initials': 'CWC', 'LastName': 'Boal', 'Affiliation': 'Nektr Technologies Ltd., Finisklin Business Park, Sligo, Ireland. Electronic address: cboal@nektrtechnologies.com.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Brennan', 'Affiliation': 'Institute of Technology Sligo, Ash Lane, Ballinode, Sligo, Ireland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Barrett', 'Affiliation': 'Institute of Technology Sligo, Ash Lane, Ballinode, Sligo, Ireland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Makarus', 'Affiliation': 'Bray Chiropody and Podiatry, The Mews Rear Of 1, Prince of Wales Terrace, Wyndham Park, Bray, Co. Wicklow, Ireland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Callanan', 'Affiliation': 'Bray Chiropody and Podiatry, The Mews Rear Of 1, Prince of Wales Terrace, Wyndham Park, Bray, Co. Wicklow, Ireland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Spillane', 'Affiliation': 'Carlton Clinic, Bray Primary Care Centre, Killarney Road, Bray, Co. Wicklow, Ireland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Patton', 'Affiliation': 'Institute of Technology Sligo, Ash Lane, Ballinode, Sligo, Ireland.'}]",Journal de mycologie medicale,['10.1016/j.mycmed.2022.101256']
2472,35220182,Prognostic and predictive value of β-blockers in the EORTC 1325/KEYNOTE-054 phase III trial of pembrolizumab versus placebo in resected high-risk stage III melanoma.,"BACKGROUND


β-adrenergic receptors are upregulated in melanoma cells and contribute to an immunosuppressive, pro-tumorigenic microenvironment. This study investigated the prognostic and predictive value of β-adrenoreceptor blockade by β-blockers in the EORTC1325/KEYNOTE-054 randomised controlled trial.
METHODS


Patients with resected stage IIIA, IIIB or IIIC melanoma and regional lymphadenectomy received 200 mg of adjuvant pembrolizumab (n = 514) or placebo (n = 505) every three weeks for one year or until recurrence or unacceptable toxicity. At a median follow-up of 3 years, pembrolizumab prolonged recurrence-free survival (RFS) compared to placebo (hazard ratio (HR) 0.56, 95% confidence interval (CI) 0.47-0.68). β-blocker use was defined as oral administration of any β-blocker within 30 days of randomisation. A multivariable Cox proportional hazard model was used to estimate the HR for the association between the use of β-blockers and RFS.
RESULTS


Ninety-nine (10%) of 1019 randomised patients used β-blockers at baseline. β-blockers had no independent prognostic effect on RFS: HR 0.96 (95% CI 0.70-1.31). The HRs of RFS associated with β-blocker use were 0.67 (95% CI 0.38-1.19) in the pembrolizumab arm and 1.15 (95% CI 0.80-1.66) in the placebo arm. The HR of RFS associated with pembrolizumab compared to placebo was 0.34 (95% CI 0.18-0.65) among β-blocker users and 0.59 (95% CI 0.48-0.71) among those not using β-blockers.
CONCLUSIONS


This study suggests no prognostic effect of β-blockers in resected high-risk stage III melanoma. However, β-blockers may predict improved efficacy of adjuvant pembrolizumab treatment. The combination of immunotherapy with β-blockers merits further investigation. This study is registered with ClinicalTrials.gov, NCT02362594, and EudraCT, 2014-004944-37.",2022,β-blockers had no independent prognostic effect on RFS: HR 0.96 (95% CI 0.70-1.31).,"['Patients with resected stage IIIA, IIIB or IIIC melanoma and regional', 'n\xa0=\xa0514) or', 'resected high-risk stage III melanoma', 'Ninety-nine (10%) of 1019']","['β-adrenoreceptor blockade', 'pembrolizumab', 'placebo', 'lymphadenectomy received 200\xa0mg of adjuvant pembrolizumab']","['pembrolizumab prolonged recurrence-free survival (RFS', 'HR of RFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0450318', 'cui_str': '1019'}]","[{'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",,0.681387,β-blockers had no independent prognostic effect on RFS: HR 0.96 (95% CI 0.70-1.31).,"[{'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Kennedy', 'Affiliation': 'University of Manchester, Oxford Road, Manchester, M13 9PL, United Kingdom. Electronic address: ojk@doctors.org.uk.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Valpione', 'Affiliation': 'Cancer Research UK Manchester Institute, Manchester and the Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gandini', 'Affiliation': 'Molecular and Pharmaco-Epidemiology Unit, European Institute of Oncology, IRCCS, Milano, Italy.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Netherlands.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, And Mater and Royal North Shore Hospitals, Sydney, NSW, Australia.'}, {'ForeName': 'Victoria G', 'Initials': 'VG', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, Brisbane, QLD, Australia.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils de Lyon Cancer Institute, Lyon, France.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Haydon', 'Affiliation': 'Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Meshcheryakov', 'Affiliation': 'NN Blokhin Cancer Research Center, Moscow, Russian Federation.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Khattak', 'Affiliation': 'Fiona Stanley Hospital & Edith Cowan University, Perth, WA, Australia.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Westmead and Blacktown Hospitals, Melanoma Institute Australia and the University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Puig', 'Affiliation': 'Hospital Clinic de Barcelona, Universitat de Barcelona, Spain &Centro de Investigación Biomédica en Red de Enfermedades Raras (CIBERER), Instituto de Salud Carlos III, Barcelona, Spain.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Naples, Italy.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen and German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Koornstra', 'Affiliation': 'Radboud University Medical Center Nijmegen, Nijmegen, Netherlands.'}, {'ForeName': 'Leonel', 'Initials': 'L', 'LastName': 'Hernandez-Aya', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Di Giacomo', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Alfonsus J M', 'Initials': 'AJM', 'LastName': 'van den Eertwegh', 'Affiliation': 'Amsterdam University Medical Center, Location VUMC, Amsterdam, Netherlands.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix Marseille University, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center, Hannover Medical School, Hannover, and Department of Dermatology, Johannes Wesling Klinikum Minden, Ruhr University Bochum, Minden, Germany.'}, {'ForeName': 'Rahima', 'Initials': 'R', 'LastName': 'Jamal', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal (CHUM), Centre de recherche du CHUM, Montreal, QC, Canada.""}, {'ForeName': 'Alexander C J', 'Initials': 'ACJ', 'LastName': 'van Akkooi', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Netherlands.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy and Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Comprehensive Cancer Center Munich, Munich, Germany; Division of Cancer Sciences, University of Manchester and Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lorigan', 'Affiliation': 'University of Perugia, Santa Maria Misericordia Hospital, Perugia, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandala', 'Affiliation': 'Princess Máxima Center and University Medical Center Utrecht, Utrecht, the Netherlands.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.01.017']
2473,35220180,Pectoserratus plane block versus erector spinae plane block for postoperative opioid consumption and acute and chronic pain after breast cancer surgery: A randomized controlled trial.,"STUDY OBJECTIVE


Breast cancer is quite common in women, and surgery is the most effective treatment in most cases. This study compared the effects of ultrasound (US)-guided erector spinae plane block (ESPB) and pectoserratus plane block (PSPB) on the postoperative opioid consumption and acute and chronic pain in patients after breast cancer surgery.
DESIGN


Prospective, randomized, single-blind.
SETTING


University hospital.
PATIENTS


This study included 90 patients (ASA I-II) who underwent segmental mastectomy and sentinel lymph node biopsy at the hospital of Ondokuz Mayis University, Samsun.
INTERVENTIONS


The patients were divided into the ESPB group, PSPB group, and control group. Intraoperatively, all patients were administered intravenous tenoxicam (20 mg) and paracetamol (1 g) as part of multimodal analgesia. Intravenous morphine via patient-controlled analgesia was administered in all groups postoperatively.
MEASUREMENTS


The primary outcome was the total morphine consumption in the first 24 h after surgery. The secondary outcomes included visual analog scale pain scores of the arm at rest and at abduction in the first 24 h and at 3 months postoperatively, intraoperative remifentanil consumption, number of patients requesting rescue analgesia, incidence of nausea and vomiting, time to the first request for analgesia via patient-controlled analgesia.
MAIN RESULTS


Postoperative 24-h morphine consumption, visual analog scale scores at rest and at abduction, and intraoperative remifentanil consumption were lower in the ESPB and PSPB groups than in the control group. Time to the first request for analgesia via patient controlled analgesia was longer in the ESPB and PSPB groups than in the control group. In the PSPB group, none of the patients needed rescue analgesia.
CONCLUSIONS


US-guided ESPB and PSPB performed in patients who underwent breast cancer surgery showed similar and modest analgesic effects on the postoperative opioid consumption and acute and chronic pain scores.",2022,Time to the first request for analgesia via patient controlled analgesia was longer in the ESPB and PSPB groups than in the control group.,"['90 patients (ASA I-II) who underwent segmental mastectomy and sentinel lymph node biopsy at the hospital of Ondokuz Mayis University, Samsun', 'patients after breast cancer surgery', 'University hospital', 'postoperative opioid consumption and acute and chronic pain after breast cancer surgery']","['intravenous tenoxicam', 'Pectoserratus plane block versus erector spinae plane block', 'ultrasound (US)-guided erector spinae plane block (ESPB) and pectoserratus plane block (PSPB', 'ESPB', 'Intravenous morphine', 'paracetamol', 'PSPB']","['Postoperative 24-h morphine consumption, visual analog scale scores at rest and at abduction, and intraoperative remifentanil consumption', 'visual analog scale pain scores of the arm at rest and at abduction in the first 24\xa0h and at 3\xa0months postoperatively, intraoperative remifentanil consumption, number of patients requesting rescue analgesia, incidence of nausea and vomiting, time to the first request for analgesia via patient-controlled analgesia', 'total morphine consumption', 'postoperative opioid consumption and acute and chronic pain scores', 'postoperative opioid consumption and acute and chronic pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0024885', 'cui_str': 'Partial mastectomy'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0076096', 'cui_str': 'tenoxicam'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332153', 'cui_str': 'Requested by patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",90.0,0.24928,Time to the first request for analgesia via patient controlled analgesia was longer in the ESPB and PSPB groups than in the control group.,"[{'ForeName': 'Caner', 'Initials': 'C', 'LastName': 'Genc', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Cengiz', 'Initials': 'C', 'LastName': 'Kaya', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Sezgin', 'Initials': 'S', 'LastName': 'Bilgin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Burhan', 'Initials': 'B', 'LastName': 'Dost', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey. Electronic address: burhandost@hotmail.com.'}, {'ForeName': 'Yasemin Burcu', 'Initials': 'YB', 'LastName': 'Ustun', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}, {'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Koksal', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2022.110691']
2474,35220140,Impact of lemborexant treatment on insomnia severity: analyses from a 12-month study of adults with insomnia disorder.,"OBJECTIVE/BACKGROUND


Evaluate changes in insomnia severity in subjects with moderate to severe insomnia (Insomnia Severity Index [ISI] score ≥15) treated for 12 months nightly with lemborexant.
PATIENTS/METHODS


This phase 3 randomized study comprised two 6-month treatment periods. In Period 1, 949 subjects were randomized to placebo, lemborexant 5 mg (LEM5) or 10 mg (LEM10). In Period 2, placebo subjects were rerandomized to LEM5 or LEM10; subjects initially randomized to lemborexant continued their assigned treatment. Insomnia severity was assessed using baseline ISI and 1-, 3-, 6-, 9-, and 12-month post-treatment scores.
RESULTS


Mean ISI scores improved significantly across treatment groups and disease severities, with greater decreases from baseline in the LEM5 and LEM10 versus placebo groups at months 1 (-7.1, -7.2, -5.2, respectively), 3 (-8.6, -8.9, -6.1, respectively), and 6 (-9.9, -9.8, -7.2 respectively); ISI score improvements were maintained with LEM5 and LEM10 at months 9 (-11.1 and -11.2, respectively) and 12 (-11.5 and -11.2, respectively). At months 1, 3, and 6, significantly more treatment responders (≥7-point ISI score decrease from baseline) were observed with LEM5 (44%-57%) and LEM10 (44%-52%) versus placebo (30%-41%). At months 1, 3, and 6, more remitters (ISI total score <10 and < 8) were observed with LEM5 (30%-44% and 22%-34%, respectively) and LEM10 (31%-41% and 22%-31%, respectively) versus placebo (18%-28% and 11%-21%, respectively).
CONCLUSIONS


Lemborexant significantly reduced insomnia severity for 12 months and increased clinically meaningful response and remission rates versus placebo.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39.",2022,"RESULTS


Mean ISI scores improved significantly across treatment groups and disease severities, with greater decreases from baseline in the LEM5 and LEM10 versus placebo groups at months 1 (-7.1, -7.2, -5.2, respectively), 3 (-8.6, -8.9, -6.1, respectively), and 6 (-9.9, -9.8, -7.2 respectively); ISI score improvements were maintained with LEM5 and LEM10 at months 9 (-11.1 and -11.2, respectively) and 12 (-11.5 and -11.2, respectively).","['subjects with moderate to severe insomnia (Insomnia Severity Index [ISI] score ≥15) treated for 12 months nightly with lemborexant', 'adults with insomnia disorder', '949 subjects']","['placebo, lemborexant 5\xa0mg (LEM5) or 10\xa0mg (LEM10', 'lemborexant', 'placebo', 'lemborexant treatment']","['meaningful response and remission rates', 'Mean ISI scores', 'LEM10', 'Insomnia severity', 'insomnia severity', 'ISI score improvements']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",949.0,0.24397,"RESULTS


Mean ISI scores improved significantly across treatment groups and disease severities, with greater decreases from baseline in the LEM5 and LEM10 versus placebo groups at months 1 (-7.1, -7.2, -5.2, respectively), 3 (-8.6, -8.9, -6.1, respectively), and 6 (-9.9, -9.8, -7.2 respectively); ISI score improvements were maintained with LEM5 and LEM10 at months 9 (-11.1 and -11.2, respectively) and 12 (-11.5 and -11.2, respectively).","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Henry Ford Hospital, 2921 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Rosenberg', 'Affiliation': 'NeuroTrials Research Inc., 5887 Glenridge Drive, NE Suite 400, Atlanta, GA, 30328, USA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': ""Université Laval, 2325 Rue de L'Université, Quebec City, QC, G1V 0A6, Canada.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Yardley', 'Affiliation': 'Eisai Ltd., Mosquito Way, Hatfield, AL10 9SN, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pinner', 'Affiliation': 'Eisai Ltd., Mosquito Way, Hatfield, AL10 9SN, UK.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Perdomo', 'Affiliation': 'Eisai Inc., 200 Metro Blvd, Nutley, NJ, 07110, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Atkins', 'Affiliation': 'Eisai Inc., 200 Metro Blvd, Nutley, NJ, 07110, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pappadopulos', 'Affiliation': 'Eisai Inc., 200 Metro Blvd, Nutley, NJ, 07110, USA.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc., 200 Metro Blvd, Nutley, NJ, 07110, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc., 200 Metro Blvd, Nutley, NJ, 07110, USA. Electronic address: Margaret_Moline@eisai.com.'}]",Sleep medicine,['10.1016/j.sleep.2022.01.024']
2475,35220062,What about the role of the cerebellum in music-associated functional recovery? A secondary EEG analysis of a randomized clinical trial in patients with Parkinson disease.,"Rhythmic Auditory Stimulation (RAS) has been shown to be of help in an effective gait training of people with idiopathic Parkinson's disease (PD). The cerebellum may play an important role in RAS aftereffects by compensating the detrimental internal clock for automatic and rhythmic motricity. However, the neurophysiological mechanisms underlying RAS aftereffects are still poorly understood. In the present study, we tested the contribution of the cerebellum to RAS-based gait training aftereffects in people with PD by examining cerebellum-cerebral connectivity indices using standard EEG recording. We enrolled 50 patients with PD who were randomly assigned to two different modalities of treadmill gait training using GaitTrainer3 with and without RAS (non_RAS) during an 8-week training program. We measured clinical and kinematic gait indices and electrophysiological data (standard EEG recording during walking on GaitTrainer3) of both the gait trainings. We found that the greater improvement in gait performance following RAS than non_RAS training, as per clinical and kinematic assessment, was paralleled by a more evident reshape of cerebellum-brain functional connectivity with regard to specific brain areas (pre-motor, sensorimotor and temporal cortices) and gait-cycle phases (mainly 25-75% of the gait cycle duration). These findings suggest that the cerebellum mediates the reshape of sensorimotor rhythms and fronto-centroparietal connectivity in relation to specific gait-cycle phases. This may be consistent with a recovery of the internal timing mechanisms generating and controlling motor rhythmicity, eventually improving gait performance. The precise definition of the cerebellar role to gait functional recovery in people with PD may be crucial to create patient-tailored rehabilitative approaches.",2022,Rhythmic Auditory Stimulation (RAS) has been shown to be of help in an effective gait training of people with idiopathic Parkinson's disease (PD).,"['patients with Parkinson disease', 'people with PD', '50 patients with PD', ""people with idiopathic Parkinson's disease (PD""]","['treadmill gait training using GaitTrainer3 with and without RAS (non_RAS', 'Rhythmic Auditory Stimulation (RAS']","['clinical and kinematic gait indices and electrophysiological data (standard EEG recording during walking on GaitTrainer3', 'specific brain areas (pre-motor, sensorimotor and temporal cortices) and gait-cycle phases', 'gait performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Acoustic'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",50.0,0.0250858,Rhythmic Auditory Stimulation (RAS) has been shown to be of help in an effective gait training of people with idiopathic Parkinson's disease (PD).,"[{'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Naro', 'Affiliation': 'IRCCS Centro Neurolesi Bonino Pulejo, Messina, Italy.'}, {'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Pignolo', 'Affiliation': 'Istituto di Riabilitazione S.Anna, Crotone, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Bruschetta', 'Affiliation': 'Azienda Ospedaliera Universitaria Policlinico G.Martino, Messina, Italy.'}, {'ForeName': 'Rocco Salvatore', 'Initials': 'RS', 'LastName': 'Calabrò', 'Affiliation': 'IRCCS Centro Neurolesi Bonino Pulejo, Messina, Italy. Electronic address: salbro77@tiscali.it.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2022.02.012']
2476,35220473,Prophylactic melatonin for delirium in intensive care (Pro-MEDIC): a randomized controlled trial.,"PURPOSE


Delirium is common in the critically ill, highly distressing to patients and families and associated with increased morbidity and mortality. Results of studies on preventative use of melatonin in various patient groups have produced mixed results. The aim of this study was to determine whether administration of melatonin decreases the prevalence of delirium in critically ill patients.
METHODS


Multicentre, randomized, placebo-controlled, double-blind trial across 12 Australian ICUs recruiting patients from July 2016 to September 2019. Patients of at least 18 years requiring ICU admission with an expected length of stay (LOS) greater than 72 h; enrolled within 48 h of ICU admission. Indistinguishable liquid melatonin (4 mg; n = 419) or placebo (n = 422) was administered enterally at 21:00 h for 14 consecutive nights or until ICU discharge. The primary outcome was the proportion of delirium-free assessments, as a marker of delirium prevalence, within 14 days or before ICU discharge. Delirium was assessed twice daily using the Confusion Assessment Method for ICU (CAM-ICU) score. Secondary outcomes included sleep quality and quantity, hospital and ICU LOS, and hospital and 90-day mortality.
RESULTS


A total of 847 patients were randomized into the study with 841 included in data analysis. Baseline characteristics of the participants were similar. There was no significant difference in the average proportion of delirium-free assessments per patient between the melatonin and placebo groups (79.2 vs 80% respectively, p = 0.547). There was no significant difference in any secondary outcomes including ICU LOS (median: 5 vs 5 days, p = 0.135), hospital LOS (median: 14 vs 12 days, p = 0816), mortality at any time point including at 90 days (15.5 vs 15.6% p = 0.948), nor in the quantity or quality of sleep. There were no serious adverse events reported in either group.
CONCLUSION


Enteral melatonin initiated within 48 h of ICU admission did not reduce the prevalence of delirium compared to placebo. These findings do not support the routine early use of melatonin in the critically ill.",2022,"There was no significant difference in any secondary outcomes including ICU LOS (median: 5 vs 5 days, p = 0.135), hospital LOS (median: 14 vs 12 days, p = 0816), mortality at any time point including at 90 days (15.5 vs 15.6% p = 0.948), nor in the quantity or quality of sleep.","['critically ill patients', 'Patients of at least 18\xa0years requiring ICU admission with an expected length of stay (LOS) greater than 72\xa0h; enrolled within 48\xa0h of ICU admission', '847 patients were randomized into the study with 841 included in data analysis', '12 Australian ICUs recruiting patients from July 2016 to September 2019']","['melatonin', 'placebo', 'Prophylactic melatonin', 'Enteral melatonin', 'Indistinguishable liquid melatonin']","['quantity or quality of sleep', 'serious adverse events', 'average proportion of delirium-free assessments per patient', 'ICU LOS', 'hospital LOS', 'prevalence of delirium', 'proportion of delirium-free assessments, as a marker of delirium prevalence, within 14\xa0days or before ICU discharge', 'mortality', 'Delirium', 'sleep quality and quantity, hospital and ICU LOS, and hospital and 90-day mortality']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",847.0,0.639667,"There was no significant difference in any secondary outcomes including ICU LOS (median: 5 vs 5 days, p = 0.135), hospital LOS (median: 14 vs 12 days, p = 0816), mortality at any time point including at 90 days (15.5 vs 15.6% p = 0.948), nor in the quantity or quality of sleep.","[{'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Wibrow', 'Affiliation': 'Intensive Care Unit, Sir Charles Gairdner Hospital, Nedlands, WA, Australia. bradley.wibrow@health.wa.gov.au.'}, {'ForeName': 'F Eduardo', 'Initials': 'FE', 'LastName': 'Martinez', 'Affiliation': 'Intensive Care Unit, John Hunter Hospital, Newcastle, NSW, Australia.'}, {'ForeName': 'Erina', 'Initials': 'E', 'LastName': 'Myers', 'Affiliation': 'Intensive Care Unit, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chapman', 'Affiliation': 'Intensive Care Unit, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Kwok M', 'Initials': 'KM', 'LastName': 'Ho', 'Affiliation': 'Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Regli', 'Affiliation': 'Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hawkins', 'Affiliation': 'Intensive Care Unit, Joondalup Health Campus, Joondalup, WA, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ford', 'Affiliation': 'Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Frank M P', 'Initials': 'FMP', 'LastName': 'van Haren', 'Affiliation': 'Intensive Care Unit, St George Hospital, Sydney, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Wyer', 'Affiliation': 'Intensive Care Unit, Gosford and Wyong Hospitals, Gosford, Australia.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'McCaffrey', 'Affiliation': 'Intensive Care Unit, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Rashid', 'Affiliation': 'Intensive Care Unit, Mater Hospital, Newcastle, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Kelty', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Anstey', 'Affiliation': 'Intensive Care Unit, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}]",Intensive care medicine,['10.1007/s00134-022-06638-9']
2477,35220449,Drug-coated balloons for small coronary artery disease in patients with chronic kidney disease: a pre-specified analysis of the BASKET-SMALL 2 trial.,"BACKGROUND


Data on the safety and efficacy of drug-coated balloon (DCB) compared to drug-eluting stent (DES) in patients with chronic kidney disease (CKD) are scarce, particularly at long term. This pre-specified analysis aimed to investigate the 3-year efficacy and safety of DCB versus DES for small coronary artery disease (< 3 mm) according to renal function at baseline.
METHODS


BASKET-SMALL-2 was a large multi-center, randomized, controlled trial that tested the efficacy and safety of DCBs (n = 382) against DESs (n = 376) in small vessel disease. CKD was defined as eGFR < 60 ml/min/1.73m 2 . The primary endpoint was the composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularization (MACE) during 3 years.
RESULTS


A total of 174/758 (23%) patients had CKD, out of which 91 were randomized to DCB and 83 to DES implantation. The primary efficacy outcome during 3 years was similar in both, DCB and DES patients (HR 0.98; 95%-CI 0.67-1.44; p = 0.937) and patients with and without CKD (HR 1.18; 95%-CI 0.76-1.83; p = 0.462), respectively. Rates of cardiac death and all-cause death were significantly higher among patients with CKD but not affected by treatment with DCB or DES. Major bleeding events were lower in the DCB when compared to the DES group (12 vs. 3, HR 0.26; 95%-CI 0.07-0.92; p = 0.037) and not influenced by presence of CKD.
CONCLUSIONS


The long-term efficacy and safety of DCB was similar in patients with and without CKD. The use of DCB was associated with significantly fewer major bleeding events (NCT01574534). Central Illustration. Drug-coated balloon versus drug-eluting stents in small coronary artery disease with and without chronic kidney disease, a prespecified subgroup analysis of the BASKET-SMALL 2 trial.",2022,Rates of cardiac death and all-cause death were significantly higher among patients with CKD but not affected by treatment with DCB or DES.,"['patients with and without CKD', 'A total of 174/758 (23%) patients had CKD, out of which 91 were randomized to', 'small coronary artery disease with and without chronic kidney disease', 'patients with chronic kidney disease (CKD', 'n\u2009=\u2009382) against DESs (n\u2009=\u2009376) in small vessel disease', 'patients with chronic kidney disease']","['drug-coated balloon (DCB', 'DES', 'DCB', 'drug-eluting stent (DES', 'DCB versus DES', 'Drug-coated balloons', 'Drug-coated balloon versus drug-eluting stents', 'DCBs']","['Rates of cardiac death and all-cause death', 'CKD', 'major bleeding events', '3-year efficacy and safety', 'composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularization (MACE', 'Major bleeding events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",91.0,0.0958693,Rates of cardiac death and all-cause death were significantly higher among patients with CKD but not affected by treatment with DCB or DES.,"[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mahfoud', 'Affiliation': 'Universitätsklinikum des Saarlandes, Saarland University, Kirrberger Str. 1, IMED, Geb. 41.1, 66421, Homburg, Saar, Germany. Felix.Mahfoud@uks.eu.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Farah', 'Affiliation': 'Knappschaftskrankenhaus, Klinikum Westfalen, Dortmund, Germany.'}, {'ForeName': 'Marc-Alexander', 'Initials': 'MA', 'LastName': 'Ohlow', 'Affiliation': 'SRH Wald-Klinikum, Gera, Germany.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Mangner', 'Affiliation': 'Herzzentrum Dresden, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wöhrle', 'Affiliation': 'Department of Cardiology and Intensive Care, Medical Campus Lake Constance, Friedrichshafen, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Möbius-Winkler', 'Affiliation': 'University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weilenmann', 'Affiliation': 'Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Leibundgut', 'Affiliation': 'Cantonal Hospital Baselland, Liestal, Switzerland.'}, {'ForeName': 'Florim', 'Initials': 'F', 'LastName': 'Cuculi', 'Affiliation': 'Cantonal Hospital Luzern, Luzern, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Gilgen', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kaiser', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cattaneo', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Scheller', 'Affiliation': 'Universitätsklinikum des Saarlandes, Saarland University, Kirrberger Str. 1, IMED, Geb. 41.1, 66421, Homburg, Saar, Germany.'}, {'ForeName': 'Raban V', 'Initials': 'RV', 'LastName': 'Jeger', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-022-01995-3']
2478,35220442,UVB-exposed wheat germ oil increases serum 25-hydroxyvitamin D 2  without improving overall vitamin D status: a randomized controlled trial.,"PURPOSE


This study investigated whether UVB-exposed wheat germ oil (WGO) is capable to improving the vitamin D status in healthy volunteers.
METHODS


A randomized controlled human-intervention trial in parallel design was conducted in Jena (Germany) between February and April. Ultimately, 46 healthy males and females with low mean 25-hydroxyvitamin D (25(OH)D) levels (34.9 ± 10.6 nmol/L) were randomized into three groups receiving either no WGO oil (control, n = 14), 10 g non-exposed WGO per day (- UVB WGO, n = 16) or 10 g WGO, which was exposed for 10 min to ultraviolet B-light (UVB, intensity 500-630 µW/cm 2 ) and provided 23.7 µg vitamin D (22.9 µg vitamin D 2  and 0.89 µg vitamin D 3 ) (+ UVB WGO, n = 16) for 6 weeks. Blood was obtained at baseline, after 3 and 6 weeks and analyzed for serum vitamin D-metabolite concentrations via LC-MS/MS.
RESULTS


Participants who received the UVB-exposed WGO were characterized by an increase of circulating 25(OH)D 2  after 3 and 6 weeks of intervention. However, the 25(OH)D 3  concentrations decreased in the + UVB WGO group, while they increased in the control groups. Finally, the total 25(OH)D concentration (25(OH)D 2  + 25(OH)D 3 ) in the + UVB WGO group was lower than that of the non-WGO receiving control group after 6 weeks of treatment. In contrast, circulating vitamin D (vitamin D 2  + vitamin D 3 ) was higher in the + UVB WGO group than in the control group receiving no WGO.
CONCLUSION


UVB-exposed WGO containing 23.7 µg vitamin D can increase 25(OH)D 2  levels but do no improve total serum levels of 25(OH)D of vitamin D-insufficient subjects.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03499327 (registered, April 13, 2018).",2022,"RESULTS


Participants who received the UVB-exposed WGO were characterized by an increase of circulating 25(OH)D 2  after 3 and 6 weeks of intervention.","['Jena (Germany) between February and April', '46 healthy males and females with low mean 25-hydroxyvitamin D (25(OH)D) levels (34.9\u2009±\u200910.6\xa0nmol/L', 'healthy volunteers']","['UVB-exposed wheat germ oil increases serum', 'UVB-exposed wheat germ oil (WGO', 'no WGO oil (control, n\u2009=\u200914), 10\xa0g non-exposed WGO', '25-hydroxyvitamin D 2  without improving overall vitamin D status']","['serum vitamin D-metabolite concentrations', 'circulating vitamin D', 'total serum levels', '25(OH)D 3  concentrations', 'total 25(OH)D concentration']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0244994', 'cui_str': 'Wheat germ oil'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0000343', 'cui_str': '25-hydroxy ergocalciferol'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",46.0,0.25372,"RESULTS


Participants who received the UVB-exposed WGO were characterized by an increase of circulating 25(OH)D 2  after 3 and 6 weeks of intervention.","[{'ForeName': 'Anja C', 'Initials': 'AC', 'LastName': 'Bailer', 'Affiliation': 'Institute of Agricultural and Nutritional Sciences, Martin Luther University Halle-Wittenberg, Von-Danckelmann-Platz 2, 06120, Halle (Saale), Germany.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Philipp', 'Affiliation': 'Institute of Agricultural and Nutritional Sciences, Martin Luther University Halle-Wittenberg, Von-Danckelmann-Platz 2, 06120, Halle (Saale), Germany.'}, {'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'Staudt', 'Affiliation': 'Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD) Halle-Jena-Leipzig, Jena, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Weidauer', 'Affiliation': 'Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD) Halle-Jena-Leipzig, Jena, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kiehntopf', 'Affiliation': 'Institute of Clinical Chemistry and Laboratory Diagnostics, University Hospital Jena, 07747, Jena, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lorkowski', 'Affiliation': 'Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD) Halle-Jena-Leipzig, Jena, Germany.'}, {'ForeName': 'Gabriele I', 'Initials': 'GI', 'LastName': 'Stangl', 'Affiliation': 'Institute of Agricultural and Nutritional Sciences, Martin Luther University Halle-Wittenberg, Von-Danckelmann-Platz 2, 06120, Halle (Saale), Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dawczynski', 'Affiliation': 'Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD) Halle-Jena-Leipzig, Jena, Germany. christine.dawczynski@uni-jena.de.'}]",European journal of nutrition,['10.1007/s00394-022-02827-w']
2479,35220432,Can hysterosalpingo-foam sonography replace hysterosalpingography as first-choice tubal patency test? A randomized non-inferiority trial.,"STUDY QUESTION


Does hysterosalpingo-foam sonography (HyFoSy) lead to similar pregnancy outcomes, compared with hysterosalpingography (HSG), as first-choice tubal patency test in infertile couples?
SUMMARY ANSWER


HyFoSy and HSG produce similar findings in a majority of patients and clinical management based on the results of either HyFoSy or HSG, leads to comparable pregnancy outcomes. HyFoSy is experienced as significantly less painful.
WHAT IS KNOWN ALREADY


Traditionally, tubal patency testing during fertility work-up is performed by HSG. HyFoSy is an alternative imaging technique lacking ionizing radiation and iodinated contrast medium exposure which is less expensive than HSG. Globally, there is a shift towards the use of office-based diagnostic methods, such as HyFoSy.
STUDY DESIGN, SIZE, DURATION


This multicentre, prospective, comparative study with a randomized design was conducted in 26 hospitals in The Netherlands. Participating women underwent both HyFoSy and HSG in randomized order. In case of discordant results, women were randomly allocated to either a management strategy based on HyFoSy or one based on HSG.
PARTICIPANTS/MATERIALS, SETTING, METHODS


We included infertile women between 18 and 41 years old who were scheduled for tubal patency testing during their fertility work-up. Women with anovulatory cycles not responding to ovulation induction, endometriosis, severe male infertility or a known iodine contrast allergy were excluded. The primary outcome for the comparison of the HyFoSy- and HSG-based strategies was ongoing pregnancy leading to live birth within 12 months after inclusion in an intention-to-treat analysis.
MAIN RESULTS AND THE ROLE OF CHANCE


Between May 2015 and January 2019, 1026 women underwent HyFoSy and HSG. HyFoSy was inconclusive in 97 of them (9.5%), HSG was inconclusive in 30 (2.9%) and both were inconclusive in 9 (0.9%). In 747 women (73%) conclusive tests results were concordant. Of the 143/1026 (14%) with discordant results, 105 were randomized to clinical management based on the results of either HyFoSy or HSG. In this group, 22 of the 54 women (41%) allocated to management based on HyFoSy and 25 of 51 women (49%) allocated to management based on HSG had an ongoing pregnancy leading to live birth (Difference -8%; 95% CI: -27% to 10%). In total, clinical management based on the results of HyFoSy was estimated to lead to a live birth in 474 of 1026 women (46%) versus 486 of 1026 (47%) for management based on HSG (Difference -1.2%; 95% CI: -3.4% to 1.5%). Given the pre-defined margin of -2%, statistically significant non-inferiority of HyFoSy relative to HSG could not be demonstrated (P = 0.27). The mean pain score for HyFoSy on the 1-10 Visual Analogue Scale (VAS) was 3.1 (SD 2.2) and the mean VAS pain score for HSG was 5.4 (SD 2.5; P for difference < 0.001).
LIMITATIONS, REASONS FOR CAUTION


Since all women underwent both tubal patency tests, no conclusions on a direct therapeutic effect of tubal flushing could be drawn.
WIDER IMPLICATIONS OF THE FINDINGS


HyFoSy or HSG produce similar tubal pathology findings in a majority of infertile couples and, where they differ, a difference in findings does not lead to substantial difference in pregnancy outcome, while HyFoSy is associated with significantly less pain.
STUDY FUNDING/COMPETING INTEREST(S)


The FOAM study was an investigator-initiated study funded by ZonMw, The Netherlands organization for Health Research and Development (project number 837001504). ZonMw funded the whole project. IQ Medical Ventures provided the ExEm-foam® kits free of charge. The funders had no role in study design, collection, analysis and interpretation of the data. K.D. reports travel and speaker fees from Guerbet. F.J.M.B. reports personal fees as a member of the external advisory board for Merck Serono, The Netherlands, and a research support grant from Merck Serono, outside the submitted work. C.B.L. reports speakers' fee from Ferring in the past, and his department receives research grants from Ferring, Merck and Guerbet. J.S. reports a research agreement with Takeda on MR of motility outside the submitted work. M.V.W. reports leading The Netherlands Satellite of the Cochrane Gynaecology and Fertility Group. B.W.J.M. is supported by an NHMRC Investigator grant (GNT1176437). B.W.J.M. reports consultancy for Guerbet and research funding from Merck and Guerbet. V.M. reports non-financial support from IQ medicals ventures, during the conduct of the study; grants and personal fees from Guerbet, outside the submitted work. The other authors do not report conflicts of interest.
TRIAL REGISTRATION NUMBER


NTR4746/NL4587 (https://www.trialregister.nl).
TRIAL REGISTRATION DATE


19 August 2014.
DATE OF FIRST PATIENT’S ENROLMENT


7 May 2015.",2022,"The mean pain score for HyFoSy on the 1-10 Visual Analogue Scale (VAS) was 3.1 (SD 2.2) and the mean VAS pain score for HSG was 5.4 (SD 2.5; P for difference < 0.001).
","['26 hospitals in The Netherlands', 'infertile women between 18 and 41 years old who were scheduled for tubal patency testing during their fertility work-up', 'Between May 2015 and January 2019, 1026 women underwent', '19 August 2014', 'Participating women underwent both', 'Women with anovulatory cycles not responding to ovulation induction, endometriosis, severe male infertility or a known iodine contrast allergy were excluded', 'infertile couples']","['management strategy based on HyFoSy or one based on HSG', 'HyFoSy or HSG', 'hysterosalpingography (HSG', 'HyFoSy and HSG', 'HyFoSy', 'hysterosalpingo-foam sonography (HyFoSy']","['mean VAS pain score for HSG', 'HSG', 'Visual Analogue Scale (VAS', 'HyFoSy', 'mean pain score', 'HyFoSy- and HSG-based strategies was ongoing pregnancy leading to live birth']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0429468', 'cui_str': 'Anovulatory'}, {'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021364', 'cui_str': 'Male infertility'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]",1026.0,0.0734798,"The mean pain score for HyFoSy on the 1-10 Visual Analogue Scale (VAS) was 3.1 (SD 2.2) and the mean VAS pain score for HSG was 5.4 (SD 2.5; P for difference < 0.001).
","[{'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'van Welie', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Joukje', 'Initials': 'J', 'LastName': 'van Rijswijk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dreyer', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Machiel H A', 'Initials': 'MHA', 'LastName': 'van Hooff', 'Affiliation': 'Department of Obstetrics and Gynaecology, Franciscus Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan Peter de', 'Initials': 'JP', 'LastName': 'Bruin', 'Affiliation': 'Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, Den Bosch, The Netherlands.'}, {'ForeName': 'Harold R', 'Initials': 'HR', 'LastName': 'Verhoeve', 'Affiliation': 'Department of Obstetrics and Gynaecology, OLVG Oost, Amsterdam, The Netherlands.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Mol', 'Affiliation': 'Centre for Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Wilhelmina M', 'Initials': 'WM', 'LastName': 'van Baal', 'Affiliation': 'Department of Obstetrics and Gynaecology, Flevo Hospital, Almere, The Netherlands.'}, {'ForeName': 'Maaike A F', 'Initials': 'MAF', 'LastName': 'Traas', 'Affiliation': 'Department of Obstetrics and Gynaecology, Gelre Hospitals, Location Apeldoorn, Apeldoorn, The Netherlands.'}, {'ForeName': 'Arno M', 'Initials': 'AM', 'LastName': 'van Peperstraten', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rivierenland Hospital, Tiel, The Netherlands.'}, {'ForeName': 'Arentje P', 'Initials': 'AP', 'LastName': 'Manger', 'Affiliation': 'Department of Obstetrics and Gynaecology, Diakonessenhuis, Utrecht, The Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gianotten', 'Affiliation': 'Department of Obstetrics and Gynaecology, Spaarne Gasthuis, Haarlem, The Netherlands.'}, {'ForeName': 'Cornelia H', 'Initials': 'CH', 'LastName': 'de Koning', 'Affiliation': 'Department of Obstetrics and Gynaecology, Tergooi Hospital, Blaricum, The Netherlands.'}, {'ForeName': 'Aafke M H', 'Initials': 'AMH', 'LastName': 'Koning', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amstelland Hospital, Amstelveen, The Netherlands.'}, {'ForeName': 'Neriman', 'Initials': 'N', 'LastName': 'Bayram', 'Affiliation': 'Department of Obstetrics and Gynaecology, Zaans Medical Centre, Zaandam, The Netherlands.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'van der Ham', 'Affiliation': 'Department of Obstetrics and Gynaecology, Martini Hospital Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Francisca P J M', 'Initials': 'FPJM', 'LastName': 'Vrouenraets', 'Affiliation': 'Department of Obstetrics and Gynecology, Zuyderland Medical Center, Heerlen, The Netherlands.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Kalafusova', 'Affiliation': 'Department of Obstetrics and Gynaecology, Refaja Hospital, Stadskanaal, The Netherlands.'}, {'ForeName': 'Bob I G', 'Initials': 'BIG', 'LastName': 'van de Laar', 'Affiliation': 'Department of Obstetrics and Gynaecology, OLVG West, Amsterdam, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Kaijser', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ikazia Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Arjon F', 'Initials': 'AF', 'LastName': 'Lambeek', 'Affiliation': 'Department of Obstetrics and Gynaecology, IJsselland Hospital, Capelle aan den IJssel, The Netherlands.'}, {'ForeName': 'Wouter J', 'Initials': 'WJ', 'LastName': 'Meijer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Gelre Hospitals, Location Zutphen, Zutphen, The Netherlands.'}, {'ForeName': 'Frank J M', 'Initials': 'FJM', 'LastName': 'Broekmans', 'Affiliation': 'Department of Reproductive Medicine and Gynaecology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Valkenburg', 'Affiliation': 'Department of Reproductive Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Lucy F', 'Initials': 'LF', 'LastName': 'van der Voet', 'Affiliation': 'Department of Obstetrics and Gynaecology, Deventer Hospital, Deventer, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'van Disseldorp', 'Affiliation': 'Department of Obstetrics and Gynaecology, Sint Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Marieke J', 'Initials': 'MJ', 'LastName': 'Lambers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Dijklander Hospital, Hoorn, The Netherlands.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Tros', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Cornelis B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Stoker', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Madelon', 'Initials': 'M', 'LastName': 'van Wely', 'Affiliation': 'Centre for Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Patrick M M', 'Initials': 'PMM', 'LastName': 'Bossuyt', 'Affiliation': 'Department of Epidemiology & Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ben Willem J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, VIC, Australia.'}, {'ForeName': 'Velja', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deac034']
2480,35220371,Left Ventricular Adaptation to Exercise Training via MRI: Studies of Twin Responses to Understand Exercise THerapy (STRUETH).,"PURPOSE


Changes in left ventricular mass (LVM) and end-diastolic volume (EDV) in response to exercise training are important determinants of functional capacity in health and disease, but the impact of different exercise modalities remains unclear.
METHODS


Using a randomised cross-over design we studied the impact of resistance (RES) and endurance (END) training using cardiac magnetic resonance imaging in previously untrained monozygotic (MZ) and dizygotic (DZ) twin pairs (n = 72; 22MZ pairs, 14DZ same-sex pairs; 26.1 ± 5.4 yr). Twins, as pairs, undertook 3 months of RES and 3 months of END training (order randomised), separated by a 3 month washout.
RESULTS


Group results revealed that END increased LVM (P < 0.001) and EDV (P = 0.007), whilst RES did not (P > 0.05). A higher proportion of individuals responded to END than RES for LVM (72 vs 38%, P < 0.001) and EDV (67 vs 40%, P = 0.003). Baseline cross-sectional intra-class correlations were higher for MZ than DZ twin pairs for all variables (e.g. LVM heritability = 0.42), but no significant correlations were apparent between pairs for change in any variable in response to either RES or END (P > 0.05).
CONCLUSIONS


Our findings indicate that cardiac adaptation in response to exercise is modality-specific and that low responders to one mode of exercise can be high responders to an alternative. Heritability estimates based on cross-sectional data, which suggested a genetic contribution to LVM, do not accord with estimates based on training effects, which indicated limited genetic impact on adaptation in this 3 month study of exercise training. This study has implications for understanding the physiological and health impacts of typically used exercise modalities on cardiac adaptation in previously untrained individuals.",2022,"A higher proportion of individuals responded to END than RES for LVM (72 vs 38%, P < 0.001) and EDV (67 vs 40%, P = 0.003).","['previously untrained individuals', 'previously untrained monozygotic (MZ) and dizygotic (DZ) twin pairs (n = 72; 22MZ pairs, 14DZ same-sex pairs; 26.1 ± 5.4 yr']","['resistance (RES) and endurance (END) training using cardiac magnetic resonance imaging', 'exercise training']","['Baseline cross-sectional intra-class correlations', 'EDV', 'LVM']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041429', 'cui_str': 'Fraternal twin'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C4517792', 'cui_str': '5.4'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}]",,0.0135768,"A higher proportion of individuals responded to END than RES for LVM (72 vs 38%, P < 0.001) and EDV (67 vs 40%, P = 0.003).","[{'ForeName': 'Channa E', 'Initials': 'CE', 'LastName': 'Marsh', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA, AUSTRALIA Envision Medical Imaging, Wembley, Perth, WA, AUSTRALIA Advanced Heart Failure Unit and Cardiac Transplant Service of Western Australia, Fiona Stanley Hospital, Murdoch, WA, AUSTRALIA Twins Research Australia, Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Victoria, AUSTRALIA.'}, {'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': ''}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Dembo', 'Affiliation': ''}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Scurrah', 'Affiliation': ''}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002899']
2481,35220359,The Relationship Between Depression and Pain During Acute Electroconvulsive Therapy and Follow-Up Period for Patients With Treatment-Resistant Depression.,"OBJECTIVES


We explored the relationships between depression and pain during acute electroconvulsive therapy (ECT) and the follow-up period for patients with treatment-resistant depression and concomitant pain.
METHODS


During the acute ECT phase, treatment-resistant depression patients (N = 97) were randomized to receive ECT plus agomelatine 50 mg/d, or ECT plus placebo. Depression and pain severities were measured using the 17-item Hamilton Depression Rating Scale (HAMD-17), and the pain subscale of the Depression and Somatic Symptoms Scale at baseline, after every 3 ECT treatments, and after acute ECT. If patients achieved response (ie, a ≥ 50% reduction in HAMD-17) or received at least 6 ECT treatments, they were prescribed agomelatine 50 mg/d and participated in a 12-week follow-up trial. The HAMD-17 and pain subscale were assessed at 4-week intervals. Both HAMD-17 and pain subscale scores were converted to T score units to compare the degrees of changes between depression and pain during acute ECT and the follow-up period.
RESULTS


Eighty-two patients completing at least the first 3 ECT treatments entered the analysis. Both HAMD-17 and pain subscale decreased significantly after acute ECT. Changes of HAMD-17 T scores were significantly greater than changes of pain subscale T scores during acute ECT and follow-up period.
CONCLUSIONS


Pain changed more slowly than did depression while measuring both during acute ECT and the follow-up period. Pain can, therefore, be considered a separate entity from depression.",2022,"Changes of HAMD-17 T scores were significantly greater than changes of pain subscale T scores during acute ECT and follow-up period.
","['Patients With Treatment-Resistant Depression', 'resistant depression patients (N = 97', 'patients with treatment-resistant depression and concomitant pain']","['acute electroconvulsive therapy (ECT', 'ECT plus placebo', 'ECT plus agomelatine']","['HAMD-17 T scores', 'Depression and pain severities', 'pain subscale T scores', '17-item Hamilton Depression Rating Scale (HAMD-17), and the pain subscale of the Depression and Somatic Symptoms Scale', 'Both HAMD-17 and pain subscale scores', 'HAMD-17 and pain subscale', 'Depression and Pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0971637', 'cui_str': 'agomelatine'}]","[{'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",97.0,0.0991792,"Changes of HAMD-17 T scores were significantly greater than changes of pain subscale T scores during acute ECT and follow-up period.
","[{'ForeName': 'Ching-Hua', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'From the Kaohsiung Municipal Kai-Syuan Psychiatric Hospital Department of Psychiatry, School of Medicine, College of Medicine, Kaohsiung Medical University Department of Anesthesiology, Kaohsiung Municipal Min-Sheng Hospital Department of Business Management, National Sun Yat-Sen University, Kaohsiung, Taiwan.'}, {'ForeName': 'Wei-Cheng', 'Initials': 'WC', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Min-Ho', 'Initials': 'MH', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Cheng-Chung', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': ''}]",The journal of ECT,['10.1097/YCT.0000000000000830']
2482,35220356,Simulated Electroconvulsive Therapy: A Novel Approach to a Control Group in Clinical Trials.,"OBJECTIVES


Agitation is the most common behavioral symptom of Alzheimer disease (AD) affecting approximately 40% to 60% of the AD population, yet there are no Food and Drug Administration-approved therapies for the myriad of behavioral or psychological symptoms of dementia. There is growing evidence from naturalistic studies that electroconvulsive therapy (ECT) is a safe and effective treatment for agitation in AD patients who are refractory to pharmacotherapy and behavioral interventions. Despite the existing evidence, ECT remains underused because of stigma, lack of education, and concerns regarding adverse cognitive effects. Randomized controlled clinical trials of ECT are an opportunity to provide high-quality evidence of ECT as a safe and efficacious treatment for agitation in the AD population. We describe the methods for the Electroconvulsive Therapy in Alzheimer's Dementia study, which uses a novel, simulated ECT (S-ECT) control group to conduct a single-blind efficacy study of ECT for the treatment of agitation and aggression in individuals with moderate to severe AD.
METHODS


We discuss the rationale, study design, methodology, ethical and practical challenges, and management strategies in using an S-ECT group as the comparator arm in this randomized controlled trial of ECT in AD-related treatment refractory agitation and aggression.
CONCLUSIONS


Validation of the safety and efficacy of ECT in patients with advanced AD with refractory agitation and aggression is necessary. This can be accomplished through creative formulation of S-ECT groups that effectively maintain the blind while providing scientific integrity.",2022,There is growing evidence from naturalistic studies that electroconvulsive therapy (ECT) is a safe and effective treatment for agitation in AD patients who are refractory to pharmacotherapy and behavioral interventions.,"['patients with advanced AD', 'AD patients who are refractory to pharmacotherapy and behavioral interventions', 'individuals with moderate to severe AD', ""Alzheimer's Dementia study""]","['Electroconvulsive Therapy', 'electroconvulsive therapy (ECT', 'ECT', 'Simulated Electroconvulsive Therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}]",[],,0.283216,There is growing evidence from naturalistic studies that electroconvulsive therapy (ECT) is a safe and effective treatment for agitation in AD patients who are refractory to pharmacotherapy and behavioral interventions.,"[{'ForeName': 'Kaitlin R', 'Initials': 'KR', 'LastName': 'McManus', 'Affiliation': 'From the Division of Geriatric Psychiatry, McLean Hospital, Belmont, MA Mayo Clinic, Rochester, MN Harvard Medical School, Boston, MA Medical University of South Carolina, Charleston, SC Emory University School of Medicine, Atlanta, GA Pine Rest Christian Mental Health Services, Grand Rapids, MI The Zucker Hillside Hospital, Northwell Health, Glen Oaks Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Lapid', 'Affiliation': ''}, {'ForeName': 'Brent P', 'Initials': 'BP', 'LastName': 'Forester', 'Affiliation': ''}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': ''}, {'ForeName': 'Adriana P', 'Initials': 'AP', 'LastName': 'Hermida', 'Affiliation': ''}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Nykamp', 'Affiliation': ''}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Harper', 'Affiliation': ''}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Seiner', 'Affiliation': ''}, {'ForeName': 'Sohag', 'Initials': 'S', 'LastName': 'Sanghani', 'Affiliation': ''}, {'ForeName': 'Regan', 'Initials': 'R', 'LastName': 'Patrick', 'Affiliation': ''}, {'ForeName': 'Melanie T', 'Initials': 'MT', 'LastName': 'Gentry', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kung', 'Affiliation': ''}, {'ForeName': 'Janette C', 'Initials': 'JC', 'LastName': 'Leal', 'Affiliation': ''}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Petrides', 'Affiliation': ''}]",The journal of ECT,['10.1097/YCT.0000000000000832']
2483,35220340,Catabolism in Critical Illness: A Reanalysis of the REducing Deaths due to OXidative Stress (REDOXS) Trial.,"OBJECTIVES


Ongoing risk of death and poor functional outcomes are important consequences of prolonged critical illness. Characterizing the catabolic phenotype of prolonged critical illness could illuminate biological processes and inform strategies to attenuate catabolism. We aimed to examine if urea-to-creatinine ratio, a catabolic signature of prolonged critical illness, was associated with mortality after the first week of ICU stay.
DESIGN


Reanalysis of multicenter randomized trial of glutamine supplementation in critical illness (REducing Deaths due to OXidative Stress [REDOXS]).
SETTING


Multiple adult ICUs.
PATIENTS


Adult patients admitted to ICU with two or more organ failures related to their acute illness and surviving to day 7.
INTERVENTIONS


None.
MEASUREMENTS AND MAIN RESULTS


The association between time-varying urea-to-creatinine ratio and 30-day mortality was tested using Bayesian joint models adjusted for prespecified-covariates (age, kidney replacement therapy, baseline Sequential Organ Failure Assessment, dietary protein [g/kg/d], kidney dysfunction, and glutamine-randomization). From 1,021 patients surviving to day 7, 166 (16.3%) died by day 30. After adjustment in a joint model, a higher time-varying urea-to-creatinine ratio was associated with increased mortality (hazard ratio [HR], 2.15; 95% credible interval, 1.66-2.82, for a two-fold greater urea-to-creatinine ratio). This association persisted throughout the 30-day follow-up. Mediation analysis was performed to explore urea-to-creatinine ratio as a mediator-variable for the increased risk of death reported in REDOXS when randomized to glutamine, an exogenous nitrogen load. Urea-to-creatinine ratio closest to day 7 was estimated to mediate the risk of death associated with randomization to glutamine supplementation (HR, 1.20; 95% CI, 1.04-1.38; p = 0.014), with no evidence of a direct effect of glutamine (HR, 0.90; 95% CI, 0.62-1.30; p = 0.566).
CONCLUSIONS


The catabolic phenotype measured by increased urea-to-creatinine ratio is associated with increased risk of death during prolonged ICU stay and signals the deleterious effects of glutamine administration in the REDOXS study. Urea-to-creatinine ratio is a promising catabolic signature and potential interventional target.",2022,"After adjustment in a joint model, a higher time-varying urea-to-creatinine ratio was associated with increased mortality (hazard ratio [HR], 2.15; 95% credible interval, 1.66-2.82, for a two-fold greater urea-to-creatinine ratio).","['Multiple adult ICUs', 'Adult patients admitted to ICU with two or more organ failures related to their acute illness and surviving to day 7']",['glutamine supplementation'],"['time-varying urea-to-creatinine ratio and 30-day mortality', 'urea-to-creatinine ratio', 'Urea-to-creatinine ratio closest', 'mortality', 'kidney dysfunction, and glutamine-randomization', 'catabolic phenotype', 'higher time-varying urea-to-creatinine ratio']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0151746', 'cui_str': 'Abnormal renal function'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0205250', 'cui_str': 'High'}]",1021.0,0.358315,"After adjustment in a joint model, a higher time-varying urea-to-creatinine ratio was associated with increased mortality (hazard ratio [HR], 2.15; 95% credible interval, 1.66-2.82, for a two-fold greater urea-to-creatinine ratio).","[{'ForeName': 'Ryan W', 'Initials': 'RW', 'LastName': 'Haines', 'Affiliation': ""Adult Critical Care Unit, The Royal London Hospital, Barts Health NHS Trust, London, United Kingdom. William Harvey Research Institute, Queen Mary University of London, London, United Kingdom. Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada. Clinical Evaluation Research Unit, Kingston Health Science Center, Kingston, ON, Canada. Department of Renal Medicine and Transplantation, The Royal London Hospital, Barts Health NHS Trust, London, United Kingdom.""}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Fowler', 'Affiliation': ''}, {'ForeName': 'Yize I', 'Initials': 'YI', 'LastName': 'Wan', 'Affiliation': ''}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Flower', 'Affiliation': ''}, {'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Day', 'Affiliation': ''}, {'ForeName': 'Rupert M', 'Initials': 'RM', 'LastName': 'Pearse', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Prowle', 'Affiliation': ''}, {'ForeName': 'Zudin', 'Initials': 'Z', 'LastName': 'Puthucheary', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000005499']
2484,35211677,Barriers to Implementing Motivational Interviewing in Addiction Treatment: A Nominal Group Technique Process Evaluation.,"Background


The successful implementation of evidence-based practices (EBPs) in real-world settings requires an adaptive approach and ongoing process evaluation and tailoring. Although conducting a needs assessment during the preparation phase of implementation is beneficial, it is challenging to predict all barriers to EBP implementation that may arise over the course of implementation and sustainment. This article describes a process evaluation that identified emergent and persistent barriers that impacted the implementation of an EBP across multiple behavioral health organizations and clinics.
Methods


This study was conducted during the first cohort of a cluster randomized controlled trial testing the effectiveness of the Leadership and Organizational Change for Implementation (LOCI) strategy to implement motivational interviewing (MI) in substance use disorder treatment agencies and clinics. We used a modified nominal group technique (NGT) in which clinic leaders identified barriers faced during the implementation process. Barriers were categorized, then ranked and rated according to leaders' perceptions of each barrier's influence on implementation. The barriers were then contextualized through individual qualitative interviews.
Results


Fifteen barriers were identified, grouped into staff-level barriers, management-level barriers, and implementation program barriers. Time and resistance to MI were rated as the most influential staff-level barriers. Among management-level barriers, time was also rated highest, followed by turnover and external contractual constraints. The most influential implementation barrier was client apprehension of recording for fidelity assessment and feedback. Individual interviews supported these findings and provided suggested adaptations for future implementation efforts.
Conclusion


EBP implementation is an ongoing process whereby implementation strategies must be proactively and strategically tailored to address emergent barriers. This research described a process evaluation that was used to identify 15 emergent and/or persistent barriers related to staff, management, and the implementation program. Using implementation strategies that can be tailored and/or adapted to such emergent barriers is critical to implementation effectiveness.",2021,"This article describes a process evaluation that identified emergent and persistent barriers that impacted the implementation of an EBP across multiple behavioral health organizations and clinics.
",['substance use disorder treatment agencies and clinics'],"['Leadership and Organizational Change for Implementation (LOCI) strategy to implement motivational interviewing (MI', 'modified nominal group technique (NGT']",['Time and resistance to MI'],"[{'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0086739', 'cui_str': 'Organizational Change'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]",15.0,0.0211789,"This article describes a process evaluation that identified emergent and persistent barriers that impacted the implementation of an EBP across multiple behavioral health organizations and clinics.
","[{'ForeName': 'Mellissa R', 'Initials': 'MR', 'LastName': 'Hatch', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Carandang', 'Affiliation': 'Child and Adolescent Services Research Center, San Diego, CA, USA.'}, {'ForeName': 'Joanna C', 'Initials': 'JC', 'LastName': 'Moullin', 'Affiliation': 'Child and Adolescent Services Research Center, San Diego, CA, USA.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Ehrhart', 'Affiliation': 'Department of Psychology, University of Central Florida, Orlando, FL, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Aarons', 'Affiliation': 'Child and Adolescent Services Research Center, San Diego, CA, USA.'}]",Implementation research and practice,['10.1177/26334895211018400']
2485,35212278,A randomized controlled clinical study on Zuo's acupuncture treatment for prediabetes.,"INTRODUCTION


Prediabetes is a high-risk stage of transition to type 2 diabetes mellitus. Previous studies suggest that acupuncture has potential to prevent prediabetes' conversion to type 2 diabetes mellitus, which lack of high-quality evidence. Zuo's acupuncture, a kind of acupuncture technique, is formed through long-term and repeated clinical practice by professor Zuo Changbo who integrates the internal meaning of Dong extra acupoints and Taoist medicine principle according to the theories of traditional Chinese medicine. It is used clinically to increase the regression toward normo-glycemi on prediabetes. The objective of this trial is to clarify the clinical effectiveness and safety of Zuo acupuncture for prediabetes.
METHODS AND ANALYSIS


This study is a prospective randomized controlled trial in which 60 patients with prediabetes will be randomly allocated in a 1:1 ratio into either an acupuncture treatment group or a control group. Prediabetes patients in the control group will receive prediabetes health education for lifestyle interventions, whereas patients in the acupuncture group will receive lifestyle interventions plus Zuo Daliji and Yueku stitch treatment. Twenty-four treatment sessions will be performed over 3 months. The primary outcome is conversion rate from prediabetes to normal blood glucose. Secondary outcomes include fasting plasma glucose, 2-hour plasma glucose, glycosylated hemoglobin and blood lipid concentration.
ETHICS AND DISSEMINATION


This study was approved by the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (permission number: YF2020-107-01) and the protocol conforms to the principles of the Declaration of Helsinki. Data collection will be completed by June 2022. Publications will be ready for submission in July 2022.",2022,"Zuo's acupuncture, a kind of acupuncture technique, is formed through long-term and repeated clinical practice by professor Zuo Changbo who integrates the internal meaning of Dong extra acupoints and Taoist medicine principle according to the theories of traditional Chinese medicine.","['Guangdong Provincial Hospital of Chinese Medicine (permission number', 'prediabetes', '60 patients with prediabetes']","['acupuncture', 'Zuo acupuncture', ""Zuo's acupuncture"", 'prediabetes health education for lifestyle interventions', 'acupuncture group will receive lifestyle interventions plus Zuo Daliji and Yueku stitch treatment', 'acupuncture treatment group or a control group']","['conversion rate from prediabetes to normal blood glucose', 'fasting plasma glucose, 2-hour plasma glucose, glycosylated hemoglobin and blood lipid concentration']","[{'cui': 'C3661820', 'cui_str': 'Provincial hospital'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0521104', 'cui_str': 'With permission of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0580545', 'cui_str': 'Blood glucose normal'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",60.0,0.123623,"Zuo's acupuncture, a kind of acupuncture technique, is formed through long-term and repeated clinical practice by professor Zuo Changbo who integrates the internal meaning of Dong extra acupoints and Taoist medicine principle according to the theories of traditional Chinese medicine.","[{'ForeName': 'Xuanli', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'The Second Clinical Medical College, Guangzhou University of Chinese Medicine, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Clinical Research and Data Center, South China Research Center for Acupuncture and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wen', 'Affiliation': 'Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, China.'}, {'ForeName': 'Guorui', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'The Second Clinical Medical College, Guangzhou University of Chinese Medicine, China.'}, {'ForeName': 'Changbo', 'Initials': 'C', 'LastName': 'Zuo', 'Affiliation': 'Changbo Zuo International Acupuncture Research Center, Guangzhou University of Chinese Medicine, China.'}]",Medicine,['10.1097/MD.0000000000028824']
2486,35212274,"Clinical application of gelatin sponge microparticles-transcatheter arterial chemoembolization combined with synchronous antigen-presenting dendritic cell sequential reinfusion for treatment of advanced large liver cancer: A single-center, prospective, non-randomized, controlled trial.","ABSTRACT


To assess the clinical efficacy and safety of gelatin sponge microparticles-transcatheter arterial chemoembolization (GSMs-TACE) plus synchronous antigen-presenting dendritic cell (DC) sequential reinfusion for advanced large liver cancer (LC).Patients with large LC were assigned to the experimental (combined sequential DC therapy) or control group. All patients received standardized GSMs-TACE. In the experimental group, 60 mL of peripheral blood was collected for in vitro culture of DCs (10-14 days). Then, intravenous reinfusion was conducted 3 times within 10, 20, and 30 days after surgery. Adverse reactions during the treatment were recorded and evaluated. The overall survival, transcatheter arterial chemoembolization frequency, and physical score (PS) were calculated.The median survival time of the experimental group was significantly longer than that of the control group. There were significant differences in median progression-free survival between the 2 groups (P < .05) and the objective effective rate at 1 and 6 months and 1 year (P < .05), but not 2 years (P > .05). The PSs of 2 groups were significantly improved at 1 month after GSMs-TACE, with more obvious improvement in the experimental group (P < .05).GSMs-TACE plus synchronous DC sequential reinfusion significantly prolonged the median survival time, improved the tumor response rate and PS, prolonged progression-free survival, and reduced intervention frequency. GSMs-TACE plus synchronous DC sequential reinfusion treatment is suitable for comprehensive treatment of patients with advanced larger LC in China.",2022,"There were significant differences in median progression-free survival between the 2 groups (P < .05) and the objective effective rate at 1 and 6 months and 1 year (P < .05), but not 2 years (P > .05).","['advanced large liver cancer (LC).Patients with large LC', 'advanced large liver cancer', 'patients with advanced larger LC in China']","['gelatin sponge microparticles-transcatheter arterial chemoembolization (GSMs-TACE) plus synchronous antigen-presenting dendritic cell (DC) sequential reinfusion', 'standardized GSMs-TACE', 'gelatin sponge microparticles-transcatheter arterial chemoembolization combined with synchronous antigen-presenting dendritic cell sequential reinfusion']","['tumor response rate and PS, prolonged progression-free survival, and reduced intervention frequency', 'median progression-free survival', 'Adverse reactions', 'median survival time', 'objective effective rate', 'overall survival, transcatheter arterial chemoembolization frequency, and physical score (PS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0019209', 'cui_str': 'Large liver'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0032699', 'cui_str': 'Phylum Porifera'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0003315', 'cui_str': 'Immunologic Accessory Cells'}, {'cui': 'C0854643', 'cui_str': 'Reinfusion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}]",,0.0756756,"There were significant differences in median progression-free survival between the 2 groups (P < .05) and the objective effective rate at 1 and 6 months and 1 year (P < .05), but not 2 years (P > .05).","[{'ForeName': 'Guang Sheng', 'Initials': 'GS', 'LastName': 'Zhao', 'Affiliation': 'Interventional Medicine Center, Affiliated Zhongshan Hospital of Dalian University, No.6 Jie Fang Street, Dalian, Liaoning Province, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Interventional Medicine Center, Linyi Cancer Hospital, 6 East Lingyuan Street, Linyi, Shandong Province, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Hepatobiliary and Pancreatic Center, Beijing Tsinghua Changgung Hospital, 168 Litang Road, Changping District, Beijing, China.'}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Interventional Medicine Center, Affiliated Zhongshan Hospital of Dalian University, No.6 Jie Fang Street, Dalian, Liaoning Province, China.'}, {'ForeName': 'Ruo Yu', 'Initials': 'RY', 'LastName': 'Wang', 'Affiliation': 'Cancer Treatment Center, Affiliated Zhongshan Hospital of Dalian University, No.6 Jiefang Street, Dalian, Liaoning Province, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Bian', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Dalian Medical University, No.467 Zhongshan Road, Shahekou District, Dalian 116027, Liaoning Province, China.'}, {'ForeName': 'Rui Ping', 'Initials': 'RP', 'LastName': 'Zhu', 'Affiliation': 'Department of Pathology, Affiliated Zhongshan Hospital of Dalian University, No.6 Jie Fang Street, Dalian, Liaoning Province, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Interventional Medicine Center, Affiliated Zhongshan Hospital of Dalian University, No.6 Jie Fang Street, Dalian, Liaoning Province, China.'}, {'ForeName': 'Yue Wei', 'Initials': 'YW', 'LastName': 'Zhang', 'Affiliation': 'Hepatobiliary and Pancreatic Center, Beijing Tsinghua Changgung Hospital, 168 Litang Road, Changping District, Beijing, China.'}]",Medicine,['10.1097/MD.0000000000028803']
2487,35212167,Aerobic exercise training in older men and women-Cerebrovascular responses to submaximal exercise: Results from the Brain in Motion study.,"Physical inactivity is a leading modifiable risk factor for cardiovascular and cerebrovascular disease, cognitive dysfunction, and global mortality. Regular exercise might mitigate age-related declines in cardiovascular and cerebrovascular function. In this study, we hypothesize that a 6-month aerobic exercise intervention will lead to a decrease in cerebrovascular resistance index (CVRi) and to an increase in cerebral blood flow (CBF) and cerebrovascular conductance index (CVCi) during two submaximal exercise workloads (40% VO 2  max and 65 W), intensities that have been shown to be comparable to activities of daily life. Two hundred three low-active healthy men and women enrolled in the Brain in Motion study, completed a 6-month exercise intervention and underwent submaximal and maximal tests pre-/post-intervention. The intervention improved the gas exchange threshold and maximal oxygen consumption (VO 2  max), with no change in heart rate at VO 2  max, during the treadmill VO 2  max test. Heart rate and CVRi decreased from pre-intervention values during both relative (40% VO 2  max) and absolute (65 W) submaximal exercise tests. Blood flow velocity in the middle cerebral artery and CVCi increased post-intervention during 40% VO 2  max and 65 W. Changes in mean arterial pressure were found only during the absolute component (65 W). Our study demonstrates that aerobic exercise improves not only cardiorespiratory indices but also cerebrovascular function at submaximal workloads which may help to mitigate age-related declines in everyday life. Investigation of the mechanisms underlying the decline in cardiovascular and cerebrovascular capacity with aging has important implications for the maintenance of health and continued independence of older adults.",2022,"The intervention improved the gas exchange threshold and maximal oxygen consumption (VO 2  max), with no change in heart rate at VO 2  max, during the treadmill VO 2  max test.","['Two hundred three low-active healthy men and women enrolled in the Brain in Motion study, completed a 6-month', 'older men and women-Cerebrovascular responses to submaximal exercise', 'older adults']","['exercise intervention and underwent submaximal and maximal tests pre-/post-intervention', 'aerobic exercise intervention', 'Aerobic exercise training', 'Regular exercise', 'aerobic exercise']","['Blood flow velocity', 'heart rate', 'Heart rate and CVRi', 'mean arterial pressure', 'cerebral blood flow (CBF) and cerebrovascular conductance index (CVCi', 'gas exchange threshold and maximal oxygen consumption (VO 2  max', 'cerebrovascular resistance index (CVRi']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}]","[{'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",203.0,0.023536,"The intervention improved the gas exchange threshold and maximal oxygen consumption (VO 2  max), with no change in heart rate at VO 2  max, during the treadmill VO 2  max test.","[{'ForeName': 'Sonja L', 'Initials': 'SL', 'LastName': 'Lake', 'Affiliation': 'Department of Physiology and Pharmacology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Guadagni', 'Affiliation': 'Department of Physiology and Pharmacology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Kendall', 'Affiliation': 'Department of Physiology and Pharmacology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Chadder', 'Affiliation': 'Department of Physiology and Pharmacology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Anderson', 'Affiliation': 'Department of Cardiac Sciences, Libin Cardiovascular Institute of Alberta, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Leigh', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Rawling', 'Affiliation': 'Department of Family Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Hogan', 'Affiliation': 'Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Poulin', 'Affiliation': 'Department of Physiology and Pharmacology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}]",Physiological reports,['10.14814/phy2.15158']
2488,34860207,The Mindful Lawyer: Investigating the Effects of Two Online Mindfulness Programs on Self-Reported Well-Being in the Legal Profession.,"OBJECTIVES


Two studies were conducted to determine whether mindfulness meditation could be an effective tool for improving well-being among legal professionals-a population plagued by high rates of depression, anxiety, and stress.
METHODS


Study 1. Legal professionals completed questionnaires before and after an 8-week mindfulness program. Study 2. Lawyers were randomly assigned to either an experimental or waitlist condition. Questionnaires were administered at the beginning of the study and after experimental participants had completed a 30-day intervention.
RESULTS


Study 1. Participants reported significant improvements in mood, resilience, trait mindfulness, stress, anxiety, and depression over time. Study 2. Post-intervention, experimental participants reported better mood, lower levels of stress, and higher levels of non-reactivity and observing than waitlist participants.
CONCLUSIONS


Mindfulness and meditation may effectively improve well-being among legal professionals.",2021,"Post-intervention, experimental participants reported better mood, lower levels of stress, and higher levels of non-reactivity and observing than waitlist participants.
",[],"['mindfulness meditation', 'Two Online Mindfulness Programs']","['better mood, lower levels of stress, and higher levels of non-reactivity', 'mood, resilience, trait mindfulness, stress, anxiety, and depression over time']",[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0647356,"Post-intervention, experimental participants reported better mood, lower levels of stress, and higher levels of non-reactivity and observing than waitlist participants.
","[{'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'Nielsen', 'Affiliation': 'Department of Psychology & The Brain and Mind Institute, Western University, London, Ontario, Canada.'}, {'ForeName': 'John Paul', 'Initials': 'JP', 'LastName': 'Minda', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000002393']
2489,34856618,Glycemic Control and Aspirin Resistance in Patients Taking Low-Dose Aspirin for Pre-eclampsia Prevention.,"OBJECTIVES


To assess the association between aspirin and glycemic control in diabetic, pregnant patients, and the risk for aspirin resistance in those with poor glycemic control across gestation taking low-dose aspirin (LDA) for pre-eclampsia (PEC) prevention.
STUDY DESIGN


We performed a secondary analysis of samples collected during the Maternal-Fetal Medicine Units trial of LDA for PEC prevention. A subset of insulin-controlled diabetic patient samples on placebo or 60 mg aspirin daily were evaluated. Glycosylated hemoglobin was measured at randomization, mid-second trimester, and third trimester time points. Thromboxane B 2  (TXB 2 ) measurements were previously assessed as part of the original study. Primary outcome was the effect of LDA on glycosylated hemoglobin levels compared with placebo across gestation.
RESULTS


Levels of glycosylated hemoglobin increased across gestation in the placebo group (2,067.7 [interquartile range, IQR: 1,624.6-2,713.5 µg/mL] vs. 2,461.9 [1,767.0-3,209.9 µg/mL] vs. 3,244.3 [2,691.5-4,187.0 µg/mL];  p  < 0.01) compared with no difference in levels of glycosylated hemoglobin across gestation in the LDA group (2,186.4 [IQR: 1,462.3-3,097.7 µg/mL] vs. 2,337.1 [1,327.7-5,932.6 µg/mL] vs. 2,532.9 [1,804.9-5,511.8 µg/mL];  p  = 0.78). Higher levels of glycosylated hemoglobin were associated with increased TXB 2  levels prior to randomization ( r  = 0.67,  p  < 0.05). Incomplete TXB 2  was higher in pregnancies with increasing levels of glycosylated hemoglobin compared with those with decreasing levels of glycosylated hemoglobin across gestation (69.2 vs. 18.1%,  p  = 0.02).
CONCLUSION


LDA exposure may be beneficial to glycemic control in this patient population. Additionally, poor glycemic control is associated with a higher level of TXB 2  in diabetic pregnant patients on LDA. Higher doses of aspirin may be required in these patients to prevent development of PEC.
KEY POINTS


· Low-dose aspirin may improve glycemic control.. · Poor glycemic control increases risk for aspirin resistance.. · Higher doses of aspirin may be required for pre-eclampsia prevention..",2022,"Higher levels of glycosylated hemoglobin were associated with increased TXB 2  levels prior to randomization ( r  = 0.67,  p  < 0.05).","['Patients Taking Low-Dose Aspirin for Pre-eclampsia Prevention', 'diabetic pregnant patients on LDA', 'diabetic, pregnant patients, and the risk for aspirin resistance in those with poor glycemic control across gestation taking low-dose']","['placebo', 'aspirin', 'Thromboxane', 'LDA', 'aspirin (LDA']","['glycosylated hemoglobin across gestation', 'glycosylated hemoglobin', 'glycosylated hemoglobin levels', 'Glycosylated hemoglobin', 'Glycemic Control and Aspirin Resistance', 'glycemic control', 'levels of glycosylated hemoglobin across gestation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0040061', 'cui_str': 'Thromboxane'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}]",,0.0800829,"Higher levels of glycosylated hemoglobin were associated with increased TXB 2  levels prior to randomization ( r  = 0.67,  p  < 0.05).","[{'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Gee', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': ""Ma'ayeh"", 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Kniss', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Landon', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Gabbe', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Kara M', 'Initials': 'KM', 'LastName': 'Rood', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.'}]",American journal of perinatology,['10.1055/s-0041-1740250']
2490,35213594,Does attention bias modification reduce anxiety in socially anxious college students? An experimental study of potential moderators and considerations for implementation.,"According to cognitive models, preferential attention to social threat contributes to maintenance of social anxiety. Socially anxious individuals are known to show attention biases to threatening stimuli, although there is inconsistency in the literature with regards to the type of attentional biases they present. This study examines the effect of attention bias modification (ABM) for social anxiety in non-treatment-seeking college students meeting social anxiety disorder criteria, taking into consideration previous mixed results regarding its effectiveness. Attention bias levels and types (i.e. vigilance vs avoidance) at baseline were examined and considered as potential moderators of ABM effects. Sixty-eight socially anxious individuals were randomly allocated to ABM vs placebo groups. A structured interview and self-report assessment were completed at pre-treatment and post-treatment. Results showed half of the participants presented few attention biases at baseline, and the rest presented either vigilance or avoidance. Participants with low attention biases scored higher in social anxiety than those showing avoidance and there was no difference between those showing vigilance vs avoidance. No significant effects from pre to post treatment were observed in attention biases, self-report or structured interview of anxiety in the ABM group. Baseline attention biases did not moderate these effects. Results are discussed with regards to implications for future research towards the creation of more effective protocols, based on the needs of heterogeneous social anxiety sub-groups.",2022,"No significant effects from pre to post treatment were observed in attention biases, self-report or structured interview of anxiety in the ABM group.","['socially anxious college students', 'Socially anxious individuals', 'Sixty-eight socially anxious individuals', 'non-treatment-seeking college students meeting social anxiety disorder criteria']","['ABM vs placebo', 'attention bias modification (ABM']","['attention biases, self-report or structured interview of anxiety', 'social anxiety']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}]",68.0,0.0284167,"No significant effects from pre to post treatment were observed in attention biases, self-report or structured interview of anxiety in the ABM group.","[{'ForeName': 'Klavdia', 'Initials': 'K', 'LastName': 'Neophytou', 'Affiliation': 'Department of Psychology, University of Cyprus, Nicosia, Cyprus.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Panayiotou', 'Affiliation': 'Department of Psychology, University of Cyprus, Nicosia, Cyprus.'}]",PloS one,['10.1371/journal.pone.0264256']
2491,35213554,Updated cost-effectiveness of MDMA-assisted therapy for the treatment of posttraumatic stress disorder in the United States: Findings from a phase 3 trial.,"BACKGROUND


Severe posttraumatic stress disorder (PTSD) is a prevalent and debilitating condition in the United States. and globally. Using pooled efficacy data from six phase 2 trials, therapy using 3,4-methylenedioxymethamphetamine (MDMA) appeared cost-saving from a payer's perspective. This study updates the cost-effectiveness analysis of this novel therapy using data from a new phase 3 trial, including the incremental cost-effectiveness of the more intensive phase 3 regimen compared with the shorter phase 2 regimen.
METHODS


We adapted a previously-published Markov model to portray the costs and health benefits of providing MDMA-assisted therapy (MDMA-AT) to patients with chronic, severe, or extreme PTSD in a recent phase 3 trial, compared with standard care. Inputs were based on trial results and published literature. The trial treated 90 patients with a clinician administered PTSD scale (CAPS-5) total severity score of 35 or greater at baseline, and duration of PTSD symptoms of 6 months or longer. The primary outcome was assessed 8 weeks after the final experimental session. Patients received three 90-minute preparatory psychotherapy sessions, three 8-hour active MDMA or placebo sessions, and nine 90-minute integrative psychotherapy sessions. Our model calculates the per-patient cost of MDMA-AT, net all-cause medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). We reported results from the U.S. health care payer's perspective for multiple analytic time horizons, (base-case is 30 years), and conducted extensive sensitivity analyses. Costs and QALYs were discounted by 3% annually. Costs were adjusted to 2020 U.S. dollars according to the medical component of the U.S. Bureau of Labor Statistics' Consumer Price Index (CPI).
RESULTS


MDMA-AT as conducted in the phase 3 trial costs $11,537 per patient. Compared to standard of care for 1,000 patients, MDMA-AT generates discounted net health care savings of $132.9 million over 30 years, accruing 4,856 QALYs, and averting 61.4 premature deaths. MDMA-AT breaks even on cost at 3.8 years while delivering 887 QALYs. A third MDMA session generates additional medical savings and health benefits compared with a two-session regimen. Hypothetically assuming no savings in health care costs, MDMA-AT has an ICER of $2,384 per QALY gained.
CONCLUSIONS


MDMA-AT provided to patients with severe or extreme chronic PTSD is cost-saving from a payer's perspective, while delivering substantial clinical benefit.",2022,"Hypothetically assuming no savings in health care costs, MDMA-AT has an ICER of $2,384 per QALY gained.
","['Severe posttraumatic stress disorder (PTSD', 'posttraumatic stress disorder in the United States', '90 patients with a clinician administered PTSD scale (CAPS-5) total severity score of 35 or greater at baseline, and duration of PTSD symptoms of 6 months or longer', 'patients with severe or extreme chronic PTSD']","['MDMA-assisted therapy (MDMA-AT', 'preparatory psychotherapy sessions, three 8-hour active MDMA or placebo sessions, and nine 90-minute integrative psychotherapy sessions', '3,4-methylenedioxymethamphetamine (MDMA', 'MDMA-assisted therapy']","['medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'Costs and QALYs', 'health care savings']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}]","[{'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0582728', 'cui_str': 'Integrative psychotherapy'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]",90.0,0.0572131,"Hypothetically assuming no savings in health care costs, MDMA-AT has an ICER of $2,384 per QALY gained.
","[{'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Marseille', 'Affiliation': 'Global Initiative for Psychedelic Science Economics, University of California, Berkeley, CA, United States of America.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Mitchell', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kahn', 'Affiliation': 'University of California, San Francisco, CA, United States of America.'}]",PloS one,['10.1371/journal.pone.0263252']
2492,35213547,"Subcutaneous sarilumab for the treatment of hospitalized patients with moderate to severe COVID19 disease: A pragmatic, embedded randomized clinical trial.","IMPORTANCE AND OBJECTIVE


The aim of this pragmatic, embedded, adaptive trial was to measure the effectiveness of the subcutaneous anti-IL-6R antibody sarilumab, when added to an evolving standard of care (SOC), for clinical management of inpatients with moderate to severe COVID-19 disease.
DESIGN


Two-arm, randomized, open-label controlled trial comparing SOC alone to SOC plus sarilumab. The trial used a randomized play-the-winner design and was fully embedded within the electronic health record (EHR) system.
SETTING


5 VA Medical Centers.
PARTICIPANTS


Hospitalized patients with clinical criteria for moderate to severe COVID-19 but not requiring mechanical ventilation, and a diagnostic test positive for SARS-CoV-2.
INTERVENTIONS


Sarilumab, 200 or 400 mg subcutaneous injection. SOC was not pre-specified and could vary over time, e.g., to include antiviral or other anti-inflammatory drugs.
MAIN OUTCOMES AND MEASURES


The primary outcome was intubation or death within 14 days of randomization. All data were extracted remotely from the EHR.
RESULTS


Among 162 eligible patients, 53 consented, and 50 were evaluated for the primary endpoint of intubation or death. This occurred in 5/20 and 1/30 of participants in the sarilumab and SOC arms respectively, with the majority occurring in the initial 9 participants (3/4 in the sarilumab and 1/5 in the SOC) before the sarilumab dose was increased to 400 mg and before remdesivir and dexamethasone were widely adopted. After interim review, the unblinded Data Monitoring Committee recommended that the study be stopped due to concern for safety: a high probability that rates of intubation or death were higher with addition of sarilumab to SOC (92.6%), and a very low probability (3.4%) that sarilumab would be found to be superior.
CONCLUSIONS AND RELEVANCE


This randomized trial of patients hospitalized due to respiratory compromise from COVID-19 but not mechanical ventilation found no benefit from subcutaneous sarilumab when added to an evolving SOC. The numbers of patients and events were too low to allow definitive conclusions to be drawn, but this study contributes valuable information about the role of subcutaneous IL-6R inhibition in the treatment of hospitalized COVID-19 patients. Methods developed and piloted during this trial will be useful in conducting future studies more efficiently.
TRIAL REGISTRATION


Clinicaltrials.gov-NCT04359901; https://clinicaltrials.gov/ct2/show/NCT04359901?cond=NCT04359901&draw=2&rank=1.",2022,"This occurred in 5/20 and 1/30 of participants in the sarilumab and SOC arms respectively, with the majority occurring in the initial 9 participants (3/4 in the sarilumab and 1/5 in the SOC) before the sarilumab dose was increased to 400 mg and before remdesivir and dexamethasone were widely adopted.","['Hospitalized patients with clinical criteria for moderate to severe COVID-19 but not requiring mechanical ventilation, and a diagnostic test positive for SARS-CoV-2', 'inpatients with moderate to severe COVID-19 disease', 'patients hospitalized due to respiratory compromise from COVID-19 but not mechanical ventilation', '5 VA Medical Centers', 'hospitalized patients with moderate to severe COVID19 disease', '162 eligible patients, 53 consented, and 50']","['dexamethasone', 'Subcutaneous sarilumab', 'SOC alone to SOC plus sarilumab']","['intubation or death', 'rates of intubation or death']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",162.0,0.431585,"This occurred in 5/20 and 1/30 of participants in the sarilumab and SOC arms respectively, with the majority occurring in the initial 9 participants (3/4 in the sarilumab and 1/5 in the SOC) before the sarilumab dose was increased to 400 mg and before remdesivir and dexamethasone were widely adopted.","[{'ForeName': 'Westyn', 'Initials': 'W', 'LastName': 'Branch-Elliman', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Ferguson', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Gheorghe', 'Initials': 'G', 'LastName': 'Doros', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Woods', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Leatherman', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Strymish', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Rupak', 'Initials': 'R', 'LastName': 'Datta', 'Affiliation': 'Hospital Epidemiology and Infection Prevention Program, VA Connecticut Healthcare System, West Haven, Connecticut, United States of America.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Goswami', 'Affiliation': 'Section of Infectious Diseases, VA Maine Healthcare System, Togus, Maine, United States of America.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Jankowich', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Providence VA Medical Center, Alpert Medical School of Brown University, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Nishant R', 'Initials': 'NR', 'LastName': 'Shah', 'Affiliation': 'Division of Cardiology, Department of Medicine, Providence VA Medical Center, Alpert Medical School of Brown University, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Taylor', 'Affiliation': 'Infectious Diseases and Rheumatology, White River Jct. VA Medical Center, Hartford, Vermont, United States of America.'}, {'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Page', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Schiller', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Shannon', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Hau', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Visnaw', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Rupali', 'Initials': 'R', 'LastName': 'Dhond', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Brophy', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Monach', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts, United States of America.'}]",PloS one,['10.1371/journal.pone.0263591']
2493,35213517,Effects of E2/P4 oral capsules on bone turnover in women with vasomotor symptoms.,"OBJECTIVE


To evaluate bone turnover markers (BTM) in the REPLENISH trial (NCT01942668).
METHODS


REPLENISH evaluated oral estradiol/progesterone (E2/P4) for the treatment of moderate to severe vasomotor symptoms (VMS) in postmenopausal women with a uterus. Eligible women for this analysis had ≥50 moderate to severe VMS/wk, were <5 years since last menstrual period, and had BTM measurements at baseline, and months 6 and 12. Percent changes for three BTM (bone-specific alkaline phosphatase [BSAP], C-terminal telopeptide of type I collagen [CTX-1], and N-terminal propeptide of type I procollagen [P1NP]) assessed by immunoassay methods were evaluated from baseline to months 6 and 12 for the 1 mg E2/100 mg P4, 0.5 mg E2/100 mg P4, and placebo groups.
RESULTS


A total of 157 women (40-61 y, 69% White) were analyzed. Mean baseline values ranged from 14.0 to 14.3 U/L for BSAP, 0.34 to 0.39 ng/mL for CTX-1, and 76.9 to 79.3 ng/mL for PINP. Mean differences in percent change from baseline for both E2/P4 doses versus placebo significantly decreased at months 6 and 12 and ranged from -8% to -16% for BSAP (all, P < 0.05), -30% to -41% for CTX-1 (all, P ≤ 0.001), and -14% to -29% for PINP (all, P < 0.01).
CONCLUSIONS


REPLENISH data provide support for a potential skeletal benefit of E2/P4 when it is used for the treatment of moderate to severe VMS. Further studies are warranted.",2022,"Mean differences in percent change from baseline for both E2/P4 doses versus placebo significantly decreased at months 6 and 12 and ranged from -8% to -16% for BSAP (all, P < 0.05), -30% to -41% for CTX-1 (all, P ≤ 0.001), and -14% to -29% for PINP (all, P < 0.01).
","['A total of 157 women (40-61\u200ay, 69% White', 'moderate to severe vasomotor symptoms (VMS) in postmenopausal women with a uterus', 'Eligible women for this analysis had ≥50 moderate to severe VMS/wk, were <5\u200ayears since last menstrual period, and had BTM measurements at baseline, and months 6 and 12', 'women with vasomotor symptoms']","['I collagen', 'E2/P4 oral capsules', 'oral estradiol/progesterone (E2/P4', 'placebo']","['bone turnover', 'bone turnover markers (BTM']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0425932', 'cui_str': 'Date of last menstrual period'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0991533', 'cui_str': 'Oral capsule'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2243105', 'cui_str': 'Estradiol / Progesterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",157.0,0.0945625,"Mean differences in percent change from baseline for both E2/P4 doses versus placebo significantly decreased at months 6 and 12 and ranged from -8% to -16% for BSAP (all, P < 0.05), -30% to -41% for CTX-1 (all, P ≤ 0.001), and -14% to -29% for PINP (all, P < 0.01).
","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McClung', 'Affiliation': 'Oregon Osteoporosis Center, Portland, OR.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Kagan', 'Affiliation': 'University of California, San Francisco and Sutter East Bay Medical Foundation, Berkeley, CA.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Graham', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Constantine', 'Affiliation': 'EndoRheum Consultants, LLC, Malvern, PA.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001915']
2494,35215396,A Food-Based Intervention in a Military Dining Facility Improves Blood Fatty Acid Profile.,"Enhancing dietary omega-3 highly unsaturated fatty acids (n-3 HUFA) intake may confer neuroprotection, brain resiliency, improve wound healing and promote cardiovascular health. This study determined the efficacy of substituting a few common foods (chicken meat, chicken sausage, eggs, salad dressings, pasta sauces, cooking oil, mayonnaise, and peanut butter) lower in omega-6 polyunsaturated fatty acids (n-6 PUFA) and higher in n-3 HUFA in a dining facility on blood fatty acid profile. An eight-week prospective, between-subjects ( n  = 77), repeated measures, parallel-arm trial was conducted. Participants self-selected foods consumed from conventionally produced foods (control), or those lower n-6 PUFA and higher n-3 HUFA versions (intervention). Changes in blood omega-3 index, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), n-6 PUFA, lipid profile, and food satisfaction were main outcomes. Between-group differences over time were assessed using a linear mixed model to measure the effect of diet on blood serum fatty acids and inflammatory markers. The intervention group achieved a higher omega-3 index score (3.66 ± 0.71 vs. 2.95 ± 0.77;  p  < 0.05), lower total n-6 (10.1 ± 4.6 vs. 15.3 ± 6.7 µg/mL;  p  < 0.05), and higher serum concentration of EPA (5.0 ± 1.31 vs. 4.05 ± 1.56 µg/mL;  p  < 0.05) vs. controls. Satisfaction in intervention foods improved or remained consistent. Substitution of commonly eaten dining facility foods with like-items higher in DHA and EPA and lower in n-6 PUFA can favorably impact fatty acid status and the omega-3 index.",2022,"The intervention group achieved a higher omega-3 index score (3.66 ± 0.71 vs. 2.95 ± 0.77;  p  < 0.05), lower total n-6 (10.1 ± 4.6 vs. 15.3 ± 6.7 µg/mL;  p  < 0.05), and higher serum concentration of EPA (5.0 ± 1.31 vs. 4.05 ± 1.56 µg/mL;  p  < 0.05) vs. controls.","['Participants self-selected foods consumed from conventionally produced foods (control), or those lower n-6 PUFA and higher n-3 HUFA versions (intervention']","['Enhancing dietary omega-3 highly unsaturated fatty acids (n-3 HUFA', 'omega-6 polyunsaturated fatty acids (n-6 PUFA']","['Blood Fatty Acid Profile', 'higher omega-3 index score', 'blood omega-3 index, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), n-6 PUFA, lipid profile, and food satisfaction', 'blood serum fatty acids and inflammatory markers', 'lower total n-6', 'serum concentration of EPA']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.10953,"The intervention group achieved a higher omega-3 index score (3.66 ± 0.71 vs. 2.95 ± 0.77;  p  < 0.05), lower total n-6 (10.1 ± 4.6 vs. 15.3 ± 6.7 µg/mL;  p  < 0.05), and higher serum concentration of EPA (5.0 ± 1.31 vs. 4.05 ± 1.56 µg/mL;  p  < 0.05) vs. controls.","[{'ForeName': 'Asma S', 'Initials': 'AS', 'LastName': 'Bukhari', 'Affiliation': 'Military Nutrition Division of the US Army Research Institute of Environmental Medicine, Natick, MA 01760, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Lutz', 'Affiliation': 'Military Nutrition Division of the US Army Research Institute of Environmental Medicine, Natick, MA 01760, USA.'}, {'ForeName': 'Tracey J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'Military Nutrition Division of the US Army Research Institute of Environmental Medicine, Natick, MA 01760, USA.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Hatch-McChesney', 'Affiliation': 'Military Nutrition Division of the US Army Research Institute of Environmental Medicine, Natick, MA 01760, USA.'}, {'ForeName': 'Kristie L', 'Initials': 'KL', 'LastName': ""O'Connor"", 'Affiliation': 'Military Nutrition Division of the US Army Research Institute of Environmental Medicine, Natick, MA 01760, USA.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Carrigan', 'Affiliation': 'Military Nutrition Division of the US Army Research Institute of Environmental Medicine, Natick, MA 01760, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Hawes', 'Affiliation': 'Belovo Inc., Southern Pines, NC 28387, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'McGraw', 'Affiliation': 'Military Nutrition Division of the US Army Research Institute of Environmental Medicine, Natick, MA 01760, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Taylor', 'Affiliation': 'Military Performance Division of the US Army Research Institute of Environmental Medicine, Natick, MA 01760, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Champagne', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Montain', 'Affiliation': 'Military Nutrition Division of the US Army Research Institute of Environmental Medicine, Natick, MA 01760, USA.'}]",Nutrients,['10.3390/nu14040743']
2495,35215365,Effects of Ultramicronized Palmitoylethanolamide (um-PEA) in COVID-19 Early Stages: A Case-Control Study.,"Ultramicronized palmitoylethanolamide (um-PEA), a compound with antioxidant, anti-inflammatory and neuroprotective properties, appears to be a potential adjuvant treatment for early stages of Coronavirus disease 2019 (COVID-19). In our study, we enrolled 90 patients with confirmed diagnosis of COVID-19 that were randomized into two groups, homogeneous for age, gender and BMI. The first group received oral supplementation based on um-PEA at a dose of 1800 mg/day for a total of 28 days; the second group was the control group (R.S. 73.20). At baseline (T0) and after 28 days of um-PEA treatment (T1), we monitored: routine laboratory parameters, inflammatory and oxidative stress (OS) biomarkers, lymphocytes subpopulation and COVID-19 serological response. At T1, the um-PEA-treated group presented a significant reduction in inflammation compared to the control group (CRP  p  = 0.007; IL-6  p  = 0.0001; neutrophils to lymphocytes ratio  p  = 0.044). At T1, the controls showed a significant increase in OS compared to the treated group (FORT  p  = 0.05). At T1, the um-PEA group exhibited a significant decrease in D-dimer levels ( p  = 0.0001) and higher levels of IgG against SARS-CoV-2 ( p  = 0.0001) compared to the controls. Our data demonstrated, in a randomized clinical trial, the beneficial effects of um-PEA in both asymptomatic and mild-symptomatic patients related to reductions in inflammatory state, OS and coagulative cascade alterations.",2022,"At T1, the controls showed a significant increase in OS compared to the treated group (FORT  p  = 0.05).","['90 patients with confirmed diagnosis of COVID-19', 'COVID-19 Early Stages']","['Ultramicronized Palmitoylethanolamide (um-PEA', 'oral supplementation based on um-PEA', 'um-PEA', 'Ultramicronized palmitoylethanolamide (um-PEA']","['OS', 'routine laboratory parameters, inflammatory and oxidative stress (OS) biomarkers, lymphocytes subpopulation and COVID-19 serological response', 'inflammation', 'higher levels of IgG against SARS-CoV-2', 'inflammatory state, OS and coagulative cascade alterations', 'D-dimer levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0069964', 'cui_str': 'palmidrol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}]",90.0,0.0770561,"At T1, the controls showed a significant increase in OS compared to the treated group (FORT  p  = 0.05).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Albanese', 'Affiliation': 'Neurology Unit, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Marrone', 'Affiliation': 'UOC of Internal Medicine-Center of Hypertension and Nephrology Unit, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Paolino', 'Affiliation': 'Department of Biomedicine and Prevention, University of Rome Tor Vergata, 00133 Rome, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Di Lauro', 'Affiliation': 'UOC of Internal Medicine-Center of Hypertension and Nephrology Unit, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Di Daniele', 'Affiliation': 'PhD School of Applied Medical, Surgical Sciences, University of Rome Tor Vergata, 00133 Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Chiaramonte', 'Affiliation': 'Department of Statistics, University of Rome Tor Vergata, 00133 Rome, Italy.'}, {'ForeName': 'Cartesio', 'Initials': 'C', 'LastName': ""D'Agostini"", 'Affiliation': 'Department of Experimental Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Romani', 'Affiliation': 'PHYTOLAB (Pharmaceutical, Cosmetic, Food Supplement, Technology and Analysis), DiSIA, University of Florence, Sesto Fiorentino, 50019 Florence, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Cavaliere', 'Affiliation': 'Clinic Department of Gynecology Fabia Mater, 00171 Rome, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Guerriero', 'Affiliation': 'UOC of Internal Medicine-Center of Hypertension and Nephrology Unit, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Magrini', 'Affiliation': 'Department of Biomedicine and Prevention, University of Rome Tor Vergata, 00133 Rome, Italy.'}, {'ForeName': 'Nicola Biagio', 'Initials': 'NB', 'LastName': 'Mercuri', 'Affiliation': 'Neurology Unit, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Di Daniele', 'Affiliation': 'UOC of Internal Medicine-Center of Hypertension and Nephrology Unit, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Noce', 'Affiliation': 'UOC of Internal Medicine-Center of Hypertension and Nephrology Unit, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph15020253']
2496,35215349,Adverse Events during Vitreoretinal Surgery under Adequacy of Anesthesia Guidance-Risk Factor Analysis.,"Vitreoretinal surgeries require the administration of general anesthesia (GA) in selected groups of patients. The administration of intraoperative rescue narcotic analgesia (IRNA) during GA poses the risk of postoperative nausea and vomiting (PONV). The surgical pleth index (SPI), a crucial component of the adequacy of anesthesia (AoA) guidance of GA, optimizes the intraoperative titration of IRNA. The current analysis evaluated the risk factors for the occurrence of PONV and the oculo-cardiac reflex (OCR) in patients undergoing pars plana vitrectomy (PPV) under AoA guidance. In total, 175 patients undergoing PPV were randomly allocated to receive either GA with SPI-guided IRNA administration using fentanyl alone or in addition to different preoperative analgesia techniques. Any incidence of PONV or OCR was recorded. Obesity, overweight, smoking status, motion sickness, postoperative intolerable pain perception, female gender, fluid challenge and arterial hypertension did not correlate with an increased incidence of PONV or OCR under AoA guidance. Diabetes mellitus, regardless of insulin dependence, was found to correlate with the increased incidence of PONV. The AoA regimen including SPI guidance of IRNA presumably created similar conditions for individual subjects, so no risk factors of the occurrence of PONV or OCR were found, except for diabetes mellitus. We recommend using AoA guidance for GA administration to reduce OCR and PONV rates.",2022,The administration of intraoperative rescue narcotic analgesia (IRNA) during GA poses the risk of postoperative nausea and vomiting (PONV).,"['selected groups of patients', '175 patients undergoing PPV', 'patients undergoing pars plana vitrectomy (PPV) under AoA guidance']","['general anesthesia (GA', 'GA with SPI-guided IRNA administration using fentanyl alone or in addition to different preoperative analgesia techniques', 'intraoperative rescue narcotic analgesia (IRNA']","['surgical pleth index (SPI', 'PONV or OCR', 'Obesity, overweight, smoking status, motion sickness, postoperative intolerable pain perception, female gender, fluid challenge and arterial hypertension', 'OCR and PONV rates', 'postoperative nausea and vomiting (PONV']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0026603', 'cui_str': 'Motion sickness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",175.0,0.105917,The administration of intraoperative rescue narcotic analgesia (IRNA) during GA poses the risk of postoperative nausea and vomiting (PONV).,"[{'ForeName': 'Michał Jan', 'Initials': 'MJ', 'LastName': 'Stasiowski', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Pluta', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Lyssek-Boroń', 'Affiliation': 'Department of Ophthalmology with Paediatric Unit, 5th Regional Hospital, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Seweryn', 'Initials': 'S', 'LastName': 'Król', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, 5th Regional Hospital, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Lech', 'Initials': 'L', 'LastName': 'Krawczyk', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Niewiadomska', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health in Bytom, Medical University of Silesia, 41-902 Bytom, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Żak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Kawka', 'Affiliation': 'Department of Ophthalmology with Paediatric Unit, 5th Regional Hospital, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dobrowolski', 'Affiliation': 'Chair and Clinical Department of Ophthalmology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 40-760 Katowice, Poland.'}, {'ForeName': 'Beniamin Oskar', 'Initials': 'BO', 'LastName': 'Grabarek', 'Affiliation': 'Department of Histology, Cytophysiology and Embryology, Faculty of Medicine in Zabrze, University of Technology, Academy of Silesia in Katowice, 41-800 Zabrze, Poland.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Szumera', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Michael Janusz', 'Initials': 'MJ', 'LastName': 'Koss', 'Affiliation': 'Augenzentrum Nymphenburger Höfe, 80335 Munich, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Missir', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, 5th Regional Hospital, 41-200 Sosnowiec, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rejdak', 'Affiliation': 'Department of General Ophthalmology, Medical University of Lublin, 20-059 Lublin, Poland.'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Jałowiecki', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 41-200 Sosnowiec, Poland.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph15020237']
2497,35215313,"Efficacy, Safety and Patient-Reported Outcomes with Preservative-Free (PF) Tafluprost or PF-Dorzolamide/Timolol Compared with Preserved Latanoprost: A Prospective Multicenter Study in Korean Glaucoma Patients with Ocular Surface Disease.","To compare the efficacy, patient-reported satisfaction, and safety of preservative-free (PF)-tafluprost, PF-dorzolamide/timolol and preservative-containing (P)-latanoprost in Korean glaucoma patients with ocular surface disease (OSD). In a multicenter, prospective, interventional, non-randomized, controlled 12-week trial, 107 eligible patients received PF-tafluprost ( n  = 37), PF-dorzolamide/timolol ( n  = 34), or P-latanoprost eye drops ( n  = 36). Outcomes included changes from baseline in OSD Index (OSDI) scores (primary endpoint), intraocular pressure (IOP), and patient-reported treatment satisfaction, and safety at 12 weeks. At 12 weeks, the mean total OSDI and subdomain (dry eye symptoms, visual-related function, environmental triggers) scores significantly improved from baseline with PF-tafluprost and PF-dorzolamide/timolol, but not with P-latanoprost. Significantly more PF-tafluprost than P-latanoprost recipients reported 'highly improved/improved' satisfaction (no significant difference between PF-dorzolamide/timolol and P-latanoprost). IOP changes were comparable among all three treatment groups. No new safety concerns were observed. PF-tafluprost and PF-dorzolamide/timolol showed statistically and clinically significant reductions in OSDI compared with P-latanoprost in Korean glaucoma patients with OSD.",2022,Significantly more PF-tafluprost than P-latanoprost recipients reported 'highly improved/improved' satisfaction (no significant difference between PF-dorzolamide/timolol and P-latanoprost).,"['Korean glaucoma patients with OSD', '107 eligible patients received PF-tafluprost ( n  = 37', 'Korean glaucoma patients with ocular surface disease (OSD', 'Korean Glaucoma Patients with Ocular Surface Disease']","['Preservative-Free (PF) Tafluprost or PF-Dorzolamide', 'dorzolamide/timolol', 'PF-dorzolamide/timolol ( n  = 34), or P-latanoprost eye drops', 'Preserved Latanoprost', 'Timolol', 'preservative-free (PF)-tafluprost, PF-dorzolamide/timolol and preservative-containing (P)-latanoprost', 'PF-tafluprost and PF-dorzolamide/timolol', 'P-latanoprost']","['IOP changes', ' satisfaction', 'OSDI', 'OSD Index (OSDI) scores (primary endpoint), intraocular pressure (IOP), and patient-reported treatment satisfaction, and safety', 'Efficacy, Safety', 'mean total OSDI and subdomain (dry eye symptoms, visual-related function, environmental triggers) scores']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1451502', 'cui_str': 'tafluprost'}]","[{'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1451502', 'cui_str': 'tafluprost'}, {'cui': 'C0165590', 'cui_str': 'dorzolamide'}, {'cui': 'C1721343', 'cui_str': 'Dorzolamide- and timolol-containing product'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]",107.0,0.137666,Significantly more PF-tafluprost than P-latanoprost recipients reported 'highly improved/improved' satisfaction (no significant difference between PF-dorzolamide/timolol and P-latanoprost).,"[{'ForeName': 'Sang-Woo', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Chonnam National University Hospital, Gwangju 61469, Korea.'}, {'ForeName': 'Jiwoong', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Pusan National University Hospital, Busan 49241, Korea.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kook', 'Affiliation': 'Department of Ophthalmology, Asan Medical Center, Seoul 05505, Korea.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph15020201']
2498,35220312,"Effects of Melatonin and Propolis Supplementation on Inflammation, Oxidative Stress, and Clinical Outcomes in Patients with Primary Pneumosepsis: A Randomized Controlled Clinical Trial.","BACKGROUND & OBJECTIVE


The present study aimed to investigate the effects of propolis and melatonin supplementation on inflammation, clinical outcomes, and oxidative stress markers in patients with primary pneumosepsis.
MATERIALS AND METHODS


This pilot randomized controlled trial was conducted on 55 patients with primary pneumosepsis who were randomly assigned to the intervention and control groups. In the three intervention groups, the patients received propolis alone (1,000 mg/day), propolis (1,000 mg/day) plus melatonin (20 mg/day), and melatonin alone (20 mg/day). The control group received placebo. The inflammatory and oxidative stress markers as well as clinical outcomes were evaluated before and after the intervention, and the 28-day survival rate was also recorded.
RESULTS


After the intervention, the combination of propolis and melatonin significantly reduced interleukin-6 (-55.282 pg/ml ) and C-reactive protein (-21.656 mg/l ) levels, while increasing gavage intake (326.680 ml/day ) and improving some clinical outcomes (APACHE II, SOFA and NUTRIC scores) compared to control group. However, no significant difference was observed between the groups in terms of oxidative stress and hematological indices. In addition, the 28-day survival rate had no significant difference between the groups (P=0.07).
CONCLUSION


Supplementation with propolis and melatonin may improve clinical outcomes by reducing inflammation. Further investigations are required to confirm these findings.",2022,"In addition, the 28-day survival rate had no significant difference between the groups (P=0.07).
","['Patients with Primary Pneumosepsis', '55 patients with primary pneumosepsis', 'patients with primary pneumosepsis']","['melatonin alone', 'melatonin', 'placebo', 'propolis alone', 'Melatonin and Propolis Supplementation', 'propolis and melatonin supplementation', 'Supplementation with propolis and melatonin']","['clinical outcomes (APACHE II, SOFA and NUTRIC scores', 'inflammatory and oxidative stress markers', 'Inflammation, Oxidative Stress, and Clinical Outcomes', 'oxidative stress and hematological indices', 'gavage intake', '28-day survival rate', 'inflammation, clinical outcomes, and oxidative stress markers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0041281', 'cui_str': 'Tube feeding of patient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",55.0,0.282658,"In addition, the 28-day survival rate had no significant difference between the groups (P=0.07).
","[{'ForeName': 'Naseh', 'Initials': 'N', 'LastName': 'Pahlavani', 'Affiliation': ''}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Malekahmadi', 'Affiliation': ''}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sedaghat', 'Affiliation': ''}, {'ForeName': 'Amirabbas', 'Initials': 'A', 'LastName': 'Rostami', 'Affiliation': ''}, {'ForeName': 'Ola Kamal A', 'Initials': 'OKA', 'LastName': 'Alkadir', 'Affiliation': ''}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Taifi', 'Affiliation': ''}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Ranjbar', 'Affiliation': ''}, {'ForeName': 'AmirHossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': ''}, {'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': ''}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Beigmohammadi', 'Affiliation': ''}, {'ForeName': 'Mahdieh', 'Initials': 'M', 'LastName': 'Mir', 'Affiliation': ''}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Bagheri Moghaddam', 'Affiliation': ''}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Tabesh', 'Affiliation': ''}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Sadeghi', 'Affiliation': ''}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Gholizadeh Navashenaq', 'Affiliation': ''}, {'ForeName': 'Safieh', 'Initials': 'S', 'LastName': 'Firouzi', 'Affiliation': ''}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Fathi Najafi', 'Affiliation': ''}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Safarian', 'Affiliation': ''}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ghayour-Mobarhan', 'Affiliation': ''}]",Complementary medicine research,['10.1159/000523766']
2499,35220651,Serum keratin 19 (CYFRA21-1) is a prognostic biomarker in severe alcoholic hepatitis.,"BACKGROUND & AIMS


Up to 30% of patients with severe alcoholic hepatitis (sAH) die within three months of presentation. The degree of ductular reaction, characterized by accumulation of biliary and liver progenitor cells, confers a poor prognosis. Keratin fragments are established serological surrogates of liver injury and keratin 19 (K19) is a histological marker of the ductular reaction. We assessed the relationship between serum K19 levels (viz. CYFRA21-1), histology and outcome in patients with sAH.
METHODS


Serum CYFRA21-1 was quantified in pre-treatment serum samples from 824 patients enrolled in the STOPAH trial. The cohort was randomly divided into two groups to test mortality associations; histological analyses were performed using the 87 cases with suitable samples.
RESULTS


CYFRA21-1 levels were elevated in sAH and strongly predicted alcoholic steatohepatitis (ASH) on biopsy (area under the receiver operated characteristic [AUROC] 0.785 [95% Confidence Interval 0.602 - 0.967]) and 90-day survival (AUROC 0.684/0.693). The predictive ability of CYFRA21-1 was comparable with the model of end-stage liver disease (MELD) score and was independently associated with survival in multivariable analysis. CYFRA21-1 moderately correlated with hepatocellular injury markers M30/M65 but displayed a more robust predictive ability. A combination of MELD and CYFRA21-1 conferred a modest improvement in the AUROC value (0.731/0.743).
CONCLUSIONS


In sAH serum CYFRA21-1 levels associate with the presence of ASH on biopsy and independently predict 90-day survival. As a single marker performance is comparable to established scoring systems. Therefore CYFRA21-1, which is available in many clinical laboratories, may become a useful component of prognostic models.",2022,"RESULTS


CYFRA21-1 levels were elevated in sAH and strongly predicted alcoholic steatohepatitis (ASH) on biopsy (area under the receiver operated characteristic [AUROC] 0.785 [95% Confidence Interval 0.602 - 0.967]) and 90-day survival (AUROC 0.684/0.693).","['severe alcoholic hepatitis', 'Serum CYFRA21-1 was quantified in pre-treatment serum samples from 824 patients enrolled in the STOPAH trial', 'patients with sAH']",[],"['alcoholic steatohepatitis (ASH) on biopsy', 'serum K19 levels', '90-day survival']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019187', 'cui_str': 'Alcoholic hepatitis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C2718067', 'cui_str': 'Alcoholic steatohepatitis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010806', 'cui_str': 'Cytokeratin 19'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",824.0,0.0466634,"RESULTS


CYFRA21-1 levels were elevated in sAH and strongly predicted alcoholic steatohepatitis (ASH) on biopsy (area under the receiver operated characteristic [AUROC] 0.785 [95% Confidence Interval 0.602 - 0.967]) and 90-day survival (AUROC 0.684/0.693).","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Atkinson', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Aly', 'Affiliation': 'Medical Clinic III, Gastroenterology, Metabolic diseases and Intensive Care, University Hospital RWTH, Aachen, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Remih', 'Affiliation': 'Medical Clinic III, Gastroenterology, Metabolic diseases and Intensive Care, University Hospital RWTH, Aachen, Germany.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Tyson', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Guldiken', 'Affiliation': 'Medical Clinic III, Gastroenterology, Metabolic diseases and Intensive Care, University Hospital RWTH, Aachen, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldin', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Quaglia', 'Affiliation': ""Institute of Liver Studies, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Thursz', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Strnad', 'Affiliation': 'Medical Clinic III, Gastroenterology, Metabolic diseases and Intensive Care, University Hospital RWTH, Aachen, Germany.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.15218']
2500,35220649,Higher risk of kidney function decline with entecavir than tenofovir alafenamide in patients with chronic hepatitis B.,"BACKGROUND & AIMS


Entecavir (ETV) and tenofovir alafenamide (TAF) are the preferred agents in patients with predisposing factors for nephrotoxicity, but no studies to date have directly compared the renal safety of the two antiviral agents. Hence, we compared the risk of kidney function decline among patients with treatment-naïve chronic hepatitis B (CHB) treated with ETV or TAF.
METHODS


This study included 1,988 patients with treatment-naïve CHB who were treated with ETV (n = 1,839) or TAF (n = 149) between 2007 and 2020 for ETV, and between 2017 and 2020 for TAF. The primary outcome was chronic kidney disease (CKD) progression, defined as an increase in CKD stage by at least one stage for at least three consecutive months.
RESULTS


1:1 propensity score matching yielded 149 patients in each treatment group. The mean estimated glomerular filtration rate (eGFR) was 100.6 vs. 101.3 mL/min/1.73m 2  in the ETV and TAF group, respectively. A total of 61 patients developed a progression in CKD stage ≥1, of which 47 and 14 patients were from the ETV and TAF treated group, respectively (19.9 vs. 5.1 per 1,000 person-years; P < 0.001). The risk of progression in CKD stage ≥1 was significantly higher in patients treated with ETV, even when adjusted for potential confounders (adjusted hazard ratio 4.05; 95% CI, 2.14-7.68; P < 0.001).
CONCLUSIONS


ETV was associated with a higher risk of kidney function decline than TAF in patients with treatment-naïve CHB. Therefore, further prospective randomized studies are needed.",2022,"The mean estimated glomerular filtration rate (eGFR) was 100.6 vs. 101.3 mL/min/1.73m 2  in the ETV and TAF group, respectively.","['patients with treatment-naïve chronic hepatitis B (CHB) treated with ETV or TAF', '1,988 patients with treatment-naïve CHB who were treated with ETV (n = 1,839) or TAF (n = 149) between 2007 and 2020 for ETV, and between 2017 and 2020 for TAF', 'patients with predisposing factors for nephrotoxicity', 'patients with chronic hepatitis B']","['entecavir', 'tenofovir alafenamide', 'Entecavir (ETV) and tenofovir alafenamide (TAF', 'TAF']","['progression in CKD stage ≥1', 'chronic kidney disease (CKD) progression, defined as an increase in CKD stage', 'mean estimated glomerular filtration rate (eGFR', 'risk of progression in CKD stage ≥1', 'kidney function decline']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}]","[{'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",149.0,0.0452974,"The mean estimated glomerular filtration rate (eGFR) was 100.6 vs. 101.3 mL/min/1.73m 2  in the ETV and TAF group, respectively.","[{'ForeName': 'Chan-Young', 'Initials': 'CY', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyung Woo', 'Initials': 'HW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Up', 'Initials': 'SU', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Beom Seok', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.15208']
2501,35220641,Modulation of autophagy by an innovative phytocosmetic preparation (Myrothamnus flabelifolia and Coffea arabica) in human fibroblasts and its effects in a clinical randomized placebo-controlled trial.,"BACKGROUND


Autophagy is a natural and evolutionary mechanism that reduces cell toxic components and reutilizes metabolites to provide energy and renew cell function, which is linked to a wide range of age-related diseases, including those that affect the skin. Positive modulation of autophagy is useful to treat skin disorders and new active herbal products are potential candidates as autophagy modulators.
AIMS


The present study aimed to evaluate the effects of a phytocosmetic formulation containing Myrothamnus flabellifolia leaf and Coffea arabica seed plant extracts (MflCas) on the ubiquitin-proteasome and autophagy markers in human dermal fibroblasts, and investigate its topical skin effects in a randomized, simple-blind, and placebo-controlled trial.
METHODS


Human dermal fibroblasts were used to determine proteasome activity, protein carbonylation, LC3B protein, and lipofuscin production by luminescence and immune-enzymatic assays, and to determinate gene expression of autophagy biomarkers (Atg5, Atg7, EI24, EIF2A, Park2, foxo1, and mTOR) by RT-PCR. A clinical trial was conducted to evaluate the effects of MflCas on the hand, face, and forearms skin features after treatment by 56 days.
RESULTS


Topical treatment with MflCas improved several skin features of volunteers, mainly skin aging and pigmentation signals. On the hand skin, MflCas 2% after 56 days of treatment, reduced the spots length (30.8%), skin contrast (42.2%), and increased skin homogeneity (63.2%) and skin lightening effect (1.4%). On the face skin, topical treatment after 56 days reduced the spots length (21.5%), wrinkles area (8.1%), and wrinkles volume (5.6%) with an increment in face skin homogeneity (59.5%). These effects were related to the ability of MflCas to reduce proteasome activity protein carbonylation, and lipofuscin level, increase LC3B production, downregulate Atg7 and mTOR genes, and upregulate Park2 gene expressions.
CONCLUSIONS


The phytocosmetic preparation containing Myrothamnus flabellifolia leaf and Coffea arabica seed modulated ubiquitin-proteasome and autophagy process, representing an innovative and safe herbal preparation to improve skin features, mainly acting as skin anti-aging and lightening agent.",2022,"On the face skin, topical treatment after 56 days reduced the spots length (21.5%), wrinkles area (8.1%), and wrinkles volume (5.6%) with an increment in face skin homogeneity (59.5%).",['Human dermal fibroblasts'],"['innovative phytocosmetic preparation (Myrothamnus flabelifolia and Coffea arabica', 'MflCas', 'placebo', 'phytocosmetic formulation containing Myrothamnus flabellifolia leaf and Coffea arabica seed plant extracts (MflCas']","['face skin homogeneity', 'proteasome activity protein carbonylation, and lipofuscin level, increase LC3B production, downregulate Atg7 and mTOR genes, and upregulate Park2 gene expressions', 'skin contrast', 'spots length', 'proteasome activity, protein carbonylation, LC3B protein, and lipofuscin production by luminescence and immune-enzymatic assays, and to determinate gene expression of autophagy biomarkers (Atg5, Atg7, EI24, EIF2A, Park2, foxo1, and mTOR', 'wrinkles volume', 'skin homogeneity', 'skin lightening effect', 'several skin features of volunteers, mainly skin aging and pigmentation signals']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0016030', 'cui_str': 'Fibroblast'}]","[{'cui': 'C0521087', 'cui_str': 'Coffea arabica'}, {'cui': 'C3555538', 'cui_str': 'Myrothamnus flabellifolia leaf extract'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C0208355', 'cui_str': 'Multicatalytic endopeptidase complex'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1563721', 'cui_str': 'Carbonylation, Protein'}, {'cui': 'C0023789', 'cui_str': 'Lipofuscin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1868675', 'cui_str': 'Parkinson Disease 2, Autosomal Recessive Juvenile'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1450275', 'cui_str': 'Luminescence, Physical'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C2717977', 'cui_str': 'Enzymatic Assays'}, {'cui': 'C0205259', 'cui_str': 'Determinate'}, {'cui': 'C0004391', 'cui_str': 'Autophagocytosis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1306868', 'cui_str': 'Lightening of fetus'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",,0.0624509,"On the face skin, topical treatment after 56 days reduced the spots length (21.5%), wrinkles area (8.1%), and wrinkles volume (5.6%) with an increment in face skin homogeneity (59.5%).","[{'ForeName': 'Rafael C', 'Initials': 'RC', 'LastName': 'Biscaro', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Mussi', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Sufi', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Giovana', 'Initials': 'G', 'LastName': 'Padovani', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Flavio B', 'Initials': 'FB', 'LastName': 'Camargo Junior', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Wagner V', 'Initials': 'WV', 'LastName': 'Magalhães', 'Affiliation': 'Research and Development Department, Chemyunion Química Ltda, Sorocaba, Brazil.'}, {'ForeName': 'Luiz C', 'Initials': 'LC', 'LastName': 'Di Stasi', 'Affiliation': 'Laboratory of Phytomedicines, Pharmacology, and Biotechnology (PhytoPharmaTech), Department of Biophysics and Pharmacology, Institute of Biosciences, São Paulo State University (Unesp), Botucatu, Brazil.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14888']
2502,35220831,A randomized controlled study to compare first stick success with Instaflash technology: The FIRSST study.,"BACKGROUND


Peripheral intravenous catheters (PIVCs) are frequently used in clinical settings for intravenous access. Multiple attempts of PIVC insertions leads to patient discomfort, delay in treatment, associated complications, and extensive expenditure cost. Reduced number of attempts causes patient/nursing personnel satisfaction and expenditure costs. The present study evaluated performance efficacy of BD Venflon™ I with Instaflash needle technology (investigational device) as compared to the BD Venflon™ without Instaflash needle technology (control device).
METHODOLOGY


The PIVC insertions were randomized in the ratio 1:1 using either investigational or control device and were monitored for first stick success rate, ease of insertion, and patient satisfaction. Data was analyzed using R 4.0.3 and Microsoft Excel. Chi square test was used to establish association between two categorical variables.
RESULTS


In total, 1402 patients were analyzed for first attempt insertion success which showed 98.72% success rate in investigational device as compared to 88.87% success rate in case of the control device ( p  = 0.0004). Marginal differences were observed in ease of insertion in investigational (98.71%) and control devices (99%) signifying high satisfaction levels of nursing personnels. Positive responses were observed in investigational (98.01%) and control devices (99%) underlining satisfactory performances of overall patient experiences.
CONCLUSION


The present study showed that BD Venflon™ I with Instaflash needle technology enhanced first attempt insertion success rate along with marginal differences in its efficacy in comparison with the BD Venflon™ without Instaflash needle technology thus enhancing patient and nursing personnel satisfaction in turn making it a better alternative to be used in hospitals.",2022,Marginal differences were observed in ease of insertion in investigational (98.71%) and control devices (99%) signifying high satisfaction levels of nursing personnels.,[],"['Instaflash technology', 'Peripheral intravenous catheters (PIVCs', 'Instaflash needle technology (investigational device']","['Positive responses', 'number of attempts causes patient/nursing personnel satisfaction and expenditure costs']",[],"[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1402.0,0.0375587,Marginal differences were observed in ease of insertion in investigational (98.71%) and control devices (99%) signifying high satisfaction levels of nursing personnels.,"[{'ForeName': 'Arun Mavaji', 'Initials': 'AM', 'LastName': 'Seetharam', 'Affiliation': 'Department of Hospital Administration, M S Ramaiah Medical College and Hospitals, Bangalore, India.'}, {'ForeName': 'Umashankar', 'Initials': 'U', 'LastName': 'Raju', 'Affiliation': 'Department of Hospital Administration, M S Ramaiah Medical College and Hospitals, Bangalore, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Suresh', 'Affiliation': 'Department of Hospital Administration, M S Ramaiah Medical College and Hospitals, Bangalore, India.'}]",The journal of vascular access,['10.1177/11297298221080369']
2503,35221255,Septal versus apical pacing sites in permanent right ventricular pacing: The multicentre prospective SEPTAL-PM study.,"BACKGROUND


The optimal right ventricular pacing site for patients requiring pacemaker implantation for permanent atrioventricular block is a matter of debate. Long-term right ventricular apical pacing has been associated with left ventricular ejection fraction impairment and heart failure. Right ventricular septal pacing has been proposed as an alternative.
AIM


The aim of this randomized prospective multicentre trial was to compare left ventricular remodelling and outcomes between right ventricular apical and septal pacing after mid-term follow-up.
METHODS


Patients requiring pacemaker implantation for high-degree atrioventricular block were enrolled and randomized in a 1:1 fashion to receive a right ventricular apical or septal lead.
RESULTS


A total of 141 patients were included, 69 in the septal group and 72 in the apical group. Both groups exhibited similar left ventricular ejection fractions after 18 months of follow-up (septal 57.1±11.9% vs. apical 57.4±13.4%), and left ventricular ejection fraction variation was similar in the two groups at the end of follow-up (septal -1.5±13.2% vs. apical 0.3±13.3%). Additionally, left ventricular volume, quality of life and 6-minute walk distance were similar in the two groups. However, patients in the septal group were more likely to be asymptomatic, with a significantly lower concentration of N-terminal prohormone of brain natriuretic peptide. Lastly, lead position did not impact 18-month survival.
CONCLUSION


Pacing from the right ventricular apex does not have any detrimental effect on left ventricular systolic function compared with septal pacing over an 18-month period.",2022,"Additionally, left ventricular volume, quality of life and 6-minute walk distance were similar in the two groups.","['Patients requiring pacemaker implantation for high-degree atrioventricular block', 'A total of 141 patients were included, 69 in the septal group and 72 in the apical group', 'patients requiring pacemaker implantation for permanent atrioventricular block', 'permanent right ventricular pacing']","['right ventricular apical and septal pacing after mid-term follow-up', 'right ventricular apical or septal lead']","['left ventricular ejection fractions', 'left ventricular volume, quality of life and 6-minute walk distance', 'left ventricular systolic function', 'left ventricular ejection fraction variation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004245', 'cui_str': 'Atrioventricular block'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442004', 'cui_str': 'Septal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0442004', 'cui_str': 'Septal'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",141.0,0.0275694,"Additionally, left ventricular volume, quality of life and 6-minute walk distance were similar in the two groups.","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Galand', 'Affiliation': 'LTSI-UMR1099, université de Rennes, CHU Rennes, 35000 Rennes, France.'}, {'ForeName': 'Raphaël P', 'Initials': 'RP', 'LastName': 'Martins', 'Affiliation': 'LTSI-UMR1099, université de Rennes, CHU Rennes, 35000 Rennes, France.'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Donal', 'Affiliation': 'LTSI-UMR1099, université de Rennes, CHU Rennes, 35000 Rennes, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Behar', 'Affiliation': 'LTSI-UMR1099, université de Rennes, CHU Rennes, 35000 Rennes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Crocq', 'Affiliation': 'LTSI-UMR1099, université de Rennes, CHU Rennes, 35000 Rennes, France.'}, {'ForeName': 'Gaelle Gresis', 'Initials': 'GG', 'LastName': 'Soulié', 'Affiliation': 'LTSI-UMR1099, université de Rennes, CHU Rennes, 35000 Rennes, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Degand', 'Affiliation': 'Service de cardiologie, CHU Poitiers, 86021 Poitiers, France; Faculté de médecine et pharmacie, université de Poitiers, 86021 Poitiers, France; Inserm CIC 1402, CHU Poitiers, 86021 Poitiers, France.'}, {'ForeName': 'Rodrigue', 'Initials': 'R', 'LastName': 'Garcia', 'Affiliation': 'Service de cardiologie, CHU Poitiers, 86021 Poitiers, France; Faculté de médecine et pharmacie, université de Poitiers, 86021 Poitiers, France; Inserm CIC 1402, CHU Poitiers, 86021 Poitiers, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Solnon', 'Affiliation': ""Inserm, CNRS, l'Institut du Thorax, university of Nantes, Nantes, France.""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Lande', 'Affiliation': 'Service de cardiologie, CHU Poitiers, 86021 Poitiers, France; Faculté de médecine et pharmacie, université de Poitiers, 86021 Poitiers, France; Inserm CIC 1402, CHU Poitiers, 86021 Poitiers, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Probst', 'Affiliation': ""Inserm, CNRS, l'Institut du Thorax, university of Nantes, Nantes, France.""}, {'ForeName': 'Fatemi', 'Initials': 'F', 'LastName': 'Marjaneh', 'Affiliation': 'Department of cardiology, university hospital of Brest, 29609 Brest, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Mansourati', 'Affiliation': 'Department of cardiology, university hospital of Brest, 29609 Brest, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Dupuis', 'Affiliation': ""Service de cardiologie-rythmologie, université d'Angers, CHU d'Angers, 49933 Angers, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Laviolle', 'Affiliation': ""CIC Inserm 1414, centre d'investigation clinique de Rennes, 35000 Rennes, France.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leclercq', 'Affiliation': 'LTSI-UMR1099, université de Rennes, CHU Rennes, 35000 Rennes, France. Electronic address: Christophe.Leclercq@chu-rennes.fr.'}]",Archives of cardiovascular diseases,['10.1016/j.acvd.2021.12.007']
2504,35221232,Comparison of Retzius-sparing versus standard robot-assisted radical prostatectomy for prostate cancer.,"INTRODUCTION AND OBJECTIVES


We aim to compare the first year oncological and functional outcomes of Retzius-sparing robot-assisted radical prostatectomy (Rs-RARP) and standard robot-assisted radical prostatectomy (RARP).
MATERIALS AND METHODS


Eighty-eight patients who underwent robotic radical prostatectomy between 2018-2019 were included. We compared the minimum one-year follow-up results of patients who underwent Rs-RARP or RARP in terms of oncological and functional outcomes. Potency was assessed with the Sexual Health Inventory for Men (SHIM) score and was defined as an erection sufficient for penetration. Continence was defined as the absence of urinary incontinence with no safety pad. Patients were evaluated in the first month of follow-up and subsequently, every three months.
RESULTS


Forty-six patients in Rs-RARP and 42 patients in the RARP group were enrolled. Catheter removal time was shorter in the Rs-RARP group (12 vs. 14 days, p = 0.001). At the 1st month visit, 41 patients (%89) were continent (no pads) in the Rs-RARP group while 25 patients (%59) were continent in the RARP group (p = 0.001). Patients who underwent Rs-RARP achieved faster recovery of urinary continence (Log-rank, p = 0.001). After one year of follow-up, 43 patients (93%) in Rs-RARP group and 38 patients (90%) in RARP group were continent (p = 0.6). Potency rates were 38.7% in Rs-RARP and 34.4% in RARP group (p = 0.28). There were no cases of biochemical recurrence in any group.
CONCLUSIONS


Rs-RARP is a feasible technique, providing early return of continence. However, overall continence rates were similar at the end of the one-year follow-up.",2022,"Catheter removal time was shorter in the Rs-RARP group (12 vs. 14 days, p = 0.001).","['Eighty-eight patients who underwent', 'prostate cancer', 'between 2018-2019 were included', 'Forty-six patients in Rs-RARP and 42 patients in the RARP group were enrolled']","['RARP', 'RARP or RARP', 'Retzius-sparing robot-assisted radical prostatectomy (Rs-RARP) and standard robot-assisted radical prostatectomy (RARP', 'Retzius-sparing versus standard robot-assisted radical prostatectomy', 'robotic radical prostatectomy']","['overall continence rates', 'Sexual Health Inventory for Men (SHIM) score', 'biochemical recurrence', 'Potency rates', 'Catheter removal time', 'faster recovery of urinary continence']","[{'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3472504', 'cui_str': 'Sexual health inventory for men'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0542565', 'cui_str': 'Bladder control'}]",88.0,0.0358368,"Catheter removal time was shorter in the Rs-RARP group (12 vs. 14 days, p = 0.001).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tahra', 'Affiliation': 'Department of Urology, Health Sciences University, Umraniye Training & Research Hospital, Istanbul, Turkey. Electronic address: ahmettahra@gmail.com.'}, {'ForeName': 'U Tolga', 'Initials': 'UT', 'LastName': 'Sen', 'Affiliation': 'Department of Urology, Health Sciences University, Umraniye Training & Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sobay', 'Affiliation': 'Department of Urology, Health Sciences University, Umraniye Training & Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'İnkaya', 'Affiliation': 'Department of Urology, Health Sciences University, Umraniye Training & Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'E Veli', 'Initials': 'EV', 'LastName': 'Kucuk', 'Affiliation': 'Department of Urology, Health Sciences University, Umraniye Training & Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Boylu', 'Affiliation': 'Department of Urology, Health Sciences University, Umraniye Training & Research Hospital, Istanbul, Turkey.'}]",Actas urologicas espanolas,['10.1016/j.acuroe.2021.12.003']
2505,35221223,Dexmedetomidine Versus Propofol for Sedation After Adult Cardiac Surgery: A Trial Sequential Analysis.,,2022,,[],"['Propofol', 'Dexmedetomidine']",[],[],"[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.250724,,"[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Antel', 'Affiliation': 'Faculty of Medicine and Health Sciences, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, Quebec, Canada; Department of Anesthesia, Jewish General Hospital, Montreal, Quebec, Canada; Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cameron', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, Quebec, Canada; Department of Anesthesia, Jewish General Hospital, Montreal, Quebec, Canada; Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada. Electronic address: matthew.cameron@mcgill.ca.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2022.01.037']
2506,35221215,"Impact of Integrated Care Pathways Within the Framework of Collaborative Care on Older Adults With Anxiety, Depression, or Mild Cognitive Impairment.","OBJECTIVES


To evaluate the impact of an Integrated Care Pathway (ICP) within a collaborative care framework for anxiety, depression and mild cognitive impairment (MCI) on clinical outcomes, quality of life, and time to treatment initiation.
DESIGN


Prospective Cohort study.
SETTING


Primary care practices in Toronto and Hamilton, Ontario, Canada.
PARTICIPANTS


Patients of participating primary care practices born in the years 1950 to 1958.
SAMPLE SIZE


Target 150 participants, 75 in ICP and 75 in Treatment-As-Usual (TAU) arm.
INTERVENTION


ICP within a collaborative care framework and TAU.
METHODS AND RESULTS


One hundred forty-five participants with anxiety, depression or MCI, from five primary care practices were enrolled: 69 were managed as per ICP and 76 as per TAU. All underwent outcome assessments at 6, 12, 18, and 24 months. Compared to TAU, ICP participants had a significantly higher rate of improvement in depression symptoms (β = -0.620, F (1, 256) = 4.10, p = 0.044), anxiety symptoms (β = -0.593, F (1, 223) = 4.00, p = 0.047), and quality of life (β = 1.351, F(1, 358) = 6.58, p = 0.011). The ICP group had also a significantly higher ""hazard"" of treatment initiation (HR = 3.557; 95% CI: [2.228, 5.678]; p < 0.001) after controlling for age, gender and baseline severity of symptoms compared to TAU group.
CONCLUSIONS


Use of an ICP within a collaborative care framework in primary care settings for anxiety, depression and MCI among older adults, results in faster reductions in clinical symptoms and improvement in quality of life compared to usual care, as well as faster access to recommended treatments.",2022,"Compared to TAU, ICP participants had a significantly higher rate of improvement in depression symptoms (β = -0.620, F (1, 256) = 4.10, p = 0.044), anxiety symptoms (β = ","['150 participants, 75 in ICP and 75 in Treatment-As-Usual (TAU) arm', 'Patients of participating primary care practices born in the years 1950 to 1958', 'Primary care practices in Toronto and Hamilton, Ontario, Canada', 'One hundred forty-five participants with anxiety, depression or MCI, from five primary care practices were enrolled: 69 were managed as per ICP and 76 as per TAU', 'Older Adults With Anxiety, Depression, or Mild Cognitive Impairment', 'older adults']","['ICP', 'Integrated Care Pathway (ICP', 'TAU, ICP']","['clinical outcomes, quality of life, and time to treatment initiation', 'depression symptoms', 'hazard"" of treatment initiation', 'anxiety symptoms', 'quality of life']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456587', 'cui_str': '1958'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0303040', 'cui_str': 'Arsenic-76'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",145.0,0.0610382,"Compared to TAU, ICP participants had a significantly higher rate of improvement in depression symptoms (β = -0.620, F (1, 256) = 4.10, p = 0.044), anxiety symptoms (β = ","[{'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Dham', 'Affiliation': 'Division of Adult Neurodevelopment and Geriatric Psychiatry (PD, NM, HZ, LL), Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry (PD), University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'McAiney', 'Affiliation': 'School of Public Health Sciences (CM), University of Waterloo, Waterloo, Ontario, Canada; Schlegel-UW Research Institute for Aging (CM), Waterloo, Ontario, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Saperson', 'Affiliation': 'Department of Psychiatry & Behavioral Neurosciences, Michael G. DeGroote School of Medicine (KS, NK), McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Centre for Complex Interventions, Centre for Addiction and Mental Health (WW), Toronto, Ontario, Canada.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Malik', 'Affiliation': 'Division of Adult Neurodevelopment and Geriatric Psychiatry (PD, NM, HZ, LL), Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Parascandalo', 'Affiliation': 'Department of Family Medicine (FP, DO), McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Haoyu', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Division of Adult Neurodevelopment and Geriatric Psychiatry (PD, NM, HZ, LL), Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Lourenco', 'Affiliation': 'Division of Adult Neurodevelopment and Geriatric Psychiatry (PD, NM, HZ, LL), Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Oliver', 'Affiliation': 'Department of Family Medicine (FP, DO), McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Kates', 'Affiliation': 'Department of Psychiatry & Behavioral Neurosciences, Michael G. DeGroote School of Medicine (KS, NK), McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Division of Adult Neurodevelopment and Geriatric Psychiatry (PD, NM, HZ, LL), Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry (PD), University of Toronto, Toronto, Ontario, Canada; Toronto Dementia Research Alliance (TR), University of Toronto, Toronto, Ontario, Canada. Electronic address: tarek.rajji@camh.ca.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2022.01.010']
2507,35221464,Effects of azithromycin on ventricular repolarization in children with COVID-19.,"Azithromycin is used to treat pediatric COVID-19 patients. It can also prolong the QT interval in adults. This study assessed the effects of azithromycin on ventricular repolarization in children with COVID-19.Method: The study prospectively enrolled children with COVID-19 who received azithromycin between July and August 2020. An electrocardiogram was performed before, one, three, and five days after treatment. Using ImageJ ®, the following parameters were measured: QT max, QT min, Tp-e max, and Tp-e min. The parameters QTc max, QTc min, Tp-ec max, Tp-ec min, QTcd, Tp-ecd, and the QTc/Tp-ec ratio were calculated using Bazett's formula.Results: The study included 105 pediatric patients (mean age 9.8±5.3 years). The pretreatment heart rate was higher than after treatment (before 92 79-108]/min vs. Day 1 82 [69-108)]/min vs. Day 3 80 [68-92.2]/min vs. Day 5 81 [70-92]/min; p=0.05).Conclusion Azithromycin does not affect the ventricular repolarization parameters on ECG in pediatric COVID-19 cases.",2022,[70-92]/min; p=0.05).Conclusion Azithromycin does not affect the ventricular repolarization parameters on ECG in pediatric COVID-19 cases.,"['between July and August 2020', '105 pediatric patients (mean age 9.8±5.3 years', 'pediatric COVID-19 patients', 'children with COVID-19', 'enrolled children with COVID-19 who received', 'children with COVID-19.Method']","['azithromycin', 'Azithromycin']","['ventricular repolarization parameters', 'ventricular repolarization', 'parameters QTc max, QTc min, Tp-ec max, Tp-ec min, QTcd, Tp-ecd, and the QTc', 'pretreatment heart rate', 'Tp-ec ratio', 'QT max, QT min, Tp-e max, and Tp-e min']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0014116', 'cui_str': 'Endocardial cushion defect'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",105.0,0.0454075,[70-92]/min; p=0.05).Conclusion Azithromycin does not affect the ventricular repolarization parameters on ECG in pediatric COVID-19 cases.,"[{'ForeName': 'Suleyman', 'Initials': 'S', 'LastName': 'Sunkak', 'Affiliation': 'Kayseri City Hospital, Kayseri, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Argun', 'Affiliation': 'Department of Pediatrics, Pediatric Cardiology Division, Kayseri Education and Research City Hospital, Kayseri, Turkey.'}, {'ForeName': 'Binnaz', 'Initials': 'B', 'LastName': 'Celik', 'Affiliation': 'Department of Pediatrics, Kayseri Education and Research City Hospital, Kayseri, Turkey.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Tasci', 'Affiliation': 'Department of Pediatrics, Pediatric Cardiology Division, Sivas Numune State Hospital, Sivas, Turkey.'}, {'ForeName': 'Agah Bahadir', 'Initials': 'AB', 'LastName': 'Ozturk', 'Affiliation': 'Department of Pediatrics, Kayseri Education and Research City Hospital, Kayseri, Turkey.'}, {'ForeName': 'Dogan Bahadir', 'Initials': 'DB', 'LastName': 'Inan', 'Affiliation': 'Department of Pediatrics, Kayseri Education and Research City Hospital, Kayseri, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Dogan', 'Affiliation': 'Department of Pediatrics, Pediatric Cardiology Division, Kayseri Education and Research City Hospital, Kayseri, Turkey.'}]",Revista portuguesa de cardiologia : orgao oficial da Sociedade Portuguesa de Cardiologia = Portuguese journal of cardiology : an official journal of the Portuguese Society of Cardiology,['10.1016/j.repc.2021.04.008']
2508,35221428,Effect of external cold and thermomechanical stimulation on anxiety and pain during intravenous cannulation among children.,"Pain and anxiety are the most common and prevalent adverse stimuli experienced by hospitalised children. The most frightening and distressing source of pain and anxiety accounted for is due to venipuncture. This study aimed to assess the effect of cold and thermomechanical stimulation on pain and anxiety during intravenous (IV) cannulation among children. We conducted a prospective parallel-group randomised control trial in children who required IV cannulation. In the intervention group, external cold and thermomechanical stimulation was applied before 60 seconds, above 5 cm over IV cannulation site through Buzzy device, while the control group received routine care. Children's level of anxiety and pain was assessed using the Children's Fear Scale (CFS) and Wong-Baker Faces pain Scale (WBFS). Mean scores of the self-reported procedural level of pain were less in the intervention group as compared to the control group (2.80 ± 1.86, 7.47 ± 2.40). Median of procedural pain level showed a significant difference between the intervention and control group at  p  < 0.001, inferring that the Buzzy device strongly resulted in a reduction of perception of pain during the cannulation procedure. However, no significant difference was observed in the median of the procedural level of anxiety between the two groups ( p  = 0.208), stating that cold and thermomechanical stimulation did not affect the level of anxiety of children. Nevertheless, the combination of cold and thermomechanical stimulation through the Buzzy device did not have a significant impact on the procedural level of anxiety among children. Still, it could optimally alleviate the level of pain.",2021,"Mean scores of the self-reported procedural level of pain were less in the intervention group as compared to the control group (2.80 ± 1.86, 7.47 ± 2.40).","['children who required IV cannulation', 'children']","['external cold and thermomechanical stimulation', 'cold and thermomechanical stimulation']","['Mean scores of the self-reported procedural level of pain', 'Median of procedural pain level', 'perception of pain', 'median of the procedural level of anxiety', ""Children's level of anxiety and pain"", 'pain and anxiety', 'Pain and anxiety', ""Children's Fear Scale (CFS) and Wong-Baker Faces pain Scale (WBFS"", 'anxiety and pain', 'level of anxiety of children']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",,0.0626125,"Mean scores of the self-reported procedural level of pain were less in the intervention group as compared to the control group (2.80 ± 1.86, 7.47 ± 2.40).","[{'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Gahlawat', 'Affiliation': 'Nursing Officer, ESIC Hospital, Delhi, India.'}, {'ForeName': 'Malar', 'Initials': 'M', 'LastName': 'Kodi', 'Affiliation': 'Assistant Professor, College of Nursing, All India Institute of Medical Sciences, Rishikesh, Uttrakhand, India.'}, {'ForeName': 'Rupinder', 'Initials': 'R', 'LastName': 'Deol', 'Affiliation': 'Assistant Professor, College of Nursing, All India Institute of Medical Sciences, Rishikesh, Uttrakhand, India.'}]",Sudanese journal of paediatrics,['10.24911/SJP.106-1590387019']
2509,35221361,Measurement of bupivacaine induced myotoxicity in interfascial plane blocks: A randomised controlled trial.,"Background and Aims


Recent reports of local-anaesthetic induced myotoxicity after peripheral nerve blocks have increased interest in this less commonly known complication. Although the morphological, physiological and biochemical changes in muscle after injection of clinically used concentration of bupivacaine have been studied in animals, little research has been conducted on human subjects, especially in relation to fascial plane blocks. We conducted a study to examine the changes in circulating creatine phosphokinase (CPK) levels in patients undergoing modified radical mastectomy (MRM) or mesh hernioplasty (MH) with or without peripheral nerve blocks. The study explored local anaesthetic (bupivacaine) induced myotoxicity by measuring changes in serum CPK levels following transversus abdominis plane block (TAP) or pectoral nerve block-II (PEC- II) in patients undergoing MH or MRM, respectively.
Methods


The study was a randomised, controlled open-label trial. Patients undergoing MH who were randomised to the intervention group received TAP block whereas those undergoing MRM received PEC-II block. Blood samples were drawn at baseline, 6 and 24 hours after surgery for serum CPK measurements. Changes in serum CPK levels between the control and intervention groups were compared using repeated-measures analysis of variance.
Results


Baseline serum CPK levels were similar between the groups. There was a significant difference in the change in serum CPK levels between the groups. It significantly rose in the intervention group as compared to the control group (p < 0.001).
Conclusion


The study shows that serum CPK levels significantly increase at 24 hours after interfascial plane block thereby indirectly indicating myotoxicity. Further research is needed to ascertain its clinical impact.",2021,"It significantly rose in the intervention group as compared to the control group (p < 0.001).
","['patients undergoing MH or MRM, respectively', 'Patients undergoing MH', 'interfascial plane blocks', 'patients undergoing']","['modified radical mastectomy (MRM) or mesh hernioplasty (MH) with or without peripheral nerve blocks', 'transversus abdominis plane block (TAP) or pectoral nerve block-II (PEC- II', 'local anaesthetic (bupivacaine', 'bupivacaine', 'TAP block']","['circulating creatine phosphokinase (CPK) levels', 'serum CPK levels', 'Baseline serum CPK levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0750860', 'cui_str': 'Serum creatine phosphokinase'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.0886889,"It significantly rose in the intervention group as compared to the control group (p < 0.001).
","[{'ForeName': 'Vasundhara', 'Initials': 'V', 'LastName': 'Rakhi', 'Affiliation': 'Department of Anaesthesiology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Kaushal', 'Affiliation': 'Department of Anaesthesiology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India.'}, {'ForeName': 'Surinder', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India.'}]",Indian journal of anaesthesia,['10.4103/ija.ija_848_21']
2510,35221357,"Effect of prophylactic combination of glycopyrrolate, ondansetron, and ephedrine upon hypotension during obstetric spinal anaesthesia-A randomised controlled trial.","Background and Aims


Various pharmacological and non-pharmacological strategies have been employed to minimise hypotension during obstetric spinal anaesthesia. We compared a prophylactic combination of glycopyrrolate, ondansetron, and ephedrine in terms of total vasopressor consumption, with standard treatment in this randomised controlled trial.
Methods


One hundred patients undergoing elective caeserean sections were randomly divided into two groups of 50 each, the study group received prophylactic ondansetron and glycopyrrolate boluses followed by an infusion of ephedrine, while the control group received ephedrine boluses as required. The total ephedrine consumption (primary objective), incidence and degree of hypotension, heart rate variations, and neonatal APGAR scores (secondary objectives) were analysed.
Results


The median ephedrine requirement was lesser in the study group compared to the control group [13.2 mg (10--15.75) vs. 27.7 mg (12--24)], with a  P  value of 0.02. Fewer participants experienced hypotension in the study group before baby delivery compared to the control group (12 vs. 36,  P  = 0.004). Heart rate was higher in the study group. No significant differences were observed in neonatal APGAR scores and incidence of adverse events.
Conclusion


A combination of glycopyrrolate, ondansetron, and ephedrine might offer better haemodynamic stability and reduce vasopressor consumption in obstetric patients undergoing spinal anaesthesia as opposed to standard treatment.",2021,"No significant differences were observed in neonatal APGAR scores and incidence of adverse events.
","['One hundred patients undergoing elective caeserean sections', 'obstetric patients undergoing spinal anaesthesia', 'upon hypotension during obstetric spinal anaesthesia']","['prophylactic ondansetron and glycopyrrolate boluses followed by an infusion of ephedrine', 'glycopyrrolate, ondansetron, and ephedrine', 'ephedrine boluses']","['total ephedrine consumption (primary objective), incidence and degree of hypotension, heart rate variations, and neonatal APGAR scores (secondary objectives', 'Heart rate', 'neonatal APGAR scores and incidence of adverse events', 'haemodynamic stability', 'median ephedrine requirement', 'hypotension', 'vasopressor consumption', 'total vasopressor consumption']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}]",100.0,0.455691,"No significant differences were observed in neonatal APGAR scores and incidence of adverse events.
","[{'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Vadhanan', 'Affiliation': 'Department of Anaesthesiology, Vinayaka Missions Medical College, Karaikal, Puducherry, India.'}, {'ForeName': 'Cheran', 'Initials': 'C', 'LastName': 'Kalyanasundaram', 'Affiliation': 'Department of Anaesthesiology, Vinayaka Missions Medical College, Karaikal, Puducherry, India.'}, {'ForeName': 'Subbulakshmi', 'Initials': 'S', 'LastName': 'Sundaram', 'Affiliation': 'Department of Anaesthesiology, Rajah Muthiah Medical College and Hospital, Annamalai University, Chidambaram, Tamil Nadu, India.'}, {'ForeName': 'Iniya', 'Initials': 'I', 'LastName': 'Rajendran', 'Affiliation': 'Department of Anaesthesiology, Vinayaka Missions Medical College, Karaikal, Puducherry, India.'}, {'ForeName': 'Preethipriyadarshini', 'Initials': 'P', 'LastName': 'Rajasekar', 'Affiliation': 'Department of Anaesthesiology, Vinayaka Missions Medical College, Karaikal, Puducherry, India.'}]",Indian journal of anaesthesia,['10.4103/ija.ija_870_21']
2511,35221758,"The Efficacy and Safety of Dexmedetomidine for Procedural Sedation in Patients Receiving Local Anesthesia Outside the Intensive Care Unit: A Prospective, Double-Blind, Randomized Clinical Phase III Trial in Japan.","Background


Few studies (in other countries than the US) have reported on the efficacy and safety of dexmedetomidine for sedation of patients undergoing surgical or medical procedures under local anesthesia without intubation outside the intensive care unit. We performed a randomized, double-blind study in Japan.
Methods


Adult patients were randomly allocated to receive placebo, dexmedetomidine 0.5 μg/kg (DEX 0.5 group), or dexmedetomidine 1.0 μg/kg (DEX 1.0 group) over 10 min. Then, both dexmedetomidine groups received dexmedetomidine 0.2-0.7 μg/kg/h for maintaining an Observer's Assessment of Alertness/Sedation Scale (OAA/S) score of ≤ 4; however, propofol was administered to rescue patients whose score exceeded this value. The primary endpoint was the percentage of patients who did not require rescue propofol to achieve and maintain an OAA/S score of ≤ 4.
Results


In total, 162 patients were included in the placebo ( n  = 53), DEX 0.5 ( n  = 53), and DEX 1.0 ( n  = 56) groups. Propofol was not required in significantly more patients in the dexmedetomidine 0.5 and 1.0 μg/kg groups (52.8% and 57.1%, respectively) compared with the placebo group (1.9%) ( P  < 0.001 for both). Common adverse events were protocol-defined hypotension, respiratory depression and bradycardia. The incidence of bradycardia was significantly higher in the DEX 0.5 (26.4%) and DEX 1.0 (30.4%) groups than in the placebo group (9.4%) ( P  = 0.041 and  P  = 0.008, respectively).
Conclusion


We concluded that a loading dose of 0.5 or 1.0 μg/kg dexmedetomidine followed by infusion at a rate of 0.2-0.7 μg/kg/h provided effective and well-tolerated sedation in patients undergoing surgical or medical procedures under local anesthesia without intubation.
Clinical trials.gov identifier: NCT01438931.",2022,"The incidence of bradycardia was significantly higher in the DEX 0.5 (26.4%) and DEX 1.0 (30.4%) groups than in the placebo group (9.4%) ( P  = 0.041 and  P  = 0.008, respectively).
","['patients undergoing surgical or medical procedures under local anesthesia without intubation outside the intensive care unit', '162 patients were included in the', 'Methods\n\n\nAdult patients', 'Japan', 'Patients Receiving Local Anesthesia Outside the Intensive Care Unit', 'patients undergoing surgical or medical procedures under local anesthesia without intubation']","['Propofol', 'placebo', 'dexmedetomidine', 'DEX', 'placebo, dexmedetomidine 0.5 μg/kg (DEX 0.5 group), or dexmedetomidine 1.0 μg/kg (DEX 1.0 group) over 10 min', 'propofol', 'Dexmedetomidine']","['hypotension, respiratory depression and bradycardia', 'percentage of patients who did not require rescue propofol to achieve and maintain an OAA/S score of ≤ 4', 'Alertness/Sedation Scale (OAA/S) score', 'efficacy and safety', 'incidence of bradycardia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0199171', 'cui_str': 'Medical procedure'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",162.0,0.538062,"The incidence of bradycardia was significantly higher in the DEX 0.5 (26.4%) and DEX 1.0 (30.4%) groups than in the placebo group (9.4%) ( P  = 0.041 and  P  = 0.008, respectively).
","[{'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Inagaki', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, School of Medicine, Faculty of Medicine, Tottori University, Yonago 683-8504, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Morita', 'Affiliation': 'Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science, Okayama 700-8558, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ozaki', 'Affiliation': ""Department of Anesthesiology, Tokyo Women's Medical University, Tokyo 162-8666, Japan.""}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Saitama Medical University International Medical Center, Hidaka 350-1298; and Higashimatsuyama Medical Association Hospital, Higashimatsuyama 355-0021, Japan.'}, {'ForeName': 'Akifumi', 'Initials': 'A', 'LastName': 'Okayama', 'Affiliation': 'Clinical Statistics Group 2, Biometrics & Data Management, Pfizer R&D Japan, Tokyo 151-8589, Japan.'}, {'ForeName': 'Nobuyo', 'Initials': 'N', 'LastName': 'Oya', 'Affiliation': 'Clinical Development Department, Maruishi Pharmaceutical Co., Ltd., Osaka 538-0042, Japan.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Hiraoka', 'Affiliation': 'Clinical Development Department, Maruishi Pharmaceutical Co., Ltd., Osaka 538-0042, Japan.'}, {'ForeName': 'Junzo', 'Initials': 'J', 'LastName': 'Takeda', 'Affiliation': 'Department of Anesthesiology, Keio University School of Medicine, Tokyo 151-8589, Japan; and National Hospital Organization, Tokyo Medical Center, Tokyo 152-8902, Japan.'}]",Yonago acta medica,['10.33160/yam.2022.02.005']
2512,35212055,Evaluating an online self-help intervention for parents of children with food allergies.,"BACKGROUND


Parents of children with food allergies (CwFA) experience reduced quality of life (QoL) and may have reduced access to in-person interventions in the COVID-19 pandemic. This trial developed and evaluated an online, self-help, information provision website, aimed at improving QoL in parents of CwFA.
METHODS


In a single-blinded, randomised controlled trial (RCT), participants were randomised to either receive access to the website or a waiting-list control. At baseline, post-intervention (week 4) and follow-up (week 8), measures of parental food allergy-related QoL, depression, anxiety, stress, intolerance of uncertainty (IU) and self-efficacy were obtained.
RESULTS


A total of 205 participants were randomised; 97% were females, 91% white and 78% educated ≥ degree level, with a mean age of 38.95 years (SD = 6.89). 44.9% (n = 92) were retained at follow-up. The arms did not significantly differ on any outcome at any time point. For a sub-group of participants above the clinical cut-off for depression at baseline, the intervention may have improved QoL. Participants reported the website content as useful and accessible, but accessed it infrequently. In baseline data, IU and self-efficacy were significantly associated with QoL.
CONCLUSION


While the COVID-19 pandemic has encouraged greater provision of online interventions, our RCT suggests this particular website is not suitable for this population in general, although future research could examine its efficacy for depressed parents of CwFA, to increase confidence that the sub-group finding was not a Type 1 error. The baseline data suggest IU and self-efficacy remain potential proximal targets for intervention.",2022,"This trial developed and evaluated an online, self-help, information provision website, aimed at improving QoL in parents of CwFA.
","['Parents of children with food allergies (CwFA', 'parents of CwFA', 'parents of children with food allergies', 'A total of 205 participants were randomised; 97% were females, 91% white and 78% educated ≥ degree level, with a mean age of 38.95\xa0years (SD\xa0=\xa06.89']","['online self-help intervention', 'receive access to the website or a waiting-list control']","['quality of life (QoL', 'parental food allergy-related QoL, depression, anxiety, stress, intolerance of uncertainty (IU) and self-efficacy']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",205.0,0.314782,"This trial developed and evaluated an online, self-help, information provision website, aimed at improving QoL in parents of CwFA.
","[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Sugunasingha', 'Affiliation': 'Salomons Institute for Applied Psychology, Canterbury Christ Church University, Tunbridge Wells, UK.'}, {'ForeName': 'Fergal W', 'Initials': 'FW', 'LastName': 'Jones', 'Affiliation': 'Salomons Institute for Applied Psychology, Canterbury Christ Church University, Tunbridge Wells, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'du Toit', 'Affiliation': ""Evelina Children's Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Jones', 'Affiliation': 'School of Psychology, University of Surrey, Guildford, UK.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13731']
2513,35212639,Evaluation of an Experimental Web-based Educational Module on Opioid-related Occupational Safety Among Police Officers: Protocol for a Randomized Pragmatic Trial to Minimize Barriers to Overdose Response.,"BACKGROUND


As drug-related morbidity and mortality continue to surge, police officers are on the front lines of the North American overdose (OD) crisis. Drug law enforcement shapes health risks among people who use drugs (PWUD), while also impacting the occupational health and wellness of officers. Effective interventions to align law enforcement practices with public health and occupational safety goals remain underresearched.
OBJECTIVE


The Opioids and Police Safety Study (OPS) aims to shift police practices relating to PWUD. It adapts and evaluates the relative effectiveness of a curriculum that bundles content on public health promotion with occupational risk reduction (ORR) to supplement a web-based OD response and naloxone training platform (GetNaloxoneNow.org, or GNN). This novel approach has the potential to improve public health and occupational safety practices, including using naloxone to reverse ODs, referring PWUD to treatment and other supportive services, and avoiding syringe confiscation.
METHODS


This longitudinal study uses a randomized pragmatic trial design. A sample of 300 active-duty police officers from select counties in Pennsylvania, Vermont, and New Hampshire with high OD fatality rates will be randomized (n=150 each) to either the experimental arm (GNN + OPS) or the control arm (GNN + COVID-19 ORR). A pre- and posttraining survey will be administered to all 300 officers, after which they will be administered quarterly surveys for 12 months. A subsample of police officers will also be qualitatively followed in a simultaneous embedded mixed-methods approach. Research ethics approval was obtained from the New York University Institutional Review Board.
RESULTS


Results will provide an understanding of the experiences, knowledge, and perceptions of this sample of law enforcement personnel. Generalized linear models will be used to analyze differences in key behavioral outcomes between the participants in each of the 2 study arms and across multiple time points (anticipated minimum effect size to be detected, d=0.50). Findings will be disseminated widely, and the training products will be available nationally once the study is completed.
CONCLUSIONS


The OPS is the first study to longitudinally assess the impact of a web-based opioid-related ORR intervention for law enforcement in the U.S. Our randomized pragmatic clinical trial aims to remove barriers to life-saving police engagement with PWUD/people who inject drugs by focusing both on the safety of law enforcement and evidence-based and best practices for working with persons at risk of an opioid OD. Our simultaneous embedded mixed-methods approach will provide empirical evaluation of the diffusion of the naloxone-based response among law enforcement.
TRIAL REGISTRATION


ClinicalTrail.gov NCT05008523; https://clinicaltrials.gov/show/NCT05008523.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/33451.",2022,Our randomized pragmatic clinical trial aims to remove barriers to life-saving police engagement with PWUD/people who inject drugs by focusing both on the safety of law enforcement and evidence-based and best practices for working with persons at risk of an opioid OD.,"['people who use drugs (PWUD', 'A sample of 300 active-duty police officers from select counties in Pennsylvania, Vermont, and New Hampshire with high OD fatality rates']","['naloxone training platform (GetNaloxoneNow.org, or GNN', 'naloxone', 'experimental arm (GNN + OPS) or the control arm (GNN + COVID-19 ORR', 'web-based opioid-related ORR intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086825', 'cui_str': 'Policeman'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0042537', 'cui_str': 'Vermont'}, {'cui': 'C0027969', 'cui_str': 'New Hampshire'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0085098', 'cui_str': 'Police'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],300.0,0.0616385,Our randomized pragmatic clinical trial aims to remove barriers to life-saving police engagement with PWUD/people who inject drugs by focusing both on the safety of law enforcement and evidence-based and best practices for working with persons at risk of an opioid OD.,"[{'ForeName': 'Janie', 'Initials': 'J', 'LastName': 'Simmons', 'Affiliation': 'Department of Social and Behavioral Sciences, School of Global Public Health, New York University, New York, NY, United States.'}, {'ForeName': 'Luther', 'Initials': 'L', 'LastName': 'Elliott', 'Affiliation': 'Department of Social and Behavioral Sciences, School of Global Public Health, New York University, New York, NY, United States.'}, {'ForeName': 'Alex S', 'Initials': 'AS', 'LastName': 'Bennett', 'Affiliation': 'Department of Social and Behavioral Sciences, School of Global Public Health, New York University, New York, NY, United States.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Beletsky', 'Affiliation': 'School of Law and Bouvé College of Health Sciences, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Rajan', 'Affiliation': 'Department of Health and Behavior Studies, Teachers College, Columbia University, New York, NY, United States.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Anders', 'Affiliation': 'NDRI-USA, New York, NY, United States.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Dastparvardeh', 'Affiliation': 'Department of Social and Behavioral Sciences, School of Global Public Health, New York University, New York, NY, United States.'}]",JMIR research protocols,['10.2196/33451']
2514,35212635,The 3-Month Effectiveness of a Stratified Blended Physiotherapy Intervention in Patients With Nonspecific Low Back Pain: Cluster Randomized Controlled Trial.,"BACKGROUND


Patient education, home-based exercise therapy, and advice on returning to normal activities are established physiotherapeutic treatment options for patients with nonspecific low back pain (LBP). However, the effectiveness of physiotherapy interventions on health-related outcomes largely depends on patient self-management and adherence to exercise and physical activity recommendations. e-Exercise LBP is a recently developed stratified blended care intervention comprising a smartphone app integrated with face-to-face physiotherapy treatment. Following the promising effects of web-based applications on patients' self-management skills and adherence to exercise and physical activity recommendations, it is hypothesized that e-Exercise LBP will improve patients' physical functioning.
OBJECTIVE


This study aims to investigate the short-term (3 months) effectiveness of stratified blended physiotherapy (e-Exercise LBP) on physical functioning in comparison with face-to-face physiotherapy in patients with nonspecific LBP.
METHODS


The study design was a multicenter cluster randomized controlled trial with intention-to-treat analysis. Patients with nonspecific LBP aged ≥18 years were asked to participate in the study. The patients were treated with either stratified blended physiotherapy or face-to-face physiotherapy. Both interventions were conducted according to the Dutch physiotherapy guidelines for nonspecific LBP. Blended physiotherapy was stratified according to the patients' risk of developing persistent LBP using the Keele STarT Back Screening Tool. The primary outcome was physical functioning (Oswestry Disability Index, range 0-100). Secondary outcomes included pain intensity, fear-avoidance beliefs, and self-reported adherence. Measurements were taken at baseline and at the 3-month follow-up.
RESULTS


Both the stratified blended physiotherapy group (104/208, 50%) and the face-to-face physiotherapy group (104/208, 50%) had improved clinically relevant and statistically significant physical functioning; however, there was no statistically significant or clinically relevant between-group difference (mean difference -1.96, 95% CI -4.47 to 0.55). For the secondary outcomes, stratified blended physiotherapy showed statistically significant between-group differences in fear-avoidance beliefs and self-reported adherence. In patients with a high risk of developing persistent LBP (13/208, 6.3%), stratified blended physiotherapy showed statistically significant between-group differences in physical functioning (mean difference -16.39, 95% CI -27.98 to -4.79) and several secondary outcomes.
CONCLUSIONS


The stratified blended physiotherapy intervention e-Exercise LBP is not more effective than face-to-face physiotherapy in patients with nonspecific LBP in improving physical functioning in the short term. For both stratified blended physiotherapy and face-to-face physiotherapy, within-group improvements were clinically relevant. To be able to decide whether e-Exercise LBP should be implemented in daily physiotherapy practice, future research should focus on the long-term cost-effectiveness and determine which patients benefit most from stratified blended physiotherapy.
TRIAL REGISTRATION


ISRCTN Registry 94074203; https://doi.org/10.1186/ISRCTN94074203.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-https://doi.org/10.1186/s12891-020-3174-z.",2022,e-Exercise LBP is not more effective than face-to-face physiotherapy in patients with nonspecific LBP in improving physical functioning in the short term.,"['patients with nonspecific LBP', 'Patients with nonspecific LBP aged ≥18 years', 'Patients With Nonspecific Low Back Pain', 'patients with nonspecific low back pain (LBP']","['stratified blended physiotherapy intervention', 'Stratified Blended Physiotherapy Intervention', 'physiotherapy interventions', 'Blended physiotherapy', 'stratified blended physiotherapy (e-Exercise LBP', 'stratified blended physiotherapy or face-to-face physiotherapy']","['fear-avoidance beliefs and self-reported adherence', 'physical functioning (Oswestry Disability Index, range 0-100', 'pain intensity, fear-avoidance beliefs, and self-reported adherence', 'physical functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.0407222,e-Exercise LBP is not more effective than face-to-face physiotherapy in patients with nonspecific LBP in improving physical functioning in the short term.,"[{'ForeName': 'Tjarco', 'Initials': 'T', 'LastName': 'Koppenaal', 'Affiliation': 'Research Group Empowering Healthy Behaviour, Department of Health Innovations and Technology, Fontys University of Applied Sciences, Eindhoven, Netherlands.'}, {'ForeName': 'Martijn F', 'Initials': 'MF', 'LastName': 'Pisters', 'Affiliation': 'Research Group Empowering Healthy Behaviour, Department of Health Innovations and Technology, Fontys University of Applied Sciences, Eindhoven, Netherlands.'}, {'ForeName': 'Corelien Jj', 'Initials': 'CJ', 'LastName': 'Kloek', 'Affiliation': 'Center for Physical Therapy Research and Innovation in Primary Care, Julius Health Care Centers, Utrecht, Netherlands.'}, {'ForeName': 'Remco M', 'Initials': 'RM', 'LastName': 'Arensman', 'Affiliation': 'Center for Physical Therapy Research and Innovation in Primary Care, Julius Health Care Centers, Utrecht, Netherlands.'}, {'ForeName': 'Raymond Wjg', 'Initials': 'RW', 'LastName': 'Ostelo', 'Affiliation': 'Department of Health Sciences, Faculty of Science, VU University Amsterdam, Amsterdam Movement Sciences research institute Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Veenhof', 'Affiliation': 'Center for Physical Therapy Research and Innovation in Primary Care, Julius Health Care Centers, Utrecht, Netherlands.'}]",Journal of medical Internet research,['10.2196/31675']
2515,35213496,Impact of the Deep Neuromuscular Block on Oncologic Quality of Laparoscopic Surgery in Obese Gastric Cancer Patients: A Randomized Clinical Trial.,"BACKGROUND


Obesity can hinder laparoscopic procedures and impede oncological safety during laparoscopic cancer surgery. Deep neuromuscular block (NMB) reportedly improves laparoscopic surgical conditions, but its oncological benefits are unclear. We aimed to evaluate whether deep NMB improves the oncologic quality of laparoscopic cancer surgery in obese patients.
STUDY DESIGN


We conducted a double-blinded, parallel-group, randomized, phase 3 trial at 9 institutions in Korea. Clinical stage I and II gastric cancer patients with a BMI at or above 25 kg m -2 were eligible and randomized 1:1 ratio to the deep or moderate NMB groups, with continuous infusion of rocuronium (0.5-1.0 and 0.1-0.5 mg kg -1 h -1, respectively). The primary endpoint was the number of retrieved lymph nodes (LNs). The secondary endpoints included the surgeon's surgical rating score (SRS) and interrupted events.
RESULTS


Between August 2017 and July 2020, 196 patients were enrolled. Fifteen patients were excluded, and 181 patients were finally included in the study. There was no significant difference in the number of retrieved LNs between the deep (N = 88) and moderate NMB groups (N = 93; 44.6 ± 17.5 vs 41.5 ± 16.9, p = 0.239). However, deep NMB enabled retrieving more LNs in patients with a BMI at or above 28 kg/m2 than moderate NMB (49.2 ± 18.6 vs 39.2 ± 13.3, p = 0.026). Interrupted events during surgery were lower in the deep NMB group than in the moderate NMB group (21.6% vs 36.6%; p = 0.034). The SRS was not influenced by NMB depth.
CONCLUSION


Deep NMB provides potential oncologic benefits by retrieving more LNs in patients with BMI at or above 28 kg/m2 during laparoscopic gastrectomy.",2022,"There was no significant difference in the number of retrieved LNs between the deep (N = 88) and moderate NMB groups (N = 93; 44.6 ± 17.5 vs 41.5 ± 16.9, p = 0.239).","['patients with BMI at or above 28 kg/m2 during laparoscopic gastrectomy', 'Between August 2017 and July 2020, 196 patients were enrolled', '9 institutions in Korea', 'Clinical stage I and II gastric cancer patients with a BMI at or above 25 kg m -2', 'Obese Gastric Cancer Patients', 'obese patients', 'laparoscopic cancer surgery', 'Fifteen patients were excluded, and 181 patients were finally included in the study']","['Deep Neuromuscular Block', 'Laparoscopic Surgery', 'deep NMB', 'Deep neuromuscular block (NMB', 'rocuronium', 'laparoscopic cancer surgery']","['oncologic quality', 'number of retrieved lymph nodes (LNs', 'Oncologic Quality', 'number of retrieved LNs', ""surgeon's surgical rating score (SRS) and interrupted events""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0205564', 'cui_str': 'Clinical stage I'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0023374', 'cui_str': 'Lesch-Nyhan syndrome'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",196.0,0.562833,"There was no significant difference in the number of retrieved LNs between the deep (N = 88) and moderate NMB groups (N = 93; 44.6 ± 17.5 vs 41.5 ± 16.9, p = 0.239).","[{'ForeName': 'Shin-Hoo', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'From the Division of Foregut Surgery, Department of Surgery, Korea University College of Medicine, Seoul, Republic of Korea (SH Park, JH Kim, CM Lee, S Park).'}, {'ForeName': 'Hyub', 'Initials': 'H', 'LastName': 'Huh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine (Huh), Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Il', 'Initials': 'SI', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery (Choi), Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.'}, {'ForeName': 'Jong-Han', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'From the Division of Foregut Surgery, Department of Surgery, Korea University College of Medicine, Seoul, Republic of Korea (SH Park, JH Kim, CM Lee, S Park).'}, {'ForeName': 'You-Jin', 'Initials': 'YJ', 'LastName': 'Jang', 'Affiliation': 'Division of Foregut Surgery, Department of Surgery, Korea University Guro Hospital, Seoul, Republic of Korea (JH Kim, Jang).'}, {'ForeName': 'Joong-Min', 'Initials': 'JM', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Chung-Ang University College of Medicine, Republic of Korea (JM Park).'}, {'ForeName': 'Oh Kyoung', 'Initials': 'OK', 'LastName': 'Kwon', 'Affiliation': 'Department of Surgery, School of Medicine, Kyungpook National University, Daegu, Republic of Korea (Kyoung Kwon).'}, {'ForeName': 'Mi Ran', 'Initials': 'MR', 'LastName': 'Jung', 'Affiliation': 'Department of Surgery, Chonnam National University Medical School, Jeollanam-do, Republic of Korea (Ran Jung, Jeong).'}, {'ForeName': 'Oh', 'Initials': 'O', 'LastName': 'Jeong', 'Affiliation': 'Department of Surgery, Chonnam National University Medical School, Jeollanam-do, Republic of Korea (Ran Jung, Jeong).'}, {'ForeName': 'Chang Min', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'From the Division of Foregut Surgery, Department of Surgery, Korea University College of Medicine, Seoul, Republic of Korea (SH Park, JH Kim, CM Lee, S Park).'}, {'ForeName': 'Jae Seok', 'Initials': 'JS', 'LastName': 'Min', 'Affiliation': 'Department of Surgery, Dongnam Institute of Radiological and Medical Sciences, Cancer Center, Busan, Republic of Korea (Seok Min).'}, {'ForeName': 'Jin-Jo', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': ""Department of Surgery, Incheon St. Mary's Hospital, The Catholic University of Korea College of Medicine, Incheon, Republic of Korea (JJ Kim).""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'An', 'Affiliation': 'Shaoxing Hospital Zhejiang University School of Medicine, Shaoxing, China (An).'}, {'ForeName': 'Kyung Sook', 'Initials': 'KS', 'LastName': 'Yang', 'Affiliation': 'Department of Biostatistics, Korea University College of Medicine, Seoul, Republic of Korea (Sook Yang).'}, {'ForeName': 'Sungsoo', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'From the Division of Foregut Surgery, Department of Surgery, Korea University College of Medicine, Seoul, Republic of Korea (SH Park, JH Kim, CM Lee, S Park).'}, {'ForeName': 'Il Ok', 'Initials': 'IO', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, Seoul, Republic of Korea (IO Lee).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Surgeons,['10.1097/XCS.0000000000000061']
2516,35213488,"Novel Way to Improve Satisfaction, Comprehension, and Anxiety in Caregivers: A Randomized Trial Exploring the Use of Comprehensive, Illustrated Children's Books for Pediatric Surgical Populations.","BACKGROUND


Surgery generates anxiety and stress, which can negatively impact informed consent and postoperative outcomes. This study assessed whether educational, illustrated children's books improve comprehension, satisfaction, and anxiety of caregivers in pediatric surgical populations.
METHODS


A prospective randomized trial was initiated at a tertiary care children's hospital. All patients ≤ 18 years old with caregiver and diagnosis of 1) uncomplicated appendicitis (English or Spanish speaking); 2) ruptured appendicitis; 3) pyloric stenosis; 4) need for gastrostomy tube; or 5) umbilical hernia were eligible. Conventional consent was obtained followed by completion of 17 validated survey questions addressing apprehension, satisfaction, and comprehension. Randomization (2:1) occurred after consent and before operative intervention with the experimental group (EG) receiving an illustrated comprehensive children's book outlining anatomy, pathophysiology, hospital course, and postoperative care. A second identical survey was completed before discharge. Primary outcomes were caregiver apprehension, satisfaction, and comprehension.
RESULTS


Eighty caregivers were included (55: EG, 25: control group [CG]). There were no significant differences in patient or caregiver demographics between groups. The baseline survey demonstrated no difference in comprehension, satisfaction, or apprehension between groups (all p values NS). After intervention, EG had significant improvement in 14 of 17 questions compared with CG (all p < 0.05). When tabulated by content, there was significant improvement in comprehension (p = 0.0009), satisfaction (p < 0.0001), and apprehension (p < 0.0001).
CONCLUSION


The use of illustrated educational children's books to explain pathophysiology and surgical care is a novel method to improve comprehension, satisfaction, and anxiety of caregivers. This could benefit informed consent, understanding, and postoperative outcomes.",2022,"After intervention, EG had significant improvement in 14 of 17 questions compared with CG (all p < 0.05).","['Eighty caregivers were included (55: EG, 25: control group [CG', 'All patients ≤ 18 years old with caregiver and diagnosis of 1) uncomplicated appendicitis (English or Spanish speaking); 2) ruptured appendicitis', 'Caregivers', ""Illustrated Children's Books for Pediatric Surgical Populations"", ""tertiary care children's hospital""]",['gastrostomy tube; or 5) umbilical hernia'],"['satisfaction', 'comprehension', 'Satisfaction, Comprehension, and Anxiety', 'patient or caregiver demographics', 'caregiver apprehension, satisfaction, and comprehension', 'comprehension, satisfaction, and anxiety of caregivers', 'comprehension, satisfaction, or apprehension']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0854119', 'cui_str': 'Appendicitis perforated'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0150595', 'cui_str': 'Gastrostomy tube'}, {'cui': 'C0019322', 'cui_str': 'Umbilical hernia'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0233485', 'cui_str': 'Apprehension'}]",80.0,0.0721906,"After intervention, EG had significant improvement in 14 of 17 questions compared with CG (all p < 0.05).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Baimas-George', 'Affiliation': 'From the Carolinas Medical Center, Department of Surgery, Charlotte, NC (Baimas-George, Watson, Paton, Matthews).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Watson', 'Affiliation': 'From the Carolinas Medical Center, Department of Surgery, Charlotte, NC (Baimas-George, Watson, Paton, Matthews).'}, {'ForeName': 'B Lauren', 'Initials': 'BL', 'LastName': 'Paton', 'Affiliation': 'From the Carolinas Medical Center, Department of Surgery, Charlotte, NC (Baimas-George, Watson, Paton, Matthews).'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Cosper', 'Affiliation': ""Levine Children's Hospital, Pediatric Surgical Associates, Charlotte, NC (Cosper, Schmelzer, Schulman, Bambini).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schmelzer', 'Affiliation': ""Levine Children's Hospital, Pediatric Surgical Associates, Charlotte, NC (Cosper, Schmelzer, Schulman, Bambini).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Schulman', 'Affiliation': ""Levine Children's Hospital, Pediatric Surgical Associates, Charlotte, NC (Cosper, Schmelzer, Schulman, Bambini).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bambini', 'Affiliation': ""Levine Children's Hospital, Pediatric Surgical Associates, Charlotte, NC (Cosper, Schmelzer, Schulman, Bambini).""}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Matthews', 'Affiliation': 'From the Carolinas Medical Center, Department of Surgery, Charlotte, NC (Baimas-George, Watson, Paton, Matthews).'}]",Journal of the American College of Surgeons,['10.1097/XCS.0000000000000057']
2517,35215483,"The Combination of School-Based and Family-Based Interventions Appears Effective in Reducing the Consumption of Sugar-Sweetened Beverages, a Randomized Controlled Trial among Chinese Schoolchildren.","To examine whether environmental interventions, student awareness and parents' model roles are associated with the consumption of sugar-sweetened beverages (SSBs), a randomized controlled trial was conducted among Chinese schoolchildren. A multi-stage cluster random sampling method was applied to select four primary schools, two in urban areas and two in rural areas, in Nanjing, eastern China. Classes of the third grade in the selected four schools were randomly assigned to the intervention group and control group. Among selected students in those classes, aged 9-10 years, those in the intervention group received intervention measures comprising school-based and family-based measures and accepted monthly monitoring along with interventions, for two consecutive semesters, while those in the control group did not receive any specific interventions. After intervention, there was a significant increase in SSB knowledge and an improvement in the family environment with parents in the intervention group. The proportion of frequent consumption (≥4 times/week) of any SSBs in the intervention group was lower than that in the control group (31.5% vs. 56.2%,  p  < 0.01). Multivariate analysis indicated that parental education level is positively associated with reduced SSB consumption. Interventions showed an average decrease in SSBs consumption by 1.77 units, those living in urban areas decreased by 2.05 units. The combination of school-based and family-based interventions appears effective in reducing SSB consumption among Chinese schoolchildren, especially in urban areas and for those with parents with lower educational levels.",2022,"The combination of school-based and family-based interventions appears effective in reducing SSB consumption among Chinese schoolchildren, especially in urban areas and for those with parents with lower educational levels.","['selected students in those classes, aged 9-10 years, those in the intervention group received', 'four primary schools, two in urban areas and two in rural areas, in Nanjing, eastern China', 'Chinese schoolchildren', 'Chinese Schoolchildren', 'Classes of the third grade in the selected four schools']","['School-Based and Family-Based Interventions', 'intervention measures comprising school-based and family-based measures and accepted monthly monitoring along with interventions, for two consecutive semesters, while those in the control group did not receive any specific interventions', 'school-based and family-based interventions']","['SSB consumption', 'SSBs consumption', 'SSB knowledge', 'proportion of frequent consumption']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]",4.0,0.0175393,"The combination of school-based and family-based interventions appears effective in reducing SSB consumption among Chinese schoolchildren, especially in urban areas and for those with parents with lower educational levels.","[{'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Non-Communicable Disease Prevention, Nanjing Municipal Center for Disease Control and Prevention, Nanjing 210003, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'Department of Non-Communicable Disease Prevention, Nanjing Municipal Center for Disease Control and Prevention, Nanjing 210003, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Non-Communicable Disease Prevention, Nanjing Municipal Center for Disease Control and Prevention, Nanjing 210003, China.'}, {'ForeName': 'Hairong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Non-Communicable Disease Prevention, Nanjing Municipal Center for Disease Control and Prevention, Nanjing 210003, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Non-Communicable Disease Prevention, Nanjing Municipal Center for Disease Control and Prevention, Nanjing 210003, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Non-Communicable Disease Prevention, Nanjing Municipal Center for Disease Control and Prevention, Nanjing 210003, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Department of Non-Communicable Disease Prevention, Nanjing Municipal Center for Disease Control and Prevention, Nanjing 210003, China.'}, {'ForeName': 'Jinkou', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Non-Communicable Disease Prevention, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China.'}]",Nutrients,['10.3390/nu14040833']
2518,35215467,Community Perceptions of Zinc Biofortified Flour during an Intervention Study in Pakistan.,"Zinc-biofortified flour may be a cost-effective approach to improve zinc status of populations in low-resource settings. The success of biofortification programmes is subject to acceptability and uptake by consumers. This study explored community leaders' and community members' ( n  = 72) experiences and attitudes towards the flour provided during a cluster randomised controlled trial of zinc biofortified wheat in rural Pakistan (BiZiFED2). Focus group discussions ( n  = 12) were conducted and thematic analysis applied using an inductive, semantic, contextualist approach. Five themes were identified: (1) Contribution to food security; (2) Better sensory and baking properties than local flour; (3) Perceived health benefits; (4) Willingness to pay for the flour; and (5) Importance of trusted promoters/suppliers. Although the participants were blind to whether they had received control or biofortified flour, referred to collectively as ""study flour"", the results indicated that the study flour performed well in terms of its taste and bread making qualities, with no adverse reports from participants in either arm of the BIZIFED2 RCT. Participants suggested that they would buy the biofortified wheat if this was available at a fair price due to perceived health benefits, reporting positive sensory characteristics and cooking attributes when compared to the flour available in the local markets. Overall, there was a positive reception of the programme and flour among the participants, and members of the community hoped for its continuation and expansion.",2022,"Overall, there was a positive reception of the programme and flour among the participants, and members of the community hoped for its continuation and expansion.","[""community leaders' and community members' ( n  = 72) experiences and attitudes towards the flour provided during a cluster randomised controlled trial of zinc biofortified wheat in rural Pakistan (BiZiFED2"", 'Pakistan']","['control or biofortified flour', 'Zinc-biofortified flour', 'Zinc Biofortified Flour']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]",[],5.0,0.175954,"Overall, there was a positive reception of the programme and flour among the participants, and members of the community hoped for its continuation and expansion.","[{'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Mahboob', 'Affiliation': 'Institute of Health Professions Education and Research, Khyber Medical University, Peshawar 25100, Pakistan.'}, {'ForeName': 'Marena', 'Initials': 'M', 'LastName': 'Ceballos-Rasgado', 'Affiliation': 'Centre for Global Development, University of Central Lancashire, Preston PR1 2HE, UK.'}, {'ForeName': 'Victoria Hall', 'Initials': 'VH', 'LastName': 'Moran', 'Affiliation': 'Centre for Global Development, University of Central Lancashire, Preston PR1 2HE, UK.'}, {'ForeName': 'Edward J M', 'Initials': 'EJM', 'LastName': 'Joy', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ohly', 'Affiliation': 'Centre for Global Development, University of Central Lancashire, Preston PR1 2HE, UK.'}, {'ForeName': 'Mukhtiar', 'Initials': 'M', 'LastName': 'Zaman', 'Affiliation': 'Department of Pulmonology, Rehman Medical Institute, Peshawar 25000, Pakistan.'}, {'ForeName': 'Nicola M', 'Initials': 'NM', 'LastName': 'Lowe', 'Affiliation': 'Centre for Global Development, University of Central Lancashire, Preston PR1 2HE, UK.'}]",Nutrients,['10.3390/nu14040817']
2519,35215466,Effect of Morning and Evening Exercise on Energy Balance: A Pilot Study.,"The purpose of this study was to evaluate the feasibility and acceptability of randomizing adults with overweight and obesity (BMI 25-40 kg/m 2 ) to morning (06:00-10:00) or evening (15:00-19:00) aerobic exercise. Participants completed four exercise sessions per week in the morning (AM,  n  = 18) or evening (PM,  n  = 15). The exercise program was 15 weeks and progressed from 70 to 80% heart rate maximum and 750-2000 kcal/week. Bodyweight, body composition, total daily energy expenditure (TDEE), energy intake (EI), sleep, sedentary behavior (SB), non-exercise physical activity (NEPA), and maximal aerobic capacity were assessed at baseline and week 15. Study retention was 94% and adherence to the supervised exercise program was ≥90% in both groups. Weight change was -0.9 ± 2.8 kg and -1.4 ± 2.3 kg in AM and PM, respectively. AM and PM increased TDEE (AM: 222 ± 399 kcal/day, PM: 90 ± 150 kcal/day). EI increased in AM (99 ± 198 kcal/day) and decreased in PM (-21 ± 156 kcal/day) across the intervention. It is feasible to randomize adults with overweight and obesity to morning or evening aerobic exercise with high levels of adherence. Future trials are needed to understand how the timing of exercise affects energy balance and body weight regulation.",2022,"AM and PM increased TDEE (AM: 222 ± 399 kcal/day, PM: 90 ± 150 kcal/day).",['randomizing adults with overweight and obesity (BMI 25-40 kg/m 2 ) to morning (06:00-10:00) or'],"['Morning and Evening Exercise', 'evening (15:00-19:00) aerobic exercise']","['Weight change', 'Energy Balance', 'EI increased in AM', 'Bodyweight, body composition, total daily energy expenditure (TDEE), energy intake (EI), sleep, sedentary behavior (SB), non-exercise physical activity (NEPA), and maximal aerobic capacity', 'feasibility and acceptability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332170', 'cui_str': 'Morning'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.017146,"AM and PM increased TDEE (AM: 222 ± 399 kcal/day, PM: 90 ± 150 kcal/day).","[{'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Creasy', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Wayland', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Shelby L', 'Initials': 'SL', 'LastName': 'Panter', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Purcell', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Rosenberg', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion Disease Prevention, University of North Carolina-Chapel Hill, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Bethelhem', 'Initials': 'B', 'LastName': 'Shiferaw', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Grau', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Breit', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Catenacci', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}]",Nutrients,['10.3390/nu14040816']
2520,35215461,Be Healthy in Pregnancy (BHIP): A Randomized Controlled Trial of Nutrition and Exercise Intervention from Early Pregnancy to Achieve Recommended Gestational Weight Gain.,"A randomized two-arm prospective superiority trial tested the efficacy of a novel structured and monitored nutrition (bi-weekly counselling for individualized energy and high dairy protein diet) and exercise program (walking goal of 10,000 steps/day) (intervention) compared to usual care (control) in pregnant women to achieve gestational weight gain (GWG) within current recommendations. Women recruited in communities in southern Ontario, Canada were randomized at 12-17 weeks gestation with stratification by site and pre-pregnancy BMI to intervention ( n  = 119) or control ( n  = 122). The primary outcome was the proportion of women who achieved GWG within the Institute of Medicine recommendations. Although the intervention compared to control group was more likely to achieve GWG within recommendations (OR = 1.51; 95% CI (0.81, 2.80)) and total GWG was lower by 1.45 kg (95% CI: (-11.9, 8.88)) neither reached statistical significance. The intervention group achieved significantly higher protein intake at 26-28 week (mean difference (MD); 15.0 g/day; 95% CI (8.1, 21.9)) and 36-38 week gestation (MD = 15.2 g/day; 95% CI (9.4, 21.1)) and higher healthy diet scores (22.5 ± 6.9 vs. 18.7 ± 8.5,  p  < 0.005) but step counts were similar averaging 6335 steps/day. Pregnancy and infant birth outcomes were similar between groups. While the structured and monitored nutrition with counselling improved diet quality and protein intake and may have benefited GWG, the exercise goal of 10,000 steps/day was unachievable. The results can inform future recommendations for diet and physical activity in pregnancy.",2022,"Although the intervention compared to control group was more likely to achieve GWG within recommendations (OR = 1.51; 95% CI (0.81, 2.80)) and total GWG was lower by 1.45 kg (95% CI: (-11.9, 8.88)) neither reached statistical significance.","['Women recruited in communities in southern Ontario, Canada were randomized at 12-17 weeks gestation with stratification by site and pre-pregnancy BMI to intervention ( n  = 119) or control ( n  = 122', 'Be Healthy in Pregnancy (BHIP', 'pregnant women to achieve gestational weight gain (GWG) within current recommendations']","['novel structured and monitored nutrition (bi-weekly counselling for individualized energy and high dairy protein diet) and exercise program (walking goal of 10,000 steps/day) (intervention) compared to usual care (control', 'Nutrition and Exercise Intervention']","['healthy diet scores', 'higher protein intake', 'diet quality and protein intake', 'proportion of women who achieved GWG', 'Pregnancy and infant birth outcomes', 'Gestational Weight Gain', 'total GWG']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0452269', 'cui_str': 'Protein diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.026977,"Although the intervention compared to control group was more likely to achieve GWG within recommendations (OR = 1.51; 95% CI (0.81, 2.80)) and total GWG was lower by 1.45 kg (95% CI: (-11.9, 8.88)) neither reached statistical significance.","[{'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Atkinson', 'Affiliation': 'Department of Pediatrics, McMaster University, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Atherai', 'Initials': 'A', 'LastName': 'Maran', 'Affiliation': 'Department of Pediatrics, McMaster University, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Dempsey', 'Affiliation': 'Department of Pediatrics, McMaster University, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Maude', 'Initials': 'M', 'LastName': 'Perreault', 'Affiliation': 'Department of Pediatrics, McMaster University, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Thuva', 'Initials': 'T', 'LastName': 'Vanniyasingam', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Eileen K', 'Initials': 'EK', 'LastName': 'Hutton', 'Affiliation': 'Midwifery Research Centre, McMaster University, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Michelle F', 'Initials': 'MF', 'LastName': 'Mottola', 'Affiliation': 'Department of Anatomy & Cell Biology, School of Kinesiology, University of Western Ontario, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Olive', 'Initials': 'O', 'LastName': 'Wahoush', 'Affiliation': 'School of Nursing, McMaster University, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON L8S 4K1, Canada.'}]",Nutrients,['10.3390/nu14040810']
2521,35215544,"Effect of a Four-Week Vegan Diet on Performance, Training Efficiency and Blood Biochemical Indices in CrossFit-Trained Participants.","This interventional study examined the effect of a four-week vegan diet (Veg D ) during a four-week high-intensity functional training (HIFT) on performance, training results and blood biochemical indices in female ( n  = 12) and male ( n  = 8) moderate-trained CrossFit participants. The whole study group performed the maximum number of repetitions with a load of 70% one repetition-maximum (1RM) and a modified Fight Gone Bad (FGB Mod ) test before and after a dietary intervention (the group was divided to follow a Veg D  or a traditional mixed diet (Mix D )) in a randomised and parallel design. Pre-exercise resting blood samples were also analysed. There was a significant improvement in the number of repetitions performed at a load corresponding to 70% of 1RM in the classic squat in the Mix D  group ( p  < 0.001), and in the classic deadlift in the Veg D  group ( p  = 0.014). Furthermore, there was a significant improvement in the results of the FGB Mod  performance test after a Mix D . Moreover, an improvement in some exercises in the modified FGB Mod  test (Wall Ball after the Veg D  and the Mix D , and rowing after the Mix D ) was also observed. However, differences between the Mix D  and the Veg D  groups were not clinically relevant. In conclusion, the short-term study conducted here indicated that a Veg D  in HIFT training positively affects strength endurance in the classic deadlift but is unlikely to be more beneficial in improving performance than a Mix D .",2022,"There was a significant improvement in the number of repetitions performed at a load corresponding to 70% of 1RM in the classic squat in the Mix D  group ( p  < 0.001), and in the classic deadlift in the Veg D  group ( p  = 0.014).","['CrossFit-Trained Participants', 'female ( n  = 12) and male ( n  = 8) moderate-trained CrossFit participants']","['Four-Week Vegan Diet', 'four-week vegan diet (Veg D ) during a four-week high-intensity functional training (HIFT', 'maximum number of repetitions with a load of 70% one repetition-maximum (1RM) and a modified Fight Gone Bad (FGB Mod ) test before and after a dietary intervention (the group was divided to follow a Veg D  or a traditional mixed diet (Mix D ']","['strength endurance', 'Performance, Training Efficiency and Blood Biochemical Indices', 'number of repetitions']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0344353', 'cui_str': 'Vegan'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0424324', 'cui_str': 'Fighting'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",,0.0163328,"There was a significant improvement in the number of repetitions performed at a load corresponding to 70% of 1RM in the classic squat in the Mix D  group ( p  < 0.001), and in the classic deadlift in the Veg D  group ( p  = 0.014).","[{'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Durkalec-Michalski', 'Affiliation': 'Department of Sports Dietetics, Poznań University of Physical Education, 61-871 Poznan, Poland.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Domagalski', 'Affiliation': 'Home of Body Training Studio, AFB Marcelin Sp. z o.o, 60-324 Poznan, Poland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Główka', 'Affiliation': 'Department of Sports Dietetics, Poznań University of Physical Education, 61-871 Poznan, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Kamińska', 'Affiliation': 'Department of Physiology and Biochemistry, Poznań University of Physical Education, 61-871 Poznan, Poland.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Szymczak', 'Affiliation': 'Home of Body Training Studio, AFB Marcelin Sp. z o.o, 60-324 Poznan, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Podgórski', 'Affiliation': 'Department of Physiology and Biochemistry, Poznań University of Physical Education, 61-871 Poznan, Poland.'}]",Nutrients,['10.3390/nu14040894']
2522,35215537,Effect of Dietary Glycemic Index on β-Cell Function in Prediabetes: A Randomized Controlled Feeding Study.,"The glycemic index (GI) reflects the relative ability of carbohydrates to raise blood glucose. We utilized a controlled feeding study to assess the impact of the dietary GI on β-cell function in adults with prediabetes (17F/18M, mean ± SEM: BMI 32.44 ± 0.94 kg/m 2 , age 54.2 ± 1.57 years). Following a 2 week Control diet (GI = 55-58), participants were randomized to either a 4 week low GI (LGI: GI < 35, n = 17) or high GI (HGI: GI > 70, n = 18) diet (55% of energy from carbohydrate/30% fat/15% protein). The data from 4 h meal tolerance tests (MTTs) underwent mathematical modeling to assess insulin sensitivity, insulin secretion and β-cell function. Glucose concentrations during the MTT decreased on the LGI diet ( p  < 0.001) and trended to increase on the HGI diet ( p  = 0.14; LGI vs. HGI  p  < 0.001), with parallel changes in insulin and C-peptide concentrations. Total insulin secretion, adjusted for glucose and insulin sensitivity, increased on the LGI diet ( p  = 0.002), and trended lower on the HGI diet ( p  = 0.10; LGI vs. HGI  p  = 0.001). There was no significant diet effect on insulin sensitivity or other measures of β-cell function. Total insulin clearance increased on the LGI diet ( p  = 0.01; LGI vs. HGI  p  < 0.001). We conclude that short-term consumption of an LGI diet reduced glucose exposure and insulin secretion but had no impact on measures of β-cell function.",2022,"Total insulin secretion, adjusted for glucose and insulin sensitivity, increased on the LGI diet ( p  = 0.002), and trended lower on the HGI diet ( p  = 0.10; LGI vs. HGI  p  = 0.001).","['adults with prediabetes (17F/18M, mean ± SEM: BMI 32.44 ± 0.94 kg/m 2 , age 54.2 ± 1.57 years', 'Prediabetes']","['4 week low GI (LGI: GI < 35, n = 17) or high GI (HGI', 'dietary GI', 'Dietary Glycemic Index']","['Total insulin clearance', 'Glucose concentrations', 'glycemic index (GI', 'HGI diet', 'insulin sensitivity, insulin secretion and β-cell function', 'glucose exposure and insulin secretion', 'insulin sensitivity', 'Total insulin secretion, adjusted for glucose and insulin sensitivity', 'β-cell function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517487', 'cui_str': '0.94'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517808', 'cui_str': '54.2'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}]",,0.0809158,"Total insulin secretion, adjusted for glucose and insulin sensitivity, increased on the LGI diet ( p  = 0.002), and trended lower on the HGI diet ( p  = 0.10; LGI vs. HGI  p  = 0.001).","[{'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Sipe', 'Affiliation': 'Creighton University School of Medicine, Omaha, NE 68124, USA.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Breymeyer', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'Research and Development, Department of Medicine, VA Puget Sound Health Care System, Seattle, WA 98108, USA.'}]",Nutrients,['10.3390/nu14040887']
2523,35215525,Carbohydrate Mouth Rinse Increases High but Not Low Intensity Repetitions to Failure in Resistance-Trained Males.,"Carbohydrate mouth rinsing (CMR) has been shown to enhance exercise performance. However, the influence of CMR on repetitions to failure with different intensities (40% or 80% of 1 RM) is unknown. Therefore, the purpose of this study was to examine the effects of a 6% CMR solution on muscular endurance assessed at 40% and 80% of 1 RM in resistance-trained males. Sixteen resistance-trained males (age: 25 ± 3 years, height: 182 ± 6 cm, body mass: 86 ± 3 kg, body fat: 16 ± 3%, bench press 1 RM: 106 ± 16 kg, resistance training experience: 5 ± 1 years) completed four conditions in random order. The four conditions consisted of ten seconds of mouth rinsing with 25 mL solutions containing either maltodextrin or placebo (sweetened water) prior to performing a bench press muscular endurance test at either 40% of 1 RM or 80% of 1 RM. Total repetitions, heart rate (HR), ratings of perceived exertion (RPE), glucose (GLU) and felt arousal (FA) were recorded for each condition. There was a significant condition by intensity interaction ( p  = 0.02). CMR significantly increased total repetitions compared with placebo at the higher intensity (80% of 1 RM;  p  = 0.04), while there was no effect at the lower intensity ( p  = 0.20). In addition, HR, RPE, GLU and FA did not differ between conditions or across intensities ( p  > 0.05). In conclusion, CMR-enhanced muscular endurance performed at higher but not lower intensities.",2022,"CMR significantly increased total repetitions compared with placebo at the higher intensity (80% of 1 RM;  p  = 0.04), while there was no effect at the lower intensity ( p  = 0.20).","['resistance-trained males', 'Sixteen resistance-trained males (age: 25 ± 3 years, height: 182 ± 6 cm, body mass: 86 ± 3 kg, body fat: 16 ± 3%, bench press 1 RM: 106 ± 16 kg, resistance training experience: 5 ± 1 years) completed four conditions in random order']","['placebo', 'CMR', 'CMR solution', 'maltodextrin or placebo', 'Carbohydrate mouth rinsing (CMR', 'Carbohydrate Mouth Rinse']","['Total repetitions, heart rate (HR), ratings of perceived exertion (RPE), glucose (GLU) and felt arousal (FA', 'total repetitions', 'HR, RPE, GLU and FA', 'muscular endurance', 'CMR-enhanced muscular endurance']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}]",,0.0559196,"CMR significantly increased total repetitions compared with placebo at the higher intensity (80% of 1 RM;  p  = 0.04), while there was no effect at the lower intensity ( p  = 0.20).","[{'ForeName': 'Raci', 'Initials': 'R', 'LastName': 'Karayigit', 'Affiliation': 'Faculty of Sport Sciences, Ankara University, Gölbaşı, Ankara 06830, Turkey.'}, {'ForeName': 'Mustafa Can', 'Initials': 'MC', 'LastName': 'Eser', 'Affiliation': 'Faculty of Sport Sciences, Ankara University, Gölbaşı, Ankara 06830, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Gur', 'Affiliation': 'Faculty of Sport Sciences, Pamukkale University, Pamukkale, Denizli 20000, Turkey.'}, {'ForeName': 'Cengizhan', 'Initials': 'C', 'LastName': 'Sari', 'Affiliation': 'Faculty of Sport Sciences, Muş Alparslan University, Muş 49250, Turkey.'}, {'ForeName': 'Ladislav', 'Initials': 'L', 'LastName': 'Cepicka', 'Affiliation': 'Sport Centrum Faculty of Pedagogy, University of West Bohemia, 301 00 Pilsen, Czech Republic.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Gabrys', 'Affiliation': 'Sport Centrum Faculty of Pedagogy, University of West Bohemia, 301 00 Pilsen, Czech Republic.'}]",Nutrients,['10.3390/nu14040875']
2524,35215521,"Dietary Intervention Effectiveness, Clinical Outcomes and Nutrient and Salicylate Intakes in Older Adults Living in Long-Term Care Homes: The Results from the Senior's Plate Project.","Optimal nutrition is an important part of the therapeutic process offered to patients in long-term care, as it can significantly influence their nutritional and health status. The aim of this study was to assess the impacts of a dietary intervention on the nutritional status, clinical outcomes and selected nutrient and salicylate intakes among older adults living in a long-term care nursing home. To achieve the research goal, a prospective, non-randomized, baseline-controlled intervention study was conducted. The study was conducted within the framework of the ""Senior's Plate Project"", a project established in 2018 by the Polish Society of Dietetics.
METHODS


A 3 month dietary intervention, which included one serving of supplementary food, served as a second breakfast (Nestle Sinlac). Energy, nutrients and salicylates intakes were estimated on the basis of the menus. Food and beverage intakes among residents were verified by health care personnel. Anthropometric measurements and clinical examinations were conducted according to standard procedures at baseline and after intervention.
RESULTS


Of the 38 residents qualified for the study, 29 completed the program. Residents' body mass index (BMI) values ranged from 13.3 kg/m 2  to 34 kg/m 2 . A BMI < 22 kg/m 2 , indicating underweight, was found in 19 subjects. The dietary intervention resulted in increased body weight (57.8 ± 12.3 vs. 59.4 ± 12.6 kg), BMI (22.4 ± 4.0 vs. 23.0 ± 4.1 kg/m 2 ) and body fat (19.2 ± 8.7 vs. 20.6 ± 8.9 kg). Significant changes in the levels of biochemical parameters, including serum calcium (8.7 vs. 9.5 mg/dL), potassium (4.1 ± 0.6 vs. 4.5 ± 0.5 mmol/L) and zinc (74.1 ± 10.9 vs. 109.0 ± 20.4 µg/dL), were observed. Energy, protein, fat and carbohydrate intakes were significantly higher in the third month of the intervention as compared to the baseline. The estimated medial daily intake of salicylates was low and ranged from 0.34 mg to 0.39 mg.
CONCLUSIONS


The dietary intervention resulted in beneficial and significant changes in the nutritional status, biochemical parameters and nutrition of residents of the long-term care home. These results suggest that practical and individualized approaches are required to improve the nutritional status and clinical outcomes of nursing homes residents.",2022,"Energy, protein, fat and carbohydrate intakes were significantly higher in the third month of the intervention as compared to the baseline.","['nursing homes residents', '38 residents qualified for the study, 29 completed the program', 'older adults living in a long-term care nursing home', 'Older Adults Living in Long-Term Care Homes']","['dietary intervention', 'Nutrient and Salicylate Intakes']","['Energy, nutrients and salicylates intakes', ""Residents' body mass index (BMI) values"", 'levels of biochemical parameters, including serum calcium', 'body weight', 'Energy, protein, fat and carbohydrate intakes', 'nutritional status, biochemical parameters and nutrition of residents of the long-term care home', 'estimated medial daily intake of salicylates']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0036075', 'cui_str': 'Salicylate'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0036075', 'cui_str': 'Salicylate'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0110954,"Energy, protein, fat and carbohydrate intakes were significantly higher in the third month of the intervention as compared to the baseline.","[{'ForeName': 'Danuta', 'Initials': 'D', 'LastName': 'Gajewska', 'Affiliation': 'Department of Dietetics, Institute of Human Nutrition Sciences, Warsaw University of Life Sciences (WULS), 159C Nowoursynowska Str, 02-776 Warsaw, Poland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Gosa', 'Affiliation': 'Department of Dietetics, Institute of Human Nutrition Sciences, Warsaw University of Life Sciences (WULS), 159C Nowoursynowska Str, 02-776 Warsaw, Poland.'}, {'ForeName': 'Paulina Katarzyna', 'Initials': 'PK', 'LastName': 'Kęszycka', 'Affiliation': 'Department of Dietetics, Institute of Human Nutrition Sciences, Warsaw University of Life Sciences (WULS), 159C Nowoursynowska Str, 02-776 Warsaw, Poland.'}]",Nutrients,['10.3390/nu14040871']
2525,35216560,"What is the effect of independent medical evaluation on days on sickness benefits for long-term sick listed employees in Norway? A pragmatic randomised controlled trial, the NIME-trial.","BACKGROUND


Independent medical evaluations are used to evaluate degree and reason for work disability, uncertainty around the functional status, and/or the employee's rehabilitation potential in several jurisdictions, but not in Norway. The main aim of this trial was to test the return to work effect of independent medical evaluation (IME) (summoning and consultation) compared to treatment as usual (TAU) in Norway, for workers who have been on continuous sick leave for 6 months.
METHODS


This was a pragmatic randomised controlled trial including all employees aged 18-65 years, sick-listed by their general practitioner and on full or partial sick leave for the past 26 weeks in Hordaland County, Norway in 2015/16. Trial candidates were drawn from a central register at the Norwegian Labour and Welfare Administration at 22 weeks of sick leave. Pregnant women, individuals with cancer or dementia diagnoses, those with secret address, employed by NAV or sick listed by the specialist health services were excluded. Separate regression analyses were conducted to investigate the ""intention-to-treat"" and ""treatment on the treated"" effects, using the ordinary least squares and instrumental variable methods, respectively.
RESULTS


After exemption based on predefined exclusion criteria, 5888 individuals were randomised to either IME (n = 2616) or TAU (n = 2599). The final intervention group constitutes 1698 individuals, of which 937 attended the IME consultation. No baseline differences were found between the IME and TAU group regarding gender, age, and previous sick leave. Individuals attending the IME were older than those who cancelled the appointment ((47/45), p = 0.006) and those who did not show up without cancelling ((47/42), p < 0.001). Mainly the IME physician agreed with the regular GP upon level of sick leave. In cases with different assessments, the difference tended to be towards a lower sick leave level. There were no intention to treat or treatment on the treated effect on days of sick leave after randomisation during follow up.
CONCLUSIONS


Overall, the analyses showed no effect of IME on changes in sick leave for sick listed employees. This result was consistent for those who were offered an IME consultation (intention to treat) and those who undertook an IME consultation (treatment on the treated).
TRIAL REGISTRATION


ClinicalTirals.gov trial number NCT02524392 first registration 14.08.2015.",2022,"There were no intention to treat or treatment on the treated effect on days of sick leave after randomisation during follow up.
","['usual (TAU) in Norway, for workers who have been on continuous sick leave for 6 months', '1698 individuals, of which 937 attended the IME consultation', 'all employees aged 18-65\u2009years, sick-listed by their general practitioner and on full or partial sick leave for the past 26\u2009weeks in Hordaland County, Norway in 2015/16', 'Pregnant women, individuals with cancer or dementia diagnoses, those with secret address, employed by NAV or sick listed by the specialist health services were excluded', 'Trial candidates were drawn from a central register at the Norwegian Labour and Welfare Administration at 22\u2009weeks of sick leave', '5888 individuals']","['IME', 'medical evaluation (IME) (summoning and consultation', 'TAU']",[],"[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4277662', 'cui_str': 'Independent Medical Examinations'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0574545', 'cui_str': 'Navajo language'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C4277662', 'cui_str': 'Independent Medical Examinations'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],5888.0,0.321701,"There were no intention to treat or treatment on the treated effect on days of sick leave after randomisation during follow up.
","[{'ForeName': 'Silje', 'Initials': 'S', 'LastName': 'Mæland', 'Affiliation': 'Research Unit for General Practice, NORCE Norwegian Research Centre, Bergen, Norway. silje.maeland@uib.no.'}, {'ForeName': 'Tor Helge', 'Initials': 'TH', 'LastName': 'Holmås', 'Affiliation': 'NORCE Norwegian Research Centre, Health and Social Sciences, Bergen, Norway.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Øyeflaten', 'Affiliation': 'NORCE Norwegian Research Centre, Health and Social Sciences, Bergen, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Husabø', 'Affiliation': 'RKBU West, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Erik L', 'Initials': 'EL', 'LastName': 'Werner', 'Affiliation': 'Department of General Practice, Institute of Health and Society, Faculty of medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Monstad', 'Affiliation': 'NORCE Norwegian Research Centre, Health and Social Sciences, Bergen, Norway.'}]",BMC public health,['10.1186/s12889-022-12800-1']
2526,35216556,Effect of growth hormone therapy on liver enzyme and other cardiometabolic risk factors in boys with obesity and nonalcoholic fatty liver disease.,"BACKGROUND


Non-alcoholic fatty liver disease (NAFLD) has become the most common causes of liver disease in children and adolescents. Although several reports have confirmed the significant correlation between NAFLD and growth hormone (GH)-insulin-like growth factor 1(IGF-1) axis, no study further investigates whether or not recombinant human GH (rhGH) treatment can improve NAFLD in obese children.
METHODS


This study was a randomized, open-label study comprising 44 boys with obesity and NAFLD (11.76 ± 1.67 year) to evaluate the effects of 6 months of rhGH administration for boys with obesity and NAFLD. The subjects were randomized divided into treatment group (subjects with recombinant human GH (rhGH)) and control group for 6 months.
RESULTS


After 6 months, IGF-1 increased significantly during rhGH treatment, in comparison with the control group (582.45 ± 133.00 vs. 359.64 ± 129.00 ng/ml; p < 0.001). A significant reduction in serum alanine aminotransferase(ALT) (15.00 vs. 28.00 U/L; p = 0.001), aspartate aminotransferase(AST) (20.00 vs. 24.50U/L; p = 0.004), gamma glutamyl transferase(GGT) (14.50 vs. 28.50 U/L; p < 0.001) was observed in the GH-treated boys. In addition, the rhGH group showed a significant decrease in C reactive protein (CRP) (1.17 ± 0.76 vs. 2.26 ± 1.43 mg/L) and body mass index standard deviation scores (BMI SDS) (2.28 ± 0.80 vs. 2.71 ± 0.61) than the control group (p = 0.003, p = 0.049 respectively). GH treatment also reduced low density lipoprotein cholesterol (LDL-C) (2.19 ± 0.42 vs. 2.61 ± 0.66 mmol/L; p = 0.016) and increased high density lipoprotein cholesterol (HDL-C) (1.30 vs. 1.15 mmol/L; p = 0.005), and there were no changes in total cholesterol (TC), triglycerides (TG) and uric acid(UA) between the treatment group and the control group.
CONCLUSION


Our findings suggest that 6 months treatment with rhGH may be beneficial for liver enzyme and can improve obesity-related other cardiovascular and metabolic complications in boys with obesity and NAFLD.",2022,"A significant reduction in serum alanine aminotransferase(ALT) (15.00 vs. 28.00 U/L; p = 0.001), aspartate aminotransferase(AST) (20.00 vs. 24.50U/L; p = 0.004), gamma glutamyl transferase(GGT) (14.50 vs. 28.50 U/L; p < 0.001) was observed in the GH-treated boys.","['children and adolescents', 'boys with obesity and nonalcoholic fatty liver disease', 'obese children', 'boys with obesity and NAFLD', '44 boys with obesity and NAFLD (11.76\u2009±\u20091.67\xa0year', 'for boys with obesity and NAFLD']","['rhGH', 'recombinant human GH (rhGH', 'rhGH administration', 'recombinant human GH (rhGH)) and control group for 6\xa0months', 'growth hormone therapy']","['low density lipoprotein cholesterol (LDL-C', 'serum alanine aminotransferase(ALT', 'body mass index standard deviation scores (BMI SDS', 'liver enzyme and other cardiometabolic risk factors', 'aspartate aminotransferase(AST', 'high density lipoprotein cholesterol (HDL-C', 'total cholesterol (TC), triglycerides (TG) and uric acid(UA', 'C reactive protein (CRP', 'gamma glutamyl transferase(GGT', 'IGF-1']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C4517511', 'cui_str': '1.67'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}]",44.0,0.0393366,"A significant reduction in serum alanine aminotransferase(ALT) (15.00 vs. 28.00 U/L; p = 0.001), aspartate aminotransferase(AST) (20.00 vs. 24.50U/L; p = 0.004), gamma glutamyl transferase(GGT) (14.50 vs. 28.50 U/L; p < 0.001) was observed in the GH-treated boys.","[{'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Xue', 'Affiliation': 'Department of Pediatrics, The Second Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Liang', 'Affiliation': 'Department of Pediatrics, The Second Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Yankuang New Journey General Hospital, Zoucheng, China.'}, {'ForeName': 'Yanfeng', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': ""Department of Pediatrics, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. 94602040@qq.com.""}]",BMC endocrine disorders,['10.1186/s12902-022-00967-y']
2527,35216555,Impact on routine psychiatric diagnostic practice from implementing the DSM-5 cultural formulation interview: a pragmatic RCT in Sweden.,"BACKGROUND


Culture and social context affect the expression and interpretation of symptoms of distress, raising challenges for transcultural psychiatric diagnostics. This increases the risk that mental disorders among migrants and ethnic minorities are undetected, diagnosed late or misdiagnosed. We investigated whether adding a culturally sensitive tool, the DSM-5 core Cultural Formulation Interview (CFI), to routine diagnostic procedures impacts the psychiatric diagnostic process.
METHOD


We compared the outcome of a diagnostic procedure that included the CFI with routine diagnostic procedures used at Swedish psychiatric clinics. New patients (n = 256) admitted to a psychiatric outpatient clinic were randomized to a control (n = 122) or CFI-enhanced diagnostic procedure (n = 134) group. An intention-to-treat analysis was conducted and the prevalence ratio and corresponding 95% confidence intervals (CI) were calculated across arms for depressive and anxiety disorder diagnoses, multiple diagnoses, and delayed diagnosis.
RESULTS


The prevalence ratio (PR) of a depressive disorder diagnosis across arms was 1.21 (95% CI = 0.83-1.75), 33.6% of intervention-arm participants vs. 27.9% of controls. The prevalence ratio was higher among patients whose native language was not Swedish (PR =1.61, 95% CI = 0.91-2.86). The prevalence ratio of receiving multiple diagnoses was higher for the CFI group among non-native speaking patients, and lower to a statistically significant degree among native Swedish speakers (PR = .39, 95% CI = 0.18-0.82).
CONCLUSIONS


The results suggest that the implementation of the DSM-5 CFI in routine psychiatric diagnostic practice may facilitate identification of symptoms of certain psychiatric disorders, like depression, among non-native speaking patients in a migration context. The CFI did not result in a reduction of patients with a non-definite diagnosis.
TRIAL REGISTRATION


ISRCTN51527289 , 30/07/2019. The trial was retrospectively registered.",2022,"The prevalence ratio was higher among patients whose native language was not Swedish (PR =1.61, 95% CI = 0.91-2.86).","['Sweden', 'New patients (n\u2009=\u2009256) admitted to a psychiatric outpatient clinic']",['CFI-enhanced diagnostic procedure'],"['prevalence ratio', 'prevalence ratio (PR) of a depressive disorder diagnosis', 'prevalence ratio of receiving multiple diagnoses']","[{'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]",256.0,0.0864493,"The prevalence ratio was higher among patients whose native language was not Swedish (PR =1.61, 95% CI = 0.91-2.86).","[{'ForeName': 'Malin Idar', 'Initials': 'MI', 'LastName': 'Wallin', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm, Region Stockholm, Sweden. malin.idar.wallin@ki.se.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Galanti', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, & Centre for Epidemiology and Community Medicine (CES), Stockholm, Region Stockholm, Sweden.'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Nevonen', 'Affiliation': 'Department of Medical Sciences, Faculty of Medicine and Health, Örebro University, & Aleris Psychiatry AB, Stockholm, Sweden.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Lewis-Fernández', 'Affiliation': 'Columbia University and New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Bäärnhielm', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Stockholm, Region Stockholm, Sweden.'}]",BMC psychiatry,['10.1186/s12888-022-03791-9']
2528,35216547,Protocol for a randomized controlled multicenter trial assessing the efficacy of leuprorelin for severe polycystic liver disease: the AGAINST-PLD study.,"BACKGROUND


In patients with severe polycystic liver disease (PLD), there is a need for new treatments. Estrogens and possibly other female sex hormones stimulate growth in PLD. In some patients, liver volume decreases after menopause. Female sex hormones could therefore be a target for therapy. The AGAINST-PLD study will examine the efficacy of the GnRH agonist leuprorelin, which blocks the production of estrogen and other sex hormones, to reduce liver growth in PLD.
METHODS


The AGAINST-PLD study is an investigator-driven, multicenter, randomized controlled trial. Institutional review board (IRB) approval was received at the University Medical Center of Groningen and will be collected in other sites before opening these sites. Thirty-six female, pre-menopausal patients, with a very large liver volume for age (upper 10% of the PLD population) and ongoing liver growth despite current treatment options will be randomized to direct start of leuprorelin or to 18 months standard of care and delayed start of leuprorelin. Leuprorelin is given as 3.75 mg subcutaneously (s.c.) monthly for the first 3 months followed by 3-monthly depots of 11.25 mg s.c. The trial duration is 36 months. MRI scans to measure liver volume will be performed at screening, 6 months, 18 months, 24 months and 36 months. In addition, blood will be drawn, DEXA-scans will be performed and questionnaires will be collected. This design enables comparison between patients on study treatment and standard of care (first 18 months) and within patients before and during treatment (whole trial). Main outcome is annualized liver growth rate compared between standard of care and study treatment. Secondary outcomes are PLD disease severity, change in liver growth within individuals and (serious) adverse events. The study is designed as a prospective open-label study with blinded endpoint assessment (PROBE).
DISCUSSION


In this trial, we combined the expertise of hepatologist, nephrologists and gynecologists to study the effect of leuprorelin on liver growth in PLD. In this way, we hope to stop liver growth, reduce symptoms and reduce the need for liver transplantation in severe PLD. Trial registration Eudra CT number 2020-005949-16, registered at 15 Dec 2020. https://www.clinicaltrialsregister.eu/ctr-search/search?query=2020-005949-16 .",2022,"The AGAINST-PLD study will examine the efficacy of the GnRH agonist leuprorelin, which blocks the production of estrogen and other sex hormones, to reduce liver growth in PLD.
","['patients with severe polycystic liver disease (PLD', 'Thirty-six female, pre-menopausal patients, with a very large liver volume for age (upper 10% of the PLD population) and ongoing liver growth despite current treatment options', 'severe polycystic liver disease', 'Trial registration Eudra CT number 2020-005949-16, registered at 15 Dec 2020']","['leuprorelin', 'Leuprorelin']","['PLD disease severity, change in liver growth within individuals and (serious) adverse events', 'annualized liver growth rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0158683', 'cui_str': 'Congenital cystic disease of liver'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0450093', 'cui_str': 'Very large'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0085272', 'cui_str': 'Leuprolide'}]","[{'cui': 'C0158683', 'cui_str': 'Congenital cystic disease of liver'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}]",,0.0590553,"The AGAINST-PLD study will examine the efficacy of the GnRH agonist leuprorelin, which blocks the production of estrogen and other sex hormones, to reduce liver growth in PLD.
","[{'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Aapkes', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'L H P', 'Initials': 'LHP', 'LastName': 'Bernts', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'van den Berg', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van den Berg', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Blokzijl', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'A E P', 'Initials': 'AEP', 'LastName': 'Cantineau', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'M D A', 'Initials': 'MDA', 'LastName': 'van Gastel', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'de Haas', 'Affiliation': 'Department of Radiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kappert', 'Affiliation': 'Department of Radiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'R U', 'Initials': 'RU', 'LastName': 'Müller', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, Faculty of Medicine, University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nevens', 'Affiliation': 'Department of Gastroenterology and Hepatology, Universiteitsziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Torra', 'Affiliation': 'Department of Nephrology, Fundacio Puigvert, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Visser', 'Affiliation': 'Department of Applied Health Sciences, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'J P H', 'Initials': 'JPH', 'LastName': 'Drenth', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Gansevoort', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. r.t.gansevoort@umcg.nl.'}]",BMC gastroenterology,['10.1186/s12876-022-02142-y']
2529,35221653,Use of tourniquet does not increase serum concentration of inflammatory mark-ers following total knee arthroplasty during the first 24 postoperative hours.,"BACKGROUND


The literature on the systemic inflammatory reaction following tourniquet-induced ischemia and reperfusion in elective orthopedic surgery is limited.
METHODS


This prospective comparative study compared the levels of clinically relevant cytokines and peripheral blood counts and major complications in patients undergoing total knee arthroplasty (TKA) with or without a tourniquet during the first postoperative day. Forty-three patients undergoing primary TKA for degenerative osteoarthritis were divided into two groups; 21 patients were operated on using (TG group) and 22 (NTG group) without using a tourniquet. Proinflammatory cytokines interleukin-1b, interleukin-6, anti-inflammatory cytokine interleukin-10, intercellular and vascular adhesion molecules, C-reactive protein, and full blood count were evaluated preoperatively and at one, three, six, and 24 hours postoperatively in both groups.
RESULTS


Demographics, American Society of Anesthesiologists score, surgery duration, osteoarthritis grade, and other preoperative variable values were comparable between groups. The average tourniquet time was 67.8 minutes. The majority of testing variables did not demonstrate significant postoperative differences between groups. However, the mean IL-6 value was non-significantly higher for the TG than the NTG group during the first six postoperative hours. It demonstrated a trend to significance at the end of the first postoperative day. The mean hemoglobin and hematocrit levels were significantly higher for the NTG group at the sixth postoperative hour.
CONCLUSIONS


The tourniquet use may affect the systemic inflammatory response. Patients undergoing TKA with or without a tourniquet demonstrated a similar systemic inflammatory response. However, reperfusion following approximately 70 minutes of tourniquet ischemia is a safe practice. HIPPOKRATIA 2021, 25 (1):31-37.",2021,"The mean hemoglobin and hematocrit levels were significantly higher for the NTG group at the sixth postoperative hour.
","['patients undergoing total knee arthroplasty (TKA) with or without a tourniquet during the first postoperative day', 'Forty-three patients undergoing primary TKA for degenerative osteoarthritis']","['22 (NTG group) without using a tourniquet', 'NTG']","['mean IL-6 value', 'mean hemoglobin and hematocrit levels', 'systemic inflammatory response', 'Demographics, American Society of Anesthesiologists score, surgery duration, osteoarthritis grade, and other preoperative variable values', 'Proinflammatory cytokines interleukin-1b, interleukin-6, anti-inflammatory cytokine interleukin-10, intercellular and vascular adhesion molecules, C-reactive protein, and full blood count', 'average tourniquet time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0428724', 'cui_str': 'Duration of tourniquet inflation'}]",43.0,0.05745,"The mean hemoglobin and hematocrit levels were significantly higher for the NTG group at the sixth postoperative hour.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mourikis', 'Affiliation': 'Orthopedic Department, Laiko General Hospital, Athens.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kenanidis', 'Affiliation': 'Academic Orthopedic Department, Papageorgiou General Hospital.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Venetsanou', 'Affiliation': 'ICU Research Unit, ""Agioi Anargyroi"" General Hospital, National and Kapodistrian University of Athens.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Tzavellas', 'Affiliation': 'Academic Orthopedic Department, Papageorgiou General Hospital.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Papaioannou', 'Affiliation': ""KAT Accident Hospital, Greece & Laboratory for Research of the Musculoskeletal System, 'Th. Garofalidis', University of Athens, KAT Hospital Athens, Greece.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tsiridis', 'Affiliation': 'Academic Orthopedic Department, Papageorgiou General Hospital.'}]",Hippokratia,[]
2530,35221650,Comparison of serratus plane block alone and in combination with pectoral type 1 block for breast cancer surgery: a randomized controlled study.,"BACKGROUND/AIM


Concurrent application of ultrasound-guided pectoral type 1 (PECS I) and serratus plane block (SPB) is one of the most appropriate multimodal analgesic strategies for reducing acute post-mastectomy pain. The purpose of the present study was to compare the analgesic efficacy of SPB alone, or in combination with PECS I block for post-mastectomy pain following breast cancer surgery.
MATERIALS AND METHODS


Sixty participants undergoing breast cancer surgery were randomly assigned to two groups. After anesthesia induction, group S (n =30) received SPB alone, whereas the SPECS group (n =30) received a combination of PECS I and SPB. Pain scores at 0, 1, 2, 6, 12, 24 h postoperatively, intra-operative fentanyl consumption, postoperative time to first rescue analgesia, nausea, vomiting, patient satisfaction, and anesthesia-related complications were recorded.
RESULTS


Pain scores in the SPECS group were significantly lower than group S throughout the follow-up period (p <0.001). A significant reduction in postoperative rescue morphine consumption (p =0.01, median difference 7 mg, 95 % confidence interval: 5.1-7.9 mg) and intraoperative fentanyl consumption (p =0.01) in the SPECS group compared with group S. Moreover, postoperative nausea and vomiting were lower, and patient satisfaction was higher in the SPECS group compared with that of the group S.
CONCLUSIONS


These results suggest that SPB application and PECS I provide more effective and reliable perioperative analgesia and increase patient satisfaction in breast cancer surgery. HIPPOKRATIA 2021, 25 (1):8-14.
TRIAL REGISTRATION NUMBER


NCT03899545.",2021,"A significant reduction in postoperative rescue morphine consumption (p =0.01, median difference 7 mg, 95 % confidence interval: 5.1-7.9 mg) and intraoperative fentanyl consumption (p =0.01) in the SPECS group compared with group S. Moreover, postoperative nausea and vomiting were lower, and patient satisfaction was higher in the SPECS group compared with that of the group S.
","['breast cancer surgery', 'Sixty participants undergoing breast cancer surgery', 'HIPPOKRATIA 2021, 25']","['SPB alone, or in combination with PECS I block', 'combination of PECS I and SPB', 'SPB alone', 'SPECS', 'ultrasound-guided pectoral type 1 (PECS I) and serratus plane block (SPB', 'serratus plane block alone and in combination with pectoral type 1 block']","['intra-operative fentanyl consumption, postoperative time to first rescue analgesia, nausea, vomiting, patient satisfaction, and anesthesia-related complications', 'Pain scores', 'analgesic efficacy', 'patient satisfaction', 'intraoperative fentanyl consumption', 'postoperative rescue morphine consumption', 'postoperative nausea and vomiting']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0055065', 'cui_str': 'CEP combination'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]",60.0,0.219463,"A significant reduction in postoperative rescue morphine consumption (p =0.01, median difference 7 mg, 95 % confidence interval: 5.1-7.9 mg) and intraoperative fentanyl consumption (p =0.01) in the SPECS group compared with group S. Moreover, postoperative nausea and vomiting were lower, and patient satisfaction was higher in the SPECS group compared with that of the group S.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yesiltas', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Türköz', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Çalım', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Esen', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Daşkaya', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Bezmialem Vakıf University, Istanbul, Turkey.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Karaaslan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Bezmialem Vakıf University, Istanbul, Turkey.'}]",Hippokratia,[]
2531,35221636,Randomised controlled trial of online empathy focused intercultural communication program for Turkish local society to increase their social acceptance towards refugees.,"The current study investigated the effectiveness of an online-based, empathy-focused intervention program that is developed for Turkish local society to increase their positive attitudes towards refugees. The sample of the four-week intervention program consisted of 52 participants that were randomly assigned to experimental ( n  = 26) and control groups ( n  = 26). Participants completed the Attitudes towards Syrians Scale in both groups before and after the intervention program. In the control group, no implementation was provided, only the individuals filled the pre-test and post-test questionnaires within the same periods as the experimental group. Participants in the experimental group also filled a sentence completion activity at the end of the program. The results of the study showed that Empathy Focused Intercultural Communication Program for Turkish Local Society showed a positive promissory approach for increasing positive attitudes towards Syrian refugees, increasing emphatic and altruistic approach. Lastly, these results, limitations, and suggestions for future research were discussed and the possible implications were shared.",2022,"In the control group, no implementation was provided, only the individuals filled the pre-test and post-test questionnaires within the same periods as the experimental group.",[],"['online-based, empathy-focused intervention program', 'online empathy focused intercultural communication program']",['Attitudes towards Syrians Scale'],[],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009457', 'cui_str': 'Communication Programs'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0018561', 'cui_str': 'Mesocricetus auratus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",52.0,0.0121287,"In the control group, no implementation was provided, only the individuals filled the pre-test and post-test questionnaires within the same periods as the experimental group.","[{'ForeName': 'Arzu Çalışkan', 'Initials': 'AÇ', 'LastName': 'Sarı', 'Affiliation': 'Psychology Department, Çankırı Karatekin University, Ankara, Turkey.'}, {'ForeName': 'Özden Yalçınkaya', 'Initials': 'ÖY', 'LastName': 'Alkar', 'Affiliation': 'Ankara Yıldırım Beyazıt University, Ankara, Turkey.'}]","Current psychology (New Brunswick, N.J.)",['10.1007/s12144-022-02848-y']
2532,35221635,Psychotherapeutic intervention on breast self-examination based on Health Belief Model.,"The aim of this research was to verify the effectiveness of a Health Belief Model-based intervention in increasing knowledge and changing beliefs about breast cancer and its early detection as well as in improving breast self-examination behaviors. This randomized controlled clinical trial involved 210 women. The program was implemented by email and involved sending daily messages to participants for 30 days. The women in the intervention group received messages aimed at increasing the practice of breast self-examination behavior. Participants in the control group received messages promoting general health. Before and after the intervention there were evaluated the application of breast self-examination, level of knowledge, beliefs associated with health (susceptibility to develop breast cancer, disease severity, benefits of self-examination, barriers to achieving this behavior, cues to action, self-efficacy in performing self-examination). At the end of the program, a significant improvement in the perception of disease severity and the benefits of breast self-examination was obtained, as well as a significant increase in the percentage of participants who achieved this behavior. The results obtained are arguments for it to be implemented by health care providers who want to promote self-examination as a method of early detection of breast cancer.",2022,"Before and after the intervention there were evaluated the application of breast self-examination, level of knowledge, beliefs associated with health (susceptibility to develop breast cancer, disease severity, benefits of self-examination, barriers to achieving this behavior, cues to action, self-efficacy in performing self-examination).",['210 women'],"['Health Belief Model-based intervention', 'Psychotherapeutic intervention', 'messages promoting general health']","['application of breast self-examination, level of knowledge, beliefs associated with health (susceptibility to develop breast cancer, disease severity, benefits of self-examination, barriers to achieving this behavior, cues to action, self-efficacy', 'perception of disease severity and the benefits of breast self-examination']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}]","[{'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0085105', 'cui_str': 'Breast self-examination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0080142', 'cui_str': 'Self-examination'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",210.0,0.0174536,"Before and after the intervention there were evaluated the application of breast self-examination, level of knowledge, beliefs associated with health (susceptibility to develop breast cancer, disease severity, benefits of self-examination, barriers to achieving this behavior, cues to action, self-efficacy in performing self-examination).","[{'ForeName': 'Adelina Mihaela', 'Initials': 'AM', 'LastName': 'Ştefănuţ', 'Affiliation': 'Department of Psychology, West University of Timișoara, Vasile Pârvan Blvd., 300223 Timișoara, Romania.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Vintilă', 'Affiliation': 'Department of Psychology, West University of Timișoara, Vasile Pârvan Blvd., 300223 Timișoara, Romania.'}]","Current psychology (New Brunswick, N.J.)",['10.1007/s12144-022-02871-z']
2533,35221539,ILM peeling with ILM flap transposition vs. classic ILM peeling for small and medium macula holes-a prospective randomized trial.,"Background


The aim of the present study was to compare macular hole closure rates of patients with small and medium-sized macular holes who underwent vitrectomy with internal limiting membrane (ILM) peeling combined with ILM flap transposition over the macular hole, compared with classic ILM peeling.
Methods


This prospective randomized trial was designed as a pilot study with two groups: ILM peeling with ILM flap transposition over the macular hole vs. classic ILM peeling.
Results


Among 20 patients recruited, complete analysis could be performed for 16 patients. The macular hole closure rates were 100% in both groups, without significant differences with respect to postsurgical subfoveal hyporeflective zones ( p  = 1.0, Fisher's exact test), postsurgical visual acuity ( p  = 0.7,  t -test), and postsurgical irregularities of the ellipsoid zone ( p  = 1.0, Fisher's exact test).
Conclusion


Vitrectomy with ILM peeling combined with ILM flap transposition over the macular hole and classic ILM peeling are both successful methods for the repair of macular holes of small and medium size and are associated with comparable outcomes.",2022,"The macular hole closure rates were 100% in both groups, without significant differences with respect to postsurgical subfoveal hyporeflective zones ( p  = 1.0, Fisher's exact test), postsurgical visual acuity ( p  = 0.7,  t -test), and postsurgical irregularities of the ellipsoid zone ( p  = 1.0, Fisher's exact test).
","['20\xa0patients recruited, complete analysis could be performed for 16\xa0patients', 'patients with small and medium-sized macular holes who underwent']","['ILM peeling with ILM flap transposition over the macular hole vs. classic ILM peeling', 'ILM peeling combined with ILM flap transposition', 'vitrectomy with internal limiting membrane (ILM) peeling combined with ILM flap transposition', 'ILM peeling with ILM flap transposition vs. classic ILM peeling']","['postsurgical irregularities of the ellipsoid zone', 'postsurgical subfoveal hyporeflective zones', 'macular hole closure rates', 'postsurgical visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0040674', 'cui_str': 'Transposition procedure'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}]","[{'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",,0.0822659,"The macular hole closure rates were 100% in both groups, without significant differences with respect to postsurgical subfoveal hyporeflective zones ( p  = 1.0, Fisher's exact test), postsurgical visual acuity ( p  = 0.7,  t -test), and postsurgical irregularities of the ellipsoid zone ( p  = 1.0, Fisher's exact test).
","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Leisser', 'Affiliation': 'VIROS-Vienna Institute for Research in Ocular Surgery, a\xa0Karl Landsteiner Institute, Hanusch Hospital, Heinrich Collin Straße\xa030, 1140 Vienna, Austria.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruiss', 'Affiliation': 'VIROS-Vienna Institute for Research in Ocular Surgery, a\xa0Karl Landsteiner Institute, Hanusch Hospital, Heinrich Collin Straße\xa030, 1140 Vienna, Austria.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Pilwachs', 'Affiliation': 'VIROS-Vienna Institute for Research in Ocular Surgery, a\xa0Karl Landsteiner Institute, Hanusch Hospital, Heinrich Collin Straße\xa030, 1140 Vienna, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Findl', 'Affiliation': 'VIROS-Vienna Institute for Research in Ocular Surgery, a\xa0Karl Landsteiner Institute, Hanusch Hospital, Heinrich Collin Straße\xa030, 1140 Vienna, Austria.'}]","Spektrum der Augenheilkunde : Zeitschrift der Osterreichischen Ophthalmologischen Gesellschaft, OOG",['10.1007/s00717-022-00515-y']
2534,35222018,Impact of Pharmacist-Led Diabetes Self-Care Education on Patients With Type 2 Diabetes in Pakistan: A Randomized Controlled Trial.,"Introduction:  There is a little evidence on efficacy of pharmacy-based interventions on clinical outcomes of type 2 diabetes mellitus (T2DM) patients in Pakistan.  Objective:  To appraise the impact of pharmacist-led self-care education on glycemic control, self-care practices and disease knowledge of T2DM patients with poor glycemic control (HbA1c ≥ 7%).  Methods:  In this 6-months, randomized controlled trial (RCT),  n  = 75, T2DM patients seeking care at a diabetes clinic were randomized in to two groups. Intervention group ( n  = 38) received two face-to-face educational sessions (at enrollment and on week 12), whereas control group ( n  = 37) received usual care. Outcome measures such as glycemic control, self-care practices and disease knowledge were assessed at the time of enrollment and after 6-months in both groups.  Results:  Thirty-three intervention and thirty-three participants from the control group completed the study. Mean glycated hemoglobin (% HbA1c) significantly reduced in the intervention group from 9.00 ± 1.43 to 8.09 ± 1.16 ( p  < .01). However, no significant change was observed in the control group (9.20 ± 1.24 to 8.93 ± .97;  p  = .06). Cohen's d effect size of the intervention on HbA1c was .78. Percentage of participants achieving glycemic control (HbA1c < 7%) were significantly higher ( p  < .05) in the intervention group as compared to the control group (twenty-four vs. six), after 6 months of the trial. A significant ( p  < .01) improvement in mean scores for disease knowledge and self-care activities was also observed in the intervention group participants, whereas no significant improvements ( p  > .05) were observed in the control group.  Conclusion:  The study demonstrated an improvement in glycemic control, disease knowledge and self-care activities of T2DM patients who received pharmacist-led educational intervention. The study findings support clinical significance of integrating pharmacy-based interventions in diabetes management.",2022,"A significant ( p  < .01) improvement in mean scores for disease knowledge and self-care activities was also observed in the intervention group participants, whereas no significant improvements ( p  > .05) were observed in the control group.  ","['Patients With Type 2 Diabetes in Pakistan', 'n  = 75, T2DM patients seeking care at a diabetes clinic', 'T2DM patients with poor glycemic control (HbA1c ≥ 7', 'type 2 diabetes mellitus (T2DM) patients in Pakistan', 'Results:  Thirty-three intervention and thirty-three participants from the control group', 'diabetes management']","['pharmacy-based interventions', 'pharmacist-led educational intervention', 'Pharmacist-Led Diabetes Self-Care Education', 'usual care', 'pharmacist-led self-care education', 'two face-to-face educational sessions']","['Mean glycated hemoglobin', 'glycemic control, disease knowledge and self-care activities', 'glycemic control, self-care practices and disease knowledge', 'mean scores for disease knowledge and self-care activities', 'glycemic control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0567459', 'cui_str': 'Self-care practice'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",75.0,0.010027,"A significant ( p  < .01) improvement in mean scores for disease knowledge and self-care activities was also observed in the intervention group participants, whereas no significant improvements ( p  > .05) were observed in the control group.  ","[{'ForeName': 'Allah', 'Initials': 'A', 'LastName': 'Bukhsh', 'Affiliation': 'School of Pharmacy, Monash University, Jalan Lagoon Selatan, Malaysia.'}, {'ForeName': 'Tahir Mehmood', 'Initials': 'TM', 'LastName': 'Khan', 'Affiliation': 'School of Pharmacy, Monash University, Jalan Lagoon Selatan, Malaysia.'}, {'ForeName': 'Pochamana', 'Initials': 'P', 'LastName': 'Phisalprapa', 'Affiliation': 'Division of Ambulatory Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Acharaporn', 'Initials': 'A', 'LastName': 'Duangjai', 'Affiliation': 'Division of Ambulatory Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Surasak', 'Initials': 'S', 'LastName': 'Saokaew', 'Affiliation': 'Unit of Excellence in Research and Product Development of Coffee, Division of Physiology, School of Medical Sciences, University of Phayao, Phayao, Thailand.'}, {'ForeName': 'Muhammad Sarfraz', 'Initials': 'MS', 'LastName': 'Nawaz', 'Affiliation': 'Department of Pharmacy, Quaid-i-Azam University Islamabad, Islamabad, Pakistan.'}, {'ForeName': 'Hafiz Sajjad', 'Initials': 'HS', 'LastName': 'Ahmed', 'Affiliation': 'Capital Hospital, Islamabad, Pakistan.'}, {'ForeName': 'Bey-Hing', 'Initials': 'BH', 'LastName': 'Goh', 'Affiliation': 'School of Pharmacy, Monash University, Jalan Lagoon Selatan, Malaysia.'}]",Frontiers in pharmacology,['10.3389/fphar.2022.754999']
2535,35221936,Individual Sensory Modality Dominance as an Influential Factor in the Prefrontal Neurofeedback Training for Spatial Processing: A Functional Near-Infrared Spectroscopy Study.,"Neurofeedback is a neuromodulation technique used to improve brain function by self-regulating brain activity. However, the efficacy of neurofeedback training varies widely between individuals, and some participants fail to self-regulate brain activity. To overcome intersubject variation in neurofeedback training efficacy, it is critical to identify the factors that influence this type of neuromodulation. In this study, we considered that individual differences in cognitive ability may influence neurofeedback training efficacy and aimed to clarify the effect of individual working memory (WM) abilities, as characterized by sensory modality dominance, on neurofeedback training efficacy in healthy young adults. In particular, we focused on the abilities of individuals to retain internal (tactile or somatosensory) or external (visual) body information in their WM. Forty participants performed functional near-infrared spectroscopy-based neurofeedback training aimed at producing efficient and lower-level activity in the bilateral dorsolateral prefrontal cortex and frontopolar cortex. We carried out a randomized, sham-controlled, double-blind study that compared WM ability before and after neurofeedback training. Individual WM ability was quantified using a target searching task that required the participants to retain spatial information presented as vibrotactile or visual stimuli. Participants who received feedback information based on their own prefrontal activity showed gradually decreasing activity in the right prefrontal area during the neurofeedback training and demonstrated superior WM ability during the target searching task with vibrotactile stimuli compared with the participants who performed dummy neurofeedback training. In comparison, left prefrontal activity was not influenced by the neurofeedback training. Furthermore, the efficacy of neurofeedback training (i.e., lower right prefrontal activity and better searching task performance) was higher in participants who exhibited tactile dominance rather than visual dominance in their WM. These findings indicate that sensory modality dominance in WM may be an influential neurophysiological factor in determining the efficacy of neurofeedback training. These results may be useful in the development of neurofeedback training protocols tailored to individual needs.",2022,"Furthermore, the efficacy of neurofeedback training (i.e., lower right prefrontal activity and better searching task performance) was higher in participants who exhibited tactile dominance rather than visual dominance in their WM.","['Forty participants performed', 'participants who exhibited tactile dominance rather than visual dominance in their WM', 'healthy young adults']","['individual working memory (WM) abilities', 'neurofeedback training', 'retain internal (tactile or somatosensory) or external (visual) body information in their WM', 'functional near-infrared spectroscopy-based neurofeedback training']","['right prefrontal activity and better searching task performance', 'left prefrontal activity', 'Individual WM ability']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",40.0,0.018793,"Furthermore, the efficacy of neurofeedback training (i.e., lower right prefrontal activity and better searching task performance) was higher in participants who exhibited tactile dominance rather than visual dominance in their WM.","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sakurada', 'Affiliation': 'Department of Robotics, College of Science and Engineering, Ritsumeikan University, Shiga, Japan.'}, {'ForeName': 'Mayuko', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Functional Brain Science Laboratory, Center for Development of Advanced Medical Technology, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Shin-Ichiroh', 'Initials': 'SI', 'LastName': 'Yamamoto', 'Affiliation': 'Graduate School of Systems Engineering and Science, Shibaura Institute of Technology, Saitama, Japan.'}]",Frontiers in systems neuroscience,['10.3389/fnsys.2022.774475']
2536,35221930,Using Hebbian-Type Stimulation to Rescue Arm Function After Stroke: Study Protocol for a Randomized Clinical Trial.,"Background


Upper-extremity hemiplegia after stroke remains a significant clinical problem. The supplementary motor area (SMA) is vital to the motor recovery outcomes of chronic stroke patients. Therefore, rebuilding the descending motor tract from the SMA to the paralyzed limb is a potential approach to restoring arm motor function after stroke. Paired associative stimulation (PAS), which is based on Hebbian theory, is a potential method for reconstructing the connections in the impaired motor neural circuits. The study described in this protocol aims to assess the effects of cortico-peripheral Hebbian-type stimulation (HTS), involving PAS, for neural circuit reconstruction to rescue the paralyzed arm after stroke.
Methods


The study is a 4-month double-blind randomized sham-controlled clinical trial. We will recruit 90 post-stroke individuals with mild to moderate upper limb paralysis. Based on a 1:1 ratio, the participants will be randomly assigned to the HTS and sham groups. Each participant will undergo 5-week HTS or sham stimulation. Assessments will be conducted at baseline, immediately after the 5-week treatment, and at a 3-month follow-up. The primary outcome will be the Wolf Motor Function Test (WMFT). The secondary outcomes will be Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Functional Independence Measure (FIM), and functional near-infrared spectroscopy (fNIRS) parameters. The adverse events will be recorded throughout the study.
Discussion


Upper-limb paralysis in stroke patients is due to neural circuit disruption, so the reconstruction of effective motor circuits is a promising treatment approach. Based on its anatomical structure and function, the SMA is thought to compensate for motor dysfunction after focal brain injury at the cortical level. Our well-designed randomized controlled trial will allow us to analyze the clinical efficacy of this novel Hebbian theory-based neuromodulation strategy regarding promoting the connection between the cortex and peripheral limb. The results may have significance for the development and implementation of effective neurorehabilitation treatments.
Clinical Trial Registration


[www.ClinicalTrials.gov], identifier [ChiCTR2000039949].",2021,"The secondary outcomes will be Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Functional Independence Measure (FIM), and functional near-infrared spectroscopy (fNIRS) parameters.","['stroke patients', '90 post-stroke individuals with mild to moderate upper limb paralysis', 'chronic stroke patients']","['Hebbian-Type Stimulation to Rescue Arm Function', 'Paired associative stimulation (PAS', 'cortico-peripheral Hebbian-type stimulation (HTS), involving PAS']","['Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Functional Independence Measure (FIM), and functional near-infrared spectroscopy (fNIRS) parameters', 'adverse events', 'Wolf Motor Function Test (WMFT']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0237766', 'cui_str': 'Hysterical paralysis'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.311762,"The secondary outcomes will be Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Functional Independence Measure (FIM), and functional near-infrared spectroscopy (fNIRS) parameters.","[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Shanghai Zhaxin Traditional Chinese and Western Medicine Hospital, Shanghai, China.'}, {'ForeName': 'Guang-Yue', 'Initials': 'GY', 'LastName': 'Zhu', 'Affiliation': 'Tongji Hospital Affiliated to Tongji University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Zhaxin Traditional Chinese and Western Medicine Hospital, Shanghai, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Shanghai Yangzhi Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Xiang-Xin', 'Initials': 'XX', 'LastName': 'Xing', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lin-Yu', 'Initials': 'LY', 'LastName': 'Chen', 'Affiliation': 'Shanghai Yangzhi Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Shanghai Yangzhi Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Fu-Qiang', 'Initials': 'FQ', 'LastName': 'Shen', 'Affiliation': 'Shanghai Yangzhi Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Jian-Bing', 'Initials': 'JB', 'LastName': 'Chen', 'Affiliation': 'Shanghai Yangzhi Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Xu-Yun', 'Initials': 'XY', 'LastName': 'Hua', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Dong-Sheng', 'Initials': 'DS', 'LastName': 'Xu', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}]",Frontiers in neural circuits,['10.3389/fncir.2021.789095']
2537,35221894,Effect of Transcranial Direct Current Stimulation on the Mismatch Negativity Features of Deviated Stimuli in Children With Autism Spectrum Disorder.,"Autism spectrum disorder (ASD) is a devastating mental disorder in children. Currently, there is no effective treatment for ASD. Transcranial direct current stimulation (tDCS), which is a non-invasive brain stimulation neuromodulation technology, is a promising method for the treatment of ASD. However, the manner in which tDCS changes the electrophysiological process in the brain is still unclear. In this study, we used tDCS to stimulate the dorsolateral prefrontal cortex area of children with ASD (one group received anode tDCS, and the other received sham tDCS) and investigated the changes in evoked EEG signals and behavioral abilities before and after anode and sham stimulations. In addition to tDCS, all patients received conventional rehabilitation treatment. Results show that although conventional treatment can effectively improve the behavioral ability of children with ASD, the use of anode tDCS with conventional rehabilitation can boost this improvement, thus leading to increased treatment efficacy. By analyzing the electroencephalography pre- and post-treatment, we noticed a decrease in the mismatch negativity (MMN) latency and an increase in the MMN amplitude in both groups, these features are considered similar to MMN features from healthy children. However, no statistical difference between the two groups was observed after 4 weeks of treatment. In addition, the MMN features correlate well with the aberrant behavior checklist (ABC) scale, particularly the amplitude of MMN, thus suggesting the feasibility of using MMN features to assess the behavioral ability of children with ASD.",2022,"However, no statistical difference between the two groups was observed after 4 weeks of treatment.","['children with ASD (one group received', 'Children With Autism Spectrum Disorder', 'children with ASD', 'Autism spectrum disorder (ASD']","['Transcranial Direct Current Stimulation', 'tDCS', 'Transcranial direct current stimulation (tDCS', 'anode tDCS, and the other received sham tDCS', 'conventional rehabilitation treatment']","['aberrant behavior checklist (ABC) scale', 'behavioral ability', 'MMN amplitude', 'evoked EEG signals and behavioral abilities', 'mismatch negativity (MMN) latency']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0003103', 'cui_str': 'Anode'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0393847', 'cui_str': 'Motor neuropathy with multiple conduction block'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",,0.0328473,"However, no statistical difference between the two groups was observed after 4 weeks of treatment.","[{'ForeName': 'Changcheng', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Academy of Medical Engineering and Translational Medicine, Tianjin University, Tianjin, China.'}, {'ForeName': 'Zhuoyue', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Department of Rehabilitation Medical, Tianjin Union Medical Centre, Tianjin, China.'}, {'ForeName': 'Longlong', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'China Electronics Cloud Brain (Tianjin) Technology Co., Ltd., Tianjin, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Tian', 'Affiliation': 'Department of Rehabilitation Medical, Tianjin Union Medical Centre, Tianjin, China.'}, {'ForeName': 'Wenchang', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Rehabilitation Medical, Tianjin Union Medical Centre, Tianjin, China.'}, {'ForeName': 'Jingang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Department of Rehabilitation Medical, Tianjin Union Medical Centre, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medical, Tianjin Union Medical Centre, Tianjin, China.'}, {'ForeName': 'Chunfang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medical, Tianjin Union Medical Centre, Tianjin, China.'}]",Frontiers in neuroscience,['10.3389/fnins.2022.721987']
2538,35222267,Uterine Cavity Irrigation With Office Hysteroscopy During Ovarian Stimulation for IVF: A Randomized Controlled Trial.,"Objective


This was a non-blinded randomized controlled study to evaluate whether endometrial irrigation  via  office hysteroscopy during the early follicular phase would lead to a higher level of live birth rates compared to no irrigation in the fresh embryo transfer cycle.
Method


The study was conducted in Tehran university of medical sciences from June 2015 to June 2016. women under the age of 40 with primary infertility without history of previous IVF/ICSI or hysteroscopic examination, were included. Controlled ovarian hyperstimulation was done. Hysteroscopy was performed in the early mid-follicular phase of a stimulation cycle (day 5-7) with a vaginoscopy approach and saline irrigation in hysteroscopy group. Embryo-transfer was done in the same cycle.
Results


228 patients completed their participation in the study. In the fresh cycle, clinical pregnancy rate was 46% in the hysteroscopy group and 40.43% in the control group. ( p-value= 0.326, RR= 1.16 [95%CI: 0.862 to 1.56] ). Live birth rate was 41.28% in the hysteroscopic group and 31.93% in the control group ( p-value=0.143, RR= 1.293 [95%CI: 0.916 to 1.825] ). For those patients having surplus cryopreserved embryos, after 2 months, a second embryo transfer was performed. The cumulative LBR was 44.05% in the hysteroscopic group and 32.25% in the control group ( p-value=0.029, RR= 1.368 [95%CI: 1.031 to 1.815], RD= 11.9% [95%CI: 1.2% to 22.3%] and NNT= 8 [95%CI: 4 to 85] ).
Conclusion


The current study clearly demonstrated a significantly higher cumulative live birth rate in the intervention group.
Clinical Trial Registration


[https://www.irct.ir/trial/19586], identifier IRCT2016011022795N2.",2022,"The cumulative LBR was 44.05% in the hysteroscopic group and 32.25% in the control group ( p-value=0.029, RR= 1.368","['228 patients completed their participation in the study', 'Tehran university of medical sciences from June 2015 to June 2016', 'women under the age of 40 with primary infertility without history of previous IVF/ICSI or hysteroscopic examination, were included']","['Uterine Cavity Irrigation With Office Hysteroscopy', 'vaginoscopy approach and saline irrigation', 'endometrial irrigation  via  office hysteroscopy']","['higher level of live birth rates', 'clinical pregnancy rate', 'cumulative live birth rate', 'cumulative LBR', 'Live birth rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0553573', 'cui_str': 'Primary infertility'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0227844', 'cui_str': 'Endometrial cavity structure'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C1271437', 'cui_str': 'Endoscopy of vagina'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0023617', 'cui_str': 'Liberia'}]",,0.368707,"The cumulative LBR was 44.05% in the hysteroscopic group and 32.25% in the control group ( p-value=0.029, RR= 1.368","[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Ghasemi', 'Affiliation': 'Pregnancy Health Research Center, Department of Obstetrics and Gynecology, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Aleyasin', 'Affiliation': 'Department of Infertility, Faculty of Medicine, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Human M', 'Initials': 'HM', 'LastName': 'Fatemi', 'Affiliation': 'In-Vitro-Fertilisation (IVF) Department, Assisted Reproductive Technology (ART) Fertility Clinics, Abu Dhabi, United Arab Emirates, Clinical Laboratory, Assisted Reproductive Technology (ART) Fertility Clinics, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Faezeh', 'Initials': 'F', 'LastName': 'Ghaemdoust', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Shahrakipour', 'Affiliation': 'Department of Biostatistics, Zahedan University of Medical Sciences, Zahedan, Iran.'}]",Frontiers in endocrinology,['10.3389/fendo.2022.778988']
2539,35222266,Association of the Serum Folate and Total Calcium and Magnesium Levels Before Ovarian Stimulation With Outcomes of Fresh  In Vitro  Fertilization Cycles in Normogonadotropic Women.,"Background


Women of reproductive age are recommended to consume folic acid and other supplements before conception and during pregnancy. We aimed to investigate the association of the serum folate and total magnesium (Mg) and calcium (Ca) levels before ovarian stimulation with the outcomes of assisted reproductive technology (ART) in normogonadotropic women.
Methods


We used a subanalysis of data obtained from a multicentre, randomized prospective study (NCT03088137). A total of 110 normogonadotropic, non-advanced aged, non-obese women with tubal and/or male infertility factors were enrolled for the single fresh ovarian stimulation GnRH antagonist cycle. The main outcome measures were the total oocyte yield, mature oocytes, fertilization rate, biochemical, clinical pregnancy, and live birth. Multivariable generalized linear models adjusted for covariates were used with a Poisson distribution and the log link function for adjusted oocyte counts, and a binomial distribution and the log link function were used for adjusted clinical ART outcomes.
Results


The medians (interquartile range (IQR)) were as follows: baseline serum folate, 20.55 ng/ml (10.8, 32.9); Mg, 19.4 mg/L (18.7, 20.7); Ca, 94 mg/L (91.2, 96.4); and Ca/Mg ratio, 4.78 (4.55, 5.02). Women with higher serum folate concentrations (Q4≥33.0 ng/ml) had significantly lower total numbers of oocytes retrieved (adjusted mean (95% CI) 9.2 (7.6-11.3) vs 12.9 (10.9-15.4, p-trend=0.006)) and lower odds ratios (ORs) (95% CI) of 0.12 (0.02, 0.79) for clinical pregnancy and 0.10 (0.01, 0.70) for live birth compared with women in the lowest quartile (<10.8 ng/ml), all p-trend<0.001. Women in the highest Ca/Mg ratio quartile (≥5.02) had ORs (95% CI) of 6.58 (1.31, 33.04) for biochemical pregnancy, 4.85 (1.02, 23.08) for clinical pregnancy and 4.07 (0.83, 19.9) for the live birth rate compared with women in the lowest quartile (<4.55), all p-trend<0.001.
Conclusions


Using multivariable models, we suggested that a baseline elevated serum folate level (≥33.0 ng/ml) and a lower Ca/Mg ratio were associated with worse ART outcomes in normogonadotropic women. Our findings might be useful for choosing safe dosages of folate, calcium, magnesium and complex supplementation for both fertile women and women undergoing infertility treatment. Further preconception large-scale studies with known micro- and macronutrient statuses of both parents and serum folate, Ca, Mg, and hormone levels, are needed.",2022,"Women with higher serum folate concentrations (Q4≥33.0 ng/ml) had significantly lower total numbers of oocytes retrieved (adjusted mean (95% CI) 9.2 (7.6-11.3) vs 12.9 (10.9-15.4, p-trend=0.006)) and lower odds ratios (ORs) (95% CI) of 0.12 (0.02, 0.79) for clinical pregnancy and 0.10 (0.01, 0.70) for live birth compared with women in the lowest quartile (<10.8 ng/ml), all p-trend<0.001.","['\n\n\nWomen of reproductive age', 'A total of 110 normogonadotropic, non-advanced aged, non-obese women with tubal and/or male infertility factors', 'fertile women and women undergoing infertility treatment', 'normogonadotropic women', 'Normogonadotropic Women']","['Fresh', 'folate, calcium, magnesium and complex supplementation', 'folic acid', 'assisted reproductive technology (ART']","['total numbers of oocytes', 'live birth', 'serum folate level', 'Serum Folate and Total Calcium and Magnesium Levels', 'serum folate concentrations', 'total oocyte yield, mature oocytes, fertilization rate, biochemical, clinical pregnancy, and live birth', 'live birth rate', 'serum folate and total magnesium (Mg) and calcium (Ca) levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021364', 'cui_str': 'Male infertility'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0200070', 'cui_str': 'Infertility therapy'}]","[{'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0872104', 'cui_str': 'Assisted reproductive technology'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0202020', 'cui_str': 'Folic acid measurement, serum'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0360641', 'cui_str': 'Calcium- and magnesium-containing product'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}]",,0.40643,"Women with higher serum folate concentrations (Q4≥33.0 ng/ml) had significantly lower total numbers of oocytes retrieved (adjusted mean (95% CI) 9.2 (7.6-11.3) vs 12.9 (10.9-15.4, p-trend=0.006)) and lower odds ratios (ORs) (95% CI) of 0.12 (0.02, 0.79) for clinical pregnancy and 0.10 (0.01, 0.70) for live birth compared with women in the lowest quartile (<10.8 ng/ml), all p-trend<0.001.","[{'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Polzikov', 'Affiliation': 'IVFarma LLC, Moscow, Russia.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Blinov', 'Affiliation': 'Institute for Preventive and Social Medicine, Moscow, Russia.'}, {'ForeName': 'Zarema', 'Initials': 'Z', 'LastName': 'Barakhoeva', 'Affiliation': 'In Vitro Fertilization (IVF) Department, ""AltraVita"" Human Reproduction Clinic, Moscow, Russia.'}, {'ForeName': 'Lyudmila', 'Initials': 'L', 'LastName': 'Vovk', 'Affiliation': 'Perinatal Medical Center, MD Medical Group, Moscow, Russia.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Fetisova', 'Affiliation': 'Perinatal Medical Center, MD Medical Group, Moscow, Russia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ovchinnikova', 'Affiliation': 'Lapino Clinical Hospital, MD Medical Group, Moscow, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Tischenko', 'Affiliation': 'Lapino Clinical Hospital, MD Medical Group, Moscow, Russia.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Zorina', 'Affiliation': 'In Vitro Fertilization (IVF) Department, ""NovaClinic"" Center of Reproductive Medicine and Genetics, Moscow, Russia.'}, {'ForeName': 'Vasily', 'Initials': 'V', 'LastName': 'Yurasov', 'Affiliation': 'Laboratory of Chromatographic Systems LLC, Moscow, Russia.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Ushakova', 'Affiliation': 'IVFarma LLC, Moscow, Russia.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Sergeyev', 'Affiliation': 'Belozersky Institute of Physico-Chemical Biology, Lomonosov Moscow State University, Moscow, Russia.'}]",Frontiers in endocrinology,['10.3389/fendo.2022.732731']
2540,35222248,Patient-Reported Anxiety/Depression After Endovascular Thrombectomy: A  post-hoc  Analysis of Direct-MT Trial.,"Objective


To analyze the effect of endovascular thrombectomy (EVT) alone vs. EVT after an intravenous (IV) alteplase of ischemic stroke on a patient-reported anxiety/depression, and to identify predictors of patient-reported anxiety/depression by analyzing data from Direct Intraarterial Thrombectomy in Order to Revascularize the patients with Acute Ischemic Stroke with a Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals: a Multicenter Randomized Clinical Trial (DIRECT-MT).
Methods


Patients with acute ischemic stroke (AIS), triggered by a large-vessel occlusion in the anterior circulation, were randomly allocated to undergo an EVT after IV alteplase (combination-therapy group) or an EVT alone (EVT-alone group) at a 1:1 ratio in DIRECT-MT. Patients in both groups were followed up for 90 days (±14 days) after stroke using a structured modified Ranking Scale (mRS), a Barthel Index (BI), and a 5-Dimensional European Quality of Life Scale (EQ-5D-5L). Patients who returned EQ-5D-5L were included. The EQ-5D-5L anxiety/depression dimension was used to analyze the patient-reported anxiety/depression. First, differences in patient-reported anxiety/depression were compared between the combination-therapy group and the EVT-alone group. Then, the baseline and influencing factors between the anxiety/depression group and no anxiety/depression group were analyzed using univariate regression analysis. Finally, variables with  p  < 0.1 in univariate regression were subjected to multivariable binary regression analysis to screen independent predictors for patient-reported anxiety /depression after ischemic stroke.
Results


:  Five hundred fifteen patients returned the EQ-5D-5L in Direct-MT. Of these patients, 226 (43.88%) reported a level of anxiety/depression, and about 7% reported a severe or extremely severe anxiety/depression. The patient-reported anxiety/depression in the EVT-alone group was significantly higher than that in the combination-therapy group (48.26% vs. 39.45%,  p  = 0.04). The clinical outcomes were significantly different between the no Anxiety/Depression Group and the anxiety/depression group (mRS at 90 days:2  vs  3,  p  < 0.001; BI of 95 or 100 at 90 days: 73.36% vs 42.04%,  p  < 0.001; EQ-5D-5l utility indexes at 90 days:0.96 vs.57,  p  < 0.001). Logistic regression analysis showed that allocation to thrombolysis before EVT strategy was inversely associated with anxiety/depression [0.61(0.40, 0.94),  p  = 0.03], an insular cortex ischemia, and National Institute of Health Strocke Scale (NIHSS) at 7 days were positively associated with anxiety/depression [2.04(1.07, 3.90),  p  = 0.03; 1.07(1.03, 1.12),  p  < 0.001].
Conclusions


Patient-reported anxiety/depression may suggest that there is a benefit to administering intravenous alteplase before EVT. It may also indicate that it is better to provide IV alteplase before EVT, rather than EVT alone according to patient-reported anxiety/depression. Future research should consider not only the motor function impairments but also the patient-reported mental problems as measures of treatment efficacy in patients with stroke (DIRECT-MT ClinicalTrials.gov number, NCT03469206).",2022,"The clinical outcomes were significantly different between the no Anxiety/Depression Group and the anxiety/depression group (mRS at 90 days:2  vs  3,  p  < 0.001; BI of 95 or 100 at 90 days: 73.36% vs 42.04%,  p  < 0.001; EQ-5D-5l utility indexes at 90 days:0.96 vs.57,  p  < 0.001).","['Patients with acute ischemic stroke (AIS), triggered by a large-vessel occlusion in the anterior circulation', 'Five hundred fifteen patients returned the EQ-5D-5L in Direct-MT', 'Patients who returned EQ-5D-5L were included', 'patients with Acute Ischemic Stroke with a Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals']","['Endovascular Thrombectomy', 'endovascular thrombectomy (EVT) alone vs. EVT', 'EVT after IV alteplase (combination-therapy group) or an EVT alone (EVT-alone group) at a 1:1 ratio in DIRECT-MT']","['level of anxiety/depression', 'Anxiety/Depression', 'anxiety/depression', 'severe or extremely severe anxiety/depression', '5-Dimensional European Quality of Life Scale (EQ-5D-5L', 'EQ-5D-5L anxiety/depression dimension', 'insular cortex ischemia, and National Institute of Health Strocke Scale (NIHSS', 'EQ-5D-5l utility indexes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic)'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0784209,"The clinical outcomes were significantly different between the no Anxiety/Depression Group and the anxiety/depression group (mRS at 90 days:2  vs  3,  p  < 0.001; BI of 95 or 100 at 90 days: 73.36% vs 42.04%,  p  < 0.001; EQ-5D-5l utility indexes at 90 days:0.96 vs.57,  p  < 0.001).","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Hong-Jian', 'Initials': 'HJ', 'LastName': 'Shen', 'Affiliation': 'Department of Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Min-Min', 'Initials': 'MM', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Peng-Fei', 'Initials': 'PF', 'LastName': 'Yang', 'Affiliation': 'Department of Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Peng-Fei', 'Initials': 'PF', 'LastName': 'Xing', 'Affiliation': 'Department of Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Ye', 'Affiliation': 'Department of Statistics, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Lou', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Cong-Guo', 'Initials': 'CG', 'LastName': 'Yin', 'Affiliation': ""Department of Neurology, Hangzhou First People's Hospital, Hangzhou, China.""}, {'ForeName': 'Ben-Qiang', 'Initials': 'BQ', 'LastName': 'Deng', 'Affiliation': 'Department of Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Department of Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Yong-Wei', 'Initials': 'YW', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Jian-Min', 'Initials': 'JM', 'LastName': 'Liu', 'Affiliation': 'Department of Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.'}]",Frontiers in neurology,['10.3389/fneur.2022.811629']
2541,35222225,The Effects of Safinamide Adjunct Therapy on Depression and Apathy in Patients With Parkinson's Disease:  Post-hoc  Analysis of a Japanese Phase 2/3 Study.,"Background and Purpose


Neuropsychiatric symptoms in Parkinson's disease (PD) have been shown to significantly affect quality of life (QOL). We investigated the impact of safinamide on depression and apathy when administered as an adjunct to levodopa in Japanese patients with PD.
Methods


This was a  post-hoc  analysis of data from a phase 2/3 clinical study of safinamide in Japanese patients with PD experiencing wearing-off (JapicCTI-153056; https://www.clinicaltrials.jp/cti-user/trial/ShowDirect.jsp?japicId=JapicCTI-153056). Patients received placebo, safinamide 50 mg, or safinamide 100 mg as an adjunct therapy. The endpoints for this analysis were changes from baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I item 3 (depression) and item 4 (apathy) scores and the Parkinson's Disease Questionnaire (PDQ-39) ""emotional well-being"" domain score. Subgroup analyses investigated the relationship between neuropsychologic symptoms and improvements in motor fluctuation and assessed which patient populations might be expected to obtain neuropsychologic benefit from safinamide.
Results


Compared with placebo, safinamide (both doses) significantly improved UPDRS Part I item 3 scores in the overall analysis population, and the 100-mg dose improved UPDRS Part I item 4 scores in the population with apathy at baseline. Changes in the PDQ-39 ""emotional well-being"" score showed numerical, but not significant, dose-related improvements. Notable reductions in depression were associated with a change in daily ON-time ≥1 h, pain during OFF-time at baseline, and female sex.
Conclusions


The results from this  post-hoc  analysis of the Japanese phase 2/3 study suggest that safinamide could bring benefits to patients with PD who have mild depression, pain during the OFF phase. In addition, safinamide might provide particular benefits for patients with PD who have mild apathy and female.",2021,"Compared with placebo, safinamide (both doses) significantly improved UPDRS","['Japanese patients with PD experiencing wearing-off (JapicCTI-153056; https://www.clinicaltrials.jp/cti-user/trial/ShowDirect.jsp?japicId=JapicCTI-153056', ""Parkinson's disease (PD"", 'patients with PD who have mild apathy and female', 'Japanese patients with PD', ""Patients With Parkinson's Disease""]","['levodopa', 'placebo, safinamide', 'Safinamide Adjunct Therapy', 'UPDRS', 'placebo, safinamide 50 mg, or safinamide 100 mg as an adjunct therapy', 'safinamide']","[""Unified Parkinson's Disease Rating Scale (UPDRS"", 'motor fluctuation', 'PDQ-39 ""emotional', 'UPDRS', 'Depression and Apathy', 'I item 3 (depression) and item 4 (apathy) scores and the Parkinson\'s Disease Questionnaire (PDQ-39) ""emotional well-being"" domain score', 'quality of life (QOL']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1098261', 'cui_str': 'safinamide'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C4475891', 'cui_str': 'safinamide 50 MG'}, {'cui': 'C4475900', 'cui_str': 'safinamide 100 MG'}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C1868976', 'cui_str': 'Motor fluctuations'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.27719,"Compared with placebo, safinamide (both doses) significantly improved UPDRS","[{'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kogo', 'Affiliation': 'Medical Headquarters, Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Michinori', 'Initials': 'M', 'LastName': 'Koebis', 'Affiliation': 'Medical Headquarters, Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ishida', 'Affiliation': 'Medical Headquarters, Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Ippei', 'Initials': 'I', 'LastName': 'Suzuki', 'Affiliation': 'Medicine Development Center, Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology, Saiseikai Imabari Center for Health and Welfare, Ehime, Japan.'}]",Frontiers in neurology,['10.3389/fneur.2021.752632']
2542,35215285,"Apremilast Improves Endothelial Glycocalyx Integrity, Vascular and Left Ventricular Myocardial Function in Psoriasis.","The phosphodiesterase 4 inhibitor apremilast is used for the treatment of psoriasis. We investigated the effects of apremilast on endothelial glycocalyx, vascular and left ventricular (LV) myocardial function in psoriasis. One hundred and fifty psoriatic patients were randomized to apremilast ( n  = 50), anti-tumor necrosis factor-α (etanercept;  n  = 50), or cyclosporine ( n  = 50). At baseline and 4 months post-treatment, we measured: (1) Perfused boundary region (PBR), a marker of glycocalyx integrity, in sublingual microvessels with diameter 5-25 μm using a Sidestream Dark Field camera (GlycoCheck). Increased PBR indicates damaged glycocalyx. Functional microvascular density, an index of microvascular perfusion, was also measured. (2) Pulse wave velocity (PWV-Complior) and (3) LV global longitudinal strain (GLS) using speckle-tracking echocardiography. Compared with baseline, PBR 5-25 μm  decreased only after apremilast (-12% at 4 months,  p  < 0.05) whereas no significant changes in PBR 5-25 μm  were observed after etanercept or cyclosporine treatment. Compared with etanercept and cyclosporine, apremilast resulted in a greater increase of functional microvascular density (+14% versus +1% versus -1%) and in a higher reduction of PWV. Apremilast showed a greater increase of GLS (+13.5% versus +7% versus +2%) than etanercept and cyclosporine ( p  < 0.05). In conclusion, apremilast restores glycocalyx integrity and confers a greater improvement of vascular and myocardial function compared with etanercept or cyclosporine after 4 months.",2022,Apremilast showed a greater increase of GLS (+13.5% versus +7% versus +2%) than etanercept and cyclosporine ( p  < 0.05).,"['Psoriasis', 'psoriasis', 'One hundred and fifty psoriatic patients']","['anti-tumor necrosis factor-α (etanercept;  n  = 50), or cyclosporine', 'etanercept or cyclosporine', 'cyclosporine', 'etanercept and cyclosporine']","['endothelial glycocalyx, vascular and left ventricular (LV) myocardial function', 'GLS', 'PBR', 'PWV', 'Functional microvascular density, an index of microvascular perfusion', 'functional microvascular density', 'Endothelial Glycocalyx Integrity, Vascular and Left Ventricular Myocardial Function', 'measured: (1) Perfused boundary region (PBR), a marker of glycocalyx integrity, in sublingual microvessels with diameter 5-25 μm using a Sidestream Dark Field camera (GlycoCheck', '2) Pulse wave velocity (PWV-Complior) and (3) LV global longitudinal strain (GLS', 'vascular and myocardial function']","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0017767', 'cui_str': 'Glucosinolate'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C2350570', 'cui_str': 'Microvessels'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]",150.0,0.0288033,Apremilast showed a greater increase of GLS (+13.5% versus +7% versus +2%) than etanercept and cyclosporine ( p  < 0.05).,"[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': '2nd Department of Cardiology, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, 12462 Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Pavlidis', 'Affiliation': '2nd Department of Cardiology, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, 12462 Athens, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Kadoglou', 'Affiliation': 'Medical School, University of Cyprus, 2029 Nicosia, Cyprus.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Makavos', 'Affiliation': '2nd Department of Cardiology, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, 12462 Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Katogiannis', 'Affiliation': '2nd Department of Cardiology, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, 12462 Athens, Greece.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Kountouri', 'Affiliation': '2nd Department of Internal Medicine, Research Unit and Diabetes Center, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, 12462 Athens, Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thymis', 'Affiliation': '2nd Department of Cardiology, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, 12462 Athens, Greece.'}, {'ForeName': 'Gavriella', 'Initials': 'G', 'LastName': 'Kostelli', 'Affiliation': '2nd Department of Cardiology, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, 12462 Athens, Greece.'}, {'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Kapniari', 'Affiliation': '2nd Department of Dermatology and Venereology, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, 12462 Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Theodoropoulos', 'Affiliation': '2nd Department of Dermatology and Venereology, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, 12462 Athens, Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parissis', 'Affiliation': '2nd Department of Cardiology, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, 12462 Athens, Greece.'}, {'ForeName': 'Pelagia', 'Initials': 'P', 'LastName': 'Katsimbri', 'Affiliation': '4th Department of Internal Medicine, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, 12462 Athens, Greece.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Papadavid', 'Affiliation': '2nd Department of Dermatology and Venereology, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, 12462 Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': '2nd Department of Internal Medicine, Research Unit and Diabetes Center, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, 12462 Athens, Greece.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph15020172']
2543,35215262,Effects of Salicornia-Based Skin Cream Application on Healthy Humans' Experimental Model of Pain and Itching.,"Halophyte plants are salt-tolerant and are acclimated for growth in saline soils such as along coastal areas. Among the halophytes, the Salicornia species have been used as both folk medicine and functional food for many years due to their high levels of bioactive compounds with supposed anti-inflammatory and antioxidative effects. However, the properties of Salicornia bioactive extracts on pain and itching still remain unclear. In this study, 30 healthy volunteers were randomized to treatments with 10% Salicornia-based cream or placebo cream for 24 or 48 h. On day 0, and 24 or 48 h post cream application, cold/heat detection and pain thresholds, mechanical pain thresholds and sensitivity, trans-epidermal water loss, histamine- and cowhage-evoked itch, and micro-vascular reactivity (neurogenic inflammation) were assessed to evaluate the analgesic, anti-pruritogenic and vasomotor effects. Skin permeability was reduced in the Salicornia-treated area for 48 h compared with 24 h application ( p -value < 0.05). After 48 h of application, a decrease in mechanical-evoked itching (hyperkinesis) compared with 24 h treatment ( p -value < 0.05) and increased warm detection and heat pain thresholds ( p -value < 0.05) was found. Histamine-induced neurogenic inflammation showed a significant reduction in the cream-treated areas after 48 h compared with 24 h ( p -value < 0.05). The results of this study indicate the overall inhibitory effect of Salicornia on hyperkinesis (mechanically evoked itch), the analgesic effect on thermal sensation, and modulation of the skin barrier architecture. Further studies are needed for the assessment of the long-term effects.",2022,Histamine-induced neurogenic inflammation showed a significant reduction in the cream-treated areas after 48 h compared with 24 h ( p -value < 0.05).,"[""Healthy Humans' Experimental Model of Pain and Itching"", '30 healthy volunteers']","['10% Salicornia-based cream or placebo cream', 'Salicornia-Based Skin Cream Application', 'Salicornia bioactive extracts']","['warm detection and heat pain thresholds', 'analgesic, anti-pruritogenic and vasomotor effects', 'mechanical-evoked itching (hyperkinesis', 'Skin permeability', 'cold/heat detection and pain thresholds, mechanical pain thresholds and sensitivity, trans-epidermal water loss, histamine- and cowhage-evoked itch, and micro-vascular reactivity (neurogenic inflammation', 'Histamine-induced neurogenic inflammation', 'thermal sensation, and modulation of the skin barrier architecture']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0086272', 'cui_str': 'Experimental Models'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1012398', 'cui_str': 'Salicornia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3494477', 'cui_str': 'Skin Cream'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0600467', 'cui_str': 'Neurogenic Inflammation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}]",30.0,0.0151601,Histamine-induced neurogenic inflammation showed a significant reduction in the cream-treated areas after 48 h compared with 24 h ( p -value < 0.05).,"[{'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Giordano', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark.'}, {'ForeName': 'Giulia Erica', 'Initials': 'GE', 'LastName': 'Aliotta', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark.'}, {'ForeName': 'Anja Stokholm', 'Initials': 'AS', 'LastName': 'Johannesen', 'Affiliation': 'Translational Biomarkers in Pain and Precision Medicine, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Voetmann-Jensen', 'Affiliation': 'Translational Biomarkers in Pain and Precision Medicine, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark.'}, {'ForeName': 'Frederikke Hillebrand', 'Initials': 'FH', 'LastName': 'Laustsen', 'Affiliation': 'Translational Biomarkers in Pain and Precision Medicine, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark.'}, {'ForeName': 'Lasse Allermann', 'Initials': 'LA', 'LastName': 'Andersen', 'Affiliation': 'Translational Biomarkers in Pain and Precision Medicine, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Rezai', 'Affiliation': 'Translational Biomarkers in Pain and Precision Medicine, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark.'}, {'ForeName': 'Malthe', 'Initials': 'M', 'LastName': 'Fredsgaard', 'Affiliation': 'Department of Energy Technology, Aalborg University, 6700 Esbjerg, Denmark.'}, {'ForeName': 'Silvia Lo', 'Initials': 'SL', 'LastName': 'Vecchio', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Arendt-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark.'}, {'ForeName': 'Mette Hedegaard', 'Initials': 'MH', 'LastName': 'Thomsen', 'Affiliation': 'Department of Energy Technology, Aalborg University, 6700 Esbjerg, Denmark.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Stensballe', 'Affiliation': 'Translational Biomarkers in Pain and Precision Medicine, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph15020150']
2544,35216037,Interferon-β Suppresses Transcriptionally Active Parvovirus B19 Infection in Viral Cardiomyopathy: A Subgroup Analysis of the BICC-Trial.,"Human parvovirus B19 (B19V) is the predominant virus currently detected in endomyocardial biopsies (EMBs). Recent findings indicate that, specifically, transcriptionally active B19V with detectable viral RNA is of prognostic relevance in inflammatory viral cardiomyopathy. We aimed to evaluate B19V replicative status (viral RNA) and beneficial effects in a sub-collective of the prospective randomized placebo-controlled phase II multi-center BICC-Trial (Betaferon In Chronic Viral Cardiomyopathy) after interferon beta-1b (IFN-β) treatment. EMBs of  n  = 64 patients with B19V mono-infected tissue were retrospectively analyzed. Viral RNA could be detected in  n  = 18/64 (28.1%) of B19V DNA positive samples (mean age 51.7 years, 12 male), of whom  n  = 13 had been treated with IFN-ß. Five patients had received placebo. PCR analysis confirmed in follow-up that EMBs significantly reduced viral RNA loads in  n  = 11/13 (84.6%) of IFN-ß treated patients ( p  = 0.001), independently from the IFN-ß dose, in contrast to the placebo group, where viral RNA load was not affected or even increased. Consequently, a significant improvement of left ventricular ejection fraction (LVEF) after treatment with IFN-ß was observed (LVEF mean baseline 51.6 ± 14.1% vs. follow-up 61.0 ± 17.5%,  p  = 0.03). In contrast, in the placebo group, worsening of LVEF was evaluated in  n  = 4/5 (80.0%) of patients. We could show for the first-time the beneficial effects from treatment with IFN-ß, suppressing B19V viral RNA and improving the hemodynamic course. Our results need further verification in a larger prospective randomized controlled trial.",2022,"Viral RNA could be detected in  n  = 18/64 (28.1%) of B19V DNA positive samples (mean age 51.7 years, 12 male), of whom  n  = 13 had been treated with IFN-ß.","['Viral Cardiomyopathy', 'EMBs of  n  = 64 patients with B19V mono-infected tissue', 'n  = 18/64 (28.1%) of B19V DNA positive samples (mean age 51.7 years, 12 male), of whom  n  = 13 had been treated with IFN-ß']","['placebo', 'Interferon-β']","['Viral RNA', 'worsening of LVEF', 'viral RNA load', 'viral RNA loads', 'B19V replicative status (viral RNA', 'left ventricular ejection fraction (LVEF']","[{'cui': 'C0264797', 'cui_str': 'Dilated cardiomyopathy secondary to viral myocarditis'}, {'cui': 'C0189785', 'cui_str': 'Endomyocardial biopsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0035736', 'cui_str': 'Viral RNA'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",64.0,0.116935,"Viral RNA could be detected in  n  = 18/64 (28.1%) of B19V DNA positive samples (mean age 51.7 years, 12 male), of whom  n  = 13 had been treated with IFN-ß.","[{'ForeName': 'Heinz-Peter', 'Initials': 'HP', 'LastName': 'Schultheiss', 'Affiliation': 'Institute of Cardiac Diagnostics and Therapy, IKDT GmbH, 12203 Berlin, Germany.'}, {'ForeName': 'Claus-Thomas', 'Initials': 'CT', 'LastName': 'Bock', 'Affiliation': 'Division of Viral Gastroenteritis and Hepatitis Pathogens and Enteroviruses, Department of Infectious Diseases, Robert Koch Institute, 13353 Berlin, Germany.'}, {'ForeName': 'Ganna', 'Initials': 'G', 'LastName': 'Aleshcheva', 'Affiliation': 'Institute of Cardiac Diagnostics and Therapy, IKDT GmbH, 12203 Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Baumeier', 'Affiliation': 'Institute of Cardiac Diagnostics and Therapy, IKDT GmbH, 12203 Berlin, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Poller', 'Affiliation': 'Department of Cardiology, Campus Benjamin Franklin, Charité, Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Universitaetsmedizin Berlin, Corporate Member of Freie Universitaet Berlin and Humboldt-Universitaet zu Berlin, 13353 Berlin, Germany.'}, {'ForeName': 'Felicitas', 'Initials': 'F', 'LastName': 'Escher', 'Affiliation': 'Institute of Cardiac Diagnostics and Therapy, IKDT GmbH, 12203 Berlin, Germany.'}]",Viruses,['10.3390/v14020444']
2545,35216750,"Hybrid closed-loop insulin delivery versus sensor-augmented pump therapy in children aged 6-12 years: a randomised, controlled, cross-over, non-inferiority trial.","BACKGROUND


Time in range (TIR) goals are rarely met in children with type 1 diabetes, except at the cost of increased hypoglycaemia episodes. Our objective was to evaluate the safety and efficiency of the Diabeloop DBL4K (Diabeloop, Grenoble, France) hybrid closed-loop system in prepubescent children.
METHODS


We did a multicentre, open-label, randomised, controlled, non-inferiority, two-session crossover study in the paediatric endocrinology departments of three university hospitals in France and Belgium. Eligible participants were aged 6-12 years with type 1 diabetes for at least 1 year, glycated haemoglobin A 1C  9% (75 mmol/mol) or less, and insulin pump treatment for at least 3 months. Participants were randomly assigned (1:1) to a closed-loop device or sensor-augmented pump (open loop) therapy. Randomisation was by a permuted block randomisation scheme, using an interactive web-based response system, and was stratified on centre (block size 6). The assessed closed-loop device, the Diabeloop for Kids DBL4K hybrid closed-loop system, is an automated blood glucose regulation system composed of a handset, insulin pump, and continuous glucose monitor. The open-loop system is defined as a sensor-augmented pump therapy composed of the usual insulin pump used by the patient and a continuous glucose monitor. A 72-h in-patient period was followed by a 6-week home phase. After a 1-week washout period, the participants crossed over to the other device. The primary outcome, assessed in the intention-to-treat population, was the mean proportion of time spent in hypoglycaemia (3·9 mmol/L [<70 mg/dL]) during the hospital phase, with a non-inferiority margin of -2·5% (absolute value). Safety was assessed in the intention-to-treat population on a per-protocol basis. This study was registered with ClinicalTrials.gov, NCT03671915.
FINDINGS


Between May 6 and Dec 23, 2019, we included 21 participants (closed loop then open loop, n=10; open loop then closed loop, n=11). The proportion of time spent in hypoglycaemia was significantly lower with the closed-loop system than the open-loop system in both groups (2·04% [95% CI 0·44 to 3·64] vs 7·06% [5·46 to 8·66]; non-inferiority one-sided p<0·0001). No severe ketoacidosis, nor severe hyoglycaemic events or fatal adverse events occurred. All 25 adverse events (18 with the closed-loop system, seven with the open-loop system) were related to the treatment.
INTERPRETATION


The closed-loop Diabeloop system decreased hypoglycaemic episodes and provided good metabolic control in prepubescent children with type 1 diabetes, under real-life conditions. This finding supports the safe use of closed-loop technology in this paediatric population.
FUNDING


Diabeloop.
TRANSLATION


For the French translation of the abstract see Supplementary Materials section.",2022,The proportion of time spent in hypoglycaemia was significantly lower with the closed-loop system than the open-loop system in both groups (2·04% [95% CI 0·44 to 3·64] vs 7·06% [5·46 to 8·66]; non-inferiority one-sided p<0·0001).,"['children aged 6-12 years', '21 participants (closed loop then open loop, n=10; open loop then closed loop, n=11', 'prepubescent children', 'paediatric endocrinology departments of three university hospitals in France and Belgium', 'Between May 6 and Dec 23, 2019', 'Eligible participants were aged 6-12 years with type 1 diabetes for at least 1 year, glycated haemoglobin']","['Hybrid closed-loop insulin delivery versus sensor-augmented pump therapy', 'closed-loop device or sensor-augmented pump (open loop) therapy', 'Diabeloop DBL4K (Diabeloop, Grenoble, France) hybrid closed-loop system']","['Safety', 'hypoglycaemic episodes', 'intention-to-treat population', 'proportion of time spent in hypoglycaemia', 'mean proportion of time spent in hypoglycaemia', 'severe ketoacidosis, nor severe hyoglycaemic events or fatal adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0559530', 'cui_str': 'Open loop'}, {'cui': 'C1658521', 'cui_str': 'Pediatric endocrinology'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]","[{'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0559530', 'cui_str': 'Open loop'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",21.0,0.0915737,The proportion of time spent in hypoglycaemia was significantly lower with the closed-loop system than the open-loop system in both groups (2·04% [95% CI 0·44 to 3·64] vs 7·06% [5·46 to 8·66]; non-inferiority one-sided p<0·0001).,"[{'ForeName': 'Dulanjalee', 'Initials': 'D', 'LastName': 'Kariyawasam', 'Affiliation': 'Paediatric Endocrinology, Diabetology, Gynaecology Department, Necker-Enfants Malades University Hospital, Assistance Publique des Hôpitaux de Paris-Centre, Paris, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Morin', 'Affiliation': ""Paediatric Gastroenterology, Hepatology, Nutrition and Diabetology Department, Children's Center, Children Hospital, University Hospital Center of Toulouse, Toulouse, France.""}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Casteels', 'Affiliation': 'Pediatrics, University Hospitals Leuven, Leuven, Belgium; Development and Regeneration, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Le Tallec', 'Affiliation': ""Paediatric Gastroenterology, Hepatology, Nutrition and Diabetology Department, Children's Center, Children Hospital, University Hospital Center of Toulouse, Toulouse, France.""}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Sfez', 'Affiliation': ""Paediatric and Adolescent Department, Grand Hôpital de l'Est Francilien, Marne-la-Vallée, France.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Godot', 'Affiliation': 'Paediatric Endocrinology, Diabetology, Gynaecology Department, Necker-Enfants Malades University Hospital, Assistance Publique des Hôpitaux de Paris-Centre, Paris, France; Transversal Therapeutic Education Unit, Necker-Enfants Malades University Hospital, Assistance Publique des Hôpitaux de Paris-Centre, Paris, France.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Huneker', 'Affiliation': 'Diabeloop, Grenoble, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Garrec', 'Affiliation': ""Paediatric and Adolescent Department, Grand Hôpital de l'Est Francilien, Marne-la-Vallée, France.""}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Benhamou', 'Affiliation': 'Department of Endocrinology, Grenoble University Hospital, Institut National de la Santé et de la Recherche Médicale U1055, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Polak', 'Affiliation': 'Paediatric Endocrinology, Diabetology, Gynaecology Department, Necker-Enfants Malades University Hospital, Assistance Publique des Hôpitaux de Paris-Centre, Paris, France; Université de Paris, Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Charpentier', 'Affiliation': ""Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète, Évry-Courcouronnes, France.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Franc', 'Affiliation': ""Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète, Évry-Courcouronnes, France; Diabetology Department, Hôpital Sud-Francilien, Corbeil-Essonnes, France; Laboratoire de Biologie de l'Exercice pour la Performance et la Santé, Université d'Évry, Institut de Recherches Biomédicales des Armées, Université Paris Saclay, Evry, France.""}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Beltrand', 'Affiliation': 'Paediatric Endocrinology, Diabetology, Gynaecology Department, Necker-Enfants Malades University Hospital, Assistance Publique des Hôpitaux de Paris-Centre, Paris, France; Université de Paris, Paris, France. Electronic address: jacques.beltrand@aphp.fr.'}]",The Lancet. Digital health,['10.1016/S2589-7500(21)00271-5']
2546,35216714,"Testosterone, Diabetes Risk, and Diabetes Prevention in Men.","Middle-aged and older men with lower testosterone concentrations are more likely to have or to develop metabolic syndrome and type 2 diabetes. Central adiposity is a risk factor for metabolic syndrome and diabetes and predisposes to lower testosterone concentrations. Conversely, testosterone treatment reduces fat mass and insulin resistance. In a randomized controlled trial of 1007 men with either impaired glucose tolerance or newly diagnosed type 2 diabetes, 2 years of testosterone treatment on a background of lifestyle intervention reduced the risk of type 2 diabetes by 40%; this demonstrates the potential utility for testosterone pharmacotherapy to prevent diabetes in men.",2022,Middle-aged and older men with lower testosterone concentrations are more likely to have or to develop metabolic syndrome and type 2 diabetes.,"['to prevent diabetes in men', 'Men', 'Middle-aged and older men with lower testosterone concentrations', '1007 men with either impaired glucose tolerance or newly diagnosed type 2 diabetes, 2\xa0years of testosterone treatment on a background of lifestyle intervention reduced the risk of type 2 diabetes by 40']","['testosterone', 'testosterone pharmacotherapy']","['Testosterone, Diabetes Risk, and Diabetes Prevention', 'fat mass and insulin resistance']","[{'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",1007.0,0.213496,Middle-aged and older men with lower testosterone concentrations are more likely to have or to develop metabolic syndrome and type 2 diabetes.,"[{'ForeName': 'Bu B', 'Initials': 'BB', 'LastName': 'Yeap', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia 6009, Australia; Department of Endocrinology and Diabetes, Fiona Stanley Hospital, Perth, Western Australia 6150, Australia. Electronic address: bu.yeap@uwa.edu.au.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Wittert', 'Affiliation': ""Freemasons Centre for Men's Health and Wellbeing, Medical School, University of Adelaide, Adelaide, South Australia 5000, Australia; Department of Endocrinology, Royal Adelaide Hospital, Adelaide, South Australia 5000, Australia; South Australian Health and Medical Research Institute, North Terrace, Adelaide, South Australia 5000, Australia.""}]",Endocrinology and metabolism clinics of North America,['10.1016/j.ecl.2021.11.004']
2547,35216638,Feasibility of a tailored home-based exercise intervention during neoadjuvant chemotherapy in breast cancer patients.,"PURPOSE


To evaluate the feasibility of a home-based moderate-to-vigorous intensity, phased (introduction, intermediate, maintenance), exercise prescription in breast cancer patients receiving cardiotoxic neoadjuvant chemotherapy.
METHODS


Nineteen breast cancer patients were randomized to intervention or control for the duration of chemotherapy (16-24 weeks). The intervention was one aerobic exercise session at 80-90% VO 2max  for 25 min/week and 65%-75% VO 2max  for ≥ 50 min/week. Adherence to the tailored home-based program was assessed by heart rate monitors. Acceptability, tolerability, feasibility, efficacy, change in VO 2max , and patient reported outcomes, safety, and clinical events were assessed.
RESULTS


25.7% of eligible women consented (acceptability). Adherence was 87.6%. Women were not able to maintain exercise intensity as chemotherapy progressed (23.7% of exercise minutes were completed at prescribed heart rate during maintenance). Efficacy of the intervention was demonstrated by maintenance of VO 2max  (-1.0 ± 13.2%) compared to (-27.5 ± 7.4%) the control group. Further, during and after therapy, patients in the intervention arm reported less fatigue (control-baseline: 14.4 ± 15.9; midpoint: 19.0 ± 11.4; follow-up: 29.4 ± 20.0; intervention-baseline: 29.2 ± 24.6; midpoint: 24.6 ± 14.4; follow-up: 23.6 ± 11.9), impairment in activities (control-baseline: 13.7 ± 16.0; midpoint: 32.8 ± 17.0; follow-up: 58.6 ± 27.9; intervention-baseline: 38.7 ± 31.8; midpoint: 47.1 ± 27.5; follow-up: 47.5 ± 31.0), and pain (control-baseline: 80.8 ± 17.1; midpoint: 73.9 ± 20.7; follow-up: 50.7 ± 25.7; intervention-baseline: 68.7 ± 28.4; midpoint: 61.4 ± 22.5; follow-up: 65.3 ± 22.4). There were no differences in adverse events, treatment delays, or pathological complete response.
CONCLUSIONS


Neoadjuvant breast cancer patients maintained approximately one hour/week of moderate-intensity exercise over the course of their treatment. Further, this volume of exercise was sufficient to maintain fitness capacity and quality of life compared to the control group.
TRIAL REGISTRY


ClinicalTrials.gov Identifier: NCT03280836, prospectively registered 9/13/2017, https://clinicaltrials.gov/ct2/show/NCT03280836 .",2022,Efficacy of the intervention was demonstrated by maintenance of VO 2max  (-1.0 ± 13.2%) compared to (-27.5 ± 7.4%) the control group.,"['breast cancer patients', 'breast cancer patients receiving cardiotoxic neoadjuvant chemotherapy', 'Nineteen breast cancer patients', 'control-baseline: 13.7\u2009±\u200916.0; midpoint: 32.8\u2009±\u200917.0; follow-up: 58.6\u2009±\u200927.9; intervention-baseline: 38.7\u2009±\u200931.8; midpoint: 47.1\u2009±\u200927.5; follow-up: 47.5\u2009±\u200931.0), and pain (control-baseline: 80.8\u2009±\u200917.1; midpoint: 73.9\u2009±\u200920.7; follow-up: 50.7\u2009±\u200925.7; intervention-baseline: 68.7\u2009±\u200928.4; midpoint: 61.4\u2009±\u200922.5; follow-up: 65.3\u2009±\u200922.4']","['home-based moderate-to-vigorous intensity, phased (introduction, intermediate, maintenance), exercise prescription', 'tailored home-based exercise intervention', 'intervention or control for the duration of chemotherapy', 'aerobic exercise session at 80-90% VO 2max  for 25\xa0min/week and 65%-75% VO 2max  for\u2009≥']","['Acceptability, tolerability, feasibility, efficacy, change in VO 2max , and patient reported outcomes, safety, and clinical events', 'adverse events, treatment delays, or pathological complete response', 'fatigue', 'Adherence', 'impairment in activities', 'fitness capacity and quality of life']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517649', 'cui_str': '22.5'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0588464', 'cui_str': 'Exercise on prescription'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3693346', 'cui_str': 'Treatment Delay'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",19.0,0.0986072,Efficacy of the intervention was demonstrated by maintenance of VO 2max  (-1.0 ± 13.2%) compared to (-27.5 ± 7.4%) the control group.,"[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Sturgeon', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA. Kms99@psu.edu.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Smith', 'Affiliation': 'School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Federici', 'Affiliation': 'Department of Hematology/Oncology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Namratha', 'Initials': 'N', 'LastName': 'Kodali', 'Affiliation': 'Department of Hematology/Oncology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Renée', 'Initials': 'R', 'LastName': 'Kessler', 'Affiliation': 'Penn State Health Medical Group, Andrews Patel Hematology/Oncology, Harrisburg, PA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Wyluda', 'Affiliation': 'Department of Hematology/Oncology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Leah V', 'Initials': 'LV', 'LastName': 'Cream', 'Affiliation': 'Department of Hematology/Oncology, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Ky', 'Affiliation': 'School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kathryn H', 'Initials': 'KH', 'LastName': 'Schmitz', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-022-00420-6']
2548,35217193,The positive impact of 12 weeks of dance and balance training on the circulating amyloid precursor protein and serotonin concentration as well as physical and cognitive abilities in elderly women.,"BACKGROUND


The study aimed to compare the effectiveness of 12-weeks dance training with balance training on fall risk, physical and cognitive functions. The study's second aim was to evaluate the association between physical and cognitive functions with circulating markers of neurodegeneration and cognitive impairments in elders.
MATERIALS AND METHODS


30 older women (aged 73.3 ± 4.5) were randomly assigned into three groups: balance training (BG), dance training (DG) and control group (CG). To assess the study aims Time up and go test (TUG), 6 minute walk test (6MWT), determination test (DT), blood amyloid precursor protein (APP) and serotonin concentration were performed.
RESULTS


The results showed an improvement in 6MWT (p = 0.0001 for DG and BD), walking speed (p = 0.0001 for DG and BG) and TUG, only for DG (p = 0.0013). The number of correct responses in DT increased in both groups (p = 0.014 and p = 0.005, for DG and BG, respectively). In DG the increase in the total number of reactions was observed (p = 0.013). The improvement in cognitive and physical functions was associated with an increase in APP (p = 0.036 and p = 0.014) and a decrease in serotonin concentrations (p = 0.042 and p = 0.049), respectively in DG and BG.
CONCLUSION


Dance training intervention could have more benefits on elders' physical and cognitive functions. However, both trainings may be important factors modifying the concentration of circulating proteins associated with neurodegenerative and cognitive disorders.",2022,"The results showed an improvement in 6MWT (p = 0.0001 for DG and BD), walking speed (p = 0.0001 for DG and BG) and TUG, only for DG (p = 0.0013).","['elders', '30 older women (aged 73.3\u202f±\u202f4.5', 'elderly women']","['dance and balance training', 'balance training (BG), dance training (DG) and control group (CG', '12-weeks dance training with balance training', 'Dance training intervention']","['number of correct responses in DT', '6MWT', 'APP', 'total number of reactions', ""elders' physical and cognitive functions"", 'fall risk, physical and cognitive functions', 'walking speed', 'Time up and go test (TUG), 6\u202fminute walk test (6MWT), determination test (DT), blood amyloid precursor protein (APP) and serotonin concentration', 'serotonin concentrations', 'cognitive and physical functions']","[{'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0085151', 'cui_str': 'Amyloid beta Precursor Protein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",30.0,0.0104197,"The results showed an improvement in 6MWT (p = 0.0001 for DG and BD), walking speed (p = 0.0001 for DG and BG) and TUG, only for DG (p = 0.0013).","[{'ForeName': 'Ewa Aleksandra', 'Initials': 'EA', 'LastName': 'Rodziewicz-Flis', 'Affiliation': 'Department of Basic Physiotherapy, Gdansk University of Physical Education and Sport, K. Gorkiego 1 Street, 80-336 Gdansk, Poland. Electronic address: ewa.rodziewicz@awf.gda.pl.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Kawa', 'Affiliation': 'Department of Basic Physiotherapy, Gdansk University of Physical Education and Sport, K. Gorkiego 1 Street, 80-336 Gdansk, Poland. Electronic address: malgorzata.kawa@awf.gda.pl.'}, {'ForeName': 'Wojciech Romuald', 'Initials': 'WR', 'LastName': 'Skrobot', 'Affiliation': 'Department of Clinical Physiotherapy, Gdansk University of Physical Education and Sport, K. Gorkiego 1 Street, 80-336 Gdansk, Poland. Electronic address: wojciech.skrobot@awf.gda.pl.'}, {'ForeName': 'Damian Józef', 'Initials': 'DJ', 'LastName': 'Flis', 'Affiliation': 'Department of Pharmaceutical Pathophysiology, Medical University of Gdansk, Debinki 1 Street, 80-211 Gdansk, Poland. Electronic address: damian.flis@gumed.edu.pl.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Wilczyńska', 'Affiliation': 'Department of Psychology, Gdansk University of Physical Education and Sport, K. Gorkiego 1 Street, 80-336 Gdansk, Poland. Electronic address: dominika.wilczynska@awf.gda.pl.'}, {'ForeName': 'Marzena', 'Initials': 'M', 'LastName': 'Szaro-Truchan', 'Affiliation': 'Department of Basic Physiotherapy, Gdansk University of Physical Education and Sport, K. Gorkiego 1 Street, 80-336 Gdansk, Poland. Electronic address: marzena.szaro-truchan@awf.gda.pl.'}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Bolek-Adamek', 'Affiliation': 'Department of Fitness, Gdansk University of Physical Education and Sport, K. Gorkiego 1 Street, 80-336 Gdansk, Poland. Electronic address: justyna.bolek@awf.gda.pl.'}, {'ForeName': 'Jan Jacek', 'Initials': 'JJ', 'LastName': 'Kaczor', 'Affiliation': 'Department of Animal and Human Physiology, University of Gdansk, J Bazynskiego 8 Street, 80-308 Gdansk, Poland. Electronic address: jan.kaczor@ug.edu.pl.'}]",Experimental gerontology,['10.1016/j.exger.2022.111746']
2549,35217440,Neurological safety of subcutaneous tanezumab versus NSAID in patients with osteoarthritis.,"OBJECTIVE


To assess the long-term neurological safety of tanezumab, a monoclonal antibody against nerve growth factor.
METHODS


Patients with osteoarthritis of the hip or knee received stable doses of oral nonsteroidal anti-inflammatory drugs (NSAIDs) before study entry and during a ≤ 37-day screening period. Patients were randomized 1:1:1 to double-dummy tanezumab (2.5 mg or 5 mg, subcutaneous every 8 weeks) or oral NSAIDs (twice-daily) for 56 weeks, with a 24-week follow-up. Neurological safety evaluation focused on peripheral and sympathetic adverse events (AEs), neurologic examinations, and consultations with blinded, external diagnostic reviews.
RESULTS


During the treatment period, 6.2%, 9.0%, and 4.6% of patients experienced AEs of abnormal peripheral sensation (APS) in the tanezumab 2.5 mg, 5 mg, and NSAID groups, respectively. Hypoesthesia, paresthesia, and carpal tunnel syndrome were the most common AEs of APS. Clinically significant worsening on examination occurred in <1% in any treatment group at the last study assessment. Diagnoses following external neurological consultation included mononeuropathy (1.3%, 2.1%, and 1.0%), radiculopathy (0.9%, 0.4%, and 0.5%), and polyneuropathy (0.3%, 0.5%, and 0%) in tanezumab 2.5 mg, 5 mg, and NSAID groups, respectively. AEs potentially associated with sympathetic neuropathy were reported for 1.8%, 2.3%, and 2.9% of patients in the tanezumab 2.5 mg, 5 mg, and NSAID groups, respectively. No patient was diagnosed with sympathetic neuropathy.
CONCLUSION


Tanezumab had an increased incidence of AEs of APS versus NSAID; these were typically mild/moderate in severity, resolved during the study, and rarely resulted in discontinuation. Tanezumab was not associated with peripheral neuropathy and did not adversely affect the sympathetic nervous system.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT02528188 (https://clinicaltrials.gov/ct2/show/NCT02528188).",2022,"Tanezumab was not associated with peripheral neuropathy and did not adversely affect the sympathetic nervous system.
","['patients with osteoarthritis', 'Patients with osteoarthritis of the hip or knee received stable doses of']","['subcutaneous tanezumab versus NSAID', 'tanezumab', 'double-dummy tanezumab (2.5\xa0mg or 5\xa0mg, subcutaneous every 8\xa0weeks) or oral NSAIDs', 'Tanezumab', 'oral nonsteroidal anti-inflammatory drugs (NSAIDs']","['abnormal peripheral sensation (APS', 'incidence of AEs of APS versus NSAID', 'examination', 'polyneuropathy', 'radiculopathy', 'peripheral and sympathetic adverse events (AEs), neurologic examinations, and consultations with blinded, external diagnostic reviews', 'sympathetic neuropathy', 'Neurological safety', 'Hypoesthesia, paresthesia, and carpal tunnel syndrome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C2346819', 'cui_str': 'tanezumab'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0585337', 'cui_str': 'Bimonthly'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}]",,0.119607,"Tanezumab was not associated with peripheral neuropathy and did not adversely affect the sympathetic nervous system.
","[{'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Brown', 'Affiliation': 'Pfizer Inc., Groton, CT, United States. Electronic address: marktbrown3@gmail.com.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Sandroni', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Low', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Gorson', 'Affiliation': ""St. Elizabeth's Medical Center, Boston, MA, United States.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Glenn C', 'Initials': 'GC', 'LastName': 'Pixton', 'Affiliation': 'Pfizer Inc., Morrisville, NC, United States.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Fountaine', 'Affiliation': 'Pfizer Inc., Groton, CT, United States.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Viktrup', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'Pfizer Inc., Groton, CT, United States.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Verburg', 'Affiliation': 'Pfizer Inc., Groton, CT, United States.'}]",Journal of the neurological sciences,['10.1016/j.jns.2022.120184']
2550,35217436,"Corrigendum to A randomised, double-blind, placebo-controlled clinical trial found that a novel herbal formula UROX® BEDTIME BUDDY assisted children for the treatment of nocturnal enuresis. Phytomedicine (2021) 153783 https://doi.org/10.1016/j.phymed.2021.153783.",,2022,,[],"['Phytomedicine (2021', 'placebo']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.631516,,"[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Schloss', 'Affiliation': 'National Centre for Naturopathic Medicine, Southern Cross University, Lismore, NSW, Australia; Australian Research Centre in Complementary and Integrative Medicine, Faculty of Health, University of Technology Sydney, Sydney Australia. Electronic address: janet.schloss@scu.edu.au.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Ryan', 'Affiliation': ""The Royal Brisbane Women's Hospital, Herston, Brisbane, Australia.""}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Steel', 'Affiliation': 'Australian Research Centre in Complementary and Integrative Medicine, Faculty of Health, University of Technology Sydney, Sydney Australia.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2022.153992']
2551,35217408,The positive effect of malaria IPTp-SP on birthweight is mediated by gestational weight gain but modifiable by maternal carriage of enteric pathogens.,"BACKGROUND


Poor pregnancy and birth outcomes are common in sub-Saharan Africa and have complex aetiologies. Sulfadoxine-pyrimethamine (SP), given for intermittent preventive therapy of malaria in pregnancy (IPTp), is one of few existing interventions that improves outcomes of both mother and baby despite widespread SP-resistant malaria. Compelling evidence exists that malaria-independent pathways contribute to this protective effect, but the exact sources of non anti-malarial protection remained unknown. We hypothesized that the beneficial effect of SP on birthweight is mediated by SP activity on maternal factors, including increased gestational weight gain and antibiotic activity on pathogens in the maternal gut.
METHODS


Expectant mothers from a larger randomized control trial comparing the efficacy of IPTp-SP to IPTp with dihydroartemisinin-piperaquine (DP) were also enrolled in this sub-study study at their first antenatal care visit before commencement of IPTp (n = 105). Participants were followed monthly until delivery. Weights and mid-to-upper-arm circumferences (MUAC) were recorded. Monthly stool samples were collected and screened for five Escherichia coli pathotypes, Shigella spp., Vibrio cholerae, Salmonella, Campylobacter coli/jejuni, and three protozoa (Giardia spp., Entameba histolytica, and Cryptosporidium spp.) using previously validated molecular assays.
FINDINGS


IPTp-SP vs. IPTP-DP was associated with higher maternal gestational weight gain (GWG) and nutritional indicators (MUAC and body-mass index, BMI). GWG was found to be a mediator of the birthweight and IPTp-SP relationship, as the birthweight of SP infants, but not DP infants, varied according to maternal GWG. The burden of maternal enteric infections was high. The three most commonly observed pathogens were enteroaggregative E. coli (EAEC), atypical enteropathogenic E.coli/enterohaemorrhagic E. coli (aEPEC/EHEC), and typical enteropathogenic E.coli (tEPEC). We found that SP reduced the prevalence of EAEC in a dose-dependent manner. After 3 or more doses, SP-recipients were 90% less likely to be infected with EAEC compared to DP-recipients (OR adj  = 0.07, CI95 = 0.12, 0.39, p = 0.002). Compared to DP, this coincided with higher maternal gestational weight gain (GWG) and nutritional indicators (MUAC and body-mass index, BMI). The beneficial effect of SP on maternal GWG, MUAC and BMI, was lower if SP mothers had detectable EAEC, aEPEC/EHEC, tEPEC, and LT-ETEC at baseline. Maternal EAEC and tEPEC at baseline associated with lower birthweight for babies of both SP mothers and DP mothers. When comparing IPTp regimens, the positive effect of SP on birthweight compared to DP was only observed for infants of women who did not test positive for EAEC at baseline (adjusted mean birthweight difference SP vs. DP = 156.0 g, CI95 = -18.0 g, 336.9 g, p = 0.087), though confidence intervals crossed the null.
INTERPRETATION


Our findings indicate that in pregnant Malawian women, IPTp-SP vs. IPTp-DP is consistently associated with higher MUAC, BMI, and GWG following the WHO-recommended regimen of at least 3 doses, but carriage of maternal gut pathogens before initiation of IPTp lessens this effect. Because GWG was a mediator of the association between birthweight and SP, we show that SP's previously proven positive effect on birthweight is by promoting maternal weight gain. Overall, our results present one plausible pathway SP exerts malaria-independent protection against poor birth outcomes in the context of its waning antimalarial activity and warrants further investigation.
FUNDING


A full list of funding bodies that contributed to this study can be found in the Acknowledgements section.",2022,"IPTp-SP vs. IPTP-DP was associated with higher maternal gestational weight gain (GWG) and nutritional indicators (MUAC and body-mass index, BMI).","['DP) were also enrolled in this sub-study study at their first antenatal care visit before commencement of IPTp (n\xa0=\xa0105', 'malaria in pregnancy (IPTp', 'Expectant mothers']","['IPTp-SP to IPTp with dihydroartemisinin-piperaquine', 'IPTp-SP vs. IPTP-DP', 'Sulfadoxine-pyrimethamine (SP']","['maternal gestational weight gain (GWG) and nutritional indicators (MUAC and body-mass index, BMI', 'Weights and mid-to-upper-arm circumferences (MUAC', 'enteroaggregative E. coli (EAEC), atypical enteropathogenic E.coli/enterohaemorrhagic E. coli (aEPEC/EHEC), and typical enteropathogenic E.coli', 'prevalence of EAEC', 'Maternal EAEC and tEPEC', 'burden of maternal enteric infections', 'maternal GWG, MUAC and BMI', 'gestational weight gain and antibiotic activity']","[{'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0747820', 'cui_str': 'Malaria, antepartum'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0872165', 'cui_str': 'Enteroaggregative Escherichia coli'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0444749', 'cui_str': 'Enteropathogenic'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",105.0,0.0470746,"IPTp-SP vs. IPTP-DP was associated with higher maternal gestational weight gain (GWG) and nutritional indicators (MUAC and body-mass index, BMI).","[{'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Waltmann', 'Affiliation': 'Institute for Global Health and Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill, NC, USA. Electronic address: waltmann@email.unc.edu.'}, {'ForeName': 'Elizabeth T Rogawski', 'Initials': 'ETR', 'LastName': 'McQuade', 'Affiliation': 'Division of Infectious Diseases & International Health, Department of Medicine, University of Virginia, VA, USA.'}, {'ForeName': 'Jobiba', 'Initials': 'J', 'LastName': 'Chinkhumba', 'Affiliation': 'Malaria Alert Centre (MAC), University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Darwin J', 'Initials': 'DJ', 'LastName': 'Operario', 'Affiliation': 'Division of Infectious Diseases & International Health, Department of Medicine, University of Virginia, VA, USA.'}, {'ForeName': 'Enala', 'Initials': 'E', 'LastName': 'Mzembe', 'Affiliation': 'Malaria Alert Centre (MAC), University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Itoh', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kayange', 'Affiliation': 'National Malaria Control Program, Lilongwe, Malawi.'}, {'ForeName': 'Sydney M', 'Initials': 'SM', 'LastName': 'Puerto-Meredith', 'Affiliation': 'Undergraduate Biology Program, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Don P', 'Initials': 'DP', 'LastName': 'Mathanga', 'Affiliation': 'Malaria Alert Centre (MAC), University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Juliano', 'Affiliation': 'Institute for Global Health and Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill, NC, USA; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Carroll', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Luther A', 'Initials': 'LA', 'LastName': 'Bartelt', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gutman', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Meshnick', 'Affiliation': 'Institute for Global Health and Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill, NC, USA; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}]",EBioMedicine,['10.1016/j.ebiom.2022.103871']
2552,35218006,The Impact of Telephone-Based Cognitive Behavioral Therapy on Mental Health Distress and Disordered Eating Among Bariatric Surgery Patients During COVID-19: Preliminary Results from a Multisite Randomized Controlled Trial.,"BACKGROUND


Patients undergoing bariatric surgery have high rates of psychiatric comorbidity, which may increase their vulnerability to COVID-19-related mental health distress. Exacerbation of mental health distress and disordered eating could have significant negative effects on long-term weight management and quality of life for these patients if untreated.
OBJECTIVE


To determine the efficacy of a telephone-based cognitive behavioral therapy (Tele-CBT) intervention in improving depressive, anxiety, and disordered eating symptoms during COVID-19.
METHODS


Participants were recruited as part of a larger randomized controlled trial study (clinicaltrials.gov ID: NCT03315247) between March 2020 and March 2021 and randomized 1:1 to receive Tele-CBT or standard bariatric care. Outcomes of Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Emotional Eating Scale (EES), and Binge Eating Scale (BES) were measured at baseline, immediately post-intervention, and 3 months post-intervention. Linear mixed models were used to test the effect of intervention group, time, and group-by-time interaction for each outcome.
RESULTS


Eighty-one patients were included in the intention-to-treat analysis. Mean (SD) age of participants was 47.68 (9.36) years and 80.2% were female. There were significant group-by-time interactions for all outcomes and significant differences between groups across time. There were significant decreases in mean GAD-7 (p = 0.001), PHQ-9 (p < 0.001), EES-Total (p = 0.001), EES-Anger (p = 0.003), EES-Anxiety (p < 0.001), EES-Depression (p < 0.001), and BES (p = 0.002) scores for the Tele-CBT group at post-intervention and follow-up when compared to baseline and the control group.
CONCLUSION


Tele-CBT is a feasible and effective treatment for improving psychological distress and disordered eating among post-operative bariatric surgery patients during the COVID-19 pandemic.",2022,Tele-CBT is a feasible and effective treatment for improving psychological distress and disordered eating among post-operative bariatric surgery patients during the COVID-19 pandemic.,"['Mean (SD) age of participants was 47.68 (9.36) years and 80.2% were female', 'Patients undergoing bariatric surgery', 'Bariatric Surgery Patients', 'Eighty-one patients were included in the intention-to-treat analysis', 'Participants']","['Tele-CBT or standard bariatric care', 'Telephone-Based Cognitive Behavioral Therapy', 'telephone-based cognitive behavioral therapy (Tele-CBT) intervention']","['PHQ-9), Emotional Eating Scale (EES), and Binge Eating Scale (BES', 'depressive, anxiety, and disordered eating symptoms', 'Mental Health Distress and Disordered Eating', 'mean GAD-7', 'EES-Anxiety', 'EES-Total', 'BES', 'PHQ-9 ', 'Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9', 'psychological distress and disordered eating', 'EES-Depression', 'EES-Anger']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451027', 'cui_str': 'Binge eating scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]",81.0,0.160594,Tele-CBT is a feasible and effective treatment for improving psychological distress and disordered eating among post-operative bariatric surgery patients during the COVID-19 pandemic.,"[{'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Sockalingam', 'Affiliation': 'Bariatric Surgery Program, University Health Network, Toronto, ON, M5T 2S8, Canada. sanjeev.sockalingam@camh.ca.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Leung', 'Affiliation': 'Bariatric Surgery Program, University Health Network, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Centre for Addiction and Mental Health, ON, M6J 1H4, Toronto, Canada.'}, {'ForeName': 'Raed', 'Initials': 'R', 'LastName': 'Hawa', 'Affiliation': 'Bariatric Surgery Program, University Health Network, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Wnuk', 'Affiliation': 'Bariatric Surgery Program, University Health Network, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Satya', 'Initials': 'S', 'LastName': 'Dash', 'Affiliation': 'Bariatric Surgery Program, University Health Network, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Jackson', 'Affiliation': 'Bariatric Surgery Program, University Health Network, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Cassin', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, M5T 1R8, Canada.'}]",Obesity surgery,['10.1007/s11695-022-05981-6']
2553,35218727,Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation: Rationale and Design of the RED-AF study.,"Shared decision making (SDM) improves the likelihood that patients will receive care in a manner consistent with their priorities. To facilitate SDM, decision aids (DA) are commonly used, both to prepare a patient before their clinician visit, as well as to facilitate discussion during the visit. However, the relative efficacy of patient-focused or encounter-based DAs on SDM and patient outcomes remains largely unknown. We aim to directly estimate the comparative effectiveness of two DA's on SDM observed in encounters to discuss stroke prevention strategies in patients with atrial fibrillation (AF). The study aims to recruit 1200 adult patients with non-valvular AF who qualify for anticoagulation therapy, and their clinicians who manage stroke prevention strategies, in a 2 × 2 cluster randomized multi-center trial at six sites. Two DA's were developed as interactive, online, non-linear tools: a patient decision aid (PDA) to be used by patients before the encounter, and an encounter decision aid (EDA) to be used by clinicians with their patients during the encounter. Patients will be randomized to PDA or usual care; clinicians will be randomized to EDA or usual care. Primary outcomes are quality of SDM, patient decision making, and patient knowledge. Secondary outcomes include anticoagulation choice, adherence, and clinical events. This trial is the first randomized, head-to-head comparison of the effects of an EDA versus a PDA on SDM. Our results will help to inform future SDM interventions to improve patients' AF outcomes and experiences with stroke prevention strategies.",2022,"Two DA's were developed as interactive, online, non-linear tools: a patient decision aid (PDA) to be used by patients before the encounter, and an encounter decision aid (EDA) to be used by clinicians with their patients during the encounter.","['patients with atrial fibrillation (AF', '1200 adult patients with non-valvular AF who qualify for anticoagulation therapy, and their clinicians who manage stroke prevention strategies, in a 2\u202f×\u202f2 cluster randomized multi-center trial at six sites', 'Atrial Fibrillation']","['EDA', 'Decision Support Interventions']","['quality of SDM, patient decision making, and patient knowledge', 'anticoagulation choice, adherence, and clinical events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",1200.0,0.041098,"Two DA's were developed as interactive, online, non-linear tools: a patient decision aid (PDA) to be used by patients before the encounter, and an encounter decision aid (EDA) to be used by clinicians with their patients during the encounter.","[{'ForeName': 'Aubrey E', 'Initials': 'AE', 'LastName': 'Jones', 'Affiliation': 'University of Utah School of Medicine, Department of Population Health Sciences, SLC, UT.'}, {'ForeName': 'Madeleine M', 'Initials': 'MM', 'LastName': 'McCarty', 'Affiliation': 'University of Utah School of Medicine, Department of Population Health Sciences, SLC, UT.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Brito', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Noseworthy', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Kerri L', 'Initials': 'KL', 'LastName': 'Cavanaugh', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Nephrology & Hypertension, Nashville, TN.'}, {'ForeName': 'Kenzie A', 'Initials': 'KA', 'LastName': 'Cameron', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Department of Medicine, Division of General Internal Medicine and Geriatrics, Chicago, IL.'}, {'ForeName': 'Geoffrey D', 'Initials': 'GD', 'LastName': 'Barnes', 'Affiliation': 'University of Michigan, Division of Cardiovascular Medicine, Department of Internal Medicine, Ann Arbor, MI.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Steinberg', 'Affiliation': 'University of Utah School of Medicine, Division of Cardiovascular Medicine.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Witt', 'Affiliation': 'University of Utah College of Pharmacy, Department of Pharmacotherapy, Salt Lake City, UT.'}, {'ForeName': 'George H', 'Initials': 'GH', 'LastName': 'Crossley', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, Division of Cardiology, Nashville, TN.'}, {'ForeName': 'Rod', 'Initials': 'R', 'LastName': 'Passman', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Department of Medicine, Division of Cardiology, Chicago, IL.'}, {'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Kansal', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Department of Medicine, Division of Cardiology, Chicago, IL.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Hargraves', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': 'US Department of Veterans Affairs, Department of Medicine, Nashville, TN.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jackson', 'Affiliation': 'University of Alabama Birmingham, Division of Cardiovascular Disease, Birmingham, AL.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Guzman', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Department of Medicine, Division of General Internal Medicine and Geriatrics, Chicago, IL.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ariotti', 'Affiliation': 'University of Utah School of Medicine, Department of Population Health Sciences, SLC, UT.'}, {'ForeName': 'Mandy L', 'Initials': 'ML', 'LastName': 'Pershing', 'Affiliation': 'University of Utah School of Medicine, Department of Population Health Sciences, SLC, UT.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Herrick', 'Affiliation': 'University of Utah School of Medicine, Department of Internal Medicine, Division of Epidemiology, SLC, UT.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Montori', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fagerlin', 'Affiliation': 'University of Utah School of Medicine, Department of Population Health Sciences, SLC, UT; Salt Lake City VA Informatics Decision-Enhancement and Analytic Sciences (IDEAS) Center for Innovation.'}, {'ForeName': 'Elissa M', 'Initials': 'EM', 'LastName': 'Ozanne', 'Affiliation': 'University of Utah School of Medicine, Department of Population Health Sciences, SLC, UT. Electronic address: Elissa.ozanne@hsc.utah.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2022.02.010']
2554,35219379,"Safety and efficacy of three enteral feeding strategies in patients with severe stroke in China (OPENS): a multicentre, prospective, randomised, open-label, blinded-endpoint trial.","BACKGROUND


Early enteral nutrition is crucial for preventing malnutrition and improving outcomes in patients with severe stroke, but previous trials have provided conflicting results regarding the optimal nutritional strategy. We aimed to compare the efficacy and safety of three enteral feeding strategies in patients with severe stroke.
METHODS


The Optimizing Early Enteral Nutrition in Severe Stroke (OPENS) study was a multicentre, investigator-initiated, prospective, open-label, randomised controlled trial, with blinded outcome assessment, in 16 tertiary and district general hospitals in the west of China. Adult patients with acute severe ischaemic or haemorrhagic stroke (Glasgow Coma Scale score ≤12 or National Institutes of Health Stroke Scale score ≥11 on admission) who were expected to receive enteral nutrition for more than 7 days were randomly assigned (1:1:1) to full enteral nutrition (70-100% of estimated caloric requirements), modified full enteral nutrition (full enteral nutrition plus prokinetic agents), or hypocaloric enteral nutrition (40-60% of estimated caloric requirements) via a centralised web-based randomisation system. The assigned nutrition was initiated within 24 h after enrolment and continued for 7 days. The computer-generated randomisation sequence was prepared by a statistician not involved with the rest of the study. Randomisation was done with an automated permuted block size of six. The allocation was unblinded to participants and investigators. The primary efficacy outcome was the proportion of participants with poor outcome (modified Rankin Scale score ≥3) at day 90 and the prespecified primary safety outcome was mortality at day 90, assessed in the intention-to-treat population. The trial is registered with ClinicalTrials.gov, NCT02982668.
FINDINGS


Between Jan 15, 2017, and Sept 23, 2020, 321 patients were randomly assigned (107 in each group) and 315 patients (175 [56%] men, median age 71 years, IQR 60-78) were included in the final analysis. The study was terminated ahead of schedule on Sept 23, 2020, because a significant difference between groups was detected in mortality. The proportion of participants with poor outcomes at 90 days did not differ (modified full enteral nutrition 86 [82%] of 105 patients vs full enteral nutrition 85 [80%] of 106 patients, adjusted odds ratio [OR] 0·87, 95% CI 0·41-1·86, p=0·721; hypocaloric enteral nutrition 76 [73%] of 104 patients vs full enteral nutrition 0·61, 0·30-1·27, p=0·186; hypocaloric enteral nutrition vs modified full enteral nutrition 0·70, 0·34-1·46, p=0·340). Hypocaloric enteral nutrition showed significantly higher 90-day mortality than did modified full enteral nutrition (35 [34%] of 104 patients vs 18 [17%] of 105 patients, adjusted OR 2·89, 95% CI 1·46-5·72; p=0·0023), whereas the difference was not significant between hypocaloric enteral nutrition and full enteral nutrition (24 [23%] of 106 patients; adjusted OR 1·92, 95% CI 1·00-3·69; p=0·049), and between modified full enteral nutrition and full enteral nutrition (adjusted OR 0·61, 0·29-1·28; p=0·187). The most common adverse event was pneumonia, the incidence of which showed no significant difference among groups (full enteral nutrition 82 [78%] of 105 patients, modified full enteral nutrition 83 [81%] of 103 patients, hypocaloric enteral nutrition 78 [75%] of 104 patients; p=0·625).
INTERPRETATION


In the early phase of severe stroke, modified full enteral nutrition or hypocaloric enteral nutrition did not significantly reduce the risk of a poor outcomes compared with full enteral nutrition over a 90-day period. Hypocaloric enteral nutrition might be associated with increased mortality compared with modified full enteral nutrition. Further studies are needed to investigate whether modified full enteral nutrition might be the optimal strategy.
FUNDING


Shaanxi province Key Research and Development Project.",2022,"The most common adverse event was pneumonia, the incidence of which showed no significant difference among groups (full enteral nutrition 82 [78%] of 105 patients, modified full enteral nutrition 83 [81%] of 103 patients, hypocaloric enteral nutrition 78 [75%] of 104 patients; p=0·625).
","['Adult patients with acute severe ischaemic or haemorrhagic stroke (Glasgow Coma Scale score ≤12 or National Institutes of Health Stroke Scale score ≥11 on admission) who were expected to receive enteral nutrition for more than 7 days', 'patients with severe stroke', '321 patients were randomly assigned (107 in each group) and 315 patients (175 [56%] men, median age 71 years, IQR 60-78', '16 tertiary and district general hospitals in the west of China', 'patients with severe stroke in China (OPENS', 'Between Jan 15, 2017, and Sept 23, 2020']","['hypocaloric enteral nutrition', 'full enteral nutrition (70-100% of estimated caloric requirements), modified full enteral nutrition (full enteral nutrition plus prokinetic agents), or hypocaloric enteral nutrition (40-60% of estimated caloric requirements) via a centralised web-based randomisation system', 'Hypocaloric enteral nutrition', 'enteral feeding strategies']","['proportion of participants with poor outcome (modified Rankin Scale score ≥3', 'risk of a poor outcomes', 'mortality', 'efficacy and safety', '90-day mortality', 'hypocaloric enteral nutrition and full enteral nutrition', 'Safety and efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0489460', 'cui_str': 'Energy requirement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1268865', 'cui_str': 'Prokinetic Agent'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]",321.0,0.109828,"The most common adverse event was pneumonia, the incidence of which showed no significant difference among groups (full enteral nutrition 82 [78%] of 105 patients, modified full enteral nutrition 83 [81%] of 103 patients, hypocaloric enteral nutrition 78 [75%] of 104 patients; p=0·625).
","[{'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': ""Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xi'an, China; Department of Neurology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.""}, {'ForeName': 'Changgeng', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': ""Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Yin', 'Affiliation': 'Department of Neurology, The PLA 940 Hospital, Lanzhou, China; Department of Neurology, Gansu Provincial Central Hospital, Lanzhou, China.'}, {'ForeName': 'Mingze', 'Initials': 'M', 'LastName': 'Chang', 'Affiliation': ""Department of Neurology, Xi'an No.3 Hospital, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, The First Affiliated Hospital of Xi'an Medical University, Xi'an, China.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': ""Department of Neurology, The First People's Hospital of Xianyang, Xianyang, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': ""Department of Neurology, Xi'an Gaoxing Hospital, Xi'an, China.""}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Neurology, Yulin No 1 Hospital, Yulin, China.'}, {'ForeName': 'Yongbin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, General Hospital of Xinjiang Military Command, Urumqi, China.'}, {'ForeName': 'Chengkai', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Tongchuan People's Hospital, Tongchuan, China.""}, {'ForeName': 'Chaohui', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Tongchuan Mining Bureau Hospital, Tongchuan, China.'}, {'ForeName': 'Xinlai', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Xi'an Central Hospital, Xi'an, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': ""Department of Health Statistics, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xi'an, China; The Shaanxi Cerebrovascular Disease Clinical Research Centre, Xi'an, China. Electronic address: fyangx_neuro@163.com.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': ""Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xi'an, China; The Shaanxi Cerebrovascular Disease Clinical Research Centre, Xi'an, China. Electronic address: jiangwen@fmmu.edu.cn.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(22)00010-2']
2555,35219377,"Prophylactic use of an anti-activated factor XII monoclonal antibody, garadacimab, for patients with C1-esterase inhibitor-deficient hereditary angioedema: a randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND


Hereditary angioedema is associated with dysregulation of the kallikrein-kinin system. Factor XII (FXII) is a key initiator of the kallikrein-kinin system, which produces bradykinin, a central mediator of angioedema. Garadacimab (CSL Behring) is a first-in-class, fully human, immunoglobulin G4 monoclonal antibody targeting activated FXII, intended to prevent attacks in patients with C1-esterase inhibitor-deficient hereditary angioedema (HAE-C1-INH). We aimed to investigate garadacimab as a treatment every 4 weeks for patients with HAE-C1-INH.
METHODS


In this double-blind, placebo-controlled, phase 2 study, patients with HAE-C1-INH were recruited from 12 research centres in Canada, Germany, Israel, and the USA. Eligible patients were aged 18-65 years and must have had at least four attacks of any severity over a consecutive 2-month period during the 3 months before screening or initiation of previous hereditary angioedema prophylaxis. After a run-in period of 4-8 weeks, patients were randomly assigned (1:1:1:1), using an interactive response technology via block randomisation (block sizes of 1-4), to either placebo or 75 mg, 200 mg, or 600 mg garadacimab. Patients were given an initial intravenous loading dose, and then, on day 6 and every 4 weeks for 12 weeks, they were given a subcutaneous dose of their allocated treatment. The primary endpoint was the number of monthly attacks in the intention-to-treat population (defined as all patients who underwent screening, provided consent, and were assigned to treatment) during the 12-week subcutaneous administration period assessed in the 200 mg and 600 mg garadacimab groups versus placebo. Safety was assessed in all patients who received at least one dose or partial dose of study treatment. This study is registered with ClinicalTrials.gov, NCT03712228.
FINDINGS


Between Oct 29, 2018, and Aug 28, 2019, 54 patients were screened, of whom 32 were randomly assigned to either placebo (n=8) or 75 mg (n=9), 200 mg (n=8), or 600 mg (n=7) garadacimab. The median age was 39·5 years (28·0-52·5) and 18 (56%) of 32 patients were female and 14 (34%) were male. The median number of monthly attacks during the 12-week subcutaneous treatment period was 4·6 (IQR 3·1-5·0) with placebo, 0·0 (0·0-0·4) with 75 mg garadacimab, 0·0 (0·0-0·0) with 200 mg garadacimab, and 0·3 (0·0-0·7) with 600 mg garadacimab. Compared with placebo, the rate of attacks was significantly reduced with garadacimab at 200 mg (reduced by 100% [95% CI 98-101]; p=0·0002) and 600 mg (reduced by 93% [54-110]; p=0·0003). No serious adverse events, deaths, or adverse events of special interest (anaphylaxis, thromboembolic events, and bleeding events) were observed.
INTERPRETATION


Garadacimab 200 mg and 600 mg every 4 weeks significantly reduced the number of monthly attacks versus placebo and was well tolerated during the study. Garadacimab is an efficacious, subcutaneous prophylaxis in patients with HAE-C1-INH and warrants phase 3 evaluation.
FUNDING


CSL Behring.",2022,"No serious adverse events, deaths, or adverse events of special interest (anaphylaxis, thromboembolic events, and bleeding events) were observed.
","['patients with C1-esterase inhibitor-deficient hereditary angioedema', 'patients with HAE-C1-INH and warrants phase 3 evaluation', 'patients with HAE-C1-INH were recruited from 12 research centres in Canada, Germany, Israel, and the USA', 'patients with C1-esterase inhibitor-deficient hereditary angioedema (HAE-C1-INH', 'The median age was 39·5 years (28·0-52·5) and 18 (56%) of 32 patients were female and 14 (34%) were male', 'Between Oct 29, 2018, and Aug 28, 2019, 54 patients were screened, of whom 32', 'patients with HAE-C1-INH', 'Eligible patients were aged 18-65 years and must have had at least four attacks of any severity over a consecutive 2-month period during the 3 months before screening or initiation of previous hereditary angioedema prophylaxis']","['garadacimab groups versus placebo', 'Factor XII (FXII', 'placebo', 'placebo, 0·0', 'anti-activated factor XII monoclonal antibody, garadacimab']","['serious adverse events, deaths, or adverse events of special interest (anaphylaxis, thromboembolic events, and bleeding events', 'Safety', 'rate of attacks', 'number of monthly attacks in the intention-to-treat population', 'median number of monthly attacks', 'number of monthly attacks']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009500', 'cui_str': 'Complement Component 1 Inactivator Proteins'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015525', 'cui_str': 'Coagulation factor XII'}, {'cui': 'C0015527', 'cui_str': 'Coagulation factor XIIa'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",54.0,0.232135,"No serious adverse events, deaths, or adverse events of special interest (anaphylaxis, thromboembolic events, and bleeding events) were observed.
","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Craig', 'Affiliation': 'Allergy, Asthma and Immunology, Department of Medicine and Pediatrics, Penn State University, Hershey, PA, USA. Electronic address: tcraig@pennstatehealth.psu.edu.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Magerl', 'Affiliation': 'Institute of Allergology, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Donald S', 'Initials': 'DS', 'LastName': 'Levy', 'Affiliation': 'Division of Allergy and Immunology, University of California, Irvine, CA, USA.'}, {'ForeName': 'Avner', 'Initials': 'A', 'LastName': 'Reshef', 'Affiliation': 'Allergy, Immunology and Angioedema Center, Barzilai University Hospital, Ashkelon, Israel.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Lumry', 'Affiliation': 'AARA Research Center, Dallas, TX, USA.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Martinez-Saguer', 'Affiliation': 'HZRM Haemophilia Center Rhein Main, Mörfelden-Walldorf, Germany.'}, {'ForeName': 'Joshua S', 'Initials': 'JS', 'LastName': 'Jacobs', 'Affiliation': 'Allergy and Asthma Clinical Research, Walnut Creek, CA, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Yang', 'Affiliation': 'Ottawa Allergy Research Corporation, Department of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Ritchie', 'Affiliation': 'Division of Hematology, Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Aygören-Pürsün', 'Affiliation': 'Department of Children and Adolescents, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Keith', 'Affiliation': 'McMaster University Medical Centre Site, Hamilton, ON, Canada.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Busse', 'Affiliation': 'Division of Clinical Immunology and Allergy, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Henrike', 'Initials': 'H', 'LastName': 'Feuersenger', 'Affiliation': 'CSL Behring Innovation GmbH, Marburg, Germany.'}, {'ForeName': 'Dipti', 'Initials': 'D', 'LastName': 'Pawaskar', 'Affiliation': 'CSL Behring, King of Prussia, PA, USA; Janssen Research & Development LLC, Spring House, PA, USA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Jacobs', 'Affiliation': 'CSL Behring, King of Prussia, PA, USA.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Pragst', 'Affiliation': 'CSL Behring Innovation GmbH, Marburg, Germany.'}, {'ForeName': 'Mittie K', 'Initials': 'MK', 'LastName': 'Doyle', 'Affiliation': 'CSL Behring, King of Prussia, PA, USA; Aro Biotherapeutics, Philadelphia, PA, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(21)02225-X']
2556,35219340,Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program.,"BACKGROUND


The Scleroderma Patient-centered Intervention Network (SPIN) developed an online self-management program (SPIN-SELF) designed to improve disease-management self-efficacy in people with systemic sclerosis (SSc, or scleroderma). The aim of this study was to evaluate feasibility aspects for conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF Program.
METHODS


This feasibility trial was embedded in the SPIN Cohort and utilized the cohort multiple RCT design. In this design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about the trial. Participants in the intervention arm are informed and provide consent, but not the control group. Forty English-speaking SPIN Cohort participants from Canada, the USA, or the UK with low disease-management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale [SEMCD] score ≤ 7) who were interested in using an online self-management program were randomized (3:2 ratio) to be offered the SPIN-SELF Program or usual care for 3 months. Program usage was examined via automated usage logs. User satisfaction was assessed with semi-structured interviews. Trial personnel time requirements and implementation challenges were logged.
RESULTS


Of 40 SPIN Cohort participants randomized, 26 were allocated to SPIN-SELF and 14 to usual care. Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly, except that two participants with SEMCD scores > 7 (scores of 7.2 and 7.3, respectively) were included, which was caused by a system programming error that rounded SEMCD scores. Of 26 SPIN Cohort participants offered the SPIN-SELF Program, only 9 (35%) consented to use the program. Usage logs showed that use of the SPIN-SELF Program was low: 2 of 9 users (22%) logged into the program only once (median = 3), and 4 of 9 (44%) accessed none or only 1 of the 9 program's modules (median = 2).
CONCLUSIONS


The results of this study will lead to substantial changes for the planned full-scale RCT of the SPIN-SELF Program that we will incorporate into a planned additional feasibility trial with progression to a full-scale trial. These changes include transitioning to a conventional RCT design with pre-randomization consent and supplementing the online self-help with peer-facilitated videoconference-based groups to enhance engagement.
TRIAL REGISTRATION


clinicaltrials.gov , NCT03914781 . Registered 16 April 2019.",2022,"Usage logs showed that use of the SPIN-SELF Program was low: 2 of 9 users (22%) logged into the program only once (median = 3), and 4 of 9 (44%) accessed none or only 1 of the 9 program's modules (median = 2).
","['people with systemic sclerosis (SSc, or scleroderma', 'Forty English-speaking SPIN Cohort participants from Canada, the USA, or the UK with low disease-management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale [SEMCD] score ≤ 7) who were interested in using an online self-management program']","['Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program', 'SPIN-SELF', 'SPIN-SELF Program', 'SPIN-SELF Program or usual care for 3 months']",['User satisfaction'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0324762,"Usage logs showed that use of the SPIN-SELF Program was low: 2 of 9 users (22%) logged into the program only once (median = 3), and 4 of 9 (44%) accessed none or only 1 of the 9 program's modules (median = 2).
","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kwakkenbos', 'Affiliation': 'Department of Clinical Psychology, Radboud University, Montessorilaan 3, 6525, HR, Nijmegen, The Netherlands. kwakkenbosl@gmail.com.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Østbø', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Carrier', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Warren R', 'Initials': 'WR', 'LastName': 'Nielson', 'Affiliation': ""St. Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Fedoruk', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Levis', 'Affiliation': 'Centre for Prognosis Research, School of Medicine, Keele University, Staffordshire, UK.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Henry', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Pope', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Frech', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Gholizadeh', 'Affiliation': 'California School of Professional Psychology/Alliant, Los Angeles, CA, USA.'}, {'ForeName': 'Sindhu R', 'Initials': 'SR', 'LastName': 'Johnson', 'Affiliation': 'Toronto Scleroderma Program, Mount Sinai Hospital & Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Piotrowski', 'Affiliation': 'Private practice - Nutrition, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Jewett', 'Affiliation': 'Department of Psychology, Institute of Community and Family Psychiatry, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gordon', 'Affiliation': 'Department of Medicine, Hospital for Special Surgery, New York City, NY, USA.'}, {'ForeName': 'Lorinda', 'Initials': 'L', 'LastName': 'Chung', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bilsker', 'Affiliation': 'Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Turner', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cumin', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Joep', 'Initials': 'J', 'LastName': 'Welling', 'Affiliation': 'NVLE Dutch patient organization for Systemic Autoimmune Diseases, Utrecht, The Netherlands.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fortuné', 'Affiliation': 'Ottawa Scleroderma Support Group, Ottawa, Ontario, Canada.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Leite', 'Affiliation': 'University of Minho, Braga, Portugal.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gottesman', 'Affiliation': 'Scleroderma Foundation, Los Angeles, CA, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sauvé', 'Affiliation': 'Scleroderma Canada, Hamilton, Ontario, Canada.'}, {'ForeName': 'Tatiana Sofia Rodriguez', 'Initials': 'TSR', 'LastName': 'Reyna', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico, Mexico.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hudson', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Larche', 'Affiliation': ""Department of Medicine, McMaster University and St Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Ward', 'Initials': 'W', 'LastName': 'van Breda', 'Affiliation': 'Faculty of Behavioural and Movement Sciences, Vrije University, Amsterdam, The Netherlands.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Suarez-Almazor', 'Affiliation': 'Department of General Internal Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Bartlett', 'Affiliation': 'Department of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Malcarne', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Maureen D', 'Initials': 'MD', 'LastName': 'Mayes', 'Affiliation': 'Department of Internal Medicine, University of Texas McGovern School of Medicine, Houston, TX, USA.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutron', 'Affiliation': 'Université de Paris, Centre of Research Epidemiology and Statistics (CRESS), Inserm, INRA, Paris, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Mouthon', 'Affiliation': ""Service de Médecine Interne, Centre de Référence Maladies Autoimmunes Systémiques Rares d'Ile de France, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Department of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pilot and feasibility studies,['10.1186/s40814-022-00994-5']
2557,35219336,The effects of continuous care model using a smartphone application on adherence to treatment and self-efficacy among patients with multiple sclerosis.,"BACKGROUND


Adherence to disease-modifying therapy is important in patients with Multiple Sclerosis (MS) to increase the positive outcomes and improve the quality of life. This study aimed to determine the effects of Continuous Care Model (CCM) using a smartphone application on adherence to treatment and self-efficacy among MS patients.
METHODS


This quasi-experimental study with pre/posttest design was conducted on 72 MS patients in Shiraz, Iran from June 2020 to August 2021. The samples were randomly assigned to intervention (n = 36) and control (n = 36) groups. In the intervention group, the CCM using a smartphone application was implemented during two months. However, no intervention was performed for the control group. The data were collected using the self-report Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) and MS Self-Efficacy Scale (MSSS) at baseline and two and four months after the intervention.
RESULTS


The results showed an improvement in adherence to treatment and self-efficacy in the intervention group compared to the control group after implementing the virtual CCM and at the two-month follow-up (p < 0.001).
CONCLUSIONS


Implementing the CCM using a smartphone application resulted in improvements in the MS patients' adherence to treatment and self-efficacy. It can be concluded that providing care using an interactive multimedia application can improve the outcomes as well as patients' satisfaction, especially during the COVID-19 pandemic. Therefore, this approach is recommended to be used for nurses, healthcare providers, and clinicians.",2022,"It can be concluded that providing care using an interactive multimedia application can improve the outcomes as well as patients' satisfaction, especially during the COVID-19 pandemic.","['MS patients', '72 MS patients in Shiraz, Iran from June 2020 to August 2021', 'patients with Multiple Sclerosis (MS', 'patients with multiple sclerosis']","['Continuous Care Model (CCM', 'smartphone application']","[""MS patients' adherence to treatment and self-efficacy"", 'self-report Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) and MS Self-Efficacy Scale (MSSS', 'adherence to treatment and self-efficacy', 'quality of life']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.00931336,"It can be concluded that providing care using an interactive multimedia application can improve the outcomes as well as patients' satisfaction, especially during the COVID-19 pandemic.","[{'ForeName': 'Seyed Mojtaba', 'Initials': 'SM', 'LastName': 'Kazemi', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Rakhshan', 'Affiliation': 'Community Based Psychiatric Care Research Center, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Rivaz', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran. mrivaz@sums.ac.ir.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Izadi', 'Affiliation': 'Clinical Neurology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",BMC medical informatics and decision making,['10.1186/s12911-022-01785-x']
2558,35222700,"Effect of intravenous thrombolysis combined with mild hypothermia on the levels of IL-1β, IL-6, ICAM-1 and MMP-2 in patients with acute cerebral infarction and clinical significance.","The present study aimed to explore the effects and clinical importance of serum interleukin (IL) IL-1β, IL-6, C-reactive protein (CRP), intercellular adhesion molecule (ICAM)-1 and matrix metalloproteinase (MMP)-2 in patients with acute cerebral infarction undergoing intravenous thrombolysis during simultaneous hypothermia therapy. A total of 80 patients with acute cerebral infarction who were treated at our hospital were randomly selected. They were divided into groups A and B. The two groups were treated with intravenous thrombolysis, while group B received sub-hypothermia treatment. Prior to treatment and at 7 days after treatment, 5 ml of venous blood was collected and stored in a freezer at -80˚C. IL-1β, IL-6, CRP, ICAM-1 and MMP-2 levels were detected by ELISA and compared between the groups and time-points. The results were as follows: i) At 7 days after treatment, the levels of IL-1β, IL-6, CRP, ICAM-1 and MMP-2 in group B were significantly decreased compared with those in group A (P<0.05), while there was no significant difference of these levels between group A and B before treatment (P>0.05). The incidence of adverse reactions in group A and group B was 35 and 20% respectively, and the mortality rate was 10 and 5%, respectively. There were no significant differences in adverse events and mortality between the two groups (P>0.05). In addition, a positive correlation of the level of IL-1β, IL-6, CRP, ICAM-1 and MMP-2 with the National Institutes of Health Stroke Scale score was determined in the patients prior to treatment. In conclusion, mild hypothermia treatment in addition to intravenous thrombolysis significantly reduced the levels of IL-1β, IL-6, CRP, ICAM-1 and MMP-2 in patients with acute cerebral infarction and reduced inflammation, and should therefore be incorporated in clinical practice.",2022,"At 7 days after treatment, the levels of IL-1β, IL-6, CRP, ICAM-1 and MMP-2 in group B were significantly decreased compared with those in group A (P<0.05), while there was no significant difference of these levels between group A and B before treatment (P>0.05).","['patients with acute cerebral infarction and clinical significance', 'patients with acute cerebral infarction undergoing intravenous thrombolysis during simultaneous hypothermia therapy', 'patients with acute cerebral infarction', '80 patients with acute cerebral infarction who were treated at our hospital were randomly selected']","['intravenous thrombolysis', 'intravenous thrombolysis combined with mild hypothermia', 'serum interleukin (IL) IL-1β, IL-6, C-reactive protein (CRP), intercellular adhesion molecule (ICAM)-1 and matrix metalloproteinase (MMP)-2', 'sub-hypothermia treatment']","['IL-6, CRP, ICAM-1 and MMP-2 levels', 'incidence of adverse reactions', 'levels of IL-1β, IL-6, ICAM-1 and MMP-2', 'level of IL-1β, IL-6, CRP, ICAM-1 and MMP-2 with the National Institutes of Health Stroke Scale score', 'adverse events and mortality', 'levels of IL-1β, IL-6, CRP, ICAM-1 and MMP-2', 'mortality rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0445043', 'cui_str': 'Mild hypothermia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0172537', 'cui_str': 'Gelatinase A'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0150255', 'cui_str': 'Treatment of hypothermia'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0172537', 'cui_str': 'Gelatinase A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C3472498', 'cui_str': 'National Institutes of Health stroke scale score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",80.0,0.0671043,"At 7 days after treatment, the levels of IL-1β, IL-6, CRP, ICAM-1 and MMP-2 in group B were significantly decreased compared with those in group A (P<0.05), while there was no significant difference of these levels between group A and B before treatment (P>0.05).","[{'ForeName': 'Chaosheng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Wuxi Third People's Hospital, Wuxi, Jiangsu 214000, P.R. China.""}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': ""Department of Neurology, Wuxi Third People's Hospital, Wuxi, Jiangsu 214000, P.R. China.""}, {'ForeName': 'Jilai', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurology, Wuxi Third People's Hospital, Wuxi, Jiangsu 214000, P.R. China.""}, {'ForeName': 'Meiqi', 'Initials': 'M', 'LastName': 'Di', 'Affiliation': ""Department of Neurology, Wuxi Third People's Hospital, Wuxi, Jiangsu 214000, P.R. China.""}, {'ForeName': 'Changyan', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': ""Department of Neurology, Wuxi Third People's Hospital, Wuxi, Jiangsu 214000, P.R. China.""}, {'ForeName': 'Likun', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': ""Department of Neurology, Wuxi Third People's Hospital, Wuxi, Jiangsu 214000, P.R. China.""}, {'ForeName': 'Xuying', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, P.R. China.'}]",Experimental and therapeutic medicine,['10.3892/etm.2022.11147']
2559,35222693,Long-term effect of moxibustion on irritable bowel syndrome with diarrhea: a randomized clinical trial.,"Background


Moxibustion is increasingly used for treatment of irritable bowel syndrome (IBS). This study investigated the long-term effects of moxibustion for IBS with diarrhea (IBS-D).
Methods


Patients with IBS-D were assigned to receive moxibustion or sham moxibustion (52 each, 3× per week, 6 weeks) and were followed up to 24 weeks. The acupoints were bilateral ST25 and ST36, body surface temperatures at acupoints were 43°C ± 1°C and 37°C ± 1°C for the moxibustion and sham groups, respectively. Primary outcome was changes in IBS Adequate Relief (IBS-AR) from baseline to 6 weeks. Secondary outcomes included the following: IBS symptom severity scale (IBS-SSS), Bristol stool form scale (BSS), IBS quality of life (IBS-QOL), and Hospital Anxiety and Depression Scale (HADS).
Results


Based on an intention-to-treat analysis, the rate of IBS-AR in the moxibustion group was significantly higher than the sham group at 6 weeks (76.9%  versus  42.3%;  p  < 0.001); the mean decrease of total IBS-BSS score in the moxibustion group was lower than that of the sham group (-116.9  versus  -61.5;  p  < 0.001), both of which maintained throughout the follow-up period. Five specific domains of the IBS-SSS were lower in the moxibustion group than the sham, throughout ( p  < 0.001). At week 6, the rate of reduction >50 points in IBS-SSS of the treatment group was significantly higher than that of the sham ( p  < 0.001), which persisted throughout the follow-up period. Similar long-lasting improvements were observed in BSS, stool frequency, and stool urgency ( p  < 0.001). Improvements of IBS-QOL and HADS were comparable between the groups.
Conclusions


Moxibustion treatment benefits the long-term relief of symptoms in IBS-D patients.
Trial registration


Clinical trials.gov (NCT02421627). Registered on 20 April 2015.",2022,"Five specific domains of the IBS-SSS were lower in the moxibustion group than the sham, throughout ( p  < 0.001).","['irritable bowel syndrome (IBS', 'irritable bowel syndrome with diarrhea', 'Methods\n\n\nPatients with IBS-D']","['moxibustion or sham moxibustion', '\n\n\nMoxibustion', 'moxibustion']","['IBS-QOL and HADS', 'rate of IBS-AR', 'IBS-SSS', 'BSS, stool frequency, and stool urgency', 'changes in IBS Adequate Relief (IBS-AR', 'IBS symptom severity scale (IBS-SSS), Bristol stool form scale (BSS), IBS quality of life (IBS-QOL), and Hospital Anxiety and Depression Scale (HADS', 'total IBS-BSS score', 'rate of reduction >50 points in IBS-SSS']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0348898', 'cui_str': 'Irritable bowel syndrome with diarrhea'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.358239,"Five specific domains of the IBS-SSS were lower in the moxibustion group than the sham, throughout ( p  < 0.001).","[{'ForeName': 'Chunhui', 'Initials': 'C', 'LastName': 'Bao', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Luyi', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Acupuncture and Immunological Effects, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Outpatient, Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Department of Anatomy and Cell Biology, Stark Neurosciences Research Institute, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Jiacheng', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Zhihai', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai Traditional Chinese Medicine-Integrated Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Shanghai Clinical Research Center for Mental Health, Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Weng', 'Affiliation': 'Key Laboratory of Acupuncture and Immunological Effects, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jinmei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Huirong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, No. 11o, Ganhe Road, Hongkou District, Shanghai 200437, China.'}, {'ForeName': 'Huangan', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, No. 11o, Ganhe Road, Hongkou District, Shanghai 200437, China.'}]",Therapeutic advances in gastroenterology,['10.1177/17562848221075131']
2560,35222690,3D-Slicer Software-Assisted Neuroendoscopic Surgery in the Treatment of Hypertensive Cerebral Hemorrhage.,"Objective


To explore the 3D-slicer software-assisted endoscopic treatment for patients with hypertensive cerebral hemorrhage.
Methods


A total of 120 patients with hypertensive cerebral hemorrhage were selected and randomly divided into control group and 3D-slicer group with 60 cases each. Patients in the control group underwent traditional imaging positioning craniotomy, and patients in the 3D-slicer group underwent 3D-slicer followed by precision puncture treatment. In this paper, we evaluate the hematoma clearance rate, nerve function, ability of daily living, complication rate, and prognosis.
Results


The 3D-slicer group is better than the control group in various indicators. Compared with the control group, the 3D-slicer group has lower complications, slightly higher hematoma clearance rate, and better recovery of nerve function and daily living ability before and after surgery. The incidence of poor prognosis is low.
Conclusion


The 3D-slicer software-assisted endoscopic treatment for patients with hypertensive intracerebral hemorrhage has a better hematoma clearance effect, which is beneficial to the patient's early recovery and reduces the damage to the brain nerve of the patient.",2022,"The 3D-slicer software-assisted endoscopic treatment for patients with hypertensive intracerebral hemorrhage has a better hematoma clearance effect, which is beneficial to the patient's early recovery and reduces the damage to the brain nerve of the patient.","['patients with hypertensive cerebral hemorrhage', '120 patients with hypertensive cerebral hemorrhage', 'patients with hypertensive intracerebral hemorrhage', 'Hypertensive Cerebral Hemorrhage']","['control group and 3D-slicer', 'traditional imaging positioning craniotomy, and patients in the 3D-slicer group underwent 3D-slicer followed by precision puncture treatment', '3D-slicer software-assisted endoscopic treatment', '3D-Slicer Software-Assisted Neuroendoscopic Surgery']","['hematoma clearance rate, and better recovery of nerve function and daily living ability', 'hematoma clearance rate, nerve function, ability of daily living, complication rate, and prognosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751892', 'cui_str': 'Hypertensive Hemorrhage, Cerebral'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}]",120.0,0.0653153,"The 3D-slicer software-assisted endoscopic treatment for patients with hypertensive intracerebral hemorrhage has a better hematoma clearance effect, which is beneficial to the patient's early recovery and reduces the damage to the brain nerve of the patient.","[{'ForeName': 'Rongfang', 'Initials': 'R', 'LastName': 'Liao', 'Affiliation': ""The Second People's Hospital of Jingdezhen City, Jiangxi Province 333000, China.""}, {'ForeName': 'Longmao', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""The Second People's Hospital of Jingdezhen City, Jiangxi Province 333000, China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': ""The Second People's Hospital of Jingdezhen City, Jiangxi Province 333000, China.""}, {'ForeName': 'Xinhong', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': ""The Second People's Hospital of Jingdezhen City, Jiangxi Province 333000, China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""The Second People's Hospital of Jingdezhen City, Jiangxi Province 333000, China.""}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""The Second People's Hospital of Jingdezhen City, Jiangxi Province 333000, China.""}]",Computational and mathematical methods in medicine,['10.1155/2022/7156598']
2561,35222686,The Value of Gastric Cancer Staging by Endoscopic Ultrasonography Features in the Diagnosis of Gastroenterology.,"This research was aimed at exploring the application value of endoscopic ultrasonography (EUS) in the diagnosis of gastric cancer staging and the correlation between staging and clinical features of gastric cancer. A total of 72 patients with gastric cancer were selected and randomly divided into two groups. The patients in the pathological group underwent postoperative pathological examination, while those in the EUS group received preoperative EUS examination. The results showed that the staging accuracy of EUS was 73.33% for T1, 78.57% for T2, 27% for T3, and 100% for T4, compared with the pathological staging. The accuracy of N- and N+ was 42.5% and 82.3% in EUS, respectively, and the total accuracy was 55.7%. There was no considerable difference in the accuracy of T staging between early gastric cancer and advanced gastric cancer ( P  > 0.05), but there was a considerable difference in N staging ( P  < 0.05). Lymph node metastasis affected the accuracy of N staging ( P  < 0.05). The number and location of metastatic lymph nodes did not affect the judgment of metastatic lymph nodes ( P  > 0.05). In addition, the proportion of understaging and overstaging was greatly different among different lesion sizes and histological types of gastric cancer ( P  < 0.05). To sum up, the accuracy of EUS for T and N staging of gastric cancer needed to be improved. The location of gastric cancer lesions affected the accuracy of T staging, while the depth of invasion and lymph node metastasis affected the accuracy of N staging.",2022,The number and location of metastatic lymph nodes did not affect the judgment of metastatic lymph nodes ( P  > 0.05).,['72 patients with gastric cancer'],"['endoscopic ultrasonography (EUS', 'preoperative EUS examination']","['staging accuracy of EUS', 'postoperative pathological examination', 'accuracy of T staging between early gastric cancer and advanced gastric cancer', 'proportion of understaging and overstaging', 'number and location of metastatic lymph nodes', 'total accuracy', 'accuracy of N- and N']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0349530', 'cui_str': 'Early gastric cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",72.0,0.0972776,The number and location of metastatic lymph nodes did not affect the judgment of metastatic lymph nodes ( P  > 0.05).,"[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, Zibo Central Hospital, Zibo, 255000 Shandong, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Zibo Central Hospital, Zibo, 255000 Shandong, China.'}]",Computational and mathematical methods in medicine,['10.1155/2022/6192190']
2562,35222673,Salivary Fluoride Bioavailability after Brushing with Brazilian Red Propolis Dentifrice: A Clinical Study.,"Introduction


Fluoride plays an important role in the control of dental caries, and currently new dentifrices are being associated with natural products.
Objective


This study aimed to evaluate the availability of fluoride in saliva samples after using a dentifrice incorporated with Brazilian red propolis (BRP, INPI Patent no. BR1020170110974) and to compare it to a conventional fluoridated dentifrice in healthy participants.
Methods


This study was conducted implementing a double-blind, randomized, controlled, and crossover design. Saliva samples of participants were collected at the following time points: 0 at baseline and 5, 15, 30, 45, and 60 minutes after brushing with each dentifrice. Salivary fluoride concentrations showed no statistically significant difference when comparing the two treatments ( p  > 0.05). All available fluoride concentrations in saliva decreased after one hour, with no significant difference between BRP and conventional fluoridated dentifrice treatment samples ( p  > 0.05).
Results


The results showed that there was no difference between the analyzed fluoride concentrations 1 hour after brushing with the different dentifrices.
Conclusions


The results of this study suggest that the propolis incorporated in the dentifrice did not interfere with the kinetics and bioavailability of the fluoride ion in saliva samples, enabling its integration with the pharmaceutical formula and thereby promoting its anti-inflammatory and antimicrobial benefits without compromising the anticaries activity of the formulation.",2022,"All available fluoride concentrations in saliva decreased after one hour, with no significant difference between BRP and conventional fluoridated dentifrice treatment samples ( p  > 0.05).
",['healthy participants'],"['Brazilian Red Propolis Dentifrice', 'conventional fluoridated dentifrice']","['Salivary fluoride concentrations', 'Salivary Fluoride Bioavailability', 'fluoride concentrations in saliva']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}]",,0.194496,"All available fluoride concentrations in saliva decreased after one hour, with no significant difference between BRP and conventional fluoridated dentifrice treatment samples ( p  > 0.05).
","[{'ForeName': 'Francisco Josimar', 'Initials': 'FJ', 'LastName': 'Girão Júnior', 'Affiliation': 'Pharmacology Postgraduate Program, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Lidia Audrey Rocha', 'Initials': 'LAR', 'LastName': 'Valadas', 'Affiliation': 'Cátedra de Odontología Preventiva y Comunitaria, Facultad de Odontologtía, Universidad de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bottenberg', 'Affiliation': 'Department of Oral Health Sciences, Université Libre de Bruxelles (Free University of Brussels), Brussel, Belgium.'}, {'ForeName': 'Mara Assef Leitão', 'Initials': 'MAL', 'LastName': 'Lotif', 'Affiliation': 'Postgraduate Program in Drug Development, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Edilson Martins', 'Initials': 'EM', 'LastName': 'Rodrigues Neto', 'Affiliation': 'Postgraduate Program in Drug Development, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Said Gonçalves da Cruz', 'Initials': 'SGDC', 'LastName': 'Fonseca', 'Affiliation': 'Postgraduate Program in Drug Development, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Mary Anne Medeiros', 'Initials': 'MAM', 'LastName': 'Bandeira', 'Affiliation': 'Postgraduate Program in Drug Development, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Squassi', 'Affiliation': 'Cátedra de Odontología Preventiva y Comunitaria, Facultad de Odontologtía, Universidad de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Thereza Cristina Farias Botelho', 'Initials': 'TCFB', 'LastName': 'Dantas', 'Affiliation': 'Paulo Picanço College of Dentistry, Fortaleza, Brazil.'}, {'ForeName': 'Nara Juliana Custódio', 'Initials': 'NJC', 'LastName': 'de Sena', 'Affiliation': 'Postgraduate Program in Drug Development, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Marta Maria de França', 'Initials': 'MMF', 'LastName': 'Fonteles', 'Affiliation': 'Postgraduate Program in Drug Development, Federal University of Ceará, Fortaleza, Brazil.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2022/6148137']
2563,35222661,Effectiveness of prophylaxis treatment in the acute febrile stage of febrile seizure in children under five years old.,"Objectives


In children suffering from febrile seizure, the likelihood of recurrence seems to be high in the early hours following the first episodes in the absence of proper interventions. The present study was aimed at assessing and comparing the outcomes of different preventive interventions in the acute stage after febrile seizure in children.
Materials & Methods


This randomized clinical trial study was performed between September 2015 and September 2016. We enrolled patients aged between 6 and 60 months suffered from febrile seizure and referred to the Pediatric Emergency Department at Besat Hospital in Hamadan. The eligible patients were randomly assigned to the following four receive one of the following groups: group 1 (not receiving any anti-seizure drugs), group 2 (receiving a single dose of phenobarbital) on admission, group 3 (receiving a single dose of phenobarbital on admission continued until the fever is resolved), and group 4 (receiving diazepam until the disappearance of fever).
Results


The study population consisted of 248 children. The recurrence rate of seizure in the acute stage was 4.84%. Also, the impact of diazepam and phenobarbital (either as a single dose or as continuous) on the prevention of febrile seizure recurrence in the acute stage has been established. None of the patients had febrile status epilepticus.
Conclusion


Controlling seizures without prescribing anti-seizure drugs increases the risk for the recurrence of febrile seizure in the acute stage. Different drug regimens for controlling seizure, including diazepam and phenobarbital (as stat or maintenance), may play a similar role in preventing the occurrence of febrile seizure.",2022,"None of the patients had febrile status epilepticus.
","['children under five years old', 'enrolled patients aged between 6 and 60 months suffered from febrile seizure and referred to the Pediatric Emergency Department at Besat Hospital in Hamadan', '248 children', 'children suffering from febrile seizure', 'acute stage after febrile seizure in children', 'September 2015 and September 2016']","['diazepam and phenobarbital', 'prophylaxis treatment', 'group 1 (not receiving any anti-seizure drugs), group 2 (receiving a single dose of phenobarbital', 'diazepam']","['febrile status epilepticus', 'acute febrile stage of febrile seizure', 'febrile seizure recurrence', 'recurrence rate of seizure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009952', 'cui_str': 'Febrile convulsion'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0038220', 'cui_str': 'Status epilepticus'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009952', 'cui_str': 'Febrile convulsion'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}]",248.0,0.127976,"None of the patients had febrile status epilepticus.
","[{'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Fayyazi', 'Affiliation': 'Department of Pediatrics,\xa0School of Medicine,\xa0Hamadan University of Medical Sciences,\xa0Hamadan,\xa0Iran.'}, {'ForeName': 'Nasrollah', 'Initials': 'N', 'LastName': 'Pezeshki', 'Affiliation': 'Department of Pediatrics,\xa0School of Medicine,\xa0Hamadan University of Medical Sciences,\xa0Hamadan,\xa0Iran.'}, {'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Hosseini', 'Affiliation': 'Department of Pediatrics,\xa0School of Medicine,\xa0Hamadan University of Medical Sciences,\xa0Hamadan,\xa0Iran.'}, {'ForeName': 'Reyhane', 'Initials': 'R', 'LastName': 'Eslamian', 'Affiliation': 'Department of Pediatrics,\xa0School of Medicine,\xa0Hamadan University of Medical Sciences,\xa0Hamadan,\xa0Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Esnaashari', 'Affiliation': 'Department of Community Medicine, School of Medicine, Hamadan University of Medical Sciences, Hamadam, Iran.'}]",Iranian journal of child neurology,['10.22037/ijcn.v15i4.18740']
2564,35222658,Role of Magnesium Supplementation in Children with West Syndrome: A Randomized Controlled Clinical Trial.,"Objectives


West syndrome is a severe epileptic encephalopathy of young age. It is characterized by a clinico-electrical triad of infantile epileptic spasms, regression or arrest of psychomotor development, and hypsarrhythmia. In the last two decades, the large progress in the development of newer antiepileptic drugs has allowed us to have a vast choice of treatment options to control spasms, although they often fail to do so. Thus, there is a need to explore other treatment options.
Materials & Methods


Subjects in this open-labelled randomized control trial were included newly diagnosed children of age between 3 months and 5 years of both genders. A total of 52 children were recruited and randomized into two groups: an intervention group (n=30) and a non-intervention group (n=22). Magnesium sulphate was provided for the intervention group but not for the non-intervention one. Both groups received the rest of the treatments, including adrenocorticotropic hormone and antiepileptic drugs. The follow-up period was three months, at the end of which a per-protocol analysis was performed.
Results


There was no significant difference in seizure control and neurodevelopmental outcome between both groups, but electroencephalogram significantly improved in the intervention group compared to the control. Also, the clinical response was better in patients with normal initial serum magnesium levels in the intervention group (p=0.003) than in other patients.
Conclusion


Magnesium supplementation may be helpful in children with West syndrome.",2022,"There was no significant difference in seizure control and neurodevelopmental outcome between both groups, but electroencephalogram significantly improved in the intervention group compared to the control.","['children with West syndrome', 'newly diagnosed children of age between 3 months and 5 years of both genders', '52 children', 'Children with West Syndrome']","['Magnesium sulphate', 'Magnesium Supplementation', 'Magnesium supplementation', 'adrenocorticotropic hormone and antiepileptic drugs']","['seizure control and neurodevelopmental outcome', 'normal initial serum magnesium levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",52.0,0.0896733,"There was no significant difference in seizure control and neurodevelopmental outcome between both groups, but electroencephalogram significantly improved in the intervention group compared to the control.","[{'ForeName': 'Vijay Kumar', 'Initials': 'VK', 'LastName': 'Yadav', 'Affiliation': 'Department of Pediatrics, M.R.A. Medical College, Ambedkar Nagar, UP, India.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Amrita', 'Affiliation': 'Department of Pediatrics, M.R.A. Medical College, Ambedkar Nagar, UP, India.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Yadav', 'Affiliation': 'Department of Pathology, M.R.A. Medical College, Ambedkarnagar UP India.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Rajeev Kumar, DNB, SR Pediatric Critical Care, Narayana Hrudayalaya, Bengaluru, India.'}, {'ForeName': 'Krishna Kumar', 'Initials': 'KK', 'LastName': 'Yadav', 'Affiliation': 'R.M.L. Institute of Medical Sciences, Lucknow, India.'}]",Iranian journal of child neurology,['10.22037/ijcn.v16i1.30480']
2565,35216603,Impact of the robotic-assistance level on upper extremity function in stroke patients receiving adjunct robotic rehabilitation: sub-analysis of a randomized clinical trial.,"BACKGROUND


Robotic therapy has been demonstrated to be effective in treating upper extremity (UE) paresis in stroke survivors. However, it remains unclear whether the level of assistance provided by robotics in UE training could affect the improvement in UE function in stroke survivors. We aimed to exploratorily investigate the impact of robotic assistance level and modes of adjustment on functional improvement in a stroke-affected UE.
METHODS


We analyzed the data of 30 subacute stroke survivors with mild-to-severe UE hemiplegia who were randomly assigned to the robotic therapy (using ReoGo System) group in our previous randomized clinical trial. A cluster analysis based on the training results (the percentage of each stroke patient's five assistance modes of robotics used during the training) was performed. The patients were divided into two groups: high and low robotic assistance groups. Additionally, the two groups were sub-categorized into the following classes based on the severity of UE functional impairment: moderate-to-mild [Fugl-Meyer Assessment (FMA) score ≥ 30] and severe-to-moderate class (FMA < 30). The outcomes were assessed using FMA, FMA-proximal, performance-time in the Wolf motor function test (WMFT), and functional assessment scale (FAS) in WMFT. The outcomes of each class in the two groups were analyzed. A two-way analysis of variance (ANOVA) was conducted with robot assistance level and severity of UE function as explanatory factors and the change in each outcome pre- and post-intervention as the objective factor.
RESULTS


Overall, significant differences of the group × severity interaction were found in most of the outcomes, including FMA-proximal (p = 0.038, η 2  = 0.13), WMFT-PT (p = 0.021, η 2  = 0.17), and WMFT-FAS (p = 0.045, η 2  = 0.14). However, only the FMA score appeared not to be significantly different in each group (p = 0.103, η 2  = 0.09).
CONCLUSION


An optimal amount of robotic assistance is a key to maximize improvement in post-stroke UE paralysis. Furthermore, severity of UE paralysis is an important consideration when deciding the amount of assistance in robotic therapy. Trial registration Trial enrollment was done at UMIN (UMIN 000001619, registration date was January 1, 2009).",2022,"However, only the FMA score appeared not to be significantly different in each group (p = 0.103, η 2  = 0.09).
","['stroke patients receiving adjunct robotic rehabilitation', '30 subacute stroke survivors with mild-to-severe UE hemiplegia', 'two groups were sub-categorized into the following classes based on the severity of UE functional impairment: moderate-to-mild [Fugl-Meyer Assessment (FMA) score\u2009≥\u200930] and severe-to-moderate class (FMA\u2009<\u200930']","['robotic therapy (using ReoGo System', 'robotic-assistance level']","['FMA, FMA-proximal, performance-time in the Wolf motor function test (WMFT), and functional assessment scale (FAS) in WMFT', 'FMA-proximal', 'WMFT-FAS', 'FMA score', 'UE function']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0327551,"However, only the FMA score appeared not to be significantly different in each group (p = 0.103, η 2  = 0.09).
","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Takebayashi', 'Affiliation': 'Department of Occupational Therapy, School of Comprehensive Rehabilitation, College of Health and Human Sciences, Osaka Prefecture University, 3-7-30, Habikino, Osaka, 583-8555, Japan. takshi77@rehab.osakafu-u.ac.jp.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Occupational Therapy, School of Allied Health Science, Kitasato University, Kanagawa, Japan.'}, {'ForeName': 'Yuho', 'Initials': 'Y', 'LastName': 'Okita', 'Affiliation': 'Faculty of Health, Arts and Design, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Kubo', 'Affiliation': 'Department of Medical Science, Teijin Parma Limited, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Hachisuka', 'Affiliation': 'Moji Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Hyogo, Japan.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-022-00986-9']
2566,35216581,"Effects of veverimer on serum bicarbonate and physical function in women with chronic kidney disease and metabolic acidosis: a subgroup analysis from a randomised, controlled trial.","BACKGROUND


Globally, the prevalence of chronic kidney disease (CKD) is higher in women than in men; however, women have been historically under-represented in nephrology clinical trials. Metabolic acidosis increases risk of progressive loss of kidney function, causes bone demineralization and muscle protein catabolism, and may be more consequential in women given their lower bone and muscle mass. Veverimer, an investigational, non-absorbed polymer that binds and removes gastrointestinal hydrochloric acid, is being developed as treatment for metabolic acidosis.
METHODS


This was a Phase 3, multicenter, randomised, blinded, placebo-controlled trial in 196 patients with CKD (eGFR: 20-40 mL/min/1.73 m 2 ) and metabolic acidosis who were treated for up to 1 year with veverimer or placebo. We present the findings from a pre-specified subgroup analysis evaluating the effects of veverimer on metabolic acidosis and physical function among women (N = 77) enrolled in this trial.
RESULTS


At week 52, women treated with veverimer had a greater increase in mean (± standard error) serum bicarbonate than the placebo group (5.4 [0.5] vs. 2.2 [0.6] mmol/L; P < 0.0001). Physical Function reported by patients on the Kidney Disease and Quality of Life - Physical Function Domain, a measure that includes items related to walking, stair climbing, carrying groceries and other activities improved significantly in women randomized to veverimer vs placebo (+ 13.2 vs. -5.2, respectively, P < 0.0031). Objectively measured performance time on the repeated chair stand test also improved significantly in the veverimer group vs. placebo (P = 0.0002).
CONCLUSIONS


Veverimer was effective in treating metabolic acidosis in women with CKD, and significantly improved how they felt and functioned.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03390842 . Registered on January 4, 2018.",2022,"Objectively measured performance time on the repeated chair stand test also improved significantly in the veverimer group vs. placebo (P = 0.0002).
","['women with CKD', '196 patients with CKD (eGFR: 20-40\u2009mL/min/1.73\u2009m 2 ) and metabolic acidosis who were treated for up to 1\u2009year with veverimer or', 'women than in men', 'women with chronic kidney disease and metabolic acidosis', 'women (N\u2009=\u200977) enrolled in this trial']","['veverimer', 'placebo']","['Kidney Disease and Quality of Life - Physical Function Domain', 'performance time', 'mean (± standard error) serum bicarbonate', 'metabolic acidosis', 'metabolic acidosis and physical function', 'serum bicarbonate and physical function', 'walking, stair climbing, carrying groceries and other activities']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5198161', 'cui_str': 'veverimer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C5198161', 'cui_str': 'veverimer'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",196.0,0.185502,"Objectively measured performance time on the repeated chair stand test also improved significantly in the veverimer group vs. placebo (P = 0.0002).
","[{'ForeName': 'Vandana S', 'Initials': 'VS', 'LastName': 'Mathur', 'Affiliation': 'MathurConsulting LLC, 25 Upenuf Road, Suite 100, Woodside, CA, 94062-2633, USA. md@mathurconsulting.com.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Wesson', 'Affiliation': 'Texas A&M Health Sciences Center College of Medicine, Dallas, TX, USA.'}, {'ForeName': 'Navdeep', 'Initials': 'N', 'LastName': 'Tangri', 'Affiliation': 'University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': 'Pharmastat LLC, Fremont, CA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Bushinsky', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}]",BMC nephrology,['10.1186/s12882-022-02690-1']
2567,35216571,"Deep-learning model for predicting the survival of rectal adenocarcinoma patients based on a surveillance, epidemiology, and end results analysis.","BACKGROUND


We collected information on patients with rectal adenocarcinoma in the United States from the Surveillance, Epidemiology, and EndResults (SEER) database. We used this information to establish a model that combined deep learning with a multilayer neural network (the DeepSurv model) for predicting the survival rate of patients with rectal adenocarcinoma.
METHODS


We collected patients with rectal adenocarcinoma in the United States and older than 20 yearswho had been added to the SEER database from 2004 to 2015. We divided these patients into training and test cohortsat a ratio of 7:3. The training cohort was used to develop a seven-layer neural network based on the analysis method established by Katzman and colleagues to construct a DeepSurv prediction model. We then used the C-index and calibration plots to evaluate the prediction performance of the DeepSurv model.
RESULTS


The 49,275 patients with rectal adenocarcinoma included in the study were randomly divided into the training cohort (70%, n = 34,492) and the test cohort (30%, n = 14,783). There were no statistically significant differences in clinical characteristics between the two cohorts (p > 0.05). We applied Cox proportional-hazards regression to the data in the training cohort, which showed that age, sex, marital status, tumor grade, surgery status, and chemotherapy status were significant factors influencing survival (p < 0.05). Using the training cohort to construct the DeepSurv model resulted in a C-index of the model of 0.824, while using the test cohort to verify the DeepSurv model yielded a C-index of 0.821. Thesevalues show that the prediction effect of the DeepSurv model for the test-cohort patients was highly consistent with the prediction resultsfor the training-cohort patients.
CONCLUSION


The DeepSurv prediction model of the seven-layer neural network that we have established can accurately predict the survival rateand time of rectal adenocarcinoma patients.",2022,There were no statistically significant differences in clinical characteristics between the two cohorts (p > 0.05).,"['49,275 patients with rectal adenocarcinoma', 'patients with rectal adenocarcinoma', 'patients with rectal adenocarcinoma in the United States from the Surveillance, Epidemiology, and EndResults (SEER) database', 'We collected patients with rectal adenocarcinoma in the United States and older than 20 yearswho had been added to the SEER database from 2004 to 2015', 'rectal adenocarcinoma patients']",['Deep-learning model'],"['survival rate', 'clinical characteristics', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",49275.0,0.0248652,There were no statistically significant differences in clinical characteristics between the two cohorts (p > 0.05).,"[{'ForeName': 'Haohui', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Research, The First Affiliated Hospital of Jinan University, Guangzhou, 510630, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Clinical Research, The First Affiliated Hospital of Jinan University, Guangzhou, 510630, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'Department of Clinical Research, The First Affiliated Hospital of Jinan University, Guangzhou, 510630, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': 'Department of Clinical Research, The First Affiliated Hospital of Jinan University, Guangzhou, 510630, China. lyujun2020@jnu.edu.cn.'}]",BMC cancer,['10.1186/s12885-022-09217-9']
2568,35217280,Randomized trial of topical ascorbic acid in DMSO versus imiquimod for the treatment of basal cell carcinoma.,"Skin cancer is the most common cancer in the United States and among Caucasians worldwide, with more people diagnosed each year than all other cancers combined. Basal cell cancer is the most common form with an estimated 4.3 million cases diagnosed annually, and treatment costs estimated at $4.8 billion. The objective of this study was to compare efficacy of a topical solution consisting of 30% ascorbic acid in 95% dimethylsulfoxide with topical imiquimod in the treatment of basal cell carcinoma. Twenty-five patients with 29 biopsy confirmed basal cell carcinomas were randomly assigned to receive either the topically applied ascorbic acid treatment twice daily for 8 weeks or topical imiquimod, a standard and well characterized topical treatment. After 8 weeks, post-treatment biopsy of lesions showed complete resolution of 13/15 (86.7%) in the ascorbic acid group, while 8/14 (57.1%) lesions in the IMQ group were resolved (p < 0.05 Chi Square). Topical ascorbic acid was superior at 8 weeks, and non-inferior at 12 weeks to topical imiquimod in the treatment of low risk nodular and superficial lesions. In addition, ascorbic acid was associated with fewer adverse effects than imiquimod. 70% of patients in the imiquinod group showed residual hypopigmentation at 30mo follow up versus 0% in the ascorbate group.",2022,"Topical ascorbic acid was superior at 8 weeks, and non-inferior at 12 weeks to topical imiquimod in the treatment of low risk nodular and superficial lesions.","['low risk nodular and superficial lesions', 'basal cell carcinoma', 'Twenty-five patients with 29 biopsy confirmed basal cell carcinomas']","['Topical ascorbic acid', 'topical solution consisting of 30% ascorbic acid', 'imiquimod', 'topical ascorbic acid', 'ascorbic acid', 'ascorbic acid treatment twice daily for 8 weeks or topical imiquimod, a standard and well characterized topical treatment', 'dimethylsulfoxide with topical imiquimod', 'topical imiquimod']","['complete resolution', 'Basal cell cancer', 'residual hypopigmentation', 'adverse effects']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0205297', 'cui_str': 'Nodular'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0991555', 'cui_str': 'Cutaneous solution'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0012403', 'cui_str': 'Dimethyl Sulfoxide'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0751676', 'cui_str': 'Basal Cell Cancer'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0162835', 'cui_str': 'Hypopigmentation'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",25.0,0.12594,"Topical ascorbic acid was superior at 8 weeks, and non-inferior at 12 weeks to topical imiquimod in the treatment of low risk nodular and superficial lesions.","[{'ForeName': 'Briant', 'Initials': 'B', 'LastName': 'Burke', 'Affiliation': 'Center for Biomedical Research, Inc., Boise, ID 83706, USA. Electronic address: bburkemd2@gmail.com.'}, {'ForeName': 'Jon-Eric', 'Initials': 'JE', 'LastName': 'Bailie', 'Affiliation': 'Center for Biomedical Research, Inc., Boise, ID 83706, USA.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2022.112710']
2569,35217746,The influence of professional oral hygiene care on reducing ventilator-associated pneumonia in trauma intensive care unit patients.,"Aim This study aimed to examine the effects of professional oral hygiene care for the prevention of ventilator-associated pneumonia (VAP) and the improvement of oral hygiene among patients in the trauma intensive care unit (TICU).Materials and methods TICU patients who underwent intubation were randomly assigned to either the experimental group (n = 29) or control group (n = 28). The developed professional oral hygiene care protocol was administered to patients in the experimental group every 24 hours. Additionally, data regarding general characteristics, medical history, oral hygiene status, Clinical Pulmonary Infection Score and quantitative polymerase chain reaction were assessed.Results The incidence of VAP differed between the control group (10.58) and experimental group (0) post intervention. Post-admission bedside oral exam scores with significant differences in oral hygiene were observed in the experimental group (in contrast to the control group) from 48 hours onwards (10.69 ± 3.43, p = 0.06). Staphylococcus aureus and Klebsiella pneumoniae exhibited significant differences in count as professional oral hygiene care continued.Conclusions This study suggests a model in which different health care professionals can cooperate to reduce the incidence of VAP and improve oral health conditions.",2022,"Post-admission bedside oral exam scores with significant differences in oral hygiene were observed in the experimental group (in contrast to the control group) from 48 hours onwards (10.69 ± 3.43, p = 0.06).","['patients in the trauma intensive care unit (TICU).Materials and methods TICU patients who underwent intubation', 'trauma intensive care unit patients']",['professional oral hygiene care'],"['incidence of VAP', 'general characteristics, medical history, oral hygiene status, Clinical Pulmonary Infection Score and quantitative polymerase chain reaction', 'oral hygiene']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4047661', 'cui_str': 'Trauma intensive care unit'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C4082459', 'cui_str': 'Oral hygiene status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}]",,0.0504113,"Post-admission bedside oral exam scores with significant differences in oral hygiene were observed in the experimental group (in contrast to the control group) from 48 hours onwards (10.69 ± 3.43, p = 0.06).","[{'ForeName': 'Ma-I', 'Initials': 'MI', 'LastName': 'Choi', 'Affiliation': 'Department of Dental Hygiene, College of Software and Digital Healthcare Convergence, Yonsei University, Republic Of Korea.'}, {'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Han', 'Affiliation': 'Department of Dental Hygiene, College of Software and Digital Healthcare Convergence, Yonsei University, Republic Of Korea.'}, {'ForeName': 'Hyun-Sun', 'Initials': 'HS', 'LastName': 'Jeon', 'Affiliation': 'Department of Dental Hygiene, Yeoju Institute of Technology, Republic Of Korea.'}, {'ForeName': 'Eun-Sil', 'Initials': 'ES', 'LastName': 'Choi', 'Affiliation': 'Department of Dental Hygiene, The Graduate School, Yonsei University, Republic Of Korea.'}, {'ForeName': 'Seung-Eun', 'Initials': 'SE', 'LastName': 'Won', 'Affiliation': 'Dental Life Science Research Institute, The Seoul National University Dental Hospital, Republic Of Korea.'}, {'ForeName': 'Ye-Ji', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Dental Hygiene, NYU College of Dentistry, New York, USA.'}, {'ForeName': 'Ji-Hye', 'Initials': 'JH', 'LastName': 'Yang', 'Affiliation': 'Department of Oral Pathology, Yonsei University College of Dentistry, Republic Of Korea.'}, {'ForeName': 'Chi-Yun', 'Initials': 'CY', 'LastName': 'Baek', 'Affiliation': 'Department of Nursing, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Republic Of Korea.'}, {'ForeName': 'Hongjin', 'Initials': 'H', 'LastName': 'Shim', 'Affiliation': 'Regional Trauma Centre, Department of Surgery, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Republic Of Korea.'}, {'ForeName': 'So-Jung', 'Initials': 'SJ', 'LastName': 'Mun', 'Affiliation': 'Department of Dental Hygiene, Yeoju Institute of Technology, Republic Of Korea. sojung77@yonsei.ac.kr.'}]",British dental journal,['10.1038/s41415-022-3986-3']
2570,35217662,Deep rTMS of the insula and prefrontal cortex in smokers with schizophrenia: Proof-of-concept study.,"Patients with schizophrenia have a high prevalence of cigarette smoking and respond poorly to conventional treatments, highlighting the need for new therapies. We conducted a mechanistic, proof-of-concept study using bilateral deep repetitive transcranial magnetic stimulation (dTMS) of insular and prefrontal cortices at high frequency, using the specialized H4 coil. Feasibility of dTMS was tested for disruption of tobacco self-administration, insula target engagement, and insula circuit modulation, all of which were a priori outcomes of interest. Twenty patients completed the study, consisting of weekday dTMS sessions (randomization to active dTMS or sham; double-blind; 10 patients per group), a laboratory tobacco self-administration paradigm (pre/post assessments), and multimodal imaging (three MRI total sessions). Results showed that participants assigned to active dTMS were slower to initiate smoking their first cigarette compared with sham, consistent with smoking disruption. The imaging analyses did not reveal significant Time × Group interactions, but effects were in the anticipated directions. In arterial spin labeling analyses testing for target engagement, an overall decrease in insula blood flow, measured during a post-treatment MRI versus baseline, was numerically more pronounced in the active dTMS group than sham. In fMRI analyses, resting-state connectivity between the insula and default mode network showed a numerically greater change from baseline in the active dTMS group than sham, consistent with a functional change to insula circuits. Exploratory analyses further suggested a therapeutic effect of dTMS on symptoms of psychosis. These initial observations pave the way for future confirmatory studies of dTMS in smoking patients with schizophrenia.",2022,"In fMRI analyses, resting-state connectivity between the insula and default mode network showed a numerically greater change from baseline in the active dTMS group than sham, consistent with a functional change to insula circuits.","['smokers with schizophrenia', 'smoking patients with schizophrenia', 'Patients with schizophrenia', 'Twenty patients completed the study, consisting of']","['weekday dTMS sessions (randomization to active dTMS or sham; double-blind; 10 patients per group), a laboratory tobacco self-administration paradigm (pre/post assessments), and multimodal imaging (three MRI total sessions', 'dTMS', 'bilateral deep repetitive transcranial magnetic stimulation (dTMS']","['insula blood flow', 'resting-state connectivity']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1513743', 'cui_str': 'Imaging, Multimodal'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]",20.0,0.102349,"In fMRI analyses, resting-state connectivity between the insula and default mode network showed a numerically greater change from baseline in the active dTMS group than sham, consistent with a functional change to insula circuits.","[{'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Moeller', 'Affiliation': 'Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, 11794, USA. scott.moeller@stonybrookmedicine.edu.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Gil', 'Affiliation': 'Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Jodi J', 'Initials': 'JJ', 'LastName': 'Weinstein', 'Affiliation': 'Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Topaz', 'Initials': 'T', 'LastName': 'Baumvoll', 'Affiliation': 'Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Wengler', 'Affiliation': 'Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Natalka', 'Initials': 'N', 'LastName': 'Fallon', 'Affiliation': 'Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Jared X', 'Initials': 'JX', 'LastName': 'Van Snellenberg', 'Affiliation': 'Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Abeykoon', 'Affiliation': 'Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Perlman', 'Affiliation': 'Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Lucian', 'Initials': 'L', 'LastName': 'Manu', 'Affiliation': 'Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Slifstein', 'Affiliation': 'Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'Clifford M', 'Initials': 'CM', 'LastName': 'Cassidy', 'Affiliation': 'University of Ottawa Institute of Mental Health Research, affiliated with The Royal, Ottawa, ON, K1Z 8N3, Canada.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Martinez', 'Affiliation': 'Columbia University, New York State Psychiatric Institute, New York, NY, 10032, USA.'}, {'ForeName': 'Anissa', 'Initials': 'A', 'LastName': 'Abi-Dargham', 'Affiliation': 'Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, 11794, USA. anissa.abi-dargham@stonybrookmedicine.edu.'}]",NPJ schizophrenia,['10.1038/s41537-022-00224-0']
2571,35217575,Phase I/II study of the LAG-3 inhibitor ieramilimab (LAG525) ± anti-PD-1 spartalizumab (PDR001) in patients with advanced malignancies.,"BACKGROUND


Lymphocyte-activation gene 3 (LAG-3) is an inhibitory immunoreceptor that negatively regulates T-cell activation. This paper presents preclinical characterization of the LAG-3 inhibitor, ieramilimab (LAG525), and phase I data for the treatment of patients with advanced/metastatic solid tumors with ieramilimab ±the anti-programmed cell death-1 antibody, spartalizumab.
METHODS


Eligible patients had advanced/metastatic solid tumors and progressed after, or were unsuitable for, standard-of-care therapy, including checkpoint inhibitors in some cases. Patients received ieramilimab ±spartalizumab across various dose-escalation schedules. The primary objective was to assess the maximum tolerated dose (MTD) or recommended phase II dose (RP2D).
RESULTS


In total, 255 patients were allocated to single-agent ieramilimab (n=134) and combination (n=121) treatment arms. The majority (98%) had received prior antineoplastic therapy (median, 3). Four patients experienced dose-limiting toxicities in each treatment arm across various dosing cohorts. No MTD was reached. The RP2D on a 3-week schedule was declared as 400 mg ieramilimab plus 300 mg spartalizumab and, on a 4-week schedule (once every 4 weeks; Q4W), as 800 mg ieramilimab plus 400 mg spartalizumab; tumor target (LAG-3) suppression with 600 mg ieramilimab Q4W was predicted to be similar to the Q4W, RP2D schedule. Treatment-related adverse events (TRAEs) occurred in 75 (56%) and 84 (69%) patients in the single-agent and combination arms, respectively. Most common TRAEs were fatigue, gastrointestinal, and skin disorders, and were of mild severity; seven patients experienced at least one treatment-related serious adverse event in the single-agent (5%) and combination group (5.8%). Antitumor activity was observed in the combination arm, with 3 (2%) complete responses and 10 (8%) partial responses in a mixed population of tumor types. In the combination arm, eight patients (6.6%) experienced stable disease for 6 months or longer versus six patients (4.5%) in the single-agent arm. Responding patients trended towards having higher levels of immune gene expression, including  CD8  and  LAG3 , in tumor tissue at baseline.
CONCLUSIONS


Ieramilimab was well tolerated as monotherapy and in combination with spartalizumab. The toxicity profile of ieramilimab in combination with spartalizumab was comparable to that of spartalizumab alone. Modest antitumor activity was seen with combination treatment.
TRIAL REGISTRATION NUMBER


NCT02460224.",2022,"Responding patients trended towards having higher levels of immune gene expression, including  CD8  and  LAG3 , in tumor tissue at baseline.
","['Eligible patients had advanced/metastatic solid tumors and progressed after, or were unsuitable for, standard-of-care therapy, including checkpoint inhibitors in some cases', '255 patients', 'patients with advanced malignancies', 'patients with advanced/metastatic solid tumors with ieramilimab ±the anti-programmed cell death-1 antibody, spartalizumab']","['ieramilimab plus 400\u2009mg spartalizumab; tumor target (LAG-3) suppression with 600\u2009mg ieramilimab Q4W', 'LAG-3 inhibitor ieramilimab (LAG525) ± anti-PD-1 spartalizumab (PDR001', 'single-agent ieramilimab', 'antineoplastic therapy', 'ieramilimab ±spartalizumab']","['immune gene expression, including  CD8  and  LAG3 , in tumor tissue', 'fatigue, gastrointestinal, and skin disorders', 'adverse events (TRAEs', 'dose-limiting toxicities', 'Antitumor activity', 'maximum tolerated dose (MTD) or recommended phase II dose (RP2D', 'Modest antitumor activity', 'toxicity profile of ieramilimab', 'stable disease']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0024262', 'cui_str': 'Blast Transformation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C1456336', 'cui_str': 'lymphocyte-activation gene 3 protein, human'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",255.0,0.0471161,"Responding patients trended towards having higher levels of immune gene expression, including  CD8  and  LAG3 , in tumor tissue at baseline.
","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'Department of General Medical Oncology, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Daniel S W', 'Initials': 'DSW', 'LastName': 'Tan', 'Affiliation': 'National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martín', 'Affiliation': 'Hospital General Universitario Gregorio Maranon, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Ochoa-de-Olza', 'Affiliation': ""Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sarantopoulos', 'Affiliation': 'Institute for Drug Development, Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cancer Center, San Antonio, Texas, USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Carvajal', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Chrisann', 'Initials': 'C', 'LastName': 'Kyi', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Taito', 'Initials': 'T', 'LastName': 'Esaki', 'Affiliation': 'National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Prawira', 'Affiliation': 'Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Wallace', 'Initials': 'W', 'LastName': 'Akerley', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'De Braud', 'Affiliation': 'Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': 'Westmead Hospital and The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Soo', 'Affiliation': 'National University Cancer Institute, Singapore.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Maur', 'Affiliation': 'Oncologia Medica, AOU Policlinico di Modena, Modena, Emilia-Romagna, Italy.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Weickhardt', 'Affiliation': 'Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Krauss', 'Affiliation': 'National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Deschler-Baier', 'Affiliation': 'Universitätsklinikum Würzburg, Wurzburg, Germany.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Lau', 'Affiliation': 'Novartis Institutes for BioMedical Research Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Tanay S', 'Initials': 'TS', 'LastName': 'Samant', 'Affiliation': 'Novartis Institutes for BioMedical Research Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Longmire', 'Affiliation': 'Novartis Institutes for BioMedical Research Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Niladri Roy', 'Initials': 'NR', 'LastName': 'Chowdhury', 'Affiliation': 'Novartis Institutes for BioMedical Research Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sabatos-Peyton', 'Affiliation': 'Novartis Institutes for BioMedical Research Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Novartis Institutes for BioMedical Research Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Ramesh', 'Affiliation': 'Novartis Institutes for BioMedical Research Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Tiancen', 'Initials': 'T', 'LastName': 'Hu', 'Affiliation': 'Novartis Institutes for BioMedical Research Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Carion', 'Affiliation': 'Novartis Institutes for BioMedical Research Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gusenleitner', 'Affiliation': 'Novartis Institutes for BioMedical Research Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Padmaja', 'Initials': 'P', 'LastName': 'Yerramilli-Rao', 'Affiliation': 'Novartis Institutes for BioMedical Research Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Askoxylakis', 'Affiliation': 'Novartis Institutes for BioMedical Research Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Eunice L', 'Initials': 'EL', 'LastName': 'Kwak', 'Affiliation': 'Novartis Institutes for BioMedical Research Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Hong', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas, USA dshong@mdanderson.org.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2021-003776']
2572,35218628,[Clinical research of Pinggan Jiangya decoction combined with penetrating needling at Baihui (GV20) in a period of day from 7 am to 9 am in the treatment of grade 1 and 2 essential hypertension].,"OBJECTIVE


To explore the clinical effect of Pinggan Jiangya decoction combined with penetrating needling at Baihui (GV20) in a period of day from 7 am to 9 am in the treatment of grade 1 and 2 essential hypertension (EH).
METHODS


A total of 150 cases of grade 1 and 2 EH patients were randomized into an observation group and a control group, 75 cases in each group. In the control group, Pinggan Jiangya decoction was prescribed for oral administration one dose a day, while in the observation group, on the basis of the treatment as the control group, penetrating needling was exerted at GV20 once daily. The treatment duration was 8 weeks. Before and after treatment, the TCM syndrome score, 24 h average systolic blood pressure (24 h ASBP), 24 h average diastolic blood pressure (24 h ADBP), 24 h average pulse pressure difference (24 h PP), morning blood pressure surge (MBPS), 24 h SBP variability (24 h SBPV), 24 h DBP variability (24 h DBPV), serum levels of 5-hydroxytryptamine (5-HT) and melatonin (MT) were compared in the patients of the two groups. The clinical therapeutic effect was observed in the two groups.
RESULTS


After the treatment, in the self-comparison of each group, the scores of headache, vertigo, backache, soft knees, tinnitus, 24 h ASBP， 24 h ADBP, 24 h PP, MBPS, 24 h SBPV and 24 h DBPV in the two groups were lower than those before treatment ( P <0.01), and the above indexes in the observation group were lower than those in the control group ( P <0.01). The level of serum 5-HT after the treatment was lower than that of before the treatment ( P <0.01), while the level of MT was higher than that of before the treatment ( P <0.01) in both two groups, and the level of 5-HT in the observation group was lower than that of the control group, while the level of MT was higher than that of the control group ( P <0.01). The total effective rate of the observation group was 93.3% (70/75), better than 76.0% (57/75) of the control group ( P <0.01).
CONCLUSION


Pinggan Jiangya decoction combined with penetrating needling at GV20 in a period of day from 7 am to 9 am can regulate the levels of serum MT and 5-HT, effectively reduce blood pressure, improve blood pressure variability, control morning peak blood pressure, and has a remarkable effect in the treatment of grade 1 and 2 EH.",2022,"The level of serum 5-HT after the treatment was lower than that of before the treatment ( P <0.01), while the level of MT was higher than that of before the treatment ( P <0.01) in both two groups, and the level of 5-HT in the observation group was lower than that of the control group, while the level of MT was higher than that of the control group ( P <0.01).","['A total of 150 cases of grade 1 and 2 EH patients', 'grade 1 and 2 essential hypertension (EH']","['Pinggan Jiangya decoction combined with penetrating needling at Baihui (GV20', 'Pinggan Jiangya decoction combined with penetrating needling at GV20', 'Pinggan Jiangya decoction']","['level of serum 5-HT', 'total effective rate', 'level of MT', 'average diastolic blood pressure (24 h ADBP), 24 h average pulse pressure difference (24 h PP), morning blood pressure surge (MBPS), 24 h SBP variability (24 h SBPV), 24 h DBP variability (24 h DBPV), serum levels of 5-hydroxytryptamine (5-HT) and melatonin (MT', 'clinical therapeutic effect', 'level of 5-HT', 'blood pressure, improve blood pressure variability, control morning peak blood pressure', 'TCM syndrome score, 24 h average systolic blood pressure', 'scores of headache, vertigo, backache, soft knees, tinnitus, 24 h ASBP， 24 h ADBP, 24 h PP, MBPS, 24 h SBPV and 24 h DBPV']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0450800', 'cui_str': 'GV20'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1282163', 'cui_str': 'Average diastolic blood pressure'}, {'cui': 'C0168370', 'cui_str': 'adipoylbisphosphonic acid'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}]",150.0,0.0307992,"The level of serum 5-HT after the treatment was lower than that of before the treatment ( P <0.01), while the level of MT was higher than that of before the treatment ( P <0.01) in both two groups, and the level of 5-HT in the observation group was lower than that of the control group, while the level of MT was higher than that of the control group ( P <0.01).","[{'ForeName': 'Xiao-Ling', 'Initials': 'XL', 'LastName': 'Zhou', 'Affiliation': ""The People's Hospital of Longhua District, Shenzhen 518110, Guangdong Province, China.""}, {'ForeName': 'Yan-Hua', 'Initials': 'YH', 'LastName': 'Du', 'Affiliation': ""The People's Hospital of Longhua District, Shenzhen 518110, Guangdong Province, China.""}, {'ForeName': 'Xiao-Hui', 'Initials': 'XH', 'LastName': 'Chen', 'Affiliation': ""The People's Hospital of Longhua District, Shenzhen 518110, Guangdong Province, China.""}, {'ForeName': 'Wen-Ying', 'Initials': 'WY', 'LastName': 'Liu', 'Affiliation': ""The People's Hospital of Longhua District, Shenzhen 518110, Guangdong Province, China.""}, {'ForeName': 'Yu-Mei', 'Initials': 'YM', 'LastName': 'Huang', 'Affiliation': ""The People's Hospital of Longhua District, Shenzhen 518110, Guangdong Province, China.""}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.201094']
2573,35218627,[Core stability training combined with acupuncture in treatment of chronic nonspecific low back pain: a prospective randomized controlled trial].,"OBJECTIVE


To investigate the clinical effect of core stability training combined with acupuncture in the treatment of chronic nonspecific low back pain (CLBP).
METHODS


Seventy-five CLBP patients were randomly divided into experimental group ( n =38) and control group ( n =37) according to a random number table. Patients in the control group were required to perform core stability training, whereas those in the experimental group received core stability training combined with fire needle acupuncture, once every two days, three times per week, for four successive weeks. The Oswestry disability index (ODI), visual analogue scale (VAS), lumbar muscular endurance index, clinical efficacy, as well as average electromyographic (AEMG), root mean square (RMS), median frequency (MF), and average median frequency (AMF) values during multifidus muscle contraction in the two groups before and after the treatment were compared.
RESULTS


After treatment, ODI, VAS, MF, and AMF of the two groups were lower than those before the treatment ( P <0.01), while the lumbar static and dynamic muscular endurance, AEMG, and RMS values were higher ( P <0.01). The ODI, VAS, MF, and AMF of the experimental group significantly declined as compared with those of the control group ( P <0.01), whereas the lumbar static and dynamic muscular endurance, AEMG, and RMS values were elevated ( P <0.01). The total effective rate of the experimental group was 97.14%(34/35), higher than 85.71%(30/35) of the control group( P <0.01).
CONCLUSION


Core stability training combined with acupuncture effectively enhances lumbar muscular endurance, improves electromyographic signals of multifidus muscle and lumbar function, and relieves pain, implying the good efficacy of such combined therapy in treating CLBP.",2022,"After treatment, ODI, VAS, MF, and AMF of the two groups were lower than those before the treatment ( P <0.01), while the lumbar static and dynamic muscular endurance, AEMG, and RMS values were higher ( P <0.01).","['chronic nonspecific low back pain (CLBP', 'Seventy-five CLBP patients', 'chronic nonspecific low back pain']","['acupuncture', 'core stability training combined with fire needle acupuncture', 'core stability training combined with acupuncture', 'Core stability training combined with acupuncture']","['Oswestry disability index (ODI), visual analogue scale (VAS), lumbar muscular endurance index, clinical efficacy, as well as average electromyographic (AEMG), root mean square (RMS), median frequency (MF), and average median frequency (AMF) values during multifidus muscle contraction', 'total effective rate', 'electromyographic signals of multifidus muscle and lumbar function, and relieves pain', 'ODI, VAS, MF, and AMF', 'lumbar muscular endurance', 'lumbar static and dynamic muscular endurance, AEMG, and RMS values']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0181956', 'cui_str': 'Acupuncture needle'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",75.0,0.0191383,"After treatment, ODI, VAS, MF, and AMF of the two groups were lower than those before the treatment ( P <0.01), while the lumbar static and dynamic muscular endurance, AEMG, and RMS values were higher ( P <0.01).","[{'ForeName': 'Shao-Kang', 'Initials': 'SK', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai Pudong New Area Gongli Hospital, Shanghai 200135, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai Pudong New Area Gongli Hospital, Shanghai 200135, China.'}, {'ForeName': 'Xiao-Wen', 'Initials': 'XW', 'LastName': 'Cao', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai Pudong New Area Gongli Hospital, Shanghai 200135, China.'}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai Pudong New Area Gongli Hospital, Shanghai 200135, China.'}, {'ForeName': 'Zhi-Qing', 'Initials': 'ZQ', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai Pudong New Area Gongli Hospital, Shanghai 200135, China.'}, {'ForeName': 'Yuan-Xiao', 'Initials': 'YX', 'LastName': 'Fan', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai Pudong New Area Gongli Hospital, Shanghai 200135, China.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.201050']
2574,35219222,"Effect of the Mindfulness-Based Stress Reduction program on stress, anxiety, and childbirth fear in pregnant women diagnosed with COVID-19.","OBJECTIVE


This study aims to examine the effectiveness of a live online Mindfulness-Based Stress Reduction (MBSR) program in preventing distress, anxiety and childbirth fear in pregnant women diagnosed with COVID-19.
MATERIAL AND METHODS


Designed as a randomized-controlled trial, this study was performed with the participation of pregnant women who were diagnosed with COVID-19. The sample comprised 84 pregnant women, including 42 in the experimental group and 42 in the control group. The online MBSR program composed of eight sessions and lasting four weeks was provided to the pregnant women in the experimental group, whereas such an initiative was not provided to the control group. The data were collected via the Revised Prenatal Distress Questionnaire (NuPDQ), the Beck Anxiety Inventory (BAI), and the Childbirth Attitudes Questionnaire (CAQ).
RESULTS


After the MBSR program, the mean NuPDQ, BAI and CAQ scores of the pregnant women in the experimental group were significantly lower than the mean scores of those in the control group (p < 0.001).
CONCLUSION


The online MBSR program may be utilized to reduce the distress, anxiety and childbirth fear levels of pregnant women diagnosed with COVID-19. By using the MBSR program, health professionals might improve the psychological well-being of pregnant women diagnosed with COVID-19.",2022,"The online MBSR program composed of eight sessions and lasting four weeks was provided to the pregnant women in the experimental group, whereas such an initiative was not provided to the control group.","['84 pregnant women, including 42 in the experimental group and 42 in the control group', 'pregnant women diagnosed with COVID-19', 'pregnant women who were diagnosed with COVID-19']","['Mindfulness-Based Stress Reduction program', 'live online Mindfulness-Based Stress Reduction (MBSR) program']","['distress, anxiety and childbirth fear', 'mean NuPDQ, BAI and CAQ scores', 'Prenatal Distress Questionnaire (NuPDQ), the Beck Anxiety Inventory (BAI), and the Childbirth Attitudes Questionnaire (CAQ', 'distress, anxiety and childbirth fear levels', 'stress, anxiety, and childbirth fear']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",84.0,0.0444026,"The online MBSR program composed of eight sessions and lasting four weeks was provided to the pregnant women in the experimental group, whereas such an initiative was not provided to the control group.","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Güney', 'Affiliation': 'Department of Midwifery, Faculty of Health Sciences, İnönü University, Malatya, Turkey. Electronic address: esra.guney@inonu.edu.tr.'}, {'ForeName': 'Sıdıka Özlem', 'Initials': 'SÖ', 'LastName': 'Cengizhan', 'Affiliation': 'Department of Midwifery, Faculty of Health Sciences, Gaziantep Islam Science and University, Gaziantep, Turkey. Electronic address: sidika_cengizhan@hotmail.com.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Karataş Okyay', 'Affiliation': 'Department of Midwifery, Faculty of Health Sciences, Kahramanmaraş Sütçü İmam University, Kahramanmaraş, Turkey. Electronic address: eokyay@ksu.edu.tr.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Bal', 'Affiliation': 'Department of Midwifery, Faculty of Health Sciences, İnönü University, Malatya, Turkey. Electronic address: zeynepp_ball@hotmail.com.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Uçar', 'Affiliation': 'Department of Midwifery, Faculty of Health Sciences, İnönü University, Malatya, Turkey. Electronic address: tuba.ucar@inonu.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2022.101566']
2575,35219171,Impact of exercise as a complementary management strategy in people with epilepsy: A randomized controlled trial.,"OBJECTIVE


To measure the impact of 12 weeks of physical exercise as complementary management strategy on quality of life (QOL) in people with epilepsy (PWE).
METHODS


In a parallel-group, randomized controlled study with blinded outcome assessment, PWE of 18-65 years old, smartphone users were randomized into two groups. The exercise group was advised minimum 150 min per week of moderate-intense aerobic activity, as per current WHO recommendation [1], in addition to standard medical care; the control group received only standard medical care. QOL was assessed using Quality of Life in Epilepsy (QOLIE-31) inventory [2,3]; physical activity, with Global Physical Activity Questionnaire version 2 (GPAQ), and Pedometer Step Counter (a smartphone-based activity tracker application), at baseline and after 12 weeks. Body weight, body mass index, seizure frequency, and stigma scores (Epilepsy Stigma Scale Austin and colleagues) [4] were also noted.
RESULTS


One hundred and seventeen PWE were recruited (58 exercise, 59 control). Although there was an improvement in the physical activity correlates after 12 weeks compared to mean values at baseline, the differences were not significant between the groups. The total QOL mean scores at baseline in the exercise and control groups were 64.9 and 63.7 (p = 0.597) and after 12 weeks, 68.4 and 66.9 (p = 0.660), respectively. However, intragroup comparison of energy/fatigue score in the exercise group showed significant change with a p value of 0.009 and intragroup comparison of Overall QOL score in the control group showed a significant change with a p value of 0.003. Similar improvement was seen in stigma scores (p = 0.500) and seizure frequency (p = 0.388) at 12 weeks in exercise and control groups. After 12 weeks, mean values of METS ((metabolic equivalents) were 794.81 and 714.27 (p = 0.159), steps per day were 4018.32 and 3730.0 (p = 0.314), calories spent per day were 173.85 and 159.68 (p = 0.320 and distance walked per day in meters were 2576.52 and 2198.42 (p = 0.072), in the exercise and control groups, respectively.
SIGNIFICANCE


Regular physical activity for at least 150 min per week, in the form of moderate-intense aerobic exercises resulted in positive yet non-significant improvement of QOL, seizure frequency, and stigma in PWE.",2022,Similar improvement was seen in stigma scores (p = 0.500) and seizure frequency (p = 0.388) at 12 weeks in exercise and control groups.,"['people with epilepsy', 'people with epilepsy (PWE', 'One hundred and seventeen PWE were recruited (58 exercise, 59 control', '18-65\u202fyears old, smartphone users']","['physical exercise', 'exercise', 'exercise group was advised minimum 150\u202fmin per week of moderate-intense aerobic activity, as per current WHO recommendation [1], in addition to standard medical care; the control group received only standard medical care']","['mean values of METS ((metabolic equivalents', 'QOL, seizure frequency, and stigma in PWE', 'Body weight, body mass index, seizure frequency, and stigma scores (Epilepsy Stigma Scale Austin and colleagues', 'physical activity correlates', 'total QOL mean scores', 'Overall QOL score', 'QOL', 'energy/fatigue score', 'seizure frequency', 'calories spent per day', 'stigma scores', 'Quality of Life in Epilepsy (QOLIE-31) inventory [2,3]; physical activity, with Global Physical Activity Questionnaire version 2 (GPAQ), and Pedometer Step Counter (a smartphone-based activity tracker application', 'quality of life (QOL']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0605411', 'cui_str': 'austin'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",117.0,0.0304374,Similar improvement was seen in stigma scores (p = 0.500) and seizure frequency (p = 0.388) at 12 weeks in exercise and control groups.,"[{'ForeName': 'Mukesh', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Neurology, Neurosciences Centre, All India Institute of Medical Sciences, New Delhi 110 029, India.'}, {'ForeName': 'Bhargavi', 'Initials': 'B', 'LastName': 'Ramanujam', 'Affiliation': 'Department of Neurology, Neurosciences Centre, All India Institute of Medical Sciences, New Delhi 110 029, India.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Barki', 'Affiliation': 'Department of Neurology, Neurosciences Centre, All India Institute of Medical Sciences, New Delhi 110 029, India.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Dwivedi', 'Affiliation': 'Department of Neurology, Neurosciences Centre, All India Institute of Medical Sciences, New Delhi 110 029, India.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Vibha', 'Affiliation': 'Department of Neurology, Neurosciences Centre, All India Institute of Medical Sciences, New Delhi 110 029, India.'}, {'ForeName': 'Rajesh K', 'Initials': 'RK', 'LastName': 'Singh', 'Affiliation': 'Department of Neurology, Neurosciences Centre, All India Institute of Medical Sciences, New Delhi 110 029, India.'}, {'ForeName': 'Manjari', 'Initials': 'M', 'LastName': 'Tripathi', 'Affiliation': 'Department of Neurology, Neurosciences Centre, All India Institute of Medical Sciences, New Delhi 110 029, India. Electronic address: mantriaiims@gmail.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2022.108616']
2576,35219167,Preoperative low-residue diet in gynecological surgery.,"OBJECTIVE


To evaluate the impact of preoperative low-residue diet on intra- and postoperative outcomes among gynecological surgical patients.
METHODS


This is a surgeon-blind, randomized controlled trial enrolling patients undergoing elective surgery for either benign disease or endometrial carcinoma. Patients were preoperatively randomized to receive either low-residue diet (arm A) or free diet (arm B) starting from three days before surgery. The primary outcome was the quality of the surgical field (scored using a 5-point scale, from poor to excellent). Secondary outcomes were postoperative pain (assessed through VAS scale), postoperative complications, operative time, time to first passage of flatus, length of hospital stay. Perioperative data were collected and compared between groups.
RESULTS


A total of 96 patients were enrolled and randomized in arm A (n = 49; 51%) and arm B (n = 47; 49%). The mean age was 47.8 ± 15.6 years in arm A and 48.1 ± 11.3 years in arm B. Endometrial cancer patients were 16.3% in arm A and 10.6% in arm B, and patients with benign disease were 83.7% and 89.4%, respectively. The surgical evaluation of the small intestine was scored < 3 in 2.0% of arm A patients versus 31.9% in arm B (Odds Ratio (OR), 0.04 [95% CI, 0.01-0.35]; p < 0.001), and in 6.1% and 44.7% (OR, 0.08 [95% CI, 0.02-0.30]; p < 0.001), respectively, for large intestine. The mean operative time was 90.4 ± 33.4 min in arm A versus 111.6 ± 37.5 in arm B (Mean Difference (MD): -21.20 [95% CI, -35.43, -6.97]; p = 0.003). The number of patients who reported the time to first flatus within 24 h after surgery was significantly higher in arm A compared with arm B (77.6% vs 44.7%; OR, 4.28 [95% CI, 1.77-10.35]; p = 0.002). No significant differences in terms of postoperative complications, pain, and length of hospital stay were observed between the two groups.
CONCLUSION


Introducing a preoperative low-residue diet could improve the quality of the surgical field and reduce both the operative duration and the time to first passage of flatus among patients undergoing gynecological surgery. Further large-scale studies are required to confirm these findings.",2022,"No significant differences in terms of postoperative complications, pain, and length of hospital stay were observed between the two groups.
","['A total of 96 patients', 'patients undergoing elective surgery for either benign disease or endometrial carcinoma', 'patients undergoing gynecological surgery', 'gynecological surgical patients', 'The mean age was 47.8\xa0±\xa015.6\xa0years in arm A and 48.1\xa0±\xa011.3\xa0years in arm B. Endometrial cancer patients', 'gynecological surgery']","['preoperative low-residue diet', 'Preoperative low-residue diet', 'low-residue diet (arm A) or free diet']","['time to first flatus', 'postoperative pain (assessed through VAS scale), postoperative complications, operative time, time to first passage of flatus, length of hospital stay', 'quality of the surgical field (scored using a 5-point scale, from poor to excellent', 'benign disease', 'postoperative complications, pain, and length of hospital stay', 'mean operative time']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0476089', 'cui_str': 'Endometrial carcinoma'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0425404', 'cui_str': 'Low residue diet'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",96.0,0.244578,"No significant differences in terms of postoperative complications, pain, and length of hospital stay were observed between the two groups.
","[{'ForeName': 'Innocenza', 'Initials': 'I', 'LastName': 'Palaia', 'Affiliation': 'Department of Maternal and Child Health and Urological Sciences, Sapienza University, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Violante', 'Initials': 'V', 'LastName': 'Di Donato', 'Affiliation': 'Department of Maternal and Child Health and Urological Sciences, Sapienza University, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Caruso', 'Affiliation': 'Department of Maternal and Child Health and Urological Sciences, Sapienza University, Policlinico Umberto I, Rome, Italy. Electronic address: g.caruso@uniroma1.it.'}, {'ForeName': 'Annarita', 'Initials': 'A', 'LastName': 'Vestri', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Scudo', 'Affiliation': 'Department of Maternal and Child Health and Urological Sciences, Sapienza University, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Alunni Fegatelli', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Galli', 'Affiliation': 'Department of Maternal and Child Health and Urological Sciences, Sapienza University, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Cavalli', 'Affiliation': 'Department of Maternal and Child Health and Urological Sciences, Sapienza University, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Perniola', 'Affiliation': 'Department of Maternal and Child Health and Urological Sciences, Sapienza University, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Benedetti Panici', 'Affiliation': 'Department of Maternal and Child Health and Urological Sciences, Sapienza University, Policlinico Umberto I, Rome, Italy.'}, {'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Muzii', 'Affiliation': 'Department of Maternal and Child Health and Urological Sciences, Sapienza University, Policlinico Umberto I, Rome, Italy.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2022.02.018']
2577,35219331,The effect of empagliflozin on growth differentiation factor 15 in patients with heart failure: a randomized controlled trial (Empire HF Biomarker).,"BACKGROUND


Plasma growth differentiation factor-15 (GDF-15) biomarker levels increase in response to inflammation and tissue injury, and increased levels of GDF-15 are associated with increased risk of mortality in patients with heart failure with reduced ejection fraction (HFrEF). Sodium-glucose cotransporter-2 (SGLT2) inhibitors, which improve outcome in HFrEF, have been shown to increase plasma GDF-15 in diabetic patients. We aimed to investigate the effect of empagliflozin on GDF-15 in HFrEF patients.
METHODS


This Empire HF Biomarker substudy was from the multicentre, randomized, double-blind, placebo-controlled Empire HF trial that included 190 patients from June 29, 2017, to September 10, 2019. Stable ambulatory HFrEF patients with ejection fraction of ≤ 40% were randomly assigned (1:1) to empagliflozin 10 mg once daily, or matching placebo for 12 weeks. Changes from baseline to 12 weeks in plasma levels of GDF-15, high-sensitive C-reactive protein (hsCRP), and high-sensitive troponin T (hsTNT) were assessed.
RESULTS


A total of 187 patients who were included in this study, mean age was 64 ± 11 years; 85% male, 12% with type 2 diabetes, mean ejection fraction 29 ± 8, with no differences between the groups. Baseline median plasma GDF-15 was 1189 (918-1720) pg/mL with empagliflozin, and 1299 (952-1823) pg/mL for placebo. Empagliflozin increased plasma GDF-15 compared to placebo (adjusted between-groups treatment effect; ratio of change (1·09 [95% confidence interval (CI), 1.03-1.15]: p = 0.0040). The increase in plasma GDF15 was inversely associated with a decrease in left ventricular end-systolic (R = - 0.23, p = 0.031), and end-diastolic volume (R = - 0.29, p = 0.0066). There was no change in plasma hsCRP (1.09 [95%CI, 0.86-1.38]: p = 0.48) or plasma hsTNT (1.07 [95%CI, 0.97-1.19]: p = 0.18) compared to placebo. Patients with diabetes and treated with metformin demonstrated no increase in plasma GDF-15 with empagliflozin, p for interaction = 0·01.
CONCLUSION


Empagliflozin increased plasma levels of GDF-15 in patients with HFrEF, with no concomitant increase in hsTNT nor hsCRP.
TRIAL REGISTRATION


The Empire HF trial is registered with ClinicalTrials.gov, NCT03198585.",2022,"Patients with diabetes and treated with metformin demonstrated no increase in plasma GDF-15 with empagliflozin, p for interaction = 0·01.
","['This Empire HF', '187 patients who\xa0were\xa0included in this study, mean age was 64\u2009±\u200911\xa0years; 85% male, 12% with type 2 diabetes, mean ejection fraction 29\u2009±\u20098, with no differences between the groups', 'included 190\xa0patients\xa0from June 29, 2017, to September 10, 2019', 'diabetic patients', 'HFrEF patients', 'patients with heart failure', 'patients with heart failure with reduced ejection fraction (HFrEF', 'Stable ambulatory HFrEF patients with ejection fraction of\u2009≤\u200940', 'patients with HFrEF', 'Patients with diabetes and treated with']","['metformin', 'placebo', 'empagliflozin 10\xa0mg once daily, or matching placebo', 'empagliflozin', 'Sodium-glucose cotransporter-2 (SGLT2) inhibitors', 'Empagliflozin']","['left ventricular end-systolic', 'plasma GDF-15', 'plasma levels of GDF-15, high-sensitive C-reactive protein (hsCRP), and high-sensitive troponin T (hsTNT', 'end-diastolic volume', 'plasma hsCRP', 'plasma levels of GDF-15', 'Baseline median plasma GDF-15', 'plasma GDF15']","[{'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1431343', 'cui_str': 'GDF15 protein, human'}]",187.0,0.334236,"Patients with diabetes and treated with metformin demonstrated no increase in plasma GDF-15 with empagliflozin, p for interaction = 0·01.
","[{'ForeName': 'Massar', 'Initials': 'M', 'LastName': 'Omar', 'Affiliation': 'Department of Cardiology, Research Unit of Cardiology, Odense University Hospital, Odense, Denmark. Massar.omar@rsyd.dk.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Herlev, Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Højlund', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tuxen', 'Affiliation': 'Department of Cardiology, Bispebjerg, Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Julie H', 'Initials': 'JH', 'LastName': 'Larsen', 'Affiliation': 'Department of Cardiology, Research Unit of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Camilla F', 'Initials': 'CF', 'LastName': 'Andersen', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev, Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Jacob Eifer', 'Initials': 'JE', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Research Unit of Cardiology, Odense University Hospital, Odense, Denmark.'}]",Cardiovascular diabetology,['10.1186/s12933-022-01463-2']
2578,35219309,"Willingness to pay for an mHealth anti-retroviral therapy adherence and information tool: Transitioning to sustainability, Call for life randomised study experience in Uganda.","INTRODUCTION


Evidence shows benefit of digital technology for people living with human immunodeficiency virus on antiretroviral therapy adherence and retention in care, however, scalability and sustainability have scarcely been evaluated. We assessed participants' willingness to pay a fee for mHealth ""Call for life Uganda"" support, a mobile-phone based tool with the objective to assess sustainability and scalability.
METHODS


""Call for Life study"", approved by Makerere University, School of Public Health research & ethics committee, at 2 sites in Uganda, evaluated a MoTech based software ""CONNECT FOR LIFE™"" mHealth tool termed ""Call for life Uganda"". It provides short messages service or Interactive Voice Response functionalities, with a web-based interface, allows a computer to interact with humans through use of voice and tones input via keypad. Participants were randomized at 1:1 ratio to Standard of Care or standard of care plus Call for life Uganda. This sends pill reminders, visit reminders, voice messages and self-reported symptom support. At study visits 18 and 24 months, through mixed method approach we assessed mHealth sustainability and scalability. Participants were interviewed on desire to have or continue adherence support and willingness to pay a nominal fee for tool. We computed proportions willing to pay (± 95% confidence interval), stratified by study arm and predictors of willingness to continue and to pay using multivariate logistic regression model backed up by themes from qualitative interviews.
RESULTS


95% of participants were willing to continue using C4LU with 77.8% willing to pay for the service. Persons receiving care at the peri-urban clinic (OR 3.12, 95% CI 1.43-9.11.86) and those with exposure to the C4LU intervention (OR 4.2, 95% CI 1.55-11.84) were more likely to continue and pay for the service. Qualitative interviews revealed mixed feelings regarding amounts to pay, those willing to pay, argued that since they have been paying for personal phone calls/messages, they should not fail to pay for Call for life.
CONCLUSIONS


Payment for the service offers opportunities to scale up and sustain mHealth interventions which may not be priorities for government funding. A co-pay model could be acceptable to PLHIV to access mHealth services in low resource settings. Clinical Trial Number NCT02953080.",2022,"Persons receiving care at the peri-urban clinic (OR 3.12, 95% CI 1.43-9.11.86) and those with exposure to the C4LU intervention (OR 4.2, 95% CI 1.55-11.84) were more likely to continue and pay for the service.","['Participants were interviewed on desire to have or continue adherence support and willingness to pay a nominal fee for tool', 'Call for Life study"", approved by Makerere University, School of Public Health research & ethics committee, at 2 sites in Uganda', 'people living with human immunodeficiency virus', ""participants' willingness to pay a fee for mHealth""]",['Care or standard of care plus Call for life Uganda'],['mHealth sustainability and scalability'],"[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036382', 'cui_str': 'Public Health Schools'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}]",,0.059497,"Persons receiving care at the peri-urban clinic (OR 3.12, 95% CI 1.43-9.11.86) and those with exposure to the C4LU intervention (OR 4.2, 95% CI 1.55-11.84) were more likely to continue and pay for the service.","[{'ForeName': 'Agnes Bwanika', 'Initials': 'AB', 'LastName': 'Naggirinya', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Hall Lane, P.O. Box 22418, Kampala, Uganda. anaggirinya@idi.co.ug.'}, {'ForeName': 'Eunice L', 'Initials': 'EL', 'LastName': 'Kyomugisha', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Hall Lane, P.O. Box 22418, Kampala, Uganda.'}, {'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Nabaggala', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Hall Lane, P.O. Box 22418, Kampala, Uganda.'}, {'ForeName': 'Benson', 'Initials': 'B', 'LastName': 'Nasasira', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Hall Lane, P.O. Box 22418, Kampala, Uganda.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Akirana', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Hall Lane, P.O. Box 22418, Kampala, Uganda.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Oseku', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Hall Lane, P.O. Box 22418, Kampala, Uganda.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Kiragga', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Hall Lane, P.O. Box 22418, Kampala, Uganda.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Castelnuovo', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Hall Lane, P.O. Box 22418, Kampala, Uganda.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'King', 'Affiliation': 'University of California, San Francisco, USA.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Katabira', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Hall Lane, P.O. Box 22418, Kampala, Uganda.'}, {'ForeName': 'Dathan M', 'Initials': 'DM', 'LastName': 'Byonanebye', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Hall Lane, P.O. Box 22418, Kampala, Uganda.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Lamorde', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Hall Lane, P.O. Box 22418, Kampala, Uganda.'}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Parkes-Ratanshi', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Hall Lane, P.O. Box 22418, Kampala, Uganda.'}]",BMC medical informatics and decision making,['10.1186/s12911-022-01782-0']
2579,35219302,Analgesic effects of different concentrations of ropivacaine in transversalis fascia plane block during laparotomy.,"OBJECTIVE


To explore the analgesic effects of different concentrations of ropivacaine in transversalis fascia plane (TFP) block during laparotomy.
METHODS


Ninety patients who underwent laparotomy admitted to our hospital from March 2019 to March 2020 were selected as the study subjects and were divided equally into a low concentration group, a medium concentration group, and a high concentration group according to the randomized grouping method. The low concentration group adopted 0.4% ropivacaine 40 ml, the medium concentration group was given 0.5% ropivacaine 40 ml, and the high concentration group was given 0.6% ropivacaine 40 ml. The hemodynamic indexes and the incidence of adverse reactions in the two groups were compared. The Numerical Rating Scale (NRS) was used to assess the postoperative pain in the three groups, the Bruggrmann comfort scale (BCS) was used to assess the comfort level in the three groups, and the Mini-mental State Examination (MMSE) was used to evaluate the postoperative cognitive function of the three groups of patients.
RESULTS


The mean artery pressure (MAP) and heart rate (HR) levels at T1 and T2 were significantly lower in the medium concentration group than in the other two groups (P < 0.05). The low concentration group had a significantly higher NRS score at T2 than the medium concentration group and the high concentration group (P < 0.05). A significantly higher BCS score was observed in the high concentration group than the other two groups (P < 0.05). There were significantly higher Ramsay scores and MMSE scores in the medium concentration group than in the low concentration and high concentration groups (P < 0.05). The overall incidence of adverse reactions of the high concentration group was significantly higher than that of the low concentration group (P < 0.05), but showed similar results with the medium concentration group.
CONCLUSION


The medium concentration group exhibits a better analgesic effect than the low concentration group and higher safety than the high concentration group. Therefore, the use of medium concentration ropivacaine in TFP block may provide a referential basis for clinical treatment.",2022,There were significantly higher Ramsay scores and MMSE scores in the medium concentration group than in the low concentration and high concentration groups (P < 0.05).,"['transversalis fascia plane block during laparotomy', 'Ninety patients who underwent laparotomy admitted to our hospital from March 2019 to March 2020 were selected as the study subjects']","['ropivacaine', 'medium concentration ropivacaine']","['NRS score', 'Bruggrmann comfort scale (BCS', 'postoperative pain', 'Ramsay scores and MMSE scores', 'Numerical Rating Scale (NRS', 'mean artery pressure (MAP) and heart rate (HR) levels', 'analgesic effect', 'postoperative cognitive function', 'overall incidence of adverse reactions', 'hemodynamic indexes and the incidence of adverse reactions', 'BCS score']","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",90.0,0.0304151,There were significantly higher Ramsay scores and MMSE scores in the medium concentration group than in the low concentration and high concentration groups (P < 0.05).,"[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Anesthesiology, Pangang Group General Hospital, Panzhihua, Sichuan, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': ""Department of Anesthesiology, Fengdu People's Hospital, No. 33, Lutang Street, Sanhe Street, 408200, Fengdu County, Chongqing, China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Fengdu People's Hospital, No. 33, Lutang Street, Sanhe Street, 408200, Fengdu County, Chongqing, China. ke41987158637306@126.com.""}, {'ForeName': 'Shaojin', 'Initials': 'S', 'LastName': 'Bu', 'Affiliation': ""Department of Anesthesiology, Fengdu People's Hospital, No. 33, Lutang Street, Sanhe Street, 408200, Fengdu County, Chongqing, China.""}, {'ForeName': 'Yalin', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': ""Department of Anesthesiology, Fengdu People's Hospital, No. 33, Lutang Street, Sanhe Street, 408200, Fengdu County, Chongqing, China.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Xiong', 'Affiliation': ""Department of Anesthesiology, Fengdu People's Hospital, No. 33, Lutang Street, Sanhe Street, 408200, Fengdu County, Chongqing, China.""}, {'ForeName': 'Jintao', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': ""Department of Anesthesiology, Fengdu People's Hospital, No. 33, Lutang Street, Sanhe Street, 408200, Fengdu County, Chongqing, China.""}]",BMC anesthesiology,['10.1186/s12871-022-01595-8']
2580,35219762,Long-Term Kidney and Systemic Effects Of Calorie Restriction in Overweight or Obese Type 2 Diabetic Patients (C.Re.S.O. 2 Randomized Controlled Trial).,"AIMS


In type 2 diabetic patients with obesity, hyperfiltration is a risk factor for accelerated glomerular filtration rate (GFR) decline and is ameliorated by calorie restriction (CR). We assessed whether CR-induced amelioration of hyperfiltration could translate into slower long-term GFR decline in this population.
METHODS


In this academic, single-center, parallel-group, prospective, randomized, open-label, blinded endpoint trial, consenting >40-year-old patients with type 2 diabetes, BMI ≥27 kg/m 2 , creatinine <1.2 mg/dL and albuminuria ≤300 mg/24h were randomized (1:1) to two-year 25% CR (n=53) or standard diet (SD, n=50). Primary outcome was 6-month measured GFR. Analyses were by modified intention-to-treat.
RESULTS


At 6 months GFR decreased by 5.16±10.03 mL/min (P=0.001) with CR, and by 0.98±9.71 mL/min (P=0.497) with SD. Between-group difference was significant (P=0.044). GFR decline from 6 to 24 months was significant with SD (P<0.01), but not with CR (P=0.075). Between-group difference, however, was not significant (P=NS). Body weight, BMI, waist circumference, systolic blood pressure, HbA1c, blood glucose, serum triglycerides decreased and ApoA-1 concentration increased with CR. No changes were observed with SD. Between-group differences .were significant. CR was tolerated well.
CONCLUSIONS


In obese type 2 diabetic patients, CR ameliorated glomerular hyperfiltration and several cardiovascular risk factors, and blunted long-term GFR decline.",2022,"At 6 months GFR decreased by 5.16±10.03 mL/min (P=0.001) with CR, and by 0.98±9.71 mL/min (P=0.497) with SD.","['consenting >40-year-old patients with type 2 diabetes, BMI ≥27 kg/m 2 , creatinine <1.2 mg/dL and albuminuria ≤300 mg/24h', 'Overweight or Obese Type 2 Diabetic Patients']","['Calorie Restriction', 'standard diet']","['6-month measured GFR', 'glomerular filtration rate (GFR) decline', 'Body weight, BMI, waist circumference, systolic blood pressure, HbA1c, blood glucose, serum triglycerides decreased and ApoA-1 concentration', 'CR ameliorated glomerular hyperfiltration and several cardiovascular risk factors', 'GFR decline']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0022663', 'cui_str': 'Glomerulus structure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0318283,"At 6 months GFR decreased by 5.16±10.03 mL/min (P=0.001) with CR, and by 0.98±9.71 mL/min (P=0.497) with SD.","[{'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Ruggenenti', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Centro di Ricerche Cliniche per le Malattie Rare ""Aldo e Cele Daccò"", Bergamo, Italy; Unit of Nephrology, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Cortinovis', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Centro di Ricerche Cliniche per le Malattie Rare ""Aldo e Cele Daccò"", Bergamo, Italy.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Trillini', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Centro di Ricerche Cliniche per le Malattie Rare ""Aldo e Cele Daccò"", Bergamo, Italy.'}, {'ForeName': 'Aneliya', 'Initials': 'A', 'LastName': 'Parvanova', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Centro di Ricerche Cliniche per le Malattie Rare ""Aldo e Cele Daccò"", Bergamo, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Abbate', 'Affiliation': 'Research group on Global Health and Human Development, University of the Balearic Islands (UIB)and Health Research Institute of the Balearic Islands (IdISBa), both in Palma, Spain.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Satriano', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Centro di Ricerche Cliniche per le Malattie Rare ""Aldo e Cele Daccò"", Bergamo, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Salvetti', 'Affiliation': 'Unit of Ophthalmology, Casa di cura Beato Palazzolo, Bergamo, Italy.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Bossi', 'Affiliation': 'Unit of Diabetology and Metabolic Diseases, Azienda Socio-Sanitaria Territoriale Bergamo Ovest, Treviglio-Caravaggio-Romano, Bergamo, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Trevisan', 'Affiliation': 'Unit of Endocrinology 1 and Diabetology, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Perna', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Centro di Ricerche Cliniche per le Malattie Rare ""Aldo e Cele Daccò"", Bergamo, Italy.'}, {'ForeName': 'Tobia', 'Initials': 'T', 'LastName': 'Peracchi', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Centro di Ricerche Cliniche per le Malattie Rare ""Aldo e Cele Daccò"", Bergamo, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Rubis', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Centro di Ricerche Cliniche per le Malattie Rare ""Aldo e Cele Daccò"", Bergamo, Italy.'}, {'ForeName': 'Olimpia', 'Initials': 'O', 'LastName': 'Diadei', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Centro di Ricerche Cliniche per le Malattie Rare ""Aldo e Cele Daccò"", Bergamo, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Martinetti', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Centro di Ricerche Cliniche per le Malattie Rare ""Aldo e Cele Daccò"", Bergamo, Italy.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Gaspari', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Centro di Ricerche Cliniche per le Malattie Rare ""Aldo e Cele Daccò"", Bergamo, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Fontana', 'Affiliation': 'Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney, and Department of Endocrinology, Royal Prince Alfred Hospital, both in Sydney, NSW, Australia; Department of Clinical and Experimental Sciences, Brescia University Medical School, Brescia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Remuzzi', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Centro di Ricerche Cliniche per le Malattie Rare ""Aldo e Cele Daccò"", Bergamo, Italy. Electronic address: giuseppe.remuzzi@marionegri.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes research and clinical practice,['10.1016/j.diabres.2022.109804']
2581,35219749,"Chemoprevention of cutaneous squamous cell carcinoma and its precursors in solid organ transplant recipients using topical sirolimus: a randomized, double-blind, placebo-controlled pilot trial.",,2022,,['cutaneous squamous cell carcinoma'],"['topical sirolimus', 'placebo']",[],"[{'cui': 'C0553723', 'cui_str': 'Squamous cell carcinoma of skin'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.49334,,"[{'ForeName': 'Sharene', 'Initials': 'S', 'LastName': 'Chong', 'Affiliation': 'The University of Queensland, UQ Diamantina Institute, Experimental Dermatology Group, Brisbane Australia.'}, {'ForeName': 'Ho Yi', 'Initials': 'HY', 'LastName': 'Wong', 'Affiliation': 'The University of Queensland, UQ Diamantina Institute, Experimental Dermatology Group, Brisbane Australia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Althabteh', 'Affiliation': 'The University of Queensland, UQ Diamantina Institute, Experimental Dermatology Group, Brisbane Australia.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cox', 'Affiliation': 'The University of Queensland, UQ Diamantina Institute, Experimental Dermatology Group, Brisbane Australia; Princess Alexandra Hospital, Department of Dermatology, Brisbane Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stevenson', 'Affiliation': 'Princess Alexandra Hospital, Department of Dermatology, Brisbane Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'The University of Queensland, UQ Diamantina Institute, Experimental Dermatology Group, Brisbane Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Griffin', 'Affiliation': 'Princess Alexandra Hospital, Department of Nephrology and Transplantation services, Brisbane Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Isbel', 'Affiliation': 'Princess Alexandra Hospital, Department of Nephrology and Transplantation services, Brisbane Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Siller', 'Affiliation': 'Princess Alexandra Hospital, Department of Dermatology, Brisbane Australia.'}, {'ForeName': 'H Peter', 'Initials': 'HP', 'LastName': 'Soyer', 'Affiliation': 'Princess Alexandra Hospital, Department of Dermatology, Brisbane Australia; The University of Queensland, UQ Diamantina Institute, Dermatology Research Centre, Brisbane Australia.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schaider', 'Affiliation': 'Princess Alexandra Hospital, Department of Dermatology, Brisbane Australia; The University of Queensland, UQ Diamantina Institute, Dermatology Research Centre, Brisbane Australia; Sunshine Coast Hospital and Health Service, Department of Dermatology, Birtinya, Queensland, Australia.'}, {'ForeName': 'Edwige', 'Initials': 'E', 'LastName': 'Roy', 'Affiliation': 'The University of Queensland, UQ Diamantina Institute, Experimental Dermatology Group, Brisbane Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Campbell', 'Affiliation': 'Princess Alexandra Hospital, Department of Nephrology and Transplantation services, Brisbane Australia.'}, {'ForeName': 'Adele C', 'Initials': 'AC', 'LastName': 'Green', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia; CRUK Manchester Institute and Faculty of Biology Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Kiarash', 'Initials': 'K', 'LastName': 'Khosrotehrani', 'Affiliation': 'The University of Queensland, UQ Diamantina Institute, Experimental Dermatology Group, Brisbane Australia; Princess Alexandra Hospital, Department of Dermatology, Brisbane Australia; The University of Queensland, UQ Diamantina Institute, Dermatology Research Centre, Brisbane Australia. Electronic address: k.khosrotehrani@uq.edu.au.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2022.02.039']
2582,35222874,Outcomes of Visualized Puncture Needle and Small Needle-Knife Therapy in Primary Frozen Shoulder Based on Multimodal Ultrasound Imaging.,"Objective


To compare the outcomes of visualized puncture needle and small needle-knife therapy in 68 patients with primary frozen shoulder.
Method


Sixty-eight patients with primary frozen shoulder were recruited and randomly divided into two groups, with 34 patients in each group. In the treatment group, an ultrasound-guided 18G-PTC puncture needle was inserted into the joint space, followed by a liquid injection until complete lysis and dissociation of the intraarticular adhesion were achieved. Then, the lesser tuberosity of the coracoid and humerus, the intertubercular groove of the humerus, and the greater tuberosity of the humerus were stripped, first vertically and then horizontally, by an amplitude ≦ 0.5 cm per treatment. This treatment procedure was performed once per week, and each cycle covered three treatments. The small needle-knife therapy was set as a control, and the efficacy was observed.
Result


The visualized puncture needle significantly outperformed the small needle-knife therapy in overall efficacy, UCLA scores of the shoulder joint, shoulder mobility, and muscle elasticity and thickness.
Conclusion


The efficacy of the visualized puncture needle for primary frozen shoulder was better compared to the small needle-knife therapy. The former was safer and more convenient, which caused less pain to patients and took effect more quickly. In a word, the visualized puncture needle for primary frozen shoulder is worthy of clinical popularization.",2022,"The visualized puncture needle significantly outperformed the small needle-knife therapy in overall efficacy, UCLA scores of the shoulder joint, shoulder mobility, and muscle elasticity and thickness.
","['Method\n\n\nSixty-eight patients with primary frozen shoulder', '68 patients with primary frozen shoulder']","['Visualized Puncture Needle and Small Needle-Knife Therapy', 'visualized puncture needle and small needle-knife therapy', 'visualized puncture needle', 'ultrasound-guided 18G-PTC puncture needle', 'small needle-knife therapy']","['overall efficacy, UCLA scores of the shoulder joint, shoulder mobility, and muscle elasticity and thickness']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0181464', 'cui_str': 'Needle knife'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0456637', 'cui_str': '18G'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231494', 'cui_str': 'Muscle elasticity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",68.0,0.0483348,"The visualized puncture needle significantly outperformed the small needle-knife therapy in overall efficacy, UCLA scores of the shoulder joint, shoulder mobility, and muscle elasticity and thickness.
","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Northwest Minzu University, No.1 Xibei New Village, Chengguan District, Lanzhou City, Gansu Province 730030, China.'}, {'ForeName': 'Baoli', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Northwest Minzu University, No.1 Xibei New Village, Chengguan District, Lanzhou City, Gansu Province 730030, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Northwest Minzu University, No.1 Xibei New Village, Chengguan District, Lanzhou City, Gansu Province 730030, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Northwest Minzu University, No.1 Xibei New Village, Chengguan District, Lanzhou City, Gansu Province 730030, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Northwest Minzu University, No.1 Xibei New Village, Chengguan District, Lanzhou City, Gansu Province 730030, China.'}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Northwest Minzu University, No.1 Xibei New Village, Chengguan District, Lanzhou City, Gansu Province 730030, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Gansu University of Traditional Chinese Medicine, Lanzhou, Gansu 730000, China.'}]",Journal of healthcare engineering,['10.1155/2022/1076112']
2583,35222785,The life history theory of the Lord of the Rings: a randomized controlled trial of using fact versus fiction to teach life history theory.,"Does asking students to apply concepts from evolution to a fictional context, compared to a novel biological context, improve their understanding, exam performance or enjoyment of the material? Or does it harm their education by taking time away from true biology? At our institution, we sometimes ask students to apply life history theory to species from fictional movies, television shows or books. Previously, we had used a factual article on life history theory, to supplement our textbook. We wrote an alternative introduction to life history theory (included in the additional files for educational use), using Tolkien's fictional species from his Lord of the Rings books. We also introduce the biological species definition, sexual selection, sexual dimorphism, kin selection, and the handicap principle, as those concepts arose naturally in the discussion of the fictional species. Life history theory predicts strong correlations between traits affecting reproduction, growth and survival, which are all shaped by the ecology of the species. Thus, we can teach life history theory by asking students to infer traits and aspects of the ecology of a fictional species that have never been described, based on the partial information included in the fictional sources. In a large, third year undergraduate evolution course at Arizona State University, we randomized 16 tutorial sections of a total of 264 students to either read our article on the life history theory of Lord of the Rings, or the factual article we had used previously in the course. We found that the exam performance on life history questions for the two groups were almost identical, except that fans of The Lord of the Rings who had read our article did better on the exam. Enjoyment, engagement and interest in life history theory was approximately a full point higher on a 5-point Likert scale for the students that had read the fictional article, and was highly statistically significantly different (T-test  p  < 0.001 for all questions). There was no difference between the two groups in their familiarity or enjoyment of The Lord of the Rings stories themselves. Reading the article that taught life history theory by applying it to the species of The Lord of the Rings neither helped nor harmed exam performance, but did significantly improve student enjoyment, engagement and interest in life history theory, and even improved exam scores in students who liked The Lord of the Rings. Using fiction to teach science may also help to engage non-traditional students, such as world-builders, outside of our institutions of education. By encouraging students to apply the scientific ideas to their favorite stories from their own cultures, we may be able to improve both inclusivity and education.
Supplementary Information


The online version contains supplementary material available at 10.1186/s12052-022-00160-8.",2022,There was no difference between the two groups in their familiarity or enjoyment of The Lord of the Rings stories themselves.,"['In a large, third year undergraduate evolution course at Arizona State University, we randomized 16 tutorial sections of a total of 264 students']",[],"['5-point Likert scale', 'life history questions', 'Enjoyment, engagement and interest in life history theory', 'student enjoyment, engagement and interest in life history theory']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0003787', 'cui_str': 'Arizona - US state'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C4280039', 'cui_str': 'Life History Theory'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",16.0,0.0535824,There was no difference between the two groups in their familiarity or enjoyment of The Lord of the Rings stories themselves.,"[{'ForeName': 'Carlo C', 'Initials': 'CC', 'LastName': 'Maley', 'Affiliation': 'Arizona Cancer Evolution Center, Biodesign Institute and School of Life Sciences, Arizona State University, Tempe, USA.'}, {'ForeName': 'Sareh', 'Initials': 'S', 'LastName': 'Seyedi', 'Affiliation': 'Arizona Cancer Evolution Center, Biodesign Institute and School of Life Sciences, Arizona State University, Tempe, USA.'}]",Evolution,['10.1186/s12052-022-00160-8']
2584,35217325,Pilot randomized controlled trial of the Yoga for HEART intervention in community-dwelling older adults.,"Physical activity reduces cardiovascular risk; however, many older adults do not engage in recommended levels. Theory-based interventions supporting motivation for physical activity are limited. This pilot study evaluated the feasibility of Yoga for Health Empowerment and Realizing Transformation (HEART), a theory-based intervention combining motivation and yoga-based physical activity. Feasibility was addressed as acceptability, demand, implementation fidelity, and limited efficacy in promoting physical activity, cardiovascular health, and mechanisms of action. Sedentary older adults (m = 65 years old, sd = 8.5) were randomized to Yoga for HEART (n=8) or Active Control (n=7) conditions. Yoga for HEART was: (a) acceptable, (b) retention 73%, (c) implemented as planned. A significant main effect for body mass index (BMI) was found in Yoga for HEART participants (p = .02). No significant effects were found for physical activity, other cardiovascular outcomes, or mechanisms of action. Yoga for HEART is feasible and recommended for further testing.",2022,A significant main effect for body mass index (BMI) was found in Yoga for HEART participants (p = .02).,"['Sedentary older adults (m\xa0=\xa065 years old, sd\xa0=\xa08.5', 'community-dwelling older adults']","['Yoga for HEART', 'Yoga for Health Empowerment and Realizing Transformation (HEART', 'Active Control', 'Yoga for HEART intervention']","['physical activity, other cardiovascular outcomes, or mechanisms of action', 'body mass index (BMI', 'Physical activity reduces cardiovascular risk']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0274187,A significant main effect for body mass index (BMI) was found in Yoga for HEART participants (p = .02).,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barrows', 'Affiliation': ""Edson College of Nursing and Health Innovation, Arizona State University, 550 N. 3(rd) St., Phoenix, AZ 85004, United States; Present address: Children's Hospital of Orange County, 1201 W. La Veta Ave., Orange, CA 92868, United States. Electronic address: jbarrows@choc.org.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Fleury', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, 550 N. 3(rd) St., Phoenix, AZ 85004, United States. Electronic address: jfleury@asu.edu.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2022.02.003']
2585,35217302,A certified child life specialist influences the emotional response during polysomnography setup.,"OBJECTIVES


To examine if the presence of a certified child life specialist (CCLS) had a positive impact on patient emotion at the time of polysomnography setup and to determine the optimal timing of CCLS intervention prior to polysomnography (PSG) in our sleep center.
METHODS


We implemented a study which measured the impact of a CCLS on the emotional manifestation score (EMS) of pediatric patients (4 months-17 years, median 7 years) during PSG setup. CCLS intervention was either at the time of sleep medicine consultation (daytime) or during PSG setup (evening). We used Emotional Manifestations Scores (EMS) as well as patient/caregiver satisfaction data to measure the impact of a CCLS and inform decision-making regarding ongoing employment of a CCLS in our sleep lab.
RESULTS


High EMS scores were noted during PSG setup in all groups indicating the emotional distress of children undergoing PSG. The EMS improved more when CCLS was present at the time of PSG setup. Statistically significant improvements occurred in level of cooperation, pain/discomfort, and child coping. Based on the results of the study, we hired a CCLS to work in our sleep center at the time of PSG setup 2 evenings per week.
CONCLUSIONS


PSG is emotionally stressful for pediatric patients as seen on EMS. A CCLS present in the evening at our sleep lab led to an improvement in EMS in children being prepared for PSG set-up. After implementation of a CCLS two nights per week in our sleep lab, parents/caregiver satisfaction scores were higher on nights a CCLS was present at setup.",2022,"Statistically significant improvements occurred in level of cooperation, pain/discomfort, and child coping.","['pediatric patients (4 months-17 years, median 7 years) during PSG setup']","['CCLS', 'CCLS intervention', 'certified child life specialist (CCLS', 'CCLS intervention prior to polysomnography (PSG']","['emotional distress', 'emotional response', 'emotional manifestation score (EMS', 'caregiver satisfaction scores', 'level of cooperation, pain/discomfort, and child coping', 'Emotional Manifestations Scores (EMS']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]","[{'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319173', 'cui_str': 'Caregiver wellbeing status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.0486537,"Statistically significant improvements occurred in level of cooperation, pain/discomfort, and child coping.","[{'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Baughn', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Rochester, MN, USA. Electronic address: baughn.julie@mayo.edu.'}, {'ForeName': 'Hannah G', 'Initials': 'HG', 'LastName': 'Lechner', 'Affiliation': 'Department of Management Engineering & Consulting, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Herold', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Brown', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Eibner', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sullivan', 'Affiliation': 'Child Life Department of Nursing, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Dagney Willey', 'Initials': 'DW', 'LastName': 'Adamson', 'Affiliation': 'Child Life Department of Nursing, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rodemeyer', 'Affiliation': 'Child Life Department of Nursing, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Channing M', 'Initials': 'CM', 'LastName': 'Sorensen', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cleveland', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Timothy I', 'Initials': 'TI', 'LastName': 'Morgenthaler', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Lloyd', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Rochester, MN, USA.'}]",Sleep medicine,['10.1016/j.sleep.2022.01.018']
2586,35217298,"Satiety, glycemic profiles, total antioxidant capacity, and postprandial glycemic responses to different sugars in healthy Malaysian adults.","OBJECTIVES


We investigated a low-glycemic index (GI), minimally refined brown sugar (MRBS) that retains a consistent amount of antioxidant polyphenols. This study aimed to determine whether MRBS has a lower postprandial glycemic response and GI value compared with other types of refined sugar (RS). Low glycemic response foods are also reported to increase satiety. Accordingly, we also evaluated satiety profiles, glycemic profiles (glucose, insulin, and glucagon), and total antioxidant capacity (TAC).
METHODS


This work shows the results of two single-blind, cross-over studies (studies 1 and 2). For each study 14 healthy Malay individuals with a normal body mass index were recruited. In study 1, capillary blood samples were used to determine the GI of the tested sugars. Venous blood samples were used in study 2 to measure the concentrations of satiety hormones (peptide tyrosine, C-peptide, glucagon-like peptide-1, and leptin), TAC, plasma glucose, insulin, and glucagon concentrations at baseline (0 min) and at 60 and 120 min after consumption of the MRBS and RS formulated jellies.
RESULTS


The incremental area under the curve of glucose positive control (312 ± 62.54 mmol.min/L) was significantly higher than that of other types of sucrose (P < 0.05). MRBS (GI: 54 ± 4.5 mmol.min/L) and brown sugar (GI: 50 ± 5.0 mmol.min/L) were categorized as low GI, and RS (GI: 64 ± 5.73 mmol.min/L) was in the medium category, which was significantly lower than the GI of glucose (GI: 100 mmol.min/L; P < 0.05). Likewise, there was a significant difference in satiety profiles (peptide tyrosine and C-peptide), glycemic profile (glucagon), and TAC (P < 0.05) between RS and MRBS jellies.
CONCLUSIONS


The results of our work show that MRBS had a lower GI (study 1), and better satiety, glycemic profiles, and TAC (study 2) compared with RS.",2021,"Likewise, there was a significant difference in satiety profiles (peptide tyrosine and C-peptide), glycemic profile (glucagon), and TAC (P < 0.05) between RS and MRBS jellies.
","['14 healthy Malay individuals with a normal body mass index were recruited', 'healthy Malaysian adults']","['GI of glucose (GI', 'MRBS ', 'MRBS', 'low-glycemic index (GI), minimally refined brown sugar (MRBS']","['Satiety, glycemic profiles, total antioxidant capacity, and postprandial glycemic responses', 'concentrations of satiety hormones (peptide tyrosine, C-peptide, glucagon-like peptide-1, and leptin), TAC, plasma glucose, insulin, and glucagon concentrations', 'satiety profiles, glycemic profiles (glucose, insulin, and glucagon), and total antioxidant capacity (TAC', 'satiety, glycemic profiles, and TAC', 'satiety profiles (peptide tyrosine and C-peptide), glycemic profile (glucagon), and TAC', 'satiety', 'postprandial glycemic response and GI value']","[{'cui': 'C0024549', 'cui_str': 'Malay language'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231253', 'cui_str': 'Normal body mass index'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0459825', 'cui_str': 'Brown sugar'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}]","[{'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0536168,"Likewise, there was a significant difference in satiety profiles (peptide tyrosine and C-peptide), glycemic profile (glucagon), and TAC (P < 0.05) between RS and MRBS jellies.
","[{'ForeName': 'Azrina', 'Initials': 'A', 'LastName': 'Azlan', 'Affiliation': 'Department of Nutrition, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia; Research Centre of Excellence for Nutrition and Noncommunicable Diseases, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia; Halal Products Research Institute, Universiti Putra Malaysia, Serdang, Selangor, Malaysia. Electronic address: azrinaaz@upm.edu.my.'}, {'ForeName': 'Samarghand', 'Initials': 'S', 'LastName': 'Ebadi', 'Affiliation': 'Department of Nutrition, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Barakatun Nisak Mohd', 'Initials': 'BNM', 'LastName': 'Yusof', 'Affiliation': 'Department of Nutrition, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia; Research Centre of Excellence for Nutrition and Noncommunicable Diseases, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Nur Maziah Hanum', 'Initials': 'NMH', 'LastName': 'Othman', 'Affiliation': 'Department of Nutrition, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kannar', 'Affiliation': 'Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Sharmin', 'Initials': 'S', 'LastName': 'Sultana', 'Affiliation': 'Department of Nutrition, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia; Halal Products Research Institute, Universiti Putra Malaysia, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Zhafarina', 'Initials': 'Z', 'LastName': 'Mahmood', 'Affiliation': 'Central Sugars Refinery Sdn. Bhd., Batu Tiga, Shah Alam, Selangor, Malaysia.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2021.111551']
2587,35217772,Dapagliflozin plus exenatide on patients with type 2 diabetes awaiting bariatric surgery in the DEXBASU study.,"The glucagon-like peptide-1 receptor agonist family together with the renal sodium/glucose cotransporter-2 inhibitors have garnered interest as potential therapeutic agents for subjects with type 2 diabetes and obesity. In these patients, bariatric surgery is indicated based in a BMI ≥ 35 kg/m 2 . A 24-week non-blinded, randomized pilot study to assess the efficacy of subcutaneous exenatide 2.0 mg once weekly plus oral dapagliflozin 10 mg once daily (Group A) compared to a control group (Group B) in 56 patients with type 2 diabetes awaiting bariatric surgery was conducted (EudraCTid.: 2017-001,454-33). Both groups received an energy-deficit low-fat diet. The primary endpoint was the proportion of patients running off the criteria for bariatric surgery at the end of the follow-up period (BMI ≤ 35.0 kg/m 2  or a BMI ≤ 40.0 kg/m 2  plus an HbA1c ≤ 6.0%). Changes in the BMI were also of interest. The proportion of patients who ran off the criteria for bariatric surgery was larger in Group A than in the control group (45.8% vs. 12.0%, p = 0.010). Participants in Group A exhibited an absolute decrease in body weight and BMI of 8.1 kg (95%IC: - 11.0 to - 5.2) and 3.3 kg/m 2  (95%IC: - 4.5 to - 2.2), respectively (p < 0.001 for both in comparison with Group B). A higher percentage of participants in Group A reached a BMI < 35 kg/m 2  (45.8 vs 12.0%) and lost > 10% of their initial body weight (20.8 vs 0%) compared to Group B. The combination of exenatide plus dapagliflozin appears as a strategic option to reduce the waiting list for bariatric surgery, especially in those patients with type 2 diabetes.",2022,"The proportion of patients who ran off the criteria for bariatric surgery was larger in Group A than in the control group (45.8% vs. 12.0%, p = 0.010).","['56 patients with type 2 diabetes awaiting bariatric surgery was conducted (EudraCTid', 'patients with type 2 diabetes awaiting bariatric surgery in the DEXBASU study', 'subjects with type 2 diabetes and obesity', 'patients with type 2 diabetes']","['subcutaneous exenatide 2.0\xa0mg once weekly plus oral dapagliflozin 10', 'energy-deficit low-fat diet', 'Dapagliflozin plus exenatide', 'exenatide plus dapagliflozin']","['proportion of patients running off the criteria for bariatric surgery', 'proportion of patients who ran off the criteria for bariatric surgery', 'body weight and BMI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",56.0,0.155163,"The proportion of patients who ran off the criteria for bariatric surgery was larger in Group A than in the control group (45.8% vs. 12.0%, p = 0.010).","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'López-Cano', 'Affiliation': 'Endocrinology and Nutrition Department, University Hospital Arnau de Vilanova de Lleida, Obesity, Diabetes and Metabolism Research Group (ODIM), Institut de Recerca Biomèdica de Lleida (IRBLleida), University of Lleida, Avda. Rovira Roure 80, 25198, Lleida, Spain.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Santos', 'Affiliation': 'Endocrinology and Nutrition Department, University Hospital Arnau de Vilanova de Lleida, Obesity, Diabetes and Metabolism Research Group (ODIM), Institut de Recerca Biomèdica de Lleida (IRBLleida), University of Lleida, Avda. Rovira Roure 80, 25198, Lleida, Spain.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Sánchez', 'Affiliation': 'Endocrinology and Nutrition Department, University Hospital Arnau de Vilanova de Lleida, Obesity, Diabetes and Metabolism Research Group (ODIM), Institut de Recerca Biomèdica de Lleida (IRBLleida), University of Lleida, Avda. Rovira Roure 80, 25198, Lleida, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Martí', 'Affiliation': 'Endocrinology and Nutrition Department, University Hospital Arnau de Vilanova de Lleida, Obesity, Diabetes and Metabolism Research Group (ODIM), Institut de Recerca Biomèdica de Lleida (IRBLleida), University of Lleida, Avda. Rovira Roure 80, 25198, Lleida, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bueno', 'Affiliation': 'Endocrinology and Nutrition Department, University Hospital Arnau de Vilanova de Lleida, Obesity, Diabetes and Metabolism Research Group (ODIM), Institut de Recerca Biomèdica de Lleida (IRBLleida), University of Lleida, Avda. Rovira Roure 80, 25198, Lleida, Spain.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Gutiérrez-Carrasquilla', 'Affiliation': 'Endocrinology and Nutrition Department, University Hospital Arnau de Vilanova de Lleida, Obesity, Diabetes and Metabolism Research Group (ODIM), Institut de Recerca Biomèdica de Lleida (IRBLleida), University of Lleida, Avda. Rovira Roure 80, 25198, Lleida, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Lecube', 'Affiliation': 'Endocrinology and Nutrition Department, University Hospital Arnau de Vilanova de Lleida, Obesity, Diabetes and Metabolism Research Group (ODIM), Institut de Recerca Biomèdica de Lleida (IRBLleida), University of Lleida, Avda. Rovira Roure 80, 25198, Lleida, Spain. alecube@gmail.com.'}]",Scientific reports,['10.1038/s41598-022-07250-z']
2588,35218045,Correspondence to: Phase 2a randomized clinical trial of dupilumab (anti-IL-4Rα) for alopecia areata patients.,,2022,,['alopecia areata patients'],['dupilumab (anti-IL-4Rα'],[],"[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}]",[],,0.290052,,"[{'ForeName': 'Eamonn', 'Initials': 'E', 'LastName': 'Maher', 'Affiliation': 'Department of Dermatology, NYU Langone, New York City, New York, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Martiniuk', 'Affiliation': 'JME Group, Inc and Psychogenics Center, Parasmus, New Jersey, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Levis', 'Affiliation': 'Department of Dermatology, Bellevue Hospital, New York City, New York, USA.'}]",Allergy,['10.1111/all.15185']
2589,35218324,Ligelizumab improves sleep interference and disease burden in patients with chronic spontaneous urticaria.,"BACKGROUND


Chronic spontaneous urticaria (CSU) negatively impacts patients' sleep, thereby reducing health-related quality of life (HRQoL). Half of patients with inadequately controlled CSU report sleep interference often or every night, which can lead to depression, anxiety, social, and work-related problems.
METHODS


This randomized, double-blind, placebo-controlled Phase 2b core study (NCT02477332) included adult patients ≥18 years with moderate to severe CSU inadequately controlled with H 1  -antihistamines. The current analysis includes patients randomized to receive ligelizumab 72 or 240 mg, omalizumab 300 mg or placebo every 4 weeks (q4w) for five injections over 20 weeks with treatment-free follow-up for 24 weeks. Patients could enter the open-label extension study (NCT02649218) from Week 32 onwards if their weekly urticaria activity score was ≥12, which included an open-label treatment (52 weeks of ligelizumab 240 mg q4w) and a 48-week post-treatment follow-up. Weekly Sleep Interference Scores (SIS7, range 0 [no interference]-21 [substantial interference]), Weekly Activity Interference Score (AIS7), Dermatology Life Quality Index (DLQI) scores, and Overall Work Impairment were assessed.
RESULTS


Mean baseline SIS7 scores were balanced between the treatment arms for ligelizumab 72 mg (n = 84) and 240 mg (n = 85), omalizumab 300 mg (n = 85), and placebo (n = 43). By Week 12, patients experienced large improvements in sleep interference, with least square mean (standard error) changes from baseline (CFB) in SIS7 of -7.84 (0.58), -7.55 (0.61), -6.98 (0.60), and -5.85 (0.81), respectively. By Week 12, CFB in AIS7 were -8.25 (0.57), -8.25 (0.59), -7.30 (0.60), and -5.62 (0.79), DLQI scores were -9.79 (0.77), -9.93 (0.81), -8.35 (0.79), and -6.99 (1.11), and Overall Work Impairment scores were -28.96 (3.73), -30.76 (3.71), -25.74 (3.91), and -20.13 (5.10) for ligelizumab 72 and 240 mg, omalizumab 300 mg and placebo, respectively. Improvements in each patient-reported outcome were sustained with ligelizumab 240 mg treatment during the extension study.
CONCLUSIONS


Ligelizumab showed effective and sustained responses in managing sleep interference in patients with CSU, and numerically higher responses than with omalizumab and placebo. Treating the symptoms of CSU with ligelizumab improved disease burden, HRQoL, and markedly improved sleep quality.",2022,"Mean baseline SIS7 scores were balanced between the treatment arms for ligelizumab 72 mg (n = 84) and 240 mg (n = 85), omalizumab 300 mg (n = 85), and placebo (n = 43).","['patients with chronic spontaneous urticaria', 'adult patients ≥18\xa0years with moderate to severe CSU inadequately controlled with H 1  -antihistamines', 'patients with CSU']","['Ligelizumab', 'ligelizumab', 'placebo', 'ligelizumab 240\xa0mg q4w) and a 48-week post-treatment follow-up', 'ligelizumab 72 or 240\xa0mg, omalizumab 300\xa0mg or placebo', 'omalizumab and placebo', 'omalizumab']","['sleep quality', 'no interference]-21 [substantial interference]), Weekly Activity Interference Score (AIS7), Dermatology Life Quality Index (DLQI) scores, and', 'sleep interference', 'Mean baseline SIS7 scores', 'Weekly Sleep Interference Scores (SIS7, range 0', 'Overall Work Impairment', 'CFB in AIS7', 'sleep interference and disease burden', 'Overall Work Impairment scores', 'DLQI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]","[{'cui': 'C4041919', 'cui_str': 'ligelizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.308319,"Mean baseline SIS7 scores were balanced between the treatment arms for ligelizumab 72 mg (n = 84) and 240 mg (n = 85), omalizumab 300 mg (n = 85), and placebo (n = 43).","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Giménez-Arnau', 'Affiliation': 'Department of Dermatology, Hospital del Mar, Institut Mar d´Investigacions Mèdiques, Universitat Autònoma, Barcelona, Spain.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': 'Department of Dermatology and Allergy, Dermatological Allergology, Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bernstein', 'Affiliation': 'Bernstein Allergy Group and Bernstein Clinical Research Center, College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Staubach', 'Affiliation': 'Department of Dermatology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Barbier', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hua', 'Affiliation': 'China Novartis Institutes for Biomedical Research Co. Ltd, Shanghai, China.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Severin', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Yolandi', 'Initials': 'Y', 'LastName': 'Joubert', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Janocha', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Maria-Magdalena', 'Initials': 'MM', 'LastName': 'Balp', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Clinical and translational allergy,['10.1002/clt2.12121']
2590,34856171,Alzheimer's Disease THErapy With NEuroaid (ATHENE): A Randomized Double-Blind Delayed-Start Trial.,"OBJECTIVES


Preclinical and clinical studies indicate a role for MLC901 (NeuroAiD II) in Alzheimer's disease (AD). The primary aim was to investigate its safety as add-on therapy to standard treatment and the secondary aims its effect on cognition and slowing disease progression.
DESIGN


Randomized double-blind placebo-controlled delayed-start study.
SETTING AND PARTICIPANT


Patients with mild to moderate probable AD by NINCDS-ADRDA criteria, stable on acetylcholinesterase inhibitors or memantine (n = 125), were randomized to receive MLC901 (early starters) or placebo (delayed starters) for 6 months, followed by a further 6 months when all patients received MLC901, in a delayed-start design (clinical trial registration: ClinicalTrials.gov, NCT03038035).
METHODS


The primary outcome measure was occurrence of serious adverse events (SAEs) at 6 months. Secondary outcomes included the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and other assessment scales.
RESULTS


There was no significant difference in the risk of SAEs between early and delayed starters at month (M) 6 (22.6% vs 27.0%, risk difference -4.4%, 90% CI -16.9% to 8.3%). Similarly, there was no significant difference in the risk of adverse events and the occurrence of stroke or vascular events between early and delayed starters throughout the 12-month study period. Early starters did not differ significantly on ADAS-Cog from delayed starters at M6 [mean difference (MD) -1.0, 95% CI -3.3 to 1.3] and M12 (MD -2.35, 95% CI -5.45 to 0.74) on intention-to-treat analysis. Other cognitive assessment scales did not show significant differences.
CONCLUSIONS AND IMPLICATIONS


This study of 125 persons with dementia found no evidence of a significant increase in adverse events between MLC901 and placebo, thus providing support for further studies on both efficacy and safety. Analyses suggest the potential of MLC901 in slowing down AD progression, but this requires further confirmation in larger and longer studies using biomarkers for AD.",2022,"There was no significant difference in the risk of SAEs between early and delayed starters at month (M) 6 (22.6% vs 27.0%, risk difference -4.4%, 90% CI -16.9% to 8.3%).","['Patients with mild to moderate probable AD by NINCDS-ADRDA criteria, stable on acetylcholinesterase inhibitors or memantine (n\xa0= 125', ""Alzheimer's Disease THErapy With NEuroaid (ATHENE"", ""Alzheimer's disease (AD"", '125 persons with dementia']","['MLC901', 'placebo', 'MLC901 and placebo', 'MLC901 (early starters) or placebo (delayed starters']","[""Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and other assessment scales"", 'risk of adverse events and the occurrence of stroke or vascular events', 'occurrence of serious adverse events (SAEs', 'adverse events', 'efficacy and safety', 'risk of SAEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0001046', 'cui_str': 'Acetylcholinesterase inhibitor'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2745174', 'cui_str': 'Neuroaid'}, {'cui': 'C1189272', 'cui_str': 'Athene'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C2931954', 'cui_str': 'MLC 901'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",125.0,0.90473,"There was no significant difference in the risk of SAEs between early and delayed starters at month (M) 6 (22.6% vs 27.0%, risk difference -4.4%, 90% CI -16.9% to 8.3%).","[{'ForeName': 'Christopher L H', 'Initials': 'CLH', 'LastName': 'Chen', 'Affiliation': 'Memory Ageing and Cognition Centre, National University Health System, Singapore; Departments of Pharmacology and Psychological Medicine, National University of Singapore, Singapore. Electronic address: phccclh@nus.edu.sg.'}, {'ForeName': 'Qingshu', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Singapore Clinical Research Institute, Singapore; Duke-National University of Singapore Medical School, Singapore.'}, {'ForeName': 'Rajesh Babu', 'Initials': 'RB', 'LastName': 'Moorakonda', 'Affiliation': 'Singapore Clinical Research Institute, Singapore.'}, {'ForeName': 'Nagaendran', 'Initials': 'N', 'LastName': 'Kandiah', 'Affiliation': 'Duke-National University of Singapore Medical School, Singapore; Department of Neurology, National Neuroscience Institute (TTSH Campus), Singapore; Lee Kong Chian School of Medicine, Singapore.'}, {'ForeName': 'Boon Yeow', 'Initials': 'BY', 'LastName': 'Tan', 'Affiliation': ""St. Luke's Hospital, Singapore.""}, {'ForeName': 'Steven Gayoles', 'Initials': 'SG', 'LastName': 'Villaraza', 'Affiliation': 'Memory Ageing and Cognition Centre, National University Health System, Singapore.'}, {'ForeName': 'Jemelle', 'Initials': 'J', 'LastName': 'Cano', 'Affiliation': 'Memory Ageing and Cognition Centre, National University Health System, Singapore.'}, {'ForeName': 'Narayanaswamy', 'Initials': 'N', 'LastName': 'Venketasubramanian', 'Affiliation': 'Raffles Neuroscience Centre, Raffles Hospital, Singapore.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2021.10.018']
2591,35219521,Intraoperative High Tidal Volume Ventilation and Postoperative Acute Respiratory Distress Syndrome in Liver Transplant.,"BACKGROUND


Mechanical ventilation plays an important role in perioperative management and patient outcomes. Although mechanical ventilation with high tidal volume (HTV) is injurious in patients in the intensive care unit, the effects of HTV ventilation in patients undergoing liver transplant (LT) has not been reported. The aim of this study was to determine if intraoperative HTV ventilation was associated with the development of acute respiratory distress syndrome (ARDS).
METHODS


Patients undergoing LT between 2013 and 2018 at a tertiary medical center were reviewed. The tidal volume was recorded at 3 time points: after anesthesia induction, before liver reperfusion, and at the end of surgery. Patients were divided into 2 groups: HTV (>10 mL/kg predicted body weight [pBW]) and non-HTV (≤10 mL/kg pBW). The 2 groups were compared. Independent risk factors were identified by multivariable logistic models.
RESULTS


Of 780 LT patients, 85 (10.9%) received HTV ventilation. Female sex and greater difference between actual body weight and pBW were independent risk factors for HTV ventilation. Patients who received HTV ventilation had a significantly higher incidence of ARDS (10.3% vs 3.9%; P = .01) than those who received non-HTV ventilation.
CONCLUSIONS


In this retrospective study, we showed that HTV ventilation during LT was common and was associated with a higher incidence of ARDS. Therefore, tidal volume should be carefully selected during LT surgery. More studies using a prospective randomized controlled design are needed.",2022,"Patients who received HTV ventilation had a significantly higher incidence of ARDS (10.3% vs 3.9%; P = .01) than those who received non-HTV ventilation.
","['acute respiratory distress syndrome (ARDS', 'Patients undergoing LT between 2013 and 2018 at a tertiary medical center were reviewed', 'patients undergoing liver transplant (LT', 'patients in the intensive care unit', 'and Postoperative Acute Respiratory Distress Syndrome in Liver Transplant']","['Intraoperative High Tidal Volume Ventilation', 'mechanical ventilation with high tidal volume (HTV', 'intraoperative HTV ventilation', 'HTV ventilation']","['tidal volume', 'incidence of ARDS', 'HTV ventilation']","[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",,0.0152518,"Patients who received HTV ventilation had a significantly higher incidence of ARDS (10.3% vs 3.9%; P = .01) than those who received non-HTV ventilation.
","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medicine, Yantaishan Hospital, Yantai, Shandong, P. R. China; Department of Anesthesiology and Perioperative Medicine, Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Hofer', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Nguyen-Buckley', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Disque', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wray', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Xia', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA. Electronic address: vxia@mednet.ucla.edu.'}]",Transplantation proceedings,['10.1016/j.transproceed.2021.10.030']
2592,35219462,COMPARATIVE ASSESSMENT OF NOVEL 3D PRINTED RESIN CROWNS VERSUS DIRECT CELLULOID CROWNS IN RESTORING PULP TREATED PRIMARY MOLARS.,"PURPOSE


The primary objective of this randomized controlled trial is to compare the clinical impact of using crowns manufactured by 3D printing and direct composite celluloid crowns as a final restoration for primary molars after pulpotomy procedures.
MATERIAL AND METHODS


Fifty primary molars selected from the children needing treatment at the Pediatric Dentistry Clinic at Damascus University Faculty of Dentistry were randomized by using SPSS and divided into 2 groups based on fabricating methods: Group A: 3D-printed crowns with the utilization of biocompatible light-curing composite, and Group B: Crowns were made directly using composite carried out by prefabricated celluloid crown. The evaluation team assessed the crowns in each group using the United States Public Health Service (USPHS) criteria for retention, marginal integrity, and gingival health at baseline, followed by 3 follow-up sessions at 3, 6, and 12 months.
RESULTS


Chi-Square statistical testing was accomplished using SPSS software to compare crown failure among the experimental group. At the 12-month follow-up, no statistically significant differences were noted between groups (P = .157). For gingival health assessment, the Mann-Whitney test was used. No statistically significant differences were recorded between the 2 groups in the third follow-up month (P = .058); However, a significant difference was noted in the 6th and 12th follow-up months (P = .023, P = .000). For marginal integrity comparison, Mann-Whitney statistical Test was used for the third, sixth, and twelfth-month follow-up sessions. A significant difference was noted in all follow-up periods (3-6-12 months) between the direct and indirect crowns (P = .025, P = .025, P = .002, respectively).
CONCLUSION


The 2 types of experimental crowns (direct composite celluloid crowns and the resin crowns manufactured via 3D printer) were suitable esthetic alternatives for restoring pulp-treated primary molars with a notably higher rate of retention with direct composite crowns. 3D-printed resin crowns, however, portrayed superior gingival health in addition to greater marginal integrity.",2022,"At the 12-month follow-up, no statistically significant differences were noted between groups (P = .157).","['Fifty primary molars selected from the children needing treatment at the Pediatric Dentistry Clinic at Damascus University Faculty of Dentistry were randomized by using SPSS and divided into 2 groups based on fabricating methods', 'primary molars after pulpotomy procedures']","['3D-printed crowns with the utilization of biocompatible light-curing composite, and Group B', 'crowns manufactured by 3D printing and direct composite celluloid crowns']","['United States Public Health Service (USPHS) criteria for retention, marginal integrity, and gingival health']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C1277300', 'cui_str': 'Child in need'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030763', 'cui_str': 'Pediatric dentistry'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C3849992', 'cui_str': 'Three-Dimensional Printing'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041734', 'cui_str': 'United States. Public Health Service'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",50.0,0.0358518,"At the 12-month follow-up, no statistically significant differences were noted between groups (P = .157).","[{'ForeName': 'Mohammed Nour', 'Initials': 'MN', 'LastName': 'Al-Halabi', 'Affiliation': 'Dental College, Damascus, University, Damascus, Syria.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Bshara', 'Affiliation': 'Dental College, Damascus, University, Damascus, Syria.'}, {'ForeName': 'Jihad Abou', 'Initials': 'JA', 'LastName': 'Nassar', 'Affiliation': 'Dental College, Damascus, University, Damascus, Syria.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Comisi', 'Affiliation': 'Medical University of South Carolina, James B. Edwards College of Dental Medicine, Charleston, SC, USA. Electronic address: comisi@musc.edu.'}, {'ForeName': 'Loulia', 'Initials': 'L', 'LastName': 'Alawa', 'Affiliation': 'Dental College, Damascus, University, Damascus, Syria.'}]",The journal of evidence-based dental practice,['10.1016/j.jebdp.2021.101664']
2593,35219449,"Evaluation of intraoperative ketamine on the prevention of severe rebound pain upon cessation of peripheral nerve block: a prospective randomised, double-blind, placebo-controlled study.","BACKGROUND


Pain after resolution of peripheral nerve block, known as 'rebound pain' (RP), is a major problem in outpatient surgery. The primary objective was to evaluate the benefit of intraoperative ketamine at an anti-hyperalgesic dose on the incidence of rebound pain after upper limb surgery under axillary plexus block in ambulatory patients. The secondary objective was to better understand the rebound pain phenomenon (individual risk factors).
METHODS


In this prospective, double-blind study, patients were randomised to receive either a single dose of i.v. ketamine (0.3 mg kg -1 ) or a placebo. Preoperative mechanical temporal summation and central sensitization inventory were applied to question underlying central sensitisation. Pain catastrophising and Douleur Neuropathique 4 questionnaires were used. Rebound pain was defined as pain intensity score >7 (numeric rating scale, 0-10) after block resolution. Postoperative pain was recorded at Days 1, 4, and 30 after discharge.
RESULTS


A total of 109 subjects completed the study, and 40.4% presented with rebound pain. Ketamine administration did not reduce rebound pain incidence or intensity. Temporal summation and central sensitisation inventory scores did not differ between subjects with and without rebound pain. The predictive risk factors were bone surgery (odds ratio [OR]=5.2; confidence interval [CI], 1.9-14.6), severe preoperative pain (OR=4.2; CI, 1.5-11.7), and high pain catastrophising (OR=4.8; CI, 1.0-22.3). At Day 30, the average daily pain was higher in the rebound pain group involving neuropathic characteristics.
CONCLUSION


Ketamine at an anti-hyperalgesic dose showed no benefit on rebound pain development. Although central sensitisation might not be involved, preoperative pain intensity, and catastrophising stand as risk factors. Because rebound pain remains frequent despite adequate procedure-specific postoperative analgesia, future studies should focus on patient-specific pain management.",2022,Temporal summation and central sensitisation inventory scores did not differ between subjects with and without rebound pain.,"['109 subjects completed the study, and 40.4% presented with rebound pain', 'severe rebound pain upon cessation of peripheral nerve block', 'after upper limb surgery under axillary plexus block in ambulatory patients', 'subjects with and without rebound pain']","['Ketamine', 'intraoperative ketamine', 'placebo', 'ketamine']","['Postoperative pain', 'severe preoperative pain', 'rebound pain phenomenon (individual risk factors', 'Rebound pain', 'rebound pain', 'Temporal summation and central sensitisation inventory scores', 'rebound pain development', 'pain intensity score', 'rebound pain incidence or intensity', 'high pain catastrophising', 'average daily pain']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0584885', 'cui_str': 'Local anesthetic block of nerve plexus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",109.0,0.263332,Temporal summation and central sensitisation inventory scores did not differ between subjects with and without rebound pain.,"[{'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Touil', 'Affiliation': 'Department of Anaesthesiology, Cliniques Universitaires St Luc, University Catholic of Louvain, Brussels, Belgium. Electronic address: nassim.touil@saintluc.uclouvain.be.'}, {'ForeName': 'Athanasia', 'Initials': 'A', 'LastName': 'Pavlopoulou', 'Affiliation': 'Department of Anaesthesiology, Cliniques Universitaires St Luc, University Catholic of Louvain, Brussels, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Barbier', 'Affiliation': 'Department of Orthopaedic Surgery, Cliniques Universitaires St Luc, University Catholic of Louvain, Brussels, Belgium.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Libouton', 'Affiliation': 'Department of Orthopaedic Surgery, Cliniques Universitaires St Luc, University Catholic of Louvain, Brussels, Belgium.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': ""Lavand'homme"", 'Affiliation': 'Department of Anaesthesiology, Cliniques Universitaires St Luc, University Catholic of Louvain, Brussels, Belgium.'}]",British journal of anaesthesia,['10.1016/j.bja.2021.11.043']
2594,35219715,Augmented Wide Area Circumferential Catheter Ablation for Reduction of Atrial Fibrillation Recurrence (AWARE) Trial: Design and Rationale.,"BACKGROUND


Recurrence of atrial fibrillation (AF) after a pulmonary vein isolation procedure is often due to electrical reconnection of the pulmonary veins. Repeat ablation procedures may improve freedom from AF but are associated with increased risks and health care costs. A novel ablation strategy in which patients receive ""augmented"" ablation lesions has the potential to reduce the risk of AF recurrence.
METHODS


The Augmented Wide Area Circumferential Catheter Ablation for Reduction of Atrial Fibrillation Recurrence (AWARE) Trial was designed to evaluate whether an augmented wide-area circumferential antral (WACA) ablation strategy will result in fewer atrial arrhythmia recurrences in patients with symptomatic paroxysmal AF, compared with a conventional WACA strategy.
RESULTS


The AWARE trial was a multicenter, prospective, randomized, open, blinded endpoint trial that has completed recruitment (ClinicalTrials.gov NCT02150902). Patients were randomly assigned (1:1) to either the control arm (single WACAlesion set) or the interventional arm (augmented- double WACA lesion set performed after the initial WACA). The primary outcome was atrial tachyarrhythmia (AA; atrial tachycardia [AT], atrial flutter [AFl] or AF) recurrence between days 91 and 365 post catheter ablation. Patient follow-up included 14-day continuous ambulatory ECG monitoring at 3, 6 and 12 months after catheter ablation. Three questionnaires were administered during the trial- the EuroQuol-5D (EQ-5D) quality of life scale, the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale and a patient satisfaction scale.
CONCLUSIONS


The AWARE trial was designed to evaluate whether a novel approach to catheter ablation reduced the risk of AA recurrence in patients with symptomatic paroxysmal AF.",2022,The Augmented Wide Area Circumferential Catheter Ablation for Reduction of Atrial Fibrillation Recurrence (AWARE),['patients with symptomatic paroxysmal AF'],"['novel approach to catheter ablation', 'control arm (single WACAlesion set) or the interventional arm (augmented- double WACA lesion set performed after the initial WACA', 'augmented wide-area circumferential antral (WACA) ablation strategy', 'Augmented Wide Area Circumferential Catheter Ablation']","['atrial tachyarrhythmia (AA; atrial tachycardia [AT], atrial flutter [AFl] or AF) recurrence', 'EuroQuol-5D (EQ-5D) quality of life scale, the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale and a patient satisfaction scale', 'Atrial Fibrillation Recurrence (AWARE', 'risk of AA recurrence', 'atrial arrhythmia recurrences']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia'}]",,0.067112,The Augmented Wide Area Circumferential Catheter Ablation for Reduction of Atrial Fibrillation Recurrence (AWARE),"[{'ForeName': 'Girish M', 'Initials': 'GM', 'LastName': 'Nair', 'Affiliation': 'University of Ottawa Heart Institute, Canada. Electronic address: gnair@ottawaheart.ca.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Birnie', 'Affiliation': 'University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Wells', 'Affiliation': 'University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Pablo B', 'Initials': 'PB', 'LastName': 'Nery', 'Affiliation': 'University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Calum J', 'Initials': 'CJ', 'LastName': 'Redpath', 'Affiliation': 'University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Sarrazin', 'Affiliation': 'IUCPQ, Quebec, Quebec, Canada.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Roux', 'Affiliation': 'CHUS-Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Ratika', 'Initials': 'R', 'LastName': 'Parkash', 'Affiliation': 'Queen Elizabeth II Health Sciences, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bernier', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Laurence D', 'Initials': 'LD', 'LastName': 'Sterns', 'Affiliation': 'Victoria Cardiac Arrhythmia Trials, Victoria, British Columbia, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': 'Victoria Cardiac Arrhythmia Trials, Victoria, British Columbia, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Veenhuyzen', 'Affiliation': 'Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Morillo', 'Affiliation': 'Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Sheldon M', 'Initials': 'SM', 'LastName': 'Singh', 'Affiliation': 'Sunnybrook Health Sciences Center, Toronto, Ontario, Canada.'}, {'ForeName': 'Marcio', 'Initials': 'M', 'LastName': 'Sturmer', 'Affiliation': 'Hôpital Sacré-Cœur de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Vijay S', 'Initials': 'VS', 'LastName': 'Chauhan', 'Affiliation': 'University Health Network, Toronto General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Angaran', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Vidal', 'Initials': 'V', 'LastName': 'Essebag', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada; Hôpital Sacré-Cœur de Montréal, Montréal, Québec, Canada.'}]",American heart journal,['10.1016/j.ahj.2022.02.009']
2595,35219633,An implementation and effectiveness study evaluating Conflict Analysis in VA residential substance abuse services: Whole Health informed self-guided online care.,"CONTEXT


Whole Health is an emerging healthcare framework that emphasizes wellbeing in place of illness. Conflict Analysis (CA), an online self-guided assessment, leverages innovative diagnostic and therapeutic resources that shares Whole Health objectives, including helping users explore their identity and develop a personalized health plan and helping users develop resources to optimize their health.
OBJECTIVES


Paper presents CA implementation-effectiveness study in a Veteran Affairs inpatient substance recovery care.
DESIGN


Patients were randomized to CA or mindfulness control. Patients completed Whole Health outcomes measures at baseline, completion (post), and three-week follow-up. Interventions took 2.5 h. Attending psychologist assessed CA protocols and completed outcome evaluation. Due to Coronavirus, recruitment and follow-up were curtailed.
SETTING


Study took place in a rural northern New England Veteran Affairs inpatient substance recovery unit.
OUTCOME MEASURES


Measures include The Personal Growth Initiative Scale, The Beck Cognitive Insight Scale, Perceived Stress Scale, The Patient Health Questionnaire, Perceived Psychological Wellbeing, and Perceived Therapeutic and Diagnostic Benefit.
RESULTS


12 patients were randomized, 11 completed post measures (CA=5; Mindfulness = 6), and 7 completed follow-up measures (CA=3; Mindfulness=4). CA offered significant Whole Health benefits when compared to control. Additionally, participant and clinician evaluations indicated that CA can be personally relevant, meaningful, and motivate therapeutic growth. Implications include extending CA research and expanding Whole Health related interventions. Although initial results suggest implementation feasibility and Whole Health benefit, more research is necessary to establish CA's utility within inpatient substance recovery care in particular and psychiatric rehabilitation in general.",2022,CA offered significant Whole Health benefits when compared to control.,"['VA residential substance abuse services', '12 patients', 'Study took place in a rural northern New England Veteran Affairs inpatient substance recovery unit']",['CA or mindfulness control'],"['Personal Growth Initiative Scale, The Beck Cognitive Insight Scale, Perceived Stress Scale, The Patient Health Questionnaire, Perceived Psychological Wellbeing, and Perceived Therapeutic and Diagnostic Benefit']","[{'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0027965', 'cui_str': 'Northeastern United States'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C4075638', 'cui_str': 'Recovery unit'}]","[{'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",12.0,0.0461139,CA offered significant Whole Health benefits when compared to control.,"[{'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Levis', 'Affiliation': 'Veterans Affairs Medical Center, White River Junction, VT, United States of America; Department of Psychiatry, Geisel School of Medicine, Hanover, NH, United States of America. Electronic address: Maxwell.e.levis@dartmouth.edu.'}, {'ForeName': 'Dana J', 'Initials': 'DJ', 'LastName': 'Ludmer', 'Affiliation': 'Clinical Psychology, Antioch University of New England, Keene NH, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cornelius', 'Affiliation': 'Veterans Affairs Medical Center, White River Junction, VT, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scott', 'Affiliation': 'Veterans Affairs Medical Center, White River Junction, VT, United States of America.'}, {'ForeName': 'Bradley V', 'Initials': 'BV', 'LastName': 'Watts', 'Affiliation': 'Veterans Affairs Medical Center, White River Junction, VT, United States of America; Department of Psychiatry, Geisel School of Medicine, Hanover, NH, United States of America; VA Office of Systems Redesign and Improvement, 215 North Main Street, White River Junction, VT 05009, United States of America.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Shiner', 'Affiliation': 'Veterans Affairs Medical Center, White River Junction, VT, United States of America; Department of Psychiatry, Geisel School of Medicine, Hanover, NH, United States of America; National Center for PTSD, 215 North Main Street, White River Junction, VT\xa0 05009, USA.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2022.02.005']
2596,35219565,Patient-reported aesthetic outcomes of upper blepharoplasty: a randomized controlled trial comparing two surgical techniques.,"It is not yet established whether additional orbicularis oculi muscle excision leads to better patient-reported aesthetic outcomes (PRO) compared to a skin-only resection blepharoplasty. A double-blind randomized controlled trial of upper blepharoplasty, with or without muscle excision, was performed on 54 White European patients who assessed the procedure via PRO. FACE-Q questionnaires covering eyes in general, upper eyelids, forehead and eyebrows, overall face, age appearance appraisal, age appraisal, social functioning, satisfaction with the outcome, and adverse effects were completed preoperatively and at 6 and 12 months after upper blepharoplasty. The Patient and Observer Scar Assessment Scale was used to assess scarring. The FACE-Q scores for skin-only and skin/muscle upper blepharoplasty were similar regarding the upper eyelids, forehead and eyebrows, overall face, patient perceived aging and age, social functioning, and satisfaction with the results, and also increased for both procedures with time. The FACE-Q score regarding the eyes in general was higher in the skin-only group at the 12-month follow-up. Scarring and adverse effects did not differ between the groups. Additional muscle resection does not seem to influence patient satisfaction. Thus, when performing an upper blepharoplasty, there is no need for additional muscle resection as a routine procedure to improve patient satisfaction.",2022,The FACE-Q score regarding the eyes in general was higher in the skin-only group at the 12-month follow-up.,['54 White European patients who assessed the procedure via PRO'],"['upper blepharoplasty, with or without muscle excision']","['Scarring and adverse effects', 'FACE-Q questionnaires covering eyes in general, upper eyelids, forehead and eyebrows, overall face, age appearance appraisal, age appraisal, social functioning, satisfaction with the outcome, and adverse effects', 'Patient and Observer Scar Assessment Scale', 'aesthetic outcomes']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0197213', 'cui_str': 'Repair of eyelid'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0455242', 'cui_str': 'Covering eye'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0585636', 'cui_str': 'Upper eyelid structure'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0015420', 'cui_str': 'Eyebrow structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}]",54.0,0.148192,The FACE-Q score regarding the eyes in general was higher in the skin-only group at the 12-month follow-up.,"[{'ForeName': 'M H J', 'Initials': 'MHJ', 'LastName': 'Hollander', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen and University Medical Center Groningen (UMCG), Groningen, The Netherlands. Electronic address: m.h.j.hollander@umcg.nl.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Delli', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen and University Medical Center Groningen (UMCG), Groningen, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vissink', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen and University Medical Center Groningen (UMCG), Groningen, The Netherlands.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Schepers', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen and University Medical Center Groningen (UMCG), Groningen, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jansma', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen and University Medical Center Groningen (UMCG), Groningen, The Netherlands.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2022.02.007']
2597,35219526,A randomized trial of topical mitomycin-C in the immediate post-operative period for the short and long-term prevention of granulation tissue in mastoid cavities.,"BACKGROUND


Granulation tissue is a primary source of otorrhea in the ear, particularly after surgery, and may develop complications in patients. Hence, discovering an efficient treatment is crucial for this disorder.
PURPOSE


This study aimed to evaluate the mitomycin drops efficacy for germination prevention during the recovery process after mastoidectomy. Our purpose was to introduce novel treatment options in some conditions in which we could not reconstitute the cavity to prevent the possible germination.
MATERIALS AND METHODS


This clinical trial was performed on 52 patients undergoing mastoidectomy. Patients were randomly divided into two groups (26 patients in the mitomycin group and 26 patients in the placebo group). After drug administration, the granulation tissue and complications were recorded. All statistical analysis was performed using SPSS version 21.
RESULTS


The results of our study showed that mitomycin administration in patients undergoing mastoidectomy significantly reduced the formation of the granulation tissue in the first and third months after surgery (P < 0.05), which is associated with increased patient satisfaction (P < 0.05).
CONCLUSION


The germ formation after mastoidectomy is so common. Since mitomycin administration decreased the incidence of germ formation, it can be proposed as a suggestive treatment in all patients to increase surgical quality and decrease complications include granulation formation.",2022,"The results of our study showed that mitomycin administration in patients undergoing mastoidectomy significantly reduced the formation of the granulation tissue in the first and third months after surgery (P < 0.05), which is associated with increased patient satisfaction (P < 0.05).
","['52 patients undergoing mastoidectomy', 'mastoid cavities']","['topical mitomycin-C', 'mitomycin', 'placebo']","['formation of the granulation tissue', 'patient satisfaction', 'granulation tissue and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0198154', 'cui_str': 'Mastoidectomy'}, {'cui': 'C1688623', 'cui_str': 'Mastoid cavity'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",52.0,0.0735102,"The results of our study showed that mitomycin administration in patients undergoing mastoidectomy significantly reduced the formation of the granulation tissue in the first and third months after surgery (P < 0.05), which is associated with increased patient satisfaction (P < 0.05).
","[{'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Ghobadi', 'Affiliation': 'Clinical Research Development Center, Ghods Hospital, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Mehraveh', 'Initials': 'M', 'LastName': 'Sadeghi Ivraghi', 'Affiliation': 'Department of Medicine, School of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Yazdi', 'Affiliation': 'Occupational Medicine Specialist, Metabolic Disease Research Center, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Keshavarz Shahbaz', 'Affiliation': 'Cellular and Molecular Research Center, Research Institute for Prevention of Non-communicable Disease, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: Sanaz.ks_023@yahoo.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2022.103396']
2598,35223743,Twelve-Week Game-Based School Intervention Improves Physical Fitness in 12-14-Year-Old Girls.,"The aim of this study was to determine the effects of a twelve-week game-based school intervention on physical fitness in girls aged 12-14 years. Fifty-nine adolescent girls (13.2 ± 0.3 years) were randomly assigned to a group that participated in a game-based after-school program (EXP) or a control group (CON) that participated only in mandatory physical education. The EXP group had the additional program twice a week after school for 40 min/session for 12 weeks alongside with regular physical education classes. The EXP program consisted mainly of small-sided games of football, basketball, handball, and volleyball. The assessment included a physical fitness assessment with standardized tests for this age group: countermovement jump (CMJ), standing long jump, bent arm hang, overhead medicine ball throw, sit-ups for 30 s, and Yo-Yo Intermittent Recovery Level 1 Test (YYIRT1). There was a significant interaction between group (EXP vs. CON) and time (pre-test vs. post-test) for the standing long jump ( p  < 0.001), overhead medicine ball throw ( p  < 0.001), 30 s sit-ups ( p  = 0.030), bent- arm hang ( p  < 0.001), and YYIRT1 score ( p  = 0.004). In addition, a significant main effect was found for time in countermovement jump ( p  < 0.001). The results of this study indicate that the after-school game-based intervention significantly improves adolescent girls' physical fitness compared to regular physical education. The overall conclusion suggests that as few as two additional sessions per week are sufficient to produce significant changes in physical fitness in adolescent girls.",2022,"In addition, a significant main effect was found for time in countermovement jump ( p  < 0.001).","['adolescent girls', 'girls aged 12-14 years', 'Fifty-nine adolescent girls (13.2 ± 0.3 years', '12-14-Year-Old Girls']","['game-based after-school program (EXP) or a control group (CON) that participated only in mandatory physical education', 'twelve-week game-based school intervention', 'countermovement jump (CMJ), standing long jump, bent arm hang, overhead medicine ball throw, sit-ups for 30 s, and Yo-Yo Intermittent Recovery Level 1 Test (YYIRT1', 'Twelve-Week Game-Based School Intervention']","[""adolescent girls' physical fitness"", 'Physical Fitness', 'YYIRT1 score', 'physical fitness', 'time in countermovement jump']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0544691', 'cui_str': 'Hanging'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0560837', 'cui_str': 'Does sit up'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",59.0,0.0190448,"In addition, a significant main effect was found for time in countermovement jump ( p  < 0.001).","[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Petrušič', 'Affiliation': 'Faculty of Education, University of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Trajković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Niš, Niš, Serbia.'}, {'ForeName': 'Špela', 'Initials': 'Š', 'LastName': 'Bogataj', 'Affiliation': 'University Medical Centre, Department of Nephrology, Ljubljana, Slovenia.'}]",Frontiers in public health,['10.3389/fpubh.2022.831424']
2599,35223726,Impact of Refutational Two-Sided Messages on Attitudes Toward Novel Vaccines Against Emerging Infectious Diseases During the COVID-19 Pandemic.,"Two-sided messages that include two perspectives (i.e., risks and benefits) are more effective than one-sided messages that convey only one perspective (usually only the benefits). Refutational two-sided messages are effective for communicating risks regarding vaccines. To examine the effectiveness of refutational two-sided messages in risk communication regarding novel vaccines against emerging infectious diseases, we conducted the randomized controlled study based on a 3 × 3 × 2 mixed design (Intervention 1: vaccines against subcutaneous influenza, ""novel severe infectious disease,"" or intranasal influenza; intervention 2: one-sided, non-refutational two-sided, or refutational two-sided messages; two questionnaires) using a Japanese online panel. Participants completed questionnaires before and after receiving an attack message (negative information). We evaluated the impact of attack messages on the willingness to be vaccinated, and the anticipated regret of inaction (ARI). Among 1,184 participants, there was a significant difference in the willingness to be vaccinated among the message groups ( p  < 0.01). After receiving the attack message, willingness to be vaccinated decreased in the one-sided message group and increased in the non-refutational two-sided and refutational two-sided message groups. Additionally, ARI in the refutational two-sided message groups was significantly higher than in the one-sided groups ( p  = 0.03). In conclusion, two-sided messages are more effective than one-sided messages in terms of willingness to be vaccinated. Furthermore, the high ARI in the refutational two-sided message group indicated that refutational two-sided messages were more effective than one-sided messages for communicating the risks of vaccines, especially those against emerging infectious diseases.",2022,"To examine the effectiveness of refutational two-sided messages in risk communication regarding novel vaccines against emerging infectious diseases, we conducted the randomized controlled study based on a 3 × 3 × 2 mixed design (Intervention 1: vaccines against subcutaneous influenza, ""novel severe infectious disease,"" or intranasal influenza; intervention 2: one-sided, non-refutational two-sided, or refutational two-sided messages; two questionnaires) using a Japanese online panel.",[],"['vaccines against subcutaneous influenza, ""novel severe infectious disease,"" or intranasal influenza; intervention 2: one-sided, non-refutational two-sided, or refutational two-sided messages; two questionnaires) using a Japanese online panel', 'Refutational Two-Sided Messages']",['Attitudes'],[],"[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}]",1184.0,0.03137,"To examine the effectiveness of refutational two-sided messages in risk communication regarding novel vaccines against emerging infectious diseases, we conducted the randomized controlled study based on a 3 × 3 × 2 mixed design (Intervention 1: vaccines against subcutaneous influenza, ""novel severe infectious disease,"" or intranasal influenza; intervention 2: one-sided, non-refutational two-sided, or refutational two-sided messages; two questionnaires) using a Japanese online panel.","[{'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Okuno', 'Affiliation': 'Center for Surveillance, Immunization, and Epidemiologic Research, National Institute of Infectious Diseases, Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Arai', 'Affiliation': 'Center for Surveillance, Immunization, and Epidemiologic Research, National Institute of Infectious Diseases, Tokyo, Japan.'}, {'ForeName': 'Motoi', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Center for Surveillance, Immunization, and Epidemiologic Research, National Institute of Infectious Diseases, Tokyo, Japan.'}, {'ForeName': 'Toshiko', 'Initials': 'T', 'LastName': 'Kikkawa', 'Affiliation': 'Faculty of Business and Commerce, Keio University, Tokyo, Japan.'}]",Frontiers in public health,['10.3389/fpubh.2022.775486']
2600,35223713,Effects of Combing Group Executive Functioning and Online Parent Training on School-Aged Children With ADHD: A Randomized Controlled Trial.,"Objective


The acceptance of drug treatment for younger children with attention-deficit/hyperactivity disorder (ADHD) in China remains low. Here, we explored the clinical benefits of a non-pharmaceutical intervention method combining a group and executive function training and an online parent training program, termed group executive functioning and online parent training (GEF-OPT), for school-aged students with ADHD through a randomized controlled trial.
Method


A total of 145 children (aged 6-8 years) were formally registered and randomized to the intervention group ( n  = 73) and waitlist group ( n  = 72). The enrolled children received eight sessions of GEF-OPT treatment, which consists of a hospital-based children executive function (EF) training program and an online parent training program. Treatment outcome was assessed by a parent/teacher report questionnaire and neurophysiological experiment.
Results


After eight sessions of intervention, children in the intervention group showed a significant improvement in inattentive symptom compared to the waitlist group (14.70 ± 4.35 vs. 16.03 ± 2.93;  p  = 0.024), but an insignificant difference in hyperactive-impulsivity (9.85 ± 5.30 vs. 10.69 ± 5.10;  p  = 0.913). Comorbid oppositional defiant disorder was significantly reduced in the intervention group (7.03 ± 4.39 vs. 8.53 ± 4.41;  p  = 0.035). Children in the intervention group had greater reduction in the scores of behavioral regulation index (inhibition, emotional control) and metacognition index (working memory, planning/organization, monitoring) in executive function than those in the waitlist group ( p  < 0.05). Significant effects were also found in learning problem of Weiss Functional Impairment Scale-Parent form and parental distress between two groups at post-treatment ( p  < 0.05). In line with this, the result of go/no-go task showed significant improvements in accuracy change (4.45 ± 5.50% vs. 1.76 ± 3.35%;  p  = 0.001) and reaction time change (47.45 ± 62.25 s vs. 16.19 ± 72.22 s;  p  = 0.007) in the intervention group compared with the waitlist group.
Conclusion


We conclude that participants in the GEF-OPT program improved outcomes for inattentive symptom, executive function, learning problems, and parental distress. GEF-OPT is a promising non-pharmaceutical therapeutic option for younger children.
Trial Registration


ChiCTR2100052803.",2021,"Children in the intervention group had greater reduction in the scores of behavioral regulation index (inhibition, emotional control) and metacognition index (working memory, planning/organization, monitoring) in executive function than those in the waitlist group ( p  < 0.05).","['School-Aged Children With ADHD', 'younger children with attention-deficit/hyperactivity disorder (ADHD', '145 children (aged 6-8 years', 'younger children', 'school-aged students with ADHD']","['GEF-OPT program', 'non-pharmaceutical intervention method combining a group and executive function training and an online parent training program, termed group executive functioning and online parent training (GEF-OPT', 'GEF-OPT treatment, which consists of a hospital-based children executive function (EF) training program and an online parent training program', 'Combing Group Executive Functioning and Online Parent Training', 'GEF-OPT']","['scores of behavioral regulation index (inhibition, emotional control) and metacognition index (working memory, planning/organization, monitoring) in executive function', 'inattentive symptom', 'inattentive symptom, executive function, learning problems, and parental distress', 'accuracy change', 'parent/teacher report questionnaire and neurophysiological experiment', 'reaction time change', 'hyperactive-impulsivity', 'Comorbid oppositional defiant disorder', 'learning problem of Weiss Functional Impairment Scale-Parent form and parental distress']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0589092', 'cui_str': 'Executive functions training'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376161', 'cui_str': 'Comb'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",145.0,0.013914,"Children in the intervention group had greater reduction in the scores of behavioral regulation index (inhibition, emotional control) and metacognition index (working memory, planning/organization, monitoring) in executive function than those in the waitlist group ( p  < 0.05).","[{'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Chu', 'Affiliation': ""Department of Child Health Care, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Peiying', 'Initials': 'P', 'LastName': 'Zhu', 'Affiliation': ""Department of Child Health Care, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Chenhuan', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': ""Department of Child Health Care, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Lizhu', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': ""Department of Child Health Care, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ""Clinical Research Center, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Danmai', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Child Health Care, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Child Health Care, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Guangjun', 'Initials': 'G', 'LastName': 'Yu', 'Affiliation': ""Department of Child Health Care, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}]",Frontiers in pediatrics,['10.3389/fped.2021.813305']
2601,35223664,Protectivity and safety following recombinant hepatitis B vaccine with different source of bulk compared to hepatitis B (Bio Farma) vaccine in Indonesia.,"Purpose


Indonesia, a high populous and the second-highest country in epidemicity of hepatitis B in South-East Asia require maintaining its capacity of monovalent hepatitis B production to keep up with both the national immunization program and global needs. To keep the sustainability of the vaccine, a new bulk is needed to be made available. This study aims to evaluate the immunogenicity and safety of Bio Farma newly formulated recombinant hepatitis B vaccines, which came from different sources of bulk, compared to the already registered hepatitis B vaccine.
Materials and Methods


An experimental, randomized, double-blind, cohort intervention phase II clinical trial was conducted on three recombinant hepatitis B vaccines from different bulk sources, with Bio Farma registered hepatitis B vaccine as the control group. A total of 536 participants around age 10 to 40 years old were thricely vaccinated with twice serological assessments. The subject's safety was monitored for 28 days after each vaccination.
Results


Of 536 enrolled participants, 521 finished the vaccination and serology assessments. The investigational products were proven not to be inferior to the control. All vaccines were well tolerated. No differences in rates of local and systemic reactions were seen between the investigational products and control. No serious adverse event was found to be related to the investigational vaccines.
Conclusion


Investigational vaccines are shown to be equally immunogenic and safe as the control vaccine.",2022,No differences in rates of local and systemic reactions were seen between the investigational products and control.,"['Indonesia', '536 enrolled participants, 521 finished the vaccination and serology assessments', '536 participants around age 10 to 40 years old were thricely vaccinated with twice serological assessments']","['recombinant hepatitis B vaccine', 'hepatitis B (Bio Farma) vaccine', 'Bio Farma newly formulated recombinant hepatitis B vaccines']","['Protectivity and safety', 'rates of local and systemic reactions', 'immunogenicity and safety', 'tolerated']","[{'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}]","[{'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",536.0,0.23761,No differences in rates of local and systemic reactions were seen between the investigational products and control.,"[{'ForeName': 'Yetty M', 'Initials': 'YM', 'LastName': 'Nency', 'Affiliation': 'Faculty of Medicine, University of Diponegoro, Semarang, Indonesia.'}, {'ForeName': 'Farid Agung', 'Initials': 'FA', 'LastName': 'Rahmadi', 'Affiliation': 'Faculty of Medicine, University of Diponegoro, Semarang, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Mulyono', 'Affiliation': 'Faculty of Medicine, University of Diponegoro, Semarang, Indonesia.'}, {'ForeName': 'Dimas Tri', 'Initials': 'DT', 'LastName': 'Anantyo', 'Affiliation': 'Faculty of Medicine, University of Diponegoro, Semarang, Indonesia.'}, {'ForeName': 'Nur', 'Initials': 'N', 'LastName': 'Farhanah', 'Affiliation': 'Faculty of Medicine, University of Diponegoro, Semarang, Indonesia.'}, {'ForeName': 'Rebriarina', 'Initials': 'R', 'LastName': 'Hapsari', 'Affiliation': 'Faculty of Medicine, University of Diponegoro, Semarang, Indonesia.'}, {'ForeName': 'Helmia', 'Initials': 'H', 'LastName': 'Farida', 'Affiliation': 'Faculty of Medicine, University of Diponegoro, Semarang, Indonesia.'}, {'ForeName': 'Udadi', 'Initials': 'U', 'LastName': 'Sadhana', 'Affiliation': 'Faculty of Medicine, University of Diponegoro, Semarang, Indonesia.'}, {'ForeName': 'Herry', 'Initials': 'H', 'LastName': 'Djagat', 'Affiliation': 'Faculty of Medicine, University of Diponegoro, Semarang, Indonesia.'}, {'ForeName': 'Tri Nur', 'Initials': 'TN', 'LastName': 'Kristina', 'Affiliation': 'Faculty of Medicine, University of Diponegoro, Semarang, Indonesia.'}, {'ForeName': 'Achmad Zulfa', 'Initials': 'AZ', 'LastName': 'Juniarto', 'Affiliation': 'Faculty of Medicine, University of Diponegoro, Semarang, Indonesia.'}, {'ForeName': 'Mita', 'Initials': 'M', 'LastName': 'Puspita', 'Affiliation': 'PT Bio Farma, Bandung, Indonesia.'}, {'ForeName': 'Rini Mulia', 'Initials': 'RM', 'LastName': 'Sari', 'Affiliation': 'PT Bio Farma, Bandung, Indonesia.'}, {'ForeName': 'Novilia Sjafri', 'Initials': 'NS', 'LastName': 'Bachtiar', 'Affiliation': 'PT Bio Farma, Bandung, Indonesia.'}]",Clinical and experimental vaccine research,['10.7774/cevr.2022.11.1.43']
2602,35223654,A Comparative Double Blind Study of Nasal Dressing Sponge ®  versus Merocel ®  as Nasal Pack after Nasal Surgery.,"Introduction


Nasal packing is a common procedure used to ensure haemostasis after nasal surgery.
Materials and Methods


A prospective, randomized, controlled and double-blinded study was conducted on 80 consecutive subjects to investigate whether using Nasal Dressing Sponge® (NDS) instead of simple Merocel® might improve patients' postoperative experience of nasal packing.
Results


During the stay of the tampons no differences were noticed between the two groups as regards the postoperative pain. When it comes to pain during the packing removal, patients complained of worse symptoms in the side packed with Merocel. There was no bleeding after the removal of Merocel, whereas 5,6% patients were subject to some bleeding when NDS was removed.
Conclusion


Merocel and NDS gave similar results regarding haemostatic activity. Nasal Dressing Sponge could decrease pain during the removal of the nasal pack, while it could be associated to a bigger incidence of mild bleeding after removing the pack.",2021,During the stay of the tampons no differences were noticed between the two groups as regards the postoperative pain.,"['80 consecutive subjects', 'as Nasal Pack after Nasal Surgery']","['Nasal Dressing Sponge® (NDS', 'Nasal Dressing Sponge', 'Nasal Dressing Sponge ®  versus Merocel ®']","['pain', 'haemostatic activity', 'postoperative pain']","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0188970', 'cui_str': 'Operation on nose'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0032699', 'cui_str': 'Phylum Porifera'}, {'cui': 'C0127601', 'cui_str': 'Merocel'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",80.0,0.0501747,During the stay of the tampons no differences were noticed between the two groups as regards the postoperative pain.,"[{'ForeName': 'Lorusso', 'Initials': 'L', 'LastName': 'Francesco', 'Affiliation': 'Otolaryngology Unit, Department of Biomedicine and Advanced Diagnostic-University of Palermo, Palermo, Italy.'}, {'ForeName': 'Dispenza', 'Initials': 'D', 'LastName': 'Francesco', 'Affiliation': 'Otolaryngology Unit, Department of Biomedicine and Advanced Diagnostic-University of Palermo, Palermo, Italy.'}, {'ForeName': 'Sireci', 'Initials': 'S', 'LastName': 'Federico', 'Affiliation': 'Otolaryngology Unit, Department of Biomedicine and Advanced Diagnostic-University of Palermo, Palermo, Italy.'}, {'ForeName': 'Modica-Domenico', 'Initials': 'MD', 'LastName': 'Michele', 'Affiliation': 'Otolaryngology Unit, Department of Biomedicine and Advanced Diagnostic-University of Palermo, Palermo, Italy.'}, {'ForeName': 'Gallina', 'Initials': 'G', 'LastName': 'Salvatore', 'Affiliation': 'Otolaryngology Unit, Department of Biomedicine and Advanced Diagnostic-University of Palermo, Palermo, Italy.'}]",Iranian journal of otorhinolaryngology,['10.22038/IJORL.2021.49606.2649']
2603,35220330,Efficacy and Safety of a New Sustained-released Pregabalin Formulation Compared with Immediate-release Pregabalin in Patients with Peripheral Neuropathic Pain: A Randomized Non-inferiority Phase 3 Trial.,"OBJECTIVES


This study investigated whether a new sustained-release (SR) pregabalin formulation is non-inferior to immediate-release (IR) pregabalin in alleviating peripheral neuropathic pain in Korean patients.
METHODS


This was a randomized, double-blind, active-controlled phase 3 study of patients with diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN) from 41 sites in South Korea in 2017-2018. Eligible patients were randomized (1:1) to receive once-daily SR pregabalin or twice-daily IR pregabalin (150-600▒mg/d) in a double-dummy manner for 12 weeks according to a stratified permuted block randomization scheme. The primary endpoint was the daily pain rating scale (DPRS) score at the end of treatment, averaged from the last seven available scores.
RESULTS


A total of 319 of 371 (86.0%) randomized patients completed the 12-week treatment (SR pregabalin: n=154; IR pregabalin: n=165; per protocol set: n=296). The least square (LS) mean difference between both groups for the primary endpoint was 0.06 (SE 0.19); (95% CI -0.31 to 0.42), with the lower limit of the CI above the pre-specified margin (-0.78; P-value for non-inferiority <0.0001). Drug-related treatment-emergent adverse events (TEAEs) were comparable between both groups. The incidence of drug-related TEAEs leading to treatment discontinuation was low (SR pregabalin: 2.7%; IR pregabalin: 1.1%). No serious drug-related TEAEs or deaths occurred.
DISCUSSION


The results demonstrate that the new once-daily SR pregabalin formulation is non-inferior to twice-daily IR pregabalin in reducing peripheral neuropathic pain, and is well tolerated in Korean patients with DPN or PHN after 12 weeks of treatment. Trial registration: ClinicalTrials.gov (identifier NCT02985216).",2022,"No serious drug-related TEAEs or deaths occurred.
","['Korean patients with DPN', 'Korean patients', 'Eligible patients', 'Patients with Peripheral Neuropathic Pain', 'patients with diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN) from 41 sites in South Korea in 2017-2018', 'A total of 319 of 371 (86.0%) randomized patients completed the']","['new sustained-release (SR) pregabalin formulation', 'New Sustained-released Pregabalin Formulation', 'Immediate-release Pregabalin', '12-week treatment (SR pregabalin: n=154; IR pregabalin', 'daily SR pregabalin or twice-daily IR pregabalin']","['daily pain rating scale (DPRS) score', 'peripheral neuropathic pain', 'Efficacy and Safety']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0458960', 'cui_str': 'Peripheral neuropathic pain'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0458960', 'cui_str': 'Peripheral neuropathic pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.11236,"No serious drug-related TEAEs or deaths occurred.
","[{'ForeName': 'Kyung Ah', 'Initials': 'KA', 'LastName': 'Han', 'Affiliation': ""Nowon Eulji Medical Center, Eulji University, Seoul, Republic of Korea Yonsei University Severnace Hospital, Seoul, Republic of Korea The Catholic University of Korea Uijeongbu St. Mary's Hospital, Uijeongbu, Republic of Korea The Catholic University of Korea Yeouido St. Mary's Hospital, Seoul, Republic of Korea Chosun University, School of Medicine, Gwangju, Republic of Korea Yonsei University Wonju Severance Christian Hospital, Wonju, Republic of Korea Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea Ajou University School of Medicine, Suwon, Republic of Korea Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea Konkuk University Hospital, Seoul, Republic of Korea Chungnam National University Hospital, Daejeon, Republic of Korea Chung-Ang University Hospital, Seoul, Republic of Korea Yuhan Corporation, Seoul, Republic of Korea Seoul National University Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Yongho', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Hyun-Shik', 'Initials': 'HS', 'LastName': 'Son', 'Affiliation': ''}, {'ForeName': 'Ki-Ho', 'Initials': 'KH', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Sang Yong', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Choon Hee', 'Initials': 'CH', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Hak Chul', 'Initials': 'HC', 'LastName': 'Jang', 'Affiliation': ''}, {'ForeName': 'Kwan-Woo', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Bong Yun', 'Initials': 'BY', 'LastName': 'Cha', 'Affiliation': ''}, {'ForeName': 'Kee-Ho', 'Initials': 'KH', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Young Kwon', 'Initials': 'YK', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'Pyung-Bok', 'Initials': 'PB', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Beom Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Sohee', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Taewon', 'Initials': 'T', 'LastName': 'An', 'Affiliation': ''}, {'ForeName': 'Yong-Chul', 'Initials': 'YC', 'LastName': 'Kim', 'Affiliation': ''}]",The Clinical journal of pain,['10.1097/AJP.0000000000001028']
2604,35220313,Dairy product intake modifies microRNAs expression among individuals with hyperinsulinemia - A post-intervention cross-sectional study.,"INTRODUCTION


microRNA (miRNA) profiles have been shown to change after intake of dairy products. Dysregulation of miRNA is associated with the changes in the level of glycemic parameters. The objectives are 1- to investigate miRNAs expression after consumption of dairy products; and 2- to study the association between miRNAs and glycemic profile among individuals with hyperinsulinemia.
METHODS


In crossover design, 24 participants were randomized into 2 phases: high-dairy (HD) (≥4 servings / day according to the Canadian Food Guide (2007)) and adequate-dairy (AD) (≤2 servings / day) over 6-week. First, miRNAs were extracted from a pooled plasma sample of 10 subjects after HD and AD intervention which analyzed in duplicate by array hybridization (Affymetrix Gene Chip miRNA Array v. 4.0). Secondly, 6 miRNAs related to type 2 diabetes (T2D) were validated by qRT-PCR from plasma of 24 participants.
RESULTS


Microarray analysis indicated that 237 miRNAs expressed differentially (FC ≥ ±1.2; p value < 0.05)) between AD and HD. Among pooled miRNAs, the level of selected miRNAs, including miR-652-3p, miR-106b-5p, miR-93-5p, and miR-107 were down-regulated; conversely, miR-223-3p and miR-122-5p were up-regulated. After qRT-PCR validation, only the expression level of miR-106-5p increased after HD compared to AD (p = 0.02). After AD intervention, the level of fasting plasma glucose (FPG) and insulin, HOMA-IR were negatively correlated with miR-122-5p. Similarly, negative correlation was found between miR-106-5p and FPG.
CONCLUSION


The miRNAs profile was modified after HD compared to AD and this may have role in modifying the risk of T2D (Registration number: NCT02961179).",2022,"After qRT-PCR validation, only the expression level of miR-106-5p increased after HD compared to AD (p = 0.02).","['individuals with hyperinsulinemia - A post-intervention cross-sectional study', '24 participants were randomized into 2 phases', 'individuals with hyperinsulinemia']","['Dairy product intake', 'high-dairy (HD) (≥4 servings / day according to the Canadian Food Guide (2007)) and adequate-dairy (AD']","['level of fasting plasma glucose (FPG) and insulin, HOMA-IR', 'expression level of miR-106']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0439560', 'cui_str': 'Phase 2'}]","[{'cui': 'C0010947', 'cui_str': 'Dairy foods'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}]",24.0,0.146895,"After qRT-PCR validation, only the expression level of miR-106-5p increased after HD compared to AD (p = 0.02).","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Khorraminezhad', 'Affiliation': ''}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Rudkowska', 'Affiliation': ''}]",Lifestyle genomics,['10.1159/000523809']
2605,35220595,Early offset-increasing migration predicts later revision for humeral head resurfacing implants. A randomized controlled radiostereometry trial with 10-year clinical follow-up.,"In a randomized controlled setting, medium-term implant migration and long-term clinical outcomes were compared for the Copeland and the Global C.A.P. humeral head resurfacing implants (HHRI). Thirty-two patients (mean age 63 years) were randomly allocated to a Copeland (n = 14) or Global C.A.P. (n = 18) HHRI. Patients were followed for 5 years with radiostereometry, Constant Shoulder Score, and the Western Ontario Osteoarthritis of the Shoulder Index (WOOS). WOOS and revision status were also obtained cross-sectionally at a mean 10-year follow-up. At the 5-year follow-up, total translation (TT) was 0.75 mm (95% confidence interval [CI]: 0.53-0.97) for the Copeland HHRIs and 1.15 mm (95% CI: 0.85-1.46) for the Global C.A.P. HHRIs (p = 0.04), but the clinical scores were similar at all follow-ups. The cumulative risks of revision at 5 and 10 years were 29% and 43% for Copeland and 35% and 41% for Global C.A.P HHRIs (p > 0.7). No implants were loose at revision, but HHRIs that were later revised followed an early offset-increasing migration pattern with medial translation and lift-off resulting in a mean 0.53 mm (95% CI: 0.18-0.88) higher TT at the 1-year follow-up compared to non-revised HHRIs. In conclusion, the Global C.A.P. HHRI had higher TT compared with the Copeland HHRI, but clinical scores and revision rates were similar. Nonetheless, revision rates were high and challenge the use of HHRIs. Interestingly, an early radiostereometry evaluated HHRI migration pattern with increased off-set predicted later implant revision.",2022,"At the 5-year follow-up, total translation (TT) was 0.75 mm (95% confidence interval [CI]: 0.53-0.97) for the Copeland HHRIs and 1.15 mm (95% CI: 0.85-1.46) for the Global C.A.P. HHRIs (","['Thirty-two patients (mean age 63 years', 'humeral head resurfacing implants']",['Global C.A.P. (n\u2009=\u200918) HHRI'],"['clinical scores', 'total translation (TT', 'revision rates', 'cumulative risks of revision', 'WOOS and revision status', 'Western Ontario Osteoarthritis of the Shoulder Index (WOOS', 'HHRI migration pattern', 'clinical scores and revision rates']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0223683', 'cui_str': 'Structure of head of humerus'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0223683', 'cui_str': 'Structure of head of humerus'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0409939', 'cui_str': 'Osteoarthritis of glenohumeral joint'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449242', 'cui_str': 'Revision status'}, {'cui': 'C0223683', 'cui_str': 'Structure of head of humerus'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",,0.0891121,"At the 5-year follow-up, total translation (TT) was 0.75 mm (95% confidence interval [CI]: 0.53-0.97) for the Copeland HHRIs and 1.15 mm (95% CI: 0.85-1.46) for the Global C.A.P. HHRIs (","[{'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Tøttrup', 'Affiliation': 'AutoRSA Research Group, Orthopaedic Research Unit, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Janni Kjaergaard', 'Initials': 'JK', 'LastName': 'Thillemann', 'Affiliation': 'AutoRSA Research Group, Orthopaedic Research Unit, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Theis Muncholm', 'Initials': 'TM', 'LastName': 'Thillemann', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Mechlenburg', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klebe', 'Affiliation': 'Department of Orthopaedics, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Søballe', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Maiken', 'Initials': 'M', 'LastName': 'Stilling', 'Affiliation': 'AutoRSA Research Group, Orthopaedic Research Unit, Aarhus University Hospital, Aarhus, Denmark.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.25298']
2606,35220556,"Correction to: Efficacy and Safety Results from a Phase 2, Randomized, Double Blind Study of Enzalutamide Versus Placebo in Advanced Hepatocellular Carcinoma.",,2022,,['Advanced Hepatocellular Carcinoma'],['Enzalutamide Versus Placebo'],['Efficacy and Safety'],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.629669,,"[{'ForeName': 'Baek-Yeol', 'Initials': 'BY', 'LastName': 'Ryoo', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. ryooby@amc.seoul.kr.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': 'Liverpool CR UK/NIHR Experimental Cancer Medicine Centre, and The Clatterbridge Cancer Centre, Liverpool, UK.'}, {'ForeName': 'Sook Ryun', 'Initials': 'SR', 'LastName': 'Park', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.'}, {'ForeName': 'Debashis', 'Initials': 'D', 'LastName': 'Sarker', 'Affiliation': ""School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Daniele', 'Affiliation': 'Department of Oncology, G. Rummo Hospital, Benevento, Italy.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Steinberg', 'Affiliation': 'Astellas Pharma Inc., Northbrook, IL, USA.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'López', 'Affiliation': 'Data Science, Astellas Pharma Inc., Leiden, The Netherlands.'}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}]",Clinical drug investigation,['10.1007/s40261-022-01132-y']
2607,35220995,Exercise to prevent shoulder problems after breast cancer surgery: the PROSPER RCT.,"BACKGROUND


Upper limb problems are common after breast cancer treatment.
OBJECTIVES


To investigate the clinical effectiveness and cost-effectiveness of a structured exercise programme compared with usual care on upper limb function, health-related outcomes and costs in women undergoing breast cancer surgery.
DESIGN


This was a two-arm, pragmatic, randomised controlled trial with embedded qualitative research, process evaluation and parallel economic analysis; the unit of randomisation was the individual (allocated ratio 1 : 1).
SETTING


Breast cancer centres, secondary care.
PARTICIPANTS


Women aged ≥ 18 years who had been diagnosed with breast cancer and were at higher risk of developing shoulder problems. Women were screened to identify their risk status.
INTERVENTIONS


All participants received usual-care information leaflets. Those randomised to exercise were referred to physiotherapy for an early, structured exercise programme (three to six face-to-face appointments that included strengthening, physical activity and behavioural change strategies).
MAIN OUTCOME MEASURES


The primary outcome was upper limb function at 12 months as assessed using the Disabilities of Arm, Hand and Shoulder questionnaire. Secondary outcomes were function (Disabilities of Arm, Hand and Shoulder questionnaire subscales), pain, complications (e.g. wound-related complications, lymphoedema), health-related quality of life (e.g. EuroQol-5 Dimensions, five-level version; Short Form questionnaire-12 items), physical activity and health service resource use. The economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit gained from an NHS and Personal Social Services perspective. Participants and physiotherapists were not blinded to group assignment, but data collectors were blinded.
RESULTS


Between 2016 and 2017, we randomised 392 participants from 17 breast cancer centres across England: 196 (50%) to the usual-care group and 196 (50%) to the exercise group. Ten participants (10/392; 3%) were withdrawn at randomisation and 32 (8%) did not provide complete baseline data. A total of 175 participants (89%) from each treatment group provided baseline data. Participants' mean age was 58.1 years (standard deviation 12.1 years; range 28-88 years). Most participants had undergone axillary node clearance surgery (327/392; 83%) and 317 (81%) had received radiotherapy. Uptake of the exercise treatment was high, with 181 out of 196 (92%) participants attending at least one physiotherapy appointment. Compliance with exercise was good: 143 out of 196 (73%) participants completed three or more physiotherapy sessions. At 12 months, 274 out of 392 (70%) participants returned questionnaires. Improvement in arm function was greater in the exercise group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 16.3 (standard deviation 17.6)] than in the usual-care group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 23.7 (standard deviation 22.9)] at 12 months for intention-to-treat (adjusted mean difference Disabilities of Arm, Hand and Shoulder questionnaire score of -7.81, 95% confidence interval -12.44 to -3.17;  p  = 0.001) and complier-average causal effect analyses (adjusted mean difference -8.74, 95% confidence interval -13.71 to -3.77;  p  ≤ 0.001). At 12 months, pain scores were lower and physical health-related quality of life was higher in the exercise group than in the usual-care group (Short Form questionnaire-12 items, mean difference 4.39, 95% confidence interval 1.74 to 7.04;  p  = 0.001). We found no differences in the rate of adverse events or lymphoedema over 12 months. The qualitative findings suggested that women found the exercise programme beneficial and enjoyable. Exercise accrued lower costs (-£387, 95% CI -£2491 to £1718) and generated more quality-adjusted life years (0.029, 95% CI 0.001 to 0.056) than usual care over 12 months. The cost-effectiveness analysis indicated that exercise was more cost-effective and that the results were robust to sensitivity analyses. Exercise was relatively cheap to implement (£129 per participant) and associated with lower health-care costs than usual care and improved health-related quality of life. Benefits may accrue beyond the end of the trial.
LIMITATIONS


Postal follow-up was lower than estimated; however, the study was adequately powered. No serious adverse events directly related to the intervention were reported.
CONCLUSIONS


This trial provided robust evidence that referral for early, supported exercise after breast cancer surgery improved shoulder function in those at risk of shoulder problems and was associated with lower health-care costs than usual care and improved health-related quality of life.
FUTURE WORK


Future work should focus on the implementation of exercise programmes in clinical practice for those at highest risk of shoulder problems.
TRIAL REGISTRATION


This trial is registered as ISRCTN35358984.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 26, No. 15. See the NIHR Journals Library website for further project information.",2022,"Improvement in arm function was greater in the exercise group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 16.3 (standard deviation 17.6)] than in the usual-care group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 23.7 (standard deviation 22.9)] at 12 months for intention-to-treat (adjusted mean difference Disabilities of Arm, Hand and Shoulder questionnaire score of -7.81, 95% confidence interval -12.44 to -3.17;  p  = 0.001) and complier-average causal effect analyses (adjusted mean difference -8.74, 95% confidence interval -13.71 to -3.77;  p  ≤ 0.001).","['Between 2016 and 2017', 'Breast cancer centres, secondary care', '181 out of 196 (92%) participants attending at least one physiotherapy appointment', ""Participants' mean age was 58.1 years (standard deviation 12.1 years; range 28-88 years"", 'women undergoing breast cancer surgery', 'Women aged ≥\u200918 years who had been diagnosed with breast cancer and were at higher risk of developing shoulder problems', '392 participants from 17 breast cancer centres across England: 196 (50%) to the usual-care group and 196 (50%) to the exercise group', 'shoulder problems after breast cancer surgery']","['usual care', 'structured exercise programme (three to six face-to-face appointments that included strengthening, physical activity and behavioural change strategies', 'Exercise', 'usual-care information leaflets', 'radiotherapy', 'structured exercise programme']","['rate of adverse events or lymphoedema', 'lower health-care costs than usual care and improved health-related quality of life', 'quality-adjusted life years', 'undergone axillary node clearance surgery', 'Shoulder questionnaire score', 'function (Disabilities of Arm, Hand and Shoulder questionnaire subscales), pain, complications (e.g. wound-related complications, lymphoedema), health-related quality of life (e.g. EuroQol-5 Dimensions, five-level version; Short Form questionnaire-12 items), physical activity and health service resource use', 'pain scores', 'clinical effectiveness and cost-effectiveness', 'health-related quality of life', 'mean Disabilities of Arm, Hand and Shoulder questionnaire score', 'Disabilities of Arm, Hand and Shoulder questionnaire', 'shoulder function', 'cost-effective', 'physical health-related quality of life', 'upper limb function']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]",392.0,0.121358,"Improvement in arm function was greater in the exercise group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 16.3 (standard deviation 17.6)] than in the usual-care group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 23.7 (standard deviation 22.9)] at 12 months for intention-to-treat (adjusted mean difference Disabilities of Arm, Hand and Shoulder questionnaire score of -7.81, 95% confidence interval -12.44 to -3.17;  p  = 0.001) and complier-average causal effect analyses (adjusted mean difference -8.74, 95% confidence interval -13.71 to -3.77;  p  ≤ 0.001).","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Mazuquin', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Mistry', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Rees', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Canaway', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Anower', 'Initials': 'A', 'LastName': 'Hossain', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Williamson', 'Affiliation': 'Centre for Rehabilitation Research, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Padfield', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Richmond', 'Affiliation': ""Primary Healthcare Research Unit, Faculty of Medicine, Memorial University of Newfoundland, St John's, NL, Canada.""}, {'ForeName': 'Loraine', 'Initials': 'L', 'LastName': 'Chowdhury', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Lait', 'Affiliation': 'Gloucestershire Care Services NHS Trust, Gloucester, UK.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Petrou', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Booth', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Raghavan', 'Initials': 'R', 'LastName': 'Vidya', 'Affiliation': 'Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Thompson', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}]","Health technology assessment (Winchester, England)",['10.3310/JKNZ2003']
2608,35220948,The safty profile of blood salvage applied for collected blood with amniotic fluid during cesarean section.,"BACKGROUND


The guidelines of National Health Service(NHS, the United Kingdom) recommended for use in obstetrics at increased risk of bleeding, requiring two suction devices to reduce amniotic fluid contamination, however, when comes to massive hemorrhage, it is may difficult to operate because the complex operation may delay time. The aim of the study was to detect the effect of amniotic fluid recovery on intraoperative cell salvage in obstetrics and provide evidence for clinical applications.
METHOD


Thirty-four patients undergoing elective cesarean section were randomly divided into two groups. In group 1, the cumulative blood from the operation field, including the amniotic fluid, was collected using a single suction device for processing. In group 2, after suctioning away the amniotic fluid using another suction device for the cumulative blood from the operation field. From each group, four samples were taken, including maternal venous blood (sample I), blood before washing (sample II), blood after washing (sample III) and blood after filtration with a leukocyte filter (sample IV), to detect serum potassium (K +), hemoglobin (Hb), white blood cell (WBC), fetal hemoglobin (HbF), alpha fetoprotein (AFP) and squamous cell (SC) levels.
RESULTS


The AFP, K + and WBC levels of sample III and sample IV were significantly lower than sample I in group 1 and group 2 (P < 0.05). Significantly more SCs were found in sample III than in sample I in group 1 and group 2 (P < 0.05), but SCs of sample IV had no statistical difference compared to sample I in group 1 and group 2 (P > 0.05). There was no significant difference in the K + , Hb, WBC, AFP and SC levels of sample IV between group 1 and group 2 (P > 0.05). The HbF levels of sample III and sample IV were significantly higher in group 1 than in group 2 (P < 0.05).
CONCLUSION


There is little or no possibility for AF contamination to enter the re-infusion system when used in conjunction with a leucodepletion filter. For maternal with Rh-negative blood, we recommend two suction devices to reduce HbF pollution.
TRIAL REGISTRATION


ChiCTR1800015684 , 2018.4.15.",2022,"The AFP, K + and WBC levels of sample III and sample IV were significantly lower than sample I in group 1 and group 2 (P < 0.05).","['collected blood with amniotic fluid during cesarean section', 'Thirty-four patients undergoing elective cesarean section']",['amniotic fluid recovery'],"['maternal venous\xa0blood (sample I), blood before washing (sample II), blood after washing (sample III) and blood after filtration with a leukocyte filter (sample IV), to detect serum potassium (K\u2009+), hemoglobin (Hb), white blood cell (WBC), fetal hemoglobin (HbF), alpha fetoprotein (AFP) and squamous cell (SC) levels', 'K\u2009+\u2009, Hb, WBC, AFP and SC levels of sample IV', 'HbF levels of sample III and sample IV', 'AFP, K\u2009+\u2009and WBC levels of sample III and sample IV']","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0002638', 'cui_str': 'Amniotic fluid'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0002638', 'cui_str': 'Amniotic fluid'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0015936', 'cui_str': 'Hemoglobin F'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C0221910', 'cui_str': 'Squamous epithelial cell'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",34.0,0.0718083,"The AFP, K + and WBC levels of sample III and sample IV were significantly lower than sample I in group 1 and group 2 (P < 0.05).","[{'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Rong', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Beijing, China. yippeerong@139.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Beijing, China.'}]",BMC pregnancy and childbirth,['10.1186/s12884-022-04488-3']
2609,35220869,"Safety of primary immunization with a DTwP-HBV/Hib vaccine in healthy infants: a prospective, open-label, interventional, phase IV clinical study.","OBJECTIVE


This study aimed to assess the safety of a fully liquid DTwP-HBV/Hib pentavalent vaccine (Eupenta TM ) based on the occurrence of adverse events (AEs) following vaccination.
METHODS


This was a prospective, open-label, single-arm, interventional phase IV study. A single intramuscular injection of the study vaccine was administered to infants at approximately 6, 10, and 14 weeks of age, and an end-of-study follow-up visit was scheduled at 18 weeks. Safety data, including immediate reactions, solicited AEs, unsolicited AEs, vital signs, and physical examination findings were collected.
RESULTS


In all, 3000 subjects were enrolled and received at least one dose of the study vaccine. Of these, 2717 (90.6%) experienced at least one AE, most considered related to the study vaccine. Immediate reactions, solicited and unsolicited AEs were respectively identified in 224 (7.5%), 2,652 (88.4%), and 1,099 (36.6%) subjects. The most prevalent solicited and unsolicited AEs comprised pain/tenderness and upper respiratory tract infection, respectively. Most AEs were mildly or moderately severe. Forty-one (1.4%) subjects had at least one serious AE (SAE); of these, two (0.1%) had two SAEs each, considered related to the study vaccine. Six (0.2%) subjects died due to unsolicited AEs, none of which were considered related to the study vaccine. No AEs were reported at the end-of-study follow-up visit.
CONCLUSIONS


The study vaccine administered to infants at 6, 10, and 14 weeks of age had a safety profile similar to that reported in a previous clinical study, and did not result in an increased risk of AEs known to be associated with DTwP-based vaccines or previously unrecognized SAEs.",2022,"The most prevalent solicited and unsolicited AEs comprised pain/tenderness and upper respiratory tract infection, respectively.","['3000 subjects were enrolled and received at least one dose of the study vaccine', 'healthy infants']","['primary immunization with a DTwP-HBV/Hib vaccine', 'fully liquid DTwP-HBV/Hib pentavalent vaccine (Eupenta TM ']","['immediate reactions, solicited AEs, unsolicited AEs, vital signs, and physical examination findings', 'Immediate reactions, solicited and unsolicited AEs', 'pain/tenderness and upper respiratory tract infection']","[{'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C1328526', 'cui_str': 'Primary immunization'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0062086', 'cui_str': 'Haemophilus influenzae Type b vaccine'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0018482', 'cui_str': 'Haemophilus infection'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}]",3000.0,0.121597,"The most prevalent solicited and unsolicited AEs comprised pain/tenderness and upper respiratory tract infection, respectively.","[{'ForeName': 'Maria Rosario Z', 'Initials': 'MRZ', 'LastName': 'Capeding', 'Affiliation': 'Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines.'}, {'ForeName': 'Salvacion R', 'Initials': 'SR', 'LastName': 'Gatchalian', 'Affiliation': 'Department of Pediatrics, Philippine General Hospital, Manila, Philippines.'}, {'ForeName': 'Mitzi', 'Initials': 'M', 'LastName': 'Aseron', 'Affiliation': 'Department of Pediatrics, University of Perpetual Help Dalta Medical Center, Las Piñas City, Philippines.'}, {'ForeName': 'Anna Lena L', 'Initials': 'ALL', 'LastName': 'Lopez', 'Affiliation': 'Institute of Child Health and Human Development, University of the Philippines Manila - National Institutes of Health, Philippines.'}, {'ForeName': 'Delia C', 'Initials': 'DC', 'LastName': 'Yu', 'Affiliation': 'De La Salle University, Cavite, Philippines.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Garcia Ibe', 'Affiliation': ""St. Luke's Medical Center, Quezon City, Philippines.""}, {'ForeName': 'Maria Nerissa', 'Initials': 'MN', 'LastName': 'De Leon', 'Affiliation': 'Philippine Heart Center, Quezon City, Philippines.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Modequillo', 'Affiliation': 'Department of Pediatrics, Perpetual Succour Hospital, Cebu, Philippines.'}, {'ForeName': 'Mervin Edcel E', 'Initials': 'MEE', 'LastName': 'Flavier', 'Affiliation': 'Southern Philippines Medical Center, Davao City, Philippines.'}, {'ForeName': 'Anna Lisa', 'Initials': 'AL', 'LastName': 'Ong-Lim', 'Affiliation': 'Department of Pediatrics, Philippine General Hospital, University of the Philippines Manila.'}]",Expert review of vaccines,['10.1080/14760584.2022.2046469']
2610,35221104,Bleeding Episodes in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome Undergoing Very Early Versus Standard Care Invasive Examination (from the Very EaRly vs Deferred Invasive Evaluation Using Computerised Tomography [VERDICT] Trial).,"Bleeding is known to influence the prognosis in patients with acute coronary syndromes. In this predefined secondary outcome analysis of the Very EaRly vs Deferred Invasive evaluation using Computerized Tomography (VERDICT) trial, we investigated whether a very early invasive coronary angiography (ICA), compared with one performed within 48 to 72 hours (standard care), was associated with fewer serious bleedings. Furthermore, we tested the association between demographic data including GRACE score and serious bleedings as well as bleedings and mortality. In the 2,147 patients included in the main study, bleedings within 30 days of admission were assessed based on Thrombolysis In Myocardial Infarction and Bleeding Academic Research Consortium criteria. Differences were calculated by cumulative incidence methods and Grays test. Variables associated with bleeding and mortality were estimated by Cox proportional hazard models. Serious (Bleeding Academic Research Consortium 3abc) bleeding rates were low (15 [1.4%, standard] vs 12 [1.2%, early], p = 0.56). There were no fatal bleedings or serious bleedings before ICA in either group. By multivariate analysis, there was no difference in bleedings between the 2 groups. Female gender (hazard ratio [HR] 2.7, 95% confidence interval [CI] 1.2 to 6.4; p = 0.02), anemia (HR 7.0, 95% CI 2.8 to 17.0; p <0.001), and increasing blood pressure (HR 1.3, 95% CI 1.1 to 1.5; p = 0.01) were individually associated with serious bleeding, whereas GRACE score >140 was not (HR 1.03, 95% CI 0.4 to 2.9; p = 0.96). In conclusion, serious bleedings were few, and there were none before ICA in either group. A very early invasive strategy did not reduce serious bleedings within 30 days, which was associated with female gender, increasing blood pressure, and anemia.",2022,"Serious (Bleeding Academic Research Consortium 3abc) bleeding rates were low (15 [1.4%, standard] vs 12 [1.2%, early], p = 0.56).","['2,147 patients included in the main study, bleedings within 30\xa0days of admission were assessed based on Thrombolysis', 'patients with acute coronary syndromes', 'Female gender (hazard ratio [HR', 'Patients With Non-ST-Segment Elevation Acute Coronary Syndrome']",['Undergoing Very Early Versus Standard Care Invasive Examination'],"['bleedings and mortality', 'anemia', 'serious bleeding', 'blood pressure, and anemia', 'serious bleedings', 'Serious (Bleeding Academic Research Consortium 3abc) bleeding rates', 'bleedings', 'bleeding and mortality', 'blood pressure', 'GRACE score and serious bleedings', 'fatal bleedings or serious bleedings', 'Bleeding Episodes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",2147.0,0.145612,"Serious (Bleeding Academic Research Consortium 3abc) bleeding rates were low (15 [1.4%, standard] vs 12 [1.2%, early], p = 0.56).","[{'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Sadjadieh', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. Electronic address: Golnaz.Sadjadieh.02@regionh.dk.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbæk', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Kofoed', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars V', 'Initials': 'LV', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter Riis', 'Initials': 'PR', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Herlev and Gentofte University Hospital, Hellerup, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Department of Cardiology, Hillerød University Hospital, Hillerød, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Elming', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Gislason', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Herlev and Gentofte University Hospital, Hellerup, Denmark; The Danish Heart Foundation.'}, {'ForeName': 'Dan E', 'Initials': 'DE', 'LastName': 'Høfsten', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Holmvang', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",The American journal of cardiology,['10.1016/j.amjcard.2022.01.016']
2611,35221101,The effect of different pin configurations on cyclic stability in pediatric proximal humerus fracture fixation: A Sawbones model study.,"BACKGROUND


In sawbones with proximal humerus fracture model, three different fixation configurations, Parallel-Straight K-wires, Cross-Straight K-wires and Palm-Tree Method, were biomechanically compared.
METHODS


A total of 36 anatomical pediatric humerus sawbones models were used. They were divided into three equal groups; parallel fixation with straight K-wires (Group PS), cross fixation with straight K-wires (Group CS), and Palm-Tree Method (Group PT). Models were tested in abduction and torsional at a speed of 0.5 mm/s and a 0-5 mm displacement range. Loading (N) and Stiffness (N/mm) data were calculated and compared statistically.
RESULTS


Group PS was significantly higher than the other two groups in abduction bending cyclic load values (P<0.001). It was also significantly higher in Group CS than in Group PT (P < 0.001). No significant differences were detected between the three different fixation groups' cyclic torsional load values (p < 0.05).
CONCLUSION


The parallel configuration with straight K-wires will provide a more stable fixation than the cross configuration with straight or Palm-Tree Method in pediatric proximal humeral sawbones fracture modeling.",2022,"No significant differences were detected between the three different fixation groups' cyclic torsional load values (p < 0.05).
",['pediatric proximal humerus fracture fixation'],"['parallel fixation with straight K-wires (Group PS), cross fixation with straight K-wires (Group CS), and Palm-Tree Method (Group PT', 'pin configurations']","['cyclic stability', 'cyclic torsional load values']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0588209', 'cui_str': 'Bone structure of proximal humerus'}, {'cui': 'C0016641', 'cui_str': 'Fixation of fracture'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0040811', 'cui_str': 'Tree'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0450425', 'cui_str': 'Torsional'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",36.0,0.0387013,"No significant differences were detected between the three different fixation groups' cyclic torsional load values (p < 0.05).
","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Kaya', 'Affiliation': 'Department of Orthopedics and Traumatology, Marmara University Pendik Training and Research Hospital, Istanbul, Turkey. Electronic address: kayamuratdr@gmail.com.'}, {'ForeName': 'Nazım', 'Initials': 'N', 'LastName': 'Karahan', 'Affiliation': 'Department of Orthopedics and Traumatology, Corlu District State Hospital, Tekirdag, Turkey. Electronic address: usta_84@hotmail.com.'}]",Injury,['10.1016/j.injury.2022.02.032']
2612,35221520,Home training with or without joint mobilization compared to no treatment: a randomized controlled trial.,"[Purpose] To investigate if joint mobilization in patients with subacromial pain syndrome has additional benefits to a home training program on shoulder function and pain, and to compare home training to no physical therapy. [Participants and Methods] Eighty-nine primary care patients (mean age 45 years) with subacromial pain syndrome during an average of 23 weeks. Home training was performed twice a day during a 12 week period. One of the intervention groups received add-on shoulder joint mobilization to the home training. A third group did not receive any physical therapy. Constant-Murley score, pain and active range of motion was evaluated at baseline, 6 weeks, 12 weeks and 6 months. [Results] The total Constant-Murley score revealed no significant differences between groups at any time point. All groups improved over time. The add-on joint mobilization group reached clinical important change at 12 weeks. The subscale pain showed that both intervention groups reported less pain after 12 weeks compared to the reference group. [Conclusion] Home training is not superior to no treatment evaluated with the total Constant-Murley score. However, home training with or without add-on joint mobilization may decrease pain compared to no treatment.",2022,The total Constant-Murley score revealed no significant differences between groups at any time point.,"['Participants and Methods] Eighty-nine primary care patients (mean age 45\u2005years) with subacromial pain syndrome during an average of 23 weeks', 'patients with subacromial pain syndrome']","['physical therapy', 'Home training with or without joint mobilization', 'home training program', 'joint mobilization']","['Constant-Murley score, pain and active range of motion', 'pain', 'subscale pain', 'total Constant-Murley score']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4728045', 'cui_str': 'Subacromial pain syndrome'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0231588', 'cui_str': 'Physiatric mobilization of joint'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",89.0,0.0221861,The total Constant-Murley score revealed no significant differences between groups at any time point.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Eliason', 'Affiliation': 'Stockholm Sports Trauma Research Center, Department of Molecular Medicine and Surgery, Karolinska Institutet: SE-171 76 Stockholm, Sweden.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Werner', 'Affiliation': 'Stockholm Sports Trauma Research Center, Department of Molecular Medicine and Surgery, Karolinska Institutet: SE-171 76 Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Engström', 'Affiliation': 'Stockholm Sports Trauma Research Center, Department of Molecular Medicine and Surgery, Karolinska Institutet: SE-171 76 Stockholm, Sweden.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Harringe', 'Affiliation': 'Stockholm Sports Trauma Research Center, Department of Molecular Medicine and Surgery, Karolinska Institutet: SE-171 76 Stockholm, Sweden.'}]",Journal of physical therapy science,['10.1589/jpts.34.153']
2613,35221513,Effects of an additional resistance training intervention in hemodialysis patients performing long-term ergometer exercise during dialysis.,"[Purpose] To verify the effect of a 12-week additional resistance training intervention in patients on hemodialysis who had been performing supine ergometer exercises alone during dialysis. [Participants and Methods] Overall, 18 patients undergoing hemodialysis were included. A 12-week intervention with additional resistance training was conducted in hemodialysis patients who had been performing supine ergometer exercise for 30 min during dialysis for over >3 months. Physical function before and after the period of bicycle ergometer exercise alone and before and during the additional intervention was compared. Resistance training consisted of 1-3 sets per day of five different exercises for the large muscle groups of the upper and lower limbs. [Results] The results of the 6-min walk test improved significantly after the additional intervention. The average driving distance in the supine ergometer exercise during the additional intervention was identified as an associated factor. [Conclusion] The addition of the resistance training to long-term supine ergometer exercisers improved walking endurance. When supine ergometer exercise alone does not change physical function, the additional use of resistance training subsequently may have a positive effect on walking endurance.",2022,The results of the 6-min walk test improved significantly after the additional intervention.,"['Participants and Methods', '18 patients undergoing hemodialysis were included', 'patients on hemodialysis who had been performing supine ergometer exercises alone during dialysis', 'hemodialysis patients who had been performing', 'hemodialysis patients performing long-term ergometer exercise during dialysis']","['bicycle ergometer exercise', 'additional resistance training', 'supine ergometer exercise', 'supine ergometer exercise alone', 'resistance training to long-term supine ergometer exercisers', 'additional resistance training intervention']","['6-min walk test', 'Physical function', 'walking endurance', 'average driving distance']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0180749', 'cui_str': 'Bicycle ergometer'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",18.0,0.0155045,The results of the 6-min walk test improved significantly after the additional intervention.,"[{'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Noguchi', 'Affiliation': 'Faculty of Health Science, Kinjo University: 1200 Kasama-machi, Hakusan, Ishikawa 924-8511, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Youhira', 'Affiliation': 'Department of Physical Therapy, Mizuho Hospital, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Department of Physical Therapy, Mizuho Hospital, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Department of Physical Therapy, Mizuho Hospital, Japan.'}, {'ForeName': 'Mayu', 'Initials': 'M', 'LastName': 'Odaira', 'Affiliation': 'Department of Physical Therapy, Mizuho Hospital, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Anabata', 'Affiliation': 'Department of Physical Therapy, Mizuho Hospital, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Koshino', 'Affiliation': 'Department of Internal Medicine, Mizuho Hospital, Japan.'}]",Journal of physical therapy science,['10.1589/jpts.34.110']
2614,35221319,"Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Two Probiotics on the Preterms' Gut Microbiota.","OBJECTIVE


To evaluate the effect of a new probiotic strain combination, Ligilactobacillus salivarius PS11603 and Bifidobacterium longum PS10402, on gut bacterial colonization of preterm infants.
METHODS


A randomized, double-blind, placebo-controlled study was conducted in preterm infants from 28 weeks + 0 days to 30 weeks + 6 days of gestation. Thirty preterm infants were randomly selected after birth to receive either probiotics or placebo. Stool samples were collected prior to product intake and then sequentially during the first weeks of their admission. Classical microbiological, metagenomics and multiplex immunological analyses were performed to assess the bacterial and immune profile of the samples.
RESULTS


Twenty-seven infants completed the study (14 vs 13, probiotic and placebo groups). A higher number of participants were colonized by Lactobacilli was higher in the probiotic group than in placebo group (93% vs 46%; p = 0.013). Similar results were obtained when analysing bifidobacterial colonization (100% vs 69%; p = 0.041). Earlier colonization was observed in the probiotics group vs the placebo group, specifically 5 weeks for Lactobacillus and 1 week for Bifidobacterium. Although no effect was observed in the fecal immunological profile, a decreasing trend could be seen in Th17 response during the first week of probiotic treatment. None of the adverse events (AEs) registered were related to product intake.
CONCLUSION


Probiotic supplementation with L. salivarius PS11603 and B. longum PS10402 enhanced an earlier colonization of Lactobacillus and Bifidobacterium in preterm infants' guts in 5 and 1 week respectively. A higher number of infants were colonized by Lactobacilli with the probiotics' intake at the end of the study.",2022,A higher number of infants were colonized by Lactobacilli with the probiotics' intake at the end of the study.,"['preterm infants from 28\u200aweeks\u200a+\u200a0\u200adays to 30\u200aweeks', 'Thirty preterm infants', 'preterm infants']","['placebo', 'new probiotic strain combination, Ligilactobacillus salivarius PS11603 and Bifidobacterium longum PS10402', 'Placebo', 'Two Probiotics', '\u200a6\u200adays of gestation', 'probiotics or placebo']","['bifidobacterial colonization', 'fecal immunological profile', 'earlier colonization of Lactobacillus and Bifidobacterium', 'Earlier colonization']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]",30.0,0.38932,A higher number of infants were colonized by Lactobacilli with the probiotics' intake at the end of the study.,"[{'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'Moreno-Sanz', 'Affiliation': 'Department of Neonatology, La Paz University Hospital, Paseo de la Castellana 261, Madrid, Spain Hospital La Paz Institute for Health Research IdIPAZ, c/Pedro Rico 6, Madrid, Spain Probisearch, SLU, c/Santiago Grisolía, 2, Tres Cantos, Spain Department of Pediatrics. Autónoma University, Madrid. Spain.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Montes', 'Affiliation': ''}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Manzano', 'Affiliation': ''}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Espinosa-Martos', 'Affiliation': ''}, {'ForeName': 'Nivia', 'Initials': 'N', 'LastName': 'Cárdenas', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Esteban', 'Affiliation': ''}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cruz', 'Affiliation': ''}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Jiménez', 'Affiliation': ''}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Sáenz de Pipaón', 'Affiliation': ''}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000003427']
2615,35221304,Effectiveness of dexamethasone or adrenaline with lignocaine 2% for prolonging inferior alveolar nerve block: a randomized controlled trial.,"Objectives


Inferior alveolar nerve block (IANB) is commonly used for mandibular dentoalveolar surgery. The objective of this study was to evaluate and compare the effectiveness of coadministration of dexamethasone (4 mg/mL) or adrenaline (0.01 mg/mL) as an adjuvant with lignocaine 2% in IANB during third molar surgery (TMS).
Patients and Methods


This double-blind, randomized controlled trial was conducted between March and August 2020. The investigators screened patients needing elective TMS under local anesthesia. Based on strict inclusion and exclusion criteria, patients were enrolled in this study. These patients were assigned randomly into two study groups: dexamethasone group (DXN) or adrenaline group (ADN). Outcome variables were postoperative edema, trismus, visual analogue scale (VAS), perioperative analgesia, onset time, and duration of IANB.
Results


Eighty-three patients were enrolled in this study, of whom 23 (27.7%) were eliminated or excluded during follow-up. This study thus included data from 60 samples. Mean age was 32.28±11.74 years, including 28 females (46.7%) in the ADN (16 patients, 57.1%) and DXN (12 patients, 42.9%) groups. The duration of action for DXN (mean±standard deviation [SD], 4:02:07±0:34:01 hours; standard error [SE], 0:06:00 hours; log-rank  P =0.001) and for ADN (mean±SD, 1:58:34±0:24:52 hours; SE, 0:04:42 hours; log-rank  P =0.001) were found. Similarly, time at which 1st analgesic consume and total number of nonsteroidal antiinflammatory drugs need to rescue postoperative analgesia was found statistically significant between study groups (t (58)=-11.95; confidence interval, -2:25:41 to -1:43:53;  P =0.001). Early-hours VAS was also significantly different between the study groups.
Conclusion


A single injection of dexamethasone prolongs the duration of action of lignocaine 2% IANB. Additionally, it can be used in cases where adrenaline is contraindicated.",2022,"Early-hours VAS was also significantly different between the study groups.
","['patients needing elective TMS under local anesthesia', 'Mean age was 32.28±11.74 years, including 28 females (46.7%) in the ADN (16 patients, 57.1%) and DXN (12 patients, 42.9%) groups', 'Eighty-three patients were enrolled in this study, of whom 23 (27.7%) were eliminated or excluded during follow-up']","['dexamethasone or adrenaline', 'adrenaline', 'dexamethasone', 'Inferior alveolar nerve block (IANB', 'dexamethasone group (DXN) or adrenaline', 'lignocaine']","['time at which 1st analgesic consume and total number of nonsteroidal antiinflammatory drugs need to rescue postoperative analgesia', 'postoperative edema, trismus, visual analogue scale (VAS), perioperative analgesia, onset time, and duration of IANB', 'duration of action for DXN', 'prolonging inferior alveolar nerve block']","[{'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4517773', 'cui_str': '42.9'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1096288', 'cui_str': 'Perioperative analgesia'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]",83.0,0.218195,"Early-hours VAS was also significantly different between the study groups.
","[{'ForeName': 'Saroj Prasad', 'Initials': 'SP', 'LastName': 'Deo', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, National Medical College, Birgunj, Nepal.'}, {'ForeName': 'Md Shakeel', 'Initials': 'MS', 'LastName': 'Ahmad', 'Affiliation': 'Department of Dentistry, National Medical College, Birgunj, Nepal.'}, {'ForeName': 'Abanish', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Community Dentistry, MB Kedia Dental College, Birgunj, Nepal.'}]",Journal of the Korean Association of Oral and Maxillofacial Surgeons,['10.5125/jkaoms.2022.48.1.21']
2616,35221286,Effects of metformin and insulin on gestational diabetes mellitus: A dual drugs therapy approach.,"This study was aimed to investigate the combined effects of metformin hydrochloride and insulin during gestational diabetes mellitus. A total 136 patients were randomly divided into study and control group. The control group was treated with insulin only while the study group was additionally treated with metformin hydrochloride. Maternal-infant outcomes and the levels of fasting blood glucose (FBG), 2h postprandial blood glucose (2hPG), glycosylated hemoglobin (HbA1c), total cholesterol (TC), total bilirubin (TBil), uric acid (UA) and microalbunminuria (mAlb) before and after treatment were compared. In post-treatment, the levels of FBG, 2h PG and HbA1c were decreased significantly (p<0.05) in both groups compared with pre-treatment. The levels of TC, TBil, UA and mAlb in both groups were significantly improved compared with pre-treatment. Levels of TC, UA and mAlb in the study group were significantly lower while TBil level was higher than control group. Compared to the control group, the incidence of gestational hypertension and premature delivery were significantly lower in the study group. There was no significant difference in the incidence of neonatal respiratory distress. The combination of metformin hydrochloride and insulin has significant effect in the treatment of gestational diabetes mellitus.",2022,"The levels of TC, TBil, UA and mAlb in both groups were significantly improved compared with pre-treatment.","['A total 136 patients', 'gestational diabetes mellitus']","['metformin and insulin', 'metformin hydrochloride', 'metformin hydrochloride and insulin']","['levels of TC, TBil, UA and mAlb', 'incidence of neonatal respiratory distress', 'incidence of gestational hypertension and premature delivery', 'levels of FBG, 2h PG and HbA1c', 'Levels of TC, UA and mAlb', '2h postprandial blood glucose (2hPG), glycosylated hemoglobin (HbA1c), total cholesterol (TC), total bilirubin (TBil), uric acid (UA) and microalbunminuria (mAlb', 'Maternal-infant outcomes and the levels of fasting blood glucose (FBG', 'TBil level']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0770893', 'cui_str': 'Metformin hydrochloride'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0341934', 'cui_str': 'Transient hypertension of pregnancy'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement'}]",136.0,0.0133972,"The levels of TC, TBil, UA and mAlb in both groups were significantly improved compared with pre-treatment.","[{'ForeName': 'Yalou', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': ""Xingtai People's Hospital Department of Reproductive Medicine, HeBei, PR China.""}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Qiao', 'Affiliation': ""Xingtai People's Hospital Department of Reproductive Medicine, HeBei, PR China.""}, {'ForeName': 'Ruiying', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': ""Xingtai People's Hospital Department of Reproductive Medicine, HeBei, PR China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': ""Xingtai People's Hospital Department of Pharmacy, HeBei, PR China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Xingtai People's Hospital Department of Endocrinology, HeBei, PR China.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Xingtai People's Hospital Department of Emergency, HeBei, PR China.""}]",Pakistan journal of pharmaceutical sciences,[]
2617,35221282,Effect of ultra-low O2 (2%) tension on human in-vitro embryo development.,"The study was aimed to investigate the effect of culturing human in-vitro embryos in ultra-low O 2  (2%) tension. A total of 2298 oocytes from 152 patients between June 2017 and December 2017 treated with conventional in vitro fertilization (IVF) were harvested in this study. Oocytes were randomly assigned to the low (5%) or ultra-low (2%) O 2  tension groups on the retrieval day. We observed that the day 3 good quality embryos (43.32 versus 42.01%; p=.635) and available embryos (82.02 versus 83.47%; p=.490) rates were similar between 2% and 5% condition. No differences were observed in the D5 blastulation rate (62.79 versus 61.85%; p=.735) and the proportion of good quality blastocysts on Day 5 (44.51 versus 45.61%; p=.700), nor in the total blastulation rate (71.26 versus 70.29%; p=.710) between 2% and 5% condition. In the first transfer, the blastocysts had similar clinical pregnancy (68.12 versus 71.08%; p= .692) and ongoing pregnancy (59.42 versus 62.65%; p=.684) rates from 2% and 5% condition. The employ of ultra-low O 2  tension did not benefit for human in-vitro embryo development.",2022,We observed that the day 3 good quality embryos (43.32 versus 42.01%; p=.635) and available embryos (82.02 versus 83.47%; p=.490) rates were similar between 2% and 5% condition.,['A total of 2298 oocytes from 152 patients between June 2017 and December 2017 treated with conventional in vitro fertilization (IVF'],['ultra-low O2 (2%) tension'],"['quality embryos', 'clinical pregnancy', 'ongoing pregnancy', 'proportion of good quality blastocysts', 'D5 blastulation rate', 'total blastulation rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0233494', 'cui_str': 'Tension'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",2298.0,0.0284728,We observed that the day 3 good quality embryos (43.32 versus 42.01%; p=.635) and available embryos (82.02 versus 83.47%; p=.490) rates were similar between 2% and 5% condition.,"[{'ForeName': 'Mingzhao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""The ART Center, Northwest Women and Children's Hospital, Xi'an, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""The ART Center, Northwest Women and Children's Hospital, Xi'an, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': ""The ART Center, Northwest Women and Children's Hospital, Xi'an, China.""}]",Pakistan journal of pharmaceutical sciences,[]
2618,35221703,"A Comparative, Three-Arm, Randomized Clinical Trial to Evaluate the Effectiveness and Tolerability of Bilastine vs Fexofenadine vs Levocetirizine at the Standard Dose and Bilastine vs Fexofenadine at Higher Than the Standard Dose (Up-Dosing) vs Levocetirizine and Hydroxyzine (in Combination) in Patients with Chronic Spontaneous Urticaria.","Introduction


Though second-generation antihistamines (SGAH) are first-line drugs in chronic spontaneous urticaria (CSU), 50% of patients do not respond to them. In such patients, guidelines recommend either up-dosing of SGAH or combination of different antihistamines. However, the studies comparing these treatment regimens are limited.
Methods


In this comparative, three-arm study, CSU patients were randomized to receive standard dose of either bilastine, fexofenadine, or levocetirizine for 2 weeks. After 2 weeks of treatment, non-responders received double dose of either bilastine or fexofenadine, while hydroxyzine 25 mg once daily was added in the levocetirizine group. Patients were primarily evaluated for improvement in CSU, quality of life, and somnolence.
Results


A total of 110 patients with CSU were recruited. At the end of 4 weeks, 33/39, 26/35, and 22/36 patients in the bilastine, fexofenadine, and levocetirizine groups showed improvement in urticaria symptoms. At week 2, there was no statistical difference in urticaria activity score (UAS7) improvement between any of the groups; however, at week 4, there was a statistical difference between the bilastine and levocetirizine groups ( p <0.05). Somnolence was significantly lower in the bilastine group ( p <0.05). Bilastine was statistically significant ( p <0.05) in the improvement of quality of life as compared to both groups. No major adverse events were reported during study period; however, bilastine was associated with significantly lower levels of AEs compared to levocetirizine ( p <0.05).
Conclusion


Two-fold up-dosing of bilastine improves CSU symptoms without compromising safety as compared to two-fold up-dosing of fexofenadine and combination of first- and second-generation antihistamines.",2022,Bilastine was statistically significant ( p <0.05) in the improvement of quality of life as compared to both groups.,"['CSU patients', 'Patients with Chronic Spontaneous Urticaria', '110 patients with CSU were recruited']","['fexofenadine', 'bilastine, fexofenadine, or levocetirizine', 'Levocetirizine and Hydroxyzine', 'Bilastine', 'bilastine, fexofenadine', 'bilastine or fexofenadine, while hydroxyzine', 'Bilastine vs Fexofenadine vs Levocetirizine', 'antihistamines (SGAH', 'levocetirizine', 'bilastine', 'Bilastine vs Fexofenadine']","['Somnolence', 'CSU symptoms', 'Effectiveness and Tolerability', 'adverse events', 'quality of life', 'CSU, quality of life, and somnolence', 'urticaria activity score (UAS7) improvement', 'urticaria symptoms']","[{'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0296800', 'cui_str': 'fexofenadine'}, {'cui': 'C1101148', 'cui_str': 'bilastine'}, {'cui': 'C1174893', 'cui_str': 'levocetirizine'}, {'cui': 'C0020404', 'cui_str': 'Hydroxyzine'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C1136312', 'cui_str': 'Second Generation H1 Antagonists'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",110.0,0.066804,Bilastine was statistically significant ( p <0.05) in the improvement of quality of life as compared to both groups.,"[{'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Shah', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, B.J.Medical College, Civil Hospital, Ahmedabad, India.'}, {'ForeName': 'Dhiraj', 'Initials': 'D', 'LastName': 'Dhoot', 'Affiliation': 'DGM, Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, India.'}, {'ForeName': 'Ankita', 'Initials': 'A', 'LastName': 'Choudhary', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, B.J.Medical College, Civil Hospital, Ahmedabad, India.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Jangid', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, B.J.Medical College, Civil Hospital, Ahmedabad, India.'}, {'ForeName': 'Deval', 'Initials': 'D', 'LastName': 'Mistry', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, B.J.Medical College, Civil Hospital, Ahmedabad, India.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, B.J.Medical College, Civil Hospital, Ahmedabad, India.'}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Kamat', 'Affiliation': 'Department of Dermatology, Venereology and Leprosy, B.J.Medical College, Civil Hospital, Ahmedabad, India.'}, {'ForeName': 'Hanmant', 'Initials': 'H', 'LastName': 'Barkate', 'Affiliation': 'Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, India.'}]","Clinical, cosmetic and investigational dermatology",['10.2147/CCID.S350122']
2619,35221700,Health-Related Quality of Life of Patients Presenting to the Emergency Department with a Musculoskeletal Disorder.,"Background


Musculoskeletal disorders (MSKDs) are among the most disabling and costly non-fatal health conditions. They may lead to long-term consequences such as chronic pain, physical limitations, and poorer quality of life. They also account for a significant proportion of emergency department visits, representing between 18% and 25% of all visits, depending on country.
Purpose


To assess the health-related quality of life of patients presenting to the emergency department with a MSKD, to convert their answers to utility scores and to explore the association between diverse socio-demographic and clinical variables and patients' health-related quality of life.
Patients and Methods


This is an analysis of cross-sectional data obtained during the baseline assessment performed as part of a 6-month pragmatic randomized controlled trial conducted in an academic emergency department. We included patients aged 18-80 years with a minor MSKD. The main outcome measures were health-related quality of life (five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and utility scores (-0.148 - worse than death, 0 - dead, 0.949 - perfect health) measured with the EQ-5D-5L. Possible associations were explored by comparing scores across subgroups based on certain socio-demographic (eg, age, gender, triage score) and clinical factors (eg, pain interference on function, pain intensity) and with reference values using descriptive statistics (mean, median), rankFD ANOVAs, and  χ   2  tests.
Results


Sixty-nine participants completed the EQ-5D-5L. Mean and median utility scores were, respectively, 0.536 (95% CI: 0.479-0.594) and 0.531 (IQR: 0.356-0.760). Participants with higher levels of pain (<4/10: 0.741, 95% CI: 0.501-0.980; 4-7/10: 0.572, 0.500-0.644; >7/10: 0.433, 0.347-0.518) or pain interference on function (<4/10: 0.685, 95% CI: 0.605-0.764; 4-7/10: 0.463, 0.394-0.533; >7/10: 0.294, 0.126-0.463) presented significantly lower utility scores. No significant differences were found for other socio-demographic characteristics.
Conclusion


In patients with MSKDs who present to the emergency department, higher levels of pain or pain interference are associated with decreased health-related quality of life. These findings need to be confirmed on a larger scale.",2022,"Participants with higher levels of pain (<4/10: 0.741, 95% CI: 0.501-0.980; 4-7/10: 0.572, 0.500-0.644; >7/10: 0.433, 0.347-0.518) or pain interference on function (<4/10: 0.685, 95% CI: 0.605-0.764; 4-7/10: 0.463, 0.394-0.533; >7/10: 0.294, 0.126-0.463) presented significantly lower utility scores.","['academic emergency department', 'patients presenting to the emergency department with a MSKD', 'patients aged 18-80 years with a minor MSKD', 'Presenting to the Emergency Department with a Musculoskeletal Disorder']",['EQ-5D-5L'],"['pain', 'pain interference on function', 'Health-Related Quality of Life', 'health-related quality of life', 'pain or pain interference', 'certain socio-demographic (eg, age, gender, triage score) and clinical factors (eg, pain interference on function, pain intensity) and with reference values using descriptive statistics (mean, median), rankFD ANOVAs, and  χ   2  tests', 'health-related quality of life (five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and utility scores', 'Mean and median utility scores']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",69.0,0.177992,"Participants with higher levels of pain (<4/10: 0.741, 95% CI: 0.501-0.980; 4-7/10: 0.572, 0.500-0.644; >7/10: 0.433, 0.347-0.518) or pain interference on function (<4/10: 0.685, 95% CI: 0.605-0.764; 4-7/10: 0.463, 0.394-0.533; >7/10: 0.294, 0.126-0.463) presented significantly lower utility scores.","[{'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Gagnon', 'Affiliation': 'Centre for Interdisciplinary Research in Rehabilitation and Social Integration (Cirris), Centre intégré universitaire de santé et de services sociaux (CIUSSS) de La Capitale-Nationale, Quebec City, Quebec, Canada.'}, {'ForeName': 'Kadija', 'Initials': 'K', 'LastName': 'Perreault', 'Affiliation': 'Centre for Interdisciplinary Research in Rehabilitation and Social Integration (Cirris), Centre intégré universitaire de santé et de services sociaux (CIUSSS) de La Capitale-Nationale, Quebec City, Quebec, Canada.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Guertin', 'Affiliation': 'Department of Social and Preventive Medicine, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Berthelot', 'Affiliation': 'Centre de recherche du CHU de Québec - Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Achou', 'Affiliation': 'HEC Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Luc J', 'Initials': 'LJ', 'LastName': 'Hébert', 'Affiliation': 'Centre for Interdisciplinary Research in Rehabilitation and Social Integration (Cirris), Centre intégré universitaire de santé et de services sociaux (CIUSSS) de La Capitale-Nationale, Quebec City, Quebec, Canada.'}]",ClinicoEconomics and outcomes research : CEOR,['10.2147/CEOR.S348138']
2620,35221689,Quality of Life (QoL) Assessment in the Patients Operated with Either Laparoscopic or an Open Aortobifemoral Bypass for Aortoiliac Occlusive Disease (AIOD): 2 Years Results of a Randomized Controlled Trial.,"Background


QoL assessment within surgical treatment is seldom investigated and sparsely reported in the medical literature. This study aimed to compare QoL in a randomized fashion in the patients treated with either a laparoscopic aortobifemoral bypass (LABFB) or an open aortobifemoral bypass (OABFB) for the treatment of AIOD.
Patients and Methods


Seventy-one consecutive patients with AIOD, Trans-Atlantic Inter-Society Consensus II Type D lesions (TASC II, Type D) were randomized to LABFB or OABFB. Thirty-five patients in the LABFB and thirty-six in the OABFB groups were compared for the changes in the QoL, with the short-form health survey (SF-36), EuroQol 5 dimensions (EQ-5D), and EQ-5D visual analog scale (VAS) preoperatively, and postoperatively at 1, 3, 6, 12 and 24 months. Mann-Whitney  U -Test and Wilcoxon sign-rank test were used for group comparison. Mixed model analysis was performed to examine the effect of different variables on the QoL.
Results


In the patients treated with LABFB, physical component score (PCS) and mental component score (MCS) in SF-36 were significantly higher than OABFB, at 1 and 3 months postoperatively. PCS was also significantly higher in the LABFB group than OABFB at 24 months postoperatively. The preoperative QoL scores for both the laparoscopy and the open group were significantly lower than the age-matched general Norwegian population. EQ-5D median scores were significantly higher in the LABFB at all postoperative follow-up time points up to 12 months. The patients in the LABFB group also had a statistically significant increase in EQ-5D VAS compared to OABFB, at 1 and 12 months postoperatively (p = 0.005, and p = 0.037, respectively).
Conclusion


QoL seems better in patients treated with LABFB than OABFB, particularly during the early months after surgery.",2022,The preoperative QoL scores for both the laparoscopy and the open group were significantly lower than the age-matched general Norwegian population.,"['patients treated with either a', 'Patients and Methods\n\n\nSeventy-one consecutive patients with AIOD, Trans-Atlantic Inter-Society Consensus II Type D lesions (TASC II, Type D', 'Patients Operated with Either Laparoscopic or an Open Aortobifemoral Bypass for Aortoiliac Occlusive Disease (AIOD']","['LABFB', 'LABFB or OABFB', 'laparoscopic aortobifemoral bypass (LABFB) or an open aortobifemoral bypass (OABFB']","['short-form health survey (SF-36), EuroQol 5 dimensions (EQ-5D), and EQ-5D visual analog scale (VAS', 'preoperative QoL scores', 'PCS', 'EQ-5D median scores', 'LABFB, physical component score (PCS) and mental component score (MCS) in SF-36', 'EQ-5D VAS', 'Quality of Life (QoL) Assessment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C1306762', 'cui_str': 'Aorto-iliac disease'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}]",71.0,0.015457,The preoperative QoL scores for both the laparoscopy and the open group were significantly lower than the age-matched general Norwegian population.,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Sahba', 'Affiliation': 'Department of Vascular Surgery, Østfold Central Hospital, Kalnes, Norway.'}, {'ForeName': 'Anne Helene', 'Initials': 'AH', 'LastName': 'Krog', 'Affiliation': 'Department of Vascular Surgery, Østfold Central Hospital, Kalnes, Norway.'}, {'ForeName': 'Erik Mulder', 'Initials': 'EM', 'LastName': 'Pettersen', 'Affiliation': 'Department of Vascular Surgery, Sørlandet Hospital HF, Kristiansand, Norway.'}, {'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Wisløff', 'Affiliation': 'Health Services Research Unit, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Jon Otto', 'Initials': 'JO', 'LastName': 'Sundhagen', 'Affiliation': 'Department of Vascular Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Ullevål, Oslo, Norway.'}, {'ForeName': 'Syed Sajid Hussain', 'Initials': 'SSH', 'LastName': 'Kazmi', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}]",Vascular health and risk management,['10.2147/VHRM.S350836']
2621,35221687,Therapeutic Potential of Vortioxetine for Anhedonia-Like Symptoms in Depression: A Post Hoc Analysis of Data from a Clinical Trial Conducted in Japan.,"Aim


Anhedonia in major depressive disorder may be resistant to first-line antidepressants. We examined the effect of vortioxetine, a multimodal antidepressant, on anhedonia-like symptoms in Japanese patients with major depressive disorder.
Methods


This was a post hoc analysis of an 8-week, randomized, double-blind, placebo-controlled, phase 3 study of vortioxetine (10 mg or 20 mg) in Japanese patients aged 20-75 years with recurrent major depressive disorder and a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of at least 26. The primary outcome was the mean change from baseline to week 8 in anhedonia-like symptoms as measured by MADRS anhedonia factor score, composed of: Q1, apparent sadness; Q2, reported sadness; Q6, concentration; Q7, lassitude; and Q8, inability to feel. Mean change in MADRS total score and anhedonia factor score were compared among treatment groups, with data categorized by median baseline anhedonia factor score (0-17 or ≥18).
Results


Data were available for 489 patients. The least-squares mean difference in MADRS anhedonia factor score change from baseline to week 8 versus placebo was -1.34 for vortioxetine 10 mg ( P  = 0.0300) and -1.77 for vortioxetine 20 mg ( P  = 0.0044). The least-squares mean difference between vortioxetine and placebo in MADRS total score change from baseline to week 8 was -3.11 (10 mg dose) and -3.37 (20 mg dose) for patients with a higher baseline anhedonia factor score (≥18), and -2.08 (10 mg) and -2.61 (20 mg) for patients with a lower baseline score (0-17).
Conclusion


This post hoc analysis suggests that vortioxetine may have therapeutic potential in patients with anhedonia-like symptoms of major depressive disorder. ClinicalTrials.gov identifier for primary study: NCT02389816.",2022,The least-squares mean difference in MADRS anhedonia factor score change from baseline to week 8 versus placebo was -1.34 for vortioxetine 10 mg ( P  = 0.0300) and -1.77 for vortioxetine 20 mg ( P  = 0.0044).,"['Japanese patients with major depressive disorder', '489 patients', 'Depression', 'patients with anhedonia-like symptoms of major depressive disorder', 'Japanese patients aged 20-75 years with recurrent major depressive disorder and a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of at least 26']","['vortioxetine and placebo', 'Vortioxetine', 'placebo', 'vortioxetine']","['mean change from baseline to week 8 in anhedonia-like symptoms as measured by MADRS anhedonia factor score, composed of: Q1, apparent sadness; Q2, reported sadness; Q6, concentration; Q7, lassitude; and Q8, inability to feel', 'anhedonia-like symptoms', 'MADRS total score change', 'MADRS anhedonia factor score change', 'baseline anhedonia factor score', 'Mean change in MADRS total score and anhedonia factor score']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0086525', 'cui_str': 'Lassitude'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.432144,The least-squares mean difference in MADRS anhedonia factor score change from baseline to week 8 versus placebo was -1.34 for vortioxetine 10 mg ( P  = 0.0300) and -1.77 for vortioxetine 20 mg ( P  = 0.0044).,"[{'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Neuropsychiatry, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Fujimoto', 'Affiliation': 'Japan Medical Office, Takeda Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Marumoto', 'Affiliation': 'Japan Medical Office, Takeda Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Tadayuki', 'Initials': 'T', 'LastName': 'Kitagawa', 'Affiliation': 'Takeda Development Center - Japan, Takeda Pharmaceutical Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Ishida', 'Affiliation': 'Takeda Development Center - Japan, Takeda Pharmaceutical Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Japan Medical Office, Takeda Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Moriguchi', 'Affiliation': 'Medical Affairs, Lundbeck Japan K.K., Tokyo, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Fujikawa', 'Affiliation': 'Japan Medical Office, Takeda Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Psychiatry, Tokyo Medical University, Tokyo, Japan.'}]",Neuropsychiatric disease and treatment,['10.2147/NDT.S340281']
2622,35224425,A Smartphone Application as an Exploratory Endpoint in a Phase 3 Parkinson's Disease Clinical Trial: A Pilot Study.,"Background


Smartphones can generate objective measures of Parkinson's disease (PD) and supplement traditional in-person rating scales. However, smartphone use in clinical trials has been limited.
Objective


This study aimed to determine the feasibility of introducing a smartphone research application into a PD clinical trial and to evaluate the resulting measures.
Methods


A smartphone application was introduced part-way into a phase 3 randomized clinical trial of inosine. The application included finger tapping, gait, and cognition tests, and participants were asked to complete an assessment battery at home and in clinic alongside the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
Results


Of 236 eligible participants in the parent study, 88 (37%) consented to participate, and 59 (27 randomized to inosine and 32 to placebo) completed a baseline smartphone assessment. These 59 participants collectively completed 1,292 batteries of assessments. The proportion of participants who completed at least one smartphone assessment was 61% at 3, 54% at 6, and 35% at 12 months. Finger tapping speed correlated weakly with the part III motor portion ( r  = -0.16, left hand;  r  = -0.04, right hand) and total ( r  = -0.14) MDS-UPDRS. Gait speed correlated better with the same measures ( r  = -0.25, part III motor;  r  = -0.34, total). Over 6 months, finger tapping speed, gait speed, and memory scores did not differ between those randomized to active drug or placebo.
Conclusions


Introducing a smartphone application midway into a phase 3 clinical trial was challenging. Measures of bradykinesia and gait speed correlated modestly with traditional outcomes and were consistent with the study's overall findings, which found no benefit of the active drug.",2022,"Over 6 months, finger tapping speed, gait speed, and memory scores did not differ between those randomized to active drug or placebo.
","[""a Phase 3 Parkinson's Disease Clinical Trial"", '236 eligible participants in the parent study, 88 (37%) consented to participate, and 59 (27 randomized to inosine and 32 to', '59 participants collectively completed 1,292 batteries of assessments']",['placebo'],"['Finger tapping speed', 'bradykinesia and gait speed', ""Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS"", 'finger tapping speed, gait speed, and memory scores', 'Gait speed']","[{'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0021528', 'cui_str': 'Inosine'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",236.0,0.244753,"Over 6 months, finger tapping speed, gait speed, and memory scores did not differ between those randomized to active drug or placebo.
","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Page', 'Affiliation': 'Center for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Yung', 'Affiliation': 'Center for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Auinger', 'Affiliation': 'Center for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Venuto', 'Affiliation': 'Center for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Glidden', 'Affiliation': 'Center for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Macklin', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Larsson', 'Initials': 'L', 'LastName': 'Omberg', 'Affiliation': 'Sage Bionetworks, Seattle, Washington, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Schwarzschild', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'E Ray', 'Initials': 'ER', 'LastName': 'Dorsey', 'Affiliation': 'Center for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA.'}]",Digital biomarkers,['10.1159/000521232']
2623,35224416,Recombinant single-chain factor VIII in severe hemophilia: Long-term safety and efficacy in previously treated patients in the AFFINITY extension study.,"Background


rVIII-SingleChain is a recombinant single-chain factor VIII used to treat people with hemophilia A.
Objectives


The aim of this extension study was to investigate the long-term safety and efficacy of rVIII-SingleChain prophylaxis in ≥200 previously treated patients (PTPs) with hemophilia A with ≥100 exposure days (EDs).
Methods


In total, 222 patients were enrolled, of which 204 rolled over from prior rVIII-SingleChain studies. The median age was 21 years (range, 2-65 years), including 155 patients ≥12 years and 67 patients <12 years. Patients continued with their previously assigned dose and regimen, or switched at the investigator's discretion. Patients were treated for a mean duration of 31 months (range, 1-47 months), the mean ED was 342 (standard deviation, 135.5), and 212 (95.5%) patients achieved >100 EDs. When the study ended, most patients were on either a prophylaxis regimen of 34.9 (17-62) IU/kg, 3×/week (N = 88; 39.6%), or 37.2 (13-65) IU/kg, 2×/week regimen (N = 72; 32.4%).
Results


Hemostatic efficacy was rated excellent or good in 87.1% of assessed bleeds. The median (range) annualized bleeding rate was 1.21 (0.0-42.6), and the annualized spontaneous bleeding rate (AsBR) was 0.32 (0.0-33.0) for prophylaxis regimens. Median AsBR was similar for patients treated 3×/week and 2×/week (0.31 and 0.30, respectively). Surgical hemostatic efficacy was rated excellent or good in 100% of surgeries. No inhibitors, anaphylactic reactions, or thromboembolic events were reported in PTPs.
Conclusion


These results confirm the safety and efficacy of rVIII-SingleChain as a long-term prophylaxis treatment modality for PTPs with severe hemophilia A.",2022,"No inhibitors, anaphylactic reactions, or thromboembolic events were reported in PTPs.
","['severe hemophilia', 'The median age was 21\xa0years (range, 2-65\xa0years), including 155 patients ≥12\xa0years and 67 patients <12\xa0years', '≥200 previously treated patients (PTPs) with hemophilia A with ≥100 exposure days (EDs', 'people with hemophilia A.\nObjectives', 'PTPs with severe hemophilia A', '222 patients were enrolled, of which 204 rolled over from prior rVIII-SingleChain studies']","['rVIII-SingleChain prophylaxis', 'rVIII-SingleChain', 'Recombinant single-chain factor VIII']","['Median AsBR', 'median (range) annualized bleeding rate', 'No inhibitors, anaphylactic reactions, or thromboembolic events', 'Surgical hemostatic efficacy', 'Hemostatic efficacy', 'annualized spontaneous bleeding rate (AsBR']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}, {'cui': 'C0543436', 'cui_str': 'Does roll over'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",222.0,0.0531439,"No inhibitors, anaphylactic reactions, or thromboembolic events were reported in PTPs.
","[{'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Mahlangu', 'Affiliation': 'University of the Witwatersrand NHLS and Charlotte Maxeke Hospital Johannesburg South Africa.'}, {'ForeName': 'Faraizah', 'Initials': 'F', 'LastName': 'Abdul Karim', 'Affiliation': 'National Blood Centre Kuala Lumpur Malaysia.'}, {'ForeName': 'Oleksandra', 'Initials': 'O', 'LastName': 'Stasyshyn', 'Affiliation': 'Institute of Blood Pathology and Transfusion Medicine National Academy of Medical Sciences of Ukraine Lviv Ukraine.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Korczowski', 'Affiliation': 'Department of Pediatrics Regional Hospital University of Rzeszów Rzeszów Poland.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Salazar', 'Affiliation': 'CSL Behring King of Prussia Pennsylvania USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Lucas', 'Affiliation': 'CSL Behring King of Prussia Pennsylvania USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Suen', 'Affiliation': 'CSL Behring King of Prussia Pennsylvania USA.'}, {'ForeName': 'Brahm', 'Initials': 'B', 'LastName': 'Goldstein', 'Affiliation': 'CSL Behring King of Prussia Pennsylvania USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chung', 'Affiliation': 'CSL Behring King of Prussia Pennsylvania USA.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Pabinger', 'Affiliation': 'Clinical Division of Haematology and Haemostaseology Medical Clinic I Medical University Vienna Vienna Austria.'}]",Research and practice in thrombosis and haemostasis,['10.1002/rth2.12665']
2624,35224731,Effect of different surface treatments on the microhardness and color change of artificial enamel lesions.,"BACKGROUND


To investigate the effect of three different surface treatments on the microhardness and color change of artificial enamel lesions.
MATERIALS AND METHODS


One hundred bovine teeth were randomly assigned into four groups. Artificial enamel lesions were created using demineralizing solution for all groups except the sound enamel group. Different surface treatments were then performed G1: resin-infiltrant; G2: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP); G3: artificial saliva; G4: Sound Enamel. Each group was subdivided into three subgroups, where each subgroup was subjected to a different testing method. Subgroup 1: surface microhardness; subgroup 2: cross-sectional microhardness; subgroup 3: color measurement. Statistical analysis was performed by ANOVA, followed by Tukey's post-hoc test.
RESULTS


Sound enamel group recorded the highest surface and cross-sectional microhardness results. No significant difference was found between the resin-infiltrant group and CPP-ACP regarding surface and cross-sectional microhardness at different lesion depths. Resin-infiltrant group showed the least color change (∆E) results compared to the other groups.
CONCLUSION


Resin-infiltrant can effectively enhance surface microhardness and enamel resistance to demineralization, additionally, reduce the staining susceptibility of white spot lesions (WSLs) after treatment. CPP-ACP application for four weeks seems to improve surface microhardness; however, has a limited effect in resisting staining of WSLs after treatment. © 2022 Australian Dental Association.",2022,No significant difference was found between the resin-infiltrant group and CPP-ACP regarding surface and cross-sectional microhardness at different lesion depths.,"['© 2022 Australian Dental Association', 'One hundred bovine teeth']","['G1: resin-infiltrant; G2', 'Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP', 'CPP-ACP']","['surface microhardness', 'least color change (∆E', 'microhardness and color change of artificial enamel lesions']","[{'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0475330', 'cui_str': 'Color change'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",100.0,0.0363367,No significant difference was found between the resin-infiltrant group and CPP-ACP regarding surface and cross-sectional microhardness at different lesion depths.,"[{'ForeName': 'Aliaa H', 'Initials': 'AH', 'LastName': 'Ayad', 'Affiliation': 'Operative Dentistry Department, Faculty of Dentistry, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Marwa I', 'Initials': 'MI', 'LastName': 'AbdelHafez', 'Affiliation': 'Operative Dentistry Department, Faculty of Dentistry, NewGiza University, Giza, Egypt.'}, {'ForeName': 'Rasha N', 'Initials': 'RN', 'LastName': 'AlGhandour', 'Affiliation': 'Operative Dentistry Department, Faculty of Dentistry, Egyptian Russian University, Cairo, Egypt.'}, {'ForeName': 'Dena S', 'Initials': 'DS', 'LastName': 'Mustafa', 'Affiliation': 'Operative Dentistry Department, Faculty of Dentistry, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Khaled A', 'Initials': 'KA', 'LastName': 'Nour', 'Affiliation': 'Operative Dentistry Department, Faculty of Dentistry, Ain Shams University, Cairo, Egypt.'}]",Australian dental journal,['10.1111/adj.12908']
2625,35224875,"Laparoscopic Glissonian pedicle versus hilar dissection approach hemihepatectomy: A prospective, randomized controlled trial.","PURPOSE


This over 7-year case study is the first to compare the results of laparoscopic Glissonian pedicle approach hemihepatectomy (LGAH) and laparoscopic hilar dissection approach hemihepatectomy (LHAH) in a randomized controlled trial (RCT).
METHODS


Patients who had undergone laparoscopic hemihepatectomy, either LGAH or LHAH, between March 2012 and December 2019 at our center were prospectively enrolled and assigned to the LGAH or LHAH group. Both groups were stratified and compared, and the preoperative and follow-up outcomes were analyzed. The primary endpoints was total operative time.
RESULTS


The groups were equally matched for age, sex, HBsAg, Child-Pugh class, benign disease, malignancy, liver cirrhosis, tumor diameter and type of resection. Ninety-six patients had undergone LGAH and 94 had undergone LHAH. No preoperative death occurred in the two groups. LGAH did not enhance the postoperative overall complication rates (P = 0.465) or intraoperative blood loss (P = 0.535) compared with LHAH. However, the overall operative time (P = 0.014) and hilar dissection time (P = 0.000) were significantly shorter in the LGAH group than in the LHAH group. No significant differences were found between the groups regarding the 1-year (P = 0.384), 3-year (P = 0.332), and 5-year overall survival rates (P = 0.662) or 1-year (P = 0.856), 3-year (P = 0.348), and 5-year disease-free survival rates (P = 0.573).
CONCLUSIONS


LGAH and LHAH are both effective procedures for treating the hilar structures in selected patients. LGAH has advantages over LHAH in reducing total operation time under the condition where both procedures can be used. LGAH for selected patients is worthy of promotion owing to its simplicity and convenience.",2022,LGAH did not enhance the postoperative overall complication rates (P = 0.465) or intraoperative blood loss (P = 0.535) compared with LHAH.,"['Ninety-six patients had undergone LGAH and 94 had undergone LHAH', 'Patients who had undergone laparoscopic hemihepatectomy, either LGAH or LHAH, between March 2012 and December 2019 at our center']","['LHAH', 'Laparoscopic Glissonian pedicle versus hilar dissection approach hemihepatectomy', 'LGAH and LHAH', 'LGAH', 'laparoscopic Glissonian pedicle approach hemihepatectomy (LGAH) and laparoscopic hilar dissection approach hemihepatectomy (LHAH', 'LGAH or LHAH']","['postoperative overall complication rates', 'intraoperative blood loss', 'total operation time', 'hilar dissection time', 'overall operative time', '5-year overall survival rates', 'total operative time', '5-year disease-free survival rates', 'preoperative death']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0456605', 'cui_str': 'Pedicle'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C4087350', 'cui_str': 'Hemihepatectomy'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C4087350', 'cui_str': 'Hemihepatectomy'}, {'cui': 'C0456605', 'cui_str': 'Pedicle'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.122866,LGAH did not enhance the postoperative overall complication rates (P = 0.465) or intraoperative blood loss (P = 0.535) compared with LHAH.,"[{'ForeName': 'Ke-Xi', 'Initials': 'KX', 'LastName': 'Liao', 'Affiliation': 'Institute of Hepatobiliary Surgery, First Affiliated Hospital, Army Medical University, Gaotanyan Road 30, Shapingba District, Chongqing, 400038, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'Institute of Hepatobiliary Surgery, First Affiliated Hospital, Army Medical University, Gaotanyan Road 30, Shapingba District, Chongqing, 400038, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Institute of Hepatobiliary Surgery, First Affiliated Hospital, Army Medical University, Gaotanyan Road 30, Shapingba District, Chongqing, 400038, China.'}, {'ForeName': 'Bao-Lin', 'Initials': 'BL', 'LastName': 'Wang', 'Affiliation': 'Institute of Hepatobiliary Surgery, First Affiliated Hospital, Army Medical University, Gaotanyan Road 30, Shapingba District, Chongqing, 400038, China.'}, {'ForeName': 'Xue-Song', 'Initials': 'XS', 'LastName': 'Li', 'Affiliation': 'Institute of Hepatobiliary Surgery, First Affiliated Hospital, Army Medical University, Gaotanyan Road 30, Shapingba District, Chongqing, 400038, China.'}, {'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': 'Institute of Hepatobiliary Surgery, First Affiliated Hospital, Army Medical University, Gaotanyan Road 30, Shapingba District, Chongqing, 400038, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Li', 'Affiliation': 'Institute of Hepatobiliary Surgery, First Affiliated Hospital, Army Medical University, Gaotanyan Road 30, Shapingba District, Chongqing, 400038, China.'}, {'ForeName': 'Yu-Dong', 'Initials': 'YD', 'LastName': 'Fan', 'Affiliation': 'Institute of Hepatobiliary Surgery, First Affiliated Hospital, Army Medical University, Gaotanyan Road 30, Shapingba District, Chongqing, 400038, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Institute of Hepatobiliary Surgery, First Affiliated Hospital, Army Medical University, Gaotanyan Road 30, Shapingba District, Chongqing, 400038, China.'}, {'ForeName': 'Shu-Guo', 'Initials': 'SG', 'LastName': 'Zheng', 'Affiliation': 'Institute of Hepatobiliary Surgery, First Affiliated Hospital, Army Medical University, Gaotanyan Road 30, Shapingba District, Chongqing, 400038, China.'}]",Journal of hepato-biliary-pancreatic sciences,['10.1002/jhbp.1129']
2626,35224871,Irisin response to acute moderate intensity exercise and high intensity interval training in youth of different obesity statuses: A randomized crossover trial.,"Limited data exist regarding the impact of an acute bout of exercise with varying intensities on irisin levels in the youth of different obesity statuses. The objectives were to (1) compare an acute bout of moderate continuous intensity (MCI) exercise and an acute bout of high-intensity interval training (HIIT) on irisin response in youth with different obesity statuses and, (2) investigate whether changes in irisin levels are correlated with exploratory outcomes. A randomized crossover design study was conducted on 25 youth aged 12-18 years old. Participants were classified as either healthy weight (BMI percentile <85; n = 14) or overweight/obese (BMI percentile ≥85; n = 11). Participants performed an MCI exercise session at 50% of heart rate reserve for 35 min and a HIIT exercise session for 35 min, with intervals every 5 min increasing from 50% heart rate reserve to 85-90% for 2 min. Irisin was measured using an enzyme-linked immunoabsorbent assay from plasma sampling obtained throughout the exercise (at times 0, 7, 14, 21, 28, and 35 min). A time effect was observed throughout the HIIT session [F(1,5) = 6.478, p < 0.001]. Bonferonni post-hoc analysis revealed significant differences in irisin levels post-exercise (35 min) compared to times 7, 14, 21, and 28 min. Irisin increased during HIIT (81.0% ± 71.3; p = 0.012) in youth with a healthy weight. No differences were observed for youth living as overweight or with obesity. Overall, HIIT elicits a higher peak irisin response compared to MCI exercise training in youth.",2022,Irisin increased during HIIT (81.0% ± 71.3; p = 0.012) in youth with a healthy weight.,"['25 youth aged 12-18\xa0years old', 'Participants were classified as either healthy weight (BMI percentile\xa0<85; n\xa0=\xa014) or overweight/obese', 'youth of different obesity statuses']","['MCI exercise training', 'acute bout of moderate continuous intensity (MCI) exercise and an acute bout of high-intensity interval training (HIIT', 'MCI exercise session', 'acute moderate intensity exercise and high intensity interval training', 'HIIT exercise session']","['Irisin response', 'youth living as overweight or with obesity', 'irisin levels', 'Irisin', 'peak irisin response', 'irisin levels post-exercise']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}]",25.0,0.0172395,Irisin increased during HIIT (81.0% ± 71.3; p = 0.012) in youth with a healthy weight.,"[{'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Colpitts', 'Affiliation': 'Cardiometabolic Exercise & Lifestyle Laboratory, University of New Brunswick, Fredericton, New Brunswick, Canada.'}, {'ForeName': 'Brittany V', 'Initials': 'BV', 'LastName': 'Rioux', 'Affiliation': 'Cardiometabolic Exercise & Lifestyle Laboratory, University of New Brunswick, Fredericton, New Brunswick, Canada.'}, {'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Eadie', 'Affiliation': 'Dalhousie Medicine New Brunswick, Faculty of Medicine, Department of Pharmacology, Dalhousie University, Saint John, New Brunswick, Canada.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Brunt', 'Affiliation': 'Dalhousie Medicine New Brunswick, Faculty of Medicine, Department of Pharmacology, Dalhousie University, Saint John, New Brunswick, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sénéchal', 'Affiliation': 'Cardiometabolic Exercise & Lifestyle Laboratory, University of New Brunswick, Fredericton, New Brunswick, Canada.'}]",Physiological reports,['10.14814/phy2.15198']
2627,35224814,Predictors of mortality in subjects with progressive fibrosing interstitial lung diseases.,"BACKGROUND AND OBJECTIVE


Demographic and clinical variables, measured at baseline or over time, have been associated with mortality in subjects with progressive fibrosing interstitial lung diseases (ILDs). We used data from the INPULSIS trials in subjects with idiopathic pulmonary fibrosis (IPF) and the INBUILD trial in subjects with other progressive fibrosing ILDs to assess relationships between demographic/clinical variables and mortality.
METHODS


The relationships between baseline variables and time-varying covariates and time to death over 52 weeks were analysed using pooled data from the INPULSIS trials and, separately, the INBUILD trial using a Cox proportional hazards model.
RESULTS


Over 52 weeks, 68/1061 (6.4%) and 33/663 (5.0%) subjects died in the INPULSIS and INBUILD trials, respectively. In the INPULSIS trials, a relative decline in forced vital capacity (FVC) >10% predicted within 12 months (hazard ratio [HR] 3.77) and age (HR 1.03 per 1-year increase) were associated with increased risk of mortality, while baseline FVC % predicted (HR 0.97 per 1-unit increase) and diffusing capacity of the lungs for carbon monoxide (DLCO) % predicted (HR 0.77 per 1-unit increase) were associated with lower risk. In the INBUILD trial, a relative decline in FVC >10% predicted within 12 months (HR 2.60) and a usual interstitial pneumonia-like fibrotic pattern on HRCT (HR 2.98) were associated with increased risk of mortality, while baseline DLCO % predicted (HR 0.95 per 1-unit increase) was associated with lower risk.
CONCLUSION


These data support similarity in the course of lung injury between IPF and other progressive fibrosing ILDs and the value of FVC decline as a predictor of mortality.",2022,"Over 52 weeks, 68/1061 (6.4%) and 33/663 (5.0%) subjects died in the INPULSIS and INBUILD trials, respectively.","['subjects with progressive fibrosing interstitial lung diseases (ILDs', 'subjects with idiopathic pulmonary fibrosis (IPF) and the INBUILD trial in subjects with other progressive fibrosing ILDs', 'subjects with progressive fibrosing interstitial lung diseases']",[],"['risk of mortality', 'diffusing capacity of the lungs for carbon monoxide (DLCO', 'forced vital capacity (FVC']","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280474', 'cui_str': 'Transfer factor (respiratory measure)'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",,0.329711,"Over 52 weeks, 68/1061 (6.4%) and 33/663 (5.0%) subjects died in the INPULSIS and INBUILD trials, respectively.","[{'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, National Jewish Health, Denver, Colorado, USA.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Japan.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Flaherty', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'National Reference Centre for Rare Pulmonary Diseases, Louis Pradel Hospital, Hospices Civils de Lyon, Claude Bernard University Lyon 1, Lyon, France.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bonella', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Department of Pneumology, Ruhrlandklinik University Hospital, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Cerri', 'Affiliation': 'Center for Rare Lung Disease, Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy.'}, {'ForeName': 'Sonye K', 'Initials': 'SK', 'LastName': 'Danoff', 'Affiliation': 'Johns Hopkins Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Jouneau', 'Affiliation': 'Department of Respiratory Medicine, Competences Centre for Rare Pulmonary Diseases, CHU Rennes, IRSET UMR 1085, Univ Rennes, Rennes, France.'}, {'ForeName': 'Rainer-Georg', 'Initials': 'RG', 'LastName': 'Goeldner', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Stowasser', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Rozsa', 'Initials': 'R', 'LastName': 'Schlenker-Herceg', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA.'}, {'ForeName': 'Athol U', 'Initials': 'AU', 'LastName': 'Wells', 'Affiliation': 'National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and National Heart and Lung Institute, Imperial College, London, UK.'}]","Respirology (Carlton, Vic.)",['10.1111/resp.14231']
2628,35224811,"Effects of a mobile oral care app on oral mucositis, pain, nutritional status, and quality of life in patients with head and neck cancer: A quasi-experimental study.","AIM


The aim of this work is to explore the effectiveness of a mobile app to support oral mucositis care to improve the nutritional status and reduce the occurrence of oral mucositis of patients with head and neck cancer undergoing concurrent chemoradiotherapy.
BACKGROUND


Concurrent chemoradiotherapy is the optimal treatment for head and neck cancer, but oral mucositis and malnutrition are common complications.
DESIGN


Quasi-experimental study using a pre-post design was used in this work.
METHOD


Participants were recruited from a major regional hospital in Taiwan from July 2018 to July 2020. There were 32 participants in each group: the mobile app group (Intervention Group) or routine care (Control Group). The primary outcome measure was Patient-Generated Subjective Global Assessment (PG-SGA). We also collected data on grade of oral mucositis, painNnumeric Rating Scale (NRS), weight loss, haemoglobin (Hb), albumin and quality of life (QoL).
RESULT


The PG-SGA score was significantly lower in the intervention than the control group at all three time points. Hb and albumin decreased less significantly in the intervention than the control group after 2 months. The oral mucositis grade was significantly less severe in the intervention than the control group at all three time points; for the NRS, at T2 and T3.
CONCLUSION


Using the mobile app effectively improved nutritional status, alleviated the side effects, and improved the QoL of head and neck cancer patients with concurrent chemoradiotherapy.",2022,"The oral mucositis grade was significantly less severe in the intervention than the control group at all three time points; for the NRS, at T2 and T3.
","['Participants were recruited from a major regional hospital in Taiwan from July 2018 to July 2020', 'patients with head and neck cancer', 'patients with head and neck cancer undergoing concurrent chemoradiotherapy', 'head and neck cancer']","['mobile app group (Intervention Group) or routine care (Control Group', 'chemoradiotherapy', 'mobile oral care app']","['oral mucositis grade', 'side effects', 'grade of oral mucositis, painNnumeric Rating Scale (NRS), weight loss, haemoglobin (Hb), albumin and quality of life (QoL', 'Hb and albumin', 'PG-SGA score', 'Patient-Generated Subjective Global Assessment (PG-SGA', 'oral mucositis, pain, nutritional status, and quality of life', 'nutritional status', 'oral mucositis']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}]",,0.047235,"The oral mucositis grade was significantly less severe in the intervention than the control group at all three time points; for the NRS, at T2 and T3.
","[{'ForeName': 'Tzu-Hsuan', 'Initials': 'TH', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Hsinchu Mackay Memorial Hospital, Hsinchu, Taiwan.'}, {'ForeName': 'Yu-Ming', 'Initials': 'YM', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology, Chung Shan Medical University, Clinical Psychological Room, Chung Shan Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Cheng-Yi', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': 'Department of Nursing, Chung Shan Medical University, Taichung, Taiwan.'}]",International journal of nursing practice,['10.1111/ijn.13042']
2629,35224774,Five-year randomized controlled clinical study comparing cemented and screw-retained zirconia-based implant-supported single crowns.,"OBJECTIVES


To compare screw-retained and cemented all-ceramic implant-supported single crowns regarding biological and technical outcomes over a 5-year observation period.
MATERIALS AND METHODS


In 44 patients, 44 two-piece dental implants were placed in single-tooth gaps in the esthetic zone. Patients randomly received a screw-retained (SR) or cemented (CR) all-ceramic single crown and were then re-examined annually up to 5 years. Outcome measures included: clinical, biological, technical, and radiographic parameters. Data were statistically analyzed with Wilcoxon-Mann-Whitney, Wilcoxon, and Fisher's exact tests.
RESULTS


During the observation period, three patients (6.8%) were loss to follow-up. Eight restorations (18.2%, CI (8.2%, 32.7%)) were lost due to technical (6 patients, 13.6% (CI (5.2%, 27.4%)), 2 CR and 4 SR group, intergroup p = .673; implants still present) or biological complications (2 patients, 4.5% (CI (0.6%, 16.5%)), only CR group, intergroup p = .201, both implants lost). This resulted in a survival rate of 81.2% (CI (65.9%, 90.1%)) on the restorative level (18 SR; 15 CR, 3 lost to follow-up). At the 5-year follow-up, the median marginal bone levels were located slightly apical relative to the implant shoulder with 0.4 mm (0.5; 0.3) (SR) and 0.4 mm (0.8; 0.3) (CR) (intergroup p = .582). Cemented restorations demonstrated a significantly higher biological complication rate (36.8%, SR: 0.0%; intergroup p = .0022), as well as a significantly higher overall complication rate (68.4%, SR: 22.7%, intergroup p = .0049). All other outcomes did not differ significantly between the two groups (p > .05).
CONCLUSIONS


All-ceramic single-tooth restorations on two-piece dental implants resulted in a relatively low survival rate. Cemented restorations were associated with a higher biological and overall complication rate than screw-retained restorations.",2022,"Cemented restorations demonstrated a significantly higher biological complication rate (36.8%, SR 0.0%; intergroup p=0.0022), as well as a significantly higher overall complication rate (68.4%, SR 22.7%, intergroup p=0.0049).","['in 44 patients, 44 two-piece dental implants were placed in single tooth gaps in the esthetic zone']","['screw-retained (SR) or cemented (CR) all-ceramic single crown', 'cemented and screw-retained zirconia-based implant-supported single crowns', 'screw-retained and cemented all-ceramic implant-supported single crowns']","['restorative level', 'biological complication rate', 'survival rate', 'overall complication rate', 'low survival rate', 'median marginal bone levels', ' clinical, biological, technical and radiographic parameters', 'biological complications', 'higher biological and overall complication rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}]","[{'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High'}]",44.0,0.13926,"Cemented restorations demonstrated a significantly higher biological complication rate (36.8%, SR 0.0%; intergroup p=0.0022), as well as a significantly higher overall complication rate (68.4%, SR 22.7%, intergroup p=0.0049).","[{'ForeName': 'Riccardo D', 'Initials': 'RD', 'LastName': 'Kraus', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Espuelas', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christoph H F', 'Initials': 'CHF', 'LastName': 'Hämmerle', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Jung', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Sailer', 'Affiliation': 'Division of Fixed Prosthodontics and Biomaterials, University Clinics for Dental Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Thoma', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}]",Clinical oral implants research,['10.1111/clr.13913']
2630,35225119,"Does dual task merged in a mixed physical exercise protocol impact the mobility under dual task conditions in mild impaired stroke survivors? A feasibility, safety, randomized, and controlled pilot trial.","PURPOSE


To investigate the feasibility, safety, and effects of dual task (DT) in a mixed physical exercise protocol on mobility under DT in stroke survivors.
MATERIALS AND METHODS


Twenty-six chronic mild-impaired stroke survivors (age 51.57 ± 12.55; men= 13, women= 13) were randomly assigned into Experimental Group participating in a 15-week mixed (aerobic and resistance exercises performing a cognitive DT condition simultaneously) physical exercise protocol (30 sessions, 2x/week, duration of 60-90 min), and Control Group engaged in the same protocol without DT. Feasibility and outcome measures were assessed before and after the intervention and in a 5-week follow-up.
RESULTS


DT physical exercise protocol was viable and safe. This protocol also improved mobility and gait when performed under DT, which was not found in the control group. DT does not influence aerobic resistance, strength, and balance responsiveness. It does not present any improvement in cognition, self-efficacy for falls, and quality of life.
CONCLUSION


The results indicate that mixed physical exercise under DT is feasible and safe for mild-impaired stroke survivors. Stroke survivors demonstrate more significant improvement in the mobility performance under DT when submitted to a DT mixed physical exercise protocol than the standard physical exercise intervention.
TRIAL REGISTRATION


Brazilian clinical trials registry (RBR-4mvzz6); WHO trial record (U1111-1198-7173)IMPLICATIONS FOR REHABILITATIONDT training can be prescribed by using clear and precise parameters for stroke survivors.Physical Exercise without DT requirements did not improve mobility performing and cognitive tasks simultaneously in stroke survivors.Clinicians are encouraged to incorporate DT requirements into the exercise routines to enhance mobility under DT to mild-moderate stroke survivors.",2022,"It does not present any improvement in cognition, self-efficacy for falls, and quality of life.
","['stroke survivors', 'mild impaired stroke survivors', 'Twenty-six chronic mild-impaired stroke survivors (age 51.57\u2009±\u200912.55; men= 13, women= 13']","['dual task (DT', 'Physical Exercise without DT requirements', '15-week mixed (aerobic and resistance exercises performing a cognitive DT condition simultaneously', 'DT mixed physical exercise protocol', 'physical exercise protocol', 'DT physical exercise protocol', 'mixed physical exercise under DT']","['aerobic resistance, strength, and balance responsiveness', 'mobility performing and cognitive tasks', 'cognition, self-efficacy for falls, and quality of life', 'mobility performance', 'mobility and gait']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",26.0,0.0227953,"It does not present any improvement in cognition, self-efficacy for falls, and quality of life.
","[{'ForeName': 'Beatriz de Araujo', 'Initials': 'BA', 'LastName': 'Antonio', 'Affiliation': 'School of Arts, Sciences and Humanities, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Giordano Marcio Gatinho', 'Initials': 'GMG', 'LastName': 'Bonuzzi', 'Affiliation': 'Departament of Physical Education, State University of Piauí, Picos, Brazil.'}, {'ForeName': 'Camilo Motta Pinto', 'Initials': 'CMP', 'LastName': 'Alves', 'Affiliation': 'School of Physical Education and Sport, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Janaine Cunha', 'Initials': 'JC', 'LastName': 'Polese', 'Affiliation': 'Departament of Physical Therapy, Faculty of Medical Sciences of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Mochizuki', 'Affiliation': 'School of Arts, Sciences and Humanities, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Torriani-Pasin', 'Affiliation': 'School of Physical Education and Sport, University of Sao Paulo, Sao Paulo, Brazil.'}]",Disability and rehabilitation,['10.1080/09638288.2022.2043458']
2631,35225115,A Pilot Randomised Controlled Trial Examining the Benefit of a Neutropenic Diet for Children Undergoing Cancer Treatment.,"Neutropenic diet(ND) has been hypothesized to decrease the rate of febrile neutropenia(FN) occurring post-chemotherapy for pediatric cancers. Despite widespread use, it has not shown to be of benefit by randomized controlled trials(RCT) in western countries. No RCT has been conducted in India/LMIC to evaluate its efficacy against the standard Indian diet. Forty-two(42) children, aged 3-14 y, with cancer, scheduled to receive strongly myelosuppressive chemotherapy were randomized to receive either neutropenic diet( n  = 21) or standard Indian diet( n  = 21) for one chemotherapeutic cycle. FN rate was recorded as the primary outcome while the focus of infection, antibiotic length, the requirement for hospital admission, adherence to diet were the secondary outcomes. The groups were similar in baseline characteristics. Twelve patients (57%) in the neutropenic diet and nine patients(43%) in the standard diet arm developed FN. Patients in ND-arm had significantly higher chance of getting neutropenic enterocolitis(NEC) (33.33% vs 4.76%  p  = 0.044). Mortality (14.29%vs 0%,  p  = 0.23) and requirement for admission (47.6%vs 19.05%,  p  = 0.06), was more in the ND-arm but statistically non-significant. There was no significant difference in antibiotic length. Adherence was similar in both groups (95% vs 98%). Neutropenic diet was not effective in reducing FN rate and was associated with higher rate of NEC when compared to the standard diet.",2022,Neutropenic diet was not effective in reducing FN rate and was associated with higher rate of NEC when compared to the standard diet.,"['Children Undergoing Cancer Treatment', 'Forty-two(42) children, aged 3-14\u2009y, with cancer, scheduled to receive strongly myelosuppressive chemotherapy']","['neutropenic diet( n \u2009=\u200921) or standard Indian diet', 'RCT', 'Neutropenic Diet']","['chance of getting neutropenic enterocolitis(NEC', 'antibiotic length', 'FN rate', 'Mortality', 'FN', 'Adherence', 'rate of febrile neutropenia(FN', 'requirement for admission', 'rate of NEC', 'infection, antibiotic length, the requirement for hospital admission, adherence to diet']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0206695', 'cui_str': 'Neuroendocrine carcinoma'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",,0.0501822,Neutropenic diet was not effective in reducing FN rate and was associated with higher rate of NEC when compared to the standard diet.,"[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Aditya Kumar', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Jagdish Prasad', 'Initials': 'JP', 'LastName': 'Meena', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Maroof Ahmad', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Agarwala', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Seth', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}]",Nutrition and cancer,['10.1080/01635581.2022.2044060']
2632,35225112,Therapeutic lumbar puncture and lumbar drainage: which is more effective for the management of intracranial hypertension in HIV patients with cryptococcal meningitis? Results of a prospective non- randomized interventional study in China.,"Objective  This study aimed to evaluate the effectiveness of therapeutic lumbar drainage (LD) compared to therapeutic lumbar puncture (LP) for the management of intracranial hypertension (ICH) among HIV-positive patients with cryptococcal meningitis (CM).  Methods:  The study was a multicenter prospective non-randomized interventional clinical trial. One hundred and sixteen HIV-associated CM patients were identified who presented with ICH (≥250mmH 2 O). The LP group comprised 76 cases, while the LD group consisted of 40 cases. We compared mortality, intracranial pressure (ICP) normalization rate, and clinical symptom remission at 10 weeks, between the two groups.  Results:  The cumulative mortality at week 10 was 22.4% in the LP group and 20% in the LD group ( p  = 0.927), without any significant difference in mortality between the two groups. Improvement after treatment at 2-weeks, ICP normalization, and headache reversal event occurrence in the two groups showed no significant difference ( p  > 0.05). The incidence of CSF  Cryptococcus  clearance at two weeks in the LD group was significantly higher than the LP group ( p  < 0.05). The frequency of invasive lumbar therapeutic procedures in the LP group during the first week was higher than that of the LD group ( p  < 0.05). Localized infection at the puncture site occurred more frequently in the LD group than the LP group ( p  < 0.05).  Conclusion:  For HIV-positive CM patients with an elevated ICP, LD and LP are comparably effective and safe options to normalize ICP. LP increases the frequency of invasive lumbar therapeutic procedures but does not incur more risk of infection events at the puncture site, while LD may accelerate CSF  Cryptococcus  clearance but may induce more frequent localized infection.",2022,Localized infection at the puncture site occurred more frequently in the LD group than the LP group ( p  < 0.05).  ,"['One hundred and sixteen HIV-associated CM patients were identified who presented with ICH (≥250mmH 2 O', 'HIV-positive patients with cryptococcal meningitis (CM', 'HIV patients with cryptococcal meningitis']","['therapeutic lumbar drainage (LD', 'therapeutic lumbar puncture (LP', 'Therapeutic lumbar puncture and lumbar drainage']","['cumulative mortality', 'mortality, intracranial pressure (ICP) normalization rate, and clinical symptom remission', 'Localized infection', 'ICP normalization, and headache reversal event occurrence', 'mortality', 'frequency of invasive lumbar therapeutic procedures', 'incidence of CSF  Cryptococcus  clearance', 'risk of infection events']","[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0085436', 'cui_str': 'Cryptococcal meningitis'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0196309', 'cui_str': 'Therapeutic spinal puncture'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0016397', 'cui_str': 'Localized infection'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0010415', 'cui_str': 'Cryptococcus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",116.0,0.0151087,Localized infection at the puncture site occurred more frequently in the LD group than the LP group ( p  < 0.05).  ,"[{'ForeName': 'Xiao-Lei', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Yan-Qun', 'Initials': 'YQ', 'LastName': 'Huang', 'Affiliation': 'School of Biomedical Engineering, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan-Qiu', 'Initials': 'YQ', 'LastName': 'Lu', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Xue-Jiao', 'Initials': 'XJ', 'LastName': 'He', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Yu-Shan', 'Initials': 'YS', 'LastName': 'Wu', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Yu', 'Affiliation': 'Department of Infectious Diseases, Affiliated Hangzhou Xixi Hospital, Zhejiang University School of Medicine, Zhejiang, China.'}, {'ForeName': 'Tong-Tong', 'Initials': 'TT', 'LastName': 'Yang', 'Affiliation': 'Department of Infectious Disease, Public Health Clinical Center of Chengdu, Sichuan, China.'}, {'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Xu', 'Affiliation': 'National Clinical Research Center for Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Lan', 'Affiliation': 'Division of Infectious Disease, Longtan Hospital of Guangxi Zhuang Autonomous Region, Liuzhou, Guangxi, China.'}, {'ForeName': 'De-Fa', 'Initials': 'DF', 'LastName': 'Zhang', 'Affiliation': ""Infectious Disease Department, Tianjin Second People's Hospital, Tianjin, China.""}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Harypursat', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Yao-Kai', 'Initials': 'YK', 'LastName': 'Chen', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}]",Current medical research and opinion,['10.1080/03007995.2022.2047539']
2633,35225089,EXPRESS: Imagining Emotional Events Benefits Future-Oriented Decisions.,"How does imagining future events - whether positive or negative - influence our choices in the present? Prior work has shown the simulation of hypothetical future events, dubbed episodic future thinking, can alter the propensity to engage in delay discounting (the tendency to devalue future rewards) and does so in a valence specific manner. Some research shows that positive episodic future thinking reduces delay discounting, whereas negative future thinking augments it. However, more recent research indicates that both positive and negative episodic future thinking reduce delay discounting, suggesting an effect of episodic future thinking that is independent of valence (Bulley et al., 2019). In the present study, we sought to replicate and extend these latter findings. Here, participants ( N =604;  N =572 after exclusions) completed an online study. In the baseline task, participants completed a delay discounting task. In the experimental task, they engaged in episodic future thinking before completing a second delay discounting task. Participants were randomly assigned to engage in either positive, neutral, or negative episodic future thinking. In accordance with Bulley et al., we found that episodic future thinking, regardless of valence, reduced delay discounting. Although episodic future thinking shifted decision-making in all conditions, the effect was stronger when participants engaged in positive episodic future thinking, even after accounting for personal relevance and vividness of imagined events. These findings suggest that episodic future thinking may promote future-oriented choices by contextualizing the future, and this effect is further strengthened when the future is tied to positive emotion.",2022,"Although episodic future thinking shifted decision-making in all conditions, the effect was stronger when participants engaged in positive episodic future thinking, even after accounting for personal relevance and vividness of imagined events.",['participants ( N =604;  N =572 after exclusions) completed an online study'],"['positive, neutral, or negative episodic future thinking']",['delay discounting task'],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}]","[{'cui': 'C3850035', 'cui_str': 'Intertemporal Preferences'}]",,0.108786,"Although episodic future thinking shifted decision-making in all conditions, the effect was stronger when participants engaged in positive episodic future thinking, even after accounting for personal relevance and vividness of imagined events.","[{'ForeName': 'Braedon C', 'Initials': 'BC', 'LastName': 'Ballance', 'Affiliation': 'University of British Columbia, Department of Psychology 8166.'}, {'ForeName': 'Young Ji', 'Initials': 'YJ', 'LastName': 'Tuen', 'Affiliation': 'University of British Columbia, Department of Psychology 8166.'}, {'ForeName': 'Aria S', 'Initials': 'AS', 'LastName': 'Petrucci', 'Affiliation': 'University of British Columbia, Department of Psychology 8166.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Orwig', 'Affiliation': 'University of British Columbia, Department of Psychology 1812.'}, {'ForeName': 'Omran K', 'Initials': 'OK', 'LastName': 'Safi', 'Affiliation': 'University of British Columbia, Department of Psychology 8166.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Madan', 'Affiliation': 'University of Nottingham, School of Psychology 6123.'}, {'ForeName': 'Daniela J', 'Initials': 'DJ', 'LastName': 'Palombo', 'Affiliation': 'University of British Columbia, Department of Psychology 8166.'}]",Quarterly journal of experimental psychology (2006),['10.1177/17470218221086637']
2634,35225079,"Concern About Falling, Confidence in Balance, Quality of Life, and Depression Symptoms in Community-Dwelling Older Adults After a 24-week Dual-Task Training With Variable and Fixed Priority: A Randomized Controlled Trial.","OBJECTIVE


To evaluate the effect of a 24-week dual-task training with progression from variable to fixed priority on the concern about falling, confidence in balance, quality of life, and depression symptoms in community-dwelling older adults.
METHODS


A total of 60 participants (60-80 y.o.) were randomly allocated into a dual-task training group with progression from variable to fixed priority (experimental group) or into a dual-task training group with variable priority (control group).
RESULTS


No between-group difference was observed after the intervention. A significant time effect showed a reduction in concern about falling [mean difference (MD) = -2.91)] and depression symptoms (MD = -1.66), an increase in the physical function (MD = 7.86), overall mental health (MD = 5.82), perception of vitality, energy, and less fatigue (MD = 10.45), general perception of overall health (MD = 6.81), and their health compared to the last year (MD = 11.89).
CONCLUSION


The experimental protocol was not superior to the control one. However, both protocols improved these outcomes.",2022,No between-group difference was observed after the intervention.,"['Community-Dwelling Older Adults', '60 participants (60-80 y.o', 'community-dwelling older adults']","['Dual-Task Training With Variable and Fixed Priority', '24-week dual-task training', 'dual-task training group with progression from variable to fixed priority (experimental group) or into a dual-task training group with variable priority (control group']","['physical function (MD = 7.86), overall mental health (MD = 5.82), perception of vitality, energy, and less fatigue (MD = 10.45), general perception of overall health (MD = 6.81), and their health', 'balance, quality of life, and depression symptoms', 'Balance, Quality of Life, and Depression Symptoms']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",60.0,0.0737029,No between-group difference was observed after the intervention.,"[{'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Trombini-Souza', 'Affiliation': 'Department of Physical Therapy, 117113University of Pernambuco, Brazil.'}, {'ForeName': 'Renata Taysa de Souza Azevedo', 'Initials': 'RTSA', 'LastName': 'Nogueira', 'Affiliation': 'Department of Physical Therapy, 117113University of Pernambuco, Brazil.'}, {'ForeName': 'Ana Cícera Batista', 'Initials': 'ACB', 'LastName': 'Serafim', 'Affiliation': 'Department of Physical Therapy, 117113University of Pernambuco, Brazil.'}, {'ForeName': 'Thamires Medeiros Mendes de', 'Initials': 'TMM', 'LastName': 'Lima', 'Affiliation': 'Department of Physical Therapy, 117113University of Pernambuco, Brazil.'}, {'ForeName': 'Michelle Katherine Andrade', 'Initials': 'MKA', 'LastName': 'Xavier', 'Affiliation': 'Physical Therapy course, São Francisco de Juazeiro School, Brazil.'}, {'ForeName': 'Monica Rodrigues', 'Initials': 'MR', 'LastName': 'Perracini', 'Affiliation': ""Master's and Doctoral Programs in Physical Therapy, 149944Universidade Cidade de São Paulo, Brazil.""}, {'ForeName': 'Rodrigo Cappato', 'Initials': 'RC', 'LastName': 'de Araújo', 'Affiliation': 'Department of Physical Therapy, 117113University of Pernambuco, Brazil.'}, {'ForeName': 'Isabel Cn', 'Initials': 'IC', 'LastName': 'Sacco', 'Affiliation': 'School of Medicine, Physical Therapy, Speech and Occupational Therapy Department, 149944Universidade de Sao Paulo, Brazil.'}, {'ForeName': 'Marcelo de Maio', 'Initials': 'MM', 'LastName': 'Nascimento', 'Affiliation': 'Department of Physical Education, Federal University of São Francisco Valley, Petrolina, Brazil.'}]",Research on aging,['10.1177/01640275221073993']
2635,35225519,Comparison of once daily dose of 0.3% nepafenac alone and three times dose of 0.1% nepafenac alone in pain and inflammation control after phacoemulsification.,"Purpose


To compare the efficacy of a once-daily dose of 0.3% nepafenac and three times daily dose of 0.1% nepafenac in controlling pain and inflammation following phacoemulsification.
Methods


In this prospective randomized control single-blind study. patients who underwent uneventful phacoemulsification were divided into two groups. Group A received 0.1% nepafenac eye drops three times/day for 4 weeks and group B received 0.3% nepafenac eye drops once daily for 4 weeks following phacoemulsification. All the patients received moxifloxacin 0.5% eye drops four times/day for 2 weeks. None of the patients in any group received any form of corticosteroids.
Results


The mean age of the patients in group A was 63.55 ± 8.5 years, while in group B, it was 60.05 ± 7.76 years. There was no significant result in the preoperative baseline demographics and intraoperative parameters between both the groups. The results were statistically insignificant in terms of inflammatory markers between both groups on day 1. But, on day 7, group B showed better results in terms of lid edema, conjunctival congestion, and anterior chamber cells. The patients in group B also perceived significantly less pain on day 1 (P = 0.02) and day 7 (P < 0.001). The central macular thickness was also significantly lower in group B at day 30.
(


P < .001) and day 90 (P < .001), respectively.
Conclusion


Once-daily dose of higher concentrated nepafenac (0.3%) is equally effective and shows better results than 0.1% nepafenac for pain and inflammation control.",2022,The patients in group B also perceived significantly less pain on day 1 (P = 0.02) and day 7 (P < 0.001).,['patients who underwent uneventful phacoemulsification'],"['nepafenac eye drops once daily for 4 weeks following phacoemulsification', 'nepafenac alone', 'moxifloxacin', 'nepafenac']","['pain', 'preoperative baseline demographics and intraoperative parameters', 'pain and inflammation', 'inflammatory markers', 'pain and inflammation control', 'lid edema, conjunctival congestion, and anterior chamber cells', 'central macular thickness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}]","[{'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0235263', 'cui_str': 'Conjunctival congestion'}, {'cui': 'C0423282', 'cui_str': 'Anterior chamber cells'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",,0.0314836,The patients in group B also perceived significantly less pain on day 1 (P = 0.02) and day 7 (P < 0.001).,"[{'ForeName': 'Narayan', 'Initials': 'N', 'LastName': 'Bardoloi', 'Affiliation': 'Chandraprabha Eye Hospital, Jorhat, Assam, India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Sarkar', 'Affiliation': 'Chandraprabha Eye Hospital, Jorhat, Assam; Department of Ophthalmology, Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Pankaj Suresh', 'Initials': 'PS', 'LastName': 'Burgute', 'Affiliation': 'Chandraprabha Eye Hospital, Jorhat, Assam, India.'}, {'ForeName': 'Amit Kumar', 'Initials': 'AK', 'LastName': 'Deb', 'Affiliation': 'Department of Ophthalmology, Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Dholkawala', 'Affiliation': 'Chandraprabha Eye Hospital, Jorhat, Assam, India.'}, {'ForeName': 'Priyal', 'Initials': 'P', 'LastName': 'Aggarwal', 'Affiliation': 'Chandraprabha Eye Hospital, Jorhat, Assam, India.'}, {'ForeName': 'Tanmay', 'Initials': 'T', 'LastName': 'Gokhale', 'Affiliation': 'Department of Ophthalmology, Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_2401_21']
2636,35225516,Comparative evaluation of modified crater (endonucleation) chop and conventional crater chop techniques during phacoemulsification of hard nuclear cataracts: A randomized study.,"Purpose


To compare the clinical outcomes of endonucleation chop (EC) versus conventional crater (CC) chop techniques in phacoemulsification of hard nuclear cataracts.
Methods


In this Prospective, longitudinal, randomized controlled study with double-blinding. Hundred consecutive eyes with uncomplicated cataracts (nucleus grades 3 and 4) were equally divided into Group A (EC) and Group B (CC). Intraoperative effective phacoemulsification time (EPT) and balanced salt solution (BSS) volume used was noted. Postoperative central corneal thickness (CCT), endothelial cell density (ECD), uncorrected Visual Acuity (UCVA), best-corrected visual acuity (BCVA), and IOP were recorded at days 1, 7, 30, and 90 postoperatively. The Chi-square test (categorical data), Mann-Whitney U test, and t-tests for other parameters were done.
Results


The mean EPT in Groups A and B were 6.6 and 14.25 s, respectively (P < 0.001). The BSS volume used was 105.9 and 221.7 mL, respectively (P < 0.001). At 3 months, the ECD loss was 4.35 and 8.6%, respectively (P = 0.025). The-first day CCT was significantly increased in Group B but was the same in both groups at 3 months. A significant improvement in BCVA was noted in both groups. This new technique significantly reduces EPT, the BSS used, and ECD loss.
Conclusion


Compared with the CC chop technique, the EC technique for phacoemulsification of hard nuclear cataracts conserved phacoemulsification energy and minimized exposure to the intraocular irrigating solution, provided a significant reduction in corneal endothelial damage, and led to faster visual rehabilitation.",2022,"The BSS volume used was 105.9 and 221.7 mL, respectively (P < 0.001).","['Hundred consecutive eyes with uncomplicated cataracts (nucleus grades 3 and 4', 'phacoemulsification of hard nuclear cataracts']","['Intraoperative effective phacoemulsification time (EPT) and balanced salt solution', 'modified crater (endonucleation) chop and conventional crater chop techniques', 'endonucleation chop (EC) versus conventional crater (CC) chop techniques']","['corneal endothelial damage', 'ECD loss', 'mean EPT', 'BCVA', 'Postoperative central corneal thickness (CCT), endothelial cell density (ECD), uncorrected Visual Acuity (UCVA), best-corrected visual acuity (BCVA), and IOP']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0392557', 'cui_str': 'Nuclear cataract'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C3653289', 'cui_str': 'Salt solutions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}]",0.0,0.0333515,"The BSS volume used was 105.9 and 221.7 mL, respectively (P < 0.001).","[{'ForeName': 'Sukriti', 'Initials': 'S', 'LastName': 'Upadhyay', 'Affiliation': 'Department of Ophthalmology, Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Department of Ophthalmology, Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan, India.'}, {'ForeName': 'Jugal Kishore', 'Initials': 'JK', 'LastName': 'Chouhan', 'Affiliation': 'Department of Ophthalmology, Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Goyal', 'Affiliation': 'Department of Ophthalmology, Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_2172_21']
2637,35225514,Sutureless and glue-free limbal-conjunctival autograft in primary and recurrent pterygium: A pilot study.,"Purpose


To evaluate and analyze the outcomes of sutureless and glue-free limbal-conjunctival autografting in cases of primary as well as recurrent pterygium.
Methods


This prospective interventional study was carried out between February 2019 and February 2020 at a tertiary care hospital in North India. A.
total of 70 patients with pterygium underwent sutureless and glue-free limbal-conjunctival autograft. The patients were divided into two groups: group 1 patients with primary pterygium (n = 45), group 2 patients with recurrent pterygium (n = 25). The patients were followed up till 12 months postoperatively.
Results


The mean age of the patients in group 1 and group 2 was 37.04 ± 8.69 years and 32.52 ± 6.49 years, respectively (P = 0.04). Postoperatively, no recurrence was recorded in group 1. Recurrence was noticed in two patients (8%) of group 2. The BCVA changed from 78.73 ± 9.86 letters to 80.15 ± 7.29 letters (P = 0.45) and from 79.6 ± 6.44 letters to 79.8 ± 5.86 letters (P = 0.45) in group 1 and group 2, respectively. Graft edema was found in seven (15.55%) cases of group 1 and four (16%) cases of group 2. Graft retraction was found in two (4.44%) cases of group 1 and three (12%) cases of group 2.
Conclusion


Sutureless and a glue-free limbal-conjunctival autograft is a safe and effective treatment option for primary as well as recurrent pterygium.",2022,Graft edema was found in seven (15.55%) cases of group 1 and four (16%) cases of group 2.,"['primary and recurrent pterygium', '70 patients with pterygium underwent', 'February 2019 and February 2020 at a tertiary care hospital in North India']","['primary pterygium', 'Sutureless and glue-free limbal-conjunctival autograft', 'sutureless and glue-free limbal-conjunctival autografting', 'Conclusion\n\n\nSutureless and a glue-free limbal-conjunctival autograft', 'sutureless and glue-free limbal-conjunctival autograft']","['Graft retraction', 'Recurrence', 'Graft edema', 'recurrence']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0155158', 'cui_str': 'Recurrent pterygium'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0443251', 'cui_str': 'Limbal'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",70.0,0.0403361,Graft edema was found in seven (15.55%) cases of group 1 and four (16%) cases of group 2.,"[{'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Department of Ophthalmology, AFCME, New Delhi, India.'}, {'ForeName': 'Ankuj', 'Initials': 'A', 'LastName': 'Tinna', 'Affiliation': 'Department of Ophthalmology, INHS Asvini, Mumbai, Maharastra, India.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Ophthalmology, 167 MH, Pathankot, Punjab, India.'}, {'ForeName': 'Atul K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Department of Ophthalmology, AFCME, New Delhi, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Ambiya', 'Affiliation': 'Department of Ophthalmology, Command Hospital, Kolkata, West Bengal, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1895_21']
2638,35225510,Understanding the science of fungal endophthalmitis - AIOS 2021 Sengamedu Srinivas Badrinath Endowment Lecture.,"Fungal endophthalmitis is a potentially blinding condition. It is more often reported from Asia, including India. The incidence is lower than bacterial endophthalmitis. But it is relatively more challenging to treat than bacterial endophthalmitis. Many eyes may need therapeutic keratoplasty and/or evisceration. The current mainstays of treatment are vitrectomy irrespective of the presenting vision, intravitreal antifungal agents, and systemic therapy; additionally, the patients could require prolonged treatment with repeat vitreous surgeries and intravitreal injections. Difficulty in clinical diagnosis, delay in microbiological culture, and limited options of antifungal drugs make the treatment more difficult and less rewarding. Three common fungi causing endophthalmitis are Aspergillus, Fusarium, and Candida. The former two are molds, often identified in exogenous endophthalmitis, postoperative and traumatic; the latter is yeast and is more often identified in endogenous endophthalmitis. A faster diagnosis with newer molecular microbiological technologies might help institute treatment earlier than it is currently possible. A target trial using big data from different regions of the world might emulate a randomized clinical trial to design a definite treatment strategy. Given fewer antifungal drugs, one must be mindful of antifungal stewardship to prevent resistance to the existing drugs.",2022,The incidence is lower than bacterial endophthalmitis.,[],[],[],[],[],[],,0.140038,The incidence is lower than bacterial endophthalmitis.,"[{'ForeName': 'Taraprasad', 'Initials': 'T', 'LastName': 'Das', 'Affiliation': 'Srimati Kanuri Shanthamma Center for Vitreoretinal Diseases, Hyderabad, Telangana, India.'}, {'ForeName': 'Joveeta', 'Initials': 'J', 'LastName': 'Joseph', 'Affiliation': 'Jhaveri Microbiology Center, Hyderabad, Telangana, India.'}, {'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Jakati', 'Affiliation': 'Pathology Laboratory, Kallam Anji Reddy Campus, L V Prasad Eye Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Savitri', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Jhaveri Microbiology Center, Hyderabad, Telangana, India.'}, {'ForeName': 'Thirumurthy', 'Initials': 'T', 'LastName': 'Velpandian', 'Affiliation': 'Ocular Pharmacology, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Srikant K', 'Initials': 'SK', 'LastName': 'Padhy', 'Affiliation': 'Retina- Vitreous Service, Mithu Tulsi Chanrai Campus, L V Prasad Eye Institute, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Vipin A', 'Initials': 'VA', 'LastName': 'Das', 'Affiliation': 'IHOPE, Kallam Anji Reddy Campus, L V Prasad Eye Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Sisinthy', 'Initials': 'S', 'LastName': 'Shivaji', 'Affiliation': 'Jhaveri Microbiology Center, Hyderabad, Telangana, India.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Nayak', 'Affiliation': 'Retina- Vitreous Service, Kode Venkadadri Chaudhury Campus, Vijayawada, Andhra Pradesh, India.'}, {'ForeName': 'Umesh C', 'Initials': 'UC', 'LastName': 'Behera', 'Affiliation': 'Retina- Vitreous Service, Mithu Tulsi Chanrai Campus, L V Prasad Eye Institute, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Dilip K', 'Initials': 'DK', 'LastName': 'Mishra', 'Affiliation': 'Pathology Laboratory, Kallam Anji Reddy Campus, L V Prasad Eye Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Jaishree', 'Initials': 'J', 'LastName': 'Gandhi', 'Affiliation': 'Jhaveri Microbiology Center, Hyderabad, Telangana, India.'}, {'ForeName': 'Vivek P', 'Initials': 'VP', 'LastName': 'Dave', 'Affiliation': 'Srimati Kanuri Shanthamma Center for Vitreoretinal Diseases, Hyderabad, Telangana, India.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Pathengay', 'Affiliation': 'Retina-Vitreous Service, GMR Varalakshmi Campus, Vishakhapatnam, Andhra Pradesh, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_2329_21']
2639,35225460,The Effect of Omega-3 Enriched Oral Nutrition Supplement on Nutritional Indices and Quality of Life in Gastrointestinal Cancer Patients: A Randomized Clinical Trial.,"OBJECTIVE


Gastrointestinal (GI) cancer patients often experience severe malnutrition during cancer therapies due to gastrointestinal dysfunctions including poor digestion and absorption as well as tumor-associated anorexia. In this study, we performed a randomized clinical trial to determine the efficacy of oral nutrition supplement (ONS) enriched with omega-3 fatty acids on nutritional status, quality of life (QOL), and pro-inflammatory indices.
METHODS


Patients diagnosed with GI cancers were recruited and screened for eligibility. A total of 58 patients were randomly allocated to either the control group (n=27) or the experimental group (n=31). The intervention group received 200 ml ONS twice a day while the control group received routine care. Anthropometrics, Patient-Generated Subjective Global Assessment (PG-SGA) score, QOL score and nutrient intake data were collected at baseline, week 4 and week 8. Blood was drawn for biochemical assessments. Nine patients from each group dropped out of the study Forty patients (18 control patients and 22 intervention patients) completed the study.
RESULTS


This study showed that ONS intervention improved PG-SGA scores in the intervention group (p<0.01). Scores of physical functioning score and role functioning were declined only in the control group and the difference between week 8 and baseline for role functioning was significant (p<0.001). Fatigue score was steadily decreased in the experiment group, and the differences between week 8 and baseline was significant between two groups (p<0.02). However, no statistically significant improvement in biochemical markers of nutritional status and pro-inflammatory cytokine concentrations were found. These results suggests that ONS intervention for 8 weeks improves PG-SGA scores and QOL scores in patients undergoing cancer therapy.",2022,This study showed that ONS intervention improved PG-SGA scores in the intervention group (p<0.01).,"['Gastrointestinal Cancer Patients', 'Nine patients from each group dropped out of the study Forty patients (18 control patients and 22 intervention patients) completed the study', 'Gastrointestinal (GI) cancer patients', 'Patients diagnosed with GI cancers were recruited and screened for eligibility', 'patients undergoing cancer therapy', '58 patients']","['oral nutrition supplement (ONS) enriched with omega-3 fatty acids', 'ONS intervention', 'Omega-3 Enriched Oral Nutrition Supplement', '200 ml ONS twice a day while the control group received routine care']","['Anthropometrics, Patient-Generated Subjective Global Assessment (PG-SGA) score, QOL score and nutrient intake data', 'nutritional status, quality of life (QOL), and pro-inflammatory indices', 'Fatigue score', 'Scores of physical functioning score and role functioning', 'biochemical markers of nutritional status and pro-inflammatory cytokine concentrations', 'Nutritional Indices and Quality of Life', 'PG-SGA scores and QOL scores', 'PG-SGA scores']","[{'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028710', 'cui_str': 'Nutrition Index'}]",58.0,0.0824669,This study showed that ONS intervention improved PG-SGA scores in the intervention group (p<0.01).,"[{'ForeName': 'Eunbo', 'Initials': 'E', 'LastName': 'Sim', 'Affiliation': 'Department of Food and Nutrition, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Jin-Min', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': ""Department of Food and Nutrition, Sookmyung Women's University, Seoul 04310, Korea.""}, {'ForeName': 'Seung-Min', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Moon Jae', 'Initials': 'MJ', 'LastName': 'Chung', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Institute of Gastroenterology, Seoul 03722, Korea.'}, {'ForeName': 'Si Young', 'Initials': 'SY', 'LastName': 'Song', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Institute of Gastroenterology, Seoul 03722, Korea.'}, {'ForeName': 'Eun Sun', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine, Seoul 02841, South Korea.'}, {'ForeName': 'Hoon Jai', 'Initials': 'HJ', 'LastName': 'Chun', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine, Seoul 02841, South Korea.'}, {'ForeName': 'Mi-Kyung', 'Initials': 'MK', 'LastName': 'Sung', 'Affiliation': 'Department of Food and Nutrition, Yonsei University, Seoul 03722, Korea.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2022.23.2.485']
2640,35225436,Measuring the Impact of MyLupusGuide TM  in Canada: Results of a Randomized Control Study.,"OBJECTIVE


We assessed the effects of a web-based program, MyLupusGuide TM  , developed to facilitate self-management in systemic lupus erythematosus (SLE).
METHODS


A randomized control online study. Participants received either immediate access or access at 3 months to MyLupusGuide TM  . Primary outcome was the Patient Activation Measure® (PAM®). Secondary outcomes included measurements of health status, self-efficacy, coping, perceived patient-physician relationship, and adherence. Outcomes were measured at baseline, three and six months. We used linear mixed model to compare PAM® between the two groups at three and six months.
RESULTS


There were 541 participants. The average age was 50±14 years, 93% were female, 74% were White. The average disease duration was 17±12 years and 56% visited MyLupusGuide TM  at least once. The baseline average PAM® score was 61.2±13 with 36% scoring low for perceived self-management skills. After three months exposure to MyLupusGuide TM  , there were no differences in PAM® scores between groups. In exploratory analyses, we found significant improvement in PAM® scores in those who had low PAM® scores at baseline and in males. We observed significant improvements in self-efficacy pre- and post- access to MyLupusGuide TM  and delayed improvements at six versus three months in mental health and emotional coping.
CONCLUSION


MyLupusGuide TM  increased self-efficacy but not patient activation. Fifty-six percent of participants visited MyLupusGuide TM  site during the study period. Individuals with lupus need support to become activated toward self-management behaviors.",2022,"We observed significant improvements in self-efficacy pre- and post- access to MyLupusGuide TM  and delayed improvements at six versus three months in mental health and emotional coping.
","['in Canada', '541 participants', 'The average age was 50±14\u2009years, 93% were female, 74% were White']","['MyLupusGuide TM', 'immediate access or access at 3 months to MyLupusGuide TM  ', 'web-based program, MyLupusGuide TM']","['baseline average PAM® score', 'self-efficacy', 'measurements of health status, self-efficacy, coping, perceived patient-physician relationship, and adherence', 'PAM® scores', 'Patient Activation Measure® (PAM®', 'average disease duration']","[{'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2931826', 'cui_str': 'Potassium aggravated myotonia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031830', 'cui_str': 'Physician Patient Relations'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",541.0,0.0542565,"We observed significant improvements in self-efficacy pre- and post- access to MyLupusGuide TM  and delayed improvements at six versus three months in mental health and emotional coping.
","[{'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Fortin', 'Affiliation': 'Centre de recherche du CHU de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Neville', 'Affiliation': 'Centre for Outcomes Research & Evaluation, Research Institute of the McGill University Health Centre, Québec, Canada.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Julien', 'Affiliation': 'Département de mathématiques et statistique, Université Laval, Québec, Québec, Canada.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Rahme', 'Affiliation': 'Centre for Outcomes Research & Evaluation, Research Institute of the McGill University Health Centre, Québec, Canada.'}, {'ForeName': 'Vinita', 'Initials': 'V', 'LastName': 'Haroun', 'Affiliation': 'MyLupusGuide™ Patient Advisory Committee, Manitoba, Canada.'}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Nimigon-Young', 'Affiliation': 'MyLupusGuide™ Patient Advisory Committee, Manitoba, Canada.'}, {'ForeName': 'Anna-Lisa', 'Initials': 'AL', 'LastName': 'Morrison', 'Affiliation': 'MyLupusGuide™ Patient Advisory Committee, Manitoba, Canada.'}, {'ForeName': 'Davy', 'Initials': 'D', 'LastName': 'Eng', 'Affiliation': 'Centre de recherche du CHU de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Peschken', 'Affiliation': 'University of Manitoba, Manitoba, Canada.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Vinet', 'Affiliation': 'Centre for Outcomes Research & Evaluation, Research Institute of the McGill University Health Centre, Québec, Canada.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hudson', 'Affiliation': 'Jewish General Hospital, Lady Davis Institute for Medical Research and McGill University, Quebec, Canada.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'The Ottawa Hospital - University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Matsos', 'Affiliation': 'McMaster University, Ontario, Canada.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Pope', 'Affiliation': 'Department of Medicine, University of Western Ontario, Ontario, Canada.'}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Clarke', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Keeling', 'Affiliation': 'University of Alberta, Edmonton, Canada.'}, {'ForeName': 'J Antonio', 'Initials': 'JA', 'LastName': 'Avina-Zubieta', 'Affiliation': 'University of British Columbia, British Columbia, Canada.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Rochon', 'Affiliation': 'Jack Digital Productions, Inc., Montreal, Quebec and Toronto, Ontario, Canada.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Da Costa', 'Affiliation': 'Centre for Outcomes Research & Evaluation, Research Institute of the McGill University Health Centre, Québec, Canada.'}]",Arthritis care & research,['10.1002/acr.24871']
2641,35225392,Reductions in particulate matter concentrations resulting from air filtration: A randomized sham-controlled crossover study.,"One-hundred seventy-two households were recruited from regions with high outdoor air pollution (Fresno and Riverside, CA) to participate in a randomized, sham-controlled, cross-over study to determine the effectiveness of high-efficiency air filtration to reduce indoor particle exposures. In 129 households, stand-alone HEPA air cleaners were placed in a bedroom and in the main living area. In 43 households, high-efficiency MERV 16 filters were installed in central forced-air heating and cooling systems and the participating households were asked to run the system on a clean-air cycle for 15 min per hour. Participating households that completed the study received true air filtration for a year and sham air filtration for a year. Air pollution samples were collected at approximately 6-month intervals, with two measurements in each of the sham and true filtration periods. One week indoor and outdoor time-integrated samples were collected for measurement of PM 2.5  , PM 10  , and ultrafine particulate matter (UFP) measured as PM 0.2  . Reflectance measurements were also made on the PM 2.5  filters to estimate black carbon. True filtration significantly improved indoor air quality, with a 48% reduction in the geometric mean indoor PM 0.2  and PM 2.5  concentrations, and a 31% reduction in PM 10  . Geometric mean concentrations of indoor/outdoor reflectance values, indicating fraction of particles of outdoor origin remaining indoors, decreased by 77%. Improvements in particle concentrations were greater with continuously operating stand-alone air cleaners than with intermittent central system filtration. Keeping windows closed and increased utilization of the filtration systems further improved indoor air quality.",2022,"True filtration significantly improved indoor air quality, with a 48% reduction in the geometric mean indoor PM 0.2  and PM 2.5  concentrations, and a 31% reduction in PM 10  .","['One-hundred seventy-two households were recruited from regions with high outdoor air pollution (Fresno and Riverside, CA']",['ultrafine particulate matter'],"['Geometric mean concentrations of indoor/outdoor reflectance values, indicating fraction of particles of outdoor origin remaining indoors', 'indoor air quality', 'particle concentrations']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}]","[{'cui': 'C5197864', 'cui_str': 'Ultrafine Particles'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0085760', 'cui_str': 'Indoor Air Quality'}]",172.0,0.0569382,"True filtration significantly improved indoor air quality, with a 48% reduction in the geometric mean indoor PM 0.2  and PM 2.5  concentrations, and a 31% reduction in PM 10  .","[{'ForeName': 'Deborah H', 'Initials': 'DH', 'LastName': 'Bennett', 'Affiliation': 'Department of Public Health Sciences, School of Medicine, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Moran', 'Affiliation': 'Department of Public Health Sciences, School of Medicine, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Krakowiak', 'Affiliation': 'Department of Public Health Sciences, School of Medicine, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Kenyon', 'Affiliation': 'Department of Internal Medicine, School of Medicine, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Research Division, California Air Resources Board, Sacramento, California, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Fisk', 'Affiliation': 'Indoor Environment Group, Lawrence Berkeley National Laboratory, Berkeley, California, USA.'}]",Indoor air,['10.1111/ina.12982']
2642,35225388,Effect of a solar lighting intervention on fuel-based lighting use and exposure to household air pollution in rural Uganda: A randomized controlled trial.,"Solar lighting is an alternative to polluting kerosene and other fuel-based lighting devices relied upon by millions of families in resource-limited settings. Whether solar lighting provides sustained displacement of fuel-based lighting sources and reductions in personal exposure to fine particulate matter (PM 2  . 5  ) and black carbon (BC) has not been examined in randomized controlled trials. Eighty adult women living in rural Uganda who utilized fuel-based (candles and kerosene lamps) and/or clean (solar, grid, and battery-powered devices) lighting were randomized in a 1:1 ratio to receive a home solar lighting system at no cost to study participants (ClinicalTrials.gov NCT03351504). Among intervention group participants, kerosene lamps were completely displaced in 92% of households using them. The intervention led to an average exposure reduction of 36.1 μg/m 3  (95% CI -70.3 to -2.0) in PM 2  . 5  and 10.8 μg/m 3  (95% CI -17.6 to -4.1) in BC, corresponding to a reduction from baseline of 37% and 91%, respectively. Reductions were greatest among participants using kerosene lamps. Displacement of kerosene lamps and personal exposure reductions were sustained over 12 months of follow-up. Solar lighting presents an immediate opportunity for achieving sustained reductions in personal exposure to PM 2.5  and BC and should be considered in household air pollution intervention packages.",2022,The intervention led to an average exposure reduction of 36.1 μg/m 3  (95% CI -70.3 to -2.0) in PM 2  .,"['Eighty adult women living in rural Uganda who utilized fuel-based (candles and kerosene lamps) and/or clean (solar, grid, and battery-powered devices) lighting', 'rural Uganda']","['solar lighting intervention', 'black carbon (BC', 'home solar lighting system']","['kerosene lamps', 'fuel-based lighting use and exposure to household air pollution']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1850568', 'cui_str': 'Nakajo-Nishimura syndrome'}, {'cui': 'C0022611', 'cui_str': 'Kerosene'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007010', 'cui_str': 'Carbon Black'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0022611', 'cui_str': 'Kerosene'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}]",80.0,0.188919,The intervention led to an average exposure reduction of 36.1 μg/m 3  (95% CI -70.3 to -2.0) in PM 2  .,"[{'ForeName': 'Eli S', 'Initials': 'ES', 'LastName': 'Wallach', 'Affiliation': 'Schatz Energy Research Center, California State Polytechnic University, Humboldt, Arcata, California, USA.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Lam', 'Affiliation': 'Schatz Energy Research Center, California State Polytechnic University, Humboldt, Arcata, California, USA.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Nuwagira', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Muyanja', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Mellon', 'Initials': 'M', 'LastName': 'Tayebwa', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Valeri', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health, New York, New York, USA.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Tsai', 'Affiliation': 'Center for Global Health and Mongan Institute, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Vallarino', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Allen', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Peggy S', 'Initials': 'PS', 'LastName': 'Lai', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}]",Indoor air,['10.1111/ina.12986']
2643,35225329,Estimating subgroup effects in generalizability and transportability analyses.,"Methods for extending - generalizing or transporting - inferences from a randomized trial to a target population involve conditioning on a large set of covariates that is sufficient for rendering the randomized and non-randomized groups exchangeable. Yet, decision-makers are often interested in examining treatment effects in subgroups of the target population defined in terms of only a few discrete covariates. Here, we propose methods for estimating subgroup-specific potential outcome means and average treatment effects in generalizability and transportability analyses, using outcome model-based (g-formula), weighting, and augmented weighting estimators. We consider estimating subgroup-specific average treatment effects in the target population and its non-randomized subset, and provide methods that are appropriate both for nested and non-nested trial designs. As an illustration, we apply the methods to data from the Coronary Artery Surgery Study to compare the effect of surgery plus medical therapy versus medical therapy alone for chronic coronary artery disease in subgroups defined by history of myocardial infarction.",2022,"Here, we propose methods for estimating subgroup-specific potential outcome means and average treatment effects in generalizability and transportability analyses, using outcome model-based (g-formula), weighting, and augmented weighting estimators.",['chronic coronary artery disease in subgroups defined by history of myocardial infarction'],['surgery plus medical therapy versus medical therapy alone'],[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1275835', 'cui_str': 'History of myocardial infarction'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]",[],,0.081611,"Here, we propose methods for estimating subgroup-specific potential outcome means and average treatment effects in generalizability and transportability analyses, using outcome model-based (g-formula), weighting, and augmented weighting estimators.","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Robertson', 'Affiliation': 'CAUSALab, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Jon A', 'Initials': 'JA', 'LastName': 'Steingrimsson', 'Affiliation': 'Department of Biostatistics, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Nina R', 'Initials': 'NR', 'LastName': 'Joyce', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stuart', 'Affiliation': 'Departments of Mental Health, Biostatistics, and Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Issa J', 'Initials': 'IJ', 'LastName': 'Dahabreh', 'Affiliation': 'CAUSALab, Harvard T.H. Chan School of Public Health, Boston, MA.'}]",American journal of epidemiology,['10.1093/aje/kwac036']
2644,35221757,"The Efficacy and Safety of Dexmedetomidine for Sedation During Surgery Under Epidural or Spinal Anesthesia: A Randomized, Double-Blind, Placebo-Controlled Study.","Background


Only a few studies have been reported on the use of dexmedetomidine for sedating surgical patients requiring epidural or spinal anesthesia. We conducted a randomized, double-blind, placebo-controlled, parallel-group study at 12 hospitals in Japan.
Methods


Adult patients were randomly allocated to receive an intravenous administration of placebo or dexmedetomidine at 0.067, 0.25, 0.5 or 1.0 µg/kg over 10 min after epidural or spinal anesthesia. All dexmedetomidine groups received dexmedetomidine 0.2-0.7 µg/kg/h to maintain an Observer's Assessment of Alertness/Sedation Scale (OAA/S) score of ≤ 4; however, propofol was administered to rescue patients who exceeded this score. Surgery was then started 15 min after study drug infusion in patients with OAA/S score of ≤ 4. The primary endpoint was the percentage of patients not requiring rescue propofol to achieve and maintain an OAA/S score of ≤ 4.
Results


Of the 120 enrolled and randomized patients, 119 were treated the study: 22 received placebo and 97 received dexmedetomidine (23-25 patients per dose). Significantly more patients did not require propofol in the dexmedetomidine 0.5 and 1.0 µg/kg groups (68.0% and 80.0%, respectively) compared to the placebo group (22.7%) ( P  = 0.003 and  P  < 0.001, respectively). Common adverse events (AEs) were protocol-defined respiratory depression, bradycardia and hypotension. There was no significant difference in the incidence of AEs between the dexmedetomidine and the placebo groups.
Conclusion


We concluded that loading doses of 0.5 and 1.0 µg/kg dexmedetomidine, followed by an infusion at a rate of 0.2-0.7 µg/kg/h, provide effective and well-tolerated sedation for surgical patients during epidural or spinal anesthesia.
Clinical trials.gov identifier: NCT01438957.",2022,"There was no significant difference in the incidence of AEs between the dexmedetomidine and the placebo groups.
","['Methods\n\n\nAdult patients', '120 enrolled and randomized patients', 'surgical patients during epidural or spinal anesthesia', 'During Surgery Under Epidural or Spinal Anesthesia', 'sedating surgical patients requiring epidural or spinal anesthesia', '12 hospitals in Japan']","['placebo', 'Placebo', 'dexmedetomidine', 'propofol', 'placebo or dexmedetomidine', 'Dexmedetomidine']","['Efficacy and Safety', 'percentage of patients not requiring rescue propofol to achieve and maintain an OAA/S score of ≤ 4', 'incidence of AEs', 'respiratory depression, bradycardia and hypotension', 'Alertness/Sedation Scale (OAA/S) score']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",120.0,0.638206,"There was no significant difference in the incidence of AEs between the dexmedetomidine and the placebo groups.
","[{'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Inagaki', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, School of Medicine, Faculty of Medicine, Tottori University, Yonago 683-8504, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo 060-8556, Japan.'}, {'ForeName': 'Atsuhiro', 'Initials': 'A', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Anesthesiology, Nippon Medical School, Tokyo 113-8602, Japan.'}, {'ForeName': 'Akifumi', 'Initials': 'A', 'LastName': 'Okayama', 'Affiliation': 'Clinical Statistics Group 2, Biometrics & Data Management, Pfizer R&D Japan, Tokyo 151-8589, Japan.'}, {'ForeName': 'Nobuyo', 'Initials': 'N', 'LastName': 'Oya', 'Affiliation': 'Clinical Development Department, Maruishi Pharmaceutical Co., Ltd., Osaka 538-0042, Japan.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Hiraoka', 'Affiliation': 'Clinical Development Department, Maruishi Pharmaceutical Co., Ltd., Osaka 538-0042, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Morita', 'Affiliation': 'Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science, Okayama700-8558, Japan.'}]",Yonago acta medica,['10.33160/yam.2022.02.002']
2645,35221736,Development and Validation of a Prediction Model for 5-Year Risk of Kidney Dysfunction in Patients with Hypertension and Glucose Metabolism Disorder.,"Purpose


Patients with hypertension and glucose metabolism disorder (GMD) are at high risk of developing kidney dysfunction (KD). Therefore, we aimed to develop a nomogram for predicting individuals' 5-year risk of KD in hypertensives with GMD.
Patients and Methods


In total, 1961 hypertensives with GMD were consecutively included. Baseline data were extracted from medical electronic system, and follow-up data were obtained using annual health check-ups or hospital readmission. KD was defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m 2 . Subjects were randomly divided into training and validation sets with a ratio of 7 to 3. Least absolute shrinkage and selection operator method was used to identify potential predictors. Cox proportional hazard model was applied to build a nomogram for predicting KD risk. The discriminative ability, calibration and usefulness of the model were evaluated. The prediction model was verified by internal validation.
Results


During the follow-up of 5351 person-years with a median follow-up of 32 (range: 3-91) months, 130 patients developed KD. Age, sex, ethnicity, hemoglobin A1c, uric acid, and baseline eGFR were identified as significant predictors for incident KD and used for establishing nomogram. The prediction model displayed good discrimination with C-index of 0.770 (95% CI: 0.712-0.828) and 0.763 (95% CI: 0.704-0.823) in training and validation sets, respectively. Calibration curve indicated good agreement between the predicted and actual probabilities. The decision curve analysis demonstrated that the model was clinically useful.
Conclusion


The prediction nomogram, including six common easy-to-obtain factors, shows good performance for predicting 5-year risk of KD in hypertensives with GMD. This quantitative tool could help clinicians, and even primary care providers, recognize potential KD patients early and make strategy for prevention and management.",2022,"The prediction model displayed good discrimination with C-index of 0.770 (95% CI: 0.712-0.828) and 0.763 (95% CI: 0.704-0.823) in training and validation sets, respectively.","['5351 person-years with a median follow-up of 32 (range: 3-91) months, 130 patients developed KD', 'Patients with hypertension and glucose metabolism disorder (GMD', 'Patients with Hypertension and Glucose Metabolism Disorder', 'hypertensives with GMD', '1961 hypertensives with GMD were consecutively included']",[],"['glomerular filtration rate (eGFR', 'Age, sex, ethnicity, hemoglobin A1c, uric acid, and baseline eGFR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151746', 'cui_str': 'Abnormal renal function'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1257958', 'cui_str': 'Disorder of glucose metabolism'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",1961.0,0.017235,"The prediction model displayed good discrimination with C-index of 0.770 (95% CI: 0.712-0.828) and 0.763 (95% CI: 0.704-0.823) in training and validation sets, respectively.","[{'ForeName': 'Mengyue', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Hypertension Center of People\'s Hospital of Xinjiang Uygur Autonomous Region; Xinjiang Hypertension Institute; National Health Committee Key Laboratory of Hypertension Clinical Research; Key Laboratory of Xinjiang Uygur Autonomous Region ""Hypertension Research Laboratory""; Xinjiang Clinical Medical Research Center for Hypertension (Cardio-Cerebrovascular) Diseases, Urumqi, People\'s Republic of China.'}, {'ForeName': 'Mulalibieke', 'Initials': 'M', 'LastName': 'Heizhati', 'Affiliation': 'Hypertension Center of People\'s Hospital of Xinjiang Uygur Autonomous Region; Xinjiang Hypertension Institute; National Health Committee Key Laboratory of Hypertension Clinical Research; Key Laboratory of Xinjiang Uygur Autonomous Region ""Hypertension Research Laboratory""; Xinjiang Clinical Medical Research Center for Hypertension (Cardio-Cerebrovascular) Diseases, Urumqi, People\'s Republic of China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Gan', 'Affiliation': 'Hypertension Center of People\'s Hospital of Xinjiang Uygur Autonomous Region; Xinjiang Hypertension Institute; National Health Committee Key Laboratory of Hypertension Clinical Research; Key Laboratory of Xinjiang Uygur Autonomous Region ""Hypertension Research Laboratory""; Xinjiang Clinical Medical Research Center for Hypertension (Cardio-Cerebrovascular) Diseases, Urumqi, People\'s Republic of China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Hypertension Center of People\'s Hospital of Xinjiang Uygur Autonomous Region; Xinjiang Hypertension Institute; National Health Committee Key Laboratory of Hypertension Clinical Research; Key Laboratory of Xinjiang Uygur Autonomous Region ""Hypertension Research Laboratory""; Xinjiang Clinical Medical Research Center for Hypertension (Cardio-Cerebrovascular) Diseases, Urumqi, People\'s Republic of China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Hypertension Center of People\'s Hospital of Xinjiang Uygur Autonomous Region; Xinjiang Hypertension Institute; National Health Committee Key Laboratory of Hypertension Clinical Research; Key Laboratory of Xinjiang Uygur Autonomous Region ""Hypertension Research Laboratory""; Xinjiang Clinical Medical Research Center for Hypertension (Cardio-Cerebrovascular) Diseases, Urumqi, People\'s Republic of China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Hypertension Center of People\'s Hospital of Xinjiang Uygur Autonomous Region; Xinjiang Hypertension Institute; National Health Committee Key Laboratory of Hypertension Clinical Research; Key Laboratory of Xinjiang Uygur Autonomous Region ""Hypertension Research Laboratory""; Xinjiang Clinical Medical Research Center for Hypertension (Cardio-Cerebrovascular) Diseases, Urumqi, People\'s Republic of China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': 'Hypertension Center of People\'s Hospital of Xinjiang Uygur Autonomous Region; Xinjiang Hypertension Institute; National Health Committee Key Laboratory of Hypertension Clinical Research; Key Laboratory of Xinjiang Uygur Autonomous Region ""Hypertension Research Laboratory""; Xinjiang Clinical Medical Research Center for Hypertension (Cardio-Cerebrovascular) Diseases, Urumqi, People\'s Republic of China.'}, {'ForeName': 'Zihao', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Hypertension Center of People\'s Hospital of Xinjiang Uygur Autonomous Region; Xinjiang Hypertension Institute; National Health Committee Key Laboratory of Hypertension Clinical Research; Key Laboratory of Xinjiang Uygur Autonomous Region ""Hypertension Research Laboratory""; Xinjiang Clinical Medical Research Center for Hypertension (Cardio-Cerebrovascular) Diseases, Urumqi, People\'s Republic of China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Hypertension Center of People\'s Hospital of Xinjiang Uygur Autonomous Region; Xinjiang Hypertension Institute; National Health Committee Key Laboratory of Hypertension Clinical Research; Key Laboratory of Xinjiang Uygur Autonomous Region ""Hypertension Research Laboratory""; Xinjiang Clinical Medical Research Center for Hypertension (Cardio-Cerebrovascular) Diseases, Urumqi, People\'s Republic of China.'}, {'ForeName': 'Nanfang', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Hypertension Center of People\'s Hospital of Xinjiang Uygur Autonomous Region; Xinjiang Hypertension Institute; National Health Committee Key Laboratory of Hypertension Clinical Research; Key Laboratory of Xinjiang Uygur Autonomous Region ""Hypertension Research Laboratory""; Xinjiang Clinical Medical Research Center for Hypertension (Cardio-Cerebrovascular) Diseases, Urumqi, People\'s Republic of China.'}]",Risk management and healthcare policy,['10.2147/RMHP.S345059']
2646,35221706,"A Potential Role of Ethosuximide and Pentoxifylline in Relieving Abdominal Pain in Irritable Bowel Syndrome Patients Treated with Mebeverine: A Randomized, Double-Blind, Placebo-Controlled Trial.","Background and Purpose


Irritable bowel syndrome (IBS) is defined as an association of chronic abdominal pain with bowel habit abnormalities, without clear organic dysfunction. T-type calcium channels and low-grade mucosal inflammation are linked to abdominal pain; however, medical treatments for IBS abdominal pain are largely ineffective. In this study, we investigated if pentoxifylline (PTX) and ethosuximide could potentially alleviate abdominal pain in patients with IBS treated with mebeverine.
Methods


We recruited 150 patients from Tanta University Hospital to this randomized, prospective, and double blinded study. Patients were randomly allocated to three groups (n = 50). Group 1 (mebeverine) received 135 mg mebeverine three times/day (t.i.d). Group 2 (ethosuximide group) received 135 mg mebeverine t.i.d plus 250 mg ethosuximide twice daily (b.i.d) and group 3 (PTX group) received 135 mg mebeverine t.i.d plus 400 mg PTX b.i.d. Patients were assessed by a gastroenterologist at baseline and 6 months after therapy. Serum interleukin-8 (IL-8), IL-6, tumor necrosis-α (TNF-α), fecal myeloperoxidase, and fecal neutrophil gelatinase associated lipocalin (NGAL) levels were measured before and after therapy. The numeric pain rating scale (NRS) was also assessed before and after therapy.
Primary Outcomes


Reduced NRS scores and abdominal pain relief.
Secondary Outcomes


Decreased inflammatory biomarkers.
Results


After 6 months, groups 2 and 3 showed a significantly greater reduction in serum IL-8, IL-6, TNF-α, fecal myeloperoxidase, and fecal NGAL levels when compared to group 1 after therapy. Both groups 2 and 3 showed significant reductions in NRS scores when compared to the group 1.
Conclusion


Ethosuximide and PTX may be promising, novel adjunct drugs to antispasmodics for relieving abdominal pain in patients with IBS.
Trial Registration


Identifier: NCT04217733.",2022,"After 6 months, groups 2 and 3 showed a significantly greater reduction in serum IL-8, IL-6, TNF-α, fecal myeloperoxidase, and fecal NGAL levels when compared to group 1 after therapy.","['patients with IBS', 'Irritable Bowel Syndrome Patients Treated with Mebeverine', '150 patients from Tanta University Hospital', 'patients with IBS treated with mebeverine']","['Placebo', 'mebeverine t.i.d plus 250 mg ethosuximide twice daily (b.i.d) and group 3 (PTX group) received 135 mg mebeverine t.i.d plus 400 mg PTX b.i.d', 'pentoxifylline (PTX) and ethosuximide', 'Ethosuximide and PTX', 'Ethosuximide and Pentoxifylline']","['NRS scores and abdominal pain relief', 'inflammatory biomarkers', 'NRS scores', 'abdominal pain', 'numeric pain rating scale (NRS', 'serum IL-8, IL-6, TNF-α, fecal myeloperoxidase, and fecal NGAL levels', 'Serum interleukin-8 (IL-8), IL-6, tumor necrosis-α (TNF-α), fecal myeloperoxidase, and fecal neutrophil gelatinase associated lipocalin (NGAL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0065832', 'cui_str': 'mebeverine'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065832', 'cui_str': 'mebeverine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0015043', 'cui_str': 'Ethosuximide'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0333516', 'cui_str': 'Tumor necrosis'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}]",150.0,0.378448,"After 6 months, groups 2 and 3 showed a significantly greater reduction in serum IL-8, IL-6, TNF-α, fecal myeloperoxidase, and fecal NGAL levels when compared to group 1 after therapy.","[{'ForeName': 'Sahar M', 'Initials': 'SM', 'LastName': 'El-Haggar', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, El-Gharbia Government, Tanta, 31527, Egypt.'}, {'ForeName': 'Sahar K', 'Initials': 'SK', 'LastName': 'Hegazy', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, El-Gharbia Government, Tanta, 31527, Egypt.'}, {'ForeName': 'Sherief M', 'Initials': 'SM', 'LastName': 'Abd-Elsalam', 'Affiliation': 'Tropical Medicine and Infectious Diseases Department, Faculty of Medicine, Tanta University, Tanta, 315274, Egypt.'}, {'ForeName': 'Eslam B', 'Initials': 'EB', 'LastName': 'Elkaeed', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, AlMaarefa University, Riyadh, 13713, Saudi Arabia.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Al-Karmalawy', 'Affiliation': 'Department of Pharmaceutical Medicinal Chemistry, Faculty of Pharmacy, Horus University-Egypt, New Damietta, 34518, Egypt.'}, {'ForeName': 'Mostafa M', 'Initials': 'MM', 'LastName': 'Bahaa', 'Affiliation': 'Pharmacy Practice Department, Faculty of Pharmacy, Horus University, New Damietta, Egypt.'}]",Journal of inflammation research,['10.2147/JIR.S346608']
2647,35221683,"Integrated Disease Management for Chronic Obstructive Pulmonary Disease in Primary Care, from the Controlled Trial to Clinical Program: A Cohort Study.","Purpose


Integrated disease management (IDM) for COPD in primary care has been primarily investigated under clinical trial conditions. We previously published a randomized controlled trial (RCT) where the IDM intervention improved quality of life (QoL) and exacerbation-related outcomes. In this study, we assess the same IDM intervention in a real-world evaluation and identify patient characteristics associated with improved outcomes.
Methods


This historical cohort study included patients enrolled for 12 (±3 months) in the Best Care COPD IDM program. The main outcome was a ≥3 point improvement in COPD assessment test (CAT). Secondary outcomes were COPD exacerbations requiring antibiotics and/or prednisone, unscheduled physician visits, emergency department visits and hospitalizations.
Results


Data for 571 patients ( all patients)  were included, 158 met the reference RCT eligibility  (RCT matched) . Improved QoL was observed in 43% (95% CI:38.9,47.2) of  all patients , 47% (95% CI:39.5,55.6) of  RCT matched  vs 92% (95% CI:79.2,95.1) in the reference RCT intervention arm (n=72). Reductions (12 months IDM vs prior year) were observed in the proportion of patients experiencing exacerbation-related events ( all patients ): antibiotics/prednisone (-9.0%,95% CI:-13.9,-3.9); unscheduled physician (-33.1%,95% CI:-38.2,-27.9); emergency department (-9.6%,95% CI:-13.5,-5); and hospitalizations (-6.8%,95% CI:-10.0,-3.7). For the  RCT matched group  all reductions were comparable to the reference RCT intervention arm. The strongest predictors of improved QoL were baseline CAT, CAT≥20 vs CAT<10 (OR 15.6,95% CI:7.91,30.83), GOLD group B (OR 6.4,95% CI:3.42,11.85) and D (OR 5.64,95% CI:2.80,11.37) vs GOLD group A. Patients with prior antibiotic/prednisone use, FEV 1  <30% predicted and GOLD group D were less likely to have no urgent health service utilization (OR 0.5,95% CI:0.30,0.68), (OR 0.2,95% CI:0.07,0.78) and (OR 0.3,95% CI:0.14,0.51), respectively.
Conclusion


Best Care COPD improved QoL and reduced exacerbation-related outcomes in a manner directionally similar to the RCT from which it emanated. Baseline QoL, exacerbation history, and GOLD category were identified as possible predictors of IDM impact and will inform future program development and resource allocation.",2021,"Improved QoL was observed in 43% (95% CI:38.9,47.2) of  all patients , 47% (95% CI:39.5,55.6) of  RCT matched  vs 92% (95% CI:79.2,95.1) in the reference RCT intervention arm (n=72).","['571 patients ( all patients)  were included, 158 met the reference', 'patients enrolled for 12 (±3 months) in the Best Care COPD IDM program']",['IDM intervention'],"['urgent health service utilization', 'unscheduled physician', 'Improved QoL', 'quality of life (QoL) and exacerbation-related outcomes', 'Baseline QoL, exacerbation history, and GOLD category', 'COPD assessment test (CAT', 'COPD exacerbations requiring antibiotics and/or prednisone, unscheduled physician visits, emergency department visits and hospitalizations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",571.0,0.297086,"Improved QoL was observed in 43% (95% CI:38.9,47.2) of  all patients , 47% (95% CI:39.5,55.6) of  RCT matched  vs 92% (95% CI:79.2,95.1) in the reference RCT intervention arm (n=72).","[{'ForeName': 'Anna J', 'Initials': 'AJ', 'LastName': 'Hussey', 'Affiliation': 'Asthma Research Group Windsor-Essex County Inc., Windsor, ON, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Wing', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Madonna', 'Initials': 'M', 'LastName': 'Ferrone', 'Affiliation': 'Asthma Research Group Windsor-Essex County Inc., Windsor, ON, Canada.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Licskai', 'Affiliation': 'Asthma Research Group Windsor-Essex County Inc., Windsor, ON, Canada.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S338851']
2648,35221681,Economic Evaluation of a Reablement Training Program for Homecare Staff Targeting Sedentary Behavior in Community-Dwelling Older Adults Compared to Usual Care: A Cluster Randomized Controlled Trial.,"Purpose


Training and supporting homecare staff in reablement aims to change staff behavior from ""doing for"" to ""doing with"" older adults and is assumed to benefit the health and quality of life of older adults and reduce healthcare utilization and costs. This study evaluated the cost-effectiveness and cost-utility of the staff reablement training program ""Stay Active at Home"" (SAaH) from a societal perspective.
Participants and Methods


An economic evaluation was embedded in a 12-month cluster randomized controlled trial. Ten Dutch homecare nursing teams participated (n = 313 staff members), of which five teams were trained in reablement and the other five provided usual care. Cost and effect data were collected from 264 older adults at baseline, 6 and 12 months. Costs included ""intervention,"" ""healthcare,"" and ""patient and family"" costs (collectively, societal costs) and were assessed using questionnaires and client records or estimated by bottom-up micro-costing. Effects included sedentary behavior and quality-adjusted life years (QALYs). Multiple imputed bootstrapped data were used to generate cost-effectiveness planes and acceptability curves.
Results


No statistically significant differences were observed between the intervention and control group in terms of sedentary time (adjusted mean difference: 4.8 minutes [95% CI -26.4, 36.0]), QALYs ( 0.01 [95% CI -0.03, 0.04]), and societal costs ( €2216 [95% CI -459, 4895]), except lower costs for domestic help in the intervention group ( €-173 [95% CI -299, -50]). The probability that SAaH was cost-effective compared to usual care ranged from 7.1% to 19.9%, depending on the willingness-to-pay (WTP) (€0‒€50,000)/minute of sedentary time averted and was 5.9% at a WTP of €20,000/QALY gained.
Conclusion


SAaH did not improve outcomes or reduce costs and was not cost-effective from a societal perspective compared to usual care in Dutch older adults receiving homecare. Consequently, there is insufficient evidence to justify widespread implementation of the training program in its current form.
Trial Registration


ClinicalTrials.gov: NCT03293303.",2021,"Conclusion


SAaH did not improve outcomes or reduce costs and was not cost-effective from a societal perspective compared to usual care in Dutch older adults receiving homecare.","['Homecare Staff', ' older adults', 'Dutch older adults receiving homecare', 'Community-Dwelling Older Adults', 'Ten Dutch homecare nursing teams participated (n = 313 staff members', '264 older adults at baseline, 6 and 12 months']","['Reablement Training Program', 'Usual Care', 'staff reablement training program ""Stay Active at Home"" (SAaH']","['Costs included ""intervention,"" ""healthcare,"" and ""patient and family"" costs (collectively, societal costs', 'cost-effectiveness and cost-utility', 'sedentary time', 'societal costs', 'sedentary behavior and quality-adjusted life years (QALYs']","[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0028704', 'cui_str': 'Team Nursing'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",10.0,0.0218133,"Conclusion


SAaH did not improve outcomes or reduce costs and was not cost-effective from a societal perspective compared to usual care in Dutch older adults receiving homecare.","[{'ForeName': 'Teuni H', 'Initials': 'TH', 'LastName': 'Rooijackers', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Silke F', 'Initials': 'SF', 'LastName': 'Metzelthin', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Rossum', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Gertrudis I J M', 'Initials': 'GIJM', 'LastName': 'Kempen', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Silvia M A A', 'Initials': 'SMAA', 'LastName': 'Evers', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gabrio', 'Affiliation': 'Department of Methodology and Statistics, Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'G A Rixt', 'Initials': 'GAR', 'LastName': 'Zijlstra', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}]",Clinical interventions in aging,['10.2147/CIA.S341221']
2649,35221680,An Individual Cognitive Stimulation Therapy App for People with Dementia and Carers: Results from a Feasibility Randomized Controlled Trial (RCT).,"Background


There is a lack of digital resources that support the cognition and quality of life (QoL) of people with dementia. The individual cognitive stimulation therapy application (iCST app) aims to provide cognitive stimulation and social interaction to people with dementia and carers through interactive touch-screen technology. This study set out to determine the feasibility of conducting a full-scale, randomized controlled trial (RCT) with the iCST app.
Methods


This was a single blind, feasibility RCT including people with mild to moderate dementia and their carers. Multiple trial components were assessed including recruitment and retention rates, intervention fidelity and usability, and acceptability of the outcome assessments which included measures of cognition and QoL. A sample of the intervention group was invited to a semi-structured post-trial interview to examine the experience of using the iCST app.
Results


Sixty-one dyads were randomised to the iCST app (n = 31) or treatment-as-usual (TAU) control group (n = 30) for 11 weeks. In the iCST app group, 77% used the intervention for 20 minutes or more each week. Carers using the iCST app rated their QoL better at follow-up 2 compared to the TAU control group (EQ-5D, MD = 7.69, 95% CI = 2.32-13.06, p = 0.006). No significant differences were found on the other outcome measures.
Conclusion


The iCST app was deemed usable and enjoyable. Most participants completed the activities more quickly than anticipated and did not have enough activities to continue using the app frequently. Expansion of the iCST app is needed to maintain engagement for longer. Findings indicate that computerised cognitive stimulation can be beneficial, and a large-scale RCT is feasible with modifications to trial components. The results are relevant to researchers, software developers, policy-makers, people with dementia and carers who are looking to be involved in such interventions.
Trial Registration


ClinicalTrials.gov, NCT03282877. Registered on 19 July 2017.",2021,"Carers using the iCST app rated their QoL better at follow-up 2 compared to the TAU control group (EQ-5D, MD = 7.69, 95% CI = 2.32-13.06, p = 0.006).","['people with mild to moderate dementia and their carers', 'People with Dementia and Carers', 'Results\n\n\nSixty-one dyads', 'people with dementia and carers through interactive touch-screen technology']","['iCST', 'Individual Cognitive Stimulation Therapy App', 'individual cognitive stimulation therapy application (iCST app']","['recruitment and retention rates, intervention fidelity and usability, and acceptability of the outcome assessments which included measures of cognition and QoL. A sample', 'cognition and quality of life (QoL']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0085565', 'cui_str': 'Outcome Assessment (Health Care)'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",61.0,0.133497,"Carers using the iCST app rated their QoL better at follow-up 2 compared to the TAU control group (EQ-5D, MD = 7.69, 95% CI = 2.32-13.06, p = 0.006).","[{'ForeName': 'Harleen Kaur', 'Initials': 'HK', 'LastName': 'Rai', 'Affiliation': 'Department of Computer & Information Sciences, University of Strathclyde, Livingstone Tower, Glasgow, Scotland, G1 1HX, UK.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'School of Sociology & Social Policy, Law & Social Sciences Building, University of Nottingham, University Park, Nottingham, England, NG7 2RD, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orrell', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Jubilee Campus, Nottingham, England, NG7 2TU, UK.'}]",Clinical interventions in aging,['10.2147/CIA.S323994']
2650,35221673,"Pharmacokinetic Drug Interaction Between Amlodipine and Tadalafil: An Open-Label, Randomized, Multiple-Dose Crossover Study in Healthy Male Volunteers.","Purpose


The combined administration of tadalafil, a phosphodiesterase-5 inhibitor, and amlodipine, a calcium channel blocker, can be a promising therapeutic option for hypertension patients with erectile dysfunction. This study aimed to examine the pharmacokinetic drug interaction between tadalafil and amlodipine and the tolerability of their combined administration in healthy male subjects.
Subjects and Methods


Healthy volunteers (N = 24) were randomly assigned to one of the six sequences that consisted of three treatments: tadalafil (5 mg) alone, amlodipine (10 mg) alone, and tadalafil plus amlodipine. The study drugs were administered orally for 9 d, and the collected serial blood samples were analyzed up to 72 h after the last dosing. Pharmacokinetic parameters were calculated using non-compartmental analysis.
Results


For tadalafil, geometric mean ratios (GMRs) (90% confidence interval (CI)) of the combined therapy over the monotherapy were 1.57 (1.46-1.68) for AUC τ,ss  and 1.34 (1.24-1.45) for C max,ss . For amlodipine, the GMRs (90% CI) of AUC τ,ss  and C max,ss  were 0.93 (0.90-0.97) and 0.95 (0.91-0.99), respectively. The severity of all observed adverse events (AEs) related to the study drugs was mild, and the frequency of AEs of the combined administration was not significantly different from the monotherapy.
Conclusion


A substantial pharmacokinetic drug interaction between tadalafil and amlodipine was observed with respect to the concentration of tadalafil when administered concomitantly. However, the dose range of the combined administration of tadalafil and amlodipine in the present study was well tolerated by the subjects.",2022,"For amlodipine, the GMRs (90% CI) of AUC τ,ss  and C max,ss  were 0.93 (0.90-0.97) and 0.95 (0.91-0.99), respectively.","['Healthy Male Volunteers', 'healthy male subjects', 'hypertension patients with erectile dysfunction', 'Subjects and Methods\n\n\nHealthy volunteers (N = 24']","['Amlodipine and Tadalafil', 'tadalafil, a phosphodiesterase-5 inhibitor, and amlodipine, a calcium channel blocker', 'amlodipine', 'tadalafil and amlodipine', 'tadalafil', 'tadalafil (5 mg) alone, amlodipine (10 mg) alone, and tadalafil plus amlodipine']","['Pharmacokinetic parameters', 'frequency of AEs of the combined administration', 'geometric mean ratios (GMRs']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C1318700', 'cui_str': 'Phosphodiesterase 5 inhibitor'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",24.0,0.0351182,"For amlodipine, the GMRs (90% CI) of AUC τ,ss  and C max,ss  were 0.93 (0.90-0.97) and 0.95 (0.91-0.99), respectively.","[{'ForeName': 'Hyungsub', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medical Services, College of Health Sciences, Eulji University, Seongnam, Republic of Korea.'}, {'ForeName': 'Shi Hyang', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan, Seoul, Republic of Korea.'}, {'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': 'Hanmi Pharmaceutical Co. Ltd., Seoul, Republic of Korea.'}, {'ForeName': 'Sunghee', 'Initials': 'S', 'LastName': 'Hong', 'Affiliation': 'Hanmi Pharmaceutical Co. Ltd., Seoul, Republic of Korea.'}, {'ForeName': 'Hyeong-Seok', 'Initials': 'HS', 'LastName': 'Lim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan, Seoul, Republic of Korea.'}]","Drug design, development and therapy",['10.2147/DDDT.S348897']
2651,35222106,Treatment of Pregnant Women With Fear of Childbirth Using EMDR Therapy: Results of a Multi-Center Randomized Controlled Trial.,"Fear of childbirth (FoC) occurs in 7. 5% of pregnant women and has been associated with adverse feto-maternal outcomes. Eye Movement Desensitization and Reprocessing (EMDR) therapy has proven to be effective in the treatment of posttraumatic stress disorder (PTSD) and anxiety; however, its effectiveness regarding FoC has not yet been established. The aim was to determine the safety and effectiveness of EMDR therapy for pregnant women with FoC. This single-blind RCT (the OptiMUM-study, www.trialregister.nl, NTR5122) was conducted in the Netherlands. FoC was defined as a score ≥85 on the Wijma Delivery Expectations Questionnaire (WDEQ-A). Pregnant women with FoC and a gestational age between 8 and 20 weeks were randomly assigned to EMDR therapy or care-as-usual (CAU). The severity of FoC was assessed using the WDEQ-A. Safety was indexed as worsening of FoC symptoms, dropout, serious adverse events, or increased suicide risk. We used linear mixed model analyses to compare groups. A total of 141 women were randomized (EMDR  n  = 70; CAU  n  = 71). No differences between groups were found regarding safety. Both groups showed a very large (EMDR  d  = 1.36) or large (CAU  d  = 0.89) reduction of FoC symptoms with a mean decrease of 25.6 (EMDR) and 17.4 (CAU) points in WDEQ-A sum score. No significant difference between both groups was found ( p  = 0.83). At posttreatment, 72.4% (EMDR) vs. 59.6% (CAU) no longer met the criteria for FoC. In conclusion, the results are supportive of EMDR therapy as a safe and effective treatment of FoC during pregnancy, albeit without significant beneficial effects of EMDR therapy over and above those of CAU. Therefore, the current study results do not justify implementation of EMDR therapy as an additional treatment in this particular setting.",2021,"At posttreatment, 72.4% (EMDR) vs. 59.6% (CAU) no longer met the criteria for FoC.","['Pregnant women with FoC and a gestational age between 8 and 20 weeks', 'Pregnant Women With Fear of Childbirth Using EMDR Therapy', 'pregnant women with FoC', 'A total of 141 women were randomized (EMDR  n  = 70; CAU  n  = 71']","['EMDR therapy or care-as-usual (CAU', 'Eye Movement Desensitization and Reprocessing (EMDR) therapy', 'EMDR therapy']","['safety and effectiveness', 'worsening of FoC symptoms, dropout, serious adverse events, or increased suicide risk', 'FoC symptoms', 'Fear of childbirth (FoC', 'Wijma Delivery Expectations Questionnaire (WDEQ-A', 'severity of FoC']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0522187', 'cui_str': 'Tocophobia'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0178702', 'cui_str': 'Desensitization therapy'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0522187', 'cui_str': 'Tocophobia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",141.0,0.0333533,"At posttreatment, 72.4% (EMDR) vs. 59.6% (CAU) no longer met the criteria for FoC.","[{'ForeName': 'M A M', 'Initials': 'MAM', 'LastName': 'Baas', 'Affiliation': 'Department of Obstetrics and Gynecology, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'van Pampus', 'Affiliation': 'Department of Obstetrics and Gynecology, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'C A I', 'Initials': 'CAI', 'LastName': 'Stramrood', 'Affiliation': 'Department of Obstetrics and Gynecology, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Dijksman', 'Affiliation': 'Department of Quality and Safety, St. Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Vanhommerig', 'Affiliation': 'Department of Research and Epidemiology, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Jongh', 'Affiliation': 'Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam, Vrije Universiteit University Amsterdam, Amsterdam, Netherlands.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2021.798249']
2652,35222092,Effects of Integrative Neuromuscular Training Combined With Regular Tennis Training Program on Sprint and Change of Direction of Children.,"Objective


The aim of this study was to investigate the effects of integrative neuromuscular training (NMT) on sprint and the ability to change direction for children who are between the ages of 7 and 8 and beginning to play tennis.
Methods


Thirty-two participants were randomized into a training group (TG;  n  = 16) and a control group (CG;  n  = 16). All participants attended tennis classes twice a week for a continuous 8 weeks. In addition, the TG received NMT (e.g., 20-m sprints, running at four corners, rope ladder drills, etc.), which progressed in difficulty every 2 weeks. Pre-intervention and post-intervention measurements, including a 30-m sprint test, a 5-10-5 test, and a 3 × 10 m shuttle run test, were assessed by a Smartspeed laser timing gate system, while the spider agility test was evaluated with a stopwatch.
Results


Two-way repeated measures ANOVA found significant differences in the interaction between time and group among variables measured. Results were as follows: time in the 30 m sprint ( F  = 13.467, 95% CI = 7.163-7.506,  p  = 0.001,  η   2   p   = 0.310, Δ = 0.42 s); 5-10-5 test ( F  = 13.975, 95% CI = 8.696-9.017,  p  = 0.001,  η   2   p   = 0.318, Δ = 0.78 s); 3 × 10 m shuttle run ( F  = 7.605, 95% CI = 11.213-11.642,  p  = 0.01,  η   2   p   = 0.202, Δ = 0.77 s); and spider agility test ( F  = 34.555, 95% CI = 28.258-29.670,  p  < 0.001,  η   2   p   = 0.535, Δ = 3.96 s). The results demonstrated a greater decrease in sprint and change of direction (COD) time among the TG than the CG from pre-intervention to post-intervention.
Conclusion


A regular tennis training combined with NMT program could produce greater improvement in a player's sprint and ability to change direction when introduced to childhood tennis beginners in a sensitive period, compared to tennis class intervention only.",2022,"The results demonstrated a greater decrease in sprint and change of direction (COD) time among the TG than the CG from pre-intervention to post-intervention.
","['children who are between the ages of 7 and 8 and beginning to play tennis', 'Children', 'Methods\n\n\nThirty-two participants']","['regular tennis training combined with NMT program', 'integrative neuromuscular training (NMT', 'Integrative Neuromuscular Training Combined With Regular Tennis Training Program']","[""player's sprint and ability to change direction"", 'sprint and change of direction (COD) time', 'spider agility test']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",32.0,0.0439924,"The results demonstrated a greater decrease in sprint and change of direction (COD) time among the TG than the CG from pre-intervention to post-intervention.
","[{'ForeName': 'Zhi-Hai', 'Initials': 'ZH', 'LastName': 'Wang', 'Affiliation': 'School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Rui-Cheng', 'Initials': 'RC', 'LastName': 'Pan', 'Affiliation': 'School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Meng-Ru', 'Initials': 'MR', 'LastName': 'Huang', 'Affiliation': 'School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'School of Physical Education and Sport Training, Shanghai University of Sport, Shanghai, China.'}]",Frontiers in physiology,['10.3389/fphys.2022.831248']
2653,35222091,"Assessment of Ultra-Early Administration of Sacubitril Valsartan to Improve Cardiac Remodeling in Patients With Acute Myocardial Infarction Following Primary PCI: Rational and Design of a Prospective, Multicenter, Randomized Controlled Trial.","Background


Despite coronary re-vascularization, the common complications of acute myocardial infarction (AMI), cardiac remodeling, and heart failure (HF), is increasing globally. Sacubitril valsartan (SV), an angiotensin receptor-neprilysin inhibitor (ARNI), has been previously demonstrated to improve HF. We further hypothesize that ultra-early SV treatment is also effective in preventing cardiac remodeling for patients with AMI following primary percutaneous coronary intervention (PCI).
Methods


The Assessment of ultra-early administration of Sacubitril Valsartan to improve cardiac remodeling in patients with Acute Myocardial Infarction following primary PCI (ASV-AMI) trial is a prospective, multicenter, randomized controlled trial in China planning to enroll at least 1,942 eligible patients from 10 centers. After successful primary PCI of culprit artery within 24 h, AMI patients are randomized to 2 h group or 3-7 days group with SV treatment. The major endpoints are echocardiographic measurement, cardiothoracic ratio, and N-Terminal pro-B-Type Natriuretic Peptide (NT pro-BNP) at baseline, 1, 3, 6, and 12 months. The secondary endpoints included MACE (cardiac arrest, cardiogenic death, myocardial infarction, and target vessel re-vascularization), in-/out-patient HF, EuroQol Five Dimensions Questionnaire (EQ-5D), and Kansas City Cardiomyopathy Questionnaire (KCCQ).
Discussion


The ASV-AMI trial is the first clinical trial of ultra-early administration of SV in the treatment of post-PCI AMI, adding more clinical evidence. Early application of SV to prevent cardiac remodeling in AMI patient is a major focus of this trial.
Clinical Trial Registration


Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn; ChiCTR2100051979). Registered on 11 October 2021.",2022,"The secondary endpoints included MACE (cardiac arrest, cardiogenic death, myocardial infarction, and target vessel re-vascularization), in-/out-patient HF, EuroQol Five Dimensions Questionnaire (EQ-5D), and Kansas City Cardiomyopathy Questionnaire (KCCQ).
","['patients with Acute Myocardial Infarction following primary PCI (ASV-AMI', '1,942 eligible patients from 10 centers', 'Patients With Acute Myocardial Infarction', 'patients with AMI following primary percutaneous coronary intervention (PCI']","['ultra-early SV treatment', 'Sacubitril valsartan (SV), an angiotensin receptor-neprilysin inhibitor (ARNI', 'Primary PCI', 'Sacubitril Valsartan']","['MACE (cardiac arrest, cardiogenic death, myocardial infarction, and target vessel re-vascularization), in-/out-patient HF, EuroQol Five Dimensions Questionnaire (EQ-5D), and Kansas City Cardiomyopathy Questionnaire (KCCQ', 'Cardiac Remodeling', 'echocardiographic measurement, cardiothoracic ratio, and N-Terminal pro-B-Type Natriuretic Peptide (NT pro-BNP', 'cardiac remodeling']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0004429', 'cui_str': 'Avian sarcoma virus'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C2733251', 'cui_str': 'EuroQoL five dimension questionnaire'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C2363738', 'cui_str': 'Cardiothoracic ratio'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]",,0.219366,"The secondary endpoints included MACE (cardiac arrest, cardiogenic death, myocardial infarction, and target vessel re-vascularization), in-/out-patient HF, EuroQol Five Dimensions Questionnaire (EQ-5D), and Kansas City Cardiomyopathy Questionnaire (KCCQ).
","[{'ForeName': 'Zhengwei', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}]",Frontiers in physiology,['10.3389/fphys.2022.831212']
2654,35222072,High-Intensity Inspiratory Muscle Training Improves Scalene and Sternocleidomastoid Muscle Oxygenation Parameters in Patients With Weaning Difficulties: A Randomized Controlled Trial.,"Background


Critically ill patients who have difficulties weaning from the mechanical ventilator are prone to develop respiratory muscle weakness. Inspiratory muscle training (IMT) can improve respiratory muscle strength. Whether IMT can improve scalene and sternocleidomastoid muscle oxygenation parameters is unknown.
Aim


To compare changes in muscle oxygenation parameters of scalene and sternocleidomastoid inspiratory muscles during a standardized task between patients with weaning difficulties who received either high-intensity IMT (intervention) or sham low-intensity IMT (control).
Method


Forty-one patients performed daily IMT sessions (4 sets, 6-10 breaths) until weaning success or for 28 consecutive days. The training load was progressively adjusted in the intervention group ( n  = 22) to the highest tolerable load, whilst the control group ( n  = 19) kept training at 10% of their baseline maximal inspiratory pressure (PImax). Breathing characteristics (i.e., work and power of breathing, PoB), respiratory muscle function [i.e., PImax and forced vital capacity (FVC)] were measured during a standardized loaded breathing task against a load of 30% of baseline PImax before and after the IMT period. In addition, during the same loaded breathing task, absolute mean and nadir changes from baseline in local scalene and sternocleidomastoid muscle oxygen saturation index (Δ%StiO 2 ) (an index of oxygen extraction) and nadir Δ%StiO 2  normalized for the PoB were measured by near-infrared spectroscopy.
Results


At post measures, only the intervention group improved mean PoB compared to pre measures (Pre: 0.42 ± 0.33 watts, Post: 0.63 ± 0.51watts,  p -value < 0.01). At post measures, both groups significantly improved nadir scalene muscles StiO 2 % normalized for the mean PoB (ΔStiO  nadir  %/watt) compared to pre measurements and the improvement was not significant different between groups ( p -value = 0.40). However, at post measures, nadir sternocleidomastoid muscle StiO 2 % normalized for the mean PoB (ΔStiO  nadir  %/watt) was significantly greater improved in the intervention group (mean difference: +18.4, 95%CI: -1.4; 38.1) compared to the control group (mean difference: +3.7, 95%CI: -18.7; 26.0, between group  p -value < 0.01). Both groups significantly improved PImax (Intervention: +15 ± 13 cmH 2 O  p -value < 0.01, Control: +13 ± 15 cmH 2 O  p -value < 0.01). FVC only significantly improved in the intervention group (+0.33 ± 0.31 L  p  < 0.01) report also change in control group.
Conclusion


This exploratory study suggests that high-intensity IMT induces greater improvements in scalene and sternocleidomastoid muscle oxygenation parameters attributed for oxygen delivery, utilization and oxygen saturation index compared to low-intensity IMT in patients with weaning difficulties.",2022,"Both groups significantly improved PImax (Intervention: +15 ± 13 cmH 2 O  p -value < 0.01, Control: +13 ± 15 cmH 2 O  p -value < 0.01).","['patients with weaning difficulties', 'Patients With Weaning Difficulties', 'patients with weaning difficulties who received either']","['95%CI', 'IMT', 'high-intensity IMT (intervention) or sham low-intensity IMT (control', 'Inspiratory muscle training (IMT', 'High-Intensity Inspiratory Muscle Training', 'control group ( n  = 19) kept training at 10% of their baseline maximal inspiratory pressure (PImax', 'IMT sessions']","['utilization and oxygen saturation index', 'FVC', 'nadir scalene muscles StiO', 'local scalene and sternocleidomastoid muscle oxygen saturation index (Δ%StiO 2 ) (an index of oxygen extraction) and nadir Δ%StiO 2  normalized for the PoB', 'mean PoB', 'nadir sternocleidomastoid muscle StiO', 'Breathing characteristics (i.e., work and power of breathing, PoB), respiratory muscle function [i.e., PImax and forced vital capacity (FVC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0075208', 'cui_str': 'stearyl-isomaltosyl oligosaccharide'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0031441', 'cui_str': 'Phenoxybenzamine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",41.0,0.0431272,"Both groups significantly improved PImax (Intervention: +15 ± 13 cmH 2 O  p -value < 0.01, Control: +13 ± 15 cmH 2 O  p -value < 0.01).","[{'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Van Hollebeke', 'Affiliation': 'Faculty of Movement and Rehabilitation Sciences, Department of Rehabilitation Sciences, Research Group for Rehabilitation in Internal Disorders, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Poddighe', 'Affiliation': 'Faculty of Movement and Rehabilitation Sciences, Department of Rehabilitation Sciences, Research Group for Rehabilitation in Internal Disorders, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Clerckx', 'Affiliation': 'Department of Intensive Care Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Muller', 'Affiliation': 'Department of Intensive Care Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Hermans', 'Affiliation': 'Department of Intensive Care Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Gosselink', 'Affiliation': 'Faculty of Movement and Rehabilitation Sciences, Department of Rehabilitation Sciences, Research Group for Rehabilitation in Internal Disorders, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Langer', 'Affiliation': 'Faculty of Movement and Rehabilitation Sciences, Department of Rehabilitation Sciences, Research Group for Rehabilitation in Internal Disorders, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Zafeiris', 'Initials': 'Z', 'LastName': 'Louvaris', 'Affiliation': 'Faculty of Movement and Rehabilitation Sciences, Department of Rehabilitation Sciences, Research Group for Rehabilitation in Internal Disorders, KU Leuven, Leuven, Belgium.'}]",Frontiers in physiology,['10.3389/fphys.2022.786575']
2655,35222277,A Surgeon-Centered Neuromuscular Block Protocol Improving Intraoperative Neuromonitoring Outcome of Thyroid Surgery.,"Background


Neuromuscular blocking agents provide muscular relaxation for tracheal intubation and surgery. However, the degree of neuromuscular block may disturb neuromuscular transmission and lead to weak electromyography during intraoperative neuromonitoring. This study aimed to investigate a surgeon-friendly neuromuscular block degree titrated sugammadex protocol to maintain both intraoperative neuromonitoring quality and surgical relaxation during thyroid surgery.
Methods


A total of 116 patients were enrolled into two groups and underwent elective thyroid surgery with intraoperative neuromonitoring. All patients followed a standardized intraoperative neuromonitoring protocol with continuous neuromuscular transmission monitoring and received 0.6 mg/kg rocuronium for tracheal intubation. Patients were allocated into two groups according to the degree of neuromuscular block when the anterior surface of the thyroid gland was exposed. The neuromuscular block degree was assessed by the train-of-four (TOF) count and ratio. Patients in group I received sugammadex 0.25 mg/kg for non-deep neuromuscular block degree (TOF count = 1~4). Patients in group II were administered sugammadex 0.5 mg/kg for deep neuromuscular block degree (TOF count = 0). The quality of the intraoperative neuromonitoring was measured using the V 1  electromyography (EMG) amplitude. An amplitude less than 500 μV and greater than 500 μV was defined as weak and satisfactory, respectively.
Results


The quality of the intraoperative neuromonitoring was not different between groups I and II (satisfactory/weak: 75/1 vs. 38/2,  P  = 0.14). The quality of surgical relaxation was acceptable after sugammadex injection and showed no difference between groups [55/76 (72.3%) in group I vs. 33/40 (82.5%) in group II,  P  = 0.23].
Conclusions


This surgeon-centered sugammadex protocol guided by neuromuscular block degree (0.5 mg/kg for deep block and 0.25 mg/kg for others) showed comparably high intraoperative neuromonitoring quality and adequate surgical relaxation. The results expanded the practicality of sugammadex for precise neuromuscular block management during monitored thyroidectomy.",2022,"The quality of surgical relaxation was acceptable after sugammadex injection and showed no difference between groups [55/76 (72.3%) in group I vs. 33/40 (82.5%) in group II,  P  = 0.23].
","['116 patients were enrolled into two groups and underwent', 'Thyroid Surgery']","['sugammadex', 'standardized intraoperative neuromonitoring protocol with continuous neuromuscular transmission monitoring and received 0.6 mg/kg rocuronium', 'sugammadex 0.25 mg/kg for non-deep neuromuscular block degree', 'elective thyroid surgery with intraoperative neuromonitoring']","['intraoperative neuromonitoring quality and adequate surgical relaxation', 'quality of surgical relaxation', 'quality of the intraoperative neuromonitoring', 'neuromuscular block degree']","[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0193769', 'cui_str': 'Operation on thyroid gland'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0193769', 'cui_str': 'Operation on thyroid gland'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",116.0,0.11697,"The quality of surgical relaxation was acceptable after sugammadex injection and showed no difference between groups [55/76 (72.3%) in group I vs. 33/40 (82.5%) in group II,  P  = 0.23].
","[{'ForeName': 'I-Cheng', 'Initials': 'IC', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, Kaohsiung Municipal Siaogang Hospital, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Chiung-Dan', 'Initials': 'CD', 'LastName': 'Hsu', 'Affiliation': 'Department of Anesthesiology, Kaohsiung Municipal Siaogang Hospital, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Pi-Ying', 'Initials': 'PY', 'LastName': 'Chang', 'Affiliation': 'Department of Anesthesiology, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Sheng-Hua', 'Initials': 'SH', 'LastName': 'Wu', 'Affiliation': 'Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Tzu-Yen', 'Initials': 'TY', 'LastName': 'Huang', 'Affiliation': 'Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Yi-Chu', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Department of Otorhinolaryngology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'How-Yun', 'Initials': 'HY', 'LastName': 'Ko', 'Affiliation': 'Department of Otorhinolaryngology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Gianlorenzo', 'Initials': 'G', 'LastName': 'Dionigi', 'Affiliation': 'Division of General Surgery, Endocrine Surgery Section, Istituto Auxologico Italiano IRCCS (Istituto di ricovero e cura a carattere scientifico), Milan, Italy.'}, {'ForeName': 'Young Jun', 'Initials': 'YJ', 'LastName': 'Chai', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Transdisciplinary Department of Medicine & Advanced Technology, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Feng-Yu', 'Initials': 'FY', 'LastName': 'Chiang', 'Affiliation': 'Department of Otolaryngology, E-Da Hospital, I-Shou University, Kaohsiung, Taiwan.'}, {'ForeName': 'Yi-Wei', 'Initials': 'YW', 'LastName': 'Kuo', 'Affiliation': 'Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Che-Wei', 'Initials': 'CW', 'LastName': 'Wu', 'Affiliation': 'Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}]",Frontiers in endocrinology,['10.3389/fendo.2022.817476']
2656,35222756,"Ablation of typical atrial flutter using mini electrode measurements for maximum voltage-guided ablation: A randomized, controlled trial.","Background


Novel ablation catheters with mini electrode (ME) sensing have become available but their utility is unclear. We investigated whether ablation of the cavotricuspid isthmus (CTI) for atrial flutter (AFL) would be improved using ME signals.
Methods


Sixty-one patients (76% male, 63 ± 10 years) with CTI-dependent AFL underwent ablation using a maximum voltage-guided approach, randomized to either standard 8 mm non-irrigated catheter with bipolar signals or IntellaTip MiFi catheter using ME signals alone.
Results


Acute bidirectional block was achieved in 97%. Mean follow-up was 16.7 ± 10 months. The median number of ablation lesions was 13 in both groups (range 3-62 vs. 1-43,  p  = .85). No significant differences were observed in AFL recurrences (17% vs. 11%,  p  = .7), median procedure durations (97 min [interquartile range (IQR), 71-121] vs. 87 min [IQR, 72-107],  p  = .55) or fluoroscopy times (31 min [IQR, 21-52] vs. 38 min [IQR, 25-70],  p  = .56). Amplitudes of ME signals were on average 160% greater than blinded bipolar signals. In 23.7% of lesions where bipolar signals were difficult to interpret, 13.6% showed a clear ME signal.
Conclusions


There was no difference in the effectiveness of CTI ablation guided by ME signals, compared with using bipolar signals from a standard 8 mm ablation catheter. While ME signal amplitudes were larger and sometimes present when the bipolar signal was unclear, this did not improve procedural characteristics or outcomes. The results suggest future research should focus on lesion integrity rather than signal sensing.",2022,"No significant differences were observed in AFL recurrences (17% vs. 11%,  p  = .7), median procedure durations (97 min [interquartile range (IQR), 71-121] vs. 87 min [IQR, 72-107],  p  = .55) or fluoroscopy times (31 min [IQR, 21-52] vs. 38 min [IQR, 25-70],  ","['Methods\n\n\nSixty-one patients (76% male, 63\xa0±\xa010\xa0years) with CTI-dependent AFL underwent ablation using a']","['typical atrial flutter using mini electrode measurements', 'maximum voltage-guided ablation', 'maximum voltage-guided approach, randomized to either standard 8\xa0mm non-irrigated catheter with bipolar signals or IntellaTip MiFi catheter using ME signals alone', 'cavotricuspid isthmus (CTI', '\n\n\nNovel ablation catheters with mini electrode (ME']","['Acute bidirectional block', 'AFL recurrences', 'fluoroscopy times', 'Amplitudes of ME signals', 'median number of ablation lesions', 'median procedure durations']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0229583', 'cui_str': 'Structure of isthmus of thyroid gland'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C3264370', 'cui_str': 'Typical atrial flutter'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0229583', 'cui_str': 'Structure of isthmus of thyroid gland'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0656156,"No significant differences were observed in AFL recurrences (17% vs. 11%,  p  = .7), median procedure durations (97 min [interquartile range (IQR), 71-121] vs. 87 min [IQR, 72-107],  p  = .55) or fluoroscopy times (31 min [IQR, 21-52] vs. 38 min [IQR, 25-70],  ","[{'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Rowe', 'Affiliation': 'Department of Cardiology Princess Alexandra Hospital Brisbane Queensland Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Claughton', 'Affiliation': 'Department of Cardiology Princess Alexandra Hospital Brisbane Queensland Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Department of Cardiology Princess Alexandra Hospital Brisbane Queensland Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Yee', 'Affiliation': 'Department of Cardiology Princess Alexandra Hospital Brisbane Queensland Australia.'}, {'ForeName': 'Gerald C', 'Initials': 'GC', 'LastName': 'Kaye', 'Affiliation': 'Department of Cardiology Princess Alexandra Hospital Brisbane Queensland Australia.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Dauber', 'Affiliation': 'Department of Cardiology Princess Alexandra Hospital Brisbane Queensland Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Department of Cardiology Princess Alexandra Hospital Brisbane Queensland Australia.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gould', 'Affiliation': 'Department of Cardiology Princess Alexandra Hospital Brisbane Queensland Australia.'}]",Journal of arrhythmia,['10.1002/joa3.12665']
2657,35222745,Economic evaluation of an early childhood development center-based agriculture and nutrition intervention in Malawi.,"Malnutrition is a leading cause of death and disability among children in low-income countries. Nutrition-sensitive interventions show promise in increasing food access and improving diets. There are possible synergies of integrating these programs with other sectors, improving effectiveness by leveraging resources. However, economic evaluations of these multi-sectoral programs are limited. We aimed to estimate the cost efficiency, cost-effectiveness, benefit-cost ratio, and net benefit of using community-based early childhood development (ECD) centers as platforms for an intervention promoting agricultural production and nutrition among households with young children in Malawi. The intervention was costed using bottom-up micro-costing and top-down expenditure analysis with a societal perspective and a 12-month horizon. Effectiveness estimates were derived from a cluster-randomized control trial. Premature deaths and stunting cases averted were estimated using the Lived Saved Tool. We calculated DALYs averted, and the value of three benefits streams resulting from reductions in premature mortality, increases in lifetime productivity and household agricultural productivity. We transferred the US value of a statistical life (VSL) to Malawi using an income elasticity of 1.5, and a 10% discount rate. Probabilistic sensitivity analysis was conducted using a Monte Carlo model. The intervention cost $197,377, reaching 4,806 beneficiaries at $41 per beneficiary, $595 per case of stunting, $18,310 per death, and $516 per DALY averted. Net benefit estimates ranged from $507,589 to $4,678,258, and benefit-cost ratios from 3.57 to 24.70. Sensitivity analyses confirmed a positive return on investment. Implementing agriculture-nutrition interventions through ECD platforms may be an efficient use of resources in Malawi and similar contexts.",2022,Sensitivity analyses confirmed a positive return on investment.,"['early childhood development center-based agriculture and nutrition intervention in Malawi', 'households with young children in Malawi', 'children in low-income countries']",[],"['cost efficiency, cost-effectiveness, benefit-cost ratio', 'lifetime productivity and household agricultural productivity']","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001829', 'cui_str': 'Farming'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0454664', 'cui_str': 'Country'}]",[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010187', 'cui_str': 'Benefits and Costs'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0020052', 'cui_str': 'Households'}]",,0.0467196,Sensitivity analyses confirmed a positive return on investment.,"[{'ForeName': 'Gelli', 'Initials': 'G', 'LastName': 'A', 'Affiliation': 'International Food Policy Research Institute, Washington, D.C. USA.'}, {'ForeName': 'Kemp', 'Initials': 'K', 'LastName': 'Cg', 'Affiliation': 'Department of Global Health, University of Washington, Washington, USA.'}, {'ForeName': 'Margolies', 'Initials': 'M', 'LastName': 'A', 'Affiliation': 'Consultant, International Food Policy Research Institute, Washington, D.C. USA.'}, {'ForeName': 'Twalibu', 'Initials': 'T', 'LastName': 'A', 'Affiliation': 'Consultant, International Food Policy Research Institute, Washington, D.C. USA.'}, {'ForeName': 'Katundu', 'Initials': 'K', 'LastName': 'M', 'Affiliation': 'Chancellor College, University of Malawi, Zomba, Malawi.'}, {'ForeName': 'Levin', 'Initials': 'L', 'LastName': 'C', 'Affiliation': 'Department of Global Health, University of Washington, Washington, USA.'}]",Food security,['10.1007/s12571-021-01203-6']
2658,35222719,Effects of alprostadil combined with hyperbaric oxygen on hearing recovery and hemorheology in patients with sudden sensorineural hearing loss and analysis of related influencing factors.,"The causes of sudden sensorineural hearing loss (SSNHL) are unclear, and the condition cannot be treated with specific regimens. The present study was designed to explore the effects of alprostadil combined with hyperbaric oxygen (HBO) on hearing recovery and hemorheology in patients with SSNHL, and to analyze factors influencing treatment efficacy. in total, 104 patients with SSNHL were enrolled between January 2015 and July 2018 in a randomized controlled trial. Group A (n=52) received alprostadil treatment and Group B (n=52) were treated with HBO plus alprostadil. Following treatment, the overall recovery rates of tinnitus, aural fullness and vertigo in Group B were significantly higher than those in Group A (P<0.05). Low-, middle- and high-shear whole blood viscosity and whole blood viscosity in the two groups significantly decreased, and those in Group B were significantly lower than those in Group A (P<0.05). The present results indicated that the combination of alprostadil with HBO can improve the therapeutic effect on SSNHL, reduce blood viscosity and improve coagulation function, thus significantly promoting hearing recovery. Further, SSNHL treatment efficacy was influenced by age, time of onset, hearing threshold, presence or absence of tinnitus, plasma viscosity and serum C-reactive protein levels. The trial registration number for the present study was: NCT02563872.",2022,"Following treatment, the overall recovery rates of tinnitus, aural fullness and vertigo in Group B were significantly higher than those in Group A (P<0.05).","['patients with SSNHL', 'patients with sudden sensorineural hearing loss and analysis of related influencing factors', '104 patients with SSNHL were enrolled between January 2015 and July 2018']","['alprostadil combined with hyperbaric oxygen (HBO', 'alprostadil combined with hyperbaric oxygen', 'HBO plus alprostadil', 'alprostadil treatment']","['overall recovery rates of tinnitus, aural fullness and vertigo', 'blood viscosity and whole blood viscosity', 'blood viscosity and improve coagulation function', 'time of onset, hearing threshold, presence or absence of tinnitus, plasma viscosity and serum C-reactive protein levels', 'hearing recovery and hemorheology']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C0002335', 'cui_str': 'Alprostadil'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0005848', 'cui_str': 'Blood viscosity'}, {'cui': 'C0427691', 'cui_str': 'Whole blood viscosity measurement'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0234732', 'cui_str': 'Threshold of hearing'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0427685', 'cui_str': 'Plasma viscosity measurement'}, {'cui': 'C1277266', 'cui_str': 'Serum C reactive protein level'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0206502', 'cui_str': 'Hemorrheology'}]",104.0,0.0263047,"Following treatment, the overall recovery rates of tinnitus, aural fullness and vertigo in Group B were significantly higher than those in Group A (P<0.05).","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'Department of Otolaryngology, Zibo Central Hospital, Zibo, Shandong 255036, P.R. China.'}, {'ForeName': 'Qinqin', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Otolaryngology, Zibo Central Hospital, Zibo, Shandong 255036, P.R. China.'}, {'ForeName': 'Jiasha', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Otolaryngology, Zibo Central Hospital, Zibo, Shandong 255036, P.R. China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology, Zibo Central Hospital, Zibo, Shandong 255036, P.R. China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': 'Department of Otolaryngology, Zibo Central Hospital, Zibo, Shandong 255036, P.R. China.'}]",Experimental and therapeutic medicine,['10.3892/etm.2022.11167']
2659,35225821,Parent SMART (Substance Misuse in Adolescents in Residential Treatment): Protocol of a Randomized Effectiveness Trial of a Technology-Assisted Parenting Intervention.,"BACKGROUND


Adolescents in residential substance use treatment are at extremely high risk for relapse following discharge to the community. Parenting practices, including parental monitoring and parent-adolescent communication, have been established as key predictors of adolescent substance use outcomes and relapse. However, traditional office-based therapy may not be feasible for parents who face structural and systemic barriers. There is a clear need for effective, accessible, and scalable interventions for parents of adolescents receiving residential substance use treatment. In a prior pilot randomized controlled trial, we tested Parent SMART (Substance Misuse among Adolescents in Residential Treatment)-a technology-assisted parenting intervention informed by extensive formative research-as an adjunct to residential treatment as usual (TAU). Parent SMART demonstrated high feasibility and acceptability, as well as evidence of effectiveness in improving parental monitoring and communication.
OBJECTIVE


This protocol paper describes a fully-powered randomized controlled pragmatic effectiveness trial of Parent SMART as an adjunct to residential TAU. We hypothesize that families who receive Parent SMART will demonstrate greater improvements in parenting skills, reductions in adolescent substance use, and reductions in adolescent problem behaviors relative to families that receive residential TAU. We will test the exploratory hypothesis that reductions in adolescent substance use will be partially mediated by improvements in parenting skills.
METHODS


Adolescent-parent dyads (n = 220 dyads; 440 total) will be randomized to either residential TAU only or Parent SMART+TAU. Parents randomized to Parent SMART will receive access to a networking forum, an off-the-shelf computer program called Parenting Wisely, and up to four telehealth coaching calls. Multimethod follow-up assessments consisting of self-reported parent and adolescent measures, a parent-adolescent in vivo interaction task, and 8-panel urine screens will be conducted 6, 12, and 24 weeks postdischarge from residential care. Measures will assess parenting skills, adolescent substance use, and adolescent problem behaviors. Analyses will be conducted using latent change score structural equation modeling.
RESULTS


The trial was funded in August 2021; ethics approval was obtained in August 2020, prior to funding. Due to concerns with the administrative interface in the pilot trial, the Parent SMART networking forum is currently being rebuilt by a different vendor. The programming is scheduled to be completed by December 2021, with recruitment beginning in February 2022.
CONCLUSIONS


The proposed research has the potential to advance the field by serving a high-need, underserved population during a vital treatment juncture; targeting parenting practices (putative mediators) that have been shown to predict adolescent substance use outcomes; addressing barriers to accessing continuing care; and testing a highly scalable intervention model.
TRIAL REGISTRATION


ClinicalTrials.gov NCT05169385; https://clinicaltrials.gov/ct2/show/NCT05169385.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/35934.",2022,"Parenting practices, including parental monitoring and parent-adolescent communication, have been established as key predictors of adolescent substance use outcomes and relapse.","['among Adolescents in Residential Treatment)-a technology-assisted parenting intervention', 'in Adolescents in Residential Treatment', 'parents of adolescents receiving residential substance use treatment', 'Adolescent-parent dyads (n = 220 dyads; 440 total']","['Parent SMART', 'residential TAU only or Parent', 'Technology-Assisted Parenting Intervention', 'Parent SMART (Substance Misuse']","['parenting skills, adolescent substance use, and adolescent problem behaviors', 'parenting skills']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0035189', 'cui_str': 'Residential Treatment'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0150359', 'cui_str': 'Substance use therapy'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0035189', 'cui_str': 'Residential Treatment'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439861', 'cui_str': 'Substance'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",,0.165308,"Parenting practices, including parental monitoring and parent-adolescent communication, have been established as key predictors of adolescent substance use outcomes and relapse.","[{'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Becker', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Helseth', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States.'}, {'ForeName': 'Lourah M', 'Initials': 'LM', 'LastName': 'Kelly', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Janssen', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Wolff', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, United States.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wright', 'Affiliation': 'Rosecrance Health Network, University of Illinois College of Medicine, Rockford, IL, United States.'}]",JMIR research protocols,['10.2196/35934']
2660,35225819,A Smartphone-Based Model of Care to Support Patients With Cardiac Disease Transitioning From Hospital to the Community (TeleClinical Care): Pilot Randomized Controlled Trial.,"BACKGROUND


Patients hospitalized with acute coronary syndrome (ACS) or heart failure (HF) are frequently readmitted. This is the first randomized controlled trial of a mobile health intervention that combines telemonitoring and education for inpatients with ACS or HF to prevent readmission.
OBJECTIVE


This study aims to investigate the feasibility, efficacy, and cost-effectiveness of a smartphone app-based model of care (TeleClinical Care [TCC]) in patients discharged after ACS or HF admission.
METHODS


In this pilot, 2-center randomized controlled trial, TCC was applied at discharge along with usual care to intervention arm participants. Control arm participants received usual care alone. Inclusion criteria were current admission with ACS or HF, ownership of a compatible smartphone, age ≥18 years, and provision of informed consent. The primary end point was the incidence of unplanned 30-day readmissions. Secondary end points included all-cause readmissions, cardiac readmissions, cardiac rehabilitation completion, medication adherence, cost-effectiveness, and user satisfaction. Intervention arm participants received the app and Bluetooth-enabled devices for measuring weight, blood pressure, and physical activity daily plus usual care. The devices automatically transmitted recordings to the patients' smartphones and a central server. Thresholds for blood pressure, heart rate, and weight were determined by the treating cardiologists. Readings outside these thresholds were flagged to a monitoring team, who discussed salient abnormalities with the patients' usual care providers (cardiologists, general practitioners, or HF outreach nurses), who were responsible for further management. The app also provided educational push notifications. Participants were followed up after 6 months.
RESULTS


Overall, 164 inpatients were randomized (TCC: 81/164, 49.4%; control: 83/164, 50.6%; mean age 61.5, SD 12.3 years; 130/164, 79.3% men; 128/164, 78% admitted with ACS). There were 11 unplanned 30-day readmissions in both groups (P=.97). Over a mean follow-up of 193 days, the intervention was associated with a significant reduction in unplanned hospital readmissions (21 in TCC vs 41 in the control arm; P=.02), including cardiac readmissions (11 in TCC vs 25 in the control arm; P=.03), and higher rates of cardiac rehabilitation completion (20/51, 39% vs 9/49, 18%; P=.03) and medication adherence (57/76, 75% vs 37/74, 50%; P=.002). The average usability rating for the app was 4.5/5. The intervention cost Aus $6028 (US $4342.26) per cardiac readmission saved. When modeled in a mainstream clinical setting, enrollment of 237 patients was projected to have the same expenditure compared with usual care, and enrollment of 500 patients was projected to save approximately Aus $100,000 (approximately US $70,000) annually.
CONCLUSIONS


TCC was feasible and safe for inpatients with either ACS or HF. The incidence of 30-day readmissions was similar; however, long-term benefits were demonstrated, including fewer readmissions over 6 months, improved medication adherence, and improved cardiac rehabilitation completion.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12618001547235; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375945.",2022,"Over a mean follow-up of 193 days, the intervention was associated with a significant reduction in unplanned hospital readmissions (21 in TCC vs 41 in the control arm; P=.02), including cardiac readmissions (11 in TCC vs 25 in the control arm; P=.03), and higher rates of cardiac rehabilitation completion (20/51, 39% vs 9/49, 18%; P=.03) and medication adherence (57/76, 75% vs 37/74, 50%; P=.002).","['patients discharged after ACS or HF admission', '164 inpatients', 'inpatients with ACS or HF to prevent readmission', 'inpatients with either ACS or HF', 'With Cardiac Disease Transitioning From Hospital to the Community', '237 patients was projected to have the same expenditure compared with usual care, and enrollment of 500 patients was projected to save approximately Aus $100,000 (approximately US $70,000) annually', 'Patients hospitalized with acute coronary syndrome (ACS) or heart failure (HF', 'Inclusion criteria were current admission with ACS or HF, ownership of a compatible smartphone, age ≥18 years, and provision of informed consent', 'mean age 61.5, SD 12.3 years; 130/164, 79.3% men; 128/164, 78% admitted with ACS', ""patients' usual care providers (cardiologists, general practitioners, or HF outreach nurses), who were responsible for further management"", 'TeleClinical Care']","['smartphone app-based model of care (TeleClinical Care [TCC', 'mobile health intervention', 'app and Bluetooth-enabled devices for measuring weight, blood pressure, and physical activity daily plus usual care', 'usual care alone', 'TCC']","['medication adherence, and improved cardiac rehabilitation completion', 'cardiac readmission saved', 'unplanned 30-day readmissions', 'incidence of unplanned 30-day readmissions', 'unplanned hospital readmissions', 'rates of cardiac rehabilitation completion', 'blood pressure, heart rate, and weight', 'average usability rating', 'incidence of 30-day readmissions', 'medication adherence', 'cause readmissions, cardiac readmissions, cardiac rehabilitation completion, medication adherence, cost-effectiveness, and user satisfaction', 'feasibility, efficacy, and cost-effectiveness', 'cardiac readmissions']","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0029981', 'cui_str': 'Ownership'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0586969', 'cui_str': 'Outreach nurse'}, {'cui': 'C1273518', 'cui_str': 'Responsible to'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0077072', 'cui_str': 'triclocarban'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",164.0,0.204291,"Over a mean follow-up of 193 days, the intervention was associated with a significant reduction in unplanned hospital readmissions (21 in TCC vs 41 in the control arm; P=.02), including cardiac readmissions (11 in TCC vs 25 in the control arm; P=.03), and higher rates of cardiac rehabilitation completion (20/51, 39% vs 9/49, 18%; P=.03) and medication adherence (57/76, 75% vs 37/74, 50%; P=.002).","[{'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Indraratna', 'Affiliation': 'Department of Cardiology, Prince of Wales Hospital, Randwick, Australia.'}, {'ForeName': 'Uzzal', 'Initials': 'U', 'LastName': 'Biswas', 'Affiliation': 'Graduate School of Biomedical Engineering, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McVeigh', 'Affiliation': 'Department of Cardiology, Prince of Wales Hospital, Randwick, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mamo', 'Affiliation': 'Department of Cardiology, Prince of Wales Hospital, Randwick, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Magdy', 'Affiliation': 'Department of Cardiology, Prince of Wales Hospital, Randwick, Australia.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Vickers', 'Affiliation': 'Department of Cardiology, Prince of Wales Hospital, Randwick, Australia.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Watkins', 'Affiliation': 'Department of Cardiology, Prince of Wales Hospital, Randwick, Australia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ziegl', 'Affiliation': 'Center for Health and Bioresources, Austrian Institute of Technology, Graz, Austria.'}, {'ForeName': 'Hueiming', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Cholerton', 'Affiliation': 'Department of Cardiology, Prince of Wales Hospital, Randwick, Australia.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Prince of Wales Hospital, Randwick, Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Holgate', 'Affiliation': 'Department of Cardiology, Prince of Wales Hospital, Randwick, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fildes', 'Affiliation': 'Department of Cardiology, Prince of Wales Hospital, Randwick, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Gallagher', 'Affiliation': 'Susan Wakil School of Nursing and Midwifery, Charles Perkins Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Cate', 'Initials': 'C', 'LastName': 'Ferry', 'Affiliation': 'National Heart Foundation of Australia, Sydney, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Briggs', 'Affiliation': 'Stats Central, Mark Wainwright Analytical Centre, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Guenter', 'Initials': 'G', 'LastName': 'Schreier', 'Affiliation': 'Center for Health and Bioresources, Austrian Institute of Technology, Graz, Austria.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Redmond', 'Affiliation': 'Graduate School of Biomedical Engineering, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Loh', 'Affiliation': 'Department of Cardiology, The Sutherland Hospital, Sydney, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, Prince of Wales Hospital, Randwick, Australia.'}, {'ForeName': 'Nigel H', 'Initials': 'NH', 'LastName': 'Lovell', 'Affiliation': 'Graduate School of Biomedical Engineering, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Sze-Yuan', 'Initials': 'SY', 'LastName': 'Ooi', 'Affiliation': 'Department of Cardiology, Prince of Wales Hospital, Randwick, Australia.'}]",JMIR mHealth and uHealth,['10.2196/32554']
2661,35225793,Magnesium-based resorbable scaffold vs permanent metallic sirolimus-eluting stent in patients with ST-segment elevation myocardial infarction: 3-year results of the MAGSTEMI randomised controlled trial.,"BACKGROUND


Long-term safety and performance of magnesium-based bioresorbable scaffolds (MgBRS) in ST-segment-elevation myocardial infarction (STEMI) patients are uncertain.
AIMS


To report the 3-year clinical outcomes of the MAGSTEMI trial.
METHODS


This investigator-driven, multicentre, randomised, single-blind, controlled trial randomised STEMI patients 1:1 to MgBRS or to permanent metallic sirolimus-eluting stents (SES) at 11 academic centres. The main secondary endpoints included device-oriented composite endpoints (DoCE) and patient-oriented composite endpoints (PoCE), their individual components, any bleeding, and device thrombosis rate. All endpoints were defined according to the Academic Research Consortium. Events were adjudicated by an independent committee.
RESULTS


Three-year clinical follow-up was obtained in 142 (90.0%) patients. At 3-year follow-up, MgBRS were associated with a higher rate of DoCE than SES (13 [17.6%] vs 5 [6.6%], diff -11.0 [95% CI: -21.3 to -0.7]; p=0.038). This difference was driven by an increased incidence of DoCE within the first year of follow-up. In the landmark analysis, there was no difference between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). The difference in the rate of DoCE was driven by a higher incidence of target lesion revascularisation (TLR) in the MgBRS group compared to SES (12 [16.2%] vs 4 [5.3%]; diff -10.9% [95% CI: -20.7 to -1.2]; p=0.030). The difference in TLR was observed during the first year, with no further differences observed between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000).
CONCLUSIONS


At 3-year follow-up, MgBRS were associated with a higher rate of TLR, which was clustered within the first year, compared to SES.",2022,"At 3-year follow-up, MgBRS were associated with a higher rate of TLR, which was clustered within the first year, compared to SES.","['at 11 academic centres', 'patients with ST-segment elevation myocardial infarction']","['permanent metallic sirolimus-eluting stents (SES', 'Magnesium-based resorbable scaffold vs permanent metallic sirolimus-eluting stent', 'magnesium-based bioresorbable scaffolds (MgBRS']","['rate of DoCE', 'device-oriented composite endpoints (DoCE) and patient-oriented composite endpoints (PoCE), their individual components, any bleeding, and device thrombosis rate', 'TLR', 'incidence of DoCE', 'target lesion revascularisation (TLR', 'rate of TLR']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",,0.389232,"At 3-year follow-up, MgBRS were associated with a higher rate of TLR, which was clustered within the first year, compared to SES.","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ortega-Paz', 'Affiliation': ""Interventional Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ""Interventional Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Gomez-Lara', 'Affiliation': 'Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alfonso', 'Affiliation': 'Hospital Universitario de La Princesa, Madrid, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Cequier', 'Affiliation': 'Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Romaní', 'Affiliation': 'Hospital San Pedro de Alcántara, Cáceres, Spain.'}, {'ForeName': 'Pascual', 'Initials': 'P', 'LastName': 'Bordes', 'Affiliation': 'Hospital General de Alicante, Alicante, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Serra', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Iñiguez', 'Affiliation': 'Hospital Alvaro Cunqueiro, Vigo, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Salinas', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'García Del Blanco', 'Affiliation': ""Hospital Vall d'Hebrón, Barcelona, Spain.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Goicolea', 'Affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Hernández-Antolín', 'Affiliation': 'Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cuesta', 'Affiliation': 'Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain.'}, {'ForeName': 'Joan Antoni', 'Initials': 'JA', 'LastName': 'Gómez-Hospital', 'Affiliation': 'Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': ""Interventional Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-21-00651']
2662,35226221,Cardiac computed tomographic angiography after abnormal ischemia test as a gatekeeper to invasive coronary angiography.,"This study aimed to determine the impact of systematic coronary computed tomographic angiography (CCTA) use following an abnormal non-invasive ischemia test (NIST) on patient selection strategy for invasive coronary angiography (ICA). In patients with suspected stable coronary artery disease (CAD), NIST use frequently results in sub-optimal diagnostic and revascularization yields of ICA. This randomized clinical trial, conducted at a single academic tertiary center, selected 220 symptomatic patients with mild-to-moderately abnormal NIST results who were referred for ICA. Patients received either the originally intended ICA (n = 105) or CCTA (n = 115). The primary endpoint was the diagnostic yield of ICA in each group. Revascularization yield and major adverse cardiovascular events at 12 months were also assessed. The patients were 69 ± 9 years old, 60% were men, and 31% had typical angina. Mean pre-test probability of obstructive CAD was 34%. Overall prevalence of obstructive CAD was 37.7% on the index angiographic procedure. In the CCTA group, ICA was cancelled by referring physicians in 83 patients (72.2%) after receiving CCTA results. For those undergoing ICA, diagnostic (84.4% vs. 41.7%, p<0.001) and revascularization (71.9% vs. 38.8%, p = 0.001) yields were significantly higher for CCTA-guided ICA than for standard NIST-guided ICA. Mean cumulative radiation exposure was significantly lower in the CCTA-guided ICA arm than in the NIST-guided ICA arm (12 ± 9 vs. 16 ± 10 mSv, respectively, p = 0.024). There were no significant differences in the primary safety endpoint rates between the strategies (p = 0.439). In patients with suspected CAD and mild-to-moderately abnormal ischemia tests, a diagnostic strategy including CCTA as a gatekeeper is safe and effective and significantly improves diagnostic and revascularization yields of ICA.",2022,"Mean cumulative radiation exposure was significantly lower in the CCTA-guided ICA arm than in the NIST-guided ICA arm (12 ± 9 vs. 16 ± 10 mSv, respectively, p = 0.024).","['patients were 69 ± 9 years old, 60% were men, and 31% had typical angina', 'patients with suspected stable coronary artery disease (CAD', '220 symptomatic patients with mild-to-moderately abnormal NIST results who were referred for ICA']","['Cardiac computed tomographic angiography', 'originally intended ICA', 'CCTA', 'systematic coronary computed tomographic angiography (CCTA']","['Overall prevalence of obstructive CAD', 'diagnostic yield of ICA', 'Mean cumulative radiation exposure', 'ICA', 'primary safety endpoint rates', 'Mean pre-test probability of obstructive CAD', 'revascularization', 'Revascularization yield and major adverse cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1998435', 'cui_str': 'Typical angina'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",220.0,0.0911958,"Mean cumulative radiation exposure was significantly lower in the CCTA-guided ICA arm than in the NIST-guided ICA arm (12 ± 9 vs. 16 ± 10 mSv, respectively, p = 0.024).","[{'ForeName': 'João Ferreira', 'Initials': 'JF', 'LastName': 'Reis', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, nº 50, 1169-024, Lisbon, Portugal. jpr_911@hotmail.com.'}, {'ForeName': 'Ruben Baptista', 'Initials': 'RB', 'LastName': 'Ramos', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, nº 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Marques', 'Affiliation': 'Department of Radiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, Lisbon, Portugal.'}, {'ForeName': 'Pedro Modas', 'Initials': 'PM', 'LastName': 'Daniel', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, nº 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Sílvia Rosa', 'Initials': 'SR', 'LastName': 'Aguiar', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, nº 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Luís Almeida', 'Initials': 'LA', 'LastName': 'Morais', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, nº 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Madalena Coutinho', 'Initials': 'MC', 'LastName': 'Cruz', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, nº 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Rita Ilhão', 'Initials': 'RI', 'LastName': 'Moreira', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, nº 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'André Viveiros', 'Initials': 'AV', 'LastName': 'Monteiro', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, nº 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Duarte', 'Initials': 'D', 'LastName': 'Cacela', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, nº 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Luísa', 'Initials': 'L', 'LastName': 'Figueiredo', 'Affiliation': 'Department of Radiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, Lisbon, Portugal.'}, {'ForeName': 'Rui Cruz', 'Initials': 'RC', 'LastName': 'Ferreira', 'Affiliation': 'Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central, nº 50, 1169-024, Lisbon, Portugal.'}]",The international journal of cardiovascular imaging,['10.1007/s10554-021-02426-6']
2663,35226083,Quality of Life Following Receipt of Adjuvant Chemotherapy With and Without Bevacizumab in Patients With Lymph Node-Positive and High-Risk Lymph Node-Negative Breast Cancer.,"Importance


Breast cancer treatment can impact not only short-term health but may also affect longer-term quality of life (QOL).
Objective


To describe and evaluate factors associated with diminished QOL following completion of active treatment.
Design, Setting, and Participants


This was a secondary analysis of a randomized clinical trial included patients with lymph node-positive or high-risk lymph node-negative breast cancer who had undergone definitive surgery and were enrolled in ECOG-ACRIN E5103, a multisite phase 3 trial. A survey was administered 18 months after enrollment to patients enrolled between January and June 2010. Final analysis of the data took place from March to December 2021.
Interventions


Patients received adjuvant doxorubicin, cyclophosphamide, and paclitaxel with either bevacizumab or placebo.
Main Outcomes and Measures


QOL and health status assessed with the EuroQol 5-Dimension 3-Levels (EQ-5D-3L), EQ-visual analog scale (EQ-VAS), and the Functional Assessment of Cancer Therapy-Breast Cancer, with arm subscale (FACT-B+4). Groups were compared by Fisher exact test, Wilcoxon rank sum, or Kruskal-Wallis test. Multivariable linear regression was used to assess factors independently associated with FACT-B scores.
Results


Data at 18 months were available from 455 of 519 patients (87.7%) enrolled in the trial. Median (range) age at enrollment was 52 (25-76) years. No differences in QOL (median [range] FACT-B scores: group A, 123 [67-146]; group B, 114 [54-148]; group C, 117 [42-148]; P = .23) or health status (median [range] EQ-5D-3L index scores: group A, 0.83 [0.28-1.00]; group B, 0.83 [0.20-1.00]; group C, 0.83 [0.17-1.00], P = .80; median EQ-VAS: group A, 85 [20-100]; group B, 85 [0-100]; group C, 85 [0-100]; P = .79) were observed across treatment groups; results for subsequent analyses were therefore reported irrespective of primary treatment. Overall, half of patients (258 of 444 [58%]) reported at least some pain or discomfort; 170 (38%) reported symptoms of anxiety or depression. In multivariable analyses, mastectomy with radiation (vs breast conserving surgery) and Asian, Black, or American Indian or Alaska Native race (vs White race) were associated with lower QOL (mastectomy with radiation: coefficient: -5.5; 95% CI, -10.1 to -0.9; Asian, Black, or American Indian or Alaska Native race: coefficient: -7.3; 95% CI, -13.2, -1.4).
Conclusions and Relevance


In this study, the addition of bevacizumab to chemotherapy was not negatively associated with QOL at 18 months. A substantial proportion of participants reported problems related to pain or discomfort and anxiety or depression, demonstrating persistent consequences for physical and psychosocial well-being in this heavily treated population. Many problems reported are amenable to intervention, underscoring the need for timely referral to supportive resources, especially for women of color and those who have more extensive local therapy.
Trial Registration


ClinicalTrials.gov Identifier: NCT00433511.",2022,"EQ-5D-3L index scores: group A, 0.83 [0.28-1.00]; group B, 0.83","['Patients With Lymph Node-Positive and High-Risk Lymph Node-Negative Breast Cancer', 'patients with lymph node-positive or high-risk lymph node-negative breast cancer who had undergone definitive surgery and were enrolled in ECOG-ACRIN E5103, a multisite phase 3 trial', 'Results\n\n\nData at 18 months were available from 455 of 519 patients (87.7%) enrolled in the trial', 'Native race: coefficient']","['bevacizumab', 'Bevacizumab', 'Adjuvant Chemotherapy', 'mastectomy with radiation (vs breast conserving surgery) and Asian, Black, or American Indian or Alaska', 'adjuvant doxorubicin, cyclophosphamide, and paclitaxel with either bevacizumab or placebo']","['EQ-5D-3L index scores', 'health status', 'longer-term quality of life (QOL', 'Measures\n\n\nQOL and health status assessed with the EuroQol 5-Dimension 3-Levels (EQ-5D-3L), EQ-visual analog scale (EQ-VAS), and the Functional Assessment of Cancer Therapy-Breast Cancer, with arm subscale (FACT-B+4', 'QOL (median [range', 'Quality of Life', 'pain or discomfort', 'symptoms of anxiety or depression', 'pain or discomfort and anxiety or depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0001905', 'cui_str': 'Alaska'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.216987,"EQ-5D-3L index scores: group A, 0.83 [0.28-1.00]; group B, 0.83","[{'ForeName': 'Shoshana M', 'Initials': 'SM', 'LastName': 'Rosenberg', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""O'Neill"", 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sepucha', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University, Indianapolis.'}, {'ForeName': 'Chau T', 'Initials': 'CT', 'LastName': 'Dang', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Northfelt', 'Affiliation': 'Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Indiana University, Indianapolis.'}, {'ForeName': 'Bryan P', 'Initials': 'BP', 'LastName': 'Schneider', 'Affiliation': 'Indiana University, Indianapolis.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.0254']
2664,35226082,Effect of Electronic Portal Messaging With Embedded Asynchronous Care on Physician-Assisted Smoking Cessation Attempts: A Randomized Clinical Trial.,"Importance


Despite the substantial health and financial burdens of smoking and the availability of effective, evidence-based interventions in primary care settings, few smokers and physicians use these strategies for smoking cessation.
Objective


To evaluate whether electronic outreach to smokers with embedded asynchronous care increases the number of quit attempts and explore the roles of the message sender (ie, primary care physician [PCP] vs health care system) and patient-related characteristics.
Design, Setting, and Participants


This quality improvement randomized clinical trial was designed to measure 2 factors: (1) electronic outreach messaging with and without a survey link to asynchronous care and (2) messaging by a personal PCP or health system. The study was conducted within the electronic health record and portal messaging platform of a large health system in the South Central US. Participants were adult patients 18 years or older who were designated as smokers in their electronic health records. Data were collected from January 13 to February 24, 2020, with participating PCPs surveyed in July 2020.
Interventions


Portal messages encouraging a quit attempt and offering physician assistance were sent to smokers who were randomly selected and assigned to 1 of 4 conditions (message with or without embedded asynchronous care and PCP or system as sender). Half of the messages contained an invitation to come to clinics and the other half contained a link to access asynchronous care.
Main Outcomes and Measures


The primary outcome was electronic health record-documented quit attempts (1 indicates quit attempt; 0, no quit attempt), which were tracked 30 days after the electronic outreach. Secondary outcomes included physician perceptions of the electronic outreach intervention, using a 5-point scale to assess perceptions of workload, comfort with providing medication from survey information, and further interest in the program 6 months after the intervention.
Results


A total of 188 participants (99 women [52.4%] and 89 men [47.3%]) with mean (SD) age of 55.2 (13.9) years were randomized to 1 of 4 conditions. Group 1 (n = 46) received a message from the PCP without a link to the survey; group 2 (n = 48) received a message from the PCP with a link to asynchronous care in the form of the survey. Group 3 (n = 47) received a message from the health system without a link to the survey; group 4 (n = 47) received a message from the health system with a link to the survey. No statistically significant difference in documented quite attempts was found among the 4 study groups. There was also no statistically significant difference in quit attempts between the group that received the asynchronous care survey link and the group that did not (odds ratio, 2.50 [95% CI, 0.72-8.72]). However, the quit attempt rate for those with asynchronous care offered (9 of 95 [9.5%]) was more than double the quit attempt rate for those with in-person care offered (4 of 93 [4.3%]).
Conclusions and Relevance


This quality improvement randomized clinical trial did not find a statistically significant difference in physician-assisted quit attempts among patients who received electronic with asynchronous care vs those who received outreach alone, regardless of whether the message source was a PCP or a health system. However, the program engaged patients in difficult-to-reach rural areas as well as younger patients.
Trial Registration


ClinicalTrials.gov Identifier: NCT05172219.",2022,"There was also no statistically significant difference in quit attempts between the group that received the asynchronous care survey link and the group that did not (odds ratio, 2.50 [95% CI, 0.72-8.72]).","['Physician-Assisted Smoking Cessation Attempts', '188 participants (99 women [52.4%] and 89 men [47.3%]) with mean (SD) age of 55.2 (13.9) years', 'Data were collected from January 13 to February 24, 2020, with participating PCPs surveyed in July 2020', 'Participants were adult patients 18 years or older who were designated as smokers in their electronic health records']","['Electronic Portal Messaging With Embedded Asynchronous Care', 'electronic outreach messaging with and without a survey link to asynchronous care and (2) messaging by a personal PCP or health system', '4 conditions (message with or without embedded asynchronous care\u2009and PCP or system as sender', 'message from the health system without a link to the survey; group 4 (n = 47) received a message from the health system with a link to the survey', 'electronic outreach']","['electronic health record-documented quit attempts (1\u2009indicates\u2009quit attempt; 0,\u2009no quit attempt', 'physician-assisted quit attempts', 'quit attempt rate', 'physician perceptions of the electronic outreach intervention, using a 5-point scale to assess perceptions of workload, comfort with providing medication from survey information, and further interest', 'quit attempts']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",188.0,0.184776,"There was also no statistically significant difference in quit attempts between the group that received the asynchronous care survey link and the group that did not (odds ratio, 2.50 [95% CI, 0.72-8.72]).","[{'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Erdmann', 'Affiliation': 'Center for Health Systems Innovation, Spears School of Business, Oklahoma State University, Tulsa.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Edwards', 'Affiliation': 'Department of Management, Spears School of Business, Oklahoma State University, Tulsa.'}, {'ForeName': 'Mopileola Tomi', 'Initials': 'MT', 'LastName': 'Adewumi', 'Affiliation': 'College of Osteopathic Medicine, Center for Health Sciences, Oklahoma State University, Tulsa.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.0348']
2665,35226081,"Effect of S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Plus Oxaliplatin as Perioperative Chemotherapy for Locally Advanced, Resectable Gastric Cancer: A Randomized Clinical Trial.","Importance


Perioperative chemotherapy is a potential treatment for locally advanced gastric cancer. However, the optimal chemotherapy regimen remains unknown.
Objective


To investigate the safety and efficacy of S-1 plus oxaliplatin (SOX) vs fluorouracil, leucovorin, and oxaliplatin (FOLFOX) as a perioperative chemotherapy regimen for patients with locally advanced gastric cancer.
Design, Setting, and Participants


In this phase 3, open-label, multicenter, randomized clinical trial, patients from 12 Chinese hospitals were enrolled between June 2011 and August 2016, with a last follow-up date of September 2019. The primary tumor was evaluated as either invading the serosa or the adjacent structures with or without metastatic lymph nodes, and with no evidence of distant metastases. Data were analyzed from December 2019 to June 2020.
Interventions


Patients were randomly assigned (1:1) to receive either 6 perioperative (2-4 preoperative and 2-4 postoperative) 3-week cycles of 130 mg/m2 oxaliplatin on day 1 and 80 to 120 mg/d S-1 orally daily for 2 weeks (SOX) or 130 mg/m2 oxaliplatin, 400 mg/m2 fluorouracil, 400 mg/m2 leucovorin, and 2400 mg/m2 fluorouracil as 46-hour infusion on day 1 (FOLFOX).
Main Outcomes and Measures


The primary end point was 3-year overall survival (OS). An absolute noninferiority margin of -8% was chosen.
Results


A total of 583 patients were enrolled; 293 were randomized to the SOX group and 290 were randomized to the FOLFOX group. Twelve patients (2.1%) refused preoperative chemotherapy (5 patients in the SOX group and 7 patients in the FOLFOX group), leaving a total of 288 patients in the SOX group (median [range] age, 61 [24 to 78] years; 197 men [68.4%]) and 283 patients in the FOLFOX group (median [range] age, 62 [24 to 80] years; 209 men [73.9%]) who received preoperative chemotherapy. The 3-year OS rate was 75.2% (95% CI, 70.3% to 80.5%) in the SOX group and 67.8% (95% CI, 62.5% to 73.5%) in the FOLFOX group. The absolute difference of 3-year OS rate between the 2 groups was 7.4% (95% CI, -0.1% to 14.9%), which was greater than the prespecified noninferiority margin (-8%) and showed the noninferiority of perioperative chemotherapy with SOX compared with FOLFOX.
Conclusions and Relevance


In this randomized clinical trial, SOX was noninferior to FOLFOX as perioperative chemotherapy for patients with locally advanced gastric cancer and could be recommended as an alternative treatment for these patients in Asia.
Trial Registration


ClinicalTrials.gov Identifier: NCT01364376.",2022,"The absolute difference of 3-year OS rate between the 2 groups was 7.4% (95% CI, -0.1% to 14.9%), which was greater than the prespecified noninferiority margin (-8%) and showed the noninferiority of perioperative chemotherapy with SOX compared with FOLFOX.
","['A total of 583 patients were enrolled; 293', 'patients from 12 Chinese hospitals were enrolled between June 2011 and August 2016, with a last follow-up date of September 2019', 'Locally Advanced, Resectable Gastric Cancer', 'Twelve patients (2.1%) refused preoperative chemotherapy (5 patients in the SOX group and 7 patients in the FOLFOX group), leaving a total of 288 patients in the SOX group (median [range] age, 61 [24 to 78] years; 197 men [68.4%]) and 283 patients in the FOLFOX group (median [range] age, 62 [24 to 80] years; 209 men [73.9%]) who received preoperative chemotherapy', 'locally advanced gastric cancer', 'patients with locally advanced gastric cancer']","['FOLFOX', 'S-1 Plus Oxaliplatin', 'S-1 plus oxaliplatin (SOX) vs fluorouracil, leucovorin, and oxaliplatin (FOLFOX', 'Fluorouracil, Leucovorin Plus Oxaliplatin', 'SOX', 'oxaliplatin, 400 mg/m2 fluorouracil, 400 mg/m2 leucovorin, and 2400 mg/m2 fluorouracil', '6 perioperative (2-4 preoperative and 2-4 postoperative) 3-week cycles of 130 mg/m2 oxaliplatin']","['safety and efficacy', '3-year OS rate', '3-year overall survival (OS']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191355', 'cui_str': '583'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4708786', 'cui_str': '283'}]","[{'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",583.0,0.203265,"The absolute difference of 3-year OS rate between the 2 groups was 7.4% (95% CI, -0.1% to 14.9%), which was greater than the prespecified noninferiority margin (-8%) and showed the noninferiority of perioperative chemotherapy with SOX compared with FOLFOX.
","[{'ForeName': 'Jiren', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Qianyun', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Zhicheng', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Weihuai', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of General Surgery, Beilun District People's Hospital, Ningbo, China.""}, {'ForeName': 'Hanliang', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, Zhejiang Provincial Hospital of Chinese Medicine, Hangzhou, China.'}, {'ForeName': 'Xinbao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatopancreatobiliary Surgery, Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, The Central Hospital of Lishui City, Lishui, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Wenzhou Medical College, Wenzhou, China.'}, {'ForeName': 'Xianfa', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, The Sir Run Run Shaw Hospital, Medical School Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Hongjun', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital, Jinan, China.'}, {'ForeName': 'Zekuan', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Zhilong', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'Department of Gastrointestinal Surgery, Ningbo First Hospital, Ningbo, China.'}, {'ForeName': 'Yingjie', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Thyroid and Breast Surgery, The Affiliated People's Hospital of Ningbo University, Ningbo, China.""}, {'ForeName': 'Mingjuan', 'Initials': 'M', 'LastName': 'Jin', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Xiaosun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Kankai', 'Initials': 'K', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Chunhui', 'Initials': 'C', 'LastName': 'Shou', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.0426']
2666,35226080,Effectiveness of Acupuncture for Pain Control After Cesarean Delivery: A Randomized Clinical Trial.,"Importance


A pharmacological approach to pain control after cesarean delivery is often insufficient on its own. Acupuncture is a promising method for mitigating postoperative pain and reducing postoperative opioid requirements.
Objective


To evaluate the efficacy and effectiveness of acupuncture as an adjunctive therapy for pain control after cesarean delivery, compared with a placebo intervention and standard care alone.
Design, Setting, and Participants


This single-center, placebo-controlled, patient- and assessor-blinded randomized clinical trial was conducted from January 13, 2015, to June 27, 2018, at a tertiary university hospital in Greifswald, Germany. Participants were women who were scheduled for elective cesarean delivery under spinal anesthesia and were randomized to either the acupuncture group (n = 60) or placebo group (n = 60). Another 60 consecutive patients who met the eligibility criteria and received the standard postoperative analgesia were selected to form a nonrandomized standard care group. The intention-to-treat analysis was performed from August 19, 2019, to September 13, 2019.
Interventions


In addition to standard pain treatment, each patient in the acupuncture group received auricular and body acupuncture with indwelling intradermal needles, whereas patients in the placebo group were treated with nonpenetrating placebo needles.
Main Outcomes and Measures


The primary outcome was pain intensity on movement, which was measured using an 11-item verbal rating scale. Secondary outcomes were analgesia-related adverse effects, analgesics consumption, time to mobilization and Foley catheter removal, quality of patient blinding to randomization, and patient satisfaction with treatment of pain.
Results


A total of 180 female patients (mean [SD] age, 31 [5] years) were included in the intention-to-treat analysis. The mean pain intensity on movement in the acupuncture group on the first postoperative day was lower than in the placebo group (4.7 [1.8] vs 6.0 [2.0] points; Cohen d, 0.73; 95% CI, 0.31-1.01; P = .001) and the standard care group (6.3 [1.3] points; Cohen d, 1.01; 95% CI, 0.63-1.40; P < .001). On the first postoperative day, 59 patients (98%) in the acupuncture group were fully mobilized vs 49 patients (83%) in the placebo group (relative risk [RR], 1.18; 95% CI, 1.06-1.33; P = .01) and 35 patients (58%) in the standard care group (RR, 1.69; 95% CI, 1.36-2.09; P < .001). The Foley catheter was removed in a total of 57 patients (93%) from the acupuncture group vs 43 patients (72%) from the placebo group (RR, 1.33; 95% CI, 1.12-1.57; P = .003) and 42 patients (70%) from the standard care group (RR, 1.37; 95% CI, 1.14-1.62; P = .002). Other parameters were comparable across the 3 study groups.
Conclusions and Relevance


Results of this trial showed that acupuncture was safe and effective in reducing pain and accelerating mobilization of patients after cesarean delivery. With consideration for personnel and time expenditures, acupuncture can be recommended as routine, supplemental therapy for pain control in patients after elective cesarean delivery.
Trial Registration


ClinicalTrials.gov Identifier: NCT02364167.",2022,"The Foley catheter was removed in a total of 57 patients (93%) from the acupuncture group vs 43 patients (72%) from the placebo group (RR, 1.33; 95% CI, 1.12-1.57; P = .003) and 42 patients (70%) from the standard care group (RR, 1.37; 95% CI, 1.14-1.62; P = .002).","['January 13, 2015, to June 27, 2018, at a tertiary university hospital in Greifswald, Germany', 'patients after elective cesarean delivery', '60 consecutive patients who met the eligibility criteria and received the standard postoperative analgesia were selected to form a nonrandomized standard care group', '180 female patients (mean [SD] age, 31 [5] years) were included in the intention-to-treat analysis', 'Participants were women who were scheduled for elective cesarean delivery under spinal anesthesia']","['acupuncture', 'auricular and body acupuncture with indwelling intradermal needles', 'placebo', 'Acupuncture', 'placebo intervention and standard care alone', 'nonpenetrating placebo needles']","['analgesia-related adverse effects, analgesics consumption, time to mobilization and Foley catheter removal, quality of patient blinding to randomization, and patient satisfaction with treatment of pain', 'Pain Control', 'pain and accelerating mobilization', 'pain intensity on movement, which was measured using an 11-item verbal rating scale', 'Foley catheter', 'mean pain intensity', 'efficacy and effectiveness']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",180.0,0.778338,"The Foley catheter was removed in a total of 57 patients (93%) from the acupuncture group vs 43 patients (72%) from the placebo group (RR, 1.33; 95% CI, 1.12-1.57; P = .003) and 42 patients (70%) from the standard care group (RR, 1.37; 95% CI, 1.14-1.62; P = .002).","[{'ForeName': 'Taras I', 'Initials': 'TI', 'LastName': 'Usichenko', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Berthold Johannes', 'Initials': 'BJ', 'LastName': 'Henkel', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Klausenitz', 'Affiliation': 'Department of Radiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hesse', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Pierdant', 'Affiliation': 'Department of Gynecology and Obstetrics, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Cummings', 'Affiliation': 'British Medical Acupuncture Society, London, United Kingdom.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hahnenkamp', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.0517']
2667,32305186,Effect of total arterial grafting in the Arterial Revascularization Trial.,"OBJECTIVES


The Arterial Revascularization Trial (ART) was designed to compare 10-year survival in bilateral versus single internal thoracic artery grafts. The intention-to-treat analysis has showed comparable outcomes between the 2 groups but an explanatory analysis suggested that those receiving 2 or more arterial grafts had better survival. Whether the exclusive use of arterial grafts provide further benefit is unclear.
METHODS


We performed an exploratory analysis of the ART based on conduits actually received (as-treated principle). From ART cohort, only patients receiving at least 3 grafts were included. The final population consisted of 1084, 1010, and 390 patients in the single arterial graft (SAG) group, in the multiple arterial graft (MAG) group (2 or more arterial grafts with additional saphenous veins) and total arterial graft (TAG) group (3 or more arterial grafts only) respectively. Inverse probability of treatment weighting was used for comparison.
RESULTS


When compared with the SAG group, there was a significant trend toward a reduction of 10-year mortality in the MAG and TAG group (test for trend P = .02). The TAG group was associated with the lowest risk of late mortality (hazard ratio, 0.68; 95% confidence interval, 0.48-0.96; P = .03) and with a significant risk reduction of the composite of death/myocardial infarction/stroke and repeat revascularization (hazard ratio, 0.71; 95% confidence interval, 0.53-0.94; P = .02).
CONCLUSIONS


When compared with SAG, both MAG and TAG represent valuable strategies to improve clinical outcomes following coronary artery bypass grafting but TAG can potentially provide further benefit.",2022,"The TAG group was associated with the lowest risk of late mortality (hazard ratio, 0.68; 95% confidence interval, 0.48-0.96; P = .03) and with a significant risk reduction of the composite of death/myocardial infarction/stroke and repeat revascularization (hazard ratio, 0.71; 95% confidence interval, 0.53-0.94; P = .02).
","['The final population consisted of 1084, 1010, and 390 patients in the single arterial graft (SAG) group, in the']","['multiple arterial graft (MAG) group (2 or more arterial grafts with additional saphenous veins) and total arterial graft (TAG', 'SAG', 'bilateral versus single internal thoracic artery grafts', 'total arterial grafting', 'SAG, both MAG and TAG']","['10-year survival', 'composite of death/myocardial infarction/stroke and repeat revascularization', 'survival', 'lowest risk of late mortality', '10-year mortality']","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450140', 'cui_str': 'Arterial graft'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0450140', 'cui_str': 'Arterial graft'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036186', 'cui_str': 'Saphenous vein structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0226276', 'cui_str': 'Structure of internal thoracic artery'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.119416,"The TAG group was associated with the lowest risk of late mortality (hazard ratio, 0.68; 95% confidence interval, 0.48-0.96; P = .03) and with a significant risk reduction of the composite of death/myocardial infarction/stroke and repeat revascularization (hazard ratio, 0.71; 95% confidence interval, 0.53-0.94; P = .02).
","[{'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Taggart', 'Affiliation': 'Nuffield Department of Surgical Sciences, John Radcliffe Hospital, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mario F', 'Initials': 'MF', 'LastName': 'Gaudino', 'Affiliation': 'Cardiothoracic Surgery at Weill Cornell Medical Center, New York, NY. Electronic address: mfg9004@med.cornell.edu.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gerry', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Department of Public Health, Health Economics Research Centre, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Lees', 'Affiliation': 'Nuffield Department of Surgical Sciences, John Radcliffe Hospital, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Arnaldo', 'Initials': 'A', 'LastName': 'Dimagli', 'Affiliation': 'School of Clinical Sciences, Bristol Heart Institute, University of Bristol, United Kingdom.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Puskas', 'Affiliation': 'Cardiothoracic Surgery at The Mount Sinai Hospital, New York, NY.'}, {'ForeName': 'Vipin', 'Initials': 'V', 'LastName': 'Zamvar', 'Affiliation': 'Department of Cardio-Thoracic Surgery, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Pawlaczyk', 'Affiliation': 'Medical University of Gdansk, Gdańsk, Poland.'}, {'ForeName': 'Alistair G', 'Initials': 'AG', 'LastName': 'Royse', 'Affiliation': 'Royal Melbourne Hospital, University of Melbourne, Australia.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Flather', 'Affiliation': 'Research and Development Unit, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, United Kingdom.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Benedetto', 'Affiliation': 'School of Clinical Sciences, Bristol Heart Institute, University of Bristol, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.03.013']
2668,34698889,Comparison of statins for primary prevention of cardiovascular disease and persistent physical disability in older adults.,"PURPOSE


Recent epidemiological evidence has suggested that use of lipid-lowering medications, particularly statins, was associated with reduced cardiovascular disease (CVD) events and persistent physical disability in healthy older adults. However, the comparative efficacy of different statins in this group remains unclear. This study aimed to compare different forms of statins in their associations with CVD and physical disability in healthy older adults.
METHODS


This post hoc analysis included data from 5981 participants aged ≥ 70 years (≥ 65 if US minorities; median age:74.0) followed for a median of 4.7 years, who had no prior CVD events or physical disability and reported using a statin at baseline. The incidence of the composite and components of major adverse cardiovascular events and persistent physical disability were compared across different statins according to their type, potency, and lipophilicity using multivariable Cox proportional-hazards models.
RESULTS


Atorvastatin was the most used statin type at baseline (37.9%), followed by simvastatin (29.6%), rosuvastatin (25.5%), and other statins (7.0%, predominantly pravastatin). In comparisons of specific statins according to type and lipophilicity (lipophilic vs. hydrophilic statin), observed differences in all outcomes were small and not statistically significant (all p values > 0.05). High-potency statin use (atorvastatin and rosuvastatin) was marginally associated with lower risk of fatal CVD events compared with low-/moderate-potency statin use (hazard ratio: 0.59; 95% confidence interval: 0.35, 1.00).
CONCLUSION


There were minimal differences in CVD outcomes and no significant difference in persistent physical disability between various forms of statins in healthy older adults. Future investigations are needed to confirm our results.",2022,There were minimal differences in CVD outcomes and no significant difference in persistent physical disability between various forms of statins in healthy older adults.,"['5981 participants aged\u2009≥', 'older adults', '70\xa0years (≥\u200965 if US minorities; median age:74.0) followed for a median of 4.7\xa0years, who had no prior CVD events or physical disability and reported using a statin at baseline', 'healthy older adults']","['rosuvastatin', 'Atorvastatin', 'simvastatin', 'atorvastatin and rosuvastatin', 'statins']","['CVD outcomes', 'lower risk of fatal CVD events', 'persistent physical disability', 'incidence of the composite and components of major adverse cardiovascular events and persistent physical disability']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",5981.0,0.0415922,There were minimal differences in CVD outcomes and no significant difference in persistent physical disability between various forms of statins in healthy older adults.,"[{'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, TAS, 17 Liverpool Street, Hobart, 7000, Australia. zhen.zhou@utas.edu.au.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Curtis', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, The University of Iowa, Iowa, IA, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Zoungas', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Division of Geriatrics, Department of Medicine Hennepin HealthCare, Hennepin Healthcare Research Institute, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Enayet K', 'Initials': 'EK', 'LastName': 'Chowdhury', 'Affiliation': 'School of Public Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tonkin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, TAS, 17 Liverpool Street, Hobart, 7000, Australia.'}]",European journal of clinical pharmacology,['10.1007/s00228-021-03239-1']
2669,34773130,"Nonsteroidal anti-inflammatory drug-sparing effect of secukinumab in patients with radiographic axial spondyloarthritis: 4-year results from the MEASURE 2, 3 and 4 phase III trials.","Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to reduce pain and inflammation, and are considered the cornerstone of pharmacological intervention in patients with radiographic axial spondyloarthritis (r-axSpA); however, the long-term use of NSAIDs is debatable due to their restricted therapeutic potential and the risk of side effects and complications. Therefore, reduction in NSAID intake is desirable in r-axSpA patients. Here, we report the long-term NSAID-sparing effect of secukinumab over 4 years in patients with r-axSpA. This post hoc analysis pooled data from 3 secukinumab trials (MEASURE 2-4) for each secukinumab maintenance dose of 150 and 300 mg, regardless of the loading dose regimen being i.v. or s.c. NSAID intake was evaluated prospectively using the Assessment of SpondyloArthritis International Society (ASAS)-NSAID score. Patients with an ASAS-NSAID score > 0 at baseline were analysed. NSAID-sparing endpoints included the mean change in the ASAS-NSAID score, the proportion of patients achieving 50% reduction, and the proportion of patients with an ASAS-NSAID score < 10. Percentages of patients who achieved BASDAI ≤ 2 were also assessed. Overall, 562 patients were included in this pooled analysis (secukinumab: 150 mg, N = 467; 300 mg, N = 95). The mean ASAS-NSAID score decreased with time in both the secukinumab 150 mg and 300 mg dose groups. The proportion of patients who achieved 50% reduction in the ASAS-NSAID score and clinically meaningful reduction of ASAS-NSAID score < 10 increased with time in both dose groups and in both low and high NSAID intake patients. The percentage of patients with a clinically relevant improvement (BASDAI ≤ 2) was consistently higher in patients with an ASAS-NSAID score < 10 than in patients with an ASAS-NSAID score ≥ 10. Secukinumab provided sustained, long-term NSAID-sparing effects in patients with r-axSpA for up to 4 years of treatment, as measured using the ASAS-NSAID score. Trial registered at clinicaltrials.gov: NCT01649375 ( https://clinicaltrials.gov/ct2/show/NCT01649375 ); NCT02008916 ( https://clinicaltrials.gov/ct2/show/NCT02008916 ); NCT02159053 ( https://clinicaltrials.gov/ct2/show/NCT02159053 ).",2022,The mean ASAS-NSAID score decreased with time in both the secukinumab 150 mg and 300 mg dose groups.,"['562 patients were included in this pooled analysis (secukinumab: 150\xa0mg, N\u2009=\u2009467; 300\xa0mg, N\u2009=\u200995', 'patients with radiographic axial spondyloarthritis (r-axSpA', 'patients with radiographic axial spondyloarthritis', 'Patients with an ASAS-NSAID score\u2009>\u20090 at baseline were analysed', 'patients with r-axSpA']","['secukinumab', 'Nonsteroidal anti-inflammatory drugs (NSAIDs']","['mean ASAS-NSAID score', 'ASAS-NSAID score and clinically meaningful reduction of ASAS-NSAID score', 'NSAID intake', 'ASAS-NSAID score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4517784', 'cui_str': '467'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",562.0,0.156145,The mean ASAS-NSAID score decreased with time in both the secukinumab 150 mg and 300 mg dose groups.,"[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Department of Rheumatology, Université de Paris, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France. maxime.dougados@aphp.fr.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Kiltz', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Herne, Germany.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, USA.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Pavelka', 'Affiliation': 'Department of Rheumatology, Institute of Rheumatology, Prague, Czech Republic.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Rohrer', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'McCreddin', 'Affiliation': 'Novartis Ireland Ltd, Dublin, Ireland.'}, {'ForeName': 'Erhard', 'Initials': 'E', 'LastName': 'Quebe-Fehling', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Porter', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Talloczy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}]",Rheumatology international,['10.1007/s00296-021-05044-6']
2670,34939180,"Innovative Pediatric Development for Secukinumab in Psoriasis: Faster Patient Access, Reduction of Patients on Control.","This paper describes the innovative pediatric development strategy of secukinumab in psoriasis. Initially, this pediatric development had been planned early during the adult development program. This is common for most development programs as it is required by law in major regions worldwide. At that time, only limited experience with secukinumab's mechanism of action was available, especially in the pediatric population for which no data had been collected yet. Pediatric extrapolation frameworks were not in use. As a result, a standard pediatric program had initially been proposed requiring two relatively large placebo-controlled pivotal trials. However, as experience with the use of secukinumab grew, so did experience with-and regulatory openness to-innovative quantitative approaches, such as extrapolation. It became clear that the pediatric development of secukinumab could be substantially accelerated by these novel ideas. Here, we report how these concepts were implemented in the pediatric development program of secukinumab in psoriasis, using a wide range of innovative quantitative techniques. This strategy led to the removal of the placebo arm from one trial, a substantial reduction of the overall sample size in this program, and a significantly faster approval of secukinumab for the pediatric psoriasis population.",2022,"This strategy led to the removal of the placebo arm from one trial, a substantial reduction of the overall sample size in this program, and a significantly faster approval of secukinumab for the pediatric psoriasis population.",['Secukinumab in Psoriasis'],['placebo'],[],"[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.124339,"This strategy led to the removal of the placebo arm from one trial, a substantial reduction of the overall sample size in this program, and a significantly faster approval of secukinumab for the pediatric psoriasis population.","[{'ForeName': 'Ruquan', 'Initials': 'R', 'LastName': 'You', 'Affiliation': 'Analytics, Novartis Institutes for Biomedical Research, Shanghai, China.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': 'Analytics, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bieth', 'Affiliation': 'Analytics, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Vandemeulebroecke', 'Affiliation': 'Analytics, Novartis Pharma AG, Basel, Switzerland.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2518']
2671,35222189,Evaluation of a Smartphone Application on the Reduction of Attentional Bias Toward Alcohol Among Students † .,"Context


The recent development of ""serious games"" has produced encouraging results in maintaining adherence to health-related interventions. In alcohol research, several studies have shown that computerized training on attentional bias decreases alcohol consumption bias among students. However, these highly controlled experimental situations, do not allow for direct large-scale dissemination. Our objective is to evaluate an attentional bias remediation program using a gamified smartphone training procedure.
Methods


Fifty students from Clermont-Ferrand University were invited to participate in the study. After a cognitive assessment in the laboratory, the smartphone application was installed on each Student's smartphone. Participants were randomly assigned to either the alcohol attentional training group or the control group Each student had to complete the 2-min program at least once a day for 15 days. After 15 days, a new cognitive assessment of attention bias was conducted in the laboratory. Forty-seven students were included in the study.
Results


Our analyses did not show any effect of the cognitive remediation program on attentional bias reduction between the two group [ F   (1, 44)  < 1,  p  = 0.87], attentional performance [ F   (1, 45)  = 1.63,  p  = 0.20] or inhibitory abilities [ F   (1, 45)  < 1,  p  = 0.73]. These results were confirmed by Bayesian analyses.
Discussion


Despite the absence of group effects, both the alcohol and control (non-alcohol) version of this program appeared to reduce attentional bias and increase inhibition capacities in the subset of participants who had attentional bias for alcohol at baseline This pilot study identifies areas for improvement in smartphone applications for future developments. Attentional bias remediation programs remain an interesting way to explore.",2022,"Our analyses did not show any effect of the cognitive remediation program on attentional bias reduction between the two group [ F   (1, 44)  < 1,  p  = 0.87], attentional performance [ F   (1, 45)  = 1.63,  p  = 0.20] or inhibitory abilities [ F   (1, 45)  < 1,  p  = 0.73].","['Forty-seven students were included in the study', 'Methods\n\n\nFifty students from Clermont-Ferrand University were invited to participate in the study', 'participants who had attentional bias for alcohol at baseline']","['Smartphone Application', 'alcohol attentional training']","['attentional bias reduction', 'inhibitory abilities', 'attentional bias and increase inhibition capacities', 'Reduction of Attentional Bias Toward Alcohol', 'attentional performance']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]",47.0,0.00699807,"Our analyses did not show any effect of the cognitive remediation program on attentional bias reduction between the two group [ F   (1, 44)  < 1,  p  = 0.87], attentional performance [ F   (1, 45)  = 1.63,  p  = 0.20] or inhibitory abilities [ F   (1, 45)  < 1,  p  = 0.73].","[{'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Flaudias', 'Affiliation': 'Université de Nantes, Univ Angers, Laboratoire de Psychologie des Pays de la Loire, LPPL, EA 4638, Nantes, France.'}, {'ForeName': 'Oulmann', 'Initials': 'O', 'LastName': 'Zerhouni', 'Affiliation': 'Laboratoire Parisien de Psychologie Sociale, Département de Psychologie, Nanterre, France.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Chakroun-Baggioni', 'Affiliation': 'Université Clermont Auvergne, Laboratoire de Psychologie Sociale et Cognitive, Clermont-Ferrand, France.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'De Chazeron', 'Affiliation': 'CMP-B CHU, Clermont Auvergne INP, Institut Pascal, Centre National de la Recherche Scientifique (CNRS), Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Pierre-Michel', 'Initials': 'PM', 'LastName': 'Llorca', 'Affiliation': 'CMP-B CHU, Clermont Auvergne INP, Institut Pascal, Centre National de la Recherche Scientifique (CNRS), Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Brousse', 'Affiliation': 'CMP-B CHU, Clermont Auvergne INP, Institut Pascal, Centre National de la Recherche Scientifique (CNRS), Université Clermont Auvergne, Clermont-Ferrand, France.'}]",Frontiers in psychology,['10.3389/fpsyg.2022.790030']
2672,35222180,Pilot Study on the Effects of the Teaching Interpersonal Skills Program for Teens Program (PEHIA).,"Background/Objective


Social skills are essential in adolescence, both for their relational dimension and for their influence on other areas of adolescent life, so it is essential to include Social skills in the formal education of students.
Method


This paper presents the results of an experimental mixed factorial design pilot study in which an Interpersonal Skills Training Program for Adolescents (PEHIA) was applied. The convenience sample consisted of 51 adolescents. An evaluation was carried out before and after the intervention, using the CEDIA (Adolescent Interpersonal Difficulties Assessment Questionnaire) and SAS-A (Social Anxiety Scale for Adolescents) questionnaires.
Results


The mixed factorial ANOVA show significant differences in the overall measures and in most of the subscales of both questionnaires, indicating that PEHIA is effectiveness, at least in the short term.
Conclusions


The results obtained in assertiveness, interpersonal relationships and public speaking suggest that the program is feasible and shows promising results in reducing anxiety. However, a larger scale study should be conducted.",2022,"The mixed factorial ANOVA show significant differences in the overall measures and in most of the subscales of both questionnaires, indicating that PEHIA is effectiveness, at least in the short term.
","['Teens Program (PEHIA', '51 adolescents', 'Adolescents (PEHIA']","['Teaching Interpersonal Skills Program', 'Interpersonal Skills Training Program']",['CEDIA (Adolescent Interpersonal Difficulties Assessment Questionnaire) and SAS-A (Social Anxiety Scale for Adolescents) questionnaires'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",51.0,0.00462184,"The mixed factorial ANOVA show significant differences in the overall measures and in most of the subscales of both questionnaires, indicating that PEHIA is effectiveness, at least in the short term.
","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Serrano-Pintado', 'Affiliation': 'Departamento de Personalidad, Evaluación y Tratamiento Psicológicos, Universidad de Salamanca, Salamanca, Spain.'}, {'ForeName': 'María-Camino', 'Initials': 'MC', 'LastName': 'Escolar-Llamazares', 'Affiliation': 'Departamento de Ciencias de la Salud, Universidad de Burgos, Burgos, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Delgado-Sánchez-Mateos', 'Affiliation': 'Departamento de Psicología Básica, Psicobiología y Metodología de las Ciencias del Comportamiento, Universidad de Salamanca, Salamanca, Spain.'}]",Frontiers in psychology,['10.3389/fpsyg.2022.764926']
2673,35222137,Mental-Imagery-Based Mnemonic Training: A New Kind of Cognitive Training.,"We investigated the immediate and maintenance effects of mental-imagery-based mnemonic training on improving youths' working memory, long-term memory, arithmetic and spatial abilities, and fluid intelligence. In Experiment 1, 26 Chinese participants (15 boys, 11 girls) aged 10-16 years were divided into an experimental group that received 8 days of mental-imagery-based mnemonic training and a no-contact control group. Participants completed pre-, post-, and three follow-up tests (3, 6, and 12 months after the pre-test). In Experiment 2, 54 Chinese children (28 boys, 26 girls), all 12 years old, were divided into experimental and control groups. Participants completed pre-, post-, and follow-up tests (three months after the pre-test). Results showed that the training significantly affected long-term memory-related task performance but no effects were observed on working memory, arithmetic or spatial ability, or fluid intelligence-related tasks. Moreover, the effect of the training on long-term memory lasted up to one year; the more frequently the training was used, the more effective it was. A content analysis of the feedback submitted by parents of participants in Experiment 2 three months after the training showed that the children used the strategy more for memorizing content such as Chinese and English, as well as for musical scores. Furthermore, there was also the possibility that the training improved abilities and academic performance such as concentration and math performance. Our results provide a basis for the further exploration of mental-imagery-based mnemonic training as a novel training modality.",2021,"Results showed that the training significantly affected long-term memory-related task performance but no effects were observed on working memory, arithmetic or spatial ability, or fluid intelligence-related tasks.","['26 Chinese participants (15 boys, 11 girls) aged 10-16 years', '54 Chinese children (28 boys, 26 girls), all 12 years old']","['Mental-Imagery-Based Mnemonic Training', 'mental-imagery-based mnemonic training', 'mental-imagery-based mnemonic training and a no-contact control group']","['abilities and academic performance such as concentration and math performance', ""youths' working memory, long-term memory, arithmetic and spatial abilities, and fluid intelligence"", 'working memory, arithmetic or spatial ability, or fluid intelligence-related tasks', 'long-term memory-related task performance']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0423909', 'cui_str': 'Long-term memory performance'}, {'cui': 'C0679024', 'cui_str': 'Spatial Ability'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",54.0,0.00559968,"Results showed that the training significantly affected long-term memory-related task performance but no effects were observed on working memory, arithmetic or spatial ability, or fluid intelligence-related tasks.","[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Luan', 'Affiliation': 'Graduate School of Human Sciences, Waseda University, Tokorozawa, Japan.'}, {'ForeName': 'Yayoi', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Faculty of Human Sciences, Waseda University, Tokorozawa, Japan.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Medical College, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Sugimori', 'Affiliation': 'Faculty of Human Sciences, Waseda University, Tokorozawa, Japan.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.740829']
2674,35222036,"First-In-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SHR2285, a Small-Molecule Factor XIa Inhibitor in Healthy Subjects.","Background:  Targeting factor XI (FXI) is a promising therapeutic strategy for the treatment and prevention of thrombosis without increasing the risk of bleeding. Here, we assessed the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of SHR2285, a novel FXIa inhibitor, in healthy subjects.  Methods:  In this randomized, double-blinded, placebo-controlled, dose-ascending single-dosing trial (NCT03769831), eligible volunteer subjects receive either SHR2285 or placebo in a 3:1 ratio. Subjects assigned to the SHR2285 group received a single oral dose of SHR2285 at 50 mg, which was subsequently escalated to 100 mg, 200 mg, and 400 mg. Safety, pharmacokinetics, and pharmacodynamics parameters were assessed. All subjects were followed for 6 days.  Results:  SHR2285 was well tolerated. All adverse events were grade 1, and there was no evidence of bleeding events. The PK results revealed a rapid onset of action of SHR2285 (median time to maximum plasma concentration [T max ] in different dose groups ranged 3.0-4.0 h) and the mean half-life ranged from 7.6 to 15.8 h. The metabolite SHR164471 had a slightly longer T max  than the parent SHR2285, reaching a peak at a median of 6.0-7.0 h, and its mean half-life were 10.1-14.7 h in different dose groups. The sums of the area under the concentration-time curve from zero to time infinity of SHR2285 and SHR164471 in the 200 and 400 mg groups were similar, indicating the sum pharmacological activity of SHR2285 and SHR164471 showed a saturation trend between 200 and 400 mg. PD analysis showed that the inhibition of FXI activity was synchronized with prolonged activated partial thromboplastin time after SHR2285 administration, but the serum prothrombin time and international normalized ratio levels were not affected by SHR2285.  Conclusion:  SHR2285 demonstrated favorable safety, PK, and PD profiles in the dose range of 50 mg-400 mg. This first-in-human study supports the further development of SHR2285 for indications requiring anticoagulation.  Clinical Trial Registration : https://clinicaltrials.gov/ct2/show/NCT03769831, identifier [NCT03769831].",2022,"All adverse events were grade 1, and there was no evidence of bleeding events.","['Healthy Subjects', 'healthy subjects', 'eligible volunteer subjects receive either']","['SHR2285 or placebo', 'placebo', 'SHR2285', ':  Targeting factor XI (FXI']","['tolerated', 'safety, pharmacokinetics (PK), and pharmacodynamics (PD) of SHR2285, a novel FXIa inhibitor', 'rapid onset of action of SHR2285 (median time to maximum plasma concentration [T max ', 'Safety, pharmacokinetics, and pharmacodynamics parameters', 'bleeding events', 'serum prothrombin time and international normalized ratio levels', 'Safety, Pharmacokinetics, and Pharmacodynamics', 'FXI activity', 'favorable safety, PK, and PD profiles']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0200482', 'cui_str': 'Prothrombin consumption time'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.144879,"All adverse events were grade 1, and there was no evidence of bleeding events.","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaoduo', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Hu', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, China.'}, {'ForeName': 'Tengfei', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, China.'}, {'ForeName': 'Shuyang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}]",Frontiers in pharmacology,['10.3389/fphar.2022.821363']
2675,35222506,Outcomes Based on Plasma Biomarkers for the Phase 3 CELESTIAL Trial of Cabozantinib versus Placebo in Advanced Hepatocellular Carcinoma.,"Introduction


Cabozantinib, an inhibitor of MET, AXL, and VEGF receptors, significantly improved overall survival (OS) and progression-free survival (PFS) versus placebo in patients with previously treated advanced hepatocellular carcinoma (HCC). In this exploratory analysis, outcomes were evaluated according to plasma biomarker levels.
Methods


Baseline plasma levels were evaluated for MET, AXL, VEGFR2, HGF, GAS6, VEGF-A, PlGF, IL-8, EPO, ANG2, IGF-1, VEGF-C, and c-KIT for 674/707 randomized patients; and Week 4 levels were evaluated for MET, AXL, VEGFR2, HGF, GAS6, VEGF-A, PlGF, IL-8, and EPO for 614 patients. OS and PFS were analyzed by baseline levels as dichotomized or continuous variables and by on-treatment changes at Week 4 as continuous variables; biomarkers were considered potentially prognostic if  p  < 0.05 and predictive if  p  < 0.05 for the interaction between treatment and the biomarker. Multivariable analyses adjusting for clinical covariates were also performed.
Results


In the placebo group, high levels of MET, HGF, GAS6, IL-8, and ANG2 and low levels of IGF-1 were associated with shorter OS in univariate and multivariable analyses; these associations were also observed for MET, IL-8, and ANG2 in the cabozantinib group. Hazard ratios for OS and PFS favored cabozantinib over the placebo at low and high baseline levels for all biomarkers. No baseline biomarkers were predictive of a treatment benefit. Cabozantinib promoted pharmacodynamic changes in several biomarkers, including increases in VEGF-A, PlGF, AXL, and GAS6 levels and decreases in VEGFR2 and HGF levels; these changes were not associated with OS or PFS.
Conclusion


Cabozantinib improved OS and PFS versus placebo at high and low baseline concentrations for all biomarkers analyzed. Low baseline levels of MET, HGF, GAS6, IL-8, and ANG2 and high levels of IGF-1 were identified as potential favorable prognostic biomarkers for survival in previously treated advanced HCC. Although cabozantinib promoted pharmacodynamic changes in several biomarkers, these changes were not associated with survival.",2022,Hazard ratios for OS and PFS favored cabozantinib over the placebo at low and high baseline levels for all biomarkers.,"['patients with previously treated advanced hepatocellular carcinoma (HCC', 'Advanced Hepatocellular Carcinoma']","['Cabozantinib versus Placebo', 'placebo']","['Hazard ratios for OS and PFS', 'overall survival (OS) and progression-free survival (PFS', 'AXL, VEGFR2, HGF, GAS6, VEGF-A, PlGF, IL-8, EPO, ANG2, IGF-1, VEGF-C', 'high levels of MET, HGF, GAS6, IL-8, and ANG2 and low levels of IGF-1', 'VEGFR2 and HGF levels', 'OS and PFS', 'Low baseline levels of MET, HGF, GAS6, IL-8, and ANG2 and high levels of IGF-1', 'VEGF-A, PlGF, AXL, and GAS6 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1259415', 'cui_str': 'AXL protein, human'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C1504871', 'cui_str': 'PGF protein, human'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C3849511', 'cui_str': 'ANGPT2 protein, human'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0388911', 'cui_str': 'Vascular Endothelial Growth Factor-C'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",614.0,0.348156,Hazard ratios for OS and PFS favored cabozantinib over the placebo at low and high baseline levels for all biomarkers.,"[{'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (Milan), Italy.'}, {'ForeName': 'Robin Kate', 'Initials': 'RK', 'LastName': 'Kelley', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Royal Free Hospital and UCL Cancer Institute, London, United Kingdom.'}, {'ForeName': 'Baek-Yeol', 'Initials': 'BY', 'LastName': 'Ryoo', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': 'Groupement Hospitalier Lyon Nord, Lyon, France.'}, {'ForeName': 'Joong-Won', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Blanc', 'Affiliation': 'Hôpital Haut-Lévêque, CHU Bordeaux, Bordeaux, France.'}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': ""Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Yi-Wah', 'Initials': 'YW', 'LastName': 'Chan', 'Affiliation': 'Fios Genomics Ltd, Edinburgh, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McAdam', 'Affiliation': 'Fios Genomics Ltd, Edinburgh, United Kingdom.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Exelixis, Inc., Alameda, California, USA.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'USC Norris Comprehensive Cancer Center, Los Angeles, California, USA.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}]",Liver cancer,['10.1159/000519867']
2676,35222287,Real-Time Flash Glucose Monitoring Had Better Effects on Daily Glycemic Control Compared With Retrospective Flash Glucose Monitoring in Patients With Type 2 Diabetes on Premix Insulin Therapy.,"Background and Aims


To compare the effects of real-time and retrospective flash glucose monitoring (FGM) on daily glycemic control and lifestyle in patients with type 2 diabetes on premix insulin therapy.
Methods and Results


A total of 172 patients using premix insulin, with HbA1c ≥ 7.0% (56 mmol/mol), or the time below the target (TBR) ≥ 4%, or the coefficient of variation (CV) ≥36% during the screening period, were randomly assigned to retrospective FGM (n = 89) or real-time FGM group (n = 83). Another two retrospective or real-time 14-day FGMs were performed respectively, 1 month apart. Both groups received educations and medication adjustment after each FGM. Time in range (3.9~10.0 mmol/l, TIR) increased significantly after 3 months in the real-time FGM group (6.5%) compared with the retrospective FGM group (-1.1%) ( p  = 0.014). HbA1c decreased in both groups (both  p  < 0.01). Real-time FGMs increased daily exercise time compared with the retrospective group ( p  = 0.002).
Conclusions


Real-time FGM with visible blood glucose improves daily glycemic control and diabetes self-care behaviors better than retrospective FGM in patients with type 2 diabetes on premix insulin therapy.
Clinical Trial Registration


https://clinicaltrials.gov/NCT04847219.",2022,"Real-time FGMs increased daily exercise time compared with the retrospective group ( p  = 0.002).
","['patients with type 2 diabetes on premix insulin therapy', 'Patients With Type 2 Diabetes on Premix Insulin Therapy', '172 patients using premix insulin, with HbA1c ≥ 7.0% (56 mmol/mol), or the time below the target (TBR) ≥ 4%, or the coefficient of variation (CV) ≥36% during the screening period']","['retrospective FGM', 'real-time and retrospective flash glucose monitoring (FGM', 'Retrospective Flash Glucose Monitoring', 'visible blood glucose']","['daily glycemic control and diabetes self-care behaviors', 'daily exercise time', 'HbA1c', 'daily glycemic control and lifestyle']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]",172.0,0.0462913,"Real-time FGMs increased daily exercise time compared with the retrospective group ( p  = 0.002).
","[{'ForeName': 'Reng-Na', 'Initials': 'RN', 'LastName': 'Yan', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Cai', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lan-Lan', 'Initials': 'LL', 'LastName': 'Jiang', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Jing', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiao-Jing', 'Initials': 'XJ', 'LastName': 'Xie', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Su', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Department of Endocrinology, Wuxi People's Hospital Affiliated to Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'He', 'Affiliation': 'Department of Endocrinology, Wuxi Hospital of Traditional Chinese Medicine, Wuxi, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': ""Department of Endocrinology, Huai'an Second People's Hospital and the Affiliated Huai'an Hospital of Xuzhou Medical University, Huai'an, China.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': ""Department of Endocrinology, The Affiliated Suqian First People's Hospital of Nanjing Medical University, Suqian, China.""}, {'ForeName': 'Bing-Li', 'Initials': 'BL', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}]",Frontiers in endocrinology,['10.3389/fendo.2022.832102']
2677,35222598,Effect of massage therapy on preterm neonate's body temperature.,"Background


Low-cost care strategies can be implemented to avert the morbidity and mortality associated with hypothermia in preterm neonates.
Objective


To determine the effect of massage therapy on body temperature of preterm neonates.
Methods


A quasi-experimental design was conducted among 72 preterm neonates at a level II special care nursery in Western Kenya. Neonates were recruited on the third day of life and followed up for 10 days. Neonates in the intervention group were massaged three times a day for 15 minutes. Body temperature was monitored and recorded before, during and after each therapy session. Neonates in the control group received routine care: temperature monitoring three times a day, feeding and diaper change.
Results


Neonates who received massage had higher mean body temperature than the control group during therapy on day 6 (p = .019) and after therapy on day 6 (p = .017) and day 8 (p = .005). A comparison within massage group (before/during, during/after, before/after) showed an increase in mean body temperature during therapy compared to before therapy (p <.001) and after therapy compared to before therapy (p <.001).
Conclusion


Massage therapy increases body temperature in preterm neonates.",2021,had higher mean body temperature than the control group during therapy on day 6 (p = .019) and after therapy on day 6 (p = .017) and day 8 (p = .005).,"['preterm neonates', '72 preterm neonates at a level II special care nursery in Western Kenya', ""preterm neonate's body temperature""]","['massage therapy', 'Massage therapy', 'massage', 'routine care: temperature monitoring three times a day, feeding and diaper change']","['Body temperature', 'body temperature', 'mean body temperature']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0441926', 'cui_str': 'Level II'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0180416', 'cui_str': 'Diaper'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",72.0,0.0298827,had higher mean body temperature than the control group during therapy on day 6 (p = .019) and after therapy on day 6 (p = .017) and day 8 (p = .005).,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Nyaga', 'Affiliation': 'School of Nursing, Moi University.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Esamai', 'Affiliation': 'School of Medicine, Moi University.'}, {'ForeName': ""O'Brien"", 'Initials': 'O', 'LastName': 'Kyololo', 'Affiliation': 'School of Nursing, Moi University.'}]",African health sciences,['10.4314/ahs.v21i3.44']
2678,35222592,Effect of different cold application materials on pain during chest tube removal: three-arm randomized controlled clinical trial.,"Background


Chest tube causes severe pain during removal because it attaches to the endothelium in the chest cavity.
Objectives


This study aimed to determine the effectiveness of cold application with ice pack and gel pad in the control of pain experienced during chest tube removal.
Methods


The sample of prospective, parallel three-arm (1:1:1), randomized controlled clinical trial consisted of 180 patients in two experimental groups (ice pack/gel pad) and one control group. The primary outcome was effect of cold application materials on severity of pain during chest removal. Secondary outcomes were duration of cold application and analgesic requirements of the patients.
Results


The study found that the cold application using either of the materials reduced the severity of pain and the need for analgesics after the removal of chest tube compared to the control group (p<0.05). But cold application with ice pack allowed the skin to drop to the temperature effective in pain control in a shorter time than gel pad application (p<0.05).
Conclusions


Despite entirely covering the area around the chest tube, the gel pad was more disadvantageous than ice pack in pain control due to the longer duration of cold application.",2021,The study found that the cold application using either of the materials reduced the severity of pain and the need for analgesics after the removal of chest tube compared to the control group (p<0.05).,"['180 patients in two experimental groups (ice pack/gel pad) and one control group', 'pain during chest tube removal']","['cold application materials', 'cold application with ice pack and gel pad']","['severity of pain during chest removal', 'severity of pain', 'duration of cold application and analgesic requirements of the patients']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0181264', 'cui_str': 'Ice bag'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2224175', 'cui_str': 'Chest tube removal'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0181264', 'cui_str': 'Ice bag'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332568', 'cui_str': 'Pad'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",180.0,0.0496696,The study found that the cold application using either of the materials reduced the severity of pain and the need for analgesics after the removal of chest tube compared to the control group (p<0.05).,"[{'ForeName': 'Dilara', 'Initials': 'D', 'LastName': 'Soydan', 'Affiliation': 'Mersin University, Turkey.'}, {'ForeName': 'Gülay Altun', 'Initials': 'GA', 'LastName': 'Uğraş', 'Affiliation': 'Mersin University, Turkey.'}]",African health sciences,['10.4314/ahs.v21i3.38']
2679,35222585,Inflammatory cytokines and sleep parameters response to life style intervention in subjects with obese chronic insomnia syndrome.,"Background


Chronic primary insomnia is a prevalent sleep disorder that is associated with adverse effects on health outcomes. Sleep disturbance is usually associated with abnormal level of systemic inflammation biomarkers.
Objective


The aim of this study was to detect changes in sleep quality and inflammatory markers following weight loss among subjects with chronic primary insomnia.
Material and methods


Eighty previously sedentary subjects with chronic primary insomnia subjects enrolled in this study, their age ranged from 32-51 year were randomly assigned to life style intervention group (group A, n=40) or control group (group B, n=40). Polysomnographic recordings for sleep quality assessment, IL-6, IL-10 and TNF-α were measured before and at the end of the study after six months.
Results


There was a significant increase in the total sleep duration, sleep efficiency, sleep onset latency and IL-10 in addition to significant reduction in awake time after sleep onset, REM latency, IL-6 and TNF-α after 6 months of in group(A) as a result of weight loss program; while the results of the control group (group B) were not significant. Also, there were significant differences between both groups at the end of the study.
Conclusion


Life style intervention modulates systemic inflammatory parameters and sleep quality among subjects with chronic primary insomnia.",2021,"There was a significant increase in the total sleep duration, sleep efficiency, sleep onset latency and IL-10 in addition to significant reduction in awake time after sleep onset, REM latency, IL-6 and TNF-α after 6 months of in group(A) as a result of weight loss program; while the results of the control group (group B) were not significant.","['Eighty previously sedentary subjects with chronic primary insomnia subjects enrolled in this study, their age ranged from 32-51 year', 'subjects with obese chronic insomnia syndrome', 'subjects with chronic primary insomnia']","['life style intervention group', 'Life style intervention', 'control group', 'life style intervention']","['sleep quality', 'sleep quality assessment, IL-6, IL-10 and TNF-α', 'total sleep duration, sleep efficiency, sleep onset latency and IL-10', 'sleep quality and inflammatory markers', 'awake time after sleep onset, REM latency, IL-6 and TNF-α', 'weight loss program', 'Sleep disturbance']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]",80.0,0.0680853,"There was a significant increase in the total sleep duration, sleep efficiency, sleep onset latency and IL-10 in addition to significant reduction in awake time after sleep onset, REM latency, IL-6 and TNF-α after 6 months of in group(A) as a result of weight loss program; while the results of the control group (group B) were not significant.","[{'ForeName': 'Fadwah M', 'Initials': 'FM', 'LastName': 'Al-Sharif', 'Affiliation': 'Department of Medical Laboratory Technology, Faculty of Applied Medical Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Shehab M Abd', 'Initials': 'SMA', 'LastName': 'El-Kader', 'Affiliation': 'Department of Physical Therapy, Faculty of Applied Medical Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.'}]",African health sciences,['10.4314/ahs.v21i3.31']
2680,35222584,Aerobic versus resistance exercises on systemic inflammation and sleep parameters in obese subjects with chronic insomnia syndrome.,"Background


Chronic primary insomnia is a prevalent sleep disorder that is associated with adverse effects on health outcomes. Exercise is often considered a non-pharmacological approach that could have beneficial effects on sleep.
Objective


The aim of the study was to compare the impact of aerobic and resistance exercise training on quality of sleep and inflammatory markers among subjects with chronic primary insomnia.
Material and methods


Sixty previously sedentary subjects with chronic primary insomnia subjects enrolled in this study, their age ranged from 31-52 years. All participants were randomly assigned to aerobic exercise intervention group (group A, n=35) or resistance exercise intervention group (group B, n=35). Polysomnographic recordings for sleep quality assessment, IL-6, IL-10 and TNF-α were measured before and at the end of the study after six months.
Results


There was a significant increase in the total sleep duration, sleep efficiency, sleep onset latency and IL-10 in group(A) and group (B) in addition to significant reduction in awake time after sleep onset, REM latency, IL-6 and TNF-α after 6 months of aerbic and resistance exercise training. However, there were significant differences between both groups at the end of the study.
Conclusion


Aerobic exercise training is more appropriately than resistance exercise training in modulation of inflammatory and sleep quality among subjects with chronic primary insomnia.",2021,"There was a significant increase in the total sleep duration, sleep efficiency, sleep onset latency and IL-10 in group(A) and group (B) in addition to significant reduction in awake time after sleep onset, REM latency, IL-6 and TNF-α after 6 months of aerbic and resistance exercise training.","['obese subjects with chronic insomnia syndrome', 'Sixty previously sedentary subjects with chronic primary insomnia subjects enrolled in this study, their age ranged from 31-52 years', 'subjects with chronic primary insomnia']","['resistance exercise training', 'Aerobic versus resistance exercises', 'resistance exercise intervention group', 'aerobic exercise intervention', 'aerobic and resistance exercise training', 'Aerobic exercise training']","['systemic inflammation and sleep parameters', 'sleep quality assessment, IL-6, IL-10 and TNF-α', 'inflammatory and sleep quality', 'awake time after sleep onset, REM latency, IL-6 and TNF-α', 'total sleep duration, sleep efficiency, sleep onset latency and IL-10 in group(A', 'quality of sleep and inflammatory markers']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",60.0,0.035091,"There was a significant increase in the total sleep duration, sleep efficiency, sleep onset latency and IL-10 in group(A) and group (B) in addition to significant reduction in awake time after sleep onset, REM latency, IL-6 and TNF-α after 6 months of aerbic and resistance exercise training.","[{'ForeName': 'Osama H', 'Initials': 'OH', 'LastName': 'Al-Jiffri', 'Affiliation': 'Department of Medical Laboratory Technology, Faculty of Applied Medical Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Shehab M', 'Initials': 'SM', 'LastName': 'Abd El-Kader', 'Affiliation': 'Department of Physical Therapy, Faculty of Applied Medical Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.'}]",African health sciences,['10.4314/ahs.v21i3.30']
2681,35222547,Survival Nomogram for Metastasis Colon Cancer Patients Based on SEER Database.,"Introduction:  A prediction model for the 1-, 3-, and 5-year survival rates of metastatic colon cancer (mCC) patients was developed by analyzing important risk factors for the prognosis of mCC patients based on the SEER database.  Method:  The characteristic of 10,946 patients diagnosed with mCC between 2010 and 2015 was obtained from the SEER database. The population was randomly divided into a training cohort and an internal validation cohort in a 7:3 ratio. Univariate and multivariate cox for independent predictors of mCC prognosis were performed, and nomogram was constructed. The accuracy of the model was verified by calibration curves, ROC curves, and C-index, and the clinical utility of the model was analyzed using decision analysis curves.  Result:  Age, primary site, grade, surgery, and other eight factors were significantly associated with the prognosis of mCC patients, and these predictors were included in the construction of the nomogram. The C-index was 0.731 (95% CI 0.725-0.737) and 0.736 (95% CI 0.726-0.746) for the training cohort and the validation set, respectively. The results of the ROC curve analysis indicated that the area under the curve (AUC) exceeded 0.7 for both the training cohort and the validation set at 1, 3, and 5 years.  Conclusion:  The constructed prediction model had an excellent predictive accuracy, which will help clinical decision-making of mCC patients after surgery and individualized treatment.",2022,"The accuracy of the model was verified by calibration curves, ROC curves, and C-index, and the clinical utility of the model was analyzed using decision analysis curves.  ","['Metastasis Colon Cancer Patients Based on SEER Database', 'metastatic colon cancer (mCC) patients', '10,946 patients diagnosed with mCC between 2010 and 2015 was obtained from the SEER database']",[],"['5-year survival rates', 'Survival Nomogram']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242638', 'cui_str': 'Surveillance, Epidemiology, and End Results Program'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0278484', 'cui_str': 'Colon cancer stage IV'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007129', 'cui_str': 'Merkel cell carcinoma'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1450294', 'cui_str': 'Nomogram chart'}]",10946.0,0.0583298,"The accuracy of the model was verified by calibration curves, ROC curves, and C-index, and the clinical utility of the model was analyzed using decision analysis curves.  ","[{'ForeName': 'Qinwen', 'Initials': 'Q', 'LastName': 'Tai', 'Affiliation': 'Department of General Surgery, Shenzhen Hospital, Southern Medical University, Shenzhen, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Department of Pharmacy, Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning, China.'}, {'ForeName': 'Mengying', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'The First College of Clinical Science, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Zhuo', 'Affiliation': 'Medical College of Shaoguan University, Shaoguan, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, Shenzhen Hospital, Southern Medical University, Shenzhen, China.'}, {'ForeName': 'Fa', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'Department of General Surgery, Shenzhen Hospital, Southern Medical University, Shenzhen, China.'}, {'ForeName': 'Jinhui', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, Shenzhen Hospital, Southern Medical University, Shenzhen, China.'}]",Frontiers in genetics,['10.3389/fgene.2022.832060']
2682,35222899,Observation on the Rehabilitation Effect of Athletes with Anterior Cruciate Ligament Injury of the Knee Based on Multidisciplinary Combined Nondrug Therapy.,"This study analyzes the rehabilitation effects of athletes with anterior cruciate ligament injury of the knee based on multidisciplinary combined nondrug therapy. For this purpose, 70 athletes with anterior cruciate ligament injury of the knee admitted from September 2019 to December 2020, who were randomly selected, were the subjects of the study. According to the random number table method, they were divided into the control group and observation group, with 35 cases in each group. The control group was given conventional conservative treatment such as braces braking, local physiotherapy, and routine rehabilitation exercise after injury. For the observation group, multidisciplinary combined nondrug therapy was implemented on the basis of the control group. After receiving the intervention, the balance function score of the observation group was significantly higher than that of the control group, and the difference between the two groups was statistically significant ( P  < 0.05). After receiving the intervention, the functional recovery scores of the knee joint of the observation group were significantly higher than that of the control group, and the difference between the two groups was statistically significant ( P  < 0.05). Before treatment, there was no significant difference in knee flexion extension, internal rotation, and external rotation between the two groups ( P  > 0.05). After treatment, flexion extension, internal rotation, and external rotation of the knee joint in the observation group were significantly higher than those in the control group ( P  < 0.05). There was no significant difference in VAS scores between the two groups before treatment ( P  > 0.05). After treatment, the VAS score of the observation group was significantly lower than that of the control group ( P  < 0.05). Multidisciplinary combined nondrug therapy has a good therapeutic effect in the treatment of anterior cruciate ligament injury of the knee for athletes. It can be used as a conservative treatment method to improve the score of balance function and recovery of lacquer joint function, enhance the range of motion of the knee joint, and reduce the VAS.",2022,"Before treatment, there was no significant difference in knee flexion extension, internal rotation, and external rotation between the two groups ( P  > 0.05).","['Athletes with Anterior Cruciate Ligament Injury of the Knee Based on Multidisciplinary Combined Nondrug Therapy', '70 athletes with anterior cruciate ligament injury of the knee admitted from September 2019 to December 2020, who were randomly selected, were the subjects of the study', 'athletes with anterior cruciate ligament injury of the knee based on', 'anterior cruciate ligament injury of the knee for athletes']","['conventional conservative treatment such as braces braking, local physiotherapy, and routine rehabilitation exercise', 'Multidisciplinary combined nondrug therapy', 'multidisciplinary combined nondrug therapy']","['knee flexion extension, internal rotation, and external rotation', 'VAS score', 'balance function score', 'flexion extension, internal rotation, and external rotation of the knee joint', 'VAS scores', 'functional recovery scores of the knee joint']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}]",70.0,0.00979022,"Before treatment, there was no significant difference in knee flexion extension, internal rotation, and external rotation between the two groups ( P  > 0.05).","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'School of Physical Education, Yangzhou University, Yangzhou, China.'}]",Journal of healthcare engineering,['10.1155/2022/9528354']
2683,35222898,"The Difference between Sacubitril Valsartan and Valsartan on Vascular Endothelial Function, APN, MMP-9, and BNP Levels in Patients with Hypertension and Chronic Heart Failure.","Background


Sacubitril valsartan and valsartan are the first new drugs approved for angiotensin receptor neprilysin lysine inhibitors (ARNIs) in outpatients with chronic heart failure (CHF) and hypertension. Compared with enalapril, sacubitril valsartan and valsartan have been shown to reduce the mortality and morbidity of cardiovascular diseases. However, there is little actual evidence regarding the efficacy of ARNIs in hypertensive patients with CHF.
Methods


From January 2019 to January 2021, 60 patients with hypertension and chronic heart failure were diagnosed and treated in our hospital. The patients were randomly divided into an observation group and a control group, with 30 cases in each group. The control group was given valsartan, the observation group was given sacubitril valsartan, and both groups were treated for six months. The endothelium-dependent vasodilation (EDD) function of the brachial artery and serum nitric oxide (NO), endothelin-1 (ET-1), carotid artery intima-media thickness, and glomerular filtration, excess rate (eGFR), and left ventricular ejection fraction (LVEF) were compared between the two groups of patients before and after treatment. The serum adiponectin (APN), matrix metalloproteinase-9 (MMP-9), and brain natriuretic peptide (BNP) levels were compared before and after treatment.
Results


The total effective rate of treatment in the research group was higher than that in the control group ( P  < 0.05). After treatment, the cardiac function indexes LVESD and LVEDD of the two groups of patients were lower than before treatment, and LVEF was higher than before treatment, and the improvement rate of the treatment group was better than that of the control group ( P  < 0.05). After treatment, the serum APN of the two groups was higher than before treatment, the levels of MMP-9 and BNP were lower than before treatment, and the improvement rate of patients in the treatment group was better than that of patients in the control group ( P  < 0.05). There was no statistically significant in the levels of EDD, NO, and ET-1 of the two groups of patients before treatment ( P  < 0.05). After treatment, compared with the control group, the EDD function and NO level of the research group were significantly increased ( P  < 0.05), and the level of ET-1 was significantly reduced ( P  < 0.05). There was no statistically significant difference in carotid artery intima-media thickness, glomerular filtration rate, and left ventricular ejection fraction before and after treatment in the two groups ( P  < 0.05).
Conclusion


In the treatment of hypertension and chronic heart failure, sacubitril valsartan can improve the clinical symptoms of patients to the greatest extent and can significantly improve the levels of LVEF, LVEDD, NT-proBNP, heart function, and other indicators. Sacubitril valsartan can increase serum APN levels, reduce MMP-9 and BNP levels, and have good clinical effects. Sacubitril valsartan has a protective effect on the vascular endothelial function of patients with hypertension and CHF. However, these results need to be confirmed in studies involving more subjects and require longer follow-up times.",2022,"There was no statistically significant difference in carotid artery intima-media thickness, glomerular filtration rate, and left ventricular ejection fraction before and after treatment in the two groups ( P  < 0.05).
","['outpatients with chronic heart failure (CHF) and hypertension', 'Patients with Hypertension and Chronic Heart Failure', 'hypertensive patients with CHF', 'patients with hypertension and CHF', 'From January 2019 to January 2021, 60 patients with hypertension and chronic heart failure were diagnosed and treated in our hospital']","['Sacubitril valsartan', 'Sacubitril Valsartan and Valsartan', '\n\n\nSacubitril valsartan and valsartan', 'valsartan, the observation group was given sacubitril valsartan', 'enalapril, sacubitril valsartan and valsartan']","['level of ET-1', 'serum APN levels, reduce MMP-9 and BNP levels', 'total effective rate', 'levels of EDD, NO, and ET-1', 'levels of LVEF, LVEDD, NT-proBNP, heart function', 'cardiac function indexes LVESD and LVEDD', 'mortality and morbidity of cardiovascular diseases', 'serum APN', 'EDD function and NO level', 'vascular endothelial function', 'LVEF', 'Vascular Endothelial Function, APN, MMP-9, and BNP Levels', 'endothelium-dependent vasodilation (EDD) function of the brachial artery and serum nitric oxide (NO), endothelin-1 (ET-1), carotid artery intima-media thickness, and glomerular filtration, excess rate (eGFR), and left ventricular ejection fraction (LVEF', 'serum adiponectin (APN), matrix metalloproteinase-9 (MMP-9), and brain natriuretic peptide (BNP) levels', 'improvement rate', 'levels of MMP-9 and BNP', 'carotid artery intima-media thickness, glomerular filtration rate, and left ventricular ejection fraction']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",60.0,0.00979038,"There was no statistically significant difference in carotid artery intima-media thickness, glomerular filtration rate, and left ventricular ejection fraction before and after treatment in the two groups ( P  < 0.05).
","[{'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Department of Cardiology (I), East Hospital, Yantaishan Hospital, Yantai 264000, Shandong, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology (II), The Third People's Hospital of Qingdao, Qingdao University, Qingdao 266041, Shandong, China.""}, {'ForeName': 'Weifang', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Cardiac Function Examination Room, Affiliated Qingdao Central Hospital, Qingdao University, Qingdao 266042, Shandong, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': 'Department of Hypertension, Jinan Municipal Hospital of Traditional Chinese Medicine, Jinan 250012, Shandong, China.'}]",Journal of healthcare engineering,['10.1155/2022/9494981']
2684,35222895,Effect of Whole-Course Continuous Nursing Intervention Combined with a Nursing Practice Teaching Method on Quality of Life of Children with Functional Dyspepsia and Parents' Satisfaction Based on Smart Health.,"With the development of information technology, it has become a part of people's lives. WeChat is not only a popular chatting tool in daily life but can also be used in the medical field. Functional dyspepsia is a common pediatric disease, with complex pathogenic factors, which are usually attributed to abnormal gastric acid secretion and gastrointestinal dysfunction. In our research, we aim to investigate the effects of whole-course continuous nursing intervention combined with a nursing practice teaching method on the quality of life (QOL) of children with functional dyspepsia and parents' satisfaction. One hundred and twenty children with functional dyspepsia admitted to our hospital (February 2019-February 2020) were retrospectively analyzed and equally divided into the experimental group (EG) and the control group (CG) according to the order of admission. The CG received whole-course continuous nursing intervention, and the EG received whole-course continuous nursing intervention combined with the nursing practice teaching method. Children's psychological states and QOL and parents' satisfaction of both groups were compared. After discharge, compared with the CG, the negative emotion scores in the EG were remarkably lower ( P  < 0.001). After discharge, compared with the CG, the QOL scores ( P  < 0.001), the proportion of children with good and excellent QOL ( P  < 0.05), and parents' satisfaction ( P  < 0.001) in the EG were remarkably higher. For children with functional dyspepsia, whole-course continuous nursing intervention combined with the nursing practice teaching method can improve their negative emotions, QOL, and parents' satisfaction, which should be popularized in practice.",2022,"After discharge, compared with the CG, the QOL scores ( P  < 0.001), the proportion of children with good and excellent QOL ( P  < 0.05), and parents' satisfaction ( P  < 0.001) in the EG were remarkably higher.","['children with functional dyspepsia', ""children with functional dyspepsia and parents' satisfaction"", 'One hundred and twenty children with functional dyspepsia admitted to our hospital (February 2019-February 2020', ""Children with Functional Dyspepsia and Parents' Satisfaction Based on Smart Health""]",['control group (CG'],"['negative emotion scores', 'proportion of children with good and excellent QOL', ""parents' satisfaction"", ""negative emotions, QOL, and parents' satisfaction"", 'QOL scores', 'Quality of Life', ""Children's psychological states and QOL and parents' satisfaction"", 'quality of life (QOL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}]",120.0,0.0113343,"After discharge, compared with the CG, the QOL scores ( P  < 0.001), the proportion of children with good and excellent QOL ( P  < 0.05), and parents' satisfaction ( P  < 0.001) in the EG were remarkably higher.","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Pediatric Internal Medicine Nursing Unit, The First People's Hospital of Lianyungang, The First Affiliated Hospital of Kangda College of Nanjing Medical University (The First People's Hospital of Lianyungang), Lianyungang 222000, Jiangsu, China.""}, {'ForeName': 'Fenqin', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Nursing Department, The First People's Hospital of Lianyungang, The First Affiliated Hospital of Kangda College of Nanjing Medical University (The First People's Hospital of Lianyungang), Lianyungang 222000, Jiangsu, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Department of Pediatrics, The First People's Hospital of Lianyungang, Lianyungang 222000, Jiangsu, China.""}, {'ForeName': 'Kangwei', 'Initials': 'K', 'LastName': 'Mao', 'Affiliation': ""Department of Pediatrics, The First People's Hospital of Lianyungang, Lianyungang 222000, Jiangsu, China.""}, {'ForeName': 'Suyun', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': ""Pediatric Internal Medicine Nursing Unit, The First People's Hospital of Lianyungang, The First Affiliated Hospital of Kangda College of Nanjing Medical University (The First People's Hospital of Lianyungang), Lianyungang 222000, Jiangsu, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Dai', 'Affiliation': ""Nursing Unit of Department of Neonatology, The First People's Hospital of Lianyungang, The First Affiliated Hospital of Kangda College of Nanjing Medical University (The First People's Hospital of Lianyungang, Lianyungang 222000, Jiangsu, China.""}]",Journal of healthcare engineering,['10.1155/2022/8638564']
2685,35222890,Efficacy of Intramedullary Nailing in the Treatment of Comminuted Proximal Humeral Fractures and Its Influence on Shoulder Joint Function Recovery.,"In this paper, we have aimed to elucidate the therapeutic effect of intramedullary nailing (IMN) in treating comminuted proximal humeral fractures (CPHFs) and its influence on the recovery of shoulder joint function. For this purpose, 60 cases with CPHFs were selected, particularly from January 2020 to October 2021. In these cases, 28 cases were treated with a locking proximal humeral plate (LPHP) and assigned to the control (Con) group and the remaining 32 patients were treated with IMN and included in the research (Res) group. The therapeutic effect, surgical indicators, total complications, visual analogue scale (VAS) score, and postoperative shoulder joint function score were compared between the two arms. We observed that compared with the Con group, the effective rate in the Res group was higher while the operation time, intraoperative blood loss, and fracture healing time were shorter, the overall complication rate and VAS score were lower, and the postoperative shoulder joint function score was higher, all with statistical significance. The above results indicate that IMN is effective and safe in the treatment of CPHFs, which can validly reduce the discomfort of patients and facilitate the recovery of shoulder joint function.",2022,"We observed that compared with the Con group, the effective rate in the Res group was higher while the operation time, intraoperative blood loss, and fracture healing time were shorter, the overall complication rate and VAS score were lower, and the postoperative shoulder joint function score was higher, all with statistical significance.","['60 cases with CPHFs were selected, particularly from January 2020 to October 2021']","['locking proximal humeral plate (LPHP', 'Intramedullary Nailing', 'intramedullary nailing (IMN', 'IMN']","['therapeutic effect, surgical indicators, total complications, visual analogue scale (VAS) score, and postoperative shoulder joint function score', 'operation time, intraoperative blood loss, and fracture healing time', 'Shoulder Joint Function Recovery', 'effective rate', 'postoperative shoulder joint function score', 'overall complication rate and VAS score']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0037006', 'cui_str': 'Fracture of shoulder'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",60.0,0.00962314,"We observed that compared with the Con group, the effective rate in the Res group was higher while the operation time, intraoperative blood loss, and fracture healing time were shorter, the overall complication rate and VAS score were lower, and the postoperative shoulder joint function score was higher, all with statistical significance.","[{'ForeName': 'Weibin', 'Initials': 'W', 'LastName': 'Lan', 'Affiliation': 'Department of Orthopedics, Longyan First Affiliated Hospital of Fujian Medical University, Longyan 364000, Fujian, China.'}, {'ForeName': 'Feibin', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Orthopedic Trauma, Xiamen University Zhongshan Hospital, Xiamen 361004, Fujian, China.'}, {'ForeName': 'Wutang', 'Initials': 'W', 'LastName': 'Que', 'Affiliation': 'Department of Orthopedics, Longyan First Affiliated Hospital of Fujian Medical University, Longyan 364000, Fujian, China.'}, {'ForeName': 'Xuezhao', 'Initials': 'X', 'LastName': 'Tu', 'Affiliation': 'Department of Orthopedics, Longyan First Affiliated Hospital of Fujian Medical University, Longyan 364000, Fujian, China.'}, {'ForeName': 'Xiaomeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Longyan First Affiliated Hospital of Fujian Medical University, Longyan 364000, Fujian, China.'}]",Journal of healthcare engineering,['10.1155/2022/7272385']
2686,35223108,Planned percutaneous nephrolithotomy in patients who initially presented with urosepsis: Analysis of outcomes and complications.,"Objective


To compare the outcomes and complications of planned percutaneous nephrolithotomy (PCNL) in patients with a prior urosepsis episode to those without.
Patients and Methods


We recorded patients who presented initially with obstructive urosepsis, as identified by systemic inflammatory response syndrome and obstructing kidney stones. We compared the surgical outcomes and complications among those patients who had planned PCNL after control of prior urosepsis with urgent decompression and antibiotics (Group A) to a group who presented for PCNL with no previous history of a septic presentations (Group B). A 1:1 matched-pair analysis was performed using four parameters (age, gender, body mass index, and American Society of Anesthesiologists classification) to eliminate potential allocation bias. Primary outcomes included were stone-free rate (SFR) and complication rate. Secondary outcomes included were operative time, estimated blood loss, and duration of postoperative hospital stay.
Results


A total of 80 patients underwent PCNL (48 male and 32 females) divided equally between both treatment groups, with a mean (interquartile range) age of 47 (19-75) years. There were no differences in demographic data or stone characteristics between both groups. Both groups had comparable SFRs (92.5% vs 97.5%,  P  = 0.212) and mean operative time (77 vs 74 min,  P  = 0.728) (Table 2). Patients in Group A had a significantly higher overall complications rate (35% vs 10%,  P  = 0.03) . There were no postoperative mortalities and the mean length of hospital stay was significantly longer in Group A patients compared to group B (4.2 vs 1.5 days,  P  = 0.042).
Conclusions


: Planned PCNL after decompression for urolithiasis-related sepsis has comparable operative time and SFR but higher complication rates and longer postoperative hospital stay. This is critical in counselling patients prior to definitive treatment of kidney stones after urgent decompression for urosepsis and for adequate preoperative planning and preparation. Abbreviations:  ASA: American Society of Anesthesiologists; BMI: body mass index; ICU: intensive care unit; IQR: interquartile range; KUB: plain abdominal radiograph of the kidneys, ureters and bladder; PCN: percutaneous nephrostomy; PCNL: percutaneous nephrolithotomy; SFR: stone-free rate; URS; ureteroscopy; US: ultrasonography.",2022,Planned PCNL after decompression for urolithiasis-related sepsis has comparable operative time and SFR but higher complication rates and longer postoperative hospital stay.,"['patients who presented initially with obstructive urosepsis, as identified by systemic inflammatory response syndrome and obstructing kidney stones', 'patients with a prior urosepsis episode to those without', 'counselling patients prior to definitive treatment of kidney stones after urgent decompression for urosepsis and for adequate preoperative planning and preparation', 'patients who had planned PCNL after control of prior urosepsis with urgent decompression and antibiotics (Group A) to a group who presented for PCNL with no previous history of a septic presentations (Group B', 'patients who initially presented with urosepsis', '80 patients underwent PCNL (48 male and 32 females) divided equally between both treatment groups, with a mean (interquartile range) age of 47 (19-75) years']","['Planned percutaneous nephrolithotomy', 'planned percutaneous nephrolithotomy (PCNL']","['mean length of hospital stay', 'postoperative mortalities', 'stone-free rate (SFR) and complication rate', 'demographic data or stone characteristics', 'operative time, estimated blood loss, and duration of postoperative hospital stay', 'mean operative time', 'SFRs', 'overall complications rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0149801', 'cui_str': 'Sepsis due to urinary tract infection'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0549186', 'cui_str': 'Obstructed'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0332315', 'cui_str': 'Has plan'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",80.0,0.0496646,Planned PCNL after decompression for urolithiasis-related sepsis has comparable operative time and SFR but higher complication rates and longer postoperative hospital stay.,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Fahmy', 'Affiliation': 'Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Saad', 'Affiliation': 'Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Sameh', 'Affiliation': 'Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Elgebaly', 'Affiliation': 'Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}]",Arab journal of urology,['10.1080/2090598X.2021.2002635']
2687,35223107,The effect of stone size on the results of extracorporeal shockwave lithotripsy versus semi-rigid ureteroscopic lithotripsy in the management of upper ureteric stones.,"Objectives


To evaluate the role of stone size on the efficacy and safety of extracorporeal shockwave lithotripsy (ESWL) monotherapy vs ureteroscopy (URS) for managing upper ureteric stones.
Patients and methods


The study design was a randomised prospective study of a total cohort of 180 patients with upper ureteric single stones of 0.5-1.5 cm. Half of the patients were managed by ESWL monotherapy, while the other half underwent URS with stone fragmentation using an ultrasound lithotripter (URSL). The success rate, re-treatment rate, auxiliary procedure (AP) rate, efficacy quotient, and complications were compared between the two groups.
Results


After single URSL and ESWL procedures 70/90 (77.8%) and 35/90 (38.9%) of the stones were successfully cleared, respectively ( P  < 0.001). The re-treatment rate after ESWL was significantly higher than in the URSL group (38.9% vs 11.1%,  P  < 0.001). Requiring an AP was not significantly different following ESWL (22.2%) and URSL (24.4%) treatment. The overall stone-free rate (SFR) at 3 months was significantly superior in the URSL group (88.9% vs 77.8%); however, both procedures had excellent results with no significant difference for stones of <1 cm (95.5% vs 92.9%,  P  > 0.05), compared to better results following URSL for stones of >1 cm (82.6% vs 64.6%,  P  < 0.05).
Conclusion


Our present study supports that ESWL is recommended as a first-line non-invasive monotherapy for upper ureteric opaque stones of <1 cm, while URSL is recommended as a first-line treatment for stones of >1 cm. The results for URSL were superior with lower a re-treatment rate, rapid stone clearance in a very short time, and less radiation exposure. Therefore, stone size is an important factor for the final decision of the initial management of upper ureteric stones because it has a direct relation to the efficacy of ESWL, but it has no effect on the results of URSL.",2022,"The results for URSL were superior with lower a re-treatment rate, rapid stone clearance in a very short time, and less radiation exposure.","['upper ureteric stones', '180 patients with upper ureteric single stones of 0.5-1.5 cm']","['ESWL', 'extracorporeal shockwave lithotripsy (ESWL) monotherapy vs ureteroscopy (URS', 'URS with stone fragmentation using an ultrasound lithotripter (URSL', 'extracorporeal shockwave lithotripsy versus semi-rigid ureteroscopic lithotripsy', 'URSL']","['efficacy and safety', 'overall stone-free rate (SFR', 'success rate, re-treatment rate, auxiliary procedure (AP) rate, efficacy quotient, and complications']","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181670', 'cui_str': 'Lithotripter'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",180.0,0.0572261,"The results for URSL were superior with lower a re-treatment rate, rapid stone clearance in a very short time, and less radiation exposure.","[{'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'El-Abd', 'Affiliation': 'Urology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Tawfeek', 'Affiliation': 'Urology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Shawky A', 'Initials': 'SA', 'LastName': 'El-Abd', 'Affiliation': 'Urology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Tarik A', 'Initials': 'TA', 'LastName': 'Gameel', 'Affiliation': 'Urology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Hasan H', 'Initials': 'HH', 'LastName': 'El-Tatawy', 'Affiliation': 'Urology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Magdy A', 'Initials': 'MA', 'LastName': 'El-Sabaa', 'Affiliation': 'Urology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed G', 'Initials': 'MG', 'LastName': 'Soliman', 'Affiliation': 'Urology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Arab journal of urology,['10.1080/2090598X.2021.1996820']
2688,35223106,Can high-dose tranexamic acid have a role during transurethral resection of the prostate in large prostates? A randomised controlled trial.,"Objectives


To assess the efficacy and safety of high-dose tranexamic acid (TXA) during bipolar transurethral resection of the prostate (B-TURP) in patients with large prostates compared to placebo.
Patients and methods


From February 2018 to May 2020, 204 patients with enlarged prostates of 80-130 g and in need of surgical intervention were randomised into two groups. Patients in Group A underwent B-TURP and received TXA as an intravenous loading dose of 50 mg/kg over 20 min before induction of anaesthesia followed by a maintenance infusion of 5 mg/kg/h until resection was completed. The patients in Group B (placebo) received a saline infusion of a similar volume.
Results


There was highly significant drop in haemoglobin in the placebo group at 4- and 24-h postoperatively compared with the TXA group ( P  < 0.001). However, there was no significant difference in the blood transfusion rate between the two groups with five patients (5.5%) in the placebo group and four (4.2%) in the TXA group requiring a transfusion ( P  = 0.74). The procedural time was significantly less in the TXA group vs the control group, at a mean (SD) of 79.93 (22.18) vs 90.91 (21.4) min ( P  = 0.001). Also, the intraoperative irrigation fluid volume and postoperative irrigation duration were significantly less in the TXA group vs the control group, at a mean (SD) of 19.21 (3.13) vs 23.05 (3.8) L and 14.75 (5.15) vs 18.33 (5.96) h, respectively ( P  = 0.001). Catheterisation and hospital stay durations were comparable between both groups ( P  = 0.384 and  P  = 0.388, respectively). No complications were recorded with use of high-dose TXA.
Conclusion


High-dose TXA was effective in controlling blood loss during B-TURP in patients with large prostates, with no adverse drug reactions.",2022,There was highly significant drop in haemoglobin in the placebo group at 4- and 24-h postoperatively compared with the TXA group ( P  < 0.001).,"['Patients and methods\n\n\nFrom February 2018 to May 2020, 204 patients with enlarged prostates of 80-130\xa0g and in need of surgical intervention', 'patients with large prostates']","['tranexamic acid', 'placebo', 'saline infusion of a similar volume', 'Group B (placebo', 'high-dose tranexamic acid (TXA', 'TXA']","['blood loss', 'blood transfusion rate', 'procedural time', 'Catheterisation and hospital stay durations', 'haemoglobin', 'efficacy and safety', 'intraoperative irrigation fluid volume and postoperative irrigation duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0426732', 'cui_str': 'Large prostate'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]",204.0,0.200854,There was highly significant drop in haemoglobin in the placebo group at 4- and 24-h postoperatively compared with the TXA group ( P  < 0.001).,"[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Samir', 'Affiliation': 'Department of Urology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Saafan', 'Affiliation': 'Department of Urology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Rania M', 'Initials': 'RM', 'LastName': 'Afifi', 'Affiliation': 'Department of Urology, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Tawfick', 'Affiliation': 'Department of Urology, Ain Shams University, Cairo, Egypt.'}]",Arab journal of urology,['10.1080/2090598X.2021.1932125']
2689,35223096,Effectiveness of Positive Psychotherapy on Depression and Alexithymia in Women Applying for a Divorce.,"Background


The new therapeutic approach of positive psychotherapy has successfully treated severe mental disorders such as depression and mood disorders. However, existing research has not sufficiently measured the usefulness of this treatment in reducing depression and alexithymia.
Objectives


This study thus examined the effectiveness of positive psychotherapy in reducing these two conditions in a specific population: Iranian women applying for the divorce.
Methods


A total of 40 participants aged 20-40 with a high score in the Beck Depression Inventory and Toronto Alexithymia Questionnaire were recruited from women referred to a psychology clinic for divorce-related problems. The pretest, posttest, and follow-up were conducted with all participants, who were randomly placed in two groups: the experimental and control groups, which each consisted of 20 people. We provided eight positive psychotherapy sessions for only the experimental group.
Results


After MANCOVA was conducted, the results showed that positive psychotherapy significantly decreased alexithymia and depression in the test population.",2022,"After MANCOVA was conducted, the results showed that positive psychotherapy significantly decreased alexithymia and depression in the test population.","['40 participants aged 20-40 with a high score in the Beck Depression Inventory and Toronto Alexithymia Questionnaire were recruited from women referred to a psychology clinic for divorce-related problems', 'Women Applying for a Divorce']","['Positive Psychotherapy', 'positive psychotherapy']","['Depression and Alexithymia', 'alexithymia and depression']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3811912', 'cui_str': 'Psychology clinic'}, {'cui': 'C0012828', 'cui_str': 'Divorce'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}]",40.0,0.0621853,"After MANCOVA was conducted, the results showed that positive psychotherapy significantly decreased alexithymia and depression in the test population.","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Khalili', 'Affiliation': 'Payame Noor University, Iran.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Khalili', 'Affiliation': 'Department of Educational and Counselling Psychology, McGill University, Montreal, Canada.'}, {'ForeName': 'Eisa', 'Initials': 'E', 'LastName': 'Jafari', 'Affiliation': 'Payame Noor University, Iran.'}]",Depression research and treatment,['10.1155/2022/8446611']
2690,35223072,Using breastfeeding images to promote breastfeeding among young adults.,"Young adults' reactions to breastfeeding images were assessed using varied approaches. In Study 1, participants viewed posters from a breastfeeding campaign; many anticipated negative reaction to the campaign. In Study 2, participants viewed novel infant-feeding posters; breastfeeding posters were viewed for less time than bottle-feeding posters, regardless of the task assigned. In Study 3, participants were asked to rate their comfort level viewing infant-feeding images; greater discomfort was reported for breastfeeding images. Taken together, we argue that many young adults expect, and experience, discomfort viewing breastfeeding, but it is important to continue using breastfeeding images in promotion efforts.",2016,"In Study 3, participants were asked to rate their comfort level viewing infant-feeding images; greater discomfort was reported for breastfeeding images.",['young adults'],[],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],[],3.0,0.0362043,"In Study 3, participants were asked to rate their comfort level viewing infant-feeding images; greater discomfort was reported for breastfeeding images.","[{'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Austen', 'Affiliation': 'St. Francis Xavier University, Canada.'}, {'ForeName': 'Joey', 'Initials': 'J', 'LastName': 'Dignam', 'Affiliation': 'St. Francis Xavier University, Canada.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Hauf', 'Affiliation': 'St. Francis Xavier University, Canada.'}]",Health psychology open,['10.1177/2055102916671015']
2691,34856641,Alcohol withdrawal symptoms predict corticostriatal dysfunction that is reversed by prazosin treatment in alcohol use disorder.,"Chronic alcohol use increases risk of alcohol withdrawal symptoms (AW) and disrupts stress biology and resilient coping, thereby promoting excessive alcohol intake. Chronic alcohol intake and multiple alcohol detoxifications are known to impair brain medial prefrontal cortex (mPFC) and striatal functioning, regions involved in regulating stress, craving and alcohol intake. In two related studies, we examined whether AW predicts this functional brain pathology and whether Prazosin versus Placebo treatment may reverse these effects. In Study 1, patients with Alcohol Use Disorder (AUD) (N = 45) with varying AW levels at treatment entry were assessed to examine AW effects on corticostriatal responses to stress, alcohol cue and neutral visual images with functional magnetic resonance imaging (fMRI). In Study 2, 23 AUD patients entering a 12-week randomised controlled trial (RCT) of Prazosin, an alpha1 adrenergic antagonist that decreased withdrawal-related alcohol intake in laboratory animals, participated in two fMRI sessions at pretreatment and also at week 9-10 of chronic treatment (Placebo: N = 13; Prazosin: N = 10) to assess Prazosin treatment effects on alcohol-related cortico-striatal dysfunction. Study 1 results indicated that higher AW predicted greater disruption in brain mPFC and striatal response to stress and alcohol cues (p < 0.001, family-wise error [FWE] correction) and also subsequently greater heavy drinking days (HDD) in early treatment (p < 0.01). In Study 2, Prazosin versus Placebo treatment reversed mPFC-striatal dysfunction (p < 0.001, FWE), which in turn predicted fewer drinking days (p < 0.01) during the 12-week treatment period. These results indicate that AW is a significant predictor of alcohol-related prefrontal-striatal dysfunction, and Prazosin treatment reversed these effects that in turn contributed to improved alcohol treatment outcomes.",2022,"In Study 2, Prazosin versus Placebo treatment reversed mPFC-striatal dysfunction (p < 0.001, FWE), which in turn predicted fewer drinking days (p < 0.01) during the 12-week treatment period.","['23 AUD patients entering a 12-week randomised controlled trial (RCT) of', 'patients with Alcohol Use Disorder (AUD']","['Placebo', 'prazosin', 'Prazosin', 'chronic treatment (Placebo: N\u2009=\u200913; Prazosin', 'Prazosin versus Placebo', 'Prazosin, an alpha1 adrenergic antagonist']","['corticostriatal responses to stress, alcohol cue and neutral visual images with functional magnetic resonance imaging (fMRI', 'heavy drinking days (HDD', 'alcohol-related cortico-striatal dysfunction', 'mPFC-striatal dysfunction', 'disruption in brain mPFC and striatal response to stress and alcohol cues']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032912', 'cui_str': 'Prazosin'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0304512', 'cui_str': 'Alpha-1 adrenergic receptor antagonist'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",45.0,0.0110697,"In Study 2, Prazosin versus Placebo treatment reversed mPFC-striatal dysfunction (p < 0.001, FWE), which in turn predicted fewer drinking days (p < 0.01) during the 12-week treatment period.","[{'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Yale Stress Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Nia', 'Initials': 'N', 'LastName': 'Fogelman', 'Affiliation': 'Yale Stress Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wemm', 'Affiliation': 'Yale Stress Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Angarita', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Dongju', 'Initials': 'D', 'LastName': 'Seo', 'Affiliation': 'Yale Stress Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Hermes', 'Affiliation': 'Yale Stress Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}]",Addiction biology,['10.1111/adb.13116']
2692,34856563,Transient End-Tidal Carbon Dioxide Elevation During Pediatric Upper Endoscopy With Carbon Dioxide Insufflation: Is It True Hypercapnia?,"BACKGROUND


Endoscopic insufflation, long performed using air, is being replaced by carbon dioxide (CO2) at many pediatric centers, despite limited published data on its use in children. We have previously demonstrated that CO2 use during esophagogastroduodenoscopy (EGD) in non-intubated children is associated with transient elevations of end-tidal CO2 (EtCO2). This observation raised concerns about possible CO2 inhalation and systemic absorption. Here, we investigate this concern by concurrently measuring both EtCO2 and transcutaneous CO2 (tCO2) during upper endoscopic procedures in children.
AIM


To determine if elevations in EtCO2 levels seen in non-intubated children undergoing CO2 insufflation during EGD are associated with elevated systemic CO2 levels.
METHODS


Double-blinded, prospective, randomized clinical trial. Children were randomized 1:1 to receive either CO2 or air for endoscopic insufflation. EtCO2 was sampled with a CO2-sampling nasal cannula and tCO2 was monitored using the Radiometer transcutaneous monitoring device.
RESULTS


Fifty nine patients were enrolled; 30 patients in the CO2 insufflation group and 29 in the air group. All patients underwent a procedure involving an EGD. Transient elevations in EtCO2 (defined as >60 mmHg) were observed only in the CO2 insufflation group. This contrasted with the similar elevations of tCO2 between the CO2 and air insufflation groups. None of these events were of clinically significant magnitude or duration.
CONCLUSION


This study demonstrates that the observed transient elevations in EtCO2 seen during EGD in non-intubated children receiving CO2 insufflation are most likely measurements of eructated CO2 without evidence of excessive systemic absorption of CO2.",2022,Transient elevations in EtCO2 (defined as >60 mmHg) were observed only in the CO2 insufflation group.,"['Fifty', 'nine patients were enrolled; 30 patients in the CO2 insufflation group and 29 in the air group', 'children', 'non-intubated children undergoing CO2 insufflation during EGD']","['Carbon Dioxide Insufflation', 'CO2 or air for endoscopic insufflation', 'carbon dioxide (CO2', 'EtCO2 and transcutaneous CO2 (tCO2', 'esophagogastroduodenoscopy (EGD', 'procedure involving an EGD']","['Transient End-Tidal Carbon Dioxide Elevation', 'Transient elevations in EtCO2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}]",59.0,0.157973,Transient elevations in EtCO2 (defined as >60 mmHg) were observed only in the CO2 insufflation group.,"[{'ForeName': 'Chinenye R', 'Initials': 'CR', 'LastName': 'Dike', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, Pancreatology and Nutrition, Stead Family Department of Pediatrics, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Warren P', 'Initials': 'WP', 'LastName': 'Bishop', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, Pancreatology and Nutrition, Stead Family Department of Pediatrics, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Titler', 'Affiliation': 'Department of Anesthesiology; Division of Pediatric Anesthesia, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Riad', 'Initials': 'R', 'LastName': 'Rahhal', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, Pancreatology and Nutrition, Stead Family Department of Pediatrics, University of Iowa, Iowa City, IA.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000003363']
2693,34894266,"Apremilast in a Japanese subgroup with Behçet's syndrome: Results from a Phase 3, randomised, double-blind, placebo-controlled study.","OBJECTIVES


Apremilast efficacy and safety was assessed in a prespecified subgroup of Japanese patients with oral ulcers associated with Behçet's syndrome from a Phase 3 randomized, placebo-controlled, double-blind study of apremilast (RELIEF).
METHODS


The primary end point was area under the curve for number of oral ulcers during the 12-week placebo-controlled phase (AUCWk0-12). Key secondary end points were change from baseline in oral ulcer pain, complete oral ulcer resolution, and measures of disease activity and quality of life (QoL).
RESULTS


Thirty-nine Japanese patients were randomised (apremilast 30 mg BID: n = 19; placebo: n = 20). Improvements at Week 12 were observed for apremilast vs. placebo in AUCWk0-12 for the number of oral ulcers (115.9 vs. 253.3; nominal P = 0.0168); 57.9% vs. 25.0% achieved complete oral ulcer resolution, 47.4% vs. 0.0% achieved oral ulcer resolution by Week 6 and maintained oral ulcer-free status for ≥6 additional weeks; mean change from baseline in BSAS was -10.5 vs. 0.5. Favourable effects were observed for apremilast vs. placebo in other secondary end points, including QoL. Clinical benefits were sustained over 28 weeks of continued apremilast treatment. Adverse events were consistent with apremilast's known safety profile.
CONCLUSIONS


Apremilast reduced the number of oral ulcers and overall disease activity in this Japanese subgroup with Behçet's syndrome.",2022,"Favourable effects were observed for apremilast vs. placebo in other secondary end points, including QoL. Clinical benefits were sustained over 28 weeks of continued apremilast treatment.","[""Japanese subgroup with Behçet's syndrome"", 'Thirty-nine Japanese patients', ""Japanese patients with oral ulcers associated with Behçet's syndrome""]","['apremilast (RELIEF', 'placebo']","['oral ulcer resolution', 'oral ulcer pain, complete oral ulcer resolution, and measures of disease activity and quality of life (QoL', 'complete oral ulcer resolution', 'area under the curve for number of oral ulcers', 'number of oral ulcers and overall disease activity', 'QoL. Clinical benefits', 'Adverse events']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0004943', 'cui_str': ""Behcet's syndrome""}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149745', 'cui_str': 'Ulcer of mouth'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C1678805', 'cui_str': 'apremilast'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0149745', 'cui_str': 'Ulcer of mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",39.0,0.682763,"Favourable effects were observed for apremilast vs. placebo in other secondary end points, including QoL. Clinical benefits were sustained over 28 weeks of continued apremilast treatment.","[{'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Takeno', 'Affiliation': 'Department of Allergy and Rheumatology, Nippon Medical School, Musashi Kosugi Hospital, Kanagawa, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Dobashi', 'Affiliation': 'Division of Hematology, Rheumatology and Respiratory Medicine, Department of Internal Medicine, Faculty of Medicine, Kagawa University, Kagawa, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': ''}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Kono', 'Affiliation': 'Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shouji', 'Initials': 'S', 'LastName': 'Sugii', 'Affiliation': 'Department of Rheumatic Diseases, Tokyo Metropolitan Matsuzawa Hospital, Tokyo, Japan.'}, {'ForeName': 'Mitsumasa', 'Initials': 'M', 'LastName': 'Kishimoto', 'Affiliation': 'Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'McCue', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Paris', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Ishigatsubo', 'Affiliation': 'Department of Internal Medicine and Clinical Immunology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}]",Modern rheumatology,['10.1093/mr/roab008']
2694,34893360,"Reply to Abhay Singh and Prasant Nayak's Letter to the Editor re: Luke Harper, T. Blanc, M. Peycelon, et al. Circumcision and Risk of Febrile Urinary Tract Infection in Boys with Posterior Urethral Valves: Result of the CIRCUP Randomized Trial. Eur Urol. 2022;81:64-72.",,2022,,['Boys with Posterior Urethral Valves'],[],[],"[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0238506', 'cui_str': 'Congenital posterior urethral valves'}]",[],[],,0.102705,,"[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': 'Department of Paediatric Surgery, Hôpital Pellegrin-Enfants, CHU Bordeaux, Bordeaux, France. Electronic address: harper_luke@hotmail.com.'}]",European urology,['10.1016/j.eururo.2021.11.028']
2695,34881919,Stressor-elicited smoking and craving during a smoking cessation attempt.,"Stressors can undermine smokers' attempts to quit smoking. Although contemporary theories and animal models support this idea, human research has struggled to demonstrate definitively the relationship between stressors and smoking. Researchers have employed more ecologically valid methods like ecological momentary assessment to address this question, but studies focusing explicitly on stressors remain sparse and findings inconsistent. The purpose of this study was to examine the effect of stressful event intensity on smoking and craving among cigarette smokers during a quit attempt. We conducted preregistered, complementary concurrent and prospective (i.e., 8-hour lag window between stressful event and outcomes) analyses to maximize statistical power and provide temporal ordering, respectively. We also conducted follow-up moderation (Lag × Stressful Event Intensity) analyses. We hypothesized that smokers would be more likely to report both smoking and craving as the intensity of stressful events increased. Cigarette smokers ( N  = 125; 77 male) were randomly assigned to take nicotine replacement therapy (NRT) or placebo and provided 4x daily self-reports during the first 2 weeks of a quit attempt. Stressful events increased craving and the probability of smoking in concurrent analyses, and lag moderated the effect of stressful event intensity in follow-up prospective lagged analyses. NRT reduced the probability of smoking but not craving and did not moderate the effect of stressful events on smoking or craving. This study supports a prospective relationship between stressful events and smoking/craving in situ and demonstrates that NRT does not reduce the impact of stressors on smoking or craving. (PsycInfo Database Record (c) 2022 APA, all rights reserved).",2022,NRT reduced the probability of smoking but not craving and did not moderate the effect of stressful events on smoking or craving.,"['cigarette smokers during a quit attempt', 'Cigarette smokers ( N  = 125; 77 male']","['nicotine replacement therapy (NRT) or placebo', 'NRT']",[],"[{'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0252003,NRT reduced the probability of smoking but not craving and did not moderate the effect of stressful events on smoking or craving.,"[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Schultz', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Gaylen E', 'Initials': 'GE', 'LastName': 'Fronk', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Jaume', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Katherine P', 'Initials': 'KP', 'LastName': 'Magruder', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Curtin', 'Affiliation': 'Department of Psychology.'}]",Journal of psychopathology and clinical science,['10.1037/abn0000702']
2696,35069580,"Induction of Functional Specific Antibodies, IgG-Secreting Plasmablasts and Memory B Cells Following BCG Vaccination.","Tuberculosis (TB) is a major global health problem and the only currently-licensed vaccine, BCG, is inadequate. Many TB vaccine candidates are designed to be given as a boost to BCG; an understanding of the BCG-induced immune response is therefore critical, and the opportunity to relate this to circumstances where BCG does confer protection may direct the design of more efficacious vaccines. While the T cell response to BCG vaccination has been well-characterized, there is a paucity of literature on the humoral response. We demonstrate BCG vaccine-mediated induction of specific antibodies in different human populations and macaque species which represent important preclinical models for TB vaccine development. We observe a strong correlation between antibody titers in serum versus plasma with modestly higher titers in serum. We also report for the first time the rapid and transient induction of antibody-secreting plasmablasts following BCG vaccination, together with a robust and durable memory B cell response in humans. Finally, we demonstrate a functional role for BCG vaccine-induced specific antibodies in opsonizing mycobacteria and enhancing macrophage phagocytosis  in vitro , which may contribute to the BCG vaccine-mediated control of mycobacterial growth observed. Taken together, our findings indicate that the humoral immune response in the context of BCG vaccination merits further attention to determine whether TB vaccine candidates could benefit from the induction of humoral as well as cellular immunity.",2021,We demonstrate BCG vaccine-mediated induction of specific antibodies in different human populations and macaque species which represent important preclinical models for TB vaccine development.,['humans'],[],[],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]",[],[],,0.0580123,We demonstrate BCG vaccine-mediated induction of specific antibodies in different human populations and macaque species which represent important preclinical models for TB vaccine development.,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bitencourt', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Marco Polo', 'Initials': 'MP', 'LastName': 'Peralta-Álvarez', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Morven', 'Initials': 'M', 'LastName': 'Wilkie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Jacobs', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wright', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Salem', 'Initials': 'S', 'LastName': 'Salman Almujri', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Shuailin', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Harris', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Smith', 'Affiliation': 'Department of Infection Biology, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Elias', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'White', 'Affiliation': 'United Kingdom Health Security Agency, Porton Down, Salisbury, United Kingdom.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Satti', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sally S', 'Initials': 'SS', 'LastName': 'Sharpe', 'Affiliation': 'United Kingdom Health Security Agency, Porton Down, Salisbury, United Kingdom.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': ""O'Shea"", 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McShane', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Tanner', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}]",Frontiers in immunology,['10.3389/fimmu.2021.798207']
2697,35108339,Systems analysis of immune responses to attenuated P. falciparum malaria sporozoite vaccination reveals excessive inflammatory signatures correlating with impaired immunity.,"Immunization with radiation-attenuated sporozoites (RAS) can confer sterilizing protection against malaria, although the mechanisms behind this protection are incompletely understood. We performed a systems biology analysis of samples from the Immunization by Mosquito with Radiation Attenuated Sporozoites (IMRAS) trial, which comprised P. falciparum RAS-immunized (PfRAS), malaria-naive participants whose protection from malaria infection was subsequently assessed by controlled human malaria infection (CHMI). Blood samples collected after initial PfRAS immunization were analyzed to compare immune responses between protected and non-protected volunteers leveraging integrative analysis of whole blood RNA-seq, high parameter flow cytometry, and single cell CITEseq of PBMCs. This analysis revealed differences in early innate immune responses indicating divergent paths associated with protection. In particular, elevated levels of inflammatory responses early after the initial immunization were detrimental for the development of protective adaptive immunity. Specifically, non-classical monocytes and early type I interferon responses induced within 1 day of PfRAS vaccination correlated with impaired immunity. Non-protected individuals also showed an increase in Th2 polarized T cell responses whereas we observed a trend towards increased Th1 and T-bet+ CD8 T cell responses in protected individuals. Temporal differences in genes associated with natural killer cells suggest an important role in immune regulation by these cells. These findings give insight into the immune responses that confer protection against malaria and may guide further malaria vaccine development. Trial registration: ClinicalTrials.gov NCT01994525.",2022,"Specifically, non-classical monocytes and early type I interferon responses induced within 1 day of PfRAS vaccination correlated with impaired immunity. Non-protected individuals also showed an increase in Th2 polarized T cell responses whereas we observed a trend towards increased Th1 and T-bet+ CD8 T cell responses in protected individuals.",[],['radiation-attenuated sporozoites (RAS'],"['Th2 polarized T cell responses', 'Th1 and T-bet+ CD8 T cell responses']",[],"[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0562648', 'cui_str': 'Kingdom Protozoa sporozoite'}]","[{'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}]",,0.128076,"Specifically, non-classical monocytes and early type I interferon responses induced within 1 day of PfRAS vaccination correlated with impaired immunity. Non-protected individuals also showed an increase in Th2 polarized T cell responses whereas we observed a trend towards increased Th1 and T-bet+ CD8 T cell responses in protected individuals.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington, United States of America.""}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Hertoghs', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington, United States of America.""}, {'ForeName': 'Fergal J', 'Initials': 'FJ', 'LastName': 'Duffy', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington, United States of America.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Carnes', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington, United States of America.""}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'McDermott', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington, United States of America.""}, {'ForeName': 'Maxwell L', 'Initials': 'ML', 'LastName': 'Neal', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington, United States of America.""}, {'ForeName': 'Katharine V', 'Initials': 'KV', 'LastName': 'Schwedhelm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'De Rosa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Aitchison', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington, United States of America.""}, {'ForeName': 'Kenneth D', 'Initials': 'KD', 'LastName': 'Stuart', 'Affiliation': ""Center for Global Infectious Disease Research, Seattle Children's Research Institute, Seattle, Washington, United States of America.""}]",PLoS pathogens,['10.1371/journal.ppat.1010282']
2698,35226523,"In type 2 diabetes with increased CV risk, tirzepatide reduced HbA 1c  vs. glargine at 52 wk.","SOURCE CITATION


Del Prato S, Kahn SE, Pavo I, et al.  Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial.  Lancet. 2021;398:1811-24. 34672967.",2022,"Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial.  ",['type 2 diabetes and increased cardiovascular risk (SURPASS-4'],['Tirzepatide versus insulin glargine'],[],"[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]",[],,0.133127,"Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial.  ","[{'ForeName': 'Madhusree', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Veterans Hospital,, San Diego, California, USA (M.S.).'}]",Annals of internal medicine,['10.7326/J22-0009']
2699,35222657,Effectiveness of Care for Child Development Program on the Sensitivity and Responsiveness Skills of Mothers.,"Objectives


The present study was done to analyze the impact of the ""care for child development"" program on the sensitivity and responsiveness skills among mothers of children at risk of developmental delay.
Materials & Methods


This study was a quasi-experimental research with a pretest-posttest design and experimental and control groups. The statistical population included all mothers with children at risk of developmental delay in Tabriz. Fifty mothers were selected through purposive sampling. Then, they were divided into two groups of 25 cases (one experimental group and one control group) using simple random sampling. The experimental group received training about the ""care for child development"" program, while the control group received no training. The Social-Emotional Assessment/Evaluation Measure Family Profile (SEAM TM family profile) and Maternal Caregiving Quality Scale were the research measurement tools. The obtained data were evaluated by analysis of covariance (ANCOVA) and independent t-test using SPSS software version 20.
Results


There was a significant difference between the experimental and control groups in maternal caregiving quality and responsiveness, provision of appropriate activities, predictable programs, and provision of play environment and safe home (P <0.05).
Conclusion


The results showed that the care for child development program has positive effects on sensitivity and responsiveness skills of mothers of children at risk of developmental delays and can be considered and applied as a practical plan in national health policies.",2022,"There was a significant difference between the experimental and control groups in maternal caregiving quality and responsiveness, provision of appropriate activities, predictable programs, and provision of play environment and safe home (P <0.05).
","['Mothers', 'mothers of children at risk of developmental delay', 'mothers with children at risk of developmental delay in Tabriz', 'Fifty mothers were selected through purposive sampling']","['Care for Child Development Program', 'training about the ""care for child development"" program, while the control group received no training', 'care for child development"" program']","['sensitivity and responsiveness skills', 'Social-Emotional Assessment/Evaluation Measure Family Profile (SEAM TM family profile) and Maternal Caregiving Quality Scale', 'maternal caregiving quality and responsiveness, provision of appropriate activities, predictable programs, and provision of play environment and safe home', 'Sensitivity and Responsiveness Skills']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0424605', 'cui_str': 'Developmental delay'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",50.0,0.00949051,"There was a significant difference between the experimental and control groups in maternal caregiving quality and responsiveness, provision of appropriate activities, predictable programs, and provision of play environment and safe home (P <0.05).
","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bahari Gharehgoz', 'Affiliation': 'Psychology and Education of Exceptional Children, Department of Educational Sciences, Farhangian University,Tehran, Iran.'}, {'ForeName': 'Seifollah', 'Initials': 'S', 'LastName': 'Heidarabadi', 'Affiliation': 'Department of Pediatric, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Alizadeh', 'Affiliation': ""Faculty of Psychology & Education AllamehTabataba'i University, Tehran, Iran.""}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Asgari', 'Affiliation': ""Assessment and Measurement Department, Faculty of Psychology, AllamehTabataba'i University, Tehran, Iran.""}]",Iranian journal of child neurology,['10.22037/ijcn.v16i1.29797']
2700,35222905,"Short- and long-term effects of whole-body photobiomodulation on pain, functionality, tissue quality, central sensitisation and psychological factors in a population suffering from fibromyalgia: protocol for a triple-blinded randomised clinical trial.","Background


The development of an integral and global treatment to improve the quality of life in those with fibromyalgia syndrome (FMS) is challenging. The aim of this study is to investigate the impact of whole-body photobiomodulation (PBM) on pain perception, functionality, quality of soft tissue, central sensitisation and psychological factors in patients suffering with FMS.
Methods


This study is a randomised, placebo-controlled clinical trial. A total of 44 participants will be recruited in a private care practice and randomised to receive either a whole-body PBM therapy programme or placebo in the same care centre. The parameters of the PBM programme are as follows: wavelengths of red and near-infrared LEDs 50:50 ratio with 660-850 nanometers; fluence of 25.2 J/cm 2 ; treatment time of 1200 s and a total power emitted of 967 W. Treatment sessions will be 3 times weekly for a period of 4 weeks, totalling 12 treatment sessions. Primary outcome will be pain (Numeric Pain Rating Scale; Widespread Pain Index; Symptom Severity Score). Secondary outcomes will be functionality (Fibromyalgia Impact Questionnaire; the Leisure Time Physical Activity Instrument), quality of soft tissue (elastography), central sensitisation (pain pressure threshold and the Autonomic Symptom Profile) and psychological factors (Pain Catastrophising scale, Tampa Scale, Self-Efficacy questionnaire). Assessments will be at baseline (T1), after session 6 (T2), after treatment (T3) and 2 weeks (T4), 3 (T5) and 6 (T6) month follow-up.
Discussion


PBM therapy has been shown to reduce pain and inflammation and to increase the rate of tissue repair for a wide range of conditions, but its potential use as a whole-body treatment in FM is yet to be explored. This trial will investigate whether whole-body PBM therapy is effective at reducing pain intensity, improving functionality, quality of soft tissue, central sensitisation symptoms and psychological measurements. Furthermore, 3- and 6-month follow-up will investigate long-term efficacy of this treatment.
Trial registration


NCT04248972. Registered on January 29, 2020, https://clinicaltrials.gov/ct2/show/NCT04248972?term=navarro-ledesma+santiago&draw=2&rank=2.",2022,"Discussion


PBM therapy has been shown to reduce pain and inflammation and to increase the rate of tissue repair for a wide range of conditions, but its potential use as a whole-body treatment in FM is yet to be explored.","['patients suffering with FMS', 'population suffering from fibromyalgia', '44 participants will be recruited in a private care practice']","['whole-body photobiomodulation', 'whole-body PBM therapy programme or placebo', 'whole-body PBM therapy', 'placebo', 'whole-body photobiomodulation (PBM']","['pain intensity, improving functionality, quality of soft tissue, central sensitisation symptoms and psychological measurements', 'functionality (Fibromyalgia Impact Questionnaire; the Leisure Time Physical Activity Instrument), quality of soft tissue (elastography), central sensitisation (pain pressure threshold and the Autonomic Symptom Profile) and psychological factors (Pain Catastrophising scale, Tampa Scale, Self-Efficacy questionnaire', 'pain and inflammation', 'pain, functionality, tissue quality, central sensitisation and psychological factors', 'pain perception, functionality, quality of soft tissue, central sensitisation and psychological factors', 'quality of life', 'pain (Numeric Pain Rating Scale; Widespread Pain Index; Symptom Severity Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",44.0,0.187155,"Discussion


PBM therapy has been shown to reduce pain and inflammation and to increase the rate of tissue repair for a wide range of conditions, but its potential use as a whole-body treatment in FM is yet to be explored.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Navarro-Ledesma', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, Campus of Melilla, University of Granada, Querol Street, 5, 52004 Melilla, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gonzalez-Muñoz', 'Affiliation': 'Clinica Ana Gonzalez, Malaga, Spain.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Carroll', 'Affiliation': 'THOR Photomedicine Ltd, Chesham, Buckinghamshire, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Burton', 'Affiliation': 'THOR Photomedicine Ltd, Chesham, Buckinghamshire, UK.'}]",Therapeutic advances in chronic disease,['10.1177/20406223221078095']
2701,35222903,Nicotinamide supplementation in diabetic nonalcoholic fatty liver disease patients: randomized controlled trial.,"Background


Nicotinamide has been reported to protect against liver steatosis and metabolic imbalances in nonalcoholic fatty liver disease (NAFLD) in animal models.
Objectives


The objective was to investigate the efficacy and safety of nicotinamide supplementation in diabetic NAFLD patients.
Design


This is a prospective randomized controlled open label study.
Methods


Seventy diabetic NAFLD patients were randomly assigned either to the nicotinamide group ( n  = 35) who received nicotinamide 1000 mg once daily for 12 weeks in addition to their antidiabetic therapy or the control group ( n  = 35) who received their antidiabetic therapy only. The primary outcome was improvement in steatosis score, while secondary outcomes included assessment of liver stiffness, liver enzymes, lipid profile, insulin resistance, serum malondialdehyde, serum adiponectin, and patients' quality of life (QOL).
Results


Only 61 patients completed the study; 31 in the nicotinamide group and 30 in the control group. Comparisons between groups and within groups revealed nonsignificant changes in steatosis and fibrosis scores. However, significant reduction was observed in liver enzymes with a median decrease in alanine transaminase of 26.6%  versus  0.74% in nicotinamide and control groups, respectively. After 12 weeks of treatment, the nicotinamide group showed significantly lower levels of low-density lipoprotein cholesterol ( p  value = 0.004), total cholesterol ( p  value = 0.006), and insulin resistance marker ( p  value = 0.005) compared with control. Serum triglycerides, malondialdehyde, and adiponectin levels were all comparable between the two groups. Regarding QOL, a significant improvement was detected in the total scores and the activity and fatigue domains scores.
Conclusion


Nicotinamide at a dose of 1000 mg daily was tolerable, improved metabolic abnormalities and QOL of diabetic NAFLD patients with no effect on liver fibrosis or steatosis.
Trial Registration


The study was registered at clinicaltrials.gov and given the ID number: ' NCT03850886 '. https://clinicaltrials.gov/ct2/show/NCT03850886.",2022,"However, significant reduction was observed in liver enzymes with a median decrease in alanine transaminase of 26.6%  versus  0.74% in nicotinamide and control groups, respectively.","['diabetic nonalcoholic fatty liver disease patients', 'diabetic NAFLD patients', '61 patients completed the study; 31 in the nicotinamide group and 30 in the control group', 'Methods\n\n\nSeventy diabetic NAFLD patients']","['nicotinamide 1000 mg once daily for 12 weeks in addition to their antidiabetic therapy or the control group ( n \u2004=\u200435) who received their antidiabetic therapy only', 'nicotinamide', 'Nicotinamide supplementation', 'nicotinamide supplementation']","['total scores and the activity and fatigue domains scores', 'liver enzymes', 'total cholesterol', 'liver fibrosis or steatosis', 'alanine transaminase', 'insulin resistance marker', ""assessment of liver stiffness, liver enzymes, lipid profile, insulin resistance, serum malondialdehyde, serum adiponectin, and patients' quality of life (QOL"", 'efficacy and safety', 'Serum triglycerides, malondialdehyde, and adiponectin levels', 'steatosis and fibrosis scores', 'metabolic abnormalities and QOL', 'levels of low-density lipoprotein cholesterol', 'steatosis score']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",,0.118295,"However, significant reduction was observed in liver enzymes with a median decrease in alanine transaminase of 26.6%  versus  0.74% in nicotinamide and control groups, respectively.","[{'ForeName': 'Rasha R', 'Initials': 'RR', 'LastName': 'El-Kady', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Amani K', 'Initials': 'AK', 'LastName': 'Ali', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Lamia M', 'Initials': 'LM', 'LastName': 'El Wakeel', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Nagwa A', 'Initials': 'NA', 'LastName': 'Sabri', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'May A', 'Initials': 'MA', 'LastName': 'Shawki', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo 11566, Egypt.'}]",Therapeutic advances in chronic disease,['10.1177/20406223221077958']
2702,35222902,Clinical Effects of Acupuncture for Stroke Patients Recovery.,"Stroke is assumed as one of the common cerebrovascular diseases that endangers human health and life. Its incidence and mortality rates are high, while survivors (50% to 70%) suffer from different degrees of disability. Hemiplegia is a common disability after stroke, mainly manifested as muscle weakness of the affected side, limb spasm, and limited activity, which severely impacts a patient's daily life. There are various rehabilitation methods for stroke hemiplegia, including modern rehabilitation medicine, motor therapy, acupuncture, and rehabilitation robot. The cost and effect of different rehabilitation methods are not the same. It is the focus to find an economical and effective rehabilitation method. In this paper, 128 stroke patients aged 41 to 73 hospitalized between January 2019 and January 2021 were analyzed. The intervention group used standard physical therapy and traditional acupuncture therapy, and the control group only used standard physical therapy. We used RStudio 1.1.419 (RStudio Corporation) for analysis. Experimental results show that the short-term efficacy of the intervention group is better than that of the control group. The intervention group was better than the control group in recovery from injury during rehabilitation, degree of muscle spasm, self-care ability in daily life, and overall degree of damage. In the long-term efficacy analysis, we can see that with the increase in the number of acupuncture, the efficacy of the intervention group is still better than that of the control group. Compared with physical rehabilitation alone, acupuncture has better short-term, and long-term clinical effects for stroke patients improves motor dysfunction and improves the quality of life and independence of stroke patients. With the increase in the number of acupuncture treatments, the patient's rehabilitation effect will be better.",2022,"The intervention group was better than the control group in recovery from injury during rehabilitation, degree of muscle spasm, self-care ability in daily life, and overall degree of damage.","['Stroke Patients Recovery', '128 stroke patients aged 41 to 73 hospitalized between January 2019 and January 2021 were analyzed']","['standard physical therapy and traditional acupuncture therapy, and the control group only used standard physical therapy', 'Acupuncture', 'physical rehabilitation alone, acupuncture']","['mortality rates', 'quality of life and independence of stroke patients', 'motor dysfunction']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}]",73.0,0.0158085,"The intervention group was better than the control group in recovery from injury during rehabilitation, degree of muscle spasm, self-care ability in daily life, and overall degree of damage.","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Rehabilitation Department of Traditional Chinese Medicine, Hanyang Hospital of Wuhan University of Science and Technology, Wuhan 430050, China.'}, {'ForeName': 'Bingjie', 'Initials': 'B', 'LastName': 'Cheng', 'Affiliation': ""Traditional Chinese Medicine Department, Hubei No. 3 People's Hospital of Jianghan University, Wuhan 430033, China.""}]",Journal of healthcare engineering,['10.1155/2022/9962421']
2703,35222900,Application of Data Mining in the Effect of Traditional Chinese Medicine on the Rehabilitation of Cerebral Spasticity of Lower Extremity Exercise Energy.,"In this article, we have examined the effect of acupoint injection of mecobalamin on the nerve function of the lower limbs of stroke patients by giving acupoint injection of mecobalamin for 2 weeks in patients with stroke, effectively fusing acupuncture, acupoints, and drugs in traditional Chinese medicine to rehabilitate the effect of motor function and activities of daily living. For this purpose, a total of 60 study cases will be screened in the study. They are randomly divided into experimental group and control group: the control group will be treated with conventional stroke treatment and nursing, and the experimental group will be treated with bilateral acupoint injection of mecobalamin; once a day, after 14 days of continuous injection, we observed and intervened the lower limb nerve function, motor function, and activities of daily living of the two groups before and after the treatment and statistically analyzed the data so as to obtain the clinical effect of the treatment on the lower limb rehabilitation of stroke patients. Before the intervention, the general information and basic clinical data of the two groups of subjects were collected for baseline comparison, and the differences between the two groups of subjects' lower limb nerve function, motor function and activities of daily living before the intervention were compared. Comparison of lower limb neurological deficits mainly include comparison between groups and comparison within groups. Comparison of lower limb motor function mainly include comparison between groups and comparison within groups. (1) Acupoint injection of mecobalamin therapy and simple stroke rehabilitation therapy have good results. (2) Acupoint injection of mecobalamin can improve the neurological deficits of the lower limbs of stroke patients more than simple conventional stroke therapy, and it also has a rehabilitation effect in nourishing the nerves, improving circulation, and protecting the brain. (3) Point-injection mecobalamin therapy is more effective than conventional stroke therapy in improving the motor function of the lower limbs and promoting the rehabilitation of the lower limbs of patients with ischemic stroke. (4) Acupoint injection of mecobalamin therapy can improve the activities of daily living of patients with ischemic stroke and improve the quality of life of patients compared with conventional stroke therapy alone.",2022,"(2) Acupoint injection of mecobalamin can improve the neurological deficits of the lower limbs of stroke patients more than simple conventional stroke therapy, and it also has a rehabilitation effect in nourishing the nerves, improving circulation, and protecting the brain.","['patients with stroke', 'patients with ischemic stroke']","['Traditional Chinese Medicine', 'mecobalamin therapy and simple stroke rehabilitation therapy', 'Acupoint injection of mecobalamin therapy', 'acupoint injection of mecobalamin', 'conventional stroke therapy alone', 'Acupoint injection of mecobalamin', 'conventional stroke treatment and nursing, and the experimental group will be treated with bilateral acupoint injection of mecobalamin']","['limb nerve function, motor function, and activities of daily living', 'limb nerve function, motor function and activities of daily living', 'activities of daily living of patients with ischemic stroke', 'neurological deficits', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.00940893,"(2) Acupoint injection of mecobalamin can improve the neurological deficits of the lower limbs of stroke patients more than simple conventional stroke therapy, and it also has a rehabilitation effect in nourishing the nerves, improving circulation, and protecting the brain.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Rehabilitation Department of Traditional Chinese Medicine, Hanyang Hospital of Wuhan University of Science and Technology, Wuhan 430000, China.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430000, China.'}]",Journal of healthcare engineering,['10.1155/2022/9746906']
2704,35222888,The Efficacy of Psychological Care and Chinese Herbal Decoction in Postoperative Chemotherapy Patients with Endometrial Cancer.,"Background


In recent years, the incidence of endometrial cancer (EC) has been on the rise worldwide. The purpose of this study was to investigate the efficacy of psychological care and Chinese herbal decoction in EC patients with postoperative chemotherapy.
Methods


80 EC patients with postoperative chemotherapy were randomly divided into the observation group and control group. The control group was given psychotherapy. The observation group was given psychological care plus Chinese herbal decoction treatment. HE4, CA125, traditional Chinese medicine (TCM) syndrome scores, toxic and side effects, and quality of life scores before and after treatment were observed.
Results


After treatment, the total effective rate of the observation group was higher than that of the control group. After treatment, serum HE4 and CA125 levels in the observation group were lower than those in the control group. In addition, CD3+ and CD4+ levels in the observation group were higher than those in the control group. Meanwhile, the CD8+ level in the observation group was lower than that in the control group. Compared with the control group, the quality of life in the observation group was significantly improved, and the incidence of adverse reactions was reduced.
Conclusion


Chinese herbal decoction combined with psychological care can improve the clinical symptoms, alleviate the toxic and side effects, and improve the life quality of EC patients with postoperative chemotherapy.",2022,"In addition, CD3+ and CD4+ levels in the observation group were higher than those in the control group.","['EC patients with postoperative chemotherapy', 'Postoperative Chemotherapy Patients with Endometrial Cancer', '80 EC patients with postoperative chemotherapy']","['psychotherapy', 'Psychological Care and Chinese Herbal Decoction', 'psychological care and Chinese herbal decoction', 'psychological care plus Chinese herbal decoction treatment']","['HE4, CA125, traditional Chinese medicine (TCM) syndrome scores, toxic and side effects, and quality of life scores', 'total effective rate', 'incidence of adverse reactions', 'CD3+ and CD4+ levels', 'serum HE4 and CA125 levels', 'life quality', 'quality of life', 'CD8+ level']","[{'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0903042', 'cui_str': 'Human epididymis protein 4'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}]",80.0,0.0362543,"In addition, CD3+ and CD4+ levels in the observation group were higher than those in the control group.","[{'ForeName': 'Jinjie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Medical Insurance Department, Zhangqiu District People's Hospital, Jinan 250200, Shandong Province, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Clinical Laboratory, Zhangqiu District People's Hospital, Jinan 250200, Shandong Province, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Gynaecology, Renzheng Hospital, Renzheng 265811, Shandong Province, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'PIVAS, Yantaishan Hospital, Yantai 264001, Shandong Province, China.'}]",Journal of healthcare engineering,['10.1155/2022/5700637']
2705,35222879,Effect of Nursing Method of Psychological Intervention Combined with Health Education on Lung Cancer Patients Undergoing Chemotherapy.,"At present, lung cancer has become clinically the malignant tumor with the highest incidence and mortality rate in China. Smoking, environmental pollution, infection, etc., are closely related to lung cancer. To investigate the effect of the nursing method of psychological intervention combined with health education on lung cancer patients undergoing chemotherapy, 70 lung cancer patients who received chemotherapy in our hospital from June 2017 to June 2020 were selected and randomly divided into a routine intervention group ( n  = 35) and a combined intervention group ( n  = 35). Patients in the two groups had the same chemotherapy method and medication. The routine intervention group received the routine nursing intervention, while on this basis, the combined intervention group received psychological intervention combined with health education. After 6-week nursing, self-rating anxiety scale (SAS) score, self-rating depression scale (SDS) score, cancer pain score before and after nursing, improvement of respiratory function before and after nursing, sleep quality score, quality of life score, and nursing satisfaction were analyzed. Through nursing intervention, the quality of life indexes such as physiological, physical, social, emotional, and other indexes in the combined intervention group were significantly better than those in the routine intervention group, with statistical differences ( P  < 0.01). The nursing satisfaction in the combined intervention group was significantly better than that in the routine intervention group, with statistical significance ( χ   2  = 8.9342,  P  < 0.05). The psychological intervention combined with health education for lung cancer patients undergoing chemotherapy can effectively alleviate anxiety and depression, increase confidence in treatment, reduce pain and significantly improve sleep quality, respiratory function, quality of life, and nursing satisfaction.",2022,"The nursing satisfaction in the combined intervention group was significantly better than that in the routine intervention group, with statistical significance ( χ   2  = 8.9342,  P  < 0.05).","['lung cancer patients undergoing', 'Lung Cancer Patients Undergoing Chemotherapy', 'lung cancer patients undergoing chemotherapy, 70 lung cancer patients who received chemotherapy in our hospital from June 2017 to June 2020']","['nursing method of psychological intervention combined with health education', 'psychological intervention combined with health education', 'routine intervention group ( n \u2009=\u200935) and a combined intervention group', 'routine nursing intervention', 'Nursing Method of Psychological Intervention Combined with Health Education', 'chemotherapy']","['sleep quality, respiratory function, quality of life, and nursing satisfaction', 'nursing satisfaction', 'self-rating anxiety scale (SAS) score, self-rating depression scale (SDS) score, cancer pain score before and after nursing, improvement of respiratory function before and after nursing, sleep quality score, quality of life score, and nursing satisfaction', 'quality of life indexes such as physiological, physical, social, emotional']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",,0.0120626,"The nursing satisfaction in the combined intervention group was significantly better than that in the routine intervention group, with statistical significance ( χ   2  = 8.9342,  P  < 0.05).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Internal Medicine-Oncology,Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430034, Hubei Province, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Internal Medicine-Oncology,Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430034, Hubei Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Internal Medicine-Oncology,Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430034, Hubei Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Internal Medicine-Oncology,Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430034, Hubei Province, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Internal Medicine-Oncology,Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430034, Hubei Province, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Internal Medicine-Oncology,Wuhan Fourth Hospital, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430034, Hubei Province, China.'}]",Journal of healthcare engineering,['10.1155/2022/2438612']
2706,35222869,The Use of Cryotherapy in Conjunction with Surgical Removal of Mandibular Third Molars: a Single-Blinded Randomized Controlled Trial.,"Objectives


Cryotherapy is frequently used to diminish postoperative sequelae following mandibular third molar surgery. The objective of this single-blinded randomized controlled trial was to assess the therapeutic efficiency of 30 minutes continuous cryotherapy on postoperative sequelae following surgical removal of mandibular third molars compared with no cryotherapy.
Material and Methods


Thirty patients (14 male and 16 female) including 60 mandibular third molars were randomly allocated to 30 minutes of immediately cryotherapy or no cryotherapy. Outcome measures included pain (visual analogue scale score), maximum mouth opening (trismus) and quality of life (oral health impact profile-14). Outcome measures were assessed preoperatively and one day, three days, seven days and one month following surgical removal of mandibular third molars. Descriptive and generalized estimating equation analyses were made. Level of significance was 0.05.
Results


No cryotherapy following surgical removal of mandibular third molars revealed a statistically significant lower visual analogue scale score of pain compared to thirty minutes of continuous cryotherapy after one day (P < 0.05). However, no statistically significant difference in trismus or oral health-related quality of life were revealed at any time point compared with no cryotherapy.
Conclusions


The therapeutic effect of 30 minutes continuous cryotherapy following surgical removal of mandibular third molars seem to be negligible. Thus, further randomized controlled trials assessing a prolonged application period of cryotherapy, alternative devices or use of intermittent cryotherapy are needed before definite conclusions and evidence-based clinical recommendations can be provided.",2021,"However, no statistically significant difference in trismus or oral health-related quality of life were revealed at any time point compared with no cryotherapy.
","['mandibular third molar surgery', 'Thirty patients (14 male and 16 female) including 60 mandibular third molars']","['Cryotherapy', 'immediately cryotherapy or no cryotherapy', '30 minutes continuous cryotherapy']","['therapeutic efficiency', 'postoperative sequelae', 'pain (visual analogue scale score), maximum mouth opening (trismus) and quality of life (oral health impact profile-14', 'surgical removal of mandibular third molars', 'visual analogue scale score of pain', 'trismus or oral health-related quality of life']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0607181,"However, no statistically significant difference in trismus or oral health-related quality of life were revealed at any time point compared with no cryotherapy.
","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Kjærgaard Larsen', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Aalborg University HospitalDenmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kofod', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Copenhagen University Hospital, RigshospitaletDenmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Starch-Jensen', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Aalborg University HospitalDenmark.'}]",Journal of oral & maxillofacial research,['10.5037/jomr.2021.12402']
2707,35223140,Can Video Gameplay Improve Undergraduates' Problem-Solving Skills?,"In this study, the authors investigated if two distinct types of video gameplay improved undergraduates' problem-solving skills. Two groups of student participants were recruited to play either a roleplaying video game (World of Warcraft; experimental group) or a brain-training video game (CogniFit; control group). Participants were measured on their problem-solving skills before and after 20 hours of video gameplay. Two measures were used to assess problem-solving skills for this study, the Tower of Hanoi and The PISA Problem Solving Test. The Tower of Hanoi measured the rule application component of problem-solving skills and the PISA Problem Solving test measured transfer of problem-solving skills from video gameplay to novel scenarios on the test. No significant differences were found between the two groups on either problem-solving measure. Implications for future studies on game- based learning are discussed.",2020,No significant differences were found between the two groups on either problem-solving measure.,['Two groups of student participants were recruited to play either a'],['roleplaying video game (World of Warcraft; experimental group) or a brain-training video game (CogniFit; control group'],"[""undergraduates' problem-solving skills""]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033211', 'cui_str': 'Problem solving'}]",,0.0342779,No significant differences were found between the two groups on either problem-solving measure.,"[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Emihovich', 'Affiliation': 'University of Michigan - Flint, Flint, USA.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Roque', 'Affiliation': 'Pennsylvania State University, State College, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'University of Florida, Gainesville, USA.'}]",International journal of game-based learning,['10.4018/ijgbl.2020040102']
2708,35223111,Gonadotoxic effect of tramadol administration: A prospective controlled study.,"Objective


To detect the possible gonadotoxic effects of tramadol dependence on seminal fluid parameters, and prolactin and testosterone hormone levels.
Patients Subjects and Methods


There were 94 participants who were divided into a tramadol-dependent group (T-group; 56 patients) and a control group (C-group; 38 healthy volunteers). The following variables were evaluated: testosterone level, prolactin level, erectile function, libido, semen parameters, and effect of tramadol dose and dependence duration.
Results


There was a significant increase in erectile dysfunction (ED) and decreased libido in the T-group vs C-group. Also, the serum testosterone level was lower in the T-group vs the C-group, while the serum prolactin level was significantly higher in the T-group vs the C-group. All semen parameters were low in the T-group except for abnormal forms, which were high. As the dose of tramadol increased there was a more negative effect on the previous parameter, while ED, libido, semen volume and concentration showed no significant changes. When comparing tramadol doses of 400-1000 mg/day to >1000 mg/day, the tramadol blood level increased with high doses, while serum testosterone level decreased when the dose increased and the prolactin level increased when the dose increased. Progressive motility of the sperm decreased and abnormal forms increased. Also increased duration of tramadol administration was also accompanied by a more negative effect on these parameters.
Conclusion


Tramadol administration has a negative effect on hormone levels, libido, erectile function, and semen characters. Abbreviations:  ED: erectile dysfunction; EF: erectile function.",2022,There was a significant increase in erectile dysfunction (ED) and decreased libido in the T-group vs C-group.,['Patients Subjects and Methods\n\n\nThere were 94 participants who were divided into a tramadol-dependent group (T-group; 56 patients) and a control group (C-group; 38 healthy volunteers'],"['tramadol dependence', 'Tramadol', 'tramadol']","['prolactin level', 'Progressive motility', 'hormone levels, libido, erectile function, and semen characters', 'testosterone level, prolactin level, erectile function, libido, semen parameters, and effect of tramadol dose and dependence duration', 'duration of tramadol administration', 'Gonadotoxic effect', 'tramadol blood level', 'serum prolactin level', 'serum testosterone level', 'erectile dysfunction (ED) and decreased libido', 'seminal fluid parameters, and prolactin and testosterone hormone levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}]","[{'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1277972', 'cui_str': 'Serum prolactin measurement'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0036614', 'cui_str': 'Seminal fluid'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}]",38.0,0.0103833,There was a significant increase in erectile dysfunction (ED) and decreased libido in the T-group vs C-group.,"[{'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Soliman', 'Affiliation': 'Department of Urology and Andrology, Benha University, Benha, Egypt.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Shaher', 'Affiliation': 'Department of Urology and Andrology, Benha University, Benha, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Mohey', 'Affiliation': 'Department of Urology and Andrology, Benha University, Benha, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'El-Shaer', 'Affiliation': 'Department of Urology and Andrology, Benha University, Benha, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Sebaey', 'Affiliation': 'Department of Urology and Andrology, Benha University, Benha, Egypt.'}]",Arab journal of urology,['10.1080/2090598X.2021.2002634']
2709,35223110,Short- and long-term follow-up results of daily 5-mg tadalafil as a treatment for erectile dysfunction and premature ejaculation.,"Objective


To evaluate the safety and effectiveness of daily 5-mg tadalafil treatment for men who have erectile dysfunction (ED) and premature ejaculation (PE), and to assess the long-term follow-up for ED and PE improvement persistence years after the cessation of medication.
Patients and Methods


A prospective, single-blind, randomised study included 160 patients with ED and PE. All were evaluated using the International Index of Erectile Function (IIEF-5) questionnaire to evaluate ED and intravaginal ejaculatory latency time (IELT) for PE. Patients were subdivided into two equal groups. Group I (80 patients) treated with daily 5-mg tadalafil for 3 months, and Group II (80 patients) treated with a placebo for the same period. After 3 months of treatment and 2 years later after cessation of tadalafil, all patients were assessed for ED and PE.
Results


The mean (SD) IELT and IIEF-5 score pre-treatment were 37 (11.24) s and 13.2 (4.2) for Group I, while in Group II they were 35.98 (10.8) s and 13.12 (4.11), respectively. After 3 months of treatment, the mean (SD) IELT in Group I showed a highly significant improvement from 37 (11.24) s to 120.5 (47.37) s ( P  < 0.001) but Group II showed no significant improvement from baseline to [39.43 (13.6) s;  P  > 0.05]. For the IIEF-5 score, there was a highly significant improvement from baseline to 20.45 (4.5) in Group I ( P  < 0.001), while there was no significant difference in Group II from baseline to [15 (4.84);  P  > 0.05]. At 2 years after cessation of tadalafil, there was statistically significant improvement in the IELT and IIEF-5 from baseline to endpoint .
Conclusion


Oral daily 5-mg tadalafil was effective, tolerable, and safe treatment for patients with ED and PE. Long-term follow-up at 2 years confirmed the persistence of a significant improvement for both ED and PE. Abbreviations : ED: erectile dysfunction; IIEF-5: five-item version of the International Index of Erectile Function questionnaire; IELT: intravaginal ejaculatory latency time; OAD: once-daily; PDE5i: phosphodiesterase-5 inhibitors; PE: premature ejaculation; PRN:  pro re nata .",2022,erectile dysfunction; IIEF-5: five-item version of the International Index of Erectile Function questionnaire; IELT: intravaginal ejaculatory latency time; OAD: once-daily; PDE5i: phosphodiesterase-5 inhibitors; PE: premature ejaculation; PRN:  pro re nata .,"['patients with ED and PE', 'men who have erectile dysfunction (ED) and premature ejaculation (PE', '160 patients with ED and PE']","['tadalafil', 'placebo', 'daily 5-mg tadalafil']","['effective, tolerable, and safe treatment', 'safety and effectiveness', 'IELT and IIEF-5', 'IIEF-5 score', 'mean (SD) IELT and IIEF-5 score pre-treatment', 'International Index of Erectile Function (IIEF-5) questionnaire to evaluate ED and intravaginal ejaculatory latency time (IELT) for PE', 'erectile dysfunction and premature ejaculation', 'ED and PE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}]",160.0,0.0386967,erectile dysfunction; IIEF-5: five-item version of the International Index of Erectile Function questionnaire; IELT: intravaginal ejaculatory latency time; OAD: once-daily; PDE5i: phosphodiesterase-5 inhibitors; PE: premature ejaculation; PRN:  pro re nata .,"[{'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Mohamed Gharib', 'Affiliation': 'Urology Department, Faculty of Medicine Benha University, Benha, Egypt.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abdel-Al', 'Affiliation': 'Urology Department, Faculty of Medicine, Al-Azhar University, Assiut Branch, Egypt.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Elatreisy', 'Affiliation': 'Urology Department, Faculty of medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Kandeel', 'Affiliation': 'Urology Department, Faculty of Medicine Benha University, Benha, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'El-Shaer', 'Affiliation': 'Urology Department, Faculty of Medicine Benha University, Benha, Egypt.'}, {'ForeName': 'Abdrabuh M', 'Initials': 'AM', 'LastName': 'Abdrabuh', 'Affiliation': 'Urology Department, Faculty of medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Elsayed', 'Initials': 'E', 'LastName': 'Mohamed Salih', 'Affiliation': 'Urology Department, Faculty of medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Sebaey', 'Affiliation': 'Urology Department, Faculty of Medicine Benha University, Benha, Egypt.'}]",Arab journal of urology,['10.1080/2090598X.2021.2024695']
2710,35223109,Grooved vs smooth ureteric stent before extracorporeal shockwave lithotripsy: Single-blind randomised clinical trial.,"Objective


No study compared the grooved stent to the widely used standard smooth (non-grooved) stent in humans. We compared stone clearance, complications, and patient tolerance of the grooved stent vs standard JJ stent.
Patients and Methods


Single-blinded randomised trial among patients planned for pre-extracorporeal shockwave lithotripsy (ESWL) stenting. Adult patients with unilateral ureteric/renal stones planned for ESWL were randomly assigned to receive (Percuflex) smooth ureteric stent or (Visiostar) grooved lithotripsy stent and blinded to the stent type. We collected and compared the baseline data and outcomes (stone-free rate, complications, and stent-related symptoms) of both patient groups.
Results


A total of 96 adults were included (48 per arm). There were no significant differences between the groups at baseline in terms of demographics, body mass index, comorbidities, renal function, number of ESWL sessions, and stone characteristics, including pre-ESWL stone volume (mean [SD] smooth 310.2 [301.6] vs grooved 270.7 [278.6] mm3, P = 0.5). Stone clearance was statistically insignificant between the groups, although clinically relevant (smooth stent 70.8% vs grooved stent 81.2%, P = 0.2). Grooved-stent patients reported comparable urinary symptoms score ( P =  0.05) and operative complications ( P =  0.6), but significantly more urinary tract infections (UTIs) not requiring hospitalisation ( P =  0.003).
Conclusions


Although statistically insignificant, the grooved stent exhibited higher stone clearance compared to the smooth stent, with similar complication rates excpet that patients with grooved stents reported more UTIs. A re-visit to the size of the outer diameter of the grooved stent could enhance its stone clearance properties, and further development of its coating material could lead to better patient satisfaction.",2022,"There were no significant differences between the groups at baseline in terms of demographics, body mass index, comorbidities, renal function, number of ESWL sessions, and stone characteristics, including pre-ESWL stone volume (mean [SD] smooth 310.2 [301.6] vs grooved 270.7 [278.6] mm3, P = 0.5).","['Adult patients with unilateral ureteric/renal stones planned for ESWL', 'A total of 96 adults were included (48 per arm']","['extracorporeal shockwave lithotripsy', 'receive (Percuflex) smooth ureteric stent or (Visiostar) grooved lithotripsy stent and blinded to the stent type', 'extracorporeal shockwave lithotripsy (ESWL) stenting']","['stone clearance', 'urinary symptoms score', 'urinary tract infections (UTIs) not requiring hospitalisation', 'Stone clearance', 'operative complications', 'demographics, body mass index, comorbidities, renal function, number of ESWL sessions, and stone characteristics, including pre-ESWL stone volume', 'stone clearance, complications, and patient tolerance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",96.0,0.306522,"There were no significant differences between the groups at baseline in terms of demographics, body mass index, comorbidities, renal function, number of ESWL sessions, and stone characteristics, including pre-ESWL stone volume (mean [SD] smooth 310.2 [301.6] vs grooved 270.7 [278.6] mm3, P = 0.5).","[{'ForeName': 'Abdulqadir', 'Initials': 'A', 'LastName': 'Alobaidy', 'Affiliation': 'Department of Surgery, Urology Section, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Surgery, Urology Section, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'El Ansari', 'Affiliation': 'Department of Surgery, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Hosam', 'Initials': 'H', 'LastName': 'Tawfik', 'Affiliation': 'Department of Surgery, Urology Section, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Al-Naimi', 'Affiliation': 'Department of Surgery, Urology Section, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Salam', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Department of Surgery, Urology Section, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Al-Ansari', 'Affiliation': 'Department of Surgery, Urology Section, Hamad Medical Corporation, Doha, Qatar.'}]",Arab journal of urology,['10.1080/2090598X.2021.2004502']
2711,35223519,Potential Influence of Anesthetic Interventions on Breast Cancer Early Recurrence According to Estrogen Receptor Expression: A Sub-Study of a Randomized Trial.,"Background


Effects of anesthetic interventions on cancer prognosis remain controversial. There is evidence that estrogen receptor (ER)-negative breast cancer patients have an early recurrence peak. We aimed to assess the potential benefit of regional anesthesia-analgesia versus general anesthesia regarding early recurrence in breast cancer according to ER expression.
Methods


Based on a multicenter randomized controlled trial (clinicaltrials.gov, NCT00418457), we included all the patients from Peking Union Medical College Hospital research center in this study. The primary outcome was breast cancer recurrence after surgery. The Cox proportional hazard model was used to compare recurrence between groups.
Results


In total, 1,253 breast cancer patients were included in this sub-study, among whom the median follow-up time was 53 months. In this sub-study, 320 patients were ER-negative, and 933 were ER-positive. As for ER-negative patients, the recurrence risk in the PPA (paravertebral blocks and propofol general anesthesia) group showed no statistical difference compared with the GA (sevoflurane and opioids general anesthesia) group (19.1% versus 23.4%; adjusted HR: 0.80, 95% CI: 0.50-1.30;  P  = 0.377). In the first 18 months after breast cancer surgery, which is considered as the classical early peak of recurrence, after adjustment for menstruation and the pathological stage of tumor, the decrease of early recurrence observed in the PPA group was not significant compared with the GA group (adjusted HR: 0.63, 95% CI: 0.34-1.14;  P  = 0.127).
Conclusions


In our study, the effects of early recurrence after breast cancer surgery in both ER-negative and ER-positive patients were similar between regional anesthesia-analgesia and general anesthesia. Large samples of ER-negative patients will be needed to clarify the effects of anesthetic interventions.",2022,"As for ER-negative patients, the recurrence risk in the PPA (paravertebral blocks and propofol general anesthesia) group showed no statistical difference compared with the GA (sevoflurane and opioids general anesthesia) group (19.1% versus 23.4%; adjusted HR: 0.80, 95% CI: 0.50-1.30;  P  = 0.377).","['1,253 breast cancer patients', 'patients from Peking Union Medical College Hospital research center in this study', 'Breast Cancer Early Recurrence', '320 patients were ER-negative, and 933 were ER-positive']","['anesthetic interventions', 'Anesthetic Interventions', 'GA (sevoflurane', 'regional anesthesia-analgesia versus general anesthesia']","['early recurrence', 'recurrence risk', 'breast cancer recurrence']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C5191368', 'cui_str': '933'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",1253.0,0.239454,"As for ER-negative patients, the recurrence risk in the PPA (paravertebral blocks and propofol general anesthesia) group showed no statistical difference compared with the GA (sevoflurane and opioids general anesthesia) group (19.1% versus 23.4%; adjusted HR: 0.80, 95% CI: 0.50-1.30;  P  = 0.377).","[{'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuelun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Medical Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lijian', 'Initials': 'L', 'LastName': 'Pei', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Tan', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}]",Frontiers in oncology,['10.3389/fonc.2022.837959']
2712,35223393,The effect of melatonin on quality of sleep in patients with sleep disturbance admitted to post coronary care units: A randomized controlled trial.,"Background and objectives


Patients with cardiovascular disease who required to be admitted in coronary care units (CCU) would have sleep deprivation. During the admission some factors such as continuous ambient light exposure can suppress melatonin release, in consequence sleep deprivation will be occurred and hinder the progress of patients' treatment. The aim of study was to evaluate the effect of melatonin on the sleep quality of patients admitted to post-CCU.
Materials and methods


This randomized clinical trial was carried out on 110 patients admitted to post-CCU at SayyadeShirazi Hospital, Gorgan, Iran. Patients with a poor sleep quality (Pittsburgh sleep quality index (PSQI) global score>5) were randomly allocated into two intervention and placebo groups. Patients in the intervention group received melatonin (3 mg; 30 minutes before bedtime), and the placebo group received placebo for 2 weeks, and their sleep quality was re-evaluated after the end of intervention. Data were analyzed using paired  t  test, Wilcoxon, and Chi-square tests by SPSS version 21.
Results


The results showed that mean of the patients' PSQI scores decreased significantly in intervention group (from 14.95 ± 1.48 to 11.65 ± 1.50, P < 0.001), while in placebo group the difference was not significant (from 15.48 ± 1.47 to 15.24 ± 1.71, P = 0.129). Post-intervention score of patients in intervention group was also lower than the placebo group (P < 0.001).
Conclusion


The melatonin can improve the sleep quality of the patients admitted to post-CCU who suffer from sleep disturbance.",2021,"Post-intervention score of patients in intervention group was also lower than the placebo group (P < 0.001).
","['110 patients admitted to post-CCU at SayyadeShirazi Hospital, Gorgan, Iran', 'patients with sleep disturbance admitted to post coronary care units', 'patients admitted to post-CCU', 'Patients with cardiovascular disease who required to be admitted in coronary care units (CCU) would have sleep deprivation', 'patients admitted to post-CCU who suffer from sleep disturbance', 'Patients with a poor sleep quality (Pittsburgh sleep quality index (PSQI) global score>5']","['melatonin', 'placebo']","['sleep quality', 'PSQI scores', 'quality of sleep']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0010066', 'cui_str': 'Coronary Care Units'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",110.0,0.108997,"Post-intervention score of patients in intervention group was also lower than the placebo group (P < 0.001).
","[{'ForeName': 'Mohammad Zaman', 'Initials': 'MZ', 'LastName': 'Kamkar', 'Affiliation': 'Department of Psychiatry, Golestan Research Center of Psychiatry, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Mahyar', 'Affiliation': 'Department of Psychiatry, School of Medicine, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Seyedmahrokh A', 'Initials': 'SA', 'LastName': 'Maddah', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Khoddam', 'Affiliation': 'Nursing Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Modanloo', 'Affiliation': 'Nursing Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}]",BioMedicine,['10.37796/2211-8039.1123']
2713,35223304,Chronic Low Back Pain Forced Me to Search for and Find Pain Solutions: An Autobiographical Case Report.,"Lifelong, pregnancy-induced low back pain forced me to search for solutions to the problem of pain. Currently, low back pain is often diagnosed as ""nonspecific"" and, as a result, a multitude of tests and poorly effective, at times side effect-laden or habit-forming treatments are recommended. My quest for relief took me to first diagnose my pain as coming from the sacroiliac joints, then to prolotherapy, the first treatment which brought me prolonged relief. I then learned how to perform prolotherapy. In 2009, when I undertook a randomized controlled study of dextrose prolotherapy for rotator cuff tendinopathy, I restricted my practice to treating pain. As low back pain was a large part of my practice, I sought new ways to examine the sacroiliac joints. I conducted a consecutive patient data collection which suggested that over three-quarters of those with low back pain suffer from displaced sacroiliac joints. In a further randomized controlled study, I found that the two-minute corrective exercise I derived from this test provided immediate relief to 90% of those using it. With Dr. John Clark Lyftogt I discovered the safety and effectiveness of 5% dextrose perineural injections to provide immediate pain relief to any area supplied by a nerve I could reach with my needle. As I was treating many diabetics with peripheral neuropathy, I shifted my perineural injection material to 5% mannitol, which may be as effective, with less exposure to dextrose as a potential benefit for diabetics. As most people dislike injections, a pharmacist and I developed a mannitol-containing topical cream for pain relief. We compared a base cream to the same cream with mannitol on lips pretreated with capsaicin cream which made them burn. By 10 minutes the probability the two creams were as effective in relieving the burn was less than 0.001 in favor of mannitol. When given to 235 patients with a total of 289 different painful conditions, we found that it provided 53% relief in an average of 16 minutes with a median of four hours duration. Now retired, after 55 years of medical practice, I love to relieve the pain of friends and fellow hikers using exercise and cream. Searching for and finding solutions to chronic pain has enriched my life and that of many others.",2022,By 10 minutes the probability the two creams were as effective in relieving the burn was less than 0.001 in favor of mannitol.,"['rotator cuff tendinopathy, I\xa0restricted my practice to treating pain', '235 patients with a total of 289 different painful conditions', 'diabetics with peripheral neuropathy']","['dextrose prolotherapy', 'mannitol-containing topical cream', 'capsaicin cream']","['safety and effectiveness', 'pain relief', 'effective in relieving the burn']","[{'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0500223', 'cui_str': 'Prolotherapy'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0991551', 'cui_str': 'Cutaneous cream'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}]",235.0,0.0446126,By 10 minutes the probability the two creams were as effective in relieving the burn was less than 0.001 in favor of mannitol.,"[{'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Bertrand', 'Affiliation': 'Department of Family Practice, University of British Columbia, North Vancouver, CAN.'}]",Cureus,['10.7759/cureus.21529']
2714,35223758,Azhe'é Bidziil (Strong Fathers): Study Protocol for the Pilot Evaluation of an American Indian Fatherhood Program to Improve the Health and Wellbeing of Diné (Navajo) Fathers.,"Introduction


Considering the critical role that American Indian and Alaska Native (Native) men play in family and child health, there is an urgent need to collaborate with Native communities in developing interventions and policies to improve Native men's health status. This study aims to address a significant gap in research by designing and implementing a culturally grounded health promotion program to increase economic stability, promote positive parenting, and build healthy relationships among Native fathers. The Azhe'é Bidziil (""Strong Fathers"") study protocol, developed in response to community advisory board feedback, illustrates a community-engaged approach to developing and implementing a fatherhood program in two Diné (Navajo) communities.
Methods/Analysis


Azhe'é Bidziil was adapted from three evidence-based interventions developed in collaboration with Native communities. Intervention lessons were iteratively reviewed by a tribal working group to ensure that the content is culturally appropriate and relevant. A pre-post study will assess feasibility, acceptability, and satisfaction with the Azhe'é Bidziil intervention, as well as short-term impacts on positive parenting, economic stability, and healthy relationship outcomes. The intervention is composed of 12 weekly group sessions conducted with fathers ( n  = 750) that focus on developing knowledge and skills for positive father involvement, economic stability, and healthy relationships. Lesson content includes: honoring our roles as fathers, building healthy relationships, understanding the impact of historical trauma, goal-setting, and budgeting basics. Each of the 12 group lessons, consisting of 8-12 participants per group, last approximately 2 h. Eligible fathers or father figures are age ≥18 years, live within 50 miles of the participating Diné communities, and must be caregivers of at least one child ≤ 24 years. The outcomes for this study are acceptability, feasibility, and satisfaction with the intervention, as well as father involvement, quality of (co-) parenting communication, healthy relationships, fathers' engagement and communication with their children, protective factors (e.g., cultural connectedness and educational/career aspirations), and economic empowerment and stability. Participants will complete an outcome assessment at pre- and post-intervention (12 weeks later).
Discussion


This study protocol presents one of the few evaluations of a fatherhood intervention to increase economic stability, promote positive parenting, and build healthy relationships among Native fathers in rural tribal communities. Such a study is sorely needed to address the health disparities perpetuated by social and Indigenous determinants of health that Native men experience today. If proven efficacious, this pre- post-study will inform a large scale randomized controlled trial to evaluate intervention impact, and if proven efficacious may be disseminated widely in tribal nations. Study findings may also deepen our understanding of peer mentoring, Native men's health status, involvement with their children, co-parenting relationships, family relationships, cultural connectedness, and economic status. The data collected may also inform strategies to ensure acceptability, feasibility, and satisfaction of an intervention designed specifically for Native fathers.",2021,"The data collected may also inform strategies to ensure acceptability, feasibility, and satisfaction of an intervention designed specifically for Native fathers.","['12 group lessons, consisting of 8-12 participants per group, last approximately 2 h. Eligible fathers or father figures are age ≥18 years, live within 50 miles of the participating Diné communities, and must be caregivers of at least one child ≤ 24 years', 'Native fathers in rural tribal communities', 'American Indian and Alaska Native (Native) men play in family and child health', 'Native fathers', ""Azhe'é Bidziil (Strong Fathers""]","['fatherhood intervention', 'American Indian Fatherhood Program', ""Azhe'é Bidziil intervention""]","['positive parenting, economic stability, and healthy relationship outcomes', 'Health and Wellbeing of Diné (Navajo) Fathers', 'feasibility, acceptability, and satisfaction', ""acceptability, feasibility, and satisfaction with the intervention, as well as father involvement, quality of (co-) parenting communication, healthy relationships, fathers' engagement and communication with their children, protective factors (e.g., cultural connectedness and educational/career aspirations), and economic empowerment and stability""]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0331865', 'cui_str': 'miles'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]","[{'cui': 'C0337499', 'cui_str': 'Fatherhood'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2001048', 'cui_str': '(tris(2-aminoethyl)amine)(aminoacetone)cobalt(III)'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]",,0.0333362,"The data collected may also inform strategies to ensure acceptability, feasibility, and satisfaction of an intervention designed specifically for Native fathers.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Richards', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Tiffani', 'Initials': 'T', 'LastName': 'Begay', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Chambers', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Hima', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Mayhew', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Joshuaa', 'Initials': 'J', 'LastName': 'Allison-Burbank', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'LeDaniel', 'Initials': 'L', 'LastName': 'Gishie', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Nolan', 'Initials': 'N', 'LastName': 'Tsingine', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Badoni', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Leander', 'Initials': 'L', 'LastName': 'Staley', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Bradlin', 'Initials': 'B', 'LastName': 'Harvey', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Tsosie', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Begay', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mitchell', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Tingey', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States.'}]",Frontiers in public health,['10.3389/fpubh.2021.790024']
2715,35223561,"Changes in Matrix Metalloproteinase-8, Interleukin-6 and Tumor Necrosis Factor-A in Gingival Crevicular Fluid during Rapid Maxillary Expansion in Adolescent Patients.","Background


Rapid maxillary expansion (RME) is the standard treatment for correcting lateral maxillary defects commonly used in orthodontics. It is the most effective approach to increase maxillary width in clinical practice. At present, there are few studies on the level of molecular biology of periodontal tissue remodeling during RME. We aimed to investigate changes in matrix metalloproteinase (MMP)-8, interleukin (IL)-6 and tumor necrosis factor (TNF)-αin gingival crevicular fluid during RME.
Methods


Patients admitted to Department of Stomatology, the Third Affiliated Hospital of Qiqihar Medical University, Qiqihar, Heilongjiang Province, China between Dec 2016 and Dec 2018 were enrolled, and randomly divided into the observation group (76 cases) and control group (62 cases). Periodontal clinical indicators were recorded. Gingival crevicular fluid was collected and the periodontal clinical indicators were recorded. The levels of MMP-8, IL-6 and TNF-α were determined by ELISA, and the contents of the two groups were compared.
Results


The plaque index of the observation group was significantly higher than that of the baseline T0 ( P < 0.05) from T4, and the increase in the control group started from T5. The general clinical data of the two groups showed that the white blood cell count of the observation group was higher than that of the control group. The levels of MMP-8, IL-6 and TNF-α were the highest at T2, followed by T3, and gradually decreased at T4, and T5, and the differences were significant ( P <0.05).
Conclusion


The changes in levels of MMP-8, IL-6 and TNF-α in adolescent patients during RME were related to the remodeling of periodontal tissue after RME.",2021,"The plaque index of the observation group was significantly higher than that of the baseline T0 ( P < 0.05) from T4, and the increase in the control group started from T5.","['Adolescent Patients', 'Methods\n\n\nPatients admitted to Department of Stomatology, the Third Affiliated Hospital of Qiqihar Medical University, Qiqihar, Heilongjiang Province, China between Dec 2016 and Dec 2018 were enrolled', 'adolescent patients during RME']",['\n\n\nRapid maxillary expansion (RME'],"['Gingival crevicular fluid', 'matrix metalloproteinase (MMP)-8, interleukin (IL)-6 and tumor necrosis factor (TNF)-αin gingival crevicular fluid', 'plaque index', 'white blood cell count', 'levels of MMP-8, IL-6 and TNF-α']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0029167', 'cui_str': 'Medicine, Oral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}]","[{'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0172956', 'cui_str': 'Neutrophil collagenase'}]",,0.0735862,"The plaque index of the observation group was significantly higher than that of the baseline T0 ( P < 0.05) from T4, and the increase in the control group started from T5.","[{'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'Department of Stomatology, the Third Affiliated Hospital of Qiqihar Medical University, Qiqihar 161000, Heilongjiang Province, China.'}, {'ForeName': 'Dongxue', 'Initials': 'D', 'LastName': 'Mi', 'Affiliation': 'Department of Gastroenterology, Qiqihar Jianhua Hospital, Qiqihar161000, Heilongjiang Province, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Stomatology, Qiqihar First Hospital, Qiqihar161000, Heilongjiang Province, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Department of Stomatology, the Third Affiliated Hospital of Qiqihar Medical University, Qiqihar 161000, Heilongjiang Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Stomatology, the Third Affiliated Hospital of Qiqihar Medical University, Qiqihar 161000, Heilongjiang Province, China.'}, {'ForeName': 'Xuelin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Stomatology, the Third Affiliated Hospital of Qiqihar Medical University, Qiqihar 161000, Heilongjiang Province, China.'}, {'ForeName': 'Yujia', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Endocrinology, the Third Affiliated Hospital of Qiqihar Medical University, Qiqihar 161000, Heilongjiang Province, China.'}, {'ForeName': 'Weikun', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Basic Medical Science College, Qiqihar Medical University, Qiqihar 161000, Heilongjiang Province, China.'}]",Iranian journal of public health,['10.18502/ijph.v50i10.7494']
2716,35223980,Analysis of the Guiding Role of CYP2C19 Gene Combined With Platelet Function Detection in Antiplatelet Therapy in Patients With Complex Coronary Artery Disease After PCI.,"Objective


To explore the influence of CYP2C19 gene combined with platelet function test on clinical prognosis of patients with complex coronary artery disease receiving antiplatelet therapy after PCI.
Methods


A total of 200 patients undergoing PCI in our hospital due to complex coronary artery disease from February 2019 to February 2021 were selected and divided into the control group and the observation group according to whether CYP2C19 gene detection was performed. The control group was treated with dual antiplatelet therapy of classical aspirin combined with clopidogrel, and the observation group was treated with individual antiplatelet therapy. The patients in the two groups were followed up for 1 year after PCI, and their quality of life was assessed using the Seattle Angina Questionnaire (SAQ score). The occurrence of major adverse cardiovascular events (MACE) during the follow-up period was also recorded.
Results


The incidence of total MACE events in the observation group was slightly less than that in the control group, and the difference was statistically significant ( P  = 0.040). In particular, the observation group was superior to the control group in reducing the readmission rate of recurrent unstable angina pectoris, and the difference was statistically significant ( P  = 0.023). The location of coronary culprit lesions with recurrent ischemic events was commonly seen in non-interventional target lesions (interventional/non-interventional target sites: 12.9%: 77.1%). The SAQ score in the observation group was larger than that in the control group, and the difference was statistically significant ( P  = 0.012). There was no statistical difference in the incidence of major bleeding between the two groups ( P  = 0.352).
Conclusion


Using CYP2C19 genotype combined with platelet function test to guide individualized antiplatelet therapy after complex coronary artery PCI is beneficial to reducing ischemic events in a short period (1 year), mainly due to reducing the risk of readmission for recurrent unstable angina pectoris, and improving the quality of daily life of patients without increasing the risk of massive hemorrhage, which can improve clinical prognosis.",2022,"There was no statistical difference in the incidence of major bleeding between the two groups ( P  = 0.352).
","['Patients With Complex Coronary Artery Disease After PCI', 'patients with complex coronary artery disease receiving antiplatelet therapy after PCI', '200 patients undergoing PCI in our hospital due to complex coronary artery disease from February 2019 to February 2021']","['CYP2C19 gene combined with platelet function test', 'dual antiplatelet therapy of classical aspirin combined with clopidogrel, and the observation group was treated with individual antiplatelet therapy', 'CYP2C19 Gene']","['incidence of major bleeding', 'Seattle Angina Questionnaire (SAQ score', 'quality of life', 'occurrence of major adverse cardiovascular events (MACE', 'SAQ score', 'readmission rate of recurrent unstable angina pectoris', 'ischemic events', 'incidence of total MACE events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032184', 'cui_str': 'Platelet function test'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0050133', 'cui_str': '9,10-anthraquinone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",200.0,0.017394,"There was no statistical difference in the incidence of major bleeding between the two groups ( P  = 0.352).
","[{'ForeName': 'Jiancai', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, Teaching Hospital of Cangzhou Central Hospital of Tianjin Medical University, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yongxing', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Wanzhong', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'Department of Cardiology, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Junyan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Demin', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Zesheng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Teaching Hospital of Cangzhou Central Hospital of Tianjin Medical University, Tianjin Medical University, Tianjin, China.'}]",Frontiers in surgery,['10.3389/fsurg.2022.839157']
2717,35223959,Effect of Plant-Derived n-3 Polyunsaturated Fatty Acids on Blood Lipids and Gut Microbiota: A Double-Blind Randomized Controlled Trial.,"Background


Several cardioprotective mechanisms attributed to n-3 polyunsaturated fatty acids (PUFAs) have been widely documented. Significant interest has recently focused on the role of human gut microbiota in metabolic disorders. However, the role of plant-derived n-3 PUFAs on blood lipid profiles is controversial and the effect on gut microbiota is still unclear.
Objectives


We aimed to perform a double-blind randomized controlled trial to test the effect of plant-derived n-3 PUFAs on the blood lipids and gut microbiota of patients with marginal hyperlipidemia.
Methods


According to the inclusion and exclusion criteria, 75 participants with marginal hyperlipidemia were randomly assigned to the intervention group (supplied with n-3 PUFA-enriched plant oil) or control group (supplied with corn oil), respectively, for a 3-month treatment. Participants and assessors were blinded to the allocation. The primary outcomes of the trial were the changes in serum lipid levels. Secondary outcomes were changes in gut microbiota and metabolites. For the primary outcomes, we conducted both an intent-to-treat (ITT) analysis and a per protocol (PP) analysis. For the secondary outcomes, we only conducted the PP analysis among the participants who provided fecal sample.
Results


Fifty-one participants completed the trial. Relative to the control group, the n-3 PUFA supplementation resulted in significant reduction in total cholesterol (TC) levels (-0.43 mmol/L, 95% CI-0.84 to-0.01 mmol/L,  P  < 0.05). The n-3 PUFA supplementation was also associated with significantly increased relative abundance of  Bacteroidetes  in phylum level ( P  < 0.01; false discovery rate (FDR) corrected  p  = 0.11), and decreased the ratio between  Firmicutes  and  Bacteroidetes  ( P  < 0.05; FDR corrected  p  = 0.16). At genus level, the intervention of plant derived n-3 PUFAs resulted in a significant decrease in relative abundance of  Phascolarctobacterium  ( P  < 0.01; FDR corrected  p  = 0.18) and  Veillonella  ( P  < 0.01; FDR corrected  p  = 0.18) after the intervention.
Conclusions


Our results demonstrated that plant-derived n-3 PUFAs beneficially affected the serum levels of TC and decreased the ratio between  Firmicutes  and  Bacteroidetes  during the 12-week intervention period, which might confer advantageous consequences for lipid metabolism and intestinal health.",2022,"The n-3 PUFA supplementation was also associated with significantly increased relative abundance of  Bacteroidetes  in phylum level ( P  < 0.01; false discovery rate (FDR) corrected  p  = 0.11), and decreased the ratio between  Firmicutes  and  Bacteroidetes  ( P  < 0.05; FDR corrected  p  = 0.16).","['75 participants with marginal hyperlipidemia', 'patients with marginal hyperlipidemia']","['n-3 PUFA supplementation', 'intervention group (supplied with n-3 PUFA-enriched plant oil) or control group (supplied with corn oil', 'Plant-Derived n-3 Polyunsaturated Fatty Acids', 'plant-derived n-3 PUFAs']","['serum levels of TC', 'changes in gut microbiota and metabolites', 'relative abundance of  Phascolarctobacterium', 'total cholesterol (TC) levels', 'blood lipids and gut microbiota', 'Blood Lipids and Gut Microbiota', 'intent-to-treat (ITT) analysis and a per protocol (PP) analysis', 'serum lipid levels', 'relative abundance of  Bacteroidetes']","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0032085', 'cui_str': 'Plant oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1004289', 'cui_str': 'Phascolarctobacterium'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}]",75.0,0.555865,"The n-3 PUFA supplementation was also associated with significantly increased relative abundance of  Bacteroidetes  in phylum level ( P  < 0.01; false discovery rate (FDR) corrected  p  = 0.11), and decreased the ratio between  Firmicutes  and  Bacteroidetes  ( P  < 0.05; FDR corrected  p  = 0.16).","[{'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yalun', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Fang', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Linyan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Mei', 'Affiliation': 'Zhuhai Center for Disease Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liegang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Frontiers in nutrition,['10.3389/fnut.2022.830960']
2718,35222783,Sexual Risk Behavior among Adolescents Seeking Treatment for Posttraumatic Stress Disorder: Exploring Psychosocial & Symptom Correlates.,"Adolescents exposed to trauma experience disproportionate rates of HIV/STI. However, integrated treatment for trauma and sexual risk behavior is rare. To inform integrated prevention efforts, the current study describes prevalence and correlates of sexual risk behavior among adolescents seeking treatment for symptoms of posttraumatic stress and substance use disorders. Adolescents aged 13-18 years (N = 135; 88% female) with histories of interpersonal violence exposure completed pre-treatment questionnaires in a randomized controlled trial of an integrated psychotherapy for trauma and substance use symptomology. Adolescents reported high rates of sexual risk behaviors relative to national estimates and general mental health treatment samples. Symptoms of reexperiencing, substance use, and peer deviance were related to sexual risk behavior beyond the influence of other trauma symptoms. Individual and contextual psychosocial factors may be stronger predictors of sexual risk behavior than posttraumatic stress disorder symptoms among adolescents with trauma symptomology. Integrated interventions targeting traumatic stress, substance use, and sexual risk behavior concurrently may prevent revictimization and HIV/STI incidence among trauma-exposed youth.",2022,Individual and contextual psychosocial factors may be stronger predictors of sexual risk behavior than posttraumatic stress disorder symptoms among adolescents with trauma symptomology.,"['adolescents with trauma symptomology', 'Posttraumatic Stress Disorder', 'Adolescents aged 13-18\xa0years (N\u2009=\u2009135; 88% female) with histories of interpersonal violence exposure completed pre-treatment questionnaires', 'trauma-exposed youth', 'Adolescents', 'adolescents seeking treatment for symptoms of posttraumatic stress and substance use disorders']",['integrated psychotherapy'],"['Symptoms of reexperiencing, substance use, and peer deviance', 'sexual risk behaviors', 'Sexual Risk Behavior']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0814549', 'cui_str': 'Violence Exposure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0508935,Individual and contextual psychosocial factors may be stronger predictors of sexual risk behavior than posttraumatic stress disorder symptoms among adolescents with trauma symptomology.,"[{'ForeName': 'Devin E', 'Initials': 'DE', 'LastName': 'Banks', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Columbia, US.'}, {'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Columbia, US.'}, {'ForeName': 'Nada M', 'Initials': 'NM', 'LastName': 'Goodrum', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Columbia, US.'}, {'ForeName': 'Donte L', 'Initials': 'DL', 'LastName': 'Bernard', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Columbia, US.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Adams', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN US.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McCart', 'Affiliation': 'Oregon Social Learning Center, Eugene, OR US.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'Oregon Social Learning Center, Eugene, OR US.'}, {'ForeName': 'Ashli J', 'Initials': 'AJ', 'LastName': 'Sheidow', 'Affiliation': 'Oregon Social Learning Center, Eugene, OR US.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'de Arellano', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Columbia, US.'}, {'ForeName': 'Carla Kmett', 'Initials': 'CK', 'LastName': 'Danielson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Columbia, US.'}]",Journal of child & adolescent trauma,['10.1007/s40653-021-00378-6']
2719,35223195,"Effects of Group-delivered Stress-reduction Guided Imagery on Salivary Cortisol, Salivary Amylase, and Stress Mood in Urban, Predominantly Latino Adolescents.","Objectives


To determine acute effects of stress-reduction guided imagery delivered in group format on stress biomarkers salivary cortisol and salivary amylase, and on self-reported stress mood, in healthy, predominantly Latino adolescents.
Study Design


111 adolescent participants (94% Latino), a subset from a large, randomized controlled lifestyle intervention to improve obesity-related health behaviors, received either 4 weekly lifestyle education sessions (Lifestyle group; LS) or the same weekly lifestyle education sessions plus an additional weekly stress-reduction guided imagery session delivered in group format (Guided imagery group; GI). Salivary cortisol, salivary amylase, and self-reported stress moods were assessed before and after sessions on intervention weeks 3 and 4. Statistics: Linear mixed effects models examined within- and between-session and group differences in pre- to post-session changes.
Results


Both groups showed decreases in salivary cortisol, 5% decrease in LS group and 32% in GI group (within-group differences all  P  < .05), with between-group difference in salivary cortisol of moderate size ( P  = .05; Cohen's d = .44). Within the GI group alone, salivary cortisol decrease was similar following either the lifestyle or GI sessions ( P  = .64). There were no statistically significant amylase changes within or between groups. All 5 individual stress moods declined by 27% to 46% in the GI group (all  P  < .05), while only 1 of the 5 declined in LS group.
Conclusions


Group stress-reduction guided imagery reduces the stress biomarker salivary cortisol, as well as reducing subjective stress mood states, making it a viable modality for large scale stress-reduction interventions.",2022,"All 5 individual stress moods declined by 27% to 46% in the GI group (all  P  < .05), while only 1 of the 5 declined in LS group.
","['healthy, predominantly Latino adolescents', 'adolescent participants (94% Latino', 'in Urban, Predominantly Latino Adolescents']","['Group-delivered Stress-reduction Guided Imagery', '4 weekly lifestyle education sessions (Lifestyle group; LS) or the same weekly lifestyle education sessions plus an additional weekly stress-reduction guided imagery session delivered in group format (Guided imagery group; GI', 'stress-reduction guided imagery']","['salivary cortisol', 'Salivary cortisol, salivary amylase, and self-reported stress moods', 'salivary cortisol of moderate size', 'Salivary Cortisol, Salivary Amylase, and Stress Mood', 'individual stress moods', 'salivary cortisol decrease']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443452', 'cui_str': 'Salivary amylase'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324290', 'cui_str': 'Salivary cortisol decreased'}]",111.0,0.0322368,"All 5 individual stress moods declined by 27% to 46% in the GI group (all  P  < .05), while only 1 of the 5 declined in LS group.
","[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Weigensberg', 'Affiliation': 'Department of Pediatrics, (USC) Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Cheng K Fred', 'Initials': 'CKF', 'LastName': 'Wen', 'Affiliation': 'USC Center for Self-Report Science, Los Angeles, CA, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spruijt-Metz', 'Affiliation': 'Department of Psychology, USC Dornsife Center for Economic and Social Research, Los Angeles, CA, USA.'}, {'ForeName': 'Christianne Joy', 'Initials': 'CJ', 'LastName': 'Lane', 'Affiliation': 'Division of Biostatistics, Department of Preventive Medicine, USC Keck School of Medicine, Los Angeles, CA, USA.'}]",Global advances in health and medicine,['10.1177/21649561211067443']
2720,35223652,Effect of Paracetamol versus Ibuprofen in Adenotonsillectomy.,"Introduction


The present study aimed to compare the effects of paracetamol and ibuprofen on pain, bleeding, nausea, and vomiting following adenotonsillectomy in children.
Materials and Methods


This was a prospective, double-blinded, randomized clinical trial. Block randomization was used to assign 50 patients to two groups of paracetamol and ibuprofen. In the paracetamol group, subjects received 15 mg/kg oral paracetamol 30 minutes before the induction of anesthesia, followed by the same dosage every 6 hours postoperatively. Meanwhile, the ibuprofen-treated group took 10 mg/kg oral ibuprofen 30 minutes before and every 6 hours after the operation. The subjects in both groups received the medication for three postoperative days. The postoperative pain score was assessed 6 hours after the surgery and during the second and the third postoperative days. Nausea and vomiting episodes were recorded in the first postoperative day and first postoperative week.
Results


Based on the results, intraoperative and postoperative bleeding in both groups was not significantly different. The mean score of pain in the first postoperative day (6 hours after the surgery) and the second and the third postoperative days did not show any statistical difference. The ibuprofen group experienced fewer vomiting episodes, compared to the paracetamol group during the first postoperative day (P=0.011). Vomiting episodes in the first postoperative week did not illustrate any significant difference.
Conclusion


As evidenced by the results of the current study, Ibuprofen had the same effect on the alleviation of postoperative pain, caused fewer vomiting episodes, and did not cause excessive bleeding as an NSAID. Therefore, oral administration of ibuprofen is suggested for pain relief and management of other complications following adenotonsillectomy in children.",2021,"The ibuprofen group experienced fewer vomiting episodes, compared to the paracetamol group during the first postoperative day (P=0.011).","['children', 'Adenotonsillectomy']","['Paracetamol versus Ibuprofen', 'oral paracetamol', 'paracetamol', 'paracetamol and ibuprofen', 'ibuprofen-treated group took 10 mg/kg oral ibuprofen', 'Ibuprofen', 'ibuprofen']","['Vomiting episodes', 'vomiting episodes', 'Nausea and vomiting episodes', 'alleviation of postoperative pain', 'postoperative pain score', 'mean score of pain', 'intraoperative and postoperative bleeding', 'pain, bleeding, nausea, and vomiting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.164157,"The ibuprofen group experienced fewer vomiting episodes, compared to the paracetamol group during the first postoperative day (P=0.011).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mirashrafi', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Tavakolnejad', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behrooz', 'Initials': 'B', 'LastName': 'Amirzargar', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arezou', 'Initials': 'A', 'LastName': 'Abasi', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Amali', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of otorhinolaryngology,['10.22038/IJORL.2021.56501.2945']
2721,35223634,"Influence of Psychological Supervision on Athletes' Compliance, Mental Elasticity Characteristics and Acute Stress Disorder in Traumatic Fracture Rehabilitation Training.","Background


We aimed to explore the effect of psychological supervision on rehabilitation training compliance, mental elasticity characteristics, and acute stress disorder.
Methods


From March 2018 to March 2020, 128 athletes with traumatic fractures in Zhoukou Sports Club in China were divided into two groups using the random number table method, The intervention group (64 athletes) received psychological supervision during the rehabilitation training, while the control group (64 athletes) without psychological supervision. The rehabilitation training compliance in the two groups was observed, and the mental elasticity characteristics and acute stress disorder changes were compared between the two groups before and post-intervention.
Results


The compliance rate during postoperative rehabilitation training in the intervention group is 92.19%, which was significantly higher than 73.44% in the control group ( P <0.05). Compared with the scores before intervention, the CD-RISC score and SASRD score of the two groups were significantly lower than the scores post-intervention. The SMFA function and vexation indexes of the intervention group in three months after operation were significantly lower than those of the control group ( P <0.05). The QOL scores of the intervention group in social, environmental, psychological, and physiological fields were significantly higher than those of the control group in three months after operation ( P <0.05).
Conclusion


The implementation of psychological supervision for athletes with traumatic fractures could improve rehabilitation training compliance, increase the level of mental elasticity, and relieve acute stress disorder.",2022,"The compliance rate during postoperative rehabilitation training in the intervention group is 92.19%, which was significantly higher than 73.44% in the control group ( P <0.05).","['128 athletes with traumatic fractures in Zhoukou Sports Club in China', 'athletes with traumatic fractures', 'Methods\n\n\nFrom March 2018 to March 2020', ""Athletes' Compliance, Mental Elasticity Characteristics and Acute Stress Disorder in Traumatic Fracture Rehabilitation Training""]","['Psychological Supervision', 'psychological supervision', 'psychological supervision during the rehabilitation training, while the control group (64 athletes) without psychological supervision']","['QOL scores', 'compliance rate', 'rehabilitation training compliance', 'level of mental elasticity', 'social, environmental, psychological, and physiological fields', 'CD-RISC score and SASRD score', 'SMFA function and vexation indexes', 'mental elasticity characteristics and acute stress disorder changes']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0877237', 'cui_str': 'Traumatic fracture'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0236816', 'cui_str': 'Acute stress disorder'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C1099355', 'cui_str': 'RISC Multicomponent Nuclease'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0236816', 'cui_str': 'Acute stress disorder'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",128.0,0.00527719,"The compliance rate during postoperative rehabilitation training in the intervention group is 92.19%, which was significantly higher than 73.44% in the control group ( P <0.05).","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'School of Physical Education, Zhoukou Normal University, Zhoukou, China.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'School of Physical Education, Zhoukou Vocational and Technical College, Zhoukou, China.'}, {'ForeName': 'Yinbin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Physical Education, Zhoukou Vocational and Technical College, Zhoukou, China.'}]",Iranian journal of public health,['10.18502/ijph.v51i1.8304']
2722,35223630,Analysis on the Effect of Metformin Hydrochloride Combined with Insulin Pump for Gestational Diabetes Mellitus.,"Background


U To analyze the effect of metformin hydrochloride combined with insulin pump for gestational diabetes mellitus (GDM).
Methods


Overall, 216 patients with GDM in Zhangqiu Maternity and Child Care Hospital, Jinan, China from Aug 2018 to Dec 2020 were enrolled and randomized into research and control groups. Patients in the control group were treated with insulin pump, while those in the research group were treated with metformin hydrochloride combined with insulin pump. The clinical efficacy, blood glucose levels, serum Betatrophin, C reactive protein (CRP), Cystatin C (Cys-C), homocysteine (Hcy), adiponectin, tumor necrosis factor (TNF-α), interleukin-6 (IL-6) content, incidence of adverse pregnancy outcomes and incidence of adverse newborns of patients in the two groups were compared.
Results


After treatment, the total clinical efficiency of the research group was 84.26%, significantly higher than that of the control group (68.52%). The levels of FPG, 2hPG, HbAlc, serum Betatrophin, CRP, CysC, Hcy, adiponectin factors, TNF-α, and IL-6 in the research group were lower than those in the control group, with statistically significant differences ( P <0.05). The overall incidence of adverse pregnancy outcomes was 10.19% in the research group, and 25.93% in the control group. The comparative differences between the two groups were statistically significant ( P <0.05). The overall incidence of adverse newborns was 9.26% in the research group, and 21.30% in the control group. The comparative differences between the two groups were statistically significant as well ( P <0.05).
Conclusion


Metformin hydrochloride combined with insulin pump for GDM can significantly reduce blood glucose level, regulate serum protein factor levels, and improve adverse outcomes for mother and child, which deserves clinical promotion.",2022,"The clinical efficacy, blood glucose levels, serum Betatrophin, C reactive protein (CRP), Cystatin C (Cys-C), homocysteine (Hcy), adiponectin, tumor necrosis factor (TNF-α), interleukin-6 (IL-6) content, incidence of adverse pregnancy outcomes and incidence of adverse newborns of patients in the two groups were compared.
","['Gestational Diabetes Mellitus', '216 patients with GDM in Zhangqiu Maternity and Child Care Hospital, Jinan, China from Aug 2018 to Dec 2020', 'gestational diabetes mellitus (GDM']","['\n\n\nU', 'Metformin hydrochloride', 'metformin hydrochloride combined with insulin pump', 'insulin pump', 'Metformin Hydrochloride Combined with Insulin Pump']","['total clinical efficiency', 'levels of FPG, 2hPG, HbAlc, serum Betatrophin, CRP, CysC, Hcy, adiponectin factors, TNF-α, and IL-6', 'adverse pregnancy outcomes', 'blood glucose level, regulate serum protein factor levels', 'overall incidence of adverse newborns', 'clinical efficacy, blood glucose levels, serum Betatrophin, C reactive protein (CRP), Cystatin C (Cys-C), homocysteine (Hcy), adiponectin, tumor necrosis factor (TNF-α), interleukin-6 (IL-6) content, incidence of adverse pregnancy outcomes and incidence of adverse newborns', 'adverse outcomes']","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0770893', 'cui_str': 'Metformin hydrochloride'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0036825', 'cui_str': 'Serum protein'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",216.0,0.0340178,"The clinical efficacy, blood glucose levels, serum Betatrophin, C reactive protein (CRP), Cystatin C (Cys-C), homocysteine (Hcy), adiponectin, tumor necrosis factor (TNF-α), interleukin-6 (IL-6) content, incidence of adverse pregnancy outcomes and incidence of adverse newborns of patients in the two groups were compared.
","[{'ForeName': 'Xinghua', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Zhangqiu Maternity and Child Care Hospital, Jinan 250200, China.'}, {'ForeName': 'Guilian', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics, the Third People's Hospital of Qingdao, Qingdao 266041, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics, the Third People's Hospital of Qingdao, Qingdao 266041, China.""}, {'ForeName': 'Fanchun', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': ""Department of Obstetrics, Zhangqiu District People's Hospital, Jinan 250200, China.""}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': ""Department of Health Examination, Zhangqiu District People's Hospital, Jinan 250200, China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Department of Obstetrics and Gynecology, Yanzhou Huakang Hospital, Jining 272000, China.'}]",Iranian journal of public health,['10.18502/ijph.v51i1.8298']
2723,35223595,Effects of Cool-Down Exercise and Cold-Water Immersion Therapy on Basic Fitness and Sport-Specific Skills among Korean College Soccer Players.,"Background


We aimed to examine the effects of cool-down exercise and cold-water immersion therapy on agility, speed, power, balance, and sport-specific skill performance in college soccer players, and to provide baseline data for the development of effective recovery programs.
Methods


In August 2020, 21 male college soccer players in Seoul, Korea, were randomly divided into the following groups: control group (CG, n=7), cool-down exercise group (CDG, n=7), and cool-down exercise plus cold-water immersion group (CDCWG, n=7). Agility, speed, power, balance, and sport-specific skill performance were assessed before and after the intervention.
Results


No significant differences in Southeast Missouri (SEMO) Agility Test, 20-m sprint test, vertical jump test, or Y-balance test (right) were observed among the groups; however, there was a significant effect of time ( P <0.05) and a significant time × group interaction ( P <0.05). Significant effects of time ( P <0.001), group ( P =0.043), and a time × group interaction ( P =0.009) were observed in the Y-balance test (left). There were no between-group differences in the 22-m dribble test, shooting test (left), or shooting test (right); however, there were significant effects of time ( P <0.05) and significant time × group interactions ( P <0.05). No significant effects of group or time × group interactions were observed for the kicking test (left or right); however, there were significant effects of time ( P <0.001).
Conclusion


Addition of cold-water immersion therapy to a recovery program including cool-down exercise can promote recovery of basic and sport-specific abilities among college soccer players.",2021,"No significant effects of group or time × group interactions were observed for the kicking test (left or right); however, there were significant effects of time ( P <0.001).
","['Korean College Soccer Players', 'college soccer players', 'In August 2020, 21 male college soccer players in Seoul, Korea']","['cool-down exercise and cold-water immersion therapy', 'control group (CG, n=7), cool-down exercise group (CDG, n=7), and cool-down exercise plus cold-water immersion', 'Cool-Down Exercise and Cold-Water Immersion Therapy']","['agility, speed, power, balance, and sport-specific skill performance', 'Agility, speed, power, balance, and sport-specific skill performance', 'Basic Fitness and Sport-Specific Skills', 'Southeast Missouri (SEMO) Agility Test, 20-m sprint test, vertical jump test, or Y-balance test (right', '22-m dribble test, shooting test (left), or shooting test (right']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C3658227', 'cui_str': 'Cooling-Down Exercise'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026222', 'cui_str': 'Missouri'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4720934', 'cui_str': 'Vertical jump test'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0013132', 'cui_str': 'Dribbling from mouth'}, {'cui': 'C1444774', 'cui_str': 'Shooting sensation quality'}]",21.0,0.0182807,"No significant effects of group or time × group interactions were observed for the kicking test (left or right); however, there were significant effects of time ( P <0.001).
","[{'ForeName': 'Yoon-Hyung', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Korea Paralympic Committee, Seoul, Korea.'}, {'ForeName': 'Jin-Ho', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Sports Medicine, Korea National Sport University, Seoul, Korea.'}, {'ForeName': 'Ki-Jae', 'Initials': 'KJ', 'LastName': 'Song', 'Affiliation': 'Department of Sports Medicine, Korea National Sport University, Seoul, Korea.'}, {'ForeName': 'Jae-Keun', 'Initials': 'JK', 'LastName': 'Oh', 'Affiliation': 'Department of Sports Medicine, Korea National Sport University, Seoul, Korea.'}]",Iranian journal of public health,['10.18502/ijph.v50i11.7575']
2724,35223594,Intervention Effect of the Video Health Education Model Based on Solution-Focused Theory on Adolescents' Mental Health during the COVID-19 Pandemic.,"Background


Given the long-term impact of public health emergencies on adolescents' mental health, extensive effort should be exerted in the psychological intervention of adolescents during the COVID-19 pandemic. This study combined solution-focused theory and video health education to explore the intervention effect of this model on adolescents' mental health.
Methods


Overall, 126 volunteers with anxiety symptoms from four communities in 2021 in Anhui Province, China were randomly divided into the intervention and control groups (63 members in each group). The control group only received health education popularized in the community. By contrast, the intervention group was given the same health education and provided with solution-focused psychological counseling and short video health education related to the pandemic.
Results


Results after the intervention were as follows: 1) The Self-rating Anxiety Scale scores of both groups were low, but the effect on the intervention group was better than the control group ( P  < 0.05). 2) Both groups' positive and negative affect scores were higher and lower than those before the intervention were, but changes in the scores of the intervention group were greater than that of the control group ( P  < 0.05).
Conclusion


The group intervention of solution-focused theory combined with video health education can improve the mental health level of adolescents, effectively alleviate their anxiety and negative emotions, and improve their positive emotions.",2021,"Both groups' positive and negative affect scores were higher and lower than those before the intervention were, but changes in the scores of the intervention group were greater than that of the control group ( P  < 0.05).
","['126 volunteers with anxiety symptoms from four communities in 2021 in Anhui Province, China', ""adolescents' mental health"", ""on Adolescents' Mental Health during the COVID-19 Pandemic""]","['health education and provided with solution-focused psychological counseling and short video health education related to the pandemic', 'public health emergencies', 'solution-focused theory combined with video health education', 'Video Health Education Model Based on Solution-Focused Theory', 'health education popularized in the community']","['Self-rating Anxiety Scale scores', 'positive and negative affect scores']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0474178', 'cui_str': 'Psychological counseling'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",126.0,0.0132913,"Both groups' positive and negative affect scores were higher and lower than those before the intervention were, but changes in the scores of the intervention group were greater than that of the control group ( P  < 0.05).
","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Design Art, School of Information Engineering, Fuyang Normal University, Fuyang 236037, China.'}, {'ForeName': 'Yongchun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Design Art, School of Information Engineering, Fuyang Normal University, Fuyang 236037, China.'}]",Iranian journal of public health,['10.18502/ijph.v50i11.7574']
2725,35223593,Efficacy of Shenqi Jiangtang Granules-Assisted Western Medicine in the Treatment of Gestational Diabetes Mellitus (GDM).,"Background


We aimed to investigate the efficacy of Shenqi Jiangtang granules-assisted Western medicine in the treatment of gestational diabetes mellitus (GDM).
Methods


A total of 147 patients with GDM treated in Qilu Hospital of Shandong University from Jan 2018 to Apr 2019 were enrolled. They were randomly divided into traditional Chinese medicine (TCM) combined with Western medicine group, Western medicine group and control group. The control group was treated with exercise combined with diet therapy, and the Western medicine group was additionally treated with metformin tablets. The TCM combined with Western medicine group was additionally treated with Shenqi Jiangtang granules.
Results


After treatment, the levels of 10 indicators in the three groups were lower than those before treatment ( P  < 0.05). These indicators were the lowest in the TCM combined with Western medicine group. However, high-density lipoprotein cholesterol (HDL-C), glutathione peroxidase (GSH-PX) and superoxide dismutase (SOD) after treatment increased in the three groups compared with those before treatment ( P  < 0.05), which was the most obvious in the TCM combined with Western medicine group. After treatment, the number of patients with natural delivery in the TCM combined with Western medicine group was the largest. The incidences of complications in pregnant women, fetuses and newborns were the lowest in the TCM combined with Western medicine group.
Conclusion


Application of Shenqi Jiangtang granules-assisted Western medicine in patients with GDM can effectively control blood glucose and lipid levels, enhance antioxidant capacity, reduce the levels of inflammatory cytokines and decrease the incidence of adverse pregnancy outcomes.",2021,"The incidences of complications in pregnant women, fetuses and newborns were the lowest in the TCM combined with Western medicine group.
","['147 patients with GDM treated in Qilu Hospital of Shandong University from Jan 2018 to Apr 2019 were enrolled', 'Gestational Diabetes Mellitus (GDM', 'patients with GDM', 'gestational diabetes mellitus (GDM']","['exercise combined with diet therapy', 'traditional Chinese medicine (TCM) combined with Western medicine group, Western medicine group and control group', 'Shenqi Jiangtang Granules-Assisted Western Medicine', 'TCM combined with Western medicine', 'Shenqi Jiangtang granules-assisted Western medicine', 'metformin tablets']","['control blood glucose and lipid levels, enhance antioxidant capacity', 'number of patients with natural delivery', 'high-density lipoprotein cholesterol (HDL-C), glutathione peroxidase (GSH-PX) and superoxide dismutase (SOD', 'incidences of complications', 'levels of 10 indicators']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal resection'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3713333', 'cui_str': 'shenqi'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",147.0,0.0197918,"The incidences of complications in pregnant women, fetuses and newborns were the lowest in the TCM combined with Western medicine group.
","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'International Medical Services, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Jinan Lixiaqu Municipal Center For Disease Control and Precention, Jinan 250100, China.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': 'Operation Room, The Affiliated Hospital of Shandong University of TCM, Jinan 250011, China.'}, {'ForeName': 'Runjie', 'Initials': 'R', 'LastName': 'Wan', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Jianjian', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan 250012, China.'}]",Iranian journal of public health,['10.18502/ijph.v50i11.7573']
2726,35223573,The Effect of Nursing Simulation on the Clinical Judgment of Nursing Care for Patients with Increased Intracranial Pressure (IICP).,"Background


Nursing educators commonly adopt simulations to educate nursing students and evaluate their clinical thinking, clinical reasoning, and clinical judgment. We aimed to determine the effectiveness of established nursing care simulations by evaluating, through video, a select number of nursing students in scenarios that simulate nursing care for Increased Intracranial Pressure (IICP) patients.
Methods


The participants were students in their senior year at a nursing college in South Korea in 2018. We adopted a mixed-method design by first conducting a nonequivalent control group pre-test/post-test research design, then analyzing the experimental group's simulation videos. The participants consisted of 38 students in the experimental group and 39 students in the control group, and each group consisted of 9 teams. This study measured the level of anxiety (Cronbach's α=0.780), critical thinking (Cronbach's α=0.895), performance (Cronbach's α=0.927), theoretical knowledge (Cronbach's α=0.970), and analyzed clinical judgments by directly reviewing video from the experimental group. We used a mixed methods appraisal tool (MMAT) version 2018 as its research checklist.
Results


Confidence ( P =0.000), theoretical knowledge ( P =0.000), clinical performance ( P =0.017) indicated statistically significant increases in the experimental group. We subsequently identified 10 clinical judgment processes, including ""Identify the patient's condition"" to ""Reassess the condition after symptoms improve"" by analyzing the simulation videos.
Conclusion


Developing a simulation for nursing care is effective in honing students' clinical judgment and enhancing their theoretical knowledge, confidence, and clinical performance.",2021,"Results


Confidence ( P =0.000), theoretical knowledge ( P =0.000), clinical performance ( P =0.017) indicated statistically significant increases in the experimental group.","['participants consisted of 38 students in the experimental group and 39 students in the control group, and each group consisted of 9 teams', 'participants were students in their senior year at a nursing college in South Korea in 2018', 'nursing students in scenarios that simulate nursing care for Increased Intracranial Pressure (IICP) patients', 'Patients with Increased Intracranial Pressure (IICP']",['Nursing Simulation'],"['clinical performance', 'theoretical knowledge']","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0505029,"Results


Confidence ( P =0.000), theoretical knowledge ( P =0.000), clinical performance ( P =0.017) indicated statistically significant increases in the experimental group.","[{'ForeName': 'Ae Ri', 'Initials': 'AR', 'LastName': 'Jang', 'Affiliation': 'Department of Nursing, Nambu University, 1 Nambudae-gil, Gwangsan-gu, Gwangju 62271, Republic of Korea.'}, {'ForeName': 'Jeong Eun', 'Initials': 'JE', 'LastName': 'Moon', 'Affiliation': 'Department of Nursing, Honam University, 100 Honamdae-gil, Gwangsan-gu, Gwangju 62399, Republic of Korea.'}]",Iranian journal of public health,['10.18502/ijph.v50i10.7506']
2727,35223572,Effects of Image-Sandplay Therapy on the Mental Health and Subjective Well-Being of Children with Autism.,"Background


Autism significantly affects mental health and lowers subjective well-being (SWB). The rehabilitation therapy of autism is attracting widespread attention. We aimed to explore the effects of image-sandplay therapy on the mental health and SWB of children with autism.
Methods


A total of 90 children with autism treated in Changchun Women and Children Health Hospital from Jan 2019 to Jun 2020 were enrolled by convenient sampling method. They were randomly divided into control (n=45) and observation (n=45) groups. The observation group had a 12-week image-sandplay therapy based on conventional rehabilitation therapy. In the image-sandplay therapy, the one-to-one intervention was provided once a week, 60 min in each. Autism treatment evaluation checklist (ATEC), autism behavior checklist (ABC), Conners parent symptom questionnaire (PSQ), satisfaction with life scale (SWLS), and positive and negative affect scale for children (PANAS-C) of the two groups were assessed.
Results


After intervention, the observation group showed lower scores in ATEC scale and ABC scale than the control group, and the difference show statistical significance ( P <0.05). Meanwhile, the observation group showed significantly lower scores in PSQ scale than the control group, showing a significant difference ( P <0.05). The observation group shows higher scores in SWLS scale and positive affect scores than the control group, as well as significantly lower negative affected scores than the control groups, showing a significant difference ( P <0.05).
Conclusion


Image-sandplay therapy can improve the symptoms of children with autism and is conducive to promoting mental health and increasing SWB. It is a feasible and effective rehabilitation method.",2021,"The observation group shows higher scores in SWLS scale and positive affect scores than the control group, as well as significantly lower negative affected scores than the control groups, showing a significant difference ( P <0.05).
","['90 children with autism treated in Changchun Women and Children Health Hospital from Jan 2019 to Jun 2020 were enrolled by convenient sampling method', 'children with autism', 'Children with Autism']","['Image-Sandplay Therapy', 'image-sandplay therapy based on conventional rehabilitation therapy', 'image-sandplay therapy']","['Autism treatment evaluation checklist (ATEC), autism behavior checklist (ABC), Conners parent symptom questionnaire (PSQ), satisfaction with life scale (SWLS), and positive and negative affect scale for children (PANAS-C', 'SWLS scale and positive affect scores', 'PSQ scale', 'mental health and lowers subjective well-being (SWB', 'lower scores in ATEC scale and ABC scale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0162508', 'cui_str': 'jun Oncogene'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0449370', 'cui_str': 'Method of sampling'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C2350829', 'cui_str': 'Sandplay'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0557980', 'cui_str': 'Evaluating interventions'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",90.0,0.00981386,"The observation group shows higher scores in SWLS scale and positive affect scores than the control group, as well as significantly lower negative affected scores than the control groups, showing a significant difference ( P <0.05).
","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'School of Psychology, Northeast Normal University, Changchun, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'School of Psychology, Northeast Normal University, Changchun, China.'}]",Iranian journal of public health,['10.18502/ijph.v50i10.7505']
2728,35223896,Mycophenolate Mofetil (CellCept®) in Combination With Low Dose Prednisolone in Moderate to Severe Graves' Orbitopathy.,"Although corticosteroids are currently the first-choice drug for thyroid eye disease (TED), in 20-30% of cases, patients show poor or non-existent responses, and when the drug is withdrawn, 10-20% of patients relapse. Thus, in this study, we aimed to investigate the efficacy of the combined use of mycophenolate mofetil (CellCept®) and low dose oral prednisolone in patients with moderate to severe Graves' orbitopathy (GO). For the first time, we investigated the relationship between TED-related parameters and proptosis reduction. In a prospective, non-randomized, interventional case series, 242 patients with moderate-to-severe GO were, assigned to receive oral prednisolone (5 mg/ d) and mycophenolate mofetil (CellCept®) (one 500 mg tablet twice per day according to the therapeutic response). The patients were monitored regularly during the 3rd, 6th, 12th, and 18th month of treatment. The main outcome measures were the clinical activity score (CAS), intraocular pressure (IOP), diplopia, proptosis and visual acuity. We also assessed the relationship between the main outcomes with proptosis changes and time to improvement (months). Adverse effects were recorded during each visit. The clinical response rate increased from 67.7% on the third month to 89.2% on the sixth month, and 94.2% on the 12th month. This therapeutic response continued until the 18th month of follow-up. The CAS responses [disease inactivation (CAS <3)] improved during our study: 70.6% on the third month, 90.0% on the sixth month, and 92.5% at 12th month. These conditions continued until the 18th month of follow-up. Proptosis improvement was 52% on the third month, 71% on the sixth month, 83% on the 12th month, and 87.1% on the 18th month. Changes in IOP and visual acuity were not significant ( P  = 0.568 and 0.668, respectively). The patient showed significant improvement in the Gorman score. A Shorter duration of treatment was seen in patients with earlier onset of intervention, younger age, and lack of all extraocular muscle (EOM) enlargement on computed tomography (CT) scan ( p  < 0.05). In addition, a better response (more reduction) in proptosis was related to: younger age at disease, earlier treatment intervention (less interval from the time the diagnosis of moderate-to-severe GO was made until medication initiation), shorter treatment time (less time to improvement), less IOP, lack of EOM enlargement on CT scan, and lack of diplopia ( P  < 0.05). Adverse events occurred in six patients. Findings show that mycophenolate mofetil (CellCept®) plus low-dose prednisolone can be introduced as a new optimal dosing regimen in GO due to its better effect on chronic complications such as proptosis and diplopia.",2022,"Changes in IOP and visual acuity were not significant ( P  = 0.568 and 0.668, respectively).","['242 patients with moderate-to-severe GO', ""patients with moderate to severe Graves' orbitopathy (GO""]","['oral prednisolone', 'Prednisolone', 'mycophenolate mofetil (CellCept®', 'mycophenolate mofetil (CellCept®) plus low-dose prednisolone', 'prednisolone', 'Mycophenolate Mofetil (CellCept®']","['clinical response rate', 'Gorman score', 'Proptosis improvement', 'CAS responses [disease inactivation', 'IOP, lack of EOM enlargement on CT scan, and lack of diplopia', 'Adverse events', 'Changes in IOP and visual acuity', 'clinical activity score (CAS), intraocular pressure (IOP), diplopia, proptosis and visual acuity', 'Adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0592558', 'cui_str': 'Cellcept'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015300', 'cui_str': 'Exophthalmos'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0012569', 'cui_str': 'Diplopia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",242.0,0.0390812,"Changes in IOP and visual acuity were not significant ( P  = 0.568 and 0.668, respectively).","[{'ForeName': 'Mohammad Taher', 'Initials': 'MT', 'LastName': 'Rajabi', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Mohsen', 'Initials': 'SM', 'LastName': 'Rafizadeh', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Mohammadi', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Eshraghi', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Mohammadi', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyedeh Simindokht', 'Initials': 'SS', 'LastName': 'Hosseini', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Bagher', 'Initials': 'MB', 'LastName': 'Rajabi', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Mohsen', 'Initials': 'MM', 'LastName': 'Keshmirshekan', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Shahriari', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyedeh Zahra', 'Initials': 'SZ', 'LastName': 'Poursayed Lazarjani', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Mehdi', 'Initials': 'MM', 'LastName': 'Parandin', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Frontiers in medicine,['10.3389/fmed.2022.788228']
2729,35223882,Efficacy of Initial vs. Delayed Photodynamic Therapy in Combination With Conbercept for Polypoidal Choroidal Vasculopathy.,"Purpose


To compare the efficacy of initial vs. delayed photodynamic therapy (PDT) in combination with intravitreal injection of conbercept (IVC) for polypoidal choroidal vasculopathy (PCV).
Design


Multicenter, randomized, non-inferiority clinical trial.
Subjects


Naïve PCV patients.
Methods


Patients were randomized 1:1 into two groups: initial PDT with IVC and delayed PDT with IVC. At baseline, patients in the initial combination group were treated with PDT and IVC within 1 week, while patients in the delayed combination group were treated with IVC alone. PDT and IVC was given PRN during the follow-up in each group.
Main Outcome Measures


Non-inferiority of delayed PDT with IVC to initial PDT with IVC for mean change in best-corrected visual acuity from baseline to month 12 (95% CI of the difference entirely above -5 letters).
Results


Eighty-six patients were enrolled, with 43 in each group. At month 12, the change of BCVA in initial combination group was equivalent to that in the delayed combination group, with gains of 6.42 ± 1.89 and 7.49 ± 2.14 (mean ± standard error) letters, respectively [delayed group minus initial group: 1.07 letters; 95% confidence interval (CI): -4.62 to 6.76;  P   non - inferiority  = 0.0198]. The rates of complete polyp regression were 66.67 and 45.83% in the initial and delayed combination groups, respectively. The difference was not statistically significant ( P  = 0.386). The mean reductions of CRT were 204.77 ± 28.79 and 84.14 ± 30.62 μm in each group respectively. The difference was statistically significant ( P  = 0.005). In addition, the mean injection numbers were 3.47 ± 2.39 and 4.91 ± 2.65 in each group respectively. The differences were statistically significant ( P  = 0.010).
Conclusions


There was effective in both groups in patients with PCV. The initial combination group showed a more efficient decrease in CRT and polyp regression, along with fewer injections. However, the initial combination group was non-inferior compared with the delayed combination group in terms of the improvement of BCVA.
Trial Registration


https://ClinicalTrials.gov, Identifier: NCT02821520.",2021,"However, the initial combination group was non-inferior compared with the delayed combination group in terms of the improvement of BCVA.
","['Polypoidal Choroidal Vasculopathy', 'polypoidal choroidal vasculopathy (PCV', 'Subjects\n\n\nNaïve PCV patients', 'Eighty-six patients were enrolled, with 43 in each group']","['intravitreal injection of conbercept (IVC', 'initial vs. delayed photodynamic therapy (PDT', 'initial PDT with IVC and delayed PDT with IVC', 'PDT and IVC', 'IVC alone', 'Initial vs. Delayed Photodynamic Therapy']","['mean injection numbers', 'change of BCVA', 'mean reductions of CRT', 'rates of complete polyp regression', 'CRT and polyp regression', 'inferiority of delayed PDT with IVC to initial PDT with IVC for mean change in best-corrected visual acuity']","[{'cui': 'C1504336', 'cui_str': 'Polypoidal choroidal vasculopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]",86.0,0.0984543,"However, the initial combination group was non-inferior compared with the delayed combination group in terms of the improvement of BCVA.
","[{'ForeName': 'Zuhua', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yating', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Suqin', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Pei', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Yingzi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Sir Run Run Shaw Hospital, Medical College of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Junyan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Bothwin Clinical Study Consultant, Shanghai, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, China.'}]",Frontiers in medicine,['10.3389/fmed.2021.791935']
2730,35223871,"Impact of Parallel Topical Treatment with Nadifloxacin and Adapalene on Acne Vulgaris Severity and Quality of Life: A Prospective, Uncontrolled, Multicentric, Noninterventional Study.","Introduction


Daily parallel application of adapalene and nadifloxacin has been determined to be effective and well tolerated in patients with acne vulgaris in randomized, controlled clinical studies. Here, the authors report the results from a large, prospective, uncontrolled, multicentric, noninterventional study under real-life conditions in Germany. The effect of treatment on acne severity, safety, and, for the first time, health-related quality of life (HRQoL) was investigated.
Methods


Of the 292 patients (safety collective: 231 adults, 61 adolescents) who had at least grade 4 acne vulgaris on the face as per the Leeds Revised Acne Grading (LRAG), 273 (efficacy collective: 213 adults, 60 adolescents) were treated with adapalene 0.1% cream or gel and nadifloxacin 1% cream for the defined minimum of 28 days. Patients were evaluated for acne severity, acne-related facial symptoms, HRQoL, overall assessment of therapy, and safety.
Results


After the median treatment duration of 37 and 38 days (adults and adolescents, respectively), 93.4% and 85.0% of adults and adolescents, respectively, exhibited a sustained decrease in acne severity. The LRAG decreased by at least 3 scores in 29.1% and 24.6% of female and male adults, respectively. HRQoL improved in 67.9% and 63.5% of adults and adolescents, respectively (median improvement in the Dermatology Life Quality Index scores per patient of 3.0 [female adults], 1.0 [male adults], and 2.0 for all adolescents in the Children's Dermatology Life Quality Index). Female adults were more impaired in terms of HRQoL compared to male adults. The 2 best overall efficacy ratings were provided by physicians in 79.3% and 69.5% and by patients in 68.5% and 58.3% of adult and adolescent cases, respectively. The treatment was well tolerated, as reflected in the low number of 9 mild adverse events (AEs), all of which resolved without treatment. However, 4 patients terminated the study prematurely due to AEs.
Conclusion


In this study, the parallel use of adapalene and nadifloxacin for at least 5 weeks resulted in a rapid improvement in acne severity, an increase in HRQoL, and a good safety profile. Therefore, it represents a promising treatment option that offers the possibility of flexible therapy adjustment.",2021,"HRQoL improved in 67.9% and 63.5% of adults and adolescents, respectively (median improvement in the Dermatology Life Quality Index scores per patient of 3.0 [female adults], 1.0 [male adults], and 2.0 for all adolescents in the Children's Dermatology Life Quality Index).","['Female adults', '231 adults, 61 adolescents) who had at least grade 4 acne vulgaris on the face as per the Leeds Revised Acne Grading (LRAG), 273 (efficacy collective: 213 adults, 60 adolescents', '292 patients (safety collective', 'patients with acne vulgaris']","['Nadifloxacin and Adapalene', 'adapalene 0.1% cream or gel and nadifloxacin 1% cream', 'adapalene and nadifloxacin']","['Dermatology Life Quality Index scores', 'tolerated', 'HRQoL', 'acne severity, acne-related facial symptoms, HRQoL, overall assessment of therapy, and safety', 'acne severity, safety, and, for the first time, health-related quality of life (HRQoL', 'acne severity', 'overall efficacy ratings', 'Acne Vulgaris Severity and Quality of Life', 'LRAG']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0286402', 'cui_str': 'nadifloxacin'}, {'cui': 'C0165631', 'cui_str': 'adapalene'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",292.0,0.0219204,"HRQoL improved in 67.9% and 63.5% of adults and adolescents, respectively (median improvement in the Dermatology Life Quality Index scores per patient of 3.0 [female adults], 1.0 [male adults], and 2.0 for all adolescents in the Children's Dermatology Life Quality Index).","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Neumeister', 'Affiliation': 'Department of Medical Science/Research & Development, Clinical Research, Dr. Pfleger Arzneimittel GmbH, Bamberg, Germany.'}, {'ForeName': 'Rolf-Hasso', 'Initials': 'RH', 'LastName': 'Bödeker', 'Affiliation': 'TransMit Project Area for Medical Statistics, Justus Liebig University, Giessen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schwantes', 'Affiliation': 'Department of Medical Science/Research & Development, Clinical Research, Dr. Pfleger Arzneimittel GmbH, Bamberg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Borelli', 'Affiliation': 'Unit of Aesthetic Dermatology and Laser, Department of Dermatology, Eberhard Karls University, Tübingen, Germany.'}]",Biomedicine hub,['10.1159/000520447']
2731,35224249,Frequency of Change in Assessment from Bony Union to Nonunion after Lumbar Interbody Fusion: A Multicenter Study.,"Introduction


Assessments of early postoperative bony union after posterior lumbar interbody fusion via computed tomography (CT) have revealed cases in which interbody fixation by bony union resulted in nonfusion due to bone absorption. The apparent bone union state reverted to a nonunion state several months later, exhibiting a so-called ""fake union"" phenomenon. Additionally, few reports have evaluated the effect of teriparatide on bony union. The present study aimed to evaluate the frequency of change in assessment from fusion to nonfusion in the postoperative follow-up of lumbar interbody fusion, compare the late postoperative bony union rates in groups with or without early postoperative fusion, and examine the effect of postoperative teriparatide in those groups.
Methods


Sixty-nine subjects enrolled from multiple hospitals were prospectively evaluated following single-level lumbar interbody fusion. The patients were randomly allocated into treatment with or without weekly postoperative teriparatide. The subjects were then classified as having bony union or nonfusion at 2 months postoperatively, and fusion rates at 6 months were compared. For the evaluation of bony union, blinded radiological examinations were performed via CT. Additional comparisons were made according to teriparatide use.
Results


The rate of nonunion at 6 months postoperatively in patients with fusion at 2 months postoperatively was 27.8%. Among subjects with bony union at 2 months postoperatively, the fusion rate at 6 months in those who received teriparatide was 93.3% (p=0.027) versus 57.1% in those who did not.
Conclusions


The rate of nonunion at 6 months postoperatively in patients exhibiting union at 2 months after surgery was 27.8%. Postoperative weekly teriparatide treatment significantly reduced the rate of fake union.",2022,The rate of nonunion at 6 months postoperatively in patients exhibiting union at 2 months after surgery was 27.8%.,['Methods\n\n\nSixty-nine subjects enrolled from multiple hospitals'],"['teriparatide', 'posterior lumbar interbody fusion via computed tomography (CT', 'postoperative teriparatide']","['rate of fake union', 'late postoperative bony union rates', 'bone union state', 'rate of nonunion', 'fusion rate']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0391889', 'cui_str': 'Synostosis'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]",69.0,0.0270527,The rate of nonunion at 6 months postoperatively in patients exhibiting union at 2 months after surgery was 27.8%.,"[{'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Oba', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University, School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University, School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Shibata', 'Affiliation': 'Departments of Community Health and Preventive Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Ohba', 'Affiliation': 'Department of Orthopaedic Surgery, University of Yamanashi, School of Medicine, Chuo, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Isogai', 'Affiliation': 'Medical Affairs Department, Pharmaceutical Business Administration Division, Asahi Kasei Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Shugo', 'Initials': 'S', 'LastName': 'Kuraishi', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University, School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Ikegami', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University, School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Uehara', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University, School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Takizawa', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University, School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Munakata', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University, School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Terue', 'Initials': 'T', 'LastName': 'Hatakenaka', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University, School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Ojima', 'Affiliation': 'Departments of Community Health and Preventive Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Zentaro', 'Initials': 'Z', 'LastName': 'Yamagata', 'Affiliation': 'Departments of Health Science for Clinical Medicine, Graduate School of Medicine, University of Yamanashi, Chuo, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Haro', 'Affiliation': 'Department of Orthopaedic Surgery, University of Yamanashi, School of Medicine, Chuo, Japan.'}]",Spine surgery and related research,['10.22603/ssrr.2020-0032']
2732,35224090,Prolonged Application of Continuous Passive Movement Improves the Postoperative Recovery of Tibial Head Fractures: A Prospective Randomized Controlled Study.,"Methods


60 patients with THFs were randomly and equally divided into the CPM group and non-CPM group. Both groups immediately received CPM and conventional physical therapies during hospitalization. After discharge, the non-CPM group was treated with conventional physical therapy alone, while the CPM group received conventional physical training in combination with CPM treatment. At 6 weeks and 6 months postoperatively, the primary outcome which was knee ROM and the secondary outcome which was knee functionality and quality of life were evaluated.
Results


The CPM group had a significantly increased ROM at both follow-up time points. The Knee Society Score, UCLA activity score, and the EuroQoL as well as the pain analysis showed significantly better results of the CPM group than the non-CPM group.
Conclusions


The prolonged application of CPM therapy is an effective method to improve the postoperative rehabilitation of THFs.",2022,"The Knee Society Score, UCLA activity score, and the EuroQoL as well as the pain analysis showed significantly better results of the CPM group than the non-CPM group.
","['Tibial Head Fractures', '60 patients with THFs']","['CPM and conventional physical therapies', 'CPM group and non-CPM', 'conventional physical therapy alone', 'Continuous Passive Movement', 'conventional physical training in combination with CPM treatment']","['ROM', 'knee ROM', 'knee functionality and quality of life', 'Knee Society Score, UCLA activity score, and the EuroQoL as well as the pain analysis']","[{'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",60.0,0.016518,"The Knee Society Score, UCLA activity score, and the EuroQoL as well as the pain analysis showed significantly better results of the CPM group than the non-CPM group.
","[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Kabst', 'Affiliation': 'University Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus at Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Xinggui', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'University Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus at Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kleber', 'Affiliation': 'Department of Orthopedics, Trauma Surgery and Plastic Surgery, University Hospital of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Amlang', 'Affiliation': 'University Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus at Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Findeisen', 'Affiliation': 'University Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus at Technische Universität Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Kennedy Institute of Rheumatology, Nuffield Department of Orthopedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Zwingenberger', 'Affiliation': 'University Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus at Technische Universität Dresden, 01307 Dresden, Germany.'}]",BioMed research international,['10.1155/2022/1236781']
2733,35224058,Short-Term Supplementation With Fermented Red Clover Extract Reduces Vascular Inflammation in Early Post-menopausal Women.,"The decline in estrogen at menopause poses a critical challenge to cardiovascular and metabolic health. Recently, a growing interest in the role of phytoestrogens, with a particular focus on isoflavones, has emerged as they can bind to estrogen receptors and may mimic the roles of endogenous estrogen. Fermented red clover extract (RC) contains isoflavones with superior bioavailability compared to non-fermented isoflavones, however little is known regarding the impact of isoflavones on cardiovascular and metabolic health. We assessed markers of vascular health in plasma and skeletal muscle samples obtained from healthy but sedentary early post-menopausal women ( n  = 10; 54 ± 4 years) following 2 weeks of twice daily treatment with placebo (PLA) or RC (60 mg isoflavones per day). The two interventions were administered using a randomized, double-blind, crossover design with a two-week washout period. Plasma samples were utilized for assessment of markers of vascular inflammation. There was a statistically significant reduction (~5.4%) in vascular cell adhesion molecule 1 (VCAM-1) following 2 weeks of RC supplementation compared to PLA ( p  = 0.03). In contrast, there was no effect of RC supplementation compared to PLA on skeletal muscle estrogen receptor content and enzymes related to vascular function, and angiogenesis. Supplementation with RC reduces vascular inflammation in early post-menopausal women and future studies should address the long-term impact of daily supplementation with RC after menopause.",2022,There was a statistically significant reduction (~5.4%) in vascular cell adhesion molecule 1 (VCAM-1) following 2 weeks of RC supplementation compared to PLA ( p  = 0.03).,"['early post-menopausal women', 'Early Post-menopausal Women', 'healthy but sedentary early post-menopausal women ( n  = 10; 54 ± 4 years']","['Fermented red clover extract (RC) contains isoflavones', 'RC', 'Short-Term Supplementation With Fermented Red Clover Extract', 'isoflavones', 'PLA', 'placebo (PLA) or RC', 'RC supplementation']","['skeletal muscle estrogen receptor content and enzymes related to vascular function, and angiogenesis', 'vascular cell adhesion molecule 1 (VCAM-1', 'Vascular Inflammation', 'vascular inflammation']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0939844', 'cui_str': 'Red Clover Preparation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.166387,There was a statistically significant reduction (~5.4%) in vascular cell adhesion molecule 1 (VCAM-1) following 2 weeks of RC supplementation compared to PLA ( p  = 0.03).,"[{'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Wickham', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Line B', 'Initials': 'LB', 'LastName': 'Nørregaard', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Oxfeldt', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Cheung', 'Affiliation': 'Environmental Ergonomics Lab, Faculty of Applied Health Sciences, Brock University, St. Catharines, ON, Canada.'}, {'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Gliemann', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Hellsten', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}]",Frontiers in cardiovascular medicine,['10.3389/fcvm.2022.826959']
2734,35224034,Effects of Home-Based Baduanjin Exercise on Left Ventricular Remodeling in Patients With Acute Anterior ST-Segment Elevation Myocardial Infarction: Study Protocol for a Randomized Controlled Trial.,"Background


Left ventricular (LV) remodeling after ST-segment elevation myocardial infarction (STEMI) is a major pathological basis associated with heart failure and increased mortality. Exercise-based cardiac rehabilitation has been verified to significantly improve prognosis and quality of life. As a traditional Chinese Qigong, Baduanjin exercise has effectively alleviated adverse LV remodeling in STEMI patients. Despite this, participation in exercise rehabilitation remains low, and home-based exercise rehabilitation may be an alternative approach. Besides, anterior STEMI is reported to have higher risk of adverse LV remodeling. However, the efficiency regarding home-based Baduanjin exercise on LV remodeling in anterior STEMI patients remains uncertain currently.
Methods/Design


A single-blind, randomized controlled clinical trial was conducted to explore the efficacy and safety of home-based Baduanjin exercise in anterior STEMI patients compared with moderate intensity aerobic walking. A total of 114 participants were assigned randomly to the Baduanjin group or walking control group at a 1:1 ratio. Eligible participants practiced Baduanjin or walking exercise (5 times a week) for 12 weeks, and then followed up for another 12 weeks. The primary outcome is a relative change in the LV end-diastolic volume. The secondary outcomes include the plasma levels of hypersensitive C-reactive protein and interleukin 6, health-related quality of life measured by EQ-5D-5L, LV ejection fraction, patient health questionnaire-9, generalized anxiety disorder screener-7, short physical performance battery score, and clinical endpoint events. The proportion of circulating regulatory T-cells were also assessed. Adverse events were recorded throughout the trial for safety evaluation. Data were be analyzed by researchers blinded to the treatment allocation.
Discussion


This study provided powerful evidence for the use of home-based Baduanjin exercise in anterior STEMI patients in alleviating LV remodeling and improving clinical outcomes.
Trial Registration


The Research Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine has approved this study (ZYYECK[2020]045). Written informed consent of patients were required. This trial is registered in the Chinese Clinical Trial Registry (ChiCTR2100047298).
Dissemination


Our results will be published in peer-reviewed journals and disseminated through academic conferences and the Internet.",2022,"The secondary outcomes include the plasma levels of hypersensitive C-reactive protein and interleukin 6, health-related quality of life measured by EQ-5D-5L, LV ejection fraction, patient health questionnaire-9, generalized anxiety disorder screener-7, short physical performance battery score, and clinical endpoint events.","['STEMI patients', 'Patients With Acute Anterior ST-Segment Elevation Myocardial Infarction', 'A total of 114 participants', 'anterior STEMI patients compared with moderate intensity aerobic walking']","['Baduanjin or walking exercise', 'home-based Baduanjin exercise', 'Home-Based Baduanjin Exercise', 'Baduanjin group or walking control', 'Exercise-based cardiac rehabilitation', 'Baduanjin exercise']","['plasma levels of hypersensitive C-reactive protein and interleukin 6, health-related quality of life measured by EQ-5D-5L, LV ejection fraction, patient health questionnaire-9, generalized anxiety disorder screener-7, short physical performance battery score, and clinical endpoint events', 'adverse LV remodeling', 'proportion of circulating regulatory T-cells', 'Adverse events', 'efficacy and safety', 'Left Ventricular Remodeling', 'relative change in the LV end-diastolic volume', 'prognosis and quality of life']","[{'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839746', 'cui_str': 'Acute anterior ST segment elevation myocardial infarction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455833', 'cui_str': 'Left ventricular end-diastolic cavity size'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",114.0,0.0855962,"The secondary outcomes include the plasma levels of hypersensitive C-reactive protein and interleukin 6, health-related quality of life measured by EQ-5D-5L, LV ejection fraction, patient health questionnaire-9, generalized anxiety disorder screener-7, short physical performance battery score, and clinical endpoint events.","[{'ForeName': 'Yinhe', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'The First Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': 'The First Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'The First Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'The First Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Junmao', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'The First Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Gong', 'Affiliation': 'Department of Cardiovascular Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Qingmin', 'Initials': 'Q', 'LastName': 'Chu', 'Affiliation': 'Department of Cardiovascular Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yijun', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'Department of Cardiovascular Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Chuanjin', 'Initials': 'C', 'LastName': 'Luo', 'Affiliation': 'Department of Cardiovascular Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Keyu', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Interventional Room, The First Hospital Affiliated of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xinjun', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiovascular Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}]",Frontiers in cardiovascular medicine,['10.3389/fcvm.2022.778583']
2735,35224436,"A Phase I Trial to Determine the Pharmacokinetics, Psychotropic Effects, and Safety Profile of a Novel Nanoparticle-Based Cannabinoid Spray for Oromucosal Delivery.","Introduction


A phase I, open-label clinical trial in healthy male subjects was conducted to assess the pharmacokinetic and safety profile of an oromucosal cannabinoid spray (AP701) containing a lipid-based nanoparticular drug formulation standardized to ∆-9-tetrahydrocannabinol (THC).
Methods


Twelve healthy male subjects received a single dose of AP701 (12 sprays) containing 3.96 mg THC. Plasma samples were drawn 10 min-30 h post dose for analysis of THC and the active metabolite 11-hydroxy-∆-9-THC (11-OH-THC).
Results


The single dose of the applied oromucosal cannabinoid spray AP701 (12 sprays, 3.96 mg THC) resulted in a mean maximum plasma concentration ( C max ) of 2.23 ng/mL (90% CI 1.22-3.24) and a mean overall exposure (area under the concentration-time curve from time 0 to last measurable concentration [AUC 0-t ]) of 7.74 h × ng/mL (90% CI 5.03-10.45) for THC. For the active metabolite 11-OH-THC, a  C max  of 2.09 mg/mL (90% CI 1.50-2.68) and AUC 0-t  of 10.4 h × ng/mL (90% CI 7.03-13.77) was found. The oromucosal cannabinoid spray AP701 caused only minor psychotropic effects despite the relatively high dosage applied by healthy subjects. No serious adverse effects occurred. Overall, the oromucosal cannabinoid spray AP701 was well tolerated.
Conclusion


Compared to currently available drugs on the market, higher AUC values could be detected for the oromucosal cannabinoid spray AP701 despite administration of a lower dose. These comparatively higher blood levels caused only minor psychotropic adverse effects. The oromucosal cannabinoid spray AP701 was well tolerated at a single dose of 3.96 mg THC. The oromucosal administration may provide an easily applicable and titratable drug formulation with a high safety and tolerability profile.",2022,No serious adverse effects occurred.,"['Twelve healthy male subjects', 'healthy male subjects']","['oromucosal cannabinoid spray (AP701) containing a lipid-based nanoparticular drug formulation standardized to ∆-9-tetrahydrocannabinol', 'Novel Nanoparticle-Based Cannabinoid Spray', 'AP701 (12 sprays) containing 3.96 mg THC']","['tolerated', 'mean maximum plasma concentration ( C max ']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1299004', 'cui_str': 'Oromucosal route'}, {'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0023767', 'cui_str': 'Lipid A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",12.0,0.114805,No serious adverse effects occurred.,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lorenzl', 'Affiliation': 'Institute of Nursing Science and Practice, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Gottwald', 'Affiliation': 'CannaXan GmbH, Warngau, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Nistler', 'Affiliation': 'Apurano Pharmaceuticals GmbH, Warngau, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brehm', 'Affiliation': 'Apurano Pharmaceuticals GmbH, Warngau, Germany.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Grötsch', 'Affiliation': 'Gemeinschaftspraxis Dr. Grötsch & Dr. Heimer, Holzkirchen, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Haber', 'Affiliation': 'Department of Neurology, University Hospital Agatharied, Hausham, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bremm', 'Affiliation': 'Dürnbachstrasse 54a, Schliersee, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Weck', 'Affiliation': 'Institute of Nursing Science and Practice, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Trummer', 'Affiliation': 'CannaXan GmbH, Warngau, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Brand', 'Affiliation': 'CannaXan GmbH, Warngau, Germany.'}]",Medical cannabis and cannabinoids,['10.1159/000521352']
2736,35223947,Blue Zones-Based Worksite Nutrition Intervention: Positive Impact on Employee Wellbeing.,"""Blue Zones"" are geographical regions where people live to be non-agenarians and centenarians with significantly better rates of mental wellness when compared to the average American. It was discovered that these areas have nine unique evidenced-based lifestyle principles, with one of their main principles being the consumption of a plant-based diet. With this in mind, we performed a worksite intervention with the objective of understanding the relationships among Blue Zones knowledge, a plant-based lifestyle, and improvements in overall mental wellness during the COVID-19 pandemic. During spring 2021, we recruited 52 employees from a public, mid-sized university in the southwestern United States to participate in an 8-week virtual intervention that included weekly topic presentations, cooking demonstrations, and Blue Zones education. Participants were also assigned to weekly wellness counseling groups integrating Motivational Interviewing based principles that included additional, relevant conversation topics and support. The final sample ( n  = 52 participants) had a mean age of 45.6 ± 10.6 years. Participants were predominantly women (84.6%) and nearly half were married (44.2%). The majority attended graduate school (59.6%) and identified as White (84.6%). Paired-samples  t -tests indicated significant improvements in all mental wellness outcomes and Healthy Eating Index-2015 (HEI-2015) scores over time ( p's  < 0.001 to 0.02). Multiple linear regression models revealed that Blue Zones knowledge (β = -0.037,  p  = 0.010) significantly negatively predicted Patient Health Questionnaire-9 (PHQ-9) scores at 8-weeks. Additionally, multiple linear regression models indicated small group attendance (β = -1.51,  p  = 0.003) and Blue Zones knowledge (β = -0.81,  p  = 0.012) significantly negatively predicted sleep scores at 8-weeks. When HEI-2015 total scores were also included at baseline and 8-weeks (post-intervention), Blue Zones knowledge (β = -0.031,  p  = 0.049) was a borderline significant predictor of PHQ-9 at 8-weeks. Additionally, small group sessions (β = -1.52  p  = 0.005) were a significant predictor of sleep at 8-weeks. The intervention illustrated that virtual intervention strategies can improve nutrition and mental wellness for future advancement in life quality and wellbeing.",2022,t -tests indicated significant improvements in all mental wellness outcomes and Healthy Eating Index-2015 (HEI-2015) scores over time (,"['The final sample ( n  = 52 participants) had a mean age of 45.6 ± 10.6 years', 'During spring 2021, we recruited 52 employees from a public, mid-sized university in the southwestern United States to participate in an 8-week', 'Participants were predominantly women (84.6%) and nearly half were married (44.2']","['Blue Zones-Based Worksite Nutrition Intervention', 'virtual intervention that included weekly topic presentations, cooking demonstrations, and Blue Zones education', 'wellness counseling groups integrating Motivational Interviewing based principles that included additional, relevant conversation topics and support']","['sleep scores', 'mental wellness outcomes and Healthy Eating Index-2015 (HEI-2015) scores over time ', 'Employee Wellbeing', 'Patient Health Questionnaire-9 (PHQ-9) scores', 'overall mental wellness', 'Blue Zones knowledge']","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0555047', 'cui_str': 'Married'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237547', 'cui_str': 'Group counseling'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",52.0,0.0384404,t -tests indicated significant improvements in all mental wellness outcomes and Healthy Eating Index-2015 (HEI-2015) scores over time (,"[{'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'Heath', 'Affiliation': 'Department of Health Sciences, Northern Arizona University, Flagstaff, AZ, United States.'}, {'ForeName': 'Nanette V', 'Initials': 'NV', 'LastName': 'Lopez', 'Affiliation': 'Department of Health Sciences, Northern Arizona University, Flagstaff, AZ, United States.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Seeton', 'Affiliation': 'Department of Health Sciences, Northern Arizona University, Flagstaff, AZ, United States.'}, {'ForeName': 'Jay T', 'Initials': 'JT', 'LastName': 'Sutliffe', 'Affiliation': 'Department of Health Sciences, Northern Arizona University, Flagstaff, AZ, United States.'}]",Frontiers in nutrition,['10.3389/fnut.2022.795387']
2737,35223946,Carbohydrate Mouth-Rinsing Improves Overtime Physical Performance in Male Ice Hockey Players During On-Ice Scrimmages.,"Purpose


This randomized, double-blind, crossover study examined the effects of mouth-rinsing (MR) with a carbohydrate (CHO) vs. a placebo (PLA) solution on external and internal loads in hydrated ice hockey players during regulation and overtime (OT) periods of an on-ice scrimmage.
Methods


Twelve skilled male hockey players (22.6 [3.4] years, 178.9 [4.7] cm, 84.0 [6.5] kg) played three 20-min regulation periods and one 12-min OT period of small-sided 3-on-3 scrimmage. Skaters repeated 2 min shift and rest intervals. Participants mouth rinsed with 25 mL of CHO or PLA solution approximately every 10 min for a total of 7 rinses. A local positioning system (LPS) tracked external load variables including speed, distance, acceleration, and deceleration. Internal load was monitored with heart rate (HR) sensors and a rating of perceived exertion (RPE).
Results


During regulation play, both the conditions developed similar fatigue, with significantly decreased high-intensity distance, average speed and decelerations, and increased RPE, from period 1 to 2 and 3. In OT, CHO MR increased the distance skated at high-intensity (224 [77], 185 [66] m,  p  = 0.042), peak speed (24.6 [1.6], 23.7 [1.3] km·h -1 ,  p  = 0.016), number of sprints (1.9 [1.2], 1.2 [0.9],  p  = 0.011), and decreased distance skated at slow speed (300 [33], 336 [47],  p  = 0.034) vs. PLA MR. OT RPE was similar between the two conditions in spite of more work done in CHO MR.
Conclusions


CHO MR may be a valuable practice to protect against decrements in external load with increased playing time in ice hockey, and possibly allows athletes to perform more work relative to perceived levels of exertion.",2022,"During regulation play, both the conditions developed similar fatigue, with significantly decreased high-intensity distance, average speed and decelerations, and increased RPE, from period 1 to 2 and 3.","['Methods\n\n\nTwelve skilled male hockey players (22.6 [3.4] years, 178.9 [4.7] cm, 84.0 [6.5] kg) played three 20-min regulation periods and one 12-min OT period of small-sided 3-on-3 scrimmage', 'Male Ice Hockey Players']","['mouth-rinsing (MR) with a carbohydrate (CHO) vs. a placebo (PLA) solution', 'CHO or PLA solution', 'Carbohydrate Mouth-Rinsing']","['Overtime Physical Performance', 'speed, distance, acceleration, and deceleration', 'number of sprints', 'distance skated at slow speed', 'peak speed', 'high-intensity distance, average speed and decelerations, and increased RPE', 'heart rate (HR) sensors and a rating of perceived exertion (RPE']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0016074', 'cui_str': 'Field hockey'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C2961731', 'cui_str': 'Overtime'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0020748', 'cui_str': 'Ice hockey'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}]","[{'cui': 'C2961731', 'cui_str': 'Overtime'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037246', 'cui_str': 'Family Rajidae - skate'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]",12.0,0.148172,"During regulation play, both the conditions developed similar fatigue, with significantly decreased high-intensity distance, average speed and decelerations, and increased RPE, from period 1 to 2 and 3.","[{'ForeName': 'Danielle L E', 'Initials': 'DLE', 'LastName': 'Nyman', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'Alexander S D', 'Initials': 'ASD', 'LastName': 'Gamble', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Bigg', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'Logan A', 'Initials': 'LA', 'LastName': 'Boyd', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Vanderheyden', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}, {'ForeName': 'Lawrence L', 'Initials': 'LL', 'LastName': 'Spriet', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ON, Canada.'}]",Frontiers in nutrition,['10.3389/fnut.2022.792708']
2738,35223945,Examining the Role of Food Form on Children's Self-Regulation of Energy Intake.,"Increasing childhood obesity rates in both the United States and worldwide demonstrate a need for better prevention and intervention strategies. However, little is understood about what factors influence children's ability to sense and respond to hunger and fullness cues, a critical component of self-regulation of energy intake and maintenance of a healthy body weight. Research in adults suggests that food form may influence self-regulation of energy intake. More specifically, beverages are not as satiating as solid foods when matched for factors such as energy content, energy density, and volume and therefore elicit poorer energy intake self-regulation. However, much less is known about the impact of food form on children's ability to regulate their energy intake. This report describes a study that will examine the relationship between biological, cognitive, and psychological factors and children's appetite self-regulation (ASR). In this registered report, we will examine the influence of food form on children's short-term energy compensation, a proxy indicator of energy intake self-regulation. The study will employ a within-subjects, crossover design in which children ( n  = 78) ages 4.5-6 years will attend five laboratory visits, each ~1 week apart. During each visit, children will be presented with one of five possible preload conditions: apple slices, apple sauce, apple juice, apple juice sweetened with non-nutritive sweetener (NNS), or no preload. The order of preload conditions will be pseudorandomized and counterbalanced across participants. Following consumption of the preload (or no preload), children will consume a standardized  ad libitum  test meal of common foods for this age group. We hypothesize that children will demonstrate poorer short-term energy compensation (greater meal intake) in response to the liquid and semi-solid preloads compared to the solid preload. Understanding how energy in various forms affects children's ability to self-regulate intake has implications for dietary recommendations and will help identify those who are most at-risk for poor intake regulation and the development of obesity.",2022,"More specifically, beverages are not as satiating as solid foods when matched for factors such as energy content, energy density, and volume and therefore elicit poorer energy intake self-regulation.","['children ( n  = 78) ages 4.5-6 years will attend five laboratory visits, each ~1 week apart']","['apple sauce, apple juice, apple juice sweetened with non-nutritive sweetener (NNS), or no preload']","['childhood obesity rates', ""biological, cognitive, and psychological factors and children's appetite self-regulation (ASR""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0453357', 'cui_str': 'Sauce'}, {'cui': 'C0452454', 'cui_str': 'Apple juice'}, {'cui': 'C3658246', 'cui_str': 'High-Intensity Sweeteners'}]","[{'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",,0.0307375,"More specifically, beverages are not as satiating as solid foods when matched for factors such as energy content, energy density, and volume and therefore elicit poorer energy intake self-regulation.","[{'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Reigh', 'Affiliation': ""The Metabolic Kitchen and Children's Eating Behavior Laboratory, Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, United States.""}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Rolls', 'Affiliation': 'The Laboratory for the Study of Human Ingestive Behavior, Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, United States.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Francis', 'Affiliation': 'Center for Family Research in Diverse Contexts, Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Buss', 'Affiliation': 'The Emotion Development Laboratory, Departments of Psychology and Human Development and Family Studies, The Pennsylvania State University, University Park, PA, United States.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Hayes', 'Affiliation': 'Department of Food Science, Sensory Evaluation Center, The Pennsylvania State University, University Park, PA, United States.'}, {'ForeName': 'Marion M', 'Initials': 'MM', 'LastName': 'Hetherington', 'Affiliation': 'Human Appetite Research Unit, School of Psychology, Woodhouse, The University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Kameron J', 'Initials': 'KJ', 'LastName': 'Moding', 'Affiliation': 'Child Temperament and Health Laboratory, Department of Human Development and Family Studies, Purdue University, West Lafayette, IN, United States.'}, {'ForeName': 'Samantha M R', 'Initials': 'SMR', 'LastName': 'Kling', 'Affiliation': 'Evaluation Sciences Unit, Division of Primary Care Population Health, Department of Medicine, School of Medicine, Stanford University, Stanford, CA, United States.'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Keller', 'Affiliation': ""The Metabolic Kitchen and Children's Eating Behavior Laboratory, Departments of Nutritional Sciences and Food Science, The Pennsylvania State University, University Park, PA, United States.""}]",Frontiers in nutrition,['10.3389/fnut.2022.791718']
2739,35223910,Analgesic Efficacy of Spinal Morphine in Comparison With Transversus Abdominis Plane Block for Postoperative Pain Management in Patients Undergoing Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Trial.,"Background


Cesarean section (CS) has been one of the most frequently performed major surgical interventions and causes severe postoperative pain. Spinal opioid and abdominal field block have been investigated as effective analgesia for postoperative pain and reduce the need for systemic medications and associated side effects. The aim of the current study is to compare spinal morphine (SM) and bilateral landmark oriented transversus abdominis plane (TAP) block for postoperative pain management.
Method


In this randomized controlled trial, 114 pregnant mothers scheduled for CS under spinal anesthesia were allocated randomly to receive either SM 0.1 mg (group SM;  n  = 56) or bilateral landmark-oriented TAP block with 20 ml of 0.25% of bupivacaine (group TAP;  n  = 52). A comparison of numerical variables between study groups was done using unpaired student  t -test and Mann-Whitney test for symmetric and asymmetric data, respectively. Time to event variable was analyzed by using Kaplan-Meir's survival function. A  p -value of < 0.05 was considered statistically significant.
Result


A total of 114 patients were recruited and randomly assigned and received interventions. Among them, 108 patients completed this study. Time to first analgesic request was significantly shorter in the TAP block compared to SM. Twenty-four-hour median morphine consumption was reduced in the SM group compared to the TAP block ( p  < 0.001). Median postoperative pain score during movement and rest shows statistically significant differences between groups ( p  < 0.001).
Conclusion


The addition of preservative-free 100 μg SM provides prolonged postoperative analgesia time, superior postoperative analgesia, and less postoperative opioid consumption compared to the TAP block.",2022,Twenty-four-hour median morphine consumption was reduced in the SM group compared to the TAP block ( p  < 0.001).,"['114 pregnant mothers scheduled for CS under spinal anesthesia', 'Patients Undergoing Cesarean Section', 'Under Spinal Anesthesia', 'A total of 114 patients', '108 patients completed this study']","['\n\n\nCesarean section (CS', 'Transversus Abdominis Plane Block', 'Spinal Morphine', 'SM 0.1 mg (group SM;  n  = 56) or bilateral landmark-oriented TAP block with 20 ml of 0.25% of bupivacaine', 'spinal morphine (SM) and bilateral landmark oriented transversus abdominis plane (TAP) block']","['Median postoperative pain score', 'median morphine consumption', 'Analgesic Efficacy', 'postoperative analgesia time, superior postoperative analgesia, and less postoperative opioid consumption', 'Time to first analgesic request']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}]",114.0,0.201911,Twenty-four-hour median morphine consumption was reduced in the SM group compared to the TAP block ( p  < 0.001).,"[{'ForeName': 'Bedru', 'Initials': 'B', 'LastName': 'Jemal', 'Affiliation': 'Department of Anesthesiology, College of Health Sciences and Medicine, Dilla University, Dilla, Ethiopia.'}, {'ForeName': 'Fetiha', 'Initials': 'F', 'LastName': 'Mohammed', 'Affiliation': 'Department of Anesthesiology, College of Health Sciences and Medicine, Hawasa University, Dilla, Ethiopia.'}, {'ForeName': 'Hailemariam Getachew', 'Initials': 'HG', 'LastName': 'Tesema', 'Affiliation': 'Department of Anesthesiology, College of Health Sciences and Medicine, Dilla University, Dilla, Ethiopia.'}, {'ForeName': 'Siraj', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Department of Anesthesiology, College of Health Sciences and Medicine, Dilla University, Dilla, Ethiopia.'}, {'ForeName': 'Ayub', 'Initials': 'A', 'LastName': 'Mohammed', 'Affiliation': 'Department of Anesthesia, College of Medicine and Health Science, Wollo University, Dessie, Ethiopia.'}, {'ForeName': 'Teshome', 'Initials': 'T', 'LastName': 'Regasa', 'Affiliation': 'Department of Anesthesiology, College of Health Sciences and Medicine, Dilla University, Dilla, Ethiopia.'}, {'ForeName': 'Mohammed Suleiman', 'Initials': 'MS', 'LastName': 'Obsa', 'Affiliation': 'Department of Anesthesiology, College of Health Sciences and Medicine, Woliata Sodo University, Dilla, Ethiopia.'}]",Frontiers in medicine,['10.3389/fmed.2022.814538']
2740,35224222,"Effects of oral administration of equine placental extract supplement on the facial skin of healthy adult women: A randomized, double-blind, placebo-controlled study.","Introduction


Placenta extract is used as an ingredient in ointments for treating dermatological diseases, skin dryness, and for skin beautification. However, the clinical effects of the equine placenta on humans and the underlying mechanism of action are unclear. This randomized, controlled, double-blind study aimed to clinically evaluate the effect of oral intake of equine placental extract on human skin quality.
Methods


Healthy women volunteers between the ages of 30 and 59 years (n = 29) were randomly assigned to receive 220 mg of equine placental extract-placebo orally, once daily for 4 weeks. Skin quality parameters such as skin hydration, skin barrier function (transepidermal water loss [TEWL]), and melanin index were assessed at baseline and after 4 weeks of administration.
Results


The melanin index was significantly increased in the placebo group, whereas it remained unchanged in the equine placenta group. The pattern of melanin index change was significantly different due to intake or no intake of equine placenta supplements over 4 weeks. No significant difference was found in skin hydration and TEWL between the two groups at 4 weeks of postadministration. It was shown that the intake of the equine placenta was more effective in protecting the skin condition against the change of ultraviolet (UV) sensitively than the change in temperature and humidity.
Conclusions


Effect of equine placental extract intake was evident on the cheek skin of the equine placenta group where participants were protected from UV-induced pigmentation. Equine placental extract is useful for decreasing melanin synthesis and melanin content in the human skin and can be used as an effective food supplement to maintain human skin quality.",2022,No significant difference was found in skin hydration and TEWL between the two groups at 4 weeks of postadministration.,"['Healthy women volunteers between the ages of 30 and 59\u2009years (n\xa0=\xa029', 'healthy adult women']","['placebo', 'equine placental extract supplement', '220\u2009mg of equine placental extract-placebo', 'equine placental extract intake', 'Equine placental extract', 'equine placental extract']","['skin hydration and TEWL', 'human skin quality', 'melanin index change', 'Skin quality parameters such as skin hydration, skin barrier function (transepidermal water loss [TEWL]), and melanin index', 'melanin index', 'cheek skin']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0032048', 'cui_str': 'Placental Extracts'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C3859811', 'cui_str': 'human skin preparation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0222085', 'cui_str': 'Skin structure of cheek'}]",29.0,0.105484,No significant difference was found in skin hydration and TEWL between the two groups at 4 weeks of postadministration.,"[{'ForeName': 'Masumi', 'Initials': 'M', 'LastName': 'Nagae', 'Affiliation': 'Department of Agro-Environmental Sciences, Laboratory of Systematic Forest and Forest Products Sciences, Faculty of Agriculture Graduate School of Kyushu University Fukuoka Japan.'}, {'ForeName': 'Tomoe', 'Initials': 'T', 'LastName': 'Nishio', 'Affiliation': 'Dr. Prolabo Japan Co., Ltd Tokyo Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Ohnuki', 'Affiliation': 'Department of Biological and Environmental Chemistry Kinki University Kyushu Izuka Japan.'}, {'ForeName': 'Kuniyoshi', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': 'Department of Agro-Environmental Sciences, Laboratory of Systematic Forest and Forest Products Sciences, Faculty of Agriculture Graduate School of Kyushu University Fukuoka Japan.'}]",Health science reports,['10.1002/hsr2.522']
2741,35224215,Effect of vaginal washing before Misoprostol insertion on cervical ripening before induction of labor: A randomized single-blind clinical trial.,"Background


Vaginal pH is acidic in pregnancy, but there is no information about pH changes in pregnancy, and contradictory results have been reported from the effectiveness of Misoprostol at different vaginal pH. This study aimed to evaluate the effect of vaginal washing before Misoprostol insertion on cervical ripening before induction of labor in comparison with the control group.
Methods


This randomized single-blind clinical trial was performed on 148 pregnant women who were candidates for induction of labor. Subjects were randomly divided into two groups of intervention (vaginal washing with 20 cc of normal saline 0.9% before Misoprostol insertion) and the control group (without vaginal washing). Vaginal pH and Bishop scores were measured before and after the intervention. The two groups were compared in demographic-obstetric variables, the success rate of induction of labor, maternal and neonatal outcomes, and Misoprostol dose.
Results


After the intervention, there was no statistically significant difference between the pH before and after in the group with vaginal washing. There was no significant difference between the two groups in the type and duration of labor, and maternal and neonatal outcomes ( P  > .05). The frequency of normal delivery less than 12 hours in the intervention group was higher than in the control group. Although this difference was not statistically significant due to the small number of subjects, it is clinically significant.
Conclusion


The results of the present study showed that vaginal washing with normal saline before Misoprostol insertion for induction of labor did not affect the success of induction and duration of labor.",2022,"There was no significant difference between the two groups in the type and duration of labor, and maternal and neonatal outcomes ( P  > .05).","['148 pregnant women who were candidates for induction of labor', 'cervical ripening before induction of labor']","['intervention (vaginal washing with 20\u2009cc of normal saline 0.9% before Misoprostol insertion) and the control group (without vaginal washing', 'vaginal washing before Misoprostol insertion', 'Misoprostol']","['success rate of induction of labor, maternal and neonatal outcomes, and Misoprostol dose', 'type and duration of labor, and maternal and neonatal outcomes', 'success of induction and duration of labor', 'frequency of normal delivery less', 'Vaginal pH and Bishop scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0600454', 'cui_str': 'Cervical Ripening'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}]",148.0,0.026884,"There was no significant difference between the two groups in the type and duration of labor, and maternal and neonatal outcomes ( P  > .05).","[{'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Kabodmehri', 'Affiliation': 'Reproductive Health Research Center, Department of Obstetrics and Gynecology, Al-Zahra Hospital, School of Medicine Guilan University of Medical Sciences Rasht Iran.'}, {'ForeName': 'Seyedeh Hajar', 'Initials': 'SH', 'LastName': 'Sharami', 'Affiliation': 'Reproductive Health Research Center, Department of Obstetrics and Gynecology, Al-Zahra Hospital, School of Medicine Guilan University of Medical Sciences Rasht Iran.'}, {'ForeName': 'Forozan', 'Initials': 'F', 'LastName': 'Milani', 'Affiliation': 'Reproductive Health Research Center, Department of Obstetrics and Gynecology, Al-Zahra Hospital, School of Medicine Guilan University of Medical Sciences Rasht Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hosseinzadeh', 'Affiliation': 'Reproductive Health Research Center, Department of Obstetrics and Gynecology, Al-Zahra Hospital, School of Medicine Guilan University of Medical Sciences Rasht Iran.'}, {'ForeName': 'Seyedeh Fatemeh', 'Initials': 'SF', 'LastName': 'Dalil Heirati', 'Affiliation': 'Reproductive Health Research Center, Department of Obstetrics and Gynecology, Al-Zahra Hospital, School of Medicine Guilan University of Medical Sciences Rasht Iran.'}, {'ForeName': 'Zakie', 'Initials': 'Z', 'LastName': 'Bakhshipour', 'Affiliation': 'Reproductive Health Research Center, Department of Obstetrics and Gynecology, Al-Zahra Hospital, School of Medicine Guilan University of Medical Sciences Rasht Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Pourhabibi', 'Affiliation': 'Vice-Chancellorship of Research and Technology Guilan University of Medical Science Rasht Iran.'}]",Health science reports,['10.1002/hsr2.502']
2742,35224208,Using the Mothers Object Relations Scale for early childhood development research in rural India: Findings from the Early Life Stress Sub-study of the SPRING Cluster Randomised Controlled Trial (SPRING-ELS).,"Background:  The World Health Organization and others promote responsive caregiving to support all children to thrive, particularly in low- and middle-income countries. The 14-item Mother's Object Relations Scales - Short Form (MORS-SF) may be of use in research and public health programmes because of its basis in attachment theory and ability to capture parental feelings towards their child.  Methods:  We culturally adapted the MORS-SF for use with mothers in the SPRING home visits trial when their infants were 12 months old. The same dyads were assessed using the HOME inventory concurrently and Bayley Scales of Infant Development III (BSID-III) at 18 months of age. Mixed effects linear regression was used to examine associations between MORS-SF (explanatory variable) and HOME-IT, and the cognitive, language and motor domains of BSID-III (outcome variables).  Results:  1273 dyads completed all assessments. For the motor and language BSID-III scales and for HOME-IT there were strong and positive associations with the MORS-SF warmth sub-scale, and strong and negative associations with the invasion sub-scale. Important but less strong associations were seen with the BSID-III cognitive scale. Evidence of interaction suggested that both are individually important for child development.  Conclusions:  This is the first time MORS-SF has been used in India where optimising responsive caregiving is of importance in supporting all children to reach their potential. It is also the first time that the tool has been used in relation to child development. MORS-SF could be a valuable addition to evaluation in early childhood development.",2021,"For the motor and language BSID-III scales and for HOME-IT there were strong and positive associations with the MORS-SF warmth sub-scale, and strong and negative associations with the invasion sub-scale.","['rural India', '1273 dyads completed all assessments']",[],"['BSID-III cognitive scale', 'HOME inventory concurrently and Bayley Scales of Infant Development III (BSID-III', 'motor and language BSID-III scales', 'MORS-SF (explanatory variable) and HOME-IT, and the cognitive, language and motor domains of BSID-III (outcome variables']","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",[],"[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C1138348', 'cui_str': 'moira protein, Drosophila'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1273.0,0.0634637,"For the motor and language BSID-III scales and for HOME-IT there were strong and positive associations with the MORS-SF warmth sub-scale, and strong and negative associations with the invasion sub-scale.","[{'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Bhopal', 'Affiliation': 'Population Health Sciences Institute, Newcatle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Reetabrata', 'Initials': 'R', 'LastName': 'Roy', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Deepali', 'Initials': 'D', 'LastName': 'Verma', 'Affiliation': 'Sangath, New Delhi, India.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Bushra', 'Initials': 'B', 'LastName': 'Khan', 'Affiliation': 'Department of Psychology, University of Karachi, Karachi, Pakistan.'}, {'ForeName': 'Seyi', 'Initials': 'S', 'LastName': 'Soremekun', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Oates', 'Affiliation': 'Faculty of Wellbeing, Education & Language Studies, Open University, Milton Keynes, UK.'}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Divan', 'Affiliation': 'Sangath, New Delhi, India.'}, {'ForeName': 'Betty R', 'Initials': 'BR', 'LastName': 'Kirkwood', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}]",Wellcome open research,['10.12688/wellcomeopenres.16591.2']
2743,35224097,Application Values of 2D and 3D Radiomics Models Based on CT Plain Scan in Differentiating Benign from Malignant Ovarian Tumors.,"Background


Accurate identification of ovarian tumors as benign or malignant is highly crucial. Radiomics is a new branch of imaging that has emerged in recent years to replace the traditional naked eye qualitative diagnosis.
Objective


This study is aimed at exploring the difference in the application potential of two- (2D) and three-dimensional (3D) radiomics models based on CT plain scan in differentiating benign from malignant ovarian tumors.
Method


A retrospective analysis was performed on 140 patients with ovarian tumors confirmed by surgery and pathology in our hospital from July 2017 to August 2020. These 140 patients were divided into benign group and malignant group according to the pathological results. The ITK-SNAP software was used to outline the regions-of-interest (ROI) of 2D or 3D tumors on the CT plain scan image of each patient; the texture features were extracted through analysis kit (AK), and the cases were randomly divided into training groups ( n  = 99) and validation group ( n  = 41) in a ratio of 7 : 3. The least absolute shrinkage and selection operator (LASSO) algorithm was used to perform dimensionality reduction, followed by the construction of the radiomics nomogram model using the logistic regression method. The receiver operating characteristic (ROC) curve was drawn, and the calibration curve and decision curve analysis (DCA) were used to evaluate and verify the results of the radiomics nomogram and compare the differences between 2D and 3D diagnostic performance.
Results


There were 396 quantitative radiomics feature parameters extracted from 2D group and the 3D group, respectively. The area under the curve (AUC) of the radiomics nomogram of the 2D training group and the validation group were 0.96 and 0.97, respectively. The accuracy, specificity, and sensitivity of the training set were 92.9%, 88.9%, and 96.3%, respectively, and those of the validation set were 90.2%, 82.6%, and 100.0%, respectively. The AUCs of the radiomics nomogram of the 3D training group and validation group were 0.96% and 0.99%, respectively. The accuracy, sensitivity, and specificity of the training set were 92.9%, 96.3%, and 88.9%, respectively, and those of the validation set were 97.6%, 95.7%, and 100.0%, respectively. DeLong's test indicated that there was no statistical significance between the two sets ( P  > 0.05).
Conclusions


For the differential diagnosis of benign and malignant ovarian tumors, the 2D and 3D radiomics nomogram models exhibited comparable diagnostic performance. Considering that the 2D model was cost-effective and time-efficient, it was more recommended to use 2D features in future research.",2022,"DeLong's test indicated that there was no statistical significance between the two sets ( P  > 0.05).
","['140 patients with ovarian tumors confirmed by surgery and pathology in our hospital from July 2017 to August 2020', '140 patients were divided into benign group and malignant group according to the pathological results', 'Differentiating Benign from Malignant Ovarian Tumors']","['CT Plain Scan', '2D) and three-dimensional (3D) radiomics models based on CT plain scan']","['least absolute shrinkage and selection operator (LASSO', 'area under the curve (AUC', 'receiver operating characteristic (ROC) curve', 'accuracy, sensitivity, and specificity of the training set', 'accuracy, specificity, and sensitivity of the training set', 'diagnostic performance']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C1140680', 'cui_str': 'Malignant tumor of ovary'}]","[{'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",140.0,0.0267438,"DeLong's test indicated that there was no statistical significance between the two sets ( P  > 0.05).
","[{'ForeName': 'Shiyun', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Gynecology, Jiangxi Provincial People's Hospital, The First Affiliated Hospital of Nanchang Medical College, Nanchang 330006, China.""}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, Jiangxi Provincial People's Hospital, The First Affiliated Hospital of Nanchang Medical College, Nanchang 330006, China.""}, {'ForeName': 'Yuanhuan', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': ""Department of Gynecology, Jiangxi Provincial People's Hospital, The First Affiliated Hospital of Nanchang Medical College, Nanchang 330006, China.""}, {'ForeName': 'Yongzhi', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Gynecology, Jiangxi Provincial People's Hospital, The First Affiliated Hospital of Nanchang Medical College, Nanchang 330006, China.""}, {'ForeName': 'Peipei', 'Initials': 'P', 'LastName': 'Pang', 'Affiliation': 'GE Healthcare, Hangzhou 310000, China.'}, {'ForeName': 'Puying', 'Initials': 'P', 'LastName': 'Luo', 'Affiliation': ""Department of Gynecology, Jiangxi Provincial People's Hospital, The First Affiliated Hospital of Nanchang Medical College, Nanchang 330006, China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': ""Department of Radiology, Jiangxi Provincial People's Hospital, The First Affiliated Hospital of Nanchang Medical College, Nanchang 330006, China.""}]",BioMed research international,['10.1155/2022/5952296']
2744,35224710,"The Effect of Selenium Supplementation on Clinical Outcomes, Metabolic Profiles, and Pulsatility Index of the Uterine Artery in High-Risk Mothers in Terms of Preeclampsia Screening with Quadruple Test: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial : Selenium and preeclampsia.","Data on the effects of selenium (Se) supplementation on clinical outcomes, metabolic profiles, and pulsatility index (PI) in high-risk mothers in terms of preeclampsia (PE) screening with quadruple tests are scarce. This study evaluated the effects of Se supplementation on clinical outcomes, metabolic profiles, and uterine artery PI on Doppler ultrasound in high-risk mothers in terms of PE screening with quad marker. The current randomized, double-blind, placebo-controlled trial was conducted among 60 high-risk pregnant women screening for PE with quad tests. Participants were randomly allocated into two groups (30 participants each group), received either 200 µg/day Se supplements (as Se amino acid chelate) or placebo from 16 to 18 weeks of pregnancy for 12 weeks. Clinical outcomes, metabolic profiles, and uterine artery PI were assessed at baseline and at the end of trial. Se supplementation resulted in a significant elevation in serum Se levels (β 22.25 µg/dl; 95% CI, 18.3, 26.1; P < 0.001) compared with the placebo. Also, Se supplementation resulted in a significant elevation in total antioxidant capacity (β 82.88 mmol/L; 95% CI, 3.03, 162.73; P = 0.04), and total glutathione (β 71.35 µmol/L; 95% CI, 5.76, 136.94; P = 0.03), and a significant reduction in high-sensitivity C-reactive protein levels (β - 1.52; 95% CI, - 2.91, - 0.14; P = 0.03) compared with the placebo. Additionally, Se supplementation significantly decreased PI of the uterine artery in Doppler ultrasound (β - 0.09; 95% CI, - 0.14, - 0.04; P = 0.04), and a significant improvement in depression (β - 5.63; 95% CI, - 6.97, - 4.28; P < 0.001), anxiety (β - 1.99; 95% CI, - 2.56, - 1.42; P < 0.001), and sleep quality (β - 1.97; 95% CI, - 2.47, - 1.46; P < 0.001). Se supplementation for 12 weeks in high-risk pregnant women in terms of PE screening with quad marker had beneficial effects on serum Se level, some metabolic profiles, uterine artery PI, and mental health. IRCT Registration: htpp:// www.irct.ir ; identifier IRCT20200608047701N1.",2022,"Se supplementation resulted in a significant elevation in serum Se levels (β 22.25 µg/dl; 95% CI, 18.3, 26.1; P < 0.001) compared with the placebo.","['High-Risk Mothers in Terms of Preeclampsia', 'high-risk mothers in terms of PE screening with quad marker', '60 high-risk pregnant women screening for PE with quad tests']","['selenium (Se) supplementation', 'placebo', 'Placebo', '200\xa0µg/day Se supplements (as Se amino acid chelate) or placebo', 'Selenium Supplementation', 'IRCT Registration', 'Se supplementation', 'Quadruple Test']","['sleep quality', 'total antioxidant capacity', 'depression', 'clinical outcomes, metabolic profiles, and pulsatility index (PI', 'anxiety', 'Clinical outcomes, metabolic profiles, and uterine artery PI', 'Clinical Outcomes, Metabolic Profiles, and Pulsatility Index of the Uterine Artery', 'serum Se level, some metabolic profiles, uterine artery PI, and mental health', 'total glutathione', 'serum Se levels', 'PI of the uterine artery in Doppler ultrasound', 'high-sensitivity C-reactive protein levels', 'clinical outcomes, metabolic profiles, and uterine artery PI on Doppler ultrasound']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4042790', 'cui_str': 'Quad'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521939', 'cui_str': 'Selenium supplement'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0007974', 'cui_str': 'Chelating agent'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0455308', 'cui_str': 'Serum selenium measurement'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}]",,0.605248,"Se supplementation resulted in a significant elevation in serum Se levels (β 22.25 µg/dl; 95% CI, 18.3, 26.1; P < 0.001) compared with the placebo.","[{'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Mesdaghinia', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Shahin', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran. Farahshahin660@yahoo.com.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Addiction Studies, School of Medicine AND Clinical Research Development Unit, Matini/Kargarnejad Hospital, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Daryoush', 'Initials': 'D', 'LastName': 'Shahin', 'Affiliation': 'Amelia Heart AND Vascular Center, Springfield, VA, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Shariat', 'Affiliation': 'Department of Pathology and Histology, Laboratory of Dr. Shariat, Kashan, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Banafshe', 'Affiliation': 'Department of Pharmacology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}]",Biological trace element research,['10.1007/s12011-022-03178-7']
2745,35224682,How does treadmill training contribute to botulinum toxin application plus routine physical therapy in ambulatory children with spastic bilateral cerebral palsy? A randomized controlled trial.,"BACKGROUND


In spite of treadmill training and multilevel botulinum toxin (BoNT-A) injection being the two most commonly used treatment methods in pediatric rehabilitation management, there was no study investigating the effect of treadmill training after BoNT-A injection in children with cerebral palsy (CP).
AIM


The aim of this study was to investigate the effect of treadmill training in addition to routine physical therapy after BoNT-A injection in ambulatory children with spastic bilateral CP on lower extremity muscle strength, selective motor control, and mobility.
METHODS


A total of 30 spastic bilateral children with CP classified level II-III by the Gross Motor Function Classification System were randomly assigned the study and control groups. Both groups continued routine physical therapy treatments after multilevel BoNT-A injection into lower extremities, while the study group additionally underwent 8 weeks of treadmill training (20 min, two sessions per week). Handheld dynamometer, selective control assessment of lower extremity, temporospatial evaluation of gait, and Pediatric Evaluation of Disability Inventory were assessed before and after 8 weeks.
RESULTS


In both groups, hip, knee, and ankle muscle strength increased at the end of 8 weeks (p < 0.05); however, in the study group, hip flexor/extensor muscle strength (p < 0.05, ES ≥ 0.50), selective motor control of ankle (p < 0.01, ES = 1.17), walking speed (p < 0.01, ES = 2.60), step lengths (p < 0.01, ES = 1.32), and mobility (p < 0.01, ES = 1.37) increased significantly compared to those of the control group.
CONCLUSIONS


Treadmill training in addition to routine physical therapy after BoNT-A injection is beneficial for hip muscle strength, ankle selective motor control, walking quality, and functional mobility in the short term.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03580174.",2022,"In both groups, hip, knee, and ankle muscle strength increased at the end of 8 weeks (p < 0.05); however, in the study group, hip flexor/extensor muscle strength (p < 0.05, ES ≥ 0.50), selective motor control of ankle (p < 0.01, ES = 1.17), walking speed (p < 0.01, ES = 2.60), step lengths (p < 0.01, ES = 1.32), and mobility (p < 0.01, ES = 1.37) increased significantly compared to those of the control group.
","['ambulatory children with spastic bilateral cerebral palsy', '30 spastic bilateral children with CP classified level II-III by the Gross Motor Function Classification System', 'children with cerebral palsy (CP', 'ambulatory children with spastic bilateral CP on lower extremity muscle strength, selective motor control, and mobility']","['botulinum toxin application plus routine physical therapy', 'treadmill training after BoNT', 'treadmill training and multilevel botulinum toxin (BoNT-A) injection', 'treadmill training', 'Treadmill training']","['selective motor control of ankle', 'Handheld dynamometer, selective control assessment of lower extremity, temporospatial evaluation of gait, and Pediatric Evaluation of Disability Inventory', 'hip flexor/extensor muscle strength', 'hip, knee, and ankle muscle strength', 'walking speed', 'mobility', 'hip muscle strength, ankle selective motor control, walking quality, and functional mobility']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C3838784', 'cui_str': 'Bilateral cerebral palsy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441926', 'cui_str': 'Level II'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",30.0,0.0123296,"In both groups, hip, knee, and ankle muscle strength increased at the end of 8 weeks (p < 0.05); however, in the study group, hip flexor/extensor muscle strength (p < 0.05, ES ≥ 0.50), selective motor control of ankle (p < 0.01, ES = 1.17), walking speed (p < 0.01, ES = 2.60), step lengths (p < 0.01, ES = 1.32), and mobility (p < 0.01, ES = 1.37) increased significantly compared to those of the control group.
","[{'ForeName': 'Kübra Seyhan', 'Initials': 'KS', 'LastName': 'Bıyık', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Sıhhıye, 06100, Ankara, Turkey. kubra.seyhan@yahoo.com.'}, {'ForeName': 'Mintaze Kerem', 'Initials': 'MK', 'LastName': 'Günel', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Sıhhıye, 06100, Ankara, Turkey.'}, {'ForeName': 'Ece Ünlü', 'Initials': 'EÜ', 'LastName': 'Akyüz', 'Affiliation': 'Clinic of Physical Medicine and Rehabilitation, University of Health Sciences Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}]",Irish journal of medical science,['10.1007/s11845-022-02960-9']
2746,35224588,A study protocol for a randomised controlled trial of ice to reduce the pain of immunisation: The ICE trial.,"BACKGROUND AND OBJECTIVES


Vaccine injections commonly cause iatrogenic pain. Ice may reduce pain. This is a study protocol for a prospective randomised controlled trial aiming to investigate the efficacy of ice packs to decrease vaccine-related pain in adults.
METHOD


The intervention group (n = 45) will receive ice packs (0 °C) and the control group (n = 45) receive placebo cold packs (10 °C) on the injection site for 30 seconds prior to vaccination.
RESULTS


The primary outcomes will test the hypothesis that applying an ice pack will significantly reduce pain of vaccination when compared with a cold pack. The primary dependent variable will be pain score recorded on a visual analogue scale. Secondary outcomes aim to assess potential adverse reactions. The main analysis of data will follow the intention-to-treat principle. The primary dependent variable will be compared using an independent t-test or a Mann-Whitney U test. Multivariable logistic regression analysis may be used.
DISCUSSION


The trial may guide general practitioners in the use of ice packs to reduce injection-related pain in adults.",2022,"This is a study protocol for a prospective randomised controlled trial aiming to investigate the efficacy of ice packs to decrease vaccine-related pain in adults.
",['adults'],"['placebo cold packs', 'ice packs (0', 'ice packs']","['pain', 'potential adverse reactions', 'pain of vaccination', 'pain score', 'visual analogue scale', 'pain of immunisation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0180006', 'cui_str': 'Cold pack'}, {'cui': 'C0181264', 'cui_str': 'Ice bag'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}]",45.0,0.713718,"This is a study protocol for a prospective randomised controlled trial aiming to investigate the efficacy of ice packs to decrease vaccine-related pain in adults.
","[{'ForeName': 'Yashodha', 'Initials': 'Y', 'LastName': 'Ediriweera', 'Affiliation': 'MBBS (Hons), Resident Medical Officer, Royal Brisbane and Women@s Hospital, Brisbane, Qld.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Banks', 'Affiliation': 'PhD, Senior Research Support, James Cook University, Qld. jennifer.banks2@jcu.edu.au.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Hall', 'Affiliation': 'PhD, Senior Research Officer, Mackay Clinical School, College of Medicine and Dentistry, James Cook University, Mackay, Qld@.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Heal', 'Affiliation': 'MBChB, DRANZCOG, DipGUMed, FRACGP, MPHTM, PhD, Promotional Chair, Discipline of General Practice and Rural Medicine, Mackay Clinical School, James Cook University College of Medicine and Dentistry, Mackay, Qld.'}]",Australian journal of general practice,['10.31128/AJGP-02-21-5838']
2747,35224551,A pilot mixed-methods randomized controlled trial of verbal versus electronic screening for adverse social determinants of health.,"Objectives


Examining the social risks that influence the health of patients accessing emergency care can inform future efforts to improve health outcomes. The optimal modality for screening in the emergency department (ED) has not yet been identified. We conducted a mixed methods evaluation of the impact of screening modality on patient satisfaction with the screening process.
Methods


Patients were enrolled at a large urban academic ED and randomized to verbal versus electronic modalities following informed consent. Participants completed a short demographic survey, a brief validated health literacy test, and a social need and risk screening tool. Participants were purposively sampled to complete qualitative interviews balanced across 4 groups defined by health literacy scores (high vs limited) and screening modality. Quantitative outcomes included screening results and satisfaction with the screening process; qualitative questions focused on experience with the screening process, barriers, and facilitators to screening.
Results


Of 554 patients assessed, 236 were randomized (115 verbal, 121 electronic). Participants were 23% Hispanic, 6% non-Hispanic Black, 58% non-Hispanic White, 38% publicly insured, and 57% privately insured. Two-thirds (67%) identified social needs and risks and the majority (81%) reported satisfaction with the screening. Screening modality was not associated with satisfaction with screening process after adjustment for language, health literacy, and social risk (adjusted odds ratio, 0.74; 95% confidence interval, 0.32, 1.71).
Conclusion


Screening modality was not associated with overall satisfaction with screening process. Future strategies can consider the advantage of multimodal screening options, including the use of electronic tools to streamline screening and expand scalability and sustainability.",2022,"Screening modality was not associated with satisfaction with screening process after adjustment for language, health literacy, and social risk (adjusted odds ratio, 0.74; 95% confidence interval, 0.32, 1.71).
","['Participants completed a short demographic survey, a brief validated health literacy test, and a social need and risk screening tool', 'adverse social determinants of health', 'Participants were 23% Hispanic, 6% non-Hispanic Black, 58% non-Hispanic White, 38% publicly insured, and 57% privately insured', 'Methods\n\n\nPatients were enrolled at a large urban academic ED', '554 patients assessed, 236 were randomized (115 verbal, 121 electronic']",['verbal versus electronic screening'],"['health literacy scores', 'language, health literacy, and social risk', 'experience with the screening process, barriers, and facilitators to screening']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0011296', 'cui_str': 'Demographic Survey'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C3658315', 'cui_str': 'Social Determinants of Health'}, {'cui': 'C0618884', 'cui_str': 'IS 23'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",236.0,0.148367,"Screening modality was not associated with satisfaction with screening process after adjustment for language, health literacy, and social risk (adjusted odds ratio, 0.74; 95% confidence interval, 0.32, 1.71).
","[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Macias-Konstantopoulos', 'Affiliation': 'Department of Emergency Medicine Massachusetts General Hospital Boston Massachusetts USA.'}, {'ForeName': 'Gia', 'Initials': 'G', 'LastName': 'Ciccolo', 'Affiliation': 'Department of Emergency Medicine Massachusetts General Hospital Boston Massachusetts USA.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Muzikansky', 'Affiliation': 'Biostatistics Center, Division of Clinical Research, Mass General Research Institute Massachusetts General Hospital Boston Massachusetts USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Samuels-Kalow', 'Affiliation': 'Department of Emergency Medicine Massachusetts General Hospital Boston Massachusetts USA.'}]",Journal of the American College of Emergency Physicians open,['10.1002/emp2.12678']
2748,35224881,Strategies to promote responsive bottle-feeding in WIC predict less frequent use of food to soothe and healthier weight status for infants with negative temperaments.,"BACKGROUND


Infants with greater temperamental negative affectivity are at higher risk for overfeeding and excess weight gain.
OBJECTIVE


To examine whether strategies to promote responsive bottle-feeding within WIC promoted healthier maternal feeding practices and infant weight status among infants with greater negative affectivity.
METHODS


Secondary analysis of data from a matched-pair cluster randomized trial. Policy, systems and environmental change (PSE) strategies to promote responsive bottle-feeding were implemented at three WIC clinics; these clinics were compared with three matched control clinics. Linear mixed models tested whether infant negative affectivity interacted with PSE strategies to predict feeding and weight outcomes when infants were 4-6 months old.
RESULTS


Significant interactions between infant negative affectivity and PSE strategies were noted. Among infants with high negative affectivity, mothers in PSE clinics reported less frequent use of food to soothe (p = 0.009) compared with mothers in control clinics. Among infants with moderate (p = 0.008) or high (p = 0.029) negative affectivity, infants in PSE clinics had healthier weight status compared with infants in control clinics.
CONCLUSIONS


Promotion of responsive bottle-feeding is an effective way to support WIC mothers and reduce risk for overfeeding and excess weight gain, particularly for mothers of infants with greater negative affectivity.",2022,"Among infants with moderate (p = 0.008) or high (p = 0.029) negative affectivity, infants in PSE clinics had healthier weight status compared with infants in control clinics.
","['infants with negative temperaments', 'infants with greater negative affectivity']",[],"['feeding and weight outcomes', 'healthier weight status']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0300549,"Among infants with moderate (p = 0.008) or high (p = 0.029) negative affectivity, infants in PSE clinics had healthier weight status compared with infants in control clinics.
","[{'ForeName': 'Alison K', 'Initials': 'AK', 'LastName': 'Ventura', 'Affiliation': 'Department of Kinesiology and Public Health, Center for Health Research, California Polytechnic State University, San Luis Obispo, California, USA.'}, {'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'Whaley', 'Affiliation': 'Division of Research and Evaluation, Public Health Foundation Enterprises WIC Program, Irwindale, California, USA.'}]",Pediatric obesity,['10.1111/ijpo.12908']
2749,35224810,Digital cognitive behaviour therapy for insomnia (dCBT-I): Chronotype moderation on intervention outcomes.,"Using data from 1721 participants in a community-based randomized control trial of digital cognitive behavioural therapy for insomnia compared with patient education, we employed linear mixed modelling analyses to examine whether chronotype moderated the benefits of digital cognitive behavioural therapy for insomnia on self-reported levels of insomnia severity, fatigue and psychological distress. Baseline self-ratings on the reduced version of the Horne-Östberg Morningness-Eveningness Questionnaire were used to categorize the sample into three chronotypes: morning type (n = 345; 20%); intermediate type (n = 843; 49%); and evening type (n = 524; 30%). Insomnia Severity Index, Chalder Fatigue Questionnaire, and Hospital Anxiety and Depression Scale were assessed pre- and post-intervention (9 weeks). For individuals with self-reported morning or intermediate chronotypes, digital cognitive behavioural therapy for insomnia was superior to patient education on all ratings (Insomnia Severity Index, Chalder Fatigue Questionnaire, and Hospital Anxiety and Depression Scale) at follow-up (p-values ≤ 0.05). For individuals with self-reported evening chronotype, digital cognitive behavioural therapy for insomnia was superior to patient education for Insomnia Severity Index and Chalder Fatigue Questionnaire, but not on the Hospital Anxiety and Depression Scale (p = 0.139). There were significant differences in the treatment effects between the three chronotypes on the Insomnia Severity Index (p = 0.023) estimated difference between evening and morning type of -1.70, 95% confidence interval: -2.96 to -0.45, p = 0.008, and estimated difference between evening and intermediate type -1.53, 95% confidence interval: -3.04 to -0.03, p = 0.046. There were no significant differences in the treatment effects between the three chronotypes on the Chalder Fatigue Questionnaire (p = 0.488) or the Hospital Anxiety and Depression Scale (p = 0.536). We conclude that self-reported chronotype moderates the effects of digital cognitive behavioural therapy for insomnia on insomnia severity, but not on psychological distress or fatigue.",2022,"For individuals with self-reported evening chronotype, digital cognitive behavioural therapy for insomnia was superior to patient education for Insomnia Severity Index and Chalder Fatigue Questionnaire, but not on the Hospital Anxiety and Depression Scale (p = 0.139).","['1721 participants in a community', 'insomnia (dCBT-I']","['Digital cognitive behaviour therapy', 'digital cognitive behavioural therapy', 'Chronotype moderation']","['insomnia severity, fatigue and psychological distress', 'ratings (Insomnia Severity Index, Chalder Fatigue Questionnaire, and Hospital Anxiety and Depression Scale', 'Chalder Fatigue Questionnaire', 'Hospital Anxiety and Depression Scale', 'psychological distress or fatigue', 'Insomnia Severity Index', 'Insomnia Severity Index, Chalder Fatigue Questionnaire, and Hospital Anxiety and Depression Scale', 'Insomnia Severity Index and Chalder Fatigue Questionnaire']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}]",1721.0,0.077906,"For individuals with self-reported evening chronotype, digital cognitive behavioural therapy for insomnia was superior to patient education for Insomnia Severity Index and Chalder Fatigue Questionnaire, but not on the Hospital Anxiety and Depression Scale (p = 0.139).","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Faaland', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Vedaa', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Langsrud', 'Affiliation': 'St Olavs University Hospital, Østmarka, Trondheim, Norway.'}, {'ForeName': 'Børge', 'Initials': 'B', 'LastName': 'Sivertsen', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Lydersen', 'Affiliation': 'Department of Mental Health, Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Cecilie L', 'Initials': 'CL', 'LastName': 'Vestergaard', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Kaia', 'Initials': 'K', 'LastName': 'Kjørstad', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vethe', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Ritterband', 'Affiliation': 'Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'Department of Psychology, University of California, Berkeley, California, USA.'}, {'ForeName': 'Tore C', 'Initials': 'TC', 'LastName': 'Stiles', 'Affiliation': 'Department of Psychology, Norwegian University of Science and Technology, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Scott', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Kallestad', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}]",Journal of sleep research,['10.1111/jsr.13572']
2750,35224797,Exercise in hypobaric hypoxia increases markers of intestinal injury and symptoms of gastrointestinal distress.,"NEW FINDING


What is the central question of this study? What is the effect of hypobaric hypoxia on markers of exercise-induced intestinal injury and symptoms of GI distress? What is the main finding and its importance? Exercise performed at 4300 m of simulated altitude increased I-FABP, CLDN-3, and LBP which together suggest that exercise-induced intestinal injury may be aggravated by concurrent hypoxic exposure. Increases in I-FABP, LBP, CLDN-3 were correlated to exercise-induced GI symptoms, providing some evidence of a link between intestinal barrier injury and symptoms of GI distress.
ABSTRACT


We sought to determine the effect of exercise in hypobaric hypoxia on markers of intestinal injury and gastrointestinal (GI) symptoms. Using a randomized and counterbalanced design, 9 males completed two experimental trials: one at local altitude of 1585 m (NORM) and one at 4300 m of simulated hypobaric hypoxia (HYP). Participants performed 60-minutes of cycling at a workload that elicited 65% of their NORM VO 2  max. GI symptoms were assessed before and every 15-minutes during exercise. Pre- and post-exercise blood samples were assessed for intestinal fatty acid binding protein (I-FABP), claudin-3 (CLDN-3), and lipopolysaccharide binding protein (LBP). All participants reported at least one GI symptom in HYP compared to just 1 participant in NORM. I-FABP significantly increased from pre- to post-exercise in HYP (708±191 to 1215±518 pg mL -1  ; p = 0.011, d = 1.10) but not NORM (759±224 to 828±288 pg mL -1  ; p>0.99, d = 0.27). CLDN-3 significantly increased from pre- to post-exercise in HYP (13.8±0.9 to 15.3±1.2 ng mL -1  ; p = 0.003, d = 1.19) but not NORM (13.7±1.8 to 14.2±1.6 ng mL -1  ; p = .435, d = 0.45). LBP significantly increased from pre- to post-exercise in HYP (10.8±1.2 to 13.9±2.8 μg mL -1  ; p = 0.006, d = 1.12) but not NORM (11.3±1.1 to 11.7±0.9 μg mL -1  ; p>0.99, d = 0.32). I-FABP (d = 0.85), CLDN-3 (d = 0.95), and LBP (d = 0.69) were all significantly higher post-exercise in HYP compared to NORM (p≤0.05). Overall GI discomfort was significantly correlated to ΔI-FABP (r = 0.71), ΔCLDN-3 (r = 0.70), and ΔLBP (r = 0.86). These data indicate that cycling exercise performed in hypobaric hypoxia can cause intestinal injury, which might cause some commonly reported GI symptoms. This article is protected by copyright. All rights reserved.",2022,"Increases in I-FABP, LBP, CLDN-3 were correlated to exercise-induced GI symptoms, providing some evidence of a link between intestinal barrier injury and symptoms of GI distress.
",['9 males completed two experimental trials: one at'],"['mL', 'hypobaric hypoxia', 'local altitude of 1585 m (NORM) and one at 4300 m of simulated hypobaric hypoxia (HYP']","['CLDN-3', 'Overall GI discomfort', 'ΔCLDN-3', 'GI symptoms', 'GI symptom', 'LBP', 'intestinal fatty acid binding protein (I-FABP), claudin-3 (CLDN-3), and lipopolysaccharide binding protein (LBP', 'intestinal injury and symptoms of gastrointestinal distress', 'intestinal injury and gastrointestinal (GI) symptoms']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4552489', 'cui_str': 'Hypobaric hypoxia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C1173118', 'cui_str': 'FABP2 protein, human'}, {'cui': 'C0065054', 'cui_str': 'lipopolysaccharide-binding protein'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0548823', 'cui_str': 'Distress gastrointestinal'}]",,0.0520807,"Increases in I-FABP, LBP, CLDN-3 were correlated to exercise-induced GI symptoms, providing some evidence of a link between intestinal barrier injury and symptoms of GI distress.
","[{'ForeName': 'Zachary J', 'Initials': 'ZJ', 'LastName': 'McKenna', 'Affiliation': 'Department of Health, Exercise and Sports Sciences, University of New Mexico Albuquerque, NM, USA.'}, {'ForeName': 'Zachary J', 'Initials': 'ZJ', 'LastName': 'Fennel', 'Affiliation': 'Department of Health, Exercise and Sports Sciences, University of New Mexico Albuquerque, NM, USA.'}, {'ForeName': 'Quint N', 'Initials': 'QN', 'LastName': 'Berkemeier', 'Affiliation': 'Department of Health, Exercise and Sports Sciences, University of New Mexico Albuquerque, NM, USA.'}, {'ForeName': 'Roberto C', 'Initials': 'RC', 'LastName': 'Nava', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Fabiano T', 'Initials': 'FT', 'LastName': 'Amorim', 'Affiliation': 'Department of Health, Exercise and Sports Sciences, University of New Mexico Albuquerque, NM, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Deyhle', 'Affiliation': 'Department of Health, Exercise and Sports Sciences, University of New Mexico Albuquerque, NM, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Mermier', 'Affiliation': 'Department of Health, Exercise and Sports Sciences, University of New Mexico Albuquerque, NM, USA.'}]",Experimental physiology,['10.1113/EP090266']
2751,35224781,A new in vitro method to predict in vivo photoprotection of skin hyperpigmentation induced by visible light.,"BACKGROUND


Ultraviolet radiation is the main cause of skin pigmentation, but more recently visible light has been shown to be an important contributor especially in melano-competent subjects. Photoprotection from visible light can improve several hyperpigmentation disorders. Recently a visible light photoprotection assessment method has been proposed based on in vivo pigmentation; the visible light photoprotection factor (VL-PF) is determined by assessment of the change in colorimetry parameter ITA over several days measured using a chromameter. Although in vivo methods remain the most representative of real life, in vitro methods are more suited to screening sunscreen formulations.
OBJECTIVE


The aim of this study was to evaluate the correlation between in vivo and in vitro methods in assessing protection against visible light induced pigmentation.
METHODS


We first analyzed the in vitro protective properties of the 10 commercially available sunscreens using transmission measurements in the visible spectrum. Then, we performed a monocentric, double-blind, randomized controlled study with intra-individual comparisons in 20 healthy subjects and measure the VL-PF in vivo of those sunscreens. The correlation between the VL-PF and the percentage of blocked light was evaluated using the coefficient of determination R 2  .
RESULTS


A strong significant correlation was demonstrated between in vivo visible light protection factor and in vitro transmittance measurements, with the highest correlation factor at 420 nm and in the spectrum covering from 400 to 469 nm.
CONCLUSION


Transmittance measurements were found to be a good predictive tool to evaluate sunscreen visible light photoprotection efficacy and could be used to select formulations for final in vivo testing.",2022,Transmittance measurements were found to be a good predictive tool to evaluate sunscreen visible light photoprotection efficacy and could be used to select formulations for final in vivo testing.,['20 healthy subjects and measure the VL-PF in vivo of those sunscreens'],[],[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242377', 'cui_str': 'Visible light'}, {'cui': 'C0038818', 'cui_str': 'Sunscreen agent'}]",[],[],20.0,0.0185768,Transmittance measurements were found to be a good predictive tool to evaluate sunscreen visible light photoprotection efficacy and could be used to select formulations for final in vivo testing.,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Duteil', 'Affiliation': ""Center of Clinical Pharmacology Applied to Dermatology (CPCAD), L'Archet 2 Hospital, Nice, France.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cadars', 'Affiliation': 'NAOS, Research and Development Department, Lyon, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Queille-Roussel', 'Affiliation': ""Center of Clinical Pharmacology Applied to Dermatology (CPCAD), L'Archet 2 Hospital, Nice, France.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Giraud', 'Affiliation': 'NAOS Les Laboratoires, Research and Development Department, Aix-en-Provence, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Drulhon', 'Affiliation': 'NAOS Les Laboratoires, Research and Development Department, Aix-en-Provence, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Graizeau', 'Affiliation': 'NAOS ILS, Research and Development Department, Aix-en-Provence, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guyoux', 'Affiliation': 'NAOS Les Laboratoires, Research and Development Department, Aix-en-Provence, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Passeron', 'Affiliation': ""Department of Dermatology, Centre Hospitalier Universitaire de Nice, University Côte d'Azur, Nice, France.""}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.18034']
2752,35224778,Maxillary sinus floor augmentation comparing bovine versus porcine bone xenografts mixed with autogenous bone graft. A split-mouth randomized controlled trial.,"AIM


To compare the effectiveness of two xenografts for maxillary sinus floor augmentation in terms of clinical, radiographical, histologic, and molecular outcomes.
MATERIALS AND METHODS


A split-mouth randomized clinical trial was conducted at the University of Granada. Ten consecutive patients in need of bilateral two-staged maxillary sinus floor augmentation were included. Each patient received both biomaterials (porcine bone mineral and anorganic bovine bone), which were randomly assigned for bilateral sinus augmentation. The maxillary autogenous bone scraped from the sinus access window was mixed with each xenograft at a 20:80 ratio. After a healing period of 6 months, bone biopsies were collected with a trephine during the implant placement in the regenerated area. Histologic, histomorphometrical, immunohistochemical, and molecular outcomes were analyzed. Clinical and radiographical data throughout the treatment phases were also evaluated.
RESULTS


The resulting anatomic features were similar between both groups. After six months of graft consolidation, the graft resorption rates were similar between both biomaterials. The histologic, histomorphometrical, and immunohistochemical results showed no statistical differences between groups.
CONCLUSION


Anorganic bovine bone and porcine bone mineral combined with maxillary autogenous cortical bone show similar biologic and radiologic features in terms of biomaterial resorption, osteoconduction, and osteogenesis when used for maxillary sinus floor augmentation.",2022,"The histological, histomorphometrical and immunohistochemical results showed no statistical differences between groups.
",['Ten consecutive patients in need of bilateral two staged maxillary sinus floor augmentation were included'],"['biomaterials (porcine bone mineral and anorganic bovine bone', 'Anorganic bovine bone and porcine bone mineral combined with maxillary autogenous cortical bone', 'bovine vs. porcine bone xenografts mixed with autogenous bone graft']","['Histological, histomorphometrical, immunohistochemical and molecular outcomes', 'graft resorption rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3178819', 'cui_str': 'Sinus Augmentation Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0005479', 'cui_str': 'Biomaterials'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0440800', 'cui_str': 'Autogenous bone graft'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]",10.0,0.0932531,"The histological, histomorphometrical and immunohistochemical results showed no statistical differences between groups.
","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Galindo-Moreno', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Abril-García', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Ana Belen', 'Initials': 'AB', 'LastName': 'Carrillo-Galvez', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Zurita', 'Affiliation': 'Department of Genetics, School of Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Natividad', 'Initials': 'N', 'LastName': 'Martín-Morales', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': ""O'Valle"", 'Affiliation': 'Department of Pathology, School of Medicine, University of Granada, Granada, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Padial-Molina', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}]",Clinical oral implants research,['10.1111/clr.13912']
2753,35227399,"The Circle of Security Parenting Program (COS-P): A Randomized Controlled Trial of a Low Intensity, Individualized Attachment-Based Program With at-Risk Caregivers.","The Circle of Security-Parenting Intervention (COS-P; Cooper et al., 2009) is a psychoeducational program for caregivers of young children that has been widely disseminated. The program is founded in attachment theory and relies on computer-delivered content and parent reflection and discussion to teach concepts of safety and security to promote better caregiver-child relationships and child wellbeing. The present study is a randomized controlled trial of COS-P, individually delivered to 85 Australian caregivers (51 COS-P, 34 waitlist control) who reported parenting distress and child disruptive behaviors. Caregivers completed a baseline assessment and repeated the assessment after completion of COS-P or 8 weeks on the waitlist. Caregivers completed surveys to report child symptoms, and parenting stress, anxious and avoidant attachment, reflective functioning, parenting practices, and depressive symptoms. No differences in COS-P vs. waitlist participants were found at baseline. Analyses of complete data (35 COS-P, 25-26 waitlist) revealed a greater decline in caregivers' attachment anxiety and negative parenting relative to waitlist, but only attachment anxiety in intent-to-treat analyses. Other improvements were found, but these extended to both the COS-P and waitlist conditions and did not differ between conditions. Overall, effects of COS-P were small and rarely significant, suggesting the need to consider alternative programs that have evidence of effectiveness when providing services to at-risk families.",2022,"Other improvements were found, but these extended to both the COS-P and waitlist conditions and did not differ between conditions.","['85 Australian caregivers (51 COS-P, 34 waitlist control) who reported parenting distress and child disruptive behaviors']","['Low Intensity, Individualized Attachment-Based Program With at-Risk Caregivers', 'Security Parenting Program (COS-P']","['report child symptoms, and parenting stress, anxious and avoidant attachment, reflective functioning, parenting practices, and depressive symptoms', 'attachment anxiety', ""caregivers' attachment anxiety and negative parenting relative to waitlist""]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]",,0.100842,"Other improvements were found, but these extended to both the COS-P and waitlist conditions and did not differ between conditions.","[{'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Zimmer-Gembeck', 'Affiliation': 'Griffith University, School of Applied Psychology and Menzies Health Institute of Queensland. Electronic address: m.zimmer-gembeck@griffith.edu.au.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Rudolph', 'Affiliation': 'Griffith University, School of Applied Psychology.'}, {'ForeName': 'Elia-Jade', 'Initials': 'EJ', 'LastName': 'Edwards', 'Affiliation': 'Griffith University, School of Applied Psychology.'}, {'ForeName': 'Kellie', 'Initials': 'K', 'LastName': 'Swan', 'Affiliation': 'Griffith University, School of Applied Psychology and Menzies Health Institute of Queensland.'}, {'ForeName': 'Shawna M', 'Initials': 'SM', 'LastName': 'Campbell', 'Affiliation': 'Griffith University, School of Applied Psychology and Menzies Health Institute of Queensland.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Hawes', 'Affiliation': 'Griffith University, School of Applied Psychology.'}, {'ForeName': 'Haley J', 'Initials': 'HJ', 'LastName': 'Webb', 'Affiliation': 'Griffith University, School of Applied Psychology.'}]",Behavior therapy,['10.1016/j.beth.2021.07.003']
2754,35227370,Effectiveness of the Enriched Stuttering Intervention Program Used in Stuttering Children.,"Objectives:  In this study, we examined the effectiveness of the Enriched Stuttering Intervention Program (ESIP), developed by the researchers, on children with stuttering difficulties. More specifically, we examined the frequency of stuttering, duration of stuttering, behaviors accompanying stuttering, and whether there was a significant difference in the naturalness of speech.  Methods:  We used a quasi-experimental design. The study group study consisted of 5 boys admitted to a Special Education and Rehabilitation Centre during 2019-2020 and diagnosed by a pediatric psychiatrist with stuttering. The information forms prepared by the researchers were used to be completed by the family, the teacher, and the child to collect personal information about the children. We used the Stuttering Severity Instrument (SSI-4) to collect our research data.  Results:  When we compared pre-test and post-test data, we found a statistically significant difference in the severity of stuttering in the 5 children.  Conclusion:  The Enriched Stuttering Intervention Program improved stuttering in this group of children.",2022,The Enriched Stuttering Intervention Program improved stuttering in this group of children.,"['children with stuttering difficulties', 'Stuttering Children', '5 boys admitted to a Special Education and Rehabilitation Centre during 2019-2020 and diagnosed by a pediatric psychiatrist with stuttering']",['Enriched Stuttering Intervention Program (ESIP'],"['frequency of stuttering, duration of stuttering, behaviors accompanying stuttering', 'naturalness of speech']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038506', 'cui_str': 'Stuttering'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0013649', 'cui_str': 'Special Education'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}]","[{'cui': 'C0475512', 'cui_str': 'Stuttering intervention program'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038506', 'cui_str': 'Stuttering'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",5.0,0.0123205,The Enriched Stuttering Intervention Program improved stuttering in this group of children.,"[{'ForeName': 'Iclal', 'Initials': 'I', 'LastName': 'Ertas', 'Affiliation': 'Dr. Iclal Ertas, Special Education, Near East University, Mersin, Turkey;, Email: iclalertas06@gmail.com.'}, {'ForeName': 'Gönül', 'Initials': 'G', 'LastName': 'Akçamete', 'Affiliation': 'Gönül Akçamete, Special Education, Near East University, Mersin, Turkey.'}, {'ForeName': 'Mukaddes Sakallı', 'Initials': 'MS', 'LastName': 'Demirok', 'Affiliation': 'Mukaddes Sakallı Demirok, Special Education, Near East University, Mersin, Turkey.'}]",American journal of health behavior,['10.5993/AJHB.46.1.6']
2755,35227369,Exploring Associations of Household Chaos and Child Health Behaviors in Rural Families.,"Objectives:  Regular physical activity (PA) and limited sedentary behavior (SB) and screen-time are essential for children's health, and rural children are more likely to have overweight and obesity. Household chaos (HHchaos), defined as disorganization characterized by noise and crowding, is associated with negative behavioral outcomes in children. In this study, we examined associations between HHchaos and PA, SB, and screen-time among rural children.  Methods:  Parent/child dyads (N=105) were enrolled in NU-HOME, a family-based, obesity prevention randomized-controlled trial. We used hierarchical regression analyses of baseline data to examine unadjusted and adjusted (child age, sex, BMI z-scores and economic assistance) associations between HHchaos and outcomes.  Results:  Children were 8.96 ± 1.06 years old; 58% were female; and 53% were categorized as normal weight. Total daily PA, SB, and weekday screen-time were 259.1 ± 58.22 minutes, 499.9 ± 77.46 minutes, and 1.79 ± 1.48 hours, respectively. Unadjusted HHchaos scores (mean = 5.04 ± 3.6; range = 0-15 with higher score indicating more chaos) were not associated with child PA or SB. HHchaos was positively associated with child screen-time in all models (p<.05), except the fully adjusted model for weekday screen-time.  Conclusions:  Our findings suggest that decreasing household chaos may be useful in reducing child screen-time. Our findings align with current literature in viewing household chaos as a risk factor for children's health.",2022,"HHchaos was positively associated with child screen-time in all models (p<.05), except the fully adjusted model for weekday screen-time.  ","['N=105) were enrolled in NU-HOME, a family-based, obesity prevention randomized-controlled trial', 'were 8.96 ± 1.06 years old; 58% were female; and 53% were categorized as normal weight', ""children's health, and rural children"", 'children', 'child dyads ', 'rural children', 'Rural Families']",['Regular physical activity (PA) and limited sedentary behavior (SB) and screen-time'],"['Unadjusted HHchaos scores', 'HHchaos and PA, SB, and screen-time', 'Total daily PA, SB, and weekday screen-time', 'Household Chaos and Child Health Behaviors', 'child screen-time']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4708781', 'cui_str': '1.06'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1194380', 'cui_str': 'Chaos'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",105.0,0.107412,"HHchaos was positively associated with child screen-time in all models (p<.05), except the fully adjusted model for weekday screen-time.  ","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Grace', 'Affiliation': 'University of Minnesota, Twin Cities, United States.'}, {'ForeName': 'Daheia J', 'Initials': 'DJ', 'LastName': 'Barr-Anderson', 'Affiliation': 'University of Minnesota, Twin Cities, United States.'}, {'ForeName': 'Jayne A', 'Initials': 'JA', 'LastName': 'Fulkerson', 'Affiliation': 'University of Minnesota, Twin Cities, United States; grace130@umn. edu.'}]",American journal of health behavior,['10.5993/AJHB.46.1.5']
2756,35227810,Early Results of a Randomized Controlled Trial of Partial Versus Total Knee Arthroplasty.,"INTRODUCTION


Debate still exists regarding the benefits of unicompartmental (UKA) versus total knee arthroplasty (TKA) for the treatment of medial compartment osteoarthritis. The purpose of this randomized trial is to compare the early outcomes of UKA versus TKA.
METHODS


107 candidates for UKA were randomized at two centers; 57 received a UKA and 50, a TKA. 6-week and 6-month outcome measures including KOOS Jr., Knee Society Score, Forgotten Joint Score, and VR-12 global health scores were obtained. No demographic or baseline patient reported outcome (PRO) differences were present suggesting successful randomization (p>0.05).
RESULTS


UKA demonstrated shorter operative times (UKA=65 min, TKA=74 min; p< 0.001) and length of stay (UKA=0.7 nights, TKA=1.2 nights; p< 0.01). At 6 weeks there were no differences in KOOS Jr. (p=0.755), KSS (p=0.754), or FJS (p=0.664) or PRO change from preoperative scores (p=0.468). There were three surgical complications within 90 days in each group. Duration of opioid consumption (UKA = 33.8 days, TKA = 28.5 days; p=0.290) and return to work (UKA = 57.1 days, TKA = 47.3 days; p=0.346) did not differ between groups.
CONCLUSION


Data suggests no clinically significant differences between UKA and TKA in the early postoperative period in regards to PROMs, duration of opioid use, or return to work. Patients undergoing UKA can anticipate a shorter length of stay and greater early range of motion. All cause short-term complications may be more prevalent with TKA.",2022,"RESULTS


UKA demonstrated shorter operative times (UKA=65 min, TKA=74 min; p< 0.001) and length of stay (UKA=0.7 nights, TKA=1.2 nights; p< 0.01).","['107 candidates for UKA were randomized at two centers', 'medial compartment osteoarthritis']","['Partial Versus Total Knee Arthroplasty', 'unicompartmental (UKA) versus total knee arthroplasty (TKA', 'UKA versus TKA', 'UKA and TKA']","['Duration of opioid consumption', 'surgical complications', 'KOOS Jr., Knee Society Score, Forgotten Joint Score, and VR-12 global health scores', 'shorter operative times', 'shorter length of stay and greater early range of motion', 'length of stay']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4759288', 'cui_str': 'Forgotten Joint Score'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",107.0,0.22758,"RESULTS


UKA demonstrated shorter operative times (UKA=65 min, TKA=74 min; p< 0.001) and length of stay (UKA=0.7 nights, TKA=1.2 nights; p< 0.01).","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Sershon', 'Affiliation': ''}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Fricka', 'Affiliation': ''}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Hamilton', 'Affiliation': ''}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Nam', 'Affiliation': ''}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Parks', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'DeBenedetti', 'Affiliation': ''}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Della Valle', 'Affiliation': ''}]",The Journal of arthroplasty,['10.1016/j.arth.2022.02.076']
2757,35227982,New music system reveals spectral contribution to statistical learning.,"Knowledge of speech and music depends upon the ability to perceive relationships between sounds in order to form a stable mental representation of statistical structure. Although evidence exists for the learning of musical scale structure from the statistical properties of sound events, little research has been able to observe how specific acoustic features contribute to statistical learning independent of the effects of long-term exposure. Here, using a new musical system, we show that spectral content is an important cue for acquiring musical scale structure. In two experiments, participants completed probe-tone ratings before and after a half-hour period of exposure to melodies in a novel musical scale with a predefined statistical structure. In Experiment 1, participants were randomly assigned to either a no-exposure control group, or to exposure groups who heard pure tone or complex tone sequences. In Experiment 2, participants were randomly assigned to exposure groups who heard complex tones constructed with odd harmonics or even harmonics. Learning outcome was assessed by correlating pre/post-exposure ratings and the statistical structure of tones within the exposure period. Spectral information significantly affected sensitivity to statistical structure: participants were able to learn after exposure to all tested timbres, but did best at learning with timbres with odd harmonics, which were congruent with scale structure. Results show that spectral amplitude distribution is a useful cue for statistical learning, and suggest that musical scale structure might be acquired through exposure to spectral distribution in sounds.",2022,"Spectral information significantly affected sensitivity to statistical structure: participants were able to learn after exposure to all tested timbres, but did best at learning with timbres with odd harmonics, which were congruent with scale structure.",[],"['heard complex tones constructed with odd harmonics or even harmonics', 'no-exposure control group, or to exposure groups who heard pure tone or complex tone sequences']",['Learning outcome'],[],"[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0288855,"Spectral information significantly affected sensitivity to statistical structure: participants were able to learn after exposure to all tested timbres, but did best at learning with timbres with odd harmonics, which were congruent with scale structure.","[{'ForeName': 'Psyche', 'Initials': 'P', 'LastName': 'Loui', 'Affiliation': 'Northeastern University, USA. Electronic address: p.loui@northeastern.edu.'}]",Cognition,['10.1016/j.cognition.2022.105071']
2758,35227973,Role of multicomponent non-pharmacological nursing interventions on delirium prevention: A randomized controlled study.,"Multicomponent-Non-PharmacologicalNursingInterventions (Multi-Non-PharmaNIs) are evidence-based recommendations for the prevention of delirium. Purpose of this randomized controlled trial was to compare the effects of Multi-Non-PharmaNIs on delirium. The Multi-Non-PharmaNIs included orientation strategies (playing audio recordings of a non-family/family member), reading a daily newspaper, andwearing an eye patch at night. The absence/presence of delirium was assessed two times a day for three consecutive days. The patients in Group1 were made to listen to the orientation messages recorded in a non-family member's voice (10 min), was read newspaper, and wore an eye patch at night. Group2 received the same interventions as Group1, only the orientation messages were recorded in a family member's voice. The control group received standard nursing-care. There was a significant difference between 3 groups. When Group1 and Group2 were compared with the control group, it was found that there was a significant difference between Group2 and control group (p<0.05). Multi-Non-PharmaNIs were found to reduce delirium in critically ill patients.",2022,"Group2 received the same interventions as Group1, only the orientation messages were recorded in a family member's voice.",['critically ill patients'],"['Multi-Non-PharmaNIs', 'Multicomponent-Non-PharmacologicalNursingInterventions', 'multicomponent non-pharmacological nursing interventions', 'standard nursing-care']","['delirium', 'delirium prevention']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028678', 'cui_str': 'nursing'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",,0.0535663,"Group2 received the same interventions as Group1, only the orientation messages were recorded in a family member's voice.","[{'ForeName': 'Elçin Sebahat', 'Initials': 'ES', 'LastName': 'Kasapoğlu', 'Affiliation': 'Department of Elderly Care, Vocational College of Health Services, Bartın University, Agdaci Campus, Bartın 74100, Turkey. Electronic address: ekasapoglu@bartin.edu.tr.'}, {'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Enç', 'Affiliation': 'Department of Internal Medicine Nursing, Florence Nightingale Faculty of Nursing, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2022.02.015']
2759,35227959,Early initiation of norepinephrine in patients with septic shock: A propensity score-based analysis.,"BACKGROUND


The use of vasopressors is vital in septic shock. However, the optimal timing of treatment remains unclear. Therefore, we aimed to explore the impact of early norepinephrine initiation on the survival of patients with septic shock.
METHODS


We selected 4253 patients from the Medical Information Mart for Intensive Care IV database between 2008 and 2019. The primary outcome was 28-day mortality. Propensity score matching (PSM) was applied to minimize between-group imbalances, and a restricted mean survival time was used to quantify the beneficial impact of early norepinephrine treatment on survival. Sensitivity analyses were conducted to test the robustness of the study results in multiple cohorts.
RESULTS


In the PSM cohort, 2862 patients were equally assigned to early (receiving norepinephrine within the first 3 h) and delayed (> 3 h) norepinephrine initiation groups. Patients in the early norepinephrine initiation group received significantly less fluid therapy (0 vs. 79 mL/kg), had lower 28-day mortality (30.0% vs. 37.8%), longer survival days (21.89 vs. 20.37 days), shorter duration of intensive care unit (4.9 vs. 7.2 days) and hospital stays (12.4 vs. 13.6 days), shorter duration of supportive norepinephrine and invasive mechanical ventilation, lower incidence of organ failure progression (64.4% vs. 79.2%) within 24 h after shock onset, and higher mean arterial pressure within 6 and 24 h after shock onset than patients in the delayed norepinephrine initiation group (p < 0.05).
CONCLUSIONS


Norepinephrine initiation within the first 3 h, regardless of preload dependency, was associated with longer survival time and shorter duration of supportive norepinephrine and invasive mechanical ventilation and may delay or partially reverse rapid onset organ failure.",2022,"Patients in the early norepinephrine initiation group received significantly less fluid therapy (0 vs. 79 mL/kg), had lower 28-day mortality (30.0% vs. 37.8%), longer survival days (21.89 vs. 20.37 days), shorter duration of intensive care unit (4.9 vs. 7.2 days) and hospital stays (12.4 vs. 13.6 days), shorter duration of supportive norepinephrine and invasive mechanical ventilation, lower incidence of organ failure progression (64.4% vs. 79.2%) within 24 h after shock onset, and higher mean arterial pressure within 6 and 24 h after shock onset than patients in the delayed norepinephrine initiation group (p < 0.05).
","['patients with septic shock', '4253 patients from the Medical Information Mart for Intensive Care IV database between 2008 and 2019', '2862 patients were equally assigned to early (receiving']","['norepinephrine initiation', 'norepinephrine']","['longer survival days', 'longer survival time', 'shorter duration of supportive norepinephrine and invasive mechanical ventilation, lower incidence of organ failure progression', 'mean arterial pressure', 'shorter duration of intensive care unit', '28-day mortality', 'fluid therapy', 'survival', 'hospital stays']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",4253.0,0.131533,"Patients in the early norepinephrine initiation group received significantly less fluid therapy (0 vs. 79 mL/kg), had lower 28-day mortality (30.0% vs. 37.8%), longer survival days (21.89 vs. 20.37 days), shorter duration of intensive care unit (4.9 vs. 7.2 days) and hospital stays (12.4 vs. 13.6 days), shorter duration of supportive norepinephrine and invasive mechanical ventilation, lower incidence of organ failure progression (64.4% vs. 79.2%) within 24 h after shock onset, and higher mean arterial pressure within 6 and 24 h after shock onset than patients in the delayed norepinephrine initiation group (p < 0.05).
","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Intensive Care Unit, The First Affiliated Hospital of Guangxi Medical University, 6S Shuangyong Road, Nanning 530021, Guangxi, China; Department of Intensive Care Unit, The Affiliated Hospital of Guilin Medical University, 15S Lequn Road, Guilin 541001, Guangxi, China. Electronic address: xxy20180430@126.com.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhong', 'Affiliation': 'Department of Intensive Care Unit, The Affiliated Hospital of Guilin Medical University, 15S Lequn Road, Guilin 541001, Guangxi, China. Electronic address: zhongrong870@126.com.'}, {'ForeName': 'Shanyang', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'Department of Intensive Care Unit, The Affiliated Hospital of Guilin Medical University, 15S Lequn Road, Guilin 541001, Guangxi, China. Electronic address: 357852014@qq.com.'}, {'ForeName': 'Yiqian', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Intensive Care Unit, Zhuzhou Central Hospital, 116S South Changjiang Road, Zhuzhou 412007, Hunan, China. Electronic address: zengyiqian@stu.gxmu.edu.cn.'}, {'ForeName': 'Zhanhong', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'Department of Intensive Care Unit, The First Affiliated Hospital of Guangxi Medical University, 6S Shuangyong Road, Nanning 530021, Guangxi, China. Electronic address: tangzhanhong139@sina.com.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2022.01.063']
2760,35227940,"Immediate-release/extended-release amantadine (OS320) to treat Parkinson's disease with levodopa-induced dyskinesia: Analysis of the randomized, controlled ALLAY-LID studies.","BACKGROUND


Immediate-release (IR) amantadine has been used for treatment of levodopa induced dyskinesia (LID). The immediate-release/extended-release (IR/ER) amantadine formulation OS320 (OSMOLEX ER®) contains an IR outer layer and ER core for once-daily dosing.
OBJECTIVE


Report individual and pooled results for the similarly designed double-blind, placebo-controlled ALLAY-LID I and II trials, assessing IR/ER-amantadine for LID.
METHODS


PD patients with LID were randomized to IR/ER-amantadine 193 mg, 258 mg, or placebo. Primary endpoint was Unified Dyskinesia Rating Scale (UDysRS) score change from baseline to Day 98. Secondary outcome was ON time without troublesome dyskinesia based on diaries. Exploratory outcomes were other diary states (including OFF), MDS-UPDRS Parts II + III and Fatigue Severity Scale.
RESULTS


Overall, 222 individuals enrolled (N = 87 ALLAY-LID I, N = 135 ALLAY-LID II); both trials terminated early for sponsor's decision. While ALLAY-LID I did not meet its primary endpoint, a significant reduction in UDysRS scores versus placebo was observed in ALLAY-LID II for both 193 mg and 258 mg doses. In the pooled analysis, placebo-adjusted UDysRS score differences were -5.5 [-9.8, -1.2], p = 0.012 and -5.2 [-9.5, -0.9], p = 0.017, respectively. IR/ER-amantadine 258 mg significantly increased time spent ON without troublesome dyskinesia in ALLAY-LID II and pooled analysis. Reductions in ON time with dyskinesia supported the primary outcome. There was no effect on OFF time or other outcomes. Overall, 13.3% (193 mg), 18.7% (258 mg) and 11.1% (placebo) discontinued for adverse events, most commonly hallucinations (4.0%, 10.7%, and 1.4%, respectively).
CONCLUSIONS


IR/ER-amantadine significantly reduced LID in ALLAY-LID II but not in ALLAY-LID I; post-hoc pooled data also indicated a positive treatment effect on LID.",2022,IR/ER-amantadine 258 mg significantly increased time spent ON without troublesome dyskinesia in ALLAY-LID II and pooled analysis.,"['222 individuals enrolled (N\xa0=\xa087', 'PD patients with LID', ""Parkinson's disease with levodopa-induced dyskinesia""]","['Immediate-release/extended-release amantadine (OS320', 'placebo', 'IR/ER-amantadine 193\xa0mg, 258\xa0mg, or placebo', 'IR/ER-amantadine', 'amantadine']","['UDysRS scores', 'Unified Dyskinesia Rating Scale (UDysRS) score change', 'ON time without troublesome dyskinesia based on diaries', 'OFF time', 'LID', 'time spent ON without troublesome dyskinesia', 'diary states (including OFF), MDS-UPDRS Parts II\xa0+\xa0III and Fatigue Severity Scale', 'LID in ALLAY-LID']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0002403', 'cui_str': 'Amantadine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4691802', 'cui_str': 'Amantadine 193 MG'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",222.0,0.30264,IR/ER-amantadine 258 mg significantly increased time spent ON without troublesome dyskinesia in ALLAY-LID II and pooled analysis.,"[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Rascol', 'Affiliation': 'University of Toulouse 3, University Hospital of Toulouse, INSERM, Clinical Investigation Center CIC1436, Parkinson Expert Center, Department of Neurology and Department of Clinical Pharmacology, NS- Park/FCRIN Network et Centre of Excellence for Neurodegenerative Disorders (COEN) of Toulouse, Toulouse, France.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Tönges', 'Affiliation': 'Ruhr-University Bochum, St. Josef-Hospital, Department of Neurology, Bochum, Germany; Ruhr-University Bochum, Center for Protein Diagnostics (ProDi), Experimental Neurology, Bochum, Germany. Electronic address: lars.toenges@ruhr-uni-bochum.de.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'deVries', 'Affiliation': 'Osmotica Pharmaceutical US LLC, Bridgewater, NJ, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jaros', 'Affiliation': 'Osmotica Pharmaceutical US LLC, Bridgewater, NJ, USA; Summit Analytical, Denver, CO, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Quartel', 'Affiliation': 'Adamas Pharmaceuticals, Inc., 1900 E. Powell St., Suite 1000, Emeryville, CA, 94608, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jacobs', 'Affiliation': 'Osmotica Pharmaceutical US LLC, Bridgewater, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2022.01.022']
2761,35225716,Use of a High-Fidelity Training Simulator for Minimally Invasive Lumbar Decompression Increases Working Knowledge and Technical Skills Among Orthopedic and Neurosurgical Trainees.,"STUDY DESIGN


Prospective comparative study.
OBJECTIVE


To quantify the educational benefit to surgical trainees of using a high-fidelity simulator to perform minimally invasive (MIS) unilateral laminotomy for bilateral decompression (ULBD) for lumbar stenosis.
METHODS


Twelve orthopedic and neurologic surgery residents performed three MIS ULBD procedures over 2 weeks on a simulator guided by established AO Spine metrics. Video recording of each surgery was rated by three blinded, independent experts using a global rating scale. The learning curve was evaluated with attention to technical skills, skipped steps, occurrence of errors, and timing. A knowledge gap analysis evaluating participants' current vs desired ability was performed after each trial.
RESULTS


From trial 1 to 3, there was a decrease in average procedural time by 31.7 minutes. The cumulative number of skipped steps and surgical errors decreased from 25 to 6 and 24 to 6, respectively. Overall surgical proficiency improved as indicated by video rating of efficiency and smoothness of surgical maneuvers, most notably with knowledge and handling of instruments. The greatest changes were noted in junior rather than senior residents. Average knowledge gap analysis significantly decreased by 30% from the first to last trial (P = .001), signifying trainees performed closer to their desired technical goal.
CONCLUSION


Procedural metrics for minimally invasive ULBD in combination with a realistic surgical simulator can be used to improve the skills and confidence of trainees. Surgical simulation may offer an important educational complement to traditional methods of skill acquisition and should be explored further with other MIS techniques.",2022,"Average knowledge gap analysis significantly decreased by 30% from the first to last trial (P = .001), signifying trainees performed closer to their desired technical goal.
",['Twelve orthopedic and neurologic surgery residents performed three'],"['MIS ULBD procedures over 2\xa0weeks on a simulator guided by established AO Spine metrics', 'high-fidelity simulator to perform minimally invasive (MIS) unilateral laminotomy for bilateral decompression (ULBD', 'High-Fidelity Training Simulator']","['video rating of efficiency and smoothness of surgical maneuvers', 'Technical Skills', 'cumulative number of skipped steps and surgical errors', 'Average knowledge gap analysis', 'average procedural time', 'Overall surgical proficiency']","[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0392866', 'cui_str': 'Laminotomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0038924', 'cui_str': 'Surgical Error'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",12.0,0.0324656,"Average knowledge gap analysis significantly decreased by 30% from the first to last trial (P = .001), signifying trainees performed closer to their desired technical goal.
","[{'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Melcher', 'Affiliation': 'Department of Orthopedic Surgery, Physical Medicine and Rehabilitation, University Hospital Munich, Munich, Germany.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Hussain', 'Affiliation': 'Department of Neurological Surgery Weill Cornell Brain and Spine Center, 189446New York Presbyterian Hospital, New York, NY, USA.'}, {'ForeName': 'Sertac', 'Initials': 'S', 'LastName': 'Kirnaz', 'Affiliation': 'Department of Neurological Surgery Weill Cornell Brain and Spine Center, 189446New York Presbyterian Hospital, New York, NY, USA.'}, {'ForeName': 'Jacob L', 'Initials': 'JL', 'LastName': 'Goldberg', 'Affiliation': 'Department of Neurological Surgery Weill Cornell Brain and Spine Center, 189446New York Presbyterian Hospital, New York, NY, USA.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Sommer', 'Affiliation': 'Department of Neurological Surgery Weill Cornell Brain and Spine Center, 189446New York Presbyterian Hospital, New York, NY, USA.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Navarro-Ramirez', 'Affiliation': 'Department of Neurological Surgery Weill Cornell Brain and Spine Center, 189446New York Presbyterian Hospital, New York, NY, USA.'}, {'ForeName': 'Branden', 'Initials': 'B', 'LastName': 'Medary', 'Affiliation': 'Department of Neurological Surgery Weill Cornell Brain and Spine Center, 189446New York Presbyterian Hospital, New York, NY, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Härtl', 'Affiliation': 'Department of Neurological Surgery Weill Cornell Brain and Spine Center, 189446New York Presbyterian Hospital, New York, NY, USA.'}]",Global spine journal,['10.1177/21925682221076044']
2762,35225551,A glued technique of external dacryocystorhinostomy.,"Purpose


Fibrin glue was used for anastomosis of lacrimal sac and nasal mucosal flaps and was compared with the conventional suture technique in external dacryocystorhinostomy.
Methods


A prospective interventional randomized control study in which 50 consecutive patients of primary acquired nasolacrimal duct obstruction (PANDO) were equally allocated into two groups. The case group underwent glued technique of external dacryocystorhinostomy (Ext DCR) in which fibrin glue was used for the apposition of the anterior lacrimal sac and nasal mucosal flaps. In the control group, conventional technique of Ext DCR was used to suture the flaps. Functional success was assessed by improvement in epiphora and fluorescein dye disappearance test (FDDT), whereas anatomical success was assessed by lacrimal irrigation and endoscopic view of the osteotomy site.
Results


The anatomical success in both the groups was 92%, whereas the functional success was 92% in the case group and 88% in the control group. The difference in the success rates between the two groups was statistically non-significant.
Conclusion


Glued technique of Ext DCR is a simple and easy alternative to suturing of the flaps. Though the final outcome was comparable in both the groups, glue can be especially useful in uncooperative cases, in cases of excessive bleeding, or in situations where the flaps are very thin or have become friable.",2022,"The difference in the success rates between the two groups was statistically non-significant.
Conclusion


Glued technique of Ext DCR is a simple and easy alternative to suturing of the flaps.",['50 consecutive patients of primary acquired nasolacrimal duct obstruction (PANDO'],"['conventional technique of Ext DCR', 'glued technique of external dacryocystorhinostomy (Ext DCR', 'external dacryocystorhinostomy', 'Fibrin glue']","['success rates', 'Functional success', 'epiphora and fluorescein dye disappearance test (FDDT', 'functional success', 'anatomical success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282418', 'cui_str': 'Primary acquired nasolacrimal duct obstruction'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0152227', 'cui_str': 'Epiphora'}, {'cui': 'C1633730', 'cui_str': 'Fluorescein dye disappearance test'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}]",50.0,0.0111378,"The difference in the success rates between the two groups was statistically non-significant.
Conclusion


Glued technique of Ext DCR is a simple and easy alternative to suturing of the flaps.","[{'ForeName': 'Syed Ali Raza', 'Initials': 'SAR', 'LastName': 'Rizvi', 'Affiliation': 'Ophthalmology, Oculoplasty and Ocular Oncology Services, Al Nahdha Hospital, Ministry of Health, Muscat, Sultanate of Oman; Institute of Ophthalmology, Jawaharlal Nehru Medical, College, AMU, Aligarh, UP, India.'}, {'ForeName': 'Mehnaz', 'Initials': 'M', 'LastName': 'Sabah', 'Affiliation': 'Susrut Eye Foundation and Research Center, Kolkata, West Bengal; Institute of Ophthalmology, Jawaharlal Nehru Medical, College, AMU, Aligarh, UP, India.'}, {'ForeName': 'Faizan', 'Initials': 'F', 'LastName': 'Mehmood', 'Affiliation': 'Bharti Eye Hospital, New Delhi; Institute of Ophthalmology, Jawaharlal Nehru Medical, College, AMU, Aligarh, UP, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Maheshwari', 'Affiliation': 'Institute of Ophthalmology, Jawaharlal Nehru Medical College, AMU, Aligarh, UP, India.'}, {'ForeName': 'Md Shahid', 'Initials': 'MS', 'LastName': 'Alam', 'Affiliation': 'Institute of Ophthalmology, Jawaharlal Nehru Medical, College, AMU, Aligarh, UP; Orbit Oculoplasty, Reconstructive and Aesthetic Service, Aditya Birla Sankara Nethralaya, Kolkata, West Bengal, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1950_21']
2763,35225548,Evaluation of reinforced plication as an alternative to resection in exotropia.,"Purpose


To evaluate the surgical efficacy of reinforced plication of the medial rectus muscle to resection as an effective muscle strengthening procedure in exotropia.
Methods


This is a prospective randomized trial in patients with exotropia who underwent complete orthoptic evaluation followed by random assignment into two groups by using a computer-drawn random number table. Group 1 patients underwent standard resection with recession procedure, and group 2 patients underwent reinforced plication with recession procedure. Follow-up was performed at day 1, 1 week, 1 month, 3 months, and 6 months to assess the surgical efficacy.
Results


A total of 80 patients were included in the study of which 39 were in group 1 and 41 in group 2. The mean age in group 1 was 23.48 ± 11.94 years and 23.29 ± 10.02 years in group 2. The mean preoperative deviation in group 1 for distance was 50.13 ± 11.95 PD and 50.12 ± 9.79 PD in group 2 (P = 0.499). In group 1 with a mean surgical dose of 5.27 mm medial rectus resection and 8.04 mm lateral rectus recession, a 7.11 ± 3.95 PD deviation was noted at the end of 6 months. Similarly, in group 2 with a mean surgical dose of 5.16 mm medial rectus plication and 8.16 mm lateral rectus recession, a 6.00 ± 2.46 PD deviation was noted at the end of 6 months. Between groups, ocular surface changes, inter-surgeon comparison, and exotropia subtypes did not reveal any significant differences.
Conclusion


In our observation, the reinforced medial rectus muscle plication showed clinically comparable results as compared to the standard resection procedure at the end of 6 months. Therefore, this innovative modification can be considered as an alternative to standard resection.",2022,"Between groups, ocular surface changes, inter-surgeon comparison, and exotropia subtypes did not reveal any significant differences.
","['patients with exotropia who underwent complete orthoptic evaluation followed by random assignment into two groups by using a computer-drawn random number table', 'A total of 80 patients were included in the study of which 39 were in group 1 and 41 in group 2', 'The mean age in group 1 was 23.48 ± 11.94 years and 23.29 ± 10.02 years in group 2']","['standard resection with recession procedure', 'reinforced plication of the medial rectus muscle to resection', 'reinforced plication with recession procedure', 'reinforced plication']","['mean preoperative deviation', 'surgical efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015310', 'cui_str': 'Exotropia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0029362', 'cui_str': 'Pleoptics'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0582820', 'cui_str': 'Medial rectus muscle structure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",80.0,0.017049,"Between groups, ocular surface changes, inter-surgeon comparison, and exotropia subtypes did not reveal any significant differences.
","[{'ForeName': 'Darshana', 'Initials': 'D', 'LastName': 'Daga', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Pujari', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi; Centre for Sight, New Delhi, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Phuljhele', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Saxena', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_2884_20']
2764,35225542,Multilayered inverted internal limiting membrane flap technique versus standard internal limiting membrane peeling for large macular holes: A comparative study.,"Purpose


To evaluate the outcome of vitrectomy with multilayered inverted internal limiting membrane flap technique (ML-IILM) versus vitrectomy with standard ILM peeling for large macular holes in terms of visual acuity and anatomical closure.
Methods


A hospital-based, prospective, randomized, interventional study was conducted during three calendar years with a total 150 eyes (75 in each group) in two groups-vitrectomy with ILM peeling (Group A) and vitrectomy with ML-IILM flap technique (Group B) after informed consent of study participants who met the inclusion criteria.
Results


The mean minimum and maximum diameter of macular hole did not differ statistically in both the groups. Macular hole index had no significant difference between both groups Pre-operative visual acuity was not statistically significantly different between the two groups. During follow-up, best corrected visual acuity (BCVA) at 1 month, 3 months, 6 months, and 12 months was significantly better in Group B (0.12 ± 0.07 at 1 month, 0.14 ± 0.10 at 3 months, 0.18 ± 0.11 at 6 months, and 0.19 ± 0.12 at 12 months) compared to Group A (0.20 ± 0.11 at 1 month, 0.22 ± 0.13 at 3 months, 0.30 ± 0.12 at 6 months, and 0.31 ± 0.14 at 12 months) (P = 0.001 for each). Type 1 anatomical closure (flattening of cuff and opposition of edges of hole) was achieved in 78.66% (59/75) cases in Group A and 93.33% (70/75) cases in Group B (P 0.0016).
Conclusion


Vitrectomy with multilayered inverted ILM flap technique had significantly higher anatomical closure and better visual outcome than vitrectomy with standard ILM peeling.",2022,Macular hole index had no significant difference between both groups Pre-operative visual acuity was not statistically significantly different between the two groups.,"['large macular holes', 'Group B) after informed consent of study participants who met the inclusion criteria', 'three calendar years with a total 150 eyes (75 in each group) in two groups']","['vitrectomy with standard ILM peeling', 'Multilayered inverted internal limiting membrane flap technique versus standard internal limiting membrane peeling', 'vitrectomy with multilayered inverted internal limiting membrane flap technique (ML-IILM) versus vitrectomy with standard ILM peeling', 'vitrectomy with ILM peeling (Group A) and vitrectomy with ML-IILM flap technique']","['Macular hole index', 'Type 1 anatomical closure (flattening of cuff and opposition of edges of hole', 'anatomical closure and better visual outcome', 'Pre-operative visual acuity', 'corrected visual acuity (BCVA', 'mean minimum and maximum diameter of macular hole']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0456586', 'cui_str': 'Calendar year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4522321', 'cui_str': 'Inverted'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0231519', 'cui_str': 'Diffuse rigidity'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",150.0,0.0267474,Macular hole index had no significant difference between both groups Pre-operative visual acuity was not statistically significantly different between the two groups.,"[{'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Agrawal', 'Affiliation': 'Department of Ophthalmology, SMS Medical College, Jaipur, Rajasthan, India.'}, {'ForeName': 'Khushbu', 'Initials': 'K', 'LastName': 'Jindal', 'Affiliation': 'Department of Ophthalmology, SMS Medical College, Jaipur, Rajasthan, India.'}, {'ForeName': 'Yogendra', 'Initials': 'Y', 'LastName': 'Dhakad', 'Affiliation': 'Department of Ophthalmology, SMS Medical College, Jaipur, Rajasthan, India.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Rathore', 'Affiliation': 'Department of Ophthalmology, AIIMS, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khilnani', 'Affiliation': 'Department of Ophthalmology, SMS Medical College, Jaipur, Rajasthan, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1530_21']
2765,35225536,Evaluation of macular and peripapillary vascular parameter change in healthy subjects after caffeine intake using optical coherence tomography angiography.,"Purpose


To observe the effects of caffeine intake on vessel densities in macular and peripapillary regions and to analyze the correlations of vascular properties of these two interlinked regions in healthy volunteers using optical coherence tomography angiography (OCTA).
Methods


In this prospective randomized, double-masked, placebo-controlled study, 120 participants were grouped into two groups: sixty subjects as a study group, which received caffeine and sixty subjects as a placebo group, which received a placebo. OCTA imaging was performed at baseline and 1 h after drug intake. Changes in macular and radial peripapillary capillary (RPC) vessel densities (VD) and foveal avascular zone (FAZ) parameters and correlation of these parameters were analyzed.
Results


Baseline macular and RPC VD and FAZ parameters showed no significant difference between study and placebo groups (P > 0.05 for all). VD parameters in all segments of superficial and deep macular regions and peripapillary region showed a statistically significant decrease after caffeine intake (P < 0.001 for all). All macular superficial VD parameters showed a positive correlation with deep perifovea VD (P < 0.05 for all). Also, superficial perifovea VD was positively correlated with all deep macular VD parameters except deep fovea VD (P < 0.05 for all).
Conclusion


We show that caffeine causes a decrease in macular and peripapillary vessel densities in healthy subjects, and correlations were observed between macular and peripapillary VD parameters. We believe that future studies are needed to support the effect of caffeine on peripapillary VD and the idea of using deep perifovea VD as the main parameter to estimate superficial macular parameters.",2022,VD parameters in all segments of superficial and deep macular regions and peripapillary region showed a statistically significant decrease after caffeine intake (P < 0.001 for all).,"['healthy subjects', '120 participants were grouped into two groups: sixty subjects as a study group, which received caffeine and sixty subjects as a', 'healthy volunteers']","['optical coherence tomography angiography', 'caffeine', 'placebo', 'optical coherence tomography angiography (OCTA', 'caffeine intake']","['Baseline macular and RPC VD and FAZ parameters', 'macular and peripapillary vessel densities', 'caffeine intake', 'macular and radial peripapillary capillary (RPC) vessel densities (VD) and foveal avascular zone (FAZ) parameters', 'superficial perifovea VD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0442163', 'cui_str': 'Peripapillary'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1275950', 'cui_str': 'Foveal avascular zone'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}]",120.0,0.0468327,VD parameters in all segments of superficial and deep macular regions and peripapillary region showed a statistically significant decrease after caffeine intake (P < 0.001 for all).,"[{'ForeName': 'Busra', 'Initials': 'B', 'LastName': 'Yilmaz Tugan', 'Affiliation': 'Department of Ophthalmology, Kocaeli University Medical Faculty, Kocaeli, Turkey.'}, {'ForeName': 'Sevgi', 'Initials': 'S', 'LastName': 'Subasi', 'Affiliation': 'Department of Ophthalmology, Kocaeli University Medical Faculty, Kocaeli, Turkey.'}, {'ForeName': 'Dilara', 'Initials': 'D', 'LastName': 'Pirhan', 'Affiliation': 'Department of Ophthalmology, Kocaeli University Medical Faculty, Kocaeli, Turkey.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Karabas', 'Affiliation': 'Department of Ophthalmology, Kocaeli University Medical Faculty, Kocaeli, Turkey.'}, {'ForeName': 'Nursen', 'Initials': 'N', 'LastName': 'Yuksel', 'Affiliation': 'Department of Ophthalmology, Kocaeli University Medical Faculty, Kocaeli, Turkey.'}, {'ForeName': 'Kubra Demirci', 'Initials': 'KD', 'LastName': 'Kucuk', 'Affiliation': 'Department of Ophthalmology, Kocaeli University Medical Faculty, Kocaeli, Turkey.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1989_21']
2766,35225906,Hybrid Hyaluronic Acid versus High Molecular Weight Hyaluronic Acid for the Treatment of Hip Osteoarthritis in Overweight/Obese Patients.,"BACKGROUND


Obesity is the main risk factor for hip osteoarthritis, negatively affecting the outcome of the disease. We evaluated the effectiveness of viscosupplementation with hybrid hyaluronic acid compared to that with high molecular weight hyaluronic acid in overweight/obese patients with hip osteoarthritis (OA).
METHODS


80 patients were divided into two groups: a treatment group received two ultrasound-guided intra-articular hip injections of hybrid HA 15 days apart; a control group received a single ultrasound-guided infiltration with medium-high molecular weight hyaluronic acid (1500-2000 kDa). We assessed the pain, functional and cardiovascular capacity of the patients at baseline, after 3 months, and after 6 months of the infiltrative sessions.
RESULTS


The treatment group showed greater improvements in the scores on the NRS scale (5.4 ± 0.8 vs. 6.3 ± 0.8;  p  &lt; 0.05) and in the Lequesne index (11.4 ± 2.6 vs. 13.6 ± 2.7;  p  &lt; 0.05) and in the distance traveled at 6MWT (238.1 ± 53.9 m vs. 210.7 ± 46.2 m;  p  = 0.02) both at 3 months (T1) and at 6 months (T2).
CONCLUSIONS


This study underlines the importance of exploiting the anti-inflammatory, analgesic, and chondrogenic properties of hybrid HA for the treatment of hip OA in overweight/obese patients.",2022,"The treatment group showed greater improvements in the scores on the NRS scale (5.4 ± 0.8 vs. 6.3 ± 0.8;  p  &lt; 0.05) and in the Lequesne index (11.4 ± 2.6 vs. 13.6 ± 2.7;  p  &lt; 0.05) and in the distance traveled at 6MWT (238.1 ± 53.9 m vs. 210.7 ± 46.2 m;  p  = 0.02) both at 3 months (T1) and at 6 months (T2).
","['overweight/obese patients with hip osteoarthritis (OA', 'Hip Osteoarthritis in Overweight/Obese Patients', 'hip OA in overweight/obese patients', '80 patients']","['ultrasound-guided intra-articular hip injections of hybrid HA 15 days apart; a control group received a single ultrasound-guided infiltration with medium-high molecular weight hyaluronic acid', 'viscosupplementation with hybrid hyaluronic acid', 'Hybrid Hyaluronic Acid versus High Molecular Weight Hyaluronic Acid', 'high molecular weight hyaluronic acid']","['pain, functional and cardiovascular capacity', 'NRS scale']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C2350507', 'cui_str': 'Viscosupplementation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",80.0,0.04557,"The treatment group showed greater improvements in the scores on the NRS scale (5.4 ± 0.8 vs. 6.3 ± 0.8;  p  &lt; 0.05) and in the Lequesne index (11.4 ± 2.6 vs. 13.6 ± 2.7;  p  &lt; 0.05) and in the distance traveled at 6MWT (238.1 ± 53.9 m vs. 210.7 ± 46.2 m;  p  = 0.02) both at 3 months (T1) and at 6 months (T2).
","[{'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Scaturro', 'Affiliation': 'Department of Surgical, Oncological and Stomatological Disciplines, University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Vitagliani', 'Affiliation': 'Faculty of Medicine and Surgery, University of Catania, 95100 Catania, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Terrana', 'Affiliation': 'Faculty of Medicine and Surgery, University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Tomasello', 'Affiliation': 'Faculty of Medicine and Surgery, University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Falco', 'Affiliation': 'Department of Economics and Statistics, University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Cuntrera', 'Affiliation': 'Department of Economics and Statistics, University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Italia', 'Initials': 'I', 'LastName': 'Spoto', 'Affiliation': 'Department of Biomedicine, Neuromedicine and Advanced Diagnostics, University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Midiri', 'Affiliation': 'Department of Biomedicine, Neuromedicine and Advanced Diagnostics, University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Letizia Mauro', 'Affiliation': 'Department of Surgical, Oncological and Stomatological Disciplines, University of Palermo, 90100 Palermo, Italy.'}]",Journal of functional morphology and kinesiology,['10.3390/jfmk7010020']
2767,35226163,"Laparoscopic definitive surgery for congenital biliary dilatation with aggressive hilar bile ductoplasty and complete resection of the intrapancreatic bile duct in pediatric patients is safe and effective, comparable to open surgery.","BACKGROUND


After surgery for congenital biliary dilatation (CBD), hilar and hepatic bile duct stenosis and intrapancreatic bile duct remnants can cause many postoperative complications. We investigated the efficacy of laparoscopic surgery with aggressive bile ductoplasty and complete excision of the intrapancreatic bile duct in CBD patients compared to open surgery.
METHODS


Pediatric patients who underwent surgery for CBD at our institution between 2006 and 2020 were divided into two groups: laparoscopic surgery (Lap group) and open surgery (Op group). Surgical outcomes were compared between the two groups.
RESULTS


We enrolled 160 patients (85 in the Lap group and 75 in the Op group). Hilar bile ductoplasty was performed in 52 (61%) patients from the Lap group and 40 (53%) patients from the Op group. The operative time was significantly longer, the amount of blood loss was significantly lower, and the length of hospital stay was significantly shorter in the Lap group than in the Op group. Postoperative early and late complications occurred at a similarly low rate in both groups. When the surgical outcomes were compared between the group who underwent laparoscopic bile ductoplasty and the group that did not, postoperative early and late complications occurred similarly in both groups.
CONCLUSIONS


Laparoscopic surgery for CBD with aggressive hilar bile ductoplasty and complete excision of the intrapancreatic bile duct is safe and effective, comparable to open surgery. However, it is necessary to verify whether long-term occurrence of hepatolithiasis similar to open definitive surgery can be obtained in the future.",2022,"The operative time was significantly longer, the amount of blood loss was significantly lower, and the length of hospital stay was significantly shorter in the Lap group than in the Op group.","['Pediatric patients who underwent surgery for CBD at our institution between 2006 and 2020', 'pediatric patients', 'CBD patients', '160 patients (85 in the Lap group and 75 in the Op group']","['laparoscopic surgery (Lap group) and open surgery (Op group', 'Laparoscopic definitive surgery', 'laparoscopic surgery', 'Laparoscopic surgery']","['blood loss', 'length of hospital stay', 'operative time', 'postoperative early and late complications', 'Postoperative early and late complications', 'Hilar bile ductoplasty']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C5200821', 'cui_str': 'Congenital Biliary Dilatation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0005388', 'cui_str': 'Bile'}]",160.0,0.0146918,"The operative time was significantly longer, the amount of blood loss was significantly lower, and the length of hospital stay was significantly shorter in the Lap group than in the Op group.","[{'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Tainaka', 'Affiliation': 'Department of Pediatric Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan. ttainaka@med.nagoya-u.ac.jp.'}, {'ForeName': 'Chiyoe', 'Initials': 'C', 'LastName': 'Shirota', 'Affiliation': 'Department of Pediatric Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.'}, {'ForeName': 'Akinari', 'Initials': 'A', 'LastName': 'Hinoki', 'Affiliation': 'Department of Pediatric Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Sumida', 'Affiliation': 'Department of Pediatric Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Yokota', 'Affiliation': 'Department of Pediatric Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Makita', 'Affiliation': 'Department of Pediatric Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.'}, {'ForeName': 'Hizuru', 'Initials': 'H', 'LastName': 'Amano', 'Affiliation': 'Department of Pediatric Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.'}, {'ForeName': 'Yujiro', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Pediatric Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.'}, {'ForeName': 'Hiroo', 'Initials': 'H', 'LastName': 'Uchida', 'Affiliation': 'Department of Pediatric Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan.'}]",Surgical endoscopy,['10.1007/s00464-022-09132-x']
2768,35226113,Does hyperbaric oxygen therapy facilitate peripheral nerve recovery in upper extremity injuries? A prospective study of 74 patients.,"PURPOSE


Several experimental studies have investigated the effects of hyperbaric oxygen therapy (HBOT) on peripheral nerve regeneration. However, to the best of our knowledge, clinical studies to evaluate the effects of HBOT on peripheral nerve recovery are seldom performed. The aim of our study was to investigate the efficacy of HBOT following primary nerve repair in patients with upper extremity nerve injuries.
METHODS


Patients admitted to our hospital between 2015 and 2019 with ulnar and median nerve injuries were included in the study. Patients were randomized based on their application dates and divided into two different groups. Patients who received HBOT following standard epineural nerve repair were included in group 1, while patients who only underwent epineural nerve repair were included in group 2. All patients were followed up at 3, 6, and 12 months post-treatment and evaluated through electroneuromyography analysis of the traumatized nerve, injured nerve-related muscle strength, and two-point discrimination test.
RESULTS


Impulse transmission of injured nerves to the end organ was faster in group 1. Further, ENMG parameters demonstrated that injured nerves of patients in group 1 recovered faster. Patients in group 1 also reached higher power score and had significantly more rapid motor recovery than patients in group 2.
CONCLUSION


This prospective study of upper extremity injuries demonstrated the favorable effects of HBOT on nerve recovery both clinically and electrophysiologically following nerve repair. One HBOT session each day for 5 days after surgical treatment can decrease morbidity and facilitate recovery.",2022,"Patients in group 1 also reached higher power score and had significantly more rapid motor recovery than patients in group 2.
","['Patients admitted to our hospital between 2015 and 2019 with ulnar and median nerve injuries were included in the study', 'patients with upper extremity nerve injuries', '74 patients']","['hyperbaric oxygen therapy', 'HBOT', 'hyperbaric oxygen therapy (HBOT']","['morbidity and facilitate recovery', 'rapid motor recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0161457', 'cui_str': 'Injury of median nerve'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1282341', 'cui_str': 'Peripheral nerve structure of upper limb'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}]",,0.0110344,"Patients in group 1 also reached higher power score and had significantly more rapid motor recovery than patients in group 2.
","[{'ForeName': 'Bilsev', 'Initials': 'B', 'LastName': 'Ince', 'Affiliation': 'Department of Plastic & Reconstructive and Aesthetic Surgery, Meram Faculty of Medicine, Necmettin Erbakan University, 42080, Konya, Turkey.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ismayilzada', 'Affiliation': 'Department of Plastic & Reconstructive and Aesthetic Surgery,, Istinye University, 34396, Istanbul, Turkey. mecidismayilzade@hotmail.com.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Arslan', 'Affiliation': 'Department of Hyperbaric and Underwater Medicine, Meram Faculty of Medicine, Necmettin Erbakan University, 42080, Konya, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Dadaci', 'Affiliation': 'Department of Plastic & Reconstructive and Aesthetic Surgery, Meram Faculty of Medicine, Necmettin Erbakan University, 42080, Konya, Turkey.'}]",European journal of trauma and emergency surgery : official publication of the European Trauma Society,['10.1007/s00068-022-01920-3']
2769,35226099,Efficacy and Safety of Enteral Recombinant Human Insulin in Preterm Infants: A Randomized Clinical Trial.,"Importance


Feeding intolerance is a common condition among preterm infants owing to immaturity of the gastrointestinal tract. Enteral insulin appears to promote intestinal maturation. The insulin concentration in human milk declines rapidly post partum and insulin is absent in formula; therefore, recombinant human (rh) insulin for enteral administration as a supplement to human milk and formula may reduce feeding intolerance in preterm infants.
Objective


To assess the efficacy and safety of 2 different dosages of rh insulin as a supplement to both human milk and preterm formula.
Design, Setting, and Participants


The FIT-04 multicenter, double-blind, placebo-controlled randomized clinical trial was conducted at 46 neonatal intensive care units throughout Europe, Israel, and the US. Preterm infants with a gestational age (GA) of 26 to 32 weeks and a birth weight of 500 g or more were enrolled between October 9, 2016, and April 25, 2018. Data were analyzed in January 2020.
Interventions


Preterm infants were randomly assigned to receive low-dose rh insulin (400-μIU/mL milk), high-dose rh insulin (2000-μIU/mL milk), or placebo for 28 days.
Main Outcomes and Measures


The primary outcome was time to achieve full enteral feeding (FEF) defined as an enteral intake of 150 mL/kg per day or more for 3 consecutive days.
Results


The final intention-to-treat analysis included 303 preterm infants (low-dose group: median [IQR] GA, 29.1 [28.1-30.4] weeks; 65 boys [59%]; median [IQR] birth weight, 1200 [976-1425] g; high-dose group: median [IQR] GA, 29.0 [27.7-30.5] weeks; 52 boys [55%]; median [IQR] birth weight, 1250 [1020-1445] g; placebo group: median [IQR] GA, 28.8 [27.6-30.4] weeks; 54 boys [55%]; median [IQR] birth weight, 1208 [1021-1430] g). The data safety monitoring board advised to discontinue the study early based on interim futility analysis (including the first 225 randomized infants), as the conditional power did not reach the prespecified threshold of 35% for both rh-insulin dosages. The study continued while the data safety monitoring board analyzed and discussed the data. In the final intention-to-treat analysis, the median (IQR) time to achieve FEF was significantly reduced in 94 infants receiving low-dose rh insulin (10.0 [7.0-21.8] days; P = .03) and in 82 infants receiving high-dose rh insulin (10.0 [6.0-15.0] days; P = .001) compared with 85 infants receiving placebo (14.0 [8.0-28.0] days). Compared with placebo, the difference in median (95% CI) time to FEF was 4.0 (1.0-8.0) days for the low-dose group and 4.0 (1.0-7.0) days for the high-dose group. Weight gain rates did not differ significantly between groups. Necrotizing enterocolitis (Bell stage 2 or 3) occurred in 7 of 108 infants (6%) in the low-dose group, 4 of 88 infants (5%) in the high-dose group, and 10 of 97 infants (10%) in the placebo group. None of the infants developed serum insulin antibodies.
Conclusions and Relevance


Results of this randomized clinical trial revealed that enteral administration of 2 different rh-insulin dosages was safe and compared with placebo, significantly reduced time to FEF in preterm infants with a GA of 26 to 32 weeks. These findings support the use of rh insulin as a supplement to human milk and preterm formula.
Trial Registration


ClinicalTrials.gov Identifier: NCT02510560.",2022,"Necrotizing enterocolitis (Bell stage 2 or 3) occurred in 7 of 108 infants (6%) in the low-dose group, 4 of 88 infants (5%) in the high-dose group, and 10 of 97 infants (10%) in the placebo group.","['Preterm infants with a gestational age (GA) of 26 to 32 weeks and a birth weight of 500 g or more were enrolled between October 9, 2016, and April 25, 2018', '303 preterm infants (low-dose group: median [IQR] GA, 29.1 [28.1-30.4] weeks; 65 boys [59%]; median [IQR] birth weight, 1200', 'preterm infants', 'preterm infants with a GA of 26 to 32 weeks', '46 neonatal intensive care units throughout Europe, Israel, and the US', 'group: median [IQR] GA, 28.8 [27.6-30.4] weeks; 54 boys [55%]; median [IQR] birth weight, 1208 [1021-1430] g', 'Preterm Infants', 'Interventions\n\n\nPreterm infants', 'preterm infants owing to immaturity of the gastrointestinal tract']","['placebo', 'rh insulin', 'Enteral Recombinant Human Insulin', 'Enteral insulin', 'low-dose rh insulin (400-μIU/mL milk), high-dose rh insulin (2000-μIU/mL milk), or placebo']","['Efficacy and Safety', 'Necrotizing enterocolitis', 'time to achieve full enteral feeding (FEF) defined as an enteral intake of 150 mL/kg per day or more for 3 consecutive days', 'median (IQR) time to achieve FEF', 'efficacy and safety', 'serum insulin antibodies', 'time to FEF', 'Weight gain rates']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0795635', 'cui_str': 'Regular Insulin, Human'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",303.0,0.473615,"Necrotizing enterocolitis (Bell stage 2 or 3) occurred in 7 of 108 infants (6%) in the low-dose group, 4 of 88 infants (5%) in the high-dose group, and 10 of 97 infants (10%) in the placebo group.","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Mank', 'Affiliation': ""Department of Pediatrics-Neonatology, Amsterdam UMC, University of Amsterdam, Vrije Universiteit Amsterdam, Emma Children's Hospital, Amsterdam, the Netherlands.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Sáenz de Pipaón', 'Affiliation': 'Department of Pediatrics-Neonatology, La Paz University Hospital, Autonoma University of Madrid, Madrid, Spain.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lapillonne', 'Affiliation': 'Department of Neonatology, Assistance Publique-Hôpitaux de Paris Necker-Enfants Malades Hospital, Paris University EHU 7328, Paris, France.'}, {'ForeName': 'Virgilio P', 'Initials': 'VP', 'LastName': 'Carnielli', 'Affiliation': 'Department of Pediatrics-Neonatology, Ospedali Riuniti di Ancona, Polytechnic University of Marche, Azienda Ospedaliero Universitaria, Ancona, Italy.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Senterre', 'Affiliation': 'Department of Pediatrics-Neonatology, Centre Hospitalier Régional de la Citadelle, University of Liège, Liège, Belgium.'}, {'ForeName': 'Raanan', 'Initials': 'R', 'LastName': 'Shamir', 'Affiliation': ""Schneider Children's Medical Center of Israel, Petah Tikva, Sackler Faculty of Medicine, Tel Aviv University, Israel.""}, {'ForeName': 'Letty', 'Initials': 'L', 'LastName': 'van Toledo', 'Affiliation': ""Department of Pediatrics-Neonatology, Amsterdam UMC, University of Amsterdam, Vrije Universiteit Amsterdam, Emma Children's Hospital, Amsterdam, the Netherlands.""}, {'ForeName': 'Johannes B', 'Initials': 'JB', 'LastName': 'van Goudoever', 'Affiliation': ""Department of Pediatrics-Neonatology, Amsterdam UMC, University of Amsterdam, Vrije Universiteit Amsterdam, Emma Children's Hospital, Amsterdam, the Netherlands.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA pediatrics,['10.1001/jamapediatrics.2022.0020']
2770,35226095,The Results of the Families Improving Together (FIT) for Weight Loss Randomized Trial in Overweight African American Adolescents.,"BACKGROUND


Few intervention studies have integrated cultural tailoring, parenting, behavioral, and motivational strategies to address African American adolescent weight loss.
PURPOSE


The Families Improving Together (FIT) for Weight Loss trial was a randomized group cohort study testing the efficacy of a cultural tailoring, positive parenting, and motivational intervention for weight loss in overweight African American adolescents (N = 241 adolescent/caregiver dyads).
METHODS


The trial tested an 8-week face-to-face group motivational plus family weight loss program (M + FWL) compared with a comprehensive health education control program. Participants were then rerandomized to an 8-week tailored or control online program to test the added effects of the online intervention on reducing body mass index and improving physical activity (moderate-to-vigorous physical activity [MVPA], light physical activity [LPA]), and diet.
RESULTS


There were no significant intervention effects for body mass index or diet. There was a significant effect of the group M + FWL intervention on parent LPA at 16 weeks (B = 33.017, SE = 13.115, p = .012). Parents in the group M + FWL intervention showed an increase in LPA, whereas parents in the comprehensive health education group showed a decrease in LPA. Secondary analyses using complier average causal effects showed a significant intervention effect at 16 weeks for parents on MVPA and a similar trend for adolescents.
CONCLUSIONS


While the intervention showed some impact on physical activity, additional strategies are needed to impact weight loss among overweight African American adolescents.",2022,"Parents in the group M + FWL intervention showed an increase in LPA, whereas parents in the comprehensive health education group showed a decrease in LPA.","['overweight African American adolescents', 'overweight African American adolescents (N = 241 adolescent/caregiver dyads', 'Overweight African American Adolescents']","['8-week face-to-face group motivational plus family weight loss program (M + FWL', 'comprehensive health education control program', 'cultural tailoring, positive parenting, and motivational intervention', 'online intervention on reducing body mass index and improving physical activity (moderate-to-vigorous physical activity [MVPA], light physical activity [LPA]), and diet']","['LPA', 'physical activity']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1096202', 'cui_str': 'Lipoprotein (a) measurement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",241.0,0.0102752,"Parents in the group M + FWL intervention showed an increase in LPA, whereas parents in the comprehensive health education group showed a decrease in LPA.","[{'ForeName': 'Dawn K', 'Initials': 'DK', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, Barnwell College, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Sweeney', 'Affiliation': 'College of Nursing, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'M Lee', 'Initials': 'ML', 'LastName': 'Van Horn', 'Affiliation': 'Department of Education, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Kitzman', 'Affiliation': 'Baylor Scott & White Health and Wellness Center, Dallas, TX, USA.'}, {'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Law', 'Affiliation': 'Department of Psychology, Barnwell College, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Haylee', 'Initials': 'H', 'LastName': 'Loncar', 'Affiliation': 'Department of Psychology, Barnwell College, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Colby', 'Initials': 'C', 'LastName': 'Kipp', 'Affiliation': 'Department of Psychology, Barnwell College, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Asia', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Department of Psychology, Barnwell College, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Quattlebaum', 'Affiliation': 'Department of Psychology, Barnwell College, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'McDaniel', 'Affiliation': 'Department of Psychology, Barnwell College, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'St George', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Prinz', 'Affiliation': 'Department of Psychology, Barnwell College, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior and Education School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaab110']
2771,35226053,Mindfulness-Oriented Recovery Enhancement vs Supportive Group Therapy for Co-occurring Opioid Misuse and Chronic Pain in Primary Care: A Randomized Clinical Trial.,"Importance


Successful treatment of opioid misuse among people with chronic pain has proven elusive. Guidelines recommend nonopioid therapies, but the efficacy of mindfulness-based interventions for opioid misuse is uncertain.
Objective


To evaluate the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE) for the reduction of opioid misuse and chronic pain.
Design, Setting, and Participants


This interviewer-blinded randomized clinical trial enrolled patients from primary care clinics in Utah between January 4, 2016, and January 16, 2020. The study included 250 adults with chronic pain receiving long-term opioid therapy who were misusing opioid medications.
Interventions


Treatment with MORE (comprising training in mindfulness, reappraisal, and savoring positive experiences) or supportive group psychotherapy (control condition) across 8 weekly 2-hour group sessions.
Main Outcomes and Measures


Primary outcomes were (1) opioid misuse assessed by the Drug Misuse Index (self-report, interview, and urine screen) and (2) pain severity and pain-related functional interference, assessed by subscale scores on the Brief Pain Inventory through 9 months of follow-up. Secondary outcomes were opioid dose, emotional distress, and ecological momentary assessments of opioid craving. The minimum intervention dose was defined as 4 or more completed sessions of MORE or supportive group psychotherapy.
Results


Among 250 participants (159 women [63.6%]; mean [SD] age, 51.8 [11.9] years), 129 were randomized to the MORE group and 121 to the supportive psychotherapy group. Overall, 17 participants (6.8%) were Hispanic or Latino, 218 (87.2%) were White, and 15 (6.0%) were of other races and/or ethnicities (2 American Indian, 3 Asian, 1 Black, 2 Pacific Islander, and 7 did not specify). At baseline, the mean duration of pain was 14.7 years (range, 1-60 years), and the mean (SD) morphine-equivalent opioid dose was 101.0 (266.3) mg (IQR, 16.0-90.0 mg). A total of 203 participants (81.2%) received the minimum intervention dose (mean [SD], 5.7 [2.2] sessions); at 9 months, 92 of 250 participants (36.8%) discontinued the study. The overall odds ratio for reduction in opioid misuse through the 9-month follow-up period in the MORE group compared with the supportive psychotherapy group was 2.06 (95% CI, 1.17-3.61; P = .01). At 9 months, 36 of 80 participants (45.0%) in the MORE group were no longer misusing opioids compared with 19 of 78 participants (24.4%) in the supportive psychotherapy group. Mixed models demonstrated that MORE was superior to supportive psychotherapy through 9 months of follow-up for pain severity (between-group effect: 0.49; 95% CI, 0.17-0.81; P = .003) and pain-related functional interference (between-group effect: 1.07; 95% CI, 0.64-1.50; P < .001). Participants in the MORE group reduced their opioid dose to a greater extent than those in the supportive psychotherapy group. The MORE group also had lower emotional distress and opioid craving.
Conclusions and Relevance


In this randomized clinical trial, among adult participants in a primary care setting, the MORE intervention led to sustained improvements in opioid misuse and chronic pain symptoms and reductions in opioid dosing, emotional distress, and opioid craving compared with supportive group psychotherapy. Despite attrition caused by the COVID-19 pandemic and the vulnerability of the sample, MORE appeared to be efficacious for reducing opioid misuse among adults with chronic pain.
Trial Registration


ClinicalTrials.gov Identifier: NCT02602535.",2022,"At 9 months, 36 of 80 participants (45.0%) in the MORE group were no longer misusing opioids compared with 19 of 78 participants (24.4%) in the supportive psychotherapy group.","[' mean [SD] age, 51.8 [11.9] years', '250 participants (159 women [63.6', 'enrolled patients from primary care clinics in Utah between January 4, 2016, and January 16, 2020', '250 adults with chronic pain receiving long-term opioid therapy who were misusing opioid medications', 'adults with chronic pain', 'Primary Care', '17 participants (6.8%) were Hispanic or Latino, 218 (87.2%) were White, and 15 (6.0%) were of other races and/or ethnicities ', 'adult participants in a primary care setting, the', 'people with chronic pain', '2 American Indian, 3 Asian, 1 Black, 2 Pacific Islander, and 7 did not specify']","['supportive group psychotherapy', 'Mindfulness-Oriented Recovery Enhancement vs Supportive Group Therapy', 'Mindfulness-Oriented Recovery Enhancement (MORE', 'MORE or supportive group psychotherapy', 'MORE', 'MORE intervention', 'supportive psychotherapy', 'MORE (comprising training in mindfulness, reappraisal, and savoring positive experiences) or supportive group psychotherapy (control condition']","['emotional distress and opioid craving', 'opioid misuse and chronic pain symptoms and reductions in opioid dosing, emotional distress, and opioid craving', 'longer misusing opioids', '1) opioid misuse assessed by the Drug Misuse Index (self-report, interview, and urine screen) and (2) pain severity and pain-related functional interference, assessed by subscale scores on the Brief Pain Inventory', 'opioid dose, emotional distress, and ecological momentary assessments of opioid craving', 'mean duration of pain', 'pain-related functional interference', 'overall odds ratio for reduction in opioid misuse', 'pain severity']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0042124', 'cui_str': 'Utah'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0242191', 'cui_str': 'Pacific Island Americans'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0338666', 'cui_str': 'Misuses drugs'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",250.0,0.460344,"At 9 months, 36 of 80 participants (45.0%) in the MORE group were no longer misusing opioids compared with 19 of 78 participants (24.4%) in the supportive psychotherapy group.","[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, College of Social Work, University of Utah, Salt Lake City.'}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Hanley', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, College of Social Work, University of Utah, Salt Lake City.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Pain Research Center, Division of Pain Medicine, Department of Anesthesiology, University of Utah School of Medicine, Salt Lake City.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Barrett', 'Affiliation': 'Community Physicians Group, University of Utah School of Medicine, Salt Lake City.'}, {'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Baker', 'Affiliation': 'Department of Anesthesiology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Reese', 'Affiliation': 'School of Social Work, University of Montana, Missoula.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Riquino', 'Affiliation': 'School of Social Welfare, University of Kansas, Lawrence.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Froeliger', 'Affiliation': 'Department of Psychology, University of Missouri, Columbia.'}, {'ForeName': 'Gary W', 'Initials': 'GW', 'LastName': 'Donaldson', 'Affiliation': 'Pain Research Center, Division of Pain Medicine, Department of Anesthesiology, University of Utah School of Medicine, Salt Lake City.'}]",JAMA internal medicine,['10.1001/jamainternmed.2022.0033']
2772,35226357,"A prediction model for early systemic recurrence in breast cancer using a molecular diagnostic analysis of sentinel lymph nodes: A large-scale, multicenter cohort study.","BACKGROUND


The one-step nucleic acid amplification (OSNA) assay can quantify the cytokeratin 19 messenger RNA copy number as a proxy for sentinel lymph node (SN) metastasis in breast cancer. A large-scale, multicenter cohort study was performed to determine the prognostic value of the SN tumor burden based on a molecular readout and to establish a model for the prediction of early systemic recurrence in patients using the OSNA assay.
METHODS


SN biopsies from 4757 patients with breast cancer were analyzed with the OSNA assay. The patients were randomly assigned to the training or validation cohort at a ratio of 2:1. On the basis of the training cohort, the threshold SN tumor burden value for stratifying distant recurrence was determined with Youden's index; predictors of distant recurrence were investigated via multivariable analyses. Based on the selected predictors, a model for estimating 5-year distant recurrence-free survival was constructed, and predictive performance was measured with the validation cohort.
RESULTS


The prognostic cutoff value for the SN tumor burden was 1100 copies/μL. The following variables were significantly associated with distant recurrence and were used to construct the prediction model: SN tumor burden, age, pT classification, grade, progesterone receptor, adjuvant cytotoxic chemotherapy, and adjuvant anti-human epidermal growth factor receptor 2 therapy. The values for the area under the curve, sensitivity, specificity, and accuracy of the prediction model were 0.83, 63.4%, 81.7%, and 81.1%, respectively.
CONCLUSIONS


Using the OSNA assay, the molecular readout-based SN tumor burden is an independent prognostic factor for early breast cancer. This model accurately predicts early systemic recurrence and may facilitate decision-making related to treatment.",2022,"The values for the area under the curve, sensitivity, specificity, and accuracy of the prediction model were 0.83, 63.4%, 81.7%, and 81.1%, respectively.
","['4757 patients with breast cancer', 'patients using the OSNA assay']",['OSNA assay'],"['values for the area under the curve, sensitivity, specificity, and accuracy of the prediction model', '5-year distant recurrence-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0534010', 'cui_str': 'One-Step dentin bonding system'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]","[{'cui': 'C0534010', 'cui_str': 'One-Step dentin bonding system'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",4757.0,0.0457728,"The values for the area under the curve, sensitivity, specificity, and accuracy of the prediction model were 0.83, 63.4%, 81.7%, and 81.1%, respectively.
","[{'ForeName': 'Tomo', 'Initials': 'T', 'LastName': 'Osako', 'Affiliation': 'Division of Pathology, Cancer Institute, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Matsuura', 'Affiliation': 'Division of Cancer Genomics, Cancer Institute, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yotsumoto', 'Affiliation': 'Department of Breast Surgery, Hakuaikai Sagara Hospital, Kagoshima, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Takayama', 'Affiliation': 'Department of Breast Surgery, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kaneko', 'Affiliation': 'Department of Breast Oncology, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.'}, {'ForeName': 'Kenzo', 'Initials': 'K', 'LastName': 'Shimazu', 'Affiliation': 'Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Katsuhide', 'Initials': 'K', 'LastName': 'Yoshidome', 'Affiliation': 'Department of Breast Surgery, Osaka Police Hospital, Osaka, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Kuraoka', 'Affiliation': 'Department of Diagnostic Pathology, National Hospital Organization Kure Medical Center/Chugoku Cancer Center, Hiroshima, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Itakura', 'Affiliation': 'Division of Breast and Endocrine Surgery, Shimane University Hospital, Shimane, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Tani', 'Affiliation': 'Department of Breast and Endocrine Surgery, Nihon University Hospital, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Breast Oncology and Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Yasuyo', 'Initials': 'Y', 'LastName': 'Ohi', 'Affiliation': 'Department of Pathology, Hakuaikai Sagara Hospital, Kagoshima, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Breast Surgery, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': 'Department of Breast Oncology, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Tsujimoto', 'Affiliation': 'Department of Pathology, Osaka Police Hospital, Osaka, Japan.'}, {'ForeName': 'Seigo', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Division of Breast Surgical Oncology, Department of Surgery, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Tsuda', 'Affiliation': 'Department of Basic Pathology, National Defense Medical College, Saitama, Japan.'}, {'ForeName': 'Shinzaburo', 'Initials': 'S', 'LastName': 'Noguchi', 'Affiliation': 'Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Futoshi', 'Initials': 'F', 'LastName': 'Akiyama', 'Affiliation': 'Division of Pathology, Cancer Institute, Japanese Foundation for Cancer Research, Tokyo, Japan.'}]",Cancer,['10.1002/cncr.34144']
2773,35226342,"Cerebello-Motor Paired Associative Stimulation and Motor Recovery in Stroke: a Randomized, Sham-Controlled, Double-Blind Pilot Trial.","Cerebellum is a key structure for functional motor recovery after stroke. Enhancing the cerebello-motor pathway by paired associative stimulation (PAS) might improve upper limb function. Here, we conducted a randomized, double-blind, sham-controlled pilot trial investigating the efficacy of a 5-day treatment of cerebello-motor PAS coupled with physiotherapy for promoting upper limb motor function compared to sham stimulation. The secondary objectives were to determine in the active treated group (i) whether improvement of upper limb motor function was associated with changes in corticospinal excitability or changes in functional activity in the primary motor cortex and (ii) whether improvements were correlated to the structural integrity of the input and output pathways. To that purpose, hand dexterity and maximal grip strength were assessed along with TMS recordings and multimodal magnetic resonance imaging, before the first treatment, immediately after the last one and a month later. Twenty-seven patients were analyzed. Cerebello-motor PAS was effective compared to sham in improving hand dexterity (p: 0.04) but not grip strength. This improvement was associated with increased activation in the ipsilesional primary motor cortex (p: 0.04). Moreover, the inter-individual variability in clinical improvement was partly explained by the structural integrity of the afferent (p: 0.06) and efferent pathways (p: 0.02) engaged in this paired associative stimulation (i.e., cortico-spinal and dentato-thalamo-cortical tracts). In conclusion, cerebello-motor-paired associative stimulation combined with physiotherapy might be a promising approach to enhance upper limb motor function after stroke.Clinical Trial Registration URL: http://www.clinicaltrials.gov . Unique identifier: NCT02284087.",2022,Cerebello-motor PAS was effective compared to sham in improving hand dexterity (p: 0.04) but not grip strength.,"['Twenty-seven patients were analyzed', 'Stroke']","['cerebello-motor PAS coupled with physiotherapy', 'Cerebello-Motor Paired Associative Stimulation and Motor Recovery', 'paired associative stimulation (PAS']","['structural integrity of the input and output pathways', 'hand dexterity and maximal grip strength', 'corticospinal excitability or changes in functional activity']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",27.0,0.222491,Cerebello-motor PAS was effective compared to sham in improving hand dexterity (p: 0.04) but not grip strength.,"[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Rosso', 'Affiliation': 'Institut du Cerveau - Paris Brain Institute - ICM, Inserm, CNRS, Sorbonne Université, Hôpital Pitié-Salpêtrière, Paris, France. charlotte.rosso@gmail.com.'}, {'ForeName': 'Eric Jr', 'Initials': 'EJ', 'LastName': 'Moulton', 'Affiliation': 'Institut du Cerveau - Paris Brain Institute - ICM, Inserm, CNRS, Sorbonne Université, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Kemlin', 'Affiliation': 'Institut du Cerveau - Paris Brain Institute - ICM, Inserm, CNRS, Sorbonne Université, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Leder', 'Affiliation': ""AP-HP, Urgences Cérébro-Vasculaires, Hôpital Pitié-Salpêtrière, DMU Neuroscience 6, 47-83 Boulevard de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Corvol', 'Affiliation': 'Institut du Cerveau - Paris Brain Institute - ICM, Inserm, CNRS, Sorbonne Université, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Sophien', 'Initials': 'S', 'LastName': 'Mehdi', 'Affiliation': 'Institut du Cerveau - Paris Brain Institute - ICM, Inserm, CNRS, Sorbonne Université, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Mickael A', 'Initials': 'MA', 'LastName': 'Obadia', 'Affiliation': 'Service de Neurologie, Fondation Rothschild, 75019, Paris, France.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Obadia', 'Affiliation': 'Service de Neurologie, Fondation Rothschild, 75019, Paris, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Yger', 'Affiliation': 'AP-HP, Hôpital Saint Antoine, Unité neurovasculaire, 75012, Paris, France.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Meseguer', 'Affiliation': 'AP-HP, Service de Neurologie, Hôpital Bichat, 75018, Paris, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Perlbarg', 'Affiliation': 'Centre de Neuro-Imagerie de Recherche, Institut du Cerveau, CENIR, Paris Brain Institute - ICM, 75013, Paris, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Valabregue', 'Affiliation': 'Centre de Neuro-Imagerie de Recherche, Institut du Cerveau, CENIR, Paris Brain Institute - ICM, 75013, Paris, France.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Magno', 'Affiliation': 'Institut du Cerveau - Paris Brain Institute - ICM, Inserm, CNRS, Sorbonne Université, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Lindberg', 'Affiliation': 'Inserm U894, Université Paris Descartes, 75013, Paris, France.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Meunier', 'Affiliation': 'Institut du Cerveau - Paris Brain Institute - ICM, Inserm, CNRS, Sorbonne Université, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Lamy', 'Affiliation': 'Institut du Cerveau - Paris Brain Institute - ICM, Inserm, CNRS, Sorbonne Université, Hôpital Pitié-Salpêtrière, Paris, France.'}]",Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics,['10.1007/s13311-022-01205-y']
2774,35226276,The Effect of Zinc Supplementation on the Improvement of Premenstrual Symptoms in Female University Students: a Randomized Clinical Trial Study.,"Zinc is an essential microelement that plays many important functions in the body. It is crucial for the regulation of cell growth, hormone release, immunological response, and reproduction. Thus, this trial aimed to evaluate the effects of zinc supplementation in comparison with placebo on the improvement of premenstrual symptoms in female university students. This triple-masked, randomized, placebo-controlled, parallel trial was conducted among 69 female students aged 18-35 with premenstrual syndrome that living in dormitories of Hamadan University of Medical Sciences, in west of Iran. Participants were randomly assigned to two groups of equal number; one group received 220 mg of elemental zinc (n = 33) and the other group received placebo (n = 36) on a regular daily for 24 weeks. The premenstrual syndrome was assessed by Premenstrual Symptoms Screening Tool-Adolescent (PSST-A) questionnaire for all participants. Chi-square and t-student tests were used to compare the percentage or mean of parameters between two groups. All statistical analysis conducted by SPSS version 16. The mean age in the intervention group was 25.64 [Formula: see text] 0.53 years, and in the control group was 24.38 [Formula: see text] 0.51 years (P = 0.087). After 24 weeks of intervention, PMS physical and psychological symptoms such as anger, anxiety, depressed mood, overeating, breast tenderness, headaches, muscle pain, bloating, and weight gain significantly decreased in zinc group compared to placebo group (P < 0.001). We observed a significant increase in relationship with friends, classmates, and coworkers (p = 0.003) after 24 weeks of intervention with zinc compared to placebo. In conclusion, zinc, as a simple and inexpensive treatment, was associated with improvement of PMS symptoms. Given that this is among the first studies to evaluate the effect of zinc supplementation on PMS, additional studies are warranted to confirm these findings.",2022,"We observed a significant increase in relationship with friends, classmates, and coworkers (p = 0.003) after 24 weeks of intervention with zinc compared to placebo.","['69 female students aged 18-35 with premenstrual syndrome that living in dormitories of Hamadan University of Medical Sciences, in west of Iran', 'Female University Students', 'female university students']","['zinc supplementation', '220\xa0mg of elemental zinc', 'placebo', 'Zinc Supplementation']","['PMS physical and psychological symptoms such as anger, anxiety, depressed mood, overeating, breast tenderness, headaches, muscle pain, bloating, and weight gain', 'premenstrual symptoms', 'premenstrual syndrome', 'PMS symptoms', 'Premenstrual Symptoms Screening Tool-Adolescent (PSST-A) questionnaire', 'Premenstrual Symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0020505', 'cui_str': 'Overeating'}, {'cui': 'C0262397', 'cui_str': 'Breast tenderness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0232959', 'cui_str': 'Premenstrual symptom'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0858285,"We observed a significant increase in relationship with friends, classmates, and coworkers (p = 0.003) after 24 weeks of intervention with zinc compared to placebo.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Fatemieh Hospital, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Shahedeh', 'Initials': 'S', 'LastName': 'Khansary', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Fatemieh Hospital, Hamadan University of Medical Sciences, Hamadan, Iran. Dr_sh_kh@yahoo.com.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Parsapour', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Fatemieh Hospital, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Alizamir', 'Affiliation': 'Department of Pathology, School of Medicine, Fatemieh Hospital, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Azar', 'Initials': 'A', 'LastName': 'Pirdehghan', 'Affiliation': 'Department of Community Medicine, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Biological trace element research,['10.1007/s12011-022-03175-w']
2775,35228117,Six-month outcomes of the CODES randomised controlled trial of cognitive behavioural therapy for dissociative seizures: A secondary analysis.,"PURPOSE


The CODES Trial for adults with dissociative seizures had a predesignated 12-month post-randomisation follow-up point for outcome evaluation. We undertook an exploratory, unplanned, secondary analysis to evaluate the effectiveness of cognitive behavioural therapy plus standardised medical care (CBT+SMC) compared to SMC alone at 6 months post-randomisation, i.e., closer to the end of treatment.
METHODS


The analysis of 6-month data followed our previous method of using multiple imputation and an intention-to-treat approach to analyse variables 12 months post-randomisation.
RESULTS


The original trial primary outcome of monthly seizure frequency showed greater benefit from CBT+SMC than SMC-alone at 6 months (at p < 0.05). Of 13 comparable previously-defined secondary outcomes, 12 showed a significant between group effect (p < 0.05) in favour of the CBT intervention at 6 months. The average effect size of the comparable previously-defined primary and secondary continuous outcomes was 0.33 at 6 months vs 0.26 at 12 months. The estimated Incidence Rate Ratio (IRR) quantifying monthly seizure reduction was IRR = 0.72 (95%CI from 0.55 to 0.93) at 6 months compared to IRR = 0.78 at 12 months.
CONCLUSION


DS-specific CBT (plus SMC) produced evidence of significant benefits at 6 months post- randomisation (around which time CBT was complete) compared to SMC alone; for the majority of these outcomes, better results following CBT (plus SMC) had previously been reported at 12 months. Our pattern of results suggests that short- and longer-term follow-ups are necessary to understand treatment effects in this disorder. Studies only providing short-term follow-up data should be interpreted with caution.",2022,"Of 13 comparable previously-defined secondary outcomes, 12 showed a significant between group effect (p < 0.05) in favour of the CBT intervention at 6 months.","['adults with dissociative seizures', 'dissociative seizures']","['DS-specific CBT (plus SMC', 'CBT (plus SMC', 'CBT+SMC', 'cognitive behavioural therapy plus standardised medical care (CBT+SMC', 'cognitive behavioural therapy']","['monthly seizure frequency', 'estimated Incidence Rate Ratio (IRR) quantifying monthly seizure reduction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",13.0,0.195705,"Of 13 comparable previously-defined secondary outcomes, 12 showed a significant between group effect (p < 0.05) in favour of the CBT intervention at 6 months.","[{'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': ""Department of Psychology, King's College London, Institute of Psychiatry, Psychology and Neuroscience, DeCrespigny Park, London SE5 8AF, UK. Electronic address: Laura.goldstein@kcl.ac.uk.""}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Robinson', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, UK; Research Data and Statistics Unit, Royal Marsden Clinical Trials Unit, The Royal Marsden NHS Foundation Trust, Surrey, UK. Electronic address: emily.robinson@rmh.nhs.uk.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Department of Psychological Medicine, King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK. Electronic address: trudie.chalder@kcl.ac.uk.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Reuber', 'Affiliation': 'Academic Neurology Unit, Royal Hallamshire Hospital, University of Sheffield, Sheffield, UK. Electronic address: m.reuber@sheffield.ac.uk.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Medford', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK. Electronic address: nick.medford@slam.nhs.uk.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, UK. Electronic address: jon.stone@ed.ac.uk.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Carson', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, UK. Electronic address: a.carson@ed.ac.uk.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Centre for Social Justice and Global Responsibility, School of Law and Social Sciences, London South Bank University, London, UK. Electronic address: EdMicheleMoore@gmail.com.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK. Electronic address: sabine.landau@kcl.ac.uk.""}]",Seizure,['10.1016/j.seizure.2022.01.016']
2776,35228574,A sex- and gender-based analysis of factors associated with linear growth in infants in Ecuadorian Andes.,"Although female infants may have an early life biological advantage over males, gendered treatment can alter health outcomes. Ecuador has an unusually high ratio of male to female infant mortality, but gender norms have been reported to favor boys. This analysis of baseline data from the Lulun Project, a randomized controlled trial conducted in rural Andean communities of Ecuador, investigates the roles of sex and gender in undernutrition among infants 6 to 9 months of age. Twenty-four-hour recall frequencies were used to assess dietary intake. Food outcome models were analyzed as prevalence ratios calculated using a binomial distribution with a log link or robust Poisson regression. Linear regression was used to analyze the continuous growth outcome length-for-age z score. Socioeconomic and health history variables were comparable between male and female infants. Boys were more often fed liquids other than breastmilk within their first 3 days of life (17.1% vs. 5.2%, P = 0.026). Compared with girls, boys were less likely to be fed eggs by 33% (95% CI 0.46, 0.96), cheese, yogurt, or other milk products by 40% (95% CI 0.39, 0.92), yellow fruit by 44% (95% CI 0.33, 0.97), water by 37% (95% CI 0.45, 0.88), thin porridge by 29% (95% CI 0.56, 0.92), and tea without milk by 67% (95% CI 0.11, 0.99). Prevalence of boys with an adequate dietary diversity score (≥ 4) was reduced by 27% relative to girls (95% CI 0.54, 0.99). Males fared worse in length-for-age z scores (- 2.16 vs. - 1.56, P = 0.000), weight-for-age z scores (- 0.86 vs. - 0.33, P = 0.002), prevalence of stunting (50.6% vs. 23.4%, P = 0.000), and plasma concentrations of dimethylglycine (1.25 vs. 1.65 µg/mL, P = 0.021). After adjusting for demographic, caregiver perceptions of appetite, and biological factors, length-for-age z score for a male child was 0.62 units lower than for a female (95% CI - 0.98, - 0.26). Male infants were shown to receive lower quality complementary foods and have worse anthropometric measures than female infants.Trial registration clinicaltrials.gov, NCT02446873. Registered February 28, 2015, https://clinicaltrials.gov/ct2/show/NCT02446873 .",2022,"Males fared worse in length-for-age z scores (- 2.16 vs. - 1.56, P = 0.000), weight-for-age z scores (- 0.86 vs. - 0.33, P = 0.002), prevalence of stunting (50.6% vs. 23.4%, P = 0.000), and plasma concentrations of dimethylglycine (1.25 vs. 1.65 µg/mL, P = 0.021).","['infants in Ecuadorian Andes', 'Male infants', 'male and female infants', 'rural Andean communities of Ecuador, investigates the roles of sex and gender in undernutrition among infants 6 to 9\xa0months of age', 'female infants']",[],"['outcome length-for-age z score', 'plasma concentrations of dimethylglycine', 'length-for-age z scores', 'yellow fruit', 'weight-for-age z scores', 'Socioeconomic and health history variables', 'demographic, caregiver perceptions of appetite, and biological factors, length-for-age z score', 'prevalence of stunting']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0013593', 'cui_str': 'Ecuador'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0058265', 'cui_str': 'dimethylglycine'}, {'cui': 'C0221205', 'cui_str': 'Yellow color'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0455458', 'cui_str': 'PMH - past medical history'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}]",,0.344954,"Males fared worse in length-for-age z scores (- 2.16 vs. - 1.56, P = 0.000), weight-for-age z scores (- 0.86 vs. - 0.33, P = 0.002), prevalence of stunting (50.6% vs. 23.4%, P = 0.000), and plasma concentrations of dimethylglycine (1.25 vs. 1.65 µg/mL, P = 0.021).","[{'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Evers', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO, USA. emily.evers@wustl.edu.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Waters', 'Affiliation': 'Instituto de Investigación en Salud Y Nutrición, Universidad San Francisco de Quito, Quito, Ecuador.'}, {'ForeName': 'Carlos Andres', 'Initials': 'CA', 'LastName': 'Gallegos-Riofrío', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Chessa K', 'Initials': 'CK', 'LastName': 'Lutter', 'Affiliation': 'RTI International, Washington, DC, USA.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Iannotti', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, MO, USA.'}]",Scientific reports,['10.1038/s41598-022-06806-3']
2777,35228493,Effectiveness of Textured Soybean Protein on Blood Biochemistry in Vietnamese Type 2 Diabetes Mellitus Patients.,"Type 2 diabetes mellitus (T2DM) has been increasing rapidly in Vietnam as well as world-wide. One of the major causes of the condition is low fiber intake. It is difficult to eat large amounts of vegetables every day to reach a sufficient amount of fiber but Textured Soybean Protein is rich in fiber. The study aimed to examine the effectiveness of Textured Soybean Protein consumption on T2DM patients. In this randomized controlled trial, 47 T2DM patients were divided into an intervention group (n=24) and a control group (n=23). The intervention group were asked to consume 40 g Textured Soybean Protein in 2 dishes for 4 wk. The control group continued their usual diet. Fasting blood samples were drawn before and after intervention to measure fasting plasma glucose (FPG), fructosamine, low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), total cholesterol (T-C), and triglycerides (TG). A 3-day food record was conducted at 1 wk before (baseline) and at the last week (final) of the intervention period. In the Textured Soybean Protein consumption group, there was a significant decrease in fructosamine (363±86 μmol/L to 347±82 μmol/L, p=0.03), T-C (5.2±0.9 mmol/L to 4.8±0.8 mmol/L, p=0.02) and TG (3.5±2.2 mmol/L to 2.8±2.0 mmol/L, p=0.02). Total energy intake in the two groups did not change significantly. There was a shift in the dietary pattern of the Textured Soybean Protein consumption group; lipid intake showed a significant decrease (p=0.001) and fiber intake increased by 6 g (p<0.001). The consumption of Textured Soybean Protein in the diet could have favorable effects in improving glycemic and lipid concentrations in T2DM patients.",2022,There was a shift in the dietary pattern of the Textured Soybean Protein consumption group; lipid intake showed a significant decrease (p=0.001) and fiber intake increased by 6 g (p<0.001).,"['Vietnamese Type 2 Diabetes Mellitus Patients', 'T2DM patients', '47 T2DM patients', 'Type 2 diabetes mellitus (T2DM']","['Textured Soybean Protein', 'Textured Soybean Protein consumption', 'consume 40 g Textured Soybean Protein']","['glycemic and lipid concentrations', 'fiber intake', 'Total energy intake', 'fructosamine', 'fasting plasma glucose (FPG), fructosamine, low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), total cholesterol (T-C), and triglycerides (TG', 'Fasting blood samples', 'Blood Biochemistry']","[{'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0950114', 'cui_str': 'Soy Bean Proteins'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}]",47.0,0.00900623,There was a shift in the dietary pattern of the Textured Soybean Protein consumption group; lipid intake showed a significant decrease (p=0.001) and fiber intake increased by 6 g (p<0.001).,"[{'ForeName': 'Ngoc Thi', 'Initials': 'NT', 'LastName': 'Ta', 'Affiliation': 'Department of International Nutrition, Jumonji University Graduate School of Human Life Sciences.'}, {'ForeName': 'Hien Thi Thu', 'Initials': 'HTT', 'LastName': 'Ngo', 'Affiliation': 'Department of International Nutrition, Jumonji University Graduate School of Human Life Sciences.'}, {'ForeName': 'Phuong Mai', 'Initials': 'PM', 'LastName': 'Nguyen', 'Affiliation': 'Department of International Nutrition, Jumonji University Graduate School of Human Life Sciences.'}, {'ForeName': 'Thu Thi', 'Initials': 'TT', 'LastName': 'Truong', 'Affiliation': 'Department of Food and Nutrition, Hai Duong Medical Technical University.'}, {'ForeName': 'Giang Huong', 'Initials': 'GH', 'LastName': 'Nguyen', 'Affiliation': 'Department of International Nutrition, Jumonji University Graduate School of Human Life Sciences.'}, {'ForeName': 'Hang Thi Dieu', 'Initials': 'HTD', 'LastName': 'Dinh', 'Affiliation': 'Hai Duong Medical Technical University.'}, {'ForeName': 'Linh Thuy', 'Initials': 'LT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Nutrition, Hanoi Medical University Hospital.'}, {'ForeName': 'Huong Thi', 'Initials': 'HT', 'LastName': 'LE', 'Affiliation': 'Department of Nutrition, Hanoi Medical University Hospital.'}, {'ForeName': 'Khan Cong', 'Initials': 'KC', 'LastName': 'Nguyen', 'Affiliation': 'Hai Duong Medical Technical University.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of International Nutrition, Jumonji University Graduate School of Human Life Sciences.'}]",Journal of nutritional science and vitaminology,['10.3177/jnsv.68.32']
2778,35228490,Role of Vitamin D Supplementation in Improving Cytokine Profile in Patients of Non-ST-Elevation Acute Coronary Syndrome.,"Sub endothelial infarcts leads to non-ST-elevation acute coronary syndrome. Proinflammatory cytokines are raised in serum, the severity of which is a poor prognostic sign. Vitamin D deficiency is prevalent among patients of ACS. Vitamin D has immunomodulatory roles having effects on various aspects of inflammation. A total of 40 patients were divided into experimental (n=20) and control (n=20) groups. Experimental group was given single dose of vitamin D 200,000 IU. They were assessed for baseline C-reactive protein, interleukin-6, tumor necrosis factor-α levels by using sandwich ELISA technique. Four months after intervention resampling was done for the same parameters. Findings were expressed as mean±SD. Independent sample t-test was used to compare effect of vitamin D intervention between control group and intervention group. p-value of ≤0.05 was considered to be significant. The serum C-reactive protein showed significant reduction (p=0.028*) after intervention with vitamin D. Serum interleukin-6 (p=0.848), tumor necrosis factor-α (p=0.20) were decreased non-significantly in experimental as compared to the control group. It was concluded that a single large dose of vitamin D was able to reduce the C-reactive protein in non-ST-elevation acute coronary syndrome patients while non-significant reductions in interleukin-6 and tumor necrosis factor-α were observed.",2022,"The serum C-reactive protein showed significant reduction (p=0.028*) after intervention with vitamin D. Serum interleukin-6 (p=0.848), tumor necrosis factor-α (p=0.20) were decreased non-significantly in experimental as compared to the control group.","['Patients of Non-ST-Elevation Acute Coronary Syndrome', '40 patients were divided into experimental (n=20) and control (n=20) groups', 'patients of ACS']","['Vitamin D', 'Vitamin D Supplementation', 'vitamin D 200,000 IU', 'vitamin D intervention', 'vitamin D']","['interleukin-6 and tumor necrosis factor-α', 'C-reactive protein', 'tumor necrosis factor-α', 'baseline C-reactive protein, interleukin-6, tumor necrosis factor-α levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",40.0,0.0424495,"The serum C-reactive protein showed significant reduction (p=0.028*) after intervention with vitamin D. Serum interleukin-6 (p=0.848), tumor necrosis factor-α (p=0.20) were decreased non-significantly in experimental as compared to the control group.","[{'ForeName': 'Sidra', 'Initials': 'S', 'LastName': 'Jabeen', 'Affiliation': 'Department of Physiology, Islamic International Medical College.'}, {'ForeName': 'Humaira Fayyaz', 'Initials': 'HF', 'LastName': 'Khan', 'Affiliation': 'Department of Physiology, Islamic International Medical College.'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Physiology, Islamic International Medical College.'}, {'ForeName': 'Abdul Hamid', 'Initials': 'AH', 'LastName': 'Siddique', 'Affiliation': 'Head of Cardiology Department, Armed Forces Institute of Cardiology/National Institute of Heart Diseases.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Majeed', 'Affiliation': 'Department of Physiology, Islamic International Medical College.'}, {'ForeName': 'Saira', 'Initials': 'S', 'LastName': 'Safder', 'Affiliation': 'Department of Physiology, Islamic International Medical College.'}, {'ForeName': 'Fozia', 'Initials': 'F', 'LastName': 'Shamshad', 'Affiliation': 'Department of Physiology, Islamic International Medical College.'}]",Journal of nutritional science and vitaminology,['10.3177/jnsv.68.1']
2779,35229253,Active and sham transcranial direct current stimulation (tDCS) improved quality of life in female patients with fibromyalgia.,"PURPOSE


Fibromyalgia (FM) is a chronic pain syndrome with a strong impact on quality of life (QoL). Treatment of this condition remains a challenge, due to the scarce evidence for the effectiveness of the therapeutic approaches available. Current attention is focused on transcranial direct current stimulation (tDCS), which has yielded promising results for pain treatment. Rather than focusing only on pain relief, in this study, we aimed to determine how active or sham tDCS (over three cortical targets -the primary motor cortex, the dorsolateral prefrontal cortex and the operculo-insular cortex-) affect QoL in patients with FM.
METHODS


Using a double-blind, placebo-controlled design, we applied fifteen tDCS sessions of 20' to initial 130 participants (randomized to any of the four treatment groups). We evaluated the QoL (assessed by SF-36) and the symptoms' impact (assessed by FIQ-R) in baseline, after treatment and at 6 months follow-up.
RESULTS


All groups were comparable as regards age, medication pattern and severity of symptoms before the treatment. We found that QoL and symptoms' impact improved in all treatment groups (including the sham) and this improvement lasted for up to 6 months. However, we did not observe any group effect nor group*treatment interaction.
CONCLUSIONS


After the intervention, we observed a non-specific effect that may be due to placebo, favoured by the expectations of tDCS efficacy and psychosocial variables inherent to the intervention (daily relationship with therapists and other patients in the clinic). Therefore, active tDCS is not superior to sham stimulation in improving QoL in FM.",2022,We found that QoL and symptoms' impact improved in all treatment groups (including the sham) and this improvement lasted for up to 6 months.,['female patients with fibromyalgia'],"['Active and sham transcranial direct current stimulation (tDCS', 'transcranial direct current stimulation (tDCS', 'sham tDCS', 'placebo']","['pain relief', 'quality of life (QoL', ""QoL and symptoms' impact"", 'quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",,0.162514,We found that QoL and symptoms' impact improved in all treatment groups (including the sham) and this improvement lasted for up to 6 months.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Samartin-Veiga', 'Affiliation': 'Brain and Pain (BaP) Lab, Departamento de Psicoloxía Clínica y Psicobioloxía, Facultade de Psicoloxia, Universidade de Santiago de Compostela, Campus Vida, 15782, Santiago de Compostela, A Coruña, Spain. noelia.samartin.veiga@usc.es.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'González-Villar', 'Affiliation': 'Psychological Neuroscience Lab, Research Center in Psychology, School of Psychology, University of Minho, Braga, Portugal.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pidal-Miranda', 'Affiliation': 'Brain and Pain (BaP) Lab, Departamento de Psicoloxía Clínica y Psicobioloxía, Facultade de Psicoloxia, Universidade de Santiago de Compostela, Campus Vida, 15782, Santiago de Compostela, A Coruña, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vázquez-Millán', 'Affiliation': 'Brain and Pain (BaP) Lab, Departamento de Psicoloxía Clínica y Psicobioloxía, Facultade de Psicoloxia, Universidade de Santiago de Compostela, Campus Vida, 15782, Santiago de Compostela, A Coruña, Spain.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Carrillo-de-la-Peña', 'Affiliation': 'Brain and Pain (BaP) Lab, Departamento de Psicoloxía Clínica y Psicobioloxía, Facultade de Psicoloxia, Universidade de Santiago de Compostela, Campus Vida, 15782, Santiago de Compostela, A Coruña, Spain.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-022-03106-1']
2780,35229220,A randomized controlled trial to evaluate the effectiveness of different methods on pain management during orthodontic debonding.,"BACKGROUND


Orthodontic treatment procedures like separator placement, archwire placement, orthodontic force application, miniscrew placement and debonding procedure usually involve pain and discomfort. Pain perception and methods to reduce pain during debonding in regard to gender and different locations of oral cavity is still a poorly documented issue in orthodontics. The aim of this study was to evaluate the effectiveness of different methods on pain management during debonding and its association with gender and location.
MATERIALS AND METHODS


One hundred and forty orthodontic patients in the stage of debonding were randomly assigned into four groups according to different methods used during debonding; Group A: Medication group (Paracetamol given 1 h before debonding), Group B: Finger pressure group, Group C: Stress relief group and Group D: Control group. A visual analog scale (VAS) was used to assess the pain intensity just after debonding for each sextant.
RESULTS


Among 140 participants, 61 (43.57%) were males and 79 (56.43%) were females. Differences in VAS score in different areas of oral cavity among all groups were found to be significant (p < 0.05). Total VAS score was greater in control group (16.67) followed by stress relief group (13.33) and finger pressure group (10) and least in medication group (8.33). The VAS score was higher in the upper front and lower front sextants in all the groups. Females reported higher VAS score and in upper front sextant, it showed significant difference (p = 0.018). On comparison, total VAS scores were statistically significant difference in medication-stress relief arm pair (p = 0.009), medication-control arm pair (p < 0.001) and finger pressure-control arm pair (0.002). The total VAS score comparison between medication-finger pressure arm was not significant (p = 0.172).
CONCLUSIONS


Pain perceived during debonding varies in different areas of oral cavity among all the groups. Anterior area of oral cavity and female seems to be more sensitive to pain. Use of finger pressure can be used effectively for pain management during debonding.",2022,Total VAS score was greater in control group (16.67) followed by stress relief group (13.33) and finger pressure group (10) and least in medication group (8.33).,"['140 participants, 61 (43.57%) were males and 79 (56.43%) were females', 'One hundred and forty orthodontic patients in the stage of debonding']","['Medication group (Paracetamol given 1\xa0h before debonding), Group B: Finger pressure group, Group C: Stress relief group and Group D: Control group']","['pain', 'pain management', 'total VAS scores', 'total VAS score', 'VAS score', 'visual analog scale (VAS', 'pain intensity', 'Pain perception', 'Total VAS score']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",140.0,0.0492613,Total VAS score was greater in control group (16.67) followed by stress relief group (13.33) and finger pressure group (10) and least in medication group (8.33).,"[{'ForeName': 'Sanjay Prasad', 'Initials': 'SP', 'LastName': 'Gupta', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Tribhuvan University Dental Teaching Hospital, Maharajgunj Medical Campus, Institute of Medicine, Tribhuvan University, Maharajgunj, Kathmandu, Nepal. sanjayagupta2000@gmail.com.'}, {'ForeName': 'Shristi', 'Initials': 'S', 'LastName': 'Rauniyar', 'Affiliation': 'Dental Villa-Orthodontic Center & Speciality Dental Clinic, Balkhu, Kathmandu, Nepal.'}, {'ForeName': 'Pravin', 'Initials': 'P', 'LastName': 'Prasad', 'Affiliation': 'Department of Clinical Pharmacology, Maharajgunj Medical Campus, Institute of Medicine, Tribhuvan University, Maharajgunj, Kathmandu, Nepal.'}, {'ForeName': 'Pranil Man Singh', 'Initials': 'PMS', 'LastName': 'Pradhan', 'Affiliation': 'Department of Community Medicine, Maharajgunj Medical Campus, Institute of Medicine, Tribhuvan University, Maharajgunj, Kathmandu, Nepal.'}]",Progress in orthodontics,['10.1186/s40510-022-00401-y']
2781,35229141,Olaparib in patients with mCRPC with homologous recombination repair gene alterations: PROfound Asian subset analysis.,"BACKGROUND


The Phase III PROfound study (NCT02987543) evaluated olaparib versus abiraterone or enzalutamide (control; randomized 2:1 to olaparib or control) in men with homologous recombination repair gene alterations and metastatic castration-resistant prostate cancer whose disease progressed on prior next-generation hormonal agent.
METHODS


We present efficacy and safety data from an exploratory post hoc analysis of olaparib in the PROfound Asian subset. Analyses were not planned, alpha controlled or powered. Of 101 Asian patients enrolled in Japan (n=57), South Korea (n=29) and Taiwan (n=15), 66 and 35 patients received olaparib and control, respectively.
RESULTS


Radiographic progression-free survival (rPFS) and overall survival (OS) favored olaparib versus control in Cohort A [rPFS 7.2 vs. 4.5 months, HR 0.58, 95% CI 0.29-1.21, P = 0.14 (nominal); OS 23.4 vs. 17.8 months, HR 0.81, 95% CI 0.40-1.74, P = 0.57 (nominal)] and Cohorts A+B [rPFS 5.8 vs. 3.5 months, HR 0.69, 95% CI 0.42-1.16, P = 0.13 (nominal); OS 18.6 vs. 16.2 months, HR 0.96, 95% CI 0.56-1.70, P = 0.9 (nominal)]. Olaparib showed greatest improvement in patients harboring BRCA alterations [rPFS 9.3 vs. 3.5 months, HR 0.17, 95% CI 0.06-0.49, P = 0.0003 (nominal); OS 26.8 vs. 14.3 months, HR 0.62, 95% CI 0.24-1.79, P = 0.34 (nominal)]. Safety data were consistent with the known profile of olaparib, with no new safety signals identified.
CONCLUSION


In PROfound, there was a statistically significant improvement in outcomes reported in the global population of patients with metastatic castration-resistant prostate cancer and alterations in homologous recombination repair genes whose disease progressed on prior next-generation hormonal agent compared with control. For the subset of Asian patients reported here, exploratory analysis suggested that there was also an improvement in outcomes versus control. The safety and tolerability of olaparib in Asian patients were similar to that of the PROfound global population.
CLINICAL TRIAL NUMBER


ClinicalTrials.gov NCT02987543.",2022,"[rPFS 7.2 vs. 4.5 months, HR 0.58, 95% CI 0.29-1.21, P = 0.14 (nominal); OS 23.4 vs. 17.8 months, HR 0.81, 95% CI 0.40-1.74, P = 0.57 (nominal)] and Cohorts A+B [rPFS 5.8 vs. 3.5 months, HR 0.69, 95% CI 0.42-1.16, P = 0.13 (nominal); OS 18.6 vs. 16.2 months, HR 0.96, 95% CI 0.56-1.70, P = 0.9 (nominal)].","['men with homologous recombination repair gene alterations and metastatic castration-resistant prostate cancer whose disease progressed on prior next-generation hormonal agent', 'patients with mCRPC with homologous recombination repair gene alterations', '101 Asian patients enrolled in Japan (n=57), South Korea (n=29) and Taiwan (n=15), 66 and 35 patients received olaparib and control, respectively', 'Asian patients']","['olaparib or control', 'olaparib versus abiraterone or enzalutamide', 'Olaparib']","['Radiographic progression-free survival (rPFS) and overall survival (OS', 'safety and tolerability']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",101.0,0.231242,"[rPFS 7.2 vs. 4.5 months, HR 0.58, 95% CI 0.29-1.21, P = 0.14 (nominal); OS 23.4 vs. 17.8 months, HR 0.81, 95% CI 0.40-1.74, P = 0.57 (nominal)] and Cohorts A+B [rPFS 5.8 vs. 3.5 months, HR 0.69, 95% CI 0.42-1.16, P = 0.13 (nominal); OS 18.6 vs. 16.2 months, HR 0.96, 95% CI 0.56-1.70, P = 0.9 (nominal)].","[{'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Nishimura', 'Affiliation': 'Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Kawakami', 'Affiliation': 'Saitama Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Joung', 'Affiliation': 'National Cancer Center, Goyang-si, South Korea.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Goto', 'Affiliation': 'Department of Urology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Tae Gyun', 'Initials': 'TG', 'LastName': 'Kwon', 'Affiliation': 'Chilgok Kyungpook National University Medical Center, Daegu, South Korea.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Urology, Kagawa University Hospital, Kagawa, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Department of Urology, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Shian-Shiang', 'Initials': 'SS', 'LastName': 'Wang', 'Affiliation': 'Division of Urology, Department of Surgery, Veterans General Hospital Taichung, Taichung, Taiwan.'}, {'ForeName': 'See-Tong', 'Initials': 'ST', 'LastName': 'Pang', 'Affiliation': 'Department of Uro-oncology, Chang Gung Medical Foundation-LinKou Branch, Taoyuan City, Taiwan.'}, {'ForeName': 'Chung-Hsin', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'AstraZeneca, Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nii', 'Affiliation': 'AstraZeneca, Osaka, Japan.'}, {'ForeName': 'Liji', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Dujka', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Division of Hematology-Oncology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'de Bono', 'Affiliation': 'Drug Development Unit, Institute of Cancer Research and Royal Marsden Hospital, London, UK.'}]",Japanese journal of clinical oncology,['10.1093/jjco/hyac015']
2782,34524700,Dosing Regimen Prediction and Confirmation With Rivaroxaban for Thromboprophylaxis in Children After the Fontan Procedure: Insights From the Phase III UNIVERSE Study.,"Thrombosis remains an important complication for children with single-ventricle physiology following the Fontan procedure, and effective thromboprophylaxis is an important unmet medical need. To obviate conventional dose-finding studies and expedite clinical development, a rivaroxaban dose regimen for this indication was determined using a model-informed drug development approach. A physiologically based pharmacokinetic rivaroxaban model was used to predict a pediatric dosing regimen that would produce drug exposures similar to that of 10 mg once daily in adults. This regimen was used in an open-label, multicenter phase III study, which investigated the use of rivaroxaban for thromboprophylaxis in post-Fontan patients 2 to 8 years of age. The pharmacokinetics (PK) of rivaroxaban was assessed in part A (n = 12) and in part B (n = 64) of the UNIVERSE study. The safety and efficacy in the rivaroxaban group were compared to those in the acetylsalicylic acid group for 12 months. Pharmacodynamic end points were assessed in both parts of the study. Rivaroxaban exposures achieved in parts A and B were similar to the adult reference exposures. Prothrombin time also showed similarity to the adult reference. Exposure-response analysis did not identify a quantitative relationship between rivaroxaban exposures and efficacy/safety outcomes within the observed exposure ranges. A body weight-based dose regimen selected by physiologically based pharmacokinetic modeling was shown in the UNIVERSE study to be appropriate for thromboprophylaxis in the post-Fontan pediatric population. Model-based dose selection can support pediatric drug development and bridge adult dose data to pediatrics, thereby obviating the need for dose-finding studies in pediatric programs.",2022,The safety and efficacy in the rivaroxaban group were compared to those in the acetylsalicylic acid group for 12 months.,"['post-Fontan patients 2 to 8 years of age', 'Children']","['acetylsalicylic acid', 'Rivaroxaban', 'rivaroxaban']","['safety and efficacy', 'Prothrombin time']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}]",,0.0404209,The safety and efficacy in the rivaroxaban group were compared to those in the acetylsalicylic acid group for 12 months.,"[{'ForeName': 'Peijuan', 'Initials': 'P', 'LastName': 'Zhu', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Willmann', 'Affiliation': 'Bayer AG, Pharmaceuticals, Research and Development, Wuppertal, Germany.'}, {'ForeName': 'Wangda', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey, USA.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Michelson', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'McCrindle', 'Affiliation': 'The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Harris', 'Affiliation': ""Children's Heart Centre, BC Children's Hospital, Vancouver, BC, Canada.""}, {'ForeName': 'Liza Miriam', 'Initials': 'LM', 'LastName': 'Pina', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Weber', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Nessel', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Lesko', 'Affiliation': 'University of Florida College of Pharmacy, Orlando, Florida, USA.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Kubitza', 'Affiliation': 'Bayer AG, Pharmaceuticals, Research and Development, Wuppertal, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zannikos', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1966']
2783,34806608,Caregiver Tele-Assistance for Reduction of Emotional Distress During the COVID-19 Pandemic. Psychological Support to Caregivers of People with Dementia: The Italian Experience.,"BACKGROUND


COVID-19 pandemic worsened vulnerability of patients with dementia (PWD). This new reality associated with government restriction and isolation worsened stress burden and psychological frailties in PWD caregivers.
OBJECTIVE


To give tele-psychological support to caregivers and evaluate the effect of this intervention by quantifying stress burden and quality of life during the first COVID-19 lockdown.
METHODS


50 caregivers were divided into two groups: ""Caregiver-focused group"" (Cg) and ""Patient-focused group"" (Pg). Both groups received telephone contact every 2 weeks over a 28-week period, but the content of the call was different: in Cg, caregivers answered questions about the state of the PWD but also explored their own emotional state, stress burden, and quality of life. In Pg instead, telephone contacts were focused only on the PWD, and no evaluation regarding the caregiver mood or state of stress was made. Psychometric scales were administered to evaluate COVID-19 impact, stress burden, and quality of life.
RESULTS


Considering the time of intervention, from baseline (W0) to W28, Zarit Burden Interview and Quality of Life-caregiver questionnaires remained unchanged in Cg as compared with baseline (p > 0.05), whereas they worsened significantly in Pg (p < 0.01), showing increased stress over time and decreased quality of life in this group. Moreover, Impact on Event Scale values improved over the weeks in Cg (p = 0.015), while they remained unchanged in Pg (p = 0.483).
CONCLUSION


Caregivers who received telephone support about their mood and stress burden did not worsen their psychological state during the time of intervention, as did instead those who did not get such support.",2022,"Moreover, Impact on Event Scale values improved over the weeks in Cg (p = 0.015), while they remained unchanged in Pg (p = 0.483).
","['patients with dementia (PWD', 'Caregivers of People with Dementia', '50 caregivers']","['Caregiver-focused group"" (Cg) and ""Patient-focused group"" (Pg', 'telephone contact']","['Emotional Distress', 'stress burden and quality of life', 'Psychometric scales', 'Event Scale values', 'COVID-19 impact, stress burden, and quality of life', 'caregiver mood or state of stress', 'stress over time and decreased quality of life', 'Zarit Burden Interview and Quality of Life-caregiver questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",50.0,0.0621382,"Moreover, Impact on Event Scale values improved over the weeks in Cg (p = 0.015), while they remained unchanged in Pg (p = 0.483).
","[{'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Rotondo', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Policlinico, Milan, Italy.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Galimberti', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Policlinico, Milan, Italy.""}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Mercurio', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Policlinico, Milan, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Giardinieri', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Policlinico, Milan, Italy.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Forti', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Policlinico, Milan, Italy.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Vimercati', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Policlinico, Milan, Italy.""}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Borracci', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Policlinico, Milan, Italy.""}, {'ForeName': 'Giorgio G', 'Initials': 'GG', 'LastName': 'Fumagalli', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Policlinico, Milan, Italy.""}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Pietroboni', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Policlinico, Milan, Italy.""}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Carandini', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Policlinico, Milan, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Nobili', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Scarpini', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Policlinico, Milan, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Arighi', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Policlinico, Milan, Italy.""}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-215185']
2784,35177194,Predictors of Left Main Coronary Artery Disease in the ISCHEMIA Trial.,"BACKGROUND


Detection of ≥50% diameter stenosis left main coronary artery disease (LMD) has prognostic and therapeutic implications. Noninvasive stress imaging or an exercise tolerance test (ETT) are the most common methods to detect obstructive coronary artery disease, though stress test markers of LMD remain ill-defined.
OBJECTIVES


The authors sought to identify markers of LMD as detected on coronary computed tomography angiography (CTA), using clinical and stress testing parameters.
METHODS


This was a post hoc analysis of ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches), including randomized and nonrandomized participants who had locally determined moderate or severe ischemia on nonimaging ETT, stress nuclear myocardial perfusion imaging, or stress echocardiography followed by CTA to exclude LMD. Stress tests were read by core laboratories. Prior coronary artery bypass grafting was an exclusion. In a stepped multivariate model, the authors identified predictors of LMD, first without and then with stress testing parameters.
RESULTS


Among 5,146 participants (mean age 63 years, 74% male), 414 (8%) had LMD. Predictors of LMD were older age (P < 0.001), male sex (P < 0.01), absence of prior myocardial infarction (P < 0.009), transient ischemic dilation of the left ventricle on stress echocardiography (P = 0.05), magnitude of ST-segment depression on ETT (P = 0.004), and peak metabolic equivalents achieved on ETT (P = 0.001). The models were weakly predictive of LMD (C-index 0.643 and 0.684).
CONCLUSIONS


In patients with moderate or severe ischemia, clinical and stress testing parameters were weakly predictive of LMD on CTA. For most patients with moderate or severe ischemia, anatomical imaging is needed to rule out LMD. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches [ISCHEMIA]; NCT01471522).",2022,"The models were weakly predictive of LMD (C-index 0.643 and 0.684).
","['participants who had locally determined moderate or severe ischemia on nonimaging ETT, stress nuclear myocardial perfusion imaging, or stress echocardiography followed by CTA to exclude LMD', '5,146 participants (mean age 63 years, 74% male), 414 (8%) had LMD']",['Noninvasive stress imaging or an exercise tolerance test (ETT'],"['absence of prior myocardial infarction', 'peak metabolic equivalents', 'transient ischemic dilation of the left ventricle on stress echocardiography', 'magnitude of ST-segment depression on ETT']","[{'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C2350390', 'cui_str': 'Myocardial Perfusion Imaging'}, {'cui': 'C0920208', 'cui_str': 'Stress echocardiogram'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1299433', 'cui_str': 'Left main coronary artery disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517771', 'cui_str': '414'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0225897', 'cui_str': 'Left cardiac ventricular structure'}, {'cui': 'C0920208', 'cui_str': 'Stress echocardiogram'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0520887', 'cui_str': 'ST segment depression'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]",5146.0,0.0314098,"The models were weakly predictive of LMD (C-index 0.643 and 0.684).
","[{'ForeName': 'Roxy', 'Initials': 'R', 'LastName': 'Senior', 'Affiliation': 'Northwick Park Hospital-Royal Brompton Hospital, London, United Kingdom. Electronic address: roxysenior@cardiac-research.org.'}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': 'New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Min', 'Affiliation': 'Cleerly, Inc, New York, New York, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Berman', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Picard', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': 'St Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St Louis, Missouri, USA.'}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': 'Cleerly, Inc, New York, New York, USA.'}, {'ForeName': 'Courtney B', 'Initials': 'CB', 'LastName': 'Page', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Sajeev C', 'Initials': 'SC', 'LastName': 'Govindan', 'Affiliation': 'Government Medical College, Calicut, India.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Sendon', 'Affiliation': 'Hospital Universitario La Paz, Idipaz, UAM, CIBER-CV, Madrid, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Peteiro', 'Affiliation': 'CHUAC, Universidad de A Coruña, CIBER-CV, A Coruna, Spain.'}, {'ForeName': 'Gurpreet S', 'Initials': 'GS', 'LastName': 'Wander', 'Affiliation': 'Dayanand Medical College & Hospital, Punjab, India.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Drozdz', 'Affiliation': 'Department Cardiology Medical University, Lodz, Poland.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Marin-Neto', 'Affiliation': 'Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Selvanayagam', 'Affiliation': 'Flinders Medical Centre, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': 'New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Thuaire', 'Affiliation': 'C.H. Louis Pasteur, Le Coudray, France.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Christopher', 'Affiliation': 'CARE Hospital, Hyderabad, India.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Jang', 'Affiliation': 'Kaiser Permanente/San Jose Medical Center, San Jose, California, USA.'}, {'ForeName': 'Raymond Y', 'Initials': 'RY', 'LastName': 'Kwong', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': 'New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': 'VA New England Healthcare System, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': 'New York University Grossman School of Medicine, New York, New York, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2021.11.052']
2785,35177200,Temporary Spinal Cord Stimulation to Prevent Postcardiac Surgery Atrial Fibrillation: 30-Day Safety and Efficacy Outcomes.,,2022,,['Postcardiac Surgery Atrial Fibrillation'],['Temporary Spinal Cord Stimulation'],['30-Day Safety and Efficacy Outcomes'],"[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.116438,,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Romanov', 'Affiliation': ''}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Lomivorotov', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Chernyavskiy', 'Affiliation': ''}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Murtazin', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Kliver', 'Affiliation': ''}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Ponomarev', 'Affiliation': ''}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Mikheenko', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Yakovlev', 'Affiliation': ''}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Yakovleva', 'Affiliation': ''}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Steinberg', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2021.08.078']
2786,33471564,Evaluation of the Effects of Intravitreal Aflibercept and Ranibizumab on Systemic Inflammatory and Cardiovascular Biomarkers in Patients with Neovascular Age-related Macular Degeneration.,"Purpose : To investigate the effects of intravitreal ranibizumab (IVR) and intravitreal aflibercept (IVA) on systemic inflammatory and cardiovascular biomarkers in treatment-naive patients with neovascular age-related macular degeneration (nAMD) Methods : This study included 24 eyes of 24 patients treated with 0.5 mg ranibizumab (IVR group) and 25 eyes of 25 patients treated with 2.0 mg aflibercept (IVA group). Complete blood count, C-reactive protein (CRP), low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), uric acid (UA), albumin, fibrinogen levels were measured in blood samples before and after the three-monthly loading dose treatment. Neutrophil/lymphocyte ratio (NLR), monocyte/HDL-c ratio (MHR), CRP/albumin ratio (CAR), monocyte/lymphocyte ratio (MLR), platelet/lymphocyte ratio (PLR) were also calculated. Results : A statistically significant decline was determined in post-treatment CRP ( P  = .002), LDL-c ( P  < .001) levels, white blood cell (WBC,  P  = .001), neutrophil ( P  < .001), monocyte ( P  = .019) counts and NLR ( P  = .020), MHR ( P  = .042), CAR ( P  = .010) ratios comparing with pre-treatment values in the IVA group. No statistically significant change was found in any of the parameters evaluated in the study in the IVR group. Also, there was no significant change in fibrinogen, lymphocyte count, MLR, HDL-c, UA, PLR, and platelet count values in both groups. Conclusion : Compared to IVR, IVA treatment had a small but significant effect on systemic inflammatory and cardiovascular biomarkers.",2021,"A statistically significant decline was determined in post-treatment CRP ( P  = .002), LDL-c ( P  < .001) levels, white blood cell (WBC,  ","['Patients with Neovascular Age-related Macular Degeneration', 'IVR group) and 25 eyes of 25 patients treated with 2.0 mg aflibercept (IVA group', 'treatment-naive patients with neovascular age-related macular degeneration (nAMD) Methods ', '24 eyes of 24 patients treated with 0.5 mg']","['ranibizumab', 'intravitreal ranibizumab (IVR) and intravitreal aflibercept (IVA', 'Intravitreal Aflibercept and Ranibizumab']","['white blood cell (WBC', 'Systemic Inflammatory and Cardiovascular Biomarkers', 'monocyte', 'LDL-c', 'neutrophil', 'fibrinogen, lymphocyte count, MLR, HDL-c, UA, PLR, and platelet count values', 'MHR ', 'Neutrophil/lymphocyte ratio (NLR), monocyte/HDL-c ratio (MHR), CRP/albumin ratio (CAR), monocyte/lymphocyte ratio (MLR), platelet/lymphocyte ratio (PLR', 'CAR', 'systemic inflammatory and cardiovascular biomarkers', 'Complete blood count, C-reactive protein (CRP), low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), uric acid (UA), albumin, fibrinogen levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen assay'}]",25.0,0.0372102,"A statistically significant decline was determined in post-treatment CRP ( P  = .002), LDL-c ( P  < .001) levels, white blood cell (WBC,  ","[{'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Erdem', 'Affiliation': 'Department of Ophthalmology, Ordu University Faculty of Medicine, Ordu, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Gok', 'Affiliation': 'Department of Ophthalmology, Private Atanur Eye Hospital, Isparta, Turkey.'}]",Current eye research,['10.1080/02713683.2021.1879868']
2787,34767985,Clinical performance of implantable cardioverter-defibrillator lead monitoring diagnostics.,"BACKGROUND


Implantable cardioverter-defibrillator (ICD) lead monitoring diagnostic alerts facilitate the diagnosis of structural lead failure.
OBJECTIVE


The purpose of this study was to prospectively study the performance of Medtronic ICD lead monitoring alerts.
METHODS


A prespecified ancillary substudy, World-Wide Randomized Antibiotic Envelope Infection Prevention Trial, was conducted in patients with an ICD with all available alerts enabled. The investigators reported possible lead system events (LSEs), with or without an alert. An independent committee reviewed all data and classified events as lead failure, other LSE, or nonlead system events (NLEs).
RESULTS


In 4942 patients who were followed for 19.4 ± 8.7 months, there were 124 alerts (65 LSEs, 59 NLEs) and 19 LSEs without an alert. Lead monitoring alerts had 100% sensitivity for the 48 adjudicated lead failures (95% confidence interval 92.6%-100%) and for 10 events adjudicated as either lead failure or connection issue. The positive predictive value of alerts for lead failure was 38.7% (48 of 124). For 34 pace-sense lead failures, an alert that incorporated oversensing was more sensitive than the pacing impedance threshold alert (33 patients [97.1%] vs 9 patients [26.5%]; P < .0001). However, the sensitivity was only 13.6% for lead dislodgments or perforations. Inappropriate shocks occurred in 2 patients with pace-sense lead failure (5.9%). No patient had unnecessary lead replacement for any of the NLEs.
CONCLUSION


In this first real-world prospective study, lead monitoring alerts had 100% sensitivity for identifying lead failures. Although their positive predictive value was modest, no false-positive alerts resulted in an unnecessary lead replacement. For the diagnosis of pace-sense lead failure, an alert for oversensing was more sensitive than a pacing impedance threshold alert.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02277990.",2022,"For 34 pace-sense lead failures, an alert that incorporated oversensing was more sensitive than the pacing impedance threshold alert (33 patients [97.1%] vs 9 patients [26.5%]; P < .0001).","['patients with an ICD with all available alerts enabled', '4942 patients who were followed for 19.4 ± 8.7 months, there were 124 alerts (65 LSEs, 59 NLEs) and 19 LSEs without an alert']","['Implantable cardioverter-defibrillator (ICD', 'implantable cardioverter-defibrillator lead monitoring diagnostics']",['sensitivity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4709305', 'cui_str': '19.4'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",4942.0,0.148579,"For 34 pace-sense lead failures, an alert that incorporated oversensing was more sensitive than the pacing impedance threshold alert (33 patients [97.1%] vs 9 patients [26.5%]; P < .0001).","[{'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'University of Washington School of Medicine, Seattle, Washington. Electronic address: jpoole@u.washington.edu.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Swerdlow', 'Affiliation': 'Cedars Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Khaldoun G', 'Initials': 'KG', 'LastName': 'Tarakji', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Valley Health System, Ridgewood, New Jersey.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Ellenbogen', 'Affiliation': 'VCU School of Medicine, Richmond, Virginia.'}, {'ForeName': 'Arnold J', 'Initials': 'AJ', 'LastName': 'Greenspon', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kennergren', 'Affiliation': 'Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Berit T', 'Initials': 'BT', 'LastName': 'Philbert', 'Affiliation': 'Department of Cardiology, the Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'JoEllyn', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota.'}, {'ForeName': 'R Chris', 'Initials': 'RC', 'LastName': 'Jones', 'Affiliation': 'Centennial Heart, Nashville, Tennessee.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Schaller', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Riple', 'Initials': 'R', 'LastName': 'Hansalia', 'Affiliation': 'Jersey Shore University Medical Center, Neptune, New Jersey.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Simmers', 'Affiliation': 'Catharina Ziekenhuis, Eindhoven, The Netherlands.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Mihalcz', 'Affiliation': 'Universitätsklinikum Krems, Krems, Austria.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'DeBus', 'Affiliation': 'Medtronic, Mounds View, Minnesota.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Lexcen', 'Affiliation': 'Medtronic, Mounds View, Minnesota.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Gunderson', 'Affiliation': 'Medtronic, Mounds View, Minnesota.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Wilkoff', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}]",Heart rhythm,['10.1016/j.hrthm.2021.10.032']
2788,35166788,Evaluation of Online Patient Portal vs Text-Based Blood Pressure Monitoring Among Black Patients With Medicaid and Medicare Insurance Who Have Hypertension and Cardiovascular Disease.,,2022,,['Black Patients With Medicaid and Medicare Insurance'],['Online Patient Portal vs Text-Based Blood Pressure Monitoring'],[],"[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}]","[{'cui': 'C4277550', 'cui_str': 'Patient Portal'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}]",[],,0.0391968,,"[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Eberly', 'Affiliation': 'Division of Cardiovascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Sanghavi', 'Affiliation': 'Division of Cardiovascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Julien', 'Affiliation': 'Division of Cardiovascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Burger', 'Affiliation': 'Division of Cardiovascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Neel', 'Initials': 'N', 'LastName': 'Chokshi', 'Affiliation': 'Division of Cardiovascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lewey', 'Affiliation': 'Division of Cardiovascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.44255']
2789,35226566,Associations between circulating microRNAs and coronary plaque characteristics: potential impact from physical exercise.,"Background and aims MicroRNAs (miRs) are involved in different steps in the development of atherosclerosis and are proposed as promising biomarkers of coronary artery disease (CAD). We hypothesized that circulating levels of miRs were associated with coronary plaque components assessed by radiofrequency intravascular ultrasound (RF-IVUS) before and after aerobic exercise intervention. Methods 31 patients with CAD treated with percutaneous coronary intervention (PCI) previously included in a randomized trial with aerobic interval training (AIT) or moderate continuous training (MCT) as post-PCI intervention were included. Coronary plaque characteristics by grayscale and RF-IVUS and predefined circulating candidate miRs in plasma were analysed at baseline and follow-up. Associations between miRs and coronary plaque composition, and the potential effect from exercise, were analysed using linear regression. Results Circulating levels of miR-15a-5p, miR-30e-5p, miR-92a-3p, miR-199a-3p, miR-221-3p, and miR-222-3p were associated with baseline coronary necrotic core volume. Following exercise intervention, decreased levels of miR-15a-5p, miR-93-5p, and miR-451a, and increased levels of miR-146a-5p were associated with an observed regression of coronary plaque burden. A mirPath prediction tool identified that genes regulated by miR-15a-5p, miR-199a-3p, and miR-30e-5p were significantly overrepresented in pathways related to fatty acid biosynthesis and fatty acid metabolism. Conclusion This exploratory study demonstrated six miRs associated with coronary necrotic core, a marker of plaque vulnerability. In addition, changes in four miRs were associated with a regression of coronary plaque burden following exercise intervention. These novel findings may identify potential future biomarkers of CAD and coronary plaque composition.",2022,"Following exercise intervention, decreased levels of miR-15a-5p, miR-93-5p, and miR-451a, and increased levels of miR-146a-5p were associated with an observed regression of coronary plaque burden.",['31 patients with CAD treated with'],"['aerobic interval training (AIT) or moderate continuous training (MCT', 'percutaneous coronary intervention (PCI']","['levels of miR-15a-5p, miR-93-5p, and miR-451a, and increased levels of miR-146a-5p']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",31.0,0.0305803,"Following exercise intervention, decreased levels of miR-15a-5p, miR-93-5p, and miR-451a, and increased levels of miR-146a-5p were associated with an observed regression of coronary plaque burden.","[{'ForeName': 'Maria Dalen', 'Initials': 'MD', 'LastName': 'Taraldsen', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Wiseth', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Videm', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Bye', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Madssen', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}]",Physiological genomics,['10.1152/physiolgenomics.00071.2021']
2790,35226559,Efficacy and Safety of Edoxaban 15 mg According to Renal Function in Very Elderly Patients With Atrial Fibrillation: A Subanalysis of the ELDERCARE-AF Trial.,,2022,,['Very Elderly Patients With Atrial Fibrillation'],['Edoxaban'],['Efficacy and Safety'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0287843,,"[{'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Department of Cardiovascular Medicine, Onga Nakama Medical Association Onga Hospital, Japan (T. Yoshida).'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Cardiology, Iwate Prefectural Central Hospital, Morioka, Japan (A.N.).'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Funada', 'Affiliation': 'Department of Cardiology, National Hospital Organization Ehime Medical Center, Toon, Japan (J.F.).'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Amino', 'Affiliation': 'Department of Cardiology, Tokai University, Isehara, Japan (M.A.).'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Shimizu', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan (W.S.).'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Fukuzawa', 'Affiliation': 'Cardiovascular Group, Primary Medical Science Department, Japan Business Unit (M.F.), Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Saori', 'Initials': 'S', 'LastName': 'Watanabe', 'Affiliation': 'Clinical Development Department III, Development Function, Research and Development Division (S.W.), Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'The Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division (T.H.), Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan (T. Yamashita).'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Okumura', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto, Japan (K.O.).'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Akao', 'Affiliation': 'Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan (M.A.).'}]",Circulation,['10.1161/CIRCULATIONAHA.121.057190']
2791,35226538,Increasing Student Confidence With Medically Complex Infants Through Simulation: A Mixed Methods Investigation.,"PURPOSE


The purpose of this study was to compare student knowledge and confidence, related to the assessment and management of oral feeding readiness in medically complex infants, following a written case study versus a high-fidelity human patient simulation (HPS).
METHOD


A sequential, two-phase, embedded mixed methods design was conducted. Participants were two sequential cohorts of second-year speech-language pathology graduate students enrolled in a didactic Pediatric Dysphagia course. At the end of the course, students completed the same case scenario presented as a written case study (control group;  N  = 28) or as an HPS (experimental group;  N  = 24). Pre- and post-knowledge assessment results and self-assessments of confidence conducted at three time points were compared.
RESULTS


All students made gains in knowledge, regardless of intervention (written case study or HPS). Despite different baselines, the percent change in knowledge was significant with the control group improving 33% and the experimental group improving 76% from baseline. Students in the experimental group demonstrated significantly greater gains in confidence with skills enhanced by the hands-on, immersive experience of HPS. Qualitative analysis further identified factors contributing to increased confidence with all students reporting that experience significantly contributes to their confidence in their ability to treat patients.
CONCLUSIONS


While knowledge outcomes were similar between the groups, the confidence that the experimental group gained through the hands-on experiences of HPS fosters student development as confident professionals in assessing feeding readiness and managing medically complex infants. Results support integration of simulation into the graduate curriculum to support student learning.
SUPPLEMENTAL MATERIAL


https://doi.org/10.23641/asha.19233504.",2022,"Students in the experimental group demonstrated significantly greater gains in confidence with skills enhanced by the hands-on, immersive experience of HPS.","['medically complex infants, following a written case study versus a high-fidelity human patient simulation (HPS', 'Participants were two sequential cohorts of second-year speech-language pathology graduate students enrolled in a didactic Pediatric Dysphagia course']",[],"['gains in confidence with skills enhanced by the hands-on, immersive experience of HPS']","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0085973', 'cui_str': 'Case Studies'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0085137', 'cui_str': 'Patient Simulation'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037825', 'cui_str': 'Pathology, Speech-Language'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]",[],"[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0085137', 'cui_str': 'Patient Simulation'}]",,0.0395365,"Students in the experimental group demonstrated significantly greater gains in confidence with skills enhanced by the hands-on, immersive experience of HPS.","[{'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Clinard', 'Affiliation': 'Department of Communication Sciences and Disorders, James Madison University, Harrisonburg, VA.'}]",American journal of speech-language pathology,['10.1044/2021_AJSLP-21-00234']
2792,35226532,DAPT de-escalation from ticagrelor to clopidogrel 1 mo after PCI for acute MI reduced net clinical events at 1 y.,"SOURCE CITATION


Kim CJ, Park MW, Kim MC, et al.  Unguided de-escalation from ticagrelor to clopidogrel in stabilised patients with acute myocardial infarction undergoing percutaneous coronary intervention (TALOS-AMI): an investigator-initiated, open-label, multicentre, non-inferiority, randomised trial.  Lancet. 2021;398:1305-16. 34627490.",2022,"Unguided de-escalation from ticagrelor to clopidogrel in stabilised patients with acute myocardial infarction undergoing percutaneous coronary intervention (TALOS-AMI): an investigator-initiated, open-label, multicentre, non-inferiority, randomised trial.  ",['stabilised patients with acute myocardial infarction undergoing percutaneous coronary intervention (TALOS-AMI'],['ticagrelor to clopidogrel'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]",[],,0.113815,"Unguided de-escalation from ticagrelor to clopidogrel in stabilised patients with acute myocardial infarction undergoing percutaneous coronary intervention (TALOS-AMI): an investigator-initiated, open-label, multicentre, non-inferiority, randomised trial.  ","[{'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Bach', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri, USA (R.G.B.).'}]",Annals of internal medicine,['10.7326/J22-0002']
2793,35226531,"In COVID-19 with hypoxemia, 12 vs. 6 mg/d of dexamethasone did not increase days alive without life support.","SOURCE CITATION


Munch MW, Myatra SN, Vijayaraghavan BK, et al.  Effect of 12 mg vs 6 mg of dexamethasone on the number of days alive without life support in adults with COVID-19 and severe hypoxemia: the COVID STEROID 2 randomized trial.  JAMA. 2021;326:1807-17. 34673895.",2022,Effect of 12 mg vs 6 mg of dexamethasone on the number of days alive without life support in adults with COVID-19 and severe hypoxemia: the COVID STEROID 2 randomized trial.  ,['adults with COVID-19 and severe hypoxemia'],['dexamethasone'],['number of days alive without life support'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}]",,0.0779665,Effect of 12 mg vs 6 mg of dexamethasone on the number of days alive without life support in adults with COVID-19 and severe hypoxemia: the COVID STEROID 2 randomized trial.  ,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Jacka', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada (M.J.J.).'}]",Annals of internal medicine,['10.7326/J22-0001']
2794,35226527,"In patients with MI or high-risk coronary disease, influenza vaccination reduced CV events at 12 mo.","SOURCE CITATION


Fröbert O, Götberg M, Erlinge D, et al.  Influenza vaccination after myocardial infarction: a randomized, double-blind, placebo-controlled, multicenter trial.  Circulation. 2021;144:1476-84. 34459211.",2022,"Influenza vaccination after myocardial infarction: a randomized, double-blind, placebo-controlled, multicenter trial.  ",['after myocardial infarction'],"['Influenza vaccination', 'placebo']",['CV events'],"[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}]",,0.469553,"Influenza vaccination after myocardial infarction: a randomized, double-blind, placebo-controlled, multicenter trial.  ","[{'ForeName': 'Edwin Grajeda', 'Initials': 'EG', 'LastName': 'Silvestri', 'Affiliation': 'University of Miami Miller School of Medicine, Palm Beach Campus, Atlantis, Florida, USA (E.G.S., S.B.).'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Borzak', 'Affiliation': 'University of Miami Miller School of Medicine, Palm Beach Campus, Atlantis, Florida, USA (E.G.S., S.B.).'}]",Annals of internal medicine,['10.7326/J22-0006']
2795,35226526,Prophylactic scopolamine butylbromide reduced death rattle in patients in the dying phase.,"SOURCE CITATION


van Esch HJ, van Zuylen L, Geijteman ECT, et al.  Effect of prophylactic subcutaneous scopolamine butylbromide on death rattle in patients at the end of life: the SILENCE randomized clinical trial.  JAMA. 2021;326:1268-76. 34609452.",2022,Effect of prophylactic subcutaneous scopolamine butylbromide on death rattle in patients at the end of life,"['patients in the dying phase', 'patients at the end of life']","['Prophylactic scopolamine butylbromide', 'prophylactic subcutaneous scopolamine butylbromide']",['death rattle'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0006519', 'cui_str': 'Scopolamine butylbromide'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0547002', 'cui_str': 'Death rattle'}]",,0.196408,Effect of prophylactic subcutaneous scopolamine butylbromide on death rattle in patients at the end of life,"[{'ForeName': 'Ashesha', 'Initials': 'A', 'LastName': 'Mechineni', 'Affiliation': 'University of Illinois Chicago, Chicago, Illinois, USA (A.M.).'}]",Annals of internal medicine,['10.7326/J22-0005']
2796,35226737,"General Anesthesia versus Sedation, Both with Hemodynamic Control, during Intraarterial Treatment for Stroke: The GASS Randomized Trial.","BACKGROUND


It is speculated that the anesthetic strategy during endovascular therapy for stroke may have an impact on the outcome of the patients. The authors hypothesized that conscious sedation is associated with a better functional outcome 3 months after endovascular therapy for the treatment of stroke compared with general anesthesia.
METHODS


In this single-blind, randomized trial, patients received either a standardized general anesthesia or a standardized conscious sedation. Blood pressure control was also standardized in both groups. The primary outcome measure was a modified Rankin score less than or equal to 2 (0 = no symptoms; 5 = severe disability) assessed 3 months after treatment. The main secondary outcomes were complications, mortality, reperfusion results, and National Institutes of Health Stroke Scores at days 1 and 7.
RESULTS


Of 351 randomized patients, 345 were included in the analysis. The primary outcome occurred in 129 of 341 (38%) of the patients: 63 (36%) in the conscious sedation group and 66 (40%) in the general anesthesia group (relative risk, 0.91 [95% CI, 0.69 to 1.19]; P = 0.474). Patients in the general anesthesia group experienced more intraoperative hypo- or hypertensive episodes, while the cumulative duration was not different (mean ± SD, 36 ± 31 vs. 39 ± 25 min; P = 0.079). The time from onset and from arrival to puncture were longer in the general anesthesia group (mean difference, 19 min [i.e., -00:19] [95% CI, -0:38 to 0] and mean difference, 9 min [95% CI, -0:18 to -0:01], respectively), while the time from onset to recanalization was similar in both groups. Recanalization was more often successful in the general anesthesia group (144 of 169 [85%] vs. 131 of 174 [75%]; P = 0.021). The incidence of symptomatic intracranial hemorrhage was similar in both groups.
CONCLUSIONS


The functional outcomes 3 months after endovascular treatment for stroke were similar with general anesthesia and sedation. Our results, therefore, suggest that clinicians can use either approach.
EDITOR’S PERSPECTIVE


",2022,Recanalization was more often successful in the general anesthesia group (144 of 169 [85%] vs. 131 of 174 [75%]; P = 0.021).,"['Of 351 randomized patients, 345 were included in the analysis', 'Stroke']","['General Anesthesia versus Sedation, Both with Hemodynamic Control', 'standardized general anesthesia or a standardized conscious sedation']","['Recanalization', 'cumulative duration', 'modified Rankin score less than or equal to 2 (0 = no symptoms; 5 = severe disability', 'Blood pressure control', 'time from onset and from arrival to puncture', 'time from onset to recanalization', 'symptomatic intracranial hemorrhage', 'intraoperative hypo- or hypertensive episodes', 'complications, mortality, reperfusion results, and National Institutes of Health Stroke Scores at days 1 and 7']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}]","[{'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3888574', 'cui_str': 'Modified Rankin score'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0520539', 'cui_str': 'Hypertensive episode'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",351.0,0.245011,Recanalization was more often successful in the general anesthesia group (144 of 169 [85%] vs. 131 of 174 [75%]; P = 0.021).,"[{'ForeName': 'Axelle', 'Initials': 'A', 'LastName': 'Maurice', 'Affiliation': ''}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Eugène', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ronzière', 'Affiliation': ''}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Devys', 'Affiliation': ''}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Subileau', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Huet', 'Affiliation': ''}, {'ForeName': 'Hakim', 'Initials': 'H', 'LastName': 'Gherbi', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Laffon', 'Affiliation': ''}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Esvan', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Laviolle', 'Affiliation': ''}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Beloeil', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000004142']
2797,35226723,"A randomized, placebo-controlled, double-blind trial of canakinumab in children and young adults with sickle cell anemia.","Excessive intravascular release of lysed cellular contents from damaged red blood cells (RBCs) in patients with sickle cell anemia (SCA) can activate the inflammasome, a multiprotein oligomer promoting maturation and secretion of pro-inflammatory cytokines, including interleukin 1-beta (IL-1b). We hypothesized that IL-1b blockade by canakinumab in patients with SCA would reduce markers of inflammation and clinical disease activity. In this randomized, double-blind, multi-center phase 2a study, patients aged 8-20 years old with SCA (HbSS or HbSb0thalassemia), history of acute pain episodes and elevated hsCRP >1.0 mg/L at screening were randomized 1:1 to received 6 monthly treatments with 300 mg s.c. canakinumab or placebo. Measured outcomes at baseline and weeks 4, 8, 12, 16, 20 and 24 included electronic patient-reported outcomes, hospitalization rate and adverse events (AEs) and serious AEs (SAEs). All but one of the 49 enrolled patients were receiving stable background hydroxyurea therapy. Although the primary objective (pre-specified reduction of pain) was not met, compared to placebo-arm patients, canakinumab-treated patients had reductions in markers of inflammation, occurrence of SCA-related AE and SAE, and number and duration of hospitalizations, as well as trends for improvement in pain intensity, fatigue and absences from school or work. Post-hoc analysis revealed treatment effects on weight, restricted to pediatric patients. Canakinumab was well tolerated with no treatment-related SAEs and no new safety signal. These findings demonstrate that the inflammation associated with SCA can be reduced by selective IL-1b blockade by canakinumab with potential for therapeutic benefits. This trial was registered at www.clinicaltrials.gov as NCT02961218.",2022,Canakinumab was well tolerated with no treatment-related SAEs and no new safety signal.,"['49 enrolled patients were receiving stable background hydroxyurea therapy', 'patients with sickle cell anemia (SCA', 'patients aged 8-20 years old with SCA (HbSS or HbSb0thalassemia), history of acute pain episodes and elevated hsCRP >1.0 mg/L at screening', 'children and young adults with sickle cell anemia', 'patients with SCA']","['damaged red blood cells (RBCs', 'canakinumab', 'canakinumab or placebo', 'placebo']","['markers of inflammation, occurrence of SCA-related AE and SAE, and number and duration of hospitalizations', 'pain', 'pain intensity, fatigue and absences', 'hospitalization rate and adverse events (AEs) and serious AEs (SAEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",49.0,0.745177,Canakinumab was well tolerated with no treatment-related SAEs and no new safety signal.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Rees', 'Affiliation': ""King's College London, King's College Hospital, London, United Kingdom.""}, {'ForeName': 'Yurdanur', 'Initials': 'Y', 'LastName': 'Kilinc', 'Affiliation': 'Cukurova University Medical Facility, Adana, Turkey.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Unal', 'Affiliation': 'Mersin University Medical Faculty, Mercin, Turkey.'}, {'ForeName': 'Carlton D', 'Initials': 'CD', 'LastName': 'Dampier', 'Affiliation': 'Emory University, Atlanta, Georgia, United States.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Pace', 'Affiliation': 'Augusta University, Cancer Ctr, Augusta, Georgia, United States.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Kaya', 'Affiliation': ""Bart's Health NHS Trust, London, United Kingdom.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Trompeter', 'Affiliation': 'University College London Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Odame', 'Affiliation': 'The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Mahlangu', 'Affiliation': 'University of the Witwatersrand & NHLS, Johannesburg, South Africa.'}, {'ForeName': 'Sule', 'Initials': 'S', 'LastName': 'Unal', 'Affiliation': 'Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brent', 'Affiliation': 'Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Grosse', 'Affiliation': 'Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Beng', 'Initials': 'B', 'LastName': 'Fuh', 'Affiliation': 'East Carolina University, Greenville, North Carolina, United States.'}, {'ForeName': 'Baba Pd', 'Initials': 'BP', 'LastName': 'Inusa', 'Affiliation': ""Guy's and St Thomas' Hospital, London, Wyoming, United Kingdom.""}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Koren', 'Affiliation': 'Emek Medical Center, Afula, Israel.'}, {'ForeName': 'Goksel', 'Initials': 'G', 'LastName': 'Leblebisatan', 'Affiliation': 'Cukurova University Medical Faculty, Adana, Turkey, Adana, Turkey.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Levin', 'Affiliation': 'Emek Medical Center, Afula, Israel.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McNamara', 'Affiliation': 'Novartis Pharma AG, Cambridge, Massachusetts, United States.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Meiser', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hom', 'Affiliation': 'Novartis Pharma AG, Cambridge, Massachusetts, United States.'}, {'ForeName': 'Stephen John', 'Initials': 'SJ', 'LastName': 'Oliver', 'Affiliation': 'Novartis Institute for BioMedical Research, Basel, Switzerland.'}]",Blood,['10.1182/blood.2021013674']
2798,35226728,The Effect of Radiotherapy on the Marginal Adaptation of Class II Direct Resin Composite Restorations: A Micro-computed Tomography Analysis.,"This laboratory study was designed to evaluate the marginal adaptation of Class II mesio-occluso-distal (MOD) restorations at the cervical region with micro-computed tomography (micro-CT). Two groups of restorations were compared: 1) those that had been exposed to radiotherapy before restoration was performed using a universal adhesive in etch-and-rinse and self-etch modes; and 2) those that had previously been restored using a universal adhesive in etch-and-rinse and self-etch modes and had subsequently undergone radiotherapy. Sixty intact human molars were randomly divided into groups according to irradiation status: no radiotherapy (control group); radiotherapy followed by restoration (radiotherapy-first group); and restoration followed by radiotherapy (restoration-first group). These three groups were then subdivided into two groups each on the basis of adhesive application type (etch-and-rinse and self-etch modes), for a total of six groups (n=10/group). Standardized Class II MOD cavities were prepared. A universal adhesive (Clearfil Universal Bond Quick, Kuraray, Okayama, Japan) was applied. The teeth were restored with resin composite (Estelite Posterior Quick, Tokuyama, Tokyo, Japan). The radiotherapy protocol was conducted with 60 gray (Gy) at 2 Gy/day, five days a week for six weeks. Adhesive defects were analyzed in distal and mesial views and evaluated with micro-CT (SkyScan 1174v2, Kontich, Antwerp, Belgium) on the basis of the volume of black spaces between the cavity walls and the restorative materials (mm3). The data were analyzed using the Kruskal-Wallis, Mann Whitney U and Wilcoxon tests (p<0.05). The radiotherapy protocol did not affect the marginal adaptation of the universal adhesive at the cervical regions. Regarding the application modes, for the radiotherapy-first group, the self-etch mode caused significantly higher adhesive defects than the etch-and-rinse mode at the dentin margin. For the no-radiotherapy group, the adhesive defects at the dentin margin were significantly higher than at the enamel margin with the application of the etch-and-rinse mode.",2022,"Regarding the application modes, for the radiotherapy-first group, the self-etch mode caused significantly higher adhesive defects than the etch-and-rinse mode at the dentin margin.","['Class II Direct Resin Composite Restorations', 'Sixty intact human molars']","['universal adhesive in etch-and-rinse and self-etch modes and had subsequently undergone radiotherapy', 'Radiotherapy', 'no radiotherapy (control group); radiotherapy followed by restoration (radiotherapy-first group); and restoration followed by radiotherapy (restoration-first group', 'micro-computed tomography (micro-CT']","['adhesive defects', 'marginal adaptation of Class II mesio-occluso-distal (MOD) restorations']","[{'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C2350281', 'cui_str': 'MicroCT'}]","[{'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]",,0.0168427,"Regarding the application modes, for the radiotherapy-first group, the self-etch mode caused significantly higher adhesive defects than the etch-and-rinse mode at the dentin margin.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Oglakci', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Burduroğlu', 'Affiliation': ''}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Eriş', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mayadağlı', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Arhun', 'Affiliation': ''}]",Operative dentistry,['10.2341/20-066-L']
2799,35226725,Prophylactic Penehyclidine Inhalation for Prevention of Postoperative Pulmonary Complications in High-risk Patients: A Double-blind Randomized Trial.,"BACKGROUND


Postoperative pulmonary complications are common. Aging and respiratory disease provoke airway hyperresponsiveness, high-risk surgery induces diaphragmatic dysfunction, and general anesthesia contributes to atelectasis and peripheral airway injury. This study therefore tested the hypothesis that inhalation of penehyclidine, a long-acting muscarinic antagonist, reduces the incidence of pulmonary complications in high-risk patients over the initial 30 postoperative days.
METHODS


This single-center double-blind trial enrolled 864 patients age over 50 yr who were scheduled for major upper-abdominal or noncardiac thoracic surgery lasting 2 h or more and who had an Assess Respiratory Risk in Surgical Patients in Catalonia score of 45 or higher. The patients were randomly assigned to placebo or prophylactic penehyclidine inhalation from the night before surgery through postoperative day 2 at 12-h intervals. The primary outcome was the incidence of a composite of pulmonary complications within 30 postoperative days, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis.
RESULTS


A total of 826 patients (mean age, 64 yr; 63% male) were included in the intention-to-treat analysis. A composite of pulmonary complications was less common in patients assigned to penehyclidine (18.9% [79 of 417]) than those receiving the placebo (26.4% [108 of 409]; relative risk, 0.72; 95% CI, 0.56 to 0.93; P = 0.010; number needed to treat, 13). Bronchospasm was less common in penehyclidine than placebo patients: 1.4% (6 of 417) versus 4.4% (18 of 409; relative risk, 0.327; 95% CI, 0.131 to 0.82; P = 0.011). None of the other individual pulmonary complications differed significantly. Peak airway pressures greater than 40 cm H2O were also less common in patients given penehyclidine: 1.9% (8 of 432) versus 4.9% (21 of 432; relative risk, 0.381; 95% CI, 0.171 to 0.85; P = 0.014). The incidence of other adverse events, including dry mouth and delirium, that were potentially related to penehyclidine inhalation did not differ between the groups.
CONCLUSIONS


In high-risk patients having major upper-abdominal or noncardiac thoracic surgery, prophylactic penehyclidine inhalation reduced the incidence of pulmonary complications without provoking complications.
EDITOR’S PERSPECTIVE


",2022,"The incidence of other adverse events, including dry mouth and delirium, that were potentially related to penehyclidine inhalation did not differ between the groups.
","['High-risk Patients', '826 patients (mean age, 64 yr; 63% male', '864 patients age over 50 yr who were scheduled for major upper-abdominal or noncardiac thoracic surgery lasting 2 h or more and who had an Assess Respiratory Risk in Surgical Patients in Catalonia score of 45 or higher', 'high-risk patients over the initial 30 postoperative days']","['penehyclidine', 'placebo', 'Prophylactic Penehyclidine Inhalation', 'prophylactic penehyclidine inhalation', 'placebo or prophylactic penehyclidine inhalation']","['incidence of other adverse events, including dry mouth and delirium', 'pulmonary complications', 'Postoperative Pulmonary Complications', 'incidence of a composite of pulmonary complications within 30 postoperative days, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis', 'Peak airway pressures', 'Bronchospasm']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1451872', 'cui_str': 'penehyclidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]",864.0,0.670681,"The incidence of other adverse events, including dry mouth and delirium, that were potentially related to penehyclidine inhalation did not differ between the groups.
","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Xin-Quan', 'Initials': 'XQ', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Guo-Jun', 'Initials': 'GJ', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Wei-Ou', 'Initials': 'WO', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Liang-Yu', 'Initials': 'LY', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Kun-Yao', 'Initials': 'KY', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Sai-Nan', 'Initials': 'SN', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Dong-Xin', 'Initials': 'DX', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000004159']
2800,35229694,The efficacy and safety profile of cataract procedures performed with a sensor-embedded handpiece and a new hybrid phaco tip.,"OBJECTIVE


To evaluate the efficacy and safety of the new Intrepid Hybrid tip and Active Sentry handpiece in comparison to the Intrepid Balanced tip and Centurion Ozil handpiece.
METHODS


One hundred sixty-eight eyes were included in the study and randomized into Group 1 (Active Sentry handpiece + Intrepid Hybrid tip, n = 86) and Group 2 (Centurion Ozil handpiece + Intrepid Balanced tip, n = 82). Data were collected from the phaco device, including total U/S time, cumulative dissipated energy (CDE), the total number of active surge mitigation actuations (ASM actuations), torsional amplitude, torsional amplitude on time, estimated fluid of aspirated, and aspiration time. Endothelial cell count (ECC) and central corneal thickness (CCT) were assessed. A correlation analysis was performed between ASM actuations, phaco metrics, and patient characteristics in Group 1.
RESULTS


The CDE, torsional amplitude measured in Group 1 (8.8 ± 3.9, 51.2 ± 13.3, respectively) were significantly lower than those of Group 2 (10.4 ± 4.2, 65.2 ± 9.3, respectively). While no complications were observed in group 1, there were posterior capsule rupture in 2 eyes and iris damage in 1 eye in group 2. The mean ECC and CCT were similar at 1 month. The ASM actuations were more engaged in the eyes with pseudoexfoliation and small pupils.
CONCLUSION


The combination of the new Intrepid Hybrid tip and Active Sentry handpiece enables safer cataract procedures without compromising efficacy due to its surge prevention mechanisms and special tip design. It could be a good option for residents in training.",2022,"While no complications were observed in group 1, there were posterior capsule rupture in 2 eyes and iris damage in 1 eye in group 2.",['One hundred sixty-eight eyes'],"['Group 1 (Active Sentry handpiece\u2009+\u2009Intrepid Hybrid tip, n\u2009=\u200986) and Group 2 (Centurion Ozil handpiece\u2009+\u2009Intrepid Balanced tip, n\u2009=\u200982', 'new Intrepid Hybrid tip and Active Sentry handpiece', 'sensor-embedded handpiece and a new hybrid phaco tip']","['mean ECC and CCT', 'CDE, torsional amplitude', 'total U/S time, cumulative dissipated energy (CDE), the total number of active surge mitigation actuations (ASM actuations), torsional amplitude, torsional amplitude on time, estimated fluid of aspirated, and aspiration time', 'Endothelial cell count (ECC) and central corneal thickness (CCT', 'efficacy and safety', 'posterior capsule rupture']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0181115', 'cui_str': 'Handpiece'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0450425', 'cui_str': 'Torsional'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4319628', 'cui_str': 'Actuation'}, {'cui': 'C0242536', 'cui_str': 'Eastern Samoa'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0370199', 'cui_str': 'Specimen obtained by aspiration'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1535895', 'cui_str': 'Posterior capsule rupture'}]",168.0,0.0709589,"While no complications were observed in group 1, there were posterior capsule rupture in 2 eyes and iris damage in 1 eye in group 2.","[{'ForeName': 'Huri', 'Initials': 'H', 'LastName': 'Sabur', 'Affiliation': 'Department of Ophthalmology, Izzet Baysal State Hospital, Bolu, Turkey.'}, {'ForeName': 'Ugur', 'Initials': 'U', 'LastName': 'Unsal', 'Affiliation': 'Department of Ophthalmology, Batigoz Eye Health Center, Izmir, Turkey.'}]",European journal of ophthalmology,['10.1177/11206721221084764']
2801,35229692,Double safe suture during cataract surgery on post radial keratotomy patients using clear corneal incisions.,"PURPOSE


the aim of this study is to find a safer surgical approach in cataract surgery on eyes previously treated with radial keratotomy using clear corneal incisions.
SETTING


Department of Biomedical and Dental Sciences and Morphofunctional Imaging, Ophthalmology Clinic, University of Messina, Messina, Italy.
DESIGN


Prospective study.
METHODS


A prospective study was conducted on a group of 20 patients, 21 eyes with 16 RK incisions were evaluated for cataract phacoemulsification. Samples were divided into two groups: Group 1 underwent surgery with pre-operative one corneal stitch along radial keratotomy incisions near the main access site whereas Group 2 underwent modified surgery with two corneal stitches.
RESULTS


After surgery, visual acuity, corneal hysteresis and corneal strength was evaluated. In all cases, an increased visual acuity was observed. Group 1 showed an UCVA of logMAR 0.22 ± 0.14, while group 2 presented a logMAR of 0.1 ± 0.07. Data did not show a statistically significant difference in UCVA after surgery between the two groups ( P  = 0.133). Instead, a significant difference in corneal hysteresis (CH), respectively with values of 8.65 ± 1.6 mmHg in group 1 and 9.2 ± 1.8 in group 2 ( P  = 0.031), and a corneal resistance factor (CRF) with values of 7.87 ± 1.4 mmHg in the first group and 8.65 ± 1.6 mmHg in the second one ( P  = 0.039) was observed.
CONCLUSIONS


Double safe suture technique offers better stabilization of corneal structure during surgery in patients preventively treated with 16 incisions RK.",2022,Data did not show a statistically significant difference in UCVA after surgery between the two groups ( P  = 0.133).,"['20 patients, 21 eyes with 16 RK incisions', 'patients preventively treated with 16 incisions RK', 'post radial keratotomy patients using clear corneal incisions', 'Department of Biomedical and Dental Sciences and Morphofunctional Imaging, Ophthalmology Clinic, University of Messina, Messina, Italy']","['radial keratotomy', 'cataract phacoemulsification', 'surgery with pre-operative one corneal stitch along radial keratotomy incisions near the main access site whereas Group 2 underwent modified surgery with two corneal stitches', 'Double safe suture during cataract surgery']","['corneal resistance factor (CRF', 'corneal structure', 'visual acuity, corneal hysteresis and corneal strength', 'corneal hysteresis (CH', 'UCVA', 'visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0022607', 'cui_str': 'Radial keratotomy'}, {'cui': 'C1827493', 'cui_str': 'Clear corneal incision'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C3838844', 'cui_str': 'Ophthalmology clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0022607', 'cui_str': 'Radial keratotomy'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0034471', 'cui_str': 'R factor'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}]",21.0,0.0308889,Data did not show a statistically significant difference in UCVA after surgery between the two groups ( P  = 0.133).,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Meduri', 'Affiliation': 'Department of Biomedical and Dental Sciences and Morphofunctional Imaging, Ophthalmology Clinic, 18980University of Messina, Messina, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Oliverio', 'Affiliation': 'Department of Biomedical and Dental Sciences and Morphofunctional Imaging, Ophthalmology Clinic, 18980University of Messina, Messina, Italy.'}, {'ForeName': 'Alice Antonella', 'Initials': 'AA', 'LastName': 'Severo', 'Affiliation': 'Department of Biomedical and Dental Sciences and Morphofunctional Imaging, Ophthalmology Clinic, 18980University of Messina, Messina, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Camellin', 'Affiliation': 'Department of Biomedical and Dental Sciences and Morphofunctional Imaging, Ophthalmology Clinic, 18980University of Messina, Messina, Italy.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Rechichi', 'Affiliation': 'Centro Polispecialistico Mediterraneo, Sellia Marina, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Aragona', 'Affiliation': 'Department of Biomedical and Dental Sciences and Morphofunctional Imaging, Regional Referral Center for the Ocular Surface Diseases, 18980University of Messina, Messina, Italy.'}]",European journal of ophthalmology,['10.1177/11206721221083799']
2802,35229691,"Designing and implementing methodology for double-blind, placebo-controlled clinical trials using blood products within the Department of Veterans Affairs.","BACKGROUND


Success in conducting clinical trials during the coronavirus disease of 2019 pandemic requires the ability to innovate and adapt. There are well-established procedures for the blinding of investigational agents, especially medications, in placebo-controlled randomized clinical trials within the Veterans Health Administration. However, these procedures, managed by research pharmacists, may not apply to investigational agents that are not exclusively managed by pharmacy, such as blood products, including coronavirus disease of 2019 convalescent plasma (plasma). In the absence of established blinding procedures, such studies require special design considerations to minimize uncertainty or bias.
METHODS


We describe the processes and procedures developed for blinding of plasma in ""Veterans Affairs CoronavirUs Research and Efficacy Studies-1"" as a prototypical study using this class of investigational therapeutic agents. Veterans Affairs CoronavirUs Research and Efficacy Studies-1 is an ongoing multicenter randomized clinical trial testing the efficacy of plasma added to conventional therapy for severe acute respiratory syndrome coronavirus-2 infection.
RESULTS


We report the design of procedures to supply investigational blood products or 0.9% normal saline (saline) control while ensuring the integrity of the blind. Key aspects include workflow considerations, physical blinding strategies, and methods for engaging stakeholders. These procedures leverage the well-established Veterans Affairs research pharmacist's research infrastructure, and Blood Bank Services, which is responsible for blood-based investigational products.
CONCLUSION


By describing the methods used to deliver blood products in a blinded manner in Veterans Affairs CoronavirUs Research and Efficacy Studies-1, we strive both to educate and to increase awareness to improve the implementation of these biological therapeutics for future, high-quality research studies.",2022,"Veterans Affairs CoronavirUs Research and Efficacy Studies-1 is an ongoing multicenter randomized clinical trial testing the efficacy of plasma added to conventional therapy for severe acute respiratory syndrome coronavirus-2 infection.
",['severe acute respiratory syndrome coronavirus-2 infection'],"['supply investigational blood products or 0.9% normal saline (saline) control', 'plasma added to conventional therapy', 'placebo']",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439166', 'cui_str': '% normal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.328199,"Veterans Affairs CoronavirUs Research and Efficacy Studies-1 is an ongoing multicenter randomized clinical trial testing the efficacy of plasma added to conventional therapy for severe acute respiratory syndrome coronavirus-2 infection.
","[{'ForeName': 'Elliott K', 'Initials': 'EK', 'LastName': 'Miller', 'Affiliation': 'Department of Veterans Affairs, Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, USA.'}, {'ForeName': 'Alexa M', 'Initials': 'AM', 'LastName': 'Goldberg', 'Affiliation': 'Department of Veterans Affairs, Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, USA.'}, {'ForeName': 'Edward N', 'Initials': 'EN', 'LastName': 'Janoff', 'Affiliation': 'Rocky Mountain Regional VA Medical Center, Aurora, CO, USA.'}, {'ForeName': 'Sheldon T', 'Initials': 'ST', 'LastName': 'Brown', 'Affiliation': 'James J. Peters Department of Veterans Affairs Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Curtis', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Bonomo', 'Affiliation': 'Louis Stokes Cleveland VA Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Mei-Chiung', 'Initials': 'MC', 'LastName': 'Shih', 'Affiliation': 'Department of Veterans Affairs, Cooperative Studies Program Coordinating Center, Palo Alto, CA, USA.'}, {'ForeName': 'Theresa C', 'Initials': 'TC', 'LastName': 'Gleason', 'Affiliation': 'Department of Veterans Affairs, Clinical Science Research and Development Service, Washington, DC, USA.'}]","Clinical trials (London, England)",['10.1177/17407745211069703']
2803,35226799,Efficacy of Enzyme Replacement Therapy on the range of motion of the upper and lower extremities in 16 Polish patients with mucopolysaccharidosis type II: A long-term follow-up study.,"BACKGROUND


Enzyme replacement therapy (ERT) with idursulfase is available for patients with mucopolysaccharidosis (MPS) type II, and improvements in certain somatic signs and symptoms have been reported. The aim of the study was to assess the effectiveness of ERT with idursulfase (Elaprase®) on the passive joint range of motion (JROM) in the upper and lower extremities of patients with MPS II.
METHODS


The study included 16 Polish patients diagnosed with MPS II and followed in our Institute in the years 2009-2016. The study group was divided for groups of neuronopathic (group 1, n=12) and non-neuronopathic (group 2, n=4) patients. A passive JROM was measured with a goniometer by one physiotherapist, while in group 1 it was assessed at baseline and after both short-term (52 weeks) and long-term (mean 230 weeks, range: 108-332 weeks) ERT. In group 2, it was assessed at baseline and after short-term ERT (68-85 weeks, no data for long-term ERT).
RESULTS


In group 1, after 52 weeks of ERT, we observed some improvement of passive ROM in wrist flexion (5/12 patients), shoulder abduction and wrist extension (3/12 patients), shoulder flexion, elbow and knee extension (2/12 patients). After long-term ERT (mean 230 weeks), the improvement in JROM was observed only in 2 patients. There was no improvement in the shoulder abduction, elbow flexion and extension, hip and knee extension. In group 2, the improvement in passive ROM was observed in several joints: shoulder flexion, wrist flexion and extension improved (2/4 patients) and shoulder abduction (1/4 patients).
CONCLUSION


ERT is of low efficacy on correcting the range of motion of joints in MPS II patients.",2022,"In group 2, the improvement in passive ROM was observed in several joints: shoulder flexion, wrist flexion and extension improved (2/4 patients) and shoulder abduction (1/4 patients).
","['group 1, n=12) and non-neuronopathic (group 2, n=4) patients', '16 Polish patients with mucopolysaccharidosis type II', 'patients with mucopolysaccharidosis (MPS) type II', '16 Polish patients diagnosed with MPS II and followed in our Institute in the years 2009-2016', 'patients with MPS II']","['neuronopathic', 'Enzyme replacement therapy (ERT', 'Enzyme Replacement Therapy', 'ERT', 'ERT with idursulfase (Elaprase®']","['range of motion of the upper and lower extremities', 'passive ROM', 'JROM', 'passive joint range of motion (JROM', 'several joints: shoulder flexion, wrist flexion and extension', 'shoulder abduction', 'shoulder flexion, elbow and knee extension', 'passive ROM in wrist flexion', 'shoulder abduction, elbow flexion and extension, hip and knee extension', 'shoulder abduction and wrist extension']","[{'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0026705', 'cui_str': 'Mucopolysaccharidosis, MPS-II'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}, {'cui': 'C1429223', 'cui_str': 'IDS protein, human'}, {'cui': 'C2346466', 'cui_str': 'Elaprase'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}]",16.0,0.047941,"In group 2, the improvement in passive ROM was observed in several joints: shoulder flexion, wrist flexion and extension improved (2/4 patients) and shoulder abduction (1/4 patients).
","[{'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Marucha', 'Affiliation': ""Department of Pediatrics, Nutrition and Metabolic Diseases, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Patryk', 'Initials': 'P', 'LastName': 'Lipiński', 'Affiliation': ""Department of Pediatrics, Nutrition and Metabolic Diseases, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tylki-Szymańska', 'Affiliation': ""Department of Pediatrics, Nutrition and Metabolic Diseases, The Children's Memorial Health Institute, Warsaw, Poland.""}]",Acta biochimica Polonica,['10.18388/abp.2020_6071']
2804,35226769,Comparative evaluation of complete and partial pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis: A Randomized clinical trial.,"AIM


The study aimed to compare the outcome of complete pulpotomy (CP) and partial pulpotomy (PP) techniques, when utilised for the management of mature permanent teeth with carious pulpal exposure and symptomatic irreversible pulpitis (SIP).
METHODOLOGY


The study protocol was registered with ClinicalTrials.gov (NCT04397315). One hundred and six permanent mandibular molars with carious pulpal exposure and clinical diagnosis of SIP with periapical index (PAI) ≤ 2, from patients aged between 18-40 years were randomly allocated in equal proportion to either CP or PP group. Allocated procedures were performed using standardized protocols. The allocated procedure was abandoned in cases where pulpal bleeding could not be controlled within 6 minutes using cotton pellets soaked in 3 % sodium hypochlorite. MTA was used as a pulpotomy agent and teeth were restored using a base of glass ionomer followed by composite restoration. The pain was recorded by the patient preoperatively before administration of local anaesthesia and postoperatively every 24 hours for 1 week using Visual Analogue Scale (VAS). Success was analysed at 12 months based on clinical and radiographic examination. Mann Whitney U test was used to compare age, pain scores, and mean analgesic consumption between the groups. Categorical data were analysed using Chi-square test. Fisher's exact test was used to assess the clinical and radiographic success and incidence of pain. Kaplan Meier analysis was used to assess the survival of teeth. A p-value <0.05 was considered as statistically significant.
RESULTS


One hundred and one patients were analysed at follow up. Higher success was observed in CP (89.8 %) in comparison to PP group (80.8%), but the difference was non-significant statistically (p=0.202). Although no significant difference was observed in pain incidence between the groups at 24 hours (p=0.496), a significant difference in pain intensities was observed between groups at all the tested time intervals, with lower values reported in CP group (p<0.05).
CONCLUSIONS


Both CP and PP resulted in favourable outcomes in the management of cariously exposed permanent teeth with signs indicative of SIP. Given the more conservative nature of PP, it may be attempted first before proceeding to CP in such cases.",2022,"Although no significant difference was observed in pain incidence between the groups at 24 hours (p=0.496), a significant difference in pain intensities was observed between groups at all the tested time intervals, with lower values reported in CP group (p<0.05).
","['One hundred and six permanent mandibular molars with carious pulpal exposure and clinical diagnosis of SIP with periapical index (PAI) ≤ 2, from patients aged between 18-40 years', 'mature permanent teeth with carious pulpal exposure and symptomatic irreversible pulpitis (SIP', 'mature permanent teeth with symptomatic irreversible pulpitis']","['MTA', 'CP and PP', 'complete pulpotomy (CP) and partial pulpotomy (PP) techniques', 'CP or PP', 'complete and partial pulpotomy', 'cotton pellets soaked in 3 % sodium hypochlorite']","['pain', 'survival of teeth', 'CP', 'age, pain scores, and mean analgesic consumption', 'pain intensities', 'pain incidence', 'clinical and radiographic success and incidence of pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}]","[{'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010196', 'cui_str': 'Gossypium'}, {'cui': 'C0441436', 'cui_str': 'Pellet gun missile'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]",106.0,0.0250606,"Although no significant difference was observed in pain incidence between the groups at 24 hours (p=0.496), a significant difference in pain intensities was observed between groups at all the tested time intervals, with lower values reported in CP group (p<0.05).
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ramani', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak, 124001.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sangwan', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak, 124001.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tewari', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak, 124001.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Duhan', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak, 124001.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak, 124001.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak, 124001.'}]",International endodontic journal,['10.1111/iej.13714']
2805,35226756,Ego Impairment Index (EII-2) as a predictor of outcome in short- and long-term psychotherapy during a 5-year follow-up.,"OBJECTIVE


This study examined the predictive ability of the Rorschach-based Ego Impairment Index (EII-2) on outcome of psychotherapy in different types and durations of therapy.
METHOD


A total of 326 outpatients suffering from depressive or anxiety disorders were randomized into receiving solution-focused (n = 97), short-term psychodynamic (n = 101), or long-term psychodynamic psychotherapy (n = 128). Psychotherapy outcome assessments during the 5-year follow-up period covered psychiatric symptoms, social functioning, and work ability.
RESULTS


Lower EII-2 values, which indicate less problematic ego functioning, were found to predict faster improvement in both short-term therapies as compared to long-term psychotherapy.
CONCLUSION


The results provide preliminary support for the utility of EII-2 as a complementary measure to interview-based methods for selecting between short- and long-term therapies.",2022,The results provide preliminary support for the utility of EII-2 as a complementary measure to interview-based methods for selecting between short- and long-term therapies.,['326 outpatients suffering from depressive or anxiety disorders'],"['Rorschach-based Ego Impairment Index (EII-2', 'short-term psychodynamic (n\u2009=\u2009101), or long-term psychodynamic psychotherapy']","['5-year follow-up period covered psychiatric symptoms, social functioning, and work ability']","[{'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0070846', 'cui_str': 'phosphoenolpyruvate-mannose phosphotransferase'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0579055', 'cui_str': 'Long-term psychodynamic psychotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",326.0,0.0578738,The results provide preliminary support for the utility of EII-2 as a complementary measure to interview-based methods for selecting between short- and long-term therapies.,"[{'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Stenius', 'Affiliation': 'Department of Psychiatry, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Erkki', 'Initials': 'E', 'LastName': 'Heinonen', 'Affiliation': 'Department of Public Health and Welfare, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Olavi', 'Initials': 'O', 'LastName': 'Lindfors', 'Affiliation': 'Department of Public Health and Welfare, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Holma', 'Affiliation': 'Department of Psychology, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knekt', 'Affiliation': 'Department of Public Health and Welfare, Finnish Institute for Health and Welfare, Helsinki, Finland.'}]",Journal of clinical psychology,['10.1002/jclp.23332']
2806,35226749,36-Month Randomized Clinical Trial Evaluation of Preheated and Room Temperature Resin Composite.,"OBJECTIVE


This study evaluated the effect of preheating resin composites (RCs) on the clinical performance of class I restorations during a 36-month period using a split-mouth, double-blinded randomized design.
METHODS AND MATERIALS


A total of 35 patients were selected. Every patient received one pair of class I nanofilled resin composite (RC, Filtek Z350 XT) posterior restorations (n=70). One side of the mouth received preheated composites; on the other side, the composite was placed in a nonheated state following the manufacturer's instructions. These restorations were evaluated at 1-week (baseline), 12-months, 24-months, and 36-months using the FDI World Dental Federation criteria. The statistical analyses were also performed using the Wilcoxon and Friedman tests with the level of significance set at 0.05.
RESULTS


After 36 months, 33 patients attended the recall visits, and 66 restorations were evaluated. The Friedman and Wilcoxon signed-rank tests revealed insignificant differences between both groups (p>0.05) for all FDI parameters. However, a significant difference was detected for staining as a criterion at 36 months (p=0.01). Moreover, a significant difference in the staining was detected when the baseline and 36 months were compared in the nonheated RC group (p=0.001). For esthetic, functional, and biological properties, the nonheated composite exhibited 93.9%, 100%, and 100% of the clinically accepted scores, respectively, and the preheated group presented 100% for all properties. Four restorations had postoperative sensitivity at baseline for nonheated (11.4%) and five for preheated (14.2%), but the postoperative sensitivity scores were considered highly acceptable at 12-, 24-, and 36-months.
CONCLUSIONS


After 36 months, preheated nanofilled RCs showed an acceptable clinical performance similar to that of the nonheated ones in class I restorations, but with better resistance to marginal staining.",2022,The Friedman and Wilcoxon signed-rank tests revealed insignificant differences between both groups (p>0.05) for all FDI parameters.,"['A total of 35 patients were selected', '33 patients attended the recall visits, and 66 restorations were evaluated']","['Preheated and Room Temperature Resin Composite', 'preheating resin composites (RCs']","['postoperative sensitivity scores', 'postoperative sensitivity']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",35.0,0.132521,The Friedman and Wilcoxon signed-rank tests revealed insignificant differences between both groups (p>0.05) for all FDI parameters.,"[{'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Elkaffas', 'Affiliation': ''}, {'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Eltoukhy', 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Elnegoly', 'Affiliation': ''}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Mahmoud', 'Affiliation': ''}]",Operative dentistry,['10.2341/20-301-C']
2807,35226724,"Basal Infusion versus Automated Boluses and a Delayed Start Timer for ""Continuous"" Sciatic Nerve Blocks following Ambulatory Foot and Ankle Surgery A Randomized, Clinical Trial.","BACKGROUND.


The common technique using a basal infusion for an ambulatory continuous peripheral nerve blocks frequently results in exhaustion of the local anesthetic reservoir prior to resolution of surgical pain. We sought to improve and prolong analgesia by delaying initiation using an integrated timer and delivering a lower hourly volume of local anesthetic as automated boluses. We hypothesized that, compared with a traditional continuous infusion, ropivacaine administered with automated boluses at a lower dose and 5-hour delay would (1) provide at least noninferior analgesia [difference in average pain no greater than 1.7 points] while both techniques were functioning [average pain score day after surgery]; and, (2) result in a longer duration [dual primary outcomes].
METHODS.


Participants (n = 70) undergoing foot or ankle surgery with a popliteal-sciatic catheter received an injection of ropivacaine 0.5% with epinephrine (20 mL) then were randomized to receive ropivacaine (0.2%) as either continuous infusion (6 mL/h) initiated prior to discharge, or automated boluses (8 mL every 2 h) initiated 5 hours following discharge using a timer. Both groups could self-deliver supplemental boluses (4 mL, lockout 30 min); participants and outcomes assessors were blinded to randomization. All randomized participants were included in data analysis.
RESULTS.


The day following surgery, participants with automated boluses had a median [IQR] pain score of 0.0 [0.0 to 3.0] vs. 3.0 [1.8 to 4.8] for the continuous infusion group: odds ratio 3.1 (95% CI 1.23 to 7.84, p=0.033) adjusting for BMI. Reservoir exhaustion in automated boluses group occurred after a median [IQR] of 119 h [109,125] vs. 74 h [57,80] for continuous infusion group: difference 47h (95% CI: 38 to 55), P<0.001 adjusting for BMI.
CONCLUSIONS


For popliteal-sciatic catheters, replacing a continuous infusion initiated before discharge with automated boluses and a start-delay timer resulted in better analgesia and longer infusion duration.",2022,"The day following surgery, participants with automated boluses had a median [IQR] pain score of 0.0 [0.0 to 3.0] vs. 3.0 [1.8 to 4.8] for the continuous infusion group: odds ratio 3.1 (95% CI 1.23 to 7.84, p=0.033) adjusting for BMI.",['Participants (n = 70) undergoing foot or ankle surgery with a popliteal-sciatic catheter received an injection of'],"['Basal Infusion versus Automated Boluses and a Delayed Start Timer for ""Continuous"" Sciatic Nerve Blocks following Ambulatory Foot and Ankle Surgery', 'ropivacaine', 'ropivacaine 0.5% with epinephrine']","['median [IQR] pain score', 'Reservoir exhaustion']","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0188412', 'cui_str': 'Operative procedure on ankle'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0183941', 'cui_str': 'Timer'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0188412', 'cui_str': 'Operative procedure on ankle'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0442537', 'cui_str': 'Reservoir'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}]",70.0,0.709444,"The day following surgery, participants with automated boluses had a median [IQR] pain score of 0.0 [0.0 to 3.0] vs. 3.0 [1.8 to 4.8] for the continuous infusion group: odds ratio 3.1 (95% CI 1.23 to 7.84, p=0.033) adjusting for BMI.","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Finneran', 'Affiliation': 'University of California San Diego, Department of Anesthesiology, San Diego, CA.'}, {'ForeName': 'Engy T', 'Initials': 'ET', 'LastName': 'Said', 'Affiliation': 'University of California San Diego, Department of Anesthesiology, San Diego, CA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Curran', 'Affiliation': 'University of California San Diego, Department of Anesthesiology, San Diego, CA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Swisher', 'Affiliation': 'University of California San Diego, Department of Anesthesiology, San Diego, CA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Black', 'Affiliation': 'University of California San Diego, Department of Anesthesiology, San Diego, CA.'}, {'ForeName': 'Rodney A', 'Initials': 'RA', 'LastName': 'Gabriel', 'Affiliation': 'University of California San Diego, Department of Anesthesiology, San Diego, CA.'}, {'ForeName': 'Jacklynn F', 'Initials': 'JF', 'LastName': 'Sztain', 'Affiliation': 'University of California San Diego, Department of Anesthesiology, San Diego, CA.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'Abramson', 'Affiliation': 'University of California San Diego, Department of Anesthesiology, San Diego, CA.'}, {'ForeName': 'Brenton', 'Initials': 'B', 'LastName': 'Alexander', 'Affiliation': 'University of California San Diego, Department of Anesthesiology, San Diego, CA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Donohue', 'Affiliation': 'University of Southern California, Department of Neurology, Los Angeles, CA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Schaar', 'Affiliation': 'University of California San Diego, Department of Anesthesiology, San Diego, CA.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Ilfeld', 'Affiliation': 'University of California San Diego, Department of Anesthesiology, San Diego, CA.'}]",Anesthesiology,['10.1097/ALN.0000000000004189']
2808,35226703,"Effects of compression garment on muscular efficacy, proprioception, and recovery after exercise-induced muscle fatigue onset for people who exercise regularly.","Fatigue is a major cause of exercise-induced muscle damage (EIMD). Compression garments (CGs) can aid post-exercise recovery, therefore, this study explored the effects of CGs on muscular efficacy, proprioception, and recovery after exercise-induced muscle fatigue in people who exercise regularly. Twelve healthy participants who exercised regularly were enrolled in this study. Each participant completed an exercise-induced muscle fatigue test while wearing a randomly assigned lower-body CG or sports pants (SP); after at least 7 days, the participant repeated the test while wearing the other garment. The dependent variables were muscle efficacy, proprioception (displacements of center of pressure/COP, and absolute error), and fatigue recovery (muscle oxygen saturation/SmO2, deoxygenation and reoxygenation rate, and subjective muscle soreness). A two-way repeated measure analysis of variance was conducted to determine the effect of garment type. The results indicated that relative to SP use, CG use can promote muscle efficacy, proprioception in ML displacement of COP, and fatigue recovery. Higher deoxygenation and reoxygenation rates were observed with CG use than with SP use. For CG use, SmO2 quickly returned to baseline value after 10 min of rest and was maintained at a high level until after 1 h of rest, whereas for SP use, SmO2 increased with time after fatigue onset. ML displacement of COP quickly returned to baseline value after 10 min of rest and subsequently decreased until after 1 hour of rest. Relative to SP use, CG use was associated with a significantly lower ML displacement after 20 min of rest. In conclusion, proprioception and SmO2 recovery was achieved after 10 min of rest; however, at least 24 h may be required for recovery pertaining to muscle efficacy and soreness regardless of CG or SP use.",2022,ML displacement of COP quickly returned to baseline value after 10 min of rest and subsequently decreased until after 1 hour of rest.,"['Twelve healthy participants who exercised regularly were enrolled in this study', 'people who exercise regularly']","['compression garment', 'Compression garments (CGs', 'exercise-induced muscle fatigue test while wearing a randomly assigned lower-body CG or sports pants (SP']","['muscle efficacy, proprioception (displacements of center of pressure/COP, and absolute error), and fatigue recovery (muscle oxygen saturation/SmO2, deoxygenation and reoxygenation rate, and subjective muscle soreness', 'proprioception and SmO2 recovery', 'muscular efficacy, proprioception, and recovery', 'muscle efficacy, proprioception in ML displacement of COP, and fatigue recovery', 'Higher deoxygenation and reoxygenation rates']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0556454', 'cui_str': 'Exercises regularly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C2985539', 'cui_str': 'Compression garment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0425488', 'cui_str': 'Rapid shallow breathing'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0205250', 'cui_str': 'High'}]",12.0,0.0436167,ML displacement of COP quickly returned to baseline value after 10 min of rest and subsequently decreased until after 1 hour of rest.,"[{'ForeName': 'Wei-Hsien', 'Initials': 'WH', 'LastName': 'Hong', 'Affiliation': 'Department of Sports Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Sui-Foon', 'Initials': 'SF', 'LastName': 'Lo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Wu', 'Affiliation': 'Department of Industrial Engineering and Management, Chaoyang University of Technology, Taichung, Taiwan.'}, {'ForeName': 'Min-Chi', 'Initials': 'MC', 'LastName': 'Chiu', 'Affiliation': 'Department of Industrial Engineering & Management, National Chin-Yi University of Technology, Taichung, Taiwan.'}]",PloS one,['10.1371/journal.pone.0264569']
2809,35227112,Increases in Muscle-Strengthening Activities Among Latinas in Seamos Saludables.,"BACKGROUND


Only 17% of Latinas meet national physical activity (PA) guidelines for both moderate-to-vigorous aerobic and muscle-strengthening PA. Additional health benefits are derived from the combination of aerobic and muscle-strengthening PA (vs. aerobic alone), yet there is paucity in research on muscle-strengthening activity in Latinas. The aim of this study was to examine changes in muscle-strengthening activity from baseline to 6 and 12 months in  Seamos Saludables , a 12-month PA randomized controlled trial for Latinas.
METHODS


A secondary data analysis was conducted among 131 Latinas ages 18-65 years, who were randomized to either a PA Intervention or a Wellness Control. Self-reported muscle-strengthening exercise was measured at baseline, 6 months, and 12 months via adapted muscle-strengthening questions from the Behavioral Risk Factor Surveillance System.
RESULTS


There was a 16-minute/week difference in median minute/week of muscle-strengthening activity between Intervention and Wellness at 6 months ( SE  = 7.91,  p  = .04) and 45-minute/week difference at 12 months ( SE  = 25.80,  p  = .06) adjusting for baseline. Significantly more PA Intervention participants met muscle-strengthening guidelines of 2 or more days/week at 6 months versus Wellness Control participants (odds ratio [OR] = 4.29, 95% confidence interval [CI] = [1.03, 17.84]).
CONCLUSION


Results from the current study showed that Latinas engaged in muscle-strengthening activity in an intervention that emphasized primarily aerobic PA outcomes, suggesting they may be interested in engaging in muscle-strengthening activities. Future interventions targeting both aerobic and muscle-strengthening activity could achieve greater health improvements and help more Latinas reach the full national PA guidelines. ClinicalTrials.gov Identifier.  NCT01583140.",2022,"There was a 16-minute/week difference in median minute/week of muscle-strengthening activity between Intervention and Wellness at 6 months ( SE  = 7.91,  p  = .04) and 45-minute/week difference at 12 months ( SE  = 25.80,  p  = .06) adjusting for baseline.",['131 Latinas ages 18-65 years'],['PA Intervention or a Wellness Control'],"['Muscle-Strengthening Activities', 'median minute/week of muscle-strengthening activity', 'Self-reported muscle-strengthening exercise', 'muscle-strengthening activity']","[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]",131.0,0.182645,"There was a 16-minute/week difference in median minute/week of muscle-strengthening activity between Intervention and Wellness at 6 months ( SE  = 7.91,  p  = .04) and 45-minute/week difference at 12 months ( SE  = 25.80,  p  = .06) adjusting for baseline.","[{'ForeName': 'Tanya J', 'Initials': 'TJ', 'LastName': 'Benitez', 'Affiliation': 'Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Dunsiger', 'Affiliation': 'Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Marquez', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Larsen', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Dori', 'Initials': 'D', 'LastName': 'Pekmezi', 'Affiliation': 'The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Brown University School of Public Health, Providence, RI, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/10901981221074908']
2810,35227041,Effects of C-Factor on Bond Strength of Universal Adhesives to Floor and Wall Dentin in Class-I Composite Restorations.,"PURPOSE


To evaluate the effects of C-factor on the bond strength of universal adhesives to floor and wall dentin in class-I composite restorations using a bulk-fill composite.
MATERIALS AND METHODS


108 non-carious humans third molars were randomly divided into four groups as follows: flat wall, flat floor, cavity wall, and cavity floor (n = 36). Then, each group was subdivided into three subgroups according to the type of adhesive used: Single Bond Universal, G-premio Bond (both universal adhesives), or Adper Single Bond 2 (an etch-and-rinse adhesive). After the bonding procedure, X-tra fill resin composite was applied in bulk to build up the flat surfaces or fill the cavities.Then the teeth were sectioned into 1-mm2 sticks and microtensile bond strength (µTBS) was measured using a universal testing machine. µTBS (MPa) was analyzed by one-way, two-way, and three-way ANOVA using SPSS Version 23 (a = 0.05).
RESULTS


Interactions between adhesives and bonding surfaces, as well as C-factor and bonding surfaces showed statistically significant differences, but the interaction between the C-factor and type of adhesive was not statistically significant. The comparison of bonded surfaces including the flat wall and the flat floor in Adper Single Bond 2 was statistically significant (p < 0.05), except for the cavity wall and cavity floor.
CONCLUSION


Regardless of the type of adhesives, the C-factor reduced the µTBS of the composite resin to dentin. Adper Single Bond 2 mediated higher µTBS than did the universal adhesives G-premio Bond and Single Bond Universal.",2022,Adper Single Bond 2 mediated higher µTBS than did the universal adhesives G-premio Bond and Single Bond Universal.,"['Universal Adhesives to Floor and Wall Dentin in Class-I Composite Restorations', '108 non-carious humans third molars']",['C-Factor'],"['µTBS (MPa', 'microtensile bond strength (µTBS']","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C1295487', 'cui_str': 'Limulus clotting factor C'}]","[{'cui': 'C0025147', 'cui_str': 'Medroxyprogesterone'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",108.0,0.0461394,Adper Single Bond 2 mediated higher µTBS than did the universal adhesives G-premio Bond and Single Bond Universal.,"[{'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Fazelian', 'Affiliation': ''}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Kasraei', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Khamverdi', 'Affiliation': ''}]",The journal of adhesive dentistry,['10.3290/j.jad.b2701599']
2811,35226949,Evaluation of a Zingiber officinale and Bixa orellana Supplement on the Gut Microbiota of Male Athletes: A Randomized Placebo-Controlled Trial.,"The gut microbiota has emerged as a factor that influences exercise performance and recovery. The present study aimed to test the effect of a polyherbal supplement containing ginger and annatto called ""ReWin(d)"" on the gut microbiota of recreational athletes in a pilot, randomized, triple-blind, placebo-controlled trial. Thirty-four participants who practice physical activity at least three times weekly were randomly allocated to two groups, a ReWin(d) group or a maltodextrin (placebo) group. We evaluated the gut microbiota, the production of short-chain fatty acids, and the serum levels of interleukin-6 and lipopolysaccharide at baseline and after 4 weeks. Results showed that ReWin(d) supplementation slightly increased gut microbiota diversity. Pairwise analysis revealed an increase in the relative abundance of  Lachnospira  ( β -coefficient = 0.013; p = 0.001),  Subdoligranulum  ( β -coefficient = 0.016; p = 0.016),  Roseburia  ( β -coefficient = 0.019; p = 0.001), and  Butyricicoccus  ( β -coefficient = 0.005; p = 0.035) genera in the ReWin(d) group, and a decrease in  Lachnoclostridium  ( β -coefficient = - 0.008; p = 0.009) and the Christensenellaceae R7 group ( β -coefficient = - 0.010; p < 0.001). Moreover, the Christensenellaceae R-7 group correlated positively with serum interleukin-6 (ρ = 0.4122; p = 0.032), whereas the  Lachnospira  genus correlated negatively with interleukin-6 (ρ = - 0.399; p = 0.032). ReWin(d) supplementation had no effect on short-chain fatty acid production or on interleukin-6 or lipopolysaccharide levels.",2022,"Pairwise analysis revealed an increase in the relative abundance of  Lachnospira  ( β -coefficient = 0.013; p = 0.001),  Subdoligranulum  ( β -coefficient = 0.016; p = 0.016),  Roseburia  ( β -coefficient = 0.019; p = 0.001), and  Butyricicoccus  ( β -coefficient = 0.005; p = 0.035) genera in the ReWin(d) group, and a decrease in  ","['gut microbiota of recreational athletes', 'Male Athletes', 'Thirty-four participants who practice physical activity at least three times weekly']","['placebo', 'Placebo', 'Zingiber officinale and Bixa orellana Supplement', 'polyherbal supplement containing ginger and annatto called ""ReWin(d', 'ReWin(d) supplementation', 'maltodextrin (placebo']","['relative abundance of  Lachnospira', 'short-chain fatty acid production or on interleukin-6 or lipopolysaccharide levels', 'gut microbiota diversity', 'serum interleukin-6', 'Gut Microbiota']","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C1026070', 'cui_str': 'Bixa'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0051928', 'cui_str': 'Annatto Extract'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0317586', 'cui_str': 'Lachnospira'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",34.0,0.174278,"Pairwise analysis revealed an increase in the relative abundance of  Lachnospira  ( β -coefficient = 0.013; p = 0.001),  Subdoligranulum  ( β -coefficient = 0.016; p = 0.016),  Roseburia  ( β -coefficient = 0.019; p = 0.001), and  Butyricicoccus  ( β -coefficient = 0.005; p = 0.035) genera in the ReWin(d) group, and a decrease in  ","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Domínguez-Balmaseda', 'Affiliation': 'Masmicrobiota Group, Faculty of Health Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Madrid, Spain.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Bressa', 'Affiliation': 'Masmicrobiota Group, Faculty of Health Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Madrid, Spain.'}, {'ForeName': 'Arantxa', 'Initials': 'A', 'LastName': 'Fernández-Romero', 'Affiliation': 'Masmicrobiota Group, Faculty of Health Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'de Lucas', 'Affiliation': 'Masmicrobiota Group, Faculty of Health Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Madrid, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Pérez-Ruiz', 'Affiliation': 'Research Group on Exercise, health and biomarkers applied, Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Madrid, Spain.'}, {'ForeName': 'Alejandro F', 'Initials': 'AF', 'LastName': 'San Juan', 'Affiliation': 'Department of Health and Human Performance, Sport Biomechanics Laboratory, Faculty of Physical Activity and Sport Sciences, INEF, Universidad Politécnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Roller', 'Affiliation': 'Natural Origins, Lozanne, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Issaly', 'Affiliation': 'Nicolas Issaly, Valencia, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Larrosa', 'Affiliation': 'Masmicrobiota Group, Faculty of Health Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Madrid, Spain.'}]",Planta medica,['10.1055/a-1671-5766']
2812,35226933,Predictive Value of Preoperative Endoscopic Ultrasound (EUS) After Neoadjuvant Chemotherapy in Locally Advanced Esophagogastric Cancer - Data From a Randomized German Phase II Trial.,"PURPOSE


The role of EUS before or after neoadjuvant chemotherapy (nCTX) in advanced esophagogastric cancer (EGC) is still unclear. The phase II NEOPECX trial evaluated perioperative chemotherapy with or without panitumumab in this setting. The aim of this sub-study was to investigate the prognostic value of EUS-guided preoperative staging before and after nCTX.
MATERIALS AND METHODS


Preoperative yuT/yuN stages by EUS were compared with histopathological ypT/ypN stages after curative resection. Reduction in T-stage from baseline to preoperative EUS was defined as downstaging (DS+) and compared to progression-free (PFS) and overall survival (OS) of patients without downstaging (DS-). In addition, preoperative EUS N-stages (positive N+ or negative N-) were correlated with clinical data.
RESULTS


The preoperative yuT-stage correlated with the ypT-stage in 48% of cases (sensitivity 48%, specificity 52%), while the preoperative yuN-stage correlated with the ypN-stage in 64% (sensitivity 76%, specificity 52%). Within DS+ patients who were downstaged by ≥ 2 T-categories, a trend towards improved OS was detected (median OS DS+: not reached (NR), median OS DS-: 38.5 months (M), p=0.21). Patients with yuN+ at preoperative EUS had a worse outcome than yuN- patients (median OS yuN-: NR, median OS yuN+: 38.5 M, p = 0.013).
CONCLUSION


The diagnostic accuracy of EUS to predict the response after nCTX in patients with advanced EGC is limited. In the current study the endosonographic detection of lymph node metastasis after nCTX indicates a poor prognosis. In the future, preoperative EUS with sectional imaging procedures may be used to tailor treatment for patients with advanced EGC.",2022,"Patients with yuN+ at preoperative EUS had a worse outcome than yuN- patients (median OS yuN-: NR, median OS yuN+: 38.5 M, p = 0.013).
","['patients with advanced EGC', 'Preoperative yuT/yuN stages by EUS were compared with histopathological ypT/ypN stages after curative resection', 'advanced esophagogastric cancer (EGC']","['Preoperative Endoscopic Ultrasound (EUS', 'Neoadjuvant Chemotherapy', 'neoadjuvant chemotherapy (nCTX', 'perioperative chemotherapy with or without panitumumab', 'EUS-guided preoperative staging before and after nCTX']","['OS', 'progression-free (PFS) and overall survival (OS', 'preoperative EUS N-stages (positive N+ or negative N']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332305', 'cui_str': 'With staging'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0456532', 'cui_str': 'N category'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.0909064,"Patients with yuN+ at preoperative EUS had a worse outcome than yuN- patients (median OS yuN-: NR, median OS yuN+: 38.5 M, p = 0.013).
","[{'ForeName': 'Visvakanth', 'Initials': 'V', 'LastName': 'Sivanathan', 'Affiliation': 'Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Utz', 'Affiliation': 'Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Thomaidis', 'Affiliation': 'Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Förster', 'Affiliation': 'Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stahl', 'Affiliation': 'Department of Medical Oncology, Hospitals Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lordick', 'Affiliation': 'University Cancer Center Leipzig (UCCL), University of Leipzig Faculty of Medicine, Leipzig, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ibach', 'Affiliation': 'Biostatistik, WiSP Wissenschaftlicher Service Pharma GmbH, Langenfeld, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kanzler', 'Affiliation': 'Department of Internal Medicine II,, Leopoldina Hospital Schweinfurt, Schweinfurt, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Adler', 'Affiliation': 'Medical Department, Division of Hepatology and Gastroenterology, Charite University Hospital Berlin, Berlin, Germany.'}, {'ForeName': 'Stefan Paul', 'Initials': 'SP', 'LastName': 'Mönig', 'Affiliation': 'Department of Visceral Surgery, University Hospitals Geneva, Geneve, Switzerland.'}, {'ForeName': 'Carl C', 'Initials': 'CC', 'LastName': 'Schimanski', 'Affiliation': 'Department of Internal Medicine II, Hospital Darmstadt GmbH, Darmstadt, Germany.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Ignee', 'Affiliation': 'Department of Internal Medicine II, Caritas Hospital Bad Mergentheim, Bad Mergentheim, Germany.'}, {'ForeName': 'Christoph F', 'Initials': 'CF', 'LastName': 'Dietrich', 'Affiliation': 'Department of General and Internal Medicine, Hirslanden Clinic Beau Site, Salem and Permanence, Bern, Switzerland.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': 'Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.'}]","Ultraschall in der Medizin (Stuttgart, Germany : 1980)",['10.1055/a-1593-4401']
2813,35226914,Self-Reported Changes in Thirst and Alertness during Variable Prescribed Fluid Intake.,"BACKGROUND


Maintaining euhydration is beneficial for health, safety, and physical performance [<xref ref-type=""bibr"" rid=""ref1"">1</xref>]; however, it may also improve subjective feelings [<xref ref-type=""bibr"" rid=""ref2"">2</xref>, <xref ref-type=""bibr"" rid=""ref3"">3</xref>].
OBJECTIVE


The aim of this study was to evaluate the relationship between changes in self-reported thirst and alertness in people undergoing changes in drinking water volume.
METHODS


Subjects (mean ± SD) (n = 115, 59 males, 32 ± 10 years; 24.6 ± 4.4 kg·m-2) visited the lab 3 times over 10 days: V1, a baseline visit prior to participants were drinking ad libitum; V2, following 3 days of fluid restriction (1 L·d-1, 250 mL was consumed in the morning prior to the visit); and V3, the morning following a prescribed increase in water intake. The increase in water intake at V3 varied by group assignment: control group (CON) maintained 250 mL, while LOW and HIGH groups (n = 45 each) consumed 496 ± 82 mL and 878 ± 125 mL, respectively. At each visit, subjects indicated on an open-ended visual analog scale (VAS) how thirsty and alert they felt and were measured in millimeters (mm). Four, two-way ANOVAs (group × visit) for change in thirst and alertness between V1-V2 and V2-V3 were completed. A repeated-measures correlation (rrm) procedure was completed for change in alertness and thirst from V1 to V2 and V2 to V3 [<xref ref-type=""bibr"" rid=""ref4"">4</xref>]. The study was approved by the University of Wyoming's Institutional Review Board (protocol #20160524EJ01208), and all subjects provided written informed consent.
RESULTS


Groups were similar at baseline (V1) for fluid intake, thirst, and alertness (all p ≥ 0.17). Fluid restriction (V2) resulted in a main effect of visit for thirst and alertness (both p < 0.01), with no main effect of group. Thirst increased (35 ± 35 mm) and alertness decreased (-19 ± 31 mm) from V1 to V2. The prescribed increase in water intake (V3) revealed a significant interaction of visit and group for thirst and alertness (both p < 0.01) (Table <xref ref-type=""table"" rid=""t01"">1</xref>). Independent-samples t tests with a Bonferroni correction revealed that HIGH reduced thirst (-38 ± 37 mm) and increased alertness (18 ± 25 mm), while no change was observed for LOW (thirst, -7 ± 37 mm; alertness -1 ± 24 mm) and CON (thirst, -6 ± 23 mm; alertness 0 ± 23 mm; all p < 0.01) (Fig. <xref ref-type=""fig"" rid=""f01"">1</xref>). There was no difference between LOW and CON (both p > 0.92). Repeated-measures correlation analysis revealed an inverse relationship between change in alertness and thirst (rrm [114] = -0.53, 95% CI [-0.65, -0.38], p < 0.01).
CONCLUSION


A reduction in water intake resulted in an increase in thirst and decrease in alertness. Following 3 days of fluid restriction, 750-1,000 mL of water intake was needed to decrease thirst and increase alertness. Overall, an inverse relationship was observed between self-reported thirst and alertness.",2021,Thirst increased (35 ± 35 mm) and alertness decreased (-19 ± 31 mm) from V1 to V2.,"['Subjects (mean ± SD) (n = 115, 59 males, 32 ± 10 years; 24.6 ± 4.4 kg·m-2) visited the lab 3 times over 10 days: V1, a baseline visit prior to participants', 'people undergoing changes in drinking water volume']",[],"['LOW and CON', 'increased alertness', 'alertness', 'water intake']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}]",,0.0758873,Thirst increased (35 ± 35 mm) and alertness decreased (-19 ± 31 mm) from V1 to V2.,"[{'ForeName': 'Hillary A', 'Initials': 'HA', 'LastName': 'Yoder', 'Affiliation': 'Exercise Physiology Lab, University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Ainsley E', 'Initials': 'AE', 'LastName': 'Huffman', 'Affiliation': 'Human Integrated Physiology Laboratory, University of Wyoming, Laramie, Wyoming, USA.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'McCullough', 'Affiliation': 'Human Integrated Physiology Laboratory, University of Wyoming, Laramie, Wyoming, USA.'}, {'ForeName': 'Evan C', 'Initials': 'EC', 'LastName': 'Johnson', 'Affiliation': 'Human Integrated Physiology Laboratory, University of Wyoming, Laramie, Wyoming, USA.'}]",Annals of nutrition & metabolism,['10.1159/000521066']
2814,35226904,The Acute Effect of Adequate Water Intake on Glucose Regulation in Low Drinkers.,"BACKGROUND


Arginine vasopressin (AVP), a key hormone in fluid balance, may be a modifiable contributor to hyperglycemia [<xref ref-type=""bibr"" rid=""ref1"">1</xref>]. Low daily water drinkers often exhibit increased urine concentration and copeptin, a surrogate marker for AVP [<xref ref-type=""bibr"" rid=""ref2"">2</xref>, <xref ref-type=""bibr"" rid=""ref3"">3</xref>].
OBJECTIVE


The primary purpose was to investigate the acute effect of adequate water intake on daily glucose concentration in low drinkers. Secondarily, the study examined if adequate water intake could improve glucoregulatory hormonal profiles in low drinkers.
METHODS


Seven healthy (5 males, 2 females; age 43 ± 7 years, BMI 31 ± 3) low drinkers were recruited using a water frequency questionnaire and a 24-h urine sample. Participants were recruited using social media channels and flyers in local community. Classification of a low drinker was defined by a fluid intake (water and other beverages) <1.5 L·day-1 in males or <1.0 L·day-1 in females and a 24-h·UOsm of >800 mmol·kg-1. In a crossover counterbalanced design, participants remained in the laboratory for 11 h (07:00-18:00) and were provided either the Institute of Medicine's recommended amount of water excluding fluid from food (males: 3 L·day-1, females: 2 L·day-1; high water intake, HWI) or an amount representing the bottom quartile of water consumption observed in the National Health and Nutrition Examination Survey (males: 0.5 L·day-1, females: 0.4 L·day-1; low iater intake, LWI) (Table 1) [<xref ref-type=""bibr"" rid=""ref4"">4</xref>, <xref ref-type=""bibr"" rid=""ref5"">5</xref>]. Caloric intake was standardized to body weight (100 kJ·kg-1) with an identical ratio of macronutrients and time of consumption between trials (Table 1). At 07:00, fasted baseline blood was drawn. Subsequent blood draws performed across the next 11 hours were analyzed for copeptin, glucose, insulin, glucagon, cortisol, and GLP-1 (Table 1). All urine voids during the 11-h protocol were pooled and analyzed for osmolality and glucose (n = 4). A two-way (water intake × time) repeated-measures ANOVA was used to determine differences in hydration and glucoregulatory measures. Dependent t tests were used to measure differences in urine samples. Statistical significance was determined a priori at an alpha of 0.05.
RESULTS


Participants were confirmed as low drinkers according to daily fluid intake, 24-h·UOsm, and copeptin (water frequency questionnaire volume: 823 ± 403 mL·day-1, 24-h·UOsm: 961 ± 105 mmol·kg-1, copeptin: 8.17 ± 3.05 pmol·L-1). During the experiments, 11-h·UOsm (HWI: 224 ± 48 mmol·kg-1, LWI: 956 ± 120 mmol·kg-1), plasma osmolality, and copeptin were lower in HWI as than in LWI (p = < 0.05, Fig. 1). There was a borderline significant main effect of water intake on plasma glucose (p = 0.07, Fig. 2) and total urinary glucose output (HWI: 51.4 ± 6.9 mg, LWI: 40.1 ± 10.4 mg, p = 0.07). Cortisol was significantly higher in LWI as than in HWI (p = 0.009, Fig. 2); however, no pairwise differences were observed in post hoc analysis. Glucagon, insulin, and GLP-1 were similar between trials (p > 0.05).
CONCLUSION


Acute increases in water intake may mildly reduce daily plasma glucose concentrations in low drinkers. This may be due to acutely increased urinary glucose output when low drinkers are given adequate amounts of water. Increased water intake also led to decreased cortisol concentration.",2021,"Cortisol was significantly higher in LWI as than in HWI (p = 0.009, Fig. 2); however, no pairwise differences were observed in post hoc analysis.","['Seven healthy (5 males, 2 females; age 43 ± 7 years, BMI 31 ± 3) low drinkers were recruited using a water frequency questionnaire and a 24-h urine sample', 'Participants were confirmed as low drinkers according to daily fluid intake, 24-h·UOsm, and copeptin (water frequency questionnaire volume: 823 ± 403 mL·day-1, 24-h·UOsm: 961 ± 105 mmol·kg-1, copeptin: 8.17 ± 3.05 pmol·L-1', ""participants remained in the laboratory for 11 h (07:00-18:00) and were provided either the Institute of Medicine's recommended amount of water excluding fluid from food (males: 3 L·day-1, females: 2"", 'Participants were recruited using social media channels and flyers in local community', 'Low Drinkers', 'males or <1.0 L·day-1 in females and a 24-h·UOsm of >800 mmol·kg-1', 'low drinkers']","['Adequate Water Intake', 'Arginine vasopressin (AVP', 'L·day-1; high water intake, HWI) or an amount representing the bottom quartile of water consumption observed in the National Health and Nutrition Examination Survey (males: 0.5 L·day-1, females: 0.4 L·day-1; low iater intake, LWI) (Table 1) [<xref ref-type=""bibr"" rid=""ref4"">4</xref>, <xref ref-type=""bibr"" rid=""ref5"">5</xref']","['Cortisol', 'daily plasma glucose concentrations', 'Caloric intake', 'Glucagon, insulin, and GLP-1', 'cortisol concentration', 'copeptin, glucose, insulin, glucagon, cortisol, and GLP-1 (Table 1', 'total urinary glucose output', 'glucoregulatory hormonal profiles', 'water intake on plasma glucose', 'urinary glucose output', 'daily glucose concentration', 'plasma osmolality, and copeptin', 'urine concentration and copeptin, a surrogate marker for AVP ']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3844106', 'cui_str': '800'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376344', 'cui_str': 'NHANES'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0039224', 'cui_str': 'Table'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429236', 'cui_str': 'Urinary glucose output'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0860721', 'cui_str': 'Plasma osmolality'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0086589', 'cui_str': 'Marker, Surrogate'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}]",7.0,0.0403443,"Cortisol was significantly higher in LWI as than in HWI (p = 0.009, Fig. 2); however, no pairwise differences were observed in post hoc analysis.","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Seal', 'Affiliation': 'Center for Health Research, California Polytechnic State University, San Luis Obispo, California, USA.'}, {'ForeName': 'Abigail T', 'Initials': 'AT', 'LastName': 'Colburn', 'Affiliation': 'Hydration Science Laboratory, Arizona State University, Phoenix, Arizona, USA.'}, {'ForeName': 'HyunGyu', 'Initials': 'H', 'LastName': 'Suh', 'Affiliation': 'Exercise Physiology Laboratory, Georgia Institute of Technology, Atlanta, Georgia, USA.'}, {'ForeName': 'Stavros A', 'Initials': 'SA', 'LastName': 'Kavouras', 'Affiliation': 'Hydration Science Laboratory, Arizona State University, Phoenix, Arizona, USA.'}]",Annals of nutrition & metabolism,['10.1159/000520479']
2815,35227311,The challenge of equipoise: qualitative interviews exploring the views of health professionals and women with multiple ipsilateral breast cancer on recruitment to a surgical randomised controlled feasibility trial.,"BACKGROUND


A multicentre feasibility trial (MIAMI), comparing outcomes and quality of life of women with multiple ipsilateral breast cancer randomised to therapeutic mammoplasty or mastectomy, was conducted from September 2018 to March 2020. The MIAMI surgical trial aimed to investigate recruitment of sufficient numbers of women. Multidisciplinary teams at 10 breast care centres in the UK identified 190 with MIBC diagnosis; 20 were eligible for trial participation but after being approached only four patients were recruited. A nested qualitative study sought to understand the reasons for this lack of recruitment.
METHODS


Interviews were conducted from November 2019 to September 2020 with 17 staff from eight hospital-based breast care centres that recruited and attempted to recruit to MIAMI; and seven patients from four centres, comprising all patients who were recruited to the trial and some who declined to take part. Interviews were audio-recorded, anonymised and analysed using thematic methods of building codes into themes and sub-themes using the process of constant comparison.
RESULTS


Overarching themes of (1) influences on equipoise and recruitment and (2) effects of a lack of equipoise were generated. Within these themes, health professional themes described the barriers to recruitment as 'the treatment landscape has changed', 'staff preferences and beliefs' which influenced equipoise and patient advice; and how different the treatments were for patients. Patient themes of 'altruism and timing of trial approach', 'influences from consultants and others' and 'diagnostic journey doubts' all played a part in whether patients agreed to take part in the trial.
CONCLUSIONS


Barriers to recruiting to breast cancer surgical trials can be significant, especially where there are substantial differences between the treatments being offered and a lack of equipoise communicated by healthcare professionals to patients. Patients can become overwhelmed by numerous requests for participation in research trials and inappropriate timing of trial discussions. Alternative study designs to the gold standard randomised control trial for surgical interventions may be required to provide the high-quality evidence on which to base practice.
TRIAL REGISTRATION


ISRCTN ( ISRCTN17987569 ) registered on April 20, 2018, and ClinicalTrials.gov ( NCT03514654 ).",2022,Multidisciplinary teams at 10 breast care centres in the UK identified 190 with MIBC diagnosis; 20 were eligible for trial participation but after being approached only four patients were recruited.,"['health professionals and women with multiple ipsilateral breast cancer', 'Interviews were conducted from November 2019 to September 2020 with 17 staff from eight hospital-based breast care centres that recruited and attempted to recruit to MIAMI; and seven patients from four centres, comprising all patients who were recruited to the trial and some who declined to take part', 'women with multiple ipsilateral breast cancer randomised to therapeutic mammoplasty or mastectomy, was conducted from September 2018 to March 2020', '10 breast care centres in the UK identified 190 with MIBC diagnosis; 20 were eligible for trial participation but after being approached only four patients were recruited']",[],[],"[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",[],[],4.0,0.230363,Multidisciplinary teams at 10 breast care centres in the UK identified 190 with MIBC diagnosis; 20 were eligible for trial participation but after being approached only four patients were recruited.,"[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ingram', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, BS8 1NU, UK. Jenny.Ingram@bristol.ac.uk.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Beasant', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, BS8 1NU, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Benson', 'Affiliation': 'Addenbrookes Hospital, Cambridge and School of Medicine Anglia Ruskin University, Cambridge, UK.'}, {'ForeName': 'Adrian Murray', 'Initials': 'AM', 'LastName': 'Brunt', 'Affiliation': 'School of Medicine, Keele University, Staffordshire, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Maxwell', 'Affiliation': 'Nightingale Centre, Wythenshawe Hospital, Manchester, UK.'}, {'ForeName': 'James Richard', 'Initials': 'JR', 'LastName': 'Harvey', 'Affiliation': 'Nightingale Centre, Wythenshawe Hospital, Manchester, UK.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Greenwood', 'Affiliation': 'University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Roberts', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, BS8 1NU, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Winters', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-022-01007-1']
2816,35227308,Adverse effects of delayed antimicrobial treatment and surgical source control in adults with sepsis: results of a planned secondary analysis of a cluster-randomized controlled trial.,"BACKGROUND


Timely antimicrobial treatment and source control are strongly recommended by sepsis guidelines, however, their impact on clinical outcomes is uncertain.
METHODS


We performed a planned secondary analysis of a cluster-randomized trial conducted from July 2011 to May 2015 including forty German hospitals. All adult patients with sepsis treated in the participating ICUs were included. Primary exposures were timing of antimicrobial therapy and delay of surgical source control during the first 48 h after sepsis onset. Primary endpoint was 28-day mortality. Mixed models were used to investigate the effects of timing while adjusting for confounders. The linearity of the effect was investigated by fractional polynomials and by categorizing of timing.
RESULTS


Analyses were based on 4792 patients receiving antimicrobial treatment and 1595 patients undergoing surgical source control. Fractional polynomial analysis identified a linear effect of timing of antimicrobials on 28-day mortality, which increased by 0.42% per hour delay (OR with 95% CI 1.019 [1.01, 1.028], p ≤ 0.001). This effect was significant in patients with and without shock (OR = 1.018 [1.008, 1.029] and 1.026 [1.01, 1.043], respectively). Using a categorized timing variable, there were no significant differences comparing treatment within 1 h versus 1-3 h, or 1 h versus 3-6 h. Delays of more than 6 h significantly increased mortality (OR = 1.41 [1.17, 1.69]). Delay in antimicrobials also increased risk of progression from severe sepsis to septic shock (OR per hour: 1.051 [1.022, 1.081], p ≤ 0.001). Time to surgical source control was significantly associated with decreased odds of successful source control (OR = 0.982 [0.971, 0.994], p = 0.003) and increased odds of death (OR = 1.011 [1.001, 1.021]; p = 0.03) in unadjusted analysis, but not when adjusted for confounders (OR = 0.991 [0.978, 1.005] and OR = 1.008 [0.997, 1.02], respectively). Only, among patients with septic shock delay of source control was significantly related to risk-of death (adjusted OR = 1.013 [1.001, 1.026], p = 0.04).
CONCLUSIONS


Our findings suggest that management of sepsis is time critical both for antimicrobial therapy and source control. Also patients, who are not yet in septic shock, profit from early anti-infective treatment since it can prevent further deterioration. Trial registration ClinicalTrials.gov ( NCT01187134 ). Registered 23 August 2010, NCT01187134.",2022,"Delay in antimicrobials also increased risk of progression from severe sepsis to septic shock (OR per hour: 1.051 [1.022, 1.081], p ≤ 0.001).","['All adult patients with sepsis treated in the participating ICUs were included', '4792 patients receiving antimicrobial treatment and 1595 patients undergoing surgical source control', 'July 2011 to May 2015 including forty German hospitals', 'adults with sepsis']",['delayed antimicrobial treatment and surgical source control'],"['odds of death', 'timing of antimicrobial therapy and delay of surgical source control', 'mortality', '28-day mortality', 'risk-of death', 'Adverse effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",4792.0,0.252307,"Delay in antimicrobials also increased risk of progression from severe sepsis to septic shock (OR per hour: 1.051 [1.022, 1.081], p ≤ 0.001).","[{'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Rüddel', 'Affiliation': 'Integrated Research and Treatment Center - Center for Sepsis Control and Care (CSCC), Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Daniel O', 'Initials': 'DO', 'LastName': 'Thomas-Rüddel', 'Affiliation': 'Integrated Research and Treatment Center - Center for Sepsis Control and Care (CSCC), Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Reinhart', 'Affiliation': 'Department of Anaesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.'}, {'ForeName': 'Friedhelm', 'Initials': 'F', 'LastName': 'Bach', 'Affiliation': 'Department for Infectious Diseases, Protestant Hospital of Bethel Foundation University Hospital, University of Bielefeld, Bethesdaweg 10, 33617, Bielefeld, Germany.'}, {'ForeName': 'Herwig', 'Initials': 'H', 'LastName': 'Gerlach', 'Affiliation': 'Department for Anaesthesia, Intensive Care Medicine and Pain Management, Vivantes - Klinikum Neukoelln, Rudower Strasse 48, 12351, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Lindner', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Arnold-Heller-Straße 3, 24105, Kiel, Germany.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Marshall', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, 209 Victoria St, Toronto, ON, M5B 1T8, Canada.""}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Centre, Liebigstraße 20, 04103, Leipzig, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Klinik Für Anästhesiologie Und Intensivmedizin, Universitätsklinikum Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Bloos', 'Affiliation': 'Integrated Research and Treatment Center - Center for Sepsis Control and Care (CSCC), Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schwarzkopf', 'Affiliation': 'Integrated Research and Treatment Center - Center for Sepsis Control and Care (CSCC), Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany. Daniel.Schwarzkopf@med.uni-jena.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Critical care (London, England)",['10.1186/s13054-022-03901-9']
2817,35227250,Feasibility of a fast-track randomized controlled trial of cell-free and concentrated ascites reinfusion therapy for patients with refractory malignant ascites.,"BACKGROUND


Malignant ascites often causes discomfort in advanced cancer patients. Paracentesis is the most common treatment modality, but it requires frequently repeated treatment. Cell-free and concentrated ascites reinfusion therapy (CART) may prolong the paracentesis interval, but controlled trials are lacking. We assessed the feasibility of a randomized controlled trial of CART vs. paracentesis alone for patients with refractory malignant ascites.
METHODS


This study was an open-label, fast-track, randomized controlled, feasibility trial. Patients admitted to four designated cancer hospitals who received no further anticancer treatments were eligible. Patients were randomly assigned 1:1 to a CART arm or control (simple paracentesis) arm. The feasibility endpoint was the percentage of patients who completed the study intervention. Secondary endpoints included paracentesis-free survival, patient's request on the questionnaire for paracentesis (PRO-paracentesis)-free survival (the period until the patients first reported that they would want paracentesis if indicated), and adverse events.
RESULTS


We screened 953 patients for eligibility. Of 61 patients with refractory malignant ascites, 21 patients were determined as eligible. Finally, 20 patients consented and were allocated; 18 patients (90%, 95% CI: 68.3-98.8) completed the study intervention. All patients had an ECOG performance status of 3 or 4. The median drained ascites volume was 3,200 mL in the CART arm and 2,500 mL in the control arm. In the CART arm, the median reinfused albumin volume was 12.6 g. Median paracentesis-free survivals were 5 days (95% CI: 2-6) in the CART arm, and 6 days (3-9) in the control arm. Median PRO-paracentesis-free survivals were 4 days (2-5) and 5 days (1-9), respectively. A total of 73% of patients received paracentesis within 2 days from their first request for the next paracentesis. One patient in the CART arm developed Grade 1 fever.
CONCLUSIONS


A fast-track randomized controlled trial of CART for patients with malignant ascites is feasible. The efficacy and safety of CART should be assessed in future trials. PRO-paracentesis-free survival may be a complementary outcome measure with paracentesis-free survival in future trials.
TRIAL REGISTRATION


Registered at University Hospital Medical Information Network Clinical Trial Registry as UMIN000031029 . Registered on 28/01/2018.",2022,"The median drained ascites volume was 3,200 mL in the CART arm and 2,500 mL in the control arm.","['All patients had an ECOG performance status of 3 or 4', '953 patients for eligibility', '20 patients consented and were allocated; 18 patients (90%, 95% CI: 68.3-98.8) completed the study intervention', 'Patients admitted to four designated cancer hospitals who received no further anticancer treatments were eligible', 'patients with malignant ascites', 'advanced cancer patients', 'patients with refractory malignant ascites', '61 patients with refractory malignant ascites, 21 patients were determined as eligible']","['CART vs. paracentesis alone', 'Cell-free and concentrated ascites reinfusion therapy (CART', 'CART', 'CART arm or control (simple paracentesis', 'cell-free and concentrated ascites reinfusion therapy']","['Grade 1 fever', 'median drained ascites volume', 'Median PRO-paracentesis-free survivals', 'adverse events', ""paracentesis-free survival, patient's request on the questionnaire for paracentesis (PRO-paracentesis)-free survival"", 'median reinfused albumin volume']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}]","[{'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0854643', 'cui_str': 'Reinfusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C3888573', 'cui_str': 'Cell-free and concentrated ascites reinfusion therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332153', 'cui_str': 'Requested by patient'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001924', 'cui_str': 'albumin'}]",21.0,0.273592,"The median drained ascites volume was 3,200 mL in the CART arm and 2,500 mL in the control arm.","[{'ForeName': 'Naosuke', 'Initials': 'N', 'LastName': 'Yokomichi', 'Affiliation': 'Division of Palliative and Supportive Care, Seirei Mikatahara General Hospital, 3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka, 433-8558, Japan. n-yokomichi@sis.seirei.or.jp.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Imai', 'Affiliation': 'Seirei Hospice, Seirei Mikatahara General Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Surgery, Nagoya Tokushukai General Hospital, Kasugai, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Horiki', 'Affiliation': 'Departments of Gastroenterology and Hepatology, Itami City Hospital, Itami, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Yamauchi', 'Affiliation': 'Seirei Hospice, Seirei Mikatahara General Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Miwa', 'Affiliation': 'Seirei Hospice, Seirei Mikatahara General Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': 'Seirei Hospice, Seirei Mikatahara General Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Uneno', 'Affiliation': 'Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Division of Medical Engineering, Seirei Mikatahara General Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Division of Medical Engineering, Seirei Mikatahara General Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Ichikawa', 'Affiliation': 'Division of Medical Engineering, Seirei Mikatahara General Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Morita', 'Affiliation': 'Division of Palliative and Supportive Care, Seirei Mikatahara General Hospital, 3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka, 433-8558, Japan.'}]",BMC cancer,['10.1186/s12885-022-09336-3']
2818,35227219,Comparison of two different uses of underbody forced-air warming blankets for the prevention of hypothermia in patients undergoing arthroscopic shoulder surgery: a prospective randomized study.,"BACKGROUND


Forced-air warming (FAW) is an effective method of preventing inadvertent perioperative hypothermia (IPH). However, its warming effects can be influenced by the style and position of the FAW blanket. This study aimed to compare the effects of underbody FAW blankets being placed under or over patients in preventing IPH.
METHODS


Patients (n=100) undergoing elective arthroscopic shoulder surgery in the lateral decubitus position were randomized into either under body (UB) group or the over body (OB) group (50 per group). The body temperature of the patients was recorded from baseline to the end of anesthesia. The incidences of postoperative hypothermia and shivering were also collected.
RESULTS


A steady decline in the body temperature was observed in both groups up to 60 minutes after the start of FAW. After 60 minutes of warming, the OB group showed a gradual increase in the body temperature. However, the body temperature still decreased in UB group until 75 minutes, with a low of 35.7℃ ± 0.4℃. Then the body temperature increased mildly and reached 35.8℃ ± 0.4℃ at 90 minutes. After 45 minutes of warming, the body temperature between the groups was significantly different (P < 0.05). The incidence of postoperative hypothermia in the UB group was significantly higher than that in the OB group (P = 0.023).
CONCLUSIONS


The body temperature was significantly better with the use of underbody FAW blankets placed over patients than with them placed under patients. However, there was not a clinically significant difference in body temperature. The incidence of postoperative hypothermia was much lower in the OB group. Therefore, placing underbody FAW blankets over patients is recommended for the prevention of IPH in patients undergoing arthroscopic shoulder surgery.
TRIAL REGISTRATION


This single-center, prospective, RCT has completed the registration of the Chinese Clinical Trial Center at 13/1/2021 with the registration number ChiCTR2100042071 . It was conducted from 14/1/2021 to 30/10/2021 as a single, blinded trial in Sichuan Provincial Orthopedic Hospital.",2022,"The incidence of postoperative hypothermia in the UB group was significantly higher than that in the OB group (P = 0.023).
","['Sichuan Provincial Orthopedic Hospital', 'Patients (n=100) undergoing elective arthroscopic shoulder surgery in the lateral decubitus position', 'patients undergoing arthroscopic shoulder surgery']","['underbody FAW blankets', 'Forced-air warming (FAW', 'underbody forced-air warming blankets', 'placing underbody FAW blankets', 'under body (UB) group or the over body (OB']","['incidence of postoperative hypothermia', 'body temperature still', 'body temperature', 'postoperative hypothermia', 'postoperative hypothermia and shivering']","[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0184351', 'cui_str': 'Warming blanket'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}]",100.0,0.0127998,"The incidence of postoperative hypothermia in the UB group was significantly higher than that in the OB group (P = 0.023).
","[{'ForeName': 'Wenchao', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': 'Department of Anesthesiology, Sichuan Provincial Orthopedic Hospital, No. 132 West First Section First Ring Road, Chengdu, 610041, Sichuan, China. yinwenchao2018@163.com.'}, {'ForeName': 'Qihai', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': 'Department of Anesthesiology, Sichuan Provincial Orthopedic Hospital, No. 132 West First Section First Ring Road, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Haibin', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Department of Anesthesiology, Sichuan Provincial Orthopedic Hospital, No. 132 West First Section First Ring Road, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Sichuan Provincial Orthopedic Hospital, No. 132 West First Section First Ring Road, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Chunqiong', 'Initials': 'C', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Sichuan Provincial Orthopedic Hospital, No. 132 West First Section First Ring Road, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Sichuan Provincial Orthopedic Hospital, No. 132 West First Section First Ring Road, Chengdu, 610041, Sichuan, China. zlzxm@163.com.'}]",BMC anesthesiology,['10.1186/s12871-022-01597-6']
2819,35230212,Improved adherence to clinical guidelines for low back pain after implementation of the BetterBack model of care: A stepped cluster randomized controlled trial within a hybrid type 2 trial.,"BACKGROUND


The BetterBack model of care (MoC) for low back pain (LBP) was recently developed in Swedish physiotherapy (PT) primary care.
OBJECTIVE


To evaluate if PTs' adherence to LBP clinical practice guidelines (CPGs) improves after implementation of the BetterBack MoC (intervention).
METHODS


This was a stepped, single-blinded cluster randomized controlled trial. Patients nested in the three clusters were allocated to routine care (n = 222) or intervention (n = 278). The primary outcome was referral to specialist consultation. This was among five best practice recommendations divided into an assessment quality index (no referral to specialist consultation and no medical imaging) and a treatment quality index (use of educational interventions; use of exercise interventions; no use of non-evidence-based physiotherapy). For overall adherence, patients had to be treated with all five recommendations fulfilled. Logistic regression was used for between-group comparisons.
RESULTS


The proportion of patients receiving referral to specialist consultation during the PT treatment period was low in both groups with no between-group differences. However, patients in the intervention group showed significantly higher assessment quality index, treatment quality index and overall adherence compared to routine care. Adherence to the separate recommendations showed improved stratified number of visits, use of exercise was maintained high, patient educational intervention increased and use of non-evidence-based physiotherapy decreased. A reduction of medical imaging during the physiotherapy treatment period was also observed.
CONCLUSIONS


The adoption of CPGs could be substantially improved by introducing a MoC through PT training and supportive materials.",2022,"However, patients in the intervention group showed significantly higher assessment quality index, treatment quality index and overall adherence compared to routine care.",['Patients nested in the three clusters were allocated to routine care (n\xa0=\xa0222) or intervention (n\xa0=\xa0278'],['exercise interventions; no use of non-evidence-based physiotherapy'],"['assessment quality index, treatment quality index and overall adherence', 'stratified number of visits, use of exercise', 'proportion of patients receiving referral to specialist consultation', 'referral to specialist consultation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C2090905', 'cui_str': 'Specialist consultation'}]",,0.0335467,"However, patients in the intervention group showed significantly higher assessment quality index, treatment quality index and overall adherence compared to routine care.","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Schröder', 'Affiliation': 'Unit of Physiotherapy, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Öberg', 'Affiliation': 'Unit of Physiotherapy, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Enthoven', 'Affiliation': 'Unit of Physiotherapy, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hedevik', 'Affiliation': 'Unit of Physiotherapy, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Abbott', 'Affiliation': 'Unit of Physiotherapy, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}]",Physiotherapy theory and practice,['10.1080/09593985.2022.2040669']
2820,35230203,What Kind of Therapy Works With Juveniles Who Have Sexually Offended? A Randomized-Controlled Trial of Two Versions of a Specialized Cognitive Behavioral Outpatient Treatment Program.,"There is ongoing debate about whether specialized treatment is effective to reduce sexual recidivism in juveniles who have sexually offended (JSOs). Although most treatment programs are based on cognitive behavioral therapy principles for preventing sexual offending, accordant scientific evidence is poor. Following CONSORT guidelines, the present study aimed to evaluate two versions of a short-term outpatient treatment program for JSOs in Switzerland: (a) the Therapy Program for Adequate Sexual Behaviors Version 1 (ThePaS-I), which included offending-specific skills training; (b) the ThePaS-II, which included general socioemotional skills training. Based on changes in self-reported mental health, sexual behaviors, victim empathy, and therapist-rated risk, as well as comprehensive data on sexual and general recidivism, we found some similarities regarding the effects of the two treatments. ThePaS-II showed better short-term changes in self-reported mental health than the ThePaS-I. However, JSOs in the ThePaS-I showed lower rates of sexual reoffending (but not general reoffending) after treatment than those in the ThePaS-II. Despite some methodological limitations, the current findings favor offending-specific skills-based therapy over general skills-based ones for preventing sexual reoffenses. The findings may encourage further methodologically sound studies to examine different treatment approaches for juveniles and adults who have committed criminal offenses.",2022,There is ongoing debate about whether specialized treatment is effective to reduce sexual recidivism in juveniles who have sexually offended (JSOs).,"['juveniles who have sexually offended (JSOs', 'juveniles and adults who have committed criminal offenses']","['ThePaS-II, which included general socioemotional skills training', 'Specialized Cognitive Behavioral Outpatient Treatment Program']","['ThePaS-II showed better short-term changes in self-reported mental health', 'rates of sexual reoffending']","[{'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",,0.0102924,There is ongoing debate about whether specialized treatment is effective to reduce sexual recidivism in juveniles who have sexually offended (JSOs).,"[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Aebi', 'Affiliation': 'Department of Justice and Home Affairs, Research & Development, Corrections and Rehabilitation, Canton of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Krause', 'Affiliation': 'Department of Forensic Psychiatry, Child and Adolescent Forensic Psychiatry, 363320University Hospital of Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Barra', 'Affiliation': 'Institute for Forensic Psychology and Psychiatry, Neurocenter - Saarland University Medical Center, Homburg/Saar, Homburg/Saar, Germany.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Vogt', 'Affiliation': 'Department of Justice and Home Affairs, Psychiatric-Psychological Services, Corrections and Rehabilitation, Canton of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Vertone', 'Affiliation': 'Department of Forensic Psychiatry, Child and Adolescent Forensic Psychiatry, 363320University Hospital of Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Madleina', 'Initials': 'M', 'LastName': 'Manetsch', 'Affiliation': 'Department of Forensic Child and Adolescent Psychiatry, Forensic Psychiatric Clinic, University Psychiatric Hospitals, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Imbach', 'Affiliation': 'Institute of Forensic Psychology, Lucerne, Switzerland.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Endrass', 'Affiliation': 'Department of Justice and Home Affairs, Research & Development, Corrections and Rehabilitation, Canton of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Rossegger', 'Affiliation': 'Department of Justice and Home Affairs, Research & Development, Corrections and Rehabilitation, Canton of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Schmeck', 'Affiliation': 'Child and Adolescent Psychiatric Research Department, Psychiatric University Hospitals, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Bessler', 'Affiliation': 'Department of Justice and Home Affairs, Research & Development, Corrections and Rehabilitation, Canton of Zurich, Zurich, Switzerland.'}]",Sexual abuse : a journal of research and treatment,['10.1177/10790632211070804']
2821,35230177,Remotely Educating Young Women About Alcohol: A Randomized Trial of the PartyWise Intervention.,"Background:  Alcohol and binge drinking pose significant health risks, especially for underage women; nonetheless, binge drinking is common.  Materials and Methods:  To evaluate the effectiveness of the PartyWise intervention in increasing awareness of sex differences in the risks of binge drinking, we used social media to enroll 520 female adolescents aged 15-19 years in a randomized controlled trial. Intervention participants received telephone screening, a brief counseling intervention with web-based resources (http://www.partywise.org), and up to 8 weekly text messages.  Results:  At baseline, most (71%) participants reported alcohol consumption in the prior month and 44% reported binge drinking (four or more drinks on one occasion), without differences between study groups; 79% of participants were aware of sex-based differences in alcohol risks. At follow-up, intervention recipients were more knowledgeable about sex-based differences in alcohol risks (adjusted odds ratio [adj OR] 8.87, 95% confidence interval [CI] 3.35-23.49 at 3 months; adj OR 2.44, 95% CI 1.21-4.90 at 9 months) and more likely to accurately define binge drinking (adj OR 1.63, 95% CI 1.02-2.60 at 3 months; OR 1.37, 95% CI 0.89-2.06 at 9 months). Although rates of any binge drinking in the past month remained similar between groups, intervention recipients were less likely to report binge drinking more than once in the past 30 days (22% vs. 32%, adj OR 0.58, 95% CI 0.35-0.99 at 3 months; 27% vs. 30%, adj OR 0.97, 95% CI 0.60-1.55 at 9 months).  Conclusions:  The PartyWise intervention is a promising approach to increasing awareness of the risks of binge drinking for underage women in a remotely delivered platform. Clinical Trials Registration: The Share Health Study: Teen Social Connections and Health (Phase 2), NCT03842540, https://clinicaltrials.gov/ct2/show/NCT03842540?id=NCT03842540&draw=2&rank=1.",2022,"At follow-up, intervention recipients were more knowledgeable about sex-based differences in alcohol risks (adjusted odds ratio [adj OR]","['520 female adolescents aged 15-19 years', 'Remotely Educating Young Women About Alcohol']","['telephone screening, a brief counseling intervention with web-based resources (http://www.partywise.org), and up to 8 weekly text messages', 'PartyWise intervention']","['rates of any binge drinking', 'alcohol risks', 'binge drinking', 'alcohol consumption', 'report binge drinking']","[{'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.151668,"At follow-up, intervention recipients were more knowledgeable about sex-based differences in alcohol risks (adjusted odds ratio [adj OR]","[{'ForeName': 'Eleanor Bimla', 'Initials': 'EB', 'LastName': 'Schwarz', 'Affiliation': 'Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Chatterton', 'Affiliation': 'Division of General Internal Medicine, University of California, Davis, Sacramento, California, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Fix', 'Affiliation': 'Center for Healthcare Policy and Research, University of California, Davis, Sacramento, California, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Tebb', 'Affiliation': ""Department of Pediatrics, Division of Adolescent and Young Adult Medicine, UCSF Benioff Children's Hospital, University of California, San Francisco, San Francisco, California, USA.""}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Rodriguez', 'Affiliation': ""Department of Pediatrics, Division of Adolescent and Young Adult Medicine, UCSF Benioff Children's Hospital, University of California, San Francisco, San Francisco, California, USA.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': 'Center for Healthcare Policy and Research, University of California, Davis, Sacramento, California, USA.'}, {'ForeName': 'Maneesha', 'Initials': 'M', 'LastName': 'Muriki', 'Affiliation': 'Center for Healthcare Policy and Research, University of California, Davis, Sacramento, California, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Satterfield', 'Affiliation': 'Division of General Internal Medicine at Mt Zion, University of California, San Francisco, San Francisco, California, USA.'}]",Journal of women's health (2002),['10.1089/jwh.2021.0285']
2822,35230162,Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide.,"Background:  Hypoactive sexual desire disorder (HSDD), the most prevalent female sexual dysfunction, is characterized as persistent diminished desire for sexual activity accompanied by distress. The efficacy and safety of bremelanotide, a melanocortin receptor agonist approved by the U.S. Food and Drug Administration for treatment of acquired generalized HSDD in premenopausal women, were established in the phase 3 RECONNECT studies, two identically designed double-blind randomized placebo-controlled studies with an optional 52-week open-label extension. This report investigates efficacy of bremelanotide versus placebo according to prespecified subgroups (age, weight, body mass index [BMI], and bioavailable testosterone) in the RECONNECT studies.  Methods:  Patients self-administered bremelanotide 1.75 mg or placebo subcutaneously using an autoinjector, as needed, before sexual activity for 24 weeks. Efficacy was assessed using change from baseline to end-of-study for Female Sexual Function Index desire domain and Female Sexual Distress Scale-Desire/Arousal/Orgasm Item 13 for bremelanotide versus placebo.  Results:  Among 1202 patients included in the integrated and subgroup analyses, bremelanotide achieved statistically significant improvements in measures of increased desire and decreased distress associated with low desire across all age, weight, and BMI subgroups, and all baseline bioavailable testosterone quartiles, with few exceptions. Bremelanotide was further associated with statistically significant increases in reported sexual desire ( p  < 0.05) in patients not taking hormonal contraceptives, and with a numerical advantage in those taking hormonal contraceptives. Patients treated with bremelanotide experienced decreased distress compared with those in the placebo group at levels of statistical significance ( p  < 0.05) regardless of hormonal contraceptive use. Statistically significant improvements were observed in the presence or absence of decreased arousal, and regardless of HSDD duration.  Conclusions:  Bremelanotide was associated with statistically significant improvements in sexual desire and reduced distress across several prespecified subgroups, with few exceptions.",2022,"Bremelanotide was further associated with statistically significant increases in reported sexual desire ( p  < 0.05) in patients not taking hormonal contraceptives, and with a numerical advantage in those taking hormonal contraceptives.","['premenopausal women', '1202 patients']","['bremelanotide 1.75\u2009mg or placebo', 'placebo', 'bremelanotide', 'bremelanotide versus placebo']","['distress', 'presence or absence of decreased arousal, and regardless of HSDD duration', 'sexual desire and reduced distress', 'Efficacy', 'sexual desire', 'increased desire and decreased distress', 'Female Sexual Function Index desire domain and Female Sexual Distress Scale-Desire/Arousal/Orgasm']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1721339', 'cui_str': 'bremelanotide'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}]",1202.0,0.0830866,"Bremelanotide was further associated with statistically significant increases in reported sexual desire ( p  < 0.05) in patients not taking hormonal contraceptives, and with a numerical advantage in those taking hormonal contraceptives.","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': 'George Washington University and IntimMedicine® Specialists, Inc., Washington, District of Columbia, USA.'}, {'ForeName': 'Sheryl A', 'Initials': 'SA', 'LastName': 'Kingsberg', 'Affiliation': 'Department of Reproductive Biology and Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Portman', 'Affiliation': 'Sermonix Pharmaceuticals, Columbus, Ohio, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jordan', 'Affiliation': 'Palatin Technologies, Inc., Cranbury, New Jersey, USA.'}, {'ForeName': 'Johna', 'Initials': 'J', 'LastName': 'Lucas', 'Affiliation': 'Palatin Technologies, Inc., Cranbury, New Jersey, USA.'}, {'ForeName': 'Amama', 'Initials': 'A', 'LastName': 'Sadiq', 'Affiliation': 'AMAG Pharmaceuticals, Inc., Waltham, Massachusetts, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Krop', 'Affiliation': 'AMAG Pharmaceuticals, Inc., Waltham, Massachusetts, USA.'}, {'ForeName': 'Anita H', 'Initials': 'AH', 'LastName': 'Clayton', 'Affiliation': 'Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, Virginia, USA.'}]",Journal of women's health (2002),['10.1089/jwh.2021.0225']
2823,35230143,"Commentary on ""Comparison of Multimodal Cocktail to Ropivacaine Intercostal Nerve Block for Chest Pain After Costal Cartilage Harvest: A Randomized Controlled Trial"" by Wenfang et al.",,2022,,[],"['Costal Cartilage Harvest', 'Ropivacaine Intercostal Nerve Block']",['Chest Pain'],[],"[{'cui': 'C0222787', 'cui_str': 'Structure of costal cartilage'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block'}]","[{'cui': 'C0008031', 'cui_str': 'Chest pain'}]",,0.234928,,"[{'ForeName': 'Dean M', 'Initials': 'DM', 'LastName': 'Toriumi', 'Affiliation': 'Department of Otolaryngology, Rush University Medical School, Chicago, Illinois, USA.'}]",Facial plastic surgery & aesthetic medicine,['10.1089/fpsam.2021.0410']
2824,35230585,Definitive results of a phase III adjuvant trial comparing six cycles of FEC-100 to four cycles of AC in women with operable node-negative breast cancer: the NSABP B-36 trial (NRG Oncology).,"PURPOSE


Results from adjuvant trials evaluating 6 cycles of epirubicin-based chemotherapy regimens suggested these programs may be more effective than 4 cycles of doxorubicin-based chemotherapy.
METHOD


NSABP B-36 was a phase III clinical trial originally designed as a 2 × 2 factorial study comparing 6 cycles of 5-FU, epirubicin, and cyclophosphamide (FEC-100) to 4 cycles of conventional doxorubicin and cyclophoshamide (AC) with celecoxib or placebo. Shortly after activation, concerns regarding increased cardiovascular risks among selective COX-2 inhibitors resulted in a decision to remove the celecoxib/placebo from the trial. Women with histologically node-negative invasive breast cancer who had undergone primary surgery with a lumpectomy or total mastectomy were eligible. Primary endpoint was disease-free survival (DFS).
RESULTS


Between May 2004 and July 2008, 2722 patients were enrolled. Administration of FEC-100 did not result in improvement in DFS compared to AC (HR 1.09; 95% CI 0.92-1.29, p value = 0.31). The effect of FEC-100 compared to AC on DFS was significantly different for receptor-positive (HR 1.32, 95% CI 1.05-1.66) compared to receptor-negative patients (HR 0.86, 95% CI 0.66-1.11) (treatment-by-receptor status interaction p value = 0.02). There was no statistically significant difference in the effect of treatment on overall survival (OS) with FEC-100 compared to AC (HR 1.06; 95% CI 0.84-1.35, p value = 0.61). Overall, Grade 3 and 4 adverse events were more frequent in the FEC-100 group.
CONCLUSION


The results of B-36 do not support use of six-cycle anthracycline-based regimens in node-negative breast cancer. Prolongation of anthracycline-based therapy with FEC-100 does not improve DFS or OS, relative to AC for 4 cycles, and was associated with expected increases in toxicity. A statistically significant interaction between treatment and hormone receptor status favoring AC in hormone-receptor-positive breast cancers is consistent with the hypothesis that optimal duration of chemotherapy may be four cycles in these patients. Late cardiac events and deaths prior to recurrence or second cancer were infrequent on both arms, but slightly higher with FEC-100.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT00087178.",2022,"Administration of FEC-100 did not result in improvement in DFS compared to AC (HR 1.09; 95% CI 0.92-1.29, p value = 0.31).","['Between May 2004 and July 2008, 2722 patients were enrolled', 'node-negative breast cancer', 'Women with histologically node-negative invasive breast cancer who had undergone primary surgery with a lumpectomy or total mastectomy were eligible', 'women with operable node-negative breast cancer', 'NSABP B-36 was a phase III clinical trial originally designed as a 2\u2009×\u20092 factorial study comparing 6 cycles of']","['celecoxib/placebo', 'FEC-100', '5-FU, epirubicin, and cyclophosphamide (FEC-100', 'conventional doxorubicin and cyclophoshamide (AC) with celecoxib or placebo', 'epirubicin-based chemotherapy', 'doxorubicin-based chemotherapy', 'anthracycline-based therapy with FEC-100']","['Overall, Grade 3 and 4 adverse events', 'cardiovascular risks', 'DFS or OS', 'overall survival (OS', 'toxicity', 'Late cardiac events and deaths prior to recurrence or second cancer', 'disease-free survival (DFS', 'DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0851238', 'cui_str': 'Lumpectomy of breast'}, {'cui': 'C0024886', 'cui_str': 'Simple mastectomy'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0636363', 'cui_str': 'As-A 2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0060133', 'cui_str': 'FEC protocol'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0751623', 'cui_str': 'Second primary malignancy'}]",2722.0,0.304041,"Administration of FEC-100 did not result in improvement in DFS compared to AC (HR 1.09; 95% CI 0.92-1.29, p value = 0.31).","[{'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA. charles.geyer@nsabp.org.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Bandos', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Jacobs', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Robidoux', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fehrenbacher', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Ward', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Polikoff', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Brufsky', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Provencher', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Alexander H G', 'Initials': 'AHG', 'LastName': 'Paterson', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Hamm', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Carolla', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Baez-Diaz', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Julian', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Swain', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Eleftherios P', 'Initials': 'EP', 'LastName': 'Mamounas', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NRG Oncology, Nova Tower 2, Two Allegheny Center, Suite 1245, Pittsburgh, PA, 15212, USA.'}]",Breast cancer research and treatment,['10.1007/s10549-021-06417-y']
2825,35230558,"Effects of changes in position, positive end-expiratory pressure and mean arterial pressure on renal, portal and hepatic Doppler ultrasound perfusion indices: a randomized crossover study in cardiac surgery patients.","Point-of-care ultrasound perfusion indices can be used for detection of AKI and venous congestion. Patients in the postoperative- and intensive care units are frequently exposed to alternating treatment and loading conditions. We aimed to study the effects of changes in preload (patient positioning), positive end-expiratory pressure (PEEP) and afterload (phenylephrine) on renal, portal and hepatic ultrasound indices. We hypothesized that renal resistive index was not influenced by changes in PEEP and patient positioning. This was a single-site, randomized, crossover study. Patients above 18 years scheduled for elective open-heart surgery at Aarhus University Hospital, Denmark, were available for inclusion. Patients were randomized to a sequence of six combinations of PEEP and position in addition to an increase in mean arterial pressure by phenylephrine. Thirty-one patients participated in the study. Resistive index was influenced by positional change (P = 0.007), but not by change in PEEP (P = 0.50) (Table 1). Renal venous stasis index and portal pulsatility fraction increased in the raised legs position (P ≤ 0.019), but not with increases in PEEP. Renal venous flow pattern and hepatic venous flow pattern were affected by position (P ≤ 0.019), but not by PEEP. None of the ultrasound indices were significantly changed by infusion of phenylephrine. Doppler perfusion indices were significantly affected by changes in preload, but not by changes in PEEP or afterload. Although the changes in the Doppler ultrasound indices were significant, they were small in absolute numbers. Therefore, from a clinical perspective, the ultrasound indices were robust.Trial registration Registered at clinicaltrials.com, first posted online June 5th 2020, identifier: NCT04419662.",2022,"Renal venous stasis index and portal pulsatility fraction increased in the raised legs position (P ≤ 0.019), but not with increases in PEEP.","['cardiac surgery patients', 'Patients above 18\xa0years scheduled for elective open-heart surgery at Aarhus University Hospital, Denmark, were available for inclusion', 'Thirty-one patients participated in the study']","['phenylephrine', 'preload (patient positioning), positive end-expiratory pressure', 'PEEP) and afterload (phenylephrine']","['Resistive index', 'position, positive end-expiratory pressure and mean arterial pressure on renal, portal and hepatic Doppler ultrasound perfusion indices', 'renal resistive index', 'mean arterial pressure', 'PEEP', 'Renal venous stasis index and portal pulsatility fraction', 'Renal venous flow pattern and hepatic venous flow pattern', 'renal, portal and hepatic ultrasound indices', 'Doppler perfusion indices']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C1561964', 'cui_str': 'Positioning patient'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C2964282', 'cui_str': 'Perfusion Index'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0577317', 'cui_str': 'Pulsatility'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0429874', 'cui_str': 'Venous flow'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0412534', 'cui_str': 'Ultrasonography of liver'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}]",31.0,0.0449174,"Renal venous stasis index and portal pulsatility fraction increased in the raised legs position (P ≤ 0.019), but not with increases in PEEP.","[{'ForeName': 'Johan L', 'Initials': 'JL', 'LastName': 'Hermansen', 'Affiliation': 'Department of Cardiothoracic- and Vascular Surgery, Anaesthesia Section, Aarhus University Hospital, Palle Juul-Jensens, Boulevard 99, 8200, Aarhus, Denmark. johanfhermansen@gmail.com.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Nørskov', 'Affiliation': 'Department of Cardiothoracic- and Vascular Surgery, Anaesthesia Section, Aarhus University Hospital, Palle Juul-Jensens, Boulevard 99, 8200, Aarhus, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Juhl-Olsen', 'Affiliation': 'Department of Cardiothoracic- and Vascular Surgery, Anaesthesia Section, Aarhus University Hospital, Palle Juul-Jensens, Boulevard 99, 8200, Aarhus, Denmark.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-022-00834-0']
2826,35230504,Prospective randomized trial of skin closure for pacemaker implantation: absorbable vs. non-absorbable suture : PRO-PACE.,"BACKGROUND


Pacemaker implantations have been performed for > 50 years, reaching 1.25 million implants worldwide per year. Despite this, only few randomized studies exist regarding technical aspects of the implantation procedure-in particular, wound closure. Accordingly, the authors compared absorbable vs. non-absorbable suture regarding wound healing.
METHODS


Consecutive patients scheduled for de novo pacemaker implantation without defibrillation therapy were prospectively randomized into two groups: non-absorbable (Prolene®, Ethicon Inc.) or absorbable suture (Monocryl®, Ethicon Inc.). The wound was systematically assessed for cosmetic outcome at 1 day, 6 weeks, and 1 year post implantation using the patient and observer scar assessment scale (POSAS). Adverse events noted included bleeding, pocket hematoma, infection, suture insufficiency, and revision surgery.
RESULTS


A total of 114 patients (mean age: 79 ± 10 years, n = 60 male) were randomized into the two groups. Of these, 105 completed follow-up (lost to follow-up: 7.9%). Groups were comparable for clinical characteristics or use of oral anticoagulants. There was no difference in cosmetic outcome and incidence of adverse events at any follow-up visit. POSAS scores were: 1 day: 1.4 ± 0.4 vs. 1.3 ± 0.4, P = 0.44, 6 weeks: 1.4 ± 0.6 vs. 1.4 ± 0.7, P = 0.57; 1 year: 1.4 ± 1.4 vs. 2.1 ± 3, P = 0.60. No pocket hematoma or infection occurred in either group. No additional surgery was necessary for local findings. Retrospectively, scar development was straight in the Prolene® group and slightly wavy with Monocryl®.
CONCLUSION


Suture material does not influence wound healing as represented by the cosmetic result and the occurrence of adverse events. The choice of suture material used should be left to the physician's discretion.",2022,There was no difference in cosmetic outcome and incidence of adverse events at any follow-up visit.,"['Consecutive patients scheduled for de novo pacemaker implantation without defibrillation therapy', '114\xa0patients (mean age: 79\u202f±\u200910\xa0years, n\u202f=\u200960 male']","['absorbable vs. non-absorbable suture', 'non-absorbable (Prolene®, Ethicon Inc.) or absorbable suture (Monocryl®, Ethicon Inc', 'pacemaker implantation: absorbable vs. non-absorbable suture : PRO-PACE', 'skin closure']","['POSAS scores', 'bleeding, pocket hematoma, infection, suture insufficiency, and revision surgery', 'wound healing', 'cosmetic outcome and incidence of adverse events', 'observer scar assessment scale (POSAS', 'pocket hematoma or infection', 'scar development']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0461628', 'cui_str': 'Non-absorbable suture'}, {'cui': 'C0917843', 'cui_str': 'Prolene'}, {'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0381197', 'cui_str': 'Monocryl'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",,0.0438832,There was no difference in cosmetic outcome and incidence of adverse events at any follow-up visit.,"[{'ForeName': 'Jaber', 'Initials': 'J', 'LastName': 'Abboud', 'Affiliation': 'St. Josefs-Hospital, Beethovenstr.\xa020, 65189, Wiesbaden, Germany.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Zezyk', 'Affiliation': 'St. Josefs-Hospital, Beethovenstr.\xa020, 65189, Wiesbaden, Germany.'}, {'ForeName': 'Andreas A', 'Initials': 'AA', 'LastName': 'Boehmer', 'Affiliation': 'St. Josefs-Hospital, Beethovenstr.\xa020, 65189, Wiesbaden, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Bork', 'Affiliation': 'St. Josefs-Hospital, Beethovenstr.\xa020, 65189, Wiesbaden, Germany.'}, {'ForeName': 'Bernhard M', 'Initials': 'BM', 'LastName': 'Kaess', 'Affiliation': 'St. Josefs-Hospital, Beethovenstr.\xa020, 65189, Wiesbaden, Germany.'}, {'ForeName': 'Joachim R', 'Initials': 'JR', 'LastName': 'Ehrlich', 'Affiliation': 'St. Josefs-Hospital, Beethovenstr.\xa020, 65189, Wiesbaden, Germany. jehrlich@joho.de.'}]",Herzschrittmachertherapie & Elektrophysiologie,['10.1007/s00399-022-00847-x']
2827,35230488,A phase 2a randomized vehicle-controlled multi-center study of the safety and efficacy of delgocitinib in subjects with moderate-to-severe alopecia areata.,"Alopecia areata/AA is an autoimmune cause of nonscarring hair loss. The pathogenesis of AA involves many immune axes, including Th1/Th2 pathways. Delgocitinib is a pan-Janus kinase/JAK inhibitor that broadly blocks pro-inflammatory cytokines and has been effective in other inflammatory skin conditions. Recent human studies/reports have shown that use of some systemic JAK inhibitors led to hair regrowth, suggesting this medication class as a potential therapy for AA. However, topical treatment is desirable due to potential systemic side effects. To assess the efficacy and safety of topical delgocitinib in AA, we conducted a double-blind, randomized, vehicle-controlled clinical trial in 31 moderate-to-severe AA patients that were randomized 2:1 to receive delgocitinib ointment 30 mg/g (n = 20) or ointment vehicle (n = 11) for 12 weeks. The primary endpoint was change in severity of Alopecia Tool/SALT score from baseline to week 12. The secondary endpoint included safety profile by reported adverse events. Twenty-three subjects completed the trial, with eight discontinuing mostly due to voluntary withdrawal. Ten patients receiving delgocitinib ointment and three patients receiving vehicle showed SALT score improvements after 12 weeks, but the mean percent SALT improvement at week 12 compared to baseline between the two arms was not significant (p = 0.92). Our study suggests that delgocitinib ointment is not effective in moderate-to-severe AA, likely due to its inability to penetrate sufficiently deeply into the dermis of the scalp, but larger studies are necessary to assess whether a different formulation of topical JAK inhibitors may be suitable to treat mild or more localized forms of AA.",2022,"Ten patients receiving delgocitinib ointment and three patients receiving vehicle showed SALT score improvements after 12 weeks, but the mean percent SALT improvement at week 12 compared to baseline between the two arms was not significant (p = 0.92).","['Twenty-three subjects completed the trial, with eight discontinuing mostly due to voluntary withdrawal', '31 moderate-to-severe AA patients', 'subjects with moderate-to-severe alopecia areata']","['delgocitinib ointment', 'topical delgocitinib', 'delgocitinib', 'delgocitinib ointment 30\xa0mg/g (n\u2009=\u200920) or ointment vehicle']","['mean percent SALT improvement', 'efficacy and safety', 'SALT score improvements', 'Alopecia areata/AA', 'safety profile by reported adverse events', 'severity of Alopecia Tool/SALT score']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]",31.0,0.488899,"Ten patients receiving delgocitinib ointment and three patients receiving vehicle showed SALT score improvements after 12 weeks, but the mean percent SALT improvement at week 12 compared to baseline between the two arms was not significant (p = 0.92).","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Mikhaylov', 'Affiliation': 'Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jacob W', 'Initials': 'JW', 'LastName': 'Glickman', 'Affiliation': 'Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Del Duca', 'Affiliation': 'Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nia', 'Affiliation': 'Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hashim', 'Affiliation': 'Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Singer', 'Affiliation': 'Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Alba L', 'Initials': 'AL', 'LastName': 'Posligua', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Aleksandra G', 'Initials': 'AG', 'LastName': 'Florek', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Ibler', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Erika L', 'Initials': 'EL', 'LastName': 'Hagstrom', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Yeriel', 'Initials': 'Y', 'LastName': 'Estrada', 'Affiliation': 'Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Rangel', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Colavincenzo', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA. emma.guttman@mountsinai.org.'}]",Archives of dermatological research,['10.1007/s00403-022-02336-0']
2828,33191181,Influence of everolimus-based treatment on circulating regulatory T cells after liver transplantation: Comparative study with tacrolimus-based therapy.,"Liver transplantation remains the only treatment for terminal liver diseases. However, immunosuppressive drugs required for allograft acceptance are toxic and may be responsible for severe side effects. Modulating the immune system to induce tolerance is a promising approach to reduce immunosuppressive regimen. More particularly, promoting natural CD4 +  CD25 +  FoxP3 +  Tregs could be crucial in achieving tolerance. Contrary to calcineurin inhibitors, reports indicate that mTOR inhibitors may have a positive impact on Tregs. Here we present the first randomized prospective clinical study where Tregs levels from liver transplanted patients receiving either tacrolimus or everolimus were monitored for 6 months, starting from the day of transplantation. A total of 30 patients from four centers were monitored. Blood samples were obtained at day 0, day 14, one month, three months and six months post-transplantation. Flow-cytometry immunophenotyping of Tregs (CD4 +  CD25 +  CD127 -  FoxP3 + ) and functional assays with Tregs were performed to assess their immunosuppressive capacity. Levels of Tregs were significantly reduced after one month of standard tacrolimus-based immunosuppressive regimen (p<0.05). Four months after conversion, levels of Tregs from patients treated with everolimus was significantly higher than patients under tacrolimus (p<0.02). Functional assays demonstrated that Tregs conserved their capacity to suppress the proliferation of activated PBMC.",2021,"Four months after conversion, levels of Tregs from patients treated with everolimus was significantly higher than patients under tacrolimus (p<0.02).","['after liver transplantation', '30 patients from four centers were monitored', 'liver transplanted patients receiving either']","['tacrolimus-based therapy', 'everolimus-based treatment', 'tacrolimus or everolimus']","['levels of Tregs', 'Levels of Tregs', 'Blood samples', 'circulating regulatory T cells']","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}]",30.0,0.0194422,"Four months after conversion, levels of Tregs from patients treated with everolimus was significantly higher than patients under tacrolimus (p<0.02).","[{'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Barjon', 'Affiliation': 'UMR_S 938, CDR Saint-Antoine, F-75012 Paris, France; De Duve Institute, UCLouvain, 1200 Brussels, Belgium.'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Dahlqvist', 'Affiliation': 'UMR_S 938, CDR Saint-Antoine, F-75012 Paris, France; Hepatogastroenterology Unit, Cliniques Universitaires Saint-Luc, Brussels, Belgium. Electronic address: geraldine.dahlqvist@uclouvain.be.'}, {'ForeName': 'Khaldoun', 'Initials': 'K', 'LastName': 'Ghazal', 'Affiliation': 'UMR_S 938, CDR Saint-Antoine, F-75012 Paris, France.'}, {'ForeName': 'Faouzi', 'Initials': 'F', 'LastName': 'Saliba', 'Affiliation': 'Centre Hépato-Biliaire, Hôpital Paul Brousse, AP-HP, Villejuif, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Durand', 'Affiliation': 'Liver Intensive Care Unit, Hôpital Beaujon, Assistance Publique-Hopitaux de Paris and University of Paris, Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Duvoux', 'Affiliation': 'Department of Hepatology, Hôpital Henri Mondor, AP-HP, Créteil, France.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Aoudjehane', 'Affiliation': 'UMR_S 938, CDR Saint-Antoine, F-75012 Paris, France.'}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Conti', 'Affiliation': 'UMR_S 938, CDR Saint-Antoine, F-75012 Paris, France; Liver Transplantation Unit, AP-HP, Hôpital de la Pitié-Salpêtrière, 75012 Paris, France.'}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2020.10.004']
2829,34252901,Effects of Orthokeratology on Axial Length Elongation in Anisometropes.,"INTRODUCTION


This study aimed to investigate the therapeutic effects of overnight orthokeratology (OK) lenses on anisometropes.
METHODS


We enrolled 178 anisometropes from August 2015 to August 2017. We then divided these patients into 2 parts depending on them wearing either monocular or binocular OK lenses. In part one, 47 monocular myopic subjects (25 males and 22 females) were treated with OK lenses in the myopic eyes only. We also labeled the myopic eyes as the OK group and the contralateral nonmyopic eyes as the control group. The initial average wearing age of the subjects was 12.35 ± 2.37 years (8-16 years). The mean follow-up duration was 15.43 ± 4.88 months (7-25 months). The average spherical equivalent refraction (SER) was -2.31 ± 1.16 diopter (D) in the OK group and 0.15 ± 0.49 D in the control group (p < 0.001). In part 2, 131 binocular myopic anisometropes (56 males and 75 females) were involved in the study. The eyes with more severe myopia were assigned to the G group and the contralateral eyes to the L group. The initial average wearing age of the subjects was 12.92 ± 2.60 years ( 8-16 years). The mean follow-up duration was 17.83 ± 5.02 months (7-26 months). The average SER was -4.79 ± 1.90 D in the G group and -3.14 ± 1.88 D in the L group (p < 0.001). We calculated the axial length (AL) difference and AL elongation as our primary outcome measures.
RESULTS


In part one, the AL elongation in the OK group (0.21 ± 0.09 mm) was significantly lower than that in the control group (0.70 ± 0.17 mm) at 24 months (p < 0.001). Meanwhile, the AL difference exhibited a decrease of 0.50 ± 0.29 mm from a baseline of 1.08 ± 0.35 to 0.58 ± 0.25 mm at 24 months (F = 24.539, p < 0.001). In part 2, the AL had increased by 0.17 ± 0.13 mm in the G group and 0.24 ± 0.18 mm in the L group after 24-month follow-up, respectively (p < 0.001). While the AL difference decreased from 0.55 ± 0.11 mm at the baseline, to 0.48 ± 0.08 mm at 24 months, eliciting a decrement in AL difference of 0.07 ± 0.09 mm (F = 3.884, p = 0.030).
CONCLUSIONS


OK lenses can slow down AL growth in anisometropes and has a greater effect on reducing AL elongation in the more severely affected myopic eyes of anisometropic patients.",2021,The average spherical equivalent refraction (SER) was -2.31 ± 1.16 diopter (D) in the OK group and 0.15 ± 0.49 D in the control group (p < 0.001).,"['eyes with more severe myopia', 'We enrolled 178 anisometropes from August 2015 to August 2017', 'Anisometropes', 'In part 2, 131 binocular myopic anisometropes (56 males and 75 females', '47 monocular myopic subjects (25 males and 22 females']","['OK lenses', 'Orthokeratology', 'overnight orthokeratology (OK) lenses', 'wearing either monocular or binocular OK lenses']","['average spherical equivalent refraction (SER', 'average SER', 'Axial Length Elongation', 'axial length (AL) difference and AL elongation']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271183', 'cui_str': 'Severe myopia'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}]","[{'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",178.0,0.0822069,The average spherical equivalent refraction (SER) was -2.31 ± 1.16 diopter (D) in the OK group and 0.15 ± 0.49 D in the control group (p < 0.001).,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Shandong University of Traditional Chinese Medicine (TCM), Jinan, China, xj940616@163.com.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Gao', 'Affiliation': 'Shandong University of Traditional Chinese Medicine (TCM), Jinan, China.'}, {'ForeName': 'Qingmei', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': 'Affiliated Eye Hospital of Shandong University of TCM, Jinan, China.'}, {'ForeName': 'Qiuxin', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Affiliated Eye Hospital of Shandong University of TCM, Jinan, China.'}, {'ForeName': 'Xiuyan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Affiliated Eye Hospital of Shandong University of TCM, Jinan, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Shandong University of Traditional Chinese Medicine (TCM), Jinan, China.'}, {'ForeName': 'Ruixue', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Shandong University of Traditional Chinese Medicine (TCM), Jinan, China.'}, {'ForeName': 'Jike', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Shandong University of Traditional Chinese Medicine (TCM), Jinan, China.'}, {'ForeName': 'Hongsheng', 'Initials': 'H', 'LastName': 'Bi', 'Affiliation': 'Affiliated Eye Hospital of Shandong University of TCM, Jinan, China.'}]",Ophthalmic research,['10.1159/000516907']
2830,35227365,What Influences the Credibility of Printed Nutrition Education Materials?,"Objectives:  In this study, we aimed to determine the influence of aesthetics and color of printed nutrition education materials on perceived credibility of the material content.  Methods:  A randomized 2 x 2 (aesthetics and color) factorial experimental design was completed on a university campus. Undergraduate and graduate students (N=204) were randomly assigned one of 4 types of flyers (high aesthetic-color, high aesthetic-black-and-white, low aesthetic-color, and low aesthetic-black-and-white). Perceptions on the flyer content (accurate, believable, biased, valuable, and trustworthy), perceptions of overall flyer quality (attractive, pleasant, confusing, and interesting), and knowledge of the content within the flyer were assessed via a survey after reading the flyer.  Results:  A statistically significant main effect of aesthetics was observed for perceived ""trustworthiness"" of the flyer information (p = .048). Flyers with high aesthetics, regardless of print color, had a higher mean score of ""trustworthiness"" (M = 6.01) than flyers with low aesthetics (M = 5.71). An interaction effect was seen for perception of the flyer being ""confusing"" (p = .02). The high aesthetic-black-and-white flyer had the highest mean score for ""confusing"" (M = 1.66) with the low aesthetic flyer printed in color having the second highest mean score for ""confusing"" (M = 1.56).  Conclusions:  The aesthetics of nutrition education materials appear to influence perceived trustworthiness of those materials.",2022,"An interaction effect was seen for perception of the flyer being ""confusing"" (p = .02).",['Undergraduate and graduate students (N=204'],"['aesthetics and color of printed nutrition education materials', 'flyers (high aesthetic-color, high aesthetic-black-and-white, low aesthetic-color, and low aesthetic-black-and-white']","['aesthetics', 'flyer content (accurate, believable, biased, valuable, and trustworthy), perceptions of overall flyer quality (attractive, pleasant, confusing, and interesting), and knowledge of the content within the flyer']","[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",204.0,0.0405097,"An interaction effect was seen for perception of the flyer being ""confusing"" (p = .02).","[{'ForeName': 'Cori', 'Initials': 'C', 'LastName': 'Lorts', 'Affiliation': 'Cori Lorts, Assistant Professor, Northern Arizona University, Flagstaff, AZ, United States;, Email: Cori.Lorts@nau.edu.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Adams', 'Affiliation': 'Marc Adams, Associate Professor, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Roberto', 'Affiliation': 'Anthony J. Roberto, Professor, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Punam', 'Initials': 'P', 'LastName': 'Ohri-Vachaspati', 'Affiliation': 'Punam Ohri-Vachaspati, Professor, Arizona State University, Phoenix, AZ, United States.'}]",American journal of health behavior,['10.5993/AJHB.46.1.1']
2831,35227342,"Efficacy of a transdiagnostic, prevention-focused program for at-risk young adults: a waitlist-controlled trial.","BACKGROUND


Prevention programs that are 'transdiagnostic' may be more cost-effective and beneficial, in terms of reducing levels of psychopathology in the general population, than those focused on a specific disorder. This randomized controlled study evaluated the efficacy of one such intervention program called Resilience Training (RT).
METHODS


College students who reported mildly elevated depressive or subclinical psychotic symptoms ('psychotic experiences' (PEs)) (n = 107) were randomized to receiving RT (n = 54) or to a waitlist control condition (n = 53). RT consists of a four-session intervention focused on improving resilience through the acquisition of mindfulness, self-compassion, and mentalization skills. Measures of symptoms and these resilience-enhancing skills were collected before and after the 4-week RT/waitlist period, with a follow-up assessment 12-months later.
RESULTS


Compared to the waitlist control group, RT participants reported significantly greater reductions in PEs, distress associated with PEs, depression, and anxiety, as well as significantly greater improvements in resilience, mindfulness, self-compassion, and positive affect, following the 4-week RT/waitlist period (all p < 0.03). Moreover, improvements in resilience-promoting skills were significantly correlated with symptom reductions (all p < 0.05). Lastly, the RT-related reductions in PEs and associated distress were maintained at the 12-month follow-up assessment.
CONCLUSIONS


RT is a brief, group-based intervention associated with improved resilience and reduced symptoms of psychopathology, with sustained effects on PEs, in transdiagnostically at-risk young adults. Follow-up studies can further assess the efficacy of RT relative to other interventions and test whether it can reduce the likelihood of developing a serious mental illness.",2022,"Compared to the waitlist control group, RT participants reported significantly greater reductions in PEs, distress associated with PEs, depression, and anxiety, as well as significantly greater improvements in resilience, mindfulness, self-compassion, and positive affect, following the 4-week RT/waitlist period (all p < 0.03).","['at-risk young adults', ""College students who reported mildly elevated depressive or subclinical psychotic symptoms ('psychotic experiences' (PEs)) (n = 107""]","['waitlist control condition', 'intervention program called Resilience Training (RT', 'transdiagnostic, prevention-focused program for', 'RT']","['PEs and associated distress', 'PEs, distress associated with PEs, depression, and anxiety', 'resilience-promoting skills', 'resilience, mindfulness, self-compassion, and positive affect']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",107.0,0.0142698,"Compared to the waitlist control group, RT participants reported significantly greater reductions in PEs, distress associated with PEs, depression, and anxiety, as well as significantly greater improvements in resilience, mindfulness, self-compassion, and positive affect, following the 4-week RT/waitlist period (all p < 0.03).","[{'ForeName': 'Nicole R', 'Initials': 'NR', 'LastName': 'DeTore', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Luther', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Wisteria', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Logan', 'Initials': 'L', 'LastName': 'Leathem', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Burke', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Maren B', 'Initials': 'MB', 'LastName': 'Nyer', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Daphne J', 'Initials': 'DJ', 'LastName': 'Holt', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}]",Psychological medicine,['10.1017/S0033291722000046']
2832,35227323,Glycemic index and glycemic load of common fruit juices in Thailand.,"BACKGROUND


The glycemic index (GI) reflects body responses to different carbohydrate-rich foods. Generally, it cannot be simply predicted from the composition of the food but needs in vivo testing.
METHODS


Healthy adult volunteers with normal body mass index were recruited. Each volunteer was asked to participate in the study center twice in the first week to consume the reference glucose (50 g) and once a week thereafter to consume the study fruit juices in a random order. The study fruit juices were Florida orange juice, Tangerine orange juice, Blackcurrant mixed juice, and Veggie V9 orange carrot juice which were already available on the market. The serving size of each fruit juice was calculated to provide 50 g of glycemic carbohydrate. The fasting and subsequent venous blood samplings were obtained through the indwelling venous catheters at 0, 15, 30, 45, 60, 90, and 120 min after the test drink consumption and immediately sent for plasma glucose and insulin. GI and insulin indices were calculated from the incremental area under the curve of postprandial glucose of the test drink divided by the reference drink. Glycemic load (GL) was calculated from the GI multiplied by carbohydrate content in the serving size.
RESULTS


A total of 12 volunteers participated in the study. Plasma glucose and insulin peaked at 30 min after the drink was consumed, and then started to decline at 120 min. Tangerine orange juice had the lowest GI (34.1 ± 18.7) and GL (8.1 g). Veggie V9 had the highest GI (69.6 ± 43.3) but it was in the third GL rank (12.4 g). The insulin responses correlated well with the GI. Fructose to glucose ratio was inversely associated with GI and insulin responses for all study fruit juices. Fiber contents in the study juices did not correlate with glycemic and insulin indices.
CONCLUSIONS


The GIs of fruit juices were varied but consistently showed a positive correlation with insulin indices. Fruit juices with low GI are a healthier choice for people with diabetes as well as individuals who want to stay healthy since it produces more subtle postprandial glucose and insulin responses.",2022,Tangerine orange juice had the lowest GI (34.1 ± 18.7) and GL (8.1 g).,"['Healthy adult volunteers with normal body mass index were recruited', 'of common fruit juices in Thailand', '12 volunteers participated in the study']",['Fruit juices with low GI'],"['GI and insulin indices', 'insulin responses', 'GIs of fruit juices', 'Plasma glucose and insulin', 'Glycemic load (GL', 'Fructose to glucose ratio', 'glycemic and insulin indices', 'fasting and subsequent venous blood samplings', 'Glycemic index and glycemic load']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0231253', 'cui_str': 'Normal body mass index'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0452453', 'cui_str': 'Fruit juice'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0452453', 'cui_str': 'Fruit juice'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}]","[{'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0815319', 'cui_str': 'Geographical Information Systems'}, {'cui': 'C0452453', 'cui_str': 'Fruit juice'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C4042927', 'cui_str': 'Glycemic Load'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}]",12.0,0.0755002,Tangerine orange juice had the lowest GI (34.1 ± 18.7) and GL (8.1 g).,"[{'ForeName': 'Chonnikant', 'Initials': 'C', 'LastName': 'Visuthranukul', 'Affiliation': 'Pediatric Nutrition Research Unit, Division of Nutrition, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Pichet', 'Initials': 'P', 'LastName': 'Sampatanukul', 'Affiliation': 'Department of Pathology, Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Suphab', 'Initials': 'S', 'LastName': 'Aroonparkmongkol', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Bangkok, 10330, Thailand.'}, {'ForeName': 'Pathama', 'Initials': 'P', 'LastName': 'Sirimongkol', 'Affiliation': 'Division of Nutrition, Department of Pediatrics, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Bangkok, 10330, Thailand.'}, {'ForeName': 'Sirinuch', 'Initials': 'S', 'LastName': 'Chomtho', 'Affiliation': 'Pediatric Nutrition Research Unit, Division of Nutrition, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand. sirinuch.c@chula.ac.th.'}]","Journal of health, population, and nutrition",['10.1186/s41043-022-00284-z']
2833,35227313,Effect of a fixed-dose combination of Telmisartan/S-amlodipine on circadian blood pressure compared with Telmisartan monotherapy: TENUVA-BP study.,"BACKGROUND


This study evaluated the circadian efficacy of a telmisartan 40 mg/S-amlodipine 2.5 mg fixed-dose combination (Telmisartan40/S-Amlodipine2.5) compared to telmisartan 80 mg (Telmisartan80) in patients with essential hypertension who did not respond to 2-4 weeks' treatment with telmisartan 40 mg.
METHODS


Eligible patients with essential hypertension (clinic mean sitting systolic blood pressure [MSSBP] ≥140 mmHg, or ≥ 130 mmHg in those with diabetes mellitus or chronic kidney disease) were randomly assigned to Telmisartan40/S-Amlodipine2.5 or Telmisartan80 for 8 weeks. All patients underwent ambulatory BP monitoring (ABPM) at baseline and 8 weeks later. Primary endpoints were changes in mean 24-h SBP and DBP on 24-h ABPM from baseline after 8 weeks. Secondary endpoints were changes in daytime, nighttime, and morning SBP and DBP, and clinic MSSBP and MSDBP.
RESULTS


A total of 316 Korean patients were enrolled, 217 patients were randomized to treatment, and 192 patients completed the study. Compared to Telmisartan80, Telmisartan40/S-Amlodipine2.5 showed significantly better reductions in 24-h mean SBP and DBP after 8 weeks. Telmisartan40/S-Amlodipine2.5 also significantly reduced secondary endpoints compared to Telmisartan80. Among 15 adverse events (7 [Telmisartan40/S-Amlodipine2.5] and 8 [Telmisartan80]), there were five adverse drug reactions; 14 events were mild, and none were identified with significant between-group differences.
CONCLUSIONS


Telmisartan40/S-Amlodipine2.5 was tolerable and more effective than Telmisartan80 in lowering 24-h mean ambulatory BP in patients with essential hypertension not responding adequately to Telmisartan40. Our findings support the fact that the combination of S-amlodipine with telmisartan is more appropriate than increasing the dose of telmisartan monotherapy.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT02231788 . Registered 4 September 2014.",2022,Telmisartan40/S-Amlodipine2.5 also significantly reduced secondary endpoints compared to Telmisartan80.,"['patients with essential hypertension', ""patients with essential hypertension who did not respond to 2-4\u2009weeks' treatment with"", '316 Korean patients were enrolled, 217 patients were randomized to treatment, and 192 patients completed the study', 'mmHg in those with diabetes mellitus or chronic kidney disease', 'Eligible patients with essential hypertension (clinic mean sitting systolic blood pressure [MSSBP] ≥140\u2009mmHg, or\u2009≥\u2009130']","['telmisartan 40\u2009mg', 'Telmisartan/S-amlodipine', 'telmisartan 80\u2009mg (Telmisartan80', 'telmisartan 40\u2009mg/S-amlodipine 2.5\u2009mg fixed-dose combination (Telmisartan40/S-Amlodipine2.5', 'amlodipine with telmisartan', 'ambulatory BP monitoring (ABPM']","['mean 24-h SBP and DBP on 24-h ABPM', 'circadian blood pressure', 'changes in daytime, nighttime, and morning SBP and DBP, and clinic MSSBP and MSDBP', 'circadian efficacy', '24-h mean SBP and DBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1319893', 'cui_str': 'Sitting systolic blood pressure'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0990502', 'cui_str': 'telmisartan 40 MG'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0990503', 'cui_str': 'telmisartan 80 MG'}, {'cui': 'C1124795', 'cui_str': 'Amlodipine 2.5 MG'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",316.0,0.0495298,Telmisartan40/S-Amlodipine2.5 also significantly reduced secondary endpoints compared to Telmisartan80.,"[{'ForeName': 'Bong-Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kosin University College of Medicine, Gospel Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Kyoung-Im', 'Initials': 'KI', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kosin University College of Medicine, Gospel Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Hyuck Moon', 'Initials': 'HM', 'LastName': 'Kwon', 'Affiliation': 'Cardiology Division, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Min', 'Initials': 'SM', 'LastName': 'Choi', 'Affiliation': 'Department of Cardiology, National Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Chang-Hwan', 'Initials': 'CH', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Sang Wook', 'Initials': 'SW', 'LastName': 'Lim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Seung-Jae', 'Initials': 'SJ', 'LastName': 'Joo', 'Affiliation': 'Department of Internal Medicine, Jeju National University Hospital, Jeju, Republic of Korea.'}, {'ForeName': 'Nam Ho', 'Initials': 'NH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Yup', 'Initials': 'SY', 'LastName': 'Lim', 'Affiliation': 'Department of Cardiology, Korea University Ansan Hospital, Ansan, Republic of Korea.'}, {'ForeName': 'Seong-Hoon', 'Initials': 'SH', 'LastName': 'Lim', 'Affiliation': 'Cardiovascular Division, Department of Internal Medicine, Dankook University Hospital, Cheonan, Republic of Korea.'}, {'ForeName': 'Hyo-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. usahyosoo@gmail.com.'}]",Clinical hypertension,['10.1186/s40885-021-00184-0']
2834,35227197,Effectiveness of the advisory display SmartPilot® view in the assessment of anesthetic depth in low risk gynecological surgery patients: a randomized controlled trial.,"BACKGROUND


Assessment of appropriate anesthetic depth is crucial to prevent harm to patients. Unnecessary deep anesthesia can be harmful, potentially causing acute renal failure, myocardial injury, delirium, and an increased mortality rate. Conversely, too light anesthesia combined with muscle relaxants can result in intraoperative patient awareness and lead to serious psychological trauma. This trial aimed to ascertain the effectiveness of the advisory display SmartPilot® View (SPV), as a supplemental measure in the assessment of anesthetic depth in low risk gynecological surgery patients. The hypothesis was that the use of the SPV would increase the precision of assessment, and result in a higher mean arterial pressure.
METHODS


This trial used a randomized, controlled, single-blind design with a homogeneous sample. Patients undergoing minor, low risk gynecological surgery were randomly assigned to two groups: a test group wherein current standards were supplemented with the advisory display SPV and a control group assessed using only the current standards. Female patients aged between 18 and 75 years with American Society of Anesthesiologists Physical Status Classification System scores of 1-3 undergoing planned general anesthesia using the total intravenous anesthetic method, combining propofol and remifentanil, were included. The exclusion criteria included a body mass index ≥ 35 kg/m 2 , a history of alcoholism, drug intake affecting propofol and remifentanil dynamics, and inability to consent. The independent sample t-test and chi-square test or Fisher's exact test were used to assess the statistical significance of differences between the two groups.
RESULTS


A total of 114 patients were included in the analysis (test group n = 58, control group n = 56). No significant differences in the mean arterial pressure, heart rate, bispectral index, extubation delay, or post-anesthesia care unit stay were found between groups.
CONCLUSIONS


The addition of the advisory display SmartPilot® View to current standards in the evaluation of anesthetic depth had no significant effect on the outcome.
TRIAL REGISTRATION


The trial was registered on January 16th 2019 with ClinicalTrials.gov (ref: NCT03807271 ).",2022,"No significant differences in the mean arterial pressure, heart rate, bispectral index, extubation delay, or post-anesthesia care unit stay were found between groups.
","['low risk gynecological surgery patients', 'Patients undergoing minor,\xa0low risk gynecological surgery', 'Female patients aged between 18 and 75 years with American Society of Anesthesiologists Physical Status Classification System scores of 1-3 undergoing planned general anesthesia using the total intravenous anesthetic method, combining', 'A total of 114 patients were included in the analysis (test group n\u2009=\u200958, control group n\u2009=\u200956']","['advisory display SmartPilot® View (SPV', 'propofol and remifentanil', 'light anesthesia combined with muscle relaxants', 'test group wherein current standards were supplemented with the advisory display SPV and a control group assessed using only the current standards', 'advisory display SmartPilot® view']","['mean arterial pressure, heart rate, bispectral index, extubation delay, or post-anesthesia care unit stay', 'mortality rate']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450990', 'cui_str': 'American Society of Anesthesiologists physical status classification'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242904', 'cui_str': 'General intravenous anesthetic'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0475746', 'cui_str': 'Light anesthesia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0026827', 'cui_str': 'Decreased muscle tone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",114.0,0.162691,"No significant differences in the mean arterial pressure, heart rate, bispectral index, extubation delay, or post-anesthesia care unit stay were found between groups.
","[{'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Strand', 'Affiliation': 'Department of Anesthesiology, Innlandet Hospital Trust, Sykehuset Lillehammer, Anders Sandvigs gate 17, 2609, Lillehammer, Norway. hilde.strand@sykehuset-innlandet.no.'}, {'ForeName': 'Ann Charlott', 'Initials': 'AC', 'LastName': 'Elshaug', 'Affiliation': 'Department of Anesthesiology, Østfold Hospital Trust, Sykehuset Østfold Kalnes, Kalnesveien 300, 1714, Grålum, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Bernersen', 'Affiliation': 'Department of Emergency, Anesthesiology and Intensive Care Unit, Innlandet Hospital Trust, Sykehuset Lillehammer, Anders Sandvigs gate 17, 2609, Lillehammer, Norway.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Ballangrud', 'Affiliation': 'Department of Health Science Gjøvik, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Teknologiveien 22, 2815, Gjøvik, Norway.'}]",BMC anesthesiology,['10.1186/s12871-022-01593-w']
2835,35227132,The relationship between neurotransmission-related amino acid blood concentrations and neuropsychological performance following acute exercise.,"Amino acid neurotransmitters, including glutamate, phenylalanine, tyrosine, alanine, and glycine, underlie the majority of the excitatory and inhibitory neurotransmission in the nervous system, and acute exercise has been shown to modulate their concentrations. We aimed to determine whether any correlation exists between the above-mentioned amino acid blood concentrations and the neuropsychological performance after an acute exercise intervention. Sixty basketball players were randomly assigned to one of two experimental conditions: exercise or inactive resting. All participants underwent a comprehensive neuropsychological assessment and blood samples were taken on a Guthrie card before and after the end of the experimental conditions. Amino acid blood concentrations were significantly elevated and cognitive performance significantly improved post-exercise on specific neuropsychological assessments. Significant intervention × group interaction effects were apparent for Trail Making Test part-B [F(1,58) = 20.46,  p  < .0001,  η 2  = .26] and Digit Span Backwards [F(1,58) = 15.47,  p  < .0001,  η 2  = .21] neuropsychological assessments. Additionally, regression analysis indicated that tyrosine accounted for 38.0% of the variance in the Trail Making Test part-A test. These results suggest that elevated blood concentrations of neurotransmission-related amino acids are associated with improved neuropsychological performance after a single bout of high-intensity exercise.",2022,Amino acid blood concentrations were significantly elevated and cognitive performance significantly improved post-exercise on specific neuropsychological assessments.,['Sixty basketball players'],['exercise or inactive resting'],"['cognitive performance', 'Amino acid blood concentrations', 'neuropsychological performance']","[{'cui': 'C0004818', 'cui_str': 'Basketball'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}]",,0.155786,Amino acid blood concentrations were significantly elevated and cognitive performance significantly improved post-exercise on specific neuropsychological assessments.,"[{'ForeName': 'Theodore P', 'Initials': 'TP', 'LastName': 'Parthimos', 'Affiliation': 'Division of Psychology, Faculty of Life and Health Sciences, De Montfort University, Leicester, UK.'}, {'ForeName': 'Kleopatra H', 'Initials': 'KH', 'LastName': 'Schulpis', 'Affiliation': 'Institute of Child Health, Research Center, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}, {'ForeName': 'Alexandra D', 'Initials': 'AD', 'LastName': 'Karousi', 'Affiliation': 'Department of Psychology, Human Sciences Research Centre, College of Life and Natural Sciences, University of Derby, Derby, UK.'}, {'ForeName': 'Yannis L', 'Initials': 'YL', 'LastName': 'Loukas', 'Affiliation': 'Laboratory of Pharm. Analysis, Department of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Dotsikas', 'Affiliation': 'Laboratory of Pharm. Analysis, Department of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.'}]",Applied neuropsychology. Adult,['10.1080/23279095.2022.2043327']
2836,35227582,Effectiveness of Repetitive Transcranial Magnetic Stimulation on Fibromyalgia Patients Responding to a First Repetitive Transcranial Magnetic Stimulation Induction Course After Six Months of Maintenance Treatment: A Randomized Pilot-Controlled Study.,"BACKGROUND


Fibromyalgia is a chronic painful condition without real, effective treatment. The administration of repetitive transcranial magnetic stimulation (rTMS) has been shown to have a therapeutic effect on pain, but there are still questions about the maintenance of its effect over time. Continuation of the treatment upon clinical response through maintenance sessions is promising and merits further exploration.
MATERIALS AND METHODS


We conducted a randomized, parallel-group, controlled study involving 78 patients to evaluate the effect of rTMS vs sham stimulation after a three-week induction treatment and six months of maintenance treatment (three-week periodicity) on 22 patients who presented a clinical response to the induction treatment. The clinical response was defined as a ≥30% decrease of the baseline visual analog scale (VAS) for pain and a score for the Patient Global Impression of Change (PGIC) >5. The clinic global impression, fibromyalgia impact questionnaire, symptom severity score, and Beck's depression inventory were also studied.
RESULTS


A significant clinical response to treatment with rTMS was observed after the induction phase and maintained over six months, particularly as measured by the PGIC parameter of pain, as well as of the intensity of fatigue and depression, with an absence of adverse effects induced by this method.
CONCLUSION


A three-week rTMS treatment, characterized by a reduction in pain, as evaluated by VAS, should be continued with the administration of rTMS maintenance sessions for an additional six months to maintain the best possible long-term effects.",2022,"The administration of repetitive transcranial magnetic stimulation (rTMS) has been shown to have a therapeutic effect on pain, but there are still questions about the maintenance of its effect over time.","['Fibromyalgia Patients Responding to a First Repetitive Transcranial Magnetic Stimulation Induction Course', '78 patients', '22 patients who presented a clinical response to the induction treatment']","['Repetitive Transcranial Magnetic Stimulation', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['baseline visual analog scale (VAS) for pain', ""clinic global impression, fibromyalgia impact questionnaire, symptom severity score, and Beck's depression inventory""]","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",78.0,0.0108418,"The administration of repetitive transcranial magnetic stimulation (rTMS) has been shown to have a therapeutic effect on pain, but there are still questions about the maintenance of its effect over time.","[{'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Lacroix', 'Affiliation': ""Unité de Recherche et d'Innovation, Centre Hospitalier Esquirol, Limoges, France; Inserm U1094, IRD U270, Université Limoges, CHU Limoges, EpiMaCT - Epidémiologie des maladies chroniques en zone tropicale, Institut d'Epidémiologie et de Neurologie Tropicale, OmegaHealth, Limoges, France. Electronic address: Aurelie.LACROIX@ch-esquirol-limoges.fr.""}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Vergne-Salle', 'Affiliation': 'Département de Rhumatologie et Centre de la Douleur, Centre Hospitalier Universitaire, Limoges, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Dumont', 'Affiliation': 'Département de Rhumatologie et Centre de la Douleur, Centre Hospitalier Universitaire, Limoges, France.'}, {'ForeName': 'Anaïs', 'Initials': 'A', 'LastName': 'Labrunie', 'Affiliation': ""Centre d'Epidémiologie, de Biostatistique et de Méthodologie de la Recherche, Centre Hospitalier Universitaire, Limoges, France.""}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Balestrat', 'Affiliation': ""Unité de Recherche et d'Innovation, Centre Hospitalier Esquirol, Limoges, France.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Calvet', 'Affiliation': ""Unité de Recherche et d'Innovation, Centre Hospitalier Esquirol, Limoges, France; Inserm U1094, IRD U270, Université Limoges, CHU Limoges, EpiMaCT - Epidémiologie des maladies chroniques en zone tropicale, Institut d'Epidémiologie et de Neurologie Tropicale, OmegaHealth, Limoges, France.""}, {'ForeName': 'Murielle', 'Initials': 'M', 'LastName': 'Girard', 'Affiliation': ""Unité de Recherche et d'Innovation, Centre Hospitalier Esquirol, Limoges, France; Inserm U1094, IRD U270, Université Limoges, CHU Limoges, EpiMaCT - Epidémiologie des maladies chroniques en zone tropicale, Institut d'Epidémiologie et de Neurologie Tropicale, OmegaHealth, Limoges, France.""}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1016/j.neurom.2021.12.015']
2837,35227553,Voice Therapy Outcome: A Comparison Between Imitation Model Voice Therapy and Verbal Instructions Model Voice Therapy.,"OBJECTIVES


The aim was to compare voice outcomes over time in patients treated with Imitation Model voice therapy and Verbal Instructions Model voice therapy.
METHODS


A prospective clinical trial was performed with 56 consecutive patients diagnosed with a primary or secondary functional voice disorder. Thirty-one patients were included for voice therapy following the Imitation Model and 25 patients for the Verbal Instructions Model. Assessments included a self-rated Voice Handicap Index, self-perceived hoarseness and vocal fatigue, perceptual voice evaluation by a Speech Language Pathologist, and maximum Voice Range Profiles. All assessments were completed before therapy, at end of therapy, at six-months posttherapy follow-up and 12-months posttherapy follow-up. For maximum Voice Range Profiles group differences were also compared for effects from end-of-treatment to follow-up assessments. Linear mixed models were used for analysis.
RESULTS


Comparison between treatment groups showed significantly larger long-term improvement from the baseline, for verbal instructions model as compared to imitation model for Voice Handicap Index total, and also the physical and emotional subscales, while there was no difference between groups for the functional subscale. Also, voice quality improved more after verbal instructions model, as compared to imitation model, at end of therapy. Results from self-rated hoarseness and vocal fatigue showed no difference between groups. There was no difference between treatment groups in the change of maximum Voice Range Profile from end-of-treatment to follow-up assessments.
CONCLUSIONS


The study showed that both Imitation Model voice therapy and Verbal Instructions Model voice therapy improved voice function. Compared to Imitation Model, the Verbal Instructions model showed larger long-term effect on physical and emotional aspects of voice function in everyday life. The two approaches for voice therapy might have different impacts on patients' learning.",2022,"There was no difference between treatment groups in the change of maximum Voice Range Profile from end-of-treatment to follow-up assessments.
","['56 consecutive patients diagnosed with a primary or secondary functional voice disorder', 'Thirty-one patients were included for voice therapy following the Imitation Model and 25 patients for the Verbal Instructions Model', 'patients treated with']","['Imitation Model Voice Therapy and Verbal Instructions Model Voice Therapy', 'Imitation Model voice therapy and Verbal Instructions Model voice therapy']","['voice function', 'self-rated Voice Handicap Index, self-perceived hoarseness and vocal fatigue, perceptual voice evaluation by a Speech Language Pathologist, and maximum Voice Range Profiles', 'voice quality', 'self-rated hoarseness and vocal fatigue', 'larger long-term improvement', 'Voice Handicap Index total, and also the physical and emotional subscales', 'Voice Therapy Outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0264622', 'cui_str': 'Psychogenic voice disorder'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0241700', 'cui_str': 'Vocal fatigue'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0334866', 'cui_str': 'Medical pathologist'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",56.0,0.0175927,"There was no difference between treatment groups in the change of maximum Voice Range Profile from end-of-treatment to follow-up assessments.
","[{'ForeName': 'Ann-Christine', 'Initials': 'AC', 'LastName': 'Ohlsson', 'Affiliation': 'Occupational and Environmental Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden. Electronic address: ann-christine.ohlsson@medfak.gu.se.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Occupational and Environmental Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Gustavsson', 'Affiliation': 'Department of Speech Language Pathology, ENT Clinic, Hospital of South of Älvsborg, Borås, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Hofling', 'Affiliation': 'Department of Speech Language Pathology, Hospital of Skaraborg (SkaS) Lidköping, Lidköping, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Wahle', 'Affiliation': 'Department of Logopedics and Phoniatrics, ENT Clinic, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Österlind', 'Affiliation': 'Department of Speech Language Pathology, NU- healthcare, Trollhättan, Sweden.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Iwarsson', 'Affiliation': 'Department of Scandinavian Studies and Linguistics, Audiologopedics, Copenhagen University, Copenhagen S, Denmark.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2022.01.018']
2838,35227800,Understanding who Benefits from Endovascular Aortic Repair in those Deemed Unfit for Open Repair.,"INTRODUCTION


Patients with abdominal aortic aneurysms (AAAs) who are deemed unacceptable candidates for open repair (UNFIT) pose a clinical challenge. The EVAR2 Trial randomized UNFIT patients to endovascular aortic repair (EVAR) versus no intervention from 1999-2003, concluding that survival was not improved by EVAR. However, outcomes following EVAR over the last two decades have dramatically changed. Thus, the purpose of this study was to evaluate outcomes following EVAR in UNFIT patients using more contemporary data and to determine which subsets of UNFIT patients may potentially benefit from EVAR.
METHODS


The Vascular Quality Initiative Database (2003-2020) was utilized to identify elective EVARs for AAAs. Patients were categorized as UNFIT or suitable (SUITABLE) for open repair by the operative surgeon. Predicted one-year mortality of untreated AAAs was calculated via a modified Gagne Index adjusted for AAA size. The primary outcome for the study was 30-day mortality. Secondary outcomes included perioperative major adverse cardiac events (MACE, a composite of clinically significant arrhythmia, congestive heart failure, and myocardial infarction), length of stay (LOS), and one-year mortality.
RESULTS


A total of 31,471 patients met study criteria with 27,036 (85.9%) deemed SUITABLE and 4,435 (14.1%) UNFIT. UNFIT patients were more likely to experience a perioperative MACE (5.1% versus 2.2%, P<.001) and had longer lengths of stay (1 day [IQR 1-3 days] versus 1 day [IQR 1-2 days], P<.001). The 30-day mortality was significantly higher for UNFIT patients (0.8% versus 0.4%, P<.001). UNFIT patients had worse one-year survival compared to SUITABLE patients. However, UNFIT and SUITABLE patients had significantly improved actual one-year mortality with EVAR compared to predicted one-year mortality without EVAR: 9.5% versus 15.6% (P<.001) and 4.0% versus 11.7% (P<.001), respectively. The mortality benefit following EVAR in UNFIT patients was primarily restricted to those with smaller Gagne Indices and larger aneurysm diameters. Patients deemed unsuitable for open repair due to frailty or multiple reasons had significantly higher 30-day mortality rates following EVAR when compared to SUITABLE patients (1.3% versus 1.6% versus 0.4%, P<.001). Those deemed unsuitable for open repair due to frailty or multiple reasons had worse one-year cumulative survival compared to all other UNFIT patients.
CONCLUSION


Despite being high-risk with higher perioperative morbidity and mortality, UNFIT patients have lower actual one-year mortality with EVAR than predicted one-year mortality without EVAR. However, this potential benefit is reserved to those with small Gagne Indices, larger AAA diameters, and lack of frailty.",2022,"Patients deemed unsuitable for open repair due to frailty or multiple reasons had significantly higher 30-day mortality rates following EVAR when compared to SUITABLE patients (1.3% versus 1.6% versus 0.4%, P<.001).","['31,471 patients met study criteria with 27,036 (85.9%) deemed SUITABLE and 4,435 (14.1%) UNFIT', 'UNFIT patients', 'Patients with abdominal aortic aneurysms (AAAs) who are deemed unacceptable candidates for open repair (UNFIT']","['endovascular aortic repair (EVAR', 'EVAR', 'Endovascular Aortic Repair']","['actual one-year mortality with EVAR', 'year survival', 'year cumulative survival', 'mortality benefit', 'perioperative MACE', 'perioperative major adverse cardiac events (MACE, a composite of clinically significant arrhythmia, congestive heart failure, and myocardial infarction), length of stay (LOS), and one-year mortality', 'longer lengths of stay', '30-day mortality rates', '30-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0441613', 'cui_str': 'Open repair of zygomatic fracture'}]","[{'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",31471.0,0.2598,"Patients deemed unsuitable for open repair due to frailty or multiple reasons had significantly higher 30-day mortality rates following EVAR when compared to SUITABLE patients (1.3% versus 1.6% versus 0.4%, P<.001).","[{'ForeName': 'Mitri K', 'Initials': 'MK', 'LastName': 'Khoury', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Heid', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Texas, Southwestern, Dallas, TX.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Rectenwald', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Acher', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Shirling', 'Initials': 'S', 'LastName': 'Tsai', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, University of Texas Southwestern Medical Center, Dallas, TX; Surgical Service, Dallas Veterans Affairs Medical Center, Dallas, TX.'}, {'ForeName': 'Bala', 'Initials': 'B', 'LastName': 'Ramanan', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, University of Texas Southwestern Medical Center, Dallas, TX; Surgical Service, Dallas Veterans Affairs Medical Center, Dallas, TX.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Timaran', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'J Gregory', 'Initials': 'JG', 'LastName': 'Modrall', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, University of Texas Southwestern Medical Center, Dallas, TX; Surgical Service, Dallas Veterans Affairs Medical Center, Dallas, TX. Electronic address: greg.modrall@utsouthwestern.edu.'}]",Journal of vascular surgery,['10.1016/j.jvs.2022.02.021']
2839,35227795,A prospective randomized trial on Endovascular Recanalization with Stenting versus Remote Endarterectomy for the Superficial Femoral Artery Total Occlusive Lesions.,"The objective of this randomized study was to compare the short and long-term safety and efficacy of the endovascular recanalization with stenting (EI) and the remote endarterectomy (RE) for patients with the superficial femoral artery (SFA) total occlusive lesions (≥250mm).
METHODS


Between July, 2013 and July, 2017, eligible patients with SFA total occlusive lesions were randomized to EI or RE. EI group underwent recanalization and stenting of long SFA atherosclerotic occlusive lesion. RE group underwent semi-closed endarterectomy. Short (30-day) and long-term (48 month) morbidity, mortality and patency rates were compared between both groups.
RESULTS


Of 400 patients assessed, 238 were ultimately randomized (119 EI and 119 RE). The cumulative primary patency were 83% (EI) vs 82% (RE) at 12 months and 28% (EI) vs 46% (RE) at 48 months (p=0.04).The limb salvage were 98% (EI) vs 95% (RE) at 12 months and 87% (EI) vs 92% (RE) at 48 months (p=0.26). One-year and four-year secondary patency were 98% and 87% in EI group and 100% and 90% in RE group, respectively (p=0.4). 65 patients in the stenting group and 32 patients in the endarterectomy group underwent endovascular re-intervention. Four-year patency of endovascular re-intervention subgroups were 37% and 60% (p = 0.04), respectively.
CONCLUSIONS


Remote endarterectomy shows in the long term significantly better results than primary stenting of the superficial femoral artery long lesions (TASC-II D lesions). In case of loss patency, a desobliterated artery can be successfully subjected to endovascular revascularization and stenting with good short and long-term results.",2022,"Four-year patency of endovascular re-intervention subgroups were 37% and 60% (p = 0.04), respectively.
","['65 patients in the stenting group and 32 patients in the endarterectomy group underwent', 'Superficial Femoral Artery Total Occlusive Lesions', 'patients with the superficial femoral artery (SFA) total occlusive lesions (≥250mm', 'Between July, 2013 and July, 2017', 'eligible patients with SFA total occlusive lesions', 'Of 400 patients assessed, 238 were ultimately randomized (119 EI and 119 RE']","['RE group underwent semi-closed endarterectomy', 'recanalization and stenting', 'endovascular re-intervention', 'endovascular recanalization with stenting (EI) and the remote endarterectomy (RE', 'Endovascular Recanalization with Stenting versus Remote Endarterectomy', 'EI or RE']","['cumulative primary patency', 'Short (30-day) and long-term (48 month) morbidity, mortality and patency rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014098', 'cui_str': 'Endarterectomy'}, {'cui': 'C0447106', 'cui_str': 'Superficial femoral artery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0205157', 'cui_str': 'Remote'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0014098', 'cui_str': 'Endarterectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0295997,"Four-year patency of endovascular re-intervention subgroups were 37% and 60% (p = 0.04), respectively.
","[{'ForeName': 'Sh', 'Initials': 'S', 'LastName': 'Saaya', 'Affiliation': 'Center for Vascular and Hybrid Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russian Federation. Electronic address: shoraans@gmail.ru.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Osipova', 'Affiliation': 'Center for Vascular and Hybrid Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gostev', 'Affiliation': 'Center for Vascular and Hybrid Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rabtsun', 'Affiliation': 'Center for Vascular and Hybrid Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Starodubtsev', 'Affiliation': 'Center for Vascular and Hybrid Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cheban', 'Affiliation': 'Center for Vascular and Hybrid Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ignatenko', 'Affiliation': 'Center for Vascular and Hybrid Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karpenko', 'Affiliation': 'Center for Vascular and Hybrid Surgery, Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}]",Journal of vascular surgery,['10.1016/j.jvs.2022.02.019']
2840,35227790,Lung Restriction in Breast Cancer Patients after Hypofractionated Tomotherapy and Conventional 3D Conformal Radiotherapy: a 10-year Follow-up.,"PURPOSE


Previous studies in breast cancer patients have shown acute radiotherapy-induced reductions of pulmonary diffusing capacity, essentially due to lung volume restriction. We aimed to assess the long-term effect of two radiotherapy regimens that differed in terms of radiation technique and dose fractionation, on lung function.
METHODS AND MATERIALS


From a randomized controlled trial comparing conventional 3D conformal radiotherapy (CR) and hypofractionated tomotherapy (TT), 84 breast cancer patients (age at inclusion 54±10(SD) years) could be assessed at baseline, after 3 months, 1, 2, 3 and 10 years. Measurements included forced vital capacity (FVC), total lung capacity (TLC) and diffusing capacity (TLco).
RESULTS


Radiotherapy-induced lung function changes over 10 years (Δ) were similar for both treatment arms, and in a patient subgroup with negligible history of respiratory disease or smoking (n=57) these averaged:  ΔFVC= -13 (±9)%predicted; ΔTLco= -14 (±12)%predicted; ΔTLC= -11 (±9)%predicted; the only significant correlation was between V20 and ΔTLco (rho=-0.36;p=0.007). In this subgroup as well as in the entire patient cohort, the incurred pulmonary restriction in terms of TLC and TLco showed a greater decline at 3 months for CR vs TT. However, at 10 years, no significant difference could be detected between CR and TT (P=0.9 for TLC and P=0.2 for TLco in the entire patient cohort). Of the patients with normal TLC and TLco at baseline (i.e., above lower limits of normal), respectively 94% and 96% were still normal 10 years later.
CONCLUSIONS


In women with breast cancer, conventional 3D conformal radiotherapy and hypofractionated tomotherapy induce similar restrictive lung patterns over the course of a 10-year period, despite some treatment dependent differences in the first 3 months. The large majority of women with normal lung function at baseline maintained a normal lung function status 10 years after radiotherapy, irrespective of treatment arm.",2022,"However, at 10 years, no significant difference could be detected between CR and TT (P=0.9 for TLC and P=0.2 for TLco in the entire patient cohort).","['Breast Cancer Patients after', 'women with breast cancer', '84 breast cancer patients (age at inclusion 54±10(SD) years', 'breast cancer patients', 'patient subgroup with negligible history of respiratory disease or smoking (n=57) these averaged:\xa0\xa0ΔFVC= -13']","['conventional 3D conformal radiotherapy (CR) and hypofractionated tomotherapy (TT', 'conventional 3D conformal radiotherapy and hypofractionated tomotherapy', 'Hypofractionated Tomotherapy and Conventional 3D Conformal Radiotherapy']","['Lung Restriction', 'lung function changes', 'forced vital capacity (FVC), total lung capacity (TLC) and diffusing capacity (TLco']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332269', 'cui_str': 'Negligible'}, {'cui': 'C0455540', 'cui_str': 'H/O: respiratory disease'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C1831735', 'cui_str': 'Helical Tomotherapies'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0040509', 'cui_str': 'Total lung capacity'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}]",84.0,0.115195,"However, at 10 years, no significant difference could be detected between CR and TT (P=0.9 for TLC and P=0.2 for TLco in the entire patient cohort).","[{'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Verbanck', 'Affiliation': 'Respiratory Division, University Hospital UZ Brussel, 1090 Brussels, Belgium. Electronic address: sylvia.verbanck@uzbrussel.be.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Van Parijs', 'Affiliation': 'Department of Radiotherapy, University Hospital UZ Brussel, 1090 Brussels, Belgium.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schuermans', 'Affiliation': 'Respiratory Division, University Hospital UZ Brussel, 1090 Brussels, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vinh-Hung', 'Affiliation': 'Department of Radiotherapy, University Hospital UZ Brussel, 1090 Brussels, Belgium.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Storme', 'Affiliation': 'Department of Radiotherapy, University Hospital UZ Brussel, 1090 Brussels, Belgium.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Fontaine', 'Affiliation': 'Department of Senology and Oncologic Surgery, UZ Brussel, 1090 Brussels, Belgium.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'De Ridder', 'Affiliation': 'Department of Radiotherapy, University Hospital UZ Brussel, 1090 Brussels, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Verellen', 'Affiliation': 'Iridium\xa0Netwerk\xa0and\xa0Faculty of Medicine and Health Sciences, Antwerp University, Antwerp, Belgium.'}, {'ForeName': 'Eef', 'Initials': 'E', 'LastName': 'Vanderhelst', 'Affiliation': 'Respiratory Division, University Hospital UZ Brussel, 1090 Brussels, Belgium.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Hanon', 'Affiliation': 'Respiratory Division, University Hospital UZ Brussel, 1090 Brussels, Belgium.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2022.02.021']
2841,35227777,Higher vs Standard Adalimumab Induction and Maintenance Dosing Regimens for Treatment of Ulcerative Colitis: SERENE UC Trial Results.,"BACKGROUND & AIMS


SERENE UC evaluated the efficacy of higher adalimumab induction and maintenance dose regimens in patients with ulcerative colitis (UC).
METHODS


This phase 3, double-blind, randomized trial included induction and maintenance studies, with a main study (ex-Japan) and Japan substudy. Eligible patients (18-75 years, full Mayo score [FMS] 6-12, centrally read endoscopy subscore 2-3) were randomized 3:2 to higher induction regimen (HIR; adalimumab 160mg at weeks 0, 1, 2, and 3) or standard induction regimen (SIR; 160mg at week 0, 80mg at week 2); all received 40mg at weeks 4 and 6. At week 8, all patients were rerandomized 2:2:1 (main study) to 40mg every week (ew), 40mg every other week (eow), or exploratory therapeutic drug monitoring; or 1:1 (Japan substudy) to 40mg ew or 40mg eow maintenance regimens.
RESULTS


In the main study, 13.3% vs 10.9% of patients receiving HIR vs SIR achieved clinical remission (FMS ≤2 with no subscore >1) at week 8 (induction primary endpoint; P=.265); among week-8 responders, 39.5% vs 29.0% receiving 40mg ew vs 40mg eow achieved clinical remission at week 52 (maintenance primary endpoint; P=.069). In the integrated (main+Japan) population, 41.1% vs 30.1% of week-8 responders receiving 40mg ew vs 40mg eow achieved clinical remission at week 52 (nominal P=.045). Safety profiles were comparable between dosing regimens.
CONCLUSION


Though primary endpoints were not met, a >10% absolute difference in clinical remission was demonstrated with higher adalimumab maintenance dosing. Higher dosing regimens were generally well tolerated and consistent with the known safety profile of adalimumab in UC. ClinicalTrials.gov number, NCT002209456.",2022,"Though primary endpoints were not met, a >10% absolute difference in clinical remission was demonstrated with higher adalimumab maintenance dosing.","['patients with ulcerative colitis (UC', 'Ulcerative Colitis', 'Eligible patients (18-75 years, full Mayo score [FMS] 6-12, centrally read endoscopy subscore 2-3']",['higher induction regimen (HIR; adalimumab'],"['Safety profiles', 'clinical remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.160283,"Though primary endpoints were not met, a >10% absolute difference in clinical remission was demonstrated with higher adalimumab maintenance dosing.","[{'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Panés', 'Affiliation': 'Hospital Clinic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain. Electronic address: jpanes@clinic.cat.'}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Colombel', 'Affiliation': 'Icahn School of Medicine at Mt Sinai, New York, NY, USA.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': 'University Hospital Schleswig-Holstein, Department Internal medicine I, Kiel University, Kiel, Germany.'}, {'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Department of Gastroenterology, CHRU-Nancy; NGERE, Inserm, University of Lorraine, Nancy, France.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Loftus', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tanida', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Aichi, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Okuyama', 'Affiliation': 'Department of Gastroenterology, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Louis', 'Affiliation': 'University Hospital CHU of Liège, Liège, Belgium.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Armuzzi', 'Affiliation': 'IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ferrante', 'Affiliation': 'University Hospitals Leuven, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Vogelsang', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hibi', 'Affiliation': 'Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Advanced Research Institute and Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lefebvre', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Finney-Hayward', 'Affiliation': 'AbbVie Ltd., Maidenhead, Berkshire, England, United Kingdom.'}, {'ForeName': 'Yuri Sanchez', 'Initials': 'YS', 'LastName': 'Gonzalez', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Thao T', 'Initials': 'TT', 'LastName': 'Doan', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Nael M', 'Initials': 'NM', 'LastName': 'Mostafa', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Ikeda', 'Affiliation': 'AbbVie GK, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Wangang', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Bidan', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Petersson', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Kalabic', 'Affiliation': 'AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Robinson', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}]",Gastroenterology,['10.1053/j.gastro.2022.02.033']
2842,35228291,"Therapeutic or prophylactic anticoagulation in acute isolated distal deep vein thrombosis: protocol for a prospective, multicentre, single-blind, randomised controlled trial (TOP-IDDVT).","INTRODUCTION


The efficacy and safety of anticoagulant treatment is not established for patients with acute symptomatic isolated distal deep vein thrombosis (IDDVT). In real-world clinical practice, both therapeutic and prophylactic anticoagulation are used for acute IDDVT. However, therapeutic anticoagulation is associated with higher risk of bleeding than prophylactic anticoagulation. Thus, this study aims to assess the efficacy and safety in patients with first acute symptomatic IDDVT treated with therapeutic or prophylactic anticoagulation using rivaroxaban.
METHODS AND ANALYSIS


This study is a prospective, multicentre, single-blind, randomised controlled trial. Outpatients with a first, acute, symptomatic, objectively confirmed IDDVT in four centres from 1 August 2021 are recruited. Eligible patients are randomised in a 1:1 ratio to receive prophylactic anticoagulation (rivaroxaban 10 mg once a day for 3 months) or therapeutic anticoagulation (rivaroxaban 20 mg once a day for 3 months). All patients are followed for 6 months. The primary efficacy outcome is radiographically confirmed recurrent venous thromboembolism. The primary safety outcome is the incidence of major or clinically relevant non-major bleeding events.
ETHICS AND DISSEMINATION


This study has been approved by the Ethics Committee of Zhongshan Hospital Fudan University (B2021-175R). Study results will be disseminated through peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT04967573.",2022,"Outpatients with a first, acute, symptomatic, objectively confirmed IDDVT in four centres from 1 August 2021 are recruited.","['Outpatients with a first, acute, symptomatic, objectively confirmed IDDVT in four centres from 1 August 2021 are recruited', 'patients with first acute symptomatic IDDVT treated with therapeutic or prophylactic anticoagulation using', 'acute isolated distal deep vein thrombosis', 'patients with acute symptomatic isolated distal deep vein thrombosis (IDDVT', 'Eligible patients']","['anticoagulant treatment', 'prophylactic anticoagulation (rivaroxaban 10\u2009mg once a day for 3 months) or therapeutic anticoagulation (rivaroxaban', 'Therapeutic or prophylactic anticoagulation', 'rivaroxaban']","['incidence of major or clinically relevant non-major bleeding events', 'radiographically confirmed recurrent venous thromboembolism', 'efficacy and safety']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C3162455', 'cui_str': 'rivaroxaban 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.187612,"Outpatients with a first, acute, symptomatic, objectively confirmed IDDVT in four centres from 1 August 2021 are recruited.","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Vascular Surgery, Huadong Hospital Affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Yucheng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Vascular Surgery, Wusong Branch, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Tianchen', 'Initials': 'T', 'LastName': 'Xie', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Jieqi', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'Department of Vascular Surgery, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital Fudan University, Shanghai, China shizhenyumax@163.com.'}]",BMJ open,['10.1136/bmjopen-2021-056826']
2843,35228288,PERFECTED enhanced recovery pathway (PERFECT-ER) versus standard acute hospital care for people after hip fracture surgery who have cognitive impairment: a feasibility cluster randomised controlled trial.,"OBJECTIVES


Assess feasibility of a cluster randomised controlled trial (RCT) to measure clinical and cost-effectiveness of an enhanced recovery pathway for people with hip fracture and cognitive impairment (CI).
DESIGN


Feasibility trial undertaken between 2016 and 2018.
SETTING


Eleven acute hospitals from three UK regions.
PARTICIPANTS


284 participants (208 female:69 male).
INCLUSION CRITERIA


aged >60 years, confirmed proximal hip fracture requiring surgical fixation and CI; preoperative AMTS ≤8 in England or a 4AT score ≥1 in Scotland; minimum of 5 days on study ward; a 'suitable informant' able to provide proxy measures, recruited within 7 days of hip fracture surgery.
EXCLUSION CRITERIA


no hip surgery; not expected to survive beyond 4 weeks; already enrolled in a clinical trial.
INTERVENTION


PERFECT-ER, an enhanced recovery pathway with 15 quality targets supported by a checklist and manual, a service improvement lead a process lead and implemented using a plan-do-study-act model.
PRIMARY AND SECONDARY OUTCOME MEASURES


Feasibility outcomes: recruitment and attrition, intervention acceptability, completion of participant reported outcome measures, preliminary estimates of potential effectiveness using mortality, EQ-5D-5L, economic and clinical outcome scores.
RESULTS


282 participants were consented and recruited (132, intervention) from a target of 400. Mean recruitment rates were the same in intervention and control sites, (range: 1.2 and 2.7 participants/month). Retention was 230 (86%) at 1 month and 54%(144) at 6 months. At 3 months a relatively small effect (one quarter of an SD) was observed on health-related quality of life of the patient measured with EQ-5D-5L proxy in the intervention group.
CONCLUSION


This trial design was feasible with modifications to recruitment. Mechanisms for delivering consistency in the PERFECT-ER intervention and participant retention need to be addressed. However, an RCT may be a suboptimal research design to evaluate this intervention due to the complexity of caring for people with CI after hip fracture.
TRIAL REGISTRATION NUMBER


ISRCTN99336264.",2022,"At 3 months a relatively small effect (one quarter of an SD) was observed on health-related quality of life of the patient measured with EQ-5D-5L proxy in the intervention group.
","['people with hip fracture and cognitive impairment (CI', '284 participants (208 female:69 male', '282 participants were consented and recruited (132, intervention) from a target of 400', ""aged >60 years, confirmed proximal hip fracture requiring surgical fixation and CI; preoperative AMTS ≤8 in England or a 4AT score ≥1 in Scotland; minimum of 5\u2009days on study ward; a 'suitable informant' able to provide proxy measures, recruited within 7\u2009days of hip fracture surgery"", 'people after hip fracture surgery who have cognitive impairment', 'no hip surgery', '2016 and 2018', 'Eleven acute hospitals from three UK regions']",['standard acute hospital care'],"['health-related quality of life of the patient measured with EQ-5D-5L proxy', 'Mean recruitment rates', 'potential effectiveness using mortality, EQ-5D-5L, economic and clinical outcome scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0042115', 'cui_str': 'Use-Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",282.0,0.254442,"At 3 months a relatively small effect (one quarter of an SD) was observed on health-related quality of life of the patient measured with EQ-5D-5L proxy in the intervention group.
","[{'ForeName': 'Jane L', 'Initials': 'JL', 'LastName': 'Cross', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK j.cross@uea.ac.uk.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Hammond', 'Affiliation': 'School of Education and Lifelong Learning, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Shepstone', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Poland', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Henderson', 'Affiliation': 'Care Policy and Evaluation Centre (CPEC), London School of Economics, London, UK, London, UK.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Backhouse', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Penhale', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Donell', 'Affiliation': 'Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Knapp', 'Affiliation': 'Care Policy and Evaluation Centre (CPEC), London School of Economics, London, UK, London, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Lewins', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Alasdair', 'Initials': 'A', 'LastName': 'MacLullich', 'Affiliation': 'Geriatric Medicine Unit, University of Edinburgh Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Opinder', 'Initials': 'O', 'LastName': 'Sahota', 'Affiliation': 'HCOP, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Toby O', 'Initials': 'TO', 'LastName': 'Smith', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Waring', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Howard', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Ballard', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}]",BMJ open,['10.1136/bmjopen-2021-055267']
2844,35228279,"Safety, feasibility, acceptability and preliminary effects of the Neurofenix platform for Rehabilitation via HOMe Based gaming exercise for the Upper-limb post Stroke (RHOMBUS): results of a feasibility intervention study.","OBJECTIVES


To investigate the safety, feasibility and acceptability of the Neurofenix platform for home-based rehabilitation of the upper limb (UL).
DESIGN


A non-randomised intervention design with a parallel process evaluation.
SETTING


Participants' homes, South-East England.
PARTICIPANTS


Thirty adults (≥18 years), minimum 12-week poststroke, not receiving UL rehabilitation, scoring 9-25 on the Motricity Index (elbow and shoulder), with sufficient cognitive and communicative abilities to participate.
INTERVENTIONS


Participants were trained to use the platform, followed by 1 week of graded game-play exposure and 6-week training, aiming for a minimum 45 min, 5 days/week.
OUTCOMES


Safety was determined by assessing pain and poststroke fatigue at 8 and 12 weeks, and adverse events (AEs). Impairment, activity and participation outcomes were measured. Intervention feasibility was determined by the amount of specialist training and support required to complete the intervention, time and days spent training, and number of UL movements performed. Acceptability was assessed by a satisfaction questionnaire and semistructured interviews.
RESULTS


Participants (14 women; mean (SD) age 60.0 (11.3) years) were a median of 4.9 years poststroke (minimum-maximum: 1-28 years). Twenty-seven participants completed the intervention. The odds of having shoulder pain were lower at 8 weeks (OR 0.45, 95% CI 0.24 to 0.83, p=0.010) and 12 weeks (OR 0.46, 95% CI 0.25 to 0.86, p=0.014) compared with baseline. Fugl-Meyer upper extremity, Motor Activity Log and passive range of movement improved. No other gains were recorded. Poststroke fatigue did not change. Thirty mild and short-term AEs and one serious (unrelated) AE were reported by 19 participants. Participants trained with the platform for a median of 17.4 hours over 7 weeks (minimum-maximum: 0.3-46.9 hours), equating to a median of 149 min per week. The median satisfaction score was 36 out of 40.
CONCLUSION


The Neurofenix platform is a safe, feasible and well accepted way to support UL training for people at least three months poststroke.
TRIAL REGISTRATION NUMBER


ISRCTN60291412.",2022,"The odds of having shoulder pain were lower at 8 weeks (OR 0.45, 95% CI 0.24 to 0.83, p=0.010) and 12 weeks (OR 0.46, 95% CI 0.25 to 0.86, p=0.014) compared with baseline.","[""Participants' homes, South-East England"", 'Participants (14\u2009women; mean (SD) age 60.0 (11.3) years) were a median of 4.9 years poststroke (minimum-maximum: 1-28 years', 'Thirty adults (≥18 years), minimum 12-week poststroke, not receiving UL rehabilitation, scoring 9-25 on the Motricity Index (elbow and shoulder), with sufficient cognitive and communicative abilities to participate', 'Upper-limb post Stroke (RHOMBUS']","['Neurofenix platform', 'Neurofenix platform for Rehabilitation via HOMe Based gaming exercise']","['Poststroke fatigue', 'odds of having shoulder pain', 'median satisfaction score', 'pain and poststroke fatigue at 8 and 12\u2009weeks, and adverse events (AEs', 'safety, feasibility and acceptability', 'Acceptability', 'Safety, feasibility, acceptability', 'Impairment, activity and participation outcomes', 'Fugl-Meyer upper extremity, Motor Activity Log and passive range of movement improved']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451322', 'cui_str': 'Motricity index'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",27.0,0.073835,"The odds of having shoulder pain were lower at 8 weeks (OR 0.45, 95% CI 0.24 to 0.83, p=0.010) and 12 weeks (OR 0.46, 95% CI 0.25 to 0.86, p=0.014) compared with baseline.","[{'ForeName': 'Cherry', 'Initials': 'C', 'LastName': 'Kilbride', 'Affiliation': 'Department of Health Sciences, Brunel University London, London, UK Cherry.Kilbride@brunel.ac.uk.'}, {'ForeName': 'Daniel J M', 'Initials': 'DJM', 'LastName': 'Scott', 'Affiliation': 'Department of Health Sciences, Brunel University London, London, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Butcher', 'Affiliation': 'Department of Health Sciences, Brunel University London, London, UK.'}, {'ForeName': 'Meriel', 'Initials': 'M', 'LastName': 'Norris', 'Affiliation': 'Department of Health Sciences, Brunel University London, London, UK.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Warland', 'Affiliation': 'Department of Health Sciences, Brunel University London, London, UK.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Anokye', 'Affiliation': 'Department of Health Sciences, Brunel University London, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cassidy', 'Affiliation': 'Freelance Academic and Research Supervisor, London, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Baker', 'Affiliation': 'Department of Health Sciences, Brunel University London, London, UK.'}, {'ForeName': 'Dimitrios A', 'Initials': 'DA', 'LastName': 'Athanasiou', 'Affiliation': 'Neurofenix, London, UK.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Singla-Buxarrais', 'Affiliation': 'Neurofenix, London, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nowicky', 'Affiliation': 'Department of Health Sciences, Brunel University London, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': 'Department of Health Sciences, Brunel University London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2021-052555']
2845,35228237,Management of reformation of imperforate hymen following hymenectomy by double cross plasty surgery.,,2022,,[],['hymenectomy by double cross plasty surgery'],[],[],"[{'cui': 'C0195147', 'cui_str': 'Hymenectomy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],,0.177822,,"[{'ForeName': 'Mohd Fairudzi Afzanizam', 'Initials': 'MFA', 'LastName': 'Salleh', 'Affiliation': 'Department of Obstetrics & Gynaecology, Hospital Sultanah Nur Zahirah, Kuala Terengganu, Terengganu, Malaysia.'}, {'ForeName': 'Roziana', 'Initials': 'R', 'LastName': 'Ramli', 'Affiliation': 'Department of Obstetrics & Gynaecology, Hospital Sultanah Nur Zahirah, Kuala Terengganu, Terengganu, Malaysia drroziana@yahoo.com.'}]",BMJ case reports,['10.1136/bcr-2021-247589']
2846,35228163,Temporal and specific pathways of change in cognitive behavioral therapy (CBT) and interpersonal psychotherapy (IPT) for depression.,"BACKGROUND


The present study investigated the specific and temporal role of putative mechanisms of change in cognitive-behavioral therapy (CBT) and interpersonal psychotherapy (IPT) for major depressive disorder (MDD).
METHOD


200 patients were randomized to CBT weekly, CBT twice weekly, IPT weekly or IPT twice weekly. Outcome and putative mechanisms of change (i.e., dysfunctional thinking, behavioral activation, CBT skills, IPT skills, therapeutic alliance, compliance, motivation) were measured multiple times up to six months after the start of treatment. Latent change score models were used to investigate temporal relations and test mediation. Explorative analyses tested whether baseline working memory moderated the effect of mechanism change on outcome change.
RESULTS


CBT skills and dysfunctional thinking mediated the relation between treatment modality and changes in depression. In both treatments, IPT skills and behavioral activation were related to subsequent change in depression while a decrease in depression led to subsequent improvement in therapeutic alliance and a decrease in autonomous motivation. Change in compliance was unrelated to change in depression. Baseline working memory was related to therapy skill improvement.
CONCLUSION


CBT skill improvement seems a specific mechanism of change leading to subsequent decrease in depression in CBT. Changes in IPT skills acted as a non-specific mechanism, subsequently reducing depression regardless of treatment modality. The specific role of cognitive change and behavioral activation remains unclear. Future studies should investigate the specificity and direction of the potential mechanisms of change throughout the course of therapy and investigate whether these mechanistic pathways differ between individuals.",2021,"In both treatments, IPT skills and behavioral activation were related to subsequent change in depression while a decrease in depression led to subsequent improvement in therapeutic alliance and a decrease in autonomous motivation.","['major depressive disorder (MDD', '200 patients']","['CBT', 'IPT weekly or IPT', 'cognitive behavioral therapy (CBT) and interpersonal psychotherapy (IPT', 'cognitive-behavioral therapy (CBT) and interpersonal psychotherapy (IPT']","['IPT skills and behavioral activation', 'autonomous motivation', 'Outcome and putative mechanisms of change (i.e., dysfunctional thinking, behavioral activation, CBT skills, IPT skills, therapeutic alliance, compliance, motivation']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",200.0,0.025466,"In both treatments, IPT skills and behavioral activation were related to subsequent change in depression while a decrease in depression led to subsequent improvement in therapeutic alliance and a decrease in autonomous motivation.","[{'ForeName': 'Sanne J E', 'Initials': 'SJE', 'LastName': 'Bruijniks', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Freiburg, Freiburg, Germany. Electronic address: sanne.bruijniks@psychologie.uni-freiburg.de.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Meeter', 'Affiliation': 'Vrije Universiteit Amsterdam, LEARN! Research Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Lotte H J M', 'Initials': 'LHJM', 'LastName': 'Lemmens', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Frenk', 'Initials': 'F', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands.'}, {'ForeName': 'Marcus J H', 'Initials': 'MJH', 'LastName': 'Huibers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands; Department of Psychology, University of Pennsylvania, Philadelphia, United States.'}]",Behaviour research and therapy,['10.1016/j.brat.2021.104010']
2847,35231057,Nurturing compassion in schools: A randomized controlled trial of the effectiveness of a Compassionate Mind Training program for teachers.,"OBJECTIVES


Schools are experiencing an unprecedented mental health crisis, with teachers reporting high levels of stress and burnout, which has adverse consequences to their mental and physical health. Addressing mental and physical health problems and promoting wellbeing in educational settings is thus a global priority. This study investigated the feasibility and effectiveness of an 8-week Compassionate Mind Training program for Teachers (CMT-T) on indicators of psychological and physiological wellbeing.
METHODS


A pragmatic randomized controlled study with a stepped-wedge design was conducted in a sample of 155 public school teachers, who were randomized to CMT-T (n = 80) or a waitlist control group (WLC; n = 75). Participants completed self-report measures of psychological distress, burnout, overall and professional wellbeing, compassion and self-criticism at baseline, post-intervention, and 3-months follow-up. In a sub-sample (CMT-T, n = 51; WLC n = 36) resting heart-rate variability (HRV) was measured at baseline and post-intervention.
RESULTS


CMT-T was feasible and effective. Compared to the WLC, the CMT-T group showed improvements in self-compassion, compassion to others, positive affect, and HRV as well as reductions in fears of compassion, anxiety and depression. WLC participants who received CMT-T revealed additional improvements in compassion for others and from others, and satisfaction with professional life, along with decreases in burnout and stress. Teachers scoring higher in self-criticism at baseline revealed greater improvements post CMT-T. At 3-month follow-up improvements were retained.
CONCLUSIONS


CMT-T shows promise as a compassion-focused intervention for enhancing compassion, wellbeing and reducing psychophysiological distress in teachers, contributing to nurturing compassionate, prosocial and resilient educational environments. Given its favourable and sustainable effects on wellbeing and psychophysiological distress, and low cost to deliver, broader implementation and dissemination of CMT-T is encouraged.",2022,"WLC participants who received CMT-T revealed additional improvements in compassion for others and from others, and satisfaction with professional life, along with decreases in burnout and stress.","['teachers', '155 public school teachers', 'Nurturing compassion in schools']","['Compassionate Mind Training program', 'Compassionate Mind Training program for Teachers (CMT-T', 'waitlist control group (WLC', 'CMT-T']","['wellbeing and psychophysiological distress', 'self-compassion, compassion to others, positive affect, and HRV', 'fears of compassion, anxiety and depression', 'psychological distress, burnout, overall and professional wellbeing, compassion and self-criticism', 'heart-rate variability (HRV']","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1510633', 'cui_str': 'Self-Criticism'}]",155.0,0.0648924,"WLC participants who received CMT-T revealed additional improvements in compassion for others and from others, and satisfaction with professional life, along with decreases in burnout and stress.","[{'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Matos', 'Affiliation': 'University of Coimbra, Faculty of Psychology and Educational Sciences, Center for Research in Neuropsychology and Cognitive and Behavioural Intervention (CINEICC), Coimbra, Portugal.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Albuquerque', 'Affiliation': 'University of Coimbra, Faculty of Psychology and Educational Sciences, Center for Research in Neuropsychology and Cognitive and Behavioural Intervention (CINEICC), Coimbra, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Galhardo', 'Affiliation': 'University of Coimbra, Faculty of Psychology and Educational Sciences, Center for Research in Neuropsychology and Cognitive and Behavioural Intervention (CINEICC), Coimbra, Portugal.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Cunha', 'Affiliation': 'University of Coimbra, Faculty of Psychology and Educational Sciences, Center for Research in Neuropsychology and Cognitive and Behavioural Intervention (CINEICC), Coimbra, Portugal.'}, {'ForeName': 'Margarida', 'Initials': 'M', 'LastName': 'Pedroso Lima', 'Affiliation': 'University of Coimbra, Faculty of Psychology and Educational Sciences, Center for Research in Neuropsychology and Cognitive and Behavioural Intervention (CINEICC), Coimbra, Portugal.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Palmeira', 'Affiliation': 'University of Coimbra, Faculty of Psychology and Educational Sciences, Center for Research in Neuropsychology and Cognitive and Behavioural Intervention (CINEICC), Coimbra, Portugal.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Petrocchi', 'Affiliation': 'John Cabot University, Rome, Italy.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'McEwan', 'Affiliation': 'University of Derby, College of Health, Psychology & Social Care, Derby, United Kingdom.'}, {'ForeName': 'Frances A', 'Initials': 'FA', 'LastName': 'Maratos', 'Affiliation': 'University of Derby, College of Health, Psychology & Social Care, Derby, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gilbert', 'Affiliation': 'University of Derby, College of Health, Psychology & Social Care, Derby, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0263480']
2848,35231024,"Effectiveness of a monthly schedule of follow-up for the treatment of uncomplicated severe acute malnutrition in Sokoto, Nigeria: A cluster randomized crossover trial.","BACKGROUND


Community-based management of severe acute malnutrition (SAM) involves weekly or biweekly outpatient clinic visits for clinical surveillance and distribution of therapeutic foods. Distance to outpatient clinics and high opportunity costs for caregivers can represent major barriers to access. Reducing the frequency of outpatient visits while providing training to caregivers to recognize clinical danger signs at home between outpatient visits may increase acceptability, coverage, and public health impact of SAM treatment. We investigated the effectiveness of monthly clinic visits compared to the standard weekly follow-up in the outpatient treatment of uncomplicated SAM in northwestern Nigeria.
METHODS AND FINDINGS


We conducted a cluster randomized crossover trial to test the noninferiority of nutritional recovery in children with uncomplicated SAM receiving monthly follow-up compared to the standard weekly schedule. From January 2018 to November 2019, 3,945 children aged 6 to 59 months were enrolled at 10 health centers (5 assigned to monthly follow-up and 5 assigned to weekly follow-up) in Sokoto, Nigeria. In total, 96% of children (n = 1,976 in the monthly follow-up group and 1,802 in the weekly follow-up group) were followed until program discharge, and 91% (n = 1,873 in the monthly follow-up group and 1,721 in the weekly follow-up group) were followed to 3 months postdischarge. The mean age at admission was 15.8 months (standard deviation [SD] 7.1), 2,097/3,945 (53.2%) were girls, and the mean midupper arm circumference (MUAC) at admission was 105.8 mm (SD 6.0). In a modified intention-to-treat analysis, the primary outcome of nutritional recovery, defined as having MUAC ≥125 mm on 2 consecutive visits, was analyzed using generalized linear models, with generalized estimating equations to account for clustering. Nutritional recovery was lower in the monthly follow-up group compared to the weekly group (1,036/1,976, 52.4% versus 1,059/1,802, 58.8%; risk difference: -6.8%), and noninferiority was not demonstrated (lower bound of the confidence interval [CI] was -11.5%, lower than the noninferiority margin of 10%). The proportion of children defaulting was lower in the monthly group than in the weekly group (109/1,976, 5.5% versus 151/1,802, 8.4%, p = 0.03). Three months postdischarge, children in the monthly group were less likely to relapse compared to those in the weekly group (58/976, 5.9% versus 78/1,005, 7.8%, p = 0.03), but cumulative mortality at 3 months postdischarge was higher in the monthly group (159/1,873, 8.5% versus 106/1,721, 6.2%, p < 0.001). Study results may depend on context-specific factors including baseline level of care and the clinical status of children presenting to health centers, and, thus, generalizability of these results may be limited.
CONCLUSIONS


Where feasible, a weekly schedule of clinic visits should be preferred to maintain effectiveness of SAM treatment. Where geographic coverage of programs is low or frequent travel to outpatient clinics is difficult or impossible, a monthly schedule of visits may provide an alternative model to deliver treatment to those in need. Modifications to the outpatient follow-up schedule, for example, weekly clinic visits until initial weight gain has been achieved followed by monthly visits, could increase the effectiveness of the model and add flexibility for program delivery.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03140904.",2022,"Three months postdischarge, children in the monthly group were less likely to relapse compared to those in the weekly group (58/976, 5.9% versus 78/1,005, 7.8%, p = 0.03), but cumulative mortality at 3 months postdischarge was higher in the monthly group (159/1,873, 8.5% versus 106/1,721, 6.2%, p < 0.001).","['uncomplicated SAM in northwestern Nigeria', 'children presenting to health centers', 'uncomplicated severe acute malnutrition in Sokoto, Nigeria', 'From January 2018 to November 2019, 3,945 children aged 6 to 59 months were enrolled at 10 health centers', 'severe acute malnutrition (SAM', 'children with uncomplicated SAM receiving monthly follow-up compared to the standard weekly schedule']",[],"['frequency of outpatient visits', 'cumulative mortality', 'proportion of children defaulting', 'Nutritional recovery', 'relapse']","[{'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]",[],"[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",3945.0,0.0675475,"Three months postdischarge, children in the monthly group were less likely to relapse compared to those in the weekly group (58/976, 5.9% versus 78/1,005, 7.8%, p = 0.03), but cumulative mortality at 3 months postdischarge was higher in the monthly group (159/1,873, 8.5% versus 106/1,721, 6.2%, p < 0.001).","[{'ForeName': 'Matt D T', 'Initials': 'MDT', 'LastName': 'Hitchings', 'Affiliation': 'Department of Biology, University of Florida, Gainesville, Florida, United States of America.'}, {'ForeName': 'Fatou', 'Initials': 'F', 'LastName': 'Berthé', 'Affiliation': 'Epicentre Niger, Niamey, Niger.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Aruna', 'Affiliation': 'Médecins Sans Frontières-Operational Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Shehu', 'Affiliation': 'Epicentre Niger, Niamey, Niger.'}, {'ForeName': 'Muhammed Ali', 'Initials': 'MA', 'LastName': 'Hamza', 'Affiliation': 'Sokoto State Nutrition Office, Sokoto, Nigeria.'}, {'ForeName': 'Siméon', 'Initials': 'S', 'LastName': 'Nanama', 'Affiliation': 'UNICEF West and Central Regional Office, Dakar, Senegal.'}, {'ForeName': 'Chizoba', 'Initials': 'C', 'LastName': 'Steve-Edemba', 'Affiliation': 'UNICEF Nigeria, Abuja, Nigeria.'}, {'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Grais', 'Affiliation': 'Epicentre, Paris, France.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Isanaka', 'Affiliation': 'Epicentre, Paris, France.'}]",PLoS medicine,['10.1371/journal.pmed.1003923']
2849,35231017,Local Triamcinolone Treatment Affects Inflammatory Response in Seroma Exudate of Abdominoplasty Patients: A Randomized Controlled Trial.,,2022,,['Seroma Exudate of Abdominoplasty Patients'],['Local Triamcinolone'],[],"[{'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0015388', 'cui_str': 'Exudate'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}]",[],,0.199313,,"[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Hwang', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000008935']
2850,35231002,"Optimal Dosing of Prophylactic Enoxaparin after Surgical Procedures: Results of the Double-Blind, Randomized, Controlled FIxed or Variable Enoxaparin (FIVE) Trial.",,2022,,[],['Prophylactic Enoxaparin'],[],[],"[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]",[],,0.83241,,"[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Swanson', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000008915']
2851,35230997,Reply: Local Triamcinolone Treatment Affects Inflammatory Response in Seroma Exudate of Abdominoplasty Patients: A Randomized Controlled Trial.,,2022,,['Seroma Exudate of Abdominoplasty Patients'],['Triamcinolone'],[],"[{'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0015388', 'cui_str': 'Exudate'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}]",[],,0.193293,,"[{'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Anker', 'Affiliation': 'Center for Plastic, Reconstructive, Aesthetic, and Hand Surgery University Hospital Regensburg and Caritas Hospital St. Josef Regensburg Regensburg, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Prantl', 'Affiliation': 'Center for Plastic, Reconstructive, Aesthetic, and Hand Surgery University Hospital Regensburg and Caritas Hospital St. Josef Regensburg Regensburg, Germany.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Vykoukal', 'Affiliation': 'Department of Clinical Cancer Prevention and The McCombs Institute for the Early Detection and Treatment of Cancer University of Texas M. D. Anderson Cancer Center Houston, Texas.'}, {'ForeName': 'Silvan M', 'Initials': 'SM', 'LastName': 'Klein', 'Affiliation': 'Center for Plastic, Reconstructive, Aesthetic, and Hand Surgery University Hospital Regensburg and Caritas Hospital St. Josef Regensburg Regensburg, Germany.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000008936']
2852,35230988,Optimizing oxygen delivery to the injured brain.,"PURPOSE OF REVIEW


The principle of optimizing oxygen delivery to the injured brain rests on the premise that both hypoxia and hyperoxia are important mediators of secondary brain injury and should be avoided. This rationale has prompted a move towards incorporating oxygenation endpoints into the management of neurocritical care patients, particularly those with traumatic brain injury. The present review will seek to describe clinical strategies to optimize oxygenation in the acutely brain-injured patient, drawing upon relevant physiologic principles and clinical data, where it exists.
RECENT FINDINGS


A phase II randomized trial found that a protocolized approach to improving oxygen delivery resulted in less duration of brain hypoxia and a trend towards lower mortality among patients with severe traumatic brain injury. Recent clinical protocols have been published to guide oxygen delivery based on core physiologic principles: increasing oxygen supply via modulation of mean arterial pressure and intracranial pressure, blood oxygen carrying capacity, and cerebral vasoreactivity; and decreasing oxygen demand via sedation, pharmacologic coma, and hypothermia.
SUMMARY


Although there is growing interest in the use of brain tissue oxygenation as a resuscitative endpoint, many of these therapies are based on physiologic principles with little robust clinical evidence to guide their application. Clinicians must be mindful of this and balance the putative benefits of improving oxygenation against the risks associated with the use of such therapies.",2022,"RECENT FINDINGS


A phase II randomized trial found that a protocolized approach to improving oxygen delivery resulted in less duration of brain hypoxia and a trend towards lower mortality among patients with severe traumatic brain injury.","['neurocritical care patients, particularly those with traumatic brain injury', 'patients with severe traumatic brain injury']",[],['duration of brain hypoxia'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",[],"[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1527348', 'cui_str': 'Hypoxia of brain'}]",,0.0688972,"RECENT FINDINGS


A phase II randomized trial found that a protocolized approach to improving oxygen delivery resulted in less duration of brain hypoxia and a trend towards lower mortality among patients with severe traumatic brain injury.","[{'ForeName': 'Shaurya', 'Initials': 'S', 'LastName': 'Taran', 'Affiliation': 'Interdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Robba', 'Affiliation': 'Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences.'}]",Current opinion in critical care,['10.1097/MCC.0000000000000913']
2853,35230980,The Table I Fallacy: P Values in Baseline Tables of Randomized Controlled Trials.,,2022,,[],[],[],[],[],[],,0.454935,,"[{'ForeName': 'Bart G', 'Initials': 'BG', 'LastName': 'Pijls', 'Affiliation': 'Department of Orthopaedics, Leiden University Medical Center, Leiden, the Netherlands.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.21.01166']
2854,35230962,Web-Based Single Session Intervention for Perceived Control Over Anxiety During COVID-19: Randomized Controlled Trial.,"BACKGROUND


Anxiety is rising across the United States during the COVID-19 pandemic, and social distancing mandates preclude in-person mental healthcare. Greater perceived control over anxiety has predicted decreased anxiety pathology, including adaptive responses to uncontrollable stressors. Evidence suggests that no-therapist, single-session interventions can strengthen perceived control over emotions like anxiety; similar programs, if designed for the COVID-19 context, could hold substantial public health value.
OBJECTIVE


Our registered report evaluated a no-therapist, single-session, online intervention targeting perceived control over anxiety in the COVID-19 context against a placebo intervention encouraging hand-washing. We tested whether the intervention could: 1) decrease generalized anxiety and increase perceived control over anxiety and 2) achieve this without decreasing social-distancing intentions.
METHODS


We tested these questions using a between-subjects design in a weighted-probability sample of U.S. adults recruited via closed online platform (i.e., Prolific). All outcomes were indexed via online self-report questionnaires.
RESULTS


500 of 522 randomized individuals (95.8%) completed the baseline survey and intervention. Intent-to-treat analyses using all randomized participants (N=522) found no support for therapeutic or iatrogenic effects; effects on generalized anxiety were d = -0.06 (P =.48, CI [-0.27, 0.15]), effects on perceived control were d = 0.04 (P =.48, CI [-0.08, 0.16]), and effects on social-distancing intentions were d = -0.02 (P =.83, CI [-0.23, 0.19]).
CONCLUSIONS


Strengths of this study included a large, nationally representative sample and adherence to open science practices. Implications for scalable interventions, including the challenge of targeting perceived control over anxiety, are discussed.
CLINICALTRIAL


Clinicaltrials.gov NCT04459455.",2022,"We tested whether the intervention could: 1) decrease generalized anxiety and increase perceived control over anxiety and 2) achieve this without decreasing social-distancing intentions.
","['subjects design in a weighted-probability sample of U.S. adults recruited via closed online platform (i.e., Prolific', '500 of 522 randomized individuals (95.8%) completed the baseline survey and intervention']",[],"['indexed via online self-report questionnaires', 'generalized anxiety', 'social-distancing intentions']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0033206', 'cui_str': 'Probability Sample'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0645469,"We tested whether the intervention could: 1) decrease generalized anxiety and increase perceived control over anxiety and 2) achieve this without decreasing social-distancing intentions.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mullarkey', 'Affiliation': 'University of Texas at Austin, Institute for Mental Health Research, 110 Inner Campus DriveStop G6000, Austin, US.'}, {'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Dobias', 'Affiliation': 'Stony Brook University, Department of Psychology, Stony Brook, US.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Sung', 'Affiliation': 'Stony Brook University, Department of Psychology, Stony Brook, US.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Ahuvia', 'Affiliation': 'Stony Brook University, Department of Psychology, Stony Brook, US.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Shumake', 'Affiliation': 'University of Texas at Austin, Institute for Mental Health Research, 110 Inner Campus DriveStop G6000, Austin, US.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Beevers', 'Affiliation': 'University of Texas at Austin, Institute for Mental Health Research, 110 Inner Campus DriveStop G6000, Austin, US.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Schleider', 'Affiliation': 'Stony Brook University, Department of Psychology, Stony Brook, US.'}]",JMIR mental health,['10.2196/33473']
2855,35231803,The burden of multiple sclerosis among postpartum women and self management's challenges: Pilot study of supportive program.,"BACKGROUND


This study aims to determine the effect of multiple sclerosis supportive programs on mothers' self-management during postpartum.
STUDY DESIGN


A quasi-experimental, nonequivalent group design was utilized. Primigravida pregnant women between 35-37 weeks of gestation and recently diagnosed with multiple sclerosis participated in two preparation sessions. While the first session during pregnancy was an open conversation about the delivery, the key topics of the second session were the nature of the postpartum cycle and the expected relapses.
RESULTS


Seventy pregnant women with multiple sclerosis participated in this research. Results denoted a statistical difference between both groups regarding self-management in 6 th  and 12 th  weeks postpartum. The improvements were related to mothers' relationships with their health care providers and knowledge and information about multiple sclerosis during this transitional phase. On the other hand, there were no differences among both groups related to their levels of functional activities at 6 th  and 12 th  weeks postpartum. Although there was a slight deterioration in motor ability score among both groups at 12 th  week's postpartum, 54.3% of the intervention group vs. 49% of the non-intervention group reported 100% absolute independence. Moreover, the total relapses in the three-month postpartum ranged between 1-6, increasing the frequency of relapses during the three-month postpartum with no statistically significant differences between both groups.
CONCLUSION


Conducting a multidisciplinary program to follow and counsel mothers with MS helps enhance self-management throughout the three-month postpartum period.",2022,The improvements were related to mothers' relationships with their health care providers and knowledge and information about multiple sclerosis during this transitional phase.,"['Seventy pregnant women with multiple sclerosis', ""mothers' self-management during postpartum"", 'Primigravida pregnant women between 35-37 weeks of gestation and recently diagnosed with multiple sclerosis participated in two preparation sessions']",['multiple sclerosis supportive programs'],"['motor ability score', 'frequency of relapses', 'total relapses', 'levels of functional activities']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0860096', 'cui_str': 'Primigravida'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",70.0,0.00987157,The improvements were related to mothers' relationships with their health care providers and knowledge and information about multiple sclerosis during this transitional phase.,"[{'ForeName': 'Amel Dawod', 'Initials': 'AD', 'LastName': 'Kamel', 'Affiliation': 'Department of Maternal and Newborn Health Nursing, Faculty of Nursing, Cairo University-Egypt.'}, {'ForeName': 'Rania Mahmoud Abdel', 'Initials': 'RMA', 'LastName': 'Ghani', 'Affiliation': 'Department of Maternal and Newborn Health Nursing, Faculty of Nursing, Cairo University-Egypt.'}, {'ForeName': 'Mona Rkhiyes', 'Initials': 'MR', 'LastName': 'Alanazi', 'Affiliation': 'King Saud Bin Abdulaziz University for Health Sciences, College of Nursing, Riyadh, Saudi Arabia. King Abdullah International Medical Research Cente, Riyadh, Saudi arabia. Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia. Electronic address: Dr.mona@mail.com.'}, {'ForeName': 'Shahira Mohamed', 'Initials': 'SM', 'LastName': 'Metwaly', 'Affiliation': 'Department of Community Health Nursing, College of Nursing, October 6 University, Egypt.'}, {'ForeName': 'Sandra Mohamed', 'Initials': 'SM', 'LastName': 'Ahmed', 'Affiliation': 'Department of Neurology, Department of Neurology, Faculty of Medicine, Cairo University.'}, {'ForeName': 'Sahar Mansour', 'Initials': 'SM', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Maternal and Newborn Health Nursing, Faculty of Nursing, Cairo University-Egypt.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2022.103694']
2856,35227528,Fatigue performance of endodontically treated molars restored with different dentin replacement materials.,"OBJECTIVES


The aim was to investigate the fatigue performance of endodontically treated (ET) molars restored by various dentin-replacing materials and material configurations. Moreover, the impact of additional adhesive treatment with glass-ionomer cement (GIC) was evaluated.
METHODS


250 intact molars were collected and randomly distributed into ten groups (n = 25). After endodontic procedure standard Class I cavities were prepared and restored with different direct restorative techniques and dentin-replacing materials. Two-group were restored with either packable or flowable short fiber-reinforced composites (SFRCs). Two-group were restored by experimental fiber-reinforced GIC with and without adhesive treatment. Four-group were restored by conventional and resin-modified GICs with or without adhesive treatment. One-group was restored with a dual-cure composite resin and last group was restored with only conventional composite resin (control). Fatigue-survival was measured for all specimens using a cyclic-loading machine until fracture occurred or a number of 40.000 cycles were achieved. Kaplan-Meyer survival analysis was conducted, followed by pairwise log-rank post hoc comparisons. Fracture mode was then examined by means of optical microscopy and SEM.
RESULTS


Group restored with flowable SFRC showed significantly higher survival (p < 0.05) compared to all of the groups, except for group restored with packable SFRC (p > 0.05). Group restored with fiber-reinforced GIC had significantly (p < 0.05) higher survival rates compared to other commercial GICs. SEM demonstrated change of the fracture line when fracture reached the SFRC layer.
SIGNIFICANCE


Direct restoration of Class I in ET molars with the use of SFRCs as dentin-replacing materials demonstrated its ability to reinforce the dental structures and to increase the fatigue resistance in this specific clinical situation.",2022,Group restored with fiber-reinforced GIC had significantly (p < 0.05) higher survival rates compared to other commercial GICs.,"['250 intact molars', 'Class I in ET molars with the use of SFRCs as dentin-replacing materials']","['packable or flowable short fiber-reinforced composites (SFRCs', 'dentin replacement materials', 'dual-cure composite resin and last group was restored with only conventional composite resin (control', 'conventional and resin-modified GICs with or without adhesive treatment', 'flowable SFRC', 'glass-ionomer cement (GIC']","['fatigue resistance', 'fatigue performance', 'survival rates', 'Fatigue-survival', 'survival', 'Fatigue performance']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",250.0,0.0353749,Group restored with fiber-reinforced GIC had significantly (p < 0.05) higher survival rates compared to other commercial GICs.,"[{'ForeName': 'Janka', 'Initials': 'J', 'LastName': 'Molnár', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Márk', 'Initials': 'M', 'LastName': 'Fráter', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Tekla', 'Initials': 'T', 'LastName': 'Sáry', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Braunitzer', 'Affiliation': 'dicomLAB Dental Ltd., Szeged, Hungary.'}, {'ForeName': 'Pekka K', 'Initials': 'PK', 'LastName': 'Vallittu', 'Affiliation': 'Department of Biomaterials Science and Turku Clinical Biomaterials Center -TCBC, Institute of Dentistry, University of Turku, Turku, Finland; City of Turku Welfare Division, Oral Health Care, Turku, Finland.'}, {'ForeName': 'Lippo', 'Initials': 'L', 'LastName': 'Lassila', 'Affiliation': 'Department of Biomaterials Science and Turku Clinical Biomaterials Center -TCBC, Institute of Dentistry, University of Turku, Turku, Finland.'}, {'ForeName': 'Sufyan', 'Initials': 'S', 'LastName': 'Garoushi', 'Affiliation': 'Department of Biomaterials Science and Turku Clinical Biomaterials Center -TCBC, Institute of Dentistry, University of Turku, Turku, Finland. Electronic address: sufgar@utu.fi.'}]",Dental materials : official publication of the Academy of Dental Materials,['10.1016/j.dental.2022.02.007']
2857,35227407,Eating Behavior-Choice or Reconstruction of Past Experience? A Randomized Clinical Trial of Changing Eating Intentions of Healthy Adults Through Hypnotic Suggestions.,"Recent meta-analyses have shown that psychological interventions have a small to medium effect on weight loss. We propose here a different approach to changing eating intentions. According to the Free Will literature, people decide to act before they acknowledge it, and they decide based on the reconstruction of previous experiences. The action can thus be inhibited immediately (max 100 ms) after awareness. We wanted to test if intervention based on this model, using hypnotic suggestions, can effectively change the intentions of eating. This study aims to identify which format of hypnotic suggestion can be more effective in changing eating intentions regarding high-calorie foods. Therefore, 88 healthy adult participants randomized in four groups received one session of hypnotic induction and suggestions or placebo. We measured the eating intentions through a computer task in which participants could choose pictures of low and high caloric food before, during, and after hypnosis. For the within-subject effect, results showed that two types of hypnotic suggestions significantly impacted the intentions of eating on high-calorie foods with large-effect, namely Cognitive Rehearsal (d = 0.81, p < .001) and Memory Substitution (d = 0.82, p < .001). After controlling for pretest ratings, we found a significant between-effect: the Cognitive Rehearsal group differed significantly from the Control in terms of intentions of eating (d = 0.85, p < .05). We conclude that hypnosis with Cognitive Rehearsal suggestions can help to positively impact the intentions of eating.",2022,"For the within-subject effect, results showed that two types of hypnotic suggestions significantly impacted the intentions of eating on high-calorie foods with large-effect, namely Cognitive Rehearsal (d ","['88 healthy adult participants', 'Healthy Adults']","['hypnosis with Cognitive Rehearsal suggestions', 'hypnotic induction and suggestions or placebo']","['eating intentions', 'weight loss', 'Memory Substitution ', 'intentions of eating']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",88.0,0.0209341,"For the within-subject effect, results showed that two types of hypnotic suggestions significantly impacted the intentions of eating on high-calorie foods with large-effect, namely Cognitive Rehearsal (d ","[{'ForeName': 'Loana T', 'Initials': 'LT', 'LastName': 'Comșa', 'Affiliation': 'Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Oana A', 'Initials': 'OA', 'LastName': 'David', 'Affiliation': 'Babes-Bolyai University, Cluj-Napoca, Romania. Electronic address: oanadavid@psychology.ro.'}, {'ForeName': 'Daniel O', 'Initials': 'DO', 'LastName': 'David', 'Affiliation': 'Babes-Bolyai University, Cluj-Napoca, Romania.'}]",Behavior therapy,['10.1016/j.beth.2021.09.005']
2858,35227405,Feasibility and Acceptability of Cognitive Bias Modification for Interpretation as an Adjunctive Treatment for OCD and Related Disorders: A Pilot Randomized Controlled Trial.,"Cognitive models implicate interpretation bias in the development and maintenance of obsessive compulsive and related disorders (OCRDs), and research supports Cognitive Bias Modification for Interpretation (CBM-I) in targeting this mechanism. However, prior studies in OCRDs have been limited to nonclinical populations, adolescents, and adults in a laboratory setting. This study evaluated the feasibility and acceptability of CBM-I as an adjunctive intervention during intensive/residential treatment (IRT) for adults with OCRDs. We modified a lab-based CBM-I training for adults seeking IRT for OCRDs, and conducted a feasibility trial (N = 4) and subsequent pilot RCT; participants (N = 31) were randomized to receive CBM-I or psychoeducation. Benchmarks were met for feasibility, acceptability, and target engagement. From pre- to post-intervention, the CBM-I group showed a large effect for change in interpretation bias (d = .90), whereas this effect was trivial (d = .06) for psychoeducation. This was the first study to evaluate CBM-I in naturalistic treatment for adults seeking IRT for OCRDs. Findings support the feasibility and acceptability of CBM-I in this novel sample and setting. A larger scale RCT is needed to determine whether CBM-I can enhance OCRD treatment response.",2022,"From pre- to post-intervention, the CBM-I group showed a large effect for change in interpretation bias (d = .90), whereas this effect was trivial (d = .06) for psychoeducation.","['OCD and Related Disorders', 'adults seeking IRT for OCRDs', 'adults seeking IRT for OCRDs, and conducted a feasibility trial (N\u202f=\u202f4) and subsequent pilot RCT; participants (N\u202f=\u202f31', 'adults with OCRDs']","['CBM-I or psychoeducation', 'lab-based CBM-I training']",[],"[{'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035189', 'cui_str': 'Residential Treatment'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}]","[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],31.0,0.0913806,"From pre- to post-intervention, the CBM-I group showed a large effect for change in interpretation bias (d = .90), whereas this effect was trivial (d = .06) for psychoeducation.","[{'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Falkenstein', 'Affiliation': 'McLean Hospital/Harvard Medical School. Electronic address: mfalkenstein@mclean.harvard.edu.'}, {'ForeName': 'Kara N', 'Initials': 'KN', 'LastName': 'Kelley', 'Affiliation': 'McLean Hospital/Harvard Medical School.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Dattolico', 'Affiliation': 'McLean Hospital/Harvard Medical School.'}, {'ForeName': 'Jennie M', 'Initials': 'JM', 'LastName': 'Kuckertz', 'Affiliation': 'McLean Hospital/Harvard Medical School.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bezahler', 'Affiliation': 'McLean Hospital/Harvard Medical School.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Krompinger', 'Affiliation': 'McLean Hospital/Harvard Medical School.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Webb', 'Affiliation': 'McLean Hospital/Harvard Medical School.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Beard', 'Affiliation': 'McLean Hospital/Harvard Medical School.'}]",Behavior therapy,['10.1016/j.beth.2021.09.002']
2859,35227404,Combined Emotional Socialization Training and Family Accommodation Modification: Impact on Emotional Regulation and Anxiety Symptoms in Anxious Children.,"Past studies show that emotional socialization and family accommodation are involved in children's anxiety, but research has yet to investigate whether targeting emotional socialization training (EST), family accommodation modification (FAM), or EST and FAM in tandem can reduce anxiety in children. The purpose of this study was to evaluate the efficacy of a combination of EST and FAM on improving emotion regulation (ER) and reducing anxiety symptoms in anxious children. The sample consisted of 80 children with an anxiety disorder (M age  = 6.7, SD = 0.1) and their mothers. Mothers were randomly assigned to an EST (n = 17), FAM (n = 16), Combined (n = 17), or a waitlist control (WLC) (n = 16) groups. Mothers completed The Emotion Regulation Checklist (ERC) and Spence Children's Anxiety Scale (SCAS) at pre-test, post-test, and at 6-month of follow-up. The results showed that the EST, FAM, and Combined groups were more effective than WLC in improving ER and reducing anxiety severity at post-test and follow-up. Among the intervention groups, children in the combined group showed greater reductions in the severity of anxiety symptoms and emotion dysregulation than the other two groups. Assisting parents to use strategies that encourage healthy emotion regulation and decrease family accommodation might help reduce the severity of children's anxiety symptoms.",2022,"Among the intervention groups, children in the combined group showed greater reductions in the severity of anxiety symptoms and emotion dysregulation than the other two groups.","['80 children with an anxiety disorder (M age  = 6.7, SD = 0.1) and their mothers', 'children', 'Anxious Children', 'anxious children']","['EST, FAM', 'waitlist control (WLC', 'WLC', 'FAM', 'EST and FAM', 'Combined Emotional Socialization Training and Family Accommodation Modification', 'EST']","['severity of anxiety symptoms and emotion dysregulation', 'emotion regulation (ER', 'anxiety symptoms', ""Emotion Regulation Checklist (ERC) and Spence Children's Anxiety Scale (SCAS"", 'Emotional Regulation and Anxiety Symptoms', 'ER and reducing anxiety severity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}]",80.0,0.0250533,"Among the intervention groups, children in the combined group showed greater reductions in the severity of anxiety symptoms and emotion dysregulation than the other two groups.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Hassanzadeh-Avval', 'Affiliation': 'Ferdowsi University of Mashhad.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mashhadi', 'Affiliation': 'Ferdowsi University of Mashhad. Electronic address: mashhadi@um.ac.ir.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Suveg', 'Affiliation': 'University of Georgia, Athens.'}, {'ForeName': 'Imanollah', 'Initials': 'I', 'LastName': 'Bigdeli', 'Affiliation': 'Ferdowsi University of Mashhad.'}, {'ForeName': 'Seyed Amir', 'Initials': 'SA', 'LastName': 'Amin Yazdi', 'Affiliation': 'Ferdowsi University of Mashhad.'}, {'ForeName': 'Mahdi Abdollahzadeh', 'Initials': 'MA', 'LastName': 'Rafi', 'Affiliation': 'Malayer University.'}]",Behavior therapy,['10.1016/j.beth.2021.09.003']
2860,35227402,Sudden Gains in Two Trauma-Focused Treatments for Posttraumatic Stress Disorder.,"In the current study, we examined the degree to which sudden gains (large, rapid, and stable symptom reduction in a one-session interval) predicted treatment outcome in adults randomized to two different trauma-focused treatments. Adults diagnosed with PTSD were randomized to either written exposure therapy (WET; n = 63), a brief, exposure-based treatment for posttraumatic stress disorder (PTSD), or the more time-intensive Cognitive Processing Therapy (CPT; n = 63). Findings showed that 20.6% of participants who received WET and 17.5% of participants who received CPT experienced sudden gains. Sudden gains occurred earlier in WET (M session = 2.69, SD = 0.75) than in CPT (M session = 5.64, SD = 3.01). However, there were no treatment condition differences in the magnitude of the sudden gains. Treatment outcomes were significantly better for those who experienced sudden gains compared with those who did not, regardless of treatment assignment. Exploratory analyses of participants' trauma narratives revealed that expressing more negative emotion predicted the occurrence of sudden gains in both treatment conditions. Negative beliefs about the self and others did not predict sudden gains. The findings are discussed in terms of how they may help identify individual early response patterns that predict outcomes in trauma-focused treatments.",2022,Exploratory analyses of participants' trauma narratives revealed that expressing more negative emotion predicted the occurrence of sudden gains in both treatment conditions.,"[""participants' trauma narratives"", 'Adults diagnosed with PTSD']","['written exposure therapy', 'brief, exposure-based treatment for posttraumatic stress disorder (PTSD), or the more time-intensive Cognitive Processing Therapy (CPT']","['sudden gains', 'Sudden gains']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1276802', 'cui_str': 'Sudden'}]",63.0,0.0645968,Exploratory analyses of participants' trauma narratives revealed that expressing more negative emotion predicted the occurrence of sudden gains in both treatment conditions.,"[{'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Sloan', 'Affiliation': 'VA Boston Healthcare System; Boston University School of Medicine; National Center for PTSD. Electronic address: Denise.Sloan@va.gov.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Thompson-Hollands', 'Affiliation': 'VA Boston Healthcare System; Boston University School of Medicine; National Center for PTSD.'}, {'ForeName': 'Adele M', 'Initials': 'AM', 'LastName': 'Hayes', 'Affiliation': 'University of Delaware.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lee', 'Affiliation': 'VA Boston Healthcare System; Boston University School of Medicine; National Center for PTSD.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Alpert', 'Affiliation': 'University of Delaware.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Marx', 'Affiliation': 'VA Boston Healthcare System; Boston University School of Medicine; National Center for PTSD.'}]",Behavior therapy,['10.1016/j.beth.2021.08.003']
2861,35227669,Interdisciplinary Protocol for Surgery in Older Persons: Development and Implementation.,"As the population ages, more older adults will undergo surgical procedures, and common physiologic changes can raise the risk for surgical complications while increasing morbidity and mortality. In conjunction with the National Surgical Quality Improvement Program, we piloted a comprehensive and interdisciplinary assessment and intervention protocol for perioperative care for patients aged ≥75 years undergoing elective general, gynecology-oncologic, and orthopedic surgery. The intervention included screening tools for cognitive, functional, and nutritional deficits, a Geriatric Nurse Champion on each inpatient surgical unit, and an interdisciplinary Geriatric Surgery Quality Committee. Our intervention group was compared to surgical patients during the same time period 1 year prior to the intervention, and the groups were well matched in demographics and comorbidities. The intervention group had significantly higher rates of advance care plan documentation in analysis of all patients (P < .001) and in subgroup analysis of those 85 and older (P = .006). The preintervention group had less postoperative delirium compared to the postintervention group but it was not significant and there was no difference in length of stay between groups. Various explanations for the minimal impact of the protocol exist: small sample size, presence of other hospital initiatives to reduce pressure ulcer and delirium, and clinician's awareness of project planning that led to incorporating ideas prior to official implementation. Future research implementing this protocol in naïve and/or underperforming institutions may demonstrate a greater effect. Larger sample size as well as implementation in other surgical fields may reveal a significant impact. However, if additional study does not reveal a meaningful impact of a comprehensive geriatric assessment for surgical patients, then consideration must be made regarding unrecognized factors in surgical care for older adults or perhaps that factors cannot be mitigated in older adults because they are intrinsically a higher surgical risk.",2022,The intervention group had significantly higher rates of advance care plan documentation in analysis of all patients (P < .001) and in subgroup analysis of those 85 and older (P = .006).,"['Older Persons', 'patients aged ≥75\xa0years undergoing elective general, gynecology-oncologic, and orthopedic surgery']",['comprehensive and interdisciplinary assessment and intervention protocol'],"['postoperative delirium', 'rates of advance care plan documentation', 'length of stay']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C4544311', 'cui_str': 'Advance care plan'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0321403,The intervention group had significantly higher rates of advance care plan documentation in analysis of all patients (P < .001) and in subgroup analysis of those 85 and older (P = .006).,"[{'ForeName': 'Paula E', 'Initials': 'PE', 'LastName': 'Lester', 'Affiliation': 'NYU Long Island School of Medicine, Mineola, NY, USA. Electronic address: Paula.Lester@nyulangone.org.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Ripley', 'Affiliation': 'NYU Langone-Long Island Hospital, Mineola, NY, USA.'}, {'ForeName': 'Roseann', 'Initials': 'R', 'LastName': 'Grandelli', 'Affiliation': 'NYU Langone-Long Island Hospital, Mineola, NY, USA.'}, {'ForeName': 'Linnea A', 'Initials': 'LA', 'LastName': 'Drew', 'Affiliation': 'NYU Langone-Long Island Hospital, Mineola, NY, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Keegan', 'Affiliation': 'NYU Langone-Long Island Hospital, Mineola, NY, USA.'}, {'ForeName': 'Shahidul', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'NYU Long Island School of Medicine, Mineola, NY, USA.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2022.01.070']
2862,35227659,Estimation of body fat in children with intellectual disability: development and cross-validation of a simple anthropometric method.,"OBJECTIVE


Population-level monitoring of body composition requires accurate, biologically-relevant, yet feasible methods for estimating percent body fat (%BF). The aim of this study was to develop and cross-validate an equation for %BF from Body Mass Index (BMI), age, and sex among children with intellectual disability (ID). This study further aimed to examine the performance of an existing BMI-based equation (Deurenberg equation) for %BF in children with ID.
METHOD


Participants were 107 children (63 boys; aged 6-15 years) with ID randomly allocated to development (n = 81) and cross-validation (n = 26) samples. Dual-Energy X-Ray Absorptiometry provided the criterion %BF.
RESULTS


The model including BMI, age, and sex (0 = male; 1 = female) had a significant goodness-of-fit in determining %BF (p < 0.001; R 2  = 0.69; SEE =5.68%). The equation was: %BF = - 15.416 + (1.394 × BMI) + (4.538 × age) - (0.262 × age 2 ) + (5.489 × sex). The equation was cross-validated in the separate sample based on (i) strong correlation (r = 0.82; p < 0.001) and non-significant differences between actual and predicted %BF (28.6 ± 9.6% and 30.1 ± 7.1%, respectively); (ii) mean absolute error (MAE) = 4.4%; and (iii) reasonable %BF estimations in Bland-Altman plot (mean: 1.48%; 95% CI: 12.5, -9.6). The Deurenberg equation had a large %BF underestimation (mean: -7.1%; 95% CI: 5.3, -19.5), significant difference between actual and estimated %BF (28.6 ± 9.7% and 21.5 ± 7.0%, respectively; p < 0.001), and MAE = 8.1%.
CONCLUSIONS


The developed equation with BMI, sex, and age provides valid %BF estimates for facilitating population-level body fat screening among children with ID.",2022,"-7.1%; 95% CI: 5.3, -19.5), significant difference between actual and estimated %BF (28.6 ± 9.7% and 21.5 ± 7.0%, respectively; p < 0.001), and MAE = 8.1%.
","['Participants were 107 children (63 boys; aged 6-15 years) with ID randomly allocated to development (n\xa0=\xa081) and cross-validation (n\u202f=\u202f26) samples', 'children with ID', 'children with intellectual disability', 'children with intellectual disability (ID']",['existing BMI-based equation (Deurenberg equation'],[],"[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],107.0,0.0258214,"-7.1%; 95% CI: 5.3, -19.5), significant difference between actual and estimated %BF (28.6 ± 9.7% and 21.5 ± 7.0%, respectively; p < 0.001), and MAE = 8.1%.
","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Bertapelli', 'Affiliation': 'Universidade de Campinas (Unicamp), Faculdade de Ciências Médicas, Campinas, SP, Brazil. Electronic address: fbertapelli@gmail.com.'}, {'ForeName': 'Stamatis', 'Initials': 'S', 'LastName': 'Agiovlasitis', 'Affiliation': 'Mississippi State University, Department of Kinesiology, Starkville, United States.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'University of Alabama at Birmingham, Department of Physical Therapy, BM, United States.'}, {'ForeName': 'Marcos M', 'Initials': 'MM', 'LastName': 'de Barros-Filho', 'Affiliation': 'Universidade de Campinas (Unicamp), Faculdade de Ciências Médicas, Campinas, SP, Brazil.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Guerra-Junior', 'Affiliation': 'Universidade de Campinas (Unicamp), Faculdade de Ciências Médicas, Campinas, SP, Brazil.'}]",Jornal de pediatria,['10.1016/j.jped.2022.01.003']
2863,35227647,"AZD5634, an inhaled ENaC inhibitor, in healthy subjects and patients with cystic fibrosis.","BACKGROUND


Epithelial sodium channel (ENaC) inhibitors may offer clinical benefit in cystic fibrosis (CF); however, data are limited. We report the outcomes of a Phase I (NCT02679729) and a Phase Ib (NCT02950805) study of AZD5634, a novel inhaled ENaC inhibitor.
METHODS


A Phase I, first-in-human, single-blind, placebo-controlled, single ascending dose, sequential dose group study assessed the safety, tolerability, and pharmacokinetics of AZD5634 in healthy subjects (n=53) in part A following inhaled doses up to 1700 µg, and, in part B, following administration of single inhaled (1700 µg) and intravenous (65 µg) doses. A Phase Ib, randomized, double-blind, placebo-controlled, single-dose, 2-way cross-over study assessed the effects of a single dose (600 µg) of inhaled AZD5634 on mucociliary clearance (MCC), pharmacokinetics and safety and tolerability in patients with CF (n=11). Nasal potential difference (NPD) was assessed as an in situ target engagement exploratory biomarker.
RESULTS


Absolute bioavailability of AZD5634 after inhalation was approximately 3%, indicating minimal distribution into the systemic circulation. Urinary excretion was a minor elimination pathway. Administration of inhaled AZD5634 did not improve MCC in CF patients, but AZD5634 inhibited ENaC in the nasal epithelium, as measured by NPD. AZD5634 was safe and well tolerated in both studies.
CONCLUSIONS


AZD5634 showed favorable pharmacokinetics and safety in healthy subjects and patients with CF. However, despite achieving target engagement, proof of mechanism was not achieved after a single dose in patients with CF. Further evaluation into multiple dose studies is warranted to explore its therapeutic potential.",2022,"Administration of inhaled AZD5634 did not improve MCC in CF patients, but AZD5634 inhibited ENaC in the nasal epithelium, as measured by NPD.","['healthy subjects (n=53', 'healthy subjects and patients with CF', 'cystic fibrosis (CF', 'patients with CF (n=11', 'healthy subjects and patients with cystic fibrosis']","['inhaled AZD5634', 'Epithelial sodium channel (ENaC) inhibitors', 'AZD5634', 'placebo']","['MCC', 'safety, tolerability, and pharmacokinetics of AZD5634', 'mucociliary clearance (MCC), pharmacokinetics and safety and tolerability', 'Nasal potential difference (NPD', 'Urinary excretion', 'favorable pharmacokinetics and safety', 'safe and well tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C3494352', 'cui_str': 'Epithelial Sodium Channel Antagonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",,0.162308,"Administration of inhaled AZD5634 did not improve MCC in CF patients, but AZD5634 inhibited ENaC in the nasal epithelium, as measured by NPD.","[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Kristensson', 'Affiliation': 'Early Respiratory & Immunology Early Clinical Development, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Åstrand', 'Affiliation': 'Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden. Electronic address: Annika.Astrand@astrazeneca.com.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Donaldson', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Goldwater', 'Affiliation': 'Parexel International, Baltimore, MD, USA.'}, {'ForeName': 'Raolat', 'Initials': 'R', 'LastName': 'Abdulai', 'Affiliation': 'Sanofi US, Cambridge, MA, USA.'}, {'ForeName': 'Naimish', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Sanofi US, Cambridge, MA, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Gardiner', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Tehler', 'Affiliation': 'Advanced Drug Delivery, Pharmaceutical Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anne-Kristina', 'Initials': 'AK', 'LastName': 'Mercier', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Olsson', 'Affiliation': 'Data Science and AI, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ersdal', 'Affiliation': 'Early Respiratory & Immunology Early Clinical Development, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Mäenpää', 'Affiliation': 'Patient Safety, Respiratory & Immunology, Chief Medical Office, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Bramer', 'Affiliation': 'Inhalation Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Malmgren', 'Affiliation': 'Early Respiratory & Immunology Early Clinical Development, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Bennett', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Keen', 'Affiliation': 'Early Respiratory & Immunology Early Clinical Development, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Early Respiratory & Immunology Projects, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2022.02.010']
2864,35227641,"Response to letter to the editor regarding ""The effects of combined sternocleidomastoid muscle stretching and massage on pain, disability, endurance, kinesiophobia, and range of motion in individuals with chronic neck pain: A randomized, single blind-study"".",,2022,,['individuals with chronic neck pain'],['combined sternocleidomastoid muscle stretching and massage'],"['pain, disability, endurance, kinesiophobia, and range of motion']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",,0.0399986,,"[{'ForeName': 'Buket', 'Initials': 'B', 'LastName': 'Büyükturan', 'Affiliation': 'Kırşehir Ahi Evran University, Schol of Physical Therapy and Rehabilitation, Kırşehir, Turkey. Electronic address: fztkaya04@hotmail.com.'}, {'ForeName': 'Senem', 'Initials': 'S', 'LastName': 'Şaş', 'Affiliation': 'Erciyes University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Division of Rheumatology, Kayseri, Turkey. Electronic address: senemsas@gmail.com.'}, {'ForeName': 'Caner', 'Initials': 'C', 'LastName': 'Kararti', 'Affiliation': 'Kırşehir Ahi Evran University, Schol of Physical Therapy and Rehabilitation, Kırşehir, Turkey. Electronic address: fzt.caner.92@gmail.com.'}, {'ForeName': 'Öznur', 'Initials': 'Ö', 'LastName': 'Büyükturan', 'Affiliation': 'Kırşehir Ahi Evran University, Schol of Physical Therapy and Rehabilitation, Kırşehir, Turkey. Electronic address: fzt_oznur@hotmail.com.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2022.102528']
2865,35227636,Risk communication in acute stroke patients - from qualitative data to a pilot randomised controlled trial.,"OBJECTIVES


The probability of recurring strokes in patients with atrial fibrillation is high. Within 1.8 years, 6.6 % of the patients suffered a new stroke. While effective secondary prevention options exist, low adherence challenges effective medical treatment. The aim of our study was to examine the risk understanding of acute stroke patients and to find the best way to communicate risk reduction.
MATERIALS AND METHODS


Risk communication had three formats: a text, a pictogram, and a cube diagram. All three were developed on the basis of the criteria of evidence-based patient information. Patients who were admitted to the stroke unit and diagnosed with acute stroke, assessed the information material. Data on secondary prevention using acetylsalicylic acid were taken as an example, with no reference to actual patient treatment. In a first step, we interviewed a focus group to check the feasibility of the questionnaire (qualitative study). In the second step, the information material was tested in a pilot randomized controlled trial.
RESULTS


Acute stroke patients (qualitative study, n=13) understood the information and were interested in numerical risk communication. The visualized representations were superior in terms of understandability of the numbers communicated (pilot randomized controlled trial, n=60, 50 % correct answers for question 1, p value of 0.502, and 55 % correct answers for question 2, p value of 0.338). Stroke-related neurologic deficits, measured with the National Institute of Health Stroke Scale (NIHSS) on admission, revealed a significant influence on the number of correct answers to stroke risk questions, whereas the type of stroke and education did not.
CONCLUSIONS


Acute stroke patients were able to understand risk communication. Visualization helped them capture information on stroke risk.",2022,"The visualized representations were superior in terms of understandability of the numbers communicated (pilot randomized controlled trial, n=60, 50 % correct answers for question 1, p value of 0.502, and 55 % correct answers for question 2, p value of 0.338).","['acute stroke patients', 'Acute stroke patients', 'Patients who were admitted to the stroke unit and diagnosed with acute stroke, assessed the information material', 'patients with atrial fibrillation']",['acetylsalicylic acid'],"['probability of recurring strokes', 'National Institute of Health Stroke Scale (NIHSS']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",13.0,0.0486801,"The visualized representations were superior in terms of understandability of the numbers communicated (pilot randomized controlled trial, n=60, 50 % correct answers for question 1, p value of 0.502, and 55 % correct answers for question 2, p value of 0.338).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Artmann', 'Affiliation': 'Department of Neurology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany. Electronic address: Anna_artmann@icloud.com.'}, {'ForeName': 'Anne Christin', 'Initials': 'AC', 'LastName': 'Rahn', 'Affiliation': 'Institute of Social Medicine & Epidemiology, Nursing Research Unit, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Köpke', 'Affiliation': 'Institute of Social Medicine & Epidemiology, Nursing Research Unit, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Thomalla', 'Affiliation': 'Department of Neurology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heesen', 'Affiliation': 'Department of Neurology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany; Institut for Neuroimmunology und Multiple Sklerosis, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anna Christina', 'Initials': 'AC', 'LastName': 'Alegiani', 'Affiliation': 'Department of Neurology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany; Asklepsios Klinik Altona, Hamburg, Germany.'}]","Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen",['10.1016/j.zefq.2022.01.001']
2866,35228081,Clinical moderators of response to nalmefene in a randomized-controlled trial for alcohol dependence: An exploratory analysis.,"BACKGROUND


Nalmefene is the only medication marketed to reduce the consumption of alcohol in patients with alcohol dependence, but it remains unclear which patients could most benefit from it. This study aimed to identify clinical moderators that affect treatment response to nalmefene in patients with alcohol dependence.
METHODS


In a multicenter, randomized, controlled, double-blind, phase 3 study of nalmefene on Japanese patients with alcohol dependence, the relationship between the reduction of heavy drinking days (HDD) and total alcohol consumption (TAC) at 12 and 24 weeks of treatment and baseline variables of the participants were analyzed in a linear regression and multiple adjusted analysis.
RESULTS


Age < 65, no family history of problem drinking, age at onset of problem drinking ≥ 25, and not currently smoking were possible positive moderators. Nalmefene showed a significant HDD reduction in patients with age < 65 or no family history of problem drinking, and a significant TAC reduction in patients with age at onset of problem drinking ≥ 25 or who were not currently smoking. After multiple adjusted analyses, age < 65 (p = .028), no family history of problem drinking (p = .047), and age at onset of problem drinking ≥ 25 (p = .030) were statistically significant. Not currently smoking (p = .071) was marginally significant. In combination, these moderators indicated synergistic effects.
CONCLUSIONS


Alcohol-dependent patients with favorable prognostic factors such as non-smoking status, no family history of problem drinking, and a late-onset of problem drinking selectively benefit from nalmefene. Further research is needed to validate these exploratory results.",2022,"Nalmefene showed a significant HDD reduction in patients with age < 65 or no family history of problem drinking, and a significant TAC reduction in patients with age at onset of problem drinking ≥ 25 or who were not currently smoking.","['patients with alcohol dependence', 'Japanese patients with alcohol dependence', 'Age']",[],"['no family history of problem drinking', 'HDD reduction', 'heavy drinking days (HDD) and total alcohol consumption (TAC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0332123', 'cui_str': 'No family history of'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0792917,"Nalmefene showed a significant HDD reduction in patients with age < 65 or no family history of problem drinking, and a significant TAC reduction in patients with age at onset of problem drinking ≥ 25 or who were not currently smoking.","[{'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Japan; Okayama Psychiatric Medical Center, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Habu', 'Affiliation': 'Department of Epidemiology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Japan.'}, {'ForeName': 'Soshi', 'Initials': 'S', 'LastName': 'Takao', 'Affiliation': 'Department of Epidemiology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Okahisa', 'Affiliation': 'Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Japan.'}, {'ForeName': 'Keitaro', 'Initials': 'K', 'LastName': 'Matsuo', 'Affiliation': 'Division of Cancer Epidemiology and Prevention, Aichi Cancer Center Research Institute, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Takaki', 'Affiliation': 'Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Japan. Electronic address: manabuta@cc.okayama-u.ac.jp.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Kishi', 'Affiliation': 'Okayama Psychiatric Medical Center, Japan.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Yamada', 'Affiliation': 'Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Japan.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2022.109365']
2867,35228846,"Effects of low-volume, high-intensity interval training on maximal oxygen consumption, body fat percentage and health-related quality of life in women with overweight: A randomized controlled trial.","Background


Several investigations suggest that high-intensity interval training (HIIT) provokes larger changes in VO 2max  compared to moderate-intensity continuous training (MICT); other studies associate HIIT with significant decreases in total, abdominal and visceral fat mass. However, some meta-analyses express that the enhancements with HIIT on VO 2max  are slightly higher concerning MICT. These studies had low-to-moderate methodological quality, and the exercise protocols were completed mostly on treadmills or cycle ergometers. Thus, the objective of this study was to compare the effect of a low-volume HIIT versus a MICT program on VO 2max , body fat percentage (BFP), and health-related quality of life (HRQoL) in overweight women. It followed a research protocol with high methodological rigor and good reporting quality.
Methods


After two physical adaptation weeks (run-in period), thirty-five volunteers were randomized to HIIT (n = 16) or MICT (n = 19). Both groups performed 24 sessions on a grass sports field (walking, jogging or running). The HIIT group completed 15 bouts of 30 s [90-95%, maximal heart rate (HR max )], while the MICT group completed 30 min of continuous exercise (65-75% HR max ).
Results


The difference between HIIT and MICT post-intervention on VO 2max  was not statistically significant (0.8 ml/kg/min. CI 95%, -1.0 to 2.7, p = 0.37). Similarly, no statistically significant differences were found between groups for BFP and HRQoL.
Conclusions


Low-volume HIIT program has no quantitative advantage compared with that resulting from MICT, in VO2max, BFP, and HRQoL. ClinicalTrials.gov Identifier: NCT03300895.",2022,The difference between HIIT and MICT post-intervention on VO 2max  was not statistically significant (0.8 ml/kg/min.,"['women with overweight', 'overweight women']","['low-volume HIIT versus a MICT program', 'grass sports field (walking, jogging or running', 'MICT group completed 30\xa0min of continuous exercise', 'low-volume, high-intensity interval training', 'MICT']","['VO 2max , body fat percentage (BFP), and health-related quality of life (HRQoL', 'maximal oxygen consumption, body fat percentage and health-related quality of life', 'maximal heart rate (HR max ', 'total, abdominal and visceral fat mass', 'VO 2max']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018210', 'cui_str': 'Poaceae'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0022400', 'cui_str': 'Jogging'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",35.0,0.0174459,The difference between HIIT and MICT post-intervention on VO 2max  was not statistically significant (0.8 ml/kg/min.,"[{'ForeName': 'Víctor H', 'Initials': 'VH', 'LastName': 'Arboleda-Serna', 'Affiliation': 'Research Group on Physical Activity for Health (AFIS, in Spanish), University Institute of Physical Education and Sports, The University of Antioquia, Medellín, Colombia.'}, {'ForeName': 'Fredy A', 'Initials': 'FA', 'LastName': 'Patiño-Villada', 'Affiliation': 'Research Group on Physical Activity for Health (AFIS, in Spanish), University Institute of Physical Education and Sports, The University of Antioquia, Medellín, Colombia.'}, {'ForeName': 'Deiber A', 'Initials': 'DA', 'LastName': 'Pinzón-Castro', 'Affiliation': 'Research Group on Physical Activity for Health (AFIS, in Spanish), University Institute of Physical Education and Sports, The University of Antioquia, Medellín, Colombia.'}, {'ForeName': 'Elkin F', 'Initials': 'EF', 'LastName': 'Arango-Vélez', 'Affiliation': 'Research Group on Physical Activity for Health (AFIS, in Spanish), University Institute of Physical Education and Sports, The University of Antioquia, Medellín, Colombia.'}]",Journal of exercise science and fitness,['10.1016/j.jesf.2022.01.004']
2868,35228834,A Brief Gratitude Writing Intervention Decreased Stress and Negative Affect During the COVID-19 Pandemic.,Exploring ways to mitigate the stress of the COVID-19 pandemic is important for long-term health. Expressive and gratitude-focused writing are effective methods to help individuals process traumatic or stressful events. Gratitude-focused writing may yield additional benefits because it helps individuals appraise events positively. We hypothesized that an online gratitude writing intervention would yield greater benefits than an expressive writing intervention or control group. Participants were randomized to one of three groups and completed assessments one-week and one-month post-intervention. The gratitude writing group maintained gratitude levels and decreased stress and negative affect at one-month post-intervention. The expressive writing group decreased in gratitude and showed no changes in stress or negative affect at one-month post-intervention. The control group decreased in gratitude and negative affect and showed no changes in stress at one-month post-intervention. Gratitude writing may be a better resource for dealing with stress and negative affect than traditional expressive writing methods under extremely stressful situations with uncertain trajectories.,2022,The expressive writing group decreased in gratitude and showed no changes in stress or negative affect at one-month post-intervention.,[],[],"['stress or negative affect', 'stress', 'Stress and Negative Affect']",[],[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",,0.0419004,The expressive writing group decreased in gratitude and showed no changes in stress or negative affect at one-month post-intervention.,"[{'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Fekete', 'Affiliation': 'Department of Psychological Sciences, University of Indianapolis, Indianapolis, IN 46227 USA.'}, {'ForeName': 'Nathan T', 'Initials': 'NT', 'LastName': 'Deichert', 'Affiliation': 'Department of Psychology, Black Hills State University, Spearfish, 57799 USA.'}]",Journal of happiness studies,['10.1007/s10902-022-00505-6']
2869,35228783,"An open-labelled, randomised, controlled, proof of concept clinical trial to evaluate the efficacy of AYUSH interventions (Cap.Torchnil + Tab. Febcin) as add-on therapy in the clinical management of moderate Covid-19 patients.","Background


The COVID-19 pandemic is the latest public health crisis that is threatening the world and till date, there is no evidence of any effective treatment for COVID-19. The Department of AYUSH is taking efforts to find effective herbal Ayurvedic medicines for both preventive and therapeutic management.
Objectives


This clinical study was conducted to evaluate the efficacy and safety of 2 AYUSH interventions (Cap.Torchnil + Tab. Febcin) when given as add-on therapy in the clinical management of Covid19 positive patients with moderate disease.
Material and Methods


This open-labelled, randomised, controlled, comparative proof-of-concept clinical study was conducted in a dedicated Covid hospital in patients admitted with COVID19 disease of moderate severity. Following written informed consent, patients were randomised to receive either study medications (Cap.Torchnil- 1 capsule thrice daily & Tab.Febcin- 1 tablet 4 times daily) in addition to standard of care (SOC) [Add-on Group] or only SOC [SOC Group] for 14 days. Effect on clinical symptoms, WHO Clinical Assessment scale, duration of hospital stay, time to RT-PCR negative report, need for supplemental oxygen, effect on biomarkers were assessed during admission and relapse rate, if any, post discharge for total of 3 months. Safety assessment was done both clinically & using laboratory parameters  viz.  haematology & biochemical tests.
Results


193 patients were screened while 150 completed the study, 77 in Add-on Group and 73 in SOC Group. Covid related symptoms, especially headache and dry cough improved earlier in Add-on Group as compared to SOC Group which was statistically significant. Improvement in WHO Assessment scale, time to covid negative report and duration of hospital stay was earlier in Add-on Group (at day 7). Although improvement in serum biomarker levels was seen in both groups, a statistically significant fall was observed in Add-on Group for CPK, D-dimer and IL-6 values at Day 14 and LDH levels at Days 7 & 14. Improvement in Sp0 2  and oxygen requirements was also seen earlier in Add-on Group as compared to SOC Group. No major adverse effects were observed in both groups except 2 patients who complained of hyperacidity in Add-on Group. Post discharge, 49 patients from Add-on Group and 42 patients from SOC Group came for physical visits. All these patients were clinically stable with no worsening of their clinical condition and no signs or symptoms suggestive of a repeat Covid infection. Their vital signs and Sp0 2  levels were within the normal range in both groups.
Conclusion


The study results thus showed that a combination of Cap. Torchnil and Tab. Febcin was effective and safe when given as an add-on therapy to SOC in the clinical management of patients with moderate COVID-19 disease.",2022,All these patients were clinically stable with no worsening of their clinical condition and no signs or symptoms suggestive of a repeat Covid infection.,"['49 patients from Add-on Group and 42 patients from SOC Group came for physical visits', 'moderate Covid-19 patients', 'Covid19 positive patients with moderate disease', 'patients admitted with COVID19 disease of moderate severity', '193 patients were screened while 150 completed the study, 77 in Add-on Group and 73 in SOC Group', 'patients with moderate COVID-19 disease']","['AYUSH interventions (Cap', 'Febcin- 1', 'Torchnil', '2 AYUSH interventions (Cap', 'standard of care (SOC', 'Torchnil + Tab']","['WHO Assessment scale, time to covid negative report and duration of hospital stay', 'clinical symptoms, WHO Clinical Assessment scale, duration of hospital stay, time to RT-PCR negative report, need for supplemental oxygen, effect on biomarkers', 'headache and dry cough', 'adverse effects', 'efficacy and safety', 'serum biomarker levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0850149', 'cui_str': 'Dry cough'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",193.0,0.016072,All these patients were clinically stable with no worsening of their clinical condition and no signs or symptoms suggestive of a repeat Covid infection.,"[{'ForeName': 'Renuka', 'Initials': 'R', 'LastName': 'Munshi', 'Affiliation': 'Department of Clinical Pharmacology, TN Medical College & BYL Nair Hospital, Mumbai Central, Mumbai, Maharashtra 400008, India.'}, {'ForeName': 'Dipti', 'Initials': 'D', 'LastName': 'Kumbhar', 'Affiliation': 'Department of Clinical Pharmacology, TN Medical College & BYL Nair Hospital, Mumbai Central, Mumbai, Maharashtra 400008, India.'}, {'ForeName': 'Pranesh', 'Initials': 'P', 'LastName': 'Pawaskar', 'Affiliation': 'Department of Clinical Pharmacology, TN Medical College & BYL Nair Hospital, Mumbai Central, Mumbai, Maharashtra 400008, India.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Rajadakshya', 'Affiliation': 'Department of Medicine, TN Medical College & BYL Nair Hospital, Mumbai Central, Mumbai, Maharashtra 400008, India.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Palep', 'Affiliation': ""DR. Palep's Medical Research Foundation Private Limited, Lower Parel West, Mumbai, Maharashtra 400013, India.""}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2022.100559']
2870,35228755,Nivolumab plus ipilimumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial.,"Previous studies have suggested that the gut microbiome influences the response to checkpoint inhibitors (CPIs) in patients with cancer. CBM588 is a bifidogenic live bacterial product that we postulated could augment CPI response through modulation of the gut microbiome. In this open-label, single-center study (NCT03829111), 30 treatment-naive patients with metastatic renal cell carcinoma with clear cell and/or sarcomatoid histology and intermediate- or poor-risk disease were randomized 2:1 to receive nivolumab and ipilimumab with or without daily oral CBM588, respectively. Stool metagenomic sequencing was performed at multiple timepoints. The primary endpoint to compare the relative abundance of Bifidobacterium spp. at baseline and at 12 weeks was not met, and no significant differences in Bifidobacterium spp. or Shannon index associated with the addition of CBM588 to nivolumab-ipilimumab were detected. Secondary endpoints included response rate, progression-free survival (PFS) and toxicity. PFS was significantly longer in patients receiving nivolumab-ipilimumab with CBM588 than without (12.7 months versus 2.5 months, hazard ratio 0.15, 95% confidence interval 0.05-0.47, P = 0.001). Although not statistically significant, the response rate was also higher in patients receiving CBM588 (58% versus 20%, P = 0.06). No significant difference in toxicity was observed between the study arms. The data suggest that CBM588 appears to enhance the clinical outcome in patients with metastatic renal cell carcinoma treated with nivolumab-ipilimumab. Larger studies are warranted to confirm this clinical observation and elucidate the mechanism of action and the effects on microbiome and immune compartments.",2022,"PFS was significantly longer in patients receiving nivolumab-ipilimumab with CBM588 than without (12.7 months versus 2.5 months, hazard ratio 0.15, 95% confidence interval 0.05-0.47, P = 0.001).","['patients with metastatic renal cell carcinoma treated with nivolumab-ipilimumab', '30 treatment-naive patients with metastatic renal cell carcinoma with clear cell and/or sarcomatoid histology and intermediate- or poor-risk disease', 'patients with cancer', 'metastatic renal cell carcinoma']","['CBM588', 'nivolumab and ipilimumab with or without daily oral CBM588', 'Nivolumab plus ipilimumab with or without live bacterial supplementation']","['response rate, progression-free survival (PFS) and toxicity', 'toxicity', 'relative abundance of Bifidobacterium spp', 'response rate', 'PFS', 'Bifidobacterium spp. or Shannon index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.206726,"PFS was significantly longer in patients receiving nivolumab-ipilimumab with CBM588 than without (12.7 months versus 2.5 months, hazard ratio 0.15, 95% confidence interval 0.05-0.47, P = 0.001).","[{'ForeName': 'Nazli', 'Initials': 'N', 'LastName': 'Dizman', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Meza', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Bergerot', 'Affiliation': 'Cettro Oncologia, Brasilia, Brazil.'}, {'ForeName': 'Marice', 'Initials': 'M', 'LastName': 'Alcantara', 'Affiliation': 'Department of Immunology, Beckman Research Institute, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Dorff', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Yung', 'Initials': 'Y', 'LastName': 'Lyou', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Frankel', 'Affiliation': 'Division of Biostatistics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Division of Biostatistics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Mira', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Llamas', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Joann', 'Initials': 'J', 'LastName': 'Hsu', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Zengin', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Salgia', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Salgia', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Jasnoor', 'Initials': 'J', 'LastName': 'Malhotra', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Chawla', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Chehrazi-Raffle', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Muddasani', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gillece', 'Affiliation': 'The Translational Genomics Research Institute (TGen), Phoenix, AZ, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Reining', 'Affiliation': 'The Translational Genomics Research Institute (TGen), Phoenix, AZ, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Trent', 'Affiliation': 'The Translational Genomics Research Institute (TGen), Phoenix, AZ, USA.'}, {'ForeName': 'Motomichi', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Miyarisan Pharmaceuticals, Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Oka', 'Affiliation': 'Miyarisan Pharmaceuticals, Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Seiya', 'Initials': 'S', 'LastName': 'Higashi', 'Affiliation': 'Miyarisan Pharmaceuticals, Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Kortylewski', 'Affiliation': 'Department of Immunology, Beckman Research Institute, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Highlander', 'Affiliation': 'The Translational Genomics Research Institute (TGen), Phoenix, AZ, USA. sarah@skhighlander.us.'}, {'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA. spal@coh.org.'}]",Nature medicine,['10.1038/s41591-022-01694-6']
2871,35228754,The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial.,"The sodium-glucose cotransporter 2 inhibitor empagliflozin reduces the risk of cardiovascular death or heart failure hospitalization in patients with chronic heart failure, but whether empagliflozin also improves clinical outcomes when initiated in patients who are hospitalized for acute heart failure is unknown. In this double-blind trial (EMPULSE; NCT04157751 ), 530 patients with a primary diagnosis of acute de novo or decompensated chronic heart failure regardless of left ventricular ejection fraction were randomly assigned to receive empagliflozin 10 mg once daily or placebo. Patients were randomized in-hospital when clinically stable (median time from hospital admission to randomization, 3 days) and were treated for up to 90 days. The primary outcome of the trial was clinical benefit, defined as a hierarchical composite of death from any cause, number of heart failure events and time to first heart failure event, or a 5 point or greater difference in change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score at 90 days, as assessed using a win ratio. More patients treated with empagliflozin had clinical benefit compared with placebo (stratified win ratio, 1.36; 95% confidence interval, 1.09-1.68; P = 0.0054), meeting the primary endpoint. Clinical benefit was observed for both acute de novo and decompensated chronic heart failure and was observed regardless of ejection fraction or the presence or absence of diabetes. Empagliflozin was well tolerated; serious adverse events were reported in 32.3% and 43.6% of the empagliflozin- and placebo-treated patients, respectively. These findings indicate that initiation of empagliflozin in patients hospitalized for acute heart failure is well tolerated and results in significant clinical benefit in the 90 days after starting treatment.",2022,Clinical benefit was observed for both acute de novo and decompensated chronic heart failure and was observed regardless of ejection fraction or the presence or absence of diabetes.,"['patients hospitalized for acute heart failure', '530 patients with a primary diagnosis of acute de novo or decompensated chronic heart failure regardless of left ventricular ejection fraction', 'patients with chronic heart failure']","['placebo', 'empagliflozin', 'SGLT2 inhibitor empagliflozin', 'sodium-glucose cotransporter 2 inhibitor empagliflozin', 'empagliflozin 10\u2009mg once daily or placebo', 'Empagliflozin']","['tolerated; serious adverse events', 'hierarchical composite of death from any cause, number of heart failure events and time to first heart failure event, or a 5\u2009point or greater difference in change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score', 'risk of cardiovascular death or heart failure hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",530.0,0.430297,Clinical benefit was observed for both acute de novo and decompensated chronic heart failure and was observed regardless of ejection fraction or the presence or absence of diabetes.,"[{'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands. a.a.voors@umcg.nl.'}, {'ForeName': 'Christiane E', 'Initials': 'CE', 'LastName': 'Angermann', 'Affiliation': 'Comprehensive Heart Failure Centre, University and University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center and Geriatric Research and Education Clinical Care, Tennessee Valley Healthcare Facility VA Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Biegus', 'Affiliation': 'Institute of Heart Diseases, Medical University, Wroclaw, Poland.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'Université de Lorraine, Inserm INI-CRCT (Cardiovascular and Renal Clinical Trialists), Centre Hospitalier Régional Universitaire, Nancy, France.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Nassif', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.""}, {'ForeName': 'Mitchell A', 'Initials': 'MA', 'LastName': 'Psotka', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA, USA.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Tromp', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, and the National University Health System, Singapore, Singapore.'}, {'ForeName': 'C Jan Willem', 'Initials': 'CJW', 'LastName': 'Borleffs', 'Affiliation': 'Haga Teaching Hospital, Den Haag, The Netherlands.'}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Comin-Colet', 'Affiliation': 'Hospital Universitari de Bellvitge (IDIBELL), Barcelona, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fu', 'Affiliation': 'Section of Cardiology, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiovascular Sciences, Clinical Cardiology, Belgium University Hospital, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Kiss', 'Affiliation': 'Department of Cardiology, Military Hospital, Budapest, Hungary.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Schirmer', 'Affiliation': 'Department of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Gentofte University Hospital Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'P Christian', 'Initials': 'PC', 'LastName': 'Schulze', 'Affiliation': 'University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Spinarova', 'Affiliation': 'First Department of Medicine, Masaryk University Hospital, Brno, Czech Republic.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Volterrani', 'Affiliation': 'Department of Cardiology, IRCCS San Raffaele Pisana, Rome, Italy.'}, {'ForeName': 'Jerzy K', 'Initials': 'JK', 'LastName': 'Wranicz', 'Affiliation': 'Department of Electrocardiology, Medical University of Lodz, Central Clinical Hospital, Lodz, Poland.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Zieroth', 'Affiliation': 'Section of Cardiology, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Blatchford', 'Affiliation': 'Elderbrook Solutions GmbH on behalf of Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Salsali', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Institute of Heart Diseases, Medical University, Wroclaw, Poland.'}]",Nature medicine,['10.1038/s41591-021-01659-1']
2872,35231916,Efficacy of Oral Steroids for Acute Acoustic Trauma.,"OBJECTIVE


This study aimed to study the effect of steroid treatment on new-onset sensorineural hearing loss (SNHL) in subjects presenting shortly after an audiometry-confirmed acute acoustic trauma (AAT) injury.
STUDY DESIGN


This is a case-control study.
METHODS


We identified healthy military personnel who presented with AAT injury to the Israeli Defense Forces Medical Corps Otolaryngology/Audiology Services during 2016-2020. Patients were nonrandomly allocated to a treatment arm, where they received steroids (prednisone, 1 mg/kg, 60 mg maximal daily dose), administered for either ≥7 days or <7 days, or to a control arm, in which no treatment was offered besides loud noise avoidance. Audiometries were conducted within 7 days following the AAT and within 1 month later. We compared changes in bone conduction (BC) and air conduction (AC) thresholds at 2-8 kHz.
RESULTS


Of the 263 enrolled subjects, 137 (52%) received steroids and 126 (48%) received no treatment. Subjects who were treated early (<24 h) with high-dose steroids and for ≥7 days demonstrated significantly better hearing outcomes, compared with the nontreatment group. Subjects in the steroids group demonstrated 13-14 dB average improvement in BC thresholds at 3 and 4 kHz (p = 0.001) and additional 7-8 dB average improvement in AC thresholds at 6 and 8 kHz, compared with the nontreatment group (p < 0.0001). These observations were more compelling in patients who initially presented with worse hearing losses (>35 dB). No statistically significant differences were observed in AC/BC pure tone average between the two groups.
CONCLUSIONS


Early oral steroids are recommended in AAT injuries and were shown to improve hearing outcomes within 1 month.",2022,"Subjects in the steroids group demonstrated 13-14 dB average improvement in BC thresholds at 3 and 4 kHz (p = 0.001) and additional 7-8 dB average improvement in AC thresholds at 6 and 8 kHz, compared with the nontreatment group (p < 0.0001).","['Acute Acoustic Trauma', '263 enrolled subjects, 137 (52%) received', 'healthy military personnel who presented with AAT injury to the Israeli Defense Forces Medical Corps Otolaryngology/Audiology Services during 2016-2020', 'patients who initially presented with worse hearing losses (>35 dB', 'subjects presenting shortly after an audiometry-confirmed acute acoustic trauma (AAT) injury']","['Oral Steroids', 'steroids (prednisone', 'steroids', 'steroid treatment']","['hearing outcomes', 'BC thresholds', 'AC/BC pure tone average', 'bone conduction (BC) and air conduction (AC) thresholds']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1148522', 'cui_str': 'Acoustic Trauma'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0029892', 'cui_str': 'Otolaryngology'}, {'cui': 'C0004285', 'cui_str': 'Audiology'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0004286', 'cui_str': 'Audiometric test'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005935', 'cui_str': 'Bone conduction'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0234744', 'cui_str': 'Air conduction'}]",263.0,0.0432567,"Subjects in the steroids group demonstrated 13-14 dB average improvement in BC thresholds at 3 and 4 kHz (p = 0.001) and additional 7-8 dB average improvement in AC thresholds at 6 and 8 kHz, compared with the nontreatment group (p < 0.0001).","[{'ForeName': 'Elchanan', 'Initials': 'E', 'LastName': 'Zloczower', 'Affiliation': 'Medical Corps, Israel Defense Forces, Tel Hashomer, Israel, chanani9@gmail.com.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Tsur', 'Affiliation': 'Medical Corps, Israel Defense Forces, Tel Hashomer, Israel.'}, {'ForeName': 'Shir', 'Initials': 'S', 'LastName': 'Hershkovich', 'Affiliation': 'Medical Corps, Israel Defense Forces, Tel Hashomer, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Fink', 'Affiliation': 'Medical Corps, Israel Defense Forces, Tel Hashomer, Israel.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Marom', 'Affiliation': 'Medical Corps, Israel Defense Forces, Tel Hashomer, Israel.'}]",Audiology & neuro-otology,['10.1159/000522051']
2873,35231887,"Neuroprotective effect of dapsone in patients with aneurysmal subarachnoid hemorrhage: a prospective, randomized, double-blind, placebo-controlled clinical trial.","OBJECTIVE


In this study, the authors sought to define the differences in the incidence of delayed cerebral ischemia (DCI) between patients treated with dapsone and those treated with placebo. Secondary objectives were to define the clinical outcome at discharge and 3 months and the incidence of brain infarction.
METHODS


A prospective, randomized, double-blind, placebo-controlled study was performed and included patients with aneurysmal subarachnoid hemorrhage (SAH) within 5 days from ictus who were candidates for aneurysm occlusion, and who had a Fisher grade of 3 or 4. Patients with sulfa or sulfone drug allergies, hemoglobin < 11 g/dl, known G6PD deficiency, and those refusing informed consent were excluded. A minimal relevant effect decrease of 35% in the incidence of DCI was established. Patients were randomly assigned to receive a regimen of dapsone 2.5 ml (100 mg) daily or a placebo (aluminum hydroxide suspension, 2.5 ml daily). Both groups received validated treatment for aneurysmal SAH. The appearance of DCI on CT was assessed in every patient at discharge and 3 months later. We used the chi-square test to compare the DCI incidence between both groups, and the Student t-test or nonparametric tests to compare quantitative variables.
RESULTS


Overall, 48 patients (70.8% women and 29.2% men) were included. The mean age was 50 years (SD 14.28 years, range 18-72 years). Prerandomization and postrandomization characteristics were balanced, except for the necessity of intra-arterial nimodipine administration in patients treated with placebo (15.4% vs 45.5%, p = 0.029. The incidence of DCI, the primary endpoint, for the whole cohort was 43.8% and was significantly lower in the dapsone group (26.9% vs 63.6%, p = 0.011). In addition, the irreversible DCI incidence was lower in the dapsone group (11.5% vs 54.5%, p = 0.12). A favorable modified Rankin Scale score was more frequent in the dapsone group at discharge and at 3 months (76.9% vs 36.4%, p = 0.005 and 80% vs 38.9%, p = 0.019, respectively). Also, the brain infarction incidence was lower in the dapsone group (19.2% vs 63.6%, p = 0.001). There was no difference between groups regarding adverse events.
CONCLUSIONS


Dapsone seems to play a role as a prophylactic agent in patients at high risk of developing DCI after aneurysmal SAH. A multicenter investigation is necessary to increase the study population and confirm the consistency of the results observed in this study.",2022,"A favorable modified Rankin Scale score was more frequent in the dapsone group at discharge and at 3 months (76.9% vs 36.4%, p = 0.005 and 80% vs 38.9%, p = 0.019, respectively).","['patients with aneurysmal subarachnoid hemorrhage', 'patients with aneurysmal subarachnoid hemorrhage (SAH) within 5 days from ictus who were candidates for aneurysm occlusion, and who had a Fisher grade of 3 or 4', 'patients treated with dapsone and those treated with', 'Patients with sulfa or sulfone drug allergies, hemoglobin < 11 g/dl, known G6PD deficiency, and those refusing informed consent were excluded', '48 patients (70.8% women and 29.2% men) were included', 'The mean age was 50 years (SD 14.28 years, range 18-72 years', 'patients at high risk of developing DCI after aneurysmal SAH']","['Dapsone', 'placebo', 'dapsone', 'dapsone 2.5 ml (100 mg) daily or a placebo (aluminum hydroxide suspension']","['incidence of DCI', 'modified Rankin Scale score', 'brain infarction incidence', 'appearance of DCI on CT', 'delayed cerebral ischemia (DCI', 'irreversible DCI incidence', 'clinical outcome at discharge and 3 months and the incidence of brain infarction', 'DCI incidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0010980', 'cui_str': 'Dapsone'}, {'cui': 'C0038761', 'cui_str': 'Sulfone'}, {'cui': 'C0013182', 'cui_str': 'Allergy to drug'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0237987', 'cui_str': 'Glucose-6-phosphate dehydrogenase deficiency anemia'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}]","[{'cui': 'C0010980', 'cui_str': 'Dapsone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4761225', 'cui_str': 'Delayed cerebral ischaemia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0751955', 'cui_str': 'Brain Infarct'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.225854,"A favorable modified Rankin Scale score was more frequent in the dapsone group at discharge and at 3 months (76.9% vs 36.4%, p = 0.005 and 80% vs 38.9%, p = 0.019, respectively).","[{'ForeName': 'Cuauhtémoc', 'Initials': 'C', 'LastName': 'García-Pastor', 'Affiliation': '1Neurosurgery Department and.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Navarro-Garcia de Llano', 'Affiliation': '1Neurosurgery Department and.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Balcázar-Padrón', 'Affiliation': '1Neurosurgery Department and.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Tristán-López', 'Affiliation': '2Neurochemistry Department, Instituto Nacional de Neurología y Neurocirugía ""Manuel Velasco Suárez,"" Mexico City, Mexico.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Rios', 'Affiliation': '2Neurochemistry Department, Instituto Nacional de Neurología y Neurocirugía ""Manuel Velasco Suárez,"" Mexico City, Mexico.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Díaz-Ruíz', 'Affiliation': '2Neurochemistry Department, Instituto Nacional de Neurología y Neurocirugía ""Manuel Velasco Suárez,"" Mexico City, Mexico.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Rodríguez-Hernandez', 'Affiliation': '1Neurosurgery Department and.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Nathal', 'Affiliation': '1Neurosurgery Department and.'}]",Neurosurgical focus,['10.3171/2021.12.FOCUS21663']
2874,35232310,Recovery and patient satisfaction following radiofrequency ablation and concomitant foam sclerotherapy of varicose veins with and without compression: A randomized controlled non-inferiority trial.,"BACKGROUND


The benefits of postoperative compression are not well established following radiofrequency ablation of the truncal vein and concomitant foam sclerotherapy.
METHODS


A total of 104 patients were randomized: Postoperatively, 54 patients received no compression and 50 patients received class II thigh-high compression. The primary outcome for this study was the difference between means on postoperative pain scores over the first 10 days follow-up measured on a visual analog scale (VAS) from 0 to 100 mm (prespecified delta 10 mm).
RESULTS


The difference between means in no compression and compression group on postoperative pain scores over the 10 days follow-up was 2.1 mm (95% confidence interval -5.1-9.3 mm;  p  = 0.28) indicating non-inferiority. Patients in the no compression group were more satisfied with the visual appearance of the treated leg at 1 month ( p  = 0.003).
CONCLUSION


Over the first 10 postoperative days, no compression was non-inferior to compression on pain scores.",2022,"Patients in the no compression group were more satisfied with the visual appearance of the treated leg at 1 month ( p  = 0.003).
",['104 patients were randomized'],"['class II thigh-high compression', 'radiofrequency ablation and concomitant foam sclerotherapy of varicose veins with and without compression', 'no compression']","['postoperative pain scores', 'visual appearance of the treated leg', 'pain scores', 'visual analog scale (VAS', 'Recovery and patient satisfaction']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0398204', 'cui_str': 'Injection of sclerosing agent in varicose vein'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",104.0,0.335433,"Patients in the no compression group were more satisfied with the visual appearance of the treated leg at 1 month ( p  = 0.003).
","[{'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Pihlaja', 'Affiliation': 'Department of Vascular Surgery, 60664Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Mella', 'Affiliation': 'Department of Vascular Surgery, 60664Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Ohtonen', 'Affiliation': 'Medical Research Center Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Romsi', 'Affiliation': 'Department of Vascular Surgery, 60664Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Pokela', 'Affiliation': 'Department of Vascular Surgery, 60664Oulu University Hospital, Oulu, Finland.'}]",Phlebology,['10.1177/02683555221077742']
2875,35232299,"Recruiting an underserved, difficult to reach population into a cancer trial: Strategies from the  Restore- 2 Rehabilitation Trial for gay and bisexual prostate cancer patients.","BACKGROUND/AIMS


Sexual minorities are small and under-researched populations that are at disproportionate risk for cancer and poor cancer outcomes. Described as a ""hidden population,"" the principal research challenge has been to develop effective methods to identify and recruit such cancer patients into cancer studies. Online recruitment strategies, as well as targeted clinic recruitment using patient-entered sexual orientation and gender identity data from electronic medical records have potential to transform recruitment, but studies testing the effects of how to recruit using these have not been published.
METHODS


In 2019, we conducted a naturalistic, three-arm, stratified prospective study to compare three recruitment strategies: (a) clinic based recruitment of prostate cancer patients from gay health and urology clinics; (b) directly from the gay community; and (c) online recruitment (through cancer support, sex/dating, and social sites). For each strategy, we estimated time, workload, and direct costs involved. To study how recruitment strategy may affect sampling, we tested for retention rates, demographic and outcome differences across sites. Using these methods, we successfully recruited 401 gay and bisexual prostate cancer patients into a randomized, controlled, 24-month trial testing an online sexual and urinary rehabilitation curriculum tailored for this population.
RESULTS


There were seven key results. First, it is possible to recruit substantial numbers of sexual minority men into prostate cancer studies provided online recruitment methods are used. Second, we observed big differences in dropout during study onboarding by recruitment source. Third, within online recruitment, the online sex/dating application (app) was the most successful and efficient, followed by the cancer support site, and then the social networking site. Fourth, while clinics were the cheapest source of recruitment, they were time intensive and low in yield. Fifth, the cancer support site and sex/dating app recruits differed by several characteristics, with the former being more rehabilitation-focused while the latter were younger and more sexually active. Sixth, we found almost no differences in outcomes across the three online recruitment sites. Seventh, because retention in online studies has been a concern, we confirm very low attrition at 3- and 6 months into the trial.
CONCLUSION


For sexual minority cancer research, more research on how to use sexual orientation and gender identity electronic medical record data for clinic-based recruitment is needed. For other small or hard-to-reach populations, researchers should compare and publish online versus offline recruitment strategies.",2022,"Third, within online recruitment, the online sex/dating application (app) was the most successful and efficient, followed by the cancer support site, and then the social networking site.","['prostate cancer patients from gay health and urology clinics; (b) directly from the gay community; and (c) online recruitment (through cancer support, sex/dating, and social sites', 'gay and bisexual prostate cancer patients', '401 gay and bisexual prostate cancer patients']",['online sexual and urinary rehabilitation curriculum tailored for this population'],[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3812395', 'cui_str': 'Urology clinic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],,0.110588,"Third, within online recruitment, the online sex/dating application (app) was the most successful and efficient, followed by the cancer support site, and then the social networking site.","[{'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Simon Rosser', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Hoefer', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Polter', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Kohli', 'Affiliation': 'Department of Educational Psychology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Wheldon', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Haggart', 'Affiliation': 'Department of Urology, Medical School, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Kristine Mc', 'Initials': 'KM', 'LastName': 'Talley', 'Affiliation': 'Adult and Gerontological Health Cooperative, School of Nursing, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Darryl', 'Initials': 'D', 'LastName': 'Mitteldorf', 'Affiliation': 'Malecare Cancer Support, New York, NY, USA.'}, {'ForeName': 'Gunna', 'Initials': 'G', 'LastName': 'Kilian', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Badrinath R', 'Initials': 'BR', 'LastName': 'Konety', 'Affiliation': 'Department of Urology, Rush Medical College, Chicago, IL, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Ross', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'West', 'Affiliation': 'Department of Writing Studies, University of Minnesota, Minneapolis, MN, USA.'}]","Clinical trials (London, England)",['10.1177/17407745221077678']
2876,35228305,Patient-Ventilator Synchrony in Neurally-Adjusted Ventilatory Assist and Variable Pressure Support Ventilation.,"BACKGROUND


Neurally-adjusted ventilatory assist (NAVA) improves patient-ventilator synchrony and reduces the risk of respiratory over-assistance. Variable pressure support ventilation (PSV) is a recently introduced mode of assisted ventilation that has shown reduction in patient-ventilator asynchronies. We hypothesized that NAVA would reduce patient-ventilator asynchronies and inspiratory effort compared to variable PSV because breathing variability was intrinsically determined by the patient and not by the ventilator. This study aimed to evaluate patient-ventilator asynchronies and inspiratory effort pressure-time product (PTP) between NAVA and variable PSV in subjects with mild ARDS.
METHODS


After 24 h of controlled mechanical ventilation, subjects (P aO 2  /F IO 2  200-300 and PEEP level < 10 cm H 2 O) were randomized in sequence 1:1 by using a web-based encrypted platform and assigned to NAVA or variable PSV groups. Both modes of ventilation were consecutively kept for 24 h unless there were clinical changes. The primary aim of this study was to evaluate differences in asynchrony index (AI) between variable PSV and NAVA. Our secondary aims were to evaluate the coefficient of variation (CV) of breathing patterns and inspiratory effort between the groups.
RESULTS


Thirteen subjects were randomized in the NAVA group and 13 subjects in the variable PSV group. AI over time and minute PTP (PTP min ) were not different between NAVA and variable PSV groups (AI t 0   P  = .52, AI t 12   P  = .27, AI t 24   P  = .12; and PTP min-t0   P  = .60, PTP min-t12   P  = .57, PTP min-t24   P  = .85, respectively). CV for tidal volume (V T ) and pressure support (PS) was lower in variable PSV group over time compared with NAVA group ( P  < .05).
CONCLUSIONS


In this randomized controlled trial including subjects with mild ARDS, NAVA and variable PSV had comparable effects on patient-ventilator synchronies and PTP. However, variable PSV reduced the variability of V T  and PS when compared with NAVA.",2022,"CV for tidal volume (V T ) and pressure support (PS) was lower in variable PSV group over time compared with NAVA group ( P  < .05).
","['subjects with mild ARDS', 'Thirteen subjects were randomized in the NAVA group and 13 subjects in the variable PSV group', 'subjects with mild ARDS, NAVA and variable PSV']","['Variable pressure support ventilation (PSV', 'NAVA', 'Neurally-adjusted ventilatory assist (NAVA', 'NAVA and variable PSV']","['coefficient of variation (CV) of breathing patterns and inspiratory effort', 'CV for tidal volume (V T ) and pressure support (PS', 'variability of V T  and PS', 'asynchrony index (AI', 'AI over time and minute PTP (PTP min ']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}]","[{'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0517967', 'cui_str': 'Respiratory pattern'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",13.0,0.0811706,"CV for tidal volume (V T ) and pressure support (PS) was lower in variable PSV group over time compared with NAVA group ( P  < .05).
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vargas', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples ""Federico II,"" via Pansini, Naples, Italy. vargas.maria82@gmail.com.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Buonanno', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples ""Federico II,"" via Pansini, Naples, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sica', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples ""Federico II,"" via Pansini, Naples, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Ball', 'Affiliation': 'San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy; and Department of Surgical Sciences and Integrated Diagnostics, San Martino Policlinico Hospital, IRCCS for Oncology, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Iacovazzo', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples ""Federico II,"" via Pansini, Naples, Italy.'}, {'ForeName': 'Annachiara', 'Initials': 'A', 'LastName': 'Marra', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples ""Federico II,"" via Pansini, Naples, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy; and Department of Surgical Sciences and Integrated Diagnostics, San Martino Policlinico Hospital, IRCCS for Oncology, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Servillo', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples ""Federico II,"" via Pansini, Naples, Italy.'}]",Respiratory care,['10.4187/respcare.08921']
2877,35228753,"The SGLT2 inhibitor canagliflozin in heart failure: the CHIEF-HF remote, patient-centered randomized trial.","Large traditional clinical trials suggest that sodium-glucose co-transporter 2 inhibitors improve symptoms in patients with heart failure and reduced ejection fraction (HFrEF) and in patients with heart failure and preserved ejection fraction (HFpEF). In the midst of the Coronavirus Disease 2019 pandemic, we sought to confirm these benefits in a new type of trial that was patient centered and conducted in a completely remote fashion. In the CHIEF-HF trial ( NCT04252287 ), 476 participants with HF, regardless of EF or diabetes status, were randomized to 100 mg of canagliflozin or placebo. Enrollment was stopped early due to shifting sponsor priorities, without unblinding. The primary outcome was change in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at 12 weeks. The 12-week change in KCCQ TSS was 4.3 points (95% confidence interval, 0.8-7.8; P = 0.016) higher with canagliflozin than with placebo, meeting the primary endpoint. Similar effects were observed in participants with HFpEF and in those with HFrEF and in participants with and without diabetes, demonstrating that canagliflozin significantly improves symptom burden in HF, regardless of EF or diabetes status. This randomized, double-blind trial, conducted without in-person interactions between doctor and patient, can serve as a model for future all-virtual clinical trials.",2022,"Similar effects were observed in participants with HFpEF and in those with HFrEF and in participants with and without diabetes, demonstrating that canagliflozin significantly improves symptom burden in HF, regardless of EF or diabetes status.","['476 participants with HF, regardless of EF or diabetes status', 'patients with heart failure and reduced ejection fraction (HFrEF) and in patients with heart failure and preserved ejection fraction (HFpEF']","['canagliflozin', 'sodium-glucose co-transporter 2 inhibitors', 'canagliflozin or placebo']","['Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS', 'symptom burden in HF, regardless of EF or diabetes status']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",476.0,0.676359,"Similar effects were observed in participants with HFpEF and in those with HFrEF and in participants with and without diabetes, demonstrating that canagliflozin significantly improves symptom burden in HF, regardless of EF or diabetes status.","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City, Kansas City, MO, USA. spertusj@umkc.edu.""}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Birmingham', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nassif', 'Affiliation': ""Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'C V', 'Initials': 'CV', 'LastName': 'Damaraju', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'Wright Center for Clinical and Translation Research and Pauley Heart Center, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Lanfear', 'Affiliation': 'Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School and Baim Institute for Clinical Research, Boston, MA, USA.'}]",Nature medicine,['10.1038/s41591-022-01703-8']
2878,35229065,Denosumab in Cementless Total Hip Arthroplasty: Multivariate Reanalysis of 3D Femoral Stem Migration and the Influence on Outliers.,"In cementless total hip arthroplasty, adequate implant stability is necessary for the success of osseointegration and rapid clinical recovery. Postoperative femoral stem migration, measured by radiostereometric analysis (RSA), defines the initial stability achieved during surgical implantation. In a recent trial of 65 postmenopausal women randomized 1:1 denosumab:placebo, denosumab failed to reduce the initial migration of a cementless femoral stem despite the successful prevention of periprosthetic bone loss. The trial applied the current RSA standard, which examined stem migration on an axis-by-axis basis and did not consider more complex three-dimensional (3D) migration. Therefore, we performed a reanalysis of the trial data using a multivariate hierarchical linear mixed model (LMM). As an additional limitation, the data included influential outliers. Women with normal bone mineral density exhibited significantly ( p  = 0.036) less stem subsidence compared with osteopenic and osteoporotic women. Denosumab significantly decreased the variance of stem migration in osteopenic and osteoporotic women. The mean magnitude of 3D stem migration did not differ between denosumab-treated and placebo-treated women ( p  = 0.820). After application of a common statistical definition for RSA outlier identification, there were eight (12%) outliers, six in the placebo group and two in the denosumab group ( p  = 0.149). After exclusion of the outliers, the repeated LMM analysis demonstrated a trending difference in 3D stem migration ( p  = 0.086), with a significant difference of  z -axis rotation (valgus-varus tilt) of the femoral stem ( p  = 0.029). The observed effect size was small and without clinically important differences in postoperative recovery. Based on a Monte Carlo simulation with random-generated 3D migration data, multivariate LMM showed greater statistical power than univariate analyses. The application of hierarchical LMM facilitated the analysis of implant migration as a factual 3D event. The observed trend in the lower number of RSA outliers in denosumab-treated subjects warrants powered large-scale trials. © 2021 The Authors.  JBMR Plus  published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.",2022,Women with normal bone mineral density exhibited significantly ( p  = 0.036) less stem subsidence compared with osteopenic and osteoporotic women.,"['65 postmenopausal women randomized 1:1', 'Cementless Total Hip Arthroplasty', 'osteopenic and osteoporotic women', '2021']","['placebo', 'Denosumab', 'denosumab:placebo, denosumab']","['mean magnitude of 3D stem migration', 'normal bone mineral density', '3D stem migration', 'periprosthetic bone loss', 'RSA outliers', 'Postoperative femoral stem migration', 'z -axis rotation', 'postoperative recovery', 'variance of stem migration']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C3178874', 'cui_str': 'Roentgen Stereophotogrammetry'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",65.0,0.0978199,Women with normal bone mineral density exhibited significantly ( p  = 0.036) less stem subsidence compared with osteopenic and osteoporotic women.,"[{'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Finnilä', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology Turku University Hospital and University of Turku Turku Finland.'}, {'ForeName': 'Eliisa', 'Initials': 'E', 'LastName': 'Löyttyniemi', 'Affiliation': 'Unit of Biostatistics, Department of Clinical Medicine University of Turku Turku Finland.'}, {'ForeName': 'Hannu T', 'Initials': 'HT', 'LastName': 'Aro', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology Turku University Hospital and University of Turku Turku Finland.'}]",JBMR plus,['10.1002/jbm4.10588']
2879,35229025,A phase 1b/2a multicenter study of the safety and preliminary pharmacodynamic effects of selective muscarinic M 1  receptor agonist HTL0018318 in patients with mild-to-moderate Alzheimer's disease.,"Introduction


This study examined the safety and pharmacodynamic effects of selective muscarinic M 1  receptor orthosteric agonist HTL0018318 in 60 patients with mild-to-moderate Alzheimer's disease (AD) on background donepezil 10 mg/day.
Methods


A randomized, double-blind, placebo-controlled 4-week safety study of HTL0018318 with up-titration and maintenance phases, observing exploratory effects on electrophysiological biomarkers and cognition.
Results


Treatment-emergent adverse events (TEAEs) were mild and less frequently reported during maintenance versus titration. Headache was most commonly reported (7-21%); 0 to 13% reported cholinergic TEAEs (abdominal pain, diarrhea, fatigue, nausea) and two patients discontinued due to TEAEs. At 1 to 2 hours post-dose, HTL0018318-related mean maximum elevations in systolic and diastolic blood pressure of 5 to 10 mmHg above placebo were observed during up-titration but not maintenance. Postive effects of HTL0018318 were found on specific attention and memory endpoints.
Discussion


HTL0018318 was well tolerated in mild-to-moderate AD patients and showed positive effects on attention and episodic memory on top of therapeutic doses of donepezil.",2022,"Postive effects of HTL0018318 were found on specific attention and memory endpoints.
","[""60 patients with mild-to-moderate Alzheimer's disease (AD) on background donepezil 10\xa0mg/day"", ""patients with mild-to-moderate Alzheimer's disease""]","['donepezil', 'selective muscarinic M', 'placebo']","['cholinergic TEAEs (abdominal pain, diarrhea, fatigue, nausea', 'systolic and diastolic blood pressure', 'tolerated', 'specific attention and memory endpoints', 'Headache']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0026815', 'cui_str': 'Muscarinics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242893', 'cui_str': 'Acetylcholine Agents'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",60.0,0.444808,"Postive effects of HTL0018318 were found on specific attention and memory endpoints.
","[{'ForeName': 'Pradeep J', 'Initials': 'PJ', 'LastName': 'Nathan', 'Affiliation': 'Heptares Therapeutics Ltd Cambridge UK.'}, {'ForeName': 'S Babli', 'Initials': 'SB', 'LastName': 'Millais', 'Affiliation': 'Heptares Therapeutics Ltd Cambridge UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Godwood', 'Affiliation': 'Heptares Therapeutics Ltd Cambridge UK.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Dewit', 'Affiliation': 'Heptares Therapeutics Ltd Cambridge UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Cross', 'Affiliation': 'Cross Pharma Consulting Limited Cambridge UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Liptrot', 'Affiliation': 'Heptares Therapeutics Ltd Cambridge UK.'}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Ruparelia', 'Affiliation': 'Heptares Therapeutics Ltd Cambridge UK.'}, {'ForeName': 'Stephen Paul', 'Initials': 'SP', 'LastName': 'Jones', 'Affiliation': 'tranScrip Partners LLP Wokingham UK.'}, {'ForeName': 'Geor', 'Initials': 'G', 'LastName': 'Bakker', 'Affiliation': 'Heptares Therapeutics Ltd Cambridge UK.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Maruff', 'Affiliation': 'Cogstate Ltd New Haven Connecticut USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Light', 'Affiliation': 'Department of Psychiatry University of San Diego San Diego California USA.'}, {'ForeName': 'Alastair J H', 'Initials': 'AJH', 'LastName': 'Brown', 'Affiliation': 'Heptares Therapeutics Ltd Cambridge UK.'}, {'ForeName': 'Malcolm Peter', 'Initials': 'MP', 'LastName': 'Weir', 'Affiliation': 'Heptares Therapeutics Ltd Cambridge UK.'}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Congreve', 'Affiliation': 'Heptares Therapeutics Ltd Cambridge UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Tasker', 'Affiliation': 'Heptares Therapeutics Ltd Cambridge UK.'}]","Alzheimer's & dementia (New York, N. Y.)",['10.1002/trc2.12273']
2880,35229024,Treatment with glucagon-like peptide-1 receptor agonists and incidence of dementia: Data from pooled double-blind randomized controlled trials and nationwide disease and prescription registers.,"Introduction


People with type 2 diabetes have increased risk of dementia. Glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) are among the promising therapies for repurposing as a treatment for Alzheimer's disease; a key unanswered question is whether they reduce dementia incidence in people with type 2 diabetes.
Methods


We assessed exposure to GLP-1 RAs in patients with type 2 diabetes and subsequent diagnosis of dementia in two large data sources with long-term follow-up: pooled data from three randomized double-blind placebo-controlled cardiovascular outcome trials (15,820 patients) and a nationwide Danish registry-based cohort (120,054 patients).
Results


Dementia rate was lower both in patients randomized to GLP-1 RAs versus placebo (hazard ratio [HR]: 0.47 (95% confidence interval [CI]: 0.25-0.86) and in the nationwide cohort (HR: 0.89; 95% CI: 0.86-0.93 with yearly increased exposure to GLP-1 RAs).
Discussion


Treatment with GLP-1 RAs may provide a new opportunity to reduce the incidence of dementia in patients with type 2 diabetes.",2022,Glucagon-like peptide-1,"['controlled cardiovascular outcome trials (15,820 patients) and a nationwide Danish registry-based cohort (120,054 patients', 'people with type 2 diabetes', 'patients with type 2 diabetes and subsequent diagnosis of dementia in two large data sources with long-term follow-up', 'patients with type 2 diabetes']","['Glucagon-like peptide-1', 'placebo', 'GLP-1) receptor agonists (RAs', 'GLP-1 RAs', 'glucagon-like peptide-1 receptor agonists']",['Dementia rate'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0011001', 'cui_str': 'Data Sources'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]",120054.0,0.75452,Glucagon-like peptide-1,"[{'ForeName': 'Caroline Holm', 'Initials': 'CH', 'LastName': 'Nørgaard', 'Affiliation': 'Department of Cardiology and Clinical Research Nordsjællands University Hospital Hillerød Denmark.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Friedrich', 'Affiliation': 'Department of Medical Statistics University Medical Center Göttingen Göttingen Germany.'}, {'ForeName': 'Charlotte Thim', 'Initials': 'CT', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk Søborg Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gerds', 'Affiliation': 'Section of Biostatistics Copenhagen University Østerbro Denmark.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Ballard', 'Affiliation': ""St Luke's Campus University of Exeter College of Medicine and Health Exeter UK.""}, {'ForeName': 'Daniel Vega', 'Initials': 'DV', 'LastName': 'Møller', 'Affiliation': 'Novo Nordisk Søborg Denmark.'}, {'ForeName': 'Lotte Bjerre', 'Initials': 'LB', 'LastName': 'Knudsen', 'Affiliation': 'Novo Nordisk Måløv Denmark.'}, {'ForeName': 'Kajsa', 'Initials': 'K', 'LastName': 'Kvist', 'Affiliation': 'Novo Nordisk Søborg Denmark.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute Mount Sinai Hospital University of Toronto Toronto Ontario Canada.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Holm', 'Affiliation': 'Department of Medicine Nykøbing Falster Hospital Hospitalsvej Nykøbing Falster Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Department of Cardiology and Clinical Research Nordsjællands University Hospital Hillerød Denmark.'}, {'ForeName': 'Lina Steinrud', 'Initials': 'LS', 'LastName': 'Mørch', 'Affiliation': 'Novo Nordisk Søborg Denmark.'}]","Alzheimer's & dementia (New York, N. Y.)",['10.1002/trc2.12268']
2881,35229023,Randomized trial of cognitive training and brain stimulation in non-demented older adults.,"Introduction


Given rapid global population aging, developing interventions against age-associated cognitive decline is an important medical and societal goal. We evaluated a cognitive training protocol combined with transcranial direct current stimulation (tDCS) on trained and non-trained functions in non-demented older adults.
Methods


Fifty-six older adults (65-80 years) were randomly assigned to one of two interventional groups, using age and baseline performance as strata. Both groups performed a nine-session cognitive training over 3 weeks with either concurrent anodal tDCS (atDCS, 1 mA, 20 minutes) over the left dorsolateral prefrontal cortex (target intervention) or sham stimulation (control intervention). Primary outcome was performance on the trained letter updating task immediately after training. Secondary outcomes included performance on other executive and memory (near and far transfer) tasks. All tasks were administered at baseline, post-intervention, and at 1- and 7-month follow-up assessments. Prespecified analyses to investigate treatment effects were conducted using mixed-model analyses.
Results


No between-group differences emerged in the trained letter updating and Markov decision-making tasks at post-intervention and at follow-up timepoints. Secondary analyses revealed group differences in one near-transfer task: Superior n-back task performance was observed in the tDCS group at post-intervention and at follow-up. No such effects were observed for the other transfer tasks. Improvements in working memory were associated with individually induced electric field strengths.
Discussion


Cognitive training with atDCS did not lead to superior improvement in trained task performance compared to cognitive training with sham stimulation. Thus, our results do not support the immediate benefit of tDCS-assisted multi-session cognitive training on the trained function. As the intervention enhanced performance in a near-transfer working memory task, we provide exploratory evidence for effects on non-trained working memory functions in non-demented older adults that persist over a period of 1 month.",2022,"Discussion


Cognitive training with atDCS did not lead to superior improvement in trained task performance compared to cognitive training with sham stimulation.","['Methods\n\n\nFifty-six older adults (65-80 years', 'non-demented older adults']","['cognitive training protocol combined with transcranial direct current stimulation (tDCS', 'concurrent anodal tDCS (atDCS, 1\xa0mA, 20\xa0minutes) over the left dorsolateral prefrontal cortex (target intervention) or sham stimulation (control intervention', 'cognitive training and brain stimulation', 'tDCS']","['performance on other executive and memory (near and far transfer) tasks', 'trained letter updating and Markov decision-making tasks', 'one near-transfer task: Superior n-back task performance', 'performance on the trained letter updating task immediately after training']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0860630', 'cui_str': 'Demented'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",56.0,0.0275736,"Discussion


Cognitive training with atDCS did not lead to superior improvement in trained task performance compared to cognitive training with sham stimulation.","[{'ForeName': 'Daria', 'Initials': 'D', 'LastName': 'Antonenko', 'Affiliation': 'Department of Neurology Universitätsmedizin Greifswald Greifswald Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Thams', 'Affiliation': 'Department of Neurology Universitätsmedizin Greifswald Greifswald Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Grittner', 'Affiliation': 'Berlin Institute of Health (BIH) Berlin Germany.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Uhrich', 'Affiliation': 'Department of Neurology Universitätsmedizin Greifswald Greifswald Germany.'}, {'ForeName': 'Franka', 'Initials': 'F', 'LastName': 'Glöckner', 'Affiliation': 'Lifespan Developmental Neuroscience Faculty of Psychology TU Dresden Dresden Germany.'}, {'ForeName': 'Shu-Chen', 'Initials': 'SC', 'LastName': 'Li', 'Affiliation': 'Lifespan Developmental Neuroscience Faculty of Psychology TU Dresden Dresden Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Flöel', 'Affiliation': 'Department of Neurology Universitätsmedizin Greifswald Greifswald Germany.'}]","Alzheimer's & dementia (New York, N. Y.)",['10.1002/trc2.12262']
2882,35228995,HURWA robotic-assisted total knee arthroplasty improves component positioning and alignment - A prospective randomized and multicenter study.,"Background


The objective of this study was to compare the radiologic and clinical outcomes of HURWA robotic-assisted total knee arthroplasty (TKA) to those of conventional TKA.
Methods


A total of 150 patients were randomized into two groups - 73 and 77 patients underwent robotic-assisted TKA and conventional TKA, respectively. Preoperative and postoperative Western Ontario McMaster University Osteoarthritis Index (WOMAC) score, Hospital for Special Surgery (HSS) score, 36-item Short Form Health Survey (SF-36) score, Knee Society Score (KSS) and range of motion (ROM) were obtained and compared between these two groups. The preoperative and postoperative hip-knee-ankle (HKA) angle and the rate of HKA≤3° in the two groups were also compared.
Results


The postoperative mean HKA angle was 1.801° ​± ​1.608° of varus for the robotic-assisted TKA group and 3.017° ​± ​2.735° of varus for the conventional TKA group; these values were significantly different. The alignment rate for mechanical axis lower than 3° in the robotic-assisted TKA group and the conventional TKA group were 81.2% and 63.5%, respectively. Patients undergone robotic-assisted TKA or conventional TKA had similarly improved knee flexion and functional recovery reflected by WOMAC score, HSS score, SF-36 score and KSS.
Conclusion


HURWA robotic-assisted TKA is a safe and effective, resulting in better alignment for mechanical axis than conventional TKA. The improvement in knee flexion and functional recovery after HURWA robotic-assisted TKA were similar to those after conventional TKA. However, longer follow-up is needed to determine whether the improved alignment of mechanical axis will produce better long-term clinical outcomes.
The translational potential of this article


Recently, the robotic-assisted TKA system has been introduced to clinical practice for TKA. Several robotic-assisted TKA systems, including CASPAR, Tsolution, ROSA, ROBODOC and Mako, have been implemented into clinical application.However, the clinical application of these robotic systems was limited due to their technical complexity, insufficient versatility and increased operative time. Until now, there are still no robotic-assisted TKA systems approved by the National Medical Products Administration of China. Therefore, more robotic-assisted TKA systems need to be designed and improved, particularly in China. Through our randomized, multicenter, single blind and parallel controlled trial, we showed that HURWA robot-assisted TKA system is a safe and effective system for TKA, which had improved knee flexion.",2022,"Patients undergone robotic-assisted TKA or conventional TKA had similarly improved knee flexion and functional recovery reflected by WOMAC score, HSS score, SF-36 score and KSS.
Conclusion


HURWA robotic-assisted TKA is a safe and effective, resulting in better alignment for mechanical axis than conventional TKA.","['group and 3.017°', '150 patients were randomized into two groups - 73 and 77 patients underwent']","['HURWA robotic-assisted total knee arthroplasty (TKA', 'robotic-assisted TKA and conventional TKA', 'HURWA robot-assisted TKA system', 'HURWA robotic-assisted total knee arthroplasty', 'HURWA robotic-assisted TKA', 'robotic-assisted TKA or conventional TKA', 'robotic-assisted TKA']","['alignment rate for mechanical axis', 'knee flexion and functional recovery reflected by WOMAC score, HSS score, SF-36 score', 'Preoperative and postoperative Western Ontario McMaster University Osteoarthritis Index (WOMAC) score, Hospital for Special Surgery (HSS) score, 36-item Short Form Health Survey (SF-36) score, Knee Society Score (KSS) and range of motion (ROM', 'preoperative and postoperative hip-knee-ankle (HKA) angle and the rate of HKA≤3°', 'knee flexion and functional recovery']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",150.0,0.163574,"Patients undergone robotic-assisted TKA or conventional TKA had similarly improved knee flexion and functional recovery reflected by WOMAC score, HSS score, SF-36 score and KSS.
Conclusion


HURWA robotic-assisted TKA is a safe and effective, resulting in better alignment for mechanical axis than conventional TKA.","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaoquan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Joint Surgery, Tianjin Hospital, Tianjin, 300211, PR China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Beijing Chaoyang Hospital, Capital Medical University, 8th Gongren Tiyuchang Nanlu, Chaoyang, Beijing, 100020, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'BEIJING HURWA-ROBOT Medical Technology Co.Ltd, Beijing, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'BEIJING HURWA-ROBOT Medical Technology Co.Ltd, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'BEIJING HURWA-ROBOT Medical Technology Co.Ltd, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopedics, Beijing Chaoyang Hospital, Capital Medical University, 8th Gongren Tiyuchang Nanlu, Chaoyang, Beijing, 100020, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Joint Surgery, Tianjin Hospital, Tianjin, 300211, PR China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Journal of orthopaedic translation,['10.1016/j.jot.2021.12.004']
2883,35228949,Efficacy of Ultrasound-Guided Particulate Versus Nonparticulate Steroid Injection in Carpal Tunnel Syndrome: An Open-Label Randomized Control Trial.,"Introduction Perineural corticosteroid injection is an extensively used and accepted treatment for carpal tunnel syndrome (CTS). However, to this date, there is no guideline as to which corticosteroid has to be used as the standard treatment for CTS. Triamcinolone acetonide is a commonly used particulate steroid that can cause permanent nerve injury if it is accidentally injected into the nerve. Conversely, dexamethasone sodium phosphate is a nonparticulate steroid that would not cause permanent nerve damage following accidental injection. Methods Mild to moderate cases of CTS, confirmed by nerve conduction studies (NCS), with symptoms greater than three months were recruited. The participants received one session of ultrasound-guided perineural injection by the in-plane axial ulnar-sided approach with 4 mL of either dexamethasone (dexamethasone sodium phosphate 8 mg (2 mL) + 2 mL 0.5% bupivacaine) or triamcinolone (triamcinolone acetonide 40 mg/mL (1 mL) + 2 mL 0.5% bupivacaine + 1 mL normal saline) solution. The parameters assessed were Phalen's test time (in seconds), visual analog scale (VAS), and Boston carpal tunnel questionnaire (BCTQ) scores at baseline and two and four months, and NCS changes in sensory nerve conduction velocity (SNCV) and distal motor latency (DML) of the median nerve at baseline and four months. Statistical analysis was conducted using the software SPSS version 26.0 (IBM Corporation, Armonk, NY, USA). Independent samples t-test was used for comparison between groups and the paired t-test for improvement within each group. P values < 0.05 were considered statistically significant. Results The mean age was 42.64 ± 10.99 in the dexamethasone and 45.22 ± 10.602 in the triamcinolone group cases (P = 0.324).There were 58 females (84.06%) and 11 males (15.94%). Each of Phalen's test time, VAS, and BCTQ scores significantly improved within both dexamethasone and triamcinolone groups at the second and fourth months after injection (P < 0.05). The NCS parameters (SNCV and DML) also significantly improved in both groups at the fourth month after the injection (P < 0.05). However, there were no significant differences in the improvement of Phalen's test time between the two groups (P = 0.745), VAS score (P = 0.319), BCTQ score (P = 0.137), SNCV (P = 0.511), or DML (P = 0.753). Postprocedural pain lasted significantly longer in the triamcinolone group (P < 0.05). No major complications were noted in either of the two groups. Conclusion Dexamethasone is as effective as triamcinolone in improving the symptoms of CTS and can be used as a safer and more effective alternative in the treatment of mild to moderate CTS cases.",2022,The NCS parameters (SNCV and DML) also significantly improved in both groups at the fourth month after the injection (P < 0.05).,"['Carpal Tunnel Syndrome', 'group cases (P = 0.324).There were 58 females (84.06%) and 11 males (15.94', 'carpal tunnel syndrome (CTS']","['Dexamethasone', 'ultrasound-guided perineural injection by the in-plane axial ulnar-sided approach with 4 mL of either dexamethasone (dexamethasone sodium phosphate 8 mg (2 mL) + 2 mL 0.5% bupivacaine) or triamcinolone (triamcinolone acetonide 40 mg/mL', 'Triamcinolone acetonide', 'Ultrasound-Guided Particulate Versus Nonparticulate Steroid Injection', 'dexamethasone sodium phosphate', 'bupivacaine + 1 mL normal saline) solution', 'dexamethasone', 'triamcinolone']","['BCTQ score', 'VAS, and BCTQ scores', 'VAS score', 'NCS parameters (SNCV and DML', 'Postprocedural pain', ""improvement of Phalen's test time"", ""Phalen's test time (in seconds), visual analog scale (VAS), and Boston carpal tunnel questionnaire (BCTQ) scores at baseline and two and four months, and NCS changes in sensory nerve conduction velocity (SNCV) and distal motor latency (DML) of the median nerve"", 'major complications']","[{'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0113286', 'cui_str': 'Dexamethasone sodium phosphate'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C2962134', 'cui_str': 'Triamcinolone Acetonide 40 MG/ML'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0457378', 'cui_str': 'Sensory nerve conduction velocity'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025058', 'cui_str': 'Structure of median nerve'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",58.0,0.0772228,The NCS parameters (SNCV and DML) also significantly improved in both groups at the fourth month after the injection (P < 0.05).,"[{'ForeName': 'Merrin M', 'Initials': 'MM', 'LastName': 'Mathew', 'Affiliation': 'Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Jodhpur, IND.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Gaur', 'Affiliation': 'Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Jodhpur, IND.'}, {'ForeName': 'Nitesh', 'Initials': 'N', 'LastName': 'Gonnade', 'Affiliation': 'Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Jodhpur, IND.'}, {'ForeName': 'Satyasheel S', 'Initials': 'SS', 'LastName': 'Asthana', 'Affiliation': 'Physical Medicine and Rehabilitation, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, IND.'}, {'ForeName': 'Rambeer', 'Initials': 'R', 'LastName': 'Ghuleliya', 'Affiliation': 'Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Jodhpur, IND.'}]",Cureus,['10.7759/cureus.21591']
2884,35229327,Comparison of ad libitum snack consumption and acquisition between adolescents living with food security and food insecurity: A stage 1 registered report.,"OBJECTIVE


Approximately 11% of the U.S. population experiences food insecurity (FI; insufficient access to healthy food due to financial constraints). FI is associated with detrimental health outcomes, including the development of eating disorders (EDs). However, additional studies are needed, particularly in adolescence when EDs are likely to emerge. The current study will utilize an experimental ad libitum snack paradigm to investigate snack consumption, acquisition (i.e., taking snacks home), and associated disordered eating behaviors among racially, ethnically, and financially diverse adolescents living with FI and food security (FS).
METHOD


Sixty-four adolescents will be recruited and randomized into one of two conditions: prior knowledge condition (i.e., participants will know prior to snacking that they can take any remaining food home) and no prior knowledge condition (i.e., participants will not know ahead of time that they can take snacks home).
RESULTS


We expect youth with FI to show increased eating and acquisition behaviors compared to youth with FS across both conditions.
DISCUSSION


This study, utilizing a novel experimental design, is an important step in understanding how FI impacts adolescent eating behaviors among youth from marginalized backgrounds, who have historically been excluded from research.",2022,"We expect youth with FI to show increased eating and acquisition behaviors compared to youth with FS across both conditions.
","['disordered eating behaviors among racially, ethnically, and financially diverse adolescents living with FI and food security (FS', 'Sixty-four adolescents', 'adolescents living with food security and food insecurity']",[],['eating and acquisition behaviors'],"[{'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C4517839', 'cui_str': '64'}]",[],"[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",64.0,0.127014,"We expect youth with FI to show increased eating and acquisition behaviors compared to youth with FS across both conditions.
","[{'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Stadterman', 'Affiliation': 'Department of Psychology, Fordham University, Bronx, New York, USA.'}, {'ForeName': 'Yvette G', 'Initials': 'YG', 'LastName': 'Karvay', 'Affiliation': 'Department of Psychology, Fordham University, Bronx, New York, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Feuerstahler', 'Affiliation': 'Department of Psychology, Fordham University, Bronx, New York, USA.'}, {'ForeName': 'Natasha L', 'Initials': 'NL', 'LastName': 'Burke', 'Affiliation': 'Department of Psychology, Fordham University, Bronx, New York, USA.'}]",The International journal of eating disorders,['10.1002/eat.23693']
2885,35229258,Letter to the Editor: A randomised trial to compare the increase in intracranial pressure as correlated with the optic nerve sheath diameter during propofol versus sevoflurane-maintained anesthesia in robot-assisted laparoscopic pelvic surgery.,,2022,,['robot-assisted laparoscopic pelvic surgery'],"['propofol', 'Letter to the Editor', 'sevoflurane-maintained anesthesia']",['intracranial pressure'],"[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}]",,0.0580705,,"[{'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Di Paola', 'Affiliation': ""Department of Medicine Surgery and Dentistry 'Salerno Medical School', University of Salerno, Via S. Allende, Baronissi, 84081, Salerno, Italy.""}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Graziano', 'Affiliation': ""Department of Medicine Surgery and Dentistry 'Salerno Medical School', University of Salerno, Via S. Allende, Baronissi, 84081, Salerno, Italy. mgraziano@unisa.it.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Marotta', 'Affiliation': 'Azienda Ospedaliera Universitaria \'San Giovanni di Dio e Ruggi d\'Aragona\' Plesso \'Ruggi"", Salerno, Italy.'}]",Journal of robotic surgery,['10.1007/s11701-022-01395-9']
2886,35229778,Comparative efficacy of different varieties of toothbrushes in plaque control: A 12-week clinical trial.,"Aim


The aim of this 12 week, single-blind clinical trial was to compare the efficacy of Manual (Oral-B Pro Health Gum care ® ), Powered (Oral-B Cross action Power Dual ® ) and Charcoal (Colgate slim Soft Charcoal ® ) toothbrushes in plaque control.
Materials and Methods


60 systemically healthy students were selected at random among the students of a Dental College, living under similar environment and dietary conditions. Plaque and calculus were removed professionally and three varieties of toothbrush were distributed among them. Plaque index (PI), sulcus bleeding index (SBI) and gingival index (GI) were assessed at baseline, 3, 6 and 12 weeks. Assessment of colony forming units (CFU) was done at baseline and 12 th  week. The learning effect over a period of time was also assessed.
Results


Over the 12-week period, PI reduced significantly (P < 0.001) with % reduction in plaque from 47% to 59%, 41% to 53% and 45% to 55% for manual, powered and charcoal brush. A significant reduction in GI and SBI was also seen with all the brushes. An insignificant difference in PI, GI and SBI was seen between the brushes. CFU count before and after brushing reduced gradually and statistically significantly (P < 0.001) for all the brushes; however, by end of 12 th  week period, there was no significant difference (P > 0.05). The learning effect increased from 35% to 60%, 24% to 56% and 31% to 58% for three brushes, respectively, but was more pronounced for powered brush.
Conclusion


It can be concluded that all the three brushes (manual, powered and charcoal) are clinically effective in removing plaque, with learning effect more pronounced for powered brush and if proper technique is followed, no brush is superior to the other.",2021,"CFU count before and after brushing reduced gradually and statistically significantly (P < 0.001) for all the brushes; however, by end of 12 th  week period, there was no significant difference (P > 0.05).","['60 systemically healthy students were selected at random among the students of a Dental College, living under similar environment and dietary conditions', 'plaque control']","['Manual (Oral-B Pro Health Gum care ® ), Powered (Oral-B Cross action Power Dual ® ) and Charcoal (Colgate slim Soft Charcoal ® ) toothbrushes']","['learning effect', 'PI, GI and SBI', 'GI and SBI', 'CFU count', 'Plaque index (PI), sulcus bleeding index (SBI) and gingival index (GI']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0007955', 'cui_str': 'Charcoal'}, {'cui': 'C2345900', 'cui_str': 'Colgate'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",60.0,0.0317256,"CFU count before and after brushing reduced gradually and statistically significantly (P < 0.001) for all the brushes; however, by end of 12 th  week period, there was no significant difference (P > 0.05).","[{'ForeName': 'Ajit K', 'Initials': 'AK', 'LastName': 'Prusty', 'Affiliation': 'Department of Periodontics, Kalka Dental College, Meerut, Uttar Pradesh, India.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Periodontics, Kalka Dental College, Meerut, Uttar Pradesh, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Malhotra', 'Affiliation': 'Department of Periodontics, ITS Dental College, Ghaziabad, Uttar Pradesh, India.'}]",Indian journal of dental research : official publication of Indian Society for Dental Research,['10.4103/ijdr.IJDR_179_20']
2887,35229777,Resin infiltration and remineralization interventions in management of moderate dental fluorosis: A quantitative light-induced fluorescence-based randomized controlled trial.,"Context


Aesthetic concerns due to dental fluorosis (DF) considerably impact pyschosocial health in young children and requires aesthetic microinvasive treatment.
Aims


The aim of this study was to use quantitative light-induced fluorescence to evaluate two intervention protocols: microabrasion with resin infiltration and microabrasion with remineralization and assess which brings about more fluorescence gain; better colour masking and greater patient satisfaction among subjects with dental fluorosis.
Methods and Material


120 maxillary central incisors with Grade 3 DF (Dean's Fluorosis Index) were randomly distributed into four groups: I-microabrasion + resin infiltration (fluorosis with stains); II microabrasion + remineralization (fluorosis with stains); III-microabrasion + resin infiltration (fluorosis without stains); IV microabrasion + remineralization (fluorosis without stains). At baseline, post-microabrasion and post-intervention Quantitative light-induced fluorescent images were captured. Fluorescence gain (ΔF) was analysed from the blue light images. The white light images were used to evaluate post intervention colour difference (ΔE = [(ΔL*) 2+(Δa*) 2+(Δb*) 2]1/2) and child satisfaction was evaluated.
Statistical Analysis Used


Collected data was analysed using repeated measures ANOVA and Independent t-test.
Results


Intra-group comparison of ΔF values showed statistically significant improvement in ΔF value in all the four groups (P < 0.001, 0.002). Inter-group comparison of ΔF values based on intervention showed statistically significant fluorescence gain (P < 0.004) indicating resin infiltration intervention being better than remineralization in unstained grade III fluorosis. The colour difference was statistically significantly better with resin infiltration in both stained and unstained Grade III DF (P < 0.001).
Conclusions


Resin infiltration intervention showed better fluorescence gain and colour masking compared to remineralization intervention.",2021,Inter-group comparison of ΔF values based on intervention showed statistically significant fluorescence gain (P < 0.004) indicating resin infiltration intervention being better than remineralization in unstained grade III fluorosis.,"['moderate dental fluorosis', 'subjects with dental fluorosis', ""120 maxillary central incisors with Grade 3 DF (Dean's Fluorosis Index"", 'young children']","['microabrasion + resin infiltration (fluorosis with stains); II microabrasion + remineralization (fluorosis with stains); III-microabrasion + resin infiltration (fluorosis without stains); IV microabrasion + remineralization (fluorosis without stains', 'Resin infiltration and remineralization interventions']","['child satisfaction', 'ΔF value', 'fluorescence gain', 'Fluorescence gain (ΔF', 'fluorescence gain and colour masking']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0026618', 'cui_str': 'Dental fluorosis'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0016325', 'cui_str': 'Fluorosis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0016325', 'cui_str': 'Fluorosis'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",120.0,0.020852,Inter-group comparison of ΔF values based on intervention showed statistically significant fluorescence gain (P < 0.004) indicating resin infiltration intervention being better than remineralization in unstained grade III fluorosis.,"[{'ForeName': 'Shreepriya', 'Initials': 'S', 'LastName': 'Singhania', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, JSS Dental College and Hospital, JSS Academy of Higher Education, Mysuru, Karnataka, India.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Nandlal', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, JSS Dental College and Hospital, JSS Academy of Higher Education, Mysuru, Karnataka, India.'}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Shanbhog', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, JSS Dental College and Hospital, JSS Academy of Higher Education, Mysuru, Karnataka, India.'}, {'ForeName': 'Ragavee', 'Initials': 'R', 'LastName': 'Veeramani', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, JSS Dental College and Hospital, JSS Academy of Higher Education, Mysuru, Karnataka, India.'}]",Indian journal of dental research : official publication of Indian Society for Dental Research,['10.4103/ijdr.IJDR_998_20']
2888,35229767,Evaluation of effect of low level laser therapy with intracanal medicament on periapical healing: A randomised control trial.,"Objective(s)


Photobiomodulation, also commonly referred to as low level laser therapy (LLLT), uses light energy to elicit biological responses from the cell and normalise cell function. Using LLLT on bone has been demonstrated to be effective in modulating inflammation, accelerating bone cell proliferation and enhancing the healing process. The objectives of this study were to evaluate postoperative pain and periapical healing in two different groups.
Materials and Methods


40 subjects with periapical lesion were selected and were assigned randomly into two groups. Group I: Conventional root canal therapy along with LLLT. Group II: Conventional root canal therapy only. Radiographs were obtained and assessed at baseline, 3, 6 and 9 months postoperatively. The VAS pain scale was assessed post operatively at 0, 7 th  and 14 th  day respectively. The Independent t-test was used for evaluation of the data.
Results


Significant differences were noted in reduction of periapicallesion at 3 and 9 months follow-up. The healing was better in Group I that received LLLT with the conventional Root Canal Treatment (RCT). Values for postoperative pain was lower in Group I than Group II, but were statistically non-significant.
Conclusion(s)


LLLT when used as an adjunct with conventional root canal treatment showed acceleration of the healing process of periapical lesions. LLLT has a positive effect on modulating the immune response for favourable healing.",2021,"Values for postoperative pain was lower in Group I than Group II, but were statistically non-significant.
Conclusion(s)


LLLT when used as an adjunct with conventional root canal treatment showed acceleration of the healing process of periapical lesions.",['40 subjects with periapical lesion'],"['Conventional root canal therapy', 'LLLT', 'Conventional root canal therapy along with LLLT', 'low level laser therapy with intracanal medicament', 'low level laser therapy (LLLT', 'LLLT with the conventional Root Canal Treatment (RCT']","['VAS pain scale', 'periapical healing', 'postoperative pain and periapical healing', 'reduction of periapicallesion', 'healing process of periapical lesions', 'Values for postoperative pain', 'healing']","[{'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0456386', 'cui_str': 'Medicament'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",40.0,0.0207181,"Values for postoperative pain was lower in Group I than Group II, but were statistically non-significant.
Conclusion(s)


LLLT when used as an adjunct with conventional root canal treatment showed acceleration of the healing process of periapical lesions.","[{'ForeName': 'Deep', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Coorg Institute of Dental Sciences, Virajpet, Karnataka, India.'}, {'ForeName': 'Muckatira Cariappa', 'Initials': 'MC', 'LastName': 'Ponappa', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Coorg Institute of Dental Sciences, Virajpet, Karnataka, India.'}, {'ForeName': 'Kongettira Chittiappa', 'Initials': 'KC', 'LastName': 'Ponnappa', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Coorg Institute of Dental Sciences, Virajpet, Karnataka, India.'}]",Indian journal of dental research : official publication of Indian Society for Dental Research,['10.4103/ijdr.IJDR_896_20']
2889,35229752,Carbohydrate mouth rinsing decreases fatigue index of taekwondo frequency speed of kick test.,"Carbohydrate mouth rinsing (CMR) potentially affects the interval training performance of taekwondo athletes. This study explored the effect of CMR on vertical jump, kicking speed, and fatigue index before and after simulated taekwondo competition. In a crossover experimental design, 13 trained taekwondo athletes were randomly divided into the CMR and control trials. After warming up, the participants used 6.6% maltodextrin (CMR trial) or mineral water (control trial) to rinse their mouth. Next, the participants underwent tests of vertical jump, kicking speed, and maximum number of kicks. After the tests, the participants rinsed their mouth again, followed by using Wingate testing bikes for 5-s sprint and 25-s rest to simulate taekwondo competitions. Four repetitions were performed in each round for 2 min for a total of three rounds. The results revealed that the fatigue index of the participants in the CMR trial before and after the simulated competition was significantly lower than that of the control trial. However, the two trials differed nonsignificantly in their performance in vertical jump, kicking speed, and the simulated competition. Overall, the study results indicated that CMR reduces the fatigue index but no change was observed in performance for vertical jump, kicking speed, and the simulated competition of trained taekwondo athletes.",2022,"Overall, the study results indicated that CMR reduces the fatigue index but no change was observed in performance for vertical jump, kicking speed, and the simulated competition of trained taekwondo athletes.","['13 trained taekwondo athletes', 'taekwondo athletes']","['CMR', 'Carbohydrate mouth rinsing (CMR', 'maltodextrin', 'Carbohydrate mouth rinsing']","['performance for vertical jump, kicking speed', 'performance in vertical jump, kicking speed, and the simulated competition', 'fatigue index of taekwondo frequency speed of kick test', 'vertical jump, kicking speed, and fatigue index', 'fatigue index']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",4.0,0.100359,"Overall, the study results indicated that CMR reduces the fatigue index but no change was observed in performance for vertical jump, kicking speed, and the simulated competition of trained taekwondo athletes.","[{'ForeName': 'Chih-Hui', 'Initials': 'CH', 'LastName': 'Chiu', 'Affiliation': 'Department of Exercise Health Science, National Taiwan University of Sport, Taichung, Taiwan.'}, {'ForeName': 'Che-Hsiu', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Sport Performance, National Taiwan University of Sport, Taichung, Taiwan.'}, {'ForeName': 'Tsung-Jen', 'Initials': 'TJ', 'LastName': 'Yang', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Kuei-Ming', 'Initials': 'KM', 'LastName': 'Chou', 'Affiliation': 'Department of Combat Sport, National Taiwan University of Sport, Taichung, Taiwan.'}, {'ForeName': 'Bo-Wei', 'Initials': 'BW', 'LastName': 'Chen', 'Affiliation': 'Department of Exercise Health Science, National Taiwan University of Sport, Taichung, Taiwan.'}, {'ForeName': 'Zong-Yan', 'Initials': 'ZY', 'LastName': 'Lin', 'Affiliation': 'Department of Exercise Health Science, National Taiwan University of Sport, Taichung, Taiwan.'}, {'ForeName': 'Yung-Chih', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Cheng Ching Hospital, Taichung, Taiwan.'}]",The Chinese journal of physiology,['10.4103/cjp.cjp_99_21']
2890,35229757,"Effect of  Portulaca Oleracea  L. extract on functional constipation: A randomized, double-blind, placebo-controlled trial.","Background


: This study aimed to investigate the efficacy of P. oleracea in the management of patients with functional constipation.
Methods


: A total of 60 patients with functional constipation as defined by the Rome IV criteria were enrolled in this randomized, double-blind, placebo-controlled study; 70% ethanol extracts of the aerial parts of P. oleracea were used for the intervention. Patients were randomly assigned to the P. oleracea or placebo groups. Treatment response, quality of life, and changes in colonic transit time (CTT) were evaluated.
Results


: Complete spontaneous bowel movement (CSBM) improved significantly in the P. oleracea group compared with that in the placebo group over 8 weeks of treatment (P = 0.003). Overall Patient Assessment of Constipation Quality of Life (PAC-QOL) and Patient Assessment of Constipation Symptoms (PAC-SYM) score improvements were observed in the P. oleracea group (P < 0.05). Moreover, CTT decreased from 44.5 ± 22.0 h to 33.7 ± 22.7 h in the P. oleracea group after 7 weeks of treatment (P = 0.04). There were no significant differences in the Bristol Stool Form Scale (BSFS) or adverse events between the groups.
Conclusions


: Compared to placebo, the use of P. oleracea in patients with functional constipation significantly improved CSBM, severity of symptoms, and quality of life. Further large studies are required to assess the benefits of P. oleracea in the treatment of functional constipation.",2022,PAC-SYM) score improvements were observed in the P. oleracea group (P < 0.05).,"['patients with functional constipation', '60 patients with functional constipation as defined by the Rome IV criteria']","['Portulaca Oleracea  L. extract', 'placebo']","['Bristol Stool Form Scale (BSFS) or adverse events', 'PAC-SYM) score improvements', 'CSBM, severity of symptoms, and quality of life', 'Complete spontaneous bowel movement (CSBM', 'Treatment response, quality of life, and changes in colonic transit time (CTT', 'Constipation Quality of Life (PAC-QOL) and Patient Assessment of Constipation Symptoms ', 'functional constipation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0330346', 'cui_str': 'Portulaca oleracea'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}]",60.0,0.437623,PAC-SYM) score improvements were observed in the P. oleracea group (P < 0.05).,"[{'ForeName': 'Ki Bae', 'Initials': 'KB', 'LastName': 'Bang', 'Affiliation': 'Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Jung Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Research Institute R&D Center, Korea Drug Co., Ltd., Seoul, Korea.'}, {'ForeName': 'Jee Hun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Research Institute R&D Center, Korea Drug Co., Ltd., Seoul, Korea.'}, {'ForeName': 'Seong', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Research Institute of Clinical Medicine, Dankook University Hospital, Cheonan, Korea.'}, {'ForeName': 'Mun-Chual', 'Initials': 'MC', 'LastName': 'Rho', 'Affiliation': 'Immunoregulatory Material Research Center, Korea Research Institute of Bioscience and Biotechnology (KRIBB), Jeongeup, Korea.'}, {'ForeName': 'Seung W', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Immunoregulatory Material Research Center, Korea Research Institute of Bioscience and Biotechnology (KRIBB), Jeongeup, Korea.'}, {'ForeName': 'Soyoung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Immunoregulatory Material Research Center, Korea Research Institute of Bioscience and Biotechnology (KRIBB), Jeongeup, Korea.'}, {'ForeName': 'Jeong Eun', 'Initials': 'JE', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea.'}]",Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association,['10.4103/sjg.sjg_400_21']
2891,35229713,Arthroscopic hip surgery compared with personalised hip therapy in people over 16 years old with femoroacetabular impingement syndrome: UK FASHIoN RCT.,"BACKGROUND


Femoroacetabular impingement syndrome is an important cause of hip pain in young adults. It can be treated by arthroscopic hip surgery or with physiotherapist-led conservative care.
OBJECTIVE


To compare the clinical effectiveness and cost-effectiveness of hip arthroscopy with best conservative care.
DESIGN


The UK FASHIoN (full trial of arthroscopic surgery for hip impingement compared with non-operative care) trial was a pragmatic, multicentre, randomised controlled trial that was carried out at 23 NHS hospitals.
PARTICIPANTS


Participants were included if they had femoroacetabular impingement, were aged ≥ 16 years old, had hip pain with radiographic features of cam or pincer morphology (but no osteoarthritis) and were believed to be likely to benefit from hip arthroscopy.
INTERVENTION


Participants were randomly allocated (1 : 1) to receive hip arthroscopy followed by postoperative physiotherapy, or personalised hip therapy (i.e. an individualised physiotherapist-led programme of conservative care). Randomisation was stratified by impingement type and recruiting centre using a central telephone randomisation service. Outcome assessment and analysis were masked.
MAIN OUTCOME MEASURE


The primary outcome was hip-related quality of life, measured by the patient-reported International Hip Outcome Tool (iHOT-33) 12 months after randomisation, and analysed by intention to treat.
RESULTS


Between July 2012 and July 2016, 648 eligible patients were identified and 348 participants were recruited. In total, 171 participants were allocated to receive hip arthroscopy and 177 participants were allocated to receive personalised hip therapy. Three further patients were excluded from the trial after randomisation because they did not meet the eligibility criteria. Follow-up at the primary outcome assessment was 92% ( N  = 319; hip arthroscopy,  n  = 157; personalised hip therapy,  n  = 162). At 12 months, mean International Hip Outcome Tool (iHOT-33) score had improved from 39.2 (standard deviation 20.9) points to 58.8 (standard deviation 27.2) points for participants in the hip arthroscopy group, and from 35.6 (standard deviation 18.2) points to 49.7 (standard deviation 25.5) points for participants in personalised hip therapy group. In the primary analysis, the mean difference in International Hip Outcome Tool scores, adjusted for impingement type, sex, baseline International Hip Outcome Tool score and centre, was 6.8 (95% confidence interval 1.7 to 12.0) points in favour of hip arthroscopy ( p  = 0.0093). This estimate of treatment effect exceeded the minimum clinically important difference (6.1 points). Five (83%) of six serious adverse events in the hip arthroscopy group were related to treatment and one serious adverse event in the personalised hip therapy group was not. Thirty-eight (24%) personalised hip therapy patients chose to have hip arthroscopy between 1 and 3 years after randomisation. Nineteen (12%) hip arthroscopy patients had a revision arthroscopy. Eleven (7%) personalised hip therapy patients and three (2%) hip arthroscopy patients had a hip replacement within 3 years.
LIMITATIONS


Study participants and treating clinicians were not blinded to the intervention arm. Delays were encountered in participants accessing treatment, particularly surgery. Follow-up lasted for 3 years.
CONCLUSION


Hip arthroscopy and personalised hip therapy both improved hip-related quality of life for patients with femoroacetabular impingement syndrome. Hip arthroscopy led to a greater improvement in quality of life than personalised hip therapy, and this difference was clinically significant at 12 months. This study does not demonstrate cost-effectiveness of hip arthroscopy compared with personalised hip therapy within the first 12 months. Further follow-up will reveal whether or not the clinical benefits of hip arthroscopy are maintained and whether or not it is cost-effective in the long term.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN64081839.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 26, No. 16. See the NIHR Journals Library website for further project information.",2022,"Hip arthroscopy led to a greater improvement in quality of life than personalised hip therapy, and this difference was clinically significant at 12 months.","['Between July 2012 and July 2016, 648 eligible patients were identified and 348 participants were recruited', 'people over 16 years old with femoroacetabular impingement syndrome', 'Participants were included if they had femoroacetabular impingement, were aged ≥\u200916 years old, had hip pain with radiographic features of cam or pincer morphology (but no osteoarthritis) and were believed to be likely to benefit from hip arthroscopy', 'patients with femoroacetabular impingement syndrome', '171 participants were allocated to receive hip arthroscopy and 177 participants', '23 NHS hospitals', 'young adults']","['personalised hip therapy', 'Hip arthroscopy and personalised hip therapy', 'arthroscopic surgery', 'Arthroscopic hip surgery', 'hip arthroscopy', 'Hip arthroscopy', 'arthroscopic hip surgery or with physiotherapist-led conservative care', 'hip arthroscopy followed by postoperative physiotherapy, or personalised hip therapy (i.e. an individualised physiotherapist-led programme of conservative care', 'FASHIoN', 'hip arthroscopy with best conservative care']","['revision arthroscopy', 'hip-related quality of life', 'clinical effectiveness and cost-effectiveness', 'hip-related quality of life, measured by the patient-reported International Hip Outcome Tool (iHOT-33', 'International Hip Outcome Tool scores, adjusted for impingement type, sex, baseline International Hip Outcome Tool score and centre', 'quality of life', 'mean International Hip Outcome Tool (iHOT-33) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2936290', 'cui_str': 'Femoral acetabular impingement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0186190', 'cui_str': 'Diagnostic arthroscopy of hip joint'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0186190', 'cui_str': 'Diagnostic arthroscopy of hip joint'}, {'cui': 'C0750934', 'cui_str': 'Arthroscopy with surgical procedure'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",171.0,0.0835399,"Hip arthroscopy led to a greater improvement in quality of life than personalised hip therapy, and this difference was clinically significant at 12 months.","[{'ForeName': 'Damian R', 'Initials': 'DR', 'LastName': 'Griffin', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Dickenson', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Achana', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Griffin', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Peter Dh', 'Initials': 'PD', 'LastName': 'Wall', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Realpe', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hobson', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Fry', 'Affiliation': 'Lay person, Reading, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Jepson', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Petrou', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Hutchinson', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Foster', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences NIHR, Keele University, Keele, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Donovan', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/FXII0508']
2892,35229714,Deep-sequence phylogenetics to quantify patterns of HIV transmission in the context of a universal testing and treatment trial - BCPP/ Ya Tsie trial.,"Background:  Mathematical models predict that community-wide access to HIV testing-and-treatment can rapidly and substantially reduce new HIV infections. Yet several large universal test-and-treat HIV prevention trials in high-prevalence epidemics demonstrated variable reduction in population-level incidence.
Methods:  To elucidate patterns of HIV spread in universal test-and-treat trials we quantified the contribution of geographic-location, gender, age and randomized-HIV-intervention to HIV transmissions in the 30-community Ya Tsie trial in Botswana. We sequenced HIV viral whole genomes from 5,114 trial participants among the 30 trial communities.
Results:  Deep-sequence phylogenetic analysis revealed that most inferred HIV transmissions within the trial occurred within the same or between neighboring communities, and between similarly-aged partners. Transmissions into intervention communities from control communities were more common than the reverse post-baseline (30% [12.2 - 56.7] versus 3% [0.1 - 27.3]) than at baseline (7% [1.5 - 25.3] versus 5% [0.9 - 22.9]) compatible with a benefit from treatment-as-prevention.
Conclusion:  Our findings suggest that population mobility patterns are fundamental to HIV transmission dynamics and to the impact of HIV control strategies.
Funding:  This study was supported by the National Institute of General Medical Sciences (U54GM088558); the Fogarty International Center (FIC) of the U.S. National Institutes of Health (D43 TW009610); and the President's Emergency Plan for AIDS Relief through the Centers for Disease Control and Prevention (CDC) (Cooperative agreements U01 GH000447 and U2G GH001911).",2022,"Transmissions into intervention communities from control communities were more common than the reverse post-baseline (30% [12.2 - 56.7] versus 3% [0.1 - 27.3]) than at baseline (7% [1.5 - 25.3] versus 5% [0.9 - 22.9]) compatible with a benefit from treatment-as-prevention.
","['5,114 trial participants among the 30 trial communities']",[],[],"[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],[],,0.630093,"Transmissions into intervention communities from control communities were more common than the reverse post-baseline (30% [12.2 - 56.7] versus 3% [0.1 - 27.3]) than at baseline (7% [1.5 - 25.3] versus 5% [0.9 - 22.9]) compatible with a benefit from treatment-as-prevention.
","[{'ForeName': 'Lerato E', 'Initials': 'LE', 'LastName': 'Magosi', 'Affiliation': 'Department of Epidemiology, Harvard University, Boston, United States.'}, {'ForeName': 'Yinfeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Division of Molecular and Genomic Pathology, University of Pittsburgh Medical Center, Pittsburgh, United States.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Golubchik', 'Affiliation': 'Big Data Institute, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'DeGruttola', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tchetgen Tchetgen', 'Affiliation': 'Department of Statistics, University of Pennsylvania, Philadelphia, United States.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Novitsky', 'Affiliation': 'Department of Immunology and Infectious Disease, Harvard T H Chan School of Public Health, Boston, United States.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Division of Global HIV/AIDS and TB, Centers for Disease Control and Prevention, Atlanta, United States.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Bachanas', 'Affiliation': 'Division of Global HIV/AIDS and TB, Centers for Disease Control and Prevention, Atlanta, United States.'}, {'ForeName': 'Tebogo', 'Initials': 'T', 'LastName': 'Segolodi', 'Affiliation': 'HIV Prevention Research Unit, Centers for Disease Control and Prevention, Gaborone, Botswana.'}, {'ForeName': 'Refeletswe', 'Initials': 'R', 'LastName': 'Lebelonyane', 'Affiliation': 'Ministry of Health, Gaborone, Botswana.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Pretorius Holme', 'Affiliation': 'epartment of Immunology and Infectious Disease, Harvard T H Chan School of Public Health, Boston, United States.'}, {'ForeName': 'Sikhulile', 'Initials': 'S', 'LastName': 'Moyo', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Makhema', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Lockman', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital, Boston, United States.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Fraser', 'Affiliation': 'Big Data Institute, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Myron Max', 'Initials': 'MM', 'LastName': 'Essex', 'Affiliation': 'Department of Immunology and Infectious Disease, Harvard T H Chan School of Public Health, Boston, United States.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lipsitch', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard TH Chan School of Public Health, Boston, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",eLife,['10.7554/eLife.72657']
2893,35229697,Effect of electromyographic biofeedback training on functional status in zone I-III flexor tendon injuries: a randomized controlled trial.,"BACKGROUND


Despite advances in hand therapy and surgery, functional deficits persist after flexor tendon repair especially in zone I-III. This suggests that methods applied may be insufficient. Electromyographic (EMG) biofeedback may provide an effective tendon gliding through visual and auditory feedback.
PURPOSE


The purpose of this study was to investigate the effect of EMG biofeedback training applied in addition to early passive motion protocol on functional status in zone I-III flexor tendon injuries.
METHODS


Patients were randomly assigned into two groups, each consisted of 11 patients. In addition to early passive motion method, EMG biofeedback training was applied in the first group. The second group was followed only with early passive motion protocol. Joint range of motion (ROM), Michigan Hand Outcomes Questionnaire (MHQ) and grip strength were evaluated.
RESULTS


There were no significant differences between the groups in terms of the ROM, MHQ scores and grip strength (p ≥ .087). However, there were clinically important differences in the results of the 12th week ROM (effect size = 0.70), 24th week activity of daily living (ADL) score in MHQ (effect size = 0.68), 12th week gross, tip pinch and lateral grip strength (effect sizes = 0.59, 0.52, 0.81, respectively) and 24th week gross, tip pinch and lateral grip strength (effect sizes = 0.69, 0.73, 0.69, respectively) between the two groups.
CONCLUSIONS


EMG biofeedback training was clinically but not statistically superior to early passive motion method in terms of the effect on functional status.",2022,"There were no significant differences between the groups in terms of the ROM, MHQ scores and grip strength (p ≥ .087).","['zone I-III flexor tendon injuries', 'Patients were randomly assigned into two groups, each consisted of 11 patients']","['Electromyographic (EMG) biofeedback', 'electromyographic biofeedback training', 'EMG biofeedback training']","['tip pinch and lateral grip strength', 'functional status', 'Joint range of motion (ROM), Michigan Hand Outcomes Questionnaire (MHQ) and grip strength', 'ROM, MHQ scores and grip strength', '24th week activity of daily living (ADL) score in MHQ']","[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0224848', 'cui_str': 'Structure of flexor tendon'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0204624', 'cui_str': 'Electromyographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0429273', 'cui_str': 'Tip pinch'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",11.0,0.0323077,"There were no significant differences between the groups in terms of the ROM, MHQ scores and grip strength (p ≥ .087).","[{'ForeName': 'Umut', 'Initials': 'U', 'LastName': 'Eraslan', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Kitis', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Ahmet Fahir', 'Initials': 'AF', 'LastName': 'Demirkan', 'Affiliation': 'Department of Orthopaedics and Traumatology, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Ramazan Hakan', 'Initials': 'RH', 'LastName': 'Ozcan', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}]",Physiotherapy theory and practice,['10.1080/09593985.2022.2043499']
2894,35232647,Probiotics for gallstones prevention in bariatric surgery patients: A prospective randomized trial.,"BACKGROUND


Gall stone disease was known to increase after bariatric surgery. Ursodeoxycholic acid (UDCA) might reduce the gallstone formation rate after bariatric surgery. However, other option for gallstone prevention was unclear. We reported the result of a randomized trial comparing the gallstone prevention efficacy of probiotics and digestive enzyme versus UDCA.
METHODS


This prospective, randomized trial was held in an institute of Taiwan. Patients were eligible for inclusion if their body-mass index (BMI) was 32.5 kg/m2 or higher with the presence of comorbidity, or 27.5 kg/mw or higher with not-well controlled type 2 diabetes, and were aged 18-65 years. Participant were randomized assigned (1:1:1) to probiotic, digestive enzyme or UDCA. The primary endpoint was assessed in the incidence of gallstone disease at 6 months after surgery. This study is registered with ClinicalTrials.gov. number NCT03247101, and is now completed.
RESULTS


From January 2016 to December 2018, of 186 patients screened for eligibility, 152 were randomly assigned to probiotic (52) or digestive enzyme (52) or UDCA (52). In the per-protocol population, mean age was 35.9 years (SD 10.6), mean BMI was 40.3 kg/m 2  (SD 6.9), 57(58.2%) were female. After 6 months, the incidence of gall bladder diseased was 15.2%, in the probiotics group, 17.6% in UDCA group and 29.1% in digestive enzyme groups, confirming non-inferiority of probiotic (p = 0.38). Female gender was identified as a risk factor for gall bladder disease after bariatric surgery (odds ratio = 4.61, 95% confidence interval = 1.05, 20.3, p = 0.04). The poor drug compliance rate was 19.5%, 22.7% and 26.2% in probiotics, UDCA and digestive enzyme group respectively. UDCA group had a higher drug adverse effect than probiotic group (15.9% vs. 2.4%, p = 0.03).
CONCLUSION


Probiotic is not inferior to UDCA regarding gall bladder disease prevention after bariatric surgery at 6 months.",2022,"UDCA group had a higher drug adverse effect than probiotic group (15.9% vs. 2.4%, p = 0.03).
","['bariatric surgery patients', 'From January 2016 to December 2018, of 186 patients screened for eligibility, 152 were randomly assigned to', 'mw or higher with not-well controlled type 2 diabetes, and were aged 18-65 years', 'Patients were eligible for inclusion if their body-mass index (BMI) was 32.5\xa0kg/m2 or higher with the presence of comorbidity, or 27.5\xa0kg', 'In the per-protocol population, mean age was 35.9 years (SD 10.6), mean BMI was 40.3\xa0kg']","['probiotics and digestive enzyme versus UDCA', 'UDCA', 'Ursodeoxycholic acid (UDCA', 'probiotic (52) or digestive enzyme (52) or UDCA', 'probiotic, digestive enzyme or UDCA', 'Probiotics']","['incidence of gall bladder diseased', 'incidence of gallstone disease', 'gallstone formation rate', 'drug adverse effect', 'poor drug compliance rate']","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0544420', 'cui_str': 'Digestive enzyme'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.235721,"UDCA group had a higher drug adverse effect than probiotic group (15.9% vs. 2.4%, p = 0.03).
","[{'ForeName': 'Ming-Lun', 'Initials': 'ML', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Integrated Diagnostics & Therapeutics, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ming-Hsien', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Metabolic & Bariatric Surgical Department, Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taiwan.'}, {'ForeName': 'Wei-Jei', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Min-Sheng General Hospital, Taoyuan, Taiwan. Electronic address: wjlee_obessurg_tw@yahoo.com.tw.'}, {'ForeName': 'Shu-Chun', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Department of Surgery, Min-Sheng General Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Owaid M', 'Initials': 'OM', 'LastName': 'Almalki', 'Affiliation': 'Department of Surgery, College of Medicine, Taif University, Saudi Arabia.'}, {'ForeName': 'Jung-Chien', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Surgery, Min-Sheng General Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Chun-Chi', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'Department of Surgery, Min-Sheng General Hospital, Taoyuan, Taiwan.'}]",Asian journal of surgery,['10.1016/j.asjsur.2022.01.120']
2895,35232603,"Re: Oscar Reig Torras, Akhilesh Mishra, Alana Christie, et al. Molecular Genetic Determinants of Shorter Time on Active Surveillance in a Prospective Phase 2 Clinical Trial in Metastatic Renal Cell Carcinoma. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2021.12.003.",,2022,,['Metastatic Renal Cell Carcinoma'],[],[],"[{'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}]",[],[],,0.0634062,,"[{'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China. Electronic address: beijingzhangyushi@126.com.'}]",European urology,['10.1016/j.eururo.2022.01.047']
2896,35232602,"Re: Veerle H. Groen, Karin Haustermans, Floris J. Pos, et al. Patterns of Failure Following External Beam Radiotherapy With or Without an Additional Focal Boost in the Randomized Controlled FLAME Trial for Localized Prostate Cancer. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2021.12.012.",,2022,,[],['External Beam Radiotherapy'],[],[],"[{'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}]",[],,0.161526,,"[{'ForeName': 'Kamal Kant', 'Initials': 'KK', 'LastName': 'Sahu', 'Affiliation': 'Department of Hematology and Medical Oncology, Huntsman Cancer Institute, University of Utah Health, Salt Lake City, UT, USA. Electronic address: kamal.sahu@hci.utah.edu.'}]",European urology,['10.1016/j.eururo.2022.02.018']
2897,35229554,Relationship between plasma Neuregulin-1 and cardiac function in patients with ST-elevation myocardial infarction.,"BACKGROUND


Neuregulin-1 (NRG-1) is a stress-mediated transmembrane growth factor. Reduced myocardial damage and higher NRG-1 levels upon treatment with remote ischemic conditioning (RIC) has been described in rats. However, the role of NRG-1 in patients with acute myocardial infarction (MI) is unknown. Thus, we conducted a post hoc analysis of a randomized controlled trial that tested RIC in patients with MI scheduled for primary percutaneous coronary intervention (PCI).
METHODS


Blood was drawn from 30 patients before RIC/PCI, within 1 hour, 4 days and 1 month later. Median left ventricular ejection fraction (LVEF) in the overall study population following MI was 48.5%.
RESULTS


NRG-1 plasma levels decreased significantly following PCI/RIC and remained decreased up to 1 month following MI ( p  < 0.0001). We observed no association of NRG-1 with other variables, including total ischemic time, LVEF or RIC.
CONCLUSIONS


Thus, we identified NRG-1 may be independently affected by MI. However, further large clinical trials are warranted to clarify this hypothesis.",2022,"RESULTS


NRG-1 plasma levels decreased significantly following PCI/RIC and remained decreased up to 1 month following MI ( p  < 0.0001).","['patients with acute myocardial infarction (MI', 'patients with ST-elevation myocardial infarction', 'patients with MI scheduled for primary percutaneous coronary intervention (PCI', '30 patients before RIC/PCI, within 1 hour, 4 days and 1 month later']",['NRG-1'],"['Median left ventricular ejection fraction (LVEF', 'myocardial damage and higher NRG-1 levels', 'total ischemic time, LVEF or RIC', 'NRG-1 plasma levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0626201', 'cui_str': 'NDF Protein'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0626201', 'cui_str': 'NDF Protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.142139,"RESULTS


NRG-1 plasma levels decreased significantly following PCI/RIC and remained decreased up to 1 month following MI ( p  < 0.0001).","[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Haller', 'Affiliation': 'Department of Cardiology, University Heart & Vascular Center Hamburg, 20249 Hamburg, Germany.'}, {'ForeName': 'Inês F', 'Initials': 'IF', 'LastName': 'Gonçalves', 'Affiliation': 'Center for Biomedical Research, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Eylem', 'Initials': 'E', 'LastName': 'Acar', 'Affiliation': 'Center for Biomedical Research, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Jäger', 'Affiliation': 'Faculty of Medicine, Sigmund Freud Private University, 1020 Vienna, Austria.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Pilz', 'Affiliation': 'Center for Biomedical Research, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Wojta', 'Affiliation': 'Core Facilities, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Ludwig Boltzmann Institute for Cardiovascular Research, 1090 Vienna, Austria.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Center for Biomedical Research, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Bruno K', 'Initials': 'BK', 'LastName': 'Podesser', 'Affiliation': 'Center for Biomedical Research, Medical University of Vienna, 1090 Vienna, Austria.'}]",Reviews in cardiovascular medicine,['10.31083/j.rcm2302063']
2898,35229548,"A prospective, randomized, double-blind, placebo-controlled trial of polyphenols on the outcomes of inflammatory factors and oxidative stress in patients with type 2 diabetes mellitus.","BACKGROUND


Type 2 diabetes mellitus (T2DM) is commonly associated with hyperglycemia, dyslipidemia, oxidative stress and inflammation which are well known cardiovascular risk factors. Pomegranate peel polyphenols have a proven hypolipemic, antioxidant and anti-inflammatory activity. However, there is a lack of clinical studies that would confirm its antioxidant and anti-inflammatory effects in diabetic patients. The potential of pomegranate peel extract (PoPEx) to counteract inflammation and oxidative stress in T2DM patients was investigated. For this purpose, a randomized, double-blind placebo-controlled study involving adult T2DM patients treated with PoPEx or placebo for eight-weeks was conducted.
METHODS


Patients were randomly divided into two groups: the first group (n = 30) received capsules containing PoPEx 250 mg twice daily, while the placebo group (n = 30) received placebo capsules twice daily. Plasma concentration of inflammatory factors (interleukin 6 (IL-6), tumor necrosis factor α (TNF-α) and high sensitivity C reactive protein (hsCRP)), oxidative stress biomarkers (thiobarbituric acid reactive substances (TBARS), nitrites (NO2-), superoxide anion radical (O2-), hydrogen peroxide (H2O2), total antioxidant capacity (TAC)), homocysteine and lipid profile were analyzed.
RESULTS


The PoPEx treatment showed a significant reduction of inflammatory factors (IL-6, TNF-α, hsCRP), oxidative stress biomarkers (TBARS, NO2-, O2-) and homocysteine, while the TAC was increased. Moreover, a significant improvement in lipid profile was observed in the PoPEx group. Additional analysis showed a significant inverse correlation between the decrements of all measured inflammatory markers and TAC in the PoPEx group.
CONCLUSIONS


The study demonstrated that eight-week-long PoPEx administration had favorable effects on inflammatory status and oxidative stress biomarkers in diabetic patients.",2022,"The PoPEx treatment showed a significant reduction of inflammatory factors (IL-6, TNF-α, hsCRP), oxidative stress biomarkers (TBARS, NO2-, O2-) and homocysteine, while the TAC was increased.","['Patients', 'diabetic patients', 'patients with type 2 diabetes mellitus', 'adult T2DM patients treated with', 'T2DM patients']","['capsules containing PoPEx 250 mg twice daily, while the placebo', 'placebo', 'PoPEx or placebo', 'PoPEx', 'pomegranate peel extract (PoPEx', 'polyphenols', 'placebo capsules twice daily']","['inflammatory factors and oxidative stress', 'inflammatory markers and TAC', 'Plasma concentration of inflammatory factors (interleukin 6 (IL-6), tumor necrosis factor α (TNF-α) and high sensitivity C reactive protein (hsCRP)), oxidative stress biomarkers (thiobarbituric acid reactive substances (TBARS), nitrites (NO2-), superoxide anion radical (O2-), hydrogen peroxide (H2O2), total antioxidant capacity (TAC)), homocysteine and lipid profile', 'inflammatory status and oxidative stress biomarkers', 'inflammatory factors (IL-6, TNF-α, hsCRP), oxidative stress biomarkers (TBARS, NO2-, O2-) and homocysteine, while the TAC', 'lipid profile']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0132254', 'cui_str': 'drebrin A'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1509685', 'cui_str': 'POMEGRANATE FRUIT EXTRACT'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0038836', 'cui_str': 'Superoxide'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.393055,"The PoPEx treatment showed a significant reduction of inflammatory factors (IL-6, TNF-α, hsCRP), oxidative stress biomarkers (TBARS, NO2-, O2-) and homocysteine, while the TAC was increased.","[{'ForeName': 'Milkica', 'Initials': 'M', 'LastName': 'Grabež', 'Affiliation': 'Department of Hygiene, Faculty of Medicine University of Banja Luka, 78000 Banja Luka, the Republic of Srpska, Bosnia & Herzegovina.'}, {'ForeName': 'Ranko', 'Initials': 'R', 'LastName': 'Škrbić', 'Affiliation': 'Department of Pharmacology, Toxicology and Clinical Pharmacology, Faculty of Medicine University of Banja Luka, 78000 Banja Luka, the Republic of Srpska, Bosnia & Herzegovina.'}, {'ForeName': 'Miloš P', 'Initials': 'MP', 'LastName': 'Stojiljković', 'Affiliation': 'Department of Pharmacology, Toxicology and Clinical Pharmacology, Faculty of Medicine University of Banja Luka, 78000 Banja Luka, the Republic of Srpska, Bosnia & Herzegovina.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Vučić', 'Affiliation': 'Centre of Research Excellence in Nutrition and Metabolism, Institute for Medical Research University of Belgrade, 11000 Beograd, Serbia.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Rudić Grujić', 'Affiliation': 'Department of Hygiene, Faculty of Medicine University of Banja Luka, 78000 Banja Luka, the Republic of Srpska, Bosnia & Herzegovina.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Jakovljević', 'Affiliation': 'Department of Physiology, Faculty of Medical Sciences University of Kragujevac, 34000 Kragujevac, Serbia.'}, {'ForeName': 'Dragan M', 'Initials': 'DM', 'LastName': 'Djuric', 'Affiliation': 'Institute of Medical Physiology ""Richard Burian"", Faculty of Medicine University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Relja', 'Initials': 'R', 'LastName': 'Suručić', 'Affiliation': 'Department of Pharmacоgnosy, Faculty of Medicine University of Banja Luka, 78000 Banja Luka, the Republic of Srpska, Bosnia & Herzegovina.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Šavikin', 'Affiliation': 'Institute for Medicinal Plant Research ""Dr Josif Pančić"", 11000 Belgrade, Serbia.'}, {'ForeName': 'Dubravka', 'Initials': 'D', 'LastName': 'Bigović', 'Affiliation': 'Institute for Medicinal Plant Research ""Dr Josif Pančić"", 11000 Belgrade, Serbia.'}, {'ForeName': 'Nađa', 'Initials': 'N', 'LastName': 'Vasiljević', 'Affiliation': 'Institute of Hygiene and Medical Ecology, Faculty of Medicine University of Belgrade, 11000 Belgrade, Serbia.'}]",Reviews in cardiovascular medicine,['10.31083/j.rcm2302057']
2899,35229427,"Effectiveness and safety of teneligliptin added to patients with type 2 diabetes inadequately controlled by oral triple combination therapy: A multicentre, randomized, double-blind, and placebo-controlled study.","AIM


To investigate the effectiveness and safety of teneligliptin over placebo in patients with type 2 diabetes (T2D) inadequately controlled by triple therapy.
MATERIALS AND METHODS


This trial was a prospective, multicentre, randomized, 12-week double-blind, and placebo-controlled study. The double-blind period was followed by a 24-week open-label clinical trial. One hundred patients with T2D who failed to achieve the glycaemic target (7.1% ≤ HbA1c ≤ 9.0%) with conventional triple oral anti-diabetic drugs (OADs) of metformin, sulphonylurea, and sodium-glucose cotransporter-2 inhibitor (SGLT2i) were assigned randomly 1:1 into teneligliptin and placebo-teneligliptin groups. The primary endpoint was mean change in HbA1c level from baseline in each group at 12 weeks.
RESULTS


In a total of 99 patients (n= 51 for the teneligliptin group, and n=48 for the placebo-teneligliptin group), the mean age and duration of diabetes were 60.7 and 13.6 years, respectively, and HbA1c was 7.8% at baseline. At 12 weeks, the teneligliptin group achieved a significant reduction in HbA1c from baseline (-0.9 ± 0.6%, p < 0.001) compared to the placebo group, with an inter-group difference of -0.75% (95% CI [-0.99, -0.51], p<0.001). At the end of the 24-week treatment, both groups showed significant reductions in HbA1c level from baseline (placebo-teneligliptin group, -0.8 ± 0.6% [p<0.001], teneligliptin group, -0.9 ± 0.6% [p < 0.001]), without significant inter-group difference (-0.17%, 95% CI [-0.41, 0.07], p = 0.156). There was no significant difference between groups in rate of adverse events (AEs) (placebo-teneligliptin group, n = 3 [6.3%]; teneligliptin group, n = 11 [11.1%]; p = 0.550), and the safety profiles was favourable in both groups.
CONCLUSIONS


The current study shows that teneligliptin could be a valid option as a fourth OAD for treatment of patients with T2D inadequately controlled with a triple combination of OADs. This article is protected by copyright. All rights reserved.",2022,"There was no significant difference between groups in rate of adverse events (AEs) (placebo-teneligliptin group, n = 3 [6.3%]; teneligliptin group, n = 11 [11.1%]; p = 0.550), and the safety profiles was favourable in both groups.
","['One hundred patients with T2D who failed to achieve the glycaemic target (7.1%\u2009≤\u2009HbA1c ≤\u20099.0%) with conventional triple oral anti-diabetic drugs (OADs) of', 'patients with type 2 diabetes inadequately controlled by', 'patients with type 2 diabetes (T2D', 'patients with T2D inadequately controlled with a triple combination of OADs', '99 patients (n=\u200951 for the teneligliptin group, and n=48 for the']","['teneligliptin', 'teneligliptin over placebo', 'teneligliptin and placebo-teneligliptin groups', 'placebo-teneligliptin', 'placebo', 'metformin, sulphonylurea, and sodium-glucose cotransporter-2 inhibitor (SGLT2i', 'oral triple combination therapy']","['safety profiles', 'HbA1c level', 'mean change in HbA1c level', 'Effectiveness and safety', 'mean age and duration of diabetes', 'rate of adverse events']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",100.0,0.529623,"There was no significant difference between groups in rate of adverse events (AEs) (placebo-teneligliptin group, n = 3 [6.3%]; teneligliptin group, n = 11 [11.1%]; p = 0.550), and the safety profiles was favourable in both groups.
","[{'ForeName': 'Minyoung', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Woo-Je', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Hyeon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Byung-Wan', 'Initials': 'BW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14679']
2900,35229407,Effects of a multimodal approach to food art therapy on people with mild cognitive impairment and mild dementia.,"BACKGROUND


Food art therapy (FAT) has multiple modalities in which cognition, emotion, and social changes are stimulated. The purpose of this study was to design a multimodal approach to a food art therapy (MM-FAT) program and identify its effects on cognitive ability, daily living functioning, depression, self-esteem, self-efficacy, self-expression, and social functioning in individuals with mild cognitive impairment (MCI) and mild dementia by employing a mixed methods research design.
METHODS


The participants included 39 patients from a public dementia care centre in Seoul, Korea. The intervention group, which comprised 20 participants, received 12 MM-FAT sessions 3 times a week for 4 weeks, and the control group, which included 19 participants, received usual care. The MM-FAT program was evaluated based on its effectiveness on cognitive, daily living, emotional, and social functioning outcome measures at three time points using repeated measures analysis of variance. Semi-structured interviews (n = 9) were conducted to evaluate the overall experience of the MM-FAT program and its outcomes.
RESULTS


The findings reveal that MM-FAT has a positive effect on the cognitive, emotional, and social functioning of individuals with MCI and mild dementia. However, there were no enhancements in individuals' daily living functioning, and the lasting effects of the intervention could not be assessed. Cognition and depression increased significantly at the end of the MM-FAT program. Self-expression and self-efficacy were significantly higher in the MM-FAT group than in the control group. The semi-structured interviews revealed improvements in participants' behaviour, communication, and interaction.
CONCLUSION


This mixed methods study focused on individuals with MCI or mild dementia contributes to an understanding of the effectiveness of a FAT program employing a multimodal approach. Despite the COVID-19 pandemic, the study was able to enrich the effects of MM-FAT on cognitive, emotional, and social functioning through qualitative findings.",2022,"However, there were no enhancements in individuals' daily living functioning, and the lasting effects of the intervention could not be assessed.","['individuals with mild cognitive impairment (MCI) and mild dementia', 'people with mild cognitive impairment and mild dementia', 'individuals with MCI or mild dementia', 'participants included 39 patients from a public dementia care centre in Seoul, Korea']","['MM-FAT', 'usual care', 'food art therapy (MM-FAT) program', 'Food art therapy (FAT', '12\u2009MM-FAT sessions', 'multimodal approach to food art therapy']","['cognitive, emotional, and social functioning', 'effectiveness on cognitive, daily living, emotional, and social functioning outcome measures', ""individuals' daily living functioning"", 'Self-expression and self-efficacy', 'cognitive ability, daily living functioning, depression, self-esteem, self-efficacy, self-expression, and social functioning', ""participants' behaviour, communication, and interaction"", 'Cognition and depression']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003827', 'cui_str': 'Art therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0565975', 'cui_str': 'Self-expression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",39.0,0.0374355,"However, there were no enhancements in individuals' daily living functioning, and the lasting effects of the intervention could not be assessed.","[{'ForeName': 'Hyojin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Eunjoo', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Center for Human-Caring Nurse Leaders for the Future, College of Nursing, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Ju Young', 'Initials': 'JY', 'LastName': 'Yoon', 'Affiliation': 'College of Nursing and Research Institute of Nursing Science, Seoul National University, Seoul, South Korea.'}]",Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society,['10.1111/psyg.12822']
2901,35229658,Acupuncture intervention for acute pain in the Emergency Department trial: a consensus process.,"PURPOSE


This document describes the consensus process and intervention for a National Institutes of Health (NIH)-funded multi-site feasibility study utilizing acupuncture for  ACU te pa I n in  T he Emergenc Y  Department (ACUITY). The acupuncture intervention is designed to be flexible and responsive to the most common Emergency Department (ED) scenarios, including trauma, acute pain of the low back, abdomen and/or musculoskeletal system, renal colic and headache.
BACKGROUND


Opioids remain a primary treatment for acute ED pain with attendant risk of adverse effects, addiction liability, diversion and death. Effective/safer options for acute pain are needed. Although acupuncture therapy has shown promise for acute pain in the ED alone or in conjunction with usual care, pragmatic trials are needed to obtain definitive and generalizable evidence.
METHODS


An Acupuncture Advisory Panel was convened that included nine acupuncture experts with 5-44 years of experience in practice and 2-16 years of experience in the acute pain care setting. A modified Delphi process was used with provision of a literature review, surveys of our panel members, three online discussions and email discussion as needed. The STandards for Reporting Interventions in Controlled Trials (STRICTA) checklist was used as a guide.
RESULTS


A responsive acupuncture intervention was agreed on for ACUITY. Session forms were fashioned in REDCap (Research Electronic Data Capture program to capture essential treatment data, assess fidelity and inform our design for a future pragmatic multi-site randomized controlled trial (RCT) of acupuncture in the ED, and for use by other future researchers.
CONCLUSION


Development of a responsive manualization intervention provides the appropriate framework for conducting a future, pragmatic, multi-site, definitive RCT of acupuncture in the ED.
TRIAL REGISTRATION NUMBER


NCT04880733 (ClinicalTrials.gov).",2022,"The acupuncture intervention is designed to be flexible and responsive to the most common Emergency Department (ED) scenarios, including trauma, acute pain of the low back, abdomen and/or musculoskeletal system, renal colic and headache.
",['nine acupuncture experts with 5-44 years of experience in practice and 2-16 years of experience in the acute pain care setting'],"['acupuncture', 'acupuncture therapy', 'I n in  T', 'acupuncture intervention', 'Acupuncture intervention']",[],"[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.233344,"The acupuncture intervention is designed to be flexible and responsive to the most common Emergency Department (ED) scenarios, including trauma, acute pain of the low back, abdomen and/or musculoskeletal system, renal colic and headache.
","[{'ForeName': 'Arya', 'Initials': 'A', 'LastName': 'Nielsen', 'Affiliation': 'Department of Family Medicine and Community Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Juli', 'Initials': 'J', 'LastName': 'Olson', 'Affiliation': 'Department of Veterans Affairs, Central Iowa, Des Moines, IA, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Quesada', 'Affiliation': 'University Hospitals Connor Whole Health, Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Chongbin', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Osher Center for Integrative Medicine at Vanderbilt, Vanderbilt Health, Nashville, TN, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Raskin', 'Affiliation': 'Center for Integrative Medicine, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Bobbee', 'Initials': 'B', 'LastName': 'Vang', 'Affiliation': 'Penny George Institute For Health and Healing, Abbott Northwestern Hospital, Minneapolis, MN, USA.'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Painovich', 'Affiliation': 'Simple.Holistic.Health, Los Alamitos, CA, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Scott', 'Affiliation': 'Tanya I. Edwards, MD Center for Integrative and Lifestyle Medicine at Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Vashir J', 'Initials': 'VJ', 'LastName': 'Xiong', 'Affiliation': 'Integrated Medicine, Advocate Aurora Healthcare, Milwaukee, WI, USA.'}, {'ForeName': 'Jeffery A', 'Initials': 'JA', 'LastName': 'Dusek', 'Affiliation': 'University Hospitals Connor Whole Health, Cleveland Medical Center, Cleveland, OH, USA.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/09645284221076507']
2902,35229631,The Impact of Ureteral Access Sheath Size on Perioperative Parameters and Postoperative Ureteral Stricture in Retrograde Intrarenal Surgery.,"OBJECTIVE


To investigate the effect of the diameter of UAS used during RIRS on operative parameters, perioperative ureteral injury, and ureteral stricture development.
MATERIAL AND METHOD


The study was designed as a prospective randomized controlled trial and included 320 patients who underwent RIRS. The patients were divided into two groups according to UAS diameter (9.5/11.5 Fr (Group 1) and 12/14 Fr (Group 2)) were used during the operation. At the end of the operation, ureteral injury was checked visually using semi-rigid ureterorenoscopy and classified according to the ureter injury scale. In the postoperative first year, the control CT urography images used to newly developed ureteral dilation.
RESULTS


There was no statistical difference between the two groups in terms of patient and stone characteristics, operative time, postoperative stone-free rate, and postoperative infection development parameters. In Group 1, 30 (18.8%) of the patients had low-grade and 8 (5%) of the patients had high-grade ureteral injury while in Group 2, 44 (27.5%) had low-grade and 19 (11.9%) had high-grade ureteral injury (p=0.013). In the postoperative period, ureteral stricture was found in 5 (1.6%) patients, of whom 4 (2.5%) were in Group 2 and 1 (0.6%) (p=0.371).
CONCLUSION


The results of our study showed that the use of a 12/14 Fr UAS in patients who are not previously stented, increases the risk of high grade ureteral injuries, however, despite this increase there is no difference in ureteral stricture formation.",2022,"There was no statistical difference between the two groups in terms of patient and stone characteristics, operative time, postoperative stone-free rate, and postoperative infection development parameters.",['320 patients who underwent RIRS'],[],"['high-grade ureteral injury', 'patient and stone characteristics, operative time, postoperative stone-free rate, and postoperative infection development parameters', 'ureteral stricture formation', 'ureteral stricture', 'risk of high grade ureteral injuries', 'operative parameters, perioperative ureteral injury, and ureteral stricture development']","[{'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0238493', 'cui_str': 'Injury of ureter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3887590', 'cui_str': 'Stricture of ureter'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",320.0,0.0243355,"There was no statistical difference between the two groups in terms of patient and stone characteristics, operative time, postoperative stone-free rate, and postoperative infection development parameters.","[{'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Aykanat', 'Affiliation': 'Ankara, Turkey; canaykanat89@gmail.com.'}, {'ForeName': 'Melih', 'Initials': 'M', 'LastName': 'Balci', 'Affiliation': 'Ankara Numune Training and Research Hospital, 64134, Urology, Talatpasa Blv, Ankara, Turkey, 06100; drmelb@hotmail.com.'}, {'ForeName': 'Cagdas', 'Initials': 'C', 'LastName': 'Senel', 'Affiliation': 'numune eğitim ve araştırma hastanesi b blok 3.kat üroloji a kliniğiAnkara, Turkey, 06100; cagdas_senel@hotmail.com.'}, {'ForeName': 'Ali Yasin', 'Initials': 'AY', 'LastName': 'Ozercan', 'Affiliation': 'Ankara, Turkey; aliyasinozerecan@gmail.com.'}, {'ForeName': 'Seref', 'Initials': 'S', 'LastName': 'Coser', 'Affiliation': 'Ankara, Turkey; serefcoser@hotmail.com.'}, {'ForeName': 'Yilmaz', 'Initials': 'Y', 'LastName': 'Aslan', 'Affiliation': 'Ankara, Turkey; urodrya@yahoo.com.'}, {'ForeName': 'Ozer', 'Initials': 'O', 'LastName': 'Guzel', 'Affiliation': 'Ankara, Turkey; drozerguzel@gmail.com.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Asfuroglu', 'Affiliation': 'Ankara, Turkey; ahmetasfur@hotmail.com.'}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Karabulut', 'Affiliation': 'Hacettepe University Faculty of Medicine, 64005, Biostatistics, Ankara, Ankara, Turkey; ekarabul@hacettepe.edu.tr.'}, {'ForeName': 'Altug', 'Initials': 'A', 'LastName': 'Tuncel', 'Affiliation': 'Ankara Numune Research and Training Hospital, urology, Sihhiye, Ankara, Turkey, 06120.'}]",Journal of endourology,['10.1089/end.2021.0751']
2903,35229627,Preoperative electroacupuncture for postoperative nausea and vomiting in laparoscopic gynecological surgery: a randomized controlled trial.,"OBJECTIVE


We aimed to evaluate the effectiveness and safety of preoperative electroacupuncture (EA) on the incidence of postoperative nausea and vomiting (PONV), and severity of postoperative pain, in gynecological patients undergoing laparoscopic surgery. The effects of EA administered at different preoperative time points were compared.
METHODS


A total of 413 patients undergoing elective laparoscopic gynecological surgery were randomly allocated into 4 groups receiving EA the day before surgery (Group Pre, n = 103), 30 min before (Group 30, n = 104) or both (Group Comb, n = 103), or usual care alone (Group Usual, n = 103). All acupuncture groups had usual care. The incidence of PONV and pain at 24 h were primary outcomes. Secondary outcomes included the severity of postoperative nausea, vomiting and pain, requirement for antiemetic medication and quality of recovery (QoR)-15 scores after surgery.
RESULTS


There were significant differences between the four groups in nausea and vomiting incidence (0-24 h), postoperative antiemetic use (0-48 h), and postoperative pain (0-6 h), with the EA groups recording the lowest levels. Regarding primary outcomes, incidence of nausea and vomiting at 6-24 h was 28/11/18/11% (p = 0.003) 23/5/8/9% (p < 0.001), respectively, for Groups Usual/Pre/30/Comb. Accordingly, EA reduced the incidence of nausea and vomiting at 6-24 h by 61/34/60% and 79/65/61% for Groups Pre/30/Comb, respectively. Regarding secondary outcomes, incidence of nausea and vomiting at 0-6 h was 20/9/11/7% (p = 0.013) and 17/7/9/6% (p = 0.021), respectively, for Groups Usual/Pre/30/Comb. Rescue antiemetics at 0-6 h were required by 18/4/11/4% (p = 0.001) in Groups Usual/Pre/30/Comb. The mean numerical rating scale (NRS) pain score (0-10) at 0-6 h was significantly different between groups (2.45/1.89/2.01/1.97 for Groups Usual/Pre/30/Comb, p = 0.024). There were no significant differences between the three EA-treated groups.
CONCLUSION


In gynecological patients undergoing laparoscopic surgery and treated with multimodal antiemetic methods, one session of preoperative EA may be a safe adjunctive treatment for PONV prophylaxis. Optimal timing of EA requires further verification.
TRIAL REGISTRATION NUMBER


ChiCTR-INR-16010035 (Chinese Clinical Trial Registry).",2022,"There were significant differences between the four groups in nausea and vomiting incidence (0-24 h), postoperative antiemetic use (0-48 h), and postoperative pain (0-6 h), with the EA groups recording the lowest levels.","['laparoscopic gynecological surgery', 'gynecological patients undergoing laparoscopic surgery', '413 patients undergoing elective laparoscopic gynecological surgery', 'gynecological patients undergoing']","['laparoscopic surgery', 'preoperative electroacupuncture (EA', 'EA', 'Preoperative electroacupuncture', 'usual care alone']","['mean numerical rating scale (NRS) pain score', 'severity of postoperative nausea, vomiting and pain, requirement for antiemetic medication and quality of recovery (QoR)-15 scores after surgery', 'nausea and vomiting', 'postoperative pain', 'incidence of nausea and vomiting', 'nausea and vomiting incidence', 'postoperative antiemetic use', 'incidence of PONV and pain', 'postoperative nausea and vomiting', 'postoperative nausea and vomiting (PONV), and severity of postoperative pain', 'Rescue antiemetics']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]",413.0,0.284481,"There were significant differences between the four groups in nausea and vomiting incidence (0-24 h), postoperative antiemetic use (0-48 h), and postoperative pain (0-6 h), with the EA groups recording the lowest levels.","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Wenzhong', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Acupuncture, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Xiaoqiu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Key Laboratory of Acupuncture and Medicine Research of Ministry of Education, College of Pharmacy, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Fangbing', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zou', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Discipline of Chinese Medicine, School of Health and Biomedical Sciences, World Health Organization Collaborating Centre for Traditional Medicine, RMIT University, Melbourne, VIC, Australia.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/09645284221076517']
2904,35229621,Structured Lifestyle Modification Interventions Involving Frontline Health Workers for Population-Level Blood Pressure Reduction: Results of a Cluster Randomized Controlled Trial in India (DISHA Study).,"Background Population-wide reduction in mean blood pressure is proposed as a key strategy for primary prevention of cardiovascular disease. We evaluated the effectiveness of a task-sharing strategy involving frontline health workers in the primary prevention of elevated blood pressure. Methods and Results We conducted DISHA (Diet and lifestyle Interventions for Hypertension Risk reduction through Anganwadi Workers and Accredited Social Health Activists) study, a cluster randomized controlled trial involving 12 villages each from 4 states in India. Frontline health workers delivered a custom-made and structured lifestyle modification intervention in the selected villages. A baseline survey was conducted in 23 and 24 clusters in the control (n=6663) and intervention (n=7150) groups, respectively. The baseline characteristics were similar between control and intervention clusters. In total 5616 participants from 23 clusters in the control area and 5699 participants from 24 clusters in the intervention area participated in a repeat cross-sectional survey conducted immediately after the intervention phase of 18-months. The mean (SD) systolic blood pressure increased from 125.7 (18.1) mm Hg to 126.1 (16.8) mm Hg in the control clusters, and it increased from 124.4 (17.8) mm Hg to 126.7 (17.5) mm Hg in the intervention clusters. The population average adjusted mean difference in difference in systolic blood pressure was 1.75 mm Hg (95% CI, -0.21 to 3.70). Conclusions Task-sharing interventions involving minimally trained nonphysician health workers are not effective in reducing population average blood pressure in India. Expanding the scope of task sharing and intensive training of health workers such as nurses, nutritionists, or health counselors in management of cardiovascular risk at the population level may be more effective in primary prevention of cardiovascular disease. Registration URL: https://www.ctri.nic.in; Unique identifier: CTRI/2013/10/004049.",2022,Conclusions Task-sharing interventions involving minimally trained nonphysician health workers are not effective in reducing population average blood pressure in India.,"['In total 5616 participants from 23 clusters in the control area and 5699 participants from 24 clusters in the intervention area participated in a repeat cross-sectional survey conducted immediately after the intervention phase of 18-months', '12 villages each from 4 states in India', 'frontline health workers in the primary prevention of elevated blood pressure', '23 and 24 clusters in the control (n=6663) and intervention (n=7150) groups, respectively']","['custom-made and structured lifestyle modification intervention', 'Structured Lifestyle Modification Interventions', 'DISHA (Diet and lifestyle Interventions']","['Population-Level Blood Pressure Reduction', 'systolic blood pressure', 'mean (SD) systolic blood pressure']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",12.0,0.169058,Conclusions Task-sharing interventions involving minimally trained nonphysician health workers are not effective in reducing population average blood pressure in India.,"[{'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Kondal', 'Affiliation': 'Public Health Foundation of India Centre for Control of Chronic Conditions Gurugram Haryana India.'}, {'ForeName': 'Panniyammakal', 'Initials': 'P', 'LastName': 'Jeemon', 'Affiliation': 'Centre for Chronic Disease Control New Delhi India.'}, {'ForeName': 'Sathyaprakash', 'Initials': 'S', 'LastName': 'Manimunda', 'Affiliation': 'National Centre for Disease Informatics and ResearchICMR Bengaluru India.'}, {'ForeName': 'Gitanjali', 'Initials': 'G', 'LastName': 'Narayanan', 'Affiliation': 'National Institute of Mental Health and Neurosciences Bangalore India.'}, {'ForeName': 'Anil Jacob', 'Initials': 'AJ', 'LastName': 'Purty', 'Affiliation': 'Pondicherry Institute of Medical Science Kalapet Puducherry India.'}, {'ForeName': 'Prakash Chand', 'Initials': 'PC', 'LastName': 'Negi', 'Affiliation': 'Indira Gandhi Medical College Shimla Himachal Pradesh India.'}, {'ForeName': 'Sulaiman Sadruddin', 'Initials': 'SS', 'LastName': 'Ladhani', 'Affiliation': 'Aga Khan Health Services Mumbai Maharashtra India.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Sanghvi', 'Affiliation': 'Sri Aurbindo Institute of Medical Sciences Indore Madhya Pradesh India.'}, {'ForeName': 'Kuldeep', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'All India Institute of Medical Sciences Jodhpur India.'}, {'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Deshpande', 'Affiliation': 'Sri Aurbindo Institute of Medical Sciences Indore Madhya Pradesh India.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Sobti', 'Affiliation': 'Centre for Chronic Disease Control New Delhi India.'}, {'ForeName': 'Gurudayal Singh', 'Initials': 'GS', 'LastName': 'Toteja', 'Affiliation': 'Indian Council of Medical Research New Delhi India.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Public Health Foundation of India Centre for Control of Chronic Conditions Gurugram Haryana India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.121.023526']
2905,35230254,Home Telemonitoring of Arterial Hypertension With Antihypertensive Treatment Titration: Protocol for a Randomized Controlled Prospective Trial (HOROSCOPE Study).,"BACKGROUND


Despite the availability of effective treatment, the control of hypertension remains insufficient. Telemonitoring in the management of hypertension would be an effective way to improve blood pressure control.
OBJECTIVE


The aim of our study will be to evaluate the effects of telemonitoring with antihypertensive treatment titration on blood pressure control in Tunisian patients with hypertension.
METHODS


Our trial will be a prospective, rater-blinded randomized controlled trial carried out with primary care physicians in the Sahel region of Tunisia. Patients will be eligible for enrollment if they are aged over 35 years, are newly diagnosed with hypertension, or are known to be poorly controlled on antihypertensive therapy. Participants will be randomly assigned in a 1:1 ratio to the telemonitoring arm or usual care arm. The telemonitoring arm will involve a weekly telephone call for the collection of the home blood pressure measurements, therapeutic education, and treatment compliance assessment as well as a monthly call for treatment titration and a side effect check. Randomization will be done via the use of an interactive web responsive system, and patients will be stratified by investigation center. Neither participants nor investigators will be masked to the group assignments. The primary outcome will be the change in mean 24-hour systolic blood pressure from baseline to the 6-month follow-up in the 2 groups. All randomized patients who attend the follow-up visit at 6 months and have no missing data for the primary outcome will be included in the analysis.
RESULTS


Recruitment to the trial started in July 2020. The study was initiated with 17 primary care physicians. We expect the inclusion period to last for approximately 6 months. We expect to complete data collection by the end of 2021 and plan to disseminate the results subsequently.
CONCLUSIONS


The HOROSCOPE (Home Telemonitoring of Arterial Hypertension With Antihypertensive Treatment Titration: Randomized Controlled Prospective Trial) study will provide important new evidence that could shed some light on the feasibility and impact of telemonitoring and self-monitoring in a Tunisian population of patients with hypertension who consult primary care physicians.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04607239; https://clinicaltrials.gov/ct2/show/NCT04607239.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/26184.",2022,"All randomized patients who attend the follow-up visit at 6 months and have no missing data for the primary outcome will be included in the analysis.
","['Tunisian population of patients with hypertension who consult primary care physicians', '17 primary care physicians', 'Tunisian patients with hypertension', 'Patients will be eligible for enrollment if they are aged over 35 years, are newly diagnosed with hypertension, or are known to be poorly controlled on antihypertensive therapy', 'primary care physicians in the Sahel region of Tunisia']","['Antihypertensive Treatment Titration', 'telemonitoring arm or usual care arm', 'telemonitoring and self-monitoring', 'telemonitoring with antihypertensive treatment titration']","['mean 24-hour systolic blood pressure', 'blood pressure control']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041388', 'cui_str': 'Tunisia'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1282174', 'cui_str': '24 hour systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0840145,"All randomized patients who attend the follow-up visit at 6 months and have no missing data for the primary outcome will be included in the analysis.
","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Ben Hafaiedh', 'Affiliation': 'Medical Department, MédiS Laboratories, Tunis, Tunisia.'}, {'ForeName': 'Yosra', 'Initials': 'Y', 'LastName': 'Ben Daya', 'Affiliation': 'Medical Department, MédiS Laboratories, Tunis, Tunisia.'}, {'ForeName': 'Amina Hadjer', 'Initials': 'AH', 'LastName': 'Radoui', 'Affiliation': 'Medical Department, MédiS Laboratories, Tunis, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bouchoucha', 'Affiliation': 'Medical Department, MédiS Laboratories, Tunis, Tunisia.'}, {'ForeName': 'Rabie', 'Initials': 'R', 'LastName': 'Razgallah', 'Affiliation': 'Dacima, Tunis, Tunisia.'}, {'ForeName': 'Semir', 'Initials': 'S', 'LastName': 'Nouira', 'Affiliation': 'Emergency Department and Laboratory Research (LR12SP18), Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}]",JMIR research protocols,['10.2196/26184']
2906,35230249,Tracking Demographic Movements and Immunization Status to Improve Children's Access to Immunization: Field-Based Randomized Controlled Trial.,"BACKGROUND


Countries' Expanded Program on Immunization (EPI) contribute to the reduction of mortality and morbidity, but access to these vaccines remains limited in most low-income countries.
OBJECTIVE


We aim to assess whether involving community volunteers (CVs) to track children's vaccination status and demographic movements and using recorded data to plan catch-up immunization sessions can improve children's vaccination timeliness, completeness, and coverage.
METHODS


This was a field-based randomized controlled trial and communities of the Foumban health district in West Cameroon were allocated to intervention or control groups. In the intervention group, a CV per community was trained to visit households monthly for a year to assess and record in a register, details of EPI-targeted children, their demographic movements and immunization status. The scanned recorded pages were sent to the health center immunization team through WhatsApp and used to organize monthly community catch-up immunization sessions. In the control group, EPI vaccination sessions were routinely conducted. Surveys were conducted at 6 and 12 months from the beginning of the intervention in both study groups to assess and compare immunization timeliness, coverage, and completeness.
RESULTS


Overall, 30 buildings per cluster were surveyed at midline and endline. Of the 633 and 729 visited households in the intervention group at midline and endline, 630 (99.5%) and 718 (98.4%), respectively, consented to participate. In the control group, 507 and 651 households were visited and 505 (99.6%) and 636 (97.7%), respectively, consented to participate. At 12 months intervention, the month one timeliness of bacille Calmette-Guerin (BCG) vaccine did not increase in the intervention group compared with the control group for the age groups 0-11 months (adjusted odds ratio [aOR] 1.1, 95% CI 0.7-1.8) and 0-59 months (aOR 1.1, 95% CI 0.9-1.4), and significantly increased for the first-year BCG vaccine administration for the age group 0-23 months (aOR 1.5, 95% CI 1.1-2.2). The coverage of diphtheria-pertussis-tetanus and hepatitis B+Hemophilus influenzae type B (DPT-Hi +Hb) dose 3 (aOR 2.0, 95% CI 1.5-2.7) and of DPT-Hi+Hb dose 1 (aOR 1.8, 95% CI 1.4-2.4) vaccines increased significantly in the intervention group compared with the control group in the age groups 12-59 months and 12-23 months, respectively. Specific (DPT-Hi+Hb dose 1 to DPT-Hi+Hb dose 3: aOR 1.9, 95% CI 1.4-2.6) and general (BCG to measles: aOR 1.5, 95% CI 1.1-2.1) vaccine completeness increased significantly in the intervention group compared with the control group.
CONCLUSIONS


Findings support that involving CVs to track children's vaccination status and demographic movements and using recorded data to plan catch-up immunization sessions improve children's vaccination timeliness, completeness, and coverage. This strategy should be adopted to improve access to vaccination for EPI target populations and the consistency verified in other contexts.
TRIAL REGISTRATION


Pan African Clinical Trials Registry PACTR201808527428720; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3548.",2022,"aOR 1.5, 95% CI 1.1-2.1) vaccine completeness increased significantly in the intervention group compared with the control group.
","['Of the 633 and 729 visited households in the intervention group at midline and endline, 630 (99.5%) and 718 (98.4%), respectively, consented to participate', 'communities of the Foumban health district in West Cameroon', '507 and 651 households were visited and 505 (99.6%) and 636 (97.7%), respectively, consented to participate']",['diphtheria-pertussis-tetanus and hepatitis B+Hemophilus influenzae type B (DPT-Hi\u2009+Hb'],"[""children's vaccination timeliness, completeness, and coverage"", 'bacille Calmette-Guerin (BCG) vaccine', 'vaccine completeness', 'immunization timeliness, coverage, and completeness']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C4517912', 'cui_str': '99.5'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0450381', 'cui_str': '507'}]","[{'cui': 'C0012546', 'cui_str': 'Diphtheria'}, {'cui': 'C0031237', 'cui_str': 'Pertussis Vaccine'}, {'cui': 'C0039614', 'cui_str': 'Tetanus'}, {'cui': 'C0019158', 'cui_str': 'Inflammatory disease of liver'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}]",,0.153386,"aOR 1.5, 95% CI 1.1-2.1) vaccine completeness increased significantly in the intervention group compared with the control group.
","[{'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Ateudjieu', 'Affiliation': 'Department of Health Research, Meilleur Accès Aux Soins de Santé (M.A.SANTE), Yaounde, Cameroon.'}, {'ForeName': 'Ketina Hirma', 'Initials': 'KH', 'LastName': 'Tchio-Nighie', 'Affiliation': 'Department of Health Research, Meilleur Accès Aux Soins de Santé (M.A.SANTE), Yaounde, Cameroon.'}, {'ForeName': 'André Pascal', 'Initials': 'AP', 'LastName': 'Goura', 'Affiliation': 'Department of Health Research, Meilleur Accès Aux Soins de Santé (M.A.SANTE), Yaounde, Cameroon.'}, {'ForeName': 'Martin Yakum', 'Initials': 'MY', 'LastName': 'Ndinakie', 'Affiliation': 'Department of Health Research, Meilleur Accès Aux Soins de Santé (M.A.SANTE), Yaounde, Cameroon.'}, {'ForeName': 'Miltiade', 'Initials': 'M', 'LastName': 'Dieffi Tchifou', 'Affiliation': 'Department of Public Health, Faculty of Medecine and Pharmaceutical Sciences, University of Dschang, Dschang, Cameroon.'}, {'ForeName': 'Lapia', 'Initials': 'L', 'LastName': 'Amada', 'Affiliation': 'Department of Health Research, Meilleur Accès Aux Soins de Santé (M.A.SANTE), Yaounde, Cameroon.'}, {'ForeName': 'Marcelin', 'Initials': 'M', 'LastName': 'Tsafack', 'Affiliation': 'Department of Health Research, Meilleur Accès Aux Soins de Santé (M.A.SANTE), Yaounde, Cameroon.'}, {'ForeName': 'Frank Forex', 'Initials': 'FF', 'LastName': 'Kiadjieu Dieumo', 'Affiliation': 'Department of Health Research, Meilleur Accès Aux Soins de Santé (M.A.SANTE), Yaounde, Cameroon.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Guenou', 'Affiliation': 'Department of Health Research, Meilleur Accès Aux Soins de Santé (M.A.SANTE), Yaounde, Cameroon.'}, {'ForeName': 'Charlette', 'Initials': 'C', 'LastName': 'Nangue', 'Affiliation': 'Department of Health Research, Meilleur Accès Aux Soins de Santé (M.A.SANTE), Yaounde, Cameroon.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Kenfack', 'Affiliation': 'Department of Gynecology and Obstetrics, Faculty of Medicine and Pharmaceutical Sciences, University of Dschang, Dschang, Cameroon.'}]",JMIR public health and surveillance,['10.2196/32213']
2907,35230245,Increasing the Effectiveness of a Physical Activity Smartphone Intervention With Positive Suggestions: Randomized Controlled Trial.,"BACKGROUND


eHealth interventions have the potential to increase the physical activity of users. However, their effectiveness varies, and they often have only short-term effects. A possible way of enhancing their effectiveness is to increase the positive outcome expectations of users by giving them positive suggestions regarding the effectiveness of the intervention. It has been shown that when individuals have positive expectations regarding various types of interventions, they tend to benefit from these interventions more.
OBJECTIVE


The main objective of this web-based study is to investigate whether positive suggestions can change the expectations of participants regarding the effectiveness of a smartphone physical activity intervention and subsequently enhance the number of steps the participants take during the intervention. In addition, we study whether suggestions affect perceived app effectiveness, engagement with the app, self-reported vitality, and fatigue of the participants.
METHODS


This study involved a 21-day fully automated physical activity intervention aimed at helping participants to walk more steps. The intervention was delivered via a smartphone-based app that delivered specific tasks to participants (eg, setting activity goals or looking for social support) and recorded their daily step count. Participants were randomized to either a positive suggestions group (69/133, 51.9%) or a control group (64/133, 48.1%). Positive suggestions emphasizing the effectiveness of the intervention were implemented in a web-based flyer sent to the participants before the intervention. Suggestions were repeated on days 8 and 15 of the intervention via the app.
RESULTS


Participants significantly increased their daily step count from baseline compared with 21 days of the intervention (t 107 =-8.62; P<.001) regardless of the suggestions. Participants in the positive suggestions group had more positive expectations regarding the app (B=-1.61, SE 0.47; P<.001) and higher expected engagement with the app (B=3.80, SE 0.63; P<.001) than the participants in the control group. No effects of suggestions on the step count (B=-22.05, SE 334.90; P=.95), perceived effectiveness of the app (B=0.78, SE 0.69; P=.26), engagement with the app (B=0.78, SE 0.75; P=.29), and vitality (B=0.01, SE 0.11; P=.95) were found. Positive suggestions decreased the fatigue of the participants during the 3 weeks of the intervention (B=0.11, SE 0.02; P<.001).
CONCLUSIONS


Although the suggestions did not affect the number of daily steps, they increased the positive expectations of the participants and decreased their fatigue. These results indicate that adding positive suggestions to eHealth physical activity interventions might be a promising way of influencing subjective but not objective outcomes of interventions. Future research should focus on finding ways of strengthening the suggestions, as they have the potential to boost the effectiveness of eHealth interventions.
TRIAL REGISTRATION


Open Science Framework 10.17605/OSF.IO/CWJES; https://osf.io/cwjes.",2022,"Participants in the positive suggestions group had more positive expectations regarding the app (B=-1.61, SE 0.47; P<.001) and higher expected engagement with the app (B=3.80, SE 0.63; P<.001) than the participants in the control group.",[],"['smartphone-based app that delivered specific tasks to participants (eg, setting activity goals or looking for social support', 'physical activity intervention', 'smartphone physical activity intervention', 'Physical Activity Smartphone Intervention']","['daily step count', 'fatigue', 'positive expectations', 'number of daily steps', 'vitality']",[],"[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0668903,"Participants in the positive suggestions group had more positive expectations regarding the app (B=-1.61, SE 0.47; P<.001) and higher expected engagement with the app (B=3.80, SE 0.63; P<.001) than the participants in the control group.","[{'ForeName': 'Aleksandrina', 'Initials': 'A', 'LastName': 'Skvortsova', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Cohen Rodrigues', 'Affiliation': 'Health, Medical and Neuropsychology, Faculty of Social and Behavioural Sciences, Leiden, Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'de Buisonjé', 'Affiliation': 'Health, Medical and Neuropsychology, Faculty of Social and Behavioural Sciences, Leiden, Netherlands.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kowatsch', 'Affiliation': 'Centre for Digital Health Interventions, Department of Management, Technology, and Economics, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Prabhakaran', 'Initials': 'P', 'LastName': 'Santhanam', 'Affiliation': 'Centre for Digital Health Interventions, Department of Management, Technology, and Economics, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Dieuwke S', 'Initials': 'DS', 'LastName': 'Veldhuijzen', 'Affiliation': 'Health, Medical and Neuropsychology, Faculty of Social and Behavioural Sciences, Leiden, Netherlands.'}, {'ForeName': 'Henriët', 'Initials': 'H', 'LastName': 'van Middendorp', 'Affiliation': 'Health, Medical and Neuropsychology, Faculty of Social and Behavioural Sciences, Leiden, Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Evers', 'Affiliation': 'Health, Medical and Neuropsychology, Faculty of Social and Behavioural Sciences, Leiden, Netherlands.'}]",Journal of medical Internet research,['10.2196/32130']
2908,35230243,Usability Testing and Technology Acceptance of an mHealth App at the Point of Care During Simulated Pediatric In- and Out-of-Hospital Cardiopulmonary Resuscitations: Study Nested Within 2 Multicenter Randomized Controlled Trials.,"BACKGROUND


Mobile apps are increasingly being used in various domains of medicine. Few are evidence-based, and their benefits can only be achieved if end users intend to adopt and use them. To date, only a small fraction of mobile apps have published data on their field usability and end user acceptance results, especially in emergency medicine.
OBJECTIVE


This study aims to determine the usability and acceptance of an evidence-based mobile app while safely preparing emergency drugs at the point of care during pediatric in- and out-of-hospital cardiopulmonary resuscitations by frontline caregivers.
METHODS


In 2 multicenter randomized controlled parent trials conducted at 6 pediatric emergency departments from March 1 to December 31, 2017, and 14 emergency medical services from September 3, 2019, to January 21, 2020, the usability and technology acceptance of the PedAMINES (Pediatric Accurate Medication in Emergency Situations) app were evaluated among skilled pediatric emergency nurses and advanced paramedics when preparing continuous infusions of vasoactive drugs and direct intravenous emergency drugs at pediatric dosages during standardized, simulation-based, pediatric in- and out-of-hospital cardiac arrest scenarios, respectively. Usability was measured using the 10-item System Usability Scale. A 26-item technology acceptance self-administered survey (5-point Likert-type scales), adapted from the Unified Theory of Acceptance and Use of Technology model, was used to measure app acceptance and intention to use.
RESULTS


All 100% (128/128) of nurses (crossover trial) and 49.3% (74/150) of paramedics (parallel trial) were assigned to the mobile app. Mean total scores on the System Usability Scale were excellent and reached 89.5 (SD 8.8; 95% CI 88.0-91.1) for nurses and 89.7 (SD 8.7; 95% CI 87.7-91.7) for paramedics. Acceptance of the technology was very good and rated on average >4.5/5 for 5 of the 8 independent constructs evaluated. Only the image construct scored between 3.2 and 3.5 by both participant populations.
CONCLUSIONS


The results provide evidence that dedicated mobile apps can be easy to use and highly accepted at the point of care during in- and out-of-hospital cardiopulmonary resuscitations by frontline emergency caregivers. These findings can contribute to the implementation and valorization of studies aimed at evaluating the usability and acceptance of mobile apps in the field by caregivers, even in critical situations.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03021122; https://clinicaltrials.gov/ct2/show/NCT03021122. ClinicalTrials.gov NCT03921346; https://clinicaltrials.gov/ct2/show/NCT03921346.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s13063-019-3726-4.",2022,All 100% (128/128) of nurses (crossover trial) and 49.3% (74/150) of paramedics (parallel trial) were assigned to the mobile app.,"['6 pediatric emergency departments from March 1 to December 31, 2017, and 14 emergency medical services from September 3, 2019, to January 21, 2020, the usability and technology acceptance of the PedAMINES (Pediatric Accurate Medication in Emergency Situations) app were evaluated among skilled pediatric emergency nurses and advanced paramedics when preparing continuous infusions of vasoactive drugs and direct intravenous emergency drugs at pediatric dosages during standardized, simulation-based, pediatric in- and out-of-hospital cardiac arrest scenarios, respectively', 'Care During Simulated Pediatric In- and Out-of-Hospital Cardiopulmonary Resuscitations']",[],"['10-item System Usability Scale', 'Mean total scores on the System Usability Scale', 'Usability']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]",[],"[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.177231,All 100% (128/128) of nurses (crossover trial) and 49.3% (74/150) of paramedics (parallel trial) were assigned to the mobile app.,"[{'ForeName': 'Johan N', 'Initials': 'JN', 'LastName': 'Siebert', 'Affiliation': ""Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Laëtitia', 'Initials': 'L', 'LastName': 'Gosetto', 'Affiliation': 'Diagnostic Department, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Sauvage', 'Affiliation': 'Diagnostic Department, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Bloudeau', 'Affiliation': 'A.C.E. Geneva Ambulances SA, Geneva, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Suppan', 'Affiliation': 'Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Rodieux', 'Affiliation': 'Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haddad', 'Affiliation': ""Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Hugon', 'Affiliation': ""Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Gervaix', 'Affiliation': ""Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lovis', 'Affiliation': 'Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Combescure', 'Affiliation': 'Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Manzano', 'Affiliation': ""Department of Pediatric Emergency Medicine, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Ehrler', 'Affiliation': 'Diagnostic Department, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'See Acknowledgments, .'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'See Acknowledgments, .'}]",JMIR human factors,['10.2196/35399']
2909,35230676,Effects of transcranial direct current stimulation on physical and mental health in older adults with chronic musculoskeletal pain: a randomized controlled trial.,"PURPOSE


We investigated the effects of transcranial direct current stimulation (tDCS) combined with physical therapy (PT) on pain levels, physical activity levels, quality of life, and depression in older adults with chronic musculoskeletal pain.
METHODS


Twenty-five older adults (9 males and 16 females), aged between 66 and 86 years (active group 77.2 ± 3.9; sham group 76.6 ± 6.2), volunteers were randomly allocated in the active (active tDCS + PT) and sham groups (sham tDCS + PT), and received the intervention three times per week for 8 weeks. Pain level, physical activity level, depression state, and quality of life were assessed based on the Visual Analog Scale (VAS), Physical Activity Scale for the Elderly (PASE), Beck Depression Inventory (BDI) scale, and Short-Form 36 Health Survey Questionnaire (SF-36), respectively. Measurements were conducted four times: at baseline, mid-intervention, post-intervention, and 1-month follow-up.
RESULTS


As a result, at 8 weeks, the active group yielded greater improvements in VAS, BDI, and SF-36 scores than the sham tDCS group. At follow-up, the tDCS group led to a greater improvement in VAS, PASE, and SF-36 scores compared to sham tDCS group (p < 0.05).
CONCLUSION


Our results suggest a beneficial effect of tDCS combined with PT in older adults with chronic musculoskeletal pain in the reduction of pain sensation, increment of physical activity level, increment of the quality of life, and reduction of depression incidents. This opens the possibility the possibility of using tDCS as a regular treatment for this population's physical and mental health.",2022,"At follow-up, the tDCS group led to a greater improvement in VAS, PASE, and SF-36 scores compared to sham tDCS group (p < 0.05).
","['older adults with chronic musculoskeletal pain', 'Twenty-five older adults (9 males and 16 females), aged between 66 and 86\xa0years (active group 77.2\u2009±\u20093.9; sham group 76.6\u2009±\u20096.2), volunteers']","['transcranial direct current stimulation (tDCS) combined with physical therapy (PT', 'tDCS', 'transcranial direct current stimulation', 'active (active tDCS\u2009+\u2009PT) and sham groups (sham tDCS\u2009+\u2009PT', 'tDCS combined with PT']","['VAS, BDI, and SF-36 scores', 'Visual Analog Scale (VAS), Physical Activity Scale for the Elderly (PASE), Beck Depression Inventory (BDI) scale, and Short-Form 36 Health Survey Questionnaire (SF-36', 'quality of life, and reduction of depression incidents', 'VAS, PASE, and SF-36 scores', 'Pain level, physical activity level, depression state, and quality of life', 'pain levels, physical activity levels, quality of life, and depression', 'pain sensation, increment of physical activity level', 'physical and mental health']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",25.0,0.0804564,"At follow-up, the tDCS group led to a greater improvement in VAS, PASE, and SF-36 scores compared to sham tDCS group (p < 0.05).
","[{'ForeName': 'Seungmin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Major of Rehabilitation Science, Graduate School, College of Health Science, Korea University, Hana Science Hall, Anam-dong-5-ga, Sungbuk-Gu, Seoul, 136-703, Republic of Korea.'}, {'ForeName': 'Jhosedyn Carolaym', 'Initials': 'JC', 'LastName': 'Salazar Fajardo', 'Affiliation': 'Major of Rehabilitation Science, Graduate School, College of Health Science, Korea University, Hana Science Hall, Anam-dong-5-ga, Sungbuk-Gu, Seoul, 136-703, Republic of Korea.'}, {'ForeName': 'Eunyoung', 'Initials': 'E', 'LastName': 'Seo', 'Affiliation': 'Major of Rehabilitation Science, Graduate School, College of Health Science, Korea University, Hana Science Hall, Anam-dong-5-ga, Sungbuk-Gu, Seoul, 136-703, Republic of Korea.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Major of Rehabilitation Science, Graduate School, College of Health Science, Korea University, Hana Science Hall, Anam-dong-5-ga, Sungbuk-Gu, Seoul, 136-703, Republic of Korea.'}, {'ForeName': 'Rockhyun', 'Initials': 'R', 'LastName': 'Kim', 'Affiliation': 'Major of Rehabilitation Science, Graduate School, College of Health Science, Korea University, Hana Science Hall, Anam-dong-5-ga, Sungbuk-Gu, Seoul, 136-703, Republic of Korea.'}, {'ForeName': 'BumChul', 'Initials': 'B', 'LastName': 'Yoon', 'Affiliation': 'Major of Rehabilitation Science, Graduate School, College of Health Science, Korea University, Hana Science Hall, Anam-dong-5-ga, Sungbuk-Gu, Seoul, 136-703, Republic of Korea. yoonbc@korea.ac.kr.'}]",European geriatric medicine,['10.1007/s41999-022-00626-4']
2910,35230622,Targeted Electronic Patient Portal Messaging Increases Hepatitis C Virus Screening in Primary Care: a Randomized Study.,"IMPORTANCE


Electronic health record (EHR) tools such as direct-to-patient messaging and automated lab orders are effective at improving uptake of preventive health measures. It is unknown if patient engagement in primary care impacts efficacy of such messaging.
OBJECTIVE


To determine whether more engaged patients, defined as those who have an upcoming visit scheduled, are more likely to respond to a direct-to-patient message with an automated lab order for hepatitis C virus (HCV) screening.
DESIGN


Randomized trial PARTICIPANTS: One thousand six hundred randomly selected Stanford Primary Care patients, 800 with an upcoming visit within 6 months and 800 without, born between 1945 and 1965 who were due for HCV screening. Each group was randomly divided into cohorts of 400 subjects each. Subjects were followed for 1 year.
INTERVENTION


One 400 subject cohort in each group received a direct-to-patient message through the EHR portal with HCV antibody lab order.
MAIN OUTCOME AND MEASURE


The EHR was queried on a monthly basis for 6 months after the intervention to monitor which subjects completed HCV screening. For any subjects screened positive for HCV, follow-up through the cascade of HCV care was monitored, and if needed, scheduled by the study team.
KEY RESULTS


Of 1600 subjects, 538 (34%) completed HCV screening. In the stratum without an upcoming appointment, 18% in the control group completed screening compared to 26% in intervention group (p<0.01). Similarly, in the stratum with an upcoming appointment, 34% in the control group completed screening compared to 58% in the intervention group (p<0.01).
CONCLUSION


Direct-to-patient messaging coupled with automated lab orders improved HCV screening rates compared to standard of care, particularly in more engaged patients. Including this intervention in primary care can maximize screening with each visit, which is particularly valuable in times when physical throughput in the healthcare system may be low.",2022,"In the stratum without an upcoming appointment, 18% in the control group completed screening compared to 26% in intervention group (p<0.01).","['engaged patients, defined as those who have an upcoming visit scheduled, are more likely to respond to a direct-to-patient message with an automated lab order for hepatitis C virus (HCV) screening', 'Of 1600 subjects, 538 (34%) completed HCV screening', 'One thousand six hundred randomly selected Stanford Primary Care patients, 800 with an upcoming visit within 6 months and 800 without, born between 1945 and 1965 who were due for HCV screening', 'Primary Care']","['Electronic Patient Portal Messaging Increases Hepatitis C Virus Screening', 'direct-to-patient message through the EHR portal with HCV antibody lab order']",['HCV screening rates'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C4277550', 'cui_str': 'Patient Portal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",1600.0,0.0168353,"In the stratum without an upcoming appointment, 18% in the control group completed screening compared to 26% in intervention group (p<0.01).","[{'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Halket', 'Affiliation': 'Division of Primary Care and Population Health, Stanford University, Palo Alto, CA, USA. dhalket@stanford.edu.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Dang', 'Affiliation': 'Population Health, Stanford Hospital and Clinics, Palo Alto, CA, USA.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Phadke', 'Affiliation': 'Division of Primary Care and Population Health, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Channa', 'Initials': 'C', 'LastName': 'Jayasekera', 'Affiliation': 'Gastroenterology, Kaiser Permanente, Seattle, WA, USA.'}, {'ForeName': 'W Ray', 'Initials': 'WR', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology & Hepatology, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kwo', 'Affiliation': 'Division of Gastroenterology & Hepatology, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Downing', 'Affiliation': 'Department of Medicine, Center for Biomedical Informatics Research, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Goel', 'Affiliation': 'Division of Gastroenterology & Hepatology, Stanford University, Palo Alto, CA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-022-07460-1']
2911,35230621,Once-Weekly Semaglutide with Lifestyle Intervention Results in Clinically Significant Weight Loss.,,2022,,[],[],[],[],[],[],,0.0278392,,"[{'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Chang', 'Affiliation': 'Vanderbilt University School of Medicine, Vanderbilt University Medical Center, 2209 Garland Ave, Nashville, TN, 37232, USA. Rachel.s.chang@vanderbilt.edu.'}, {'ForeName': 'Jiun-Ruey', 'Initials': 'JR', 'LastName': 'Hu', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, 333 Cedar Street, New Haven, CT, 06520, USA.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Department of Medicine, Johns Hopkins University, 2024 E. Monument St., Suite 2-500, Baltimore, MD, 21205, USA.'}]",Journal of general internal medicine,['10.1007/s11606-021-07215-4']
2912,35233415,Evaluation of participatory learning approach for developing competency of human immunodeficiency virus risk assessment skills among MBBS undergraduate students.,"BACKGROUND


An Indian medical graduate needs to be competent in the diagnosis and management of human immunodeficiency virus (HIV) patients. This is crucial in terms of occupational safety. A participatory learning approach could be a possible way to change behavior and improve HIV risk assessment skills among medical students for better occupational safety and health care. The present study was planned to identify the need, provide different learning experiences for acquiring competency, and compare the effectiveness of participatory learning over traditional in developing HIV risk assessment skills.
MATERIALS AND METHODS


An educational interventional (randomized controlled trial) was carried out at GEMS and Hospital. Needs assessment survey was conducted, which identified HIV risk assessment as a key competency. For which the outcome-specific learning objectives were defined, two different learning experiences were employed. A pretest was conducted to assess the baseline knowledge and attitude ( n  = 92); they were then divided into two equal groups (A and B). ""A"" group was taught by participatory approach, whereas ""B"" by traditional techniques followed by posttest and objective structured clinical examination (OSCE) to assess their HIV risk assessment skills. Statistical analysis: Paired  t -test for assessing knowledge and attitude within the same group and unpaired  t -test for assessing skills between the two groups were used in this study.
RESULTS


Statistically significant improvement ( P  < 0.001) in knowledge and attitude scores was noticed that OSCE scores were significantly higher in the intervention group ""A"" ( P  < 0.001) as compared to ""B"" taught by traditional techniques.
CONCLUSION


Participatory learning effectively builds upon existing knowledge and attitude to develop better HIV risk assessment skills.",2021,"Statistically significant improvement ( P  < 0.001) in knowledge and attitude scores was noticed that OSCE scores were significantly higher in the intervention group ""A"" ( P  < 0.001) as compared to ""B"" taught by traditional techniques.
","['human immunodeficiency virus (HIV) patients', 'medical students', 'MBBS undergraduate students']","['participatory learning approach', 'participatory learning']","['OSCE scores', 'HIV risk assessment skills', 'knowledge and attitude scores']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0325126,"Statistically significant improvement ( P  < 0.001) in knowledge and attitude scores was noticed that OSCE scores were significantly higher in the intervention group ""A"" ( P  < 0.001) as compared to ""B"" taught by traditional techniques.
","[{'ForeName': 'Syed Irfan', 'Initials': 'SI', 'LastName': 'Ali', 'Affiliation': 'Department of Community Medicine, GEMS and Hospital, Srikakulam, Andhra Pradesh, India.'}, {'ForeName': 'Jarina', 'Initials': 'J', 'LastName': 'Begum', 'Affiliation': 'Department of Community Medicine, GEMS and Hospital, Srikakulam, Andhra Pradesh, India.'}, {'ForeName': 'D Lakshmi', 'Initials': 'DL', 'LastName': 'Lalitha', 'Affiliation': 'Department of Biochemistry, GEMS and Hospital, Srikakulam, Andhra Pradesh, India.'}, {'ForeName': 'M Ganesh', 'Initials': 'MG', 'LastName': 'Kamath', 'Affiliation': 'Department of Physiology, Melaka Manipal Medical College, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India.'}, {'ForeName': 'Rajesh Kumar', 'Initials': 'RK', 'LastName': 'Sethi', 'Affiliation': 'Department of Paediatrics, GEMS and Hospital, Srikakulam, Andhra Pradesh, India.'}, {'ForeName': 'Aruna Rani', 'Initials': 'AR', 'LastName': 'Behera', 'Affiliation': 'Department of Microbiology, GEMS and Hospital, Srikakulam, Andhra Pradesh, India.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_159_21']
2913,35233414,Comparison of the effect of two teaching methods on surgical technologist students' learning and satisfaction (flashcards vs. mobile-based learning).,"BACKGROUND


M-learning is ""learning across multiple contexts, through social and content interactions, using simple hand-held technologies, wireless and mobile network. This personal electronic device is a way to facilitate the transfer of learning and improve teaching. Hence, the researchers decided to design a mobile-based learning application to teach surgical instruments comprehensively and compare students' learning and satisfaction in both mobile-based learning and flashcards methods.
MATERIALS AND METHODS


An interventional study was conducted on surgical technologist students in Alborz University of medical science (2019). Students were divided into two groups: flashcards ( n  = 21) and mobile application learning group ( n  = 21). The difference of pre- and post-test scores was considered for the evaluation of learning level in two groups. Data were entered into SPSS 20.0 software and analyzed by statistics tests. Data were analyzed by a paired  t -test, independent  t -test, and Pearson's correlation coefficient.
RESULTS


There was no significant difference in students' knowledge level between two groups before intervention ( P  = 0.87) but there was significant difference between groups after the intervention ( P  = 0.003). In the evaluation of student's satisfaction, the mobile application was preferred by 84.28% of students.
CONCLUSION


Given the effectiveness of using both methods (flashcards and mobile application), it is recommended that these methods especially mobile application be used for surgical instruments education.",2021,There was no significant difference in students' knowledge level between two groups before intervention ( P  = 0.87) but there was significant difference between groups after the intervention ( P  = 0.003).,['surgical technologist students in Alborz University of medical science (2019'],['mobile application learning'],"[""students' knowledge level""]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0260280', 'cui_str': 'Technologist'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}]",,0.0422535,There was no significant difference in students' knowledge level between two groups before intervention ( P  = 0.87) but there was significant difference between groups after the intervention ( P  = 0.003).,"[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Sadati', 'Affiliation': 'Department of Operating Room, School of Allied Medical Sciences, Alborz University of Medical Science, Karaj, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Nafar', 'Affiliation': 'Department of Patient Safety, Master Degree in Nursing, Emamali Hospital, Alborz University of Medical Science, Karaj, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Karami', 'Affiliation': 'Ph.D Student of Medical Education, Medical Education Department, School of Medicine, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Mohamad Reza', 'Initials': 'MR', 'LastName': 'Yazdani', 'Affiliation': 'Surgical Technologist, Department of Operating Room, School of Allied Medical Sciences, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Zahra Nouri', 'Initials': 'ZN', 'LastName': 'Khaneghah', 'Affiliation': 'Ph.D. Student of Medical Education, Center For Educational Research In Medical Science (CERMS), Department of Medical Education, School of Medicine, Iran university of Medical Science, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_940_20']
2914,35233413,Investigating the effect of educational intervention based on the Pender's health promotion model on lifestyle and self-efficacy of the patients with diabetic foot ulcer: A clinical trial.,"BACKGROUND


This study aimed to investigate the effect of educational intervention based on the Pender's health promotion model (HPM) on lifestyle and self-efficacy of the patients with diabetic foot ulcer.
MATERIALS AND METHODS


In this clinical trial conducted in 2019, 74 patients based on inclusion criteria were selected through convenience sampling and allocated to two groups of intervention ( n  = 37) and control ( n  = 37) using the randomized permuted block method. In this study, Demographic characteristics and localized Diabetes Foot Care Self-Efficacy Scale and Health-Promoting Lifestyle Profile Questionnaire for diabetic foot care were completed by two groups. The obtained data were analyzed using SPSS 16 and through descriptive and comparative statistics, independent  t -test, paired  t -test, and ANCOVA.
RESULTS


After the intervention, the mean score of the intervention group significantly increased in all lifestyle dimensions ( P  < 0.001). Furthermore, the mean score of self-effcacy increased in the intervention group after the intervention ( P  < 0.001). Comparing the change in the mean scores of lifestyle and self-efficacy in both the groups 50 days after the intervention, an increase was observed in the mean scores of self-efficacy ( P  < 0.001) as well as those of lifestyle and its dimensions in the intervention group compared to those in the control group ( P  < 0.001).
CONCLUSION


Educational intervention based on the Pender's HPM can promote the self-efficacy, lifestyle, and its dimensions in the patients with diabetic foot ulcers. The results of this study can be used in educational interventions aiming at patients with diabetic foot ulcers to change their lifestyle and improve their self-efficacy.",2021,"After the intervention, the mean score of the intervention group significantly increased in all lifestyle dimensions ( P  < 0.001).","['patients with diabetic foot ulcer', 'patients with diabetic foot ulcers', '2019, 74 patients based on inclusion criteria were selected through convenience sampling and allocated to two groups of intervention ( n  = 37) and control ( n  = 37']","[""Pender's health promotion model (HPM"", 'educational intervention', 'Health-Promoting Lifestyle Profile Questionnaire']","['mean scores of lifestyle and self-efficacy', 'mean score of self-effcacy', 'mean scores of self-efficacy', 'mean score', 'lifestyle dimensions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",,0.0078596,"After the intervention, the mean score of the intervention group significantly increased in all lifestyle dimensions ( P  < 0.001).","[{'ForeName': 'Parya', 'Initials': 'P', 'LastName': 'Vakilian', 'Affiliation': 'Department of Medical Sergical Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mokhtar', 'Initials': 'M', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Medical Surgical Nursing, School of Nursing and Midwifery, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Oskouie', 'Affiliation': 'Department of Medical Surgical Nursing, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Asghar', 'Initials': 'AA', 'LastName': 'Firouzian', 'Affiliation': 'Department of Medical Surgical Nursing, School of Nursing and Midwifery, Esfarayen University of Medical Sciences, Esfarayen, Iran.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Khachian', 'Affiliation': 'Department of Medical Surgical Nursing, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_1301_20']
2915,35233395,Effect of media messages on health-promoting lifestyle of acute coronary syndrome patients: A randomized clinical trial.,"BACKGROUND


Patient education is a key factor in promoting the health of people with acute coronary syndrome (ACS), and the effective use of technology can play an important role in this regard. This study aimed to determine the effectiveness of education using media messages on the lifestyle of patients with ACS.
MATERIALS AND METHODS


The present clinical trial was conducted on 91 cases with ACS admitted to the cardiac ward of Afshar Hospital in Yazd, Iran, during 2018-2019, who were randomly assigned to control and intervention groups. The former only was provided with routine training before discharge, while the latter, in addition to routine training before discharge, received education on social networking and sending text/visual messages. At baseline and 3 months after the intervention, the Walker's Lifestyle Questionnaire was completed. The independent  t -test, paired  t -test, and Chi-square test were employed for data analysis.
RESULTS


The average lifestyle value of the intervention group was significantly higher compared with the control group after the intervention ( P  < 0.001). Moreover, the lifestyle score was significantly different pre- and post-intervention in the intervention group ( P  < 0.001).
CONCLUSIONS


Education using media messages is useful to promote the lifestyle in cases with ACS, which seems effective in planning the follow-up for these patients.",2021,The average lifestyle value of the intervention group was significantly higher compared with the control group after the intervention ( P  < 0.001).,"['people with acute coronary syndrome (ACS', 'patients with ACS', '91 cases with ACS admitted to the cardiac ward of Afshar Hospital in Yazd, Iran, during 2018-2019', 'acute coronary syndrome patients']",['media messages'],"['average lifestyle value', 'lifestyle score', 'health-promoting lifestyle']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",91.0,0.0179291,The average lifestyle value of the intervention group was significantly higher compared with the control group after the intervention ( P  < 0.001).,"[{'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Nouhi', 'Affiliation': 'Razi Faculty of Nursing and Midwifery, Department of Medical Surgical Nursing, Kerman University Of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Dahesh', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Shojaefar', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_1457_20']
2916,35233389,"Azithromycin for treatment of hospitalised COVID-19 patients: a randomised, multicentre, open-label clinical trial (DAWn-AZITHRO).","Background and objectives


Azithromycin was rapidly adopted as a repurposed drug to treat coronavirus disease 2019 (COVID-19) early in the pandemic. We aimed to evaluate its efficacy in patients hospitalised for COVID-19.
Methods


In a series of randomised, open-label, phase 2 proof-of-concept, multicentre clinical trials (Direct Antivirals Working against the novel coronavirus (DAWn)), several treatments were compared with standard of care. In 15 Belgian hospitals, patients hospitalised with moderate to severe COVID-19 were allocated 2:1 to receive standard of care plus azithromycin or standard of care alone. The primary outcome was time to live discharge or sustained clinical improvement, defined as a two-point improvement on the World Health Organization (WHO) ordinal scale sustained for at least 3 days.
Results


Patients were included between April 22 and December 17, 2020. When 15-day follow-up data were available for 160 patients (56% of preset cohort), an interim analysis was performed at request of the independent Data Safety and Monitoring Board. Subsequently, DAWn-AZITHRO was stopped for futility. In total, 121 patients were allocated to the treatment arm and 64 patients to the standard-of-care arm. We found no effect of azithromycin on the primary outcome with a hazard ratio of 1.044 (95% CI 0.772-1.413; p=0.7798). None of the predefined subgroups showed significant interaction as covariates in the Fine-Gray regression analysis. No benefit of azithromycin was found on any of the short- and longer-term secondary outcomes.
Conclusion


Time to clinical improvement is not influenced by azithromycin in patients hospitalised with moderate to severe COVID-19.",2022,We found no effect of azithromycin on the primary outcome with a hazard ratio of 1.044 (95% CI 0.772-1.413; p=0.7798).,"['patients hospitalised for COVID-19', 'Results\n\n\nPatients were included between April 22 and December 17, 2020', 'hospitalised COVID-19 patients', 'patients hospitalised with moderate to severe COVID-19', '15 Belgian hospitals, patients hospitalised with moderate to severe COVID-19', '121 patients were allocated to the treatment arm and 64 patients to the standard-of-care arm']","['standard of care plus azithromycin or standard of care alone', 'azithromycin', 'Azithromycin']","['time to live discharge or sustained clinical improvement, defined as a two-point improvement on the World Health Organization (WHO) ordinal scale sustained']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]",121.0,0.316844,We found no effect of azithromycin on the primary outcome with a hazard ratio of 1.044 (95% CI 0.772-1.413; p=0.7798).,"[{'ForeName': 'Iwein', 'Initials': 'I', 'LastName': 'Gyselinck', 'Affiliation': 'Dept of Respiratory Diseases, UZ Leuven and CHROMETA, Research group BREATHE, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Liesenborghs', 'Affiliation': 'Laboratory of Virology and Chemotherapy, Dept of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Belmans', 'Affiliation': 'Leuven Biostatistics and Statistical Bioinformatics Centre (L-BioStat), KU Leuven, Leuven and University Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Matthias M', 'Initials': 'MM', 'LastName': 'Engelen', 'Affiliation': 'Dept of Cardiovascular Diseases, UZ Leuven and Centre for Molecular and Vascular Biology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Betrains', 'Affiliation': 'Dept of General Internal Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Van Thillo', 'Affiliation': 'Center for Cancer Biology, Vlaams Instituut voor Biotechnologie (VIB), Leuven, Belgium.'}, {'ForeName': 'Pham Anh Hong', 'Initials': 'PAH', 'LastName': 'Nguyen', 'Affiliation': 'Dept of Respiratory Diseases, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Goeminne', 'Affiliation': 'Dept of Respiratory Diseases, AZ Nikolaas, Sint-Niklaas, Belgium.'}, {'ForeName': 'Ann-Catherine', 'Initials': 'AC', 'LastName': 'Soenen', 'Affiliation': 'Dept of Respiratory Diseases, Jan Yperman Ziekenhuis, Ypres, Belgium.'}, {'ForeName': 'Nikolaas', 'Initials': 'N', 'LastName': 'De Maeyer', 'Affiliation': 'Dept of Respiratory Diseases, Heilig Hart Ziekenhuis, Leuven, Belgium.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Pilette', 'Affiliation': 'Dept of Respiratory Diseases, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Papleux', 'Affiliation': 'Dept of Respiratory Diseases, Hôpitaux Iris Sud, Brussels, Belgium.'}, {'ForeName': 'Eef', 'Initials': 'E', 'LastName': 'Vanderhelst', 'Affiliation': 'Dept of Respiratory Diseases, University Hospital UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Derweduwen', 'Affiliation': 'Dept of Respiratory Diseases, AZ Klina, Brasschaat, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Alexander', 'Affiliation': 'Dept of Respiratory Diseases, AZ Glorieux, Ronse, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Bouckaert', 'Affiliation': 'Dept of Respiratory Diseases, AZ Delta, Roeselare, Belgium.'}, {'ForeName': 'Jean-Benoît', 'Initials': 'JB', 'LastName': 'Martinot', 'Affiliation': 'Dept of Respiratory Diseases, Centre Hospitalier Universitaire-UC Louvain, Namur, Belgium.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Decoster', 'Affiliation': 'Dept of Respiratory Diseases, AZ Turnhout, Turnhout, Belgium.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Vandeurzen', 'Affiliation': 'Dept of Respiratory Diseases, Mariaziekenhuis Noord Limburg, Pelt, Belgium.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Schildermans', 'Affiliation': 'Dept of Respiratory Diseases, AZ Sint Lucas, Bruges, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verhamme', 'Affiliation': 'Dept of Cardiovascular Diseases, UZ Leuven and Centre for Molecular and Vascular Biology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Janssens', 'Affiliation': 'Dept of Respiratory Diseases, UZ Leuven and CHROMETA, Research group BREATHE, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Vos', 'Affiliation': 'Dept of Respiratory Diseases, UZ Leuven and CHROMETA, Research group BREATHE, KU Leuven, Leuven, Belgium.'}]",ERJ open research,['10.1183/23120541.00610-2021']
2917,35233694,Efficacy of a 0.05% cyclosporine a topical nanoemulsion in dry eyes with obstructive meibomian gland dysfunction.,"PURPOSE


To evaluate the efficacy of topical cyclosporin A (CsA) in obstructive meibomian gland dysfunction (MGD).
STUDY DESIGN


Prospective, randomized, single-blinded, controlled clinical study.
METHODS


Fifty-one patients with obstructive MGD were randomly assigned to one of two groups. The CsA group received 0.05% CsA topical nanoemulsion (Cyporin N®; Taejoon Pharm) twice daily, 0.15% hyaluronic acid eye drops four times daily, and 10 min of warm compress placement on the eyelids twice daily. In the control group, 0.15% hyaluronic acid eye drops were administered six times daily and warm compress was conducted twice daily for 10 min. The ocular surface disease index (OSDI), Schirmer 1 test, tear film break-up time (TBUT), corneal and conjunctival surface staining using fluorescein, eyelid debris and eyelid redness/swelling, upper and lower meibomian gland (MG) secretion scores, and upper and lower MG loss were assessed at the three-month visits.
RESULTS


There were no significant differences in observed parameters between the two groups at baseline. At the three-month evaluation, the CsA group showed significantly better improvements in the TBUT, eyelid debris, eyelid redness/swelling, and lower MG secretion score (P < 0.001, P < 0.001, P < 0.001, and P < 0.001, respectively). There was no improvement in upper or lower MG loss in either group.
CONCLUSION


Treatment with 0.05% CsA nanoemulsion in combination with warm compress twice daily alleviated signs of dry eyes with obstructive MGD. However, although MG secretion was improved, glandular loss could not be restored with three months of CsA nanoemulsion treatment.",2022,"At the three-month evaluation, the CsA group showed significantly better improvements in the TBUT, eyelid debris, eyelid redness/swelling, and lower MG secretion score (P < 0.001, P < 0.001, P < 0.001, and P < 0.001, respectively).","['dry eyes with obstructive meibomian gland dysfunction', 'Fifty-one patients with obstructive MGD', 'obstructive meibomian gland dysfunction (MGD']","['CsA topical nanoemulsion (Cyporin N®; Taejoon Pharm) twice daily, 0.15% hyaluronic acid', 'cyclosporine', 'hyaluronic acid', 'topical cyclosporin A (CsA']","['TBUT, eyelid debris, eyelid redness/swelling, and lower MG secretion score', 'ocular surface disease index (OSDI), Schirmer 1 test, tear film break-up time (TBUT), corneal and conjunctival surface staining using fluorescein, eyelid debris and eyelid redness/swelling, upper and lower meibomian gland (MG) secretion scores, and upper and lower MG loss', 'glandular loss']","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}]","[{'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0858967', 'cui_str': 'Redness of eyelid'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0449895', 'cui_str': 'Stain used'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0225353', 'cui_str': 'Glandular'}]",51.0,0.0591355,"At the three-month evaluation, the CsA group showed significantly better improvements in the TBUT, eyelid debris, eyelid redness/swelling, and lower MG secretion score (P < 0.001, P < 0.001, P < 0.001, and P < 0.001, respectively).","[{'ForeName': 'Jay Won', 'Initials': 'JW', 'LastName': 'Rhim', 'Affiliation': 'Miso Eye Clinic, Seoul, Republic of Korea.'}, {'ForeName': 'Youngsub', 'Initials': 'Y', 'LastName': 'Eom', 'Affiliation': 'Department of Ophthalmology, Korea University Ansan Hospital, 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15355, Republic of Korea. hippotate@hanmail.net.'}, {'ForeName': 'Eun Gyu', 'Initials': 'EG', 'LastName': 'Yoon', 'Affiliation': 'Department of Ophthalmology, Korea University Ansan Hospital, 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15355, Republic of Korea.'}, {'ForeName': 'Seo Yeon', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, Korea University Ansan Hospital, 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15355, Republic of Korea.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Department of Ophthalmology, Korea University Ansan Hospital, 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15355, Republic of Korea.'}, {'ForeName': 'Jong Suk', 'Initials': 'JS', 'LastName': 'Song', 'Affiliation': 'Department of Ophthalmology, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo Myung', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Korea University College of Medicine, Seoul, Republic of Korea.'}]",Japanese journal of ophthalmology,['10.1007/s10384-022-00906-3']
2918,35233617,"Effect of remdesivir on viral dynamics in COVID-19 hospitalized patients: a modelling analysis of the randomized, controlled, open-label DisCoVeRy trial.","BACKGROUND


The antiviral efficacy of remdesivir in COVID-19 hospitalized patients remains controversial.
OBJECTIVES


To estimate the effect of remdesivir in blocking viral replication.
METHODS


We analysed nasopharyngeal normalized viral loads from 665 hospitalized patients included in the DisCoVeRy trial (NCT04315948; EudraCT 2020-000936-23), randomized to either standard of care (SoC) or SoC + remdesivir. We used a mathematical model to reconstruct viral kinetic profiles and estimate the antiviral efficacy of remdesivir in blocking viral replication. Additional analyses were conducted stratified on time of treatment initiation (≤7 or >7 days since symptom onset) or viral load at randomization (< or ≥3.5 log10 copies/104 cells).
RESULTS


In our model, remdesivir reduced viral production by infected cells by 2-fold on average (95% CI: 1.5-3.2-fold). Model-based simulations predict that remdesivir reduced time to viral clearance by 0.7 days compared with SoC, with large inter-individual variabilities (IQR: 0.0-1.3 days). Remdesivir had a larger impact in patients with high viral load at randomization, reducing viral production by 5-fold on average (95% CI: 2.8-25-fold) and the median time to viral clearance by 2.4 days (IQR: 0.9-4.5 days).
CONCLUSIONS


Remdesivir halved viral production, leading to a median reduction of 0.7 days in the time to viral clearance compared with SoC. The efficacy was larger in patients with high viral load at randomization.",2022,"Model-based simulations predict that remdesivir reduced time to viral clearance by 0.7 days compared with SoC, with large inter-individual variabilities (IQR: 0.0-1.3 days).","['COVID-19 hospitalized patients', '665 hospitalized patients included in the DisCoVeRy trial (NCT04315948; EudraCT 2020-000936-23', 'patients with high viral load at randomization']","['standard of care (SoC) or SoC\u200a+\u200aremdesivir', 'remdesivir']","['viral dynamics', 'viral clearance', 'viral production', 'median time to viral clearance']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517848', 'cui_str': '665'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",665.0,0.17469,"Model-based simulations predict that remdesivir reduced time to viral clearance by 0.7 days compared with SoC, with large inter-individual variabilities (IQR: 0.0-1.3 days).","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lingas', 'Affiliation': 'Université de Paris, IAME, INSERM, F-75018 Paris, France.'}, {'ForeName': 'Nadège', 'Initials': 'N', 'LastName': 'Néant', 'Affiliation': 'Université de Paris, IAME, INSERM, F-75018 Paris, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gaymard', 'Affiliation': 'Hospices Civils de Lyon, Département de Virologie, Institut des Agents Infectieux, Centre National de Référence des virus des infections respiratoires France Sud, F-69004, Lyon, France.'}, {'ForeName': 'Drifa', 'Initials': 'D', 'LastName': 'Belhadi', 'Affiliation': 'Université de Paris, IAME, INSERM, F-75018 Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Peytavin', 'Affiliation': 'Université de Paris, IAME, INSERM, F-75018 Paris, France.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Hites', 'Affiliation': 'Hôpital Universitaire de Bruxelles-Hôpital Erasme, Université Libre de Bruxelles, Clinique des maladies infectieuses, Brussels, Belgium.'}, {'ForeName': 'Thérèse', 'Initials': 'T', 'LastName': 'Staub', 'Affiliation': 'Centre hospitalier de Luxembourg, Service des maladies infectieuses, L-1210 Luxembourg, Luxembourg.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III with Haematology, Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Oncologic Center, Salzburg Cancer Research Institute - Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Paracelsus Medical University Salzburg, 5020 Salzburg, Austria.'}, {'ForeName': 'Jose-Artur', 'Initials': 'JA', 'LastName': 'Paiva', 'Affiliation': 'Centro Hospitalar São João, Emergency and Intensive Care Department, Porto, Portugal.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Poissy', 'Affiliation': 'Université de Lille, Inserm U1285, CHU Lille, Pôle de réanimation, CNRS, UMR 8576 - UGSF - Unité de Glycobiologie Structurale et Fonctionnelle, F-59000, Lille, France.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Peiffer-Smadja', 'Affiliation': 'Université de Paris, IAME, INSERM, F-75018 Paris, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Costagliola', 'Affiliation': ""Sorbonne Université, Inserm, Institut Pierre-Louis d'Épidémiologie et de Santé Publique, F-75013, Paris, France.""}, {'ForeName': 'Yazdan', 'Initials': 'Y', 'LastName': 'Yazdanpanah', 'Affiliation': 'Université de Paris, IAME, INSERM, F-75018 Paris, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Wallet', 'Affiliation': 'Service de Médecine Intensive Réanimation anesthésie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre-Benite, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Gagneux-Brunon', 'Affiliation': ""CHU de Saint-Etienne, Service d'Infectiologie, F-42055 Saint-Etienne, France.""}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Mentré', 'Affiliation': 'Université de Paris, IAME, INSERM, F-75018 Paris, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Ader', 'Affiliation': 'Université Claude Bernard Lyon 1, CIRI, INSERM U1111, CNRS UMR5308, ENS Lyon, F-69372, Lyon, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Burdet', 'Affiliation': 'Université de Paris, IAME, INSERM, F-75018 Paris, France.'}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Guedj', 'Affiliation': 'Université de Paris, IAME, INSERM, F-75018 Paris, France.'}, {'ForeName': 'Maude', 'Initials': 'M', 'LastName': 'Bouscambert-Duchamp', 'Affiliation': 'Hospices Civils de Lyon, Département de Virologie, Institut des Agents Infectieux, Centre National de Référence des virus des infections respiratoires France Sud, F-69004, Lyon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkac048']
2919,35234006,Scarification and Seed Biomatriconditioning Effect Using Endophytic-Rhizobacteria in Areca Nut ( Areca catechu  L.) Seedling Vigor.,"&lt;b&gt;Background and Objective:&lt;/b&gt; Intensive and commercial development of areca nut requires the provision of high-vigour areca nut. This study aimed to evaluate the effect of scarification and seeds biomatriconditioning using endophytic-rhizobacteria in increasing seedlings vigor of areca nut. &lt;b&gt;Materials and Methods:&lt;/b&gt; The research was carried out at the Agronomy Unit of Agrotechnology Laboratory, Agriculture Faculty, Halu Oleo University, from November, 2020-March, 2021. The research design was split-plot in a Completely Randomized Design (CRD). The main plot, seed scarification, consisted of 2 treatments, without scarification and scarification. Sub-plots, seeds biomatriconditioning using endophytic-rhizobacteria, consisted of 6 treatments, control, L1-R, M5-R, LA6-R, LA2-E and RJ6-R. &lt;b&gt;Results:&lt;/b&gt; The results showed that the scarification treatment did not affect the seedlings vigor of the areca nut. Seed biomatriconditioning using endophytic-rhizobacteria was able to increase seedling vigor both without scarification and with scarification. There were 3 isolates of endophytic-rhizobacteria which were more able to increase the vigor of areca nut without scarification, namely L1-R, LA6-R and LA2-E, with an increase of 137, 104 and 102%, respectively compared to the control, while in scarified seeds, L1-R isolate was able to increase the seedlings vigor of areca nut by 194% compared to the control. &lt;b&gt;Conclusion:&lt;/b&gt; Scarification treatment did not affect the vigor of the areca nut. Seed biomatriconditioning with endophytic-rhizobacteria was able to increase the vigor of areca nut seeds either without scarification or with scarification.",2022,Seed biomatriconditioning using endophytic-rhizobacteria was able to increase seedling vigor both without scarification and with scarification.,['Areca Nut ( Areca catechu  L'],[],"['seedlings vigor of the areca nut', 'seedlings vigor of areca nut', 'vigor of the areca nut', 'vigor of areca nut without scarification, namely L1-R, LA6-R and LA2-E']","[{'cui': 'C0331487', 'cui_str': 'Areca catechu'}]",[],"[{'cui': 'C0242437', 'cui_str': 'Seedling'}, {'cui': 'C0331487', 'cui_str': 'Areca catechu'}, {'cui': 'C0184907', 'cui_str': 'Scarification'}]",,0.0462416,Seed biomatriconditioning using endophytic-rhizobacteria was able to increase seedling vigor both without scarification and with scarification.,"[{'ForeName': 'Gusti', 'Initials': 'G', 'LastName': 'Ayu Kade Sutariati', 'Affiliation': ''}, {'ForeName': 'Nini', 'Initials': 'N', 'LastName': 'Mila Rahni', 'Affiliation': ''}, {'ForeName': 'Tresjia', 'Initials': 'T', 'LastName': 'Corina Rakian', 'Affiliation': ''}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Madiki', 'Affiliation': ''}, {'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'Risqi Maharani', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Muhidin', 'Affiliation': ''}, {'ForeName': 'La', 'Initials': '', 'LastName': 'Mudi', 'Affiliation': ''}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Nurhayati Yusuf', 'Affiliation': ''}, {'ForeName': 'Gusti', 'Initials': 'G', 'LastName': 'Ngurah Adhi Wibawa', 'Affiliation': ''}]",Pakistan journal of biological sciences : PJBS,['10.3923/pjbs.2022.168.174']
2920,35233984,Pharmacological hypogonadism impairs molecular transducers of exercise-induced muscle growth in humans.,"BACKGROUND


The relative role of skeletal muscle mechano-transduction in comparison with systemic hormones, such as testosterone (T), in regulating hypertrophic responses to exercise is contentious. We investigated the mechanistic effects of chemical endogenous T depletion adjuvant to 6 weeks of resistance exercise training (RET) on muscle mass, function, myogenic regulatory factors, and muscle anabolic signalling in younger men.
METHODS


Non-hypogonadal men (n = 16; 18-30 years) were randomized in a double-blinded fashion to receive placebo (P, saline n = 8) or the GnRH analogue, Goserelin [Zoladex (Z), 3.6 mg, n = 8], injections, before 6 weeks of supervised whole-body RET. Participants underwent dual-energy X-ray absorptiometry (DXA), ultrasound of m. vastus lateralis (VL), and VL biopsies for assessment of cumulative muscle protein synthesis (MPS), myogenic gene expression, and anabolic signalling pathway responses.
RESULTS


Zoladex suppressed endogenous T to within the hypogonadal range and was well tolerated; suppression was associated with blunted fat free mass [Z: 55.4 ± 2.8 to 55.8 ± 3.1 kg, P = 0.61 vs. P: 55.9 ± 1.7 to 57.4 ± 1.7 kg, P = 0.006, effect size (ES) = 0.31], composite strength (Z: 40 ± 2.3% vs. P: 49.8 ± 3.3%, P = 0.03, ES = 1.4), and muscle thickness (Z: 2.7 ± 0.4 to 2.69 ± 0.36 cm, P > 0.99 vs. P: 2.74 ± 0.32 to 2.91 ± 0.32 cm, P < 0.0001, ES = 0.48) gains. Hypogonadism attenuated molecular transducers of muscle growth related to T metabolism (e.g. androgen receptor: Z: 1.2 fold, P > 0.99 vs. P: 1.9 fold, P < 0.0001, ES = 0.85), anabolism/myogenesis (e.g. IGF-1Ea: Z: 1.9 fold, P = 0.5 vs. P: 3.3 fold, P = 0.0005, ES = 0.72; IGF-1Ec: Z: 2 fold, P > 0.99 vs. P: 4.7 fold, P = 0.0005, ES = 0.68; myogenin: Z: 1.3 fold, P > 0.99 vs. P: 2.7 fold, P = 0.002, ES = 0.72), RNA/DNA (Z: 0.47 ± 0.03 to 0.53 ± 0.03, P = 0.31 vs. P: 0.50 ± 0.01 to 0.64 ± 0.04, P = 0.003, ES = 0.72), and RNA/ASP (Z: 5.8 ± 0.4 to 6.8 ± 0.5, P > 0.99 vs. P: 6.5 ± 0.2 to 8.9 ± 1.1, P = 0.008, ES = 0.63) ratios, as well as acute RET-induced phosphorylation of growth signalling proteins (e.g. AKT ser473  : Z: 2.74 ± 0.6, P = 0.2 vs. P: 5.5 ± 1.1 fold change, P < 0.001, ES = 0.54 and mTORC1 ser2448  : Z: 1.9 ± 0.8, P > 0.99 vs. P: 3.6 ± 1 fold change, P = 0.002, ES = 0.53). Both MPS (Z: 1.45 ± 0.11 to 1.50 ± 0.06%·day -1  , P = 0.99 vs. P: 1.5 ± 0.12 to 2.0 ± 0.15%·day -1  , P = 0.01, ES = 0.97) and (extrapolated) muscle protein breakdown (Z: 93.16 ± 7.8 vs. P: 129.1 ± 13.8 g·day -1  , P = 0.04, ES = 0.92) were reduced with hypogonadism result in lower net protein turnover (3.9 ± 1.1 vs. 1.2 ± 1.1 g·day -1  , P = 0.04, ES = 0.95).
CONCLUSIONS


We conclude that endogenous T sufficiency has a central role in the up-regulation of molecular transducers of RET-induced muscle hypertrophy in humans that cannot be overcome by muscle mechano-transduction alone.",2022,"Both MPS (Z: 1.45 ± 0.11 to 1.50 ± 0.06%·day -1  , P = 0.99 vs. P: 1.5 ± 0.12 to 2.0 ± 0.15%·day -1  , P = 0.01, ES = 0.97) and (extrapolated) muscle protein breakdown (Z: 93.16 ± 7.8 vs. P: 129.1 ± 13.8 g·day -1  , P = 0.04, ES = 0.92) were reduced with hypogonadism result in lower net protein turnover (3.9 ± 1.1 vs. 1.2 ± 1.1 ","['younger men', 'Non-hypogonadal men (n\xa0', '16; 18-30\xa0years', 'humans']","['chemical endogenous T depletion adjuvant to 6\xa0weeks of resistance exercise training (RET', 'dual-energy X-ray absorptiometry (DXA), ultrasound of m. vastus lateralis (VL), and VL biopsies', 'placebo (P, saline n\xa0=\xa08) or the GnRH analogue, Goserelin [Zoladex (Z), 3.6\xa0mg, n\xa0=\xa08], injections, before 6\xa0weeks of supervised whole-body RET']","['tolerated; suppression', 'g·day -1  , P\xa0', 'muscle mass, function, myogenic regulatory factors, and muscle anabolic signalling', 'composite strength', 'cumulative muscle protein synthesis (MPS), myogenic gene expression, and anabolic signalling pathway responses', 'muscle thickness', 'anabolism/myogenesis']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0224444', 'cui_str': 'Structure of vastus lateralis muscle'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C0149473', 'cui_str': 'Zoladex'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0206474', 'cui_str': 'Myogenic Regulatory Factors'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0002845', 'cui_str': 'Anabolic steroid'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0005572', 'cui_str': 'bioformation'}, {'cui': 'C0596997', 'cui_str': 'Myogenesis'}]",,0.11755,"Both MPS (Z: 1.45 ± 0.11 to 1.50 ± 0.06%·day -1  , P = 0.99 vs. P: 1.5 ± 0.12 to 2.0 ± 0.15%·day -1  , P = 0.01, ES = 0.97) and (extrapolated) muscle protein breakdown (Z: 93.16 ± 7.8 vs. P: 129.1 ± 13.8 g·day -1  , P = 0.04, ES = 0.92) were reduced with hypogonadism result in lower net protein turnover (3.9 ± 1.1 vs. 1.2 ± 1.1 ","[{'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Gharahdaghi', 'Affiliation': 'MRC-Verus Arthritis Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Supreeth', 'Initials': 'S', 'LastName': 'Rudrappa', 'Affiliation': 'MRC-Verus Arthritis Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Brook', 'Affiliation': 'MRC-Verus Arthritis Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Wesam', 'Initials': 'W', 'LastName': 'Farrash', 'Affiliation': 'MRC-Verus Arthritis Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Iskandar', 'Initials': 'I', 'LastName': 'Idris', 'Affiliation': 'MRC-Verus Arthritis Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Muhammad Hariz Abdul', 'Initials': 'MHA', 'LastName': 'Aziz', 'Affiliation': 'MRC-Verus Arthritis Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Fawzi', 'Initials': 'F', 'LastName': 'Kadi', 'Affiliation': 'Division of Sports Sciences, School of Health and Medical Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Papaioannou', 'Affiliation': 'Division of Sports Sciences, School of Health and Medical Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Bethan E', 'Initials': 'BE', 'LastName': 'Phillips', 'Affiliation': 'MRC-Verus Arthritis Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Tanvir', 'Initials': 'T', 'LastName': 'Sian', 'Affiliation': 'MRC-Verus Arthritis Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Herrod', 'Affiliation': 'MRC-Verus Arthritis Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Wilkinson', 'Affiliation': 'MRC-Verus Arthritis Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Nathaniel J', 'Initials': 'NJ', 'LastName': 'Szewczyk', 'Affiliation': 'MRC-Verus Arthritis Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'MRC-Verus Arthritis Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'MRC-Verus Arthritis Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12843']
2921,35233974,Default mode network connectivity and treatment response in geriatric depression.,"OBJECTIVES


Default mode network (DMN) connectivity is altered in depression. We evaluated the relationship between changes in within-network DMN connectivity and improvement in depression in a subsample of our parent clinical trial comparing escitalopram/memantine (ESC/MEM) to escitalopram/placebo (ESC/PBO) in older depressed adults (NCT01902004).
METHODS


Twenty-six participants with major depression (age > 60 years) and subjective memory complaints underwent treatment with ESC/MEM (n = 13) or ESC/PBO (n = 13), and completed baseline and 3-month follow-up resting state magnetic resonance imaging scans. Multi-block partial least squares correlation analysis was used to evaluate the impact of treatment on within-network DMN connectivity changes and their relationship with symptom improvement at 3 months (controlling for age and sex).
RESULTS


A significant latent variable was identified, reflecting within-network DMN connectivity changes correlated with symptom improvement (p = .01). Specifically, although overall group differences in within-network DMN connectivity changes failed to reach significance, increased within-network connectivity of posterior/lateral DMN regions (precuneus, angular gyrus, superior/middle temporal cortex) was more strongly and positively correlated with symptom improvement in the ESC/MEM group (r = 0.97, 95% confidence interval: 0.86-0.98) than in the ESC/PBO group (r = 0.36, 95% confidence interval: 0.13-0.72).
CONCLUSIONS


Increased within-network connectivity of core DMN nodes was more strongly correlated with depressive symptom improvement with ESC/MEM than with ESC/PBO, supporting an improved engagement of brain circuitry implicated in the amelioration of depressive symptoms with combined ESC/MEM treatment in older adults with depression and subjective memory complaints.",2022,"Increased within-network connectivity of core DMN nodes was more strongly correlated with depressive symptom improvement with ESC/MEM than with ESC/PBO, supporting an improved engagement of brain circuitry implicated in the amelioration of depressive symptoms with combined ESC/MEM treatment in older adults with depression and subjective memory complaints.","['older depressed adults (NCT01902004', 'geriatric depression', 'Twenty-six participants with major depression (age\xa0>\xa060 years) and subjective memory complaints underwent treatment with', 'older adults with depression and subjective memory complaints', 'n\xa0=\xa013) or']","['escitalopram/memantine (ESC/MEM', 'ESC/MEM', 'placebo (ESC/PBO', 'ESC/PBO (n\xa0=\xa013), and completed baseline and 3-month follow-up resting state magnetic resonance imaging scans']","['network connectivity of posterior/lateral DMN regions (precuneus, angular gyrus, superior/middle temporal cortex']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0152305', 'cui_str': 'Structure of angular gyrus'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}]",26.0,0.126344,"Increased within-network connectivity of core DMN nodes was more strongly correlated with depressive symptom improvement with ESC/MEM than with ESC/PBO, supporting an improved engagement of brain circuitry implicated in the amelioration of depressive symptoms with combined ESC/MEM treatment in older adults with depression and subjective memory complaints.","[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kilpatrick', 'Affiliation': 'G. Oppenheimer Family Center for Neurobiology of Stress and Resilience, Vatche and Tamar Manoukian Division of Digestive Diseases, David Geffen School of Medicine at University of California, Los Angeles, California, USA.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Krause-Sorio', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Prabha', 'Initials': 'P', 'LastName': 'Siddarth', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Narr', 'Affiliation': 'Brain Mapping Center, Departments of Neurology, and Psychiatry and Biobehavioral Sciences, Los Angeles, California, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lavretsky', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, California, USA.'}]",Brain and behavior,['10.1002/brb3.2475']
2922,35234160,Short-term effects of lumbopelvic complex stability training in elite female road cyclists.,"OBJECTIVES


The purpose of this study was to determine the effects of short-term lumbopelvic stability training on muscular endurance and stability in elite female cyclists.
METHODS


Twenty-four female road cyclists were randomly allocated to a core training group (CTG, n=12) or control group (CG, n=12). In addition to their scheduled training the CTG performed a core training program, that consisted of 6 core exercises performed in a session every other day until a total of 8 training sessions were completed. The CG did not receive the core training program and completed their scheduled training. The lumbopelvic-hip complex was assessed pre- and post-core program included the following exercises: single leg deadlift (SLD), bird-dog (BD), plank test (PT), and side-bridge plank test (SPT).
RESULTS


In comparison to CG, CTG significantly improved the time to failure in PT, SPT-Left, and SPT-Right ( p <0.05). Further, CTG resulted in a significant decrease in SLD ( p <0.05) compared to CG for the three accelerometry measures.
CONCLUSION


The present results indicate that following 8 sessions of lumbopelvic stability training muscular endurance and core stability were enhanced.",2022,"In comparison to CG, CTG significantly improved the time to failure in PT, SPT-Left, and SPT-Right ( p <0.05).","['elite female cyclists', 'Twenty-four female road cyclists', 'elite female road cyclists']","['exercises: single leg deadlift (SLD), bird-dog (BD), plank test (PT), and side-bridge plank test (SPT', 'short-term lumbopelvic stability training', 'CTG', 'lumbopelvic complex stability training', 'core training group (CTG']","['time to failure in PT, SPT-Left, and SPT-Right', 'muscular endurance and stability', 'SLD']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0442650', 'cui_str': 'Road'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0005595', 'cui_str': 'Class Aves'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",24.0,0.00384799,"In comparison to CG, CTG significantly improved the time to failure in PT, SPT-Left, and SPT-Right ( p <0.05).","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'San Emeterio', 'Affiliation': 'Laboratory of Physiology, European University Miguel de Cervantes, Spain.'}, {'ForeName': 'Darryl', 'Initials': 'D', 'LastName': 'Cochrane', 'Affiliation': 'School of Sport, Exercise & Nutrition, Massey University, New Zealand.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Guillén-Rogel', 'Affiliation': 'Laboratory of Physiology, European University Miguel de Cervantes, Spain.'}, {'ForeName': 'Pedro J', 'Initials': 'PJ', 'LastName': 'Marín', 'Affiliation': 'CYMO Research Institute, Spain.'}]",Journal of musculoskeletal & neuronal interactions,[]
2923,35234153,"What are the efficacy and safety of pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D? - A Cochrane Review summary with commentary.",,2022,,['people with chronic kidney disease stages 3-5D'],['placebo'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0282268,,"[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Iolascon', 'Affiliation': 'Department of Medical and Surgical Specialties and Dentistry, University of Campania ""Luigi Vanvitelli"", Italy.'}, {'ForeName': 'Antimo', 'Initials': 'A', 'LastName': 'Moretti', 'Affiliation': 'Department of Medical and Surgical Specialties and Dentistry, University of Campania ""Luigi Vanvitelli"", Italy.'}]",Journal of musculoskeletal & neuronal interactions,[]
2924,35234097,Preliminary bronchodilator dose effect on aerosol-delivery through different nebulizers in noninvasively ventilated COPD patients.,"Objectives:  This study aimed to evaluate the effect of a preliminary bronchodilator dose on the aerosol-d elivery by different nebulizers in noninvasively ventilated chronic obstructive pulmonary disease (COPD) patients.  Method:  COPD patients were randomized to receive study doses of 800 µg beclomethasone dipropionate (BPD) nebulized by either a vibrating mesh nebulizer (VMN) or a jet nebulizer (JN) connected to MinimHal spacer device. On a different day, the nebulized dose of beclomethasone was given to each patient by the same aerosol generator with and without preceded two puffs (100 µg each) of salbutamol delivered by a pressurized-metered dose inhaler. Urinary BPD and its metabolites in 30 min post-inhalation samples and pooled up to 24 h post-inhalation were measured. On day 2, ex-vivo studies were performed with BPD collected on filters before reaching patients which were eluted from filters and analyzed to estimate the total emitted dose. Results:  The highest urinary excretion amounts of BPD and its metabolites 30 min and 24 h post-inhalation were identified with pMDI + VMN compared with other regimens( p  < 0.001). The amounts of BPD and its metabolites excreted 30 min post inhalation had approximately doubled with pMDI + JN compared with JN delivery ( p  < 0.05). No significant effect was found in the ex-vivo study results except between VMN and JN with a significant superiority of the VMN ( p  < 0.001). Conclusion:  Using a preliminary bronchodilator dose before drug nebulization significantly increased the effective lung dose of the nebulized drug with both VMNs and JNs. However, adding a preliminary bronchodilator dose increased the 24 hr cumulative urinary amount of the drug representing higher systemic delivery of the drug, which in turn could result in higher systemic side effects.",2022,No significant effect was found in the ex-vivo study results except between VMN and JN with a significant superiority of the VMN ( p  < 0.001).,"['Method:  COPD patients', 'noninvasively ventilated COPD patients', 'noninvasively ventilated chronic obstructive pulmonary disease (COPD) patients']","['salbutamol', 'beclomethasone', 'aerosol-d elivery by different nebulizers', 'beclomethasone dipropionate (BPD) nebulized by either a vibrating mesh nebulizer (VMN) or a jet nebulizer (JN) connected to MinimHal spacer device']","['effective lung dose', 'Urinary BPD and its metabolites', 'highest urinary excretion amounts of BPD and its metabolites 30\u2009min and 24\u2009h post-inhalation']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}]","[{'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0004905', 'cui_str': 'Beclomethasone'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0027524', 'cui_str': 'Nebulizer'}, {'cui': 'C0004906', 'cui_str': 'Beclomethasone dipropionate'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]",,0.0750938,No significant effect was found in the ex-vivo study results except between VMN and JN with a significant superiority of the VMN ( p  < 0.001).,"[{'ForeName': 'Yasmin M', 'Initials': 'YM', 'LastName': 'Madney', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-suef, Egypt.'}, {'ForeName': 'Hadeer S', 'Initials': 'HS', 'LastName': 'Harb', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-suef, Egypt.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Porée', 'Affiliation': 'ProtecSom-OptimHal, Valognes, France.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Eckes', 'Affiliation': 'ProtecSom-OptimHal, Valognes, France.'}, {'ForeName': 'Marina E', 'Initials': 'ME', 'LastName': 'Boules', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-suef, Egypt.'}, {'ForeName': 'Mohamed E A', 'Initials': 'MEA', 'LastName': 'Abdelrahim', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-suef, Egypt.'}]",Experimental lung research,['10.1080/01902148.2022.2047243']
2925,35234092,Switching to a NRTI-free 2 drug regimen (2DR) -a sub-analysis of the 48 weeks DUALIS study on metabolic and renal changes.,"Background/Aims:  Switching from a three-drug regimen (3DR: boosted darunavir [bDRV] and two nucleoside reverse transcriptase inhibitors [NRTIs]) to a two-drug regimen (2DR: bDRV and dolutegravir [DTG]) demonstrated non-inferiority with regard to viral suppression in people living with HIV (PLWH) in the DUALIS study. This sub-analysis focuses on changes in metabolic and renal parameters when sparing the NRTI backbone. Methods:  DUALIS was a randomized, open-label, multicenter (27) phase 3-trial. Participants were virologically suppressed (HIV-RNA < 50 copies/mL) on 3DR for at least 24 weeks. Subjects were either switched to DTG 50 mg + bDRV 800 mg (with ritonavir 100 mg) (2DR) or continued their regimen consisting of two NRTIs in combination with ritonavir-bDRV (3DR) once daily. Data of metabolic and renal parameters at baseline and week 48 were compared. Results:  The LDL-fraction increased by + 13.3 (-3.0 to +31.3) mg/dL on 2DRs and was stable (-14.0 to +18.0 mg/dL) on 3DRs ( p  < 0.0010).PLWH gained +2.0 (-0.2 to +4.0) kg and +0.2 (-1.9 to +2.1) kg in body weight on 2DRs and 3DRs, respectively 3 ( p  = 0.0006).The MDRD eGFR decreased by -7,8 (-17.4 to -0.3) mL/min/1.73m 2  and 0.4 (-8.8 to +5.7) mL/min/1.73m 2  on 2DRs and 3DRs, respectively ( p  = 0.0002), while serum levels of cystatin C were stable in both arms (2DR: -0.1 to +0.1 mg/L; 3DR: 0.0 to +0.1 mg/L). Conclusions:  While being non-inferior in terms of viral suppression, sparing the NRTI backbone showed a non-favorable profile in metabolic or renal parameters over 48 weeks.",2022,"mL/min/1.73m 2  on 2DRs and 3DRs, respectively ( p  = 0.0002), while serum levels of cystatin C were stable in both arms","['2DR', 'people living with HIV (PLWH']","['three-drug regimen (3DR: boosted darunavir', 'drug regimen (2DR: bDRV and dolutegravir [DTG', 'NRTI-free 2 drug regimen (2DR) -a', 'nucleoside reverse transcriptase inhibitors [NRTIs', 'DTG 50\u2009mg\u2009+\u2009bDRV 800\u2009mg (with ritonavir 100\u2009mg) (2DR) or continued their regimen consisting of two NRTIs in combination with ritonavir-bDRV (3DR']","['MDRD eGFR', 'LDL-fraction', 'serum levels of cystatin C', 'metabolic and renal changes', '3DRs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0992889', 'cui_str': 'Ritonavir 100 MG'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C3839656', 'cui_str': 'Modification of diet in renal disease formula'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0775406,"mL/min/1.73m 2  on 2DRs and 3DRs, respectively ( p  = 0.0002), while serum levels of cystatin C were stable in both arms","[{'ForeName': 'Malte', 'Initials': 'M', 'LastName': 'Monin', 'Affiliation': 'Bonn University Hospital, Bonn, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Kümmerle', 'Affiliation': 'Private Practice am Ebertplatz, Cologne, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Technical University of Munich, School of Medicine, University Hospital Klinikum Rechts der Isar, Munich, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Cordes', 'Affiliation': 'Private Practice, Berlin, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Heiken', 'Affiliation': 'Private Practice Georgstrasse, Hannover, Germany.'}, {'ForeName': 'Hans-Jürgen', 'Initials': 'HJ', 'LastName': 'Stellbrink', 'Affiliation': 'ICH Study Center, Hamburg, Germany.'}, {'ForeName': 'Ivanka', 'Initials': 'I', 'LastName': 'Krznaric', 'Affiliation': 'Study Center of Infectiology Prenzlauer Berg, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Scholten', 'Affiliation': 'Private Practice Hohenstaufenring, Cologne, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Jensen', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Jessen', 'Affiliation': 'Praxis Jessen2\u2009+\u2009Kollegen, Private Practice, Berlin, Germany.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Obst', 'Affiliation': 'University of Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Spornraft-Ragaller', 'Affiliation': 'University of Dresden, Dresden, Germany.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Khaykin', 'Affiliation': 'Private Practice, Frankfurt, Germany.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Balogh', 'Affiliation': 'MUC Research, Munich, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Wolf', 'Affiliation': 'MUC Research, Munich, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Bidner', 'Affiliation': 'Technical University of Munich, School of Medicine, University Hospital Klinikum Rechts der Isar, Munich Study Center, Munich, Germany.'}, {'ForeName': 'Christoph D', 'Initials': 'CD', 'LastName': 'Spinner', 'Affiliation': 'Technical University of Munich, School of Medicine, University Hospital Klinikum Rechts der Isar, Munich, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Boesecke', 'Affiliation': 'Bonn University Hospital, Bonn, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",HIV research & clinical practice,[]
2926,35234569,"Interval prolongation of etanercept in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis: a randomized controlled trial.","OBJECTIVE


The majority of patients with a rheumatic disease treated with etanercept may be overexposed. Data regarding etanercept tapering are scarce, particularly in psoriatic arthritis (PsA) and ankylosing spondylitis (AS). We compared extending the dose interval to continuation of the standard dose and studied the success rate of etanercept discontinuation. Etanercept concentrations were measured throughout the study.
METHOD


160 patients with rheumatoid arthritis (RA), PsA, or AS with sustained minimal disease activity (MDA) were enrolled in this 18-month, open-label, randomized controlled trial. The intervention group doubled the dosing interval at baseline and discontinued etanercept 6 months later. The control group continued the standard dose for 6 months and doubled the dosing-interval thereafter. The primary outcome was the proportion of patients maintaining MDA at 6 month follow-up.
RESULTS


At 6 months, MDA status was maintained in 47 patients (63%) in the intervention group and 56 (74%) in the control group (p = 0.15), with comparable results in all rheumatic diseases. And median etanercept concentrations decreased from 1.50 µg/mL (interquartile range 1.06- 2.65) to 0.46 µg/mL (0.28-0.92). In total, 40% discontinued etanercept successfully with maintained MDA for at least 6 months.
CONCLUSION


Etanercept tapering can be done without losing efficacy in RA, PsA, and AS patients in sustained MDA. A substantial proportion of patients could stop etanercept for at least 6 months. In many patients, low drug concentrations proved sufficient to control disease activity. However, the risk of minor and major flares is substantial, even in patients continuing standard dosing.",2022,"At 6 months, MDA status was maintained in 47 patients (63%) in the intervention group and 56 (74%) in the control group (p = 0.15), with comparable results in all rheumatic diseases.","['patients with a rheumatic disease treated with', '160 patients with rheumatoid arthritis (RA), PsA, or AS with sustained minimal disease activity (MDA', 'rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis']",['etanercept'],"['Interval prolongation', 'median etanercept concentrations', 'MDA status', 'Etanercept concentrations', 'proportion of patients maintaining MDA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0717758', 'cui_str': 'Etanercept'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",160.0,0.276035,"At 6 months, MDA status was maintained in 47 patients (63%) in the intervention group and 56 (74%) in the control group (p = 0.15), with comparable results in all rheumatic diseases.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ruwaard', 'Affiliation': 'Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': ""L' Ami"", 'Affiliation': 'Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Kneepkens', 'Affiliation': 'Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Clm', 'Initials': 'C', 'LastName': 'Krieckaert', 'Affiliation': 'Department of Rheumatology, Amsterdam UMC | Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Nurmohamed', 'Affiliation': 'Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Hooijberg', 'Affiliation': 'Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Awr', 'Initials': 'A', 'LastName': 'van Kuijk', 'Affiliation': 'Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'van Denderen', 'Affiliation': 'Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Burgemeister', 'Affiliation': 'Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rispens', 'Affiliation': 'Department of Immunopathology, Sanquin Research and Landsteiner Laboratory Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boers', 'Affiliation': 'Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Wolbink', 'Affiliation': 'Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.'}]",Scandinavian journal of rheumatology,['10.1080/03009742.2022.2028364']
2927,35234726,"Does CPM Improve Outcomes after Elbow Contracture Release?: Commentary on an article by Shawn W. O'Driscoll, PhD, MD, et al.: ""Prospective Randomized Trial of Continuous Passive Motion Versus Physical Therapy After Arthroscopic Release of Elbow Contracture"".",,2022,,[],"['Continuous Passive Motion', 'Physical Therapy']",[],[],"[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]",[],,0.0154747,,"[{'ForeName': 'Jennifer Moriatis', 'Initials': 'JM', 'LastName': 'Wolf', 'Affiliation': 'Department of Orthopaedic Surgery, The University of Chicago, Chicago, Illinois.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.21.01410']
2928,35234723,Prospective Randomized Trial of Continuous Passive Motion Versus Physical Therapy After Arthroscopic Release of Elbow Contracture.,"BACKGROUND


Continuous passive motion (CPM) has been used for decades, but we are not aware of any randomized controlled trials (RCTs) in which CPM has been compared with physical therapy (PT) for rehabilitation following release of elbow contracture.
METHODS


In this single-blinded, single-center RCT, we randomly assigned patients undergoing arthroscopic release of elbow contracture to a rehabilitation protocol involving either CPM or PT. The primary outcomes were the rate of recovery and the arc of elbow motion (range of motion) at 1 year. The rate of recovery was evaluated by measuring range of motion at 6 weeks and 3 months. The secondary outcomes included other range-of-motion-related outcomes, patient-reported outcome measures (PROMs), flexion strength and endurance, grip strength, and forearm circumference at multiple time points.
RESULTS


A total of 24 patients were assigned to receive CPM, and 27 were assigned to receive PT. At 1 year, CPM was superior to PT with regard to the range of motion, with an estimated treatment difference of 9° (95% confidence interval [CI], 3° to 16°; p = 0.007). Similarly, the use of CPM led to a greater range of motion at 6 weeks and 3 months than PT. The percentage of lost motion recovered at 1 year was higher in the CPM group (51%) than in the PT group (36%) (p = 0.01). The probability of restoring a functional range of motion at 1 year was 62% higher in the CPM group than in the PT group (risk ratio for functional range of motion, 1.62; 95% CI, 1.01 to 2.61; p = 0.04). PROM scores were similar in the 2 groups at all time points, except for a difference in the American Shoulder and Elbow Surgeons (ASES) elbow function subscale, in favor of CPM, at 6 weeks. The use of CPM decreased swelling and reduced the loss of flexion strength, flexion endurance, and grip strength on day 3, with no between-group differences thereafter.
CONCLUSIONS


Among patients undergoing arthroscopic release of elbow contracture, those who received CPM obtained a faster recovery and a greater range of motion at 1 year, with a higher chance of restoration of functional elbow motion than those who underwent routine PT.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2022,"The use of CPM decreased swelling and reduced the loss of flexion strength, flexion endurance, and grip strength on day 3, with no between-group differences thereafter.
","['A total of 24 patients', 'patients undergoing arthroscopic release of elbow contracture']","['Physical Therapy', 'PT', 'CPM', 'physical therapy (PT', 'Continuous passive motion (CPM', 'Continuous Passive Motion', 'arthroscopic release of elbow contracture to a rehabilitation protocol involving either CPM or PT']","['PROM scores', 'American Shoulder and Elbow Surgeons (ASES) elbow function subscale', 'loss of flexion strength, flexion endurance, and grip strength', 'functional elbow motion', 'range-of-motion-related outcomes, patient-reported outcome measures (PROMs), flexion strength and endurance, grip strength, and forearm circumference at multiple time points', 'probability of restoring a functional range of motion at 1 year', 'rate of recovery', 'percentage of lost motion', 'rate of recovery and the arc of elbow motion (range of motion']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0409338', 'cui_str': 'Flexion contracture - elbow'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0409338', 'cui_str': 'Flexion contracture - elbow'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0015944', 'cui_str': 'Premature rupture of membranes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}]",24.0,0.0703611,"The use of CPM decreased swelling and reduced the loss of flexion strength, flexion endurance, and grip strength on day 3, with no between-group differences thereafter.
","[{'ForeName': 'Shawn W', 'Initials': 'SW', 'LastName': ""O'Driscoll"", 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jorge Rojas', 'Initials': 'JR', 'LastName': 'Lievano', 'Affiliation': ''}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Morrey', 'Affiliation': ''}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Sanchez-Sotelo', 'Affiliation': ''}, {'ForeName': 'Dave R', 'Initials': 'DR', 'LastName': 'Shukla', 'Affiliation': ''}, {'ForeName': 'Tammy S', 'Initials': 'TS', 'LastName': 'Olson', 'Affiliation': ''}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Fitzsimmons', 'Affiliation': ''}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Vaichinger', 'Affiliation': ''}, {'ForeName': 'Maegan N', 'Initials': 'MN', 'LastName': 'Shields', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.21.00685']
2929,35234673,Intravitreal Nesvacumab (Anti-Angiopoietin 2) Plus Aflibercept in Diabetic Macular Edema: The Phase 2 RUBY Randomized Trial.,"PURPOSE


To compare intravitreal nesvacumab (anti-angiopoietin 2) plus aflibercept with intravitreal aflibercept injection (IAI) in diabetic macular edema (DME).
METHODS


Eyes (n=302) were randomized (1:2:3) to nesvacumab 3 mg+aflibercept 2 mg (LD combo), nesvacumab 6 mg+aflibercept 2 mg (HD combo), or IAI 2 mg at baseline, weeks 4 and 8. LD combo continued every 8 weeks (q8w). HD combo was re-randomized at week 12 to q8w or every 12 weeks (q12w); IAI to q8w, q12w or HD combo q8w through week 32.
RESULTS


Week 12 BCVA gains for LD and HD combos vs. IAI were 6.8, 8.5, and 8.8 letters; week 36 changes were similar. CST reductions at week 12 were -169.4, -184.0, and -174.6 µm (nominal P=0.0183, HD combo vs. IAI); week 36 reductions for LD combo and HD combo q8w and q12w versus IAI were -210.4, -223.4 and -193.7 versus -61.9 µm (nominal P<0.05). At week 12, 13.3% and 21.3% vs. 15.2% had ≥2-step DRSS improvement (LD and HD combos vs. IAI) and 59.6% and 66.3% vs. 53.7% had complete foveal center fluid resolution. Safety was comparable across groups.
CONCLUSION


Nesvacumab+aflibercept demonstrated no additional visual benefit over IAI. Anatomic improvements with HD combo may warrant further investigation.",2022,"Safety was comparable across groups.
","['diabetic macular edema (DME', 'Eyes (n=302', 'Diabetic Macular Edema']","['Intravitreal Nesvacumab (Anti-Angiopoietin 2) Plus Aflibercept', 'nesvacumab 3 mg+aflibercept 2 mg (LD combo), nesvacumab 6 mg+aflibercept 2 mg (HD combo), or IAI 2 mg at baseline, weeks 4 and 8', 'Nesvacumab+aflibercept', 'intravitreal nesvacumab (anti-angiopoietin 2) plus aflibercept with intravitreal aflibercept injection (IAI']","['Safety', '≥2-step DRSS improvement', 'CST reductions']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0540511', 'cui_str': 'Angiopoietin 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",302.0,0.0554278,"Safety was comparable across groups.
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'Retina Consultants of Texas (Retina Consultants of America), Houston, Texas; Retina-Vitreous Associates Medical Group & University of Southern California/Keck School of Medicine in Los Angeles, Los Angeles, California; Retina Foundation of the Southwest, Dallas, Texas; Regeneron Pharmaceuticals, Inc., Tarrytown, New York; Bayer AG, Berlin, Germany; Bayer Consumer Care AG, Basel, Switzerland; Department of Ophthalmology, Charité Universitätsmedizin Berlin, Germany Ophthalmic Consultants of Boston, Boston, Massachusetts.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Boyer', 'Affiliation': ''}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Csaky', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vitti', 'Affiliation': ''}, {'ForeName': 'Lorah', 'Initials': 'L', 'LastName': 'Perlee', 'Affiliation': ''}, {'ForeName': 'Karen W', 'Initials': 'KW', 'LastName': 'Chu', 'Affiliation': ''}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Asmus', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leal', 'Affiliation': ''}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zeitz', 'Affiliation': ''}, {'ForeName': 'Yenchieh', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schmelter', 'Affiliation': ''}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': ''}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000003441']
2930,35234661,Effects of SGLT2 inhibition on lipid transport in adipose tissue in type 2 diabetes.,"SGLT2 inhibition induces an insulin-independent reduction in plasma glucose causing increased lipolysis and subsequent lipid oxidation by energy-consuming tissues. However, it is unknown whether SGLT2 inhibition also affects lipid storage in adipose tissue. Therefore, we aimed to determine the effects of SGLT2 inhibition on lipid storage and lipolysis in adipose tissue. We performed a randomized, double-blind, placebo-controlled crossover design of four weeks of empagliflozin 25 mg and placebo once-daily in 13 individuals with type 2 diabetes treated with metformin. Adipose tissue fatty acid uptake, lipolysis rate and clearance were measured by 11C-palmitate PET/CT. Adipose tissue glucose uptake was measured by 18F-FDG PET/CT. Protein and gene expression of pathways involved in lipid storage and lipolysis were measured in biopsies of abdominal subcutaneous adipose tissue. Subjects were weight stable, which allowed us to quantify the weight loss independent effects of SGLT2 inhibition. We found that SGLT2 inhibition did not affect FFA uptake in abdominal subcutaneous adipose tissue, but increased FFA uptake in visceral adipose tissue by 27% (p<0.05). In addition, SGLT2 inhibition reduced GLUT4 protein (p=0.03) and mRNA content (p=0.01) in abdominal subcutaneous adipose tissue, but without affecting glucose uptake. In addition, SGLT2 inhibition decreased expression of genes involved in insulin signaling in adipose tissue. We concludethat SGLT2 inhibition reduces GLUT4 gene and protein expression in abdominal subcutaneous adipose tissue, which could indicate a rebalancing of substrate utilization away from glucose oxidation and lipid storage capacity through reduced glycerol formation.",2022,"In addition, SGLT2 inhibition reduced GLUT4 protein (p=0.03) and mRNA content (p=0.01) in abdominal subcutaneous adipose tissue, but without affecting glucose uptake.","['adipose tissue in type 2 diabetes', '13 individuals with type 2 diabetes treated with']","['SGLT2 inhibition', 'metformin', 'empagliflozin 25 mg and placebo', 'placebo']","['lipid storage and lipolysis in adipose tissue', 'Adipose tissue fatty acid uptake, lipolysis rate and clearance', 'GLUT4 protein', 'Adipose tissue glucose uptake', 'FFA uptake']","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3848772', 'cui_str': 'empagliflozin 25 MG [Jardiance]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0166441', 'cui_str': 'Insulin-Responsive Glucose Transporter'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}]",13.0,0.0917968,"In addition, SGLT2 inhibition reduced GLUT4 protein (p=0.03) and mRNA content (p=0.01) in abdominal subcutaneous adipose tissue, but without affecting glucose uptake.","[{'ForeName': 'Katrine M', 'Initials': 'KM', 'LastName': 'Lauritsen', 'Affiliation': 'K Lauritsen, Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Esben', 'Initials': 'E', 'LastName': 'Søndergaard', 'Affiliation': 'E Søndergaard, Aarhus Universitetshospital, Aarhus N, 8200, Denmark.'}, {'ForeName': 'Jens Hohwü', 'Initials': 'JH', 'LastName': 'Voigt', 'Affiliation': 'J Voigt, Steno Diabetes Center Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Steen Bønløkke', 'Initials': 'SB', 'LastName': 'Pedersen', 'Affiliation': 'S Pedersen, Department of Endocrinology and Internal medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Troels K', 'Initials': 'TK', 'LastName': 'Hansen', 'Affiliation': 'T Hansen, Steno diabetes center Aarhus, Aarhus , Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'N Møller, Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'N Jessen, Department of Biomedicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lars C', 'Initials': 'LC', 'LastName': 'Gormsen', 'Affiliation': 'L Gormsen, Department of Nuclear Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Esben', 'Initials': 'E', 'LastName': 'Søndergaard', 'Affiliation': 'E Søndergaard, Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",Endocrine connections,['10.1530/EC-21-0558']
2931,35234659,Heart Watch Study: protocol for a pragmatic randomised controlled trial.,"INTRODUCTION


Personal digital devices that provide health information, such as the Apple Watch, have developed an increasing array of cardiopulmonary tracking features which have received regulatory clearance and are directly marketed to consumers. Despite their widespread and increasing use, data about the impact of personal digital device use on patient-reported outcomes and healthcare utilisation are sparse. Among a population of patients with atrial fibrillation and/or atrial flutter undergoing cardioversion, our primary aim is to determine the impact of the heart rate measurement, irregular rhythm notification, and ECG features of the Apple Watch on quality of life and healthcare utilisation.
METHODS AND ANALYSIS


We are conducting a prospective, open-label multicentre pragmatic randomised clinical trial, leveraging a unique patient-centred health data sharing platform for enrolment and follow-up. A total of 150 patients undergoing cardioversion for atrial fibrillation or atrial flutter will be randomised 1:1 to receive the Apple Watch Series 6 or Withings Move at the time of cardioversion. The primary outcome is the difference in the Atrial Fibrillation Effect on QualiTy-of-life global score at 6 months postcardioversion. Secondary outcomes include inpatient and outpatient healthcare utilisation. Additional secondary outcomes include a comparison of the Apple Watch ECG and pulse oximeter features with gold-standard data obtained in routine clinical care settings.
ETHICS AND DISSEMINATION


The Institutional Review Boards at Yale University, Mayo Clinic, and Duke University Health System have approved the trial protocol. This trial will provide important data to policymakers, clinicians and patients about the impact of the heart rate, irregular rhythm notification, and ECG features of widely used personal digital devices on patient quality of life and healthcare utilisation. Findings will be disseminated to study participants, at professional society meetings and in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT04468321.",2021,The primary outcome is the difference in the Atrial Fibrillation Effect on QualiTy-of-life global score at 6 months postcardioversion.,"['patients with atrial fibrillation and/or atrial flutter undergoing cardioversion', '150 patients undergoing cardioversion for atrial fibrillation or atrial flutter']",[],"['inpatient and outpatient healthcare utilisation', 'comparison of the Apple Watch ECG and pulse oximeter features with gold-standard data obtained in routine clinical care settings', 'Atrial Fibrillation Effect on QualiTy-of-life global score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C4321486', 'cui_str': '150'}]",[],"[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",150.0,0.277206,The primary outcome is the difference in the Atrial Fibrillation Effect on QualiTy-of-life global score at 6 months postcardioversion.,"[{'ForeName': 'Sanket S', 'Initials': 'SS', 'LastName': 'Dhruva', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center, San Francisco, California, USA sanket.dhruva@ucsf.edu.'}, {'ForeName': 'Nilay D', 'Initials': 'ND', 'LastName': 'Shah', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Sreekanth', 'Initials': 'S', 'LastName': 'Vemulapalli', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Deshmukh', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, New York, USA.'}, {'ForeName': 'Alexis L', 'Initials': 'AL', 'LastName': 'Beatty', 'Affiliation': 'Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, California, USA.'}, {'ForeName': 'Ginger M', 'Initials': 'GM', 'LastName': 'Gamble', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut, USA.'}, {'ForeName': 'James V', 'Initials': 'JV', 'LastName': 'Freeman', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hummel', 'Affiliation': 'Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Piccini', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Akar', 'Affiliation': 'Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Keondae', 'Initials': 'K', 'LastName': 'Ervin', 'Affiliation': 'National Evaluation System for health Technology Coordinating Center (NESTcc), Medical Device Innovation Consortium, Arlington, Virginia, USA.'}, {'ForeName': 'Kristine L', 'Initials': 'KL', 'LastName': 'Arges', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Emanuel', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Noseworthy', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Hu', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Bartlett', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Ross', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut, USA.'}]",BMJ open,['10.1136/bmjopen-2021-054550']
2932,35235002,Immune response to the third COVID-19 vaccine dose is related to lymphocyte count in multiple sclerosis patients treated with fingolimod.,"BACKGROUND


The majority of multiple sclerosis [MS] patients treated with fingolimod fail to develop a protective level of IgG humoral and adaptive cellular immune responses following full BNT162b2 SARS-CoV-2 vaccination.
OBJECTIVE


To compare the efficacy of the third COVID-19 vaccine dose in vaccine non-responders fingolimod-treated MS patients.
STUDY DESIGN


This is a prospective 3-month, single-center, randomized clinical trial.
METHODS


Twenty relapsing MS patients who had been on fingolimod therapy ≥ 12 months and failed to develop humoral IgG immune response to 2-dose Pfizer BNT162b2 COVID-19 vaccination were randomized into two groups: fingolimod-continuation group and fingolimod-discontinuation group. Humoral and memory cellular immune responses were assessed within 1 and 3 months following the third Pfizer BNT162b2 vaccine dose and compared between the groups.
RESULTS


A higher rate of patients in the fingolimod-discontinuation group [n = 8/10] compared to fingolimod-continuation group [n = 2/10] developed positive SARS-COV-2 IgG. Median IgG titer 1 month following the third dose was 202.3 BAU/ml vs. 26.4 BAU/ml, respectively, p = 0.022. The development of IgG humoral response correlated with absolute lymphocyte count. Specific SARS-COV-2 memory B cell and T cell immune responses were not detected in both groups, either at 1 month or 3 months following the third COVID-19 vaccine dose.
CONCLUSIONS


Short period of fingolimod treatment discontinuation was associated with the development of humoral protection but not with adaptive cellular immunity.",2022,"Specific SARS-COV-2 memory B cell and T cell immune responses were not detected in both groups, either at 1 month or 3 months following the third COVID-19 vaccine dose.
","['vaccine non-responders fingolimod-treated MS patients', 'Twenty relapsing MS patients who had been on fingolimod therapy\u2009≥\u200912\xa0months and failed to develop humoral IgG immune response to 2-dose Pfizer BNT162b2 COVID-19 vaccination', 'multiple sclerosis patients treated with fingolimod']",['fingolimod-continuation group and fingolimod-discontinuation group'],"['positive SARS-COV-2 IgG. Median IgG titer', 'Specific SARS-COV-2 memory B cell and T cell immune responses', 'Humoral and memory cellular immune responses', 'IgG humoral response', 'Immune response']","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}]",,0.0526329,"Specific SARS-COV-2 memory B cell and T cell immune responses were not detected in both groups, either at 1 month or 3 months following the third COVID-19 vaccine dose.
","[{'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Achiron', 'Affiliation': 'Neuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel. anat.achiron@sheba.health.gov.il.'}, {'ForeName': 'Mathilda', 'Initials': 'M', 'LastName': 'Mandel', 'Affiliation': 'Neuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gurevich', 'Affiliation': 'Neuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.'}, {'ForeName': 'Sapir', 'Initials': 'S', 'LastName': 'Dreyer-Alster', 'Affiliation': 'Neuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Magalashvili', 'Affiliation': 'Neuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.'}, {'ForeName': 'Polina', 'Initials': 'P', 'LastName': 'Sonis', 'Affiliation': 'Neuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Dolev', 'Affiliation': 'Neuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'Menascu', 'Affiliation': 'Neuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Harari', 'Affiliation': 'Neuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Flechter', 'Affiliation': 'Neuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Falb', 'Affiliation': 'Neuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.'}]",Journal of neurology,['10.1007/s00415-022-11030-0']
2933,35234999,"Letter to the editor regarding ""Is capsulorrhaphy a necessary step during open reduction of developmental dysplasia of the hip? A randomized controlled trial"".",,2022,,[],[],[],[],[],[],,0.155195,,"[{'ForeName': 'Sadettin', 'Initials': 'S', 'LastName': 'Ciftci', 'Affiliation': 'Faculty of Medicine, Department of Orthopaedics and Traumatology, Selcuk University, Alaeddin Keykubat Campus, 42100, Selcuklu, Konya, Turkey. dr.sadettinciftci@gmail.com.'}, {'ForeName': 'Bahattin Kerem', 'Initials': 'BK', 'LastName': 'Aydın', 'Affiliation': 'Faculty of Medicine, Department of Orthopaedics and Traumatology, Selcuk University, Alaeddin Keykubat Campus, 42100, Selcuklu, Konya, Turkey.'}]",International orthopaedics,['10.1007/s00264-022-05360-x']
2934,35234931,The Individual Placement and Support (IPS) in Pain Trial: A randomized controlled trial of IPS for patients with chronic pain conditions.,"OBJECTIVES


Although complex pain conditions require an interdisciplinary approach, employment services are rarely provided in pain centers. Individual Placement and Support (IPS) is an effective approach to increase work participation among patients with severe mental illness, and recent evidence suggests that this method may be successfully repurposed to new target groups.We aimed to investigate the effectiveness of IPS integrated with interdisciplinary treatment as usual (TAU) for patients with chronic pain in a tertiary pain center.
METHODS


A randomized controlled trial (RCT) comparing IPS integrated with TAU (n = 38) with TAU alone (n = 20) was conducted. Participants were patients with chronic pain; aged 18-65; currently on long-term sick leave, disability benefits, or unemployed. The primary outcome was employment within 12 months after enrollment, with additional long-term follow-up after 24 months. Secondary outcomes included health and quality of life, measured at baseline, 6 and 12 months.
RESULTS


During 12-month follow-up 52.8% in the IPS group and 38.9% in the TAU group had attained employment. The difference increased during 24-month follow-up, but did not reach statistical significance. Findings on secondary outcomes were generally non-significant.
CONCLUSIONS


The IPS in Pain trial is the first study to evaluate the effect of IPS for patients with chronic pain conditions. It shows that IPS can be integrated into daily practice of interdisciplinary pain treatment with employment rates exceeding 50% in one year, and a clear trend in favor of the IPS group. Results did however not reach significance. Larger RCTs are needed to draw clear conclusions about effectiveness.",2022,During 12-month follow-up 52.8% in the IPS group and 38.9% in the TAU group had attained employment.,"['patients with chronic pain in a tertiary pain center', 'Participants were patients with chronic pain; aged 18-65; currently on long-term sick leave, disability benefits, or unemployed', 'patients with severe mental illness', 'Pain Trial', 'patients with chronic pain conditions']","['IPS integrated with interdisciplinary treatment as usual (TAU', 'IPS', 'Individual Placement and Support (IPS', 'TAU', 'TAU alone', 'IPS integrated with TAU']",['health and quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C4750554', 'cui_str': 'Individual Placement and Support'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.241142,During 12-month follow-up 52.8% in the IPS group and 38.9% in the TAU group had attained employment.,"[{'ForeName': 'Vigdis', 'Initials': 'V', 'LastName': 'Sveinsdottir', 'Affiliation': 'Department of Pain Management and Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Henrik Børsting', 'Initials': 'HB', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Pain Management and Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Tone Marte', 'Initials': 'TM', 'LastName': 'Ljosaa', 'Affiliation': 'Department of Pain Management and Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Lene Therese Bergerud', 'Initials': 'LTB', 'LastName': 'Linnemørken', 'Affiliation': 'Department of Pain Management and Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Knutzen', 'Affiliation': 'IPS Norge AS, Oslo, Norway.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Ghiasvand', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Silje Endresen', 'Initials': 'SE', 'LastName': 'Reme', 'Affiliation': 'Department of Pain Management and Research, Oslo University Hospital, Oslo, Norway.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnac032']
2935,35234890,Communicating risk to promote colorectal cancer screening: a multi-method study to test tailored versus targeted message strategies.,"Colorectal cancer (CRC) screening rates are suboptimal, partly due to poor communication about CRC risk. More effective methods are needed to educate patients, but little research has examined best practices for communicating CRC risk. This multi-method study tests whether tailoring CRC risk information increases screening intentions. Participants (N = 738) were randomized with a 2:2:1 allocation to tailored, targeted, and control message conditions. The primary outcome was intention to screen for CRC (yes/no). Additional variables include perceived message relevance, perceived susceptibility to CRC, and free-text comments evaluating the intervention. A chi-square test determined differences in the proportion of participants who intended to complete CRC screening by condition. A logistic-based path analysis explored mediation. Free-text comments were analyzed using advanced topic modeling analysis. CRC screening intentions were highest in the tailored intervention and significantly greater than control (P = 0.006). The tailored message condition significantly increased message relevance compared with control (P = 0.027) and targeted conditions (P = 0.002). The tailored condition also increased susceptibility (P < 0.001) compared with control, which mediated the relationship between the tailored condition and intention to screen (b = 0.04, SE = 0.02, 95% confidence interval = 0.02, 0.09). The qualitative data reflect similar trends. The theoretical mechanisms and practical implications of tailoring health education materials about CRC risk are discussed.",2022,The tailored message condition significantly increased message relevance compared with control (P = 0.027) and targeted conditions (P = 0.002).,['Participants (N\u2009=\u2009738'],[],"['message relevance', 'intention to screen for CRC (yes/no', 'CRC screening intentions']",[],[],"[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1298907', 'cui_str': 'Yes'}]",738.0,0.0547226,The tailored message condition significantly increased message relevance compared with control (P = 0.027) and targeted conditions (P = 0.002).,"[{'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Neil', 'Affiliation': 'TSET Health Promotion Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center,655 Research Parkway, Oklahoma City, OK 73104,USA.'}, {'ForeName': 'Naomi D', 'Initials': 'ND', 'LastName': 'Parker', 'Affiliation': 'STEM Translational Communication Center, College of Journalism and Communications, University of Florida, 2043 Weimer Hall, Gainesville, FL 32611, USA.'}, {'ForeName': 'Yulia A', 'Initials': 'YA', 'LastName': 'Levites Strekalova', 'Affiliation': 'STEM Translational Communication Center, College of Journalism and Communications, University of Florida, 2043 Weimer Hall, Gainesville, FL 32611, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Duke', 'Affiliation': 'Department of Statistics, North Carolina State University, 2311 Stinson Drive, 5109 SAS Hall, Raleigh, NC 27695, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Hematology & Oncology, College of Medicine, University of Florida, 1600 SW Archer Road, Gainesville, FL 32610, USA.'}, {'ForeName': 'Janice L', 'Initials': 'JL', 'LastName': 'Krieger', 'Affiliation': 'STEM Translational Communication Center, College of Journalism and Communications, University of Florida, 2043 Weimer Hall, Gainesville, FL 32611, USA.'}]",Health education research,['10.1093/her/cyac002']
2936,35234881,Effects of a Lifestyle Intervention to Prevent Deterioration in Glycemic Status Among South Asian Women With Recent Gestational Diabetes: A Randomized Clinical Trial.,"Importance


Women with recent gestational diabetes (GDM) have increased risk of developing type 2 diabetes.
Objective


To investigate whether a resource-appropriate and context-appropriate lifestyle intervention could prevent glycemic deterioration among women with recent GDM in South Asia.
Design, Setting, and Participants


This randomized, participant-unblinded controlled trial investigated a 12-month lifestyle intervention vs usual care at 19 urban hospitals in India, Sri Lanka, and Bangladesh. Participants included women with recent diagnosis of GDM who did not have type 2 diabetes at an oral glucose tolerance test (OGTT) 3 to 18 months postpartum. They were enrolled from November 2017 to January 2020, and follow-up ended in January 2021. Data were analyzed from April to July 2021.
Interventions


A 12-month lifestyle intervention focused on diet and physical activity involving group and individual sessions, as well as remote engagement, adapted to local context and resources. This was compared with usual care.
Main Outcomes and Measures


The primary outcome was worsening category of glycemia based on OGTT using American Diabetes Association criteria: (1) normal glucose tolerance to prediabetes (ie, impaired fasting glucose or impaired glucose tolerance) or type 2 diabetes or (2) prediabetes to type 2 diabetes. The primary analysis consisted of a survival analysis of time to change in glycemic status at or prior to the final patient visit, which occurred at varying times after 12 months for each patient. Secondary outcomes included new-onset type 2 diabetes and change in body weight.
Results


A total of 1823 women (baseline mean [SD] age, 30.9 [4.9] years and mean [SD] body mass index, 26.6 [4.6]) underwent OGTT at a median (IQR) 6.5 (4.8-8.2) months postpartum. After excluding 160 women (8.8%) with type 2 diabetes, 2 women (0.1%) who met other exclusion criteria, and 49 women (2.7%) who did not consent or were uncontactable, 1612 women were randomized. Subsequently, 11 randomized participants were identified as ineligible and excluded from the primary analysis, leaving 1601 women randomized (800 women randomized to the intervention group and 801 women randomized to usual care). These included 600 women (37.5%) with prediabetes and 1001 women (62.5%) with normoglycemia. Among participants randomized to the intervention, 644 women (80.5%) received all program content, although COVID-19 lockdowns impacted the delivery model (ie, among 644 participants who engaged in all group sessions, 476 women [73.9%] received some or all content through individual engagement, and 315 women [48.9%] received some or all content remotely). After a median (IQR) 14.1 (11.4-20.1) months of follow-up, 1308 participants (81.2%) had primary outcome data. The intervention, compared with usual care, did not reduce worsening glycemic status (204 women [25.5%] vs 217 women [27.1%]; hazard ratio, 0.92; [95% CI, 0.76-1.12]; P = .42) or improve any secondary outcome.
Conclusions and Relevance


This study found that a large proportion of women in South Asian urban settings developed dysglycemia soon after a GDM-affected pregnancy and that a lifestyle intervention, modified owing to the COVID-19 pandemic, did not prevent subsequent glycemic deterioration. These findings suggest that alternate or additional approaches are needed, especially among high-risk individuals.
Trial Registration


Clinical Trials Registry of India Identifier: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry Identifier: SLCTR/2017/001; and ClinicalTrials.gov Identifier: NCT03305939.",2022,"The intervention, compared with usual care, did not reduce worsening glycemic status (204 women [25.5%] vs 217 women [27.1%]; hazard ratio, 0.92; [95% CI, 0.76-1.12]; P = .42) or improve any secondary outcome.
","['644 women (80.5%) received', 'women in South Asian urban settings', 'at 19 urban hospitals in India, Sri Lanka, and Bangladesh', 'India Identifier', '160 women (8.8%) with type 2 diabetes, 2 women (0.1%) who met other exclusion criteria, and 49 women (2.7%) who did not consent or were uncontactable, 1612 women were randomized', '600 women (37.5%) with prediabetes and 1001 women (62.5%) with normoglycemia', '644 participants who engaged in all group sessions, 476 women [73.9%] received some or all content through individual engagement, and 315 women [48.9%] received some or all content remotely', '1823 women', 'Participants included women with recent diagnosis of GDM who did not have type 2 diabetes at an oral glucose tolerance test (OGTT', 'With Recent Gestational Diabetes', 'Importance\n\n\nWomen with recent gestational diabetes (GDM', '11 randomized participants were identified as ineligible and excluded from the primary analysis, leaving 1601 women randomized (800 women randomized to the intervention group and 801 women randomized to usual care', 'They were enrolled from November 2017 to January 2020, and follow-up ended in January 2021', 'South Asian Women', 'women with recent GDM in South Asia']","['all program content, although COVID-19 lockdowns impacted the delivery model', 'lifestyle intervention vs usual care', 'Lifestyle Intervention', 'diet and physical activity involving group and individual sessions', 'resource-appropriate and context-appropriate lifestyle intervention']","['survival analysis of time to change in glycemic status', 'worsening glycemic status', 'new-onset type 2 diabetes and change in body weight', 'glycemic deterioration', 'worsening category of glycemia based on OGTT using American Diabetes Association criteria: (1) normal glucose tolerance to prediabetes (ie, impaired fasting glucose or impaired glucose tolerance) or type 2 diabetes or (2) prediabetes to type 2 diabetes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517742', 'cui_str': '37.5'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0003980', 'cui_str': 'Asia'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0449255', 'cui_str': 'Context'}]","[{'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}]",1612.0,0.201433,"The intervention, compared with usual care, did not reduce worsening glycemic status (204 women [25.5%] vs 217 women [27.1%]; hazard ratio, 0.92; [95% CI, 0.76-1.12]; P = .42) or improve any secondary outcome.
","[{'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Yashdeep', 'Initials': 'Y', 'LastName': 'Gupta', 'Affiliation': 'Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Deksha', 'Initials': 'D', 'LastName': 'Kapoor', 'Affiliation': 'Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Josyula K', 'Initials': 'JK', 'LastName': 'Lakshmi', 'Affiliation': 'George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Devarsetty', 'Initials': 'D', 'LastName': 'Praveen', 'Affiliation': 'Faculty of Medicine and Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Amritendu', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': 'George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'Faculty of Medicine and Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Aliya', 'Initials': 'A', 'LastName': 'Naheed', 'Affiliation': 'Initiative for Noncommunicable Diseases, Health Systems and Population Studies Division, International Centre for Diarrhoeal Disease Research (ICDDR, B), Dhaka, Bangladesh.'}, {'ForeName': 'Asita', 'Initials': 'A', 'LastName': 'de Silva', 'Affiliation': 'Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.'}, {'ForeName': 'Ishita', 'Initials': 'I', 'LastName': 'Gupta', 'Affiliation': 'Centre for Chronic Disease Control, New Delhi, India.'}, {'ForeName': 'Noshin', 'Initials': 'N', 'LastName': 'Farzana', 'Affiliation': 'Initiative for Noncommunicable Diseases, Health Systems and Population Studies Division, International Centre for Diarrhoeal Disease Research (ICDDR, B), Dhaka, Bangladesh.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'John', 'Affiliation': 'George Institute for Global Health, Hyderabad, India.'}, {'ForeName': 'Saumiyah', 'Initials': 'S', 'LastName': 'Ajanthan', 'Affiliation': 'Remedium One, Colombo, Sri Lanka.'}, {'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Divakar', 'Affiliation': 'Divakars Speciality Hospital, Bengaluru, India.'}, {'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bhatla', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ankush', 'Initials': 'A', 'LastName': 'Desai', 'Affiliation': 'Department of Medicine, Goa Medical College, Goa, India.'}, {'ForeName': 'Arunasalam', 'Initials': 'A', 'LastName': 'Pathmeswaran', 'Affiliation': 'Department of Public Health, Faculty of Medicine, University of Kelaniya, Sri Lanka.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Centre for Chronic Disease Control, New Delhi, India.'}, {'ForeName': 'Rohina', 'Initials': 'R', 'LastName': 'Joshi', 'Affiliation': 'Faculty of Medicine and Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'Faculty of Medicine and Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Teede', 'Affiliation': 'Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Zoungas', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Faculty of Medicine and Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2022.0773']
2937,35234868,Antibody response in immunocompromised patients after the administration of SARS-CoV-2 vaccine BNT162b2 or mRNA-1273: A randomised controlled trial.,"BACKGROUND


BNT162b2 by Pfizer-BioNTech and mRNA-1273 by Moderna are the most commonly used vaccines to prevent SARS-CoV-2 infections. Head-to-head comparison of the efficacy of these vaccines in immunocompromised patients is lacking.
METHODS


Parallel, two-arm (allocation 1:1), open-label, non-inferiority randomised clinical trial nested into the Swiss HIV Cohort Study and the Swiss Transplant Cohort Study. Patients living with HIV (PLWH) or solid organ transplant recipients (SOTR; i.e. lung and kidney) from these cohorts were randomised to mRNA-1273 or BNT162b2. The primary endpoint was antibody response to SARS-CoV-2 spike (S1) protein receptor binding domain (Elecsys Anti-SARS-CoV-2 immunoassay, Roche; cut-off ≥0.8 units/ml) 8 weeks after second vaccination. In addition, antibody response was measured with the Antibody CORonavirus Assay 2 (ABCORA 2).
RESULTS


430 patients were randomised and 412 were included in the intention-to-treat analysis (341 PLWH and 71 SOTR). The percentage of patients showing an immune response was 92.1% (95% confidence interval [CI] 88.4-95.8%; 186/202) for mRNA-1273 and 94.3% (95% CI 91.2-97.4; 198/210) for BNT162b2 (difference: 2.2%; 95% CI -7.1 to 2.7), fulfilling non-inferiority of mRNA-1273. With the ABCORA 2 test 89.1% had an immune response to mRNA-1273 (95% CI 84.8-93.4%; 180/202) and 89.5% to BNT162b2 (95% CI 85.4-93.7%; 188/210). Based on the Elecsys test, all PLWH had an antibody response (100.0%; 341/341), while for SOTR only 60.6% (95% CI 49.2-71.9%; 43/71) had titres above the cut-off.
CONCLUSIONS


In immunocompromised patients the antibody response of mRNA-1273 was non-inferior to BNT162b2. PLWH had in general an antibody response, while a high proportion of SOTR had no antibody response.",2022,In immunocompromised patients the antibody response of mRNA-1273 was non-inferior to BNT162b2.,"['Swiss HIV Cohort Study and the Swiss Transplant Cohort Study', '430 patients were randomised and 412 were included in the intention-to-treat analysis (341 PLWH and 71 SOTR', 'immunocompromised patients', 'Patients living with HIV (PLWH) or solid organ transplant recipients (SOTR; i.e. lung and kidney']","['SARS-CoV-2 vaccine BNT162b2 or mRNA-1273', 'PLWH']","['immune response', 'Antibody response', 'antibody response to SARS-CoV-2 spike (S1) protein receptor binding domain (Elecsys Anti-SARS-CoV-2 immunoassay, Roche; cut-off ≥0.8 units/ml', 'antibody response']","[{'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0730400', 'cui_str': 'Solid organ transplant'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0597357', 'cui_str': 'Receptor'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0020980', 'cui_str': 'Immunoassay method'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}]",430.0,0.289096,In immunocompromised patients the antibody response of mRNA-1273 was non-inferior to BNT162b2.,"[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Speich', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Chammartin', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Irene A', 'Initials': 'IA', 'LastName': 'Abela', 'Affiliation': 'University of Zurich, Institute of Medical Virology, Zurich, Switzerland.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Amico', 'Affiliation': 'Clinic for Transplantation Immunology and Nephrology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Marcel P', 'Initials': 'MP', 'LastName': 'Stoeckle', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Eichenberger', 'Affiliation': 'Department of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hasse', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Dominique L', 'Initials': 'DL', 'LastName': 'Braun', 'Affiliation': 'University of Zurich, Institute of Medical Virology, Zurich, Switzerland.'}, {'ForeName': 'Macé M', 'Initials': 'MM', 'LastName': 'Schuurmans', 'Affiliation': 'Division of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Müller', 'Affiliation': 'Nephrology Clinic, University Hospital Zurich, Zürich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tamm', 'Affiliation': 'Clinic of Respiratory Medicine and Pulmonary Cell Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Audigé', 'Affiliation': 'University of Zurich, Institute of Medical Virology, Zurich, Switzerland.'}, {'ForeName': 'Nicolas J', 'Initials': 'NJ', 'LastName': 'Mueller', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andri', 'Initials': 'A', 'LastName': 'Rauch', 'Affiliation': 'Department of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Huldrych F', 'Initials': 'HF', 'LastName': 'Günthard', 'Affiliation': 'University of Zurich, Institute of Medical Virology, Zurich, Switzerland.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Koller', 'Affiliation': 'Clinic for Transplantation Immunology and Nephrology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Trkola', 'Affiliation': 'University of Zurich, Institute of Medical Virology, Zurich, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Briel', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kusejko', 'Affiliation': 'University of Zurich, Institute of Medical Virology, Zurich, Switzerland.'}, {'ForeName': 'Heiner C', 'Initials': 'HC', 'LastName': 'Bucher', 'Affiliation': 'Swiss Transplant Cohorts Study, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciac169']
2938,35234840,"Cardiorenal Risk of Celecoxib compared to Naproxen, or Ibuprofen in Arthritis Patients: Insights from the PRECISION trial.","INTRODUCTION


Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most frequently used drugs both prescribed and over the counter. The long-term cardiovascular safety of NSAIDs in patients with arthritis has engendered controversy. Concerns remain regarding the relative incidence and severity of adverse cardiorenal effects, particularly in arthritis patients with established CV disease, or risk factors for disease as illustrated by the PRECISION trial participants (NCT00346216).
HYPOTHESIS


The selective COX-2 Inhibitor celecoxib has a superior cardiorenal safety profile when compared to ibuprofen or naproxen in the PRECISION population.
METHODS


24,081 patients who required NSAIDs for osteoarthritis or rheumatoid arthritis and had increased CV risk randomly received celecoxib, ibuprofen or naproxen. The current prespecified secondary analysis assessed the incidence, severity and NSAID-related risk of the pre-specified composite cardiorenal outcome [adjudicated renal event, hospitalization for congestive heart failure (CHF), or hospitalization for hypertension (HTN)] in the intention-to-treat (ITT) population. An on-treatment analysis assessed safety in those taking the study medication.
RESULTS


Following a mean treatment duration of 20.3±16.0 months and a mean follow-up of 34.1±13.4 months, the primary cardiorenal composite outcome occurred in 423 patients (1.76%) in the ITT population. Of these 423 patients, 118 (28%) were in the celecoxib, 166 (39%) in the ibuprofen and 139 (33%) in the naproxen group. In a multivariable Cox regression model adjusted for independent clinical variables, celecoxib showed a significantly lower risk compared with ibuprofen (hazard ratio [HR] 0.67, confidence interval [CI] 0.53 - 0.85, p = 0.001) and a trend to lower risk compared to naproxen (HR 0.79, CI 0.61 - 1.00, p = 0.058).In the intention-to-treat analysis, clinically significant renal events occurred in 220 patients with events rates of 0.71%, 1.14% and 0.89% for celecoxib, ibuprofen and naproxen respectively (p = 0.052), while in the on -treatment analysis the rates were 0.52%, 0.91% and 0.78% (p<0.001).
CONCLUSION


In the current era, long-term NSAID use was associated with few cardiorenal events in arthritis patients. At the doses studied, celecoxib displayed fewer renal events and hence more favorable cardiovascular safety compared to ibuprofen or naproxen. These results have considerable clinical implications for practitioners managing individuals with chronic arthritis pain and high risk of impaired renal function and/or heart failure. (Funded by Pfizer) Clinical Trial Registration: NCT00346216.",2022,"At the doses studied, celecoxib displayed fewer renal events and hence more favorable cardiovascular safety compared to ibuprofen or naproxen.","['patients with arthritis', 'arthritis patients with established CV disease', 'Arthritis Patients', '24,081 patients who required NSAIDs for osteoarthritis or rheumatoid arthritis and had increased CV risk randomly received', 'arthritis patients', 'practitioners managing individuals with chronic arthritis pain and high risk of impaired renal function and/or heart failure']","['Naproxen', 'naproxen', 'Inhibitor celecoxib', 'NSAIDs', 'celecoxib, ibuprofen or naproxen', 'celecoxib', 'Ibuprofen', 'ibuprofen', 'celecoxib, ibuprofen and naproxen', 'ibuprofen or naproxen', 'Celecoxib']","['favorable cardiovascular safety', 'renal events', 'intention-to-treat (ITT) population', 'incidence, severity and NSAID-related risk of the pre-specified composite cardiorenal outcome [adjudicated renal event, hospitalization for congestive heart failure (CHF), or hospitalization for hypertension (HTN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0263680', 'cui_str': 'Chronic arthritis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",24081.0,0.427102,"At the doses studied, celecoxib displayed fewer renal events and hence more favorable cardiovascular safety compared to ibuprofen or naproxen.","[{'ForeName': 'Slayman', 'Initials': 'S', 'LastName': 'Obeid', 'Affiliation': 'University Heart Center, Department of Cardiology, University Hospital Zurich.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Husni', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Qiuqing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Wisniewski', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Davey', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Wolski', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Weihang', 'Initials': 'W', 'LastName': 'Bao', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Walker', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ruschitzka', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Lüscher', 'Affiliation': 'Royal Brompton & Harefield Hospitals Trust and Imperial College, London, United Kingdom.'}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvac015']
2939,35234828,Effectiveness of Predominantly Group Schema Therapy and Combined Individual and Group Schema Therapy for Borderline Personality Disorder: A Randomized Clinical Trial.,"Importance


Schema therapy (ST), delivered either in an individual or group format, has been compared with other active treatments for borderline personality disorder (BPD). To our knowledge, the 2 formats have not been compared with treatment as usual (TAU) or with each other. Such comparisons help determine best treatment practices.
Objective


To evaluate whether ST is more effectively delivered in a predominantly group or combined individual and group format and whether ST is more effective than optimal TAU for BPD.
Design, Setting, and Participants


In this multicenter, 3-arm randomized clinical trial conducted at 15 sites in 5 countries (Australia, Germany, Greece, the Netherlands, and the UK), outpatients aged 18 to 65 years who had BPD were recruited between June 29, 2010, and May 18, 2016, to receive either predominantly group ST (PGST), combined individual and group ST (IGST), or optimal TAU. Data were analyzed from June 4, 2019, to December 29, 2021.
Interventions


At each site, cohorts of 16 to 18 participants were randomized 1:1 to PGST vs TAU or IGST vs TAU. Both ST formats were delivered over 2 years, with 2 sessions per week in year 1 and the frequency gradually decreasing during year 2. Assessments were collected by blinded assessors.
Main Outcomes and Measures


The primary outcome was the change in BPD severity over time, assessed with the Borderline Personality Disorder Severity Index (BPDSI) total score. Treatment retention was analyzed as a secondary outcome using generalized linear mixed model survival analysis.
Results


Of 495 participants (mean [SD] age, 33.6 [9.4] years; 426 [86.2%] female), 246 (49.7%) received TAU, 125 (25.2%) received PGST, and 124 (25.0%) received IGST (1 of whom later withdrew consent). PGST and IGST combined were superior to TAU with regard to reduced BPD severity (Cohen d, 0.73; 95% CI, 0.29-1.18; P < .001). For this outcome, IGST was superior to TAU (Cohen d, 1.14; 95% CI, 0.57-1.71; P < .001) and PGST (Cohen d, 0.84; 95% CI, 0.09-1.59; P = .03), whereas PGST did not differ significantly from TAU (Cohen d, 0.30; 95% CI, -0.29 to 0.89; P = .32). Treatment retention was greater in the IGST arm than in the PGST (1 year: 0.82 vs 0.72; 2 years: 0.74 vs. 0.62) and TAU (1 year: 0.82 vs 0.73; 2 years: 0.74 vs 0.64) arms, and there was no significant difference between the TAU and PGST arms (1 year: 0.73 vs 0.72; 2 years: 0.64 vs 0.62).
Conclusions and Relevance


In this randomized clinical trial, IGST was more effective and had greater treatment retention compared with TAU and PGST. These findings suggest that IGST is the preferred ST format, with high retention and continuation of improvement in BPD severity after the completion of treatment.
Trial Registration


trialregister.nl Identifier: NTR2392.",2022,"PGST and IGST combined were superior to TAU with regard to reduced BPD severity (Cohen d, 0.73; 95% CI, 0.29-1.18; P < .001).","['Borderline Personality Disorder', '15 sites in 5 countries (Australia, Germany, Greece, the Netherlands, and the UK), outpatients aged 18 to 65 years who had BPD were recruited between June 29, 2010, and May 18, 2016, to', '495 participants (mean [SD] age']","['Importance\n\n\nSchema therapy (ST', 'PGST and IGST', 'PGST', 'receive either predominantly group ST (PGST), combined individual and group ST (IGST), or optimal TAU', 'TAU', 'PGST vs TAU or IGST vs TAU', 'Combined Individual and Group Schema Therapy', 'ST', 'IGST']","['Treatment retention', 'PGST', 'change in BPD severity over time, assessed with the Borderline Personality Disorder Severity Index (BPDSI) total score', 'BPD severity']","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C5200813', 'cui_str': 'Schema Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",18.0,0.299557,"PGST and IGST combined were superior to TAU with regard to reduced BPD severity (Cohen d, 0.73; 95% CI, 0.29-1.18; P < .001).","[{'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': 'Arntz', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Gitta A', 'Initials': 'GA', 'LastName': 'Jacob', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute for Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Lee', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Odette Manon', 'Initials': 'OM', 'LastName': 'Brand-de Wilde', 'Affiliation': 'De Viersprong, the Netherlands Institute for Personality Disorders, Halsteren, the Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fassbinder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'R Patrick', 'Initials': 'RP', 'LastName': 'Harper', 'Affiliation': 'Bradford District Care NHS Foundation Trust, Bradford, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lavender', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Lockwood', 'Affiliation': 'Schema Therapy Institute Midwest, Kalamazoo, Michigan.'}, {'ForeName': 'Ioannis A', 'Initials': 'IA', 'LastName': 'Malogiannis', 'Affiliation': 'First Department of Psychiatry, Eginition Hospital, Medical School, Athens University, Athens, Greece.'}, {'ForeName': 'Florian A', 'Initials': 'FA', 'LastName': 'Ruths', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schweiger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Ida A', 'Initials': 'IA', 'LastName': 'Shaw', 'Affiliation': 'Schema Therapy Institute Midwest, Indianapolis, Indiana.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Zarbock', 'Affiliation': 'Institut für Verhaltenstherapie Ausbildung Hamburg GmbH (Institute for Training in Cognitive Behavioral Therapy), Hamburg, Germany.'}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Farrell', 'Affiliation': 'Schema Therapy Institute Midwest, Indianapolis, Indiana.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2022.0010']
2940,35234821,Comparison of Clopidogrel Monotherapy After 1 to 2 Months of Dual Antiplatelet Therapy With 12 Months of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome: The STOPDAPT-2 ACS Randomized Clinical Trial.,"Importance


Clopidogrel monotherapy after short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) has not yet been fully investigated in patients with acute coronary syndrome (ACS).
Objective


To test the hypothesis of noninferiority of 1 to 2 months of DAPT compared with 12 months of DAPT for a composite end point of cardiovascular and bleeding events in patients with ACS.
Design, Setting, and Participants


This multicenter, open-label, randomized clinical trial enrolled 4169 patients with ACS who underwent successful PCI using cobalt-chromium everolimus-eluting stents at 96 centers in Japan from December 2015 through June 2020. These data were analyzed from June to July 2021.
Interventions


Patients were randomized either to 1 to 2 months of DAPT followed by clopidogrel monotherapy (n = 2078) or to 12 months of DAPT with aspirin and clopidogrel (n = 2091).
Main Outcomes and Measures


The primary end point was a composite of cardiovascular (cardiovascular death, myocardial infarction [MI], any stroke, or definite stent thrombosis) or bleeding (Thrombolysis in MI major or minor bleeding) events at 12 months, with a noninferiority margin of 50% on the hazard ratio (HR) scale. The major secondary end points were cardiovascular and bleeding components of the primary end point.
Results


Among 4169 randomized patients, 33 withdrew consent. Of the 4136 included patients, the mean (SD) age was 66.8 (11.9) years, and 856 (21%) were women, 2324 (56%) had ST-segment elevation MI, and 826 (20%) had non-ST-segment elevation MI. A total of 4107 patients (99.3%) completed the 1-year follow-up in June 2021. One to 2 months of DAPT was not noninferior to 12 months of DAPT for the primary end point, which occurred in 65 of 2058 patients (3.2%) in the 1- to 2-month DAPT group and in 58 of 2057 patients (2.8%) in the 12-month DAPT group (absolute difference, 0.37% [95% CI, -0.68% to 1.42%]; HR, 1.14 [95% CI, 0.80-1.62]; P for noninferiority = .06). The major secondary cardiovascular end point occurred in 56 patients (2.8%) in the 1- to 2-month DAPT group and in 38 patients (1.9%) in the 12-month DAPT group (absolute difference, 0.90% [95% CI, -0.02% to 1.82%]; HR, 1.50 [95% CI, 0.99-2.26]). The major secondary bleeding end point occurred in 11 patients (0.5%) in the 1- to 2-month DAPT group and 24 patients (1.2%) in the 12-month DAPT group (absolute difference, -0.63% [95% CI, -1.20% to -0.06%]; HR, 0.46 [95% CI, 0.23-0.94]).
Conclusions and Relevance


In patients with ACS with successful PCI, clopidogrel monotherapy after 1 to 2 months of DAPT failed to attest noninferiority to standard 12 months of DAPT for the net clinical benefit with a numerical increase in cardiovascular events despite reduction in bleeding events. The directionally different efficacy and safety outcomes indicate the need for further clinical trials.
Trial Registration


ClinicalTrials.gov Identifiers: NCT02619760 and NCT03462498.",2022,"One to 2 months of DAPT was not noninferior to 12 months of DAPT for the primary end point, which occurred in 65 of 2058 patients (3.2%) in the 1- to 2-month DAPT group and in 58 of 2057 patients (2.8%) in the 12-month DAPT group (absolute difference, 0.37% [95% CI, -0.68% to 1.42%]; HR, 1.14 [95% CI, 0.80-1.62]; P for noninferiority = .06).","['patients with ACS', 'Of the 4136 included patients, the mean (SD) age was 66.8 (11.9) years, and 856 (21%) were women, 2324 (56%) had ST-segment elevation MI, and 826 (20%) had non-ST-segment elevation MI', 'patients with acute coronary syndrome (ACS', '4169 patients with ACS who underwent successful PCI using cobalt-chromium everolimus-eluting stents at 96 centers in Japan from December 2015 through June 2020', 'Patients With Acute Coronary Syndrome', 'A total of 4107 patients (99.3%) completed the 1-year follow-up in June 2021', '4169 randomized patients, 33 withdrew consent']","['DAPT', 'DAPT with aspirin and clopidogrel', 'DAPT followed by clopidogrel monotherapy', 'Clopidogrel Monotherapy', 'percutaneous coronary intervention (PCI', 'Dual Antiplatelet Therapy']","['cardiovascular and bleeding events', 'cardiovascular and bleeding components of the primary end point', 'composite of cardiovascular (cardiovascular death, myocardial infarction [MI], any stroke, or definite stent thrombosis) or bleeding (Thrombolysis in MI major or minor bleeding) events', 'hazard ratio (HR) scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517894', 'cui_str': '856'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",4169.0,0.209209,"One to 2 months of DAPT was not noninferior to 12 months of DAPT for the primary end point, which occurred in 65 of 2058 patients (3.2%) in the 1- to 2-month DAPT group and in 58 of 2057 patients (2.8%) in the 12-month DAPT group (absolute difference, 0.37% [95% CI, -0.68% to 1.42%]; HR, 1.14 [95% CI, 0.80-1.62]; P for noninferiority = .06).","[{'ForeName': 'Hirotoshi', 'Initials': 'H', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Natsuaki', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Obayashi', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Ogita', 'Affiliation': 'Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Suwa', 'Affiliation': 'Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Isawa', 'Affiliation': 'Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Takenori', 'Initials': 'T', 'LastName': 'Domei', 'Affiliation': 'Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan.'}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Yamaji', 'Affiliation': 'Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan.'}, {'ForeName': 'Shojiro', 'Initials': 'S', 'LastName': 'Tatsushima', 'Affiliation': 'Department of Cardiology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan.'}, {'ForeName': 'Masanobu', 'Initials': 'M', 'LastName': 'Ohya', 'Affiliation': 'Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Tokuyama', 'Affiliation': 'Department of Cardiology, Kawaguchi Cardiovascular and Respiratory Hospital, Kawaguchi, Japan.'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Tada', 'Affiliation': 'Department of Cardiology, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Cardiology, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Mori', 'Affiliation': 'Showa University Fujigaoka Hospital, Yokohama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Showa University Fujigaoka Hospital, Yokohama, Japan.'}, {'ForeName': 'Tenjin', 'Initials': 'T', 'LastName': 'Nishikura', 'Affiliation': 'Showa University Koto Toyosu Hospital, Tokyo, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Wakabayashi', 'Affiliation': 'Showa University Koto Toyosu Hospital, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hibi', 'Affiliation': 'Department of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Abe', 'Affiliation': 'Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Kawai', 'Affiliation': 'Department of Cardiology, Chikamori Hospital, Kochi, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakao', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ikari', 'Affiliation': 'Department of Cardiology, Tokai University Hospital, Isehara, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Morino', 'Affiliation': 'Department of Cardiology, Iwate Medical University Hospital, Morioka, Japan.'}, {'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Kadota', 'Affiliation': 'Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Furukawa', 'Affiliation': 'Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Cardiovascular Medicine, Shiga University of Medical Science, Otsu, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2021.5244']
2941,35234822,Do Not Rule Out Double-blind Placebo Run-in Periods for Randomized Clinical Trials.,,2022,,[],['Placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.801684,,"[{'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Targum', 'Affiliation': 'Signant Health, Boston, Massachusetts.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2022.0048']
2942,35235198,Effect of long-term aggressive nutrition therapy on survival in patients with alcohol-related cirrhosis: A randomized controlled trial.,"BACKGROUND


The aim of this study was to assess the effect of long-term aggressive nutritional therapy on clinical outcomes and survival in patients with alcoholic liver cirrhosis (ALC).
METHODS


Malnourished patients assessed by Royal Free Hospital-Subjective Global Assessment (RFH-SGA) were randomized to control group (CG) (35-40 kcal and 1.2 g protein/kg/day; diet alone) or intervention group (IG) (40-45 kcal and 1.5 g protein/kg/day; diet plus polymeric formula) for 3 months. Patients were followed up at 3 and 12 months.
RESULTS


Malnourished patients (age 44.0 ± 9 years; M [100%]; Child A:B:C [%] = 11:39:50) were randomized to the CG (n = 50) or IG (n = 54); 21 patients in CG and 27 in IG completed 3 months of follow-up. The RFH-SGA improved in 7 (33.3%; p = 0.016) in IG vs. 3 (14.2%; p = 0.625) in CG. Over 3 months, increments (CG vs. IG) were seen in calories (1554 ± 972 to 1823 ± 398; p = 0.001 vs.1542 ± 603 to 2254 ± 372; p=0.001), protein (53.1 ± 18.4 to 72.5 ± 19.6; p = 0.001 vs. 53 ± 21 to 86.9 ± 18.8; p = 0.00), dry body weight (64 ± 10 to 66 ± 11; p = 0.04 vs. 60.8 ± 9.2 to 63.2 ± 10.7; p = 0.009), and mid-upper arm circumference (MUAC) (24.7 ± 3.3 to 25.5 ± 3.3; p = 0.116 vs. 23.5 ± 2.7 to 24.1 ± 2.9; p = 0.015), with better ascites resolution in IG (53.3%; p = 0.008) vs. CG (44.4%; p = 0.227). Median 12-month survival was comparable in both the groups (p = 0.864). Irrespective of the intervention group, energy intake > 25 kcal and protein > 0.8 g/kg/day significantly improved 12-month survival.
CONCLUSION


Aggressive nutritional therapy improves nutritional status and resolves ascites, however fails to show long-term survival benefit, though higher calorie and protein intake has the potential to impact survival.
TRIAL REGISTRATION


NCT02140294.",2022,The RFH-SGA improved in 7 (33.3%; p = 0.016) in IG vs. 3 (14.2%; p = 0.625) in CG.,"['Malnourished patients (age 44.0 ± 9 years; M [100%]; Child A', 'patients with alcohol-related cirrhosis', 'patients with alcoholic liver cirrhosis (ALC', 'Malnourished patients assessed by Royal Free Hospital-Subjective Global Assessment (RFH-SGA']","['long-term aggressive nutrition therapy', 'control group (CG) (35-40 kcal and 1.2 g protein/kg/day; diet alone) or intervention group (IG', 'long-term aggressive nutritional therapy', 'CG', 'Aggressive nutritional therapy']","['RFH-SGA', 'dry body weight', '12-month survival', 'nutritional status and resolves ascites', 'survival', 'Median 12-month survival']","[{'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0023891', 'cui_str': 'Alcoholic cirrhosis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C0439418', 'cui_str': 'kg/day'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.104505,The RFH-SGA improved in 7 (33.3%; p = 0.016) in IG vs. 3 (14.2%; p = 0.625) in CG.,"[{'ForeName': 'Chetan', 'Initials': 'C', 'LastName': 'Kalal', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi, 110 070, India.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Benjamin', 'Affiliation': 'Department of Clinical Nutrition, Institute of Liver and Biliary Sciences, New Delhi, 110 070, India.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Shasthry', 'Affiliation': 'Department of Clinical Nutrition, Institute of Liver and Biliary Sciences, New Delhi, 110 070, India.'}, {'ForeName': 'Guresh', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, 110 070, India.'}, {'ForeName': 'Manoj Kumar', 'Initials': 'MK', 'LastName': 'Sharma', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi, 110 070, India.'}, {'ForeName': 'Yogendra Kumar', 'Initials': 'YK', 'LastName': 'Joshi', 'Affiliation': 'Department of Clinical Nutrition, Institute of Liver and Biliary Sciences, New Delhi, 110 070, India.'}, {'ForeName': 'Shiv Kumar', 'Initials': 'SK', 'LastName': 'Sarin', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi, 110 070, India. shivsarin@gmail.com.'}]",Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology,['10.1007/s12664-021-01187-3']
2943,35235197,"Biofeedback, biofeedback plus fiber laxative, and biofeedback plus osmotic laxative regimens to treat constipation in patients with pelvic floor dyssynergia: A randomized controlled trial.","BACKGROUND


Pelvic floor dyssynergia (PFD) is one of the causes of chronic constipation. Laxative-based therapies are not very effective in treating this type of constipation. The therapeutic effectiveness of three therapeutic strategies, including biofeedback (BOF) alone, BOF+ fiber laxative (psyllium), and BOF +osmotic laxative (polyethylene glycol; [PEG]), was assessed in patients with constipation secondary to PFD.
METHODS


Eighty-eight patients with constipation were included during a period from 2017 to 2018. Thirty-two patients were treated with BOF alone, 25 patients received BOF+ fiber laxative (psyllium), and 31 patients received BOF+ osmotic laxative (PEG) for 2 to 3 months. A checklist was used to compare outcomes before and after the interventions.
RESULTS


Satisfaction rates from the treatments were 60.83%, 46.88%, and 41.32% in the BOF, BOF + psyllium, and BOF + PEG groups, respectively. Women had a higher satisfaction rate compared to men. Defecation quality improved, and the frequency of enema usage decreased (p <0.05) in all the groups after intervention. Difficulty in evacuation, need for digitation, and return to the toilet after defecation significantly improved in the BOF alone group. Using laxatives reduced straining during evacuation and increased the duration of defecation. All the three regimens reduced rectal bleeding (p <0.05).
CONCLUSIONS


Combinations of laxatives with BOF did not offer significant therapeutic benefit. As laxatives may cause dissatisfaction and incomplete/prolonged defecations in patients with PFD, adding laxatives to the BOF regimen is not recommended for these patients.",2022,"All the three regimens reduced rectal bleeding (p <0.05).
","['Eighty-eight patients with constipation were included during a period\xa0from 2017 to 2018', 'patients with constipation secondary to PFD', 'patients with PFD', 'patients with pelvic floor dyssynergia']","['BOF+ fiber laxative (psyllium', 'Biofeedback, biofeedback plus fiber laxative, and biofeedback plus osmotic laxative regimens', 'biofeedback (BOF) alone, BOF+ fiber laxative (psyllium), and BOF +osmotic laxative (polyethylene glycol; [PEG', 'BOF alone', 'Laxative-based therapies', 'BOF+ osmotic laxative (PEG']","['satisfaction rate', 'rectal bleeding', 'Defecation quality', 'frequency of enema usage', 'Difficulty in evacuation, need for digitation, and return to the toilet after defecation', 'Satisfaction rates', 'duration of defecation']","[{'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C1535943', 'cui_str': 'Pelvic floor dyssynergia'}]","[{'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}, {'cui': 'C0033979', 'cui_str': 'Psyllium'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0029391', 'cui_str': 'Osmosis'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0014268', 'cui_str': 'Giving patient an enema'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0184958', 'cui_str': 'Toilet'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",32.0,0.0368973,"All the three regimens reduced rectal bleeding (p <0.05).
","[{'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Jamshidi', 'Affiliation': 'Internal Medicine Department, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Malekpour', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran. habib.malekpour@gmail.com.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Abdi', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Faranak', 'Initials': 'F', 'LastName': 'Farhan', 'Affiliation': 'Research Institute for Gastroenterology and Liver Disease, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology,['10.1007/s12664-021-01189-1']
2944,35235142,Effects of Smoking Reduction and Cessation on Birth Outcomes in a Scheduled Gradual Reduction Cessation Trial.,"INTRODUCTION


Smoking during pregnancy can affect infant birthweight. We tested whether an intervention that promoted scheduled gradual reduction improved birth outcomes among pregnant women who smoked. We also examined race differences in birth outcomes.
METHODS


We conducted a 2-arm randomized controlled trial where pregnant women who smoked received either SMS text-delivered scheduled gradual smoking reduction (SGR) program plus support texts or support messages only throughout their pregnancy. The outcomes for this paper were birth outcomes including birth weight and gestational age obtained from chart review. Analyses were conducted using chi-square and t-tests in SAS.
RESULTS


We approached 2201 pregnant women with smoking history. Of the 314 women recruited into the study, 290 completed a medical release form (92%). We did not find any significant differences in birth outcomes by arm or race. The majority of participants reduced smoking by the 80%. Women who reduced more than 50% of their baseline cigarettes per day had a birth weight increase of 335 g compared to those that did not (p = 0.05). The presence of alcohol/drug use in prenatal visit notes was associated with low infant birth weight (p = 0.05).
DISCUSSION


The scheduled gradual reduction intervention did not improve birth outcomes. Additional research is needed to help improve birth outcomes for pregnant women who engage in tobacco and illicit substance use. CLINICAL TRIAL #: NCT01995097.",2022,"The presence of alcohol/drug use in prenatal visit notes was associated with low infant birth weight (p = 0.05).
","['2201 pregnant women with smoking history', 'pregnant women who smoked received either', 'pregnant women who engage in tobacco and illicit substance use', '314 women recruited into the study, 290 completed a medical release form (92', 'pregnant women who smoked']","['Smoking Reduction and Cessation', 'SMS text-delivered scheduled gradual smoking reduction (SGR) program plus support texts or support messages']","['birth weight increase', 'low infant birth weight', 'Birth Outcomes', 'birth weight and gestational age obtained from chart review', 'birth outcomes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0281875', 'cui_str': 'Illicit medication use'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0541653', 'cui_str': 'Chart evaluation by healthcare professional'}]",2201.0,0.211665,"The presence of alcohol/drug use in prenatal visit notes was associated with low infant birth weight (p = 0.05).
","[{'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Kennedy', 'Affiliation': 'Cancer Prevention and Control, Duke Cancer Institute, Durham, NC, 2771, USA. daniellelkenn@gmail.com.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Lyna', 'Affiliation': 'Cancer Prevention and Control, Duke Cancer Institute, Durham, NC, 2771, USA.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Cancer Prevention and Control, Duke Cancer Institute, Durham, NC, 2771, USA.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Noonan', 'Affiliation': 'Cancer Prevention and Control, Duke Cancer Institute, Durham, NC, 2771, USA.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Bejarano Hernandez', 'Affiliation': 'Doctor of Medicine Program, University of North Carolina, Chapel Hill, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Fish', 'Affiliation': 'Cancer Prevention and Control, Duke Cancer Institute, Durham, NC, 2771, USA.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Department of Obstetrics and Gynecology, DUMC 3083, Durham, USA.'}, {'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Prevention and Control, Duke Cancer Institute, Durham, NC, 2771, USA.'}]",Maternal and child health journal,['10.1007/s10995-022-03386-6']
2945,35235092,Effects of Cannabidiol on Exercise Physiology and Bioenergetics: A Randomised Controlled Pilot Trial.,"BACKGROUND


Cannabidiol (CBD) has demonstrated anti-inflammatory, analgesic, anxiolytic and neuroprotective effects that have the potential to benefit athletes. This pilot study investigated the effects of acute, oral CBD treatment on physiological and psychological responses to aerobic exercise to determine its practical utility within the sporting context.
METHODS


On two occasions, nine endurance-trained males (mean ± SD V̇O 2max : 57.4 ± 4.0 mL·min -1 ·kg -1 ) ran for 60 min at a fixed intensity (70% V̇O 2max ) (RUN 1) before completing an incremental run to exhaustion (RUN 2). Participants received CBD (300 mg; oral) or placebo 1.5 h before exercise in a randomised, double-blind design. Respiratory gases (V̇O 2 ), respiratory exchange ratio (RER), heart rate (HR), blood glucose (BG) and lactate (BL) concentrations, and ratings of perceived exertion (RPE) and pleasure-displeasure were measured at three timepoints (T1-3) during RUN 1. V̇O 2max , RER max , HR max  and time to exhaustion (TTE) were recorded during RUN 2. Venous blood was drawn at Baseline, Pre- and Post-RUN 1, Post-RUN 2 and 1 h Post-RUN 2. Data were synthesised using Cohen's d z  effect sizes and 85% confidence intervals (CIs). Effects were considered worthy of further investigation if the 85% CI included ± 0.5 but not zero.
RESULTS


CBD appeared to increase V̇O 2  (T2: + 38 ± 48 mL·min -1 , d z : 0.25-1.35), ratings of pleasure (T1: + 0.7 ± 0.9, d z : 0.22-1.32; T2: + 0.8 ± 1.1, d z : 0.17-1.25) and BL (T2: + 3.3 ± 6.4 mmol·L -1 , d z : > 0.00-1.03) during RUN 1 compared to placebo. No differences in HR, RPE, BG or RER were observed between treatments. CBD appeared to increase V̇O 2max  (+ 119 ± 206 mL·min -1 , d z : 0.06-1.10) and RER max  (+ 0.04 ± 0.05 d z : 0.24-1.34) during RUN 2 compared to placebo. No differences in TTE or HR max  were observed between treatments. Exercise increased serum interleukin (IL)-6, IL-1β, tumour necrosis factor-α, lipopolysaccharide and myoglobin concentrations (i.e. Baseline vs. Post-RUN 1, Post-RUN 2 and/or 1-h Post-RUN 2, p's < 0.05). However, the changes were small, making it difficult to reliably evaluate the effect of CBD, where an effect appeared to be present. Plasma concentrations of the endogenous cannabinoid, anandamide (AEA), increased Post-RUN 1 and Post-RUN 2, relative to Baseline and Pre-RUN 1 (p's < 0.05). CBD appeared to reduce AEA concentrations Post-RUN 2, compared to placebo (- 0.95 ± 0.64 pmol·mL -1 , d z : - 2.19, - 0.79).
CONCLUSION


CBD appears to alter some key physiological and psychological responses to aerobic exercise without impairing performance. Larger studies are required to confirm and better understand these preliminary findings. Trial Registration This investigation was approved by the Sydney Local Health District's Human Research Ethics Committee (2020/ETH00226) and registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12620000941965).",2022,"Exercise increased serum interleukin (IL)-6, IL-1β, tumour necrosis factor-α, lipopolysaccharide and myoglobin concentrations (i.e. Baseline vs. Post-RUN 1, Post-RUN 2 and/or 1-h Post-RUN 2, p's < 0.05).","[""Sydney Local Health District's Human Research Ethics Committee (2020/ETH00226) and registered with the Australia and New Zealand Clinical Trials Registry"", 'nine endurance-trained males (mean\u2009±\u2009SD V̇O 2max : 57.4\u2009±\u20094.0\xa0mL·min -1 ·kg -1 ) ran for 60\xa0min at a fixed intensity (70% V̇O 2max ']","['CBD', 'Cannabidiol', 'placebo 1.5\xa0h before exercise', 'placebo']","['ratings of pleasure', 'increase V̇O 2max', 'CBD', 'Exercise Physiology and Bioenergetics', 'V̇O 2max , RER max , HR max \xa0and time to exhaustion (TTE', 'TTE or HR max', 'Venous blood', 'Respiratory gases (V̇O 2 ), respiratory exchange ratio (RER), heart rate (HR), blood glucose (BG) and lactate (BL) concentrations, and ratings of perceived exertion (RPE) and pleasure-displeasure', 'serum interleukin (IL)-6, IL-1β, tumour necrosis factor-α, lipopolysaccharide and myoglobin concentrations', 'AEA concentrations', 'Plasma concentrations of the endogenous cannabinoid, anandamide (AEA', 'HR, RPE, BG or RER']","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0585043', 'cui_str': 'Before exercise'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0005486', 'cui_str': 'Bioenergetics'}, {'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",,0.16955,"Exercise increased serum interleukin (IL)-6, IL-1β, tumour necrosis factor-α, lipopolysaccharide and myoglobin concentrations (i.e. Baseline vs. Post-RUN 1, Post-RUN 2 and/or 1-h Post-RUN 2, p's < 0.05).","[{'ForeName': 'Ayshe', 'Initials': 'A', 'LastName': 'Sahinovic', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, NSW, Australia. ayshe.sahinovic@sydney.edu.au.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Irwin', 'Affiliation': 'School of Health Sciences and Social Work, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Doohan', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Kevin', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Cox', 'Affiliation': 'School of Medical Science, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Namson S', 'Initials': 'NS', 'LastName': 'Lau', 'Affiliation': 'South West Clinical School, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Desbrow', 'Affiliation': 'School of Health Sciences and Social Work, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Sabag', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Sydney, NSW, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hislop', 'Affiliation': 'Brisbane Sport and Exercise Medicine Specialists, Brisbane, QLD, Australia.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Haber', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Iain S', 'Initials': 'IS', 'LastName': 'McGregor', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McCartney', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, NSW, Australia.'}]",Sports medicine - open,['10.1186/s40798-022-00417-y']
2946,35235082,Effects of light-emitting diode therapy on cardiovascular and salivary nitrite responses in postmenopausal women submitted to a single bout of high-intensity interval training.,"The aim of the present study was to analyze the effects of light-emitting diode therapy (LEDT) on cardiovascular effort during a single bout of high-intensity interval training (HIIT) and on blood pressure (BP), salivary nitrite, and heart rate variability (HRV) responses after the exercise session in postmenopausal women. Sixteen postmenopausal women between 50 and 70 years of age participated in the present study. The intervention comprised two sessions: placebo plus HIIT and LEDT plus HIIT, with a 14-day interval between sessions. The oxygen uptake (VO 2 ), heart rate (HR), and rating of perceived exertion (RPE) were monitored throughout the HIIT sessions. Salivary samples were taken before, immediately post, and 30' and 60' post-HIIT sessions for nitric oxide (NO) analysis. In addition, HR and BP were checked before, 15 min, 30 min, 45 min, and 60 min post-HIIT sessions. HR data were used to calculate the HRV indices. Cardiovascular parameters during HIIT and BP, HRV, and NO responses were not different between placebo and LEDT conditions (p > 0.05). BP responses increased after compared to pre-exercise (p < 0.01). HRV was impaired post- compared to pre-exercise (p < 0.05). LEDT did not improve physiological performance during HIIT and did not accelerate the recovery of BP and autonomic modulation or change the NO release after exercise in postmenopausal women.",2022,LEDT did not improve physiological performance during HIIT and did not accelerate the recovery of BP and autonomic modulation or change the NO release after exercise in postmenopausal women.,"['Sixteen postmenopausal women between 50 and 70\xa0years of age participated in the present study', 'postmenopausal women', 'postmenopausal women submitted to a single bout of high-intensity interval training']","['light-emitting diode therapy', 'LEDT', 'light-emitting diode therapy (LEDT', 'placebo plus HIIT and LEDT plus HIIT']","['Cardiovascular parameters during HIIT and BP, HRV, and NO responses', 'blood pressure (BP), salivary nitrite, and heart rate variability (HRV) responses', 'cardiovascular and salivary nitrite responses', 'oxygen uptake (VO 2 ), heart rate (HR), and rating of perceived exertion (RPE', 'HRV', 'recovery of BP and autonomic modulation', 'physiological performance', 'HR and BP', 'BP responses']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}]",16.0,0.0307543,LEDT did not improve physiological performance during HIIT and did not accelerate the recovery of BP and autonomic modulation or change the NO release after exercise in postmenopausal women.,"[{'ForeName': 'Victor Hugo', 'Initials': 'VH', 'LastName': 'de Freitas', 'Affiliation': 'Faculty of Physical Education, Federal University of Uberlandia, Rua Benjamin Constant, 1286, Bairro: Aparecida, MG, 38400-678, Uberlândia, Brazil.'}, {'ForeName': 'Igor Moraes', 'Initials': 'IM', 'LastName': 'Mariano', 'Affiliation': 'Faculty of Physical Education, Federal University of Uberlandia, Rua Benjamin Constant, 1286, Bairro: Aparecida, MG, 38400-678, Uberlândia, Brazil.'}, {'ForeName': 'Ana Luiza', 'Initials': 'AL', 'LastName': 'Amaral', 'Affiliation': 'Faculty of Physical Education, Federal University of Uberlandia, Rua Benjamin Constant, 1286, Bairro: Aparecida, MG, 38400-678, Uberlândia, Brazil.'}, {'ForeName': 'Mateus Lima', 'Initials': 'ML', 'LastName': 'Rodrigues', 'Affiliation': 'Faculty of Physical Education, Federal University of Uberlandia, Rua Benjamin Constant, 1286, Bairro: Aparecida, MG, 38400-678, Uberlândia, Brazil.'}, {'ForeName': 'Victor Hugo Vilarinho', 'Initials': 'VHV', 'LastName': 'Carrijo', 'Affiliation': 'Faculty of Physical Education, Federal University of Uberlandia, Rua Benjamin Constant, 1286, Bairro: Aparecida, MG, 38400-678, Uberlândia, Brazil.'}, {'ForeName': 'Guilherme Morais', 'Initials': 'GM', 'LastName': 'Puga', 'Affiliation': 'Faculty of Physical Education, Federal University of Uberlandia, Rua Benjamin Constant, 1286, Bairro: Aparecida, MG, 38400-678, Uberlândia, Brazil. gmpuga@gmail.com.'}]",Lasers in medical science,['10.1007/s10103-022-03533-z']
2947,34919682,Marginal Zinc Deficiency Alters Essential Fatty Acid Metabolism in Healthy Men.,"BACKGROUND


Rice biofortification with Zinc (Zn) can improve the Zn status of rice-consuming populations. However, the metabolic impact in humans consuming Zn-biofortified rice is unknown.
OBJECTIVES


To determine the effects of Zn-biofortified rice on lipid metabolism in normolipidemic men.
METHODS


The men consumed a rice-based diet containing 6 mg Zn/d and 1.5 g phytate (phytate/Zn ratio = 44) for 2 wk followed by a 10-mg Zn/d diet without phytate for 4 wk. An ad libitum diet supplemented with 25 mg Zn/d was then fed for 3 wk. Fasting blood samples were taken at baseline and at the end of each metabolic period for measuring plasma zinc, glucose, insulin, triglyceride (TG), LDL and HDL cholesterol, fatty acids, oxylipins, and fatty acid desaturase activities. Statistical differences were assessed by linear mixed model.
RESULTS


Fatty acid desaturase (FADS) 1 activity decreased by 29.1% (P = 0.007) when the 6-mg Zn/d diet was consumed for 2 wk. This change was associated with significant decreases in HDL and LDL cholesterol. The alterations in FADS1, HDL cholesterol, and TG remained unchanged when Zn intakes were increased to 10 mg/d for 4 wk. Supplementation with 25 mg Zn/d for 3 wk normalized these metabolic changes and significantly increased LDL cholesterol at the end of this metabolic period compared with baseline. FADS1 activity was inversely correlated with FADS2 (rmcorr = -0.52; P = 0.001) and TG (rmcorr = -0.55; P = 0.001) at all time points.
CONCLUSIONS


A low-zinc, high-phytate rice-based diet reduced plasma HDL cholesterol concentrations and altered fatty acid profiles in healthy men within 2 wk. Consuming 10 mg Zn/d without phytate for 4 wk did not improve the lipid profiles, but a 25-mg Zn/d supplement corrects these alterations in lipid metabolism within 3 wk.",2022,FADS1 activity was inversely correlated with FADS2,"['Healthy Men', 'normolipidemic men', 'healthy men within 2 wk']","['Zinc (Zn', 'Fatty acid desaturase (FADS', 'Zn-biofortified rice', 'FADS2']","['1 activity', 'plasma HDL cholesterol concentrations', 'HDL and LDL cholesterol', 'FADS1 activity', 'lipid metabolism', 'LDL cholesterol', 'plasma zinc, glucose, insulin, triglyceride (TG), LDL and HDL cholesterol, fatty acids, oxylipins, and fatty acid desaturase activities', 'Fasting blood samples', 'lipid profiles', 'FADS1, HDL cholesterol, and TG']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0015680', 'cui_str': 'Fatty Acid Desaturating Enzymes'}, {'cui': 'C0035567', 'cui_str': 'Rice'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1278148', 'cui_str': 'Plasma HDL cholesterol measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0015680', 'cui_str': 'Fatty Acid Desaturating Enzymes'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",44.0,0.23854,FADS1 activity was inversely correlated with FADS2,"[{'ForeName': 'Jung H', 'Initials': 'JH', 'LastName': 'Suh', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland Research Institute, Oakland, CA, USA.""}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Zyba', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland Research Institute, Oakland, CA, USA.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Shigenaga', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland Research Institute, Oakland, CA, USA.""}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'McDonald', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland Research Institute, Oakland, CA, USA.""}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'King', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland Research Institute, Oakland, CA, USA.""}]",The Journal of nutrition,['10.1093/jn/nxab425']
2948,34923134,Escitalopram modulates learning content-specific neuroplasticity of functional brain networks.,"Learning-induced neuroplastic changes, further modulated by content and setting, are mirrored in brain functional connectivity (FC). In animal models, selective serotonin reuptake inhibitors (SSRIs) have been shown to facilitate neuroplasticity. This is especially prominent during emotional relearning, such as fear extinction, which may translate to clinical improvements in patients. To investigate a comparable modulation of neuroplasticity in humans, 99 healthy subjects underwent three weeks of emotional (matching faces) or non-emotional learning (matching Chinese characters to unrelated German nouns). Shuffled pairings of the original content were subsequently relearned for the same time. During relearning, subjects received either a daily dose of the SSRI escitalopram or placebo. Resting-state functional magnetic resonance imaging was performed before and after the (re-)learning phases. FC changes in a network comprising Broca's area, the medial prefrontal cortex, the right inferior temporal and left lingual gyrus were modulated by escitalopram intake. More specifically, it increased the bidirectional connectivity between medial prefrontal cortex and lingual gyrus for non-emotional and the connectivity from medial prefrontal cortex to Broca's area for emotional relearning. The context dependence of these effects together with behavioral correlations supports the assumption that SSRIs in clinical practice improve neuroplasticity rather than psychiatric symptoms per se. Beyond expanding the complexities of learning, these findings emphasize the influence of external factors on human neuroplasticity.",2022,"FC changes in a network comprising Broca's area, the medial prefrontal cortex, the right inferior temporal and left lingual gyrus were modulated by escitalopram intake.","['humans, 99 healthy subjects underwent three weeks of']","['emotional (matching faces) or non-emotional learning (matching Chinese characters to unrelated German nouns', 'SSRI escitalopram or placebo']","['brain functional connectivity (FC', 'bidirectional connectivity']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0582589', 'cui_str': 'Emotional learning'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",99.0,0.0627189,"FC changes in a network comprising Broca's area, the medial prefrontal cortex, the right inferior temporal and left lingual gyrus were modulated by escitalopram intake.","[{'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Klöbl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Spitalgasse 23, Vienna 1090, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Seiger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Spitalgasse 23, Vienna 1090, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vanicek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Spitalgasse 23, Vienna 1090, Austria.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Handschuh', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Spitalgasse 23, Vienna 1090, Austria.'}, {'ForeName': 'Murray Bruce', 'Initials': 'MB', 'LastName': 'Reed', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Spitalgasse 23, Vienna 1090, Austria.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Spurny-Dworak', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Spitalgasse 23, Vienna 1090, Austria.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Ritter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Spitalgasse 23, Vienna 1090, Austria.'}, {'ForeName': 'Godber Mathis', 'Initials': 'GM', 'LastName': 'Godbersen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Spitalgasse 23, Vienna 1090, Austria.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Gryglewski', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Spitalgasse 23, Vienna 1090, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Spitalgasse 23, Vienna 1090, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Spitalgasse 23, Vienna 1090, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Lanzenberger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Spitalgasse 23, Vienna 1090, Austria. Electronic address: rupert.lanzenberger@meduniwien.ac.at.'}]",NeuroImage,['10.1016/j.neuroimage.2021.118829']
2949,34741460,Severe Hypoglycemia and Incident Heart Failure Among Adults With Type 2 Diabetes.,"CONTEXT


The association of severe hypoglycemia on the incidence of heart failure (HF) is unclear.
OBJECTIVE


We evaluated the association of severe hypoglycemia with incident HF among individuals with type 2 diabetes.
METHODS


We included participants with type 2 diabetes from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study. Severe hypoglycemia episodes were assessed during the initial 24 months following randomization and defined using 2 methods: (1) symptomatic, severe hypoglycemic event requiring medical assistance (first definition); or (2) requiring any assistance (second definition). Participants without HF at baseline and during the first 24 months of the study were prospectively followed for incident HF hospitalization. Multivariable Cox regression was used to generate adjusted hazard ratios (HR) for the association of severe hypoglycemia and incident HF.
RESULTS


Among 9208 participants (mean age 63 years, 38% female, 62% White), 365 had ≥ 1 episode of severe hypoglycemic. Over a median follow-up duration of 3 years, there were 249 incident HF events. After multivariable adjustment for relevant confounders, participants with severe hypoglycemia requiring medical assistance had a 68% higher relative risk of incident HF (HR 1.68; 95% CI, 1.06-2.66), as compared with individuals who never experienced any episode of hypoglycemia. Severe hypoglycemia requiring any assistance was also associated with a 49% higher relative risk of HF (HR 1.49; 95% CI, 1.01-2.21).
CONCLUSION


In a large cohort of adults with type 2 diabetes, severe hypoglycemia was independently associated with greater risk of incident HF.",2022,"Severe hypoglycemia requiring any assistance was also associated with a 49% higher relative risk of HF (HR 1.49; 95% CI, 1.01-2.21).
","['Adults With Type 2 Diabetes', 'individuals with type 2 diabetes', 'participants with type 2 diabetes from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study', '9208 participants (mean age 63 years, 38% female, 62% White), 365 had ≥ 1 episode of severe hypoglycemic']",[],"['severe hypoglycemia', 'Severe hypoglycemia episodes', 'Severe Hypoglycemia and Incident Heart Failure', 'episode of hypoglycemia', 'relative risk of incident HF', 'symptomatic, severe hypoglycemic event requiring medical assistance (first definition); or (2) requiring any assistance (second definition', 'Severe hypoglycemia requiring any assistance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}]",[],"[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0025070', 'cui_str': 'Assistance, Medical'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",9208.0,0.156115,"Severe hypoglycemia requiring any assistance was also associated with a 49% higher relative risk of HF (HR 1.49; 95% CI, 1.01-2.21).
","[{'ForeName': 'Justin B', 'Initials': 'JB', 'LastName': 'Echouffo-Tcheugui', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Diabetes & Metabolism, Johns Hopkins School of Medicine, Baltimore, MD 21224, USA.'}, {'ForeName': 'Arnaud D', 'Initials': 'AD', 'LastName': 'Kaze', 'Affiliation': 'Department of Medicine, SOVAH Health, Danville, VA 24541, USA.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan UCLA Medical Center, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of Tennessee Health Science Center, Memphis, TN 38163, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab794']
2950,34734262,Egg Consumption and Blood Lipid Parameters According to the Presence of Chronic Metabolic Disorders: The EVIDENT II Study.,"CONTEXT


Egg consumption is one of the main dietary sources of cholesterol, but whether individuals who eat more eggs have a worse blood lipid profile remains controversial.
OBJECTIVE


We examined the relationship between egg consumption and lipid parameters and explored whether this relationship changes according to the presence of chronic metabolic disorders.
METHODS


A multicenter cross-sectional study was conducted with adult participants in the EVIDENT II trial. Adjusted linear regression models were stratified by the main chronic metabolic disorders.
RESULTS


Among the 728 participants (61.9% women, mean age 52.1 ± 11.9 years), the mean egg consumption was equivalent to 5 to 6 eggs per week for a 70-kg individual. In the fully adjusted analysis, no association was found of egg consumption with total and high-density lipoprotein cholesterol (HDL-c), and triglyceride levels. Furthermore, compared with the first quartile of consumption, the fourth quartile was associated with lower low-density lipoprotein cholesterol (LDL-c) levels (coefficient -7.01; 95% CI -13.39, -0.62) and a lower LDL-c/HDL-c ratio (coefficient -0.24, 95% CI -0.41, -0.06). In the analyses stratified by chronic metabolic diseases, higher egg consumption was not associated with lipid profile in those with obesity, hypertension, type 2 diabetes, dyslipidemia, or treated with hypolipidemic drugs, and was associated with a better lipid profile in participants without these conditions.
CONCLUSION


Higher egg consumption was not associated with blood lipids in individuals with chronic metabolic disorders. In individuals without such conditions, the lipid profile was better among those who consumed more eggs. Our findings support current guidelines recommending eggs as part of a healthy diet.",2022,"In the analyses stratified by chronic metabolic diseases, higher egg consumption was not associated with lipid profile in those with obesity, hypertension, type 2 diabetes, dyslipidemia, or treated with hypolipidemic drugs, and was associated with a better lipid profile in participants without these conditions.
","['A multicenter cross-sectional study was conducted with adult participants in the EVIDENT II trial', '728 participants (61.9% women, mean age 52.1 ± 11.9 years', 'individuals with chronic metabolic disorders']",[],"['low-density lipoprotein cholesterol (LDL-c) levels', 'egg consumption with total and high-density lipoprotein cholesterol (HDL-c), and triglyceride levels', 'Egg Consumption and Blood Lipid Parameters', 'lipid profile', 'mean egg consumption', 'blood lipids']","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1263722', 'cui_str': 'Chronic metabolic disorder'}]",[],"[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",728.0,0.157692,"In the analyses stratified by chronic metabolic diseases, higher egg consumption was not associated with lipid profile in those with obesity, hypertension, type 2 diabetes, dyslipidemia, or treated with hypolipidemic drugs, and was associated with a better lipid profile in participants without these conditions.
","[{'ForeName': 'Arthur Eumann', 'Initials': 'AE', 'LastName': 'Mesas', 'Affiliation': 'Universidad de Castilla-La Mancha, Health and Social Research Center, Cuenca, 16071, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Garrido-Miguel', 'Affiliation': 'Universidad de Castilla-La Mancha, Health and Social Research Center, Cuenca, 16071, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Fernández-Rodríguez', 'Affiliation': 'Universidad de Castilla-La Mancha, Health and Social Research Center, Cuenca, 16071, Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Fernández Franco', 'Affiliation': 'Grupo Avícola Rujamar, San Lorenzo de la Parrilla, Cuenca, 16770, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lugones-Sánchez', 'Affiliation': 'Unidad de Investigación en Atención Primaria de Salamanca (APISAL), Instituto de investigación Biomédica de Salamanca (IBSAL), Gerencia de Atención Primaria de Salamanca, Gerencia Regional de Salud de Castilla y León (SACyL), Salamanca, 37005, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'García-Ortiz', 'Affiliation': 'Unidad de Investigación en Atención Primaria de Salamanca (APISAL), Instituto de investigación Biomédica de Salamanca (IBSAL), Gerencia de Atención Primaria de Salamanca, Gerencia Regional de Salud de Castilla y León (SACyL), Salamanca, 37005, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Martínez-Vizcaíno', 'Affiliation': 'Universidad de Castilla-La Mancha, Health and Social Research Center, Cuenca, 16071, Spain.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgab802']
2951,34855651,The association between nondipper pattern and perioperative hypertension in patients with controlled hypertension.,"BACKGROUND


Perioperative hypertension is a frequent complication even in preoperatively normotensive or controlled hypertensive patients and there is a lack of data regarding the effect of nondipping pattern on perioperative hypertension.
OBJECTIVE


In this study, we aimed to investigate the possible effect of nondipping blood pressure pattern on the risk of perioperative hypertension.
MATERIALS AND METHODS


234 hypertensive patients who underwent surgery with general anesthesia were evaluated prospectively. The study enrolled patients with well-controlled preoperative blood pressure. The 24-h ambulatory blood pressure monitoring results were used to classify patients as dippers and nondippers. Perioperative hypertension is defined as a systolic/diastolic arterial blood pressure greater than or equal to 160/90 mmHg or systolic blood pressure elevated by more than 20% from the patient's baseline level for more than 15 min perioperatively.
RESULTS


There were 61 (26%) nondipper patients [mean age: 62.1 ± 7.1 years, 25 (40.9%) men] and 173 (74%) dipper patients [mean age: 61.4 ± 8.1 years, 83 (47.9%) men]. In the nondipper group, perioperative hypertension was observed in 31 (51.3%) patients, whereas in the dipper group, 33 (19.3%) patients experienced a hypertensive attack (P < 0.001). The independent predictors of perioperative hypertension were the presence of the nondipping pattern [odds ratio (OR) 3.084; 95% confidence interval (CI) 1.831-5.195; P < 0.001], the presence of diabetes mellitus (OR 2.059; 95% CI 1.215-3.490; P = 0.007), and the number of drugs (OR 2.317; 95% CI 1.102-5.097; P = 0.027).
CONCLUSION


The frequency of perioperative hypertension was higher in preoperative normotensive and known hypertensive patients who were identified as nondippers. In addition, diabetes mellitus and number of drugs were found to be predictors of perioperative hypertension.",2022,The frequency of perioperative hypertension was higher in preoperative normotensive and known hypertensive patients who were identified as nondippers.,"['patients with controlled hypertension', 'preoperatively normotensive or controlled hypertensive patients', 'There were 61 (26%) nondipper patients [mean age: 62.1 ± 7.1 years, 25 (40.9%) men] and 173 (74%) dipper patients [mean age: 61.4 ± 8.1 years, 83 (47.9%) men', 'enrolled patients with well-controlled preoperative blood pressure', '234 hypertensive patients who underwent surgery with general anesthesia were evaluated prospectively']",['nondipping blood pressure pattern'],"['Perioperative hypertension', 'presence of diabetes mellitus', '24-h ambulatory blood pressure monitoring', 'hypertensive attack', 'perioperative hypertension', 'frequency of perioperative hypertension', 'systolic/diastolic arterial blood pressure', 'systolic blood pressure elevated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0326560', 'cui_str': 'Cinclidae'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C3661921', 'cui_str': 'Perioperative hypertension'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}]",234.0,0.0443211,The frequency of perioperative hypertension was higher in preoperative normotensive and known hypertensive patients who were identified as nondippers.,"[{'ForeName': 'Güney', 'Initials': 'G', 'LastName': 'Erdoğan', 'Affiliation': 'Department of Cardiology, Samsun Training and Research Hospital, Samsun University Faculty of Medicine, Samsun.'}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Arslan', 'Affiliation': 'Department of Cardiology, Samsun Training and Research Hospital, Samsun University Faculty of Medicine, Samsun.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Yenerçağ', 'Affiliation': 'Department of Cardiology, Training and Research Hospital, Ordu University, Ordu.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Şahin', 'Affiliation': 'Department of Cardiology, Konya Seydisehir State Hospital, Konya.'}, {'ForeName': 'Hande', 'Initials': 'H', 'LastName': 'Arslan', 'Affiliation': 'Department of Otorhinolaryngology, Ankara Dişkapi Training and Research Hospital, University of Health Sciences, Ankara.'}, {'ForeName': 'Mustafa Baran', 'Initials': 'MB', 'LastName': 'Yavuz', 'Affiliation': 'Department of Anesthesiology and Reanimation, Bağcilar Training and Research Hospital, University of Health Sciences, Istanbul.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Karagöz', 'Affiliation': 'Department of Cardiology, Kartal Kosuyolu Research and Training Hospital, University of Health Sciences, İstanbul.'}, {'ForeName': 'İrfan', 'Initials': 'İ', 'LastName': 'Şahin', 'Affiliation': 'Department of Cardiology, Bağcilar Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000575']
2952,34876965,Effectiveness and Prognosis: Drainage Skin-Bridge Sparing Surgery Combined with Fistulotomy versus Fistulotomy Only in the Treatment of Anal Fistula.,"Objective


This study intends to analyze the difference in the efficacy of drainage skin-bridge sparing surgery combined fistulotomy (DSCF) and fistulotomy alone.
Methods


125 patients with anal fistula were enrolled as study subjects and randomly divided into control group (CG) and observation group (OG) by double-blind lottery. The CG received drainage skin-bridge sparing surgery with fistulotomy and the OG received fistulotomy only.
Results


The VAS scores of the trauma in the OG were lower than those in the CG on 1st day of surgery and 7 days after surgery ( P  < 0.05). The length of hospital stay and time to wound healing were shorter in the OG than in the CG ( P  < 0.05). The incidence of postoperative bleeding in the OG was 9.52%, which was lower than 22.58% in the CG ( P  < 0.05). The rectal examination scores were lower in the OG than in the CG at 3 and 5 days postoperatively ( P  < 0.05). The Wexner scores of solid incontinence (0 to 4), liquid incontinence (0 to 4), gas incontinence (0 to 4), pad wearing (0 to 4), and lifestyle alteration (0 to 4) in the OG were lower than those of the CG at 5 days postoperatively ( P  < 0.05). Voiding function scores were lower in the OG than in the CG at 2 and 3 days postoperatively ( P  < 0.05).
Conclusions


The efficacy of drainage skin-bridge sparing surgery combined fistulotomy is better than that of fistulotomy alone, which can accelerate postoperative healing, enhance urinary function, reduce postoperative bleeding, and improve anal function.",2021,"Voiding function scores were lower in the OG than in the CG at 2 and 3 days postoperatively ( P  < 0.05).
",['125 patients with anal fistula'],"['drainage skin-bridge sparing surgery combined fistulotomy', 'Fistulotomy versus Fistulotomy', 'drainage skin-bridge sparing surgery combined fistulotomy (DSCF) and fistulotomy alone', 'control group (CG) and observation group (OG) by double-blind lottery', 'Prognosis: Drainage Skin-Bridge Sparing Surgery']","['VAS scores of the trauma in the OG', 'length of hospital stay and time to wound healing', 'Voiding function scores', 'incidence of postoperative bleeding', 'rectal examination scores', 'Wexner scores of solid incontinence (0 to 4), liquid incontinence (0 to 4), gas incontinence (0 to 4), pad wearing (0 to 4), and lifestyle alteration']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149889', 'cui_str': 'Anorectal fistula'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0744044', 'cui_str': 'Fistulotomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0199900', 'cui_str': 'Rectal examination'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C4087409', 'cui_str': 'Gas incontinence'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]",125.0,0.0449947,"Voiding function scores were lower in the OG than in the CG at 2 and 3 days postoperatively ( P  < 0.05).
","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Anorectal Surgery, The First People's Hospital of Fuyang Hangzhou, Hangzhou, Zhejiang 311400, China.""}, {'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Anorectal Surgery, The First People's Hospital of Fuyang Hangzhou, Hangzhou, Zhejiang 311400, China.""}, {'ForeName': 'Ruihua', 'Initials': 'R', 'LastName': 'Qi', 'Affiliation': ""Department of Anorectal Surgery, The First People's Hospital of Fuyang Hangzhou, Hangzhou, Zhejiang 311400, China.""}]",Journal of healthcare engineering,['10.1155/2021/6940072']
2953,34871427,Bioavailable Lysine Assessed Using the Indicator Amino Acid Oxidation Method in Healthy Young Males is High when Sorghum is Cooked by a Moist Cooking Method.,"BACKGROUND


Sorghum is the fifth most consumed cereal grain but limiting in the indispensable amino acid lysine. Complementing sorghum with lentils can improve the quality of sorghum-based diets. However, knowledge of lysine bioavailability in sorghum is lacking.
OBJECTIVES


The study objectives were to determine the bioavailability of lysine in sorghum and to assess the effect of complementation of sorghum and lentils in a mixed-meal format.
METHODS


We studied 5 healthy young men (≤30 years; BMI <25 kg/m2) in a repeated-measure design using the indicator amino acid oxidation (IAAO) method, with L-[1-13C] phenylalanine as the indicator. Each subject participated in 8 determinations in random order. On the reference diet, subjects received 4 amounts of L-lysine (5, 8, 12, and 15 mg. kg-1 . d-1) from a crystalline amino acid mixture patterned after egg protein. On the test diet, they received 3 levels of lysine (8.2, 12.5, and 15.7 mg. kg-1 . d-1) from sorghum, and on the complementation diet they received 1 level of lysine from a mixed meal of sorghum and lentils. The bioavailability of lysine in sorghum was estimated by comparing the IAAO response to the test diet with the IAAO response to the reference diet using the slope-ratio method. Effectiveness of complementation was assessed by comparing the IAAO response to the mixed meal to the IAAO response to the test protein.
RESULTS


The bioavailability of lysine from sorghum was 94%. Upon complementation with lentils, there was a decline in the oxidation of L-[1-13C] phenylalanine by 19% (P < 0.0495), reflecting an improvement in available lysine in the mixed meal due to increased lysine intake.
CONCLUSIONS


Although the bioavailability of lysine in sorghum is high, its lysine content is limiting. Complementation with lentils in a 1:1 ratio is recommended to achieve the lysine requirement for adult men consuming a sorghum-based diet. This trial was registered at clinicaltrials.gov as NCT03411005.",2022,"Upon complementation with lentils, there was a decline in the oxidation of L-[1-13C] phenylalanine by 19% (P < 0.0495), reflecting an improvement in available lysine in the mixed meal due to increased lysine intake.
","['Healthy Young Males', '5 healthy young men (≤30 years; BMI\xa0<25\xa0kg/m2']","['L-lysine', 'indicator amino acid oxidation (IAAO) method, with L-[1-13C] phenylalanine']","['oxidation of L-[1-13C] phenylalanine', 'IAAO response', 'bioavailability of lysine']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}]","[{'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}]",5.0,0.0502821,"Upon complementation with lentils, there was a decline in the oxidation of L-[1-13C] phenylalanine by 19% (P < 0.0495), reflecting an improvement in available lysine in the mixed meal due to increased lysine intake.
","[{'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Paoletti', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Abrar', 'Initials': 'A', 'LastName': 'Fakiha', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Zujaja', 'Initials': 'Z', 'LastName': 'Tul-Noor', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Pencharz', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Crystal L', 'Initials': 'CL', 'LastName': 'Levesque', 'Affiliation': 'Department of Animal Science, South Dakota State University, Brookings, South Dakota, USA.'}, {'ForeName': 'Ronald O', 'Initials': 'RO', 'LastName': 'Ball', 'Affiliation': 'Department\xa0of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Dehan', 'Initials': 'D', 'LastName': 'Kong', 'Affiliation': 'Department of Statistical Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Rajavel', 'Initials': 'R', 'LastName': 'Elango', 'Affiliation': 'Department of Pediatrics, School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Courtney-Martin', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxab410']
2954,34863239,"Efficacy and safety of treating chronic nonspecific low back pain with radial extracorporeal shock wave therapy (rESWT), rESWT combined with celecoxib and eperisone (C + E) or C + E alone: a prospective, randomized trial.","BACKGROUND


To investigate whether respectively radial extracoporeal shock wave therapy (rESWT) or a combination of rESWT, celecoxib and eperisone (rESWT + C + E) are superior in reducing pain in patients with chronic nonspecific low back pain (cnsLBP) compared to C + E alone (a standard treatment of this condition in China).
METHODS


140 patients with cnsLBP were randomly allocated to rESWT (n = 47), rESWT + C + E (n = 45) or C + E alone (n = 48) for four weeks between November 2017 and March 2019. Outcome was evaluated using the Pain Self-Efficacy Questionnaire (PSEQ), Numerical Rating Scale (NRS), Oswestry Low Back Pain Disability Questionnaire and Patient Health Questionnaire 9, collected at baseline as well as one week (W1), W2, W3, W4 and W12 after baseline.
RESULTS


All scores showed a statistically significant improvement over time. The PSEQ and NRS scores showed a significant Time × Treatment effect. Patients treated with rESWT had significantly lower mean NRS values than patients treated with rESWT + C + E at W1 and W3, as well as than patients treated with C + E alone at W3 and W4. No severe adverse events were observed.
CONCLUSIONS


rESWT may not be inferior to respectively rESWT + C + E or C + E alone in reducing pain in patients with cnsLBP.
LEVEL OF EVIDENCE


Level I, prospective, randomized, active-controlled trial.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier NCT03337607. Registered November 09, 2017, https://www.clinicaltrials.gov/ct2/show/NCT03337607 .
LEVEL OF EVIDENCE


Level I; prospective, randomized, controlled trial.",2021,"Patients treated with rESWT had significantly lower mean NRS values than patients treated with rESWT + C + E at W1 and W3, as well as than patients treated with C + E alone at W3 and W4.","['patients with cnsLBP', '140 patients with cnsLBP', 'patients with chronic nonspecific low back pain (cnsLBP']","['rESWT\u2009+\u2009C\u2009+\u2009E (n\u2009=\u200945) or C\u2009+\u2009E alone', 'radial extracorporeal shock wave therapy (rESWT), rESWT combined with celecoxib and eperisone (C\u2009+\u2009E) or C\u2009+\u2009E alone', 'rESWT', 'rESWT, celecoxib and eperisone (rESWT\u2009+\u2009C\u2009+\u2009E', 'radial extracoporeal shock wave therapy (rESWT']","['pain', 'mean NRS values', 'Pain Self-Efficacy Questionnaire (PSEQ), Numerical Rating Scale (NRS), Oswestry Low Back Pain Disability Questionnaire and Patient Health Questionnaire 9, collected at baseline as well as one week (W1), W2, W3, W4 and W12 after baseline', 'Efficacy and safety', 'PSEQ and NRS scores', 'severe adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0043606', 'cui_str': 'eperisone'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4075347', 'cui_str': 'Pain Self-efficacy Questionnaire'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0078435', 'cui_str': 'W 12'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",140.0,0.0764725,"Patients treated with rESWT had significantly lower mean NRS values than patients treated with rESWT + C + E at W1 and W3, as well as than patients treated with C + E alone at W3 and W4.","[{'ForeName': 'Xuejiao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Pain Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pain Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'Department of Pain Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yunze', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Pain Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Zhiyou', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': 'Department of Pain Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Pain Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yanfeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Pain Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schmitz', 'Affiliation': 'Extracorporeal Shock Wave Research Unit, Chair of Neuroanatomy, Institute of Anatomy, Faculty of Medicine, LMU Munich, Munich, Germany.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': 'Department of Pain Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. fzy1972@zju.edu.cn.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-021-02848-x']
2955,34888667,Validation of MINORMIX Approach for Estimation of Low Birthweight Prevalence Using a Rural Nepal Dataset.,"BACKGROUND


The Global Nutrition Target of reducing low birthweight (LBW) by ≥30% between 2012 and 2025 has led to renewed interest in producing accurate, population-based, national LBW estimates. Low- and middle-income countries rely on household surveys for birthweight data. These data are frequently incomplete and exhibit strong ""heaping."" Standard survey adjustment methods produce estimates with residual bias. The global database used to report against the LBW Global Nutrition Target adjusts survey data using a new MINORMIX (multiple imputation followed by normal mixture) approach: 1) multiple imputation to address missing birthweights, followed by 2) use of a 2-component normal mixture model to account for heaping of birthweights.
OBJECTIVES


To evaluate the performance of the MINORMIX birthweight adjustment approach and alternative methods against gold-standard measured birthweights in rural Nepal.
METHODS


As part of a community-randomized trial in rural Nepal, we measured ""gold-standard"" birthweights at birth and returned 1-24 mo later to collect maternally reported birthweights using standard survey methods. We compared estimates of LBW from maternally reported data derived using: 1) the new MINORMAX approach; 2) the previously used Blanc-Wardlaw adjustment; or 3) no adjustment for missingness or heaping against our gold standard. We also assessed the independent contribution of multiple imputation and curve fitting to LBW adjustment.
RESULTS


Our gold standard found 27.7% of newborns were LBW. The unadjusted LBW estimate based on maternal report with simulated missing birthweights was 14.5% (95% CI: 11.6, 18.0%). Application of the Blanc-Wardlaw adjustment increased the LBW estimate to 20.6%. The MINORMIX approach produced an estimate of 26.4% (95% CI: 23.5, 29.3%) LBW, closest to and with bounds encompassing the measured point estimate.
CONCLUSIONS


In a rural Nepal validation dataset, the MINORMIX method generated a more accurate LBW estimate than the previously applied adjustment method. This supports the use of the MINORMIX method to produce estimates for tracking the LBW Global Nutrition Target.",2022,"In a rural Nepal validation dataset, the MINORMIX method generated a more accurate LBW estimate than the previously applied adjustment method.",[],[],"['LBW estimate', 'unadjusted LBW estimate based on maternal report with simulated missing birthweights']",[],[],"[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]",,0.0386102,"In a rural Nepal validation dataset, the MINORMIX method generated a more accurate LBW estimate than the previously applied adjustment method.","[{'ForeName': 'Karen T', 'Initials': 'KT', 'LastName': 'Chang', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health,, Baltimore, MD, USA.'}, {'ForeName': 'Emily D', 'Initials': 'ED', 'LastName': 'Carter', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health,, Baltimore, MD, USA.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Mullany', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health,, Baltimore, MD, USA.'}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Nepal Nutrition Intervention Project-Sarlahi, Lalitpur, Nepal.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Cousens', 'Affiliation': 'Maternal Adolescent Reproductive & Child Health (MARCH) Centre, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Xiaoyi', 'Initials': 'X', 'LastName': 'An', 'Affiliation': 'Data and Analytics Section, Division of Data, Analytics Planning and Monitoring, UNICEF, New York, NY, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Krasevec', 'Affiliation': 'Data and Analytics Section, Division of Data, Analytics Planning and Monitoring, UNICEF, New York, NY, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'LeClerq', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health,, Baltimore, MD, USA.'}, {'ForeName': 'Melinda K', 'Initials': 'MK', 'LastName': 'Munos', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health,, Baltimore, MD, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health,, Baltimore, MD, USA.'}]",The Journal of nutrition,['10.1093/jn/nxab417']
2956,34880980,Ultrasound Elastography under Deep Learning Algorithm to Analyze the Therapeutic Effect of Clustered Regularly Interspaced Short Palindromic Repeats Short Hairpin Ribonucleic Acid Nanoparticles on Cervical Cancer.,"This study aimed to analyze the effect of the deep learning algorithm on ultrasound elastography on the treatment of cervical cancer with clustered regularly interspaced short palindromic repeats (CRISPR) short hairpin ribonucleic acid (shRNA) nanoparticles, aiming to provide a reference for the clinical application of deep learning to analyze the therapeutic effect of the disease. In this study, CRISPR and shRNA plasmid nanoparticle drugs were used to treat 55 patients with cervical cancer in the experimental group, and normal saline was injected to another 53 patients in the control group, so compare the effect of nanoparticles in the treatment of cervical cancer. Professional doctors and the recurrent neural network (RNN) intelligent algorithm were used to score cervical cancer based on the ultrasound elastograph images by taking blue, green, and red (BGR) as diagnosis criteria. As a result, the experimental group had a total of 217 points before drug administration and a total of 224 points after drug administration. Each patient had an average increase of 0.13 points. The control group had a total of 200 points before drug administration and a total of 223 points after drug administration, and each patient had an average increase of 0.43 points. The experimental group was obviously different from the control group ( P  < 0.05). Each tissue image output by the RNN was clearer than the original image, and the score given by intelligent calculation was faster than that of professional doctors. The monitoring effect of the deep learning RNN intelligent algorithm on the therapeutic effect of nanomedicine was analyzed. It was found that the average accuracy of the experimental group and the control group was 98.95% and 90.34%, respectively; and the experimental group was greatly different from the control group ( P  < 0.05). In short, nano-CRISPR and shRNA drugs had remarkable effects on the treatment of cervical cancer, and the scores given by the deep learning intelligent algorithm were faster and more accurate, which provided theoretical guidance for the clinical application of deep learning algorithms to analyze the treatment effects of diseases.",2021,The experimental group was obviously different from the control group ( P  < 0.05).,"['cervical cancer with clustered regularly interspaced short palindromic repeats (CRISPR) short', '55 patients with cervical cancer']","['hairpin ribonucleic acid (shRNA) nanoparticles', 'deep learning algorithm']",['average accuracy'],"[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0652927,The experimental group was obviously different from the control group ( P  < 0.05).,"[{'ForeName': 'Minghui', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound Diagnosis, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi 830011, Xinjiang, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound Diagnosis, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi 830011, Xinjiang, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Ultrasound Diagnosis, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi 830011, Xinjiang, China.'}]",Journal of healthcare engineering,['10.1155/2021/7538984']
2957,35235371,Regarding the Children's Oncology Group AEWS1031 Trial for Ewing Sarcoma.,,2022,,[],[],[],[],[],[],,0.0823835,,"[{'ForeName': 'Ji-Gan', 'Initials': 'JG', 'LastName': 'Wang', 'Affiliation': 'Ji-Gan Wang, MD, Qiu-Fen Wei, MD, and Qu-Mei Tang, MD, Pediatrics Department, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China; Guangxi Clinical Research Center for Pediatric Diseases, Guangxi, China.'}, {'ForeName': 'Qiu-Fen', 'Initials': 'QF', 'LastName': 'Wei', 'Affiliation': 'Ji-Gan Wang, MD, Qiu-Fen Wei, MD, and Qu-Mei Tang, MD, Pediatrics Department, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China; Guangxi Clinical Research Center for Pediatric Diseases, Guangxi, China.'}, {'ForeName': 'Qu-Mei', 'Initials': 'QM', 'LastName': 'Tang', 'Affiliation': 'Ji-Gan Wang, MD, Qiu-Fen Wei, MD, and Qu-Mei Tang, MD, Pediatrics Department, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China; Guangxi Clinical Research Center for Pediatric Diseases, Guangxi, China.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.02546']
2958,35235659,Dapagliflozin Impairs the Suppression of Endogenous Glucose Production in Type 2 Diabetes Following Oral Glucose.,"OBJECTIVE


To examine the effect of SGLT2 inhibitors (SGLT2i) on endogenous glucose production (EGP) in patients with type 2 diabetes after an oral glucose load.
RESEARCH DESIGN AND METHODS


Forty-eight patients with type 2 diabetes received an 8-h [3-3H]-glucose infusion (protocol I) to assess EGP response to: 1) dapagliflozin (DAPA), 10 mg; 2) exenatide (EXE), 5 μg s.c.; 3) DAPA/EXE; and 4) placebo (PCB). After 2 weeks (protocol II), patients were restudied with a 5-h double-tracer (i.v. [3-3H]-glucose and oral [1-14C]-glucose) oral glucose tolerance test (OGTT) preceded by PCB, DAPA, EXE, or DAPA/EXE.
RESULTS


Protocol I: EGP decreased (P < 0.01) with PCB (2.16 ± 0.15 to 1.57 ± 0.08 mg/kg/min) and EXE (2.13 ± 0.16 to 1.58 ± 0.03) and remained unchanged (P = NS) with DAPA (2.04 ± 0.17 vs. 1.94 ± 0.18) and DAPA/EXE (2.13 ± 0.10 vs. 2.09 ± 0.03). During OGTT, EGP decreased (P < 0.01) with PCB (2.30 ± 0.05 to. 1.45 ± 0.06 mg/kg/min) and EXE (2.53 ± 0.08 to 1.36 ± 0.06); with DAPA (2.20 ± 0.04 vs. 1.71 ± 0.07) and DAPA/EXE (2.48 ± 0.05 vs. 1.64 ± 0.07), the decrease in EGP was attenuated (both P < 0.05). During OGTT, the insulin/glucagon (INS/GCN) ratio increased in PCB (0.26 ± 0.03 vs. 0.71 ± 0.06 μU/mL per pg/mL), whereas in DAPA (0.26 ± 0.02 to 0.50 ± 0.04), the increase was blunted (P < 0.05). In EXE, INS/GCN increased significantly (0.32 ± 0.03 to 1.31 ± 0.08) and was attenuated in DAPA/EXE (0.32 ± 0.03 vs. 0.78 ± 0.08) (P < 0.01).
CONCLUSIONS


These findings provide novel evidence that the increase in EGP induced by SGLT2i is present during an oral glucose load. The fact that stimulation of EGP occurs despite elevated plasma insulin and glucagon suggests that additional factors must be involved.",2022,the decrease in EGP was attenuated (both P < 0.05).,"['patients with type 2 diabetes after an oral glucose load', 'Type 2 Diabetes Following Oral Glucose', 'Forty-eight patients with type 2 diabetes received an']","['8-h [3-3H]-glucose infusion (protocol I) to assess EGP response to: 1) dapagliflozin (DAPA), 10 mg; 2) exenatide (EXE', 'SGLT2 inhibitors (SGLT2i', 'EGP', '3-3H]-glucose and oral [1-14C]-glucose) oral glucose tolerance test (OGTT', 'Dapagliflozin', 'placebo (PCB']","['EGP', 'insulin/glucagon (INS/GCN) ratio', 'endogenous glucose production (EGP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032447', 'cui_str': 'Polychlorinated biphenyl'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",48.0,0.080017,the decrease in EGP was attenuated (both P < 0.05).,"[{'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Alatrach', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Agyin', 'Affiliation': ''}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Solis-Herrera', 'Affiliation': ''}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Lavryneko', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': ''}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': ''}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Triplitt', 'Affiliation': ''}, {'ForeName': 'Ralph A', 'Initials': 'RA', 'LastName': 'DeFronzo', 'Affiliation': ''}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Cersosimo', 'Affiliation': ''}]",Diabetes care,['10.2337/dc21-1798']
2959,35235656,"Efficacy and Safety of Switching to the 2-Drug Regimen Dolutegravir/Lamivudine Versus Continuing a 3- or 4-Drug Regimen for Maintaining Virologic Suppression in Adults Living With HIV-1: Week 48 Results From the Phase 3, Non-inferiority SALSA Randomized Trial.","BACKGROUND


In TANGO, switching to dolutegravir/lamivudine (DTG/3TC) demonstrated long-term non-inferior efficacy vs continuing tenofovir alafenamide-based regimens in treatment-experienced adults with HIV-1. The phase 3 SALSA study evaluated efficacy and safety of switching to DTG/3TC compared with continuing various 3-/4-drug current antiretroviral regimens (CAR).
METHODS


Adults with HIV-1 RNA <50 copies/mL and no previous virologic failure were randomized (1:1, stratified by baseline third agent class) to switch to once-daily fixed-dose combination DTG/3TC or continue CAR (primary endpoint: proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48; Snapshot, intention-to-treat-exposed population, 5% non-inferiority margin).
RESULTS


Overall, 493 adults (39% women; 39% aged ≥50 years; 19% African American/African heritage; 14% Asian) were randomized to switch to DTG/3TC (n=246) or continue CAR (n=247). At Week 48, 1 (0.4%) participant in the DTG/3TC group and 3 (1.2%) in the CAR group had HIV-1 RNA ≥50 copies/mL (Snapshot), demonstrating non-inferiority (adjusted difference, -0.8%; 95% CI, -2.4%, 0.8%). Zero participants met confirmed virologic withdrawal criteria; therefore, no resistance testing was performed. Drug-related adverse events were more frequent with DTG/3TC (20%) than CAR (6%) through Week 48 but comparable post-Week 24 (5% vs 2%, respectively). Proximal tubular renal function and bone turnover biomarkers improved with DTG/3TC. Both groups had generally minimal changes in lipids and inflammatory biomarkers.
CONCLUSIONS


Switching to DTG/3TC was non-inferior to continuing CAR for maintaining virologic suppression at Week 48 with no observed resistance, supporting the efficacy, good safety, and high barrier to resistance of DTG/3TC.",2022,"Drug-related adverse events were more frequent with DTG/3TC (20%) than CAR (6%) through Week 48 but comparable post-Week 24 (5% vs 2%, respectively).","['treatment-experienced adults with HIV-1', '493 adults (39% women; 39% aged ≥50 years; 19% African American/African heritage; 14% Asian', 'Adults with HIV-1 RNA', 'Adults Living With HIV-1']","['DTG/3TC', 'Lamivudine', 'lamivudine (DTG/3TC']","['lipids and inflammatory biomarkers', 'Proximal tubular renal function and bone turnover biomarkers', 'Efficacy and Safety']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",493.0,0.159078,"Drug-related adverse events were more frequent with DTG/3TC (20%) than CAR (6%) through Week 48 but comparable post-Week 24 (5% vs 2%, respectively).","[{'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Llibre', 'Affiliation': 'Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Brites', 'Affiliation': 'Universidade Federal da Bahia, Salvador, Brazil.'}, {'ForeName': 'Chien-Yu', 'Initials': 'CY', 'LastName': 'Cheng', 'Affiliation': 'Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.'}, {'ForeName': 'Olayemi', 'Initials': 'O', 'LastName': 'Osiyemi', 'Affiliation': 'Triple O Research Institute PA, West Palm Beach, FL, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Galera', 'Affiliation': 'Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Hocqueloux', 'Affiliation': ""Centre Hospitalier Régional d'Orléans, Orléans, France.""}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Maggiolo', 'Affiliation': 'ASST Papa Giovanni XXIII, Bergamo, Italy; 9Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Degen', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Birmingham Heartlands Hospital, Birmingham, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Blair', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Choy', 'Initials': 'C', 'LastName': 'Man', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wynne', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Oyee', 'Affiliation': 'GlaxoSmithKline, Brentford, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Curtis', 'Affiliation': 'GlaxoSmithKline, Brentford, UK.'}, {'ForeName': 'Gilda', 'Initials': 'G', 'LastName': 'Bontempo', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'van Wyk', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciac130']
2960,35235636,Two-Year Follow-up Comparison of Three Surgical Techniques for Implant Placement in Posterior Maxilla with Limited Alveolar Bone Height.,"PURPOSE


The aim of this pilot study was to compare three surgical techniques (bicortical fixation, unicortical fixation, and indirect sinus elevation) for implant placement in the posterior maxilla with limited alveolar bone height. This 2-year follow-up assessment on the implants of a previously published prospective clinical trial compared (1) restoration/implant stability among the three surgical groups, (2) intrasinus bone formation between the bicortical fixation and indirect sinus elevation groups, and (3) implant and prosthetic complications reported among the three groups.
MATERIALS AND METHODS


For the original prospective study, 38 patients were recruited, exhibiting 7 to 11 mm of alveolar bone coronal to the sinus floor as confirmed by preoperative CBCT, and 45 implants were placed using three randomly assigned surgical techniques. No patient received more than two implants, which were placed in opposite sides of the maxilla and using different surgical techniques. At the 2-year follow-up assessment, 32 patients with 37 implants were evaluated. The 2-year follow-up restoration/implant stability was measured with the Periotest stability measuring device. Intrasinus bone formation was measured from the 2-year follow-up CBCT in comparison to the preoperative CBCT. Clinical examination was also performed to identify loose implants and/or implant crowns and signs of peri-implantitis. Patients were interviewed regarding complications experienced with the study implants/restorations, and electronic charts were thoroughly reviewed to identify records of complications.
RESULTS


No significant difference in restoration/implant stability (Periotest value [PTV]) was seen between the bicortical fixation, unicortical fixation, and indirect sinus elevation groups (-1.69 [0.80], -1.76 [0.80], -2.22 [0.60], respectively, P = .76) at the 2-year follow-up. The indirect sinus elevation group showed more intrasinus horizontal (1.99 [0.17] vs 1.47 [0.16] mm, P = .03) and vertical (3.15 [0.43] vs 2.35 [0.38] mm, P = .13) bone gain compared with the bicortical fixation group.
CONCLUSION


Within the limitations of this study, placing implants using a bicortical fixation surgical technique in moderately limited alveolar bone height (7 to 11 mm) was not significantly different from the other two techniques and may be a feasible option with limited risks while allowing longer implant placement and negating the need for indirect sinus augmentation, which is accompanied by additional expense and surgical morbidity to the patient.",2022,"No significant difference in restoration/implant stability (Periotest value [PTV]) was seen between the bicortical fixation, unicortical fixation, and indirect sinus elevation groups (-1.69 [0.80], -1.76 [0.80], -2.22 [0.60], respectively, P = .76) at the 2-year follow-up.","['32 patients with 37 implants were evaluated', 'posterior maxilla with limited alveolar bone height', '38 patients were recruited, exhibiting 7 to 11 mm of alveolar bone coronal to the sinus floor as confirmed by preoperative CBCT, and 45 implants', 'Posterior Maxilla with Limited Alveolar Bone Height']","['bicortical fixation surgical technique', 'surgical techniques (bicortical fixation, unicortical fixation, and indirect sinus elevation']","['intrasinus horizontal', '2-year follow-up restoration/implant stability', 'Intrasinus bone formation', 'restoration/implant stability (Periotest value [PTV', 'bone gain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0454199', 'cui_str': 'Planning target volume'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",38.0,0.0176569,"No significant difference in restoration/implant stability (Periotest value [PTV]) was seen between the bicortical fixation, unicortical fixation, and indirect sinus elevation groups (-1.69 [0.80], -1.76 [0.80], -2.22 [0.60], respectively, P = .76) at the 2-year follow-up.","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Wolff', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hsu', 'Affiliation': ''}, {'ForeName': 'YoungCheul', 'Initials': 'Y', 'LastName': 'Heo', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Evans', 'Affiliation': ''}, {'ForeName': 'WookJin', 'Initials': 'W', 'LastName': 'Seong', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.8302']
2961,35235635,"Liquid Platelet-Rich Fibrin Coating Implant Surface to Enhance Osseointegration: A Double-Blinded, Randomized Split-Mouth Trial with 1-Year Follow-up.","PURPOSE


The goal of this study was to assess the effect of a liquid platelet-rich fibrin (PRF)-coated implant surface (double acid-etched) on osseointegration, analyzing the stability and the possibility of shortening the rehabilitation period.
MATERIALS AND METHODS


Initially, the blood was centrifuged to obtain the liquid PRF (2,000 revolutions per minute [rpm], 10 minutes), dividing a sample to be analyzed by Luminex, and another was applied onto the implant surface. Fifteen patients (30 implants) were divided into two groups (control and liquid PRF). Following the recommendation provided by the manufacturer, within a controlled torque at a maximum of 34 N.mm, the implant was placed. All patients had 1 year of follow-up.
RESULTS


Eleven analytes were identified for the sample characterization (IP-10, eotaxin, RANTES, macrophage inflammatory protein 1-beta [MIP-1β], VEGF, PDGF-BB, bFGF, IFN-γ, interleukin [IL]-5, IL-10, and IL-15). Regarding clinical evaluation, for control and liquid PRF groups, respectively, (1) the mean torque for implant placement was 26.67 and 27.27 N.mm; (2) the initial stability (implant stability quotient [ISQ]) was 64.87 (SD ± 6.01) and 67.36 (SD ± 7.21); (3) the final ISQ was 67.67 (SD ± 6.13) and 70.14 (SD ± 6.40); (4) it took an average 73 and 71 days to reestablish the masticatory function; (5) the survival rate was 93.3% and 86.6%; and (6) the marginal bone loss was up to 1.0 mm after 1 year (control)-for two patients, it was between 1.0 and 2.0 mm, and for another two subjects, it was up to 1 mm (liquid PRF). No statistical significance was observed for all parameters analyzed (P > .05).
CONCLUSION


Within the limitations of this study, the results indicated that there was no statistical significance when liquid PRF was applied on the implant surface, for all parameters.",2022,"RESULTS


Eleven analytes were identified for the sample characterization (IP-10, eotaxin, RANTES, macrophage inflammatory protein 1-beta [MIP-1β], VEGF, PDGF-BB, bFGF, IFN-γ, interleukin [IL]-5, IL-10, and IL-15).","['Fifteen patients (30 implants', 'All patients had 1 year of follow-up']","['liquid PRF', 'liquid platelet-rich fibrin (PRF)-coated implant surface (double acid-etched']","['initial stability (implant stability quotient [ISQ', 'mean torque for implant placement', 'survival rate', 'Osseointegration', 'marginal bone loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0079949', 'cui_str': 'Osseointegration'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",11.0,0.116189,"RESULTS


Eleven analytes were identified for the sample characterization (IP-10, eotaxin, RANTES, macrophage inflammatory protein 1-beta [MIP-1β], VEGF, PDGF-BB, bFGF, IFN-γ, interleukin [IL]-5, IL-10, and IL-15).","[{'ForeName': 'Gustavo Vicentis', 'Initials': 'GV', 'LastName': 'de Oliveira Fernandes', 'Affiliation': ''}, {'ForeName': 'Nuno Bernardo', 'Initials': 'NB', 'LastName': 'Malta Santos', 'Affiliation': ''}, {'ForeName': 'Manuel Fernando', 'Initials': 'MF', 'LastName': 'Correia de Sousa', 'Affiliation': ''}, {'ForeName': 'Juliana Campos Hasse', 'Initials': 'JCH', 'LastName': 'Fernandes', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.9107']
2962,35235632,"Are the Insertion Torque Value and Implant Stability Quotient Correlated, and If So, Can Insertion Torque Values Predict Secondary Implant Stability? A Prospective Parallel Cohort Study.","PURPOSE


Primary stability is the most important prognostic index for predicting osseointegration. It is generally thought that to achieve high primary stability, it is necessary to insert an implant with a high insertion torque (IT). To date, it has not yet been determined whether IT and implant stability quotient (ISQ) values are correlated. The primary aim of the study was to determine the correlation between IT and ISQ values at the time of implant insertion (T0); at 2 months, the time of healing (T1); and at 6 (T2) and 12 months (T3) after loading. The secondary aims were to determine the influence of different macroscopic implant designs and of a different insertion arch on this correlation; and to assess whether implants inserted with a high IT, that is, > 50 Ncm, had higher levels of implant stability at 2-, 6-, and 12-month follow-ups.
MATERIALS AND METHODS


STROBE guidelines were followed. Partially or monoedentulous patients were randomly assigned to receive taper thread on straight-body implants with microthreads (group A) or without microthreads (group B). At implant insertion, IT and ISQ values were recorded. At 2-, 6-, and 12-month follow-ups, the ISQ values were recorded. A spring-style torque wrench was used to assess the IT. The Osstell device was used to determine the ISQ values. Descriptive statistics, Pearson correlation, and t test were used. P was set at ≤ .005.
RESULTS


Two hundred fifty subjects were assessed; 142 were included. Two hundred sixty-eight implants were inserted (group A, 137 implants; group B, 131 implants). No subject dropped out, and no implant failed. A statistically significant correlation between ISQ and IT was determined at the time of implant insertion (T0; P = .000). The implant morphology and arch did not influence the correlation. An IT > 50 did not determine a higher secondary stability.
CONCLUSION


There is a strong correlation between IT and primary stability, but IT is not correlated with the secondary stability. A different implant macroscopic design and a different arch of insertion did not influence this correlation. Moreover, implants inserted with IT > 50 Ncm do not result in greater secondary stability.",2022,Partially or monoedentulous patients were randomly assigned to receive taper thread on straight-body implants with microthreads (group A) or without microthreads (group B).,"['Two hundred fifty subjects were assessed; 142 were included', 'Two hundred sixty-eight implants were inserted (group A, 137 implants; group B, 131 implants']",['straight-body implants with microthreads (group A) or without microthreads'],"['IT and ISQ values', 'implant stability quotient (ISQ) values', 'time of healing (T1']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",268.0,0.0283479,Partially or monoedentulous patients were randomly assigned to receive taper thread on straight-body implants with microthreads (group A) or without microthreads (group B).,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cassetta', 'Affiliation': ''}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Brandetti', 'Affiliation': ''}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Altieri', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.9064']
2963,35235629,Evaluation of Bone Density in Sinus Elevation by Using Allograft and Xenograft: A CBCT Study.,"PURPOSE


The stability and density of the grafted bone in the maxillary sinus are essential for dental implant survival. This study aimed to compare bone density following mineralized allogeneic bone and deproteinized bovine bone and evaluate the volumetric changes as the secondary outcome.
MATERIALS AND METHODS


In this prospective cohort study, subjects were randomly allocated into two groups of mineralized bone and deproteinized bone to augment the maxillary sinus. Subjects underwent CBCT immediately after augmentation and 9 months later. The relative bone density was the primary outcome, and the volumetric change after 9 months was the secondary outcome of the study. The authors used an independent t test for assessing the bone density and volumetric change between the two groups.
RESULTS


Fifty patients were studied (n = 25 in each group). At 9 months after sinus elevation, the mean bone density was 237.20 ± 55.72 Hounsfield units (HU) in group 1 (mineralized bone) and 634.8 ± 166.11 HU in group 2 (deproteinized bone). There was a substantial difference statistically for the mean of HU between groups 1 and 2 (P < .001). The mean volume change was 0.25 ± 0.13 cm 3  in group 1 (mineralized bone) and 0.06 ± 0.05 cm 3  in group 2 (deproteinized bone). Assessment of the data showed a substantial difference in the mean volume change at 9 months after sinus elevation between groups 1 and 2 (P < .001).
CONCLUSION


Considering the results of this study, the deproteinized bone was associated with higher relative bone density than the mineralized bone 9 months after sinus elevation. The volume change of the deproteinized bone was less than the mineralized bone in the study time.",2022,There was a substantial difference statistically for the mean of HU between groups 1 and 2 (P < .001).,['Fifty patients were studied (n = 25 in each group'],"['mineralized allogeneic bone and deproteinized bovine bone', 'mineralized bone and deproteinized bone to augment the maxillary sinus', 'Allograft and Xenograft']","['relative bone density', 'volumetric change', 'mean of HU', 'bone density and volumetric change', 'mean bone density', 'mean volume change', 'bone density']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",50.0,0.0155305,There was a substantial difference statistically for the mean of HU between groups 1 and 2 (P < .001).,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Tabrizi', 'Affiliation': ''}, {'ForeName': 'Hassan Mirmohammad', 'Initials': 'HM', 'LastName': 'Sadeghi', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': ''}, {'ForeName': 'Mehrdad Dehghanpour', 'Initials': 'MD', 'LastName': 'Barouj', 'Affiliation': ''}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Kheyrkhahi', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.9116']
2964,35229675,Effects of a cluster-randomized exercise intervention on cardiovascular health in preschoolers.,"Primary health prevention in at-risk children is receiving increased attention while less information is available on cardiovascular profile and response to exercise in healthy children. Our study examined the effects of a gross motor skill-based exercise intervention on micro- and macro-vascular health in preschoolers. This is a sub-study of a five-armed clinical trial with six kindergartens and 68 children. Four kindergartens were assigned to the intervention group (INT) and two to control groups (CON). We performed gross motor skill assessment (TGMD-2), static retinal vessel analysis, and measurements of central hemodynamics before and after the intervention. INT received one weekly exercise session for 25 weeks, while CON received no intervention. We calculated linear regressions correcting for age, sex, BMI-percentile, and baseline. We observed favorable effects in TGMD-2 for INT over CON (Cohen's  d  = 0.52 95% CI [0.15; 0.90]). Trivial between-group differences were observed in retinal vessel diameters (0.08 <  d  ≤ 0.29) and trivial to moderate differences in all other arterial stiffness parameters (-0.55 <  d  ≤ 0.31). Motor-skill based interventions are sensible measures to incorporate physical activity in pre-schools and improve gross motor proficiency at a very young age. The potential of motor skill-based interventions as primordial prevention strategy in healthy preschoolers needs to be further investigated.",2022,We observed favorable effects in TGMD-2 for INT over CON (Cohen's  d  = 0.52 95% CI [0.15; 0.90]).,"['preschoolers', 'healthy children', '68 children', 'healthy preschoolers', 'at-risk children']","['CON received no intervention', 'cluster-randomized exercise intervention', 'gross motor skill-based exercise intervention', 'motor skill-based interventions']","['micro- and macro-vascular health', 'retinal vessel diameters', 'motor skill assessment (TGMD-2), static retinal vessel analysis, and measurements of central hemodynamics', 'cardiovascular health']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035330', 'cui_str': 'Structure of blood vessel of retina'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",4.0,0.019311,We observed favorable effects in TGMD-2 for INT over CON (Cohen's  d  = 0.52 95% CI [0.15; 0.90]).,"[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Minghetti', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Faude', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Switzerland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Donath', 'Affiliation': 'Department of Intervention Research in Exercise Training, 14926German Sport University Cologne, Germany.'}, {'ForeName': 'Henner', 'Initials': 'H', 'LastName': 'Hanssen', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Switzerland.'}]",Journal of child health care : for professionals working with children in the hospital and community,['10.1177/13674935221078368']
2965,35229616,Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation: Per-Protocol Analysis of the GLOBAL LEADERS Trial.,"Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention-to-treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention-to-treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per-protocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time-varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all-cause mortality or nonfatal Q-wave myocardial infarction at 2 years. At 2-year follow-up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per-protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75-1.03;  P =0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79-1.26;  P =0.99). The per-protocol and intention-to-treat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1-year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.",2022,The primary end point was a composite of all-cause mortality or nonfatal Q-wave myocardial infarction at 2 years.,"['patients who complied with the study protocol', 'patients who did not deviate from the study protocol']","['ticagrelor plus aspirin', 'Drug-Eluting Stent Implantation', 'aspirin', 'Ticagrelor Monotherapy or Dual Antiplatelet Therapy', 'ticagrelor monotherapy']","['rate ratio', 'composite of all-cause mortality or nonfatal Q-wave myocardial infarction', 'rate ratio for the key safety end point of major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.394623,The primary end point was a composite of all-cause mortality or nonfatal Q-wave myocardial infarction at 2 years.,"[{'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Gragnano', 'Affiliation': 'Department of Cardiology, Inselspital University of Bern Switzerland.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Zwahlen', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine Hartcentrum Hasselt, Jessa Ziekenhuis Hasselt Belgium.'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'Clinical Trials Unit University of Bern Bern Switzerland.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Schmidlin', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Heart Center Campus Kerckhoff of Justus-Liebig-University Giessen Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de ParisFrench Alliance for Cardiovascular Trials AP-HPHôpital Bichat, Institut National de la Santé et de la Recherche Médicale UMR1148 Paris France.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gargiulo', 'Affiliation': 'Department of Advanced Biomedical Sciences Federico II University of Naples Naples Italy.'}, {'ForeName': 'Eugene P', 'Initials': 'EP', 'LastName': 'McFadden', 'Affiliation': 'Cardialysis Core Laboratories and Clinical Trial Management Rotterdam the Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology National University of Ireland Galway Galway Ireland.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Department of Internal Medicine Faculty of Medicine Cardiology Unit Prince of Songkla University Songkhla Thailand.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Benit', 'Affiliation': 'Department of Cardiology Jessa Hospital Hasselt Belgium.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Möllmann', 'Affiliation': 'Department of Cardiology St. Johannes Hospital Dortmund Germany.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Heart Center Imelda Ziekenhuis Bonheiden Belgium.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leonardi', 'Affiliation': 'University of Pavia and Fondazione IRCCS Policlinico San Matteo Pavia Italy.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Zurakowski', 'Affiliation': 'Andrzej Frycz Modrzewski Krakow University Krakow Poland.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Arrivi', 'Affiliation': 'Department of Cardiology Azienda Ospedaliera S. Maria Terni Italy.'}, {'ForeName': 'Robert Jan', 'Initials': 'RJ', 'LastName': 'Van Geuns', 'Affiliation': 'Department of Cardiology Radboudumc, Nijmegen the Netherlands.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Wilhelminenhospital III Department of Medicine, Cardiology and Intensive Care MedicineVienna Austria.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Slagboom', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Amsterdam the Netherlands.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Calabrò', 'Affiliation': 'Department of Translational Medical Sciences University of Campania ""Luigi Vanvitelli"" Naples Italy.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'National Heart and Lung InstituteImperial College London London United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Department of Medicine Applied Health Research Centre Li Ka Shing Knowledge Institute of St Michael's HospitalUniversity of Toronto Ontario Canada.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Cardiocentro Ticino InstituteEnte Ospedaliero Cantonale Lugano Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital University of Bern Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.121.024291']
2966,35230058,Hyperbaric Oxygen to Assist Adults With Opioid Use Disorder in Reducing Methadone Dose.,"ABSTRACT


Opioid withdrawal symptoms can interfere with substance use disorder treatment goals. This study investigated the acceptability, feasibility, and treatment effects of hyperbaric oxygen therapy (HBOT) as an adjunct to reduce withdrawal symptoms for adults initiating a medically supervised methadone dose reduction. Adults prescribed methadone for opioid use disorder were randomized into either a hyperbaric oxygen group (n = 17) or an attention control group (n = 14). The study site was an outpatient opioid treatment program in the northwestern United States. Participants were asked to attend five consecutive daily 90-minute HBOT sessions offered at 2.0 atmospheres absolute with 100% oxygen in a pressurized chamber. Treatment attendance and reported satisfaction were measures of acceptability and feasibility. Medication doses were tracked posttreatment at 1 week, 1 month, and 3 months. Withdrawal symptoms were assessed at baseline and daily during the 5-day intervention period. After randomization, 13 (76.5%) followed through with medical screening and HBOT sessions, and of those, nine (69.2%) completed all five 90-minute HBOT sessions. At 3 months, the treatment group maintained, on average, a 4.3-mg methadone dose reduction compared with an average reduction of 0.25 mg for control group participants. Opioid withdrawal symptoms were reduced after Day 1 of HBOT by twice as much, on average, compared with the control condition. Satisfaction surveys found participants were generally satisfied with ease and comfort of the treatment. The evidence that HBOT is an acceptable, feasible adjunct warrants future trials to determine more conclusively effects on withdrawal symptoms associated with methadone dose taper.",2022,"Opioid withdrawal symptoms were reduced after Day 1 of HBOT by twice as much, on average, compared with the control condition.","['Adults prescribed methadone for opioid use disorder', 'adults initiating a medically supervised methadone dose reduction']","['attention control group', 'hyperbaric oxygen therapy (HBOT', 'hyperbaric oxygen', 'Hyperbaric Oxygen', 'HBOT']","['acceptability and feasibility', 'Withdrawal symptoms', 'withdrawal symptoms', 'Opioid withdrawal symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0029104', 'cui_str': 'Opioid withdrawal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0285848,"Opioid withdrawal symptoms were reduced after Day 1 of HBOT by twice as much, on average, compared with the control condition.","[{'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Odom-Maryon', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Stanek', 'Affiliation': ''}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Roush', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Muriungi', 'Affiliation': ''}, {'ForeName': 'Alvina', 'Initials': 'A', 'LastName': 'Jesse', 'Affiliation': ''}, {'ForeName': 'Raymond M', 'Initials': 'RM', 'LastName': 'Quock', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Layton', 'Affiliation': ''}]",Journal of addictions nursing,['10.1097/JAN.0000000000000447']
2967,35229960,Impact of delivery rate on the acute response to intravenous nicotine: A human laboratory study with implications for regulatory science.,"Faster delivery rate enhances the abuse potential of drugs of abuse, yet systematic studies on the impact of delivery rate on the acute effects of nicotine in humans are lacking. Using an intravenous (IV) nicotine infusion procedure that allows precise control of rate of delivery, we examined the impact of nicotine delivery rate on the positive subjective drug effects, smoking urges, withdrawal, heart rate, blood pressure and attention function in smokers. Twenty-four male and female (ages 21-35) dependent smokers attended five experimental sessions, following overnight abstinence from smoking. Using a crossover design, participants attended five sessions, where they were assigned to a random sequence of saline infusion or 1 mg nicotine delivered over 1, 2.5, 5 or 10 min at rates of 1, 0.4, 0.2 or 0.1 mg/min, respectively. The positive subjective effects of nicotine were most robust under the two faster delivery rate conditions, 1- and 0.4-mg nicotine/min. In contrast, all nicotine delivery rates were equally more effective than saline in alleviating urges to smoke. Likewise, nicotine-induced heart rate increases did not vary with the rate of nicotine delivery. Lastly, the cognitive enhancing effects of nicotine were observed only under the two slowest delivery rate conditions-0.1- and 0.2-mg nicotine/min. Collectively, these findings support the critical role of delivery rate in optimizing nicotine's abuse potential versus potential therapeutic effects and have timely implications for developing novel therapeutics for nicotine dependence, as well as for tobacco regulatory science.",2022,"The positive subjective effects of nicotine were most robust under the two faster delivery rate conditions,","['Twenty-four male and female (ages 21-35) dependent smokers attended five experimental sessions, following overnight abstinence from smoking', 'smokers']","['nicotine', 'saline infusion or 1\xa0mg nicotine', 'intravenous (IV) nicotine']","['positive subjective drug effects, smoking urges, withdrawal, heart rate, blood pressure and attention function', 'heart rate']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",24.0,0.0576312,"The positive subjective effects of nicotine were most robust under the two faster delivery rate conditions,","[{'ForeName': 'Joao P', 'Initials': 'JP', 'LastName': 'De Aquino', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'R Ross', 'Initials': 'RR', 'LastName': 'MacLean', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Elise E', 'Initials': 'EE', 'LastName': 'DeVito', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Eid', 'Affiliation': 'Department of Laboratory Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sofuoglu', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}]",Addiction biology,['10.1111/adb.13161']
2968,35229945,Post-treatment effects of topiramate on alcohol-related outcomes: A combined analysis of two placebo-controlled trials.,"Topiramate reduces drinking and alcohol-related problems and is increasingly being used to treat alcohol use disorder (AUD). In a randomized controlled trial (RCT) of topiramate, rs2832407, a single nucleotide polymorphism (SNP) in the GRIK1 gene moderated topiramate's effects (Study 1). However, a second RCT (Study 2) did not replicate the SNP's moderating effect during treatment. The current analysis combines data from these two studies to examine topiramate's effects on alcohol-related outcomes and on its pharmacogenetic moderation during a 6-month post-treatment period. This analysis includes 308 individuals with problematic alcohol use (67% male; mean age = 51.1; topiramate: 49%, placebo: 51%). It uses generalized linear mixed models to examine changes in self-reported alcohol consumption and alcohol-related problems and concentrations of the liver enzyme γ-glutamyltransferase. The report combines published 3- and 6-month follow-up data from Study 1 with similar, unpublished data from Study 2. Despite robust effects of topiramate on drinking during treatment, the overall multivariate medication effects on outcomes during 3- and 6-month follow-up were not significant (p = 0.08 and p = 0.26, respectively). The moderating effect of the SNP on primary treatment outcomes was also not significant during either follow-up period (p = 0.13 and p = 0.16, respectively). However, during the 3-month post-treatment period, drinks per day was significantly lower in the topiramate group than the placebo group in the rs2832407*CC-genotype group. The robust effects of topiramate on alcohol-related outcomes during treatment diminish substantially once the medication is discontinued. Research is needed both to determine the optimal treatment duration and to identify clinically useful pharmacogenetic moderators of topiramate for treating AUD.",2022,"The moderating effect of the SNP on primary treatment outcomes was also not significant during either follow-up period (p = 0.13 and p = 0.16, respectively).",['308 individuals with problematic alcohol use (67% male; mean age\u2009=\u200951.1'],"['SNP', 'Topiramate', 'topiramate', 'placebo']",['alcohol-related outcomes'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.058978,"The moderating effect of the SNP on primary treatment outcomes was also not significant during either follow-up period (p = 0.13 and p = 0.16, respectively).","[{'ForeName': 'Henry R', 'Initials': 'HR', 'LastName': 'Kranzler', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Feinn', 'Affiliation': 'Frank Netter School of Medicine, Quinnipiac University, Hamden, Connecticut, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Pond', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hartwell', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Gelernter', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine and VA CT Healthcare Center, West Haven, Connecticut, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Crist', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology (KW), Center on Alcohol, Substance Use, and Addictions, University of New Mexico, Albuquerque, New Mexico, USA.'}]",Addiction biology,['10.1111/adb.13130']
2969,35229868,Commentary on: PAIIN (Precise Analgesic Instructions Improve Narcotic Usage): A Randomized Trial.,,2022,,[],['PAIIN (Precise Analgesic Instructions'],['Improve Narcotic Usage'],[],"[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}]",,0.117037,,"[{'ForeName': 'Maunak V', 'Initials': 'MV', 'LastName': 'Rana', 'Affiliation': 'Department of Anesthesia and Critical Care, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Apfelbaum', 'Affiliation': 'Department of Anesthesia and Critical Care, University of Chicago, Chicago, IL, USA.'}]",Aesthetic surgery journal,['10.1093/asj/sjac003']
2970,35230140,Comparison of Multimodal Cocktail to Ropivacaine Intercostal Nerve Block for Chest Pain After Costal Cartilage Harvest: A Randomized Controlled Trial.,"Objective:  To compare the effectiveness of an intercostal nerve block after costal cartilage harvest when a multimodal cocktail or ropivacaine plus patient-controlled analgesia is used, as measured by visual analog scale (VAS) scores, rescue analgesic consumption, and related complications.  Materials and Methods:  Eligible patients who underwent costal cartilage harvest were equally randomized to receive a multimodal cocktail (multimodal group) or ropivacaine plus patient-controlled analgesia (ropivacaine group).  Results:  Of 112 patients assessed, 12 (10.7%) patients were excluded and 100 (89.3%) patients were enrolled and assigned to multimodal group ( n  = 50) and ropivacaine group ( n  = 50). The VAS scores in the multimodal group were significantly lower than those in the ropivacaine group both at rest (0.924 ± 0.073 vs. 1.920 ± 0.073,  p  < 0.001) and during coughing (2.340 ± 0.083 vs. 3.944 ± 0.083,  p  < 0.001) in mixed-effects model analysis. Rescue analgesic consumption and rate of complications were significantly lower in the multimodal group compared with the ropivacaine group (all  p  < 0.05).  Conclusions:  Multimodal cocktail improved chest pain after costal cartilage harvest with less rescue analgesic consumption and complications compared with ropivacaine plus patient-controlled analgesia.  Clinical Trial Registration:  ChiCTR2100042445.",2022,Rescue analgesic consumption and rate of complications were significantly lower in the multimodal group compared with the ropivacaine group (all  p  < 0.05).  ,"['Eligible patients who underwent costal cartilage harvest', 'Of 112 patients assessed, 12 (10.7%) patients were excluded and 100 (89.3%) patients']","['Multimodal cocktail', 'Multimodal Cocktail to Ropivacaine Intercostal Nerve Block', 'ropivacaine', 'multimodal cocktail (multimodal group) or ropivacaine plus patient-controlled analgesia (ropivacaine group']","['Rescue analgesic consumption and rate of complications', 'chest pain', 'Chest Pain', 'VAS scores', 'visual analog scale (VAS) scores, rescue analgesic consumption, and related complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0222787', 'cui_str': 'Structure of costal cartilage'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",112.0,0.201248,Rescue analgesic consumption and rate of complications were significantly lower in the multimodal group compared with the ropivacaine group (all  p  < 0.05).  ,"[{'ForeName': 'Wenfang', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'The Twelfth Department of Plastic Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shijingshan, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The Twelfth Department of Plastic Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shijingshan, Beijing, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'The Twelfth Department of Plastic Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shijingshan, Beijing, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'You', 'Affiliation': 'The Twelfth Department of Plastic Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shijingshan, Beijing, China.'}, {'ForeName': 'Ruobing', 'Initials': 'R', 'LastName': 'Zheng', 'Affiliation': 'The Twelfth Department of Plastic Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shijingshan, Beijing, China.'}, {'ForeName': 'Yihao', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'The Twelfth Department of Plastic Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shijingshan, Beijing, China.'}, {'ForeName': 'Xulong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The Twelfth Department of Plastic Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shijingshan, Beijing, China.'}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'The Twelfth Department of Plastic Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shijingshan, Beijing, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Ruan', 'Affiliation': 'Department of Ear Reconstruction, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shijingshan, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Fan', 'Affiliation': 'The Twelfth Department of Plastic Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shijingshan, Beijing, China.'}]",Facial plastic surgery & aesthetic medicine,['10.1089/fpsam.2021.0264']
2971,35230138,Feasibility of Closed-Loop Insulin Delivery with a Pregnancy Specific Zone Model Predictive Control Algorithm.,"OBJECTIVE


Evaluating the feasibility of closed-loop insulin delivery with a zone model predictive control (zone-MPC) algorithm designed for pregnancy complicated by type 1 diabetes (T1D).
RESEARCH DESIGN AND METHODS


Pregnant women with T1D from 14-32 weeks gestation already using continuous glucose monitor (CGM) augmented pump therapy were enrolled in a two-day multi-center supervised outpatient study evaluating pregnancy-specific zone-MPC based closed-loop control (CLC) with the interoperable artificial pancreas system (iAPS) running on an unlocked smartphone. Meals and activities were unrestricted. The primary outcome was the CGM percentage of time between 63-140 mg/dL compared to participants' one-week run-in period. Early (2-hour) postprandial glucose control was also evaluated.
RESULTS


Eleven participants completed the study (age:30.6±4.1 years, gestational age:20.7±3.5 weeks, weight:76.5±15.3 kg, HbA1c:5.6±0.5%, at enrollment). No serious adverse events occurred. Compared to the one-week run-in, there was an increased percentage of time in 63-140 mg/dL during supervised CLC (CLC:81.5%, run-in:64%, p=0.007) with less time above 140 mg/dL (CLC:16.5%, run-in:30.8%, p=0.029) and time below 63 mg/dL (CLC:2.0%, run-in:5.2%, p=0.039). There was also less time below 54 mg/dL (CLC:0.7%, run-in:1.6%, p=0.030) and above 180 mg/dL (CLC:4.9%, run-in:13.1%, p=0.032). Overnight glucose control was comparable, except for less time above 250 mg/dL (CLC:0%, run-in:3.9%, p=0.030) and lower glucose standard deviation (CLC:23.8 mg/dL, run-in:42.8 mg/dL, p=0.007) during CLC.
CONCLUSION


In this pilot study, use of the pregnancy-specific zone-MPC was feasible in pregnant women with T1D. Although the duration of our study was short and the number of participants was small, our findings add to the limited data available on the use of CLC systems during pregnancy.",2022,"(CLC:16.5%, run-in:30.8%, p=0.029) and time below 63 mg/dL","['pregnant women with T1D', 'Pregnant women with T1D from 14-32 weeks gestation already using continuous glucose monitor (CGM) augmented pump therapy were enrolled in a two-day multi-center supervised outpatient study evaluating', 'pregnancy complicated by type 1 diabetes (T1D']","['Closed-Loop Insulin Delivery', 'pregnancy-specific zone-MPC based closed-loop control (CLC) with the interoperable artificial pancreas system (iAPS) running on an unlocked smartphone', 'closed-loop insulin delivery with a zone model predictive control (zone-MPC) algorithm']","['Early (2-hour) postprandial glucose control', 'Overnight glucose control', 'percentage of time', 'CGM percentage of time']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0336563', 'cui_str': 'Artificial pancreas'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]",11.0,0.0582624,"(CLC:16.5%, run-in:30.8%, p=0.029) and time below 63 mg/dL","[{'ForeName': 'Basak', 'Initials': 'B', 'LastName': 'Ozaslan', 'Affiliation': 'Harvard University, 1812, 29 Oxford Street, Maxwell-Dworkin 338, Cambridge, Massachusetts, United States, 02138; bozaslan@seas.harvard.edu.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Mt Sinai, Endocrinology, 1 Gustave L Levy Place, Box 1055, NY, New York, United States, 10029; carol.levy@mssm.edu.'}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': 'Mayo Clinic , Endocrinology, W 18 A Mayo Building, Rochester, United States, 55905.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': 'Sansum Diabetes Research Institute, 2219 Bath St., Santa Barbara, California, United States, 93111; pinskerj@yahoo.com.'}, {'ForeName': 'Grenye', 'Initials': 'G', 'LastName': ""O'Malley"", 'Affiliation': 'Mount Sinai School of Medicine, 5925, New York, New York, United States; omallg01@mssm.edu.'}, {'ForeName': 'Ravinder Jeet', 'Initials': 'RJ', 'LastName': 'Kaur', 'Affiliation': 'Mayo Clinic, Endocrinology, Rochester, Minnesota, United States; Kaur.Ravinder@mayo.edu.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Castorino', 'Affiliation': 'Sansum Diabetes Research Institute, Clinical Research, 2219 Bath Street, Santa Barbara, California, United States, 93105; Kcastorino@sansum.org.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Levister', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 5925, Medicine, Endocrinology, Diabetes and Bone Disease, New York, New York, United States; camilla.levister@mssm.edu.'}, {'ForeName': 'Mari Charisse', 'Initials': 'MC', 'LastName': 'Trinidad', 'Affiliation': 'Mayo Clinic, 6915, Rochester, Minnesota, United States; Trinidad.MariCharisse@mayo.edu.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Desjardins', 'Affiliation': 'Mayo Clinic, Endocrinology, Rochester, Minnesota, United States; Desjardins.Donna@mayo.edu.'}, {'ForeName': 'Mei Mei', 'Initials': 'MM', 'LastName': 'Church', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, California, United States; mchurch@sansum.org.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Plesser', 'Affiliation': 'Mount Sinai School of Medicine, 5925, New York, New York, United States; mdp75@cornell.edu.'}, {'ForeName': 'Shelly K', 'Initials': 'SK', 'LastName': 'McCrady-Spitzer', 'Affiliation': 'Mayo Clinic, Endocrinology, Rochester, Minnesota, United States; mccradyspitzer.shelly@mayo.edu.'}, {'ForeName': 'Selassie J', 'Initials': 'SJ', 'LastName': 'Ogyaadu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 5925, Division of Endocrinology, 1Gustave L. Levy Place, P.O Box 1055, New York, New York, United States, 10029; selassie.ogyaadu@mssm.edu.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Nelson', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, California, United States; knelson@sansum.org.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Reid', 'Affiliation': 'Mayo Clinic, Endocrinology, Rochester, Minnesota, United States; Reid.Corey@mayo.edu.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Deshpande', 'Affiliation': 'Harvard University, Harvard John A Paulson School of Engineering and Applied Sciences, Cambridge, Massachusetts, United States; sdeshpande@seas.harvard.edu.'}, {'ForeName': 'Walter K', 'Initials': 'WK', 'LastName': 'Kremers', 'Affiliation': 'Mayo Clinic, 6915, Rochester, Minnesota, United States; Kremers.Walter@mayo.edu.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Doyle Iii', 'Affiliation': 'Harvard University, SEAS, 29 Oxford St, Harvard University, Cambridge, Massachusetts, United States, 02138.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Rosenn', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 5925, New York, New York, United States; barak.rosenn@gmail.com.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Dassau', 'Affiliation': 'Harvard University, 29 Oxford St., Cambridge, Massachusetts, United States, 02138.'}]",Diabetes technology & therapeutics,['10.1089/dia.2021.0521']
2972,35230615,Testing the Impact of the Whole-Day Good Behavior Game on Aggressive Behavior: Results of a Classroom-Based Randomized Effectiveness Trial.,"Three generations of developmental epidemiologically based randomized field trials of the Good Behavior Game (GBG) have been delivered to Baltimore elementary schools. With the collaboration of family and community partners, all three trials were directed at decreasing proximal targets of aggressive behavior and improving learning in first-grade classrooms with distal mental health and substance abuse outcomes. GBG is a group-contingent classroom behavior management strategy that promotes classmate/peer concern for each child's positive behavior by rewarding teams with below-criterion levels of aggressive, disruptive behavior. GBG targets early risk factors for the above distal outcomes: aggressive, disruptive behavior, family/school relationships, and school failure. Here, we report on the third-generation randomized prevention trial of the GBG (whole-day first grade program (WD)), including 12 elementary schools. WD enhanced the standard curriculum in the areas of classroom behavior management; academic instruction, particularly reading; and family-classroom partnerships. Using a within-school classroom randomized trial design, we: 1) evaluate the effectiveness of the WD program by sex and cohort and 2) measure variation in WD impact by the quality of teachers' behavior management practices. Data from 961 first graders were used in general growth mixture modeling that accounts for classroom randomization to identify distinct developmental trajectories of aggressive, disruptive behavior and GBG impact on these trajectories. In the chronic high aggression trajectory of males, ratings of aggression after WD implementation and to the end of third grade were significantly lower in the WD condition than in controls in classrooms with a higher WD dosage (Cohort 2) and especially in classrooms with higher quality of WD implementation. For females, we found a modest but significant benefit of GBG in the low trajectory class when cohorts were combined. Regarding policy implications, embedding GBG into the curricula in teacher's colleges could better support student learning and behavior. Clinical Trials Registration number: NCT00257088.",2022,"WD enhanced the standard curriculum in the areas of classroom behavior management; academic instruction, particularly reading; and family-classroom partnerships.",['12 elementary schools'],"['GBG', 'Good Behavior Game (GBG', 'Whole-Day Good Behavior Game']",['Aggressive Behavior'],"[{'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]",,0.0125818,"WD enhanced the standard curriculum in the areas of classroom behavior management; academic instruction, particularly reading; and family-classroom partnerships.","[{'ForeName': 'Holly C', 'Initials': 'HC', 'LastName': 'Wilcox', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 N. Broadway, MD, 21205, Baltimore, USA. hwilcox1@jhmi.edu.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Petras', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 N. Broadway, MD, 21205, Baltimore, USA.'}, {'ForeName': 'Hendricks C', 'Initials': 'HC', 'LastName': 'Brown', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 N. Broadway, MD, 21205, Baltimore, USA.'}, {'ForeName': 'Sheppard G', 'Initials': 'SG', 'LastName': 'Kellam', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 N. Broadway, MD, 21205, Baltimore, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-022-01334-y']
2973,35230600,Performance of a Supervisor Observational Coding System and an Audit and Feedback Intervention.,"Workplace-based clinical supervision is common in community based mental health care for youth and families and could be a leveraged to scale and improve the implementation of evidence-based treatment (EBTs). Accurate methods are needed to measure, monitor, and support supervisor performance with limited disruption to workflow. Audit and Feedback (A&F) interventions may offer some promise in this regard. The study-a randomized controlled trial with 60 clinical supervisors measured longitudinally for 7 months-had two parts: (1) psychometric evaluation of an observational coding system for measuring adherence and competence of EBT supervision and (2) evaluation of an experimental Supervisor Audit and Feedback (SAF) intervention on outcomes of supervisor adherence and competence. All supervisors recorded and uploaded weekly supervision sessions for 7 months, and those in the experimental condition were provided a single, monthly web-based feedback report. Psychometric performance was evaluated using measurement models based in Item Response Theory, and the effect of the SAF intervention was evaluated using mixed-effects regression models. The observational instrument performed well across psychometric indicators of dimensionality, rating scale functionality, and item fit; however, coder reliability was lower for competence than for adherence. Statistically significant A&F effects were largely in the expected directions and consistent with hypotheses. The observational coding system performed well, and a monthly electronic feedback report showed promise in maintaining or improving community-based clinical supervisors' adherence and, to a lesser extent, competence. Limitations discussed include unknown generalizability to the supervision of other EBTs.",2022,"The observational coding system performed well, and a monthly electronic feedback report showed promise in maintaining or improving community-based clinical supervisors' adherence and, to a lesser extent, competence.",['60 clinical supervisors measured longitudinally for 7 months-had two parts: (1) psychometric evaluation of an observational coding system for measuring adherence and competence of EBT supervision and (2) evaluation of an'],"['experimental Supervisor Audit and Feedback (SAF) intervention', 'Audit and Feedback (A&F) interventions', 'Workplace-based clinical supervision']",['Psychometric performance'],"[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C0033920', 'cui_str': 'Psychometric testing'}]",,0.0223149,"The observational coding system performed well, and a monthly electronic feedback report showed promise in maintaining or improving community-based clinical supervisors' adherence and, to a lesser extent, competence.","[{'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Chapman', 'Affiliation': 'Oregon Social Learning Center, Eugene, USA.'}, {'ForeName': 'Sonja K', 'Initials': 'SK', 'LastName': 'Schoenwald', 'Affiliation': 'Oregon Social Learning Center, Eugene, USA. sonja.schoenwald@oslc.org.'}, {'ForeName': 'Ashli J', 'Initials': 'AJ', 'LastName': 'Sheidow', 'Affiliation': 'Oregon Social Learning Center, Eugene, USA.'}, {'ForeName': 'Phillippe B', 'Initials': 'PB', 'LastName': 'Cunningham', 'Affiliation': 'Medical University of South Carolina, Charleston, USA.'}]",Administration and policy in mental health,['10.1007/s10488-022-01191-5']
2974,35230477,Validity of food additive maltodextrin as placebo and effects on human gut physiology: systematic review of placebo-controlled clinical trials.,"PURPOSE


Maltodextrin (MDX) is a polysaccharide food additive commonly used as oral placebo/control to investigate treatments/interventions in humans. The aims of this study were to appraise the MDX effects on human physiology/gut microbiota, and to assess the validity of MDX as a placebo-control.
METHODS


We performed a systematic review of randomized-placebo-controlled clinical trials (RCTs) where MDX was used as an orally consumed placebo. Data were extracted from study results where effects (physiological/microbial) were attributed (or not) to MDX, and from study participant outcomes data, before-and-after MDX consumption, for post-publication 're-analysis' using paired-data statistics.
RESULTS


Of two hundred-sixteen studies on 'MDX/microbiome', seventy RCTs (n = 70) were selected for analysis. Supporting concerns regarding the validity of MDX as a placebo, the majority of RCTs (60%, CI 95% = 0.48-0.76; n = 42/70; Fisher-exact p = 0.001, expected < 5/70) reported MDX-induced physiological (38.1%, n = 16/42; p = 0.005), microbial metabolite (19%, n = 8/42; p = 0.013), or microbiome (50%, n = 21/42; p = 0.0001) effects. MDX-induced alterations on gut microbiome included changes in the Firmicutes and/or Bacteroidetes phyla, and Lactobacillus and/or Bifidobacterium species. Effects on various immunological, inflammatory markers, and gut function/permeability were also documented in 25.6% of the studies (n = 10/42). Notably, there was considerable variability in the direction of effects (decrease/increase), MDX dose, form (powder/pill), duration, and disease/populations studied. Overall, only 20% (n = 14/70; p = 0.026) of studies cross-referenced MDX as a justifiable/innocuous placebo, while 2.9% of studies (n = 2/70) acknowledged their data the opposite.
CONCLUSION


Orally-consumed MDX often (63.9% of RCTs) induces effects on human physiology/gut microbiota. Such effects question the validity of MDX as a placebo-control in human clinical trials.",2022,"MDX-induced alterations on gut microbiome included changes in the Firmicutes and/or Bacteroidetes phyla, and Lactobacillus and/or Bifidobacterium species.","[""Of two hundred-sixteen studies on 'MDX/microbiome', seventy RCTs (n\u2009=\u200970"", 'humans', 'human gut physiology']","['MDX', 'Maltodextrin (MDX', 'placebo', 'food additive maltodextrin']","['microbial metabolite', 'human physiology/gut microbiota', 'various immunological, inflammatory markers, and gut function/permeability']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}]","[{'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016453', 'cui_str': 'Food additive'}]","[{'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]",,0.214645,"MDX-induced alterations on gut microbiome included changes in the Firmicutes and/or Bacteroidetes phyla, and Lactobacillus and/or Bifidobacterium species.","[{'ForeName': 'Rawan', 'Initials': 'R', 'LastName': 'Almutairi', 'Affiliation': 'Department of Pathology, Case Western Reserve University, 2109 Adelbert Road, Cleveland, OH, 44106, USA.'}, {'ForeName': 'Abigail Raffner', 'Initials': 'AR', 'LastName': 'Basson', 'Affiliation': 'Department of Medicine and Division of Gastroenterology & Liver Diseases, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Wearsh', 'Affiliation': 'Department of Pathology, Case Western Reserve University, 2109 Adelbert Road, Cleveland, OH, 44106, USA.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Cominelli', 'Affiliation': 'Department of Medicine and Division of Gastroenterology & Liver Diseases, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rodriguez-Palacios', 'Affiliation': 'Department of Medicine and Division of Gastroenterology & Liver Diseases, Case Western Reserve University School of Medicine, Cleveland, OH, USA. axr503@case.edu.'}]",European journal of nutrition,['10.1007/s00394-022-02802-5']
2975,35230463,Another trial for the TARGET trial.,,2022,,[],[],[],[],[],[],,0.303284,,"[{'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Alshaer', 'Affiliation': 'Infectious Disease Pharmacokinetics Laboratory, College of Pharmacy and Emerging Pathogens Institute, University of Florida, 1600 SW Archer Rd, Medical Science Building, PO Box 100486, Gainesville, FL, 32610, USA. mshaer@ufl.edu.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Peloquin', 'Affiliation': 'Infectious Disease Pharmacokinetics Laboratory, College of Pharmacy and Emerging Pathogens Institute, University of Florida, 1600 SW Archer Rd, Medical Science Building, PO Box 100486, Gainesville, FL, 32610, USA.'}]",Intensive care medicine,['10.1007/s00134-022-06654-9']
2976,35230440,Use of Intravesical Chemotherapy in the US Following Publication of a Randomized Clinical Trial.,,2022,,[],['Intravesical Chemotherapy'],[],[],"[{'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.271354,,"[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lewicki', 'Affiliation': 'Department of Urology, NewYork-Presbyterian Hospital, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Spyridon P', 'Initials': 'SP', 'LastName': 'Basourakos', 'Affiliation': 'Department of Urology, NewYork-Presbyterian Hospital, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Arenas-Gallo', 'Affiliation': 'Department of Urology, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'Department of Healthcare Policy and Research, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Prunty', 'Affiliation': 'Department of Urology, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Scherr', 'Affiliation': 'Department of Urology, NewYork-Presbyterian Hospital, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shoag', 'Affiliation': 'Department of Urology, NewYork-Presbyterian Hospital, Weill Cornell Medicine, New York, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.0602']
2977,35230749,Clinical Pharmacology of Insulin Aspart Biosimilar GP40071: Pharmacokinetic/Pharmacodynamic Comparability in Hyperinsulinemic Euglycemic Clamp Procedure.,"Insulin aspart is a short-acting insulin analogue that is used to control postprandial glycemia levels in diabetic patients. The aim of this clinical trial was to compare the pharmacokinetics and pharmacodynamics of GP40071 (GP-Asp) and NovoRapid Penfill (Novo-Asp) in a hyperinsulinemic euglycemic clamp (HEC). This trial was conducted as a part of a GP40071 biosimilar clinical development program. This was a phase I randomized, double-blind, two-period crossover study. Twenty-six healthy male volunteers aged 18 to 45 years who met the inclusion criteria underwent the procedure of an HEC following a single subcutaneous injection of 0.3 IU/kg of either GP-Asp or Novo-Asp into the abdomen. After doses, plasma glucose levels were monitored every 5 minutes for 8 hours. The adjustment of the glucose infusion rate (GIR) was based on the blood glucose measurements. The GIR values were used to evaluate the PD profiles of the studied drugs. Regular blood sampling was performed during the study to obtain sufficient pharmacokinetic data. The 90% confidence intervals for the geometric mean ratios of the pharmacokinetic (AUC ins.0-t  , C ins.max  ) and pharmacodynamic (GIR max  , AUC GIR0-t  ) parameters of GP-Asp were within the 80%-125% comparability limits. The safety profiles of the drugs were also comparable. Bioequivalence, similar PD, and safety of GP-Asp and Novo-Asp were demonstrated.",2022,The safety profiles of the drugs were also comparable.,"['diabetic patients', 'Twenty-six healthy male volunteers aged 18 to 45\xa0years who met the inclusion criteria underwent the procedure of an HEC following a single subcutaneous injection of 0.3\xa0IU/kg of either GP-Asp or Novo-Asp into the abdomen']","['GP40071 (GP-Asp) and NovoRapid Penfill (Novo-Asp', 'Insulin aspart']","['blood glucose measurements', 'glucose infusion rate (GIR', 'geometric mean ratios of the pharmacokinetic (AUC ins.0-t  , C ins.max  ) and pharmacodynamic (GIR max  , AUC GIR0-t  ) parameters of GP-Asp', 'Bioequivalence, similar PD, and safety of GP-Asp and Novo-Asp', 'plasma glucose levels']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439463', 'cui_str': 'IU/kg'}, {'cui': 'C0004015', 'cui_str': 'Aspartic Acid'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]","[{'cui': 'C0004015', 'cui_str': 'Aspartic Acid'}, {'cui': 'C0939412', 'cui_str': 'NovoRapid'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0004015', 'cui_str': 'Aspartic Acid'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",26.0,0.115035,The safety profiles of the drugs were also comparable.,"[{'ForeName': 'Roman V', 'Initials': 'RV', 'LastName': 'Drai', 'Affiliation': 'R&D center, GEROPHARM, Saint-Petersburg, Russia.'}, {'ForeName': 'Tatiana L', 'Initials': 'TL', 'LastName': 'Karonova', 'Affiliation': 'Institute of Endocrinology, Almazov National Medical Research Center, Saint Petersburg, Russia.'}, {'ForeName': 'Alexander Y', 'Initials': 'AY', 'LastName': 'Mayorov', 'Affiliation': 'Endocrinology Research Centre, Moscow, Russia.'}, {'ForeName': 'Igor E', 'Initials': 'IE', 'LastName': 'Makarenko', 'Affiliation': 'R&D center, GEROPHARM, Saint-Petersburg, Russia.'}, {'ForeName': 'Artem R', 'Initials': 'AR', 'LastName': 'Dorotenko', 'Affiliation': 'R&D center, GEROPHARM, Saint-Petersburg, Russia.'}, {'ForeName': 'Viktoria S', 'Initials': 'VS', 'LastName': 'Kulesh', 'Affiliation': 'R&D center, GEROPHARM, Saint-Petersburg, Russia.'}, {'ForeName': 'Vladislav V', 'Initials': 'VV', 'LastName': 'Kovalik', 'Affiliation': 'R&D center, GEROPHARM, Saint-Petersburg, Russia.'}, {'ForeName': 'Alena T', 'Initials': 'AT', 'LastName': 'Andreeva', 'Affiliation': 'Endocrinology Research Centre, Moscow, Russia.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.1084']
2978,35230677,Low body temperature and mortality in older patients with frailty in the emergency department.,"PURPOSE


The aim of this study was to assess the association between low body temperature and mortality in frail older adults in the emergency department (ED).
METHODS


Inclusion criteria were: ≥ 75 years of age, Clinical Frailty Scale (CFS) score of 4-8, and temperature documented at ED admission. Patients were allocated to three groups by body temperature: low ≤ 36.0 °C, normal 36.1-38.0 and high ≥ 38.1. Odds ratios (OR) for 30-day and 90-day mortality were analysed.
RESULTS


1577 patients, 61.2% female, were included. Overall mortalities were 85/1577 (5.4%) and 144/1557 (9.2%) in the 30-day and 90-day follow-ups, respectively. The ORs for low body temperature were 3.03 (1.72-5.35; P < 0.001) and 2.71 (1.68-4.38; P < 0.001) for 30-day and 90-day mortality, respectively. This association remained when adjusted for age, CFS score and gender. Mortality of the high-temperature group did not differ significantly when compared to the normal-temperature group.
CONCLUSIONS


Low body temperature in frail older ED patients was associated with significantly higher 30- and 90-day mortality.",2022,"The ORs for low body temperature were 3.03 (1.72-5.35; P < 0.001) and 2.71 (1.68-4.38; P < 0.001) for 30-day and 90-day mortality, respectively.","['1577 patients, 61.2% female, were included', 'frail older adults in the emergency department (ED', 'frail older ED patients', 'older patients with frailty in the emergency department', 'Inclusion criteria were:\u2009≥\u200975\xa0years of age, Clinical Frailty Scale (CFS) score of 4-8, and temperature documented at ED admission']",[],"['Mortality', 'Odds ratios (OR) for 30-day and 90-day mortality', '90-day mortality', '30-day and 90-day mortality', 'Overall mortalities', 'Low body temperature and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517833', 'cui_str': '61.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}]",1577.0,0.0329472,"The ORs for low body temperature were 3.03 (1.72-5.35; P < 0.001) and 2.71 (1.68-4.38; P < 0.001) for 30-day and 90-day mortality, respectively.","[{'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Alakare', 'Affiliation': 'Department of Emergency Medicine and Services, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. janne.alakare@espoo.fi.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Kemp', 'Affiliation': 'Department of Emergency Medicine and Services, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Strandberg', 'Affiliation': 'Clinicum, and Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Maaret', 'Initials': 'M', 'LastName': 'Castrén', 'Affiliation': 'Department of Emergency Medicine and Services, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Tolonen', 'Affiliation': 'Department of Internal Medicine, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Veli-Pekka', 'Initials': 'VP', 'LastName': 'Harjola', 'Affiliation': 'Department of Emergency Medicine and Services, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}]",Aging clinical and experimental research,['10.1007/s40520-022-02098-9']
2979,34894028,Is psychosocial rehabilitation useful in older people living in nursing homes? A pilot study on long-term cognitive and behavioural outcomes.,"BACKGROUND


Age-related changes in cognitive and behavioural functions, although common, may vary considerably across individuals and cognitive domains. There is limited evidence focusing on the benefits of training based on cognitive/social learning principles in the elderly. The aim of this study is to investigate the effects of Assertive Social Skill Training (ASST) in improving cognitive and mood outcomes in a sample of older patients living in a Sicilian nursing home.
METHODS


Forty-seven older subjects were enrolled in this case-control study. Each participant was evaluated by a neuropsychologist, through the administration of a short psychometric battery using the Mini-Mental State Examination (MMSE), Frontal Assessment Battery (FAB), and Geriatric Depression Scale (GDS), at three time points: before (T0), immediately following (T1), and 6 months after the end of the training (T2). Both groups received cognitive behavioural therapy and psychological support, but the experimental group received the ASST protocol (60 sessions, five times a week, for 12 weeks, each session lasting about 60 min), whilst the control group participated in group meetings with recreational activities.
RESULTS


Post-hoc analysis showed that only patients receiving ASST presented a statistically significant improvement in global cognitive functions (MMSE: P < 0.001), frontal abilities (FAB: P < 0.001), and mood (GDS: P < 0.001); these positive outcomes were maintained at T2.
CONCLUSIONS


Promising treatments, like the ASST, aimed at potentiating cognitive, behavioural, and social skills, are needed to improve older people's quality of life, especially when they live in nursing homes.",2022,"RESULTS


Post-hoc analysis showed that only patients receiving ASST presented a statistically significant improvement in global cognitive functions (MMSE: P < 0.001), frontal abilities (FAB: P < 0.001), and mood (GDS: P < 0.001); these positive outcomes were maintained at T2.
","['older people living in nursing homes', 'Forty-seven older subjects', 'older patients living in a Sicilian nursing home']","['control group participated in group meetings with recreational activities', 'ASST protocol', 'Assertive Social Skill Training (ASST', 'ASST', 'cognitive behavioural therapy and psychological support']","['cognitive and mood outcomes', 'frontal abilities', 'global cognitive functions', 'Mini-Mental State Examination (MMSE), Frontal Assessment Battery (FAB), and Geriatric Depression Scale (GDS']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0150777', 'cui_str': 'Social skills training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C2732353', 'cui_str': 'Frontal assessment battery'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}]",47.0,0.0240988,"RESULTS


Post-hoc analysis showed that only patients receiving ASST presented a statistically significant improvement in global cognitive functions (MMSE: P < 0.001), frontal abilities (FAB: P < 0.001), and mood (GDS: P < 0.001); these positive outcomes were maintained at T2.
","[{'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'De Luca', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Maggio', 'Affiliation': 'University of Catania, Catania, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Leonardi', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Marra', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Casella', 'Affiliation': 'Department of Neuroscience, AOU Policlinico G. Martino, Messina, Italy.'}, {'ForeName': 'Rocco Salvatore', 'Initials': 'RS', 'LastName': 'Calabrò', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy.'}]",Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society,['10.1111/psyg.12795']
2980,34936382,Alterations of human skin microbiome and expansion of antimicrobial resistance after systemic antibiotics.,"Although systemic antibiotics are critical in controlling infections and reducing morbidity and mortality, overuse of antibiotics is presumed to contribute to negative repercussions such as selection of antimicrobial-resistant organisms and collateral damage to commensal microbes. In a prospective, randomized study of four clinically relevant antibiotic regimens [doxycycline (20 mg or 100 mg), cephalexin, or trimethoprim/sulfamethoxazole], we investigated microbial alterations on skin after administration of systemic antibiotics to healthy human volunteers. Samples from different skin and oral sites, as well as stool, were collected before, during, and up to 1 year after antibiotic use, and shotgun metagenomic sequencing was performed. Taxonomic analysis showed that subjects receiving doxycycline 100 mg and trimethoprim/sulfamethoxazole (TMP/SMX) exhibited greater changes to their skin microbial communities, as compared to those receiving other regimens or untreated controls. Oral and stool microbiota also demonstrated fluctuations after antibiotics. Bacterial culturing in combination with whole-genome sequencing revealed specific emergence, expansion, and persistence of antibiotic-resistant staphylococci harboring  tetK  or  tetL  and  dfrC  or  dfrG  genes in all subjects who received doxycycline 100 mg or TMP/SMX, respectively. Last, analysis of metagenomic data revealed an increase of genes involved in gene mobilization, indicating stress responses of microbes to antibiotics. Collectively, these findings demonstrate direct, long-lasting effects of antibiotics on skin microbial communities, highlighting the skin microbiome as a site for the development and persistence of antibiotic resistance and the risks of overprescribing.",2021,"Bacterial culturing in combination with whole-genome sequencing revealed specific emergence, expansion, and persistence of antibiotic-resistant staphylococci harboring  tetK  or  tetL  and  dfrC  or  dfrG  genes in all subjects who received doxycycline 100 mg or TMP/SMX, respectively.",['healthy human volunteers'],"['trimethoprim/sulfamethoxazole (TMP/SMX', 'doxycycline', 'cephalexin, or trimethoprim/sulfamethoxazole', 'doxycycline 100 mg or TMP/SMX']",['skin microbial communities'],"[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0007716', 'cui_str': 'Cephalexin'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",4.0,0.0190664,"Bacterial culturing in combination with whole-genome sequencing revealed specific emergence, expansion, and persistence of antibiotic-resistant staphylococci harboring  tetK  or  tetL  and  dfrC  or  dfrG  genes in all subjects who received doxycycline 100 mg or TMP/SMX, respectively.","[{'ForeName': 'Jay-Hyun', 'Initials': 'JH', 'LastName': 'Jo', 'Affiliation': 'Dermatology Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD 20892, USA.'}, {'ForeName': 'Catriona P', 'Initials': 'CP', 'LastName': 'Harkins', 'Affiliation': 'Dermatology Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD 20892, USA.'}, {'ForeName': 'Nicole H', 'Initials': 'NH', 'LastName': 'Schwardt', 'Affiliation': 'Dermatology Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD 20892, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Portillo', 'Affiliation': 'Dermatology Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD 20892, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'NIH Intramural Sequencing Center, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD 20892, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Zimmerman', 'Affiliation': 'Center for Discovery and Innovation, Hackensack Meridian Health, Nutley, NJ 07110, USA.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Carter', 'Affiliation': 'Center for Discovery and Innovation, Hackensack Meridian Health, Nutley, NJ 07110, USA.'}, {'ForeName': 'Md Amir', 'Initials': 'MA', 'LastName': 'Hossen', 'Affiliation': 'Center for Discovery and Innovation, Hackensack Meridian Health, Nutley, NJ 07110, USA.'}, {'ForeName': 'Cody J', 'Initials': 'CJ', 'LastName': 'Peer', 'Affiliation': 'Clinical Pharmacology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Polley', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD 20850, USA.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Dartois', 'Affiliation': 'Center for Discovery and Innovation, Hackensack Meridian Health, Nutley, NJ 07110, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Figg', 'Affiliation': 'Clinical Pharmacology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA.'}, {'ForeName': 'Niki M', 'Initials': 'NM', 'LastName': 'Moutsopoulos', 'Affiliation': 'National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, MD 20892, USA.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Segre', 'Affiliation': 'Microbial Genomics Section, Translational and Functional Genomics Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD 20892, USA.'}, {'ForeName': 'Heidi H', 'Initials': 'HH', 'LastName': 'Kong', 'Affiliation': 'Dermatology Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD 20892, USA.'}]",Science translational medicine,['10.1126/scitranslmed.abd8077']
2981,34985973,GABA B  receptor modulation of visual sensory processing in adults with and without autism spectrum disorder.,"Sensory atypicalities in autism spectrum disorder (ASD) are thought to arise at least partly from differences in γ-aminobutyric acid (GABA) receptor function. However, the evidence to date has been indirect, arising from correlational studies in patients and preclinical models. Here, we evaluated the role of GABA receptor directly, in 44 adults ( n  = 19 ASD). Baseline concentration of occipital lobe GABA+ (GABA plus coedited macromolecules) was measured using proton magnetic resonance spectroscopy ( 1 H-MRS). Steady-state visual evoked potential (SSVEP) elicited by a passive visual surround suppression paradigm was compared after double-blind randomized oral administration of placebo or 15 to 30 mg of arbaclofen (STX209), a GABA type B (GABA B ) receptor agonist. In the placebo condition, the neurotypical SSVEP response was affected by both the foreground stimuli contrast and background interference (suppression). In ASD, however, all stimuli conditions had equal salience and background suppression of the foreground response was weaker. In the placebo condition, although there was no difference in GABA+ between groups, GABA+ concentration positively correlated with response to maximum foreground contrast during maximum background interference in neurotypicals, but not ASD. In neurotypicals, sensitivity to visual stimuli was disrupted by 30 mg of arbaclofen, whereas in ASD, it was made more “typical” and visual processing differences were abolished. Hence, differences in GABAergic function are fundamental to autistic (visual) sensory neurobiology and are modulated by GABA B  activity.",2022,"In the placebo condition, although there was no difference in GABA+ between groups, GABA+ concentration positively correlated with response to maximum foreground contrast during maximum background interference in neurotypicals, but not ASD.","['autism spectrum disorder (ASD', 'adults with and without autism spectrum disorder', '44 adults ( n  = 19 ASD']","['Steady-state visual evoked potential (SSVEP', 'arbaclofen (STX209), a GABA type B (GABA B ) receptor agonist', 'GABA B  receptor modulation', 'placebo']","['GABA+ concentration', 'Baseline concentration of occipital lobe GABA+ (GABA plus coedited macromolecules', 'sensitivity to visual stimuli', 'neurotypical SSVEP response', 'GABA']","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015217', 'cui_str': 'Visual evoked potential'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0052887', 'cui_str': 'GABA-B Receptor'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0028785', 'cui_str': 'Occipital lobe structure'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",44.0,0.204237,"In the placebo condition, although there was no difference in GABA+ between groups, GABA+ concentration positively correlated with response to maximum foreground contrast during maximum background interference in neurotypicals, but not ASD.","[{'ForeName': 'Qiyun', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Andreia C', 'Initials': 'AC', 'LastName': 'Pereira', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Hester', 'Initials': 'H', 'LastName': 'Velthuis', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Nichol M L', 'Initials': 'NML', 'LastName': 'Wong', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Ellis', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Francesca M', 'Initials': 'FM', 'LastName': 'Ponteduro', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Mihail', 'Initials': 'M', 'LastName': 'Dimitrov', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Kowalewski', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lythgoe', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Rotaru', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Richard A E', 'Initials': 'RAE', 'LastName': 'Edden', 'Affiliation': 'Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Leonard', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Glynis', 'Initials': 'G', 'LastName': 'Ivin', 'Affiliation': 'South London and Maudsley NHS Foundation Trust Pharmacy, London SE5 8AZ, UK.'}, {'ForeName': 'Jumana', 'Initials': 'J', 'LastName': 'Ahmad', 'Affiliation': 'School of Human Sciences, University of Greenwich, London SE10 9LS, UK.'}, {'ForeName': 'Charlotte M', 'Initials': 'CM', 'LastName': 'Pretzsch', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Declan G M', 'Initials': 'DGM', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'Gráinne M', 'Initials': 'GM', 'LastName': 'McAlonan', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 8AF, UK.""}]",Science translational medicine,['10.1126/scitranslmed.abg7859']
2982,35013427,Expression of type I interferon-associated genes at antiretroviral therapy interruption predicts HIV virological rebound.,"Although certain individuals with HIV infection can stop antiretroviral therapy (ART) without viral load rebound, the mechanisms under-pinning 'post-treatment control' remain unclear. Using RNA-Seq we explored CD4 T cell gene expression to identify evidence of a mechanism that might underpin virological rebound and lead to discovery of associated biomarkers. Fourteen female participants who received 12 months of ART starting from primary HIV infection were sampled at the time of stopping therapy. Two analysis methods (Differential Gene Expression with Gene Set Enrichment Analysis, and Weighted Gene Co-expression Network Analysis) were employed to interrogate CD4+ T cell gene expression data and study pathways enriched in post-treatment controllers versus early rebounders. Using independent analysis tools, expression of genes associated with type I interferon responses were associated with a delayed time to viral rebound following treatment interruption (TI). Expression of four genes identified by Cox-Lasso (ISG15, XAF1, TRIM25 and USP18) was converted to a Risk Score, which associated with rebound (p < 0.01). These data link transcriptomic signatures associated with innate immunity with control following stopping ART. The results from this small sample need to be confirmed in larger trials, but could help define strategies for new therapies and identify new biomarkers for remission.",2022,"Using independent analysis tools, expression of genes associated with type I interferon responses were associated with a delayed time to viral rebound following treatment interruption (TI).",['Fourteen female participants who received 12\xa0months of ART starting from primary HIV infection'],[],[],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1142553', 'cui_str': 'Primary HIV infection'}]",[],[],14.0,0.293241,"Using independent analysis tools, expression of genes associated with type I interferon responses were associated with a delayed time to viral rebound following treatment interruption (TI).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zacharopoulou', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Marchi', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ogbe', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Robinson', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Parolini', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pace', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Grayson', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kaleebu', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute, Entebbe, Uganda.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rees', 'Affiliation': 'Wits Reproductive Health and HIV Institute of the University of the Witwatersrand in Johannesburg, Johannesburg, South Africa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'Division of Medicine, Wright Fleming Institute, Imperial College, London, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Goulder', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Klenerman', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Frater', 'Affiliation': 'Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, UK. john.frater@ndm.ox.ac.uk.'}]",Scientific reports,['10.1038/s41598-021-04212-9']
2983,35142532,Autonomic function and its relationship with central obesity and hemodynamic variables in obese and overweight adults,"INTRODUCTION


central obesity is associated with an autonomic dysfunction characterized by an increase in sympathetic activity and a reduction in vagal tone, leading to a decrease in heart rate variability.
OBJECTIVE


we aimed to analyze the relationship between the time and frequency domains of heart rate variability with central obesity, and its hemodynamic variables in normal-weight, overweight and obese adults.
METHODS


a total of 65 adults were evaluated (25.4 ± 3.2 years old) and distributed in 3 groups: normal weight group (NW group), overweight group (OW group) and obese group (OB group). Heart rate variability parameters at rest and both anthropometric and hemodynamic variables were recorded.
RESULTS


the results showed a positive correlation between waist circunference and LF/HF ratio in the OW (p = 0.0008; r = 0.6607; r2 = 0.4365) and OB (p = 0.0001; r = 0.8286; r2 = 0.6866) groups. The waist-to-height ratio showed significant differences with HF in the NW, OW, and OB groups. The variables related to the parasympathetic system (SDNN, RMSSD, pNN50, HF) in the OB and OW groups showed a decrease in values when compared to the NW group. Likewise, the variable related to the sympathetic system (LF) in the OB and OW groups increased its values when compared with the NW group. The LF/HF ratio increased from the NW group to the OW and OB groups (1.6 ± 0.7; 2.5 ± 1.8 and 3.3 ± 0.7).
CONCLUSION


overweight and obese adults present a modulation of sympathetic activity predominance at rest. This increased activity is represented by the time and frequency domains of heart rate variability, having an important correlation with waist circumference and waist-to-height ratio.",2022,"The variables related to the parasympathetic system (SDNN, RMSSD, pNN50, HF) in the OB and OW groups showed a decrease in values when compared to the NW group.","['normal-weight, overweight and obese adults', 'obese and overweight adults', 'a total of 65 adults were evaluated (25.4 ± 3.2 years old) and distributed in 3 groups: normal weight group (NW group), overweight group (OW group) and obese group (OB group', 'overweight and obese adults']",[],"['sympathetic activity', 'waist circunference and LF/HF ratio', 'Autonomic function', 'parasympathetic system (SDNN, RMSSD, pNN50, HF', 'OB', 'LF/HF ratio']","[{'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",65.0,0.0528589,"The variables related to the parasympathetic system (SDNN, RMSSD, pNN50, HF) in the OB and OW groups showed a decrease in values when compared to the NW group.","[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Espinoza-Salinas', 'Affiliation': 'Exercise Physiology Laboratory. Escuela de Kinesiología. Universidad Santo Tomás.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Brito', 'Affiliation': 'Department of Physical Education. Universidade Federal de Juiz de Fora.'}, {'ForeName': 'Giovanny', 'Initials': 'G', 'LastName': 'Arenas Sánchez', 'Affiliation': 'Exercise Physiology Laboratory. Escuela de Kinesiología. Universidad Santo Tomás.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Peiret Villacura', 'Affiliation': 'Facultad de Ciencias Médicas. Universidad de Santiago de Chile.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Molina Sotomayor', 'Affiliation': 'Departamento de Educación Física. Universidad Metropolitana de Ciencias de la Educación.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Cigarroa Cuevas', 'Affiliation': 'Exercise Physiology Laboratory. Escuela de Kinesiología. Universidad Santo Tomás.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'González-Jurado', 'Affiliation': 'Facultad de Ciencias Médicas. Universidad Pablo de Olavide de Sevilla.'}]",Nutricion hospitalaria,['10.20960/nh.03808']
2984,35235774,The NADPARK study: A randomized phase I trial of nicotinamide riboside supplementation in Parkinson's disease.,"We conducted a double-blinded phase I clinical trial to establish whether nicotinamide adenine dinucleotide (NAD) replenishment therapy, via oral intake of nicotinamide riboside (NR), is safe, augments cerebral NAD levels, and impacts cerebral metabolism in Parkinson's disease (PD). Thirty newly diagnosed, treatment-naive patients received 1,000 mg NR or placebo for 30 days. NR treatment was well tolerated and led to a significant, but variable, increase in cerebral NAD levels-measured by  31 phosphorous magnetic resonance spectroscopy-and related metabolites in the cerebrospinal fluid. NR recipients showing increased brain NAD levels exhibited altered cerebral metabolism, measured by  18 fluoro-deoxyglucose positron emission tomography, and this was associated with mild clinical improvement. NR augmented the NAD metabolome and induced transcriptional upregulation of processes related to mitochondrial, lysosomal, and proteasomal function in blood cells and/or skeletal muscle. Furthermore, NR decreased the levels of inflammatory cytokines in serum and cerebrospinal fluid. Our findings nominate NR as a potential neuroprotective therapy for PD, warranting further investigation in larger trials.",2022,"NR recipients showing increased brain NAD levels exhibited altered cerebral metabolism, measured by  18 fluoro-deoxyglucose positron emission tomography, and this was associated with mild clinical improvement.","[""Parkinson's disease"", ""Parkinson's disease (PD""]","['nicotinamide adenine dinucleotide (NAD) replenishment therapy, via oral intake of nicotinamide riboside (NR', 'placebo', 'nicotinamide riboside supplementation']","['cerebral NAD levels', 'levels of inflammatory cytokines in serum and cerebrospinal fluid', 'brain NAD levels exhibited altered cerebral metabolism']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0068711', 'cui_str': 'nicotinamide-beta-riboside'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.243884,"NR recipients showing increased brain NAD levels exhibited altered cerebral metabolism, measured by  18 fluoro-deoxyglucose positron emission tomography, and this was associated with mild clinical improvement.","[{'ForeName': 'Brage', 'Initials': 'B', 'LastName': 'Brakedal', 'Affiliation': 'Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dölle', 'Affiliation': 'Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Riemer', 'Affiliation': 'Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Mohn Medical Imaging and Visualization Centre (MMIV), Department of Radiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Center for Neurosciences, Institute of Molecular Medicine, The Feinstein Institutes for Medical Research, Manhasset, NY, USA.'}, {'ForeName': 'Gonzalo S', 'Initials': 'GS', 'LastName': 'Nido', 'Affiliation': 'Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Geir Olve', 'Initials': 'GO', 'LastName': 'Skeie', 'Affiliation': 'Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Craven', 'Affiliation': 'Mohn Medical Imaging and Visualization Centre (MMIV), Department of Radiology, Haukeland University Hospital, Bergen, Norway; Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway; Department of Clinical Engineering, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schwarzlmüller', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway; Department of Radiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Njål', 'Initials': 'N', 'LastName': 'Brekke', 'Affiliation': 'Mohn Medical Imaging and Visualization Centre (MMIV), Department of Radiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Diab', 'Affiliation': 'Department of Biomedicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Sverkeli', 'Affiliation': 'Department of Biomedicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Skjeie', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Varhaug', 'Affiliation': 'Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Ole-Bjørn', 'Initials': 'OB', 'LastName': 'Tysnes', 'Affiliation': 'Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Shichun', 'Initials': 'S', 'LastName': 'Peng', 'Affiliation': 'Center for Neurosciences, Institute of Molecular Medicine, The Feinstein Institutes for Medical Research, Manhasset, NY, USA.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Haugarvoll', 'Affiliation': 'Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ziegler', 'Affiliation': 'Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Biomedicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Grüner', 'Affiliation': 'Mohn Medical Imaging and Visualization Centre (MMIV), Department of Radiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Eidelberg', 'Affiliation': 'Center for Neurosciences, Institute of Molecular Medicine, The Feinstein Institutes for Medical Research, Manhasset, NY, USA.'}, {'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Tzoulis', 'Affiliation': 'Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway. Electronic address: charalampos.tzoulis@uib.no.'}]",Cell metabolism,['10.1016/j.cmet.2022.02.001']
2985,35235726,Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants.,"BACKGROUND


Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infection and hospitalization in infants. Nirsevimab is a monoclonal antibody to the RSV fusion protein that has an extended half-life. The efficacy and safety of nirsevimab in healthy late-preterm and term infants are uncertain.
METHODS


We randomly assigned, in a 2:1 ratio, infants who had been born at a gestational age of at least 35 weeks to receive a single intramuscular injection of nirsevimab or placebo before the start of an RSV season. The primary efficacy end point was medically attended RSV-associated lower respiratory tract infection through 150 days after the injection. The secondary efficacy end point was hospitalization for RSV-associated lower respiratory tract infection through 150 days after the injection.
RESULTS


A total of 1490 infants underwent randomization: 994 were assigned to the nirsevimab group and 496 to the placebo group. Medically attended RSV-associated lower respiratory tract infection occurred in 12 infants (1.2%) in the nirsevimab group and in 25 infants (5.0%) in the placebo group; these findings correspond to an efficacy of 74.5% (95% confidence interval [CI], 49.6 to 87.1; P<0.001) for nirsevimab. Hospitalization for RSV-associated lower respiratory tract infection occurred in 6 infants (0.6%) in the nirsevimab group and in 8 infants (1.6%) in the placebo group (efficacy, 62.1%; 95% CI, -8.6 to 86.8; P = 0.07). Among infants with data available to day 361, antidrug antibodies after baseline were detected in 58 of 951 (6.1%) in the nirsevimab group and in 5 of 473 (1.1%) in the placebo group. Serious adverse events were reported in 67 of 987 infants (6.8%) who received nirsevimab and in 36 of 491 infants (7.3%) who received placebo.
CONCLUSIONS


A single injection of nirsevimab administered before the RSV season protected healthy late-preterm and term infants from medically attended RSV-associated lower respiratory tract infection. (Funded by MedImmune/AstraZeneca and Sanofi; MELODY ClinicalTrials.gov number, NCT03979313.).",2022,"Serious adverse events were reported in 67 of 987 infants (6.8%) who received nirsevimab and in 36 of 491 infants (7.3%) who received placebo.
","['Healthy Late-Preterm and Term Infants', 'healthy late-preterm and term infants', 'infants who had been born at a gestational age of at least 35 weeks to receive a', '1490 infants underwent randomization', 'infants']","['Nirsevimab', 'nirsevimab', 'placebo', 'single intramuscular injection of nirsevimab or placebo']","['Hospitalization for RSV-associated lower respiratory tract infection', 'efficacy and safety', 'Serious adverse events', 'respiratory tract infection', 'hospitalization for RSV-associated lower respiratory tract infection', 'medically attended RSV-associated lower respiratory tract infection']","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]",1490.0,0.456888,"Serious adverse events were reported in 67 of 987 infants (6.8%) who received nirsevimab and in 36 of 491 infants (7.3%) who received placebo.
","[{'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Hammitt', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Dagan', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Baca Cots', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'Miroslava', 'Initials': 'M', 'LastName': 'Bosheva', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Muller', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Zar', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Brooks', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Grenham', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Wählby Hamrén', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'Vaishali S', 'Initials': 'VS', 'LastName': 'Mankad', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Ren', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Takas', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Abram', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Leach', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'M Pamela', 'Initials': 'MP', 'LastName': 'Griffin', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Villafana', 'Affiliation': ""From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2110275']
2986,35235720,Effects of Brexpiprazole on Functioning in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies.,"
Objective:  To evaluate the short- and long-term effects of brexpiprazole on patient functioning in schizophrenia.
Methods:  Data were included from three 6-week, randomized, double-blind, placebo-controlled studies (hospitalized patients); a 52-week, randomized, double-blind, placebo-controlled maintenance treatment study (terminated early by the study sponsor based on the positive result of an interim analysis); and two 52-week, open-label extension studies-all in patients with schizophrenia ( DSM-IV-TR  criteria) and conducted from July 2011-February 2016. Patients allocated to oral brexpiprazole received 2-4 mg/d (short-term studies) or 1-4 mg/d (long-term studies). Functioning was measured using the Personal and Social Performance (PSP) and Global Assessment of Functioning (GAF) scales, with response defined as a PSP/GAF increase of ≥ 10 points and remission as PSP score ≥ 71 or GAF score ≥ 61.
Results:  Patients receiving brexpiprazole (n = 831) showed greater improvement than those receiving placebo (n = 490) from baseline to week 6 in PSP score (least squares mean difference, 3.20; 95% confidence interval, 1.82-4.58;  P  < .0001; Cohen  d  = 0.31) and in all 4 PSP domains. At week 52 of the maintenance study (which had a low completion rate primarily due to the early termination), GAF functional remission was achieved by 65.3% (62/95) of stabilized patients randomized to brexpiprazole and 47.1% (48/102) of stabilized patients randomized to placebo, with a number needed to treat of 6 (95% confidence interval, 4-22;  P  = .0076). At week 52 of the open-label studies (n = 177), PSP functional response and remission were achieved by 84.2% and 41.8% of patients receiving brexpiprazole, respectively.
Conclusions:  Although limited by the lack of an active comparator, analyses of this large dataset demonstrate that brexpiprazole treatment is associated with clinically relevant improvement in functioning among patients with schizophrenia, in the short term and long term.
Trial Registration:  Data used in this post hoc analysis were from studies with ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380, NCT01668797, NCT01397786, and NCT01810783.",2022,"Results:  Patients receiving brexpiprazole (n = 831) showed greater improvement than those receiving placebo (n = 490) from baseline to week 6 in PSP score (least squares mean difference, 3.20; 95% confidence interval, 1.82-4.58;  P  < .0001; Cohen  d  = 0.31) and in all 4 PSP domains.","['patients with schizophrenia', 'Patients With Schizophrenia', 'patient functioning in schizophrenia', 'controlled studies (hospitalized patients', 'patients with schizophrenia ( DSM-IV-TR  criteria) and conducted from July 2011-February 2016']","['brexpiprazole', 'oral brexpiprazole', 'Brexpiprazole', 'placebo']","['PSP functional response and remission', 'GAF functional remission', 'PSP score', 'Personal and Social Performance (PSP) and Global Assessment of Functioning (GAF) scales, with response defined as a PSP/GAF increase of ≥\u200910 points and remission as PSP score ≥\u200971 or GAF score ≥\u200961']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038868', 'cui_str': 'Progressive supranuclear palsy'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1565805', 'cui_str': 'FGF9 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.453658,"Results:  Patients receiving brexpiprazole (n = 831) showed greater improvement than those receiving placebo (n = 490) from baseline to week 6 in PSP score (least squares mean difference, 3.20; 95% confidence interval, 1.82-4.58;  P  < .0001; Cohen  d  = 0.31) and in all 4 PSP domains.","[{'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'The Zucker Hillside Hospital, Department of Psychiatry, Glen Oaks, New York.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Therrien', 'Affiliation': 'Otsuka Canada Pharmaceutical Inc, Saint-Laurent, Quebec, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'MacKenzie', 'Affiliation': 'Lundbeck Canada Inc, Saint-Laurent, Quebec, Canada.'}, {'ForeName': 'Stine R', 'Initials': 'SR', 'LastName': 'Meehan', 'Affiliation': 'H. Lundbeck A/S, Valby, Copenhagen, Denmark.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Weiss', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey.'}, {'ForeName': 'Nanco', 'Initials': 'N', 'LastName': 'Hefting', 'Affiliation': 'H. Lundbeck A/S, Valby, Copenhagen, Denmark.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hobart', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey.'}]",The Journal of clinical psychiatry,['10.4088/JCP.20m13793']
2987,35236137,Comparison of Four Classroom-Based Strategies for Middle School Students With ADHD: A Pilot Randomized Controlled Trial.,"Middle school students with ADHD often experience negative academic outcomes. To intervene, schools frequently provide services through special education or section 504. These services include strategies, such as breaks, prompting, and sensory proprioception to remove the impact of construct-irrelevant variance. Student plans rarely include strategies, such as selfmanagement, designed to teach students skills to increase independent functioning. The purpose of this study was to compare the effectiveness of four strategies on engagement, disruptive behavior, and time to initiate tasks. Fifteen sixth and seventh grade students were randomized daily to one of four conditions. Results indicated large statistically significant differences. Social validity data indicated that students found prompting and self-management helpful, but preferred breaks and sensory proprioception. This study builds on a growing empirical base that supports the prioritization of strategies to teach skills over strategies to remove the impact of ADHD on performance.",2022,"Social validity data indicated that students found prompting and self-management helpful, but preferred breaks and sensory proprioception.","['Middle school students with ADHD often experience negative academic outcomes', 'Fifteen sixth and seventh grade students', 'Middle School Students With ADHD']",['Four Classroom-Based Strategies'],"['engagement, disruptive behavior, and time to initiate tasks']","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.021101,"Social validity data indicated that students found prompting and self-management helpful, but preferred breaks and sensory proprioception.","[{'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Harrison', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, USA.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Evans', 'Affiliation': 'Ohio University, Athens, USA.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Zatz', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, USA.'}, {'ForeName': 'Paulomi', 'Initials': 'P', 'LastName': 'Mehta', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, USA.'}, {'ForeName': 'Aayushi', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, USA.'}, {'ForeName': 'Muzzammil', 'Initials': 'M', 'LastName': 'Syed', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, USA.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Soares', 'Affiliation': 'University of Mississippi, University Park, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Swistack', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Griffith', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Custer', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, USA.'}]",Journal of attention disorders,['10.1177/10870547221081108']
2988,35236061,[Transcranial magnet therapy in comprehensive therapy of migraine].,"Migraine is a primary form of headache characterized by throbbing unilateral attacks, increased sensitivity to light and sound, accompanied by nausea and/or vomiting, lasting from 4 hours to 3 days. Developing and implementing new methods of pain relief is an urgent task of modern medicine. One of the safest and most commonly recommended methods is transcranial magnet therapy (TMT).
OBJECTIVE


To evaluate the effect of TMT on improving the effectiveness of comprehensive therapy in patients with migraine.
MATERIAL AND METHODS


A blind, randomized, placebo-controlled clinical trial was conducted, including 50 patients with migraine divided into three groups (the main group received TMT; the comparison group received low-frequency magnet therapy with a magnetic pulse duration of 250 μs; the control group received treatment with placebo device). The objectives were to study the TMT effect on reduction of the frequency and intensity of headache attacks, the severity of associated symptoms, reduction of medications use, including analgesics, in patients with migraine, as well as to evaluate the statistical difference in the effectiveness of magnetic therapy with different magnetic pulse ratio on all of the above parameters in study patients.
RESULTS


According to the study data, a positive effect of TMT on the patients' condition was observed. After treatment, 76.9% of the patients in the main group had a reduction of headache intensity compared to the control group (35%) and a 47.8% decrease in analgesics use. In the main group, a reduction of nausea (73.3% of patients), acousticophobia (77.8% of patients), and photophobia (81.8% of patients) was noted. The HADS scale showed a 44.3% reduction in anxiety and depression in the main group.
CONCLUSION


The clinical efficacy of TMT in patients with migraine has been demonstrated. In clinical practice, it is reasonable to use TMT to improve the treatment effectiveness in patients with migraine.",2022,"In the main group, a reduction of nausea (73.3% of patients), acousticophobia (77.8% of patients), and photophobia (81.8% of patients) was noted.","['50 patients with migraine divided into three groups (the main group received', 'patients with migraine']","['placebo', 'transcranial magnet therapy (TMT', 'TMT; the comparison group received low-frequency magnet therapy with a magnetic pulse duration of 250 μs; the control group received treatment with placebo device', 'Transcranial magnet therapy', 'TMT']","['HADS scale', 'anxiety and depression', 'acousticophobia', 'reduction of nausea', 'frequency and intensity of headache attacks', 'headache intensity', 'photophobia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0024483', 'cui_str': 'Magnet'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0085636', 'cui_str': 'Photophobia'}]",50.0,0.0386462,"In the main group, a reduction of nausea (73.3% of patients), acousticophobia (77.8% of patients), and photophobia (81.8% of patients) was noted.","[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Bodrova', 'Affiliation': 'Kazan State Medical Academy - branch of the Russian Medical Academy of Continuing Professional Education, Kazan, Russia.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Karimova', 'Affiliation': 'Kazan State Medical Academy - branch of the Russian Medical Academy of Continuing Professional Education, Kazan, Russia.'}, {'ForeName': 'L Sh', 'Initials': 'LS', 'LastName': 'Gumarova', 'Affiliation': 'Kazan State Medical Academy - branch of the Russian Medical Academy of Continuing Professional Education, Kazan, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Askarova', 'Affiliation': 'Kazan State Medical Academy - branch of the Russian Medical Academy of Continuing Professional Education, Kazan, Russia.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Kuchumova', 'Affiliation': 'Kazan State Medical Academy - branch of the Russian Medical Academy of Continuing Professional Education, Kazan, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20229901113']
2989,35235993,Telehealth Education via WeChat Improves the Quality of Life of Parents of Children with Type-1 Diabetes Mellitus.,"OBJECTIVE


The purpose of this study was to explore the effect of telehealth education and care guidance via WeChat (Tencent Ltd., Shenzhen, China; a popular smartphone-based social media application) on improving the quality of life of parents of children with type-1 diabetes mellitus.
METHODS


A prospective randomized controlled study was conducted in our hospital from March 2019 to September 2020 to compare the quality of life of parents of children with type-1 diabetes mellitus in the intervention group and the control group.
RESULTS


Six months after discharge, the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) scores of parents in the intervention group were significantly lower than those in the control group ( p  < 0.05). Compared with the SAS and SDS scores at discharge time, those scores of parents at 6 months after discharge time in intervention group were significantly lower ( p  < 0.05), while those scores of parents at 6 months after discharge time in control was similar ( p  > 0.05). Six months after discharge, the scores of the physiological field, psychological field, social relationship field, and environmental field in the intervention group were significantly higher than those of the control group according to the result of the World Health Organization Quality of Life Brief Scale (WHOQOL-BREF;  p  < 0.05).
CONCLUSION


Using WeChat to provide telehealth education and home care guidance to the parents of children with type-1 diabetes mellitus can effectively relieve the anxiety and depression of the parents and improve their quality of life.",2022,Using WeChat to provide telehealth education and home care guidance to the parents of children with type-1 diabetes mellitus can effectively relieve the anxiety and depression of the parents and improve their quality of life.,"['Parents of Children with Type-1 Diabetes Mellitus', 'parents of children with type-1 diabetes mellitus in the intervention group and the control group', 'parents of children with type-1 diabetes mellitus']","['WeChat', 'telehealth education and care guidance via WeChat (Tencent Ltd., Shenzhen, China; a popular smartphone-based social media application']","['scores of the physiological field, psychological field, social relationship field, and environmental field', 'World Health Organization Quality of Life Brief Scale', 'Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) scores of parents', 'Quality of Life', 'quality of life']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C1136140', 'cui_str': 'Long-Term Depression, Neurophysiologic'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",,0.00692211,Using WeChat to provide telehealth education and home care guidance to the parents of children with type-1 diabetes mellitus can effectively relieve the anxiety and depression of the parents and improve their quality of life.,"[{'ForeName': 'Mei-Xia', 'Initials': 'MX', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian Province, China.'}, {'ForeName': 'Mei-Chun', 'Initials': 'MC', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian Province, China.'}, {'ForeName': 'Bi-Yu', 'Initials': 'BY', 'LastName': 'Wu', 'Affiliation': 'Department of Pediatrics, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian Province, China.'}]",Applied clinical informatics,['10.1055/s-0042-1743239']
2990,35236444,RETRACTED ARTICLE: Patelloplasty in total knee arthroplasty with circumpatellar denervation versus without denervation - a randomized prospective study.,"INTRODUCTION


Anterior knee pain is one of the major problems in total knee arthroplasty (TKA) and is often etiologically associated with a patellofemoral parts etiology. There is no consensus as to etiology or treatment. Denervation of the patella by electrocautery and patelloplasty along with removal of osteophytes have been used for treatment of anterior knee pain in TKA. The purpose of our study was to compare, in terms of the anterior knee pain and clinical outcomes of patelloplasty in total knee arthroplasty (TKA), patellar denervation by electrocautery and non-patellar-denervation treatment in a 2 year follow-up.
MATERIALS AND METHODS


This study was conducted in a total of 108 patients, who underwent TKA at our institution between June 2015 and December 2016. Patients age 55 to 80 years, who are suffering from osteoarthritis, rheumatoid arthritis of knee were included in this study. Patients were randomly allocated into patelloplasty with denervation group and non-denervation group. The denervation of the patella was done in electrocautery group using a monopolar coagulation diathermy set to 50 W. (Valleylab Inc., Boulder, CO). Postoperatively, patients were assessed at regular intervals of 3, 6, 9, 12, 24 months. To assess patient outcomes, we used questionnaires to determine the Knee Society score (KSS - knee and function scores), a specific patellofemoral pain questionnaire (Kujala score) range of motion (ROM) and a visual analogue scale (VAS) to assess anterior knee pain.
RESULTS


The data obtained were analyzed using SPSS version 17.0. Continuous variables were expressed as mean ± SD. Of the 108 patients, 9 patients were lost to follow-up. Among the remaining 99 patients, 50 were included in denervation group and 49 in non-denervation group. In our study, there was no statistically significant difference in Mean KUJALA score preoperatively (p > 0.05). Postoperatively, the mean KUJALA score was significantly higher in denervation group at 3, 6, 9, 12, 24 months of follow-up when compared to TKR with no denervation (p < 0.05). There was no statistically significant difference in Mean VAS score preoperatively (p > 0.05). However, 6, 12 and 24 months after the operation, the mean VAS score was significantly lower in denervation group. There was no statistically significant difference in Mean KSS score preoperatively and postoperatively (p > 0.05). The mean ROM was significantly higher in denervation group than in the group of TKR with no denervation (p < 0.05).
CONCLUSION


In our study, less postoperative anterior knee pain, increased range of motion, significantly lower VAS scores were seen in the denervation group compared with non-denervation group. Circumferential denervation of patella during primary TKA along with patellar resurfacing is a safe procedure that improves patient satisfaction, decreases anterior knee pain and improves range of flexion in the postoperative period and at postoperative follow-ups.",2020,"However, 6, 12 and 24 months after the operation, the mean VAS score was significantly lower in denervation group.","['108 patients, who underwent TKA at our institution between June 2015 and December 2016', 'total knee arthroplasty with circumpatellar denervation versus without denervation ', 'anterior knee pain in TKA', '108 patients, 9 patients were lost to follow-up', 'Patients age 55 to 80\u2009years, who are suffering from osteoarthritis, rheumatoid arthritis of knee']","['patellar resurfacing', 'monopolar coagulation diathermy', 'patelloplasty with denervation group and non-denervation group', 'patelloplasty in total knee arthroplasty (TKA), patellar denervation by electrocautery and non-patellar-denervation\xa0treatment']","['mean ROM', 'mean VAS score', 'Knee Society score (KSS - knee and function scores), a specific patellofemoral pain questionnaire (Kujala score) range of motion (ROM) and a visual analogue scale (VAS) to assess anterior knee pain', 'patient satisfaction, decreases anterior knee pain and improves range of flexion', 'mean KUJALA score', 'Mean VAS score', 'Mean KSS score', 'postoperative anterior knee pain, increased range of motion, significantly lower VAS scores']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0011307', 'cui_str': 'Denervation - action'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0409637', 'cui_str': 'Rheumatoid arthritis of knee'}]","[{'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0011307', 'cui_str': 'Denervation - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",9.0,0.0229323,"However, 6, 12 and 24 months after the operation, the mean VAS score was significantly lower in denervation group.","[{'ForeName': 'S R K', 'Initials': 'SRK', 'LastName': 'Deekshith', 'Affiliation': 'Department of Orthopedics, SVS Medical College and Hospital, Mahabubnagar, Telangana State, 500062, India. srkdikshith@gmail.com.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Reddy', 'Affiliation': 'Department of Orthopedics, SVS Medical College and Hospital, Mahabubnagar, Telangana State, 500062, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Raviteja', 'Affiliation': 'Department of Orthopedics, SVS Medical College and Hospital, Mahabubnagar, Telangana State, 500062, India.'}]","Arthroplasty (London, England)",['10.1186/s42836-020-00044-6']
2991,35236439,A prospective comparative study of local infiltration versus adductor block versus combined use of the two techniques following knee arthroplasty.,"BACKGROUND


Pain management after total knee arthroplasty (TKA) is important as acute postoperative pain can affect patient's ability to walk and participate in rehabilitation required for good functional outcome. This is achieved by effective intra-operative and post-operative analgesia to facilitate early recovery. Adductor canal block (ACB) and local infiltration analgesia (LIA) are analgesic regimens and commonly used for effective post-operative analgesia after TKA. Our aim was to compare the efficacy and outcomes of these two methods, combined and independently.
METHODS


Our study included 120 patients undergoing unilateral TKA, who were randomized into three groups: LIA (Group I), ACB (Group II) and combined LIA + ACB (Group III). Patients were operated by a single surgeon. The outcome was defined by post-operative analgesia achieved by the three techniques (measured by the NPRS) and amount of fentanyl consumed postoperatively. Secondary outcome was evaluated based on postoperative functional outcomes in terms of ability to stand, distance covered, range of motion of knee on the 1st post-operative day, complications and WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index) scores.
RESULTS


All patients were available for analysis. Numerical Pain Rating Scale for pain showed significant differences at 24 h between Group I and Group II, with a p value of 0.018 (GroupI was better), significant differences were found at 24 h between Group III and Group II, with p values being 0.023 and 0.004 (GroupIII was better). No significant differences were found between Group I and Group III at 24 h. Total fentanyl consumption was significantly less in Group III than in Group I and Group II, with p value being 0.042 and 0.005, respectively (Group III was better and consumed less fentanyl). No significant differences were found in WOMAC scores between the three groups at baseline, 2 and 6 weeks after operation.
CONCLUSION


In patients undergoing TKA, analgesic effect of combined ACB and LIA was superior, as indicated by reduced opioid consumption and no differences in functional outcomes and complications were observed as compared to separate use of the two techniques.",2020,"In patients undergoing TKA, analgesic effect of combined ACB and LIA was superior, as indicated by reduced opioid consumption and no differences in functional outcomes and complications were observed as compared to separate use of the two techniques.","['total knee arthroplasty (TKA', 'knee arthroplasty', '120 patients undergoing unilateral TKA']","['ACB (Group\xa0II) and combined LIA\u2009+\u2009ACB', 'local infiltration versus adductor block', 'LIA', 'Adductor canal block (ACB) and local infiltration analgesia (LIA']","['opioid consumption', 'postoperative functional outcomes in terms of ability to stand, distance covered, range of motion of knee on the\xa01st post-operative day, complications and WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index) scores', 'Numerical Pain Rating Scale for pain', 'WOMAC scores', 'post-operative analgesia', 'functional outcomes and complications', 'Total fentanyl consumption']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0560788', 'cui_str': 'Ability to stand'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]",120.0,0.029606,"In patients undergoing TKA, analgesic effect of combined ACB and LIA was superior, as indicated by reduced opioid consumption and no differences in functional outcomes and complications were observed as compared to separate use of the two techniques.","[{'ForeName': 'S K S', 'Initials': 'SKS', 'LastName': 'Marya', 'Affiliation': 'Bone & Joint Institute, Medanta, Medicity, H Baktawar Singh Road Sector 38, Gurugram, Haryana, India. sksmarya@yahoo.co.in.'}, {'ForeName': 'Deep', 'Initials': 'D', 'LastName': 'Arora', 'Affiliation': 'Bone & Joint Institute, Medanta, Medicity, H Baktawar Singh Road Sector 38, Gurugram, Haryana, India.'}, {'ForeName': 'Chandeep', 'Initials': 'C', 'LastName': 'Singh', 'Affiliation': 'Bone & Joint Institute, Medanta, Medicity, H Baktawar Singh Road Sector 38, Gurugram, Haryana, India.'}, {'ForeName': 'Shitij', 'Initials': 'S', 'LastName': 'Kacker', 'Affiliation': 'Bone & Joint Institute, Medanta, Medicity, H Baktawar Singh Road Sector 38, Gurugram, Haryana, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Desai', 'Affiliation': 'Bone & Joint Institute, Medanta, Medicity, H Baktawar Singh Road Sector 38, Gurugram, Haryana, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Lodha', 'Affiliation': 'Bone & Joint Institute, Medanta, Medicity, H Baktawar Singh Road Sector 38, Gurugram, Haryana, India.'}]","Arthroplasty (London, England)",['10.1186/s42836-020-00034-8']
2992,35236397,Study protocol for the Multimodal Approach to Preventing Suicide in Schools (MAPSS) project: a regionally based randomised trial of an integrated response to suicide risk among secondary school students.,"BACKGROUND


Suicide is the leading cause of death among young Australians, accounting for one-third of all deaths in those under 25. Schools are a logical setting for youth suicide prevention activities, with universal, selective and indicated approaches all demonstrating efficacy. Given that international best practice recommends suicide prevention programmes combine these approaches, and that to date this has not been done in school settings, this study aims to evaluate a suicide prevention programme incorporating universal, selective and indicated components in schools.
METHODS


This study is a trial of a multimodal suicide prevention programme for young people. The programme involves delivering universal psychoeducation (safeTALK) to all students, screening them for suicide risk, and delivering internet-based Cognitive Behavioural Therapy (Reframe IT) to those students identified as being at high risk for suicide. The programme will be trialled in secondary schools in Melbourne, Australia, and target year 10 students (15 and 16 year-olds). safeTALK and screening will be evaluated using a single group pre-test/post-test case series, and Reframe IT will be evaluated in a Randomised Controlled Trial. The primary outcome is change in suicidal ideation; other outcomes include help-seeking behaviour and intentions, and suicide knowledge and stigma. The programme's cost-effectiveness will also be evaluated.
DISCUSSION


This study is the first to evaluate a suicide prevention programme comprising universal, selective and indicated components in Australian schools. If the programme is found to be efficacious and cost-effective, it could be more widely disseminated in schools and may ultimately lead to reduced rates of suicide and suicidal behaviour in school students across the region.",2022,"The primary outcome is change in suicidal ideation; other outcomes include help-seeking behaviour and intentions, and suicide knowledge and stigma.","['secondary school students', 'secondary schools in Melbourne, Australia, and target year 10 students (15 and 16\u2009year-olds', 'Australian schools', 'young people']","['multimodal suicide prevention programme', 'universal psychoeducation (safeTALK) to all students, screening them for suicide risk, and delivering internet-based Cognitive Behavioural Therapy (Reframe IT']","['change in suicidal ideation; other outcomes include help-seeking behaviour and intentions, and suicide knowledge and stigma']","[{'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0204732', 'cui_str': 'Suicide prevention'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",,0.0924995,"The primary outcome is change in suicidal ideation; other outcomes include help-seeking behaviour and intentions, and suicide knowledge and stigma.","[{'ForeName': 'Sadhbh J', 'Initials': 'SJ', 'LastName': 'Byrne', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Bailey', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Lamblin', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'McKay', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Pirkis', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Deakin Health Economics, Institute for Health Transformation, School for Health and Social Development, Faculty of Health, Deakin University, Geelong, Australia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Spittal', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rice', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hetrick', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hamilton', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Hok Pan', 'Initials': 'HP', 'LastName': 'Yuen', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Yong Yi', 'Initials': 'YY', 'LastName': 'Lee', 'Affiliation': 'Deakin Health Economics, Institute for Health Transformation, School for Health and Social Development, Faculty of Health, Deakin University, Geelong, Australia.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Boland', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Orygen, Parkville, Australia. jo.robinson@orygen.org.au.'}]",Trials,['10.1186/s13063-022-06072-8']
2993,35236394,EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil.,"BACKGROUND


Arboviruses transmitted by Aedes aegypti including dengue, Zika, and chikungunya are a major global health problem, with over 2.5 billion at risk for dengue alone. There are no licensed antivirals for these infections, and safe and effective vaccines are not yet widely available. Thus, prevention of arbovirus transmission by vector modification is a novel approach being pursued by multiple researchers. However, the field needs high-quality evidence derived from randomized, controlled trials upon which to base the implementation and maintenance of vector control programs. Here, we report the EVITA Dengue trial design (DMID 17-0111), which assesses the efficacy in decreasing arbovirus transmission of an innovative approach developed by the World Mosquito Program for vector modification of Aedes mosquitoes by Wolbachia pipientis.
METHODS


DMID 17-0111 is a cluster-randomized trial in Belo Horizonte, Brazil, with clusters defined by primary school catchment areas. Clusters (n = 58) will be randomized 1:1 to intervention (release of Wolbachia-infected Aedes aegypti mosquitoes) vs. control (no release). Standard vector control activities (i.e., insecticides and education campaigns for reduction of mosquito breeding sites) will continue as per current practice in the municipality. Participants (n = 3480, 60 per cluster) are children aged 6-11 years enrolled in the cluster-defining school and living within the cluster boundaries who will undergo annual serologic surveillance for arboviral infection. The primary objective is to compare sero-incidence of arboviral infection between arms.
DISCUSSION


DMID 17-0111 aims to determine the efficacy of Wolbachia-infected mosquito releases in reducing human infections by arboviruses transmitted by Aedes aegypti and will complement the mounting evidence for this method from large-scale field releases and ongoing trials. The trial also represents a critical step towards robustness and rigor for how vector control methods are assessed, including the simultaneous measurement and correlation of entomologic and epidemiologic outcomes. Data from this trial will inform further the development of novel vector control methods.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04514107 . Registered on 17 August 2020 Primary sponsor: National Institute of Health, National Institute of Allergy and Infectious Diseases.",2022,"BACKGROUND


Arboviruses transmitted by Aedes aegypti including dengue, Zika, and chikungunya are a major global health problem, with over 2.5 billion at risk for dengue alone.","['Registered on 17 August 2020', 'Participants (n = 3480, 60 per cluster) are children aged 6-11\u2009years enrolled in the cluster-defining school and living within the cluster boundaries who will undergo annual serologic surveillance for arboviral infection', 'DMID 17-0111 is a cluster-randomized trial in Belo Horizonte, Brazil, with clusters defined by primary school catchment areas', 'Arboviral infection in Brazil']","['Wolbachia-InfecTed Aedes aegypti mosquitoes', 'Standard vector control activities (i.e., insecticides and education campaigns']",[],"[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C1963805', 'cui_str': 'Arboviral infection'}, {'cui': 'C0635282', 'cui_str': '2-(2,4-dimethylphenyl)indan-1,3-dione'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}]","[{'cui': 'C0752001', 'cui_str': 'Wolbachia'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0026584', 'cui_str': 'Family Culicidae'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031249', 'cui_str': 'Pest control'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021576', 'cui_str': 'Insecticide'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],58.0,0.248987,"BACKGROUND


Arboviruses transmitted by Aedes aegypti including dengue, Zika, and chikungunya are a major global health problem, with over 2.5 billion at risk for dengue alone.","[{'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Collins', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, The Hope Clinic of the Emory Vaccine Center, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Gail E', 'Initials': 'GE', 'LastName': 'Potter', 'Affiliation': 'Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Matt D T', 'Initials': 'MDT', 'LastName': 'Hitchings', 'Affiliation': 'Emerging Pathogens Institute and Department of Biology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, The Hope Clinic of the Emory Vaccine Center, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Wiles', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, The Hope Clinic of the Emory Vaccine Center, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Jessie K', 'Initials': 'JK', 'LastName': 'Kennedy', 'Affiliation': 'The Emmes Company, LLC, Rockville, USA.'}, {'ForeName': 'Sofia B', 'Initials': 'SB', 'LastName': 'Pinto', 'Affiliation': 'World Mosquito Program, Monash University, Melbourne, 3800, Australia.'}, {'ForeName': 'Adla B M', 'Initials': 'ABM', 'LastName': 'Teixeira', 'Affiliation': 'School of Education, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Arnau', 'Initials': 'A', 'LastName': 'Casanovas-Massana', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Nadine G', 'Initials': 'NG', 'LastName': 'Rouphael', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, The Hope Clinic of the Emory Vaccine Center, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Deye', 'Affiliation': 'Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Cameron P', 'Initials': 'CP', 'LastName': 'Simmons', 'Affiliation': 'World Mosquito Program, Monash University, Melbourne, 3800, Australia.'}, {'ForeName': 'Luciano A', 'Initials': 'LA', 'LastName': 'Moreira', 'Affiliation': 'Instituto René Rachou, Fiocruz, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Mauricio L', 'Initials': 'ML', 'LastName': 'Nogueira', 'Affiliation': 'Medical School of São Jose do Rio Preto FAMERP, São Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Derek A T', 'Initials': 'DAT', 'LastName': 'Cummings', 'Affiliation': 'Emerging Pathogens Institute and Department of Biology, University of Florida, Gainesville, FL, USA. datc@ufl.edu.'}, {'ForeName': 'Albert I', 'Initials': 'AI', 'LastName': 'Ko', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, USA. albert.ko@yale.edu.'}, {'ForeName': 'Mauro M', 'Initials': 'MM', 'LastName': 'Teixeira', 'Affiliation': 'Department of Biochemistry and Immunology, Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil. mmtex.ufmg@gmail.com.'}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, The Hope Clinic of the Emory Vaccine Center, Emory University, Atlanta, GA, USA. sedupug@emory.edu.'}]",Trials,['10.1186/s13063-022-05997-4']
2994,35236391,"PAciFy Cough-a multicentre, double-blind, placebo-controlled, crossover trial of morphine sulphate for the treatment of pulmonary Fibrosis Cough.","BACKGROUND


Idiopathic pulmonary fibrosis (IPF) is a progressive disease that leads to lung scarring. Cough is reported by 85% of patients with IPF and can be a distressing symptom with a significant impact on patients' quality of life. There are no proven effective therapies for IPF-related cough. Whilst morphine is frequently used as a palliative agent for breathlessness in IPF, its effects on cough have never been tested. PAciFy Cough is a multicenter, double-blind, placebo-controlled, crossover trial of morphine sulphate for the treatment of cough in IPF.
METHODS


We will recruit 44 subjects with IPF prospectively from three interstitial lung disease units in the UK, namely the Royal Brompton Hospital, Manchester University NHS Foundation Trust (MFT) and Aintree University Hospital NHS Foundation Trust. Patients will be randomised (1:1) to either placebo twice daily or morphine sulphate 5 mg twice daily for 14 days. They will then crossover after a 7-day washout period. The primary endpoint is the percent change in daytime cough frequency (coughs per hour) from baseline as assessed by objective cough monitoring at day 14 of treatment.
DISCUSSION


This multicentre, randomised trial will assess the effect of opioids on cough counts and cough associated quality of life in IPF subjects. If proven to be an effective intervention, it represents a readily available treatment for patients.
TRIAL REGISTRATION


The study was approved by the UK Medicines and Healthcare Regulatory Agency (Ref: CTA 21268/0224/001-0001 - EUDRACT 2019-003571-19 - Protocol Number RBH2019/001) on 08 April 2020, in compliance with the European Clinical Trials Directive and the Medicines for Human Use (Clinical Trials) Regulations 2004 and its subsequent amendments. The study was provided with ethical approval by the London Brent Research Ethics Committee (Ref: 20/LO/0368) on 21 May 2020 and is registered with clinicaltrials.gov (NCT04429516) on 12 June 2020, available at https://clinicaltrials.gov/ct2/show/NCT04429516.",2022,"This multicentre, randomised trial will assess the effect of opioids on cough counts and cough associated quality of life in IPF subjects.","['Idiopathic pulmonary fibrosis (IPF', '44 subjects with IPF prospectively from three interstitial lung disease units in the UK, namely the Royal Brompton Hospital, Manchester University NHS Foundation Trust (MFT) and Aintree University Hospital NHS Foundation Trust', 'IPF subjects', 'cough in IPF', '08 April 2020, in compliance with the European Clinical Trials Directive and the Medicines for Human Use (Clinical Trials) Regulations 2004 and its subsequent amendments', 'pulmonary Fibrosis Cough']","['morphine', 'opioids', 'placebo twice daily or morphine sulphate', 'placebo', 'morphine sulphate']","['cough counts and cough associated quality of life', 'Cough', 'percent change in daytime cough frequency']","[{'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0066814', 'cui_str': 'Morphine sulfate'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",44.0,0.436457,"This multicentre, randomised trial will assess the effect of opioids on cough counts and cough associated quality of life in IPF subjects.","[{'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': ""Royal Brompton Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Banya', 'Affiliation': ""Royal Brompton Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Chaudhuri', 'Affiliation': 'Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Jakupovic', 'Affiliation': ""Royal Brompton Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'Keck School of Medicine, University of Southern California, Lon Angeles, USA.'}, {'ForeName': 'Brijesh', 'Initials': 'B', 'LastName': 'Patel', 'Affiliation': ""Royal Brompton Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Spencer', 'Affiliation': 'Liverpool Interstitial Lung Disease Service, Aintree University Hospital, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Muhunthan', 'Initials': 'M', 'LastName': 'Thillai', 'Affiliation': 'Royal Papworth Hospital; Department of Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'West', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Westoby', 'Affiliation': ""Royal Brompton Hospital, Guy's and St Thomas' NHS Foundation Trust; National Heart and Lung Institute, Imperial College London, London, UK.""}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Wijsenbeek', 'Affiliation': 'Centre for Interstitial Lung Disease and Sarcoidosis, Erasmus University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Philip L', 'Initials': 'PL', 'LastName': 'Molyneaux', 'Affiliation': ""Royal Brompton Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK. p.molyneaux@imperial.ac.uk.""}]",Trials,['10.1186/s13063-022-06068-4']
2995,35236375,A pilot randomized placebo-controlled study on modified MaZiRenWan: a formulated Chinese medicine to relieve constipation for palliative cancer patients.,"BACKGROUND


Constipation is a common problem among advanced cancer patients; however, many of them find limited effective from current therapies. Thus, we aimed to test the effect of a traditional Chinese herbal formula, modified MaZiRenWan (MZRW), by comparing with placebo among palliative cancer patients with constipation.
METHODS


This is a randomized, double-blind, placebo-controlled trial. Participants aged over 18 were recruited and randomized to MZRW or placebo group in addition to current prescriptions (including ongoing laxatives treatment) for two weeks. Exclusion criteria included cognitive impairment, presence of a colostomy or gastrointestinal obstruction and estimated life expectancy of less than one month. Individualized modification of MZRW was allowed according to the traditional Chinese medicine (TCM) pattern of patient. The primary outcome was the global assessment of improvement, which reflected whether the constipation had improved, remained the same or worsened.
RESULTS


Sixty patients, with mean age 75.2 years (range 47-95 years), were randomized to MZRW or placebo group. Among the MZRW group, 59.3% (16/27) had improvement in the global assessment score, as compared with 28.6% (8/28) of the placebo group (p-value = 0.022). Besides, the MZRW group had significant increase in stool frequency, and reduction in constipation severity and straining of defecation (p-value < 0.05). No serious adverse event was reported due to the research medication.
CONCLUSION


This pilot trial suggests modified MZRW is well-tolerated and effective for relief of constipation in patients with advance cancer. It could be considered as a potential treatment option for constipation in palliative care.
TRIAL REGISTRATION


The trial had been registered in ClinicalTrials.gov with identifier number NCT02795390 [ https://clinicaltrials.gov/ct2/show/NCT02795390 ] on June 10, 2016.",2022,"Among the MZRW group, 59.3% (16/27) had improvement in the global assessment score, as compared with 28.6% (8/28) of the placebo group (p-value = 0.022).","['Exclusion criteria included cognitive impairment, presence of a colostomy or gastrointestinal obstruction and estimated life expectancy of less than one month', 'patients with advance cancer', 'Participants aged over 18', 'palliative cancer patients', 'Sixty patients, with mean age 75.2\xa0years (range 47-95\xa0years', 'advanced cancer patients', 'palliative cancer patients with constipation']","['placebo', 'traditional Chinese herbal formula, modified MaZiRenWan (MZRW', 'MZRW', 'MZRW or placebo', 'modified MaZiRenWan']","['global assessment of improvement', 'stool frequency', 'constipation severity and straining of defecation', 'global assessment score']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}, {'cui': 'C0236124', 'cui_str': 'Gastrointestinal obstruction'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3884847', 'cui_str': 'ma zi ren wan'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",,0.699659,"Among the MZRW group, 59.3% (16/27) had improvement in the global assessment score, as compared with 28.6% (8/28) of the placebo group (p-value = 0.022).","[{'ForeName': 'Chung-Wah', 'Initials': 'CW', 'LastName': 'Cheng', 'Affiliation': ""Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, 3/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong, SAR, People's Republic of China.""}, {'ForeName': 'Hoi-Fung', 'Initials': 'HF', 'LastName': 'Mok', 'Affiliation': ""Yan Chai Hospital - Hong Kong Baptist University Clinical Centre for Training and Research in Chinese Medicine (West Kowloon), Yan Chai Hospital, Hong Kong, SAR, People's Republic of China.""}, {'ForeName': 'Cora W S', 'Initials': 'CWS', 'LastName': 'Yau', 'Affiliation': ""Integrated Palliative Care Unit, Department of Medicine, Hong Kong Buddhist Hospital, Hong Kong, SAR, People's Republic of China.""}, {'ForeName': 'Jasmine T M', 'Initials': 'JTM', 'LastName': 'Chan', 'Affiliation': ""Palliative Care Unit, Department of Medicine and Geriatrics, Our Lady of Maryknoll Hospital, Hong Kong, SAR, People's Republic of China.""}, {'ForeName': 'Yu-Chen', 'Initials': 'YC', 'LastName': 'Kang', 'Affiliation': ""Hong Kong Buddhist Association-University of Hong Kong Clinical Centre for Teaching and Research in Chinese Medicine, Hong Kong, SAR, People's Republic of China.""}, {'ForeName': 'Pui-Yan', 'Initials': 'PY', 'LastName': 'Lam', 'Affiliation': ""Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, 3/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong, SAR, People's Republic of China.""}, {'ForeName': 'Linda L D', 'Initials': 'LLD', 'LastName': 'Zhong', 'Affiliation': ""Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, 3/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong, SAR, People's Republic of China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': ""Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, 3/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong, SAR, People's Republic of China.""}, {'ForeName': 'Bacon F L', 'Initials': 'BFL', 'LastName': 'Ng', 'Affiliation': ""Chinese Medicine Department, Hospital Authority, Hong Kong, SAR, People's Republic of China.""}, {'ForeName': 'Annie O L', 'Initials': 'AOL', 'LastName': 'Kwok', 'Affiliation': ""Palliative Care Unit, Department of Medicine and Geriatrics, Caritas Medical Centre, 111 Wing Hong Street, Shamshuipo, Hong Kong, SAR, People's Republic of China. kwokol@ha.org.hk.""}, {'ForeName': 'Doris M W', 'Initials': 'DMW', 'LastName': 'Tse', 'Affiliation': ""Palliative Care Unit, Department of Medicine and Geriatrics, Caritas Medical Centre, 111 Wing Hong Street, Shamshuipo, Hong Kong, SAR, People's Republic of China. mwtse@ha.org.hk.""}, {'ForeName': 'Zhao-Xiang', 'Initials': 'ZX', 'LastName': 'Bian', 'Affiliation': ""Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, 3/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong, SAR, People's Republic of China. bzxiang@hkbu.edu.hk.""}]",Chinese medicine,['10.1186/s13020-022-00580-0']
2996,34882831,"Efficacy and tolerability of once-weekly selinexor, bortezomib, and dexamethasone in comparison with standard twice-weekly bortezomib and dexamethasone in previously treated multiple myeloma with renal impairment: Subgroup analysis from the BOSTON study.",,2022,,['previously treated multiple myeloma with renal impairment'],"['selinexor, bortezomib, and dexamethasone', 'bortezomib and dexamethasone']",['Efficacy and tolerability'],"[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]","[{'cui': 'C3852671', 'cui_str': 'Selinexor'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0360313,,"[{'ForeName': 'Sosana', 'Initials': 'S', 'LastName': 'Delimpasi', 'Affiliation': 'General Hospital Evangelismos, Athens, Greece.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Hospital Universitario de Salamanca, Salamanca, Spain.'}, {'ForeName': 'Holger W', 'Initials': 'HW', 'LastName': 'Auner', 'Affiliation': 'The Hugh and Josseline Langmuir Centre for Myeloma Research, Imperial College London, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gavriatopoulou', 'Affiliation': 'Alexandra Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""St. Vincent's Hospital, University of Melbourne, Fitzroy, Victoria, Australia.""}, {'ForeName': 'Halyna', 'Initials': 'H', 'LastName': 'Pylypenko', 'Affiliation': 'Department of Hematology, Cherkassy Regional Oncological Center, Cherkassy, Ukraine.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hájek', 'Affiliation': 'Department of Hemato-oncology, University Hospital Ostrava, University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Leleu', 'Affiliation': 'Department of Hematology, CHU la Miletrie and Inserm CIC 1402, Poitiers, France.'}, {'ForeName': 'Tuphan Kanti', 'Initials': 'TK', 'LastName': 'Dolai', 'Affiliation': 'Nil Ratan Sircar Medical College and Hospital, Kolkata, India.'}, {'ForeName': 'Dinesh Kumar', 'Initials': 'DK', 'LastName': 'Sinha', 'Affiliation': 'State Cancer Institute, Indira Gandhi Institute of Medical Sciences, Patna, India.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Venner', 'Affiliation': 'Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Benjamin', 'Affiliation': 'Kings College Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Mamta Krishnan', 'Initials': 'MK', 'LastName': 'Garg', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Doronin', 'Affiliation': 'City Clinical Hospital #40, Moscow, Russian Federation.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Levy', 'Affiliation': 'Baylor University Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University of Nantes, Nantes, France.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Karyopharm Therapeutics, Newton, Massachusetts, USA.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Arazy', 'Affiliation': 'Karyopharm Therapeutics, Newton, Massachusetts, USA.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Shah', 'Affiliation': 'Karyopharm Therapeutics, Newton, Massachusetts, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Shacham', 'Affiliation': 'Karyopharm Therapeutics, Newton, Massachusetts, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Kauffman', 'Affiliation': 'Karyopharm Therapeutics, Newton, Massachusetts, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Medical University of Silesia, Katowice, Poland.'}]",American journal of hematology,['10.1002/ajh.26434']
2997,34812127,Serum metabolite profiling yields insights into health promoting effect of A. muciniphila in human volunteers with a metabolic syndrome.,"Reduction of  A. muciniphila  relative abundance in the gut microbiota is a widely accepted signature associated with obesity-related metabolic disorders. Using untargeted metabolomics profiling of fasting plasma, our study aimed at identifying metabolic signatures associated with beneficial properties of alive and pasteurized  A. muciniphila  when administrated to a cohort of insulin-resistant individuals with metabolic syndrome. Our data highlighted either shared or specific alterations in the metabolome according to the form of  A. muciniphila  administered with respect to a control group. Common responses encompassed modulation of amino acid metabolism, characterized by reduced levels of arginine and alanine, alongside several intermediates of tyrosine, phenylalanine, tryptophan, and glutathione metabolism. The global increase in levels of acylcarnitines together with specific modulation of acetoacetate also suggested induction of ketogenesis through enhanced β-oxidation. Moreover, our data pinpointed some metabolites of interest considering their emergence as substantial compounds pertaining to health and diseases in the more recent literature.",2021,"Common responses encompassed modulation of amino acid metabolism, characterized by reduced levels of arginine and alanine, alongside several intermediates of tyrosine, phenylalanine, tryptophan, and glutathione metabolism.","['cohort of insulin-resistant individuals with metabolic syndrome', 'human volunteers with a metabolic syndrome']",[],[],"[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]",[],[],,0.047841,"Common responses encompassed modulation of amino acid metabolism, characterized by reduced levels of arginine and alanine, alongside several intermediates of tyrosine, phenylalanine, tryptophan, and glutathione metabolism.","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Depommier', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Walloon Excellence in Life Sciences and BIOtechnology (Welbio), UCLouvain, Université Catholique De Louvain, Brussels, Belgium.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Everard', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Walloon Excellence in Life Sciences and BIOtechnology (Welbio), UCLouvain, Université Catholique De Louvain, Brussels, Belgium.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Druart', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Walloon Excellence in Life Sciences and BIOtechnology (Welbio), UCLouvain, Université Catholique De Louvain, Brussels, Belgium.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Maiter', 'Affiliation': 'Pôle Edin, Institut De Recherches Expérimentales Et Cliniques, UCLouvain, Université Catholique De Louvain, Brussels, Belgium.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Thissen', 'Affiliation': 'Pôle Edin, Institut De Recherches Expérimentales Et Cliniques, UCLouvain, Université Catholique De Louvain, Brussels, Belgium.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Loumaye', 'Affiliation': 'Pôle Edin, Institut De Recherches Expérimentales Et Cliniques, UCLouvain, Université Catholique De Louvain, Brussels, Belgium.'}, {'ForeName': 'Michel P', 'Initials': 'MP', 'LastName': 'Hermans', 'Affiliation': 'Pôle Edin, Institut De Recherches Expérimentales Et Cliniques, UCLouvain, Université Catholique De Louvain, Brussels, Belgium.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Delzenne', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Walloon Excellence in Life Sciences and BIOtechnology (Welbio), UCLouvain, Université Catholique De Louvain, Brussels, Belgium.'}, {'ForeName': 'Willem M', 'Initials': 'WM', 'LastName': 'de Vos', 'Affiliation': 'Laboratory of Microbiology, Wageningen University, Wageningen, The Netherland.'}, {'ForeName': 'Patrice D', 'Initials': 'PD', 'LastName': 'Cani', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Walloon Excellence in Life Sciences and BIOtechnology (Welbio), UCLouvain, Université Catholique De Louvain, Brussels, Belgium.'}]",Gut microbes,['10.1080/19490976.2021.1994270']
2998,34878650,"Response to: 'Anakinra for palmoplantar pustulosis: results from a randomized, double-blind, multicentre, two-staged, adaptive placebo-controlled trial (APRICOT)': reply from the authors.","We believe that there is significant interest in the role of IL-1 in the pathomechanism of palmoplantar pustulosis. However, the APRICOT study failed to demonstrate a therapeutic effect of the IL-1 receptor antagonist. So, we recommend that the authors perform an additional subgroup analysis based on the presence or absence of plaque psoriasis.",2021,"However, the APRICOT study failed to demonstrate a therapeutic effect of the IL-1 receptor antagonist.",['palmoplantar pustulosis'],['placebo'],[],"[{'cui': 'C0030246', 'cui_str': 'Pustular psoriasis of palms and soles'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.523588,"However, the APRICOT study failed to demonstrate a therapeutic effect of the IL-1 receptor antagonist.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cro', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, W12 7RH, UK.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Smith', 'Affiliation': ""St John's Institute of Dermatology, Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust, London, SE1 9RT, UK.""}]",The British journal of dermatology,['10.1111/bjd.20944']
2999,34875694,"Alcohol Misuse among English Youth, Are Harms Attributable to Alcohol or to Underlying Disinhibitory Characteristics?","INTRODUCTION


Alcohol use by young people is associated with a range of psychological and physical harms. However, similar harms are also reported with disinhibitory conditions such as conduct problems that are said to precede and predispose to alcohol misuse. We explored whether alcohol use or indicators of underlying disinhibition predict psychological and physical harms in a cohort of young people.
METHODS


We used data from a randomised controlled intervention trial that identified young people who consumed alcohol (n = 756), mean age = 15.6 years, attending emergency departments (EDs) in England. Disinhibition was measured by the self-report Strengths and Difficulties Questionnaire hyperactivity and conduct problem items, and alcohol-related harms by questions from the ESPAD, a major European school survey. We conducted a mediation analysis with a primary outcome of frequency of engaging in alcohol-related harms 12 months after screening in ED, exploring for the mediating influence of alcohol consumed at six months. We included age, gender, allocated group and baseline consumption as covariates and adjusted for the multi-level nature of the study, where young people were nested within EDs.
RESULTS


Conduct problems and to a lesser extent hyperactivity predicted harms at twelve months. This effect was not mediated by alcohol consumed at 6 months.
CONCLUSIONS


Among young drinkers underlying behavioural attributes predict harm independently of alcohol use. This suggests that the harms associated with alcohol use are attributable more to underlying disinhibitory characteristics than the quantity of alcohol consumed.",2021,"This effect was not mediated by alcohol consumed at 6 months.
","['young drinkers', 'English Youth', 'young people who consumed alcohol (n = 756), mean age = 15.6 years, attending emergency departments (EDs) in England']",[],['Disinhibition'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0014282', 'cui_str': 'England'}]",[],"[{'cui': 'C0234410', 'cui_str': 'Disinhibition'}]",756.0,0.0230251,"This effect was not mediated by alcohol consumed at 6 months.
","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McArdle', 'Affiliation': 'Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, St. Nicholas Hospital, Jubilee Road, NE3 3XT, Newcastle upon Tyne, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Coulton', 'Affiliation': 'Centre for Health Services Studies, University of Kent, Canterbury, Kent CT2 7NF, UK.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Institute of Health and Society, Newcastle University, Baddiley-Clark Building, NE2 4AX, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Eilish', 'Initials': 'E', 'LastName': 'Gilvarry', 'Affiliation': 'Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, St. Nicholas Hospital, Jubilee Road, NE3 3XT, Newcastle upon Tyne, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Drummond', 'Affiliation': ""Addictions Department, National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 de Crespigny Park, London SE5 8AF, UK.""}]","Alcohol and alcoholism (Oxford, Oxfordshire)",['10.1093/alcalc/agab077']
3000,34863332,"Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial.","BACKGROUND


The pathophysiology of COVID-19 includes immune-mediated hyperinflammation, which could potentially lead to respiratory failure and death. Granulocyte-macrophage colony-stimulating factor (GM-CSF) is among cytokines that contribute to the inflammatory processes. Lenzilumab, a GM-CSF neutralising monoclonal antibody, was investigated in the LIVE-AIR trial to assess its efficacy and safety in treating COVID-19 beyond available treatments.
METHODS


In LIVE-AIR, a phase 3, randomised, double-blind, placebo-controlled trial, hospitalised adult patients with COVID-19 pneumonia not requiring invasive mechanical ventilation were recruited from 29 sites in the USA and Brazil and were randomly assigned (1:1) to receive three intravenous doses of lenzilumab (600 mg per dose) or placebo delivered 8 h apart. All patients received standard supportive care, including the use of remdesivir and corticosteroids. Patients were stratified at randomisation by age and disease severity. The primary endpoint was survival without invasive mechanical ventilation to day 28 in the modified intention-to-treat population (mITT), comprising all randomised participants who received at least one dose of study drug under the documented supervision of the principal investigator or sub-investigator. Adverse events were assessed in all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT04351152, and is completed.
FINDINGS


Patients were enrolled from May 5, 2020, until Jan 27, 2021. 528 patients were screened, of whom 520 were randomly assigned and included in the intention-to-treat population. 479 of these patients (n=236, lenzilumab; n=243, placebo) were included in the mITT analysis for the primary outcome. Baseline demographics were similar between groups. 311 (65%) participants were males, mean age was 61 (SD 14) years at baseline, and median C-reactive protein concentration was 79 (IQR 41-137) mg/L. Steroids were administered to 449 (94%) patients and remdesivir to 347 (72%) patients; 331 (69%) patients received both treatments. Survival without invasive mechanical ventilation to day 28 was achieved in 198 (84%; 95% CI 79-89) participants in the lenzilumab group and in 190 (78%; 72-83) patients in the placebo group, and the likelihood of survival was greater with lenzilumab than placebo (hazard ratio 1·54; 95% CI 1·02-2·32; p=0·040). 68 (27%) of 255 patients in the lenzilumab group and 84 (33%) of 257 patients in the placebo group experienced at least one adverse event that was at least grade 3 in severity based on CTCAE criteria. The most common treatment-emergent adverse events of grade 3 or higher were related to respiratory disorders (26%) and cardiac disorders (6%) and none led to death.
INTERPRETATION


Lenzilumab significantly improved survival without invasive mechanical ventilation in hospitalised patients with COVID-19, with a safety profile similar to that of placebo. The added value of lenzilumab beyond other immunomodulators used to treat COVID-19 alongside steroids remains unknown.
FUNDING


Humanigen.",2022,"Survival without invasive mechanical ventilation to day 28 was achieved in 198 (84%; 95% CI 79-89) participants in the lenzilumab group and in 190 (78%; 72-83) patients in the placebo group, and the likelihood of survival was greater with lenzilumab than placebo (hazard ratio 1·54; 95% CI 1·02-2·32; p=0·040).","['528 patients were screened, of whom 520 were randomly assigned and included in the intention-to-treat population', 'Patients were enrolled from May 5, 2020, until Jan 27, 2021', '311 (65%) participants were males, mean age was 61 (SD 14) years at baseline, and median C-reactive protein concentration was 79 (IQR 41-137) mg/L. Steroids were administered to 449 (94%) patients and remdesivir to 347 (72%) patients; 331 (69%) patients received both treatments', 'hospitalised patients', 'hospitalised adult patients with COVID-19 pneumonia not requiring invasive mechanical ventilation were recruited from 29 sites in the USA and Brazil', 'hospitalised patients with COVID-19 pneumonia (LIVE-AIR']","['standard supportive care', 'Lenzilumab', 'Granulocyte-macrophage colony-stimulating factor (GM-CSF', 'placebo', 'lenzilumab']","['survival without invasive mechanical ventilation', 'cardiac disorders', 'Adverse events', 'efficacy and safety', 'likelihood of survival', 'Survival without invasive mechanical ventilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",528.0,0.85833,"Survival without invasive mechanical ventilation to day 28 was achieved in 198 (84%; 95% CI 79-89) participants in the lenzilumab group and in 190 (78%; 72-83) patients in the placebo group, and the likelihood of survival was greater with lenzilumab than placebo (hazard ratio 1·54; 95% CI 1·02-2·32; p=0·040).","[{'ForeName': 'Zelalem', 'Initials': 'Z', 'LastName': 'Temesgen', 'Affiliation': 'Division of Infectious Diseases, Mayo Clinic, Rochester, MN, USA. Electronic address: temesgen.zelalem@mayo.edu.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Burger', 'Affiliation': 'Mayo Clinic, Division of Pulmonary, Allergy and Sleep Medicine, Jacksonville, FL, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Hennepin Healthcare Research Institute, Minneapolis, MN, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Polk', 'Affiliation': 'Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Libertin', 'Affiliation': 'Mayo Clinic, Division of Infectious Diseases, Jacksonville, FL, USA.'}, {'ForeName': 'Colleen F', 'Initials': 'CF', 'LastName': 'Kelley', 'Affiliation': 'Division of Infectious Diseases, Emory University School of Medicine, Atlanta, GA, USA; Grady Memorial Hospital, Atlanta, GA, USA.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Division of Infectious Diseases, Emory University School of Medicine, Atlanta, GA, USA; Rollins School of Public Health and Emory Vaccine Center, Atlanta, GA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Orenstein', 'Affiliation': 'Mayo Clinic Arizona, Division of Infectious Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Catterson', 'Affiliation': 'BioSymetrics, New York, NY, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Aronstein', 'Affiliation': 'CTI, Clinical Trial Services, Covington, KY, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Durrant', 'Affiliation': 'Humanigen, Burlingame, CA, USA.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Chappell', 'Affiliation': 'Humanigen, Burlingame, CA, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Ahmed', 'Affiliation': 'Humanigen, Burlingame, CA, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Chappell', 'Affiliation': 'Humanigen, Burlingame, CA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Badley', 'Affiliation': 'Division of Infectious Diseases, Mayo Clinic, Rochester, MN, USA; Department of Molecular Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(21)00494-X']
3001,35230884,"Weekly Cisplatin Plus Radiation for Postoperative Head and Neck Cancer (JCOG1008): A Multicenter, Noninferiority, Phase II/III Randomized Controlled Trial.","PURPOSE


The standard treatment for postoperative high-risk locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) is chemoradiotherapy with 3-weekly cisplatin (100 mg/m 2 ). However, whether chemoradiotherapy with weekly cisplatin (40 mg/m 2 ) yields comparable efficacy with 3-weekly cisplatin in postoperative high-risk LA-SCCHN is unknown.
PATIENTS AND METHODS


In this multi-institutional open-label phase II/III trial, patients with postoperative high-risk LA-SCCHN were randomly assigned to receive either chemoradiotherapy with 3-weekly cisplatin (100 mg/m 2 ) or with weekly cisplatin (40 mg/m 2 ) to confirm the noninferiority of weekly cisplatin. The primary end point of phase II was the proportion of treatment completion, and that of phase III was overall survival. A noninferiority margin of hazard ratio was set at 1.32.
RESULTS


Between October 2012 and December 2018, a total of 261 patients were enrolled (3-weekly cisplatin, 132 patients; weekly cisplatin, 129 patients). At the planned third interim analysis in the phase III part, after a median follow-up of 2.2 (interquartile range 1.19-3.56) years, chemoradiotherapy with weekly cisplatin was noninferior to 3-weekly cisplatin in terms of overall survival, with a hazard ratio of 0.69 (99.1% CI, 0.374 to 1.273 [< 1.32], one-sided  P  for noninferiority = .0027 < .0043). Grade 3 or more neutropenia and infection were less frequent in the weekly arm (3-weekly  v  weekly, 49%  v  35% and 12%  v  7%, respectively), as were renal impairment and hearing impairment. No treatment-related death was reported in the 3-weekly arm, and two (1.6%) in the weekly arm.
CONCLUSION


Chemoradiotherapy with weekly cisplatin is noninferior to 3-weekly cisplatin for patients with postoperative high-risk LA-SCCHN. These findings suggest that chemoradiotherapy with weekly cisplatin can be a possible treatment option for these patients.",2022,"Grade 3 or more neutropenia and infection were less frequent in the weekly arm (3-weekly  v  weekly, 49%  v  35% and 12%  v  7%, respectively), as were renal impairment and hearing impairment.","['postoperative high-risk locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN', 'patients with postoperative high-risk LA-SCCHN', 'Between October 2012 and December 2018, a total of 261 patients were enrolled (3-weekly cisplatin, 132 patients; weekly cisplatin, 129 patients', 'Postoperative Head and Neck Cancer (JCOG1008']","['chemoradiotherapy with 3-weekly cisplatin', 'chemoradiotherapy with weekly cisplatin', 'Chemoradiotherapy with weekly cisplatin', 'Weekly Cisplatin Plus Radiation', 'cisplatin']","['Grade 3 or more neutropenia and infection', 'proportion of treatment completion, and that of phase III was overall survival', 'renal impairment and hearing impairment', 'death', 'overall survival']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",261.0,0.0533021,"Grade 3 or more neutropenia and infection were less frequent in the weekly arm (3-weekly  v  weekly, 49%  v  35% and 12%  v  7%, respectively), as were renal impairment and hearing impairment.","[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kiyota', 'Affiliation': 'Kobe University Hospital, Cancer Center, Kobe, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kodaira', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Jichi Medical University Hospital, Shimotsuke, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Yamazaki', 'Affiliation': 'Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Mitani', 'Affiliation': 'Cancer Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Shigemichi', 'Initials': 'S', 'LastName': 'Iwae', 'Affiliation': 'Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Fujimoto', 'Affiliation': 'Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Onozawa', 'Affiliation': 'Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Hanai', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Takenori', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Saitama Cancer Center, Ina, Japan.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Monden', 'Affiliation': 'Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Shimura', 'Affiliation': 'Jikei University Hospital, Tokyo, Japan.'}, {'ForeName': 'Shujiro', 'Initials': 'S', 'LastName': 'Minami', 'Affiliation': 'National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Kindai University Hospital, Osakasayama, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Homma', 'Affiliation': 'Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Seiichi', 'Initials': 'S', 'LastName': 'Yoshimoto', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Oridate', 'Affiliation': 'Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Omori', 'Affiliation': 'Kyoto University Hospital Kyoto, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Okami', 'Affiliation': 'Tokai University School of Medicine, Isehara, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Ota', 'Affiliation': 'Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Kiyoto', 'Initials': 'K', 'LastName': 'Shiga', 'Affiliation': 'Iwate Medical University, Shiwa, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Sugasawa', 'Affiliation': 'Saitama Medical University International Medical Center, Hidaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Asakage', 'Affiliation': 'Tokyo Medical and Dental University Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Murono', 'Affiliation': 'Fukushima Medical University Hospital, Fukushima, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'Kindai University Hospital, Osakasayama, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Ryuichi', 'Initials': 'R', 'LastName': 'Hayashi', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.01293']
3002,35231192,Letter to the Editor:  From Target Temperature Management Trial 1 to Trial 2: Therapeutic Hypothermia for Cardiac Arrest Discredited?,,2022,,[],[],[],[],[],[],,0.0806979,,"[{'ForeName': 'Qiangrong', 'Initials': 'Q', 'LastName': 'Zhai', 'Affiliation': 'Department of Emergency, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Department of Emergency, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, Australia.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'The Clinical Epidemiology Research Center, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Emergency Medicine, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Qingbian', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'Department of Emergency, Peking University Third Hospital, Beijing, China.'}]",Therapeutic hypothermia and temperature management,['10.1089/ther.2022.0003']
3003,35231185,"""Practice Makes Perfect""? Associations Between Home Practice and Physical and Emotional Function Outcomes Among Patients with Chronic Pain Enrolled in a Mind-Body Program.","Objectives:  To summarize the characteristics of home practice adherence in patients with chronic pain randomized to a 10-week group mind-body activity program with ( GetActive-Fitbit ) and without ( GetActive ) a digital monitoring device, and test the association between home practice adherence and improvement in physical and emotional treatment outcomes.  Methods:  Data were collected in a pilot randomized controlled trial (RCT) of the  GetActive  ( n  = 41) and  GetActive-Fitbit  ( n  = 41) programs. Participants submitted weekly home practice logs depicting their daily physical activity and practice of relaxation and gratitude skills. Participants completed assessments of physical (patient-reported, performance-based, and accelerometer-measured) and emotional function outcomes both before and after the programs. Participants in both programs were combined due to the identical session and home practice content.  Results:  Participants reported engaging in physical activity on average 30.62 days (SD = 20.28, 48.6% of intervention days), relaxation skill practice on average 29.87 days (SD = 21.16, 47.4% of intervention days), and gratitude practice on average 32.10 days (SD = 22.12, 51.0% of intervention days). The average duration of physical activity and relaxation skill practice were 44.40 min a day (SD = 59.44) and 11.15 min a day (SD = 12.00), respectively. The duration of physical activity was significantly associated with decrease depression symptoms ( p  = 0.049, η 2  = 0.056). No other association was found between home practice and change in outcomes.  Conclusions:  Patients with chronic pain are generally able and willing to engage in home practice during a mind-body activity intervention. Emphasizing longer duration of physical activity practice may contribute to an improvement in depression. Future fully powered RCTs with rigorous assessment of home practice adherence and dose-response designs may further elucidate the role of home practice in improvements in treatment outcomes.  ClinicalTrials.gov identifier:  NCT03412916.",2022,"The duration of physical activity was significantly associated with decrease depression symptoms ( p  = 0.049, η 2  = 0.056).","['Patients with chronic pain', 'patients with chronic pain', 'Patients with Chronic Pain']","['GetActive  ( n \u2009=\u200941) and  GetActive-Fitbit  ( n \u2009=\u200941) programs', '10-week group mind-body activity program with ( GetActive-Fitbit ) and without ( GetActive ) a digital monitoring device']","['relaxation skill practice', 'depression symptoms', 'Physical and Emotional Function Outcomes', 'average duration of physical activity and relaxation skill practice', 'duration of physical activity', 'engaging in physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.0436733,"The duration of physical activity was significantly associated with decrease depression symptoms ( p  = 0.049, η 2  = 0.056).","[{'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Hopkins', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Greenberg', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Isaacs', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}]",Journal of integrative and complementary medicine,['10.1089/jicm.2021.0324']
3004,35231149,A Polylysine dendrigraft is able to differentially impact Cutibacterium acnes strains preventing acneic skin.,"With a view to reducing the impact of Cutibacterium acnes on acne vulgaris, it now appears interesting to modify the balance between acneic and non-acneic strains of C. acnes using moderate approach. In the present study, we identified that a G2 dendrigraft of lysine dendrimer (G2 dendrimer) was able to modify membrane fluidity and biofilm formation of a C. acnes acneic strain (RT5), whereas it appeared no or less active on a C. acnes non-acneic strain (RT6). Moreover, skin ex vivo data indicated that the G2 is able to decrease inflammation (IL1α and TLR2) and improve skin desquamation after of C. acnes acneic strains colonization. Then, in vivo data confirmed, after C. acnes quantification by metagenomic analysis, that the G2 cream after 28 days of treatment was able to increase the diversity of C. acnes strains versus placebo cream. Data showed also a modification of the balance expression between C. acnes phylotype IA1 and phylotype II abundances. Taken together, the results confirm the interest of using soft compounds in cosmetic product for modifying phylotype abundances as well as diversity of C. acnes strains could be a new strategy for prevent acne vulgaris outbreak.",2022,"Moreover, skin ex vivo data indicated that the G2 is able to decrease inflammation (IL1α and TLR2) and improve skin desquamation after of C. acnes acneic strains colonization.",[],[],"['inflammation (IL1α and TLR2', 'skin desquamation']",[],[],"[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0754727', 'cui_str': 'TLR2 protein, human'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}]",,0.0221285,"Moreover, skin ex vivo data indicated that the G2 is able to decrease inflammation (IL1α and TLR2) and improve skin desquamation after of C. acnes acneic strains colonization.","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Attia', 'Affiliation': ""Lucas Meyer Cosmetics, 195 route d'Espagne, 31036, Toulouse.""}, {'ForeName': 'Magalie', 'Initials': 'M', 'LastName': 'Barreau', 'Affiliation': 'Laboratoire de Microbiologie Signaux et Microenvironnement, LMSM EA4312, Normandie Université, Université de Rouen Normandie, Evreux, France.'}, {'ForeName': 'Esther Le', 'Initials': 'EL', 'LastName': 'Toquin', 'Affiliation': 'GIP Normandie Sécurité Sanitaire (N2S), Evreux, France.'}, {'ForeName': 'Marc G J', 'Initials': 'MGJ', 'LastName': 'Feuilloley', 'Affiliation': 'Laboratoire de Microbiologie Signaux et Microenvironnement, LMSM EA4312, Normandie Université, Université de Rouen Normandie, Evreux, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Loing', 'Affiliation': ""Lucas Meyer Cosmetics, 195 route d'Espagne, 31036, Toulouse.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Lesouhaitier', 'Affiliation': 'Laboratoire de Microbiologie Signaux et Microenvironnement, LMSM EA4312, Normandie Université, Université de Rouen Normandie, Evreux, France.'}]",Experimental dermatology,['10.1111/exd.14554']
3005,35231098,Effectiveness of a multicomponent exercise program to reverse pre-frailty in community-dwelling Chinese older adults: a randomised controlled trial.,"BACKGROUND


the Xiangya Hospital circuit training (X-CircuiT), was developed to reverse pre-frailty in Chinese older adults and determine potential mechanisms through which pre-frailty is reversed.
METHODS


this randomised controlled trial was performed at Xiangya Hospital, Changsha, China from September 2020 to May 2021. Forty-eight pre-frail older adults were enrolled. Participants were randomly assigned (1:1) to X-CircuiT (46 min/session, three supervised sessions/week for 3 months at a community health centre) or control (1-time advice on physical activity without supervised exercise). The primary outcome was the proportion of participants with pre-frailty after 3-month intervention. The secondary outcomes included absolute risk reduction (ARR), number needed to treat (NNT), and the changes in senior fitness, body composition and clinical measures.
RESULTS


among 48 participants (mean age, 72 years; women [65%]), 22 participants in the X-CircuiT (92%) and 21 participants in the control (88%) completed the study. After 3 months, the proportion of pre-frailty was significantly lower in the X-CircuiT group than the control (14% versus 95%, P < 0.001). The ARR and NNT were 82% [95% CI, 65-99] and 1 [1-2], respectively. X-CircuiT was associated with significant improvements in senior fitness indicators and body composition. No significant difference in blood chemistry, carotid ultrasound and echocardiography parameters was found between groups. No significant interaction was detected between sex, BMI, baseline peak oxygen consumption and study groups.
CONCLUSION


this study demonstrates that X-CircuiT could significantly reverse pre-frailty in Chinese older adults. The underlying mechanisms may involve X-CircuiT-induced improvements in body composition and senior fitness.The trial is registered at Chictr.org.cn. Number: ChiCTR2100048125.",2022,"After 3 months, the proportion of pre-frailty was significantly lower in the X-CircuiT group than the control (14% versus 95%, P < 0.001).","['48 participants (mean age, 72\xa0years', 'Chinese older adults', 'Xiangya Hospital, Changsha, China from September 2020 to May 2021', 'Forty-eight pre-frail older adults were enrolled', ' women [65%]), 22 participants in the X-CircuiT (92%) and 21 participants in the control (88%) completed the study', 'community-dwelling Chinese older adults']","['control (1-time advice on physical activity without supervised exercise', 'multicomponent exercise program', 'Xiangya Hospital circuit training (X-CircuiT', 'X-CircuiT']","['blood chemistry, carotid ultrasound and echocardiography parameters', 'proportion of participants with pre-frailty', 'proportion of pre-frailty', 'senior fitness indicators and body composition', 'absolute risk reduction (ARR), number needed to treat (NNT), and the changes in senior fitness, body composition and clinical measures']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}]","[{'cui': 'C0005774', 'cui_str': 'Blood chemistry'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.134242,"After 3 months, the proportion of pre-frailty was significantly lower in the X-CircuiT group than the control (14% versus 95%, P < 0.001).","[{'ForeName': 'Yaoshan', 'Initials': 'Y', 'LastName': 'Dun', 'Affiliation': 'Division of Cardiac Rehabilitation, Department of Physical Medicine & Rehabilitation, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Hu', 'Affiliation': 'Division of Cardiac Rehabilitation, Department of Physical Medicine & Rehabilitation, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Ripley-Gonzalez', 'Affiliation': 'Division of Cardiac Rehabilitation, Department of Physical Medicine & Rehabilitation, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Nanjiang', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Division of Cardiac Rehabilitation, Department of Physical Medicine & Rehabilitation, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Division of Cardiac Rehabilitation, Department of Physical Medicine & Rehabilitation, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wenliang', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiac Rehabilitation, Department of Physical Medicine & Rehabilitation, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Meijuan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiac Rehabilitation, Department of Physical Medicine & Rehabilitation, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Qingsong', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Department of Retirement Systems, State Grid Hunan Electric Power Company Limited, Changsha, Hunan, China.'}, {'ForeName': 'Ni', 'Initials': 'N', 'LastName': 'Cui', 'Affiliation': 'Division of Cardiac Rehabilitation, Department of Physical Medicine & Rehabilitation, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shaoping', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Division of Cardiac Rehabilitation, Department of Physical Medicine & Rehabilitation, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Suixin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Division of Cardiac Rehabilitation, Department of Physical Medicine & Rehabilitation, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}]",Age and ageing,['10.1093/ageing/afac026']
3006,35231678,Dabigatran versus aspirin for stroke prevention after cryptogenic stroke with patent foramen ovale: A prospective study.,"BACKGROUND


Medical treatment for stroke prevention in cryptogenic stroke (CS) patients with patent foramen ovale (PFO) remains inconclusive. We compared the efficacy and safety of dabigatran with aspirin on stroke prevention for patients with recent CS and PFO.
METHODS


In this prospective cohort study, we randomly assigned patients with PFO who had a cryptogenic stroke, in a 1:1 ratio, to dabigatran or aspirin group. Patients were followed for 2 years and the primary efficacy outcome was the recurrence of stroke or systemic embolism. The primary safety outcome was occurrence of bleeding complications.
RESULTS


A total of 375 patients were enrolled in the study, 188 assigned to the dabigatran group and 187 to the aspirin group. During the 2-year follow-up, the primary efficacy outcomes occurred in 4 patients in the dabigatran group (annualized rate, 2.0%) and 11 patients in the aspirin group (annualized rate, 5.1%) (hazard ratio, 0.74; 95% confidence interval, 0.51-0.98; P = 0.049). TIA/acute ischemic stroke occurred in 3 patients in the dabigatran group and 8 patients in the aspirin group (hazard ratio, 0.72; 95% confidence interval, 0.52-0.95; P = 0.039). Bleeding complications occurred in 8 patients in the dabigatran group (annualized rate, 3.9%) and in 7 patients in the aspirin group (annualized rate, 3.5%) (hazard ratio, 1.24; 95% confidence interval, 1.01-1.52; P = 0.886).
CONCLUSION


For cryptogenic stroke with PFO, dabigatran was superior to aspirin for stroke prevention. There is no increased risk of bleeding complication with dabigatran.",2022,"Bleeding complications occurred in 8 patients in the dabigatran group (annualized rate, 3.9%) and in 7 patients in the aspirin group (annualized rate, 3.5%) (hazard ratio, 1.24; 95% confidence interval, 1.01-1.52; P = 0.886).
","['patients with recent CS and PFO', 'stroke prevention after cryptogenic stroke with patent foramen ovale', 'cryptogenic stroke (CS) patients with patent foramen ovale (PFO', 'A total of 375 patients were enrolled in the study, 188 assigned to the dabigatran group and 187 to the aspirin group', 'patients with PFO who had a cryptogenic stroke, in a 1:1 ratio, to dabigatran or aspirin group']","['Dabigatran versus aspirin', 'aspirin', 'dabigatran with aspirin']","['occurrence of bleeding complications', 'Bleeding complications', 'efficacy and safety', 'risk of bleeding complication', 'TIA/acute ischemic stroke', 'recurrence of stroke or systemic embolism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0016522', 'cui_str': 'Patent foramen ovale'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}]",375.0,0.119852,"Bleeding complications occurred in 8 patients in the dabigatran group (annualized rate, 3.9%) and in 7 patients in the aspirin group (annualized rate, 3.5%) (hazard ratio, 1.24; 95% confidence interval, 1.01-1.52; P = 0.886).
","[{'ForeName': 'Shumin', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Guangdong Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated Hospital of Chinese Medicine, Foshan, Guangdong 518000, PR China.'}, {'ForeName': 'Dongchun', 'Initials': 'D', 'LastName': 'Cai', 'Affiliation': 'Guangdong Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated Hospital of Chinese Medicine, Foshan, Guangdong 518000, PR China.'}, {'ForeName': 'Yuzheng', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Guangdong Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated Hospital of Chinese Medicine, Foshan, Guangdong 518000, PR China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Guangdong Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated Hospital of Chinese Medicine, Foshan, Guangdong 518000, PR China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Guangdong Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated Hospital of Chinese Medicine, Foshan, Guangdong 518000, PR China.'}, {'ForeName': 'Peichu', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Guangdong Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated Hospital of Chinese Medicine, Foshan, Guangdong 518000, PR China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong 510515, PR China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Guangdong Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated Hospital of Chinese Medicine, Foshan, Guangdong 518000, PR China. Electronic address: fsnhzyysunhao@163.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2022.107189']
3007,35231664,"Evaluating a food pantry-based intervention to improve food security, dietary intake and quality in Midwestern food pantries.","BACKGROUND


Voices for Food was a longitudinal community, food pantry-based intervention informed by the social ecological model, and designed to improve food security, dietary intake and quality among clients, that was carried out in 24 rural food pantries across six Midwestern states.
OBJECTIVE


The objective was to evaluate changes in adult food security, dietary intake, and quality from baseline (2014) to follow-up (2016), and to assess the role of adult food security on dietary outcomes.
DESIGN


A multistate, longitudinal, quasi-experimental intervention with matched treatment and comparison design was used to evaluate treatment versus comparison group changes over time and changes in both groups over time.
PARTICIPANTS/SETTING


Adult food pantry clients (n = 617) completed a demographic, food security survey, and up to three 24-hour dietary recalls at baseline (n = 590) and follow-up (n = 160).
INTERVENTION


Community coaching served as the experimental component that only ""treatment"" communities received while a food council guide and food pantry toolkit were provided to both ""treatment"" and matched ""comparison"" communities.
MAIN OUTCOME MEASURES


Change in adult food security status, mean usual intakes of nutrients and food groups, and Healthy Eating Index-2010 (HEI-2010) scores were the main outcome measures.
STATISTICAL ANALYSES PERFORMED


Linear mixed models estimated changes in outcomes by intervention group and by adult food security status over time.
RESULTS


Improvements in adult food security (-0.7 ± 0.3, p = 0.01), HEI-2010 total score (4.2 ± 1.1, p < 0.0001), and empty calories component scores (3.4 ± 0.5, p < 0.0001) from baseline to follow-up were observed in treatment and comparison groups but no statistically significant changes were found for adult food security status, dietary quality and usual intakes of nutrients and food groups between the two groups over time. The intervention effect on dietary quality and usual intake changes over time by adult food security status were also not observed.
CONCLUSIONS


Food pantry clients in treatment and comparison groups had higher food security and dietary quality at the follow-up evaluation of the VFF intervention trial compared to baseline despite the lack of difference among the groups as a result of the experimental coaching component.",2022,"RESULTS


Improvements in adult food security (-0.7 ± 0.3, p = 0.01), HEI-2010 total score (4.2 ± 1.1, p < 0.0001), and empty calories component scores (3.4 ± 0.5, p < 0.0001) from baseline to follow-up were observed in treatment and comparison groups but no statistically significant changes were found for adult food security status, dietary quality and usual intakes of nutrients and food groups between the two groups over time.","['Adult food pantry clients (n = 617) completed a demographic, food security survey, and up to three 24-hour dietary recalls at baseline (n = 590) and follow-up (n = 160', 'Midwestern food pantries', '24 rural food pantries across six Midwestern states']","['food pantry-based intervention', 'Community coaching served as the experimental component that only ""treatment"" communities received while a food council guide and food pantry toolkit were provided to both ""treatment"" and matched ""comparison"" communities']","['empty calories component scores', 'HEI-2010 total score', 'Change in adult food security status, mean usual intakes of nutrients and food groups, and Healthy Eating Index-2010 (HEI-2010) scores', 'food security and dietary quality', 'dietary quality and usual intake changes over time by adult food security status', 'adult food security status, dietary quality and usual intakes of nutrients']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C5191356', 'cui_str': '590'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",24.0,0.0859992,"RESULTS


Improvements in adult food security (-0.7 ± 0.3, p = 0.01), HEI-2010 total score (4.2 ± 1.1, p < 0.0001), and empty calories component scores (3.4 ± 0.5, p < 0.0001) from baseline to follow-up were observed in treatment and comparison groups but no statistically significant changes were found for adult food security status, dietary quality and usual intakes of nutrients and food groups between the two groups over time.","[{'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Eicher-Miller', 'Affiliation': 'Associate Professor, Purdue University Department of Nutrition Science, 700 W. State Street, Stone Hall G-1D, West Lafayette, IN 47907, USA, (phone) 765-494-6815, (fax) 765-494-0906. Electronic address: heicherm@purdue.edu.'}, {'ForeName': 'Breanne N', 'Initials': 'BN', 'LastName': 'Wright', 'Affiliation': 'Deputy Director, Science Department, Center for Science in the Public Interest, 1220 L St. NW, Suite 300, Washington, DC 20005, USA, (phone) 202-777-8328.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Tooze', 'Affiliation': 'Department of Biostatistics and Data Sciences, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Craig', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN 47907, USA, (phone) 765-494-6043, (fax) 765-494-0558.'}, {'ForeName': 'Yibin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Clinical Assistant Professor, Department of Community Health and Health Behavior, University of Buffalo, Buffalo NY 14214, USA.'}, {'ForeName': 'Regan L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'Professor, Department of Nutrition Science, Purdue University, West Lafayette, IN 47907, USA, (phone) 765-494-2829, (fax) 765-494-0674.'}, {'ForeName': 'Lacey A', 'Initials': 'LA', 'LastName': 'McCormack', 'Affiliation': 'Associate Professor, Health and Nutritional Sciences, South Dakota State University, Brookings, SD 57007, USA, (phone) 605-688-4046.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Stluka', 'Affiliation': 'Division Director, United States Department of Agriculture, National Institute of Food & Agriculture, , Kansas City, MO 64105, USA, (phone) 816-908-3305.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Franzen-Castle', 'Affiliation': 'Associate Professor & Extension Nutrition Specialist, Nutrition and Health Sciences, University of Nebraska-Lincoln, Lincoln, NE 68583, USA.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Henne', 'Affiliation': 'Associate Program Leader, SNAP-Ed Coordinator, Michigan State University Extension, ,1800 Imlay City Road, Suite One, Lapeer, MI 48446, USA, (phone) 810-667-0341, (fax) 810-667-0355.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mehrle', 'Affiliation': 'Specialist, Extension, University of Missouri, Columbia, MO 65212, USA, (phone) 573-659-1728, (fax) 573-884-5412.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Remley', 'Affiliation': 'Associate Professor, Extension, Ohio State University, Piketon, OH 45661, USA, (phone) 740-289-2071 ext. 241.'}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2022.02.016']
3008,35231662,Feasibility of Implementing a Food Skills Intervention.,"BACKGROUND


Food skills are defined as meal planning, preparation, shopping, budgeting, resourcefulness, and label reading/consumer awareness. To date, food skills have not been tested in intervention-based studies.
OBJECTIVE


To evaluate the feasibility of implementing a food skills intervention.
DESIGN


This was an eight-week prospective food skills intervention. Study measures were completed through questionnaires provided prior to the start of the intervention and after the intervention was completed. For questionnaires, the web platform REDCap was used.
PARTICIPANTS AND SETTING


Thirty parents (≥18 years) with at least one child (2-12 years), attended weekly virtual intervention sessions via Zoom. The intervention took place from August to October 2020 with assessment measures collected within two months of the start and end date of the intervention. Participants were from the mid-Atlantic region of the U.S.
INTERVENTION


A food skills intervention based upon behavior modification strategies from the Social Cognitive Theory was implemented. Intervention goals included meal planning (six of seven dinner meals per week), meal plan implementation (at least four of six planned dinner meals), and always using a grocery list when shopping.
MAIN OUTCOMES


Feasibility was evaluated based upon parent attendance, number of self-monitoring booklets completed, adherence to goals, implementation fidelity, and qualitative responses to interviews. Change in food skills confidence and nutrition knowledge were also assessed.
ANALYSIS


Descriptive statistics and qualitative responses were used to describe feasibility. Paired t-tests were used to evaluate change in food skills confidence and nutrition knowledge from baseline to eight-weeks.
RESULTS


Parents attended a mean of 7.6 ± 1.0 (of 8) sessions and completed a mean of 6.2 ± 1.7 (of 7) self-monitoring booklets. Parents planned a mean of 6.1 ± 1.5 dinners/week and implemented a mean of 4.7 ± 1.6 of the six planned dinners, achieving the intervention goals. Of the mean 1.2 ± 0.6 trips/week to the grocery store reported, grocery lists were used a mean of 1.1 ± 0.6 times. Mean food skills confidence score increased significantly from baseline to eight-weeks (baseline: 86.5 ± 18.0; eight-weeks: 101.4 ± 15.3; p<0.001). Mean nutrition knowledge score also significantly increased (baseline: 64.1 ± 7.2; eight-weeks: 69.1 ± 6.6, p<0.001). Parents reported on a scale of zero (""easy"") to 10 (""difficult"") a mean difficulty rating of 2.4 ± 2.4 for meal planning, a mean of 2.1 ± 2.1 for meal plan implementation and a mean of 1.0 ± 1.7 for always using a grocery shopping list indicating acceptability of goals.
CONCLUSION


Feasibility of a food skills intervention was demonstrated by high session attendance, high numbers of self-monitoring booklets turned in, high achievement of intervention goals, parent acceptability, and high ratings of implementation fidelity. There was an increase in food skill confidence and nutrition knowledge. Future research should examine the efficacy of changing food skill behaviors on dietary intake.",2022,"Mean nutrition knowledge score also significantly increased (baseline: 64.1 ± 7.2; eight-weeks: 69.1 ± 6.6, p<0.001).","['Thirty parents (≥18 years) with at least one child (2-12 years), attended weekly virtual intervention sessions via Zoom']","['Food Skills Intervention', 'meal planning (six of seven dinner meals per week), meal plan implementation', 'food skills intervention based upon behavior modification strategies from the Social Cognitive Theory was implemented', 'food skills intervention']","['Change in food skills confidence and nutrition knowledge', 'Mean food skills confidence score', 'Mean nutrition knowledge score', 'food skill confidence and nutrition knowledge', 'parent attendance, number of self-monitoring booklets completed, adherence to goals, implementation fidelity, and qualitative responses to interviews', 'food skills confidence and nutrition knowledge']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0596014', 'cui_str': 'Does plan meals'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]",,0.0133985,"Mean nutrition knowledge score also significantly increased (baseline: 64.1 ± 7.2; eight-weeks: 69.1 ± 6.6, p<0.001).","[{'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Fultz', 'Affiliation': 'Department of Behavioral Health and Nutrition, University of Delaware; Center for Health Behavior Research, Perelman School of Medicine, University of Pennsylvania. Electronic address: Amanda.fultz@pennmedicine.upenn.edu.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'Department of Behavioral Health and Nutrition, University of Delaware. Electronic address: Amanda.fultz@pennmedicine.upenn.edu.'}, {'ForeName': 'Elizabeth Anderson', 'Initials': 'EA', 'LastName': 'Steeves', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Trabulsi', 'Affiliation': 'Department of Behavioral Health and Nutrition, University of Delaware.'}, {'ForeName': 'Adriana Verdezoto', 'Initials': 'AV', 'LastName': 'Alvarado', 'Affiliation': 'Department of Behavioral Health and Nutrition, University of Delaware.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Robson', 'Affiliation': 'Department of Behavioral Health and Nutrition, University of Delaware.'}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2022.02.015']
3009,35231608,Daily prefrontal closed-loop repetitive transcranial magnetic stimulation (rTMS) produces progressive EEG quasi-alpha phase entrainment in depressed adults.,"BACKGROUND


Transcranial magnetic stimulation (TMS) is a non-invasive neuromodulation modality that can treat depression, obsessive-compulsive disorder, or help smoking cessation. Research suggests that timing the delivery of TMS relative to an endogenous brain state may affect efficacy and short-term brain dynamics.
OBJECTIVE


To investigate whether, for a multi-week daily treatment of repetitive TMS (rTMS), there is an effect on brain dynamics that depends on the timing of the TMS relative to individuals' prefrontal EEG quasi-alpha rhythm (between 6 and 13 Hz).
METHOD


We developed a novel closed-loop system that delivers personalized EEG-triggered rTMS to patients undergoing treatment for major depressive disorder. In a double blind study, patients received daily treatments of rTMS over a period of six weeks and were randomly assigned to either a synchronized or unsynchronized treatment group, where synchronization of rTMS was to their prefrontal EEG quasi-alpha rhythm.
RESULTS


When rTMS is applied over the dorsal lateral prefrontal cortex (DLPFC) and synchronized to the patient's prefrontal quasi-alpha rhythm, patients develop strong phase entrainment over a period of weeks, both over the stimulation site as well as in a subset of areas distal to the stimulation site. In addition, at the end of the course of treatment, this group's entrainment phase shifts to be closer to the phase that optimally engages the distal target, namely the anterior cingulate cortex (ACC). These entrainment effects are not observed in the group that is given rTMS without initial EEG synchronization of each TMS train.
CONCLUSIONS


The entrainment effects build over the course of days/weeks, suggesting that these effects engage neuroplastic changes which may have clinical consequences in depression or other diseases.",2022,"These entrainment effects are not observed in the group that is given rTMS without initial EEG synchronization of each TMS train.
","['patients undergoing treatment for major depressive disorder', 'depressed adults']","['Daily prefrontal closed-loop repetitive transcranial magnetic stimulation (rTMS', 'personalized EEG-triggered rTMS', 'Transcranial magnetic stimulation (TMS', 'repetitive TMS (rTMS', 'rTMS', 'synchronized or unsynchronized treatment group, where synchronization of rTMS was to their prefrontal EEG quasi-alpha rhythm']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002219', 'cui_str': 'Alpha Rhythm'}]",[],,0.0189215,"These entrainment effects are not observed in the group that is given rTMS without initial EEG synchronization of each TMS train.
","[{'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Faller', 'Affiliation': 'Department of Biomedical Engineering, Columbia University, New York, NY, 10027, USA.'}, {'ForeName': 'Jayce', 'Initials': 'J', 'LastName': 'Doose', 'Affiliation': 'Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Biomedical Engineering, Columbia University, New York, NY, 10027, USA; US DEVCOM Army Research Laboratory, Aberdeen Proving Ground, MD, 20115, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Mclntosh', 'Affiliation': 'Department of Biomedical Engineering, Columbia University, New York, NY, 10027, USA; Department of Orthopaedic Surgery, Columbia University Irving Medical Center, New York, NY, 10032, USA.'}, {'ForeName': 'Golbarg T', 'Initials': 'GT', 'LastName': 'Saber', 'Affiliation': 'Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, 29425, USA; Department of Neurology, University of Chicago, Chicago, IL, 60637, USA.'}, {'ForeName': 'Yida', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Computer Science, Columbia University, New York, NY, 10027, USA.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Teves', 'Affiliation': 'Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Aidan', 'Initials': 'A', 'LastName': 'Blankenship', 'Affiliation': 'Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Huffman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Robin I', 'Initials': 'RI', 'LastName': 'Goldman', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin-Madison, Madison, WI, 53705, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Truman R', 'Initials': 'TR', 'LastName': 'Brown', 'Affiliation': 'Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA; Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sajda', 'Affiliation': 'Department of Biomedical Engineering, Columbia University, New York, NY, 10027, USA; Department of Radiology, Columbia University Irving Medical Center, New York, NY, 10032, USA; Department of Electrical Engineering, Columbia University, New York, NY, 10027, USA; Data Science Institute, Columbia University, New York, NY, 10027, USA. Electronic address: ps629@columbia.edu.'}]",Brain stimulation,['10.1016/j.brs.2022.02.008']
3010,35236652,Efficacy and safety of bevacizumab combined with chemotherapy in the treatment of advanced colorectal cancer and the effect on its adverse reactions.,"To evaluate the efficacy and safety of bevacizumab combined with chemotherapy in the treatment of advanced colorectal cancer and the effect on its adverse reactions, 100 patients with advanced colorectal cancer admitted to our hospital from March 2019 to March 2021 were identified as study subjects and were randomly divided into a control group and an experimental group, with 50 cases in each group. The control group was treated with chemotherapy, and the experimental group was given a combination of bevacizumab with chemotherapy. The treatment efficacy, safety, and incidence of adverse reactions in both groups were analyzed and compared. The effectiveness and disease control rate of the experimental group were 50% and 96%, which were significantly higher than those of 26% and 80% in the control group (P<0.05). After treatment, the experimental group exhibited a significantly lower serum vascular endothelial growth factor level and heat shock protein 90α (HSP90α) level compared with that of the control group (P<0.05). Markedly higher apoptosis index of tumor cells was observed in the experimental group than in the control group (P<0.05). The incidence of adverse reactions was 8% in the experimental group, which was significantly lower than that of 28% in the control group (P<0.05). The post-treatment quality of life scores in the experimental group exceeded that in the control group (P<0.05). Bevacizumab combined with chemotherapy for advanced colorectal cancer boosts treatment efficiency, promotes apoptosis of tumor cells, down regulates HSP90α level and enhances patients' quality of life with high safety, which is worthy of clinical promotion and application.",2022,The post-treatment quality of life scores in the experimental group exceeded that in the control group (P<0.05).,"['100 patients with advanced colorectal cancer admitted to our hospital from March 2019 to March 2021 were identified as study subjects', 'advanced colorectal cancer']","['bevacizumab combined with chemotherapy', 'chemotherapy', 'Bevacizumab combined with chemotherapy', 'bevacizumab with chemotherapy']","['incidence of adverse reactions', 'apoptosis index of tumor cells', 'efficacy and safety', 'Efficacy and safety', 'serum vascular endothelial growth factor level and heat shock protein 90α (HSP90α) level', 'treatment efficacy, safety, and incidence of adverse reactions', 'effectiveness and disease control rate', 'post-treatment quality of life scores']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018850', 'cui_str': 'Heat-Shock Protein'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.0243521,The post-treatment quality of life scores in the experimental group exceeded that in the control group (P<0.05).,"[{'ForeName': 'Wenen', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Oncology, First Hospital of Qinhuangdao, Qinhuangdao, Hebei, China.'}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Department of Oncology, First Hospital of Qinhuangdao, Qinhuangdao, Hebei, China.'}, {'ForeName': 'Lusheng', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'General Medicine, First Hospital of Qinhuangdao, Qinhuangdao, Hebei, China.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'General Medicine, First Hospital of Qinhuangdao, Qinhuangdao, Hebei, China.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, First Hospital of Qinhuangdao, Qinhuangdao, Hebei, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, First Hospital of Qinhuangdao, Qinhuangdao, Hebei, China.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, First Hospital of Qinhuangdao, Qinhuangdao, Hebei, China.'}]",Pakistan journal of pharmaceutical sciences,[]
3011,35236650,The effects of levothyroxine combined with methimazole on the clinical efficacy of hyperthyroidism treatment.,"To investigate the effects of levothyroxine combined with methimazole on the clinical efficacy of hyperthyroidism treatment. A total of 102 patients with hyperthyroidism admitted to our hospital from January 2018 to June 2020 were selected and randomly assigned into the combination group (levothyroxine combined with methimazole) and the control group (methimazole treatment alone). 3 months after treatment, the two groups were compared with regard to clinical efficacy, changes in ultrasound findings, the thyroid hormones, and serum indexes and the adverse reactions rate. The combination group (98.04%) outperformed the control group (86.27%) in total effective rate, and the overall efficacy garnered the similar result. After treatment, the combination group showed advantages in thyroid hormone level, serum index level, thyroid volume, superior thyroid artery diameter, and maximum blood flow rate when compared with those of the control group (P<0.05). As for the adverse reactions rate, the combination group was superior to the control group (3.92%vs15.69%) (P<0.05). Levothyroxine combined with methimazole promotes the clinical efficacy of hyperthyroidism treating, reduces thyroid volume and the diameter of superior thyroid artery, enhances the patient's thyroid function and serum index, with higher safety profile.",2022,"After treatment, the combination group showed advantages in thyroid hormone level, serum index level, thyroid volume, superior thyroid artery diameter, and maximum blood flow rate when compared with those of the control group (P<0.05).",['102 patients with hyperthyroidism admitted to our hospital from January 2018 to June 2020'],"['control group (methimazole treatment alone', 'combination group (levothyroxine combined with methimazole', 'levothyroxine combined with methimazole', 'Levothyroxine']","['adverse reactions rate', 'advantages in thyroid hormone level, serum index level, thyroid volume, superior thyroid artery diameter, and maximum blood flow rate', 'total effective rate', 'clinical efficacy, changes in ultrasound findings, the thyroid hormones, and serum indexes and the adverse reactions rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020550', 'cui_str': 'Hyperthyroidism'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025644', 'cui_str': 'Methimazole'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0226093', 'cui_str': 'Structure of superior thyroid artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1299966', 'cui_str': 'Ultrasound scan finding'}]",102.0,0.0312586,"After treatment, the combination group showed advantages in thyroid hormone level, serum index level, thyroid volume, superior thyroid artery diameter, and maximum blood flow rate when compared with those of the control group (P<0.05).","[{'ForeName': 'Lijing', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Endocrine Department, The Fourth Central Hospital of Baoding City, BaoDing City, Hebei Province, China.'}, {'ForeName': 'Liguo', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'The Fourth Central Hospital of Baoding City, BaoDing City, Hebei Province, China.'}, {'ForeName': 'Yaqin', 'Initials': 'Y', 'LastName': 'An', 'Affiliation': 'Endocrine Department, The Fourth Central Hospital of Baoding City, BaoDing City, Hebei Province, China.'}, {'ForeName': 'Minghua', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Endocrine Department, The Fourth Central Hospital of Baoding City, BaoDing City, Hebei Province, China.'}, {'ForeName': 'Bingjie', 'Initials': 'B', 'LastName': 'Hou', 'Affiliation': 'Department of Internal medicine, The Fourth Central Hospital of Baoding City, Bao Ding City, Hebei Province, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Endocrine Department, The Fourth Central Hospital of Baoding City, BaoDing City, Hebei Province, China.'}]",Pakistan journal of pharmaceutical sciences,[]
3012,35236649,Effect of Jiawei qingxuan jiangya decoction on blood pressure variability and sex hormone levels in perimenopausal female patients with hypertension.,"To explore the effect of Jiawei Qingxuan Jiangya Decoction on blood pressure variability and sex hormone levels in perimenopausal women with hypertension. A total of 400 perimenopausal female hypertensive patients admitted to the hospital from June 2019 to June 2020 were randomly divided into observation group and control group, with 200 cases in each group. The patients in the control group took orally benazepril hydrochloride tablets, and the observation group was added with Jiawei Qingxuan Jiangya Decoction on the basis of the control group. The course of treatment was 1 month. The clinical efficacy of the two groups and the 24h blood pressure variability (BPV) and sex hormone levels before and after treatment were compared. The total effective rate of the observation group was significantly higher than that of the control group (P<0.05); the 24h BPV of the two groups after treatment was significantly lower than that before the treatment, and the reduction in the observation group was greater (P<0.05); the serum estradiol in the observation group after treatment was significantly increased, and the level of follicle stimulating hormone was significantly reduced, and compared with the control group after treatment, the difference was statistically significant (P<0.05). Jiawei Qingxuan Jiangya Decoction for treating hypertension in perimenopausal women can effectively reduce blood pressure, improve short-term blood pressure variability, regulate sex hormone levels to a certain extent, and correct endocrine disorders. It is worthy of clinical promotion.",2022,"The total effective rate of the observation group was significantly higher than that of the control group (P<0.05); the 24h BPV of the two groups after treatment was significantly lower than that before the treatment, and the reduction in the observation group was greater (P<0.05); the serum estradiol in the observation group after treatment was significantly increased, and the level of follicle stimulating hormone was significantly reduced, and compared with the control group after treatment, the difference was statistically significant (P<0.05).","['perimenopausal women', 'perimenopausal female patients with hypertension', 'perimenopausal women with hypertension', '400 perimenopausal female hypertensive patients admitted to the hospital from June 2019 to June 2020']","['Jiawei Qingxuan Jiangya Decoction', 'Jiawei qingxuan jiangya decoction', 'benazepril hydrochloride tablets']","['total effective rate', 'blood pressure variability and sex hormone levels', 'serum estradiol', 'level of follicle stimulating hormone', '24h blood pressure variability (BPV) and sex hormone levels', 'blood pressure']","[{'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0770917', 'cui_str': 'Benazepril hydrochloride'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}]",,0.0252589,"The total effective rate of the observation group was significantly higher than that of the control group (P<0.05); the 24h BPV of the two groups after treatment was significantly lower than that before the treatment, and the reduction in the observation group was greater (P<0.05); the serum estradiol in the observation group after treatment was significantly increased, and the level of follicle stimulating hormone was significantly reduced, and compared with the control group after treatment, the difference was statistically significant (P<0.05).","[{'ForeName': 'Yaqin', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Yuncheng Central Hospital, Hedong Street, Yanhu District, Yuncheng City, Shanxi Province, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Yuncheng Central Hospital, Hedong Street, Yanhu District, Yuncheng City, Shanxi Province, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Yuncheng Central Hospital, Hedong Street, Yanhu District, Yuncheng City, Shanxi Province, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Yuncheng Central Hospital, Hedong Street, Yanhu District, Yuncheng City, Shanxi Province, China.'}]",Pakistan journal of pharmaceutical sciences,[]
3013,35236648,Aminophylline in combination with caffeine citrate in neurodevelopmental treatment and follow-up of high-risk preterm infants using GMs assessment.,"To explore the application effect of aminophylline combined with caffeine citrate and GMs in the evaluation of neurodevelopmental treatment and follow-up in high-risk preterm infants. A retrospective analysis of 66 high-risk preterm infants admitted to Hengshui People's Hospital from January 2020 to June 2021 was conducted. The children who received only conventional treatment were set as the control group, while those who received aminophylline and caffeine citrate on the basis of conventional treatment were set as the experimental group, 33 cases each group; GMs were used to evaluate the neurodevelopmental function of the children, and the treatment effect was analyzed. The normal proportion of GMs assessment results in the twisting phase and restless movement phase of the experimental group was superior to the control group (P<0.05); The proportion of children with normal neurodevelopment in the experimental group was significantly higher than that in the control group (P<0.05). Aminophylline in combination with caffeine citrate can help promote the neurodevelopment of children and improve their physical health using GMs assessment in the treatment and follow-up of high-risk preterm infants.",2022,The normal proportion of GMs assessment results in the twisting phase and restless movement phase of the experimental group was superior to the control group (P<0.05); The proportion of children with normal neurodevelopment in the experimental group was significantly higher than that in the control group (P<0.05).,"[""66 high-risk preterm infants admitted to Hengshui People's Hospital from January 2020 to June 2021 was conducted"", 'high-risk preterm infants']","['aminophylline combined with caffeine citrate and GMs', 'aminophylline and caffeine citrate', 'Aminophylline', 'caffeine citrate']",['proportion of children with normal neurodevelopment'],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0002575', 'cui_str': 'Aminophylline'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0054436', 'cui_str': 'Caffeine citrate'}]","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]",,0.0169135,The normal proportion of GMs assessment results in the twisting phase and restless movement phase of the experimental group was superior to the control group (P<0.05); The proportion of children with normal neurodevelopment in the experimental group was significantly higher than that in the control group (P<0.05).,"[{'ForeName': 'Wenjiao', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Child Health, Shiyan Maternal and Child Health Hospital, Shiyan, Hubei, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zheng', 'Affiliation': 'Department of Pediatrics, Affiliated Taihe Hospital of Hubei University of Medicine, Shiyan, Hubei, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Maternal and Child Health Care, Shiyan Maternal and Child Health Hospital, Shiyan, Hubei, China.'}]",Pakistan journal of pharmaceutical sciences,[]
3014,35231791,Intermittent theta burst stimulation improved visual-spatial working memory in treatment-resistant schizophrenia: A pilot study.,"BACKGROUND


Visual-spatial working memory (vsWM) impairment in treatment-resistant schizophrenia (TRS) currently has no satisfactory treatment. Our study aimed to improve vsWM function in TRS through intermittent theta burst stimulation (iTBS) using neuronavigation equipment to target the left dorsolateral prefrontal cortex.
METHOD


TRS patients (n = 59) were randomly allocated to receive iTBS (n = 33) or a sham treatment (n = 26) over 2 weeks. The participants including TRS patients and healthy controls (HCs) performed the vsWM n-back task, and TRS patients' neuroimaging data were acquired before and after treatment. All patients also underwent a battery of symptom measures to assess the severity of illness. The main outcome measure was the accuracy (ACC) of n-back target responses, particularly 3-back ACC.
RESULTS


The iTBS group showed considerable improvement in n-back ACC compared to the sham group, especially 3-back ACC. After iTBS, performance on the n-back task was comparable to that of HCs. The interaction (group × time) results showed increased fractional amplitude of low frequency fluctuations (fALFF) in the right occipital areas and decreased fALFF in the right precuneus. However, there was a negative correlation between the 3-back ACC and improved clinical symptoms scores. Improvements in 3-back ACC were positively correlated with activity in the right visual cortex.
CONCLUSIONS


Our study suggested that 2 weeks of iTBS intervention may be a novel, efficacious treatment for vsWM deficits in TRS, which can modulate the activity of local brain regions. iTBS can provide a solution for clinical treatment of TRS and may help patients approach normalcy.",2022,"The iTBS group showed considerable improvement in n-back ACC compared to the sham group, especially 3-back ACC.","['treatment-resistant schizophrenia', 'TRS patients (n\xa0=\xa059']","['iTBS intervention', 'iTBS', 'TRS through intermittent theta burst stimulation (iTBS) using neuronavigation equipment', 'Intermittent theta burst stimulation']","['fractional amplitude of low frequency fluctuations (fALFF', 'clinical symptoms scores', 'severity of illness', 'accuracy (ACC) of n-back target responses, particularly 3-back ACC', 'visual-spatial working memory']","[{'cui': 'C3544321', 'cui_str': 'Treatment-resistant schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3544321', 'cui_str': 'Treatment-resistant schizophrenia'}, {'cui': 'C1136207', 'cui_str': 'Frameless Stereotaxy'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",59.0,0.033056,"The iTBS group showed considerable improvement in n-back ACC compared to the sham group, especially 3-back ACC.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Hefei, China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Hefei, China; Department of Psychiatry, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Hefei, China.'}, {'ForeName': 'Gong-Jun', 'Initials': 'GJ', 'LastName': 'Ji', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China; School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Hefei, China.'}, {'ForeName': 'Xingqi', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Hefei, China.'}, {'ForeName': 'Guixian', 'Initials': 'G', 'LastName': 'Xiao', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Hefei, China.'}, {'ForeName': 'Bensheng', 'Initials': 'B', 'LastName': 'Qiu', 'Affiliation': 'Centers for Biomedical Engineering, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Hu', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Hefei, China.'}, {'ForeName': 'Xingui', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Hefei, China. Electronic address: chen_xin_gui@126.com.'}, {'ForeName': 'Kongliang', 'Initials': 'K', 'LastName': 'He', 'Affiliation': 'Anhui Mental Health Center, Hefei, China. Electronic address: hefei413@126.com.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, China; School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China; Institute of Artificial Intelligence, Hefei Comprehensive National Science Center, Hefei, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Hefei, China; Anhui Provincial Institute of Translational Medicine, Anhui Medical University, Hefei, China. Electronic address: wangkai1964@126.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2022.02.019']
3015,35231721,A trial of online ABRACADABRA literacy instruction with supplementary parent-led shared book reading for children with autism.,"BACKGROUND/AIMS


The COVID-19 pandemic has highlighted the need for accessible support for children with developmental disabilities. This study explored online literacy instruction with supplementary parent-led shared book reading (SBR) for children with autism.
METHODS


Twenty-one children with autism (5-12 years) completed a battery of assessments (T1) before being assigned to ability matched Instruction (n = 10) and Control groups (n = 11). Instruction group participants completed 16 h of ABRACADABRA instruction working with a researcher 1:1 online and SBR activities at home with a parent over 8 weeks. All participants were reassessed after the instruction period (T2) and parents of children in the Instruction group were interviewed regarding their views and experiences.
RESULTS


Quantitative analyses showed no significant improvements in reading for Instruction group children relative to Control group children. However, each child successfully participated in 16 online instruction sessions and qualitative data revealed that parents were generally positive about the program, with some observing improvements in their child's literacy skills and reading confidence.
CONCLUSIONS AND IMPLICATIONS


While it appears children with autism can participate in online literacy instruction, sixteen hours of online ABRACADABRA instruction with parent-led SBR may not be effective in improving their reading skills. Further research is required to explore whether more intensive and/or extended online instruction may be feasible and effective, and to improve uptake of parent-led book reading activities at home.",2022,"RESULTS


Quantitative analyses showed no significant improvements in reading for Instruction group children relative to Control group children.","['Twenty-one children with autism (5-12 years) completed a battery of assessments (T1) before being assigned to ability matched Instruction (n = 10) and Control groups (n = 11', 'children with autism', 'children with developmental disabilities']","['online literacy instruction with supplementary parent-led shared book reading (SBR', 'literacy instruction with supplementary parent-led shared book reading']","[""child's literacy skills and reading confidence""]","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}]","[{'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",21.0,0.0566018,"RESULTS


Quantitative analyses showed no significant improvements in reading for Instruction group children relative to Control group children.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Bailey', 'Affiliation': 'Caring Futures Institute and College of Nursing and Health Sciences, Flinders University, Australia.'}, {'ForeName': 'Darryl', 'Initials': 'D', 'LastName': 'Sellwood', 'Affiliation': 'Caring Futures Institute and College of Nursing and Health Sciences, Flinders University, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Rillotta', 'Affiliation': 'Caring Futures Institute and College of Nursing and Health Sciences, Flinders University, Australia.'}, {'ForeName': 'Pammi', 'Initials': 'P', 'LastName': 'Raghavendra', 'Affiliation': 'Caring Futures Institute and College of Nursing and Health Sciences, Flinders University, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Arciuli', 'Affiliation': 'Caring Futures Institute and College of Nursing and Health Sciences, Flinders University, Australia. Electronic address: joanne.arciuli@flinders.edu.au.'}]",Research in developmental disabilities,['10.1016/j.ridd.2022.104198']
3016,35232229,Efficacy and safety of electroacupuncture for post-stroke depression: a randomized controlled trial.,"OBJECTIVE


The objective of this study is to evaluate the efficacy and safety of electroacupuncture (EA) treatment for post-stroke depression (PSD).
METHODS


This study was a single-center, single-blinded, parallel-arm randomized controlled trial. In total, 65 patients with PSD were randomly allocated into EA and sham EA groups. Treatment was administered at GV20,  Sishencong , SP6, LR3 and BL18 in both groups. The EA group received EA treatment, while the sham EA group received sham EA treatment using the Park device. Treatment was given three times a week for 4 weeks. The primary outcome was the Hamilton Rating Scale for Depression (HRSD). Secondary outcomes included the Zung Self-Rating Depression Scale (SDS), National Institutes of Health Stroke Scale (NIHSS), Barthel Daily Living Index (BI) and depression scale of traditional Chinese medicine (TCM). Primary and secondary outcomes were assessed at baseline, week 2 after treatment, week 4 after treatment and week 8 of follow-up. Safety assessment was conducted at each visit for 4 weeks of treatment.
RESULTS


Significant differences in HRSD, SDS, NIHSS, BI and TCM scale scores were found in the EA group before and after acupuncture treatment (all p < 0.001). Compared with the sham EA group, HRSD scores improved significantly in the EA group at the end of week 2 (F = 31.33, p < 0.001), week 4 (F = 35.58, p < 0.001) and week 8 after treatment onset (F = 25.03, p < 0.001). Similarly, significant improvements were observed in SDS, NIHSS and BI scores. Two participants in the EA group suffered a local hematoma, while no adverse events were reported in the sham EA group.
CONCLUSION


EA appears to be an efficacious and safe treatment for PSD. According to our results, EA may alleviate depressive symptoms, and improve neurological function and capabilities with respect to activities of daily living (ADLs).
TRIAL REGISTRATION NUMBER


ChiCTR-IOR-17012610 (Chinese Clinical Trial Registry).",2022,"RESULTS


Significant differences in HRSD, SDS, NIHSS, BI and TCM scale scores were found in the EA group before and after acupuncture treatment (all p < 0.001).","['65 patients with PSD', 'post-stroke depression', 'post-stroke depression (PSD']","['sham EA', 'EA', 'electroacupuncture (EA', 'electroacupuncture', 'EA and sham EA']","['HRSD, SDS, NIHSS, BI and TCM scale scores', 'neurological function and capabilities with respect to activities of daily living (ADLs', 'Zung Self-Rating Depression Scale (SDS), National Institutes of Health Stroke Scale (NIHSS), Barthel Daily Living Index (BI) and depression scale of traditional Chinese medicine (TCM', 'local hematoma', 'SDS, NIHSS and BI scores', 'Hamilton Rating Scale for Depression (HRSD', 'efficacy and safety', 'Efficacy and safety', 'HRSD scores', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2938940', 'cui_str': 'Post stroke depression'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451593', 'cui_str': 'Zung self-rating depression scale'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",65.0,0.448352,"RESULTS


Significant differences in HRSD, SDS, NIHSS, BI and TCM scale scores were found in the EA group before and after acupuncture treatment (all p < 0.001).","[{'ForeName': 'Wa', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Department of Acupuncture, Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Acupuncture, Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yi-Jing', 'Initials': 'YJ', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture, Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Guan-Tao', 'Initials': 'GT', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture, Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Gynecology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Shen', 'Affiliation': 'Department of Acupuncture, Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/09645284221077104']
3017,35232217,Screening for Atrial Fibrillation in Older Adults at Primary Care Visits: the VITAL-AF Randomized Controlled Trial.,"Background:  Undiagnosed atrial fibrillation (AF) may cause preventable strokes. Guidelines differ regarding AF screening recommendations. We tested whether point-of-care screening with a handheld single lead electrocardiogram (ECG) at primary care practice visits increases diagnoses of AF.  Methods:  We randomized 16 primary care clinics 1:1 to AF screening using a handheld single-lead ECG (AliveCor KardiaMobile) during vital sign assessments, or usual care. Patients included were aged ≥65 years. Screening results were provided to primary care clinicians at the encounter. All confirmatory diagnostic testing and treatment decisions were made by the primary care clinician. New AF diagnoses over one-year follow-up were ascertained electronically and manually adjudicated. Proportions and incidence rates were calculated. Effect heterogeneity was assessed.  Results:  Of 30,715 patients without prevalent AF (n=15,393 screening [91% screened], n=15,322 control), 1.72% of individuals in the screening group had new AF diagnosed at one year versus 1.59% in the control group (risk difference [RD] 0.13%, 95% confidence interval [CI] -0.16-0.42, P=0.38). In prespecified subgroup analyses, new AF diagnoses in the screening and control groups were greater among those aged ≥85 years (5.56% versus 3.76%, respectively, RD 1.80%, 95% CI 0.18-3.30). The difference in newly diagnosed AF between the screening period and the prior year was marginally greater in the screening versus control group (0.32% versus -0.12%, RD 0.43%, 95% CI -0.01-0.84). The proportion of individuals with newly diagnosed AF who were initiated on oral anticoagulants was not different in the screening (n=194, 73.5%) and control (n=172, 70.8%) arms (RD 2.7%, 95% CI -5.5-10.4).  Conclusions:  Screening for AF using a single-lead ECG at primary care visits did not affect new AF diagnoses among all individuals aged 65 years or older compared to usual care.",2022,"The difference in newly diagnosed AF between the screening period and the prior year was marginally greater in the screening versus control group (0.32% versus -0.12%, RD 0.43%, 95% CI -0.01-0.84).","['Patients included were aged ≥65 years', 'Older Adults at Primary Care Visits', 'individuals aged 65 years or older compared to usual care']","['AF screening using a handheld single-lead ECG (AliveCor KardiaMobile) during vital sign assessments, or usual care', 'point-of-care screening with a handheld single lead electrocardiogram (ECG']","['new AF diagnoses', 'Proportions and incidence rates', 'new AF diagnosed']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0179504', 'cui_str': 'ECG lead'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0199557', 'cui_str': 'Electrocardiogram, single lead'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",16.0,0.147824,"The difference in newly diagnosed AF between the screening period and the prior year was marginally greater in the screening versus control group (0.32% versus -0.12%, RD 0.43%, 95% CI -0.01-0.84).","[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Lubitz', 'Affiliation': 'Demoulas Center for Cardiac Arrhythmias and Cardiovascular Research Center, Massachusetts General Hospital, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Atlas', 'Affiliation': 'Harvard Medical School, Boston, MA; Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Ashburner', 'Affiliation': 'Harvard Medical School, Boston, MA; Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Ana T', 'Initials': 'AT', 'LastName': 'Trisini Lipsanopoulos', 'Affiliation': 'Division of Cardiology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Leila H', 'Initials': 'LH', 'LastName': 'Borowsky', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Wyliena', 'Initials': 'W', 'LastName': 'Guan', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Shaan', 'Initials': 'S', 'LastName': 'Khurshid', 'Affiliation': 'Demoulas Center for Cardiac Arrhythmias and Cardiovascular Research Center, Massachusetts General Hospital, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Ellinor', 'Affiliation': 'Demoulas Center for Cardiac Arrhythmias and Cardiovascular Research Center, Massachusetts General Hospital, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Harvard Medical School, Boston, MA; Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'McManus', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School, Worcester, MA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Singer', 'Affiliation': 'Harvard Medical School, Boston, MA; 3Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}]",Circulation,['10.1161/CIRCULATIONAHA.121.057014']
3018,35232215,A Head-to-Head Comparison of a Free Fatty Acid Formulation of Omega-3 Pentaenoic Acids Versus Icosapent Ethyl in Adults With Hypertriglyceridemia: The ENHANCE-IT Study.,"Background MAT9001 is an omega-3 free fatty acid (FFA) formulation containing mainly eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA). Compared with icosapent ethyl (EPA-ethyl esters [EE]), EPA+DPA-FFA previously showed enhanced triglyceride lowering and higher plasma EPA when both were administered once daily with a very-low fat diet. This trial compared pharmacodynamic responses and plasma omega-3 levels following twice daily dosing, with meals, of EPA+DPA-FFA and EPA-EE in hypertriglyceridemic subjects consuming a Therapeutic Lifestyle Changes diet. Methods and Results This open-label, randomized, 2-way crossover trial, with 28-day treatment periods separated by ≥28-day washout, was conducted at 8 US centers and included 100 subjects with fasting triglycerides 1.70 to 5.64 mmol/L (150-499 mg/dL) (median 2.31 mmol/L [204 mg/dL]; 57% women, average age 60.3 years). The primary end point was least squares geometric mean percent change from baseline plasma triglycerides. In the 94 subjects with analyzable data for both treatment periods, EPA+DPA-FFA and EPA-EE reduced least squares geometric mean triglycerides from baseline: 20.9% and 18.3%, respectively ( P =not significant). EPA+DPA-FFA reduced least squares geometric mean high-sensitivity C-reactive protein by 5.8%; EPA-EE increased high-sensitivity C-reactive protein by 8.5% ( P =0.034). EPA+DPA-FFA increased least squares geometric mean plasma EPA, DPA, and total omega-3 (EPA+docosahexaenoic acid+DPA) concentrations by 848%, 177%, and 205%, respectively, compared with corresponding changes with EPA-EE of 692%, 140%, and 165% (all  P <0.001). EPA+DPA-FFA increased docosahexaenoic acid by 1.7%; EPA-EE decreased docosahexaenoic acid by 3.3% ( P =0.011). Lipoprotein cholesterol and apolipoprotein responses did not differ between treatments. Conclusions EPA+DPA-FFA raised plasma EPA, DPA, and total omega-3 significantly more than did EPA-EE. EPA+DPA-FFA also reduced triglycerides and high-sensitivity C-reactive protein without increasing low-density lipoprotein cholesterol. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04177680.",2022,EPA+DPA-FFA also reduced triglycerides and high-sensitivity C-reactive protein without increasing low-density lipoprotein cholesterol.,"['57% women, average age 60.3\xa0years', 'Adults With Hypertriglyceridemia', '100 subjects with fasting triglycerides 1.70 to 5.64\xa0mmol/L (150-499\xa0mg/dL) (median 2.31\xa0mmol/L', 'hypertriglyceridemic subjects consuming a Therapeutic Lifestyle Changes diet']","['icosapent ethyl (EPA-ethyl esters [EE]), EPA+DPA-FFA', 'EPA+DPA-FFA and EPA-EE', 'dL', 'Free Fatty Acid Formulation of Omega-3 Pentaenoic Acids Versus Icosapent Ethyl', 'EPA+DPA-FFA']","['least squares geometric mean percent change from baseline plasma triglycerides', 'Lipoprotein cholesterol and apolipoprotein responses', 'EPA+DPA-FFA and EPA-EE reduced least squares geometric mean triglycerides', 'pharmacodynamic responses and plasma omega-3 levels', 'docosahexaenoic acid', 'EPA+DPA-FFA increased docosahexaenoic acid', 'EPA+DPA-FFA increased least squares geometric mean plasma EPA, DPA, and total omega-3 (EPA+docosahexaenoic acid+DPA) concentrations', 'high-sensitivity C-reactive protein', 'triglyceride lowering and higher plasma EPA']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0236060', 'cui_str': 'Free fatty acids increased'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]",100.0,0.101895,EPA+DPA-FFA also reduced triglycerides and high-sensitivity C-reactive protein without increasing low-density lipoprotein cholesterol.,"[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research Addison IL.'}, {'ForeName': 'Harold E', 'Initials': 'HE', 'LastName': 'Bays', 'Affiliation': 'Louisville Metabolic and Atherosclerosis Research Center, Inc. Louisville KY.'}, {'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Ballantyne', 'Affiliation': 'Baylor College of Medicine New York NY.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Underberg', 'Affiliation': 'NYU School of Medicine and NYU Center for Prevention of Cardiovascular Disease New York NY.'}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': 'Department of Vascular Medicine University of Amsterdam the Netherlands.'}, {'ForeName': 'Judith B', 'Initials': 'JB', 'LastName': 'Johnson', 'Affiliation': 'Matinas BioPharma Inc. Bedminster NJ.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Ferguson', 'Affiliation': 'Matinas BioPharma Inc. Bedminster NJ.'}]",Journal of the American Heart Association,['10.1161/JAHA.121.024176']
3019,35232533,Picture Examination Communication System Versus Video Modelling in Improving Oral Hygiene of Children with Autism Spectrum Disorder: A Prospective Randomized Clinical Trial.,"Purpose:  The purpose of this study was to compare video modelling (VM) to a Picture Exchange Communication System (PECS) aimed at improving the oral hygiene of children with autism spectrum disorder (ASD).  Methods:  This prospectively stratified randomized controlled trial was conducted on 50 children with mild and moderate ASD. Children were assigned into two balanced groups. The control group was educated through PECS, and the intervention group was exposed to VM. Oral hygiene was assessed using the Oral Hygiene Index-simplified (OHI-s) on four occasions (at baseline and at three, six, and 12 months). Quantitative data were analyzed using Fisher's exact test and a t-test at a five percent significance level and 95 percent confidence interval (95% CI), respectively. Spearman's rank correlation coefficient (r) was used to correlate baseline characteristics in both groups to obtain average OHI-s scores.  Results:  The VM group showed a statistically significant reduction in average OHI-s scores compared to the PECS group over the follow-up period (P<0.001). At three, six, and 12 months, the OHI-s mean differences were 0.30 (95% CI equals 0.14 to 0.47), 0.58 (95% CI equals 0.39 to 0.77), and 0.57 (95% CI equals 0.30 to 0.84), respectively. For both groups, the severity of ASD was moderately associated with OHI-s scores at 12 months.  Conclusion:  Video modelling showed superior results in improving the oral hygiene of children with autism spectrum disorder compared to the Picture Exchange Communication System.",2022,The VM group showed a statistically significant reduction in average OHI-s scores compared to the PECS group over the follow-up period (P<0.001).,"['children with autism spectrum disorder', 'children with autism spectrum disorder (ASD', 'Children with Autism', 'Spectrum Disorder', '50 children with mild and moderate ASD']","['PECS', 'Picture Examination Communication System Versus Video Modelling', 'video modelling (VM) to a Picture Exchange Communication System (PECS']","['Oral hygiene', 'oral hygiene', 'average OHI-s scores', 'severity of ASD']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0055065', 'cui_str': 'CEP combination'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}]",50.0,0.141814,The VM group showed a statistically significant reduction in average OHI-s scores compared to the PECS group over the follow-up period (P<0.001).,"[{'ForeName': 'Mohamed Abdel Samad Ahmad', 'Initials': 'MASA', 'LastName': 'Shalabi', 'Affiliation': 'Dr. Shalabi is an administrator in Paediatric and Community Dentistry, Faculty of Dentistry, Aswan University, Tingar, Egypt.'}, {'ForeName': 'Nagwa Mohmmad Ali', 'Initials': 'NMA', 'LastName': 'Khattab', 'Affiliation': 'Dr. Khattab is a professor of Pediatric and Community Dentistry, Faculty of Dentistry, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmad Abdel Hamid', 'Initials': 'AAH', 'LastName': 'Elheeny', 'Affiliation': 'Dr. Elheeny is an associate professor of Pediatric and Community Dentistry, Faculty of Dentistry, Minia University, Minya, Egypt;, Email: ahmedelheeny@mu.edu.eg.'}]",Pediatric dentistry,[]
3020,35232509,Does psychological treatment of major depression reduce cardiac risk biomarkers? An exploratory randomized controlled trial.,"BACKGROUND


Depression is associated with an increased risk for cardiovascular disease (CVD). Biological cardiac risk factors are already elevated in depressed patients without existing CVD. The purpose of this exploratory trial was to examine whether treating Major Depression (MD) with cognitive behavioral therapy (CBT) is associated with improvements in cardiac risk biomarkers and whether depressive symptom severity at baseline moderates treatment effects.
METHODS


Eighty antidepressant-free patients with MD were randomly assigned to CBT or waiting list (WL). Biological outcomes included long-term recordings (24-h, daytime, nighttime) of heart rate, heart rate variability (HRV), and blood pressure, as well as inflammatory markers such as C-reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-α. A sample of 40 age- and sex-matched non-clinical controls was also involved to verify biological alterations in MD at study entry.
RESULTS


Compared to WL, CBT was associated with a significant increase in overall HRV, as indexed by the 24-h and daytime HRV triangular index, as well as trend improvements in 24-h low-frequency HRV and daytime systolic blood pressure. Self-rated depressive symptom severity moderated (or tended to moderate) improvements in CBT for 24-h and daytime heart rate and several indices of HRV (especially daytime measures). Inflammatory treatment effects were not observed.
CONCLUSIONS


CBT increased overall HRV in patients with MD. Initially more depressed patients showed the most pronounced cardiovascular improvements through CBT. These exploratory findings may provide new insights into the biological effects of psychological treatment against depression and must be confirmed through future research.",2022,Self-rated depressive symptom severity moderated (or tended to moderate) improvements in CBT for 24-h and daytime heart rate and several indices of HRV (especially daytime measures).,"['depressed patients without existing CVD', 'patients with MD', 'Eighty antidepressant-free patients with MD']","['cognitive behavioral therapy (CBT', 'CBT or waiting list (WL', 'CBT']","['24-h low-frequency HRV and daytime systolic blood pressure', 'overall HRV', 'Biological cardiac risk factors', 'CBT for 24-h and daytime heart rate and several indices of HRV', '24-h and daytime HRV triangular index', 'Biological outcomes included long-term recordings (24-h, daytime, nighttime) of heart rate, heart rate variability (HRV), and blood pressure, as well as inflammatory markers such as C-reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-α. A sample', 'cardiac risk biomarkers']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",80.0,0.115479,Self-rated depressive symptom severity moderated (or tended to moderate) improvements in CBT for 24-h and daytime heart rate and several indices of HRV (especially daytime measures).,"[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Euteneuer', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Medical School Berlin, Berlin, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Neuert', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, University of Marburg, Marburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Salzmann', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, University of Marburg, Marburg, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Fischer', 'Affiliation': 'Clinical Psychology and Psychotherapy, Institute of Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Ehlert', 'Affiliation': 'Clinical Psychology and Psychotherapy, Institute of Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, University of Marburg, Marburg, Germany.'}]",Psychological medicine,['10.1017/S0033291722000447']
3021,35232491,The comparative interrupted time series design for assessment of diagnostic impact: methodological considerations and an example using point-of-care C-reactive protein testing.,"BACKGROUND


In diagnostic evaluation, it is necessary to assess the clinical impact of a new diagnostic as well as its diagnostic accuracy. The comparative interrupted time series design has been proposed as a quasi-experimental approach to evaluating interventions. We show how it can be used in the design of a study to evaluate a point-of-care diagnostic test for C-reactive protein in out-of-hours primary care services, to guide antibiotic prescribing among patients presenting with possible respiratory tract infection. This study consisted of a retrospective phase that used routinely collected monthly antibiotic prescribing data from different study sites, and a prospective phase in which antibiotic prescribing rates were monitored after the C-reactive protein diagnostic was introduced at some of the sites.
METHODS


Of 8 study sites, 3 were assigned to receive the diagnostic and 5 were assigned as controls. We obtained retrospective monthly time series of respiratory tract targeted antibiotic prescriptions at each site. Separate ARIMA models at each site were used these to forecast monthly prescription counts that would be expected in the prospective phase, using simulation to obtain a set of 1-year predictions alongside their standard errors. We show how these forecasts can be combined to test for a change in prescription rates after introduction of the diagnostic and estimate power to detect this change.
RESULTS


Fitted time series models at each site were stationary and showed second-order annual seasonality, with a clear December peak in prescriptions, although the timing and extent of the peak varied between sites and between years. Mean one-year predictions of antibiotic prescribing rates based on the retrospective time series analysis differed between sites assigned to receive the diagnostic and those assigned to control. Adjusting for the trend in the retrospective time series at each site removed these differences.
CONCLUSIONS


Quasi-experimental designs such as comparative interrupted time series can be used in diagnostic evaluation to estimate effect sizes before conducting a full randomised controlled trial or if a randomised trial is infeasible. In multi-site studies, existing retrospective data should be used to adjust for underlying differences between sites to make outcome data from different sites comparable, when possible.",2022,"We show how these forecasts can be combined to test for a change in prescription rates after introduction of the diagnostic and estimate power to detect this change.
","['Of 8 study sites', 'patients presenting with possible respiratory tract infection']",[],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}]",[],[],,0.0309602,"We show how these forecasts can be combined to test for a change in prescription rates after introduction of the diagnostic and estimate power to detect this change.
","[{'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Fanshawe', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK. thomas.fanshawe@phc.ox.ac.uk.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Turner', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Marjorie M', 'Initials': 'MM', 'LastName': 'Gillespie', 'Affiliation': 'Practice Plus Group, Hawker House, 5-6 Napier Court, Napier Road, Reading, Berkshire, England, RG1 8BW, UK.'}, {'ForeName': 'Gail N', 'Initials': 'GN', 'LastName': 'Hayward', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}]",Diagnostic and prognostic research,['10.1186/s41512-022-00118-w']
3022,35232482,Multidisciplinary integrative care versus chiropractic care for low back pain: a randomized clinical trial.,"BACKGROUND


Low back pain (LBP) is influenced by interrelated biological, psychological, and social factors, however current back pain management is largely dominated by one-size fits all unimodal treatments. Team based models with multiple provider types from complementary professional disciplines is one way of integrating therapies to address patients' needs more comprehensively.
METHODS


This parallel group randomized clinical trial conducted from May 2007 to August 2010 aimed to evaluate the relative clinical effectiveness of 12 weeks of monodisciplinary chiropractic care (CC), versus multidisciplinary integrative care (IC), for adults with sub-acute and chronic LBP. The primary outcome was pain intensity and secondary outcomes were disability, improvement, medication use, quality of life, satisfaction, frequency of symptoms, missed work or reduced activities days, fear avoidance beliefs, self-efficacy, pain coping strategies and kinesiophobia measured at baseline and 4, 12, 26 and 52 weeks. Linear mixed models were used to analyze outcomes.
RESULTS


201 participants were enrolled. The largest reductions in pain intensity occurred at the end of treatment and were 43% for CC and 47% for IC. The primary analysis found IC to be significantly superior to CC over the 1-year period (P = 0.02). The long-term profile for pain intensity which included data from weeks 4 through 52, showed a significant advantage of 0.5 for IC over CC (95% CI 0.1 to 0.9; P = 0.02; 0 to 10 scale). The short-term profile (weeks 4 to 12) favored IC by 0.4, but was not statistically significant (95% CI - 0.02 to 0.9; P = 0.06). There was also a significant advantage over the long term for IC in some secondary measures (disability, improvement, satisfaction and low back symptom frequency), but not for others (medication use, quality of life, leg symptom frequency, fear avoidance beliefs, self-efficacy, active pain coping, and kinesiophobia). Importantly, no serious adverse events resulted from either of the interventions.
CONCLUSIONS


Participants in the IC group tended to have better outcomes than the CC group, however the magnitude of the group differences was relatively small. Given the resources required to successfully implement multidisciplinary integrative care teams, they may not be worthwhile, compared to monodisciplinary approaches like chiropractic care, for treating LBP. Trial registration NCT00567333.",2022,The largest reductions in pain intensity occurred at the end of treatment and were 43% for CC and 47% for IC.,"['adults with sub-acute and chronic LBP', 'low back pain', '201 participants were enrolled']","['Multidisciplinary integrative care versus chiropractic care', 'monodisciplinary chiropractic care (CC), versus multidisciplinary integrative care (IC']","['pain intensity', 'pain intensity and secondary outcomes were disability, improvement, medication use, quality of life, satisfaction, frequency of symptoms, missed work or reduced activities days, fear avoidance beliefs, self-efficacy, pain coping strategies and kinesiophobia', 'others (medication use, quality of life, leg symptom frequency, fear avoidance beliefs, self-efficacy, active pain coping, and kinesiophobia', 'satisfaction and low back symptom frequency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0436350', 'cui_str': 'Symptom frequency'}, {'cui': 'C1283330', 'cui_str': 'Absenteeism at work'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",201.0,0.227595,The largest reductions in pain intensity occurred at the end of treatment and were 43% for CC and 47% for IC.,"[{'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Bronfort', 'Affiliation': 'University of Minnesota, Mayo Building C504, 420 Delaware Street SE, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maiers', 'Affiliation': 'Northwestern Health Sciences University, 2501 W. 84th Street, Bloomington, MN, 55431, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Schulz', 'Affiliation': 'University of Minnesota, Mayo Building C504, 420 Delaware Street SE, Minneapolis, MN, 55455, USA. schu1385@umn.edu.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Leininger', 'Affiliation': 'University of Minnesota, Mayo Building C504, 420 Delaware Street SE, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Westrom', 'Affiliation': 'University of Minnesota, Mayo Building C504, 420 Delaware Street SE, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Angstman', 'Affiliation': ""St. Elizabeth's Medical Center-Wabasha, 1000 1st Dr NW, Austin, MN, USA.""}, {'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'University of Minnesota, Mayo Building C504, 420 Delaware Street SE, Minneapolis, MN, 55455, USA.'}]",Chiropractic & manual therapies,['10.1186/s12998-022-00419-3']
3023,35232475,"The effects of high-intensity functional training on cardiometabolic risk factors and exercise enjoyment in men and women with metabolic syndrome: study protocol for a randomized, 12-week, dose-response trial.","BACKGROUND


Individuals with metabolic syndrome (MetS) are at a greater risk for developing atherosclerotic cardiovascular disease (ASCVD) than those without MetS, due to underlying endothelial dysfunction, dyslipidemia, and insulin resistance. Exercise is an effective primary and secondary prevention strategy for MetS; however, less than 25% of adults meet the minimum stated public recommendations. Barriers often identified are lack of enjoyment and lack of time. High-intensity functional training (HIFT), a time-efficient modality of exercise, has shown some potential to elicit positive affectivity and elicit increased fitness and improved glucose metabolism. However, the effects of HIFT on dyslipidemia and endothelial dysfunction have not been explored nor have the effects been explored in a population with MetS. Additionally, no studies have investigated the minimal dose of HIFT per week to see clinically meaningful changes in cardiometabolic health. The purpose of this study is to (1) determine the dose-response effect of HIFT on blood lipids, insulin resistance, and endothelial function and (2) determine the dose-response effect of HIFT on body composition, fitness, and perceived enjoyment and intention to continue the exercise.
METHODS/DESIGN


In this randomized, dose-response trial, participants will undergo a 12-week HIFT intervention of either 1 day/week, 2 days/week, or 3 days/week of supervised, progressive exercise. Outcomes assessed at baseline and post-intervention will be multiple cardiometabolic markers, and fitness. Additionally, the participant's affective response will be measured after the intervention.
DISCUSSION


The findings of this research will provide evidence on the minimal dose of HIFT per week to see clinically meaningful improvements in the risk factors of MetS, as well as whether this modality is likely to mitigate the barriers to exercise. If an effective dose of HIFT per week is determined and if this modality is perceived positively, it may provide exercise specialists and health care providers a tool to prevent and treat MetS.
TRIAL REGISTRATION


ClinicalTrials.gov NCT05001126 . August 11, 2021.",2022,"BACKGROUND


Individuals with metabolic syndrome (MetS) are at a greater risk for developing atherosclerotic cardiovascular disease (ASCVD) than those without MetS, due to underlying endothelial dysfunction, dyslipidemia, and insulin resistance.","['population with MetS', 'men and women with metabolic syndrome', 'Individuals with metabolic syndrome (MetS']","['Exercise', 'High-intensity functional training (HIFT', 'high-intensity functional training', 'HIFT']","['cardiometabolic health', 'blood lipids, insulin resistance, and endothelial function', 'fitness and improved glucose metabolism', 'body composition, fitness, and perceived enjoyment and intention to continue the exercise', 'cardiometabolic risk factors and exercise enjoyment', 'multiple cardiometabolic markers, and fitness']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0301563,"BACKGROUND


Individuals with metabolic syndrome (MetS) are at a greater risk for developing atherosclerotic cardiovascular disease (ASCVD) than those without MetS, due to underlying endothelial dysfunction, dyslipidemia, and insulin resistance.","[{'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Smith', 'Affiliation': 'Department of Recreation, Exercise, and Sport Science, Western Colorado University, Gunnison, CO, USA. lesmith@western.edu.'}, {'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Van Guilder', 'Affiliation': 'Department of Recreation, Exercise, and Sport Science, Western Colorado University, Gunnison, CO, USA.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Dalleck', 'Affiliation': 'Department of Recreation, Exercise, and Sport Science, Western Colorado University, Gunnison, CO, USA.'}, {'ForeName': 'N K', 'Initials': 'NK', 'LastName': 'Harris', 'Affiliation': 'Health and Environmental Sciences Department, Auckland University of Technology, Auckland, New Zealand.'}]",Trials,['10.1186/s13063-022-06100-7']
3024,35232474,Effects of additional context information in prescription drug information sheets on comprehension and risk and efficacy perceptions.,"OBJECTIVE


To determine how additional explanatory text (context) about drug side effects in a patient medication information handout affected comprehension and perceptions of risk and efficacy.
METHODS


We conducted an online experiment with a national sample of 1,119 U.S. adults with rheumatoid arthritis and related conditions, sampled through random-digit dialing, address-based sampling, and online ads. We randomized participants to receive one of several versions of a patient information handout for a fictitious drug, either with or without additional context, then measured comprehension and other outcomes.
RESULTS


Additional qualitative context about warnings and side effects resulted in lower comprehension of side effect information, but not information about uses of the drug or warnings. The effect of additional context on risk perceptions depended on whether the medication handout was delivered online or through the mail. Those who received a hardcopy of the handout with additional context had higher perceived risk of side effects than those who saw the version without additional context.
CONCLUSION


More clarifying information is not always better and may lead to cognitive overload, inhibiting comprehension.
PRACTICE IMPLICATIONS


Additional research should further explore effects of context in online vs. hard-copy formats before practice implications can be determined.",2022,"RESULTS


Additional qualitative context about warnings and side effects resulted in lower comprehension of side effect information, but not information about uses of the drug or warnings.","['1,119 U.S. adults with rheumatoid arthritis and related conditions, sampled through random-digit dialing, address-based sampling, and online ads']",[],"['risk perceptions', 'comprehension and risk and efficacy perceptions', 'risk of side effects']","[{'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",1119.0,0.110871,"RESULTS


Additional qualitative context about warnings and side effects resulted in lower comprehension of side effect information, but not information about uses of the drug or warnings.","[{'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Kelly', 'Affiliation': 'RTI International, 701 13th Street NW, Ste. 750, Washington, DC, 20005, USA. bkelly@rti.org.'}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': ""O'Donoghue"", 'Affiliation': 'Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Parvanta', 'Affiliation': 'RTI International, 701 13th Street NW, Ste. 750, Washington, DC, 20005, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Boudewyns', 'Affiliation': 'RTI International, 701 13th Street NW, Ste. 750, Washington, DC, 20005, USA.'}, {'ForeName': 'Oluwamurewa', 'Initials': 'O', 'LastName': 'Oguntimein', 'Affiliation': 'Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Bann', 'Affiliation': 'RTI International, 701 13th Street NW, Ste. 750, Washington, DC, 20005, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'West', 'Affiliation': 'RTI International, 701 13th Street NW, Ste. 750, Washington, DC, 20005, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Tzeng', 'Affiliation': 'RTI International, 701 13th Street NW, Ste. 750, Washington, DC, 20005, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Chandler', 'Affiliation': 'RTI International, 701 13th Street NW, Ste. 750, Washington, DC, 20005, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Madson', 'Affiliation': 'RTI International, 701 13th Street NW, Ste. 750, Washington, DC, 20005, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'McCormack', 'Affiliation': 'RTI International, 701 13th Street NW, Ste. 750, Washington, DC, 20005, USA.'}]",Journal of pharmaceutical policy and practice,['10.1186/s40545-021-00386-9']
3025,35232389,Feasibility of an online training and support program for dementia carers: results from a mixed-methods pilot randomized controlled trial.,"BACKGROUND


iSupport is an online program developed by the World Health Organization to provide education, skills training, and social support to informal carers of persons with dementia. This pilot study examines the feasibility of the protocol for a main effectiveness trial of iSupport-Portugal and explores how the intervention and control arms compare over time on well-being outcomes.
METHODS


A mixed-methods experimental parallel between-group design with two arms is followed. Participants were recruited nationwide, by referral or advertising, through the National Alzheimer's Association. Inclusion criteria are being Portuguese adults, providing e-consent, providing unpaid care to someone with dementia for at least 6 months, experiencing relevant scores on burden (≥ 21 on ZBI) or depression or anxiety (≥ 8 on HADS), and using webpages autonomously. Participants were consecutively randomized to receive iSupport-Portugal or an education-only e-book and were not blinded to group assignment. Data were collected online with self-administered instruments, at baseline, 3 and 6 months after. Outcomes comprise caregiver burden, depression, anxiety, QoL, positive aspects of caregiving, and self-efficacy. Generalized estimating equations were used to estimate group, time, and group-by-time effects. Intervention engagement data were extracted from iSupport's platform. Semi-structured interviews were conducted.
RESULTS


Forty-two participants were allocated to the intervention (N = 21) and control (N = 21) arms. Participation (78.1%) and retention rates (73.8%) were fair. More carers in the control arm completed the study (N = 20, 95.2%) than in the intervention arm (N = 11; 52.4%) (χ 2  = 9.98, p = .002). Non-completers were younger, spent less time caring, and scored higher on anxiety. Among carers in the intervention arm, the average attendance rate was of 53.7%. At post-test 38.9% of participants still used iSupport; the remainder participants interrupted use within 2 weeks (Mdn). For per-protocol analyses, significant group-by-time interaction effects favouring the intervention were found for anxiety (Wald χ2 = 6.17, p = .046) and for environmental QoL (Wald χ 2  = 7.06, p = .029). Those effects were not observed in intention-to-treat analyses adjusted for age. Interviewees from the intervention arm (N = 12) reported positive results of iSupport on knowledge and on experiencing positive feelings. No adverse effects were reported.
CONCLUSIONS


This study provides information for a forthcoming full-scale effectiveness trial, as on the acceptability and potential results of iSupport-Portugal. iSupport is suggested as a relevant resource for Portuguese carers.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04104568 . 26/09/2019.",2022,"More carers in the control arm completed the study (N = 20, 95.2%) than in the intervention arm (N = 11; 52.4%)","[""Participants were recruited nationwide, by referral or advertising, through the National Alzheimer's Association"", 'Forty-two participants', 'Inclusion criteria are being Portuguese adults, providing e-consent, providing unpaid care to someone with dementia for at least 6\u2009months, experiencing relevant scores on burden (≥ 21 on ZBI) or depression or anxiety (≥ 8 on HADS), and using webpages autonomously', 'dementia carers']","['iSupport-Portugal or an education-only e-book', 'online training and support program']","['average attendance rate', 'retention rates', 'anxiety', 'caregiver burden, depression, anxiety, QoL, positive aspects of caregiving, and self-efficacy', 'adverse effects', 'environmental QoL']","[{'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032730', 'cui_str': 'Portuguese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",42.0,0.142448,"More carers in the control arm completed the study (N = 20, 95.2%) than in the intervention arm (N = 11; 52.4%)","[{'ForeName': 'Soraia', 'Initials': 'S', 'LastName': 'Teles', 'Affiliation': 'Faculty of Medicine, University of Porto (FMUP), Alameda Prof. Hernâni Monteiro, 4200-319, Porto, Portugal. teles.s.soraia@gmail.com.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Medicine, University of Porto (FMUP), Alameda Prof. Hernâni Monteiro, 4200-319, Porto, Portugal.'}, {'ForeName': 'Constança', 'Initials': 'C', 'LastName': 'Paúl', 'Affiliation': 'Center for Health Technology and Services Research (CINTESIS), Rua Dr. Plácido da Costa, 4200-450, Porto, Portugal.'}]",BMC geriatrics,['10.1186/s12877-022-02831-z']
3026,35232809,Impact of Tofacitinib on Components of the ACR Response Criteria: Posthoc Analysis of Phase III and Phase IIIb/IV Trials.,"OBJECTIVE


Evaluate the impact of tofacitinib on American College of Rheumatology (ACR) response criteria components in patients with rheumatoid arthritis (RA).
METHODS


This posthoc analysis pooled data from RA phase III randomized controlled trials (RCTs) assessing tofacitinib 5 or 10 mg twice daily (BID), adalimumab, or placebo, with conventional synthetic disease-modifying antirheumatic drugs, and a phase IIIb/IV RCT assessing tofacitinib 5 mg BID monotherapy, tofacitinib 5 mg BID with methotrexate, or adalimumab with methotrexate. Outcomes included: proportions of patients achieving ACR20/50/70 responses and ≥20/50/70% improvement rates in ACR components at Week 2 and Months 1, 3, and 6; mean percent improvement in ACR components and Clinical or Simplified Disease Activity Index (CDAI or SDAI) low disease activity or remission rates, at Month 3, for ACR20/50/70 responders.
RESULTS


Across treatment groups, ≥20/50/70% improvement rates were numerically higher for most physician- versus patient-reported measures. In phase III RCTs, at earlier timepoints, ≥50/70% improvements in Patient Global Assessment of Disease Activity, Pain and Clinician Global Assessment were similar. Among ACR20 responders receiving tofacitinib, mean percent improvements for tender and swollen joint counts were >70% at Month 3. CDAI/SDAI remission was achieved by 27.8-45.0% of ACR70 responders receiving tofacitinib at Month 3.
CONCLUSION


Among ACR20 responders treated with tofacitinib, physician-reported components particularly exceeded 20% response improvement. At Month 3, disease state generally did not corroborate ACR70 response criteria. Divergences between physician- and patient-reported measures highlight the importance of identifying appropriate patient-reported outcome targets to manage RA symptoms in clinical practice.",2022,"Among ACR20 responders receiving tofacitinib, mean percent improvements for tender and swollen joint counts were >70% at Month 3.","['patients with rheumatoid arthritis (RA', 'American College of Rheumatology (ACR']","['adalimumab, or placebo', 'RCT assessing tofacitinib 5 mg BID monotherapy, tofacitinib 5 mg BID with methotrexate, or adalimumab with methotrexate', 'tofacitinib', 'Tofacitinib']","['tender and swollen joint counts', 'ACR components and Clinical or Simplified Disease Activity Index (CDAI or SDAI) low disease activity or remission rates', 'Patient Global Assessment of Disease Activity, Pain and Clinician Global Assessment', 'CDAI/SDAI remission', 'proportions of patients achieving ACR20/50/70 responses and ≥20/50/70% improvement rates in ACR components']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3505040', 'cui_str': 'tofacitinib 5 MG'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}]","[{'cui': 'C0234234', 'cui_str': 'Tender'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.338713,"Among ACR20 responders receiving tofacitinib, mean percent improvements for tender and swollen joint counts were >70% at Month 3.","[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bessette', 'Affiliation': ""Funding: This study was sponsored by Pfizer Inc. Medical writing support, under the guidance of the authors, was provided by Jennifer Arnold, PhD, CMC Connect, McCann Health Medical Communications and was funded by Pfizer Inc, New York, NY, USA in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461-464). L. Bessette, MD, MSc, Associate Professor, Department of Medicine, Laval University, Quebec, Quebec, Canada; E. Mysler, MD, Director, Organización Médica de Investigación, Buenos Aires, Argentina; C.D. Kinch, PhD, Medical Advisor, P.V. On, MSc, Senior Manager Access, Pfizer Canada ULC, Kirkland, Quebec, Canada; K. Kwok, MS, Senior Director, T. Lukic, MD, MSc, Global Clinical Lead, Pfizer Inc, New York, New York, USA;5R.F. van Vollenhoven, MD, PhD, Director, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands; R.F. van Vollenhoven, MD, PhD, Professor and Chair, Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centres, Amsterdam, The Netherlands. Conflict of Interest: LB has received grants and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Gilead Sciences, Novartis, Pfizer Inc, Roche, Sanofi, and UCB; and has acted as a consultant or speaker for AbbVie, Celgene, Eli Lilly, Fresenius Kabi, Gilead Sciences, Novartis, Pfizer Inc, and Sandoz. EM has received research grants from Eli Lilly, Pfizer Inc, and Roche; and serves on speakers' bureaus for AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, Roche, and Sanofi. CDK, KK, TL, and PVO are employees and stockholders of Pfizer Inc. RFvV has received grants and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, GSK, Pfizer Inc, Roche, and UCB; and has acted as a consultant for AbbVie, AstraZeneca, Biotest, Bristol- Myers Squibb, Celgene, Crescendo, Eli Lilly, GSK, Janssen, Merck, Novartis, Pfizer Inc, Roche, UCB, and Vertex. Address correspondence to C. D Kinch, Pfizer Canada ULC, 17300 Trans-Canada Hwy, Kirkland, QC, Canada H9J2M5. Telephone: 403-827-3347. Email: Cassandra.Kinch@pfizer.com.""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Mysler', 'Affiliation': ""Funding: This study was sponsored by Pfizer Inc. Medical writing support, under the guidance of the authors, was provided by Jennifer Arnold, PhD, CMC Connect, McCann Health Medical Communications and was funded by Pfizer Inc, New York, NY, USA in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461-464). L. Bessette, MD, MSc, Associate Professor, Department of Medicine, Laval University, Quebec, Quebec, Canada; E. Mysler, MD, Director, Organización Médica de Investigación, Buenos Aires, Argentina; C.D. Kinch, PhD, Medical Advisor, P.V. On, MSc, Senior Manager Access, Pfizer Canada ULC, Kirkland, Quebec, Canada; K. Kwok, MS, Senior Director, T. Lukic, MD, MSc, Global Clinical Lead, Pfizer Inc, New York, New York, USA;5R.F. van Vollenhoven, MD, PhD, Director, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands; R.F. van Vollenhoven, MD, PhD, Professor and Chair, Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centres, Amsterdam, The Netherlands. Conflict of Interest: LB has received grants and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Gilead Sciences, Novartis, Pfizer Inc, Roche, Sanofi, and UCB; and has acted as a consultant or speaker for AbbVie, Celgene, Eli Lilly, Fresenius Kabi, Gilead Sciences, Novartis, Pfizer Inc, and Sandoz. EM has received research grants from Eli Lilly, Pfizer Inc, and Roche; and serves on speakers' bureaus for AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, Roche, and Sanofi. CDK, KK, TL, and PVO are employees and stockholders of Pfizer Inc. RFvV has received grants and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, GSK, Pfizer Inc, Roche, and UCB; and has acted as a consultant for AbbVie, AstraZeneca, Biotest, Bristol- Myers Squibb, Celgene, Crescendo, Eli Lilly, GSK, Janssen, Merck, Novartis, Pfizer Inc, Roche, UCB, and Vertex. Address correspondence to C. D Kinch, Pfizer Canada ULC, 17300 Trans-Canada Hwy, Kirkland, QC, Canada H9J2M5. Telephone: 403-827-3347. Email: Cassandra.Kinch@pfizer.com.""}, {'ForeName': 'Cassandra D', 'Initials': 'CD', 'LastName': 'Kinch', 'Affiliation': ""Funding: This study was sponsored by Pfizer Inc. Medical writing support, under the guidance of the authors, was provided by Jennifer Arnold, PhD, CMC Connect, McCann Health Medical Communications and was funded by Pfizer Inc, New York, NY, USA in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461-464). L. Bessette, MD, MSc, Associate Professor, Department of Medicine, Laval University, Quebec, Quebec, Canada; E. Mysler, MD, Director, Organización Médica de Investigación, Buenos Aires, Argentina; C.D. Kinch, PhD, Medical Advisor, P.V. On, MSc, Senior Manager Access, Pfizer Canada ULC, Kirkland, Quebec, Canada; K. Kwok, MS, Senior Director, T. Lukic, MD, MSc, Global Clinical Lead, Pfizer Inc, New York, New York, USA;5R.F. van Vollenhoven, MD, PhD, Director, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands; R.F. van Vollenhoven, MD, PhD, Professor and Chair, Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centres, Amsterdam, The Netherlands. Conflict of Interest: LB has received grants and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Gilead Sciences, Novartis, Pfizer Inc, Roche, Sanofi, and UCB; and has acted as a consultant or speaker for AbbVie, Celgene, Eli Lilly, Fresenius Kabi, Gilead Sciences, Novartis, Pfizer Inc, and Sandoz. EM has received research grants from Eli Lilly, Pfizer Inc, and Roche; and serves on speakers' bureaus for AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, Roche, and Sanofi. CDK, KK, TL, and PVO are employees and stockholders of Pfizer Inc. RFvV has received grants and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, GSK, Pfizer Inc, Roche, and UCB; and has acted as a consultant for AbbVie, AstraZeneca, Biotest, Bristol- Myers Squibb, Celgene, Crescendo, Eli Lilly, GSK, Janssen, Merck, Novartis, Pfizer Inc, Roche, UCB, and Vertex. Address correspondence to C. D Kinch, Pfizer Canada ULC, 17300 Trans-Canada Hwy, Kirkland, QC, Canada H9J2M5. Telephone: 403-827-3347. Email: Cassandra.Kinch@pfizer.com.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kwok', 'Affiliation': ""Funding: This study was sponsored by Pfizer Inc. Medical writing support, under the guidance of the authors, was provided by Jennifer Arnold, PhD, CMC Connect, McCann Health Medical Communications and was funded by Pfizer Inc, New York, NY, USA in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461-464). L. Bessette, MD, MSc, Associate Professor, Department of Medicine, Laval University, Quebec, Quebec, Canada; E. Mysler, MD, Director, Organización Médica de Investigación, Buenos Aires, Argentina; C.D. Kinch, PhD, Medical Advisor, P.V. On, MSc, Senior Manager Access, Pfizer Canada ULC, Kirkland, Quebec, Canada; K. Kwok, MS, Senior Director, T. Lukic, MD, MSc, Global Clinical Lead, Pfizer Inc, New York, New York, USA;5R.F. van Vollenhoven, MD, PhD, Director, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands; R.F. van Vollenhoven, MD, PhD, Professor and Chair, Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centres, Amsterdam, The Netherlands. Conflict of Interest: LB has received grants and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Gilead Sciences, Novartis, Pfizer Inc, Roche, Sanofi, and UCB; and has acted as a consultant or speaker for AbbVie, Celgene, Eli Lilly, Fresenius Kabi, Gilead Sciences, Novartis, Pfizer Inc, and Sandoz. EM has received research grants from Eli Lilly, Pfizer Inc, and Roche; and serves on speakers' bureaus for AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, Roche, and Sanofi. CDK, KK, TL, and PVO are employees and stockholders of Pfizer Inc. RFvV has received grants and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, GSK, Pfizer Inc, Roche, and UCB; and has acted as a consultant for AbbVie, AstraZeneca, Biotest, Bristol- Myers Squibb, Celgene, Crescendo, Eli Lilly, GSK, Janssen, Merck, Novartis, Pfizer Inc, Roche, UCB, and Vertex. Address correspondence to C. D Kinch, Pfizer Canada ULC, 17300 Trans-Canada Hwy, Kirkland, QC, Canada H9J2M5. Telephone: 403-827-3347. Email: Cassandra.Kinch@pfizer.com.""}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Lukic', 'Affiliation': ""Funding: This study was sponsored by Pfizer Inc. Medical writing support, under the guidance of the authors, was provided by Jennifer Arnold, PhD, CMC Connect, McCann Health Medical Communications and was funded by Pfizer Inc, New York, NY, USA in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461-464). L. Bessette, MD, MSc, Associate Professor, Department of Medicine, Laval University, Quebec, Quebec, Canada; E. Mysler, MD, Director, Organización Médica de Investigación, Buenos Aires, Argentina; C.D. Kinch, PhD, Medical Advisor, P.V. On, MSc, Senior Manager Access, Pfizer Canada ULC, Kirkland, Quebec, Canada; K. Kwok, MS, Senior Director, T. Lukic, MD, MSc, Global Clinical Lead, Pfizer Inc, New York, New York, USA;5R.F. van Vollenhoven, MD, PhD, Director, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands; R.F. van Vollenhoven, MD, PhD, Professor and Chair, Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centres, Amsterdam, The Netherlands. Conflict of Interest: LB has received grants and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Gilead Sciences, Novartis, Pfizer Inc, Roche, Sanofi, and UCB; and has acted as a consultant or speaker for AbbVie, Celgene, Eli Lilly, Fresenius Kabi, Gilead Sciences, Novartis, Pfizer Inc, and Sandoz. EM has received research grants from Eli Lilly, Pfizer Inc, and Roche; and serves on speakers' bureaus for AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, Roche, and Sanofi. CDK, KK, TL, and PVO are employees and stockholders of Pfizer Inc. RFvV has received grants and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, GSK, Pfizer Inc, Roche, and UCB; and has acted as a consultant for AbbVie, AstraZeneca, Biotest, Bristol- Myers Squibb, Celgene, Crescendo, Eli Lilly, GSK, Janssen, Merck, Novartis, Pfizer Inc, Roche, UCB, and Vertex. Address correspondence to C. D Kinch, Pfizer Canada ULC, 17300 Trans-Canada Hwy, Kirkland, QC, Canada H9J2M5. Telephone: 403-827-3347. Email: Cassandra.Kinch@pfizer.com.""}, {'ForeName': 'Phu Vinh', 'Initials': 'PV', 'LastName': 'On', 'Affiliation': ""Funding: This study was sponsored by Pfizer Inc. Medical writing support, under the guidance of the authors, was provided by Jennifer Arnold, PhD, CMC Connect, McCann Health Medical Communications and was funded by Pfizer Inc, New York, NY, USA in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461-464). L. Bessette, MD, MSc, Associate Professor, Department of Medicine, Laval University, Quebec, Quebec, Canada; E. Mysler, MD, Director, Organización Médica de Investigación, Buenos Aires, Argentina; C.D. Kinch, PhD, Medical Advisor, P.V. On, MSc, Senior Manager Access, Pfizer Canada ULC, Kirkland, Quebec, Canada; K. Kwok, MS, Senior Director, T. Lukic, MD, MSc, Global Clinical Lead, Pfizer Inc, New York, New York, USA;5R.F. van Vollenhoven, MD, PhD, Director, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands; R.F. van Vollenhoven, MD, PhD, Professor and Chair, Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centres, Amsterdam, The Netherlands. Conflict of Interest: LB has received grants and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Gilead Sciences, Novartis, Pfizer Inc, Roche, Sanofi, and UCB; and has acted as a consultant or speaker for AbbVie, Celgene, Eli Lilly, Fresenius Kabi, Gilead Sciences, Novartis, Pfizer Inc, and Sandoz. EM has received research grants from Eli Lilly, Pfizer Inc, and Roche; and serves on speakers' bureaus for AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, Roche, and Sanofi. CDK, KK, TL, and PVO are employees and stockholders of Pfizer Inc. RFvV has received grants and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, GSK, Pfizer Inc, Roche, and UCB; and has acted as a consultant for AbbVie, AstraZeneca, Biotest, Bristol- Myers Squibb, Celgene, Crescendo, Eli Lilly, GSK, Janssen, Merck, Novartis, Pfizer Inc, Roche, UCB, and Vertex. Address correspondence to C. D Kinch, Pfizer Canada ULC, 17300 Trans-Canada Hwy, Kirkland, QC, Canada H9J2M5. Telephone: 403-827-3347. Email: Cassandra.Kinch@pfizer.com.""}, {'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'van Vollenhoven', 'Affiliation': ""Funding: This study was sponsored by Pfizer Inc. Medical writing support, under the guidance of the authors, was provided by Jennifer Arnold, PhD, CMC Connect, McCann Health Medical Communications and was funded by Pfizer Inc, New York, NY, USA in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461-464). L. Bessette, MD, MSc, Associate Professor, Department of Medicine, Laval University, Quebec, Quebec, Canada; E. Mysler, MD, Director, Organización Médica de Investigación, Buenos Aires, Argentina; C.D. Kinch, PhD, Medical Advisor, P.V. On, MSc, Senior Manager Access, Pfizer Canada ULC, Kirkland, Quebec, Canada; K. Kwok, MS, Senior Director, T. Lukic, MD, MSc, Global Clinical Lead, Pfizer Inc, New York, New York, USA;5R.F. van Vollenhoven, MD, PhD, Director, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands; R.F. van Vollenhoven, MD, PhD, Professor and Chair, Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centres, Amsterdam, The Netherlands. Conflict of Interest: LB has received grants and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Gilead Sciences, Novartis, Pfizer Inc, Roche, Sanofi, and UCB; and has acted as a consultant or speaker for AbbVie, Celgene, Eli Lilly, Fresenius Kabi, Gilead Sciences, Novartis, Pfizer Inc, and Sandoz. EM has received research grants from Eli Lilly, Pfizer Inc, and Roche; and serves on speakers' bureaus for AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, Roche, and Sanofi. CDK, KK, TL, and PVO are employees and stockholders of Pfizer Inc. RFvV has received grants and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, GSK, Pfizer Inc, Roche, and UCB; and has acted as a consultant for AbbVie, AstraZeneca, Biotest, Bristol- Myers Squibb, Celgene, Crescendo, Eli Lilly, GSK, Janssen, Merck, Novartis, Pfizer Inc, Roche, UCB, and Vertex. Address correspondence to C. D Kinch, Pfizer Canada ULC, 17300 Trans-Canada Hwy, Kirkland, QC, Canada H9J2M5. Telephone: 403-827-3347. Email: Cassandra.Kinch@pfizer.com.""}]",The Journal of rheumatology,['10.3899/jrheum.210707']
3027,35232793,Evaluating US smokers' willingness to pay for different cigarette packaging designs before and after real-world exposure in a randomised trial.,"INTRODUCTION


Removal of tobacco industry branding from cigarette packs may reduce their appeal. Adding graphic warning labels (GWLs) should enhance this effect. We investigate whether willingness to pay for various packaging designs changes after 3 months' use of: (1) US branded packs without GWLs (US), (2) non-branded packs without GWLs (Blank), and (3) rotating non-branded packs with GWLs (gangrene; throat cancer; neonatal baby) covering >75% of pack (GWL).
METHODS


Californian adult daily smokers not planning to quit (n=287; 56% female; mean age=39.6) completed a discrete choice purchase task before and after 3 months' experience using one of three packaging options. Conjoint analysis and pre-post modelling evaluated the change in importance of pack attributes and willingness to pay for US, Blank or GWL (blindness; teeth; gangrene) pack designs.
RESULTS


Price determined ~70% of purchase choices, while pack design determined ~22%. Irrespective of intervention arm, US packaging generated appeal valuations compared with Blank packaging, while GWLs consistently provoked strong aversive valuations at baseline and follow-up. Compared with the US pack arm, using GWL packs for 3 months decreased willingness to pay for US packaging (β=-$0.38, 95% CI -0.76 to 0.00). Wear-out effects were detected in the discount needed to willingly purchase the gangrene-GWL pack (β=$0.49, 95% CI 0.16 to 0.82) and Blank pack (β=$0.42, 95% CI 0.09 to 0.74) but not for GWLs (blindness, teeth) not used in trial.
CONCLUSION


Compared with US branded packs, the negative valuation of non-branded GWL packs attenuates with even 3 months' use but does not generalise to non-used GWLs. This suggests that GWLs should be regularly refreshed. The appeal valuation of industry imagery suggests that the US plan to retain such imagery on packs may ameliorate the effect of GWLs.",2022,"Irrespective of intervention arm, US packaging generated appeal valuations compared with Blank packaging, while GWLs consistently provoked strong aversive valuations at baseline and follow-up.","[""Californian adult daily smokers not planning to quit (n=287; 56% female; mean age=39.6) completed a discrete choice purchase task before and after 3 months' experience using one of three packaging options""]","[' (1) US branded packs without GWLs (US), (2) non-branded packs without GWLs (Blank), and (3) rotating non-branded packs with GWLs (gangrene; throat cancer; neonatal baby) covering >75% of pack (GWL', 'graphic warning labels (GWLs']","['Blank pack', 'willingness to pay for US packaging']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0017086', 'cui_str': 'Gangrene'}, {'cui': 'C0740339', 'cui_str': 'Throat cancer'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439844', 'cui_str': 'Covered'}]","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]",,0.0808239,"Irrespective of intervention arm, US packaging generated appeal valuations compared with Blank packaging, while GWLs consistently provoked strong aversive valuations at baseline and follow-up.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Stone', 'Affiliation': 'Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA matthew.stone1@pennmedicine.upenn.edu.'}, {'ForeName': 'Claudiu', 'Initials': 'C', 'LastName': 'Dimofte', 'Affiliation': 'Marketing, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Strong', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Pulvers', 'Affiliation': 'Psychology, California State University San Marcos, San Marcos, California, USA.'}, {'ForeName': 'Noe C', 'Initials': 'NC', 'LastName': 'Crespo', 'Affiliation': 'School of Public Health, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Leas', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Pierce', 'Affiliation': 'Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, La Jolla, California, USA.'}]",Tobacco control,['10.1136/tobaccocontrol-2021-057071']
3028,35232782,Predictors of mortality in acute ischemic stroke treated with endovascular thrombectomy despite successful reperfusion: subgroup analysis of a multicentre randomised clinical trial.,"OBJECTIVES


We sought to determine the predictors of 90-day mortality despite successful reperfusion.
DESIGN


Subgroup analysis of a multicentre randomised clinical trial (ClinicalTrials.gov Identifier: NCT03469206).
SETTING


This study used data from the Direct Intra-arterial thrombectomy in order to Revascularize AIS patients with large vessel occlusion Efficiently in Chinese Tertiary hospitals: a Multicenter randomized clinical Trial (DIRECT-MT).
PARTICIPANTS


622 patients enrolled in DIRECT-MT.
RESULTS


Overall successful reperfusion rate was 82.0% (510/622), and 18.5% (115/622) of patients died within 90 days. Univariate analysis identified increased risks of mortality for age ≥70 years, history of diabetes mellitus, National Institutes of Health Stroke Scale (NIHSS) score on admission ≥17, NIHSS score after thrombectomy (24±6 hours) ≥11, Alberta Stroke Program Early Computed Tomography Score (ASPECTS) <9, glucose level at hospital arrival ≥130 mg/dL, location of internal carotid artery occlusion, embolisation into a new territory, symptomatic intracranial haemorrhage (ICH) and a decreased risk of mortality for smoking. In multivariable analysis, smoking (OR 0.38; 95% CI 0.17 to 0.83; p=0.015), NIHSS score on admission ≥17 (OR 3.14; 95% CI 1.77 to 5.55; p<0.001), glucose level at hospital arrival ≥130 mg/dL (OR 2.54; 95% CI 1.51 to 4.27; p<0.001), symptomatic ICH (OR 11.70; 95% CI 4.74 to 28.89; p<0.001) and NIHSS score after thrombectomy (24±6 hours) ≥11 (OR 12.04; 95% CI 5.09 to 28.46; p<0.001) were significant independent predictors of 90-day mortality.
CONCLUSIONS


Symptomatic ICH and high post-thrombectomy NIHSS score are strong predictor of 90-day mortality in acute ischaemic stroke treated with mechanical thrombectomy despite successful reperfusion, as well as high NIHSS score and high glucose level at hospital arrival. However, further studies need to be performed to confirm the association between smoking and mortality.",2022,"In multivariable analysis, smoking (OR 0.38; 95% CI 0.17 to 0.83; p=0.015), NIHSS score on admission ≥17 (OR 3.14; 95% CI 1.77 to 5.55; p<0.001), glucose level at hospital arrival ≥130 mg/dL (OR 2.54; 95% CI 1.51 to 4.27; p<0.001), symptomatic ICH (OR 11.70; 95% CI 4.74 to 28.89; p<0.001) and NIHSS score after thrombectomy (24±6 hours) ≥11 (OR 12.04; 95% CI 5.09 to 28.46; p<0.001) were significant independent predictors of 90-day mortality.
","['Revascularize AIS patients with large vessel occlusion Efficiently in Chinese Tertiary hospitals', '622 patients enrolled in DIRECT-MT', 'after thrombectomy (24±6 hours) ≥11, Alberta Stroke Program']",['endovascular thrombectomy despite successful reperfusion'],"['glucose level', 'glucose level at hospital arrival ≥130 mg/dL, location of internal carotid artery occlusion, embolisation into a new territory, symptomatic intracranial haemorrhage (ICH', 'NIHSS score', 'Overall successful reperfusion rate', 'symptomatic ICH', '90-day mortality', 'risk of mortality for smoking', 'risks of mortality for age ≥70 years, history of diabetes mellitus, National Institutes of Health Stroke Scale (NIHSS) score on admission ≥17, NIHSS score']","[{'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0149853', 'cui_str': 'Occlusion of internal carotid artery'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0524613', 'cui_str': 'New Territories'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0455488', 'cui_str': 'H/O: diabetes mellitus'}, {'cui': 'C0457453', 'cui_str': 'On admission'}]",622.0,0.359616,"In multivariable analysis, smoking (OR 0.38; 95% CI 0.17 to 0.83; p=0.015), NIHSS score on admission ≥17 (OR 3.14; 95% CI 1.77 to 5.55; p<0.001), glucose level at hospital arrival ≥130 mg/dL (OR 2.54; 95% CI 1.51 to 4.27; p<0.001), symptomatic ICH (OR 11.70; 95% CI 4.74 to 28.89; p<0.001) and NIHSS score after thrombectomy (24±6 hours) ≥11 (OR 12.04; 95% CI 5.09 to 28.46; p<0.001) were significant independent predictors of 90-day mortality.
","[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Maoming People's Hospital, Maoming, China.""}, {'ForeName': 'Jinbo', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ""Department of Neurology, Maoming People's Hospital, Maoming, China.""}, {'ForeName': 'Shisheng', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': ""Department of Neurology, Maoming People's Hospital, Maoming, China.""}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Neurology, Maoming People's Hospital, Maoming, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': ""Department of Neurology, Maoming People's Hospital, Maoming, China.""}, {'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Liao', 'Affiliation': ""Department of Neurology, Maoming People's Hospital, Maoming, China.""}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': ""Department of Neurology, Maoming People's Hospital, Maoming, China.""}, {'ForeName': 'Chaomao', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Maoming People's Hospital, Maoming, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': ""Department of Neurology, Maoming People's Hospital, Maoming, China.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, Naval Medical University Changhai hospital, Shanghai, China.'}, {'ForeName': 'Yongwei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Naval Medical University Changhai hospital, Shanghai, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Xing', 'Affiliation': 'Department of Neurology, Naval Medical University Changhai hospital, Shanghai, China.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, Naval Medical University Changhai hospital, Shanghai, China.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Department of Statistics, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': ""Department of Neurosurgery, Changzhou No. 1 People's Hospital, Changzhou, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': ""Department of Neurosurgery, Changzhou First People's Hospital, Changzhou, China mmyangz@163.com 13346256936@163.com mayday509@163.com.""}, {'ForeName': 'Liyong', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurosurgery, Liaocheng People's Hospital, Liaocheng City, Shandong, China mmyangz@163.com 13346256936@163.com mayday509@163.com.""}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Maoming People's Hospital, Maoming, China mmyangz@163.com 13346256936@163.com mayday509@163.com.""}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Naval Medical University Changhai hospital, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2021-053765']
3029,35237197,Mindfulness-Based Cognitive Therapy Regulates Brain Connectivity in Patients With Late-Life Depression.,"Late-life depression (LLD) is an important public health problem among the aging population. Recent studies found that mindfulness-based cognitive therapy (MBCT) can effectively alleviate depressive symptoms in major depressive disorder. The present study explored the clinical effect and potential neuroimaging mechanism of MBCT in the treatment of LLD. We enrolled 60 participants with LLD in an 8-week, randomized, controlled trial (ChiCTR1800017725). Patients were randomized to the treatment-as-usual (TAU) group or a MBCT+TAU group. The Hamilton Depression Scale (HAMD) and Hamilton Anxiety Scale (HAMA) were used to evaluate symptoms. Magnetic resonance imaging (MRI) was used to measure changes in resting-state functional connectivity and structural connectivity. We also measured the relationship between changes in brain connectivity and improvements in clinical symptoms. HAMD total scores in the MBCT+TAU group were significantly lower than in the TAU group after 8 weeks of treatment ( p  < 0.001) and at the end of the 3-month follow-up ( p  < 0.001). The increase in functional connections between the amygdala and middle frontal gyrus (MFG) correlated with decreases in HAMA and HAMD scores in the MBCT+TAU group. Diffusion tensor imaging analyses showed that fractional anisotropy of the MFG-amygdala significantly increased in the MBCT+TAU group after 8-week treatment compared with the TAU group. Our study suggested that MBCT improves depression and anxiety symptoms that are associated with LLD. MBCT strengthened functional and structural connections between the amygdala and MFG, and this increase in communication correlated with improvements in clinical symptoms. Randomized Controlled Trial; Follow-Up Study; fMRI; Brain Connectivity.",2022,Diffusion tensor imaging analyses showed that fractional anisotropy of the MFG-amygdala significantly increased in the MBCT+TAU group after 8-week treatment compared with the TAU group.,"['60 participants with LLD', 'Patients']","['Mindfulness-Based Cognitive Therapy', 'Magnetic resonance imaging (MRI', 'MBCT', 'TAU', 'mindfulness-based cognitive therapy (MBCT', 'treatment-as-usual (TAU) group or a MBCT+TAU']","['Hamilton Depression Scale (HAMD) and Hamilton Anxiety Scale (HAMA', 'fractional anisotropy of the MFG-amygdala', 'HAMA and HAMD scores', 'HAMD total scores', 'functional connections', 'depression and anxiety symptoms']","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",60.0,0.117448,Diffusion tensor imaging analyses showed that fractional anisotropy of the MFG-amygdala significantly increased in the MBCT+TAU group after 8-week treatment compared with the TAU group.,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Qianwen', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Ximei', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Sizhen', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Manqiu', 'Initials': 'M', 'LastName': 'Sui', 'Affiliation': 'Beijing Xi Cheng District Pingan Hospital, Beijing, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'National Institute on Drug Dependence and Beijing Key Laboratory of Drug Dependence, Peking University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2022.841461']
3030,35237196,Corrigendum: The LIFEwithIBD Intervention: Study Protocol for a Randomized Controlled Trial of a Face-to-Face Acceptance and Commitment Therapy and Compassion-Based Intervention Tailored to People With Inflammatory Bowel Disease.,[This corrects the article DOI: 10.3389/fpsyt.2021.699367.].,2022,[This corrects the article DOI: 10.3389/fpsyt.2021.699367.].,['People With Inflammatory Bowel Disease'],"['Corrigendum', 'Face-to-Face Acceptance and Commitment Therapy and Compassion-Based Intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.1163,[This corrects the article DOI: 10.3389/fpsyt.2021.699367.].,"[{'ForeName': 'Inês A', 'Initials': 'IA', 'LastName': 'Trindade', 'Affiliation': 'Faculty of Psychology and Education Sciences, CINEICC, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Pereira', 'Affiliation': 'Faculty of Psychology and Education Sciences, CINEICC, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Galhardo', 'Affiliation': 'Faculty of Psychology and Education Sciences, CINEICC, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Nuno B', 'Initials': 'NB', 'LastName': 'Ferreira', 'Affiliation': 'School of Social Sciences, University of Nicosia, Nicosia, Cyprus.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Lucena-Santos', 'Affiliation': 'Faculty of Psychology and Education Sciences, CINEICC, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Sérgio A', 'Initials': 'SA', 'LastName': 'Carvalho', 'Affiliation': 'Faculty of Psychology and Education Sciences, CINEICC, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Oliveira', 'Affiliation': 'Faculty of Psychology and Education Sciences, CINEICC, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Skvarc', 'Affiliation': 'School of Psychology, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Bárbara S', 'Initials': 'BS', 'LastName': 'Rocha', 'Affiliation': 'Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Portela', 'Affiliation': 'Gastroenterology Service, Centro Hospitalar e Universitário de Coimbra (CHUC), Coimbra, Portugal.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Psychology and Education Sciences, CINEICC, University of Coimbra, Coimbra, Portugal.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2022.837357']
3031,35237184,Domain-Based Functional Improvements in Bipolar Disorder After Interpersonal and Social Rhythm Therapy.,"Background


Studies typically report overall change in function when assessing bipolar disorder (BD) interventions, but individual domains are not analyzed. Which aspects of functioning are impacted is clearly important and may differ between treatments.
Methods


Data were analyzed from two previous clinical trials of Interpersonal and Social Rhythm Therapy (IPSRT) for BD patients. Change in total and subscale scores on the Social Adjustment Scale Self-Report (SAS-SR) from 0 to 78 weeks, were analyzed.
Results


152 BD patients took part in randomized controlled trials of IPSRT ( n  = 38) vs. Specialist Supportive Care (SSC) ( n  = 43), and of IPSRT ( n  = 41) vs. treatment as usual (TAU) which was discharge to primary care ( n  = 30). IPSRT was superior to TAU on change in the social and leisure activities and extended family subscales, and SAS-SR total score over 18 months.
Limitations


Studies were not designed to be pooled. Patients in study 1 were younger and symptomatic at baseline. Patients assigned to TAU were more likely to drop-out. Patients did not respond to subscales that were not personally applicable (work, marital, children).
Conclusion


IPSRT had a positive impact on two SAS-SR subscales compared to TAU over 18 months. Other subscales were limited by the lack of respondents due to individual applicability. Different psychotherapy may have differential effects on different domains of function. Measures of function and research into functioning in BD should include domain-based measures, and report the numbers of participants who respond to questions in each domain.",2022,"IPSRT was superior to TAU on change in the social and leisure activities and extended family subscales, and SAS-SR total score over 18 months.
","['152 BD patients', 'Bipolar Disorder']","['IPSRT', 'TAU', 'Specialist Supportive Care (SSC', 'Interpersonal and Social Rhythm Therapy (IPSRT']","['SAS-SR subscales', 'social and leisure activities and extended family subscales, and SAS-SR total score', 'Change in total and subscale scores on the Social Adjustment Scale Self-Report (SAS-SR']","[{'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0451487', 'cui_str': 'Social adjustment scale self - report'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0015341', 'cui_str': 'Extended Family'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",152.0,0.131315,"IPSRT was superior to TAU on change in the social and leisure activities and extended family subscales, and SAS-SR total score over 18 months.
","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Moot', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Crowe', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Inder', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Eggleston', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Frampton', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Porter', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Christchurch, New Zealand.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2022.767629']
3032,35232469,"Comprehensive Anaemia Programme and Personalized Therapies (CAPPT): protocol for a cluster-randomised controlled trial testing the effect women's groups, home counselling and iron supplementation on haemoglobin in pregnancy in southern Nepal.","BACKGROUND


Anaemia in pregnancy remains prevalent in Nepal and causes severe adverse health outcomes.
METHODS


This non-blinded cluster-randomised controlled trial in the plains of Nepal has two study arms: (1) Control: routine antenatal care (ANC); (2) Home visiting, iron supplementation, Participatory Learning and Action (PLA) groups, plus routine ANC. Participants, including women in 54 non-contiguous clusters (mean 2582; range 1299-4865 population) in Southern Kapilbastu district, are eligible if they consent to menstrual monitoring, are resident, married, aged 13-49 years and able to respond to questions. After 1-2 missed menses and a positive pregnancy test, consenting women < 20 weeks' gestation, who plan to reside locally for most of the pregnancy, enrol into trial follow-up. Interventions comprise two home-counselling visits (at 12-21 and 22-26 weeks' gestation) with iron folic acid (IFA) supplement dosage tailored to women's haemoglobin concentration, plus monthly PLA women's group meetings using a dialogical problem-solving approach to engage pregnant women and their families. Home visits and PLA meetings will be facilitated by auxiliary nurse midwives. The hypothesis is as follows: Haemoglobin of women at 30 ± 2 weeks' gestation is ≥ 0.4 g/dL higher in the intervention arm than in the control. A sample of 842 women (421 per arm, average 15.6 per cluster) will provide 88% power, assuming SD 1.2, ICC 0.09 and CV of cluster size 0.27. Outcomes are captured at 30 ± 2 weeks gestation. Primary outcome is haemoglobin concentration (g/dL). Secondary outcomes are as follows: anaemia prevalence (%), mid-upper arm circumference (cm), mean probability of micronutrient adequacy (MPA) and number of ANC visits at a health facility. Indicators to assess pathways to impact include number of IFA tablets consumed during pregnancy, intake of energy (kcal/day) and dietary iron (mg/day), a score of bioavailability-enhancing behaviours and recall of one nutrition knowledge indicator. Costs and cost-effectiveness of the intervention will be estimated from a provider perspective. Using constrained randomisation, we allocated clusters to study arms, ensuring similarity with respect to cluster size, ethnicity, religion and distance to a health facility. Analysis is by intention-to-treat at the individual level, using mixed-effects regression.
DISCUSSION


Findings will inform Nepal government policy on approaches to increase adherence to IFA, improve diets and reduce anaemia in pregnancy.
TRIAL REGISTRATION


ISRCTN 12272130 .",2022,Haemoglobin of women at 30 ± 2 weeks' gestation is ≥ 0.4 g/dL higher in the intervention arm than in the control.,"['in pregnancy in southern Nepal', 'Participants, including women in 54 non-contiguous clusters (mean 2582; range 1299-4865 population) in Southern Kapilbastu district, are eligible if they consent to menstrual monitoring, are resident, married, aged 13-49\u2009years and able to respond to questions', 'A sample of 842 women (421 per arm, average 15.6 per cluster']","['home counselling and iron supplementation on haemoglobin', ""iron folic acid (IFA) supplement dosage tailored to women's haemoglobin concentration, plus monthly PLA women's group meetings using a dialogical problem-solving approach"", 'Comprehensive Anaemia Programme and Personalized Therapies (CAPPT', 'Control: routine antenatal care (ANC); (2) Home visiting, iron supplementation, Participatory Learning and Action (PLA) groups, plus routine ANC']","['anaemia prevalence ', 'Costs and cost-effectiveness', 'haemoglobin concentration (g/dL', 'score of bioavailability-enhancing behaviours and recall of one nutrition knowledge indicator', ' mid-upper arm circumference (cm), mean probability of micronutrient adequacy (MPA) and number of ANC visits at a health facility']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205283', 'cui_str': 'Contiguous'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0357067', 'cui_str': 'Folic acid- and iron-containing product'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0242543', 'cui_str': ""Women's Groups""}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1276362', 'cui_str': 'Routine antenatal care'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]",842.0,0.201714,Haemoglobin of women at 30 ± 2 weeks' gestation is ≥ 0.4 g/dL higher in the intervention arm than in the control.,"[{'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Saville', 'Affiliation': 'Institute for Global Health, University College London (UCL), London, UK. n.saville@ucl.ac.uk.'}, {'ForeName': 'Chandani', 'Initials': 'C', 'LastName': 'Kharel', 'Affiliation': 'HERD International, Thapathali, Kathmandu, Nepal.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'Institute for Global Health, University College London (UCL), London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Harris-Fry', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine (LSHTM), London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'James', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine (LSHTM), London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Copas', 'Affiliation': 'Institute for Global Health, University College London (UCL), London, UK.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Giri', 'Affiliation': 'HERD International, Thapathali, Kathmandu, Nepal.'}, {'ForeName': 'Abriti', 'Initials': 'A', 'LastName': 'Arjyal', 'Affiliation': 'HERD International, Thapathali, Kathmandu, Nepal.'}, {'ForeName': 'B James', 'Initials': 'BJ', 'LastName': 'Beard', 'Affiliation': ', Guildford, GU1 3LD, UK.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Haghparast-Bidgoli', 'Affiliation': 'Institute for Global Health, University College London (UCL), London, UK.'}, {'ForeName': 'Jolene', 'Initials': 'J', 'LastName': 'Skordis', 'Affiliation': 'Institute for Global Health, University College London (UCL), London, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Richter', 'Affiliation': 'Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Sushil', 'Initials': 'S', 'LastName': 'Baral', 'Affiliation': 'HERD International, Thapathali, Kathmandu, Nepal.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hillman', 'Affiliation': ""Institute for Women's Health, University College London (UCL), London, UK.""}]",Trials,['10.1186/s13063-022-06043-z']
3033,35232426,Effect of later cord clamping on umbilical cord blood gas in term neonates of diabetic mothers: a randomized clinical trial.,"OBJECTIVE


To evaluate the effect of later cord clamping (LCC) on umbilical arterial blood gas in neonates of diabetic mothers.
METHODS


This prospective study included a group of 160 diabetic mothers (DM) whose neonates were randomized to immediate cord clamping (ICC) (≤ 15 s after birth) or LCC (≥ 30 s after birth), and a group of 208 non-diabetic mothers (NDM) whose neonates were randomized to ICC or LCC as a reference. Cord arterial pH, base excess (BE), bicarbonate (HCO 3 - ), partial pressure of carbon dioxide (pCO 2 ), partial pressure of oxygen (pO 2 ), lactate, hemoglobin, hematocrit and glucose were compared among groups.
RESULTS


In neonates of DM, there was no significant difference in cord arterial pH between the ICC and LCC group. LCC of ≥ 30 s decreased umbilical arterial HCO 3 -  and BE and increased lactate (ICC versus LCC, HCO 3 - : 24.3 (22.7, 25.8) versus 23.7 (22.3, 24.7) mmol/L, P = 0.01; BE: -2.70 (-4.80, -1.50) versus - 3.72 (-5.66, -2.36) mmol/L, P = 0.006; lactate: 2.1 (1.6, 3.7) versus 2.7 (2.1, 4.3) mmol/L, P = 0.005), without the alterations of pCO 2 , pO 2 , hemoglobin, hematocrit and glucose. Similar results were found in neonates of NDM (ICC versus LCC, HCO 3 - : 24.3 (23.1, 25.7) versus 23.5 (22.3, 24.8) mmol/L, P = 0.01; BE: -2.39 (-3.73, -1.51) versus - 3.40 (-4.73, -1.91) mmol/L, P = 0.001; lactate: 2.2 (1.9, 3.3) versus 2.5 (2.0, 4.3) mmol/L, P = 0.01), except for the higher level of hemoglobin in the LCC group. The majority of diabetic mothers (ICC: 92.0%; LCC: 91.8%) had good blood glucose control. No differences were observed in acid-base status and glucose between neonates of DM and neonates of NDM in both ICC and LCC, but hemoglobin and hematocrit were elevated after ICC in neonates of DM compared to neonates of NDM.
CONCLUSIONS


Later cord clamping of ≥ 30 s resulted in a tendency towards metabolic acidosis of umbilical arterial blood in neonates of DM and NDM. Umbilical arterial blood gas parameters at birth were similar in neonates of DM and NDM.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT04369313 ; date of registration: 30/04/2020 (retrospectively registered).",2022,"No differences were observed in acid-base status and glucose between neonates of DM and neonates of NDM in both ICC and LCC, but hemoglobin and hematocrit were elevated after ICC in neonates of DM compared to neonates of NDM.
","['208 non-diabetic mothers (NDM) whose neonates', 'term neonates of diabetic mothers', 'neonates of diabetic mothers', 'Later cord clamping of ≥', '160 diabetic mothers (DM']","['BE', 'immediate cord clamping (ICC) (≤\u200915\xa0s after birth) or LCC (≥', 'later cord clamping', 'ICC or LCC', 'later cord clamping (LCC']","['umbilical arterial HCO 3 -  and BE and increased lactate (ICC', 'umbilical cord blood gas', 'good blood glucose control', 'acid-base status and glucose', 'neonates of NDM (ICC', 'umbilical arterial blood gas', 'Cord arterial pH, base excess (BE), bicarbonate (HCO 3 - ), partial pressure of carbon dioxide (pCO 2 ), partial pressure of oxygen (pO 2 ), lactate, hemoglobin, hematocrit and glucose', 'LCC of ≥', 'cord arterial pH', 'Umbilical arterial blood gas parameters', 'metabolic acidosis of umbilical arterial blood', 'hemoglobin, hematocrit and glucose', 'hemoglobin and hematocrit']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0201985', 'cui_str': 'Delta base, blood'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0201985', 'cui_str': 'Delta base, blood'}, {'cui': 'C0392691', 'cui_str': 'Increased lactic acid level'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0428199', 'cui_str': 'pH measurement, arterial'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}]",208.0,0.0770019,"No differences were observed in acid-base status and glucose between neonates of DM and neonates of NDM in both ICC and LCC, but hemoglobin and hematocrit were elevated after ICC in neonates of DM compared to neonates of NDM.
","[{'ForeName': 'Hailing', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': 'Department of Obstetrics and Gynecology, the Second Affiliated Hospital of Wenzhou Medical University, 325027, Wenzhou, China.'}, {'ForeName': 'Yehui', 'Initials': 'Y', 'LastName': 'Lan', 'Affiliation': 'Department of Obstetrics and Gynecology, the Second Affiliated Hospital of Wenzhou Medical University, 325027, Wenzhou, China.'}, {'ForeName': 'Yiyu', 'Initials': 'Y', 'LastName': 'Qian', 'Affiliation': 'Department of Obstetrics and Gynecology, the Second Affiliated Hospital of Wenzhou Medical University, 325027, Wenzhou, China.'}, {'ForeName': 'Ruyang', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, Wenzhou Central Hospital, 325000, Wenzhou, China.'}, {'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Gynecology, Wenzhou People Hospital, 325000, Wenzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Hua', 'Affiliation': 'Department of Obstetrics and Gynecology, the Second Affiliated Hospital of Wenzhou Medical University, 325027, Wenzhou, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, the Second Affiliated Hospital of Wenzhou Medical University, 325027, Wenzhou, China. wangxiaomei12321@163.com.'}]",BMC pediatrics,['10.1186/s12887-022-03170-z']
3034,35232423,Comparison of oral Dydrogesterone and 17-α hydroxyprogesterone caprate in the prevention of preterm birth.,"BACKGROUND


Preterm birth (PTB) remains a significant problem in obstetric care. Progesterone supplements are believed to reduce the rate of preterm labor, but formulation, type of administration, and dosage varies in different studies. This study was performed to compare oral Dydrogesterone with intramuscular 17α-hydroxyprogesterone caproate (17α-OHPC) administration in prevention of PTB.
METHODS


In this randomized clinical trial, we studied 150 women with singleton pregnancy in 28 Th -34 Th  Gestational week, who had received tocolytic treatment for preterm labor. Participants were divided to receive 30 mg oral Dydrogesterone daily, 250 mg intramuscular 17α-OHPC weekly, or no intervention (control group). All treatments were continued until 37 Th  Week or delivery, whichever occurred earlier. Obstetric outcomes, including latency period, gestational age at delivery, birth weight, neonatal intensive care unit (NICU) admission, and neonatal mortality were recorded. All patients were monitored biweekly until delivery.
RESULTS


Baseline gestational age was not significantly different between groups. Latency period was significantly longer in the progesterone group compared with Dydrogesterone and control groups (41.06 ± 17.29 vs. 29.44 ± 15.6 and 22.20 ± 4.51 days, respectively; P < 0.001). The progesterone group showed significantly better results compared with the other two groups, in terms of gestational age at delivery, birth weight, and Apgar score (P < 0.001). None of the participants showed severe complications, stillbirth, or gestational diabetes.
CONCLUSION


Progesterone caproate can strongly prolong the latency period and improve neonatal outcomes and therefore, is superior to oral Dydrogesterone in the prevention of PTB.",2022,"The progesterone group showed significantly better results compared with the other two groups, in terms of gestational age at delivery, birth weight, and Apgar score (P < 0.001).","['150 women with singleton pregnancy in 28 Th -34 Th \xa0Gestational week, who had received\xa0tocolytic\xa0treatment for preterm labor', 'preterm birth']","['Progesterone supplements', 'Progesterone\xa0caproate', 'oral Dydrogesterone and 17-α\xa0hydroxyprogesterone', '30\xa0mg oral Dydrogesterone', 'progesterone', '250\xa0mg intramuscular\xa017α-OHPC\xa0weekly, or no intervention (control group', 'Dydrogesterone with intramuscular 17α-hydroxyprogesterone caproate (17α-OHPC', 'Dydrogesterone']","['Latency period', 'Obstetric outcomes, including latency period, gestational age at delivery, birth weight, neonatal intensive care unit (NICU) admission, and neonatal mortality', 'severe complications, stillbirth, or gestational diabetes', 'gestational age at delivery, birth weight, and Apgar score', 'rate of preterm labor']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040348', 'cui_str': 'Tocolysis'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0006924', 'cui_str': 'Hexanoates'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013340', 'cui_str': 'Dydrogesterone'}, {'cui': 'C0020387', 'cui_str': 'Hydroxyprogesterone'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0044971', 'cui_str': 'Hydroxyprogesterone caproate'}]","[{'cui': 'C0023103', 'cui_str': 'Latency Period (Psychology)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}]",150.0,0.118267,"The progesterone group showed significantly better results compared with the other two groups, in terms of gestational age at delivery, birth weight, and Apgar score (P < 0.001).","[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Alizadeh', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicines, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Mahmoudinia', 'Affiliation': 'Department of Obstetrics, Faculty of Medicines, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Mirteimoori', 'Affiliation': 'Faculty of Medicines, Mashhad University of Medical Sciences, Mashhad, Iran. Mirteimourim@mums.ac.ir.'}, {'ForeName': 'Lila', 'Initials': 'L', 'LastName': 'Pourali', 'Affiliation': 'Department of Obstetrics, Faculty of Medicines, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'Niroumand', 'Affiliation': 'Faculty of Medicines, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",BMC pregnancy and childbirth,['10.1186/s12884-022-04509-1']
3035,35232402,"Effects of school-based high-intensity interval training on body composition, cardiorespiratory fitness and cardiometabolic markers in adolescent boys with obesity: a randomized controlled trial.","BACKGROUND


With accumulating evidence suggesting that CVD has its origins in childhood obesity. The purpose of this study was to determine the effect of a real-world school-based high-intensity interval training intervention on body composition, cardiorespiratory fitness and cardiometabolic markers in obese boys aged 10 to 13 years.
METHODS


Forty-five adolescent boys with obesity (age = 11.2 ± 0.7 years, BMI = 24.2 ± 1.0 kg/m 2 ), were randomized to high-intensity interval training group (HIIT, n = 15), moderate-intensity continuous training group (MICT, n = 15), or a control group (CON, n = 15). The intervention groups performed three weekly exercise sessions over 12 weeks. HIIT group performed two sets of eight bouts of 15 s run at high-intensity [90 ~ 100% maximal aerobic speed (MAS)] separated by eight bouts of 15 s recovery run at low-intensity (50% MAS), MICT group performed 30 min run at moderate intensity (60 ~ 70% MAS) and CON group were instructed to continue their normal behaviors. All participants had indices of body composition, cardiorespiratory fitness (CRF) and cardiometabolic markers measured at baseline and post-intervention. Statistical differences between and within groups were determined by use of two-way analysis of variance (ANOVA) with repeated measures.
RESULTS


Following the school-based training program, BMI and body fat mass decreased (BMI: - 1.8 kg/m 2  vs. - 1.2 kg/m 2 , P < 0.01; FM: - 1.6 kg, P < 0.05 vs. -3.7 kg, P < 0.01) in HIIT and MICT group, but there was no significant difference between the two interventions; [Formula: see text] both increased significantly in two intervention groups, and the increment of HIIT group was significantly greater than that of MICT (6.1 mL/kg/min vs. 3.8 mL/kg/min, P < 0.01), Visceral adipose tissue was significant decrease in HIIT group (- 53 g vs. -17 g, P < 0.01) whilst the MICT group experienced a significant decrease in body fat percentage (- 3.1 ± 1.0 kg, P < 0.01), but there were no significant difference between the two interventions. Low-density lipoprotein cholesterol decreased only in HIIT group (- 17.2%, P < 0.05). Significant decrease in the usual index of insulin resistance (HOMA-IR) occurred in HIIT and MICT groups (- 27.3 and - 28.6%, respectively; P < 0.05).
CONCLUSIONS


Our results demonstrated that high-intensity interval training based on running can be used to improve the physical health of obese adolescents in school. Further investigations involving a larger cohort of participants, taken from different schools, is recommended.
TRIAL REGISTRATION


title Effect of High Intensity Interval Training on Obese Children and Adolescents, time 16/12/2017, ID ChiCTR-IOR-17013992 , website http://www.chictr.org.cn.",2022,"Low-density lipoprotein cholesterol decreased only in HIIT group (- 17.2%, P < 0.05).","['obese boys aged 10 to 13\u2009years', 'obese adolescents in school', 'Forty-five adolescent boys with obesity (age\u2009=\u200911.2\u2009±\u20090.7\u2009years, BMI\u2009=\u200924.2\u2009±\u20091.0\u2009kg/m 2 ', 'adolescent boys with obesity']","['real-world school-based high-intensity interval training intervention', 'high-intensity interval training group (HIIT, n\u2009=\u200915), moderate-intensity continuous training group (MICT, n\u2009=\u200915), or a control group (CON', 'school-based high-intensity interval training', '15\u2009s run at high-intensity [90\u2009~\u2009100% maximal aerobic speed (MAS)] separated by eight bouts of 15\u2009s recovery run at low-intensity (50% MAS), MICT group performed 30\u2009min run at moderate intensity (60\u2009~\u200970% MAS) and CON', 'High Intensity Interval Training', 'MICT']","['Low-density lipoprotein cholesterol', 'usual index of insulin resistance (HOMA-IR', 'BMI and body fat mass', 'body composition, cardiorespiratory fitness (CRF) and cardiometabolic markers', 'body fat percentage', 'Visceral adipose tissue', 'body composition, cardiorespiratory fitness and cardiometabolic markers']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}]",45.0,0.00816643,"Low-density lipoprotein cholesterol decreased only in HIIT group (- 17.2%, P < 0.05).","[{'ForeName': 'Cao', 'Initials': 'C', 'LastName': 'Meng', 'Affiliation': 'Institute of Physical Education, Normal College, Shenzhen University, 3688 Nan Hai Road, Nan Shan district, Shenzhen, 518061, China. caomengsus@163.com.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Yucheng', 'Affiliation': 'Institute of Physical Education, Normal College, Shenzhen University, 3688 Nan Hai Road, Nan Shan district, Shenzhen, 518061, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shu', 'Affiliation': 'Institute of Physical Education, Normal College, Shenzhen University, 3688 Nan Hai Road, Nan Shan district, Shenzhen, 518061, China.'}, {'ForeName': 'Zou', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'College of Education, Zhejiang University, Zhejiang, 310058, China.'}]",BMC pediatrics,['10.1186/s12887-021-03079-z']
3036,35232894,"A Randomized, Double-Blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of DA-9701 (Motilitone) in Patients With Functional Dyspepsia and Constipation-type Irritable Bowel Syndrome Overlap: A Pilot Study.","Background/Aims


To assess the effects and safety of DA-9701 in patients with constipation-type irritable bowel syndrome (IBS-C) which frequently accompany functional dyspepsia (FD).
Methods


FD and IBS-C were diagnosed based on the Rome III criteria. Randomized subjects were administered 30 mg of DA-9701 (Motilitone) or placebo 3 times a day for 4 weeks. The study endpoints were evaluated the percentage of responders in the overall symptom evaluation of IBS-C and FD.
Results


Thirty IBS-C patients and 30 placebos were prospectively enrolled. The proportion of responders with improvement in overall symptoms of IBS-C was 53.33% in the DA-9701 group and 40.00% in the placebo group ( P  = 0.301). Compared to the placebo group, the decrease of abdominal pain score in the DA-9701 group was significantly higher at week 3 in the DA-9701 group (0.96 ± 0.77 vs 0.55 ± 0.79,  P  = 0.042) but no significance at week 4. There was no significant difference in total IBS quality of life score at week 4 between the 2 groups ( P  = 0.897). Among patients with IBS-C accompanied by FD, the proportion of responders in the DA-9701 group was 50.00% (15/30), which was higher than 31.03% (9/29) of the placebo group ( P  = 0.138).
Conclusions


DA-9701 showed trend of treatment efficacy in patients with FD and IBS-C overlap including overall improvement, and safety, compared to placebo but without significance probably due to small numbers. It is suggested the need for a large-scale clinical trial to confirm this preliminary effect of DA-9701.",2022,There was no significant difference in total IBS quality of life score at week 4 between the 2 groups ( P  = 0.897).,"['Patients With Functional Dyspepsia and Constipation-type Irritable Bowel Syndrome Overlap', 'Thirty IBS-C patients and 30 placebos were prospectively enrolled', 'patients with constipation-type irritable bowel syndrome (IBS-C) which frequently accompany functional dyspepsia (FD']","['placebo', 'DA-9701 (Motilitone) or placebo', 'Placebo', 'DA-9701', 'DA-9701 (Motilitone']","['overall symptoms of IBS-C', 'overall symptom evaluation of IBS-C and FD', 'total IBS quality of life score', 'abdominal pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2606904', 'cui_str': 'DA-9701'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C3494438', 'cui_str': 'Symptom Evaluation'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",30.0,0.30225,There was no significant difference in total IBS quality of life score at week 4 between the 2 groups ( P  = 0.897).,"[{'ForeName': 'Ju Yup', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoungnam, South Korea.'}, {'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoungnam, South Korea.'}, {'ForeName': 'Hyuk', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoungnam, South Korea.'}, {'ForeName': 'Cheol Min', 'Initials': 'CM', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoungnam, South Korea.'}, {'ForeName': 'Young Soo', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoungnam, South Korea.'}, {'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoungnam, South Korea.'}]",Journal of neurogastroenterology and motility,['10.5056/jnm20236']
3037,35233271,Effectiveness of Functional Electrical Stimulation - Cycling Treatment in Children with Cerebral Palsy.,"Aim


The purpose of this study was to evaluate the effects of functional electrical stimulation (FES) bicycle therapy system on motor function, gait pattern, spasticity, daily living activities, and aerobic capacity in children with cerebral palsy (CP) and to compare the results with sham stimulation and standard treatment.
Methods


Patients with cerebral palsy who received botulinum toxin type-A injections to lower extremities and those with Gross Motor Function Measure Classification System (GMFCS) levels I - III, were included in the study. Twenty-five patients were randomly assigned into three treatment groups for 4-weeks: Group 1, FES-cycling and standard treatment; Group 2, Sham stimulus FES-cycling and standard treatment; Group 3, Standard treatment. Clinical assessment tools included the Modified Ashworth Scale (MAS), Modified Tardieu Scale (MTS), Pediatric Functional Independence Measure (WeeFIM), GMFCS, Gross Motor Function Measure-88 (GMFM-88), selective motor control tests, 6-minute walk test, and Visual Gait Analysis (VGA).
Results


In all groups, there were significant improvements in MAS, MTS, WeeFIM, GMFM-88, 6-minute walk test, and VGA scores. No changes in GMFCS levels were observed in any group. At the end of the study, there was no significant difference among the groups in terms of any clinical assessment parameter.
Conclusions


All groups showed statistically significant improvements in motor function, walking pattern, spasticity, daily living activities, and aerobic capacity in patients with CP following the rehabilitation period. Although FES-cycling demonstrated no superiority over the other approaches and provided no additional benefit to the results, FES appears to be safe and well-tolerated in children with CP, at least as much as standard exercise treatment.",2021,"All groups showed statistically significant improvements in motor function, walking pattern, spasticity, daily living activities, and aerobic capacity in patients with CP following the rehabilitation period.","['Patients with cerebral palsy', 'GMFCS) levels I - III, were included in the study', 'Children with Cerebral Palsy', 'Twenty-five patients', 'children with cerebral palsy (CP']","['functional electrical stimulation (FES) bicycle therapy system', 'FES-cycling and standard treatment; Group 2, Sham stimulus FES-cycling and standard treatment; Group 3, Standard treatment', 'botulinum toxin type-A injections to lower extremities and those with Gross Motor Function Measure Classification System', 'Functional Electrical Stimulation - Cycling Treatment']","['motor function, walking pattern, spasticity, daily living activities, and aerobic capacity', 'MAS, MTS, WeeFIM, GMFM-88, 6-minute walk test, and VGA scores', 'Modified Ashworth Scale (MAS), Modified Tardieu Scale (MTS), Pediatric Functional Independence Measure (WeeFIM), GMFCS, Gross Motor Function Measure-88 (GMFM-88), selective motor control tests, 6-minute walk test, and Visual Gait Analysis (VGA', 'GMFCS levels', 'motor function, gait pattern, spasticity, daily living activities, and aerobic capacity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C4060200', 'cui_str': 'Botulinum Toxin Type A Injection [Botox]'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0796074', 'cui_str': 'Deafness-dystonia-optic neuronopathy syndrome'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C4720933', 'cui_str': 'Motor control test'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",25.0,0.0294077,"All groups showed statistically significant improvements in motor function, walking pattern, spasticity, daily living activities, and aerobic capacity in patients with CP following the rehabilitation period.","[{'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Özen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara Turkey.'}, {'ForeName': 'Ece', 'Initials': 'E', 'LastName': 'Unlu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara Turkey.'}, {'ForeName': 'Ozgur Zeliha', 'Initials': 'OZ', 'LastName': 'Karaahmet', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara Turkey.'}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Gurcay', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara Turkey.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Gundogdu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Umay', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara Turkey.'}]",Malawi medical journal : the journal of Medical Association of Malawi,['10.4314/mmj.v33i3.1']
3038,35233214,Late primary angioplasty (beyond 12 h): are we sure it should be avoided?,"Optimal management for patients with ST-segment elevation myocardial infarction (STEMI) who arrive at a hospital late remains uncertain since evidence and real-world data are limited. Patients who present late with a STEMI are a heterogeneous population, and the clinical decision regarding percutaneous coronary intervention (PCI) should not be the same for all. One randomized clinical trial, multiple mechanistic studies, and contemporary registries suggest a presumed benefit for a prompt restoration of coronary flow even in late presenting STEMI. Crucial elements in decision-making are the presence of haemodynamic or electrical instability, and ongoing ischaemic signs or symptoms to tip the scales toward PCI. Among clinically stable, late-presenting patients, myocardial viability assessment and functional testing can identify yet another subgroup that may benefit from late PCI.",2021,Optimal management for patients with ST-segment elevation myocardial infarction (STEMI) who arrive at a hospital late remains uncertain since evidence and real-world data are limited.,"['patients with ST-segment elevation myocardial infarction (STEMI', 'Patients who present late with a STEMI are a heterogeneous population, and the clinical decision regarding percutaneous coronary intervention (PCI']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",[],[],,0.0484478,Optimal management for patients with ST-segment elevation myocardial infarction (STEMI) who arrive at a hospital late remains uncertain since evidence and real-world data are limited.,"[{'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bolognese', 'Affiliation': 'Cardiovascular Department, Azienda Ospedaliera Toscana Sudest, Via Pietro Nenni 22, Arezzo, Italy.'}]",European heart journal supplements : journal of the European Society of Cardiology,['10.1093/eurheartj/suab086']
3039,35233508,Immunochemotherapy and Maintenance With Obinutuzumab or Rituximab in Patients With Previously Untreated Marginal Zone Lymphoma in the Randomized GALLIUM Trial.,"The aim of this study was to explore the efficacy and safety of obinutuzumab (G)- versus rituximab (R)-chemotherapy in a subgroup of patients with previously untreated marginal zone lymphoma (MZL) in the phase III GALLIUM trial (NCT01332968). Patients had stage III/IV (or stage II with bulky disease), splenic, nodal, or extranodal MZL requiring treatment. Patients were randomized 1:1 to receive G- or R-chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone; cyclophosphamide, vincristine, and prednisone; or bendamustine, allocated at patient level). Patients with complete/partial response at the end of induction (EOI) received G/R maintenance. Investigator-assessed progression-free survival (PFS), other time-to-event endpoints, response, and safety were assessed. Overall, 195 patients with MZL were included in this analysis: G-chemotherapy (n = 99), R-chemotherapy (n = 96). Median observation time: 59.3 months. No meaningful difference was observed between arms for PFS (4-y PFS rates: G-chemotherapy, 72.6%; R-chemotherapy, 64.1%), other time-to-event endpoints, or EOI response rates (by computed tomography [CT; G-chemotherapy, 81.8%; R-chemotherapy, 81.3%] and positron emission tomography CT [G-chemotherapy, 79.2%; R-chemotherapy, 87.5%]). All patients experienced ≥1 adverse event (AE). G-chemotherapy was associated with a higher incidence of grade 3-5 (86.1% versus 77.4%), grade 5 (14.9% versus 9.7%), and serious (66.3% versus 51.6%) AEs versus R-chemotherapy. Both arms had a higher incidence of grade 3-5 and serious AEs than patients with follicular lymphoma (GALLIUM), with G-chemotherapy being less tolerable than R-chemotherapy. Based on the observed tolerability of G-chemotherapy versus R-chemotherapy, and the comparable efficacy of G-chemotherapy and R-chemotherapy in this analysis, G-chemotherapy cannot be recommended as first-line treatment for MZL.",2022,"Both arms had a higher incidence of grade 3-5 and serious AEs than patients with follicular lymphoma (GALLIUM), with G-chemotherapy being less tolerable than R-chemotherapy.","['Patients had stage III/IV (or stage II with bulky disease), splenic, nodal, or extranodal MZL requiring treatment', '195 patients with MZL were included in this analysis: G-chemotherapy (n = 99), R-chemotherapy (n = 96', 'subgroup of patients with previously untreated marginal zone lymphoma (MZL', 'Patients With Previously Untreated Marginal Zone Lymphoma']","['G-chemotherapy and R-chemotherapy', 'G-chemotherapy versus R-chemotherapy', 'G-chemotherapy', 'obinutuzumab (G)- versus rituximab (R)-chemotherapy', 'Immunochemotherapy and Maintenance With Obinutuzumab or Rituximab', 'G- or R-chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone; cyclophosphamide, vincristine, and prednisone; or bendamustine']","['Investigator-assessed progression-free survival (PFS), other time-to-event endpoints, response, and safety', 'efficacy and safety', 'time-to-event endpoints, or EOI response rates', '≥1 adverse event (AE']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C1367654', 'cui_str': 'Marginal zone B-cell lymphoma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0242647', 'cui_str': 'Mucosa-associated lymphoma'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",195.0,0.0760929,"Both arms had a higher incidence of grade 3-5 and serious AEs than patients with follicular lymphoma (GALLIUM), with G-chemotherapy being less tolerable than R-chemotherapy.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Herold', 'Affiliation': 'Helios Klinikum Erfurt, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hoster', 'Affiliation': 'Department of Medicine III, Ludwig-Maximilians-University Hospital Munich, Germany.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Janssens', 'Affiliation': 'Department of Hematology, Universitaire Ziekenhuizen Leuven, Belgium.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Department of Haematology, Royal Bournemouth General Hospital, Bournemouth, United Kingdom.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tedeschi', 'Affiliation': 'Department of Hematology, Niguarda Hospital, Milan, Italy.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Pocock', 'Affiliation': 'East Kent Hospitals NHS Trust, Canterbury, United Kingdom.'}, {'ForeName': 'Andras', 'Initials': 'A', 'LastName': 'Rosta', 'Affiliation': 'Department of Haematology, Országos Onkológiai Intézet, Budapest, Hungary.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Trněný', 'Affiliation': '1 Faculty of Medicine, Charles University General Hospital, Prague, Czech Republic.'}, {'ForeName': 'Tina G', 'Initials': 'TG', 'LastName': 'Nielsen', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Knapp', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hiddemann', 'Affiliation': 'Department of Medicine III, Ludwig-Maximilians-University Hospital Munich, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Marcus', 'Affiliation': 'HCA Healthcare, London, United Kingdom.'}]",HemaSphere,['10.1097/HS9.0000000000000699']
3040,35233478,Plasma Choline Concentration Was Not Increased After a 6-Month Egg Intervention in 6-9-Month-Old Malawian Children: Results from a Randomized Controlled Trial.,"Background


Eggs are a rich source of choline, an essential nutrient important for child growth and development. In a randomized trial of 1 egg/d in young children in Ecuador, an egg intervention led to significant improvements in growth, which were partially mediated by increased plasma choline concentration. A similar trial in Malawi (clinicaltrials.gov: NCT03385252) found little improvement in child growth or development.
Objectives


We aimed to evaluate the effect of 1 egg/d for 6 mo on plasma choline concentrations in Malawian children enrolled in a randomized trial.
Methods


Infants aged 6-9 mo in rural Malawi were randomly assigned to receive 1 egg/d ( n  = 331) or serve as a nonintervention control ( n  = 329) for 6 mo. Anthropometric, developmental, and dietary data were collected at baseline and 6-mo follow-up, along with a blood draw. Plasma choline, betaine, dimethylglycine, trimethylamine  N -oxide (TMAO), and DHA were measured at both time points using ultrahigh performance liquid chromatography-tandem MS ( n  = 200 per group). Linear regression analysis was used to determine the difference in plasma choline and related metabolites between groups after 6 mo of intervention.
Results


Plasma choline, betaine, dimethylglycine, and DHA concentrations did not differ between groups at 6-mo follow-up. Plasma TMAO was significantly (26%; 95% CI: 7%, 48%) higher in the egg intervention group in a fully adjusted model.
Conclusions


Provision of 1 egg/d for 6 mo did not result in increases in plasma choline or related metabolites, except TMAO. This could partially explain the lack of effect on growth and development. Additional interventions are needed to improve choline status, growth, and development in this population.",2022,"Plasma TMAO was significantly (26%; 95% CI: 7%, 48%) higher in the egg intervention group in a fully adjusted model.
","['Malawian children enrolled in a randomized trial', 'young children in Ecuador', '6-9-Month-Old Malawian Children', 'Methods\n\n\nInfants aged 6-9 mo in rural Malawi']",['nonintervention control'],"['Plasma TMAO', 'plasma choline concentrations', 'N -oxide (TMAO), and DHA', 'plasma choline concentration', 'Plasma choline, betaine, dimethylglycine, trimethylamine', 'Plasma choline, betaine, dimethylglycine, and DHA concentrations', 'Plasma Choline Concentration', 'plasma choline or related metabolites, except TMAO', 'plasma choline and related metabolites', 'Anthropometric, developmental, and dietary data']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0013593', 'cui_str': 'Ecuador'}, {'cui': 'C0442751', 'cui_str': 'Distance vision 6/9'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0058265', 'cui_str': 'dimethylglycine'}, {'cui': 'C0077172', 'cui_str': 'trimethylamine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",,0.207409,"Plasma TMAO was significantly (26%; 95% CI: 7%, 48%) higher in the egg intervention group in a fully adjusted model.
","[{'ForeName': 'Megan G', 'Initials': 'MG', 'LastName': 'Bragg', 'Affiliation': 'Institute for Global Nutrition, Department of Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Prado', 'Affiliation': 'Institute for Global Nutrition, Department of Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Institute for Global Nutrition, Department of Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Zyba', 'Affiliation': 'Institute for Global Nutrition, Department of Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Maleta', 'Affiliation': 'School of Public Health and Family Medicine, Kamuzu University of Health Sciences, Blantyre, Malawi.'}, {'ForeName': 'Bess L', 'Initials': 'BL', 'LastName': 'Caswell', 'Affiliation': 'USDA Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Bennett', 'Affiliation': 'USDA Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Iannotti', 'Affiliation': 'Brown School, Institute for Public Health, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'Chessa K', 'Initials': 'CK', 'LastName': 'Lutter', 'Affiliation': 'RTI International, Washington DC, USA.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Institute for Global Nutrition, Department of Nutrition, University of California Davis, Davis, CA, USA.'}]",Current developments in nutrition,['10.1093/cdn/nzab150']
3041,35233429,The effect of training program of health promotion behaviors on geriatric general health components.,"BACKGROUND


Increasing in elderly's population and their individual and social problems especially mental health problem in this group need special attention. The aim of this study was evaluation of health promotion behaviors training program efficacy on general health components in elderlies referring to health centers in Isfahan city.
MATERIALS AND METHODS


This study was a tri phasic field trial in 2014 in which 72 elderlies allocated randomly in two case and control groups. Case group participated in 9 training sessions on stress management and interpersonal relationships and the control group participated in 2 sessions with a neutral discussion content. Data collection tools were demographic information questionnaire and general health questionnaire 28. Pretest, posttest, and 2-month follow-up were performed in two groups. Data were analyzed by  t -test, analysis of variance with repeated measurement, least significant difference  post hoc  test, and SPSS 20 software.
RESULTS


Findings of this study showed that the average of general health score in case and control groups had not significant difference before the intervention ( P  > 0.05). However, the mean difference of general health score after intervention and 2-month follow-up was statistically significant in two groups ( P  < 0.001).
CONCLUSIONS


This study showed that interpersonal relationship and stress management training program are effective on promotion of mental health in elderlies. Hence, the findings of this study can be used in the field of treatment and care of the elderly by other health-care categories.",2021,"However, the mean difference of general health score after intervention and 2-month follow-up was statistically significant in two groups ( P  < 0.001).
","['2014 in which 72 elderlies allocated randomly in two case and control groups', 'elderlies referring to health centers in Isfahan city', 'geriatric general health components', 'mental health in elderlies']","['health promotion behaviors training program efficacy', 'training program of health promotion behaviors', '9 training sessions on stress management and interpersonal relationships and the control group participated in 2 sessions with a neutral discussion content', 'interpersonal relationship and stress management training program']",['general health score'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.00736287,"However, the mean difference of general health score after intervention and 2-month follow-up was statistically significant in two groups ( P  < 0.001).
","[{'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Kheirabadi', 'Affiliation': 'Department of Psychiatry, Behavioral Sciences Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mehrnoosh', 'Initials': 'M', 'LastName': 'Shirani', 'Affiliation': 'Nursing Student Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahrokh', 'Initials': 'M', 'LastName': 'Keshvari', 'Affiliation': 'Department of Community Health and Gerontological Nursing, Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Sharifirad', 'Affiliation': 'Department of Health Education, School of Health, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Mahboobe', 'Initials': 'M', 'LastName': 'Bahrami', 'Affiliation': 'Department of Psychiatry, Behavioral Sciences Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_223_21']
3042,35233424,Problem-based learning as an effective method for teaching theoretical surgery courses to medical students.,"BACKGROUND


This study was designed to assess the clinical judgment of medical students in surgery clinical decision-making by a standard examination after lecture-based learning (LBL) or problem-based learning (PBL).
MATERIALS AND METHODS


A prospective randomized trial study on 175 medical students whom were randomly allocated to three groups was performed during November 2017 and January 2018. LBL group ( n  = 103), PBL group led by an attending ( n  = 39), and PBL group ( n  = 33) led by an intern. Chi-squared test and independent student  t -test were used to compare between the two groups. All the analyses were performed by the two-sided method using the Statistical Package for the Social Sciences software (SPSS version 22; SPSS, Inc., Chicago, IL, USA), and a  P  < 0.05 set as statistically significant.
RESULTS


The students in the PBL group scored significantly higher on the posttraining multiple-choice examination, compared to the LBL group ( P  = 0.048). However, there was no significant difference between the PBL group led by an attending and the PBL group led by an intern ( P  = 0.892).
CONCLUSION


We concluded that PBL remarkably increased the students' scores in the problem-solving examination, as compared to the conventional method. We found no significant differences in PBL facilitated by an attending or an intern.",2021,"The students in the PBL group scored significantly higher on the posttraining multiple-choice examination, compared to the LBL group ( P  = 0.048).",['175 medical students whom were randomly allocated to three groups was performed during November 2017 and January 2018'],"['lecture-based learning (LBL) or problem-based learning (PBL', 'Problem-based learning', 'LBL', 'PBL']","['posttraining multiple-choice examination', 'PBL']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}]",175.0,0.0132945,"The students in the PBL group scored significantly higher on the posttraining multiple-choice examination, compared to the LBL group ( P  = 0.048).","[{'ForeName': 'Farzad Vaghef', 'Initials': 'FV', 'LastName': 'Davari', 'Affiliation': 'Sina Trauma and Surgery Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Teymouri', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, International Campus, Tehran, Iran.'}, {'ForeName': 'Hadi Ahmadi', 'Initials': 'HA', 'LastName': 'Amoli', 'Affiliation': 'Department of Surgery, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Helia', 'Initials': 'H', 'LastName': 'Mojtabavi', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amirsina', 'Initials': 'A', 'LastName': 'Sharifi', 'Affiliation': 'Sina Trauma and Surgery Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Alaeddini', 'Affiliation': 'Research Center for Health Management in Mass Gathering, Red Crescent Society of Islamic Republic of Iran, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ashouri', 'Affiliation': 'Department of Surgery, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Zabihi', 'Affiliation': 'Department of Surgery, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ghazal', 'Initials': 'G', 'LastName': 'Shariatpanahi', 'Affiliation': 'School of Medicine, Bahrami Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Zafarghandi', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, International Campus, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_266_21']
3043,35233416,Promotion of osteoporosis-preventive behaviors in adolescents: Application of protection motivation theory.,"BACKGROUND


Osteoporosis is considered a health problem that can be simply prevented by lifestyle modifications in adolescence. Therefore, this study was conducted to investigate the effects of protection motivation theory (PMT)-based training on osteoporosis-preventive behaviors in female high school students in Zahedan, Iran.
MATERIALS AND METHODS


The present quasi-experimental study was performed on 240 female high school students who were selected by a multistage sampling technique in Zahedan in 2019-2020. To collect the data, a multipart questionnaire was distributed among the participants in three stages, namely at the baseline, immediately, and 2 months after the intervention. This instrument consisted of demographic information, socioeconomic status, knowledge, PMT constructs, and preventive behaviors. The intervention group was subjected to educational content. The collected data were analyzed in SPSS software (version 22) by descriptive and analytical tests (i.e., Chi-square, independent  t -test, and ANOVA).
RESULTS


Based on the results, the intervention and control groups showed no significant difference in terms of the mean score of knowledge, theoretical constructs, and preventive behaviors at the baseline ( P  > 0.05). However, the two groups were significantly different in terms of the mentioned variables immediately and 2 months after the intervention ( P  = 0.001). Mean score of preventive behaviors, the two groups also demonstrated a significant difference (i.e., calcium intake, physical activity, and sunlight exposure) 2 months after the intervention, compared to before the intervention. ( P  = 0.001).
CONCLUSION


The findings of the present study were indicative of the PMT effectiveness, which can, therefore, be used as a framework for designing educational programs regarding osteoporosis prevention.",2021,"Based on the results, the intervention and control groups showed no significant difference in terms of the mean score of knowledge, theoretical constructs, and preventive behaviors at the baseline ( P  > 0.05).","['240 female high school students who were selected by a multistage sampling technique in Zahedan in 2019-2020', 'female high school students in Zahedan, Iran', 'adolescents']",['protection motivation theory (PMT)-based training'],"['calcium intake, physical activity, and sunlight exposure', 'Mean score of preventive behaviors', 'osteoporosis-preventive behaviors', 'mean score of knowledge, theoretical constructs, and preventive behaviors']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0497062', 'cui_str': '[X]Exposure to sunlight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}]",240.0,0.0318193,"Based on the results, the intervention and control groups showed no significant difference in terms of the mean score of knowledge, theoretical constructs, and preventive behaviors at the baseline ( P  > 0.05).","[{'ForeName': 'Somayyeh', 'Initials': 'S', 'LastName': 'Khazaeian', 'Affiliation': 'Department of Midwifery, Pregnancy Health Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Fariba Shahraki', 'Initials': 'FS', 'LastName': 'Sanavi', 'Affiliation': 'Health Promotion Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ansari', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Health Promotion Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mirshekari', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Zahedan University of Medical Sciences, Zahedan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_1515_20']
3044,35233770,Impact evaluation of the family expectations program and moderation by sociodemographic disadvantage.,"The federal government, through the Administration for Children and Families (ACF), has funded community-based relationship education programs for couples, individuals, and families, with a strong focus on serving economically disadvantaged and racially diverse families. This study evaluated the impact of a 36-hour, workshop-based couple relationship education program that was funded by ACF using a randomized controlled trial (RCT) design and intent-to-treat (ITT) analyses. Participants were 1320 couples who were either expecting a baby or had a baby within the past 3 months, at the time of enrollment. Follow-up surveys were administered 12 months later. Analyses evaluated program impacts on relationship stability, constructive communication, and destructive conflict compared to a no-treatment control group. Analyses showed a statistically significant impact of the program on destructive conflict (d = 0.10) but not on constructive communication (d = 0.06) or stability (d Cox   = 0.10). Based on findings from previous evaluations, we also examined whether participants' levels of sociodemographic disadvantage moderated these effects. There was significant moderation by sociodemographic disadvantage on constructive communication and destructive conflict, but not on stability. Effects were observed for those at higher levels of sociodemographic disadvantage.",2022,Analyses showed a statistically significant impact of the program on destructive conflict (d = 0.10) but not on constructive communication (d = 0.06) or stability (d Cox   = 0.10).,"['Participants were 1320 couples who were either expecting a baby or had a baby within the past 3\xa0months, at the time of enrollment']","['36-hour, workshop-based couple relationship education program']","['destructive conflict', 'relationship stability, constructive communication, and destructive conflict', 'constructive communication']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0233520', 'cui_str': 'Destructive behavior'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",1320.0,0.050526,Analyses showed a statistically significant impact of the program on destructive conflict (d = 0.10) but not on constructive communication (d = 0.06) or stability (d Cox   = 0.10).,"[{'ForeName': 'Lane L', 'Initials': 'LL', 'LastName': 'Ritchie', 'Affiliation': 'VA Greater Los Angeles Healthcare System, Los Angeles, California, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Stanley', 'Affiliation': 'Center for Marital and Family Studies, University of Denver, Denver, Colorado, USA.'}, {'ForeName': 'Maggie O T', 'Initials': 'MOT', 'LastName': 'Allen', 'Affiliation': 'Center for Marital and Family Studies, University of Denver, Denver, Colorado, USA.'}, {'ForeName': 'Galena K', 'Initials': 'GK', 'LastName': 'Rhoades', 'Affiliation': 'Center for Marital and Family Studies, University of Denver, Denver, Colorado, USA.'}]",Family process,['10.1111/famp.12762']
3045,35233755,"Cost-Effectiveness of Trastuzumab With or Without Chemotherapy as Adjuvant Therapy in HER2-Positive Elderly Breast Cancer Patients: A Randomized, Open-Label Clinical Trial, the RESPECT Trial.","BACKGROUND AND OBJECTIVE


Trastuzumab is a standard care as adjuvant chemotherapy (AdjCT) for patients with human epidermal growth factor receptor 2 (HER2)-positive primary breast cancer (BC) in Japan. However, no reports have evaluated its economics for patients with HER2-positive BC over 70 years of age. The objective of this study was to evaluate the cost-effectiveness of HER2-targeted trastuzumab + chemotherapy in Japan, comparing it with trastuzumab monotherapy.
METHODS


A three-state-partitioned survival model was developed to evaluate the cost-effectiveness of trastuzumab + chemotherapy versus trastuzumab monotherapy for AdjCT in elderly patients with HER2-positive BC. We derived the efficacy data, utilities, and costs of both arms from individual patient data in the RESPECT trial (NCT01104935) and published studies. The costs and quality-adjusted life years (QALYs) were discounted at 2% per annum using a payer perspective. The respective cost estimates were reported in 2019 Japanese Yen (JPY) or US dollars (US$). The primary outcome was the incremental cost-effectiveness ratio (ICER). We assured robustness with deterministic and probabilistic sensitivity analyses.
RESULTS


The cost per patient for trastuzumab + chemotherapy was JPY 14.6 million (US$137,000), and their QALYs were 9.308, compared with JPY 14.2 million (US$131,000) and 9.101, respectively, for trastuzumab monotherapy. The ICER of trastuzumab + chemotherapy versus trastuzumab monotherapy was JPY 2.7 milllion/QALY (US$17,200/QALY). The ICER for trastuzumab with chemotherapy varied from ""Dominant"" to ""Dominated"" in one-way sensitivity analysis.
CONCLUSIONS


The base-case analysis suggests that AdjCT with trastuzumab + chemotherapy is likely to be a cost-effective choice for patients with HER2-positive BC aged 70 years or older. However, the sensitivity analysis suggested uncertainty regarding the cost-effectiveness of trastuzumab + chemotherapy.",2022,"The ICER for trastuzumab with chemotherapy varied from ""Dominant"" to ""Dominated"" in one-way sensitivity analysis.
","['HER2-Positive Elderly Breast Cancer Patients', 'patients with human epidermal growth factor receptor 2 (HER2)-positive primary breast cancer (BC) in Japan', 'patients with HER2-positive BC aged 70 years or older', 'patients with HER2-positive BC over 70 years of age', 'elderly patients with HER2-positive BC']","['trastuzumab\xa0+\xa0chemotherapy', 'trastuzumab\u2009+\u2009chemotherapy', 'Trastuzumab', 'trastuzumab\xa0+\xa0chemotherapy versus trastuzumab monotherapy', 'Chemotherapy', 'HER2-targeted trastuzumab + chemotherapy', 'adjuvant chemotherapy (AdjCT']","['efficacy data, utilities, and costs', 'incremental cost-effectiveness ratio (ICER', 'costs and quality-adjusted life years (QALYs', 'cost-effectiveness']","[{'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.173788,"The ICER for trastuzumab with chemotherapy varied from ""Dominant"" to ""Dominated"" in one-way sensitivity analysis.
","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Takumoto', 'Affiliation': 'Department of Health and Welfare Services, Center for Outcomes Research and Economic Evaluation for Health, National Institute of Public Health, 2-3-6, Wako, Saitama, 351-0104, Japan. Takumoto.y.aa@gmail.com.'}, {'ForeName': 'Takeru', 'Initials': 'T', 'LastName': 'Shiroiwa', 'Affiliation': 'Department of Health and Welfare Services, Center for Outcomes Research and Economic Evaluation for Health, National Institute of Public Health, 2-3-6, Wako, Saitama, 351-0104, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Shimozuma', 'Affiliation': 'Department of Biomedical Sciences, College of Life Sciences, Ritsumeikan University, Kusatsu, Japan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Breast Surgery, NHO Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Baba', 'Affiliation': 'Department of Surgery, Sagara Hospital, Kagoshima, Japan.'}, {'ForeName': 'Kokoro', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Medical Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Hagiwara', 'Affiliation': 'Department of Biostatistics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Kawahara', 'Affiliation': 'Biostatistics Division, Clinical Research Promotion Center, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Biostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Naruto', 'Initials': 'N', 'LastName': 'Taira', 'Affiliation': 'Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Sawaki', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}]",Clinical drug investigation,['10.1007/s40261-022-01124-y']
3046,35233749,Improving Sleep Among Teachers: an Implementation-Intention Intervention.,"BACKGROUND


Insufficient sleep is common among teachers and is associated with diverse health risks. This study aimed to predict intention and sleep duration by applying the Theory of Planned Behavior (TPB) and to examine the effectiveness of an implementation-intention intervention to improve sleep duration and quality.
METHOD


Sixty-nine teachers (M = 36.8 years, SD = 10.4) were assigned to an active control group (CG) or intervention group (IG). At baseline, TPB variables were assessed and participants of the IG received instructions to develop implementation intentions to reach the goal of sleeping 8 h on average. During a 3-week intervention period, all participants wore an activity tracker (Fitbit Charge HR) to measure sleep duration and kept diaries to assess sleep quality, physical activity, and stress. After 1 month, a 1-week follow-up, including a booster for the IG, was conducted.
RESULTS


Forty-two percent of variance in sleep duration were explained by control variables, past behavior, perceived behavioral control, and intention. Mixed ANOVAS with baseline covariates found a large main effect with longer sleep duration in the IG. A time x group interaction suggested that only the IG slept significantly longer in the follow-up period compared to the intervention period. For sleep quality, a medium-sized main effect for study group was found and a time x group interaction indicated higher sleep quality in the IG for week 3 and the follow-up.
CONCLUSION


The TPB was effective in predicting sleep intention and duration. Implementation intentions accompanied by daily monitoring and a booster appear to be promising for improving sleep.",2022,x group interaction suggested that only the IG slept significantly longer in the follow-up period compared to the intervention period.,"['Sixty-nine teachers (M\u2009=\u200936.8\xa0years, SD\u2009=\u200910.4', 'Teachers']","['TPB', 'activity tracker (Fitbit Charge HR', 'active control group (CG) or intervention group (IG', 'implementation-intention intervention']","['sleep duration', 'sleep quality', 'sleep quality, physical activity, and stress', 'sleep duration and quality']","[{'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191376', 'cui_str': '10.4'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",69.0,0.0652933,x group interaction suggested that only the IG slept significantly longer in the follow-up period compared to the intervention period.,"[{'ForeName': 'Laura I', 'Initials': 'LI', 'LastName': 'Schmidt', 'Affiliation': 'Institute of Psychology, Department of Gender Studies and Health Psychology, University of Heidelberg, Heidelberg, Germany. Laura.Schmidt@psychologie.uni-heidelberg.de.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Steenbock', 'Affiliation': 'Institute of Psychology, Department of Gender Studies and Health Psychology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Sieverding', 'Affiliation': 'Institute of Psychology, Department of Gender Studies and Health Psychology, University of Heidelberg, Heidelberg, Germany.'}]",International journal of behavioral medicine,['10.1007/s12529-022-10069-7']
3047,35233748,Advancing combination treatment with glycyrrhizin and boswellic acids for hospitalized patients with moderate COVID-19 infection: a randomized clinical trial.,"Recent evidence points to a potential therapeutic role for glycyrrhizin(GR) and boswellic acids (BA) in the treatment of COVID-19 but conclusive evidence is lacking. Our aim is to investigate the efficacy of GR + BA versus placebo for the treatment of hospitalized patients with moderate SARS-CoV-2 or COVID-19 variants infection. The current study is a randomized, double-blind, placebo-controlled, single-center trial. Patients with SARS-CoV-2 or COVID-19 variants diagnosed by PCR test who were admitted to Sohag University hospital were eligible if they were at least 18 years of age and had moderate symptoms. Patients were randomly assigned to receive oral GR capsule (60 mg) and BA (200 mg) twice daily for 14 days or a matching placebo. All patients also received treatment with the institutional protocol for COVID-19. The primary outcome was mortality and time to recovery. Secondary outcome was clinical status score, 14 days after receiving study drugs. Adverse events from use of study drugs have been evaluated for up to 14 days. The trial is registered at ClinicalTrials.gov (Identifier NCT04487964). During the 6-month enrollment period (June-November, 2021) only 50 patients (54% women; median age 60 years, IQR 54-65) met eligibility and were randomly assigned. Evaluation of the primary outcome at 14 days showed that there were five deaths in the placebo group and no deaths in the GR + BA group. With regard to recovery time, it was significantly shorter (p = 0.0001) in the group receiving GR + BA capsule compared to the placebo group (median 7.0; IQR 6.0-8.0 days vs. median 12.5; IQR 12-20 days). Clinical status on the ordinal score scale as a secondary outcome showed a significant difference between the GR + BA group (median (IQR) score, 2 [2-3]) and placebo groups (mean (IQR) score, 3 [3-5.5]). There was a significant decrease in CRB (p = 0.000041) in GR + BA compared with the placebo group. In conclusion, this safe, inexpensive, antiviral, immunomodulating and anti-inflammatory combination may be considered for use in mild to moderate infections of SARS-CoV-2 or COVID-19 variants. The study is limited by the small sample size; therefore, larger randomized trials are required.",2022,"With regard to recovery time, it was significantly shorter (p = 0.0001) in the group receiving GR + BA capsule compared to the placebo group (median 7.0; IQR 6.0-8.0 days vs. median 12.5; IQR 12-20 days).","['hospitalized patients with moderate SARS-CoV-2 or COVID-19 variants infection', 'hospitalized patients with moderate COVID-19 infection', '50 patients (54% women; median age 60\xa0years, IQR 54-65) met eligibility', 'Patients with SARS-CoV-2 or COVID-19 variants diagnosed by PCR test who were admitted to Sohag University hospital were eligible if they were at least 18\xa0years of age and had moderate symptoms']","['GR\u2009+\u2009BA versus placebo', 'boswellic acids (BA', 'placebo', 'oral GR capsule (60\xa0mg) and BA', 'glycyrrhizin and boswellic acids']","['CRB', 'mortality and time to recovery']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0061751', 'cui_str': 'Glycyrrhizic Acid'}, {'cui': 'C0053959', 'cui_str': 'boswellic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C2931258', 'cui_str': 'Amaurosis congenita of Leber, type 1'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.593408,"With regard to recovery time, it was significantly shorter (p = 0.0001) in the group receiving GR + BA capsule compared to the placebo group (median 7.0; IQR 6.0-8.0 days vs. median 12.5; IQR 12-20 days).","[{'ForeName': 'Adel A', 'Initials': 'AA', 'LastName': 'Gomaa', 'Affiliation': 'Department of Medical Pharmacology, Faculty of Medicine, Assiut University, Assiut, Egypt. a.gomma@aun.edu.eg.'}, {'ForeName': 'Hamdy S', 'Initials': 'HS', 'LastName': 'Mohamed', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Rasha B', 'Initials': 'RB', 'LastName': 'Abd-Ellatief', 'Affiliation': 'Department of Medical Pharmacology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Gomaa', 'Affiliation': 'Department of Plastic Surgery, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Doaa S', 'Initials': 'DS', 'LastName': 'Hammam', 'Affiliation': 'Department of Pharmacology & Toxicology, Faculty of Pharmacy, Assiut University, Assiut, Egypt.'}]",Inflammopharmacology,['10.1007/s10787-022-00939-7']
3048,35237229,A Novel Endovascular Therapy Strategy for Acute Ischemic Stroke Due to Intracranial Atherosclerosis-Related Large Vessel Occlusion: Stent-Pass-Aspiration-resCuE-Micowire-Angioplasty (SPACEMAN) Technique.,"Background


There is no clear consensus on the optimal endovascular treatment strategy for patients with ischemic stroke caused by ICAS-related large vessel occlusion (LVO). SPACEMAN, a novel thrombectomy technique that entails passing an aspiration catheter over the stent retriever and then retaining the microwire for angioplasty, has not been described. The aim of this prospective study was to evaluate our initial application of SPACEMAN and compare this technique with the Solumbra technique.
Methods


Forty-four consecutive patients with acute ischemic stroke resulting from ICAS-related LVO were randomly divided into two groups: Solumbra group ( n  = 22) and SPACEMAN group ( n  = 22). Demographic and clinical data were prospectively collected. Modified Rankin Scale (mRS) score of ≤ 2 of anterior circulation and mRS score ≤ 3 of posterior circulation at 3 months post-discharge was regarded as good prognosis.
Results


The SPACEMAN group showed reduced mean time from femoral access to recanalization compared with the Solumbra group (39.55 ± 10.63 min vs. 50.73 ± 9.89 min,  P  = 0.001). The overall recanalization rate in the entire cohort was 93.18% (41/44). At 3-month follow-up, the overall good prognosis rate was 47.73%; 13 patients (59.09%) in the SPACEMAN group and 8 (36.36%) in the Solumbra group showed good prognosis. One patient in the SPACEMAN group (4.55%) and two patients in the Solumbra group (9.09%) developed symptomatic intracranial hemorrhage. The overall mortality rate was 4.55% (2/44).
Conclusions


This study suggests that SPACEMAN exhibits a shorter operation revascularization time than the standard thrombectomy. Complications and prognosis were comparable between the two groups. The safety and efficacy of this novel technique need to be studied in larger patient series.",2022,Complications and prognosis were comparable between the two groups.,"['Methods\n\n\nForty-four consecutive patients with acute ischemic stroke resulting from ICAS-related LVO', 'patients with ischemic stroke caused by ICAS-related large vessel occlusion (LVO', 'Acute Ischemic Stroke Due to Intracranial Atherosclerosis-Related Large Vessel Occlusion']",[],"['Modified Rankin Scale (mRS) score of ≤ 2 of anterior circulation and mRS score ≤ 3 of posterior circulation', 'operation revascularization time', 'overall good prognosis rate', 'mean time from femoral access to recanalization', 'overall recanalization rate', 'safety and efficacy', 'overall mortality rate', 'symptomatic intracranial hemorrhage']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0685889', 'cui_str': 'Hypoplasia of spleen'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0751007', 'cui_str': 'Intracranial Atherosclerosis'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}]",44.0,0.0308031,Complications and prognosis were comparable between the two groups.,"[{'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, ORDOS Central Hospital, Ordos, China.'}, {'ForeName': 'Junmei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, ORDOS Central Hospital, Ordos, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, ORDOS Central Hospital, Ordos, China.'}, {'ForeName': 'Guanqing', 'Initials': 'G', 'LastName': 'Feng', 'Affiliation': 'Department of Neurology, ORDOS Central Hospital, Ordos, China.'}, {'ForeName': 'Wenzhao', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, ORDOS Central Hospital, Ordos, China.'}, {'ForeName': 'Yuejiang', 'Initials': 'Y', 'LastName': 'Gui', 'Affiliation': 'Department of Neurology, ORDOS Central Hospital, Ordos, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Neurology, ORDOS Central Hospital, Ordos, China.'}]",Frontiers in neurology,['10.3389/fneur.2022.798542']
3049,35237700,Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir/Abacavir/Lamivudine in Antiretroviral-Naive Adults (SYMTRI): A Multicenter Randomized Open-Label Study (PReEC/RIS-57).,"Background


Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) is the reference for combination therapy based on protease inhibitors due to its efficacy, tolerability, and convenience. Head-to-head randomized comparisons between D/C/F/TAF and combination therapy based on integrase inhibitors in antiretroviral-naive patients are lacking.
Methods


Adult (>18 years old) human immunodeficiency virus-infected antiretroviral-naive patients (HLA-B∗5701 negative and hepatitis B virus negative), with viral load (VL) ≥500 c/mL, were centrally randomized to initiate D/C/F/TAF or dolutegravir/abacavir/lamivudine (DTG/3TC/ABC) after stratifying by VL and CD4 count. Clinical and analytical assessments were performed at weeks 0, 4, 12, 24, and 48. The primary endpoint was VL <50 c/mL at week 48 in the intention-to-treat (ITT)-exposed population (US Food and Drug Administration snapshot analysis, 10% noninferiority margin).
Results


Between September 2018 and 2019, 316 patients were randomized and 306 patients were included in the ITT-exposed analysis (151 D/C/F/TAF and 155 DTG/3TC/ABC). Almost all (94%) participants were male and their median age was 35 years. Forty percent had a baseline VL >100 000 copies/mL, and 13% had <200 CD4 cells/μL. Median weight was 73 kg and median body mass index was 24 kg/m 2 . At 48 weeks, 79% (D/C/F/TAF) versus 82% (DTG/3TC/ABC) had VL <50 c/mL (difference, -2.4%; 95% confidence interval [CI], -11.3 to 6.6). Eight percent versus four percent experienced virologic failure but no resistance-associated mutations emerged. Four percent versus six percent had drug discontinuation due to adverse events. In the per-protocol analysis, 94% versus 96% of patients had VL <50 c/mL (difference, -2%; 95% CI, -8.1 to 3.5). There were no differences in CD4 cell count or weight changes.
Conclusions


We could not demonstrate the noninferiority of D/C/F/TAF relative to DTG/ABC/3TC as initial antiretroviral therapy, although both regimens were similarly well tolerated.",2022,"(difference, -2.4%; 95% confidence interval [CI], -11.3 to 6.6).","['Almost all (94%) participants were male and their median age was 35 years', 'Results\n\n\nBetween September 2018 and 2019, 316 patients were randomized and 306 patients were included in the ITT-exposed analysis (151 D/C/F/TAF and 155 DTG/3TC/ABC', 'Methods\n\n\nAdult (>18 years old) human immunodeficiency virus-infected antiretroviral-naive patients (HLA-B∗5701 negative and hepatitis B virus negative), with viral load (VL', 'Antiretroviral-Naive Adults (SYMTRI']","['Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir/Abacavir/Lamivudine', 'TAF or dolutegravir/abacavir/lamivudine (DTG/3TC/ABC', '\n\n\nDarunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF']","['baseline VL', 'tolerated', 'virologic failure', 'CD4 cell count or weight changes', 'Median weight']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3871454', 'cui_str': 'darunavir and cobicistat'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine and tenofovir alafenamide'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]","[{'cui': 'C3871454', 'cui_str': 'darunavir and cobicistat'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine and tenofovir alafenamide'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1613391', 'cui_str': 'lamivudine and abacavir'}, {'cui': 'C1450557', 'cui_str': 'IGFBP7 protein, human'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",316.0,0.569623,"(difference, -2.4%; 95% confidence interval [CI], -11.3 to 6.6).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Podzamczer', 'Affiliation': 'Hospital Universitari de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Micán', 'Affiliation': 'Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tiraboschi', 'Affiliation': 'Hospital Universitari de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Portilla', 'Affiliation': 'Hospital General Universitario de Alicante, Alicante, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Domingo', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Llibre', 'Affiliation': 'Hospital Germans Trias i Pujol, Barcelona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ribera', 'Affiliation': ""Hospital Universitario de la Vall d'Hebrón, Barcelona, Spain.""}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Vivancos', 'Affiliation': 'Hospital Universitario Ramón y Cajal, Madrid, Universidad de Alcalá, IRYCIS, Madrid, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Morano', 'Affiliation': 'Hospital Universitario Álvaro Cunqueiro, Vigo, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Masiá', 'Affiliation': 'Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gómez', 'Affiliation': 'Hospital Universitario Virgen de la Victoria-IBIMA, Málaga, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Fanjul', 'Affiliation': 'Hospital Universitario Son Espases, Palma, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Payeras', 'Affiliation': 'Hospital Universitario Son Llàtzer, Palma, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Inciarte', 'Affiliation': 'Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Estrada', 'Affiliation': 'Hospital Clínico San Carlos-IdiSSC, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rivero', 'Affiliation': 'Hospital Universitario Reina Sofía, Córdoba, Spain.'}, {'ForeName': 'Á', 'Initials': 'Á', 'LastName': 'Castro', 'Affiliation': 'Complejo Hospitalario Universitario, A Coruña, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bernal', 'Affiliation': 'Hospital Universitario Reina Sofía, Murcia, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Vinuesa', 'Affiliation': 'Hospital Universitario Clínico San Cecilio, Granada, Spain.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Knobel', 'Affiliation': 'Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Troya', 'Affiliation': 'Hospital Universitario Infanta Leonor, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Macías', 'Affiliation': 'Hospital Universitario Virgen de Valme, Sevilla, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Montero', 'Affiliation': 'Hospital Universitari i Politècnic La Fe, Valencia, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sanz', 'Affiliation': 'Hospital Universitario de La Princesa, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Navarro-Alcaraz', 'Affiliation': 'Hospital Universitari de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caicedo', 'Affiliation': 'RIS Red de Investigación en SIDA, Madrid, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fernández', 'Affiliation': 'Hospital Universitari de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Martínez', 'Affiliation': 'Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Moreno', 'Affiliation': 'Hospital Universitario Ramón y Cajal, Madrid, Universidad de Alcalá, IRYCIS, Madrid, Spain.'}]",Open forum infectious diseases,['10.1093/ofid/ofab595']
3050,35237466,A Multi-step Approach to Adapting a Mind-Body Resiliency Intervention for Fear of Cancer Recurrence and Uncertainty in Survivorship (IN FOCUS).,"Background


For cancer survivors, there is a paucity of fear of recurrence (FOR) interventions that integrate empirically supported mind-body and psychological skills for managing FOR and are delivered in scalable formats.
Objective


To adapt an evidence-based resiliency intervention to address FOR among cancer survivors.
Methods


A multidisciplinary team of researchers, clinicians, and patient stakeholders followed an iterative intervention adaptation process (ORBIT). In Step 1, we sought to define key FOR management skills through a literature review and feedback from stakeholders. In Step 2, we integrated findings into a treatment manual and refined procedures for in-person delivery to groups of cancer survivors, defined as adults who had completed primary cancer treatment for non-metastatic cancer. In Step 3, we conducted a single arm trial to assess initial acceptability and change in FOR severity with 23 cancer survivors (N=4 intervention groups). In Step 4, we conducted additional qualitative interviews with 28 cancer survivors (N=6 focus groups stratified by FOR severity, N=15 individual interviews) to define adaptive and maladaptive strategies for coping with FOR and to identify preferences for delivery. In Step 5, we refined the treatment manual and procedures for testing in a future pilot randomized feasibility trial.
Results


We identified critical feedback using a combination of qualitative and quantitative methods. The single arm trial suggested preliminary feasibility and sustained reductions in FOR severity, yet need for refinement (i.e., eligibility, delivery modality), prompting additional qualitative interviews for further targeting. The resulting intervention (IN FOCUS) is comprised of virtual, synchronous, group-delivered sessions that offer an integrated approach to FOR management by teaching cognitive-behavioral techniques, meditation, relaxation training, adaptive health behaviors, and positive psychology skills. Sessions are targeted by applying skills to FOR and associated healthcare engagement.
Conclusions


IN FOCUS is a targeted intervention for teaching mind-body resiliency skills to groups of cancer survivors with elevated FOR. Next steps are testing feasibility in a pilot randomized trial.",2022,"The resulting intervention (IN FOCUS) is comprised of virtual, synchronous, group-delivered sessions that offer an integrated approach to FOR management by teaching cognitive-behavioral techniques, meditation, relaxation training, adaptive health behaviors, and positive psychology skills.","['23 cancer survivors (N=4 intervention groups', '28 cancer survivors (N=6 focus groups stratified by FOR severity, N=15 individual interviews', 'cancer survivors', 'adults who had completed primary cancer treatment for non-metastatic cancer']",[],[],"[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",[],[],28.0,0.0645461,"The resulting intervention (IN FOCUS) is comprised of virtual, synchronous, group-delivered sessions that offer an integrated approach to FOR management by teaching cognitive-behavioral techniques, meditation, relaxation training, adaptive health behaviors, and positive psychology skills.","[{'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Hall', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Conall', 'Initials': 'C', 'LastName': ""O'Cleirigh"", 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Peppercorn', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University and the Comprehensive Cancer Center of Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Denninger', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Bullock', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Mizrach', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Goshe', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Cheung', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Raissa', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Markowitz', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}]",Global advances in health and medicine,['10.1177/21649561221074690']
3051,35232596,"Safety and reactogenicity of a liquid formulation of human rotavirus vaccine (porcine circovirus-free): A phase III, observer-blind, randomized, multi-country study.","BACKGROUND


The introduction of rotavirus vaccines in national immunization programs has decreased mortality and hospitalizations due to diarrhea. GSK's live-attenuated, human rotavirus vaccine (HRV) is a 2-dose vaccine for oral administration. Following the detection of porcine circovirus type 1 (PCV-1) in HRV, a PCV-free (no detection of PCV-1 and PCV-2 according to the detection limits of tests used) HRV was developed. The immunogenicity, reactogenicity and safety of a liquid (liq) PCV-free HRV were assessed in two prior studies. The present study aimed to generate additional reactogenicity and safety data.
METHODS


This phase III, observer-blind, randomized, controlled multi-country study enrolled healthy 6-12-week-old infants. Infants were randomized to receive 2 doses of either the liq PCV-free HRV (N = 677) or the lyophilized (lyo) HRV (N = 674) 1-2 months apart. Solicited adverse events (AEs) were recorded for 8 days after each dose, unsolicited AEs for 31 days and serious AEs (SAEs) from dose 1 until the end of the 6-month safety follow-up.
RESULTS


The occurrence of solicited general AEs was comparable between the liq PCV-free HRV and the lyo HRV groups, with irritability/fussiness being the most frequently reported (74.9% [95% confidence interval: 71.4-78.1] and 72.1% [68.6-75.5]). Unsolicited AEs were reported for 29.7% (26.3-33.3) and 30.6% (27.1-34.2) of infants in the liq PCV-free HRV and the lyo HRV group. A total of 39 and 38 infants reported at least one SAE, respectively. The most common SAEs were upper respiratory tract (0.7% and 0.9%) and urinary tract infections (0.9% and 0.6%). One SAE (constipation) in the liq PCV-free HRV group was considered as potentially causally related to vaccination by the investigator. No deaths were reported.
CONCLUSIONS


The study showed that the reactogenicity and safety profiles of the liq PCV-free HRV and the lyo HRV are similar. ClinicalTrials.gov identifier: NCT0395474.",2022,"The occurrence of solicited general AEs was comparable between the liq PCV-free HRV and the lyo HRV groups, with irritability/fussiness being the most frequently reported (74.9% [95% confidence interval: 71.4-78.1] and 72.1% [68.6-75.5]).",['country study enrolled healthy 6-12-week-old infants'],"['liquid formulation of human rotavirus vaccine (porcine circovirus-free', 'liq PCV-free HRV (N\xa0=\xa0677) or the lyophilized (lyo) HRV (N\xa0=\xa0674', 'human rotavirus vaccine (HRV']","['Safety and reactogenicity', 'urinary tract infections', 'immunogenicity, reactogenicity and safety of a liquid (liq) PCV-free HRV', 'Unsolicited AEs', 'Solicited adverse events (AEs', 'reactogenicity and safety profiles', 'upper respiratory tract']","[{'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0318711', 'cui_str': 'Human rotavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0206411', 'cui_str': 'Porcine circovirus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0318711', 'cui_str': 'Human rotavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0458578', 'cui_str': 'Upper respiratory tract structure'}]",,0.286989,"The occurrence of solicited general AEs was comparable between the liq PCV-free HRV and the lyo HRV groups, with irritability/fussiness being the most frequently reported (74.9% [95% confidence interval: 71.4-78.1] and 72.1% [68.6-75.5]).","[{'ForeName': 'Yu-Lung', 'Initials': 'YL', 'LastName': 'Lau', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, The University of Hong Kong/Queen Mary Hospital, 102 Pokfulam Road, Pokfulam, Hong Kong Special Administrative Region. Electronic address: lauylung@hku.hk.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Fan Leung', 'Affiliation': 'Department of Paediatrics, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong. Electronic address: tfleung@cuhk.edu.hk.'}, {'ForeName': 'Benhur', 'Initials': 'B', 'LastName': 'Sirvan Cetin', 'Affiliation': 'Erciyes University, Faculty of Medicine, Department of Pediatrics, Pediatric Infectious Diseases Unit, 38030 Kayseri, Turkey. Electronic address: benhurcetin@yahoo.com.'}, {'ForeName': 'Ener', 'Initials': 'E', 'LastName': 'Cagri Dinleyici', 'Affiliation': 'Eskisehir Osmangazi University, Faculty of Medicine, Department of Pediatrics, TR-26040 Eskisehir, Turkey. Electronic address: enercagri@gmail.com.'}, {'ForeName': 'Li-Min', 'Initials': 'LM', 'LastName': 'Huang', 'Affiliation': 'National Taiwan University Hospital, Department of Pediatrics, No.8, Chung-Shan South Road, 100 Taipei, Taiwan. Electronic address: lmhuang@ntu.edu.tw.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Halperin', 'Affiliation': 'Canadian Center for Vaccinology, Dalhousie University, NS Health and IWK Health, 5850/5980 University Avenue, B3K 6R8 Halifax, Nova Scotia, Canada. Electronic address: scott.halperin@dal.ca.'}, {'ForeName': 'Chien-Chou', 'Initials': 'CC', 'LastName': 'Hsiao', 'Affiliation': 'Changhua Christian Hospital, 135 Nan-Hsiao Street, 500 Changhua, Taiwan. Electronic address: 68206@cch.org.tw.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Tapiero', 'Affiliation': 'CHU Sainte Justine , Université de Montréal, 3175 Chemin de la Côte-Sainte-Catherine, H3T 1C5 Montreal, Québec, Canada. Electronic address: bruce.tapiero.med@ssss.gouv.qc.ca.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Tipton', 'Affiliation': 'Copperview Medical Center, 3556 West 9800 South, 84095 South Jordan, UT, United States. Electronic address: tipton@rx-research.com.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Campbell', 'Affiliation': 'The University of Maryland School of Medicine, Department of Pediatrics, Division of Infectious Diseases and Tropical Pediatrics, Center for Vaccine Development and Global Health, 685 West Baltimore Street, HSF1 Room 480, Baltimore, MD 21201, United States. Electronic address: jcampbel@som.umaryland.edu.'}, {'ForeName': 'Leentje', 'Initials': 'L', 'LastName': 'Moerman', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: leentje.f.moerman@gsk.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Povey', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: michael.x.povey@gsk.com.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bi', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: dan.x.bi@gsk.com.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Singh', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: tina.x.singh@gsk.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2022.02.065']
3052,35232945,Impact of endotracheal tube taping site on tube displacement during head movements. A prospective randomised controlled study: Erratum.,,2022,,['tube displacement during head movements'],['endotracheal tube taping site'],[],"[{'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0376591', 'cui_str': 'Head Movements'}]","[{'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",[],,0.0137824,,[],European journal of anaesthesiology,['10.1097/EJA.0000000000001665']
3053,35232941,Effects of intra-operative end-tidal carbon dioxide levels on postoperative nausea and vomiting after thyroidectomy: A pilot randomised controlled study.,,2022,,['after thyroidectomy'],['intra-operative end-tidal carbon dioxide levels'],['postoperative nausea and vomiting'],"[{'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]",,0.132506,,"[{'ForeName': 'Wei-Jie', 'Initials': 'WJ', 'LastName': 'Feng', 'Affiliation': 'From the Department of Anaesthesiology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China (W-JF, B-CZ, HY, K-XL).'}, {'ForeName': 'Bing-Cheng', 'Initials': 'BC', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Ke-Xuan', 'Initials': 'KX', 'LastName': 'Liu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001604']
3054,35232905,Application of individualized nutrition support for adults with Stanford A aortic dissection.,"OBJECTIVES


Aortic dissection is a serious aortic pathological changes. Although the surgical technique for aortic dissection continues to improve, postoperative mortality and surgical complications are still high. This study aims to explore the effect of individualized nutritional support for the adult Stanford A aortic dissection.
METHODS


A total of 60 patients with Stanford A aortic dissection, who were treated in the Department of Cardiovascular Surgery at the First Affiliated Hospital of University of Science and Technology of China from January 2019 to February 2020, were selected. The subjects were divided into a control group ( n =29) and an observation group ( n =31) by random number table method. The control group received routine nutritional support, and the observation group received individualized nutritional support since the 1st day after surgery. The levels of serum nutritional indexes [albumin (Alb), prealbumin (PAB), hemoglobin (Hb), transferrin (TF)], immune function indexes [immunoglobulin G (IgG), immunoglobulin M (IgM), immunoglobulin A (IgA)], and inflammatory factors [tumor necrosis factor-α (TNF-α), interleukin-10 (IL-10), procalcitonin (PCT)] on the first day, the 5th day, and the 10th day after surgery were detected by Roche biochemical analyzer, immunoassay analyzer, and microplate reader, respectively. The acute physiology and chronic health evaluation II (APACHEII) was used to evaluate the prognosis on the first day, the 5th day, and the 10th day after surgery, and the incidence of complications was observed in the 2 groups.
RESULTS


There were significant differences between the 2 groups in Alb, PAB, Hb, TF, IgG, IgM, IgA, TNF-α, IL-10, and PCT (all  P <0.01), and there were also significant differences in the APACHEII, the time factor and the group factor (all  P <0.01). On the 5th day and the 10th day after surgery, the levels of Alb, PAB, Hb, TF, IgG, IgM and IgA were higher, and the levels of TNF-α and IL-10 while the scores of PCT and APACHEII were lower in the observation group than those in the control group (all  P <0.01). The incidence of complications in the observation group was significantly lower than that in the control group ( P <0.05).
CONCLUSIONS


For patients with Stanford A aortic dissection undergoing surgery, the postoperative individualized nutrition support can not only significantly improve nutritional level and immune function, but also effectively reduce levels of postoperative inflammatory factors, which is beneficial to their rapid recovery and has positive clinical significance for reducing postoperative complications and improving prognosis.",2021,"The incidence of complications in the observation group was significantly lower than that in the control group ( P <0.05).
","['patients with Stanford A aortic dissection undergoing surgery', '60 patients with Stanford A aortic dissection, who were treated in the Department of Cardiovascular Surgery at the First Affiliated Hospital of University of Science and Technology of China from January 2019 to February 2020, were selected', 'adults with Stanford A aortic dissection']","['individualized nutritional support', 'routine nutritional support, and the observation group received individualized nutritional support', 'individualized nutrition support']","['Alb, PAB, Hb, TF, IgG, IgM, IgA, TNF-α, IL-10, and PCT', 'levels of serum nutritional indexes [albumin (Alb), prealbumin (PAB), hemoglobin (Hb), transferrin (TF)], immune function indexes [immunoglobulin G (IgG), immunoglobulin M (IgM), immunoglobulin A (IgA)], and inflammatory factors [tumor necrosis factor-α (TNF-α', 'levels of TNF-α and IL-10 while the scores of PCT and APACHEII', 'interleukin-10 (IL-10), procalcitonin (PCT', 'nutritional level and immune function', 'postoperative mortality and surgical complications', 'incidence of complications', 'levels of Alb, PAB, Hb, TF, IgG, IgM and IgA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340643', 'cui_str': 'Dissection of aorta'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028710', 'cui_str': 'Nutrition Index'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",60.0,0.0558237,"The incidence of complications in the observation group was significantly lower than that in the control group ( P <0.05).
","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'School of Public Health, Anhui Medical University, Hefei 230032. 117936741@qq.com.'}, {'ForeName': 'Guangcun', 'Initials': 'G', 'LastName': 'Cheng', 'Affiliation': 'Department of Cardiovascular Surgery, First Affiliated Hospital of University of Science and Technology of China/Anhui Provincial Hospital, Hefei 230001, China. dhdhgdhagf@163.com.'}, {'ForeName': 'Yongjian', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'School of Public Health, Anhui Medical University, Hefei 230032.'}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2021.200874']
3055,35233731,Improved Confidence in a Confirmatory Stage by Application of Item-Based Pharmacometrics Model: Illustration with a Phase III Active Comparator-Controlled Trial in COPD Patients.,"PURPOSE


The current study aimed to illustrate how a non-linear mixed effect (NLME) model-based analysis may improve confidence in a Phase III trial through more precise estimates of the drug effect.
METHODS


The FULFIL clinical trial was a Phase III study that compared 24 weeks of once daily inhaled triple therapy with twice daily inhaled dual therapy in patients with chronic obstructive pulmonary disease (COPD). Patient reported outcome data, obtained by using The Evaluating Respiratory Symptoms in COPD (E-RS:COPD) questionnaire, from the FULFIL study were analyzed using an NLME item-based response theory model (IRT). The change from baseline (CFB) in E-RS:COPD total score over 4-week intervals for each treatment arm was obtained using the IRT and compared with published results obtained with a mixed model repeated measures (MMRM) analysis.
RESULTS


The IRT included a graded response model characterizing item parameters and a Weibull function combined with an offset function to describe the COPD symptoms-time course in patients receiving either triple therapy (n = 907) or dual therapy (n = 894). The IRT improved precision of the estimated drug effect compared to MMRM, resulting in a sample size of at least 3.64 times larger for the MMRM analysis to achieve the IRT precision in the CFB estimate.
CONCLUSION


This study shows the advantage of IRT over MMRM with a direct comparison of the same primary endpoint for the two analyses using the same observed clinical trial data, resulting in an increased confidence in Phase III.",2022,"The IRT improved precision of the estimated drug effect compared to MMRM, resulting in a sample size of at least 3.64 times larger for the MMRM analysis to achieve the IRT precision in the CFB estimate.
","['COPD Patients', 'patients receiving either triple therapy (n\u2009=\u2009907) or', 'patients with chronic obstructive pulmonary disease (COPD']","['inhaled triple therapy with twice daily inhaled dual therapy', 'dual therapy']","['Respiratory Symptoms in COPD (E-RS:COPD) questionnaire', 'change from baseline (CFB) in E-RS:COPD total score', 'IRT precision']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",,0.137355,"The IRT improved precision of the estimated drug effect compared to MMRM, resulting in a sample size of at least 3.64 times larger for the MMRM analysis to achieve the IRT precision in the CFB estimate.
","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Llanos-Paez', 'Affiliation': 'Department of Pharmacy, Uppsala University, BMC, Box 580, 751 23, Uppsala, Sweden.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Ambery', 'Affiliation': 'Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline plc, London, UK.'}, {'ForeName': 'Shuying', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline plc, London, UK.'}, {'ForeName': 'Misba', 'Initials': 'M', 'LastName': 'Beerahee', 'Affiliation': 'Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline plc, London, UK.'}, {'ForeName': 'Elodie L', 'Initials': 'EL', 'LastName': 'Plan', 'Affiliation': 'Department of Pharmacy, Uppsala University, BMC, Box 580, 751 23, Uppsala, Sweden.'}, {'ForeName': 'Mats O', 'Initials': 'MO', 'LastName': 'Karlsson', 'Affiliation': 'Department of Pharmacy, Uppsala University, BMC, Box 580, 751 23, Uppsala, Sweden. mats.karlsson@farmaci.uu.se.'}]",Pharmaceutical research,['10.1007/s11095-022-03194-1']
3056,35233724,The impact of lifestyle intervention on left atrial function in type 2 diabetes: results from the DIASTOLIC study.,"Aerobic exercise training and low energy diets have been shown to improve left ventricular remodelling and diastolic function in adults with type 2 diabetes (T2D), albeit with differential effects. The impact of these lifestyle interventions on left atrial (LA) function, however, has not previously been reported. The DIASTOLIC study was a prospective, randomised, open-label, blind endpoint trial, in which 90 people with obesity and T2D and no prevalent cardiovascular disease were randomised to a 12-week intervention of: (i) routine care, (ii) aerobic exercise training, or (iii) low energy (≈ 810 kcal/day) meal replacement plan (MRP). Cardiac magnetic resonance (CMR) imaging was performed pre- and post-intervention. Image analysis included LA volumes (LAV), emptying fraction (LAEF), and LA strain (LAS) corresponding to LA reservoir (LAS-r), conduit (LAS-cd), and booster pump (LAS-bp) function. 73 participants with T2D (mean age 50 ± 6 years, 62% male, body mass index (BMI) 36.1 ± 5.3 kg/m 2 ) completed the trial and had analysable LA images. There was no significant change in CMR measured LA volumetric function (LAV/LAEF) in any group. The routine care group showed no significant change in BMI or LAS. In the MRP group, there were significant reductions in BMI (4.5 kg/m 2 ) and a significant increase in LAS-r and LAS-bp (29.9 ± 7.0 to 32.3 ± 7.0%, p = 0.036 and 14.6 ± 5.3 to 17.2 ± 3.7%, p = 0.034). The exercise group showed a small reduction in BMI (0.49 kg/m 2 ), with no significant change in LAS. Compared to routine care, weight loss via a 12-week MRP, led to improvements in LA filling and contractile function in adults with T2D and obesity. However, these within-group changes were not statistically significant on between-group comparison. ClinicalTrials.gov Identifier: NCT02590822.",2022,"Compared to routine care, weight loss via a 12-week MRP, led to improvements in LA filling and contractile function in adults with T2D and obesity.","['73 participants with T2D (mean age 50\u2009±\u20096\xa0years, 62% male, body mass index (BMI) 36.1\u2009±\u20095.3\xa0kg/m 2 ) completed the trial and had analysable LA images', 'type 2 diabetes', '90 people with obesity and T2D and no prevalent cardiovascular disease', 'adults with type 2 diabetes (T2D', 'adults with T2D and obesity']","['Aerobic exercise training and low energy diets', 'lifestyle interventions', 'Cardiac magnetic resonance (CMR', 'routine care, (ii) aerobic exercise training, or (iii) low energy (≈ 810\xa0kcal/day) meal replacement plan (MRP', 'lifestyle intervention']","['LAS-r and LAS', 'BMI or LAS', 'LA volumes (LAV), emptying fraction (LAEF), and\xa0LA strain (LAS)\xa0corresponding to LA reservoir (LAS-r), conduit (LAS-cd), and booster pump (LAS-bp) function', 'CMR measured LA volumetric function (LAV/LAEF', 'BMI', 'left ventricular remodelling and diastolic function', 'small reduction in BMI', 'left atrial function', 'LAS', 'LA filling and contractile function', 'left atrial\xa0(LA) function']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0442537', 'cui_str': 'Reservoir'}, {'cui': 'C1562368', 'cui_str': 'Ligamentous articular strain technique'}, {'cui': 'C0441247', 'cui_str': 'Conduit'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0600519', 'cui_str': 'Ventricular remodelling'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0078995', 'cui_str': 'Left Atrial Function'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}]",73.0,0.0184764,"Compared to routine care, weight loss via a 12-week MRP, led to improvements in LA filling and contractile function in adults with T2D and obesity.","[{'ForeName': 'Aseel', 'Initials': 'A', 'LastName': 'Alfuhied', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Gaurav S', 'Initials': 'GS', 'LastName': 'Gulsin', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Athithan', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Emer M', 'Initials': 'EM', 'LastName': 'Brady', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Parke', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Henson', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Redman', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Anna-Marie', 'Initials': 'AM', 'LastName': 'Marsh', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, NIHR Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Gerry P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Anvesha', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK. as707@leicester.ac.uk.'}]",The international journal of cardiovascular imaging,['10.1007/s10554-022-02578-z']
3057,35233709,The impact of a multicomponent-functional training with postural correction on functional balance in the elderly with a history of falling.,"PURPOSE


Good posture plays a significant role for the elderly in achieving optimal quality of life. This study aimed to evaluate the impact of multicomponent functional training with postural correction on functional balance in the elderly with a history of falling.
METHODS


This study was a randomized controlled, single-blind study. Subjects (n = 28, mean age = 70 years) with a history of falling were selected and randomly allocated to either a multicomponent functional training (n = 14) or a control group (n = 14). The experimental group exercised for 8 weeks, three days per week for 60 min per day. The training program with strength, endurance, and balance parts was conducted in the multi-task conditions to stimulate the physical and cognitive abilities focusing on the attentional-correct posture. The control group received conventional care. The Berg balance and short physical performance battery tests were used in the pre-test and post-test. The adjusted post-test means of experimental and control groups were analyzed using the ANCOVA test to eliminate any pretest effects.
RESULTS


This study found a significant effect of training on Berg balance test (P = 0.001), Timed Up and Go with D-T (P = 0.01), Timed Up and Go (P = 0.002), and Short Physical Performance Battery (P = 0.001).
CONCLUSIONS


Eight weeks of multicomponent exercise training has beneficial effects on balance and physical function and results in improved equilibrium and a decreasing probability of falling. Therefore, practitioners can use this 8-week training program for older adults.",2022,"This study found a significant effect of training on Berg balance test (P = 0.001), Timed Up and Go with D-T (P = 0.01), Timed Up and Go (P = 0.002), and Short Physical Performance Battery (P = 0.001).
","['70\xa0years) with a history of falling', 'elderly with a history of falling', '28, mean age\u2009', 'Subjects (n\u2009', 'older adults']","['multicomponent-functional training with postural correction', 'multicomponent functional training with postural correction', 'multicomponent functional training', 'multicomponent exercise training', 'conventional care']","['Short Physical Performance Battery', 'Timed Up and Go with D-T', 'functional balance', 'balance and physical function']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.00485572,"This study found a significant effect of training on Berg balance test (P = 0.001), Timed Up and Go with D-T (P = 0.01), Timed Up and Go (P = 0.002), and Short Physical Performance Battery (P = 0.001).
","[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Sedaghati', 'Affiliation': 'Department of Sports Injuries and Corrective Exercise, Faculty of Physical Education and Sport Sciences, University of Guilan, Rasht, IR, Iran. sedaghati@guilan.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Goudarzian', 'Affiliation': 'Iranian Research Center On Healthy Aging, Sabzevar University of Medical Sciences, Sabzevar, IR, Iran. goudarzianmaryam@gmail.com.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Ahmadabadi', 'Affiliation': 'Department of Physical Education and Sports Sciences, Farhangian University, Tehran, IR, Iran.'}, {'ForeName': 'Seyed Mojtaba', 'Initials': 'SM', 'LastName': 'Tabatabai-Asl', 'Affiliation': 'Department of Sports Injuries and Corrective Exercise, Faculty of Physical Education and Sport Sciences, University of Guilan, Rasht, IR, Iran.'}]",Journal of experimental orthopaedics,['10.1186/s40634-022-00459-x']
3058,35233704,Influence of sodium hypochlorite concentration on cavitation effect and fluid dynamics induced by photon-induced photoacoustic streaming (PIPS): A visualization study.,"PURPOSE


The aim of the present study was to visualize and compare the cavitation effect and fluid dynamics induced by photon-induced photoacoustic streaming (PIPS) using sodium hypochlorite (NaOCl) with different concentrations as irrigant.
METHODS


Forty artificial root canals were prepared using MTWO Niti file up to size #25/.06. The canals were randomly divided into four groups (n = 10/group). High-speed camera was used to visualize and compare the cavitation effect induced by PIPS in the artificial root canals containing saline or NaOCl. Fluid velocity and Reynolds number of saline, 1%-, 2.5%- and 5.25% NaOCl irrigants induced by PIPS in the apical region were calculated using TEMA 2D software while the fluid motions were recorded.
RESULTS


Visualization profile revealed that NaOCl presented a stronger cavitation effect and fluid dynamics than saline during PIPS activation. In the apical region, 1% NaOCl group presented the highest average velocity of 3.868 m/s, followed by 2.5% NaOCl group (3.685 m/s), 5.25% NaOCl group (2.353 m/s) and saline group (1.268 m/s), corresponding to Reynolds number of 1653.173, 1572.196, 995.503 and 477.692. Statistically higher fluid velocity was calculated in 1% and 2.5% NaOCl groups compared to saline group, respectively (p < 0.05).
CONCLUSIONS


The application of NaOCl and its concentration significantly influence the cavitation effect and fluid dynamics during PIPS activation. 1% and 2.5% NaOCl groups presented a more violent fluid motion in the apical region when activated by PIPS.",2022,"Statistically higher fluid velocity was calculated in 1% and 2.5% NaOCl groups compared to saline group, respectively (p < 0.05).
","['Forty artificial root canals', 'photoacoustic streaming (PIPS']","['photon-induced photoacoustic streaming (PIPS) using sodium hypochlorite (NaOCl', 'sodium hypochlorite concentration']","['violent fluid motion', 'highest average velocity', 'fluid velocity']","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",40.0,0.0548343,"Statistically higher fluid velocity was calculated in 1% and 2.5% NaOCl groups compared to saline group, respectively (p < 0.05).
","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Cai', 'Affiliation': 'Department of Endodontics, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangdong Engineering Research Center of Oral Restoration and Reconstruction, Guangzhou Key Laboratory of Basic and Applied Research of Oral Regenerative Medical, Guangzhou, 510182, Guangdong, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': ""Department of Stomatology, The Third Affiliated Hospital of Shenzhen University, Shenzhen Luohu Hospital Group Luohu People's Hospital, Shenzhen, 518001, Guangdong, China.""}, {'ForeName': 'Lanxi', 'Initials': 'L', 'LastName': 'Guan', 'Affiliation': 'Department of Endodontics, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangdong Engineering Research Center of Oral Restoration and Reconstruction, Guangzhou Key Laboratory of Basic and Applied Research of Oral Regenerative Medical, Guangzhou, 510182, Guangdong, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Endodontics, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangdong Engineering Research Center of Oral Restoration and Reconstruction, Guangzhou Key Laboratory of Basic and Applied Research of Oral Regenerative Medical, Guangzhou, 510182, Guangdong, China. 1194394844@qq.com.'}, {'ForeName': 'Qianzhou', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of Endodontics, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangdong Engineering Research Center of Oral Restoration and Reconstruction, Guangzhou Key Laboratory of Basic and Applied Research of Oral Regenerative Medical, Guangzhou, 510182, Guangdong, China. jqianzhou@126.com.'}]",Lasers in medical science,['10.1007/s10103-022-03535-x']
3059,35233908,The differential effects of ertugliflozin on glucosuria and natriuresis biomarkers: Prespecified analyses from VERTIS CV.,"AIMS


Prespecified exploratory analyses from VERTIS CV (NCT01986881) assessed effects of the SGLT2 inhibitor ertugliflozin on glucosuria-related (HbA1c, uric acid [UA], body weight) and natriuresis-related (BP, haemoglobin, haematocrit, serum albumin) biomarkers by kidney function risk categories.
MATERIALS AND METHODS


Patients with T2DM and ASCVD were randomized to placebo, ertugliflozin 5 mg, or ertugliflozin 15 mg (1:1:1). Analyses compared placebo (n=2747) vs ertugliflozin (pooled; n=5499) on glucosuria- and natriuresis-related biomarkers by baseline eGFR subgroups and Kidney Disease: Improving Global Outcomes in CKD (KDIGO CKD) risk categories.
RESULTS


Patients were classified by KDIGO CKD low- (49%), moderate- (32%) and high/very high-risk categories (19%), and eGFR G stages 1 (25%), 2 (53%) and 3 (19%). At week 18, the high/very high-risk category had a smaller placebo-subtracted LSM change from baseline (95% CI) in HbA1c (-0.34 [-0.43, -0.25]) compared with low- and moderate-risk categories (-0.54 [-0.60, -0.49] and -0.47 [-0.54, -0.40], respectively). This pattern was maintained throughout the study (P interaction  =0.0001). Similar patterns by baseline eGFR G stages were observed. Placebo-subtracted LSM changes from baseline in UA were lowest in the high/very high-risk category at weeks 6 and 18, but the pattern was not maintained after week 156 (P interaction  =0.15). Effects of ertugliflozin on body weight and natriuresis-related biomarkers did not differ across KDIGO CKD categories.
CONCLUSIONS


In VERTIS CV, ertugliflozin was associated with physiologically favourable changes in glucosuria- and natriuresis-related biomarkers. Glycaemic efficacy of ertugliflozin was attenuated in patients with higher CKD risk. Effects on other biomarkers were consistent, regardless of CKD risk stage. This article is protected by copyright. All rights reserved.",2022,"Effects of ertugliflozin on body weight and natriuresis-related biomarkers did not differ across KDIGO CKD categories.
","['patients with higher CKD risk', 'Patients with T2DM']","['placebo', 'Placebo', 'ertugliflozin', 'placebo, ertugliflozin 5 mg, or ertugliflozin', 'SGLT2 inhibitor ertugliflozin']","['glucosuria-related (HbA1c, uric acid [UA], body weight) and natriuresis-related (BP, haemoglobin, haematocrit, serum albumin) biomarkers', 'body weight and natriuresis-related biomarkers', 'Glycaemic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C4535679', 'cui_str': 'ertugliflozin 5 MG'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}]","[{'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0027477', 'cui_str': 'Natriuresis'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.154325,"Effects of ertugliflozin on body weight and natriuresis-related biomarkers did not differ across KDIGO CKD categories.
","[{'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cosentino', 'Affiliation': 'Unit of Cardiology, Karolinska Institute & Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frederich', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Maldonado', 'Affiliation': 'MSD Limited, London, UK.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Chih-Chin', 'Initials': 'CC', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.14677']
3060,35233880,A psycho-oncological online intervention supporting partners of patients with cancer (PartnerCARE): Results from a randomized controlled feasibility trial.,"OBJECTIVE


Partners of cancer patients are the primary supporters and burdened at the same time. Support for partners is hitherto scarce and existing offers are rarely used. The PartnerCARE online intervention was specifically developed to address the caregiving partners' needs. This two-arm parallel randomized controlled trial evaluates the feasibility, acceptability, and potential efficacy of PartnerCARE.
METHODS


Sixty German-speaking partners of patients with various cancer entities were randomized into two conditions: intervention group with PartnerCARE (N=30) or waitlist-control group (N=30). Participants completed online questionnaires at baseline (T0), post-treatment (T1) and four-months follow-up (T2). Feasibility and acceptability outcomes included dropout rates, use and acceptance of PartnerCARE, individual user/e-coach feedback as well as negative effects. Relevant efficacy outcomes were assessed to test for potential intervention effects.
RESULTS


Recruitment success illustrates demand for and acceptability of PartnerCARE. Satisfaction with the intervention was high (CSQ-I, T1: M=24.66, SD=6.42) and 73.3 % of participants completed the intervention. Study dropout rate was low (T1: 17%, T2: 29%). More positive than negative side effects of the intervention were identified, and negative ones were mainly related to 'intrapersonal change'. For efficacy outcomes we found effects over time, with strongest effects within the intervention group from T0 to T1 in psychological distress (d=0.73, 95%-CI: [0.34; 1.12]) and anxiety (0.66, [0.26; 1.04]), but no group effects were significant at T1 and T2.
CONCLUSIONS


PartnerCARE is feasible, acceptable and potentially efficacious. Based on received feedback, PartnerCARE is currently undergoing further development and subsequently efficacy will be investigated in a randomized controlled trial. This article is protected by copyright. All rights reserved.",2022,"For efficacy outcomes we found effects over time, with strongest effects within the intervention group from T0 to T1 in psychological distress (d=0.73, 95%-CI: [0.34; 1.12]) and anxiety (0.66, [0.26; 1.04]), but no group effects were significant at T1 and T2.
","['Partners of cancer patients', 'Sixty German-speaking partners of patients with various cancer entities', 'patients with cancer (PartnerCARE']","['psycho-oncological online intervention', 'waitlist-control group', 'PartnerCARE']","['psychological distress', 'Study dropout rate', 'dropout rates, use and acceptance of PartnerCARE, individual user/e-coach feedback as well as negative effects', 'anxiety']","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",60.0,0.0810438,"For efficacy outcomes we found effects over time, with strongest effects within the intervention group from T0 to T1 in psychological distress (d=0.73, 95%-CI: [0.34; 1.12]) and anxiety (0.66, [0.26; 1.04]), but no group effects were significant at T1 and T2.
","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bodschwinna', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Ulm, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Lorenz', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Ulm, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bauereiß', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Gündel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Ulm, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hönig', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Ulm, Germany.'}]",Psycho-oncology,['10.1002/pon.5917']
3061,35233820,Preoperative Ultrasound-Guided Incisional Biopsy Enhances the Pathological Accuracy of Incisional Biopsy of Cutaneous Melanoma: A Prospective Clinical Trial in Chinese Patients.,"OBJECTIVES


To assess the feasibility of preoperative ultrasound (US)-guided incisional biopsy through a prospective controlled clinical trial.
METHODS


This was a prospective, double-arm, single-center study of Chinese patients. Thirty patients were enrolled in the study. Fourteen patients received incisional biopsies for which the choice of biopsy area relied on a clinical evaluation, and 16 patients received incisional biopsies for which the choice of biopsy area relied on a US-guided evaluation. The following procedure was used in the US-guided incisional biopsy group: 1) clinical and dermoscopic evaluation of skin lesions; 2) US examination; 3) incisional biopsy; 4) surgical excision; and 5) histopathological examination. The same procedure was used in the non-US-guided group except without US examination.
RESULTS


In the non-US-guided group, the mean tumor thicknesses obtained from incisional biopsy and postoperative histopathological examination were 2.1 and 4.1 mm, respectively. Seven melanomas were underestimated by incisional biopsy, resulting in margins narrower than currently recommended. In the US-guided group, the mean tumor thicknesses obtained from US, incisional biopsy, and postoperative histopathological examination were 3.4, 2.9, and 2.7 mm, respectively. In only 3 melanomas was the tumor thickness of the incisional biopsy less than that of the postoperative histopathological examination, demonstrating that US-guided biopsy obtains the maximum thickness area.
CONCLUSIONS


Preoperative US-guided incisional biopsy can enhance the pathological accuracy of incisional biopsy, which may allow us to better perform surgical excision with safe peripheral surgical margins.",2022,"In only 3 melanomas was the tumor thickness of the incisional biopsy less than that of the postoperative histopathological examination, demonstrating that US-guided biopsy obtains the maximum thickness area.
","['Chinese patients', 'Chinese Patients', 'Thirty patients were enrolled in the study', 'Fourteen patients received', 'Cutaneous Melanoma']","['Preoperative Ultrasound-Guided Incisional Biopsy', 'incisional biopsies', 'incisional biopsy; 4) surgical excision; and 5) histopathological examination', 'preoperative ultrasound (US)-guided incisional biopsy']","['mean tumor thicknesses obtained from US, incisional biopsy, and postoperative histopathological examination', 'mean tumor thicknesses obtained from incisional biopsy and postoperative histopathological examination']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184922', 'cui_str': 'Incisional biopsy - action'}, {'cui': 'C0728940', 'cui_str': 'Excision'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0184922', 'cui_str': 'Incisional biopsy - action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",30.0,0.0410406,"In only 3 melanomas was the tumor thickness of the incisional biopsy less than that of the postoperative histopathological examination, demonstrating that US-guided biopsy obtains the maximum thickness area.
","[{'ForeName': 'Nianzhou', 'Initials': 'N', 'LastName': 'Yu', 'Affiliation': 'Hunan Engineering Research Center of Skin Health and Disease, Changsha, China.'}, {'ForeName': 'Lisha', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Hunan Engineering Research Center of Skin Health and Disease, Changsha, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': 'Hunan Engineering Research Center of Skin Health and Disease, Changsha, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': 'Hunan Engineering Research Center of Skin Health and Disease, Changsha, China.'}, {'ForeName': 'Siliang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Hunan Engineering Research Center of Skin Health and Disease, Changsha, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Hunan Engineering Research Center of Skin Health and Disease, Changsha, China.'}, {'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Zixi', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Changsha, Hunan, China.'}, {'ForeName': 'Aojie', 'Initials': 'A', 'LastName': 'Zheng', 'Affiliation': 'Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Zirui', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Liao', 'Affiliation': 'Hunan Engineering Research Center of Skin Health and Disease, Changsha, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Hunan Engineering Research Center of Skin Health and Disease, Changsha, China.'}, {'ForeName': 'Tianhong', 'Initials': 'T', 'LastName': 'Wei', 'Affiliation': 'National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Changsha, Hunan, China.'}]",Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine,['10.1002/jum.15972']
3062,35234561,Pain relief and pain intensity response to GLP-1 receptor agonist ROSE-010 in irritable bowel syndrome; clinical study cross-analysis with respect to patient characteristics.,"BACKGROUND AND AIMS


Glucagon-like peptide-1 receptor agonist ROSE-010 has been studied for management of irritable bowel syndrome (IBS). ROSE-010 showed promising effects by reducing pain during attacks of IBS. In this exploratory substudy, we cross-analyzed earlier data to identify the most suitable subpopulation for treatment with ROSE-010.
METHODS


Data comprising 166 participants (116 females, 50 males) treated by subcutaneous injection with ROSE-010 at 100 µg and 300 µg versus placebo were broken down into subpopulations with recall of historical pain intensity, pain intensity immediately before treatment, gender, age, BMI, IBS subtype as well as pain intensity and pain relief of ROSE-010 with relationship to plasma glucose using visual analogue scores. Statistical cross-analysis was performed to detect optimal responders for adequate pain relief response.
RESULTS


ROSE-010 gave dose- and time-dependent effects with maximum pain relief at 300 µg relative 100 µg and placebo at 120 min post injection. Females had greater pain relief than males; age and BMI did not affect treatment response. IBS pain relief was greatest in constipation-dominant IBS (IBS-C) and mixed IBS (IBS-M) relative diarrhea-dominant and unspecified IBS.
CONCLUSIONS


Clinical trial data indicate that female participants are more likely than males to respond to ROSE-010 100 µg and 300 µg to achieve meaningful IBS pain relief. Maximum pain relief was achieved at 120 min with the higher dose, although this was accompanied with higher rates of nausea. Improvement of IBS pain attacks was most pronounced in IBS-C and IBS-M, suggesting these subgroups to be optimal ROSE-010 responders.",2022,"IBS pain relief was greatest in constipation-dominant IBS (IBS-C) and mixed IBS (IBS-M) relative diarrhea-dominant and unspecified IBS.
","['irritable bowel syndrome', 'Data comprising 166 participants (116 females, 50 males) treated by', 'female participants']","['GLP-1 receptor agonist ROSE-010', 'subcutaneous injection with ROSE-010 at 100\u2009µg and 300\u2009µg versus placebo', 'placebo', 'ROSE-010']","['maximum pain relief', 'Maximum pain relief', 'nausea', 'pain relief', 'pain intensity and pain relief of ROSE-010 with relationship to plasma glucose using visual analogue scores', 'IBS pain relief', 'meaningful IBS pain relief', 'Pain relief and pain intensity response', 'IBS pain attacks', 'pain during attacks of IBS']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C3501342', 'cui_str': 'ROSE-010'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3501342', 'cui_str': 'ROSE-010'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",166.0,0.126355,"IBS pain relief was greatest in constipation-dominant IBS (IBS-C) and mixed IBS (IBS-M) relative diarrhea-dominant and unspecified IBS.
","[{'ForeName': 'Aya A', 'Initials': 'AA', 'LastName': 'Touny', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Enda', 'Initials': 'E', 'LastName': 'Kenny', 'Affiliation': 'NV Rose, Hamilton, Bermuda.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Månsson', 'Affiliation': 'Amano Clinical Consulting, Sollentuna, Sweden.'}, {'ForeName': 'Dominic-Luc', 'Initials': 'DL', 'LastName': 'Webb', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Per M', 'Initials': 'PM', 'LastName': 'Hellström', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2022.2041084']
3063,35234819,Do Not Rule Out Double-blind Placebo Run-in Periods for Randomized Clinical Trials-Reply.,,2022,,[],['Placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.762675,,"[{'ForeName': 'Amelia J', 'Initials': 'AJ', 'LastName': 'Scott', 'Affiliation': 'School of Psychology, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Sharpe', 'Affiliation': 'School of Psychology, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Colagiuri', 'Affiliation': 'School of Psychology, University of Sydney, Sydney, New South Wales, Australia.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2022.0045']
3064,35234732,Clinical and Radiographic Comparison of Splinting Constructs for Distal Radius Fractures: an Effort to Free the Elbow.,"OBJECTIVES


To compare short term functional outcomes, reduction loss, and rates of surgery for distal radius fractures initially immobilized with a traditional sugartong splint vs clamshell splint freeing the elbow.
DESIGN


Prospective Randomized Trial.
SETTING


Level 1 Trauma Center.
PATIENTS


Eighty-nine consecutive patients sustaining distal radius fractures were enrolled between 2018 and 2020. Short term first follow up (1-2 weeks) radiographic parameters and 6 weeks for functional questionnaires were established to assess initial outcomes.
MAIN OUTCOME MEASURES


Reduction loss based on radiographic criteria, rate of surgery, short term patient functional outcome using the DASH score.
RESULTS


There were no differences noted in DASH scores (p-value=0.8) or loss of reduction (p-value=0.69) and splint type was not correlated with likelihood to have surgery (p=0.22). A binomial regression model demonstrated splint type was not a significant predictor variable of loss of fracture reduction in the regression model.
CONCLUSIONS


These results suggest both sugartong splint and clamshell splint construct are acceptable options in the acute management of distal radius fractures.
LEVEL OF EVIDENCE


Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.",2022,There were no differences noted in DASH scores (p-value=0.8) or loss of reduction (p-value=0.69) and splint type was not correlated with likelihood to have surgery (p=0.22).,"['Eighty-nine consecutive patients sustaining distal radius fractures were enrolled between 2018 and 2020', 'Distal Radius Fractures', 'Level 1 Trauma Center']","['traditional sugartong splint vs clamshell splint', 'sugartong splint and clamshell splint']","['DASH scores', 'fracture reduction', 'Reduction loss based on radiographic criteria, rate of surgery, short term patient functional outcome using the DASH score']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0038009', 'cui_str': 'Splint'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016641', 'cui_str': 'Fixation of fracture'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",89.0,0.0548,There were no differences noted in DASH scores (p-value=0.8) or loss of reduction (p-value=0.69) and splint type was not correlated with likelihood to have surgery (p=0.22).,"[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Stevens', 'Affiliation': 'NYU Langone Orthopedic Hospital, New York, N.Y., USA 10003.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pean', 'Affiliation': ''}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Norris', 'Affiliation': ''}, {'ForeName': 'Nirmal', 'Initials': 'N', 'LastName': 'Tejwani', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000002366']
3065,35234730,Unreamed Intramedullary Nailing Versus External Fixation for the Treatment of Open Tibial Shaft Fractures in Uganda: A Randomized Clinical Trial.,"OBJECTIVE


To compare unreamed intramedullary nailing versus external fixation for the treatment of Gustilo-Anderson type II and IIIA open tibial fractures admitted to a hospital in rural Uganda.
DESIGN


Randomized clinical trial.
SETTING


Regional referral hospital in Uganda.
PATIENTS


Fifty-five skeletally mature patients with a Gustilo-Anderson type II or IIIA open tibia shaft fracture treated within 24 hours of injury between May 2016 and December 2019.
INTERVENTION


Unreamed intramedullary nailing (n = 31) versus external fixation (n = 24).
MAIN OUTCOME MEASUREMENTS


The primary outcome was function within 12 months of injury, measured using the Function IndeX for Trauma (FIX-IT) score. Secondary outcomes included health-related quality of life (HRQoL) using the EQ-5D-3L, radiographic healing using the Radiographic Union Scale for Tibia (RUST) fractures score, and clinical complications.
RESULTS


Treatment with an intramedullary nail resulted in a 1.0 point higher (95% CrI, 0.1 to 1.9) FIX-IT score compared to external fixation. Results were similar for the secondary patient-reported outcomes, EQ-5D-3L and EQ-VAS. RUST scores were not different between groups at any time point. Treatment with an intramedullary nail was associated with a 22.1% (95% CrI -42.6% to 1.7%) lower rate of malunion and a 20.8% (95% CrI -44.0% to 2.9%) lower rate of superficial infection.
CONCLUSION


In rural Uganda, treatment of open tibial shaft fractures with an unreamed intramedullary nail results in marginal clinically important improvements in functional outcomes, though there is likely an important reduction in malunion and superficial infection.
LEVEL OF EVIDENCE


Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2022,"In rural Uganda, treatment of open tibial shaft fractures with an unreamed intramedullary nail results in marginal clinically important improvements in functional outcomes, though there is likely an important reduction in malunion and superficial infection.
","['Open Tibial Shaft Fractures in Uganda', 'Regional referral hospital in Uganda', 'Gustilo-Anderson type II and IIIA open tibial fractures admitted to a hospital in rural Uganda', 'Fifty-five skeletally mature patients with a Gustilo-Anderson type II or IIIA open tibia shaft fracture treated within 24 hours of injury between May 2016 and December 2019']","['external fixation', 'unreamed intramedullary nail', 'unreamed intramedullary nailing versus external fixation', 'Unreamed Intramedullary Nailing Versus External Fixation', 'Unreamed intramedullary nailing']","['health-related quality of life (HRQoL) using the EQ-5D-3L, radiographic healing using the Radiographic Union Scale for Tibia', 'FIX-IT score', 'RUST scores', 'rate of malunion', 'rate of superficial infection', 'RUST) fractures score, and clinical complications', 'EQ-5D-3L and EQ-VAS', 'function within 12 months of injury, measured using the Function IndeX for Trauma (FIX-IT) score']","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0588199', 'cui_str': 'Bone structure of shaft of tibia'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]",,0.0936122,"In rural Uganda, treatment of open tibial shaft fractures with an unreamed intramedullary nail results in marginal clinically important improvements in functional outcomes, though there is likely an important reduction in malunion and superficial infection.
","[{'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Kyengera', 'Affiliation': 'Department of Orthopaedics, Mbarara University of Science and Technology, Mbarara, Uganda University of Maryland School of Medicine, Baltimore, Maryland Department of Orthopaedics, University of British Columbia, Vancouver, British Columbia.'}, {'ForeName': 'Nathan N', 'Initials': 'NN', 'LastName': ""O'Hara"", 'Affiliation': ''}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': ''}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Howe', 'Affiliation': ''}, {'ForeName': 'Piotr A', 'Initials': 'PA', 'LastName': 'Blachut', 'Affiliation': ''}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Brien"", 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stockton', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000002362']
3066,35234658,Supporting Behavior Change in Sedentary Adults via Real-time Multidimensional Physical Activity Feedback: Mixed Methods Randomized Controlled Trial.,"BACKGROUND


Increasing physical activity (PA) behavior remains a public health priority, and wearable technology is increasingly being used to support behavior change efforts. Using wearables to capture and provide comprehensive, visually persuasive, multidimensional feedback with real-time support may be a promising way of increasing PA in inactive individuals.
OBJECTIVE


This study aims to explore whether a 6-week self-monitoring intervention using composite web-based multidimensional PA feedback with real-time daily feedback supports increased PA in adults.
METHODS


A 6-week, mixed methods, 2-armed exploratory randomized controlled trial with 6-week follow-up was used, whereby low to moderately active (PA level [PAL] <2.0) adults (mean age 51.3 years, SD 8.4 years; women 28/51, 55%) were randomly assigned to receive the self-monitoring intervention (36/51, 71%) or waiting list control (15/51, 29%). Assessment of PA across multiple health-harnessing PA dimensions (eg, PAL, weekly moderate to vigorous intensity PA, sedentary time, and steps), psychosocial cognitions (eg, behavioral regulation, barrier self-efficacy, and habit strength), and health were made at the prerandomization baseline at 6 and 12 weeks. An exploratory analysis of the mean difference and CIs was conducted using the analysis of covariance model. After the 12-week assessment, intervention participants were interviewed to explore their views on the program.
RESULTS


There were no notable differences in any PA outcome immediately after the intervention; however, at 12 weeks, moderate-to-large effects were observed with a mean difference in PAL of 0.09 (95% CI 0.02-0.15; effect size [Hedges g] 0.8), daily moderate-intensity PA of 24 (95% CI 0-45; Hedges g=0.6) minutes, weekly moderate-to-vigorous intensity PA of 195 (95% CI 58-331; Hedges g=0.8) minutes, and steps of 1545 (95% CI 581-2553; Hedges g=0.7). Descriptive analyses suggested that the differences in PA at 12 weeks were more pronounced in women and participants with lower baseline PA levels. Immediately after the intervention, there were favorable differences in autonomous motivation, controlled motivation, perceived competence for PA, and barrier self-efficacy, with the latter sustained at follow-up. Qualitative data implied that the intervention was highly informative for participants and that the real-time feedback element was particularly useful in providing tangible, day-to-day behavioral support.
CONCLUSIONS


Using wearable trackers to capture and present sophisticated multidimensional PA feedback combined with discrete real-time support may be a useful way of facilitating changes in behavior. Further investigation into the ways of optimizing the use of wearables in inactive participants and testing the efficacy of this approach via a robust study design is warranted.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02432924; https://clinicaltrials.gov/ct2/show/NCT02432924.",2022,"Immediately after the intervention, there were favorable differences in autonomous motivation, controlled motivation, perceived competence for PA, and barrier self-efficacy, with the latter sustained at follow-up.","['adults', 'whereby low to moderately active (PA level [PAL] <2.0) adults (mean age 51.3 years, SD 8.4 years; women 28/51, 55', 'Sedentary Adults via Real-time Multidimensional Physical Activity Feedback']","['self-monitoring intervention', 'waiting list control']","['vigorous intensity PA, sedentary time, and steps), psychosocial cognitions (eg, behavioral regulation, barrier self-efficacy, and habit strength), and health', 'autonomous motivation, controlled motivation, perceived competence for PA, and barrier self-efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0919384,"Immediately after the intervention, there were favorable differences in autonomous motivation, controlled motivation, perceived competence for PA, and barrier self-efficacy, with the latter sustained at follow-up.","[{'ForeName': 'Max James', 'Initials': 'MJ', 'LastName': 'Western', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Standage', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Oliver James', 'Initials': 'OJ', 'LastName': 'Peacock', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Nightingale', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}]",JMIR formative research,['10.2196/26525']
3067,35235061,"A pilot trial of quetiapine, lithium, or placebo added to divalproex sodium for hypomanic or manic episodes in ambulatory adults with bipolar I disorder.","BACKGROUND


Many patients with bipolar I disorder do not respond to monotherapy treatment with mood-stabilizing medications, and combination regimens are commonly used in both inpatient and outpatient settings for the acute and maintenance treatment of bipolar disorder. We studied whether combination therapy is more effective than monotherapy for the acute treatment of subjects with bipolar I disorder currently experiencing manic symptoms. The primary hypothesis was that combination treatments would be associated with greater reductions in symptoms of mania and hypomania than monotherapy alone. The secondary hypothesis was that combination therapies would be associated with lower depression levels than monotherapy alone. Last, a post-hoc exploratory aim was used to examine whether the effect of side effect severity on risk-of-dropout would be greater in combination therapies than in monotherapy alone.
RESULTS


In this 12-week, double-blind, placebo-controlled ambulatory pilot trial, participants (n = 75) with bipolar I disorder were randomly assigned to: (1) monotherapy divalproex plus placebo (DVP + PBO), (2) combination therapy of divalproex plus blinded lithium (DVP + Li) or (3) divalproex plus blinded quetiapine (DVP + QTP). Combination therapies (vs. monotherapy) were not associated with improved symptoms of mania, hypomania or depression. The effect of side effect severity on study retention did not differ between combination therapies and monotherapy. However, the risk-of-dropout was significantly greater in the DVP + Li arm versus the DVP + PBO arm.
CONCLUSIONS


No longitudinal differences in mania, hypomania or depression were found between combination therapies and monotherapy. The effect of side effect severity on study retention did not differ between groups. Due to the small sample size and differential rates of attrition between treatment arms, results of this pilot trial must be interpreted with caution. Trial registration ClinicalTrials.gov identifier: NCT00183443.",2022,"Combination therapies (vs. monotherapy) were not associated with improved symptoms of mania, hypomania or depression.","['patients with bipolar I disorder', 'subjects with bipolar I disorder currently experiencing manic symptoms', 'ambulatory adults with bipolar I disorder', 'participants (n\u2009=\u200975) with bipolar I disorder']","['monotherapy', 'monotherapy divalproex plus placebo (DVP\u2009+\u2009PBO), (2) combination therapy of divalproex plus blinded lithium (DVP\u2009+\u2009Li) or (3) divalproex plus blinded quetiapine (DVP\u2009+\u2009QTP', 'placebo', 'quetiapine, lithium, or placebo', 'divalproex sodium', 'Combination therapies (vs. monotherapy']","['depression levels', 'risk-of-dropout', 'mania, hypomania or depression', 'symptoms of mania and hypomania', 'symptoms of mania, hypomania or depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0078144', 'cui_str': 'VDP protocol'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0886883', 'cui_str': 'Divalproex sodium'}]","[{'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0241934', 'cui_str': 'Hypomania'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",75.0,0.110232,"Combination therapies (vs. monotherapy) were not associated with improved symptoms of mania, hypomania or depression.","[{'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Cosgrove', 'Affiliation': 'Bipolar and Depression Research Program, VA Palo Alto Health Care System, 3801 Miranda Avenue (151T), Palo Alto, CA, 94304, USA. veileen@stanford.edu.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Allende', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Road, Stanford, CA, 94305, USA.'}, {'ForeName': 'Iola', 'Initials': 'I', 'LastName': 'Gwizdowski', 'Affiliation': 'Bipolar and Depression Research Program, VA Palo Alto Health Care System, 3801 Miranda Avenue (151T), Palo Alto, CA, 94304, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Grace Fischer', 'Affiliation': 'Bipolar and Depression Research Program, VA Palo Alto Health Care System, 3801 Miranda Avenue (151T), Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ostacher', 'Affiliation': 'Bipolar and Depression Research Program, VA Palo Alto Health Care System, 3801 Miranda Avenue (151T), Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Bipolar and Depression Research Program, VA Palo Alto Health Care System, 3801 Miranda Avenue (151T), Palo Alto, CA, 94304, USA.'}]",International journal of bipolar disorders,['10.1186/s40345-022-00252-w']
3068,35235030,Liposomal bupivacaine nerve block provides better pain control post-total shoulder arthroplasty than continuous indwelling catheter.,"BACKGROUND


Pain control is essential to successful total shoulder arthroplasty (TSA).
MATERIALS AND METHODS


This non-blinded, randomized clinical trial compared shoulder pain, narcotic use, interscalene (IS) block application time, and costs in 76 subjects who were randomly assigned to receive either a single injection IS nerve block of 10 cc (133 mg) liposomal bupivacaine mixed with 10 cc of 0.5% bupivacaine (Group 1), or 20 cc of 0.5% ropivacaine direct injection combined with an indwelling IS nerve block catheter delivering 0.2% ropivacaine at a continual 4 cc/h infusion for the initial 3 post-operative days (Group 2). Surgical time, local anesthesia duration, hospital stay length, morphine milligram equivalents (MME) consumed, worst shoulder pain at 24, 48 and 72 h, and complications were recorded. Patient reported function, pain and activity level surveys were completed before, and 6-week post-TSA (P < 0.05).
RESULTS


Group 1 had less pain 24-h (0.72 ± 0.8 vs. 3.4 ± 2.9, p < 0.0001) and 48-h (2.5 ± 2.2 vs. 4.8 ± 2.6, p = 0.005) post-TSA. At 24-h post-TSA, MME consumption was similar (Group 1 = 4.5 ± 6.4 vs. Group 2 = 3.7 ± 3.8, p = 0.54), but was lower for Group 1 at 48 h (0.0 ± 0.0 vs. 0.64 ± 0.99, p = 0.001). Group 2 had longer IS block application time (10.00 ± 4.6 min vs. 4.84 ± 2.7 min, p < 0.0001). Only group 2 had a strong relationship between MME consumption over the first 24-h post-TSA and pain 24-h post-TSA (r = 0.76, p < 0.0001), a moderate relationship with pain 48-h post-TSA (r = 0.59, P = 0.001), and a weak relationship with pain 72-h post-TSA (r = 0.44, P = 0.02). Significant relationships for these variables were not observed for Group 1 (r ≤ 0.30, p ≥ 0.23). Group 1 IS block costs were less/patient than Group 2 ($190.17 vs. $357.12 USD).
CONCLUSION


A single shot, liposomal bupivacaine interscalene nerve block provided better post-TSA pain control with less narcotic consumption, less time for administration and less healthcare system cost compared to interscalene nerve block using a continuous indwelling catheter.
LEVEL OF EVIDENCE


Level I, Prospective, Randomized.",2022,"A single shot, liposomal bupivacaine interscalene nerve block provided better post-TSA pain control with less narcotic consumption, less time for administration and less healthcare system cost compared to interscalene nerve block using a continuous indwelling catheter.
",['76 subjects'],"['single injection IS nerve block of 10\xa0cc (133\xa0mg) liposomal bupivacaine mixed with 10\xa0cc of 0.5% bupivacaine', 'ropivacaine direct injection combined with an indwelling IS nerve block catheter delivering 0.2% ropivacaine', 'liposomal bupivacaine interscalene nerve block', 'Liposomal bupivacaine nerve block']","['pain 24-h', 'block costs', 'Surgical time, local anesthesia duration, hospital stay length, morphine milligram equivalents (MME) consumed, worst shoulder pain at 24, 48 and 72\xa0h, and complications', 'MME consumption', 'longer IS block application time', 'moderate relationship with pain 48-h post-TSA', 'function, pain and activity level surveys']",[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0589495', 'cui_str': 'Interscalene approach'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0186657', 'cui_str': 'Total shoulder replacement'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",,0.149538,"A single shot, liposomal bupivacaine interscalene nerve block provided better post-TSA pain control with less narcotic consumption, less time for administration and less healthcare system cost compared to interscalene nerve block using a continuous indwelling catheter.
","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Krupp', 'Affiliation': 'Norton Orthopaedic Institute, Louisville, KY, USA.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Orthopaedic Surgery, University of Louisville, Louisville, KY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nyland', 'Affiliation': 'Athletic Training Program Director and Professor, MSAT Program, Kosair Charities College of Health and Natural Sciences, Spalding University, 901 South 4th Street, Louisville, KY, 40203, USA. jnyland@spalding.edu.'}, {'ForeName': 'Colton', 'Initials': 'C', 'LastName': 'Mojesky', 'Affiliation': 'Northstar Anesthesia, Louisville, KY, USA.'}, {'ForeName': 'Deandrea', 'Initials': 'D', 'LastName': 'Perkins', 'Affiliation': 'Northstar Anesthesia, Louisville, KY, USA.'}, {'ForeName': 'Leah Y', 'Initials': 'LY', 'LastName': 'Carreon', 'Affiliation': 'Norton Healthcare, Louisville, KY, USA.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-022-04386-5']
3069,35238406,Deception in simulation-based education: a randomised controlled trial of the effect of deliberate deception on the performance of anaesthesia trainees.,"The use of deliberate deception in simulation allows for a level of realism that is not normally feasible. However, the use of deception is controversial, and carries the risk of psychological harm to learners. There are currently no quantitative data on the effect of deception on learner performance, making it difficult to judge its usefulness. The objective of this study was to examine the impact of deception on learners' performance during a life-threatening scenario. In this simulation study, second-year anaesthesia residents were randomly allocated into two groups: the non-deception group was told that the participating consultant was acting a part, while the deception group was told that the consultant was a subject in the study. Learners then participated in a simulated crisis that presented them with situational opportunities to challenge the consultant regarding clearly wrong decisions. Two independent raters scored the performances using the modified advocacy-inquiry scale. Forty-four participants were analysed. The median (IQR [range]) highest scoring modified advocacy-inquiry scale was 5.0 (4.5-5.1 [4.0-5.5]) for the non-deception group and 4.0 (3.0-4.0 [2.5-5.0]) for the deception group, (p < 0.001), and the median total number of challenges per participant was 26.8 (21.0-31.1 [16.5-35.5]) and 18.0 (14.3-23.3 [7.0-33.0]), respectively (p = 0.001). Trainees exposed to deliberate deception, who thought that the consultant anaesthetist was a subject, had a less-effective best challenge, likely mimicking real-life behaviour. Deliberate deception appears to modify behaviour, particularly relating to communication involving hierarchical relationships. This technique may improve authenticity, especially with a steep power gradient, and so has demonstrable value which must be balanced against the ethical considerations.",2022,"Trainees exposed to deliberate deception, who thought that the consultant anaesthetist was a subject, had a less-effective best challenge, likely mimicking real-life behaviour.",['second-year anaesthesia residents'],['deliberate deception'],"[""learners' performance"", 'median (IQR [range]) highest scoring modified advocacy-inquiry scale', 'median total number of challenges per participant']","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0024195', 'cui_str': 'Deception'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0150446', 'cui_str': 'Advocacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",44.0,0.0559521,"Trainees exposed to deliberate deception, who thought that the consultant anaesthetist was a subject, had a less-effective best challenge, likely mimicking real-life behaviour.","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Friedman', 'Affiliation': 'Department of Anesthesia and Pain Management, Sinai Health Systems, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Bould', 'Affiliation': ""Department of Anesthesiology, The Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Pattni', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Malavade', 'Affiliation': 'Department of Anesthesia and Pain Management, Sinai Health Systems, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Nakatani', 'Affiliation': 'Department of Anesthesia and Pain Management Sunnybrook Health Science Centre, University of Toronto, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': 'Department of Anesthesia and Pain Management Sunnybrook Health Science Centre, University of Toronto, Canada.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Alam', 'Affiliation': 'Department of Anesthesia and Pain Management Sunnybrook Health Science Centre, University of Toronto, Canada.'}]",Anaesthesia,['10.1111/anae.15693']
3070,35238401,Time to medical fitness for discharge following surgical evacuation of chronic subdural haematoma with general or regional anaesthesia: a prospective randomised trial.,"General or regional anaesthesia can be used for chronic subdural haematoma evacuation, but no study has compared these types of anaesthesia in terms of peri-operative outcomes. This single-centre, prospective, randomised study included adult patients (age ≥ 18 years) undergoing surgical chronic subdural haematoma evacuation. Patients were randomly allocated to general (target-controlled total intravenous anaesthesia with propofol and remifentanil) or regional anaesthesia (bilateral scalp block with remifentanil sedation if required). The primary outcome measure was duration of hospital stay, based on the day patients were judged by an investigator blinded from the allocation group to be medically fit for discharge. Secondary outcomes included: rate of regional anaesthesia failure; rate of intra-operative and postoperative adverse events at 24 hours; and pain scores at 24 hours. Data from 60 patients were analysed (30 general anaesthesia and 30 regional anaesthesia). Median (IQR [range]) time until patients were judged medically fit for discharge was 3 (3-3 [2-10]) days and 3 (2-5 [2-15]) days for general and regional anaesthesia, respectively (p = 0.700). Regional anaesthesia failed in two patients. There were more intra-operative adverse events in patients who received general anaesthesia (25 vs. 11, respectively; p = 0.001). The occurrence of postoperative adverse events was similar for general and regional anaesthesia (16 vs. 13 patients, respectively; p = 0.605). In patients requiring chronic subdural haematoma evacuation, general and regional anaesthesia are comparable in terms of duration of time until medically fit for discharge and occurrence of postoperative complications. The rate of intra-operative adverse events (mainly arterial hypotension) is greater with general anaesthesia.",2022,"There were more intra-operative adverse events in patients who received general anaesthesia (25 vs. 11, respectively; p = 0.001).","['adult patients (age\u2009≥\u200918\u2009years) undergoing surgical chronic subdural haematoma evacuation', '60 patients were analysed (30 general anaesthesia and 30 regional anaesthesia', 'chronic subdural haematoma with general or regional anaesthesia']",['general (target-controlled total intravenous anaesthesia with propofol and remifentanil) or regional anaesthesia (bilateral scalp block with remifentanil sedation if required'],"['intra-operative adverse events', 'occurrence of postoperative adverse events', 'rate of intra-operative adverse events (mainly arterial hypotension', 'Median (IQR [range]) time', 'duration of hospital stay', 'rate of regional anaesthesia failure; rate of intra-operative and postoperative adverse events at 24\u2009hours; and pain scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C3163670', 'cui_str': 'Target controlled total intravenous anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",60.0,0.165785,"There were more intra-operative adverse events in patients who received general anaesthesia (25 vs. 11, respectively; p = 0.001).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hestin', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Caen University Hospital and Caen Normandy University, Caen, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kamga Totouom', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Caen University Hospital and Caen Normandy University, Caen, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gaberel', 'Affiliation': 'Department of Neurosurgery, Caen University Hospital and Caen Normandy University, Caen, France.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Parienti', 'Affiliation': 'Department of Clinical Research and Biostatistics, Caen University Hospital and Caen Normandy University, Caen, France.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Hanouz', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Caen University Hospital and Caen Normandy University, Caen, France.'}]",Anaesthesia,['10.1111/anae.15667']
3071,35235573,Expanding syphilis test uptake using rapid dual self-testing for syphilis and HIV among men who have sex with men in China: A multiarm randomized controlled trial.,"BACKGROUND


Low syphilis testing uptake is a major public health issue among men who have sex with men (MSM) in many low- and middle-income countries. Syphilis self-testing (SST) may complement and extend facility-based testing. We aimed to evaluate the effectiveness and costs of providing SST on increasing syphilis testing uptake among MSM in China.
METHODS AND FINDINGS


An open-label, parallel 3-arm randomized controlled trial (RCT) was conducted between January 7, 2020 and July 17, 2020. Men who were at least 18 years of age, had condomless anal sex with men in the past year, reported not testing for syphilis in the last 6 months, and had a stable residence with mailing addresses were recruited from 124 cities in 26 Chinese provinces. Using block randomization with blocks of size 12, enrolled participants were randomly assigned (1:1:1) into 3 arms: standard of care arm, standard SST arm, and lottery incentivized SST arm (1 in 10 chance to win US$15 if they had a syphilis test). The primary outcome was the proportion of participants who tested for syphilis during the trial period and confirmed with photo verification and between arm comparisons were estimated with risk differences (RDs). Analyses were performed on a modified intention-to-treat basis: Participants were included in the complete case analysis if they had initiated at least 1 follow-up survey. The Syphilis/HIV Duo rapid test kit was used. A total of 451 men were enrolled. In total, 136 (90·7%, 136/150) in the standard of care arm, 142 (94·0%, 142/151) in the standard of SST arm, and 137 (91·3%, 137/150) in the lottery incentivized SST arm were included in the final analysis. The proportion of men who had at least 1 syphilis test during the trial period was 63.4% (95% confidence interval [CI]: 55.5% to 71.3%, p = 0.001) in the standard SST arm, 65.7% (95% CI: 57.7% to 73.6%, p = 0.0002) in the lottery incentivized SST arm, and 14.7% (95% CI: 8.8% to 20.7%, p < 0.001) in the standard of care arm. The estimated RD between the standard SST and standard of care arm was 48.7% (95% CI: 37.8% to 58.4%, p < 0.001). The majority (78.5%, 95% CI: 72.7% to 84.4%, p < 0.001) of syphilis self-testers reported never testing for syphilis. The cost per person tested was US$26.55 for standard SST, US$28.09 for the lottery incentivized SST, and US$66.19 for the standard of care. No study-related adverse events were reported during the study duration. Limitation was that the impact of the Coronavirus Disease 2019 (COVID-19) restrictions may have accentuated demand for decentralized testing.
CONCLUSIONS


Compared to standard of care, providing SST significantly increased the proportion of MSM testing for syphilis in China and was cheaper (per person tested).
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR1900022409.",2022,"The majority (78.5%, 95% CI: 72.7% to 84.4%, p < 0.001) of syphilis self-testers reported never testing for syphilis.","['A total of 451 men were enrolled', 'men who have sex with men in China', 'January 7, 2020 and July 17, 2020', 'men who have sex with men (MSM) in many low- and middle-income countries', 'MSM in China', 'Men who were at least 18 years of age, had condomless anal sex with men in the past year, reported not testing for syphilis in the last 6 months, and had a stable residence with mailing addresses were recruited from 124 cities in 26 Chinese provinces']","['standard of care arm, standard SST arm, and lottery incentivized SST', 'SST', 'Syphilis self-testing (SST']","['estimated RD', 'adverse events', 'proportion of participants who tested for syphilis']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037659', 'cui_str': 'Somatostatin'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}]",451.0,0.312016,"The majority (78.5%, 95% CI: 72.7% to 84.4%, p < 0.001) of syphilis self-testers reported never testing for syphilis.","[{'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Ong', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Peizhen', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Weideman', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'M Kumi', 'Initials': 'MK', 'LastName': 'Smith', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota Twin Cities, Minneapolis, Minnesota, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marks', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': 'Division of Community Health and Research, Eastern Virginia Medical School, Norfolk, Virginia, United States of America.'}, {'ForeName': 'Weibin', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Fern', 'Initials': 'F', 'LastName': 'Terris-Prestholt', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}]",PLoS medicine,['10.1371/journal.pmed.1003930']
3072,35235571,Risk of cancer with angiotensin-receptor blockers increases with increasing cumulative exposure: Meta-regression analysis of randomized trials.,"Angiotensin-receptor blockers (ARBs) are a class of drugs approved for the treatment of several common conditions, such as hypertension and heart failure. Recently, regulatory agencies have started to identify possibly carcinogenic nitrosamines and azido compounds in a multitude of formulations of several ARBs, resulting in progressive recalls. Furthermore, data from several randomized controlled trials suggested that there is also a clinically increased risk of cancer and specifically lung cancer with ARBs; whereas other trials suggested no increased risk. The purpose of this analysis was to provide additional insight into the ARB-cancer link by examining whether there is a relationship between degree of cumulative exposure to ARBs and risk of cancer in randomized trials. Trial-level data from ARB Trialists Collaboration including 15 randomized controlled trials was extracted and entered into meta-regression analyses. The two co-primary outcomes were the relationship between cumulative exposure to ARBs and risk of all cancers combined and the relationship between cumulative exposure and risk of lung cancer. A total of 74,021 patients were randomized to an ARB resulting in a total cumulative exposure of 172,389 person-years of exposure to daily high dose (or equivalent). 61,197 patients were randomized to control. There was a highly significant correlation between the degree of cumulative exposure to ARBs and risk of all cancers combined (slope = 0.07 [95% CI 0.03 to 0.11], p<0.001), and also lung cancer (slope = 0.16 [95% CI 0.05 to 0.27], p = 0.003). Accordingly, in trials where the cumulative exposure was greater than 3 years of exposure to daily high dose, there was a statistically significant increase in risk of all cancers combined (I2 = 31.4%, RR 1.11 [95% CI 1.03 to 1.19], p = 0.006). There was a statistically significant increase in risk of lung cancers in trials where the cumulative exposure was greater than 2.5 years (I2 = 0%, RR 1.21 [95% CI 1.02 to 1.44], p = 0.03). In trials with lower cumulative exposure to ARBs, there was no increased risk of all cancers combined or lung cancer. Cumulative exposure-risk relationship with ARBs was independent of background angiotensin-converting enzyme inhibitor treatment or the type of control (i.e. placebo or non-placebo control). Since this is a trial-level analysis. the effects of patient characteristics such as age and smoking status could not be examined due to lack of patient-level data. In conclusion, this analysis, for the first time, reveals that risk of cancer with ARBs (and specifically lung cancer) increases with increasing cumulative exposure to these drugs. The excess risk of cancer with long-term ARB use has public health implications.",2022,"There was a statistically significant increase in risk of lung cancers in trials where the cumulative exposure was greater than 2.5 years (I2 = 0%, RR 1.21 [95% CI 1.02 to 1.44], p = 0.03).","['61,197 patients', '74,021 patients']","['angiotensin-receptor blockers', 'ARB', 'Angiotensin-receptor blockers (ARBs']","['cumulative exposure', 'lung cancer', 'risk of all cancers combined or lung cancer', 'cumulative exposure to ARBs and risk of all cancers combined and the relationship between cumulative exposure and risk of lung cancer', 'risk of all cancers combined', 'risk of lung cancers', 'degree of cumulative exposure to ARBs and risk of all cancers combined']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",74021.0,0.380767,"There was a statistically significant increase in risk of lung cancers in trials where the cumulative exposure was greater than 2.5 years (I2 = 0%, RR 1.21 [95% CI 1.02 to 1.44], p = 0.03).","[{'ForeName': 'Ilke', 'Initials': 'I', 'LastName': 'Sipahi', 'Affiliation': 'Department of Cardiology, Acibadem University Medical School, Istanbul, Turkey.'}]",PloS one,['10.1371/journal.pone.0263461']
3073,35235550,Protection to self and to one's sexual partner after human papillomavirus vaccination: Preliminary analysis from the TRAP-HPV study.,"BACKGROUND


It is unknown whether recently HPV-vaccinated individuals confer protection against vaccine-preventable HPV types to their partners.
METHODS


Participants, 18-45 years old, living in Montreal, Canada and in a heterosexual relationship of 6 months or less were randomly assigned to receive the intervention HPV vaccine, Gardasil or Gardasil 9, or active control (AC), Avaxim, a Hepatitis A vaccine. Couples attended a maximum of 6 clinic visits (baseline, and at 2, 4, 6, 9, and 12 months) and provided genital samples for detection of 36 HPV genotypes. Participants were vaccinated at baseline and at 2 and 6 months. We used Cox proportional hazards regression models to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for associations between the administered vaccine and infections at the HPV episode level.
RESULTS


We restricted analyses to 273 participants (intervention: n = 141, AC: n = 132) who had at least 2 visits with valid HPV data. The HR of becoming positive for a given vaccine-preventable HPV type in the intervention group among those who received at least one dose compared with AC was 0.47 (CI:0.23-0.97). Comparing individuals with HPV-vaccinated versus AC-vaccinated partners, there was no difference in risk of becoming positive for a given vaccine-preventable HPV type among those whose partners received at least one (HR = 1.46, CI:0:73-2.94) or two (HR = 0.78, CI:0:31-1.96) doses.
CONCLUSIONS


Our study provides inconclusive evidence that individuals whose partner recently received an HPV vaccine are protected from vaccine-preventable types but demonstrates that vaccinated individuals are at lower risk of incident infections.Trial registration number: NCT01824537.",2022,"Comparing individuals with HPV-vaccinated versus AC-vaccinated partners, there was no difference in risk of becoming positive for a given vaccine-preventable HPV type among those whose partners received at least one (HR = 1.46, CI:0:73-2.94) or two (HR = 0.78, CI:0:31-1.96) doses.
","['Participants, 18-45 years old, living in Montreal, Canada and in a heterosexual relationship of 6 months or less', '273 participants (intervention: n = 141, AC: n = 132) who had at least 2 visits with valid HPV data']","['HPV vaccine', 'intervention HPV vaccine, Gardasil or Gardasil 9, or active control (AC), Avaxim, a Hepatitis A vaccine']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0556476', 'cui_str': 'Heterosexual relationship'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}]","[{'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1721787', 'cui_str': 'Gardasil'}, {'cui': 'C3864947', 'cui_str': 'Gardasil 9'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019159', 'cui_str': 'Viral hepatitis, type A'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],,0.220826,"Comparing individuals with HPV-vaccinated versus AC-vaccinated partners, there was no difference in risk of becoming positive for a given vaccine-preventable HPV type among those whose partners received at least one (HR = 1.46, CI:0:73-2.94) or two (HR = 0.78, CI:0:31-1.96) doses.
","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'MacCosham', 'Affiliation': ""Division of Cancer Epidemiology, McGill University, Montreal, QC, Canada Department of Family and Community Medicine and MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada Department of Family Medicine, McGill University, Montreal, QC, Canada Service de Microbiologie Médicale et Service d'Infectiologie, Départements de Médecine et de médecine de laboratoire, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, QC, Canada.""}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'El-Zein', 'Affiliation': ''}, {'ForeName': 'Ann N', 'Initials': 'AN', 'LastName': 'Burchell', 'Affiliation': ''}, {'ForeName': 'Pierre-Paul', 'Initials': 'PP', 'LastName': 'Tellier', 'Affiliation': ''}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Coutlée', 'Affiliation': ''}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Franco', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001620']
3074,35235870,"Recurrent venous thromboembolism and major bleeding in patients with localised, locally advanced or metastatic cancer: an analysis of the Caravaggio study.","BACKGROUND


Patients with cancer-associated venous thromboembolism (VTE) have a high risk of VTE recurrence and anticoagulant treatment-related bleeding, but the correlation of these risks with the cancer stage is unclear.
METHODS


We evaluated the risks of VTE recurrence and treatment-related major bleeding according to the cancer stage in patients with VTE and solid cancer randomised to apixaban or dalteparin in the Caravaggio study. Cancer stage was categorised by expert cancer physicians according to pre-specified criteria, and study outcomes were adjudicated by an independent committee unaware of cancer stage and treatment allocation.
RESULTS


Of the 1034 patients included in this analysis, 217 (21.0%) had localised cancer, 279 (27.0%) locally advanced cancer and 503 (48.7%) metastatic cancer. Cancer stage was undetermined in 35 patients (3.4%). VTE recurrence and major bleeding rates were 2.8% and 3.2% in patients with localised cancer, respectively. In comparison to patients with localised cancer, the VTE recurrence rate was higher in patients with locally advanced cancer (7.5%, hazard ratio [HR] = 2.8, 95% confidence interval [CI] = 1.1-6.9) and metastatic cancer (8.7%, HR = 3.3, CI = 1.4-7.7, CI). Patients with metastatic cancer had numerically increased major bleedings compared to those with localised cancer (5.2%, HR = 1.65, CI = 0.7-3.8). The efficacy and safety of apixaban and dalteparin across patients with different cancer stages were consistent with the findings observed in the overall patients with cancer randomised in the study.
CONCLUSIONS


Patients with locally advanced and metastatic cancer have a higher rate of VTE recurrence than patients with localised cancer with no statistically significant difference in treatment-related major bleeding.",2022,"Patients with metastatic cancer had numerically increased major bleedings compared to those with localised cancer (5.2%, HR = 1.65, CI = 0.7-3.8).","['Patients with cancer-associated venous thromboembolism (VTE', '1034 patients included in this analysis, 217 (21.0%) had localised cancer, 279 (27.0%) locally advanced cancer\xa0and 503 (48.7%) metastatic cancer', 'patients with different cancer stages', 'patients with localised, locally advanced or metastatic cancer', 'Patients with locally advanced and metastatic cancer', 'Patients with metastatic cancer', 'patients with VTE and solid cancer randomised to']","['apixaban and dalteparin', 'apixaban or dalteparin']","['VTE recurrence and major bleeding rates', 'VTE recurrence rate', 'major bleedings', 'efficacy and safety', 'VTE recurrence', 'metastatic cancer', 'Recurrent venous thromboembolism and major bleeding', 'Cancer stage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027646', 'cui_str': 'Cancer staging'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205208', 'cui_str': 'Solid'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0206461', 'cui_str': 'Dalteparin'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027646', 'cui_str': 'Cancer staging'}]",1034.0,0.307562,"Patients with metastatic cancer had numerically increased major bleedings compared to those with localised cancer (5.2%, HR = 1.65, CI = 0.7-3.8).","[{'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Verso', 'Affiliation': 'Internal, Vascular and Emergency Medicine - Stroke Unit, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Agnelli', 'Affiliation': 'Internal, Vascular and Emergency Medicine - Stroke Unit, University of Perugia, Perugia, Italy. Electronic address: giancarlo.agnelli@unipg.it.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Munoz', 'Affiliation': 'Medical Oncology Service, Hospital General Universitario Gregorio Marañón, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': ""Brigham and Women's Hospital, Hematology Division, Harvard Medical School, Boston, United States.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sanchez', 'Affiliation': 'Université de Paris, Service de Pneumologie et Soins Intensifs, AP-HP, Hôpital Européen Georges Pompidou, INSERM UMR-S 1140 Innovative Therapies in Haemostasis, F-75006, Paris, France; F-CRIN INNOVTE, F-42000, St-Etienne, France.'}, {'ForeName': 'Menno', 'Initials': 'M', 'LastName': 'Huisman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brenner', 'Affiliation': 'Institute of Hematology and BMT Rambam Health Care Campus Technion, Israel Institute of Technology Haifa, Israel.'}, {'ForeName': 'Gualberto', 'Initials': 'G', 'LastName': 'Gussoni', 'Affiliation': 'Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan, Italy.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Cohen', 'Affiliation': ""Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London, United Kingdom.""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Becattini', 'Affiliation': 'Internal, Vascular and Emergency Medicine - Stroke Unit, University of Perugia, Perugia, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.01.023']
3075,35235859,Improvement of inflammatory status following saffron (Crocus sativus L.) and resistance training in elderly hypertensive men: A randomized controlled trial.,"OBJECTIVE


We sought to determine the independent and combined effects of saffron and resistance training on markers of inflammation and cardiovascular risk factors in elderly hypertensive patients.
METHODS


Hypertensive older men were randomly assigned to a control group (C) or one of three experimental groups [saffron consumption (S), resistance training (R), and resistance training + saffron (RS)] for 12 weeks. Inflammatory markers and lipid profiles were measured at baseline and following the 12-week intervention period. Patients in S and RS received one tablet containing 200 mg of saffron daily. Primary outcomes were analyzed using univariate analysis of covariance (ANCOVA).
RESULTS


The RS group had significantly greater reductions in leptin, resistin, MCP-1, and IL-6 as compared with the C, S, and R groups (ps < 0.05). In addition, the RS, S, and R groups had significantly greater reductions in TC and greater increases in HDL-c as compared with the C group (ps < 0.05), but there were no differences between the RS, S, and R groups. Finally, there were no differences between groups for TNF-α, homocysteine, and hs-CRP (ps > 0.05).
CONCLUSION


Combining Saffron and resistance training can reduce inflammation and cardiovascular disease risk factors associated with increased risk for hypertension in older men with hypertension.",2022,"The RS group had significantly greater reductions in leptin, resistin, MCP-1, and IL-6 as compared with the C, S, and R groups (ps < 0.05).","['elderly hypertensive patients', 'elderly hypertensive men', 'older men with hypertension', 'Hypertensive older men']","['saffron (Crocus sativus L.) and resistance training', 'Saffron and resistance training', 'saffron and resistance training', 'control group (C) or one of three experimental groups [saffron consumption (S), resistance training (R), and resistance training + saffron (RS']","['Inflammatory markers and lipid profiles', 'leptin, resistin, MCP-1, and IL-6', 'HDL-c', 'TNF-α, homocysteine, and hs-CRP']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0946614', 'cui_str': 'Saffron Crocus'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",,0.0413858,"The RS group had significantly greater reductions in leptin, resistin, MCP-1, and IL-6 as compared with the C, S, and R groups (ps < 0.05).","[{'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Mojtahedi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand-Moghadam', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran. Electronic address: babak.hooshmand@mail.um.ac.ir.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rosenkranz', 'Affiliation': 'School of Science and Health, University of Western Sydney, Sydney, Australia; Department of Food, Nutrition, Dietetics and Health, Kansas State University, Manhattan, KS, USA.'}, {'ForeName': 'Ziba', 'Initials': 'Z', 'LastName': 'Shourideh', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Amirshaghaghi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Shabkhiz', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, Iran.'}]",Experimental gerontology,['10.1016/j.exger.2022.111756']
3076,35235856,Designing Psychosocial Intervention Pilot Studies: A Tutorial for Palliative Care Investigators.,"This is a tutorial on designing a persuasive pilot study of a psychosocial intervention (e.g., behavioral symptom management) in the palliative care setting. This tutorial is most relevant for early stages of intervention research that aims to progress toward a randomized controlled trial with a high degree of internal validity. Broadly, a pilot study aims to address multiple elements of feasibility and acceptability so that investigators are well positioned for the next study in their program of research. To assist investigators in writing compelling grant applications we designed this tutorial as an annotated checklist of goals that a pilot study within the palliative care domain should seek to accomplish. These goals include the following: 1) begin with the end in mind, 2) use a formal conceptual model, 3) use measures with strong psychometric properties, 4) justify the timing of study sessions and assessments, 5) test recruitment methods, 6) estimate retention, 7) assess interventionist fidelity, 8) assess acceptability of the intervention, 9) assess feasibility, and 10) identify barriers to the next study. We elaborate on these goals by describing an ongoing pilot study testing the feasibility and acceptability of a psychosocial pain management intervention for patients with advanced cancer. Pilot studies are crucial for building a successful program of research, but they are also limited in terms of their sample size and overall objectives. A persuasive pilot study is one that is limited yet useful rather than limited and trivial. Key Message: This article is a tutorial for palliative care investigators on designing a persuasive pilot study of a psychosocial intervention. A pilot study aims to address multiple elements of feasibility and acceptability so that investigators are well positioned for the next study in their program of research.",2022,"Pilot studies are crucial for building a successful program of research, but they are also limited in terms of their sample size and overall objectives.",['patients with advanced cancer'],"['psychosocial pain management intervention', 'psychosocial intervention']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0418245,"Pilot studies are crucial for building a successful program of research, but they are also limited in terms of their sample size and overall objectives.","[{'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Winger', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham NC, USA; Duke Cancer Institute, Durham NC, USA. Electronic address: joseph.winger@duke.edu.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Kelleher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham NC, USA; Duke Cancer Institute, Durham NC, USA.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham NC, USA; Duke Cancer Institute, Durham NC, USA.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Somers', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham NC, USA; Duke Cancer Institute, Durham NC, USA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Samsa', 'Affiliation': 'Duke Cancer Institute, Durham NC, USA; Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2022.02.338']
3077,35235834,Virtual AppLication-Supported Environment to INcrease Exercise During Cardiac Rehabilitation Study (VALENTINE) Study: Rationale and Design.,"BACKGROUND


In-person, exercise-based cardiac rehabilitation improves physical activity and reduces morbidity and mortality for patients with cardiovascular disease. However, activity levels may not be optimized and decline over time after patients graduate from cardiac rehabilitation. Scalable interventions through mobile health (mHealth) technologies have the potential to augment activity levels and extend the benefits of cardiac rehabilitation.
METHODS


The VALENTINE Study is a prospective, randomized-controlled, remotely-administered trial designed to evaluate an mHealth intervention to supplement cardiac rehabilitation for low- and moderate-risk patients (ClinicalTrials.gov NCT04587882). Participants are randomized to the control or intervention arms of the study. Both groups receive a compatible smartwatch (Fitbit Versa 2 or Apple Watch 4) and usual care. Participants in the intervention arm of the study additionally receive a just-in-time adaptive intervention (JITAI) delivered as contextually tailored notifications promoting low-level physical activity and exercise throughout the day. In addition, they have access to activity tracking and goal setting through the mobile study application and receive weekly activity summaries via email. The primary outcome is change in 6-minute walk distance at 6-months and, secondarily, change in average daily step count. Exploratory analyses will examine the impact of notifications on immediate short-term smartwatch-measured step counts and exercise minutes.
CONCLUSIONS


The VALENTINE study leverages innovative techniques in behavioral and cardiovascular disease research and will make a significant contribution to our understanding of how to support patients using mHealth technologies to promote and sustain physical activity.",2022,"Exploratory analyses will examine the impact of notifications on immediate short-term smartwatch-measured step counts and exercise minutes.
",['patients with cardiovascular disease'],"['just-in-time adaptive intervention (JITAI) delivered as contextually tailored notifications promoting low-level physical activity and exercise throughout the day', 'Virtual AppLication-Supported Environment to INcrease Exercise', 'exercise-based cardiac rehabilitation', 'compatible smartwatch (Fitbit Versa 2 or Apple Watch 4) and usual care', 'mHealth intervention to supplement cardiac rehabilitation']","['activity levels', 'change in 6-minute walk distance at 6-months and, secondarily, change in average daily step count', 'morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0510178,"Exploratory analyses will examine the impact of notifications on immediate short-term smartwatch-measured step counts and exercise minutes.
","[{'ForeName': 'V Swetha', 'Initials': 'VS', 'LastName': 'Jeganathan', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Internal Medicine, University of Michigan, MI.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Golbus', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Internal Medicine, University of Michigan, MI; Michigan Integrated Center for Health Analytics and Medical Prediction (MiCHAMP), University of Michigan, MI. Electronic address: jgolbus@med.umich.edu.'}, {'ForeName': 'Kashvi', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': 'Michigan Integrated Center for Health Analytics and Medical Prediction (MiCHAMP), University of Michigan, MI; Department of Internal Medicine, University of Missouri Kansas City, Kansas City, MO.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Luff', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Internal Medicine, University of Michigan, MI.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Dempsey', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Boyden', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Internal Medicine, Spectrum Health, MI.'}, {'ForeName': 'Melvyn', 'Initials': 'M', 'LastName': 'Rubenfire', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Internal Medicine, University of Michigan, MI.'}, {'ForeName': 'Brahmar', 'Initials': 'B', 'LastName': 'Mukherjee', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Klasnja', 'Affiliation': 'School of Information, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Kheterpal', 'Affiliation': 'Department of Anesthesiology, University of Michigan, MI.'}, {'ForeName': 'Brahmajee K', 'Initials': 'BK', 'LastName': 'Nallamothu', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Internal Medicine, University of Michigan, MI; Michigan Integrated Center for Health Analytics and Medical Prediction (MiCHAMP), University of Michigan, MI; The Center for Clinical Management and Research, Ann Arbor VA Medical Center, MI.'}]",American heart journal,['10.1016/j.ahj.2022.02.012']
3078,35235823,Conducting a representative national randomized control trial of tailored clinical decision support for nurses remotely: Methods and implications.,"Clinical Decision Support (CDS) systems, patient specific evidence delivered to clinicians via the electronic health record (EHR) at the right time and in the right format, has the potential to improve patient outcomes. Unfortunately, outcomes of CDS research are mixed. A potential cause lies in its testing. Many CDS are implemented in practice without sufficient testing, potentially leading to patient harm. When testing is conducted, most research has focused on ""what"" evidence to provide with little attention to the impact of the CDS display format (e.g., textual, graphical) on the user. In an adequately powered randomized control trial with 220 hospital based registered nurses, we will compare 4 randomly assigned CDS format groups (text, text table, text graphs, tailored to subject's graph literacy score) for effects on decision time and simulated patient outcomes. We recruit using state based professional registries, which allows access to participants from multiple institutions across the nation. We use online survey software (REDCap) for efficient study workflow including screening, informed consent documentation, pre-experiment demographic data collection including a graph literacy questionnaire used in randomization. The CDS prototype is accessed via a web app and the simulation-based experiment is conducted remotely at a subject's local computer using video-conferencing software. Also included are 6 post intervention surveys to assess cognitive workload, usability, numeracy, format preference, CDS utilization rationale, and CDS interpretation. Our methods are replicable and scalable for testing of health information technologies and have the potential to improve the safety and effectiveness of these technologies across disciplines.",2022,Our methods are replicable and scalable for testing of health information technologies and have the potential to improve the safety and effectiveness of these technologies across disciplines.,['220 hospital based registered nurses'],['online survey software (REDCap'],"['cognitive workload, usability, numeracy, format preference, CDS utilization rationale, and CDS interpretation']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}]",220.0,0.102517,Our methods are replicable and scalable for testing of health information technologies and have the potential to improve the safety and effectiveness of these technologies across disciplines.,"[{'ForeName': 'Karen Dunn', 'Initials': 'KD', 'LastName': 'Lopez', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, USA. Electronic address: Karen-dunn-lopez@uiowa.edu.'}, {'ForeName': 'Yingwei', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: y.yao@ufl.edu.'}, {'ForeName': 'Hwayoung', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: hcho@ufl.edu.'}, {'ForeName': 'Fabiana Cristina Dos', 'Initials': 'FCD', 'LastName': 'Santos', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: fabianadossantos@ufl.edu.'}, {'ForeName': 'Olatunde O', 'Initials': 'OO', 'LastName': 'Madandola', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: omadandola@ufl.edu.'}, {'ForeName': 'Ragnhildur I', 'Initials': 'RI', 'LastName': 'Bjarnadottir', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: rib@ufl.edu.'}, {'ForeName': 'Tamara Goncalves Rezende', 'Initials': 'TGR', 'LastName': 'Macieira', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: tmacie2@ufl.edu.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Garcia', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: amanda.garcia@ufl.edu.'}, {'ForeName': 'Karen J B', 'Initials': 'KJB', 'LastName': 'Priola', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: kbyer@ufl.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, USA. Electronic address: jessica-s-wolf@uiowa.edu.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Bian', 'Affiliation': 'College of Medicine, Health Outcomes & Biomedical Informatics, University of Florida, Gainesville, FL, USA. Electronic address: bianjiang@ufl.edu.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Wilkie', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: diwilkie@ufl.edu.'}, {'ForeName': 'Gail M', 'Initials': 'GM', 'LastName': 'Keenan', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, FL, USA. Electronic address: gkeenan@ufl.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2022.106712']
3079,35235821,Cardiovascular benefits of digoxin and empagliflozin in patients with chronic heart failure: the DIG trial revisited.,,2022,,['patients with chronic heart failure'],['digoxin and empagliflozin'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]",[],,0.155276,,"[{'ForeName': 'Haoyi', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'St Francis Hospital, The Heart Center, Roslyn, NY. Electronic address: Haoyi.Zheng@chsli.org.'}]",The American journal of medicine,['10.1016/j.amjmed.2022.01.050']
3080,35236099,Developments in Exercise Capacity Assessment in Heart Failure Clinical Trials and the Rationale for the Design of METEORIC-HF.,"Heart failure with reduced ejection fraction (HFrEF) is a highly morbid condition for which exercise intolerance is a major manifestation. However, methods to assess exercise capacity in HFrEF vary widely in clinical practice and in trials. We describe advances in exercise capacity assessment in HFrEF and a comparative analysis of how various therapies available for HFrEF impact exercise capacity. Current guideline-directed medical therapy has indirect effects on cardiac performance with minimal impact on measured functional capacity. Omecamtiv mecarbil is a novel selective cardiac myosin activator that directly increases cardiac contractility and in a phase 3 cardiovascular outcomes study significantly reduced the primary composite end point of time to first heart failure event or cardiovascular death in patients with HFrEF. The objective of the METEORIC-HF trial (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure) is to assess the effect of omecamtiv mecarbil versus placebo on multiple components of functional capacity in HFrEF. The primary end point is to test the effect of omecamtiv mecarbil compared with placebo on peak oxygen uptake as measured by cardiopulmonary exercise testing after 20 weeks of treatment. METEORIC-HF will provide state-of-the-art assessment of functional capacity by measuring ventilatory efficiency, circulatory power, ventilatory anaerobic threshold, oxygen uptake recovery kinetics, daily activity, and quality-of-life assessment. Thus, the METEORIC-HF trial will evaluate the potential impact of increased myocardial contractility with omecamtiv mecarbil on multiple important measures of functional capacity in ambulatory patients with symptomatic HFrEF. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT03759392.",2022,Omecamtiv mecarbil is a novel selective cardiac myosin activator that directly increases cardiac contractility and in a phase 3 cardiovascular outcomes study significantly reduced the primary composite end point of time to first heart failure event or cardiovascular death in patients with HFrEF.,"['patients with HFrEF', 'HFrEF', 'Heart Failure', 'ambulatory patients with symptomatic HFrEF']","['omecamtiv mecarbil versus placebo', 'reduced ejection fraction (HFrEF', 'placebo']","['peak oxygen uptake', 'ventilatory efficiency, circulatory power, ventilatory anaerobic threshold, oxygen uptake recovery kinetics, daily activity, and quality-of-life assessment', 'cardiac contractility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C2932035', 'cui_str': 'omecamtiv mecarbil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",,0.148213,Omecamtiv mecarbil is a novel selective cardiac myosin activator that directly increases cardiac contractility and in a phase 3 cardiovascular outcomes study significantly reduced the primary composite end point of time to first heart failure event or cardiovascular death in patients with HFrEF.,"[{'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Division of Cardiology, Massachusetts General Hospital, Boston (G.D.L.).'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'BHF Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Scotland (K.F.D.).'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, the Netherlands (A.A.V.).'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Cohen-Solal', 'Affiliation': 'Paris University, UMR-S 942, Department of Cardiology, Lariboisiere Hospital, Assistance Publique Hopitaux de Paris, France (A.C.-S.).'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, ASST Spedali Civili, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Italy (M.M.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Whellan', 'Affiliation': 'Department of Medicine, Sidney Kimmel Medical College, Thomas Jefferson University Hospital, Philadelphia, PA (D.J.W.).'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Department of Medicine, University of Alberta, Canada (J.A.E.).'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Heart Diseases, Wrocław Medical University, Poland (P.P.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Internal Medicine, Saarland University, Homburg, Germany. (M.B.).'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and University of California San Francisco (J.R.T.).'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Heitner', 'Affiliation': 'Cytokinetics Inc, South San Francisco, CA (S.B.H., S.K., F.I.M., L.M.).'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Kupfer', 'Affiliation': 'Cytokinetics Inc, South San Francisco, CA (S.B.H., S.K., F.I.M., L.M.).'}, {'ForeName': 'Fady I', 'Initials': 'FI', 'LastName': 'Malik', 'Affiliation': 'Cytokinetics Inc, South San Francisco, CA (S.B.H., S.K., F.I.M., L.M.).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Cytokinetics Inc, South San Francisco, CA (S.B.H., S.K., F.I.M., L.M.).'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Division of Cardiology, School of Medicine, Duke University Medical Center, Durham, NC (G.M.F.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.121.008970']
3081,35236080,Capecitabine in the treatment of anal squamous cell carcinoma.,"BACKGROUND


Anal squamous cell carcinoma (ASCC) is a rare tumor; it accounts for about 2% of gastrointestinal tumors. The goal of the treatment is to preserve the anal sphincter and maintain the quality of life; surgical excision is therefore reserved only for very early stages and in vast majority of cases concomitant chemoradiotherapy (CRT) is indicated, i.e. pelvic irradiation and concomitant mitomycin-based chemotherapy. Technological development in the field of radiodia-gnostics, nuclear medicine and radiation therapy has improved the disease staging and enabled more gentle treatment. The standard regimen of chemotherapy has been based on the combination of mitomycin C (MMC) with 5-fluorouracil (5-FU) for many years, with high toxicity.
PURPOSE


The administration of 5-FU + capecitabine regimen provided an opportunity to reduce acute haematological toxicity. A prospective randomized phase II trial EXTRA demonstrated the oncological safety and good toxicity profile of oral capecitabine administered instead of 5-FU. The reduction of severe haematological toxicity and oncological non-inferiority of the capecitabine regimen was also demonstrated by other nine analyses presented in this article.
CONCLUSION


Most international guidelines published by societies such as the National Comprehensive Cancer Network, the European Society for Medical Oncology or the European Society for Therapeutic Radiology and Oncology have accepted capecitabine as a safe alternative to 5-FU in the treatment of ASCC and CRT regimen with oral capecitabine becoming the standard. The advantages are: proven excellent treatment results (non-inferiority towards standard regimens), significant reduction of various types of toxicity and the convenience of outpatient oral capecitabine.",2022,"The reduction of severe haematological toxicity and oncological non-inferiority of the capecitabine regimen was also demonstrated by other nine analyses presented in this article.
","['Anal squamous cell carcinoma (ASCC', 'anal squamous cell carcinoma']","['Capecitabine', '5-FU', 'mitomycin C (MMC) with 5-fluorouracil (5-FU', 'mitomycin-based chemotherapy', '5-FU + capecitabine', 'chemotherapy', 'oral capecitabine', 'capecitabine']","['oncological safety and good toxicity profile', 'severe haematological toxicity and oncological non-inferiority', 'acute haematological toxicity']","[{'cui': 'C0349534', 'cui_str': 'Carcinoma of anal margin'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.0198119,"The reduction of severe haematological toxicity and oncological non-inferiority of the capecitabine regimen was also demonstrated by other nine analyses presented in this article.
","[{'ForeName': 'Lohynská', 'Initials': 'L', 'LastName': 'Radka', 'Affiliation': ''}, {'ForeName': 'Pechačová', 'Initials': 'P', 'LastName': 'Zdeňka', 'Affiliation': ''}]",Klinicka onkologie : casopis Ceske a Slovenske onkologicke spolecnosti,['10.48095/ccko202238']
3082,35236066,[Role of total cryotherapy in combination with transcranial magnet therapy in the change of microcirculation and psychological status in patients with menopausal syndrome].,"One of the current health care problems is a menopausal syndrome (MS), a set of symptoms characterized by specific metabolic, neurological, autonomous, and psychosomatic changes. Many authors believe that one of the main methods of prevention and treatment of menopausal disorders is hormone replacement therapy, but there are many contraindications. Therefore, there is increasing interest in the development of non-medicinal therapy methods, in particular, physiotherapeutic treatment.
OBJECTIVE


To study the effect of total cryotherapy alone and in combination with transcranial magnet therapy on the microcirculation state and psychological status in patients with MS.
MATERIAL AND METHODS


The study included 62 female patients (mean age was 51±1.9 years). Thirty-five (56%) patients had mild menopausal syndrome and 27 (44%) moderate severity. All patients were divided into two clinically and functionally comparable groups by simple randomization: Group 1: 30 patients who received total cryotherapy (TCT); Group 2: 32 patients who received complex treatment including TCT and transcranial magnet therapy. The blood lipid spectrum was studied in all patients before and after the treatment course. The psychological examination was carried out using the well-being/activity/mood test (WAM). The microcirculation state was assessed by laser Doppler flowmetry (LDF).
RESULTS


The majority of the patients had abnormalities in the lipid spectrum, decreased psychological adaptation, and worsened microcirculation indices (according to LDF data). After a treatment course, improvement in the lipid spectrum, LDF, and WAM test scores according to all scales was more pronounced in group 2 patients receiving complex therapy.
CONCLUSION


The combined effect of total cryotherapy and transcranial magnet therapy had a more pronounced positive impact on the lipid spectrum, psychoemotional state, and microcirculatory processes in patients with menopausal syndrome compared with the total cryotherapy alone. It can be assumed that this complex will be effectively used in practical healthcare.",2022,"After a treatment course, improvement in the lipid spectrum, LDF, and WAM test scores according to all scales was more pronounced in group 2 patients receiving complex therapy.
","['patients with menopausal syndrome', '62 female patients (mean age was 51±1.9 years', 'patients with MS']","['total cryotherapy alone and in combination with transcranial magnet therapy', 'transcranial magnet therapy', 'total cryotherapy', 'total cryotherapy and transcranial magnet therapy', 'complex treatment including TCT and transcranial magnet therapy', 'total cryotherapy (TCT']","['psychological adaptation, and worsened microcirculation indices', 'mild menopausal syndrome', 'lipid spectrum, psychoemotional state, and microcirculatory processes', 'microcirculation state and psychological status', 'lipid spectrum, LDF, and WAM test scores', 'microcirculation state', 'microcirculation and psychological status', 'blood lipid spectrum']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025319', 'cui_str': 'Menopausal syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0024483', 'cui_str': 'Magnet'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0683269', 'cui_str': 'Psychological Adaptation'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0025319', 'cui_str': 'Menopausal syndrome'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0162520', 'cui_str': 'Laser doppler flowmetry'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",62.0,0.0215214,"After a treatment course, improvement in the lipid spectrum, LDF, and WAM test scores according to all scales was more pronounced in group 2 patients receiving complex therapy.
","[{'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Fesyun', 'Affiliation': 'National Medical Research Center for Medical Rehabilitation and Balneology, Moscow, Russia.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Kulchitskaya', 'Affiliation': 'National Medical Research Center for Medical Rehabilitation and Balneology, Moscow, Russia.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Konchugova', 'Affiliation': 'National Medical Research Center for Medical Rehabilitation and Balneology, Moscow, Russia.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Yurova', 'Affiliation': 'National Medical Research Center for Medical Rehabilitation and Balneology, Moscow, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Gushchina', 'Affiliation': 'National Medical Research Center for Medical Rehabilitation and Balneology, Moscow, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Kotenko', 'Affiliation': 'National Medical Research Center for Medical Rehabilitation and Balneology, Moscow, Russia.'}, {'ForeName': 'O O', 'Initials': 'OO', 'LastName': 'Borisevich', 'Affiliation': 'National Medical Research Center for Medical Rehabilitation and Balneology, Moscow, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20229901150']
3083,35236065,[Effect of iodine-bromine baths on stress-systems indicators in children with autism spectrum disorders].,"The continuous increase in the prevalence of autism spectrum disorders (ASD) in the population, the debatable nature of many aspects of etiology, pathogenesis, and treatment of these disorders justify the urgent need for the development of effective medical rehabilitation methods affecting the pathogenetic mechanisms.Exposure of children with ASD to external stimuli in excessive force often leads to the stress-systems response not corresponding to the compensation abilities of the body.
OBJECTIVE


To evaluate the effect of iodine-bromine baths on stress-system indicators in children with ASD.
MATERIAL AND METHODS


The study involved 74 children with ASD (F84) aged 3 to 14 years (mean age 6.23±0.37 years) included in the main group (MG). The control group (CG) consisted of 25 healthy children.The examination included detailed history taking, examination by specialists, assessment of disease severity using CARS scale, evaluation of β-endorphin, adrenocorticotropic hormone (ACTH), and cortisol levels in blood serum by ELISA.  Thirty-four (45.9%) children had a moderate autism level (total score 30-37), and 40 (54.1%) children had severe autism (total score 37-60). In the MG, there were 27 (36.5%) children with mild symptoms of hyperactivity (subgroup A) and 47 (63.5%) children with severe aggression, tantrums, and increased hyperactivity (subgroup B). All MG patients were assigned into two subgroups by randomization: Subgroup 1: 30 children with ASD received health resort treatment (HRT) without iodine-bromine baths (IB); Subgroup 2: 44 children with ASD received similar HRT and IB.
RESULTS


Statistically significant increase of β-endorphin, ACTH and cortisol levels ( p <0.01,  p <0.05,  p <0.01, respectively) in children with ASD (compared to those in CG children) was identified. In children without hyperactivity, a moderate increase of these parameters was noted; significantly higher values were observed in children with severe hyperactivity, impulsiveness, and aggression ( p <0.05,  p <0.001, respectively). After treatment, there was a statistically significant increase in β-endorphin level in subgroup 1 children who received HRT without IB, while in children of subgroups A and B ( p <0.05,  p <0.05,  p <0.01, respectively), there was a decrease in ACTH level ( p <0.05,  p <0.01,  p <0.001 respectively) and a trend towards a cortisol level decrease. Inclusion of IB in HRT course associated with a significant decrease of β-endorphin level in children of subgroups A and B ( p <0.001), a decrease of ACTH level ( p <0.001) and cortisol ( p <0.001,  p <0.01,  p <0.001, respectively), which resulted in vicious circle breaking and normalization of relations between stress-limiting and stress-releasing parts of pathogenesis.
CONCLUSION


Most children with autism spectrum disorders showed significant increases in β-endorphin, adrenocorticotropic hormone, and cortisol levels, indicating dysfunction between the stress-limiting and stress-releasing systems, as well as between the central and peripheral parts of the stress-releasing chain. The tonic effect of resort treatment was noted, limiting its use in children with autism spectrum disorders, increased hyperactivity, and aggression. The inclusion of iodine-bromine baths in resort treatment has a calming non-medicinal effect and can be recommended for use in children with symptoms of severe hyperactivity.",2022,"Most children with autism spectrum disorders showed significant increases in β-endorphin, adrenocorticotropic hormone, and cortisol levels, indicating dysfunction between the stress-limiting and stress-releasing systems, as well as between the central and peripheral parts of the stress-releasing chain.","['25 healthy children', 'Thirty-four (45.9%) children had a moderate autism level (total score 30-37), and 40 (54.1%) children had severe autism (total score 37-60', 'children with autism spectrum disorders', 'children with ASD', 'children with symptoms of severe hyperactivity', '74 children with ASD (F84) aged 3 to 14 years (mean age 6.23±0.37 years) included in the main group (MG', '30 children with ASD received', '27 (36.5%) children with mild symptoms of hyperactivity (subgroup A) and 47 (63.5%) children with severe aggression, tantrums, and increased hyperactivity (subgroup B', 'Subgroup 2: 44 children with ASD received']","['health resort treatment (HRT) without iodine-bromine baths (IB', 'iodine-bromine baths', 'similar HRT and IB']","['disease severity using CARS scale, evaluation of β-endorphin, adrenocorticotropic hormone (ACTH), and cortisol levels in blood serum by ELISA', 'β-endorphin, ACTH and cortisol levels', 'β-endorphin level', 'stress-systems indicators', 'ACTH level', 'hyperactivity, and aggression', 'severe hyperactivity, impulsiveness, and aggression', 'β-endorphin, adrenocorticotropic hormone, and cortisol levels']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0436343', 'cui_str': 'Symptom mild'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0233558', 'cui_str': 'Temper tantrum'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C0018740', 'cui_str': 'Health Resorts'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0006223', 'cui_str': 'Bromine'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0014242', 'cui_str': 'Endorphin'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}]",74.0,0.0292921,"Most children with autism spectrum disorders showed significant increases in β-endorphin, adrenocorticotropic hormone, and cortisol levels, indicating dysfunction between the stress-limiting and stress-releasing systems, as well as between the central and peripheral parts of the stress-releasing chain.","[{'ForeName': 'T F', 'Initials': 'TF', 'LastName': 'Golubova', 'Affiliation': ""Research Institute of Children's Resorts, Physiotherapy and Medical Rehabilitation, Yevpatoria, Russia.""}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Nuvoli', 'Affiliation': ""Research Institute of Children's Resorts, Physiotherapy and Medical Rehabilitation, Yevpatoria, Russia.""}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20229901142']
3084,35236433,"Proximal fibular resection improves knee biomechanics and enhances tibial stress fracture healing in patients with osteoarthritis with varus deformity: a prospective, randomized control analysis.","BACKGROUND


The present study aimed to evaluate the functional outcome of single-stage total knee arthroplasty using long-stem tibial component with proximal fibular resection (PFR) for patients with knee osteoarthritis with varus deformity associated with tibial stress fracture.
METHOD


A cohort of 62 patients with a mean age 71.63 ± 7.40 years who met the criteria were randomized to a study group and a control group. Patients in the study group underwent single-stage total knee arthroplasty using long-stem tibial component with PFR. The control group received conventional treatment. All patients were followed at 1, 3, 6 and 12 month(s) after surgery. Standard anteroposterior and lateral weight bearing knee X-rays were analyzed. Western Ontario and Mc-master Universities Osteoarthritis Index score (WOMAC) and the visual analog scale (VAS) score were used to assess the functional outcome. The level of significance was set at p < 0.05 levels.
RESULTS


One patient in the study group was lost to follow-up, leaving 61 patients for final assessment. The WOMAC total score and mean VAS score were significantly better in study group than in control group at final follow-up (p < 0.05). All fractures were successfully united in a mean time of 12.26 ± 1.20 weeks in study group. A total of 16 patients in control group had delayed union, five had established nonunion and required further interventions. No complications relating to surgery was detected.
CONCLUSION


Total knee arthroplasty with PFR for knee arthritis with varus deformity associated with tibial stress fractures restores limb alignment, improves biomechanics, enhances fracture healing and provides excellent functional outcome.",2020,The WOMAC total score and mean VAS score were significantly better in study group than in control group at final follow-up (p < 0.05).,"['62 patients with a mean age 71.63\u2009±\u20097.40\u2009years who met the criteria', 'patients with knee osteoarthritis with varus deformity associated with tibial stress fracture', 'patients with osteoarthritis with varus deformity', '16 patients in control group had delayed union, five had established nonunion and required further interventions']","['single-stage total knee arthroplasty using long-stem tibial component with PFR', 'conventional treatment', 'Proximal fibular resection', 'single-stage total knee arthroplasty using long-stem tibial component with proximal fibular resection (PFR']","['WOMAC total score and mean VAS score', 'Western Ontario and Mc-master Universities Osteoarthritis Index score (WOMAC) and the visual analog scale (VAS) score', 'tibial stress fracture healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0432593', 'cui_str': 'Varus angulation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0016664', 'cui_str': 'Stress fracture'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0016664', 'cui_str': 'Stress fracture'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",62.0,0.0462565,The WOMAC total score and mean VAS score were significantly better in study group than in control group at final follow-up (p < 0.05).,"[{'ForeName': 'Vikram Indrajit', 'Initials': 'VI', 'LastName': 'Shah', 'Affiliation': 'Department of Knee and Hip Arthroplasty, Shalby Hospitals, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Upadhyay', 'Affiliation': 'Department of Orthopaedics, NSCB Medical College, Jabalpur, MP, India. drsachinupadhyay@gmail.com.'}, {'ForeName': 'Kalpesh', 'Initials': 'K', 'LastName': 'Shah', 'Affiliation': 'Department of Knee and Hip Arthroplasty, Shalby Hospitals, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sheth', 'Affiliation': 'Department of Knee and Hip Arthroplasty, Shalby Hospitals, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Amish', 'Initials': 'A', 'LastName': 'Kshatriya', 'Affiliation': 'Department of Knee and Hip Arthroplasty, Shalby Hospitals, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Jayesh', 'Initials': 'J', 'LastName': 'Patil', 'Affiliation': 'Department of Knee and Hip Arthroplasty, Shalby Hospitals, Ahmedabad, Gujarat, India.'}]","Arthroplasty (London, England)",['10.1186/s42836-020-00030-y']
3085,35236432,MRI-based or CT-based patient-specific instrumentation in Total knee Arthroplasty: How do the two systems compare?,"BACKGROUND


Patient-specific instrumentation (PSI) has been introduced into total knee arthroplasty (TKA) to improve accuracy in restoration of alignment. PSI in TKA refers to custom-made cutting jigs manufactured according to anatomic configuration of the patient's bone based on preoperative magnetic resonance imaging (MRI) or computed tomography (CT) scans. The purpose of this study was to compare the MRI- or CT-based PSI to see if they could reproduce accurate bone resection and postoperative outcomes.
METHODS


Seventy-one patients who received elective TKA using a PSI system for primary osteoarthritis with varus deformity were prospectively enrolled for this study. We randomly allocated those patients to MRI-based PSI group (36 patients) and CT-based PSI group (35 patients). The actual resection thickness and planned resection thickness by preoperative PSI electronic program were compared between the two groups. Radiographic findings of the postoperative limb alignment, three-dimensional position of the implants, and related complications were also evaluated. Clinical evaluation was also performed before and 2 years after the surgery.
RESULTS


There were no significant differences in the resection thickness in femur and tibia between actual resection and planned resection in both groups. Furthermore, there were no significant differences between two groups in terms of coronal, sagittal and rotational alignment of the components. All clinical assessments revealed no differences between two groups 2 years after the operation. No specific complication related to PSI was observed.
CONCLUSIONS


Although MRI allows for visualization of cartilage, MRI-based PSI system did not show better accuracy in predicting the thickness of bone resection than CT-based PSI. Moreover, there were no differences in radiographic and clinical outcomes between the two groups.",2020,There were no significant differences in the resection thickness in femur and tibia between actual resection and planned resection in both groups.,"['Total knee Arthroplasty', 'Seventy-one patients who received elective TKA using a PSI system for primary osteoarthritis with varus deformity']","['CT-based PSI', 'specific instrumentation (PSI', 'MRI-based PSI', 'preoperative PSI electronic program', 'MRI-based or CT-based patient-specific instrumentation']","['actual resection thickness and planned resection thickness', 'resection thickness in femur and tibia between actual resection and planned resection', 'radiographic and clinical outcomes']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0409952', 'cui_str': 'Idiopathic osteoarthritis'}, {'cui': 'C0432593', 'cui_str': 'Varus angulation'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",71.0,0.127359,There were no significant differences in the resection thickness in femur and tibia between actual resection and planned resection in both groups.,"[{'ForeName': 'Dong-Geun', 'Initials': 'DG', 'LastName': 'Kang', 'Affiliation': 'Department of Orthopaedic Surgery, Kyung Hee University Hospital at Gangdong, 892 Dongnam-ro, Gangdong-gu, Seoul, 134-727, South Korea.'}, {'ForeName': 'Kang-Il', 'Initials': 'KI', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Kyung Hee University Hospital at Gangdong, 892 Dongnam-ro, Gangdong-gu, Seoul, 134-727, South Korea. khuknee@gmail.com.'}, {'ForeName': 'Jung-Kwon', 'Initials': 'JK', 'LastName': 'Bae', 'Affiliation': 'Department of Orthopaedic Surgery, Kyung Hee University Hospital at Gangdong, 892 Dongnam-ro, Gangdong-gu, Seoul, 134-727, South Korea.'}]","Arthroplasty (London, England)",['10.1186/s42836-019-0020-6']
3086,35236423,Efficacy of low-fat milk and yogurt fortified with vitamin D 3  on systemic inflammation in adults with abdominal obesity.,"BACKGROUND


The prevalence of vitamin D deficiency is increasing globally and is associated with an increased risk of metabolic syndrome, autoimmune disease, and cardiovascular disease. Vit D deficiency is also associated with increased systemic inflammation. The current study aimed to determine the efficacy of low-fat milk and yogurt fortified with 1500 IU nano-encapsulated vitamin D, on systemic inflammation in abdominal obese participants.
METHOD


This multi-center study was conducted using a 2.5-month parallel total-blind randomized clinical trial design. Two hundred and eighty nine subjects were allocated to four groups: low-fat milk fortified by 1500 IU nano-encapsulated vitamin D 3  (200 mL/day). Simple milk (200 mL/day), low-fat yogurt fortified by 1500 IU nano-encapsulated vitamin D 3  (150 g/day), and simple yogurt (150 g/day).
RESULTS


The results showed that serum levels of neutrophils, lymphocytes, platelets and red blood cell distribution width (RDW) were significantly lower before and after the intervention in fortified dairy groups. The results showed that serum levels of neutrophils, lymphocytes, platelets, and RDW before and after intervention in the fortified dairy groups were significantly lower (p < 0.05). The values of = neutrophil to lymphocyte ratio (NLR), platelets to lymphocyte ratio, and RDW to platelets ratio (RPR) reduced significantly in the fortification group (p < 0.05).
CONCLUSION


Fortification with nano-encapsulated vitamin D 3  of dairy products may decrease inflammation in individuals with abdominal obesity.",2022,"The results showed that serum levels of neutrophils, lymphocytes, platelets and red blood cell distribution width (RDW) were significantly lower before and after the intervention in fortified dairy groups.","['individuals with abdominal obesity', 'adults with abdominal obesity', 'abdominal obese participants', 'Two hundred and eighty nine subjects']","['low-fat milk and yogurt fortified with vitamin D 3', 'low-fat milk fortified by 1500\xa0IU nano-encapsulated vitamin D 3', 'low-fat milk and yogurt fortified with 1500\xa0IU nano-encapsulated vitamin D']","['systemic inflammation', 'serum levels of neutrophils, lymphocytes, platelets, and RDW', 'serum levels of neutrophils, lymphocytes, platelets and red blood cell distribution width (RDW', 'values of\u2009=\u2009neutrophil to lymphocyte ratio (NLR), platelets to lymphocyte ratio, and RDW to platelets ratio (RPR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0349375', 'cui_str': 'Skim milk'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0427460', 'cui_str': 'Red cell distribution width determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",289.0,0.177517,"The results showed that serum levels of neutrophils, lymphocytes, platelets and red blood cell distribution width (RDW) were significantly lower before and after the intervention in fortified dairy groups.","[{'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Sharifan', 'Affiliation': 'Student Research Committee, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rashidmayvan', 'Affiliation': 'Department of Nutrition, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Khorasanchi', 'Affiliation': 'Student Research Committee, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Darroudi', 'Affiliation': 'International UNESCO Center for Health Related Basic Sciences and Human Nutrition, Mashhad University of Medical Sciences, 99199-91766, Mashhad, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Heidari', 'Affiliation': 'Department of Nutrition Sciences, Varastegan Institute for Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hoseinpoor', 'Affiliation': 'Department of Nutrition Sciences, Varastegan Institute for Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Vatanparast', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Safarian', 'Affiliation': 'Department of Nutrition, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Eslami', 'Affiliation': 'Department of Medical Informatics, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Afshari', 'Affiliation': 'Department of Nutrition, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Asadi', 'Affiliation': 'International UNESCO Center for Health Related Basic Sciences and Human Nutrition, Mashhad University of Medical Sciences, 99199-91766, Mashhad, Iran.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Ghazizadeh', 'Affiliation': 'Student Research Committee, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bagherniya', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Khedmatgozar', 'Affiliation': 'Department of Nutrition, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Ferns', 'Affiliation': 'Division of Medical Education, Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Rezaie', 'Affiliation': 'Department of Nutrition, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. rezaeim1@mums.ac.ir.'}, {'ForeName': 'Majid Ghayour', 'Initials': 'MG', 'LastName': 'Mobarhan', 'Affiliation': 'Department of Nutrition, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. ghayourm@mums.ac.ir.'}]","Journal of health, population, and nutrition",['10.1186/s41043-022-00283-0']
3087,35236410,"Development and application of ""Special defibrillator for teaching and training"".","BACKGROUND


To provide an economical and practical defibrillator for first aid teaching and training, to reduce the cost of teaching and training, increase teaching and training equipment, provide trainees with more hands-on training sessions, and improve first aid capabilities.
METHODS


Developing a special teaching defibrillator with the same structure and operation configuration as the clinical medical emergency defibrillator. The appearance, structure and operating accessories of the two defibrillators are the same. The difference between the defibrillator and the clinical medical emergency defibrillator are as follows: the clinical medical emergency defibrillator can be energized, and there are expensive electronic accessories and defibrillation accessories for charging and discharging in the machine. When discharging, the electrode plate has current discharged into the human body; the power plug of the ""special defibrillator for teaching and training"" is a fake plug. When the power is plugged in, no current enters the body and the machine. There are no expensive electronic accessories and defibrillation accessories for charging and discharging, and no current is discharged during discharge. Then compare the teaching effect of the special defibrillator for teaching and training and the clinical medical emergency defibrillator (including operation score and attitude after training).
RESULTS


The scores of defibrillator operation in the experimental group of junior college students (87.77 ± 4.11 vs. 83.30 ± 4.56, P < 0.001) and the experimental group of undergraduate students (90.40 ± 3.67 vs. 89.12 ± 3.68, P = 0.011) were higher than those in the corresponding control group; The attitude of junior college students in the experimental group and undergraduate students in the experimental group after training was more positive than that of the corresponding control group (P < 0.05).
CONCLUSIONS


The special defibrillator for teaching and training can save the purchase cost of teaching equipment, increase teaching and training resources, and improve the trainee's defibrillation ability, defibrillation confidence and defibrillation security.",2022,"The special defibrillator for teaching and training can save the purchase cost of teaching equipment, increase teaching and training resources, and improve the trainee's defibrillation ability, defibrillation confidence and defibrillation security.",[],[],['scores of defibrillator operation'],[],[],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",,0.0301463,"The special defibrillator for teaching and training can save the purchase cost of teaching equipment, increase teaching and training resources, and improve the trainee's defibrillation ability, defibrillation confidence and defibrillation security.","[{'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Xing', 'Affiliation': 'Department of Critical Care, The First Affiliated Hospital of Gannan Medical University, No. 123 Jinling Avenue, Zhanggong District, Jiangxi, 341000, China.'}, {'ForeName': 'Shujing', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Nursing, Gannan Health Vocational College, Jiangxi, 341000, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': 'Department of Breast Disease Prevention and Control Center, Guangdong Women and Children Hospital, Guangdong, 511400, China.'}, {'ForeName': 'Zhisheng', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Department of Critical Care, The First Affiliated Hospital of Gannan Medical University, No. 123 Jinling Avenue, Zhanggong District, Jiangxi, 341000, China.'}, {'ForeName': 'Fengzhen', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Critical Care, The First Affiliated Hospital of Gannan Medical University, No. 123 Jinling Avenue, Zhanggong District, Jiangxi, 341000, China.'}, {'ForeName': 'Zhiyou', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care, The First Affiliated Hospital of Gannan Medical University, No. 123 Jinling Avenue, Zhanggong District, Jiangxi, 341000, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Nie', 'Affiliation': 'Department of Cardiac Intervention Room, The First Affiliated Hospital of Gannan Medical University, Jiangxi, 341000, China.'}, {'ForeName': 'Hongying', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Critical Care, The First Affiliated Hospital of Gannan Medical University, No. 123 Jinling Avenue, Zhanggong District, Jiangxi, 341000, China. zhaosj_2021@163.com.'}]",European journal of medical research,['10.1186/s40001-022-00657-4']
3088,35238476,Pharmacokinetics/pharmacodynamics of L-ornithine phenylacetate in overt hepatic encephalopathy and the effect of plasma ammonia concentration reduction on clinical outcomes.,"Hepatic encephalopathy (HE) is a serious neurocognitive complication of liver dysfunction, often associated with elevated plasma ammonia. Ornithine phenylacetate (OP), a potent ammonia scavenger, is being evaluated for the treatment of acute/overt HE. The pharmacokinetics and pharmacodynamics of OP in patients with HE were characterized in this phase IIb study (NCT01966419). Adult patients hospitalized with an overt HE episode, cirrhosis, and plasma ammonia above the upper limit of normal (ULN) who failed to improve after 48 hours' standard care were randomly assigned to continuous intravenous OP (10, 15, or 20 g/day, based on Child-Turcotte-Pugh score) or matching placebo for 5 days. Plasma levels of ornithine and phenylacetic acid (PAA) and plasma/urinary levels of phenylacetylglutamine (PAGN) (primary metabolite of PAA) were regularly assessed; plasma ammonia level was the primary pharmacodynamic variable. PAA demonstrated dose-dependent pharmacokinetics; ornithine and PAGN levels increased with dose. PAGN urinary excretion represented ~50%-60% of administered PAA across all doses. Mean reduction in plasma ammonia with OP at 3 hours postinfusion was significantly greater versus placebo (p = 0.014); and time to achieve plasma ammonia less than or equal to the ULN was significantly reduced (p = 0.028). Achievement of clinical response based on HE stage was associated with a greater reduction in mean plasma ammonia level (p = 0.009). OP effects on plasma ammonia were consistent with its proposed mechanism of action as a primary ammonia scavenger, with a significant association between reduced plasma ammonia and improvement in HE stage. OP should be further evaluated as a promising treatment for hyperammonemia in patients with overt HE.",2022,Achievement of clinical response based on HE stage was associated with a greater reduction in mean plasma ammonia level (p = 0.009).,"[""Adult patients hospitalized with an overt HE episode, cirrhosis, and plasma ammonia above the upper limit of normal (ULN) who failed to improve after 48\xa0hours' standard care"", 'patients with overt HE', 'patients with HE']","['continuous intravenous OP', 'Ornithine phenylacetate (OP', 'placebo', 'L-ornithine phenylacetate']","['PAGN urinary excretion', 'plasma ammonia level', 'plasma ammonia and improvement in HE stage', 'pharmacokinetics and pharmacodynamics of OP', 'mean plasma ammonia level', 'plasma ammonia', 'Mean reduction in plasma ammonia with OP', 'time to achieve plasma ammonia less', 'Plasma levels of ornithine and phenylacetic acid (PAA) and plasma/urinary levels of phenylacetylglutamine (PAGN) (primary metabolite of PAA', 'PAGN levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C1278131', 'cui_str': 'Plasma ammonia measurement'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3492240', 'cui_str': 'ornithine phenylacetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0887117', 'cui_str': 'Ornithine, (L)-Isomer'}, {'cui': 'C0031452', 'cui_str': 'Benzeneacetates'}]","[{'cui': 'C0070627', 'cui_str': 'phenylacetylglutamine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C1278131', 'cui_str': 'Plasma ammonia measurement'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C3492240', 'cui_str': 'ornithine phenylacetate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029277', 'cui_str': 'Ornithine'}, {'cui': 'C0070620', 'cui_str': 'Phenylacetic acid'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.150107,Achievement of clinical response based on HE stage was associated with a greater reduction in mean plasma ammonia level (p = 0.009).,"[{'ForeName': 'Rifaat', 'Initials': 'R', 'LastName': 'Safadi', 'Affiliation': 'Director of The Liver Institute, Hadassah Medical Organization, Hadassah Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Rahimi', 'Affiliation': 'Baylor Scott and White Hospital, Baylor University Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Thabut', 'Affiliation': 'Brain Liver Pitié-Salpêtrière (B-LIPS) Study Group, Paris Sorbonne Université, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Jasmohan S', 'Initials': 'JS', 'LastName': 'Bajaj', 'Affiliation': 'Department of Medicine, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Kalyan', 'Initials': 'K', 'LastName': 'Ram Bhamidimarri', 'Affiliation': 'Miller School of Medicine, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Pyrsopoulos', 'Affiliation': 'Rutgers New Jersey Medical School and University Hospital, Newark, New Jersey, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Potthoff', 'Affiliation': 'Ocera Therapeutics, Inc., Redwood City, California, USA.'}, {'ForeName': 'Stan', 'Initials': 'S', 'LastName': 'Bukofzer', 'Affiliation': 'Ocera Therapeutics, Inc., Redwood City, California, USA.'}, {'ForeName': 'Laurene', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'INDAPharma, LLC, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Khurram', 'Initials': 'K', 'LastName': 'Jamil', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Hampton, New Jersey, USA.'}, {'ForeName': 'Krishna R', 'Initials': 'KR', 'LastName': 'Devarakonda', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Webster Groves, Missouri, USA.'}]",Clinical and translational science,['10.1111/cts.13257']
3089,35238940,"Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial.","BACKGROUND


The effects of the sodium-glucose co-transporter-2 inhibitor empagliflozin on renal and cardiovascular disease have not been tested in a dedicated population of people with chronic kidney disease (CKD).
METHODS


The EMPA-KIDNEY trial is an international randomized, double-blind, placebo-controlled trial assessing whether empagliflozin 10 mg daily reduces risk of kidney disease progression or cardiovascular death in people with CKD. People with or without diabetes mellitus (DM) were eligible provided they had: (i) an estimated glomerular filtration rate (eGFR) ≥20, <45 mL/min/1.73m2;  or (ii) an eGFR ≥ 45, <90 mL/min/1.73m2 with a urinary albumin: creatinine ratio (uACR) ≥200 mg/g. The trial design is streamlined: extra work for collaborating sites is kept to a minimum, and only essential information is collected.
RESULTS


Between 15 May 2019 and 16 April 2021, 6609 people from eight countries in Europe, North America and East Asia were randomized. Mean age at randomization was 63.8 (SD 13.9) years, 2192 (33%) were female, and 3570 (54%) had no prior history of DM. Mean eGFR was 37.5 (14.8) mL/min/1.73m2, including 5185 (78%) with an eGFR < 45 mL/min/1.73m2. Median (Q1-Q3) uACR was 412 (94-1190) mg/g, with a uACR < 300 mg/g in 3194 (48%). The causes of kidney disease included diabetic kidney disease (n = 2057 [31%]), glomerular disease (n = 1669 [25%]), hypertensive/renovascular disease (n = 1445 [22%]), other (n = 808 [12%]), and unknown causes (n = 630 [10%]).
CONCLUSIONS


EMPA-KIDNEY will evaluate the efficacy and safety of empagliflozin in a widely generalizable population of people with CKD at risk of kidney disease progression. Results are anticipated in 2022.",2022,Median (Q1-Q3) uACR was 412,"['people with CKD', 'people with chronic kidney disease (CKD', 'kidney disease included diabetic kidney disease (n\xa0', 'Between 15 May 2019 and 16 April 2021, 6609 people from eight countries in Europe, North America and East Asia were randomized', 'People with or without diabetes mellitus (DM) were eligible provided they had', 'Mean age at randomization was 63.8 (SD 13.9) years, 2192 (33%) were female, and 3570 (54%) had no prior history of DM']","['sodium-glucose co-transporter-2 inhibitor empagliflozin', 'empagliflozin', 'placebo']","['hypertensive/renovascular disease', 'urinary albumin: creatinine ratio (uACR) ≥200', 'risk of kidney disease progression or cardiovascular death', 'glomerular disease', 'Median (Q1-Q3) uACR', 'efficacy and safety', 'Mean eGFR', 'glomerular filtration rate (eGFR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015631', 'cui_str': 'Far east country'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0455488', 'cui_str': 'H/O: diabetes mellitus'}]","[{'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0268790', 'cui_str': 'Renal vascular disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0268731', 'cui_str': 'Glomerular disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",6609.0,0.242697,Median (Q1-Q3) uACR was 412,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfac040']
3090,35238917,The Effect of Topical Anesthetics on 16S Ribosomal Ribonucleic Acid Amplicon Sequencing Results in Ocular Surface Microbiome Research.,"Purpose


To clarify the short-term effect of topical anesthetics on 16S ribosomal ribonucleic acid amplicon sequencing results in ocular surface microbiome research.
Methods


Both eyes of 24 eligible volunteers undergoing general anesthesia were sampled. Before sampling, a drop of artificial tears or a drop of topical anesthetic was applied in a randomized way. By using artificial tears as a control, we assured blinding of the executer and took a potential diluting effect into account. Bacterial DNA was extracted using the QIAGEN RNeasy PowerMicrobiome Kit with specific adaptations. Amplified DNA was sequenced with the Illumina MiSeq sequencing platform.
Results


Four sample pairs were excluded due to low yield of bacterial DNA. In the remaining 20 sample pairs, no differences were observed with topical anesthetics at the levels of amplicon sequence variants (ASVs), phylum, genera, or alpha and beta diversity. Weighted UniFrac distance confirmed that the intraindividual distance between the right and left eye was smaller than the effect of the topical anesthetic. Interestingly, however, we identified Cutibacterium as a potential discriminative biomarker for topical anesthetic use. Overall, a significantly higher number of observed reads were assigned to genera with Gram-positive characteristics.
Conclusions


Based on our targeted, double-blinded, within-subject study, topical anesthetics do not affect the overall sequencing results but display a specific effect on Cutibacterium. When comparing research results, the impact of topical anesthetics on prevalence and abundance of Cutibacterium should be considered.
Translational Relevance


Understanding and standardization of sampling techniques are indispensable to properly execute clinical microbiome research.",2022,"In the remaining 20 sample pairs, no differences were observed with topical anesthetics at the levels of amplicon sequence variants (ASVs), phylum, genera, or alpha and beta diversity.",['24 eligible volunteers undergoing general anesthesia were sampled'],"['topical anesthetics', 'Topical Anesthetics']","['levels of amplicon sequence variants (ASVs), phylum, genera, or alpha and beta diversity']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}]",24.0,0.109823,"In the remaining 20 sample pairs, no differences were observed with topical anesthetics at the levels of amplicon sequence variants (ASVs), phylum, genera, or alpha and beta diversity.","[{'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Delbeke', 'Affiliation': 'Department of Ophthalmology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Ingele', 'Initials': 'I', 'LastName': 'Casteels', 'Affiliation': 'Department of Ophthalmology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Joossens', 'Affiliation': 'Department of Biochemistry and Microbiology, Ghent University, Ghent, Belgium.'}]",Translational vision science & technology,['10.1167/tvst.11.3.2']
3091,35238902,Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical Trial.,"Importance


AGN-190584 (Allergan, an AbbVie company) is an optimized topical formulation of pilocarpine hydrochloride, 1.25%, designed for managing presbyopia and enhanced with a proprietary vehicle.
Objective


To evaluate the efficacy and safety of pilocarpine hydrochloride, 1.25%, in individuals with presbyopia.
Design, Setting, and Participants


This vehicle-controlled, participant- and investigator-masked, randomized, phase 3 clinical study, GEMINI 1, enrolled individuals with presbyopia, aged 40 to 55 years, at 36 sites in the United States from December 21, 2018, to October 31, 2019. Analysis took place between February 2020 and December 2021.
Interventions


AGN-190584 or the AGN-190584 formulation vehicle was administered bilaterally, once daily for 30 days.
Main Outcomes and Measures


The proportion of participants with improvement of 3 or more lines in mesopic, high-contrast, binocular distance-corrected near visual acuity (DCNVA) at hours 3 and 6 on day 30 were the primary and key secondary efficacy end points, respectively. Safety measures included adverse events.
Results


Of 323 participants who were randomized, 235 (72.8%) were female and 292 (90.4%) were White. The mean (SD) age was 49.6 (3.5) years, and the baseline mean (SD) mesopic DCNVA was 29.2 (6.3) letters. A total of 163 individuals were randomized to AGN-190584 and 160 were randomized to vehicle. GEMINI 1 met its primary and key secondary efficacy end points. On day 30, hour 3, the percentage of participants with improvement of 3 or more lines in mesopic DCNVA was 30.7% (50 of 163) in the AGN-190584 group and 8.1% (13 of 160) in the vehicle group (difference, 22.5% [95% CI, 14.3%-30.8%]; adjusted P < .001). At hour 6, those percentages were 18.4% (30 of 163) and 8.8% (14 of 160), respectively (difference, 9.7% [95% CI, 2.3%-17.0%]; adjusted P = .01). At hour 8, the between-group difference in 3 or more lines of mesopic DCNVA gains was not statistically significant, but clinically relevant prespecified outcome measures demonstrated AGN-190584 superiority to vehicle in least-squares mean (SE) mesopic DCNVA change from baseline at hour 8 (5.4 [0.51] vs 3.6 [0.52] letters; P = .009) and photopic distance-corrected intermediate visual acuity at hour 8 (3.9 [0.44] vs 2.4 [0.45] letters; P = .01) and hour 10 (3.5 [0.46] vs 1.7 [0.47] letters; P = .004). No participants with mesopic DCNVA improvement of 3 or more lines at hour 3 had losses of more than 5 letters in mesopic, high-contrast, binocular-corrected distance visual acuity. The onset of effect was at 15 minutes. AGN-190584 demonstrated an acceptable safety and tolerability profile.
Conclusions and Relevance


AGN-190584 demonstrated superiority over vehicle in mesopic DCNVA on day 30, hours 3 and 6, with an acceptable safety profile. AGN-190584 is a safe and efficacious topical therapy for presbyopia through 30 days.
Trial Registration


ClinicalTrials.gov Identifier: NCT03804268.",2022,"No participants with mesopic DCNVA improvement of 3 or more lines at hour 3 had losses of more than 5 letters in mesopic, high-contrast, binocular-corrected distance visual acuity.","['individuals with presbyopia', 'A total of 163 individuals', 'Individuals With Presbyopia', '323 participants who were randomized, 235 (72.8%) were female and 292 (90.4%) were White', 'enrolled individuals with presbyopia, aged 40 to 55 years, at 36 sites in the United States from December 21, 2018, to October 31, 2019']","['AGN-190584', 'pilocarpine hydrochloride']","['Safety and Efficacy', 'acceptable safety and tolerability profile', 'AGN-190584 superiority to vehicle in least-squares mean (SE) mesopic DCNVA change', 'mesopic DCNVA improvement of 3 or more lines at hour 3 had losses of more than 5 letters in mesopic, high-contrast, binocular-corrected distance visual acuity', 'mesopic DCNVA', 'mesopic DCNVA gains', 'proportion of participants with improvement of 3 or more lines in mesopic, high-contrast, binocular distance-corrected near visual acuity (DCNVA', 'adverse events', 'efficacy and safety', 'photopic distance-corrected intermediate visual acuity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033075', 'cui_str': 'Presbyopia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0770456', 'cui_str': 'Pilocarpine hydrochloride'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}]",163.0,0.675973,"No participants with mesopic DCNVA improvement of 3 or more lines at hour 3 had losses of more than 5 letters in mesopic, high-contrast, binocular-corrected distance visual acuity.","[{'ForeName': 'George O', 'Initials': 'GO', 'LastName': 'Waring', 'Affiliation': 'Waring Vision Institute, Mt Pleasant, South Carolina.'}, {'ForeName': 'Francis W', 'Initials': 'FW', 'LastName': 'Price', 'Affiliation': 'Price Vision Group, Indianapolis, Indiana.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wirta', 'Affiliation': 'Eye Research Foundation, Newport Beach, California.'}, {'ForeName': 'Cathleen', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': 'The Eye Associates, Bradenton, Florida.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Moshirfar', 'Affiliation': 'Hoopes Vision Research Center, Draper, Utah.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'AbbVie Inc, Irvine, California.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Gore', 'Affiliation': 'AbbVie Inc, Irvine, California.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'AbbVie Inc, Irvine, California.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Safyan', 'Affiliation': 'AbbVie Inc, Irvine, California.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Robinson', 'Affiliation': 'AbbVie Inc, Irvine, California.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2022.0059']
3092,35238894,"Efficacy and Safety of K-877 (Pemafibrate), a Selective PPARα Modulator, in European Patients on Statin Therapy.","OBJECTIVE


High plasma triglyceride (TG) is an independent risk factor for cardiovascular disease. Fibrates lower TG levels through peroxisome proliferator-activated receptor α (PPARα) agonism. Currently available fibrates, however, have relatively low selectivity for PPARα. The aim of this trial was to assess the safety, tolerability, and efficacy of K-877 (pemafibrate), a selective PPARα modulator, in statin-treated European patients with hypertriglyceridemia.
RESEARCH DESIGN AND METHODS


A total of 408 statin-treated adults were recruited from 68 European sites for this phase 2, randomized, double-blind, placebo-controlled trial. They had fasting TG between 175 and 500 mg/dL and HDL-cholesterol (HDL-C) ≤50 mg/dL for men and ≤55 mg/dL for women. Participants were randomly assigned to receive placebo or one of six pemafibrate regimens: 0.05 mg twice a day, 0.1 mg twice a day, 0.2 mg twice a day, 0.1 mg once daily, 0.2 mg once daily, or 0.4 mg once daily. The primary end points were TG and non-HDL-C level lowering at week 12.
RESULTS


Pemafibrate reduced TG at all doses (adjusted P value <0.001), with the greatest placebo-corrected reduction from baseline to week 12 observed in the 0.2-mg twice a day treatment group (54.4%). Reductions in non-HDL-C did not reach statistical significance. Reductions in TG were associated with improvements in other markers for TG-rich lipoprotein metabolism, including reductions in apoB48, apoCIII, and remnant cholesterol and an increase in HDL-C levels. Pemafibrate increased LDL-cholesterol levels, whereas apoB100 was unchanged. Pemafibrate was safe and well-tolerated, with only minor increases in serum creatinine and homocysteine concentrations.
CONCLUSION


Pemafibrate is effective, safe, and well-tolerated for the reduction of TG in European populations with hypertriglyceridemia despite statin treatment.",2022,"RESULTS


Pemafibrate reduced TG at all doses (adjusted P value <0.001), with the greatest placebo-corrected reduction from baseline to week 12 observed in the 0.2-mg twice a day treatment group (54.4%).","['European Patients on Statin Therapy', 'A total of 408 statin-treated adults were recruited from 68 European sites for this phase 2', 'European populations with hypertriglyceridemia despite statin treatment', 'statin-treated European patients with hypertriglyceridemia']","['placebo', 'K-877 (Pemafibrate', 'K-877 (pemafibrate']","['apoB48, apoCIII, and remnant cholesterol and an increase in HDL-C levels', 'TG and non-HDL-C level lowering', 'serum creatinine and homocysteine concentrations', 'LDL-cholesterol levels', 'safety, tolerability, and efficacy', 'safe and well-tolerated']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0103839', 'cui_str': 'Apolipoprotein B-48'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.215567,"RESULTS


Pemafibrate reduced TG at all doses (adjusted P value <0.001), with the greatest placebo-corrected reduction from baseline to week 12 observed in the 0.2-mg twice a day treatment group (54.4%).","[{'ForeName': 'Henry N', 'Initials': 'HN', 'LastName': 'Ginsberg', 'Affiliation': 'Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Hounslow', 'Affiliation': 'Kowa Research Europe, Ltd., Berkshire, United Kingdom.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Senko', 'Affiliation': 'Kowa Company, Ltd., Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Suganami', 'Affiliation': 'Kowa Company, Ltd., Tokyo, Japan.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Bogdanski', 'Affiliation': 'Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences, Poland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ceska', 'Affiliation': 'Department of Internal Medicine, Charles University and University General Hospital, Prague, Czech Republic.'}, {'ForeName': 'Akos', 'Initials': 'A', 'LastName': 'Kalina', 'Affiliation': 'Hungarian Defense Forces Medical Centre, Budapest, Hungary.'}, {'ForeName': 'Roman A', 'Initials': 'RA', 'LastName': 'Libis', 'Affiliation': 'Orenburg State Medical University, Orenburg, Russia.'}, {'ForeName': 'Tatiana V', 'Initials': 'TV', 'LastName': 'Supryadkina', 'Affiliation': 'First City Clinical Hospital named after E.E. osevitch, Arkhangelsk, Russia.'}, {'ForeName': 'G Kees', 'Initials': 'GK', 'LastName': 'Hovingh', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, Amsterdam, the Netherlands.'}]",Diabetes care,['10.2337/dc21-1288']
3093,35238796,Blood flow restriction maintains blood pressure upon head-up tilt.,"Background


Orthostatic intolerance occurs in some astronauts following space flight. Although orthostatic blood pressure responses should normalize in the weeks following the return to Earth, there may be situations where an immediate short-term solution is necessary (e.g., emergency evacuation).
Purpose


The purpose of this study was to examine different levels of blood flow restriction on changes in blood pressure and heart rate when transitioning from supine to a head-up tilt and determine whether this change differs based on sex.
Methods


Eighty-nine participants (45 men, 44 women) completed the three visits with different pressures (Sham, Moderate, and High) in a randomized order. Cuffs were placed on the most proximal area of the thighs. Brachial blood pressure was measured at baseline, upon inflation of the cuffs in a supine position, immediately after tilt (70°), and eight more times separated by 45 seconds.
Results


Data are presented as mean (SD). The change in systolic (High > Moderate > Sham) [High vs Sham: 5.5 (7.4) mmHg, High vs Moderate: 3 (7.4) mmHg, and Moderate vs Sham: 2.4 (8.4) mmHg] and diastolic pressure (High > Moderate = Sham) [High vs Sham: 2.4 (5.3) mmHg, High vs Moderate: 1.9 (6.3) mmHg] differed across applied pressures. The change in heart rate was initially greatest in the sham-pressure but increased the greatest in the high-pressure condition by the end of the head-up tilt period. Additionally, there was no influence of sex.
Conclusion


Blood flow restriction applied in this study increased blood pressure in a pressure-dependent manner upon head-up tilt.",2022,The change in heart rate was initially greatest in the sham-pressure but increased the greatest in the high-pressure condition by the end of the head-up tilt period.,"['Methods\n\n\nEighty-nine participants (45 men, 44 women']",[],"['orthostatic blood pressure responses', 'heart rate', 'blood pressure', 'Brachial blood pressure', 'Blood flow restriction maintains blood pressure', 'blood pressure and heart rate', 'diastolic pressure']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",89.0,0.0844747,The change in heart rate was initially greatest in the sham-pressure but increased the greatest in the high-pressure condition by the end of the head-up tilt period.,"[{'ForeName': 'Vickie', 'Initials': 'V', 'LastName': 'Wong', 'Affiliation': '1 Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Bell', 'Affiliation': '1 Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Sptiz', 'Affiliation': '1 Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Jun Seob', 'Initials': 'JS', 'LastName': 'Song', 'Affiliation': '1 Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Yujiro', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': '1 Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': '2 Institute of Health and Sports Science and Medicine, Juntendo University, Inzai, Chiba 270-1695, Japan.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Loenneke', 'Affiliation': '1 Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}]",Physiology international,['10.1556/2060.2022.00051']
3094,35238794,Feasibility and Preliminary Efficacy of Web-Based and Mobile Interventions for Common Mental Health Problems in Working Adults: Multi-Arm Randomized Pilot Trial.,"BACKGROUND


There is growing interest in digital platforms as a means of implementing scalable, accessible, and cost-effective mental health interventions in the workplace. However, little is known about the efficacy of such interventions when delivered to employee groups.
OBJECTIVE


This study aims to evaluate the feasibility and preliminary efficacy of a digital mental health platform for the workplace, which incorporates evidence-based practices such as cognitive behavioral therapy and acceptance and commitment therapy. A total of 3 brief, unguided interventions designed to address stress, anxiety, and resilience, respectively, are evaluated. The primary aim is to determine the feasibility of the study methods and interventions in preparation for a definitive randomized controlled trial.
METHODS


The study used a fully remote, parallel, multi-arm, external pilot randomized controlled trial, with 3 intervention arms and a no-intervention control group. Participants were working adults representative of the general UK population with respect to age, sex, and ethnicity who were recruited from a web-based participant platform. Primary outcomes included objective and self-report measures of feasibility, acceptability, engagement, transferability, relevance, and negative effects. Secondary outcomes included 4 self-report measures of mental health and well-being, completed at baseline (time point 0 [t0]), postintervention (time point 1 [t1]), and the 1-month follow-up (time point 2 [t2]). Secondary outcomes were analyzed via linear mixed-effects models using intention-to-treat principles. Preregistered criteria for progression to a definitive trial were evaluated.
RESULTS


Data were collected between January and March of 2021. A total of 383 working adult participants meeting trial eligibility were randomized, of whom 356 (93%) were retained at t2. Objective engagement data showed that 67.8% (196/289) of participants randomized to an intervention arm completed their intervention. Overall, 87.1% (203/233) of participants reported being satisfied or very satisfied with their intervention and rated the quality of their intervention as good or excellent. All intervention groups reported significantly greater improvements than the control group on at least one secondary outcome at t1, with between-group Hedges g effect sizes for the pooled interventions ranging from 0.25 (95% CI 0.05-0.46) to 0.43 (95% CI 0.23-0.64). All the improvements were maintained at t2.
CONCLUSIONS


The study methods were feasible, and all preregistered criteria for progression to a definitive trial were met. Several minor protocol amendments were noted. Preliminary efficacy findings suggest that the study interventions may result in improved mental health outcomes when offered to working adults.
TRIAL REGISTRATION


ISRCTN Registry 80309011; http://www.isrctn.com/ISRCTN80309011.",2022,"All intervention groups reported significantly greater improvements than the control group on at least one secondary outcome at t1, with between-group Hedges g effect sizes for the pooled interventions ranging from 0.25 (95% CI 0.05-0.46) to 0.43","['383 working adult participants meeting trial eligibility', 'Common Mental Health Problems in Working Adults', 'Participants were working adults representative of the general UK population with respect to age, sex, and ethnicity who were recruited from a web-based participant platform']","['digital mental health platform', 'Web-Based and Mobile Interventions']","['objective and self-report measures of feasibility, acceptability, engagement, transferability, relevance, and negative effects', '4 self-report measures of mental health and well-being, completed at baseline (time point 0', 'mental health outcomes']","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",383.0,0.256917,"All intervention groups reported significantly greater improvements than the control group on at least one secondary outcome at t1, with between-group Hedges g effect sizes for the pooled interventions ranging from 0.25 (95% CI 0.05-0.46) to 0.43","[{'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Economides', 'Affiliation': 'Unmind Ltd, London, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Bolton', 'Affiliation': 'Unmind Ltd, London, United Kingdom.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Male', 'Affiliation': 'Unmind Ltd, London, United Kingdom.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Cavanagh', 'Affiliation': 'School of Psychology, University of Sussex, East Sussex, United Kingdom.'}]",JMIR formative research,['10.2196/34032']
3095,35238793,Rehabilitation Using Mobile Health for Older Adults With Ischemic Heart Disease in the Home Setting (RESILIENT): Protocol for a Randomized Controlled Trial.,"BACKGROUND


Participation in ambulatory cardiac rehabilitation remains low, especially among older adults. Although mobile health cardiac rehabilitation (mHealth-CR) provides a novel opportunity to deliver care, age-specific impairments may limit older adults' uptake, and efficacy data are currently lacking.
OBJECTIVE


This study aims to describe the design of the rehabilitation using mobile health for older adults with ischemic heart disease in the home setting (RESILIENT) trial.
METHODS


RESILIENT is a multicenter randomized clinical trial that is enrolling patients aged ≥65 years with ischemic heart disease in a 3:1 ratio to either an intervention (mHealth-CR) or control (usual care) arm, with a target sample size of 400 participants. mHealth-CR consists of a commercially available mobile health software platform coupled with weekly exercise therapist sessions to review progress and set new activity goals. The primary outcome is a change in functional mobility (6-minute walk distance), which is measured at baseline and 3 months. Secondary outcomes are health status, goal attainment, hospital readmission, and mortality. Among intervention participants, engagement with the mHealth-CR platform will be analyzed to understand the characteristics that determine different patterns of use (eg, persistent high engagement and declining engagement).
RESULTS


As of December 2021, the RESILIENT trial had enrolled 116 participants. Enrollment is projected to continue until October 2023. The trial results are expected to be reported in 2024.
CONCLUSIONS


The RESILIENT trial will generate important evidence about the efficacy of mHealth-CR among older adults in multiple domains and characteristics that determine the sustained use of mHealth-CR. These findings will help design future precision medicine approaches to mobile health implementation in older adults. This knowledge is especially important in light of the COVID-19 pandemic that has shifted much of health care to a remote, internet-based setting.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03978130; https://clinicaltrials.gov/ct2/show/NCT03978130.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/32163.",2022,mHealth-CR consists of a commercially available mobile health software platform coupled with weekly exercise therapist sessions to review progress and set new activity goals.,"['trial had enrolled 116 participants', 'older adults with ischemic heart disease in the home setting (RESILIENT) trial', 'Older Adults With Ischemic Heart Disease', 'enrolling patients aged ≥65 years with ischemic heart disease in a 3:1 ratio to either an intervention (mHealth-CR) or control (usual care) arm, with a target sample size of 400 participants', 'older adults']","['Rehabilitation Using Mobile Health', 'mobile health cardiac rehabilitation (mHealth-CR']","['change in functional mobility (6-minute walk distance', 'health status, goal attainment, hospital readmission, and mortality']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",116.0,0.295336,mHealth-CR consists of a commercially available mobile health software platform coupled with weekly exercise therapist sessions to review progress and set new activity goals.,"[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Dodson', 'Affiliation': 'Geriatric Cardiology Program, Medicine and Population Health, Leon H Charney Division of Cardiology, NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Schoenthaler', 'Affiliation': 'Department of Population Health, Department of Medicine, NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Sweeney', 'Affiliation': 'Department of Rehabilitation Medicine, NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fonceva', 'Affiliation': 'Leon H Charney Division of Cardiology, NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Pierre', 'Affiliation': 'Department of Rehabilitation Medicine, NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Whiteson', 'Affiliation': 'Department of Rehabilitation Medicine, Department of Medicine, NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'George', 'Affiliation': 'Division of Cardiology, Department of Medicine, NYU Long Island School of Medicine, Mineola, NY, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Marzo', 'Affiliation': 'Department of Medicine, Division of Cardiology, NYU Long Island School of Medicine, Mineola, NY, United States.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Drewes', 'Affiliation': 'Division of Cardiology, NYU Langone Hospital Long Island, Mineola, NY, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rerisi', 'Affiliation': 'Division of Cardiology, NYU Langone Hospital Long Island, Mineola, NY, United States.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Mathew', 'Affiliation': 'Division of Cardiology, NYU Langone Hospital Long Island, Mineola, NY, United States.'}, {'ForeName': 'Haneen', 'Initials': 'H', 'LastName': 'Aljayyousi', 'Affiliation': 'Leon H Charney Division of Cardiology, NYU Grossman School of Medicine, New York, NY, United States.'}, {'ForeName': 'Sarwat I', 'Initials': 'SI', 'LastName': 'Chaudhry', 'Affiliation': 'Section of General Medicine, Yale University School of Medicine, New Haven, NY, United States.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Hajduk', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, United States.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Estrin', 'Affiliation': 'Cornell Tech and Weill Cornell Medicine, New York, NY, United States.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Kovell', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School, UMass Memorial Medical Center, Worcester, MA, United States.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Jennings', 'Affiliation': 'Reynolds Section of Geriatric Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}, {'ForeName': 'Samrachana', 'Initials': 'S', 'LastName': 'Adhikari', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, NY, United States.'}]",JMIR research protocols,['10.2196/32163']
3096,35238791,Using Momentary Assessment and Machine Learning to Identify Barriers to Self-management in Type 1 Diabetes: Observational Study.,"BACKGROUND


For adolescents living with type 1 diabetes (T1D), completion of multiple daily self-management tasks, such as monitoring blood glucose and administering insulin, can be challenging because of psychosocial and contextual barriers. These barriers are hard to assess accurately and specifically by using traditional retrospective recall. Ecological momentary assessment (EMA) uses mobile technologies to assess the contexts, subjective experiences, and psychosocial processes that surround self-management decision-making in daily life. However, the rich data generated via EMA have not been frequently examined in T1D or integrated with machine learning analytic approaches.
OBJECTIVE


The goal of this study is to develop a machine learning algorithm to predict the risk of missed self-management in young adults with T1D. To achieve this goal, we train and compare a number of machine learning models through a learned filtering architecture to explore the extent to which EMA data were associated with the completion of two self-management behaviors: mealtime self-monitoring of blood glucose (SMBG) and insulin administration.
METHODS


We analyzed data from a randomized controlled pilot study using machine learning-based filtering architecture to investigate whether novel information related to contextual, psychosocial, and time-related factors (ie, time of day) relate to self-management. We combined EMA-collected contextual and insulin variables via the MyDay mobile app with Bluetooth blood glucose data to construct machine learning classifiers that predicted the 2 self-management behaviors of interest.
RESULTS


With 1231 day-level SMBG frequency counts for 45 participants, demographic variables and time-related variables were able to predict whether daily SMBG was below the clinical threshold of 4 times a day. Using the 1869 data points derived from app-based EMA data of 31 participants, our learned filtering architecture method was able to infer nonadherence events with high accuracy and precision. Although the recall score is low, there is high confidence that the nonadherence events identified by the model are truly nonadherent.
CONCLUSIONS


Combining EMA data with machine learning methods showed promise in the relationship with risk for nonadherence. The next steps include collecting larger data sets that would more effectively power a classifier that can be deployed to infer individual behavior. Improvements in individual self-management insights, behavioral risk predictions, enhanced clinical decision-making, and just-in-time patient support in diabetes could result from this type of approach.",2022,"Although the recall score is low, there is high confidence that the nonadherence events identified by the model are truly nonadherent.
","['Type 1 Diabetes', 'adolescents living with type 1 diabetes (T1D', 'young adults with T1D']","['Ecological momentary assessment (EMA', 'machine learning-based filtering architecture', 'Momentary Assessment and Machine Learning', 'machine learning algorithm']",[],"[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",[],,0.03451,"Although the recall score is low, there is high confidence that the nonadherence events identified by the model are truly nonadherent.
","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Computer Science, School of Engineering, Vanderbilt University, Nashville, TN, United States.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Fonnesbeck', 'Affiliation': 'Department of Biostatistics, Vanderbilt University, Nashville, TN, United States.'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Schmidt', 'Affiliation': 'Department of Computer Science, School of Engineering, Vanderbilt University, Nashville, TN, United States.'}, {'ForeName': 'Jules', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Department of Computer Science, School of Engineering, Vanderbilt University, Nashville, TN, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Kleinberg', 'Affiliation': 'Department of Computer Science, Stevens Institute of Technology, Hoboken, NJ, United States.'}, {'ForeName': 'Shelagh A', 'Initials': 'SA', 'LastName': 'Mulvaney', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, United States.'}]",JMIR mHealth and uHealth,['10.2196/21959']
3097,35239009,Macular neovascularization lesion type and vision outcomes in neovascular age-related macular degeneration: post hoc analysis of HARBOR.,"PURPOSE


To characterize relationships between Consensus on Neovascular Age-Related Macular Degeneration Nomenclature (CONAN) Study Group classifications of macular neovascularization (MNV) and visual responses to ranibizumab in patients with neovascular age-related macular degeneration (nAMD).
METHODS


This was a post hoc analysis of the phase 3 HARBOR trial of ranibizumab in nAMD. Analyses included ranibizumab-treated eyes with baseline multimodal imaging data; baseline MNV; subretinal and/or intraretinal fluid at screening, baseline, or week 1; and spectral-domain optical coherence tomography images through month 24 (n = 700). Mean best-corrected visual acuity (BCVA) over time and mean BCVA change at months 12 and 24 were compared between eyes with type 1, type 2/mixed type 1 and 2 (type 2/M), and any type 3 MNV at baseline.
RESULTS


At baseline, 263 (37.6%), 287 (41.0%), and 150 (21.4%) eyes had type 1, type 2/M, and any type 3 lesions, respectively. Type 1 eyes had the best mean BCVA at baseline (59.0 [95% CI: 57.7-60.3] letters) and month 24 (67.7 [65.8-69.6] letters), whereas type 2/M eyes had the worst (50.0 [48.6-51.4] letters and 60.8 [58.7-62.9] letters, respectively). Mean BCVA gains at month 24 were most pronounced for type 2/M eyes (10.8 [8.9-12.7] letters) and similar for type 1 (8.7 [6.9-10.5] letters) and any type 3 eyes (8.3 [6.3-10.3] letters).
CONCLUSION


Differences in BCVA outcomes between CONAN lesion type subgroups support the use of an anatomic classification system to characterize MNV and prognosticate visual responses to anti-vascular endothelial growth factor therapy for nAMD.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00891735. Date of registration: April 29, 2009.",2022,"Type 1 eyes had the best mean BCVA at baseline (59.0 [95% CI: 57.7-60.3] letters) and month 24 (67.7 [65.8-69.6] letters), whereas type 2/M eyes had the worst (50.0 [48.6-51.4] letters and 60.8 [58.7-62.9] letters, respectively).","['patients with neovascular age-related macular degeneration (nAMD', 'neovascular age-related macular degeneration']",['ranibizumab'],"['Macular neovascularization lesion type and vision outcomes', 'Mean best-corrected visual acuity (BCVA) over time and mean BCVA change', 'Mean BCVA gains', 'mean BCVA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C4324512', 'cui_str': 'Macular neovascularisation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.232272,"Type 1 eyes had the best mean BCVA at baseline (59.0 [95% CI: 57.7-60.3] letters) and month 24 (67.7 [65.8-69.6] letters), whereas type 2/M eyes had the worst (50.0 [48.6-51.4] letters and 60.8 [58.7-62.9] letters, respectively).","[{'ForeName': 'K Bailey', 'Initials': 'KB', 'LastName': 'Freund', 'Affiliation': 'Vitreous Retina Macula Consultants of New York, New York, NY, USA. kbfreund@gmail.com.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Staurenghi', 'Affiliation': 'Department of Biomedical and Clinical Science Luigi Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy.'}, {'ForeName': 'Jesse J', 'Initials': 'JJ', 'LastName': 'Jung', 'Affiliation': 'East Bay Retina Consultants, Inc., Oakland, CA, USA.'}, {'ForeName': 'Sandrine A', 'Initials': 'SA', 'LastName': 'Zweifel', 'Affiliation': 'Department of Ophthalmology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Cozzi', 'Affiliation': 'Department of Biomedical and Clinical Science Luigi Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hill', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Blotner', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tsuboi', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Shamika', 'Initials': 'S', 'LastName': 'Gune', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-022-05586-w']
3098,35238960,Clinical comparative study assessing the effect of ivabradine on neopterin and NT-Pro BNP against standard treatment in chronic heart failure patients.,"PURPOSE


Heart rate reduction (HR) is a cornerstone in heart failure therapy as it improves patient outcomes. The aim of this study is to evaluate short-term effect of ivabradine on NT-Pro BNP and neopterin in heart failure patients and assess the association between HR and these biomarkers.
METHODS


Sixty patients on standard heart failure therapy were randomly allocated into ivabradine group (n = 30) and non-ivabradine group (n = 30). Ivabradine 5 mg twice daily was given for 3 months. Lipid profile and kidney functions were performed and blood samples for NT-Pro BNP and neopterin were analysed at baseline and after 3 months of intervention in both groups.
RESULTS


There was a significant improvement in NYHA class in ivabradine group (p < 0.001). Ejection fraction was improved in ivabradine and non-ivabradine groups after intervention (p < 0.001), with a greater improvement in ivabradine group (p = 0.026). Heart rate was reduced in ivabradine group (p < 0.001) and non-ivabradine group (p < 0.001) yet greater reduction was seen in ivabradine group (p < 0.001). Serum creatinine and blood urea nitrogen were reduced in ivabradine group (Scr: p = 0.001, BUN: p = 0.001). NT-Pro BNP and neopterin levels significantly decreased in ivabradine group (NT-Pro BNP: p < 0.001, neopterin p < 0.001). Significant positive correlation was found between HR and biomarker levels after intervention (NT-Pro BNP: r = 0.475, p < 0.001, neopterin: r = 0.384, p = 0.002).
CONCLUSION


Ivabradine therapy reduced levels of both biomarkers which correlated well with HR. Biomarker levels might provide a tool for assessing ivabradine effectiveness in HF. Trial registration Date: June 26, 2020. Identifier: NCT04448899. Link: Ivabradine in Patients with Congestive Heart Failure-Full Text View-ClinicalTrials.gov.",2022,"Serum creatinine and blood urea nitrogen were reduced in ivabradine group (Scr: p = 0.001, BUN: p = 0.001).","['heart failure patients', 'Sixty patients on standard heart failure therapy', 'chronic heart failure patients', 'Patients with Congestive Heart Failure-Full Text View-ClinicalTrials.gov']","['ivabradine group (n\u2009=\u200930) and non-ivabradine', 'Ivabradine therapy', 'NT-Pro BNP against standard treatment', 'ivabradine group (NT-Pro BNP', 'ivabradine', 'Ivabradine']","['NT-Pro BNP and neopterin levels', 'blood samples for NT-Pro BNP and neopterin', 'HR and biomarker levels', 'Heart rate', 'Lipid profile and kidney functions', 'Ejection fraction', 'Serum creatinine and blood urea nitrogen', 'NT-Pro BNP and neopterin', 'NYHA class']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0449911', 'cui_str': 'View'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",,0.0421423,"Serum creatinine and blood urea nitrogen were reduced in ivabradine group (Scr: p = 0.001, BUN: p = 0.001).","[{'ForeName': 'Gaidaa M', 'Initials': 'GM', 'LastName': 'Dogheim', 'Affiliation': 'Pharmacy Practice Department, Faculty of Pharmacy, Alexandria University, Al Mesallah Sharq, Qism Bab Sharqi, Alexandria, Alexandria Governorate, Egypt. jayda.maher@alexu.edu.eg.'}, {'ForeName': 'Ibtsam', 'Initials': 'I', 'LastName': 'Khairat', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Gamal A', 'Initials': 'GA', 'LastName': 'Omran', 'Affiliation': 'Biochemistry Department, Faculty of Pharmacy, Damanhour University, Damanhour, 22514, Egypt.'}, {'ForeName': 'Sahar M', 'Initials': 'SM', 'LastName': 'El-Haggar', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ahmed M El', 'Initials': 'AME', 'LastName': 'Amrawy', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Rehab H', 'Initials': 'RH', 'LastName': 'Werida', 'Affiliation': 'Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, Damanhour University, Damanhour, 22514, Egypt.'}]",European journal of clinical pharmacology,['10.1007/s00228-022-03290-6']
3099,35238954,Instant improvement in monaural spatial hearing abilities through cognitive feedback.,"Several studies report that sound localization performance of acute and chronic monauralized normal-hearing listeners can improve through training. Typically, training sessions are administered daily for several days or weeks. While this intensive training is effective, it may also be that monaural localization abilities improve instantly after providing explicit top-down information about the direction dependent change in timbre and level. The aim of the present study was to investigate whether cognitive feedback (i.e., top-down information) could instantly improve sound localization in naive acutely monauralized listeners. Forty-three normal-hearing listeners (experimental group), divided over five different centers, were tested. Two control groups, consisting of, respectively, nine and eleven normal-hearing listeners, were tested in one center. Broadband sounds (0.5-20 kHz) were presented from visible loudspeakers, positioned in azimuth (- 90° to 90°). Participants in the experimental group received explicit information about the noticeable difference in timbre and the poor localization in the monauralized listening condition, resulting in an instant improvement in sound localization abilities. With subsequent roving of stimulus level (20 dB), sound localization performance deteriorated immediately. The reported improvement is related to the context of the localization test. The results provide important implications for studies investigating sound localization in a clinical setting, especially during closed-set testing, and indicate the importance of top-down information.",2022,Several studies report that sound localization performance of acute and chronic monauralized normal-hearing listeners can improve through training.,"['acute and chronic monauralized normal-hearing listeners', 'naive acutely monauralized listeners', 'Forty-three normal-hearing listeners (experimental group), divided over five different centers, were tested']",[],"['cognitive feedback', 'monaural spatial hearing abilities through cognitive feedback']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0234725', 'cui_str': 'Hearing normal'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",[],"[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0284451,Several studies report that sound localization performance of acute and chronic monauralized normal-hearing listeners can improve through training.,"[{'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Arras', 'Affiliation': 'Department of Neurosciences, Experimental ORL, KU Leuven, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Snapp', 'Affiliation': 'Department of Otolaryngology, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Sangen', 'Affiliation': 'Department of Neurosciences, Experimental ORL, KU Leuven, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Snels', 'Affiliation': 'Department of Otorhinolaryngology, Donders Institute for Brain, Cognition and Behaviour, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Kuntz', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Tinne', 'Initials': 'T', 'LastName': 'Theunen', 'Affiliation': 'ENT Department Sint-Augustinus Antwerp, European Institute For ORL, Antwerp, Belgium.'}, {'ForeName': 'Kiana', 'Initials': 'K', 'LastName': 'Kheirkhah', 'Affiliation': 'Department of Biophysics, Donders Institute for Brain, Cognition and Behaviour, Radboud University, Heyendaalseweg 135, 6525 AJ, Nijmegen, The Netherlands.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Zarowski', 'Affiliation': 'ENT Department Sint-Augustinus Antwerp, European Institute For ORL, Antwerp, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wesarg', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'van Wieringen', 'Affiliation': 'Department of Neurosciences, Experimental ORL, KU Leuven, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Martijn J H', 'Initials': 'MJH', 'LastName': 'Agterberg', 'Affiliation': 'Department of Otorhinolaryngology, Donders Institute for Brain, Cognition and Behaviour, Radboudumc, Nijmegen, The Netherlands. m.agterberg@donders.ru.nl.'}]",Experimental brain research,['10.1007/s00221-022-06333-7']
3100,35239245,Vericiguat in Patients with Coronary Artery Disease and Heart Failure with Reduced Ejection Fraction.,"AIMS


Coronary artery disease (CAD) portends worse outcomes in heart failure (HF). We aimed to characterize patients with CAD and worsening HF with reduced ejection fraction (HFrEF) and evaluate post hoc whether vericiguat's treatment effect varied according to CAD.
METHODS AND RESULTS


Cox proportional hazards were generated for the primary endpoint of cardiovascular death or HF hospitalization (CVD/HFH). CAD was defined as previous myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting. Of 5048 patients in VICTORIA with available data on CAD status, 2704 had CAD and were older, were more frequently male, diabetic, and had a lower glomerular filtration rate than those without CAD (all p <0.0001). Use of implantable cardioverter defibrillators and cardiac resynchronization therapy (CRT) was higher in patients with versus without CAD (33.5 vs. 21.1%; p <0.0001 and 16.3 vs. 12.8%; p = 0.0006). The primary endpoint of CVD/HFH was higher in those with versus without CAD (40.6 vs. 30.1/100 patient-years; adjusted hazard ratio [HR] 1.23; p <0.001) as was all-cause mortality (17.9% vs. 12.7%; adjusted HR 1.32; p <0.001). The primary outcome of CVD/HFH associated with vericiguat in patients with or without CAD was 38.8 vs. 27.6 per 100 patient-years and for placebo was 42.6 vs. 32.7 per 100 patient-years (interaction p = 0.78).
CONCLUSION


In this post hoc study, CAD was associated with more CVD and HFH in patients with HFrEF and worsening HF. Vericiguat was beneficial and safe regardless of concomitant CAD. This article is protected by copyright. All rights reserved.",2022,p <0.001) as was all-cause mortality (17.9% vs. 12.7%; adjusted HR 1.32; p <0.001).,"['Patients with Coronary Artery Disease and Heart Failure with Reduced Ejection Fraction', '5048 patients in VICTORIA with available data on CAD status, 2704 had CAD and were older', 'patients with HFrEF and worsening HF', 'patients with CAD and worsening HF with reduced ejection fraction (HFrEF', 'heart failure (HF']","['implantable cardioverter defibrillators and cardiac resynchronization therapy (CRT', 'coronary artery bypass grafting', 'placebo']","['cause mortality', 'glomerular filtration rate', 'CVD/HFH associated with vericiguat in patients with or without CAD', 'CVD/HFH', 'cardiovascular death or HF hospitalization (CVD/HFH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",,0.130884,p <0.001) as was all-cause mortality (17.9% vs. 12.7%; adjusted HR 1.32; p <0.001).,"[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Saldarriaga', 'Affiliation': 'University of Antioquia, CardioVID clinic Department of Cardiology, Medellín, Colombia.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Atar', 'Affiliation': 'Oslo University Hospital Ulleval, Department of Cardiology, and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Stebbins', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, United States.'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'Lady Davis Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Zainal Abidin', 'Affiliation': 'UM Specialist Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Blaustein', 'Affiliation': 'Merck & Co. Inc., Kenilworth, New Jersey, United States.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'University of Mississippi Medical Center, Jackson, Mississippi, United States.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, United States.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore & Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia, United States.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Charité University Medicine, German Heart Center, Berlin, Germany.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, United States.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.2468']
3101,34737296,Restoration of HBV-specific CD8 +  T-cell responses by sequential low-dose IL-2 treatment in non-responder patients after IFN-α therapy.,"Patients with chronic hepatitis B (CHB) undergoing interferon (IFN)-α-based therapies often exhibit a poor HBeAg serological response. Thus, there is an unmet need for new therapies aimed at CHB. This study comprised two clinical trials, including 130 CHB patients, who were treatment-naïve; in the first, 92 patients were systematically analyzed ex vivo for interleukin-2 receptor (IL-2R) expression and inhibitory molecules expression after receiving Peg-IFN-α-2b therapy. In our second clinical trial, 38 non-responder patients, in whom IFN-α therapy had failed, were treated with or without low-dose IL-2 for 24 weeks. We then examined the hepatitis B virus (HBV)-specific CD8 +  T-cell response and the clinical outcome, in these patients. Although the majority of the participants undergoing Peg-IFN-α-2b therapy were non-responders, we observed a decrease in CD25 expression on their CD4 +  T cells, suggesting that IFN-α therapy may provide a rationale for sequential IL-2 treatment without increasing regulatory T cells (Tregs). Following sequential therapy with IL-2, we demonstrated that the non-responders experienced a decrease in the numbers of Tregs and programmed cell death protein 1 (PD-1) expression. In addition, sequential IL-2 administration rescued effective immune function, involving signal transducer and activator of transcription 1 (STAT1) activation. Importantly, IL-2 therapy significantly increased the frequency and function of HBV-specific CD8 +  T cells, which translated into improved clinical outcomes, including HBeAg seroconversion, among the non-responder CHB patients. Our findings suggest that sequential IL-2 therapy shows efficacy in rescuing immune function in non-responder patients with refractory CHB.",2021,"Importantly, IL-2 therapy significantly increased the frequency and function of HBV-specific CD8 +  T cells, which translated into improved clinical outcomes, including HBeAg seroconversion, among the non-responder CHB patients.","['non-responder patients with refractory CHB', 'non-responder patients after IFN-α therapy', 'Patients with chronic hepatitis B (CHB) undergoing', '130 CHB patients, who were treatment-naïve; in the first, 92 patients were systematically analyzed ex vivo for interleukin-2 receptor (IL-2R) expression and inhibitory molecules expression after receiving Peg-IFN-α-2b therapy']","['IFN-α therapy', 'sequential IL-2 therapy', 'interferon (IFN)-α-based therapies']","['hepatitis B virus (HBV)-specific CD8 +  T-cell response', 'frequency and function of HBV-specific CD8 +  T cells', 'effective immune function, involving signal transducer and activator of transcription 1 (STAT1) activation', 'CD25 expression', 'Restoration of HBV-specific CD8 +  T-cell responses', 'numbers of Tregs and programmed cell death protein 1 (PD-1) expression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034819', 'cui_str': 'Interleukin-2 receptor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199975', 'cui_str': 'Interleukin-2 therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0287920', 'cui_str': 'STAT1 Protein'}, {'cui': 'C0007507', 'cui_str': 'Lymphocyte antigen CD25'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0135710', 'cui_str': 'PDCD1 protein, human'}]",38.0,0.0920045,"Importantly, IL-2 therapy significantly increased the frequency and function of HBV-specific CD8 +  T cells, which translated into improved clinical outcomes, including HBeAg seroconversion, among the non-responder CHB patients.","[{'ForeName': 'Dongyao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Institute of Immunology and the CAS Key Laboratory of Innate Immunity and Chronic Disease, School of Basic Medicine and Medical Center, University of Science and Technology of China, Hefei, Anhui, 230001, China.'}, {'ForeName': 'Binqing', 'Initials': 'B', 'LastName': 'Fu', 'Affiliation': 'Institute of Immunology and the CAS Key Laboratory of Innate Immunity and Chronic Disease, School of Basic Medicine and Medical Center, University of Science and Technology of China, Hefei, Anhui, 230001, China.'}, {'ForeName': 'Xiaokun', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Institute of Immunology and the CAS Key Laboratory of Innate Immunity and Chronic Disease, School of Basic Medicine and Medical Center, University of Science and Technology of China, Hefei, Anhui, 230001, China.'}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Institute of Immunology and the CAS Key Laboratory of Innate Immunity and Chronic Disease, School of Basic Medicine and Medical Center, University of Science and Technology of China, Hefei, Anhui, 230001, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Infectious Diseases, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230027, China.'}, {'ForeName': 'Junfei', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230027, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Institute of Immunology and the CAS Key Laboratory of Innate Immunity and Chronic Disease, School of Basic Medicine and Medical Center, University of Science and Technology of China, Hefei, Anhui, 230001, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Department of Infectious Diseases, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230027, China.'}, {'ForeName': 'Jiabin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Diseases, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230027, China. lijiabin@ahmu.edu.cn.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Tian', 'Affiliation': 'Institute of Immunology and the CAS Key Laboratory of Innate Immunity and Chronic Disease, School of Basic Medicine and Medical Center, University of Science and Technology of China, Hefei, Anhui, 230001, China. tzg@ustc.edu.cn.'}, {'ForeName': 'Haiming', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Institute of Immunology and the CAS Key Laboratory of Innate Immunity and Chronic Disease, School of Basic Medicine and Medical Center, University of Science and Technology of China, Hefei, Anhui, 230001, China. ustcwhm@ustc.edu.cn.'}]",Signal transduction and targeted therapy,['10.1038/s41392-021-00776-0']
3102,34755130,High-resolution epitope mapping by AllerScan reveals relationships between IgE and IgG repertoires during peanut oral immunotherapy.,"Peanut allergy can result in life-threatening reactions and is a major public health concern. Oral immunotherapy (OIT) induces desensitization to food allergens through administration of increasing amounts of allergen. To dissect peanut-specific immunoglobulin E (IgE) and IgG responses in subjects undergoing OIT, we have developed AllerScan, a method that leverages phage-display and next-generation sequencing to identify the epitope targets of peanut-specific antibodies. We observe a striking diversification and boosting of the peanut-specific IgG repertoire after OIT and a reduction in pre-existing IgE levels against individual epitopes. High-resolution epitope mapping reveals shared recognition of public epitopes in Ara h 1, 2, 3, and 7. In individual subjects, OIT-induced IgG specificities overlap extensively with IgE and exhibit strikingly similar antibody footprints, suggesting related clonal lineages or convergent evolution of peanut-specific IgE and IgG B cells. Individual differences in epitope recognition identified via AllerScan could inform safer and more effective personalized immunotherapy.",2021,We observe a striking diversification and boosting of the peanut-specific IgG repertoire after OIT and a reduction in pre-existing IgE levels against individual epitopes.,['subjects undergoing OIT'],"['Oral immunotherapy (OIT', 'dissect peanut-specific immunoglobulin E (IgE']",[],"[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C1270751', 'cui_str': 'Peanut specific immunoglobulin E'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}]",[],,0.0290541,We observe a striking diversification and boosting of the peanut-specific IgG repertoire after OIT and a reduction in pre-existing IgE levels against individual epitopes.,"[{'ForeName': 'Genghao', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Genetics, Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Ellen L', 'Initials': 'EL', 'LastName': 'Shrock', 'Affiliation': 'Department of Genetics, Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Mamie Z', 'Initials': 'MZ', 'LastName': 'Li', 'Affiliation': 'Department of Genetics, Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Spergel', 'Affiliation': ""Division of Allergy and Immunology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Nadeau', 'Affiliation': 'Department of Medicine, Sean N Parker Center for Allergy and Asthma Research, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Pongracic', 'Affiliation': 'Division of Pediatric Allergy and Immunology, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Dale T', 'Initials': 'DT', 'LastName': 'Umetsu', 'Affiliation': ""Division of Immunology, Department of Pediatrics, Boston Children's Hospital, Boston, MA 02115, USA.""}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Rachid', 'Affiliation': ""Division of Immunology, Department of Pediatrics, Boston Children's Hospital, Boston, MA 02115, USA.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'MacGinnitie', 'Affiliation': ""Division of Immunology, Department of Pediatrics, Boston Children's Hospital, Boston, MA 02115, USA.""}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Division of Immunology, Department of Pediatrics, Boston Children's Hospital, Boston, MA 02115, USA.""}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': ""Division of Immunology, Department of Pediatrics, Boston Children's Hospital, Boston, MA 02115, USA.""}, {'ForeName': 'Hans C', 'Initials': 'HC', 'LastName': 'Oettgen', 'Affiliation': ""Division of Immunology, Department of Pediatrics, Boston Children's Hospital, Boston, MA 02115, USA.""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Elledge', 'Affiliation': 'Department of Genetics, Harvard Medical School, Boston, MA 02115, USA.'}]",Cell reports. Medicine,['10.1016/j.xcrm.2021.100410']
3103,34875850,Effect of age on outcomes after allogeneic disc tissue supplementation in patients with chronic discogenic low back pain in the VAST trial.,"Aim:  To explore the effects of viable allogeneic disc tissue supplementation in younger patients with discogenic chronic low back pain (CLBP).  Patients & methods:  VAST was a randomized placebo-controlled trial of disc allograft supplementation in 218 patients with discogenic CLBP. We conducted a  post hoc  analysis of change from baseline to 12 months in Oswestry Disability Index (ODI) and visual analog scale for pain intensity scores stratified by patient age.  Results:  Patients aged <42 years receiving allograft experienced greater improvement in ODI (p = 0.042) and a higher ODI response rate (≥10-, ≥15- and ≥20-point reductions in ODI) than those receiving saline (p = 0.001, p = 0.002 and p = 0.021, respectively).  Conclusion:  Young patients with discogenic CLBP may have significant functional improvement following nonsurgical disc allograft supplementation.",2022,"experienced greater improvement in ODI (p = 0.042) and a higher ODI response rate (≥10-, ≥15- and ≥20-point reductions in ODI) than those receiving saline (p = 0.001, p = 0.002 and p = 0.021, respectively).  ","['Young patients with discogenic CLBP', '218 patients with discogenic CLBP', 'younger patients with discogenic chronic low back pain (CLBP', 'patients with chronic discogenic low back pain in the VAST trial', 'Patients aged <42\xa0years receiving allograft']","['disc allograft supplementation', 'viable allogeneic disc tissue supplementation', 'allogeneic disc tissue supplementation', 'placebo']","['higher ODI response rate', 'ODI', 'Oswestry Disability Index (ODI) and visual analog scale for pain intensity scores']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",218.0,0.255907,"experienced greater improvement in ODI (p = 0.042) and a higher ODI response rate (≥10-, ≥15- and ≥20-point reductions in ODI) than those receiving saline (p = 0.001, p = 0.002 and p = 0.021, respectively).  ","[{'ForeName': 'Corey W', 'Initials': 'CW', 'LastName': 'Hunter', 'Affiliation': 'Ainsworth Institute of Pain Management, 115 East 57th Street, Suite 1210, New York, NY 10022, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Guyer', 'Affiliation': 'Texas Back Institute Research Foundation, 6020 W. Parker Road, Suite 200, Plano, TX 75093, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Froimson', 'Affiliation': 'Riverside Health Advisors, Chagrin Falls, OH 44022, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'DePalma', 'Affiliation': 'Virginia iSpine Physicians, 9020 Stony Point Parkway, Suite 140, Richmond, VA 23235, USA.'}]",Pain management,['10.2217/pmt-2021-0078']
3104,34872065,Starving Your Performance? Reduced Preexercise Hunger Increases Resistance Exercise Performance.,"BACKGROUND


Preexercise food intake enhances exercise performance due, in part, to the provision of exogenous carbohydrate. Food intake also suppresses hunger, but the specific influence of hunger on exercise performance has not been investigated. This study aimed to manipulate hunger by altering preexercise meal viscosity to examine whether hunger influences performance.
METHODS


Sixteen resistance-trained males completed 2 experimental trials ingesting either high viscosity semisolid (SEM) and low viscosity liquid (LIQ) carbohydrate-containing meals 2 hours before performing 4 sets of back squat (85 [22] kg) and bench press (68 [13] kg) to failure at 90% 10-repetition maximum. Subjective hunger/fullness as well as plasma concentrations of glucose, insulin, ghrelin, and peptide tyrosine-tyrosine were measured before and periodically after the meal. Repetitions completed in sets were used to determine exercise performance.
RESULTS


Hunger was lower, and fullness was greater during SEM compared with LIQ immediately before and during exercise (P < .05). Total repetitions completed for back squat were approximately 10% greater in SEM (SEM 57 [9]; LIQ 51 [7] repetitions; P = .001) with no difference in bench press repetitions (SEM 48 [11]; LIQ 48 [10] repetitions; P = .621). Postprandial glucose concentrations were greater during LIQ (12% increase in peak glucose) but were similar throughout exercise.
CONCLUSION


This study demonstrates that exercise performance in back squat was increased in the SEM trial concomitant to a reduction in hunger. Therefore, this study provides novel data that suggest that exercise performance might be influenced by hunger, at least for resistance exercise.",2021,"Subjective hunger/fullness as well as plasma concentrations of glucose, insulin, ghrelin, and peptide tyrosine-tyrosine were measured before and periodically after the meal.",['Sixteen resistance-trained males'],['high viscosity semisolid (SEM) and low viscosity liquid (LIQ) carbohydrate-containing meals 2\xa0hours before performing 4 sets of back squat'],"['Total repetitions completed for back squat', 'back squat', 'peak glucose', 'fullness', 'Hunger', 'Postprandial glucose concentrations', 'Subjective hunger/fullness as well as plasma concentrations of glucose, insulin, ghrelin, and peptide tyrosine-tyrosine', 'Reduced Preexercise Hunger Increases Resistance Exercise Performance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C1720454', 'cui_str': 'Semi-solid dose form'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0077599', 'cui_str': 'tyrosyltyrosine'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0382197,"Subjective hunger/fullness as well as plasma concentrations of glucose, insulin, ghrelin, and peptide tyrosine-tyrosine were measured before and periodically after the meal.","[{'ForeName': 'Mohamed Nashrudin', 'Initials': 'MN', 'LastName': 'Naharudin', 'Affiliation': ''}, {'ForeName': 'Ashril', 'Initials': 'A', 'LastName': 'Yusof', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Clayton', 'Affiliation': ''}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2021-0166']
3105,34871344,Prenatal supplementation with multiple micronutrient supplements or medium-quantity lipid-based nutrient supplements has limited effects on child growth up to 24 months in rural Niger: a secondary analysis of a cluster randomized trial.,"BACKGROUND


Prenatal multiple micronutrient supplementation (MMS) and lipid-based nutrient supplementation (LNS) can improve birth outcomes relative to iron-folic acid supplementation (IFA); however, effects on child postnatal growth remain unclear.
OBJECTIVES


The aim was to compare the effect of prenatal MMS, medium-quantity LNS (MQ-LNS), and IFA on child growth up to 2 y of age.
METHODS


We conducted a cluster randomized controlled trial of prenatal nutritional supplementation in Madarounfa, Niger. Villages were randomly assigned for pregnant women to receive IFA (17 villages, 1105 women), MMS (18 villages, 1083 women) or MQ-LNS (18 villages, 1144 women). Pregnant women received nutritional supplements weekly until delivery, and children were followed up monthly from 6-8 wk to 24 mo of age. We assessed the effect of prenatal MMS and MQ-LNS compared with IFA and the effect of prenatal MMS compared with MQ-LNS on child length-for-age z scores (LAZ), weight-for-age z scores (WAZ), and weight-for-length z scores (WLZ) at 24 mo of age using generalized linear models. In secondary analyses, we used mixed-effects models to assess the trajectories of anthropometric z scores longitudinally from 6-8 wk to 24 mo.
RESULTS


Compared with IFA, MMS and MQ-LNS had no effect on child LAZ, WAZ, or WLZ at 24 mo of age (P > 0.05). Children in the MQ-LNS arm had significantly higher mid-upper arm circumference at 24 mo than children in the MMS arm: mean difference 0.50 cm (95% CI 0.10, 0.91 cm). WAZ and WLZ trajectories were more negative in the MQ-LNS arm compared with IFA and MMS, with lower z scores from 14 to 20 mo of age. However, WAZ and WLZ trajectories converged after 20 mo of age, and there were no differences by 24 mo of age.
CONCLUSIONS


Prenatal MMS and MQ-LNS had limited effect on anthropometric measures of child growth up to 24 mo of age as compared with IFA in rural Niger.",2022,"WAZ and WLZ trajectories were more negative in the MQ-LNS arm compared with IFA and MMS, with lower z scores from 14 to 20 mo of age.","['18 villages, 1144 women', '17 villages, 1105 women), MMS (18 villages, 1083 women) or', 'child growth up to 2 y of age', 'child growth up to 24 months in rural Niger']","['IFA', 'Prenatal supplementation with multiple micronutrient supplements or medium-quantity lipid-based nutrient supplements', 'prenatal MMS and MQ-LNS', 'prenatal nutritional supplementation', 'nutritional supplements', 'Prenatal multiple micronutrient supplementation (MMS) and lipid-based nutrient supplementation (LNS', 'MQ-LNS', 'prenatal MMS, medium-quantity LNS (MQ-LNS), and IFA']","['child LAZ, WAZ, or WLZ', 'higher mid-upper arm circumference', 'trajectories of anthropometric z scores', 'child length-for-age z scores (LAZ), weight-for-age z scores (WAZ), and weight-for-length z scores (WLZ']","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0028074', 'cui_str': 'Niger'}]","[{'cui': 'C0357067', 'cui_str': 'Folic acid- and iron-containing product'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}]",1144.0,0.182455,"WAZ and WLZ trajectories were more negative in the MQ-LNS arm compared with IFA and MMS, with lower z scores from 14 to 20 mo of age.","[{'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Bliznashka', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Sudfeld', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Souna', 'Initials': 'S', 'LastName': 'Garba', 'Affiliation': 'Epicentre, Niamey, Niger.'}, {'ForeName': 'Ousmane', 'Initials': 'O', 'LastName': 'Guindo', 'Affiliation': 'Epicentre, Niamey, Niger.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Soumana', 'Affiliation': 'Epicentre, Niamey, Niger.'}, {'ForeName': 'Irène', 'Initials': 'I', 'LastName': 'Adehossi', 'Affiliation': 'National Pediatric Hospital, Niamey, Niger.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Langendorf', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}, {'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Grais', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Isanaka', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab404']
3106,35236353,"Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1): a pragmatic stepped-wedge, cluster randomized controlled registry trial.","BACKGROUND


The shortage of available organs for life-saving transplants persists worldwide. While a majority support donating their organs or tissue when they die, many have not registered their wish to do so. When registered, next of kin are much more likely to follow-through with the decision to donate. In many countries, most people visit their family physician office each year and this setting is a promising, yet underused, site where more people could register for deceased organ donation. Our primary aim was to evaluate the effectiveness of an intervention to promote organ donation registration in family physician's offices.
METHODS


We developed an intervention to address barriers and enablers to organ donation registration that involved physician office reception staff inviting patients to register on a tablet in the waiting room while they waited for their appointment. We conducted a cross-sectional stepped-wedge cluster randomized controlled registry trial to evaluate the intervention. We recruited six family physician offices in Canada. All offices began with usual care and then every two weeks, one office (randomly assigned) started the intervention until all offices delivered the intervention. The primary outcome was registration for deceased organ donation in the provincial organ registration registry, assessed within the 7 days of the physician visit. At the end of the trial, we also conducted interviews with clinic staff to assess any barriers and enablers to delivering the intervention.
RESULTS


The trial involved 24,616 patient visits by 13,562 unique patients: 12,484 visits in the intervention period and 12,132 in the control period. There was no statistically significant difference in the percentage of patients registered for deceased organ donation in the intervention versus control period (48.0% vs 46.2%; absolute difference after accounting for the secular trend: 0.12%; 95% CI: - 2.30, 2.54; p=0.92). Interviews with clinic staff indicated location of the tablet within a waiting room, patient rapport, existing registration, confidence and motivation to deliver the intervention and competing priorities as barriers and enablers to delivery.
CONCLUSIONS


Our intervention did not increase donor registration. Nonetheless, family physician offices may still remain a promising setting to develop and evaluate better interventions to increase organ donation registration.
TRIAL REGISTRATION


NCT03213171.",2022,"There was no statistically significant difference in the percentage of patients registered for deceased organ donation in the intervention versus control period (48.0% vs 46.2%; absolute difference after accounting for the secular trend: 0.12%; 95% CI: - 2.30, 2.54; p=0.92).","[""family physician's offices"", 'six family physician offices in Canada', '24,616 patient visits by 13,562 unique patients: 12,484 visits in the intervention period and 12,132 in the control period', 'family physician waiting rooms (RegisterNow-1']",[],"['registration for deceased organ donation', 'deceased organ donation']","[{'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}]",24616.0,0.0704551,"There was no statistically significant difference in the percentage of patients registered for deceased organ donation in the intervention versus control period (48.0% vs 46.2%; absolute difference after accounting for the secular trend: 0.12%; 95% CI: - 2.30, 2.54; p=0.92).","[{'ForeName': 'Alvin Ho-Ting', 'Initials': 'AH', 'LastName': 'Li', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada. ali66@uwo.ca.'}, {'ForeName': 'Amit X', 'Initials': 'AX', 'LastName': 'Garg', 'Affiliation': 'Lawson Health Research Institute, London, ON, Canada.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Versha', 'Initials': 'V', 'LastName': 'Prakash', 'Affiliation': 'Trillium Gift of Life Network, Toronto, ON, Canada.'}, {'ForeName': 'Alexie J', 'Initials': 'AJ', 'LastName': 'Dunnett', 'Affiliation': 'Lawson Health Research Institute, London, ON, Canada.'}, {'ForeName': 'Stephanie N', 'Initials': 'SN', 'LastName': 'Dixon', 'Affiliation': 'Lawson Health Research Institute, London, ON, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': 'Citizen partner, London, ON, Canada.'}, {'ForeName': 'Kyla L', 'Initials': 'KL', 'LastName': 'Naylor', 'Affiliation': 'Institute for Clinical Evaluative Sciences (ICES) Western, London, ON, Canada.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Faulds', 'Affiliation': 'Department of Family Medicine, Western University, London, ON, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Bevan', 'Affiliation': 'Department of Family Medicine, Western University, London, ON, Canada.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Getchell', 'Affiliation': 'Lawson Health Research Institute, London, ON, Canada.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Knoll', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'S Joseph', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Sontrop', 'Affiliation': 'Lawson Health Research Institute, London, ON, Canada.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Tong', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lise M', 'Initials': 'LM', 'LastName': 'Bjerre', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Karyn', 'Initials': 'K', 'LastName': 'Hyjek', 'Affiliation': 'Trillium Gift of Life Network, Toronto, ON, Canada.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Currie', 'Affiliation': 'Citizen partner, London, ON, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Edwards', 'Affiliation': 'Citizen partner, London, ON, Canada.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Sullivan', 'Affiliation': 'Citizen partner, London, ON, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Harvey-Rioux', 'Affiliation': 'Citizen partner, London, ON, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Presseau', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]",BMC medicine,['10.1186/s12916-022-02266-8']
3107,35236302,"An open-label phase 2 trial to assess the efficacy, safety and pharmacokinetics of lanthanum carbonate in hyperphosphatemic children and adolescents with chronic kidney disease undergoing dialysis.","BACKGROUND


This study assessed the efficacy, tolerability and pharmacokinetics (PK) of lanthanum carbonate (LC) in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) undergoing dialysis.
METHODS


This was a three-part, multicenter, open-label study of LC (oral powder formulation) in patients 10 to < 18 years old with CKD undergoing dialysis. In part 1, the single-dose PK of LC (500 mg, ≤12 years old; 1000 mg, > 12 years old) were summarized. In part 2, patients received calcium carbonate (CC [chewable tablet formulation]) (1500-6500 mg [total daily dose]) followed by LC (powder formulation) (1500-3000 mg [total daily dose]), or LC only (1500-3000 mg [total daily dose]), each for 8 weeks. During part 3, patients received LC (1500-3000 mg [total daily dose]) for up to 6 months. The primary efficacy endpoint was the proportion of LC-treated patients achieving serum phosphorus control after 8 weeks during parts 2 and/or 3, defined as: ≤1.94 mmol/L, < 12 years old; ≤1.78 mmol/L, ≥12 years old. Secondary efficacy endpoints included: the proportion of patients who achieved serum phosphorus control after 8 weeks of treatment with CC followed by 8 weeks of treatment with LC (with a washout period between treatments). The safety of LC and CC was also evaluated.
RESULTS


In part 1, 20 patients received a single dose of LC. In part 2, 53 and 51 patients were treated with CC and LC for 8 weeks, respectively. During part 3, 42 patients received LC for up to 6 months. Most patients were white and male. For the primary efficacy endpoint, 50% (17/34) of patients who received LC for 8 weeks during parts 2 and/or 3 achieved serum phosphorus control. After 8 weeks of treatment with CC, 58.8% of patients achieved serum phosphorus control; after a subsequent washout period and 8 weeks of treatment with LC, 70.6% of patients achieved serum phosphorus control. T max  and t 1/2  occurred within 3-8 h and ~ 19 h, respectively; however, variability was observed. LC and CC were generally well tolerated.
CONCLUSIONS


These data support the use of LC to manage hyperphosphatemia in pediatric patients with CKD undergoing dialysis.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01696279; EudraCT identifier: 2012-000171-17. Date of registration: 01/10/2012.",2022,"After 8 weeks of treatment with CC, 58.8% of patients achieved serum phosphorus control; after a subsequent washout period and 8 weeks of treatment with LC, 70.6% of patients achieved serum phosphorus control.","['hyperphosphatemic children and adolescents with chronic kidney disease undergoing dialysis', 'Most patients were white and male', 'pediatric patients with CKD undergoing dialysis', 'hyperphosphatemic children and adolescents with chronic kidney disease (CKD) undergoing dialysis', 'patients 10 to <\u200918\u2009years old with CKD undergoing dialysis']","['LC (oral powder formulation', 'LC', 'lanthanum carbonate (LC', 'LC (powder formulation', 'calcium carbonate (CC [chewable tablet formulation', 'CC and LC', 'lanthanum carbonate']","['tolerated', 'efficacy, safety and pharmacokinetics', 'serum phosphorus control', 'proportion of patients who achieved serum phosphorus control', 'efficacy, tolerability and pharmacokinetics (PK', 'proportion of LC-treated patients achieving serum phosphorus control', 'T max  and t 1/2']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C1160731', 'cui_str': 'Oral powder'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0304290', 'cui_str': 'Chewable tablet'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0580272', 'cui_str': '1/2'}]",,0.018813,"After 8 weeks of treatment with CC, 58.8% of patients achieved serum phosphorus control; after a subsequent washout period and 8 weeks of treatment with LC, 70.6% of patients achieved serum phosphorus control.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wasilewska', 'Affiliation': ""Department of Pediatrics and Nephrology, Faculty of Medicine, Medical University of Bialystok, University Children's Clinical Hospital of Bialystok, Waszyngtona, Bialystok, Poland. anna.wasilewska@udsk.pl.""}, {'ForeName': 'Rose Ann', 'Initials': 'RA', 'LastName': 'Murray', 'Affiliation': 'Shire Human Genetic Therapies, Inc., a Takeda Company, Cambridge, MA, USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Sundberg', 'Affiliation': 'Shire Human Genetic Therapies, Inc., a Takeda Company, Cambridge, MA, USA.'}, {'ForeName': 'Sharif', 'Initials': 'S', 'LastName': 'Uddin', 'Affiliation': 'Takeda Pharmaceuticals USA, Inc., Lexington, MA, USA.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Achenbach', 'Affiliation': 'Shire Human Genetic Therapies, Inc., a Takeda Company, Zug, Switzerland.'}, {'ForeName': 'Aleksey', 'Initials': 'A', 'LastName': 'Shavkin', 'Affiliation': ""Saint Petersburg State Budgetary Healthcare Institution, Children's City Multidisciplinary Clinical Specialized Center of High Medical Technologies, Saint Petersburg, Russia.""}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Szabó', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vergani', 'Affiliation': 'Shire Human Genetic Therapies, Inc., a Takeda Company, Cambridge, MA, USA.'}, {'ForeName': 'Obi', 'Initials': 'O', 'LastName': 'Umeh', 'Affiliation': 'Shire Human Genetic Therapies, Inc., a Takeda Company, Cambridge, MA, USA.'}]",BMC nephrology,['10.1186/s12882-022-02688-9']
3108,35236281,Impact of a procalcitonin-based algorithm on the quality of management of patients with uncomplicated adhesion-related small bowel obstruction assessed by a textbook outcome: a multicenter cluster-randomized open-label controlled trial.,"BACKGROUND


Acute adhesion-related small bowel obstruction (ASBO) is a common digestive emergency, accounting for 1 to 3% of all digestive emergencies. The efficacy of conservative management in this setting is a subject of debate, as it may delay the decision to perform surgery and increase the frequency of bowel resection (e.g., in the presence of bowel necrosis) or, in contrast, prompt an excessive number of unnecessary laparotomies. Thus, the decision to perform surgery is difficult. We propose that the introduction of the procalcitonin (PCT)-based algorithm improves the quality of the management of patients with ASBO by aiding the decision of whether or not to perform surgery.
METHODS


This is a 1:1 cluster-randomized clinical trial (use of algorithm: no algorithm) using an independent computer to ensure that investigators cannot interfere with the randomization. Each cluster will correspond to one investigating center. All patients in a center will be managed in the same way. Before randomization, each principal investigator will provide a commitment to participate in the study to avoid the risk of ""empty clusters"". The patients included will constitute two parallel arms (use of algorithm versus no algorithm), with no expected crossover between arms. The inclusion criteria are being an adult with uncomplicated acute ASBO (i.e., absence of fever, abdominal pain and distension, nausea and/or vomiting, and the absence of gas and/or stool, in conjunction with a contrast-enhanced CT scan, for patients with previous abdominal surgery) who is able to express consent with a signed written informed consent form. Patients with complicated acute ASBO (strangulation or peritonitis) will be excluded.
DISCUSSION


There is an ongoing debate on the management of uncomplicated ASBO. The main points are to avoid a surgery if it is unnecessary and to avoid delayed surgery if it is necessary. Currently, there are no robust criteria to objectively determine the failure of non-surgical treatment or to establish the indications for surgery in acute ASBO. Our team proposes the use of procalcitonin (PCT) to help distinguish patients for whom conservative management is likely to be successful from those for whom surgical management is required. The results from a randomized control trial could help in the selection of patients through clear inclusion and exclusion criteria and simplify or clarify the management algorithm. In conclusion, PCT may be useful in evaluating the proper strategy for ASBO. Trial registration The trial is registered at clinical trials under the reference: NCT03905239.",2022,"Currently, there are no robust criteria to objectively determine the failure of non-surgical treatment or to establish the indications for surgery in acute ASBO.","['patients with previous abdominal surgery) who is able to express consent with a signed written informed consent form', 'Patients with complicated acute ASBO (strangulation or peritonitis', 'patients with uncomplicated adhesion-related small bowel obstruction assessed by a textbook outcome']","['procalcitonin (PCT', 'procalcitonin (PCT)-based algorithm', 'procalcitonin-based algorithm', 'PCT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0235329', 'cui_str': 'Small bowel obstruction'}, {'cui': 'C0277631', 'cui_str': 'Death by strangulation'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.0859174,"Currently, there are no robust criteria to objectively determine the failure of non-surgical treatment or to establish the indications for surgery in acute ASBO.","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Sabbagh', 'Affiliation': 'Service de chirurgie digestive, CHU Amiens-Picardie, 1 rond point du Pr Cabrol, 80054, Amiens Cedex 01, France.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Mauvais', 'Affiliation': 'UR7518 SSPC, universite de Picardie Jules Verne, 80000, Amiens, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Tuech', 'Affiliation': 'Service de chirurgie digestive, CHU Rouen, 13 Rue Boucicaut, 76130, Mont Saint Aignan, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tresallet', 'Affiliation': 'Service de chirurgie digestive, CHU Avicenne, APHP, 125 rue de Stalingrad, 93000, Bobigny, France.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Ortega-Debalon', 'Affiliation': 'Service de chirurgie digestive, 3 Rue du FBG Raines, 21000, Dijon, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Mathonnet', 'Affiliation': 'Service de chirurgie digestive, 2 Avenue Martin Luther King, 87042, Limoges, France.'}, {'ForeName': 'Jeremie H', 'Initials': 'JH', 'LastName': 'Lefevre', 'Affiliation': 'Service de chirurgie digestive, CHU Saint Antoine, APHP, 184 rue du faubourg Saint Antoine, 75012, Paris, France.'}, {'ForeName': 'Zaher', 'Initials': 'Z', 'LastName': 'Lakkis', 'Affiliation': 'Service de chirurgie digestive, 3 boulevard Alexandre Fleming, 25000, Besançon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fuks', 'Affiliation': 'Service de chirurgie digestive, CHU Cochin, APHP, 27 rue du faubourg Saint-Jacques, 75014, Paris, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Muscari', 'Affiliation': 'Service de chirurgie digestive, CHU Toulouse, 7 place Lange, 31300, Toulouse, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Dron', 'Affiliation': ""Service de chirurgie digestive, CH Saint Quentin, 1 avenue Michel de l'Hospital, 02100, Saint-Quentin, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Couderc', 'Affiliation': 'Service de chirurgie digestive, CH Pau, 4 boulevard Hauterive, 64000, Pau, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Alves', 'Affiliation': 'Service de chirurgie digestive, CHU de Caen, Avenue de la côte de Nacre, 14033, Caen, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Regimbeau', 'Affiliation': 'Service de chirurgie digestive, CHU Amiens-Picardie, 1 rond point du Pr Cabrol, 80054, Amiens Cedex 01, France. regimbeau.jean-marc@chu-amiens.fr.'}]",BMC gastroenterology,['10.1186/s12876-022-02144-w']
3109,35236256,Horizontal Heterophoria Modifications by Means of Thin Proprioceptive Stimulations Applied on the Foot Sole: A Randomised Study.,"Some authors have demonstrated that proprioceptive stimuli applied on the feet soles can interfere on the ocular muscles. However, these studies do not clarify possible functional differences between the dominant eye and the non-dominant eye. The purpose of this randomised study is to establish if the positioning of an Internal Heel Wedge (IHW) and an External Heel Wedge (EHW) can modify horizontal heterophoria, determine dissimilar behaviours between the dominant eye and the non-dominant eye. Forty-two healthy subjects, with a right dominant eye, were tested. The 1.5 mm-thick proprioceptive stimuli were shaped out of a cork half-moon. The experimental group was divided into two groups: IHW group and EHW group. Both groups performed the ""Baseline"" (without mechanical stimulation) and ""After 15'"" (following a fitting period of 15 minutes on a treadmill with mechanical stimulation) trials. The control group performed the same trials without any podalic stimulation. Meaningful changes were observed on the horizontal heterophoria of the non-dominating eye with an IHW. Non-statistically significant variations were observed with an EHW and in the Control group. A thin heel wedge applied on the foot sole was able to generate functional changes in the non-dominant eye and could help health professionals develop increasingly personalised rehabilitation programmes.",2022,A thin heel wedge applied on the foot sole was able to generate functional changes in the non-dominant eye and could help health professionals develop increasingly personalised rehabilitation programmes.,"['Forty-two healthy subjects, with a right dominant eye, were tested', 'Foot Sole']","['Internal Heel Wedge (IHW) and an External Heel Wedge (EHW', 'IHW group and EHW']",['horizontal heterophoria'],"[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C4721400', 'cui_str': 'Heterophoria'}]",42.0,0.0222138,A thin heel wedge applied on the foot sole was able to generate functional changes in the non-dominant eye and could help health professionals develop increasingly personalised rehabilitation programmes.,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Alessandria', 'Affiliation': 'Department of Life Sciences and Systems Biology, University of Turin, Torino, Italy.'}]",Journal of motor behavior,['10.1080/00222895.2022.2046539']
3110,35236653,Gongning granules plus low dose hormone in pubertal functional uterine hemorrhage: Analysis of hemodynamics and clinical efficacy.,"To evaluate the clinical effect of Gongning granules combined with low-dose hormone therapy in pubertal dysfunctional uterine bleeding (PDUB) and its effect on uterine hemodynamics. A total of 164 PDUB patients who were treated in the gynecological outpatient department of our hospital from December 2018 to June 2020 were randomized into study group and control group, with 82 cases each. The control group received estrogen progesterone, and the study group received Gongning granules plus. The clinical efficacy and uterine arterial hemodynamics were compared. The clinical efficacy of the study group was superior to the control group (91.46% vs. 76.83%, P<0.05). The study group yielded shorter bleeding control time and complete hemostasis time than the control group (P<0.05). The amount of menstrual bleeding and duration of menstruation in both groups decreased significantly with time and the study group was significantly lower than the control group (all P<0.05). The endometrial thickness in the study group was significantly thinner than the control group, and the maximum follicle diameter was significantly longer than that in the control group (all P<0.05). After treatment, the platelet count, hemoglobin level of peripheral blood, uterine arterial blood flow and mean flow velocity in the study group were significantly higher than those in the control group (all P<0.05). In addition, there was no significant difference in adverse drug reaction (ADR) between the two groups (P>0.05). In PDUB patients, Gongning granules plus low-dose hormone can significantly relieve bleeding symptoms, improve hemodynamic status and has good safety.",2022,The study group yielded shorter bleeding control time and complete hemostasis time than the control group (P<0.05).,"['pubertal functional uterine hemorrhage', 'pubertal dysfunctional uterine bleeding (PDUB', '164 PDUB patients who were treated in the gynecological outpatient department of our hospital from December 2018 to June 2020']","['Gongning granules combined with low-dose hormone therapy', 'Gongning granules plus low dose hormone', 'estrogen progesterone, and the study group received Gongning granules plus']","['menstrual bleeding and duration of menstruation', 'endometrial thickness', 'platelet count, hemoglobin level of peripheral blood, uterine arterial blood flow and mean flow velocity', 'maximum follicle diameter', 'hemodynamic status', 'bleeding symptoms', 'adverse drug reaction (ADR', 'clinical efficacy', 'clinical efficacy and uterine arterial hemodynamics', 'shorter bleeding control time and complete hemostasis time']","[{'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042134', 'cui_str': 'Uterine haemorrhage'}, {'cui': 'C0025874', 'cui_str': 'Intermenstrual bleeding - irregular'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}]",164.0,0.0293621,The study group yielded shorter bleeding control time and complete hemostasis time than the control group (P<0.05).,"[{'ForeName': 'Xinlong', 'Initials': 'X', 'LastName': 'Gong', 'Affiliation': ""People's Hospital of Mengyin County, Mengyin County, Linyi City, Shandong Province, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Gaomi maternal and Child Health Hospital, Weifang City, Shandong Province, China.'}, {'ForeName': 'Lige', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""The 970th Hospital of the Joint Logistic Support Force of the People's Liberation Army, Yantai City, Shandong Province, China.""}]",Pakistan journal of pharmaceutical sciences,[]
3111,35236647,Efficacy of cisplatin plus paclitaxel as chemotherapy in patients with cervical cancer after laparoscopic nerve-sparing extensive hysterectomy and its effect on immune function.,"To investigate the value of cisplatin plus paclitaxel in patients with middle and advanced cervical cancer after laparoscopic nerve-sparing extensive hysterectomy and its effect on their T lymphocyte subsets. 44 patients with middle and advanced cervical cancer were randomly divided into the control group (n = 22) and the observation group (n = 22). Patients in the control group received nab-paclitaxel as chemotherapy, while patients in the observation group received cisplatin plus nab-paclitaxel as adjuvant therapy. The local recurrence and distant metastasis rates were statistically analyzed after 1 year of follow-up. The overall effective rate in the observation group was significantly higher than that in the control group (P<0.05). The serum levels of IL-4, IL-10 and TNF-α in the two groups were reduced markedly after treatment than before treatment (P<0.05) and the observation group was significantly lower than the control group (P<0.05). After treatment, the proportion of CD3 +  and CD4 +  cells increased, the proportion of CD8 +  cells decreased more significantly than that in the control group (P<0.05). The combination of cisplatin and paclitaxel was demonstrated to have obviously synergistic and attenuated effects after middle and advanced cervical cancer surgery, optimize the efficacy, reduce adverse effects, and improve the body's immune function.",2022,"The serum levels of IL-4, IL-10 and TNF-α in the two groups were reduced markedly after treatment than before treatment (P<0.05) and the observation group was significantly lower than the control group (P<0.05).","['patients with cervical cancer after laparoscopic nerve-sparing extensive hysterectomy', 'patients with middle and advanced cervical cancer after laparoscopic nerve-sparing extensive hysterectomy', '44 patients with middle and advanced cervical cancer']","['cisplatin and paclitaxel', 'nab-paclitaxel as chemotherapy', 'cisplatin plus paclitaxel', 'cisplatin plus nab-paclitaxel as adjuvant therapy']","['proportion of CD3 +  and CD4 +  cells', 'serum levels of IL-4, IL-10 and TNF-α', 'proportion of CD8 +  cells', 'overall effective rate', 'local recurrence and distant metastasis rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C3251824', 'cui_str': 'Cell positive for CD4 antigen'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C4316924', 'cui_str': 'CD8+ cell'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1269798', 'cui_str': 'pM category'}]",44.0,0.05337,"The serum levels of IL-4, IL-10 and TNF-α in the two groups were reduced markedly after treatment than before treatment (P<0.05) and the observation group was significantly lower than the control group (P<0.05).","[{'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecology, Cangxian County Hospital, Cangzhou, Hebei, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'Department of Internal Medicine, Cangxian County Hospital, Cangzhou, Hebei, China.'}, {'ForeName': 'Bingqin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Gynecology, Cangxian County Hospital, Cangzhou, Hebei, China.'}]",Pakistan journal of pharmaceutical sciences,[]
3112,35236646,"Effects of butylphthalide on the levels of serum C-reactive protein, Parkinson disease protein 7 and neurotrophin-3 and neurological function in patients with acute cerebral infarction.","To explore the effects of butylphthalide on the levels of serum CRP, PAPK7, NT-3 and neurological function in patients with acute cerebral infarction (ACI). 120 patients with ACI who were treated at Peking University First Hospital from September 2014 to June 2016 were selected as the research objects. The patients were randomly divided into a control group and an observation group, with 60 cases in each group. Conventional methods were adopted in the control group, and the observation group used butylphthalide for treatment. Two months later, the clinical efficacy, serum C-reactive protein (CRP), Parkinson's disease protein 7 (PAPK7), neurotrophic factor-3 (NT-3) levels, and the National Institutes of Health Stroke Scale (NIHSS) score before and after treatment were put into comparison and analysis. Before treatment, the NIHSS score showed no significant difference between the two groups (p>0.05); An observably higher NIHSS score of the observation group compared with the control group was seen after treatment (p=0.000). Butylphthalide has a significant therapeutic effect on patients with ACI. It can effectively restore the patients' neurological function, and remarkably improve the serum CRP, PAPK7 and NT-3 levels, which is worthy of clinical promotion.",2022,"Before treatment, the NIHSS score showed no significant difference between the two groups (p>0.05); An observably higher NIHSS score of the observation group compared with the control group was seen after treatment (p=0.000).","['120 patients with ACI who were treated at Peking University First Hospital from September 2014 to June 2016 were selected as the research objects', 'patients with acute cerebral infarction', 'patients with acute cerebral infarction (ACI', 'patients with ACI']","['Butylphthalide', 'butylphthalide']","['levels of serum C-reactive protein, Parkinson disease protein 7 and neurotrophin-3 and neurological function', 'serum CRP, PAPK7 and NT-3 levels', 'NIHSS score', ""clinical efficacy, serum C-reactive protein (CRP), Parkinson's disease protein 7 (PAPK7), neurotrophic factor-3 (NT-3) levels, and the National Institutes of Health Stroke Scale (NIHSS) score"", 'serum CRP, PAPK7, NT-3 and neurological function']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]","[{'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0537311', 'cui_str': 'PARK7 protein, human'}, {'cui': 'C0083735', 'cui_str': 'Neurotrophin 3'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C3887787', 'cui_str': 'neurotrophin-3, human'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}]",120.0,0.0112194,"Before treatment, the NIHSS score showed no significant difference between the two groups (p>0.05); An observably higher NIHSS score of the observation group compared with the control group was seen after treatment (p=0.000).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': ""Neurology Department, Shanxi Jinzhong Second People's Hospital, Jinzhong, Shanxi Province, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': ""Imaging Department, Shanxi Jinzhong Second People's Hospital, Jinzhong, Shanxi Province, China.""}, {'ForeName': 'Runting', 'Initials': 'R', 'LastName': 'Jing', 'Affiliation': ""Neurology Department, Zichang People's Hospital of Shaanxi Province, Zichang, Shan'xi Province, China.""}, {'ForeName': 'Lixi', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': ""Neurology Department, Yanhu Branch of The First Hospital of Shanxi Medical University, Shan'xi Province, China.""}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Neurology Department, First Hospital of Yuncheng City, Shanxi Province, China.'}, {'ForeName': 'Guojin', 'Initials': 'G', 'LastName': 'Ren', 'Affiliation': ""Neurology Department, Shanxi Jinzhong Second People's Hospital, Jinzhong, Shanxi Province, China.""}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': ""Department of Critical Care Medicine, Shanxi Jinzhong Second People's Hospital, Jinzhong, Shanxi Province, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Che', 'Affiliation': ""Neurology Department, Shanxi Jinzhong Second People's Hospital, Jinzhong, Shanxi Province, China.""}]",Pakistan journal of pharmaceutical sciences,[]
3113,35236645,Clinical effect of combination of octreotide and omeprazole in children with acute upper gastrointestinal bleeding and the levels of serum creatinine and serum urea nitrogen.,"Pediatric upper gastrointestinal bleeding refers to an acute massive hemorrhage of the upper digestive tract and biliary tract, which is a common clinical emergency in pediatrics. This study aimed to evaluate the clinical effect of octreotide combined with omeprazole in pediatric upper gastrointestinal bleeding. Totally 84 cases of pediatric upper gastrointestinal bleeding admitted to Ningbo Women and Children's Hospital from November 2019 to April 2021 were divided into groups according to the admission order. The control group received omeprazole treatment and the observation group received octreotide plus. The total clinical effective rate of children in the observation group was higher than that of the control group. The observation group was superior to the control group with respect to the average hemostasis time, hemostasis rate, rebleeding rate and length of stay after treatment. The observation group witnessed a significantly better quality of life than the control group. For children with acute upper gastrointestinal bleeding, the combination of omeprazole and octreotide yields a promising effect in the adjustment of blood creatinine and serum urea nitrogen levels and hemostasis, which is worthy of clinical application.",2022,"The observation group was superior to the control group with respect to the average hemostasis time, hemostasis rate, rebleeding rate and length of stay after treatment.","['children with acute upper gastrointestinal bleeding and the levels of serum creatinine and serum urea nitrogen', 'children with acute upper gastrointestinal bleeding', 'pediatric upper gastrointestinal bleeding', ""Totally 84 cases of pediatric upper gastrointestinal bleeding admitted to Ningbo Women and Children's Hospital from November 2019 to April 2021""]","['omeprazole and octreotide', 'octreotide and omeprazole', 'octreotide plus', 'omeprazole', 'octreotide combined with omeprazole']","['average hemostasis time, hemostasis rate, rebleeding rate and length of stay', 'total clinical effective rate', 'quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0266809', 'cui_str': 'Acute upper gastrointestinal hemorrhage'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0856666', 'cui_str': 'Serum urea'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal bleeding'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",84.0,0.0111668,"The observation group was superior to the control group with respect to the average hemostasis time, hemostasis rate, rebleeding rate and length of stay after treatment.","[{'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Hao', 'Affiliation': ""Ningbo Women and Children's Hospital, Ningbo, China.""}, {'ForeName': 'Longfan', 'Initials': 'L', 'LastName': 'Piao', 'Affiliation': 'Department of Surgical Nursing, School of Nursing, Yanbian University, Jilin, China.'}, {'ForeName': 'Maojie', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': ""Pharmacy Department, Chongqing The Seventh People's Hospital, Chongqing, China.""}, {'ForeName': 'Fanzhuo', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': ""The People's Hospital of Dadukou District, Chongqing, China.""}]",Pakistan journal of pharmaceutical sciences,[]
3114,35236568,Tumour-infiltrating lymphocytes add prognostic information for patients with low-risk DCIS: findings from the SweDCIS randomised radiotherapy trial.,"BACKGROUND


The immune microenvironment is an important modulator of tumour progression and treatment response. In invasive breast cancer, assessment of tumour-infiltrating lymphocytes (TILs) provides prognostic and predictive information. However, the clinical impact of TILs for ductal carcinoma in situ (DCIS) has not yet been demonstrated.
PATIENTS AND METHODS


Post hoc analysis of the SweDCIS randomised radiotherapy trial including primary DCIS cases following breast-conserving surgery. TILs were assessed on haematoxylin-eosin sections (n = 711) according to the International Immuno-Oncology Biomarker Working Group guidelines. TILs-scores were analysed as continuous and dichotomised (≤5% versus >5%) variable regarding ipsilateral breast events (IBEs) as the predefined primary endpoint.
RESULTS


Most women (61.9%) showed a TILs prevalence of ≤5%. High TILs-scores were associated with larger lesion size, human epidermal growth factor receptor 2 (HER2)-positivity, higher nuclear grade, and KI67-score. DCIS cases with high TILs prevalence had a significant increased cumulative IBE incidence at five years post-surgery (TILs low -versus TILs high  9% versus 18%; p < 0.001). Among patients with HER2-negative DCIS, high TILs remained an independent poor prognosis marker for IBE risk in multivariable analysis with an adjusted hazard ratio of 2.41 [95%CI 1.17-4.95, p = 0.017]. Including TILs-status provided a refined stratification of patients with general low-risk DCIS (grade <3, size <25 mm, free margin). No interaction between TILs and radiotherapy benefits was detected.
CONCLUSION


High TILs are associated with higher IBE risk over 5-years post-surgery, particularly for HER2-negative DCIS. Our data indicate that TILs should be integrated into the clinical workup to define patients with low-risk DCIS who can omit adjuvant therapy or patients with potential benefits from immunotherapy.",2022,"High TILs-scores were associated with larger lesion size, human epidermal growth factor receptor 2 (HER2)-positivity, higher nuclear grade, and KI67-score.","['patients with low-risk DCIS', 'patients with low-risk DCIS who can omit adjuvant therapy or patients with potential benefits from immunotherapy', 'patients with general low-risk DCIS (grade <3, size <25\xa0mm, free margin']",['breast-conserving surgery'],"['IBE risk', 'cumulative IBE incidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}]","[{'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.13667,"High TILs-scores were associated with larger lesion size, human epidermal growth factor receptor 2 (HER2)-positivity, higher nuclear grade, and KI67-score.","[{'ForeName': 'Aglaia', 'Initials': 'A', 'LastName': 'Schiza', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Thurfjell', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Stenmark Tullberg', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Olofsson', 'Affiliation': 'Department of Pathology, Centre for Clinical Research of Uppsala University, Vastmanland´s Hospital Vasterås, Sweden.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lindberg', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Bremer', 'Affiliation': 'PreludeDx, Laguna Hills, CA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Micke', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Wärnberg', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Strell', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden. Electronic address: carina.strell@igp.uu.se.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2022.01.016']
3115,35236778,Impact of the food grade heat-killed probiotic and postbiotic oral lozenges in oral hygiene.,"The oral cavity plays a crucial role in food digestion and immune protection. Thus, maintaining oral health is necessary. Postbiotic and heat-killed probiotic cells have shown increased antibacterial potential with stable viability compared with live strains. However, clinical evidence regarding their effect on oral health is insufficient. Therefore, in this study, we tested postbiotic lozenges of  Lactobacillus salivarius  subsp.  salicinius  AP-32,  L. paracasei  ET-66, and  L. plantarum  LPL28 and heat-killed probiotic lozenges of  L. salivarius  subsp.  salicinius  AP-32 and  L. paracasei  ET-66 for their effect on oral health. In total, 75 healthy individuals were blindly and randomly divided into placebo, postbiotic lozenge, and heat-killed probiotic lozenge groups and were administered the respective lozenge type for 4 weeks. Postbiotic and heat-killed probiotic lozenge groups demonstrated antibacterial activities with a considerable increase in  L. salivarius  in their oral cavity. Furthermore, their salivary immunoglobulin A,  Lactobacillus , and  Bifidobacterium  increased. Subjective questionnaires completed by the participants indicated that participants in both the experimental groups developed better oral health and intestinal conditions than those in the placebo group. Overall, our study revealed that a food additive in the form of an oral postbiotic or heat-killed probiotic lozenge may effectively enhance oral immunity, inhibit the growth of oral pathogens, and increase the numbers of beneficial oral microbiota.",2022,Postbiotic and heat-killed probiotic lozenge groups demonstrated antibacterial activities with a considerable increase in  L. salivarius  in their oral cavity.,"['oral hygiene', '75 healthy individuals']","['placebo', 'placebo, postbiotic lozenge, and heat-killed probiotic lozenge', 'food grade heat-killed probiotic and postbiotic oral lozenges', 'Postbiotic and heat-killed probiotic cells', 'LPL28 and heat-killed probiotic lozenges']","['oral health and intestinal conditions', 'antibacterial activities', 'numbers of beneficial oral microbiota', 'Subjective questionnaires']","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162388', 'cui_str': 'Killing'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",75.0,0.0631896,Postbiotic and heat-killed probiotic lozenge groups demonstrated antibacterial activities with a considerable increase in  L. salivarius  in their oral cavity.,"[{'ForeName': 'Chiao-Wen', 'Initials': 'CW', 'LastName': 'Lin', 'Affiliation': 'Institute of Oral Sciences, Chung Shan Medical University, Taichung, Taiwan.'}, {'ForeName': 'Yi-Tzu', 'Initials': 'YT', 'LastName': 'Chen', 'Affiliation': 'Institute of Oral Sciences, Chung Shan Medical University, Taichung, Taiwan.'}, {'ForeName': 'Hsieh-Hsun', 'Initials': 'HH', 'LastName': 'Ho', 'Affiliation': 'Research and Development Department, Bioflag Biotech Co., Ltd., Tainan, Taiwan.'}, {'ForeName': 'Yi-Wei', 'Initials': 'YW', 'LastName': 'Kuo', 'Affiliation': 'Research and Development Department, Bioflag Biotech Co., Ltd., Tainan, Taiwan.'}, {'ForeName': 'Wen-Yang', 'Initials': 'WY', 'LastName': 'Lin', 'Affiliation': 'Research and Development Department, Bioflag Biotech Co., Ltd., Tainan, Taiwan.'}, {'ForeName': 'Jui-Fen', 'Initials': 'JF', 'LastName': 'Chen', 'Affiliation': 'Research and Development Department, Bioflag Biotech Co., Ltd., Tainan, Taiwan.'}, {'ForeName': 'Jia-Hung', 'Initials': 'JH', 'LastName': 'Lin', 'Affiliation': 'Research and Development Department, Bioflag Biotech Co., Ltd., Tainan, Taiwan.'}, {'ForeName': 'Cheng-Ruei', 'Initials': 'CR', 'LastName': 'Liu', 'Affiliation': 'Research and Development Department, Bioflag Biotech Co., Ltd., Tainan, Taiwan.'}, {'ForeName': 'Chi-Huei', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Research and Development Department, Bioflag Biotech Co., Ltd., Tainan, Taiwan.'}, {'ForeName': 'Yao-Tsung', 'Initials': 'YT', 'LastName': 'Yeh', 'Affiliation': 'Aging and Disease Prevention Research Center, Fooyin University, Kaohsiung, Taiwan.'}, {'ForeName': 'Ching-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Research and Development Department, Bioflag Biotech Co., Ltd., Tainan, Taiwan.'}, {'ForeName': 'Yu-Fen', 'Initials': 'YF', 'LastName': 'Huang', 'Affiliation': 'Research and Development Department, Bioflag Biotech Co., Ltd., Tainan, Taiwan.'}, {'ForeName': 'Chen-Hung', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'Research and Development Department, Bioflag Biotech Co., Ltd., Tainan, Taiwan.'}, {'ForeName': 'Pei-Shan', 'Initials': 'PS', 'LastName': 'Hsieh', 'Affiliation': 'Research and Development Department, Bioflag Biotech Co., Ltd., Tainan, Taiwan.'}, {'ForeName': 'Shun-Fa', 'Initials': 'SF', 'LastName': 'Yang', 'Affiliation': 'Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.'}]",Aging,['10.18632/aging.203923']
3116,35236764,Bayesian analysis of amiodarone or lidocaine versus placebo for out-of-hospital cardiac arrest.,"OBJECTIVE


Clinical trials for patients with shock-refractory out-of-hospital cardiac arrest (OHCA), including the Amiodarone, Lidocaine or Placebo (ALPS) trial, have been unable to demonstrate definitive benefit after treatment with antiarrhythmic drugs. A Bayesian approach, combining the available evidence, may yield additional insights.
METHODS


We conducted a reanalysis of the ALPS trial comparing treatment with amiodarone or lidocaine with placebo in patients with OHCA following shock-refractory ventricular fibrillation or ventricular tachycardia (VF/VT). We used Bayesian regression to assess the probability of improved survival or improved neurological outcome on the 7-point modified Rankin Scale. We derived weak, moderate and strong priors from a previous clinical trial.
RESULTS


The original ALPS trial randomised 3026 adult patients with OHCA to amiodarone (n=974, survival to hospital discharge 24.4%), lidocaine, (n=993, survival 23.7%) or placebo (n=1059, survival 21.0%). In our reanalysis the probability of improved survival from amiodarone ranged from 83% (strong prior) to 95% (weak prior) compared with placebo and from 78% (strong) to 90% (weak) for lidocaine-an estimated improvement in survival of 2.9% (IQR 1.4%-3.8%) for amiodarone and 1.7% (IQR 0.84%-3.2%) for lidocaine over placebo (moderate prior). The probability of improved neurological outcome from amiodarone ranged from 96% (weak) to 99% (strong) compared with placebo and from 88% (weak) to 96% (strong) for lidocaine.
CONCLUSIONS


In a Bayesian reanalysis of patients with shock-resistant VF/VT OHCA, treatment with amiodarone had high probabilities of improved survival and neurological outcome, while treatment with lidocaine had a more modest benefit.",2022,We used Bayesian regression to assess the probability of improved survival or improved neurological outcome on the 7-point modified Rankin Scale.,"['patients with shock-refractory out-of-hospital cardiac arrest (OHCA), including the', 'out-of-hospital cardiac arrest', 'patients with OHCA following shock-refractory ventricular fibrillation or ventricular tachycardia (VF/VT', '3026 adult patients with OHCA to amiodarone (n=974, survival to hospital discharge 24.4']","['lidocaine', 'placebo', 'Amiodarone, Lidocaine or Placebo (ALPS', 'amiodarone or lidocaine', 'amiodarone or lidocaine with placebo', 'amiodarone']","['survival', 'probability of improved survival', 'probability of improved neurological outcome', 'survival and neurological outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0349412', 'cui_str': 'Refractory shock'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}, {'cui': 'C0042514', 'cui_str': 'Ventricular tachycardia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",3026.0,0.228321,We used Bayesian regression to assess the probability of improved survival or improved neurological outcome on the 7-point modified Rankin Scale.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lane', 'Affiliation': 'Emergency Medicine, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada djlane@ucalgary.ca.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Grunau', 'Affiliation': 'Emergency Medicine, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kudenchuk', 'Affiliation': 'Department of Medicine, Division of Cardiology, Arrhythmia Services, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorian', 'Affiliation': 'Department of Medicine, Division of Cardiology, Unity Health Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Henry E', 'Initials': 'HE', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency Medicine, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Department of Emergency Medicine, Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Lupton', 'Affiliation': 'Department of Emergency Medicine, Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vaillancourt', 'Affiliation': 'Department of Emergency Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Okubo', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Davis', 'Affiliation': 'Department of Emergency Medicine, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rea', 'Affiliation': 'Department of General Internal Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Demetris', 'Initials': 'D', 'LastName': 'Yannopoulos', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Christenson', 'Affiliation': 'Emergency Medicine, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Scheuermeyer', 'Affiliation': 'Emergency Medicine, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2021-320513']
3117,35236763,Routine lung volume recruitment in boys with Duchenne muscular dystrophy: a randomised clinical trial.,"BACKGROUND


Impaired cough results in airway secretion retention, atelectasis and pneumonia in individuals with Duchenne muscular dystrophy (DMD). Lung volume recruitment (LVR) stacks breaths to inflate the lungs to greater volumes than spontaneous effort. LVR is recommended in DMD clinical care guidelines but is not well studied. We aimed to determine whether twice-daily LVR, compared with standard of care alone, attenuates the decline in FVC at 2 years in boys with DMD.
METHODS


In this multicentre, assessor-blinded, randomised controlled trial, boys with DMD, aged 6-16 years with FVC >30% predicted, were randomised to receive conventional treatment or conventional treatment plus manual LVR twice daily for 2 years. The primary outcome was FVC % predicted at 2 years, adjusted for baseline FVC % predicted, age and ambulatory status. Secondary outcomes included change in chest wall distensibility (maximal insufflation capacity minus FVC) and peak cough flow.
RESULTS


Sixty-six boys (36 in LVR group, 30 in control) were evaluated (median age (IQR): 11.5 years (9.5-13.5), median baseline FVC (IQR): 85% predicted (73-96)). Adjusted mean difference in FVC between groups at 2 years was 1.9% predicted (95% CI -6.9% to 10.7%; p=0.68) in the direction of treatment benefit. We found no differences in secondary outcomes.
CONCLUSION


There was no difference in decline in FVC % predicted with use of twice-daily LVR for boys with DMD and relatively normal lung function. The burden associated with routine LVR may outweigh the benefit. Benefits of LVR to maintain lung health in boys with worse baseline lung function still need to be clarified.
TRIAL REGISTRATION NUMBER


NCT01999075.",2022,There was no difference in decline in FVC % predicted with use of twice-daily LVR for boys with DMD and relatively normal lung function.,"['boys with DMD, aged 6-16 years with FVC >30% predicted', 'boys with Duchenne muscular dystrophy', 'individuals with Duchenne muscular dystrophy (DMD', 'Sixty-six boys (36 in LVR group, 30 in control) were evaluated (median age (IQR): 11.5 years (9.5-13.5), median baseline FVC (IQR): 85% predicted (73-96', 'FVC at 2\u2009years in boys with DMD']","['conventional treatment or conventional treatment plus manual LVR', 'LVR']","['change in chest wall distensibility (maximal insufflation capacity minus FVC) and peak cough flow', 'FVC', 'Lung volume recruitment (LVR) stacks breaths']","[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C4517559', 'cui_str': '13.5'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1710178', 'cui_str': 'Breath stacking'}]",,0.587557,There was no difference in decline in FVC % predicted with use of twice-daily LVR for boys with DMD and relatively normal lung function.,"[{'ForeName': 'Sherri L', 'Initials': 'SL', 'LastName': 'Katz', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada skatz@cheo.on.ca.""}, {'ForeName': 'Jean K', 'Initials': 'JK', 'LastName': 'Mah', 'Affiliation': ""Division of Pediatric Neurology, Alberta Children's Hospital, Calgary, Alberta, Canada.""}, {'ForeName': 'Hugh J', 'Initials': 'HJ', 'LastName': 'McMillan', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': 'Department of Pediatrics, Epidemiology and Clinical Neurological Sciences, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Vid', 'Initials': 'V', 'LastName': 'Bijelić', 'Affiliation': 'CHEO Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Barrowman', 'Affiliation': 'CHEO Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Momoli', 'Affiliation': 'Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Henrietta', 'Initials': 'H', 'LastName': 'Blinder', 'Affiliation': 'CHEO Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Shawn D', 'Initials': 'SD', 'LastName': 'Aaron', 'Affiliation': 'Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'McAdam', 'Affiliation': 'Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'The Thanh Diem', 'Initials': 'TTD', 'LastName': 'Nguyen', 'Affiliation': 'Department of Respiratory Medicine, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tarnopolsky', 'Affiliation': 'Division of Neuromuscular and Neurometabolic Disease, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Wensley', 'Affiliation': ""Division of Pediatric Respirology, Department of Pediatrics, BC Children's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zielinski', 'Affiliation': ""Division of Pediatric Respirology, Department of Pediatrics, Montreal Children's Hospital, Montreal, Quebec, Canada.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Rose', 'Affiliation': ""Department of Midwifery and Palliative Care, King's College London Florence Nightingale School of Nursing and Midwifery, London, London, UK.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sheers', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Berlowitz', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Institute for Breathing and Sleep, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wolfe', 'Affiliation': 'Department of Medicine and Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'McKim', 'Affiliation': 'Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}]",Thorax,['10.1136/thoraxjnl-2021-218196']
3118,35236752,"Sentinel lymph node mapping versus sentinel lymph node mapping with systematic lymphadenectomy in endometrial cancer: an open-label, non-inferiority, randomized trial (ALICE trial).","BACKGROUND


Growing evidence suggest that sentinel lymph node (SLN) biopsy in endometrial cancer accurately detects lymph node metastasis. However, prospective randomized trials addressing the oncological outcomes of SLN biopsy in endometrial cancer without lymphadenectomy are lacking.
PRIMARY OBJECTIVES


The present study aims to confirm that SLN biopsy without systematic node dissection does not negatively impact oncological outcomes.
STUDY HYPOTHESIS


We hypothesized that there is no survival benefit in adding systematic lymphadenectomy to sentinel node mapping for endometrial cancer staging. Additionally, we aim to evaluate morbidity and impact in quality of life (QoL) after forgoing systematic lymphadenectomy.
TRIAL DESIGN


This is a collaborative, multicenter, open-label, non-inferiority, randomized trial. After total hysterectomy, bilateral salpingo-oophorectomy and SLN biopsy, patients will be randomized (1:1) into: (a) no further lymph node dissection or (b) systematic pelvic and para-aortic lymphadenectomy.
MAJOR INCLUSION AND EXCLUSION CRITERIA


Inclusion criteria are patients with high-grade histologies (endometrioid G3, serous, clear cell, and carcinosarcoma), endometrioid G1 or G2 with imaging concerning for myometrial invasion of ≥50% or cervical invasion, clinically suitable to undergo systematic lymphadenectomy.
PRIMARY ENDPOINTS


The primary objective is to compare 3-year disease-free survival and the secondary objectives are 5-year overall survival, morbidity, incidence of lower limb lymphedema, and QoL after SLN mapping ± systematic lymphadenectomy in high-intermediate and high-risk endometrial cancer.
SAMPLE SIZE


178 participants will be randomized in this study with an estimated date for completing accrual of December 2024 and presenting results in 2027.
TRIAL REGISTRATION NUMBER


NCT03366051.",2022,"Additionally, we aim to evaluate morbidity and impact in quality of life (QoL) after forgoing systematic lymphadenectomy.
","['endometrial cancer', '178 participants will be randomized in this study with an estimated date for completing accrual of December 2024 and presenting results in 2027', 'patients with high-grade histologies (endometrioid G3, serous, clear cell, and carcinosarcoma), endometrioid G1 or G2 with imaging concerning for myometrial invasion of ≥50%\u2009or cervical invasion, clinically suitable to undergo systematic lymphadenectomy']","['SLN biopsy without systematic node dissection', 'SLN biopsy', 'Sentinel lymph node mapping versus sentinel lymph node mapping with systematic lymphadenectomy', 'total hysterectomy, bilateral salpingo-oophorectomy and SLN biopsy', 'lymph node dissection or (b) systematic pelvic and para-aortic lymphadenectomy', 'sentinel lymph node (SLN) biopsy']","['3-year disease-free survival', 'quality of life (QoL', '5-year overall survival, morbidity, incidence of lower limb lymphedema, and QoL']","[{'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius'}, {'cui': 'C0007140', 'cui_str': 'Carcinosarcoma'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}]","[{'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C1519247', 'cui_str': 'Sentinel lymph node mapping'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0677962', 'cui_str': 'Total hysterectomy'}, {'cui': 'C0195495', 'cui_str': 'Bilateral salpingectomy with oophorectomy'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0442134', 'cui_str': 'Para-aortic'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}]",178.0,0.247955,"Additionally, we aim to evaluate morbidity and impact in quality of life (QoL) after forgoing systematic lymphadenectomy.
","[{'ForeName': 'Glauco', 'Initials': 'G', 'LastName': 'Baiocchi', 'Affiliation': 'Gynecologic Oncology, AC Camargo Cancer Center, São Paulo, Brazil glauco.baiocchi@accamargo.org.br.'}, {'ForeName': 'Carlos Eduardo Mattos Cunha', 'Initials': 'CEMC', 'LastName': 'Andrade', 'Affiliation': 'Gynecology Oncology, Barretos Cancer Hospital, Barretos, Brazil.'}, {'ForeName': 'Reitan', 'Initials': 'R', 'LastName': 'Ribeiro', 'Affiliation': 'Gynecologic Oncology, Erasto Gaertner Hospital, Curitiba, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Moretti-Marques', 'Affiliation': 'Gynecologic Oncology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Audrey Tieko', 'Initials': 'AT', 'LastName': 'Tsunoda', 'Affiliation': 'Gynecologic Oncology, Erasto Gaertner Hospital, Curitiba, Brazil.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Alvarenga-Bezerra', 'Affiliation': 'Gynecologic Oncology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Lopes', 'Affiliation': 'Gynecology, São Camilo Oncologia, São Paulo, Brazil.'}, {'ForeName': 'Ronaldo Lúcio Rangel', 'Initials': 'RLR', 'LastName': 'Costa', 'Affiliation': 'Gynecology, São Camilo Oncologia, São Paulo, Brazil.'}, {'ForeName': 'Lillian Yuri', 'Initials': 'LY', 'LastName': 'Kumagai', 'Affiliation': 'Gynecologic Oncology, AC Camargo Cancer Center, São Paulo, Brazil.'}, {'ForeName': 'Levon', 'Initials': 'L', 'LastName': 'Badiglian-Filho', 'Affiliation': 'Gynecologic Oncology, AC Camargo Cancer Center, São Paulo, Brazil.'}, {'ForeName': 'Carlos Chaves', 'Initials': 'CC', 'LastName': 'Faloppa', 'Affiliation': 'Gynecologic Oncology, AC Camargo Cancer Center, São Paulo, Brazil.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'Mantoan', 'Affiliation': 'Gynecologic Oncology, AC Camargo Cancer Center, São Paulo, Brazil.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'De Brot', 'Affiliation': 'Pathology, AC Camargo Cancer Center, São Paulo, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Dos Reis', 'Affiliation': 'Gynecology Oncology, Barretos Cancer Hospital, Barretos, Brazil.'}, {'ForeName': 'Bruna Tirapelli', 'Initials': 'BT', 'LastName': 'Goncalves', 'Affiliation': 'Gynecologic Oncology, AC Camargo Cancer Center, São Paulo, Brazil.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2022-003378']
3119,35237362,Layperson's performance on an unconversant type of AED device: A prospective crossover simulation experimental study.,"BACKGROUND


Diverse models of automated external defibrillators (AEDs) possess distinctive features. This study aimed to investigate whether laypersons trained with one type of AED could intelligently use another initial contact type of AED with varying features.
METHODS


This was a prospective crossover simulation experimental study conducted among college students. Subjects were randomly trained with either AED1 (AED1 group) or AED2 (AED2 group), and the AED operation performance was evaluated individually (Phase I test). At the 6-month follow-up AED performance test (Phase II test), half of the subjects were randomly switched to use another type of AED, which formed two switches (Switch A: AED1-1 group vs. AED2-1 group; Switch B: AED2-2 group vs. AED1-2 group).
RESULTS


A total of 224 college students participated in the study. In the phase I test, a significantly higher proportion of successful defibrillation and shorter shock delivery time to achieve successful defibrillation was observed in the AED2 group than in the AED1 group. In the phase II test, no statistical differences were observed in the proportion of successful defibrillation in Switch A (51.4% vs. 36.6%,  P =0.19) and Switch B (78.0% vs. 53.7%,  P =0.08). The median shock delivery time within participants achieving successful defibrillation was significantly longer in the switched group than that of the initial group in both Switch A (89 [81-107] s vs. 124 [95-135] s,  P =0.006) and Switch B (68 [61.5-81.5] s vs. 95.5 [55-131] s,  P <0.001).
CONCLUSION


College students were able to effectively use AEDs different from those used in the initial training after six months, although the time to shock delivery was prolonged.",2022,"In the phase II test, no statistical differences were observed in the proportion of successful defibrillation in Switch A (51.4% vs. 36.6%,  P =0.19) and Switch B (78.0% vs. 53.7%,  P =0.08).","['224 college students participated in the study', 'college students', 'College students']","['automated external defibrillators (AEDs', 'AED1 (AED1 group) or AED2 (AED2', 'AED1-1 group vs. AED2-1 group; Switch B: AED2-2 group vs. AED1-2 group']","['proportion of successful defibrillation', 'successful defibrillation and shorter shock delivery time to achieve successful defibrillation', 'median shock delivery time', 'successful defibrillation']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C1301668', 'cui_str': 'Time of delivery'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",224.0,0.0137249,"In the phase II test, no statistical differences were observed in the proportion of successful defibrillation in Switch A (51.4% vs. 36.6%,  P =0.19) and Switch B (78.0% vs. 53.7%,  P =0.08).","[{'ForeName': 'Chao-Yu', 'Initials': 'CY', 'LastName': 'Lei', 'Affiliation': 'Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.'}, {'ForeName': 'Heng-Wei', 'Initials': 'HW', 'LastName': 'Qin', 'Affiliation': 'Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.'}, {'ForeName': 'Xue-Jie', 'Initials': 'XJ', 'LastName': 'Dong', 'Affiliation': 'Department of Global Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Jia-Lin', 'Initials': 'JL', 'LastName': 'You', 'Affiliation': 'Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.'}]",World journal of emergency medicine,['10.5847/wjem.j.1920-8642.2022.024']
3120,35237342,Effects of Low-Dose Aspirin Combined with Vitamin E on the Incidence of Intrauterine Growth Restriction and Hemorheological Indexes of Pregnant Women in Patients with Gestational Hypertension.,"Objective


To investigate the effect of low-dose aspirin combined with vitamin E on the incidence of intrauterine growth restriction and hemorheological indexes of pregnant women in patients with gestational hypertension.
Method


134 elderly patients with chronic urticaria treated in our hospital from November 2017 to November 2020 were studied. According to the treatment methods, they were randomly divided into observation and control groups. There were 67 patients in the observation group, aged 20-37 years, with an average of (25.7 ± 2.75) years. There were 67 patients in the control group, aged 21-35 years, with an average of (26.3 ± 3.17) years. No significant difference was observed between the two groups ( P  > 0.05).
Results


The number of cases with postpartum hemorrhage and intrauterine growth restriction in the observation group was less than that in the control group. The total incidence rate was lower than that in the control group. There were significant differences in the above results ( P  < 0.05). The number of patients with preterm birth in the observation group was less than that in the control group, but there was no significant difference in the results ( P  > 0.05). The head circumference, abdominal circumference, biparietal diameter, and femoral length diameter in the control and observation groups increased significantly after treatment ( P  < 0.05). Compared with the control group, the head circumference, abdominal circumference, biparietal diameter, and femoral diameter in the observation group increased more after treatment, and the results were statistically poor ( P  < 0.05). The systolic blood pressure, diastolic blood pressure, and mean arterial pressure in the control and observation groups decreased significantly after treatment, and the results were statistically different ( P  < 0.05). Compared with the control group, the systolic blood pressure, diastolic blood pressure, and mean arterial pressure in the observation group decreased more after treatment. The results were statistically different ( P  < 0.05). The plasma viscosity levels, whole blood high shear viscosity, and whole blood low shear viscosity in the control and observation groups decreased significantly after treatment, and the results were statistically different ( P  < 0.05). Compared with the control group, plasma viscosity levels, whole blood high shear viscosity, and whole blood low shear viscosity in the observation group decreased more after treatment, and the results were statistically different ( P  < 0.05). The control and observation groups' fetal systolic/diastolic pressure and pulsatile index decreased significantly after treatment, and the results were statistically different ( P  < 0.05). Compared with the control group, the fetal systolic/diastolic blood pressure and pulsatile index in the observation group decreased more after treatment, and the results were statistically poor ( P  < 0.05).
Conclusion


Low-dose aspirin combined with vitamin E is effective in treating intrauterine growth restriction in patients with gestational hypertension. It can effectively control the blood pressure and blood flow of patients and newborns and improve pregnancy outcomes without increasing the incidence of adverse reactions. It is worthy of clinical promotion.",2022,"The systolic blood pressure, diastolic blood pressure, and mean arterial pressure in the control and observation groups decreased significantly after treatment, and the results were statistically different ( P  < 0.05).","['134 elderly patients with chronic urticaria treated in our hospital from November 2017 to November 2020 were studied', '67 patients in the observation group, aged 20-37 years, with an average of (25.7 ± 2.75) years', 'patients with gestational hypertension', 'Pregnant Women in Patients with Gestational Hypertension', '67 patients in the control group, aged 21-35 years, with an average of (26.3 ± 3.17) years', 'pregnant women in patients with gestational hypertension']","['Low-Dose Aspirin Combined with Vitamin E', 'low-dose aspirin combined with vitamin E', 'aspirin combined with vitamin E']","['intrauterine growth restriction and hemorheological indexes', 'head circumference, abdominal circumference, biparietal diameter, and femoral length diameter', 'plasma viscosity levels, whole blood high shear viscosity, and whole blood low shear viscosity', 'fetal systolic/diastolic blood pressure and pulsatile index', 'total incidence rate', 'head circumference, abdominal circumference, biparietal diameter, and femoral diameter', 'fetal systolic/diastolic pressure and pulsatile index', 'Intrauterine Growth Restriction and Hemorheological Indexes', 'blood pressure and blood flow', 'number of cases with postpartum hemorrhage and intrauterine growth restriction', 'systolic blood pressure, diastolic blood pressure, and mean arterial pressure', 'number of patients with preterm birth']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263338', 'cui_str': 'Chronic urticaria'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517639', 'cui_str': '2.75'}, {'cui': 'C0341934', 'cui_str': 'Transient hypertension of pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C4517686', 'cui_str': '3.17'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}]","[{'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0552399', 'cui_str': 'Biparietal diameter'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0427685', 'cui_str': 'Plasma viscosity measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439606', 'cui_str': 'Pulsatile'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",134.0,0.0154995,"The systolic blood pressure, diastolic blood pressure, and mean arterial pressure in the control and observation groups decreased significantly after treatment, and the results were statistically different ( P  < 0.05).","[{'ForeName': 'Tengfei', 'Initials': 'T', 'LastName': 'Shan', 'Affiliation': ""First People's Hospital of Linping District, Hangzhou 311100, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""First People's Hospital of Linping District, Hangzhou 311100, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': ""First People's Hospital of Linping District, Hangzhou 311100, China.""}]",Computational and mathematical methods in medicine,['10.1155/2022/6328807']
3121,35237340,Analysis of Clinical Efficacy of Clearing Heat and Dispelling Paralysis Soup in the Treatment of Osteoarthritis of the Knee Joint and Its Effect on Patients' Motor Function.,"Objective


To investigate the effects of clearing heat and dispelling paralysis soup for osteoarthritis of the knee joint on the motor function of the knee joint and the level of inflammation of the organism in patients.
Methods


One hundred and sixteen patients with knee osteoarthritis admitted from January 2020 to May 2021 were selected and randomly divided into 2 groups, 58 cases in the control group were treated with loxoprofen sodium dispersible tablets, and 58 cases in the experimental group were treated with Qinghe dispel paralysis soup on the basis of the control group and the patients' balance ability analysis, gait parameter change analysis, VAS, JOA, AIMS2-SF scale assessment, and serum index. The treatment effects of the two treatment regimens were analyzed by testing.
Results


The anterior-posterior axis, left-right axis, A2-A6, A4-A8, and circumferential axis of the experimental group were lower than those of the control group after treatment ( P  < 0.05); the step length of the experimental group was higher than that of the control group after treatment ( P  < 0.05), and there were no significant differences in step speed, double-support phase, and step width ( P  > 0.05), but both groups improved significantly compared with those before treatment ( P  < 0.05); the VAS score of the experimental group was lower than that of the control group after treatment. The VAS scores of the experimental group were lower than those of the control group, and the scores of JOA and AIMS2-SF were higher than those of the control group ( P  < 0.05); the levels of TIMP-1 in the experimental group were higher than those in the control group, and the levels of TNF- α , TLR4, MMP-3, and IL-1 were lower than those in the control group after treatment ( P  < 0.05); there was no significant difference in the incidence of adverse reactions between the two groups during treatment ( P  > 0.05), and the efficiency of the experimental group was higher than that of the control group ( P  < 0.05).
Conclusion


Combined treatment with Qinghe dispel paralysis soup can better promote the recovery of balance, improve motor ability, and reduce the development of inflammation in the organism, with high safety and effectiveness.",2022,"The VAS scores of the experimental group were lower than those of the control group, and the scores of JOA and AIMS2-SF were higher than those of the control group ( P  < 0.05); the levels of TIMP-1 in the experimental group were higher than those in the control group, and the levels of TNF- α , TLR4, MMP-3, and IL-1 were lower than those in the control group after treatment ( P  < 0.05); there was no significant difference in the incidence of adverse reactions between the two groups during treatment ( P  > 0.05), and the efficiency of the experimental group was higher than that of the control group ( P  < 0.05).
","['patients', ""Patients' Motor Function"", 'Methods\n\n\nOne hundred and sixteen patients with knee osteoarthritis admitted from January 2020 to May 2021']","['Clearing Heat and Dispelling Paralysis Soup', 'loxoprofen sodium dispersible tablets', 'clearing heat and dispelling paralysis soup']","['levels of TIMP-1', 'VAS score', 'incidence of adverse reactions', 'step speed, double-support phase, and step width', 'scores of JOA and AIMS2-SF', 'levels of TNF- α , TLR4, MMP-3, and IL-1', 'balance ability analysis, gait parameter change analysis, VAS, JOA, AIMS2-SF scale assessment, and serum index', 'VAS scores', 'anterior-posterior axis, left-right axis, A2-A6, A4-A8, and circumferential axis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0237766', 'cui_str': 'Hysterical paralysis'}, {'cui': 'C0453399', 'cui_str': 'Soup'}, {'cui': 'C0065199', 'cui_str': 'loxoprofen'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0991504', 'cui_str': 'Disintegrating Oral Tablet'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0145947', 'cui_str': 'Tissue inhibitor of metalloproteinases 1'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}]",116.0,0.0198846,"The VAS scores of the experimental group were lower than those of the control group, and the scores of JOA and AIMS2-SF were higher than those of the control group ( P  < 0.05); the levels of TIMP-1 in the experimental group were higher than those in the control group, and the levels of TNF- α , TLR4, MMP-3, and IL-1 were lower than those in the control group after treatment ( P  < 0.05); there was no significant difference in the incidence of adverse reactions between the two groups during treatment ( P  > 0.05), and the efficiency of the experimental group was higher than that of the control group ( P  < 0.05).
","[{'ForeName': 'Lihu', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'The First Affiliated Hospital, Department of Rheumatology and Immunology, Hengyang Medical College, University of South China, Hengyang Hunan 421001, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital, Department of Rheumatology and Immunology, Hengyang Medical College, University of South China, Hengyang Hunan 421001, China.'}]",Computational and mathematical methods in medicine,['10.1155/2022/5104121']
3122,35237336,Restoration Algorithm-Based Ultrasound Image in Evaluating the Effect of Dexmedetomidine on Patients with Neurological Disorder Anesthetized by Sevoflurane.,"The study focused on the application value of ultrasound images processed by restoration algorithm in evaluating the effect of dexmedetomidine in preventing neurological disorder in patients undergoing sevoflurane anesthesia. 90 patients undergoing tonsillectomy anesthesia were randomly divided into normal saline group, propofol group, and dexmedetomidine group. The ultrasound images were processed by restoration algorithm, and during the postoperative recovery period, ultrasound images were used to evaluate. The results showed that the original ultrasonic image was fuzzy and contained interference noise, and that the image optimized by restoration algorithm was clear, without excess noise, and the image quality was significantly improved. In the dexmedetomidine group, the extubation time was 10.6 ± 2.3 minutes, the recovery time was 8.4 ± 2.2 minutes, the average pain score during the recovery period was 2.6 ± 0.7, and the average agitation score was 7.2 ± 2.4. Of 30 patients, there were 13 cases with vertigo and 1 case with nausea and vomiting. The vascular ultrasound imaging showed that, in the dexmedetomidine group, the peak systolic velocities (PSV) of the bilateral vertebral arteries during the recovery period were 67.7 ± 14.3 and 67.9 ± 15.2 cm/s, respectively; the end-diastolic velocities (EDV) of the bilateral vertebral arteries were 27.8 ± 6.7 and 24.69 ± 5.9 cm/s, respectively; the PSV in bilateral internal carotid artery systolic peak velocities were 67.2 ± 13.9 and 67.8 ± 12.7 cm/s, respectively; the EDV in bilateral internal carotid arteries were 27.7 ± 5.3 and 26.9 ± 4.9 cm/s, respectively; bilateral vertebral artery resistance indexes (RIs) were 0.6 ± 0.02 and 0.71 ± 0.08, respectively; the bilateral internal carotid artery RIs were 0.57 ± 0.04 and 0.58 ± 0.06, respectively, all better than the normal saline group (12.1 ± 2.5 minutes, 10.1 ± 2.3 minutes, 3.9 ± 0.6, 10.6 ± 3.7, 15 cases, 11 cases, 81.5 ± 13.6, 80.7 ± 11.6 cm/s, 29.3 ± 6.8, 28.9 ± 6.7 cm/s, 74.3 ± 10.2, 73.9 ± 12.5 cm/s, 29.1 ± 4.3, 29 ± 4.5 cm/s, 0.84 ± 0.06, 0.83 ± 0.05, 0.8 ± 0.04, and 0.81 ± 0.05) and the propofol group (11.4 ± 2.1 minutes, 9.0 ± 2.1 minutes, 3.4 ± 0.8, 8.5 ± 2.3, 12 cases, 9 cases, 72.5 ± 12.9, 73.4 ± 11.8 cm/s, 28.6 ± 5.4, 26.5 ± 5.1 cm/s, 72.1 ± 11.4, 73.5 ± 10.6 cm/s, 28.8 ± 5.6, 27.3 ± 4.7 cm/s, 0.78 ± 0.07, 0.82 ± 0.06, 0.76 ± 0.03, and 0.78 ± 0.05), and the differences were statistically significant ( P  < 0.05). In conclusion, ultrasound images processed by restoration algorithm have high image quality and high resolution. The dexmedetomidine can prevent neurological disorder in patients with sevoflurane anesthesia and is suggested in postoperative rehabilitation.",2022,"The results showed that the original ultrasonic image was fuzzy and contained interference noise, and that the image optimized by restoration algorithm was clear, without excess noise, and the image quality was significantly improved.","['30 patients, there were 13 cases with vertigo and 1 case with', 'patients undergoing sevoflurane anesthesia', 'Patients with Neurological Disorder', 'patients with', '90 patients undergoing tonsillectomy anesthesia']","['Sevoflurane', 'normal saline group, propofol', 'dexmedetomidine', 'sevoflurane anesthesia', 'Dexmedetomidine']","['bilateral vertebral artery resistance indexes', 'recovery time', 'average pain score', 'average agitation score', 'nausea and vomiting', 'image quality', 'extubation time', 'bilateral internal carotid artery RIs', 'neurological disorder', 'end-diastolic velocities (EDV) of the bilateral vertebral arteries', 'bilateral internal carotid artery systolic peak velocities', 'peak systolic velocities (PSV) of the bilateral vertebral arteries']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444864', 'cui_str': 'AM 13'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0042559', 'cui_str': 'Structure of vertebral artery'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic'}]",90.0,0.0499152,"The results showed that the original ultrasonic image was fuzzy and contained interference noise, and that the image optimized by restoration algorithm was clear, without excess noise, and the image quality was significantly improved.","[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ""Department of Anesthesiology, The First People's Hospital of Xuzhou, Xuzhou, 221000 Jiangsu, China.""}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, People's Hospital of Xuyi County, Xuyi, 211700 Jiangsu, China.""}, {'ForeName': 'Yanming', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Anesthesiology, People's Hospital of Xuyi County, Xuyi, 211700 Jiangsu, China.""}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, People's Hospital of Xuyi County, Xuyi, 211700 Jiangsu, China.""}, {'ForeName': 'Daolin', 'Initials': 'D', 'LastName': 'Xia', 'Affiliation': ""Department of Anesthesiology, People's Hospital of Xuyi County, Xuyi, 211700 Jiangsu, China.""}]",Computational and mathematical methods in medicine,['10.1155/2022/1320893']
3123,35239547,"Pain response to cannabidiol in opioid-induced hyperalgesia, acute nociceptive pain, and allodynia using a model mimicking acute pain in healthy adults in a randomized trial (CANAB II).","ABSTRACT


Opioids in general and remifentanil in particular can induce hyperalgesia. Preclinical data suggest that cannabidiol might have the capacity to reduce opioid-induced hyperalgesia (OIH). Thus, we investigated the effect of oral cannabidiol on OIH in healthy volunteers using an established pain model. Twenty-four healthy participants were included in this randomized, double-blinded, crossover study and received either a 1600-mg single-dose oral cannabidiol or placebo. Hyperalgesia, allodynia, and pain were induced by intracutaneous electrical stimulation. To provoke OIH, participants recieved an infusion of 0.1 µg/kg/min remifentanil over a time frame of 30 minutes, starting 100 minutes after oral cannabidiol ingestion. The primary outcome was the area of hyperalgesia (in square centimetres) up to 60 minutes after remifentanil administration. The area of allodynia (in square centimetres) and pain (numeric rating scale) were also assessed.Cannabidiol had no significant effect on hyperalgesia, allodynia, or pain at any time point of measurement compared with placebo. The area of hyperalgesia after remifentanil administration significantly increased compared with baseline (17.0 cm2 [8.1-28.7] vs 25.3 cm2 [15.1-39.6]; P = 0.013). Mean cannabidiol blood levels were 4.1 ± 3.0 µg/L (mean ± SD) at 130 minutes after ingestion and were 8.2 μg/L ± 6.9 µg/L (mean ± SD) at 200 minutes. Cannabidiol was well tolerated. We conclude that a high single-oral dose of 1600-mg cannabidiol is not effective in reducing OIH. Before excluding an effect of cannabidiol on OIH, research should focus on drug formulations enabling higher cannabidiol concentrations.",2022,"Cannabidiol had no significant effect on hyperalgesia, allodynia, or pain at any time point of measurement compared with placebo.","['Twenty-four healthy participants', 'healthy adults', 'healthy volunteers using an established pain model']","['remifentanil', 'oral cannabidiol', '1600-mg single-dose oral cannabidiol or placebo', 'placebo']","['hyperalgesia, allodynia, or pain', 'tolerated', 'Hyperalgesia, allodynia, and pain', 'Mean cannabidiol blood levels', 'area of hyperalgesia', 'area of allodynia (in square centimetres) and pain (numeric rating scale', 'Pain response']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439479', 'cui_str': 'sq. cm'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}]",24.0,0.22176,"Cannabidiol had no significant effect on hyperalgesia, allodynia, or pain at any time point of measurement compared with placebo.","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Dieterle', 'Affiliation': 'Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital of Basel, Basel, Switzerland Institute of Forensic Medicine, Department of Biomedical Engineering, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zurbriggen', 'Affiliation': ''}, {'ForeName': 'Eckhard', 'Initials': 'E', 'LastName': 'Mauermann', 'Affiliation': ''}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Mercer-Chalmers-Bender', 'Affiliation': ''}, {'ForeName': 'Priska', 'Initials': 'P', 'LastName': 'Frei', 'Affiliation': ''}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Ruppen', 'Affiliation': ''}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schneider', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000002591']
3124,35239526,Transanal Hemorrhoidal Dearterialization with Mucopexy vs Vessel Sealing Device Hemorrhoidectomy for Grade III-IV Hemorrhoids: Long-term Outcomes from the THDLIGA-RCT Randomized Clinical Trial.,"BACKGROUND


Both transanal hemorrhoidal dearterialization and vessel sealing device hemorrhoidectomy are safe and well tolerated for grade III-IV hemorrhoid treatment. The first is associated with a shorter need of postoperative analgesia than vessel sealing device hemorrhoidectomy. Whether one of them is superior regarding long-term results remains unclear.
OBJECTIVE


The objective was to compare long-term results after transanal hemorrhoidal dearterialization and vessel sealing device hemorrhoidectomy.
DESIGN


A multicenter randomized clinical trial was conducted.
SETTING


This study was conducted at 6 centers.
PATIENTS


Patients aged ≥18 years with grade III-IV hemorrhoids were included in the study.
INTERVENTIONS


Patients were randomly assigned to transanal hemorrhoidal dearterialization (n=39) or vessel sealing device hemorrhoidectomy (n = 41).
MAIN OUTCOME MEASURES


The primary outcome was hemorrhoid symptom recurrence assessed by a specific questionnaire 2 years postoperatively. Secondary outcomes included long-term complications, reoperations, fecal continence, patient's satisfaction, and quality of life.
RESULTS


Five of the 80 patients included in the study were lost to follow-up. Thirty-six patients randomized to transanal hemorrhoidal dearterialization and 39 randomized to vessel sealing device hemorrhoidectomy were included in the long-term analysis. The differences between mean baseline and mean 2-year score in the two groups were similar (-11.0, SD 3.8 vs -12.5, SD 3.6; p = 0.080). Three patients in the transanal hemorrhoidal dearterialization group underwent supplementary procedures for hemorrhoid symptoms, compared with none in the vessel sealing device hemorrhoidectomy group (p = 0.106). Four patients in the vessel sealing hemorrhoidectomy group and none in the transanal hemorrhoidal dearterialization group experienced chronic opened wound (p = 0.116). No differences were found in terms fecal continence (p = 0.657), patient's satisfaction (p = 0.483) and quality of life.
LIMITATIONS


No stratification for hemorrhoid grade and power calculation based on the main outcome trial but not on the end-point of this long-term study.
CONCLUSIONS


Transanal hemorrhoidal dearterialization with mucopexy is associated with similar hemorrhoid symptom recurrence than vessel sealing device hemorrhoidectomy at two years. See Video Abstract at http://links.lww.com/DCR/B933.
TRIAL REGISTRATION


clinicaltrials.gov (NCT02654249).",2022,"No differences were found in terms fecal continence (p = 0.657), patient's satisfaction (p = 0.483) and quality of life.
","['Five of the 80 patients included in the study were lost to follow-up', 'Grade III-IV Hemorrhoids', 'This study was conducted at 6 centers', 'Patients aged ≥18 years with grade III-IV hemorrhoids were included in the study']","['transanal hemorrhoidal dearterialization', 'vessel sealing device hemorrhoidectomy', 'vessel sealing hemorrhoidectomy', 'Transanal Hemorrhoidal Dearterialization with Mucopexy vs Vessel Sealing Device Hemorrhoidectomy', 'transanal hemorrhoidal dearterialization and vessel sealing device hemorrhoidectomy', 'transanal hemorrhoidal dearterialization (n=39) or vessel sealing device hemorrhoidectomy']","['fecal continence', ""patient's satisfaction"", 'quality of life', 'chronic opened wound', 'mean baseline and mean 2-year score', 'hemorrhoid symptom recurrence assessed by a specific questionnaire 2 years postoperatively', ""long-term complications, reoperations, fecal continence, patient's satisfaction, and quality of life""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}]","[{'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332798', 'cui_str': 'Open wound'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C4524105', 'cui_str': 'Symptom recurrence'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]",36.0,0.160824,"No differences were found in terms fecal continence (p = 0.657), patient's satisfaction (p = 0.483) and quality of life.
","[{'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Trenti', 'Affiliation': ""Department of General and Digestive Surgery - Colorectal Unit, Bellvitge University Hospital, University of Barcelona and IDIBELL, Barcelona, Spain Department of General and Digestive Surgery - Colorectal Unit. Vall d'Hebron University Hospital Barcelona, Spain Department of Surgery, Galdakao Usansolo Hospital, Vizcaya, Spain Department of Surgery, La Princesa University Hospital, Madrid, Spain Department of Surgery, Valdeorras Hospital, Ourense, Spain Department of Surgery, Rey Juan Carlos University Hospital, Móstoles, Madrid, Spain.""}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Biondo', 'Affiliation': ''}, {'ForeName': 'Eloy', 'Initials': 'E', 'LastName': 'Espin-Basany', 'Affiliation': ''}, {'ForeName': 'Oriana', 'Initials': 'O', 'LastName': 'Barrios', 'Affiliation': ''}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Sanchez', 'Affiliation': ''}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Landaluce', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bermejo', 'Affiliation': ''}, {'ForeName': 'Maite T', 'Initials': 'MT', 'LastName': 'Garcia-Martinez', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Alias', 'Affiliation': ''}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Jimenez', 'Affiliation': ''}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Alonso', 'Affiliation': ''}, {'ForeName': 'Maria B', 'Initials': 'MB', 'LastName': 'Manso', 'Affiliation': ''}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kreisler', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000002272']
3125,35239511,Microbiota dynamics in a randomized trial of gut decontamination during allogeneic hematopoietic cell transplantation.,"BACKGROUND


Gut decontamination (GD) can decrease the incidence and severity of acute graft-versus-host-disease (aGVHD) in murine models of allogeneic hematopoietic cell transplantation (HCT). In this pilot study, we examined the impact of GD on the gut microbiome composition and incidence of aGVHD in HCT patients.
METHODS


We randomized 20 pediatric patients undergoing allogeneic HCT to receive (GD) or not receive (no-GD) oral vancomycin-polymyxin B from day -5 through neutrophil engraftment. We evaluated shotgun metagenomic sequencing of serial stool samples to compare the composition and diversity of the gut microbiome between study arms. We assessed clinical outcomes in the 2 arms and performed strain-specific analyses of pathogens that caused bloodstream infections (BSI).
RESULTS


The two arms did not differ in the predefined primary outcome of Shannon diversity of the gut microbiome at two weeks post-HCT (Genus, p=0.8; Species, p=0.44) or aGVHD incidence (p=0.58). Immune reconstitution of T-cell and B-cell subsets was similar between groups. Five patients in the no-GD arm had eight BSI episodes vs one episode in the GD arm (p=0.09). The BSI-causing pathogens were traceable to the gut in seven of eight BSI episodes in the no-GD arm, including Staphylococcus species.
CONCLUSIONS


While GD did not differentially impact Shannon diversity or clinical outcomes, our findings suggest that GD may protect against gut-derived BSI in HCT patients by decreasing the prevalence or abundance of gut pathogens.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02641236FUNDING. NIH, Damon Runyon Cancer Research Foundation, V Foundation, Sloan Foundation, Emerson Collective, Stanford MCHRI.",2022,"CONCLUSIONS


While GD did not differentially impact Shannon diversity or clinical outcomes","['allogeneic hematopoietic cell transplantation', '20 pediatric patients undergoing', 'HCT patients']","['allogeneic HCT to receive (GD) or not receive (no-GD) oral vancomycin-polymyxin B', 'Gut decontamination (GD', 'allogeneic hematopoietic cell transplantation (HCT']","['eight BSI episodes', 'Immune reconstitution of T-cell and B-cell subsets', 'Shannon diversity of the gut microbiome']","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C0360373', 'cui_str': 'Vancomycin-containing product in oral dose form'}, {'cui': 'C0032535', 'cui_str': 'Polymyxin B'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C4505207', 'cui_str': 'Immune Regeneration'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0079004', 'cui_str': 'B-Cell Subsets'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",20.0,0.207395,"CONCLUSIONS


While GD did not differentially impact Shannon diversity or clinical outcomes","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Severyn', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Stanford, United States of America.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Siranosian', 'Affiliation': 'Department of Genetics and Medicine, Stanford University School of Medicine, Stanford, United States of America.'}, {'ForeName': 'Sandra Tian-Jiao', 'Initials': 'ST', 'LastName': 'Kong', 'Affiliation': 'Department of Biology and Biomedical Informatics, Stanford University School of Medicine, Stanford, United States of America.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Moreno', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Palo Alto, United States of America.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Li', 'Affiliation': 'Department of Biomedical Informatics, Harvard Medical School, Boston, United States of America.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': ""Dana-Farber/Boston Children's Cancer & Blood Disorders Center, Dana-Farber/Boston Children's Cancer & Blood Disorders Center, Boston, United States of America.""}, {'ForeName': 'Christine N', 'Initials': 'CN', 'LastName': 'Duncan', 'Affiliation': ""Dana-Farber/Boston Children's Cancer & Blood Disorders Center, Dana-Farber/Boston Children's Cancer & Blood Disorders Center, Boston, United States of America.""}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Margossian', 'Affiliation': ""Dana-Farber/Boston Children's Cancer & Blood Disorders Center, Dana-Farber/Boston Children's Cancer & Blood Disorders Center, Boston, United States of America.""}, {'ForeName': 'Leslie E', 'Initials': 'LE', 'LastName': 'Lehmann', 'Affiliation': ""Dana-Farber/Boston Children's Cancer & Blood Disorders Center, Dana-Farber/Boston Children's Cancer & Blood Disorders Center, Boston, United States of America.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Bioinformatics and Genomics, UNC Charlotte, Charlotte, United States of America.'}, {'ForeName': 'Tessa M', 'Initials': 'TM', 'LastName': 'Andermann', 'Affiliation': 'Department of Medicine, UNC Chapel Hill, Chapel Hill, United States of America.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Birbrayer', 'Affiliation': 'Dana-Farber Cancer Institute, Dana-Farber Cancer Institute, Boston, United States of America.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Silverstein', 'Affiliation': 'Dana-Farber Cancer Institute, Dana-Farber Cancer Institute, Boston, United States of America.'}, {'ForeName': 'Soomin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Dana-Farber Cancer Institute, Dana-Farber Cancer Institute, Boston, United States of America.'}, {'ForeName': 'Niaz', 'Initials': 'N', 'LastName': 'Banaei', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Palo Alto, United States of America.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Ritz', 'Affiliation': 'Dana-Farber Cancer Institute, Dana-Farber Cancer Institute, Boston, United States of America.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Fodor', 'Affiliation': 'UNC Charlotte, Charlotte, United States of America.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'London', 'Affiliation': ""Dana-Farber/Boston Children's Cancer & Blood Disorders Center, Dana-Farber/Boston Children's Cancer & Blood Disorders Center, Boston, United States of America.""}, {'ForeName': 'Ami S', 'Initials': 'AS', 'LastName': 'Bhatt', 'Affiliation': 'Department of Genetics and Medicine, Stanford University School of Medicine, Stanford, United States of America.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Whangbo', 'Affiliation': 'Dana-Farber Cancer Institute, Dana-Farber Cancer Institute, Boston, United States of America.'}]",JCI insight,['10.1172/jci.insight.154344']
3126,35239971,Dasiglucagon-A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia: Results of Phase 3 Randomized Double-Blind Clinical Trial.,"OBJECTIVE


To evaluate the efficacy and safety of dasiglucagon, a ready-to-use, next-generation glucagon analog in aqueous formulation for subcutaneous dosing, for treatment of severe hypoglycemia in adults with type 1 diabetes.
RESEARCH DESIGN AND METHODS


This randomized, double-blind trial included 170 adult participants with type 1 diabetes, each randomly assigned to receive a single subcutaneous dose of 0.6 mg dasiglucagon, placebo, or 1 mg reconstituted glucagon (2:1:1 randomization) during controlled insulin-induced hypoglycemia. The primary end point was time to plasma glucose recovery, defined as an increase of ≥20 mg/dL from baseline without rescue intravenous glucose. The primary comparison was dasiglucagon versus placebo; reconstituted lyophilized glucagon was included as reference.
RESULTS


Median (95% CI) time to recovery was 10 (10, 10) minutes for dasiglucagon compared with 40 (30, 40) minutes for placebo (P < 0.001); the corresponding result for reconstituted glucagon was 12 (10, 12) minutes. In the dasiglucagon group, plasma glucose recovery was achieved within 15 min in all but one participant (99%), superior to placebo (2%; P < 0.001) and similar to glucagon (95%). Similar outcomes were observed for the other investigated time points at 10, 20, and 30 min after dosing. The most frequent adverse effects were nausea and vomiting, as expected with glucagon treatment.
CONCLUSIONS


Dasiglucagon provided rapid and effective reversal of hypoglycemia in adults with type 1 diabetes, with safety and tolerability similar to those reported for reconstituted glucagon injection. The ready-to-use, aqueous formulation of dasiglucagon offers the potential to provide rapid and reliable treatment of severe hypoglycemia.",2021,"The ready-to-use, aqueous formulation of dasiglucagon offers the potential to provide rapid and reliable treatment of severe hypoglycemia.","['adults with type 1 diabetes', '170 adult participants with type 1 diabetes', 'Severe Hypoglycemia']","['single subcutaneous dose of 0.6 mg dasiglucagon, placebo, or 1 mg reconstituted glucagon', 'placebo', 'placebo; reconstituted lyophilized glucagon']","['severe hypoglycemia', 'plasma glucose recovery', 'time to plasma glucose recovery, defined as an increase of ≥20 mg/dL from baseline without rescue intravenous glucose', 'nausea and vomiting']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",170.0,0.590609,"The ready-to-use, aqueous formulation of dasiglucagon offers the potential to provide rapid and reliable treatment of severe hypoglycemia.","[{'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes and Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Hövelmann', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Willard', 'Affiliation': 'ProSciento, San Diego, CA.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil, Mainz, Germany.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Knudsen', 'Affiliation': 'Zealand Pharma, Søborg, Denmark.'}, {'ForeName': 'Benedikte', 'Initials': 'B', 'LastName': 'Bandak', 'Affiliation': 'Zealand Pharma, Søborg, Denmark.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tehranchi', 'Affiliation': 'Zealand Pharma, Søborg, Denmark.'}]",Diabetes care,['10.2337/dc20-2995']
3127,35239783,Effects of caffeine on central and peripheral fatigue following closed- and open-loop cycling exercises.,"We examined whether endurance performance and neuromuscular fatigue would be affected by caffeine ingestion during closed- and open-loop exercises. Nine cyclists performed a closed-loop (4,000-m cycling time trial) and an open-loop exercise (work rate fixed at mean power of the closed-loop trial) 60 min after ingesting caffeine (CAF, 5 mg/kg) or placebo (PLA, cellulose). Central and peripheral fatigue was quantified via pre- to post-exercise decrease in quadriceps voluntary activation and potentiated twitch force, respectively. Test sensitivity for detecting caffeine-induced improvements in exercise performance was calculated as the mean change in time divided by the error of measurement. Caffeine ingestion reduced the time of the closed-loop trial (PLA: 375.1±14.5 s vs CAF: 368.2±14.9 s, P=0.024) and increased exercise tolerance during the open-loop trial (PLA: 418.2±99.5 s vs CAF: 552.5±106.5 s, P=0.001), with similar calculated sensitivity indices (1.5, 90%CI: 0.7-2.9 vs 2.8, 90%CI: 1.9-5.1). The reduction in voluntary activation was more pronounced (P=0.019) in open- (-6.8±8.3%) than in closed-loop exercises (-1.9±4.4%), but there was no difference between open- and closed-loop exercises for the potentiated twitch force reduction (-25.6±12.8 vs -26.6±12.0%, P>0.05). Caffeine had no effect on central and peripheral fatigue development in either mode of exercise. In conclusion, caffeine improved endurance performance in both modes of exercise without influence on post-exercise central and peripheral fatigue, with the open-loop exercise imposing a greater challenge to central fatigue tolerance.",2022,"In conclusion, caffeine improved endurance performance in both modes of exercise without influence on post-exercise central and peripheral fatigue, with the open-loop exercise imposing a greater challenge to central fatigue tolerance.",[],"['caffeine', 'Caffeine ingestion', 'open-loop exercise (work rate fixed at mean power of the closed-loop trial) 60 min after ingesting caffeine (CAF, 5 mg/kg) or placebo (PLA, cellulose', 'CAF', 'Caffeine']","['quadriceps voluntary activation and potentiated twitch force', 'central and peripheral fatigue development', 'central fatigue tolerance', 'Central and peripheral fatigue', 'endurance performance', 'exercise tolerance', 'endurance performance and neuromuscular fatigue', 'exercise performance', 'reduction in voluntary activation', 'twitch force reduction', 'central and peripheral fatigue']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0559530', 'cui_str': 'Open loop'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",60.0,0.0355345,"In conclusion, caffeine improved endurance performance in both modes of exercise without influence on post-exercise central and peripheral fatigue, with the open-loop exercise imposing a greater challenge to central fatigue tolerance.","[{'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Couto', 'Affiliation': 'Grupo de Estudos em Desempenho Aeróbio da USP, Escola de Educação Física e Esportes, Universidade de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Silva-Cavalcante', 'Affiliation': 'Faculdade de Nutrição, Universidade Federal de Alagoas, Maceió, AL, Brasil.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mezêncio', 'Affiliation': 'Laboratório de Biomecânica, Escola de Educação Física e Esportes, Universidade de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Azevedo', 'Affiliation': 'Grupo de Estudos em Desempenho Aeróbio da USP, Escola de Educação Física e Esportes, Universidade de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cruz', 'Affiliation': 'Grupo de Estudos em Desempenho Aeróbio da USP, Escola de Educação Física e Esportes, Universidade de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bertuzzi', 'Affiliation': 'Grupo de Estudos em Desempenho Aeróbio da USP, Escola de Educação Física e Esportes, Universidade de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Lima-Silva', 'Affiliation': 'Grupo de Pesquisa em Performance Humana, Universidade Tecnológica Federal do Paraná, Curitiba, PR, Brasil.'}, {'ForeName': 'M A P D', 'Initials': 'MAPD', 'LastName': 'Kiss', 'Affiliation': 'Grupo de Estudos em Desempenho Aeróbio da USP, Escola de Educação Física e Esportes, Universidade de São Paulo, São Paulo, SP, Brasil.'}]",Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas,['10.1590/1414-431X2021e11901']
3128,35239778,Effects of traction therapy on atlantoaxial joint dislocation-induced cervical vertigo.,"Cervical vertigo is a common complication of atlantoaxial joint dislocation. However, there is no consensus on the effects of different therapies on the recovery of the patients suffering cervical vertigo. The objective of this randomized controlled trial was to investigate the effect of traction therapy on reducing cervical vertigo induced by atlantoaxial joint dislocation. A total of 96 patients were randomized to receive traction therapy or traditional therapy for two weeks. The overall clinical efficacy was measured based on the 30-point cervical vertigo symptom and function evaluation form. The therapeutic effects were also evaluated based on lateral atlantodental space (LADS), vertigo scale, neck and shoulder pain scale, headache scale, daily life and work scale, psychosocial adaptation scale, and quality of life. Compared with the traditional therapy group, the traction group demonstrated markedly higher overall clinical efficacy (P=0.038). Both the traction therapy group and the traditional therapy group showed significant decrease in LADS (P<0.001), but the traction therapy group had a greater reduction of LAD compared with the traditional group (P<0.01). Traction therapy consistently led to significantly greater relief of cervical vertigo symptoms, including dizziness, neck and shoulder pain, headache, inconvenience in daily living and work activities, impaired psychosocial adaptation, while improving quality of life. The efficacy of traction therapy for cervical vertigo surpasses that of traditional therapy, suggesting that traction therapy is potentially more clinically useful in treating these patients.",2022,"Compared with the traditional therapy group, the traction group demonstrated markedly higher overall clinical efficacy (P=0.038).","['96 patients', 'patients suffering cervical vertigo', 'atlantoaxial joint dislocation-induced cervical vertigo']","['traction therapy', 'traction therapy or traditional therapy', 'Traction therapy']","['LAD', 'relief of cervical vertigo symptoms, including dizziness, neck and shoulder pain, headache, inconvenience in daily living and work activities, impaired psychosocial adaptation, while improving quality of life', 'lateral atlantodental space (LADS), vertigo scale, neck and shoulder pain scale, headache scale, daily life and work scale, psychosocial adaptation scale, and quality of life', 'Cervical vertigo', 'LADS', 'overall clinical efficacy', 'cervical vertigo']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0395922', 'cui_str': 'Cervical vertigo'}, {'cui': 'C0004168', 'cui_str': 'Structure of atlantoaxial joint'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0395922', 'cui_str': 'Cervical vertigo'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",96.0,0.0207672,"Compared with the traditional therapy group, the traction group demonstrated markedly higher overall clinical efficacy (P=0.038).","[{'ForeName': 'Genghui', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'Department of Rehabilitation, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}, {'ForeName': 'Dabin', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Department of Rehabilitation, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}, {'ForeName': 'Jieyun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}, {'ForeName': 'Xiuyao', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Department of Rehabilitation, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}, {'ForeName': 'Ri', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}]",Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas,['10.1590/1414-431X2022e11777']
3129,35240094,ROAR trial: which treatment is effective after progression?,,2022,,[],[],[],[],[],[],,0.096783,,"[{'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Sütcüoğlu', 'Affiliation': 'Department of Medical Oncology, Gazi University, Ankara 06560, Turkey. Electronic address: sutcuogluo@gmail.com.'}, {'ForeName': 'Kadriye Bir', 'Initials': 'KB', 'LastName': 'Yücel', 'Affiliation': 'Department of Medical Oncology, Gazi University, Ankara 06560, Turkey.'}, {'ForeName': 'Aytuğ', 'Initials': 'A', 'LastName': 'Üner', 'Affiliation': 'Department of Medical Oncology, Gazi University, Ankara 06560, Turkey.'}, {'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Yazici', 'Affiliation': 'Department of Medical Oncology, Gazi University, Ankara 06560, Turkey.'}, {'ForeName': 'Nuriye', 'Initials': 'N', 'LastName': 'Özdemir', 'Affiliation': 'Department of Medical Oncology, Gazi University, Ankara 06560, Turkey.'}]",The Lancet. Oncology,['10.1016/S1470-2045(21)00754-3']
3130,35240087,"Stereotactic body radiotherapy plus pembrolizumab and trametinib versus stereotactic body radiotherapy plus gemcitabine for locally recurrent pancreatic cancer after surgical resection: an open-label, randomised, controlled, phase 2 trial.","BACKGROUND


There is paucity of investigations into immunotherapy or targeted therapy for postoperative locally recurrent pancreatic cancer. We aimed to assess the efficacy of stereotactic body radiotherapy (SBRT) plus pembrolizumab and trametinib in these patients.
METHODS


In this open-label, randomised, controlled, phase 2 study, participants were recruited from Changhai Hospital affiliated to the Naval Medical University, Shanghai, China. Eligible patients were aged 18 years or older with histologically confirmed pancreatic ductal adenocarcinoma characterised by mutant KRAS and positive immunohistochemical staining of PD-L1, Eastern Cooperative Oncology Group performance status of 0 or 1, and documented local recurrence after surgery followed by chemotherapy (mFOLFIRINOX [ie, 5-fluorouracil, oxaliplatin, irinotecan, and folinic acid] or 5-fluorouracil). Eligible participants were randomly assigned (1:1) using an interactive voice or web response system, without stratification, to receive SBRT with doses ranging from 35-40 Gy in five fractions, intravenous pembrolizumab 200 mg once every 3 weeks, and oral trametinib 2 mg once daily or SBRT (same regimen) and intravenous gemcitabine (1000 mg/m 2 ) on day 1 and 8 of a 21-day cycle for eight cycles until disease progression, death, unacceptable toxicity, or consent withdrawal. The primary endpoint was overall survival in the intention-to-treat population. Safety was assessed in the as-treated population in all participants who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, NCT02704156, and is now complete.
FINDINGS


Between Oct 10, 2016, and Oct 28, 2017, 198 patients were screened, of whom 170 patients were enrolled and randomly assigned to receive SBRT plus pembrolizumab and trametinib (n=85) or SBRT plus gemcitabine (n=85). As of the clinical cutoff date (Nov 30, 2020), median follow-up was 13·1 months (IQR 10·2-17·1). Median overall survival was 14·9 months (12·7-17·1) with SBRT plus pembrolizumab and trametinib and 12·8 months (95% CI 11·2-14·4) with SBRT plus gemcitabine (hazard ratio [HR] 0·69 [95% CI 0·51-0·95]; p=0·021). The most common grade 3 or 4 adverse effects were increased alanine aminotransferase or aspartate aminotransferase (ten [12%] of 85 in SBRT plus pembrolizumab and trametinib group vs six [7%] of 85 in SBRT plus gemcitabine group), increased blood bilirubin (four [5%] vs none), neutropenia (one [1%] vs nine [11%]), and thrombocytopenia (one [1%] vs four [5%]). Serious adverse events were reported by 19 (22%) participants in the SBRT plus pembrolizumab and trametinib group and 12 (14%) in the SBRT plus gemcitabine group. No treatment-related deaths occurred.
INTERPRETATION


The combination of SBRT plus pembrolizumab and trametinib could be a novel treatment option for patients with locally recurrent pancreatic cancer after surgery. Phase 3 trials are needed to confirm our findings.
FUNDING


Shanghai Shenkang Center and Changhai Hospital.
TRANSLATION


For the Chinese translation of the abstract see Supplementary Materials section.",2022,Serious adverse events were reported by 19 (22%) participants in the SBRT plus pembrolizumab and trametinib group and 12 (14%) in the SBRT plus gemcitabine group.,"['Eligible participants', 'patients with locally recurrent pancreatic cancer after surgery', 'Between Oct 10, 2016, and Oct 28, 2017, 198 patients were screened, of whom 170 patients', 'postoperative locally recurrent pancreatic cancer', 'locally recurrent pancreatic cancer after surgical resection', 'Eligible patients were aged 18 years or older with histologically confirmed pancreatic ductal adenocarcinoma characterised by mutant KRAS and positive immunohistochemical staining of PD-L1, Eastern Cooperative Oncology Group performance status of 0 or 1, and documented local recurrence after surgery followed by', '0·69', 'participants were recruited from Changhai Hospital affiliated to the Naval Medical University, Shanghai, China']","['SBRT plus pembrolizumab', 'interactive voice or web response system, without stratification, to receive SBRT with doses ranging from 35-40 Gy in five fractions, intravenous pembrolizumab 200 mg once every 3 weeks, and oral trametinib 2 mg once daily or SBRT (same regimen) and intravenous gemcitabine', 'immunotherapy', 'SBRT plus pembrolizumab and trametinib (n=85) or SBRT plus gemcitabine', 'stereotactic body radiotherapy (SBRT) plus pembrolizumab', 'Stereotactic body radiotherapy plus pembrolizumab and trametinib versus stereotactic body radiotherapy plus gemcitabine', 'gemcitabine', 'chemotherapy (mFOLFIRINOX [ie, 5-fluorouracil, oxaliplatin, irinotecan, and folinic acid] or 5-fluorouracil', 'SBRT plus gemcitabine']","['Safety', 'Median overall survival', 'alanine aminotransferase or aspartate aminotransferase', 'blood bilirubin', 'thrombocytopenia', 'Serious adverse events', 'neutropenia', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0854777', 'cui_str': 'Pancreatic carcinoma recurrent'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3644516', 'cui_str': 'trametinib 2 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0863174', 'cui_str': 'Blood bilirubin'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",198.0,0.133539,Serious adverse events were reported by 19 (22%) participants in the SBRT plus pembrolizumab and trametinib group and 12 (14%) in the SBRT plus gemcitabine group.,"[{'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiation Oncology, Changhai Hospital affiliated to Naval Medical University, Shanghai, China.'}, {'ForeName': 'Yangsen', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Radiation Oncology, Changhai Hospital affiliated to Naval Medical University, Shanghai, China.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Changhai Hospital affiliated to Naval Medical University, Shanghai, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Ju', 'Affiliation': 'Department of Radiation Oncology, Changhai Hospital affiliated to Naval Medical University, Shanghai, China.'}, {'ForeName': 'Xianzhi', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiation Oncology, Changhai Hospital affiliated to Naval Medical University, Shanghai, China.'}, {'ForeName': 'Lingong', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiation Oncology, Changhai Hospital affiliated to Naval Medical University, Shanghai, China.'}, {'ForeName': 'Yusheng', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Department of Radiation Oncology, Changhai Hospital affiliated to Naval Medical University, Shanghai, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Jin', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, Changhai Hospital affiliated to Naval Medical University, Shanghai, China. Electronic address: jingang@hotmail.com.'}, {'ForeName': 'Huojun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Changhai Hospital affiliated to Naval Medical University, Shanghai, China. Electronic address: chyyzhj@163.com.'}]",The Lancet. Oncology,['10.1016/S1470-2045(22)00066-3']
3131,35240084,"Multiparametric ultrasound versus multiparametric MRI to diagnose prostate cancer (CADMUS): a prospective, multicentre, paired-cohort, confirmatory study.","BACKGROUND


Multiparametric MRI of the prostate followed by targeted biopsy is recommended for patients at risk of prostate cancer. However, multiparametric ultrasound is more readily available than multiparametric MRI. Data from paired-cohort validation studies and randomised, controlled trials support the use of multiparametric MRI, whereas the evidence for individual ultrasound methods and multiparametric ultrasound is only derived from case series. We aimed to establish the overall agreement between multiparametric ultrasound and multiparametric MRI to diagnose clinically significant prostate cancer.
METHODS


We conducted a prospective, multicentre, paired-cohort, confirmatory study in seven hospitals in the UK. Patients at risk of prostate cancer, aged 18 years or older, with an elevated prostate-specific antigen concentration or abnormal findings on digital rectal examination underwent both multiparametric ultrasound and multiparametric MRI. Multiparametric ultrasound consisted of B-mode, colour Doppler, real-time elastography, and contrast-enhanced ultrasound. Multiparametric MRI included high-resolution T2-weighted images, diffusion-weighted imaging (dedicated high B 1400 s/mm 2  or 2000 s/mm 2  and apparent diffusion coefficient map), and dynamic contrast-enhanced axial T1-weighted images. Patients with positive findings on multiparametric ultrasound or multiparametric MRI underwent targeted biopsies but were masked to their test results. If both tests yielded positive findings, the order of targeting at biopsy was randomly assigned (1:1) using stratified (according to centre only) block randomisation with randomly varying block sizes. The co-primary endpoints were the proportion of positive lesions on, and agreement between, multiparametric MRI and multiparametric ultrasound in identifying suspicious lesions (Likert score of ≥3), and detection of clinically significant cancer (defined as a Gleason score of ≥4 + 3 in any area or a maximum cancer core length of ≥6 mm of any grade [PROMIS definition 1]) in those patients who underwent a biopsy. Adverse events were defined according to Good Clinical Practice and trial regulatory guidelines. The trial is registered on ISRCTN, 38541912, and ClinicalTrials.gov, NCT02712684, with recruitment and follow-up completed.
FINDINGS


Between March 15, 2016, and Nov 7, 2019, 370 eligible patients were enrolled; 306 patients completed both multiparametric ultrasound and multiparametric MRI and 257 underwent a prostate biopsy. Multiparametric ultrasound was positive in 272 (89% [95% CI 85-92]) of 306 patients and multiparametric MRI was positive in 238 patients (78% [73-82]; difference 11·1% [95% CI 5·1-17·1]). Positive test agreement was 73·2% (95% CI 67·9-78·1; κ=0·06 [95% CI -0·56 to 0·17]). Any cancer was detected in 133 (52% [95% CI 45·5-58]) of 257 patients, with 83 (32% [26-38]) of 257 being clinically significant by PROMIS definition 1. Each test alone would result in multiparametric ultrasound detecting PROMIS definition 1 cancer in 66 (26% [95% CI 21-32]) of 257 patients who had biopsies and multiparametric MRI detecting it in 77 (30% [24-36]; difference -4·3% [95% CI -8·3% to -0·3]). Combining both tests detected 83 (32% [95% CI 27-38]) of 257 clinically significant cancers as per PROMIS definition 1; of these 83 cancers, six (7% [95% CI 3-15]) were detected exclusively with multiparametric ultrasound, and 17 (20% [12-31]) were exclusively detected by multiparametric MRI (agreement 91·1% [95% CI 86·9-94·2]; κ=0·78 [95% CI 0·69-0·86]). No serious adverse events were related to trial activity.
INTERPRETATION


Multiparametric ultrasound detected 4·3% fewer clinically significant prostate cancers than multiparametric MRI, but it would lead to 11·1% more patients being referred for a biopsy. Multiparametric ultrasound could be an alternative to multiparametric MRI as a first test for patients at risk of prostate cancer, particularly if multiparametric MRI cannot be carried out. Both imaging tests missed clinically significant cancers detected by the other, so the use of both would increase the detection of clinically significant prostate cancers compared with using each test alone.
FUNDING


The Jon Moulton Charity Trust, Prostate Cancer UK, and UCLH Charity and Barts Charity.",2022,Multiparametric ultrasound was positive in 272 (89% [95% CI 85-92]) of 306 patients and multiparametric MRI was positive in 238 patients (78% [73-82]; difference 11·1% [95% CI 5·1-17·1]).,"['Patients at risk of prostate cancer, aged 18 years or older, with an elevated prostate-specific antigen concentration or abnormal findings on digital rectal examination underwent both multiparametric ultrasound and multiparametric MRI', 'patients at risk of prostate cancer', 'Between March 15, 2016, and Nov 7, 2019, 370 eligible patients were enrolled; 306 patients completed both multiparametric ultrasound and multiparametric MRI and 257 underwent a prostate biopsy', 'seven hospitals in the UK', 'Patients with positive findings on multiparametric ultrasound or multiparametric MRI underwent targeted biopsies']","['Multiparametric ultrasound versus multiparametric MRI', 'multiparametric ultrasound and multiparametric MRI', 'Multiparametric ultrasound consisted of B-mode, colour Doppler, real-time elastography, and contrast-enhanced ultrasound']","['proportion of positive lesions on, and agreement between, multiparametric MRI and multiparametric ultrasound in identifying suspicious lesions (Likert score of ≥3), and detection of clinically significant cancer', 'Multiparametric ultrasound', 'serious adverse events', 'multiparametric MRI', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0199900', 'cui_str': 'Rectal examination'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1955928', 'cui_str': 'Tissue Elasticity Imaging'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",370.0,0.236757,Multiparametric ultrasound was positive in 272 (89% [95% CI 85-92]) of 306 patients and multiparametric MRI was positive in 238 patients (78% [73-82]; difference 11·1% [95% CI 5·1-17·1]).,"[{'ForeName': 'Alistair D R', 'Initials': 'ADR', 'LastName': 'Grey', 'Affiliation': 'Division of Surgical and Interventional Sciences, University College London, London, UK; Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK; Department of Urology, Barts Health NHS Trust, London, UK; Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Scott', 'Affiliation': 'Division of Surgical and Interventional Sciences, University College London, London, UK.'}, {'ForeName': 'Bina', 'Initials': 'B', 'LastName': 'Shah', 'Affiliation': 'Surgical and Interventional Trials Unit, Division of Surgical and Interventional Sciences, University College London, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Acher', 'Affiliation': 'Department of Urology, Southend University Hospital, Southend, UK.'}, {'ForeName': 'Sidath', 'Initials': 'S', 'LastName': 'Liyanage', 'Affiliation': 'Department of Radiology, Southend University Hospital, Southend, UK.'}, {'ForeName': 'Menelaos', 'Initials': 'M', 'LastName': 'Pavlou', 'Affiliation': 'Faculty of Medical Sciences, and Department of Statistical Science, University College London, London, UK.'}, {'ForeName': 'Rumana', 'Initials': 'R', 'LastName': 'Omar', 'Affiliation': 'Faculty of Medical Sciences, and Department of Statistical Science, University College London, London, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Chinegwundoh', 'Affiliation': 'Department of Urology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Patki', 'Affiliation': 'Department of Urology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Taimur T', 'Initials': 'TT', 'LastName': 'Shah', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Hamid', 'Affiliation': 'Department of Urology, The Whittington Hospital NHS Trust, London, UK.'}, {'ForeName': 'Maneesh', 'Initials': 'M', 'LastName': 'Ghei', 'Affiliation': 'Department of Urology, The Whittington Hospital NHS Trust, London, UK.'}, {'ForeName': 'Kayleigh', 'Initials': 'K', 'LastName': 'Gilbert', 'Affiliation': 'Department of Urology, The Whittington Hospital NHS Trust, London, UK.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Department of Urology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brew-Graves', 'Affiliation': 'Surgical and Interventional Trials Unit, Division of Surgical and Interventional Sciences, University College London, London, UK.'}, {'ForeName': 'Nimalan', 'Initials': 'N', 'LastName': 'Arumainayagam', 'Affiliation': 'Department of Urology, Ashford and St Peters Hospitals NHS Trust, Chertsey, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Chapman', 'Affiliation': 'Department of Radiology, Ashford and St Peters Hospitals NHS Trust, Chertsey, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McLeavy', 'Affiliation': 'Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Karatziou', 'Affiliation': 'Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Zayneb', 'Initials': 'Z', 'LastName': 'Alsaadi', 'Affiliation': 'Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Collins', 'Affiliation': 'Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Freeman', 'Affiliation': 'Department of Histopathology, University College London Hospitals, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Eldred-Evans', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Bertoncelli-Tanaka', 'Affiliation': 'Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Tam', 'Affiliation': 'Department of Radiology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Ramachandran', 'Affiliation': 'Department of Radiology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Madaan', 'Affiliation': 'Department of Urology, Darent Valley Hospital, Dartford, UK.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Winkler', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Manit', 'Initials': 'M', 'LastName': 'Arya', 'Affiliation': 'Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK; Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Emberton', 'Affiliation': 'Division of Surgical and Interventional Sciences, University College London, London, UK; Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Hashim U', 'Initials': 'HU', 'LastName': 'Ahmed', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK. Electronic address: hashim.ahmed@imperial.ac.uk.'}]",The Lancet. Oncology,['10.1016/S1470-2045(22)00016-X']
3132,35236510,Implementation of an ED surge management platform: a study protocol.,"BACKGROUND


Emergency departments (EDs) around the world are struggling with long wait times and overcrowding. To address these issues, a quality improvement program called SurgeCon was created to improve ED efficiency and patient satisfaction. This paper presents a framework for managing and evaluating the implementation of an ED surge management platform. Our framework builds on the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to structure our approach and the Consolidated Framework for Implementation Research (CFIR) to guide our choice of outcome variables and scalability.
METHODS


Four hospital EDs will receive the SurgeCon quality improvement intervention. Using a stepped wedge cluster design, each ED will be randomized to one of four start dates. Data will be collected before, during, and after the implementation of the intervention. RE-AIM will be used to guide the assessment of SurgeCon, and guided by CFIR, we will measure ED key performance indicators (KPI), patient-reported outcomes, and implementation outcomes related to SurgeCon's scalability, adaptability, sustainability, and overall costs. Participants in this study consist of patients who visit any of the four selected EDs during the study period, providers/staff, and health system managers. A mixed-methods approach will be utilized to evaluate implementation outcomes.
DISCUSSION


This study will provide important insight into the implementation and evaluation techniques to enhance uptake and benefits associated with an ED surge-management platform. The proposed framework bridges research and practice by involving researchers, practitioners, and patients in the implementation and evaluation process, to produce an actionable framework that others can follow. We anticipate that the implementation approach would be generalizable to program implementations in other EDs.
TRIAL REGISTRATION


• Name of the registry: ClinicalTrials.gov • Trial registration number: NCT04789902 • Date of registration: 03/10/2021.",2022,"Our framework builds on the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to structure our approach and the Consolidated Framework for Implementation Research (CFIR) to guide our choice of outcome variables and scalability.
","['Participants in this study consist of patients who visit any of the four selected EDs during the study period, providers/staff, and health system managers']",[],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0335141', 'cui_str': 'Manager'}]",[],[],4.0,0.065176,"Our framework builds on the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to structure our approach and the Consolidated Framework for Implementation Research (CFIR) to guide our choice of outcome variables and scalability.
","[{'ForeName': 'Nahid Rahimipour', 'Initials': 'NR', 'LastName': 'Anaraki', 'Affiliation': ""Centre for Rural Health Studies, Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, A1B 3V6, Canada.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jewer', 'Affiliation': ""Faculty of Business Administration, Memorial University of Newfoundland, St. John's, NL, A1B 3V6, Canada.""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Hurley', 'Affiliation': ""Centre for Rural Health Studies, Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, A1B 3V6, Canada.""}, {'ForeName': 'Hensley H', 'Initials': 'HH', 'LastName': 'Mariathas', 'Affiliation': ""Centre for Rural Health Studies, Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, A1B 3V6, Canada.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Young', 'Affiliation': ""Centre for Rural Health Studies, Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, A1B 3V6, Canada.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Norman', 'Affiliation': 'Eastern Health, Carbonear Institute for Rural Research and Innovation by the Sea, Carbonear General Hospital, Carbonear, NL, A1Y 1A4, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Patey', 'Affiliation': ""Discipline of Family Medicine, Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, A1B 3V6, Canada.""}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Wilson', 'Affiliation': ""Community Health and Humanities, Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, A1B 3V6, Canada.""}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Etchegary', 'Affiliation': ""Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, A1B 3V6, Canada.""}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Senior', 'Affiliation': ""Patient Advisory Council, NLSUPPORT, Memorial University of Newfoundland, St. John's, NL, A1B 3V6, Canada.""}, {'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': ""Centre for Rural Health Studies, Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, A1B 3V6, Canada. Shabnam.Asghari@med.mun.ca.""}]",Implementation science communications,['10.1186/s43058-021-00247-1']
3133,35236473,Retraction Note: Patelloplasty in total knee arthroplasty with circumpatellar denervation versus without denervation - a randomized prospective study.,,2021,,['total knee arthroplasty with circumpatellar denervation versus without denervation '],[],[],"[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0011307', 'cui_str': 'Denervation - action'}]",[],[],,0.0347481,,"[{'ForeName': 'S R K', 'Initials': 'SRK', 'LastName': 'Deekshith', 'Affiliation': 'Department of Orthopedics, SVS Medical College and Hospital, Mahabubnagar, Telangana State, 500062, India. srkdikshith@gmail.com.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Reddy', 'Affiliation': 'Department of Orthopedics, SVS Medical College and Hospital, Mahabubnagar, Telangana State, 500062, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Raviteja', 'Affiliation': 'Department of Orthopedics, SVS Medical College and Hospital, Mahabubnagar, Telangana State, 500062, India.'}]","Arthroplasty (London, England)",['10.1186/s42836-021-00076-6']
3134,35236467,Does intraoperative mechanical prophylaxis prevent venous thromboembolism in total knee arthroplasty? - effectiveness of passive-assisted ankle motion in surgical/non-surgical side.,"BACKGROUND


Gradual compression stocking (GCS) and intermittent pneumatic compression device (IPCD) are used for intraoperative mechanical prophylaxis against venous thromboembolism (VTE) during total knee arthroplasty (TKA). In this study, we applied a passive-assisted ankle motion in combination with GCS and IPCD during TKA and evaluated its effectiveness in preventing postoperative VTE.
METHODS


We included 77 patients who underwent primary unilateral TKA. Patients were divided into group A (53 patients who underwent GCS and IPCD on their non-surgical side limb) and group B (24 patients who underwent passive ankle dorsiflexion motion in addition to GCS and IPCD on their non-surgical side limb). Deep vein thrombosis (DVT) was assessed using lower extremity ultrasonography (US). The incidence of VTE in each affected limb was compared between the two groups.
RESULTS


US was performed 4 days after surgery on average. The incidence of DVT in groups A and B was 47.2 and 70.8 %, respectively. In group A, 22.6 % of DVTs were found only on the surgical side, 11.3 % on the non-surgical side, and 13.2 % on both sides. On the other hand, in group B, 41.7 % of DVTs were found only on the surgical side, 4.2 % on the non-surgical side, and 25.0 % on both sides. No significant difference in the incidence of VTE was noted between the 2 groups.
CONCLUSIONS


The intraoperative application of passive ankle motion plus GCS and IPCD might not further reduce the incidence of postoperative DVT in TKA patients.",2021,"No significant difference in the incidence of VTE was noted between the 2 groups.
","['TKA patients', 'total knee arthroplasty (TKA', '77 patients who underwent primary unilateral TKA']","['intraoperative mechanical prophylaxis', 'Gradual compression stocking (GCS) and intermittent pneumatic compression device (IPCD', 'GCS and IPCD on their non-surgical side limb', 'passive ankle dorsiflexion motion in addition to GCS and IPCD on their non-surgical side limb', 'passive-assisted ankle motion']","['incidence of DVT', 'Deep vein thrombosis (DVT', 'incidence of VTE']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C1449835', 'cui_str': 'Intermittent pneumatic compression device'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",77.0,0.0395481,"No significant difference in the incidence of VTE was noted between the 2 groups.
","[{'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Tateiwa', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, 6-7-1, Nishishinjuku, Shinjuku-ku, 160-0023, Tokyo, Japan. tateiwa@tokyo-med.ac.jp.'}, {'ForeName': 'Tsunehito', 'Initials': 'T', 'LastName': 'Ishida', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, 6-7-1, Nishishinjuku, Shinjuku-ku, 160-0023, Tokyo, Japan.'}, {'ForeName': 'Toshinori', 'Initials': 'T', 'LastName': 'Masaoka', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, 6-7-1, Nishishinjuku, Shinjuku-ku, 160-0023, Tokyo, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Shishido', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, 6-7-1, Nishishinjuku, Shinjuku-ku, 160-0023, Tokyo, Japan.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, 6-7-1, Nishishinjuku, Shinjuku-ku, 160-0023, Tokyo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Nishida', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, 6-7-1, Nishishinjuku, Shinjuku-ku, 160-0023, Tokyo, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, 6-7-1, Nishishinjuku, Shinjuku-ku, 160-0023, Tokyo, Japan.'}]","Arthroplasty (London, England)",['10.1186/s42836-021-00088-2']
3135,35236455,Reliability and validity of 3 different Chinese versions of the Oxford knee score (OKS).,"BACKGROUND


Different Chinese versions of the Oxford Knee Score (OKS) are available for knee arthritis assessment. These include the Malaysian, Hong Kong and Singaporean Chinese versions with slight variations in wordings and use of Cantonese in the Hong Kong Version. This study evaluated the validity and reliability of the different Chinese OKS versions in Mainland China.
METHODS


One hundred ninety four China mainland-based patients participated in the study, each being diagnosed with knee osteoarthritis. The patients were randomly assigned into 3 groups: Group A completed the Malaysian OKS; Group B completed the Singaporean OKS; Group C completed the Hong Kong OKS. Participants also completed the 36-item Short Form Survey (SF 36). The electronic versions of the questionnaires completed by the patients were sent to smart devices via a social media platform.
RESULTS


Interclass coefficients for test-retest reliability of the groups were 0.917 in group A, 0.921 in group B, 0.824 in group C. Cronbach alpha results for internal consistency of the 3 groups were: 0.912 in group A, 0.896 in group B, 0.846 in group C. Spearson correlation results with individual SF-36 domains were as follows: Group A showed strong negative correlations with bodily pain and physical function domains; group B exhibited moderate negative correlations with the bodily pain and physical function domains; group C revealed strong negative correlations with the bodily pain and physical function domains and weak negative correlations with vitality domain.
CONCLUSIONS


Different Chinese versions of the OKS showed good reliability and convergent validity in mainland samples of patients with knee osteoarthritis, supporting their use in research and other related studies.",2020,"RESULTS


Interclass coefficients for test-retest reliability of the groups were 0.917 in group A, 0.921 in group B, 0.824 in group C. Cronbach alpha results for internal consistency of the 3 groups were: 0.912 in group A, 0.896 in group B, 0.846 in group C. Spearson correlation results with individual SF-36 domains were as follows:","['patients with knee osteoarthritis', 'One hundred ninety four China mainland-based patients participated in the study, each being diagnosed with knee osteoarthritis']",['Malaysian OKS; Group B completed the Singaporean OKS; Group C completed the Hong Kong OKS'],"['bodily pain and physical function domains', 'Reliability and validity of 3 different Chinese versions of the Oxford knee score (OKS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0035036', 'cui_str': 'Reliability and Validity'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}]",194.0,0.0151731,"RESULTS


Interclass coefficients for test-retest reliability of the groups were 0.917 in group A, 0.921 in group B, 0.824 in group C. Cronbach alpha results for internal consistency of the 3 groups were: 0.912 in group A, 0.896 in group B, 0.846 in group C. Spearson correlation results with individual SF-36 domains were as follows:","[{'ForeName': 'James Reeves Mbori', 'Initials': 'JRM', 'LastName': 'Ngwayi', 'Affiliation': 'School of Clinical Medicine, Tsinghua University, Beijing, 100084, China. zipromax@163.com.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'School of Clinical Medicine, Tsinghua University, Beijing, 100084, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Liang', 'Affiliation': 'School of Clinical Medicine, Tsinghua University, Beijing, 100084, China.'}, {'ForeName': 'Daniel Edward', 'Initials': 'DE', 'LastName': 'Porter', 'Affiliation': 'Department of Orthopedics, Beijing Huaxin Hospital, Clinical Medicine School, Tsinghua University, Beijing, 100016, China.'}]","Arthroplasty (London, England)",['10.1186/s42836-020-00049-1']
3136,35236751,Reappraisal Bias and Sexual Victimization: Testing the Utility of a Computerized Intervention for Negative Post-Assault Support Experiences.,"Women are at notable risk for negative reactions from others following sexual victimization which serve to intensify negative post-traumatic outcomes. The current study tested the effectiveness of cognitive bias modification-appraisal (CBM-App) training targeting post-traumatic cognitions theorized to be impacted by positive and negative social support with 45 female undergraduates, grouped by experiencing overall positive or negative post-assault support. Whereas all participants experienced improvements in post-traumatic cognitions at 1-week follow-up, a crossover effect for intrusion symptoms was found; CBM-App training reduced intrusions in participants with negative support experiences yet increased intrusions in participants with positive support experiences. While findings highlight the need for careful selection of post-trauma interventions, the study is the first to integrate findings from CBM-App, sexual assault, and social support literature. Socially relevant post-traumatic cognitions appear to be malleable and may be an important focus of treatment for survivors who experienced negative post-assault support.",2021,Socially relevant post-traumatic cognitions appear to be malleable and may be an important focus of treatment for survivors who experienced negative post-assault support.,"['45 female undergraduates, grouped by experiencing overall positive or negative post-assault support']",['cognitive bias modification-appraisal (CBM-App) training'],"['Reappraisal Bias and Sexual Victimization', 'post-traumatic cognitions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0263117,Socially relevant post-traumatic cognitions appear to be malleable and may be an important focus of treatment for survivors who experienced negative post-assault support.,"[{'ForeName': 'Caitlin M', 'Initials': 'CM', 'LastName': 'Pinciotti', 'Affiliation': 'Rogers Behavioral Health System, Oconomowoc, Wisconsin Caitlin.Pinciotti@rogersbh.org.'}, {'ForeName': 'Holly K', 'Initials': 'HK', 'LastName': 'Orcutt', 'Affiliation': 'Northern Illinois University, DeKalb, Illinois.'}]",Journal of cognitive psychotherapy,['10.1891/JCPSY-D-20-00053']
3137,35236735,"Study protocol for a double-blind, comparative, randomised Japanese trial of triplet standard antiemetic therapies with or without 5 mg olanzapine to prevent chemotherapy-induced nausea and vomiting for patients with breast cancer treated with an anthracycline/cyclophosphamide regimen (JTOP-B).","INTRODUCTION


Triple antiemetic therapy with neurokinin-1 receptor antagonist, 5-hydroxytryptamine type 3 receptor antagonist, and dexamethasone has been widely recommended for high emetogenic chemotherapeutic (HEC) agents and regimens, including anthracycline combined with cyclophosphamide (AC). The addition of olanzapine (OLZ) 5 mg or 10 mg to the recommended triple antiemetic therapy has demonstrated superiority in antiemetic efficacy compared with the standard triplet therapy for a cisplatin-based HEC regimen. Although OLZ plus the triple antiemetic treatment may also be effective for patients on an AC-based HEC regimen, no study has investigated its efficacy at a lower dose of 5 mg.
METHODS AND ANALYSIS


To assess whether 5 mg OLZ, as compared with placebo, in combination with triple combination therapy, significantly improves nausea and vomiting, we are conducting a randomised, parallel-group controlled clinical trial with a total of 500 patients at 15 study centres in Japan. The primary outcome is the complete response rate, defined as no emetic episodes and no use of rescue medication during 120 hours after the initiation of chemotherapy. Treatment group comparison for the primary endpoint will be done by using the Cochran-Mantel-Haenszel test.
ETHICS AND DISSEMINATION


The study was approved by the institutional review board of Juntendo University Hospital and relevant approval was obtained from all participating centres. All participants will be required to provide written informed consent. The trial results will be reported at conferences and in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


Japan Registry of Clinical Trials (jRCT) jRCT1031200134; protocol date: 30 July 2020, version: 1.3, approval: 25 August 2020.",2022,"The primary outcome is the complete response rate, defined as no emetic episodes and no use of rescue medication during 120 hours after the initiation of chemotherapy.","['regimen (JTOP-B', '500 patients at 15 study centres in Japan', 'patients with breast cancer treated with an']","['anthracycline/cyclophosphamide', 'placebo', 'OLZ', 'dexamethasone', 'olanzapine', 'olanzapine (OLZ', 'anthracycline combined with cyclophosphamide (AC']","['Cochran-Mantel-Haenszel test', 'antiemetic efficacy', 'complete response rate, defined as no emetic episodes and no use of rescue medication', 'nausea and vomiting']","[{'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",500.0,0.219288,"The primary outcome is the complete response rate, defined as no emetic episodes and no use of rescue medication during 120 hours after the initiation of chemotherapy.","[{'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Ozeki', 'Affiliation': 'Department of Breast Oncology, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hirotoshi', 'Initials': 'H', 'LastName': 'Iihara', 'Affiliation': 'Department of Pharmacy, Gifu University Hospital, Gifu, Japan mitsue@juntendo.ac.jp dai0920@gifu-u.ac.jp.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Biostatistics, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Pharmacy, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Abe', 'Affiliation': 'Department of Obstetrics and Gynecology, Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Mukohara', 'Affiliation': 'Department of Medical Oncology, National Cancer Center-Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Department of Breast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Toshinobu', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Comprehensive Pharmaceutical Care, Faculty of Pharmaceutical Sciences, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kawazoe', 'Affiliation': 'Division of Pharmaceutical Care Sciences, Center for Social Pharmacy and Pharmaceutical Care Sciences, Keio University Faculty of Pharmacy, Tokyo, Japan.'}, {'ForeName': 'Masayo', 'Initials': 'M', 'LastName': 'Komoda', 'Affiliation': 'Faculty of Pharmaceutical Sciences, Tokyo University of Science, Chiba, Japan.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Yanai Takahashi', 'Affiliation': 'Department of Pharmacy, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Mitsue', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'Department of Breast Oncology, Juntendo University School of Medicine, Tokyo, Japan mitsue@juntendo.ac.jp dai0920@gifu-u.ac.jp.'}]",BMJ open,['10.1136/bmjopen-2021-058755']
3138,35236727,Inspiratory Muscle Training Enhances Recovery Post COVID-19: A Randomised Controlled Trial.,"BACKGROUND


Many people recovering from COVID-19 experience prolonged symptoms, particularly breathlessness. We urgently need to identify safe and effective COVID-19 rehabilitative strategies. The aim of the current study was to investigate the potential rehabilitative role of inspiratory muscle training (IMT).
METHODS


281 adults (46.6±12.2 years; 88% female) recovering from self-reported COVID-19 (9.0±4.2 months post-acute infection) were randomised 4:1 to an 8-week IMT or a ""usual care"" wait list control arm. Health-related quality of life and breathlessness questionnaires (King's Brief Interstitial Lung Disease (KBILD) and Transition Dyspnoea Index (TDI)), respiratory muscle strength and fitness (Chester Step Test) were assessed pre- and post-intervention. The primary endpoint was KBILD total score, with the KBILD subdomains and TDI being key secondary outcomes.
RESULTS


According to intention to treat (ITT), there was no difference between groups in KBILD total score post-intervention (Control: 59.5±12.4; IMT: 58.2±12.3; p<0.05) but IMT elicited clinically meaningful improvements in the KBILD subdomains of breathlessness (Control: 59.8±12.6; IMT: 62.2±16.2; p<0.05) and chest symptoms (Control: 59.2±18.7; IMT: 64.5±18.2; p<0.05), along with clinically meaningful improvements in breathlessness according to TDI (Control: 0.9±1.7  versus  2.0±2.0; p<0.05). IMT also improved respiratory muscle strength and estimated aerobic fitness.
CONCLUSIONS


IMT may represent an important home-based rehabilitation strategy for wider implementation as part of COVID-19 rehabilitative strategies. Given the diverse nature of long-COVID, further research is warranted on the individual responses to rehabilitation - the withdrawal rate herein highlights that no one strategy is likely to be appropriate for all.",2022,"According to intention to treat (ITT), there was no difference between groups in KBILD total score post-intervention (Control: 59.5±12.4; IMT: 58.2±12.3; p<0.05) but IMT elicited clinically meaningful improvements in the KBILD subdomains of breathlessness (Control: 59.8±12.6; IMT: 62.2±16.2; p<0.05) and chest symptoms (Control: 59.2±18.7; IMT: 64.5±18.2; p<0.05), along with clinically meaningful improvements in breathlessness according to TDI (Control: 0.9±1.7  versus  2.0±2.0; p<0.05).",['281 adults (46.6±12.2\u2005years; 88% female) recovering from self-reported COVID-19 (9.0±4.2\u2005months post-acute infection'],"['IMT or a ""usual care"" wait list control arm', 'IMT', 'inspiratory muscle training (IMT', 'Inspiratory Muscle Training Enhances Recovery Post COVID-19']","['respiratory muscle strength and estimated aerobic fitness', ""Health-related quality of life and breathlessness questionnaires (King's Brief Interstitial Lung Disease (KBILD) and Transition Dyspnoea Index (TDI)), respiratory muscle strength and fitness (Chester Step Test"", 'chest symptoms', 'KBILD total score, with the KBILD subdomains and TDI being key secondary outcomes', 'KBILD subdomains of breathlessness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0275518', 'cui_str': 'Acute infectious disease'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",281.0,0.06478,"According to intention to treat (ITT), there was no difference between groups in KBILD total score post-intervention (Control: 59.5±12.4; IMT: 58.2±12.3; p<0.05) but IMT elicited clinically meaningful improvements in the KBILD subdomains of breathlessness (Control: 59.8±12.6; IMT: 62.2±16.2; p<0.05) and chest symptoms (Control: 59.2±18.7; IMT: 64.5±18.2; p<0.05), along with clinically meaningful improvements in breathlessness according to TDI (Control: 0.9±1.7  versus  2.0±2.0; p<0.05).","[{'ForeName': 'Melitta A', 'Initials': 'MA', 'LastName': 'McNarry', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine Research Centre, Swansea University, Swansea, UK m.mcnarry@swansea.ac.uk.'}, {'ForeName': 'Ronan M G', 'Initials': 'RMG', 'LastName': 'Berg', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Centre for Physical Activity Research, and Department of Clinical Physiology and Nuclear Medicine, University Hospital Copenhagen - Rigshospitalet, Kobenhavn, Denmark.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shelley', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine Research Centre, Swansea University, Swansea, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine Research Centre, Swansea University, Swansea, UK.'}, {'ForeName': 'Zoe L', 'Initials': 'ZL', 'LastName': 'Saynor', 'Affiliation': 'Physical Activity, Health and Rehabilitation Thematic Research Group Lead, School of Sport, Health and Exercise Science, Faculty of Science and Health, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Duckers', 'Affiliation': 'All Wales Adult CF Centre, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Keir', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': 'Hywel Dda University Health Board, Llanelli, UK.'}, {'ForeName': 'Gwyneth A', 'Initials': 'GA', 'LastName': 'Davies', 'Affiliation': 'School of Medicine, Swansea University, Swansea, UK.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Mackintosh', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine Research Centre, Swansea University, Swansea, UK.'}]",The European respiratory journal,['10.1183/13993003.03101-2021']
3139,35236723,Endoscopic Follow-up of Low Grade Precancerous Bronchial Lesions in High-Risk Patients: long-term results of the SELEPREBB randomized multicentre trial.,"BACKGROUND


Three to 9% of low-grade pre-invasive bronchial lesions progress to cancer. This study assessed the usefulness of an intensive bronchoscopy surveillance strategy in patients with bronchial lesions up to moderate squamous dysplasia.
METHODS


SELEPREBB (NCT00213603) was a randomized study conducted in 17 French centers. After baseline lung CT-scan and autofluorescence bronchoscopy (AFB) excluding lung cancer and bronchial severe squamous dysplasia or carcinoma  in situ  (CIS), patients were assigned to standard surveillance (arm A) with CT and AFB at 36 months or to intensive surveillance (arm B) including AFB every 6 months. Further long term data were obtained with a median follow-up of 4.7 years.
RESULTS


364 patients were randomized (A: 180, B: 184). Twenty-seven patients developed invasive lung cancer and 2 developed persistent CIS during the study, without difference between arms (OR=0.63, 95% CI=[0.20-1.96], p=0.42). Mild or moderate dysplasia at baseline bronchoscopy was a significant lung cancer risk factor both at 3 years (8/74 patients, OR=6.9, 95% CI=[2.5-18.9], p<0.001) and at maximum follow-up (16/74, patients, OR=5.9, 95% CI=[2.9-12.0]). Smoking cessation was significantly associated with clearance of bronchial dysplasia on follow-up (OR=0.12, 95% CI=[0.01-0.66], p=0.005) and with a reduced risk of lung cancer at 5 years (OR=0.15, 95% CI=[0.003-0.99], p=0.04).
CONCLUSION


Patients with mild or moderate dysplasia are at very high-risk for lung cancer at 5 years, with smoking cessation significantly reducing the risk. Whereas an intensive bronchoscopy surveillance does not improve patient's outcome, the identification of bronchial dysplasia using initial bronchoscopy maybe useful for risk stratification strategies in lung cancer screening programs.",2022,"Smoking cessation was significantly associated with clearance of bronchial dysplasia on follow-up (OR=0.12, 95% CI=[0.01-0.66], p=0.005) and with a reduced risk of lung cancer at 5 years (OR=0.15, 95% CI=[0.003-0.99], p=0.04).
","['lung cancer and bronchial severe squamous dysplasia or carcinoma  in situ  (CIS', '364 patients were randomized (A: 180, B: 184', '17 French centers', 'Patients with mild or moderate dysplasia', 'patients with bronchial lesions up to moderate squamous dysplasia']","['intensive bronchoscopy surveillance strategy', 'baseline lung CT-scan and autofluorescence bronchoscopy (AFB']","['invasive lung cancer', 'persistent CIS', 'Smoking cessation', 'reduced risk of lung cancer', 'clearance of bronchial dysplasia', 'lung cancer risk factor', 'Mild or moderate dysplasia']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0007099', 'cui_str': 'Carcinoma in situ'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0334047', 'cui_str': 'Moderate dysplasia'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0412611', 'cui_str': 'CT of lungs'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C3164393', 'cui_str': 'Autofluorescence bronchoscopy'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0007099', 'cui_str': 'Carcinoma in situ'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C1112356', 'cui_str': 'Bronchial dysplasia'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0334047', 'cui_str': 'Moderate dysplasia'}]",364.0,0.134034,"Smoking cessation was significantly associated with clearance of bronchial dysplasia on follow-up (OR=0.12, 95% CI=[0.01-0.66], p=0.005) and with a reduced risk of lung cancer at 5 years (OR=0.15, 95% CI=[0.003-0.99], p=0.04).
","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Guisier', 'Affiliation': 'Normandie Univ, UNIROUEN, LITIS Lab QuantIF team EA4108, CHU Rouen, Department of Pneumology and Inserm CIC-CRB 1404, Rouen, France florian.guisier@chu-rouen.fr.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Deslee', 'Affiliation': 'CHU de Reims, Department of Pneumology, Reims, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Birembaut', 'Affiliation': 'CHU de Reims, Laboratoire de Pathologie, Reims, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Escarguel', 'Affiliation': 'Hôpital Saint-Joseph, Department of Pneumology, Marseille, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Chapel', 'Affiliation': ""CHI Toulon La Seyne sur mer, Laboratoire d'anatomie pathologique, Toulon, France.""}, {'ForeName': 'Suzanna', 'Initials': 'S', 'LastName': 'Bota', 'Affiliation': 'CHU Rouen, Department of Pneumology, Rouen, France.'}, {'ForeName': 'Josette', 'Initials': 'J', 'LastName': 'Métayer', 'Affiliation': 'CHU de Rouen, Department of Pathology, Rouen, France.'}, {'ForeName': 'Samy', 'Initials': 'S', 'LastName': 'Lachkar', 'Affiliation': 'CHU Rouen, Department of Pneumology, Rouen, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Capron', 'Affiliation': 'Hôpital Pitié Salepetrière, Department of Pathology, Paris, France.'}, {'ForeName': 'Jean Paul', 'Initials': 'JP', 'LastName': 'Homasson', 'Affiliation': 'Hôpital Chevilly Larue, Department of Pneumology, Chevilly-Larue, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Taulelle', 'Affiliation': 'Hopital Privé Les Franciscaines, Nîmes, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Quintana', 'Affiliation': 'Centre médical de pathologie, Nîmes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Raspaud', 'Affiliation': 'Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Messelet', 'Affiliation': ""Laboratoire d'anatomie et cytologie pathologiques, Toulouse, France.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Benzaquen', 'Affiliation': ""Université Côte d'Azur, Centre Hospitalier Universitaire de Nice, FHU OncoAge, Department of Pulmonary Medicine and Oncology, Nice, France.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hofman', 'Affiliation': ""Université Côte d'Azur, CNRS, INSERM, Institute of Research on Cancer and Aging (IRCAN), Nice, France.""}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Baddredine', 'Affiliation': 'Laboratoire Ouest Pathologie, Rennes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Paris', 'Affiliation': 'INSERM U1085 IRSET & Service de Santé au Travail & de Pathologie Professionnelle et Environnementale, CHRU Pontchaillou, Rennes, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Cales', 'Affiliation': ""Laboratoire d'anatomie pathologique, CH de Pau, Pau, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Laurent', 'Affiliation': 'CH François Mitterand, Service de pneumologie, Pau, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Vignaud', 'Affiliation': ""Hôpital Central, Laboratoire d'anatomie pathologique, Nancy, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Ménard', 'Affiliation': 'CHU Nancy, Hôpital Brabois, Service de pneumologie, Vandoeuvre les Nancy, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Copin', 'Affiliation': 'Univ Lille, CHRU Lille, Institut de Pathologie, Avenue Oscar Lambret, Lille, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ramon', 'Affiliation': 'CHRU Lille, Hôpital Calmette, Clinique des maladies respiratoires, Lille, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Bouchindhomme', 'Affiliation': ""CH Lens, Laboratoire d'anatomie pathologique, Lens, France.""}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Tavernier', 'Affiliation': 'CH Lens, Service de pneumologie, Lens, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Quintin', 'Affiliation': ""CHU Brest, Hôpital Morvan, Service d'anatomie pathologique, Brest, France.""}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Quiot', 'Affiliation': 'CHU Brest, Hôpital Morvan, Service de pneumologie, Brest, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Galateau-Sallé', 'Affiliation': ""CHU de Caen, Laboratoire d'anatomie pathologique, Caen, France.""}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Zalcman', 'Affiliation': 'CHU de Caen, Service de pneumologie, Caen, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Piton', 'Affiliation': 'Normandie Univ, UNIROUEN, Inserm U1245, CHU Rouen, Service de Pathologie, Rouen, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Thiberville', 'Affiliation': 'Normandie Univ, UNIROUEN, LITIS Lab QuantIF team EA4108, CHU Rouen, Department of Pneumology and Inserm CIC-CRB 1404, Rouen, France.'}]",The European respiratory journal,['10.1183/13993003.01946-2021']
3140,35237860,Cost-Effectiveness of Drug-Coated Balloon Angioplasty Versus Conventional Balloon Angioplasty for Treating Below-the-Knee Arteries in Chronic Limb-Threatening Ischemia: The SINGA-PACLI Trial.,"PURPOSE


Drug-coated balloon angioplasty (DCBA) has been studied as a potentially superior option compared to conventional percutaneous transluminal angioplasty (PTA) in treating below-the-knee (BTK) arteries in chronic limb-threatening ischemia (CLTI). The aim of this study is to examine the cost-effectiveness of DCBA versus PTA in BTK arteries based on a randomized controlled trial.
MATERIAL AND METHODS


A prospective economic study was embedded in a randomized controlled trial of 138 patients with CLTI. Resource use and health outcomes were assessed at baseline, and at 3, 6 and 12 months post-intervention. Costs were calculated from a societal perspective and health outcomes measured using quality-adjusted life years with probabilistic sensitivity analysis performed to account for subject heterogeneity.
RESULTS


Compared with participants randomized to receive PTA, participants randomized to DCBA gained an average baseline-adjusted quality-adjusted life years (QALYs) of .012 while average total costs were USD$1854 higher; this translates to an incremental cost-effectiveness ratio (ICER) of US$154,500 additional cost per QALY gained. However, the estimate of ICER had substantial variance with only 48% of bootstrap ICERs meeting a benchmark threshold of US$57,705 (the average gross domestic product (GDP) per capita of Singapore).
CONCLUSION


The use of DCBA in BTK arteries in CLTI patients was not cost-effective compared with PTA.
LEVEL OF EVIDENCE


2, Randomized trial.",2022,"Compared with participants randomized to receive PTA, participants randomized to DCBA gained an average baseline-adjusted quality-adjusted life years (QALYs) of .012 while average total costs were USD$1854 higher; this translates to an incremental cost-effectiveness ratio (ICER) of US$154,500 additional cost per QALY gained.","['138 patients with CLTI', 'Chronic Limb-Threatening Ischemia']","['Conventional Balloon Angioplasty', 'DCBA versus PTA', 'conventional percutaneous transluminal angioplasty (PTA', 'PTA', 'Drug-Coated Balloon Angioplasty', 'Drug-coated balloon angioplasty (DCBA', 'DCBA']","['incremental cost-effectiveness ratio (ICER) of US$154,500 additional cost per QALY gained', 'Resource use and health outcomes', 'Cost-Effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",138.0,0.0747552,"Compared with participants randomized to receive PTA, participants randomized to DCBA gained an average baseline-adjusted quality-adjusted life years (QALYs) of .012 while average total costs were USD$1854 higher; this translates to an incremental cost-effectiveness ratio (ICER) of US$154,500 additional cost per QALY gained.","[{'ForeName': 'Nirmali', 'Initials': 'N', 'LastName': 'Sivapragasam', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore. nirmali@duke-nus.edu.sg.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Matchar', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Kun Da', 'Initials': 'KD', 'LastName': 'Zhuang', 'Affiliation': 'Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Uei', 'Initials': 'U', 'LastName': 'Pua', 'Affiliation': 'Department of Diagnostic Radiology, Tan Tock Seng Hospital, 11 Jln Tan Tock Seng, Singapore, 308433, Singapore.'}, {'ForeName': 'Hlaing Hlaing', 'Initials': 'HH', 'LastName': 'Win', 'Affiliation': 'Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Sivanathan', 'Initials': 'S', 'LastName': 'Chandramohan', 'Affiliation': 'Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Nanda', 'Initials': 'N', 'LastName': 'Venkatanarasimha', 'Affiliation': 'Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Jasmine M E', 'Initials': 'JME', 'LastName': 'Chua', 'Affiliation': 'Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Glenn Wei Leong', 'Initials': 'GWL', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Tan Tock Seng Hospital, 11 Jln Tan Tock Seng, Singapore, 308433, Singapore.'}, {'ForeName': 'Farah G', 'Initials': 'FG', 'LastName': 'Irani', 'Affiliation': 'Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Sum', 'Initials': 'S', 'LastName': 'Leong', 'Affiliation': 'Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Kiang Hiong', 'Initials': 'KH', 'LastName': 'Tay', 'Affiliation': 'Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Tze Tec', 'Initials': 'TT', 'LastName': 'Chong', 'Affiliation': 'Department of Vascular Surgery, Division of Surgery and Surgical Oncology, Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Bien Soo', 'Initials': 'BS', 'LastName': 'Tan', 'Affiliation': 'Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-022-03073-7']
3141,35237844,Evaluation of an Electronic Health Record Alert to Improve Screening and Management of Cardiovascular Disease and Stroke Factors in a High-Risk Population.,"OBJECTIVES


Cardiovascular disease and stroke risk factor screening and management by primary care providers (PCPs) have a significant impact on their patients' health. The objective of this study was to investigate the effectiveness of an electronic health record (EHR) cardiovascular disease and stroke risk alert in improving the ability of PCPs to manage risk factors among women and men aged 45 years and older.
METHODS


PCPs at a tertiary care hospital were randomized. The intervention group received an EHR alert, which calculated the individual patient risk and provided an order set incorporating the American Heart Association and American Stroke Association guidelines, whereas the control group used the EHR in the usual manner. Multilevel analysis compared the rate of prescriptions between the intervention and control groups.
RESULTS


A total of 23 PCPs were randomized: 12 in the intervention group and 11 in the control group, attending to 7190 patients between September 2016 and January 2017. None of the providers in the intervention group used the programmed order set. Intervention group providers were significantly more likely to prescribe smoking cessation medication to women than to the control group (adjusted odds ratio 2.37, 95% confidence interval 1.23-4.57). There were no statistically significant differences between the intervention and control groups in the rate of other medication prescriptions.
CONCLUSIONS


As measured by prescriptions for medications, other than those for smoking cessation, the EHR alert was not shown to be successful in increasing the management of high-risk patients. Physicians receiving numerous messages in the EHR may experience alert desensitization.",2022,"Intervention group providers were significantly more likely to prescribe smoking cessation medication to women than to the control group (adjusted odds ratio 2.37, 95% confidence interval 1.23-4.57).","['PCPs at a tertiary care hospital were randomized', 'women and men aged 45 years and older', 'A total of 23 PCPs were randomized: 12 in the intervention group and 11 in the control group, attending to 7190 patients between September 2016 and January 2017']","['EHR alert, which calculated the individual patient risk and provided an order set incorporating the American Heart Association and American Stroke Association guidelines']","['prescribe smoking cessation medication', 'rate of other medication prescriptions']","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033081', 'cui_str': 'Drug prescription'}]",7190.0,0.0218164,"Intervention group providers were significantly more likely to prescribe smoking cessation medication to women than to the control group (adjusted odds ratio 2.37, 95% confidence interval 1.23-4.57).","[{'ForeName': 'Warren L', 'Initials': 'WL', 'LastName': 'Felton', 'Affiliation': ""From the Departments of Neurology, Psychiatry, Family Medicine and Population Health, and Internal Medicine, School of Medicine, and Institute for Women's Health, Virginia Commonwealth University, Richmond.""}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Kornstein', 'Affiliation': ""From the Departments of Neurology, Psychiatry, Family Medicine and Population Health, and Internal Medicine, School of Medicine, and Institute for Women's Health, Virginia Commonwealth University, Richmond.""}, {'ForeName': 'Tamala', 'Initials': 'T', 'LastName': 'Gondwe', 'Affiliation': ""From the Departments of Neurology, Psychiatry, Family Medicine and Population Health, and Internal Medicine, School of Medicine, and Institute for Women's Health, Virginia Commonwealth University, Richmond.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Huynh', 'Affiliation': ""From the Departments of Neurology, Psychiatry, Family Medicine and Population Health, and Internal Medicine, School of Medicine, and Institute for Women's Health, Virginia Commonwealth University, Richmond.""}, {'ForeName': 'Jordyn T', 'Initials': 'JT', 'LastName': 'Wallenborn', 'Affiliation': ""From the Departments of Neurology, Psychiatry, Family Medicine and Population Health, and Internal Medicine, School of Medicine, and Institute for Women's Health, Virginia Commonwealth University, Richmond.""}, {'ForeName': 'Jeneane', 'Initials': 'J', 'LastName': 'Henry', 'Affiliation': ""From the Departments of Neurology, Psychiatry, Family Medicine and Population Health, and Internal Medicine, School of Medicine, and Institute for Women's Health, Virginia Commonwealth University, Richmond.""}]",Southern medical journal,['10.14423/SMJ.0000000000001355']
3142,35237788,Hydrosurgical and conventional debridement of burns: randomized clinical trial.,"BACKGROUND


Tangential excision of burned tissue followed by skin grafting is the cornerstone of burn surgery. Hydrosurgery has become popular for tangential excision, with the hypothesis that enhanced preservation of vital dermal tissue reduces scarring. The aim of this trial was to compare scar quality after hydrosurgical versus conventional debridement before split-skin grafting.
METHODS


A double-blind randomized within-patient multicentre controlled trial was conducted in patients with burns that required split-skin grafting. One wound area was randomized to hydrosurgical debridement and the other to Weck knife debridement. The primary outcome was scar quality at 12 months, assessed with the observer part of the Patient and Observer Scar Assessment Scale (POSAS). Secondary outcomes included complications, scar quality, colour, pliability, and histological dermal preservation.
RESULTS


Some 137 patients were randomized. At 12 months, scars of the hydrosurgical debrided wounds had a lower POSAS observer total item score (mean 2.42 (95 per cent c.i. 2.26 to 2.59) versus 2.54 (95 per cent c.i. 2.36 to 2.72; P = 0.023)) and overall opinion score (mean 3.08 (95 per cent c.i. 2.88 to 3.28) versus 3.30 (95 per cent c.i. 3.09-3.51); P = 0.006). Patient-reported scar quality and pliability measurements were significantly better for the hydrosurgically debrided wounds. Complication rates did not differ between both treatments. Histologically, significantly more dermis was preserved with hydrosurgery (P < 0.001).
CONCLUSION


One year after surgery scar quality and pliability was better for hydrosurgically debrided burns, probably owing to enhanced histological preservation of dermis.
REGISTRATION NUMBER


Trial NL6085 (NTR6232 (http://www.trialregister.nl)).",2022,"Histologically, significantly more dermis was preserved with hydrosurgery (P < 0.001).
","['patients with burns that required split-skin grafting', '137 patients were randomized']","['hydrosurgical versus conventional debridement before split-skin grafting', 'skin grafting', 'Hydrosurgical and conventional debridement', 'hydrosurgical debridement and the other to Weck knife debridement']","['POSAS observer total item score', 'scar quality and pliability measurements', 'observer part of the Patient and Observer Scar Assessment Scale (POSAS', 'overall opinion score', 'scar quality', 'complications, scar quality, colour, pliability, and histological dermal preservation', 'Complication rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0037297', 'cui_str': 'Grafting to skin'}, {'cui': 'C4517569', 'cui_str': '137'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0037297', 'cui_str': 'Grafting to skin'}, {'cui': 'C0181467', 'cui_str': 'Knife'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]",137.0,0.564537,"Histologically, significantly more dermis was preserved with hydrosurgery (P < 0.001).
","[{'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Legemate', 'Affiliation': 'Burn Centre, Maasstad Hospital, 3079 DZ Rotterdam, The Netherlands.'}, {'ForeName': 'Kelly A A', 'Initials': 'KAA', 'LastName': 'Kwa', 'Affiliation': 'Burn Centre, Red Cross Hospital, 1942 LE Beverwijk, The Netherlands.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Goei', 'Affiliation': 'Burn Centre, Maasstad Hospital, 3079 DZ Rotterdam, The Netherlands.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Pijpe', 'Affiliation': 'Burn Centre, Red Cross Hospital, 1942 LE Beverwijk, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Middelkoop', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Amsterdam UMC, Amsterdam Movement Sciences, Vrije Univeristeit Amsterdam, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Paul P M', 'Initials': 'PPM', 'LastName': 'van Zuijlen', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Amsterdam UMC, Amsterdam Movement Sciences, Vrije Univeristeit Amsterdam, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Gerard I J M', 'Initials': 'GIJM', 'LastName': 'Beerthuizen', 'Affiliation': 'Burn Centre, Martini Hospital, 9728 NT Groningen, The Netherlands.'}, {'ForeName': 'Marianne K', 'Initials': 'MK', 'LastName': 'Nieuwenhuis', 'Affiliation': 'Association of Dutch Burn Centres, Martini Hospital, 9728 NT Groningen, The Netherlands.'}, {'ForeName': 'Margriet E', 'Initials': 'ME', 'LastName': 'van Baar', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Centre Rotterdam, 3015 GD Rotterdam, The Netherlands.'}, {'ForeName': 'Cornelis H', 'Initials': 'CH', 'LastName': 'van der Vlies', 'Affiliation': 'Burn Centre, Maasstad Hospital, 3079 DZ Rotterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of surgery,['10.1093/bjs/znab470']
3143,35237755,Clindamycin adjunctive therapy for severe  Staphylococcus aureus  treatment evaluation (CASSETTE)-an open-labelled pilot randomized controlled trial.,"Background


Combination antibiotic therapy with an antitoxin agent, such as clindamycin, is included in some guidelines for severe, toxin-mediated  Staphylococcus aureus  infections. The evidence to support this practice is currently limited to  in vitro,  animal and observational human case-series data, with no previous randomized controlled trials (RCTs).
Objectives


This pilot RCT aimed to determine the feasibility of conducting a clinical trial to examine if adjunctive clindamycin with standard therapy has greater efficacy than standard therapy alone for  S. aureus  infections.
Methods


We performed an investigator-initiated, open-label, multicentre, pilot RCT (ACTRN12617001416381p) in adults and children with severe  S. aureus  infections, randomized to standard antibiotic therapy with or without clindamycin for 7 days.
Results


Over 28 months, across nine sites, 127 individuals were screened and 34 randomized, including 11 children (32%). The primary outcome-number of days alive and free of systemic inflammatory response syndrome ≤14 days-was similar between groups: clindamycin (3 days [IQR 1-6]) versus standard therapy (4 days [IQR 0-8]). The 90 day mortality was 0% (0/17) in the clindamycin group versus 24% (4/17) in the standard therapy group. Secondary outcomes-microbiological relapse, treatment failure or diarrhoea-were similar between groups.
Conclusions


As the first clinical trial assessing adjunctive clindamycin for  S. aureus  infections, this study indicates feasibility and that adults and children can be incorporated into one trial using harmonized endpoints, and there were no safety concerns. The CASSETTE trial will inform the definitive  S. aureus  Network Adaptive Platform (SNAP) trial, which includes an adjunctive clindamycin domain and participants with non-severe disease.",2022,The primary outcome-number of days alive and free of systemic inflammatory response syndrome ≤14 days-was similar between groups: clindamycin (3 days [IQR 1-6]) versus standard therapy (4 days [IQR 0-8]).,"['and participants with non-severe disease', 'adults and children with severe  S. aureus  infections', '127 individuals were screened and 34 randomized, including 11 children (32']","['standard antibiotic therapy with or without clindamycin', 'clindamycin', 'Clindamycin adjunctive therapy', 'clindamycin domain']","['microbiological relapse, treatment failure or diarrhoea', 'number of days alive and free of systemic inflammatory response syndrome ≤14\u2005days']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}]",127.0,0.264368,The primary outcome-number of days alive and free of systemic inflammatory response syndrome ≤14 days-was similar between groups: clindamycin (3 days [IQR 1-6]) versus standard therapy (4 days [IQR 0-8]).,"[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Campbell', 'Affiliation': ""Department of Infectious Diseases, Perth Children's Hospital, Perth, Australia.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dotel', 'Affiliation': 'Department of Infectious Diseases, Blacktown Hospital, Sydney, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Braddick', 'Affiliation': 'Department of Infectious Diseases, Townsville University Hospital, Townsville, Queensland, Australia.'}, {'ForeName': 'P N', 'Initials': 'PN', 'LastName': 'Britton', 'Affiliation': ""Department of Infectious Diseases and Microbiology, Children's Hospital Westmead, Sydney, Australia.""}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Eisen', 'Affiliation': 'College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Francis', 'Affiliation': 'Global and Tropical Health Division, Menzies School of Health Research, Darwin, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lynar', 'Affiliation': 'Global and Tropical Health Division, Menzies School of Health Research, Darwin, Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'McMullan', 'Affiliation': ""Department of Immunology and Infectious Diseases, Sydney Children's Hospital, Randwick, Sydney, Australia.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Meagher', 'Affiliation': 'Department of Infectious Diseases, Doherty Institute for Infection & Immunity, The University of Melbourne & Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'Global and Tropical Health Division, Menzies School of Health Research, Darwin, Australia.'}, {'ForeName': 'M V N', 'Initials': 'MVN', 'LastName': ""O'Sullivan"", 'Affiliation': 'Centre for Infectious Diseases and Microbiology, Westmead Hospital, University of Sydney, Sydney, Australia.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Price', 'Affiliation': 'Department of Infectious Diseases, Doherty Institute for Infection & Immunity, The University of Melbourne & Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Robinson', 'Affiliation': 'Department of Infectious Diseases, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Whelan', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Australia.'}, {'ForeName': 'S Y C', 'Initials': 'SYC', 'LastName': 'Tong', 'Affiliation': 'Department of Infectious Diseases, Doherty Institute for Infection & Immunity, The University of Melbourne & Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Bowen', 'Affiliation': ""Department of Infectious Diseases, Perth Children's Hospital, Perth, Australia.""}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Davis', 'Affiliation': 'Global and Tropical Health Division, Menzies School of Health Research, Darwin, Australia.'}]",JAC-antimicrobial resistance,['10.1093/jacamr/dlac014']
3144,35238305,"Effects of Melatonin for Delirium in Elderly Acute Heart Failure Patients: A Randomized, Single-Center, Double-Blind, and Placebo-Controlled Trial.","BACKGROUND


Delirium is a common, life-threatening, typical clinical syndrome with the main clinical manifestations of temporary organic mental disorder without specific drug treatment. The aim of the study was to explore the benefits of melatonin for the treatment of delirium after acute heart failure in elderly patients.
METHODS


This was a randomized, double-blind, and placebo-controlled trial. This study enrolled patients aged more than 60 years after acute heart failure. A computer-generated randomization sequence (in a 1:1 ratio) was used to randomly assign patients to receive either melatonin (3 mg/day, 7 days) or placebos. The primary endpoint was the incidence of delirium, assessed twice daily with the Confusion Assessment Method during the first 7 days. Analyses were performed by intention-to-treat and safety populations.
RESULTS


Between October 2015 and October 2019, 584 patients were assessed. A total of 497 patients randomly were assigned to receive either placebo (N = 249) or melatonin (N = 248). The incidence of delirium was significantly lower in the melatonin group than in the placebo group (27.0% vs. 36.9%, P = 0.021). Regarding safety, the occurrence of rhabdomyolysis and abnormal hepatic function did not differ between the two groups.
CONCLUSION


The current study (clinical trial registered number: CHWX-904-201511) suggests that acute melatonin treatment can reduce the incidence of delirium for elderly acute heart failure. It also can reduce the time of hospital stays and hospitalization costs. The therapy was safe and worth spreading.",2022,"The incidence of delirium was significantly lower in the melatonin group than in the placebo group (27.0% vs. 36.9%, P = 0.021).","['enrolled patients aged more than 60 years after acute heart failure', 'elderly acute heart failure', '497 patients randomly', 'elderly patients', '584 patients were assessed', 'Between October 2015 and October 2019', 'Elderly Acute Heart Failure Patients']","['melatonin', 'placebo', 'Melatonin', 'Placebo', 'placebos']","['occurrence of rhabdomyolysis and abnormal hepatic function', 'time of hospital stays and hospitalization costs', 'incidence of delirium', 'incidence of delirium, assessed twice daily with the Confusion Assessment Method']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0035410', 'cui_str': 'Rhabdomyolysis'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",497.0,0.863992,"The incidence of delirium was significantly lower in the melatonin group than in the placebo group (27.0% vs. 36.9%, P = 0.021).","[{'ForeName': 'Bi', 'Initials': 'B', 'LastName': 'Yin', 'Affiliation': 'Department of Cardiology, Wuxi Clinical Medical School of Anhui Medical University, 904th Hospital of PLA, Wuxi, China. yingbi904@163.com.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Ye', 'Affiliation': 'Department of Cardiology, Wuxi Clinical Medical School of Anhui Medical University, 904th Hospital of PLA, Wuxi, China. 753126294@qq.com.'}, {'ForeName': 'Xinxia', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Wuxi Clinical Medical School of Anhui Medical University, 904th Hospital of PLA, Wuxi, China. 557326217@qq.com.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wan', 'Affiliation': 'Department of Cardiology, Wuxi Clinical Medical School of Anhui Medical University, 904th Hospital of PLA, Wuxi, China. 995476331@qq.com.'}, {'ForeName': 'Lilei', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': 'Department of Cardiology, Wuxi Clinical Medical School of Anhui Medical University, 904th Hospital of PLA, Wuxi, China. 176233764@qq.com.'}, {'ForeName': 'Gangjun', 'Initials': 'G', 'LastName': 'Zong', 'Affiliation': 'Department of Cardiology, Wuxi Clinical Medical School of Anhui Medical University, 904th Hospital of PLA, Wuxi, China. 3552601959@qq.com.'}]",The heart surgery forum,['10.1532/hsf.4325']
3145,35238296,The Simple Technique of Sternal Closure Using An Absorbable Mesh Plate.,"BACKGROUND


Several authors have investigated various sternal closure materials and technologies for sternal fixation; nonetheless, the optimal technique for primary sternal closure remains unclear. This study aimed to evaluate the sternal stability of a simple technique using a mesh-type plate (Super Fixorb MX40®; Takiron Co. Ltd., Osaka, Japan), as compared with wire cerclage.
METHODS


A total of 70 patients who underwent cardiovascular surgery through median sternotomy between July 2019 and May 2020 were included. Two pieces of mesh-type plates were placed under the sternum in combination with wiring. The technique for sternal closure was randomly applied, which was mainly based on the surgeon's preferences: mesh plate (mesh group: N = 33) or conventional wire cerclage (wire group: N = 37). Sternal displacement was measured using computed tomography at discharge.
RESULTS


Pain scale scores and analgesic use on postoperative day 7 were similar between the two groups. However, the displacement in both the anterior-posterior and lateral directions was significantly smaller in the mesh group.
CONCLUSIONS


The use of the mesh plate device for sternal closure is simple, safe, easy, and potentially reliable without anterior-posterior sternal displacement.",2022,"The use of the mesh plate device for sternal closure is simple, safe, easy, and potentially reliable without anterior-posterior sternal displacement.",['70 patients who underwent cardiovascular surgery through median sternotomy between July 2019 and May 2020 were included'],"['Sternal Closure Using An Absorbable Mesh Plate', 'conventional wire cerclage']","['Pain scale scores', 'sternal stability', 'Sternal displacement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C1292825', 'cui_str': 'Cerclage'}]","[{'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",70.0,0.0479718,"The use of the mesh plate device for sternal closure is simple, safe, easy, and potentially reliable without anterior-posterior sternal displacement.","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watanuki', 'Affiliation': 'Department of Cardiac Surgery, Aichi Medical University Hospital Yazakokarimata, Nagakute, Aichi, Japan. hwatanuk@aichi-med-u.ac.jp.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Futamura', 'Affiliation': 'Department of Cardiac Surgery, Aichi Medical University Hospital Yazakokarimata, Nagakute, Aichi, Japan. futacoco@aichi-med-u.ac.jp.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Tochii', 'Affiliation': 'Department of Cardiac Surgery, Aichi Medical University Hospital Yazakokarimata, Nagakute, Aichi, Japan. masatochii@yahoo.co.jp.'}, {'ForeName': 'Kayo', 'Initials': 'K', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Cardiac Surgery, Aichi Medical University Hospital Yazakokarimata, Nagakute, Aichi, Japan. kayotaro3@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Katsuhiko Matsuyama', 'Affiliation': 'Department of Cardiac Surgery, Aichi Medical University Hospital Yazakokarimata, Nagakute, Aichi, Japan. spgfs112@yahoo.co.jp.'}]",The heart surgery forum,['10.1532/hsf.4443']
3146,35238225,Improvement of vitamin D status through consumption of either fortified food products or supplement pills increased hemoglobin concentration in adult subjects: Analysis of pooled data from two randomized clinical trials.,"Background:  It is documented that vitamin D may have a role in erythropoiesis as its deficiency is accompanied by an increased risk of anemia.  Aim:  This study aimed to examine whether improvement of vitamin D status through daily consumption of either fortified foods or supplements could impinge on certain hematologic parameters in adults.  Methods:  We pooled data from our two separate clinical trials and made five experimental groups. As part of their usual diet, one group consumed 500 mL/day of yogurt drink fortified with 1000 IU of vitamin D (D-yogurt,  n  = 27) whereas one group consumed 500 mL/day of the plain yogurt drink (P-yogurt,  n  = 27). In addition three other groups consumed either 50 g/day bread fortified with 1000 IU of vitamin D (D-bread) or supplement containing 1000 IU vitamin D (D-supplement,  n  = 27) or placebo (placebo,  n  = 27). Biochemical measurements were performed before and after the intervention.  Results:  In all three vitamin D-supplemented groups, serum 25(OH)D concentration increased after the intervention period, which was interestingly accompanied by a significant increment of hemoglobin (D-yogurt,  p  < 0.001, D-bread,  p  = 0.003, D-supplement,  p  < 0.001). Analyses indicated that among participants in vitamin D-intervention groups, being in D-yogurt group was more favourable predictor of improvement in hemoglobin concentrations compared with the placebo ( p  < 0.001), D-bread ( p  = 0.045) and P-yogurt ( p  = 0.001).  Conclusion:  Improvement of vitamin D status via regular intake of either vitamin D-fortified food products or supplements can result in a significant increment of hemoglobin in adult subjects. This finding has very important clinical as well as public health implications.",2022,"In all three vitamin D-supplemented groups, serum 25(OH)D concentration increased after the intervention period, which was interestingly accompanied by a significant increment of hemoglobin (D-yogurt,  p  < 0.001, D-bread,  p  = 0.003, D-supplement,  p  < 0.001).","['adults', 'adult subjects']","['vitamin D (D-bread) or supplement containing 1000 IU vitamin D (D-supplement,  n \u2009=\u200927) or placebo (placebo', 'yogurt drink fortified with 1000 IU of vitamin D (D-yogurt,  n \u2009=\u200927) whereas one group consumed 500\u2005mL/day of the plain yogurt drink', 'vitamin D', 'placebo']","['hemoglobin concentrations', 'serum 25(OH)D concentration', 'hemoglobin concentration', 'hemoglobin', 'certain hematologic parameters']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439446', 'cui_str': 'mL/24h'}]","[{'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.275041,"In all three vitamin D-supplemented groups, serum 25(OH)D concentration increased after the intervention period, which was interestingly accompanied by a significant increment of hemoglobin (D-yogurt,  p  < 0.001, D-bread,  p  = 0.003, D-supplement,  p  < 0.001).","[{'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Nikooyeh', 'Affiliation': 'Laboratory of Nutrition Research, 226734National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Zahedirad', 'Affiliation': 'Laboratory of Nutrition Research, 226734National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Kalayi', 'Affiliation': 'Laboratory of Nutrition Research, 226734National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Shariatzadeh', 'Affiliation': 'Laboratory of Nutrition Research, 226734National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, 2345Medical University of South Carolina, Charleston, SC, 29425, United States.'}, {'ForeName': 'Tirang R', 'Initials': 'TR', 'LastName': 'Neyestani', 'Affiliation': 'Laboratory of Nutrition Research, 226734National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Nutrition and health,['10.1177/02601060221085351']
3147,35238218,Streamlined versus traditional consent for low-risk comparative effectiveness trials: a randomized experimental study to measure patients' and public attitudes.,"Aim:  Streamlining consent for low-risk comparative effectiveness research (CER) could facilitate research, while safeguarding patients' rights.  Materials & methods:  2618 adults were randomized to one of seven consent approaches (six streamlined and one traditional) for a hypothetical, low-risk CER study. A survey measured understanding, voluntariness, and feelings of respect.  Results:  Participants in all arms had a high understanding of the trial and positive attitudes toward the consent interaction. Highest satisfaction was with a streamlined approach showing a video before the medical appointment. Participants in streamlined were more likely to mistakenly think a signature was required.  Conclusion:  Streamlined consent was no less acceptable than traditional, signed consent. Streamlined and traditional approaches achieved similar levels of understanding, voluntariness and a feeling that the doctor-patient interaction was respectful.",2022,"Streamlined and traditional approaches achieved similar levels of understanding, voluntariness and a feeling that the doctor-patient interaction was respectful.","[""patients' and public attitudes"", '2618 adults']","['Streamlined versus traditional consent', 'Streamlined consent']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]",[],2618.0,0.0462687,"Streamlined and traditional approaches achieved similar levels of understanding, voluntariness and a feeling that the doctor-patient interaction was respectful.","[{'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Kass', 'Affiliation': 'Johns Hopkins Berman Institute of Bioethics, Baltimore, MD 21205, USA.'}, {'ForeName': 'Ruth R', 'Initials': 'RR', 'LastName': 'Faden', 'Affiliation': 'Johns Hopkins Berman Institute of Bioethics, Baltimore, MD 21205, USA.'}, {'ForeName': 'Stephanie R', 'Initials': 'SR', 'LastName': 'Morain', 'Affiliation': 'Johns Hopkins Berman Institute of Bioethics, Baltimore, MD 21205, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Hallez', 'Affiliation': 'Center for Effective Global Action, University of California, Berkeley.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Stametz', 'Affiliation': 'Steele Institute for Health Innovation, Geisinger, Danville, PA 17822, USA.'}, {'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Milo', 'Affiliation': 'Steele Institute for Health Innovation, Geisinger, Danville, PA 17822, USA.'}, {'ForeName': 'Deserae', 'Initials': 'D', 'LastName': 'Clarke', 'Affiliation': 'University of Arizona College of Medicine - Phoenix, Division of Clinical Data Analytics & Decision Support, Phoenix, AZ 85004, USA.'}]",Journal of comparative effectiveness research,['10.2217/cer-2021-0173']
3148,35238694,Real-time auditory feedback may reduce abnormal movements in patients with chronic stroke.,"PURPOSE


The current pilot study assesses the use of real-time auditory feedback to help reduce abnormal movements during an active reaching task in patients with chronic stroke.
MATERIALS AND METHODS


20 patients with chronic stroke completed the study with full datasets (age:  M  = 53  SD  = 14; sex: male = 75%; time since stroke in months:  M  = 34,  SD  = 33). Patients undertook 100 repetitions of an active reaching task while listening to self-selected music which automatically muted when abnormal movement was detected, determined by thresholds set by clinical therapists. A within-subject design with two conditions (with auditory feedback vs. without auditory feedback) presented in a randomised counterbalanced order was used. The dependent variable was the duration of abnormal movement as a proportion of trial duration.
RESULTS


A significant reduction in the duration of abnormal movement was observed when patients received auditory feedback, F(1,18) = 9.424,  p  = 0.007, with a large effect size (partial  η 2  = 0.344).
CONCLUSIONS


Patients with chronic stroke can make use of real-time auditory feedback to increase the proportion of time they spend in optimal movement patterns. The approach provides a motivating framework that encourages high dose with a key focus on quality of movement.  Trial Registration:  ISRCTN12969079 https://www.isrctn.com/ISRCTN12969079  ISRTCN trial registration REF:  ISRCTN12969079IMPLICATIONS FOR REHABILITATIONMovement quality during upper limb rehabilitation should be targeted as part of a well-balanced rehabilitation programme.Auditory feedback is a useful tool to help patients with chronic stroke reduce compensatory movements.",2022,"A significant reduction in the duration of abnormal movement was observed when patients received auditory feedback, F(1,18) =","['patients with chronic stroke', '20 patients with chronic stroke completed the study with full datasets (age:  M \u2009=\u200953  SD \u2009=\u200914; sex: male = 75%; time since stroke in months:  M \u2009=\u200934,  SD \u2009=\u200933', 'Patients with chronic stroke', 'patients with chronic stroke reduce compensatory movements']","['real-time auditory feedback', 'Real-time auditory feedback', 'auditory feedback vs. without auditory feedback', 'Auditory feedback', 'active reaching task while listening to self-selected music']",['duration of abnormal movement'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]",20.0,0.0704657,"A significant reduction in the duration of abnormal movement was observed when patients received auditory feedback, F(1,18) =","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Douglass-Kirk', 'Affiliation': 'Department of Psychology, Goldsmiths University of London, London, UK.'}, {'ForeName': 'Mick', 'Initials': 'M', 'LastName': 'Grierson', 'Affiliation': 'University of the Arts London, UAL Creative Computing Institute, London, UK.'}, {'ForeName': 'Nick S', 'Initials': 'NS', 'LastName': 'Ward', 'Affiliation': 'Department of clinical and Motor Neuroscience, UCL Queen Square Institute of Neurology.'}, {'ForeName': 'Fran', 'Initials': 'F', 'LastName': 'Brander', 'Affiliation': 'National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Chegwidden', 'Affiliation': 'Royal Free London NHS Foundation Trust, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Dhiren', 'Initials': 'D', 'LastName': 'Shivji', 'Affiliation': 'National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Stewart', 'Affiliation': 'Department of Psychology, Goldsmiths University of London, London, UK.'}]",Disability and rehabilitation,['10.1080/09638288.2022.2037751']
3149,35237159,"Yunpi Qufeng Chushi Formula for Pre-Rheumatoid Arthritis: Study Protocol for a Multiple-Center, Double-Blind, Placebo-Controlled Randomized Controlled Trial.","Introduction:  Rheumatoid arthritis (RA) is an autoimmune disease characterized by progressive bone erosion on diarthrodial joints. RA patients usually experienced three stages before final diagnosis: the health period, the pre-clinical period (immune response exists without clinical symptoms), and the pre-RA period (immune response exists with mild inflammatory manifestation). Presently, there is seldom guidance referring to early intervention which is a benefit for stable disease conditions and low morbidity. Prophylactic treatment is a major feature of traditional Chinese medicine (TCM). In this present study, a multi-center, double-blind, placebo-controlled clinical trial is carried out to evaluate both efficacy and safety in preventing RA progression on Yunpi Qufeng Chushi formula (YQCF).  Method:  The multi-center, double-blind, placebo-controlled clinical trial is conducted in 13 hospitals nationwide. A total of 390 patients ages between 18 and 70 will be recruited in the trial. They will be randomly assigned to the intervention group (YQCF) and placebo group. The follow-up visit will be taken every 3 months from baseline to 1 year. Diagnosis, disease activity scores, clinical disease activity index (CDAI), simplified disease activity index (SDAI), TCM syndrome scores, and safety assessments will be recorded at every visit. Joint color doppler ultrasound, health assessment questionnaire-disability index (HAQ-DI), and functional assessment of chronic illness therapy-fatigue (FACIT-F) will be recorded at baseline and the last visit.  Discussion:  This work will provide evidence of YQCF in preventing RA progression. However, whether early intervention would benefit the controlling RA disease still needs a long-term follow-up.  Ethics and dissemination:  Protocol version 2 (201910-1). This research was approved by the medical ethics committee of Zhejiang Chinese Medical University (2019-045). Results will be published in a peer-reviewed academic journal.  Trial registration numbers:  http://www.chictr.org.cn/index.aspx, ChiCTR1900024166.",2022,"Joint color doppler ultrasound, health assessment questionnaire-disability index (HAQ-DI), and functional assessment of chronic illness therapy-fatigue (FACIT-F) will be recorded at baseline and the last visit.  ","['390 patients ages between 18 and 70 will be recruited in the trial', '13 hospitals nationwide', 'Zhejiang Chinese Medical University (2019-045', 'Pre-Rheumatoid Arthritis']","['Yunpi Qufeng Chushi Formula', 'YQCF', 'placebo', 'Placebo', 'intervention group (YQCF) and placebo']","['Diagnosis, disease activity scores, clinical disease activity index (CDAI), simplified disease activity index (SDAI), TCM syndrome scores, and safety assessments', 'Joint color doppler ultrasound, health assessment questionnaire-disability index (HAQ-DI), and functional assessment of chronic illness therapy-fatigue (FACIT-F']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0474781', 'cui_str': 'Color doppler ultrasound'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",390.0,0.513855,"Joint color doppler ultrasound, health assessment questionnaire-disability index (HAQ-DI), and functional assessment of chronic illness therapy-fatigue (FACIT-F) will be recorded at baseline and the last visit.  ","[{'ForeName': 'Yujun', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'College of Basic Medical Science, Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Haichang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'College of Basic Medical Science, Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'College of Basic Medical Science, Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'College of Basic Medical Science, Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Yongmei', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Rheumatology, Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Hangzhou, China.'}, {'ForeName': 'Huaxiang', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'The Second Affillated Hospital Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Division of Rheumatology, Dong Fang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Chuanbing', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China.'}, {'ForeName': 'Changsong', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Qingwen', 'Initials': 'Q', 'LastName': 'Tao', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jinyang', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Xiyuan Hospital of China Academy of Chinese Medicine Science, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'College of Basic Medical Science, Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Chengping', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': 'College of Basic Medical Science, Zhejiang Chinese Medical University, Hangzhou, China.'}]",Frontiers in pharmacology,['10.3389/fphar.2022.793394']
3150,35237066,Immune-Related lncRNA Pairs Clinical Prognosis Model Construction for Hepatocellular Carcinoma.,"Background


Long non-coding RNA (lncRNA) plays an essential regulatory role in the occurrence and development of hepatocellular carcinoma (HCC). This paper aims to establish an immune-related lncRNA (irlncRNA) pairs model independent of expression level for risk assessment and prognosis prediction of HCC.
Methods


Transcriptome data and corresponding clinical data were downloaded from TCGA. HCC patients were randomly divided into training group and test group. Univariate Cox regression analysis, LASSO regression analysis, and stepwise multiple Cox regression analysis were used to establish a prognostic model. The prediction ability of the model was verified by ROC curves. Next, the patients were divided into low-risk and high-risk groups. We compared the differences between the two groups in survival rate, clinicopathological characteristics, tumor immune cell infiltration status, chemotherapeutic drug sensitivity and immunosuppressive molecules.
Results


A prognosis prediction model was established based on 7 irlncRNA pairs, namely irlncRNA pairs (IRLP). ROC curves of the training group and test group showed that the IRLP model had high sensitivity and specificity for survival prediction. Kaplan-Meier analysis showed that the survival rate of the high-risk group was significantly lower than that of the low-risk group. Immune cell infiltration analysis showed that the high-risk group was significantly correlated with various immune cell infiltration. Finally, there were statistically significant differences in chemosensitivity and molecular marker expression between the two groups.
Conclusion


The prognosis prediction model established by irlncRNA pairs has a certain guiding significance for the prognosis prediction of HCC. It may provide valuable clinical applications in antitumor immunotherapy.",2022,ROC curves of the training group and test group showed that the IRLP model had high sensitivity and specificity for survival prediction.,"['Hepatocellular Carcinoma', 'HCC patients']",['\n\n\nLong non-coding RNA (lncRNA'],"['survival rate', 'chemosensitivity and molecular marker expression', 'ROC curves', 'survival rate, clinicopathological characteristics, tumor immune cell infiltration status, chemotherapeutic drug sensitivity and immunosuppressive molecules', 'sensitivity and specificity for survival prediction']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0237865', 'cui_str': 'Propensity to adverse reactions to drug'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",7.0,0.0384569,ROC curves of the training group and test group showed that the IRLP model had high sensitivity and specificity for survival prediction.,"[{'ForeName': 'Yinghui', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Digestology, The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, People's Republic of China.""}, {'ForeName': 'Dezhi', 'Initials': 'D', 'LastName': 'Shan', 'Affiliation': ""Graduate School of Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Lianyi', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': ""Department of Digestology, The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, People's Republic of China.""}, {'ForeName': 'Shujia', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Digestology, The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, People's Republic of China.""}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Digestology, The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, People's Republic of China.""}]",International journal of general medicine,['10.2147/IJGM.S343350']
3151,35237053,Efficacy and Safety of Ceftaroline Fosamil in Hospitalized Patients with Community-Acquired Pneumonia in China: Subset Analysis of an International Phase 3 Randomized Controlled Trial.,"Background


Ceftaroline fosamil has demonstrated superior clinical efficacy versus ceftriaxone for hospitalized adults with moderate-to-severe community-acquired pneumonia (CAP) in a Phase 3 trial in Asia and in a meta-analysis of three trials in Asia, North America, and Europe. Efficacy and safety outcomes for the subset of patients in China in the ASIA CAP trial were analyzed to determine if the same conclusions hold in the China subpopulation.
Methods


Hospitalized adults with Pneumonia Outcomes Research Team risk class III-IV CAP were randomized (1:1) to receive either intravenous ceftaroline fosamil 600 mg every 12 h or ceftriaxone 2 g every 24 h for 5-7 days. The primary efficacy variable was clinical response at test-of-cure (TOC) in the clinically evaluable (CE) population. Secondary endpoints included microbiological responses and safety.
Results


Of 302 patients randomized in China, 205 were included in the CE population. Clinical cure rates at TOC were 80/105 (76.2%) for ceftaroline fosamil and 61/100 (61.0%) for ceftriaxone (difference 15.2%, 95% CI 2.5, 27.6), thereby meeting predefined non-inferiority and superiority criteria for the overall study. Subgroup analyses of the primary endpoint demonstrated consistency of favourable efficacy of ceftaroline fosamil across age groups, Pneumonia Outcomes Research Team risk classes and CURB-65 scores. Microbiological responses were presumed from clinical outcomes. Adverse events were consistent with the study treatments' known safety profiles.
Conclusion


The China subset results are consistent with the overall study population, despite the smaller sample size. Ceftaroline fosamil was both non-inferior and superior to ceftriaxone for empiric treatment of Chinese patients with moderate-to-severe CAP.
Trial Registration


ClinicalTrials.gov identifier NCT01371838.",2022,"Clinical cure rates at TOC were 80/105 (76.2%) for ceftaroline fosamil and 61/100 (61.0%) for ceftriaxone (difference 15.2%, 95% CI 2.5, 27.6), thereby meeting predefined non-inferiority and superiority criteria for the overall study.","['Chinese patients with moderate-to-severe CAP', 'subset of patients in China in the ASIA CAP trial', 'hospitalized adults with moderate-to-severe community-acquired pneumonia (CAP) in a Phase 3 trial in Asia and in a meta-analysis of three trials in Asia, North America, and Europe', 'Hospitalized Patients with Community-Acquired Pneumonia in China', '302 patients randomized in China, 205 were included in the CE population', 'Hospitalized adults with Pneumonia Outcomes Research Team risk class III-IV CAP']","['ceftriaxone', 'intravenous ceftaroline fosamil 600 mg every 12 h or ceftriaxone', 'Ceftaroline Fosamil']","['consistency of favourable efficacy of ceftaroline fosamil across age groups, Pneumonia Outcomes Research Team risk classes and CURB-65 scores', 'clinical response at test-of-cure (TOC', 'Microbiological responses', 'Efficacy and Safety', 'Adverse events', 'microbiological responses and safety', 'Efficacy and safety outcomes', 'Clinical cure rates at TOC']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0282458', 'cui_str': 'Meta-Analysis'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}]","[{'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4060157', 'cui_str': 'ceftaroline fosamil 600 MG [Teflaro]'}, {'cui': 'C2001525', 'cui_str': 'ceftaroline fosamil'}]","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2001525', 'cui_str': 'ceftaroline fosamil'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",302.0,0.596309,"Clinical cure rates at TOC were 80/105 (76.2%) for ceftaroline fosamil and 61/100 (61.0%) for ceftriaxone (difference 15.2%, 95% CI 2.5, 27.6), thereby meeting predefined non-inferiority and superiority criteria for the overall study.","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhuo', 'Affiliation': ""State Key Laboratory of Respiratory Disease, National Clinical Research Center of Respiratory Diseases, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yijiang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Respiratory Clinical Medical Center, Hainan Cancer Hospital, Hainan, People's Republic of China.""}, {'ForeName': 'Wenyuan', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Respiratory Department, Sichuan Provincial People's Hospital, Chengdu, People's Republic of China.""}, {'ForeName': 'Jin-Fu', 'Initials': 'JF', 'LastName': 'Xu', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Wei Yun', 'Initials': 'WY', 'LastName': 'Zhu', 'Affiliation': ""Medical Department, Pfizer Investment Co. Ltd., Beijing, People's Republic of China.""}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Stone', 'Affiliation': 'Biopharmaceuticals Group, Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Jean Li', 'Initials': 'JL', 'LastName': 'Yan', 'Affiliation': 'Biopharmaceuticals Group, Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'Naglaa', 'Initials': 'N', 'LastName': 'Mohamed', 'Affiliation': 'Biopharmaceuticals Group, Pfizer Inc., New York, NY, USA.'}]",Infection and drug resistance,['10.2147/IDR.S342558']
3152,35237033,Respiratory Effects of Treatment with a Glucagon-Like Peptide-1 Receptor Agonist in Patients Suffering from Obesity and Chronic Obstructive Pulmonary Disease.,"Purpose


Chronic obstructive pulmonary disease (COPD) affects millions of people worldwide. Obesity is commonly seen concomitantly with COPD. People with COPD have reduced quality of life, reduced physical activity, chronic respiratory symptoms, and may suffer from frequent clinical exacerbations. Liraglutide is a glucagon-like peptide-1 receptor agonist (GLP-1RA) approved for weight loss and treatment of type-2 diabetes mellitus. In addition, liraglutide exerts anti-inflammatory actions by reducing IL-6 and MCP-1 levels. We investigated the effect of liraglutide on pulmonary function in people suffering from obesity and COPD.
Patients and Methods


In this controlled, double-blind trial, 40 people with obesity and COPD from two outpatient clinics were allocated randomly to receive liraglutide (3.0 mg, s.c.) or placebo (s.c.) for 40 weeks. At baseline and after 4, 20, 40, and 44 weeks, participants underwent pulmonary-function tests, 6-min walking test, and replied to a questionnaire regarding the clinical impact of COPD (COPD assessment test (CAT)-score).
Results


Compared with placebo, liraglutide use resulted in significant weight loss, increased forced vital capacity (FVC) and carbon monoxide diffusion capacity, and improved CAT-score. We found no significant changes in forced expiratory volume in one second (FEV 1 ), FEV 1 /FVC, or 6-min walking distance.
Conclusion


In patients suffering from obesity and COPD, 40 weeks of treatment with liraglutide improved some measures of pulmonary function. Our study suggests that liraglutide at 3.0 mg may be appropriate treatment in patients with obesity and COPD.",2022,"Compared with placebo, liraglutide use resulted in significant weight loss, increased forced vital capacity (FVC) and carbon monoxide diffusion capacity, and improved CAT-score.","['people suffering from obesity and COPD', 'Patients Suffering from Obesity and Chronic Obstructive Pulmonary Disease', 'patients with obesity and COPD', '40 people with obesity and COPD from two outpatient clinics']","['placebo, liraglutide', 'Glucagon-Like Peptide-1 Receptor Agonist', 'placebo', 'glucagon-like peptide-1 receptor agonist (GLP-1RA', 'Liraglutide', 'liraglutide']","['forced expiratory volume in one second (FEV 1 ), FEV 1 /FVC, or 6-min walking distance', 'weight loss, increased forced vital capacity (FVC) and carbon monoxide diffusion capacity, and improved CAT-score', 'IL-6 and MCP-1 levels', 'quality of life, reduced physical activity, chronic respiratory symptoms', 'clinical impact of COPD (COPD assessment test (CAT)-score', 'pulmonary function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C2960692', 'cui_str': 'Chronic obstructive pulmonary disease assessment test score'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",40.0,0.208675,"Compared with placebo, liraglutide use resulted in significant weight loss, increased forced vital capacity (FVC) and carbon monoxide diffusion capacity, and improved CAT-score.","[{'ForeName': 'Ayse Dudu', 'Initials': 'AD', 'LastName': 'Altintas Dogan', 'Affiliation': 'Department of Medicine, Hospital South West Jutland, University Hospital of Southern Denmark, Esbjerg, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Hilberg', 'Affiliation': 'Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Hess', 'Affiliation': 'Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Torben Tranborg', 'Initials': 'TT', 'LastName': 'Jensen', 'Affiliation': 'Department of Medicine, Hospital South West Jutland, University Hospital of Southern Denmark, Esbjerg, Denmark.'}, {'ForeName': 'Else-Marie', 'Initials': 'EM', 'LastName': 'Bladbjerg', 'Affiliation': 'Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Claus Bogh', 'Initials': 'CB', 'LastName': 'Juhl', 'Affiliation': 'Department of Medicine, Hospital South West Jutland, University Hospital of Southern Denmark, Esbjerg, Denmark.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S350133']
3153,35237030,Cortical Trajectory Fixation Versus Traditional Pedicle-Screw Fixation in the Treatment of Lumbar Degenerative Patients with Osteoporosis: A Prospective Randomized Controlled Trial.,"Study Design


This was a prospective randomized controlled trial study.
Objective


To elucidate clinical and radiographic outcomes and complications of cortical bone trajectory (CBT)-screw fixation in patients with osteoporosis at 24-month follow-up and to compare the results with those after transforaminal lumbar interbody fusion (TLIF) using traditional pedicle screw (PS) fixation.
Methods


We enrolled 124 patients and randomly assigned them to two groups (each group had 62 participants). The primary outcome was fusion rate. Secondary outcomes were VAS, Oswestry Disability Index (ODI), and Japanese Orthopaedic Association (JOA) scores, operation duration, incision length, estimated blood loss, drainage volume, radiological outcomes, and complications.
Results


At the 6- and 12-month follow-up points, similar fusion rates were observed based on CT scans in both groups ( P =0.583 and 0.583). CBT provided significantly better short-term functional status at 3 months postoperation on ODI and JOA scores ( P =0.012 and 0) and similar improvements in pain intensity and functional status at other follow-up points. In addition, CBT resulted in significantly better surgical characteristics. Notably, CBT fixation led to lower incidence of screw loosening ( P =0.006).
Conclusion


CBT-screw fixation for single-level lumbar fusion in patients with osteoporosis provided improvement in clinical symptoms comparable to that of TLIF using PS fixation. Significantly better lumbar stability was found in the CBT group. We suggest that CBT-screw fixation is a reasonable and superior alternative to PS in TLIF in osteoporosis.
Trial Registration Number


ChiCTR1900022658.
Date of Registration


April 20, 2019.",2022,CBT provided significantly better short-term functional status at 3 months postoperation on ODI and JOA scores ( P =0.012 and 0) and similar improvements in pain intensity and functional status at other follow-up points.,"['Lumbar Degenerative Patients with Osteoporosis', 'patients with osteoporosis at 24-month follow-up', '124 patients and randomly assigned them to two groups (each group had 62 participants', 'patients with osteoporosis']","['CBT', 'CBT fixation', 'transforaminal lumbar interbody fusion (TLIF) using traditional pedicle screw (PS) fixation', 'Cortical Trajectory Fixation Versus Traditional Pedicle-Screw Fixation', 'cortical bone trajectory (CBT)-screw fixation', 'CBT-screw fixation']","['lumbar stability', 'pain intensity and functional status', 'screw loosening', 'ODI and JOA scores', 'short-term functional status', 'VAS, Oswestry Disability Index (ODI), and Japanese Orthopaedic Association (JOA) scores, operation duration, incision length, estimated blood loss, drainage volume, radiological outcomes, and complications', 'fusion rate']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C0222652', 'cui_str': 'Cortex of bone'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0410830', 'cui_str': 'Loosening of screw'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]",124.0,0.0285107,CBT provided significantly better short-term functional status at 3 months postoperation on ODI and JOA scores ( P =0.012 and 0) and similar improvements in pain intensity and functional status at other follow-up points.,"[{'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': ""Department of Spine Surgery, Beijing Chao-Yang Hospital, Capital Medical University of China, Beijing, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Hai', 'Affiliation': ""Department of Spine Surgery, Beijing Chao-Yang Hospital, Capital Medical University of China, Beijing, People's Republic of China.""}, {'ForeName': 'Yuzeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Spine Surgery, Beijing Chao-Yang Hospital, Capital Medical University of China, Beijing, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Guan', 'Affiliation': ""Department of Spine Surgery, Beijing Chao-Yang Hospital, Capital Medical University of China, Beijing, People's Republic of China.""}, {'ForeName': 'Aixing', 'Initials': 'A', 'LastName': 'Pan', 'Affiliation': ""Department of Spine Surgery, Beijing Chao-Yang Hospital, Capital Medical University of China, Beijing, People's Republic of China.""}, {'ForeName': 'Xinuo', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Spine Surgery, Beijing Chao-Yang Hospital, Capital Medical University of China, Beijing, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': ""Department of Spine Surgery, Beijing Chao-Yang Hospital, Capital Medical University of China, Beijing, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Spine Surgery, Beijing Chao-Yang Hospital, Capital Medical University of China, Beijing, People's Republic of China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yin', 'Affiliation': ""Department of Spine Surgery, Beijing Chao-Yang Hospital, Capital Medical University of China, Beijing, People's Republic of China.""}]",Clinical interventions in aging,['10.2147/CIA.S349533']
3154,35237394,Improvement in pain-related quality of life in patients with hemophilia A treated with rFVIIIFc individualized prophylaxis: post hoc analysis from the A-LONG study.,"Background


Pain, a common symptom of hemophilia, begins early in life primarily due to joint bleeding. Recurrent bleeding adversely affects patients' pain-related physical functioning, which can negatively impact their quality of life (QoL).
Objective


Post hoc analysis of data from the A-LONG study (NCT01181128), to assess change over time in pain-related QoL in patients with severe hemophilia A treated prophylactically with recombinant factor VIII Fc fusion protein (rFVIIIFc).
Methods


Patients who completed Haem-A-QoL (17-65 years) and EQ-5D-3L (⩾12-65 years) questionnaires at baseline (BL) and end of study (EoS). Individual-level changes were assessed using three pain-related items of the Haem-A-QoL 'Physical Health' domain and the pain/discomfort item of EQ-5D-3L. Distributions of responses (EoS  versus  BL) were compared using McNemar's test.
Results


A significantly greater proportion of patients reported they did not experience painful swellings ( n  = 87; 66%  versus  46%,  p  <   0.01) or pain in their joints ( n  = 89; 42%  versus  27%;  p  <   0.05) at EoS  versus  BL. The proportion of patients who did not find it painful to move numerically increased at EoS  versus  BL ( n  = 86; 47%  versus  38%;  p  = NS). A significantly greater proportion of patients reported no pain/discomfort at EoS  versus  BL ( n  = 116; 45%  versus  34%;  p  <   0.05).
Conclusion


This study reports the effect of FVIII prophylaxis on patient-reported measures of pain over time in patients with severe hemophilia A. The results of this post hoc analysis showed improvements in pain from BL to EoS in patients receiving rFVIIIFc individualized prophylaxis indicating effective pain management, a key component of patient care.",2022,The proportion of patients who did not find it painful to move numerically increased at EoS  versus  BL ( n  = 86; 47%  versus  38%;  p  = NS).,"['patients with severe hemophilia', 'patients with hemophilia', 'Methods\n\n\nPatients who completed Haem-A-QoL (17-65\u2009years) and EQ-5D-3L (⩾12-65\u2009years) questionnaires at baseline (BL) and end of study (EoS', 'patients with severe hemophilia A']","['recombinant factor VIII Fc fusion protein (rFVIIIFc', 'rFVIIIFc individualized prophylaxis', 'FVIII prophylaxis']","['pain', 'pain/discomfort', 'pain-related quality of life', 'experience painful swellings', 'quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018966', 'cui_str': 'Heme'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}]","[{'cui': 'C0795577', 'cui_str': 'recombinant antihemophilic factor VIII'}, {'cui': 'C0162768', 'cui_str': 'Fusion protein'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C2732002', 'cui_str': 'Antihemophilic Factor, Human Recombinant'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}]",,0.0225002,The proportion of patients who did not find it painful to move numerically increased at EoS  versus  BL ( n  = 86; 47%  versus  38%;  p  = NS).,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pasi', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, Haematology Day Unit and Haemophilia Centre, 2nd Floor, Central Tower, The Royal London Hospital, Whitechapel, London E1 1BB, UK.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Hermans', 'Affiliation': 'Division of Hematology, Hemostasis and Thrombosis Unit, Saint-Luc University Hospital, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Zalmai', 'Initials': 'Z', 'LastName': 'Hakimi', 'Affiliation': 'Swedish Orphan Biovitrum AB, Stockholm, Sweden.'}, {'ForeName': 'Jameel', 'Initials': 'J', 'LastName': 'Nazir', 'Affiliation': 'Swedish Orphan Biovitrum AB, Stockholm, Sweden.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Aballéa', 'Affiliation': 'Creativ-Ceutical, Rotterdam, The Netherlands.'}, {'ForeName': 'Monia', 'Initials': 'M', 'LastName': 'Ezzalfani', 'Affiliation': 'Creativ-Ceutical, Paris, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Fatoye', 'Affiliation': 'Department of Health Professions, Faculty of Health and Education, Manchester Metropolitan University, Manchester, UK.'}]",Therapeutic advances in hematology,['10.1177/20406207221079482']
3155,35237948,Can a single session of treadmill-based slip training reduce daily life falls in community-dwelling older adults? A randomized controlled trial.,"BACKGROUND


Task-specific training with single-session overground slip simulation has shown to reduce real-life falls in older adults.
AIMS


The purpose of this study was to determine if fall-resisting behavior acquired from a single-session treadmill-based gait slip training could be retained to reduce older adults' falls in everyday living over a 6-month follow-up period.
METHODS


143 community-dwelling older adults (≥ 65 years old) were randomly assigned to either the treadmill-based gait slip training group (N = 73), in which participants were exposed to 40 unpredictable treadmill slips, or the control group (N = 70), in which participants walked on a treadmill at their comfortable speed. Participants reported their falls from the preceding year (through self-report history) and over the following 6 months (through fall diaries and monitored with phone calls).
RESULTS


There was no main effect of time (retrospective vs. prospective fall) and training (treadmill training vs. control) on fall reduction (p > 0.05 for both). The survival distributions of event of all-cause falls or slip falls were comparable between groups (p > 0.05 for both).
DISCUSSION


Unlike overground slip training where a single training session could significantly reduce everyday falls in a 6-month follow-up period, the results indicated that one treadmill-based gait slip training session by itself was unable to produce similar effects.
CONCLUSION


Further modification of the training protocol by increasing training dosage (e.g., number of sessions or perturbation intensity) may be necessary to enhance transfer to daily living. This study (NCT02126488) was registered on April 30, 2014.",2022,"The survival distributions of event of all-cause falls or slip falls were comparable between groups (p > 0.05 for both).
","['community-dwelling older adults', '143 community-dwelling older adults (≥', ""older adults' falls in everyday living over a 6-month follow-up period"", 'older adults', '65\xa0years old']","['single-session treadmill-based gait slip training', 'treadmill-based slip training', 'treadmill-based gait slip training group (N\u2009=\u200973), in which participants were exposed to 40 unpredictable treadmill slips, or the control group (N\u2009=\u200970), in which participants walked on a treadmill at their comfortable speed']","['fall reduction', 'everyday falls', 'survival distributions of event of all-cause falls or slip falls']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}]",,0.0239788,"The survival distributions of event of all-cause falls or slip falls were comparable between groups (p > 0.05 for both).
","[{'ForeName': 'Yiru', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Therapy, College of Applied Health and Sciences, University of Illinois at Chicago, Chicago, IL, 60612, USA.'}, {'ForeName': 'Shuaijie', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Therapy, College of Applied Health and Sciences, University of Illinois at Chicago, Chicago, IL, 60612, USA.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Center for Mobility and Rehabilitation Engineering Research, Kessler Foundation, West Orange, NJ, 07052, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Applied Health and Sciences, University of Illinois at Chicago, Chicago, IL, 60612, USA.'}, {'ForeName': 'Yi-Chung', 'Initials': 'YC', 'LastName': 'Pai', 'Affiliation': 'Department of Physical Therapy, College of Applied Health and Sciences, University of Illinois at Chicago, Chicago, IL, 60612, USA. clivepai08@gmail.com.'}, {'ForeName': 'Tanvi', 'Initials': 'T', 'LastName': 'Bhatt', 'Affiliation': 'Department of Physical Therapy, College of Applied Health and Sciences, University of Illinois at Chicago, Chicago, IL, 60612, USA. tbhatt6@uic.edu.'}]",Aging clinical and experimental research,['10.1007/s40520-022-02090-3']
3156,35237893,Randomized controlled trial of astaxanthin impacts on antioxidant status and assisted reproductive technology outcomes in women with polycystic ovarian syndrome.,"PURPOSE


Polycystic ovary syndrome (PCOS), the most common endocrinopathy in women, is typically accompanied by a defective oxidative defense system. Here, we investigated the effect of astaxanthin (AST) as a powerful antioxidant on the oxidative stress (OS) response and assisted reproductive technology (ART) outcomes in PCOS patients.
METHODS


In this double-blind, randomized, placebo-controlled trial, PCOS patients were randomly assigned into two groups. The intervention group received 8 mg AST, and the control group received the placebo daily for 40 days. The primary outcomes were the serum and follicular fluid (FF) levels of the OS biomarkers and the expression levels of the specific genes and proteins in the oxidative stress response pathway. The secondary outcomes were considered ART outcomes.
RESULTS


According to our findings, a 40-day course of AST supplementation led to significantly higher levels of serum CAT and TAC in the AST group compared to the placebo group. However, there were no significant intergroup differences in the serum MDA and SOD levels, as well as the FF levels of OS markers. The expression of Nrf2, HO-1, and NQ-1 was significantly increased in the granulosa cells (GCs) of the AST group. Moreover, the MII oocyte and high-quality embryo rate were significantly increased in the AST group compared to the placebo group. We found no significant intergroup difference in the chemical and clinical pregnancy rates.
CONCLUSION


AST treatment has been shown to increase both serum TAC levels and activation of the Nrf2 axis in PCOS patients' GCs.
TRIAL REGISTRATION


ClincialTrials.gov Identifier: NCT03991286.",2022,"Moreover, the MII oocyte and high-quality embryo rate were significantly increased in the AST group compared to the placebo group.","['Polycystic ovary syndrome (PCOS', 'women with polycystic ovarian syndrome', 'PCOS patients']","['placebo', 'astaxanthin', 'astaxanthin (AST', 'AST', '8\xa0mg AST']","['oxidative stress (OS) response and assisted reproductive technology (ART) outcomes', 'serum and follicular fluid (FF) levels of the OS biomarkers and the expression levels of the specific genes and proteins in the oxidative stress response pathway', 'serum CAT and TAC', 'FF levels of OS markers', 'expression of Nrf2, HO-1, and NQ-1', 'serum MDA and SOD levels', 'MII oocyte and high-quality embryo rate', 'serum TAC levels and activation', 'antioxidant status', 'chemical and clinical pregnancy rates']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0052565', 'cui_str': 'astaxanthin'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0872104', 'cui_str': 'Assisted reproductive technology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0016431', 'cui_str': 'Liquor Folliculi'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C1565078', 'cui_str': 'NFE2L2 protein, human'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",,0.548502,"Moreover, the MII oocyte and high-quality embryo rate were significantly increased in the AST group compared to the placebo group.","[{'ForeName': 'Roghaye', 'Initials': 'R', 'LastName': 'Gharaei', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Alyasin', 'Affiliation': 'Department of Infertility, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Mahdavinezhad', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Esmaeil', 'Initials': 'E', 'LastName': 'Samadian', 'Affiliation': 'Laboratory Sciences Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Zhaleh', 'Initials': 'Z', 'LastName': 'Ashrafnezhad', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fardin', 'Initials': 'F', 'LastName': 'Amidi', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran. Famidi@tums.ac.ir.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-022-02432-0']
3157,35237867,The combined effects of exercise-induced muscle damage and heat stress on acute kidney stress and heat strain during subsequent endurance exercise.,"PURPOSE


The purpose of the study was to investigate the combined effect of downhill running and heat stress on muscle damage, as well as on heat strain and kidney stress during subsequent running in the heat.
METHODS


In a randomized cross-over study, ten non-heat-acclimated, physically active males completed downhill running in temperate (EIMD in Temp) and hot (EIMD in Hot) conditions followed by an exercise-heat stress (HS) test after 3-h seated rest. Blood and urine samples were collected immediately pre- and post-EIMD and HS, and 24 h post-EIMD (post-24 h). Core temperature and thermal sensation were measured to evaluate heat strain. Serum creatine kinase (CK), maximal voluntary isometric contraction of the quadriceps (MVC) and perceived muscle soreness were measured to evaluate muscle damage. Urinary neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) levels were measured to indicate acute kidney stress.
RESULTS


CK, MVC and perceived soreness were not different between conditions at any timepoints. In the EIMD in Hot condition, urinary NGAL was significantly elevated from pre- to post-HS (pre-HS: 6.56 {1.53-12.24} ng/min, post-HS: 13.72 {7.67-21.46} ng/min, p = 0.034). Such elevation of NGAL or KIM-1 was not found in the EIMD in Temp condition.
CONCLUSIONS


As compared with downhill running in a temperate environment, downhill running in a hot environment does not appear to aggravate muscle damage. However, elevated NGAL levels following EIMD in a hot environment suggest such exercise may increase risk of mild acute kidney injury during subsequent endurance exercise in the heat.",2022,"Urinary neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) levels were measured to indicate acute kidney stress.
",['acute kidney stress and heat strain during subsequent endurance exercise'],"['exercise-induced muscle damage and heat stress', 'downhill running in temperate (EIMD in Temp) and hot (EIMD in Hot) conditions followed by an exercise-heat stress (HS) test after 3-h seated rest', 'downhill running and heat stress']","['Urinary neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) levels', 'urinary NGAL', 'heat strain and kidney stress', 'Blood and urine samples', 'Serum creatine kinase (CK), maximal voluntary isometric contraction of the quadriceps (MVC) and perceived muscle soreness', 'Core temperature and thermal sensation', 'CK, MVC and perceived soreness']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0282507', 'cui_str': 'Stress Disorders, Heat'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0215955', 'cui_str': 'LCN2 protein, human'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0858112', 'cui_str': 'Serum creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}]",10.0,0.041066,"Urinary neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) levels were measured to indicate acute kidney stress.
","[{'ForeName': 'Zidong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Health, Exercise and Sport Sciences, University of New Mexico, Albuquerque, NM, USA. zidongl@nsula.edu.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'McKenna', 'Affiliation': 'Department of Health, Exercise and Sport Sciences, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Fennel', 'Affiliation': 'Department of Health, Exercise and Sport Sciences, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Roberto Carlos', 'Initials': 'RC', 'LastName': 'Nava', 'Affiliation': 'Department of Health, Exercise and Sport Sciences, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wells', 'Affiliation': 'Department of Health, Exercise and Sport Sciences, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Ducharme', 'Affiliation': 'Department of Health, Exercise and Sport Sciences, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Houck', 'Affiliation': 'Department of Health, Exercise and Sport Sciences, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Morana', 'Affiliation': 'Department of Health, Exercise and Sport Sciences, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Mermier', 'Affiliation': 'Department of Health, Exercise and Sport Sciences, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kuennen', 'Affiliation': 'Department of Exercise Science, High Point University, High Point, NC, USA.'}, {'ForeName': 'Flavio de Castro', 'Initials': 'FC', 'LastName': 'Magalhaes', 'Affiliation': 'Department of Physical Education, Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Fabiano', 'Initials': 'F', 'LastName': 'Amorim', 'Affiliation': 'Department of Health, Exercise and Sport Sciences, University of New Mexico, Albuquerque, NM, USA.'}]",European journal of applied physiology,['10.1007/s00421-022-04919-1']
3158,35237863,"A review of ferric citrate clinical studies, and the rationale and design of the Ferric Citrate and Chronic Kidney Disease in Children (FIT4KiD) trial.","Pediatric chronic kidney disease (CKD) is characterized by many co-morbidities, including impaired growth and development, CKD-mineral and bone disorder, anemia, dysregulated iron metabolism, and cardiovascular disease. In pediatric CKD cohorts, higher circulating concentrations of fibroblast growth factor 23 (FGF23) are associated with some of these adverse clinical outcomes, including CKD progression and left ventricular hypertrophy. It is hypothesized that lowering FGF23 levels will reduce the risk of these events and improve clinical outcomes. Reducing FGF23 levels in CKD may be accomplished by targeting two key stimuli of FGF23 production-dietary phosphate absorption and iron deficiency. Ferric citrate is approved for use as an enteral phosphate binder and iron replacement product in adults with CKD. Clinical trials in adult CKD cohorts have also demonstrated that ferric citrate decreases circulating FGF23 concentrations. This review outlines the possible deleterious effects of excess FGF23 in CKD, summarizes data from the adult CKD clinical trials of ferric citrate, and presents the Ferric Citrate and Chronic Kidney Disease in Children (FIT4KiD) study, a randomized, placebo-controlled trial to evaluate the effects of ferric citrate on FGF23 in pediatric patients with CKD stages 3-4 (ClinicalTrials.gov Identifier NCT04741646).",2022,"In pediatric CKD cohorts, higher circulating concentrations of fibroblast growth factor 23 (FGF23) are associated with some of these adverse clinical outcomes, including CKD progression and left ventricular hypertrophy.","['adults with CKD', 'Pediatric chronic kidney disease (CKD', 'pediatric patients with CKD stages', 'Children (FIT4KiD) trial']","['ferric citrate', 'placebo', 'Ferric citrate']",['CKD progression and left ventricular hypertrophy'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0060231', 'cui_str': 'ferric citrate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}]",,0.179342,"In pediatric CKD cohorts, higher circulating concentrations of fibroblast growth factor 23 (FGF23) are associated with some of these adverse clinical outcomes, including CKD progression and left ventricular hypertrophy.","[{'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Hanudel', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, David Geffen School of Medicine at UCLA and UCLA Mattel Children's Hospital, 10833 Le Conte Avenue, Los Angeles, CA, 90095, USA.""}, {'ForeName': 'Marciana L', 'Initials': 'ML', 'LastName': 'Laster', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, David Geffen School of Medicine at UCLA and UCLA Mattel Children's Hospital, 10833 Le Conte Avenue, Los Angeles, CA, 90095, USA.""}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Portale', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, UCSF School of Medicine and UCSF Benioff Children's Hospital, San Francisco, CA, USA.""}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Dokras', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, Southwestern School of Medicine and Children's Medical Center, University of Texas, Dallas, TX, USA.""}, {'ForeName': 'Raymond P', 'Initials': 'RP', 'LastName': 'Quigley', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, Southwestern School of Medicine and Children's Medical Center, University of Texas, Dallas, TX, USA.""}, {'ForeName': 'German A Lozano', 'Initials': 'GAL', 'LastName': 'Guzman', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, Tower Health and St. Christopher's Hospital for Children, Philadelphia, PA, USA.""}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Zaritsky', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, Tower Health and St. Christopher's Hospital for Children, Philadelphia, PA, USA.""}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Hayde', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, Albert Einstein College of Medicine and Children's Hospital at Montefiore, Bronx, NY, USA.""}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Kaskel', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, Albert Einstein College of Medicine and Children's Hospital at Montefiore, Bronx, NY, USA.""}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Mitsnefes', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Ramirez', 'Affiliation': 'Department of Pediatrics, Division of Nephrology, Arnold Palmer Hospital for Children, Orlando, FL, USA.'}, {'ForeName': 'Peace D', 'Initials': 'PD', 'LastName': 'Imani', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA.""}, {'ForeName': 'Poyyapakkam R', 'Initials': 'PR', 'LastName': 'Srivaths', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA.""}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Kogon', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, Perelman School of Medicine at the University of Pennsylvania and Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Denburg', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, Perelman School of Medicine at the University of Pennsylvania and Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Tom D', 'Initials': 'TD', 'LastName': 'Blydt-Hansen', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, University of British Columbia and British Columbia Children's Hospital, Vancouver, BC, Canada.""}, {'ForeName': 'Loretta Z', 'Initials': 'LZ', 'LastName': 'Reyes', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA.""}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Greenbaum', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA.""}, {'ForeName': 'Darcy K', 'Initials': 'DK', 'LastName': 'Weidemann', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, University of Missouri-Kansas City School of Medicine and Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Warady', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, University of Missouri-Kansas City School of Medicine and Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Elashoff', 'Affiliation': 'Department of Medicine/Biostatistics, Division of General Internal Medicine and Health Service Research, David Geffen School of Medicine at UCLA, Los Angeles, USA.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Mendley', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Division of Kidney, Urologic, and Hematologic Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Isakova', 'Affiliation': 'Department of Medicine, Division of Nephrology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Isidro B', 'Initials': 'IB', 'LastName': 'Salusky', 'Affiliation': ""Department of Pediatrics, Division of Nephrology, David Geffen School of Medicine at UCLA and UCLA Mattel Children's Hospital, 10833 Le Conte Avenue, Los Angeles, CA, 90095, USA. isalusky@mednet.ucla.edu.""}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-022-05492-7']
3159,35237748,A randomized double-blind placebo-controlled clinical trial of nitazoxanide for treatment of mild or moderate COVID-19.,"Background


There is an urgent need for treatments of mild or moderate COVID-19 in an outpatient setting.
Methods


A randomized double-blind placebo-controlled clinical trial in 36 centers in the U.S. between August 2020 and February 2021 investigated the safety and effectiveness of oral nitazoxanide 600 mg twice daily for five days in outpatients with symptoms of mild or moderate COVID-19 enrolled within 72 h of symptom onset (ClinicalTrials.gov NCT04486313). Efficacy endpoints were time to sustained clinical recovery (TSR, a novel primary endpoint) and proportion of participants progressing to severe illness within 28 days (key secondary).
Findings


1092 participants were enrolled. 379 with laboratory-confirmed SARS-CoV-2 infection were analyzed. In the primary analysis, median (IQR) TSR were 13·3 (6·3, >21) and 12·4 (7·2, >21) days for the nitazoxanide and placebo groups, respectively ( p  = 0·88). 1 of 184 (0·5%) treated with nitazoxanide progressed to severe illness compared to 7 of 195 (3·6%) treated with placebo (key secondary analysis, odds ratio 5·6 [95% CI 0·7 - 46·1], relative risk reduction 85%,  p  = 0·07). In the pre-defined stratum with mild illness at baseline, nitazoxanide-treated participants experienced reductions in median TSR (3·1 days,  p  = 0·09) and usual health (5·2 days,  p  < 0·01) compared to placebo. Nitazoxanide was safe and well tolerated.
Interpretation


Further trials with larger numbers are warranted to evaluate efficacy of nitazoxanide therapy in preventing progression to severe illness in patients at high risk of severe illness and reducing TSR in patients with mild illness.",2022,"1 of 184 (0·5%) treated with nitazoxanide progressed to severe illness compared to 7 of 195 (3·6%) treated with placebo (key secondary analysis, odds ratio 5·6","['Findings\n\n\n1092 participants were enrolled', '36 centers in the U.S. between August 2020 and February 2021 investigated the', 'outpatients with symptoms of mild or moderate COVID-19 enrolled within 72\xa0h of symptom onset (ClinicalTrials.gov NCT04486313', 'mild or moderate COVID-19', 'patients with mild illness']","['placebo', 'nitazoxanide', 'nitazoxanide therapy', 'oral nitazoxanide', 'nitazoxanide and placebo', 'Nitazoxanide']","['safety and effectiveness', 'severe illness', 'safe and well tolerated', 'median (IQR) TSR', 'usual health', 'median TSR', 'time to sustained clinical recovery (TSR, a novel primary endpoint) and proportion of participants progressing to severe illness within 28 days (key secondary']","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0068788', 'cui_str': 'nitazoxanide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",1092.0,0.840195,"1 of 184 (0·5%) treated with nitazoxanide progressed to severe illness compared to 7 of 195 (3·6%) treated with placebo (key secondary analysis, odds ratio 5·6","[{'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Rossignol', 'Affiliation': 'Romark Institute of Medical Research, Tampa, FL, United States.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Bardin', 'Affiliation': 'Romark Institute of Medical Research, Tampa, FL, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Fulgencio', 'Affiliation': 'Romark Institute of Medical Research, Tampa, FL, United States.'}, {'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Mogelnicki', 'Affiliation': 'Romark Institute of Medical Research, Tampa, FL, United States.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bréchot', 'Affiliation': 'Romark Institute of Medical Research, Tampa, FL, United States.'}]",EClinicalMedicine,['10.1016/j.eclinm.2022.101310']
3160,35237741,Does wearing arthritis gloves help with hand pain and function? A qualitative study into patients' views and experiences.,"Objective


Arthritis gloves are frequently prescribed to people with undifferentiated inflammatory arthritis (UIA) or RA to help reduce hand pain and improve function. Nested within a randomized controlled trial testing the effectiveness of arthritis gloves (Isotoner gloves  vs  loose-fitting placebo gloves) in people with RA and UIA, this qualitative study aimed to explore participants' views on the impact of wearing arthritis gloves on their hand pain and function.
Methods


Semi-structured one-to-one interviews were conducted with purposively selected participants following 12 weeks of glove wearing. Participants and the interviewer were blinded to the treatment allocation. Interviews were audio-recorded, transcribed verbatim and analysed using thematic analysis.
Results


Participants (intervention:  n  = 10; control:  n  = 9) recruited from 13 National Health Service hospital sites in the UK participated in the interviews. Two main themes, with sub-themes, were elicited from the data: mechanisms determining glove use: 'As soon as your joints get a bit warmer, the pain actually eases' (thermal qualities; glove use in daily activities; glove use during sleep); and ambivalence about benefits of arthritis gloves: 'I suppose a normal pair of gloves would do the same sort of thing?' (are they a help or hindrance?; aesthetic appeal; future use of gloves).
Conclusion


Participants had ambivalent views on the impact of both the intervention and the loose-fitting placebo gloves on their hand pain and function, identifying warmth as the main benefit. Ordinary mid-finger-length gloves widely accessible from high street suppliers could deliver warmth and provide the perceived benefits to hand pain and function.  Trial registration:  ISRCTN, ISRCTN25892131; registered 5 September 2016 : retrospectively registered.",2022,"Nested within a randomized controlled trial testing the effectiveness of arthritis gloves (Isotoner gloves  vs  loose-fitting placebo gloves) in people with RA and UIA, this qualitative study aimed to explore participants' views on the impact of wearing arthritis gloves on their hand pain and function.
","['people with RA and UIA', 'people with undifferentiated inflammatory arthritis (UIA) or', 'Results\n\n\nParticipants (intervention:  n  = 10; control:  n  = 9) recruited from 13 National Health Service hospital sites in the UK', ""patients' views and experiences""]","['arthritis gloves (Isotoner gloves  vs  loose-fitting placebo gloves', 'RA']","[""your joints get a bit warmer, the pain actually eases' (thermal qualities; glove use in daily activities; glove use during sleep); and ambivalence about benefits of arthritis gloves: 'I suppose a normal pair of gloves would do the same sort of thing""]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1562028', 'cui_str': 'Undifferentiated inflammatory arthritis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]",,0.365031,"Nested within a randomized controlled trial testing the effectiveness of arthritis gloves (Isotoner gloves  vs  loose-fitting placebo gloves) in people with RA and UIA, this qualitative study aimed to explore participants' views on the impact of wearing arthritis gloves on their hand pain and function.
","[{'ForeName': 'Yeliz', 'Initials': 'Y', 'LastName': 'Prior', 'Affiliation': 'Centre for Health Sciences Research, School of Health and Society, University of Salford, Salford.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Bartley', 'Affiliation': 'Rehab for Independence Ltd, Heskin.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'School of Health Sciences, University of Southampton, Southampton.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Firth', 'Affiliation': 'Pennine Musculoskeletal Partnership, Oldham.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Culley', 'Affiliation': 'Patient Research Partner, Derby.'}, {'ForeName': 'Terence W', 'Initials': 'TW', 'LastName': ""O'Neill"", 'Affiliation': 'Centre for Epidemiology Versus Arthritis, University of Manchester.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hammond', 'Affiliation': 'Centre for Health Sciences Research, School of Health and Society, University of Salford, Salford.'}]",Rheumatology advances in practice,['10.1093/rap/rkac007']
3161,35238148,In vivo evaluation of topical ascorbic acid application on skin aging by 50MHz ultrasound.,"Ascorbic acid (AA) is a powerful antioxidant capable of acting significantly both in the prevention and treatment of the skin aging process. One way to assess the in vivo efficacy of anti-aging treatments is by using the high-frequency ultrasound (HFUS) skin image analysis technique, a non-invasive approach that allows for a new level of evaluating the effectiveness of dermatological and cosmetic products. The aim of the present study was to assess the performance of a topical emulsion of liquid crystalline structures containing AA using the 50 MHz HFUS skin image analysis method. Twenty-five healthy female participants between 35 and 60 years old were included, all of whom randomly applied a placebo formulation and an AA-containing formulation to each forearm, once a day, for 30 days. HFUS measurements were performed before using the products (T0), two hours later (T2h), and after 30 days of use (T30d). The analyzed parameters included total skin, dermal, and epidermal echogenicity; variation and mean thickness of total skin, the epidermis and dermis; and surface roughness. Statistical analyses were performed using the Friedman test, followed by Dunn's test for comparisons of multiple means (α=0.05). A significant increase in total skin and dermal echogenicity was observed after topical AA application. Our findings suggest that collagen synthesis significantly increased after topical therapy with AA, which was responsible for the increment in dermal echogenicity. This study showed, through the HFUS technique, that the topical use of AA promoted dermal redensification after 30 days of application.",2022,A significant increase in total skin and dermal echogenicity was observed after topical AA application.,['Twenty-five healthy female participants between 35 and 60 years old'],"['topical ascorbic acid application', 'Ascorbic acid (AA', 'placebo']","['dermal echogenicity', 'total skin, dermal, and epidermal echogenicity; variation and mean thickness of total skin, the epidermis and dermis; and surface roughness', 'collagen synthesis', 'total skin and dermal echogenicity', 'skin aging by 50MHz ultrasound']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0037271', 'cui_str': 'Skin aging'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",25.0,0.0248227,A significant increase in total skin and dermal echogenicity was observed after topical AA application.,"[{'ForeName': 'Mariane Massufero', 'Initials': 'MM', 'LastName': 'Vergilio', 'Affiliation': 'Internal Medicine, School of Medical Sciences, University of Campinas (UNICAMP), Brazil.'}, {'ForeName': 'Laura Moretti', 'Initials': 'LM', 'LastName': 'Aiello', 'Affiliation': 'Pharmaceutical Sciences, School of Pharmaceutical Sciences, University of Campinas (UNICAMP), Brazil.'}, {'ForeName': 'Andreza Sonego', 'Initials': 'AS', 'LastName': 'Furlan', 'Affiliation': 'Pharmaceutical Sciences, School of Pharmaceutical Sciences, University of Campinas (UNICAMP), Brazil.'}, {'ForeName': 'Amanda Costa', 'Initials': 'AC', 'LastName': 'Caritá', 'Affiliation': 'Department of Translational Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil.'}, {'ForeName': 'Jaqueline Rezende', 'Initials': 'JR', 'LastName': 'Azevedo', 'Affiliation': ""University of Lyon, Laboratoire d'Automatique, de Génie des Procédés et Génie Pharmaceutique (LAGEPP), CNRS, UMR 5007, Université Claude Bernard Lyon 1, 43 bd 11 Novembre, 69622, Villeurbanne, France.""}, {'ForeName': 'Marie-Alexandrine', 'Initials': 'MA', 'LastName': 'Bolzinger', 'Affiliation': ""University of Lyon, Laboratoire d'Automatique, de Génie des Procédés et Génie Pharmaceutique (LAGEPP), CNRS, UMR 5007, Université Claude Bernard Lyon 1, 43 bd 11 Novembre, 69622, Villeurbanne, France.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Chevalier', 'Affiliation': ""University of Lyon, Laboratoire d'Automatique, de Génie des Procédés et Génie Pharmaceutique (LAGEPP), CNRS, UMR 5007, Université Claude Bernard Lyon 1, 43 bd 11 Novembre, 69622, Villeurbanne, France.""}, {'ForeName': 'Gislaine Ricci', 'Initials': 'GR', 'LastName': 'Leonardi', 'Affiliation': 'Internal Medicine, School of Medical Sciences, University of Campinas (UNICAMP), Brazil.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14892']
3162,35238144,Topical finasteride for male and female pattern hair loss: Is it a safe and effective alternative?,"Oral finasteride is an FDA-approved treatment for androgenetic alopecia (AGA). Topical finasteride, while not FDA approved, lacks the systemic adverse effects associated with oral finasteride. The efficacy of topical finasteride has been evaluated. A structured search in PubMed and Google Scholar identified 864 records, with 32 articles meeting the inclusion criteria for review. In a phase III, randomized, controlled trial, the efficacies of topical 0.25% w/w finasteride spray (1-4 sprays; 50-200 μL/day) and once-daily finasteride 1 mg oral tablet were similar when administered for 24 weeks (mean change from baseline, 20.2 vs. 21.1 hairs/cm 2  ). Additionally, a double-blind, randomized trial compared the efficacies of twice-daily finasteride 1% topical gel and once-daily finasteride 1 mg oral tablet for six months, and found similar results in both groups. Also, a combination of topical minoxidil and topical finasteride may enhance efficacy. Topical finasteride reduces both scalp and plasma DHT levels. In an open-label pharmacodynamic study, a seven-day treatment of twice-daily finasteride 0.25% topical solution and once-daily finasteride 1 mg oral tablet provided similar inhibition of plasma DHT. Topical finasteride reduces the potential for systemic side effects, including the risk of sexual dysfunction. The side effects are localized to the application site, for example, scalp pruritus, burning sensation, irritation, contact dermatitis, and erythema. Topical finasteride may be an alternative for those concerned about the oral formulation's systemic side effects.",2022,Topical finasteride reduces both scalp and plasma DHT levels.,"['male and female pattern hair loss', 'PubMed and Google Scholar identified 864 records, with 32 articles meeting the inclusion criteria for review']","['topical 0.25% w/w finasteride spray', 'finasteride', 'Topical finasteride', 'topical finasteride', 'topical minoxidil and topical finasteride', 'finasteride 0.25% topical solution and once-daily finasteride', 'twice-daily finasteride 1% topical gel and once-daily finasteride', 'Oral finasteride']","['risk of sexual dysfunction', 'scalp and plasma DHT levels']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0060389', 'cui_str': 'Finasteride'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0730881', 'cui_str': 'Regaine'}, {'cui': 'C0991555', 'cui_str': 'Cutaneous solution'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1160728', 'cui_str': 'Cutaneous gel'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0038148', 'cui_str': 'androstanolone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.291176,Topical finasteride reduces both scalp and plasma DHT levels.,"[{'ForeName': 'Aditya K', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Mediprobe Research Inc, London, ON, Canada.'}, {'ForeName': 'Mesbah', 'Initials': 'M', 'LastName': 'Talukder', 'Affiliation': 'Mediprobe Research Inc, London, ON, Canada.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14895']
3163,35240263,Can supplemental protein to low-protein containing meals superimpose on resistance-training muscle adaptations in older adults? A randomized clinical trial.,"PURPOSE


To evaluate the effects of supplementing protein to the low-protein containing meals on selected parameters of muscle mass, strength, and functional capacity in older individuals undergoing resistance training.
METHODS


Thirty-one male and female older individuals (60 to 80 years) were randomized into either a whey protein/WP (n = 15, 20 g at breakfast + 20 g at dinner) or placebo-maltodextrin/PL (n = 16, 20 g at breakfast + 20 g at dinner) group. Both groups underwent a supervised, progressive resistance training (2×/week) program for 12 weeks. Maximal isometric voluntary contraction (MIVC) of knee extensors, muscle thickness (MT) of knee extensors and elbow flexors, rectus femoris muscle quality (MQ), body composition (as measured by DXA) and functional capacity [as measured by 30-s sit-to-stand (30ss) and timed-up-and-go tests (TUG)] were evaluated at baseline and after the 12-week intervention.
RESULTS


Knee extensor MIVC (WP ∆ = 11.9 ± 11.4% and PL ∆ = 12.9 ± 9.9%) was significantly increased over time, with no between-group differences (all p < 0.05 for main effect of time). Upper- and lower-limb MT were significantly increased over time, with no effect of supplementation (WP: ∆ = 7.0 ± 7.3%, PL: ∆ = 9.5 ± 10.3%; and WP: ∆ = 4.5 ± 5.8%, PL: ∆ = 14.7 ± 28.9%, respectively; all p = 0.001 for main effect of time, respectively). Total and upper-limb lean mass were significantly increased, irrespective of the dietary intervention (WP: ∆ = 0.2 ± 6.3%, PL: ∆ = 1.8 ± 2.9%; and WP: ∆ = 0.10 ± 0.03%, PL: ∆ = 0.15 ± 0.02%, respectively; all p < 0.05 for main effect of time). Main effects of time (all p < 0.05) were also found for 30SS and TUG (fast and usual speeds) (WP: ∆ = 18.2 ± 34.4%, PL: ∆ = 10.4 ± 16.9%; WP: ∆ = 5.4 ± 6.7%, PL: ∆ = 0.7 ± 6.0% and WP: ∆ = 3.3 ± 6.1%, PL: ∆ = 2.3 ± 5.2%, respectively).
CONCLUSION


Supplementing additional whey protein to the lowest-protein containing meals (i.e., ~20 g at breakfast and ~20 g at dinner, daily) did not further augment resistance training-induced neuromuscular adaptations (i.e. muscle strength and mass) in healthy older individuals.",2022,Main effects of time (all p < 0.05) were also found for 30SS and TUG (fast and usual speeds) (,"['healthy older individuals', 'older individuals undergoing resistance training', 'older adults', 'Thirty-one male and female older individuals (60 to 80\u202fyears']","['supplementing protein to the low-protein containing meals', 'whey protein/WP (n\u202f=\u202f15, 20\u202fg at breakfast\u202f+\u202f20\u202fg at dinner) or placebo-maltodextrin/PL', 'progressive resistance training (2×/week) program']","['muscle mass, strength, and functional capacity', 'Total and upper-limb lean mass', '30SS and TUG (fast and usual speeds) ', 'Upper- and lower-limb MT', 'Maximal isometric voluntary contraction (MIVC) of knee extensors, muscle thickness (MT) of knee extensors and elbow flexors, rectus femoris muscle quality (MQ), body composition (as measured by DXA) and functional capacity [as measured by 30-s sit-to-stand (30ss) and timed-up-and-go tests (TUG']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",31.0,0.0403139,Main effects of time (all p < 0.05) were also found for 30SS and TUG (fast and usual speeds) (,"[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'de Azevedo Bach', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil. Electronic address: simonebach@gmail.com.'}, {'ForeName': 'Régis', 'Initials': 'R', 'LastName': 'Radaelli', 'Affiliation': 'Neuromuscular Research Lab, Faculty of Human Kinetics, University of Lisbon, Cruz Quebrada Dafundo, Portugal.'}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'Schemes', 'Affiliation': 'Strength Training Research Group, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Neske', 'Affiliation': 'Strength Training Research Group, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Charlles Garbelotto', 'Initials': 'CG', 'LastName': 'Pires', 'Affiliation': 'Nutrition Course, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'Applied Physiology and Nutrition Group, School of Physical Education and Sport, Division of Rheumatology, Faculty of Medicine, FMUSP, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Ronei Silveira', 'Initials': 'RS', 'LastName': 'Pinto', 'Affiliation': 'Strength Training Research Group, School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Cláudia Dornelles', 'Initials': 'CD', 'LastName': 'Schneider', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2022.111760']
3164,35240260,"MicroRNA levels in hemodialysis patients following resistance training: Associations with functional performance, inflammatory profile, sestrins-2, and nitric oxide.","OBJECTIVE


Investigate the effects of long-term resistance training (RT) on expression of the four selected microRNAs (miRNA or mir) and further association with biomarkers related to functional performance in older end-stage renal disease (ESRD) patients undergoing hemodialysis.
METHODS


Twenty-five older hemodialysis patients (glomerular filtration rate <15 mL/min/1.73 m 2  aged 68.28 ± 1.06) were recruited for the study. Patients were allocated to two groups (control, n = 12 and RT, n = 13). The RT group completed 24 weeks of training, with sessions held three times per week on alternate days. Blood samples were collected pre- and post- intervention for miRNA and biochemical assays. Results were considered significant at P < 0.05.
RESULTS


RT promoted benefits in inflammatory profile, nitric oxide, sestrins-2, anthropometric data, and functional performance. Trained subjects presented a 51% decrease in miRNA-31 after intervention. In addition, miRNA-1 increased 128% after RT protocol. miRNA-1 significantly correlated with functional performance, inflammatory profile, sestrins-2, and nitric oxide (all P < 0.05).
CONCLUSIONS


These results suggest that the upregulation of miRNA-1 could be associated with physiological benefits promoted by RT in hemodialysis patients, providing novel understanding for potential regulatory miRNA effects on physiological RT response. These findings might point out to strategic direction for future studies.",2022,"RESULTS


RT promoted benefits in inflammatory profile, nitric oxide, sestrins-2, anthropometric data, and functional performance.","['older end-stage renal disease (ESRD) patients undergoing hemodialysis', 'hemodialysis patients following resistance training', 'hemodialysis patients', '15\u202fmL/min/1.73\u202fm 2  aged 68.28\u202f±\u202f1.06) were recruited for the study', 'Twenty-five older hemodialysis patients (glomerular filtration rate']",['long-term resistance training (RT'],"['inflammatory profile, nitric oxide, sestrins-2, anthropometric data, and functional performance', 'functional performance, inflammatory profile, sestrins-2, and nitric oxide']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4708781', 'cui_str': '1.06'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",25.0,0.0127686,"RESULTS


RT promoted benefits in inflammatory profile, nitric oxide, sestrins-2, anthropometric data, and functional performance.","[{'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'de Luca Corrêa', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Rodrigo Vanerson Passos', 'Initials': 'RVP', 'LastName': 'Neves', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Lysleine Alves', 'Initials': 'LA', 'LastName': 'Deus', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Andrea Lucena', 'Initials': 'AL', 'LastName': 'Reis', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Artur Raab', 'Initials': 'AR', 'LastName': 'Oppelt', 'Affiliation': 'Department of Medicine, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Paolo Lucas', 'Initials': 'PL', 'LastName': 'Rodrigues-Silva', 'Affiliation': 'Biotechnology Research Institute, Chinese Academy of Agricultural Sciences, Beijing 100081, China.'}, {'ForeName': 'Jessica Mycaelle Silva', 'Initials': 'JMS', 'LastName': 'Barbosa', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Thais Branquinho', 'Initials': 'TB', 'LastName': 'de Araújo', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Marcelo Guido Silveira', 'Initials': 'MGS', 'LastName': 'da Silva', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Carlos Ernesto Santos', 'Initials': 'CES', 'LastName': 'Ferreira', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Herbert Gustavo', 'Initials': 'HG', 'LastName': 'Simões', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Octavio Luiz', 'Initials': 'OL', 'LastName': 'Franco', 'Affiliation': 'Centro de Análises Proteômicas e Bioquímicas, Pós-graduação em Ciências Genômicas e Biotecnologia, Universidade Católica de Brasília, Brasília, DF, Brazil; S-Inova Biotech, Pós-graduação em Biotecnologia, Universidade Católica Dom Bosco, Campo Grande, MS, Brazil.'}, {'ForeName': 'Rosângela Vieira', 'Initials': 'RV', 'LastName': 'Andrade', 'Affiliation': 'Graduate Program of Genomic Sciences and Biotechnology, Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Dos Santos Rosa', 'Affiliation': 'Graduate Program of Physical Education, Catholic University of Brasilia, Federal District, Brazil. Electronic address: thiago.rosa@p.ucb.br.'}]",Experimental gerontology,['10.1016/j.exger.2022.111761']
3165,35240703,A Randomized Control Trial of Meditation for Mothers Pumping Breastmilk for Preterm Infants.,"OBJECTIVE


Mothers of preterm infants face unique challenges in establishing milk supply. We hypothesized that daily meditation practice while pumping would increase milk volume.
STUDY DESIGN


This was a randomized control trial examining the effect of meditation on the breastmilk supply of women delivering preterm infants. The meditation group engaged in daily use of a mindfulness-focused meditation app in addition to routine lactation support. The primary outcome was mean breastmilk volume on the infant's 9th day of life. Secondary outcomes included use of lactation-promoting behaviors, continuation of breastfeeding and measures of mental health and breastfeeding self-efficacy by validated questionnaires. A per protocol analysis examined the association of frequent meditation with these breastfeeding and mental health outcomes.
RESULTS


Sixty women were analyzed. Mean milk volume was 647.1 ± 467.8 mL in the meditation group and 514.9 ± 393.5 mL in the routine care group (P = 0.27). Median number of pumping sessions was 7 (IQR 5-8) in the meditation group, compared to 6 (IQR 4-7) in the routine care group (P = 0.11). Other lactation-promoting behaviors, breastfeeding continuation and questionnaire scores were similar. Adjusting for confounders, we found an increase in breastmilk production of 223.2 mL (95% CI 98.8 - 347.5, P = 0.001) and in pumping episodes by 0.93 (95% CI 0.16 - 1.70, P = 0.020) associated with frequent meditation. Skin-to-skin contact was increased to 100% (P = 0.006) among women who meditated seven or more times. Adjusted odds of a clinically significant Edinburgh Postnatal Depression Scale score of > 9 was 0.057 (95% CI 0.0014- 0.711, P = 0.023) with frequent meditation.
CONCLUSION


Breastmilk production was similar in mothers practicing meditation compared to those receiving routine lactation support. For women engaging in frequent mediation, there may be an effect in establishing breastmilk supply and reduction of depression symptoms.",2022,Skin-to-skin contact was increased to 100% (P = 0.006) among women who meditated seven or more times.,"['Mothers of preterm infants', 'Sixty women were analyzed', 'women delivering preterm infants', 'Mothers Pumping Breastmilk for Preterm Infants']","['meditation group engaged in daily use of a mindfulness-focused meditation app', 'meditation', 'Meditation']","['Edinburgh Postnatal Depression Scale score', 'Mean milk volume', 'lactation-promoting behaviors, breastfeeding continuation and questionnaire scores', 'use of lactation-promoting behaviors, continuation of breastfeeding and measures of mental health and breastfeeding self-efficacy by validated questionnaires', 'Median number of pumping sessions', 'milk volume', 'breastmilk production', 'pumping episodes', 'Breastmilk production', 'Skin-to-skin contact', ""mean breastmilk volume on the infant's 9th day of life""]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",60.0,0.0497634,Skin-to-skin contact was increased to 100% (P = 0.006) among women who meditated seven or more times.,"[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Massa', 'Affiliation': 'Washington University in St Louis, St Louis, United States.'}, {'ForeName': 'Soumya', 'Initials': 'S', 'LastName': 'Ramireddy', 'Affiliation': 'School of Medicine, Saint Louis University, Saint Louis, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ficenec', 'Affiliation': 'University of Washington, Seattle, United States.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Mank', 'Affiliation': 'Department of Obstetrics and Gyncology, Saint Louis University, Saint Louis, United States.'}, {'ForeName': 'Justin B', 'Initials': 'JB', 'LastName': 'Josephsen', 'Affiliation': 'Department of Pediatrics, Saint Louis University, Saint Louis, United States.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Babbar', 'Affiliation': 'Maternal-Fetal Medicine, Obstetrics and Gynecology, University of Missouri Kansas City School of Medicine, Kansas City, United States.'}]",American journal of perinatology,['10.1055/a-1787-7576']
3166,35240678,Automated Office Blood Pressure and the Impact of Attendance and Rest on Diagnostic Accuracy.,"BACKGROUND


Automated office blood pressure (AOBP) using three to five measurements taken with an oscillometric device with or without an attendant in the room may decrease ""white coat"" effect. We evaluated the impact of the presence or absence of the attendant and rest on BP and diagnosis of hypertension.
METHODS


We randomly assigned 133 adults aged 18-85 with high BP at baseline (≥140/90 mmHg), no hypertensive diagnosis and no antihypertensive medications to either attended AOBP first, unattended second, or unattended AOBP first, attended second. Outcomes included within-person BP difference for attended versus unattended measurements; 5 minutes versus 15 minutes of rest; and the diagnostic performance of AOBP compared to daytime automated blood pressure measurement (ABPM).
RESULTS


We found no significant differences between attended and unattended AOBP (mean difference attended - unattended [95% confidence interval], systolic 0.14 mmHg[[-0.78, 1.06]; diastolic, 0.16 mmHg[-0.45, 0.78]) or by rest time (mean difference 15-minutes - 5minutes [95%CI], systolic -0.45 mmHg[-1.36, 0.47]; diastolic 0.61 mmHg[-1.23, 0.003]). AOBP was lower than mean daytime ABPM, regardless of attendance or rest (after 5 minutes rest systolic -3.6 and diastolic -2.55 mm Hg, P=.001 for both comparisons). Using daytime ABPM of ≥135/85 mmHg as the diagnostic threshold, AOBP sensitivity and specificity after 5 minutes of rest was 71.0% and 54.1% respectively.
CONCLUSIONS


The presence or absence of a clinic attendant during AOBP measurement and the amount of rest time before AOBP measurements had no effects on BP. AOBP measurements have low sensitivity and specificity for making a new diagnosis of hypertension.",2022,"We found no significant differences between attended and unattended AOBP (mean difference attended - unattended [95% confidence interval], systolic 0.14 mmHg[[-0.78, 1.06];",['133 adults aged 18-85 with high BP at baseline (≥140/90 mmHg'],[],"['diagnostic threshold, AOBP sensitivity and specificity', 'mean daytime ABPM, regardless of attendance or rest', 'BP', 'no hypertensive diagnosis and no antihypertensive medications', 'AOBP', 'diagnostic performance of AOBP', 'daytime automated blood pressure measurement (ABPM', 'unattended AOBP']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",133.0,0.181718,"We found no significant differences between attended and unattended AOBP (mean difference attended - unattended [95% confidence interval], systolic 0.14 mmHg[[-0.78, 1.06];","[{'ForeName': 'B B', 'Initials': 'BB', 'LastName': 'Green', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Anderson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Cook', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ehrlich', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute.'}, {'ForeName': 'Y N', 'Initials': 'YN', 'LastName': 'Hall', 'Affiliation': 'Kidney Research Institute, University of Washington, Department of Medicine.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Margolis', 'Affiliation': 'HealthPartners Institute.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Thompson', 'Affiliation': 'University of Washington, Department of Family Medicine.'}]",American journal of hypertension,['10.1093/ajh/hpac032']
3167,35240966,Hydroxychloroquine (HCQ) treatment for hospitalized patients with COVID- 19.,"OBJECTIVE


Studies have indicated that hydroxychloroquine (HCQ) exerts antiviral effects against SARS-CoV-2 in vitro. However, trials regarding its effects in patients are very controversial. This study aims to evaluate the efficacy of (HCQ) in the treatment of hospitalized patients with COVID-19.
METHODS


We prospectively enrolled 260 patients hospitalized for COVID-19 in Heart and Brain Center of Excellence- Pleven, Bulgaria, for the period from November 6 to December 28, 2020. This study is not randomized, which we compensated for with Propensity Score Matching. Patients in the HCQ group were given HCQ 200 mg 3 times a day (600mg daily) for the duration of their hospitalization plus conventional treatment, while those in the control group were given conventional treatment only. The primary endpoints were transferred to the intensive care unit, needed for mechanical ventilation, and in-hospital death.
RESULTS


Of the 260 COVID-19 patients, 178 (68,5%) were male and the mean age was of 63,78 ± 12.45 years, with the most prevalent comorbidity hypertension (68,5%). We had two subgroups: treated with HCQ and conventional treatment (128 patients) and treated with conventional treatment only (132 patients). In the primary analysis, patients in HCQ group presented with less comorbidities and were younger than the group without HCQ. Patients treated with HCQ demonstrated a significant benefit in the primary endpoints compared to those without HCQ, namely, transferred to ICU - 20 (20,8%) vs 41 (36,9%), p=0,011, need for mechanical ventilation 13 (13,4%) vs 33 (28,2%), p=0,009 and in- hospital death 14 (10,9%) vs 35 (26,5%), p=0,001, respectively. We repeated this analysis with PSM, where 70 matched pairs were identified. Regarding the primary endpoints, we found again a statistically significant difference between the groups. Comparing transferring to ICU, better outcomes were presented in the HCQ group: 8 (17,4%) vs 27 (44,3%), with p= 0,003. Besides, a smaller proportion of the patients needed mechanical ventilation: 6 (12,8%), compared to the control group, 23 (35,4%), p= 0,007. Notably, patients from the HCQ group died during hospitalization: 8 (11,4%) in comparison with 19 (27,1%) from the control group, p= 0,018.
CONCLUSION


Patients treated with HCQ demonstrated a significant benefit in the primary endpoints in our study, namely, transfer to the intensive care unit, need for mechanical ventilation, and in-hospital death. HCQ improves prognosis in hospitalized patients with COVID- 19.",2022,"Comparing transferring to ICU, better outcomes were presented in the HCQ group: 8 (17,4%) vs 27 (44,3%), with p= 0,003.","['hospitalized patients with COVID- 19', 'Of the 260 COVID-19 patients, 178 (68,5%) were male and the mean age was of 63,78 ± 12.45 years, with the most prevalent comorbidity hypertension (68,5', 'hospitalized patients with COVID-19', '260 patients hospitalized for COVID-19 in Heart and Brain Center of Excellence', '128 patients) and treated with conventional treatment only (132 patients']","['Hydroxychloroquine (HCQ', 'HCQ', 'HCQ and conventional treatment', 'hydroxychloroquine (HCQ']","['namely, transfer to the intensive care unit, need for mechanical ventilation, and in-hospital death', 'in- hospital death', 'transferred to the intensive care unit, needed for mechanical ventilation, and in-hospital death']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",260.0,0.0433561,"Comparing transferring to ICU, better outcomes were presented in the HCQ group: 8 (17,4%) vs 27 (44,3%), with p= 0,003.","[{'ForeName': 'Hristina', 'Initials': 'H', 'LastName': 'Tsanovska', 'Affiliation': 'Heart and Brain-University Hospital, Pleven, Bulgaria.'}, {'ForeName': 'Iana', 'Initials': 'I', 'LastName': 'Simova', 'Affiliation': 'Heart and Brain-University Hospital, Pleven, Bulgaria | Bulgarian Cardiac Institute | Medical University, Pleven, Bulgaria.'}, {'ForeName': 'Vladislav', 'Initials': 'V', 'LastName': 'Genov', 'Affiliation': 'Heart and Brain-University Hospital, Pleven, Bulgaria.'}, {'ForeName': 'Todor', 'Initials': 'T', 'LastName': 'Kundurzhiev', 'Affiliation': 'Medical University, Sofia, Bulgaria.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Krasnaliev', 'Affiliation': 'Heart and Brain-University Hospital, Pleven, Bulgaria.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Kornovski', 'Affiliation': 'Heart and Brain Hospital, Burgas, Bulgaria.'}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Dimitrov', 'Affiliation': 'Heart and Brain-University Hospital, Pleven, Bulgaria; | Medical University, Pleven, Bulgaria | Heart and Brain Hospital, Burgas, Bulgaria.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Vekov', 'Affiliation': 'Bulgarian Cardiac Institute | Medical University, Pleven, Bulgaria.'}]",Infectious disorders drug targets,['10.2174/1871526522666220303121209']
3168,35240951,Effects of Gender Stereotypes on Balance Performance and Learning in Men.,"The purpose of this study was to examine the effects of gender stereotypes on the performance and learning of a balance task in men. Before practice, forty-eight participants received instructions involving the comparison of balance between males and females: males normally perform worse than females (stereotype threat condition - ST), females usually perform worse than males (stereotype lift condition - SL), or no instructions regarding gender stereotypes (control condition). One day later, they performed a retention test. The results show that the SL group outperformed the other groups during practice, but not retention. ST participants reported lower perceived competence. The findings show that gender stereotypes can affect perceptions of competence and balance performance, but not balance learning, in men.",2022,"The findings show that gender stereotypes can affect perceptions of competence and balance performance, but not balance learning, in men.","['Men', 'men', 'between males and females: males normally perform worse than females (stereotype threat condition - ST), females usually perform worse than males (stereotype lift condition - SL), or no instructions regarding gender stereotypes (control condition']","['instructions involving the comparison of balance', 'Gender Stereotypes', 'SL']",['Balance Performance and Learning'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",48.0,0.0379842,"The findings show that gender stereotypes can affect perceptions of competence and balance performance, but not balance learning, in men.","[{'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'Cardozo', 'Affiliation': 'Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Aïna', 'Initials': 'A', 'LastName': 'Chalabaev', 'Affiliation': 'University of Grenoble-Alpes, Grenoble, France.'}, {'ForeName': 'Suzete', 'Initials': 'S', 'LastName': 'Chiviacowsky', 'Affiliation': 'Federal University of Pelotas, Pelotas, Brazil.'}]",Journal of motor behavior,['10.1080/00222895.2022.2045248']
3169,35237953,Continuous interscalene versus phrenic nerve-sparing high-thoracic erector spinae plane block for total shoulder arthroplasty: a randomized controlled trial.,"PURPOSE


The high-thoracic erector spinae plane block (HT-ESPB) has been reported as an effective analgesic modality for the shoulder region without phrenic nerve palsy. The goal of this study was to compare the HT-ESPB as a phrenic nerve-sparing alternative to an interscalene block for total shoulder arthroplasty.
METHODS


Thirty patients undergoing total shoulder arthroplasty at Stanford Health Care (Palo Alto, CA, USA) were enrolled in a double-blind randomized controlled trial. We randomized 28 patients to receive either an interscalene or HT-ESPB perineural catheter preoperatively; 26 patients were included in the final analysis. The study was powered for the primary outcome of incidence of hemidiaphragmatic paralysis in the postanesthesia care unit (PACU). Other outcome measures included incentive spirometry volume, brachial plexus motor and sensory exams, adverse events, pain scores, and opioid consumption.
RESULTS


The incidence of hemidiaphragmatic paralysis in the HT-ESPB catheter group was significantly lower than in the interscalene catheter group (0/12, 0% vs 14/14, 100%; P < 0.001). No statistically significant differences were found in pain scores and opioid consumption (in oral morphine equivalents) between the interscalene and HT-ESPB groups through postoperative day (POD) 2. Nevertheless, the mean (standard deviation) point estimates for opioid consumption for the HT-ESPB group were higher than for the interscalene group in the PACU (HT-ESPB: 24.8 [26.7] mg; interscalene: 10.7 [21.7] mg) and for POD 0 (HT-ESPB: 20.5 [25.0] mg; interscalene: 6.7 [12.0] mg). In addition, cumulative postoperative opioid consumption was significantly higher at POD 0 (PACU through POD 0) in the HT-ESPB group (45.3 [39.9] mg) than in the interscalene group (16.6 [21.9] mg; P = 0.04).
CONCLUSIONS


This study suggests that continuous HT-ESPB can be a phrenic nerve-sparing alternative to continuous interscalene brachial plexus blockade, although the latter provided superior opioid-sparing in the immediate postoperative period. This was a small sample size study, and further investigations powered to detect differences in analgesic and quality of recovery score endpoints are needed.
STUDY REGISTRATION


www.ClinicalTrials.gov (NCT03807505); registered 17 January 2019.",2022,No statistically significant differences were found in pain scores and opioid consumption (in oral morphine equivalents) between the interscalene and HT-ESPB groups through postoperative day (POD) 2.,"['28 patients to receive either an interscalene or HT-ESPB perineural catheter preoperatively; 26 patients were included in the final analysis', 'Thirty patients undergoing total shoulder arthroplasty at Stanford Health Care (Palo Alto, CA, USA', 'total shoulder arthroplasty']","['Continuous interscalene versus phrenic nerve-sparing high-thoracic erector spinae plane block', 'HT-ESPB', 'interscalene catheter', 'continuous HT-ESPB']","['opioid consumption', 'cumulative postoperative opioid consumption', 'incentive spirometry volume, brachial plexus motor and sensory exams, adverse events, pain scores, and opioid consumption', 'incidence of hemidiaphragmatic paralysis', 'pain scores and opioid consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589495', 'cui_str': 'Interscalene approach'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0186657', 'cui_str': 'Total shoulder replacement'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0589495', 'cui_str': 'Interscalene approach'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0006090', 'cui_str': 'Brachial plexus structure'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237766', 'cui_str': 'Hysterical paralysis'}]",28.0,0.263548,No statistically significant differences were found in pain scores and opioid consumption (in oral morphine equivalents) between the interscalene and HT-ESPB groups through postoperative day (POD) 2.,"[{'ForeName': 'Lisa Y', 'Initials': 'LY', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Shruthi', 'Initials': 'S', 'LastName': 'Basireddy', 'Affiliation': 'Loyola University Chicago, Stritch School of Medicine, Maywood, USA.'}, {'ForeName': 'Lynn Ngai', 'Initials': 'LN', 'LastName': 'Gerber', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford University Medical Center, 300 Pasteur Drive, Rm H3580, Stanford, CA, 94305, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lamano', 'Affiliation': 'Loyola University Chicago, Stritch School of Medicine, Maywood, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Costouros', 'Affiliation': 'Institute for Joint Restoration, Dearborn & Associates, Menlo Park, CA, USA.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Cheung', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Boublik', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford University Medical Center, 300 Pasteur Drive, Rm H3580, Stanford, CA, 94305, USA.'}, {'ForeName': 'Jean Louis', 'Initials': 'JL', 'LastName': 'Horn', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford University Medical Center, 300 Pasteur Drive, Rm H3580, Stanford, CA, 94305, USA.'}, {'ForeName': 'Ban C H', 'Initials': 'BCH', 'LastName': 'Tsui', 'Affiliation': 'Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford University Medical Center, 300 Pasteur Drive, Rm H3580, Stanford, CA, 94305, USA. bantsui@stanford.edu.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-022-02216-1']
3170,35238084,Non-surgical peri-implantitis treatment with or without systemic antibiotics; a randomized controlled clinical trial.,"OBJECTIVES


To assess the adjunctive effect of systemic amoxicillin (AMX) and metronidazole (MTZ) in patients receiving non-surgical treatment (NST) for peri-implantitis (PI).
MATERIALS AND METHODS


Thirty-seven patients were randomized into an experimental group treated with NST plus AMX + MTZ (N=18) and a control group treated with NST alone (N=19). Clinical parameters were evaluated at 12 weeks post-treatment. The primary outcome was the change in peri-implant pocket depth (PIPD) from baseline to 12 weeks, while secondary outcomes included bleeding on probing (BoP), suppuration on probing (SoP) and plaque. Data analysis was performed at patient level (one target site per patient).
RESULTS


All 37 patients completed the study. Both groups showed a significant PIPD reduction after NST. The antibiotics group showed a higher mean reduction of PIPD at 12 weeks, compared with the control group (2.28 ± 1.49 mm vs 1.47 ± 1.95 mm), however this difference did not reach statistical significance. There was no significant effect of various potential confounders on PIPD reduction. Neither treatment resulted in significant improvements in BoP at follow-up; thirty out of 37 (81%) target sites still had BoP after treatment. Only two implants, one in each group, exhibited a successful outcome defined as PIPD ≤5 mm, and absence of BoP and SoP.
CONCLUSIONS


NST was able to reduce PIPD at implants with PI. The adjunctive use of systemic AMX and MTZ did not show statistically significant better results compared to NST alone. NST with or without antibiotics was ineffective to completely resolve inflammation around dental implants.",2022,The adjunctive use of systemic AMX and MTZ did not show statistically significant better results compared to NST alone.,"['Thirty-seven patients', 'patients receiving non-surgical treatment (NST) for peri-implantitis (PI', 'All 37 patients completed the study']","['NST with or without antibiotics', 'NST', 'surgical peri-implantitis treatment with or without systemic antibiotics', 'systemic amoxicillin (AMX) and metronidazole (MTZ', 'NST plus AMX + MTZ', 'control group treated with NST alone']","['PIPD reduction', 'mean reduction of PIPD', 'change in peri-implant pocket depth (PIPD', 'BoP', 'bleeding on probing (BoP), suppuration on probing (SoP) and plaque']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0038862', 'cui_str': 'Suppurative inflammation'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}]",37.0,0.0748912,The adjunctive use of systemic AMX and MTZ did not show statistically significant better results compared to NST alone.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Polymeri', 'Affiliation': 'Department of Periodontology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and VU Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Horst', 'Affiliation': 'Department of Oral Implantology and Prosthetic Dentistry, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and VU Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Anssari Moin', 'Affiliation': 'Department of Periodontology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and VU Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wismeijer', 'Affiliation': 'Department of Oral Implantology and Prosthetic Dentistry, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and VU Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'B G', 'Initials': 'BG', 'LastName': 'Loos', 'Affiliation': 'Department of Periodontology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and VU Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Laine', 'Affiliation': 'Department of Periodontology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and VU Amsterdam, Amsterdam, the Netherlands.'}]",Clinical oral implants research,['10.1111/clr.13914']
3171,35238041,Comparative evaluation of 1% melatonin gel in the treatment of intrabony defect: A randomized controlled clinical trial.,"BACKGROUND


The present study was aimed to evaluate and compare the efficacy of locally delivered 1% Melatonin gel as an adjunct to Nonsurgical Periodontal Therapy (NSPT) in treatment of intrabony defect in Stage III periodontitis, clinically and radiographically using Cone Beam computed tomography (CBCT).
MATERIAL AND METHODS


This split-mouth clinical trial randomly allotted 44 bilateral intrabony defect (in 22 patients) into two groups were Group I was treated with NSPT with locally delivered placebo gel while Group II was treated with NSPT with 1% Melatonin gel. The primary outcome parameters measured were the intrabony defect fill measured from cement enamel junction (CEJ)- base of the defect (BD), and the difference in the measurement values of CEJ -BD from baseline to 6 month denotes the bone fill and bone volume evaluated at 6 month using CBCT while, secondary outcome being change in probing pocket depth (PPD), Clinical attachment level (CAL) plaque index (PI) and modified sulcus bleeding index (mSBI) recorded at baseline, 3 and 6 months.
RESULTS


Both the study groups showed improvements in assessed parameters however, a significant gain in intrabony defect fill was observed in Group II (1.46 ± 0.58) as compared to Group I (0.50 ± 0.38) and change in bone volume for Group I was 21.4645 ± 8.8980 mm 3  and for Group II was 51.8418 ± 30.2329 mm 3  with p <0.0001.The mean reduction in PPD and gain in CAL was 3.90 ± 0.78 and 2.94 ± 0.80 in Group II and in Group I it was 3.23 ± 0.90 and 1.96 ± 0.80 (p<0.0001).
CONCLUSION


The use of 1% Melatonin gel as an adjunct to NSPT is more beneficial in achieving better clinical and radiographic outcome at 6 months indicates that adjunct use of melatonin gel to NSPT as a Local drug delivery (LDD) holds upper hands when compared to NSPT and Placebo gel alone. This article is protected by copyright. All rights reserved.",2022,The use of 1% Melatonin gel as an adjunct to NSPT is more beneficial in achieving better clinical and radiographic outcome at 6 months indicates that adjunct use of melatonin gel to NSPT as a Local drug delivery (LDD) holds upper hands when compared to NSPT and Placebo gel alone.,['intrabony defect'],"['melatonin gel to NSPT', 'NSPT with 1% Melatonin gel', 'NSPT with locally delivered placebo gel', 'Nonsurgical Periodontal Therapy (NSPT', 'Melatonin gel', 'melatonin gel']","['probing pocket depth (PPD), Clinical attachment level (CAL) plaque index (PI) and modified sulcus bleeding index (mSBI', 'change in bone volume', 'intrabony defect fill measured from cement enamel junction (CEJ)- base of the defect (BD), and the difference in the measurement values of CEJ -BD', 'PPD and gain in CAL', 'significant gain in intrabony defect fill', 'bone fill and bone volume']","[{'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",44.0,0.036749,The use of 1% Melatonin gel as an adjunct to NSPT is more beneficial in achieving better clinical and radiographic outcome at 6 months indicates that adjunct use of melatonin gel to NSPT as a Local drug delivery (LDD) holds upper hands when compared to NSPT and Placebo gel alone.,"[{'ForeName': 'Noopur P', 'Initials': 'NP', 'LastName': 'Gonde', 'Affiliation': 'Department of Periodontics & Implantology, VSPM Dental College and Research Centre, Nagpur, India.'}, {'ForeName': 'Surekha R', 'Initials': 'SR', 'LastName': 'Rathod', 'Affiliation': 'Department of Periodontics & Implantology, VSPM Dental College and Research Centre, Nagpur, India.'}, {'ForeName': 'Abhay P', 'Initials': 'AP', 'LastName': 'Kolte', 'Affiliation': 'Department of Periodontics & Implantology, VSPM Dental College and Research Centre, Nagpur, India.'}]",Journal of periodontology,['10.1002/JPER.21-0515']
3172,35238013,The effect of opioid-free anesthesia on the post-operative opioid consumption in laparoscopic bariatric surgeries: A randomized controlled double-blind study.,"OBJECTIVE


This study aimed to evaluate the ability to use opioid-free anesthesia (OFA) technique in morbid obese patients.
DESIGN


A prospective randomized double-blinded study.
SETTING


This study was carried out at Tanta University Hospitals (tertiary hospitals).
PATIENTS


Eighty morbid obese patients scheduled for laparoscopic bariatric surgeries.
INTERVENTION


Patients were allocated randomly into two groups: Group C, in which fentanyl was used during induction and maintenance of anesthesia, and group OFA, in which dexmedetomidine, ketamine, magnesium, and lidocaine were started before the induction of anesthesia and continued throughout the surgery.
MAIN OUTCOME MEASURE


The post-operative morphine consumption in the first 24 hours (primary outcome) and the intraoperative fentanyl consumption (secondary outcome).
RESULTS


In comparison to the control group, OFA technique significantly decreased the post-operative morphine consumption (p = 0.003; 95 percent CI: 0.505; 2.396), shortened the time for the first request of rescue analgesia (p < 0.0001; 95 percent CI: 54.14; 99.11), decreased the post-operative pain score 4 and 6 hours after surgery (p < 0.05), and decreased the post-operative nausea and vomiting (PONV) impact scale (p = 0.022). Furthermore, it significantly decreased the intraoperative fentanyl consumption (p < 0.0001) with the improvement of all parameters of the recovery profile (p < 0.05).
CONCLUSION


OFA in patients undergoing bariatric surgeries significantly decreased the post-operative morphine consumption, the post-operative pain score, the intraoperative fentanyl consumption, and the PONV impact scale with the improvement of the recovery profile.",2022,"OFA in patients undergoing bariatric surgeries significantly decreased the post-operative morphine consumption, the post-operative pain score, the intraoperative fentanyl consumption, and the PONV impact scale with the improvement of the recovery profile.","['Eighty morbid obese patients scheduled for laparoscopic bariatric surgeries', 'Tanta University Hospitals (tertiary hospitals', 'morbid obese patients', 'laparoscopic bariatric surgeries']","['opioid-free anesthesia', 'dexmedetomidine, ketamine, magnesium, and lidocaine', 'opioid-free anesthesia (OFA) technique', 'OFA']","['post-operative morphine consumption', 'post-operative nausea and vomiting (PONV) impact scale', 'post-operative morphine consumption, the post-operative pain score, the intraoperative fentanyl consumption, and the PONV impact scale', 'intraoperative fentanyl consumption (secondary outcome', 'intraoperative fentanyl consumption', 'post-operative pain score']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.252616,"OFA in patients undergoing bariatric surgeries significantly decreased the post-operative morphine consumption, the post-operative pain score, the intraoperative fentanyl consumption, and the PONV impact scale with the improvement of the recovery profile.","[{'ForeName': 'Sameh Abdelkhalik', 'Initials': 'SA', 'LastName': 'Ahmed', 'Affiliation': 'Assistant Professor at the Department of Anesthesiology and Intensive Care, Faculty of Medicine, Tanta University, Egypt. ORCID: https://orcid.org/0000-0001-8804-6959.'}, {'ForeName': 'Mohamed Shebl', 'Initials': 'MS', 'LastName': 'Abdelghany', 'Affiliation': 'Lecturer at the Department of Anesthesiology and Intensive Care, Faculty of Medicine, Tanta University, Egypt.'}, {'ForeName': 'Mohamed Elsayed', 'Initials': 'ME', 'LastName': 'Afandy', 'Affiliation': 'Lecturer at the Department of Anesthesiology and Intensive Care, Faculty of Medicine, Tanta University, Egypt.'}]",Journal of opioid management,['10.5055/jom.2022.0694']
3173,35238404,Arthroscopic surgery for degenerative knee disease (osteoarthritis including degenerative meniscal tears).,"BACKGROUND


Arthroscopic knee surgery remains a common treatment for symptomatic knee osteoarthritis, including for degenerative meniscal tears, despite guidelines strongly recommending against its use. This Cochrane Review is an update of a non-Cochrane systematic review published in 2017.
OBJECTIVES


To assess the benefits and harms of arthroscopic surgery, including debridement, partial menisectomy or both, compared with placebo surgery or non-surgical treatment in people with degenerative knee disease (osteoarthritis, degenerative meniscal tears, or both).
SEARCH METHODS


We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and two trials registers up to 16 April 2021, unrestricted by language.
SELECTION CRITERIA


We included randomised controlled trials (RCTs), or trials using quasi-randomised methods of participant allocation, comparing arthroscopic surgery with placebo surgery or non-surgical interventions (e.g. exercise, injections, non-arthroscopic lavage/irrigation, drug therapy, and supplements and complementary therapies) in people with symptomatic degenerative knee disease (osteoarthritis or degenerative meniscal tears or both). Major outcomes were pain, function, participant-reported treatment success, knee-specific quality of life, serious adverse events, total adverse events and knee surgery (replacement or osteotomy).
DATA COLLECTION AND ANALYSIS


Two review authors independently selected studies for inclusion, extracted data, and assessed risk of bias and the certainty of evidence using GRADE. The primary comparison was arthroscopic surgery compared to placebo surgery for outcomes that measured benefits of surgery, but we combined data from all control groups to assess harms and knee surgery (replacement or osteotomy).
MAIN RESULTS


Sixteen trials (2105 participants) met our inclusion criteria. The average age of participants ranged from 46 to 65 years, and 56% of participants were women. Four trials (380 participants) compared arthroscopic surgery to placebo surgery. For the remaining trials, arthroscopic surgery was compared to exercise (eight trials, 1371 participants), a single intra-articular glucocorticoid injection (one trial, 120 participants), non-arthroscopic lavage (one trial, 34 participants), non-steroidal anti-inflammatory drugs (one trial, 80 participants) and weekly hyaluronic acid injections for five weeks (one trial, 120 participants). The majority of trials without a placebo control were susceptible to bias: in particular, selection (56%), performance (75%), detection (75%), attrition (44%) and selective reporting (75%) biases. The placebo-controlled trials were less susceptible to bias and none were at risk of performance or detection bias. Here we limit reporting to the main comparison, arthroscopic surgery versus placebo surgery. High-certainty evidence indicates arthroscopic surgery leads to little or no difference in pain or function at three months after surgery, moderate-certainty evidence indicates there is probably little or no improvement in knee-specific quality of life three months after surgery, and low-certainty evidence indicates arthroscopic surgery may lead to little or no difference in participant-reported success at up to five years, compared with placebo surgery. Mean post-operative pain in the placebo group was 40.1 points on a 0 to 100 scale (where lower score indicates less pain) compared to 35.5 points in the arthroscopic surgery group, a difference of 4.6 points better (95% confidence interval (CI) 0.02 better to 9 better; I 2  = 0%; 4 trials, 309 participants). Mean post-operative function in the placebo group was 75.9 points on a 0 to 100 rating scale (where higher score indicates better function) compared to 76 points in the arthroscopic surgery group, a difference of 0.1 points better (95% CI 3.2 worse to 3.4 better; I 2  = 0%; 3 trials, 302 participants). Mean post-operative knee-specific health-related quality of life in the placebo group was 69.7 points on a 0 to 100 rating scale (where higher score indicates better quality of life) compared with 75.3 points in the arthroscopic surgery group, a difference of 5.6 points better (95% CI 0.36 better to 10.68 better; I 2  = 0%; 2 trials, 188 participants). We downgraded this evidence to moderate certainty as the 95% confidence interval does not rule in or rule out a clinically important change. After surgery, 74 out of 100 people reported treatment success with placebo and 82 out of 100 people reported treatment success with arthroscopic surgery at up to five years (risk ratio (RR) 1.11, 95% CI 0.66 to 1.86; I 2  = 53%; 3 trials, 189 participants). We downgraded this evidence to low certainty due to serious indirectness (diversity in definition and timing of outcome measurement) and serious imprecision (small number of events). We are less certain if the risk of serious or total adverse events increased with arthroscopic surgery compared to placebo or non-surgical interventions. Serious adverse events were reported in 6 out of 100 people in the control groups and 8 out of 100 people in the arthroscopy groups from eight trials (RR 1.35, 95% CI 0.64 to 2.83; I 2  = 47%; 8 trials, 1206 participants). Fifteen out of 100 people reported adverse events with control interventions, and 17 out of 100 people with surgery at up to five years (RR 1.15, 95% CI 0.78 to 1.70; I 2  = 48%; 9 trials, 1326 participants). The certainty of the evidence was low, downgraded twice due to serious imprecision (small number of events) and possible reporting bias (incomplete reporting of outcome across studies). Serious adverse events included death, pulmonary embolism, acute myocardial infarction, deep vein thrombosis and deep infection. Subsequent knee surgery (replacement or high tibial osteotomy) was reported in 2 out of 100 people in the control groups and 4 out of 100 people in the arthroscopy surgery groups at up to five years in four trials (RR 2.63, 95% CI 0.94 to 7.34; I 2  = 11%; 4 trials, 864 participants). The certainty of the evidence was low, downgraded twice due to the small number of events.
AUTHORS' CONCLUSIONS


Arthroscopic surgery provides little or no clinically important benefit in pain or function, probably does not provide clinically important benefits in knee-specific quality of life, and may not improve treatment success compared with a placebo procedure. It may lead to little or no difference, or a slight increase, in serious and total adverse events compared to control, but the evidence is of low certainty. Whether or not arthroscopic surgery results in slightly more subsequent knee surgery (replacement or osteotomy) compared to control remains unresolved.",2022,"Subsequent knee surgery (replacement or high tibial osteotomy) was reported in 2 out of 100 people in the control groups and 4 out of 100 people in the arthroscopy surgery groups at up to five years in four trials (RR 2.63, 95% CI 0.94 to 7.34;","['Sixteen trials (2105 participants) met our inclusion criteria', 'Embase, and two trials registers up to 16 April 2021, unrestricted by language', 'people with symptomatic degenerative knee disease (osteoarthritis or degenerative meniscal tears or both', 'degenerative knee disease (osteoarthritis including degenerative meniscal tears', 'people with degenerative knee disease (osteoarthritis, degenerative meniscal tears, or both', 'The average age of participants ranged from 46 to 65 years, and 56% of participants were women']","['Arthroscopic surgery', 'single intra-articular glucocorticoid injection', 'placebo', 'arthroscopic surgery', 'non-steroidal anti-inflammatory drugs', 'arthroscopic surgery to placebo surgery', 'non-arthroscopic lavage', 'Subsequent knee surgery (replacement or high tibial osteotomy', 'arthroscopic surgery with placebo surgery or non-surgical interventions (e.g. exercise, injections, non-arthroscopic lavage/irrigation, drug therapy, and supplements and complementary therapies', 'Arthroscopic knee surgery', 'arthroscopic surgery versus placebo surgery', 'hyaluronic acid injections', 'arthroscopic surgery, including debridement, partial menisectomy or both, compared with placebo surgery or non-surgical treatment']","['pain', 'pain or function', 'treatment success with arthroscopic surgery', 'Mean post-operative pain', 'Mean post-operative knee-specific health-related quality of life', 'serious and total adverse events', 'Mean post-operative function', 'adverse events', 'quality of life', 'Serious adverse events', 'harms and knee surgery (replacement or osteotomy', 'pain, function, participant-reported treatment success, knee-specific quality of life, serious adverse events, total adverse events and knee surgery (replacement or osteotomy', 'death, pulmonary embolism, acute myocardial infarction, deep vein thrombosis and deep infection']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C1290879', 'cui_str': 'Disorder of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0238218', 'cui_str': 'Tear of meniscus of knee'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0750934', 'cui_str': 'Arthroscopy with surgical procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0936077', 'cui_str': 'Complementary therapy'}, {'cui': 'C4082765', 'cui_str': 'Arthroscopic knee operation'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0750934', 'cui_str': 'Arthroscopy with surgical procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",120.0,0.807043,"Subsequent knee surgery (replacement or high tibial osteotomy) was reported in 2 out of 100 people in the control groups and 4 out of 100 people in the arthroscopy surgery groups at up to five years in four trials (RR 2.63, 95% CI 0.94 to 7.34;","[{'ForeName': 'Denise', 'Initials': 'D', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University; Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology, Cabrini Health, Melbourne, Australia.'}, {'ForeName': 'Renea V', 'Initials': 'RV', 'LastName': 'Johnston', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University; Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology, Cabrini Health, Melbourne, Australia.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Brignardello-Petersen', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Rudolf W', 'Initials': 'RW', 'LastName': 'Poolman', 'Affiliation': 'Department of Orthopaedic Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Cyril', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University; Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology, Cabrini Health, Melbourne, Australia.'}, {'ForeName': 'Per O', 'Initials': 'PO', 'LastName': 'Vandvik', 'Affiliation': 'Department of Medicine, Lovisenberg Diaconal Hospital, Oslo, Norway.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Buchbinder', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University; Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology, Cabrini Health, Melbourne, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD014328']
3174,35238873,Efficacy of HD201 vs Referent Trastuzumab in Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting: A Multicenter Phase 3 Randomized Clinical Trial.,"Importance


The drug HD201 is a biosimilar candidate for breast cancer treatment as the reference trastuzumab.
Objective


To compare the efficacy of HD201 with referent trastuzumab.
Design, Setting, and Participants


This randomized clinical trial (TROIKA) included 502 women with ERBB2-positive early breast cancer treated with either HD201 or referent trastuzumab. It was conducted across 70 centers in 12 countries, including Western and Eastern Europe and Asian countries. Randomization was stratified by tumor hormone receptor status, clinical stage, and geographic region of recruitment. This analysis was conducted on February 12, 2021, after the completion of the adjuvant phase at a median of 31 months (IQR, 28-33 months) of follow-up.
Interventions


Patients with ERBB2-positive early breast cancer were randomly assigned to receive HD201 or referent trastuzumab in the neoadjuvant setting for 8 cycles, concurrently with 4 cycles of docetaxel, which was followed by 4 cycles of epirubicin and cyclophosphamide. Patients then underwent surgery, which was followed by treatment with 10 cycles of adjuvant HD201 or referent trastuzumab.
Main Outcome and Measures


The primary end point was the total pathological complete response (tpCR) assessed after neoadjuvant treatment. Equivalence was concluded if the 95% CI of the absolute difference in tpCR between arms in the per-protocol set was within the margin of more or less than 15%. Other objectives included the breast pathological complete response, overall response, event-free and overall survival, safety, pharmacokinetics, and immunogenicity.
Results


A total of 502 female patients (mean [range] age, 53 [26-82] years) were randomized to receive either HD201 or referent trastuzumab, and 474 (94.2%) were eligible for inclusion in the per-protocol set. The baseline characteristics were well balanced between the 2 arms; 195 tumors (38.8%) were hormone receptor-negative , and 213 patients (42.4%) had clinical stage III disease. The tpCR rates were 45% and 48.7% for HD201 and referent trastuzumab, respectively. The difference between the 2 groups was not significant at -3.8% (95% CI, -12.8% to 5.4%) and fell within the predefined equivalence margins. The ratio of the tpCR rates between the 2 arms was 0.92 (95% CI, 0.76 to 1.12). A total of 433 patients (86.1%) presented with 2232 treatment-emergent adverse events of special interest for trastuzumab during the entire treatment period, with 220 (88.0%) and 213 (84.5%) patients in the HD201 and referent trastuzumab groups, respectively.
Conclusions and Relevance


The results of this randomized clinical trial found that HD201 demonstrated equivalence to referent trastuzumab in terms of efficacy for the end point of tpCR, with a similar safety profile.
Trial Registration


ClinicalTrials.gov Identifier: NCT03013504.",2022,"A total of 433 patients (86.1%) presented with 2232 treatment-emergent adverse events of special interest for trastuzumab during the entire treatment period, with 220 (88.0%) and 213 (84.5%) patients in the HD201 and referent trastuzumab groups, respectively.
","['433 patients (86.1%) presented with 2232 treatment-emergent adverse events of special interest for trastuzumab during the entire treatment period, with 220 (88.0%) and 213 (84.5%) patients in the HD201 and referent trastuzumab groups, respectively', '70 centers in 12 countries, including Western and Eastern Europe and Asian countries', '502 female patients (mean [range] age, 53 [26-82] years', '502 women with ERBB2-positive early breast cancer treated with either', 'Interventions\n\n\nPatients with ERBB2-positive early breast cancer', 'Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting']","['HD201 with referent trastuzumab', 'epirubicin and cyclophosphamide', 'adjuvant HD201 or referent trastuzumab', 'HD201 vs Referent Trastuzumab', 'HD201 or referent trastuzumab', 'docetaxel']","['tpCR', 'breast pathological complete response, overall response, event-free and overall survival, safety, pharmacokinetics, and immunogenicity', 'tpCR rates', 'total pathological complete response (tpCR', 'ratio of the tpCR rates', 'clinical stage III disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015177', 'cui_str': 'East European country'}, {'cui': 'C0454705', 'cui_str': 'Asian country'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205578', 'cui_str': 'Clinical stage III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",502.0,0.395272,"A total of 433 patients (86.1%) presented with 2232 treatment-emergent adverse events of special interest for trastuzumab during the entire treatment period, with 220 (88.0%) and 213 (84.5%) patients in the HD201 and referent trastuzumab groups, respectively.
","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pivot', 'Affiliation': 'Institute of Cancer Strasbourg, Strasbourg, France.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Georgievich', 'Affiliation': 'St Petersburg GBUZ City Clinical Oncology Dispensary, St Petersburg, Russia.'}, {'ForeName': 'Volodymyr', 'Initials': 'V', 'LastName': 'Shamrai', 'Affiliation': 'Vinnytsia Regional Clinical Oncological Dispensary, Vinnytsia, Ukraine.'}, {'ForeName': 'Giorgi', 'Initials': 'G', 'LastName': 'Dzagnidze', 'Affiliation': 'S. Khechinashvili University Hospital, Tbilisi, Georgia.'}, {'ForeName': 'Hwoei', 'Initials': 'H', 'LastName': 'Fen', 'Affiliation': 'Penang General Hospital, Penang Island, Malaysia.'}, {'ForeName': 'Viriya', 'Initials': 'V', 'LastName': 'Kaewkangsadan', 'Affiliation': 'Department of Surgery, Phramongkutklao hospital, Bangkok, Thailand.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Petrelli', 'Affiliation': 'Oncology Unit, ASST Bergamo Ovest, Trevigilio, Bergamo, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Villanueva', 'Affiliation': 'Clinique Clementville, Montpellier, Montpellier, France.'}, {'ForeName': 'Lipatov O', 'Initials': 'LO', 'LastName': 'Nikolaevich', 'Affiliation': 'Republican Clinical Oncology Dispensary of Ministry of Health Bashkortostan Republic, Republic of Russia.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Hii', 'Affiliation': 'Prestige BioPharma Ltd, Singapore.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Prestige BioPharma Ltd, Singapore.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Pradhan', 'Affiliation': 'Prestige BioPharma Ltd, Singapore.'}, {'ForeName': 'Litha', 'Initials': 'L', 'LastName': 'Jaison', 'Affiliation': 'Prestige BioPharma Ltd, Singapore.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Feyaerts', 'Affiliation': 'Prestige BioPharma Ltd, Singapore.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Kaufman', 'Affiliation': 'DICE, Naamloze vennootschap, Belgium.'}, {'ForeName': 'Marie-Paule', 'Initials': 'MP', 'LastName': 'Derde', 'Affiliation': 'DICE, Naamloze vennootschap, Belgium.'}, {'ForeName': 'Ghislain M C', 'Initials': 'GMC', 'LastName': 'Bonamy', 'Affiliation': 'Prestige BioPharma Ltd, Singapore.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Deforce', 'Affiliation': 'DICE, Naamloze vennootschap, Belgium.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Cox', 'Affiliation': 'Institute of Cancer Strasbourg, Strasbourg, France.'}]",JAMA oncology,['10.1001/jamaoncol.2021.8171']
3175,35238818,Comparison of pulmonary emboli management between pulmonary emboli response team (PERT) and the conventional method: the first study from Iran.,"BACKGROUND


We aimed to evaluate the effectiveness of the Pulmonary Embolism Response Team (PERT) for intermediate-high risk and high-risk PE patients.
METHODS


This single-blind clinical trial was performed in 2019-2021, evaluating patients with intermediate-high risk and high risk of PE. Patients in the intervention group were managed by the PERT team, and treatment plans were implemented as soon as possible. Patients in the other group received conventional PE treatments based on the hospital protocols. We compared the primary outcome of short-term mortality between the two groups and secondary outcomes, including RV indices, hospital length-of-stay (LOS), time to decision, 30-day and in-hospital bleeding.
RESULTS


Data of 74 patients was analyzed. We found no significant differences between the two groups regarding short-term mortality (P= 0.642), bleeding, and other complications. However, the LOS and time to decision were significantly lower in patients treated by the PERT team (P< 0.001 for both). Further evaluations revealed that patients in the intervention group had a more significant reduction in the right ventricle size and systolic pulmonary pressure (sPAP) compared to the control group (P= 0.015, P= 0.039 respectively). In addition, tricuspid annular plane systolic excursion (TAPSE) and Fractional Area Change (FAC) increased more in the intervention group (P= 0.023, P= 0.016, respectively).
CONCLUSION


the PERT team led to significantly less time to make decisions, and it was able to select patients for advanced treatments more appropriately. Due to these facts, patients treated by PERT had significantly lower hospitalization duration and better RV indices compared to controls.",2022,"Further evaluations revealed that patients in the intervention group had a more significant reduction in the right ventricle size and systolic pulmonary pressure (sPAP) compared to the control group (P= 0.015, P= 0.039 respectively).","['2019-2021, evaluating patients with intermediate-high risk and high risk of PE', '74 patients was analyzed']","['PERT', 'conventional PE', 'Pulmonary Embolism Response Team (PERT']","['tricuspid annular plane systolic excursion (TAPSE) and Fractional Area Change (FAC', 'hospitalization duration and better RV indices', 'LOS and time to decision', 'right ventricle size and systolic pulmonary pressure (sPAP', 'short-term mortality', 'RV indices, hospital length-of-stay (LOS), time to decision, 30-day and in-hospital bleeding', 'bleeding, and other complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C3888926', 'cui_str': 'Tricuspid annular plane systolic excursion'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0225883', 'cui_str': 'Right cardiac ventricular structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0546597,"Further evaluations revealed that patients in the intervention group had a more significant reduction in the right ventricle size and systolic pulmonary pressure (sPAP) compared to the control group (P= 0.015, P= 0.039 respectively).","[{'ForeName': 'Mohammad Hadi', 'Initials': 'MH', 'LastName': 'Mansouri', 'Affiliation': 'Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran. Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Esmaeili', 'Affiliation': ''}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Khosravi', 'Affiliation': ''}, {'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Mansouri', 'Affiliation': ''}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mirmohammadsadeghi', 'Affiliation': ''}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Dehghan', 'Affiliation': ''}, {'ForeName': 'Mana', 'Initials': 'M', 'LastName': 'Jameie', 'Affiliation': ''}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Amirpour', 'Affiliation': ''}, {'ForeName': 'Reihaneh', 'Initials': 'R', 'LastName': 'Zavvar', 'Affiliation': ''}]",Critical pathways in cardiology,['10.1097/HPC.0000000000000279']
3176,35238807,The safety of glucocorticoids in the treatment of inflammatory rheumatic disease: new evidence.,"PURPOSE OF REVIEW


Glucocorticoids justifiably remain a cornerstone in the treatment of many inflammatory rheumatic diseases but many are opposed to their use because of the side effects, most of them known to be dose-dependent. Most concerns regarding glucocorticoids stem from observational studies which are affected by several forms of bias, mainly confounding by indication, that may result in overestimation of harm. Solid evidence regarding the safety of low-dose glucocorticoids remains remarkably scarce.
RECENT FINDINGS


Several observational studies showed heterogeneous results and two 6-month trials showed no increase of harm. The GLORIA trial of 5 mg/day prednisolone vs. placebo in patients aged 65+ is the first randomized control trial with glucocorticoids safety as coprimary outcome. The benefits of glucocorticoids in terms of symptoms and structural damage were confirmed, but the proportion of patients with at least one adverse event of special interest (serious or glucocorticoids-related) was increased by 24%, mostly due to nonsevere infections.
SUMMARY


Based on current evidence the benefit-risk balance of low-dose glucocorticoids in rheumatoid arthritis, and probably in other rheumatic diseases is generally favourable. Physicians should be aware of the risks and mitigate them, but avoid the negative effects of unfounded fear.",2022,"The benefits of glucocorticoids in terms of symptoms and structural damage were confirmed, but the proportion of patients with at least one adverse event of special interest (serious or glucocorticoids-related) was increased by 24%, mostly due to nonsevere infections.
","['inflammatory rheumatic disease', 'patients aged 65']","['glucocorticoids', 'prednisolone vs. placebo']",[],"[{'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.138417,"The benefits of glucocorticoids in terms of symptoms and structural damage were confirmed, but the proportion of patients with at least one adverse event of special interest (serious or glucocorticoids-related) was increased by 24%, mostly due to nonsevere infections.
","[{'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Luís', 'Affiliation': 'Rheumatology Department, Centro Hospitalar e Universitário de Coimbra Faculty of Medicine, University of Coimbra, Coimbra, Portugal Department of Epidemiology & Biostatistics, VU University Medical Center, Amsterdam Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands Division of Clinical Immunology and Rheumatology, Center for Education and Research on Therapeutics University of Alabama at Birmingham, Birmingham, Alabama, USA Department of Rheumatology and Clinical Immunology, Charité University Medicine, Berlin, Germany Coimbra Institute for Clinical and Biomedical Research (iCBR), Faculty of Medicine, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Boers', 'Affiliation': ''}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Saag', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Buttgereit', 'Affiliation': ''}, {'ForeName': 'José A P', 'Initials': 'JAP', 'LastName': 'da Silva', 'Affiliation': ''}]",Current opinion in rheumatology,['10.1097/BOR.0000000000000870']
3177,35238805,"The Knee Injury and Osteoarthritis Outcome Score Does Not Have Adequate Structural Validity for Use with Young, Active Patients with ACL Tears.","BACKGROUND


The Knee Injury and Osteoarthritis Outcome Score (KOOS) is well known and commonly used to assess young, active patients with ACL injuries. However, this application of the outcome measure has been called into question. There is currently no evidence supporting the structural validity of the KOOS for this patient population. Structural validity refers to whether a questionnaire meant to provide scores on different subscales behaves as intended in the populations of interest. Structural validity should be assessed for all questionnaire measures with multiple items or subscales.
QUESTIONS/PURPOSES


Does the KOOS demonstrate adequate structural validity in young, active patients with ACL tears, when evaluated using (1) exploratory and (2) confirmatory factor analyses?
METHODS


Between January 2014 and March 2017, 1033 patients were screened for eligibility in the Stability 1 randomized controlled trial from nine centers in Canada and Europe. Patients were eligible if they had an ACL deficient knee, were between 14 and 25 years old, and were thought to be at higher risk of reinjury based on the presence of two or more of the following factors: participation in pivoting sports, presence of a Grade 2 pivot shift or greater, generalized ligamentous laxity (Beighton score of 4 or greater), or genu recurvatum greater than 10°. Based on this criteria, 367 patients were ineligible and another 48 declined to participate. In total, 618 patients were randomized into the trial. Of the trial participants, 98% (605 of 618) of patients had complete baseline KOOS questionnaire data available for this analysis. Based on study inclusion criteria, the baseline KOOS data from the Stability 1 trial represents an appropriate sample to investigate the structural validity of the KOOS, specifically for the young, active ACL deficient population.A cross sectional retrospective secondary data analysis of the Stability 1 baseline KOOS data was completed to assess the structural validity of the KOOS using exploratory and confirmatory factor analyses. Exploratory factor analysis investigates how all questionnaire items group together based on their conceptual similarity in a specific sample. Confirmatory factor analysis is similar but used often in a second stage to test and confirm a proposed structure of the subscales. These methods were used to assess the established five-factor structure of the KOOS (symptoms [seven items], pain [nine items], activities of daily living [17 items], sport and recreation [five items], and quality of life [four items]) in young active patients with ACL tears. Incremental posthoc modifications, such as correlating questionnaire items or moving items to different subscales, were made to the model structure until adequate fit was achieved. Model fit was assessed using chi-square, root mean square error of approximation (RMSEA) and an associated 90% confidence interval, comparative fit index (CFI), Tucker-Lewis index (TLI), as well as standardized root mean square residual (SRMR). Adequate fit was defined as a CFI and TLI > 0.9, and RMSEA and SRMR < 0.08.
RESULTS


Structural validity of the KOOS was not confirmed when evaluated using (1) exploratory or (2) confirmatory factor analyses. The exploratory factor analysis, where the 42 KOOS items were allowed to group naturally, did not reflect adequate fit for a five-factor model (TLI = 0.828). Similarly, the confirmatory factor analysis used to investigate the KOOS structure as it was originally developed, revealed inadequate fit in our sample (RMSEA = 0.088 [90% CI 0.086 to 0.091]). Our analysis suggested a modified four-factor structure may be more appropriate in young, active ACL deficient patients; however, the final version presented here is not appropriate for clinical use because of the number and nature of post-hoc modifications required to reach adequate fit indices.
CONCLUSION


The established five-factor structure of the KOOS did not hold true in our sample of young, active patients undergoing ACL reconstruction, indicating poor structural validity.
CLINICAL RELEVANCE


We question the utility and interpretability of KOOS subscale scores for young, active patients with ACL tears with the current form of the KOOS. A modified version of the KOOS, adjusted for this patient population, is needed to better reflect and interpret the outcomes and recovery trajectory in this high-functioning group. A separate analysis with a defined a priori development plan would be needed to create a valid alternative.",2022,"RESULTS


Structural validity of the KOOS was not confirmed when evaluated using (1) exploratory or (2) confirmatory factor analyses.","['young, active patients with ACL tears with the current form of the KOOS', 'Patients were eligible if they had an ACL deficient knee, were between 14 and 25 years old, and were thought to be at higher risk of reinjury based on the presence of two or more of the following factors: participation in pivoting sports, presence of a Grade 2 pivot shift or greater, generalized ligamentous laxity (Beighton score of 4 or greater), or genu recurvatum greater than 10°', 'Between January 2014 and March 2017, 1033 patients were screened for eligibility in the Stability 1 randomized controlled trial from nine centers in Canada and Europe', '367 patients were ineligible and another 48 declined to participate', 'young active patients with ACL tears', 'young, active patients with ACL injuries', '618 patients']",[],"['comparative fit index (CFI), Tucker-Lewis index (TLI), as well as standardized root mean square residual (SRMR', 'KOOS subscale scores', 'pain [nine items], activities of daily living [17 items], sport and recreation [five items], and quality of life [four items']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0086437', 'cui_str': 'Joint laxity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0152235', 'cui_str': 'Congenital genu recurvatum'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}]",[],"[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",618.0,0.0516867,"RESULTS


Structural validity of the KOOS was not confirmed when evaluated using (1) exploratory or (2) confirmatory factor analyses.","[{'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Marmura', 'Affiliation': 'Faculty of Health Sciences, Western University, London, ON, Canada.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Tremblay', 'Affiliation': 'Department of Psychology, Western University, London, ON, Canada.'}, {'ForeName': 'Alan M J', 'Initials': 'AMJ', 'LastName': 'Getgood', 'Affiliation': 'Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.'}, {'ForeName': 'Dianne M', 'Initials': 'DM', 'LastName': 'Bryant', 'Affiliation': 'Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000002158']
3178,35238798,"Melatonin reduces muscle damage, inflammation and oxidative stress induced by exhaustive exercise in people with overweight/obesity.","Background


Intense physical exercise leads to inflammation, oxidative stress and muscle damage, and these responses are of greater magnitude in people with obesity. Melatonin (MLT) is considered an endogenous antioxidant which may have beneficial effects against inflammation, oxidative stress and promote tissue repair after exercise. The aim of this study was to examine the effect of MLT on inflammatory parameters, oxidative stress and muscle damage in people with overweight/obesity after a high-intensity interval exercise (HIIE).
Methods


A total of 23 subjects with obesity (9 men and 14 women) age: 33.26 ± 9.81 years, BMI: 37.75 ± 8.87 kg.m-2 were randomized to participate in two experimental sessions: HIIE + Placebo and HIIE + MLT (3 mg). The HIIE protocol corresponds to 8 intervals of 1 min (90% of the maximal aerobic power (MAP)) alternating with 2 min recovery (45% of the MAP). Blood samples were drawn before and 5 min after each exercise session.
Results


MLT ingestion attenuated the increase of inflammation (C-reactive protein, white blood cells (P < 0.001, ηp2 = 0.45; for both) and Neutrophils (P < 0.01, ηp2 = 0.36)) and hepatic and muscle damage (Aspartate aminotransferase (P < 0.01, ηp2 = 0.25), Alanine aminotransferase (P < 0.01, ηp2 = 0.27) and Creatine kinase (P = 0.02, ηp2 = 0.23). MLT also attenuated the exercise induced lipid and protein peroxidation (i.e., Malondialdehyde (P = 0.03, ηp2 = 0.19) and AOPP (P < 0.001, ηp2 = 0.55)). Concerning the antioxidant status, MLT intake increased Thiol (P < 0.01, ηp2 = 0.26) and Catalase (P < 0.01, ηp2 = 0.32) and decreased Uric acid (P = 0.02, ηp2 = 0.2) and Total bilirubin (P < 0.01, ηp2 = 0.33).
Conclusions


MLT intake before HIIE reduced muscle damage by modulating oxidative stress and preventing overexpression of the pro-inflammatory mediators in people with obesity.",2022,"Results


MLT ingestion attenuated the increase of inflammation (C-reactive protein, white blood cells (P < 0.001, ηp2 = 0.45; for both) and Neutrophils (P < 0.01, ηp2 = 0.36)) and hepatic and muscle damage (Aspartate aminotransferase (P < 0.01, ηp2 = 0.25), Alanine aminotransferase (P < 0.01, ηp2 = 0.27) and Creatine kinase (P = 0.02, ηp2 = 0.23).","['23 subjects with obesity (9 men and 14 women) age: 33.26 ± 9.81 years, BMI: 37.75 ± 8.87 kg.m-2', 'people with overweight/obesity', 'people with overweight/obesity after a high-intensity interval exercise (HIIE', 'people with obesity']","['MLT', 'Melatonin', 'Melatonin (MLT', 'HIIE + Placebo and HIIE + MLT']","['AOPP', 'hepatic and muscle damage (Aspartate aminotransferase', 'inflammatory parameters, oxidative stress and muscle damage', 'Alanine aminotransferase', 'muscle damage, inflammation and oxidative stress', 'exercise induced lipid and protein peroxidation', 'inflammation (C-reactive protein, white blood cells', 'Uric acid', 'Creatine kinase', 'Total bilirubin']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}]",23.0,0.06666,"Results


MLT ingestion attenuated the increase of inflammation (C-reactive protein, white blood cells (P < 0.001, ηp2 = 0.45; for both) and Neutrophils (P < 0.01, ηp2 = 0.36)) and hepatic and muscle damage (Aspartate aminotransferase (P < 0.01, ηp2 = 0.25), Alanine aminotransferase (P < 0.01, ηp2 = 0.27) and Creatine kinase (P = 0.02, ηp2 = 0.23).","[{'ForeName': 'Imen', 'Initials': 'I', 'LastName': 'Ben Dhia', 'Affiliation': '1 Research Laboratory: Education, Motricité, Sport et Santé (EM2S) LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Maaloul', 'Affiliation': '1 Research Laboratory: Education, Motricité, Sport et Santé (EM2S) LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Houssem', 'Initials': 'H', 'LastName': 'Marzougui', 'Affiliation': '1 Research Laboratory: Education, Motricité, Sport et Santé (EM2S) LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Sameh', 'Initials': 'S', 'LastName': 'Ghroubi', 'Affiliation': '2 Research Laboratory of Evaluation and Management of Musculoskeletal System Pathologies, LR20ES09, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Choumous', 'Initials': 'C', 'LastName': 'Kallel', 'Affiliation': '4 Hematology Laboratory, CHU Habib Bourguiba, Sfax, Tunisia.'}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': '5 Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical Activity, Health and Learning (LINP2), UFR STAPS, UPL, Paris Nanterre, Nanterre, France.'}, {'ForeName': 'Mohamed Habib', 'Initials': 'MH', 'LastName': 'Elleuch', 'Affiliation': '2 Research Laboratory of Evaluation and Management of Musculoskeletal System Pathologies, LR20ES09, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Ayadi', 'Affiliation': '3 Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Mouna', 'Initials': 'M', 'LastName': 'Turki', 'Affiliation': '3 Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hammouda', 'Affiliation': '3 Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine, University of Sfax, Sfax, Tunisia.'}]",Physiology international,['10.1556/2060.2022.00126']
3179,35239196,Exploring attention to the Canadian 24-Hour Movement Guidelines for Children and Youth using eye-tracking: A randomized control trial.,"BACKGROUND


The Canadian 24-Hour Movement Guidelines for Children and Youth (""Guidelines"") not only pioneered the notion of an integrated movement continuum from sleep to vigorous-intensity physical activity but also introduced a new branded Guideline visual identity.
OBJECTIVES


This study evaluated youths' (N = 46) attention to and thoughts about the Guidelines and the brand.
DESIGN


A cross-sectional between-participants randomized intervention design was used.
SAMPLE


Canadian youth between 10 and 17 years of age comprised the study sample.
INTERVENTIONS


Participants were randomly assigned to view either branded Guidelines (n = 26) or unbranded Guidelines (n = 20). Youths' eye-movements (e.g., dwell time, fixation count) were recorded during Guideline viewing. Participants completed a follow-up survey assessing brand perceptions and Guideline cognitions.
RESULTS


The branded Guidelines neither drew greater overall attention nor led to more positive brand perceptions or Guideline cognitions compared to the unbranded Guidelines.
CONCLUSIONS


Exploratory analyses provide valuable, yet preliminary insight into how branding and Guideline content may shape how Guidelines are perceived and acted upon. These findings inform an agenda for future health education resources.",2022,"The branded Guidelines neither drew greater overall attention nor led to more positive brand perceptions or Guideline cognitions compared to the unbranded Guidelines.
","[""youths' (N = 46) attention to and thoughts about the Guidelines and the brand"", 'SAMPLE\n\n\nCanadian youth between 10 and 17 years of age comprised the study sample', 'Children and Youth (""Guidelines', 'Children and Youth using eye-tracking']","['Canadian 24-Hour Movement Guidelines', 'unbranded Guidelines']","['positive brand perceptions or Guideline cognitions', ""Youths' eye-movements (e.g., dwell time, fixation count""]","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",46.0,0.0645055,"The branded Guidelines neither drew greater overall attention nor led to more positive brand perceptions or Guideline cognitions compared to the unbranded Guidelines.
","[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Walters', 'Affiliation': ""School of Kinesiology & Health Studies, Queen's University, Kingston, ON.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lithopoulos', 'Affiliation': ""School of Kinesiology & Health Studies, Queen's University, Kingston, ON.""}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Tennant', 'Affiliation': ""School of Kinesiology & Health Studies, Queen's University, Kingston, ON.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Weissman', 'Affiliation': ""School of Kinesiology & Health Studies, Queen's University, Kingston, ON.""}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Latimer-Cheung', 'Affiliation': ""School of Kinesiology & Health Studies, Queen's University, Kingston, ON.""}]","Public health nursing (Boston, Mass.)",['10.1111/phn.13064']
3180,35239175,High-volume hemodiafiltration decreases the pre-dialysis concentrations of indoxyl sulfate and p-cresyl sulfate compared to hemodialysis: a post-hoc analysis from the HDFit randomized controlled trial.,"BACKGROUND


Although high-volume online hemodiafiltration has been associated with higher clearance and lower pre-dialysis concentration of middle molecular weight toxins compared to hemodialysis, its effect on protein-bound uremic toxins has shown inconclusive results. In this study, we investigated whether hemodiafiltration impacts pre-dialysis plasma levels of the toxins indoxyl sulfate, p-cresyl sulfate, and indole-3-acetic acid compared to high-flux hemodialysis.
METHODS


This is a post-hoc analysis of the multicenter, randomized controlled trial HDFit (ClinicalTrials.gov: NCT02787161). Uremic toxins were determined by high performance liquid chromatography at baseline, 3, and 6 months. Mean differences in monthly changes of pre-dialysis uremic toxin concentrations between hemodiafiltration and high-flux hemodialysis were analyzed using linear mixed-effect models.
RESULTS


One hundred ninety-three patients (mean age 53 years old, 71% males) were analyzed. There were no differences between groups regarding clinical and biochemical characteristics at baseline or duration of dialysis session and blood flows throughout the follow-up. Mean differences in rates of change (μM/month, [confidence interval CI]) in high-flux hemodialysis vs. hemodiafiltration were 2.4 [0.3 to 4.56], 3.94 [- 1.54 to 9.41] and 0.06 [- 0.6 to 0.5] for indoxyl sulfate, p-cresyl sulfate and indole-3-acetic acid, respectively. In the exploratory analysis, these differences in high-flux hemodialysis vs. hemodiafiltration subgroup with convective volume > 27.5 L were 2.86 [0.43 to 5.28], 7.43 [0.7 to 14.16] and - 0.19 [- 0.88 to 0.50].
CONCLUSION


These exploratory findings suggest that hemodiafiltration is more effective in reducing indoxyl sulfate as compared to standard high-flux hemodialysis, and also that this effect was extended to p-cresyl sulfate in patients achieving higher convective volumes.",2022,There were no differences between groups regarding clinical and biochemical characteristics at baseline or duration of dialysis session and blood flows throughout the follow-up.,"['One hundred ninety-three patients (mean age 53\xa0years old, 71% males']","['toxins indoxyl sulfate, p-cresyl sulfate, and indole-3-acetic acid', 'indoxyl sulfate and p-cresyl sulfate']","['clinical and biochemical characteristics at baseline or duration of dialysis session and blood flows', 'Uremic toxins']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0040549', 'cui_str': 'Toxin'}, {'cui': 'C0021210', 'cui_str': 'Indican'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0936060', 'cui_str': 'Indoleacetic acid'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0040549', 'cui_str': 'Toxin'}]",193.0,0.0753586,There were no differences between groups regarding clinical and biochemical characteristics at baseline or duration of dialysis session and blood flows throughout the follow-up.,"[{'ForeName': 'Jordana D', 'Initials': 'JD', 'LastName': 'Lima', 'Affiliation': 'Department of Basic Pathology, Universidade Federal do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Murilo', 'Initials': 'M', 'LastName': 'Guedes', 'Affiliation': 'School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Silvia D', 'Initials': 'SD', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Basic Pathology, Universidade Federal do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Ana Clara S', 'Initials': 'ACS', 'LastName': 'Flórido', 'Affiliation': 'School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Moreno-Amaral', 'Affiliation': 'School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Ana Beatriz', 'Initials': 'AB', 'LastName': 'Barra', 'Affiliation': 'Fresenius Medical Care, Rio de Janeiro, Brazil.'}, {'ForeName': 'Maria Eugênia', 'Initials': 'ME', 'LastName': 'Canziani', 'Affiliation': 'Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Américo', 'Initials': 'A', 'LastName': 'Cuvello-Neto', 'Affiliation': 'Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Poli-de-Figueiredo', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pecoits-Filho', 'Affiliation': 'School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Lia S', 'Initials': 'LS', 'LastName': 'Nakao', 'Affiliation': 'Department of Basic Pathology, Universidade Federal do Paraná, Curitiba, Brazil. lia.nakao@ufpr.br.'}]",Journal of nephrology,['10.1007/s40620-022-01283-3']
3181,35239136,"Editorial Expression of Concern for: Taghizadeh, M., Asemi, Z. Effects of synbiotic food consumption on glycemic status and serum hs-CRP in pregnant women: a randomized controlled clinical trial.",,2022,,['pregnant women'],['synbiotic food consumption'],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",[],,0.19813,,"[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Taghizadeh', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, IR, Iran.'}, {'ForeName': 'Zatolla', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, IR, Iran. asemi_r@yahoo.com.'}]","Hormones (Athens, Greece)",['10.1007/s42000-022-00349-y']
3182,35239109,"Clinic, Home, and Kiosk Blood Pressure Measurements for Diagnosing Hypertension: a Randomized Diagnostic Study.","BACKGROUND


The US Preventive Services Task Force recommends blood pressure (BP) measurements using 24-h ambulatory monitoring (ABPM) or home BP monitoring before making a new hypertension diagnosis.
OBJECTIVE


Compare clinic-, home-, and kiosk-based BP measurement to ABPM for diagnosing hypertension.
DESIGN, SETTING, AND PARTICIPANTS


Diagnostic study in 12 Washington State primary care centers, with participants aged 18-85 years without diagnosed hypertension or prescribed antihypertensive medications, with elevated BP in clinic.
INTERVENTIONS


Randomization into one of three diagnostic regimens: (1) clinic (usual care follow-up BPs); (2) home (duplicate BPs twice daily for 5 days); or (3) kiosk (triplicate BPs on 3 days). All participants completed ABPM at 3 weeks.
MAIN MEASURES


Primary outcome was difference between ABPM daytime and clinic, home, and kiosk mean systolic BP. Differences in diastolic BP, sensitivity, and specificity were secondary outcomes.
KEY RESULTS


Five hundred ten participants (mean age 58.7 years, 80.2% white) with 434 (85.1%) included in primary analyses. Compared to daytime ABPM, adjusted mean differences in systolic BP were clinic (-4.7mmHg [95% confidence interval -7.3, -2.2]; P<.001); home (-0.1mmHg [-1.6, 1.5];P=.92); and kiosk (9.5mmHg [7.5, 11.6];P<.001). Differences for diastolic BP were clinic (-7.2mmHg [-8.8, -5.5]; P<.001); home (-0.4mmHg [-1.4, 0.7];P=.52); and kiosk (5.0mmHg [3.8, 6.2]; P<.001). Sensitivities for clinic, home, and kiosk compared to ABPM were 31.1% (95% confidence interval, 22.9, 40.6), 82.2% (73.8, 88.4), and 96.0% (90.0, 98.5), and specificities 79.5% (64.0, 89.4), 53.3% (38.9, 67.2), and 28.2% (16.4, 44.1), respectively.
LIMITATIONS


Single health care organization and limited race/ethnicity representation.
CONCLUSIONS


Compared to ABPM, mean BP was significantly lower for clinic, significantly higher for kiosk, and without significant differences for home. Clinic BP measurements had low sensitivity for detecting hypertension. Findings support utility of home BP monitoring for making a new diagnosis of hypertension.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03130257 https://clinicaltrials.gov/ct2/show/NCT03130257.",2022,"Compared to ABPM, mean BP was significantly lower for clinic, significantly higher for kiosk, and without significant differences for home.","['mean age 58.7 years, 80.2% white) with 434 (85.1%) included in primary analyses', 'Diagnostic study in 12 Washington State primary care centers, with participants aged 18-85 years without diagnosed hypertension or prescribed antihypertensive medications, with elevated BP in clinic', 'Five hundred ten participants ']","['24-h ambulatory monitoring (ABPM) or home BP monitoring', 'clinic-, home-, and kiosk-based BP measurement to ABPM', 'Randomization into one of three diagnostic regimens: (1) clinic (usual care follow-up BPs); (2) home (duplicate BPs twice daily for 5 days); or (3) kiosk (triplicate BPs']","['ABPM daytime and clinic, home, and kiosk mean systolic BP', 'diastolic BP, sensitivity, and specificity', 'ABPM, mean BP', 'blood pressure (BP) measurements', 'diastolic BP', 'Sensitivities for clinic, home, and kiosk compared to ABPM', 'systolic BP']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0242882', 'cui_str': 'Ambulatory Monitoring'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1849718', 'cui_str': 'Autosomal recessive popliteal pterygium syndrome'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205174', 'cui_str': 'Triple'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",510.0,0.314425,"Compared to ABPM, mean BP was significantly lower for clinic, significantly higher for kiosk, and without significant differences for home.","[{'ForeName': 'Beverly B', 'Initials': 'BB', 'LastName': 'Green', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA. Bev.B.Green@kp.org.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Anderson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Cook', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Ehrlich', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Yoshio N', 'Initials': 'YN', 'LastName': 'Hall', 'Affiliation': 'Kidney Research Institute, University of Washington Department of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Hsu', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Dwayne', 'Initials': 'D', 'LastName': 'Joseph', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Klasnja', 'Affiliation': 'University of Michigan, School of Information, Ann Arbor, MI, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Margolis', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, USA.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'McClure', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Munson', 'Affiliation': 'Department of Human Centered Design and Engineering, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Thompson', 'Affiliation': 'Department of Family Medicine, University of Washington, Seattle, WA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-022-07400-z']
3183,35239083,Acceptance and Commitment Therapy Group Intervention for Parents of Children with Disabilities (Navigator ACT): An Open Feasibility Trial.,"Parents of children with autism spectrum disorder and other disabilities report high levels of distress, but systematically evaluated interventions are few. This study aimed to evaluate the feasibility of a novel, manualized Acceptance and Commitment Therapy group intervention (Navigator ACT) in a sample of 94 parents of children with disabilities. Feasibility was measured by treatment completion, credibility, and satisfaction, and preliminary outcomes by using self-rating scales administered at the baseline, post-intervention, and follow-up. The results imply the intervention is feasible in the context of Swedish outpatient habilitation services. A preliminary analysis of the outcome measures suggests that parents experienced significant improvements in well-being. The results indicate that the treatment is feasible and should be evaluated in a randomized controlled trial.",2022,"This study aimed to evaluate the feasibility of a novel, manualized Acceptance and Commitment Therapy group intervention (Navigator ACT) in a sample of 94 parents of children with disabilities.","['94 parents of children with disabilities', 'Parents of children with autism spectrum disorder and other disabilities report high levels of distress', 'Parents of Children with Disabilities (Navigator ACT']","['novel, manualized Acceptance and Commitment Therapy group intervention (Navigator ACT']","['credibility, and satisfaction, and preliminary outcomes by using self-rating scales']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0259916', 'cui_str': 'Child, Disabled'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",94.0,0.0194789,"This study aimed to evaluate the feasibility of a novel, manualized Acceptance and Commitment Therapy group intervention (Navigator ACT) in a sample of 94 parents of children with disabilities.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Holmberg Bergman', 'Affiliation': ""Department of Women's and Children's Health, Pediatric Neuropsychiatry Unit, Center for Neurodevelopmental Disorders at Karolinska Institutet (KIND), Gävlegatan 22B, 11330, Stockholm, Sweden. tiina.holmberg.bergman@ki.se.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Renhorn', 'Affiliation': ""Department of Women's and Children's Health, Pediatric Neuropsychiatry Unit, Center for Neurodevelopmental Disorders at Karolinska Institutet (KIND), Gävlegatan 22B, 11330, Stockholm, Sweden.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Berg', 'Affiliation': 'Habilitation and Health, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lappalainen', 'Affiliation': 'Department of Psychology, University of Jyväskylä, PO Box 35, 40014, Jyväskylä, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Nobels väg 9, 17165, Stockholm, Sweden.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hirvikoski', 'Affiliation': ""Department of Women's and Children's Health, Pediatric Neuropsychiatry Unit, Center for Neurodevelopmental Disorders at Karolinska Institutet (KIND), Gävlegatan 22B, 11330, Stockholm, Sweden.""}]",Journal of autism and developmental disorders,['10.1007/s10803-022-05490-6']
3184,35241174,The efficacy of eye movement desensitization and reprocessing in reducing anxiety among female university students with primary dysmenorrhea.,"BACKGROUND


Unpleasant experiences of dysmenorrhea can lead to increased anxiety. The anxiety associated with dysmenorrhea is a pain-related anxiety which might reduce the efficacy of medication as well as enhance the perception of pain. The present study evaluated the efficacy of eye movement desensitization and reprocessing (EMDR) in reducing anxiety among female university students with primary dysmenorrhea.
METHODS


In this randomized controlled trial, 88 female university students were recruited from April 2019 to February 2020. Eligible participants were selected by convenience sampling and were allocated into study groups (44 individuals in the intervention group and comparison group) using balanced block randomization. The final sample comprised 78 participants who completed the study (39 individuals in each group). Data were collected using the Spielberger State-Trait Anxiety Inventory, Subjective Units of Distress Scale, and Validity of Cognition Scale before the intervention and at the time of the first menstrual period after completion of the intervention. The intervention group received EMDR in two individual interventional sessions which lasted approximately one hour. Data analysis was performed using analysis of variance with control of covariance method at a significance level of 0.05.
RESULTS


The results of the study showed that EMDR did not have a statistically significant effect on State-Trait Anxiety of patients with dysmenorrhea (p > 0.05). Based on the Cohen's d effect size of 0.06 for state-anxiety, -0.01 for trait-anxiety, and partial eta square less than 0.059 for both uncorrected and corrected models, the intervention was within a trivial effect.
CONCLUSION


EMDR intervention did not have a statistically and clinically significant effect on State-Trait Anxiety of patients with dysmenorrhea. Therefore, the efficacy of EMDR in treating dysmenorrhea-related anxiety remains inconclusive. Trial registration IRCT20180823040851N2 on 2019-02-09.",2022,The results of the study showed that EMDR did not have a statistically significant effect on State-Trait Anxiety of patients with dysmenorrhea (p > 0.05).,"['Eligible participants were selected by convenience sampling and were allocated into study groups (44 individuals in the', 'female university students with primary dysmenorrhea', '78 participants who completed the study (39 individuals in each group', 'patients with dysmenorrhea', '2019-02-09', '88 female university students were recruited from April 2019 to February 2020']","['EMDR', 'eye movement desensitization and reprocessing (EMDR', 'eye movement desensitization and reprocessing', 'EMDR intervention', 'intervention group and comparison group) using balanced block randomization']","['State-Trait Anxiety', 'Spielberger State-Trait Anxiety Inventory, Subjective Units of Distress Scale, and Validity of Cognition Scale']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",78.0,0.0219853,The results of the study showed that EMDR did not have a statistically significant effect on State-Trait Anxiety of patients with dysmenorrhea (p > 0.05).,"[{'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Valedi', 'Affiliation': 'Students Research Committee, School of Nursing and Midwifery, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'MoradiBaglooei', 'Affiliation': 'School of Nursing and Midwifery, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Ranjbaran', 'Affiliation': 'School of Health, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Venus', 'Initials': 'V', 'LastName': 'Chegini', 'Affiliation': 'Obstetrics and Gynecology Department, School of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Griffiths', 'Affiliation': 'International Gaming Research Unit, Psychology Department, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Alimoradi', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Bahonar blv., 34197-59811, Qazvin, Iran. z.alimoradi@qums.ac.ir.'}]",BMC psychology,['10.1186/s40359-022-00757-0']
3185,35241145,The effects of remifentanil-propofol combined with dexmedetomidine on cognitive dysfunction in elderly patients after ureteroscopic holmium laser lithotripsy: a double-blind randomized controlled trial.,"BACKGROUND


A clinical study indicated that infusion of dexmedetomidine without a loading dose administered intraoperatively provided a smooth and hemodynamically stable emergence and improved the quality of recovery with fewer postoperative side effects and reduced analgesic requirements. The objective was to determine whether administering remifentanil-propofol combined with dexmedetomidine during general anesthesia would decrease the incidence and severity of postoperative emergence agitation, anxiety, and depression without affecting cognitive dysfunction in elderly patients.
METHODS


A total of 120 elderly patients scheduled for ureteroscopic holmium laser lithotripsy were randomly allocated to the PR group and administered normal saline, and the PRD group was administered dexmedetomidine 0.4 μg kg -1  h -1  intravenously after the induction of anesthesia and stopped 30 min before the end of surgery. The primary outcome was the Mini-Mental State Examination score. The secondary outcomes were the Richmond Agitation Sedation, the State-Trait Anxiety Inventory, and the Zung Self-Rating Depression Scale scores; the memory span for Arabic numerals; the duration of surgery; and the time to spontaneous respiration, recovery, and extubation.
RESULTS


The MMSE scores were lower at T 1-2  in the two groups (P < 0.001). The dosage of propofol and remifentanil decreased more significantly in the PRD group than in the PR group (P < 0.001). Both the RASS scores and the incidence of emergence agitation (EA) in the PRD group were significantly lower than those in the PR group at t 1-3  (P < 0.001). Compared to the PR group, the ZSDS scores and STAI scores at T 1-2  were lower in the PRD group (P < 0.005). The number of the Arabic numbers that were accurately recalled from memory was lower at T 2  in the PR group than in the PRD group (P < 0.001).
CONCLUSION


Dexmedetomidine administration has no influence on postoperative cognitive dysfunction but could reduce both the dosage of remifentanil and propofol needed during ureteroscopic holmium laser lithotripsy and the incidence and severity of postoperative emergence agitation, anxiety, and depression in elderly patients.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1900021254 . Registered on 3 February 2019.",2022,"A total of 120 elderly patients scheduled for ureteroscopic holmium laser lithotripsy were randomly allocated to the PR group and administered normal saline, and the PRD group was administered dexmedetomidine 0.4 μg kg -1  h -1  intravenously after the induction of anesthesia and stopped 30 min before the end of surgery.","['elderly patients', '120 elderly patients scheduled for', 'elderly patients after']","['propofol and remifentanil', 'dexmedetomidine', 'remifentanil-propofol', 'ureteroscopic holmium laser lithotripsy', 'PR group and administered normal saline', 'Dexmedetomidine']","['Richmond Agitation Sedation, the State-Trait Anxiety Inventory, and the Zung Self-Rating Depression Scale scores; the memory span for Arabic numerals; the duration of surgery; and the time to spontaneous respiration, recovery, and extubation', 'number of the Arabic numbers', 'MMSE scores', 'incidence and severity of postoperative emergence agitation, anxiety, and depression without affecting cognitive dysfunction', 'postoperative cognitive dysfunction', 'Mini-Mental State Examination score', 'RASS scores and the incidence of emergence agitation (EA', 'cognitive dysfunction', 'ZSDS scores and STAI scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C4273947', 'cui_str': 'Zung self rating depression scale score'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439071', 'cui_str': 'Arabic numeral'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}]",120.0,0.135109,"A total of 120 elderly patients scheduled for ureteroscopic holmium laser lithotripsy were randomly allocated to the PR group and administered normal saline, and the PRD group was administered dexmedetomidine 0.4 μg kg -1  h -1  intravenously after the induction of anesthesia and stopped 30 min before the end of surgery.","[{'ForeName': 'Fangjun', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital, North Sichuan Medical College, Nanchong, 637000, China. wfjlxy006@nsmc.edu.cn.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital, North Sichuan Medical College, Nanchong, 637000, China.'}, {'ForeName': 'Hongchun', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital, North Sichuan Medical College, Nanchong, 637000, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital, North Sichuan Medical College, Nanchong, 637000, China.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital, North Sichuan Medical College, Nanchong, 637000, China.'}, {'ForeName': 'Xiao Pei', 'Initials': 'XP', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital, North Sichuan Medical College, Nanchong, 637000, China.'}]",Trials,['10.1186/s13063-022-06121-2']
3186,35241140,Does m-health-based exercise (guidance plus education) improve efficacy in patients with chronic low-back pain? A preliminary report on the intervention's significance.,"BACKGROUND


The utilization of mobile health (m-health) has rapidly expanded during the COVID-19 pandemic, and there is still a lack of relevant clinical data pertaining to chronic low-back pain (CLBP) management. This study was designed to compare the effectiveness of m-health-based exercise (via guidance plus education) versus exercise (via guidance) during CLBP management.
METHODS


Participants (n = 40) were randomly assigned to intervention and control groups. The intervention group received m-health-based exercise (via guidance plus education), whereas the control group received m-health-based exercise (via guidance). The exercise prescription video and educational content were sent to participants by the application (app), Ding Talk. Repeated-measures analysis of variance was used to test the baseline's intervention effects, 6-week follow-up, and 18-week follow-up. We selected function (Roland and Morris Disability Questionnaire) and pain intensity (current, mean, and most severe Numeric Rating Scale in the last 2 weeks) as the primary outcomes, changes of negative emotion (depression, anxious), and quality of life as the secondary outcomes.
RESULTS


Time's significant effect was found in pain, function, and health-related quality of life in both groups, but time did not show significant interaction effects. Participants were able to use m-based education with their anxiety and depression after treatment, but the relief only lasted until week 6. No differences were found on the aspect of mental health-related quality of life.
CONCLUSION


Preliminary findings suggest that m-health-based exercise (via guidance) may be a convenient and effective method to treat CLBP. However, additional health education didn't help more. More rigorous controlled trials are needed to improve the therapeutic effect in future studies.
TRIAL REGISTRATION


Chinese Clinical Trials Registry Number ChiCTR2000041459 . Registered on December 26, 2020.",2022,"RESULTS


Time's significant effect was found in pain, function, and health-related quality of life in both groups, but time did not show significant interaction effects.","['patients with chronic low-back pain', 'Participants (n = 40']","['m-health-based exercise (via guidance plus education) versus exercise (via guidance', 'm-health-based exercise (guidance plus education', 'm-health-based exercise (via guidance plus education), whereas the control group received m-health-based exercise (via guidance']","['aspect of mental health-related quality of life', 'pain, function, and health-related quality of life', 'function (Roland and Morris Disability Questionnaire) and pain intensity (current, mean, and most severe Numeric Rating Scale', 'negative emotion (depression, anxious), and quality of life as the secondary outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",40.0,0.0318078,"RESULTS


Time's significant effect was found in pain, function, and health-related quality of life in both groups, but time did not show significant interaction effects.","[{'ForeName': 'Fuming', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Shufeng', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Qiuhua', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Wai Leung Ambrose', 'Initials': 'WLA', 'LastName': 'Lo', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Tingni', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.'}, {'ForeName': 'Chu Huai', 'Initials': 'CH', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China. wangchuh@mail.sysu.edu.cn.'}]",Trials,['10.1186/s13063-022-06116-z']
3187,35241135,Randomized controlled trial: neostigmine for intra-abdominal hypertension in acute pancreatitis.,"BACKGROUND


Intra-abdominal hypertension (IAH) in acute pancreatitis (AP) is associated with deterioration in organ function. This trial aimed to assess the efficacy of neostigmine for IAH in patients with AP.
METHODS


In this single-center, randomized trial, consenting patients with IAH within 2 weeks of AP onset received conventional treatment for 24 h. Patients with sustained intra-abdominal pressure (IAP) ≥ 12 mmHg were randomized to receive intramuscular neostigmine (1 mg every 12 h increased to every 8 h or every 6 h, depending on response) or continue conventional treatment for 7 days. The primary outcome was the percent change of IAP at 24 h after randomization.
RESULTS


A total of 80 patients were recruited to neostigmine (n = 40) or conventional treatment (n = 40). There was no significant difference in baseline parameters. The rate of decrease in IAP was significantly faster in the neostigmine group compared to the conventional group by 24 h (median with 25th-75th percentile: -18.7% [- 28.4 to - 4.7%] vs. - 5.4% [- 18.0% to 0], P = 0.017). This effect was more pronounced in patients with baseline IAP ≥ 15 mmHg (P = 0.018). Per-protocol analysis confirmed these results (P = 0.03). Stool volume was consistently higher in the neostigmine group during the 7-day observational period (all P < 0.05). Other secondary outcomes were not significantly different between neostigmine and conventional treatment groups.
CONCLUSION


Neostigmine reduced IAP and promoted defecation in patients with AP and IAH. These results warrant a larger, placebo-controlled, double-blind phase III trial. Trial registration Clinical Trial No: NCT02543658 (registered August /27, 2015).",2022,"The rate of decrease in IAP was significantly faster in the neostigmine group compared to the conventional group by 24 h (median with 25th-75th percentile: -18.7% [- 28.4 to - 4.7%] vs. - 5.4% [- 18.0% to 0], P = 0.017).","['consenting patients with IAH within 2\xa0weeks of AP onset received conventional treatment for 24\xa0h. Patients with sustained intra-abdominal pressure (IAP)\u2009≥\u200912\xa0mmHg', 'patients with AP and IAH', 'n\u2009=\u200940) or conventional treatment (n\u2009=\u200940', 'patients with AP', 'acute pancreatitis (AP', 'acute pancreatitis', 'patients with baseline IAP\u2009≥', '80 patients were recruited to']","['neostigmine', 'Neostigmine', 'intramuscular neostigmine']","['Stool volume', 'percent change of IAP', 'IAP and promoted defecation', 'rate of decrease in IAP']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2242710', 'cui_str': 'Intraabdominal Hypertension'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",80.0,0.303554,"The rate of decrease in IAP was significantly faster in the neostigmine group compared to the conventional group by 24 h (median with 25th-75th percentile: -18.7% [- 28.4 to - 4.7%] vs. - 5.4% [- 18.0% to 0], P = 0.017).","[{'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Pancreatic Intensive Care Unit, Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Pancreatic Intensive Care Unit, Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Yupeng', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'Pancreatic Intensive Care Unit, Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Pancreatic Intensive Care Unit, Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Pi', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Pancreatic Intensive Care Unit, Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Pancreatic Intensive Care Unit, Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Pancreatic Intensive Care Unit, Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Pancreatic Intensive Care Unit, Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Huajing', 'Initials': 'H', 'LastName': 'Ke', 'Affiliation': 'Pancreatic Intensive Care Unit, Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Pancreatic Intensive Care Unit, Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Wenhao', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Liverpool Pancreatitis Research Group, Institute of Systems, Molecular and Integrative Biology, University of Liverpool and Liverpool University Hospitals NHS Foundation Trust, Liverpool, Merseyside, UK.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Chinese Evidence-Based Medicine Center and CREAT Group, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Departments of Integrated Traditional Chinese and Western Medicine & Clinical Research Management, Sichuan Provincial Pancreatitis Center & West China-Liverpool Biomedical Research Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sutton', 'Affiliation': 'Liverpool Pancreatitis Research Group, Institute of Systems, Molecular and Integrative Biology, University of Liverpool and Liverpool University Hospitals NHS Foundation Trust, Liverpool, Merseyside, UK.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Pancreatic Intensive Care Unit, Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China. zhuyin27@sina.com.'}, {'ForeName': 'Nonghua', 'Initials': 'N', 'LastName': 'Lu', 'Affiliation': 'Pancreatic Intensive Care Unit, Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China. lunonghua@ncu.edu.cn.'}]","Critical care (London, England)",['10.1186/s13054-022-03922-4']
3188,35241003,"Evaluating the impact of adjunctive istradefylline on the cumulative dose of levodopa-containing medications in Parkinson's disease: study protocol for the ISTRA ADJUST PD randomized, controlled study.","BACKGROUND


Levodopa remains the most effective symptomatic treatment for Parkinson's disease (PD) more than 50 years after its clinical introduction. However, the onset of motor complications can limit pharmacological intervention with levodopa, which can be a challenge when treating PD patients. Clinical data suggest using the lowest possible levodopa dose to balance the risk/benefit. Istradefylline, an adenosine A 2A  receptor antagonist indicated as an adjunctive treatment to levodopa-containing preparations in PD patients experiencing wearing off, is currently available in Japan and the US. Preclinical and preliminary clinical data suggested that adjunctive istradefylline may provide sustained antiparkinsonian benefits without a levodopa dose increase; however, available data on the impact of istradefylline on levodopa dose titration are limited. The ISTRA ADJUST PD study will evaluate the effect of adjunctive istradefylline on levodopa dosage titration in PD patients.
METHODS


This 37-week, multicenter, randomized, open-label, parallel-group controlled study in PD patients aged 30-84 years who are experiencing the wearing-off phenomenon despite receiving levodopa-containing medications ≥ 3 times daily (daily dose 300-400 mg) began in February 2019 and will continue until February 2022. Enrollment is planned to attain 100 evaluable patients for the efficacy analyses. Patients will receive adjunctive istradefylline (20 mg/day, increasing to 40 mg/day) or the control in a 1:1 ratio, stratified by age, levodopa equivalent dose, and presence/absence of dyskinesia. During the study, the levodopa dose will be increased according to symptom severity. The primary study endpoint is the comparison of the cumulative additional dose of levodopa-containing medications during the treatment period between the adjunctive istradefylline and control groups. Secondary endpoints include changes in efficacy rating scales and safety outcomes.
DISCUSSION


This study aims to clarify whether adjunctive istradefylline can reduce the cumulative additional dose of levodopa-containing medications in PD patients experiencing the wearing-off phenomenon, and lower the risk of levodopa-associated complications. It is anticipated that data from ISTRA ADJUST PD will help inform future clinical decision-making for patients with PD in the real-world setting.
TRIAL REGISTRATION


Japan Registry of Clinical Trials, jRCTs031180248 ; registered 12 March 2019.",2022,"This study aims to clarify whether adjunctive istradefylline can reduce the cumulative additional dose of levodopa-containing medications in PD patients experiencing the wearing-off phenomenon, and lower the risk of levodopa-associated complications.","['100 evaluable patients for the efficacy analyses', 'PD patients', ""Parkinson's disease"", 'PD patients aged 30-84\xa0years who are experiencing the wearing-off phenomenon despite receiving levodopa-containing medications\u2009≥\u20093 times daily (daily dose 300-400\xa0mg) began in February 2019 and will continue until February 2022', 'PD patients experiencing the wearing-off phenomenon, and lower the risk of levodopa-associated complications', 'patients with PD in the real-world setting']","['adjunctive istradefylline', 'levodopa', 'levodopa-containing medications']","['efficacy rating scales and safety outcomes', 'comparison of the cumulative additional dose of levodopa-containing medications']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0852903', 'cui_str': 'On - off phenomenon'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0673470', 'cui_str': 'istradefylline'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.139811,"This study aims to clarify whether adjunctive istradefylline can reduce the cumulative additional dose of levodopa-containing medications in PD patients experiencing the wearing-off phenomenon, and lower the risk of levodopa-associated complications.","[{'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Hatano', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Juntendo University, 2-1-1 Hongo, Bunkyo-ku, 113-8421, Tokyo, Japan. thatano@juntendo.ac.jp.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Kano', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Toho University, 6-11-1 Omorinishi, Ota-ku, Tokyo, 143-8541, Japan.'}, {'ForeName': 'Renpei', 'Initials': 'R', 'LastName': 'Sengoku', 'Affiliation': 'Department of Neurology, Jikei University Daisan Hospital, 4-11-1 Izumihoncho, Komae, Tokyo, 201-0003, Japan.'}, {'ForeName': 'Asako', 'Initials': 'A', 'LastName': 'Yoritaka', 'Affiliation': 'Department of Neurology, Juntendo University Koshigaya Hospital, 560 Fukuroyama, Koshigaya-shi, Saitama, 343-0032, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Department of Neurology, Dokkyo Medical University Hospital, 880 Oaza Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Juntendo University, 2-1-1 Hongo, Bunkyo-ku, 113-8421, Tokyo, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Mukai', 'Affiliation': 'Department of Neurology, National Center of Neurology and Psychiatry, 4-1-1 Ogawahigashi-cho, Kodaira-shi, Tokyo, 187-8551, Japan.'}, {'ForeName': 'Kyoichi', 'Initials': 'K', 'LastName': 'Nomura', 'Affiliation': 'Department of Neurology, Saitama Medical Center, Kawagoe-shi, Saitama, 350-8550, Japan.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Yoshida', 'Affiliation': 'Department of Neurology, Saitama Medical Center, Kawagoe-shi, Saitama, 350-8550, Japan.'}, {'ForeName': 'Morinobu', 'Initials': 'M', 'LastName': 'Seki', 'Affiliation': 'Department of Neurology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Miho Kawabe', 'Initials': 'MK', 'LastName': 'Matsukawa', 'Affiliation': 'Department of Neurology, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan.'}, {'ForeName': 'Hiroo', 'Initials': 'H', 'LastName': 'Terashi', 'Affiliation': 'Department of Neurology, Tokyo Medical University Hospital, 6-7-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan.'}, {'ForeName': 'Katsuo', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Department of Neurology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama-shi, Kanagawa, 232-0024, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tashiro', 'Affiliation': 'Sapporo Parkinson MS Neurological Clinic, Dai 27 Big Sapporo-kita Sky Building 12F, 7-6 Kita-7 jo Nishi-5 chome, Kita-ku, Sapporo-shi, Hokkaido, 060-0807, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Hirano', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, Japan.'}, {'ForeName': 'Hidetomo', 'Initials': 'H', 'LastName': 'Murakami', 'Affiliation': 'Department of Neurology, The Jikei University Hospital, 3-19-18 Nishishinbashi, Minato-ku, Tokyo, 105-8471, Japan.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Joki', 'Affiliation': 'Department of Neurology and Stroke Medicine, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Neurology, Seirei Hamamatsu General Hospital, 2-12-12 Sumiyoshi, Naka-ku, Hamamatsu-shi, Shizuoka, 430-8558, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Shimura', 'Affiliation': 'Department of Neurology, Juntendo Tokyo Koto Geriatric Medical Center, 3-3-20 Shinsuna, Koto-ku, Tokyo, 136-0075, Japan.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Ogaki', 'Affiliation': 'Department of Neurology, Juntendo University Urayasu Hospital, 2-1-1 Tomioka, Urayasu-shi, Chiba, 279-0021, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Fukae', 'Affiliation': 'Department of Neurology, Juntendo University Nerima Hospital, 3-1-10 Takano-dai, Nerima-ku, Tokyo, 177-8521, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Neurology, Tokyo Metropolitan Neurological Hospital, Musashidai 2-6-1, Fuchu-shi, Tokyo, 183-0042, Japan.'}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Neurology, Saitama Medical University Hospital, Saitama Medical University, 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan.'}, {'ForeName': 'Naotake', 'Initials': 'N', 'LastName': 'Yanagisawa', 'Affiliation': 'Medical Technology Innovation Center, Juntendo University and Juntendo Clinical Research and Trial Center, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nagayama', 'Affiliation': 'Department of Neurology, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan.'}]",BMC neurology,['10.1186/s12883-022-02600-w']
3189,35238397,Impact of the Comprehensive Care for Joint Replacement Model on Patient Reported Outcomes.,"OBJECTIVE


To determine whether the Comprehensive Care for Joint Replacement (CJR) model, a mandatory episode-based payment program for knee and hip replacement surgery, affected patient-reported measures of quality.
DATA SOURCES


Surveys of Medicare fee-for-service beneficiaries who had hip or knee replacement surgery, collected between July 2018 and March 2019, secondary Medicare administrative data, the Provider of Services file, CJR and Bundled Payments for Care Improvement participant lists from the Centers for Medicare & Medicaid Services, and the Area Health Resource Files.
STUDY DESIGN


In 2018, participation in the CJR model was mandatory for nearly all hospitals in 34 randomly-selected, metropolitan statistical areas (MSAs) that had high historical Medicare payments for lower-extremity joint replacements surgery. The control group included 47 high-payment MSAs randomly assigned as controls. We estimated risk-adjusted differences in self-reported measures of functional status and pain, satisfaction with care, and caregiver help between respondents in CJR hospitals and respondents in hospitals located in the control group.
DATA COLLECTION


We selected a census of CJR patients and an equal number of control patients to survey. We fielded two waves of surveys using a mail and phone protocol, yielding 8433 CJR and 9014 control respondents.
PRINCIPAL FINDINGS


CJR respondents were slightly more likely to depend on caregivers for certain activities of daily living when they got home (either directly from the hospital or after an institutional post-acute care stay). On a 100-point scale, differences ranged from -2.6 points (p <0.01) for help needed bathing to -1.7 points (p <0.05) for help needed using the toilet. However, differences in eight measures of self-reported functional status approximately 90-120 days after hospital discharge were not statistically significant, ranging from -1.1% (p = 0.087) to 0.7% (p = 0.437).
CONCLUSIONS


CJR did not harm patient health or affect patient satisfaction on average but did increase reliance on caregivers during recovery.",2022,"On a 100-point scale, differences ranged from -2.6 points (p <0.01) for help needed bathing to -1.7 points (p <0.05) for help needed using the toilet.","['Surveys of Medicare fee-for-service beneficiaries who had hip or knee replacement surgery, collected between July 2018 and March 2019, secondary Medicare administrative data, the Provider of Services file, CJR and Bundled Payments for Care Improvement participant lists from the Centers for Medicare & Medicaid Services, and the Area Health Resource Files', '34 randomly-selected, metropolitan statistical areas (MSAs) that had high historical Medicare payments for lower-extremity joint replacements surgery']",[],"['functional status and pain, satisfaction with care, and caregiver help']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0242816', 'cui_str': 'Fees for Service'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0185317', 'cui_str': 'Implantation of joint prosthesis'}, {'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0584731', 'cui_str': 'Joint structure of lower extremity'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}]",,0.0797153,"On a 100-point scale, differences ranged from -2.6 points (p <0.01) for help needed bathing to -1.7 points (p <0.05) for help needed using the toilet.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Trombley', 'Affiliation': 'Health Economics Senior Associate, Abt Associates, Division of Health and Environment, 5001 South Miami Blvd., Suite 210, Durham, North Carolina, United States.'}, {'ForeName': 'Rayan', 'Initials': 'R', 'LastName': 'Joneydi', 'Affiliation': 'Health Economics Associate, Abt Associates, Division of Health and Environment, 5001 South Miami Blvd., Suite 210, Durham, North Carolina, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McNeely', 'Affiliation': 'Social Science Research Analyst, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland, United States.'}, {'ForeName': 'Louisa A', 'Initials': 'LA', 'LastName': 'Buatti', 'Affiliation': 'Health Research Monitoring Evaluation Associate, Abt Associates, Division of Health and Environment. 6130 Executive Blvd., Rockville, Maryland, United States.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Schneider', 'Affiliation': 'Managing Consultant, The Lewin Group, 3160 Fairview Park Dr, Falls Church, Virginia, United States.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Kummet', 'Affiliation': 'Program Director Health Analytics, General Dynamics Information Technology (GDIT). 1401 50th St., Ste. 200, West Des Moines, Iowa, United States.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Morrall', 'Affiliation': 'Senior Consultant, The Lewin Group, 3160 Fairview Park Dr, Falls Church, Virginia, United States.'}]",Health services research,['10.1111/1475-6773.13966']
3190,35238311,Effects of Levosimendan Preconditioning on Left Ventricular Remodeling after Myocardial Reperfusion in Acute Myocardial Infarction Patients Receiving Percutaneous Coronary Intervention.,"OBJECTIVE


Levosimendan is a novel drug often used to treat heart failure. We aimed to explore the effects of levosimendan preconditioning on left ventricular remodeling (LVR) after myocardial reperfusion in acute myocardial infarction (AMI) patients receiving the percutaneous coronary intervention (PCI).
METHODS


A total of 258 AMI patients treated from January 2018 to September 2020 were randomly divided into control and observation groups. Based on conventional drug therapy, levosimendan was given 30 min before PCI for the observation group, and dobutamine was intravenously injected for the control group. Baseline data, thrombolysis in myocardial infarction (TIMI) blood flow grade, myocardial injury markers, and LVR indices were compared, and the influencing factors for LVR were analyzed.
RESULTS


After treatment, various degrees of blood perfusion were found, and the TIMI grade was better than that before treatment in both groups (P < .05). The levels of aspartate aminotransferase, creatine kinase-MB, cardiac troponin T, and brain natriuretic peptide (BNP) declined in both groups, more significantly in the observation group (P < .05). Left ventricular end-systolic diameter, left ventricular end-diastolic diameter and left ventricular end-diastolic volume declined, whereas left ventricular ejection fraction rose in both groups, more significantly in the observation group (P < .05). Age and BNP were risk factors for LVR, whereas levosimendan preconditioning was a protective factor (P < .05).
CONCLUSION


Levosimendan preconditioning can protect cardiac function and promote the recovery of the left ventricular structure. Age and BNP are risk factors for LVR after myocardial reperfusion in AMI patients undergoing PCI, and levosimendan preconditioning is a protective factor.",2022,"After treatment, various degrees of blood perfusion were found, and the TIMI grade was better than that before treatment in both groups (P < .05).","['acute myocardial infarction (AMI) patients receiving the percutaneous coronary intervention (PCI', '258 AMI patients treated from January 2018 to September 2020', 'Acute Myocardial Infarction Patients Receiving Percutaneous Coronary Intervention']","['Levosimendan', 'Levosimendan Preconditioning', 'levosimendan preconditioning', 'levosimendan', 'Levosimendan preconditioning', 'dobutamine']","['left ventricular ejection fraction', 'left ventricular remodeling (LVR', 'Baseline data, thrombolysis in myocardial infarction (TIMI) blood flow grade, myocardial injury markers, and LVR indices', 'levels of aspartate aminotransferase, creatine kinase-MB, cardiac troponin T, and brain natriuretic peptide (BNP', 'Left Ventricular Remodeling', 'blood perfusion', 'Left ventricular end-systolic diameter, left ventricular end-diastolic diameter and left ventricular end-diastolic volume', 'TIMI grade']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C1709632', 'cui_str': 'Precondition'}, {'cui': 'C0012963', 'cui_str': 'Dobutamine'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}]",258.0,0.0222661,"After treatment, various degrees of blood perfusion were found, and the TIMI grade was better than that before treatment in both groups (P < .05).","[{'ForeName': 'Shengqin', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Heart Center, Affiliated Zhongshan Hospital of Dalian University, Dalian, China. lthe6232wdm@163.com.'}, {'ForeName': 'Jindong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Heart Center, Affiliated Zhongshan Hospital of Dalian University, Dalian, China. zhangjdazhdu@163.com.'}]",The heart surgery forum,['10.1532/hsf.4267']
3191,35238652,Perioperative Assessment of Muscle Inflammation Susceptibility in Patients with End-Stage Osteoarthritis.,"Many individuals with end-stage osteoarthritis (OA) undergo elective total hip/knee arthroplasty (THA/TKA) to relieve pain, improve mobility and quality of life. However, ~35% suffer long-term mobility impairment following surgery. This may be in part due to muscle inflammation susceptibility (MuIS+), an overt proinflammatory pathology localized to skeletal muscle surrounding the diseased joint, present in some TKA/THA patients.
PURPOSE


We interrogated the hypothesis that MuIS+ status results in a perturbed perioperative gene expression profile and decreases skeletal muscle integrity in patients with end-stage OA.
METHODS


Samples were leveraged from the two-site, randomized, controlled trial R01HD084124, NCT02628795. Participants were dichotomized based on surgical (SX) muscle gene expression of TNFRSF1A (TNF-aR). MuIS+/- samples were probed for gene expression and fibrosis. Paired and independent two-tailed t-tests were used to determine differences between contralateral (CTRL) and surgical (SX) limbs and between-subject comparisons respectively. Significance was declared at P<0.05.
RESULTS


70 participants (26M/44F; mean age 62.41±8.86yrs; mean body mass index 31.10±4.91kg/m 2 ) undergoing THA/TKA were clustered as MuIS+ (n=24) or MuIS- (n=46). Lower skeletal muscle integrity (greater fibrosis) exists on the SX vs CTRL limb (P<0.001). Further, MuIS+ vs MuIS- muscle exhibited higher proinflammatory (IL-6R, TNF-a) and catabolic (TRIM63) gene expression (P<0.001, P=0.004, and 0.024 respectively), with a trend for greater fibrosis (P=0.087).
CONCLUSIONS


MuIS+ patients exhibit more inflammation and catabolic gene expression in skeletal muscle of the SX limb, accompanied by decreased skeletal muscle integrity (Trend). This highlights the impact of MuIS+ status emphasizing the potential value of perioperative MuIS assessment to inform optimal post-surgical care.",2022,Lower skeletal muscle integrity (greater fibrosis) exists on the SX vs CTRL limb (P<0.001).,"['Patients with End-Stage Osteoarthritis', 'Many individuals with end-stage osteoarthritis (OA) undergo elective total hip', 'patients with end-stage OA', '70 participants (26M/44F; mean age 62.41±8.86yrs', 'Samples were leveraged from the two-site']","['knee arthroplasty (THA/TKA', 'MuIS']","['surgical (SX) muscle gene expression of TNFRSF1A (TNF-aR', 'skeletal muscle integrity', 'proinflammatory (IL-6R, TNF-a) and catabolic (TRIM63) gene expression', 'mobility and quality of life', 'contralateral (CTRL) and surgical (SX) limbs', 'mean body mass index', 'Lower skeletal muscle integrity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0039245', 'cui_str': 'Tacrine'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1453722', 'cui_str': 'TNFRSF1A protein, human'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1699800', 'cui_str': 'IL6R protein, human'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",70.0,0.129038,Lower skeletal muscle integrity (greater fibrosis) exists on the SX vs CTRL limb (P<0.001).,"[{'ForeName': 'Devin J', 'Initials': 'DJ', 'LastName': 'Drummer', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Jeremy S', 'Initials': 'JS', 'LastName': 'McAdam', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Seay', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Aban', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Kaleen M', 'Initials': 'KM', 'LastName': 'Lavin', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Wiggins', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Touliatos', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Sufen', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kelley', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'S Craig', 'Initials': 'SC', 'LastName': 'Tuggle', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Peoples', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Herrick', 'Initials': 'H', 'LastName': 'Siegel', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Ghanem', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Jasvinder', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Schutzler', 'Affiliation': 'Department of Geriatrics and Center for Translational Research in Aging and Longevity, University of Arkansas for Medical Sciences, Little Rock, AR, United States.'}, {'ForeName': 'C Lowry', 'Initials': 'CL', 'LastName': 'Barnes', 'Affiliation': 'Department of Orthopaedic Surgery, University of Arkansas for Medical Sciences, Little Rock, AR, United States.'}, {'ForeName': 'Arny A', 'Initials': 'AA', 'LastName': 'Ferrando', 'Affiliation': 'Department of Geriatrics and Center for Translational Research in Aging and Longevity, University of Arkansas for Medical Sciences, Little Rock, AR, United States.'}, {'ForeName': 'S Louis', 'Initials': 'SL', 'LastName': 'Bridges', 'Affiliation': 'Department of Medicine, Hospital for Special Surgery, New York, NY, United States.'}, {'ForeName': 'Marcas M', 'Initials': 'MM', 'LastName': 'Bamman', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00428.2021']
3192,35238614,Therapeutic Phlebotomy in Patients with Grade 1 Hypertension: A Randomized-Controlled Trial.,"Aim:  Study aim was to investigate the effects of therapeutic phlebotomy on ambulatory blood pressure in patients with grade 1 hypertension.  Methods:  In this randomized-controlled intervention study, patients with unmedicated hypertension grade 1 were randomized into an intervention group (phlebotomy group; 500 mL bloodletting at baseline and after 6 weeks) and a control group (waiting list) and followed up for 8 weeks. Primary endpoint was the 24-h ambulatory mean arterial pressure between the intervention and control groups after 8 weeks. Secondary outcome parameters included ambulatory/resting systolic/diastolic blood pressure, heart rate, and selected laboratory parameters (e.g., hemoglobin, hematocrit, erythrocytes, and ferritin). Resting systolic/diastolic blood pressure/heart rate and blood count were also assessed at 6 weeks before the second phlebotomy to ensure safety. A per-protocol analysis was performed.  Results:  Fifty-three hypertension participants (56.7 ± 10.5 years) were included in the analysis ( n  = 25 intervention group,  n  = 28 control group). The ambulatory measured mean arterial pressure decreased by -1.12 ± 5.16 mmHg in the intervention group and increased by 0.43 ± 3.82 mmHg in the control group (between-group difference: -1.55 ± 4.46,  p  = 0.22). Hemoglobin, hematocrit, erythrocytes, and ferritin showed more pronounced reductions in the intervention group in comparison with the control group, with significant between-group differences. Subgroup analysis showed trends regarding the effects on different groups classified by serum ferritin concentration, body mass index, age, and sex. Two adverse events (AEs) (anemia and dizziness) occurred in association with the phlebotomy, but no serious AEs.  Conclusions:  Study results showed that therapeutic phlebotomy resulted in only minimal reductions of 24-h ambulatory blood pressure measurement values in patients with unmedicated grade 1 hypertension. Further high-quality clinical studies are warranted, as this finding contradicts the results of other studies.",2022,"Hemoglobin, hematocrit, erythrocytes, and ferritin showed more pronounced reductions in the intervention group in comparison with the control group, with significant between-group differences.","['Patients with Grade 1 Hypertension', 'Results:  Fifty-three hypertension participants (56.7\u2009±\u200910.5 years) were included in the analysis ( n \u2009=\u200925 intervention group,  n \u2009=\u200928 control group', 'patients with grade 1 hypertension', 'patients with unmedicated grade 1 hypertension', 'patients with unmedicated hypertension grade 1']","['intervention group (phlebotomy group; 500\u2009mL bloodletting at baseline and after 6 weeks) and a control group (waiting list', 'Therapeutic Phlebotomy', 'therapeutic phlebotomy']","['ambulatory measured mean arterial pressure', '24-h ambulatory mean arterial pressure', 'ambulatory/resting systolic/diastolic blood pressure, heart rate, and selected laboratory parameters (e.g., hemoglobin, hematocrit, erythrocytes, and ferritin', 'serum ferritin concentration, body mass index, age, and sex', 'Hemoglobin, hematocrit, erythrocytes, and ferritin', '24-h ambulatory blood pressure measurement values', 'Resting systolic/diastolic blood pressure/heart rate and blood count', 'ambulatory blood pressure', 'adverse events (AEs) (anemia and dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0005857', 'cui_str': 'Therapeutic phlebotomy'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",,0.0291995,"Hemoglobin, hematocrit, erythrocytes, and ferritin showed more pronounced reductions in the intervention group in comparison with the control group, with significant between-group differences.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jeitler', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Roth', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Steckhan', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Meier', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Daniela A', 'Initials': 'DA', 'LastName': 'Koppold-Liebscher', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Farid I', 'Initials': 'FI', 'LastName': 'Kandil', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ostermann', 'Affiliation': 'Department of Psychology and Psychotherapy, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Stange', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Kessler', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Benno', 'Initials': 'B', 'LastName': 'Brinkhaus', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Michalsen', 'Affiliation': 'Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universitaät zu Berlin, Berlin, Germany.'}]",Journal of integrative and complementary medicine,['10.1089/jicm.2021.0396']
3193,35238494,KinesioTaping after botulinum toxin type A for cervical dystonia in adult patients.,"INTRODUCTION


Studies explored physiotherapeutic approaches in cervical dystonia (CD) patients with or without botulinum toxin (BoNT) injections, however the results are varying. There are no clinical trials investigating the effects of kinesiology taping in CD patients. The objective of this study is to investigate the efficacy of kinesiology taping as an adjunct to the BoNT injections in patients with CD.
METHODS


Twenty-five patients were enrolled to the study. Patients were randomly assigned to the experimental 1 (BoNT + KinesioTaping), experimental 2 (BoNT + ShamTaping) or control (BoNT) treatment. After 12 weeks they were moved to the next experimental group and finally every patient received all 3 proposed treatment options. The severity of CD was quantified with the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) including Torticollis severity, Disability, and Pain scales. Quality of life was evaluated using Craniocervical dystonia questionnaire (CDQ4).
RESULTS


In all treatment groups, there was a significant improvement in dystonia symptoms measured with TWSTRS (total score) after BoNT injection regardless of the allocation to the experimental treatment (p < .05). ANOVA analysis revealed no differences in any of the TWSTRS variables after the intervention. Quality of life was significantly improved after application of taping (p < .05, p = .03).
CONCLUSIONS


Application of KinesioTaping after BoNT injection provided no additional effect on the severity of dystonia, although the quality of life was improved in patients with CD. Further research investigating the effect of KinesioTaping prior to BoNT injection is required.",2022,"Quality of life was significantly improved after application of taping (p < .05, p = .03).
","['CD patients', 'Twenty-five patients were enrolled to the study', 'cervical dystonia in adult patients', 'cervical dystonia (CD) patients with or without', 'patients with CD']","['botulinum toxin (BoNT) injections', 'experimental 1 (BoNT + KinesioTaping), experimental 2 (BoNT + ShamTaping) or control (BoNT) treatment', 'kinesiology taping', 'botulinum toxin type A']","['dystonia symptoms measured with TWSTRS (total score', 'Quality of life', 'severity of dystonia', 'Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) including Torticollis severity, Disability, and Pain scales', 'quality of life', 'Craniocervical dystonia questionnaire (CDQ4', 'severity of CD']","[{'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}]","[{'cui': 'C0013421', 'cui_str': 'Dystonia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}]",25.0,0.0514787,"Quality of life was significantly improved after application of taping (p < .05, p = .03).
","[{'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Dec-Ćwiek', 'Affiliation': 'Department of Neurology, Medical College, Jagiellonian University, Krakow, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Porębska', 'Affiliation': 'Department of Neurology, Medical College, Jagiellonian University, Krakow, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Sawczyńska', 'Affiliation': 'Department of Neurology, Medical College, Jagiellonian University, Krakow, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Kubala', 'Affiliation': 'Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Krakow University, Krakow, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Witkowska', 'Affiliation': 'Department of Neurology, Medical College, Jagiellonian University, Krakow, Poland.'}, {'ForeName': 'Kinga', 'Initials': 'K', 'LastName': 'Zmijewska', 'Affiliation': 'Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Krakow University, Krakow, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Antczak', 'Affiliation': 'Department of Neurology, Medical College, Jagiellonian University, Krakow, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Pera', 'Affiliation': 'Department of Neurology, Medical College, Jagiellonian University, Krakow, Poland.'}]",Brain and behavior,['10.1002/brb3.2541']
3194,35238767,"Whole-body cryotherapy for the treatment of rheumatoid arthritis: a monocentric, single-blinded, randomised controlled trial.","OBJECTIVES


To evaluate effects of whole-body cryotherapy (WBC) in rheumatoid arthritis (RA).
METHODS


Patients with active RA undergoing a 16-day multimodal rheumatologic complex treatment were randomly assigned to either WBC (6 applications in 14 days at -130°C for 3 min) or no treatment. The primary outcome was the difference between groups in pain on a numerical rating scale after intervention. Secondary outcomes assessed effects on i) disease activity, ii) functional capacity, iii) cytokine levels, and iv) use of analgesics.
RESULTS


A total of 56 RA patients completed the trial (intervention group [IG]: 31 patients, control group [CG]: 25 patients). The mean change (± standard error) in pain after intervention was -2 in the IG (95% confidence interval [CI] -2.75 to -1.31, p<0.001) and -0.88 (95% CI -1.43 to -0.33, p=0.003) in the CG, with a baseline-adjusted between-group difference of -1.31 ± 0.4 (95% CI -2.1 to -0.53; p=0.002). Pain at the 12-week follow-up visit remained significantly below baseline values in the IG. Disease activity and functional capacity showed statistically and clinically meaningful improvement after intervention but were not significant at the 12-week follow up. TNF and IL-6 levels changed significantly in the IG. Eighteen of 31 (58%) patients of the IG reduced or discontinued analgesics at the 12-week follow-up. No WBC-related side effects were reported.
CONCLUSIONS


WBC in RA reduces pain and disease activity significantly and in a clinically meaningful manner, resulting in a reduction of analgesics. These effects are potentially based on a change in cytokine levels.",2022,Disease activity and functional capacity showed statistically and clinically,"['Eighteen of 31 (58', 'rheumatoid arthritis (RA', 'Patients with active RA undergoing a 16-day multimodal rheumatologic complex treatment', 'rheumatoid arthritis', '56 RA patients']","['control group [CG', 'whole-body cryotherapy (WBC', 'Whole-body cryotherapy', 'WBC']","['pain on a numerical rating scale', 'TNF and IL-6 levels', 'pain and disease activity', 'Pain', 'Disease activity and functional capacity', 'mean change (± standard error) in pain', 'WBC-related side effects', 'i) disease activity, ii) functional capacity, iii) cytokine levels, and iv) use of analgesics']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",56.0,0.277565,Disease activity and functional capacity showed statistically and clinically,"[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Klemm', 'Affiliation': 'Department of Rheumatology, Clinical Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim, Germany. philipp.klemm@med.uni-giessen.de.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Rheumatology, Clinical Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Asendorf', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Aykara', 'Affiliation': 'Department of Rheumatology, Clinical Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Frommer', 'Affiliation': 'Department of Rheumatology, Clinical Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim, Germany.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Dischereit', 'Affiliation': 'Rheumatologische Schwerpunktpraxis Marburg, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Müller-Ladner', 'Affiliation': 'Department of Rheumatology, Clinical Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Neumann', 'Affiliation': 'Department of Rheumatology, Clinical Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Lange', 'Affiliation': 'Department of Rheumatology, Clinical Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim, Germany.'}]",Clinical and experimental rheumatology,[]
3195,35238765,Symptomatic and structural benefit of cathepsin K inhibition by MIV-711 in a subgroup with unilateral pain: post-hoc analysis of a randomised phase 2a clinical trial.,"OBJECTIVES


Osteoarthritis (OA) development programmes face challenges due to discordance between structural changes and symptoms. A novel cathepsin-K inhibitor, MIV-711, recently reported structural benefits, but did not demonstrate a significant difference from placebo in symptoms. Previous work suggests that pain from non-target joints may confound OA pain outcomes. We therefore conducted an exploratory analysis in participants with predominantly unilateral knee pain from the MIV-711-201 trial.
METHOSD


Participants scoring below median contralateral knee NRS pain at baseline from the MIV-711-201 phase 2a clinical trial (n=119) were analysed by treatment group for differences in change from baseline in WOMAC pain, quantitative magnetic resonance imaging bone area and cartilage thickness with a repeated-measures mixed model adjusting for relevant co-variates.
RESULTS


In the subgroup with unilateral knee pain, treatment with MIV-711 100 mg led to greater reduction in WOMAC pain compared to placebo (-5.0, 95% CI: -8.69 to -1.3, p=0.008), while 200 mg did not (-2.5, 95% CI: -6.5 to 1.6, p=0.23). MIV-711 treatment was associated with a reduced change in bone area compared to placebo (200 mg; -19.6 mm2 , 95% CI: -36.2 to -3.0, p=0.02, and 100 mg; -12.5 mm2 , 95% CI: -27.8 to 2.8, p=0.11,). No observed differences between treatment groups in cartilage thickness were found in this subgroup.
CONCLUSIONS


In a subgroup with predominantly unilateral knee pain, significant reduction in OA pain by MIV-711 100 mg treatment was found, with concurrent beneficial structural effects, highlighting the importance of appropriate pain inclusion criteria in OA trials.",2022,"MIV-711 treatment was associated with a reduced change in bone area compared to placebo (200 mg; -19.6 mm2 , 95% CI: -36.2 to -3.0, p=0.02, and 100 mg; -12.5 mm2 , 95% CI: -27.8 to 2.8, p=0.11,).","['subgroup with unilateral pain', 'participants with predominantly unilateral knee pain from the MIV-711-201 trial', 'Participants scoring below median contralateral knee NRS pain at baseline from the MIV-711-201 phase 2a clinical trial (n=119']","['MIV-711', 'cathepsin K inhibition by MIV-711', 'placebo']","['change in bone area', 'cartilage thickness', 'OA pain', 'WOMAC pain', 'WOMAC pain, quantitative magnetic resonance imaging bone area and cartilage thickness']","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C5197411', 'cui_str': 'MIV-711'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C5197411', 'cui_str': 'MIV-711'}, {'cui': 'C0284930', 'cui_str': 'Cathepsin K'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",119.0,0.617045,"MIV-711 treatment was associated with a reduced change in bone area compared to placebo (200 mg; -19.6 mm2 , 95% CI: -36.2 to -3.0, p=0.02, and 100 mg; -12.5 mm2 , 95% CI: -27.8 to 2.8, p=0.11,).","[{'ForeName': 'Asger Reinstrup', 'Initials': 'AR', 'LastName': 'Bihlet', 'Affiliation': 'NBCD A/S, Herlev, Denmark. abi@nbcd.com.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Byrjalsen', 'Affiliation': 'NBCD A/S, Herlev, Denmark.'}, {'ForeName': 'Jeppe Ragnar', 'Initials': 'JR', 'LastName': 'Andersen', 'Affiliation': 'NBCD A/S, Herlev, Denmark.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Öberg', 'Affiliation': 'Medivir AB, Huddinge, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Herder', 'Affiliation': 'Medivir AB, Huddinge, Sweden.'}, {'ForeName': 'Mike A', 'Initials': 'MA', 'LastName': 'Bowes', 'Affiliation': 'iMorphics, Manchester, UK.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, UK.'}]",Clinical and experimental rheumatology,[]
3196,35238725,Clinical pharmacology considerations for the approval of belimumab for the treatment of adult patients with active lupus nephritis: A regulatory perspective.,"On 16 December 2020, FDA approved Benlysta® (belimumab) for both the intravenous (IV) and subcutaneous (SC) administration routes for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. This approval represents the first FDA approved treatment of patients with active LN.The approved IV dosing regimen (10 mg/kg dose Q2W for three doses, then 10 mg/kg Q4W thereafter) was based on a randomized double-blind placebo controlled clinical trial in adult patients with LN. For the approval of the SC dosing regimen (400 mg dose QW for four doses, then 200 mg QW thereafter), efficacy was supported solely by pharmacokinetics (PK) modeling and simulation which estimated a matched steady state average concentration and higher trough concentrations for the SC administration route, for bridging to the efficacy of IV belimumab in adults with LN. The safety and immunogenicity profile of the SC administration route has been assessed in the SLE studies.In a population PK analysis, higher proteinuria was associated with greater belimumab clearance and lower belimumab exposure. In an exposure response analysis, the efficacy of belimumab as evaluated by renal response was mainly driven by patients with lower proteinuria at baseline regardless of other baseline characteristics (e.g. baseline renal function, renal biopsy classification), induction therapies, or belimumab exposure levels (within 10 mg/kg dosing regimen), etc. However, post hoc analyses showed that belimumab had activity in LN patients with higher proteinuria at baseline. There is no adequate information to suggest that a higher dose would provide additional benefit for patients with lower exposure (e.g. higher proteinuria).",2022,"However, post hoc analyses showed that belimumab had activity in LN patients with higher proteinuria at baseline.","['adult patients with active lupus nephritis', 'adult patients with active lupus nephritis (LN) who are receiving standard therapy', 'adult patients with LN', 'patients with lower proteinuria at baseline regardless of other baseline characteristics (e.g. baseline renal function, renal biopsy classification), induction therapies, or belimumab exposure levels (within 10\xa0mg/kg dosing regimen), etc', 'adults with LN']",['placebo'],['renal response'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0194073', 'cui_str': 'Kidney biopsy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",,0.306848,"However, post hoc analyses showed that belimumab had activity in LN patients with higher proteinuria at baseline.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Neuner', 'Affiliation': 'Division of Rheumatology and Transplant Medicine, Office of Immunology and Inflammation, Office of New Drug, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Division of Cardiology and Nephrology, Office of Cardiology, Hematology, Endocrinology and Nephrology, Office of New Drug, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Ginto', 'Initials': 'G', 'LastName': 'Pottackal', 'Affiliation': 'Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Petullo', 'Affiliation': 'Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Nikolay', 'Initials': 'N', 'LastName': 'Nikolov', 'Affiliation': 'Division of Rheumatology and Transplant Medicine, Office of Immunology and Inflammation, Office of New Drug, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Chandrahas', 'Initials': 'C', 'LastName': 'Sahajwalla', 'Affiliation': 'Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Doddapaneni', 'Affiliation': 'Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Jianmeng', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, 4137Food and Drug Administration, Silver Spring, MD, USA.'}]",Lupus,['10.1177/09612033221079771']
3197,35238704,Plasmalyte-A Based del Nido Cardioplegia Versus Plain Ringer Based del Nido Cardioplegia: Double-Blind Randomized Trial.,"Background:  In this prospective randomized controlled trial, we compared the standard del Nido cardioplegia solution (SDN) with the modified del Nido cardioplegia solution (MDN) in which the base solution was the plain Ringer solution.  Methods:  A total of 80 patients aged < 12 years undergoing intracardiac repair of Tetralogy of Fallot were randomized into SDN (n = 39) or MDN (n = 41) groups. The primary outcome was a change in cardiac index (CI). Secondary outcomes were ventricular arrhythmias after the release of aortic-cross clamp, postoperative inotropic score (IS), time to peripheral rewarming, duration of mechanical ventilation, intensive care unit (ICU) length of stay, and hospital length of stay, and electron microscopic differences between the 2 groups. Cardiac Troponin-I, inflammatory markers tumor necrosis factor-α (TNF-α), and interleukin-L (IL-6) were measured.  Results:  Applying the noninferiority confidence interval approach, the difference between the changes in CI between the 2 groups was -0.093 L/min/m2 (95% CI: -0.46-0.27 L/min/m2) which was within the noninferiority threshold of -0.5 indicating that CI was similar in both SDN and MDN. Ventricular arrhythmias postclamp release ( P  = .91), IS ( P  = .09), duration of mechanical ventilation ( P  = .27), ICU length of stay ( P  = .50), hospital length of stay ( P   =  .57), IL-6 ( P  = .19), TNF-α ( P  = .17), Troponin-I ( P  = .15), electron microscopy changes ( P  > .05) were not different between groups.  Conclusion:  MDN was shown to be noninferior to the SDN cardioplegia in terms of preservation of cardiac index. In addition, other metrics indicative of myocardial protection were similar between groups. In developing nations where SDN is not available or is expensive, MDN cardioplegia is an acceptable alternative.",2022,"TNF-α ( P  = .17), Troponin-I ( P  = .15), electron microscopy changes ( P  > .05) were not different between groups.  ",['80 patients aged < 12 years undergoing intracardiac repair of Tetralogy of Fallot'],"['MDN', 'Cardioplegia Versus Plain Ringer Based del Nido Cardioplegia', 'Plasmalyte-A Based del Nido', 'standard del Nido cardioplegia solution (SDN) with the modified del Nido cardioplegia solution (MDN', 'SDN cardioplegia', 'SDN']","['ventricular arrhythmias after the release of aortic-cross clamp, postoperative inotropic score (IS), time to peripheral rewarming, duration of mechanical ventilation, intensive care unit (ICU) length of stay, and hospital length of stay, and electron microscopic differences', 'ICU length of stay', 'electron microscopy changes', 'Cardiac Troponin-I, inflammatory markers tumor necrosis factor-α (TNF-α), and interleukin-L (IL-6', 'hospital length of stay', 'myocardial protection', 'IL-6', 'Troponin-I', 'Ventricular arrhythmias postclamp release', 'TNF-α', 'duration of mechanical ventilation', 'change in cardiac index (CI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0729936', 'cui_str': 'Cardiac chamber structure'}, {'cui': 'C0397326', 'cui_str': 'Repair of tetralogy of Fallot'}]","[{'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0071213', 'cui_str': 'Plasmalyte A'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007200', 'cui_str': 'cardioplegia solutions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038642', 'cui_str': 'Sudan'}]","[{'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0206156', 'cui_str': 'Rewarming'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0013852', 'cui_str': 'Electron'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}]",80.0,0.285859,"TNF-α ( P  = .17), Troponin-I ( P  = .15), electron microscopy changes ( P  > .05) were not different between groups.  ","[{'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Talwar', 'Affiliation': '422637All India Institute of Medical Sciences Cardio-Thoracic Sciences Centre, New Delhi, India.'}, {'ForeName': 'Niraghatam', 'Initials': 'N', 'LastName': 'Harshavardhan', 'Affiliation': '422637All India Institute of Medical Sciences Cardio-Thoracic Sciences Centre, New Delhi, India.'}, {'ForeName': 'Poonam M', 'Initials': 'PM', 'LastName': 'Kapoor', 'Affiliation': '28730All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Neeti', 'Initials': 'N', 'LastName': 'Makhija', 'Affiliation': '28730All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Palleti', 'Initials': 'P', 'LastName': 'Rajashekar', 'Affiliation': '28730All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vishnubhatla', 'Initials': 'V', 'LastName': 'Sreenivas', 'Affiliation': '28730All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashish D', 'Initials': 'AD', 'LastName': 'Upadhyay', 'Affiliation': '28730All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Sahu', 'Affiliation': '422637All India Institute of Medical Sciences Cardio-Thoracic Sciences Centre, New Delhi, India.'}, {'ForeName': 'Shiv K', 'Initials': 'SK', 'LastName': 'Choudhary', 'Affiliation': '422637All India Institute of Medical Sciences Cardio-Thoracic Sciences Centre, New Delhi, India.'}]",World journal for pediatric & congenital heart surgery,['10.1177/21501351211073610']
3198,35239204,Finerenone in patients with CKD and T2D with and without heart failure: A prespecified subgroup analysis of the FIDELIO-DKD trial.,"AIMS


This prespecified analysis of the FIDELIO-DKD trial compared the effects of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiorenal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) by history of heart failure (HF).
METHODS


Patients with T2D and CKD (urine albumin-to-creatinine ratio ≥ 30-5000 mg/g and estimated glomerular filtration rate (eGFR) ≥25-<75 mL/min/1.73 m 2  ), without symptomatic HF with reduced ejection fraction (New York Heart Association II-IV) and treated with optimized renin-angiotensin system blockade were randomized to finerenone or placebo. The composite cardiovascular (CV) outcome (CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for HF) and composite kidney outcome (kidney failure, sustained ≥40% decrease in eGFR from baseline, or renal death) were analysed by investigator-reported medical history of HF.
RESULTS


Of 5674 patients, 436 (7.7%) had a history of HF. Over a median follow-up of 2.6 years, the effect of finerenone compared with placebo on the composite CV outcome was consistent in patients with and without a history of HF (hazard ratio [HR] 0.73 [95% confidence interval (CI) 0.50-1.06] and 0.90 [95% CI 0.77-1.04], respectively; interaction P = 0.33). The effect of finerenone on the composite kidney outcome did not differ by history of HF (HR 0.79 [95% CI 0.52-1.20] and 0.83 [95% CI 0.73-0.94], respectively; interaction P = 0.83).
CONCLUSION


In FIDELIO-DKD, finerenone improved cardiorenal outcome in patients with CKD and T2D irrespective of baseline HF history. This article is protected by copyright. All rights reserved.",2022,The effect of finerenone on the composite kidney outcome did not differ by history of HF (HR 0.79,"['patients with CKD and T2D with and without heart failure', 'patients with CKD and T2D irrespective of baseline HF history', 'Of 5674 patients, 436 (7.7%) had a history of HF', 'patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) by history of heart failure (HF', 'Patients with T2D and CKD (urine albumin-to-creatinine ratio\u2009≥\u200930-5000\u2009mg/g and estimated glomerular filtration rate (eGFR) ≥25-<75']","['finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist', 'placebo', 'finerenone or placebo', 'finerenone', 'In FIDELIO-DKD', 'Finerenone']","['composite kidney outcome', 'cardiorenal outcome', 'composite CV outcome', 'composite cardiovascular (CV) outcome (CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for HF) and composite kidney outcome (kidney failure, sustained ≥40% decrease in eGFR from baseline, or renal death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C4045511', 'cui_str': 'finerenone'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",5674.0,0.401654,The effect of finerenone on the composite kidney outcome did not differ by history of HF (HR 0.79,"[{'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Farmakis', 'Affiliation': 'University of Cyprus Medical School, Nicosia, Cyprus.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Ruilope', 'Affiliation': 'Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Bauersachs', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kolkhof', 'Affiliation': 'Research and Development, Preclinical Research Cardiovascular, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Scott', 'Affiliation': 'Data Science and Analytics, Bayer PLC, Reading, UK.'}, {'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Joseph', 'Affiliation': 'Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany.'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, University of Chicago Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK) and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.2469']
3199,34726703,Kinetics of iron absorption from ferrous fumarate with and without galacto-oligosaccharides determined from stable isotope appearance curves in women.,"BACKGROUND


Prebiotic galacto-oligosaccharides (GOS) are novel enhancers of iron absorption from ferrous fumarate (FeFum). However, the mechanism(s) of this effect, and whether it occurs in the proximal or distal gut, are uncertain.
OBJECTIVES


We studied: 1) in vitro, the effect of GOS on iron solubility and dialyzability from FeFum; 2) in volunteers, the absorption kinetics of FeFum given with and without GOS using stable isotope appearance curves (SIAC).
METHODS


We measured iron solubility at various pH and dialyzability from FeFum with and without GOS. In crossover design, iron-depleted women [n = 11; median serum ferritin (SF) 15.2; IQR: 12.6-21.2 µg/L] received 2 14-mg iron doses as labeled (57Fe,58Fe) FeFum 14 d apart with and without 15 g GOS in randomly assigned order. Multiple blood samples were collected over a time period of 24 h and 14 d later to determine SIAC and fractional iron absorption (FIA), respectively. SIAC data were fitted using nonlinear mixed effects modeling to a 1-compartment model with first-order absorption, and AUC and time of peak serum isotope concentration (tmax) were calculated.
RESULTS


Iron dialyzability was 75% higher with GOS (P < 0.001) and iron solubility was more than doubled at pH 4 and 6 with GOS [both P < 0.001]. Mean ± SD AUC (5830.9 ± 4717.3 μg/min with GOS, 4454.0 ± 3260.7 μg/min for control), and median (IQR) FIA (20.3% (8.6%-38.7%) with GOS, and 15.6% (10.6%-24.8% f)or control) were not different with compared to without GOS (P = 0.064; P = 0.080). Mean ±SD tmax was not altered with GOS (3.08 ± 0.47 h with GOS; 2.80 ±0.50 h for control; P = 0.096). Iron bioavailability significantly increased with decreasing SF and this effect was significantly enhanced by GOS (P = 0.037, interaction of GOS with SF).
CONCLUSIONS


GOS increases iron solubility from FeFum at physiological pH characteristic of the proximal duodenum. The absorption kinetics in vivo are consistent with effects on iron absorption in the proximal, rather than distal, parts of the gut. There was no overall effect of GOS on FIA in vivo, but the interaction of GOS and SF on FIA might benefit iron-deficient women, an effect potentially mediated by the higher solubility shown in vitro. This study was registered at clinicaltrials.gov as NCT03996421.",2022,"Iron bioavailability significantly increased with decreasing SF and this effect was significantly enhanced by GOS (P = 0.037, interaction of GOS with SF).
","['women', 'iron-depleted women [n = 11; median serum ferritin (SF) 15.2; IQR: 12.6-21.2 µg/L']","['iron absorption from ferrous fumarate with and without galacto-oligosaccharides', 'Prebiotic galacto-oligosaccharides (GOS', '2 14-mg iron doses as labeled (57Fe,58Fe', 'GOS']","['Mean ±SD tmax', 'GOS', 'SD AUC (5830.9\xa0±', 'absorption kinetics of FeFum given with and without GOS using stable isotope appearance curves (SIAC', 'Iron bioavailability', 'Mean\xa0±', 'iron solubility', 'median (IQR) FIA', 'AUC and time of peak serum isotope concentration (tmax', 'Iron dialyzability', 'Multiple blood samples']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C4517545', 'cui_str': '12.6'}]","[{'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0060276', 'cui_str': 'Ferrous fumarate'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0060276', 'cui_str': 'Ferrous fumarate'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0037628', 'cui_str': 'Solubility'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0022262', 'cui_str': 'Isotope'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.0502191,"Iron bioavailability significantly increased with decreasing SF and this effect was significantly enhanced by GOS (P = 0.037, interaction of GOS with SF).
","[{'ForeName': 'Frederike M D', 'Initials': 'FMD', 'LastName': 'Husmann', 'Affiliation': 'Laboratory of Human Nutrition, Institute of Food, Nutrition and Health, ETH Zurich, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Stierli', 'Affiliation': 'Laboratory of Human Nutrition, Institute of Food, Nutrition and Health, ETH Zurich, Switzerland.'}, {'ForeName': 'Dominic S', 'Initials': 'DS', 'LastName': 'Bräm', 'Affiliation': 'Institute of Pharmaceutical Sciences, Department of Chemistry and Applied Biosciences, ETH Zurich, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Zeder', 'Affiliation': 'Laboratory of Human Nutrition, Institute of Food, Nutrition and Health, ETH Zurich, Switzerland.'}, {'ForeName': 'Stefanie D', 'Initials': 'SD', 'LastName': 'Krämer', 'Affiliation': 'Institute of Pharmaceutical Sciences, Department of Chemistry and Applied Biosciences, ETH Zurich, Switzerland.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Zimmermann', 'Affiliation': 'Laboratory of Human Nutrition, Institute of Food, Nutrition and Health, ETH Zurich, Switzerland.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Herter-Aeberli', 'Affiliation': 'Laboratory of Human Nutrition, Institute of Food, Nutrition and Health, ETH Zurich, Switzerland.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab361']
3200,34355879,Efficacy of the Novel Degludec/Aspart Insulin Co-formulation in Children and Adolescents with Type 1 Diabetes: A Real-life Experience with One Year of IDegAsp Therapy in Poorly Controlled and Non-compliant Patients,"Objective


To evaluate the efficacy of degludec/aspart (IDegAsp) insulin co-formulation in children and adolescents with poorly controlled type 1 diabetes (T1DM).
Methods


Patients with poorly controlled T1DM on basal-bolus insulin regimes and having compliance problems related to insulin injections were switched to IDegAsp and were included. Data on hemoglobin A1c (HbA1c) levels, hypoglycemic episodes, frequency of diabetic ketoacidosis (DKA) and insulin doses were recorded at baseline and after one year of IDegAsp treatment.
Results


Fifty patients (22 girls; 44%) were started on IDegAsp. The mean±standard deviation (range) age and duration of diabetes were 12.9±3.4 (4-18) and 5.2±3.1 (1.0-13.7) years, respectively. At the end of one year, 38 patients were still on IDegAsp, whereas 12 patients had opted to resume their original treatments. In those who continued on IDegAsp, HbA1c levels did not change, but the number of self-reported mild-moderate hypoglycemic episodes decreased significantly (p<0.05). In the year before switching to IDegAsp, 11 DKA attacks in 9 patients were observed, whereas this decreased to 4 DKA attacks in 4 patients after one year of IDegAsp therapy (p=0.06).
Conclusion


IDegAsp regimen may improve clinical management in poorly controlled basal-bolus insulin regimen T1DM patients who have frequent hypoglycemia and DKA attacks, as well as in those with poor compliance with multiple injections. Although a simplified basal-bolus IDegAsp regimen is an attractive option for patients with T1DM, some may not adapt to this treatment due to the fixed IAsp dose of IDegAsp.",2022,"In those who continued on IDegAsp, HbA1c levels did not change, but the number of self-reported mild-moderate hypoglycemic episodes decreased significantly (p<0.05).","['children and adolescents with poorly controlled type 1 diabetes (T1DM', 'Fifty patients (22 girls; 44%) were started on IDegAsp', 'patients with T1DM', 'Methods\n\n\nPatients with poorly controlled T1DM on basal-bolus insulin regimes and having compliance problems related to insulin injections were switched to IDegAsp and were included', '38 patients were still on IDegAsp, whereas 12 patients had opted to resume their original treatments', 'Children and Adolescents with Type 1 Diabetes']","['Novel Degludec/Aspart Insulin Co-formulation', 'degludec/aspart (IDegAsp) insulin co-formulation']","['mean±standard deviation (range) age and duration of diabetes', 'HbA1c levels', 'number of self-reported mild-moderate hypoglycemic episodes', 'DKA attacks', 'hemoglobin A1c (HbA1c) levels, hypoglycemic episodes, frequency of diabetic ketoacidosis (DKA) and insulin doses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0557978', 'cui_str': 'Insulin regime'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",50.0,0.0427532,"In those who continued on IDegAsp, HbA1c levels did not change, but the number of self-reported mild-moderate hypoglycemic episodes decreased significantly (p<0.05).","[{'ForeName': 'Tarık', 'Initials': 'T', 'LastName': 'Kırkgöz', 'Affiliation': 'Marmara University Faculty of Medicine, Department of Pediatric Endocrinology, İstanbul, Turkey'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Eltan', 'Affiliation': 'Marmara University Faculty of Medicine, Department of Pediatric Endocrinology, İstanbul, Turkey'}, {'ForeName': 'Sare Betül', 'Initials': 'SB', 'LastName': 'Kaygusuz', 'Affiliation': 'Marmara University Faculty of Medicine, Department of Pediatric Endocrinology, İstanbul, Turkey'}, {'ForeName': 'Zehra', 'Initials': 'Z', 'LastName': 'Yavaş Abalı', 'Affiliation': 'Marmara University Faculty of Medicine, Department of Pediatric Endocrinology, İstanbul, Turkey'}, {'ForeName': 'Didem', 'Initials': 'D', 'LastName': 'Helvacıoğlu', 'Affiliation': 'Marmara University Faculty of Medicine, Department of Pediatric Endocrinology, İstanbul, Turkey'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Seven Menevşe', 'Affiliation': 'Marmara University Faculty of Medicine, Department of Pediatric Endocrinology, İstanbul, Turkey'}, {'ForeName': 'Büşra', 'Initials': 'B', 'LastName': 'Gürpınar Tosun', 'Affiliation': 'Marmara University Faculty of Medicine, Department of Pediatric Endocrinology, İstanbul, Turkey'}, {'ForeName': 'Tülay', 'Initials': 'T', 'LastName': 'Güran', 'Affiliation': 'Marmara University Faculty of Medicine, Department of Pediatric Endocrinology, İstanbul, Turkey'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Bereket', 'Affiliation': 'Marmara University Faculty of Medicine, Department of Pediatric Endocrinology, İstanbul, Turkey'}, {'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Turan', 'Affiliation': 'Marmara University Faculty of Medicine, Department of Pediatric Endocrinology, İstanbul, Turkey'}]",Journal of clinical research in pediatric endocrinology,['10.4274/jcrpe.galenos.2021.2021.0113']
3201,35011579,Decrease of Pro-Angiogenic Monocytes Predicts Clinical Response to Anti-Angiogenic Treatment in Patients with Metastatic Renal Cell Carcinoma.,"The modulation of subpopulations of pro-angiogenic monocytes (VEGFR-1 + CD14 and Tie2 + CD14) was analyzed in an ancillary study from the prospective PazopanIb versus Sunitinib patient preferenCE Study (PISCES) (NCT01064310), where metastatic renal cell carcinoma (mRCC) patients were treated with two anti-angiogenic drugs, either sunitinib or pazopanib. Blood samples from 86 patients were collected prospectively at baseline (T1), and at 10 weeks (T2) and 20 weeks (T3) after starting anti-angiogenic therapy. Various subpopulations of myeloid cells (monocytes, VEGFR-1 + CD14 and Tie2 + CD14 cells) decreased during treatment. When patients were divided into two subgroups with a decrease (defined as a >20% reduction from baseline value) (group 1) or not (group 2) at T3 for VEGFR-1 + CD14 cells, group 1 patients presented a median PFS and OS of 24 months and 37 months, respectively, compared with a median PFS of 9 months ( p  = 0.032) and a median OS of 16 months ( p  = 0.033) in group 2 patients. The reduction in Tie2 + CD14 at T3 predicted a benefit in OS at 18 months after therapy ( p  = 0.04). In conclusion, in this prospective clinical trial, a significant decrease in subpopulations of pro-angiogenic monocytes was associated with clinical response to anti-angiogenic drugs in patients with mRCC.",2021,"The modulation of subpopulations of pro-angiogenic monocytes (VEGFR-1 + CD14 and Tie2 + CD14) was analyzed in an ancillary study from the prospective PazopanIb versus Sunitinib patient preferenCE Study (PISCES) (NCT01064310), where metastatic renal cell carcinoma (mRCC) patients were treated with two anti-angiogenic drugs, either sunitinib or pazopanib.","['patients with mRCC', 'metastatic renal cell carcinoma (mRCC) patients', 'Patients with Metastatic Renal Cell Carcinoma']",['sunitinib or pazopanib'],"['subpopulations of pro-angiogenic monocytes', 'reduction in Tie2 + CD14', 'myeloid cells (monocytes, VEGFR-1 + CD14 and Tie2 + CD14 cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}]","[{'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0596993', 'cui_str': 'Stem Cells, Myeloid'}, {'cui': 'C0378516', 'cui_str': 'Proto-Oncogene Protein flt'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",86.0,0.0374657,"The modulation of subpopulations of pro-angiogenic monocytes (VEGFR-1 + CD14 and Tie2 + CD14) was analyzed in an ancillary study from the prospective PazopanIb versus Sunitinib patient preferenCE Study (PISCES) (NCT01064310), where metastatic renal cell carcinoma (mRCC) patients were treated with two anti-angiogenic drugs, either sunitinib or pazopanib.","[{'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'APHP, Hôpital Européen Georges Pompidou, INSERM U970, PARCC, Université de Paris, 75020 Paris, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Benhamouda', 'Affiliation': 'APHP, Hôpital Européen Georges Pompidou, INSERM U970, PARCC, Université de Paris, 75020 Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Department of Medical Oncology, Institut Gustave Roussy, CEDEX, 94805 Villejuif, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Ravel', 'Affiliation': ""Cancer Bioinformatics and Systems Biology, Institut de Recherche en Cancérologie de Montpellier, Campus Val d'Aurelle, Université Montpellier, CEDEX 5, 34298 Montpellier, France.""}, {'ForeName': 'Thi', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': 'APHP, Hôpital Européen Georges Pompidou, INSERM U970, PARCC, Université de Paris, 75020 Paris, France.'}, {'ForeName': 'Emeline', 'Initials': 'E', 'LastName': 'Levionnois', 'Affiliation': 'APHP, Hôpital Européen Georges Pompidou, INSERM U970, PARCC, Université de Paris, 75020 Paris, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Negrier', 'Affiliation': 'Centre Léon Bérard Lyon, University Lyon 1, 69008 Lyon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Barthelemy', 'Affiliation': 'Institut de Cancérologie Strasbourg Europe, Strasbourg University Hospital, 67200 Strasbourg, France.'}, {'ForeName': 'Jean François', 'Initials': 'JF', 'LastName': 'Berdah', 'Affiliation': 'Medical Oncology Unit, Hôpital Privé Toulon-Hyères, Sainte-Marguerite, 83400 Hyeres, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Gross-Goupil', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, 31000 Bordeaux, France.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Weill Cornell Medicine, Sandra and Edward Meyer Cancer, New York, NY 10065, USA.'}, {'ForeName': 'Petri', 'Initials': 'P', 'LastName': 'Bono', 'Affiliation': 'Kamppi Hospital Department, Terveystalo Finland, 00100 Helsinki, Finland.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Division of Translational Oncology, IRCCS San Matteo University Hospital, 27100 Pavia, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, 47014 Meldola, Italy.'}, {'ForeName': 'Omi', 'Initials': 'O', 'LastName': 'Parikh', 'Affiliation': 'Department of Oncology, Lancashire Teaching Hospitals NHS Foundation Trust, Preston PR2 9HT, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hawkins', 'Affiliation': 'Institute of Cancer Sciences, University of Manchester, Manchester M13 9PL, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Highley', 'Affiliation': 'Oncology Centre, Derriford Hospital, Plymouth PL6 8DH, UK.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wilke', 'Affiliation': 'Gemeinschaftspraxis Dres. Wilke/Wagner/Petzoldt, 90766 Fuerth, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Decker', 'Affiliation': 'Studienzentrum Onkologie, Practice for Hematology and Oncology, 88212 Ravensburg, Germany.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Tanchot', 'Affiliation': 'APHP, Hôpital Européen Georges Pompidou, INSERM U970, PARCC, Université de Paris, 75020 Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Gey', 'Affiliation': 'APHP, Hôpital Européen Georges Pompidou, INSERM U970, PARCC, Université de Paris, 75020 Paris, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Terme', 'Affiliation': 'APHP, Hôpital Européen Georges Pompidou, INSERM U970, PARCC, Université de Paris, 75020 Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tartour', 'Affiliation': 'APHP, Hôpital Européen Georges Pompidou, INSERM U970, PARCC, Université de Paris, 75020 Paris, France.'}]",Cells,['10.3390/cells11010017']
3202,35130320,Healthcare providers experiences with shared medical appointments for heart failure.,"Shared medical appointments (SMAs) offer a means for providing knowledge and skills needed for chronic disease management to patients. However, SMAs require a time and attention investment from health care providers, who must understand the goals and potential benefits of SMAs from the perspective of patients and providers. To better understand how to gain provider engagement and inform future SMA implementation, qualitative inquiry of provider experience based on a knowledge-attitude-practice model was explored. Semi-structured interviews were conducted with 24 health care providers leading SMAs for heart failure at three Veterans Administration Medical Centers. Rapid matrix analysis process techniques including team-based qualitative inquiry followed by stakeholder validation was employed. The interview guide followed a knowledge-attitude-practice model with a priori domains of knowledge of SMA structure and content (understanding of how SMAs were structured), SMA attitude/beliefs (general expectations about SMA use), attitudes regarding how leading SMAs affected patients, and providers. Data regarding the patient referral process (organizational processes for referring patients to SMAs) and suggested improvements were collected to further inform the development of SMA implementation best practices. Providers from all three sites reported similar knowledge, attitude and beliefs of SMAs. In general, providers reported that the multi-disciplinary structure of SMAs was an effective strategy towards improving clinical outcomes for patients. Emergent themes regarding experiences with SMAs included improved self-efficacy gained from real-time collaboration with providers from multiple disciplines, perceived decrease in patient re-hospitalizations, and promotion of self-management skills for patients with HF. Most providers reported that the SMA-setting facilitated patient learning by providing opportunities for the sharing of experiences and knowledge. This was associated with the perception of increased comradery and support among patients. Future research is needed to test suggested improvements and to develop best practices for training additional sites to implement HF SMA.",2022,Shared medical appointments (SMAs) offer a means for providing knowledge and skills needed for chronic disease management to patients.,"['Healthcare providers experiences with shared medical appointments for heart failure', 'Semi-structured interviews were conducted with 24 health care providers leading SMAs for heart failure at three Veterans Administration Medical Centers']",[],"['self-efficacy', 'knowledge, attitude and beliefs of SMAs', 'patient re-hospitalizations, and promotion of self-management skills']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C5197873', 'cui_str': 'Shared Medical Appointments'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]",[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]",,0.0648902,Shared medical appointments (SMAs) offer a means for providing knowledge and skills needed for chronic disease management to patients.,"[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Marshall', 'Affiliation': 'Research, VA Northeast Ohio Healthcare System, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Jeri', 'Initials': 'J', 'LastName': 'Jewett-Tennant', 'Affiliation': 'Health System Education/Opioid Data 2 Action, The Center for Health Affairs, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Jeneen', 'Initials': 'J', 'LastName': 'Shell-Boyd', 'Affiliation': 'Research, VA Northeast Ohio Healthcare System, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Stevenson', 'Affiliation': 'Research, VA Northeast Ohio Healthcare System, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Hearns', 'Affiliation': 'Research, VA Northeast Ohio Healthcare System, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Gee', 'Affiliation': 'Research, VA Northeast Ohio Healthcare System, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Schaub', 'Affiliation': 'Research, VA Northeast Ohio Healthcare System, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'LaForest', 'Affiliation': 'Research, VA Northeast Ohio Healthcare System, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Tracey H', 'Initials': 'TH', 'LastName': 'Taveira', 'Affiliation': 'Medicine, Providence VA Medical Center, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Medicine, Providence VA Medical Center, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Parent', 'Affiliation': 'Medicine, Providence VA Medical Center, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Sandesh', 'Initials': 'S', 'LastName': 'Dev', 'Affiliation': 'Medicine, Southern Arizona VA Health Care System, Tucson, Arizona, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Barrette', 'Affiliation': 'Medicine, Providence VA Medical Center, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Oliver', 'Affiliation': 'Medicine, Providence VA Medical Center, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Wen-Chih', 'Initials': 'WC', 'LastName': 'Wu', 'Affiliation': 'Medicine, Providence VA Medical Center, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'Ball', 'Affiliation': 'Research, VA Northeast Ohio Healthcare System, Cleveland, Ohio, United States of America.'}]",PloS one,['10.1371/journal.pone.0263498']
3203,35239448,Sexually transmitted infections among participants in an HIV PrEP adherence trial.,"BACKGROUND


HIV PrEP effectiveness is highly dependent on adherence. High STI incidence has been reported among PrEP users. We assessed the relationship between STI incidence (CT, NG, and syphilis) and PrEP adherence.
METHODS


We performed a subanalysis of a controlled, open-label, two-arm, randomized clinical demonstration project of a text-message based adherence intervention. Participants had 48 weeks of follow-up and had STI testing every 12 or 24 weeks. PrEP adherence was measured at week 48 using intracellular tenofovir-diphosphate drug concentrations. We calculated incidence rate ratios for STIs among those adherent as compared with those not adherent to PrEP.
RESULTS


Of the 381 assessed for CT, NG and syphilis at one or more follow-up visits, there were 16 cases of syphilis or 5.0 per 100 person years (95% CI: 2.6, 7.5); 63 cases of NG or 26.3 per 100 person years (95% CI: 19.8, 32.8); and 81 cases of CT or 36.3 per 100 person years (95% CI: 28.4, 44.2). We found no association between adequate PrEP adherence and STI incidence (aIRR: 0.97 95% CI: 0.67, 1.40).
CONCLUSIONS


We found that the incidence of STIs was not significantly different between those adherent to PrEP and those non-adherent. Further research is needed to assess how PrEP use may impact STIs over time.",2022,"RESULTS


Of the 381 assessed for CT, NG and syphilis at one or more follow-up visits","['Participants had 48\xa0weeks of follow-up and had STI testing every 12 or 24\xa0weeks', 'Sexually transmitted infections among participants in an HIV PrEP adherence trial']",[],"['PrEP adherence', 'STI incidence (CT, NG, and syphilis) and PrEP adherence', 'adequate PrEP adherence and STI incidence', 'incidence of STIs']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}]",,0.112287,"RESULTS


Of the 381 assessed for CT, NG and syphilis at one or more follow-up visits","[{'ForeName': 'Claire C', 'Initials': 'CC', 'LastName': 'Bristow', 'Affiliation': 'Division of Infectious Diseases and Global Public Health, Department of Medicine, 12220University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Adiba', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'Division of Infectious Diseases and Global Public Health, Department of Medicine, 12220University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Moore', 'Affiliation': 'Department of Psychiatry, 8784University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Dubé', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Katya', 'Initials': 'K', 'LastName': 'Corado', 'Affiliation': '117316Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Chow', 'Affiliation': 'Division of Infectious Diseases and Global Public Health, Department of Medicine, 12220University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ellorin', 'Affiliation': 'Division of Infectious Diseases and Global Public Health, Department of Medicine, 12220University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Blumenthal', 'Affiliation': 'Division of Infectious Diseases and Global Public Health, Department of Medicine, 12220University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Sheldon R', 'Initials': 'SR', 'LastName': 'Morris', 'Affiliation': 'Division of Infectious Diseases and Global Public Health, Department of Medicine, 12220University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of STD & AIDS,['10.1177/09564624211053428']
3204,35239416,Prospective Cardiovascular Surveillance of Immune Checkpoint Inhibitor-Based Combination Therapy in Patients With Advanced Renal Cell Cancer: Data From the Phase III JAVELIN Renal 101 Trial.,"PURPOSE


Both immune checkpoint inhibitors (ICIs) and vascular endothelial growth factor receptor (VEGFR) inhibitors are approved for advanced renal cell carcinoma treatment and can cause cardiovascular events (CVs); thus, combination therapy could lead to major adverse CV events (MACE). Cardiac serum biomarker assessment and imaging, including left ventricular ejection fraction (LVEF) monitoring, can be used to evaluate MACE.
METHODS


To our knowledge, the JAVELIN Renal 101 trial, assessing avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma, is the first randomized study of ICI plus VEGFR inhibitor treatment to include prospective serial cardiac monitoring of LVEF and serum cardiac biomarkers.
RESULTS


MACE (defined as grade ≥ 3 CV AEs) occurred in 31 patients (7.1%) in the combination arm and 17 patients (3.9%) in the sunitinib arm. Patients in the combination arm who had high baseline troponin T values were at higher risk of MACE versus patients with low values (MACE in 6/35  v  7/135, respectively; relative risk, 3.31; 95% CI, 1.19 to 9.22). This association was not observed in patients treated with sunitinib. Other CV baseline risk factors and serum cardiac biomarkers were not significantly predictive for MACE, although a trend toward an association with dyslipidemia was seen in the combination arm. No clinical value of on-treatment routine monitoring of LVEF in relation to MACE was observed. Although LVEF decline was significantly more frequent in the combination arm, most patients recovered, and decline was not associated with other significant cardiac events or symptoms.
CONCLUSION


Patients with high baseline troponin T levels receiving ICI and VEGFR combinations may need to be monitored more closely for MACE. Routine monitoring of LVEF in asymptomatic patients is not recommended.",2022,"Other CV baseline risk factors and serum cardiac biomarkers were not significantly predictive for MACE, although a trend toward an association with dyslipidemia was seen in the combination arm.","['asymptomatic patients', 'Patients With Advanced Renal Cell Cancer', 'patients with advanced renal cell carcinoma']","['immune checkpoint inhibitors (ICIs) and vascular endothelial growth factor receptor (VEGFR) inhibitors', 'avelumab plus axitinib versus sunitinib', 'Immune Checkpoint Inhibitor-Based Combination Therapy', 'ICI plus VEGFR inhibitor']","['LVEF decline', 'CV baseline risk factors and serum cardiac biomarkers', 'high baseline troponin T values']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0291669,"Other CV baseline risk factors and serum cardiac biomarkers were not significantly predictive for MACE, although a trend toward an association with dyslipidemia was seen in the combination arm.","[{'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Javid J', 'Initials': 'JJ', 'LastName': 'Moslehi', 'Affiliation': 'Section of Cardio-Oncology & Immunology, Division of Cardiology, Cardiovascular Research Institute, University of California San Francisco School of Medicine, San Francisco, CA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonaca', 'Affiliation': 'Colorado Prevention Center Clinical Research, Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Schmidinger', 'Affiliation': 'Department of Urology and Comprehensive Cancer Center, Medical University of Vienna, Waehringer Guertel, Vienna, Austria.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Medical Oncology Department, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, DC.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Haanen', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Mariani', 'Affiliation': 'Oncology Research Unit, Pfizer srl, Milano, Italy.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Statistics, Pfizer, Cambridge, MA.'}, {'ForeName': 'Subramanian', 'Initials': 'S', 'LastName': 'Hariharan', 'Affiliation': 'Oncology, Pfizer, New York, NY.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.21.01806']
3205,35239737,A test of affect processing bias in response to affect regulation.,"In this study we merged methods from machine learning and human neuroimaging to test the role of self-induced affect processing states in biasing the affect processing of subsequent image stimuli. To test this relationship we developed a novel paradigm in which (n = 40) healthy adult participants observed affective neural decodings of their real-time functional magnetic resonance image (rtfMRI) responses as feedback to guide explicit regulation of their brain (and corollary affect processing) state towards a positive valence goal state. By this method individual differences in affect regulation ability were controlled. Attaining this brain-affect goal state triggered the presentation of pseudo-randomly selected affectively congruent (positive valence) or incongruent (negative valence) image stimuli drawn from the International Affective Picture Set. Separately, subjects passively viewed randomly triggered positively and negatively valent image stimuli during fMRI acquisition. Multivariate neural decodings of the affect processing induced by these stimuli were modeled using the task trial type (state- versus randomly-triggered) as the fixed-effect of a general linear mixed-effects model. Random effects were modeled subject-wise. We found that self-induction of a positive valence brain state significantly positively biased valence processing of subsequent stimuli. As a manipulation check, we validated affect processing state induction achieved by the image stimuli using independent psychophysiological response measures of hedonic valence and autonomic arousal. We also validated the predictive fidelity of the trained neural decoding models using brain states induced by an out-of-sample set of image stimuli. Beyond its contribution to our understanding of the neural mechanisms that bias affect processing, this work demonstrated the viability of novel experimental paradigms triggered by pre-defined cognitive states. This line of individual differences research potentially provides neuroimaging scientists with a valuable tool for exploring the roles and identities of intrinsic cognitive processing mechanisms that shape our perceptual processing of sensory stimuli.",2022,We found that self-induction of a positive valence brain state significantly positively biased valence processing of subsequent stimuli.,['n = 40) healthy adult participants observed affective neural decodings of their'],['real-time functional magnetic resonance image (rtfMRI) responses'],['hedonic valence and autonomic arousal'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",40.0,0.0199182,We found that self-induction of a positive valence brain state significantly positively biased valence processing of subsequent stimuli.,"[{'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Bush', 'Affiliation': 'Brain Imaging Research Center, Department of Psychiatry, University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States of America.'}, {'ForeName': 'Clinton D', 'Initials': 'CD', 'LastName': 'Kilts', 'Affiliation': 'Brain Imaging Research Center, Department of Psychiatry, University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States of America.'}]",PloS one,['10.1371/journal.pone.0264758']
3206,35239732,"Long-term safety and efficacy of ferric citrate in phosphate-lowering and iron-repletion effects among patients with on hemodialysis: A multicenter, open-label, Phase IV trial.","BACKGROUND


We explored the long-term safety and efficacy of ferric citrate in hemodialysis patients in Taiwan, and further evaluated the iron repletion effect and change of iron parameters by different baseline groups.
METHODS


This was a 12-month, Phase IV, multicenter, open-label study. The initial dose of ferric citrate was administered by patients' clinical condition and further adjusted to maintain serum phosphorus at 3.5-5.5 mg/dL. The primary endpoint was to assess the safety profiles of ferric citrate. The secondary endpoints were to evaluate the efficacy by the time-course changes and the number of subjects who achieved the target range of serum phosphorus.
RESULTS


A total of 202 patients were enrolled. No apparent or unexpected safety concerns were observed. The most common treatment-emergent adverse events were gastrointestinal-related with discolored feces (41.6%). Serum phosphorus was well controlled, with a mean dose of 3.35±1.49 g/day, ranging from 1.5 to 6.0 g/day. Iron parameters were significantly improved. The change from baseline of ferritin and TSAT were 227.17 ng/mL and 7.53%, respectively (p-trend<0.001), and the increase started to slow down after 3-6 months of treatment. In addition, the increase trend was found only in patients with lower baseline level of ferritin (≤500 ng/mL) and TSAT (<30%).
CONCLUSIONS


Ferric citrate is an effective phosphate binder with favorable safety profile in ESRD patients. The iron-repletion by ferric citrate is effective, and the increase is limited in patients with a higher baseline. In addition to controlling hyperphosphatemia, ferric citrate also shows additional benefits in the treatment of renal anemia.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT03256838; 12/04/2017.",2022,"The change from baseline of ferritin and TSAT were 227.17 ng/mL and 7.53%, respectively (p-trend<0.001), and the increase started to slow down after 3-6 months of treatment.","['hemodialysis patients in Taiwan', 'patients with on hemodialysis', '202 patients were enrolled', 'ESRD patients']","['Ferric citrate', 'ferric citrate']","['Serum phosphorus', 'efficacy by the time-course changes and the number of subjects who achieved the target range of serum phosphorus', 'safety profiles of ferric citrate', 'phosphate-lowering and iron-repletion effects', 'ferritin and TSAT']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}]","[{'cui': 'C0060231', 'cui_str': 'ferric citrate'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0060231', 'cui_str': 'ferric citrate'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}]",202.0,0.114682,"The change from baseline of ferritin and TSAT were 227.17 ng/mL and 7.53%, respectively (p-trend<0.001), and the increase started to slow down after 3-6 months of treatment.","[{'ForeName': 'Chien-Te', 'Initials': 'CT', 'LastName': 'Lee', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital and Chang Gung University College of Medicine, Taoyuan City, Taiwan.'}, {'ForeName': 'Chin-Chan', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Keelung Chang-Gung Memorial Hospital, Keelung City, Taiwan.'}, {'ForeName': 'Ming-Ju', 'Initials': 'MJ', 'LastName': 'Wu', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung City, Taiwan.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Chiu', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan.'}, {'ForeName': 'Jyh-Gang', 'Initials': 'JG', 'LastName': 'Leu', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ming-Shiou', 'Initials': 'MS', 'LastName': 'Wu', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yu-Sen', 'Initials': 'YS', 'LastName': 'Peng', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Far-Eastern Memorial Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Mai-Szu', 'Initials': 'MS', 'LastName': 'Wu', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan.'}, {'ForeName': 'Der-Cherng', 'Initials': 'DC', 'LastName': 'Tarng', 'Affiliation': 'Division of Nephrology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}]",PloS one,['10.1371/journal.pone.0264727']
3207,35239723,What is the effectiveness of a personalised video story after an online diabetes risk assessment? A Randomised Controlled Trial.,"BACKGROUND


Online risk assessment tools for type 2 diabetes communicate risk information to motivate individuals to take actions and reduce their risk if needed. The impact of these tools on follow-up behaviours (e.g., General Practitioner (GP) visits, improvement in health behaviours) is unknown. This study examined effectiveness of a personalised video story and text-based message on GP and health professional visitations and health behaviours, of individuals assessed as 'high risk' following completion of the online Australian Type 2 Diabetes Risk Assessment Tool (AUSDRISK).
METHODS


A Randomised Controlled Trial (conducted between October 2018 and April 2019) included 477 participants with a high score (≥12). The control group received a text-based message (TM) and the intervention group received both the text-based message and a personalised video story (TM+VS) encouraging them to take follow-up action. Participants reported follow-up actions (one- and three months), and physical activity (PA), dietary behaviours and body weight (baseline, one and three months). Generalized Linear Mixed Models and chi-squared tests were used to test differences in outcomes between groups over time.
RESULTS


The intervention was not more effective for the TM+VS group compared to the TM only group (p-values>0.05 for all outcomes). More participants in the TM only group (49.8% compared to 40.0% in the VS+TM group) visited either a GP or health professional (p = 0.18). During the 3-month follow-up: 44.9% of all participants visited a GP (36.7%) and/or other health professional (31.0%). Significant improvements were found between baseline and three months, in both groups for weekly physical activity, daily fruit and vegetable intake and weight status.
CONCLUSIONS


Messages provided with online diabetes risk assessment tools to those with high-risk, positively influence GP and health professional visitations and promote short-term improvements in health behaviours that may contribute to an overall reduction in the development of type 2 diabetes.
TRIAL REGISTRATION


Australia New Zealand Clinical Trials Registry; ACTRN12619000809134.",2022,"Significant improvements were found between baseline and three months, in both groups for weekly physical activity, daily fruit and vegetable intake and weight status.
",['October 2018 and April 2019) included 477 participants with a high score (≥12'],"['TM+VS', 'text-based message (TM) and the intervention group received both the text-based message and a personalised video story (TM+VS', 'personalised video story', 'personalised video story and text-based message']","['physical activity (PA), dietary behaviours and body weight', 'weekly physical activity, daily fruit and vegetable intake and weight status']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",477.0,0.095215,"Significant improvements were found between baseline and three months, in both groups for weekly physical activity, daily fruit and vegetable intake and weight status.
","[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Williams', 'Affiliation': 'Central Queensland University, School of Health Medical and Applied Sciences, Physical Activity Research Group, Appleton Institute, Queensland, Australia.'}, {'ForeName': 'Quyen', 'Initials': 'Q', 'LastName': 'To', 'Affiliation': 'Central Queensland University, School of Health Medical and Applied Sciences, Physical Activity Research Group, Appleton Institute, Queensland, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Central Queensland University, School of Health Medical and Applied Sciences, Physical Activity Research Group, Appleton Institute, Queensland, Australia.'}]",PloS one,['10.1371/journal.pone.0264749']
3208,35239707,The efficacy of a task model approach to ADL rehabilitation in stroke apraxia and action disorganisation syndrome: A randomised controlled trial.,"BACKGROUND


Apraxia and action disorganization syndrome (AADS) after stroke can disrupt activities of daily living (ADL). Occupational therapy has been effective in improving ADL performance, however, inclusion of multiple tasks means it is unclear which therapy elements contribute to improvement. We evaluated the efficacy of a task model approach to ADL rehabilitation, comparing training in making a cup of tea with a stepping training control condition.
METHODS


Of the 29 stroke survivors with AADS who participated in this cross-over randomized controlled feasibility trial, 25 were included in analysis [44% females; mean(SD) age = 71.1(7.8) years; years post-stroke = 4.6(3.3)]. Participants attended five 1-hour weekly tea making training sessions in which progress was monitored and feedback given using a computer-based system which implemented a Markov Decision Process (MDP) task model. In a control condition, participants received five 1-hour weekly stepping sessions.
RESULTS


Compared to stepping training, tea making training reduced errors across 4 different tea types. The time taken to make a cup of tea was reduced so the improvement in accuracy was not due to a speed-accuracy trade-off. No improvement linked to tea making training was evident in a complex tea preparation task (making two different cups of tea simultaneously), indicating a lack of generalisation in the training.
CONCLUSIONS


The clearly specified but flexible training protocol, together with information on the distribution of errors, provide pointers for further refinement of task model approaches to ADL rehabilitation. It is recommended that the approach be tested under errorless learning conditions with more impaired patients in future research.
TRIAL REGISTRATION


Retrospectively registered at ClinicalTrials.gov on 5th August 2019 [NCT04044911] https://clinicaltrials.gov/ct2/show/NCT04044911?term=Cogwatch&rank=1.",2022,"No improvement linked to tea making training was evident in a complex tea preparation task (making two different cups of tea simultaneously), indicating a lack of generalisation in the training.
","['stroke apraxia and action disorganisation syndrome', 'Of the 29 stroke survivors with AADS who participated in this cross-over randomized controlled feasibility trial, 25 were included in analysis [44% females; mean(SD) age = 71.1(7.8) years; years post-stroke = 4.6(3.3']","['Occupational therapy', 'tea making training sessions', 'task model approach to ADL rehabilitation', 'stepping training, tea making training']",[],"[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0003635', 'cui_str': 'Apraxia'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",[],25.0,0.0177404,"No improvement linked to tea making training was evident in a complex tea preparation task (making two different cups of tea simultaneously), indicating a lack of generalisation in the training.
","[{'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Howe', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Winnie', 'Initials': 'W', 'LastName': 'Chua', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sumner', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Bogna', 'Initials': 'B', 'LastName': 'Drozdowska', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Laverick', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Bevins', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Jean-Baptiste', 'Affiliation': 'School of Electronic, Electrical and Systems Engineering, College of Engineering and Physical Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Russell', 'Affiliation': 'School of Electronic, Electrical and Systems Engineering, College of Engineering and Physical Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Rotshtein', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Wing', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Birmingham, Birmingham, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0264678']
3209,35239968,Efficacy and Safety of Maintenance Ustekinumab for Ulcerative Colitis Through 3 Years: UNIFI Long-term Extension.,"BACKGROUND AND AIMS


The UNIFI long-term extension (LTE) study reports the efficacy and safety of subcutaneous 90 mg ustekinumab through three years of maintenance therapy.
METHODS


Patients randomized to ustekinumab q12w or q8w at maintenance baseline (N=348) and randomized ustekinumab-treated patients in the LTE (N=284) were evaluated. Symptomatic remission (Mayo stool frequency=0/1, rectal bleeding=0) was assessed. Safety included all LTE patients (N=188 placebo and N=457 ustekinumab).
RESULTS


Among patients randomized to the ustekinumab q12w and q8w groups at maintenance baseline, 54.1% and 56.3% achieved symptomatic remission at week 152. Overall, 20% of patients discontinued ustekinumab, 10% of biologicnaïve and 30% of biologic-exposed patients. Among patients in symptomatic remission at year 3, 94.6% and 98.0% of patients were also corticosteroid free. Corticosteroid-free symptomatic remission rates in the ustekinumab q12w and q8w groups were 51.2% and 55.1% at week 152. Remission rates were higher for biologic-naïve patients than those with a history of biologic failure. Biochemical evidence of response was demonstrated by stable, decreased CRP and fecal calprotectin measurements over 3 years.From weeks 96-156, no deaths, major adverse cardiovascular events, or tuberculosis occurred. Nasopharyngitis, ulcerative colitis and upper respiratory tract infection were most frequently reported. One ustekinumab-treated patient with a history of basal cell carcinoma (BCC) reported 2 BCC. One patient in the q8w ustekinumab group who was receiving concomitant 6-mercaptopurine experienced SAEs of neutropenic sepsis and oral herpes.
CONCLUSION


Efficacy of ustekinumab in patients with ulcerative colitis was confirmed through 3 years. No new safety signals were observed.",2022,"From weeks 96-156, no deaths, major adverse cardiovascular events, or tuberculosis occurred.","['patients with ulcerative colitis', 'Ulcerative Colitis', 'Through 3 Years', 'patients (N=188 placebo and N=457 ustekinumab', 'Patients randomized to ustekinumab q12w or q8w at maintenance baseline (N=348) and randomized ustekinumab-treated patients in the LTE (N=284) were evaluated']","['6-mercaptopurine', 'ustekinumab', 'LTE', 'Maintenance Ustekinumab']","['Symptomatic remission (Mayo stool frequency=0/1, rectal bleeding=0', 'neutropenic sepsis and oral herpes', 'Efficacy and Safety', 'CRP and fecal calprotectin measurements', 'deaths, major adverse cardiovascular events, or tuberculosis occurred', 'Nasopharyngitis, ulcerative colitis and upper respiratory tract infection', 'Remission rates', 'Corticosteroid-free symptomatic remission rates', 'symptomatic remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0877153', 'cui_str': 'Neutropenic sepsis'}, {'cui': 'C0341012', 'cui_str': 'Oral herpes simplex infection'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.100105,"From weeks 96-156, no deaths, major adverse cardiovascular events, or tuberculosis occurred.","[{'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Abreu', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Rowbotham', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milano, Italy.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Miao', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Tikhonov', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA.'}, {'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Tadakazu', 'Initials': 'T', 'LastName': 'Hisamatsu', 'Affiliation': 'Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ellen J', 'Initials': 'EJ', 'LastName': 'Scherl', 'Affiliation': 'New York Presbyterian Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Rupert W', 'Initials': 'RW', 'LastName': 'Leong', 'Affiliation': 'The University of New South Wales and Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ramesh P', 'Initials': 'RP', 'LastName': 'Arasaradnam', 'Affiliation': 'University Hospital Coventry & Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Waqqas', 'Initials': 'W', 'LastName': 'Afif', 'Affiliation': 'Division of Gastroenterology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'University of Lorraine, CHRU-Nancy, Department of Gastroenterology and Nutrition, Genetics, and Environmental Risk Exposure (NGERE), Nancy, France.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Marano', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA.'}]",Journal of Crohn's & colitis,['10.1093/ecco-jcc/jjac030']
3210,35239964,"Erratum. Effects of the SGLT2 Inhibitor Dapagliflozin on Energy Metabolism in Patients With Type 2 Diabetes: A Randomized, Double-Blind Crossover Trial. Diabetes Care 2021;44:1334-1343.",,2022,,['Patients With Type 2 Diabetes'],['SGLT2 Inhibitor Dapagliflozin'],['Energy Metabolism'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0014272', 'cui_str': 'Energy expenditure'}]",,0.545337,,"[{'ForeName': 'Yvo J M Op den', 'Initials': 'YJMOD', 'LastName': 'Kamp', 'Affiliation': ''}, {'ForeName': 'Marlies de', 'Initials': 'M', 'LastName': 'Ligt', 'Affiliation': ''}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Dautzenberg', 'Affiliation': ''}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kornips', 'Affiliation': ''}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Esterline', 'Affiliation': ''}, {'ForeName': 'Matthijs K C', 'Initials': 'MKC', 'LastName': 'Hesselink', 'Affiliation': ''}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Hoeks', 'Affiliation': ''}, {'ForeName': 'Vera B', 'Initials': 'VB', 'LastName': 'Schrauwen-Hinderling', 'Affiliation': ''}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Havekes', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oscarsson', 'Affiliation': ''}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Phielix', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': ''}]",Diabetes care,['10.2337/dc22-er05a']
3211,35239885,"Influence of small-group experiential learning of integrated traditional Chinese and Western medicine on the oral health knowledge, beliefs, and behaviors of elderly patients with diabetes.","OBJECTIVE


This study aimed at the oral health problems of elderly patients with diabetes. A training course of integrated traditional Chinese and Western medicine was constructed, helping patients improve their oral health quality of life.
METHODS


A randomized controlled prospective experimental study was conducted. A total of 190 elderly patients were divided randomly into an observation group and a control group with 95 cases in each. The control group received regular health education, while the observation group was based on the control group to implement the integrated experiential learning of traditional Chinese and Western medicine in small groups. The oral health knowledge, attitude, behavior, and blood glucose control status along with the oral health quality of life of the two groups were compared before the intervention and at 3-month postintervention.
RESULTS


Three months after the intervention, the fasting blood glucose control and the 2-h postprandial blood glucose/glycosylated hemoglobin levels in the observation group were significantly better than in the control group, and the difference was statistically significant (p<0.05). The oral health quality of life in the observation group was significantly better than in the control group, and the difference was statistically significant (p<0.05).
CONCLUSION


The small-group experiential learning model of integrated Chinese and Western medicine can promote the transformation of knowledge-beliefs-behaviors in elderly patients with diabetes, which is conducive to controlling blood sugar levels and improving the quality of oral health.",2022,"The oral health quality of life in the observation group was significantly better than in the control group, and the difference was statistically significant (p<0.05).
","['elderly patients with diabetes', '190 elderly patients']","['small-group experiential learning of integrated traditional Chinese and Western medicine', 'regular health education, while the observation group was based on the control group to implement the integrated experiential learning of traditional Chinese and Western medicine in small groups', 'integrated Chinese and Western medicine']","['oral health knowledge, attitude, behavior, and blood glucose control status', 'oral health quality of life', 'fasting blood glucose control and the 2-h postprandial blood glucose/glycosylated hemoglobin levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517622', 'cui_str': '190'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",190.0,0.010846,"The oral health quality of life in the observation group was significantly better than in the control group, and the difference was statistically significant (p<0.05).
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Affiliated Hospital of Hebei University, Department of Integrated Traditional Chinese and Western Medicine - Baoding, China.'}, {'ForeName': 'De-Xu', 'Initials': 'DX', 'LastName': 'Li', 'Affiliation': 'Affiliated Hospital of Hebei University, Department of Integrated Traditional Chinese and Western Medicine - Baoding, China.'}, {'ForeName': 'Yi-Lin', 'Initials': 'YL', 'LastName': 'Wang', 'Affiliation': 'Shandong University, School of Basic Medicine - Jinan, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Tao', 'Affiliation': 'Affiliated Hospital of Hebei University, Department of Integrated Traditional Chinese and Western Medicine - Baoding, China.'}, {'ForeName': 'Jin-Tao', 'Initials': 'JT', 'LastName': 'Wang', 'Affiliation': 'Affiliated Hospital of Hebei University, Department of Stomatology - Baoding, China.'}, {'ForeName': 'Ya-Min', 'Initials': 'YM', 'LastName': 'Zhao', 'Affiliation': 'Affiliated Hospital of Hebei University, Department of Endocrinology - Baoding, China.'}, {'ForeName': 'Ling-Ling', 'Initials': 'LL', 'LastName': 'Li', 'Affiliation': 'Affiliated Hospital of Hebei University, Department of Tuberculosis - Baoding, China.'}, {'ForeName': 'Yan-Ling', 'Initials': 'YL', 'LastName': 'Li', 'Affiliation': 'Affiliated Hospital of Hebei University, Department of Tuberculosis - Baoding, China.'}]",Revista da Associacao Medica Brasileira (1992),['10.1590/1806-9282.20210833']
3212,35239855,A phase 2 trial of short-course Hyperthermic IntraPeritoneal Chemotherapy (HIPEC) at interval cytoreductive surgery (iCRS) for advanced ovarian cancer.,"OBJECTIVE


to report the final analysis of a phase 2 trial assessing the efficacy and safety of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with advanced epithelial ovarian cancer (EOC).
METHODS


this was an open-label, multicenter, single-arm trial of HIPEC in patients with advanced EOC who underwent interval cytoreductive surgery (iCRS) after neoadjuvant chemotherapy (NACT). HIPEC was performed as a concentration-based regimen of platinum-based chemotherapy for 30 minutes. Primary endpoint was the rate of disease progression occurring at nine months following iCRS plus HIPEC (PD9). Secondary endpoints were postoperative complications, time to start adjuvant chemotherapy, length of hospital and ICU stay, quality of life (QoL) over treatment, and ultimately 2-year progression-free survival (PFS) and overall survival (OS). Analysis was by intention-to-treat with final database lock for survival outcomes on February 23, 2021.
RESULTS


fifteen patients with stage III EOC were enrolled between February 2015 and July 2019, in four centers. The intention to treat PD9 was 6.7%. With a median follow-up of 33 months (IQR, 24.3-46.5), the median PFS was 18.1 months and corresponding 2-year rates of PFS and OS was 33.3% and 93.3%, respectively. Three patients (20%) experienced graded III complications. Median length of hospital and ICU stay was 5 (IQR, 4-6.5) and 1 (IQR, 1-1) days, respectively. Time to restart systemic chemotherapy was 39 (IQR, 35-49.3) days and no significant difference over time in QoL was observed.
CONCLUSIONS


we demonstrate preliminary efficacy and safety of short-course HIPEC in patient with advanced EOC.",2022,"Time to restart systemic chemotherapy was 39 (IQR, 35-49.3) days and no significant difference over time in QoL was observed.
","['patients with advanced EOC who underwent interval cytoreductive surgery (iCRS) after neoadjuvant chemotherapy (NACT', 'patients with advanced epithelial ovarian cancer (EOC', 'fifteen patients with stage III EOC were enrolled between February 2015 and July 2019, in four centers', 'patient with advanced EOC', 'advanced ovarian cancer']","['short-course hyperthermic intraperitoneal chemotherapy (HIPEC', 'short-course Hyperthermic IntraPeritoneal Chemotherapy (HIPEC) at interval cytoreductive surgery (iCRS', 'short-course HIPEC', 'HIPEC', 'platinum-based chemotherapy']","['rate of disease progression', 'median PFS', 'time in QoL', 'postoperative complications, time to start adjuvant chemotherapy, length of hospital and ICU stay, quality of life (QoL) over treatment, and ultimately 2-year progression-free survival (PFS) and overall survival (OS', '2-year rates of PFS and OS', 'Median length of hospital and ICU stay', 'graded III complications', 'efficacy and safety', 'Time to restart systemic chemotherapy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",15.0,0.448698,"Time to restart systemic chemotherapy was 39 (IQR, 35-49.3) days and no significant difference over time in QoL was observed.
","[{'ForeName': 'Thales Paulo', 'Initials': 'TP', 'LastName': 'Batista', 'Affiliation': '- IMIP - Instituto de Medicina Integral Professor Fernando Figueira, Department of Surgery/Oncology - Recife - PE - Brasil.'}, {'ForeName': 'Vandré Cabral Gomes', 'Initials': 'VCG', 'LastName': 'Carneiro', 'Affiliation': '- IMIP - Instituto de Medicina Integral Professor Fernando Figueira, Department of Surgery/Oncology - Recife - PE - Brasil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Tancredi', 'Affiliation': '- IMIP - Instituto de Medicina Integral Professor Fernando Figueira, Department of Clinical Oncology - Recife - PE - Brasil.'}, {'ForeName': 'Levon', 'Initials': 'L', 'LastName': 'Badiglian Filho', 'Affiliation': '- AC Camargo Cancer Center, Department of Gynecology - São Paulo - SP - Brasil.'}, {'ForeName': 'Ronaldo Lúcio Costa', 'Initials': 'RLC', 'LastName': 'Rangel', 'Affiliation': '- IBCC - Instituto Brasileiro de Controle do Câncer, Department of Gynecology - São Paulo - SP - Brasil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Lopes', 'Affiliation': '- IBCC - Instituto Brasileiro de Controle do Câncer, Department of Gynecology - São Paulo - SP - Brasil.'}, {'ForeName': 'Bruno José Queiroz', 'Initials': 'BJQ', 'LastName': 'Sarmento', 'Affiliation': '- IHBDF - Instituto Hospital de Base do Distrito Federal, Serviço de Oncologia Cirúrgica - Brasília - DF - Brasil.'}, {'ForeName': 'Cristiano Souza', 'Initials': 'CS', 'LastName': 'Leão', 'Affiliation': '- IMIP - Instituto de Medicina Integral Professor Fernando Figueira, Departamento de Cirurgia - Recife - PE - Brasil.'}]",Revista do Colegio Brasileiro de Cirurgioes,['10.1590/0100-6991e-20223135']
3213,35239819,Medication reconciliation role and value in Alzheimer's disease treatment.,"BACKGROUND


With the continuous increase of Alzheimer's disease (AD), it is also imminent to treat patients with AD for medication reconciliation.
OBJECTIVE


To explore the role and value of medication reconciliation in AD treatment.
METHODS


100 patients over 65 years of age diagnosed with AD were randomly separated into two groups: conventional treatment and medication reforming. The list of medical orders of all subjects was obtained within 24 hours after admission with Beers criteria, STOPP/START criteria, and Chinese Pharmacopoeia used as the MED intervention criteria. Medication reconciliation was performed at 2 weeks, 1 month, and 2 months after hospital admission. The number of medications prescribed, the quantity of the medication, medication error rate, therapeutic effect, adverse drug reactions, and satisfaction levels of family members and main caregivers were compared between the two groups.
RESULTS


After the intervention, the types and amount of medication in the MED group were less compared to the CON group along with a reduced medication deviation rate. The Mini-mental state examination (MMSE) score and the proportion of well-nourished patients in the MED group were higher than those in the CON group. It was also observed that the physical self-care ability score and the proportion of patients with abnormal swallowing were lower when in comparison with the CON group. The incidence of adverse drug reactions in the MED group was lower than that in the CON group. However, the satisfaction rate was higher than that in the CON group.
CONCLUSION


Medication reconciliation can reduce the medication deviation in AD patients.",2022,The incidence of adverse drug reactions in the MED group was lower than that in the CON group.,"['patients with AD for medication reconciliation', 'AD patients', '100 patients over 65 years of age diagnosed with AD', ""Alzheimer's disease treatment""]","['CON', 'conventional treatment and medication reforming']","['satisfaction rate', 'medication deviation', 'Mini-mental state examination (MMSE) score', 'number of medications prescribed, the quantity of the medication, medication error rate, therapeutic effect, adverse drug reactions, and satisfaction levels of family members and main caregivers', 'physical self-care ability score and the proportion of patients with abnormal swallowing', 'adverse drug reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C2317067', 'cui_str': 'Medication Reconciliation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0562734', 'cui_str': 'Ability to perform personal care activity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}]",100.0,0.167833,The incidence of adverse drug reactions in the MED group was lower than that in the CON group.,"[{'ForeName': 'Xueqian', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'The Second Hospital of Jinhua, Department of Pharmacy, Zhejiang Province, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'The Second Hospital of Jinhua, Department of Five Wards of Geriatrics, Zhejiang Province, China.'}, {'ForeName': 'Wenliang', 'Initials': 'W', 'LastName': 'Shao', 'Affiliation': 'The Second Hospital of Jinhua, Department of Pharmacy, Zhejiang Province, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'The Second Hospital of Jinhua, Department of Pharmacy, Zhejiang Province, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'The Second Hospital of Jinhua, Department of Five Wards of Geriatrics, Zhejiang Province, China.'}]",Arquivos de neuro-psiquiatria,['10.1590/0004-282X-ANP-2021-0147']
3214,35240075,"Venetoclax consolidation after fixed-duration venetoclax plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (HOVON 139/GiVe): primary endpoint analysis of a multicentre, open-label, randomised, parallel-group, phase 2 trial.","BACKGROUND


Fixed-duration 12 cycles of venetoclax plus obinutuzumab is established as first-line treatment for patients with chronic lymphocytic leukaemia. We aimed to determine the activity and safety of 12 cycles of venetoclax consolidation after fixed-duration venetoclax plus obinutuzumab for previously untreated patients with chronic lymphocytic leukaemia who were unfit for fludarabine-based treatment, and whether this could be guided by minimal residual disease status.
METHODS


We conducted an open-label, randomised, parallel-group, phase 2 trial (HOVON 139/GiVe) at 25 hospitals in the Netherlands. Eligible patients were aged 18 years or older with previously untreated chronic lymphocytic leukaemia, had an ECOG performance status of 0-2, and were unfit for fludarabine-based treatment. All patients received two debulking cycles of intravenous obinutuzumab (100 mg on day 1, 900 mg on day 2, and 1000 mg on days 8, 15, and day 1 of cycle two), followed by fixed-duration venetoclax plus obinutuzumab for 12 cycles (six cycles of intravenous obinutuzumab 1000 mg on day 1 and 12 during 28-day cycles of oral venetoclax, starting with a 5-week ramp-up and then 400 mg once daily until completion of cycle 12). Patients were then randomly assigned (1:1) by minimal residual disease status in peripheral blood, to receive either 12 cycles of venetoclax consolidation irrespective of minimal residual disease or venetoclax consolidation only if minimal residual disease was detected at randomisation. The primary endpoint was undetectable minimal residual disease in bone marrow and no progressive disease 3 months after end of consolidation treatment (or corresponding timepoint) by intention-to-treat. Safety was assessed in all patients who received at least one dose of any study drug. This is the primary endpoint analysis of this trial, which is ongoing and is registered with EudraCT (2015-004985-27).
FINDINGS


Between Oct 28, 2016, and May 31, 2018, 70 patients were enrolled, of whom 67 (47 [70%] men and 20 [30%] women) received fixed-duration treatment and 62 were randomly assigned to receive 12 cycles of venetoclax consolidation (n=32) or minimal residual disease-guided venetoclax consolidation (n=30; one of whom was minimal residual disease positive at randomisation). Median follow-up was 35·2 months (IQR 31·5-41·3). 16 (50% [95% CI 32-68]) of 32 patients in the consolidation group and 16 (53% [34-72]) of 30 in the minimal residual disease-guided consolidation group met the primary endpoint of undetectable minimal residual disease in bone marrow and no progressive disease. 22 (69%) of 32 patients in the venetoclax consolidation group and 11 (37%) of 30 in the minimal residual disease-guided consolidation group had any adverse event (grade 2-4; mainly infections). The most common grade 3 or worse adverse events were infection (two [6%] of 32 patients in the consolidation group and one [3%] of 30 in the minimal residual disease-guided consolidation group) and neutropenia (two [6%] and two [7%]). There were no treatment-related deaths.
INTERPRETATION


Consolidation with venetoclax 12-cycle treatment increases the duration of known side-effects and does not prevent the loss of minimal residual disease response and subsequent risk of disease relapse.
FUNDING


F Hoffmann-La Roche.",2022,"There were no treatment-related deaths.
","['previously untreated chronic lymphocytic leukaemia (HOVON 139/GiVe', 'patients with chronic lymphocytic leukaemia', '25 hospitals in the Netherlands', 'of whom 67 (47 [70%] men and 20 [30%] women) received', '22', 'previously untreated patients with chronic lymphocytic leukaemia who were unfit for', 'Eligible patients were aged 18 years or older with previously untreated chronic lymphocytic leukaemia, had an ECOG performance status of 0-2, and were unfit for fludarabine-based treatment', '16', 'Between Oct 28, 2016, and May 31, 2018', '2015-004985-27', '70 patients were enrolled']","['Venetoclax consolidation after fixed-duration venetoclax plus obinutuzumab', 'venetoclax plus obinutuzumab', 'venetoclax consolidation', 'fixed-duration treatment', 'venetoclax consolidation (n=32) or minimal residual disease-guided venetoclax consolidation', 'venetoclax consolidation after fixed-duration venetoclax plus obinutuzumab', 'intravenous obinutuzumab', 'EudraCT', 'fludarabine-based treatment']","['Safety', 'undetectable minimal residual disease in bone marrow and no progressive disease', 'activity and safety', 'adverse event', 'duration of known side-effects', 'neutropenia']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]","[{'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",70.0,0.212239,"There were no treatment-related deaths.
","[{'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Kersting', 'Affiliation': 'Department of Hematology, HAGA Teaching Hospital, The Hague, Netherlands. Electronic address: s.kersting@hagaziekenhuis.nl.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dubois', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Lymphoma and Myeloma Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Nasserinejad', 'Affiliation': 'Department of Hematology, HOVON Data Center, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Johan A', 'Initials': 'JA', 'LastName': 'Dobber', 'Affiliation': 'Department of Laboratory Special Hematology, Amsterdam University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Mellink', 'Affiliation': 'Department of Human Genetics, Section Cytogenetics, Amsterdam University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Anne-Marie F', 'Initials': 'AF', 'LastName': 'van der Kevie-Kersemaekers', 'Affiliation': 'Department of Human Genetics, Section Cytogenetics, Amsterdam University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Ludo M', 'Initials': 'LM', 'LastName': 'Evers', 'Affiliation': 'Department of Laboratory Special Hematology, Amsterdam University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Fransien', 'Initials': 'F', 'LastName': 'de Boer', 'Affiliation': 'Department of Internal Medicine, Ikazia Hospital, Rotterdam, Netherlands.'}, {'ForeName': 'Harry R', 'Initials': 'HR', 'LastName': 'Koene', 'Affiliation': 'Department of Hematology, Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Schreurs', 'Affiliation': 'Department of Internal Medicine, Martini Hospital, Groningen, Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'van der Klift', 'Affiliation': 'Department of Internal Medicine, Amphia Hospital, Breda, Netherlands.'}, {'ForeName': 'Gerjo A', 'Initials': 'GA', 'LastName': 'Velders', 'Affiliation': 'Department of Internal Medicine, Gelderland Valley Hospital, Ede, Netherlands.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'van der Spek', 'Affiliation': 'Department of Internal Medicine, Rijnstate Hospital, Arnhem, Netherlands.'}, {'ForeName': 'Hanneke M', 'Initials': 'HM', 'LastName': 'van der Straaten', 'Affiliation': 'Department of Internal Medicine, St Jansdal Hospital, Harderwijk, Netherlands.'}, {'ForeName': 'Mels', 'Initials': 'M', 'LastName': 'Hoogendoorn', 'Affiliation': 'Department of Internal Medicine, Medical Center Leeuwarden, Leeuwarden, Netherlands.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'van Gelder', 'Affiliation': 'Department of Hematology, MUMC, Maastricht, Netherlands.'}, {'ForeName': 'Eduardus F M', 'Initials': 'EFM', 'LastName': 'Posthuma', 'Affiliation': 'Department of Internal Medicine, RDGG, Delft, Netherlands.'}, {'ForeName': 'Hein P J', 'Initials': 'HPJ', 'LastName': 'Visser', 'Affiliation': 'Department of Internal Medicine, Northwest Clinics, Alkmaar, Netherlands.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Houtenbos', 'Affiliation': 'Department of Internal Medicine, Spaarne Gasthuis, Hoofddorp, Netherlands.'}, {'ForeName': 'Cecile A M', 'Initials': 'CAM', 'LastName': 'Idink', 'Affiliation': 'Department of Internal Medicine, ZorgSaam hospital, Terneuzen, Netherlands.'}, {'ForeName': 'Djamila E', 'Initials': 'DE', 'LastName': 'Issa', 'Affiliation': ""Department of Internal Medicine, Jeroen Bosch hospital, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Ellen C', 'Initials': 'EC', 'LastName': 'Dompeling', 'Affiliation': 'Department of Hematology, Isala Hospital, Zwolle, Netherlands.'}, {'ForeName': 'Henk C T', 'Initials': 'HCT', 'LastName': 'van Zaanen', 'Affiliation': 'Department of Internal Medicine, St Franciscus Hospital, Rotterdam, Netherlands.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Veelken', 'Affiliation': 'Department of Hematology, LUMC, Leiden, Netherlands.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Levenga', 'Affiliation': 'Department of Internal Medicine, Groene Harthospital, Gouda, Netherlands.'}, {'ForeName': 'Lidwine W', 'Initials': 'LW', 'LastName': 'Tick', 'Affiliation': 'Department of Internal Medicine, Maxima MC, Eindhoven, Netherlands.'}, {'ForeName': 'Wim E', 'Initials': 'WE', 'LastName': 'Terpstra', 'Affiliation': 'Department of Internal Medicine, OLVG, Amsterdam, Netherlands.'}, {'ForeName': 'Sanne H', 'Initials': 'SH', 'LastName': 'Tonino', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Lymphoma and Myeloma Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Boyer', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Mobasher', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Arnon P', 'Initials': 'AP', 'LastName': 'Kater', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Lymphoma and Myeloma Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Haematology,['10.1016/S2352-3026(22)00034-5']
3215,35240074,"Avatrombopag for chemotherapy-induced thrombocytopenia in patients with non-haematological malignancies: an international, randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


Chemotherapy-induced thrombocytopenia is common and causes chemotherapy dose reductions or treatment delays, bleeding, and suboptimal oncological outcomes. We aimed to evaluate avatrombopag, a thrombopoietin receptor agonist that increases platelet counts, in patients with non-haematological cancer and platelet counts lower than 50 ×10 9  cells per L.
METHODS


In this randomised, double-blind, placebo-controlled, phase 3 study, patients aged 18 years or older at 71 hospitals or cancer treatment centres in China, Hungary, Poland, Russia, Serbia, Ukraine, and the USA and with ovarian, bladder, or lung cancer receiving chemotherapy who had severe thrombocytopenia were randomly assigned (2:1) to oral avatrombopag 60 mg or oral placebo once daily given 5 days before and after chemotherapy, with randomisation stratified by number of chemotherapy drugs used. Patients, investigators, and data collectors were masked to group allocation. Eligibility required two previous lines of chemotherapy or fewer, an ECOG performance status of 2 or less, and no previous history of chemotherapy-induced thrombocytopenia. The composite primary endpoint was the proportion of responders not requiring platelet transfusion or either a 15% or more chemotherapy dose reduction or a 4-day or more chemotherapy delay due to thrombocytopenia following study treatment until the start of the subsequent cycle. Analyses were done on the intention-to-treat and per protocol populations. Safety was analysed in all patients who received at least one dose of avatrombopag. The trial is registered with ClinicalTrials.gov, NCT03471078, and has been completed.
FINDINGS


Between Oct 12, 2018, and June 28, 2020, 122 patients were enrolled and randomly assigned to receive avatrombopag (n=82) or placebo (n=40). Median follow-up was 31 days (IQR 22-61). Similar proportions of patients reached the primary endpoint in the avatrombopag and placebo groups (intention-to-treat: 57 [70%, 95% CI 58-79] of 82 vs 29 [73%, 95% CI 56-85] of 40; difference -3·0% (95% CI -21·6 to 15·6); p=0·72; per protocol: 51 [85%, 95% CI 73-93] of 60 vs 27 [84%, 95% CI 67-95] of 32; 0·6% (95% CI -20·8 to 22·1); p=0·96). 15 (18%) of 82 patients had serious adverse events in the avatrombopag group and eight (20%) of 40 in the placebo group, of which thrombocytopenia was most common (4 [5%] of 82 and 4 [10%] of 40 patients). Common grade 3-4 treatment-emergent adverse events were neutropenia (22 [27%] of 82 and 16 [40%] of 40 patients), leukopenia (19 [23%] of 82 and 5 [13%] of 40), anaemia (16 [20%] of 82 and 9 [23%] of 40), and thrombocytopenia (16 [20%] of 82 and 14 [35%] of 40). Most adverse events were considered unrelated to study drug. No treatment-related deaths were reported.
INTERPRETATION


In this population of patients with non-haematological malignancies who are relatively chemotherapy naive, chemotherapy-induced thrombocytopenia treatment outcomes were similar between the avatrombopag and placebo groups. Given its safety and ability to augment platelet counts in patients with chemotherapy-induced thrombocytopenia, evaluation of avatrombopag in populations with more persistent chemotherapy-induced thrombocytopenia is warranted.
FUNDING


Dova Pharmaceuticals, a Sobi company.",2022,"No treatment-related deaths were reported.
","['patients with non-haematological cancer and platelet counts lower than 50\u2008×10 9  cells per L', 'patients aged 18 years or older at 71 hospitals or cancer treatment centres in China, Hungary, Poland, Russia, Serbia, Ukraine, and the USA and with ovarian, bladder, or lung cancer receiving chemotherapy who had severe thrombocytopenia', 'patients with non-haematological malignancies', 'Between Oct 12, 2018, and June 28, 2020, 122 patients', 'patients with chemotherapy-induced thrombocytopenia, evaluation of avatrombopag in populations with more persistent chemotherapy-induced thrombocytopenia']","['Avatrombopag for chemotherapy-induced thrombocytopenia', 'avatrombopag', 'placebo', 'oral avatrombopag 60 mg or oral placebo']","['Safety', 'serious adverse events', 'anaemia', 'thrombocytopenia', 'leukopenia', 'neutropenia', 'proportion of responders not requiring platelet transfusion or either a 15% or more chemotherapy dose reduction or a 4-day or more chemotherapy delay due to thrombocytopenia', 'thrombocytopenia treatment outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0036708', 'cui_str': 'Republic of Serbia'}, {'cui': 'C0041580', 'cui_str': 'Ukraine'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C3886460', 'cui_str': 'avatrombopag'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]","[{'cui': 'C3886460', 'cui_str': 'avatrombopag'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0086818', 'cui_str': 'Platelet transfusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",122.0,0.675671,"No treatment-related deaths were reported.
","[{'ForeName': 'Hanny', 'Initials': 'H', 'LastName': 'Al-Samkari', 'Affiliation': 'Division of Hematology Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: hal-samkari@mgh.harvard.edu.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Kolb-Sielecki', 'Affiliation': 'Oncological Department, University of Warmia and Mazury in Olsztyn, Olsztyn, Poland.'}, {'ForeName': 'Sufiia Z', 'Initials': 'SZ', 'LastName': 'Safina', 'Affiliation': 'Medical Oncology, Tatarstan Regional Cancer Centre, Kazan, Russia.'}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'Dova Pharmaceuticals (a Sobi company), Durham, NC, USA.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Jamieson', 'Affiliation': 'Dova Pharmaceuticals (a Sobi company), Durham, NC, USA.'}]",The Lancet. Haematology,['10.1016/S2352-3026(22)00001-1']
3216,35240053,"Elective upper-neck versus whole-neck irradiation of the uninvolved neck in patients with nasopharyngeal carcinoma: an open-label, non-inferiority, multicentre, randomised phase 3 trial.","BACKGROUND


The aim of this trial was to address whether elective ipsilateral upper-neck irradiation (UNI) sparing the uninvolved lower neck provides similar regional relapse-free survival compared with standard whole-neck irradiation (WNI) in patients with nasopharyngeal carcinoma.
METHODS


This open-label, non-inferiority, randomised, controlled, phase 3 trial was done at three Chinese medical centres. Patients aged 18-65 years with untreated, non-keratinising, non-distant metastatic (M0) nasopharyngeal carcinoma; with N0-N1 disease (according to International Union Against Cancer-American Joint Committee on Cancer TNM classification, seventh edition); and a Karnofsky performance status score of 70 or higher were randomly assigned (1:1) to receive elective UNI or WNI of the uninvolved neck. Total radiation doses of 70 Gy (for the primary tumour volume and the enlarged retropharyngeal nodes), 66-70 Gy (for the involved cervical lymph nodes), 60-62 Gy (for the high-risk target volume), and 54-56 Gy (for the low-risk target volume) were administered in 30-33 fractions, five fractions per week. Patients with stage II-IVA disease were recommended to receive combined intravenous cisplatin-based chemotherapy (either induction chemotherapy followed by concurrent chemoradiotherapy or concurrent chemoradiotherapy alone). Randomisation was done centrally by the Clinical Trials Centre of Sun Yat-sen University Cancer Centre by means of a computer-generated random number code with a block size of four. Patients were stratified according to treatment centre and nodal status. Investigators and patients were not masked to treatment allocation. The primary endpoint was regional relapse-free survival in the intention-to-treat population. Non-inferiority was indicated if the upper limit of the 95% CI of the difference in 3-year regional relapse-free survival between the UNI and WNI groups was within 8%. Adverse events were analysed in the safety population (defined as all patients who commenced the randomly assigned treatment). This study is registered with ClinicalTrials.gov, NCT02642107, and is closed.
FINDINGS


Between Jan 22, 2016, and May 23, 2018, 446 patients from 469 screened were randomly assigned to receive UNI (n=224) or WNI (n=222). Median follow-up was 53 months (IQR 46-59). 3-year regional relapse-free survival was similar in the UNI and WNI groups (97·7% [95% CI 95·7-99·7] in the UNI group vs 96·3% [93·8-98·8] in the WNI group; difference -1·4% [95% CI -4·6 to 1·8]; p non-inferiority <0·0001). Although acute radiation-related toxic effects were similar between the groups, the incidence of late toxicity was lower in the UNI group than in the WNI group, including any-grade hypothyroidism (66 [30%] of 222 patients vs 87 [39%] of 221), skin toxicity (32 [14%] vs 55 [25%]), dysphagia (38 [17%] vs 71 [32%]), and neck tissue damage (50 [23%] vs 88 [40%]). No patients died during treatment. After treatment, one patient in the WNI group died from a non-cancer-related cause (dermatomyositis).
INTERPRETATION


Elective UNI of the uninvolved neck provides similar regional control and results in less radiation toxicity compared with standard WNI in patients with N0-N1 nasopharyngeal carcinoma.
FUNDING


Sun Yat-sen University Clinical Research 5010 Program, the Natural Science Foundation of Guangdong Province, and the Overseas Expertise Introduction Project for Discipline Innovation.
TRANSLATION


For the Chinese translation of the abstract see Supplementary Materials section.",2022,3-year regional relapse-free survival was similar in the UNI and WNI groups (97·7%,"['Between Jan 22, 2016, and May 23, 2018, 446 patients from 469 screened were randomly assigned to receive UNI (n=224) or WNI (n=222', 'Patients with stage II-IVA disease', 'Patients aged 18-65 years with untreated, non-keratinising, non-distant metastatic (M0) nasopharyngeal carcinoma; with N0-N1 disease (according to International Union Against Cancer-American Joint Committee on Cancer TNM classification, seventh edition); and a Karnofsky performance status score of 70 or higher were randomly assigned (1:1) to receive elective UNI or WNI of the uninvolved neck', 'patients with N0-N1 nasopharyngeal carcinoma', 'patients with nasopharyngeal carcinoma']","['standard WNI', 'standard whole-neck irradiation (WNI', 'Elective upper-neck versus whole-neck irradiation of the uninvolved neck', 'combined intravenous cisplatin-based chemotherapy (either induction chemotherapy followed by concurrent chemoradiotherapy or concurrent chemoradiotherapy alone', 'elective ipsilateral upper-neck irradiation (UNI']","['radiation toxicity', 'incidence of late toxicity', 'toxic effects', 'dysphagia', 'neck tissue damage', 'skin toxicity', 'Adverse events', 'regional relapse-free survival', 'grade hypothyroidism', '3-year regional relapse-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0441914', 'cui_str': 'UICC'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0809869', 'cui_str': 'TNM category'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C4545792', 'cui_str': 'KPS (Karnofsky Performance Status) score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205429', 'cui_str': 'Uninvolved'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205429', 'cui_str': 'Uninvolved'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}]","[{'cui': 'C1510432', 'cui_str': 'Radiation sickness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.195239,3-year regional relapse-free survival was similar in the UNI and WNI groups (97·7%,"[{'ForeName': 'Ling-Long', 'Initials': 'LL', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, the State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Cheng-Long', 'Initials': 'CL', 'LastName': 'Huang', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, the State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiation Oncology, First People's Hospital of Foshan, Foshan, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiation Oncology, Affiliated Hospital of Guilin Medical University, Guilin, China.'}, {'ForeName': 'Yi-Shan', 'Initials': 'YS', 'LastName': 'Wu', 'Affiliation': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, the State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Shao Hui', 'Initials': 'SH', 'LastName': 'Huang', 'Affiliation': 'Department of Radiation Oncology, The Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Mao', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, the State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Centre, Sun Yat-sen University Cancer Center, the State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Ji-Bin', 'Initials': 'JB', 'LastName': 'Li', 'Affiliation': 'Clinical Trials Centre, Sun Yat-sen University Cancer Center, the State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Shao-Qiang', 'Initials': 'SQ', 'LastName': 'Liang', 'Affiliation': ""Department of Radiation Oncology, First People's Hospital of Foshan, Foshan, China.""}, {'ForeName': 'Guan-Jie', 'Initials': 'GJ', 'LastName': 'Qin', 'Affiliation': 'Department of Radiation Oncology, Affiliated Hospital of Guilin Medical University, Guilin, China.'}, {'ForeName': 'Wei-Han', 'Initials': 'WH', 'LastName': 'Hu', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, the State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, the State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Fang-Yun', 'Initials': 'FY', 'LastName': 'Xie', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, the State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, the State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Guan-Qun', 'Initials': 'GQ', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, the State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, Sun Yat-sen University Cancer Center, the State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China. Electronic address: majun2@mail.sysu.edu.cn.'}]",The Lancet. Oncology,['10.1016/S1470-2045(22)00058-4']
3217,35240044,"Safety and efficacy of aspirin, unfractionated heparin, both, or neither during endovascular stroke treatment (MR CLEAN-MED): an open-label, multicentre, randomised controlled trial.","BACKGROUND


Aspirin and unfractionated heparin are often used during endovascular stroke treatment to improve reperfusion and outcomes. However, the effects and risks of anti-thrombotics for this indication are unknown. We therefore aimed to assess the safety and efficacy of intravenous aspirin, unfractionated heparin, both, or neither started during endovascular treatment in patients with ischaemic stroke.
METHODS


We did an open-label, multicentre, randomised controlled trial with a 2 × 3 factorial design in 15 centres in the Netherlands. We enrolled adult patients (ie, ≥18 years) with ischaemic stroke due to an intracranial large-vessel occlusion in the anterior circulation in whom endovascular treatment could be initiated within 6 h of symptom onset. Eligible patients had a score of 2 or more on the National Institutes of Health Stroke Scale, and a CT or MRI ruling out intracranial haemorrhage. Randomisation was done using a web-based procedure with permuted blocks and stratified by centre. Patients were randomly assigned (1:1) to receive either periprocedural intravenous aspirin (300 mg bolus) or no aspirin, and randomly assigned (1:1:1) to receive moderate-dose unfractionated heparin (5000 IU bolus followed by 1250 IU/h for 6 h), low-dose unfractionated heparin (5000 IU bolus followed by 500 IU/h for 6 h), or no unfractionated heparin. The primary outcome was the score on the modified Rankin Scale at 90 days. Symptomatic intracranial haemorrhage was the main safety outcome. Analyses were based on intention to treat, and treatment effects were expressed as odds ratios (ORs) or common ORs, with adjustment for baseline prognostic factors. This trial is registered with the International Standard Randomised Controlled Trial Number, ISRCTN76741621.
FINDINGS


Between Jan 22, 2018, and Jan 27, 2021, we randomly assigned 663 patients; of whom, 628 (95%) provided deferred consent or died before consent could be asked and were included in the modified intention-to-treat population. On Feb 4, 2021, after unblinding and analysis of the data, the trial steering committee permanently stopped patient recruitment and the trial was stopped for safety concerns. The risk of symptomatic intracranial haemorrhage was higher in patients allocated to receive aspirin than in those not receiving aspirin (43 [14%] of 310 vs 23 [7%] of 318; adjusted OR 1·95 [95% CI 1·13-3·35]) as well as in patients allocated to receive unfractionated heparin than in those not receiving unfractionated heparin (44 [13%] of 332 vs 22 [7%] of 296; 1·98 [1·14-3·46]). Both aspirin (adjusted common OR 0·91 [95% CI 0·69-1·21]) and unfractionated heparin (0·81 [0·61-1·08]) led to a non-significant shift towards worse modified Rankin Scale scores.
INTERPRETATION


Periprocedural intravenous aspirin and unfractionated heparin during endovascular stroke treatment are both associated with an increased risk of symptomatic intracranial haemorrhage without evidence for a beneficial effect on functional outcome.
FUNDING


The Collaboration for New Treatments of Acute Stroke consortium, the Brain Foundation Netherlands, the Ministry of Economic Affairs, Stryker, Medtronic, Cerenovus, and the Dutch Heart Foundation.",2022,The risk of symptomatic intracranial haemorrhage was higher in patients allocated to receive aspirin than in those not receiving aspirin (43 [14%] of 310 vs 23 [7%] of 318; adjusted OR 1·95 [95% CI 1·13-3·35]) as well as in patients allocated to receive unfractionated heparin than in those not receiving unfractionated heparin (44 [13%] of 332 vs 22 [7%] of 296; 1·98 [1·14-3·46]).,"['Eligible patients had a score of 2 or more on the National Institutes of Health Stroke Scale, and a CT or MRI ruling out intracranial haemorrhage', 'patients with ischaemic stroke', 'enrolled adult patients (ie, ≥18 years) with ischaemic stroke due to an intracranial large-vessel occlusion in the anterior circulation in whom endovascular treatment could be initiated within 6 h of symptom onset', 'Between Jan 22, 2018, and Jan 27, 2021, we randomly assigned 663 patients; of whom, 628 (95%) provided deferred consent or died before consent could be asked and were included in the modified intention-to-treat population', '15 centres in the Netherlands']","['unfractionated heparin (0·81', 'aspirin and unfractionated heparin', 'moderate-dose unfractionated heparin', 'aspirin', 'low-dose unfractionated heparin', 'aspirin, unfractionated heparin', 'aspirin, unfractionated heparin, both, or neither during endovascular stroke treatment (MR CLEAN-MED', 'Aspirin and unfractionated heparin', 'unfractionated heparin', 'periprocedural intravenous aspirin (300 mg bolus) or no aspirin']","['Symptomatic intracranial haemorrhage', 'safety and efficacy', 'risk of symptomatic intracranial haemorrhage', 'score on the modified Rankin Scale', 'Safety and efficacy', 'modified Rankin Scale scores']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1454756', 'cui_str': 'N-acetyl-S-(alpha-methyl-4-(2-methylpropyl)benzeneacetyl)cysteine 4-(nitrooxy)butyl ester'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",663.0,0.433347,The risk of symptomatic intracranial haemorrhage was higher in patients allocated to receive aspirin than in those not receiving aspirin (43 [14%] of 310 vs 23 [7%] of 318; adjusted OR 1·95 [95% CI 1·13-3·35]) as well as in patients allocated to receive unfractionated heparin than in those not receiving unfractionated heparin (44 [13%] of 332 vs 22 [7%] of 296; 1·98 [1·14-3·46]).,"[{'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'van der Steen', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands; Department of Radiology and Nuclear Medicine, Erasmus MC University Medical Center, Rotterdam, Netherlands. Electronic address: w.vandersteen@erasmusmc.nl.'}, {'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'van de Graaf', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands; Department of Radiology and Nuclear Medicine, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Chalos', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands; Department of Radiology and Nuclear Medicine, Erasmus MC University Medical Center, Rotterdam, Netherlands; Department of Public Health, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'Department of Public Health, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Pieter Jan', 'Initials': 'PJ', 'LastName': 'van Doormaal', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Emmer', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'de Ridder', 'Affiliation': 'Department of Neurology, Maastricht University Medical Centre, Cardiovascular Research Institute Maastricht, Maastricht, Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'van Zwam', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Cardiovascular Research Institute Maastricht, Maastricht, Netherlands.'}, {'ForeName': 'H Bart', 'Initials': 'HB', 'LastName': 'van der Worp', 'Affiliation': 'Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'van der Schaaf', 'Affiliation': 'Department of Radiology, Brain Center, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Rob A R', 'Initials': 'RAR', 'LastName': 'Gons', 'Affiliation': 'Department of Neurology, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Lonneke S F', 'Initials': 'LSF', 'LastName': 'Yo', 'Affiliation': 'Department of Radiology, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Jelis', 'Initials': 'J', 'LastName': 'Boiten', 'Affiliation': 'Department of Neurology, Haaglanden Medical Centre, The Hague, Netherlands.'}, {'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'van den Wijngaard', 'Affiliation': 'Department of Neurology, Haaglanden Medical Centre, The Hague, Netherlands; Department of Radiology, Haaglanden Medical Centre, The Hague, Netherlands.'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Hofmeijer', 'Affiliation': 'Department of Neurology, Rijnstate Hospital, Arnhem, Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Martens', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Rijnstate Hospital, Arnhem, Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Schonewille', 'Affiliation': 'Department of Neurology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Jan Albert', 'Initials': 'JA', 'LastName': 'Vos', 'Affiliation': 'Department of Radiology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Anil Man', 'Initials': 'AM', 'LastName': 'Tuladhar', 'Affiliation': 'Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Karlijn F', 'Initials': 'KF', 'LastName': 'de Laat', 'Affiliation': 'Department of Neurology, HagaZiekenhuis, The Hague, Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'van Hasselt', 'Affiliation': 'Department of Radiology, Isala, Zwolle, Netherlands.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Remmers', 'Affiliation': 'Department of Neurology, Amphia Hospital, Breda, Netherlands.'}, {'ForeName': 'Douwe', 'Initials': 'D', 'LastName': 'Vos', 'Affiliation': 'Department of Radiology, Amphia Hospital, Breda, Netherlands.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Rozeman', 'Affiliation': 'Department of Neurology, Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Elgersma', 'Affiliation': 'Department of Radiology, Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Uyttenboogaart', 'Affiliation': 'Department of Neurology, University Medical Center Groningen, Groningen, Netherlands; Department of Radiology, Medical Imaging Center, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Reinoud P H', 'Initials': 'RPH', 'LastName': 'Bokkers', 'Affiliation': 'Department of Radiology, Medical Imaging Center, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'van Tuijl', 'Affiliation': 'Department of Neurology, Elisabeth-TweeSteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Issam', 'Initials': 'I', 'LastName': 'Boukrab', 'Affiliation': 'Department of Radiology, Elisabeth-TweeSteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'van den Berg', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Ludo F M', 'Initials': 'LFM', 'LastName': 'Beenen', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Roosendaal', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Alida Annechien', 'Initials': 'AA', 'LastName': 'Postma', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Cardiovascular Research Institute Maastricht, Maastricht, Netherlands.'}, {'ForeName': 'Menno', 'Initials': 'M', 'LastName': 'Krietemeijer', 'Affiliation': 'Department of Radiology, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Lycklama', 'Affiliation': 'Department of Radiology, Haaglanden Medical Centre, The Hague, Netherlands.'}, {'ForeName': 'Frederick J A', 'Initials': 'FJA', 'LastName': 'Meijer', 'Affiliation': 'Department of Medical Imaging, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Hammer', 'Affiliation': 'Department of Radiology, HagaZiekenhuis, The Hague, Netherlands.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'van der Hoorn', 'Affiliation': 'Department of Radiology, Medical Imaging Center, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Yoo', 'Affiliation': 'Texas Stroke Institute, Dallas-Fort Worth, TX, USA.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Gerrits', 'Affiliation': 'Medisch Spectrum Twente, Enschede, Netherlands.'}, {'ForeName': 'Martine T B', 'Initials': 'MTB', 'LastName': 'Truijman', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Zinkstok', 'Affiliation': 'Tergooi, Hilversum, Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Koudstaal', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Manschot', 'Affiliation': 'Department of Neurology, Haaglanden Medical Centre, The Hague, Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Kerkhoff', 'Affiliation': 'Department of Neurology, Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Nieboer', 'Affiliation': 'Department of Public Health, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Olvert', 'Initials': 'O', 'LastName': 'Berkhemer', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands; Department of Radiology and Nuclear Medicine, Erasmus MC University Medical Center, Rotterdam, Netherlands; Department of Radiology & Nuclear Medicine, Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Lennard', 'Initials': 'L', 'LastName': 'Wolff', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'P Matthijs', 'Initials': 'PM', 'LastName': 'van der Sluijs', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'van Voorst', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands; Department of Biomedical Engineering and Physics, Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Tolhuisen', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands; Department of Biomedical Engineering and Physics, Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Staals', 'Affiliation': 'Department of Neurology, Maastricht University Medical Centre, Cardiovascular Research Institute Maastricht, Maastricht, Netherlands.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'van Oostenbrugge', 'Affiliation': 'Department of Neurology, Maastricht University Medical Centre, Cardiovascular Research Institute Maastricht, Maastricht, Netherlands.'}, {'ForeName': 'Sjoerd F M', 'Initials': 'SFM', 'LastName': 'Jenniskens', 'Affiliation': 'Department of Medical Imaging, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Lukas C', 'Initials': 'LC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Radiology, HagaZiekenhuis, The Hague, Netherlands.'}, {'ForeName': 'Heleen M', 'Initials': 'HM', 'LastName': 'den Hertog', 'Affiliation': 'Department of Neurology, Isala, Zwolle, Netherlands.'}, {'ForeName': 'Adriaan C G M', 'Initials': 'ACGM', 'LastName': 'van Es', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Aad', 'Initials': 'A', 'LastName': 'van der Lugt', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Roozenbeek', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, Netherlands; Department of Radiology and Nuclear Medicine, Erasmus MC University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(22)00014-9']
3218,35241720,"Effect of SGLT-2 inhibitor, empagliflozin, on blood pressure reduction in Chinese elderly hypertension patients with type 2 diabetes and its possible mechanisms.","The current study evaluated the effect of SGLT-2 inhibitor, empagliflozin, on blood pressure reduction in Chinese elderly hypertension patients with type 2 diabetes and investigated its possible mechanisms. 124 patients were randomized to receive 25 mg empagliflozin QD, or placebo double blind for 12 weeks. Patients underwent 24-h ABPM. Endothelial function and arterial stiffness were also measured prior to randomization and at week 12. At week 12, adjusted mean difference versus placebo in change from baseline in mean 24-h SBP was - 8.14 mmHg (95% CI - 10.32, - 3.96, P = 0.005). At week 12, adjusted mean difference versus placebo in change from baseline in mean 24-h DBP was - 5.27 mmHg (95% CI - 8.19, - 1.35, P < 0.001). Changes in office BP were consistent with ABPM. Empagliflozin was well tolerated. Empagliflozin was associated with significant and clinically meaningful reductions in BP versus placebo in Chinese elderly patients with type 2 diabetes and hypertension. The underlying mechanisms possiblely at least in part were the improvements of endothelial function and arterial stiffness associated with empagliflozin.Registration number: ChiCTR2100054678, Registration date: December 23, 2021.",2022,Empagliflozin was associated with significant and clinically meaningful reductions in BP versus placebo in Chinese elderly patients with type 2 diabetes and hypertension.,"['Chinese elderly patients with type 2 diabetes and hypertension', 'Chinese elderly hypertension patients with type 2 diabetes', '124 patients']","['24-h ABPM', 'placebo', 'empagliflozin QD, or placebo', 'empagliflozin', 'SGLT-2 inhibitor, empagliflozin', 'Empagliflozin']","['mean 24-h SBP', 'Endothelial function and arterial stiffness', 'mean 24-h DBP', 'tolerated', 'endothelial function and arterial stiffness', 'blood pressure reduction']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517553', 'cui_str': '124'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",124.0,0.273271,Empagliflozin was associated with significant and clinically meaningful reductions in BP versus placebo in Chinese elderly patients with type 2 diabetes and hypertension.,"[{'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': ""Jiangxi Provincial People's Hospital, Nanchang, 330006, Jiangxi, China.""}, {'ForeName': 'Qianyu', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': ""Jiangxi Provincial People's Hospital, Nanchang, 330006, Jiangxi, China.""}, {'ForeName': 'Longhua', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Jiangxi Provincial People's Hospital, Nanchang, 330006, Jiangxi, China.""}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Jiangxi Provincial People's Hospital, Nanchang, 330006, Jiangxi, China.""}, {'ForeName': 'Fenfen', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Jiangxi Provincial People's Hospital, Nanchang, 330006, Jiangxi, China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Jiangxi Provincial People's Hospital, Nanchang, 330006, Jiangxi, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Jiangxi Provincial People's Hospital, Nanchang, 330006, Jiangxi, China.""}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': ""Jiangxi Provincial People's Hospital, Nanchang, 330006, Jiangxi, China.""}, {'ForeName': 'Xiaohe', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Jiangxi Provincial People's Hospital, Nanchang, 330006, Jiangxi, China. wuxiaohe1964@163.com.""}]",Scientific reports,['10.1038/s41598-022-07395-x']
3219,35241690,Exploratory study reveals far reaching systemic and cellular effects of verapamil treatment in subjects with type 1 diabetes.,"Currently, no oral medications are available for type 1 diabetes (T1D). While our recent randomized placebo-controlled T1D trial revealed that oral verapamil had short-term beneficial effects, their duration and underlying mechanisms remained elusive. Now, our global T1D serum proteomics analysis identified chromogranin A (CHGA), a T1D-autoantigen, as the top protein altered by verapamil and as a potential therapeutic marker and revealed that verapamil normalizes serum CHGA levels and reverses T1D-induced elevations in circulating proinflammatory T-follicular-helper cell markers. RNA-sequencing further confirmed that verapamil regulates the thioredoxin system and promotes an anti-oxidative, anti-apoptotic and immunomodulatory gene expression profile in human islets. Moreover, continuous use of oral verapamil delayed T1D progression, promoted endogenous beta-cell function and lowered insulin requirements and serum CHGA levels for at least 2 years and these benefits were lost upon discontinuation. Thus, the current studies provide crucial mechanistic and clinical insight into the beneficial effects of verapamil in T1D.",2022,"Moreover, continuous use of oral verapamil delayed T1D progression, promoted endogenous beta-cell function and lowered insulin requirements and serum CHGA levels for at least 2 years and these benefits were lost upon discontinuation.",['subjects with type 1 diabetes'],"['placebo', 'verapamil']",['endogenous beta-cell function and lowered insulin requirements and serum CHGA levels'],"[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0055633', 'cui_str': 'Chromogranin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0760247,"Moreover, continuous use of oral verapamil delayed T1D progression, promoted endogenous beta-cell function and lowered insulin requirements and serum CHGA levels for at least 2 years and these benefits were lost upon discontinuation.","[{'ForeName': 'Guanlan', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Comprehensive Diabetes Center, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Tiffany D', 'Initials': 'TD', 'LastName': 'Grimes', 'Affiliation': 'Comprehensive Diabetes Center, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Truman B', 'Initials': 'TB', 'LastName': 'Grayson', 'Affiliation': 'Comprehensive Diabetes Center, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Junqin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Comprehensive Diabetes Center, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Lance A', 'Initials': 'LA', 'LastName': 'Thielen', 'Affiliation': 'Comprehensive Diabetes Center, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Hubert M', 'Initials': 'HM', 'LastName': 'Tse', 'Affiliation': 'Comprehensive Diabetes Center, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Comprehensive Diabetes Center, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Kanke', 'Affiliation': 'Department of Biomedical Sciences, College of Veterinary Medicine, Cornell University, Ithaca, NY, 14853, USA.'}, {'ForeName': 'Tai-Tu', 'Initials': 'TT', 'LastName': 'Lin', 'Affiliation': 'Biological Sciences Division, Pacific Northwest National Laboratory, Richland, WA, 99352, USA.'}, {'ForeName': 'Athena A', 'Initials': 'AA', 'LastName': 'Schepmoes', 'Affiliation': 'Biological Sciences Division, Pacific Northwest National Laboratory, Richland, WA, 99352, USA.'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Swensen', 'Affiliation': 'Biological Sciences Division, Pacific Northwest National Laboratory, Richland, WA, 99352, USA.'}, {'ForeName': 'Vladislav A', 'Initials': 'VA', 'LastName': 'Petyuk', 'Affiliation': 'Biological Sciences Division, Pacific Northwest National Laboratory, Richland, WA, 99352, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ovalle', 'Affiliation': 'Comprehensive Diabetes Center, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Sethupathy', 'Affiliation': 'Department of Biomedical Sciences, College of Veterinary Medicine, Cornell University, Ithaca, NY, 14853, USA.'}, {'ForeName': 'Wei-Jun', 'Initials': 'WJ', 'LastName': 'Qian', 'Affiliation': 'Biological Sciences Division, Pacific Northwest National Laboratory, Richland, WA, 99352, USA.'}, {'ForeName': 'Anath', 'Initials': 'A', 'LastName': 'Shalev', 'Affiliation': 'Comprehensive Diabetes Center, University of Alabama at Birmingham, Birmingham, AL, 35294, USA. shalev@uab.edu.'}]",Nature communications,['10.1038/s41467-022-28826-3']
3220,35241942,"The Relationship Between Postoperative Opioid Analgesia and Sleep Apnea Severity in Patients Undergoing Hip Arthroplasty: A Randomized, Controlled, Triple-Blinded Trial.","Purpose


Residual postoperative pain after hip arthroplasty is usually treated with oral opioids. While classic opioids are associated with respiratory depression and worsening of sleep apnea, tramadol has been reported to preserve respiratory function. However, this has not been investigated in a prospective trial using respiratory polygraphy. This randomized controlled triple-blinded trial tested the hypothesis that postoperative treatment with oral opioids such as oxycodone would increase sleep apnea severity, measured with a respiratory polygraphy, compared with oral tramadol.
Patients and Methods


Sixty patients undergoing hip arthroplasty under spinal anesthesia with 15 mg isobaric bupivacaine 0.5% were randomized to receive postoperative pain treatment with either oral oxycodone (controlled-release 10 mg every 12 hours and immediate-release 5 mg every 4 hours as needed) or oral tramadol (controlled-release 100 mg every 8 hours and immediate-release 50 mg every 4 hours as needed). Respiratory polygraphy was performed on the first postoperative night. The primary outcome was the apnea-hypopnea index in the supine position. Secondary outcomes included the oxygen desaturation index, postoperative pain scores and intravenous morphine consumption.
Results


Mean supine apnea-hypopnea index on postoperative night 1 was 11.3 events.h -1  (95% confidence interval, 4.8-17.7) in the oxycodone group and 10.7 (4.6-16.8) events.h -1  in the tramadol group (p=0.89). There were no significant differences between the oxycodone and tramadol groups with respect to any secondary sleep-related or pain-related outcomes.
Conclusion


Oral oxycodone did not increase sleep apnea severity measured using respiratory polygraphy compared with oral tramadol on the first postoperative night after hip arthroplasty.
Trial Registration Number


Clinicaltrials.gov - NCT03454217 (date of registration: 05/03/2018).",2022,"There were no significant differences between the oxycodone and tramadol groups with respect to any secondary sleep-related or pain-related outcomes.
","['Patients Undergoing Hip Arthroplasty', 'Patients and Methods\n\n\nSixty patients undergoing hip arthroplasty under spinal anesthesia with 15 mg']","['oral opioids', 'oxycodone', 'postoperative pain treatment with either oral oxycodone', 'oral opioids such as oxycodone', 'oral tramadol', 'isobaric bupivacaine']","['Mean supine apnea-hypopnea index on postoperative night 1', 'oxygen desaturation index, postoperative pain scores and intravenous morphine consumption', 'secondary sleep-related or pain-related outcomes', 'sleep apnea severity', 'apnea-hypopnea index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",60.0,0.108876,"There were no significant differences between the oxycodone and tramadol groups with respect to any secondary sleep-related or pain-related outcomes.
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Albrecht', 'Affiliation': 'Department of Anesthesia, University Hospital of Lausanne and University of Lausanne, Lausanne, Vaud, Switzerland.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pereira', 'Affiliation': 'Department of Anesthesia, University Hospital of Lausanne and University of Lausanne, Lausanne, Vaud, Switzerland.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Bayon', 'Affiliation': 'Center for Investigation and Research in Sleep, University Hospital of Lausanne and University of Lausanne, Lausanne, Vaud, Switzerland.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Berger', 'Affiliation': 'Center for Investigation and Research in Sleep, University Hospital of Lausanne and University of Lausanne, Lausanne, Vaud, Switzerland.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Wegrzyn', 'Affiliation': 'Department of Orthopedic Surgery, University Hospital of Lausanne and University of Lausanne, Lausanne, Vaud, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Antoniadis', 'Affiliation': 'Department of Orthopedic Surgery, University Hospital of Lausanne and University of Lausanne, Lausanne, Vaud, Switzerland.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Heinzer', 'Affiliation': 'Center for Investigation and Research in Sleep, University Hospital of Lausanne and University of Lausanne, Lausanne, Vaud, Switzerland.'}]",Nature and science of sleep,['10.2147/NSS.S348834']
3221,35241937,"Effectiveness of Breathing Exercises, Foot Reflexology and Massage (BRM) on Maternal and Newborn Outcomes Among Primigravidae in Saudi Arabia: A Randomized Controlled Trial.","Background


Labor pain and anxiety are important concerns during labor, especially among the primigravidae. It may increase the duration of labor, increase stress hormones, and affect maternal and new-born related outcomes. This study examined the effectiveness of combined breathing exercises, foot reflexology, and massage (BRM) interventions on labor pain, anxiety, labor duration, stress hormone levels, maternal satisfaction, maternal vital signs, and the new-born's APGAR scores.
Participants and Methods


This single-blind-parallel randomized controlled trial (RCT) was conducted at the Maternity and Children Hospital (MCH), Makkah, Saudi Arabia, by recruiting primigravidae aged 20 to 35 years, without any medical complications, and who were block-randomized at six-centimeter cervical dilation and stratified by intramuscular pethidine. The intervention is BRM compared to standard care. The labor pain was measured via present behavioral intensity (PBI) and visual analogue scale (VAS), and the anxiety was measured via Anxiety Assessment Scale for Pregnant Women in Labor (AASPWL). The secondary outcomes were duration of labor, maternal stress hormone levels, maternal vital signs, maternal satisfaction, fetal heart rate, and APGAR scores. All outcomes were measured at multiple time-points during and after contraction at baseline, during BRM intervention, at 60, 120, and 180 minutes post-intervention. Generalized linear mixed models were used to estimate the intervention effects over time.
Results


A total of 225 participants were randomized for the control (n = 112) and intervention group (113). BRM lowered the labor pain intensity at 60 minutes after intervention during (1.3 vs 3.5, F = 102.5, p < 0.001) and after contraction (0.4 vs 2.4, F = 63.6, p < 0.001) and also lowered anxiety (2.9 vs 4.2, F = 80.4, p < 0.001). BRM correspondingly lowered adrenocorticotropic (ACTH) (133 vs 209 pg/mL, p < 0.001), cortisol (1231 vs 1360 nmol/mL, p = 0.003), and oxytocin (159 vs 121 pg/mL, p < 0.001). It also shortened the labor duration (165 vs 333 minutes, p < 0.001), improved vital signs, which resulted in higher APGAR scores, and increased maternal satisfaction.
Conclusion


The labor unit management could consider adopting BRM as one of the non-pharmacological analgesia for healthy women in labor.
Trial Registration


ISRCTN87414969, registered 3 May 2019.",2022,"BRM correspondingly lowered adrenocorticotropic (ACTH) (133 vs 209 pg/mL, p < 0.001), cortisol (1231 vs 1360 nmol/mL, p = 0.003), and oxytocin (159 vs 121 pg/mL, p < 0.001).","['Participants and Methods\n\n\nThis single-blind-parallel randomized controlled trial (RCT) was conducted at the Maternity and Children Hospital (MCH), Makkah, Saudi Arabia, by recruiting primigravidae aged 20 to 35 years, without any medical complications, and who were block-randomized at six-centimeter cervical dilation and stratified by intramuscular', '225 participants were randomized for the control (n = 112) and intervention group (113', 'Primigravidae in Saudi Arabia', 'healthy women in labor']","['pethidine', 'Breathing Exercises, Foot Reflexology and Massage (BRM', 'oxytocin', 'combined breathing exercises, foot reflexology, and massage (BRM) interventions']","['duration of labor, maternal stress hormone levels, maternal vital signs, maternal satisfaction, fetal heart rate, and APGAR scores', 'labor duration', 'labor pain intensity', 'BRM correspondingly lowered adrenocorticotropic (ACTH', 'higher APGAR scores', 'maternal satisfaction', 'behavioral intensity (PBI) and visual analogue scale (VAS), and the anxiety was measured via Anxiety Assessment Scale', 'improved vital signs', 'cortisol', 'lowered anxiety', 'labor pain', 'duration of labor, increase stress hormones', 'Maternal and Newborn Outcomes', ""labor pain, anxiety, labor duration, stress hormone levels, maternal satisfaction, maternal vital signs, and the new-born's APGAR scores""]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0475210', 'cui_str': 'cm'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022864', 'cui_str': 'Labor'}]","[{'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]",225.0,0.129785,"BRM correspondingly lowered adrenocorticotropic (ACTH) (133 vs 209 pg/mL, p < 0.001), cortisol (1231 vs 1360 nmol/mL, p = 0.003), and oxytocin (159 vs 121 pg/mL, p < 0.001).","[{'ForeName': 'Kamilya', 'Initials': 'K', 'LastName': 'Baljon', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, 43400, Selangor, Malaysia.'}, {'ForeName': 'Muhammad Hibatullah', 'Initials': 'MH', 'LastName': 'Romli', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, 43400, Selangor, Malaysia.'}, {'ForeName': 'Adibah Hanim', 'Initials': 'AH', 'LastName': 'Ismail', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, 43400, Selangor, Malaysia.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Khuan', 'Affiliation': 'Department of Nursing, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Selangor, 43400, Malaysia.'}, {'ForeName': 'Boon-How', 'Initials': 'BH', 'LastName': 'Chew', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, 43400, Selangor, Malaysia.'}]",International journal of women's health,['10.2147/IJWH.S347971']
3222,35241779,"A randomized double-blind, placebo-controlled pilot trial of mirtazapine for anxiety in children and adolescents with autism spectrum disorder.","This study was a 10-week double-blind, placebo-controlled pilot trial of mirtazapine for anxiety in youth with autism spectrum disorder (ASD). Participants were ages 5 to 17 years with ASD and clinically significant anxiety (Pediatric Anxiety Rating Scale [PARS] score ≥10). Thirty participants were randomized to mirtazapine (7.5-45 mg/day) or placebo in a 2:1 ratio. The co-primary outcome measures were the PARS and the Clinical Global Impressions-Improvement subscale (CGI-I). Mirtazapine resulted in a statistically significant within group decrease in anxiety on the PARS (ES 1.76, p < 0.001). The improvement in PARS score for mirtazapine versus placebo was clinically meaningful but not statistically significant (ES = 0.63, p = 0.64). Forty-seven percent of participants assigned to mirtazapine (95% CI 22%: 74%) and 20% assigned to placebo (95% CI 2%: 60%) were rated ""much improved"" (CGI-I = 2) or ""very much improved"" (CGI-I = 1) for anxiety, p = 0.46. No statistically significant differences in mean 10-week changes between mirtazapine and placebo occurred on any outcome measure. There were no statistically significant differences in adverse effect frequency between mirtazapine and placebo. The results are consistent with mirtazapine's safety and tolerability and meet three of four pre-specified indicators of efficacy (statistically significant change in total PARS score for mirtazapine, numerically greater reduction in total PARS score for mirtazapine than placebo, numerically higher number of responders to mirtazapine than placebo, but not greater than 50% of participants receiving mirtazapine rated as responders). Implementation of a larger randomized controlled trial of mirtazapine for the treatment of anxiety in this population is supported.Clinical trial registration information: Mirtazapine Treatment of Anxiety in Children and Adolescents with Pervasive Developmental Disorders; https://clinicaltrials.gov ; NCT01302964.",2022,"Mirtazapine resulted in a statistically significant within group decrease in anxiety on the PARS (ES 1.76, p < 0.001).","['Thirty participants', 'Participants were ages 5 to 17 years with ASD and clinically', 'youth with autism spectrum disorder (ASD', 'children and adolescents with autism spectrum disorder', 'Children and Adolescents with Pervasive Developmental Disorders']","['mirtazapine and placebo', 'mirtazapine', 'Mirtazapine', 'placebo']","['total PARS score', 'PARS score', 'PARS and the Clinical Global Impressions-Improvement subscale (CGI-I', 'anxiety on the PARS', 'significant anxiety (Pediatric Anxiety Rating Scale [PARS] score ≥10', 'adverse effect frequency']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",30.0,0.741386,"Mirtazapine resulted in a statistically significant within group decrease in anxiety on the PARS (ES 1.76, p < 0.001).","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'McDougle', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA. cmcdougle@mgh.harvard.edu.'}, {'ForeName': 'Robyn P', 'Initials': 'RP', 'LastName': 'Thom', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA.'}, {'ForeName': 'Caitlin T', 'Initials': 'CT', 'LastName': 'Ravichandran', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Palumbo', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Politte', 'Affiliation': ""WakeMed Children's Pediatric Behavioral Health, 3000 New Bern Ave, Raleigh, NC, 27610, USA.""}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Mullett', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Keary', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Erickson', 'Affiliation': ""Division of Child and Adolescent Psychiatry, Cincinnati Children's Hospital Medical Center and the University of Cincinnati College of Medicine Department of Psychiatry and Behavioral Neuroscience, Cincinnati, USA.""}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Stigler', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, Indianapolis, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Mathieu-Frasier', 'Affiliation': ""Division of Child and Adolescent Psychiatry, Cincinnati Children's Hospital Medical Center and the University of Cincinnati College of Medicine Department of Psychiatry and Behavioral Neuroscience, Cincinnati, USA.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Posey', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, Indianapolis, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-022-01295-4']
3223,35241775,Analysis of serious adverse events in a pediatric community-acquired pneumonia randomized clinical trial in Malawi.,"Amoxicillin is recommended as first-line antibiotic treatment for community-acquired pneumonia, the leading infectious cause of mortality in children aged less than 5 years. We conducted a double-blind, randomized controlled non-inferiority trial comparing 3- to 5-day amoxicillin treatment for non-severe chest-indrawing pneumonia in HIV-negative children aged 2 to 59 months in Malawi. In a secondary analysis, we assessed the frequency of serious adverse events (SAEs) during the trial to evaluate the safety of treatment with amoxicillin. Enrolled children with non-severe chest-indrawing pneumonia were randomized to either 3- or 5-day amoxicillin and followed for 14 days to track clinical outcomes. In addition to evaluation for treatment failure (primary endpoint, day 6), relapse, and study drug adherence, children were assessed for adverse events, including SAEs, which were managed per local standard clinical practice until resolution or stabilization. Between March 2016 and April 2019, 3000 children were enrolled, with male and younger children (aged less than 24 months) demonstrating more SAEs (10.3% for males vs 8.1% for females, p = 0.04; 10.0% for 2-6 months, 10.8% for 7-11 months, 9.7% for 12-23 months and 5.6% for 24-59 months, p = 0.01). The most common SAEs were progression of or recurrent pneumonia (220 SAEs in 217 children), acute gastroenteritis (14 SAEs in 14 children), and fever (8 SAEs in 8 children); however, there were no significant or substantive differences in the percentage of children with pneumonia-related, acute gastroenteritis, or fever SAEs noted between the 3- versus 5-day amoxicillin treatment groups. In our pediatric community-acquired pneumonia trial evaluating amoxicillin treatment, there were relatively few SAEs overall and very few attributed to amoxicillin. Duration of amoxicillin treatment did not impact the frequency of SAEs. We found male and younger children appear to be more vulnerable to SAEs in our trial; however, our data support previous data demonstrating the safety of amoxicillin use in children with pneumonia.Clinical trial registration: ClinicalTrials.gov (NCT02678195).",2022,"The most common SAEs were progression of or recurrent pneumonia (220 SAEs in 217 children), acute gastroenteritis (14 SAEs in 14 children), and fever (8 SAEs in 8 children); however, there were no significant or substantive differences in the percentage of children with pneumonia-related, acute gastroenteritis, or fever SAEs noted between the 3- versus 5-day amoxicillin treatment groups.","['children aged less than 5\xa0years', 'non-severe chest-indrawing pneumonia in HIV-negative children aged 2 to 59\xa0months in Malawi', 'Between March 2016 and April 2019, 3000 children were enrolled, with male and younger children (aged less than 24\xa0months', 'male and younger children', 'children with pneumonia', 'pediatric community-acquired pneumonia randomized clinical trial in Malawi', 'Enrolled children with non-severe chest-indrawing pneumonia']","['3- or 5-day amoxicillin', 'amoxicillin', 'Amoxicillin']","['frequency of SAEs', 'frequency of serious adverse events (SAEs', 'SAEs', 'acute gastroenteritis', 'acute gastroenteritis, or fever SAEs', 'progression of or recurrent pneumonia', 'fever']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0694550', 'cui_str': 'Recurrent pneumonia'}]",3000.0,0.369464,"The most common SAEs were progression of or recurrent pneumonia (220 SAEs in 217 children), acute gastroenteritis (14 SAEs in 14 children), and fever (8 SAEs in 8 children); however, there were no significant or substantive differences in the percentage of children with pneumonia-related, acute gastroenteritis, or fever SAEs noted between the 3- versus 5-day amoxicillin treatment groups.","[{'ForeName': 'Amy Sarah', 'Initials': 'AS', 'LastName': 'Ginsburg', 'Affiliation': 'Clinical Trials Center, University of Washington, Building 29, Suite 250, 6200 NE 74th Street, Seattle, WA, 98115, USA. messageforamy@gmail.com.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'May', 'Affiliation': 'Clinical Trials Center, University of Washington, Building 29, Suite 250, 6200 NE 74th Street, Seattle, WA, 98115, USA.'}]",Scientific reports,['10.1038/s41598-022-07582-w']
3224,35242209,Changes of Mental State and Serum Prolactin Levels in Patients with Schizophrenia and Depression after Receiving the Combination Therapy of Amisulpride and Chloroprothixol Tablets.,"Objective


To investigate the changes in mental state and serum prolactin levels in patients with schizophrenia and depression after receiving the combination therapy of amisulpride and chloroprothixol tablets.
Methods


A total of 148 schizophrenic patients with depression were randomly divided into control group ( N  = 73) and study group ( N  = 75). The control group was treated with clopidothiol, and the study group was treated with amisulpride. Symptom scores, sleep quality, adverse reactions, therapeutic effects, prolactin, and progesterone levels, HAMD, PANSS, and PSP scores were compared between the two groups.
Results


The symptom scores of both groups were significantly reduced, but when compared to the control group, the symptom scores of the research group were significantly reduced more significantly ( P  < 0.05); serum GDNF levels of both groups were significantly increased, while serum NSE, IL-1, and MBP levels were significantly reduced ( P  < 0.05). However, the research group altered more substantially ( P  < 0.05) than the control group; the overall PSQI score of the research group was lower ( P  < 0.05) than the control group; and the incidence of adverse responses in the control and study groups was 12.3 percent and 4.0 percent. The research group had a lower rate of adverse responses ( P  < 0.05) than the control group, and the effective treatment of the control and research groups was 82.2 percent and 98.7%, respectively. The research group had a lower rate of adverse reactions ( P  < 0.05) than the control group, while the control and research groups' successful treatment rates were 82.2 percent and 98.7%, respectively. When compared to the control group, the research group had a greater treatment efficiency ( P  < 0.05); blood prolactin and progesterone levels were considerably lowered in both groups, but the reductions in the research group were more evident ( P  < 0.05). Both groups had considerably lower HAMD and PANSS scores, and both had significantly higher PSP scores, although the difference in the research group was more evident ( P  < 0.05).
Conclusion


For people with schizophrenia and depression, a combination of amisulpride and chloroprothixol pills has a considerable effect. It can help patients with their clinical symptoms and sleep quality while also lowering their serum prolactin levels, which is favorable to their illness recovery. As a result, the combined treatment of amisulpride and chloroprothixol pills deserves to be promoted and used.",2022,"When compared to the control group, the research group had a greater treatment efficiency ( P  < 0.05); blood prolactin and progesterone levels were considerably lowered in both groups, but the reductions in the research group were more evident ( P  < 0.05).","['148 schizophrenic patients with depression', 'Patients with Schizophrenia and Depression after Receiving the Combination Therapy of', 'patients with schizophrenia and depression after receiving the combination therapy of amisulpride and chloroprothixol tablets']","['amisulpride', 'amisulpride and chloroprothixol pills', 'Amisulpride and Chloroprothixol Tablets', 'clopidothiol']","['HAMD and PANSS scores', 'serum GDNF levels', 'overall PSQI score', 'rate of adverse responses', 'successful treatment rates', 'rate of adverse reactions', 'blood prolactin and progesterone levels', 'PSP scores', 'serum NSE, IL-1, and MBP levels', 'symptom scores', 'treatment efficiency', 'serum prolactin levels', 'mental state and serum prolactin levels', 'Mental State and Serum Prolactin Levels', 'Symptom scores, sleep quality, adverse reactions, therapeutic effects, prolactin, and progesterone levels, HAMD, PANSS, and PSP scores', 'incidence of adverse responses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0207072', 'cui_str': 'Glial Cell-Line Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0853129', 'cui_str': 'Blood prolactin'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C0038868', 'cui_str': 'Progressive supranuclear palsy'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0014063', 'cui_str': 'Myelin basic protein'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1277972', 'cui_str': 'Serum prolactin measurement'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",148.0,0.0178132,"When compared to the control group, the research group had a greater treatment efficiency ( P  < 0.05); blood prolactin and progesterone levels were considerably lowered in both groups, but the reductions in the research group were more evident ( P  < 0.05).","[{'ForeName': 'Bozhi', 'Initials': 'B', 'LastName': 'Yuan', 'Affiliation': 'Department of Psychiatry, Hanyang Hospital Affiliated to Wuhan University of Science and Technology, Wuhan 430051, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': 'Department of Psychiatry, Hanyang Hospital Affiliated to Wuhan University of Science and Technology, Wuhan 430051, China.'}]",Computational and mathematical methods in medicine,['10.1155/2022/6580030']
3225,35242203,Correlation Analysis and Intervention Study on Disturbance of Lipid Metabolism and Diabetic Peripheral Neuropathy.,"Objective


To explore the significance and clinical value of dynamic monitoring of lipid metabolism indexes in patients with diabetic peridiabetic lesions.
Methods


A total of 192 patients with type 2 diabetes (T2DM) treated in our hospital from October 2019 to July 2021 were divided into two groups according to whether they were complicated with peripheral neuropathy (DPN). The patients in the observation group were randomly assigned into group A ( n  = 45) and group B ( n  = 45) according to the method of random number table. The patients were assigned into control group ( n  = 102) and observation group ( n  = 90), and the patients in the observation group were randomly divided into two groups ( n  = 45). All the patients in the three groups were given routine hypoglycemic treatment, and group B was observed to dynamically monitor the indexes of lipid metabolism and regulate blood lipids on the basis of routine hypoglycemic treatment. The indexes of lipid metabolism, including total cholesterol (TC), triglyceride (TG), and high-density lipoprotein cholesterol (HDL-C)/low-density lipoprotein cholesterol (LDL-C), were detected before treatment. The receiver operating curve (ROC) was applied to elucidate the efficacy of TC, TG, and HDL-C and LDL-C in predicting peripheral neuropathy (DPN) in patients with T2DM. The indexes of lipid metabolism and neurological function of patients were determined after the treatment. The difference was considered to be statistically significant ( P  < 0.05).
Results


In contrast to the control, the serum levels of TG, TC, and LDL-C in the observation group were significantly higher, with HDL-C significantly lower. ROC curve analysis indicated that the area under the curve (AUC) of serum TG level to predict peripheral neuropathy in patients with T2DM was 0.753 (95% CI = 0.604 - 0.901,  P  = 0.007). When the Youden index reached the maximum (0.677), with corresponding sensitivity and specificity 77.18% and 82.58%, respectively, and the critical value was 2.31 mmol/L, the AUC of serum TC level for predicting peripheral neuropathy in patients with T2DM was 0.851 (95% CI = 0.735 ~ 0.967 P  < 0.001); when the Youden index reaches its maximum (0.750), with the sensitivity and specificity 84.44% and 92.06%, respectively, and the critical value is 4.52 mmol/L, the AUC of predicting peripheral neuropathy in patients with T2DM by serum LDL-C level was 0.799 (95% CI = 0.52 ~ 0.946,  P  = 0.001); when the Youden index reaches its maximum (0.706), with sensitivity and specificity 80.58% and 87.24%, respectively, and the critical value is 3.36 mmol/L, the AUC of serum HDL-C level for predicting DPN in patients with T2DM was 0.727 (95% CI = 0.568 ~ 0.886 P  = 0.014). When the Youden index reached the maximum (0.640), the sensitivity and specificity were 74.56% and 83.25%, respectively, the critical value is 1.51 mmol/L. The AUC in predicting DPN in patients with T2DM was 0.919 (95% CI = 0.839 ~ 0.978 P  < 0.001); when the Jordan index reached the maximum (0.786), the sensitivity and specificity were 91.75% and 95.82%, respectively. Compared with group A, the levels of serum TG, TC, and LDL-C in group B decreased significantly, while the level of HDL-C increased ( P  < 0.05). The motor nerve conduction velocity and sensory nerve conduction velocity of median nerve and peroneal nerve in group B were higher than those in group A ( P  < 0.05).
Conclusion


Diabetic patients with severe lipid metabolic disorders have a higher risk of DPN. Combined detection of lipid metabolism indexes such as TC, TG, and HDL-C and LDL-C is effective in predicting diabetic patients with DPN. In clinic, through dynamic monitoring of lipid metabolism indexes, we can actively regulate the level of blood lipids in patients with T2DM, which can delay the occurrence and development of DPN to a certain extent, as well as improving the prognosis of patients with diabetes.",2022,"The motor nerve conduction velocity and sensory nerve conduction velocity of median nerve and peroneal nerve in group B were higher than those in group A ( P  < 0.05).
","['diabetic patients with DPN', 'patients with diabetes', 'patients with T2DM', 'patients with diabetic peridiabetic lesions', 'Diabetic patients with severe lipid metabolic disorders', '192 patients with type 2 diabetes (T2DM) treated in our hospital from October 2019 to July 2021']",['routine hypoglycemic treatment'],"['levels of serum TG, TC, and LDL-C', 'AUC of serum HDL-C level', 'sensitivity and specificity', 'motor nerve conduction velocity and sensory nerve conduction velocity of median nerve and peroneal nerve', 'indexes of lipid metabolism, including total cholesterol (TC), triglyceride (TG), and high-density lipoprotein cholesterol (HDL-C)/low-density lipoprotein cholesterol (LDL-C', 'lipid metabolism and neurological function', 'level of HDL-C', 'serum LDL-C level', 'Disturbance of Lipid Metabolism and Diabetic Peripheral Neuropathy', 'serum levels of TG, TC, and LDL-C', 'efficacy of TC, TG, and HDL-C and LDL-C', 'area under the curve (AUC) of serum TG level to predict peripheral neuropathy', 'AUC of serum TC level']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0457379', 'cui_str': 'Motor nerve conduction velocity'}, {'cui': 'C0457378', 'cui_str': 'Sensory nerve conduction velocity'}, {'cui': 'C0025058', 'cui_str': 'Structure of median nerve'}, {'cui': 'C0031173', 'cui_str': 'Structure of common peroneal nerve'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]",192.0,0.0245521,"The motor nerve conduction velocity and sensory nerve conduction velocity of median nerve and peroneal nerve in group B were higher than those in group A ( P  < 0.05).
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, The First People's Hospital of Jiangxia District, Wuhan City, 430200 Hubei Province, China.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Endocrinology, The First People's Hospital of Jiangxia District, Wuhan City, 430200 Hubei Province, China.""}, {'ForeName': 'Yanzi', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': ""Department of Endocrinology, The First People's Hospital of Jiangxia District, Wuhan City, 430200 Hubei Province, China.""}]",Computational and mathematical methods in medicine,['10.1155/2022/2579692']
3226,35242016,The Role of Awareness on Motor-Sensory Temporal Recalibration.,"Temporal recalibration (TR) may arise to realign asynchronous stimuli after exposure to a short, constant delay between voluntary movement and sensory stimulus. The objective of this study was to determine if awareness of the temporal lag between a motor response (i.e., a keypress) and a sensory event (i.e., a visual flash) is necessary for TR to occur. We further investigated whether manipulating the required motor and perceptual judgment tasks modified the influence of awareness on TR. Participants ( n  = 48) were randomly divided between two groups (Group 1: Aware and Group 2: Unaware). The Aware group was told of the temporal lag between their keypress and visual flash at the beginning of the experiment, whereas the Unaware group was not. All participants completed eight blocks of trials, in which the motor task (single or repetitive tap), perceptual judgment task (judging the temporal order of the keypress in relation to the visual flash or judging whether the two stimuli were simultaneous or not), and fixed temporal lag between keypress and visual flash (0 or 100 ms) varied. TR was determined by comparing judgments between corresponding blocks of trials in which the temporal lag was 0 or 100 ms. Results revealed that both the Aware and Unaware groups demonstrated a similar magnitude of TR across all motor and perceptual judgment tasks, such that the magnitude of TR did not vary between Aware and Unaware participants. These results suggest that awareness of a temporal lag does not influence the magnitude of TR achieved and that motor and perceptual judgment task demands do not modulate the influence of awareness on TR.",2022,"Results revealed that both the Aware and Unaware groups demonstrated a similar magnitude of TR across all motor and perceptual judgment tasks, such that the magnitude of TR did not vary between Aware and Unaware participants.",['Participants ( n  = 48'],"['motor task (single or repetitive tap), perceptual judgment task (judging the temporal order of the keypress in relation to the visual flash or judging whether the two stimuli were simultaneous or not), and fixed temporal lag between keypress and visual flash']","['TR', 'visual flash']",[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}]",48.0,0.0976577,"Results revealed that both the Aware and Unaware groups demonstrated a similar magnitude of TR across all motor and perceptual judgment tasks, such that the magnitude of TR did not vary between Aware and Unaware participants.","[{'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Bubna', 'Affiliation': 'Sensorimotor Control Laboratory, Faculty of Health Sciences, School of Human Kinetics, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Melanie Y', 'Initials': 'MY', 'LastName': 'Lam', 'Affiliation': 'Perceptual-Motor Behaviour Laboratory, Department of Human Kinetics, Faculty of Science, St. Francis Xavier University, Antigonish, NS, Canada.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Cressman', 'Affiliation': 'Sensorimotor Control Laboratory, Faculty of Health Sciences, School of Human Kinetics, University of Ottawa, Ottawa, ON, Canada.'}]",Frontiers in integrative neuroscience,['10.3389/fnint.2022.747544']
3227,35242483,Investigating the Effect of the 10° Reverse Trendelenburg Position on Spinal Block Characteristics and Hemodynamic Parameters in Lower Limb Surgeries.,"INTRODUCTION


The primary goal of spinal anesthesia in lower limb surgeries is to achieve a successful sensory and motor block. Adequate level of spinal block for lower limb orthopedic surgery is T10. Due to multiple factors affecting the level of spinal anesthesia, it is not always easy to control the level of spinal anesthesia.We proposed that maintaining patients in a 10° reverse Trendelenburg position after spinal anesthesia can significantly control the height of the sensory block, resulting in stable hemodynamics.
MATERIALS AND METHODS


This study is a single centric, prospective, single-blinded randomized clinical trial (CTRI/2018/08/015455) conducted in a tertiary care center in Sub-Himalayan region in India from July 2018 to June 2019. Total 60 patients fulfilling our inclusion and exclusion criteria were recruited in the study and were divided into two groups. In the supine group, patients were positioned in the supine position, and in the Trendelenburg group, patients were positioned in a 10° reverse Trendelenburg position after administering spinal anesthesia with 12.5 mg bupivacaine heavy. The two groups were compared in terms of sensory block, motor block, and analgesia duration. Heart rate, blood pressure, mean arterial pressure, and hypotension were also compared between the two groups.
RESULTS


Duration of sensory block, motor block, and analgesia were significantly higher in patients of the reverse Trendelenburg group (group T) compared to the supine group (group S). In group T, 26.6% had a sensory block level above T8, whereas in group S, 86.6% of patients had a sensory block level above T8. No hypotension was observed in the Trendelenburg group, which was present in 33% of patients in the supine group (group S).
CONCLUSION


Ten-degree reverse Trendelenburg position immediately after giving spinal anesthesia significantly limits the level of sensory block and provides better hemodynamic stability, and can be more beneficial, especially in geriatric patients and other high-risk patients for lower limb surgeries.",2022,"RESULTS


Duration of sensory block, motor block, and analgesia were significantly higher in patients of the reverse Trendelenburg group (group T) compared to the supine group (group S).","['Total 60 patients fulfilling our inclusion and exclusion criteria were recruited in the study and were divided into two groups', 'tertiary care center in Sub-Himalayan region in India from July 2018 to June 2019', 'Lower Limb Surgeries']","['10° Reverse Trendelenburg Position', 'bupivacaine heavy', 'spinal anesthesia']","['Duration of sensory block, motor block, and analgesia', 'sensory block level', 'Heart rate, blood pressure, mean arterial pressure, and hypotension', 'sensory block, motor block, and analgesia duration', 'hypotension']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0277813', 'cui_str': 'Inverse Trendelenburg position'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",60.0,0.064979,"RESULTS


Duration of sensory block, motor block, and analgesia were significantly higher in patients of the reverse Trendelenburg group (group T) compared to the supine group (group S).","[{'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Anesthesiology, Civil Hospital, Thural, IND.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Bhandari', 'Affiliation': 'Anesthesiology, Dr. Rajendra Prasad Government Medical College and Hospital, Kangra, IND.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Thakur', 'Affiliation': 'Anesthesiology, Dr. Rajendra Prasad Government Medical College and Hospital, Kangra, IND.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Thakur', 'Affiliation': 'Anesthesiology, Dr. Radhakrishnan Government Medical College, Hamirpur, IND.'}, {'ForeName': 'Ravinder', 'Initials': 'R', 'LastName': 'Verma', 'Affiliation': 'Anesthesiology and Critical Care, Dr. Rajendra Prasad Government Medical College and Hospital, Kangra, IND.'}, {'ForeName': 'Bhanu', 'Initials': 'B', 'LastName': 'Awasthi', 'Affiliation': 'Orthopedics and Trauma, Dr. Rajendra Prasad Government Medical College and Hospital, Kangra, IND.'}]",Cureus,['10.7759/cureus.22588']
3228,35242458,Comparison of Frequency and Morbidity of Unilateral Total Knee Replacement Versus Simultaneous Bilateral Total Knee Replacement.,"Introduction Total knee replacement (TKR) is a procedure that is often performed on patients who have advanced osteoarthritis and has become more common. Bilateral TKR can be done at the same time and can save time, anesthesia and cost of multiple procedures. Objective To determine the frequency of unilateral and simultaneous bilateral total knee replacement and then compare their outcomes. Methods A total of 95 patients were included and were divided into two groups, i.e., patients undergoing unilateral TKR were grouped as group A and patients undergoing bilateral TKR were grouped as group B. Then patients underwent surgery under general anesthesia. All patients were followed up in the outpatient department (OPD). During follow-up, patients were evaluated for the outcome, i.e., cardiac event, urinary tract infection and surgical site infection. All this information was recorded on proforma while analyzed in SPSS v. 22 (IBM Corp., Armonk, NY). The outcome was compared in both groups by using chi-square test. The P-value ≤ 0.05 was considered as significant. Results The mean age of patients was 63.00 ± 6.17 years. There were 50 (52.6%) males and 45 (47.4%) females. The mean BMI of females was 27.93 ± 2.43 kg/m 2 . There were 47 (49.5%) patients who underwent simultaneous bilateral surgery while 48 (50.5%) underwent unilateral surgery. It has been observed that after surgery, the cardiac event occurred in one (1.1%) case and that case was from unilateral surgery group; urinary tract infection occurred in four cases, two (4.3%) were from bilateral cases while two (4.2%) were from the unilateral group and surgical site infection occurred in four cases, two (4.3%) were from bilateral cases while two (4.2%) were from the unilateral group. The difference was insignificant in both groups (p>0.05). Conclusion Thus, there was no significant difference observed between both groups regarding complications after surgery.",2022,The difference was insignificant in both groups (p>0.05).,"['All patients were followed up in the outpatient department (OPD', '95 patients', 'There were 50 (52.6%) males and 45 (47.4%) females', 'The mean age of patients was 63.00 ± 6.17 years', 'patients who have advanced osteoarthritis']","['unilateral surgery', 'Introduction Total knee replacement (TKR', 'unilateral TKR', 'bilateral TKR', 'Unilateral Total Knee Replacement Versus Simultaneous Bilateral Total Knee Replacement', 'surgery under general anesthesia', 'simultaneous bilateral surgery']","['urinary tract infection', 'cardiac event', 'cardiac event, urinary tract infection and surgical site infection', 'surgical site infection', 'mean BMI of females']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",95.0,0.0341262,The difference was insignificant in both groups (p>0.05).,"[{'ForeName': 'Muhammad Asad', 'Initials': 'MA', 'LastName': 'Arif', 'Affiliation': 'Orthopaedics and Trauma, Shifa International Hospital Islamabad, Islamabad, PAK.'}, {'ForeName': 'Sohail', 'Initials': 'S', 'LastName': 'Hafeez', 'Affiliation': 'Orthopaedics and Trauma, Shifa International Hospital Islamabad, Islamabad, PAK.'}]",Cureus,['10.7759/cureus.21655']
3229,35242377,The combination of folate receptor-positive circulating tumor cells and serum tumor markers suggests a histological diagnosis of lung cancer.,"Background


Folate-receptor alpha (FRα) is overexpressed in lung carcinoma. The FR-positive circulating tumor cell (FR+ CTC) has been established to be a non-invasive biomarker for lung cancer diagnosis. In this study, we sought to examine the value of FR+ CTC in the histological diagnosis of suspicious space-occupying pulmonary lesions.
Methods


A total of 538 patients with suspicious space-occupying pulmonary lesions were enrolled in this study. FR+ CTCs were detected before treatment initiation using negative enrichment and ligand-targeted polymerase chain reaction assays. The enrolled patients concurrently received serum biomarker tests.
Results


A total of 282 lung cancer patients [163 with adenocarcinoma (ADC), 71 with squamous cell carcinoma (SCC), and 48 with small cell lung cancer (SCLC)], and 256 patients with benign disease who concurrently received FR+ CTC and serum biomarker tests were randomly assigned to a training set and a validation set. The FR+ CTC levels of patients with lung cancer were significantly higher than those of patients with benign disease (P<0.001). Compared to serum tumor biomarkers alone, the model combining FR+ CTC and serum biomarkers had the highest area under the receiver operating characteristic curve in the diagnosis of NSCLC, ADC, SCC, and SCLC.
Conclusions


Diagnostic models that include both FR+ CTC and serum biomarkers could increase the efficiency of distinguishing between different histological types of lung cancer and benign space-occupying pulmonary diseases.",2022,The FR+ CTC levels of patients with lung cancer were significantly higher than those of patients with benign disease (P<0.001).,"['538 patients with suspicious space-occupying pulmonary lesions', '282 lung cancer patients [163 with adenocarcinoma (ADC), 71 with squamous cell carcinoma (SCC), and 48 with small cell lung cancer (SCLC)], and 256 patients with benign disease who concurrently received FR+ CTC and serum biomarker tests', 'lung carcinoma']","['serum biomarker tests', 'FR+ CTC', '\n\n\nFolate-receptor alpha (FRα']","['FR+ CTCs', 'FR+ CTC levels of patients with lung cancer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0684249', 'cui_str': 'Lung carcinoma'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C1384573', 'cui_str': 'FOLR1 protein, human'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]",538.0,0.0766127,The FR+ CTC levels of patients with lung cancer were significantly higher than those of patients with benign disease (P<0.001).,"[{'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': ""Department of Pulmonary and Critical Care Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': ""Department of Pulmonary and Critical Care Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Pulmonary and Critical Care Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""Department of Pulmonary and Critical Care Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Chang', 'Affiliation': ""Department of Pulmonary and Critical Care Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Pulmonary and Critical Care Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Ti', 'Affiliation': ""Department of Pulmonary and Critical Care Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}]",Journal of thoracic disease,['10.21037/jtd-21-1975']
3230,35242650,Efficacy of phentolamine combined with ambroxol aerosol inhalation in the treatment of pediatric severe pneumonia and its effect on serum IL-10 and CRP levels.,"Background


The aim of the present study was to determine the therapeutic effect of phentolamine combined with Ambroxol aerosol inhalation on pediatric severe pneumonia and its effect on serum interleukin-10 (IL-10) and C-reactive protein (CRP) levels.
Methods


Eighty-five children with severe pneumonia treated in our hospital from November 2019 to November 2020 were selected as the research participants, and were divided into the routine group (n=41) and treatment group (n=44) according to odd and even admission numbers, respectively. Children in the first group received routine treatment, namely symptomatic treatment such as cough relief (e.g., expectorant) and defervescence, while those in the second group received phentolamine combined with Ambroxol aerosol inhalation. Clinical indexes of both groups before and after treatment were analyzed to determine the therapeutic effect of different treatment methods and serum IL-10 and CRP level changes.
Results


There was no significant difference in general clinical data between the 2 groups (P>0.05). The duration of cough, fever, abnormal lung sound and lung shadow, and hospitalization time in the treatment group was significantly shorter than those in the routine group (P<0.001). The total clinical effective rate in the treatment group was significantly higher than that in the routine group (P<0.05). Forced vital capacity and peak expiratory flow rate levels were higher in both groups after treatment (P<0.05), and these were higher in the treatment group compared with the routine group after treatment (P<0.05). Serum IL-10 and CRP levels at T1 (2 days after treatment), T2 (5 days after treatment), and T3 (7 days after treatment) in the treatment group were significantly lower than those in the routine group (P<0.001). The total incidence of adverse reactions in the treatment group was significantly lower than that in the routine group (P<0.05).
Conclusions


Phentolamine combined with Ambroxol aerosol inhalation can significantly improve the clinical symptoms of children with severe pneumonia, reduce the body's inflammatory response, and improve lung function safely.",2022,"Forced vital capacity and peak expiratory flow rate levels were higher in both groups after treatment (P<0.05), and these were higher in the treatment group compared with the routine group after treatment (P<0.05).","['children with severe pneumonia', 'Methods\n\n\nEighty-five children with severe pneumonia treated in our hospital from November 2019 to November 2020 were selected as the research participants', 'pediatric severe pneumonia']","['phentolamine combined with Ambroxol aerosol inhalation', 'Phentolamine', 'phentolamine combined with ambroxol aerosol inhalation', 'Ambroxol aerosol inhalation']","['Serum IL-10 and CRP levels', 'pediatric severe pneumonia', 'duration of cough, fever, abnormal lung sound and lung shadow, and hospitalization time', 'general clinical data', 'total incidence of adverse reactions', 'Forced vital capacity and peak expiratory flow rate levels', 'serum IL-10 and CRP level changes', 'serum interleukin-10 (IL-10) and C-reactive protein (CRP) levels', 'serum IL-10 and CRP levels', 'total clinical effective rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0031448', 'cui_str': 'Phentolamine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002421', 'cui_str': 'Ambroxol'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0035234', 'cui_str': 'Respiratory sounds'}, {'cui': 'C0476367', 'cui_str': 'Shadow of lung'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",85.0,0.0470767,"Forced vital capacity and peak expiratory flow rate levels were higher in both groups after treatment (P<0.05), and these were higher in the treatment group compared with the routine group after treatment (P<0.05).","[{'ForeName': 'Junxia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Yantai Mountain Hospital, Yantai, China.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Pediatrics, Yantai Mountain Hospital, Yantai, China.'}, {'ForeName': 'Jingyao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of ICU Medicine, The Fourth People's Hospital of Jinan, Jinan, China.""}]",Translational pediatrics,['10.21037/tp-21-516']
3231,35242605,An examination of neurocognition and theory of mind as predictors of engagement with a tailored digital therapeutic in persons with serious mental illness.,"There is an increasing interest in the development and implementation of digital therapeutics (apps) in individuals with serious mental illness (SMI). However, there is limited understanding of the role of neurocognition and social cognition on engagement with apps. The present study is a secondary analysis of a pilot randomized controlled trial ( N  = 62) comparing a tailored digital intervention to treat tobacco use disorder in individuals with SMI to a standard of care digital intervention for the general population. The purpose of this study was to examine the impact of neurocognition, social cognition, and clinical characteristics on indices of app engagement in users of the tailored app compared to users of the standard of care app. Correlational analyses demonstrated that individuals with low levels of neurocognition and social cognition engaged more often and for longer duration with the tailored app compared to the standard of care app. In a series of multilevel zero-inflated negative binomial models, assignment to the tailored app remained the most robust predictor of app interactions (Risk Ratio [RR] = 1.72;  p  < .01), duration of app use (RR = 6.47; p < .01), and average length of interaction (RR = 2.70; p < .01), after adjusting for key demographic and clinical characteristics, and two measures of cognition. This is one of the first studies to demonstrate that digital therapeutics can be designed to mitigate the impact of neurocognition and social cognition on device engagement in SMI populations. Recommendations are made to advance the use of new analytic models to uncover patterns of engagement with digital therapeutics.",2022,Correlational analyses demonstrated that individuals with low levels of neurocognition and social cognition engaged more often and for longer duration with the tailored app compared to the standard of care app.,"['users of the tailored app compared to users of the standard of care app', 'individuals with serious mental illness (SMI', 'individuals with SMI to a standard of care digital intervention for the general population', 'persons with serious mental illness']",['tailored digital intervention'],['average length of interaction'],"[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",62.0,0.0556801,Correlational analyses demonstrated that individuals with low levels of neurocognition and social cognition engaged more often and for longer duration with the tailored app compared to the standard of care app.,"[{'ForeName': 'Tate F', 'Initials': 'TF', 'LastName': 'Halverson', 'Affiliation': 'Durham VA Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Browne', 'Affiliation': 'Durham VA Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Thomas', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Palenski', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, The University of Alabama at Birmingham, Birmingham, AL, United States of America.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Vilardaga', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of america.'}]",Schizophrenia research. Cognition,['10.1016/j.scog.2022.100236']
3232,35242595,Guided internet-based cognitive behavioral therapy for obsessive-compulsive disorder: A multicenter randomized controlled trial in Japan.,"Few studies have compared the effectiveness of internet-based cognitive behavior therapy (ICBT) for obsessive-compulsive disorder (OCD) with treatment as usual (TAU). We investigated the effectiveness of guided ICBT for patients with OCD. This prospective, randomized, controlled, assessor-blinded, multicenter clinical trial was conducted at three facilities in Japan from January 2020 to March 2021. Thirty-one patients with OCD as the primary diagnosis participated in the trial and were randomly assigned to either the intervention group or the control group. The primary outcome was the Yale-Brown obsessive-compulsive scale score; the assessors were blinded. Results of the analysis of covariance among the groups were significantly different between the groups ( p  < 0.01, effect size Cohen's  d  = 1.05), indicating the superiority of guided ICBT. The results suggest that guided ICBT is more effective than TAU for treating OCD.
RCT registration


UMIN Clinical Trials Registry (UMIN000039375).",2022,"Results of the analysis of covariance among the groups were significantly different between the groups ( p  < 0.01, effect size Cohen's  d  = 1.05), indicating the superiority of guided ICBT.","['obsessive-compulsive disorder', 'three facilities in Japan from January 2020 to March 2021', 'patients with OCD', 'Thirty-one patients with OCD as the primary diagnosis participated in the trial']","['internet-based cognitive behavior therapy (ICBT', 'Guided internet-based cognitive behavioral therapy', 'guided ICBT']",['Yale-Brown obsessive-compulsive scale score'],"[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",31.0,0.0661203,"Results of the analysis of covariance among the groups were significantly different between the groups ( p  < 0.01, effect size Cohen's  d  = 1.05), indicating the superiority of guided ICBT.","[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Research Center for Child Mental Development, Chiba University, Chiba 260-8588, Japan.'}, {'ForeName': 'Sayo', 'Initials': 'S', 'LastName': 'Hamatani', 'Affiliation': 'Research Center for Child Mental Development, Chiba University, Chiba 260-8588, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Makino', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Fukui 910-1192, Japan.'}, {'ForeName': 'Jumpei', 'Initials': 'J', 'LastName': 'Takahashi', 'Affiliation': 'Research Center for Child Mental Development, Chiba University, Chiba 260-8588, Japan.'}, {'ForeName': 'Futoshi', 'Initials': 'F', 'LastName': 'Suzuki', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Fukui 910-1192, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Ida', 'Affiliation': 'Department of Child Development, United Graduate School of Child Development, University of Fukui, Fukui 910-1193, Japan.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Hamamura', 'Affiliation': 'Department of Child Development, United Graduate School of Child Development, University of Fukui, Fukui 910-1193, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Child Development, United Graduate School of Child Development, University of Fukui, Fukui 910-1193, Japan.'}, {'ForeName': 'Akemi', 'Initials': 'A', 'LastName': 'Tomoda', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Fukui 910-1192, Japan.'}, {'ForeName': 'Ichiro M', 'Initials': 'IM', 'LastName': 'Omori', 'Affiliation': 'Department of Child Development, United Graduate School of Child Development, University of Fukui, Fukui 910-1193, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Kosaka', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Fukui 910-1192, Japan.'}, {'ForeName': 'Seina', 'Initials': 'S', 'LastName': 'Shinno', 'Affiliation': 'Department of Integrated Medical Sciences, Graduate School of Medicine, University of Fukui, Fukui 910-1192, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Ikai', 'Affiliation': 'Department of Primary Health Care, Faculty of Medicine, University of Fukui, Fukui 910-1192, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Department of Integrated Advanced Medicine, Graduate School of Medicine, University of Fukui, Fukui 910-1192, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'Kokorotokarada Clinic Fukui, Fukui 910-0067, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Shiko', 'Affiliation': 'Biostatistics Section Clinical Research Center, Chiba University Hospital, Chiba 260-8677, Japan.'}, {'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Ozawa', 'Affiliation': 'Biostatistics Section Clinical Research Center, Chiba University Hospital, Chiba 260-8677, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Biostatistics Section Clinical Research Center, Chiba University Hospital, Chiba 260-8677, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Sutoh', 'Affiliation': 'Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Chiba University, Chiba 260-8588, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Shimizu', 'Affiliation': 'Research Center for Child Mental Development, Chiba University, Chiba 260-8588, Japan.'}]",Internet interventions,['10.1016/j.invent.2022.100515']
3233,35242594,Economic evaluation alongside a randomized controlled trial of blended cognitive-behavioral therapy for patients suffering from major depressive disorder.,"Objective


This study aimed to investigate the cost-effectiveness of blended cognitive-behavioral therapy (CBT) compared to standard CBT for adult patients suffering from major depressive disorder (MDD).
Design


A cost-utility analysis alongside the randomized controlled ENTER trial.
Setting


Center for Telepsychiatry, Mental Health Services in the Region of Southern Denmark, Denmark.
Participants


The study included 76 patients suffering from MDD.
Interventions


The patients in the intervention group received blended CBT treatment comprising a combination of online modules and face-to-face consultations with a psychologist. The patients in the control group received standard CBT treatment, that is, solely face-to-face consultations with a psychologist. The treatment period was 12 weeks.
Outcome measures


Cost-effectiveness was reported as incremental cost-effectiveness ratio. A micro-costing approach was applied to evaluate the savings derived. Changes in quality-adjusted life-years (QALYs) were estimated using the EuroQol 5-Dimensions 5-Levels questionnaire at the baseline and the six-month follow-up.
Results


Data for 74 patients were included in the primary analysis. The adjusted QALY difference between blended CBT and standard CBT was -0.0291 (95% CI: -0.0535 to -0.0047), and the adjusted difference in costs was -£226.32 (95% CI: -300.86 to -151.77). Blended CBT was estimated to have a 6.6% and 3.1% probability of being cost-effective based on thresholds of £20,000 and £30,000.
Conclusion


Compared to standard CBT, blended CBT represents a cost-saving but also a loss in QALYs for patients suffering from MDD. However, results should be carefully interpreted, given the small sample size. Future research involving larger replication studies focusing on other aspects of blended CBT with more patient involvement is advised.
Trial registration number


ClinicalTrial.gov: S-20150150.",2022,"Compared to standard CBT, blended CBT represents a cost-saving but also a loss in QALYs for patients suffering from MDD.","['74 patients were included in the primary analysis', 'adult patients suffering from major depressive disorder (MDD', 'Participants\n\n\nThe study included 76 patients suffering from MDD', 'patients suffering from major depressive disorder', 'patients suffering from MDD', 'Setting\n\n\nCenter for Telepsychiatry, Mental Health Services in the Region of Southern Denmark, Denmark']","['standard CBT, blended CBT', 'blended CBT treatment comprising a combination of online modules and face-to-face consultations with a psychologist', 'standard CBT treatment', 'standard CBT', 'blended cognitive-behavioral therapy (CBT', 'blended cognitive-behavioral therapy']","['incremental cost-effectiveness ratio', 'quality-adjusted life-years (QALYs', 'Cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",76.0,0.0754692,"Compared to standard CBT, blended CBT represents a cost-saving but also a loss in QALYs for patients suffering from MDD.","[{'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Langergaard', 'Affiliation': 'Danish Center for Healthcare Improvements, Department of Clinical Medicine, Aalborg University, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mathiasen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Søndergaard', 'Affiliation': 'Danish Center for Healthcare Improvements, Department of Clinical Medicine, Aalborg University, Denmark.'}, {'ForeName': 'Sabrina S', 'Initials': 'SS', 'LastName': 'Sørensen', 'Affiliation': 'Danish Center for Healthcare Improvements, Department of Clinical Medicine, Aalborg University, Denmark.'}, {'ForeName': 'Sidsel L', 'Initials': 'SL', 'LastName': 'Laursen', 'Affiliation': 'Danish Center for Healthcare Improvements, Department of Clinical Medicine, Aalborg University, Denmark.'}, {'ForeName': 'Alexander A P', 'Initials': 'AAP', 'LastName': 'Xylander', 'Affiliation': 'Medical Informatics, Department of Health Science and Technology, Aalborg University, Denmark.'}, {'ForeName': 'Mia B', 'Initials': 'MB', 'LastName': 'Lichtenstein', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Denmark.'}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Ehlers', 'Affiliation': 'Danish Center for Healthcare Improvements, Department of Clinical Medicine, Aalborg University, Denmark.'}]",Internet interventions,['10.1016/j.invent.2022.100513']
3234,35242593,An internet-based treatment for flying phobia using 360° images: A feasibility pilot study.,"Background


More research is needed in the field of Internet-delivered Cognitive Behavioral Treatments (ICBTs) for specific phobia in order to understand which characteristics are important in online exposure scenarios. The aim of the present work was to conduct a feasibility pilot study to explore participants' opinions, preferences, and acceptability ratings of two types of images (still images vs 360° navigable images) in an ICBT for Flying Phobia (FP). A secondary aim was to test the potential effectiveness of the two active treatment arms compared to a waiting list control group. An exploratory aim was to compare the role of navigable images vs. still images in the level of sense of presence and reality judgment and explore their possible mediation in treatment effectiveness.
Methods


Participants were randomly allocated to three conditions: NO-FEAR Airlines with still images ( n  = 26), NO-FEAR Airlines with still and navigable images (n = 26), and a waiting list group (n = 26). Primary outcome measures were participants' opinions, preferences, satisfaction, and acceptance regarding the images used in the exposure scenarios. Secondary outcome measures included FP symptomatology outcomes and measures of sense of presence and reality judgment.
Results


Participants in the study preferred navigable images over still images before and after treatment (over 84%), and they considered them more effective and logical for the treatment of their problem. However, adherence in the experimental conditions was low (42.3% dropout rate), and more participants withdrew from the group that included navigable images compared to the group that only included still images (14 vs. 8), with no statistical differences in attrition between the two conditions. NO-FEAR Airlines proved to be effective in reducing FP symptomatology compared to the control group, with large between-group effect sizes on all FP measures (ranging from 0.76 to 2.79). No significant mediation effect was found for sense of presence or reality judgment in treatment effectiveness.
Discussion


The results of the current study suggest that participants prefer more immersive images in exposure scenarios, providing data that can help to design useful exposure scenarios to treat specific phobias in the future. They also provide evidence supporting the effectiveness of an ICBT for FP.
Trial registration


Registered at Clinicaltrials.gov (NCT03900559) on April 9, 2019. Retrospectively registered.",2022,"NO-FEAR Airlines proved to be effective in reducing FP symptomatology compared to the control group, with large between-group effect sizes on all FP measures (ranging from 0.76 to 2.79).",['360° navigable images) in an ICBT for Flying Phobia (FP'],"['NO-FEAR Airlines with still images ( n \xa0=\xa026), NO-FEAR Airlines with still and navigable images']","['FP symptomatology', ""participants' opinions, preferences, satisfaction, and acceptance regarding the images used in the exposure scenarios"", 'FP symptomatology outcomes and measures of sense of presence and reality judgment', 'FP measures']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0344318', 'cui_str': 'Flying phobia'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0344318', 'cui_str': 'Flying phobia'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}]",,0.0897982,"NO-FEAR Airlines proved to be effective in reducing FP symptomatology compared to the control group, with large between-group effect sizes on all FP measures (ranging from 0.76 to 2.79).","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Mor', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Campos', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, Huesca, Spain.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Cintia', 'Initials': 'C', 'LastName': 'Tur', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Quero', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}]",Internet interventions,['10.1016/j.invent.2022.100510']
3235,35242590,Stimulating a future-oriented mindset and goal attainment through a smartphone-based intervention: Study protocol for a randomized controlled trial.,"Background


Short-term mindsets interfere with the consideration of future consequences and therefore predict negative behaviors. We developed a smartphone-based intervention aiming to increase a future-oriented mindset and personal goal attainment by strengthening future self-identification and stimulating episodic future thinking. The aims of the study are 1) to examine users' experiences with the application and their treatment adherence, 2) to examine the effectiveness of the intervention, and 3) to explore which intervention modules generate the strongest changes in key outcomes.
Methods


First-year university students ( N  = 166) will be randomly assigned to two conditions: 1) the smartphone-based intervention, or 2) a goal-setting control group. The intervention consists of three week-long modules. Data will be collected at the start of the intervention, at weekly intervals during the intervention, immediately after the intervention, and at 3-month follow-up (and at parallel time points for the control group). We will assess users' experiences, application usage data, primary intervention outcomes (e.g., self-defeating behavior, future orientation, future self-identification), and secondary intervention outcomes (e.g., psychosocial wellbeing, self-efficacy).
Discussion


The study will provide information about users' experiences with the application, the intervention's general effectiveness, and which intervention modules show most promise. This information will be used to further develop the application and optimize this novel intervention.
Trial registration


The trial is registered in the Netherlands Trial Register (number: NL9671) on 16 August 2021.",2022,"The study will provide information about users' experiences with the application, the intervention's general effectiveness, and which intervention modules show most promise.","['Methods\n\n\nFirst-year university students ( N \xa0=\xa0166', 'Netherlands Trial Register (number: NL9671) on 16 August 2021']","['smartphone-based intervention, or 2) a goal-setting control group']","['psychosocial wellbeing, self-efficacy']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",166.0,0.0601989,"The study will provide information about users' experiences with the application, the intervention's general effectiveness, and which intervention modules show most promise.","[{'ForeName': 'Esther C A', 'Initials': 'ECA', 'LastName': 'Mertens', 'Affiliation': 'Institute of Education and Child Studies, Leiden University, the Netherlands.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van der Schalk', 'Affiliation': 'Institute of Education and Child Studies, Leiden University, the Netherlands.'}, {'ForeName': 'Aniek M', 'Initials': 'AM', 'LastName': 'Siezenga', 'Affiliation': 'Institute of Education and Child Studies, Leiden University, the Netherlands.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'van Gelder', 'Affiliation': 'Institute of Education and Child Studies, Leiden University, the Netherlands.'}]",Internet interventions,['10.1016/j.invent.2022.100509']
3236,35242535,"Reply to ""The discussion on the validity of sham controls and patient blinding in a sham-controlled acupuncture trial"" [Integr Med Res 2022; 11: 100795].",,2022,,[],[],[],[],[],[],,0.385743,,"[{'ForeName': 'Mikyung', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, College of Korean Medicine, Sangji University, Wonju, South Korea.'}, {'ForeName': 'O-Jin', 'Initials': 'OJ', 'LastName': 'Kwon', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.'}, {'ForeName': 'Jun-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.'}, {'ForeName': 'Joo-Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Sangji University, Wonju, South Korea.'}]",Integrative medicine research,['10.1016/j.imr.2022.100837']
3237,35242500,Protocol: A randomized controlled trial to assess effectiveness of a 12-month lifestyle intervention to reduce cardiovascular disease risk in families ten years after pre-eclampsia (FINNCARE).,"Pre-eclampsia (PE) is a multisystem progressive disorder affecting 3-5% of pregnancies. PE independently increases the risk for premature cardiovascular disease (CVD) in mothers and their children long-term. The effectiveness of a family-centered lifestyle intervention to lower CVD risk in PE families has not previously been evaluated. In the current FINNCARE study, we prospectively compare CVD risk and CVD progression in PE families (mother, father and child) in a cross-sectional study setting 8-12 years from delivery with non-PE control families of comparable age. Furthermore, we evaluate the effectiveness and feasibility of an interactive web-based behavioral 12-month lifestyle intervention to reduce blood pressure and the CVD risk profile overall in a randomized controlled trial. In total, 300 PE families will be randomized 1:1 to a PE-intervention or a PE-control group, and the 100 non-PE control families similarly followed-up at 12 months. Primary outcome is 24-hour mean systolic BP change from baseline in mother and child. Study aims to provide information on CVD progression and CVD risk management in the family following PE.",2022,PE independently increases the risk for premature cardiovascular disease (CVD) in mothers and their children long-term.,"['300 PE families', 'families ten years after pre-eclampsia (FINNCARE']","['interactive web-based behavioral 12-month lifestyle intervention', 'lifestyle intervention', 'family-centered lifestyle intervention']","['cardiovascular disease risk', '24-hour mean systolic BP change', 'premature cardiovascular disease (CVD', 'blood pressure and the CVD risk profile', 'CVD progression and CVD risk management', 'CVD risk and CVD progression']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0035649', 'cui_str': 'Risk management'}]",300.0,0.0993086,PE independently increases the risk for premature cardiovascular disease (CVD) in mothers and their children long-term.,"[{'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Jääskeläinen', 'Affiliation': 'Medical and Clinical Genetics, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Kivelä', 'Affiliation': 'Medical and Clinical Genetics, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Renlund', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Heinonen', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Aittasalo', 'Affiliation': 'UKK Institute for Health Promotion Research, Tampere, Finland.'}, {'ForeName': 'Hannele', 'Initials': 'H', 'LastName': 'Laivuori', 'Affiliation': 'Medical and Clinical Genetics, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Taisto', 'Initials': 'T', 'LastName': 'Sarkola', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}]",Preventive medicine reports,['10.1016/j.pmedr.2022.101731']
3238,35242892,"Effects of empagliflozin on markers of calcium and phosphate homeostasis in patients with type 2 diabetes - Data from a randomized, placebo-controlled study.","Background and aim


Sodium-glucose cotransporter-2 (SGLT2) inhibitors, glucose-lowering drugs that increase urinary glucose excretion have been shown to reduce CV events in patients with type 2 diabetes (T2D). Furthermore, several studies have demonstrated that treatment with SGLT2 inhibitors affect calcium and phosphate homeostasis, but the effect of empagliflozin on these biomarkers is hitherto not investigated in detail. Therefore, this analysis of the EMPA hemodynamics study examined effects of empagliflozin on calcium and phosphate homeostasis.
Methods


In this placebo-controlled, randomized, double-blind study patients with T2D were randomized to empagliflozin 10 mg (n = 20) or placebo (n = 22). Biomarkers of calcium and phosphate homeostasis were assessed before, and after 3 days and 3 months of treatment.
Results


After 3 days of treatment empagliflozin significantly increased serum levels of phosphate (baseline: 1.10 ± 0.21 mmol/L; day 3: 1.25 ± 0.23 mmol/L; p = 0.036), parathyroid hormone (PTH) (baseline: 57.40 ± 30.49 pg/mL; day 3: 70.23 ± 39.25 pg/mL; p = 0.025), fibroblast growth factor 23 (FGF23) (baseline: 77.92 ± 24.31 pg/mL; day 3: 109.18 ± 58.20 pg/mL; p = 0.001) and decreased 1,25-dihydroxyvitamin D (baseline: 35.01 ± 14.01 ng/L; day 3: 22.09 ± 10.02 mg/L; p < 0.001), while no difference of these parameters was recorded after 3 months of treatment. Empagliflozin had no significant effects on serum calcium and markers of bone resorption (collagen type 1 β-carboxy-telopeptide = β-CTX) or formation (osteocalcin) after 3 days and 3 months of treatment.
Conclusions


Empagliflozin treatment of patients with T2D transiently increases serum phosphate, PTH and FGF23, and decreases 1,25-dihydroxyvitamin D. This might reflect a temporal increase of sodium driven phosphate reabsorption in the proximal tubule of the kidney caused by increased sodium availability in response to SGLT2 inhibition.",2022,"After 3 days of treatment empagliflozin significantly increased serum levels of phosphate (baseline: 1.10 ± 0.21 mmol/L; day 3: 1.25 ± 0.23 mmol/L; p = 0.036), parathyroid hormone (PTH) (baseline: 57.40 ± 30.49 pg/mL; day 3: 70.23 ± 39.25 pg/mL; p = 0.025), fibroblast growth factor 23 (FGF23) (baseline: 77.92 ± 24.31 pg/mL; day 3: 109.18 ± 58.20 pg/mL; p = 0.001) and decreased 1,25-dihydroxyvitamin D (baseline: 35.01 ± 14.01 ng/L; day 3: 22.09 ± 10.02 ","['patients with type 2 diabetes (T2D', 'patients with T2D', 'patients with type 2 diabetes - Data']","['Sodium-glucose cotransporter-2 (SGLT2) inhibitors, glucose-lowering drugs', 'Empagliflozin', 'placebo', 'empagliflozin']","['markers of calcium and phosphate homeostasis', 'serum calcium and markers of bone resorption (collagen type 1 β-carboxy-telopeptide\xa0=\xa0β-CTX) or formation (osteocalcin', 'serum phosphate, PTH and FGF23, and decreases 1,25-dihydroxyvitamin D', 'parathyroid hormone (PTH', 'serum levels of phosphate', 'fibroblast growth factor 23 (FGF23', '1,25-dihydroxyvitamin D']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0370232', 'cui_str': '1,25-dihydroxyvitamin D'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.170786,"After 3 days of treatment empagliflozin significantly increased serum levels of phosphate (baseline: 1.10 ± 0.21 mmol/L; day 3: 1.25 ± 0.23 mmol/L; p = 0.036), parathyroid hormone (PTH) (baseline: 57.40 ± 30.49 pg/mL; day 3: 70.23 ± 39.25 pg/mL; p = 0.025), fibroblast growth factor 23 (FGF23) (baseline: 77.92 ± 24.31 pg/mL; day 3: 109.18 ± 58.20 pg/mL; p = 0.001) and decreased 1,25-dihydroxyvitamin D (baseline: 35.01 ± 14.01 ng/L; day 3: 22.09 ± 10.02 ","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Rau', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Thiele', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Niels-Ulrik Korbinian', 'Initials': 'NK', 'LastName': 'Hartmann', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Möllmann', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wied', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Hohl', 'Affiliation': 'Department of Internal Medicine III, University Hospital Saarland, Saarland University, Homburg/Saar, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lehrke', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}]",Bone reports,['10.1016/j.bonr.2022.101175']
3239,35242807,Application of Operating Room Nursing Intervention to Incision Infection of Patients Undergoing Gastrointestinal Surgery Can Reduce Complications and Improve Gastrointestinal Function.,"Objective


To observe the influence of nursing intervention in operation rooms on incision infection of patients undergoing gastrointestinal surgery and the improvement of gastrointestinal function.
Methods


A total of 340 patients who underwent gastrointestinal surgery in our hospital from June 2020 to August 2021 were included. According to the random number table, they were divided into the conventional nursing group ( n  = 170) and the operating room nursing group ( n  = 170). The conventional nursing group was treated with routine nursing intervention, while the operating room nursing group was treated with operating room nursing intervention. The incision infection, healing, gastrointestinal function recovery, and complications in the two groups were compared, and the patient care satisfaction was recorded.
Results


The incidence of incision swelling, pain, and incision secretion in the operating room nursing group was significantly lower than that in the conventional nursing group ( p  < 0.05). The patients in the operating room nursing group had higher grade A healing than in the conventional nursing group, and lower grade B and grade C healing than in the conventional nursing group ( p  < 0.05). The time of anal exhaust, first defecation, and the time of gastric tube removal in the operating room nursing group were lower than those in the conventional nursing group ( p  < 0.05). The incidence of postoperative complications, such as incision infection, incision dehiscence, early inflammatory bowel adhesion, and abdominal abscess, in the operating room nursing group was lower than that in the conventional nursing group ( p  < 0.05). The total satisfaction degree in the operating room nursing group was significantly higher than that in the conventional nursing group ( p  < 0.05).
Conclusion


Nursing intervention in operation room can reduce complications and improve gastrointestinal function when applied to patients undergoing gastrointestinal surgery due to incision infection.",2022,"The total satisfaction degree in the operating room nursing group was significantly higher than that in the conventional nursing group ( p  < 0.05).
","['patients undergoing gastrointestinal surgery due to incision infection', 'Patients', 'patients undergoing gastrointestinal surgery', '340 patients who underwent gastrointestinal surgery in our hospital from June 2020 to August 2021 were included']","['routine nursing intervention, while the operating room nursing group was treated with operating room nursing intervention', 'Operating Room Nursing Intervention', 'nursing intervention']","['Gastrointestinal Function', 'incidence of postoperative complications, such as incision infection, incision dehiscence, early inflammatory bowel adhesion, and abdominal abscess', 'time of anal exhaust, first defecation, and the time of gastric tube removal', 'incision infection, healing, gastrointestinal function recovery, and complications', 'total satisfaction degree', 'incidence of incision swelling, pain, and incision secretion', 'grade B and grade C healing', 'gastrointestinal function', 'grade A healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0029062', 'cui_str': 'Nursing, Operating Room'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0038940', 'cui_str': 'Dehiscence of surgical wound'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0267778', 'cui_str': 'Adhesion of intestine'}, {'cui': 'C0243001', 'cui_str': 'Abdominal abscess'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0441806', 'cui_str': 'Grade B'}, {'cui': 'C0441807', 'cui_str': 'Grade C'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}]",340.0,0.0258058,"The total satisfaction degree in the operating room nursing group was significantly higher than that in the conventional nursing group ( p  < 0.05).
","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Operating Room, The First People's Hospital of Lianyungang, Lianyungang, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Operating Room, The First People's Hospital of Lianyungang, Lianyungang, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': ""Operating Room, The First People's Hospital of Lianyungang, Lianyungang, China.""}]",Frontiers in surgery,['10.3389/fsurg.2022.842309']
3240,35242806,Clinical Efficacy of Different Thoracoscopic Surgeries for Patients With Non-small Cell Lung Cancer.,"Background


The aim of this study was to analyze the clinical efficacy of different thoracoscopic procedures in patients with non-small cell lung cancer and their correlation with matrix metalloproteinase-7 mRNA (MMPs-7 mRNA) and soluble major histocompatibility complex class I molecule A (sMICA), as well as their effect on T-cell subsets.
Methods


A total of 100 patients with non-small cell lung cancer who received different thoracoscopic surgeries were divided into the Control group (three-port thoracoscopic surgery) and the study group (single-port thoracoscopic surgery). The two groups were evaluated to compare the perioperative indicators, MMPs-7 mRNA, sMICA expression levels, T-cell subsets, postoperative pain, complication rates, and prognostic outcomes at 1-year follow-up.
Results


The operation time, blood loss, drainage tube placement time, incision length, and hospital stay in the study group were less than those in the control group ( P  < 0.05). There was no significant difference in the number of lymph node dissections between the two groups ( P  > 0.05). After 3 days, the expression levels of MMPs-7 mRNA and sMICA in the study group were lower than those in the control group ( P  < 0.05); CD4 +, CD8 +, and CD4 +/CD8 + in the study group were higher than those in the control group ( P  < 0.05). On days 1, 3, and 5, the visual analog score (VAS) of the study group was lower than that of the control group ( P  < 0.05); there was no significant difference in the complication rate between the two follow-up groups ( P  > 0.05), in which all patients completed the follow-up. After 1 year of follow-up, there was no significant difference in the tumor-free survival rate and overall survival rate between the two groups ( P  > 0.05).
Conclusion


Compared with three-port thoracoscopic surgery, single-port thoracoscopic surgery can improve perioperative expression, shorten hospital stay, reduce serum tumor micrometastasis levels, improve immune metastasis mechanisms and reduce pain, which is of great significance to patients with non-small cell lung cancer. It is an effective, convenient, and safe surgical option that deserves wide clinical reference.",2022,"After 1 year of follow-up, there was no significant difference in the tumor-free survival rate and overall survival rate between the two groups ( P  > 0.05).
","['patients with non-small cell lung cancer and their correlation with matrix metalloproteinase-7 mRNA (MMPs-7 mRNA) and soluble major histocompatibility complex class I molecule A', '100 patients with non-small cell lung cancer who received different thoracoscopic surgeries', 'Patients With Non-small Cell Lung Cancer', 'patients with non-small cell lung cancer']","['Control group (three-port thoracoscopic surgery) and the study group (single-port thoracoscopic surgery', 'thoracoscopic procedures', 'Thoracoscopic Surgeries', 'three-port thoracoscopic surgery, single-port thoracoscopic surgery']","['perioperative indicators, MMPs-7 mRNA, sMICA expression levels, T-cell subsets, postoperative pain, complication rates, and prognostic outcomes at 1-year follow-up', 'number of lymph node dissections', 'complication rate', 'CD4 +, CD8 +, and CD4 +/CD8 ', 'visual analog score (VAS', 'tumor-free survival rate and overall survival rate', 'clinical efficacy', 'operation time, blood loss, drainage tube placement time, incision length, and hospital stay', 'perioperative expression, shorten hospital stay, reduce serum tumor micrometastasis levels, improve immune metastasis mechanisms and reduce pain', 'expression levels of MMPs-7 mRNA and sMICA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0166059', 'cui_str': 'Matrilysin'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1440752', 'cui_str': 'Major histocompatibility complex class I'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C2316808', 'cui_str': 'Thoracoscopic procedure'}]","[{'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0166059', 'cui_str': 'Matrilysin'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C1440752', 'cui_str': 'Major histocompatibility complex class I'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080202', 'cui_str': 'T-Cell Subsets'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1513276', 'cui_str': 'Micrometastases, Neoplasm'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",100.0,0.185388,"After 1 year of follow-up, there was no significant difference in the tumor-free survival rate and overall survival rate between the two groups ( P  > 0.05).
","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, The First Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, The First Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, The First Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liang', 'Affiliation': 'Department of Thoracic Surgery, The First Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xiaokuang', 'Initials': 'X', 'LastName': 'Ning', 'Affiliation': 'Department of Thoracic Surgery, The First Medical Center of PLA General Hospital, Beijing, China.'}]",Frontiers in surgery,['10.3389/fsurg.2022.842047']
3241,35242805,"Effects of Transient Electrical Acupuncture Stimulation Combined With Rehabilitation Training on Hemorheology, Neurological Function and BDNF in Patients With Cerebral Infarction.","Objective


To explore the effects of transient electric acupuncture stimulation combined with rehabilitation training on hemorheology, neurological function and brain-derived neurotrophic factor (BDNF) in patients with cerebral infarction (CI).
Methods


A total of 90 patients with CI were admitted to our hospital from March 2019 to March 2021. According to the random number table method, 90 patients were divided into a control group (was treated with transient electrical acupuncture stimulation intervention treatment) and a therapy group (was treated with rehabilitation training on the basis of the control group), with 45 cases in each group. NIHSS score to detect neurological deficit; FMA score to detect motor function recovery; the clinical efficacy of the two groups of patients were compared; blood rheology analyzer to detect whole blood high shear viscosity, whole blood low shear viscosity, platelet aggregation rate and fibrinogen indicators; ELISA detects the content of BDNF in serum.
Results


There was no significant difference in NIHSS score, FMA score, clinical efficacy, hemorheology index, and BDNF content between the two groups of patients before treatment ( P  > 0.05). After treatment, the NIHSS score, whole blood high shear visible, whole blood low shear visible, platelet aggregation rate and fibrinogen index of the two groups were lower than those before treatment, and the FMA score and BDNF content of the two groups were higher than those before treatment, and all the above indicators in the therapy group changed significantly compared with the control group ( P  < 0.05). After treatment, the clinical efficacy of the therapy group was better than that of the control group ( P  < 0.05).
Conclusion


The combination of transient electrical acupuncture stimulation and rehabilitation training can inhibit the blood flow index of patients with CI, improve the nerve function, increase the content of BDNF in the patient's serum, and restore the patient's nerve function.",2022,"After treatment, the NIHSS score, whole blood high shear visible, whole blood low shear visible, platelet aggregation rate and fibrinogen index of the two groups were lower than those before treatment, and the FMA score and BDNF content of the two groups were higher than those before treatment, and all the above indicators in the therapy group changed significantly compared with the control group ( P  < 0.05).","['patients with cerebral infarction (CI', 'patients with CI', '90 patients with CI were admitted to our hospital from March 2019 to March 2021', 'Patients With Cerebral Infarction']","['transient electrical acupuncture stimulation intervention treatment) and a therapy group (was treated with rehabilitation training', 'Transient Electrical Acupuncture Stimulation Combined With Rehabilitation Training', 'transient electric acupuncture stimulation combined with rehabilitation training', 'transient electrical acupuncture stimulation and rehabilitation training']","['Hemorheology, Neurological Function and BDNF', 'NIHSS score, whole blood high shear visible, whole blood low shear visible, platelet aggregation rate and fibrinogen index', 'blood flow index', 'hemorheology, neurological function and brain-derived neurotrophic factor (BDNF', 'NIHSS score', 'NIHSS score, FMA score, clinical efficacy, hemorheology index, and BDNF content', 'clinical efficacy', 'FMA score and BDNF content']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0206502', 'cui_str': 'Hemorrheology'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",90.0,0.0105981,"After treatment, the NIHSS score, whole blood high shear visible, whole blood low shear visible, platelet aggregation rate and fibrinogen index of the two groups were lower than those before treatment, and the FMA score and BDNF content of the two groups were higher than those before treatment, and all the above indicators in the therapy group changed significantly compared with the control group ( P  < 0.05).","[{'ForeName': 'Shuangqin', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital, Department of Neurology, Hengyang Medical School, University of South China, Hengyang, China.'}, {'ForeName': 'Jianghua', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'The First Affiliated Hospital, Department of Neurology, Hengyang Medical School, University of South China, Hengyang, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'The First Affiliated Hospital, Department of Neurology, Hengyang Medical School, University of South China, Hengyang, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital, Department of Rehabilitation, Hengyang Medical School, University of South China, Hengyang, China.'}, {'ForeName': 'Yahua', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'The First Affiliated Hospital, Department of Rehabilitation, Hengyang Medical School, University of South China, Hengyang, China.'}]",Frontiers in surgery,['10.3389/fsurg.2022.839523']
3242,35242803,Ultrasound-Guided Block of the Internal Branch of the Superior Laryngeal Nerve Reduces Postoperative Sore Throat Caused by Suspension Laryngoscopic Surgery: A Prospective Randomized Trial.,"Objective


Suspension laryngoscopy is commonly used in operative laryngology. Although it is efficient and minimally invasive in most cases, it can lead to postoperative sore throat (POST) and cough. Because of intensive stimulation by the rigid metal suspension laryngoscope, procedures must be implemented under general anesthesia. Together, these factors increase the possibility of postoperative complications. Blocking the internal branch of the superior laryngeal nerve (SLN) is useful in inhibiting the endotracheal intubation stress response. Thus, we evaluated the efficacy of ultrasound-guided block of the internal branches of the superior laryngeal nerve to improve postoperative complications.
Methods


A total of 64 patients was scheduled for elective laryngeal cancer resection, and suspension laryngoscopic surgery was performed under general anesthesia with a block of the internal branch of the superior laryngeal nerve (group iSLNB,  n  = 32) and without a block (group C,  n  = 32). Patients in group iSLNB received ultrasound-guided blocks of the internal branches of superior laryngeal nerve bilaterally (0.2% ropivacaine, 2 ml each side). The primary outcome measures were the incidence and severity of sore throat and cough assessed 0.5, 2, 6, and 24 h after tracheal extubation. The secondary outcome measures were heart rate and mean arterial pressure on arrival in the operating room (T0), at endotracheal intubation (T1), upon insertion of the suspension laryngoscope (T2), 5 min after insertion (T3), at tracheal extubation (T4), and 5 min after extubation (T5). Blood glucose levels were measured at T0, T3, and T5.
Results


The incidence and severity of POST and cough in the iSLNB (internal branch of superior laryngeal nerve block) group were significantly reduced within 6 h after extubation compared with those in the control group, regardless of whether swallowing was present ( P  < 0.05). Compared to the control group from T0-T5, except at T0, the iSLNB group had significantly lower heart rate and mean arterial pressure ( P  < 0.05). Compared to T0, at other time points, the heart rates in the control group were significantly increased ( P  < 0.05), and the mean arterial pressures at other time points in the iSLNB group were significantly lower than those at T0 ( P  < 0.05). The blood glucose levels at T3 and T5 in the iSLNB group were significantly reduced compared with those in the control group ( P  < 0.05).
Conclusion


Ultrasound-guided block of the internal branch of the superior laryngeal nerve might effectively ameliorate postoperative complications secondary to suspension laryngoscopic surgery with endotracheal intubation under general anesthesia and improve hemodynamic stability.
Clinical Trial Registration


https://www.chictr.org.cn, identifier: ChiCTR2100049801.",2022,Blocking the internal branch of the superior laryngeal nerve (SLN) is useful in inhibiting the endotracheal intubation stress response.,"['64 patients was scheduled for elective laryngeal cancer resection, and']","['Ultrasound-Guided Block of the Internal Branch of the Superior Laryngeal Nerve Reduces Postoperative Sore Throat Caused by Suspension Laryngoscopic Surgery', 'suspension laryngoscopic surgery with endotracheal intubation', 'superior laryngeal nerve (SLN', 'suspension laryngoscopic surgery was performed under general anesthesia with a block of the internal branch of the superior laryngeal nerve (group iSLNB,  n  = 32) and without a block', 'Suspension laryngoscopy', 'ultrasound-guided blocks of the internal branches of superior laryngeal nerve bilaterally (0.2% ropivacaine']","['blood glucose levels', 'mean arterial pressures', 'Blood glucose levels', 'possibility of postoperative complications', 'incidence and severity of sore throat and cough assessed 0.5, 2, 6, and 24 h after tracheal extubation', 'heart rate and mean arterial pressure', 'incidence and severity of POST and cough in the iSLNB (internal branch of superior laryngeal nerve block', 'heart rate and mean arterial pressure on arrival in the operating room (T0), at endotracheal intubation (T1), upon insertion of the suspension laryngoscope (T2), 5 min after insertion (T3), at tracheal extubation (T4), and 5 min after extubation (T5', 'heart rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0007107', 'cui_str': 'Malignant tumor of larynx'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0751260', 'cui_str': 'Surgical Procedures, Laryngoscopic'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0394817', 'cui_str': 'Local anesthetic superior laryngeal nerve block'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0439232', 'cui_str': 'min'}]",64.0,0.0392345,Blocking the internal branch of the superior laryngeal nerve (SLN) is useful in inhibiting the endotracheal intubation stress response.,"[{'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'Department of Anesthesiology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': 'Department of Anesthesiology, Shenzhen University General Hospital, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Otolaryngology Head and Neck Surgery (Ministry of Education of China), Department of Otolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhong', 'Affiliation': 'Key Laboratory of Otolaryngology Head and Neck Surgery (Ministry of Education of China), Department of Otolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Guyan', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}]",Frontiers in surgery,['10.3389/fsurg.2022.829811']
3243,35242798,A Nutrient Formulation Affects Developmental Myelination in Term Infants: A Randomized Clinical Trial.,"Background and Objectives


Observational studies suggest differences between breast-fed and formula-fed infants in developmental myelination, a key brain process for learning. The study aims to investigate the efficacy of a blend of docosahexaenoic acid (DHA), arachidonic acid (ARA), iron, vitamin B12, folic acid, and sphingomyelin (SM) from a uniquely processed whey protein concentrate enriched in alpha-lactalbumin and phospholipids compared with a control formulation on myelination, cognitive, and behavioral development in the first 6 months of life.
Methods


These are 6-month results from an ongoing two-center, randomized controlled trial with a 12-month intervention period (completed for all participants). In this study, full term, neurotypical infants of both sexes ( N  = 81) were randomized into investigational ( N  = 42) or control groups ( N  = 39). In addition, non-randomized breast-fed children ( N  = 108) serve as a natural reference group. Main outcomes are myelination (MRI), cognitive (Bayley Scales of Infant and Toddler Development, 3rd edition [Bayley-III]), social-emotional development (Ages and Stages Questionnaires: Social-Emotional, 2nd edition [ASQ:SE-2]), sleep (Brief Infant Sleep Questionnaire [BISQ]), and safety (growth and adverse events [AEs]).
Results


The full analyses set comprises  N  = 66 infants. Significant differences in myelin structure, volume, and rate of myelination were observed in favor of the investigational myelin blend at 3 and 6 months of life. Effects were demonstrated for whole brain myelin and for cerebellar, parietal, occipital, and temporal regions, known to be functionally involved in sensory, motor, and language skills. No statistically significant differences were found for early behavior and cognition scores.
Conclusions


This is the first study demonstrating the efficacy of a myelin nutrient blend in well-nourished, term infants on developmental myelination, which may be foundational for later cognitive and learning outcomes.
Clinical Trial Registration


ClinicalTrials.gov, identifier: NCT03111927.",2022,"No statistically significant differences were found for early behavior and cognition scores.
","['neurotypical infants of both sexes ( N  = 81', 'Term Infants']","['docosahexaenoic acid (DHA), arachidonic acid (ARA), iron, vitamin B12, folic acid, and sphingomyelin (SM']","['myelination, cognitive, and behavioral development', 'myelin structure, volume, and rate of myelination', 'early behavior and cognition scores', 'myelination (MRI), cognitive (Bayley Scales of Infant and Toddler Development, 3rd edition [Bayley-III]), social-emotional development (Ages and Stages Questionnaires: Social-Emotional, 2nd edition [ASQ:SE-2]), sleep (Brief Infant Sleep Questionnaire [BISQ]), and safety (growth and adverse events [AEs', 'whole brain myelin and for cerebellar, parietal, occipital, and temporal regions, known to be functionally involved in sensory, motor, and language skills']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0037906', 'cui_str': 'Sphingomyelin'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0026969', 'cui_str': 'Myelin'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0023008', 'cui_str': 'Language'}]",81.0,0.264576,"No statistically significant differences were found for early behavior and cognition scores.
","[{'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Schneider', 'Affiliation': 'Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Muriel M K', 'Initials': 'MMK', 'LastName': 'Bruchhage', 'Affiliation': 'Department of Pediatrics, Brown University, Providence, RI, United States.'}, {'ForeName': 'Barry V', 'Initials': 'BV', 'LastName': ""O'Neill"", 'Affiliation': 'Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Mickaël', 'Initials': 'M', 'LastName': 'Hartweg', 'Affiliation': 'Clinical Research Unit, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Tanguy', 'Affiliation': 'Clinical Research Unit, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Steiner', 'Affiliation': 'Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé SA, Lausanne, Switzerland.'}, {'ForeName': 'Gisella', 'Initials': 'G', 'LastName': 'Mutungi', 'Affiliation': 'Nestlé Nutrition, Société des Produits Nestlé SA, Vevey, Switzerland.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': ""O'Regan"", 'Affiliation': 'Nestlé Development Centre Nutrition, Askeaton, Ireland.'}, {'ForeName': 'Séamus', 'Initials': 'S', 'LastName': 'Mcsweeney', 'Affiliation': 'Nestlé Development Centre Nutrition, Askeaton, Ireland.'}, {'ForeName': 'Viren', 'Initials': 'V', 'LastName': ""D'Sa"", 'Affiliation': 'Department of Pediatrics, Brown University, Providence, RI, United States.'}, {'ForeName': 'Sean C L', 'Initials': 'SCL', 'LastName': 'Deoni', 'Affiliation': 'Department of Pediatrics, Brown University, Providence, RI, United States.'}]",Frontiers in nutrition,['10.3389/fnut.2022.823893']
3244,35243125,Evaluation of short-term effects of three passive aquatic interventions on chronic non-specific low back pain: Study protocol for a randomized cross-over clinical trial.,"Background


Low back pain (LBP) is among the most common physical ailments and its chronic manifestation is a leading cause for disability worldwide. LBP is not attributable to a known diagnosis in 85% of the cases and therefore called chronic non-specific LBP (cnLBP). Passive immersion in warm water is commonly claimed to reduce muscular tension and pain, but not yet sufficiently investigated with regard to cnLBP. The current study compares three passive aquatic interventions regarding their effects on cnLBP: floating (resting in a supine immersed position on flotation devices), WATSU (a passive hands-on treatment, in which a practitioner stands in warm water, gently moving and massaging the client), and a Spa session.
Methods


In this randomized cross-over clinical trial, all 24 adult participants with cnLBP will undergo the three interventions in balanced order with a washout-period of at least two weeks in between. Assessments will take place at baseline and follow-up of study and immediately before and after each intervention. Assessments cover the primary outcome self-reported current pain (Visual Analog Scale, range: 0-100 mm), other self-report questionnaires (addressing, e.g., personality traits or -states), and physiological parameters (e.g., measurement of spinal range of motion).
Discussion


The study adds estimates of intervention-specific effect-sizes of widespread passive aquatic interventions to cnLBP. The study also points to potential underlying pain-reducing mechanisms.
Trial registration


The protocol was approved by the Ethics Committee of the Canton Bern (ProjectID: 2018-00461). Trial registration is intended at ClinicalTrials.gov.",2022,LBP is not attributable to a known diagnosis in 85% of the cases and therefore called chronic non-specific LBP (cnLBP).,"['chronic non-specific low back pain', '24 adult participants with cnLBP']","['LBP', 'passive aquatic interventions']","['muscular tension and pain', 'current pain (Visual Analog Scale, range: 0-100\xa0mm), other self-report questionnaires (addressing, e.g., personality traits or -states), and physiological parameters (e.g., measurement of spinal range of motion']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0233849', 'cui_str': 'Character trait finding'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",24.0,0.276701,LBP is not attributable to a known diagnosis in 85% of the cases and therefore called chronic non-specific LBP (cnLBP).,"[{'ForeName': 'Agnes M', 'Initials': 'AM', 'LastName': 'Schitter', 'Affiliation': 'Bern University of Applied Sciences, Department of Health Professions, Physiotherapy, Murtenstrasse 10, CH - 3008 Bern, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Frei', 'Affiliation': 'University of Hildesheim, Institute of Sport Science, Universitätsplatz 1, DE - 31141 Hildesheim, Germany.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Elfering', 'Affiliation': 'University of Bern, Institute of Psychology, Fabrikstrasse 8, CH - 3012 Bern, Switzerland.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Kurpiers', 'Affiliation': 'University of Hildesheim, Institute of Sport Science, Universitätsplatz 1, DE - 31141 Hildesheim, Germany.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Radlinger', 'Affiliation': 'Bern University of Applied Sciences, Department of Health Professions, Physiotherapy, Murtenstrasse 10, CH - 3008 Bern, Switzerland.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2022.100904']
3245,35243123,Does a gluten-free diet lead to better glycemic control in children with type 1 diabetes? Results from a feasibility study and recommendations for future trials.,"Background


Increasing evidence suggests a link between type 1 diabetes (T1D) and intake of gluten, but no controlled trials have examined whether a gluten-free diet (GFD) has positive effects on glycemic control in children with T1D.
Methods


We conducted a non-randomized feasibility study. Twenty-three children with newly diagnosed T1D were included and either followed a GFD (n = 14) or a normal diet (n = 9) for 12 months. Effects of diet on glycemic control were examined by measuring insulin production (c-peptide), hemoglobine A1c (HbA1c) and insulin dose adjusted A1c (IDAA1c). Degree of adherence to the GFD and effects on quality of life were also examined.
Results


Children on a GFD showed a statistically significantly lower HbA1c at six months (P = 0.042) compared with children on a normal diet and point estimate differences indicated better glycemic control in the GFD group at 6 and 12 months. Adherence to a GFD varied but was satisfactory for a majority of children. The GFD group reported poorer quality of life at inclusion and there was a non-significant difference for quality of life between groups throughout the study.
Conclusions


A strict GFD can be maintained by children with newly diagnosed T1D and may have positive effects on glycemic control. Our findings should be interpreted carefully because of small samples and possible confounding. We provide recommendations for future trials and suggest using a randomized-controlled design with 30-40 participants in each arm.",2022,"The GFD group reported poorer quality of life at inclusion and there was a non-significant difference for quality of life between groups throughout the study.
","['Twenty-three children with newly diagnosed T1D', '30-40 participants in each arm', 'children with T1D.\nMethods', 'children with type 1 diabetes']",['normal diet'],"['insulin production (c-peptide), hemoglobine A1c (HbA1c) and insulin dose adjusted A1c (IDAA1c', 'quality of life', 'glycemic control']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0184625', 'cui_str': 'Normal diet'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",23.0,0.0429088,"The GFD group reported poorer quality of life at inclusion and there was a non-significant difference for quality of life between groups throughout the study.
","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Söderström', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Skåne University Hospital Lund, Lund University, Lund, Sweden.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Cervin', 'Affiliation': 'Department of Clinical Sciences, Child and Adolescent Psychiatry, Lund University, Lund, Sweden.'}, {'ForeName': 'Jonatan', 'Initials': 'J', 'LastName': 'Dereke', 'Affiliation': 'Department of Clinical Sciences, Diabetes Research Laboratory, Lund University, Lund, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Hillman', 'Affiliation': 'Department of Health Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Iren', 'Initials': 'I', 'LastName': 'Tiberg', 'Affiliation': 'Department of Health Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Norström', 'Affiliation': 'Department of Epidemiology and Global Health, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Annelie', 'Initials': 'A', 'LastName': 'Carlsson', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Skåne University Hospital Lund, Lund University, Lund, Sweden.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2022.100893']
3246,35243112,Diagnostic performance of volumetric laser endomicroscopy for Barrett's esophagus dysplasia amongst gastroenterology trainees.,"Background


Volumetric laser endomicroscopy (VLE) is an advanced imaging modality used in Barrett's esophagus (BE) surveillance. VLE image interpretation is challenged by subtle grayscale image variation across a large amount of data. Training in VLE interpretation is not standardized. This study aims to determine if VLE training can be incorporated into a gastroenterology (GI) fellowship curriculum with the use of a self-directed module.
Methods


A standardized, self-directed training module (30 min) was created explaining the background and established VLE criteria for the diagnosis of BE dysplasia. A VLE image dataset was generated from a multicenter VLE database of targeted biopsies. GI trainees were asked to grade each image for the presence or absence of the following criteria (I) increased surface optical frequency domain imaging (OFDI) signal intensity and (II) atypical glands and provide a final diagnosis (dysplastic  vs.  non-dysplastic). Diagnostic performance was calculated and results compared to VLE expert interpretation using histology as the gold-standard.
Results


The dataset included 50 VLE images (10 high-grade dysplasia, 40 non-dysplastic BE). VLE images were reviewed in a randomized and blinded fashion by 5 GI trainees with no prior VLE experience and 5 experienced VLE users. Sensitivity, specificity and accuracy of GI trainees was 83.3% (95% CI: 71.5-91.7%), 59.0% (95% CI: 51.6-66.0%), and 64.8% (95% CI: 58.5-70.7%) compared to 80.0% (95% CI: 67.7-89.2%), 79.5% (95% CI: 73.0-85.0%), and 79.6% (95% CI: 74.1-84.4%) for VLE experts respectively. The difference in specificity and accuracy between the two groups were statistically significant with P<0.001.
Conclusions


A brief training session on VLE is inadequate to reach competency in interpretation of VLE by GI trainees. Additional experience is required to accurately interpret VLE images.",2022,"Sensitivity, specificity and accuracy of GI trainees was 83.3% (95% CI: 71.5-91.7%), 59.0% (95% CI: 51.6-66.0%), and 64.8% (95% CI: 58.5-70.7%) compared to 80.0% (95% CI: 67.7-89.2%), 79.5% (95% CI: 73.0-85.0%), and 79.6% (95% CI: 74.1-84.4%) for VLE experts respectively.","[""Barrett's esophagus dysplasia amongst gastroenterology trainees"", '5 GI trainees with no prior VLE experience and 5 experienced VLE users']","['\n\n\nVolumetric laser endomicroscopy (VLE', 'volumetric laser endomicroscopy', 'VLE training']","['specificity and accuracy', 'Diagnostic performance', 'surface optical frequency domain imaging (OFDI) signal intensity and (II) atypical glands', 'Sensitivity, specificity and accuracy of GI trainees']","[{'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C4682863', 'cui_str': 'Volumetric laser endomicroscopy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C4682863', 'cui_str': 'Volumetric laser endomicroscopy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C4682863', 'cui_str': 'Volumetric laser endomicroscopy'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C1285092', 'cui_str': 'Gland structure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.213393,"Sensitivity, specificity and accuracy of GI trainees was 83.3% (95% CI: 71.5-91.7%), 59.0% (95% CI: 51.6-66.0%), and 64.8% (95% CI: 58.5-70.7%) compared to 80.0% (95% CI: 67.7-89.2%), 79.5% (95% CI: 73.0-85.0%), and 79.6% (95% CI: 74.1-84.4%) for VLE experts respectively.","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Aziz', 'Affiliation': 'Department of Internal Medicine, University of Toledo Medical Center, Toledo, OH, USA.'}, {'ForeName': 'Chandra S', 'Initials': 'CS', 'LastName': 'Dasari', 'Affiliation': 'Gastroenterology and Hepatology, Veterans Affair Medical Center, Kansas City, MO, USA.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Rai', 'Affiliation': 'Gastroenterology and Hepatology, Veterans Affair Medical Center, Kansas City, MO, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Alsop', 'Affiliation': 'Gastroenterology and Hepatology, Veterans Affair Medical Center, Kansas City, MO, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Gastroenterology, Loyola University, Chicago, IL, USA.'}, {'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Vennalaganti', 'Affiliation': 'Gastroenterology and Hepatology, Veterans Affair Medical Center, Kansas City, MO, USA.'}, {'ForeName': 'Viveksandeep Thoguluva', 'Initials': 'VT', 'LastName': 'Chandrasekar', 'Affiliation': 'Gastroenterology and Hepatology, Veterans Affair Medical Center, Kansas City, MO, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Able', 'Affiliation': 'Gastroenterology and Hepatology, Veterans Affair Medical Center, Kansas City, MO, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kennedy', 'Affiliation': 'Gastroenterology and Hepatology, Veterans Affair Medical Center, Kansas City, MO, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Wallace', 'Affiliation': 'Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Kenneth K', 'Initials': 'KK', 'LastName': 'Wang', 'Affiliation': 'Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Herbert C', 'Initials': 'HC', 'LastName': 'Wolfsen', 'Affiliation': 'Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Gastroenterology and Hepatology, Veterans Affair Medical Center, Kansas City, MO, USA.'}, {'ForeName': 'Cadman L', 'Initials': 'CL', 'LastName': 'Leggett', 'Affiliation': 'Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}]",Translational gastroenterology and hepatology,['10.21037/tgh.2020.02.15']
3247,35243098,Intravenous iron sucrose vs. blood transfusion in the management of moderate postpartum iron deficiency anemia: A non-randomized quasi-experimental study.,"Introduction


Postpartum anemia is often over-treated with blood transfusion without clear indication despite having a potential alternative of parenteral iron therapy. The present study aimed to compare the efficacy of intravenous (IV) iron sucrose with blood transfusion in increasing the hematological parameters in postpartum women with moderate anemia.
Methods


This prospective non-randomized quasi-experimental study was conducted among 44 hemodynamically stable postpartum women with moderate anemia (Hb 7-8 g/dl) in the Obstetrics department of Dhaka Medical College Hospital (DMCH) from January to June 2021. Among them, 22 patients received 600 mg of IV iron sucrose after 48 h of delivery for three subsequent days and the other 22 patients received two units of blood transfusion after 48 h of delivery in two subsequent days. The primary endpoint was increase in Hemoglobin (Hb) and serum ferritin level after 6 weeks of the intervention. Two-way repeated measures ANOVA (mixed factor ANOVA) was applied to compare between before and after effect in the two intervention groups.
Results


Baseline Hb and ferritin were 7.4 g/dl and 73.5 μg/l in IV iron group and 7.3 g/dl and 73.2 μg/l in blood transfusion group. Mean Hb level was increased 4.2 g/dl in IV iron sucrose group and 4.5 g/dl in blood transfusion group at sixth week. Besides, serum ferritin level was increased 40.5 μg/l and 44.8 μg/l after six weeks in IV iron sucrose group and blood transfusion group respectively. Other hematological parameters like reticulocyte count, MCV, MCH, and MCHC also increased significantly after intervention in both groups. However, no significant difference was noticed in the change of hematological parameters in between the groups.
Conclusions


The IV iron sucrose is as effective as blood transfusion in replenishing the hemoglobin and iron storage status in hemodynamically stable women with moderate post-partum anemia. This could be an effective alternative of blood transfusion in treating these patients, especially in resource-poor settings.",2022,"Other hematological parameters like reticulocyte count, MCV, MCH, and MCHC also increased significantly after intervention in both groups.","['postpartum women with moderate anemia', 'hemodynamically stable women with moderate post-partum anemia', 'moderate postpartum iron deficiency anemia', '44 hemodynamically stable postpartum women with moderate anemia (Hb 7-8 g/dl) in the Obstetrics department of Dhaka Medical College Hospital (DMCH) from January to June 2021']","['intravenous (IV) iron sucrose with blood transfusion', 'Intravenous iron sucrose vs. blood transfusion', 'IV iron sucrose']","['serum ferritin level', 'Baseline Hb and ferritin', 'change of hematological parameters', 'Mean Hb level', 'hematological parameters like reticulocyte count, MCV, MCH, and MCHC', 'Hemoglobin (Hb) and serum ferritin level']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C0028775', 'cui_str': 'Obstetrics department'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0060241', 'cui_str': 'iron sucrose'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]","[{'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0206161', 'cui_str': 'Reticulocyte count'}, {'cui': 'C0026394', 'cui_str': 'Molluscum contagiosum virus'}, {'cui': 'C0369183', 'cui_str': 'Mean corpuscular hemoglobin determination'}, {'cui': 'C0474535', 'cui_str': 'Mean corpuscular hemoglobin concentration determination'}]",44.0,0.012807,"Other hematological parameters like reticulocyte count, MCV, MCH, and MCHC also increased significantly after intervention in both groups.","[{'ForeName': 'Rehana Arjuman', 'Initials': 'RA', 'LastName': 'Hye', 'Affiliation': 'Department of Obstetrics and Gynecology, Universal Medical College Hospital, Dhaka, Bangladesh.'}, {'ForeName': 'Nur', 'Initials': 'N', 'LastName': 'Sayeeda', 'Affiliation': 'Department of Obstetrics and Gynecology, Dhaka Medical College Hospital, Dhaka, Bangladesh.'}, {'ForeName': 'G M Raihanul', 'Initials': 'GMR', 'LastName': 'Islam', 'Affiliation': 'Dhaka Medical College Hospital, India.'}, {'ForeName': 'Jannatul Farjana', 'Initials': 'JF', 'LastName': 'Mitu', 'Affiliation': 'Pi Research and Consultancy Center, Dhaka, Bangladesh.'}, {'ForeName': 'Mir Susmita', 'Initials': 'MS', 'LastName': 'Zaman', 'Affiliation': 'Pi Research and Consultancy Center, Dhaka, Bangladesh.'}]",Heliyon,['10.1016/j.heliyon.2022.e08980']
3248,35243022,S tereotactic Ablative Radiotherapy for oligo-progressive disease refractory to systemic therapy in Non-Small Cell Lung Cancer: A registry-based phase II randomized trial (SUPPRESS-NSCLC).,"Background


Management of Non-Small Cell Lung Cancer (NSCLC) patients with oligoprogression remains controversial. There is limited data to support the strategy of Stereotactic Ablative Radiotherapy (SABR) targeting the oligoprogressive disease in combination with ongoing systemic treatment. We aim to assess the benefit of this approach compared to standard of care in the treatment of oligoprogressive NSCLC.
Methods


This phase II study will enroll 68 patients with oligoprogressive NSCLC, defined as 1-5 progressive extracranial lesions ≤5 cm involving ≤3 organs. Patients on active systemic therapy (chemotherapy, immunotherapy, targeted therapy or a combination) will be randomized 1:1 to either continue their current systemic therapy in combination with SABR to all lesions or the standard of care (switch to the next line of treatment, continue same treatment or observation). The co-primary endpoints are progression-free survival (PFS) and overall survival (OS). Secondary endpoints include time to next systemic treatment, patient-reported quality of life, cost effectiveness as well as translational analysis to characterize both adaptive immunity and immunogenic cell death markers in the peripheral blood.
Discussion


There is an unmet need to carefully examine the efficacy, safety and quality of life impact of SABR in the context of oligoprogressive disease. The present study will provide higher level randomized evidence on the role of SABR in oligoprogressive NSCLC.",2022,The co-primary endpoints are progression-free survival (PFS) and overall survival (OS).,"['Non-Small Cell Lung Cancer', 'Non-Small Cell Lung Cancer (NSCLC) patients with oligoprogression remains controversial', '68 patients with oligoprogressive NSCLC, defined as 1-5 progressive extracranial lesions ≤5\xa0cm involving ≤3 organs']","['active systemic therapy (chemotherapy, immunotherapy, targeted therapy or a combination', 'S tereotactic Ablative Radiotherapy', 'Stereotactic Ablative Radiotherapy (SABR']","['time to next systemic treatment, patient-reported quality of life, cost effectiveness as well as translational analysis to characterize both adaptive immunity and immunogenic cell death markers in the peripheral blood', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0580586', 'cui_str': 'Extracranial'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0678209', 'cui_str': 'Adoptive immunity'}, {'cui': 'C5197878', 'cui_str': 'Immunogenic Cell Death'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",68.0,0.242669,The co-primary endpoints are progression-free survival (PFS) and overall survival (OS).,"[{'ForeName': 'Houda', 'Initials': 'H', 'LastName': 'Bahig', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, 1051, Rue Sanguinet, H2X 3E4 Montreal, Quebec, Canada.""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Tonneau', 'Affiliation': ""Centre de Recherche Du Centre Hospitalier de L'Université de Montréal (CRCHUM), 900, Rue Saint-Denis, Pavillon R, H2X 0A9 Montreal, Quebec, Canada.""}, {'ForeName': 'Normand', 'Initials': 'N', 'LastName': 'Blais', 'Affiliation': ""Department of Hematology-Oncology, Centre Hospitalier de l'Université de Montréal, 1051, Rue Sanguinet, H2X 3E4 Montreal, Quebec, Canada.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, 1051, Rue Sanguinet, H2X 3E4 Montreal, Quebec, Canada.""}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Filion', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, 1051, Rue Sanguinet, H2X 3E4 Montreal, Quebec, Canada.""}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Campeau', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, 1051, Rue Sanguinet, H2X 3E4 Montreal, Quebec, Canada.""}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Vu', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, 1051, Rue Sanguinet, H2X 3E4 Montreal, Quebec, Canada.""}, {'ForeName': 'Afnan', 'Initials': 'A', 'LastName': 'Al-Saleh', 'Affiliation': ""Centre de Recherche Du Centre Hospitalier de L'Université de Montréal (CRCHUM), 900, Rue Saint-Denis, Pavillon R, H2X 0A9 Montreal, Quebec, Canada.""}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Tehfé', 'Affiliation': ""Department of Hematology-Oncology, Centre Hospitalier de l'Université de Montréal, 1051, Rue Sanguinet, H2X 3E4 Montreal, Quebec, Canada.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Florescu', 'Affiliation': ""Department of Hematology-Oncology, Centre Hospitalier de l'Université de Montréal, 1051, Rue Sanguinet, H2X 3E4 Montreal, Quebec, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Roberge', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, 1051, Rue Sanguinet, H2X 3E4 Montreal, Quebec, Canada.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Masucci', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, 1051, Rue Sanguinet, H2X 3E4 Montreal, Quebec, Canada.""}, {'ForeName': 'Corentin', 'Initials': 'C', 'LastName': 'Richard', 'Affiliation': ""Centre de Recherche Du Centre Hospitalier de L'Université de Montréal (CRCHUM), 900, Rue Saint-Denis, Pavillon R, H2X 0A9 Montreal, Quebec, Canada.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Menard', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, 1051, Rue Sanguinet, H2X 3E4 Montreal, Quebec, Canada.""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Routy', 'Affiliation': ""Centre de Recherche Du Centre Hospitalier de L'Université de Montréal (CRCHUM), 900, Rue Saint-Denis, Pavillon R, H2X 0A9 Montreal, Quebec, Canada.""}]",Clinical and translational radiation oncology,['10.1016/j.ctro.2021.12.008']
3249,35242999,Mechanistic study of the effect of Endothelin SNPs in microvascular angina - Protocol of the PRIZE Endothelin Sub-Study.,"Introduction


Microvascular angina is a common cause of ischemia with non-obstructive coronary arteries (INOCA) and limited therapeutic options are available to those affected. Endothelin-1 (ET-1) is a potent vasoconstrictor implicated in the pathophysiology of microvascular angina. A large randomised, double blinded, placebo controlled crossover trial, the PRecIsion medicine with ZibotEntan in microvascular angina (PRIZE) trial is currently underway, investigating an endothelin receptor antagonist - Zibotentan, as a new drug treatment for microvascular angina. The trial uses a 'precision medicine' approach by preferential selection of those with higher ET-1 expression conferred by the PHACTR1 minor G allele single nucleotide polymorphism (SNP). The incidence of this SNP occurs in approximately one third of the population therefore a considerable number of screened patients will be ineligible for randomisation and the treatment phase of the trial.
Methods


In the PRIZE Endothelin (ET) Sub-Study, patients screened out of the PRIZE trial will be genotyped for other genetic variants in the ET-1 pathway. These will be correlated with phenotypic characteristics including exercise tolerance, angina severity and quantitative measures of microvascular function on cardiovascular MRI as well as mechanistic data on endothelin pathway signalling.
Conclusions


The study will provide a comprehensive genotype and phenotype bio-resource identifying novel ET-1 genotypes to inform the potential wider use of endothelin receptor antagonists for this indication.",2022,The trial uses a 'precision medicine' approach by preferential selection of those with higher ET-1 expression conferred by the PHACTR1 minor G allele single nucleotide polymorphism (SNP).,[],"['PRIZE Endothelin (ET', 'placebo', 'PRecIsion medicine with ZibotEntan', 'PRIZE', 'Endothelin-1 (ET-1', 'Endothelin SNPs']",[],[],"[{'cui': 'C2718059', 'cui_str': 'P Health'}, {'cui': 'C0206064', 'cui_str': 'Cardiac syndrome X'}, {'cui': 'C0079284', 'cui_str': 'Endothelin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}]",[],,0.256677,The trial uses a 'precision medicine' approach by preferential selection of those with higher ET-1 expression conferred by the PHACTR1 minor G allele single nucleotide polymorphism (SNP).,"[{'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Abraham', 'Affiliation': 'Royal Papworth Hospital NHS Foundation Trust., Papworth Road, Cambridge Biomedical Campus, Cambridge CB2 0AY, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Morrow', 'Affiliation': 'NHS Greater Glasgow and Clyde Health Board., Gartnavel Royal Hospital Campus, 1055 Great Western Road, Glasgow G12 0XH, United Kingdom.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Oliveira', 'Affiliation': 'Royal Papworth Hospital NHS Foundation Trust., Papworth Road, Cambridge Biomedical Campus, Cambridge CB2 0AY, United Kingdom.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Weir-McCall', 'Affiliation': 'Royal Papworth Hospital NHS Foundation Trust., Papworth Road, Cambridge Biomedical Campus, Cambridge CB2 0AY, United Kingdom.'}, {'ForeName': 'Emma E', 'Initials': 'EE', 'LastName': 'Davenport', 'Affiliation': 'Wellcome Sanger Institute., Wellcome Genome Campus, Hinxton, Cambridge CB10 1SA, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'NHS Greater Glasgow and Clyde Health Board., Gartnavel Royal Hospital Campus, 1055 Great Western Road, Glasgow G12 0XH, United Kingdom.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Davenport', 'Affiliation': 'University of Cambridge, The Old Schools, Trinity Lane, Cambridge CB2 1TN, United Kingdom.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hoole', 'Affiliation': 'Royal Papworth Hospital NHS Foundation Trust., Papworth Road, Cambridge Biomedical Campus, Cambridge CB2 0AY, United Kingdom.'}]",International journal of cardiology. Heart & vasculature,['10.1016/j.ijcha.2022.100980']
3250,35243443,Personalized pacing for diastolic dysfunction and heart failure with preserved ejection fraction: Design and rationale for the  my PACE randomized controlled trial.,"Background


Patients with pacemakers and heart failure with preserved ejection fraction (HFpEF) or isolated diastolic dysfunction (DD) may benefit from a higher backup heart rate (HR) setting compared with the standard setting of 60 bpm.
Objective


The purpose of this study was to assess the effects of a personalized backup HR setting ( my PACE group) compared with 60 bpm (control group).
Methods


In this prospective, blinded, randomized controlled study, pacemaker patients with DD or HFpEF and atrial pacing with intrinsic ventricular conduction or conduction system or biventricular pacing are randomized to the  my PACE group or control group for 1 year. The primary outcome is the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores. Secondary endpoints include changes in N-terminal pro-brain natriuretic peptide levels, physical and emotional MLHFQ subscores, and pacemaker-detected atrial arrhythmia burden, patient activity levels, and thoracic impedance; hospitalization for heart failure, atrial fibrillation, cerebrovascular accident, or myocardial infarction; and loop diuretic or antiarrhythmic medication initiation or up-titration. A sample size of 118 subjects is expected to allow detection of a 5-point change in MLHFQ score in an intention-to-treat analysis and allow initial assessment of clinical outcomes and subgroup analyses.
Results


Enrollment began in July 2019. As of November 2020, 107 subjects have been enrolled. It is projected that the 1-year follow-up will be completed by December 2021.
Conclusion


Atrial pacing with intrinsic ventricular conduction or advanced ventricular pacing at a higher, personalized backup HR may be a therapeutic target for patients with isolated DD or HFpEF. The  my PACE trial is designed to test this hypothesis.",2022,"Secondary endpoints include changes in N-terminal pro-brain natriuretic peptide levels, physical and emotional MLHFQ subscores, and pacemaker-detected atrial arrhythmia burden, patient activity levels, and thoracic impedance; hospitalization for heart failure, atrial fibrillation, cerebrovascular accident, or myocardial infarction; and loop diuretic or antiarrhythmic medication initiation or up-titration.","['patients with isolated DD or HFpEF', '107 subjects have been enrolled', 'pacemaker patients with DD or HFpEF and atrial pacing with intrinsic ventricular conduction or conduction system or biventricular pacing', '118 subjects', '\n\n\nPatients with pacemakers and heart failure with preserved ejection fraction (HFpEF) or isolated diastolic dysfunction (DD']","['Personalized pacing', 'Atrial pacing with intrinsic ventricular conduction or advanced ventricular pacing']","['MLHFQ score', 'change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores', 'changes in N-terminal pro-brain natriuretic peptide levels, physical and emotional MLHFQ subscores, and pacemaker-detected atrial arrhythmia burden, patient activity levels, and thoracic impedance; hospitalization for heart failure, atrial fibrillation, cerebrovascular accident, or myocardial infarction; and loop diuretic or antiarrhythmic medication initiation or up-titration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2936372', 'cui_str': 'Biventricular Pacing'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}]","[{'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1533071', 'cui_str': 'N terminal pro-brain natriuretic peptide level'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456223', 'cui_str': 'Thoracic impedance'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}]",,0.225377,"Secondary endpoints include changes in N-terminal pro-brain natriuretic peptide levels, physical and emotional MLHFQ subscores, and pacemaker-detected atrial arrhythmia burden, patient activity levels, and thoracic impedance; hospitalization for heart failure, atrial fibrillation, cerebrovascular accident, or myocardial infarction; and loop diuretic or antiarrhythmic medication initiation or up-titration.","[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Infeld', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Kramer', 'Initials': 'K', 'LastName': 'Wahlberg', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Cicero', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Meagher', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Habel', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Muthu Krishnan', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Daniel N', 'Initials': 'DN', 'LastName': 'Silverman', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Lustgarten', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Meyer', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}]",Heart rhythm O2,['10.1016/j.hroo.2021.11.015']
3251,35243434,"Dose-limiting, adverse event-associated bradycardia with β-blocker treatment of atrial fibrillation in the GENETIC-AF trial.","Background


Heart failure (HF) patients with atrial fibrillation (AF) often have conduction system disorders, which may be worsened by β-blocker therapy.
Objective


In a post hoc analysis we examined the prevalence of bradycardia and its association with adverse events (AEs) and failure to achieve target dose in the GENETIC-AF trial.
Methods


Patients randomized to metoprolol (n = 125) or bucindolol (n = 131) entering 24-week efficacy follow-up and receiving study medication were evaluated. Bradycardia was defined as an electrocardiogram (ECG) heart rate (HR) <60 beats per minute (bpm) and severe bradycardia <50 bpm.
Results


Mean HR in sinus rhythm (SR) was 62.6 ± 12.5 bpm for metoprolol and 68.3 ± 11.1 bpm for bucindolol ( P  < .0001), but in AF HRs were not different (87.5 bpm vs 89.7 bpm, respectively). Episodes per patient for bucindolol vs metoprolol were 0.82 vs 2.08 ( P  < .001) for bradycardia and 0.24 vs 0.57 for severe bradycardia ( P  < .001), with 98.9% of the episodes occurring in SR. Patients experiencing bradycardia had a 4.15-fold higher prevalence of study medication dose reduction ( P  <.0001) compared to patients without bradycardia. Fewer patients receiving metoprolol were at target dose (61.7% vs 74.9% for bucindolol,  P  < .0001) at ECG recordings, and bradycardia AEs were more prevalent in the metoprolol group (13 vs 1 for bucindolol,  P  = .001). On multivariate analysis of 21 candidate bradycardia predictors including presence of a device with pacing capability, bucindolol treatment was associated with the greatest degree of prevention (Z odds ratio  -4.24,  P  < .0001).
Conclusion


In AF-prone HF patients bradycardia may limit the effectiveness of β blockers, and this property is agent-dependent.",2022,Patients experiencing bradycardia had a 4.15-fold higher prevalence of study medication dose reduction ( P  <.0001) compared to patients without bradycardia.,['\n\n\nHeart failure (HF) patients with atrial fibrillation (AF'],"['bucindolol', 'bucindolol vs metoprolol', 'metoprolol']","['Bradycardia', 'Mean HR in sinus rhythm (SR', 'bradycardia', 'electrocardiogram (ECG) heart rate (HR) <60 beats per minute (bpm) and severe bradycardia', 'severe bradycardia', 'bradycardia AEs', 'AF HRs']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0054196', 'cui_str': 'bucindolol'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}]","[{'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",131.0,0.171295,Patients experiencing bradycardia had a 4.15-fold higher prevalence of study medication dose reduction ( P  <.0001) compared to patients without bradycardia.,"[{'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Ohio State University Medical Center, Columbus, Ohio.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Piccini', 'Affiliation': 'Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Dufton', 'Affiliation': 'ARCA biopharma, Inc, Westminster, Colorado.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Carroll', 'Affiliation': 'ARCA biopharma, Inc, Westminster, Colorado.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, California.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Fairfax, Virginia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Marshall', 'Affiliation': 'ARCA biopharma, Inc, Westminster, Colorado.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Aleong', 'Affiliation': 'University of Colorado Anschutz Medical Campus Division of Cardiology, Aurora, Colorado.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'University of Groningen, University Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Rienstra', 'Affiliation': 'University of Groningen, University Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Wilton', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'White', 'Affiliation': 'Montreal Heart Institute, Montreal, Canada.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Sauer', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Sophia P', 'Initials': 'SP', 'LastName': 'Huebler', 'Affiliation': 'ARCA biopharma, Inc, Westminster, Colorado.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, California.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Bristow', 'Affiliation': 'ARCA biopharma, Inc, Westminster, Colorado.'}]",Heart rhythm O2,['10.1016/j.hroo.2021.11.005']
3252,35243431,The AF-FICIENT magnetic resonance imaging and endoscopy safety substudy: A visually guided radiofrequency balloon ablation catheter for pulmonary vein isolation.,"Background


Early experience with a novel multielectrode saline-irrigated radiofrequency balloon (RFB) catheter with an integrated camera system found that it was safe and effective in performing single-shot pulmonary vein isolation (PVI) for atrial fibrillation.
Objective


The purpose of this study was to further assess potential treatment risks by looking for subclinical events.
Methods


The study was performed at 2 sites. Patients underwent PVI by RFB. A control group underwent conventional point-by-point radiofrequency ablation. Stroke scale questionnaire and brain magnetic resonance imaging (MRI) were performed before and after the ablation procedure, and esophageal endoscopy was performed after the procedure in RFB patients only.
Results


We enrolled 27 patients in the RFB group and 15 patients in the control group. The RFB and control groups were well matched [predominantly male: 62% vs 53%; CHA 2 DS 2 -VASc score: 1.9 ± 1.3 vs 1.5 ± 1.6; mean age 60 years in both groups]. All patients underwent successful ablation and completed study assessments. Clinically silent, new MRI diffusion weighted imaging cerebral lesions were observed in 8 patients (30%) in the RFB group and 1 patient (7%) in the control group, and 11 susceptibility weighted imaging lesions in the RFB group and 1 in the control group. Endoscopy showed a minor thermal injury in 1 patient in the RFB group.
Conclusion


An increased rate of clinically silent cerebral events was seen in the RFB group. A low rate of esophageal thermal injury was observed.",2022,"Clinically silent, new MRI diffusion weighted imaging cerebral lesions were observed in 8 patients (30%) in the RFB group and 1 patient (7%) in the control group, and 11 susceptibility weighted imaging lesions in the RFB group and 1 in the control group.",['enrolled 27 patients in the RFB group and 15 patients in the control group'],"['novel multielectrode saline-irrigated radiofrequency balloon (RFB) catheter', 'radiofrequency balloon ablation catheter', 'conventional point-by-point radiofrequency ablation']","['rate of clinically silent cerebral events', 'Clinically silent, new MRI diffusion weighted imaging cerebral lesions', 'Stroke scale questionnaire and brain magnetic resonance imaging (MRI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",27.0,0.0326461,"Clinically silent, new MRI diffusion weighted imaging cerebral lesions were observed in 8 patients (30%) in the RFB group and 1 patient (7%) in the control group, and 11 susceptibility weighted imaging lesions in the RFB group and 1 in the control group.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Daly', 'Affiliation': 'Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hurrell', 'Affiliation': 'Department of Radiology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Melton', 'Affiliation': 'Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Lim', 'Affiliation': 'Department of Gastroenterology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Audrius', 'Initials': 'A', 'LastName': 'Aidietis', 'Affiliation': 'Centre for Cardiology and Angiology, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Gediminas', 'Initials': 'G', 'LastName': 'Rackauskas', 'Affiliation': 'Centre for Cardiology and Angiology, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Al-Ahmad', 'Affiliation': ""Texas Cardiac Arrhythmia Institute at St. David's Medical Centre, Austin, Texas.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Crozier', 'Affiliation': 'Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand.'}]",Heart rhythm O2,['10.1016/j.hroo.2021.12.001']
3253,35243421,Selective targeting of skin pathobionts and inflammation with topically applied lactobacilli.,"Tailored skin microbiome modulation approaches with probiotics are highly challenging. Here, we show that lactobacilli are underestimated members of the skin microbiota. We select specific strains of nomadic lactobacilli for their functional applicability on the skin and capacity to inhibit growth and inflammation by skin pathobionts. The strains are formulated as microcapsules for topical formulations and tested in patients with mild-to-moderate acne. The selected lactobacilli are able to reduce inflammatory lesions in a pilot and placebo-controlled study. Daily application for 8 weeks is associated with an  in vivo  temporary modulation of the microbiome, including a reduction in relative abundance of staphylococci and  Cutibacterium acnes , and an increase in lactobacilli. The reduction in inflammatory lesions is still apparent 4 weeks after the topical application of the lactobacilli ended, indicating a possible additional immunomodulatory effect. This study shows that carefully selected and formulated lactobacilli are a viable therapeutic option for common acne lesions.",2022,"Daily application for 8 weeks is associated with an  in vivo  temporary modulation of the microbiome, including a reduction in relative abundance of staphylococci and  Cutibacterium acnes , and an increase in lactobacilli.",['patients with mild-to-moderate acne'],[],['inflammatory lesions'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]",[],"[{'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}]",,0.0331776,"Daily application for 8 weeks is associated with an  in vivo  temporary modulation of the microbiome, including a reduction in relative abundance of staphylococci and  Cutibacterium acnes , and an increase in lactobacilli.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lebeer', 'Affiliation': 'University of Antwerp, Department of Bioscience Engineering, Groenenborgerlaan 171, B-2020 Antwerp, Belgium.'}, {'ForeName': 'Eline F M', 'Initials': 'EFM', 'LastName': 'Oerlemans', 'Affiliation': 'University of Antwerp, Department of Bioscience Engineering, Groenenborgerlaan 171, B-2020 Antwerp, Belgium.'}, {'ForeName': 'Ingmar', 'Initials': 'I', 'LastName': 'Claes', 'Affiliation': 'University of Antwerp, Department of Bioscience Engineering, Groenenborgerlaan 171, B-2020 Antwerp, Belgium.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Henkens', 'Affiliation': 'University of Antwerp, Department of Pharmaceutical, Biomedical and Veterinary Sciences, Laboratory of Pharmaceutical Technology and Biopharmacy, Universiteitsplein 1, B-2610 Wilrijk, Belgium.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'Delanghe', 'Affiliation': 'University of Antwerp, Department of Bioscience Engineering, Groenenborgerlaan 171, B-2020 Antwerp, Belgium.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Wuyts', 'Affiliation': 'University of Antwerp, Department of Bioscience Engineering, Groenenborgerlaan 171, B-2020 Antwerp, Belgium.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Spacova', 'Affiliation': 'University of Antwerp, Department of Bioscience Engineering, Groenenborgerlaan 171, B-2020 Antwerp, Belgium.'}, {'ForeName': 'Marianne F L', 'Initials': 'MFL', 'LastName': 'van den Broek', 'Affiliation': 'University of Antwerp, Department of Bioscience Engineering, Groenenborgerlaan 171, B-2020 Antwerp, Belgium.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Tuyaerts', 'Affiliation': 'University of Antwerp, Department of Bioscience Engineering, Groenenborgerlaan 171, B-2020 Antwerp, Belgium.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Wittouck', 'Affiliation': 'University of Antwerp, Department of Bioscience Engineering, Groenenborgerlaan 171, B-2020 Antwerp, Belgium.'}, {'ForeName': 'Ilke', 'Initials': 'I', 'LastName': 'De Boeck', 'Affiliation': 'University of Antwerp, Department of Bioscience Engineering, Groenenborgerlaan 171, B-2020 Antwerp, Belgium.'}, {'ForeName': 'Camille N', 'Initials': 'CN', 'LastName': 'Allonsius', 'Affiliation': 'University of Antwerp, Department of Bioscience Engineering, Groenenborgerlaan 171, B-2020 Antwerp, Belgium.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Kiekens', 'Affiliation': 'University of Antwerp, Department of Pharmaceutical, Biomedical and Veterinary Sciences, Laboratory of Pharmaceutical Technology and Biopharmacy, Universiteitsplein 1, B-2610 Wilrijk, Belgium.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Lambert', 'Affiliation': 'University Hospital Antwerp/University of Antwerp, Department of Dermatology and Venereology, Wilrijkstraat 10, 2650 Edegem, Belgium.'}]",Cell reports. Medicine,['10.1016/j.xcrm.2022.100521']
3254,35243406,Fostering emotional self-regulation in female teachers at the public teaching network: A mindfulness-based intervention improving psychological measures and inflammatory biomarkers.,"Objective


To examine the effect of a mindfulness-based program specifically designed for teachers in reducing perceived stress and improving the quality of experienced emotion in female active working teachers. A second outcome evaluated is the associated change in cellular inflammatory activity, measured by peripheral blood levels of cytokines.
Method


Eighty-eight female active teachers from public schools from São Paulo Municipality were recruited, and randomly allocated to an eight-week Mindfulness-Based Health Program for Educators (MBHP-Educa) or to Neuroscience for Education Program (Neuro-Educa: active control group). The venue of both programs were several public school facilities, where many of the teachers actually worked. Both groups received activities during eight weeks in a 2 ​h/week regimen, totalizing 16 ​h. Sixty-five participants completed the program and pre- and post-interventions measures were taken from the following scales: Interpersonal Multidimensional Reactivity Scale (IRI), Positive-and-Negative Affects Scale (PANAS), Perceived Stress Scale (PSS), Connor-Davidson Resilience Scale (CD-RISC), and a primary outcome in Ryff's Psychological Well-Being Scale (PBWS). At pre-and post-intervention, blood samples were collected for the measurement of several important inflammatory biomarkers, Tumor Necrosis Factor - α (TNF-α), Interleukin 1β (IL-1β), Interleukin 6 (IL-6), Interleukin 8 (IL-8), Interleukin 10 (IL-10) and Interleukin 12p70 (IL-12P70) through flow cytometry assay. Intervention effects were analyzed via Generalized mixed models (GLMM).
Results


According to the GLMM, MBHP-Educa significantly reduced the scores of perceived stress (p ​< ​0.0001), and negative affect (p ​< ​0.0001) compared to active control group (Neuro-Educa). Conversely, an increase was observed on Psychological Well Being Scale in dimensions of Self-acceptance (p ​< ​0.0001), and Autonomy (p ​= ​0.001), as well as improvements in Resilience (p ​< ​0.0001), and Positive Affect (p ​< ​0.0001). MBHP-Educa also promoted a reduction in the levels of IL-6 (p ​= ​0.003), IL-8 (p ​= ​0.036), and increase in the levels of IL-10 (p ​< ​0.0001) and IL-12p70 (p ​< ​0.044). TNF-α, IL-1β, and IL-10p70 showed results below theoretical limit of detection accepted for CBA kit.
Conclusions


Our data suggest that mindfulness-based interventions introduced as a strategy for reducing stress, promoting well-being and improve immune function can be a useful asset in promoting psychological health among teachers in Basic Education.",2022,"MBHP-Educa also promoted a reduction in the levels of IL-6 (p ​= ​0.003), IL-8","['female active working teachers', 'female teachers at the public teaching network', 'Method\n\n\nEighty-eight female active teachers from public schools from São Paulo Municipality']",['eight-week Mindfulness-Based Health Program for Educators'],"['IL-8', 'scores of perceived stress', 'peripheral blood levels of cytokines', 'levels of IL-10', 'several important inflammatory biomarkers, Tumor Necrosis Factor - α (TNF-α), Interleukin 1β (IL-1β), Interleukin 6', 'levels of IL-6', ""Interpersonal Multidimensional Reactivity Scale (IRI), Positive-and-Negative Affects Scale (PANAS), Perceived Stress Scale (PSS), Connor-Davidson Resilience Scale (CD-RISC), and a primary outcome in Ryff's Psychological Well-Being Scale (PBWS"", 'cellular inflammatory activity', 'Psychological', 'IL-6), Interleukin 8 (IL-8), Interleukin 10 (IL-10) and Interleukin 12p70 (IL-12P70) through flow cytometry assay']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0557800', 'cui_str': 'Public school'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C1099355', 'cui_str': 'RISC Multicomponent Nuclease'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]",88.0,0.0516958,"MBHP-Educa also promoted a reduction in the levels of IL-6 (p ​= ​0.003), IL-8","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'Department of Preventive Medicine, Graduate Program in Collective Health, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rodrigues de Oliveira', 'Affiliation': 'Department of Preventive Medicine, Graduate Program in Collective Health, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Palace-Berl', 'Affiliation': 'Department of Pathology, Graduate Program in Pathology, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'de Mello Ponteciano', 'Affiliation': 'Department of Pathology, Graduate Program in Pathology, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Fungaro Rissatti', 'Affiliation': 'Department of Pathology, Graduate Program in Pathology, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Valéria', 'Initials': 'V', 'LastName': 'Piassa Pollizi', 'Affiliation': 'Department of Preventive Medicine, Graduate Program in Collective Health, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Flávia', 'Initials': 'F', 'LastName': 'Sardela de Miranda', 'Affiliation': 'Laboratory of Imunomodulation, Department of Imunology, Instituto de Ciências Biomédicas, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Vânia', 'Initials': 'V', 'LastName': ""D'Almeida"", 'Affiliation': 'Department of Psychobiology, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Demarzo', 'Affiliation': 'Department of Preventive Medicine, Graduate Program in Collective Health, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}]","Brain, behavior, & immunity - health",['10.1016/j.bbih.2022.100427']
3255,35243388,Improving the Early Detection of Clinically Significant Prostate Cancer in Men in the Challenging Prostate Imaging-Reporting and Data System 3 Category.,"Background


Prostate Imaging-Reporting and Data System (PI-RADS) category 3 is a challenging scenario for detection of clinically significant prostate cancer (csPCa) and some tools can improve the selection of appropriate candidates for prostate biopsy.
Objective


To assess the performance of the European Randomized Study of Screening for Prostate Cancer (ERSPC) magnetic resonance imaging (MRI) model, the new Proclarix test, and prostate-specific antigen density (PSAD) in selecting candidates for prostate biopsy among men in the PI-RADS 3 category.
Design setting and participants


We conducted a head-to-head prospective analysis of 567 men suspected of having PCa for whom guided and systematic biopsies were scheduled between January 2018 and March 2020 in a single academic institution. A PI-RADS v.2 category 3 lesion was identified in 169 men (29.8%).
Outcome measurement and statistical analysis


csPCa, insignificant PCa (iPCa), and unnecessary biopsy rates were analysed. csPCa was defined as grade group ≥2. Receiver operating characteristic (ROC) curves, decision curve analysis curves, and clinical utility curves were plotted.
Results and limitations


PCa was detected in 53/169 men (31.4%) with a PI-RADS 3 lesion, identified as csPCa in 25 (14.8%) and iPCa in 28 (16.6%). The area under the ROC curve for csPCa detection was 0.703 (95% confidence interval [CI] 0.621-0.768) for Proclarix, 0.657 (95% CI 0.547-0.766) for the ERSPC MRI model, and 0.612 (95% CI 0.497-0.727) for PSAD ( p  = 0.027). The threshold with the highest sensitivity was 10% for Proclarix, 1.5% for the ERSPC MRI model, and 0.07 ng/ml/cm 3  for PSAD, which yielded sensitivity of 100%, 91%, and 84%, respectively. Some 21.3%, 26.2%, and 7.1% of biopsies would be avoided with Proclarix, PSAD, and the ERSPC MRI model, respectively. Proclarix showed a net benefit over PSAD and the ERSPC MRI model. Both Proclarix and PSAD reduced iPCa overdetection from 16.6% to 11.3%, while the ERSPC MRI model reduced iPCa overdetection to 15.4%.
Conclusions


Proclarix was more accurate in selecting appropriate candidates for prostate biopsy among men in the PI-RADS 3 category when compared to PSAD and the ERSPC MRI model. Proclarix detected 100% of csPCa cases and would reduce prostate biopsies by 21.3% and iPCa overdetection by 5.3%.
Patient summary


We compared three methods and found that the Proclarix test can optimise the detection of clinically significant prostate cancer in men with a score of 3 on the Prostate Imaging-Reporting and Data System for magnetic resonance imaging scans.",2022,"Conclusions


Proclarix was more accurate in selecting appropriate candidates for prostate biopsy among men in the PI-RADS 3 category when compared to PSAD and the ERSPC MRI model.","['participants', '567 men suspected of having PCa for whom guided and systematic biopsies were scheduled between January 2018 and March 2020 in a single academic institution', 'prostate biopsy among men in the PI-RADS 3 category', '169 men (29.8']",['Screening for Prostate Cancer (ERSPC) magnetic resonance imaging (MRI'],"['highest sensitivity', 'statistical analysis\n\n\ncsPCa, insignificant PCa (iPCa), and unnecessary biopsy rates', 'iPCa overdetection', 'limitations\n\n\nPCa', 'Receiver operating characteristic (ROC) curves, decision curve analysis curves, and clinical utility curves', 'reduce prostate biopsies', 'csPCa']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1622900', 'cui_str': 'Data Systems'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}]",567.0,0.30255,"Conclusions


Proclarix was more accurate in selecting appropriate candidates for prostate biopsy among men in the PI-RADS 3 category when compared to PSAD and the ERSPC MRI model.","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Morote', 'Affiliation': ""Department of Urology, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Campistol', 'Affiliation': ""Prostate Cancer Research Group, Vall d'Hebron Research Institute, Barcelona, Spain.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Triquell', 'Affiliation': ""Prostate Cancer Research Group, Vall d'Hebron Research Institute, Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Celma', 'Affiliation': ""Department of Urology, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Regis', 'Affiliation': ""Department of Urology, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'de Torres', 'Affiliation': ""Prostate Cancer Research Group, Vall d'Hebron Research Institute, Barcelona, Spain.""}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Semidey', 'Affiliation': ""Prostate Cancer Research Group, Vall d'Hebron Research Institute, Barcelona, Spain.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Mast', 'Affiliation': ""Department of Radiology, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Santamaria', 'Affiliation': ""Prostate Cancer Research Group, Vall d'Hebron Research Institute, Barcelona, Spain.""}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Planas', 'Affiliation': ""Department of Urology, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Trilla', 'Affiliation': ""Department of Urology, Vall d'Hebron Hospital, Barcelona, Spain.""}]",European urology open science,['10.1016/j.euros.2021.12.009']
3256,35243387,Trial-based Cost-effectiveness Analysis of an Immediate Postoperative Mitomycin C Instillation in Patients with Non-muscle-invasive Bladder Cancer.,"Background


Bladder cancer imposes a significant public health burden on the European Union. There is a need for cost-effective treatment and follow-up regimens.
Objective


To assess the cost-effectiveness of immediate mitomycin C (MMC) instillation within 1 d after surgery compared to delayed MMC instillation within 2 wk after surgery with further adjuvant treatment, depending on the patient's risk group.
Design setting and participants


This economic evaluation was based on a randomized controlled trial among 2243 Dutch patients with non-muscle-invasive bladder cancer (NMIBC) patients from a health care perspective over a 3-yr time period.
Outcome measurements and statistical analysis


The treatment effect was measured as time to recurrence and recurrence-free survival. Missing effect data were imputed with multiple imputation. Health care utilization and related costs were estimated on the basis of treatment protocols for NMIBC patients in the Netherlands. Statistical uncertainty was estimated using bootstrapping and is graphically presented using cost-effectiveness planes and cost-effectiveness acceptability curves.
Results and limitations


Time to recurrence was significantly longer for immediate MMC instillation (27.31 mo) than for delayed MMC instillation (24.97 mo), with an adjusted mean difference of 2.21 mo (95% confidence interval [CI] 1.58-2.84). The proportion of patients with recurrence-free survival was significantly higher after immediate MMC instillation (0.65) than after delayed MMC instillation (0.56), with an adjusted mean difference of 0.08 (95% CI 0.06-0.11). Total mean health care costs per patient were significantly lower for immediate MMC instillation (€22 959) than for delayed MMC instillation (€24 624), with an adjusted mean difference of -€1350 (95% CI -€1799 to -€900). The study is limited by the retrospective estimation of costs.
Conclusions


This trial-based cost-effectiveness analysis shows that from a health care perspective, immediate MMC instillation is more effective and less expensive compared to delayed MMC instillation.
Patient summary


We assessed the cost-effectiveness of immediate bladder instillation of mitomycin C after surgery to reduce the risk of recurrence after removal of the bladder tumor as compared to delayed instillation in a large Dutch population of patients with non-muscle-invasive bladder cancer. We found that immediate instillation was more effective and less expensive than delayed instillation. We conclude that immediate mitomycin C instillation is a cost-effective treatment for non-muscle-invasive bladder cancer.",2022,"Total mean health care costs per patient were significantly lower for immediate MMC instillation (€22 959) than for delayed MMC instillation (€24 624), with an adjusted mean difference of -€1350 (95% CI -€1799 to -€900).","['patients with non-muscle-invasive bladder cancer', 'non-muscle-invasive bladder cancer', '2243 Dutch patients with non-muscle-invasive bladder cancer (NMIBC) patients from a health care perspective over a 3-yr time period', 'NMIBC patients in the Netherlands', 'Patients with Non-muscle-invasive Bladder Cancer', 'participants']","['mitomycin C', 'Immediate Postoperative Mitomycin C Instillation', 'immediate mitomycin C instillation', 'immediate mitomycin C (MMC) instillation']","['cost-effectiveness', 'time to recurrence and recurrence-free survival', 'Total mean health care costs per patient', 'proportion of patients with recurrence-free survival', 'cost-effectiveness planes and cost-effectiveness acceptability curves']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",2243.0,0.12842,"Total mean health care costs per patient were significantly lower for immediate MMC instillation (€22 959) than for delayed MMC instillation (€24 624), with an adjusted mean difference of -€1350 (95% CI -€1799 to -€900).","[{'ForeName': 'Anouk E', 'Initials': 'AE', 'LastName': 'Hentschel', 'Affiliation': 'Department of Urology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Blankvoort', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bosschieter', 'Affiliation': 'Department of Urology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'André N', 'Initials': 'AN', 'LastName': 'Vis', 'Affiliation': 'Department of Urology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'R Jeroen A', 'Initials': 'RJA', 'LastName': 'van Moorselaar', 'Affiliation': 'Department of Urology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Jakko A', 'Initials': 'JA', 'LastName': 'Nieuwenhuijzen', 'Affiliation': 'Department of Urology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}]",European urology open science,['10.1016/j.euros.2021.12.008']
3257,35243362,"The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial.","Background


Approximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement.
Methods


We did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0-10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361.
Findings


Between Sept 6, 2016, and May 31, 2019, 363 participants were randomly assigned to receive the intervention plus usual care (n=242) or to receive usual care alone (n=121). Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White. 313 (86%) patients provided follow-up data at 12 months after randomisation (213 assigned to the intervention plus usual care and 100 assigned to usual care alone). At 12 months, the mean between-group difference in the BPI severity score was -0·65 (95% CI -1·17 to -0·13; p=0·014) and the mean between-group difference in the BPI interference score was -0·68 (-1·29 to -0·08; p=0·026), both favouring the intervention. From an NHS and personal social services perspective, the intervention was cost-effective (greater improvement with lower cost), with an incremental net monetary benefit of £1256 (95% CI 164 to 2348) at £20 000 per QALY threshold. One adverse reaction of participant distress was reported in the intervention group.
Interpretation


STAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery.
Funding


National Institute for Health Research.",2022,"Interpretation


STAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery.
","['363 participants', 'eight UK National Health Service (NHS) hospitals', 'Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White', 'chronic pain after total knee replacement', 'patients with pain at 3 months after total knee replacement', 'People with chronic pain at 3 months after total knee replacement surgery']","['Replacement (STAR) care pathway plus usual care, or to usual care alone', 'STAR intervention', 'intervention plus usual care (n=242) or to receive usual care alone']","['clinical effectiveness and cost-effectiveness', 'Quality-adjusted life-years (QALYs', 'self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales', 'pain outcomes', 'BPI interference score', 'BPI severity score', 'adverse reaction of participant distress']","[{'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",363.0,0.183526,"Interpretation


STAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery.
","[{'ForeName': 'Vikki', 'Initials': 'V', 'LastName': 'Wylde', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Bertram', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sanderson', 'Affiliation': 'Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Noble', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Howells', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Beswick', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Ashley W', 'Initials': 'AW', 'LastName': 'Blom', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Moore', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Warwick, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Walsh', 'Affiliation': 'Pain Centre, Versus Arthritis/National Institute for Health Research Nottingham Biomedical Research Centre, University of Nottingham and Sherwood Forest Hospitals NHS Foundation Trust, Nottingham, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Eccleston', 'Affiliation': 'Centre for Pain Research, The University of Bath, Bath, UK.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Garfield', 'Affiliation': 'Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'White', 'Affiliation': 'Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Toms', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Gooberman-Hill', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Rheumatology,['10.1016/S2665-9913(21)00371-4']
3258,35243341,Chronic and Residual Effects of a Two-Week Foam Rolling Intervention on Ankle Flexibility and Dynamic Balance.,"Background


Foam rolling has been shown to acutely improve joint range of motion (ROM). However, limited knowledge exists on the chronic and residual effects. The primary purpose of this study was to examine the chronic and residual effects of a 2-week roller-massager intervention on ankle dorsiflexion ROM and dynamic balance.
Methods


Forty-two participants (24.3 ± 2.5 years, 33 males, 9 females) were randomly assigned to either roller-massage (RM) or control group (= no intervention). Ankle ROM was assessed with the weight-bearing lunge test (WBLT) and dynamic balance with the Y-Balance test for both limbs. The RM group was instructed to roll their calf muscles for three sets of 60 s per leg on 6 days a week over 2 weeks. Acute effects were measured during baseline testing for dorsiflexion ROM and dynamic balance immediately after foam rolling. Chronic and residual effects were measured 1 day and 7 days after the intervention period. Multivariate ANOVA was performed for  post-hoc  comparisons to determine acute, chronic, and residual effects.
Results


Significant acute and chronic foam rolling effects ( p  <0.05) were found for ankle dorsiflexion ROM. The chronic increase in ROM slightly decreased 7 days post-intervention but remained significantly above baseline ( p  < 0.05). Regarding dynamic balance, there were no acute but chronic ( p  < 0.05) and residual ( p  < 0.05) effects.
Conclusion


Using a roller-massager for a 2-week period chronically increases ROM and dynamic balance. These increases are still significant 7 days post-intervention emphasizing the sustainability of foam rolling effects.",2022,Significant acute and chronic foam rolling effects ( p  <0.05) were found for ankle dorsiflexion ROM.,"['Methods\n\n\nForty-two participants (24.3 ± 2.5 years, 33 males, 9 females']","['roller-massage (RM) or control group', 'roller-massager intervention', 'Two-Week Foam Rolling Intervention']","['ankle dorsiflexion ROM and dynamic balance', 'Ankle Flexibility and Dynamic Balance', 'Acute effects', 'ROM', 'dorsiflexion ROM and dynamic balance', 'ankle dorsiflexion ROM', 'Chronic and residual effects', 'weight-bearing lunge test (WBLT) and dynamic balance', 'Ankle ROM', 'ROM and dynamic balance']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0326180', 'cui_str': 'Coraciidae'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}]",42.0,0.0398583,Significant acute and chronic foam rolling effects ( p  <0.05) were found for ankle dorsiflexion ROM.,"[{'ForeName': 'Thomas Christoph', 'Initials': 'TC', 'LastName': 'Seever', 'Affiliation': 'Department of Human Movement Science and Exercise Physiology, Institute of Sports Science, University of Jena, Jena, Germany.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'Department of Human Movement Science and Exercise Physiology, Institute of Sports Science, University of Jena, Jena, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Zech', 'Affiliation': 'Department of Human Movement Science and Exercise Physiology, Institute of Sports Science, University of Jena, Jena, Germany.'}]",Frontiers in sports and active living,['10.3389/fspor.2022.799985']
3259,35243319,Radiation of parotid or submandibular glands is effective for drooling in patients with parkinsonism; a randomised double-blind placebo-controlled trial.,"Background


Drooling is a common symptom in patients with parkinsonism, causing physical and emotional distress. It is unknown which major salivary glands are the best candidates for irradiation to reduce drooling with minimal adverse events. Therefore, this study assessed the efficacy and safety of submandibular and parotid salivary gland irradiation to reduce drooling.
Methods


A prospective, randomised, double-blind, placebo-controlled trial was conducted at the University Medical Center Groningen, the Netherlands. After informed consent, 31 patients with parkinsonism and severe drooling according to the Unified Parkinson Disease Rating Scale (UPDRS) were included in this study. Exclusion criteria consisted of the use of anticholinergic drugs, the existence of salivary gland diseases, and/or an history of (pre)malignancies of the salivary glands. Patients were randomized for parotid-, submandibular- or sham irradiation (2x6 Gy with one week interval). Patients were evaluated at 1, 3, 6 and 12 months after radiation. Primary outcome measure was drooling severity according to the UPDRS. Secondary outcomes measures consisted of stimulated glandular salivary secretion rates and adverse effects.
Findings


Overall 31 parkinsonian patients were included. Initially 11 patients were radiated on the parotid glands, 10 patients on the submandibular glands and 10 patients were sham-radiated. After 6 months, the sham-radiated patients were actively treated after a second randomisation. One patient in the parotid radiation group discontinued his participation after three months due to physical deterioration. Radiation of parotid or submandibular glands significantly improved the existing drooling, as compared to placebo radiation. Parotid- and submandibular radiation was equally effective, but more patients in the submandibular radiated group reported sticky saliva vs. patients treated by parotid radiation (33∙33% vs. 13∙33%).
Interpretation


Major salivary gland radiation significantly improves drooling in parkinsonian patients with few adverse effects. However, parotid gland radiation is accompanied by fewer side effects and therefore is the preferred mode of radiation in this patient population.",2022,"Parotid- and submandibular radiation was equally effective, but more patients in the submandibular radiated group reported sticky saliva vs. patients treated by parotid radiation (33∙33% vs. 13∙33%).
","['parkinsonian patients with few adverse effects', 'University Medical Center Groningen, the Netherlands', 'patients with parkinsonism', 'patients with parkinsonism, causing physical and emotional distress', 'Overall 31 parkinsonian patients', '31 patients with parkinsonism and severe drooling according to the Unified Parkinson Disease Rating Scale (UPDRS) were included in this study', 'Initially 11 patients were radiated on the parotid glands, 10 patients on the submandibular glands and 10 patients were sham-radiated']","['submandibular and parotid salivary gland irradiation', 'placebo', 'Parotid- and submandibular radiation', 'parotid-, submandibular- or sham irradiation', 'Radiation of parotid or submandibular glands']","['drooling severity according to the UPDRS', 'existing drooling', 'sticky saliva', 'stimulated glandular salivary secretion rates and adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0242422', 'cui_str': 'Parkinsonism'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332301', 'cui_str': 'Radiating to'}, {'cui': 'C0030580', 'cui_str': 'Parotid gland structure'}, {'cui': 'C0038556', 'cui_str': 'Submandibular salivary apparatus'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0030580', 'cui_str': 'Parotid gland structure'}, {'cui': 'C0036098', 'cui_str': 'Salivary gland structure'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038556', 'cui_str': 'Submandibular salivary apparatus'}]","[{'cui': 'C0013132', 'cui_str': 'Dribbling from mouth'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0225353', 'cui_str': 'Glandular'}, {'cui': 'C0036104', 'cui_str': 'Salivary secretion'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",31.0,0.274495,"Parotid- and submandibular radiation was equally effective, but more patients in the submandibular radiated group reported sticky saliva vs. patients treated by parotid radiation (33∙33% vs. 13∙33%).
","[{'ForeName': 'R J H M', 'Initials': 'RJHM', 'LastName': 'Steenbakkers', 'Affiliation': 'Department of Radiotherapy, University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'van Doornik', 'Affiliation': 'Department of Dental Medicine, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vissink', 'Affiliation': 'Department of Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Kerdijk', 'Affiliation': 'Department of Dental Medicine, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'van Laar', 'Affiliation': 'Department of Neurology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB Groningen, the Netherlands.'}]",Clinical parkinsonism & related disorders,['10.1016/j.prdoa.2022.100138']
3260,35243305,Direction- and Angle-Assisted Buttonhole Cannulation of Arteriovenous Fistula in Hemodialysis Patients: A Multicenter Randomized Controlled Trial.,"Rationale & Objective


Arteriovenous fistula cannulation with the buttonhole technique is often preferred by patients but has been associated with an increased infection risk. Guidelines disagree on whether it should be abandoned, thus we assessed a technologically simple method to facilitate gentler arteriovenous fistula cannulation with potentially less discomfort and damage to the epithelial lining of the buttonhole tract.
Study Design


8-week, prospective, open-label, randomized controlled trial.
Setting & Participants


Patients with buttonhole tracts receiving hemodialysis at 7 dialysis centers in Norway were randomized to the intervention group (43 patients, 658 cannulations) or control group (40 patients, 611 cannulations).
Intervention


Direction and angle of the established buttonhole tract were marked on the forearm skin in the intervention group, whereas the control group had no structured cannulation information system.
Outcomes


The primary outcome was successful cannulation, defined as correct placement of both blunt needles at the first attempt without needing to change needles, perform extra perforations, or reposition the needle. The secondary outcomes were patient-reported difficulty of cannulation (verbal rating scale: 1 = very easy, 6 = impossible) and intensity of pain (numeric rating scale: 0 = no pain, 10 = unbearable pain).
Results


After a 2-week run-in period, successful cannulation was achieved in 73.9% and 74.8% of the patients in the intervention and control groups, respectively (relative risk [RR], 0.99; 95% CI, 0.87-1.12;  P  = 0.85). However, the probability of a difficult arterial cannulation (verbal rating scale, 3-6) was significantly lower in the intervention group (RR, 0.69; 95% CI, 0.55-0.85;  P  = 0.001). There were no improvements for venous cannulations. Furthermore, the probability of a painful cannulation (numeric rating scale, 3-10) was lower in the intervention group (RR, 0.72; 95% CI, 0.51-1.02;  P  = 0.06).
Limitations


Unable to evaluate hard end points such as infections and thrombosis owing to the small sample size.
Conclusions


Marking direction and angle of cannulation did not improve cannulation success rates; however, patients more often reported an unproblematic procedure and less pain.
Funding


None.
Trial Registration


ClinicalTrials.gov (NCT01536548).",2022,"Furthermore, the probability of a painful cannulation (numeric rating scale, 3-10) was lower in the intervention group (RR, 0.72; 95% CI, 0.51-1.02;  P  = 0.06).
","['Participants\n\n\nPatients with buttonhole tracts receiving hemodialysis at 7 dialysis centers in Norway were randomized to the intervention group (43 patients, 658 cannulations) or control group (40 patients, 611 cannulations', 'Hemodialysis Patients']",['Direction- and Angle-Assisted Buttonhole Cannulation of Arteriovenous Fistula'],"['patient-reported difficulty of cannulation (verbal rating scale: 1\xa0= very easy, 6\xa0= impossible) and intensity of pain (numeric rating scale: 0\xa0= no pain, 10\xa0= unbearable pain', 'successful cannulation, defined as correct placement of both blunt needles at the first attempt without needing to change needles, perform extra perforations, or reposition the needle', 'probability of a difficult arterial cannulation (verbal rating scale', 'venous cannulations', 'successful cannulation', 'probability of a painful cannulation (numeric rating scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0181962', 'cui_str': 'Blunt needle'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}]",,0.107695,"Furthermore, the probability of a painful cannulation (numeric rating scale, 3-10) was lower in the intervention group (RR, 0.72; 95% CI, 0.51-1.02;  P  = 0.06).
","[{'ForeName': 'Marit I', 'Initials': 'MI', 'LastName': 'Rønning', 'Affiliation': 'Department of Nephrology, St. Olav Hospital, Trondheim, Norway.'}, {'ForeName': 'Willem P', 'Initials': 'WP', 'LastName': 'Benschop', 'Affiliation': 'Department of Medicine, Innlandet Hospital, Lillehammer, Norway.'}, {'ForeName': 'Marius A', 'Initials': 'MA', 'LastName': 'Øvrehus', 'Affiliation': 'Department of Nephrology, St. Olav Hospital, Trondheim, Norway.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hultstrøm', 'Affiliation': 'Department of Nephrology, St. Olav Hospital, Trondheim, Norway.'}, {'ForeName': 'Stein I', 'Initials': 'SI', 'LastName': 'Hallan', 'Affiliation': 'Department of Nephrology, St. Olav Hospital, Trondheim, Norway.'}]",Kidney medicine,['10.1016/j.xkme.2021.10.006']
3261,35243302,"Long-Term Effects of Sevelamer on Vascular Calcification, Arterial Stiffness, and Calcification Propensity in Patients Receiving Peritoneal Dialysis: The Randomized Pilot SERENE (Sevelamer on Vascular Calcification, Arterial Stiffness) Trial.","Rationale & Objective


There is a concern regarding increased risk of vascular calcification with the use of calcium-based phosphorus binders. This study aimed to compare the effects of sevelamer used as a second-line, low-dose therapy with calcium-based phosphorus binders with those of sevelamer used as a first-line, high-dose therapy on coronary artery and heart valve calcification, aortic pulse wave velocity (PWV), and calcification propensity over 2 years in patients with hyperphosphatemia receiving peritoneal dialysis (PD).
Study Design


A 2-year-long prospective, multicenter, open-label, randomized pilot study.
Setting & Participants


Prevalent patients with hyperphosphatemia receiving PD from 2 university-affiliated hospitals in Hong Kong.
Interventions


The patients were randomized to receive sevelamer either as a first-line therapy at a high dose of 800 mg thrice daily (can titrate up to 1,200 mg thrice daily as required) or a second-line therapy at a low dose of 400 mg thrice daily with calcium carbonate to achieve a serum phosphorus target of ≤5.5 mg/dL.
Outcomes


The primary endpoints were changes in coronary artery calcium score and aortic PWV over 104 weeks. The secondary endpoints were changes in heart valve calcium scores, calcification propensity measure, and biochemical parameters of chronic kidney disease-mineral bone disease over 104 weeks.
Results


Among 60 prevalent patients receiving PD, with a mean age of 53 ± 10 years and with 57% men, changes in the coronary artery calcium score (median [interquartile range], 225 [79-525] vs 223 [56-1,212], respectively;  P  = 0.21), aortic PWV (mean ± standard error, 0.3 ± 0.1 vs 0.8 ± 0.2 m/s, respectively;  P  = 0.31), heart valve calcium score, maturation or transformation time, serum calcium levels, and phosphorus levels over 104 weeks were similar for the second-line, low-dose and first-line, high-dose sevelamer groups. Alkaline phosphatase and intact parathyroid hormone levels increased and low-density lipoprotein cholesterol decreased in both the groups, with no significant between-group differences.
Limitations


The sample size was small, and the dropout rates were relatively high.
Conclusions


Low-dose sevelamer used as a second-line therapy for hyperphosphatemia in combination with a calcium-based phosphorus binder had similar effects on vascular calcification, valvular calcification, and arterial stiffness compared with high-dose sevelamer used as a first-line therapy. This approach may be considered in resource-constrained countries to minimize calcium loading.
Funding


The study was supported by a competitive grant from SK Yee Medical Foundation. T50 assays and other biochemical assays were funded by a research grant from Sanofi Renal Corporation.
Trial Registration


NCT00745589.",2022,"Alkaline phosphatase and intact parathyroid hormone levels increased and low-density lipoprotein cholesterol decreased in both the groups, with no significant between-group differences.
","['patients with hyperphosphatemia receiving peritoneal dialysis (PD', 'Setting & Participants\n\n\nPrevalent patients with hyperphosphatemia receiving PD from 2 university-affiliated hospitals in Hong Kong', 'Patients Receiving Peritoneal Dialysis', 'mean\xa0±\xa0standard error, 0.3\xa0±\xa00.1 vs 0.8\xa0±\xa00.2\xa0m/s, respectively;  P \xa0=\xa00.31', '60 prevalent patients receiving PD, with a mean age of 53\xa0±\xa010 years and with 57% men']","['sevelamer', 'calcium-based phosphorus binders with those of sevelamer', 'Sevelamer', 'calcium carbonate to achieve a serum phosphorus target of\xa0≤5.5\xa0mg/dL.\nOutcomes']","['coronary artery calcium score and aortic PWV', 'Vascular Calcification, Arterial Stiffness, and Calcification Propensity', 'heart valve calcium scores, calcification propensity measure, and biochemical parameters of chronic kidney disease-mineral bone disease over 104 weeks', 'coronary artery calcium score', 'vascular calcification, valvular calcification, and arterial stiffness', 'coronary artery and heart valve calcification, aortic pulse wave velocity (PWV), and calcification propensity', 'Alkaline phosphatase and intact parathyroid hormone levels', 'low-density lipoprotein cholesterol', 'heart valve calcium score, maturation or transformation time, serum calcium levels, and phosphorus levels', 'aortic PWV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085681', 'cui_str': 'Hyperphosphatemia'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C4517447', 'cui_str': '0.31'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0718050', 'cui_str': 'sevelamer'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C2825178', 'cui_str': 'Coronary artery calcium score'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0005940', 'cui_str': 'Disorder of bone'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1142152', 'cui_str': 'Heart valve calcification'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}]",,0.0209192,"Alkaline phosphatase and intact parathyroid hormone levels increased and low-density lipoprotein cholesterol decreased in both the groups, with no significant between-group differences.
","[{'ForeName': 'Angela Yee-Moon', 'Initials': 'AY', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pasch', 'Affiliation': 'Institute for Physiology and Pathophysiology, Johannes Kepler University Linz, Linz, Austria.'}, {'ForeName': 'Chun-Kwok', 'Initials': 'CK', 'LastName': 'Wong', 'Affiliation': 'Department of Chemical Pathology, Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Ida Miu-Ting', 'Initials': 'IM', 'LastName': 'Chu', 'Affiliation': 'Department of Chemical Pathology, Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Tak-Ka', 'Initials': 'TK', 'LastName': 'Tang', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Chu', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Charmaine', 'Initials': 'C', 'LastName': 'Cheuk-Ying Fong', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Yat-Yin', 'Initials': 'YY', 'LastName': 'Yau', 'Affiliation': 'Precision Health & Diagnostic Centre Ltd, Hong Kong SAR, China.'}, {'ForeName': 'Wai-Kei', 'Initials': 'WK', 'LastName': 'Lo', 'Affiliation': 'Department of Medicine, Tung Wah Hospital, The University of Hong Kong, Hong Kong SAR, China.'}]",Kidney medicine,['10.1016/j.xkme.2021.10.002']
3262,35243301,"Dialysate Magnesium and Coronary Artery Calcification, Bone Mineral Density, and Cramping in Maintenance Hemodialysis: A Quasi-experimental Study.","Rationale & Objective


Recent evidence suggests a role for magnesium as a calcification inhibitor. Increased magnesium abundance may attenuate vascular calcification and promote bone formation.
Study Design


Parallel-group, 1:1-allocation-ratio, quasi-experimental study.
Setting & Participants


The study was conducted at hemodialysis centers in Bangkok, Thailand. Patients receiving maintenance hemodialysis were screened for coronary artery calcification (CAC) and bone mineral density (BMD), and those with a CAC score of ≥300 were included and matched according to the initial CAC score. The intervention and control groups consisted of 20 patients in each arm.
Interventions


A high (1.75 mEq/L) or standard (0.7 mEq/L) dialysate magnesium concentration was delivered for 26 weeks.
Outcomes


Changes in the CAC score and BMD and the progression of CAC. The safety outcomes included occurrence of cramps recorded as per usual care.
Results


The median CAC score of all patients was 1,792. Serum and ionized magnesium concentrations increased substantially in the high dialysate magnesium group. At the end of the study, the CAC score increased significantly in both the groups, with no significant difference between the groups. The number of participants with CAC progression was comparable between the 2 groups. In exploratory subgroup analyses stratified by the median CAC score, a significant decline in CAC and fewer participants with CAC progression were observed in the subgroup with lower CAC scores that received the high dialysis magnesium concentration. Bone mineral density was largely unchanged in both groups. The number of participants experiencing cramps and the number of episodes of muscle cramps were markedly lower among patients who received the high dialysis magnesium concentration.
Limitations


The participants had severe vascular calcification at baseline; therefore, the findings might not apply to those with less-established calcification. Moreover, cramps were not systematically ascertained.
Conclusions


The high dialysis magnesium concentration did not alleviate the progression of CAC or improve BMD in patients with severe calcification receiving hemodialysis; however, muscle cramps were less frequent among those treated with high dialysate magnesium. Further study is required to determine a possible favorable effect of high dialysis magnesium concentration in individuals with mild-to-moderate calcification.",2022,"The number of participants experiencing cramps and the number of episodes of muscle cramps were markedly lower among patients who received the high dialysis magnesium concentration.
","['Maintenance Hemodialysis', 'Setting & Participants', 'individuals with mild-to-moderate calcification', 'patients with severe calcification receiving hemodialysis', 'hemodialysis centers in Bangkok, Thailand', 'Patients receiving maintenance hemodialysis were screened for coronary artery calcification (CAC) and bone mineral density (BMD), and those with a CAC score of\xa0≥300 were included and matched according to the initial CAC score']",[],"['Serum and ionized magnesium concentrations', 'cramps', 'median CAC score', 'Dialysate Magnesium and Coronary Artery Calcification, Bone Mineral Density, and Cramping', 'number of participants experiencing cramps and the number of episodes of muscle cramps', 'progression of CAC or improve BMD', 'number of participants with CAC progression', 'severe vascular calcification', 'Bone mineral density', 'CAC score and BMD and the progression of CAC', 'muscle cramps', 'CAC score', 'occurrence of cramps recorded as per usual care']","[{'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0369643', 'cui_str': 'Magnesium electrolyte'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]",,0.129146,"The number of participants experiencing cramps and the number of episodes of muscle cramps were markedly lower among patients who received the high dialysis magnesium concentration.
","[{'ForeName': 'Praopilad', 'Initials': 'P', 'LastName': 'Srisuwarn', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sethanant', 'Initials': 'S', 'LastName': 'Sethakarun', 'Affiliation': 'Bhumirajanagarindra Kidney Institute, Bangkok, Thailand.'}, {'ForeName': 'Arkom', 'Initials': 'A', 'LastName': 'Nongnuch', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sutipong', 'Initials': 'S', 'LastName': 'Jongjirasiri', 'Affiliation': 'Department of Radiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chanika', 'Initials': 'C', 'LastName': 'Sritara', 'Affiliation': 'Division of Nuclear Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pinkeaw', 'Initials': 'P', 'LastName': 'Klyprayong', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sinee', 'Initials': 'S', 'LastName': 'Disthabanchong', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Kidney medicine,['10.1016/j.xkme.2021.08.009']
3263,35243636,"The effect of bolus size on masticatory parameters at swallowing threshold in children using a hard, solid, artificial test food.","The effect of different bolus sizes on food breakdown has been studied in adults, but not in children. The objective of this study was to study median particle size (MPS) and other parameters of masticatory function at swallowing threshold (ST) in 8-10-year-old-children with two different bolus sizes. A randomized cross-over trial was undertaken in 89 eight to ten-year-old children. The study was performed with informed consent and ethical approval. The artificial test food used was made of a condensation silicone (Optosil Comfort®) following a standardized protocol. Two bolus sizes (three or four quarters of a 20 mm diameter, 5 mm thick tablet) were randomized to avoid an order effect and performed in different sessions. Variables were: MPS (X 50  ) at ST, number of cycles until ST, sequence and cycle duration as well as cycles/g. Comparisons were performed with paired-T and Wilcoxon-tests, regressions and correlations were run. Cutoff for statistical significance was .05. Statistically significant differences were found for all variables; X 50  (2.5±.8 vs 2.8±.7mm, p<.001), cycles until ST (38 vs 40, p=.022), sequence (25 vs 27 seconds, p=.003) and cycle duration (650 vs 683 ms, p=.015) and cycles/g (27 vs 21 cycles/gram, p<.001), three or four quarters respectively. In conclusion, in children, as in adults, chewing on a bigger bolus size leads to a larger MPS (X 50  ) at ST. When chewing on a larger bolus the number of cycles increases, but not enough to swallow the same particle size since the number of cycles/g is less with a bigger bolus size.",2022,"Statistically significant differences were found for all variables; X 50  (2.5±.8 vs 2.8±.7mm, p<.001), cycles until ST (38 vs 40, p=.022), sequence (25 vs 27 seconds, p=.003) and cycle duration (650 vs 683 ms, p=.015) and cycles/g (27 vs 21 cycles/gram, p<.001), three or four quarters respectively.","['children using a hard, solid, artificial test food', '89 eight to ten-year-old children', '8-10-year-old-children with two different bolus sizes']","['masticatory function at swallowing threshold (ST', 'condensation silicone (Optosil Comfort®']","['median particle size (MPS', 'cycle duration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0456389', 'cui_str': 'Size'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0233656', 'cui_str': 'Mental condensation'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0134027', 'cui_str': 'Optosil'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030608', 'cui_str': 'Particle Size'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0791403,"Statistically significant differences were found for all variables; X 50  (2.5±.8 vs 2.8±.7mm, p<.001), cycles until ST (38 vs 40, p=.022), sequence (25 vs 27 seconds, p=.003) and cycle duration (650 vs 683 ms, p=.015) and cycles/g (27 vs 21 cycles/gram, p<.001), three or four quarters respectively.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Wintergerst', 'Affiliation': 'Graduate School of Dentistry, Universidad Nacional Autónoma de México, México City, México.'}, {'ForeName': 'Roberto Samuel', 'Initials': 'RS', 'LastName': 'Gómez-Zúñiga', 'Affiliation': 'Graduate School of Dentistry, Universidad Nacional Autónoma de México, México City, México.'}]",Journal of texture studies,['10.1111/jtxs.12671']
3264,35243631,Randomized experiment on the effect of incentives and mailing strategy on response rates in a mail survey of dentists.,"OBJECTIVES


Response rates for mail surveys of dentists and other health care providers have declined appreciably over the past several decades. The objective of this study was to update evidence about the impact use of incentives and different mail strategies on response rates in a mail survey of dentists.
METHODS


We randomized private practice dentists in Iowa (N = 1267) into six study groups to test the effects of incentives and mail strategy on response rate. Survey incentives included either a $2 bill or a customized pen/stylus; a control group with no incentive was included. Mail strategies included bulk mail or first-class stamps.
RESULTS


The overall survey response rate was 43%. A $2 bill incentive was associated with significantly higher likelihood of returning a survey compared to the control group with no incentive (48% response rate vs. 40%, respectively). A non-monetary incentive was not significantly associated with likelihood of response. Use of first-class stamps compared to bulk mail did not significantly affect response rate.
CONCLUSIONS


This study demonstrated the effectiveness of a $2 incentive to increase response rate in a mail survey of dentists. Given the background trend of declining survey participation rates, researchers should consider use of monetary incentives and explore new strategies to increase participation among dentists and other health care providers.",2022,"A $2 bill incentive was associated with significantly higher likelihood of returning a survey compared to the control group with no incentive (48% response rate vs. 40%, respectively).","['mail surveys of dentists and other health care providers', 'mail survey of dentists']",['incentives and mailing strategy'],"['response rates', 'response rate', 'overall survey response rate']","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0024492', 'cui_str': 'Mail'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",1267.0,0.0293195,"A $2 bill incentive was associated with significantly higher likelihood of returning a survey compared to the control group with no incentive (48% response rate vs. 40%, respectively).","[{'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'McKernan', 'Affiliation': 'Department of Preventive and Community Dentistry, University of Iowa College of Dentistry and Dental Clinics, Iowa City, Iowa, USA.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Reynolds', 'Affiliation': 'Department of Preventive and Community Dentistry, University of Iowa College of Dentistry and Dental Clinics, Iowa City, Iowa, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'McInroy', 'Affiliation': 'University of Iowa Public Policy Center, Iowa City, Iowa, USA.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Damiano', 'Affiliation': 'Department of Preventive and Community Dentistry, University of Iowa College of Dentistry and Dental Clinics, Iowa City, Iowa, USA.'}]",Journal of public health dentistry,['10.1111/jphd.12510']
3265,35243620,Childhood trauma and treatment outcomes during mood-stabilising treatment with lithium or quetiapine among outpatients with bipolar disorder.,"BACKGROUND


Childhood trauma affects the course of mood disorders. Researchers are now considering childhood trauma as an influential factor in the treatment of mood disorders. However, the role of childhood trauma in the treatment of bipolar disorder remains understudied.
METHODS


The effect of childhood trauma on treatment outcomes was evaluated among participants randomised to treatment with lithium or quetiapine in the Clinical and Health Outcomes Initiatives in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE) study by clinician assessment. Mixed effects linear regression models were used to analyse rates of improvement in symptom severity (assessed with the Bipolar Inventory of Symptoms Scale and the Clinical Global Impression Scale for Bipolar Disorder) and functional impairment (assessed with the Longitudinal Interval Follow-up Evaluation-Range of Impaired Functioning Tool).
RESULTS


A history of any childhood trauma was reported by 52.7% of the sample (N = 476). Although participants with a history of any childhood trauma presented with greater symptom severity and functional impairment at most study visits, participants with and without a history of any childhood trauma showed similar rates of improvement in symptom severity and functional impairment over the 24 weeks of treatment.
CONCLUSION


This is the first study to explore the association between childhood trauma and treatment outcomes during treatment with lithium or quetiapine in the context of a randomised trial. In Bipolar CHOICE, a history of childhood trauma did not inhibit improvement in symptom severity or functional impairment. Nevertheless, these findings need replication across different settings.",2022,"In Bipolar CHOICE, a history of childhood trauma did not inhibit improvement in symptom severity or functional impairment.","['outpatients with bipolar disorder', 'participants with a history of any childhood trauma']",['lithium or quetiapine'],"['symptom severity (assessed with the Bipolar Inventory of Symptoms Scale and the Clinical Global Impression Scale for Bipolar Disorder) and functional impairment', 'symptom severity and functional impairment', 'symptom severity or functional impairment']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",476.0,0.0711037,"In Bipolar CHOICE, a history of childhood trauma did not inhibit improvement in symptom severity or functional impairment.","[{'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Wrobel', 'Affiliation': 'IMPACT - The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Köhler-Forsberg', 'Affiliation': 'Psychosis Research Unit, Aarhus University Hospital Psychiatry, Denmark.'}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Russell', 'Affiliation': 'IMPACT - The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Dean', 'Affiliation': 'IMPACT - The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Cotton', 'Affiliation': 'Orygen, Parkville, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'University of Applied Sciences, Diploma Hochschule, Germany.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Tohen', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Science Center, Albuquerque, NM, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Bowden', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kocsis', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Friedman', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Terence A', 'Initials': 'TA', 'LastName': 'Ketter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ostacher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'NYU School of Medicine and Nathan Kline Institute, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'IMPACT - The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Alyna', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'IMPACT - The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13420']
3266,35243614,Reading with induced worry: The role of physiological self-regulation and working memory updating in text comprehension.,"BACKGROUND


An interplay of emotional and cognitive aspects underlies academic performance. We focused on the contribution of such interplay to text comprehension.
AIMS


We investigated the effect of worry on comprehension and the role of two potential moderators of this effect: physiological self-regulation as resting heart rate variability (HRV) and working memory updating.
SAMPLE


Eighty-two seventh graders were involved in a quasi-experimental design.
METHODS


Students read an informational text in one of two reading conditions: to read for themselves to know more (n = 46; low-worry condition) or to gain the highest score in a ranking (n = 36; high-worry condition). Students' resting HRV was recorded while watching a video of a natural scenario. The executive function of working memory updating was also assessed. After reading, students completed a comprehension task.
RESULTS


Findings revealed the moderating role of HRV in the relationship between induced worry and text comprehension. In the high-worry condition, students with higher resting HRV performed better than students who read under the same instructions but had lower HRV. In contrast, in the low-worry condition, students with higher resting HRV showed a lower performance as compared to students with lower HRV. Finally, working memory updating was positively related to text comprehension.
CONCLUSIONS


Our findings indicate that the cognitive component of anxiety, that is, worry, plays a role in performing a fundamental learning activity like text comprehension. The importance of physiological self-regulation emerges clearly. In a condition of high worry, higher ability to regulate emotions and thoughts acts as a protective factor.",2022,"In the high-worry condition, students with higher resting HRV performed better than students who read under the same instructions but had lower HRV.",['Students read an informational text in one of two reading conditions: to read for themselves to know more (n\u2009=\u200946; low-worry condition) or to gain the highest score in a ranking (n\u2009=\u200936; high-worry condition'],[],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205172', 'cui_str': 'More'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}]",[],[],82.0,0.0228665,"In the high-worry condition, students with higher resting HRV performed better than students who read under the same instructions but had lower HRV.","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Zaccoletti', 'Affiliation': 'Department of Developmental Psychology and Socialization, University of Padua, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Raccanello', 'Affiliation': 'Department of Human Sciences, University of Verona, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Burro', 'Affiliation': 'Department of Human Sciences, University of Verona, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mason', 'Affiliation': 'Department of Developmental Psychology and Socialization, University of Padua, Italy.'}]",The British journal of educational psychology,['10.1111/bjep.12491']
3267,35243909,Can body awareness training improve recovery following stroke: A study to assess feasibility and preliminary efficacy.,"BACKGROUND


Impairments in body awareness are common after stroke and are associated with decreased participation and performance in everyday activities.
OBJECTIVES


To explore the feasibility and safety of a body awareness program after stroke, and identify the preliminary efficacy of class-based lessons compared to home-based lessons on sensation, body awareness, motor impairment and quality of life.
METHODS


A two-armed pilot randomized controlled trial with a nested qualitative descriptive study was conducted. Individuals with a diagnosis of stroke (at least three months post injury) were randomized to either class-based face-to-face body awareness lessons or home-based individually performed body awareness lessons. Outcome measures were safety, feasibility, sensation, body awareness, motor impairment, self-efficacy and quality of life. Semi-structured interviews were used to allow greater exploration and understanding of participants' experience of the program.
RESULTS


Twenty participants were randomized, 16 participants completed the program. Feasibility was greater in the class-based group. No adverse events were detected. The class-based group led to improvement in body awareness (p = 0.002), quality of life (p = 0.002), and the arm (p = 0.025) and leg (p = 0.005) motor impairment scores.  Qualitative data similarly indicated that  the class-based group experienced a stronger sense of awareness, achievement and connection than the home-based group.
CONCLUSIONS


Body awareness training was safe, feasible and acceptable in people with stroke. Individuals in the class-based group showed greater benefit compared to those receiving home-based therapy.",2022,"The class-based group led to improvement in body awareness (p = 0.002), quality of life (p = 0.002), and the arm (p = 0.025) and leg (p = 0.005) motor impairment scores.  ","['Twenty participants were randomized, 16 participants completed the program', 'people with stroke', 'Individuals with a diagnosis of stroke (at least three months post injury']","['Body awareness training', 'class-based face-to-face body awareness lessons or home-based individually performed body awareness lessons']","['Feasibility', 'sensation, body awareness, motor impairment and quality of life', 'safety, feasibility, sensation, body awareness, motor impairment, self-efficacy and quality of life', 'adverse events', 'quality of life', 'body awareness']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",20.0,0.0150898,"The class-based group led to improvement in body awareness (p = 0.002), quality of life (p = 0.002), and the arm (p = 0.025) and leg (p = 0.005) motor impairment scores.  ","[{'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Serrada', 'Affiliation': 'Allied Health and Human Performance, Innovation, Implementation and Clinical Translation (IIMPACT) in Health, 1067University of South Australia, City East Campus, Adelaide SA 5000, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fryer', 'Affiliation': 'Allied Health and Human Performance, Innovation, Implementation and Clinical Translation (IIMPACT) in Health, 1067University of South Australia, City East Campus, Adelaide SA 5000, Australia.'}, {'ForeName': 'Brenton', 'Initials': 'B', 'LastName': 'Hordacre', 'Affiliation': 'Allied Health and Human Performance, Innovation, Implementation and Clinical Translation (IIMPACT) in Health, 1067University of South Australia, City East Campus, Adelaide SA 5000, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hillier', 'Affiliation': 'Allied Health and Human Performance, Innovation, Implementation and Clinical Translation (IIMPACT) in Health, 1067University of South Australia, City East Campus, Adelaide SA 5000, Australia.'}]",Clinical rehabilitation,['10.1177/02692155221083492']
3268,35243901,LASER-INDUCED OCULAR LESIONS WITH THULIUM FIBER LASER IN ENDOUROLOGY : AN EX VIVO STUDY.,"INTRODUCTION AND OBJECTIVES


The Thulium Fiber Laser(Tm-F) is currently studied as an alternative to the Holmium:YAG laser(Ho:YAG), the gold-standard for endocorporeal laser lithotripsy. We aimed to evaluate the ex vivo effects of an accidental Tm-F laser exposure on bovine eyes and to test the protective action of different eyeglasses in preventing eye lesions in case of accident.
METHODS


A 50W-TFL-generator(IPG Photonics®, Russia) with a wavelength of 1940nm and 200µm-core-diameter-fibers(CDF) were used. The laser fiber tip was pointed perpendicularly at different distances(0, 1, 3, 5, 8, 10, respectively) to the pupil center of the bovine eye. The Tm-F laser was activated for 1 or 3 seconds at three different settings(0.5J-20Hz, 1J-10Hz, and 2J-10Hz, respectively). The experiment was repeated using laser safety glasses and eyeglasses. After lasering, eye samples were immersed in a 0,5 % fluorescein serum (Faure-Ciba-Geigy®, Switzerland), then rinsed with saline solution. White- and blue-light examinations looked for localized epithelial burns(LEB), extended epithelial burns(EEB), superficial corneal ulcerations(SCU) and deep corneal ulcerations(DCU).
RESULTS


A total of 68 bovine eyes were used. Despite the laser settings, both DCU(contact) and SCU (1cm) developed without eye protection, for 1 and 3 seconds of lasering. At 3cm fiber-eye distance, only burning lesions were observed. Over 5cm, no lesion was found. At contact or 1 cm fiber-eye distance, pulse energy did not change lesion grade, but at 3cm, high pulse energy led to higher grade corneal lesions(0,5J-10Hz:LEB; 1J-10Hz:EEB). Despite the fiber-eye distance, no corneal lesions were reported in the laser safety glasses or eyeglasses groups for 1 second laser exposure.
CONCLUSION


Our study highlights the risk of eye damage caused by Tm-F. Without proper eye protection Tm-F can cause corneal lesions up to 5cm in distance for 1 second of exposure, despite laser settings. Only dedicated protective eyeglasses are effective for long exposures.",2022,"Despite the fiber-eye distance, no corneal lesions were reported in the laser safety glasses or eyeglasses groups for 1 second laser exposure.
","['A 50W-TFL-generator(IPG Photonics®, Russia) with a wavelength of 1940nm and 200µm-core-diameter-fibers(CDF', '68 bovine eyes']","['Tm-F', 'accidental Tm-F laser exposure', 'LASER-INDUCED OCULAR LESIONS WITH THULIUM FIBER LASER IN ENDOUROLOGY ']",[],"[{'cui': 'C1328817', 'cui_str': 'Photonics'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0000924', 'cui_str': 'Accident'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",[],68.0,0.0158967,"Despite the fiber-eye distance, no corneal lesions were reported in the laser safety glasses or eyeglasses groups for 1 second laser exposure.
","[{'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Panthier', 'Affiliation': 'Sorbonne Universite, 27063, GRC n°20, Groupe de Recherche Clinique sur la Lithiase Urinaire, Hôpital Tenon, Sorbonne Université, 75020, Paris, France., Paris, Île-de-France, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chiron', 'Affiliation': 'Hôpital Tenon, Urology, Paris, France; p.chiron@laposte.net.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Gorny', 'Affiliation': 'Process and Engineering in Mechanics and Materials laboratory (PIMM), UMR CNRS/ENSAM 8006, Paris, France; cyril.gorny@ensam.eu.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Berthe', 'Affiliation': 'Process and Engineering in Mechanics and Materials laboratory (PIMM), UMR CNRS/ENSAM 8006, Paris, France; laurent.berthe@ensam.eu.'}, {'ForeName': 'Steeve', 'Initials': 'S', 'LastName': 'Doizi', 'Affiliation': 'Tenon Hospital, Assistance-Publique Hôpitaux de Paris, Urology, 4 rue de la Chine, Paris, France, 75020; steeve.doizi@aphp.fr.'}, {'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Corrales', 'Affiliation': 'Hospital Tenon, 55705, Urology, 4 Rue de la Chine, Paris, Île-de-France, France, 75020; mariela_corrales_a@hotmail.com.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Traxer', 'Affiliation': 'Tenon Hospital, Assitance Publique-Hopitaux De Paris. Pierre Et Marie Curie University, Paris 6, Urology, 4 rue de la Chine, Paris, France, 75020; olivier.traxer@aphp.fr.'}]",Journal of endourology,['10.1089/end.2021.0948']
3269,35243875,Effect of Time to Treatment With Antiarrhythmic Drugs on Return of Spontaneous Circulation in Shock-Refractory Out-of-Hospital Cardiac Arrest.,"Background The effects of amiodarone and lidocaine on the return of spontaneous circulation (ROSC) in relation to time to treatment in patients with out-of-hospital cardiac arrest is not known. We conducted a post hoc analysis of the ROC ALPS (Resuscitation Outcomes Consortium Amiodarone, Lidocaine, Placebo) randomized controlled trial examining the association of time to treatment (drug or placebo) with ROSC at hospital arrival. Methods and Results In the trial, adults with nontraumatic out-of-hospital cardiac arrest with initial refractory ventricular fibrillation or pulseless ventricular tachycardia after at least 1 defibrillation were randomly assigned to receive amiodarone, lidocaine, or placebo. We used logistic regression to examine the association of time to treatment (911 call to study drug administration) with ROSC. An interaction term between treatment and time to treatment was included to determine the potential effect of time on treatment effects. Overall, 1112 (36.7%) patients had ROSC at hospital arrival (350 in the amiodarone arm, 396 in the lidocaine arm, and 366 in the placebo arm). The proportion of patients who had ROSC decreased as time to drug administration increased, in patients treated with amiodarone (odds ratio, 0.92; 95% CI, 0.90-0.94 per minute increase), lidocaine (odds ratio, 0.95; 95% CI, 0.93-0.96), and placebo (odds ratio, 0.95; 95% CI, 0.93-0.96). With shorter times to drug administration, the proportion with ROSC was higher in amiodarone versus placebo recipients. Conclusions The probability of ROSC decreased as time to drug administration increased. The effect of amiodarone but not lidocaine to restore ROSC declined with longer times to drug administration, potentially attributable to its adverse hemodynamic effects.",2022,"The proportion of patients who had ROSC decreased as time to drug administration increased, in patients treated with amiodarone (odds ratio, 0.92; 95% CI, 0.90-0.94 per minute increase), lidocaine (odds ratio, 0.95; 95% CI, 0.93-0.96), and placebo (odds ratio, 0.95; 95% CI, 0.93-0.96).","['Shock-Refractory Out-of-Hospital Cardiac Arrest', 'patients with out-of-hospital cardiac arrest', 'adults with nontraumatic out-of-hospital cardiac arrest with initial refractory ventricular fibrillation or pulseless ventricular tachycardia after at least 1 defibrillation']","['ROSC', 'lidocaine', 'placebo', 'amiodarone and lidocaine', 'Antiarrhythmic Drugs', 'amiodarone', 'Amiodarone, Lidocaine, Placebo', 'amiodarone, lidocaine, or placebo']","['ROSC', 'probability of ROSC', 'ROSC at hospital arrival', 'time to drug administration', 'restore ROSC', 'proportion with ROSC', 'return of spontaneous circulation (ROSC']","[{'cui': 'C0349412', 'cui_str': 'Refractory shock'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}, {'cui': 'C0750196', 'cui_str': 'Pulseless ventricular tachycardia'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}]",,0.216147,"The proportion of patients who had ROSC decreased as time to drug administration increased, in patients treated with amiodarone (odds ratio, 0.92; 95% CI, 0.90-0.94 per minute increase), lidocaine (odds ratio, 0.95; 95% CI, 0.93-0.96), and placebo (odds ratio, 0.95; 95% CI, 0.93-0.96).","[{'ForeName': 'Mahbod', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'Faculty of Medicine Institutes of Medical ScienceUniversity of Toronto Ontario Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorian', 'Affiliation': 'Faculty of Medicine Institutes of Medical ScienceUniversity of Toronto Ontario Canada.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Cheskes', 'Affiliation': 'Faculty of Medicine Institutes of Medical ScienceUniversity of Toronto Ontario Canada.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Lebovic', 'Affiliation': 'Institute of Health Policy, Management and EvaluationDalla Lana School of Public HealthUniversity of Toronto Ontario Canada.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Faculty of Medicine Institutes of Medical ScienceUniversity of Toronto Ontario Canada.'}]",Journal of the American Heart Association,['10.1161/JAHA.121.023958']
3270,35243855,The step-up protocol increases clinical pregnancy rates compared with the step-down in patients with unexplained infertility. A randomized controlled trial.,"OBJECTIVE


Unexplained infertility is a relevant indication for controlled ovarian stimulation associated to intrauterine insemination. The ""step-up"" and ""step-down"" gonadotropin-based protocols were designed to reduce multiple pregnancy and ovarian hyperstimulation syndrome in polycystic ovary syndrome patients, but there is no related evidence in normoovulatory women undergoing intrauterine insemination. Our aim was to compare the efficacy and safety of both protocols with intrauterine insemination in unexplained infertility patients.
METHODS


Randomized clinical trial including 145 women with unexplained infertility randomly following the step-up (n=73) or step-down (n=72) protocol. In the step-up group, patients started on day 3 of a spontaneous cycle administrating recombinant FSH 75IU sc/day, increasing it to 150IU if no response after 7 days. In the step-down, patients started administrating 150IU sc/day, constantly decreasing it to 75IU after 5 days. Recombinant hCG was administered when a follicle reached ≥18mm diameter.
RESULTS


Clinical pregnancy rate was higher in the step-up group than in the step-down (20.5% vs . 8.3%; p =0.037). Significant differences between step-up and step-down protocols were found regarding days of rFSH administration (8.83±4.01% vs . 7.42±2.18%; p =0.001) and cancellation rate due to hyper response (8.21% vs . 25%; p =0.05). No differences were detected in miscarriage rates, multiple pregnancy rates/cycle and hyper stimulation syndrome incidence.
CONCLUSIONS


The step-up protocol is longer-lasting but more effective obtaining pregnancies than the step-down in patients with unexplained infertility undergoing intrauterine insemination. This effect could be explained by lower cancellation rates due to ovarian hyper response than the step-down protocol, with no differences in ovarian hyper stimulation syndrome incidence.",2022,The step-up protocol is longer-lasting but more effective obtaining pregnancies than the step-down in patients with unexplained infertility undergoing intrauterine insemination.,"['polycystic ovary syndrome patients', 'unexplained infertility patients', 'patients with unexplained infertility', 'normoovulatory women undergoing intrauterine insemination', '145 women with unexplained infertility randomly following the step-up (n=73) or step-down (n=72) protocol', 'patients with unexplained infertility undergoing intrauterine insemination']","['step-up"" and ""step-down"" gonadotropin-based protocols', 'Recombinant hCG', 'intrauterine insemination']","['Clinical pregnancy rate', 'clinical pregnancy rates', 'cancellation rate due to hyper response', 'efficacy and safety', 'multiple pregnancy and ovarian hyperstimulation syndrome', 'miscarriage rates, multiple pregnancy rates/cycle and hyper stimulation syndrome incidence']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032989', 'cui_str': 'Multiple pregnancy'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",145.0,0.22009,The step-up protocol is longer-lasting but more effective obtaining pregnancies than the step-down in patients with unexplained infertility undergoing intrauterine insemination.,"[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Robles', 'Affiliation': 'Reproductive Endocrinology Unit. Department of Obstetrics and Gynecology. Hospital del Mar de Barcelona. Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Gayete-Lafuente', 'Affiliation': 'Reproductive Endocrinology Unit. Department of Obstetrics and Gynecology. Hospital del Mar de Barcelona. Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Prat', 'Affiliation': 'Reproductive Endocrinology Unit. Department of Obstetrics and Gynecology. Hospital del Mar de Barcelona. Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Gonzalez-Comadran', 'Affiliation': 'Reproductive Endocrinology Unit. Department of Obstetrics and Gynecology. Hospital del Mar de Barcelona. Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Checa', 'Affiliation': 'Reproductive Endocrinology Unit. Department of Obstetrics and Gynecology. Hospital del Mar de Barcelona. Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.'}]",JBRA assisted reproduction,['10.5935/1518-0557.20210112']
3271,35244227,Parents' Priorities and Preferences for Treatment of Children with ADHD: Qualitative Inquiry in the MADDY Study.,"BACKGROUND


Parents' lived experiences of having a child with ADHD may shape their decision-making regarding ADHD treatment options for their child. The aim of this study was to explore parents' experiences of living with a child with ADHD in the family and how their experiences influence their perspectives on treatment preferences and priorities.
METHODS


A phenomenological qualitative design was used. Semi-structured interviews were conducted with parents of children with ADHD who were enrolled in a multi-site randomized controlled trial. Interviews were transcribed verbatim and transcripts at each site were double-coded. Initial codes were derived directly from the text. Qualitative data were analyzed with an inductive approach.
RESULTS


Twenty-three parents were interviews: eight from Alberta, Canada; eight from Portland, Oregon, U.S.; and seven from Columbus, Ohio, U.S. Among the parents, 69% were married, 86% were completed college education, and 52% reported household income over $80,000. Among the children, the mean age was 9.6 years (SD=1.8 years), 78% were boys, and 48% were never medicated for their ADHD. Two major themes emerged from the analysis. Theme one was ""Impact of ADHD on families within and outside the home"" with the following subthemes: ""Reconfiguring the home life"", ""Trial-and-error of accommodations at school"", and ""Responding to social pressures to fit-in"". Theme two was ""Enabling appropriate and accessible treatments for families"" with the following subthemes: ""Finding the 'right fit' with professionals and treatments"" and ""Factors influencing inequitable access to treatments"".
CONCLUSIONS


Parents described shared experiences and identified similar barriers, preferences, and priorities for ADHD treatments regardless of demographic differences by site. Families desired access to family-centered, multimodal approaches to ADHD treatment. Further research is needed to identify the specific structural changes to healthcare, services, and policies that will better support this approach.",2022,Semi-structured interviews were conducted with parents of children with ADHD who were enrolled in a multi-site randomized controlled trial.,"['children, the mean age was 9.6 years (SD=1.8 years), 78% were boys, and 48% were never medicated for their ADHD', ""Parents' lived experiences of having a child with ADHD"", 'Among the parents, 69% were married, 86% were completed college education, and 52% reported household income over $80,000', 'Semi-structured interviews were conducted with parents of children with ADHD who were enrolled in a multi-site randomized controlled trial', 'Twenty-three parents were interviews: eight from Alberta, Canada; eight from Portland, Oregon, U.S.; and seven from Columbus, Ohio, U.S', 'Children with ADHD', ""parents' experiences of living with a child with ADHD""]",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]",[],[],23.0,0.0560847,Semi-structured interviews were conducted with parents of children with ADHD who were enrolled in a multi-site randomized controlled trial.,"[{'ForeName': 'Stacy V', 'Initials': 'SV', 'LastName': 'Lu', 'Affiliation': 'Department of Population, Family, and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Brenda M Y', 'Initials': 'BMY', 'LastName': 'Leung', 'Affiliation': 'Faculty of Health Sciences, University of Lethbridge, Lethbridge, AB, Canada.'}, {'ForeName': 'Alisha M', 'Initials': 'AM', 'LastName': 'Bruton', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Millington', 'Affiliation': 'Faculty of Health Sciences, University of Lethbridge, Lethbridge, AB, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Alexander', 'Affiliation': 'Department of Human Sciences, College of Education and Human Ecology, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Camden', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hatsu', 'Affiliation': 'Department of Human Sciences, College of Education and Human Ecology, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Johnstone', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'Department of Psychiatry and Behavioral Health, The Ohio State University, Columbus, OH, USA.'}]","Child: care, health and development",['10.1111/cch.12995']
3272,35244153,What is a high-quality randomized controlled trial?,,2022,,[],[],[],[],[],[],,0.525528,,"[{'ForeName': 'Wesley S', 'Initials': 'WS', 'LastName': 'Warner', 'Affiliation': 'Department of Neurosurgery, Clinical Neurosciences Center, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Mahan', 'Affiliation': 'Department of Neurosurgery, Clinical Neurosciences Center, University of Utah, Salt Lake City, Utah.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnac040']
3273,35244070,"A comparative study of a nerve block therapy with and without a deeply inserted acupotomy applied to hyeopcheok points for lumbosacral radiculopathy: Safety, effectiveness, cost-effectiveness (a randomized controlled, two-arm, parallel study, pilot study, assessor-blind).","INTRODUCTION


The prevalence of lumbosacral radiculopathy is estimated to be approximately 3% to 5% in patient populations. Lumbosacral radiculopathy is largely caused by a complex interaction between biomechanical and biochemical factors. Nerve block therapy (NBT) mainly treats lumbosacral radiculopathy by improving the biochemical factors, whereas acupotomy mainly focuses on improving the biomechanical factors. Therefore, it is thought that synergistic effects may be obtained for the treatment of lumbosacral radiculopathy when both NBT and acupotomy are combined. However, no study in China and Korea, where acupotomy is majorly provided, has reported the effects of such a combination treatment. Therefore, this study aimed to evaluate the safety, effectiveness, and cost-effectiveness of the concurrent use of a deeply inserted acupotomy and NBT for the treatment of lumbosacral radiculopathy.
METHODS/DESIGN


This is an open-label, parallel, assessor-blinded, randomized controlled trial, which will include 50 patients with lumbosacral radiculopathy. After patients voluntarily agree to participate in the study, they will be screened, and will undergo necessary examinations and tests according to the protocol. Those who satisfy the selection criteria will be randomly assigned to either the NBT + acupotomy or NBT groups in a 1:1 ratio. Both groups will undergo 2 NBTs once every 2 weeks from 1 week after the screening test. The treatment group will receive additional acupotomy twice a week for 4 weeks. The primary endpoint is the Oswestry Disability Index, whereas the secondary endpoints are the Numeral Rating Scale, European Quality of Life 5-dimension, McGill pain Questionnaire, Roland-Morris Disability Questionnaire, safety assessment, and economic feasibility evaluation. The measurements will be made at 0, 2, 4, and 8 weeks.
ETHICS AND DISSEMINATION


This trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS20OISE0085). We intend to submit the results of the trial to a peer-reviewed journal and/or conferences.",2022,This trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS20OISE0085).,['50 patients with lumbosacral radiculopathy'],"['NBT\u200a+\u200aacupotomy or NBT', 'Nerve block therapy (NBT', 'nerve block therapy', 'deeply inserted acupotomy and NBT', 'additional acupotomy']","['prevalence of lumbosacral radiculopathy', 'Oswestry Disability Index', 'safety, effectiveness, and cost-effectiveness', 'Numeral Rating Scale, European Quality of Life 5-dimension, McGill pain Questionnaire, Roland-Morris Disability Questionnaire, safety assessment, and economic feasibility evaluation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154738', 'cui_str': 'Lumbosacral radiculopathy'}]","[{'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4505457', 'cui_str': 'Acupotomy'}, {'cui': 'C4554317', 'cui_str': 'Deeply'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0154738', 'cui_str': 'Lumbosacral radiculopathy'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1720186', 'cui_str': 'Numeral'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",50.0,0.0905063,This trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS20OISE0085).,"[{'ForeName': 'Sooil', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Catholic Kwandong University, International St. Mary's Hospital, Incheon, South Korea.""}, {'ForeName': 'Sukhee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Catholic Kwandong University, International St. Mary's Hospital, Incheon, South Korea.""}, {'ForeName': 'Young-Soo', 'Initials': 'YS', 'LastName': 'Lim', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Catholic Kwandong University, International St. Mary's Hospital, Incheon, South Korea.""}, {'ForeName': 'Tae-Yong', 'Initials': 'TY', 'LastName': 'Park', 'Affiliation': ""Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, South Korea.""}, {'ForeName': 'Kwang-Sun', 'Initials': 'KS', 'LastName': 'Do', 'Affiliation': ""Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, South Korea.""}, {'ForeName': 'Sang Hyun', 'Initials': 'SH', 'LastName': 'Byun', 'Affiliation': 'S-HEAL Pain and Korean Medicine Clinic, Seoul, South Korea.'}, {'ForeName': 'Sang-Hoon', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': 'Department of Applied Korean Medicine, Graduate School, Kyung Hee University, Seoul, South Korea.'}, {'ForeName': 'Jin-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ""Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, South Korea.""}]",Medicine,['10.1097/MD.0000000000028983']
3274,35244061,"Effects of Bojungikgi-tang on anorexic patients with atopic dermatitis: A protocol for a randomized, usual care-controlled, assessor-blinded, parallel, pilot clinical trial.","BACKGROUND


Anorexia and atopic dermatitis (AD) are highly prevalent diseases, and the herbal medicine Bojungikgi-tang (BJT) has been frequently used for the treatment of both anorexia and AD. However, no study has simultaneously evaluated the effects of BJT for both anorexia and AD.
METHODS


A prospective, randomized, usual care-controlled, assessor-blinded. parallel, pilot clinical trial has been designed to explore the feasibility, preliminary effectiveness, and safety of BJT for the treatment of anorexic patients with AD. Forty anorexic patients with AD will be randomly assigned (1:1) to BJT or the usual care group. The BJT group will be administered BJT granules twice a day for 8 weeks and followed up for 4 weeks whereas the usual care group will not receive BJT granules. All participants in both groups will be provided with over-the-counter topical corticosteroids as a relief drug. Data will be collected at baseline and at 4, 8, and 12 weeks after randomization. The primary outcome is the score on the anorexia visual analog scale at 8 weeks post-treatment. The secondary outcomes include body weight, body fat percentage, body fat mass, skeletal muscle mass, SCORing of Atopic Dermatitis index, Validated Investigator Global Assessment scale for Atopic Dermatitis, Dermatology Life Quality Index, EuroQoL 5 Dimension 5 Level, deficiency and excess pattern identification questionnaire, total immunoglobulin E, eosinophil count, and frequency and amount of use of topical corticosteroids. Adverse events and laboratory test results will be monitored to assess safety. Fecal samples to check for gut microbiome changes and blood samples to check immune and metabolic markers will be collected before and after taking BJT.
DISCUSSION


This is the first trial that explores the preliminary effectiveness and safety of BJT for the treatment of anorexic patients with AD. The results of this pilot study will provide the basic evidence for large-scale, confirmatory, multicenter, high-quality clinical trials.
TRIAL REGISTRATION


Clinical Research Information Service, KCT0006784 (registered on November 26, 2021).",2022,This is the first trial that explores the preliminary effectiveness and safety of BJT for the treatment of anorexic patients with AD.,"['Forty anorexic patients with AD', 'anorexic patients with atopic dermatitis', 'anorexic patients with AD']","['BJT or the usual care group', 'BJT', 'Bojungikgi-tang']","['body weight, body fat percentage, body fat mass, skeletal muscle mass, SCORing of Atopic Dermatitis index, Validated Investigator Global Assessment scale for Atopic Dermatitis, Dermatology Life Quality Index, EuroQoL 5 Dimension 5 Level, deficiency and excess pattern identification questionnaire, total immunoglobulin E, eosinophil count, and frequency and amount of use of topical corticosteroids', 'score on the anorexia visual analog scale']","[{'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0428539', 'cui_str': 'Total immunoglobulin measurement'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",40.0,0.138145,This is the first trial that explores the preliminary effectiveness and safety of BJT for the treatment of anorexic patients with AD.,"[{'ForeName': 'Boram', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Kyunghee-daero 26, Dongdaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo-Ju', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Yuseong-daero 1672, Yuseong-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Jung', 'Affiliation': 'Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Yuseong-daero 1672, Yuseong-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'O-Jin', 'Initials': 'OJ', 'LastName': 'Kwon', 'Affiliation': 'KM Science Research Division, Korea Institute of Oriental Medicine, Yuseong-daero 1672, Yuseong-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Mi Mi', 'Initials': 'MM', 'LastName': 'Ko', 'Affiliation': 'KM Science Research Division, Korea Institute of Oriental Medicine, Yuseong-daero 1672, Yuseong-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Hyun Ah', 'Initials': 'HA', 'LastName': 'Jeong', 'Affiliation': 'Department of Korean Medicine Ophthalmology & Otolaryngology & Dermatology, Daejeon Korean Medicine Hospital of Daejeon University, Daedeok-daero 176 beon-gil 75, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Jeeyoun', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': 'KM Science Research Division, Korea Institute of Oriental Medicine, Yuseong-daero 1672, Yuseong-gu, Daejeon, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000028965']
3275,35244059,Acupuncture in the emergency department for pain management: A BraveNet multi-center feasibility study.,"PURPOSE


Pain accounts for up to 78% of emergency department (ED) patient visits and opioids remain a primary method of treatment despite risks of addiction and adverse effects. While prior acupuncture studies are promising as an alternative opioid-sparing approach to pain reduction, successful conduct of a multi-center pilot study is needed to prepare for a future definitive randomized control trial (RCT).
METHODS


Acupuncture in the Emergency Department for Pain Management (ACUITY) is funded by the National Center for Complementary and Integrative Health. The objectives are to: conduct a multi-center feasibility RCT, examine feasibility of data collection, develop/deploy a manualized acupuncture intervention and assess feasibility/implementation (barrier/facilitators) in 3 EDs affiliated with the BraveNet Practice Based Research Network.Adults presenting to a recruiting ED with acute non-emergent pain (e.g., musculoskeletal, back, pelvic, noncardiac chest, abdominal, flank or head) of ≥4 on a 0-10-point Numeric Rating Scale will be eligible. ED participants (n = 165) will be equally randomized to Acupuncture or Usual Care.At pre-, post-, and discharge time-points, patients will self-assess pain and anxiety using the Numeric Rating Scale. Pain, anxiety, post-ED opioid use and adverse events will be assessed at 1 and 4 weeks. Opioid utilization in the ED and discharge prescriptions will be extracted from patients' electronic medical records.Acupuncture recipients will asked to participate in a brief qualitative interview about 3 weeks after their discharge. ED providers and staff will also be interviewed about their general perspectives/experiences related to acupuncture in the ED and implementation of acupuncture in ACUITY.
RESULTS


Recruitment began on 5/3/21. As of 12/7/21: 84 patients have enrolled, the responsive acupuncture intervention has been developed and deployed, and 26 qualitative interviews have been conducted.
CONCLUSION


Successful conduct of ACUITY will provide the necessary framework for conducting a future, multi-center, definitive RCT of acupuncture in the ED.
CLINICAL TRIALSGOV


NCT04880733 https://clinicaltrials.gov/ct2/show/NCT04880733.",2022,"Adults presenting to a recruiting ED with acute non-emergent pain (e.g., musculoskeletal, back, pelvic, noncardiac chest, abdominal, flank or head) of ≥4 on a 0-10-point Numeric Rating Scale will be eligible.","['ED participants (n\u200a=\u200a165', 'Acupuncture in the Emergency Department for Pain Management (ACUITY', 'Adults presenting to a recruiting ED with acute non-emergent pain (e.g., musculoskeletal, back, pelvic, noncardiac chest, abdominal, flank or head) of ≥4 on a 0-10-point Numeric Rating Scale will be eligible', '12/7/21: 84 patients have enrolled, the responsive', '3 EDs affiliated with the BraveNet Practice Based Research Network', 'emergency department for pain management']","['acupuncture intervention', 'Acupuncture', 'Acupuncture or Usual Care']","['discharge time-points, patients will self-assess pain and anxiety using the Numeric Rating Scale', 'Opioid utilization', 'Pain, anxiety, post-ED opioid use and adverse events']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0230171', 'cui_str': 'Structure of lateral region of abdomen'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",165.0,0.151228,"Adults presenting to a recruiting ED with acute non-emergent pain (e.g., musculoskeletal, back, pelvic, noncardiac chest, abdominal, flank or head) of ≥4 on a 0-10-point Numeric Rating Scale will be eligible.","[{'ForeName': 'Jeffery A', 'Initials': 'JA', 'LastName': 'Dusek', 'Affiliation': 'UH Connor Whole Health, University Hospitals, Cleveland, OH.'}, {'ForeName': 'Gene A', 'Initials': 'GA', 'LastName': 'Kallenberg', 'Affiliation': 'Department of Family Medicine, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Hughes', 'Affiliation': 'Department of Emergency Medicine, Case Western Reserve University School of Medicine, Cleveland OH.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Storrow', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Coyne', 'Affiliation': 'Department of Emergency Medicine and Department of Radiation Medicine and Applied Sciences University of California San Diego La Jolla, CA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Vago', 'Affiliation': 'Department of Physical Medicine and Rehabilitation and Department of Psychiatry, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Arya', 'Initials': 'A', 'LastName': 'Nielsen', 'Affiliation': 'Department of Family Medicine and Community Health Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Karasz', 'Affiliation': 'Department of Family Medicine and Social Medicine, Albert Einstein College of Medicine/Montefiore, New York, NY.'}, {'ForeName': 'Ryung S', 'Initials': 'RS', 'LastName': 'Kim', 'Affiliation': 'Department of Epidemiology and Population Health and Institute of Clinical and Translational Research, Albert Einstein College of Medicine/Montefiore, New York, NY.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Surdam', 'Affiliation': 'UH Connor Whole Health, University Hospitals, Cleveland, OH.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Segall', 'Affiliation': 'UH Connor Whole Health, University Hospitals, Cleveland, OH.'}, {'ForeName': 'M Diane', 'Initials': 'MD', 'LastName': 'McKee', 'Affiliation': 'Department of Family Medicine and Community Health, University of Massachusetts School of Medicine, Worcester, MA.'}]",Medicine,['10.1097/MD.0000000000028961']
3276,35244043,Efficacy and safety of Qinghua Zhixie Decoction against diarrhea-predominate irritable bowel syndrome: A protocol for a randomized controlled trial.,"BACKGROUND


Diarrhea-predominant irritable bowel syndrome (D-IBS) is the main subtypes of irritable bowel syndrome (IBS). In recent years, more than half of IBS patients have received complementary and alternative medicine. Traditional Chinese herbal formula is widely used in Asia, and clinical studies have also found that Chinese herbal formula could significantly improve abdominal pain and diarrhea. We plan to carry out a randomized, controlled, double blind, clinical studies to observe the clinical efficacy of Qinghua Zhixie decoction in the treatment of D-IBS.
METHODS


Four hundred sixty-four participants will be randomly assigned to the treatment group and control group. Patients in both groups would take medications and stimulations simultaneously. The outcomes of IBS symptom severity score, quality of life, psychological states, and recurrence rate will be recorded. Statistics will be analyzed with the SPSS 22.0.
CONCLUSIONS


The findings of the study will identify the safety and efficacy of Qinghua Zhixie decoction in the treatment of D-IBS.
TRIAL REGISTRATION OSF REGISTRATION NUMBER


DOI 10.17605/OSF.IO/C8MHW.",2022,"The findings of the study will identify the safety and efficacy of Qinghua Zhixie decoction in the treatment of D-IBS.
","['against diarrhea-predominate irritable bowel syndrome', 'Four hundred sixty-four participants']","['Qinghua Zhixie Decoction', 'Qinghua Zhixie decoction', 'Traditional Chinese herbal formula']","['IBS symptom severity score, quality of life, psychological states, and recurrence rate', 'abdominal pain and diarrhea', 'Efficacy and safety']","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",464.0,0.267097,"The findings of the study will identify the safety and efficacy of Qinghua Zhixie decoction in the treatment of D-IBS.
","[{'ForeName': 'Lijiang', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Anorectal Surgery, Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Changshu, Jiangsu, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Yuyan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Anorectal Surgery, Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Changshu, Jiangsu, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Gong', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Changshu, Jiangsu Province, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Anorectal Surgery, Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Changshu, Jiangsu, China.'}]",Medicine,['10.1097/MD.0000000000028895']
3277,35244040,Clinical observation of Long chiropractic treatment on patients with neurogenic cervical spondylosis: Study protocol for a randomized controlled trial.,"ABSTRACT


Neurogenic cervical spondylosis is the most common type of cervical spondylosis, accounting for approximately 60% percent of the incidence of cervical spondylosis. Cervical spine Long manipulation and sling exercise training (SET) have obtained good therapeutic results in clinical rehabilitation. The aim of this study was to evaluate the effect of Long manipulation combined with SET on neurogenic cervical spondylosis. In this assessor-blind, randomized controlled trial, 90 eligible patients will be randomized into a combination treatment group (Long manipulation combined with SET), a Long manipulation group and a conventional massage group. The visual analogue score, the Neck Disability Index score, and muscle fatigue in the bilateral upper oblique and Musculus sternocleidomastoideus, using mean power frequency and median frequency from the surface electromyography frequency domain index, will be assessed before and after the intervention at 0 and 4 weeks, respectively.Trial registration: Registered in the Chinese Clinical Trial Registration Center with the number ChiCTR2100054978. Registered December 30, 2021.",2022,"The visual analogue score, the Neck Disability Index score, and muscle fatigue in the bilateral upper oblique and Musculus sternocleidomastoideus, using mean power frequency and median frequency from the surface electromyography frequency domain index, will be assessed before and after the intervention at 0 and 4 weeks, respectively.","['90 eligible patients', 'patients with neurogenic cervical spondylosis']","['conventional massage group', 'Cervical spine Long manipulation and sling exercise training (SET', 'combination treatment group (Long manipulation combined with SET', 'Long manipulation combined with SET', 'chiropractic treatment']","['visual analogue score, the Neck Disability Index score, and muscle fatigue in the bilateral upper oblique and Musculus sternocleidomastoideus', 'neurogenic cervical spondylosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1384641', 'cui_str': 'Cervical spondylosis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C1384641', 'cui_str': 'Cervical spondylosis'}]",90.0,0.155129,"The visual analogue score, the Neck Disability Index score, and muscle fatigue in the bilateral upper oblique and Musculus sternocleidomastoideus, using mean power frequency and median frequency from the surface electromyography frequency domain index, will be assessed before and after the intervention at 0 and 4 weeks, respectively.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'School of Sport Medicine and Rehabilitation, Beijing Sport University, Beijing, China.'}, {'ForeName': 'Zhongping', 'Initials': 'Z', 'LastName': 'Gu', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Services and Management, Ningbo College of Health Science, Ningbo, China.'}, {'ForeName': 'Junwu', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Services and Management, Ningbo College of Health Science, Ningbo, China.'}, {'ForeName': 'Peizhen', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'School of Sport Medicine and Rehabilitation, Beijing Sport University, Beijing, China.'}, {'ForeName': 'Faming', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Services and Management, Ningbo College of Health Science, Ningbo, China.'}]",Medicine,['10.1097/MD.0000000000028861']
3278,35244456,Quantification of Cardiovascular Regulation Applying Heart Rate Variability Analyses for Different Warm and Moist Chest Compresses in Healthy Subjects.,"Background:  In integrative medicine, complementary healing methods, such as external applications (massages, rhythmic rubs, and compresses), are part of the practice and clinical application and have proven their therapeutic effect in various fields.  Objective:  Aim of this exploratory, controlled, single-blinded study was to investigate the effects of three different warming chest compresses on cardiovascular regulation by analyzing heart rate variability (HRV) in healthy subjects.  Methods:  Over a period of 4 weeks, three different warming chest compresses (a hot water compress, a ginger powder compress, and a mustard flour compress) in 30 healthy subjects were analyzed. For all subjects, 48-h long-term electrocardiograms were recorded, and afterward, epochs of 5 min length extracted and analyzed by different linear and nonlinear HRV indices.  Results:  A moist chest compress did not result in any significant short- and long-term stimulation of the autonomic regulation, except for a short-term significant decrease in heart rate (meanNN,  p  < 0.05). Warm and moist chest compresses with ginger flour led to significantly increased HRV (sdNN,  p  < 0.05; symbolic dynamics2,  p  < 0.05) and its complexity (renyi4 entropy,  p  < 0.05) and a significant decrease in heart rate (meanNN,  p  < 0.00036), and thus to a short-term relaxation effect. In contrast, warm and moist chest compresses with mustard flour led to significantly decreased HRV and their complexity (time-, frequency-, and nonlinear dynamics domain,  p  < 0.00036), which can be interpreted as a stress reaction of the autonomous nervous system.  Conclusions:  The application of chest compresses led to short-term relaxation effects (ginger) as well as short-term stress effects (mustard) but not to any significant longer-term effect on HRV in healthy subjects.",2022,"Warm and moist chest compresses with ginger flour led to significantly increased HRV (sdNN,  p  < 0.05; symbolic dynamics2,  p  < 0.05) and its complexity (renyi4 entropy,  p  < 0.05) and a significant decrease in heart rate (meanNN,  p  < 0.00036), and thus to a short-term relaxation effect.","['Healthy Subjects', 'healthy subjects', '30 healthy subjects']",[],"['HRV', 'heart rate variability (HRV', 'heart rate', 'HRV and their complexity (time-, frequency-, and nonlinear dynamics domain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0206166', 'cui_str': 'Non-linear Dynamics'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",30.0,0.0092958,"Warm and moist chest compresses with ginger flour led to significantly increased HRV (sdNN,  p  < 0.05; symbolic dynamics2,  p  < 0.05) and its complexity (renyi4 entropy,  p  < 0.05) and a significant decrease in heart rate (meanNN,  p  < 0.00036), and thus to a short-term relaxation effect.","[{'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schulz', 'Affiliation': 'Division of Oncology and Hematology, Department of Pediatrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Stritter', 'Affiliation': 'Division of Oncology and Hematology, Department of Pediatrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Marie Michelle', 'Initials': 'MM', 'LastName': 'Gross', 'Affiliation': 'Division of Oncology and Hematology, Department of Pediatrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Miltner', 'Affiliation': 'University Heart Center Freiburg, Bad Krozingen, Germany.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Rapp', 'Affiliation': 'Clinic for Anthroposophic Medicine, Gemeinschaftskrankenhaus Havelhöhe, Berlin, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Wilde', 'Affiliation': 'Clinic for Anthroposophic Medicine, Gemeinschaftskrankenhaus Havelhöhe, Berlin, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Eggert', 'Affiliation': 'Division of Oncology and Hematology, Department of Pediatrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Rico', 'Initials': 'R', 'LastName': 'Schroeder', 'Affiliation': 'UST Umweltsensortechnik GmbH, Geschwenda, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Voss', 'Affiliation': 'Division of Oncology and Hematology, Department of Pediatrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Seifert', 'Affiliation': 'Division of Oncology and Hematology, Department of Pediatrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}]",Journal of integrative and complementary medicine,['10.1089/jicm.2021.0252']
3279,35244381,Short-Term Results of Ivabradine versus Metoprolol: The Effects on Atrial Fibrillation in Patients Undergoing Off-Pump Coronary Artery Bypass Grafting.,"INTRODUCTION


Classic coronary artery bypass grafting (CABG) surgery involves diastolic cardiac arrest under cardiopulmonary bypass, while off-pump CABG (OPCABG) has become widespread in recent years.
METHODS


174 patients who underwent OPCABG were included in the study. Patients were divided into two groups. Group I (n=90) received ivabradine and Group M (n=84) received metoprolol before surgery until postoperative day 10. Intraoperative arrhythmias and hypotension were recorded. Postoperative atrial fibrillation (AF) and arrhythmia, mortality and morbidity rates were assessed based on the 30-day postoperative follow-up.
RESULTS


There were no significant differences in the intraoperative amount of inotropic support and red blood cell transfusion between groups (P=0.87 and P=0.31). However, the rates of intraoperative arrhythmias and hypotension were not significantly higher in Group M (P=0.317 and P=0.47). Ventricular tachycardia/ventricular fibrillation (VT/VF) was observed in 2 patients in both groups. Postoperative AF occurred in 7 patients (7.7%) in Group I and in 10 patients (11.9%) in Group M. Although there was a trend towards a higher prevalence of AF in Group M patients, this did not reach statistical significance. In addition, mortality and morbidity rates were comparable between groups.",2022,"However, the rates of intraoperative arrhythmias and hypotension were not significantly higher in Group M (P=0.317 and P=0.47).","['Patients Undergoing Off-Pump Coronary Artery Bypass Grafting', '174 patients who underwent OPCABG were included in the study']","['metoprolol', 'pump CABG (OPCABG', 'Classic coronary artery bypass grafting (CABG) surgery', 'Metoprolol', 'ivabradine', 'Ivabradine']","['intraoperative amount of inotropic support and red blood cell transfusion', 'Postoperative atrial fibrillation (AF) and arrhythmia, mortality and morbidity rates', 'Ventricular tachycardia/ventricular fibrillation (VT/VF', 'Postoperative AF', 'Intraoperative arrhythmias and hypotension', 'mortality and morbidity rates', 'rates of intraoperative arrhythmias and hypotension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0042514', 'cui_str': 'Ventricular tachycardia'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",174.0,0.0414616,"However, the rates of intraoperative arrhythmias and hypotension were not significantly higher in Group M (P=0.317 and P=0.47).","[{'ForeName': 'Esra Erturk', 'Initials': 'EE', 'LastName': 'Tekin', 'Affiliation': 'Department of Cardiovascular Surgery, Mersin City Training and Research Hospital, Mersin, Turkey.'}, {'ForeName': 'Mehmet Ali', 'Initials': 'MA', 'LastName': 'Yeşiltaş', 'Affiliation': 'Department of Cardiovascular Surgery, Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'İsmail', 'Initials': 'İ', 'LastName': 'Haberal', 'Affiliation': 'Department of Cardiovascular Surgery, Istanbul University-Cerrahpasa Institute of Cardiology, Istanbul, Turkey.'}]",Brazilian journal of cardiovascular surgery,['10.21470/1678-9741-2021-0201']
3280,35244373,Custodiol versus Blood Cardioplegia: Comparison of Myocardial Immunohistochemical Analysis and Clinical Outcomes.,"INTRODUCTION


Custodiol (histidine-tryptophan-ketoglutarate) and repetitive blood cardioplegia are the solutions for myocardial protection and cardiac arrest. In this study, we aimed to compare immunohistochemical analysis, clinical outcomes, and cardiac enzyme values of Custodiol and blood cardioplegia groups.
METHODS


This was a randomized prospective study consisting of 2 groups and 20 patients, 10 patients for each group, who underwent mitral and mitral/tricuspid valve surgery. Group 1 was formed for Custodiol cardioplegia and group 2 for blood cardioplegia. Perioperative and postoperative cardiac events were recorded, cardiac enzymes were analyzed with intervals, and myocardial samples were taken for immunohistochemical analysis. Recorded data were statistically evaluated.
RESULTS


There was no significant difference for the Custodiol and blood cardioplegia groups in perioperative and postoperative cardiac performance and adverse events. Cardiac enzyme analysis showed no significant difference between groups. However, two parameters (eNOS, Bcl-2) were in favor of the Custodiol group in immunohistochemical studies. Custodiol performed better in cellular oxidative stress resistance and cellular viability.
CONCLUSION


Clinical outcomes and cardiac enzyme analysis results were similar regarding myocardial protection. However, Custodiol performed better in the immunohistochemical analysis.",2022,There was no significant difference for the Custodiol and blood cardioplegia groups in perioperative and postoperative cardiac performance and adverse events.,"['2 groups and 20 patients, 10 patients for each group, who underwent mitral and mitral/tricuspid valve surgery']","['Custodiol (histidine-tryptophan-ketoglutarate) and repetitive blood cardioplegia', 'Custodiol cardioplegia and group 2 for blood cardioplegia', 'Custodiol versus Blood Cardioplegia']","['myocardial protection', 'Custodiol and blood cardioplegia groups in perioperative and postoperative cardiac performance and adverse events', 'cellular oxidative stress resistance and cellular viability', 'Perioperative and postoperative cardiac events']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040960', 'cui_str': 'Tricuspid valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0019602', 'cui_str': 'Histidine'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0572595,There was no significant difference for the Custodiol and blood cardioplegia groups in perioperative and postoperative cardiac performance and adverse events.,"[{'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Sen', 'Affiliation': 'Department of Cardiovascular Surgery, Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Unal', 'Initials': 'U', 'LastName': 'Aydin', 'Affiliation': 'Department of Cardiovascular Surgery, Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Kadirogullari', 'Affiliation': 'Department of Cardiovascular Surgery, Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Salih', 'Initials': 'S', 'LastName': 'Güler', 'Affiliation': 'Department of Cardiovascular Surgery, GATA, Ankara, Turkey.'}, {'ForeName': 'Süheyla', 'Initials': 'S', 'LastName': 'Gonca', 'Affiliation': 'Department of Histology and Embryology, Kocaeli University School of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'Seyhun', 'Initials': 'S', 'LastName': 'Solakoğlu', 'Affiliation': 'Department of Histology and Embryology, Istanbul University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Karaçalılar', 'Affiliation': 'Department of Cardiovascular Surgery, Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Barış', 'Initials': 'B', 'LastName': 'Timur', 'Affiliation': 'Department of Cardiovascular Surgery, Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Onan', 'Affiliation': 'Department of Cardiovascular Surgery, Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}]",Brazilian journal of cardiovascular surgery,['10.21470/1678-9741-2020-0662']
3281,35244365,The effectiveness of home-based balance and pulmonary rehabilitation program in individuals with chronic obstructive pulmonary disease: a randomized controlled trial.,"BACKGROUND


Balance impairment and increased fall risk have been demonstrated in individuals with chronic obstructive pulmonary disease (COPD). However, studies investigating the effects of balance training especially when combined with pulmonary rehabilitation (PR) program in home-based setting are scarce.
AIM


To examine whether adding balance training to home-based pulmonary rehabilitation improves balance, fall risk, and disease-related symptoms in individuals with COPD.
DESIGN


Randomized, controlled, assessor-blinded trial with parallel two-group design.
SETTING


Home-based setting.
POPULATION


Forty-eight individuals diagnosed with COPD.
METHODS


Participants with COPD were randomly allocated to either a home-based PR or home-based balance training combined with PR (PR-BT) group (24 per group). Both groups exercised three days per week for eight-week. Primary outcomes were fall risk index and functional balance as measured by the Physiological Profile Assessment (PPA) and Timed Up and Go (TUG), respectively. Secondary outcomes were the Activities-specific Balance Confidence (ABC), Modified Medical Research Council dyspnea (mMRC), Six-Minute Walk Test (6MWT), and COPD assessment test (CAT). All outcome measures were assessed at baseline, postintervention, and three-month follow-up.
RESULTS


All participants completed the trial, with no reported adverse events. At postintervention, the PR-BT group demonstrated significantly greater improvements in PPA fall risk score (PR-BT: 1.1±0.8, PR: 2.4±1.5), TUG (PR-BT: 10.7±1.3, PR: 14.4±4.4 sec) and these improvements remained at three-month follow-up (all p <0.01). The ABC, mMRC, and CAT scores were also significant better for the PR-BT than the PR group both after intervention and at three-month follow-up (all p <0.05).
CONCLUSIONS


Eight-week home-based balance and PR program is feasible and effective in improving balance and fall risk as well as dyspnea, and well-being in individuals with COPD.
CLINICAL REHABILITATION IMPACT


Home-based balance and PR program is a promising approach for COPD rehabilitation especially in patients who are at risk of falls.",2022,"The ABC, mMRC, and CAT scores were also significant better for the PR-BT than the PR group both after intervention and at three-month follow-up (all p <0.05).
","['Participants with COPD', 'Home-based setting', 'individuals with chronic obstructive pulmonary disease', 'Forty-eight individuals diagnosed with COPD', 'individuals with COPD', 'individuals with chronic obstructive pulmonary disease (COPD', 'patients who are at risk of falls']","['PR program', 'balance training to home-based pulmonary rehabilitation', 'home-based balance and pulmonary rehabilitation program', 'home-based PR or home-based balance training combined with PR (PR-BT', 'pulmonary rehabilitation (PR) program']","['Activities-specific Balance Confidence (ABC), Modified Medical Research Council dyspnea (mMRC), Six-Minute Walk Test (6MWT), and COPD assessment test (CAT', 'balance, fall risk, and disease-related symptoms', 'fall risk index and functional balance as measured by the Physiological Profile Assessment (PPA) and Timed Up and Go (TUG', 'ABC, mMRC, and CAT scores', 'adverse events', 'PPA fall risk score']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1319362', 'cui_str': 'Falls assessment'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",48.0,0.0531757,"The ABC, mMRC, and CAT scores were also significant better for the PR-BT than the PR group both after intervention and at three-month follow-up (all p <0.05).
","[{'ForeName': 'Busaba', 'Initials': 'B', 'LastName': 'Chuatrakoon', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sureeporn', 'Initials': 'S', 'LastName': 'Uthaikhup', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Shirley P', 'Initials': 'SP', 'LastName': 'Ngai', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Chalerm', 'Initials': 'C', 'LastName': 'Liwsrisakun', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Chaicharn', 'Initials': 'C', 'LastName': 'Pothirat', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Somporn', 'Initials': 'S', 'LastName': 'Sungkarat', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand - somporn.sungkarat@cmu.ac.th.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.22.07383-X']
3282,35244362,"Self-efficacy impact of the Mini-CEX among nursing students in North Sumatera, Indonesia.","BACKGROUND


Mini-CEX is a popular workplace exam that includes direct observation and a feedback conversation. This evaluation occurs in a workplace setting as part of the daily work. Self-efficacy is a mandatory soft skill for nursing students during an internship. Therefore, this study aims to identify the effect of Mini-CEX on self-efficacy among these students.
DESIGN AND METHODS


A quasi-experiment design was conducted with a control group. All the nursing student intents of the Sari Mutiara Indonesia University were considered as the study population. This population was then divided into one control and one intervention group of 24 and 25 students, respectively. Subsequently, data collection was carried out using general self-efficacy.
RESULTS


The results showed the self-efficacy was low in the control group (66.7%), and Mini-CEX was discovered to have a significant effect on self-efficacy among nursing students undergoing internships (p=0.000).  Conclusions: The Mini-CEX was concluded to effectively increase self-efficacy among nursing students and is suggested as a mandatory method for evaluating these students.",2021,"The results showed the self-efficacy was low in the control group (66.7%), and Mini-CEX was discovered to have a significant effect on self-efficacy among nursing students undergoing internships (p=0.000).  ","['nursing students in North Sumatera, Indonesia', 'nursing students during an internship']",['Mini-CEX'],"['self-efficacy', 'Self-efficacy']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0205805', 'cui_str': 'Sumatera'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0237690', 'cui_str': 'Internship'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0381361,"The results showed the self-efficacy was low in the control group (66.7%), and Mini-CEX was discovered to have a significant effect on self-efficacy among nursing students undergoing internships (p=0.000).  ","[{'ForeName': 'Siska Evi', 'Initials': 'SE', 'LastName': 'Martina', 'Affiliation': 'Department of Nursing, Faculty of Pharmacy and Health Sciences, Sari Mutiara Indonesia University, North Sumatera. siskaevi21@gmail.com.'}, {'ForeName': 'Ivan Elisabeth', 'Initials': 'IE', 'LastName': 'Purba', 'Affiliation': 'Department of Public Health, Faculty of Pharmacy and Health Sciences, Sari Mutiara Indonesia University, North Sumatera. poerba.ivanelis@gmail.com.'}, {'ForeName': 'Janno', 'Initials': 'J', 'LastName': 'Sinaga', 'Affiliation': 'Department of Nursing, Faculty of Pharmacy and Health Sciences, Sari Mutiara Indonesia University, North Sumatera. jnsmim@gmail.com.'}, {'ForeName': 'Eva Hotmaria', 'Initials': 'EH', 'LastName': 'Simanjuntak', 'Affiliation': 'Department of Midwifery, Faculty of Pharmacy and Health Sciences, Sari Mutiara Indonesia University, North Sumatera. evasimanjuntak92@gmail.com.'}]",Journal of public health research,['10.4081/jphr.2021.2743']
3283,35244360,Effectiveness health education and infant therapeutic group therapy on baby aged 0-6 months to prevent stunting risk factors: mother depression.,"BACKGROUND


Stunting is a global and national problem that can be detected at the age of 2. Therefore, before this age, promotion efforts must be conducted to prevent stunting risk factors in the future. This study aims to determine the effect of health education and infant's Therapeutic Group Therapy on stunting's risk factor: maternal postpartum depression in Indonesia.
DESIGN AND METHODS


This study employed a quasi-experimental design with a pre-test and post-test with a control group. This study employed a purposive sampling technique, with 96 respondents divided into two groups. Intervention group 1 consisted of 48 people who received health education, and group 2 consisted of 48 people who received health education and infant's Therapeutic Group Therapy. The data were collected using the Depression Inventory-II (DI II) questionnaire with a bivariate analysis of the Wilcoxon test and frequency distribution.
RESULTS


The results show that health education and infant's Therapeutic Group Therapy significantly influence the risky factors in stunting: maternal depression. It can be concluded that there were significant changes in maternal postpartum depression in intervention group 1 and intervention group 2, but in intervention group 2 who got Health Promotion and Therapeutic Group Therapy (TKT) for Infants there was a bigger and more significant decrease.
CONCLUSIONS


Nursing action, infants' Therapeutic Group Therapy, and health education are recommended to prevent risk factors for stunting: mother depression. The results of this study are expected to underlie the development of mental health promotion to prevent stunted against maternal depression and preventive programs. In addition, the research is expected to underly provision of curative and rehabilitative programs for stunted.",2021,The results show that health education and infant's Therapeutic Group Therapy significantly influence the risky factors in stunting: maternal depression.,"[""stunting's risk factor: maternal postpartum depression in Indonesia"", '96 respondents divided into two groups']","[""48 people who received health education, and group 2 consisted of 48 people who received health education and infant's Therapeutic Group Therapy"", 'Health Promotion and Therapeutic Group Therapy (TKT', ""health education and infant's Therapeutic Group Therapy""]","['Depression Inventory-II (DI II) questionnaire', 'risky factors in stunting: maternal depression', 'maternal postpartum depression']","[{'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]",,0.00913098,The results show that health education and infant's Therapeutic Group Therapy significantly influence the risky factors in stunting: maternal depression.,"[{'ForeName': 'Wita', 'Initials': 'W', 'LastName': 'Oktaviana', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java. wita.oktaviana1993@gmail.com.'}, {'ForeName': 'Budi Anna', 'Initials': 'BA', 'LastName': 'Keliat', 'Affiliation': 'Department of Mental Health Nursing, Faculty of Nursing, Universitas Indonesia, Depok, West Java. budianna_keliat@yahoo.com.'}, {'ForeName': 'Ice Yulia', 'Initials': 'IY', 'LastName': 'Wardani', 'Affiliation': 'Department of Mental Health Nursing, Faculty of Nursing, Universitas Indonesia, Depok, West Java. iceyulia1@yahoo.com.'}, {'ForeName': 'Adella', 'Initials': 'A', 'LastName': 'Pratiwi', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java. dellaprtw9@gmail.com.'}]",Journal of public health research,['10.4081/jphr.2021.2740']
3284,35244344,Sympathomimetic increases resting energy expenditure following bariatric surgery: A randomized controlled clinical trial.,"OBJECTIVE


The aim of this study was to test the hypothesis that ephedrine + caffeine (EC) reduces the fall in resting energy expenditure (REE) following bariatric surgery.
METHODS


This 32-week, randomized, double-blinded, placebo-controlled trial included 142 patients who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) surgery. Participants were randomized to either EC or placebo for 27 weeks, beginning 5 weeks post surgery. The primary end points were change in REE (measured), percentage of predicted REE ([measured REE/Harris-Benedict equation-predicted REE] × 100), and body composition. Secondary outcomes included change in percentage of weight. Adverse events (AEs) were recorded.
RESULTS


The reduction in REE was smaller in the EC versus the placebo group, but it was not significant. Percentage of predicted REE was increased in the EC versus the placebo group (difference, mean [SE]: 5.82 [2.29], p = 0.013). Percentage of weight (difference: -3.83 [1.39], p = 0.007) was reduced in the EC versus the placebo group. Percentage of predicted REE was increased and body weight decreased in the EC-treated participants who underwent SG compared with those who underwent SG and were treated with placebo (difference in percentage of predicted REE = 8.06 [2.83], p = 0.006; difference in weight percentage = -4.37 [1.92], p = 0.025). Percentage of fat-free mass was increased in the SG participants treated with EC versus placebo (difference: 1.31 [0.63], p = 0.042). The most common AEs were anxiety, dizziness, insomnia, and tremors. Most AEs were not different from placebo by Week 32.
CONCLUSIONS


EC enhances weight loss and reduces the fall in REE following bariatric surgery. Adrenergic symptoms mostly resolve over time.",2022,"Percentage of weight (difference: -3.83 [1.39], p = 0.007) was reduced in the EC versus the placebo group.","['142 patients who underwent', 'bariatric surgery']","['ephedrine + caffeine (EC', 'placebo', 'Sympathomimetic', 'Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) surgery', 'EC versus placebo', 'EC or placebo']","['anxiety, dizziness, insomnia, and tremors', 'change in percentage of weight', 'Percentage of predicted REE', 'weight loss', 'reduction in REE', 'change in REE (measured), percentage of predicted REE ([measured REE/Harris-Benedict equation-predicted REE', 'Percentage of weight', 'Adverse events (AEs', 'body weight', 'Percentage of fat-free mass', 'resting energy expenditure (REE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039052', 'cui_str': 'Sympathomimetic agent'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}]",142.0,0.584058,"Percentage of weight (difference: -3.83 [1.39], p = 0.007) was reduced in the EC versus the placebo group.","[{'ForeName': 'Candida J', 'Initials': 'CJ', 'LastName': 'Rebello', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Dachuan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Johnson', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Patterson', 'Affiliation': 'Oregon Weight Loss Surgery, LLC, Portland, Oregon, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Raum', 'Affiliation': 'Oregon Weight Loss Surgery, LLC, Portland, Oregon, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.23384']
3285,35244287,Ovarian Response to Follicle Stimulating Hormone in Women with Polycystic Ovary Syndrome is Diminished Compared to Ovulatory Controls.,"OBJECTIVE


The mechanisms underlying ovarian dysfunction in Polycystic Ovary Syndrome (PCOS) have not been definitively established. Our objective was to perform a detailed examination of ovarian responses to recombinant follicle stimulating hormone (rFSH) in women with PCOS and controls.
DESIGN


This prospective, cross-over, dose-response study included three rFSH stimulation periods. Each stimulation period involved three consecutive, daily, subcutaneous injections of rFSH administered at a single dose. Low, medium, and high rFSH doses were weight-adjusted, corresponding to 0.5, 1.1, and 2.2 IU/kg/d, respectively. Stimulation periods occurred in randomized order and were separated by eight-week washouts.
PATIENTS


Thirty participants (8 PCOS, 22 controls) were studied. PCOS was defined by oligomenorrhea and clinical or biochemical androgen excess, excluding other etiologies of ovulatory dysfunction.
MEASUREMENTS


Blood samples were obtained for hormone measurements before- and 24 hours after- each rFSH injection.
RESULTS


Participants with PCOS had significantly greater BMI, AFC, and circulating testosterone, AMH, and LH concentrations compared to controls participants. Baseline estradiol (E2) concentrations were similar in both groups. At the lowest dose of rFSH, PCOS participants did not demonstrate E2 increments, whereas a significant increase occurred in controls. rFSH-induced E2 production per follicle was significantly reduced in PCOS participants compared to controls at all rFSH doses. Increasing T and decreasing AMH concentrations were associated with augmented E2 production per follicle.
CONCLUSIONS


Women with PCOS exhibited diminished initial E2 responses to rFSH compared to controls. These findings suggest that the mechanism of anovulation in PCOS may involve altered ovarian response to gonadotropins. This article is protected by copyright. All rights reserved.",2022,rFSH-induced E2 production per follicle was significantly reduced in PCOS participants compared to controls at all rFSH doses.,"['women with PCOS and controls', 'Women with Polycystic Ovary Syndrome', 'Thirty participants (8 PCOS, 22 controls) were studied', 'Polycystic Ovary Syndrome (PCOS']","['Follicle Stimulating Hormone', 'recombinant follicle stimulating hormone (rFSH', 'rFSH']","['Baseline estradiol (E2) concentrations', 'initial E2 responses', 'rFSH-induced E2 production per follicle', 'AMH concentrations', 'Ovarian Response', 'BMI, AFC, and circulating testosterone, AMH, and LH concentrations']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}]",3.0,0.0709649,rFSH-induced E2 production per follicle was significantly reduced in PCOS participants compared to controls at all rFSH doses.,"[{'ForeName': 'Tracy Nh', 'Initials': 'TN', 'LastName': 'Harrison', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Diego 9500 Gilman Drive #0633, La Jolla, California.'}, {'ForeName': 'R Jeffrey', 'Initials': 'RJ', 'LastName': 'Chang', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Diego 9500 Gilman Drive #0633, La Jolla, California.'}]",Clinical endocrinology,['10.1111/cen.14708']
3286,35244717,Acute Effects of Kisspeptin Administration on Bone Metabolism in Healthy Men.,"CONTEXT


Osteoporosis results from disturbances in bone formation and resorption. Recent non-human data suggests that the reproductive hormone, kisspeptin, directly stimulates osteoblast differentiation in vitro and thus could have clinical therapeutic potential. However, the effects of kisspeptin on human bone metabolism are currently unknown.
OBJECTIVE


To assess the effects of kisspeptin on human bone metabolism in vitro and in vivo.
DESIGN


In vitro study: Mono- and co-cultures of human osteoblasts and osteoclasts treated with kisspeptin. Clinical study: Randomized, placebo-controlled, double-blind, two-way crossover clinical study in twenty-six men investigating the effects of acute kisspeptin administration (90 minutes) on human bone metabolism, with blood sampling every 30 minutes to +90 minutes.
PARTICIPANTS


In vitro study: Twelve male blood donors and eight patients undergoing hip replacement surgery. Clinical Study: Twenty-six healthy eugonadal men (age 26.8±5.8 years).
INTERVENTION


Kisspeptin (versus placebo).
MAIN OUTCOME MEASURES


Changes in bone parameters and turnover markers.
RESULTS


Incubation with kisspeptin in vitro increased alkaline phosphatase levels in human bone marrow mesenchymal stem cells by 41.1% (P=0.0022), and robustly inhibited osteoclastic resorptive activity by up to 53.4% (P<0.0001), in a dose-dependent manner. Kisspeptin administration to healthy men increased osteoblast activity, as evidenced by a 20.3% maximal increase in total osteocalcin (P=0.021) and 24.3% maximal increase in carboxylated osteocalcin levels (P=0.014).
CONCLUSIONS


Collectively, these data provide the first human evidence that kisspeptin promotes osteogenic differentiation of osteoblast progenitors and inhibits bone resorption in vitro. Furthermore, kisspeptin acutely increases the bone formation marker osteocalcin but not resorption markers in healthy men, independent of downstream sex-steroid levels. Kisspeptin could therefore have clinical therapeutic application in the treatment of osteoporosis.",2022,"Furthermore, kisspeptin acutely increases the bone formation marker osteocalcin but not resorption markers in healthy men, independent of downstream sex-steroid levels.","['twenty-six men', 'Clinical Study: Twenty-six healthy eugonadal men (age 26.8±5.8 years', 'healthy men', 'Healthy Men', 'In vitro study: Twelve male blood donors and eight patients undergoing hip replacement surgery']","['Kisspeptin', 'placebo', 'kisspeptin', 'Kisspeptin (versus placebo', 'acute kisspeptin administration (90 minutes) on human bone metabolism, with blood sampling every 30 minutes to +90 minutes', 'Kisspeptin Administration']","['osteoblast activity', 'bone formation marker osteocalcin', 'bone parameters and turnover markers', 'alkaline phosphatase levels', 'carboxylated osteocalcin levels', 'total osteocalcin', 'Bone Metabolism', 'osteoclastic resorptive activity']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392806', 'cui_str': 'Insertion of hip prosthesis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0540309', 'cui_str': 'KISS1 protein, human'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0277764', 'cui_str': 'Human bone for identification'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0585318', 'cui_str': 'Every thirty minutes'}]","[{'cui': 'C0029418', 'cui_str': 'Osteoblast'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0428332', 'cui_str': 'Alkaline phosphatase level - finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",26.0,0.104968,"Furthermore, kisspeptin acutely increases the bone formation marker osteocalcin but not resorption markers in healthy men, independent of downstream sex-steroid levels.","[{'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Comninos', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Morten S', 'Initials': 'MS', 'LastName': 'Hansen', 'Affiliation': 'KMEB Molecular Endocrinology Laboratory, Department of Endocrinology, Odense University Hospital, Denmark.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Courtney', 'Affiliation': 'Department of Clinical Biochemistry, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Sirazum', 'Initials': 'S', 'LastName': 'Choudhury', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Edouard G', 'Initials': 'EG', 'LastName': 'Mills', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Phylactou', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Busbridge', 'Affiliation': 'Department of Clinical Biochemistry, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Muaza', 'Initials': 'M', 'LastName': 'Khir', 'Affiliation': 'Department of Clinical Biochemistry, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Thilipan', 'Initials': 'T', 'LastName': 'Thaventhiran', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bech', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Tan', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbara', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Frost', 'Affiliation': 'KMEB Molecular Endocrinology Laboratory, Department of Endocrinology, Odense University Hospital, Denmark.'}, {'ForeName': 'Waljit S', 'Initials': 'WS', 'LastName': 'Dhillo', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Imperial College London, London, UK.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgac117']
3287,35244704,Effect of Combination Treatment With Varenicline and Nicotine Patch on Smoking Cessation Among Smokers Who Drink Heavily: A Randomized Clinical Trial.,"Importance


The concurrent use of both tobacco and alcohol causes substantial disease and early mortality, and smokers who drink heavily tend to be less successful in smoking cessation than smokers who do not. Although varenicline combined with nicotine replacement therapy for smoking cessation has been examined among smokers who do not drink heavily, this combination treatment has not yet been examined among smokers who drink heavily.
Objective


To determine whether combined treatment with varenicline tartrate and nicotine patch improves continuous abstinence from cigarette smoking among smokers who drink heavily.
Design, Setting, and Participants


This double-blind, placebo-controlled, superiority randomized clinical trial evaluated combined treatment with varenicline and nicotine patch compared with placebo and nicotine patch for smoking cessation (primary outcome) and drinking behavior (secondary outcome) among smokers who drink heavily. The clinical trial was conducted at 2 outpatient sites in Chicago, Illinois, with enrollment from March 26, 2018, to February 14, 2020. The 122 participants were recruited from the community via social media and public transit advertisements and equally randomized to the 2 treatment groups, which were stratified by sex and smoking behavior. Eligible participants smoked between 5 and 30 cigarettes per day and drank heavily (>14 drinks per week for men or >7 drinks per week for women and ≥1 heavy drinking day [defined as >5 drinks per occasion for men or >4 drinks per occasion for women] per month for the past year) and had a desire to quit smoking.
Interventions


Varenicline tartrate, 1.0 mg, twice daily or matching placebo pills twice daily for 12 weeks. Nicotine patch at manufacturer-recommended doses for 10 weeks and brief individual smoking cessation counseling the week before the quit date and on the quit date.
Main Outcomes and Measures


The primary outcome was self-reported continuous cigarette abstinence through weeks 9 to 12; abstinence was biochemically confirmed at the week 12 study visit. Secondary outcomes were the frequency of weekly drinking and weekly heavy drinking during the study period.
Results


Among 122 participants (mean [SD] age, 44.0 [12.4] years; 67 men [54.9%]), 61 were randomly assigned to receive combined treatment with varenicline and nicotine patch (varenicline group), and 61 were randomly assigned to receive placebo and nicotine patch (placebo group). A total of 54 participants (44.3%) self-identified as Black, 56 (45.9%) as White, and 12 (9.8%) as other races (including American Indian or Alaska Native, Asian, >1 race, and unspecified race). A total of 8 participants (6.6%) self-identified as Hispanic and 114 (93.4%) as non-Hispanic ethnicity. Study retention to 12 weeks was 89%. The intention-to-treat analyses showed higher smoking cessation rates during weeks 9 to 12 in the varenicline group vs the placebo group (27 participants [44.3%] vs 17 participants [27.9%]; odds ratio, 2.20; 95% CI, 1.01-4.80; P = .047) and lower likelihood of relapse throughout treatment in the varenicline group relative to the placebo group (hazard ratio, 0.62; 95% CI, 0.40-0.96; P = .03). Both treatments were well tolerated; however, compared with participants in the placebo group, those in the varenicline group experienced more adverse effects, with 5 participants in the varenicline group discontinuing medication due to adverse effects.
Conclusions and Relevance


In this study, combined treatment with varenicline and nicotine patch was more effective than placebo and nicotine patch for smoking cessation among smokers who drink heavily. The combination treatment had no effect on alcohol consumption, with both groups showing significant reductions. Combination treatment with varenicline and nicotine patch may be a viable option for smokers who drink heavily.
Trial Registration


ClinicalTrials.gov Identifier: NCT02859142.",2022,"The intention-to-treat analyses showed higher smoking cessation rates during weeks 9 to 12 in the varenicline group vs the placebo group (27 participants [44.3%] vs 17 participants [27.9%]; odds ratio, 2.20; 95% CI, 1.01-4.80; P = .047) and lower likelihood of relapse throughout treatment in the varenicline group relative to the placebo group (hazard ratio, 0.62; 95% CI, 0.40-0.96; P = .03).","['122 participants (mean [SD] age, 44.0 [12.4] years; 67 men [54.9', 'A total of 54 participants (44.3%) self-identified as Black, 56 (45.9%) as White, and 12 (9.8%) as other races (including American Indian or Alaska Native, Asian, >1 race, and unspecified race', '122 participants were recruited from the community via social media and public transit advertisements and equally randomized to the 2 treatment groups, which were stratified by sex and smoking behavior', 'smokers who drink heavily', '2 outpatient sites in Chicago, Illinois, with enrollment from March 26, 2018, to February 14, 2020', 'Smokers', 'A total of 8 participants (6.6%) self-identified as Hispanic and 114 (93.4%) as non-Hispanic ethnicity', 'Eligible participants smoked between 5 and 30 cigarettes per day and drank heavily (>14 drinks per week for men or >7 drinks per week for women and ≥1 heavy drinking day [defined as >5 drinks per occasion for men or >4 drinks per occasion for women] per month for the past year) and had a desire to quit smoking', 'Who Drink Heavily']","['varenicline tartrate and nicotine patch', 'placebo', 'varenicline', 'placebo and nicotine patch', 'Varenicline tartrate, 1.0 mg, twice daily or matching placebo pills', 'nicotine replacement therapy', 'varenicline and nicotine patch', 'Varenicline and Nicotine Patch', 'placebo and nicotine patch (placebo', 'Nicotine patch', 'varenicline and nicotine patch (varenicline group']","['continuous abstinence from cigarette smoking', 'tolerated', 'self-reported continuous cigarette abstinence through weeks 9 to 12; abstinence', 'smoking cessation rates', 'alcohol consumption', 'adverse effects', 'Smoking Cessation', 'likelihood of relapse', 'frequency of weekly drinking and weekly heavy drinking during the study period']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1515945', 'cui_str': 'American Indian or Alaska native'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C1711887', 'cui_str': 'Varenicline tartrate'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",122.0,0.392887,"The intention-to-treat analyses showed higher smoking cessation rates during weeks 9 to 12 in the varenicline group vs the placebo group (27 participants [44.3%] vs 17 participants [27.9%]; odds ratio, 2.20; 95% CI, 1.01-4.80; P = .047) and lower likelihood of relapse throughout treatment in the varenicline group relative to the placebo group (hazard ratio, 0.62; 95% CI, 0.40-0.96; P = .03).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Vena', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Grant', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Dingcai', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.0951']
3288,35244702,Effects of Testing and Disclosing Ancestry-Specific Genetic Risk for Kidney Failure on Patients and Health Care Professionals: A Randomized Clinical Trial.,"Importance


Risk variants in the apolipoprotein L1 (APOL1 [OMIM 603743]) gene on chromosome 22 are common in individuals of West African ancestry and confer increased risk of kidney failure for people with African ancestry and hypertension. Whether disclosing APOL1 genetic testing results to patients of African ancestry and their clinicians affects blood pressure, kidney disease screening, or patient behaviors is unknown.
Objective


To determine the effects of testing and disclosing APOL1 genetic results to patients of African ancestry with hypertension and their clinicians.
Design, Setting, and Participants


This pragmatic randomized clinical trial randomly assigned 2050 adults of African ancestry with hypertension and without existing chronic kidney disease in 2 US health care systems from November 1, 2014, through November 28, 2016; the final date of follow-up was January 16, 2018. Patients were randomly assigned to undergo immediate (intervention) or delayed (waiting list control group) APOL1 testing in a 7:1 ratio. Statistical analysis was performed from May 1, 2018, to July 31, 2020.
Interventions


Patients randomly assigned to the intervention group received APOL1 genetic testing results from trained staff; their clinicians received results through clinical decision support in electronic health records. Waiting list control patients received the results after their 12-month follow-up visit.
Main Outcomes and Measures


Coprimary outcomes were the change in 3-month systolic blood pressure and 12-month urine kidney disease screening comparing intervention patients with high-risk APOL1 genotypes and those with low-risk APOL1 genotypes. Secondary outcomes compared these outcomes between intervention group patients with high-risk APOL1 genotypes and controls. Exploratory analyses included psychobehavioral factors.
Results


Among 2050 randomly assigned patients (1360 women [66%]; mean [SD] age, 53 [10] years), the baseline mean (SD) systolic blood pressure was significantly higher in patients with high-risk APOL1 genotypes vs those with low-risk APOL1 genotypes and controls (137 [21] vs 134 [19] vs 133 [19] mm Hg; P = .003 for high-risk vs low-risk APOL1 genotypes; P = .001 for high-risk APOL1 genotypes vs controls). At 3 months, the mean (SD) change in systolic blood pressure was significantly greater in patients with high-risk APOL1 genotypes vs those with low-risk APOL1 genotypes (6 [18] vs 3 [18] mm Hg; P = .004) and controls (6 [18] vs 3 [19] mm Hg; P = .01). At 12 months, there was a 12% increase in urine kidney disease testing among patients with high-risk APOL1 genotypes (from 39 of 234 [17%] to 68 of 234 [29%]) vs a 6% increase among those with low-risk APOL1 genotypes (from 278 of 1561 [18%] to 377 of 1561 [24%]; P = .10) and a 7% increase among controls (from 33 of 255 [13%] to 50 of 255 [20%]; P = .01). In response to testing, patients with high-risk APOL1 genotypes reported more changes in lifestyle (a subjective measure that included better dietary and exercise habits; 129 of 218 [59%] vs 547 of 1468 [37%]; P < .001) and increased blood pressure medication use (21 of 218 [10%] vs 68 of 1468 [5%]; P = .005) vs those with low-risk APOL1 genotypes; 1631 of 1686 (97%) declared they would get tested again.
Conclusions and Relevance


In this randomized clinical trial, disclosing APOL1 genetic testing results to patients of African ancestry with hypertension and their clinicians was associated with a greater reduction in systolic blood pressure, increased kidney disease screening, and positive self-reported behavior changes in those with high-risk genotypes.
Trial Registration


ClinicalTrials.gov Identifier: NCT02234063.",2022,"At 12 months, there was a 12% increase in urine kidney disease testing among patients with high-risk APOL1 genotypes (from 39 of 234 [17%] to 68 of 234 [29%]) vs a 6% increase among those with low-risk APOL1 genotypes (from 278 of 1561 [18%] to 377 of 1561 [24%]; P = .10) and a 7% increase among controls (from 33 of 255 [13%] to 50 of 255 [20%]; P = .01).","['people with African ancestry and hypertension', '2050 adults of African ancestry with hypertension and without existing chronic kidney disease in 2 US health care systems from November 1, 2014, through November 28, 2016; the final date of follow-up was January 16, 2018', 'patients of African ancestry with hypertension and their clinicians', 'Kidney Failure on Patients and Health Care Professionals', 'patients with high-risk APOL1 genotypes vs those with low-risk APOL1 genotypes and controls (137 [21] vs 134 [19', '2050 randomly assigned patients (1360 women [66%]; mean [SD] age, 53 [10] years']","['undergo immediate (intervention) or delayed (waiting list control group', 'APOL1 genetic testing results from trained staff; their clinicians received results through clinical decision support in electronic health records', 'Testing and Disclosing Ancestry-Specific Genetic Risk']","['3-month systolic blood pressure and 12-month urine kidney disease screening', 'urine kidney disease testing', 'baseline mean (SD) systolic blood pressure', 'systolic blood pressure, increased kidney disease screening, and positive self-reported behavior changes', 'mean (SD) change in systolic blood pressure', 'blood pressure medication use']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1447574', 'cui_str': 'APOL1 protein, human'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1447574', 'cui_str': 'APOL1 protein, human'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",2050.0,0.128104,"At 12 months, there was a 12% increase in urine kidney disease testing among patients with high-risk APOL1 genotypes (from 39 of 234 [17%] to 68 of 234 [29%]) vs a 6% increase among those with low-risk APOL1 genotypes (from 278 of 1561 [18%] to 377 of 1561 [24%]; P = .10) and a 7% increase among controls (from 33 of 255 [13%] to 50 of 255 [20%]; P = .01).","[{'ForeName': 'Girish N', 'Initials': 'GN', 'LastName': 'Nadkarni', 'Affiliation': 'Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Kezhen', 'Initials': 'K', 'LastName': 'Fei', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Ramos', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Hauser', 'Affiliation': 'Institute for Family Health, New York, New York.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Bagiella', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Ellis', 'Affiliation': 'The Charles Bronfman Institute for Personalized Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Sanderson', 'Affiliation': 'The Charles Bronfman Institute for Personalized Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Scott', 'Affiliation': 'The Charles Bronfman Institute for Personalized Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Sabin', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Ebony', 'Initials': 'E', 'LastName': 'Madden', 'Affiliation': 'National Human Genome Research Institute, Bethesda, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Cooper', 'Affiliation': 'Department of Public Health Sciences, Loyola University Medical School, Maywood, Illinois.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pollak', 'Affiliation': 'Division of Nephrology, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Calman', 'Affiliation': 'Institute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Erwin P', 'Initials': 'EP', 'LastName': 'Bottinger', 'Affiliation': 'Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Horowitz', 'Affiliation': 'The Charles Bronfman Institute for Personalized Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2022.1048']
3289,35244504,The Cognitive Orientation to daily Occupational Performance (CO-OP) Approach is superior to ordinary treatment for achievement of goals and transfer effects in children with cerebral palsy and spina bifida - a randomized controlled trial.,"PURPOSE


Children with cerebral palsy (CP) or spina bifida (SB) often have executive dysfunction affecting activity performance. With the Cognitive Orientation to daily Occupational Performance (CO-OP) Approach, children find their own way to perform activities, using problem-solving strategies and meta-cognitive thinking. The present study aimed to investigate the effectiveness of the CO-OP Approach in children with CP or SB, compared with conventional rehabilitation, in achieving self-identified activity goals, and to explore any generalization and transfer effects.
METHOD


Randomized controlled trial, CO-OP versus treatment as usual, 38 children (7-16 years) participated. Each child identified four goals (to study generalization and transfer, one remained untrained). Primary outcomes: Canadian Occupational Performance Measure (COPM) and Performance Quality Rating Scale (PQRS). Secondary outcomes assessed executive functions and self-rated everyday-life competence.
RESULTS


Self-rated goal attainment (COPM) was significantly greater for both trained and untrained goals in the CO-OP group compared with the control group. The rating of observed performance (PQRS) was significantly higher for trained goals in the CO-OP group. The CO-OP group experienced fewer problems in everyday life after treatment. Executive functions did not differ significantly between groups.
CONCLUSION


CO-OP is more effective than ordinary treatment in achieving both trained and untrained goals.IMPLICATIONS FOR REHABILITATIONCO-OP enables children with CP (MACS levels I-III) or SB without intellectual disabilities to reach self-identified goals.CO-OP shows transfer effects to new activities and situations, which may enhance children's self-efficacy.CO-OP is an important complement to conventional rehabilitation services for children with CP and SB.",2022,"Executive functions did not differ significantly between groups.
","['Children with cerebral palsy (CP) or spina bifida (SB', 'children with CP (MACS levels I-III) or SB without intellectual disabilities', 'children with CP and SB', 'children with CP or SB', '38 children (7-16\u2009years) participated', 'children with cerebral palsy and spina bifida']","['CO-OP Approach', 'Cognitive Orientation to daily Occupational Performance (CO-OP) Approach', 'CO-OP']","['Executive functions', 'Canadian Occupational Performance Measure (COPM) and Performance Quality Rating Scale (PQRS', 'executive functions and self-rated everyday-life competence', 'rating of observed performance (PQRS', 'Self-rated goal attainment (COPM', 'everyday life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0037917', 'cui_str': 'Spina bifida aperta'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",38.0,0.0238212,"Executive functions did not differ significantly between groups.
","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Peny-Dahlstrand', 'Affiliation': 'Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Occupational Therapy Unit, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Caisa', 'Initials': 'C', 'LastName': 'Hofgren', 'Affiliation': 'Region Västra Götaland, Habilitation & Health, Gothenburg, Sweden.'}, {'ForeName': 'Barbro', 'Initials': 'B', 'LastName': 'Lindquist', 'Affiliation': 'Department of Habilitation, Halmstad County Hospital, Halmstad, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Bergqvist', 'Affiliation': 'Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Occupational Therapy Unit, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Himmelmann', 'Affiliation': ""Region Västra Götaland, Sahlgrenska University Hospital, Queen Silvia Children's Hospital, Regional Rehabilitation Centre, Gothenburg, Sweden.""}, {'ForeName': 'Arve', 'Initials': 'A', 'LastName': 'Opheim', 'Affiliation': 'Region Västra Götaland, Habilitation & Health, Gothenburg, Sweden.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Sjöwall', 'Affiliation': ""Department of Women's and Children's Health, Pediatric Neuropsychiatry Unit, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Brock', 'Affiliation': ""The Sachsska, Children's and Adolescents' Clinic, Assessment Team Nacka, Sweden.""}, {'ForeName': 'Ann-Marie', 'Initials': 'AM', 'LastName': 'Öhrvall', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society (NVS), Division of Occupational Therapy, Karolinska Institutet, Stockholm, Sweden.'}]",Disability and rehabilitation,['10.1080/09638288.2022.2043459']
3290,35244878,Mother-Newborn Care Unit (MNCU) Experience in India: A Paradigm Shift in Care of Small and Sick Newborns.,"While a Cochrane review (2016) showed that kangaroo mother care (KMC) initiated after clinical stabilization reduces mortality by 40%, evidence of the effect of initiating KMC immediately after birth without waiting for babies to become stable was unavailable until recently. This research gap was addressed by a multicountry, randomized, controlled trial co-ordinated by WHO. This trial was conducted in five hospitals in Ghana, India, Malawi, Nigeria, and Tanzania. Implementation of this trial led to development of the ""mother-newborn care unit (MNCU)."" Mother-newborn care unit or mother-newborn intensive care unit (M-NICU) is a facility where sick and small newborns are cared with their mothers 24 × 7 with all facilities of level II newborn care and provision for postnatal care to mothers. The mother is not a mere visitor, but she has her bed inside the special newborn care unit (SNCU)/newborn intensive care unit (NICU) and as a resident of MNCU, becomes an active caregiver and is involved in continuum of neonatal care. The study results show that intervention babies in MNCU had 25% less mortality at 28 d of life, 35% less incidence of hypothermia, and 18% less suspected sepsis as compared to control babies cared in conventional NICU. World Health Organization is in the process of reviewing the current recommendations on care of preterm or LBW newborns considering new evidence that has become available. However, it would require national policy change to permit mother and surrogate in SNCU/NICU 24 × 7, making the concept of zero-separation a reality.",2022,"The study results show that intervention babies in MNCU had 25% less mortality at 28 d of life, 35% less incidence of hypothermia, and 18% less suspected sepsis as compared to control babies cared in conventional NICU.","['five hospitals in Ghana, India, Malawi, Nigeria, and Tanzania', '24\u2009×\u20097 with all facilities of level II newborn care and provision for postnatal care to mothers', 'Care of Small and Sick Newborns', 'sick and small newborns are cared with their mothers', 'Mother-Newborn Care Unit (MNCU) Experience in India']","['mother-newborn care unit (MNCU', 'Mother-newborn care unit or mother-newborn intensive care unit (M-NICU', 'kangaroo mother care (KMC']","['incidence of hypothermia', 'mortality', 'suspected sepsis']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0441926', 'cui_str': 'Level II'}, {'cui': 'C0204792', 'cui_str': 'Routine care of newborn'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0204792', 'cui_str': 'Routine care of newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]",,0.0295676,"The study results show that intervention babies in MNCU had 25% less mortality at 28 d of life, 35% less incidence of hypothermia, and 18% less suspected sepsis as compared to control babies cared in conventional NICU.","[{'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Chellani', 'Affiliation': 'Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, 110029, India. chellaniharish@gmail.com.'}, {'ForeName': 'Sugandha', 'Initials': 'S', 'LastName': 'Arya', 'Affiliation': 'Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, 110029, India.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Mittal', 'Affiliation': 'Department of Obstetrics, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': 'Department of Maternal, Newborn & Child, and Adolescent Health, and Ageing, World Health Organization, Geneva, Switzerland.'}]",Indian journal of pediatrics,['10.1007/s12098-022-04145-9']
3291,35244757,Effectiveness of an Online Programme to Tackle Individual's Meat Intake through SElf-regulation (OPTIMISE): A randomised controlled trial.,"PURPOSE


A reduction in meat intake is recommended to meet health and environmental sustainability goals. This study aimed to evaluate the effectiveness of an online self-regulation intervention to reduce meat consumption.
METHODS


One hundred and fifty one adult meat eaters were randomised 1:1 to a multi-component self-regulation intervention or an information-only control. The study lasted 9 weeks (1-week self-monitoring; 4-week active intervention; and 4-week maintenance phase). The intervention included goal-setting, self-monitoring, action-planning, and health and environmental feedback. Meat intake was estimated through daily questionnaires in weeks 1, 5 and 9. The primary outcome was change in meat consumption from baseline to five weeks. Secondary outcomes included change from baseline to nine weeks and change in red and processed meat intake. We used linear regression models to assess the effectiveness of all the above outcomes.
RESULTS


Across the whole sample, meat intake was 226 g/day at baseline, 118 g/day at five weeks, and 114 g/day at nine weeks. At five weeks, the intervention led to a 40 g/day (95%CI - 11.6,- 67.5, P = 0.006) reduction in meat intake, including a 35 g/day (95%CI - 7.7, - 61.7, P = 0.012) reduction in red and processed meat, relative to control. There were no significant differences in meat reduction after the four-week maintenance phase (- 12 g/day intervention vs control, 95% CI 19.1, - 43.4, P = 0.443). Participants said the intervention was informative and eye-opening.
CONCLUSION


The intervention was popular among participants and helped achieve initial reductions in meat intake, but the longer-term reductions did not exceed control.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04961216, 14th July 2021, retrospectively registered.",2022,One hundred and fifty one adult meat eaters were randomised 1:1 to a multi-component self-regulation intervention or an information-only control.,['One hundred and fifty one adult meat eaters'],"['multi-component self-regulation intervention or an information-only control', 'online self-regulation intervention', ""Online Programme to Tackle Individual's Meat Intake through SElf-regulation (OPTIMISE""]","['change in meat consumption', 'meat reduction', 'meat intake', 'change from baseline to nine weeks and change in red and processed meat intake', 'Meat intake']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025017', 'cui_str': 'Meat'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0556201', 'cui_str': 'Meat intake'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0556201', 'cui_str': 'Meat intake'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0556213', 'cui_str': 'Processed meat intake'}]",151.0,0.25267,One hundred and fifty one adult meat eaters were randomised 1:1 to a multi-component self-regulation intervention or an information-only control.,"[{'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Frie', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. Cristina.stewart@phc.ox.ac.uk.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Piernas', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Cook', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}]",European journal of nutrition,['10.1007/s00394-022-02828-9']
3292,35245011,Evaluation of efficacy and safety of long-acting PEGylated recombinant human growth hormone (Jintrolong) for patients with growth hormone deficiency.,"OBJECTIVES


This study aimed to compare the efficacy, safety and metabolic effects of once-weekly pegylated human growth hormone (PEG-rhGH) with daily rhGH in patients with growth hormone deficiency (GHD).
DESIGN


48 patients enrolled in this 12-month single-center, open-label, prospective, randomized controlled trial is allocated to PEG-rhGH 0.12 mg/kg/w and 0.20 mg/kg/w treatment. Besides, the control group allocated 23 patients treated with daily rhGH 0.28 mg/kg/w matched with sex, age, and baseline IGF-1 levels. The primary endpoint included height velocity (HV) and IGF-1 increase at the end of treatment. Other parameters associated with growth, metabolism and safety were also monitored.
RESULTS


In terms of HV increase, the efficacy of PEG-rhGH dosed at 0.12 mg/kg/w and 0.20 mg/kg/w was comparable to that of daily rhGH dosed at 0.28 mg/kg/w after 3, 6 and 12 treatment (p>0.05). IGF-1 concentration and IGF-1 SDS were both elevated significantly at 3, 6 and 12 months (p=0.000) into normal range following PEG-rhGH treatment. BMI SDS elevated after PEG-rhGH treatment for 3, 6 and 12 months (p=0.000). HbA1c elevated after 3 and 12 months (p=0.009) and METS-IR elevated after 6 months (p=0.019) compared with baseline. The differences of other metabolic indexes (such as blood glucose, blood lipid, etc.) have no statistical significance (p>0.05). No severe adverse event was observed among the three groups.
CONCLUSIONS


The efficacy and safety were promising and comparable between once-weekly PEG-rhGH and daily rhGH injection within 12 months. The negative influence on glucose homeostasis needed attention and monitoring.",2022,"BMI SDS elevated after PEG-rhGH treatment for 3, 6 and 12 months (p=0.000).","['patients with growth hormone deficiency', '48 patients enrolled in this 12-month single-center, open-label', 'patients with growth hormone deficiency (GHD']","['pegylated human growth hormone (PEG-rhGH) with daily rhGH', 'PEG-rhGH 0.12\xa0mg/kg/w and 0.20', 'long-acting PEGylated recombinant human growth hormone (Jintrolong', 'daily rhGH']","['efficacy, safety and metabolic effects', 'severe adverse event', 'BMI SDS', 'height velocity (HV) and IGF-1 increase', 'SDS', 'IGF-1 concentration and IGF-1', 'efficacy and safety', 'METS-IR elevated', 'growth, metabolism and safety', 'metabolic indexes (such as blood glucose, blood lipid, etc']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C3254127', 'cui_str': 'polyethylene glycol-recombinant human growth hormone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",48.0,0.0472159,"BMI SDS elevated after PEG-rhGH treatment for 3, 6 and 12 months (p=0.000).","[{'ForeName': 'Hanze', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, Translation Medicine Centre, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Danning', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, Translation Medicine Centre, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Yi', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital of Jining Medical University, Jining, Shandong Province, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': 'Key Laboratory of Endocrinology of National Health Commission, Department of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yunyun', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Key Laboratory of Endocrinology of National Health Commission, Department of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, Translation Medicine Centre, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, Translation Medicine Centre, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, State Key Laboratory of Complex Severe and Rare Diseases Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, Translation Medicine Centre, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}]",Journal of pediatric endocrinology & metabolism : JPEM,['10.1515/jpem-2021-0735']
3293,34485815,Association of Adiponectin and Vitamin D With Tumor Infiltrating Lymphocytes and Survival in Stage III Colon Cancer.,"Background


Adipocyte-derived adiponectin may play a role in the host inflammatory response to cancer. We examined the association of plasma adiponectin with the density of tumor-infiltrating lymphocytes (TILs) in colon cancers and with vitamin D, clinicopathological features, and patient survival.
Methods


Plasma adiponectin and 25-hydroxyvitamin D [25(OH)D] were analyzed by radioimmunoassay in 600 patients with stage III colon cancer who received FOLFOX-based adjuvant chemotherapy (NCCTG N0147 [Alliance]). TIL densities were determined in histopathological sections. Associations with disease-free survival (DFS), time to recurrence, and overall survival were evaluated by multivariable Cox regression adjusting for potential confounders (ie, body mass index, race, TILs, and N stage). All statistical tests were 2-sided.
Results


We found a statistically significant reduction in adiponectin, but not 25(OH)D, levels in tumors with high vs low TIL densities (median   =   6845 vs 8984 ng/mL;  P  = .04). A statistically significant reduction in adiponectin was also observed in obese (body mass index >30 kg/m 2 ) vs nonobese patients (median   =   6608 vs 12 351 ng/mL;  P  < .001), in men vs women (median   =   8185 vs 11 567 ng/mL;  P  < .001), in Blacks vs Whites or Asians (median   =   6412 vs 8847 vs 7858 ng/mL;  P  < .03), and in those with fewer lymph node metastases (N1 vs N2: median   =   7768 vs 9253 ng/mL;  P  = .01). Insufficiency of 25(OH)D (<30 ng/mL) was detected in 291 (48.5%) patients. In multivariable analyses, neither adiponectin nor 25(OH)D were associated with a statistically significant difference in DFS, overall survival , or time to recurrence in models adjusted for potential confounders. We found a statistically significant association of TILs with prognosis, yet no such interaction was observed for the association of adiponectin with TILs for DFS.
Conclusions


Lower circulating adiponectin levels were associated with a statistically significant increase in TIL densities in colon cancers, indicating an enhanced antitumor immune response. In contrast to TILs, neither adiponectin nor 25(OH)D was independently prognostic.",2021,"In multivariable analyses, neither adiponectin nor 25(OH)D were associated with a statistically significant difference in DFS, overall survival , or time to recurrence in models adjusted for potential confounders.","[' \u2009 7768 vs 9253', '600 patients with stage III colon cancer who received FOLFOX-based adjuvant chemotherapy (NCCTG N0147 [Alliance', ' \u2009 6412 vs 8847 vs 7858', 'Stage III Colon Cancer', 'vs 11 567', 'obese']",['Adiponectin and Vitamin D'],"['Plasma adiponectin and 25-hydroxyvitamin D [25(OH)D', 'DFS, overall survival , or time to recurrence', 'circulating adiponectin levels', 'adiponectin', 'TIL densities', 'disease-free survival (DFS), time to recurrence, and overall survival']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278480', 'cui_str': 'Carcinoma of colon, stage III'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",600.0,0.19906,"In multivariable analyses, neither adiponectin nor 25(OH)D were associated with a statistically significant difference in DFS, overall survival , or time to recurrence in models adjusted for potential confounders.","[{'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Division of Oncology and Mayo Clinic Comprehensive Cancer Center, Rochester, MN, USA.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Smyrk', 'Affiliation': 'Division of Oncology and Mayo Clinic Comprehensive Cancer Center, Rochester, MN, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'West Virginia University Cancer Institute, Morgantown, WV, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Cohen', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Sharlene', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': 'British Columbia Cancer Agency, Vancouver Cancer Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Morton S', 'Initials': 'MS', 'LastName': 'Kahlenberg', 'Affiliation': 'Surgical Oncology Associates of South Texas, San Antonio, TX, USA.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': 'Lehigh Valley Hospital, Allentown, PA, USA.'}, {'ForeName': 'Anthony F', 'Initials': 'AF', 'LastName': 'Shield', 'Affiliation': 'Wayne State University, Karmanos Cancer Institute, Detroit, MI, USA.'}, {'ForeName': 'Balkrishna N', 'Initials': 'BN', 'LastName': 'Jahagirdar', 'Affiliation': 'Metro Minnesota Community Oncology Research Consortium, Saint Paul, MN, USA.'}, {'ForeName': 'Sawyer B', 'Initials': 'SB', 'LastName': 'Jacobson', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Foster', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Pollak', 'Affiliation': 'McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Alberts', 'Affiliation': 'Division of Oncology and Mayo Clinic Comprehensive Cancer Center, Rochester, MN, USA.'}]",JNCI cancer spectrum,['10.1093/jncics/pkab070']
3294,34817905,Liver stiffness and prediction of cardiac outcomes in patients with acute decompensated heart failure.,"BACKGROUND


In acute decompensated heart failure (ADHF), noninvasive markers that predict morbidity and mortality are limited. Liver stiffness measurement (LSM) increases with hepatic fibrosis; however, it may be falsely elevated in patients with ADHF in the absence of liver disease. We investigated whether elevated LSM predicts cardiac outcomes in ADHF.
METHODS


In a prospective study, we examined 52 ADHF patients without liver disease between 2016 and 2017. Patients underwent liver 2D shear wave elastography (SWE) and were followed for 12 months to assess the outcomes of left ventricular assist device (LVAD), heart transplant (HT) or death.
RESULTS


The median LSM was elevated in patients who received an LVAD or HT within 30-days compared to those who did not (median [IQR]: 55.6 [22.5 - 63.4] vs 13.8 [9.5 - 40.3] kPa, p = .049). Moreover, the risk of composite outcome was highest in the 3rd tertile (> 39.8 kPa compared to 1 st  and 2 nd  combined, HR 2.83, 95% CI 1.20- 6.67, p = .02). Each 1-kPa increase in LSM was associated with a 1%-increase in the incidence rate of readmissions (IRR 1.01, 95% CI 1.00-1.02, p = .01).
CONCLUSIONS


LSM may serve as a novel noninvasive tool to determine LVAD, HT, or death in patients with ADHF.",2022,"Each 1-kPa increase in LSM was associated with a 1%-increase in the incidence rate of readmissions (IRR 1.01, 95% CI 1.00-1.02, p = .01).
","['patients with ADHF', '52 ADHF patients without liver disease between 2016 and 2017', 'patients with acute decompensated heart failure']",['liver 2D shear wave elastography (SWE'],"['left ventricular assist device (LVAD), heart transplant (HT) or death', 'risk of composite outcome', 'incidence rate of readmissions', 'LSM', 'median LSM', 'Liver stiffness and prediction of cardiac outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",,0.163655,"Each 1-kPa increase in LSM was associated with a 1%-increase in the incidence rate of readmissions (IRR 1.01, 95% CI 1.00-1.02, p = .01).
","[{'ForeName': 'Nishah', 'Initials': 'N', 'LastName': 'Panchani', 'Affiliation': 'Tinsley Harrison Internal Medicine Residency Program, The University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schulz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Van Zyl', 'Affiliation': 'Baylor Scott & White Research Institute, Baylor University Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Felius', 'Affiliation': 'Baylor Scott & White Research Institute, Baylor University Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Baxter', 'Affiliation': 'Baylor Scott & White Research Institute, Baylor University Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Eun Taek', 'Initials': 'ET', 'LastName': 'Yoon', 'Affiliation': 'Texas A&M College of Medicine, College Station, Texas, USA.'}, {'ForeName': 'Harith', 'Initials': 'H', 'LastName': 'Baldawi', 'Affiliation': 'Texas A&M College of Medicine, College Station, Texas, USA.'}, {'ForeName': 'Amarinder', 'Initials': 'A', 'LastName': 'Bindra', 'Affiliation': 'Baylor Scott & White Research Institute, Baylor University Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Sumeet K', 'Initials': 'SK', 'LastName': 'Asrani', 'Affiliation': 'Baylor Scott & White Research Institute, Baylor University Medical Center, Dallas, Texas, USA.'}]",Clinical transplantation,['10.1111/ctr.14545']
3295,35075174,Investigation of actual exposure to facial sheet mask preceding its risk assessment.,"The present study aimed to reveal the amount per application of facial sheet masks and its influencing factors in Chinese population to form the base for an accurate exposure assessment. A total of 175 healthy subjects aged 18 years or older were recruited and divided into two subgroups: one group of 35 subjects were asked to apply same mask for 5, 10, 15, 20, 25, and 30 min respectively, and the other 140 subjects were instructed to apply one of four types of facial sheet masks presented in the market for 15 min. Furthermore, phenoxyethanol and methylparaben were measured to reflect actual exposure to chemicals. The sharp increase in the relative exposure to phenoxyethanol (CAS NO.122-99-6) and methylparaben at 25 min and longer suggests applying facial sheet masks for longer than 20 min may drive the exposure to hazardous chemicals to increase significantly. The 90th percentile of amount per application for plant-cellulose, bamboo charcoal fiber, bio-cellulose, and binchotan charcoal fiber-based masks was 5.753, 5.371, 5.017, and 4.821 g respectively. In addition, men and subjects with sebaceous skin demonstrated lower amount per application compared to women and subjects with dry skin, respectively. Finally, our data showed that the larger the contacting area between face and mask, the more amount per application. We concluded that the appropriate time of application should be less than 20 min. And mask fabrics, gender, sebum content, and contacting area could significantly impact the risk assessment of facial sheet masks. Our data for the first time provides insights into a realistic risk assessment of facial sheet masks in Chinese population.",2022,The sharp increase in the relative exposure to phenoxyethanol (CAS NO.122-99-6) and methylparaben at 25 min and longer suggests applying facial sheet masks for longer than 20 min may drive the exposure to hazardous chemicals to increase significantly.,"['Chinese population', '175 healthy subjects aged 18\xa0years or older were recruited and divided into two subgroups: one group of 35 subjects were asked to apply same mask for 5, 10, 15, 20, 25, and 30\xa0min respectively, and the other 140 subjects']",[],[],"[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C4319553', 'cui_str': '140'}]",[],[],175.0,0.03026,The sharp increase in the relative exposure to phenoxyethanol (CAS NO.122-99-6) and methylparaben at 25 min and longer suggests applying facial sheet masks for longer than 20 min may drive the exposure to hazardous chemicals to increase significantly.,"[{'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'NMPA Key Laboratory for Monitoring and Evaluation of Cosmetics, Shanghai Municipal Center for Disease Control and Prevention, 1380 Zhongshan Rd. W., Changning District, Shanghai, 200336, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'NMPA Key Laboratory for Monitoring and Evaluation of Cosmetics, Shanghai Municipal Center for Disease Control and Prevention, 1380 Zhongshan Rd. W., Changning District, Shanghai, 200336, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'NMPA Key Laboratory for Monitoring and Evaluation of Cosmetics, Shanghai Municipal Center for Disease Control and Prevention, 1380 Zhongshan Rd. W., Changning District, Shanghai, 200336, China.'}, {'ForeName': 'Huailong', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'Shanghai Jahwa United Co. Ltd., Shanghai, 200082, China.'}, {'ForeName': 'Wenguang', 'Initials': 'W', 'LastName': 'Cui', 'Affiliation': 'Division of Public Health Service and Safety Assessment, Shanghai Institute of Preventive Medicine, 1380 Zhongshan Rd. W., Changning District, Shanghai, 200336, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'She', 'Affiliation': 'NMPA Key Laboratory for Monitoring and Evaluation of Cosmetics, Shanghai Municipal Center for Disease Control and Prevention, 1380 Zhongshan Rd. W., Changning District, Shanghai, 200336, China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Division of Public Health Service and Safety Assessment, Shanghai Institute of Preventive Medicine, 1380 Zhongshan Rd. W., Changning District, Shanghai, 200336, China. lizhu@scdc.sh.cn.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Shanghai Jahwa United Co. Ltd., Shanghai, 200082, China.'}, {'ForeName': 'Dengfeng', 'Initials': 'D', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Jahwa United Co. Ltd., Shanghai, 200082, China.'}, {'ForeName': 'Zhitao', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Shanghai Jahwa United Co. Ltd., Shanghai, 200082, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': 'NMPA Key Laboratory for Monitoring and Evaluation of Cosmetics, Shanghai Municipal Center for Disease Control and Prevention, 1380 Zhongshan Rd. W., Changning District, Shanghai, 200336, China. sujin@scdc.sh.cn.'}]",Scientific reports,['10.1038/s41598-022-05351-3']
3296,33169185,Comparison of the efficacy and safety of microscopic and laparoscopic surgery for varicocele.,,2022,,['varicocele'],['microscopic and laparoscopic surgery'],['efficacy and safety'],"[{'cui': 'C0042341', 'cui_str': 'Varicocele'}]","[{'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0529957,,"[{'ForeName': 'Zixiang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Urology, The Affiliated Hospital of Xuzhou Medical University, No. 99 Huaihai West Road, Quanshan District, Xuzhou, 221000, Jiangsu, China.'}, {'ForeName': 'Simeng', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, 221000, Jiangsu, China.'}, {'ForeName': 'Raorao', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, The Affiliated Hospital of Xuzhou Medical University, No. 99 Huaihai West Road, Quanshan District, Xuzhou, 221000, Jiangsu, China.'}, {'ForeName': 'Junqi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, The Affiliated Hospital of Xuzhou Medical University, No. 99 Huaihai West Road, Quanshan District, Xuzhou, 221000, Jiangsu, China. wangxi19960118@163.com.'}]",World journal of urology,['10.1007/s00345-020-03516-1']
3297,33145667,Study on the effect of rapid rehabilitation nursing in postoperative rehabilitation of PCNL patients.,,2022,,['postoperative rehabilitation of PCNL patients'],['rapid rehabilitation nursing'],[],"[{'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0376427', 'cui_str': 'Nursing, Rehabilitation'}]",[],,0.021598,,"[{'ForeName': 'Zixiang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Urology, The Affiliated Hospital of Xuzhou Medical University, No. 99 Huaihai West Road, Quanshan District, Xuzhou, 221000, Jiangsu, China.'}, {'ForeName': 'Junqi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, The Affiliated Hospital of Xuzhou Medical University, No. 99 Huaihai West Road, Quanshan District, Xuzhou, 221000, Jiangsu, China. wangxi19960118@163.com.'}]",World journal of urology,['10.1007/s00345-020-03507-2']
3298,34195679,Differential modulation of polyunsaturated fatty acids in patients with myocardial infarction treated with ticagrelor or clopidogrel.,"Untargeted metabolomics is used to refine the development of biomarkers for the diagnosis of cardiovascular disease. Myocardial infarction (MI) has major individual and societal consequences for patients, who remain at high risk of secondary events, despite advances in pharmacological therapy. To monitor their differential response to treatment, we performed untargeted plasma metabolomics on 175 patients from the platelet inhibition and patient outcomes (PLATO) trial treated with ticagrelor and clopidogrel, two common P 2 Y 12  inhibitors. We identified a signature that discriminates patients, which involves polyunsaturated fatty acids (PUFAs) and particularly the omega-3 fatty acids docosahexaenoate and eicosapentaenoate. The known cardiovascular benefits of PUFAs could contribute to the efficacy of ticagrelor. Our work, beyond pointing out the high relevance of untargeted metabolomics in evaluating response to treatment, establishes PUFA metabolism as a pathway of clinical interest in the recovery path from MI.",2021,"We identified a signature that discriminates patients, which involves polyunsaturated fatty acids (PUFAs) and particularly the omega-3 fatty acids docosahexaenoate and eicosapentaenoate.","['patients with myocardial infarction treated with', '175 patients from the platelet inhibition and patient outcomes (PLATO) trial treated with']","['polyunsaturated fatty acids (PUFAs', 'ticagrelor or clopidogrel', 'polyunsaturated fatty acids', 'ticagrelor and clopidogrel, two common P 2 Y 12  inhibitors']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0608663', 'cui_str': 'P-2'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]",[],175.0,0.116886,"We identified a signature that discriminates patients, which involves polyunsaturated fatty acids (PUFAs) and particularly the omega-3 fatty acids docosahexaenoate and eicosapentaenoate.","[{'ForeName': 'Karla N', 'Initials': 'KN', 'LastName': 'Samman', 'Affiliation': 'Montreal Heart Institute, Montréal, QC, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Mehanna', 'Affiliation': 'Montreal Heart Institute, Montréal, QC, Canada.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Takla', 'Affiliation': 'Montreal Heart Institute, Montréal, QC, Canada.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Grenier', 'Affiliation': 'Montreal Heart Institute, Montréal, QC, Canada.'}, {'ForeName': 'Mark Y', 'Initials': 'MY', 'LastName': 'Chan', 'Affiliation': 'National University Heart Centre, Singapore, Singapore.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Megan Lee', 'Initials': 'ML', 'LastName': 'Neely', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Tracy Y', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'L Kristin', 'Initials': 'LK', 'LastName': 'Newby', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Becker', 'Affiliation': 'College of Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lordkipanidzé', 'Affiliation': 'Montreal Heart Institute, Montréal, QC, Canada.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Ruiz', 'Affiliation': 'Montreal Heart Institute, Montréal, QC, Canada.'}, {'ForeName': 'Julie G', 'Initials': 'JG', 'LastName': 'Hussin', 'Affiliation': 'Montreal Heart Institute, Montréal, QC, Canada.'}, {'ForeName': 'E Marc', 'Initials': 'EM', 'LastName': 'Jolicœur', 'Affiliation': 'Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.'}]",Cell reports. Medicine,['10.1016/j.xcrm.2021.100299']
3299,34923515,EFFECT OF RETINAL THICKNESS VARIABILITY ON VISUAL OUTCOMES AND FLUID PERSISTENCE IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Post Hoc Analysis of the HAWK and HARRIER Studies.,"PURPOSE


To determine the association between central subfield thickness (CST) variability and visual outcomes in eyes with neovascular age-related macular degeneration treated with anti-vascular endothelial growth factor therapies.
METHODS


In this post hoc, treatment-agnostic analysis, patients (N = 1,752) were grouped into quartiles of increasing CST variation. The association between CST variability and best-corrected visual acuity was measured from baseline, or from the end of the loading phase, until the end of the study using a multilevel modeling for repeated-measures model. The association between CST variability and the presence of retinal fluid was also assessed.
RESULTS


Increased CST variability was associated with worse best-corrected visual acuity outcomes at the end of study, with a least-square mean difference in best-corrected visual acuity of 8.9 Early Treatment Diabetic Retinopathy Study letters between the quartiles with the lowest and highest CST variability at the final visit. Increased variability was also associated with a higher mean fraction of visits with the presence of fluid.
CONCLUSION


More stable CST was associated with better visual outcomes at the end of treatment suggesting that CST variability may provide a more reliable prognostic marker of visual outcomes than the presence of fluid alone, with the potential to enhance the clinical care of neovascular age-related macular degeneration patients.",2022,"RESULTS


Increased CST variability was associated with worse best-corrected visual acuity outcomes at the end of study, with a least-square mean difference in best-corrected visual acuity of 8.9 Early Treatment Diabetic Retinopathy Study letters between the quartiles with the lowest and highest CST variability at the final visit.","['eyes with neovascular age-related macular degeneration treated with anti-vascular endothelial growth factor therapies', 'IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION']",[],"['visual acuity outcomes', 'CST variability and best-corrected visual acuity', 'CST variability', 'central subfield thickness (CST) variability and visual outcomes']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}]",[],"[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",1752.0,0.123304,"RESULTS


Increased CST variability was associated with worse best-corrected visual acuity outcomes at the end of study, with a least-square mean difference in best-corrected visual acuity of 8.9 Early Treatment Diabetic Retinopathy Study letters between the quartiles with the lowest and highest CST variability at the final visit.","[{'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, Arizona and USC Roski Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, California. Dr. Dugel is now with IVERIC bio, New York, New York.'}, {'ForeName': 'Chirag D', 'Initials': 'CD', 'LastName': 'Jhaveri', 'Affiliation': 'Retina Consultants of Austin and Austin Research Center for Retina, Austin, Texas.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""Institute of Clinical Science, The Queen's University of Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Retina Consultants of America, Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Rishi P', 'Initials': 'RP', 'LastName': 'Singh', 'Affiliation': 'Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Hamilton', 'Affiliation': 'National Institute for Health and Research Biomedical Centre, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Weissgerber', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland; and.'}, {'ForeName': 'Zufar', 'Initials': 'Z', 'LastName': 'Mulyukov', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland; and.'}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Holz', 'Affiliation': 'Department of Ophthalmology, University of Bonn, Bonn, Germany.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000003349']
3300,34545949,Factors Influencing Change in Serum Uric Acid After Administration of the Sodium-Glucose Cotransporter 2 Inhibitor Luseogliflozin in Patients With Type 2 Diabetes Mellitus.,"Although sodium-glucose cotransporter 2 (SGLT2) inhibitors lower serum uric acid, their long-term effect on uric acid metabolism is not well understood. We analyzed pooled data from studies wherein patients with type 2 diabetes mellitus received luseogliflozin, an SGLT2 inhibitor. Upon stratifying patients by baseline glycated hemoglobin (HbA 1c  ) or serum uric acid, lower HbA 1c  or higher serum uric acid level was associated with a greater reduction in serum uric acid after treatment. At week 12 of treatment, significant increases in urinary glucose/creatinine (Cr) ratio and urinary uric acid clearance/Cr clearance ratio (C UA  /C Cr  ratio) and a significant reduction in serum uric acid were observed. Comparison of the subgroups of patients with a reduction or an increase in serum uric acid showed that the increase subgroup had a higher estimated glomerular filtration rate (eGFR) at baseline, and the eGFR was significantly reduced, associated with a significant reduction in the C UA  /C Cr  ratio. Multiple regression analysis showed that the reduction in serum uric acid in the luseogliflozin group was strongly associated with baseline high serum uric acid, low HbA 1c  levels, and an increase in eGFR. Luseogliflozin was shown to reduce serum uric acid by enhancing urinary uric acid excretion in association with increased urinary glucose. Treatment with luseogliflozin resulted in increased serum uric acid in some patients, which may be due to reduced glomerular filtration of uric acid via the tubuloglomerular feedback. SGLT2 inhibitors reduced serum uric acid desirably in patients with type 2 diabetes mellitus with low HbA 1c  and high serum uric acid.",2022,"At week 12 of treatment, significant increases in urinary glucose/creatinine (Cr) ratio and urinary uric acid clearance/Cr clearance ratio (C UA  ","['patients with type 2 diabetes mellitus with low HbA 1c  and high serum uric acid', 'patients with type 2 diabetes mellitus', 'Patients With Type 2 Diabetes Mellitus']","['luseogliflozin', 'luseogliflozin, an SGLT2 inhibitor', 'SGLT2', 'Sodium-Glucose Cotransporter 2 Inhibitor Luseogliflozin', 'Luseogliflozin', 'sodium-glucose cotransporter 2 (SGLT2) inhibitors']","['eGFR', 'baseline glycated hemoglobin (HbA 1c  ) or serum uric acid', 'serum uric acid, low HbA 1c  levels', 'Serum Uric Acid', 'urinary glucose/creatinine (Cr) ratio and urinary uric acid clearance/Cr clearance ratio (C UA', 'serum uric acid', 'glomerular filtration rate (eGFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}]","[{'cui': 'C2933904', 'cui_str': '1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",,0.0504486,"At week 12 of treatment, significant increases in urinary glucose/creatinine (Cr) ratio and urinary uric acid clearance/Cr clearance ratio (C UA  ","[{'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Chino', 'Affiliation': 'Medical Information, Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Masanari', 'Initials': 'M', 'LastName': 'Kuwabara', 'Affiliation': 'Intensive Care Unit and Department of Cardiology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Hisatome', 'Affiliation': 'Division of Regenerative Medicine and Therapeutics, Department of Genomic Medicine and Regenerative Medicine, Faculty of Medicine, Tottori University, Yonago, Japan.'}]",Journal of clinical pharmacology,['10.1002/jcph.1970']
3301,34803132,NEW BIOMARKER QUANTIFYING THE EFFECT OF ANTI-VEGF THERAPY IN EYES WITH PROLIFERATIVE DIABETIC RETINOPATHY ON ULTRAWIDE FIELD FLUORESCEIN ANGIOGRAPHY: RECOVERY Study.,"PURPOSE


To quantify changes of the retinal vascular bed area (RVBA) in mm2 on stereographically projected ultrawide field fluorescein angiography images in eyes with proliferative diabetic retinopathy after antivascular endothelial growth factor injection.
METHODS


This is a prospective, observational study. The early-phase ultrawide field fluorescein angiography images (Optos 200Tx) of 40 eyes with proliferative diabetic retinopathy and significant nonperfusion obtained at baseline and after six months (NCT02863354) were stereographically projected by correcting peripheral distortion. The global retinal vasculature on ultrawide field fluorescein angiography was extracted for calculating RVBA by summing the real size (mm2) of all the pixels automatically.
RESULTS


For the entire cohort, the global RVBA for the entire retina decreased from 67.1 ± 15.5 to 43.6 ± 18.8 mm2 after anti-VEGF treatment at six months (P < 0.001). In the subgroup receiving monthly anti-VEGF injections, the global RVBA decreased from 68.7 ± 16.2 to 33.9 ± 13.3 mm2 (P < 0.001). In the subgroup receiving anti-VEGF every three months, the global RVBA decreased from 65.6 ± 15.1 to 50.8 ± 19.3 mm2 (P = 0.004).
CONCLUSION


RVBA seems to be a new biomarker to indicate efficiency of retinal vascular changes after anti-VEGF injection. Eyes with proliferative diabetic retinopathy and significant nonperfusion demonstrate reduced RVBA after anti-VEGF treatment.",2022,"In the subgroup receiving monthly anti-VEGF injections, the global RVBA decreased from 68.7 ± 16.2 to 33.9 ± 13.3 mm2 (P < 0.001).","['EYES WITH PROLIFERATIVE DIABETIC RETINOPATHY ON ULTRAWIDE FIELD', 'eyes with proliferative diabetic retinopathy after antivascular endothelial growth factor injection', '40 eyes with proliferative diabetic retinopathy']",['ANGIOGRAPHY'],"['RVBA', 'global RVBA']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0079280', 'cui_str': 'Endothelial Growth Factor'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0558274', 'cui_str': 'Bed area'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",40.0,0.0391312,"In the subgroup receiving monthly anti-VEGF injections, the global RVBA decreased from 68.7 ± 16.2 to 33.9 ± 13.3 mm2 (P < 0.001).","[{'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Beijing Tongren Eye Center, Beijing Tongren Hospital, Beijing Ophthalmology and Visual Sciences Key Laboratory, Capital Medical University, Beijing, China.'}, {'ForeName': 'Muneeswar Gupta', 'Initials': 'MG', 'LastName': 'Nittala', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Department of Ophthalmology, Medical Center Ophthalmology Associates, San Antonio, Texas.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'Department of Ophthalmology, Medical Center Ophthalmology Associates, San Antonio, Texas.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Uji', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Jano Van', 'Initials': 'JV', 'LastName': 'Hemert', 'Affiliation': 'Optos PLC, Dunfermline, United Kingdom.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Fleming', 'Affiliation': 'Optos PLC, Dunfermline, United Kingdom.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Robertson', 'Affiliation': 'Optos PLC, Dunfermline, United Kingdom.'}, {'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ip', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000003358']
3302,34868084,CCR5 Receptor Occupancy Analysis Reveals Increased Peripheral Blood CCR5+CD4+ T Cells Following Treatment With the Anti-CCR5 Antibody Leronlimab.,"CCR5 plays a central role in infectious disease, host defense, and cancer progression, thereby making it an ideal target for therapeutic development. Notably, CCR5 is the major HIV entry co-receptor, where its surface density correlates with HIV plasma viremia. The level of CCR5 receptor occupancy (RO) achieved by a CCR5-targeting therapeutic is therefore a critical predictor of its efficacy. However, current methods to measure CCR5 RO lack sensitivity, resulting in high background and overcalculation. Here, we report on two independent, flow cytometric methods of calculating CCR5 RO using the anti-CCR5 antibody, Leronlimab. We show that both methods led to comparable CCR5 RO values, with low background on untreated CCR5+CD4+ T cells and sensitive measurements of occupancy on both blood and tissue-resident CD4+ T cells that correlated longitudinally with plasma concentrations in Leronlimab-treated macaques. Using these assays, we found that Leronlimab stabilized cell surface CCR5, leading to an increase in the levels of circulating and tissue-resident CCR5+CD4+ T cells  in vivo  in Leronlimab-treated macaques. Weekly Leronlimab treatment in a chronically SIV-infected macaque led to increased CCR5+CD4+ T cells levels and fully suppressed plasma viremia, both concomitant with full CCR5 RO on peripheral blood CD4+ T cells, demonstrating that CCR5+CD4+ T cells were protected from viral replication by Leronlimab binding. Finally, we extended these results to Leronlimab-treated humans and found that weekly 700 mg Leronlimab led to complete CCR5 RO on peripheral blood CD4+ T cells and a statistically significant increase in CCR5+CD4+ T cells in peripheral blood. Collectively, these results establish two RO calculation methods for longitudinal monitoring of anti-CCR5 therapeutic antibody blockade efficacy in both macaques and humans, demonstrate that CCR5+CD4+ T cell levels temporarily increase with Leronlimab treatment, and facilitate future detailed investigations into the immunological impacts of CCR5 inhibition in multiple pathophysiological processes.",2021,"Weekly Leronlimab treatment in a chronically SIV-infected macaque led to increased CCR5+CD4+ T cells levels and fully suppressed plasma viremia, both concomitant with full CCR5 RO on peripheral blood CD4+ T cells, demonstrating that CCR5+CD4+ T cells were protected from viral replication by Leronlimab binding.",[],[],"['level of CCR5 receptor occupancy (RO', 'CCR5+CD4+ T cells', 'CCR5+CD4+ T cells levels', 'Peripheral Blood CCR5+CD4+ T Cells', 'CCR5 RO values', 'blood and tissue-resident CD4+ T cells', 'CCR5 RO lack sensitivity', 'peripheral blood CD4+ T cells']",[],[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0387687', 'cui_str': 'CC Chemokine Receptor 5'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0732772,"Weekly Leronlimab treatment in a chronically SIV-infected macaque led to increased CCR5+CD4+ T cells levels and fully suppressed plasma viremia, both concomitant with full CCR5 RO on peripheral blood CD4+ T cells, demonstrating that CCR5+CD4+ T cells were protected from viral replication by Leronlimab binding.","[{'ForeName': 'Xiao L', 'Initials': 'XL', 'LastName': 'Chang', 'Affiliation': 'Vaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Wu', 'Affiliation': 'Vaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Gabriela M', 'Initials': 'GM', 'LastName': 'Webb', 'Affiliation': 'Vaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Tiwary', 'Affiliation': 'Vaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': 'Vaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Reed', 'Affiliation': 'Vaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Vaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Waytashek', 'Affiliation': 'Vaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Boyle', 'Affiliation': 'Vaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Cleiton', 'Initials': 'C', 'LastName': 'Pessoa', 'Affiliation': 'Vaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Sylwester', 'Affiliation': 'Vaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Morrow', 'Affiliation': 'Vaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Belica', 'Affiliation': 'Vaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Oregon National Primate Research Center, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': 'CytoDyn Inc., Vancouver, WA, United States.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Pourhassan', 'Affiliation': 'CytoDyn Inc., Vancouver, WA, United States.'}, {'ForeName': 'Rachele M', 'Initials': 'RM', 'LastName': 'Bochart', 'Affiliation': 'Oregon National Primate Research Center, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Smedley', 'Affiliation': 'Oregon National Primate Research Center, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Recknor', 'Affiliation': 'CytoDyn Inc., Vancouver, WA, United States.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Hansen', 'Affiliation': 'Vaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Jonah B', 'Initials': 'JB', 'LastName': 'Sacha', 'Affiliation': 'Vaccine and Gene Therapy Institute, Oregon Health and Science University, Portland, OR, United States.'}]",Frontiers in immunology,['10.3389/fimmu.2021.794638']
3303,34987499,Lasting Immunological Imprint of Primary Epstein-Barr Virus Infection With Associations to Chronic Low-Grade Inflammation and Fatigue.,"Background


Epstein-Barr virus (EBV) causes infectious mononucleosis (IM) that can lead to chronic fatigue syndrome. The CEBA-project (Chronic fatigue following acute EBV infection in Adolescents) has followed 200 patients with IM and here we present an immunological profiling of adolescents with IM related to clinical characteristics.
Methods


Patients were sampled within 6 weeks of debut of symptoms and after 6 months. Peripheral blood mononuclear cells (PBMC) were cultured and stimulated  in vitro  (n=68), and supernatants analyzed for cytokine release. Plasma was analyzed for inflammatory markers (n=200). The Chalder Fatigue Questionnaire diagnosed patients with and without chronic fatigue at 6 months (CF+ and CF- group, respectively) (n=32 and n=91,  in vitro  and plasma cohorts, respectively.
Results


Broad activation of PBMC at baseline, with high levels of RANTES (Regulated on activation, normal T-cell expressed and secreted) in the CF+ group, and broad inflammatory response in plasma with high levels of T-cell markers was obeserved. At 6 months, there was an increased β-agonist response and RANTES was still elevated in cultures from the CF+ group. Plasma showed decrease of inflammatory markers except for CRP which was consistently elevated in the CF+ group.
Conclusion


Patients developing chronic fatigue after IM have signs of T-cell activation and low-grade chronic inflammation at baseline and after 6 months.
Clinical Trial Registration


https://clinicaltrials.gov/, identifier NCT02335437.",2021,"At 6 months, there was an increased β-agonist response and RANTES was still elevated in cultures from the CF+ group.","['Primary Epstein-Barr Virus Infection', 'Chalder Fatigue Questionnaire diagnosed patients with and without chronic fatigue at 6 months (CF+ and CF- group, respectively']",['\n\n\nEpstein-Barr virus (EBV'],"['Peripheral blood mononuclear cells (PBMC', 'chronic fatigue', 'signs of T-cell activation and low-grade chronic inflammation', 'inflammatory markers', 'β-agonist response']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0149678', 'cui_str': 'Epstein-Barr virus disease'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518656', 'cui_str': 'Chronic fatigue'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0518656', 'cui_str': 'Chronic fatigue'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]",200.0,0.346212,"At 6 months, there was an increased β-agonist response and RANTES was still elevated in cultures from the CF+ group.","[{'ForeName': 'Børre', 'Initials': 'B', 'LastName': 'Fevang', 'Affiliation': 'Section of Clinical Immunology and Infectious Diseases, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Vegard Bruun Bratholm', 'Initials': 'VBB', 'LastName': 'Wyller', 'Affiliation': 'Department of Pediatrics and Adolescent Health, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Tom Eirik', 'Initials': 'TE', 'LastName': 'Mollnes', 'Affiliation': 'Department of Immunology, Oslo University Hospital and University of Oslo, Oslo, Norway.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pedersen', 'Affiliation': 'Department of Pediatrics and Adolescent Health, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Tarjei Tørre', 'Initials': 'TT', 'LastName': 'Asprusten', 'Affiliation': 'Department of Pediatrics and Adolescent Health, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Michelsen', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Ueland', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Otterdal', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}]",Frontiers in immunology,['10.3389/fimmu.2021.715102']
3304,35245205,Outcomes in growth hormone-treated Noonan syndrome children: impact of PTPN11 mutation status.,"INTRODUCTION


Mutations in PTPN11 are associated with Noonan syndrome (NS). Although the effectiveness of growth hormone therapy (GHT) in treating short stature due to NS has been previously demonstrated, the effect of PTPN11 mutation status on the long-term outcomes of GHT remains to be elucidated.
METHODS


This analysis included pooled data from the observational American Norditropin Studies: Web-Enabled Research Program (NCT01009905) and the randomized, double-blind GHLIQUID-4020 clinical trial (NCT01927861). Pediatric patients with clinically diagnosed NS and confirmed PTPN11 mutation status were eligible for inclusion. The effectiveness analysis included patients who were GHT-naïve and pre-pubertal at GHT start. Growth outcomes and safety were assessed over 4 years of GHT (Norditropin®, Novo Nordisk A/S).
RESULTS


A total of 69 patients were included in the effectiveness analysis (71% PTPN11 positive). The proportion of females was 32.7% and 30.0% in PTPN11-positive and negative patients, respectively, and mean age at GHT start was 6.4 years in both groups. Using general population reference data, after 4 years of GHT, the mean (standard deviation [SD]) height SD score (HSDS) was -1.9 (1.1) and -1.7 (0.8) for PTPN11-positive and PTPN11-negative patients, respectively, with no statistical difference observed between groups. The mean (SD) change in HSDS at 4 years was +1.3 (0.8) in PTPN11-positive patients and +1.5 (0.7) in PTPN11-negative patients (no significant differences between groups). Safety findings were consistent with previous analyses.
CONCLUSIONS


GHT resulted in improved growth outcomes over 4 years in GHT-naïve, pre-pubertal NS patients, irrespective of PTPN11 mutation status.",2022,"CONCLUSIONS


GHT resulted in improved growth outcomes over 4 years in GHT-naïve, pre-pubertal NS patients, irrespective of PTPN11 mutation status.","['Pediatric patients with clinically diagnosed NS and confirmed', 'patients who were GHT-naïve and pre-pubertal at GHT start', '69 patients', 'treated Noonan syndrome children']","['PTPN11', 'growth hormone', 'growth hormone therapy (GHT', 'GHT']","['mean (standard deviation [SD]) height SD score (HSDS', 'growth outcomes', 'proportion of females', 'mean (SD) change in HSDS']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0028326', 'cui_str': ""Noonan's syndrome""}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1628325', 'cui_str': 'Pre-pubertal'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1566685', 'cui_str': 'PTPN11 protein, human'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",69.0,0.153875,"CONCLUSIONS


GHT resulted in improved growth outcomes over 4 years in GHT-naïve, pre-pubertal NS patients, irrespective of PTPN11 mutation status.","[{'ForeName': 'Alexander A L', 'Initials': 'AAL', 'LastName': 'Jorge', 'Affiliation': 'A Jorge, Unidale de Endocrinologia-Genetica, LIM/25, Disciplina de Endocrinologia da Faculdade de Medicina da Universidade de Sao Paulo (FMSUP), Sao Paulo, Brazil.'}, {'ForeName': 'Aven', 'Initials': 'A', 'LastName': 'Bang', 'Affiliation': 'A Bang, Alderley Edge, SK10 4TG, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Edouard', 'Affiliation': ""T Edouard, Endocrine, Bone Disease, and Genetics Unit, Children's Hospital, Toulouse University Hospital, RESTORE INSERM UMR1301, Toulouse, France.""}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Maghnie', 'Affiliation': 'M Maghnie, Department of Pediatrics, IRCCS Instituto Giannina Gaslini, Genova, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pietropoli', 'Affiliation': 'A Pietropoli, Novo Nordisk Healthcare AG, Global Medical Affairs Biopharm, Zurich, Switzerland.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Kelepouris', 'Affiliation': 'N Kelepouris, Novo Nordisk Inc., Clinical, Medical and Regulatory Biopharm-RED, Plainsboro, United States.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Romano', 'Affiliation': 'A Romano, Department of Pediatrics, New York Medical College, Valhalla, United States.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zenker', 'Affiliation': 'M Zenker, Institute of Human Genetics and Department of Pediatrics, University Hospital, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Horikawa', 'Affiliation': 'R Horikawa, Department of Endocrine and Metabolism, National Center for Child Health and Development, Tokyo, Japan.'}]",Endocrine connections,['10.1530/EC-21-0615']
3305,35245081,SuperSpeech: Multilingual Speech and Language Maintenance Intervention for Vietnamese-Australian Children and Families via Telepractice.,"PURPOSE


The aim of this pilot feasibility study was to evaluate the effectiveness of the group VietSpeech SuperSpeech program targeting speech skills and home language maintenance via telepractice.
METHOD


In Stage 1, using a case-control design, 30 Vietnamese-English-speaking children were assessed in English and Vietnamese, and parents completed questionnaires about speech and language competency and practices. During Stage 2, children were allocated to intervention ( n  = 14) or control ( n  = 16) conditions. COVID-19 restrictions resulted in changes including nonrandom allocation. Online group intervention targeting speech, home language maintenance, and multilingualism as a superpower was delivered 1 hr/week for 8 weeks. For Stage 3, assessments were undertaken approximately 10 weeks after the pre-intervention assessment.
RESULTS


Parents in the intervention group significantly increased encouragement of their children to speak Vietnamese. The intervention group significantly increased intelligibility in English. Growth of Vietnamese vocabulary was faster for the control group. There was a moderate effect of intervention for children's perception of being happy talking in Vietnamese and English. There was no significant mean change from pre- to post-intervention compared with the control group for measures of speech sound accuracy in Vietnamese or English, Vietnamese intelligibility, English vocabulary, or hours of Vietnamese spoken each week.
CONCLUSIONS


This study presents preliminary evidence that this 8-hr online group program targeting speech skills and home language maintenance had some impact on Vietnamese-Australian children's speech and home language maintenance. Further research involving a randomized trial is warranted.",2022,"There was no significant mean change from pre- to post-intervention compared with the control group for measures of speech sound accuracy in Vietnamese or English, Vietnamese intelligibility, English vocabulary, or hours of Vietnamese spoken each week.
","[""Vietnamese-Australian children's speech and home language maintenance"", 'Vietnamese-Australian Children and Families via Telepractice']",['SuperSpeech: Multilingual Speech and Language Maintenance Intervention'],"['nonrandom allocation', 'encouragement of their children to speak Vietnamese', 'intelligibility in English', 'speech sound accuracy in Vietnamese or English, Vietnamese intelligibility, English vocabulary, or hours of Vietnamese spoken each week']","[{'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0302830', 'cui_str': 'Multilingualism'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0589416', 'cui_str': 'Intelligibility'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037829', 'cui_str': 'Speech Sounds'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]",,0.0292957,"There was no significant mean change from pre- to post-intervention compared with the control group for measures of speech sound accuracy in Vietnamese or English, Vietnamese intelligibility, English vocabulary, or hours of Vietnamese spoken each week.
","[{'ForeName': 'Sharynne', 'Initials': 'S', 'LastName': 'McLeod', 'Affiliation': 'Charles Sturt University, Bathurst, New South Wales, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Verdon', 'Affiliation': 'Charles Sturt University, Bathurst, New South Wales, Australia.'}, {'ForeName': 'Van H', 'Initials': 'VH', 'LastName': 'Tran', 'Affiliation': 'Charles Sturt University, Bathurst, New South Wales, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Margetson', 'Affiliation': 'Charles Sturt University, Bathurst, New South Wales, Australia.'}, {'ForeName': 'Cen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Charles Sturt University, Bathurst, New South Wales, Australia.'}]","Language, speech, and hearing services in schools",['10.1044/2021_LSHSS-21-00146']
3306,35245446,"Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial.","Platinum-based chemotherapy is the standard first-line treatment for advanced esophageal squamous cell carcinoma (ESCC). In this phase 3 study (ClinicalTrial.gov: NCT03829969), 514 patients with treatment-naïve advanced ESCC were randomized (1:1) to receive toripalimab or placebo in combination with paclitaxel plus cisplatin (TP) every 3 weeks for up to 6 cycles, followed by toripalimab or placebo maintenance. At the prespecified final analysis of progression-free survival (PFS), a significant improvement in PFS is observed for the toripalimab arm over the placebo arm (hazard ratio [HR] = 0.58; 95% CI, 0.46-0.74; p < 0.0001). The prespecified interim analysis of overall survival (OS) also reveals a significant OS improvement for patients treated with toripalimab plus TP over placebo plus TP (HR = 0.58; 95% CI, 0.43-0.78; p = 0.0004). The incidences of grade ≥3 treatment-emergent adverse events are similar between the two arms. Toripalimab plus TP significantly improves PFS and OS in patients with treatment-naïve, advanced ESCC, with a manageable safety profile.",2022,"At the prespecified final analysis of progression-free survival (PFS), a significant improvement in PFS is observed for the toripalimab arm over the placebo arm (hazard ratio [HR] = 0.58; 95% CI, 0.46-0.74; p < 0.0001).","['advanced esophageal squamous cell carcinoma (ESCC', 'treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06', '514 patients with treatment-naïve advanced ESCC']","['Platinum-based chemotherapy', 'Toripalimab plus TP', 'Toripalimab plus chemotherapy', 'placebo', 'toripalimab or placebo in combination with paclitaxel plus cisplatin (TP', 'toripalimab or placebo maintenance']","['incidences of grade ≥3 treatment-emergent adverse events', 'PFS and OS', 'overall survival (OS', 'progression-free survival (PFS', 'PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242754', 'cui_str': 'Jupiter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",514.0,0.283635,"At the prespecified final analysis of progression-free survival (PFS), a significant improvement in PFS is observed for the toripalimab arm over the placebo arm (hazard ratio [HR] = 0.58; 95% CI, 0.46-0.74; p < 0.0001).","[{'ForeName': 'Zi-Xian', 'Initials': 'ZX', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou 510060, China; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou 510060, China.'}, {'ForeName': 'Chengxu', 'Initials': 'C', 'LastName': 'Cui', 'Affiliation': 'Cancer Hospital Chinese Academy of Medical Sciences, Beijing 100021, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology, Luoyang 471000, China.'}, {'ForeName': 'Yanqiao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin 150081, China.'}, {'ForeName': 'Mengxia', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Army Medical Center of PLA, Chongqing 400042, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing 210009, China.'}, {'ForeName': 'Shujun', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Henan Cancer Hospital & Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou 310022, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Linyi Cancer Hospital, Linyi 276000, China.'}, {'ForeName': 'Xizhi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""The Northern Jiangsu People's Hospital, Yangzhou 225001, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Beijing Cancer Hospital, Beijing 100142, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Jiangsu Province Hospital, Nanjing 210029, China.'}, {'ForeName': 'Cailian', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Zhongda Hospital Southeast University, Nanjing 210009, China.'}, {'ForeName': 'Tianyang', 'Initials': 'T', 'LastName': 'Dai', 'Affiliation': 'The Affiliated Hospital of Southwest Medical University, Luzhou 646000, China.'}, {'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Mao', 'Affiliation': 'Shanghai Chest Hospital, Shanghai 200030, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Guangxi Medical University Affiliated Tumor Hospital, Nanning 530000, China.'}, {'ForeName': 'Zengqing', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Fujian Cancer Hospital, Fuzhou 350000, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Shandong Cancer Hospital, Jinan 250117, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou 310000, China.'}, {'ForeName': 'Shundong', 'Initials': 'S', 'LastName': 'Cang', 'Affiliation': ""Henan Provincial People's Hospital, Zhengzhou 450000, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'The Affiliated Cancer Hospital of Shantou University Medical College, Shantou 515000, China.'}, {'ForeName': 'Junye', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Affiliated Hospital of Jining Medical University, Jining 272000, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': 'Jiangmen Central Hospital, Jiangmen 529000, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'The Second Hospital of Anhui Medical University, Hefei 230000, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'The Fourth Hospital of Hebei Medical University, Shijiazhuang 050000, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'The First Affiliated Hospital of Xiamen University, Xiamen 361000, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ren', 'Affiliation': 'Nanjing Drum Tower Hospital, Nanjing 530000, China.'}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Anyang Cancer Hospital, Anyang 455000, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Hunan Cancer Hospital, Changsha 410000, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'West China Hospital of Sichuan University, Chengdu 610000, China.'}, {'ForeName': 'Zhanhui', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'The First Affiliated Hospital of Xinxiang Medical University, Weihui 453100, China.'}, {'ForeName': 'Meili', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Jinan Central Hospital, Jinan 250000, China.'}, {'ForeName': 'Conghua', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Zhongnan Hospital of Wuhan University, Wuhan 430000, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Henan Cancer Hospital & Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450000, China.'}, {'ForeName': 'Qifeng', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Sichuan Cancer Hospital, Chengdu 610000, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Xijing Hospital, Xi'an 710000, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Shanghai General Hospital, Shanghai 200000, China.'}, {'ForeName': 'Canhong', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Nantong Tumor Hospital, Nantong 226000, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Jiang', 'Affiliation': 'Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430000, China.'}, {'ForeName': 'Kunyu', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430000, China.'}, {'ForeName': 'Daojun', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Yichang Central People's Hospital, Yichang 443000, China.""}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The First Hospital of China Medical University, Shenyang 110000, China.'}, {'ForeName': 'Zhitu', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'The First Affiliated Hospital of Jinzhou Medical University, Jinzhou 121000, China.'}, {'ForeName': 'Rixin', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': ""Liuzhou People's Hospital, Liuzhou 545000, China.""}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': 'China-Japan Friendship Hospital, Beijing 100000, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Bethune Hospital of Jilin University, Changchun 130000, China.'}, {'ForeName': 'Wangjun', 'Initials': 'W', 'LastName': 'Liao', 'Affiliation': 'Nanfang Hospital Southern Medical University, Guangzhou 510000, China.'}, {'ForeName': 'Hong-Xu', 'Initials': 'HX', 'LastName': 'Liu', 'Affiliation': 'Liaoning Cancer Hospital & Institute, Shenyang 110000, China.'}, {'ForeName': 'Daiyuan', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'The Affiliated Hospital of North Sichuan Medical College, Nanchong 637000, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'The First Affiliated Hospital of Guangxi Medical University, Nanning 530000, China.'}, {'ForeName': 'Yanru', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': ""Xinxiang First People's Hospital, Xinxiang 453000, China.""}, {'ForeName': 'Qichun', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou 310000, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'The Second Affiliated Hospital of Shantou University Medical College, Shantou 515000, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Shijiazhuang People's Hospital, Shijiazhuang 050000, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Affiliated Hospital of Guangdong Medical University, Zhanjiang 524000, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""The Second People's Hospital of Yibin, Yibin 644000, China.""}, {'ForeName': 'Guanghai', 'Initials': 'G', 'LastName': 'Dai', 'Affiliation': 'Chinese PLA General Hospital, Beijing 100000, China.'}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510000, China.'}, {'ForeName': 'Junhe', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Nanchang 330000, China.'}, {'ForeName': 'Guanghui', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'The Second Affiliated Hospital of Army Medical University, Chongqing 400037, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Xuzhou Central Hospital, Xuzhou 221000, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Jiangxi Cancer Hospital, Nanchang 330000, China.'}, {'ForeName': 'Xianglin', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Tongji Hospital Affiliated to Tongji Medical College, Wuhan 430000, China.'}, {'ForeName': 'Junping', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Shanxi Bethune Hospital, Taiyuan 030000, China.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': ""The 900th Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army, Fuzhou 350000, China.""}, {'ForeName': 'Yifu', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Anhui Provincial Cancer Hospital, Hefei 230000, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Ju', 'Affiliation': 'Qingdao Central Hospital, Qingdao 266000, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'HanDan Central Hospital, Handan 056000, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Tang', 'Affiliation': 'Tianjin Medical University Cancer Institute & Hospital, Tianjin 300000, China.'}, {'ForeName': 'Tiejun', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'The Second Hospital of Jilin University, Changchun 130000, China.'}, {'ForeName': 'Weibo', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Shandong Provincial Hospital, Jinan 250000, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'HuBei Cancer Hospital, Wuhan 430000, China.'}, {'ForeName': 'Xianming', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Shanghai Junshi Biosciences, Shanghai 200126, China.'}, {'ForeName': 'Xiongwen', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Shanghai Junshi Biosciences, Shanghai 200126, China; TopAlliance Biosciences, Rockville, MD 20850, USA.'}, {'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'May', 'Affiliation': 'TopAlliance Biosciences, Rockville, MD 20850, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'Shanghai Junshi Biosciences, Shanghai 200126, China; TopAlliance Biosciences, Rockville, MD 20850, USA.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Shanghai Junshi Biosciences, Shanghai 200126, China; TopAlliance Biosciences, Rockville, MD 20850, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Keegan', 'Affiliation': 'TopAlliance Biosciences, Rockville, MD 20850, USA.'}, {'ForeName': 'Rui-Hua', 'Initials': 'RH', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou 510060, China; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou 510060, China. Electronic address: xurh@sysucc.org.cn.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou 510060, China; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou 510060, China. Electronic address: wangfeng@sysucc.org.cn.'}]",Cancer cell,['10.1016/j.ccell.2022.02.007']
3307,35245416,Five-Year Structural Changes in Patients with Meniscal Tear and Osteoarthritis: Data from an RCT of Arthroscopic Partial Meniscectomy vs. Physical Therapy.,"OBJECTIVE


Data from long-term follow-up of several randomized controlled trials (RCTs) of arthroscopic partial meniscectomy (APM) vs. non-operative therapy or sham have suggested that APM may be associated with increased risk of worsening in radiographic features of osteoarthritis (OA). Our objective was to estimate the risk of MRI-based OA structural changes using baseline, 18-month, and 60-month MRI data from an RCT of APM vs. physical therapy in participants with meniscal tear and OA.
METHODS


We used data from the MeTeOR (Meniscal Tear in Osteoarthritis Research) Trial. MRIs were read using the MRI OA Knee Score (MOAKS). We used linear mixed effects models to examine the association between treatment group and continuous MOAKS summary scores, and Poisson regression to assess categorical change in joint structure. Analyses assessed change from baseline to 18 months and 18-to-60 months. We performed both intention-to-treat and as-treated analyses.
RESULTS


The analytic sample included 302 participants. For both treatment groups, more change was seen over the earlier (baseline - 18 months) interval than the later interval. APM was associated with increased risk of any worsening in cartilage surface area damage score (relative risk 1.35, 95% CI 1.14-1.61), osteophytes, and effusion-synovitis over the earlier time period. Only change in osteophytes was significantly different between treatment groups in the later time period.
CONCLUSION


These findings suggest the association between APM and MRI-based changes is most apparent in the 18 months after surgery. The reason for the attenuation of this association over longer follow-up merits further investigation.",2022,"APM was associated with increased risk of any worsening in cartilage surface area damage score (relative risk 1.35, 95% CI 1.14-1.61), osteophytes, and effusion-synovitis over the earlier time period.","['Patients with Meniscal Tear and Osteoarthritis', 'participants with meniscal tear and OA', '302 participants']",['arthroscopic partial meniscectomy (APM) vs. non-operative therapy'],"['risk of any worsening in cartilage surface area damage score', 'change in osteophytes', 'MRI OA Knee Score (MOAKS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238218', 'cui_str': 'Tear of meniscus of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015302', 'cui_str': 'External hyperostosis'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]",302.0,0.247414,"APM was associated with increased risk of any worsening in cartilage surface area damage score (relative risk 1.35, 95% CI 1.14-1.61), osteophytes, and effusion-synovitis over the earlier time period.","[{'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Collins', 'Affiliation': ""Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Swastina', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': ""Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Losina', 'Affiliation': ""Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Marx', 'Affiliation': 'Department of Orthopaedic Surgery, Weill Cornell Medicine, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Quantitative Imaging Center, Department of Radiology, Boston University School of Medicine Boston, MA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Jarraya', 'Affiliation': 'Quantitative Imaging Center, Department of Radiology, Boston University School of Medicine Boston, MA.'}, {'ForeName': 'Morgan H', 'Initials': 'MH', 'LastName': 'Jones', 'Affiliation': ""Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Levy', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Mandl', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Emma E', 'Initials': 'EE', 'LastName': 'Williams', 'Affiliation': ""Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Rick W', 'Initials': 'RW', 'LastName': 'Wright', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Kurt P', 'Initials': 'KP', 'LastName': 'Spindler', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Katz', 'Affiliation': ""Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.42105']
3308,35245284,Evaluation of insecticide treated window curtains and water container covers for dengue vector control in a large-scale cluster-randomized trial in Venezuela.,"BACKGROUND


Following earlier trials indicating that their potential in dengue vector control was constrained by housing structure, a large-scale cluster-randomized trial of insecticide treated curtains (ITCs) and water jar covers (ITJCs) was undertaken in Venezuela.
METHODS


In Trujillo, Venezuela, 60 clusters (6223 houses total) were randomized so that 15 clusters each received either PermaNet insecticide-treated window curtains (ITCs), permanent insecticide-treated water storage jar covers (ITJCs), a combination of both ITCs and ITJCs, or no insecticide treated materials (ITMs). A further 15 clusters located at least 5km from the edge of the study site were selected to act as an external control. Entomological surveys were carried out immediately before and after intervention, and then at 6-month intervals over the following 27 months. The Breteau and House indices were used as primary outcome measures and ovitrap indices as secondary. Negative binomial regression models were used to compare cluster-level values of these indices between the trial arms.
RESULTS


Reductions in entomological indices followed deployment of all ITMs and throughout the trial, indices in the external control arm remained substantially higher than in the ITM study arms including the internal control. Comparing the ratios of between-arm means to summarise the entomological indices throughout the study, the combined ITC+ITJC intervention had the greatest impact on the indices, with a 63% difference in the pupae per person indices between the ITC+ITJC arm and the internal control. However, coverage had fallen below 60% by 14-months post-intervention and remained below 40% for most of the remaining study period.
CONCLUSIONS


ITMs can impact dengue vector populations in the long term, particularly when ITCs and ITJCs are deployed in combination.
TRIAL REGISTRATION


ClinicalTrials.gov ISRCTN08474420; www.isrctn.com.",2022,"RESULTS


Reductions in entomological indices followed deployment of all ITMs and throughout the trial, indices in the external control arm remained substantially higher than in the ITM study arms including the internal control.","['In Trujillo, Venezuela, 60 clusters (6223 houses total) were randomized so that 15 clusters each received either']","['insecticide treated window curtains and water container covers', 'insecticide treated curtains (ITCs) and water jar covers (ITJCs', 'PermaNet insecticide-treated window curtains (ITCs), permanent insecticide-treated water storage jar covers (ITJCs), a combination of both ITCs and ITJCs, or no insecticide treated materials (ITMs']",[],"[{'cui': 'C0042469', 'cui_str': 'Venezuela'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0021576', 'cui_str': 'Insecticide'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0180239', 'cui_str': 'Curtain'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0180098', 'cui_str': 'Container'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0181427', 'cui_str': 'Jar'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0520510', 'cui_str': 'Material'}]",[],,0.0606195,"RESULTS


Reductions in entomological indices followed deployment of all ITMs and throughout the trial, indices in the external control arm remained substantially higher than in the ITM study arms including the internal control.","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Lenhart', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Carmen Elena', 'Initials': 'CE', 'LastName': 'Castillo', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Elci', 'Initials': 'E', 'LastName': 'Villegas', 'Affiliation': 'Universidad de los Andes, Núcleo Rafael Rangel, Instituto Experimental Jose Witremundo Torrealba, Trujillo, Venezuela.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'MRC International Statistics and Epidemiology Group, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Vanlerberghe', 'Affiliation': 'Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'van der Stuyft', 'Affiliation': 'Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'McCall', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0010135']
3309,35245262,Effects of a Caregiver Educational Program on Interactions between Family Caregivers and Patients with Advanced COPD.,"The quality of family caregiver-patient interaction plays a crucial role in the context of chronic conditions. This study investigated the effects of a caregiver educational program on interactions between family caregivers and patients with advanced chronic obstructive pulmonary disease (COPD). In this trial, 92 pairs of family caregivers and patients in a subspecialty lung care clinic located in Birjand, Iran were allocated into intervention and control groups (n = 46 per group). The intervention consisted of eight sessions, including three educational sessions on COPD, two educational sessions on coping strategies, as well as three peer support sessions. The Dyadic Relationship Scale was completed at baseline, posttest, and follow-up (2 months after intervention). For caregivers in the intervention group, positive dyadic interaction improved significantly from baseline to follow-up and from posttest to follow-up in comparison with the control group (p < 0.05). Also, for these caregivers, negative dyadic strain enhanced significantly from baseline to posttest and from baseline to follow-up as compared with those in the control group (p < 0.05). Finally, in patients of the intervention group, negative dyadic strain from baseline to follow-up and from posttest to follow-up significantly improved when compared with that of control patients (p < 0.05).",2022,"For caregivers in the intervention group, positive dyadic interaction improved significantly from baseline to follow-up and from posttest to follow-up in comparison with the control group (p < 0.05).","['92 pairs of family caregivers and patients in a subspecialty lung care clinic located in Birjand, Iran', 'family caregivers and patients with advanced chronic obstructive pulmonary disease (COPD', 'Family Caregivers and Patients with Advanced COPD']","['Caregiver Educational Program', 'caregiver educational program']","['negative dyadic strain', 'Dyadic Relationship Scale', 'positive dyadic interaction']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",92.0,0.0482208,"For caregivers in the intervention group, positive dyadic interaction improved significantly from baseline to follow-up and from posttest to follow-up in comparison with the control group (p < 0.05).","[{'ForeName': 'Seyyed Abolfazl', 'Initials': 'SA', 'LastName': 'Vagharseyyedin', 'Affiliation': ''}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Arbabi', 'Affiliation': ''}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Rahimi', 'Affiliation': ''}, {'ForeName': 'Sayyed Gholamreza Mortazavi', 'Initials': 'SGM', 'LastName': 'Moghaddam', 'Affiliation': ''}]",Home healthcare now,['10.1097/NHH.0000000000001049']
3310,35245251,Multicenter Randomized Clinical Trial Outcomes Reported This Month in Optometry and Vision Science.,,2022,,[],[],[],[],[],[],,0.483826,,"[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Twa', 'Affiliation': 'Editor in Chief University of Houston College of Optometry Houston, TX.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001882']
3311,35245227,Cancer-Related Fatigue: A Pilot Study Evaluating the Effect of Frankincense Essential Oil in Patients With Cancer Receiving Chemotherapy.,"BACKGROUND


Increasingly, patients with cancer are using essential oils as a complementary therapy to reduce the adverse effects of cancer treatment, such as fatigue. Although essential oils have few adverse effects, little is known about the effectiveness of individual oils for specific symptoms. Frankincense is one such oil that has been identified as a possible supportive therapy for cancer-related fatigue.
OBJECTIVE


The aim of this study was to determine if frankincense applied to the soles of the feet before, during, and after chemotherapy affects patients' perceptions of chemotherapy-related fatigue compared with control (carrier oil without frankincense).
METHODS


Randomized clinical trial in which participants were blinded to treatment condition. The main outcome variable was fatigue.
RESULTS


Seventy patients undergoing chemotherapy for cancer were randomized to apply frankincense or control oil to their feet twice a day 2 days before receiving chemotherapy, while receiving chemotherapy, and 2 days after chemotherapy. No statistically significant changes in fatigue were found over time or between groups. Baseline fatigue was the only predictor of posttreatment fatigue.
CONCLUSIONS


Although no statistically significant changes in fatigue were found over time or between groups, important insights were gained that can inform the design of future research.
IMPLICATIONS FOR PRACTICE


The use of essential oils as a complementary therapy to reduce adverse effects of cancer treatment is gaining popularity, and nurses may receive questions about the use of essential oils. No evidence to support the use of frankincense in the treatment of fatigue in patients receiving chemotherapy was found in this study.",2022,No statistically significant changes in fatigue were found over time or between groups.,"[""patients' perceptions of chemotherapy-related fatigue compared with control (carrier oil without frankincense"", 'Cancer-Related Fatigue', 'Patients With Cancer Receiving Chemotherapy', 'patients receiving', 'Seventy patients undergoing chemotherapy for cancer', 'patients with cancer']","['chemotherapy', 'Frankincense Essential Oil']","['Baseline fatigue', 'fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0949991', 'cui_str': 'Boswellia sacra'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0949991', 'cui_str': 'Boswellia sacra'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",70.0,0.207939,No statistically significant changes in fatigue were found over time or between groups.,"[{'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Reis', 'Affiliation': 'Author Affiliations: ProMedica Cancer Institute, Flower Hospital, Sylvania (Ms Reis and Ms Keller); ProMedica, Toledo (Ms Throne and Dr Koffel); and Department of Mathematics and Statistics, University of Toledo (Dr Chen), Ohio; and University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences (Dr Young-McCaughan).'}, {'ForeName': 'Tisha', 'Initials': 'T', 'LastName': 'Throne', 'Affiliation': ''}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Keller', 'Affiliation': ''}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Koffel', 'Affiliation': ''}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000001080']
3312,35240330,"Efficacy and Acceptability of Dietary Therapies in Non-Constipated Irritable Bowel Syndrome: A Randomized Trial of Traditional Dietary Advice, the Low FODMAP Diet and the Gluten-Free Diet.","BACKGROUND & AIMS


Various diets are proposed as first-line therapies for non-constipated irritable bowel syndrome (IBS) despite insufficient or low-quality evidence. We performed a randomized trial comparing traditional dietary advice (TDA) against the low FODMAP diet (LFD) and gluten-free diet (GFD).
METHODS


Patients with Rome IV-defined non-constipated IBS were randomized to TDA, LFD, or a GFD (the latter allowing for minute gluten cross-contamination). The primary endpoint was clinical response after 4 weeks of dietary intervention, as defined by ≥50-point reduction in IBS symptom severity score (IBS-SSS). Secondary endpoints included i) changes in individual IBS-SSS items within clinical responders, ii) acceptability and food-related quality of life with dietary therapy, iii) changes in nutritional intake, iv) alterations in stool dysbiosis index, and v) baseline factors associated with clinical response.
RESULTS


The primary endpoint of ≥50-point reduction in IBS-SSS was met by 42% (n=14/33) undertaking TDA, 55% (n=18/33) for LFD, and 58% (n=19/33) for GFD; p=0.43. Responders had similar improvements in IBS-SSS items regardless of their allocated diet. Individuals found TDA cheaper (p<0.01), less time-consuming to shop (p<0.01), and easier to follow when eating out (p=0.03) than the GFD and LFD. TDA was also easier to incorporate into daily life than the LFD (p=0.02). Overall reductions in micro- and macro- nutrient intake did not significantly differ across the diets. However, the LFD group had the greatest reduction in total FODMAP content (27.7g/day pre-intervention to 7.6g/day at week 4) compared with the GFD (27.4/g/day to 22.4g/day) and TDA (24.9g/day to 15.2g/day); p<0.01. Alterations in stool dysbiosis index were similar across the diets, with 22-29% showing reduced dysbiosis, 35-39% no change, and 35-40% increased dysbiosis; p=0.99. Baseline clinical characteristics and stool dysbiosis index did not predict response to dietary therapy.
CONCLUSION


TDA, LFD and GFD are effective approaches in non-constipated IBS, but TDA is the most patient-friendly in terms of cost and convenience. We recommend TDA as the first-choice dietary therapy in non-constipated IBS, with a LFD and GFD reserved according to specific patient preferences and specialist dietetic input.",2022,"Individuals found TDA cheaper (p<0.01), less time-consuming to shop (p<0.01), and easier to follow when eating out (p=0.03) than the GFD and LFD.","['Non-Constipated Irritable Bowel Syndrome', 'Patients with Rome IV-defined non-constipated IBS']","['LFD', 'TDA, LFD', 'traditional dietary advice (TDA) against the low FODMAP diet (LFD) and gluten-free diet (GFD', 'TDA', 'Dietary Therapies', 'Traditional Dietary Advice, the Low FODMAP Diet and the Gluten-Free Diet']","['Efficacy and Acceptability', 'micro- and macro- nutrient intake', 'IBS-SSS', 'total FODMAP content', 'clinical response', '≥50-point reduction in IBS-SSS', 'stool dysbiosis index', 'IBS symptom severity score (IBS-SSS', 'i) changes in individual IBS-SSS items within clinical responders, ii) acceptability and food-related quality of life with dietary therapy, iii) changes in nutritional intake, iv) alterations in stool dysbiosis index, and v) baseline factors associated with clinical response']","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C4728066', 'cui_str': 'Low FODMAP diet'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3658208', 'cui_str': 'Dysbiosis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",,0.0430066,"Individuals found TDA cheaper (p<0.01), less time-consuming to shop (p<0.01), and easier to follow when eating out (p=0.03) than the GFD and LFD.","[{'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Rej', 'Affiliation': 'Academic Unit of Gastroenterology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK; Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Sanders', 'Affiliation': 'Academic Unit of Gastroenterology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK; Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Christian C', 'Initials': 'CC', 'LastName': 'Shaw', 'Affiliation': 'Academic Unit of Gastroenterology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Buckle', 'Affiliation': 'Academic Unit of Gastroenterology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Trott', 'Affiliation': 'Academic Unit of Gastroenterology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': 'Doncaster and Bassetlaw Hospitals NHS Trust, Armthorpe Road, Doncaster, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Aziz', 'Affiliation': 'Academic Unit of Gastroenterology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK; Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK. Electronic address: imran.aziz1@nhs.net.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2022.02.045']
3313,35240317,Inorganic nitrate supplementation and blood flow restricted exercise tolerance in post-menopausal women.,"Exercise tolerance appears to benefit most from dietary nitrate (NO 3 - ) supplementation when muscle oxygen (O 2 ) availability is low. Using a double-blind, randomized cross-over design, we tested the hypothesis that acute NO 3 -  supplementation would improve blood flow restricted exercise duration in post-menopausal women, a population with reduced endogenous nitric oxide bioavailability. Thirteen women (57-76 yr) performed rhythmic isometric handgrip contractions (10% MVC, 30 per min) during progressive forearm blood flow restriction (upper arm cuff gradually inflated 20 mmHg each min) on three study visits, with 7-10 days between visits. Approximately one week following the first (familiarization) visit, participants consumed 140 ml of NO 3 -  concentrated (9.7 mmol, 0.6 gm NO 3 - ) or NO 3 - depleted beetroot juice (placebo) on separate days (≥7 days apart), with handgrip exercise beginning 100 min post-consumption. Handgrip force recordings were analyzed to determine if NO 3 -  supplementation enhanced force development as blood flow restriction progressed. Nitrate supplementation increased plasma NO 3 -  (16.2-fold) and NO 2 -  (4.2-fold) and time to volitional fatigue (61.8 ± 56.5 sec longer duration vs. placebo visit; p = 0.03). Nitrate supplementation increased the rate of force development as forearm muscle ischemia progressed (p = 0.023 between 50 and 75% of time to fatigue) with non-significant effects thereafter (p = 0.052). No effects of nitrate supplementation were observed for mean duration of contraction or relaxation rates (all p > 0.150). These results suggest that acute NO 3 -  supplementation prolongs time-to-fatigue and speeds grip force development during progressive forearm muscle ischemia in postmenopausal women.",2022,No effects of nitrate supplementation were observed for mean duration of contraction or relaxation rates (all p > 0.150).,"['Thirteen women (57-76\u202fyr) performed', 'postmenopausal women', 'post-menopausal women']","['handgrip exercise beginning 100\u202fmin post-consumption', 'rhythmic isometric handgrip contractions (10% MVC, 30 per min) during progressive forearm blood flow restriction', 'NO 3 - depleted beetroot juice (placebo', 'Nitrate supplementation', 'Inorganic nitrate supplementation and blood flow restricted exercise tolerance', 'nitrate supplementation']","['NO 3 -  (16.2-fold) and NO 2 -  (4.2-fold) and time to volitional fatigue', 'plasma', 'mean duration of contraction or relaxation rates', 'rate of force development as forearm muscle ischemia progressed']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}]","[{'cui': 'C4319690', 'cui_str': '16.2'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1760774', 'cui_str': 'Structure of muscle of forearm'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]",,0.233914,No effects of nitrate supplementation were observed for mean duration of contraction or relaxation rates (all p > 0.150).,"[{'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Proctor', 'Affiliation': 'Penn State University, University Park, PA, USA; Penn State College of Medicine, Hershey, PA, USA. Electronic address: dnp3@psu.edu.'}, {'ForeName': 'Kristina A', 'Initials': 'KA', 'LastName': 'Neely', 'Affiliation': 'Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Swapan', 'Initials': 'S', 'LastName': 'Mookerjee', 'Affiliation': 'Bloomsburg University, Bloomsburg, PA, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Tucker', 'Affiliation': 'Penn State University, University Park, PA, USA.'}, {'ForeName': 'Yasina B', 'Initials': 'YB', 'LastName': 'Somani', 'Affiliation': 'Penn State University, University Park, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Flanagan', 'Affiliation': 'Penn State College of Medicine, Hershey, PA, USA; Penn State Hershey Family and Community Medicine, University Park, PA, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kim-Shapiro', 'Affiliation': 'Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Muller', 'Affiliation': 'University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Jin-Kwang Kim', 'Affiliation': 'Penn State University, University Park, PA, USA; Penn State College of Medicine, Hershey, PA, USA.'}]",Nitric oxide : biology and chemistry,['10.1016/j.niox.2022.02.004']
3314,35240291,"Role of resveratrol supplementation in regulation of glucose hemostasis, inflammation and oxidative stress in patients with diabetes mellitus type 2: A randomized, placebo-controlled trial.","OBJECTIVE


The objective was to determine the effects of resveratrol supplementation on glucose homeostasis, oxidative stress, inflammation and microRNAs expression in patients with diabetes mellitus type 2 on oral hypoglycemic drugs.
METHOD


This was a randomized, double blinded placebo-controlled parallel group trial. The diabetic patients (n=110) were randomly assigned either to resveratrol (n=55) and placebo (55) groups after informed consent and given once daily resveratrol 200mg and cellulose capsules respectively for 24 weeks. Fasting glucose, insulin, HbA1c, lipid profile, TNF- α, IL-6, hs-CRP, MDA & circulatory microRNAs were measured at start and end of 24- week intervention.
RESULTS


Out of 110 patients recruited, 94 patients completed the study comprising of 45 in resveratrol and 46 in placebo group. The resveratrol supplementation after 24 weeks was resulted in significant reduction [mean difference (95%CI)] of plasma glucose[-0.50(-0.94 to -0.06)], insulin[-1.31(-2.24 to -0.38)], homeostatic model assessment of insulin resistance[-0.83(-1.37 to -0.29)], malondialdehyde[-0.36(-0.61 to -0.11)], high sensitive-C-reactive protein[-0.35(-0.70 to -0.01)], tumor necrosis factor-alpha[-1.25(-1.90 to -0.61)] and interleukin-6[-1.99(-3.29 to -0.69)]. More than two-fold down regulation in miRNA-34a, miRNA-375, miRNA-21, miRNA-192 and up regulation in miRNA-126 and miRNA-132 expression was noted in patients receiving resveratrol as compared to placebo. No side effects were reported during the trial.
CONCLUSION


Resveratrol supplementation contributes in improvement of glycemic control by reducing insulin resistance. It has significant beneficial impact on chronic inflammation, oxidative stress and associated microRNA expression in diabetic patients. Thus, supplementation of resveratrol along with oral hypoglycemic agents may be useful in the reduction of diabetic associated complications.",2022,"The resveratrol supplementation after 24 weeks was resulted in significant reduction [mean difference (95%CI)] of plasma glucose[-0.50(-0.94 to -0.06)], insulin[-1.31(-2.24 to -0.38)], homeostatic model assessment of insulin resistance[-0.83(-1.37 to -0.29)], malondialdehyde[-0.36(-0.61 to -0.11)], high sensitive-C-reactive protein[-0.35(-0.70 to -0.01)], tumor necrosis factor-alpha[-1.25(-1.90 to -0.61)] and interleukin-6[-1.99(-3.29 to -0.69)].","['diabetic patients (n=110', 'patients with diabetes mellitus type 2 on oral hypoglycemic drugs', '110 patients recruited', 'patients with diabetes mellitus type 2', 'diabetic patients', '94 patients completed the study comprising of 45 in resveratrol and 46 in placebo group']","['resveratrol supplementation', 'Resveratrol supplementation', 'placebo']","['side effects', 'glucose homeostasis, oxidative stress, inflammation and microRNAs expression', 'glucose hemostasis, inflammation and oxidative stress', 'Fasting glucose, insulin, HbA1c, lipid profile, TNF- α, IL-6, hs-CRP, MDA & circulatory microRNAs', 'miRNA-34a, miRNA-375, miRNA-21, miRNA-192 and up regulation in miRNA-126 and miRNA-132 expression']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0470256', 'cui_str': '126'}]",110.0,0.380625,"The resveratrol supplementation after 24 weeks was resulted in significant reduction [mean difference (95%CI)] of plasma glucose[-0.50(-0.94 to -0.06)], insulin[-1.31(-2.24 to -0.38)], homeostatic model assessment of insulin resistance[-0.83(-1.37 to -0.29)], malondialdehyde[-0.36(-0.61 to -0.11)], high sensitive-C-reactive protein[-0.35(-0.70 to -0.01)], tumor necrosis factor-alpha[-1.25(-1.90 to -0.61)] and interleukin-6[-1.99(-3.29 to -0.69)].","[{'ForeName': 'Wajiha', 'Initials': 'W', 'LastName': 'Mahjabeen', 'Affiliation': 'Pathology department, Armed Forces Institute of Pathology, National University of Medical Sciences, Rawalpindi.'}, {'ForeName': 'Dilshad Ahmed', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Pathology department, Armed Forces Institute of Pathology, National University of Medical Sciences, Rawalpindi. Electronic address: dakhan@cpsp.edu.pk.'}, {'ForeName': 'Shakil Ahmed', 'Initials': 'SA', 'LastName': 'Mirza', 'Affiliation': 'Consultant Physician, Mega Medical Complex Hospital, The Mall, Rawalpindi, Pakistan.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2022.102819']
3315,35240285,Comparison of AP Axis versus Transepicondylar Axis in Patients Undergoing Simultaneous Bilateral Total Knee Arthroplasty: One Technique per Knee.,"BACKGROUND


In primary Total Knee Arthroplasty (TKA), the preferred reference line for setting femoral component rotation, is debatable. This study compared the AP Axis Line (APAL) versus the Trans Epicondylar Axis Line (TEAL) in patients undergoing simultaneous bilateral TKA using a measured resection technique where one reference line was randomized to each knee.
METHODS


This prospective study compared the two reference lines utilizing posterior knee referencing with a cemented posterior stabilized knee. The study included 32 patients with osteoarthritis with both knees having similar varus knee deformities. All patients had the same surgical procedure with the only change being the selected femoral rotation axis line. Patients were followed for a minimum of two years.
RESULTS


There was no significant difference in any of the measured radiographic, operative, and clinical parameters, except for postoperative radiographic limb alignment (APAL 179.7° vs TEAL 180.1° p=0.04). The mean femoral external rotation relative to the Posterior Condylar Axis Line (PCAL) was 3.0 degrees (0-7 degrees) using the APAL, and 3.3 degrees (2-7 degrees) using the TEAL (p=0.46). Two-year knee flexion and Revised Oxford Knee Scores showed no difference. Seventy-five percent of patients stated no preference for either knee technique.
CONCLUSION


When using a measured resection, posterior referencing technique, we found no difference in knee function and scores when setting femoral component rotation using the APAL versus TEAL.",2022,"There was no significant difference in any of the measured radiographic, operative, and clinical parameters, except for postoperative radiographic limb alignment (APAL 179.7° vs TEAL 180.1° p=0.04).","['32 patients with osteoarthritis with both knees having similar varus knee deformities', 'two reference lines utilizing posterior knee referencing with a cemented posterior stabilized knee', 'primary Total Knee Arthroplasty (TKA', 'Patients Undergoing Simultaneous Bilateral Total Knee Arthroplasty', 'All patients had the same surgical procedure with the only change being the selected femoral rotation axis line', 'patients undergoing simultaneous bilateral TKA using a measured resection technique where one reference line was randomized to each knee']","['AP Axis versus Transepicondylar Axis', 'AP Axis Line (APAL) versus the Trans Epicondylar Axis Line (TEAL']","['knee function and scores', 'measured radiographic, operative, and clinical parameters, except for postoperative radiographic limb alignment', 'mean femoral external rotation relative to the Posterior Condylar Axis Line (PCAL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0230434', 'cui_str': 'Both knees'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0576091', 'cui_str': 'Deformity of knee joint'}, {'cui': 'C0458342', 'cui_str': 'Anatomical reference line'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",32.0,0.0425745,"There was no significant difference in any of the measured radiographic, operative, and clinical parameters, except for postoperative radiographic limb alignment (APAL 179.7° vs TEAL 180.1° p=0.04).","[{'ForeName': 'Sachin R', 'Initials': 'SR', 'LastName': 'Tapasvi', 'Affiliation': 'Department of Arthroplasty and Arthroscopy, The Orthopaedic Specialty Clinic, Pune, Maharashtra, India.'}, {'ForeName': 'Anshu', 'Initials': 'A', 'LastName': 'Shekhar', 'Affiliation': 'Department of Arthroplasty and Arthroscopy, The Orthopaedic Specialty Clinic, Pune, Maharashtra, India.'}, {'ForeName': 'Madhav', 'Initials': 'M', 'LastName': 'Chowdhry', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Kellogg College, University of Oxford, UK.'}, {'ForeName': 'Matthew V', 'Initials': 'MV', 'LastName': 'Dipane', 'Affiliation': 'David Geffen School of Medicine at UCLA, Dept. of Orthopaedic Surgery, Los Angeles, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'McPherson', 'Affiliation': 'David Geffen School of Medicine at UCLA, Dept. of Orthopaedic Surgery, Los Angeles, USA. Electronic address: edmcpherson@gmail.com.'}]",The Journal of arthroplasty,['10.1016/j.arth.2022.02.097']
3316,35240577,Does Physical Conditioning Influence Performance Attenuation and Recovery in Gaelic Football?,"PURPOSE


This study investigated the influence of components of fitness on measures of performance attenuation and recovery following Gaelic football match play.
METHODS


Measurements of players' anthropometric characteristics, body composition, running speed, lower-body strength and power, blood lactate concentrations, running economy, and maximal aerobic capacity (V˙O2max) were taken over 2 separate days 1 week prior to a competitive match. Creatine kinase, countermovement jump height, drop jump height, contact time, reactive strength index, and perceptual responses were tested prematch, at full time, 24 hours postmatch, and 48 hours postmatch.
RESULTS


Multiple components of fitness were associated with reduced performance attenuation and improved recovery responses (adjusted R2 = 9.8%-27.6%; P < .05). Players were divided into higher-standard and lower-standard V˙O2max (higher standard: 57.4 [4.2] mL·kg-1·min-1; lower standard: 45.3 [3.8] mL·kg-1·min-1) and relative squat (higher standard: 1.46 [0.11] 1-repetition-maximum kg·body mass-1; lower standard: 1.20 [0.08] 1-repetition-maximum kg·body mass-1) groups. After adjusting for prematch baseline differences, there were significant differences between V˙O2max groups in drop jump height at 24 hours postmatch (ηp2=.078-.154; P < .05) and countermovement jump height at 48 hours postmatch (ηp2=.134; P < .05), where the lower-standard group displayed larger decrements. In addition, there were significant differences between relative squat groups at all postmatch time points in contact time (ηp2=.156-.194; P < .05) and reactive strength index (ηp2=.127-.223; P < .05) and in perceptual responses at 24 hours postmatch (ηp2=.152; P < .05), where the lower-standard group expressed larger decrements.
CONCLUSION


Coaches should prioritize the development of aerobic capacity and neuromuscular function as an effective method of reducing performance attenuation and enhancing recovery kinetics in Gaelic football.",2022,"RESULTS


Multiple components of fitness were associated with reduced performance attenuation and improved recovery responses (adjusted R2 = 9.8%-27.6%; P < .05).",[],[],"['recovery responses', 'countermovement jump height', 'perceptual responses', 'Creatine kinase, countermovement jump height, drop jump height, contact time, reactive strength index, and perceptual responses', 'reactive strength index', ""players' anthropometric characteristics, body composition, running speed, lower-body strength and power, blood lactate concentrations, running economy, and maximal aerobic capacity (V˙O2max""]",[],[],"[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",,0.0580685,"RESULTS


Multiple components of fitness were associated with reduced performance attenuation and improved recovery responses (adjusted R2 = 9.8%-27.6%; P < .05).","[{'ForeName': 'Lorcan S', 'Initials': 'LS', 'LastName': 'Daly', 'Affiliation': ''}, {'ForeName': 'Ciarán', 'Initials': 'C', 'LastName': 'Ó Catháin', 'Affiliation': ''}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Kelly', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2021-0342']
3317,35240576,Effect of Acetaminophen on Endurance Cycling Performance in Trained Triathletes in Hot and Humid Conditions.,"PURPOSE


The effect of acetaminophen (ACT, also known as paracetamol) on endurance performance in hot and humid conditions has been shown previously in recreationally active populations. The aim of this study was to determine the effect of ACT on physiological and perceptual variables during steady-state and time-trial cycling performance of trained triathletes in hot and humid conditions.
METHODS


In a randomized, double-blind crossover design, 11 triathletes completed ∼60 minutes steady-state cycling at 63% peak power output followed by a time trial (7 kJ·kg body mass-1, ∼30 min) in hot and humid conditions (∼30°C, ∼69% relative humidity) 60 minutes after consuming either 20 mg·kg body mass-1 ACT or a color-matched placebo. Time-trial completion time, gastrointestinal temperature, skin temperature, thermal sensation, thermal comfort, rating of perceived exertion, and fluid balance were recorded throughout each session.
RESULTS


There was no difference in performance in the ACT trial compared with placebo (P = .086, d = 0.57), nor were there differences in gastrointestinal and skin temperature, thermal sensation and comfort, or fluid balance between trials.
CONCLUSION


In conclusion, there was no effect of ACT (20 mg·kg body mass-1) ingestion on physiology, perception, and performance of trained triathletes in hot and humid conditions, and existing precooling and percooling strategies appear to be more appropriate for endurance cycling performance in the heat.",2022,"There was no difference in performance in the ACT trial compared with placebo (P = .086, d = 0.57), nor were there differences in gastrointestinal and skin temperature, thermal sensation and comfort, or fluid balance between trials.
","['11 triathletes completed', 'trained triathletes in hot and humid conditions', 'Trained Triathletes in Hot and Humid Conditions']","['20\xa0mg·kg body mass-1 ACT or a color-matched placebo', 'placebo', 'ACT', 'Acetaminophen', 'paracetamol', 'acetaminophen (ACT', '∼60\xa0minutes steady-state cycling at 63% peak power output followed by a time trial (7\xa0kJ·kg body mass-1, ∼30\xa0min) in hot and humid conditions (∼30°C, ∼69% relative humidity']","['Time-trial completion time, gastrointestinal temperature, skin temperature, thermal sensation, thermal comfort, rating of perceived exertion, and fluid balance', 'gastrointestinal and skin temperature, thermal sensation and comfort, or fluid balance', 'endurance performance', 'Endurance Cycling Performance']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0428696', 'cui_str': 'Relative humidity'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",,0.33244,"There was no difference in performance in the ACT trial compared with placebo (P = .086, d = 0.57), nor were there differences in gastrointestinal and skin temperature, thermal sensation and comfort, or fluid balance between trials.
","[{'ForeName': 'Gyan A', 'Initials': 'GA', 'LastName': 'Wijekulasuriya', 'Affiliation': ''}, {'ForeName': 'Vernon G', 'Initials': 'VG', 'LastName': 'Coffey', 'Affiliation': ''}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Badham', 'Affiliation': ''}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': ""O'Connor"", 'Affiliation': ''}, {'ForeName': 'Avish P', 'Initials': 'AP', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Gregory R', 'Initials': 'GR', 'LastName': 'Cox', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2021-0475']
3318,35240552,"Effects of subthreshold electrical stimulation with white noise, pink noise, and chaotic signals on postural control during quiet standing.","BACKGROUND


The stochastic resonance (SR) phenomenon has been used to improve postural control through the application of imperceptible noise to the somatosensory system. White noise signals have been applied in numerous SR studies on postural control. However, because the SR effect depends on the noise structure, the stimulation effects of signals with different structures, such as pink noise and chaotic signals, on postural control, must be determined to achieve better clinical applications of SR technology.
RESEARCH QUESTION


During quiet standing, how is postural control affected by subthreshold electrical stimulation to the knee joints when signals with different structures (white noise, pink noise, and chaotic signals) are used?
METHODS


Sixteen healthy young adults stood quietly for 40 s with their eyes closed. To evaluate postural sway, we calculated the mean velocity, root mean square (CoP RMS ), and range (CoP Range ) values for the center of pressure (CoP) in the anteroposterior direction. The standing task was conducted under subthreshold electrical stimulation with white noise, pink noise, and chaotic signals based on the Lorenz system, in addition to the no-stimulation condition. The four stimulation conditions were randomized within each set and repeated seven times.
RESULTS


Significant effects of stimulation were observed in the CoP RMS  and CoP Range  values. The CoP RMS  value under the pink noise signal was significantly lower than that under the no-stimulation condition. The CoP Range  value also tended to decrease under the pink noise signal compared with the no-stimulation condition; however, the differences were not statistically significant. No significant changes were found with the white noise and chaotic signals compared with the no-stimulation condition.
SIGNIFICANCE


We demonstrated that the pink noise signal was more effective in reducing postural sway than the white noise and chaotic signals based on the Lorenz system during quiet standing.",2022,"No significant changes were found with the white noise and chaotic signals compared with the no-stimulation condition.
","['Sixteen healthy young adults stood quietly for 40\xa0s with their eyes closed', 'postural control during quiet standing']","['subthreshold electrical stimulation with white noise, pink noise, and chaotic signals']","['pink noise signal', 'white noise and chaotic signals', 'CoP RMS  and CoP Range  values', 'CoP RMS  value under the pink noise signal', 'postural sway', 'mean velocity, root mean square (CoP RMS ), and range (CoP Range ) values for the center of pressure (CoP']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]","[{'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205278', 'cui_str': 'Postural'}]",16.0,0.02621,"No significant changes were found with the white noise and chaotic signals compared with the no-stimulation condition.
","[{'ForeName': 'Momoko', 'Initials': 'M', 'LastName': 'Yamagata', 'Affiliation': 'Graduate School of Human Development and Environment, Kobe University, 3-11 Tsurukabuto, Nada-ku, Kobe, Hyogo 657-8501, Japan; Graduate School of Medicine, Kyoto University, 53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan; Research Fellow of the Japan Society for the Promotion of Science, 5-3-1 Kojimachi, Chiyoda-ku, Tokyo 102-0083, Japan. Electronic address: myamagata@people.kobe-u.ac.jp.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Okada', 'Affiliation': 'Faculty of Science and Engineering, Ritsumeikan University, 1-1-1 Noji-higashi, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Yukiho', 'Initials': 'Y', 'LastName': 'Tsujioka', 'Affiliation': 'Graduate School of Human Development and Environment, Kobe University, 3-11 Tsurukabuto, Nada-ku, Kobe, Hyogo 657-8501, Japan.'}, {'ForeName': 'Arisa', 'Initials': 'A', 'LastName': 'Takayama', 'Affiliation': 'Graduate School of Science and Engineering, Ritsumeikan University, 1-1-1 Noji-higashi, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Naruhiro', 'Initials': 'N', 'LastName': 'Shiozawa', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, 1-1-1 Noji-higashi, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Graduate School of Human Development and Environment, Kobe University, 3-11 Tsurukabuto, Nada-ku, Kobe, Hyogo 657-8501, Japan.'}]",Gait & posture,['10.1016/j.gaitpost.2022.02.023']
3319,35240988,Positive effects on activities of daily living one year after receiving comprehensive geriatric assessment - results from the randomised controlled study CGA-Swed.,"BACKGROUND


Today's acute hospital care is poorly adapted to the complex needs of frail older people. This exposes them to avoidable risks, such as loss of functional capacities, leading to unnecessary health and social care needs. Being frail and in need of acute hospital care often leads to higher dependence in Activities of Daily Living (ADL), especially if one's needs are not acknowledged. Comprehensive Geriatric Assessment (CGA) is one way to meet frail older people's complex needs. The study's aim was to investigate the effects on frail older people's ADL 12 months after receiving CGA.
METHODS


This is a two-armed randomised controlled intervention study. Participants were frail older people (75+) who sought the emergency department and needed admission to a medical ward. The intervention was CGA performed at a geriatric management unit during the hospital stay. The CGA included comprehensive assessment of medical, functional, psychological, social, and environmental status as well as treatment, rehabilitation, discharge planning, and follow-up. Multidisciplinary teamwork and a person-centred approach were used. The control was care at an ordinary medical hospital ward. The primary outcome was change in dependence in ADL from 2 weeks before admission to the 12-month follow-up.
RESULTS


At admission, 155 people participated (77 in the control, 78 in the intervention). At the 12-month follow-up, 78 participated (40 in the control, 38 in the intervention). Attrition was mainly due to mortality. Four participants in the control (5.2%) and twelve in the intervention group (15.4%) had improved in their ADL 1 year after discharge (OR = 3.32; 95% CI = 1.02-10.79).
CONCLUSIONS


In-hospital CGA performed at a geriatric management unit improves frail older people's ADL. Being less dependent in ADL increases frail older people's ability to remain in their own housing, which is important for both the individual and society.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02773914 . Retrospectively registered 16 May 2016.",2022,"Being frail and in need of acute hospital care often leads to higher dependence in Activities of Daily Living (ADL), especially if one's needs are not acknowledged.","[""frail older people's ADL"", ""frail older people's ADL 12\u2009months after receiving CGA"", '155 people participated (77 in the control, 78 in the intervention', 'Participants were frail older people (75+) who sought the emergency department and needed admission to a medical ward', 'frail older people']",['Comprehensive Geriatric Assessment (CGA'],"['change in dependence in ADL', 'comprehensive assessment of medical, functional, psychological, social, and environmental status as well as treatment, rehabilitation, discharge planning, and follow-up']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0017463', 'cui_str': 'Geriatric screening'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0012622', 'cui_str': 'Discharge planning'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.0564812,"Being frail and in need of acute hospital care often leads to higher dependence in Activities of Daily Living (ADL), especially if one's needs are not acknowledged.","[{'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Wilhelmson', 'Affiliation': 'Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Box 455, 405 30, Gothenburg, Sweden. katarina.wilhelmson@gu.se.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Andersson Hammar', 'Affiliation': 'Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Box 455, 405 30, Gothenburg, Sweden.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Westgård', 'Affiliation': 'Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Box 455, 405 30, Gothenburg, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Holmquist Henrikson', 'Affiliation': 'Department of Acute Medicine and Geriatrics, The Sahlgrenska University Hospital, Region Västra Götaland, 413 45, Gothenburg, Sweden.'}, {'ForeName': 'Synneve', 'Initials': 'S', 'LastName': 'Dahlin-Ivanoff', 'Affiliation': 'Centre of Aging and Health-AGECAP, University of Gothenburg, Gothenburg, Sweden.'}]",BMC geriatrics,['10.1186/s12877-022-02862-6']
3320,35240768,The use of tranexamic acid to reduce blood loss in uncemented total hip arthroplasty for avascular necrosis of femoral head: a prospective blinded randomized controlled study.,"BACKGROUND


The purpose of this prospective, double-blinded, randomized controlled study is to assess the efficacy of administration of intravenous tranexamic acid (TXA) for reducing blood loss in uncemented total hip arthroplasty (THA) for the treatment of osteonecrosis of femoral head.
METHODS


Between April 2012 and March 2014, 73 patients with avascular necrosis of femoral head were treated in our center. The patients were randomized and allocated to study group (n = 36; treated with TXA) and control group (n = 37). Intra- and postoperative blood loss, blood transfusion, and incidence of deep vein thrombosis were assessed. A p value less than 0.05 was considered statistically significant.
RESULTS


The intraoperative, postoperative, and total (clinical method and Gross' formula) blood loss were significantly greater in the control group (p < 0.05). On the first, second, and third postoperative days, the levels of hemoglobin and hematocrit were significantly better in the study group (p < 0.05). There was a significantly greater number of patients who required blood transfusion in the control group (p = .027). Deep vein thrombosis was not found in either group.
CONCLUSIONS


A single dose of TXA used preoperatively may minimize intraoperative, postoperative, and total blood loss in uncemented THA for the treatment of osteonecrosis of femoral head, and may not increase the risk of prothrombotic complications.",2019,There was a significantly greater number of patients who required blood transfusion in the control group (p = .027).,"['uncemented total hip arthroplasty (THA', 'uncemented total hip arthroplasty for avascular necrosis of femoral head', 'osteonecrosis of femoral head', 'Between April 2012 and March 2014, 73 patients with avascular necrosis of femoral head were treated in our center']","['TXA', 'tranexamic acid', 'intravenous tranexamic acid (TXA']","['blood loss', 'Intra- and postoperative blood loss, blood transfusion, and incidence of deep vein thrombosis', 'number of patients\xa0who required blood transfusion', 'Deep vein thrombosis', 'levels of hemoglobin and hematocrit', ""intraoperative, postoperative, and total (clinical method and Gross' formula) blood loss"", 'total blood loss']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}]",73.0,0.0633345,There was a significantly greater number of patients who required blood transfusion in the control group (p = .027).,"[{'ForeName': 'Javahir A', 'Initials': 'JA', 'LastName': 'Pachore', 'Affiliation': 'Department of Hip Arthroplasty, Shalby Hospitals, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Vikram Indrajit', 'Initials': 'VI', 'LastName': 'Shah', 'Affiliation': 'Department of Knee and Hip Arthroplasty, Shalby Hospitals, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Upadhyay', 'Affiliation': 'Department of Orthopaedics, NSCB Medical College, Jabalpur, MP, India. drsachinupadhyay@gmail.com.'}, {'ForeName': 'Kalpesh', 'Initials': 'K', 'LastName': 'Shah', 'Affiliation': 'Department of Knee and Hip Arthroplasty, Shalby Hospitals, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sheth', 'Affiliation': 'Department of Knee and Hip Arthroplasty, Shalby Hospitals, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Amish', 'Initials': 'A', 'LastName': 'Kshatriya', 'Affiliation': 'Department of Knee and Hip Arthroplasty, Shalby Hospitals, Ahmedabad, Gujarat, India.'}]","Arthroplasty (London, England)",['10.1186/s42836-019-0012-6']
3321,35241222,2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients.,"BACKGROUND


The Evolut Low Risk Trial (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients) showed that transcatheter aortic valve replacement (TAVR) with a supra-annular, self-expanding valve was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. This finding was based on a Bayesian analysis performed after 850 patients had reached 1 year of follow-up.
OBJECTIVES


The goal of this study was to report the full 2-year clinical and echocardiographic outcomes for patients enrolled in the Evolut Low Risk Trial.
METHODS


A total of 1,414 low-surgical risk patients with severe aortic stenosis were randomized to receive TAVR or surgical AVR. An independent clinical events committee adjudicated adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints.
RESULTS


An attempted implant was performed in 730 TAVR and 684 surgical patients from March 2016 to May 2019. The Kaplan-Meier rates for the complete 2-year primary endpoint of death or disabling stroke were 4.3% in the TAVR group and 6.3% in the surgery group (P = 0.084). These rates were comparable to the interim Bayesian rates of 5.3% with TAVR and 6.7% with surgery (difference: -1.4%; 95% Bayesian credible interval: -4.9% to 2.1%). All-cause mortality rates were 3.5% vs 4.4% (P = 0.366), and disabling stroke rates were 1.5% vs 2.7% (P = 0.119), respectively. Between years 1 and 2, there was no convergence of the primary outcome curves.
CONCLUSIONS


The complete 2-year follow-up from the Evolut Low Risk Trial found that TAVR is noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke, with event rates that were slightly better than those predicted by using the Bayesian analysis. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients [Evolut Low Risk Trial]; NCT02701283).",2022,"All-cause mortality rates were 3.5% vs 4.4% (P = 0.366), and disabling stroke rates were 1.5% vs 2.7% (P = 0.119), respectively.","['1,414 low-surgical risk patients with severe aortic stenosis', '730 TAVR and 684 surgical patients from March 2016 to May 2019', 'Low Risk Patients', '850 patients had reached 1 year of follow-up', 'Low-Risk Patients', 'patients enrolled in the Evolut Low Risk Trial']","['Medtronic Evolut Transcatheter Aortic Valve Replacement', 'TAVR', 'Transcatheter Versus Surgical Aortic Valve Replacement', 'TAVR or surgical AVR', 'transcatheter aortic valve replacement (TAVR']","['mortality rates', 'disabling stroke rates', 'death or disabling stroke']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0449217', 'cui_str': 'aVR'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1414.0,0.224751,"All-cause mortality rates were 3.5% vs 4.4% (P = 0.366), and disabling stroke rates were 1.5% vs 2.7% (P = 0.119), respectively.","[{'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Forrest', 'Affiliation': 'Department of Internal Medicine (Cardiology), Yale University School of Medicine, New Haven, Connecticut, USA; Department of Surgery (Cardiac Surgery), Yale University School of Medicine, New Haven, Connecticut, USA. Electronic address: john.k.forrest@yale.edu.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Deeb', 'Affiliation': 'Department of Interventional Cardiology, University of Michigan Hospitals, Ann Arbor, Michigan, USA; Department of Cardiovascular Surgery, University of Michigan Hospitals, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Yakubov', 'Affiliation': 'Department of Interventional Cardiology, Riverside Methodist-OhioHealth, Columbus, Ohio, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Rovin', 'Affiliation': 'Department of Cardiac Surgery, Morton Plant Hospital, Clearwater, Florida, USA.'}, {'ForeName': 'Mubashir', 'Initials': 'M', 'LastName': 'Mumtaz', 'Affiliation': 'Department of Interventional Cardiology, University of Pittsburgh Medical Center Pinnacle, Wormleyburg, Pennsylvania, USA; Department of Cardiovascular and Thoracic Surgery, University of Pittsburgh Medical Center Pinnacle, Wormleyburg, Pennsylvania, USA.'}, {'ForeName': 'Hemal', 'Initials': 'H', 'LastName': 'Gada', 'Affiliation': 'Department of Interventional Cardiology, University of Pittsburgh Medical Center Pinnacle, Wormleyburg, Pennsylvania, USA; Department of Cardiovascular and Thoracic Surgery, University of Pittsburgh Medical Center Pinnacle, Wormleyburg, Pennsylvania, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': ""O'Hair"", 'Affiliation': ""Department of Interventional Cardiology, Aurora St. Luke's Medical Center, Milwaukee, Wisconsin, USA; Department of Cardiovascular Surgery, Aurora St. Luke's Medical Center, Milwaukee, Wisconsin, USA.""}, {'ForeName': 'Tanvir', 'Initials': 'T', 'LastName': 'Bajwa', 'Affiliation': ""Department of Interventional Cardiology, Aurora St. Luke's Medical Center, Milwaukee, Wisconsin, USA; Department of Cardiovascular Surgery, Aurora St. Luke's Medical Center, Milwaukee, Wisconsin, USA.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sorajja', 'Affiliation': 'Department of Interventional Cardiology, Minneapolis Heart Institute-Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Heiser', 'Affiliation': 'Department of Interventional Cardiology, Spectrum Health, Grand Rapids, Michigan, USA; Department of Cardiothoracic Surgery, Spectrum Health, Grand Rapids, Michigan, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Merhi', 'Affiliation': 'Department of Interventional Cardiology, Spectrum Health, Grand Rapids, Michigan, USA; Department of Cardiothoracic Surgery, Spectrum Health, Grand Rapids, Michigan, USA.'}, {'ForeName': 'Abeel', 'Initials': 'A', 'LastName': 'Mangi', 'Affiliation': 'Department of Internal Medicine (Cardiology), Yale University School of Medicine, New Haven, Connecticut, USA; Department of Surgery (Cardiac Surgery), Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Spriggs', 'Affiliation': 'Department of Cardiac Surgery, Morton Plant Hospital, Clearwater, Florida, USA.'}, {'ForeName': 'Neal S', 'Initials': 'NS', 'LastName': 'Kleiman', 'Affiliation': 'Department of Interventional Cardiology, Houston Methodist-DeBakey Heart and Vascular Center, Houston, Texas, USA; Department of Cardiothoracic Surgery, Houston Methodist-DeBakey Heart and Vascular Center, Houston, Texas, USA.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Chetcuti', 'Affiliation': 'Department of Interventional Cardiology, University of Michigan Hospitals, Ann Arbor, Michigan, USA; Department of Cardiovascular Surgery, University of Michigan Hospitals, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Teirstein', 'Affiliation': 'Department of Interventional Cardiology, Scripps Clinic, La Jolla, California, USA.'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Zorn', 'Affiliation': 'Department of Interventional Cardiology, University of Kansas, Kansas City, Kansas, USA; Department of Cardiac Surgery, University of Kansas, Kansas City, Kansas, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tadros', 'Affiliation': 'Department of Interventional Cardiology, University of Kansas, Kansas City, Kansas, USA; Department of Cardiac Surgery, University of Kansas, Kansas City, Kansas, USA.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchétché', 'Affiliation': 'Department of Interventional Cardiology, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Jon R', 'Initials': 'JR', 'LastName': 'Resar', 'Affiliation': 'Department of Interventional Cardiology, Johns Hopkins Hospital, Baltimore, Maryland, USA.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Walton', 'Affiliation': 'Department of Interventional Cardiology, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Gleason', 'Affiliation': 'Department of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Basel', 'Initials': 'B', 'LastName': 'Ramlawi', 'Affiliation': 'Department of Cardiovascular Surgery, Valley Health System, Winchester, Virginia, USA.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Iskander', 'Affiliation': ""Department of Interventional Cardiology, Saint Joseph's Hospital Health Center, Syracuse, New York, USA; Department of Cardiovascular Surgery, Saint Joseph's Hospital Health Center, Syracuse, New York, USA.""}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Caputo', 'Affiliation': ""Department of Interventional Cardiology, Saint Joseph's Hospital Health Center, Syracuse, New York, USA; Department of Cardiovascular Surgery, Saint Joseph's Hospital Health Center, Syracuse, New York, USA.""}, {'ForeName': 'Jae K', 'Initials': 'JK', 'LastName': 'Oh', 'Affiliation': 'Division of Cardiovascular Ultrasound, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Statistics, Medtronic, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Department of Interventional Cardiology, Houston Methodist-DeBakey Heart and Vascular Center, Houston, Texas, USA; Department of Cardiothoracic Surgery, Houston Methodist-DeBakey Heart and Vascular Center, Houston, Texas, USA.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2021.11.062']
3322,35241182,Protocol for a randomised controlled feasibility study examining the efficacy of brief cognitive therapy for the treatment of panic disorder in adolescents (PANDA).,"BACKGROUND


Panic disorder occurs in between 1 and 3% of adolescents, is associated with high levels of co-morbidity, and without treatment, appears to have a chronic course. To improve access to effective psychological interventions, briefer versions of cognitive behaviour therapy (CBT) have been developed and evaluated for preadolescent children with anxiety disorders. However, there are currently no brief evidence-based CBT interventions for adolescents with anxiety disorders that can be delivered in less than eight sessions. Given that a brief version of cognitive therapy has been shown to be effective in adults with panic disorder, it is possible that an adapted version could be effective for adolescents with panic disorder.
METHODS


The study will examine whether a definitive trial can be conducted, based on a single-centre feasibility randomised controlled trial using several well-defined criteria. Between 30 and 48 young people (age 11-18 years) who meet diagnostic criteria for panic disorder, attending a routine clinical service will be randomly allocated to receive either (i) brief cognitive therapy or (ii) a general form of CBT treatment that is more commonly used for adolescents with anxiety disorders. Both will be delivered 1:1 by a therapist and involve five treatment sessions and two booster sessions. Young people's outcomes will be assessed at the end of treatment and at 3-month follow-up, and qualitative interviews will be conducted to examine acceptability. We will also explore outcomes 1 year after the completion of treatment.
DISCUSSION


This study will test the feasibility of a randomised controlled trial to compare brief cognitive therapy to a general form of CBT for adolescents with panic disorder in the UK. The outputs from the study will provide a clear indication of the feasibility of a future definitive trial and, if indicated, the critical resources that will be required and key information to inform the design and maximise the successful completion of the trial. This has the potential to bring direct benefits to young people and their families, as well as services and society more broadly.
TRIAL REGISTRATION


This trial is registered on the ISRCTN Registry, registration number ISRCTN14884288 , registered retrospectively on 05/12/2019.",2022,"This has the potential to bring direct benefits to young people and their families, as well as services and society more broadly.
","['preadolescent children with anxiety disorders', 'Between 30 and 48 young people (age 11-18 years) who meet diagnostic criteria for panic disorder, attending a routine clinical service', 'adults with panic disorder', 'adolescents with panic disorder in the UK', 'adolescents with anxiety disorders', 'panic disorder in adolescents (PANDA', 'adolescents with panic disorder']","['CBT', 'CBT interventions', 'cognitive therapy or (ii) a general form of CBT treatment', 'cognitive therapy', 'cognitive behaviour therapy (CBT']",[],"[{'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0466285,"This has the potential to bring direct benefits to young people and their families, as well as services and society more broadly.
","[{'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Waite', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, RG6 6AL, UK. p.l.waite@reading.ac.uk.'}]",Pilot and feasibility studies,['10.1186/s40814-022-01009-z']
3323,35241176,Functional standing frame programme early after severe sub-acute stroke (SPIRES): a randomised controlled feasibility trial.,"BACKGROUND


Early mobilisation (> 24 h post-stroke) is recommended for people with stroke. However, there is a paucity of evidence about how to implement early mobilisation for people who have had a severe stroke. Prolonged standing and task-specific training (sit-to-stand repetitions) have separately been evaluated in the literature; however, these functionally linked tasks have not been evaluated in combination for people with severe sub-acute stroke.
METHODS


The objective was to determine the feasibility of conducting a randomised controlled trial (RCT) of a functional standing frame programme compared with usual physiotherapy for people with severe sub-acute stroke. An assessor-blinded feasibility RCT with nested qualitative component (interviews and focus group) and process evaluation was adopted. Participants were aged ≥ 18 years with new diagnosis of severe sub-acute stroke (modified Rankin Scale (mRS) 4/5) from four Stroke Rehabilitation Units across South West England. Participants were randomised to receive either: (1) functional standing frame programme (30 min. standing plus sit-to-stand repetitions) plus 15 min of usual physiotherapy daily (intervention); (2) usual physiotherapy (45 min) daily (control). Both programmes were protocolised to be undertaken a minimum of five sessions per week for 3 weeks. Feasibility indicators included process, resource, management, and safety. Adherence, fidelity, and acceptability of the trial and intervention were evaluated using data recorded by therapists, observation of intervention and control sessions, interviews and one focus group. Patient measures of motor impairment, activities/participation, and quality of life were carried out by blinded assessors at baseline, 3, 15, 29, and 55 weeks post-randomisation.
RESULTS


Forty-five participants (51-96 years; 42% male, mRS 4 = 80% 5 = 20%) were randomised (n = 22 to intervention). Twenty-seven (60%) participants were followed-up at all time points. Twelve participants (27%) died during the trial; no deaths were related to the trial. Adherence to the minimum number of sessions was low: none of the participants completed all 21 sessions, and only 8 participants (18%) across both groups completed ≥ 15 sessions, over the 3 weeks; 39% intervention; 51% control sessions were completed; mean session duration 39 min (SD 19) control, 37 min intervention (SD 11). Intervention group: mean standing time 13 min (SD 9); mean sit-to-stand repetitions/session 5 (SD 4). Interviews were conducted with 10 participants, four relatives and six physiotherapists. Five physiotherapists attended a focus group.
CONCLUSIONS


The majority of progression criteria for this feasibility trial were met. However, adherence to the interventions was unacceptably low. This aspect of the trial design needs to be addressed prior to moving to a definitive RCT of this standing frame intervention in people with severe sub-acute stroke. Solutions have been identified to address these concerns.
TRIAL REGISTRATION


International Standard Randomised Controlled Trial Number ISRCTN15412695 . Registration 19 December 2016.",2022,"Adherence to the minimum number of sessions was low: none of the participants completed all 21 sessions, and only 8 participants (18%) across both groups completed ≥ 15 sessions, over the 3 weeks; 39% intervention; 51% control sessions were completed; mean session duration 39 min (SD 19) control, 37 min intervention (SD 11).","['Participants were aged ≥ 18 years with new diagnosis of severe sub-acute stroke (modified Rankin Scale (mRS) 4/5) from four Stroke Rehabilitation Units across South West England', '10 participants, four relatives and six physiotherapists', 'people with stroke', 'people with severe sub-acute stroke', 'people who have had a severe stroke', 'after severe sub-acute stroke (SPIRES', 'Forty-five participants (51-96 years; 42% male, mRS 4 = 80% 5 = 20']","['Functional standing frame programme early', 'Prolonged standing and task-specific training (sit-to-stand repetitions', 'functional standing frame programme (30 min. standing plus sit-to-stand repetitions) plus 15 min of usual physiotherapy daily (intervention); (2) usual physiotherapy (45 min) daily (control', 'functional standing frame programme', 'usual physiotherapy']","['process, resource, management, and safety', 'Adherence, fidelity, and acceptability', 'mean standing time 13 min (SD 9); mean sit-to-stand repetitions/session', 'motor impairment, activities/participation, and quality of life']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0183500', 'cui_str': 'Standing frame'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",12.0,0.0793624,"Adherence to the minimum number of sessions was low: none of the participants completed all 21 sessions, and only 8 participants (18%) across both groups completed ≥ 15 sessions, over the 3 weeks; 39% intervention; 51% control sessions were completed; mean session duration 39 min (SD 19) control, 37 min intervention (SD 11).","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Logan', 'Affiliation': 'Faculty of Health, School of Health Professions, University of Plymouth, Plymouth, UK. angie.logan@nhs.net.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Faculty of Health, School of Health Professions, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Bridie', 'Initials': 'B', 'LastName': 'Kent', 'Affiliation': 'Faculty of Health, School of Health Professions, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Pooler', 'Affiliation': 'Faculty of Health, School of Health Professions, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Creanor', 'Affiliation': 'Peninsula Clinical Trials Unit, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Doyo', 'Initials': 'D', 'LastName': 'Enki', 'Affiliation': 'Faculty of Medicine & Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Vickery', 'Affiliation': 'Peninsula Clinical Trials Unit, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Barton', 'Affiliation': 'NIHR Research Design Service, Peninsula Schools of Medicine and Dentistry, Plymouth, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': 'Faculty of Health, School of Health Professions, University of Plymouth, Plymouth, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-022-01012-4']
3324,35241098,Coenzyme Q10 supplementation improves adipokine profile in dyslipidemic individuals: a randomized controlled trial.,"BACKGROUND


In previous study, we found that coenzyme Q10 (CoQ10) improved glucolipid profile in dyslipidemic individuals, but the mechanism is not yet clear. Adipokines have been demonstrated to be vital targets of metabolic diseases. The hypothesis that adipokines mediate the association of CoQ10 on glucolipid metabolism needs to be further studied in human.
METHODS


In this randomized, double-blinded, placebo-controlled trial, 101 dyslipidemic individuals were administrated to 120 mg CoQ10 or placebo for 24 weeks. Anthropometric parameters, glucolipid profile, serum total adiponectin, leptin, and resistin were evaluated at baseline, week 12 and week 24.
RESULTS


CoQ10 treatment significantly increased serum adiponectin levels at week 12 (165 [0, 362] ng/mL, p < 0.001) and at week 24 (523 [0, 1056] ng/mL, p < 0.001]), which was significant different compared with placebo (p < 0.001). The increase of adiponectin was negative associated with decrease in index of homeostasis model assessment of insulin resistance (HOMA-IR, r = - 0.465, p = 0.001), triglyceride (TG, r = - 0.297, p = 0.047), and low-density lipoprotein cholesterol (LDL-c, r = - 0.440, p = 0.002) at week 24 only in CoQ10-treated group. Resistin was reduced by CoQ10 only at week 24 (- 1.19 [- 4.35, 0.00] ng/mL, p < 0.001), which was significant different compared with placebo (p < 0.001). Reduction of resistin was positively correlated with the change in HOMA-IR (r = 0.343, p = 0.021) and TG (r = 0.323, p = 0.030) at week 24 in CoQ10-treated group but not placebo group. Leptin was not influenced by CoQ10 treatment. Mediation analysis indicated that the improvement of HOMA-IR, TG and LDL-c by CoQ10 was mediated by adiponectin but not resistin.
CONCLUSIONS


Our study shows that CoQ10 ameliorates glucolipid profile and adipokines dysfunction in dyslipidemic patients in 24 weeks' intervention. The beneficial effect of CoQ10 on glucolipid profile was mediated by adiponectin.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02407548. Registered on April 3, 2015, https://clinicaltrials.gov/ct2/show/NCT02407548 .",2022,"Mediation analysis indicated that the improvement of HOMA-IR, TG and LDL-c by CoQ10 was mediated by adiponectin but not resistin.
","[""dyslipidemic patients in 24\xa0weeks' intervention"", '101 dyslipidemic individuals', 'dyslipidemic individuals']","['CoQ10 or placebo', 'placebo', 'coenzyme Q10 (CoQ10', 'CoQ10', 'Coenzyme Q10 supplementation']","['Anthropometric parameters, glucolipid profile, serum total adiponectin, leptin, and resistin', 'serum adiponectin levels', 'HOMA-IR, TG and LDL-c by CoQ10', 'Resistin', 'adipokine profile', 'Reduction of resistin', 'low-density lipoprotein cholesterol', 'Leptin', 'index of homeostasis model assessment of insulin resistance (HOMA-IR', 'triglyceride', 'adiponectin', 'HOMA-IR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",101.0,0.452706,"Mediation analysis indicated that the improvement of HOMA-IR, TG and LDL-c by CoQ10 was mediated by adiponectin but not resistin.
","[{'ForeName': 'Peiwen', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Nutrition, School of Public Health, Guangdong Medical University, Dongguan, People's Republic of China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ""Department of Nutrition, School of Public Health, Sun Yat-Sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Taiping', 'Initials': 'T', 'LastName': 'He', 'Affiliation': ""Department of Nutrition, School of Public Health, Guangdong Medical University, Dongguan, People's Republic of China.""}, {'ForeName': 'Honghui', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': ""Department of Nutrition, School of Public Health, Guangdong Medical University, Dongguan, People's Republic of China. guohh1999@hotmail.com.""}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Nutrition, School of Public Health, Guangdong Medical University, Dongguan, People's Republic of China. chenx93@mail.sysu.edu.cn.""}]",Nutrition & metabolism,['10.1186/s12986-022-00649-5']
3325,35241087,"Activity and safety of SHR3680, a novel antiandrogen, in patients with metastatic castration-resistant prostate cancer: a phase I/II trial.","BACKGROUND


Antagonizing the androgen-receptor (AR) pathway is an effective treatment strategy for patients with metastatic castration-resistant prostate cancer (CRPC). Here, we report the results of a first-in-human phase 1/2 study which assessed the safety, pharmacokinetics, and activity of SHR3680 (a novel AR antagonist) in patients with metastatic CRPC.
METHODS


This phase 1/2 study enrolled patients with progressive metastatic CRPC who had not been previously treated with novel AR-targeted agents. In the phase 1 dose-escalation portion, patients received oral SHR3680 at a starting daily dose of 40 mg, which was subsequently escalated to 80 mg, 160 mg, 240 mg, 360 mg, and 480 mg per day. In phase 2 dose-expansion portion, patients were randomized to receive daily dose of 80 mg, 160 mg, or 240 mg of SHR3680. The primary endpoint in phase 1 was safety and tolerability and in phase 2 was the proportion of patients with a prostate-specific antigen (PSA) response (≥ 50% decrease of PSA level) at week 12.
RESULTS


A total of 197 eligible patients were enrolled and received SHR3680 treatment, including 18 patients in phase 1 and 179 patients in phase 2. No dose-limiting toxicities were reported and the maximum tolerated dose was not reached. Treatment-related adverse events (TRAEs) occurred in 116 (58.9%) patients, with the most common one being proteinuria (13.7%). TRAEs of grade ≥ 3 occurred in only 23 (11.7%) patients, and no treatment-related deaths occurred. Antitumor activities were evident at all doses, including PSA response at week 12 in 134 (68.0%; 95% CI, 61.0-74.5) patients, stabilized bone disease at week 12 in 174 (88.3%; 95% CI, 87.2-95.5) patients, and responses in soft tissue lesions in 21 (34.4%, 95% CI, 22.7-47.7) of 61 patients.
CONCLUSION


SHR3680 was well tolerated and safe, with promising anti-tumor activity across all doses tested in patients with metastatic CRPC. The dose of 240 mg daily was recommended for further phase 3 study.
TRIAL REGISTRATION


Clinical trials.gov NCT02691975; registered February 25, 2016.",2022,"Antitumor activities were evident at all doses, including PSA response at week 12 in 134 (68.0%; 95% CI, 61.0-74.5) patients, stabilized bone disease at week 12 in 174 (88.3%; 95% CI, 87.2-95.5) patients, and responses in soft tissue lesions in 21 (34.4%, 95% CI, 22.7-47.7) of 61 patients.
","['patients with metastatic castration-resistant prostate cancer', 'enrolled patients with progressive metastatic CRPC who had not been previously treated with novel AR-targeted agents', 'patients with metastatic castration-resistant prostate cancer (CRPC', 'patients with metastatic CRPC', '197 eligible patients were enrolled and received SHR3680 treatment, including 18 patients in phase 1 and 179 patients in phase 2']","['SHR3680', 'oral SHR3680']","['TRAEs of grade\u2009≥\u20093', 'No dose-limiting toxicities', 'proportion of patients with a prostate-specific antigen (PSA) response', 'soft tissue lesions', 'safety and tolerability', 'Antitumor activities', 'adverse events (TRAEs', 'PSA response', 'tolerated and safe', 'safety, pharmacokinetics, and activity of SHR3680', 'stabilized bone disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0410013', 'cui_str': 'Soft tissue lesion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0005940', 'cui_str': 'Disorder of bone'}]",197.0,0.0759019,"Antitumor activities were evident at all doses, including PSA response at week 12 in 134 (68.0%; 95% CI, 61.0-74.5) patients, stabilized bone disease at week 12 in 174 (88.3%; 95% CI, 87.2-95.5) patients, and responses in soft tissue lesions in 21 (34.4%, 95% CI, 22.7-47.7) of 61 patients.
","[{'ForeName': 'Xiaojian', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': ""Department of Urology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Shanghai, 200032, China.""}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Ji', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Gu', 'Affiliation': ""Department of Urology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Shanghai, 200032, China.""}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Department of Urology, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Hunan Cancer Center, Changsha, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Urology, Chongqing University Cancer Hospital, Chongqing Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Chuanjun', 'Initials': 'C', 'LastName': 'Du', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zou', 'Affiliation': 'Department of Urology, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Zhongquan', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Huadong Hospital Affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Chaohong', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Department of Urology, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Shaoxing', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Department of Urology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Tie', 'Initials': 'T', 'LastName': 'Chong', 'Affiliation': ""Department of Urology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': 'Department of Urology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Wan', 'Affiliation': 'Departmeint of Urology, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Xinfeng', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.'}, {'ForeName': 'Aobing', 'Initials': 'A', 'LastName': 'Bai', 'Affiliation': 'Department of Clinical Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Department of Clinical Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Department of Clinical Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.'}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': ""Department of Urology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Shanghai, 200032, China. dwyeli@163.com.""}]",BMC medicine,['10.1186/s12916-022-02263-x']
3326,35241086,Early life exposure to nicotine modifies lung gene response after elastase-induced emphysema.,"BACKGROUND


Chronic obstructive pulmonary disease (COPD) is among the top 5 causes of mortality in the world and can develop as a consequence of genetic and/or environmental factors. Current efforts are focused on identifying early life insults and how these contribute to COPD development. In line with this, our study focuses on the influence of early life nicotine exposure and its potential impact on (a) lung pulmonary functions, and (b) elastase-induced emphysema in adulthood.
METHODS


To address this hypothesis, we developed a model of 2 hits, delivered at different time points: mouse pups were first exposed to nicotine/placebo in utero and during lactation, and then subsequently received elastase/placebo at the age of 11 weeks. The effect of nicotine pretreatment and elastase instillation was assessed by (a) measurement of pulmonary function at post-elastase day (ped) 21, and (b) transcriptomic profiling at ped3 and 21, and complementary protein determination. Statistical significance was determined by 3- and 2-way ANOVA for pulmonary functions, and RNAseq results were analyzed using the R project.
RESULTS


We did not observe any impact of nicotine pre- and early post-natal exposure compared to control samples on lung pulmonary functions in adulthood, as measured by FLEXIVENT technology. After elastase instillation, substantial lung damage was detected by x-ray tomography and was accompanied by loss in body weight at ped3 as well as an increase in cell numbers, inflammatory markers in BAL and lung volume at ped21. Lung functions showed a decrease in elastance and an increase in deep inflation volume and pressure volume (pv) loop area in animals with emphysema at ped21. Nicotine had no effect on elastance and deep inflation volume, but did affect the pv loop area in animals with emphysema at ped21. Extensive transcriptomic changes were induced by elastase at ped3 both in the nicotine-pretreated and the control samples, with several pathways common to both groups, such as for cell cycle, DNA adhesion and DNA damage. Nicotine pretreatment affected the number of lymphocytes present in BAL after elastase instillation and some of the complement pathway related proteins, arguing for a slight modification of the immune response, as well as changes related to general body metabolism. The majority of elastase-induced transcriptomic changes detected at ped3 had disappeared at ped21. In addition, transcriptomic profiling singled out a common gene pool that was independently activated by nicotine and elastase.
CONCLUSIONS


Our study reports a broad spectrum of transient transcriptomic changes in mouse emphysema and identifies nicotine as influencing the emphysema-associated immune system response.",2022,"Nicotine pretreatment affected the number of lymphocytes present in BAL after elastase instillation and some of the complement pathway related proteins, arguing for a slight modification of the immune response, as well as changes related to general body metabolism.",['Chronic obstructive pulmonary disease (COPD'],"['nicotine', 'nicotine/placebo', 'elastase/placebo', 'Nicotine']","['body weight', 'deep inflation volume and pressure volume (pv) loop area', 'elastance and deep inflation volume', 'substantial lung damage']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030306', 'cui_str': 'Pancreatic elastase'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0428735', 'cui_str': 'Pressure volume loop'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]",,0.0210346,"Nicotine pretreatment affected the number of lymphocytes present in BAL after elastase instillation and some of the complement pathway related proteins, arguing for a slight modification of the immune response, as well as changes related to general body metabolism.","[{'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Blaskovic', 'Affiliation': 'Department of Pediatrics, Gynecology and Obstetrics, Faculty of Medicine, University of Geneva, 4 rue Gabrielle-Perret-Gentil, 1211, Genève 14, Switzerland.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Donati', 'Affiliation': 'Department of Pediatrics, Gynecology and Obstetrics, Faculty of Medicine, University of Geneva, 4 rue Gabrielle-Perret-Gentil, 1211, Genève 14, Switzerland.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ruchonnet-Metrailler', 'Affiliation': 'Department of Pediatrics, Gynecology and Obstetrics, Faculty of Medicine, University of Geneva, 4 rue Gabrielle-Perret-Gentil, 1211, Genève 14, Switzerland.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Avila', 'Affiliation': 'Department of Pediatrics, Gynecology and Obstetrics, Faculty of Medicine, University of Geneva, 4 rue Gabrielle-Perret-Gentil, 1211, Genève 14, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Schittny', 'Affiliation': 'Institute of Anatomy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christian Matthias', 'Initials': 'CM', 'LastName': 'Schlepütz', 'Affiliation': 'Swiss Light Source, Paul Scherrer Institute (PSI), 5232, Villigen, Switzerland.'}, {'ForeName': 'Johannes Constantin', 'Initials': 'JC', 'LastName': 'Schittny', 'Affiliation': 'Institute of Anatomy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Barazzone-Argiroffo', 'Affiliation': 'Department of Pediatrics, Gynecology and Obstetrics, Faculty of Medicine, University of Geneva, 4 rue Gabrielle-Perret-Gentil, 1211, Genève 14, Switzerland. Constance.Barazzone@hcuge.ch.'}]",Respiratory research,['10.1186/s12931-022-01956-4']
3327,35241076,Implementing the WHO Safe Childbirth Checklist modified for preterm birth: lessons learned and experiences from Kenya and Uganda.,"BACKGROUND


The WHO Safe Childbirth Checklist (SCC) contains 29 evidence-based practices (EBPs) across four pause points spanning admission to discharge. It has been shown to increase EBP uptake and has been tailored to specific contexts. However, little research has been conducted in East Africa on use of the SCC to improve intrapartum care, particularly for preterm birth despite its burden. We describe checklist adaptation, user acceptability, implementation and lessons learned.
METHODS


The East Africa Preterm Birth Initiative (PTBi EA) modified the SCC for use in 23 facilities in Western Kenya and Eastern Uganda as part of a cluster randomized controlled trial evaluating a package of facility-based interventions to improve preterm birth outcomes. The modified SCC (mSCC) for prematurity included: addition of a triage pause point before admission; focus on gestational age assessment, identification and management of preterm labour; and alignment with national guidelines. Following introduction, implementation lasted 24 and 34 months in Uganda and Kenya respectively and was supported through complementary mentoring and data strengthening at all sites. PRONTO® simulation training and quality improvement (QI) activities further supported mSCC use at intervention facilities only. A mixed methods approach, including checklist monitoring, provider surveys and in-depth interviews, was used in this analysis.
RESULTS


A total of 19,443 and 2229 checklists were assessed in Kenya and Uganda, respectively. In both countries, triage and admission pause points had the highest rates of completion. Kenya's completion was greater than 70% for all pause points; Uganda ranged from 39 to 75%. Intervention facilities exposed to PRONTO and QI had higher completion rates than control sites. Provider perceptions cited clinical utility of the checklist, particularly when integrated into patient charts. However, some felt it repeated information in other documentation tools. Completion was hindered by workload and staffing issues.
CONCLUSION


This study highlights the feasibility and importance of adaptation, iterative modification and complementary activities to reinforce SCC use. There are important opportunities to improve its clinical utility by the addition of prompts specific to the needs of different contexts. The trial assessing the PTBi EA intervention package was registered at ClinicalTrials.gov NCT03112018 Registered December 2016, retrospectively registered.",2022,Intervention facilities exposed to PRONTO and QI had higher completion rates than control sites.,['23 facilities in Western Kenya and Eastern Uganda'],['modified SCC (mSCC'],"['quality improvement (QI) activities', ""Kenya's completion"", 'EBP uptake']","[{'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.232531,Intervention facilities exposed to PRONTO and QI had higher completion rates than control sites.,"[{'ForeName': 'Kevin Abidha', 'Initials': 'KA', 'LastName': 'Achola', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Darious', 'Initials': 'D', 'LastName': 'Kajjo', 'Affiliation': 'Makerere University School of Public Health, Kampala, Uganda.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Santos', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, San Francisco, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Butrick', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, San Francisco, USA. elizabeth.butrick@ucsf.edu.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Otare', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mubiri', 'Affiliation': 'Makerere University School of Public Health, Kampala, Uganda.'}, {'ForeName': 'Gertrude', 'Initials': 'G', 'LastName': 'Namazzi', 'Affiliation': 'Makerere University School of Public Health, Kampala, Uganda.'}, {'ForeName': 'Rikita', 'Initials': 'R', 'LastName': 'Merai', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, San Francisco, USA.'}, {'ForeName': 'Phelgona', 'Initials': 'P', 'LastName': 'Otieno', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Waiswa', 'Affiliation': 'Makerere University School of Public Health, Kampala, Uganda.'}, {'ForeName': 'Dilys', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, San Francisco, USA.'}]",BMC health services research,['10.1186/s12913-022-07650-x']
3328,35241051,Salivary fluoride concentration following toothbrushing with and without rinsing: a randomised controlled trial.,"BACKGROUND


Caries prevalence has declined significantly since the introduction of fluoridated toothpaste. There have been several developments regarding specific active fluoride ingredients but not enough evidence to support one over the other. The purpose of this double-blind randomized controlled trial was to compare salivary fluoride concentrations of different fluoride formulations in the form of toothpaste with and without post-brushing water rinsing in adults.
METHODS


The study included 120 participants who were randomly assigned to one of 12 groups (10 participants/group). The toothpaste formulas investigated included (1) fluoride-free (0 ppmF); (2) sodium fluoride (1450 ppmF); (3) sodium monofluorophosphate (1450 ppmF); (4) sodium fluoride and monofluorophosphate combined (1450 ppmF); (5) stannous fluoride and sodium fluoride combined (1450 ppmF); and (6) amine fluoride (1400 ppmF). Block randomisation was used to assign each participant to one of the 12 groups. Participants brushed with 1.0 g of one of the six different toothpaste formulations either with or without post-brushing water rinsing. Saliva was collected at six different times (baseline and at 1, 15, 30, 60, and 90 min/s post-brushing). Samples were analysed using a fluoride ion-specific sensitive electrode connected to an ion analyser.
RESULTS


The demographic characteristics of the participants were not significantly different among the groups (P > 0.05). Time, toothpaste formulation, and post-brushing rinsing routines had significant effects on saliva fluoride retention (P < 0.05). Amine fluoride-containing toothpaste was the only formula that showed statistically significantly higher concentrations of salivary fluoride at 90 min in both the rinsing and non-rinsing groups. Sodium monofluorophosphate toothpaste did not result in a significant difference compared to the control group at any time point, in both rinsing and non-rinsing groups.
CONCLUSIONS


Based on the results from this study, no rinsing after toothbrushing in adults can be recommended when sodium monofluorophosphate containing toothpaste formula is used. It also concludes that amine fluoride resulted in a significantly higher saliva fluoride concentration at 90 min in both the rinsing and non-rinsing groups compared to other fluoride toothpaste formulations. Registry: Protocol Registration and Results System (ClinicalTrials.gov).
CLINICAL TRIAL REGISTRATION NUMBER


NCT02740803 (15/04/2016).",2022,"Sodium monofluorophosphate toothpaste did not result in a significant difference compared to the control group at any time point, in both rinsing and non-rinsing groups.
","['Registry', 'adults', '120 participants who were randomly assigned to one of 12 groups (10 participants/group']","['sodium monofluorophosphate', 'sodium fluoride (1450\xa0ppmF', 'Amine fluoride-containing toothpaste', 'sodium monofluorophosphate (1450\xa0ppmF); (4) sodium fluoride and monofluorophosphate combined (1450\xa0ppmF); (5) stannous fluoride and sodium fluoride combined (1450\xa0ppmF); and (6) amine fluoride', 'fluoridated toothpaste', 'Sodium monofluorophosphate toothpaste', 'amine fluoride', 'fluoride-free (0\xa0ppmF', 'toothbrushing with and without rinsing']","['saliva fluoride concentration', 'concentrations of salivary fluoride', 'Salivary fluoride concentration', 'salivary fluoride concentrations', 'saliva fluoride retention']","[{'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0142890', 'cui_str': 'sodium monofluorophosphate'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0002508', 'cui_str': 'Amine'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0128922', 'cui_str': 'monofluorophosphate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}]","[{'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",120.0,0.123255,"Sodium monofluorophosphate toothpaste did not result in a significant difference compared to the control group at any time point, in both rinsing and non-rinsing groups.
","[{'ForeName': 'Marwah M', 'Initials': 'MM', 'LastName': 'Albahrani', 'Affiliation': 'Department of Paediatric Dentistry, Farwanyia Speciality Dental Centre, Farwanyia, Kuwait.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Alyahya', 'Affiliation': 'Department of Developmental and Preventive Sciences, Kuwait University, Jabriyah, Kuwait.'}, {'ForeName': 'Muawia A', 'Initials': 'MA', 'LastName': 'Qudeimat', 'Affiliation': 'Department of Developmental and Preventive Sciences, Kuwait University, Jabriyah, Kuwait. muawia.qudeimat@ku.edu.kw.'}, {'ForeName': 'K Jack', 'Initials': 'KJ', 'LastName': 'Toumba', 'Affiliation': 'Department of Developmental and Preventive Sciences, Kuwait University, Jabriyah, Kuwait.'}]",BMC oral health,['10.1186/s12903-022-02086-5']
3329,35240925,"Public engagement during a typhoid conjugate vaccine trial in Lalitpur, Nepal- experience, challenges and lessons learnt.","Typhoid is a public health problem in Nepal. To generate evidence on the impact of Typhoid Conjugate Vaccine (TCV), a phase 3, double-blind, randomized controlled trial was conducted in Lalitpur, Nepal. 20,000 children aged between 9 months and ≤16 years were vaccinated with a new TCV, or control vaccine. Participants were actively followed for safety and efficacy over 2 years through passive surveillance (PS) clinics. Several challenges were encountered during vaccination and PS stemming from misinformation, misconception, and fear around clinical trials in the community. Public engagement (PE) activities were conducted across various tiers moving from decision makers in the first tier; to elected local representatives in the second tier; ending with interaction in community with parents/guardians of the targeted population. Prior and during vaccination, engagement was conducted to inform about the study and discuss the importance of vaccination. Post-vaccination, engagement was conducted to inform about PS clinics, alleviate study concerns and share study updates. Direct and continuous interaction with community stakeholders, including parents/guardians of the targeted population contributed to build trust around the study and community willingness to be involved. It helped to raise awareness, drive away misconceptions, and allowed adaptation according to feedback from community members.",2022,"20,000 children aged between 9 months and ≤16 years were vaccinated with a new TCV, or control vaccine.","['20,000 children aged between 9\u2009months and ≤16\u2009years were vaccinated with a']","['new TCV, or control vaccine', 'Typhoid Conjugate Vaccine (TCV']","['safety and efficacy', 'Public engagement (PE) activities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041466', 'cui_str': 'Typhoid fever'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",20000.0,0.391341,"20,000 children aged between 9 months and ≤16 years were vaccinated with a new TCV, or control vaccine.","[{'ForeName': 'Ashata', 'Initials': 'A', 'LastName': 'Dahal', 'Affiliation': 'Patan Academy of Health Sciences, Oxford University Clinical Research Unit-Nepal, Lalitpur, Nepal.'}, {'ForeName': 'Mila', 'Initials': 'M', 'LastName': 'Shakya', 'Affiliation': 'Patan Academy of Health Sciences, Oxford University Clinical Research Unit-Nepal, Lalitpur, Nepal.'}, {'ForeName': 'Dikshya', 'Initials': 'D', 'LastName': 'Pant', 'Affiliation': 'Department of Paediatrics, Patan Academy of Health Sciences, Lalitpur, Nepal.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Adhikari', 'Affiliation': 'Nepal Family Development Foundation, Lalitpur, Nepal.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Colin-Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Theiss-Nyland', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Buddha', 'Initials': 'B', 'LastName': 'Basnyat', 'Affiliation': 'Patan Academy of Health Sciences, Oxford University Clinical Research Unit-Nepal, Lalitpur, Nepal.'}, {'ForeName': 'Shrijana', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Department of Paediatrics, Patan Academy of Health Sciences, Lalitpur, Nepal.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2022.2043104']
3330,35240861,"Association of Intravenous Alteplase, Early Reperfusion, and Clinical Outcome in Patients With Large Vessel Occlusion Stroke: Post Hoc Analysis of the Randomized DIRECT-MT Trial.","BACKGROUND


The added value of intravenous alteplase in reperfusing ischemic brain tissue in patients undergoing endovascular treatment and directly presented to an endovascular treatment-capable hospital is uncertain. We conducted this post hoc analysis of a randomized trial (DIRECT-MT [Direct Intraarterial Thrombectomy in Order to Revascularize Acute Ischemic Stroke Patients With Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals: A Multicenter Randomized Clinical Trial]) to explore the association of intravenous alteplase, early (preendovascular treatment) reperfusion, and clinical outcome and to determine factors which may modify alteplase treatment effect on early reperfusion.
METHODS


In this post hoc analysis of the DIRECT-MT randomized trial comparing intravenous alteplase before endovascular treatment versus endovascular treatment only, 623 of 656 randomized patients, with adequate angiographic evaluation for early reperfusion assessment, were included. The association of intravenous alteplase and early reperfusion (defined as expanded Thrombolysis in Cerebral Infarction score ≥2a on angiogram) was assessed using unadjusted comparisons and multivariable logistic regression.
RESULTS


Among 623 patients included (317 received intravenous alteplase and 306 did not), early reperfusion occurred in 91 (15%) patients and was associated with better functional outcome (modified Rankin Scale score, 0-2 of 49/91 [54%] versus 178/531 [34%]; adjusted odds ratio, 1.92 [95% CI, 1.15-3.21];  P <0.001). Intravenous alteplase was independently associated with early reperfusion (59/317 [19%] versus 32/306 [10%]; adjusted odds ratio, 2.06 [95% CI, 1.27-3.33];  P =0.003), and the alteplase effect was modified by time from randomization to groin puncture (dichotomized by median, ≤33 minutes; adjusted odds ratio, 1.06 [95% CI, 0.53-2.10] versus >33 minutes; adjusted odds ratio, 4.07 [95% CI, 1.86-8.86];  P interaction =0.012).
CONCLUSIONS


For patients with large vessel occlusion directly presenting to an endovascular treatment-capable hospital, intravenous alteplase increases early reperfusion when endovascular treatment gets delayed more than approximately half an hour. Thus, intravenous alteplase should be considered if endovascular treatment delays are anticipated by the treating medical team. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03469206.",2022,"Intravenous alteplase was independently associated with early reperfusion (59/317 [19%] versus 32/306 [10%]; adjusted odds ratio, 2.06 [95% CI, 1.27-3.33];  P =0.003), and the alteplase effect was modified by time from randomization to groin puncture (dichotomized by median, ≤33 minutes; adjusted odds ratio, 1.06 [95% CI, 0.53-2.10] versus >33 minutes; adjusted odds ratio, 4.07 [95% CI, 1.86-8.86];  P interaction =0.012).
","['Patients', 'Revascularize Acute Ischemic Stroke Patients With Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals', '623 patients included (317 received', 'patients undergoing endovascular treatment', 'patients with large vessel occlusion directly presenting to an endovascular treatment-capable hospital, intravenous', '623 of 656 randomized patients, with adequate angiographic evaluation for early reperfusion assessment, were included']","['intravenous alteplase', 'alteplase', 'MT [Direct Intraarterial Thrombectomy', 'intravenous alteplase, early (preendovascular treatment) reperfusion']","['functional outcome (modified Rankin Scale score', 'alteplase effect', 'early reperfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0694634', 'cui_str': 'Intra-arterial'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]",656.0,0.162664,"Intravenous alteplase was independently associated with early reperfusion (59/317 [19%] versus 32/306 [10%]; adjusted odds ratio, 2.06 [95% CI, 1.27-3.33];  P =0.003), and the alteplase effect was modified by time from randomization to groin puncture (dichotomized by median, ≤33 minutes; adjusted odds ratio, 1.06 [95% CI, 0.53-2.10] versus >33 minutes; adjusted odds ratio, 4.07 [95% CI, 1.86-8.86];  P interaction =0.012).
","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, L.Z., P.X., Z.L., X.Z., Yongxin Zhang, Yongwei Zhang, B.H., Y.X., Q.H., Q.L., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, L.Z., P.X., Z.L., X.Z., Yongxin Zhang, Yongwei Zhang, B.H., Y.X., Q.H., Q.L., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Ospel', 'Affiliation': 'Department of Radiology, University Hospital Basel, Switzerland (J.O.).'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Department of Clinical Neurosciences and Diagnostic Imaging, University of Calgary Cumming School of Medicine, Canada (M.G., R.M.).'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'McDonough', 'Affiliation': 'Department of Clinical Neurosciences and Diagnostic Imaging, University of Calgary Cumming School of Medicine, Canada (M.G., R.M.).'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Xing', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, L.Z., P.X., Z.L., X.Z., Yongxin Zhang, Yongwei Zhang, B.H., Y.X., Q.H., Q.L., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Zifu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, L.Z., P.X., Z.L., X.Z., Yongxin Zhang, Yongwei Zhang, B.H., Y.X., Q.H., Q.L., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, L.Z., P.X., Z.L., X.Z., Yongxin Zhang, Yongwei Zhang, B.H., Y.X., Q.H., Q.L., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Yongxin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, L.Z., P.X., Z.L., X.Z., Yongxin Zhang, Yongwei Zhang, B.H., Y.X., Q.H., Q.L., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Yongwei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, L.Z., P.X., Z.L., X.Z., Yongxin Zhang, Yongwei Zhang, B.H., Y.X., Q.H., Q.L., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Hong', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, L.Z., P.X., Z.L., X.Z., Yongxin Zhang, Yongwei Zhang, B.H., Y.X., Q.H., Q.L., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, L.Z., P.X., Z.L., X.Z., Yongxin Zhang, Yongwei Zhang, B.H., Y.X., Q.H., Q.L., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Qinghai', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, L.Z., P.X., Z.L., X.Z., Yongxin Zhang, Yongwei Zhang, B.H., Y.X., Q.H., Q.L., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, L.Z., P.X., Z.L., X.Z., Yongxin Zhang, Yongwei Zhang, B.H., Y.X., Q.H., Q.L., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, L.Z., P.X., Z.L., X.Z., Yongxin Zhang, Yongwei Zhang, B.H., Y.X., Q.H., Q.L., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Zuo', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, L.Z., P.X., Z.L., X.Z., Yongxin Zhang, Yongwei Zhang, B.H., Y.X., Q.H., Q.L., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Health Statistics Department, Naval Medical University, Shanghai, China (X.Y.).'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, L.Z., P.X., Z.L., X.Z., Yongxin Zhang, Yongwei Zhang, B.H., Y.X., Q.H., Q.L., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Neurovascular Center, Naval Medical University Changhai Hospital, Shanghai, China (Y. Zhou, L.Z., P.X., Z.L., X.Z., Yongxin Zhang, Yongwei Zhang, B.H., Y.X., Q.H., Q.L., Y.Y., Q.Z., P.Y., J.L.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.121.037061']
3331,35241133,Effect of first dorsal interosseous strengthening on clinical outcomes in patients with thumb osteoarthritis: a study protocol for a randomized controlled clinical trial.,"BACKGROUND


Thumb carpometacarpal osteoarthritis (CMC OA) is characterized by chronic progressive degeneration of the joint cartilage, with high prevalence. Patients present with pain at the base of the thumb, morning stiffness, and muscle weakness, symptoms that affect hand function and therefore interfere in activities and social participation. Movements that involve grip or lateral pinch are the most affected and directly impact independence, self-care, and leisure activities. In the literature consulted, several protocols with exercises for these patients were found. However, most do not compare the same intervention modality and only provide basic methodological information, with no consistent information on training load and load progression. In addition, most protocols only address the strengthening of the abductor and extensor thumb muscles and pinching or grasping exercises. However, some biomechanical and electromyographic studies have demonstrated the important role of the first dorsal interosseous muscles as stabilizers of the thumb carpometacarpal joint.
METHODS


This is a randomized, controlled, double-blind, and parallel clinical trial that will include 56 participants, over 40 years old, with radiographic evidence of thumb base osteoarthritis. Participants will be randomly allocated into two groups: control and intervention. The following evaluations will be conducted: the Australian/Canadian Hand Osteoarthritis Index, Canadian Occupational Performance Measure, Nine-Hole Peg Test, grip and pinch strength associated with muscle activation assessment, and Bilateral Upper Limb Function Test at four different times: baseline, session 13, session 18, and follow-up. Treatment will take place over 6 weeks, with reassessments in the fourth and sixth weeks and 3 months after the end of the intervention (follow-up). Qualitative variables will be expressed as frequency and percentage, and quantitative variables as mean and standard deviation. Intergroup comparison of the intervention will be performed by repeated measures ANOVA, considering the effect of the two groups and four assessments, and interactions between them.
DISCUSSION


This study will demonstrate whether the specific strengthening of the first dorsal interosseous muscle has a superior and positive effect on the clinical picture of patients with CMC OA. Additionally, if specific strengthening of the muscle is not superior to the traditional protocol in the literature, it will also be determined whether the two protocols are equivalent in terms of the best clinical picture.
TRIAL REGISTRATION


Brazilian Registry of Clinical Trials (ReBEC) RBR-8kgqk4 . Prospectively registered on 15 January 2020.",2022,"Movements that involve grip or lateral pinch are the most affected and directly impact independence, self-care, and leisure activities.","['Prospectively registered on 15 January 2020', 'patients with CMC OA', '56 participants, over 40\u2009years old, with radiographic evidence of thumb base osteoarthritis', 'patients with thumb osteoarthritis']",['dorsal interosseous strengthening'],"['activities and social participation', 'clinical outcomes']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0409935', 'cui_str': 'Thumb osteoarthritis NOS'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",56.0,0.11774,"Movements that involve grip or lateral pinch are the most affected and directly impact independence, self-care, and leisure activities.","[{'ForeName': 'Natália Barbosa', 'Initials': 'NB', 'LastName': 'Tossini', 'Affiliation': 'Physical Therapy Department, Federal University of Sao Carlos (UFSCar), Rodovia Washington Luis Km 235, São Carlos, São Paulo, CEP 13565-905, Brazil.'}, {'ForeName': 'Natália Duarte', 'Initials': 'ND', 'LastName': 'Pereira', 'Affiliation': 'Physical Therapy Department, Federal University of Sao Carlos (UFSCar), Rodovia Washington Luis Km 235, São Carlos, São Paulo, CEP 13565-905, Brazil.'}, {'ForeName': 'Gabriela Sardeli', 'Initials': 'GS', 'LastName': 'de Oliveira', 'Affiliation': 'Physical Therapy Department, Federal University of Sao Carlos (UFSCar), Rodovia Washington Luis Km 235, São Carlos, São Paulo, CEP 13565-905, Brazil.'}, {'ForeName': 'Paula Regina Mendes', 'Initials': 'PRM', 'LastName': 'da Silva Serrão', 'Affiliation': 'Physical Therapy Department, Federal University of Sao Carlos (UFSCar), Rodovia Washington Luis Km 235, São Carlos, São Paulo, CEP 13565-905, Brazil. paula.serrao@ufscar.br.'}]",Trials,['10.1186/s13063-022-06120-3']
3332,35241130,"Efficacy and safety of long-term transcutaneous electroacupuncture versus sham transcutaneous electroacupuncture for delayed gastric emptying after distal gastrectomy: study protocol for a randomized, patient-assessor blinded, controlled trial.","BACKGROUND


Delayed gastric emptying (DGE) after distal gastrectomy impacts patients' nutritional status and quality of life. The current treatments of DGE seem unsatisfactory or need invasive interventions. It is unknown whether transcutaneous electroacupuncture (TEA) is effective in treating DGE.
METHODS


A total of 90 eligible participants who underwent distal gastrectomy will be randomly allocated to either the TEA group (n = 60) or the sham transcutaneous electroacupuncture (sham-TEA) group (n = 30). Each participant will receive TEA on the bilateral acupoints of Zusanli (ST36) and Neiguan (PC6) for 4 weeks. The primary outcomes will be the residual rates of radioactivity in the stomach by gastric scintigraphy and total response rates. The secondary outcomes will be endoscopic features, autonomic function, nutritional and psychological status, serum examination, and quality of life (QoL). The adverse events will also be reported. The patients will be followed up 1 year after the treatment.
DISCUSSION


The findings of this randomized trial will provide high-quality evidence regarding the efficacy and safety of long-term TEA for treating DGE after distal gastrectomy.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR2000033965. Registered on 20 June 2020.",2022,"The secondary outcomes will be endoscopic features, autonomic function, nutritional and psychological status, serum examination, and quality of life (QoL).","['delayed gastric emptying after distal gastrectomy', '90 eligible participants who underwent distal gastrectomy']","['sham transcutaneous electroacupuncture (sham-TEA', 'transcutaneous electroacupuncture (TEA', 'TEA', 'long-term transcutaneous electroacupuncture versus sham transcutaneous electroacupuncture', 'bilateral acupoints of Zusanli (ST36) and Neiguan (PC6']","['endoscopic features, autonomic function, nutritional and psychological status, serum examination, and quality of life (QoL', 'adverse events', 'residual rates of radioactivity in the stomach by gastric scintigraphy and total response rates', 'Efficacy and safety']","[{'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0135624', 'cui_str': 'PC6 extract'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0034553', 'cui_str': 'Radioactivity'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",90.0,0.250215,"The secondary outcomes will be endoscopic features, autonomic function, nutritional and psychological status, serum examination, and quality of life (QoL).","[{'ForeName': 'Kai-Bo', 'Initials': 'KB', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Zhi-Wei', 'Initials': 'ZW', 'LastName': 'Wu', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Ling-Hua', 'Initials': 'LH', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastrointestinal Surgery, Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, No. 3 East Qing-Chun Road, Hangzhou, 310020, China.'}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Jin', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Guo-Feng', 'Initials': 'GF', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Mu-Xing', 'Initials': 'MX', 'LastName': 'Kang', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Le-Le', 'Initials': 'LL', 'LastName': 'Lin', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Di-Ke', 'Initials': 'DK', 'LastName': 'Shi', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Shang-Yu branch of SAHZU, School of Medicine, No. 517 Shi-Min Road, Shaoxing, 312300, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University (SAHZU), School of Medicine, No.88 Jie-Fang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Zhi-Qing', 'Initials': 'ZQ', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, Shang-Yu branch of SAHZU, School of Medicine, No. 517 Shi-Min Road, Shaoxing, 312300, China. 1599051443@qq.com.'}]",Trials,['10.1186/s13063-022-06108-z']
3333,35241124,Immediate effects of spinal manipulation on painful sensitivity and postural stability in patients with chronic nonspecific low back pain: study protocol for a controlled randomised clinical trial.,"BACKGROUND


Low back pain is one of the main public health concerns. Chronic low back pain (cLBP) reduces functional capacity and affects postural stability. Although health professionals widely use spinal manipulation, its immediate effect on painful sensitivity and postural stability is lacking. This study aims to verify the immediate effects of lumbar spinal manipulation on the pressure pain threshold and postural stability in individuals with cLBP.
METHODS


A two-arm, placebo-controlled clinical trial with parallel groups and examiner-blinded will be conducted with 80 participants with cLBP from an outpatient physical therapy department, randomly allocated at a 1:1 distribution. The experimental group will receive a lumbar spinal manipulation technique, and the placebo group will receive a simulated lumbar spinal manipulation. Both groups will receive one session of treatment and will be evaluated before and immediately after the intervention. The primary outcomes will be the pressure pain threshold and postural stability. Pain intensity and patient's expectation will be assessed as a secondary outcome. The pressure pain threshold will be assessed using a pressure algometer in 6 different anatomical regions. The evaluation of postural stability will be performed in a baropodometry exam by displacing the centre of pressure. The pain intensity will be measured using the Numeric Pain Rating Scale. A Likert scale will be used for the patient's expectation about the treatment. A two-way analysis of variance will compare the effect of the interventions between groups.
DISCUSSION


This study will provide insights regarding the immediate effects of spinal manipulation in patients with cLBP against a simulated spinal manipulation using objective outcomes and considering patients' expectations regarding the treatment.
TRIAL REGISTRATION


Brazilian Registry of Clinical Trials RBR-3ksq2c . Registered on 13 July 2020.",2022,"This study aims to verify the immediate effects of lumbar spinal manipulation on the pressure pain threshold and postural stability in individuals with cLBP.
","['individuals with cLBP', 'patients with cLBP', '80 participants with cLBP from an outpatient physical therapy department, randomly allocated at a 1:1 distribution', 'patients with chronic nonspecific low back pain']","['lumbar spinal manipulation technique, and the placebo group will receive a simulated lumbar spinal manipulation', 'spinal manipulation', 'placebo', 'lumbar spinal manipulation']","['painful sensitivity and postural stability', 'pressure pain threshold and postural stability', 'Pain intensity', 'pressure pain', 'Numeric Pain Rating Scale', 'pain intensity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",80.0,0.194278,"This study aims to verify the immediate effects of lumbar spinal manipulation on the pressure pain threshold and postural stability in individuals with cLBP.
","[{'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Freitas', 'Affiliation': 'Rehabilitation Science Postgraduation Program, Augusto Motta University Centre (UNISUAM), Rio de Janeiro, Brazil.'}, {'ForeName': 'Leticia Amaral', 'Initials': 'LA', 'LastName': 'Corrêa', 'Affiliation': 'Rehabilitation Science Postgraduation Program, Augusto Motta University Centre (UNISUAM), Rio de Janeiro, Brazil.'}, {'ForeName': 'Juliana Valentim', 'Initials': 'JV', 'LastName': 'Bittencourt', 'Affiliation': 'Rehabilitation Science Postgraduation Program, Augusto Motta University Centre (UNISUAM), Rio de Janeiro, Brazil.'}, {'ForeName': 'Karine Marcondes', 'Initials': 'KM', 'LastName': 'Armstrong', 'Affiliation': 'Physiotherapy Department, Midwestern Parana State University (UNICENTRO), Paraná, Brazil.'}, {'ForeName': 'Leandro Alberto Calazans', 'Initials': 'LAC', 'LastName': 'Nogueira', 'Affiliation': 'Rehabilitation Science Postgraduation Program, Augusto Motta University Centre (UNISUAM), Rio de Janeiro, Brazil. leandronogueira@souunisuam.com.br.'}]",Trials,['10.1186/s13063-022-06111-4']
3334,35241119,Adjusted D-dimer cutoff levels to rule out pulmonary embolism in patients hospitalized for COPD exacerbation: results from the SLICE trial.,"BACKGROUND


For patients with suspected pulmonary embolism (PE), age- or clinically-adjusted D-dimer threshold level can be used to define a negative test that safely excludes PE and reduces the use of imaging. However, the utility of this approach in patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbation is undefined.
METHODS


We ran an analysis of the patients hospitalized for COPD exacerbation and randomized to the intervention in the SLICE trial. Using the conventional strategy as the reference, we compared the proportion of patients with a negative D-dimer result, and the negative predictive value and sensitivity of three D-dimer threshold strategies for initial PE or subsequent diagnosis of venous thromboembolism (VTE): the age-adjusted strategy, the Wells-adjusted strategy, and the YEARS-adjusted strategy.
RESULTS


We included 368 patients. Using a conventional threshold, 182 (49.5%) patients had negative D-dimer values, of whom 1 (0.6%) had PE (sensitivity, 94.1%). The use of an age-adjusted threshold increased the number of patients in whom PE could be excluded from 182 to 233 patients (63.3%), and the proportion of false-negative findings increased from 0.5% to 1.7% (sensitivity, 76.5%). With the use of the Wells or YEARS strategies, 64.4% and 71.5% had negative values, and the proportion of false-negative findings was 2.5% (sensitivity, 64.7%) and 2.7% (sensitivity, 58.8%), respectively.
CONCLUSIONS


In patients hospitalized for COPD exacerbation, compared with the conventional strategy, age- or clinically-adjusted strategies of D-dimer interpretation were associated with a larger proportion of patients in whom PE was ruled out with a higher failure rate.
TRIAL REGISTRATION


ClinicalTrials.gov number: NCT02238639 .",2022,"Using a conventional threshold, 182 (49.5%) patients had negative D-dimer values, of whom 1 (0.6%) had PE (sensitivity, 94.1%).","['patients with suspected pulmonary embolism (PE', '368 patients', 'patients hospitalized for COPD exacerbation', 'patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbation']",[],"['proportion of false-negative findings', 'negative D-dimer values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1563135', 'cui_str': 'Suspected pulmonary embolism'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}]",[],"[{'cui': 'C0205558', 'cui_str': 'False negative'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",368.0,0.0993155,"Using a conventional threshold, 182 (49.5%) patients had negative D-dimer values, of whom 1 (0.6%) had PE (sensitivity, 94.1%).","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rodríguez', 'Affiliation': 'Respiratory Department, Hospital Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Colmenar Road, Km. 9,100, 28034, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Jara-Palomares', 'Affiliation': 'Respiratory Department, Virgen del Rocío Hospital and Instituto de Biomedicina, Sevilla, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Tabernero', 'Affiliation': 'Respiratory Department, Hospital Universitario Cruces, Biocruces-Bizkaia, Barakaldo, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Tenes', 'Affiliation': 'Respiratory Department, Hospital Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Colmenar Road, Km. 9,100, 28034, Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'González', 'Affiliation': 'Respiratory Department, Hospital Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Colmenar Road, Km. 9,100, 28034, Madrid, Spain.'}, {'ForeName': 'Winnifer', 'Initials': 'W', 'LastName': 'Briceño', 'Affiliation': 'Respiratory Department, Hospital Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Colmenar Road, Km. 9,100, 28034, Madrid, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Lobo', 'Affiliation': 'CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Morillo', 'Affiliation': 'Respiratory Department, Hospital Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Colmenar Road, Km. 9,100, 28034, Madrid, Spain.'}, {'ForeName': 'Behnood', 'Initials': 'B', 'LastName': 'Bikdeli', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jiménez', 'Affiliation': 'Respiratory Department, Hospital Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Colmenar Road, Km. 9,100, 28034, Madrid, Spain. djimenez.hrc@gmail.com.'}]",Thrombosis journal,['10.1186/s12959-022-00368-0']
3335,35241047,Clinical application of concentrate growth factors combined with bone substitute in Alveolar ridge preservation of anterior teeth.,"OBJECTIVE


To investigate the clinical effect of concentrated growth factors (CGF) combined with deproteinized bovine bone mineral (DBBM) on Alveolar ridge preservation during implantology.
METHODS


A total of 38 patients were selected and randomly divided into 2 groups, with 19 cases in each group. The extraction sockets were filled with DBBM with or without CGF. Visual analogue scale (VAS) pain score was recorded within1 week and Landry wound healing index (LWHI) was recorded at 1, 2 and 3 weeks after operation. CBCT was taken preoperatively and 3 and 6 months postoperatively to measure and compare the changes of vertical height, width and gray value of alveolar bone at extraction site. The changes of alveolar bone contour were observed clinically and compared between the two groups.
RESULTS


The VAS score of CGF group was lower than control group on the 1st and 3rd day after operation (P < 0.05). The LWHI of CGF group was higher than control group 1 week after operation (P < 0.05). The absorption of the labial and palatal plates height and the width in the CGF group was significantly less than the control group at 3 months (P < 0.05). The gray value of alveolar bone in CGF group was significantly higher than control group at 3 months (P < 0.05). There was no significant difference in new bone contour between the two groups (P > 0.05). 94.7% cases in CGF group did not undergo bone grafting, which was significantly higher than control group (78.9%).
CONCLUSIONS


The use of CGF combined with DBBM can help to reduce postoperative pain at the early stage of healing, form sufficient keratinized gingival tissue, effectively maintain the height and width of alveolar bone in the three-dimensional direction and provide good conditions for implant repair in the future.",2022,The LWHI of CGF group was higher than control group 1 week after operation (P < 0.05).,"['38 patients', 'Alveolar ridge preservation of anterior teeth']","['concentrate growth factors combined with bone substitute', 'CBCT', 'CGF', 'concentrated growth factors (CGF) combined with deproteinized bovine bone mineral (DBBM', 'CGF combined with DBBM', 'DBBM with or without CGF']","['VAS score', 'changes of vertical height, width and gray value of alveolar bone at extraction site', 'new bone contour', 'postoperative pain', 'Landry wound healing index (LWHI', 'gray value of alveolar bone', 'alveolar bone contour', 'absorption of the labial and palatal plates height and the width', 'Visual analogue scale (VAS) pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0243003', 'cui_str': 'Bone Substitute'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",38.0,0.017429,The LWHI of CGF group was higher than control group 1 week after operation (P < 0.05).,"[{'ForeName': 'Dilinuer', 'Initials': 'D', 'LastName': 'Keranmu', 'Affiliation': 'Outpatient Department of Oral Surgery, The First Affiliated Hospital of Xinjiang Medical University (Affiliated Stomatological Hospital). Research Institute of Stomatology of Xinjiang Uygur Autonomous Region, No.393, Xinyi Road, Xinshi District, Ürümqi, 830054, Xinjiang, China.'}, {'ForeName': 'Nijiati', 'Initials': 'N', 'LastName': 'Nuermuhanmode', 'Affiliation': 'Outpatient Department of Oral Surgery, The First Affiliated Hospital of Xinjiang Medical University (Affiliated Stomatological Hospital). Research Institute of Stomatology of Xinjiang Uygur Autonomous Region, No.393, Xinyi Road, Xinshi District, Ürümqi, 830054, Xinjiang, China.'}, {'ForeName': 'Ailimaierdan', 'Initials': 'A', 'LastName': 'Ainiwaer', 'Affiliation': 'Outpatient Department of Oral Surgery, The First Affiliated Hospital of Xinjiang Medical University (Affiliated Stomatological Hospital). Research Institute of Stomatology of Xinjiang Uygur Autonomous Region, No.393, Xinyi Road, Xinshi District, Ürümqi, 830054, Xinjiang, China.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Guli', 'Affiliation': 'Outpatient Department of Oral Surgery, The First Affiliated Hospital of Xinjiang Medical University (Affiliated Stomatological Hospital). Research Institute of Stomatology of Xinjiang Uygur Autonomous Region, No.393, Xinyi Road, Xinshi District, Ürümqi, 830054, Xinjiang, China.'}, {'ForeName': 'Dilidaer', 'Initials': 'D', 'LastName': 'Taxifulati', 'Affiliation': 'Outpatient Department of Oral Surgery, The First Affiliated Hospital of Xinjiang Medical University (Affiliated Stomatological Hospital). Research Institute of Stomatology of Xinjiang Uygur Autonomous Region, No.393, Xinyi Road, Xinshi District, Ürümqi, 830054, Xinjiang, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Shan', 'Affiliation': 'Outpatient Department of Oral Surgery, The First Affiliated Hospital of Xinjiang Medical University (Affiliated Stomatological Hospital). Research Institute of Stomatology of Xinjiang Uygur Autonomous Region, No.393, Xinyi Road, Xinshi District, Ürümqi, 830054, Xinjiang, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Outpatient Department of Oral Surgery, The First Affiliated Hospital of Xinjiang Medical University (Affiliated Stomatological Hospital). Research Institute of Stomatology of Xinjiang Uygur Autonomous Region, No.393, Xinyi Road, Xinshi District, Ürümqi, 830054, Xinjiang, China. crystalWL272@126.com.'}]",BMC oral health,['10.1186/s12903-022-02091-8']
3336,35241042,Understanding how social support influences peer-delivered HIV prevention interventions among Ugandan female sex workers: a case study from HIV self-testing.,"BACKGROUND


Female sex workers (FSWs) have tightly connected peer networks and remain at high risk of HIV acquisition. Peer delivery of HIV prevention interventions, such as HIV self-testing (HIVST), is a recommended implementation strategy for increasing intervention uptake and continuation among FSWs. We analyzed qualitative data from a peer-delivered HIVST intervention among FSWs in urban Uganda to understand the ways social support within this peer network can motivate or discourage the uptake of peer-delivered HIVST.
METHODS


Between February and April 2017, we conducted in-depth interviews (IDIs) with FSWs (n = 30) and focus group discussions (FGDs) with FSW peer educators (PEs, n = 5) finishing participation in a four-month randomized implementation trial testing models of peer-delivered HIVST in Kampala. FSW participants were ≥ 18 years old, self-reported exchanging sex for money or goods (past month) and had not recently tested for HIV (past 3 months). FSW PEs either directly distributed HIVST kits to participants or provided coupons exchangeable for HIVST kits from specified healthcare facilities. In the IDIs and FGDs, we asked participants to share their experiences receiving or delivering peer-delivered HIVST, respectively. Using a hybrid deductive and inductive coding approach, we arranged findings along the dimensions of an established social support theory: informational, instrumental, and emotional support.
RESULTS


The median age of participants was 30 years (IQR: 27-33) and PEs was 33 years (IQR: 29-37). We found that social support within FSW peer networks both motivated and discouraged uptake of peer-delivered HIVST. For example, sharing positive HIVST experiences (informational support), directly delivering HIVST kits (instrumental support), and encouraging linkage to care (emotional support) motivated HIVST uptake among FSWs. Conversely, the spread of misinformation (informational support), limited HIVST kit availability fostering mistrust of PEs (instrumental support), and fear of social exclusion following HIV status disclosure (emotional support) discouraged HIVST uptake among FSWs.
CONCLUSIONS


In Uganda, social support (e.g., informational, instrumental, and emotional support) among FSW peers can work in ways that both motivate and discourage peer-delivered intervention uptake. Future FSW peer-delivered HIV prevention interventions should be designed around the dimensions of social support within FSW peer networks to maximize initial and repeat intervention delivery and uptake.",2022,"Peer delivery of HIV prevention interventions, such as HIV self-testing (HIVST), is a recommended implementation strategy for increasing intervention uptake and continuation among FSWs.","['Ugandan female sex workers', 'Female sex workers (FSWs', 'The median age of participants was 30\u2009years (IQR: 27-33) and PEs was 33\u2009years (IQR: 29-37', 'Between February and April 2017', 'FSW participants were ≥ 18\u2009years old, self-reported exchanging sex for money or goods (past month) and had not recently tested for HIV (past 3\u2009months']","['HIVST intervention', 'HIV prevention interventions, such as HIV self-testing (HIVST', 'FSWs (n\xa0=\u200930) and focus group discussions (FGDs) with FSW peer educators (PEs, n\xa0=\u20095) finishing participation', 'social support influences peer-delivered HIV prevention interventions', 'FSW PEs either directly distributed HIVST kits']",[],"[{'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}]",[],,0.103876,"Peer delivery of HIV prevention interventions, such as HIV self-testing (HIVST), is a recommended implementation strategy for increasing intervention uptake and continuation among FSWs.","[{'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'McGowan', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany. maureen.mcgowan@uni-heidelberg.de.'}, {'ForeName': 'Stephanie D', 'Initials': 'SD', 'LastName': 'Roche', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, USA.'}, {'ForeName': 'Aidah', 'Initials': 'A', 'LastName': 'Nakitende', 'Affiliation': 'International Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Wachinger', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Nanyiri', 'Affiliation': 'International Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Amongin', 'Affiliation': 'International Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Ajiri', 'Initials': 'A', 'LastName': 'Nakabuye', 'Affiliation': 'International Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Daniel Kibuuka', 'Initials': 'DK', 'LastName': 'Musoke', 'Affiliation': 'International Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Shannon A', 'Initials': 'SA', 'LastName': 'McMahon', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bӓrnighausen', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.'}, {'ForeName': 'Katrina F', 'Initials': 'KF', 'LastName': 'Ortblad', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, USA.'}]",BMC public health,['10.1186/s12889-022-12836-3']
3337,35241023,Tranexamic acid for reducing blood loss following vaginal delivery: a double-blind randomized controlled trial.,"BACKGROUND


Postpartum haemorrhage (PPH) is a major cause of maternal morbidity and mortality worldwide. Tranexamic acid (TXA) is a useful drug for prevention of PPH and merits evaluation in Nigeria, where PPH is the leading cause of maternal death (25%) and severe maternal morbidity. This study evaluates the efficacy of TXA in reducing blood loss following vaginal delivery.
METHODS


This was a double-blind randomized placebo-controlled study on the efficacy and safety of intravenous TXA in reducing blood loss in women undergoing vaginal delivery in a tertiary hospital. Data analysis was conducted with IBM SPSS software (version 20, Chicago II, USA). P-value < 0.05 was considered statistically significant.
RESULTS


The mean estimated blood loss was lower in TXA compared with the placebo group. (174.87 ± 119.83 ml versus 341.07 ± 67.97 ml respectively; P < 0.0001). PPH (blood loss > 500 ml) was 5.13% in the study arm compared to the control arm 7.14%- risk ratio (RR) 0.71; 95% CI: 0.38-1.79, p = 0.5956]. Additional uterotonics was required more in the control group compared to the treatment group 14(16.67%) versus 3(3.85%), p-value= 0.007. There were no major complications noticed in the treatment group.
CONCLUSION


This study demonstrated that intravenous administration of TXA reduced blood loss following vaginal delivery. It also reduced the need for additional uterotonics. However, blood loss greater than 500 was not significantly reduced.
TRIAL REGISTRATION


This trial was registered retrospectively. Pan African Clinical Trial Registry: PACTR202010828881019 on 12/10/2020.",2022,"Additional uterotonics was required more in the control group compared to the treatment group 14(16.67%) versus 3(3.85%), p-value= 0.007.","['vaginal delivery', 'women undergoing vaginal delivery in a tertiary hospital']","['Tranexamic acid', 'placebo', 'intravenous TXA', 'Tranexamic acid (TXA', 'TXA']","['blood loss', 'PPH (blood loss\u2009', 'severe maternal morbidity', 'mean estimated blood loss', 'efficacy and safety']","[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.5998,"Additional uterotonics was required more in the control group compared to the treatment group 14(16.67%) versus 3(3.85%), p-value= 0.007.","[{'ForeName': 'Francis Nwabueze', 'Initials': 'FN', 'LastName': 'Igboke', 'Affiliation': 'Alex-Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria. igbokefrancisn@gmail.com.'}, {'ForeName': 'Vitus Okwuchukwu', 'Initials': 'VO', 'LastName': 'Obi', 'Affiliation': 'Alex-Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Benedict Ikechukwu', 'Initials': 'BI', 'LastName': 'Dimejesi', 'Affiliation': 'Alex-Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.'}, {'ForeName': 'Lucky Osaheni', 'Initials': 'LO', 'LastName': 'Lawani', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, M5T 3M6, Canada.'}]",BMC pregnancy and childbirth,['10.1186/s12884-022-04462-z']
3338,35241006,The effect of blister packaging Iron and Folate on adherence to medication and hemoglobin levels among pregnant women at National Referral Hospital antenatal clinics in a low to middle income country: a Randomised Controlled Trial (The IFAd Trial).,"INTRODUCTION


Anemia in pregnancy is an important global public health problem. It is estimated that 38% of pregnant women worldwide are anemic. In Africa, literature from observational studies show 20% of maternal deaths are attributed to anemia. In Uganda, 50% of pregnant women have iron deficiency anaemia. The proportion of pregnant women receiving Iron-Folic acid (IFA) supplementation has improved. However, the number of IFA pills consumed is still low. We carried out a randomized controlled trial to determine the effect of dispensing blister and loose packaged IFA pills on adherence measured by count on next return visit and hemoglobin levels among pregnant women at two National Referral Hospitals in Kampala, Uganda.
METHODS


This trial was conducted between April and October 2016. Nine hundred fifty pregnant women at ≤28 weeks were randomized to either the blister (intervention arm) or loose (control arm) packaged IFA. The participants completed the baseline measurements and received 30 pills of IFA at enrolment to swallow one pill per day. We assessed adherence by pill count and measured hemoglobin at four and 8 weeks. The results were presented using both intention-to-treat and per-protocol analysis.
RESULTS


There were 474 participants in the control and 478 in the intervention arms. Adherence to IFA intake was similar in the two groups at 4th week (40.6 and 39.0%, p = 0.624) and 8th week (51.9 and 46.8%, p = 0.119). The mean hemoglobin level at 4 weeks was higher in the blister than in the loose packaging arms (11.9 + 1.1 g/dl and 11.8 + 1.3 g/dl, respectively; p = 0.02), however, similar at week 8 (12.1 + 1.2 and 12.0 + 1.3, respectively; p = 0.23). However, over the 8-week period blister packaging arm had a higher change in hemoglobin level compared to loose package (blister package 0.6 ± 1.0; loose packaging 0.2 ± 1.1; difference: 0.4 g/dL (95% CI: 0.24-0.51 g/dL); p = 0.001. There were no serious adverse events.
CONCLUSIONS


Our results showed no effect of blister packaging on IFA adherence among pregnant women. However, our findings showed that blister packaged group had a higher hemoglobin increase compared to loose iron group.
TRIAL REGISTRATION


No. PACTR201707002436264 (20 /07/ 2017).",2022,"The mean hemoglobin level at 4 weeks was higher in the blister than in the loose packaging arms (11.9 + 1.1 g/dl and 11.8 + 1.3 g/dl, respectively; p = 0.02), however, similar at week 8 (12.1 + 1.2 and 12.0 + 1.3, respectively; p = 0.23).","['pregnant women', 'pregnant women at National Referral Hospital antenatal clinics in a low to middle income country', '474 participants in the control and 478 in the intervention arms', 'Nine hundred fifty pregnant women at ≤28\u2009weeks', 'pregnant women at two National Referral Hospitals in Kampala, Uganda', 'pregnant women receiving']","['30 pills of IFA', 'blister (intervention arm) or loose (control arm) packaged IFA', 'blister packaging Iron and Folate', 'Iron-Folic acid (IFA) supplementation', 'dispensing blister and loose packaged IFA pills']","['mean hemoglobin level', 'adherence to medication and hemoglobin levels', 'Adherence to IFA intake', 'hemoglobin level', 'hemoglobin increase', 'iron deficiency anaemia', 'IFA adherence', 'adherence by pill count and measured hemoglobin']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0357067', 'cui_str': 'Folic acid- and iron-containing product'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0357067', 'cui_str': 'Folic acid- and iron-containing product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0549448', 'cui_str': 'Increased hemoglobin'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",950.0,0.127262,"The mean hemoglobin level at 4 weeks was higher in the blister than in the loose packaging arms (11.9 + 1.1 g/dl and 11.8 + 1.3 g/dl, respectively; p = 0.02), however, similar at week 8 (12.1 + 1.2 and 12.0 + 1.3, respectively; p = 0.23).","[{'ForeName': 'Josaphat', 'Initials': 'J', 'LastName': 'Byamugisha', 'Affiliation': 'Department of Obstetrics and Gynecology, College of Health Sciences Makerere University, P.O Box 7072, Kampala, Uganda. jbyamugisha@gmail.com.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Adero', 'Affiliation': 'JSI Research & Training Institute Inc., Boston, USA.'}, {'ForeName': 'Tusuubira S', 'Initials': 'TS', 'LastName': 'Kiwanuka', 'Affiliation': 'Baylor College of Medicine COE, Kampala, Uganda.'}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Nalwadda', 'Affiliation': 'School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ntuyo', 'Affiliation': 'Directorate of Obstetrics and Gynecology, Mulago National Referral Hospital, Kampala, Uganda.'}, {'ForeName': 'Imelda', 'Initials': 'I', 'LastName': 'Namagembe', 'Affiliation': 'Directorate of Obstetrics and Gynecology, Mulago National Referral Hospital, Kampala, Uganda.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Nabunya', 'Affiliation': 'Directorate of Obstetrics and Gynecology, Mulago National Referral Hospital, Kampala, Uganda.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Nakirijja', 'Affiliation': 'Directorate of Obstetrics and Gynecology, Mulago National Referral Hospital, Kampala, Uganda.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mwadime-Ngolo', 'Affiliation': 'JSI Research & Training Institute Inc., Boston, USA.'}, {'ForeName': 'David Christopher', 'Initials': 'DC', 'LastName': 'Mukasa', 'Affiliation': 'University Hospital, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Ononge', 'Affiliation': 'Department of Obstetrics and Gynecology, College of Health Sciences Makerere University, P.O Box 7072, Kampala, Uganda.'}]",BMC pregnancy and childbirth,['10.1186/s12884-022-04507-3']
3339,35241434,Responsiveness and meaningful change thresholds of the Living with Pulmonary Fibrosis (L-PF) questionnaire Dyspnoea and Cough scores in patients with progressive fibrosing interstitial lung diseases.,"BACKGROUND


The Living with Pulmonary Fibrosis (L-PF) questionnaire assesses symptoms and quality of life in patients with fibrosing interstitial lung diseases (ILDs). Its Dyspnoea and Cough domains, whose items' responses are based on a 24-hour recall, have scores ranging from 0 to 100, with higher scores indicating greater symptom severity. We evaluated the ability of these domain scores to detect change and estimated their meaningful change thresholds in patients with progressive fibrosing ILDs.
METHODS


The INBUILD trial enrolled subjects with progressive fibrosing ILDs other than idiopathic pulmonary fibrosis. The L-PF questionnaire was completed at baseline and week 52. The responsiveness of the Dyspnoea and Cough scores was evaluated by comparing changes in these scores with 52-week changes in three anchors: forced vital capacity % predicted and two self-reported items, one for global physical health and one for global quality of life. We used a triangulation approach including anchor-based and distribution-based methods to estimate meaningful change thresholds.
RESULTS


The analyses included 542 subjects with an L-PF Dyspnoea score at baseline and week 52, and 538 subjects with an L-PF Cough score at baseline and week 52. The L-PF Dyspnoea and Cough scores were responsive to change over 52 weeks. Triangulation of anchor-based and distribution-based estimates resulted in meaningful change thresholds of 6 to 7 points for the L-PF Dyspnoea score and 4 to 5 points for the L-PF Cough score to differentiate subjects who were stable or improved from those who deteriorated.
CONCLUSION


These analyses support the responsiveness, one aspect of validity, of the L-PF Dyspnoea and Cough domains scores as measures of symptom severity in patients with progressive fibrosing ILDs. Estimates for meaningful change thresholds in these domain scores may be of value in interpreting the effects of interventions in these patients.
TRIAL REGISTRATION NUMBER


NCT02999178.",2022,"These analyses support the responsiveness, one aspect of validity, of the L-PF Dyspnoea and Cough domains scores as measures of symptom severity in patients with progressive fibrosing ILDs.","['patients with progressive fibrosing interstitial lung diseases', '542 subjects with an L-PF Dyspnoea score at baseline and week 52, and 538 subjects with an L-PF Cough score at baseline and week 52', 'trial enrolled subjects with progressive fibrosing ILDs other than idiopathic pulmonary fibrosis', 'patients with progressive fibrosing ILDs', 'patients with fibrosing interstitial lung diseases (ILDs']",[],"['responsiveness of the Dyspnoea and Cough scores', 'L-PF questionnaire', 'L-PF Dyspnoea and Cough scores', 'global quality of life', 'Responsiveness and meaningful change thresholds of the Living with Pulmonary Fibrosis (L-PF) questionnaire Dyspnoea and Cough scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}]",[],"[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",542.0,0.0603407,"These analyses support the responsiveness, one aspect of validity, of the L-PF Dyspnoea and Cough domains scores as measures of symptom severity in patients with progressive fibrosing ILDs.","[{'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Swigris', 'Affiliation': 'National Jewish Health, Denver, Colorado, USA swigrisj@njhealth.org.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Bushnell', 'Affiliation': 'Evidera (Pharmaceutical Product Development, LLC), Bethesda, Maryland, USA.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Rohr', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Mueller', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baldwin', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.'}]",BMJ open respiratory research,['10.1136/bmjresp-2021-001167']
3340,35241426,"Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis.","OBJECTIVE


To evaluate the efficacy and safety of an oral selective tyrosine kinase 2 (TYK2) inhibitor, deucravacitinib, in patients with active psoriatic arthritis (PsA).
METHODS


In this double-blind, phase II trial, 203 patients with PsA were randomised 1:1:1 to placebo, deucravacitinib 6 mg once a day or 12 mg once a day. The primary endpoint was American College of Rheumatology-20 (ACR-20) response at week 16.
RESULTS


ACR-20 response was significantly higher with deucravacitinib 6 mg once a day (52.9%, p=0.0134) and 12 mg once a day (62.7%, p = 0.0004) versus placebo (31.8%) at week 16. Both deucravacitinib doses resulted in significant improvements versus placebo (p≤0.05) in the multiplicity-controlled secondary endpoints of change from baseline in Health Assessment Questionnaire-Disability Index and Short Form-36 Physical Component Summary score and in Psoriasis Area and Severity Index-75 response. Improvements were also seen in multiple exploratory endpoints with deucravacitinib treatment. The most common adverse events (AEs) (≥5%) in deucravacitinib-treated patients were nasopharyngitis, upper respiratory tract infection, sinusitis, bronchitis, rash, headache and diarrhoea. There were no serious AEs and no occurrence of herpes zoster, opportunistic infections and major adverse cardiovascular events, or differences versus placebo in mean changes in laboratory parameters with deucravacitinib treatment.
CONCLUSIONS


Treatment with the selective TYK2 inhibitor deucravacitinib was well tolerated and resulted in greater improvements than placebo in ACR-20, multiplicity-controlled secondary endpoints and other exploratory efficacy measures in patients with PsA. Larger trials over longer periods of time with deucravacitinib are warranted to confirm its safety profile and benefits in PsA.
TRIAL REGISTRATION NUMBER


NCT03881059.",2022,"There were no serious AEs and no occurrence of herpes zoster, opportunistic infections and major adverse cardiovascular events, or differences versus placebo in mean changes in laboratory parameters with deucravacitinib treatment.
","['patients with active psoriatic arthritis (PsA', 'psoriatic arthritis', '203 patients with PsA']","['selective TYK2 inhibitor, deucravacitinib', 'placebo, deucravacitinib', 'oral selective tyrosine kinase 2 (TYK2) inhibitor, deucravacitinib', 'placebo']","['Health Assessment Questionnaire-Disability Index and Short Form-36 Physical Component Summary score and in Psoriasis Area and Severity Index-75 response', 'ACR-20 response', 'nasopharyngitis, upper respiratory tract infection, sinusitis, bronchitis, rash, headache and diarrhoea', 'herpes zoster, opportunistic infections and major adverse cardiovascular events', 'efficacy and safety', 'American College of Rheumatology-20 (ACR-20) response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}]","[{'cui': 'C1706299', 'cui_str': 'Tyrosine Kinase 2'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0037199', 'cui_str': 'Sinusitis'}, {'cui': 'C0006277', 'cui_str': 'Bronchitis'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",203.0,0.188023,"There were no serious AEs and no occurrence of herpes zoster, opportunistic infections and major adverse cardiovascular events, or differences versus placebo in mean changes in laboratory parameters with deucravacitinib treatment.
","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, Washington, USA pmease@philipmease.com.'}, {'ForeName': 'Atul A', 'Initials': 'AA', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Behrens', 'Affiliation': 'Rheumatology and Fraunhofer Institute, Translational Medicine and Pharmacology (ITMP) & Fraunhofer Cluster of Excellence Immune-Mediated Diseases (CIMD), Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Kivitz', 'Affiliation': 'Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Neal', 'Affiliation': 'Arthritis Center of Lexington, University of Kentucky School of Medicine, Lexington, Kentucky, USA.'}, {'ForeName': 'Jonghyeon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Shalabh', 'Initials': 'S', 'LastName': 'Singhal', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Miroslawa', 'Initials': 'M', 'LastName': 'Nowak', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Subhashis', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2021-221664']
3341,35241394,Effect of a Smoking and Alcohol Cessation Intervention Initiated Shortly Before Radical Cystectomy-the STOP-OP Study: A Randomised Clinical Trial.,"BACKGROUND


Evidence concerning the reduction of postoperative complications due to smoking and alcohol drinking in patients undergoing radical cystectomy is incomplete.
OBJECTIVE


To evaluate the efficacy of a 6-wk smoking and/or alcohol cessation intervention, initiated shortly before surgery and continued until 4 wk after, in reducing complications.
DESIGN, SETTING, AND PARTICIPANTS


Between 2014 and 2018, we enrolled 104 patients with high-risk bladder cancer who were daily smokers or consuming at least 3 units of alcohol daily in a multicentre randomised clinical trial.
INTERVENTION


Patients were randomised to a 6-wk intensive smoking and/or alcohol cessation intervention or treatment as usual.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was the number of patients developing any postoperative complication, or death, within 30 d after surgery. The secondary endpoints were successful quitters, health-related quality of life, length of stay, time back to habitual activity, and mortality. An intention-to-treat analysis was applied to evaluate treatment effect.
RESULTS AND LIMITATIONS


There were some differences in baseline demographic and lifestyle characteristics. Postoperatively, 64% in the intervention group versus 70% in the control group (risk ratio [RR] 0.91, confidence interval [CI] 0.68-1.21, p = 0.51) developed complications. Significantly fewer patients developed three or more complications after 30 d (RR 0.39; CI 0.18-0.84, p = 0.01). The rates of successful quitting were 51% in the intervention group and 27% in the control group (RR 2, CI 1.14-3.51, p = 0.01). The external validity of this trial may be limited because 53% of eligible patients refused participation.
CONCLUSIONS


Despite a significant effect on the quit rate at completion of the intervention, this multimodal prehabilitation did not show a significant difference regarding our primary outcome postoperative complications.
PATIENT SUMMARY


A 6-wk smoking and alcohol cessation intervention in relation to bladder cancer surgery did not reduce postoperative complications, but it was effective in supporting people to quit in the short term.",2022,"Significantly fewer patients developed three or more complications after 30 d (RR 0.39; CI 0.18-0.84, p = 0.01).","['Between 2014 and 2018', 'Radical Cystectomy-the STOP-OP Study', '104 patients with high-risk bladder cancer who were daily smokers or consuming at least 3 units of alcohol daily in a multicentre randomised clinical trial', 'patients undergoing']","['radical cystectomy', '6-wk intensive smoking and/or alcohol cessation intervention or treatment as usual', 'Smoking and Alcohol Cessation Intervention', 'alcohol cessation intervention', '6-wk smoking and/or alcohol cessation intervention']","['number of patients developing any postoperative complication, or death', 'successful quitters, health-related quality of life, length of stay, time back to habitual activity, and mortality', 'rates of successful quitting', 'postoperative complications', 'quit rate', 'complications']","[{'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",104.0,0.251224,"Significantly fewer patients developed three or more complications after 30 d (RR 0.39; CI 0.18-0.84, p = 0.01).","[{'ForeName': 'Susanne Vahr', 'Initials': 'SV', 'LastName': 'Lauridsen', 'Affiliation': 'Department of Urology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; WHO-CC, Clinical Health Promotion Centre, Parker Institute, Bispebjerg & Frederiksberg Hospital, Copenhagen University Hospitals, Copenhagen, Denmark. Electronic address: Susanne.vahr.lauridsen@regionh.dk.'}, {'ForeName': 'Thordis', 'Initials': 'T', 'LastName': 'Thomsen', 'Affiliation': 'Department of Anaesthesiology, Herlev and Gentofte Hospital, Copenhagen University Hospitals, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jørgen Bjerggaard', 'Initials': 'JB', 'LastName': 'Jensen', 'Affiliation': 'Department of Urology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'Department of Clinical Research, Copenhagen University Hospital Amager and Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Schmidt Behrend', 'Affiliation': 'Department of Urology, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Steffensen', 'Affiliation': 'Department of Urology, Aalborg University Hospital, Farso, Denmark.'}, {'ForeName': 'Alicia Martin', 'Initials': 'AM', 'LastName': 'Poulsen', 'Affiliation': 'Department of Urology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Urology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Department of Urology, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Walther', 'Affiliation': 'Division of Clinical Chemistry and Pharmacology, Department of Laboratory Medicine, University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Isaksson', 'Affiliation': 'Division of Clinical Chemistry and Pharmacology, Department of Laboratory Medicine, University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thind', 'Affiliation': 'Department of Urology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Tønnesen', 'Affiliation': 'WHO-CC, Clinical Health Promotion Centre, Parker Institute, Bispebjerg & Frederiksberg Hospital, Copenhagen University Hospitals, Copenhagen, Denmark; Clinical Health Promotion Centre, Health Sciences, Lund University, Lund, Skåne, Sweden.'}]",European urology focus,['10.1016/j.euf.2022.02.005']
3342,35241386,Three-dimensional image study of accelerated maxillary expansion in oral breathing kids.,"OBJECTIVE


To evaluate, by a three-dimensional study, the volumetric and integumentary effects of rapid maxillary expansion on the nose, in mouth breathing kids with maxillary hypoplasia, in the short term, assessing the possible interference of gender, growth and age on the results achieved.
METHOD


120 mouth breathing patients with maxilla hypoplasia were divided into an Experimental Group treated by rapid maxillary expansion (n = 104, 62 males and 42 females, mean age 10.1 years, SD = 2.10, ranging from 5.1 to 13.9 years); and Control Group, constituted by 16 patients (9 males and 7 females, mean age 9.3 years, SD = 2.1 years, ranging from 6.1 to 13.2 years). Patients in the experimental group underwent multislice computed tomography examinations at two different times: (T1) pre-expansion and (T2) post-expansion. The control group was submitted to the same tests at the same time intervals. Six soft tissue variables of the nose were studied, besides the volume and area of the nasal cavity, and the measurement and comparison of data between T1 and T2 were performed using the Dolphin Imaging 11.7 Premium software.
RESULTS


The experimental group showed significant mean increases in all soft tissue variables studied (p < 0.005), yet there were no significant changes in the control group. In the comparison between groups, only inclination of the nasal dorsum did not present any significant change.
CONCLUSION


Rapid maxillary expansion may alter the nasal shape and physiology, by anatomical changes in the nose soft tissues, making it an important aid in the treatment of mouth breathing in childhood.
LEVEL OF EVIDENCE


The soft tissues of the nose play an important role in nasal shape and physiology and facial esthetics, and since they are directly related to the nasal valves, they are fundamental for maintenance and stability of the nasal breathing pattern.",2022,"The experimental group showed significant mean increases in all soft tissue variables studied (p < 0.005), yet there were no significant changes in the control group.","['mouth breathing kids with maxillary hypoplasia', 'n\u202f=\u202f104, 62 males and 42 females, mean age 10.1 years, SD\u202f=\u202f2.10, ranging from 5.1 to 13.9 years); and Control Group, constituted by 16 patients (9 males and 7 females, mean age 9.3 years, SD\u202f=\u202f2.1 years, ranging from 6.1 to 13.2 years', 'oral breathing kids', '120 mouth breathing patients with maxilla hypoplasia']","['rapid maxillary expansion', 'multislice computed tomography examinations']",['soft tissue variables'],"[{'cui': 'C0026635', 'cui_str': 'Mouth breathing'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0240310', 'cui_str': 'Maxillary hypoplasia'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0243069', 'cui_str': 'Hypoplasia'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}, {'cui': 'C3179130', 'cui_str': 'Multidetector-Row Computed Tomography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",120.0,0.00730656,"The experimental group showed significant mean increases in all soft tissue variables studied (p < 0.005), yet there were no significant changes in the control group.","[{'ForeName': 'Fauze Ramez', 'Initials': 'FR', 'LastName': 'Badreddine', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Departamento de Otorrinolaringologia e Cirurgia de Cabeça e Pescoço, Disciplina de Otorrinolaringologia Pediátrica, São Paulo, SP, Brazil. Electronic address: dr.fauze@hotmail.com.'}, {'ForeName': 'Lucia Hatsue', 'Initials': 'LH', 'LastName': 'Yamamoto', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Departamento de Otorrinolaringologia e Cirurgia de Cabeça e Pescoço, Disciplina de Otorrinolaringologia Pediátrica, São Paulo, SP, Brazil.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Besen', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Departamento de Otorrinolaringologia e Cirurgia de Cabeça e Pescoço, Disciplina de Otorrinolaringologia Pediátrica, Especialista em Ortodontia e Ortopedia Facial, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniela Pimentel Machado Renófio', 'Initials': 'DPMR', 'LastName': 'Hoppe', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Departamento de Otorrinolaringologia e Cirurgia de Cabeça e Pescoço, Disciplina de Otorrinolaringologia Pediátrica, São Paulo, SP, Brazil.'}, {'ForeName': 'Reginaldo Raimundo', 'Initials': 'RR', 'LastName': 'Fujita', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Departamento de Otorrinolaringologia e Cirurgia de Cabeça e Pescoço, Disciplina de Otorrinolaringologia Pediátrica, São Paulo, SP, Brazil.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cappellette Junior', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Departamento de Otorrinolaringologia e Cirurgia de Cabeça e Pescoço, Disciplina de Otorrinolaringologia Pediátrica, São Paulo, SP, Brazil.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2022.01.007']
3343,35246089,Adhesion and whitening efficacy of P11-4 self-assembling peptide and HAP suspension after using NaOCl as a pre-treatment agent.,"BACKGROUND


This study evaluated the adhesion and whitening efficacy of a mixture of hydroxyapatite and P11-4 self-assembling peptide (HAP-peptide) on bovine enamel after pre-treatment with low-concentrated sodium hypochlorite (NaOCl).
METHODS


Fifty-two caries-free bovine incisors were selected. 50 teeth were randomly allocated to five groups (n = 10). The first group was treated with a mixture of 6.25 wt% HAP and 5 ml P11-4 peptide, using NaOCl 3% as pre-treatment. Second, third and fourth groups were treated with 6.25 wt% HAP, 5 ml P11-4 peptide, and NaOCl 3%, respectively. In the fifth group, only water was applied (control group). The color of samples was measured using a spectrophotometer (USB4000-VIS-NIR-ES, Ostfildern, Germany). To evaluate color changes, ΔE values were statistically analyzed. Finally, adherence of HAP particles on two enamel surfaces with and without pre-treatment with NaOCl was analyzed with SEM.
RESULTS


It was observed that the ΔE of the HAP-peptide suspension after pre-treatment with NaOCl was significantly stronger than the control group. In contrast, the overall color changes of separate applications of HAP, peptide, and NaOCl did not differ notably from the control group. SEM observations confirmed that pre-treatment with NaOCl resulted in a more pronounced coverage of HAP on the enamel surface.
CONCLUSIONS


Pre-treatment with a low-concentrated NaOCl enhanced the adherence of the HAP layer on the enamel surface, resulting in a stronger whitening effect.
TRIAL REGISTRATION


The peptide-HAP suspension is effective in improving tooth whiteness.",2022,"CONCLUSIONS


Pre-treatment with a low-concentrated NaOCl enhanced the adherence of the HAP layer on the enamel surface, resulting in a stronger whitening effect.
","['Fifty-two caries-free bovine incisors were selected', 'bovine enamel after pre-treatment with low-concentrated sodium hypochlorite (NaOCl', '50 teeth']","['P11-4 self-assembling peptide and HAP suspension', 'mixture of hydroxyapatite and P11-4 self-assembling peptide (HAP-peptide']","['Adhesion and whitening efficacy', 'coverage of HAP', 'overall color changes of separate applications of HAP, peptide, and NaOCl', 'adherence of HAP particles']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0673066', 'cui_str': 'P11 (CBL)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}]","[{'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0475330', 'cui_str': 'Color change'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",50.0,0.0379738,"CONCLUSIONS


Pre-treatment with a low-concentrated NaOCl enhanced the adherence of the HAP layer on the enamel surface, resulting in a stronger whitening effect.
","[{'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Hojabri', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336, Munich, Germany.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Kunzelmann', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336, Munich, Germany. karl-heinz.kunzelmann@med.uni-muenchen.de.'}]",BMC oral health,['10.1186/s12903-022-02080-x']
3344,35246053,Impact of a personalised care plan for the elderly calling emergency medical services after a fall at home: The RISING-DOM multi-centre randomised controlled trial protocol.,"BACKGROUND


A growing number of emergency calls are made each year for elderly people who fall. Many of them are not taken to hospital or are rapidly discharged from the Emergency Department (ED). Evidence shows that, with no further support, this vulnerable population is particularly at risk of injuries, dependency and death. This study aims to determine the effectiveness of a comprehensive geriatric assessment and a tailored intervention in the elderly calling on an Emergency Medical Service (EMS) for a fall at home, but not conveyed to the ED or rapidly discharged from it (less than 24 h from hospitalisation), to the time to institutionalisation or death.
METHODS


Rising-Dom is a two-arm randomised (ratio 1:1), interventional, multi-centre and open study. Community-dwelling elderly people (≥ 70 years) who call an EMS for a fall at home are recruited. The intervention group receives home visits by a nurse with a comprehensive fall risk assessment and a personalised intervention care plan with a planned follow-up (six nurse home visits and five nurse phone calls). Subjects enrolled in the usual care-control group continue to receive their routine care for the prevention or treatment of diseases. Primary (time to institutionalisation or death) and secondary (unscheduled hospitalisations, additional EMS calls relating to falls, functional decline and quality of life) outcome data will be collected for both groups through five phone calls made by Clinical Research Associates (CRA) blind to the participants' group during the follow-up period (24-months). Twelve hospital centres in the South-West of France are participating in the study as study sites. The inclusion period started in October 2019 and will end in March 2022. By the end of this period, 1,190 subjects are expected to be enrolled.
DISCUSSION


Studies on elderly home falls have rarely concerned people who were not taken to hospital. The Rising-Dom intervention scheme should enhance understanding of features related to this vulnerable population and investigate the impact of a nurse care at home on delaying death and institutionalisation.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT04132544. Registration date: 18/10/2019.
SPONSOR


University Hospital, Toulouse. https://www.clinicaltrials.gov/ct2/show/NCT04132544?term=rising-dom&draw=2&rank=1.",2022,"This study aims to determine the effectiveness of a comprehensive geriatric assessment and a tailored intervention in the elderly calling on an Emergency Medical Service (EMS) for a fall at home, but not conveyed to the ED or rapidly discharged from it (less than 24 h from hospitalisation), to the time to institutionalisation or death.
","['elderly calling emergency medical services after a fall at home', 'Twelve hospital centres in the South-West of France are participating in the study as study sites', 'Community-dwelling elderly people (≥\u200970\xa0years) who call an EMS for a fall at home are recruited', '1,190 subjects are expected to be enrolled', 'elderly calling on an Emergency Medical Service (EMS) for a fall at home, but not conveyed to the ED or rapidly discharged from it (less than 24\xa0h from hospitalisation), to the time to institutionalisation or death', 'elderly people who fall']","['personalised care plan', 'usual care-control group continue to receive their routine care', 'comprehensive geriatric assessment and a tailored intervention', 'home visits by a nurse with a comprehensive fall risk assessment and a personalised intervention care plan with a planned follow-up (six nurse home visits and five nurse phone calls']","['Primary (time to institutionalisation or death) and secondary (unscheduled hospitalisations, additional EMS calls relating to falls, functional decline and quality of life) outcome data']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1532976', 'cui_str': 'Fall risk assessment'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.092446,"This study aims to determine the effectiveness of a comprehensive geriatric assessment and a tailored intervention in the elderly calling on an Emergency Medical Service (EMS) for a fall at home, but not conveyed to the ED or rapidly discharged from it (less than 24 h from hospitalisation), to the time to institutionalisation or death.
","[{'ForeName': 'Wafa', 'Initials': 'W', 'LastName': 'Bouzid', 'Affiliation': 'Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Toulouse, France. bouzid.w@chu-toulouse.fr.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Tavassoli', 'Affiliation': 'Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Berbon', 'Affiliation': 'Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Qassemi', 'Affiliation': 'Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Bounes', 'Affiliation': ""Pôle Médecine d'Urgence, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Azema', 'Affiliation': ""Observatoire Régional Des Urgences d'Occitanie (ORU Occitanie), Hôpital La Grave, Place Lange, 31300, Toulouse, France.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Shourick', 'Affiliation': ""Unité de Soutien Méthodologique À La Recherche (USMR), Service d'Epidémiologie Clinique Et de Santé Publique, CHU de Toulouse, Toulouse, France.""}, {'ForeName': 'Fati', 'Initials': 'F', 'LastName': 'Nourhashémi', 'Affiliation': 'Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}]",BMC geriatrics,['10.1186/s12877-022-02850-w']
3345,35246048,Adjunctive treatment of chronic migraine using an oral dental device: overview and results of a randomized placebo-controlled crossover study.,"OBJECTIVE


To assess the nocioceptive input of habitual nocturnal jaw clenching that acts as a contributing factor in migraine pathogenesis.
BACKGROUND


Habitual nocturnal jaw clenching has been implicated as a trigger, particularly in those whose headaches are present upon waking or shortly thereafter. Nocturnal EMG studies of patients diagnosed with migraine show nearly twice the temporalis clenching EMG levels and double the bite force as matched asymptomatic controls, leading to the speculation that parafunctional clenching activity may have some role in headache pathogenesis. The NTI (Nociceptive Trigeminal Inhibition) oral device is a dental splint designed to reduce nocturnal jaw clenching intensity and is FDA approved for the prevention of medically diagnosed migraine pain based on open label studies. There are no prior placebo-controlled trials to assess the migraine prevention efficacy of the NTI splint. This is the first placebo-controlled cross-over study to assess the efficacy of the NTI splint in patients with Chronic Migraine.
METHOD


A placebo controlled, single-blinded cross-over study was done with IRB oversight assessing the efficacy of the NTI splint compared to placebo using the change in the HIT-6 score as the outcome measure.
RESULTS


68% of refractory chronic migraine sufferers using the NTI as measured by sequential HIT 6 scores had at least a one-category improvement (severe to substantial, or substantial to some, or some to none) compared to 12% when using a placebo device. 36% of subjects using the NTI device reported a two-category improvement in their HIT-6 score, compared to 0% when using placebo.
CONCLUSION


The improvement in HIT-6 scores produced by the NTI device, suggests that patients with Chronic Migraine may have intense nocturnal jaw clenching as a contributing factor to their headache related disability. An NTI device is one method of assessing whether jaw-clenching is a contributing factor to ongoing migraine.
TRIAL REGISTRATION


Current Controlled Trials NCT04871581. 04/05/2021. Retrospectively registered.",2022,"36% of subjects using the NTI device reported a two-category improvement in their HIT-6 score, compared to 0% when using placebo.
","['patients diagnosed with migraine', 'patients with Chronic Migraine']","['NTI splint', 'placebo']","['HIT-6 score', 'HIT-6 scores', 'temporalis clenching EMG levels', 'nocturnal jaw clenching intensity', 'migraine prevention efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}]","[{'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.206709,"36% of subjects using the NTI device reported a two-category improvement in their HIT-6 score, compared to 0% when using placebo.
","[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Blumenfeld', 'Affiliation': 'The Los Angeles and San Diego Headache Centers, Los Angeles, CA, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Boyd', 'Affiliation': 'The Los Angeles and San Diego Headache Centers, Los Angeles, CA, USA. JimBoydDDS@gmail.com.'}]",BMC neurology,['10.1186/s12883-022-02591-8']
3346,35246030,"Effect of intravenous lidocaine on propofol consumption in elderly patients undergoing colonoscopy: a double-blinded, randomized, controlled trial.","BACKGROUND


Elderly patients undergoing colonoscopy with propofol as sedation are prone to respiratory or cardiovascular complications. Intravenous lidocaine has analgesic efficacy and reduces propofol consumption during surgery. Here, the effect of intravenous lidocaine on propofol consumption was evaluated in elderly patients undergoing colonoscopy.
METHODS


Patients were randomly allocated to receive intravenous lidocaine (1.5 mg/kg bolus dose, followed by a 2 mg/kg/h continuous infusion during the procedure; Group L) or a placebo (saline; Group N). During the procedure, sedation was achieved by propofol. The following outcomes were recorded: total propofol consumption; time to loss of consciousness; number of airway modifications; time to the first airway intervention; incidence of sedation-related events; pain score after awakening; endoscopists' and patients' satisfaction scores; memory level of the procedure; and adverse events within 24 h postoperatively.
RESULTS


Compared with Group N, propofol consumption was reduced by 13.2% in Group L (100.30 ± 25.29 mg vs. 115.58 ± 27.52 mg, respectively, p = 0.008). Kaplan-Meier curves showed that the median time to the loss of consciousness episode was shorter in Group L than in Group N (40 s vs. 55 s, respectively, log rank p < 0.0001). The number of airway modifications, time to the first airway intervention, incidence of sedation-related events, time to awakening, pain score after awakening, endoscopists' and patients' satisfaction scores, memory level of the procedure and adverse events within 24 h postoperatively did not differ between the two groups (p > 0.05).
CONCLUSIONS


Intravenous lidocaine can reduce propofol consumption in elderly patients undergoing colonoscopy, with quicker time to loss of consciousness.
TRIAL REGISTRATION


The clinical trial was registered at (12/01/2021, ChiCTR2100042001 ).",2022,"Compared with Group N, propofol consumption was reduced by 13.2% in Group L (100.30 ± 25.29 mg vs. 115.58 ± 27.52 mg, respectively, p = 0.008).","['Patients', 'Elderly patients undergoing colonoscopy with', 'elderly patients undergoing colonoscopy']","['placebo (saline', 'propofol', 'lidocaine', 'intravenous lidocaine']","['analgesic efficacy', ""number of airway modifications, time to the first airway intervention, incidence of sedation-related events, time to awakening, pain score after awakening, endoscopists' and patients' satisfaction scores, memory level of the procedure and adverse events"", ""total propofol consumption; time to loss of consciousness; number of airway modifications; time to the first airway intervention; incidence of sedation-related events; pain score after awakening; endoscopists' and patients' satisfaction scores; memory level of the procedure; and adverse events"", 'median time to the loss of consciousness episode', 'propofol consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0041657', 'cui_str': 'Loss of consciousness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",,0.0959827,"Compared with Group N, propofol consumption was reduced by 13.2% in Group L (100.30 ± 25.29 mg vs. 115.58 ± 27.52 mg, respectively, p = 0.008).","[{'ForeName': 'Meizhen', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Shantou University Medical College, No. 57 Changping Road, Jinping District, Shantou, Guangdong Province, China.'}, {'ForeName': 'Weiqi', 'Initials': 'W', 'LastName': 'Ke', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Shantou University Medical College, No. 57 Changping Road, Jinping District, Shantou, Guangdong Province, China.'}, {'ForeName': 'Shaohui', 'Initials': 'S', 'LastName': 'Zhuang', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Shantou University Medical College, No. 57 Changping Road, Jinping District, Shantou, Guangdong Province, China. doctorzsh@163.com.'}]",BMC anesthesiology,['10.1186/s12871-022-01601-z']
3347,35241476,Ventilation management and outcomes in out-of-hospital cardiac arrest: a protocol for a preplanned secondary analysis of the TTM2 trial.,"INTRODUCTION


Mechanical ventilation is a fundamental component in the management of patients post cardiac arrest. However, the ventilator settings and the gas-exchange targets used after cardiac arrest may not be optimal to minimise post-anoxic secondary brain injury. Therefore, questions remain regarding the best ventilator management in such patients.
METHODS AND ANALYSIS


This is a preplanned analysis of the international randomised controlled trial, targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest (OHCA)-target temperature management 2 (TTM2). The primary objective is to describe ventilatory settings and gas exchange in patients who required invasive mechanical ventilation and included in the TTM2 trial. Secondary objectives include evaluating the association of ventilator settings and gas-exchange values with 6 months mortality and neurological outcome. Adult patients after an OHCA who were included in the TTM2 trial and who received invasive mechanical ventilation will be eligible for this analysis. Data collected in the TTM2 trial that will be analysed include patients' prehospital characteristics, clinical examination, ventilator settings and arterial blood gases recorded at hospital and intensive care unit (ICU) admission and daily during ICU stay.
ETHICS AND DISSEMINATION


The TTM2 study has been approved by the regional ethics committee at Lund University and by all relevant ethics boards in participating countries. No further ethical committee approval is required for this secondary analysis. Data will be disseminated to the scientific community by abstracts and by original articles submitted to peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT02908308.",2022,"This is a preplanned analysis of the international randomised controlled trial, targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest (OHCA)-target temperature management 2 (TTM2).","['patients who required invasive mechanical ventilation and included in the TTM2 trial', 'patients post cardiac arrest', 'Adult patients after an OHCA who were included in the TTM2 trial and who received']","['Mechanical ventilation', 'invasive mechanical ventilation']",['association of ventilator settings and gas-exchange values with 6 months mortality and neurological outcome'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.23815,"This is a preplanned analysis of the international randomised controlled trial, targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest (OHCA)-target temperature management 2 (TTM2).","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Robba', 'Affiliation': 'Department of Anesthesia and Critical Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neuroscience, Genoa, Italy kiarobba@gmail.com.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Department of Clinical Sciences Lund, Anaesthesia and Intensive Care and Clinical Sciences Helsingborg, Helsingborg Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Dankiewicz', 'Affiliation': 'Department of Clinical Sciences Lund, Cardiology, Skåne University Hospital,Lund University, Lund, Lund, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Badenes', 'Affiliation': 'Department of Anesthesiology and Surgical-Trauma Intensive Care, Hospital Clinic Universitari de València, Universitat de València, Valencia, Spain.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Battaglini', 'Affiliation': 'Department of Anesthesia and Critical Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neuroscience, Genoa, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Ball', 'Affiliation': 'Department of Anesthesia and Critical Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neuroscience, Genoa, Italy.'}, {'ForeName': 'Iole', 'Initials': 'I', 'LastName': 'Brunetti', 'Affiliation': 'Department of Anesthesia and Critical Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neuroscience, Genoa, Italy.'}, {'ForeName': 'Wendel-Garcia', 'Initials': 'WG', 'LastName': 'Pedro David', 'Affiliation': 'Institute of Intensive Care Medicine, Zurich, Switzerland, University Hospital of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Department of Intensive Care, Wellington Hospital, Wellington, New Zealand.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Faculty of Health, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Chew', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Janus', 'Initials': 'J', 'LastName': 'Jakobsen', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, UK.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Unden', 'Affiliation': 'Department of Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Department of Anaesthesia, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joannidis', 'Affiliation': 'Division of Intensive Care and Emergency Medicine, Deptartment of Medicine, Medizinische Universität Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Nichol', 'Affiliation': 'Monash University, Melbourne, Victoria, Australia, Melbourne, Ireland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Lundin', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Hollenberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Lilja', 'Affiliation': 'Department of Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Naomi E', 'Initials': 'NE', 'LastName': 'Hammond', 'Affiliation': 'Department of Critical Care, George Institute for Global Health, Newtown, New South Wales, Australia.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Saxena', 'Affiliation': 'St George Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Annborn', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Department of Clinical Medicine, Anaesthesiology and Intensive Care, Lund University, Lund, Sweden.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Solar', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine in Hradec Králové, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Fabio Silvio', 'Initials': 'FS', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care Medicine, Hopital Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Friberg', 'Affiliation': 'Department of of Clinical Sciences Lund, Lund University, Lund, Sweden.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'Department of Anesthesia and Critical Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neuroscience, Genoa, Italy.'}]",BMJ open,['10.1136/bmjopen-2021-058001']
3348,35241474,"Dietary supplements to reduce symptom severity and duration in people with SARS-CoV-2: study protocol for a randomised, double-blind, placebo controlled clinical trial.","INTRODUCTION


COVID-19 has caused morbidity, hospitalisations and deaths worldwide. Despite four approved vaccines for COVID-19 in Canada, there is still a need for effective treatments, especially for people in the community. Vaccine efficacy is not 100% and long-term efficacy is still unknown. Furthermore, there are challenges to herd immunity including vaccine hesitancy and underlying conditions preventing vaccination. We aim to explore if the nutrients vitamin C, vitamin D, vitamin K 2  and zinc are an effective treatment option for outpatients diagnosed with COVID-19. The primary outcome is the difference in participant-reported overall health; secondary outcomes include the effect on health status, symptom severity and duration, frequency and length of hospitalisations and mortality.
METHODS AND ANALYSIS


This study is a two-arm, parallel-group, double-blind, placebo-controlled, phase III randomised controlled trial. 200 patients will be recruited remotely from COVID-19 test centres in Ottawa, Canada associated with The Ottawa Hospital. Overall health will be measured using the EuroQol Visual Assessment Scale; health status will be measured using the EuroQol 5-dimension 5-level questionnaire; symptom severity and duration will be measured using an independently developed questionnaire; analyses will use an area under the curve approach and compare mean scores using unadjusted t tests. Study data will be recorded on electronic case report forms using the Research Electronic Data Capture platform. An independent data safety and monitoring board will perform ongoing review of the study for feasibility and safety.
ETHICS AND DISSEMINATION


This study has received ethical approval from the research ethics boards of the Canadian College of Naturopathic Medicine and the Ottawa Health Sciences Network, as well as regulatory approval from the Therapeutic Products Directorate and Natural and Non-Prescription Health Products Directorate of Health Canada. Results will be published in a peer-reviewed scientific journal with open access.
TRIAL REGISTRATION NUMBER


NCT04780061.",2022,"The primary outcome is the difference in participant-reported overall health; secondary outcomes include the effect on health status, symptom severity and duration, frequency and length of hospitalisations and mortality.
","['outpatients diagnosed with COVID-19', 'people with SARS-CoV-2', '200 patients will be recruited remotely from COVID-19 test centres in Ottawa, Canada associated with The Ottawa Hospital']","['Dietary supplements', 'placebo', 'nutrients vitamin C, vitamin D, vitamin K 2  and zinc']","['Vaccine efficacy', 'EuroQol Visual Assessment Scale; health status', 'health status, symptom severity and duration, frequency and length of hospitalisations and mortality', 'Overall health']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0086605', 'cui_str': 'Vitamin K 2'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",200.0,0.603656,"The primary outcome is the difference in participant-reported overall health; secondary outcomes include the effect on health status, symptom severity and duration, frequency and length of hospitalisations and mortality.
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Legacy', 'Affiliation': 'Research, The Centre for Health Innovation, Ottawa, Ontario, Canada.'}, {'ForeName': 'Dugald', 'Initials': 'D', 'LastName': 'Seely', 'Affiliation': 'Research, The Centre for Health Innovation, Ottawa, Ontario, Canada dseely@thechi.ca.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Conte', 'Affiliation': 'Research, The Centre for Health Innovation, Ottawa, Ontario, Canada.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Psihogios', 'Affiliation': 'Research, The Centre for Health Innovation, Ottawa, Ontario, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ramsay', 'Affiliation': 'Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Salmaan', 'Initials': 'S', 'LastName': 'Kanji', 'Affiliation': 'Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'John-Graydon', 'Initials': 'JG', 'LastName': 'Simmons', 'Affiliation': 'Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kumanan', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2021-057024']
3349,35241469,"Randomised, open-label, multicentric phase III trial to evaluate the safety and efficacy of palbociclib in combination with endocrine therapy, guided by ESR1 mutation monitoring in oestrogen receptor-positive, HER2-negative metastatic breast cancer patients: study design of PADA-1.","INTRODUCTION


The combination of a CDK4/6 inhibitor with an aromatase inhibitor (AI) has recently become the gold standard for AI-sensitive first line treatment of oestrogen receptor-positive (ER+) HER2-negative (HER2-) advanced breast cancer. However, most patients receiving this combination will ultimately progress and require further therapies.Several studies have demonstrated that the onset of a  ESR1  gene mutation lead to AIs resistance in the advanced setting.  ESR1  mutations can be detected in circulating tumour DNA (ctDNA) using a digital PCR assay. Our study aims to prove the clinical efficacy of periodic monitoring for emerging or rise of  ESR1  mutations in ctDNA to trigger an early change from AI plus palbociclib to fulvestrant plus palbociclib treatment while assessing global safety.
METHODS


PADA-1 is a randomised, open-label, multicentric, phase III trial conducted in patients receiving AI and palbociclib as first line therapy for metastatic ER +HER2- breast cancer. 1000 patients will be included and treated with palbociclib in combination with an AI. Patients will be screened for circulating blood  ESR1  mutation detection at regular intervals. Patients for whom a rising circulating  ESR1  mutation is detected without tumour progression (up to N=200) will be randomised (1:1) between (1) Arm A: no modification of therapy; and (2) Arm B: palbociclib in combination with fulvestrant, a selective ER down-regulator. At tumour progression, an optional crossover will be offered to patients randomised in arm A. The coprimary endpoints are (1) Grade ≥3 haematological toxicities and their associations with baseline characteristics and (2) progression-free survival in randomised patients.
ETHICS AND DISSEMINATION


The study has been approved by the French medicines agency (ANSM) and by an ethics committee (ref 01/17_1 CPP Ouest-IV Nantes) in January 2017. The trial results will be published in academic conference presentations and international peer-reviewed journals.
TRIAL REGISTRATION NUMBERS


EudraCT: 2016-004360-18; NCT03079011.",2022,ESR1  ,"['1000 patients will be included and treated with', 'oestrogen receptor-positive, HER2-negative metastatic breast cancer patients', 'patients receiving AI and palbociclib as first line therapy for metastatic ER +HER2- breast cancer']","['palbociclib', 'palbociclib in combination with an AI', 'ESR1', 'EudraCT', 'endocrine therapy, guided by ESR1 mutation monitoring', 'CDK4/6 inhibitor with an aromatase inhibitor (AI']","['safety and efficacy', 'Grade ≥3 haematological toxicities and their associations with baseline characteristics and (2) progression-free survival']","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1000.0,0.219065,ESR1  ,"[{'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Berger', 'Affiliation': 'Biometry Unit, Institut Curie, PSL Research University, Paris and Saint-Cloud, France.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Marce', 'Affiliation': 'Biometry Unit, Data Center, Institut Régional du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Breast Oncology Department, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Anne-Claire', 'Initials': 'AC', 'LastName': 'Hardy-Bessard', 'Affiliation': ""Dapartment of Medical Oncology, Centre Armoricaind'Oncologie, Plérin, France.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Bièche', 'Affiliation': 'Pharmacogenomic Unit, Genetics laboratory, Department of Diagnostic and Theranostic Medicine, Institut Curie and PSL University, Paris, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Pradines', 'Affiliation': 'INSERM U1037 CNRS ERL5294 UPS, Cancer Research Center of Toulouse, Toulouse, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'De La Motte Rouge', 'Affiliation': 'Department of Medical Oncology, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Canon', 'Affiliation': 'Department of Medical Oncology, Grand Hôpital de Charleroi, Charleroi, Belgique.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Arnould', 'Affiliation': 'Department of Pathology, Centre Georges François Leclerc, Dijon, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Clatot', 'Affiliation': 'Department of Medical Oncology, Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Lemonnier', 'Affiliation': 'Research and Development Department, UNICANCER, Paris, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marques', 'Affiliation': 'Research and Development Department, UNICANCER, Paris, France.'}, {'ForeName': 'François-Clement', 'Initials': 'FC', 'LastName': 'Bidard', 'Affiliation': 'Department of Medical Oncology, Institut Curie, UVSQ/Paris Saclay University, Saint Cloud, France francois-clement.bidard@curie.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2021-055821']
3350,35241384,"Simulation-based training in ear, nose and throat skills and emergencies.","OBJECTIVES


The aim of the study was to compare lecture-based teaching and simulation-based hybrid training for ENT induction and objectively assess the performance of trainees in a simulated environment.
METHODS


This is a prospective interventional study that included 60 interns in their rotatory internship with no prior exposure to ENT emergencies. The interns came in batches of 5‒6 for their 15-days ENT postings. On the first day, a pre-test questionnaire, lecture-based teaching on three scenarios and then allocation into one of the three simulation groups- Group A (Tracheostomy group), Group B (Nasogastric tube group), and Group C (Epistaxis group) was done. Hands-on simulation training was given only to the assigned group. At the end of 15-days, post-test questionnaire and an objective assessment of the three scenarios in a simulated environment was conducted. The same training was repeated for each batch of participants who attended the posting.
RESULTS


The participants had significant improvement in the post-test scores in all three scenarios (p <  0.05), and these improvements were marked in those who had received simulated training. On comparing simulation scores, the participants who received hands-on training on a particular scenario outperformed other (p <  0.05).
CONCLUSION


Simulation-based training improves cognition and overall confidence in managing ENT skills and emergencies. In simulation training, objective and standardized assessment is the key to achieve specific learning objectives to improve the psychomotor and cognitive skill.
LEVEL OF EVIDENCE


II.",2022,"The participants had significant improvement in the post-test scores in all three scenarios (p <  0.05), and these improvements were marked in those who had received simulated training.",['included 60 interns in their rotatory internship with no prior exposure to ENT emergencies'],"['Simulation-based training', 'Hands-on simulation training', 'lecture-based teaching and simulation-based hybrid training for ENT induction']","['post-test scores', 'cognition and overall confidence']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0237690', 'cui_str': 'Internship'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0150934', 'cui_str': 'Ear, nose and throat structure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0244708,"The participants had significant improvement in the post-test scores in all three scenarios (p <  0.05), and these improvements were marked in those who had received simulated training.","[{'ForeName': 'Goutham', 'Initials': 'G', 'LastName': 'Mk', 'Affiliation': 'Department of Otorhinolaryngology, Nitte (Deemed to be University), KS Hegde Medical Academy, Mangalore, Karnataka, India.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Saldanha', 'Affiliation': 'Department of Otorhinolaryngology, Nitte (Deemed to be University), KS Hegde Medical Academy, Mangalore, Karnataka, India. Electronic address: saldanhamarina@gmail.com.'}, {'ForeName': 'Vadisha S', 'Initials': 'VS', 'LastName': 'Bhat', 'Affiliation': 'Department of Otorhinolaryngology, Nitte (Deemed to be University), KS Hegde Medical Academy, Mangalore, Karnataka, India.'}, {'ForeName': 'Rajeshwary', 'Initials': 'R', 'LastName': 'A', 'Affiliation': 'Department of Otorhinolaryngology, Nitte (Deemed to be University), KS Hegde Medical Academy, Mangalore, Karnataka, India.'}, {'ForeName': 'Mark Jittu', 'Initials': 'MJ', 'LastName': 'Vincent', 'Affiliation': 'Department of Otorhinolaryngology, Nitte (Deemed to be University), KS Hegde Medical Academy, Mangalore, Karnataka, India.'}, {'ForeName': 'Aishwarya', 'Initials': 'A', 'LastName': 'Ravikumar', 'Affiliation': 'Department of Otorhinolaryngology, Nitte (Deemed to be University), KS Hegde Medical Academy, Mangalore, Karnataka, India.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2022.01.001']
3351,35241369,The Cardioprotective Effect of Vitamin D in Breast Cancer Patients Receiving Adjuvant Doxorubicin Based Chemotherapy.,"PURPOSE


The primary objective of this study was to investigate the potential protective effect of Vitamin D (Vit D) on DOX induced cardio toxicity (DIC) in early breast cancer patients receiving adjuvant DOX based chemotherapy (AC). The secondary objective was to investigate the anti-inflammatory effect of Vit D by measuring serum IL-6 and its correlation with cardio toxicity.
METHODS


This study was carried out on 150 newly diagnosed women with breast cancer who were planned to receive four cycles of adjuvant AC chemotherapy regimen (60 mg/m 2  DOX and 600 mg/m 2  cyclophosphamide) every 21 days. Study patients were randomized 1:1 into a control group treated with AC and a Vit D group treated with AC plus 0.5 µg of Vit D (Bon One 0.5 µg) orally once daily during the whole treatment course. The cardio protective effect of Vit D was assessed by measuring serum levels of Lactate dehydrogenase (LDH), cardiac troponin T (cTnT), and anti-inflammatory Interleukin 6 (IL-6) at baseline, and after 4 cycles of AC in all study patients.
RESULTS


Vit D supplementation in Vit D group patients was associated with a significant decrease (P < 0.001) in serum levels of LDH, cTnT, and IL-6 compared to the control group .
CONCLUSION


The present work provides a promising clinical evidence to support the cardio protective effects of Vit D against DIC through attenuating the evoked pro-inflammatory cytokines induced by DOX.",2022,"RESULTS


Vit D supplementation in Vit D group patients was associated with a significant decrease (P < 0.001) in serum levels of LDH, cTnT, and IL-6 compared to the control group .
","['Breast Cancer Patients Receiving Adjuvant', 'early breast cancer patients receiving adjuvant DOX based chemotherapy (AC', '150 newly diagnosed women with breast cancer who were planned to receive four cycles of']","['adjuvant AC chemotherapy regimen (60 mg/m 2  DOX and 600 mg/m 2  cyclophosphamide', 'Vitamin D', 'Vitamin D (Vit D', 'AC and a Vit D group treated with AC plus 0.5 µg of Vit D', 'Vit D', 'Doxorubicin Based Chemotherapy']","['cardio toxicity (DIC', 'serum levels of Lactate dehydrogenase (LDH), cardiac troponin T (cTnT), and anti-inflammatory Interleukin 6 (IL-6', 'serum levels of LDH, cTnT, and IL-6']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0310589', 'cui_str': 'Vitamin A- and vitamin D-containing product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C3538889', 'cui_str': 'Cardiac troponin T'}]",150.0,0.0684501,"RESULTS


Vit D supplementation in Vit D group patients was associated with a significant decrease (P < 0.001) in serum levels of LDH, cTnT, and IL-6 compared to the control group .
","[{'ForeName': 'Noha A', 'Initials': 'NA', 'LastName': 'El-Bassiouny', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Damanhour University, Egypt. Electronic address: noha.el.bassiouny@pharm.dmu.edu.eg.'}, {'ForeName': 'Maged W', 'Initials': 'MW', 'LastName': 'Helmy', 'Affiliation': 'Department of Pharmacology and toxicology, Faculty of Pharmacy, Damanhour University, Egypt.'}, {'ForeName': 'Mostafa Alaa Eldin', 'Initials': 'MAE', 'LastName': 'Hassan', 'Affiliation': 'Bachelor of Pharmaceutical Sciences, Faculty of Pharmacy, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Gehan A', 'Initials': 'GA', 'LastName': 'Khedr', 'Affiliation': 'Department of Clinical Oncology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}]",Clinical breast cancer,['10.1016/j.clbc.2022.01.008']
3352,35241363,Promoting Healthy Attitudes and Behaviors in Youth Who Experience Homelessness: Results of a Longitudinal Intervention Study.,"PURPOSE


The aim of this study is to determine the effectiveness of a brief intervention to promote responsible substance use and safe sex behaviors in youths experiencing homelessness (YEH).
METHODS


Design: A Solomon four-group (double randomized controlled trial) longitudinal design with repeated measures (3- and 6-month follow-ups) was used in drop-in centers for YEH in Austin, Texas and Columbus, Ohio from which 602 youths, 18-24 years-old (M = 21 ± 1.8), 50% white; 69.9% heterosexual were recruited. A manualized one-on-one intervention consisted of six modules delivered via laptop computers. Modules focused on communication, goal-setting, substance use refusal, safe sex behaviors, enhanced psychological capital (hope, optimism, resilience, self-efficacy, gratitude), and life satisfaction. Valid and reliable measures of hope, optimism, future time perspective, resilience, social connectedness, gratitude, condom intention, self-efficacy for safe sex, safe sex behaviors, self-efficacy for substance use refusal, and life satisfaction were used to collect data for which three hypotheses were tested, using intent to treat, with multi-level modeling (R).
RESULTS


The analysis showed partial support for all hypotheses: (1) post-test outcomes were greater than pretests; (2) intervention group outcomes were greater than control group measures; and (3) significant effects for pretesting. YEH in Ohio completed significantly more sessions than YEH in Texas (p = .001), but took significantly longer to complete all six sessions (p = .001).
DISCUSSION


This brief intervention had significant effects on YEH to promote healthy attitudes and behaviors that merit further testing in larger samples.",2022,"YEH in Ohio completed significantly more sessions than YEH in Texas (p = .001), but took significantly longer to complete all six sessions (p = .001).
","['Design', 'Youth', 'youths experiencing homelessness (YEH', 'drop-in centers for YEH in Austin, Texas and Columbus, Ohio from which 602 youths, 18-24 years-old (M\xa0= 21\xa0±\xa01.8), 50% white; 69.9% heterosexual\xa0were recruited']",['YEH'],"['communication, goal-setting, substance use refusal, safe sex behaviors, enhanced psychological capital (hope, optimism, resilience, self-efficacy, gratitude), and life satisfaction', 'hope, optimism, future time perspective, resilience, social connectedness, gratitude, condom intention, self-efficacy for safe sex, safe sex behaviors, self-efficacy for substance use refusal, and life satisfaction']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0605411', 'cui_str': 'austin'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}]","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0040226', 'cui_str': 'Time Perception'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",602.0,0.0187218,"YEH in Ohio completed significantly more sessions than YEH in Texas (p = .001), but took significantly longer to complete all six sessions (p = .001).
","[{'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rew', 'Affiliation': 'The University of Texas at Austin School of Nursing, Austin, Texas. Electronic address: ellerew@mail.utexas.edu.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Slesnick', 'Affiliation': 'The Ohio State University College of Education and Human Ecology, Columbus, Ohio.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': 'The University of Texas at Austin School of Nursing, Austin, Texas.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sales', 'Affiliation': 'Worcester Polytechnic Institute, Mathematical Sciences, Worcester, Massachusetts.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2021.12.025']
3353,35241351,Characterizing nicotine withdrawal in smokers experiencing homelessness.,"OBJECTIVE


The rate of cigarette smoking among persons experiencing homelessness is five times the national prevalence, and these smokers experience difficulty quitting. Nicotine withdrawal may be a barrier to initiating and sustaining successful smoking cessation, but its time course is poorly characterized in this population. We hypothesize that withdrawal symptoms will be elevated and related to treatment outcomes.
METHODS


This secondary data analysis characterized nicotine withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Severity Index, during a quit attempt in treatment-seeking smokers experiencing homelessness who enrolled in a randomized smoking cessation trial. Participants (N = 70) reported MNWS symptoms three times prior to the scheduled quit date and twice weekly for 4 weeks post-quit date. We also examined the relation of pre-quit symptoms to treatment outcomes (quit day smoking status, patch adherence, duration of abstinence, and percent negative CO samples submitted).
RESULTS


Endorsement of withdrawal symptoms was highest prior to the quit date and decreased over time with increases at weeks 3 to 4; a sizable percentage (20% to 35%) of participants endorsed symptoms throughout the 4 week post-quit period. Severity for most symptoms was at its lowest 2-3 weeks post-quit date, then increased in weeks 3 and 4. Anticipatory withdrawal was inversely related to nicotine patch adherence (p = .01), but not the abstinence-based treatment outcomes (ps > 0.05).
CONCLUSIONS


Continued withdrawal symptom endorsement throughout treatment and increases in severity noted 3 to 4 weeks post-quit date suggest possible targets for intervention as part of smoking cessation counseling for smokers experiencing homelessness. Anticipatory withdrawal symptoms (prior to the quit date) were common and predictive of poor adherence to cessation aids.",2022,"Anticipatory withdrawal was inversely related to nicotine patch adherence (p = .01), but not the abstinence-based treatment outcomes (ps > 0.05).
CONCLUSIONS


Continued withdrawal symptom endorsement throughout treatment and increases in severity noted 3 to 4 weeks post-quit date suggest possible targets for intervention as part of smoking cessation counseling for smokers experiencing homelessness.","['persons experiencing homelessness', 'smokers experiencing homelessness']",['Nicotine'],"['nicotine patch adherence', 'pre-quit symptoms to treatment outcomes (quit day smoking status, patch adherence, duration of abstinence, and percent negative CO samples submitted', 'withdrawal symptoms', 'Anticipatory withdrawal', 'Anticipatory withdrawal symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",,0.0387742,"Anticipatory withdrawal was inversely related to nicotine patch adherence (p = .01), but not the abstinence-based treatment outcomes (ps > 0.05).
CONCLUSIONS


Continued withdrawal symptom endorsement throughout treatment and increases in severity noted 3 to 4 weeks post-quit date suggest possible targets for intervention as part of smoking cessation counseling for smokers experiencing homelessness.","[{'ForeName': 'Gabrielle K', 'Initials': 'GK', 'LastName': 'Sharbin', 'Affiliation': 'University of Connecticut, United States of America.'}, {'ForeName': 'Carla J', 'Initials': 'CJ', 'LastName': 'Rash', 'Affiliation': 'UConn Health School of Medicine, United States of America. Electronic address: Rashc@uchc.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2022.108748']
3354,35241920,"TRC150094, a Novel Mitochondrial Modulator, Reduces Cardio-Metabolic Risk as an Add-On Treatment: a Phase-2, 24-Week, Multi-Center, Randomized, Double-Blind, Clinical Trial.","Background


TRC150094, a novel mitochondrial modulator, reduces insulin resistance and is expected to improve the trinity of dysglycemia, dyslipidemia, and hypertension. In this multi-dose phase-2 study, we evaluated the safety and efficacy of TRC150094 in diabetic subjects with dyslipidemia receiving standard of care.
Methods


A randomized, multicenter, double-blind, placebo-controlled, parallel-group, Phase 2 study was conducted in 225 subjects from July 2013 to August 2015. The key inclusion criteria were body mass index of 23-35 kg/m 2 , age between 30 and 65 years, fasting glucose of ≥126 or glycated hemoglobin (HbA1c) of ≥6.4% stabilized on treatment with ≤2 oral hypoglycemic agents, apolipoprotein-B (apo-B) ≥100 mg/dL, serum triglyceride (TG) ≥150 mg/dL, systolic blood pressure (SBP) ≥130 mmHg, and diastolic blood pressure (DBP) ≥85 mmHg with/without antihypertensive treatment. The subjects were randomly assigned to one of three TRC150094 doses (25, 50, or 75 mg) or placebo for 24 weeks. The outcomes assessed included fasting plasma glucose (FPG), insulin, mean arterial blood pressure (MAP), and apoB. In addition, safety and tolerability were assessed.
Results


A reduction for dose up to 50 mg was noted for FPG in the range of 13.9 to 21.7 mg/dL (p < 0.05 for TRC150094 25 and 50 mg), fasting insulin reduction in the range 2.7 to 6.0 mU/L (all doses, p > 0.05), and improved HOMA-IR (-2.0 to -2.5) (all doses, p > 0.05) compared to placebo after 24 weeks of treatment. Furthermore, a significant reduction in MAP in the range 3.1 to 4.2 mmHg (p < 0.05 for TRC150094 25 and 75 mg) was noted. In addition, TRC150094 treatment was weight neutral, had a favorable effect on lowering atherogenic lipid fractions, including non-HDL cholesterol (-6.8 mg/dL at 50 mg dose). Adverse events were mild to moderate in nature and not dose-related. One adverse event not related to treatment led to the discontinuation of the study. Overall, TRC150094 was safe and well tolerated for up to 24 weeks.
Conclusion


In this study, TRC150094 treatment in the dose range of 25 to 50 mg showed improvement in various components of CMBCD, ie, dysglycemia, dyslipidemia, and hypertension.
Trial Registration


This study was registered in the Clinical Trial Registry of India. Trial registration number: CTRI/2013/03/003444. Date of registration: 4th March 2013.",2022,"Furthermore, a significant reduction in MAP in the range 3.1 to 4.2 mmHg (p < 0.05 for TRC150094 25 and 75 mg) was noted.","['diabetic subjects with dyslipidemia receiving standard of care', '225 subjects from July 2013 to August 2015', 'The key inclusion criteria were body mass index of 23-35 kg/m 2 , age between 30 and 65 years, fasting glucose of ≥126 or glycated hemoglobin (HbA1c) of ≥6.4% stabilized on treatment with ≤2 oral hypoglycemic agents, apolipoprotein-B (apo-B']","['TRC150094', 'placebo']","['FPG', 'MAP', 'fasting insulin reduction', 'safety and efficacy', 'serum triglyceride (TG) ≥150 mg/dL, systolic blood pressure (SBP) ≥130 mmHg, and diastolic blood pressure (DBP', 'fasting plasma glucose (FPG), insulin, mean arterial blood pressure (MAP), and apoB. In addition, safety and tolerability', 'Adverse events', 'safe and well tolerated', 'HOMA-IR', 'lowering atherogenic lipid fractions, including non-HDL cholesterol', 'various components of CMBCD, ie, dysglycemia, dyslipidemia, and hypertension']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}]","[{'cui': 'C3529455', 'cui_str': 'TRC150094'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1960636', 'cui_str': 'Dysglycemia'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",225.0,0.147043,"Furthermore, a significant reduction in MAP in the range 3.1 to 4.2 mmHg (p < 0.05 for TRC150094 25 and 75 mg) was noted.","[{'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Joshi', 'Affiliation': 'Torrent Pharmaceuticals Ltd., Ahmedabad, Gujarat, India.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Gj', 'Affiliation': 'Torrent Pharmaceuticals Ltd., Ahmedabad, Gujarat, India.'}, {'ForeName': 'Shohini', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Torrent Pharmaceuticals Ltd., Ahmedabad, Gujarat, India.'}, {'ForeName': 'Anookh', 'Initials': 'A', 'LastName': 'Mohanan', 'Affiliation': 'Torrent Pharmaceuticals Ltd., Ahmedabad, Gujarat, India.'}, {'ForeName': 'Shashank', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Lilavati Hospital, Mumbai, India.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Mohan', 'Affiliation': ""Dr. Mohan's Diabetes Specialities Centre (Madras Diabetes Research Foundation), Tamil Nadu, India.""}, {'ForeName': 'Subhankar', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Endocrinology, Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital, Kolkata, India.'}, {'ForeName': 'Chaitanya', 'Initials': 'C', 'LastName': 'Dutt', 'Affiliation': 'Torrent Pharmaceuticals Ltd., Ahmedabad, Gujarat, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'Department of Endocrinology, All India Institute of Medical Sciences, New Delhi, India.'}]","Diabetes, metabolic syndrome and obesity : targets and therapy",['10.2147/DMSO.S330515']
3355,35241906,Erratum: Pilot Study of Smartphone Infrared Pupillography and Pupillometry [Erratum].,[This corrects the article DOI: 10.2147/OPTH.S331989.].,2022,[This corrects the article DOI: 10.2147/OPTH.S331989.].,[],['Smartphone Infrared Pupillography and Pupillometry [Erratum'],[],[],"[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}]",[],,0.0746839,[This corrects the article DOI: 10.2147/OPTH.S331989.].,[],"Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S363414']
3356,35241817,Intensive or standard blood pressure control in patients with a history of ischemic stroke: RESPECT post hoc analysis.,"The Recurrent Stroke Prevention Clinical Outcome (RESPECT) Study and its pooled analysis showed that intensive blood pressure (BP) lowering reduced recurrent stroke risk by 22% in patients with a history of stroke. Here, we report the effect of intensive BP lowering on the risk of recurrent stroke subtypes in patients with a history of ischemic stroke. RESPECT was a randomized clinical trial among 1280 people with a history of cerebral infarction or intracerebral hemorrhage. Participants were assigned to the intensive blood pressure control group (blood pressure < 120/80 mmHg) or standard blood pressure control group (blood pressure < 140/90 mmHg). In this post hoc analysis, we analyzed 1074 patients with a history of cerebral infarction. The mean BP at baseline was 140.7/81.4 mmHg. Throughout the follow-up period, the mean BP was 133.4/77.5 (95% CI, 132.7-134.1/76.9-78.2) mmHg in the standard group and 126.7/74.1 (95% CI, 126.0-127.4/73.5-74.8) mmHg in the intensive group. During a mean follow-up of 3.9 years, 78 first recurrent strokes occurred. Intensive treatment tended to reduce overall annual stroke recurrence (1.74% in intensive vs. 2.17% in standard; P = 0.351 by log-rank test) and did not change the risk of ischemic stroke (1.74% vs. 1.75%, P = 0.999) but markedly reduced the risk of hemorrhagic stroke (0.00% vs. 0.39%, P = 0.005). Beneficial effects of intensive BP control were observed for the risk of hemorrhagic stroke in patients with a history of ischemic stroke. The findings of this study indicate the benefit of intensive BP control for patients with a history of ischemic stroke at high risk of hemorrhagic stroke.",2022,Participants were assigned to the intensive blood pressure control group (blood pressure < 120/80 mmHg) or standard blood pressure control group (blood pressure < 140/90 mmHg).,"['patients with a history of ischemic stroke at high risk of hemorrhagic stroke', 'patients with a history of ischemic stroke', '1280 people with a history of cerebral infarction or intracerebral hemorrhage', '1074 patients with a history of cerebral infarction']","['Intensive or standard blood pressure control', 'intensive BP control', 'intensive BP lowering', 'intensive blood pressure control group (blood pressure < 120/80\u2009mmHg) or standard blood pressure control group (blood pressure < 140/90\u2009mmHg']","['risk of ischemic stroke', 'intensive blood pressure (BP) lowering reduced recurrent stroke risk', 'hemorrhagic stroke', 'overall annual stroke recurrence', 'risk of hemorrhagic stroke', 'mean BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5192534', 'cui_str': 'History of cerebrovascular accident due to ischemia'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",1280.0,0.071143,Participants were assigned to the intensive blood pressure control group (blood pressure < 120/80 mmHg) or standard blood pressure control group (blood pressure < 140/90 mmHg).,"[{'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University, Shinjuku, Tokyo, Japan. kitagawa.kazuo@twmu.ac.jp.""}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Department of Prevented Medicine and Public Health, Faculty of Medicine, Fukuoka University, Jonan, Fukuoka, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Stroke Center, Kyoto Katsura Hospital, Nishikyo, Kyoto, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Clinical Pharmacology & Therapeutics, Faculty of Medicine, University of the Ryukyus, Nakagamigunn, Okinawa, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Rakugi', 'Affiliation': 'Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Takahide', 'Initials': 'T', 'LastName': 'Kohro', 'Affiliation': 'Department of Cardiovascular Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Yonemoto', 'Affiliation': 'Division of Biostatistics, School of Health Sciences, Faculty of Medicine, University of the Ryukyus, Nakagamigunn, Okinawa, Japan.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Ikeda City Hospital, Ikeda, Osaka, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Saruta', 'Affiliation': 'Department of Internal Medicine, Keio University School of Medicine, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Shimada', 'Affiliation': 'Cardiovascular Medicine, Shin-Oyama City Hospital, Oyama, Tochigi, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-022-00862-y']
3357,35242370,Clinical assessment of efficacy of poly-L-lactide sternal pin on sternal stability and post-operative pain: a prospective randomized trial in cardiovascular surgery.,"Background


Although the incident rate is low, sternal dislocation and dehiscence due to unstable sternal fixation after cardiovascular surgery could cause potentially lethal complications. Thus, to enforce the stability of closed sternum, the sternal pins have been utilized at surgeon's discretion. However, there is no randomized clinical trial to test whether these pins are effective to stabilize a sternum. Hence, this study aimed to examine the clinical efficacy of bioabsorbable poly-L-lactide (PLLA) sternal pins in reinforcing sternal stability and preventing instability of the sternum after full sternotomy.
Methods


We conducted a single institutional, prospective, randomized, single-blinded clinical study involving 100 patients who underwent an initial cardiovascular surgery via sternotomy. Patients were randomly allocated into two groups: with (group P) and without (group N) PLLA sternal pins, at 1:1 ratio from November 2013 to April 2016. Sternal deviation and stability were assessed with postoperative computed tomography (CT) at two postures to put shear stress on the sternum. Additionally, information on patient demographic indices was obtained prospectively, and patient's pain intensity was assessed with numerical rating scoring system during rehabilitation. Furthermore, propensity score matching was performed for further comparative sub-analysis.
Results


Ninety-one patients (43 in group P and 48 in group N) were analyzed using the intention-to-treat method. Group N had a significantly higher proportion of males (P=0.015) and ischemic disease as a primary diagnosis (P=0.040) than group P. Postoperative CT showed that the degree of sternal deviation and stability were comparable between the groups. Similarly, the numerical rating score of pain during rehabilitation showed no difference between the groups. Even after adjusting for patient characteristics using propensity score matching method, no significant differences in sternal gaps, stability, and numerical rating score of pain were observed. Of note, no material-related adverse event such as wound infection was found.
Conclusions


We could not identify the efficacy of the sternal pin in enforcing sternal stability based on CT measurements with mild shear stress on sternum after cardiovascular surgery. Nevertheless, our results with no adverse events might encourage further investigations with a more specific cohort who is susceptible to infection but requires an additional sternal fixation.
Trial Registration


This study was registered in University Hospital Medical Information Network Clinical Trial Registry (UMIN000017357).",2022,Group N had a significantly higher proportion of males (P=0.015) and ischemic disease as a primary diagnosis (P=0.040) than group P. Postoperative CT showed that the degree of sternal deviation and stability were comparable between the groups.,['100 patients who underwent an initial cardiovascular surgery via sternotomy'],"['bioabsorbable poly-L-lactide (PLLA) sternal pins', 'poly-L-lactide sternal pin', 'PLLA sternal pins']","['sternal deviation and stability', 'sternal gaps, stability, and numerical rating score of pain', 'numerical rating score of pain', 'pain intensity', 'sternal stability and post-operative pain', 'Sternal deviation and stability', 'ischemic disease']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}]","[{'cui': 'C0615693', 'cui_str': 'poly(lactide), (L)-isomer'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}]","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",100.0,0.109763,Group N had a significantly higher proportion of males (P=0.015) and ischemic disease as a primary diagnosis (P=0.040) than group P. Postoperative CT showed that the degree of sternal deviation and stability were comparable between the groups.,"[{'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Takahara', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Konosuke', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Sakuma', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Fujiwara', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Yoshioka', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Kiichiro', 'Initials': 'K', 'LastName': 'Kumagai', 'Affiliation': 'Research Division of Science for Aortic diseases, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Diagnostic Radiology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Takase', 'Affiliation': 'Department of Diagnostic Radiology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yoshikatsu', 'Initials': 'Y', 'LastName': 'Saiki', 'Affiliation': 'Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.'}]",Journal of thoracic disease,['10.21037/jtd-21-1340']
3358,35242730,Biannual Administrations of Azithromycin and the Gastrointestinal Microbiome of Malawian Children: A Nested Cohort Study Within a Randomized Controlled Trial.,"Community-level mass treatment with azithromycin has been associated with a mortality benefit in children. However, antibiotic exposures result in disruption of the gut microbiota and repeated exposures may reduce recovery of the gut flora. We conducted a nested cohort study within the framework of a randomized controlled trial to examine associations between mass drug administration (MDA) with azithromycin and the gut microbiota of rural Malawian children aged between 1 and 59 months. Fecal samples were collected from the children at baseline and 6 months after two or four biannual rounds of azithromycin treatment. DNA was extracted from fecal samples and V4-16S rRNA sequencing used to characterize the gut microbiota.  Firmicutes, Bacteroidetes, Proteobacteria  and  Actinobacteria  were the dominant phyla while  Faecalibacterium  and  Bifidobacterium  were the most prevalent genera. There were no associations between azithromycin treatment and changes in alpha diversity, however, four biannual rounds of treatment were associated with increased abundance of  Prevotella . The lack of significant changes in gut microbiota after four biannual treatments supports the use of mass azithromycin treatment to reduce mortality in children living in low- and middle-income settings.",2022,"There were no associations between azithromycin treatment and changes in alpha diversity, however, four biannual rounds of treatment were associated with increased abundance of  Prevotella .","['children living in low- and middle-income settings', 'Malawian Children', 'children', 'rural Malawian children aged between 1 and 59 months']","['azithromycin', 'Azithromycin']","['Firmicutes, Bacteroidetes, Proteobacteria  and  Actinobacteria', 'alpha diversity', 'abundance of  Prevotella ', 'Fecal samples']","[{'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0751985', 'cui_str': 'Proteobacteria'}, {'cui': 'C0600148', 'cui_str': 'Class Actinobacteria'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0242946', 'cui_str': 'Prevotella'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",,0.170803,"There were no associations between azithromycin treatment and changes in alpha diversity, however, four biannual rounds of treatment were associated with increased abundance of  Prevotella .","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chaima', 'Affiliation': 'Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Pickering', 'Affiliation': 'Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hart', 'Affiliation': 'Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Burr', 'Affiliation': 'Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Houghton', 'Affiliation': 'Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute of Community Outreach, Blantyre, Malawi.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Holland', 'Affiliation': 'Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",Frontiers in public health,['10.3389/fpubh.2022.756318']
3359,35242728,WhatsApp-Delivered Intervention for Continued Learning for Nurses in Pakistan During the COVID-19 Pandemic: Results of a Randomized-Controlled Trial.,"The COVID-19 pandemic has necessitated support for continued learning in frontline practitioners through online digital mediums that are convenient and fast to maintain physical distancing. Nurses are already neglected professionals for support in training for infection control, leadership, and communication in Pakistan and other developing countries. For that reason, we aimed to deliver a WhatsApp-based intervention for continued learning in nurses who are currently working in both private and public sector. A 12-week intervention was delivered to 208 nurses (102 in the control group and 106 in the intervention group) who had been employed in the clinical setting during data collection. The analysis reveals that nurses in the intervention group show significantly better results for learning in ""infection prevention and control"" and ""leadership and communication."" Results of a content analysis based on participant's feedback also confirm that the WhatsApp-based intervention is a valuable tool for education. This study highlights the effectiveness of online-based digital interventions as a convenient training tool for awareness and management of infectious diseases, leadership, and communication during COVID-19 and beyond. Furthermore, this study emphasizes that group interventions with other healthcare practitioners and the role of on-going longer WhatsApp-based interventions can become integral tools to support continued learning and patient safety practices.",2022,"This study highlights the effectiveness of online-based digital interventions as a convenient training tool for awareness and management of infectious diseases, leadership, and communication during COVID-19 and beyond.","['208 nurses (102 in the control group and 106 in the intervention group) who had been employed in the clinical setting during data collection', 'Nurses in Pakistan During the COVID-19 Pandemic']","['online-based digital interventions', 'WhatsApp-based intervention', 'WhatsApp-Delivered Intervention']","['learning in ""infection prevention and control"" and ""leadership and communication']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",,0.0238731,"This study highlights the effectiveness of online-based digital interventions as a convenient training tool for awareness and management of infectious diseases, leadership, and communication during COVID-19 and beyond.","[{'ForeName': 'Sara Rizvi', 'Initials': 'SR', 'LastName': 'Jafree', 'Affiliation': 'Department of Sociology, Forman Christian College University, Lahore, Pakistan.'}, {'ForeName': 'Rubeena', 'Initials': 'R', 'LastName': 'Zakar', 'Affiliation': 'Department of Public Health, Institute of Social and Cultural Studies, University of the Punjab, Lahore, Pakistan.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Rafiq', 'Affiliation': 'Shalamar Nursing College, Lahore, Pakistan.'}, {'ForeName': 'Ambreen', 'Initials': 'A', 'LastName': 'Javed', 'Affiliation': 'Department of English, Forman Christian College University, Lahore, Pakistan.'}, {'ForeName': 'Rana Rubab', 'Initials': 'RR', 'LastName': 'Durrani', 'Affiliation': 'Language Development Center, Forman Christian College University, Lahore, Pakistan.'}, {'ForeName': 'Syeda Khadija', 'Initials': 'SK', 'LastName': 'Burhan', 'Affiliation': 'Department of English, Forman Christian College University, Lahore, Pakistan.'}, {'ForeName': 'Syed Mujtaba', 'Initials': 'SM', 'LastName': 'Hasnain Nadir', 'Affiliation': 'Health Education England, North West Deanery, Leeds, United Kingdom.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Ali', 'Affiliation': 'CMH Lahore Medical College, Lahore, Pakistan.'}, {'ForeName': 'Aimen', 'Initials': 'A', 'LastName': 'Shahid', 'Affiliation': 'CMH Lahore Medical College, Lahore, Pakistan.'}, {'ForeName': 'Ain Ul', 'Initials': 'AU', 'LastName': 'Momina', 'Affiliation': 'Institute of Public Health, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Kamil J', 'Initials': 'KJ', 'LastName': 'Wrona', 'Affiliation': 'School of Public Health, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Qaisar Khalid', 'Initials': 'QK', 'LastName': 'Mahmood', 'Affiliation': 'Department of Sociology, International Islamic University, Islamabad, Pakistan.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Fischer', 'Affiliation': 'Institute of Public Health, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}]",Frontiers in public health,['10.3389/fpubh.2022.739761']
3360,35242683,Neoadjuvant pyrotinib plus trastuzumab and nab-paclitaxel for HER2-positive early or locally advanced breast cancer: an exploratory phase II trial.,"Background


The anti-tumor activity and acceptable tolerability of pyrotinib plus chemotherapy have been demonstrated in phase III trials in human epidermal growth factor receptor 2-positive metastatic breast cancer (BC). In this study, we assessed the efficacy and safety of neoadjuvant pyrotinib plus trastuzumab and albumin-bound paclitaxel in women with human epidermal growth factor receptor 2-positive early or locally advanced BC.
Methods


In this single-arm exploratory phase II trial, patients with untreated human epidermal growth factor receptor 2-positive BC (stage IIA-IIIC) received pyrotinib 400 mg once daily, trastuzumab 4 mg/kg loading dose, followed by 2 mg/kg once a week, and albumin-bound paclitaxel 125 mg/m 2  once a week for four 21-day cycles before surgery. The primary endpoint of the study was total pathological complete response (pCR) rate, defined as no microscopic invasive tumor remnants in the breast and axillary lymph nodes. The secondary endpoints were investigator-assessed objective response rate (ORR) and adverse event profiles.
Results


Between May 17, 2019 and November 26, 2019, a total of 21 patients were enrolled. The total pCR rate was 57.1% (12/21), whereas 23.8% (5/21) and 19.0% (4/21) of patients had minimal and moderate residual disease (RD), respectively. The ORR reached 100% (21/21) at the end of the neoadjuvant therapy. Grade ≥3 treatment-related adverse events were observed in 42.9% (9/21) of patients, including decreased neutrophil count [7 (33.3%)], diarrhoea [6 (28.6%)], decreased white blood cell count [5 (23.8%)], and vomiting [2 (9.5%)]. Adverse event-related dose reduction and interruption of pyrotinib occurred in 6 (28.6%) and 11 (52.4%) patients, respectively.
Conclusions


In women with human epidermal growth factor receptor 2-positive early or locally advanced BC, neoadjuvant pyrotinib plus trastuzumab and albumin-bound paclitaxel effectively promoted total pCR rate with an acceptable safety profile (ClinicalTrials.gov, NCT04152057).",2022,"Grade ≥3 treatment-related adverse events were observed in 42.9% (9/21) of patients, including decreased neutrophil count [7 (33.3%)], diarrhoea [6 (28.6%)], decreased white blood cell count [5 (23.8%)], and vomiting [2 (9.5%)].","['human epidermal growth factor receptor 2-positive metastatic breast cancer (BC', 'patients with untreated human epidermal growth factor receptor 2-positive BC (stage IIA-IIIC) received', 'Between May 17, 2019 and November 26, 2019, a total of 21 patients were enrolled', 'women with human epidermal growth factor receptor 2-positive early or locally advanced BC', 'HER2-positive early or locally advanced breast cancer']","['neoadjuvant pyrotinib plus trastuzumab and albumin-bound paclitaxel', 'pyrotinib 400 mg once daily, trastuzumab 4 mg/kg loading dose, followed by 2 mg/kg once a week, and albumin-bound paclitaxel', 'Neoadjuvant pyrotinib plus trastuzumab and nab-paclitaxel', 'pyrotinib plus chemotherapy']","['diarrhoea', 'Grade ≥3 treatment-related adverse events', 'investigator-assessed objective response rate (ORR) and adverse event profiles', 'Adverse event-related dose reduction and interruption of pyrotinib', 'neutrophil count', 'white blood cell count', 'total pathological complete response (pCR) rate, defined as no microscopic invasive tumor remnants in the breast and axillary lymph nodes', 'total pCR rate', 'efficacy and safety', 'vomiting']","[{'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441768', 'cui_str': 'Stage 2A'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3828434', 'cui_str': 'pyrotinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C3828434', 'cui_str': 'pyrotinib'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",21.0,0.120883,"Grade ≥3 treatment-related adverse events were observed in 42.9% (9/21) of patients, including decreased neutrophil count [7 (33.3%)], diarrhoea [6 (28.6%)], decreased white blood cell count [5 (23.8%)], and vomiting [2 (9.5%)].","[{'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': 'Department of Head, Neck, and Mammary Gland Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'Department of Head, Neck, and Mammary Gland Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Pathology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Head, Neck, and Mammary Gland Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wei', 'Affiliation': 'Department of Breast Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Breast Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Bu', 'Affiliation': 'Department of Breast Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Chinese Cochrane Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Tinglun', 'Initials': 'T', 'LastName': 'Tian', 'Affiliation': 'Department of Head, Neck, and Mammary Gland Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Lv', 'Affiliation': 'Department of Pathology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hongjiang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Pathology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Suo', 'Affiliation': 'Department of Head, Neck, and Mammary Gland Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Cancer Center, Affiliated Hospital of Xuzhou Medical University, Jiangsu Center for the Collaboration and Innovation of Cancer Biotherapy, Cancer Institute, Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Head, Neck, and Mammary Gland Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Luo', 'Affiliation': 'Department of Head, Neck, and Mammary Gland Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}]",Gland surgery,['10.21037/gs-21-911']
3361,35246396,"Intranasal low-level laser therapy versus acupuncture treatment for allergic rhinitis: A randomized, noninferiority trial.","INTRODUCTION


Intranasal low-level laser therapy (LLLT) has already proven its immunosuppressive effects on allergic rhinitis (AR) in experimental studies; however, there is a dearth of clinical evidence supporting its effects in treating AR. The aim of this study was to assess the safety and effectiveness of intranasal LLLT in the treatment of AR compared with acupuncture.
METHODS


A total of 80 patients with AR participated and were randomly assigned to the intranasal LLLT or acupuncture treatment (AT) group. They were given each treatment for 20 min 3 times a week for 4 weeks.
RESULTS


Both groups improved the total nasal symptom score (TNSS), rhinoconjunctivitis quality of life questionnaire (RQLQ) score, and nasal endoscopy index in patients with AR after 4 weeks of treatment, and these effects extended 4 weeks after the end of treatment. Intranasal LLLT was noninferior to AT in regard to the TNSS. The estimated outcome difference between baseline and the 5th week was -0.38 points (upper 97.5% confidence limit 1.06 points), which was within the noninferiority margin of 2 points. The effect size of the TNSS at the 5th week was 0.19, which was close to Cohen's small effect size. There were no significant differences between two groups regarding the RQLQ, nasal endoscopy index, total serum immunoglobulin E level or absolute eosinophil count.
CONCLUSION


This study showed that intranasal LLLT is noninferior compared to AT in terms of the TNSS; thus, it may be used as an alternative or adjunctive treatment option for relieving symptoms of AR.
TRIAL REGISTRATION


This study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0004079).",2022,"Both groups improved the total nasal symptom score (TNSS), rhinoconjunctivitis quality of life questionnaire (RQLQ) score, and nasal endoscopy index in patients with AR after 4 weeks of treatment, and these effects extended 4 weeks after the end of treatment.","['allergic rhinitis', '80 patients with AR participated']","['acupuncture', 'Intranasal low-level laser therapy (LLLT', 'intranasal LLLT', 'Intranasal low-level laser therapy', 'TNSS', 'intranasal LLLT or acupuncture', 'Intranasal LLLT']","['safety and effectiveness', 'RQLQ, nasal endoscopy index, total serum immunoglobulin E level or absolute eosinophil count', 'total nasal symptom score (TNSS), rhinoconjunctivitis quality of life questionnaire (RQLQ) score, and nasal endoscopy index']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0856520', 'cui_str': 'Serum immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",80.0,0.142593,"Both groups improved the total nasal symptom score (TNSS), rhinoconjunctivitis quality of life questionnaire (RQLQ) score, and nasal endoscopy index in patients with AR after 4 weeks of treatment, and these effects extended 4 weeks after the end of treatment.","[{'ForeName': 'JeongIn', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Deptartment of Ophthalmology, Otolaryngology, and Dermatology, College of Korean Medicine, Woo-Suk University, 54987, 46 Eoeun-ro, Wansan-gu, Jeonju-si, Jeollabuk-do, Republic of Korea. Electronic address: jeongin1010@hanmail.net.'}, {'ForeName': 'MiJu', 'Initials': 'M', 'LastName': 'Son', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, 34054, 1672, Yuseongdae-ro, Yuseong-gu, Daejeon, Republic of Korea. Electronic address: mj714@kiom.re.kr.'}, {'ForeName': 'YoungEun', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Future Medicine Division, Korea Institute of Oriental Medicine, 34054, 1672, Yuseongdae-ro, Yuseong-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'EunHee', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics & Gynecology, College of Korean Medicine, Woo-Suk University, 54987, 46 Eoeun-ro, Wansan-gu, Jeonju-si, Jeollabuk-do, Republic of Korea.'}, {'ForeName': 'NamHun', 'Initials': 'N', 'LastName': 'Heo', 'Affiliation': 'Clinical Trial Center, Soonchunhyang University Hospital, 31151, 31, Suncheonhyang 6-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea.'}, {'ForeName': 'NamKwen', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'National Institute for Korean Medicine Development, 04554, 173, Toegye-ro, Jung-gu, Seoul, Republic of Korea.'}, {'ForeName': 'SuRan', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'National Institute for Korean Medicine Development, 04554, 173, Toegye-ro, Jung-gu, Seoul, Republic of Korea.'}, {'ForeName': 'DongHyo', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Deptartment of Ophthalmology, Otolaryngology, and Dermatology, College of Korean Medicine, Woo-Suk University, 54987, 46 Eoeun-ro, Wansan-gu, Jeonju-si, Jeollabuk-do, Republic of Korea. Electronic address: drleedh@naver.com.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2022.02.006']
3362,35246395,The effect of Tianjiang Xueshuantong Wan pills on ischemia-reperfusion injury after thrombolysis in acute cerebral infarction.,"OBJECTIVE


The aim of this study is to investigate the effect of Tianjiang Xueshuantong Wan pills on reperfusion injury after venous thrombolysis in acute cerebral infarction.
METHODS


The strategy used in this study is a randomised controlled clinical trial. In total, 72 cases were included, with 36 in the trial group and 36 in the control group, with a 1:1 ratio. Both groups were given standardised treatment for acute cerebral infarction. Based on the rt-PA intravenous thrombolysis, the test group took Tianjiang Xueshuantong Wan pills orally, whereas the control group solely utilised rt-PA for intravenous thrombolysis and did not take the test medicine orally. The patients' intracranial hemorrhage was clarified by head CT scan, and the occurrence of reperfusion injury was recorded during the entire trial.
RESULTS


There were no significant differences in serum IL-6, MDA, SOD and TNF concentrations and NIHSS scores between the two groups before therapy (P > 0.05). After treatment, the serum concentrations of IL-6, MDA and TNF in the experimental group were significantly decreased compared with the control group, while the serum concentrations of SOD were significantly increased compared with the control group, with statistical significance (P > 0.05). After seven days of treatment, the total effective rate in the experimental group was 88.89%, while the data in the control group was 75%. There was a statistically significant difference between the experimental and control groups.
CONCLUSION


Tianjiang Xueshuantong Wan pills can effectively prevent reperfusion injury following intravenous thrombolysis in individuals with cerebral infarction while improving patients' neurological deficits.",2022,"There were no significant differences in serum IL-6, MDA, SOD and TNF concentrations and NIHSS scores between the two groups before therapy (P > 0.05).","['acute cerebral infarction', 'individuals with cerebral infarction', 'In total, 72 cases were included, with 36 in the trial group and 36 in the control group, with a 1:1 ratio']",['Tianjiang Xueshuantong Wan pills'],"['serum concentrations of IL-6, MDA and TNF', 'total effective rate', 'intracranial hemorrhage', 'serum IL-6, MDA, SOD and TNF concentrations and NIHSS scores', 'serum concentrations of SOD']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C1956628', 'cui_str': 'Panax notoginseng extract'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",72.0,0.0394607,"There were no significant differences in serum IL-6, MDA, SOD and TNF concentrations and NIHSS scores between the two groups before therapy (P > 0.05).","[{'ForeName': 'Rui Xian', 'Initials': 'RX', 'LastName': 'Wang', 'Affiliation': 'Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin 300120, China. Electronic address: ruixianw_wang15@163.com.'}, {'ForeName': 'Yajuan', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin 300120, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin 300120, China.'}, {'ForeName': 'Xiangning', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin 300120, China.'}, {'ForeName': 'Yue Hui', 'Initials': 'YH', 'LastName': 'Wang', 'Affiliation': 'Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin 300120, China.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin 300120, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin 300120, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jie', 'Affiliation': ""Department of neurological Intervention, Shandong Lanling People's Hospital, China.""}]","Explore (New York, N.Y.)",['10.1016/j.explore.2022.02.002']
3363,35246387,Exploring the factors which impact overall satisfaction with single vision contact lenses.,"PURPOSE


To explore the impact of subjective factors (lens handling, comfort and vision) on overall single vision contact lens satisfaction.
METHODS


Correlation analysis of a prospective, randomised, double-masked, bilateral crossover study involving 55 adapted lens wearers fitted with somofilcon A (SiHy) (clariti® 1 day, CooperVision) and etafilcon A (Hy) (1 DAY ACUVUE® MOIST, Johnson & Johnson Vision) was conducted. Subjective ratings of lens handling, comfort and vision collected after 1 week of lens wear for each lens type were correlated with overall satisfaction. Data were analysed by combining data for both lens types and also for each lens separately.
RESULTS


For the combined analysis, significant correlations (p < 0.01) were found between subjective ratings of overall satisfaction and ratings of handing for application (r = 0.64), handling for removal (r = 0.50), comfort upon application (r = 0.59), comfort at end of day (r = 0.61), overall satisfaction with comfort (r = 0.88) and overall satisfaction with vision (r = 0.64). Correlation analysis of the per lens data showed that lens specific correlations of overall satisfaction with handling for lens application varied greatly with lens material (SiHy: r = 0.26, p = 0.05 vs Hy: r = 0.72, p < 0.01). Correlation strength of comfort upon application/at end of day with overall satisfaction also varied with lens material (Application: SiHy: r = 0.40 vs Hy: r = 0.61; End of day: SiHy: r = 0.76 vs Hy: r = 0.58; all p ≤ 0.01).
CONCLUSION


Overall satisfaction was significantly correlated with the specific subjective evaluations of handling, vision and comfort. Correlations of overall satisfaction and ease of handling for each lens type suggest that, for habitual contact lens wearers, dissatisfaction with handling at the time of lens application can play a major role in overall dissatisfaction with a lens. Handling for application had a similar correlation (r) value as vision, suggesting that handling for application should not be underestimated when considering overall patient satisfaction.",2022,"Handling for application had a similar correlation (r) value as vision, suggesting that handling for application should not be underestimated when considering overall patient satisfaction.",['55 adapted lens wearers fitted with'],"['somofilcon A (SiHy) (clariti® 1\xa0day, CooperVision) and etafilcon A']","['handling for removal', 'Subjective ratings of lens handling, comfort and vision', 'Overall satisfaction', 'overall satisfaction with comfort', 'subjective ratings of overall satisfaction and ratings of handing for application', 'overall satisfaction with vision', 'specific subjective evaluations of handling, vision and comfort']","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0756851', 'cui_str': 'etafilcon'}]","[{'cui': 'C0018578', 'cui_str': 'Handling (Psychology)'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",55.0,0.115502,"Handling for application had a similar correlation (r) value as vision, suggesting that handling for application should not be underestimated when considering overall patient satisfaction.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Centre for Ocular Research & Education (CORE), School of Optometry & Vision Science, University of Waterloo, 200 University Avenue West, Waterloo, Ontario N2L 3G1, Canada. Electronic address: sarah.guthrie@uwaterloo.ca.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Ng', 'Affiliation': 'Centre for Ocular Research & Education (CORE), School of Optometry & Vision Science, University of Waterloo, 200 University Avenue West, Waterloo, Ontario N2L 3G1, Canada.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Woods', 'Affiliation': 'Centre for Ocular Research & Education (CORE), School of Optometry & Vision Science, University of Waterloo, 200 University Avenue West, Waterloo, Ontario N2L 3G1, Canada.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Vega', 'Affiliation': 'CooperVision Incorporated, 6101 Bollinger Canyon Rd, Suite 500, San Ramon, CA 94583, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Orsborn', 'Affiliation': 'CooperVision Incorporated, 6101 Bollinger Canyon Rd, Suite 500, San Ramon, CA 94583, USA.'}, {'ForeName': 'Lyndon', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Centre for Ocular Research & Education (CORE), School of Optometry & Vision Science, University of Waterloo, 200 University Avenue West, Waterloo, Ontario N2L 3G1, Canada; Centre for Eye and Vision Research (CEVR), 17W Hong Kong Science Park, Hong Kong.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2022.101579']
3364,35246380,Implementing Lean Techniques to Increase the Efficiency of a Rural Primary Care Clinic: A Prospective Controlled Study.,"BACKGROUND


Lean, a management approach focused on identifying and eliminating waste, has been proposed as a solution for shortages in health care. Many studies implementing Lean in health care have lacked adequately designed controls.
METHODS


This was a prospective, block randomized, controlled study conducted in a single primary care clinic comprising three primary care providers. A multidisciplinary team constructed a value stream, proposing foci of waste and possible solutions. These were implemented during three consecutive eight-week blocks. A sample was taken of 40 random visits for each physician during each block, and one physician was randomized to implement the interventions while the other two served as controls.
RESULTS


Intervention blocks were significantly shorter compared to control blocks, with a mean difference (MD) of -1,190 seconds (s) (95% confidence interval = 1,039-1,342, p < 0.001). This was primarily the result of four interventions: (1) relocating the printer to the front desk (MD -378 s, p < 0.001), (2) adding another parallel working station (MD -258 s uploading the patient's file and MD -138 s uploading the history, p < 0.001 for both), (3) documenting in plain typing (MD -229 s, p < 0.001), and (4) rerouting delayed patients to the next available physician (MD -195 s, p = 0.004). Two steps were modestly lengthened: anamnesis (MD 24 s, p < 0.001) and explaining the diagnosis and treatment plan (MD 11 s, p = 0.001). Average productivity was increased by 1.65 appointments per hour (p < 0.001). Burnout scores decreased from an average of 74 points during control blocks to 63.8 on intervention (p < 0.01). No clinically or statistically significant difference was noted in quality of care, definitivity of treatment, or patient satisfaction (p = 0.83, 0.55, and 0.77, respectively).
CONCLUSION


Intrinsically led, multidisciplinary Lean implementation in a rural primary care clinic dramatically shortened the value stream duration, while requiring no extrinsic resources. Widening Lean implementation and research in primary care, particularly in rural settings, may increase the availability and effectiveness of primary care.",2022,Average productivity was increased by 1.65 appointments per hour (p < 0.001).,['single primary care clinic comprising three primary care providers'],[],"['quality of care, definitivity of treatment, or patient satisfaction', 'Average productivity']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}]",[],"[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",3.0,0.0551278,Average productivity was increased by 1.65 appointments per hour (p < 0.001).,"[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Gur', 'Affiliation': ''}, {'ForeName': 'Shachar', 'Initials': 'S', 'LastName': 'Shapira', 'Affiliation': ''}, {'ForeName': 'Nataly', 'Initials': 'N', 'LastName': 'Halloun', 'Affiliation': ''}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Kaisari', 'Affiliation': ''}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Stern', 'Affiliation': ''}]",Joint Commission journal on quality and patient safety,['10.1016/j.jcjq.2022.01.009']
3365,35246356,"Virtual reality during work breaks to reduce fatigue of intensive unit caregivers: A crossover, pilot, randomised trial.","PURPOSE


Intensive care unit (ICU) caregivers are exposed to high levels of stress. Work-related stress can impact quality of life and may lead to burnout. Virtual reality (VR) simulates a person's presence in a pleasant and enjoyable artificial environment. Thus, VR may be used to improve breaktime efficacy during the work shift of ICU caregivers.
OBJECTIVE


The study objectives were to evaluate the feasibility and efficacy of VR to decrease stress, anxiety, and fatigue, as well as to increase work disconnection during the breaktime.
METHODS


We conducted a prospective, monocentric, open-label, crossover, randomised study comparing a half an hour breaktime including an 8-min-long VR session and a usual breaktime among ICU caregivers, on two consecutive work shifts. Participants were evaluated before and after the breaktime as well as at the end of the work shift for stress, anxiety, fatigue, and work disconnection using visual analog scales.
RESULTS


For the 88 participants, VR was easy to use. VR induced a significantly higher reduction in the fatigue score after the breaktime. Individual changes in the fatigue score were +0.17 (1.87) vs. -0.33 (1.87). A significantly higher feeling of disconnection from the work environment at the end of the breaktime was also observed with VR: 5.98 (3.04) vs. 4.20 (2.64). No significant difference was observed for other parameters, in particular at the end of the shift.
CONCLUSION


VR sessions could improve the efficacy of breaktimes among ICU caregivers and contribute to a better quality of work life; repeated or longer sessions may be required to induce sustained effects.",2022,A significantly higher feeling of disconnection from the work environment at the end of the breaktime was also observed with VR: 5.98 (3.04) vs. 4.20 (2.64).,['intensive unit caregivers'],"['VR sessions', '8-min-long VR session']","['stress, anxiety, and fatigue', 'fatigue score', 'breaktime efficacy', 'feeling of disconnection', 'stress, anxiety, fatigue, and work disconnection using visual analog scales']","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",88.0,0.0405278,A significantly higher feeling of disconnection from the work environment at the end of the breaktime was also observed with VR: 5.98 (3.04) vs. 4.20 (2.64).,"[{'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Bodet-Contentin', 'Affiliation': 'Médecine Intensive Réanimation, INSERM CIC 1415, CRICS-TriGGERSep Network, CHRU de Tours and MethodS in Patient-centered Outcomes and Health ResEarch (SPHERE), INSERM UMR 1246, Université de Tours, France. Electronic address: laetitia.bodet@univ-tours.fr.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Letourneur', 'Affiliation': 'Médecine Intensive Réanimation, CHRU de Tours, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': ""Médecine Intensive Réanimation, INSERM CIC 1415, CRICS-TriGGERSep Network, CHRU de Tours and Centre d'Etude des Pathologies Respiratoires (CEPR), INSERM UMR 1100, Université de Tours, France.""}]",Australian critical care : official journal of the Confederation of Australian Critical Care Nurses,['10.1016/j.aucc.2022.01.009']
3366,33891981,Mapping atopic dermatitis and anti-IL-22 response signatures to type 2-low severe neutrophilic asthma.,"BACKGROUND


Transcriptomic changes in patients who respond clinically to biological therapies may identify responses in other tissues or diseases.
OBJECTIVE


We sought to determine whether a disease signature identified in atopic dermatitis (AD) is seen in adults with severe asthma and whether a transcriptomic signature for patients with AD who respond clinically to anti-IL-22 (fezakinumab [FZ]) is enriched in severe asthma.
METHODS


An AD disease signature was obtained from analysis of differentially expressed genes between AD lesional and nonlesional skin biopsies. Differentially expressed genes from lesional skin from therapeutic superresponders before and after 12 weeks of FZ treatment defined the FZ-response signature. Gene set variation analysis was used to produce enrichment scores of AD and FZ-response signatures in the Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes asthma cohort.
RESULTS


The AD disease signature (112 upregulated genes) encompassing inflammatory, T-cell, T H 2, and T H 17/T H 22 pathways was enriched in the blood and sputum of patients with asthma with increasing severity. Patients with asthma with sputum neutrophilia and mixed granulocyte phenotypes were the most enriched (P < .05). The FZ-response signature (296 downregulated genes) was enriched in asthmatic blood (P < .05) and particularly in neutrophilic and mixed granulocytic sputum (P < .05). These data were confirmed in sputum of the Airway Disease Endotyping for Personalized Therapeutics cohort. IL-22 mRNA across tissues did not correlate with FZ-response enrichment scores, but this response signature correlated with T H 22/IL-22 pathways.
CONCLUSIONS


The FZ-response signature in AD identifies severe neutrophilic asthmatic patients as potential responders to FZ therapy. This approach will help identify patients for future asthma clinical trials of drugs used successfully in other chronic diseases.",2022,The FZ-response signature (296 downregulated genes) was enriched in asthmatic blood (P < .05) and particularly in neutrophilic and mixed granulocytic sputum (P < .05).,"['adults with severe asthma and whether a transcriptomic signature for patients with AD who respond clinically to anti-IL-22 (fezakinumab [FZ', 'Patients with asthma with sputum neutrophilia and mixed granulocyte phenotypes', 'type 2-low severe neutrophilic asthma']",[],"['asthmatic blood', 'neutrophilic and mixed granulocytic sputum']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0961814', 'cui_str': 'interleukin-22'}, {'cui': 'C2981359', 'cui_str': 'fezakinumab'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0151683', 'cui_str': 'Neutrophilia'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2363774', 'cui_str': 'Neutrophilic asthma'}]",[],"[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}]",,0.0644394,The FZ-response signature (296 downregulated genes) was enriched in asthmatic blood (P < .05) and particularly in neutrophilic and mixed granulocytic sputum (P < .05).,"[{'ForeName': 'Yusef Eamon', 'Initials': 'YE', 'LastName': 'Badi', 'Affiliation': 'National Heart and Lung Institute, the Imperial College London, London, United Kingdom; NIHR Imperial Biomedical Research Centre, London, United Kingdom; Data Science Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Pavel', 'Affiliation': 'Laboratory of Inflammatory Skin Diseases, Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY; Department of Biomedical Engineering, The University of Mississippi, Oxford, Miss.'}, {'ForeName': 'Stelios', 'Initials': 'S', 'LastName': 'Pavlidis', 'Affiliation': 'Data Science Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Riley', 'Affiliation': 'GSK Respiratory Therapeutic Area Unit, Stevenage, United Kingdom.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Bates', 'Affiliation': 'GSK Respiratory Therapeutic Area Unit, Stevenage, United Kingdom.'}, {'ForeName': 'Nazanin Zounemat', 'Initials': 'NZ', 'LastName': 'Kermani', 'Affiliation': 'Data Science Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Knowles', 'Affiliation': 'Knowles Consulting, Stevenage, United Kingdom.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Kolmert', 'Affiliation': 'Centre for Allergy Research, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden; Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Wheelock', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Worsley', 'Affiliation': 'GSK Value Evidence and Outcomes, Brentford, United Kingdom.'}, {'ForeName': 'Mohib', 'Initials': 'M', 'LastName': 'Uddin', 'Affiliation': 'Respiratory Global Medicines Development, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Alving', 'Affiliation': ""Department of Women's and Children's Health: Paediatric Research, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Per S', 'Initials': 'PS', 'LastName': 'Bakke', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Annelie', 'Initials': 'A', 'LastName': 'Behndig', 'Affiliation': 'Department of Public Health and Clinical Medicine, Division of Medicine/Respiratory Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Caruso', 'Affiliation': 'Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Chanez', 'Affiliation': 'Aix-Marseille Universite, Assistance Publique des Hopitaux de Marseille, Clinic des Bronches, Allergies et Sommeil, Marseille, France.'}, {'ForeName': 'Louise J', 'Initials': 'LJ', 'LastName': 'Fleming', 'Affiliation': 'National Heart and Lung Institute, the Imperial College London, London, United Kingdom; NIHR Imperial Biomedical Research Centre, London, United Kingdom.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Fowler', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, United Kingdom; Manchester Academic Health Science Centre and NIHR Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Frey', 'Affiliation': ""University Children's Hospital Basel, University of Basel, Basel, Switzerland.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Howarth', 'Affiliation': ""Clinical and Experimental Sciences and Human Development in Health, University of Southampton Faculty of Medicine, Southampton, United Kingdom; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; David Hide Asthma and Allergy Research Centre, St Mary's Hospital, Newport, Isle of Wight, United Kingdom.""}, {'ForeName': 'Ildikó', 'Initials': 'I', 'LastName': 'Horváth', 'Affiliation': 'Department of Public Health, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Krug', 'Affiliation': 'Fraunhofer ITEM, Hannover, Germany.'}, {'ForeName': 'Anke H', 'Initials': 'AH', 'LastName': 'Maitland-van der Zee', 'Affiliation': 'Department of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Montuschi', 'Affiliation': 'Pharmacology, Catholic University of the Sacred Heart, Agostino Gemelli University Hospital Foundation, Rome, Italy.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': ""Clinical and Experimental Sciences and Human Development in Health, University of Southampton Faculty of Medicine, Southampton, United Kingdom; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; David Hide Asthma and Allergy Research Centre, St Mary's Hospital, Newport, Isle of Wight, United Kingdom.""}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Sanak', 'Affiliation': 'Department of Internal Medicine, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Dominick E', 'Initials': 'DE', 'LastName': 'Shaw', 'Affiliation': 'University of Nottingham, NIHR Biomedical Research Centre, Nottingham, United Kingdom.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Singer', 'Affiliation': 'Division of Respiratory Medicine, Department of Paediatrics, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Sterk', 'Affiliation': 'Department of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ratko', 'Initials': 'R', 'LastName': 'Djukanovic', 'Affiliation': ""Clinical and Experimental Sciences and Human Development in Health, University of Southampton Faculty of Medicine, Southampton, United Kingdom; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; David Hide Asthma and Allergy Research Centre, St Mary's Hospital, Newport, Isle of Wight, United Kingdom.""}, {'ForeName': 'Sven-Eric', 'Initials': 'SE', 'LastName': 'Dahlen', 'Affiliation': 'Centre for Allergy Research, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Yi-Ke', 'Initials': 'YK', 'LastName': 'Guo', 'Affiliation': 'Data Science Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Kian Fan', 'Initials': 'KF', 'LastName': 'Chung', 'Affiliation': 'National Heart and Lung Institute, the Imperial College London, London, United Kingdom; NIHR Imperial Biomedical Research Centre, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Laboratory of Inflammatory Skin Diseases, Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Adcock', 'Affiliation': 'National Heart and Lung Institute, the Imperial College London, London, United Kingdom; NIHR Imperial Biomedical Research Centre, London, United Kingdom. Electronic address: ian.adcock@imperial.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2021.04.010']
3367,35241345,No effect of triheptanoin in patients with phosphofructokinase deficiency.,"Phosphofructokinase deficiency (PFKD) is a rare disorder of glycogen metabolism. The lack of phosphofructokinase activity blocks the oxidative pathway from glucose and glycogen to pyruvate. Patients suffer from myopathy, exercise intolerance, and myoglobinuria. Currently, there is no specific treatment for PFKD. We hypothesized that 2 weeks treatment with triheptanoin could improve oxidative metabolism during exercise by bypassing the blocked pyruvate generation in PFKD. The study was a randomized, double-blind, placebo-controlled crossover study. Three genetically verified patients completed two treatment periods of 14 days each with triheptanoin (0.3-1 g × kg -1  × day -1 ) or placebo liquid. Primary outcomes were heart rate, fatty acid and total oxidation measured via stable isotope and indirect calorimetry methodology during submaximal exercise. Triheptanoin did not improve the primary outcome heart rate during submaximal exercise compared to placebo. Palmitate oxidation was increased during submaximal exercise in one patient but did not increase in the two other patients during triheptanoin treatment. Palmitate production and palmitate utilization increased during exercise and increased to a greater extent with triheptanoin treatment in all three patients. This study suggests that triheptanoin treatment has no effect on heart rate or exercise performance despite increased palmitate production and utilization in patients with PFKD.",2022,Palmitate production and palmitate utilization increased during exercise and increased to a greater extent with triheptanoin treatment in all three patients.,"['Patients suffer from myopathy, exercise intolerance, and myoglobinuria', 'patients with PFKD', 'patients with phosphofructokinase deficiency']","['triheptanoin', 'Triheptanoin', 'placebo', 'placebo liquid']","['heart rate, fatty acid and total oxidation measured via stable isotope and indirect calorimetry methodology during submaximal exercise', 'heart rate or exercise performance', 'oxidative metabolism', 'Palmitate production and palmitate utilization', 'Palmitate oxidation', 'primary outcome heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0424551', 'cui_str': 'Impaired exercise tolerance'}, {'cui': 'C0027080', 'cui_str': 'Myoglobinuria'}, {'cui': 'C0017926', 'cui_str': 'Glycogen storage disease, type VII'}]","[{'cui': 'C2604598', 'cui_str': 'triheptanoin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282636', 'cui_str': 'Respiration, Cell'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",3.0,0.166442,Palmitate production and palmitate utilization increased during exercise and increased to a greater extent with triheptanoin treatment in all three patients.,"[{'ForeName': 'Daniel Emil', 'Initials': 'DE', 'LastName': 'Raaschou-Pedersen', 'Affiliation': 'Copenhagen Neuromuscular Center, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: Daniel.raaschou@gmail.com.'}, {'ForeName': 'Karen Lindhardt', 'Initials': 'KL', 'LastName': 'Madsen', 'Affiliation': 'Copenhagen Neuromuscular Center, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nicoline', 'Initials': 'N', 'LastName': 'Løkken', 'Affiliation': 'Copenhagen Neuromuscular Center, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jesper Helbo', 'Initials': 'JH', 'LastName': 'Storgaard', 'Affiliation': 'Copenhagen Neuromuscular Center, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ros', 'Initials': 'R', 'LastName': 'Quinlivan', 'Affiliation': 'MRC Centre for Neuromuscular Diseases, National Hospital for Neurology and Neurosurgery, Queen Square, London, England UK.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Laforêt', 'Affiliation': 'Neurology Department, Nord/Est/Ile de France neuromuscular center, Raymond-Poincaré Hospital, INSERM U1179, END-ICAP, Versailles Saint-Quentin-en-Yvelines University, Montigny-le-Bretonneux, Garches, France.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'Center for Inherited Metabolic Diseases, Departments of Pediatrics and Clinical Genetics, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Van Hall', 'Affiliation': 'Clinical Metabolomics Core Facility, Clinical Biochemistry, Copenhagen. University Hospital & Department of Biomedical Sciences, Faculty of Health & Medical Sciences University of Copenhagen, Copenhagen Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': 'Copenhagen Neuromuscular Center, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Ørngreen', 'Affiliation': 'Copenhagen Neuromuscular Center, Copenhagen University Hospital, Copenhagen, Denmark; Center for Inherited Metabolic Diseases, Departments of Pediatrics and Clinical Genetics, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Neuromuscular disorders : NMD,['10.1016/j.nmd.2022.01.012']
3368,35241317,Curettage and electrocoagulation versus surgical excision in the treatment of low-risk basal cell carcinoma - Postoperative follow up and satisfaction at three months: randomized clinical trial.,,2022,,[],['Curettage and electrocoagulation versus surgical excision'],[],[],"[{'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0728940', 'cui_str': 'Excision'}]",[],,0.282516,,"[{'ForeName': 'Luan Moura Hortencio', 'Initials': 'LMH', 'LastName': 'Bastos', 'Affiliation': 'Department of Infectology, Dermatology, Diagnostic Imaging and Radiotherapy, Faculty of Medicine, Universidade Estadual Paulista, Botucatu, SP, Brazil.'}, {'ForeName': 'Larissa Pierri', 'Initials': 'LP', 'LastName': 'Carvalho', 'Affiliation': 'Department of Infectology, Dermatology, Diagnostic Imaging and Radiotherapy, Faculty of Medicine, Universidade Estadual Paulista, Botucatu, SP, Brazil.'}, {'ForeName': 'Gabriela Roncada', 'Initials': 'GR', 'LastName': 'Haddad', 'Affiliation': 'Department of Infectology, Dermatology, Diagnostic Imaging and Radiotherapy, Faculty of Medicine, Universidade Estadual Paulista, Botucatu, SP, Brazil.'}, {'ForeName': 'Anna Carolina', 'Initials': 'AC', 'LastName': 'Miola', 'Affiliation': 'Department of Infectology, Dermatology, Diagnostic Imaging and Radiotherapy, Faculty of Medicine, Universidade Estadual Paulista, Botucatu, SP, Brazil.'}, {'ForeName': 'Juliano Vilaverde', 'Initials': 'JV', 'LastName': 'Schmitt', 'Affiliation': 'Department of Infectology, Dermatology, Diagnostic Imaging and Radiotherapy, Faculty of Medicine, Universidade Estadual Paulista, Botucatu, SP, Brazil. Electronic address: juliano.schmitt@unesp.br.'}]",Anais brasileiros de dermatologia,['10.1016/j.abd.2020.12.011']
3369,35241252,"Retraction and republication-Stereotactic body radiotherapy plus pembrolizumab and trametinib versus stereotactic body radiotherapy plus gemcitabine for locally recurrent pancreatic cancer after surgical resection: an open-label, randomised, controlled, phase 2 trial.",,2022,,['locally recurrent pancreatic cancer after surgical resection'],['Retraction and republication-Stereotactic body radiotherapy plus pembrolizumab and trametinib versus stereotactic body radiotherapy plus gemcitabine'],[],"[{'cui': 'C0854777', 'cui_str': 'Pancreatic carcinoma recurrent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]",[],,0.0206082,,"[{'ForeName': '', 'Initials': '', 'LastName': 'The Editors Of The Lancet Oncology', 'Affiliation': 'The Lancet Oncology, London EC2Y 5AS, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(22)00064-X']
3370,35241246,Baseline Characteristics of Patients With HF With Mildly Reduced and Preserved Ejection Fraction: DELIVER Trial.,"OBJECTIVES


This report describes the baseline clinical profiles and management of DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) trial participants and how these compare with those in other contemporary heart failure with preserved ejection fraction trials.
BACKGROUND


The DELIVER trial was designed to evaluate the effects of the sodium-glucose cotransporter-2 inhibitor dapagliflozin on cardiovascular death, heart failure (HF) hospitalization, or urgent HF visits in patients with HF with mildly reduced and preserved left ventricular ejection fraction (LVEF).
METHODS


Adults with symptomatic HF and LVEF >40%, with or without type 2 diabetes mellitus, elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, and evidence of structural heart disease were randomized to dapagliflozin 10 mg once daily or matching placebo.
RESULTS


A total of 6,263 patients were randomized (mean age: 72 ± 10 years; 44% women; 45% type 2 diabetes mellitus; 45% with body mass index ≥30 kg/m 2 ; and 57% with history of atrial fibrillation or flutter). Most participants had New York Heart Association functional class II symptoms (75%). Baseline mean LVEF was 54.2 ± 8.8% and median NT-proBNP of 1,399 pg/mL (IQR: 962 to 2,210 pg/mL) for patients in atrial fibrillation/flutter compared with 716 pg/mL (IQR: 469 to 1,281 pg/mL) in those who were not. Patients in both hospitalized and ambulatory settings were enrolled, including 10% enrolled in-hospital or within 30 days of a hospitalization for HF. Eighteen percent of participants had HF with improved LVEF.
CONCLUSIONS


DELIVER is the largest and broadest clinical trial of this population to date and enrolled high-risk, well-treated patients with HF with mildly reduced and preserved LVEF. (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure [NCT03619213]).",2022,"Baseline mean LVEF was 54.2 ± 8.8% and median NT-proBNP of 1,399 pg/mL (IQR: 962 to 2,210 pg/mL) for patients in atrial fibrillation","['6,263 patients were randomized (mean age: 72 ± 10 years; 44% women; 45% type 2 diabetes mellitus; 45% with body mass index\xa0≥30\xa0kg', 'patients with HF with mildly reduced and preserved left ventricular ejection fraction (LVEF', 'Patients With HF', 'Patients in both hospitalized and ambulatory settings were enrolled, including 10% enrolled in-hospital or within 30\xa0days of a hospitalization for HF', 'Most participants had New York Heart Association functional class II symptoms (75', 'Adults with symptomatic HF and LVEF >40%, with or without type 2 diabetes mellitus, elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, and evidence of structural heart disease', 'With Preserved Ejection Fraction Heart\xa0Failure']","['sodium-glucose cotransporter-2 inhibitor dapagliflozin', 'dapagliflozin 10\xa0mg once daily or matching placebo']","['atrial fibrillation', 'cardiovascular death, heart failure (HF) hospitalization, or urgent HF visits', 'HF with improved LVEF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",6263.0,0.217993,"Baseline mean LVEF was 54.2 ± 8.8% and median NT-proBNP of 1,399 pg/mL (IQR: 962 to 2,210 pg/mL) for patients in atrial fibrillation","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: ssolomon@bwh.harvard.edu.""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'DeMets', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA.""}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'University of Groningen, Groningen, the Netherlands; National Heart Centre Singapore & Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Martinez', 'Affiliation': 'University of Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Belohlavek', 'Affiliation': 'General University Hospital, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chiang', 'Affiliation': 'General Clinical Research Center and Division of Cardiology, Taipei Veterans General Hospital and National Yang Ming Chiao Tung University, Taipei, Taiwan.'}, {'ForeName': 'C Jan', 'Initials': 'CJ', 'LastName': 'Willem Borleffs', 'Affiliation': 'Haga Teaching Hospital, The Hague, Netherlands.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comin-Colet', 'Affiliation': 'Cardiology Department, Bellvitge University Hospital, Bio-Heart (IDIBELL), University of Barcelona, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Dobreanu', 'Affiliation': 'University of Medicine, Pharmacy, Science and Technology ""G.E.Palade,"" Târgu Mureș, Romania.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Drozdz', 'Affiliation': 'Department Cardiology, Medical University Lodz, Lodz, Poland.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Fang', 'Affiliation': 'University of Utah Medical Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Alcocer Gamba', 'Affiliation': 'Centro de Estudios Clínicos de Querétaro (CECLIQ), Querétaro, México.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Al Habeeb', 'Affiliation': 'Cardiac Sciences Department, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Cardiovascular Research Institute, Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Jose Walter', 'Initials': 'JW', 'LastName': 'Cabrera Honorio', 'Affiliation': 'Clínica Vesalio, San Borja, Peru.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Janssens', 'Affiliation': 'Cardiac Intensive Care, Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Tsvetana', 'Initials': 'T', 'LastName': 'Katova', 'Affiliation': 'Department of Noninvasive Cardiology, National Cardiology Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Kinshukai Hanwa Daini Senboku Hospital, Osaka, JapanHeart and Vascular Center.'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Institut de Cardiologie de Montréal, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Jose Francisco', 'Initials': 'JF', 'LastName': 'Kerr Saraiva', 'Affiliation': 'Cardiovascular Division, Instituto de Pesquisa Clínica de Campinas, Campinas SP, Brazil.'}, {'ForeName': 'Sergey N', 'Initials': 'SN', 'LastName': 'Tereschenko', 'Affiliation': 'Department of Myocardial Disease and Heart Failure, National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Thierer', 'Affiliation': 'Jefe de Unidad de Insuficiencia Cardíaca, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno (CEMIC), Argentina.'}, {'ForeName': 'Orly', 'Initials': 'O', 'LastName': 'Vardeny', 'Affiliation': 'Minneapolis VA Center for Care Delivery and Outcomes Research, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Pham Nguyen', 'Initials': 'PN', 'LastName': 'Vinh', 'Affiliation': 'Cardiovascular Center, Tam Anh hospital, Tan Tao University, Vietnam.'}, {'ForeName': 'Ulrica', 'Initials': 'U', 'LastName': 'Wilderäng', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Zaozerska', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lindholm', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Petersson', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'University of Glasgow, Glasgow, Scotland, UK.'}]",JACC. Heart failure,['10.1016/j.jchf.2021.11.006']
3371,35241243,NT-proBNP and ICD in Nonischemic Systolic Heart Failure: Extended Follow-Up of the DANISH Trial.,"OBJECTIVES


In this extended follow-up study of the DANISH (Danish Study to Assess the Efficacy of Implantable Cardioverter Defibrillators in Patients with Non-ischemic Systolic Heart Failure on Mortality) trial, adding 4 years of additional follow-up, we examined the effect of implantable cardioverter-defibrillator (ICD) implantation according to baseline N-terminal pro-B-type natriuretic peptide (NT-proBNP) level.
BACKGROUND


In the DANISH trial, NT-proBNP level at baseline appeared to modify the response to ICD implantation.
METHODS


In the DANISH trial, 1,116 patients with nonischemic systolic HF were randomized to receive an ICD (N = 556) or usual clinical care (N = 550). Outcomes were analyzed according to NT-proBNP levels (below/above median) at baseline. The primary outcome was death from any cause.
RESULTS


All 1,116 patients in the DANISH trial had an available NT-proBNP measurement at baseline (median: 1,177 pg/mL; range: 200-22,918 pg/mL). There was a trend toward a reduction in all-cause death with ICD implantation, compared with usual clinical care, in patients with NT-proBNP levels lower than the median (HR: 0.75 [95% CI: 0.55-1.03]), but not in those with higher NT-proBNP levels (HR: 0.95 [95% CI: 0.74-1.21]) (P interaction  = 0.28). Similarly, ICD implantation significantly reduced the rate of cardiovascular (CV) and sudden cardiovascular death (SCD) in patients with NT-proBNP levels lower than the median (CV death, HR: 0.69 [95% CI: 0.47-1.00]; SCD, HR: 0.37 [95% CI: 0.19-0.75]), but not in those with higher levels (CV death, HR: 0.94 [95% CI: 0.70-1.25]; SCD, HR: 0.86 [95% CI: 0.49-1.51]) (P interaction  = 0.20 and 0.08 for CV death and SCD, respectively).
CONCLUSIONS


Lower baseline NT-proBNP levels could identify patients with nonischemic systolic HF who may derive benefit from ICD implantation. (Danish Study to Assess the Efficacy of Implantable Cardioverter Defibrillators in Patients with Non-ischemic Systolic Heart Failure on Mortality [DANISH]; NCT00542945).",2022,"There was a trend toward a reduction in all-cause death with ICD implantation, compared with usual clinical care, in patients with NT-proBNP levels lower than the median (HR: 0.75 [95% CI: 0.55-1.03]), but not in those with higher NT-proBNP levels (HR: 0.95","['Nonischemic Systolic Heart\xa0Failure', 'All 1,116 patients in the DANISH trial had an available NT-proBNP measurement at baseline (median: 1,177 pg/mL; range: 200-22,918 pg/mL', 'Patients with Non-ischemic Systolic Heart\xa0Failure on Mortality', '1,116 patients with nonischemic systolic HF', 'Patients with Non-ischemic Systolic Heart Failure on Mortality [DANISH']","['ICD (N\xa0=\xa0556) or usual clinical care', 'implantable cardioverter-defibrillator (ICD) implantation', 'Implantable Cardioverter Defibrillators', 'NT-proBNP and ICD']","['death from any cause', 'NT-proBNP levels', 'rate of cardiovascular (CV) and sudden cardiovascular death (SCD']","[{'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C4517811', 'cui_str': '556'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1276802', 'cui_str': 'Sudden'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]",1116.0,0.556536,"There was a trend toward a reduction in all-cause death with ICD implantation, compared with usual clinical care, in patients with NT-proBNP levels lower than the median (HR: 0.75 [95% CI: 0.55-1.03]), but not in those with higher NT-proBNP levels (HR: 0.95","[{'ForeName': 'Jawad H', 'Initials': 'JH', 'LastName': 'Butt', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark. Electronic address: jawad_butt91@hotmail.com.'}, {'ForeName': 'Adelina', 'Initials': 'A', 'LastName': 'Yafasova', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Marie B', 'Initials': 'MB', 'LastName': 'Elming', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark; Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dixen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Haarbo', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Hellerup, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Svendborg, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Korup', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Niels E', 'Initials': 'NE', 'LastName': 'Bruun', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark; Department of Cardiology, Zealand University Hospital, Roskilde, Denmark; Department of Clinical Medicine, University of Aalborg, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eiskjær', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Brandes', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Cardiology, University Hospital of Southern Denmark, Esbjerg, Denmark.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Thøgersen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Egstrup', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Svendborg, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jesper Hastrup', 'Initials': 'JH', 'LastName': 'Svendsen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Dan E', 'Initials': 'DE', 'LastName': 'Høfsten', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Pehrson', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jens Jakob', 'Initials': 'JJ', 'LastName': 'Thune', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}]",JACC. Heart failure,['10.1016/j.jchf.2022.01.003']
3372,35242197,Effect of Combined Spinal-Epidural Anesthesia and Total Intravenous Anesthesia on Hemodynamics and Pregnancy Outcomes of Severe Preeclampsia Pregnant Patients Undergoing Cesarean Section.,"Objective


The purpose of the study was to investigate the effect of combined spinal-epidural anesthesia (CSEA) and total intravenous anesthesia (TIVA) on hemodynamics and pregnancy outcomes of severe preeclampsia pregnant patients undergoing cesarean section.
Methods


126 patients with severe preeclampsia admitted to Zhangqiu District People's Hospital from August 2018 to August 2019 were selected as the study subjects and randomly divided into the experimental group ( n  = 63) and control group ( n  = 63). After undergoing cesarean section, the patients in the experimental group received CSEA, while those in the control group were given TIVA. After that, the effect of different anesthesia methods on the hemodynamics and pregnancy outcomes of pregnant women was compared.
Results


There were no significant differences in age, BMI value, weight, height, gestational weeks, SBP, DBP, and residence between the two groups ( P  > 0.05). The operation duration, the onset time of anesthesia, and delivery time in the experimental group were significantly shorter than those in the control group, with less intraoperative blood loss in the experimental group than that in the control group ( P  < 0.001). In both groups, MAP and SpO 2  during delivery were significantly lower than those before anesthesia, and HR was significantly higher than that before anesthesia ( P  < 0.001). In the experimental group, MAP and HR during delivery were significantly lower than those in the control group, and SpO 2  was significantly higher than that in the control group ( P  < 0.001). The total effective rate of anesthesia in the experimental group was significantly higher than that in the control group ( P  < 0.05). The Apgar scoring of the newborns in the experimental group was significantly higher than that in the control group ( P  < 0.001), and the total incidence of postoperative adverse reactions in the experimental group was significantly lower than that in the control group ( P  < 0.05).
Conclusion


CSEA is a reliable anesthesia method for improving the hemodynamics indicators in pregnant patients with severe preeclampsia; such strategy greatly increases the Apgar score of newborns and shortens the anesthesia onset time. Further research will be conducive to establishing a better anesthesia plan for such patients.",2022,The total effective rate of anesthesia in the experimental group was significantly higher than that in the control group ( P  < 0.05).,"['pregnant women', 'Severe Preeclampsia Pregnant Patients Undergoing Cesarean Section', 'severe preeclampsia pregnant patients undergoing cesarean section', ""126 patients with severe preeclampsia admitted to Zhangqiu District People's Hospital from August 2018 to August 2019 were selected as the study subjects"", 'pregnant patients with severe preeclampsia']","['CSEA', 'Combined Spinal-Epidural Anesthesia and Total Intravenous Anesthesia', 'combined spinal-epidural anesthesia (CSEA) and total intravenous anesthesia (TIVA', 'TIVA']","['intraoperative blood loss', 'total effective rate of anesthesia', 'operation duration, the onset time of anesthesia, and delivery time', 'MAP and SpO 2  during delivery', 'Hemodynamics and Pregnancy Outcomes', 'hemodynamics and pregnancy outcomes', 'Apgar scoring of the newborns', 'age, BMI value, weight, height, gestational weeks, SBP, DBP, and residence', 'MAP and HR during delivery', 'total incidence of postoperative adverse reactions']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0341950', 'cui_str': 'Severe pre-eclampsia'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C1301668', 'cui_str': 'Time of delivery'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",126.0,0.0239328,The total effective rate of anesthesia in the experimental group was significantly higher than that in the control group ( P  < 0.05).,"[{'ForeName': 'Guangrong', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Operating Room of Anesthesiology, Zaozhuang Traditional Chinese Medicine Hospital, Beijing University of Chinese Medicine Zaozhuang Hospital, Beijing University of Chinese Medicine Fourth Clinical Medicine College, Zaozhuang 277000, Shandong, China.'}, {'ForeName': 'Pengyu', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""The Second Department of Internal Medicine-Neurology, Zhangqiu District People's Hospital, No. 1920 Mingshui Huiquan Road, Zhangqiu, Jinan 250200, Shandong, China.""}, {'ForeName': 'Minghui', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics, Taian Maternal and Child Health Hospital, Taian 271000, Shandong, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Outpatient, Taian Maternal and Child Health Hospital, Taian 271000, Shandong, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics, Zhangqiu District People's Hospital, Jinan 250200, Shandong, China.""}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2022/2655858']
3373,35242191,"Effect of an ""Autogenous Leukocyte Platelet-Rich Fibrin Tooth Graft"" Combination around Immediately Placed Implants in Periodontally Compromised Sites: A Randomized Clinical Trial.","Objective


Autogenous tooth bone graft (ATBG) was suggested as a source for bone grafting materials, especially as they have similar chemical composition to bone. This study goal was to assess the clinical and radiographic consequences of ATBG with or without L-PRF on bone deposition around immediate implants placed in periodontally hopeless sites.
Materials and Methods


26 patients, with periodontally diseased teeth, underwent random assignment to receive the surgical protocol either with L-PRF over ATBG around immediately inserted implants (test group) or without it (control group). Clinical examination was observed. Radiographically, bone changes horizontally and vertically to determine marginal bone loss (MBL) and mesiodistal bone changes were made at the base line and 6 and 9 months after implant insertion. Statistical analysis utilizing paired Student's  t -test was used for comparing results within the same group, whereas an independent-sample  t -test was used for intergroup variable comparison.
Results


All implants met the criteria of success without any complications at the follow-up period. Nonsignificant differences were detected between horizontal bone alterations in both groups at 6 and 9 months ( P  > .001). The test group showed statistically significant lower MBL than the control group ( P  < .001). The mesiodistal bone gain in the test group was significantly higher than that of the control group at the 6-month period ( P  < .001). The mesiodistal bone loss in the control group was significantly higher than that of the test group at the 9-month period ( P  < .001).
Conclusion


The ATBG- L-PRF combination therapy enhances new bone formation and appeared to be a favorable procedure with immediate implant placement, particularly in severe periodontitis cases.",2022,Nonsignificant differences were detected between horizontal bone alterations in both groups at 6 and 9 months ( P  > .001).,"['Periodontally Compromised Sites', '26 patients, with periodontally diseased teeth']","['Autogenous tooth bone graft (ATBG', 'ATBG with or without L-PRF', 'surgical protocol either with L-PRF over ATBG around immediately inserted implants (test group) or without it (control group', 'ATBG- L-PRF combination therapy', 'Autogenous Leukocyte Platelet-Rich Fibrin Tooth Graft"" Combination']","['mesiodistal bone gain', 'horizontal bone alterations', 'MBL', 'mesiodistal bone loss', 'marginal bone loss (MBL) and mesiodistal bone changes']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",26.0,0.0392117,Nonsignificant differences were detected between horizontal bone alterations in both groups at 6 and 9 months ( P  > .001).,"[{'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'ElAmrousy', 'Affiliation': 'Department of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Kafrelsheikh University, Kafr El-sheikh, Egypt.'}, {'ForeName': 'Dalia Rasheed', 'Initials': 'DR', 'LastName': 'Issa', 'Affiliation': 'Department of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Kafrelsheikh University, Kafr El-sheikh, Egypt.'}]",International journal of dentistry,['10.1155/2022/4951455']
3374,35242186,Hyperthermic Intraperitoneal Chemotherapy plus Intravenous Chemotherapy of Paclitaxel with or without Sintilimab in Gastric Cancer: A Comparative Study.,"Objective


To compare the clinical efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) plus intravenous chemotherapy of paclitaxel with or without sintilimab in peritoneal metastasis of gastric cancer.
Methods


A total of 120 patients assessed for eligibility with peritoneal metastasis of gastric cancer treated in the oncology department of our hospital from January 2019 to June 2020 were recruited. They were concurrently randomly assigned in a 1 : 1 ratio to receive HIPEC plus sintilimab-paclitaxel intravenous chemotherapy (study group) or plus paclitaxel intravenous chemotherapy only (control group).
Results


The objective remission rate (ORR) of ascites in the study group was significantly higher than that in the control group. Subgroup analysis showed that an age ≤60 years or well-differentiated tumors were associated with better objective remission. After treatment, significantly higher Karnofsky Performance Status (KPS) scores were observed in the study group versus those of the control group. Adverse events reported were comparable between groups. The study group obtained longer 12-month progression-free survival (PFS) and overall survival (OS) than those of the control group.
Conclusion


On top of HIPEC, intravenous chemotherapy with sintilimab and paclitaxel constitute an effective alternative for patients with peritoneal metastasis of gastric cancer to enhance ascites remission, ameliorate the quality of life, and prolong survival, versus with paclitaxel alone.",2022,The objective remission rate (ORR) of ascites in the study group was significantly higher than that in the control group.,"['120 patients assessed for eligibility with peritoneal metastasis of gastric cancer treated in the oncology department of our hospital from January 2019 to June 2020 were recruited', 'patients with peritoneal metastasis of gastric cancer', 'peritoneal metastasis of gastric cancer', 'Gastric Cancer']","['Hyperthermic Intraperitoneal Chemotherapy plus Intravenous Chemotherapy of Paclitaxel with or without Sintilimab', 'hyperthermic intraperitoneal chemotherapy (HIPEC) plus intravenous chemotherapy of paclitaxel with or without sintilimab', 'HIPEC plus sintilimab-paclitaxel intravenous chemotherapy (study group) or plus paclitaxel intravenous chemotherapy only (control group', 'HIPEC, intravenous chemotherapy with sintilimab and paclitaxel']","['quality of life, and prolong survival', 'objective remission', 'Adverse events', 'Karnofsky Performance Status (KPS) scores', '12-month progression-free survival (PFS) and overall survival (OS', 'objective remission rate (ORR) of ascites']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant neoplasm of peritoneum'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0413365', 'cui_str': 'Intravenous chemotherapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4760864', 'cui_str': 'sintilimab'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}]",120.0,0.138434,The objective remission rate (ORR) of ascites in the study group was significantly higher than that in the control group.,"[{'ForeName': 'Zao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Cangzhou City Center Hospital, Cangzhou, Hebei Province, China.'}, {'ForeName': 'Mei-Ying', 'Initials': 'MY', 'LastName': 'Ning', 'Affiliation': 'Department of Pharmacy, Cangzhou City Center Hospital, Cangzhou, Hebei Province, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Department of Pharmacy, Cangzhou City Center Hospital, Cangzhou, Hebei Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Cangzhou City Center Hospital, Cangzhou, Hebei Province, China.'}, {'ForeName': 'Zhuang-Zhuang', 'Initials': 'ZZ', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Cangzhou City Center Hospital, Cangzhou, Hebei Province, China.'}]",Journal of oncology,['10.1155/2022/3054485']
3375,35242094,Comparing the Effects of Short-Term Liuzijue Exercise and Core Stability Training on Balance Function in Patients Recovering From Stroke: A Pilot Randomized Controlled Trial.,"Aims


Liuzijue Qigong (LQG) exercise is a traditional Chinese exercise method in which breathing and pronunciation are combined with movement guidance. Breathing is closely related to balance, and LQG, as a special breathing exercise, can be applied to balance dysfunction after stroke. The purpose of this study was to observe the clinical effects of short-term LQG exercise on balance function in patients recovering from stroke.
Methods


Stroke patients were randomly divided into an Intervention Group (IG) ( n  = 80) and a Control Group (CG) ( n  = 80). The IG received conventional rehabilitation training plus LQG and the CG received conventional rehabilitation training plus Core Stability Training (CST). All patients received treatment once a day, 5 times a week for 2 weeks. The primary outcome was Berg Balance Scale (BBS). Secondary outcome measures were static standing and sitting balance with eyes open and closed, Fugl-Meyer Assessment (FMA), Maximum Phonation Time (MPT), Modified Barthel Index (MBI) and diaphragm thickness and mobility during quiet breath (QB) and deep breath (DB).
Results


Compared with the CG, the IG showed significant improvement in the BBS (10.55 ± 3.78 vs. 9.06 ± 4.50,  P  = 0.039), MPT (5.41 ± 4.70 vs. 5.89 ± 5.24,  P  = 0.001), MBI (12.88 ± 6.45 vs. 10.00 ± 4.84,  P  = 0.003), diaphragmatic mobility during QB (0.54 ± 0.73 vs. 0.33 ± 0.40,  P  = 0.01) and diaphragmatic mobility during DB (0.99 ± 1.32 vs. 0.52 ± 0.77,  P  = 0.003), Cop trajectory in the standing position with eyes open (-108.34 ± 108.60 vs. -89.00 ± 140.11,  P  = 0.034) and Cop area in the standing positions with eyes open (-143.79 ± 431.55 vs. -93.29 ± 223.15,  P  = 0.015), Cop trajectory in the seating position with eyes open (-19.95 ± 23.35 vs. -12.83 ± 26.64,  P  = 0.001) and Cop area in the seating position with eyes open (-15.83 ± 9.61 vs. -11.29 ± 9.17,  P  = 0.002).
Conclusions


The short-term LQG combined with conventional rehabilitation training significantly improved the balance functions of stroke patients. It also improved static standing and sitting balance with the eyes open, diaphragm functions, maximum phonation time and the quality of daily life for stroke patients.
Clinical Trial Registration


http://www.chictr.org.cn/edit.aspx?pid=25313&htm=4, Identifier: ChiCTR1800014864.",2022,"diaphragmatic mobility during QB (0.54 ± 0.73 vs. 0.33 ± 0.40,  P  = 0.01) and diaphragmatic mobility during DB (0.99 ± 1.32 vs. 0.52 ± 0.77,  P  = 0.003), Cop trajectory in the standing position with eyes open (","['Patients', 'Recovering From Stroke', 'stroke patients', 'patients recovering from stroke', 'Methods\n\n\nStroke patients']","['Control Group (CG', 'LQG) exercise', 'conventional rehabilitation training plus Core Stability Training (CST', 'short-term LQG exercise', 'Liuzijue Qigong ', 'conventional rehabilitation training', 'Short-Term Liuzijue Exercise and Core Stability Training']","['diaphragmatic mobility', 'Balance Function', 'static standing and sitting balance with eyes open and closed, Fugl-Meyer Assessment (FMA), Maximum Phonation Time (MPT), Modified Barthel Index (MBI) and diaphragm thickness and mobility during quiet breath (QB) and deep breath (DB', 'diaphragm functions, maximum phonation time and the quality of daily life', 'BBS', 'balance function', 'balance functions', 'static standing and sitting balance', 'Berg Balance Scale (BBS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0516712', 'cui_str': 'Balancing when sitting'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0234778', 'cui_str': 'Maximum phonation time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}]",,0.0132406,"diaphragmatic mobility during QB (0.54 ± 0.73 vs. 0.33 ± 0.40,  P  = 0.01) and diaphragmatic mobility during DB (0.99 ± 1.32 vs. 0.52 ± 0.77,  P  = 0.003), Cop trajectory in the standing position with eyes open (","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'JianZhong', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Qiao', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Ni', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'ZhiJie', 'Initials': 'Z', 'LastName': 'Yong', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'ShanShan', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}]",Frontiers in neurology,['10.3389/fneur.2022.748754']
3376,35242882,The Effects of  C. lacerata  on Insulin Resistance in Type 2 Diabetes Patients.,"Background


Several experimental studies have suggested beneficial effects of  Ceriporia lacerata  on glucose metabolism. However, there has been no human study assessing the effects of  C. lacerata  on glucose metabolism. Therefore, we investigated whether  C. lacerata  improves glucose control and insulin resistance in type 2 diabetes patients.
Methods


Ninety patients diagnosed with type 2 diabetes (T2DM) for more than 6 months were enrolled. Subjects were randomly divided into placebo ( n  = 45) or  C. lacerata  ( n  = 45) groups and then assigned to take placebo or  C. lacerata  capsules (500 mg/capsule) for a 12-week intervention period. Biochemical markers, including fasting glucose, 2-hour postprandial plasma glucose, and lipid profile levels, as well as insulin, c-peptide, and Hba1c, were measured. Furthermore, insulin sensitivity indices, such as HOMA-IR, HOMA-beta, and QUICKI, were assessed before and after the 12-week administration.
Results


Eighty-four patients completed the study. There were no significant differences in fasting, postprandial glucose, HbA1c, or lipid parameters. HOMA-IR and QUICKI indices were improved at week 12 in the  C. lacerata  group, especially in subjects with HOMA-IR of 1.8 or more ( p  < 0.05). Fasting, postprandial c-peptide, and insulin levels decreased at week 12 in the  C. lacerata  group ( p  < 0.05). These significant differences were not observed in the placebo group.
Conclusion


Twelve-week administration of  C. lacerata  in T2DM patients resulted in significant improvement in insulin resistance, especially in those with lower insulin sensitivity. A larger population study with a longer follow-up period and an effort to elucidate the mechanism is warranted to further assess the effects of  C. lacerata  on T2DM patients.",2022,"HOMA-IR and QUICKI indices were improved at week 12 in the  C. lacerata  group, especially in subjects with HOMA-IR of 1.8 or more ( p  < 0.05).","['type 2 diabetes patients', 'Type 2 Diabetes Patients', 'T2DM patients', 'Ninety patients diagnosed with type 2 diabetes (T2DM) for more than 6 months were enrolled']","['placebo or  C. lacerata  capsules', 'placebo', 'C. lacerata']","['fasting, postprandial glucose, HbA1c, or lipid parameters', 'Biochemical markers, including fasting glucose, 2-hour postprandial plasma glucose, and lipid profile levels, as well as insulin, c-peptide, and Hba1c', 'HOMA-IR and QUICKI indices', 'Fasting, postprandial c-peptide, and insulin levels', 'Furthermore, insulin sensitivity indices, such as HOMA-IR, HOMA-beta, and QUICKI', 'Insulin Resistance', 'insulin resistance', 'glucose control and insulin resistance']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",90.0,0.0521165,"HOMA-IR and QUICKI indices were improved at week 12 in the  C. lacerata  group, especially in subjects with HOMA-IR of 1.8 or more ( p  < 0.05).","[{'ForeName': 'Arim', 'Initials': 'A', 'LastName': 'Choi', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Republic of Korea.'}, {'ForeName': 'Jung Hye', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Republic of Korea.'}, {'ForeName': 'Hye-Kyung', 'Initials': 'HK', 'LastName': 'Chung', 'Affiliation': 'Severance Institute for Vascular and Metabolic Research, Yonsei University College of Medicine, Republic of Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Republic of Korea.'}, {'ForeName': 'Hee Joon', 'Initials': 'HJ', 'LastName': 'Choi', 'Affiliation': 'Gangnam Severance Hospital, Biochemical Research Center, Republic of Korea.'}, {'ForeName': 'Yu-Sik', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Republic of Korea.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Republic of Korea.'}]",Journal of diabetes research,['10.1155/2022/9537741']
3377,35242863,Validation of two risk assessment models for venous thromboembolism in patients undergoing gynecologic surgery.,"Background


According to published guidelines, gynecologic surgical patients should be stratified into different risk level groups to receive prophylaxis for venous thromboembolism (VTE), but the applicability of available risk assessment models (RAMs) in common gynecologic surgical patients remained to be confirmed. We aimed to validate the use of the Caprini RAM and gynecologic Caprini (G-Caprini) RAM for assessing postoperative VTE risk in gynecologic surgical patients.
Methods


The database of a randomized controlled trial (RCT) was used to select patients who underwent gynecologic surgeries for benignant and malignant diseases in five institutions in China between 2011 and 2018. The Caprini RAM version recommended by the American College of Chest Physicians (ACCP) was adopted. Participants were divided into four risk levels based on the Caprini and G-Caprini scores. For each risk level group, the incidence of VTE was calculated. The correlation between VET incidence and risk levels was assessed by Spearman's rank correlation coefficient (RS) value.
Results


As a result, 800 patients in the data base were analyzed with an overall VTE incidence of 5.8%. Caprini RAM showed that the percentage of patients at very low risk, low risk, moderate risk, and high risk were 0%, 4.3%, 44.4%, and 51.4%, respectively, and the VTE incidence was 2.9%, 2.3%, and 9.0%, respectively. RS value between the risk stratification and VTE incidence was 0.500 (P=0.667). G-Caprini RAM showed that the percentage of patients at very low risk, low risk, moderate risk, and high risk were 7.8%, 28.0%, 32.0%, and 32.3%, respectively, and the VTE incidence was 0.0%, 2.9%, 2.3%, and 9.0%, respectively. RS value between the risk stratification and VTE incidence was 1.000 (P<0.01).
Conclusions


The G-Caprini RAM was as suitable as the Caprini RAM for VTE risk assessment in gynecologic surgical patients. The gynecologic model has the advantages of ease of use and more accurate identification of low-risk groups.",2022,The G-Caprini RAM was as suitable as the Caprini RAM for VTE risk assessment in gynecologic surgical patients.,"['common gynecologic surgical patients', 'patients undergoing gynecologic surgery', 'gynecologic surgical patients', 'patients who underwent gynecologic surgeries for benignant and malignant diseases in five institutions in China between 2011 and 2018']","['Caprini RAM', 'RAM', 'G-Caprini RAM', 'Caprini RAM and gynecologic Caprini']","['overall VTE incidence', 'VTE incidence', 'VET incidence and risk levels']","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0526951', 'cui_str': 'ramosetron hydrochloride'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242856', 'cui_str': 'Veterinarian'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0706701,The G-Caprini RAM was as suitable as the Caprini RAM for VTE risk assessment in gynecologic surgical patients.,"[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Cui-Qin', 'Initials': 'CQ', 'LastName': 'Sang', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhen-Yu', 'Initials': 'ZY', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ruijun', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Department of Ultrasonography, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ruigang', 'Initials': 'R', 'LastName': 'Lu', 'Affiliation': 'Department of Ultrasonography, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Qu', 'Affiliation': 'Department of Ultrasonography, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Department of Ultrasonography, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Ultrasonography, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jian-Liu', 'Initials': 'JL', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Zhai', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Obstetrics and Gynecology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Zhi-Qiang', 'Initials': 'ZQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}]",Annals of translational medicine,['10.21037/atm-21-6284']
3378,35242808,Major Risk Factors Analysis of Pruritus Complicated by Type 2 Diabetes Mellitus and the Effect of Comprehensive Nursing Intervention.,"Objective


To observe the main risk factors for pruritic skin evidence complicating type 2 diabetes mellitus (T2DM) and the effectiveness of interventions with comprehensive care measures.
Methods


Two hundred and twenty four patients with T2DM admitted to our hospital from June 2020 to November 2021 were selected and divided into Diabetic pruritus group (DP group,  n  = 71) and T2DM group ( n  = 153) according to the patients' complications of pruritus. General information such as gender, age, body mass index (BMI), duration of illness, family history, treatment modalities, other comorbidities, underlying illnesses were collected from all patients. Fasting plasma glucose (FPG), renal function [Serum creatinine (Scr), urea nitrogen (BUN), uric acid (BUA)], lipid levels [total cholesterol (TC), triacylglycerol (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)] were measured in all patients on day 2 after admission. Risk factors for pruritus complicating T2DM were identified by single multifactorial analysis. Meanwhile, patients in the DP group were divided into group A ( n  = 35) and group B ( n  = 36) using the random number table method. Group A adopted the conventional care mode and group B patients adopted the comprehensive care interventions to compare the care effects [visual analog score (VAS) before and after care, treatment efficiency, care satisfaction rate] of patients in groups A and B; the levels of pruritus mediator indicators [substance P,β-endorphin (β-EP) and γ-interferon (INF-γ)] before and after care.
Results


Risk factors for pruritus in T2DM were age, duration of DM, combined Diabetic peripheral neuropathy (DPN), combined diabetic retinopathy (DR), combined diabetic kidney disease (DKD) and serum FPG levels ( P  <0.05). Satisfaction rate of nursing care, treatment efficiency, post-care improvement in VAS scores, serum substance P, β-EP and INF-γ levels and other mediators of pruritus were better in Group B with integrated nursing intervention than in group A with conventional care only ( P  < 0.05).
Conclusion


Pruritus in T2DM is associated with age, duration of DM, combined DPN, combined DR, combined DKD and FPG levels. Comprehensive care according to the above risk factors can effectively relieve patients' clinical symptoms and signs, improve the level of pruritus mediators and patient-care relationship.",2022,"Satisfaction rate of nursing care, treatment efficiency, post-care improvement in VAS scores, serum substance P, β-EP and INF-γ levels and other mediators of pruritus were better in Group B with integrated nursing intervention than in group A with conventional care only ( P  < 0.05).
","['Two hundred and twenty four patients with T2DM admitted to our hospital from June 2020 to November 2021 were selected and divided into Diabetic pruritus group (DP group,  n  = 71) and', 'pruritic skin evidence complicating type 2 diabetes mellitus (T2DM']","['Comprehensive Nursing Intervention', 'T2DM', 'conventional care mode and group B patients adopted the comprehensive care interventions', 'integrated nursing intervention']","['duration of DM, combined Diabetic peripheral neuropathy (DPN), combined diabetic retinopathy (DR), combined diabetic kidney disease (DKD) and serum FPG levels', 'Fasting plasma glucose (FPG), renal function [Serum creatinine (Scr), urea nitrogen (BUN), uric acid (BUA)], lipid levels [total cholesterol (TC), triacylglycerol (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C', 'levels of pruritus mediator indicators [substance P,β-endorphin (β-EP) and γ-interferon (INF-γ', 'Satisfaction rate of nursing care, treatment efficiency, post-care improvement in VAS scores, serum substance P, β-EP and INF-γ levels and other mediators of pruritus']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0014242', 'cui_str': 'Endorphin'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}]",224.0,0.00458627,"Satisfaction rate of nursing care, treatment efficiency, post-care improvement in VAS scores, serum substance P, β-EP and INF-γ levels and other mediators of pruritus were better in Group B with integrated nursing intervention than in group A with conventional care only ( P  < 0.05).
","[{'ForeName': 'Qiu Ping', 'Initials': 'QP', 'LastName': 'Yang', 'Affiliation': 'Endocrinology Ward, Shenzhen Traditional Chinese Medicine Hospital (The Fourth Clinical Medical School of Guangzhou University of Chinese Medicine), Shenzhen, China.'}, {'ForeName': 'Yuan Yuan', 'Initials': 'YY', 'LastName': 'Chen', 'Affiliation': 'Nursing Department, Shenzhen Traditional Chinese Medicine Hospital (The Fourth Clinical Medical School of Guangzhou University of Chinese Medicine), Shenzhen, China.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Surgery Ward 3-4, Shenzhen Traditional Chinese Medicine Hospital (The Fourth Clinical Medical School of Guangzhou University of Chinese Medicine), Shenzhen, China.'}, {'ForeName': 'Mingming', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Nursing Department, Shenzhen Traditional Chinese Medicine Hospital (The Fourth Clinical Medical School of Guangzhou University of Chinese Medicine), Shenzhen, China.'}]",Frontiers in surgery,['10.3389/fsurg.2022.842884']
3379,35245225,"Success and Time to Oxygen Delivery for Scalpel-Finger-Cannula and Scalpel-Finger-Bougie Front-of-Neck Access: A Randomized Crossover Study With a Simulated ""Can't Intubate, Can't Oxygenate"" Scenario in a Manikin Model With Impalpable Neck Anatomy.","BACKGROUND


Emergency front-of-neck access (FONA) is particularly challenging with impalpable neck anatomy. We compared 2 techniques that are based on a vertical midline neck incision, followed by finger dissection and then either a cannula or scalpel puncture to the cricothyroid membrane.
METHODS


A manikin simulation scenario of impalpable neck anatomy and bleeding was created. Sixty-five anesthesiologists undergoing cricothyrotomy training performed scalpel-finger-cannula (SFC) and scalpel-finger-bougie (SFB) cricothyrotomy in random order. Primary outcomes were time to oxygen delivery and first-attempt success; data were analyzed using multilevel mixed-effects models.
RESULTS


SFC was associated with a shorter time to oxygen delivery on univariate (median time difference, -61.5 s; 95% confidence interval [CI], -84.7 to -38.3; P < .001) and multivariable (mean time difference, -62.1 s; 95% CI, -83.2 to -41.0; P < .001) analyses. Higher first-attempt success was reported with SFC than SFB (47 of 65 [72.3%] vs 18 of 65 [27.7%]). Participants also had higher odds at achieving first-attempt success with SFC than SFB (odds ratio [OR], 10.7; 95% CI, 3.3-35.0; P < .001). Successful delivery of oxygen after the ""can't intubate, can't oxygenate"" (CICO) declaration within 3 attempts and 180 seconds was higher (84.6% vs 63.1%) and more likely with SFC (OR, 5.59; 95% CI, 1.7-18.9; P = .006). Analyzing successful cases only, SFC achieved a shorter time to oxygen delivery (mean time difference, -24.9 s; 95% CI, -37.8 to -12.0; P < .001), but a longer time to cuffed tube insertion (mean time difference, +56.0 s; 95% CI, 39.0-73.0; P < .001). After simulation training, most participants preferred SFC in patients with impalpable neck anatomy (75.3% vs 24.6%).
CONCLUSIONS


In a manikin simulation of impalpable neck anatomy and bleeding, the SFC approach demonstrated superior performance in oxygen delivery and was also the preferred technique of the majority of study participants. Our study findings support the use of a cannula-based FONA technique for achieving oxygenation in a CICO situation, with the prerequisite that appropriate training and equipment are available.",2022,"SFC was associated with a shorter time to oxygen delivery on univariate (median time difference, -61.5 s;",['Sixty-five anesthesiologists undergoing'],"['cricothyrotomy training performed scalpel-finger-cannula (SFC) and scalpel-finger-bougie (SFB) cricothyrotomy', 'Scalpel-Finger-Cannula and Scalpel-Finger-Bougie Front-of-Neck Access', 'cannula-based FONA technique']","['Success and Time to Oxygen Delivery', 'shorter time to oxygen delivery', 'longer time to cuffed tube insertion', 'time to oxygen delivery and first-attempt success; data']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0392220', 'cui_str': 'Scalpel'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0179390', 'cui_str': 'Bougie'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",65.0,0.234789,"SFC was associated with a shorter time to oxygen delivery on univariate (median time difference, -61.5 s;","[{'ForeName': 'Jinbin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Anaesthesiology, Intensive Care and Pain Medicine, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Shimin', 'Initials': 'S', 'LastName': 'Ong', 'Affiliation': 'From the Department of Anaesthesiology, Intensive Care and Pain Medicine, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Toh', 'Affiliation': 'Department of Anaesthesia, Woodlands Health, Singapore.'}, {'ForeName': 'Meifang', 'Initials': 'M', 'LastName': 'Chew', 'Affiliation': 'From the Department of Anaesthesiology, Intensive Care and Pain Medicine, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Ang', 'Affiliation': 'From the Department of Anaesthesiology, Intensive Care and Pain Medicine, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Goh', 'Affiliation': 'From the Department of Anaesthesiology, Intensive Care and Pain Medicine, Tan Tock Seng Hospital, Singapore.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005969']
3380,35245224,Continuous Titration of Inspired Oxygen Using Oxygen Reserve Index to Decrease Oxygen Exposure During One-Lung Ventilation: A Randomized Controlled Trial.,"BACKGROUND


A high fraction of inspired oxygen (Fio2) is administered during one-lung ventilation (OLV). However, a high Fio2 is not physiologic and may lead to various complications. We hypothesized that continuous titration of Fio2 using the oxygen reserve index (ORI) reduces oxygen exposure compared to conventional management during OLV.
METHODS


In this randomized, double-blinded trial, patients undergoing thoracic surgery were assigned to an ORI (n = 64) or a control group (n = 60). In the ORI group, ORI was continuously displayed using multiwavelength pulse co-oximetry (Masimo) between 0 and 1 (0, no reserve; 1, maximum reserve), and Fio2 was titrated for a target ORI of 0.21 at 5-minute intervals during OLV. In the control group, Fio2 was adjusted using arterial blood gas analysis measured at 15 minutes after OLV initiation. The primary end point was the time-weighted average Fio2 during OLV.
RESULTS


Overall, time-weighted average Fio2 did not differ between the groups (control versus ORI: median [interquartile range], 0.87 [0.73-1.00] vs 0.82 [0.68-0.93]; P = .09). However, in a subgroup analysis, the ORI group reduced time-weighted average Fio2 after pulmonary vascular ligation compared to the control group (control versus ORI: median [interquartile range], 0.75 [0.70-1.00] vs 0.72 [0.59-0.89]; P = .0261). The incidence of intraoperative hypoxia (arterial oxygen saturation [Spo2] <94%; control versus ORI: 32% [19/60; 95% confidence interval (CI), 20-45] vs 19% [12/64; 95% CI, 10-31]; P = .09), and postoperative complications within the first 7 days did not differ between the groups.
CONCLUSIONS


ORI-guided continuous Fio2 titration does not reduce overall oxygen exposure during OLV.",2022,"The incidence of intraoperative hypoxia (arterial oxygen saturation [Spo2] <94%; control versus ORI: 32% [19/60; 95% confidence interval (CI), 20-45] vs 19% [12/64; 95% CI, 10-31]; P = .09), and postoperative complications within the first 7 days did not differ between the groups.
","['During One-Lung Ventilation', 'patients undergoing thoracic surgery']","['ORI', 'Continuous Titration of Inspired Oxygen Using Oxygen Reserve Index to Decrease Oxygen Exposure']","['overall oxygen exposure', 'Overall, time-weighted average Fio2', 'time-weighted average Fio2 after pulmonary vascular ligation', 'postoperative complications', 'ORI', 'time-weighted average Fio2 during OLV', 'incidence of intraoperative hypoxia (arterial oxygen saturation [Spo2']","[{'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}]",,0.568934,"The incidence of intraoperative hypoxia (arterial oxygen saturation [Spo2] <94%; control versus ORI: 32% [19/60; 95% confidence interval (CI), 20-45] vs 19% [12/64; 95% CI, 10-31]; P = .09), and postoperative complications within the first 7 days did not differ between the groups.
","[{'ForeName': 'Mikyung', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'From the Departments of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Jie Ae', 'Initials': 'JA', 'LastName': 'Kim', 'Affiliation': 'From the Departments of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Hyun Joo', 'Initials': 'HJ', 'LastName': 'Ahn', 'Affiliation': 'From the Departments of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Young Soo', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'MiHye', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'From the Departments of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Heejoon', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': 'From the Departments of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Keoungah', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, School of Dentistry, Dankook University, Cheon-an, South Korea.'}, {'ForeName': 'Nam Young', 'Initials': 'NY', 'LastName': 'Lee', 'Affiliation': 'From the Departments of Anesthesiology and Pain Medicine.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005967']
3381,35245672,Disinfection of implant abutment connection using antimicrobial photodynamic therapy and 0.2% chlorhexidine gel applications immediately before prosthesis delivery: clinical and radiographic status at 1-year of follow-up.,"OBJECTIVE


The aim of this 1-year follow-up randomized control trial was to compare the clinicoradiographic status of implants that were disinfected with antimicrobial photodynamic therapy (aPDT) and 0.2% chlorhexidine gel immediately before prosthesis delivery.
METHODS


Forty-five partially edentulous patients with implants placed in the region of missing mandibular first molars and a history of periodontal diseases were included. Immediately before prosthesis delivery, patients were divided into three groups. In groups 1 and 2, implant abutment disinfection (IAD) was performed using aPDT and 0.2% chlorhexidine immediately before prosthesis delivery. In Group-3, IAD was performed using a steaming protocol. Peri-implant modified plaque index (mPI), modified gingival index (mGI), probing depth (PD) and crestal bone loss (CBL) were assessed at 1 year of follow-up. Power analysis was done and group comparisons were done. Logistic regression analysis was done to corelate clinical parameters with demographic variables. P<0.01 was considered statistically significant.
RESULTS


In total, 15, 15, and 15 implants were present among patients in groups 1, 2 and 3, respectively. There was no statistically significant difference in peri-implant mPI, mBoP, PD and CBL in all groups (Table 2). None of the patients had periodontal disease and there was no statistically significant correlation between peri-implant clinicoradiographic parameters with age, toothbrushing and flossing habits, and duration of implants in function. Eighty percent, 86.7% and 100% individuals in groups 1, 2 and 3, respectively reported that they were brushing teeth twice daily. Flossing of interproximal spaces once daily was reported by 66.7%, 73.3% and 66.7% individuals in groups 1, 2 and 3, respectively.
CONCLUSION


As long as oral hygiene is stringently maintained after implant prosthesis delivery, IAD can be performed using aPDT, 0.2% CHX gel or steam-disinfection.",2022,"Peri-implant modified plaque index (mPI), modified gingival index (mGI), probing depth (PD) and crestal bone loss (CBL) were assessed at 1 year of follow-up.",['Forty-five partially edentulous patients with implants placed in the region of missing mandibular first molars and a history of periodontal diseases were included'],"['antimicrobial photodynamic therapy (aPDT) and 0.2% chlorhexidine gel', 'antimicrobial photodynamic therapy and 0.2% chlorhexidine gel', 'implant abutment disinfection (IAD', 'aPDT and 0.2% chlorhexidine']","['Peri-implant modified plaque index (mPI), modified gingival index (mGI), probing depth (PD) and crestal bone loss (CBL', 'peri-implant mPI, mBoP, PD and CBL']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",,0.015519,"Peri-implant modified plaque index (mPI), modified gingival index (mGI), probing depth (PD) and crestal bone loss (CBL) were assessed at 1 year of follow-up.","[{'ForeName': 'Bandar', 'Initials': 'B', 'LastName': 'Alresheedi', 'Affiliation': 'Department of Prosthodontics, College of Dentistry, Qassim University, Qassim, Saudi Arabia. Electronic address: B.alresheedi@qu.edu.sa.'}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Alazmi', 'Affiliation': 'Department of Periodontology, College of Dentistry, Qassim University, Qassim, Saudi Arabia.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2022.102790']
3382,35245661,Effect of allopurinol drug use on GFR and proteinuria in patients with renal transplant recipients (ADOPTR study).,"BACKGROUND


Hyperuricemia has been associated with the development of hypertension, cardiovascular, and renal disease. However, there is no data about the effect of lowering uric acid level on renal functions and proteinuria in renal transplant recipients. This study aimed to investigate the effect of allopurinol treatment on renal functions in renal transplant recipients (RTR).
METHODS


A total of 245 patients with renal transplantation were included in this randomized, placebo-controlled study. Patients were randomized to receive either placebo (121 patients) or 300 mg/day allopurinol (124 patients). We have examined uric acid, urinary protein creatinin ratio, MDRD (the modification of diet in renal diseases) and CRP (C-reactive protein) before and 24 weeks after treatment in both group.
RESULTS


In the allopurinol group, the mean serum uric acid levels, eGFR (estimated glomerular filtration rate), and creatinine urinary albumin creatinin ratio (UACR) significantly improved (p < 0.001). Also uric acid level was positively correlated with the UACR (r = 0,645 p < 0.001) and negatively correlated with MDRD (r = -0,387 p < 0.05) in allopurinol treatment group. A statistically significant increase in CRP level was observed (p < 0,05) in plasebo group. Multivariate regression analysis showed that uric acid was positively correlated with UACR (r = 0,473, β = 0.021, p = 0.002) and negatively correlated with MDRD (r = -0554 β = 0.016, P = 0.001) in allopurinol treatment RTR.
CONCLUSION


Urate, a salt of uric acid, is lowered by allopurinol treatment resulting in improved eGFR and decreased proteinuria, when compared to the placebo group. Therefore, we suggest that allopurinol therapy should be part of the management of kidney transplant patients with normal kidney function. Long-term follow-up studies will be useful in revealing the effect of uric acid management on kidney functions and proteinuria.",2022,"A statistically significant increase in CRP level was observed (p < 0,05) in plasebo group.","['kidney transplant patients with normal kidney function', 'patients with renal transplant recipients (ADOPTR study', '245 patients with renal transplantation', 'renal transplant recipients', 'renal transplant recipients (RTR']","['allopurinol therapy', 'allopurinol', 'placebo']","['uric acid, urinary protein creatinin ratio, MDRD', 'GFR and proteinuria', 'uric acid level', 'uric acid', 'renal functions', 'CRP level', 'MDRD', 'mean serum uric acid levels, eGFR (estimated glomerular filtration rate), and creatinine urinary albumin creatinin ratio (UACR']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517661', 'cui_str': '245'}]","[{'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3839656', 'cui_str': 'Modification of diet in renal disease formula'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0001924', 'cui_str': 'albumin'}]",245.0,0.0209856,"A statistically significant increase in CRP level was observed (p < 0,05) in plasebo group.","[{'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Usalan', 'Affiliation': 'Gaziantep University School of Medicine, Department of Nephrology, Gaziantep, Turkey.'}, {'ForeName': 'Ahmet Ziya', 'Initials': 'AZ', 'LastName': 'Şahin', 'Affiliation': 'Gaziantep University School of Medicine, Department of Nephrology, Gaziantep, Turkey. Electronic address: drahmetziya@hotmail.com.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Özdemir', 'Affiliation': 'Gaziantep University School of Medicine, Department of Nephrology, Gaziantep, Turkey.'}, {'ForeName': 'Mukaddes', 'Initials': 'M', 'LastName': 'Cingöz', 'Affiliation': 'Şehitkamil State Hospital, Department of Internal Medicine, Gaziantep, Turkey.'}, {'ForeName': 'Celalettin', 'Initials': 'C', 'LastName': 'Usalan', 'Affiliation': 'Gaziantep University School of Medicine, Department of Nephrology, Gaziantep, Turkey.'}]",Transplant immunology,['10.1016/j.trim.2022.101560']
3383,35245645,Educational interventions and animal consumption: Results from lab and field studies.,"Currently, there are many advocacy interventions aimed at reducing animal consumption. We report results from a lab (N = 267) and a field experiment (N = 208) exploring whether, and to what extent, some of those educational interventions are effective at shifting attitudes and behavior related to animal consumption. In the lab experiment, participants were randomly assigned to read a philosophical ethics paper, watch an animal advocacy video, read an advocacy pamphlet, or watch a control video. In the field experiment, we measured the impact of college classes with animal ethics content versus college classes without animal ethics content. Using a pretest, post-test matched control group design, humane educational interventions generally made people more knowledgeable about animals used as food and reduced justifications and speciesist attitudes supporting animal consumption. None of the interventions in either experiment had a direct, measurable impact on self-reported animal consumption. These results suggest that while some educational interventions can change beliefs and attitudes about animal consumption, those same interventions have small impacts on animal consumption.",2022,"None of the interventions in either experiment had a direct, measurable impact on self-reported animal consumption.",[],"['Educational interventions and animal consumption', 'philosophical ethics paper, watch an animal advocacy video, read an advocacy pamphlet, or watch a control video', 'humane educational interventions generally made people more knowledgeable about animals used as food and reduced justifications and speciesist attitudes supporting animal consumption']",[],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0150446', 'cui_str': 'Advocacy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1998726', 'cui_str': 'Is informed'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",[],,0.0699148,"None of the interventions in either experiment had a direct, measurable impact on self-reported animal consumption.","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Feltz', 'Affiliation': 'University of Oklahoma, United States; Center for Applied Social Research, University of Oklahoma, United States. Electronic address: afeltz@ou.edu.'}, {'ForeName': 'Jacob N', 'Initials': 'JN', 'LastName': 'Caton', 'Affiliation': 'Arkansas State University, United States.'}, {'ForeName': 'Zac', 'Initials': 'Z', 'LastName': 'Cogley', 'Affiliation': 'Balto Software, United States.'}, {'ForeName': 'Mylan', 'Initials': 'M', 'LastName': 'Engel', 'Affiliation': 'Northern Illinois University, United States.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Feltz', 'Affiliation': 'University of Oklahoma, United States.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Ilea', 'Affiliation': 'Pacific University, United States.'}, {'ForeName': 'L Syd M', 'Initials': 'LSM', 'LastName': 'Johnson', 'Affiliation': 'Center for Bioethics and Humanities, Upstate Medical University, United States.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Offer-Westort', 'Affiliation': 'University of Oklahoma, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Tuvel', 'Affiliation': 'Rhodes College, United States.'}]",Appetite,['10.1016/j.appet.2022.105981']
3384,35245642,A pilot study examining the impact of a brief health education intervention on food choices and exercise in a Latinx college student sample.,"Healthy eating and physical activity (PA) necessitate interventions designed to increase these behaviors. Self-Determination Theory (SDT) posits addressing psychological needs to promote intrinsic motivation, while the Transtheoretical Model (TTM) posits progression through stages of change consistent with contemplating processes of change. Previous findings suggest the efficacy of combining these approaches to understand, initiate, and maintain behavior. This study assessed a pilot intervention to increase healthy eating and PA based on components derived from SDT and TTM. Latinx college students (N = 267) were randomized to either the Fit U intervention or the self-monitoring only group. The Fit U intervention augmented self-monitoring with personalized, culturally-tailored motivational enhancement feedback and goal setting. Inferential analyses used hierarchical regression models to predict total calorie intake, fruit and vegetable (FV) intake, eating behavior, PA, and perceived competence for diet and exercise. Logistic regression models were used to examine changes in motivation to engage in a healthy diet and PA at post-test. Findings suggest those in Fit U reported lower calorie intake (β = 0.143, p = .023), improvement in healthy eating (β = -0.157, p < .001), increased perceived competence for diet (β = -0.145, p = .007) and exercise (β = -0.167, p = .003), and progression through the stages of change for exercise (OR = 0.297, p = .003). Findings suggest the efficacy of personalized, culturally-tailored motivational enhancement and goal setting beyond simply self-monitoring on healthy eating and PA outcomes in Latinx college students. Future directions include assessing the impact of Fit U on a larger scale and including long term follow-up assessments to assess the sustainability of eating and PA changes and their impact on superordinate outcomes such as weight loss.",2022,"Findings suggest those in Fit U reported lower calorie intake (β = 0.143, p = .023), improvement in healthy eating (β = -0.157, p < .001), increased perceived competence for diet (β = -0.145, p = .007) and exercise (β = -0.167, p = .003), and progression through the stages of change for exercise (OR = 0.297, p = .003).","['Latinx college students', 'Latinx college student sample', 'Latinx college students (N\u202f=\u202f267']","['Self-Determination Theory (SDT', 'Fit U intervention or the self-monitoring only group', 'health education intervention']","['healthy eating and PA', 'total calorie intake, fruit and vegetable (FV) intake, eating behavior, PA, and perceived competence for diet and exercise', 'healthy eating and PA outcomes', 'calorie intake', 'healthy eating']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517672', 'cui_str': '267'}]","[{'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",267.0,0.00593577,"Findings suggest those in Fit U reported lower calorie intake (β = 0.143, p = .023), improvement in healthy eating (β = -0.157, p < .001), increased perceived competence for diet (β = -0.145, p = .007) and exercise (β = -0.167, p = .003), and progression through the stages of change for exercise (OR = 0.297, p = .003).","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Blow', 'Affiliation': 'Texas Tech University Health Sciences Center El Paso, 5001 El Paso Drive, El Paso, TX, 79905, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sagaribay', 'Affiliation': 'The University of Texas at El Paso, 500 West University Avenue, El Paso, TX, 79968, USA.'}, {'ForeName': 'Theodore V', 'Initials': 'TV', 'LastName': 'Cooper', 'Affiliation': 'The University of Texas at El Paso, 500 West University Avenue, El Paso, TX, 79968, USA. Electronic address: tvcooper@utep.edu.'}]",Appetite,['10.1016/j.appet.2022.105979']
3385,35245626,Cost-effectiveness of AI for Caries Detection: Randomized Trial.,"OBJECTIVES


We assessed the cost-effectiveness of AI-supported detection of proximal caries in a randomized controlled clustered cross-over superiority trial.
METHODS


Twenty-three dentists were sampled to assess 20 bitewings; 10 were randomly evaluated supported by an AI-based software (dentalXrai Pro 1.0.4, dentalXrai Ltd, Berlin, Germany) and the other 10 without AI support. The reference test had been established by four independent experts and an additional review. We evaluated the proportion of true and false positive and negative detections and the treatment decisions assigned to each detection (non-invasive, micro-invasive, invasive). Cost-effectiveness was assessed using a mixed public-private-payer perspective in German healthcare. Using the accuracy and treatment decision data from the trial, a Markov simulation model was populated and posterior permanent teeth in initially 31-years old individuals followed over their lifetime. The model allowed extrapolation from the initial detection and therapy to treatment success, re-treatments and, eventually, tooth loss and replacement, capturing long-term effectiveness (tooth retention) and costs (cumulative in Euro). Costs were estimated using the German public and private fee catalogues. Monte-Carlo microsimulations were used and incremental cost-effectiveness at different willingness-to-pay ceiling thresholds assessed.
RESULTS


In the trial, AI-supported detection was significantly more sensitive than detection without AI. However, in the AI group, lesions were more often treated invasively. As a result, AI and no AI showed identical effectiveness (tooth retention for a mean (2.5-97.5%) 49 (48-51)) and nearly identical costs (AI: 330 (250-409) Euro, no AI: 330 (248-410) Euro). 41% simulations found AI and 43% no AI to be more cost-effective. The resulting cost-effectiveness remained uncertain regardless of a payer's willingness-to-pay.
CONCLUSIONS


Higher accuracy of AI did not lead to higher cost-effectiveness, as more invasive treatment approaches generated costs and diminished possible effectiveness advantages.
CLINICAL SIGNIFICANCE


The cost-effectiveness of AI could be improved by supporting not only caries detection, but also subsequent management.",2022,"Higher accuracy of AI did not lead to higher cost-effectiveness, as more invasive treatment approaches generated costs and diminished possible effectiveness advantages.
",['Twenty-three dentists were sampled to assess 20 bitewings; 10 were randomly evaluated supported by an'],"['AI-based software (dentalXrai\xa0Pro 1.0.4, dentalXrai Ltd, Berlin, Germany) and the other 10 without AI support']","['cost-effectiveness', 'Cost-effectiveness', 'tooth loss and replacement, capturing long-term effectiveness (tooth retention) and costs (cumulative in Euro', 'proportion of true and false positive and negative detections', 'cost-effective']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C1136140', 'cui_str': 'Long-Term Depression, Neurophysiologic'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",23.0,0.0249177,"Higher accuracy of AI did not lead to higher cost-effectiveness, as more invasive treatment approaches generated costs and diminished possible effectiveness advantages.
","[{'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Schwendicke', 'Affiliation': 'Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, Germany. Electronic address: falk.schwendicke@charite.de.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mertens', 'Affiliation': 'Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Anselmo Garcia', 'Initials': 'AG', 'LastName': 'Cantu', 'Affiliation': 'Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Akhilanand', 'Initials': 'A', 'LastName': 'Chaurasia', 'Affiliation': ""Faculty of Dental Sciences, King George's Medical University,India.""}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Meyer-Lueckel', 'Affiliation': 'Operative, Preventive and Paediatric Dentistry, zmk Bern, Switzerland.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Krois', 'Affiliation': 'Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, Germany.'}]",Journal of dentistry,['10.1016/j.jdent.2022.104080']
3386,35245946,Adjunctive Membrane Sweeping in Foley Catheter Induction of Labor After One Previous Cesarean Delivery: A Randomized Trial.,"OBJECTIVE


To evaluate adjunctive membrane sweeping in Foley catheter labor induction on induction to delivery interval and maternal satisfaction in women with one previous Cesarean.
METHODS


This randomized trial was conducted from June-December 2020. 63 term women with one previous Cesarean delivery, planned for labor induction with unripe cervixes (Bishop score≤5), singleton, cephalic presentation with intact membranes and reassuring pre-induction fetal heart rate tracing were recruited. Women were randomized to membrane sweeping or no sweeping prior to Foley catheter induction of labor. Primary outcomes were induction to delivery interval(hours) and maternal satisfaction with the birth process(assessed by Visual Numerical Rating Scale 0-10).
RESULTS


Induction to delivery intervals(hours) were mean±standard deviation 25.2±9.8 vs. 27.0±9.4, P=0.463 and maternal satisfaction on birth process were median[interquartile range] 8[7-8] vs.8[7-9], P=0.170, and, for adjunctive membrane sweeping with Foley catheter vs. Foley catheter arms respectively. Cesarean delivery rates were 22/32(69%) vs.19/31(61%) RR 1.12(0.78-1.62), P=0.603 and insertion to catheter removal interval, median[interquartile range] 15[6.3-21.0] vs.19[11.0-24.0] hours, P=0.065 for membrane sweeping with Foley catheter vs. Foley catheter arm respectively.
CONCLUSION


Membrane sweeping prior to Foley catheter labor induction in women with one previous Cesarean and unfavorable cervixes did not improve induction to delivery interval and maternal satisfaction.",2022,Cesarean delivery rates were 22/32(69%) vs.19/31(61%),"['63 term women with one previous Cesarean delivery, planned for labor induction with unripe cervixes (Bishop score≤5), singleton, cephalic presentation with intact membranes and reassuring pre-induction fetal heart rate tracing were recruited', 'Foley Catheter Induction of Labor', 'June-December 2020', 'women with one previous Cesarean']","['membrane sweeping or no sweeping prior to Foley catheter induction of labor', 'Membrane sweeping prior to Foley catheter labor induction']","['induction to delivery interval(hours) and maternal satisfaction with the birth process(assessed by Visual Numerical Rating Scale 0-10', 'induction to delivery interval and maternal satisfaction', 'Cesarean delivery rates']","[{'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0457226', 'cui_str': 'Uneffaced cervix'}, {'cui': 'C0649610', 'cui_str': '1,2-bis(hexadecyloxy)-3-trimethylaminopropane'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0426199', 'cui_str': 'Intact membranes'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0404329', 'cui_str': 'Sweeping of membrane'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",63.0,0.22185,Cesarean delivery rates were 22/32(69%) vs.19/31(61%),"[{'ForeName': 'Jesrine Gek Shan', 'Initials': 'JGS', 'LastName': 'Hong', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Jalan Profesor Diraja Ungku Aziz, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Vilasini Devi', 'Initials': 'VD', 'LastName': 'Magalingam', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Jalan Profesor Diraja Ungku Aziz, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Sethi', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Jalan Profesor Diraja Ungku Aziz, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Doris Sin Wen', 'Initials': 'DSW', 'LastName': 'Ng', 'Affiliation': 'Department of Obstetrics and Gynecology, University Malaya Medical Center, 59100, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Raymond Chung Siang', 'Initials': 'RCS', 'LastName': 'Lim', 'Affiliation': 'Department of Obstetrics and Gynecology, University Malaya Medical Center, 59100, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Peng Chiong', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Jalan Profesor Diraja Ungku Aziz, 50603, Kuala Lumpur, Malaysia.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.14166']
3387,35245895,Shoulder Kinesio Taping Does Not Change Biomechanical Deficits Associated With Scapular Dyskinesis.,"Observable scapular dyskinesis is associated with biomechanical deficits. Preventative interventions aimed at correcting these deficits may aid in preventing the development and resolution of shoulder pain. Our purpose was to investigate the effects of kinesio taping (KT) on common biomechanical deficits associated with scapular dyskinesis and shoulder pain. Participants (n = 51) with observable scapular dyskinesis, and without shoulder pain were randomized to KT, KT-placebo, or a no-treatment control group. Measurements taken before, immediately after taping, and 3 days later included pectoralis minor muscle length, lower trapezius muscle strength, scapular upward rotation angle at 0° to 120° in scapular plane humeral elevation and acromiohumeral distance. There were no changes in scapular upward rotation, lower trapezius strength, and acromiohumeral distance immediately after taping or 3 days later compared to baseline (P > .05). The pectoralis minor increased in length in the KT group on day 3 compared to directly after taping (P = .03), but no difference between groups or interaction between time and group were determined (P > .05). Scapular dyskinesis prevalence did not change over time in any group (P > .05). In people with scapular dyskinesis free from shoulder pain, KT applied to the shoulder cannot be recommended to ameliorate the biomechanical deficits associated with shoulder pain.",2022,"There were no changes in scapular upward rotation, lower trapezius strength, and acromiohumeral distance immediately after taping or 3 days later compared to baseline (P > .05).","['Participants (n = 51) with observable scapular dyskinesis, and without shoulder pain']","['KT, KT-placebo, or a no-treatment control group', 'Shoulder Kinesio Taping', 'kinesio taping (KT']","['pectoralis minor increased in length', 'Scapular dyskinesis prevalence', 'pectoralis minor muscle length, lower trapezius muscle strength, scapular upward rotation angle', 'scapular upward rotation, lower trapezius strength, and acromiohumeral distance']","[{'cui': 'C4523804', 'cui_str': 'Scapular dyskinesis'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]","[{'cui': 'C0224347', 'cui_str': 'Pectoralis minor muscle structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C4523804', 'cui_str': 'Scapular dyskinesis'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C1282911', 'cui_str': 'Upward'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",51.0,0.0686835,"There were no changes in scapular upward rotation, lower trapezius strength, and acromiohumeral distance immediately after taping or 3 days later compared to baseline (P > .05).","[{'ForeName': 'Sevgi Sevi', 'Initials': 'SS', 'LastName': 'Yeşilyaprak', 'Affiliation': 'Dokuz Eylul University.'}, {'ForeName': 'Ertuğrul', 'Initials': 'E', 'LastName': 'Yüksel', 'Affiliation': 'Dokuz Eylul University.'}, {'ForeName': 'Melike Gizem', 'Initials': 'MG', 'LastName': 'Kalaycı', 'Affiliation': 'Istanbul University-Cerrahpaşa.'}, {'ForeName': 'Nuri', 'Initials': 'N', 'LastName': 'Karabay', 'Affiliation': 'Dokuz Eylul University.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Michener', 'Affiliation': 'University of Southern California.'}]",Journal of applied biomechanics,['10.1123/jab.2021-0259']
3388,35246202,"Ceftriaxone to PRevent pneumOnia and inflammaTion aftEr Cardiac arresT (PROTECT): study protocol for a randomized, placebo-controlled trial.","BACKGROUND


Pneumonia is the most common infection after out-of-hospital cardiac arrest (OHCA) occurring in up to 65% of patients who remain comatose after return of spontaneous circulation. Preventing infection after OHCA may (1) reduce exposure to broad-spectrum antibiotics, (2) prevent hemodynamic derangements due to local and systemic inflammation, and (3) prevent infection-associated morbidity and mortality.
METHODS


The ceftriaxone to PRevent pneumOnia and inflammaTion aftEr Cardiac arrest (PROTECT) trial is a randomized, placebo-controlled, single-center, quadruple-blind (patient, treatment team, research team, outcome assessors), non-commercial, superiority trial to be conducted at Maine Medical Center in Portland, Maine, USA. Ceftriaxone 2 g intravenously every 12 h for 3 days will be compared with matching placebo. The primary efficacy outcome is incidence of early-onset pneumonia occurring < 4 days after mechanical ventilation initiation. Concurrently, T cell-mediated inflammation bacterial resistomes will be examined. Safety outcomes include incidence of type-one immediate-type hypersensitivity reactions, gallbladder injury, and Clostridioides difficile-associated diarrhea. The trial will enroll 120 subjects over approximately 3 to 4 years.
DISCUSSION


The PROTECT trial is novel in its (1) inclusion of OHCA survivors regardless of initial heart rhythm, (2) use of a low-risk antibiotic available in the USA that has not previously been tested after OHCA, (3) inclusion of anti-inflammatory effects of ceftriaxone as a novel mechanism for improved clinical outcomes, and (4) complete metagenomic assessment of bacterial resistomes pre- and post-ceftriaxone prophylaxis. The long-term goal is to develop a definitive phase III trial powered for mortality or functional outcome.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04999592 . Registered on August 10, 2021.",2022,"Safety outcomes include incidence of type-one immediate-type hypersensitivity reactions, gallbladder injury, and Clostridioides difficile-associated diarrhea.",['120 subjects over approximately 3 to 4\u2009years'],"['Ceftriaxone', 'ceftriaxone', 'placebo']","['incidence of type-one immediate-type hypersensitivity reactions, gallbladder injury, and Clostridioides difficile-associated diarrhea', 'incidence of early-onset pneumonia occurring <\u20094\u2009days after mechanical ventilation initiation']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0434028', 'cui_str': 'Injury of gallbladder'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",,0.596251,"Safety outcomes include incidence of type-one immediate-type hypersensitivity reactions, gallbladder injury, and Clostridioides difficile-associated diarrhea.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Gagnon', 'Affiliation': 'Department of Pharmacy, Maine Medical Center, Portland, ME, USA. dgagnon@mmc.org.'}, {'ForeName': 'Sergey V', 'Initials': 'SV', 'LastName': 'Ryzhov', 'Affiliation': 'Maine Medical Center Research Institute, Scarborough, ME, USA.'}, {'ForeName': 'Meghan A', 'Initials': 'MA', 'LastName': 'May', 'Affiliation': 'University of New England College of Osteopathic Medicine, Biddeford, ME, USA.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Riker', 'Affiliation': 'Tufts University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Geller', 'Affiliation': 'Tufts University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Teresa L', 'Initials': 'TL', 'LastName': 'May', 'Affiliation': 'Maine Medical Center Research Institute, Scarborough, ME, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bockian', 'Affiliation': 'Maine Medical Center Neuroscience Institute, Maine Medical Center, Portland, ME, USA.'}, {'ForeName': 'Joanne T', 'Initials': 'JT', 'LastName': 'deKay', 'Affiliation': 'Maine Medical Center Research Institute, Scarborough, ME, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Eldridge', 'Affiliation': 'Maine Medical Center Neuroscience Institute, Maine Medical Center, Portland, ME, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Van der Kloot', 'Affiliation': 'Department of Critical Care Services, Maine Medical Center, Portland, ME, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lerwick', 'Affiliation': 'Department of Critical Care Services, Maine Medical Center, Portland, ME, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lord', 'Affiliation': 'Maine Medical Center Neuroscience Institute, Maine Medical Center, Portland, ME, USA.'}, {'ForeName': 'F Lee', 'Initials': 'FL', 'LastName': 'Lucas', 'Affiliation': 'Maine Medical Center Research Institute, Scarborough, ME, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mailloux', 'Affiliation': 'Department of Critical Care Services, Maine Medical Center, Portland, ME, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'McCrum', 'Affiliation': 'Maine Medical Center Neuroscience Institute, Maine Medical Center, Portland, ME, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Searight', 'Affiliation': 'Maine Medical Center Neuroscience Institute, Maine Medical Center, Portland, ME, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Wirth', 'Affiliation': 'Department of Critical Care Services, Maine Medical Center, Portland, ME, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Zuckerman', 'Affiliation': 'Tufts University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Sawyer', 'Affiliation': 'Maine Medical Center Research Institute, Scarborough, ME, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Seder', 'Affiliation': 'Maine Medical Center Research Institute, Scarborough, ME, USA.'}]",Trials,['10.1186/s13063-022-06127-w']
3389,35246135,"A stepped-wedge randomized trial investigating the effect of the Leadership and Organizational Change for Implementation (LOCI) intervention on implementation and transformational leadership, and implementation climate.","BACKGROUND


This study evaluates the Leadership and Organizational Change for Implementation (LOCI) strategy and its effect on implementation leadership, transformational leadership, and implementation climate.
METHODS


A stepped wedge cluster randomized study design enrolling 47 first-level leaders from child- and adult-specialized mental health clinics within Norwegian health trusts across three cohorts. All therapists (n = 790) received training in screening of trauma exposure and posttraumatic stress, and a subgroup of therapists (n = 248) received training in evidence-based treatment methods for posttraumatic stress disorder (PTSD). First-level leaders and therapists completed surveys at baseline, 4, 8-, 12-, 16-, and 20-months assessing leadership and implementation climate. General linear mixed-effects models were used to investigate whether the LOCI strategy would lead to greater therapist-rated scores on implementation leadership, transformational leadership, and implementation climate.
RESULTS


After introducing the LOCI strategy, there was a significant increase in therapist-rated implementation and transformational leadership and implementation climate. The increase was sustained at all measurement time points compared to non-LOCI conditions, which demonstrated a steady decrease in scores before LOCI.
CONCLUSIONS


The LOCI strategy can develop better transformational and implementation leadership skills and contribute to a more positive implementation climate, which may enhance successful EBP implementation. Thus, LOCI can help leaders create an organizational context conducive for effective EBP implementation.
TRIAL REGISTRATION


Retrospectively registered: ClinicalTrials NCT03719651 , 25th of October 2018. The trial protocol can be accessed from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6417075/ .",2022,"After introducing the LOCI strategy, there was a significant increase in therapist-rated implementation and transformational leadership and implementation climate.",['enrolling 47 first-level leaders from child- and adult-specialized mental health clinics within Norwegian health trusts across three cohorts'],"['Leadership and Organizational Change for Implementation (LOCI) intervention', 'training in screening of trauma exposure and posttraumatic stress, and a subgroup of therapists (n\u2009=\u2009248) received training in evidence-based treatment methods']",['therapist-rated implementation and transformational leadership and implementation climate'],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0086739', 'cui_str': 'Organizational Change'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0008946', 'cui_str': 'Climate'}]",47.0,0.0774161,"After introducing the LOCI strategy, there was a significant increase in therapist-rated implementation and transformational leadership and implementation climate.","[{'ForeName': 'Ane-Marthe Solheim', 'Initials': 'AS', 'LastName': 'Skar', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies (NKVTS), Gullhaugveien 1-3, 0484, Oslo, Norway. a.m.s.skar@nkvts.no.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Braathu', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies (NKVTS), Gullhaugveien 1-3, 0484, Oslo, Norway.'}, {'ForeName': 'Nadina', 'Initials': 'N', 'LastName': 'Peters', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies (NKVTS), Gullhaugveien 1-3, 0484, Oslo, Norway.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Bækkelund', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies (NKVTS), Gullhaugveien 1-3, 0484, Oslo, Norway.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Endsjø', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies (NKVTS), Gullhaugveien 1-3, 0484, Oslo, Norway.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Babaii', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies (NKVTS), Gullhaugveien 1-3, 0484, Oslo, Norway.'}, {'ForeName': 'Randi Hovden', 'Initials': 'RH', 'LastName': 'Borge', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies (NKVTS), Gullhaugveien 1-3, 0484, Oslo, Norway.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Wentzel-Larsen', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies (NKVTS), Gullhaugveien 1-3, 0484, Oslo, Norway.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Ehrhart', 'Affiliation': 'Department of Psychology, University of Central Florida, 4111 Pictor Lane, Orlando, FL, 32816-1390, USA.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Sklar', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, 9500 Gilman Drive (0812), La Jolla, San Diego, CA, 92093-0812, USA.'}, {'ForeName': 'C Hendricks', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, 750 North Lake Shore Drive, Chicago, IL, 60611, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Aarons', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, 9500 Gilman Drive (0812), La Jolla, San Diego, CA, 92093-0812, USA.'}, {'ForeName': 'Karina M', 'Initials': 'KM', 'LastName': 'Egeland', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies (NKVTS), Gullhaugveien 1-3, 0484, Oslo, Norway.'}]",BMC health services research,['10.1186/s12913-022-07539-9']
3390,35246123,Development of methodology for assessing steroid-tapering in clinical trials for biologics in asthma.,"BACKGROUND


Long-term use of oral corticosteroids (OCS) is associated with a risk of adverse events and comorbidities. As such, a goal in assessing the efficacy of biologics in severe asthma is often to monitor reduction in OCS usage. Importantly, however, OCS dose reductions must be conducted without loss of disease control.
MAIN BODY


Herein, we describe the development of OCS-sparing study methodologies for biologic therapies in patients with asthma. In particular, we focus on four randomized, placebo-controlled, parallel-group studies of varying sizes (key single-center study [n = 20], SIRIUS [n = 135], ZONDA [n = 220], VENTURE [n = 210]) and one open-label study (PONENTE [n = 598]), which assessed the effect of asthma biologics (mepolizumab, benralizumab or dupilumab) on OCS use using predefined OCS-tapering schedules. In particular, we discuss the evolution of study design elements in these studies, including patient eligibility criteria, the use of tailored OCS dose reduction schedules, monitoring of outcomes, the use of biomarkers and use of repetitive assessments of adrenal function during OCS tapering.
CONCLUSION


Taken together, these developments have improved OCS-sparing asthma studies in recent years and the lessons learned may help with optimization of further OCS-sparing studies, and potentially clinical practice in the future.",2022,"As such, a goal in assessing the efficacy of biologics in severe asthma is often to monitor reduction in OCS usage.",['patients with asthma'],"['oral corticosteroids (OCS', 'asthma biologics (mepolizumab, benralizumab or dupilumab', 'placebo', 'ZONDA']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C2982078', 'cui_str': 'benralizumab'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.112826,"As such, a goal in assessing the efficacy of biologics in severe asthma is often to monitor reduction in OCS usage.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Korn', 'Affiliation': 'Pulmonary Department, Universitätsmedizin Mainz, Mainz, Langenbeckstr, Germany. korn@ikf-pneumologie.de.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Howarth', 'Affiliation': 'Global Medical Franchise, GSK House, Brentford, Middlesex, UK.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Smith', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Price', 'Affiliation': 'Biostatistics, GSK, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Yancey', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'Charlene M', 'Initials': 'CM', 'LastName': 'Prazma', 'Affiliation': 'Global Respiratory Franchise, GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'Elisabeth H', 'Initials': 'EH', 'LastName': 'Bel', 'Affiliation': 'Department of Respiratory Medicine, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",Respiratory research,['10.1186/s12931-022-01959-1']
3391,35246117,Establishing and evaluating physician-pharmacist collaborative clinics to manage patients with type 2 diabetes in primary hospitals in Hunan province: study protocol of a multi-site randomized controlled trial in the era of COVID-19 pandemic.,"BACKGROUND


The COVID-19 pandemic has exerted an unprecedented and universal impact on global health system, resulting in noticeable challenges in traditional chronic disease care, of which diabetes was reported to be most influenced by the reduction in healthcare resources in the pandemic. China has the world's largest diabetes population, and current diabetes management in China is unsatisfactory, particularly in rural areas. Studies in developed countries have demonstrated that physician-pharmacist collaborative clinics are efficient and cost-effective for diabetes management, but little is known if this mode could be adapted in primary hospitals in China. The aim of this proposed study is to develop and evaluate physician-pharmacist collaborative clinics to manage type 2 diabetes mellitus (T2DM) in primary hospitals in Hunan province.
METHODS


A multi-site randomized controlled trial will be conducted to evaluate the effectiveness and cost-effectiveness of the physician-pharmacist collaborative clinics compared with usual care for Chinese patients with T2DM. Six primary hospitals will participate in the study, which will recruit 600 eligible patients. Patients in the intervention group will receive services from both physicians and pharmacists in the collaborative clinics, while the control group will receive usual care from physicians. Patients will be followed up at the 3rd, 6th, 9th and 12th month. Comparison between the two groups will be conducted by assessing the clinical parameters, process indicators and costs on diabetes. A satisfaction survey will also be carried out at the end of the study.
DISCUSSION


If effective, the physician-pharmacist collaborative clinics can be adapted and used in primary hospitals of China to improve glycemic control, enhance medication adherence, decrease incidence of complications and reduce patients' dependence on physicians. Findings from the present study are meaningful for developing evidence-based diabetes care policy in rural China, especially in the COVID-19 pandemic era.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR2000031839 , Registered 12 April 2020.",2022,"Studies in developed countries have demonstrated that physician-pharmacist collaborative clinics are efficient and cost-effective for diabetes management, but little is known if this mode could be adapted in primary hospitals in China.","['primary hospitals in Hunan province', '600 eligible patients', 'patients with type 2 diabetes in primary hospitals in Hunan province', 'Chinese patients with T2DM', 'primary hospitals in China']","['physician-pharmacist collaborative clinics', 'services from both physicians and pharmacists in the collaborative clinics, while the control group will receive usual care from physicians']",['effectiveness and cost-effectiveness'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",600.0,0.0904825,"Studies in developed countries have demonstrated that physician-pharmacist collaborative clinics are efficient and cost-effective for diabetes management, but little is known if this mode could be adapted in primary hospitals in China.","[{'ForeName': 'Sheng-Lan', 'Initials': 'SL', 'LastName': 'Tan', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, 410011, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, 410011, China.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Yuan', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, 410011, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, 410011, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, 410011, China.'}, {'ForeName': 'Da-Xiong', 'Initials': 'DX', 'LastName': 'Xiang', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, 410011, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Endocrine, The Second Xiangya Hospital, Central South University, Changsha, 410011, China.'}, {'ForeName': 'Yan-Gang', 'Initials': 'YG', 'LastName': 'Zhou', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, 410011, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Pharmacy, Taoyuan People's Hospital, Changde, 415700, China.""}, {'ForeName': 'Hai-Ying', 'Initials': 'HY', 'LastName': 'Huang', 'Affiliation': ""Department of Pharmacy, The People's Hospital of Liuyang, Changsha, 410300, China.""}, {'ForeName': 'Dan-Hui', 'Initials': 'DH', 'LastName': 'Zhao', 'Affiliation': ""Department of Pharmacy, The First People's Hospital of Pingjiang, Yueyang, 410400, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, People's Hospital of Ningxiang, Changsha, 410600, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacy, Yueyang Central Hospital, Yueyang, 414020, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, The Second People's Hospital of Huaihua, Huaihua, 418000, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Pharmacy, Yiyang Central Hospital, Yiyang, 413000, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Changsha, 410011, China. xuping1109@csu.edu.cn.'}]",BMC health services research,['10.1186/s12913-022-07653-8']
3392,35246099,Is patient activation a mediator of the effect of a health promoting intervention in adults at high risk of type 2 diabetes? A longitudinal path model analysis within a randomised trial.,"BACKGROUND


Exploring mediators of preventive intervention effects has important implications for the planning of complex interventions. Our aim was to assess the extent to which knowledge, skills and confidence to manage health, here measured as ""patient activation"", was a mediator of the effect of the intervention ""Live your life without diabetes"" on weight, waist circumference and systolic blood pressure at 12 months follow-up in adults at high risk of type 2 diabetes.
METHODS


Autoregressive path models with three time points of measurement, and contemporaneous and constant b paths were used in a randomised controlled trial (RCT). The RCT took place in a Danish municipal healthcare center and included 127 individuals aged 28 to 70 years with fasting plasma glucose: 6.1-6.9 mmol/l and/or glycated haemoglobin (HbA 1c ): 42.0-47.9 mmol/mol. Participants were randomised to routine care (n = 64), or intervention (n = 63). The intervention group received an empirical and theory-based intervention delivered over four two-h group sessions during five weeks, and two further sessions after one and six months. The outcomes were weight, waist circumference and systolic blood pressure, and the mediator was patient activation, measured by the self-reported Patient Activation Measure (PAM). Data for the present study was derived from questionnaires and clinical measures from baseline, three- and 12-months follow-up.
RESULTS


Mediated effects via PAM on: weight: - 0.09 kg (95% CI - 0.38 to 0.20) out of the total effect - 1.09 kg (95% CI - 3.05 to 0.87); waist circumference: - 0.04 cm (95% CI - 0.36 to 0.28) out of the total effect - 1.86 cm (95% CI - 4.10 to 0.39); and systolic blood pressure: - 0.31 mmHg (- 1.10 to 0.49) out of the total effect - 2.73 mmHg (95% CI - 6.34 to 0.87).
CONCLUSION


We found no mediating effects of patient activation as a single variable of the intervention ""Live your life without diabetes"" on weight, waist circumference and systolic blood pressure at 12 months follow-up in adults at high risk of type 2 diabetes. Our study demonstrates an analytic approach for estimating mediating effects in complex interventions that comply with the criteria on temporal ordered data. Future studies should include possible interacting variables.",2022,"We found no mediating effects of patient activation as a single variable of the intervention ""Live your life without diabetes"" on weight, waist circumference and systolic blood pressure at 12 months follow-up in adults at high risk of type 2 diabetes.","['adults at high risk of type 2 diabetes', '127 individuals aged 28 to 70\u2009years with fasting plasma glucose: 6.1-6.9\u2009mmol/l and/or glycated haemoglobin (HbA 1c ): 42.0-47.9\u2009mmol/mol']",['health promoting intervention'],"['weight, waist circumference and systolic blood pressure', 'systolic blood pressure', 'weight, waist circumference and systolic blood pressure, and the mediator was patient activation, measured by the self-reported Patient Activation Measure (PAM']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}]",127.0,0.163485,"We found no mediating effects of patient activation as a single variable of the intervention ""Live your life without diabetes"" on weight, waist circumference and systolic blood pressure at 12 months follow-up in adults at high risk of type 2 diabetes.","[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Frydenberg', 'Affiliation': 'Department of Public Health, Aarhus University, Denmark, MFStat, Aarhus, Denmark.'}, {'ForeName': 'Helle Terkildsen', 'Initials': 'HT', 'LastName': 'Maindal', 'Affiliation': 'Department of Public Health, Aarhus University, Denmark, MFStat, Aarhus, Denmark.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Fletcher', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Juul', 'Affiliation': 'Department of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Aarhus, Denmark. lise.juul@clin.au.dk.'}]",BMC public health,['10.1186/s12889-022-12864-z']
3393,35247530,Adverse pregnancy outcomes are associated with an increased risk of postpartum prediabetes and diabetes in Chinese women with gestational diabetes.,"AIMS


To explore associations between adverse pregnancy outcomes and risk of postpartum diabetes and prediabetes among Chinese women with gestational diabetes mellitus (GDM).
METHODS


A total of 507 women with GDM who participated in a randomized controlled trial were successfully followed up at a median of 9.1 weeks (interquartile range: 7.7-11.3) weeks after delivery and underwent a 75g 2-h oral glucose tolerance test. GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Group's criteria. Postpartum diabetes and prediabetes were defined by the World Health Organization's. Generalized logit model was used to obtain odds ratios (OR) and 95% confidence interval (CI) of adverse pregnancy outcomes for postpartum diabetes, prediabetes and abnormal glucose regulation (AGR).
RESULTS


Of 507 women with GDM, 3.7% (19) women developed postpartum diabetes, 35.1% (178) women developed postpartum prediabetes. Preterm birth was associated with increased risk of postpartum prediabetes and AGR (adjusted OR: 3.24, 95%CI: 1.48-7.07 & 3.16, 1.46-6.85). Low birth weight was associated with the risk of postpartum prediabetes, diabetes and AGR (adjusted OR: 2.78, 95%CI: 1.13-6.86; 5.21, 1.13-24.02 & 2.99, 1.24-7.21).
CONCLUSIONS


Preterm birth and low birth weight were predictive of postpartum prediabetes, diabetes or AGR in Chinese women with GDM.",2022,"Preterm birth was associated with increased risk of postpartum prediabetes and AGR (adjusted OR: 3.24, 95%CI: 1.48-7.07 & 3.16, 1.46-6.85).","['Chinese women with GDM', 'Chinese women with gestational diabetes mellitus (GDM', '507 women with GDM who participated', '507 women with GDM, 3.7% (19) women developed postpartum diabetes, 35.1% (178', 'Chinese women with gestational diabetes']",['GDM'],"['risk of postpartum prediabetes and diabetes', 'postpartum prediabetes', 'risk of postpartum prediabetes and AGR', 'Low birth weight', 'adverse pregnancy outcomes for postpartum diabetes, prediabetes and abnormal glucose regulation (AGR', 'Preterm birth']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}]","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0580546', 'cui_str': 'Blood glucose abnormal'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",507.0,0.296223,"Preterm birth was associated with increased risk of postpartum prediabetes and AGR (adjusted OR: 3.24, 95%CI: 1.48-7.07 & 3.16, 1.46-6.85).","[{'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Ninghua', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Cuiping', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Jinnan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Leng', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Leishen', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Population Cancer Research Program, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': 'Chronic Disease Epidemiology Laboratory, Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China; Tianjin Center for International Collaborative Research on Environment, Nutrition and Public Health, Tianjin, China; Tianjin Key Laboratory of Environment, Nutrition and Public Health, Tianjin, China. Electronic address: leejing1990@hotmail.com.'}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China; Tianjin Center for International Collaborative Research on Environment, Nutrition and Public Health, Tianjin, China; Tianjin Key Laboratory of Environment, Nutrition and Public Health, Tianjin, China. Electronic address: yangxilin@tmu.edu.cn.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2022.109817']
3394,35247524,Title: Gestational Weight Gain in Women with Type 2 Diabetes and Perinatal Outcomes: A Secondary Analysis of the Metformin in Women with Type 2 Diabetes in Pregnancy (MiTy) Trial.,"AIMS


Our study assesses perinatal outcomes among women with type 2 diabetes, with gestational weight gain (GWG) within and outside of US Institute of Medicine (IOM) guidelines, by conducting a secondary analysis of the Metformin in Type 2 Diabetes in Pregnancy (MiTy) trial.
METHODS


460 participants were classified into three cohorts by total and weekly GWG (excessive, appropriate vs. restricted according to IOM). The primary outcome was birthweight z score, and secondary outcomes included both maternal and fetal outcomes.
RESULTS


Women with restricted (total and weekly) GWG had lower birthweight z score, lower fetal birthweight, and lower neonatal body fat mass. Women with restricted weekly GWG had fewer LGA, extreme LGA, and lower neonatal body fat mass infants, but more SGA and preterm births. Women with excessive (total and weekly) GWG had higher maternal total insulin doses in the third trimester. Women with excessive weekly GWG had more preeclampsia and higher SGA.
CONCLUSIONS


Restricted GWG among women with type 2 diabetes is associated with both benefits and harms. Both must be considered when counseling patients.",2022,"GWG had lower birthweight z score, lower fetal birthweight, and lower neonatal body fat mass.","['Women with Type 2 Diabetes and Perinatal Outcomes', 'Women with Type 2 Diabetes in Pregnancy (MiTy) Trial', '460 participants were classified into three cohorts by total and weekly GWG (excessive, appropriate vs. restricted according to IOM', 'Women with excessive (total and weekly', 'Women with restricted (total and weekly', 'women with type 2 diabetes', 'women with type 2 diabetes, with gestational weight gain (GWG) within and outside of US Institute of Medicine (IOM) guidelines']","['GWG', 'Metformin']","['preeclampsia and higher SGA', 'Title: Gestational Weight Gain', 'lower birthweight z score, lower fetal birthweight, and lower neonatal body fat mass', 'birthweight z score, and secondary outcomes included both maternal and fetal outcomes', 'maternal total insulin doses']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",460.0,0.149202,"GWG had lower birthweight z score, lower fetal birthweight, and lower neonatal body fat mass.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tomlinson', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada; University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Denice S', 'Initials': 'DS', 'LastName': 'Feig', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Sinai Health System, Toronto, Ontario, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, Ontario, Canada. Electronic address: d.feig@utoronto.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes research and clinical practice,['10.1016/j.diabres.2022.109811']
3395,35247512,Injection of leukocyte-poor platelet-rich plasma for moderate-to-large rotator cuff tears do not improve clinical outcomes but reduce retear rates and fatty infiltration: A prospective single-blinded randomized study.,"OBJECTIVES


To determine whether leukocyte-poor platelet-rich plasma (Lp-PRP) reduced retear rates, reduced fatty infiltration and improved functional outcomes in patients with degenerative moderate-to-large RCTs.
METHODS


This was a randomized controlled study at a single centre. Consecutive series of 104 patients with moderate-to-large rotator cuff tears were enrolled and randomly allocated to a control group (double-row suture-bridge arthroscopic rotator cuff repair alone, n=52) and a study group (double-row suture-bridge repair followed by three Lp-PRP injections at the tendon repair site during surgery, at days 7 and 14 after surgery, n=52). All patients were followed up for 27.2 months (range 24-36 months), with UCLA shoulder rating scale, the Constant score and a visual analog scale (VAS) evaluated respectively. The integrity and fatty infiltration of repaired tissue were assessed by MRI using the Sugaya classification and Goutallier grade classification at 24 months after surgery. Statistical analysis was performed based on T-test, chi-square test and the Kendall tau-b correlation coefficient.
RESULTS


4 patients refused follow-up, and 11 patients had incomplete data. Eventually, a total of 89 patients were available for 24 months follow-up. The mean UCLA score increased from 14.802.53 to 29.372.06 in control group and from 13.743.30 to 30.142.32 in study group (p=0.103). The mean Constant score increased from 46.565.90 to 86.834.94 in control group and from 44.377.92 to 88.804.92 in study group (p=0.063). The VAS score decreased from 3.221.24 to 0.971.12 in control group and in 3.491.52 to 1.160.99 in study group (p=0.41). All differences of UCLA score, Constant score and VAS between pre- and post-operation achieve minimal clinically important difference (MCID) proposed for arthroscopic rotator cuff repair. Of the 89 patients, 76 had MRI performed at 24 months after surgery. The retear rate was 17.6% in study group, which was lower than that in control group (38.1%, p=0.049). And the Goutallier grade was found to be significant difference between groups postoperatively (Kendall tau-b -0.24, p=0.03), but no significant difference preoperatively (Kendall tau-b -0.18, p=0.11). There were no complications in all patients.
CONCLUSION


Our procedures, involving repeated injections of Lp-PRP during surgery and at days 7 and 14, as described in this study, has positive effects on reducing retear rate and promoting Goutallier grade by patients following arthroscopic RCR, and could also provide substantial clinical outcomes that reaching MCID for surgical treatment. However, given the numbers available for analysis, it did not promote better clinical results when compared with the control group.",2022,The VAS score decreased from 3.221.24 to 0.971.12 in control group and in 3.491.52 to 1.160.99 in study group (p=0.41).,"['104 patients with moderate-to-large rotator cuff tears', 'patients with degenerative moderate-to-large RCTs']","['control group (double-row suture-bridge arthroscopic rotator cuff repair alone, n=52) and a study group (double-row suture-bridge repair followed by three Lp-PRP injections', 'leukocyte-poor platelet-rich plasma']","['VAS score', 'integrity and fatty infiltration of repaired tissue', 'UCLA shoulder rating scale, the Constant score and a visual analog scale (VAS', 'mean UCLA score', 'mean Constant score', 'UCLA score, Constant score and VAS', 'retear rate']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0333575', 'cui_str': 'Fatty infiltration'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",104.0,0.0707372,The VAS score decreased from 3.221.24 to 0.971.12 in control group and in 3.491.52 to 1.160.99 in study group (p=0.41).,"[{'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Center for Sports Medicine, the First Affiliated Hospital, Zhejiang University School of Medicine; Institute of Sports Medicine of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'You-Zhi', 'Initials': 'YZ', 'LastName': 'Cai', 'Affiliation': 'Center for Sports Medicine, the First Affiliated Hospital, Zhejiang University School of Medicine; Institute of Sports Medicine of Zhejiang University, Hangzhou, China. Electronic address: caiyouzhi@zju.edu.cn.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Center for Sports Medicine, the First Affiliated Hospital, Zhejiang University School of Medicine; Spine Lab, Department of Orthopedic Surgery, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. Electronic address: wangyuespine@zju.edu.cn.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2022.02.007']
3396,35247444,Comparison of hydration efficacy of carbohydrate-electrolytes beverages consisting of isomaltulose and sucrose in healthy young adults: a randomized crossover trial.,"Isomaltulose is a low glycemic and insulinaemic carbohydrate now used as an alternative sweetener in beverages. However, it remains unclear if hydration status may be impacted differently with the consumption of beverages containing isomaltulose as compared to sucrose, a common beverage sweetener. Thirteen young adults (7 women) consumed 1L of a carbohydrate beverage (with low electrolyte content) containing either 6.5%-sucrose, 6.5%-isomaltulose, or water within a 15-min period. For each beverage, beverage hydration index (BHI, a composite measure of fluid balance after consuming a test beverage relative to water) was calculated from urine volume produced over a 3-hour period following ingestion of the carbohydrate beverages relative to water. The change in plasma volume (ΔPV), blood glucose, and lactate concentrations were assessed every 30-min post-beverage consumption. Isomaltulose ingestion attenuated urine production as compared to water and sucrose (P≤0.005) over the 3-hour post-ingestion period. However, no differences were observed between sucrose and water (P=0.055). BHI was 1.53±0.44 for isomaltulose (P≤0.022 vs. sucrose and water) and 1.20±0.29 for sucrose (P=0.210 vs. water). A transient reduction in ΔPV was observed following the ingestion of the isomaltulose beverage (at 30-min, P=0.007 vs. sucrose). Thereafter, no differences in ΔPV between beverages were measured. Increases in blood glucose and lactate, indices of absorption and utility of glucose, were delayed in the isomaltulose as compared to sucrose beverage. In summary, we demonstrated a greater BHI with a carbohydrate-electrolyte beverage containing isomaltulose as compared to sucrose. This may in part be attributed to a delayed absorption of isomaltulose reducing diuresis. (250/250).",2022,Isomaltulose ingestion attenuated urine production as compared to water and sucrose (P≤0.005) over the 3-hour post-ingestion period.,"['healthy young adults', 'Thirteen young adults (7 women']","['consumed 1L of a carbohydrate beverage (with low electrolyte content) containing either 6.5%-sucrose, 6.5%-isomaltulose, or water within a 15-min period', 'carbohydrate-electrolytes beverages consisting of isomaltulose and sucrose']","['BHI', 'ΔPV', 'blood glucose and lactate, indices of absorption and utility of glucose', 'change in plasma volume (ΔPV), blood glucose, and lactate concentrations']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0064002', 'cui_str': 'isomaltulose'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",13.0,0.0288319,Isomaltulose ingestion attenuated urine production as compared to water and sucrose (P≤0.005) over the 3-hour post-ingestion period.,"[{'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Amano', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, Japan. Electronic address: amano@ed.niigata-u.ac.jp.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Watanabe', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, Japan.'}, {'ForeName': 'Junto', 'Initials': 'J', 'LastName': 'Otsuka', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Takada', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Fujii', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Japan.'}, {'ForeName': 'Glen P', 'Initials': 'GP', 'LastName': 'Kenny', 'Affiliation': 'Human and Environmental Physiology Research Unit, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Enoki', 'Affiliation': 'Advanced Research Institutes, Bourbon Corporation, Niigata, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Maejima', 'Affiliation': 'Advanced Research Institutes, Bourbon Corporation, Niigata, Japan.'}]",Physiology & behavior,['10.1016/j.physbeh.2022.113770']
3397,35247871,Outcomes with durvalumab after chemoradiotherapy in stage IIIA-N2 non-small-cell lung cancer: an exploratory analysis from the PACIFIC trial.,"BACKGROUND


The phase III PACIFIC trial (NCT02125461) established consolidation durvalumab as standard of care for patients with unresectable, stage III non-small-cell lung cancer (NSCLC) and no disease progression following chemoradiotherapy (CRT). In some cases, patients with stage IIIA-N2 NSCLC are considered operable, but the relative benefit of surgery is unclear. We report a post hoc, exploratory analysis of clinical outcomes in the PACIFIC trial, in patients with or without stage IIIA-N2 NSCLC.
MATERIALS AND METHODS


Patients with unresectable, stage III NSCLC and no disease progression after ≥2 cycles of platinum-based, concurrent CRT were randomized 2 : 1 to receive durvalumab (10 mg/kg intravenously; once every 2 weeks for up to 12 months) or placebo, 1-42 days after CRT. The primary endpoints were progression-free survival (PFS; assessed by blinded independent central review according to RECIST version 1.1) and overall survival (OS). Treatment effects within subgroups were estimated by hazard ratios (HRs) from unstratified Cox proportional hazards models.
RESULTS


Of 713 randomized patients, 287 (40%) had stage IIIA-N2 disease. Baseline characteristics were similar between patients with and without stage IIIA-N2 NSCLC. With a median follow-up of 14.5 months (range: 0.2-29.9 months), PFS was improved with durvalumab versus placebo in both patients with [HR = 0.46; 95% confidence interval (CI), 0.33-0.65] and without (HR = 0.62; 95% CI 0.48-0.80) stage IIIA-N2 disease. Similarly, with a median follow-up of 25.2 months (range: 0.2-43.1 months), OS was improved with durvalumab versus placebo in patients with (HR = 0.56; 95% CI 0.39-0.79) or without (HR = 0.78; 95% CI 0.57-1.06) stage IIIA-N2 disease. Durvalumab had a manageable safety profile irrespective of stage IIIA-N2 status.
CONCLUSIONS


Consistent with the intent-to-treat population, treatment benefits with durvalumab were confirmed in patients with stage IIIA-N2, unresectable NSCLC. Prospective studies are needed to determine the optimal treatment approach for patients who are deemed operable.",2022,"Durvalumab had a manageable safety profile irrespective of stage IIIA-N2 status.
","['patients with stage IIIA-N2, unresectable NSCLC', 'Patients with unresectable, stage III NSCLC and no disease progression after ≥2 cycles of platinum-based, concurrent CRT', 'stage IIIA-N2 non-small-cell lung cancer', 'patients who are deemed operable', 'patients with or without stage IIIA-N2 NSCLC', 'patients with unresectable, stage III non-small-cell lung cancer (NSCLC) and no disease progression following chemoradiotherapy (CRT', 'Of 713 randomized patients, 287 (40']","['durvalumab after chemoradiotherapy', 'durvalumab', 'placebo']","['OS', 'progression-free survival (PFS; assessed by blinded independent central review according to RECIST version 1.1) and overall survival (OS', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C4517682', 'cui_str': '287'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}]",713.0,0.703841,"Durvalumab had a manageable safety profile irrespective of stage IIIA-N2 status.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Senan', 'Affiliation': 'Department of Radiation Oncology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands. Electronic address: s.senan@amsterdamumc.nl.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Daniel', 'Affiliation': 'Tennessee Oncology, Chattanooga, USA; Sarah Cannon Research Institute, Nashville, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Villegas', 'Affiliation': 'Cancer Specialists of North Florida, Jacksonville, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Murakami', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': 'Westmead Hospital and the University of Sydney, Sydney, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Universidad Complutense, CiberOnc, CNIO and Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mann', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Dennis', 'Affiliation': 'AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, USA.'}]",ESMO open,['10.1016/j.esmoop.2022.100410']
3398,35247847,"Modification of subcutaneous white adipose tissue inflammation by omega-3 fatty acids is limited in human obesity-a double blind, randomised clinical trial.","BACKGROUND


Obesity is associated with enhanced inflammation. However, investigation in human subcutaneous white adipose tissue (scWAT) is limited and the mechanisms by which inflammation occurs have not been well elucidated. Marine long chain omega-3 polyunsaturated fatty acids (LC n-3 PUFAs) have anti-inflammatory actions and may reduce scWAT inflammation.
METHODS


Subcutaneous white adipose tissue (scWAT) biopsies were collected from individuals living with obesity (n=45) and normal weight individuals (n=39) prior to and following a 12-week intervention with either 3 g/day of a fish oil concentrate (providing 1.1 g eicosapentaenoic acid (EPA) + 0.8 g docosahexaenoic acid (DHA)) or 3 g/day of corn oil. ScWAT fatty acid, oxylipin, and transcriptome profiles were assessed by gas chromatography, ultra-pure liquid chromatography tandem mass spectrometry, RNA sequencing and qRT-PCR, respectively.
FINDINGS


Obesity was associated with greater scWAT inflammation demonstrated by lower concentrations of specialised pro-resolving mediators (SPMs) and hydroxy-DHA metabolites and an altered transcriptome with differential expression of genes involved in LC n-3 PUFA activation, oxylipin synthesis, inflammation, and immune response. Intervention with LC n-3 PUFAs increased their respective metabolites including the SPM precursor 14-hydroxy-DHA in normal weight individuals and decreased arachidonic acid derived metabolites and expression of genes involved in immune and inflammatory response with a greater effect in normal weight individuals.
INTERPRETATION


Downregulated expression of genes responsible for fatty acid activation and metabolism may contribute to an inflammatory oxylipin profile and limit the effects of LC n-3 PUFAs in obesity. There may be a need for personalised LC n-3 PUFA supplementation based on obesity status.
FUNDING


European Commission Seventh Framework Programme (Grant Number 244995) and Czech Academy of Sciences (Lumina quaeruntur LQ200111901).",2022,"FINDINGS


Obesity was associated with greater scWAT inflammation demonstrated by lower concentrations of specialised pro-resolving mediators (SPMs) and hydroxy-DHA metabolites and an altered transcriptome with differential expression of genes involved in LC n-3 PUFA activation, oxylipin synthesis, inflammation, and immune response.","['Subcutaneous white adipose tissue (scWAT', 'individuals living with obesity (n=45) and normal weight individuals (n=39) prior to']","['LC n-3 PUFAs', 'fish oil concentrate (providing 1.1 g eicosapentaenoic acid (EPA)\xa0+\xa00.8 g docosahexaenoic acid (DHA)) or 3 g/day of corn oil', 'omega-3 fatty acids', 'Marine long chain omega-3 polyunsaturated fatty acids (LC n-3 PUFAs']","['ScWAT fatty acid, oxylipin, and transcriptome profiles']","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1704223', 'cui_str': 'White Adipose Tissue'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C1956267', 'cui_str': 'Transcriptome Profiles'}]",,0.313308,"FINDINGS


Obesity was associated with greater scWAT inflammation demonstrated by lower concentrations of specialised pro-resolving mediators (SPMs) and hydroxy-DHA metabolites and an altered transcriptome with differential expression of genes involved in LC n-3 PUFA activation, oxylipin synthesis, inflammation, and immune response.","[{'ForeName': 'Helena L', 'Initials': 'HL', 'LastName': 'Fisk', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, Southampton General Hospital, University of Southampton, IDS Building, MP887, Tremona Road, Southampton SO16 6YD, United Kingdom. Electronic address: h.fisk@soton.ac.uk.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Childs', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, Southampton General Hospital, University of Southampton, IDS Building, MP887, Tremona Road, Southampton SO16 6YD, United Kingdom.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Miles', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, Southampton General Hospital, University of Southampton, IDS Building, MP887, Tremona Road, Southampton SO16 6YD, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ayres', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, Southampton General Hospital, University of Southampton, IDS Building, MP887, Tremona Road, Southampton SO16 6YD, United Kingdom.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Noakes', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, Southampton General Hospital, University of Southampton, IDS Building, MP887, Tremona Road, Southampton SO16 6YD, United Kingdom; Medical School, University of Notre Dame Australia, Fremantle, Australia.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Paras-Chavez', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, Southampton General Hospital, University of Southampton, IDS Building, MP887, Tremona Road, Southampton SO16 6YD, United Kingdom.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Kuda', 'Affiliation': 'Institute of Physiology, Czech Academy of Sciences, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kopecký', 'Affiliation': 'Institute of Physiology, Czech Academy of Sciences, Prague, Czech Republic.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Antoun', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, Southampton General Hospital, University of Southampton, IDS Building, MP887, Tremona Road, Southampton SO16 6YD, United Kingdom.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Lillycrop', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, Southampton General Hospital, University of Southampton, IDS Building, MP887, Tremona Road, Southampton SO16 6YD, United Kingdom; School of Biological Sciences, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, Southampton General Hospital, University of Southampton, IDS Building, MP887, Tremona Road, Southampton SO16 6YD, United Kingdom; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, United Kingdom.'}]",EBioMedicine,['10.1016/j.ebiom.2022.103909']
3399,35247831,Effects of workstation adjustment to reduce postural exposure and perceived discomfort among office workers - A cluster randomized controlled trial.,"This study aimed to evaluate the effects of workstation adjustment to reduce postural exposure and perceived discomfort among office workers in a cluster randomized controlled trial. Experimental (EG, n = 31) and control groups (CG, n = 30) were compared before (pre-intervention), immediately (post-intervention), and 3 months after (follow up) the intervention. EG received workstation adjustments and CG did not received the intervention. Postural exposure of head, upper back and upper arms was objectively measured by inclinometers. Overall level of perceived discomfort for the whole body was evaluated using a visual analogue scale (0-100 mm). EG showed a statistically significant reduction on the head (pre: 10.1°, SD 5.7°; post: 6.6°, SD 4.7°) and upper back flexion (pre: 15.4°, SD 10.7°; post: 10.4°, SD 8.4°) from pre to post-intervention. EG also showed a statistically significant reduction from pre (50.7°, SD 9.5°) to post-intervention (42.1°, SD 7.6°) and from pre to follow up (41.6°, SD 6.5°) on upper arm elevation. CG did not show any difference between evaluations. Perceived discomfort increased 7.2 (SD 2.0) mm in CG and decreased 22.1 (SD 2.2) mm in EG between pre and post intervention. The variation between pre intervention and follow up was 4.5 (SD 1.2) mm increase for the CG and 24.1 (SD 1.5) mm of reduction for the EG (P < 0.01). There was no significant difference for the post intervention and follow up for both groups (P > 0.05). The results show evidence of the workstation adjustment to reduce postural exposure and perceived discomfort among office workers.",2022,"EG also showed a statistically significant reduction from pre (50.7°, SD 9.5°) to post-intervention (42.1°, SD 7.6°) and from pre to follow up (41.6°, SD 6.5°) on upper arm elevation.",[],['workstation adjustment'],"['Overall level of perceived discomfort', 'postural exposure and perceived discomfort', 'upper back flexion', 'visual analogue scale', 'Perceived discomfort']",[],"[{'cui': 'C1736830', 'cui_str': 'Workstation'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0230101', 'cui_str': 'Upper back structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",30.0,0.0326351,"EG also showed a statistically significant reduction from pre (50.7°, SD 9.5°) to post-intervention (42.1°, SD 7.6°) and from pre to follow up (41.6°, SD 6.5°) on upper arm elevation.","[{'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Cabegi de Barros', 'Affiliation': 'Laboratory of Preventive Physical Therapy and Ergonomics (LAFIPE), Physical Therapy Post Graduate Program, Federal University of São Carlos, São Carlos, São Paulo, Brazil. Electronic address: fernanda.c.barros@gmail.com.'}, {'ForeName': 'Cristiane Shinohara', 'Initials': 'CS', 'LastName': 'Moriguchi', 'Affiliation': 'Laboratory of Preventive Physical Therapy and Ergonomics (LAFIPE), Physical Therapy Post Graduate Program, Federal University of São Carlos, São Carlos, São Paulo, Brazil. Electronic address: cristiane.moriguchi@ufscar.br.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'de Oliveira Sato', 'Affiliation': 'Laboratory of Preventive Physical Therapy and Ergonomics (LAFIPE), Physical Therapy Post Graduate Program, Federal University of São Carlos, São Carlos, São Paulo, Brazil. Electronic address: tatisato@ufscar.br.'}]",Applied ergonomics,['10.1016/j.apergo.2022.103738']
3400,35247824,Dual-task training effect on gait parameters in children with spastic diplegic cerebral palsy: Preliminary results of a self-controlled study.,"BACKGROUND


Children with cerebral palsy (CP) may have difficulties under dual-task conditions. Spatiotemporal gait parameters have deteriorated with concurrent tasks in children with CP. However, how dual-task training affects gait parameters in children with spastic diplegic CP has not been clarified.
RESEARCH QUESTION


How does dual-task training program effect gait, functional skills, and health-related quality of life in children with spastic diplegic CP?
METHODS


Eleven children with spastic diplegic CP (median age 11 y, range 7-16 y; 4 female; 7 male) Gross Motor Function Classification System level 1-2 and obtained 27 and higher scores from Modified Mini Mental Test included in the study. The study was planned as a self-controlled clinical research design. Children were recruited to conventional physiotherapy program for 8 weeks and dual-task training program added to conventional physiotherapy program for following 8 weeks. Children were evaluated at baseline, after conventional physiotherapy program, and after dual-task training program. Children's gait was evaluated with Zebris™ FDM-2 device and Edinburgh Visual Gait Score, functional mobility skills with 1 min Walk Test (1MWT), and health-related quality of life with the Pediatric Quality of Life Inventory (PedsQL) - CP module.
RESULTS


The difference in step length, step time, stride time, cadence and gait speed of spatiotemporal parameters of gait during dual-task performance were found statistically significant in children with spastic diplegic CP, after dual-task training program (p < 0,05). After dual-task training, statistically significant gains were found in 1MWT, movement and balance subtitle of PedsQL-CP module Parent Form (p < 0,05).
SIGNIFICANCE


Dual-task training program added to a conventional physiotherapy program provides more gains in terms of functionality of children with spastic diplegic CP will contribute to the improvement of the motor functional level.",2022,"After dual-task training, statistically significant gains were found in 1MWT, movement and balance subtitle of PedsQL-CP module Parent Form (p < 0,05).
","['Children with cerebral palsy (CP', 'children with spastic diplegic CP', 'children with CP', 'Eleven children with spastic diplegic CP (median age 11', 'children with spastic diplegic cerebral palsy', 'y, range 7-16\xa0y; 4 female; 7 male) Gross Motor Function Classification System level 1-2 and obtained 27 and higher scores from Modified Mini Mental Test included in the study']","['conventional physiotherapy program for 8 weeks and dual-task training program added to conventional physiotherapy program', 'Dual-task training', 'conventional physiotherapy program']","['Zebris™ FDM-2 device and Edinburgh Visual Gait Score, functional mobility skills with 1\xa0min Walk Test (1MWT), and health-related quality of life with the Pediatric Quality of Life Inventory (PedsQL', 'gait parameters', 'functional skills, and health-related quality of life', 'step length, step time, stride time, cadence and gait speed of spatiotemporal parameters of gait during dual-task performance', '1MWT, movement and balance subtitle of PedsQL-CP module']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0025365', 'cui_str': 'Mental Tests'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C3542953', 'cui_str': 'Module'}]",11.0,0.00812613,"After dual-task training, statistically significant gains were found in 1MWT, movement and balance subtitle of PedsQL-CP module Parent Form (p < 0,05).
","[{'ForeName': 'Eda Ozge', 'Initials': 'EO', 'LastName': 'Okur', 'Affiliation': 'Kutahya Health Sciences University, Faculty of Health Sciences, Department of Occupational Therapy, Kutahya, Turkey,. Electronic address: eda-ozge@hotmail.com.'}, {'ForeName': 'Meltem Isintas', 'Initials': 'MI', 'LastName': 'Arik', 'Affiliation': 'Kutahya Health Sciences University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Kutahya, Turkey.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Okur', 'Affiliation': 'Kutahya Health Sciences University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Kutahya, Turkey.'}, {'ForeName': 'Hasan Huseyin', 'Initials': 'HH', 'LastName': 'Gokpinar', 'Affiliation': 'Kutahya Health Sciences University, Faculty of Medicine, Kutahya, Turkey.'}, {'ForeName': 'Mintaze Kerem', 'Initials': 'MK', 'LastName': 'Gunel', 'Affiliation': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Samanpazari, Ankara, Turkey.'}]",Gait & posture,['10.1016/j.gaitpost.2022.02.020']
3401,35247794,The Disease Recovery Evaluation and Modification (DREaM) study: Effectiveness of paliperidone palmitate versus oral antipsychotics in patients with recent-onset schizophrenia or schizophreniform disorder.,"We report primary results of the Disease Recovery Evaluation and Modification (DREaM) study, a randomized, open-label, delayed-start trial designed to compare the effectiveness of paliperidone palmitate (PP) versus oral antipsychotics (OAP) in delaying time to first treatment failure (TtFTF) in participants with recent-onset schizophrenia or schizophreniform disorder. DREaM included: Part I, 2-month oral run-in; Part II, 9-month disease progression phase (PP or OAP); Part III, 9 months of additional treatment (PP/PP; OAP rerandomized: OAP/OAP or OAP/PP). PP/PP and OAP/OAP comprised the 18-month extended disease progression (EDP) analysis. A total of 235 participants were randomized to PP (n = 78) or OAP (n = 157) in Part II. No statistically significant differences in TF between treatment groups were identified during Part II (PP 29.5%, OAP 24.8%; P = 0.377), Part III (PP/PP 14.3%, OAP/PP 15.8%, OAP/OAP 28.6%; P = 0.067) or the EDP analysis (PP/PP 28.6%, OAP/OAP 44.4%; NNT = 6; P = 0.080). Using a modified definition of TF excluding treatment supplementation with another antipsychotic, a common approach to managing dose adjustments, significant differences were observed between treatment groups in Part III (PP/PP 4.1%, OAP/PP 14.0%, OAP/OAP 27.0%; P = 0.002) and EDP (PP/PP 14.3%, OAP/OAP 42.9%; P = 0.001). Safety results were consistent with the known safety profile of PP. Although significant treatment differences were not observed during the first 9 months of DREaM, numerical differences favoring PP emerged in the last 9 months and significant differences were observed when TF criteria were limited to their most impactful components. These results highlight the potential benefit of initiating PP early in the course of schizophrenia and provide valuable insights for future clinical trials in recent-onset schizophrenia or schizophreniform disorder. Clinicaltrials.gov identifier: NCT02431702.",2022,"No statistically significant differences in TF between treatment groups were identified during Part II (PP 29.5%, OAP 24.8%; P = 0.377), Part III (PP/PP 14.3%, OAP/PP 15.8%, OAP/OAP 28.6%; P = 0.067) or the EDP analysis (PP/PP 28.6%, OAP/OAP 44.4%; NNT = 6; P = 0.080).","['participants with recent-onset schizophrenia or schizophreniform disorder', '235 participants', 'patients with recent-onset schizophrenia or schizophreniform disorder']","['paliperidone palmitate (PP) versus oral antipsychotics (OAP', 'OAP', 'oral antipsychotics', 'paliperidone palmitate']","['TF', 'EDP']","[{'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036358', 'cui_str': 'Schizophreniform disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2719626', 'cui_str': 'Paliperidone palmitate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",235.0,0.129033,"No statistically significant differences in TF between treatment groups were identified during Part II (PP 29.5%, OAP 24.8%; P = 0.377), Part III (PP/PP 14.3%, OAP/PP 15.8%, OAP/OAP 28.6%; P = 0.067) or the EDP analysis (PP/PP 28.6%, OAP/OAP 44.4%; NNT = 6; P = 0.080).","[{'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Alphs', 'Affiliation': 'Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA.'}, {'ForeName': 'Brianne', 'Initials': 'B', 'LastName': 'Brown', 'Affiliation': 'Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA. Electronic address: bbrown59@its.jnj.com.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Turkoz', 'Affiliation': 'Janssen Research and Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA. Electronic address: ITurkoz@its.jnj.com.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Baker', 'Affiliation': 'Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA. Electronic address: pbaker16@its.jnj.com.'}, {'ForeName': 'Dong-Jing', 'Initials': 'DJ', 'LastName': 'Fu', 'Affiliation': 'Janssen Research and Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA. Electronic address: dfu@its.jnj.com.'}, {'ForeName': 'Keith H', 'Initials': 'KH', 'LastName': 'Nuechterlein', 'Affiliation': 'Departments of Psychiatry and Psychology, University of California at Los Angeles, 150 Medical Plaza Driveway, Los Angeles, CA 90095, USA. Electronic address: keithn@ucla.edu.'}]",Schizophrenia research,['10.1016/j.schres.2022.02.019']
3402,35247908,Putative Biomarkers of Clinical Benefit With Pembrolizumab in Advanced Urothelial Cancer: Results From the KEYNOTE-045 and KEYNOTE-052 Landmark Trials.,"PURPOSE


In an exploratory analysis, we investigated the association between PD-L1, TMB, T-cell-inflamed gene expression profile (TcellinfGEP), and stromal signature with outcomes of pembrolizumab in urothelial carcinoma (UC).
EXPERIMENTAL DESIGN


Patients with advanced UC received first-line pembrolizumab 200mg Q3W in the single-arm phase 2 KEYNOTE-052 trial (NCT02335424) and salvage pembrolizumab 200mg Q3W or chemotherapy (paclitaxel/docetaxel/vinflunine) in the randomized phase 3 KEYNOTE-045 trial (NCT02256436). The association of each biomarker (continuous variable) with ORR, PFS, and OS was evaluated using logistic regression (ORR) and Cox PH (PFS, OS), adjusted for ECOG PS; nominal P values were calculated without multiplicity adjustment (one-sided, pembrolizumab; two-sided, chemotherapy). Significance was prespecified at α=0.05.
RESULTS


In KEYNOTE-052, PD-L1, TMB, and TcellinfGEP were significantly associated with improved outcomes; stromal signature was significantly associated with worse outcomes. In KEYNOTE-045, although findings for TMB and TcellinfGEP with pembrolizumab were consistent with those of KEYNOTE-052, PD-L1 was not significantly associated with improved outcomes nor was stromal signature associated with worse outcomes with pembrolizumab; chemotherapy was not associated with outcomes in a consistent manner for any of the biomarkers. HR estimates at prespecified cutoffs showed an advantage for pembrolizumab versus chemotherapy regardless of PD-L1 or TMB, with a trend toward lower HRs in the CPS{greater than or equal to}10 and the TMB{greater than or equal to}175 mutation/exome subgroup. For TcellinfGEP, PFS and OS HRs were lower in the TcellinfGEP-nonlow subgroup regardless of treatment.
CONCLUSION


Multiple biomarkers characterizing the tumor microenvironment may help predict response to pembrolizumab monotherapy in UC and potential clinical utility of these biomarkers may be context-dependent.",2022,"For TcellinfGEP, PFS and OS HRs were lower in the TcellinfGEP-nonlow subgroup regardless of treatment.
","['urothelial carcinoma (UC', 'Advanced Urothelial Cancer', 'Patients with advanced UC received']","['TcellinfGEP', 'salvage pembrolizumab 200mg Q3W or chemotherapy (paclitaxel/docetaxel/vinflunine', 'Pembrolizumab', 'pembrolizumab', 'first-line pembrolizumab 200mg Q3W']","['For TcellinfGEP, PFS and OS HRs', 'logistic regression (ORR) and Cox PH (PFS, OS), adjusted for ECOG PS; nominal P values']","[{'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0672663', 'cui_str': 'vinflunine'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0206031', 'cui_str': 'Logistic Regression'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.141947,"For TcellinfGEP, PFS and OS HRs were lower in the TcellinfGEP-nonlow subgroup regardless of treatment.
","[{'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'de Wit', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Fradet', 'Affiliation': 'CHU de Québec-Université Laval, Quebec, Québec, Canada.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Climent', 'Affiliation': 'Fundación Instituto Valenciano de Oncologia, Valencia.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale Cancer Center, New Haven, Connecticut, United States.'}, {'ForeName': 'Jae-Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (South), Republic of.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fong', 'Affiliation': 'University of California, San Francisco, San Francisco, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Necchi', 'Affiliation': 'IRCCS San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Weill Cornell Medicine, New York, NY, United States.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': ""O'Donnell"", 'Affiliation': 'University of Chicago, Chicago, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, Royal Free NHS Trust, London, United Kingdom.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'Dean F', 'Initials': 'DF', 'LastName': 'Bajorin', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Arjun V', 'Initials': 'AV', 'LastName': 'Balar', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Medical Center, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': 'Hospital Universitario 12 De Octubre, Madrid, Spain.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Culine', 'Affiliation': 'Hopital Saint-Louis, Paris, France.'}, {'ForeName': 'Winald', 'Initials': 'W', 'LastName': 'Gerritsen', 'Affiliation': 'Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': '6129813500, Macquarie University, New South Wales, Australia.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Vuky', 'Affiliation': 'Oregon Health & Science University, Portland, OR, United States.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'US Oncology/Comprehensive Cancer Centers of Nevada, Las Vegas, NV, United States.'}, {'ForeName': 'Razvan', 'Initials': 'R', 'LastName': 'Cristescu', 'Affiliation': 'Merck Research Laboratories, Boston, MA, United States.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Lunceford', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Assieh', 'Initials': 'A', 'LastName': 'Saadatpour', 'Affiliation': 'Merck Research Labs, Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Loboda', 'Affiliation': 'Merck & Co., Inc., Boston, MA, United States.'}, {'ForeName': 'Junshui', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Rajasagi', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'James Luke', 'Initials': 'JL', 'LastName': 'Godwin', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, United States.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Homet Moreno', 'Affiliation': 'Institute of Biomedical Research. Hospital Universitario, Madrid, Madrid, Spain.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Grivas', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-3089']
3403,35247906,"Famitinib with camrelizumab and nab-paclitaxel for advanced immunomodulatory triple-negative breast cancer (FUTURE-C-PLUS): an open-label, single-arm, phase 2 trial.","PURPOSE


Camrelizumab, a monoclonal antibody against PD-1, plus nab-paclitaxel exhibited promising antitumor activity in refractory metastatic immunomodulatory triple-negative breast cancer (TNBC). Famitinib is a tyrosine kinase inhibitor targeting VEGFR2, PDGFR and c-kit. We aimed to assess the efficacy and safety of a novel combination of famitinib, camrelizumab and nab-paclitaxel in advanced immunomodulatory TNBC.
PATIENTS AND METHODS


This open-label, single-arm, phase II study enrolled patients with previously untreated, advanced, immunomodulatory TNBC (CD8 immunohistochemical staining {greater than or equal to} 10%). Eligible patients received 20 mg of oral famitinib on days 1-28, 200 mg of intravenous camrelizumab on days 1 and 15, and intravenous nab-paclitaxel 100 mg/m2 on days 1, 8 and 15 in 4-week cycles. The primary endpoint was objective response rate (ORR), as assessed by investigators per RECIST v1.1. Key secondary endpoints were progression-free survival (PFS), overall survival (OS), duration of response (DOR), safety and exploratory biomarkers.
RESULTS


Forty-eight patients were enrolled and treated. Median follow-up was 17.0 months (range, 8.7-24.3). Confirmed ORR was 81.3% (95% CI, 70.2-92.3), with 5 complete and 34 partial responses. Median PFS was 13.6 months (95% CI, 8.4-18.8), and median DOR was 14.9 months (95% CI, NE-NE). Median OS was not reached. No treatment-related deaths were reported. Among 30 patients with immunohistochemistry, 13 (43.3%) were PD-L1-positive, and PD-L1 was associated with favorable response. PKD1 and KAT6A somatic mutations were associated with therapy response.
CONCLUSIONS


The triplet regimen was efficacious and well tolerated in previously untreated, advanced, immunomodulatoryTNBC. The randomized controlled FUTURE-SUPER trial is underway to validate our findings.",2022,No treatment-related deaths were reported.,"['refractory metastatic immunomodulatory triple-negative breast cancer (TNBC', 'enrolled patients with previously untreated, advanced, immunomodulatory TNBC (CD8 immunohistochemical staining {greater than or equal to} 10', 'Forty-eight patients were enrolled and treated']","['famitinib, camrelizumab and nab-paclitaxel', 'intravenous camrelizumab', 'intravenous nab-paclitaxel', 'Famitinib with camrelizumab and nab-paclitaxel', 'oral famitinib']","['progression-free survival (PFS), overall survival (OS), duration of response (DOR), safety and exploratory biomarkers', 'efficacious and well tolerated', 'objective response rate (ORR', 'ORR', 'efficacy and safety', 'median DOR', 'Median PFS', 'Median OS']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C3273460', 'cui_str': 'famitinib'}, {'cui': 'C4682408', 'cui_str': 'camrelizumab'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",30.0,0.124253,No treatment-related deaths were reported.,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Fudan University Shanghai Cancer Center, shanghai, China.'}, {'ForeName': 'Yi-Zhou', 'Initials': 'YZ', 'LastName': 'Jiang', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China.'}, {'ForeName': 'Song-Yang', 'Initials': 'SY', 'LastName': 'Wu', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China.'}, {'ForeName': 'Gen-Hong', 'Initials': 'GH', 'LastName': 'Di', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Guang-Yu', 'Initials': 'GY', 'LastName': 'Liu', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Ke-Da', 'Initials': 'KD', 'LastName': 'Yu', 'Affiliation': 'Fudan University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Cancer Center and Cancer Institute, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': 'Breast Cancer Institution, Cancer Hospital,Fudan University, Shanghai, China.'}, {'ForeName': 'Yi-Feng', 'Initials': 'YF', 'LastName': 'Hou', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Fudan University Shanghai Cancer Center, China.'}, {'ForeName': 'Can-Ming', 'Initials': 'CM', 'LastName': 'Chen', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Huang', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China.'}, {'ForeName': 'A-Yong', 'Initials': 'AY', 'LastName': 'Cao', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Fudan Univeristy shanghai caner center, shanghai, China.'}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Ma', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xiang-Jie', 'Initials': 'XJ', 'LastName': 'Sun', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Wen-Jun', 'Initials': 'WJ', 'LastName': 'Chai', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xiaomao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Fudan University Shanghai Cancer Center, shanghai, China.'}, {'ForeName': 'Xizi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Fudan University Shanghai Cancer Center, shanghai, China.'}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Fudan University Shanghai Cancer Center, shanghai, China.'}, {'ForeName': 'Xiao-Yu', 'Initials': 'XY', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Hengrui Medicine Co. Ltd., China.'}, {'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Zou', 'Affiliation': 'Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.'}, {'ForeName': 'Wen-Tao', 'Initials': 'WT', 'LastName': 'Yang', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhong-Hua', 'Initials': 'ZH', 'LastName': 'Wang', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Shao', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-4313']
3404,35245879,A randomised double-blind controlled study of Deep Brain Stimulation for dystonia in STN or GPi - A long term follow-up after up to 15 years.,"AIM


This is a long-term open follow-up of a prospective double-blind crossover study, where electrodes were bilaterally implanted in both the Subthalamic nucleus (STN) and internal pallidum (GPi) in patients with isolated dystonia.
METHODS


Patients with isolated dystonia were included to undergo surgery with Deep Brain stimulation (DBS) and after randomization, in a double-blind cross-over study, receiving bilateral stimulation of either STN or GPi for 6 months in each target. Preoperative and postoperative assessments with the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and the 36-item Short Form Health Survey (SF-36) were performed. In this long-term follow-up (LFU), these ratings were repeated, and patients were evaluated with cognitive tests.
RESULTS


21 patients were included in the protocol, 9 patients with generalized dystonia, 12 with a diagnosis of cervical dystonia. The mean duration of disease was 19.3 years, age at time of surgery 50.1 years. Fourteen patients participated in the LFU. At a mean follow-up of 10.2 years (range 4.8-15.4), BFMDRS movement score was improved with a mean of 36% (p < 0.05) compared with baseline. At LFU both a statistically significant improvement of stimulation in STN on BFMDRS movement score (p = 0.029) and Gpi (p = 0.008) was demonstrated, no significant difference was found between the two targets (p = 0.076). SF-36 improved for both targets.
CONCLUSION


In this study we performed a long-term follow-up in 14 patients with cervical or generalized dystonia, who received stimulation in GPi, STN or both. The mean follow-up time was more than 10 years. Our data support a long-term effect of both STN-DBS and GPi-DBS in dystonia with equal effect and safety for up to 15 years. STN has been proven a viable safe and effective target and may be used as an alternative to GPi in both adult-onset cervical dystonia and generalized dystonia.",2022,"At LFU both a statistically significant improvement of stimulation in STN on BFMDRS movement score (p = 0.029) and Gpi (p = 0.008) was demonstrated, no significant difference was found between the two targets (p = 0.076).","['Patients with isolated dystonia were included to undergo surgery with Deep Brain stimulation (DBS) and after randomization, in a double-blind cross-over study, receiving bilateral stimulation of either', 'patients with isolated dystonia', '21 patients were included in the protocol, 9 patients with generalized dystonia, 12 with a diagnosis of cervical dystonia', 'Fourteen patients participated in the LFU', '14 patients with cervical or generalized dystonia, who received stimulation in GPi, STN or both']","['STN or GPi', 'Deep Brain Stimulation', 'Subthalamic nucleus (STN) and internal pallidum (GPi', 'STN', 'STN-DBS and GPi-DBS']","['stimulation in STN on BFMDRS movement score', 'Preoperative and postoperative assessments with the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and the 36-item Short Form Health Survey (SF-36', 'mean duration of disease', 'SF-36', 'BFMDRS movement score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013421', 'cui_str': 'Dystonia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0017759', 'cui_str': 'Glucose-6-phosphate isomerase'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}]","[{'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0017759', 'cui_str': 'Glucose-6-phosphate isomerase'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0017651', 'cui_str': 'Globus pallidus structure'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C3496228', 'cui_str': 'Leukodystrophy, Dysmyelinating, And Spastic Paraparesis With Or Without Dystonia'}, {'cui': 'C0013421', 'cui_str': 'Dystonia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",14.0,0.112174,"At LFU both a statistically significant improvement of stimulation in STN on BFMDRS movement score (p = 0.029) and Gpi (p = 0.008) was demonstrated, no significant difference was found between the two targets (p = 0.076).","[{'ForeName': 'Aske Nicolai', 'Initials': 'AN', 'LastName': 'Høck', 'Affiliation': 'Department of Neurology, Copenhagen University, Hospital Bispebjerg, Denmark; University of Copenhagen, Denmark.'}, {'ForeName': 'Steen Rusborg', 'Initials': 'SR', 'LastName': 'Jensen', 'Affiliation': 'Department of Neurology, Copenhagen University, Hospital Bispebjerg, Denmark.'}, {'ForeName': 'Katrine Wordenskjold', 'Initials': 'KW', 'LastName': 'Sværke', 'Affiliation': 'Department of Neurology, Copenhagen University, Hospital Bispebjerg, Denmark.'}, {'ForeName': 'Jannick', 'Initials': 'J', 'LastName': 'Brennum', 'Affiliation': 'Department of Neurosurgery, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jespersen', 'Affiliation': 'Department of Neurosurgery, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Bergdal', 'Affiliation': 'Department of Neurosurgery, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Karlsborg', 'Affiliation': 'Department of Neurology, Copenhagen University, Hospital Bispebjerg, Denmark.'}, {'ForeName': 'Lena Elisabeth', 'Initials': 'LE', 'LastName': 'Hjermind', 'Affiliation': 'Clinical Trial Unit, Danish Dementia Research Centre, Department of Neurology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Annemette', 'Initials': 'A', 'LastName': 'Løkkegaard', 'Affiliation': 'Department of Neurology, Copenhagen University Hospital, Bispebjerg, Denmark; University of Copenhagen, Denmark. Electronic address: Annemette.loekkegaard@regionh.dk.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2022.02.001']
3405,35245844,Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial.,"INTRODUCTION


Immune-mediated adverse events (imAEs), including all-cause immune-mediated pneumonitis, were reported in approximately 25% of patients in the placebo-controlled, phase III PACIFIC trial of durvalumab monotherapy (for up to 12 months) in patients with unresectable, stage III NSCLC and no disease progression after concurrent chemoradiotherapy; only 3.4% of patients experienced grade 3/4 imAEs. With broad application of the PACIFIC regimen (consolidation durvalumab after chemoradiotherapy), now standard-of-care in this setting, there is a need to better characterize the occurrence of imAEs with this regimen.
METHODS


We performed descriptive, post-hoc, exploratory analyses to characterize the occurrence of imAEs (pneumonitis and non-pneumonitis) in PACIFIC in terms of: incidence, severity, and timing; clinical management and outcomes; and associations between the occurrence of imAEs and (1) all-cause AEs and (2) baseline patient, disease, and treatment characteristics.
RESULTS


Any-grade immune-mediated pneumonitis (9.4%) and non-pneumonitis imAEs (10.7%) occurred infrequently and were more common with durvalumab versus placebo. Grade 3/4 immune-mediated pneumonitis (1.9%) and non-pneumonitis imAEs (1.7%) were uncommon with durvalumab, as were fatal imAEs (0.8%; all pneumonitis). The most common non-pneumonitis imAEs with durvalumab were thyroid disorders, dermatitis/rash, and diarrhea/colitis. Dermatitis/rash had the shortest time to onset (from durvalumab initiation), followed by pneumonitis; dermatitis/rash had the longest time to resolution, followed by thyroid disorders. Most patients with immune-mediated pneumonitis (78.4%) and non-pneumonitis imAEs (56.3%) had these events occur ≤ 3 months after initiating durvalumab. ImAEs were well managed with administration of systemic corticosteroids, administration of endocrine replacement therapy, and interruption/discontinuation of durvalumab. Time elapsed from completion of prior radiotherapy to trial randomization (<14 vs. ≥ 14 days) did not impact either incidence or severity of imAEs. Durvalumab had a manageable safety profile broadly irrespective of whether patients experienced imAEs.
CONCLUSION


The risk of imAEs should not deter use of the PACIFIC regimen in eligible patients, as these events are generally well managed through appropriate clinical intervention.",2022,Most patients with immune-mediated pneumonitis (78.4%) and non-pneumonitis imAEs (56.3%) had these events occur ≤ 3 months after initiating durvalumab.,['patients with unresectable stage III NSCLC'],"['placebo', 'durvalumab', 'durvalumab monotherapy', 'endocrine replacement therapy, and interruption/discontinuation of durvalumab', 'PACIFIC regimen (consolidation durvalumab after chemoradiotherapy']","['thyroid disorders, dermatitis/rash, and diarrhea/colitis', 'grade immune-mediated pneumonitis', 'Grade 3/4 immune-mediated pneumonitis', 'Dermatitis/rash']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0040128', 'cui_str': 'Disorder of thyroid gland'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4761220', 'cui_str': 'Immune-mediated pneumonitis'}, {'cui': 'C0442757', 'cui_str': '3/4'}]",,0.126197,Most patients with immune-mediated pneumonitis (78.4%) and non-pneumonitis imAEs (56.3%) had these events occur ≤ 3 months after initiating durvalumab.,"[{'ForeName': 'Jarushka', 'Initials': 'J', 'LastName': 'Naidoo', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD, USA; Bloomberg Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University, Baltimore, MD, USA; Beaumont Hospital Dublin, RCSI University of Health Sciences, Dublin, Ireland. Electronic address: jnaidoo1@jhmi.edu.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Vansteenkiste', 'Affiliation': 'University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Murakami', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': 'Westmead Hospital and the University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Quantin', 'Affiliation': ""ICM Val d'Aurelle and IRCM U1194, Montpellier University, Montpellier, France.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Broadhurst', 'Affiliation': 'Plus Project Ltd, Alderley Park, Macclesfield, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Newton', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Piruntha', 'Initials': 'P', 'LastName': 'Thiyagarajah', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2022.02.003']
3406,35245813,Using biofeedback to optimize scapular muscle activation ratios during a seated resisted scaption exercise.,"Impairments in muscle activation have been linked to increased risk of developing shoulder pathologies such as subacromial impingement syndrome (SIS) and associated rotator cuff injuries. Individuals with SIS have demonstrated increased upper trapezius (UT) muscle activation and reduced serratus anterior (SA) and lower trapezius (LT) muscle activation, which can be collectively represented as ratios (UT/SA and UT/LT). Targeted exercise is an important component of shoulder rehabilitation programs to re-establish optimal muscle activation and ratios. Electromyography (EMG) biofeedback during exercise has been shown to reduce UT activation and favorably alter scapular muscle activation ratios, however, a literature gap exists regarding the efficacy of other types of biofeedback. Therefore, we compared the effects of three types of biofeedback (visual EMG, auditory, verbal cues) on UT/SA and UT/LT ratios during a seated resisted scaption exercise in fifteen subjects without shoulder pain. Baseline muscle activation was recorded and compared to real-time muscle activation during each randomized biofeedback trial. All biofeedback types showed improvements in the UT/SA and UT/LT ratios, with visual EMG demonstrating a significant change in UT/LT ratio (p < 0.05). These results suggest that biofeedback could be utilized as a component of rehabilitation programs to prevent or treat shoulder pain.",2022,"Individuals with SIS have demonstrated increased upper trapezius (UT) muscle activation and reduced serratus anterior (SA) and lower trapezius (LT) muscle activation, which can be collectively represented as ratios (UT/SA and UT/LT).","['Individuals with SIS', 'fifteen subjects without shoulder pain']","['biofeedback (visual EMG, auditory, verbal cues', 'Electromyography (EMG) biofeedback']","['Baseline muscle activation', 'UT/LT ratio', 'upper trapezius (UT) muscle activation and reduced serratus anterior (SA) and lower trapezius (LT) muscle activation', 'UT/SA and UT/LT ratios']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}]",15.0,0.0940055,"Individuals with SIS have demonstrated increased upper trapezius (UT) muscle activation and reduced serratus anterior (SA) and lower trapezius (LT) muscle activation, which can be collectively represented as ratios (UT/SA and UT/LT).","[{'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Riek', 'Affiliation': 'Department of Physical Therapy, Nazareth College, Rochester, NY, United States. Electronic address: Lriek9@naz.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Pfohl', 'Affiliation': 'Department of Physical Therapy, Nazareth College, Rochester, NY, United States.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Zajac', 'Affiliation': 'Department of Physical Therapy and Athletic Training, Sargent College of Health and Rehabilitation Sciences, Boston University, Boston, MA, United States.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2022.102647']
3407,35246206,PROPHYlactic Implantation of BIOlogic Mesh in peritonitis (PROPHYBIOM): a prospective multicentric randomized controlled trial.,"BACKGROUND


Patients undergoing emergency surgery for peritonitis are at increased risk of abdominal wall-related complications. In patients with peritonitis, the risk of incisional hernia (IH) is extremely elevated. The evaluation of quality of life of patients with incisional hernia showed lower mean scores on physical components of health-related quality of life and body image. Furthermore, the arise of a post-operative abdominal wall complication (i.e., wound dehiscence, evisceration and IH) greatly increases morbidity and mortality rates and prolongs the hospitalization.
METHODS


The present study aims to evaluate the efficacy of the use of a swine dermal collagen prosthesis implanted preperitoneally as a prophylactic procedure in urgency/emergency setting against abdominal wall complications in patients operated with contaminated/infected field in peritonitis. The sample size was defined in 90 patients divided in two arms (prosthesis positioning versus normal wall abdominal closure). The follow-up will be performed at 3, 6, and 12 months after surgery. The percentage of incisional hernias, wound infections, and adverse events will be investigated by physical examination and ultrasound.
DISCUSSION


The objective is to evaluate the possibility to reduce the incisional hernia rate in patients undergoing urgent/emergent laparotomy in contaminated/infected field with peritonitis by using swine dermal collagen prosthesis preperitoneal positioning as a prophylactic procedure.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04681326. Registered (retrospectively after first patient recruited) on 23 December 2020.",2022,The evaluation of quality of life of patients with incisional hernia showed lower mean scores on physical components of health-related quality of life and body image.,"['Patients undergoing emergency surgery for peritonitis', 'patients operated with contaminated/infected field in peritonitis', '90 patients divided in two arms', 'patients with incisional hernia', 'patients undergoing urgent/emergent laparotomy in contaminated/infected field with peritonitis by using', 'peritonitis (PROPHYBIOM']","['PROPHYlactic Implantation of BIOlogic Mesh', 'swine dermal collagen prosthesis implanted preperitoneally', 'swine dermal collagen prosthesis preperitoneal positioning', 'prosthesis positioning versus normal wall abdominal closure']","['percentage of incisional hernias, wound infections, and adverse events', 'morbidity and mortality rates and prolongs the hospitalization', 'risk of incisional hernia (IH', 'incisional hernia rate', 'physical components of health-related quality of life and body image']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]",,0.169499,The evaluation of quality of life of patients with incisional hernia showed lower mean scores on physical components of health-related quality of life and body image.,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Coccolini', 'Affiliation': 'General Emergency and Trauma Surgery, Pisa University Hospital, Pisa, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tarasconi', 'Affiliation': 'Emergency Surgery Department, Parma University Hospital, Parma, Italy.'}, {'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Petracca', 'Affiliation': 'Emergency Surgery Department, Parma University Hospital, Parma, Italy. glpetracca@gmail.com.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Perrone', 'Affiliation': 'Emergency Surgery Department, Parma University Hospital, Parma, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Giuffrida', 'Affiliation': 'Emergency Surgery Department, Parma University Hospital, Parma, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Disisto', 'Affiliation': 'Emergency Surgery Department, Parma University Hospital, Parma, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sartelli', 'Affiliation': 'Department of Surgery, Macerata Hospital, Macerata, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Carcoforo', 'Affiliation': 'Department of Surgery, S. Anna University Hospital and University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ansaloni', 'Affiliation': 'General Surgery, Pavia University Hospital, Pavia, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Catena', 'Affiliation': 'Emergency Surgery Department, Parma University Hospital, Parma, Italy.'}]",Trials,['10.1186/s13063-022-06103-4']
3408,35246028,Influence of cardiopulmonary exercise test on platelet function in patients with coronary artery diseases on antiplatelet therapy.,"BACKGROUND


Cardiac rehabilitation reduces mortality and morbidity rate of patients with coronary artery diseases (CAD); however, acute exercise stimulation may also increase the thrombotic risk through platelet activation. Studies on the effects of cardiac rehabilitation on platelet function have been sparse.
METHODS


A total of 28 patients (24 men and 4 women; average age = 54.6 ± 8 years old) with stable CAD were enrolled in this study and divided into Aspirin-treated (n = 11; Aspirin group) and dual-antiplatelet-treated group (DAPT group; n = 17). Symptom-limited cardiopulmonary exercise test (CPET) with a cycle ergometer was performed on all the patients. Before and after CPET, platelet function was evaluated using light transmission aggregometry and whole blood flow cytometry.
RESULTS


All patients completed the CPET without provoked cardiac events, and the mean value of peak oxygen uptake (Peak Vo 2 ) was 19.3 ± 3 ml/(kg min). Prior to CPET, platelet aggregation was significantly suppressed in DAPT group compared to Aspirin group (43.0 ± 21.5 vs. 72.9 ± 7.5, p < 0.001). CPET promoted platelet aggregation in Aspirin group (72.9 ± 7.5 vs. 80.9 ± 7.6, p = 0.005) and DAPT group (43.0 ± 21.5 vs. 50.1 ± 20.9, p = 0.010), and platelet count was increased in Aspirin (210.9 ± 54.6 vs. 227.5 ± 58.1, p = 0.001) and DAPT group (217.5 ± 63.8 vs. 229.7 ± 63.7, p = 0.001). However, the expression levels of CD62p and PAC-1 were not affected by CPET in both groups.
CONCLUSION


Symptom-limited CPET enhanced platelet aggregation in patients with CAD despite treatment with antiplatelet, mainly via platelet count augmentation, but not through single platelet activation.
TRIAL REGISTRATION


Effects of high intensity interval training versus moderate intensity continue training in cardiac rehabilitation on platelet function of patients with coronary heart diseases: a exploratory randomized controlled trial. ChiCTR-INR-17010717. Registered 23 February 2017, https://www.chictr.org.cn/edit.aspx?pid=18206&htm=4 .",2022,"CPET promoted platelet aggregation in Aspirin group (72.9 ± 7.5 vs. 80.9 ± 7.6, p = 0.005) and DAPT group (43.0 ± 21.5 vs. 50.1 ± 20.9, p = 0.010), and platelet count was increased in Aspirin (210.9 ± 54.6 vs. 227.5 ± 58.1, p = 0.001) and DAPT group (217.5 ± 63.8 vs. 229.7 ± 63.7, p = 0.001).","['patients with coronary heart diseases', 'patients with coronary artery diseases on antiplatelet therapy', 'patients with coronary artery diseases (CAD', 'patients with CAD', '28 patients (24 men and 4 women; average age\u2009=\u200954.6\u2009±\u20098\xa0years old) with stable CAD']","['DAPT', 'cardiopulmonary exercise test', 'Symptom-limited cardiopulmonary exercise test (CPET', 'Aspirin-treated (n\u2009=\u200911; Aspirin group) and dual-antiplatelet-treated group (DAPT group; n\u2009=\u200917', 'Aspirin', 'high intensity interval training versus moderate intensity continue training', 'cardiac rehabilitation']","['mortality and morbidity rate', 'mean value of peak oxygen uptake', 'platelet count', 'CPET without provoked cardiac events', 'platelet aggregation', 'expression levels of CD62p and PAC-1', 'platelet function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}]",28.0,0.0259207,"CPET promoted platelet aggregation in Aspirin group (72.9 ± 7.5 vs. 80.9 ± 7.6, p = 0.005) and DAPT group (43.0 ± 21.5 vs. 50.1 ± 20.9, p = 0.010), and platelet count was increased in Aspirin (210.9 ± 54.6 vs. 227.5 ± 58.1, p = 0.001) and DAPT group (217.5 ± 63.8 vs. 229.7 ± 63.7, p = 0.001).","[{'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Yin', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Chongqing Medical University, No. 1, Youyi Road, Yuzhong District, Chongqing, 400016, China.'}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Cardiac Rehabilitation Center, Beijing First Hospital of Integrated Chinese and Western Medicine, Beijing, 100026, China.'}, {'ForeName': 'Chunhua', 'Initials': 'C', 'LastName': 'Mo', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Chongqing Medical University, No. 1, Youyi Road, Yuzhong District, Chongqing, 400016, China.'}, {'ForeName': 'Zong', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': 'Cardiac Rehabilitation Center, Beijing First Hospital of Integrated Chinese and Western Medicine, Beijing, 100026, China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, China-Japan Friendship Hospital, Beijing, 100029, China.'}, {'ForeName': 'Dayi', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Chongqing Medical University, No. 1, Youyi Road, Yuzhong District, Chongqing, 400016, China. Dayi_hu@sina.cn.'}]",BMC cardiovascular disorders,['10.1186/s12872-022-02486-z']
3409,35246426,"Selumetinib in combination with dexamethasone for the treatment of relapsed/refractory RAS-pathway mutated paediatric and adult acute lymphoblastic leukaemia (SeluDex): study protocol for an international, parallel-group, dose-finding with expansion phase I/II trial.","INTRODUCTION


Event-free survival rates at 15 years for paediatric patients with relapsed/refractory acute lymphoblastic leukaemia (ALL) are 30%-50%, with 5-year survival for adult patients only 20%. Many patients with newly diagnosed and relapsed ALL harbour somatic RAS-signalling activation mutations. Induction therapy for ALL involves steroids, with preclinical data suggesting the combination of dexamethasone with the MEK1/2 inhibitor, selumetinib (ARRY-142886) has a synergistic anticancer effect.
METHODS AND ANALYSIS


The SeluDex trial is an international, parallel-group, dose-finding with expansion, phase I/II trial to assess the selumetinib/dexamethasone combination in adult and paediatric patients with relapsed/refractory, RAS pathway mutant ALL. The Cancer Research UK Clinical Trials Unit at University of Birmingham is the UK Coordinating Centre, with national hubs in Copenhagen, Denmark; Monza, Italy; Münster, Germany; Paris, France; and Utrecht, Netherlands. Patients with morphologically proven relapsed/refractory or progressive B-cell precursor or T-cell ALL, with demonstrated RAS pathway activating mutations are eligible. Adult patients are  > 18 years old, ECOG  < 2 and paediatric <18 years old, Lansky play scale ≥60% or Karnofsky score ≥60%. Phase I primary objective is the recommended phase II dose of selumetinib as defined by occurrence/non-occurrence of dose limiting toxicities using the continual reassessment method; phase II will evaluate preliminary antileukaemic activity of the combination, as defined by morphological response 28 days post-treatment using a Bayesian approach. Target recruitment is between 26 and 42 patients (minimum 13 and maximum 21 per group), depending the number of phase I patients included in phase II.
ETHICS AND DISSEMINATION


Medical ethical committees of all the participating countries have approved the study protocol; initial (UK) ethics approval (17/YH/0123) was granted by Yorkshire & The Humber-Leeds West Research Ethics Committee. Participants are required to provide written informed consent/assent. Results will be disseminated through national and international presentations and peer-reviewed publications.
TRIAL REGISTRATION NUMBER


ISRCTN92323261.",2022,"INTRODUCTION


Event-free survival rates at 15 years for paediatric patients with relapsed/refractory acute lymphoblastic leukaemia (ALL) are 30%-50%, with 5-year survival for adult patients only 20%.","['relapsed/refractory RAS-pathway mutated paediatric and adult acute lymphoblastic leukaemia (SeluDex', 'Many patients with newly diagnosed and relapsed ALL harbour somatic RAS-signalling activation mutations', 'Patients with morphologically proven relapsed/refractory or progressive B-cell precursor or T-cell ALL, with demonstrated RAS pathway activating mutations are eligible', 'Adult patients are  > 18 years old, ECOG  < 2\u2009and paediatric <18 years old, Lansky play scale ≥60%\u2009or Karnofsky score ≥60', 'paediatric patients with relapsed/refractory acute lymphoblastic leukaemia (ALL', 'adult and paediatric patients with relapsed/refractory, RAS pathway mutant ALL']","['dexamethasone', 'selumetinib/dexamethasone combination', 'Selumetinib']","['survival rates', '5-year survival']","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C4505109', 'cui_str': 'Activation Mutation'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C1961099', 'cui_str': 'T-cell acute lymphoblastic leukemia'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.202665,"INTRODUCTION


Event-free survival rates at 15 years for paediatric patients with relapsed/refractory acute lymphoblastic leukaemia (ALL) are 30%-50%, with 5-year survival for adult patients only 20%.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Menne', 'Affiliation': 'Northern Center for Cancer Care, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Slade', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomics Cancer, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Savage', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomics Cancer, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomics Cancer, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Irving', 'Affiliation': 'Wolfson Childhood Cancer Research Centre, Newcastle University Centre for Cancer, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Kearns', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomics Cancer, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Plummer', 'Affiliation': 'Northern Center for Cancer Care, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Shenton', 'Affiliation': ""Great North Children's Hospital, Royal Victoria Infirmary Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Veal', 'Affiliation': 'Wolfson Childhood Cancer Research Centre, Newcastle University Centre for Cancer, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Vormoor', 'Affiliation': 'Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Vormoor', 'Affiliation': 'Wolfson Childhood Cancer Research Centre, Newcastle University Centre for Cancer, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Billingham', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomics Cancer, University of Birmingham, Birmingham, UK l.j.billingham@bham.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2021-059872']
3410,35246425,Effectiveness and cost-effectiveness of a combined lifestyle intervention compared with usual care for patients with early-stage knee osteoarthritis who are overweight (LITE): protocol for a randomised controlled trial.,"INTRODUCTION


Obesity is the most important modifiable risk factor for knee osteoarthritis (KOA). Especially in an early stage of the disease, weight loss is important to prevent further clinical and structural progression. Since 2019, general practitioners (GPs) in the Netherlands can refer eligible patients to a combined lifestyle intervention (GLI) to promote physical activity, healthy nutrition and behavioural change. However, GPs scarcely refer patients with KOA to the GLI potentially due to a lack of evidence about the (cost-)effectiveness. The aim of this study is to determine the (cost-)effectiveness of the GLI for patients with early-stage KOA in primary care.
METHODS AND ANALYSIS


For this pragmatic, multi-centre randomised controlled trial, 234 participants (aged 45-70 years) with National Institute for Health and Care Excellence (NICE) guideline diagnosis of clinical KOA and a body mass index above 25 kg/m 2  will be recruited using a range of online and offline strategies and from general practices in the Netherlands. Participants will receive nine 3-monthly questionnaires. In addition, participants will be invited for a physical examination, MRI assessment and blood collection at baseline and at 24-month follow-up. After the baseline assessment, participants are randomised to receive either the 24-month GLI programme in addition to usual care or usual care only. Primary outcomes are self-reported knee pain over 24 months, structural progression on MRI at 24 months, weight loss at 24 months, as well as societal costs and Quality-Adjusted Life-Years over 24-month follow-up. Analyses will be performed following the intention-to-treat principle using linear mixed-effects regression models.
ETHICS AND DISSEMINATION


Ethical approval was obtained through the Medical Ethical Committee of the Erasmus MC University Medical Center Rotterdam, The Netherlands (MEC-2020-0943). All participants will provide written informed consent. The results will be disseminated through publications in peer-reviewed journals, presentations at international conferences and among study participants and healthcare professionals.
TRIAL REGISTRATION NUMBER


Netherlands Trial Registry (NL9355).",2022,"After the baseline assessment, participants are randomised to receive either the 24-month GLI programme in addition to usual care or usual care only.","['234 participants (aged 45-70 years) with National Institute for Health and Care Excellence (NICE) guideline diagnosis of clinical KOA and a body mass index above 25 kg/m 2  will be recruited using a range of online and offline strategies and from general practices in the Netherlands', 'patients with early-stage knee osteoarthritis who are overweight (LITE', 'patients with early-stage KOA in primary care']","['usual care', 'combined lifestyle intervention (GLI', 'combined lifestyle intervention', 'GLI programme in addition to usual care or usual care only']","['self-reported knee pain over 24 months, structural progression on MRI at 24 months, weight loss at 24 months, as well as societal costs and Quality-Adjusted Life-Years', 'Effectiveness and cost-effectiveness']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1449308', 'cui_str': 'GLI1 protein, human'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",234.0,0.254273,"After the baseline assessment, participants are randomised to receive either the 24-month GLI programme in addition to usual care or usual care only.","[{'ForeName': 'Nuria E J', 'Initials': 'NEJ', 'LastName': 'Jansen', 'Affiliation': 'Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands n.jansen@erasmusmc.nl.'}, {'ForeName': 'Dieuwke', 'Initials': 'D', 'LastName': 'Schiphof', 'Affiliation': 'Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Oei', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jolande', 'Initials': 'J', 'LastName': 'van Teeffelen', 'Affiliation': 'Dietician Practice in Primary Care, Diëtistenpraktijk HRC, Rotterdam, The Netherlands.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Feleus', 'Affiliation': 'Research Center Innovations in Care, Rotterdam University of Applied Sciences, Rotterdam, The Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Runhaar', 'Affiliation': 'Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'van Meurs', 'Affiliation': 'Department of Internal Medicine, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Sita M A', 'Initials': 'SMA', 'LastName': 'Bierma-Zeinstra', 'Affiliation': 'Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Marienke', 'Initials': 'M', 'LastName': 'van Middelkoop', 'Affiliation': 'Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2021-059554']
3411,35246418,Disease progression in osteosarcoma: a multistate model for the EURAMOS-1 (European and American Osteosarcoma Study) randomised clinical trial.,"OBJECTIVES


Investigating the effect of prognostic factors in a multistate framework on survival in a large population of patients with osteosarcoma. Of interest is how prognostic factors affect different disease stages after surgery, with stages of local recurrence (LR), new metastatic disease (NM), LR+NM, secondary malignancy, a second NM, and death.
DESIGN


An open-label, international, phase 3 randomised controlled trial.
SETTING


325 sites in 17 countries.
PARTICIPANTS


The subset of 1631 metastases-free patients from 1965 patients with high-grade resectable osteosarcoma, from the European and American Osteosarcoma Study.
MAIN OUTCOME MEASURES


The effect of prognostic factors on different disease stages, expressed as HRs; predictions of disease progression on an individual patient basis, according to patient-specific characteristics and history of intermediate events.
RESULTS


Of 1631 patients, 526 experienced an intermediate event, and 305 died by the end of follow-up. An axial tumour site substantially increased the risk of LR after surgery (HR=10.84, 95% CI 8.46 to 13.86) and death after LR (HR=11.54, 95% CI 6.11 to 21.8). A poor histological increased the risk of NM (HR=5.81, 95% CI 5.31 to 6.36), which sharply declined after 3 years since surgery. Young patients (<12 years) had a lower intermediate event risk (eg, for LR: HR=0.66, 95% CI 0.51 to 0.86), when compared with adolescents (12-18 years), but had an increased risk of subsequent death, while patients aged >18 had a decreased risk of death after event (eg, for death after LR: HR=2.40, 95% CI 1.52 to 3.90; HR=0.35, 95% CI 0.21 to 0.56, respectively).
CONCLUSIONS


Our findings suggest that patients with axial tumours should be monitored for LR and patients with poor histological response for NM, and that for young patients (<12) with an LR additional treatment options should be investigated.
TRIAL REGISTRATION NUMBER


NCT00134030.",2022,"A poor histological increased the risk of NM (HR=5.81, 95% CI 5.31 to 6.36), which sharply declined after 3 years since surgery.","['325 sites in 17 countries', 'Disease progression in osteosarcoma', 'patients with osteosarcoma', 'patients with axial tumours', 'The subset of 1631 metastases-free patients from 1965 patients with high-grade resectable osteosarcoma, from the European and American Osteosarcoma Study', '1631 patients']",[],"['risk of LR', 'risk of subsequent death', 'death after LR', 'risk of death after event (eg, for death after LR', 'risk of NM']","[{'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.405558,"A poor histological increased the risk of NM (HR=5.81, 95% CI 5.31 to 6.36), which sharply declined after 3 years since surgery.","[{'ForeName': 'Audinga-Dea', 'Initials': 'AD', 'LastName': 'Hazewinkel', 'Affiliation': 'MRC Integrative Epidemiology Unit, Bristol Medical School, University of Bristol, Bristol, UK a.d.hazewinkel@bristol.ac.uk.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Lancia', 'Affiliation': 'Mathematical Institute, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Anninga', 'Affiliation': 'Department of Solid Tumours, Princess Máxima Centre, Utrecht, Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'van de Sande', 'Affiliation': 'Department of Orthopaedics, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Whelan', 'Affiliation': 'Cancer Institute, Faculty of Medical Sciences, University College London, London, UK.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Fiocco', 'Affiliation': 'Department of Biomedical Data Science, Leiden University Medical Center, Leiden, Netherlands.'}]",BMJ open,['10.1136/bmjopen-2021-053083']
3412,35246227,LIBERATE: a study protocol for midodrine for the early liberation from vasopressor support in the intensive care unit (LIBERATE): protocol for a randomized controlled trial.,"BACKGROUND


Intravenous (IV) vasopressors to support hemodynamics are a primary indication for intensive care unit (ICU) admission. Utilization of oral vasopressor therapy may offer an alternative to IV vasopressor therapy in the ICU, thus decreasing the need for ICU admission. Oral vasopressors, such as midodrine, have been used for hemodynamic support in non-critically ill patients, but their evaluation in critically ill patients to potentially spare IV vasopressor therapy has been limited.
METHODS


The LIBERATE study will be a multicenter, parallel-group, blinded, randomized placebo-controlled trial. It will recruit adult (i.e., age ≥ 18 years) critically ill patients receiving stable or decreasing doses of IV vasopressors. Eligible patients will be randomized to receive either midodrine 10 mg administered enterally every 8 h or placebo until 24 h post-discontinuation of IV vasopressors. The primary outcome will be ICU length of stay. Secondary outcomes include all-cause mortality at 90 days, hospital length of stay, length of IV vasopressor support, re-initiation of IV vasopressors, rates of ICU readmission, and occurrence of AEs. Health economic outcomes including ICU, hospital and healthcare costs, and cost-effectiveness will be evaluated. Pre-planned subgroup analyses include age, sex, frailty, severity of illness, etiology of shock, and comorbid conditions.
DISCUSSION


LIBERATE will rigorously evaluate the effect of oral midodrine on duration of ICU stay and IV vasopressor support in critically ill patients.
TRIAL REGISTRATION


ClinicalTrials.gov NCT05058612 . Registered on September 28, 2021.",2022,"Pre-planned subgroup analyses include age, sex, frailty, severity of illness, etiology of shock, and comorbid conditions.
","['critically ill patients', 'Eligible patients', 'adult (i.e., age\u2009≥\u200918\u2009years) critically ill patients receiving stable or decreasing doses of IV vasopressors']","['oral vasopressor therapy', 'placebo', 'midodrine 10\u2009mg administered enterally every 8\u2009h or placebo']","['ICU, hospital and healthcare costs, and cost-effectiveness', 'duration of ICU stay and IV vasopressor support', 'cause mortality at 90\u2009days, hospital length of stay, length of IV vasopressor support, re-initiation of IV vasopressors, rates of ICU readmission, and occurrence of AEs', 'ICU length of stay']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026078', 'cui_str': 'Midodrine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",,0.479026,"Pre-planned subgroup analyses include age, sex, frailty, severity of illness, etiology of shock, and comorbid conditions.
","[{'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Opgenorth', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Baig', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fiest', 'Affiliation': 'Department of Critical Care Medicine, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Karvellas', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Kutsogiannis', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Lau', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Macintyre', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Janek', 'Initials': 'J', 'LastName': 'Senaratne', 'Affiliation': ''}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Slemko', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Sligl', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Alberta Health Services, Edmonton, Canada.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Bagshaw', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Oleksa G', 'Initials': 'OG', 'LastName': 'Rewa', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada. rewa@ualberta.ca.'}]",Trials,['10.1186/s13063-022-06115-0']
3413,35246219,A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design.,"BACKGROUND


Elevated body mass index (BMI) represents a risk factor for cancer-related fatigue (CRF). Weight loss interventions are feasible and safe in cancer survivors, leading to improved cardio-metabolic and quality of life (QOL) outcomes and modulating inflammatory biomarkers. Randomized data are lacking showing that a lifestyle intervention aimed at weight loss, combining improved diet, exercise, and motivational counseling, reduces CRF. Motivating to Exercise and Diet, and Educating to healthy behaviors After breast cancer (MEDEA) is a multi-center, randomized controlled trial evaluating the impact of weight loss on CRF in overweight or obese survivors of breast cancer. Herein, we described the MEDEA methodology.
METHODS


Patients (N = 220) with stage I-III breast cancer and BMI ≥ 25 kg/m 2 , within 12 months of primary treatment, and able to walk ≥ 400 m are eligible to enroll. Participants are randomized 1:1 to health education alone vs. a personalized telephone-based weight loss intervention plus health education. Both arms receive a health education program focusing on healthy living. Patients in the intervention arm are paired with an individual lifestyle coach, who delivers the intervention through 24 semi-structured telephone calls over 1 year. Intervention goals include weight loss ≥ 10% of baseline, caloric restriction of 500-1000 Kcal/day, and increased physical activity (PA) to 150 (initial phase) and 225-300 min/week (maintenance phase). The intervention is based on the social cognitive theory and is adapted from the Breast Cancer Weight Loss trial (BWEL, A011401). The primary endpoint is the difference in self-reported CRF (EORTC QLQ-C30) between arms. Secondary endpoints include the following: QOL (EORTC QLQ-C30, -BR45, -FA12), anxiety, and depression (HADS); weight and BMI, dietary habits and quality, PA, and sleep; health care costs (hospital-admissions, all-drug consumption, sick leaves) and cost-effectiveness (cost per quality-adjusted life-year); and patient motivation and satisfaction. The primary analysis of MEDEA will compare self-reported CRF at 12 months post-randomization between arms, with 80.0% power (two-sided α = 0.05) to detect a standardized effect size of 0.40.
DISCUSSION


MEDEA will test the impact of a weight loss intervention on CRF among overweight or obese BC survivors, potentially providing additional management strategies and contributing to establish weight loss support as a new standard of clinical care.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04304924.",2022,The primary endpoint is the difference in self-reported CRF (EORTC QLQ-C30) between arms.,"['overweight and obese breast cancer patients', 'Patients (N = 220)\xa0with stage I-III breast cancer and BMI ≥ 25\u2009kg/m 2', 'CRF among overweight or obese BC survivors', 'overweight or obese survivors\xa0of breast cancer']","['weight loss', 'Weight loss interventions', 'individual lifestyle coach, who delivers the intervention through 24 semi-structured telephone calls over 1\u2009year', 'health education alone vs. a personalized telephone-based weight loss intervention plus health education', 'health education program', 'Motivating to Exercise and Diet, and Educating to healthy behaviors']","['weight loss ≥ 10% of baseline, caloric restriction of 500-1000 Kcal/day, and\xa0increased physical activity (PA', 'the following: QOL (EORTC QLQ-C30, -BR45, -FA12), anxiety, and depression (HADS); weight and BMI, dietary habits and quality, PA, and sleep; health care costs (hospital-admissions, all-drug consumption, sick leaves) and cost-effectiveness (cost per quality-adjusted life-year); and patient motivation and satisfaction', 'difference in self-reported CRF (EORTC QLQ-C30', 'cardio-metabolic and quality of life (QOL) outcomes']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.122669,The primary endpoint is the difference in self-reported CRF (EORTC QLQ-C30) between arms.,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Di Meglio', 'Affiliation': 'INSERM Unit 981-Molecular Predictors and New Targets in Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Martin', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Crane', 'Affiliation': 'University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Charles', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Barbier', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Raynard', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mangin', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Tredan', 'Affiliation': 'Centre Léon Berard, Lyon, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Bouleuc', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Cottu', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Vanlemmens', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Segura-Djezzar', 'Affiliation': 'Centre François Baclesse, Caen, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lesur', 'Affiliation': 'Institut de cancérologie de Lorraine, Nancy, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pistilli', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Centre François Baclesse, Caen, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ginsbourger', 'Affiliation': 'CAMI Sport & Cancer, Paris, France.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Coquet', 'Affiliation': 'Ligue contre le cancer-France, Paris, France.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Pauporte', 'Affiliation': 'Ligue contre le cancer-France, Paris, France.'}, {'ForeName': 'Guillemette', 'Initials': 'G', 'LastName': 'Jacob', 'Affiliation': 'Seintinelles, Paris, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Sirven', 'Affiliation': 'UNICANCER, Paris, France.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bonastre', 'Affiliation': ""Service de Biostatistique et d'Epidémiologie, Gustave Roussy, Oncostat U1018, Inserm, University Paris-Saclay, Equipe labellisee Ligue Contre le Cancer, Villejuif, France.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Ligibel', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Michiels', 'Affiliation': ""Service de Biostatistique et d'Epidémiologie, Gustave Roussy, Oncostat U1018, Inserm, University Paris-Saclay, Equipe labellisee Ligue Contre le Cancer, Villejuif, France.""}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Vaz-Luis', 'Affiliation': 'INSERM Unit 981-Molecular Predictors and New Targets in Oncology, Gustave Roussy, Villejuif, France. INES-MARIA.VAZ-DUARTE-LUIS@gustaveroussy.fr.'}]",Trials,['10.1186/s13063-022-06090-6']
3414,35246214,Prospective preference assessment for the Comparison of Analgesic Regimen Effectiveness and Safety in Surgery (CARES) trial.,"BACKGROUND


Clinical trials face major barriers such as under-enrollment and selective enrollment, which threaten study completion and undermine validity and generalizability. Thus, we conducted a prospective preference assessment (PPA) prior to commencing the Comparison of Analgesic Regimen Effectiveness and Safety in Surgery (CARES) trial-a randomized controlled study comparing the outcomes of managing acute postoperative pain between opioid-sparing and opioid-based therapies. This PPA aimed to (1) determine the patients' willingness to participate in the CARES trial, (2) identify the areas for improvement, and (3) assess the differences between willing and unwilling patients.
METHODS


Patients undergoing elective laparoscopic cholecystectomy were recruited between August 2019 and February 2020 from two academic hospitals. A survey was administered to each patient consisting of (1) a vignette describing the trial, (2) an assessment of the patients' understanding of the trial, (3) open-ended questions assessing the attitudes towards the trial, and (4) patient-completed questionnaires. Data were analyzed qualitatively with thematic analysis and quantitatively with the Wilcoxon signed-rank and chi-square tests.
RESULTS


Forty-two patients were enrolled and grouped based on the 6-point Likert scale into willing (4-6, 71%) and not willing (1-3, 29%) to participate in the CARES trial. There were no significant differences with respect to all variables: age, education, sex, visible minority status, previous research, previous surgery, regular use of pain medications, surgical concerns, previous discussions on pain management, significant pain within the past 3 months, and significant use of pain medication within the past month. Factors that motivated participation were contributing to scientific research (45%), altruism (29%), and improving personal pain (24%). Common discouraging factors were negative perceptions of opioids (29%), side effects (21%), being blinded to the study medication (21%), and poor pain management (19%).
CONCLUSIONS


This PPA revealed that two key discouraging factors for patients were being blinded to the type of pain medication being taken and the potential for poor pain management as a consequence of participation. Modifications to improve patient acceptance of the CARES trial include ensuring sufficient rescue medicine and follow-up visits consistent with current standards of care for all patients, as well as patient education surrounding safe administration and side effects of the study medications.",2022,"There were no significant differences with respect to all variables: age, education, sex, visible minority status, previous research, previous surgery, regular use of pain medications, surgical concerns, previous discussions on pain management, significant pain within the past 3 months, and significant use of pain medication within the past month.","['Patients undergoing elective laparoscopic cholecystectomy were recruited between August 2019 and February 2020 from two academic hospitals', 'Forty-two patients were enrolled and grouped based on the 6-point Likert scale into willing (4-6, 71%) and not willing (1-3, 29%) to participate in the CARES trial']",['opioid-sparing and opioid-based therapies'],"['side effects', 'pain medication', 'poor pain management', 'pain management, significant pain', 'personal pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",42.0,0.0614679,"There were no significant differences with respect to all variables: age, education, sex, visible minority status, previous research, previous surgery, regular use of pain medications, surgical concerns, previous discussions on pain management, significant pain within the past 3 months, and significant use of pain medication within the past month.","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hyung', 'Affiliation': 'Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Bicket', 'Affiliation': 'Department of Anesthesiology, University of Michigan School of Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Brull', 'Affiliation': 'Department of Anesthesiology and Pain Management, Department of Anesthesia, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Janneth', 'Initials': 'J', 'LastName': 'Pazmino-Canizares', 'Affiliation': ""Department of Anesthesia, St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Didem', 'Initials': 'D', 'LastName': 'Bozak', 'Affiliation': 'Department of Anesthesiology and Pain Management, Department of Anesthesia, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Karim S', 'Initials': 'KS', 'LastName': 'Ladha', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, ON, Canada. karim.ladha@mail.utoronto.ca.'}]",Trials,['10.1186/s13063-022-06123-0']
3415,35246620,"Safety and efficacy of transcranial direct current stimulation in upper extremity rehabilitation after tetraplegia: protocol of a multicenter randomized, clinical trial.","STUDY DESIGN


A multisite, randomized, controlled, double-blinded phase I/II clinical trial.
OBJECTIVE


The purpose of this clinical trial is to evaluate the safety, feasibility and efficacy of pairing noninvasive transcranial direct current stimulation (tDCS) with rehabilitation to promote paretic upper extremity recovery and functional independence in persons living with chronic cervical spinal cord injury (SCI).
SETTING


Four-site trial conducted across Cleveland Clinic, Louis Stokes Veterans Affairs Medical Center of Cleveland and MetroHealth Rehabilitation Rehabilitation Institute of Ohio, and Kessler Foundation of New Jersey.
METHODS


Forty-four adults (age ≥18 years) with tetraplegia following cervical SCI that occurred ≥1-year ago will participate. Participants will be randomly assigned to receive anodal tDCS or sham tDCS given in combination with upper extremity rehabilitation for 15 sessions each over 3-5 weeks. Assessments will be made twice at baseline separated by at least a 3-week interval, once at end-of-intervention, and once at 3-month follow-up.
PRIMARY OUTCOME MEASURE(S)


Primary outcome measure is upper extremity motor impairment assessed using the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) scale. Functional abilities will be assessed using Capabilities of Upper Extremity-Test (CUE-T), while functional independence and participation restrictions will be evaluated using the self-care domain of Spinal Cord Independent Measure (SCIM), and Canadian Occupational Performance Measure (COPM).
SECONDARY OUTCOME MEASURES


Treatment-associated change in corticospinal excitability and output will also be studied using transcranial magnetic stimulation (TMS) and safety (reports of adverse events) and feasibility (attrition, adherence etc.) will also be evaluated.
TRIAL REGISTRATION


ClincalTrials.gov identifier NCT03892746. This clinical trial is being performed at four sites within the United States: Cleveland Clinic (lead site), Louis Stokes Cleveland Veterans Affairs Medical Center (VAMC) and MetroHealth Rehabilitation Institute in Ohio, and Kessler Foundation in New Jersey. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office.",2022,"The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office.","['Four-site trial conducted across Cleveland Clinic, Louis Stokes Veterans Affairs Medical Center of Cleveland and MetroHealth Rehabilitation Rehabilitation Institute of Ohio, and Kessler Foundation of New Jersey', 'Forty-four adults (age ≥18 years) with tetraplegia following cervical SCI that occurred ≥1-year ago will participate', 'persons living with chronic cervical spinal cord injury (SCI', 'upper extremity rehabilitation after tetraplegia', 'four sites within the United States: Cleveland Clinic (lead site), Louis Stokes Cleveland Veterans Affairs Medical Center (VAMC) and MetroHealth Rehabilitation Institute in Ohio, and Kessler Foundation in New Jersey']","['pairing noninvasive transcranial direct current stimulation (tDCS) with rehabilitation', 'transcranial direct current stimulation', 'anodal tDCS or sham tDCS given in combination with upper extremity rehabilitation']","['Safety and efficacy', 'upper extremity motor impairment assessed using the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) scale', 'corticospinal excitability and output will also be studied using transcranial magnetic stimulation (TMS) and safety (reports of adverse events) and feasibility (attrition, adherence etc', 'self-care domain of Spinal Cord Independent Measure (SCIM), and Canadian Occupational Performance Measure (COPM']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0027971', 'cui_str': 'New Jersey'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034372', 'cui_str': 'Tetraplegia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0003023', 'cui_str': 'Angola'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}]",44.0,0.187124,"The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office.","[{'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Arora', 'Affiliation': 'Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': ""O'Laughlin"", 'Affiliation': 'Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Potter-Baker', 'Affiliation': 'Department of Neuroscience, School of Medicine, University of Texas RioGrande Valley, RioGrande Valley, TX, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kirshblum', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kilgore', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MetroHealth System, Cleveland, OH, USA.'}, {'ForeName': 'Gail F', 'Initials': 'GF', 'LastName': 'Forrest', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Bryden', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MetroHealth System, Cleveland, OH, USA.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, OH, USA.'}, {'ForeName': 'M Kristi', 'Initials': 'MK', 'LastName': 'Henzel', 'Affiliation': 'Louis Stokes Veterans Affairs (VA) Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Manshi', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, OH, USA.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Perlic', 'Affiliation': 'Therapy Services, Neurological Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Richmond', 'Affiliation': 'Louis Stokes Veterans Affairs (VA) Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Pundik', 'Affiliation': 'Louis Stokes Veterans Affairs (VA) Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Bethoux', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Neurological Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Frost', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Neurological Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.'}, {'ForeName': 'Ela B', 'Initials': 'EB', 'LastName': 'Plow', 'Affiliation': 'Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, OH, USA. plowe2@ccf.org.'}]",Spinal cord,['10.1038/s41393-022-00768-z']
3416,35246723,Pulmonary artery sensor system pressure monitoring to improve heart failure outcomes (PASSPORT-HF): rationale and design of the PASSPORT-HF multicenter randomized clinical trial.,"BACKGROUND


Remote monitoring of patients with New York Heart Association (NYHA) functional class III heart failure (HF) using daily transmission of pulmonary artery (PA) pressure values has shown a reduction in HF-related hospitalizations and improved quality of life in patients.
OBJECTIVES


PASSPORT-HF is a prospective, randomized, open, multicenter trial evaluating the effects of a hemodynamic-guided, HF nurse-led care approach using the CardioMEMS™ HF-System on clinical end points.
METHODS AND RESULTS


The PASSPORT-HF trial has been commissioned by the German Federal Joint Committee (G-BA) to ascertain the efficacy of PA pressure-guided remote care in the German health-care system. PASSPORT-HF includes adult HF patients in NYHA functional class III, who experienced an HF-related hospitalization within the last 12 months. Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy. Patients will be randomized centrally 1:1 to implantation of a CardioMEMS™ sensor or control. All patients will receive post-discharge support facilitated by trained HF nurses providing structured telephone-based care. The trial will enroll 554 patients at about 50 study sites. The primary end point is a composite of the number of unplanned HF-related rehospitalizations or all-cause death after 12 months of follow-up, and all events will be adjudicated centrally. Secondary end points include device/system-related complications, components of the primary end point, days alive and out of hospital, disease-specific and generic health-related quality of life including their sub-scales, and laboratory parameters of organ damage and disease progression.
CONCLUSIONS


PASSPORT-HF will define the efficacy of implementing hemodynamic monitoring as a novel disease management tool in routine outpatient care.
TRIAL REGISTRATION


ClinicalTrials.gov; NCT04398654, 13-MAY-2020.",2022,"CONCLUSIONS


PASSPORT-HF will define the efficacy of implementing hemodynamic monitoring as a novel disease management tool in routine outpatient care.
","['554 patients at about 50 study sites', 'patients with New York Heart Association (NYHA) functional class III heart failure (HF']","['CardioMEMS™ sensor or control', 'hemodynamic-guided, HF nurse-led care approach', 'Pulmonary artery sensor system pressure monitoring']","['device/system-related complications, components of the primary end point, days alive and out of hospital, disease-specific and generic health-related quality of life including their sub-scales, and laboratory parameters of organ damage and disease progression', 'composite of the number of unplanned HF-related rehospitalizations or all-cause death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",554.0,0.16007,"CONCLUSIONS


PASSPORT-HF will define the efficacy of implementing hemodynamic monitoring as a novel disease management tool in routine outpatient care.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Störk', 'Affiliation': 'Comprehensive Heart Failure Center, University and University Hospital Würzburg, Am Schwarzenberg 15, 97078, Würzburg, Germany. Stoerk_S@ukw.de.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Bernhardt', 'Affiliation': 'Institut für Herzinfarktforschung (IHF GmbH), Ludwigshafen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Internal Medicine III, University Hospital, Saarland University, Homburg/Saar, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brachmann', 'Affiliation': 'Department of Internal Medicine II, Klinikum Coburg GmbH, Coburg, Germany.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Dagres', 'Affiliation': 'Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Frantz', 'Affiliation': 'Comprehensive Heart Failure Center, University and University Hospital Würzburg, Am Schwarzenberg 15, 97078, Würzburg, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Hindricks', 'Affiliation': 'Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Köhler', 'Affiliation': 'Center for Cardiovascular Telemedicine, Charité Universitätsmedizin Berlin, Campus Mitte, Berlin, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Institut für Herzinfarktforschung (IHF GmbH), Ludwigshafen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Rosenkranz', 'Affiliation': 'Ludwigshafen Hospital, Ludwigshafen, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Angermann', 'Affiliation': 'Comprehensive Heart Failure Center, University and University Hospital Würzburg, Am Schwarzenberg 15, 97078, Würzburg, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Aßmus', 'Affiliation': 'Department of Internal Medicine I, University Hospital Gießen and Marburg, Gießen, Germany.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-022-01987-3']
3417,35246717,Astodrimer sodium and bacterial vaginosis: a mini review.,"Bacterial vaginosis (BV) is the most common vaginal infection affecting women of childbearing age, and is associated with a substantial burden on women's physical, emotional, sexual and social lives, as well as being linked to a number of gynaecological and obstetrical complications and adverse pregnancy outcomes. Antibiotics, such as metronidazole or clindamycin, are recommended as first-line treatment for BV, but may be associated with antibiotic resistance, high rates of recurrence and poor patient treatment satisfaction. Astodrimer sodium gel is a novel, non-antibiotic treatment for BV that is not systemically absorbed. It prevents pathogenic bacteria from adhering to the vaginal wall, and disrupts and inhibits the formation of pathogenic bacterial biofilms. Clinical cure rates of 50-57% were observed in patients with BV treated with astodrimer sodium compared with 17-21% treated with placebo (p < 0.001) in Phase 3 trials. In a separate Phase 3 trial, recurrence of BV occurred in 44% of patients treated with astodrimer sodium compared with 54% of patients who received placebo (p = 0.015). Astodrimer sodium is well tolerated, with vulvovaginal candidosis being the only treatment-related adverse event reported to occur more often than with placebo. The availability of astodrimer sodium, a well-tolerated, convenient, non-antibiotic treatment for BV, represents significant progress in the treatment of this burdensome condition.",2022,Clinical cure rates of 50-57% were observed in patients with BV treated with astodrimer sodium compared with 17-21% treated with placebo (p < 0.001) in Phase 3 trials.,[],"['Astodrimer sodium gel', 'placebo', 'astodrimer sodium', 'Astodrimer sodium', 'metronidazole or clindamycin', 'Astodrimer sodium and bacterial vaginosis']","['recurrence of BV', 'Clinical cure rates']",[],"[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.0564408,Clinical cure rates of 50-57% were observed in patients with BV treated with astodrimer sodium compared with 17-21% treated with placebo (p < 0.001) in Phase 3 trials.,"[{'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Mendling', 'Affiliation': 'German Centre for Infections in Gynecology and Obstetrics at Landesfrauenklinik, Helios University Hospital Wuppertal, Heusnerstrasse 40, 42283, Wuppertal, Germany. w.mendling@t-online.de.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Holzgreve', 'Affiliation': 'Wolfgang Holzgreve, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-022-06429-z']
3418,35247167,A pilot randomised control trial of the efficacy of stability-based training with visualisation for people with chronic ankle instability.,"Chronic ankle instability (CAI) is associated with recurring symptoms that inhibit daily activity. Stability-based rehabilitative training is recommended for CAI. Visualisation (VIS) produces real-time feedback using motion capture and virtual reality. This pilot study aimed to determine the feasibility, adherence, safety, and efficacy of incorporating VIS into stability training for people with CAI. Efficacy was examined through effect of VIS training on dynamic stability, perception of stability, and rehabilitative experience. Individuals with CAI completed a 4-week stability-based training programme with VIS, or without visualisation (NO-VIS). Participants completed the Star Excursion Balance Test (SEBT) and Cumberland Ankle Instability Tool (CAIT) prior to, and after training. Enjoyment of training was recorded using the Physical Activity Enjoyment Scale (PACES-8). Of 17 participants (VIS = 10, NO-VIS = 7), there were 2 drop outs (VIS = 1, NO-VIS = 1). No adverse events were reported, and participant drop-out was due to injury unrelated to the study. The VIS group showed a significantly greater increase in average SEBT reach distance (d = 1.7, p = 0.02). No significant differences were reported for the CAIT or PACES-8. This study supports the feasibility and safety of stability-based training with VIS in those with CAI. The enhanced performance outcome on the SEBT suggests VIS may enhance stability-based training.",2022,"The VIS group showed a significantly greater increase in average SEBT reach distance (d = 1.7, p = 0.02).","['Chronic ankle instability (CAI', 'people with CAI', 'Individuals with CAI completed a', 'people with chronic ankle instability']","['VIS training', 'Stability-based rehabilitative training', 'VIS into stability training', 'stability-based training with visualisation', 'stability-based training with VIS', '4-week stability-based training programme with VIS, or without visualisation (NO-VIS']","['feasibility, adherence, safety, and efficacy', 'dynamic stability, perception of stability, and rehabilitative experience', 'adverse events', 'Physical Activity Enjoyment Scale (PACES-8', 'Star Excursion Balance Test (SEBT) and Cumberland Ankle Instability Tool (CAIT', 'average SEBT reach distance']","[{'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",17.0,0.0139772,"The VIS group showed a significantly greater increase in average SEBT reach distance (d = 1.7, p = 0.02).","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Forsyth', 'Affiliation': 'Faculty of Biomedical Engineering, University of Strathclyde, Glasgow, UK. lauren.forsyth@strath.ac.uk.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bonacci', 'Affiliation': 'Centre for Sports Research, School of Exercise and Nutrition Science, Deakin University, Geelong, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Childs', 'Affiliation': 'Faculty of Biomedical Engineering, University of Strathclyde, Glasgow, UK.'}]",Medical & biological engineering & computing,['10.1007/s11517-022-02533-z']
3419,35247147,Family support-based intervention using a mobile application provided by pharmacists for older adults with diabetes to improve glycaemic control: a randomised controlled trial.,"Background Family support is crucial in the care of older patients with diabetes. However, more information is needed to evaluate the potential benefits of family-based intervention through a mobile application by pharmacists in the older diabetes patients. Aim To evaluate the effectiveness of family support-based intervention via a mobile application by pharmacists on clinical outcomes, family behaviour, diabetes knowledge, self-management practices and medication adherence in older adults with type 2 diabetes. Method A randomised controlled trial was conducted in a hospital in the south of Thailand with 9 months of follow-up. Family members in the intervention group (n = 78) received diabetes educational courses and encouragement via a mobile application from pharmacists to help their older relatives with diabetes in self-management tasks. The control group received usual care (n = 79). Results As compared to baseline, significant improvements were observed in the intervention patients for glycosylated haemoglobin (HbA 1c ), blood pressure, family behaviour in diabetes care, diabetes knowledge, self-management practices and medication adherence (P < 0.001). The intervention group showed greater decline in HbA 1c  levels relative to the control group (- 0.97% vs. - 0.12%; P = 0.001). Significant differences between groups for changes in blood pressure levels including scores of family behaviour, diabetes knowledge, self-management and medication adherence were found (P ≤ 0.001), with the intervention group showing greater improvement. Conclusion Family support intervention via a mobile application by pharmacists is beneficial to diabetes care for older adults.Trial registration number: TCTR20200615001 (date 13 June 2020, retrospectively registered).",2022,"Significant differences between groups for changes in blood pressure levels including scores of family behaviour, diabetes knowledge, self-management and medication adherence were found (P ≤ 0.001), with the intervention group showing greater improvement.","['older adults with diabetes to improve glycaemic control', 'older patients with diabetes', 'older relatives with diabetes in self-management tasks', 'older adults with type 2 diabetes', 'older diabetes patients', 'older adults', 'hospital in the south of Thailand with 9\xa0months of follow-up']","['diabetes educational courses and encouragement via a mobile application from pharmacists', 'usual care', 'family support-based intervention via a mobile application by pharmacists']","['glycosylated haemoglobin (HbA 1c ), blood pressure, family behaviour in diabetes care, diabetes knowledge, self-management practices and medication adherence', 'decline in HbA 1c  levels relative', 'blood pressure levels including scores of family behaviour, diabetes knowledge, self-management and medication adherence', 'clinical outcomes, family behaviour, diabetes knowledge, self-management practices and medication adherence']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1321224', 'cui_str': 'Family behavior'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0290805,"Significant differences between groups for changes in blood pressure levels including scores of family behaviour, diabetes knowledge, self-management and medication adherence were found (P ≤ 0.001), with the intervention group showing greater improvement.","[{'ForeName': 'Potjana', 'Initials': 'P', 'LastName': 'Poonprapai', 'Affiliation': 'Pharmacy Division, Sadao Hospital, Songkhla, Thailand.'}, {'ForeName': 'Sanguan', 'Initials': 'S', 'LastName': 'Lerkiatbundit', 'Affiliation': 'Department of Social and Administrative Pharmacy, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Woranuch', 'Initials': 'W', 'LastName': 'Saengcharoen', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand. woranuch.s@psu.ac.th.'}]",International journal of clinical pharmacy,['10.1007/s11096-022-01389-5']
3420,35247102,Continuing versus withholding angiotensin receptor blocker (ARB)/calcium channel blocker (CCB) combination tablets during perioperative periods in patients undergoing minor surgery: a single-blinded randomized controlled trial.,"PURPOSE


This trial was conducted to compare effects of continuing versus withholding single-pill combination tablets consisting of angiotensin receptor blockers (ARBs) and calcium channel blockers (CCBs) on perioperative hemodynamics and clinical outcomes.
METHODS


Patients undergoing minor abdominal or urological surgery (n = 106) were randomly assigned to Group C, in which ARB/CCB combination tablets were continued until surgery, or Group W, in which they were withheld within 24 h of surgery. Perioperative hemodynamics and clinical outcomes were compared between the Groups.
RESULTS


The incidence of hypotension during anesthesia requiring repeated treatment with vasoconstrictors was higher in Group C than Group W (p = 0.0052). Blood pressure during anesthesia was generally lower in Group C than Group W (p < 0.05) despite significantly more doses of ephedrine and phenylephrine administrated in Group C (p = 0.0246 and p = 0.0327, respectively). The incidence of postoperative hypertension did not differ between Groups (p = 0.3793). Estimated glomerular filtration rate (eGFR) on the preoperative day did not differ between Groups (p = 0.7045), while eGFR was slightly lower in Group C than Group W on the first and third postoperative days (p = 0.0400 and p = 0.0088, respectively), although clinically relevant acute kidney injury did not develop.
CONCLUSIONS


Continuing ARB/CCB combination tablets preoperatively in patients undergoing minor surgery increased the incidence of hypotension during anesthesia, increased requirements of vasoconstrictors to treat hypotension, and might deteriorate postoperative renal function, albeit slightly. These results suggest that withholding ARB/CCB tablets preoperatively is preferable to continuing them.
CLINICAL TRIAL REGISTRATION


This trial is registered with the Japan Registry of Clinical Trials (jRCT) at Japanese Ministry of Health, Labour, and Welfare (Trial ID: jRCT1031190027).",2022,"Estimated glomerular filtration rate (eGFR) on the preoperative day did not differ between Groups (p = 0.7045), while eGFR was slightly lower in Group C than Group W on the first and third postoperative days (p = 0.0400 and p = 0.0088, respectively), although clinically relevant acute kidney injury did not develop.
","['Patients undergoing minor abdominal or urological surgery (n\u2009=\u2009106', 'patients undergoing minor surgery']","['phenylephrine', 'ARB/CCB combination tablets', 'angiotensin receptor blocker (ARB)/calcium channel blocker (CCB) combination tablets', 'angiotensin receptor blockers (ARBs) and calcium channel blockers (CCBs', 'ephedrine']","['eGFR', 'perioperative hemodynamics and clinical outcomes', 'Blood pressure during anesthesia', 'Perioperative hemodynamics and clinical outcomes', 'incidence of hypotension during anesthesia, increased requirements of vasoconstrictors to treat hypotension', 'Estimated glomerular filtration rate (eGFR', 'incidence of hypotension', 'incidence of postoperative hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038904', 'cui_str': 'Minor Surgical Procedure'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0520917', 'cui_str': 'Increased metabolic requirement'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0919726', 'cui_str': 'Postoperative hypertension'}]",106.0,0.273998,"Estimated glomerular filtration rate (eGFR) on the preoperative day did not differ between Groups (p = 0.7045), while eGFR was slightly lower in Group C than Group W on the first and third postoperative days (p = 0.0400 and p = 0.0088, respectively), although clinically relevant acute kidney injury did not develop.
","[{'ForeName': 'Kazuyo', 'Initials': 'K', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Hayashida', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan. mhaya@juntendo.ac.jp.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Kudoh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Niimi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Kumi', 'Initials': 'K', 'LastName': 'Kataoka', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Maho', 'Initials': 'M', 'LastName': 'Kakemizu-Watanabe', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Hara', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Kawagoe', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.'}]",Journal of anesthesia,['10.1007/s00540-022-03053-8']
3421,35246416,"Effect of health extension workers led home-based intervention on hypertension management in Northwest Ethiopia, 2021: study protocol for a cluster randomised controlled trial.","INTRODUCTION


Although hypertension is highly prevalent in Ethiopia, it is poorly diagnosed, treated and controlled. Poor access to care and a shortage of healthcare providers are major barriers. This study aims to evaluate the effects of health extension workers' led home-based intervention on hypertension management in patients with hypertension in rural districts of northwest Ethiopia.
METHODS AND ANALYSIS


A two-arm cluster randomised controlled trial will be conducted among 456 hypertensive patients. Adults aged ≥25 years who have a diagnosis of hypertension both in the home-based hypertension screening study and at another measurement prior to recruitment will be eligible for the study. Randomisation will be done at the kebele level. In the intervention clusters, trained health extension workers will provide home-based intervention for hypertensive patients every 2 months for 9 months. The primary outcomes of the trial will be clinical linkage and blood pressure changes, whereas the secondary outcomes will be lifestyle modification, medication adherence and blood pressure control. Intention-to-treat analysis will be used for all primary analyses. A linear mixed-effect regression model will be used to model the change in blood pressure, while a mixed effect logistic regression model will be used to evaluate the intervention's effect on the binary outcomes. Effect sizes such as mean difference for the continuous outcomes and relative risk, attributable risk and population attributable risk for binary outcomes will be used. All statistical analyses are two sided and a p<0.05 will be used.
ETHICS AND DISSEMINATION


This study has been approved by institutional review board of the University of Gondar (Ref. No: V/P/RCS/05/2293/2020). The district's health office will grant permission for cluster randomisation, and each participant will provide written informed consent for participation. The findings will be presented at scientific conferences and published in peer-reviewed scientific journals.
TRIAL REGISTRATION NUMBER


PACTR202102729454417.",2022,"This study aims to evaluate the effects of health extension workers' led home-based intervention on hypertension management in patients with hypertension in rural districts of northwest Ethiopia.
","['Adults aged ≥25 years who have a diagnosis of hypertension both in the home-based hypertension screening study and at another measurement prior to recruitment will be eligible for the study', '456 hypertensive patients', 'patients with hypertension in rural districts of northwest Ethiopia']","['health extension workers led home-based intervention', ""health extension workers' led home-based intervention""]","['clinical linkage and blood pressure changes', 'lifestyle modification, medication adherence and blood pressure control', 'hypertension management']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0740221', 'cui_str': 'Hypertension screening'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",456.0,0.0610556,"This study aims to evaluate the effects of health extension workers' led home-based intervention on hypertension management in patients with hypertension in rural districts of northwest Ethiopia.
","[{'ForeName': 'Destaw Fetene', 'Initials': 'DF', 'LastName': 'Teshome', 'Affiliation': 'Epidemiology and Biostatistics, University of Gondar College of Medicine and Health Sciences, Gondar, Ethiopia destaw.fetene@gmail.com.'}, {'ForeName': 'Shitaye', 'Initials': 'S', 'LastName': 'Alemu', 'Affiliation': 'Internal Medicine, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Tadesse Awoke', 'Initials': 'TA', 'LastName': 'Ayele', 'Affiliation': 'Epidemiology and Biostatistics, University of Gondar College of Medicine and Health Sciences, Gondar, Ethiopia.'}, {'ForeName': 'Asmamaw', 'Initials': 'A', 'LastName': 'Atnafu', 'Affiliation': 'Health System and policy, University of Gondar College of Medicine and Health Sciences, Gondar, Ethiopia.'}, {'ForeName': 'Kassahun Alemu', 'Initials': 'KA', 'LastName': 'Gelaye', 'Affiliation': 'Epidemiology and Biostatistics, University of Gondar College of Medicine and Health Sciences, Gondar, Ethiopia.'}]",BMJ open,['10.1136/bmjopen-2021-051178']
3422,35246413,Surgical fixation with K-wires versus casting in adults with fracture of distal radius: DRAFFT2 multicentre randomised clinical trial.,,2022,,['adults with fracture of distal radius'],['Surgical fixation with K-wires versus casting'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}]",[],,0.217228,,[],BMJ (Clinical research ed.),['10.1136/bmj.o580']
3423,35246404,Cancer and aging: Reflections for elders- Expressive writing intervention: A pilot study.,"OBJECTIVES


The Cancer and Aging: Reflections for Elders Expressive Writing Intervention (CARE-Express) was developed to enhance coping and minimize psychological distress in older adults with cancer. The aim of the current study is to evaluate the feasibility and initial efficacy of CARE-Express.
MATERIALS AND METHODS


Seventy-one distressed older adults (≥70) with cancer were assigned to CARE-Express (n = 41) or the Enhanced Social Work Control (ESWC) arm (n = 30). Participants completed five telephone sessions over seven weeks and were assessed on psychosocial variables at baseline, post-intervention, and four months post study enrollment. Feasibility was assessed by examining rates of eligibility, acceptance, retention, assessment, and fidelity. Initial efficacy was evaluated using standardized effect sizes.
RESULTS


Adequate rates of acceptance (29%), eligibility (66%), retention (90%), assessment (70% at post-intervention, 63% at four month follow-up), and fidelity (97%) were observed. At post-intervention, participants receiving CARE-Express reported less depression compared to ESWC (d = 0.69, p = 0.01) and lower demoralization (d = 0.50, p = 0.06). A small/moderate effect was demonstrated for increased total spirituality scores (d = 0.41, p = 0.07), meaning/peace (d = 0.32, p = 0.20) and faith (d = 0.35, p = 0.07). The CARE-Express group reported greater reductions in behavioral disengagement (d = 0.44, p = 0.06), while ESWC demonstrated a small effect for active coping (d = 0.21, p = 0.31). At four months, differential effects of CARE-Express had attenuated, though small/moderate, effects in favor of CARE-Express remained.
CONCLUSION


Results support the feasibility of CARE-Express and its potential positive impact on psychological well-being.
TRIAL REGISTRATION


Registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT00984321 on September 25, 2009.",2022,"The CARE-Express group reported greater reductions in behavioral disengagement (d = 0.44, p = 0.06), while ESWC demonstrated a small effect for active coping (d = 0.21, p = 0.31).","['older adults with cancer', 'Seventy-one distressed older adults (≥70) with cancer were assigned to CARE-Express (n = 41) or the']","['elders- Expressive writing intervention', 'Enhanced Social Work Control (ESWC', 'Elders Expressive Writing Intervention (CARE-Express']","['behavioral disengagement', 'total spirituality scores', 'Initial efficacy', 'lower demoralization', 'rates of eligibility, acceptance, retention, assessment, and fidelity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}]","[{'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0233498', 'cui_str': 'Demoralization'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0746623,"The CARE-Express group reported greater reductions in behavioral disengagement (d = 0.44, p = 0.06), while ESWC demonstrated a small effect for active coping (d = 0.21, p = 0.31).","[{'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Tutino', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Avenue, New York, NY, United States; Fordham University, 441 East Fordham Road, Dealy 226, Bronx, NY, United States. Electronic address: tutinorebecca@gmail.com.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Saracino', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Avenue, New York, NY, United States.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kelman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Avenue, New York, NY, United States.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Schofield', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Avenue, New York, NY, United States.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Roth', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Avenue, New York, NY, United States.'}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Nelson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Avenue, New York, NY, United States.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2022.02.009']
3424,35246403,Diagnostic concordance and discordance between angiography-based quantitative flow ratio and fractional flow reserve derived from computed tomography in complex coronary artery disease.,"BACKGROUND


Both quantitative flow ratio (QFR) and fractional flow reserve derived from computed tomography (FFR CT ) have shown significant correlations with invasive wire-based fractional flow reserve. However, the correlation between QFR and FFR CT  is not fully investigated in patients with complex coronary artery disease (CAD). The aim of this study is to investigate the correlation and agreement between QFR and FFR CT  in patients with de novo three-vessel disease and/or left main CAD.
METHODS


This is a post-hoc sub-analysis of the international, multicenter, and randomized SYNTAX III REVOLUTION trial, in which both invasive coronary angiography and coronary computed tomography angiography were prospectively obtained prior to the heart team discussion. QFR was performed in an independent core laboratory and compared with FFR CT  analyzed by HeartFlow™. The correlation and agreement between QFR and FFR CT  were assessed per vessel. Furthermore, independent factors of diagnostic discordance between QFR and FFR CT  were evaluated.
RESULTS


Out of 223 patients, 40 patients were excluded from this analysis due to the unavailability of FFR CT  and/or QFR, and a total of 469 vessels (183 patients) were analyzed. There was a strong correlation between QFR and FFR CT  (R ​= ​0.759; p ​< ​0.001), and the Bland-Altman analysis demonstrated a mean difference of -0.005 and a standard deviation of 0.116. An independent predictor of diagnostic concordance between QFR and FFR CT  was the lesion location in right coronary artery (RCA) (odds ratio 0.395; 95% confidence interval 0.174-0.894; P ​= ​0.026).
CONCLUSION


In patients with complex CAD, QFR and FFR CT  were strongly correlated. The location of the lesion in RCA was associated with the highest diagnostic concordance between QFR and FFR CT .",2022,The location of the lesion in RCA was associated with the highest diagnostic concordance between QFR and FFR CT .,"['patients with de novo three-vessel disease and/or left main CAD', 'complex coronary artery disease', 'patients with complex coronary artery disease (CAD', '223 patients, 40 patients were excluded from this analysis due to the unavailability of FFR CT  and/or QFR, and a total of 469 vessels (183 patients) were analyzed']","['QFR and FFR CT', 'invasive coronary angiography and coronary computed tomography angiography', 'computed tomography (FFR CT ', 'angiography-based quantitative flow ratio and fractional flow reserve derived from computed tomography']","['QFR and FFR CT', 'QFR', 'quantitative flow ratio (QFR) and fractional flow reserve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0686905', 'cui_str': 'Unavailability'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517615', 'cui_str': '183'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}]",469.0,0.092288,The location of the lesion in RCA was associated with the highest diagnostic concordance between QFR and FFR CT .,"[{'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Discipline of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and CORRIB Core Lab, National University of Ireland Galway (NUIG), Galway, Ireland; Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands; Division of Cardiology, Department of Internal Medicine, Teikyo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Discipline of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and CORRIB Core Lab, National University of Ireland Galway (NUIG), Galway, Ireland; Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Discipline of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and CORRIB Core Lab, National University of Ireland Galway (NUIG), Galway, Ireland; Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Johan H C', 'Initials': 'JHC', 'LastName': 'Reiber', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Thomsen', 'Affiliation': 'GE Healthcare, Milwaukee, WI, USA.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Universitair Ziekenhuis Brussel, VUB, Brussels, Belgium.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'La Meir', 'Affiliation': 'Universitair Ziekenhuis Brussel, VUB, Brussels, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'de Mey', 'Affiliation': 'Universitair Ziekenhuis Brussel, VUB, Brussels, Belgium.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schneider', 'Affiliation': 'Jena University Hospital, Friedrich-Schiller-University of Jena, Jena, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Doenst', 'Affiliation': 'Jena University Hospital, Friedrich-Schiller-University of Jena, Jena, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Teichgräber', 'Affiliation': 'Jena University Hospital, Friedrich-Schiller-University of Jena, Jena, Germany.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'Discipline of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and CORRIB Core Lab, National University of Ireland Galway (NUIG), Galway, Ireland; CÚRAM, The SFI Research Centre for Medical Devices, Galway, Ireland.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Mushtaq', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Pompilio', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy; Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy.'}, {'ForeName': 'Antonio L', 'Initials': 'AL', 'LastName': 'Bartorelli', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy; Department of Biomedical and Clinical Sciences ""Luigi Sacco"", University of Milan, Milan, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Andreini', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy; Department of Clinical Sciences and Community Health, Cardiovascular Section, University of Milan, Milan, Italy.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Discipline of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and CORRIB Core Lab, National University of Ireland Galway (NUIG), Galway, Ireland; CÚRAM, The SFI Research Centre for Medical Devices, Galway, Ireland; NHLI, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Discipline of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and CORRIB Core Lab, National University of Ireland Galway (NUIG), Galway, Ireland; CÚRAM, The SFI Research Centre for Medical Devices, Galway, Ireland.'}]",Journal of cardiovascular computed tomography,['10.1016/j.jcct.2022.02.004']
3425,35246330,Assessment of the short-term outcomes of laparoscopic gastrectomy after neoadjuvant chemotherapy for locally advanced gastric cancer: A prospective single-armed clinical trial.,"BACKGROUND


Laparoscopic surgical approaches for gastric cancer after neoadjuvant chemotherapy are increasing, yet there is limited evidence of their safety and effectiveness.
METHODS


This prospective single-armed clinical trial enrolled 80 neoadjuvant chemotherapy patients who underwent laparoscopic gastrectomy. In addition, to better analyze the outcomes of this study, 1:2 propensity score matching was performed, and a contemporaneous historic control group containing 160 laparoscopic gastrectomy patients without neoadjuvant chemotherapy was established.
RESULTS


Analyses were performed to compare the neoadjuvant chemotherapy group (n = 80) and the control group (n = 160). The general clinical data of both groups were comparable. The neoadjuvant chemotherapy group showed less intraoperative bleeding (P = .029) and recovered more quickly than the control group (all P < .05). The 2 groups did not exhibit major differences in terms of postoperative complications (P = .679) or severe complications (P = .055). The proportion of patients with ypT4 stage and ypN3 stage disease in the neoadjuvant chemotherapy group totaled 20.7% and 23.8%, respectively, which was significantly lower than that observed in the control group (P < .05). The number of metastatic lymph nodes was 4.8 ± 7.0 in the neoadjuvant chemotherapy group, which was lower than that in the control group (P < .001). In the neoadjuvant chemotherapy group, the major pathological regression rate was 27.5%, while the objective radiologic response rate (complete response + partial response) was 64.0%. In contrast to nonresponding patients, the patients who experienced an objective response had a shorter operation time (P < .001), less intraoperative bleeding (P < .001), and fewer metastatic lymph nodes (P = .005). The short-term effects observed in the nonresponding patients were similar to those observed in the control group.
CONCLUSION


Laparoscopic gastrectomy could achieve improved short-term outcomes through NACT tumor downstaging without increasing the incidence of postoperative complications. Further multicenter and prospective clinical trials are warranted.",2022,The 2 groups did not exhibit major differences in terms of postoperative complications (P = .679) or severe complications (P = .055).,"['locally advanced gastric cancer', '80 neoadjuvant chemotherapy patients who underwent', '160 laparoscopic gastrectomy patients without']","['laparoscopic gastrectomy', 'neoadjuvant chemotherapy', 'laparoscopic gastrectomy after neoadjuvant chemotherapy', 'Laparoscopic gastrectomy']","['objective radiologic response rate', 'shorter operation time', 'severe complications', 'major pathological regression rate', 'intraoperative bleeding', 'postoperative complications', 'metastatic lymph nodes', 'number of metastatic lymph nodes', 'proportion of patients with ypT4 stage and ypN3 stage disease']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",80.0,0.0525409,The 2 groups did not exhibit major differences in terms of postoperative complications (P = .679) or severe complications (P = .055).,"[{'ForeName': 'Ru-Hong', 'Initials': 'RH', 'LastName': 'Tu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Jian-Xian', 'Initials': 'JX', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Xie', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Jia-Bin', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qi-Yue', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Long-Long', 'Initials': 'LL', 'LastName': 'Cao', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ze-Ning', 'Initials': 'ZN', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ju-Li', 'Initials': 'JL', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Hua-Long', 'Initials': 'HL', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Chao-Hui', 'Initials': 'CH', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Chang-Ming', 'Initials': 'CM', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China. Electronic address: hcmlr2002@163.com.'}]",Surgery,['10.1016/j.surg.2022.01.015']
3426,35246272,Feasibility and acceptability of a whole-school social-marketing intervention to prevent unintended teenage pregnancies and promote sexual health: evidence for progression from a pilot to a phase III randomised trial in English secondary schools.,"BACKGROUND


Reducing unintended teenage pregnancy and promoting adolescent sexual health remains a priority in England. Both whole-school and social-marketing interventions are promising approaches to addressing these aims. However, such interventions have not been rigorously trialled in the UK and it is unclear if they are appropriate for delivery in English secondary schools. We developed and pilot trialled Positive Choices, a new whole-school social marketing intervention to address unintended teenage pregnancy and promote sexual health. Our aim was to assess the feasibility and acceptability of the intervention and trial methods in English secondary schools against pre-defined progression criteria (relating to randomisation, survey follow-up, intervention fidelity and acceptability and linkage to birth/abortion records) prior to carrying out a phase III trial of effectiveness and cost-effectiveness.
METHODS


Pilot RCT with integral process evaluation involving four intervention and two control schools in south-east England. The intervention comprised a student needs survey; a student/staff-led school health promotion council; a classroom curriculum for year-9 students (aged 13-14); whole-school student-led social-marketing activities; parent information; and a review of local and school-based sexual health services. Baseline surveys were conducted with year 8 (aged 12-13) in June 2018. Follow-up surveys were completed 12 months later. Process evaluation data included audio recording of staff training, surveys of trained staff, staff log books and researcher observations of intervention activities. Survey data from female students were linked to records of births and abortions to assess the feasibility of these constituting a phase III primary outcome.
RESULTS


All six schools were successfully randomised and retained in the trial. Response rates to the survey were above 80% in both arms at both baseline and follow-up. With the exception of the parent materials, the fidelity target for implementation of essential elements in three out of four schools was achieved. Student surveys indicated 80% acceptability among those who reported awareness of the programme and interviews with staff suggested strong acceptability. Linkage to birth/abortion records was feasible although none occurred among participants.
CONCLUSIONS


The criteria for progression to a phase III trial were met. Our data suggest that a whole-school social-marketing approach may be appropriate for topics that are clearly prioritised by schools. A phase III trial of this intervention is now warranted to establish effectiveness and cost-effectiveness. Births and terminations are not an appropriate primary outcome measure for such a trial.
TRIAL REGISTRATION


ISRCTN65324176.",2022,"We developed and pilot trialled Positive Choices, a new whole-school social marketing intervention to address unintended teenage pregnancy and promote sexual health.","['female students', 'Baseline surveys were conducted with year 8 (aged 12-13) in June 2018', 'Pilot RCT with integral process evaluation involving four intervention and two control schools in south-east England']","['student needs survey; a student/staff-led school health promotion council; a classroom curriculum for year-9 students (aged 13-14); whole-school student-led social-marketing activities; parent information; and a review of local and school-based sexual health services', 'whole-school social-marketing intervention']","['feasibility and acceptability', 'Feasibility and acceptability', 'Response rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3489533', 'cui_str': 'School Health Promotion'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",6.0,0.105215,"We developed and pilot trialled Positive Choices, a new whole-school social marketing intervention to address unintended teenage pregnancy and promote sexual health.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ponsford', 'Affiliation': 'Department of Public Health, Environments & Society, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK. Ruth.Ponsford@lshtm.ac.uk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bragg', 'Affiliation': 'Department of Education, Practice and Society, University College London, 20 Bedford Way, WC1H 0AL, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Meiksin', 'Affiliation': 'Department of Public Health, Environments & Society, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tilouche', 'Affiliation': 'Department of Public Health, Environments & Society, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Van Dyck', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sturgess', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Elbourne', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hadley', 'Affiliation': 'Teenage Pregnancy Knowledge Exchange, University of Bedfordshire, University Square, Luton, LU1 3JU, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lohan', 'Affiliation': 'School of Nursing and Midwifery, Queens University Belfast, University Road, Belfast, BT7 1NN, UK.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Mercer', 'Affiliation': 'University College London, Gower Street, London, WC1E 6BT, UK.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Melendez Torres', 'Affiliation': ""University of Exeter, St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': ""Department of Health and Primary Care, University of Exeter, St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Young', 'Affiliation': 'School of Social Sciences, Cardiff University, 1-3 Museum Place, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Campbell', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Department of Public Health, Environments & Society, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-022-00971-y']
3427,35246243,The glucose-lowering effect of low-dose diacerein and its responsiveness metabolic markers in uncontrolled diabetes.,"OBJECTIVE


Diacerein inhibits the synthesis and activity of pro-inflammatory cytokines, decreases macrophage infiltration in adipose tissue and thus increases insulin sensitivity and signalling. We conducted this study to determine the efficacy of low-dose diacerein in improving glycaemic control in type 2 diabetes mellitus (T2DM) patients with inadequate glycaemic control and to identify the metabolic determinants for such improvement. We randomised 25 T2DM patients with poor glycaemic control, despite being treated with at least three glucose-lowering agents, to receive diacerein 50 mg once-daily (n = 18) or placebo (n = 17) for 12 weeks. Changes in glycated haemoglobin (HbA1c) were evaluated at the 4th and 12th weeks. Metabolic profiling was performed using liquid chromatography electrospray ionisation quadrupole time-of-flight mass spectrometry.
RESULTS


HbA1c levels were significantly reduced from baseline in the diacerein group at 12 weeks (- 0.6%, p < 0.05), whereas fasting plasma glucose (FPG) levels were not significantly decreased (- 18.9 mg/dl, p = 0.06). Partial least squares-discriminant analysis demonstrated an association between the serum abundance of threo-isocitric acid (ICA) and HbA1c response in the diacerein group. After adjusting for serum high-sensitivity C-reactive protein, ICA was still significantly related to the change in HbA1c. Retrospective trial registration Current Controlled Trials TCTR20200820004, 20 August 2020.",2022,"RESULTS


HbA1c levels were significantly reduced from baseline in the diacerein group at 12 weeks (- 0.6%, p < 0.05), whereas fasting plasma glucose (FPG) levels were not significantly decreased (- 18.9 mg/dl, p = 0.06).","['20 August 2020', 'uncontrolled diabetes', 'type 2 diabetes mellitus (T2DM) patients with inadequate glycaemic control', '25 T2DM patients with poor glycaemic control, despite being treated with at least three glucose-lowering agents, to receive']","['diacerein 50\xa0mg once-daily (n\u2009=\u200918) or placebo', 'low-dose diacerein']","['serum abundance of threo-isocitric acid (ICA) and HbA1c response', 'HbA1c levels', 'fasting plasma glucose (FPG) levels', 'glycated haemoglobin (HbA1c', 'glycaemic control']","[{'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0057678', 'cui_str': 'diacetylrhein'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1304810', 'cui_str': 'isocitric acid'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",25.0,0.0432053,"RESULTS


HbA1c levels were significantly reduced from baseline in the diacerein group at 12 weeks (- 0.6%, p < 0.05), whereas fasting plasma glucose (FPG) levels were not significantly decreased (- 18.9 mg/dl, p = 0.06).","[{'ForeName': 'Jintanan', 'Initials': 'J', 'LastName': 'Jangsiripornpakorn', 'Affiliation': 'Taksin Hospital, Bangkok, Thailand.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Srisuk', 'Affiliation': 'Bangkok Metropolitan Administration General Hospital, Bangkok, Thailand.'}, {'ForeName': 'Laor', 'Initials': 'L', 'LastName': 'Chailurkit', 'Affiliation': 'Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Hataikarn', 'Initials': 'H', 'LastName': 'Nimitphong', 'Affiliation': 'Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sunee', 'Initials': 'S', 'LastName': 'Saetung', 'Affiliation': 'Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Boonsong', 'Initials': 'B', 'LastName': 'Ongphiphadhanakul', 'Affiliation': 'Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. boonsong.ong@mahidol.ac.th.'}]",BMC research notes,['10.1186/s13104-022-05974-9']
3428,35246228,"Trauma-focused EMDR for Personality disorders among Outpatients (TEMPO): study protocol for a multi-centre, single-blind, randomized controlled trial.","BACKGROUND


Existing recommended treatment options for personality disorders (PDs) are extensive and costly. There is emerging evidence indicating that trauma-focused treatment using eye movement desensitization and reprocessing (EMDR) therapy aimed at resolving memories of individuals' adverse events can be beneficial for this target group within a relatively short time frame. The primary purpose of the present study is to determine the effectiveness of EMDR therapy versus waiting list in reducing PD symptom severity. Furthermore, the effects of EMDR therapy on trauma symptom severity, loss of diagnosis, personal functioning, quality of life, and mental health outcomes will be determined. In addition, the cost-effectiveness of EMDR therapy in the treatment of PDs is investigated. Moreover, predictors of treatment success, symptom deterioration and treatment discontinuation will be assessed. Lastly, experiences with EMDR therapy will be explored.
METHOD


In total, 159 patients with a PD will be included in a large multicentre single-blind randomized controlled trial. The Structured Clinical Interview for DSM-5 Personality Disorders will be used to determine the presence of a PD. Participants will be allocated to either a treatment condition with EMDR therapy (ten biweekly 90-min sessions) or a waiting list. Three months after potential treatment with EMDR therapy, patients can receive treatment as usual for their PD. All participants are subject to single-blinded baseline, post-intervention and 3-, 6- and 12-month follow-up assessments. The primary outcome measures are the Assessment of DSM-IV Personality Disorders and the Clinician-Administered PTSD Scale for DSM-5. For cost-effectiveness, the Treatment Inventory of Costs in Patients with psychiatric disorders, EuroQol-5D-3L, and the Mental Health Quality of Life Questionnaire will be administered. The PTSD Checklist for DSM-5, Brief State Paranoia Checklist and Difficulties in Emotion Regulation Scale will be used to further index trauma symptom severity. Type of trauma is identified at baseline with the Childhood Trauma Questionnaire-SF and Life Events Checklist for the DSM-5. Personal functioning and health outcome are assessed with the Level of Personality Functioning Scale-BF 2.0, Outcome Questionnaire-45 and Mental Health Quality of Life Questionnaire. Experiences with EMDR therapy of patients in the EMDR therapy condition are explored with a semi-structured interview at post-intervention.
DISCUSSION


It is expected that the results of this study will contribute to knowledge about the effectiveness, and cost-effectiveness of trauma-focused treatment using EMDR therapy in individuals diagnosed with a PD. Follow-up data provide documentation of long-term effects of EMDR therapy on various outcome variables, most importantly the reduction of PD symptom severity and loss of diagnoses.
TRIAL REGISTRATION


Netherlands Trial Register NL9078 . Registered on 31 November 2020.",2022,"Furthermore, the effects of EMDR therapy on trauma symptom severity, loss of diagnosis, personal functioning, quality of life, and mental health outcomes will be determined.","['Patients with psychiatric disorders', 'individuals diagnosed with a PD', 'Outpatients (TEMPO', '159 patients with a PD']","['EMDR therapy', 'EMDR therapy versus waiting list', 'Trauma-focused EMDR']","['Assessment of DSM-IV Personality Disorders and the Clinician-Administered PTSD Scale for DSM-5', 'trauma symptom severity, loss of diagnosis, personal functioning, quality of life, and mental health outcomes', 'Level of Personality Functioning Scale-BF 2.0, Outcome Questionnaire-45 and Mental Health Quality of Life Questionnaire', 'PD symptom severity', 'PD symptom severity and loss of diagnoses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3164706', 'cui_str': 'Eye movement desensitization and reprocessing therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0031212', 'cui_str': 'Personality disorder'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",159.0,0.0751442,"Furthermore, the effects of EMDR therapy on trauma symptom severity, loss of diagnosis, personal functioning, quality of life, and mental health outcomes will be determined.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hofman', 'Affiliation': 'Department of Personality Disorders, Parnassia Psychiatric Institute, Lijnbaan 4, 2512VA, The Hague, The Netherlands.'}, {'ForeName': 'Laurian', 'Initials': 'L', 'LastName': 'Hafkemeijer', 'Affiliation': 'Department of Adult Psychiatry, GGZ Delfland, Delft, The Netherlands.'}, {'ForeName': 'Ad', 'Initials': 'A', 'LastName': 'de Jongh', 'Affiliation': 'Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and VU University Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'Starrenburg', 'Affiliation': 'Department of Adult Psychiatry, GGZ Delfland, Delft, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Slotema', 'Affiliation': 'Department of Personality Disorders, Parnassia Psychiatric Institute, Lijnbaan 4, 2512VA, The Hague, The Netherlands. c.slotema@psyq.nl.'}]",Trials,['10.1186/s13063-022-06082-6']
3429,35246949,Physiological role of anticipatory cardiorespiratory responses to exercise.,"This study aimed to investigate whether anticipatory cardiorespiratory responses vary depending on the intensity of the subsequent exercise bout, and whether anticipatory cardiorespiratory adjustments contribute importantly to enhancing exercise performance during high-intensity exercise. Eleven healthy men were provided advance notice of the exercise intensity and a countdown to generate anticipation during 10 min prior to exercise at 0, 50, 80 or 95% maximal work-rate (Experiment 1). A different group of subjects (n = 15) performed a time to exhaustion trial with or without anticipatory countdown (Experiment 2). In Experiment 1, heart rate (HR), oxygen uptake (V O2  ) and minute ventilation (V E  ) during pre-exercise resting period increased over time and depended on the subsequent exercise intensity. Specifically, there was already a 7.4% increase in HR from more than 5 min prior to the start of exercise at 95% maximal work-rate, followed by progressively augmented increases of 12.5% between 2 and 3 min before exercise, 24.4% between 0 and 1 min before exercise. In Experiment 2, the initial HR for the first 10 s of exercise in the task with anticipation was 11.4% larger compared to without anticipation (p < 0.01), and the difference in HR between the two conditions decreased in a time-dependent manner. In contrast, the initial increases in V O2  and V E  were significantly lower in the task with anticipation than that without anticipation. The time to exhaustion during high-intensity exercise was 14.6% longer under anticipation condition compared to no anticipation (135 ± 26 s vs. 119 ± 26 s, p = 0.003). In addition, the enhanced exercise performance correlated positively with increased HR response just before and immediately after exercise onset (p < 0.01). These results showed that anticipatory cardiorespiratory adjustments (feedforward control) via the higher brain that operate before starting exercise may play an important role in minimizing the time delay of circulatory response and enhancing performance after onset of high-intensity exercise in man.",2022,The time to exhaustion during high-intensity exercise was 14.6% longer under anticipation condition compared to no anticipation (135 ± 26 s vs. 119 ± ,['Eleven healthy men'],['time to exhaustion trial with or without anticipatory countdown'],"['time to exhaustion during high-intensity exercise', 'enhanced exercise performance', 'HR', 'HR response', 'exercise performance', 'initial increases in V O2  and V E', 'heart rate (HR), oxygen uptake (V O2  ) and minute ventilation (V E  ']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231963', 'cui_str': 'Volume of expired gas'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}]",11.0,0.00901084,The time to exhaustion during high-intensity exercise was 14.6% longer under anticipation condition compared to no anticipation (135 ± 26 s vs. 119 ± ,"[{'ForeName': 'Tadayoshi', 'Initials': 'T', 'LastName': 'Miyamoto', 'Affiliation': 'Division of Human Environment, Graduate School of Human Environment, Osaka Sangyo University, Daito City, Osaka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sotobayashi', 'Affiliation': 'Department of Education, Faculty of Education, Osaka Seikei University, Osaka City, Osaka, Japan.'}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Ito', 'Affiliation': 'Division of Human Environment, Graduate School of Human Environment, Osaka Sangyo University, Daito City, Osaka, Japan.'}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Kawai', 'Affiliation': 'Laboratory for Pathophysiological and Health Science, RIKEN Center for Biosystems Dynamics Research, Kobe City, Hyogo, Japan.'}, {'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Nakahara', 'Affiliation': 'Graduate School of Health Sciences, Morinomiya University of Medical Sciences, Osaka City, Osaka, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Physical Education, Faculty of Education, Gifu University, Gifu City, Gifu, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Toyama', 'Affiliation': 'Faculty of Medical Sciences, Kyushu University, Fukuoka City, Fukuoka, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Saku', 'Affiliation': 'Department of Cardiovascular Dynamics, National Cerebral and Cardiovascular Center Research Institute, Suita City, Osaka, Japan.'}, {'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Nakanishi', 'Affiliation': 'Department of Sport and Health Sciences, Faculty of Sport and Health Sciences, Osaka Sangyo University, Daito City, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kinoshita', 'Affiliation': 'Center for Common Education, Osaka Aoyama University, Minoh City, Osaka, Japan.'}]",Physiological reports,['10.14814/phy2.15210']
3430,35246827,"Exploratory Analysis Comparing Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting (CINV): A Randomized, Double-Blind, Phase 3 Study (CONSOLE).","INTRODUCTION


We describe the results of an exploratory analysis performed on the first head-to-head study (JapicCTI-194611) comparing two different intravenous (IV) neurokinin 1 (NK 1 ) receptor antagonists, fosnetupitant and fosaprepitant, in combination with palonosetron (PALO) and dexamethasone (DEX) for the prevention of highly emetogenic chemotherapy (HEC)-induced nausea and vomiting (CINV). This analysis was performed to validate the findings of the primary analysis (previously published) utilizing a last observation carried forward (LOCF) approach for missing values for the efficacy endpoint of complete response (no emetic event and no rescue medication), while also evaluating the time periods encompassing the 0-168-hour (h) ""extended overall phase"" interval.
METHODS


Patients scheduled to receive cisplatin-based chemotherapy were randomized 1:1 to fosnetupitant 235 mg or fosaprepitant 150 mg in combination with PALO 0.75 mg and DEX. Complete response rates were calculated and compared (stratified by age category and sex with a Mantel-Haenszel test) during the study's primary overall phase (0-120 h) and during additional time intervals of interest [acute (0-24 h), delayed (24-120 h), extended delayed (> 24-168 h), beyond delayed (120-168 h), and extended overall (0-168 h)].
RESULTS


A total of 785 patients were included (fosnetupitant N = 392, fosaprepitant N = 393). Complete response rates were numerically higher for fosnetupitant versus fosaprepitant for all time intervals and statistically significant for the extended overall phase. Complete response rates for fosnetupitant versus fosaprepitant during the overall, acute, delayed, extended delayed, beyond delayed, and extended overall phases were 75.5% vs. 71.0% (p = 0.1530), 93.9% vs. 92.6% (p = 0.4832), 77.0% vs. 72.8% (p = 0.1682), 74.7% vs. 68.4% (p = 0.0506), 86.7% vs. 81.7% (p = 0.0523), and 73.5% vs. 66.9% (p = 0.0450), respectively.
CONCLUSION


In this exploratory analysis, fosnetupitant appeared to be more effective than fosaprepitant in preventing CINV associated with cisplatin-based HEC during the extended 7-day period following chemotherapy.",2022,Complete response rates were numerically higher for fosnetupitant versus fosaprepitant for all time intervals and statistically significant for the extended overall phase. ,"['Patients scheduled to receive', '785 patients were included (fosnetupitant N\u2009=\u2009392, fosaprepitant N\u2009=\u2009393']","['cisplatin-based HEC', 'intravenous (IV) neurokinin 1 (NK 1 ) receptor antagonists, fosnetupitant and fosaprepitant, in combination with palonosetron (PALO) and dexamethasone (DEX', 'fosnetupitant 235\xa0mg or fosaprepitant 150\xa0mg in combination with PALO 0.75\xa0mg and DEX', 'cisplatin-based chemotherapy']","['Nausea and Vomiting (CINV', 'Complete response rates']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4691680', 'cui_str': 'Fosnetupitant'}, {'cui': 'C2349941', 'cui_str': 'fosaprepitant'}, {'cui': 'C4517754', 'cui_str': '393'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C4691680', 'cui_str': 'Fosnetupitant'}, {'cui': 'C2349941', 'cui_str': 'fosaprepitant'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4691685', 'cui_str': 'fosnetupitant 235 MG'}, {'cui': 'C4074639', 'cui_str': 'fosaprepitant 150 MG'}, {'cui': 'C4068882', 'cui_str': '0.75'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",785.0,0.155236,Complete response rates were numerically higher for fosnetupitant versus fosaprepitant for all time intervals and statistically significant for the extended overall phase. ,"[{'ForeName': 'Akito', 'Initials': 'A', 'LastName': 'Hata', 'Affiliation': 'Department of Thoracic Oncology, Kobe Minimally Invasive Cancer Center, 8-5-1 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan. akitohata@hotmail.com.'}, {'ForeName': 'Yoshimasa', 'Initials': 'Y', 'LastName': 'Shiraishi', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Inui', 'Affiliation': 'Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Morihito', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Department of Surgical Oncology, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Morise', 'Affiliation': 'Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Akiyoshi', 'Affiliation': 'Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Takeda', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Department of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Shinagawa', 'Affiliation': 'Department of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Saeki', 'Affiliation': 'Department of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Tomohide', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': ""Thoracic Center, St. Luke's International Hospital, Tokyo, Japan.""}]",Oncology and therapy,['10.1007/s40487-022-00188-2']
3431,35246775,The Vermont Family Based Approach in Primary Care Pediatrics: Effects on Children's and Parents' Emotional and Behavioral Problems and Parents' Health-Related Quality of Life.,"This randomized controlled trial tested the Vermont Family Based Approach (VFBA) in primary care pediatrics. The VFBA is a model of healthcare delivery that shifts the focus from the individual to the family, emphasizes emotional and behavioral health, and uses evidence-based health promotion/prevention along with the treatment of emotional and behavioral problems. Participants were 81 families of 3-15-year-olds. For children, the VFBA was associated with greater reductions than the Control condition on the Child Behavior Checklist Emotionally Reactive, Withdrawn, Sleep Problems, Aggressive Behavior and Total Problems scales. For parents, the VFBA was associated with greater reductions than the Control condition on the Adult Self-Report Anxious/Depressed, Rule-Breaking Behavior, Internalizing Problems and Total Problems scales. The VFBA was also associated with greater improvement than the Control condition in the parents' health-related quality of life, as indicated by all scales of the Medical Outcomes Study Health Survey.",2022,"The VFBA was also associated with greater improvement than the Control condition in the parents' health-related quality of life, as indicated by all scales of the Medical Outcomes Study Health Survey.","['Participants were 81 families of 3-15-year-olds', 'primary care pediatrics']",['Vermont Family Based Approach (VFBA'],"['Adult Self-Report Anxious/Depressed, Rule-Breaking Behavior, Internalizing Problems and Total Problems scales', 'Child Behavior Checklist Emotionally Reactive, Withdrawn, Sleep Problems, Aggressive Behavior and Total Problems scales']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0042537', 'cui_str': 'Vermont'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]",81.0,0.0274786,"The VFBA was also associated with greater improvement than the Control condition in the parents' health-related quality of life, as indicated by all scales of the Medical Outcomes Study Health Survey.","[{'ForeName': 'Masha Y', 'Initials': 'MY', 'LastName': 'Ivanova', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, VT, USA. masha.ivanova@med.uvm.edu.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Weinberger', 'Affiliation': 'Department of Pediatrics, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Buckingham', 'Affiliation': 'Department of Psychology, University of Alaska Anchorage, Anchorage, AK, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Copeland', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Phoenix', 'Initials': 'P', 'LastName': 'Crockett', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Dainer-Best', 'Affiliation': 'Psychology Program, Bard College, Annandale-on-Hudson, NY, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': ""D'Alberto"", 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Dewey', 'Affiliation': 'Department of Psychological Sciences, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'DeShan', 'Initials': 'D', 'LastName': 'Foret', 'Affiliation': 'University of Alaska Fairbanks, Fairbanks, AK, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Galano', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts at Amherst, Amherst, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Goodrich', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Holly', 'Affiliation': 'Department of Psychology, Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'Nalini', 'Initials': 'N', 'LastName': 'Lane', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Leahey', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Lerner', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Marsh', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'McGinnis', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Paiva-Salisbury', 'Affiliation': 'Department of Psychology, Coastal Carolina University, Conway, SC, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Shaw', 'Affiliation': 'Department of Pediatrics, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Swift', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Tinker', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Hudziak', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, VT, USA.'}]",Child psychiatry and human development,['10.1007/s10578-022-01329-4']
3432,35246766,Effects of photobiomodulation and deep water running in patients with chronic non-specific low back pain: a randomized controlled trial.,"Photobiomodulation therapy (PBM) is often used to treat musculoskeletal disorders such as chronic non-specific low back pain (NSCLBP) as it can have positive effects on biomarkers-creatine kinase (CK) and serum cortisol levels-related to stress caused by physical exercise, such as deep water running (DWR) or by pain. The aim of this study was to evaluate the effects of the combination of PBM and aquatic exercise (DWR) on the intensity of pain, disability, 6-min walk test adapted (6WTA), and on cortisol and creatine kinase (CK) levels in a population with NSCLBP. The participants were allocated into three groups: TG PBM  (Photobiomodulation and Training Group), TG PLA  (Placebo Photobiomodulation and Training Group), and the G PBM  (Photobiomodulation Group). Information regarding anthropometric data, blood pressure, and heart rate were collected, and the questionnaires were applied: IPAQ-Short Form, Oswestry Disability Index, and the Visual Analog Scale for Pain. The submaximal exercise test (6WTA) was performed. Blood was collected for analysis of cortisol and CK levels. The training sessions were performed twice a week, for 4 weeks. In the intragroup comparisons, there were statistically significant changes in the TG PBM  and G PBM  groups in the outcomes pain intensity, disability (reductions in both groups), and in cortisol (increased in the TG PBM  and reduced in the G PBM ); in the TG PLA  group, there was a statistically significant reduction only in the outcome of pain intensity. In the intergroup comparison, in the comparison between TG PBM  and TG PLA , there was a statistically significant difference in the level of cortisol, as well as in the comparison between TG PBM  and G PBM , in which there was a statistically significant difference for this same outcome (cortisol) and for the 6WTA outcome. The effects of the combination of PBM and aquatic exercise have positive effects on reducing pain intensity, disability, and cortisol levels, but its effects on other variables (6WTA and CK) are too small to be considered significant. Trial registration number: NCT03465228-April 3, 2019; retrospectively registered (ClinicalTrials.gov).",2022,"The effects of the combination of PBM and aquatic exercise have positive effects on reducing pain intensity, disability, and cortisol levels, but its effects on other variables (6WTA and CK) are too small to be considered significant.","['patients with chronic non-specific low back pain', 'a population with NSCLBP']","['submaximal exercise test (6WTA', 'TG PBM  (Photobiomodulation and Training Group), TG PLA  (Placebo Photobiomodulation and Training Group), and the G PBM  (Photobiomodulation Group', 'PBM and aquatic exercise', 'Photobiomodulation therapy (PBM', 'PBM and aquatic exercise (DWR', 'photobiomodulation and deep water running']","['pain intensity, disability', 'intensity of pain, disability, 6-min walk test adapted (6WTA), and on cortisol and creatine kinase (CK) levels', 'IPAQ-Short Form, Oswestry Disability Index, and the Visual Analog Scale for Pain', 'anthropometric data, blood pressure, and heart rate', 'level of cortisol', 'pain intensity, disability, and cortisol levels', 'pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0450462', 'cui_str': 'Running water'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",,0.0421272,"The effects of the combination of PBM and aquatic exercise have positive effects on reducing pain intensity, disability, and cortisol levels, but its effects on other variables (6WTA and CK) are too small to be considered significant.","[{'ForeName': 'Daniele Mayumi Kurata', 'Initials': 'DMK', 'LastName': 'Nardin', 'Affiliation': 'Program Stricto Sensu in Rehabilitation Sciences, Research and Postgraduate Center, UNOPAR/UEL, Londrina, Brazil.'}, {'ForeName': 'Marieli Ramos', 'Initials': 'MR', 'LastName': 'Stocco', 'Affiliation': 'Program Stricto Sensu in Rehabilitation Sciences, Research and Postgraduate Center, UNOPAR/UEL, Londrina, Brazil. marieliramosstocco@hotmail.com.'}, {'ForeName': 'Andreo Fernando', 'Initials': 'AF', 'LastName': 'Aguiar', 'Affiliation': 'Program Stricto Sensu in Rehabilitation Sciences, Research and Postgraduate Center, UNOPAR/UEL, Londrina, Brazil.'}, {'ForeName': 'Fabiana Andrade', 'Initials': 'FA', 'LastName': 'Machado', 'Affiliation': 'Program Stricto Sensu in Physical Education, Research and Postgraduate Center, UEM/UEL, Maringá, Brazil.'}, {'ForeName': 'Raphael Gonçalves', 'Initials': 'RG', 'LastName': 'de Oliveira', 'Affiliation': 'Program Stricto Sensu in Rehabilitation Sciences, Research and Postgraduate Center, UNOPAR/UEL, Londrina, Brazil.'}, {'ForeName': 'Rodrigo Antonio Carvalho', 'Initials': 'RAC', 'LastName': 'Andraus', 'Affiliation': 'Program Stricto Sensu in Rehabilitation Sciences, Research and Postgraduate Center, UNOPAR/UEL, Londrina, Brazil.'}]",Lasers in medical science,['10.1007/s10103-021-03443-6']
3433,35246585,Clinical outcomes and a nomogram for de novo metastatic breast cancer with lung metastasis: a population-based study.,"To better understand the clinical characteristics of newly diagnosed lung metastatic breast cancer (LMBC) and quantify its prognosis, we retrieved data on patients with LMBC from the Surveillance, Epidemiology, and End Results database. Eligible patients were randomly assigned to training and validation cohorts (ratio 7:3) to establish a nomogram using the Cox proportional hazards regression model. In total, 4310 patients with LMBC were enrolled, including 52.4% (2259/4310) HR+/HER2-, 17.6% (757/4310) HR+/HER2+, 10.8% (467/4310) HR-/HER2+, and 19.2% (827/4310) HR-/HER2- subtype patients. Inclinations of lung and brain involvement in HR-/HER2+ and HR-/HER2- subgroups, liver involvement in the HER2 overexpressing subgroup, and bone involvement in the HR-positive subgroup were detected in the LMBC population. Regarding prognosis, HR+/HER2+ subtype patients presented the most favorable profile (mOS 35.0 months, 95% CI 30.1-39.9), while HR-/HER2- patients exhibited the worst (mOS 11.0 months, 95% CI, 10.0-11.9). A nomogram was developed in the training cohort and validated internally (C-index 0.70) and externally (C-index 0.71), suggestive of decent performance. This study assessed the clinical outcomes associated with molecular subtypes, metastatic patterns, and surgical intervention and provided a robust nomogram for the estimation of survival probabilities, which are promising for the management of LMBC in clinical practice.",2022,"Regarding prognosis, HR+/HER2+ subtype patients presented the most favorable profile (mOS 35.0 months, 95% CI 30.1-39.9), while HR-/HER2- patients exhibited the worst (mOS 11.0 months, 95% CI, 10.0-11.9).","['Eligible patients', 'newly diagnosed lung metastatic breast cancer (LMBC', 'de novo metastatic breast cancer with lung metastasis', '4310 patients with LMBC were enrolled, including 52.4% (2259/4310) HR+/HER2-, 17.6% (757/4310) HR+/HER2+, 10.8% (467/4310) HR-/HER2+, and 19.2% (827/4310) HR-/HER2- subtype patients']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}]",[],[],4310.0,0.15453,"Regarding prognosis, HR+/HER2+ subtype patients presented the most favorable profile (mOS 35.0 months, 95% CI 30.1-39.9), while HR-/HER2- patients exhibited the worst (mOS 11.0 months, 95% CI, 10.0-11.9).","[{'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'China Rehabilitation Research Center, Beijing Boai hospital, Beijing, China.'}, {'ForeName': 'Yiqun', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. hanyiqun803@163.com.'}]",Scientific reports,['10.1038/s41598-022-07565-x']
3434,35246565,"Effect of low-level light therapy in patients with dry eye: a prospective, randomized, observer-masked trial.","To evaluate the efficacy of low-level light therapy (LLLT) with near-infrared light-emitting diodes (LED-LLLT) for the treatment of dry eye. 40 patients were randomly assigned with a 1:1 allocation ratio to receive LED-LLLT (LLLT group, n = 20) or placebo treatment (placebo group, n = 20). Patients in the LLLT group received LLLT twice a week for 3 weeks, for a total of 6 treatment sessions. The primary endpoint was the changes in the fluorescein corneal staining (FCS) score. The secondary endpoints were the changes in the ocular surface disease index (OSDI) score, lissamine green conjunctival staining (LGCS) scores, tear film break-up time (TBUT), Schirmer test, and the meibomian gland dysfunction (MGD) index. These were evaluated before treatment and 4 weeks after start of treatment. The mean difference of score change in primary endpoint revealed significant improvement in the LLLT group, compared to the placebo. Among secondary endpoints, LGCS, Schirmer's test, upper meibography scores showed significant improvements, while TBUT, lid debris, lid swelling, lid telangiectasia, meibomian gland secretion and expressibility scores had slight improvement without significant differences. No serious adverse events were observed. The use of LED-LLLT for the treatment of dry eye and MGD appears to be safe and beneficial.",2022,"Among secondary endpoints, LGCS, Schirmer's test, upper meibography scores showed significant improvements, while TBUT, lid debris, lid swelling, lid telangiectasia, meibomian gland secretion and expressibility scores had slight improvement without significant differences.","['patients with dry eye', 'dry eye', '40 patients']","['LLLT', 'placebo', 'LED-LLLT', 'low-level light therapy (LLLT) with near-infrared light-emitting diodes (LED-LLLT', 'LED-LLLT (LLLT group, n\u2009=\u200920) or placebo treatment (placebo', 'low-level light therapy']","['fluorescein corneal staining (FCS) score', 'serious adverse events', ""LGCS, Schirmer's test, upper meibography scores"", 'ocular surface disease index (OSDI) score, lissamine green conjunctival staining (LGCS) scores, tear film break-up time (TBUT), Schirmer test, and the meibomian gland dysfunction (MGD) index', 'TBUT, lid debris, lid swelling, lid telangiectasia, meibomian gland secretion and expressibility scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0524167', 'cui_str': 'Lead measurement'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0021431', 'cui_str': 'Infrared radiation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C3203718', 'cui_str': 'Conjunctival staining'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",40.0,0.102012,"Among secondary endpoints, LGCS, Schirmer's test, upper meibography scores showed significant improvements, while TBUT, lid debris, lid swelling, lid telangiectasia, meibomian gland secretion and expressibility scores had slight improvement without significant differences.","[{'ForeName': 'Yuli', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, Dankook University Hospital, College of Medicine, Dankook University, Cheonan, Republic of Korea.'}, {'ForeName': 'Hoon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Dankook University Hospital, College of Medicine, Dankook University, Cheonan, Republic of Korea.'}, {'ForeName': 'Sehwan', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Biomedical Engineering, School of Medicine, Dankook University, Cheonan, Republic of Korea.'}, {'ForeName': 'Kyong Jin', 'Initials': 'KJ', 'LastName': 'Cho', 'Affiliation': 'Department of Ophthalmology, Dankook University Hospital, College of Medicine, Dankook University, Cheonan, Republic of Korea. perfectcure@hanmail.net.'}]",Scientific reports,['10.1038/s41598-022-07427-6']
3435,35246561,The impact of healthcare reform on the dynamic changes in health service utilization and equity: a 10-year follow-up study.,"In the past decade, the government of China has implemented healthcare reforms to provide universal access to healthcare by 2020. We aimed to systematically analyse the dynamic changes in health services and equity during the past 10 years to understand the correlation between health services and social-economic status. We performed a longitudinal study in which we extracted aggregated data mainly from a project (2009, 2011, 2012, 2015, 2019). A multi-stage stratified cluster randomized design was used to obtain a representative sample in each county. Concentration indexes were used to analyse the equity of the changes in utilization. We built multivariate random-effects generalized least squares regression models with the panel data to test whether the rate of receiving a medical consultation in the last 2 weeks or the rate of hospital admission or the prevalence of chronic illness was associated with social-economic status including education level and rural disposable income per capita. We found declines in both the rate of not receiving a medical consultation during the last 2 weeks (P < 0.05 intervention group) and the rate of hospital avoidance (P < 0.05) from 2009 to 2019. The equity in residents' health service utilization has improved constantly. We additionally found that rural disposable income per capita is a protective factor for the rate of a receiving a medical consultation during the last 2 weeks and the rate of hospital admission. China's 2009 healthcare reform have positively influenced utilization rates and equity in health service utilization in the past decade, a range of health service-targeted strategies are needed including strengthen the prevention and treatment of chronic diseases, focus attention on the health status of elderly residents and improve social-economic status, especially the level of education.",2022,We additionally found that rural disposable income per capita is a protective factor for the rate of a receiving a medical consultation during the last 2 weeks and the rate of hospital admission.,"['extracted aggregated data mainly from a project (2009, 2011, 2012, 2015, 2019']",[],"['rate of not receiving a medical consultation', 'rate of hospital avoidance']","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]",[],"[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",,0.0589375,We additionally found that rural disposable income per capita is a protective factor for the rate of a receiving a medical consultation during the last 2 weeks and the rate of hospital admission.,"[{'ForeName': 'Wenqin', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'School of Public Health and Management, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Gangjun', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'School of Public Health and Management, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'School of Public Health and Management, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Baokai', 'Initials': 'B', 'LastName': 'Gao', 'Affiliation': 'School of Public Health and Management, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Wenlong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'School of Public Health and Management, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Zhaoyan', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'School of Public Health and Management, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'School of Public Health and Management, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': 'School of Public Health and Management, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Qiao', 'Affiliation': 'School of Public Health and Management, Ningxia Medical University, Yinchuan, China. qiaohui71@163.com.'}]",Scientific reports,['10.1038/s41598-022-07405-y']
3436,35246497,Alveolar Ventilation-Targeted vs. Spontaneous/Timed Mode for Home Non-Invasive Ventilation in Amyotrophic Lateral Sclerosis.,"Introduction:  Home noninvasive ventilation (NIV) is increasingly used in ALS to improve symptoms and survival. Our primary objective was to compare iVAPS vs. ST modes regarding time to first change in ventilator parameters and the number of interventions over 6 months in subjects with ALS in a respiratory therapist (RT)-led program. Methods:  In this study, 30 subjects with ALS meeting criteria for NIV initiation were randomized to iVAPS or ST. NIV was initiated using standardized protocols targeting optimal tidal volume and comfort in a daytime session. ""Download"" data was recorded at 1 week, 1 and 6 months. Any changes in ventilator parameters were recorded. Results:  Of the 30 subjects, 56.7% had bulbar onset ALS, 8 died and 11 in each group completed the study. Median time to first parameter change was 33.5 (IQR:7.7-96) vs. 41 (IQR: 12.5-216.5) days for iVAPS vs. ST groups, respectively ( P  = 0.48). The average number of RT interventions was similar between groups (1.1±1.1 vs 0.9±0.9 at 1 month,  P  = 0.72; 2.4±2.1 vs 2.4±2.3 at 6 months,  P  = 0.95; for iVAPS vs ST respectively). Adherence was significantly lower with iVAPS than ST at 1 week, but not at 1 or 6 months. Download parameters were similar between groups at 1 week and 6 months, except for higher residual apnea-hypopnea index (AHI) and less spontaneously triggered breaths with iVAPS at 6 months. Conclusions:  The time to first change of parameters and the number of interventions at 6 months from NIV initiation were similar for the iVAPS and ST modes in subjects with ALS. With iVAPS, adherence was lower transiently at NIV initiation, and the residual AHI was higher at 6 months. Alveolar ventilation-targeted NIV may require a longer adaptation period and result in greater upper airway instability in predominantly bulbar ALS subjects.",2022,"Download parameters were similar between groups at 1 week and 6 months, except for higher residual apnea-hypopnea index (AHI) and less spontaneously triggered breaths with iVAPS at 6 months.","['30 subjects with ALS meeting criteria for NIV initiation', 'subjects with ALS', 'Amyotrophic Lateral Sclerosis', 'predominantly bulbar ALS subjects']","['Alveolar Ventilation-Targeted vs. Spontaneous/Timed Mode for Home Non-Invasive Ventilation', 'Alveolar ventilation-targeted NIV', 'iVAPS or ST', 'Introduction:  Home noninvasive ventilation (NIV']","['average number of RT interventions', 'bulbar onset ALS', 'residual AHI', 'ventilator parameters', 'residual apnea-hypopnea index (AHI', 'Adherence', 'Download"" data', 'Median time to first parameter change']","[{'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}]","[{'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",30.0,0.0117043,"Download parameters were similar between groups at 1 week and 6 months, except for higher residual apnea-hypopnea index (AHI) and less spontaneously triggered breaths with iVAPS at 6 months.","[{'ForeName': 'Pattaraporn', 'Initials': 'P', 'LastName': 'Panyarath', 'Affiliation': 'Respiratory Division and Sleep Laboratory McGill University Health Centre (MUHC), Montreal, Quebec, Canada.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Adam', 'Affiliation': 'Quebec National Program for Home Ventilatory Assistance (NPHVA), MUHC, Montreal, Quebec, Canada.'}, {'ForeName': 'R John', 'Initials': 'RJ', 'LastName': 'Kimoff', 'Affiliation': 'Respiratory Division and Sleep Laboratory McGill University Health Centre (MUHC), Montreal, Quebec, Canada.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Kaminska', 'Affiliation': 'Respiratory Division and Sleep Laboratory McGill University Health Centre (MUHC), Montreal, Quebec, Canada.'}]",Respiratory care,['10.4187/respcare.09580']
3437,35246470,Evaluation of response to 13-valent conjugated pneumococcal vaccination in patients with rheumatoid arthritis receiving upadacitinib: results from a phase 2 open-label extension study.,"OBJECTIVE


To assess the immunogenicity of pneumococcal 13-valent conjugate vaccination (PCV-13) in patients with rheumatoid arthritis receiving upadacitinib and background methotrexate (MTX).
METHODS


Eligible patients from the phase 2 open-label extension trial BALANCE-EXTEND (NCT02049138) receiving stable dosing of upadacitinib 15 mg or 30 mg once daily plus background MTX were given PCV-13. Antibody titres were collected prevaccination and 4 and 12 weeks postvaccination. The primary endpoint was the proportion of patients with satisfactory humoral response to PCV-13, defined as a ≥2-fold increase in ≥6 of 12 pneumococcal antigens at 4 weeks postvaccination.
RESULTS


Of 111 patients (upadacitinib 15 mg, N=87; 30 mg, N=24), 85.6% were women, 97.3% used concomitant MTX and 44.1% used oral corticosteroids. At 4 weeks, 67.5% (95% CI 57.4 to 77.5) of patients receiving upadacitinib 15 mg and 56.5% (36.3 to 76.8) receiving 30 mg had a satisfactory PCV-13 response. Responses were similar in patients who used or did not use concomitant corticosteroids. No deaths or serious adverse events were reported.
CONCLUSIONS


Approximately two-thirds of patients receiving upadacitinib 15 mg once daily achieved a satisfactory humoral response to PCV-13 despite receiving concomitant MTX. Concomitant corticosteroid use did not negatively affect PCV-13 response.",2022,"At 4 weeks, 67.5% (95% CI 57.4 to 77.5) of patients receiving upadacitinib 15 mg and 56.5% (36.3 to 76.8) receiving 30 mg had a satisfactory PCV-13 response.","['patients with rheumatoid arthritis receiving upadacitinib', '111 patients', 'patients with rheumatoid arthritis receiving upadacitinib and background methotrexate (MTX', 'Eligible patients from the phase 2 open-label extension trial']","['MTX', 'upadacitinib 15\u2009mg or 30\u2009mg once daily plus background MTX were given PCV-13', 'oral corticosteroids', 'pneumococcal 13-valent conjugate vaccination (PCV-13', '13-valent conjugated pneumococcal vaccination']","['proportion of patients with satisfactory humoral response to PCV-13, defined as a ≥2-fold increase in ≥6 of 12 pneumococcal antigens', 'deaths or serious adverse events', 'satisfactory PCV-13 response', 'Antibody titres', 'satisfactory humoral response', 'PCV-13 response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C5196293', 'cui_str': 'upadacitinib 15 MG [Rinvoq]'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0419707', 'cui_str': 'Pneumococcal vaccination'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",111.0,0.0596162,"At 4 weeks, 67.5% (95% CI 57.4 to 77.5) of patients receiving upadacitinib 15 mg and 56.5% (36.3 to 76.8) receiving 30 mg had a satisfactory PCV-13 response.","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Winthrop', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA winthrop@ohsu.edu.'}, {'ForeName': 'Juan Ignacio', 'Initials': 'JI', 'LastName': 'Vargas', 'Affiliation': 'Medicine, Quantum Research, Puerto Varas, Los Lagos, Chile.'}, {'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Drescher', 'Affiliation': 'Rheumatology, Veszprém Csolnoky Ferenc County Hospital, Veszprém, Hungary.'}, {'ForeName': 'Conrado', 'Initials': 'C', 'LastName': 'Garcia', 'Affiliation': 'Rheumatology Unit, Hospital General de México Dr Eduardo Liceaga, Mexico City, Mexico.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Friedman', 'Affiliation': 'Immunology, AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hendrickson', 'Affiliation': 'Immunology, AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Yihan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Immunology, AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Klaff', 'Affiliation': 'Immunology, AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA.'}]",RMD open,['10.1136/rmdopen-2021-002110']
3438,35247334,"A randomized, double-masked, multicenter trial of topical acrizanib (LHA510), a tyrosine kinase VEGF-receptor inhibitor, in treatment-experienced subjects with neovascular age-related macular degeneration.","PURPOSE


To evaluate whether topical acrizanib (LHA510), a small molecule vascular endothelial growth factor receptor (VEGFR) inhibitor, could suppress the need for anti-VEGF therapy over a 12-week period in patients with neovascular age-related macular degeneration (nAMD) DESIGN: A phase 2 multicenter randomized double masked, vehicle-controlled proof of concept study METHODS: Trial includes n = 90 patients with active choroidal neovascularization due to nAMD and under anti-VEGF treatment. All patients received an intravitreal injection of ranibizumab at baseline and were re-treated when there was evidence of disease recurrence (rescue). Patients were randomized 1:1 to receive topical LHA510 or vehicle for 12 weeks. Drops were administered twice a day for 8 weeks and then three times a day for the last 4 weeks MAIN OUTCOME MEASURE: The primary outcome was the number of patients requiring rescue over 84 days of topical dosing. Key secondary outcome measures were time to first rescue, total number of ranibizumab injections, changes in central subfield thickness (CSFT) and changes of visual acuity from baseline to Day 84.
RESULTS


The extended per protocol set included seventy patients of whom 25 of 33 patients in the LHA510 group (75.8%) and 25 of 37 patients in the placebo group (67.6%) required rescue by Day 84 (p = 0.8466). Secondary and subgroup analysis did not support evidence of efficacy. Twenty-one of 46 patients administered LHA510 developed a reversible corneal haze that resolved with cessation of treatment and did not recur in patients restarted at once daily frequency CONCLUSIONS: In spite of extensive optimization for topical efficacy, LHA510 failed to demonstrate clinical efficacy.",2022,Twenty-one of 46 patients administered LHA510 developed a reversible corneal haze that resolved with cessation of treatment and did not recur in patients restarted at once daily frequency CONCLUSIONS:,"['patients with neovascular age-related macular degeneration (nAMD) DESIGN', 'seventy patients of whom 25 of 33 patients in the LHA510 group (75.8%) and 25 of 37 patients in the', ' Trial includes n\u202f=\u202f90 patients with active choroidal neovascularization due to nAMD and under anti-VEGF treatment', 'subjects with neovascular age-related macular degeneration']","['intravitreal injection of ranibizumab', 'placebo', 'LHA510', 'topical LHA510', 'topical acrizanib (LHA510', 'topical acrizanib (LHA510), a tyrosine kinase VEGF-receptor inhibitor']","['number of patients requiring rescue over 84 days of topical dosing', 'efficacy', 'time to first rescue, total number of ranibizumab injections, changes in central subfield thickness (CSFT) and changes of visual acuity', 'reversible corneal haze']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C4742748', 'cui_str': 'LHA510'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4742748', 'cui_str': 'LHA510'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4742747', 'cui_str': 'acrizanib'}, {'cui': 'C0033681', 'cui_str': 'Protein-tyrosine kinase'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0010038', 'cui_str': 'Corneal opacity'}]",90.0,0.742093,Twenty-one of 46 patients administered LHA510 developed a reversible corneal haze that resolved with cessation of treatment and did not recur in patients restarted at once daily frequency CONCLUSIONS:,"[{'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Poor', 'Affiliation': 'Translational Medicine / Research. Electronic address: stephen.poor@novartis.com.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Weissgerber', 'Affiliation': 'Clinical Development, Basel, Switzerland.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Adams', 'Affiliation': 'Global Discovery Chemistry.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Harit Bhatt', 'Affiliation': 'Retina and Macula Associates, Oak Forest, IL, USA; University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Browning', 'Affiliation': 'Charlotte Eye, Ear, Nose, and Throat Associates, Charlotte, NC.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chastain', 'Affiliation': 'PK sciences.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Ciulla', 'Affiliation': 'Clearside Biomedical Inc., Alpharetta, GA USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ferriere', 'Affiliation': 'Clinical Data Operations.'}, {'ForeName': 'Kinfemichael', 'Initials': 'K', 'LastName': 'Gedif', 'Affiliation': 'Biostatistician, Novartis Pharma Inc.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Louis C Glazer', 'Affiliation': 'Vitreo-Retinal Associates, Grand Rapids, Michigan, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Joondeph', 'Affiliation': 'Colorado Retina Associates, Denver, Colorado.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Normand', 'Affiliation': 'Clinical Development, East Hanover, NJ, USA, Ft Worth, Texas, USA.'}, {'ForeName': 'Veeral', 'Initials': 'V', 'LastName': 'Sheth', 'Affiliation': 'Retina and Macula Associates, Oak Forest, IL, USA; University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Christie', 'Initials': 'C', 'LastName': 'Watters', 'Affiliation': 'Biostatistician, Novartis Institutes for Biomedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Grosskreutz', 'Affiliation': 'Biostatistician, Novartis Institutes for Biomedical Research, Cambridge, MA, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2022.02.019']
3439,35247321,"Safety, pharmacokinetics, and antimalarial activity of the novel triaminopyrimidine ZY-19489: a first-in-human, randomised, placebo-controlled, double-blind, single ascending dose study, pilot food-effect study, and volunteer infection study.","BACKGROUND


New antimalarials with novel mechanisms of action are needed to combat the emergence of drug resistance. Triaminopyrimidines comprise a novel antimalarial class identified in a high-throughput screen against asexual blood-stage Plasmodium falciparum. This first-in-human study aimed to characterise the safety, pharmacokinetics, and antimalarial activity of the triaminopyrimidine ZY-19489 in healthy volunteers.
METHODS


A three-part clinical trial was conducted in healthy adults (aged 18-55 years) in Brisbane, QLD, Australia. Part one was a double-blind, randomised, placebo-controlled, single ascending dose study in which participants enrolled into one of six dose groups (25, 75, 150, 450, 900, or 1500 mg) were randomly assigned (3:1) to ZY-19489 or placebo. Part two was an open-label, randomised, two-period cross-over, pilot food-effect study in which participants were randomly assigned (1:1) to a fasted-fed or a fed-fasted sequence. Part three was an open-label, randomised, volunteer infection study using the P falciparum induced blood-stage malaria model in which participants were enrolled into one of two cohorts, with participants in cohort one all receiving the same dose of ZY-19489 and participants in cohort two randomly assigned to receive one of two doses. The primary outcome for all three parts was the incidence, severity, and relationship to ZY-19489 of adverse events. Secondary outcomes were estimation of ZY-19489 pharmacokinetic parameters for all parts; how these parameters were affected by the fed state for part two only; and the parasite reduction ratio, parasite clearance half-life, recrudescent parasitaemia, and pharmacokinetic-pharmacodynamic modelling parameters for part three only. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619000127101, ACTRN12619001466134, and ACTRN12619001215112).
FINDINGS


48 participants were enrolled in part one (eight per cohort for 25-1500 mg cohorts), eight in part two (four in each group, all dosed with 300 mg), and 15 in part three (five dosed with 200 mg, eight with 300 mg, and two with 900 mg). In part one, the incidence of drug-related adverse events was higher in the 1500 mg dose group (occurring in all six participants) than in lower-dose groups and the placebo group (occurring in one of six in the 25 mg group, two of six in the 75 mg group, three of six in the 150 mg group, two of six in the 450 mg group, four of six in the 900 mg group, and four of 12 in the placebo group), due to the occurrence of mild gastrointestinal symptoms. Maximum plasma concentrations occurred 5-9 h post-dosing, and the elimination half-life was 50-97 h across the dose range. In part two, three of seven participants had a treatment-related adverse event in the fed state and four of eight in the fasted state. Dosing in the fed state delayed absorption (maximum plasma concentration occurred a median of 12·0 h [range 7·5-16·0] after dosing in the fed state vs 6·0 h [4·5-9·1] in the fasted state) but had no effect on overall exposure (difference in area under the concentration-time curve from time 0 [dosing] extrapolated to infinity between fed and fasted states was -0·013 [90% CI -0·11 to 0·08]). In part three, drug-related adverse events occurred in four of five participants in the 200 mg group, seven of eight in the 300 mg group, and both participants in the 900 mg group. Rapid initial parasite clearance occurred in all participants following dosing (clearance half-life 6·6 h [95% CI 6·2-6·9] for 200 mg, 6·8 h [95% CI 6·5-7·1] for 300 mg, and 7·1 h [95% CI 6·6-7·6] for 900 mg). Recrudescence occurred in four of five participants in the 200 mg group, five of eight in the 300 mg group, and neither of the two participants in the 900 mg group. Simulations done using a pharmacokinetic-pharmacodynamic model predicted that a single dose of 1100 mg would clear baseline parasitaemia by a factor of 10 9 .
INTERPRETATION


The safety, pharmacokinetic profile, and antimalarial activity of ZY-19489 in humans support the further development of the compound as a novel antimalarial therapy.
FUNDING


Cadila Healthcare and Medicines for Malaria Venture.",2022,Rapid initial parasite clearance occurred in all participants following dosing (clearance half-life 6·6 h,"['healthy adults (aged 18-55 years) in Brisbane, QLD, Australia', '48 participants were enrolled in part one (eight per cohort for 25-1500 mg cohorts', 'participants enrolled into one of six dose groups (25, 75, 150, 450, 900, or 1500 mg', 'healthy volunteers']","['Triaminopyrimidines', 'ZY-19489 or placebo', 'placebo', 'fasted-fed or a fed-fasted sequence', 'triaminopyrimidine ZY-19489']","['Maximum plasma concentrations', 'safety, pharmacokinetic profile, and antimalarial activity', 'parasite reduction ratio, parasite clearance half-life, recrudescent parasitaemia, and pharmacokinetic-pharmacodynamic modelling parameters', 'mild gastrointestinal symptoms', 'incidence, severity, and relationship to ZY-19489 of adverse events', 'incidence of drug-related adverse events', 'Rapid initial parasite clearance', 'estimation of ZY-19489 pharmacokinetic parameters', 'adverse events', 'Recrudescence', 'Safety, pharmacokinetics, and antimalarial activity', 'safety, pharmacokinetics, and antimalarial activity', 'absorption (maximum plasma concentration']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0086898', 'cui_str': 'Recrudescence'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]",48.0,0.304192,Rapid initial parasite clearance occurred in all participants following dosing (clearance half-life 6·6 h,"[{'ForeName': 'Bridget E', 'Initials': 'BE', 'LastName': 'Barber', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fernandez', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Hardik Babubhai', 'Initials': 'HB', 'LastName': 'Patel', 'Affiliation': 'Zydus Research Centre, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Barcelo', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Woolley', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia; Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Harilal', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Zydus Research Centre, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Llewellyn', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Azrin N', 'Initials': 'AN', 'LastName': 'Abd-Rahman', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Zydus Research Centre, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Jain', 'Affiliation': 'Zydus Research Centre, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Ghoghari', 'Affiliation': 'Zydus Research Centre, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Di Resta', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Fuchs', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland; AC Immune SA, Lausanne, Switzerland.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Deni', 'Affiliation': 'Department of Microbiology and Immunology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Yeo', 'Affiliation': 'Department of Microbiology and Immunology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Sachel', 'Initials': 'S', 'LastName': 'Mok', 'Affiliation': 'Department of Microbiology and Immunology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Fidock', 'Affiliation': 'Department of Microbiology and Immunology, Columbia University Irving Medical Center, New York, NY, USA; Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Chalon', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Jörg J', 'Initials': 'JJ', 'LastName': 'Möhrle', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Deven', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Zydus Research Centre, Ahmedabad, Gujarat, India.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'McCarthy', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia; The Peter Doherty Institute for Infection and Immunity, The University of Melbourne and the Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Kevinkumar', 'Initials': 'K', 'LastName': 'Kansagra', 'Affiliation': 'Zydus Research Centre, Ahmedabad, Gujarat, India. Electronic address: kevinkumarkansagra@zyduscadila.com.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(21)00679-4']
3440,35247264,Efficacy of Bacillus Calmette-Guérin vaccination against respiratory tract infections in the elderly during the Covid-19 pandemic.,"BACKGROUND


Older age is associated with increased severity and death from respiratory infections, including coronavirus disease 2019 (Covid-19). The tuberculosis vaccine Bacille Calmette-Guérin (BCG) may provide heterologous protection against non-tuberculous infections, and has been proposed as a potential preventive strategy against Covid-19.
METHODS


In this multicenter, placebo-controlled trial, we randomly assigned elderly individuals (60 years or older, n=2014) to intracutaneous vaccination with BCG (n=1008) or placebo (n=1006). The primary endpoint was the cumulative incidence of respiratory tract infections that required medical intervention, during 12 months of follow-up. Secondary endpoints included the incidence of Covid-19, and the effect of BCG vaccination on the cellular and humoral immune responses.
RESULTS


The cumulative incidence of respiratory tract infection requiring medical intervention was 0.029 in the BCG-vaccinated group and 0.024 in the control group (subdistribution hazard ratio [SHR], 1.26; 98.2% confidence interval [CI], 0.65 to 2.44). 51 and 48 individuals tested positive for SARS-CoV-2 by PCR in the BCG and placebo group, respectively (SHR, 1.053; 95% CI, 0.71 to 1.56). No difference was observed in the frequency of adverse events. BCG vaccination was associated with enhanced cytokines responses after influenza, and partially also after SARS-CoV-2 stimulation. In patients diagnosed with Covid-19, antibody responses after infection were significantly stronger if the volunteers had previously received BCG.
CONCLUSIONS


BCG-vaccination had no effect on the incidence of respiratory tract infections, including SARS-CoV-2 infection, in elderly volunteers. However, BCG vaccination improved cytokine responses stimulated by influenza and SARS-CoV-2, and induced stronger antibody titers after Covid-19 infection.",2022,"However, BCG vaccination improved cytokine responses stimulated by influenza and SARS-CoV-2, and induced stronger antibody titers after Covid-19 infection.","['n=1006', 'elderly volunteers', 'elderly individuals (60 years or older, n=2014) to intracutaneous vaccination with BCG (n=1008) or', 'elderly during the Covid-19 pandemic']","['Bacillus Calmette-Guérin vaccination', 'placebo', 'tuberculosis vaccine Bacille Calmette-Guérin (BCG']","['frequency of adverse events', 'incidence of Covid-19, and the effect of BCG vaccination on the cellular and humoral immune responses', 'cytokine responses', 'enhanced cytokines responses', 'incidence of respiratory tract infections', 'cumulative incidence of respiratory tract infection requiring medical intervention', 'cumulative incidence of respiratory tract infections']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041305', 'cui_str': 'Tuberculosis vaccine'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.424632,"However, BCG vaccination improved cytokine responses stimulated by influenza and SARS-CoV-2, and induced stronger antibody titers after Covid-19 infection.","[{'ForeName': 'Simone J C F M', 'Initials': 'SJCFM', 'LastName': 'Moorlag', 'Affiliation': 'Department of Internal Medicine Radboud university medical center, Nijmegen, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Taks', 'Affiliation': 'Department of Internal Medicine Radboud university medical center, Nijmegen, the Netherlands.'}, {'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Ten Doesschate', 'Affiliation': 'University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'van der Vaart', 'Affiliation': 'University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Axel B', 'Initials': 'AB', 'LastName': 'Janssen', 'Affiliation': 'University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Müller', 'Affiliation': 'Department for Pediatric Oncology, Hematology and Clinical Immunology, University Hospital Duesseldorf, Medical Faculty, Heinrich Heine University Duesseldorf, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Ostermann', 'Affiliation': 'Department for Pediatric Oncology, Hematology and Clinical Immunology, University Hospital Duesseldorf, Medical Faculty, Heinrich Heine University Duesseldorf, Germany.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Internal Medicine Radboud university medical center, Nijmegen, the Netherlands.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Lemmers', 'Affiliation': 'Department of Internal Medicine Radboud university medical center, Nijmegen, the Netherlands.'}, {'ForeName': 'Elles', 'Initials': 'E', 'LastName': 'Simonetti', 'Affiliation': 'Radboud Center for Infectious Diseases, Radboud university medical center, Nijmegen, the Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Mazur', 'Affiliation': 'University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Heiner', 'Initials': 'H', 'LastName': 'Schaal', 'Affiliation': 'Department for Pediatric Oncology, Hematology and Clinical Immunology, University Hospital Duesseldorf, Medical Faculty, Heinrich Heine University Duesseldorf, Germany.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Ter Heine', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, the Netherlands.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'van de Veerdonk', 'Affiliation': 'Department of Internal Medicine Radboud university medical center, Nijmegen, the Netherlands.'}, {'ForeName': 'Chantal P', 'Initials': 'CP', 'LastName': 'Bleeker-Rovers', 'Affiliation': 'Department of Internal Medicine Radboud university medical center, Nijmegen, the Netherlands.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Department of Internal Medicine Radboud university medical center, Nijmegen, the Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Ten Oever', 'Affiliation': 'Department of Internal Medicine Radboud university medical center, Nijmegen, the Netherlands.'}, {'ForeName': 'Marien I', 'Initials': 'MI', 'LastName': 'de Jonge', 'Affiliation': 'Radboud Center for Infectious Diseases, Radboud university medical center, Nijmegen, the Netherlands.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Bonten', 'Affiliation': 'University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Cornelis H', 'Initials': 'CH', 'LastName': 'van Werkhoven', 'Affiliation': 'University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine Radboud university medical center, Nijmegen, the Netherlands.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciac182']
3441,35247245,Therapeutic Effects of Small Incision Open Reduction and Internal Fixation and Arthroscopic High Strength Non-Absorbable Suture on Tibial Insertion Avulsion Fracture of the Anterior Cruciate Ligament.,"PURPOSE OF THE STUDY To evaluate the therapeutic effects of small incision open reduction and internal fixation and arthroscopic high strength non-absorbable suture on tibial insertion avulsion fracture of the anterior cruciate ligament (ACL). MATERIAL AND METHODS In this prospectively study, 72 patients with ACL tibial insertion avulsion fracture treated from December 2017 to June 2020 were enrolled and divided into group A (treated with small incision open reduction and cannulated screw internal fixation) and group B (treated with arthroscopic high strength non-absorbable suture) using a random number table (n=36). Their general data, surgical indices and incidence of postoperative adverse reactions were compared. Knee function indices were compared before and after treatment, and evaluated by random walk model. RESULTS No significant differences were found in the general data, intraoperative blood loss, preoperative Lysholm score, International Knee Documentation Committee (IKDC) score, Tegner score, knee range of motion and difference of bilateral tibial forward displacement distance, and total incidence rate of postoperative adverse reactions between the two groups (P>0.05). Group B had significantly longer operation time, and significantly shorter hospital stay, time of first ambulation after operation and bone healing time than group A (P<0.05). Both groups had improved Lysholm score, IKDC score, Tegner score and knee range of motion after treatment, especially in group B (P<0.05). The difference of bilateral tibial forward displacement distance significantly reduced in both groups after treatment, particularly in group B (P<0.05). The random walk model revealed that group B had better improvement of knee function than group A. CONCLUSIONS Arthroscopic high strength non-absorbable suture in the treatment of ACL tibial insertion avulsion fracture can dramatically improve the knee function indices of patients, with rapid recovery and high safety, so it has a broad prospect of clinical application. Key words: small incision open reduction and internal fixation, arthroscopic high strength non-absorbable suture, tibial insertion avulsion fracture, anterior cruciate ligament, random walk model.",2022,"Both groups had improved Lysholm score, IKDC score, Tegner score and knee range of motion after treatment, especially in group B (P<0.05).","['tibial insertion avulsion fracture of the anterior cruciate ligament (ACL', 'Tibial Insertion Avulsion Fracture of the Anterior Cruciate Ligament', '72 patients with ACL tibial insertion avulsion fracture treated from December 2017 to June 2020']","['small incision open reduction and internal fixation, arthroscopic high strength non-absorbable suture, tibial insertion avulsion fracture, anterior cruciate ligament, random walk model', 'Small Incision Open Reduction and Internal Fixation and Arthroscopic High Strength Non-Absorbable Suture', 'Arthroscopic high strength non-absorbable suture', 'small incision open reduction and cannulated screw internal fixation) and group B (treated with arthroscopic high strength non-absorbable suture', 'small incision open reduction and internal fixation and arthroscopic high strength non-absorbable suture']","['bilateral tibial forward displacement distance', 'knee function', 'general data, intraoperative blood loss, preoperative Lysholm score, International Knee Documentation Committee (IKDC) score, Tegner score, knee range of motion and difference of bilateral tibial forward displacement distance, and total incidence rate of postoperative adverse reactions', 'Knee function indices', 'shorter hospital stay, time of first ambulation after operation and bone healing time', 'Lysholm score, IKDC score, Tegner score and knee range of motion', 'longer operation time', 'postoperative adverse reactions']","[{'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332758', 'cui_str': 'Avulsion fracture'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0461628', 'cui_str': 'Non-absorbable suture'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332758', 'cui_str': 'Avulsion fracture'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",72.0,0.0102698,"Both groups had improved Lysholm score, IKDC score, Tegner score and knee range of motion after treatment, especially in group B (P<0.05).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Second Ward of Sports Injuries and Arthroscopy, Tianjin Hospital, Tianjin, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Second Ward of Sports Injuries and Arthroscopy, Tianjin Hospital, Tianjin, China.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ren', 'Affiliation': 'Second Ward of Sports Injuries and Arthroscopy, Tianjin Hospital, Tianjin, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Second Ward of Sports Injuries and Arthroscopy, Tianjin Hospital, Tianjin, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Second Ward of Sports Injuries and Arthroscopy, Tianjin Hospital, Tianjin, China.'}]",Acta chirurgiae orthopaedicae et traumatologiae Cechoslovaca,[]
3442,35247098,"Impact of wheat aleurone on biomarkers of cardiovascular disease, gut microbiota and metabolites in adults with high body mass index: a double-blind, placebo-controlled, randomized clinical trial.","PURPOSE


Aleurone is a cereal bran fraction containing a variety of beneficial nutrients including polyphenols, fibers, minerals and vitamins. Animal and human studies support the beneficial role of aleurone consumption in reducing cardiovascular disease (CVD) risk. Gut microbiota fiber fermentation, polyphenol metabolism and betaine/choline metabolism may in part contribute to the physiological effects of aleurone. As primary objective, this study evaluated whether wheat aleurone supplemented foods could modify plasma homocysteine. Secondary objectives included changes in CVD biomarkers, fecal microbiota composition and plasma/urine metabolite profiles.
METHODS


A parallel double-blind, placebo-controlled and randomized trial was carried out in two groups of obese/overweight subjects, matched for age, BMI and gender, consuming foods supplemented with either aleurone (27 g/day) (AL, n = 34) or cellulose (placebo treatment, PL, n = 33) for 4 weeks.
RESULTS


No significant changes in plasma homocysteine or other clinical markers were observed with either treatment. Dietary fiber intake increased after AL and PL, animal protein intake increased after PL treatment. We observed a significant increase in fecal Bifidobacterium spp with AL and Lactobacillus spp with both AL and PL, but overall fecal microbiota community structure changed little according to 16S rRNA metataxonomics. Metabolomics implicated microbial metabolism of aleurone polyphenols and revealed distinctive biomarkers of AL treatment, including alkylresorcinol, cinnamic, benzoic and ferulic acids, folic acid, fatty acids, benzoxazinoid and roasted aroma related metabolites. Correlation analysis highlighted bacterial genera potentially linked to urinary compounds derived from aleurone metabolism and clinical parameters.
CONCLUSIONS


Aleurone has potential to modulate the gut microbial metabolic output and increase fecal bifidobacterial abundance. However, in this study, aleurone did not impact on plasma homocysteine or other CVD biomarkers.
TRIAL REGISTRATION


The study was registered at ClinicalTrials.gov (NCT02067026) on the 17th February 2014.",2022,"We observed a significant increase in fecal Bifidobacterium spp with AL and Lactobacillus spp with both AL and PL, but overall fecal microbiota community structure changed little according to 16S rRNA metataxonomics.","['two groups of obese/overweight subjects, matched for age, BMI and gender, consuming foods supplemented with either aleurone (27\xa0g/day) (AL, n\u2009=\u200934) or', 'adults with high body mass index']","['wheat aleurone supplemented foods', 'cellulose (placebo treatment, PL, n\u2009=\u200933) for 4\xa0weeks', 'wheat aleurone', 'placebo']","['biomarkers of cardiovascular disease, gut microbiota and metabolites', 'gut microbial metabolic output and increase fecal bifidobacterial abundance', 'fecal Bifidobacterium spp', 'Dietary fiber intake increased after AL and PL, animal protein intake', 'changes in CVD biomarkers, fecal microbiota composition and plasma/urine metabolite profiles', 'plasma homocysteine']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4548762', 'cui_str': 'aleurone'}, {'cui': 'C0456640', 'cui_str': '27G'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C4548762', 'cui_str': 'aleurone'}, {'cui': 'C0016498', 'cui_str': 'Enriched Food'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake'}, {'cui': 'C0440447', 'cui_str': 'Animal protein'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}]",,0.489918,"We observed a significant increase in fecal Bifidobacterium spp with AL and Lactobacillus spp with both AL and PL, but overall fecal microbiota community structure changed little according to 16S rRNA metataxonomics.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fava', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach (FEM), San Michele all'Adige, Trento, Italy. francesca_fava1978@hotmail.com.""}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Ulaszewska', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach (FEM), San Michele all'Adige, Trento, Italy.""}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Scholz', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach (FEM), San Michele all'Adige, Trento, Italy.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stanstrup', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach (FEM), San Michele all'Adige, Trento, Italy.""}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Nissen', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach (FEM), San Michele all'Adige, Trento, Italy.""}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Mattivi', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach (FEM), San Michele all'Adige, Trento, Italy.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Vermeiren', 'Affiliation': 'Cargill R&D Centre Europe, Vilvoorde, Belgium.'}, {'ForeName': 'Douwina', 'Initials': 'D', 'LastName': 'Bosscher', 'Affiliation': 'Cargill R&D Centre Europe, Vilvoorde, Belgium.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Pedrolli', 'Affiliation': 'U.O.S. di Dietetica E Nutrizione Clinica, Ospedale S. Chiara, APSS, Trento, Italy.'}, {'ForeName': 'Kieran M', 'Initials': 'KM', 'LastName': 'Tuohy', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach (FEM), San Michele all'Adige, Trento, Italy.""}]",European journal of nutrition,['10.1007/s00394-022-02836-9']
3443,35247067,Reversibility of brain glucose kinetics in type 2 diabetes mellitus.,"AIMS/HYPOTHESIS


We have previously shown that individuals with uncontrolled type 2 diabetes have a blunted rise in brain glucose levels measured by  1 H magnetic resonance spectroscopy. Here, we investigate whether reductions in HbA 1c  normalise intracerebral glucose levels.
METHODS


Eight individuals (two men, six women) with poorly controlled type 2 diabetes and mean ± SD age 44.8 ± 8.3 years, BMI 31.4 ± 6.1 kg/m 2  and HbA 1c  84.1 ± 16.2 mmol/mol (9.8 ± 1.4%) underwent  1 H MRS scanning at 4 Tesla during a hyperglycaemic clamp (~12.21 mmol/l) to measure changes in cerebral glucose at baseline and after a 12 week intervention that improved glycaemic control through the use of continuous glucose monitoring, diabetes regimen intensification and frequent visits to an endocrinologist and nutritionist.
RESULTS


Following the intervention, mean ± SD HbA 1c  decreased by 24.3 ± 15.3 mmol/mol (2.1 ± 1.5%) (p=0.006), with minimal weight changes (p=0.242). Using a linear mixed-effects regression model to compare glucose time courses during the clamp pre and post intervention, the pre-intervention brain glucose level during the hyperglycaemic clamp was significantly lower than the post-intervention brain glucose (p<0.001) despite plasma glucose levels during the hyperglycaemic clamp being similar (p=0.266). Furthermore, the increases in brain glucose were correlated with the magnitude of improvement in HbA 1c  (r = 0.71, p=0.048).
CONCLUSION/INTERPRETATION


These findings highlight the potential reversibility of cerebral glucose transport capacity and metabolism that can occur in individuals with type 2 diabetes following improvement of glycaemic control. Trial registration ClinicalTrials.gov NCT03469492.",2022,"Following the intervention, mean ± SD HbA 1c  decreased by 24.3 ± 15.3 mmol/mol (2.1 ± 1.5%) (p=0.006), with minimal weight changes (p=0.242).","['individuals with uncontrolled type 2 diabetes', 'type 2 diabetes mellitus', 'Eight individuals (two men, six women) with poorly controlled type 2 diabetes and mean\u2009±\u2009SD age 44.8\u2009±\u20098.3\xa0years, BMI 31.4\u2009±\u20096.1\xa0kg/m 2  and HbA 1c  84.1\u2009±\u200916.2\xa0mmol/mol (9.8\u2009±\u20091.4%) underwent']","['1 H MRS scanning at 4 Tesla during a hyperglycaemic clamp (~12.21\xa0mmol/l) to measure changes in cerebral glucose at baseline and after a 12\xa0week intervention that improved glycaemic control through the use of continuous glucose monitoring, diabetes regimen intensification and frequent visits to an endocrinologist and nutritionist']","['brain glucose levels', 'glucose time courses', 'mean\u2009±\u2009SD HbA 1c', 'plasma glucose levels', 'brain glucose']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4319690', 'cui_str': '16.2'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517503', 'cui_str': '1.4'}]","[{'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0259863', 'cui_str': 'Endocrinologist'}, {'cui': 'C0237083', 'cui_str': 'Nutritionist'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.044178,"Following the intervention, mean ± SD HbA 1c  decreased by 24.3 ± 15.3 mmol/mol (2.1 ± 1.5%) (p=0.006), with minimal weight changes (p=0.242).","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sanchez-Rangel', 'Affiliation': 'Department of Internal Medicine/Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Felona', 'Initials': 'F', 'LastName': 'Gunawan', 'Affiliation': 'Department of Internal Medicine/Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Savoye', 'Affiliation': 'Department of Pediatric Endocrinology and General Clinical Research Center, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Dai', 'Affiliation': 'Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Coppoli', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Rothman', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Graeme F', 'Initials': 'GF', 'LastName': 'Mason', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Janice Jin', 'Initials': 'JJ', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine/Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA. Janice.hwang@yale.edu.'}]",Diabetologia,['10.1007/s00125-022-05664-y']
3444,35246982,Before-School Physical Activity Program's Impact on Social and Emotional Learning.,"BACKGROUND


Despite the positive impact of social and emotional learning (SEL) on the emotional well-being of children, literature on physical activity engagement and SEL among this population has been limited. Therefore, the purpose of this study was to examine whether school students' SEL would improve after participation in a before-school physical activity program.
METHODS


A total of 138 fourth and sixth grade students from 1 elementary school and 1 middle school participated in this study. Seventy-five students participated in the before-school physical activity program, while 63 students were in the control group. The physical education teachers implemented the program 3 days per week, for 3 weeks. The participants completed a 10-question adapted Devereux Student Strengths Assessment-Mini before and after the program. Repeated measures ANOVA was run to determine the effects of the program on SEL competence.
RESULTS


The fourth and sixth grade students who participated in the program reported a 7 and 10% improvement in pre- versus post-intervention SEL competence, respectively. Students in the control group reported no change in their SEL competence.
CONCLUSION


Considering the benefits of a before-school physical activity program on students' SEL, stakeholders should consider including more physical activity programming within school policies.",2022,"Students in the control group reported no change in their SEL competence.
","['A total of 138 fourth and sixth grade students from 1 elementary school and 1 middle school participated in this study', 'school students', 'Seventy-five students participated in the before-school physical activity program, while 63 students were in the control group']","['social and emotional learning (SEL', 'SEL']","['Social and Emotional Learning', 'SEL competence']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0582589', 'cui_str': 'Emotional learning'}]","[{'cui': 'C0582589', 'cui_str': 'Emotional learning'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",75.0,0.015232,"Students in the control group reported no change in their SEL competence.
","[{'ForeName': 'Tan Leng', 'Initials': 'TL', 'LastName': 'Goh', 'Affiliation': 'Department of Physical Education and Human Performance, Central Connecticut State University, 1615 Stanley Street, New Britain, CT, 06050, USA.'}, {'ForeName': 'Chee Hoi', 'Initials': 'CH', 'LastName': 'Leong', 'Affiliation': 'Department of Physical Education and Human Performance, Central Connecticut State University, 1615 Stanley Street, New Britain, CT, 06050, USA.'}, {'ForeName': 'Marybeth', 'Initials': 'M', 'LastName': 'Fede', 'Affiliation': 'Department of Health and Movement Sciences, Southern Connecticut State University, 501 Crescent Street, New Haven, CT, 06515, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Ciotto', 'Affiliation': 'School of Education and Professional Studies, Central Connecticut State University, 1615 Stanley Street, New Britain, CT, 06050, USA.'}]",The Journal of school health,['10.1111/josh.13167']
3445,35247214,Efficacy of plasma exchange therapy for diffuse alveolar hemorrhage in patients with microscopic polyangiitis.,"INTRODUCTION


Diffuse alveolar hemorrhage (DAH) is associated with high mortality. We examined the efficacy of plasma exchange (PE) therapy for reducing mortality in patients with patients with microscopic polyangiitis (MPA) and DAH.
METHODS


In this 52-week, non-randomized, open-label, one-arm, historical control, double-center controlled trial, four patients with MPA and DAH admitted to Juntendo University Hospital or Juntendo Koto Geriatric Medical Center between 2018 and 2021 were enrolled. Sixteen patients with MPA and DAH admitted to the two centers between 1998 and 2018 who did not receive PE were included as the historical control group. The primary outcome was the 52-weekurvival rate of patients in each treatment arm.
RESULTS


The 52-week survival rate of patients in the PE group (n=4) was higher than that of the historical control group (n=16) (100% vs. 13%, P=.04).
CONCLUSION


We found that PE may be efficacious for reducing mortality in patients with MPA and DAH. This article is protected by copyright. All rights reserved.",2022,"The 52-week survival rate of patients in the PE group (n=4) was higher than that of the historical control group (n=16) (100% vs. 13%, P=.04).
","['patients with patients with microscopic polyangiitis (MPA) and DAH', 'patients with MPA and DAH admitted to Juntendo University Hospital or Juntendo Koto Geriatric Medical Center between 2018 and 2021 were enrolled', 'Sixteen patients with MPA and DAH admitted to the two centers between 1998 and 2018 who did not receive PE were included as the historical control group', 'patients with MPA and DAH', 'patients with microscopic polyangiitis']","['plasma exchange (PE) therapy', 'PE', 'plasma exchange therapy']","['52-weekurvival rate', '52-week survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2347126', 'cui_str': 'Microscopic polyarteritis nodosa'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",4.0,0.182568,"The 52-week survival rate of patients in the PE group (n=4) was higher than that of the historical control group (n=16) (100% vs. 13%, P=.04).
","[{'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Abe', 'Affiliation': 'Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Makio', 'Initials': 'M', 'LastName': 'Kusaoi', 'Affiliation': 'Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kurisu', 'Initials': 'K', 'LastName': 'Tada', 'Affiliation': 'Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Yamaji', 'Affiliation': 'Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Tamura', 'Affiliation': 'Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo, Japan.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.13824']
3446,35247743,The priorities of people with mesothelioma and their carers: A qualitative interview study of trial participation and treatment decisions.,"PURPOSE


Treatment options for mesothelioma are increasing, as are the number of clinical trials available to patients. However, little is known about patients' and relatives' priorities when making decisions about treatment and trial participation. The aim of this study was to provide insight into people's experiences of participating in clinical research and explore the factors influencing decision-making.
METHODS


Face to face, semi-structured interviews were undertaken with mesothelioma patients who were participating in the TILT trial (a randomised trial of intra-pleural immunotherapy) and their relatives. Interviews were audio-recorded, transcribed and analysed thematically.
RESULTS


Twelve people were interviewed, comprising five mesothelioma patients and seven relatives. Four themes were identified relating to the experience of mesothelioma: physicality, quality of life, uncertainty and risk, and planning for an unpredictable future. A further theme related to attitudes to research participation.
PARTICIPANTS


valued physical strength and were careful not to jeopardise this with potential side effects of medication. Quality of life was important and was often prioritised over survival. Participants found ambiguity challenging and sought certainty, potentially in response to the uncertainty surrounding their future. The desire for certainty impacted on risk perception; an important factor in decision-making. Relatives often advocated on behalf of patients and were more reluctant about research participation due to concern about potential risks.
CONCLUSION


The study confirmed previous qualitative findings around physicality, stoicism and uncertainty, building on these themes to highlight their influence on decision-making. Important findings for practice include the challenges associated with risk communication and the differing care needs and attitudes to research of relatives.",2022,"Four themes were identified relating to the experience of mesothelioma: physicality, quality of life, uncertainty and risk, and planning for an unpredictable future.","['Face to face, semi-structured interviews were undertaken with mesothelioma patients who were participating in the TILT trial (a randomised trial of intra-pleural immunotherapy) and their relatives', 'people with mesothelioma and their carers', 'Twelve people were interviewed, comprising five mesothelioma patients and seven relatives']",[],['Quality of life'],"[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0025500', 'cui_str': 'Mesothelioma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205453', 'cui_str': '7'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",12.0,0.0470314,"Four themes were identified relating to the experience of mesothelioma: physicality, quality of life, uncertainty and risk, and planning for an unpredictable future.","[{'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Bibby', 'Affiliation': 'North Bristol Lung Centre, North Bristol NHS Trust, Bristol, UK. Electronic address: Anna.Bibby@bristol.ac.uk.'}, {'ForeName': 'Anna J', 'Initials': 'AJ', 'LastName': 'Morley', 'Affiliation': 'North Bristol Lung Centre, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Keenan', 'Affiliation': 'North Bristol Lung Centre, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, University of Bristol Medical School, Bristol, UK; North Bristol Lung Centre, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Gooberman-Hill', 'Affiliation': 'NIHR Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK; University of Bristol Medical School, Bristol, UK.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2022.102111']
3447,35247729,Neurofeedback-guided kinesthetic motor imagery training in Parkinson's disease: Randomized trial.,"BACKGROUND


Parkinson's disease (PD) causes difficulty with maintaining the speed, size, and vigor of movements, especially when they are internally generated. We previously proposed that the insula is important in motivating intentional movement via its connections with the dorsomedial frontal cortex (dmFC). We demonstrated that subjects with PD can increase the right insula-dmFC functional connectivity using fMRI-based neurofeedback (NF) combined with kinesthetic motor imagery (MI). The current study is a randomized clinical trial testing whether NF-guided kinesthetic MI training can improve motor performance and increase task-based and resting-state right insula-dmFC functional connectivity in subjects with PD.
METHODS


We assigned nondemented subjects with mild PD (Hoehn & Yahr stage ≤ 3) to the experimental kinesthetic MI with NF (MI-NF, n = 22) and active control visual imagery (VI, n = 22) groups. Only the MI-NF group received NF-guided MI training (10-12 runs). The NF signal was based on the right insula-dmFC functional connectivity strength. All subjects also practiced their respective imagery tasks at home daily for 4 weeks. Post-training changes in 1) task-based and resting-state right insula-dmFC functional connectivity were the primary imaging outcomes, and 2) MDS-UPDRS motor exam and motor function scores were the primary and secondary clinical outcomes, respectively.
RESULTS


The MI-NF group was not significantly different from the VI group in any of the primary imaging or clinical outcome measures. The MI-NF group reported subjective improvement in kinesthetic body awareness. There was significant and comparable improvement only in motor function scores in both groups (secondary clinical outcome). This improvement correlated with NF regulation of the right insula-dmFC functional connectivity only in the MI-NF group. Both groups showed specific training effects in whole-brain functional connectivity with distinct neural circuits supporting kinesthetic motor and visual imagery (exploratory imaging outcome).
CONCLUSIONS


The functional connectivity-based NF regulation was unsuccessful, however, both kinesthetic MI and VI practice improved motor function in our cohort with mild PD.",2022,"Both groups showed specific training effects in whole-brain functional connectivity with distinct neural circuits supporting kinesthetic motor and visual imagery (exploratory imaging outcome).
","['subjects with PD', ""Parkinson's disease"", 'nondemented subjects with mild PD (Hoehn & Yahr stage\xa0≤\xa03) to the']","['NF-guided MI training', 'NF-guided kinesthetic MI training', 'experimental kinesthetic MI with NF (MI-NF, n\xa0=\xa022) and active control visual imagery', 'fMRI-based neurofeedback (NF) combined with kinesthetic motor imagery (MI', 'Neurofeedback-guided kinesthetic motor imagery training']","['NF regulation of the right insula-dmFC functional connectivity', 'MDS-UPDRS motor exam and motor function scores', 'motor function scores', 'motor performance and increase task-based and resting-state right insula-dmFC functional connectivity', 'kinesthetic body awareness', 'right insula-dmFC functional connectivity']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",22.0,0.113779,"Both groups showed specific training effects in whole-brain functional connectivity with distinct neural circuits supporting kinesthetic motor and visual imagery (exploratory imaging outcome).
","[{'ForeName': 'Sule', 'Initials': 'S', 'LastName': 'Tinaz', 'Affiliation': 'Yale School of Medicine, Department of Neurology, Division of Movement Disorders, 15 York St, LCI 710, New Haven, CT 06510, USA; Yale School of Medicine, Clinical Neuroscience Imaging Center, 789 Howard Ave, New Haven, CT 06519, USA. Electronic address: sule.tinaz@yale.edu.'}, {'ForeName': 'Serageldin', 'Initials': 'S', 'LastName': 'Kamel', 'Affiliation': 'Yale School of Medicine, Department of Neurology, Division of Movement Disorders, 15 York St, LCI 710, New Haven, CT 06510, USA; Yale School of Medicine, Clinical Neuroscience Imaging Center, 789 Howard Ave, New Haven, CT 06519, USA.'}, {'ForeName': 'Sai S', 'Initials': 'SS', 'LastName': 'Aravala', 'Affiliation': 'Yale School of Medicine, Department of Neurology, Division of Movement Disorders, 15 York St, LCI 710, New Haven, CT 06510, USA; Yale School of Medicine, Clinical Neuroscience Imaging Center, 789 Howard Ave, New Haven, CT 06519, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elfil', 'Affiliation': 'Yale School of Medicine, Department of Neurology, Division of Movement Disorders, 15 York St, LCI 710, New Haven, CT 06510, USA; Yale School of Medicine, Clinical Neuroscience Imaging Center, 789 Howard Ave, New Haven, CT 06519, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Bayoumi', 'Affiliation': 'Yale School of Medicine, Department of Neurology, Division of Movement Disorders, 15 York St, LCI 710, New Haven, CT 06510, USA; Yale School of Medicine, Clinical Neuroscience Imaging Center, 789 Howard Ave, New Haven, CT 06519, USA.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Yale School of Medicine, Department of Neurology, Division of Movement Disorders, 15 York St, LCI 710, New Haven, CT 06510, USA.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Scheinost', 'Affiliation': 'Yale School of Medicine, Department of Radiology and Biomedical Imaging, 300 Cedar St, New Haven, CT 06519, USA; Yale University, Department of Biomedical Engineering, 17 Hillhouse Avenue, New Haven, CT 06520, USA; Yale School of Medicine, Child Study Center, 230 South Frontage Road, New Haven, CT 06519, USA.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Yale School of Medicine, Yale Stress Center, 2 Church St South, Suite 209, New Haven, CT 06519, USA; Yale School of Medicine, Department of Psychiatry, 300 George St, New Haven, CT 06511, USA; Yale School of Medicine, Department of Neuroscience, 333 Cedar St, SHM-L-200, New Haven, CT 06510, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hampson', 'Affiliation': 'Yale School of Medicine, Department of Radiology and Biomedical Imaging, 300 Cedar St, New Haven, CT 06519, USA; Yale University, Department of Biomedical Engineering, 17 Hillhouse Avenue, New Haven, CT 06520, USA; Yale School of Medicine, Child Study Center, 230 South Frontage Road, New Haven, CT 06519, USA; Yale School of Medicine, Department of Psychiatry, 300 George St, New Haven, CT 06511, USA.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2022.102980']
3448,35247922,Prognostic and predictive factors in patients with advanced HCC and elevated alpha-fetoprotein treated with ramucirumab in two randomized Phase III trial.,"PURPOSE


Ramucirumab is an effective treatment for patients with advanced HCC (aHCC) and baseline AFP {greater than or equal to}400 ng/mL. We aimed to identify prognostic and predictive factors of response to ramucirumab in patients with aHCC with AFP {greater than or equal to}400 ng/mL from the Phase III REACH and REACH-2 randomized trials.
EXPERIMENTAL DESIGN


Patients with aHCC, Child-Pugh class A with prior sorafenib treatment were randomized in REACH and REACH-2 (ramucirumab 8 mg/kg or placebo, biweekly). Meta-analysis of individual patient-level data (pooled population) from REACH (AFP {greater than or equal to}400 ng/mL) and REACH-2 was performed. A drug exposure analysis was conducted for those with evaluable pharmacokinetics data. To identify potential prognostic factors for overall survival (OS), multivariate analyzes were performed using a Cox proportional hazard regression model. To define predictors of ramucirumab benefit, subgroup-by-treatment interactions terms were evaluated.
RESULTS


Of 542 patients (316 ramucirumab, 226 placebo) analyzed, 8 variables had independent prognostic value associated with poor outcome (geographical region, ECOG PS {greater than or equal to}1, AFP &gt;1000 ng/mL, Child-Pugh &gt;A5, extrahepatic spread, high neutrophil-to-lymphocyte, high alkaline phosphatase and aspartate aminotransferase). Ramucirumab benefit was present across all subgroups, including patients with very aggressive HCC (above median AFP; HR: 0.64; 95%CI:0.49-0.84) and non-viral aHCC (HR: 0.56; 95%CI:0.40-0.79). While no baseline factor was predictive of a differential OS benefit with ramucirumab, analyzes demonstrated an association between high drug exposure, treatment-emergent hypertension (Grade {greater than or equal to}3) and increased ramucirumab benefit.
CONCLUSIONS


Ramucirumab provided a survival benefit irrespective of baseline prognostic covariates, and this benefit was greatest in patients with high ramucirumab drug exposure and/or those with treatment-related hypertension.",2022,"Ramucirumab benefit was present across all subgroups, including patients with very aggressive HCC (above median AFP; HR: 0.64; 95%CI:0.49-0.84) and non-viral aHCC (HR: 0.56; 95%CI:0.40-0.79).","['542 patients (316 ramucirumab, 226 placebo) analyzed', 'patients with advanced HCC (aHCC) and baseline AFP {greater than or equal to}400 ng/mL', 'patients with aHCC with AFP {greater than or equal to}400 ng/mL from the Phase III REACH and REACH-2 randomized trials', 'Patients with aHCC, Child-Pugh class A with prior sorafenib treatment were randomized in', 'patients with high ramucirumab drug exposure and/or those with treatment-related hypertension', 'patients with advanced HCC and elevated alpha-fetoprotein treated with']","['ramucirumab', 'REACH and REACH-2 (ramucirumab 8 mg/kg or placebo']","['Child-Pugh &gt;A5, extrahepatic spread, high neutrophil-to-lymphocyte, high alkaline phosphatase and aspartate aminotransferase', 'poor outcome (geographical region, ECOG PS ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0201539', 'cui_str': 'Alpha-1-Fetoprotein measurement'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0235971', 'cui_str': 'Alpha 1 foetoprotein increased'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}]",542.0,0.129539,"Ramucirumab benefit was present across all subgroups, including patients with very aggressive HCC (above median AFP; HR: 0.64; 95%CI:0.49-0.84) and non-viral aHCC (HR: 0.56; 95%CI:0.40-0.79).","[{'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Llovet', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, United States.'}, {'ForeName': 'Amit G', 'Initials': 'AG', 'LastName': 'Singal', 'Affiliation': 'The University of Texas Southwestern Medical Center, Dallas, United States.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Villanueva', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'UCLA Medical Center, Santa Monica, CA, United States.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': 'Universitätsmedizin Mainz, Mainz, Germany.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa Chiba, Japan.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Callies', 'Affiliation': 'Eli Lilly and Company, Neuilly-sur-Seine Cedex, France.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'McGrath', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States.'}, {'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly and Company, Indiana, United States.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Abada', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Widau', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gonzalez-Gugel', 'Affiliation': 'Eli Lilly and Company, Indiana, United States.'}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'I-Mab Biopharma, Shanghai, China.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-4000']
3449,34998804,The mediating role of emotion regulation in transdiagnostic cognitive behavioural therapy for emotional disorders in primary care: Secondary analyses of the PsicAP randomized controlled trial.,"BACKGROUND


Emotional disorders are highly prevalent in primary care. Transdiagnostic cognitive behavior therapy (TD-CBT) is a promising treatment of emotional disorders. In this study, we evaluated several emotion regulation strategies as potential mediators of treatment outcomes in a clinical sample of primary care.
METHODS


A total of 1061 primary care patients were included in a randomized clinical trial comparing treatment-as-usual (TAU) to TD-CBT+TAU. Of these, 631 (TAU=316; TD-CBT+TAU=315) completed the full treatment and all pre- and post-treatment scales to assess symptoms (anxiety, depression, somatization), emotion regulation strategies (worry, rumination, negative metacognition, suppression, cognitive reappraisal), overall functioning, and quality of life (QoL).
RESULTS


Treatment and direct effects showed that TD-CBT+TAU was superior to TAU alone. On the multivariate mediation analysis of indirect effects, three maladaptive strategies (worry, rumination and negative metacognition) had significant effects on all emotional symptoms. Suppression was also significant for depression. Rumination and negative metacognition were significant mediators of functioning, while only negative metacognition was significant for QoL. Reappraisal had no effect on any outcome.
LIMITATIONS


We focused mainly on maladaptive cognitive emotion regulation strategies and only studied one behavioural strategy (suppression) and one adaptive strategy (reappraisal).
CONCLUSIONS


Targeting certain maladaptive emotion regulation strategies (worry, rumination, suppression, negative metacognition) as mediators for treatment with TD-CBT could reduce emotional symptoms and improve well-being. Negative metacognition was the most transdiagnostic strategy, whereas an adaptive strategy such as reappraisal was not a mediator. Thus, maladaptive emotion regulation strategies are key mediators in transdiagnostic therapy for emotional disorders in primary care.",2022,"Rumination and negative metacognition were the only significant mediators of functioning, while only negative metacognition was significant for QoL. Reappraisal had no effect on any outcome.
","['1061 primary care patients', 'emotional disorders in primary care']","['Transdiagnostic cognitive behaviour therapy (TD-CBT', 'maladaptive cognitive emotion regulation strategies and only studied one behavioural strategy (suppression) and one adaptive strategy (reappraisal', 'transdiagnostic cognitive behavioural therapy']","['symptoms (anxiety, depression, somatization), emotion regulation strategies (worry, rumination, negative metacognition, suppression, cognitive reappraisal), overall functioning, and quality of life (QoL', 'emotional symptoms', 'Rumination and negative metacognition']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",1061.0,0.063889,"Rumination and negative metacognition were the only significant mediators of functioning, while only negative metacognition was significant for QoL. Reappraisal had no effect on any outcome.
","[{'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Muñoz-Navarro', 'Affiliation': 'Department of Personality, Assessment and Psychological Treatments Faculty of Psychology. University of Valencia, Av. Blasco Ibáñez, 10. 46010. Valencia, Spain. Electronic address: roger.munoz@uv.es.'}, {'ForeName': 'Leonardo Adrián', 'Initials': 'LA', 'LastName': 'Medrano', 'Affiliation': 'Department of Psychology, Pontificia Universidad Católica Madre y Maestra, Autopista Duarte Km 1 1/2, Santiago De Los Caballeros 51000, Dominican Republic. Electronic address: Leonardo.Medrano@ues21.edu.ar.'}, {'ForeName': 'Joaquín T', 'Initials': 'JT', 'LastName': 'Limonero', 'Affiliation': 'Department of Basic Psychology, University Autonoma of Barcelona, Plaça Cívica, 08193 Bellaterra, Barcelona, Spain. Electronic address: joaquin.limonero@uab.cat.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'González-Blanch', 'Affiliation': 'Mental Health Centre, University Hospital ""Marqués de Valdecilla""- IDIVAL. Av. Valdecilla, 25, 39008 Santander, Cantabria, Spain. Electronic address: cesar.gonzalezblanch@scsalud.es.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Moriana', 'Affiliation': 'Department of Psychology, University of Córdoba/ Maimónides Institute for Research in Biomedicine of Cordoba-IMIBIC/Reina Sofía University Hospital. Av. Menéndez Pidal, s/n, 14004 Córdoba, Spain. Electronic address: jamoriana@uco.es.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Ruiz-Rodríguez', 'Affiliation': 'Castilla La Nueva Primary Care Centre, Health Service of Madrid. Calle Teruel, 4, 28941 Fuenlabrada, Madrid, Spain. Electronic address: pruizr@salud.madrid.org.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cano-Vindel', 'Affiliation': 'Department of Experimental Psychology. Faculty of Psychology, Complutense University of Madrid, Campus de Somosaguas, s/n, 28223 Madrid, Spain. Electronic address: canovindel@psi.ucm.es.'}]",Journal of affective disorders,['10.1016/j.jad.2022.01.029']
3450,34998508,"Pharmacokinetics of tranexamic acid after intravenous, intramuscular, and oral routes: a prospective, randomised, crossover trial in healthy volunteers.","BACKGROUND


In response to the World Health Organization call for research on alternative routes for tranexamic acid (TXA) administration in women with postpartum haemorrhage, we examined the pharmacokinetics of TXA after i.v., i.m., or oral administration.
METHODS


We conducted a randomised, open-label, crossover trial in 15 healthy volunteers who received i.v. TXA 1 g, i.m. TXA 1 g, or oral TXA solution 2 g. Blood samples were drawn up to 24 h after administration. Tranexamic acid concentration was measured with liquid chromatography-mass spectrometry, and the parameters of the pharmacokinetic models were estimated using population pharmacokinetics.
RESULTS


The median time to reach a concentration of 10 mg L -1  was 3.5 min for the i.m. route and 66 min for the oral route, although with the oral route the target concentration was reached in only 11 patients. Median peak concentrations were 57.5, 34.4, and 12.8 mg L -1  for i.v., i.m., and oral routes, respectively. A two-compartment open model with body weight as the main covariate best fitted the data. For a 70 kg volunteer, the population estimates were 10.1 L h -1  for elimination clearance, 15.6 L h -1  for intercompartmental clearance, 7.7 L for the volume of central compartment, and 10.8 L for the volume of the peripheral compartment. Intramuscular and oral bioavailabilities were 1.0 and 0.47, respectively, showing that i.m. absorption is fast and complete. Adverse events were mild and transient, mainly local reactions and low-intensity pain.
CONCLUSIONS


The i.m. (but not oral) route appears to be an efficient alternative to i.v. tranexamic acid. Studies in pregnant women are needed to examine the impact of pregnancy on the pharmacokinetics.
CLINICAL TRIAL REGISTRATION


EudraCT 2019-000285-38; NCT03777488.",2022,The median time to reach a concentration of 10 mg L -1  was 3.5 min for the i.m.,"['women with postpartum haemorrhage', 'pregnant women', 'healthy volunteers', '15 healthy volunteers who received i.v']","['EudraCT', 'tranexamic acid', 'tranexamic acid (TXA', 'TXA']","['local reactions and low-intensity pain', 'median time to reach a concentration', 'Median peak concentrations', 'Intramuscular and oral bioavailabilities', 'Tranexamic acid concentration']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]",15.0,0.0453991,The median time to reach a concentration of 10 mg L -1  was 3.5 min for the i.m.,"[{'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Grassin-Delyle', 'Affiliation': 'Infection et inflammation, Département de Biotechnologie de la Santé, Université Paris-Saclay, University of Versailles Saint-Quentin-en-Yvelines, INSERM, Montigny le Bretonneux, France; Département des maladies des voies respiratoires, Hôpital Foch, Suresnes, France. Electronic address: stanislas.grassin-delyle@uvsq.fr.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Semeraro', 'Affiliation': ""Centre d'Investigation Clinique P1419, INSERM, Hôpital Cochin-Necker, Université de Paris, Paris, France.""}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lamy', 'Affiliation': 'Infection et inflammation, Département de Biotechnologie de la Santé, Université Paris-Saclay, University of Versailles Saint-Quentin-en-Yvelines, INSERM, Montigny le Bretonneux, France.'}, {'ForeName': 'Saïk', 'Initials': 'S', 'LastName': 'Urien', 'Affiliation': 'Unité de Recherche Clinique, Hôpital Cochin-Necker, Université de Paris, Paris, France.'}, {'ForeName': 'Iléana', 'Initials': 'I', 'LastName': 'Runge', 'Affiliation': 'Infection et inflammation, Département de Biotechnologie de la Santé, Université Paris-Saclay, University of Versailles Saint-Quentin-en-Yvelines, INSERM, Montigny le Bretonneux, France.'}, {'ForeName': 'Frantz', 'Initials': 'F', 'LastName': 'Foissac', 'Affiliation': 'Unité de Recherche Clinique, Hôpital Cochin-Necker, Université de Paris, Paris, France.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Bouazza', 'Affiliation': 'Unité de Recherche Clinique, Hôpital Cochin-Necker, Université de Paris, Paris, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Treluyer', 'Affiliation': ""Centre d'Investigation Clinique P1419, INSERM, Hôpital Cochin-Necker, Université de Paris, Paris, France; Unité de Recherche Clinique, Hôpital Cochin-Necker, Université de Paris, Paris, France.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Arribas', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Haleema', 'Initials': 'H', 'LastName': 'Shakur-Still', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}]",British journal of anaesthesia,['10.1016/j.bja.2021.10.054']
3451,34999737,Identification of ∆9-tetrahydrocannabinol (THC) impairment using functional brain imaging.,"The primary cannabinoid in cannabis, Δ9-tetrahydrocannabinol (THC), causes intoxication and impaired function, with implications for traffic, workplace, and other situational safety risks. There are currently no evidence-based methods to detect cannabis-impaired driving, and current field sobriety tests with gold-standard, drug recognition evaluations are resource-intensive and may be prone to bias. This study evaluated the capability of a simple, portable imaging method to accurately detect individuals with THC impairment. In this double-blind, randomized, cross-over study, 169 cannabis users, aged 18-55 years, underwent functional near-infrared spectroscopy (fNIRS) before and after receiving oral THC and placebo, at study visits one week apart. Impairment was defined by convergent classification by consensus clinical ratings and an algorithm based on post-dose tachycardia and self-rated ""high."" Our primary outcome, prefrontal cortex (PFC) oxygenated hemoglobin concentration (HbO), was increased after THC only in participants operationalized as impaired, independent of THC dose. ML models using fNIRS time course features and connectivity matrices identified impairment with 76.4% accuracy, 69.8% positive predictive value (PPV), and 10% false-positive rate using convergent classification as ground truth, which exceeded Drug Recognition Evaluator-conducted expanded field sobriety examination (67.8% accuracy, 35.4% PPV, and 35.4% false-positive rate). These findings demonstrate that PFC response activation patterns and connectivity produce a neural signature of impairment, and that PFC signal, measured with fNIRS, can be used as a sole input to ML models to objectively determine impairment from THC intoxication at the individual level. Future work is warranted to determine the specificity of this classifier to acute THC impairment.ClinicalTrials.gov Identifier: NCT03655717.",2022,"ML models using fNIRS time course features and connectivity matrices identified impairment with 76.4% accuracy, 69.8% positive predictive value (PPV), and 10% false-positive rate using convergent classification as ground truth, which exceeded Drug Recognition Evaluator-conducted expanded field sobriety examination (67.8% accuracy, 35.4% PPV, and 35.4% false-positive rate).","['individuals with THC impairment', '169 cannabis users, aged 18-55 years, underwent functional near-infrared spectroscopy (fNIRS) before and after receiving']","['oral THC and placebo', '∆9-tetrahydrocannabinol (THC']","['PFC oxygenated hemoglobin concentration (HbO', 'cannabis, Δ9-tetrahydrocannabinol (THC), causes intoxication and impaired function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",169.0,0.144171,"ML models using fNIRS time course features and connectivity matrices identified impairment with 76.4% accuracy, 69.8% positive predictive value (PPV), and 10% false-positive rate using convergent classification as ground truth, which exceeded Drug Recognition Evaluator-conducted expanded field sobriety examination (67.8% accuracy, 35.4% PPV, and 35.4% false-positive rate).","[{'ForeName': 'Jodi M', 'Initials': 'JM', 'LastName': 'Gilman', 'Affiliation': 'Massachusetts General Hospital (MGH) Department of Psychiatry, Boston, MA, USA. jgilman1@mgh.harvard.edu.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Schmitt', 'Affiliation': 'Massachusetts General Hospital (MGH) Department of Psychiatry, Boston, MA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Potter', 'Affiliation': 'Massachusetts General Hospital (MGH) Department of Psychiatry, Boston, MA, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kendzior', 'Affiliation': ''}, {'ForeName': 'Gladys N', 'Initials': 'GN', 'LastName': 'Pachas', 'Affiliation': 'Massachusetts General Hospital (MGH) Department of Psychiatry, Boston, MA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hickey', 'Affiliation': 'Massachusetts General Hospital (MGH) Department of Psychiatry, Boston, MA, USA.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Makary', 'Affiliation': 'MGH/HST Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Marilyn A', 'Initials': 'MA', 'LastName': 'Huestis', 'Affiliation': 'Institute of Emerging Health Professions, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Massachusetts General Hospital (MGH) Department of Psychiatry, Boston, MA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-021-01259-0']
3452,35005804,"Can we say that detrusor contractility did not change in: ""Evaluation of the effect of 100 U of Onabotulinum toxin A on detrusor contractility in women with idiopathic OAB: A multicentre prospective study. De Rienzo G, Minafra P, Iliano E et al. Neurourol Urodyn. 2021 Oct 19. doi: 10.1002/nau.24820"".",,2022,,"['2021', 'women with idiopathic OAB']",['Onabotulinum toxin A'],['detrusor contractility'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}]","[{'cui': 'C4743433', 'cui_str': 'onabotulinum toxin A'}]",[],,0.0321915,,"[{'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Valdevenito', 'Affiliation': 'Department of Urology, Hospital Clínico Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Mercado-Campero', 'Affiliation': 'Department of Urology, Hospital Clínico Universidad de Chile, Santiago, Chile.'}]",Neurourology and urodynamics,['10.1002/nau.24865']
3453,35000098,"Paltusotine, a novel oral once-daily nonpeptide SST2 receptor agonist, suppresses GH and IGF-1 in healthy volunteers.","PURPOSE


Evaluate the pharmacodynamics, pharmacokinetics, and safety of paltusotine, an orally bioavailable, nonpeptide, somatostatin receptor subtype 2 (SST2) agonist being developed for the treatment of acromegaly and neuroendocrine tumors.
METHODS


A randomized, double-blind, placebo-controlled, single center, single and multiple ascending dose phase 1 study was conducted in healthy male volunteers who received (i) single-dose of oral paltusotine 1.25, 2.5, 5, 10, and 20 mg (solution); and 40 and 60 mg (capsules) or (ii) multiple-dose oral paltusotine capsules once daily 5 mg (× 7 days), 10, 20, and 30 mg (× 10 days). Main outcome measures were pharmacodynamics (changes in growth hormone-releasing hormone [GHRH] stimulated growth hormone [GH] and insulin-like growth factor 1 [IGF-1]), pharmacokinetics, safety, and tolerability.
RESULTS


Single-dose cohorts: n = 41 active, n = 14 placebo. Multiple-dose cohorts: n = 24 active, n = 12 placebo. Paltusotine was well tolerated, orally bioavailable, associated with increased plasma concentrations to doses up to 40 mg, and was eliminated with a half-life of approximately 30 h. Single-dose paltusotine 1.25 to 20 mg suppressed GHRH-stimulated GH secretion by 44% to 93% compared to 15% with placebo. Multiple-dose paltusotine 5 to 30 mg administered once daily for 10 days suppressed IGF-1 by 19% to 37% compared to an increase of 2.4% with placebo.
CONCLUSIONS


Paltusotine suppresses GH and IGF-1 in a dose-dependent fashion, with a safety profile similar to currently approved SST2 receptor ligands. Paltusotine is a promising once-daily oral nonpeptide SST2 agonist candidate for managing acromegaly and neuroendocrine tumors.
TRIAL REGISTRATION


NCT03276858, registered September 8, 2017, retrospectively registered.",2022,"Paltusotine was well tolerated, orally bioavailable, associated with increased plasma concentrations to doses up to 40 mg, and was eliminated with a half-life of approximately 30 h. Single-dose paltusotine 1.25 to 20 mg suppressed GHRH-stimulated GH secretion by 44% to 93% compared to 15% with placebo.","['healthy male volunteers who received (i) single-dose of', 'healthy volunteers']","['placebo', 'oral paltusotine 1.25, 2.5, 5, 10, and 20\xa0mg (solution); and 40 and 60\xa0mg (capsules) or (ii) multiple-dose oral paltusotine capsules', 'Paltusotine']","['tolerated, orally bioavailable', 'plasma concentrations', 'IGF-1', 'GHRH-stimulated GH secretion', 'pharmacodynamics (changes in growth hormone-releasing hormone [GHRH] stimulated growth hormone [GH] and insulin-like growth factor 1 [IGF-1]), pharmacokinetics, safety, and tolerability']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.472755,"Paltusotine was well tolerated, orally bioavailable, associated with increased plasma concentrations to doses up to 40 mg, and was eliminated with a half-life of approximately 30 h. Single-dose paltusotine 1.25 to 20 mg suppressed GHRH-stimulated GH secretion by 44% to 93% compared to 15% with placebo.","[{'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Madan', 'Affiliation': 'Crinetics Pharmaceuticals, Inc, 10222 Barnes Canyon Road, Building 2, San Diego, CA, 92121, USA. amadan@crinetics.com.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Markison', 'Affiliation': 'Crinetics Pharmaceuticals, Inc, 10222 Barnes Canyon Road, Building 2, San Diego, CA, 92121, USA.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Betz', 'Affiliation': 'Crinetics Pharmaceuticals, Inc, 10222 Barnes Canyon Road, Building 2, San Diego, CA, 92121, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Krasner', 'Affiliation': 'Crinetics Pharmaceuticals, Inc, 10222 Barnes Canyon Road, Building 2, San Diego, CA, 92121, USA.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Luo', 'Affiliation': 'Crinetics Pharmaceuticals, Inc, 10222 Barnes Canyon Road, Building 2, San Diego, CA, 92121, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Jochelson', 'Affiliation': 'Crinetics Pharmaceuticals, Inc, 10222 Barnes Canyon Road, Building 2, San Diego, CA, 92121, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Struthers', 'Affiliation': 'Crinetics Pharmaceuticals, Inc, 10222 Barnes Canyon Road, Building 2, San Diego, CA, 92121, USA.'}]",Pituitary,['10.1007/s11102-021-01201-z']
3454,35000068,Efficacy and safety of ferric derisomaltose (FDI) compared with iron sucrose (IS) in patients with iron deficiency anemia after bariatric surgery.,"PURPOSE


Iron deficiency is common following bariatric surgery, and treatment with intravenous iron is often required. This post hoc analysis of data from two randomized, open-label, multicenter trials evaluated the efficacy and safety of ferric derisomaltose (FDI; formerly iron isomaltoside 1000) versus iron sucrose (IS) over 4 weeks in adults with iron deficiency anemia (IDA) resulting from prior bariatric surgery.
MATERIALS AND METHODS


Data were pooled for participants who received FDI or IS in the PROVIDE or FERWON-IDA trials for the treatment of IDA post bariatric surgery. Efficacy outcomes included changes in hemoglobin (Hb) and iron parameters; safety outcomes included the incidence of adverse drug reactions (ADRs), serious or severe hypersensitivity reactions (HSRs), and hypophosphatemia.
RESULTS


The analysis included 159 patients. Mean (standard deviation) cumulative iron doses were 1199 (± 347) mg for FDI and 937 (± 209) mg for IS. Compared with IS, FDI resulted in a faster and more pronounced Hb response, and a higher proportion of responders (Hb level increase ≥ 2 g/dL from baseline) at all time points. The incidence of ADRs was similar with FDI and IS (15.1% and 18.2%, respectively), with no serious ADRs or serious or severe HSRs reported. The incidence of hypophosphatemia was low and similar in both treatment groups, with no cases of severe hypophosphatemia observed.
CONCLUSIONS


In patients with IDA resulting from bariatric surgery, FDI produced a faster and more pronounced Hb response than IS. Both FDI and IS were well tolerated.",2022,"The incidence of hypophosphatemia was low and similar in both treatment groups, with no cases of severe hypophosphatemia observed.
","['adults with iron deficiency anemia (IDA) resulting from prior bariatric surgery', 'patients with iron deficiency anemia after bariatric surgery', '159 patients', 'Data were pooled for participants who received FDI or IS in the PROVIDE or FERWON-IDA trials for the treatment of IDA post bariatric surgery']","['iron sucrose (IS', 'ferric derisomaltose (FDI; formerly iron isomaltoside 1000) versus iron sucrose (IS', 'ferric derisomaltose (FDI']","['incidence of ADRs', 'tolerated', 'proportion of responders (Hb level increase\u2009≥', 'incidence of hypophosphatemia', 'changes in hemoglobin (Hb) and iron parameters; safety outcomes included the incidence of adverse drug reactions (ADRs), serious or severe hypersensitivity reactions (HSRs), and hypophosphatemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0060241', 'cui_str': 'iron sucrose'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0060241', 'cui_str': 'iron sucrose'}, {'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C2947549', 'cui_str': 'iron isomaltoside 1000'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0602865,"The incidence of hypophosphatemia was low and similar in both treatment groups, with no cases of severe hypophosphatemia observed.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Auerbach', 'Affiliation': 'Department of Medicine, Georgetown University School of Medicine, Washington, DC, USA. mauerbachmd@abhemonc.com.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Achebe', 'Affiliation': ""Brigham and Women's Hospital, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Thomsen', 'Affiliation': 'Department of Clinical and Non-Clinical Research, Pharmacosmos A/S, Holbæk, Denmark.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}]",Obesity surgery,['10.1007/s11695-021-05858-0']
3455,35015296,Immunoglobulin for multifocal motor neuropathy.,"BACKGROUND


Multifocal motor neuropathy (MMN) is a rare, probably immune-mediated disorder characterised by slowly progressive, asymmetric, distal weakness of one or more limbs with no objective loss of sensation. It may cause prolonged periods of disability. Treatment options for MMN are few. People with MMN do not usually respond to steroids or plasma exchange. Uncontrolled studies have suggested a beneficial effect of intravenous immunoglobulin (IVIg). This is an update of a Cochrane Review first published in 2005, with an amendment in 2007. We updated the review to incorporate new evidence.
OBJECTIVES


To assess the efficacy and safety of intravenous and subcutaneous immunoglobulin in people with MMN.
SEARCH METHODS


We searched the following databases on 20 April 2021: the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and WHO ICTRP for randomised controlled trials (RCTs) and quasi-RCTs, and checked the reference lists of included studies.
SELECTION CRITERIA


We considered RCTs and quasi-RCTs examining the effects of any dose of IVIg and subcutaneous immunoglobulin (SCIg) in people with definite or probable MMN for inclusion in the review. Eligible studies had to have measured at least one of the following outcomes: disability, muscle strength, or electrophysiological conduction block. We used studies that reported the frequency of adverse effects to assess safety.
DATA COLLECTION AND ANALYSIS


Two review authors independently reviewed the literature searches to identify potentially relevant trials, assessed risk of bias of included studies, and extracted data. We followed standard Cochrane methodology.
MAIN RESULTS


Six cross-over RCTs including a total of 90 participants were suitable for inclusion in the review. Five RCTs compared IVIg to placebo, and one compared IVIg to SCIg. Four of the trials comparing IVIg versus placebo involved IVIg-naive participants (induction treatment). In the other two trials, participants were known IVIg responders receiving maintencance IVIg at baseline and were then randomised to maintenance treatment with IVIg or placebo in one trial, and IVIg or SCIg in the other. Risk of bias was variable in the included studies, with three studies at high risk of bias in at least one risk of bias domain. IVIg versus placebo (induction treatment): three RCTs including IVIg-naive participants reported a disability measure. Disability improved in seven out of 18 (39%) participants after IVIg treatment and in two out of 18 (11%) participants after placebo (risk ratio (RR) 3.00, 95% confidence interval (CI) 0.89 to 10.12; 3 RCTs, 18 participants; low-certainty evidence). The proportion of participants with an improvement in disability at 12 months was not reported. Strength improved in 21 out of 27 (78%) IVIg-naive participants treated with IVIg and one out of 27 (4%) participants who received placebo (RR 11.00, 95% CI 2.86 to 42.25; 3 RCTs, 27 participants; low-certainty evidence). IVIg treatment may increase the proportion of people with resolution of at least one conduction block; however, the results were also consistent with no effect (RR 7.00, 95% CI 0.95 to 51.70; 4 RCTs, 28 participants; low-certainty evidence). IVIg versus placebo (maintenance treatment): a trial that included participants on maintenance IVIg treatment reported an increase in disability in 17 out of 42 (40%) people switching to placebo and seven out of 42 (17%) remaining on IVIg (RR 2.43, 95% CI 1.13 to 5.24; 1 RCT, 42 participants; moderate-certainty evidence) and a decrease in grip strength in 20 out of 42 (48%) participants after a switch to placebo treatment compared to four out of 42 (10%) remaining on IVIg (RR 0.20, 95% CI 0.07 to 0.54; 1 RCT, 42 participants; moderate-certainty evidence). Adverse events, IVIg versus placebo (induction or maintenance): four trials comparing IVIg and placebo reported adverse events, of which data from two studies could be meta-analysed. Transient side effects were reported in 71% of IVIg-treated participants versus 4.8% of placebo-treated participants in these studies. The pooled RR for the development of side effects was 10.33 (95% CI 2.15 to 49.77; 2 RCTs, 21 participants; very low-certainty evidence). There was only one serious side effect (pulmonary embolism) during IVIg treatment. IVIg versus SCIg (maintenance treatment): the trial that compared continuation of IVIg maintenance versus SCIg maintenance did not measure disability. The evidence was very uncertain for muscle strength (standardised mean difference 0.08, 95% CI -0.84 to 1.00; 1 RCT, 9 participants; very low-certainty evidence). The evidence was very uncertain for the number of people with side effects attributable to treatment (RR 0.50, 95% CI 0.18 to 1.40; 1 RCT, 9 participants; very low-certainty evidence).
AUTHORS' CONCLUSIONS


Low-certainty evidence from three small RCTs shows that IVIg may improve muscle strength in people with MMN, and low-certainty evidence indicates that it may improve disability; the estimate of the magnitude of improvement of disability has wide CIs and needs further studies to secure its significance. Based on moderate-certainty evidence, it is probable that most IVIg responders deteriorate in disability and muscle strength after IVIg withdrawal. SCIg might be an alternative treatment to IVIg, but the evidence is very uncertain. More research is needed to identify people in whom IVIg withdrawal is possible and to confirm efficacy of SCIg as an alternative maintenance treatment.",2022,"The evidence was very uncertain for muscle strength (standardised mean difference 0.08, 95% CI -0.84 to 1.00; 1 RCT, 9 participants; very low-certainty evidence).","['participants were known IVIg responders receiving maintencance IVIg at baseline', 'people with MMN', 'people with definite or probable MMN for inclusion in the review', 'in 17 out of 42 (40']","['placebo', 'IVIg maintenance versus SCIg maintenance', 'Immunoglobulin', 'IVIg or placebo', 'intravenous immunoglobulin (IVIg', 'intravenous and subcutaneous immunoglobulin', 'IVIg and subcutaneous immunoglobulin (SCIg']","['proportion of people with resolution of at least one conduction block', 'side effects', 'disability', 'grip strength', 'efficacy and safety', 'serious side effect (pulmonary embolism', 'Disability', 'Transient side effects', 'Strength', 'disability, muscle strength, or electrophysiological conduction block', 'adverse events', 'muscle strength']","[{'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0393847', 'cui_str': 'Motor neuropathy with multiple conduction block'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018794', 'cui_str': 'Heart block'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",90.0,0.715331,"The evidence was very uncertain for muscle strength (standardised mean difference 0.08, 95% CI -0.84 to 1.00; 1 RCT, 9 participants; very low-certainty evidence).","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Keddie', 'Affiliation': 'Faculty of Brain Sciences, Institute of Neurology, London, UK.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Eftimov', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'van den Berg', 'Affiliation': 'Department of Neurology, University Medical Center Utrecht, Brain Center Rudolf Magnus, Utrecht, Netherlands.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Brassington', 'Affiliation': 'Queen Square Centre for Neuromuscular Diseases, National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'de Haan', 'Affiliation': 'Clinical Research Unit, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Ivo N', 'Initials': 'IN', 'LastName': 'van Schaik', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004429.pub3']
3456,35006328,Preoperative Carbohydrate Drink Intake Increases Glycemic Variability in Patients with Type 2 Diabetes Mellitus in Total Joint Arthroplasty: A Prospective Randomized Trial.,"BACKGROUND


Preoperative carbohydrate treatment attenuates insulin resistance and improves metabolism to an anabolic state. Despite these benefits, impaired glycemic control and aspiration risk related to gastroparesis represent concerns for patients with diabetes undergoing surgery. This randomized controlled trial investigated the effects of oral carbohydrate therapy on perioperative glucose variability, metabolic responses, and gastric volume in diabetic patients undergoing elective total hip or knee arthroplasty.
METHODS


Fifty diabetic patients scheduled to undergo elective total knee or hip arthroplasty during August 2019-October 2020 were randomly assigned to a control or carbohydrate therapy (CHO) group. CHO group of patients received a 400-mL carbohydrate drink 2-3 h before anesthesia; control group of patients underwent overnight fasting from midnight, one night before surgery. Blood glucose levels were measured before intake of the carbohydrate drink, before spinal anesthesia, preoperatively, immediately postoperatively, and 1 h postoperatively. Insulin level and gastric volume were measured before spinal anesthesia.
RESULTS


The glucose variability of patients in the CHO group was significantly higher than that of those in the control group (16.5 vs. 10.1%, P = 0.008). Similarly, insulin resistance was higher in the CHO group than in the control group (8.5 vs. 2.7, P < 0.001). The gastric volume did not differ significantly between the groups (61.3 vs. 15.2 ml, P = 0.082).
CONCLUSIONS


Preoperative oral carbohydrate therapy increases glucose variability and insulin resistance in diabetic patients. Therefore, carbohydrate beverages should be cautiously administered to diabetic patients, considering metabolic and safety aspects. Trial registration number ClinicalTrials.gov (No. NCT04013594).",2022,"The gastric volume did not differ significantly between the groups (61.3 vs. 15.2 ml, P = 0.082).
","['diabetic patients', 'diabetic patients undergoing elective total hip or knee arthroplasty', 'Fifty diabetic patients scheduled to undergo elective total knee or hip arthroplasty during August 2019-October 2020', 'patients with diabetes undergoing surgery', 'Patients with Type 2 Diabetes Mellitus in Total Joint Arthroplasty']","['carbohydrate therapy', 'CHO', '400-mL carbohydrate drink', 'oral carbohydrate therapy', 'Preoperative Carbohydrate Drink Intake', 'control or carbohydrate therapy (CHO']","['glucose variability and insulin resistance', 'glucose variability', 'insulin resistance', 'gastric volume', 'Blood glucose levels', 'Insulin level and gastric volume', 'Glycemic Variability', 'perioperative glucose variability, metabolic responses, and gastric volume']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0556158', 'cui_str': 'Drink intake'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",50.0,0.0319371,"The gastric volume did not differ significantly between the groups (61.3 vs. 15.2 ml, P = 0.082).
","[{'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'So Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Byung Woo', 'Initials': 'BW', 'LastName': 'Cho', 'Affiliation': 'Department of Orthopedic Surgery, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Sungmin', 'Initials': 'S', 'LastName': 'Suh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea.'}, {'ForeName': 'Kwan Kyu', 'Initials': 'KK', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea. kkpark@yuhs.ac.'}, {'ForeName': 'Yong Seon', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea. yschoi@yuhs.ac.'}]",World journal of surgery,['10.1007/s00268-021-06437-1']
3457,35013991,Implicit learning of a response-contingent task.,"In previous research, relative response speed was revealed to have been used as a predictive cue to guide attention to a target location, in a phenomenon known as ""cueing by response."" In this study, we explored whether responses can implicitly induce the use of cognitive control, especially in selecting and implementing task-sets. Participants were trained to perform tasks corresponding to different task cues during the training phase. Unbeknownst to participants, the response-contingent group's response to the previous trial determined task type in the subsequent trial, while that of the random group was randomly determined. When the task cue was removed in the testing phase, the percentage of correctly selected response-contingent tasks of the response-contingent group was at a greater level than the chance and the random group, implying that cueing by response can activate appropriate task-sets. The perceptual stimuli did not modulate the task cueing by response, and the response was directly associated with the task. Thus, the results show that top-down control can be carried out even without conscious awareness, using response as a novel type of cue.",2022,"Unbeknownst to participants, the response-contingent group's response to the previous trial determined task type in the subsequent trial, while that of the random group was randomly determined.",[],['Implicit learning of a response-contingent task'],[],[],"[{'cui': 'C0013621', 'cui_str': 'Education'}]",[],,0.0137305,"Unbeknownst to participants, the response-contingent group's response to the previous trial determined task type in the subsequent trial, while that of the random group was randomly determined.","[{'ForeName': 'Injae', 'Initials': 'I', 'LastName': 'Hong', 'Affiliation': 'Department of Psychology, Yonsei University, Yonsei-ro 50 Seodaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Su Keun', 'Initials': 'SK', 'LastName': 'Jeong', 'Affiliation': 'Cognitive Science Research Group, Korea Brain Research Institute, Daegu, Republic of Korea.'}, {'ForeName': 'Min-Shik', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Department of Psychology, Yonsei University, Yonsei-ro 50 Seodaemun-gu, Seoul, Republic of Korea. kimm@yonsei.ac.kr.'}]","Attention, perception & psychophysics",['10.3758/s13414-021-02401-2']
3458,34949611,Effect of music on clinical outcome after hip fracture operations (MCHOPIN): study protocol of a multicentre randomised controlled trial.,"BACKGROUND


Patients undergoing proximal femur fracture surgery are at high risk of postoperative complications, with postoperative delirium occurring in 25%-40% of patients. Delirium has profound effects on patient outcome and recovery, the patient's family, caregivers and medical costs. Perioperative music has a beneficial effect on eliciting modifiable risk factors of delirium. Therefore, the aim of this trial was to evaluate the effect of perioperative recorded music on postoperative delirium in patients with proximal femur fracture undergoing surgery.
METHODS AND ANALYSIS


The Music on Clinical Outcome after Hip Fracture Operations study is an investigator-initiated, multicentre, randomised controlled, open-label, clinical trial. Five hundred and eight patients with proximal femur fracture meeting eligibility criteria will be randomised to the music intervention or control group with concealed allocation in a 1:1 ratio, stratified by hospital site. The perioperative music intervention consists of preselected lists totalling 30 hours of music, allowing participants to choose their preferred music from these lists (classical, jazz and blues, pop and Dutch). The primary outcome measure is postoperative delirium rate. Secondary outcome measures include pain, anxiety, medication requirement, postoperative complications, hospital length of stay and 30-day mortality. A 90-day follow-up will be performed in order to assess nursing home length of stay, readmission rate and functional ability to perform daily living activities. Furthermore, the cost and cost-effectiveness of the music intervention will be assessed. Data will be analysed according to an intention-to-treat principle.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Medical Research Ethics Committee Erasmus MC on 8 October 2018 (MEC-2018-110, NL64721.078.18). The trial will be carried out following the Declaration of Helsinki principles, Good Clinical Practice guidelines and Dutch Medical Research Involving Human Subjects Act. Research data will be reported following Consolidated Standards of Reporting Trials guidelines and study results will be published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NTR7036.",2021,"Secondary outcome measures include pain, anxiety, medication requirement, postoperative complications, hospital length of stay and 30-day mortality.","['Patients undergoing proximal femur fracture surgery', 'Five hundred and eight patients with proximal femur fracture meeting eligibility criteria', 'patients with proximal femur fracture undergoing surgery', 'hip fracture operations (MCHOPIN']","['music', 'music intervention or control group with concealed allocation', 'perioperative recorded music']","['cost and cost-effectiveness', 'postoperative delirium rate', 'pain, anxiety, medication requirement, postoperative complications, hospital length of stay and 30-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",508.0,0.444392,"Secondary outcome measures include pain, anxiety, medication requirement, postoperative complications, hospital length of stay and 30-day mortality.","[{'ForeName': 'Victor X', 'Initials': 'VX', 'LastName': 'Fu', 'Affiliation': 'Trauma Research Unit, Department of Surgery, Erasmus MC, Rotterdam, The Netherlands v.fu@erasmusmc.nl.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Jeekel', 'Affiliation': 'Department of Neuroscience, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'Esther M M', 'Initials': 'EMM', 'LastName': 'Van Lieshout', 'Affiliation': 'Trauma Research Unit, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Van der Velde', 'Affiliation': 'Department of Surgery, Sint Antonius Ziekenhuis, Utrecht, The Netherlands.'}, {'ForeName': 'Leonie J P', 'Initials': 'LJP', 'LastName': 'Slegers', 'Affiliation': 'Department of Anaesthesiology, Sint Antonius Ziekenhuis, Utrecht, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Haverlag', 'Affiliation': 'Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Haumann', 'Affiliation': 'Department of Anaesthesiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Marten J', 'Initials': 'MJ', 'LastName': 'Poley', 'Affiliation': 'Institute for Medical Technology Assessment, Erasmus Universiteit Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Michael H J', 'Initials': 'MHJ', 'LastName': 'Verhofstad', 'Affiliation': 'Trauma Research Unit, Department of Surgery, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2021-049706']
3459,34973284,"PTC923 (sepiapterin) lowers elevated blood phenylalanine in subjects with phenylketonuria: a phase 2 randomized, multi-center, three-period crossover, open-label, active controlled, all-comers study.","BACKGROUND & AIM


PTC923 (formerly CNSA-001), an oral formulation of sepiapterin, a natural precursor of intracellular tetrahydrobiopterin (BH 4 ), has been shown in humans to induce larger increases in circulating BH 4  vs. sapropterin dihydrochloride. Sapropterin reduces blood phenylalanine (Phe) by ≥20-30% in a minority of subjects with PKU. This was a Phase 2 randomized, multicenter, three-period crossover, open-label, active controlled, all-comers [regardless of phenylalanine hydroxylase (PAH) variants] comparison of PTC923 60 mg/kg, PTC923 20 mg/kg and sapropterin 20 mg/kg in 24 adults with phenylketonuria (PKU) and hyperphenylalaninemia.
METHODS


Eligible subjects were adult men or women (18-60 y) with PKU. Subjects enrolled received 7 days of once-daily oral treatment with PTC923 20 mg/kg/day, PTC923 60 mg/kg/day and sapropterin dihydrochloride 20 mg/kg/day each in a random order. Treatments were separated by a 7-day washout. Subjects maintained their usual pre-study diet, including consumption of amino acid mixtures. Blood Phe was measured on Day 1 (predose baseline), Day 3, Day 5, and Day 7 of each treatment period.
RESULTS


Least squares mean changes (SE) from baseline in blood Phe were: -206.4 (41.8) μmol/L for PTC923 60 mg/kg (p < 0.0001); -146.9 (41.8) μmol/L for PTC923 20 mg/kg (p = 0.0010); and - 91.5 (41.7) μmol/L for sapropterin (p = 0.0339). Effects of PTC923 60 mg/kg on blood Phe vs. sapropterin were significantly larger (p = 0.0098) and faster in onset with a significantly larger mean reduction in blood Phe at day 3 of treatment, p = 0.0135 (20 mg/kg) and p = 0.0007 (60 mg/kg). Only PTC923 60 mg/kg reduced blood Phe in classical PKU subjects (n = 11, p = 0.0287). The mean blood Phe reduction (PTC923 60 mg/kg) in a cofactor responder analysis (n = 8; baseline Phe ≥300 μmol/L and blood Phe reduction ≥30%) was -463.3 μmol/L (SE 51.5) from baseline. Adverse events were mostly mild to moderate, transient, and similar across treatment groups with no serious adverse events or discontinuations.
CONCLUSIONS


The substantially significantly better effect of PTC923 60 mg/kg on blood Phe reduction vs. sapropterin supports further clinical development of PTC923 for PKU; ANZCTR number, ACTRN12618001031257.",2022,"Adverse events were mostly mild to moderate, transient, and similar across treatment groups with no serious adverse events or discontinuations.
","['Eligible subjects were adult men or women (18-60 y) with PKU', 'subjects with phenylketonuria', '24 adults with phenylketonuria (PKU) and hyperphenylalaninemia']","['PTC923', 'PTC923 60\u202fmg/kg, PTC923 20\u202fmg/kg and sapropterin', 'PTC923 20\u202fmg/kg/day, PTC923 60\u202fmg/kg/day and sapropterin dihydrochloride', 'PTC923 (sepiapterin']","['blood phenylalanine', 'blood Phe vs. sapropterin', 'Adverse events', 'mean blood Phe reduction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0751435', 'cui_str': 'Hyperphenylalaninemia'}]","[{'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0048897', 'cui_str': 'Sapropterin'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C1996349', 'cui_str': 'Sapropterin dihydrochloride'}, {'cui': 'C0074349', 'cui_str': 'Sepiapterin'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0048897', 'cui_str': 'Sapropterin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",24.0,0.0678955,"Adverse events were mostly mild to moderate, transient, and similar across treatment groups with no serious adverse events or discontinuations.
","[{'ForeName': 'Drago', 'Initials': 'D', 'LastName': 'Bratkovic', 'Affiliation': 'PARC Clinical Research, Royal Adelaide Hospital, South Australia, Australia.'}, {'ForeName': 'Lali', 'Initials': 'L', 'LastName': 'Margvelashvili', 'Affiliation': 'Unimedi Kakheti, Tbilisi, Georgia.'}, {'ForeName': 'Michel C', 'Initials': 'MC', 'LastName': 'Tchan', 'Affiliation': 'Department of Genetic Medicine, Westmead Hospital, Australia and University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Nisbet', 'Affiliation': 'Mater Misericordiae Limited, Queensland Diabetes and Endocrine Centre, Brisbane, Queensland, Australia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Smith', 'Affiliation': 'PTC Therapeutics Inc, South Plainfield, NJ, USA. Electronic address: nsmith@ptcbio.com.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2021.155116']
3460,35001034,BMI and blood pressure control among United States adults with hypertension.,"OBJECTIVES


Less than half of United States adults with hypertension have controlled blood pressure (BP). Higher BMI is associated with an increased risk for hypertension but the association between BMI and BP control is not well characterized. We examined hypertension awareness, antihypertensive medication use, and BP control, by BMI category.
METHODS


Data for 3568 United States adults aged at least 18 years with hypertension (BP at least 140/90 mmHg or taking antihypertensive medication) from the 2015 to 2018 National Health and Nutrition Examination Survey were analyzed. BMI was categorized as normal (<25 kg/m2), overweight (25 to <30 kg/m2), class 1 obesity (30 to <35 kg/m2), or class 2 or 3 obesity (≥35 kg/m2). Hypertension awareness and antihypertensive medication use were self-reported. BP control was defined as BP less than 140/90 mmHg using the average of up to three measurements.
RESULTS


Among United States adults with hypertension, 15.6% had normal BMI, 31.3% had overweight, 26.2% had class 1 obesity, and 26.8% had class 2 or 3 obesity. Among those with normal BMI, overweight, class 1 obesity, and class 2 or 3 obesity: 67.9, 76.8, 84.0, and 87.8% were aware they had hypertension, respectively; 88.1, 88.1, 90.9, and 90.2% of those aware were taking antihypertensive medication, respectively; 63.5, 65.9, 71.1, and 64.1% of those taking antihypertensive medication had controlled BP, respectively; and 37.1, 44.3, 53.8, and 50.8% of those with hypertension had controlled BP, respectively.
CONCLUSION


United States adults with hypertension and normal BMI were less likely to be aware they had hypertension and have controlled BP compared with those with overweight or obesity.",2022,"Among those with normal BMI, overweight, class 1 obesity, and class 2 or 3 obesity: 67.9, 76.8, 84.0, and 87.8% were aware they had hypertension, respectively; 88.1, 88.1, 90.9, and 90.2% of those aware were taking antihypertensive medication, respectively; 63.5, 65.9, 71.1, and 64.1% of those taking antihypertensive medication had controlled BP, respectively; and 37.1, 44.3, 53.8, and 50.8% of those with hypertension had controlled BP, respectively.
","['United States adults with hypertension, 15.6% had normal BMI, 31.3% had overweight, 26.2% had class 1 obesity, and 26.8% had class 2 or 3 obesity', 'United States adults with hypertension', 'Among those with normal BMI, overweight, class 1 obesity, and class 2 or 3 obesity: 67.9, 76.8, 84.0, and 87.8% were aware they had hypertension, respectively; 88.1, 88.1, 90.9, and 90.2% of those aware were taking antihypertensive medication, respectively; 63.5, 65.9, 71.1, and 64.1% of those taking antihypertensive medication had controlled BP, respectively; and 37.1, 44.3, 53.8, and 50.8% of those with hypertension had controlled BP, respectively', 'Less than half of United States adults with hypertension have controlled blood pressure (BP', '3568 United States adults aged at least 18\u200ayears with hypertension (BP at least 140/90\u200ammHg or taking antihypertensive medication) from the 2015 to 2018 National Health and Nutrition Examination Survey were analyzed']",[],"['BMI', 'BMI and blood pressure control', 'BP control']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0376344', 'cui_str': 'NHANES'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0450683,"Among those with normal BMI, overweight, class 1 obesity, and class 2 or 3 obesity: 67.9, 76.8, 84.0, and 87.8% were aware they had hypertension, respectively; 88.1, 88.1, 90.9, and 90.2% of those aware were taking antihypertensive medication, respectively; 63.5, 65.9, 71.1, and 64.1% of those taking antihypertensive medication had controlled BP, respectively; and 37.1, 44.3, 53.8, and 50.8% of those with hypertension had controlled BP, respectively.
","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Foti', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health.'}, {'ForeName': 'Shakia T', 'Initials': 'ST', 'LastName': 'Hardy', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham School of Public Health, Birmingham, Alabama.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Chang', 'Affiliation': 'Kidney Health Research Institute, Geisinger Health, Danville, Pennsylvania, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Selvin', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Coresh', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham School of Public Health, Birmingham, Alabama.'}]",Journal of hypertension,['10.1097/HJH.0000000000003072']
3461,34990999,Metabolomics changes after rTMS intervention reveal potential peripheral biomarkers in methamphetamine dependence.,"Methamphetamine is one of the most commonly used drugs around the world, leading to serious public health and psychiatric problems. Due to the lackness of objective laboratory evaluation indicators, the molecular mechanisms of methamphetamine dependence still remain unclear. Previous evidence demonstrated that repetitive transcranial magnetic stimulation (rTMS) may be useful in treating drug addiction. The aim of this study was to identify and validate plasma metabolomics biomarkers in patients with methamphetamine use disorder before and after rTMS intervention. An untargeted gas chromatography-time-of-flight mass spectrometry (GC-TOFMS) based metabolomics approach was applied to characterize the metabolic profile of forty methamphetamine dependent subjects and thirty-eight healthy controls in peripheral blood mononuclear cells (PBMCs). Patients were randomized to receive either rTMS or sham over the DLPFC for four weeks (20 daily sessions, 900 pulses per day). Cognitive function were assessed before and after rTMS intervention. Eight PBMC metabolites responsible for distinguishing real rTMS from sham treatment were identified. These metabolites were mainly involved in energy metabolism and oxidative stress. Compared with baseline, the expression of three metabolites was reversed after rTMS intervention: alpha-tocopherol, glyceric acid and fumaric acid. Changes of the alpha-tocopherol were associated with cognitive function improvement following rTMS. These findings suggest that energy metabolism and oxidative stress system may be associated with the effect of rTMS on cognitive function in methamphetamine dependence, and warrant further investigation.",2022,"Compared with baseline, the expression of three metabolites was reversed after rTMS intervention: alpha-tocopherol, glyceric acid and fumaric acid.","['methamphetamine dependence', 'patients with methamphetamine use disorder before and after rTMS intervention', 'forty methamphetamine dependent subjects and thirty-eight healthy controls in peripheral blood mononuclear cells (PBMCs']","['rTMS', 'rTMS or sham over the DLPFC', 'repetitive transcranial magnetic stimulation (rTMS', 'rTMS intervention', 'Methamphetamine']",['Cognitive function'],"[{'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0148631,"Compared with baseline, the expression of three metabolites was reversed after rTMS intervention: alpha-tocopherol, glyceric acid and fumaric acid.","[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Pingyuan', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Deng', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Sufang', 'Initials': 'S', 'LastName': 'Peng', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China. Electronic address: sufangpeng@126.com.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; CAS Center for Excellence in Brain Science and Intelligence Technology (CEBSIT), Chinese Academy of Sciences, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2021.12.006']
3462,34992327,Development and two-phased pilot RCT of a foster/kinship caregiver intervention to improve sexual health communication with youth.,"Purpose


Foster youth have high rates of unintended teen pregnancies and other negative sexual health outcomes. Foster and kinship caregivers (FKC) are an untapped resource to reduce risks. We conducted a two-phase pilot study to evaluate feasibility, acceptability and assess preliminary efficacy of a training designed to improve caregiver communication, monitoring and conflict behaviors and improve sexual health outcomes for youth in foster care. Our study included a Randomized Controlled Trial (RCT) component.
Method


Phase 1:  We recruited 49 FKC and assessed feasibility quantitatively, and acceptability both qualitatively and quantitatively of our intervention (Heart to Heart).  Phase 2 : We conducted an RCT with 71 participants and evaluated caregiver communication, monitoring, and conflict behaviors as well as the psychological determinants thereof in intervention and control groups at 1, 3, and 6 months.
Results


Phase 1:  Facilitators delivered all intervention content; >90% participants received the entire training. The intervention was highly acceptable (mean score 4.9/5 on two questions).  Phase 2:  71 participants were eligible and completed baseline (68 completed at least one follow up survey). We found significant improvements in the intervention group in knowledge, communication expectations, and caregiver-youth conflict behaviors in one or more waves; the control group demonstrated no significant improvements. When groups were compared, we found significant differences in knowledge, communication frequency, and conflict behaviors at 6 months.
Conclusions


Heart to Heart is feasible, acceptable, and preliminary outcomes data is promising. More research is needed to better establish evidence of efficacy for long-term behavior change in caregivers and youth.
ClinicalTrialsgov identifer


NCT03331016.",2021,"We found significant improvements in the intervention group in knowledge, communication expectations, and caregiver-youth conflict behaviors in one or more waves; the control group demonstrated no significant improvements.","['youth in foster care', 'sexual health communication with youth', '71 participants were eligible and completed baseline (68 completed at least one follow up survey']",['kinship caregiver intervention'],"['knowledge, communication frequency, and conflict behaviors', 'sexual health outcomes', 'caregiver communication, monitoring and conflict behaviors', 'knowledge, communication expectations, and caregiver-youth conflict behaviors']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]",71.0,0.0326152,"We found significant improvements in the intervention group in knowledge, communication expectations, and caregiver-youth conflict behaviors in one or more waves; the control group demonstrated no significant improvements.","[{'ForeName': 'Kym R', 'Initials': 'KR', 'LastName': 'Ahrens', 'Affiliation': ""Center for Child Health, Behavior, and Development Research, Seattle Children's Research Institute, Seattle, WA.""}, {'ForeName': 'Wadiya', 'Initials': 'W', 'LastName': 'Udell', 'Affiliation': 'School of Interdisciplinary Arts and Sciences, University of Washington, Bothell WA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Albertson', 'Affiliation': ""Center for Child Health, Behavior, and Development Research, Seattle Children's Research Institute, Seattle, WA.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lowry', 'Affiliation': ""Center for Child Health, Behavior, and Development Research, Seattle Children's Research Institute, Seattle, WA.""}, {'ForeName': 'Teah', 'Initials': 'T', 'LastName': 'Hoopes', 'Affiliation': 'Public Health - Seattle and King County, Seattle, WA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Coatney', 'Affiliation': ""Center for Child Health, Behavior, and Development Research, Seattle Children's Research Institute, Seattle, WA.""}]",Children and youth services review,['10.1016/j.childyouth.2020.105877']
3463,34937721,Metabolic Surgery Supporting Aftercare via Group-Intervention (MeSSAGES): study protocol of a randomised controlled trial.,"INTRODUCTION


Obesity is a constantly rising and cost-intensive medical issue worldwide. Severe obesity often needs surgery to promote weight loss, but due to the rapid therapeutic success after the surgery, many patients lack the awareness of the need to consistently maintain the postoperative care. However, therapeutic success and psychological well-being can be increased through group interventions and social support of the group members. Therefore, aftercare via group intervention is a promising approach. In this prospective randomised controlled study, the self-efficacy in a social media-based interactive, psychoeducational intervention is to be tested.
METHODS AND ANALYSIS


The intervention group will complete a social media-supported group intervention for 6 weeks with weekly postings of educative contents and the possibility to exchange in groups via anonymous avatars. The control group will receive treatment as usual (TAU) after the obesity surgery as recommended in the German S3-guidelines Obesity Surgery and Metabolic Surgery. We will examine the effectiveness of a social media-supported intervention group, and therefore, the change in self-efficacy expectation. For the primary outcome, we will perform a mixed analysis of variance with time as the within-subject factor (times of measurement T0-T4) and the group assignment as the between-subject factor (intervention +TAU vs TAU group).
ETHICS AND DISSEMINATION


The study was approved by the Medical Association North Rhine (Ärztekammer Nordrhein, 2020031) and the patient enrolment will begin in July 2021.
TRIAL REGISTRATION NUMBER


DRKS00018089.",2021,"In this prospective randomised controlled study, the self-efficacy in a social media-based interactive, psychoeducational intervention is to be tested.
",[],"['social media-based interactive, psychoeducational intervention', 'social media-supported intervention', 'Metabolic Surgery Supporting Aftercare via Group-Intervention (MeSSAGES']",[],[],"[{'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],,0.0322548,"In this prospective randomised controlled study, the self-efficacy in a social media-based interactive, psychoeducational intervention is to be tested.
","[{'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Skoda', 'Affiliation': 'Clinic for Psychosomatic Medicine and Psychotherapy, LVR Hospital Essen, University of Duisburg-Essen, Essen, Germany eva-maria.skoda@uni-due.de.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Steinbach', 'Affiliation': 'Clinic for Psychosomatic Medicine and Psychotherapy, LVR Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Robitzsch', 'Affiliation': 'Clinic for Psychosomatic Medicine and Psychotherapy, LVR Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Pfeiffer', 'Affiliation': 'Clinic for Psychosomatic Medicine and Psychotherapy, LVR Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Lynik', 'Initials': 'L', 'LastName': 'Schüren', 'Affiliation': 'Department of Surgery, Alfried Krupp Klinikum Essen, Essen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Tomaszewski', 'Affiliation': 'Johnson & Johnson Medical GmbH, Norderstedt, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Niedergethman', 'Affiliation': 'Department of Surgery, Alfried Krupp Klinikum Essen, Essen, Germany.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Schweda', 'Affiliation': 'Clinic for Psychosomatic Medicine and Psychotherapy, LVR Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bäuerle', 'Affiliation': 'Clinic for Psychosomatic Medicine and Psychotherapy, LVR Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Teufel', 'Affiliation': 'Clinic for Psychosomatic Medicine and Psychotherapy, LVR Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}]",BMJ open,['10.1136/bmjopen-2021-053839']
3464,34937717,"PARIS: protocol for a prospective single arm, theory-based, group-based feasibility intervention study to increase Physical Activity and reduce sedentary behaviouR after barIatric Surgery.","INTRODUCTION


Increased physical activity and reduced sedentary behaviour can encourage favourable outcomes after bariatric surgery. However, there is a lack of evidence as to how to support patients with behaviour change. The aim of this study is to assess the feasibility of a physiotherapist led, online group-based behaviour change intervention to increase physical activity and reduce sedentary behaviour following bariatric surgery.
METHODS AND ANALYSIS


Single arm feasibility study of a theory and evidence-based group behaviour change intervention based on the Behaviour Change Wheel and Theoretical Domains Framework using behaviour change techniques from the Behaviour Change Technique Taxonomy v1. The intervention has eight objectives and specifies behaviour change techniques that will be used to address each of these. Groups of up to eight participants who have had surgery within the previous 5 years will meet weekly over 6 weeks for up to 1½ hours. Groups will be held online led by a physiotherapist and supported by an intervention handbook. Feasibility study outcomes include: rate of recruitment, retention, intervention fidelity, participant engagement and acceptability. Secondary outcomes include: physical activity, sedentary behaviour, body composition, self-reported health status and will be analysed descriptively. Change in these outcomes will be used to calculate the sample size for a future evaluation study. Qualitative interviews will explore participants' views of the intervention including its acceptability. Data will be analysed according to the constant comparative approach of grounded theory.
ETHICS AND DISSEMINATION


This study has National Health Service Research Ethics Committee approval; Haydock 20/NW/0472. All participants will provide informed consent and can withdraw at any point. Findings will be disseminated through peer-reviewed journals, conference and clinical service presentations.
TRIAL REGISTRATION NUMBER


ISRCTN31524689.",2021,"The aim of this study is to assess the feasibility of a physiotherapist led, online group-based behaviour change intervention to increase physical activity and reduce sedentary behaviour following bariatric surgery.
",['Groups of up to eight participants who have had surgery within the previous 5 years'],"['physiotherapist led, online group-based behaviour change intervention', 'theory and evidence-based group behaviour change intervention']","['rate of recruitment, retention, intervention fidelity, participant engagement and acceptability', 'sedentary behaviouR', 'physical activity, sedentary behaviour, body composition, self-reported health status and will be analysed descriptively', 'sedentary behaviour']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",8.0,0.0514678,"The aim of this study is to assess the feasibility of a physiotherapist led, online group-based behaviour change intervention to increase physical activity and reduce sedentary behaviour following bariatric surgery.
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'James', 'Affiliation': 'Department of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK jennifer.james@liverpool.ac.uk.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hardeman', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Eborall', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Goodall', 'Affiliation': 'Primary care and Mental Health, Institute of Population Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wilding', 'Affiliation': 'Department of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK.'}]",BMJ open,['10.1136/bmjopen-2021-051638']
3465,34997525,"Does quality assured eLearning provide adequate preparation for robotic surgical skills; a prospective, randomized and multi-center study.","PURPOSE


In particular after the onset of the COVID-19 pandemic, there was a precipitous rush to implement virtual and online learning strategies in surgery and medicine. It is essential to understand whether this approach is sufficient and adequate to allow the development of robotic basic surgical skills. The main aim of the authors was to verify if the quality assured eLearning is sufficient to prepare individuals to perform a basic surgical robotic task.
METHODS


A prospective, randomized and multi-center study was conducted in September 2020 in the ORSI Academy, International surgical robotic training center. Forty-seven participants, with no experience but a special interest in robotic surgery, were matched and randomized into four groups who underwent a didactic preparation with different formats before carrying out a robotic suturing and anastomosis task. Didactic preparation methods ranged from a complete eLearning path to peer-reviewed published manuscripts describing the suturing, knot tying and task assessment metrics.
RESULTS


The primary outcome was the percentage of trainees who demonstrated the quantitatively defined proficiency benchmark after learning to complete an assisted but unaided robotic vesico-urethral anastomosis task. The quantitatively defined benchmark was based on the objectively assessed performance (i.e., procedure steps completed, errors and critical errors) of experienced robotic surgeons for a proficiency-based progression (PBP) training course. None of the trainees in this study demonstrated the proficiency benchmarks in completing the robotic surgery task.
CONCLUSIONS


PBP-based e-learning methodology is an effective training method avoiding critical errors in the suturing and knotting task. Quality assured online learning is insufficient preparation for robotic suturing and knot tying anastomosis skills.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04541615.",2022,"CONCLUSIONS


PBP-based e-learning methodology is an effective training method avoiding critical errors in the suturing and knotting task.","['Forty-seven participants, with no experience but a special interest in robotic surgery', 'September 2020 in the ORSI Academy, International surgical robotic training center']",['didactic preparation with different formats before carrying out a robotic suturing and anastomosis task'],['percentage of trainees who demonstrated the quantitatively defined proficiency benchmark after learning to complete an assisted but unaided robotic vesico-urethral anastomosis task'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0557814', 'cui_str': 'Training center'}]","[{'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439846', 'cui_str': 'Unaided'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0565280', 'cui_str': 'Urethral anastomosis'}]",,0.0254138,"CONCLUSIONS


PBP-based e-learning methodology is an effective training method avoiding critical errors in the suturing and knotting task.","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Puliatti', 'Affiliation': 'ORSI Academy, Melle, Belgium. stefanopuliatti@gmail.com.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Amato', 'Affiliation': 'ORSI Academy, Melle, Belgium.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Farinha', 'Affiliation': 'ORSI Academy, Melle, Belgium.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Paludo', 'Affiliation': 'ORSI Academy, Melle, Belgium.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Rosiello', 'Affiliation': 'ORSI Academy, Melle, Belgium.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'De Groote', 'Affiliation': 'ORSI Academy, Melle, Belgium.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mari', 'Affiliation': 'Unit of Oncologic Minimally Invasive Urology and Andrology, Department of Urology, University of Florence, Careggi Hospital, Florence, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Bianchi', 'Affiliation': 'Office for the Vice President for Learning and Teaching, University College Cork, Cork, Ireland.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Piazza', 'Affiliation': 'ORSI Academy, Melle, Belgium.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Van Cleynenbreugel', 'Affiliation': 'Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Mazzone', 'Affiliation': 'Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Migliorini', 'Affiliation': 'Urology Unit, Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Forte', 'Affiliation': 'Urology and Andrology Unit II, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Rocco', 'Affiliation': 'Urology Department, ASST Santi Paolo e Carlo - Milano, Università Statale di Milano, Milan, Italy.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kiely', 'Affiliation': 'ORSI Academy, Melle, Belgium.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mottrie', 'Affiliation': 'ORSI Academy, Melle, Belgium.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'ORSI Academy, Melle, Belgium.'}]",International journal of computer assisted radiology and surgery,['10.1007/s11548-021-02545-4']
3466,35002538,Changes of Endothelin-1 and Calcitonin Gene-Related Peptide Concentrations in Patients with Cervical Radiculopathy after Wrist-Ankle Acupuncture-Moxibustion and Hot Compression with Chinese Herbal Medicine.,"Objective


This study aimed at investigating the effects of wrist-ankle acupuncture-moxibustion and hot compression with Chinese herbal medicine on pain symptoms, endothelin-1 (ET-1), and calcitonin gene-related peptide (CGRP) concentrations of patients with cervical radiculopathy (CR).
Methods


A total of 82 patients with CR were randomly divided into the study group and control group, with 41 cases in each group. The control group was treated with standard treatment. In addition to standard treatment, the study group was additionally treated with wrist-ankle acupuncture-moxibustion and hot compression with Chinese herbal medicine. The ET-1 and CGRP concentrations in the plasma were measured by the radioimmunoassay method.
Results


The total response rate in the study group and the control group was 97.55% and 82.93%, respectively. The study group showed lower scores of the visual analogue scale (VAS), Northwick Park Neck Pain Questionnaire (NPQ), McGill Pain Questionnaire (MPQ), numbness intensity assessment, and neck disability index (NDI) but higher scores of the Short Form-36 (SF-36) health survey questionnaire than the control group after treatment. Besides, the study group exhibited reduced ET-1 and substance P (SP) concentrations concomitant with increased CGRP and  β -endorphin ( β -EP) concentrations compared with the control group.
Conclusion


Wrist-ankle acupuncture-moxibustion and hot compression with Chinese herbal medicine could effectively alleviate the pain of CR patients, affect ET-1 and CGRP concentrations, promote the recovery of cervical function, and improve the quality of life.",2021,"The study group showed lower scores of the visual analogue scale (VAS), Northwick Park Neck Pain Questionnaire (NPQ), McGill Pain Questionnaire (MPQ), numbness intensity assessment, and neck disability index (NDI) but higher scores of the Short Form-36 (SF-36) health survey questionnaire than the control group after treatment.","['patients with cervical radiculopathy (CR', 'Patients with Cervical Radiculopathy after Wrist-Ankle Acupuncture-Moxibustion and Hot Compression with Chinese Herbal Medicine', '82 patients with CR']","['acupuncture-moxibustion and hot compression with Chinese herbal medicine', 'wrist-ankle acupuncture-moxibustion and hot compression with Chinese herbal medicine']","['visual analogue scale (VAS), Northwick Park Neck Pain Questionnaire (NPQ), McGill Pain Questionnaire (MPQ), numbness intensity assessment, and neck disability index (NDI) but higher scores of the Short Form-36 (SF-36) health survey questionnaire', 'pain of CR patients, affect ET-1 and CGRP concentrations', 'pain symptoms, endothelin-1 (ET-1), and calcitonin gene-related peptide (CGRP) concentrations', 'total response rate', 'ET-1 and substance P (SP) concentrations concomitant with increased CGRP and  β -endorphin', 'ET-1 and CGRP concentrations', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0742186', 'cui_str': 'Cervical radiculopathy'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0742186', 'cui_str': 'Cervical radiculopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0014242', 'cui_str': 'Endorphin'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",82.0,0.0654042,"The study group showed lower scores of the visual analogue scale (VAS), Northwick Park Neck Pain Questionnaire (NPQ), McGill Pain Questionnaire (MPQ), numbness intensity assessment, and neck disability index (NDI) but higher scores of the Short Form-36 (SF-36) health survey questionnaire than the control group after treatment.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Integrated Chinese and Western Medicine, Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha, Hunan 410016, China.""}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Department of Nephrology, Guangdong Province Traditional Chinese Medicine Hospital, Guangzhou, China.'}, {'ForeName': 'Yanghong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Integrated Chinese and Western Medicine, Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha, Hunan 410016, China.""}, {'ForeName': 'Sishi', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Integrated Chinese and Western Medicine, Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha, Hunan 410016, China.""}]",Genetics research,['10.1155/2021/5433742']
3467,34911681,Tadalafil Enhances Immune Signatures in Response to Neoadjuvant Nivolumab in Resectable Head and Neck Squamous Cell Carcinoma.,"PURPOSE


We hypothesize that the addition of the phosphodiesterase-5 inhibitor tadalafil to the PD-1 inhibitor nivolumab, is safe and will augment immune-mediated antitumor responses in previously untreated squamous cell carcinoma of the head and neck (HNSCC).
PATIENTS AND METHODS


We conducted a two-arm multi-institutional neoadjuvant randomized trial in any-stage resectable HNSCC (NCT03238365). Patients were stratified at randomization by human papillomavirus (HPV) status. Patients in both arms received nivolumab 240 mg intravenously on days 1 and 15 followed by surgery on day 28. Those in the combination therapy arm also received tadalafil 10 mg orally once daily for 4 weeks. Imaging, blood, and tumor were obtained pretreatment and posttreatment for correlative analysis.
RESULTS


Neoadjuvant therapy was well-tolerated with no grade 3 to 5 adverse events and no surgical delays. Twenty-five of 46 (54%) evaluable patients had a pathologic treatment response of ≥20%, including three (7%) patients with a complete pathologic response. Regardless of HPV status, tumor proliferation rate was a negative predictor of response. A strong pretreatment T-cell signature in the HPV-negative cohort was a predictor of response. Tadalafil altered the immune microenvironment, as evidenced by transcriptome data identifying enriched B- and natural killer cell gene sets in the tumor and augmented effector T cells in the periphery.
CONCLUSIONS


Preoperative nivolumab ± tadalafil is safe in HNSCC and results in more than 50% of the patients having a pathologic treatment response of at least 20% after 4 weeks of treatment. Pretreatment specimens identified HPV status-dependent signatures that predicted response to immunotherapy while posttreatment specimens showed augmentation of the immune microenvironment with the addition of tadalafil.",2022,"Tadalafil altered the immune microenvironment, as evidenced by transcriptome data identifying enriched B- and natural killer cell gene sets in the tumor and augmented effector T cells in the periphery.
","['previously untreated squamous cell carcinoma of the head and neck (HNSCC', 'Resectable Head and Neck Squamous Cell Carcinoma']","['tadalafil', 'nivolumab', 'Preoperative nivolumab ± tadalafil', 'phosphodiesterase-5 inhibitor tadalafil', 'Tadalafil']","['pathologic treatment response', 'HPV status, tumor proliferation rate']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1318700', 'cui_str': 'Phosphodiesterase 5 inhibitor'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}]",,0.0406349,"Tadalafil altered the immune microenvironment, as evidenced by transcriptome data identifying enriched B- and natural killer cell gene sets in the tumor and augmented effector T cells in the periphery.
","[{'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Luginbuhl', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Thomas Jefferson University Hospitals, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Johnson', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Harshyne', 'Affiliation': 'Department of Cancer Biology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alban J', 'Initials': 'AJ', 'LastName': 'Linnenbach', 'Affiliation': 'Department of Dermatology and Cutaneous Biology, Sidney Kimmel Medical College, Thomas Jefferson University; Philadelphia, Pennsylvania.'}, {'ForeName': 'Sanket K', 'Initials': 'SK', 'LastName': 'Shukla', 'Affiliation': 'Department of Dermatology and Cutaneous Biology, Sidney Kimmel Medical College, Thomas Jefferson University; Philadelphia, Pennsylvania.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Alnemri', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Thomas Jefferson University Hospitals, Philadelphia, Pennsylvania.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Department of Cancer Biology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Cognetti', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Thomas Jefferson University Hospitals, Philadelphia, Pennsylvania.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Curry', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Thomas Jefferson University Hospitals, Philadelphia, Pennsylvania.'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Kotlov', 'Affiliation': 'BostonGene Corporation, Waltham, Massachusetts.'}, {'ForeName': 'Zoya', 'Initials': 'Z', 'LastName': 'Antysheva', 'Affiliation': 'BostonGene Corporation, Waltham, Massachusetts.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Degryse', 'Affiliation': 'BostonGene Corporation, Waltham, Massachusetts.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Mannion', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Gibson', 'Affiliation': 'Division of Hematology and Oncology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Netterville', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Brandee', 'Initials': 'B', 'LastName': 'Brown', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Axelrod', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Zinner', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Madalina', 'Initials': 'M', 'LastName': 'Tuluc', 'Affiliation': 'Department of Pathology, Anatomy and Cell Biology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Gargano', 'Affiliation': 'Department of Pathology, Anatomy and Cell Biology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Leiby', 'Affiliation': 'Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Shimada', 'Affiliation': 'Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'My G', 'Initials': 'MG', 'LastName': 'Mahoney', 'Affiliation': 'Department of Dermatology and Cutaneous Biology, Sidney Kimmel Medical College, Thomas Jefferson University; Philadelphia, Pennsylvania.'}, {'ForeName': 'Ubaldo', 'Initials': 'U', 'LastName': 'Martinez-Outschoorn', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Rodeck', 'Affiliation': 'Department of Dermatology and Cutaneous Biology, Sidney Kimmel Medical College, Thomas Jefferson University; Philadelphia, Pennsylvania.'}, {'ForeName': 'Young J', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'South', 'Affiliation': 'Department of Dermatology and Cutaneous Biology, Sidney Kimmel Medical College, Thomas Jefferson University; Philadelphia, Pennsylvania.'}, {'ForeName': 'Athanassios', 'Initials': 'A', 'LastName': 'Argiris', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-1816']
3468,34887261,Trilaciclib Prior to Chemotherapy in Patients with Metastatic Triple-Negative Breast Cancer: Final Efficacy and Subgroup Analysis from a Randomized Phase II Study.,"PURPOSE


We report final antitumor efficacy results from a phase II study of trilaciclib, an intravenous cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, administered prior to gemcitabine plus carboplatin (GCb) in patients with metastatic triple-negative breast cancer (NCT02978716).
PATIENTS AND METHODS


Patients were randomized (1:1:1) to group 1 [GCb (days 1, 8); n = 34], group 2 [trilaciclib prior to GCb (days 1, 8); n = 33], or group 3 [trilaciclib (days 1, 8) and trilaciclib prior to GCb (days 2, 9); n = 35]. Subgroup analyses were performed according to CDK4/6 dependence, level of programmed death-ligand 1 (PD-L1) expression, and RNA-based immune signatures using proportional hazards regression. T-cell receptor (TCR) β CDR3 regions were amplified and sequenced to identify, quantify, and compare the abundance of each unique TCRβ CDR3 at baseline and on treatment.
RESULTS


Median overall survival (OS) was 12.6 months in group 1, not reached in group 2 (HR = 0.31; P = 0.0016), 17.8 months in group 3 (HR = 0.40; P = 0.0004), and 19.8 months in groups 2 and 3 combined (HR = 0.37; P < 0.0001). Efficacy outcomes were comparable regardless of cancer CDK4/6 dependence status and immune signatures. Administering trilaciclib prior to GCb prolonged OS irrespective of PD-L1 status but had greater benefit in the PD-L1-positive population. T-cell activation was enhanced in patients receiving trilaciclib.
CONCLUSIONS


Administering trilaciclib prior to GCb enhanced antitumor efficacy, with significant improvements in OS. Efficacy outcomes in immunologic subgroups and enhancements in T-cell activation suggest these improvements may be mediated via immunologic mechanisms.",2022,Administering trilaciclib prior to GCb prolonged OS irrespective of PD-L1 status but had greater benefit in the PD-L1-positive population.,"['Patients with Metastatic Triple-Negative Breast Cancer', 'patients with metastatic triple-negative breast cancer (NCT02978716']","['intravenous cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, administered prior to gemcitabine plus carboplatin (GCb', 'group 2 [trilaciclib prior to GCb (days 1, 8);  n  = 33], or group 3 [trilaciclib (days 1, 8) and trilaciclib prior to GCb', 'Trilaciclib Prior to Chemotherapy']","['cancer CDK4/6 dependence status and immune signatures', 'T-cell receptor (TCR', 'OS', 'T-cell activation', 'Median overall survival (OS', 'CDK4/6 dependence, level of programmed death-ligand 1 (PD-L1) expression, and RNA-based immune signatures', 'antitumor efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0243045', 'cui_str': 'cdk Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0243045', 'cui_str': 'cdk Proteins'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0034790', 'cui_str': 'T-cell antigen receptor'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0675381,Administering trilaciclib prior to GCb prolonged OS irrespective of PD-L1 status but had greater benefit in the PD-L1-positive population.,"[{'ForeName': 'Antoinette R', 'Initials': 'AR', 'LastName': 'Tan', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Gail S', 'Initials': 'GS', 'LastName': 'Wright', 'Affiliation': 'Florida Cancer Specialists and Research Institute, New Port Richey, Florida.'}, {'ForeName': 'Anu R', 'Initials': 'AR', 'LastName': 'Thummala', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Danso', 'Affiliation': 'Virginia Oncology Associates, Norfolk, Virginia.'}, {'ForeName': 'Lazar', 'Initials': 'L', 'LastName': 'Popovic', 'Affiliation': 'Oncology Institute of Vojvodina, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Pluard', 'Affiliation': ""Saint Luke's Cancer Institute, Kansas City, Missouri.""}, {'ForeName': 'Hyo S', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}, {'ForeName': 'Željko', 'Initials': 'Ž', 'LastName': 'Vojnović', 'Affiliation': 'Varaždin General Hospital, Varaždin, Croatia.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Vasev', 'Affiliation': 'University Clinic of Radiotherapy and Oncology, Skopje, North Macedonia.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Rocky Mountain Cancer Centers, Lakewood, Colorado.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Richards', 'Affiliation': 'Texas Oncology-Tyler, US Oncology Research, Tyler, Texas.'}, {'ForeName': 'Sharon T', 'Initials': 'ST', 'LastName': 'Wilks', 'Affiliation': 'Texas Oncology-San Antonio, US Oncology Research, San Antonio, Texas.'}, {'ForeName': 'Dušan', 'Initials': 'D', 'LastName': 'Milenković', 'Affiliation': 'Clinical Center Niš, Niš, Serbia.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'G1 Therapeutics, Inc., Research Triangle Park, North Carolina.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Sorrentino', 'Affiliation': 'G1 Therapeutics, Inc., Research Triangle Park, North Carolina.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Horton', 'Affiliation': 'G1 Therapeutics, Inc., Research Triangle Park, North Carolina.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Research, Dallas, Texas.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-2272']
3469,34937722,Multicomponent intervention to improve blood pressure management in chronic kidney disease: a protocol for a pragmatic clinical trial.,"INTRODUCTION


The purpose of this study is to incorporate behavioural economic principles and user-centred design principles into a multicomponent intervention for the management of uncontrolled hypertension (HTN) in chronic kidney disease (CKD) in primary care.
METHODS AND ANALYSIS


This is a multicentre, pragmatic, controlled trial cluster-randomised at the clinician level at The Brigham and Women's Practice -Based Research Network of 15 practices. Of 220 total clinicians, 184 were eligible to be enrolled, and the remainder were excluded (residents and clinicians who see urgent care or walk-in patients); no clinicians opted out. The intervention consists of a clinical decision support system based in behavioural economic and user-centred design principles that will: (1) synthesise existing laboratory tests, medication orders and vital sign data; (2) increase recognition of CKD, (3) increase recognition of uncontrolled HTN in CKD patients and (4) deliver evidence-based CKD and HTN management recommendations. The primary endpoint is the change in mean systolic blood pressure between baseline and 6 months compared across arms. We will use the Reach Effectiveness Adoption Implementation Maintenance framework. At the conclusion of this study, we will have: (1) validated an intervention that combines laboratory tests, medication records and clinical information collected by electronic health records to recognise uncontrolled HTN in CKD patients and recommend a course of care, (2) tested the effectiveness of said intervention and (3) collected information about the implementation of the intervention that will aid in dissemination of the intervention to other practice settings.
ETHICS AND DISSEMINATION


The Human Subjects Institutional Review Board at Brigham and Women's Hospital provided an expedited review and approval for this study protocol, and a Data Safety Monitoring Board will ensure the ongoing safety of the trial.
TRIAL REGISTRATION NUMBER


NCT03679247.",2021,"The intervention consists of a clinical decision support system based in behavioural economic and user-centred design principles that will: (1) synthesise existing laboratory tests, medication orders and vital sign data; (2) increase recognition of CKD, (3) increase recognition of uncontrolled HTN in CKD patients and (4) deliver evidence-based CKD and HTN management recommendations.","['chronic kidney disease', 'uncontrolled hypertension (HTN) in chronic kidney disease (CKD) in primary care', 'Of 220 total clinicians, 184 were eligible to be enrolled, and the remainder were excluded (residents and clinicians who see urgent care or walk-in patients); no clinicians opted out']","['Multicomponent intervention', 'multicomponent intervention']","['blood pressure management', 'change in mean systolic blood pressure']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0625565,"The intervention consists of a clinical decision support system based in behavioural economic and user-centred design principles that will: (1) synthesise existing laboratory tests, medication orders and vital sign data; (2) increase recognition of CKD, (3) increase recognition of uncontrolled HTN in CKD patients and (4) deliver evidence-based CKD and HTN management recommendations.","[{'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Kilgallon', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts, USA jkilgallon@bwh.harvard.edu.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gannon', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Burns', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Gearoid', 'Initials': 'G', 'LastName': 'McMahon', 'Affiliation': ""Division of Nephrology, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Dykes', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Linder', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'David Westfall', 'Initials': 'DW', 'LastName': 'Bates', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Sushrut', 'Initials': 'S', 'LastName': 'Waikar', 'Affiliation': 'Nephrology, Department of Medicine, Boston University Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Lipsitz', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Baer', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Samal', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}]",BMJ open,['10.1136/bmjopen-2021-054065']
3470,35007684,"Effect of Ustukhuddus Alavi, a multi-herbal product, on the cognitive performance of adolescent female students.","ETHNOPHARMACOLOGICAL RELEVANCE


Ustukhuddus Alavi is a polyherbal formula which is introduced by Persian medicine scholars. It is traditionally used to treat brain disorders and is claimed to do so by preprocessing and cleansing the waste products from the brain. According to Persian medicine, the disposal of brain waste products is necessary for optimal cognitive performance.
AIM OF THE STUDY


Sustaining optimal cognitive performance is crucial for ideal quality of life and higher academic achievements in high school students. The objective of this study was to determine the effects of this multi-component herbal product on the cognitive performance and salivary cortisol levels of adolescent female students.
MATERIALS AND METHODS


The effect of a 6-week randomly assigned Ustukhuddus Alavi versus placebo administration on cognitive performance was assessed by the paced auditory serial addition test (PASAT) at the baseline and after the 3- and 6-week intake of Ustukhuddus Alavi or placebo and the one-month follow-up in 86 healthy female high school students in grades 10 and 11. Additionally, we measured the levels of salivary cortisol of the students pre- and post-intervention.
RESULTS


Significant mean difference between the Ustukhuddus Alavi and placebo groups in three of the paced auditory serial addition test (PASAT) subscales, namely mental health (p-value = 0.006), sustained attention (p-value = 0.001) and mental fatigue (p-value = 0.001), were observed after six weeks. We also found a significant difference between the mean salivary cortisol level of the two groups after the intervention (p-value = 0.047).
CONCLUSIONS


These findings reveal that the intake of the multi-ingredient herbal product Ustukhuddus Alavi for six weeks can be helpful for cognitive function and cortisol levels in female high school students. These positive effects seem to be related to the increase in sustained attention and the decrease in mental fatigue.",2022,"We also found a significant difference between the mean salivary cortisol level of the two groups after the intervention (p-value = 0.047).
","['female high school students', 'adolescent female students', '86 healthy female high school students in grades 10 and 11', 'high school students']","['placebo', 'Ustukhuddus Alavi', 'Ustukhuddus Alavi or placebo', 'Ustukhuddus Alavi versus placebo', 'multi-component herbal product']","['cognitive performance', 'paced auditory serial addition test (PASAT) subscales, namely mental health', 'cognitive function and cortisol levels', 'cognitive performance and salivary cortisol levels', 'levels of salivary cortisol', 'sustained attention', 'mental fatigue', 'paced auditory serial addition test (PASAT', 'mean salivary cortisol level']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}]","[{'cui': 'C0589060', 'cui_str': 'Paced auditory serial addition test'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",86.0,0.082872,"We also found a significant difference between the mean salivary cortisol level of the two groups after the intervention (p-value = 0.047).
","[{'ForeName': 'Samane', 'Initials': 'S', 'LastName': 'Tefagh', 'Affiliation': 'Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Mokaberinejad', 'Affiliation': 'Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: mokaberi@sbmu.ac.ir.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Shakiba', 'Affiliation': 'Pediatric Department, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Jafari', 'Affiliation': 'Department of Clinical Psychology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Khayatkashani', 'Affiliation': 'Amol University of Special Modern Technologies, Amol, Iran.'}, {'ForeName': 'Nezhat', 'Initials': 'N', 'LastName': 'Shakeri', 'Affiliation': 'Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2022.114971']
3471,34999286,"Comment on ""Effectiveness of local anesthetic application methods in postoperative pain control in laparoscopic cholecystectomies; a randomised controlled trial"".",,2022,,['laparoscopic cholecystectomies'],['local anesthetic application methods'],['postoperative pain control'],"[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.247063,,"[{'ForeName': 'Lingna', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Center for Geriatrics, The Affiliated Hospital of Medical College of Ningbo University, Ningbo, 315000, Zhejiang, China. Electronic address: lingnadongnb@sohu.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2021.106211']
3472,35013089,Results of the Kigali Imbereheza Project: A 2-arm individually randomized trial of TI-CBT enhanced to address ART adherence and mental health for Rwandan youth living with HIV.,"BACKGROUND


Adolescents living with HIV have elevated mental distress and suboptimal ART adherence.
SETTING


Two urban clinics in Kigali, Rwanda.
METHODS


A 2-arm individual randomized controlled trial compared Trauma Informed Cognitive Behavioral Therapy enhanced to address HIV (TI-CBTe) to usual care (time-matched, long-standing, unstructured support groups) with 356 12-21 year-old (M=16.78) Rwandans living with HIV. TI-CBTe included six group-based 2-hour sessions led by trained and supervised 21-25 year old Rwandans living with HIV. Participants reported their ART adherence, depression/anxiety, and PTSD symptoms at baseline, 6-, 12-, and 18-months.
RESULTS


ART adherence was relatively high at baseline, and youth reported elevated rates of depression/anxiety and trauma symptoms. There was no differential treatment effects on adherence, but depression/anxiety improved over time. Youth with lower depression/anxiety at baseline appeared to benefit more from TI-CBTe than usual care, whereas females with high baseline distress appeared to benefit more from usual care. Youth were less likely to score in high PTSD symptom categories at follow-up, with no differential treatment effects.
CONCLUSIONS


TI-CBTe did not outperform usual care on ART adherence, possibly reflecting relatively high adherence at baseline, simplified medication regimens over time, a strong comparison condition, or because youth assigned to TI-CBTe returned to their support groups following the intervention. TI-CBTe was more effective for youth with lower depression/anxiety symptoms, whereas youth with high distress benefitted more from the support groups. TI-CBTe was feasible and acceptable, and young adults living with HIV were able to deliver a mental health intervention with fidelity. The powerful nature of the comparison group, ongoing support groups, points to the potential value of locally-crafted interventions in low resource settings.",2022,"TI-CBTe was feasible and acceptable, and young adults living with HIV were able to deliver a mental health intervention with fidelity.","['Adolescents living with HIV have elevated mental distress and suboptimal ART adherence', 'young adults living with HIV', '356 12-21 year-old (M=16.78) Rwandans living with HIV', 'Two urban clinics in Kigali, Rwanda.\nMETHODS', 'Rwandan youth living with HIV']","['Kigali Imbereheza Project', 'TI-CBT', 'Trauma Informed Cognitive Behavioral Therapy']","['ART adherence and mental health', 'ART adherence', 'ART adherence, depression/anxiety, and PTSD symptoms', 'adherence, but depression/anxiety']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0235109', 'cui_str': 'Mental distress'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0700287', 'cui_str': 'Informing'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0650313,"TI-CBTe was feasible and acceptable, and young adults living with HIV were able to deliver a mental health intervention with fidelity.","[{'ForeName': 'Geri R', 'Initials': 'GR', 'LastName': 'Donenberg', 'Affiliation': ""Center for Dissemination and Implementation Science, Department of Medicine, University of Illinois at Chicago, Chicago, IL USA Department of Medicine, University of Illinois at Chicago Women's Equity in Access to Care and Treatment (WE-ACTx), San Francisco, California, US Department of Medicine, Stroger Hospital of Cook County, Chicago IL USA WE-ACTx for Hope Clinic (WFH), Kigali, Rwanda Rwandan Biomedical Center, Kigali, Rwanda University Teaching Hospital of Kigali (CHUK), Department of Medicine, Kigali, Rwanda.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Fitts', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ingabire', 'Affiliation': ''}, {'ForeName': 'Sabin', 'Initials': 'S', 'LastName': 'Nsanzimana', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fabri', 'Affiliation': ''}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Emerson', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Remera', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Manzi', 'Affiliation': ''}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Bray', 'Affiliation': ''}, {'ForeName': 'Mardge H', 'Initials': 'MH', 'LastName': 'Cohen', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002911']
3473,35240010,CT or Invasive Coronary Angiography in Stable Chest Pain.,"BACKGROUND


In the diagnosis of obstructive coronary artery disease (CAD), computed tomography (CT) is an accurate, noninvasive alternative to invasive coronary angiography (ICA). However, the comparative effectiveness of CT and ICA in the management of CAD to reduce the frequency of major adverse cardiovascular events is uncertain.
METHODS


We conducted a pragmatic, randomized trial comparing CT with ICA as initial diagnostic imaging strategies for guiding the treatment of patients with stable chest pain who had an intermediate pretest probability of obstructive CAD and were referred for ICA at one of 26 European centers. The primary outcome was major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) over 3.5 years. Key secondary outcomes were procedure-related complications and angina pectoris.
RESULTS


Among 3561 patients (56.2% of whom were women), follow-up was complete for 3523 (98.9%). Major adverse cardiovascular events occurred in 38 of 1808 patients (2.1%) in the CT group and in 52 of 1753 (3.0%) in the ICA group (hazard ratio, 0.70; 95% confidence interval [CI], 0.46 to 1.07; P = 0.10). Major procedure-related complications occurred in 9 patients (0.5%) in the CT group and in 33 (1.9%) in the ICA group (hazard ratio, 0.26; 95% CI, 0.13 to 0.55). Angina during the final 4 weeks of follow-up was reported in 8.8% of the patients in the CT group and in 7.5% of those in the ICA group (odds ratio, 1.17; 95% CI, 0.92 to 1.48).
CONCLUSIONS


Among patients referred for ICA because of stable chest pain and intermediate pretest probability of CAD, the risk of major adverse cardiovascular events was similar in the CT group and the ICA group. The frequency of major procedure-related complications was lower with an initial CT strategy. (Funded by the European Union Seventh Framework Program and others; DISCHARGE ClinicalTrials.gov number, NCT02400229.).",2022,"Major adverse cardiovascular events occurred in 38 of 1808 patients (2.1%) in the CT group and in 52 of 1753 (3.0%) in the ICA group (hazard ratio, 0.70; 95% confidence interval [CI], 0.46 to 1.07; P = 0.10).","['patients with stable chest pain who had an intermediate pretest probability of obstructive CAD and were referred for ICA at one of 26 European centers', '3561 patients (56.2% of whom were women', 'Stable Chest Pain']","['CT', 'CT with ICA', 'CT or Invasive Coronary Angiography', 'computed tomography (CT', 'CT and ICA']","['Major procedure-related complications', 'Major adverse cardiovascular events', 'procedure-related complications and angina pectoris', 'major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke', 'frequency of major procedure-related complications', 'risk of major adverse cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",3561.0,0.0747648,"Major adverse cardiovascular events occurred in 38 of 1808 patients (2.1%) in the CT group and in 52 of 1753 (3.0%) in the ICA group (hazard ratio, 0.70; 95% confidence interval [CI], 0.46 to 1.07; P = 0.10).","[{'ForeName': 'Pál', 'Initials': 'P', 'LastName': 'Maurovich-Horvat', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bosserdt', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Kofoed', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rieckmann', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Benedek', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Donnelly', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Rodriguez-Palomares', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Štěchovský', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Gintare', 'Initials': 'G', 'LastName': 'Šakalyte', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Čemerlić Adić', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Gutberlet', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Dodd', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Diez', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Gershan', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Zimmermann', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Kępka', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Radosav', 'Initials': 'R', 'LastName': 'Vidakovic', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Francone', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Ilnicka-Suckiel', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Plank', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Juhani', 'Initials': 'J', 'LastName': 'Knuuti', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Faria', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Schröder', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Saba', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Ruzsics', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Kubiak', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Gutierrez-Ibarluzea', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Schultz Hansen', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Müller-Nordhorn', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Andreas D', 'Initials': 'AD', 'LastName': 'Knudsen', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Benedek', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Orr', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Xavier Valente', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Ligita', 'Initials': 'L', 'LastName': 'Zvaigzne', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Vojtěch', 'Initials': 'V', 'LastName': 'Suchánek', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zajančkauskiene', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Adić', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Woinke', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hensey', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Lecumberri', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Thwaite', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Laule', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Kruk', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Aleksandar N', 'Initials': 'AN', 'LastName': 'Neskovic', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Mancone', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Donata', 'Initials': 'D', 'LastName': 'Kuśmierz', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Feuchtner', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Pietilä', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Vasco', 'Initials': 'V', 'LastName': 'Gama Ribeiro', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Drosch', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Delles', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Gildo', 'Initials': 'G', 'LastName': 'Matta', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Bálint', 'Initials': 'B', 'LastName': 'Szilveszter', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Larsen', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Ratiu', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Garcia Del Blanco', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Ainhoa', 'Initials': 'A', 'LastName': 'Rubio', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Zsófia D', 'Initials': 'ZD', 'LastName': 'Drobni', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Jurlander', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Rodean', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Hug', 'Initials': 'H', 'LastName': 'Cuéllar Calabria', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Boussoussou', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Hodas', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Adriane E', 'Initials': 'AE', 'LastName': 'Napp', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Haase', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Feger', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Lina M', 'Initials': 'LM', 'LastName': 'Serna-Higuita', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Neumann', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Henryk', 'Initials': 'H', 'LastName': 'Dreger', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Rief', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Wieske', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Estrella', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dewey', 'Affiliation': ""The authors' affiliations are as follows: the Heart and Vascular Center (P.M.-H., B.M., B.S., Z.D.D., M. Boussoussou) and the Department of Radiology, Medical Imaging Center (P.M.-H.), Semmelweis University, Budapest, Hungary; the Departments of Radiology (M. Bosserdt, E.Z., A.E.N., R. Haase, S.F., M. Rief, V.W., M.E., M.D.) and Cardiology and Angiology (M.L., H.D.), the Institute of Public Health (N.R., J.M.-N.), and the Institute of Biometry and Clinical Epidemiology (K.N.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin and DZHK (German Center for Cardiovascular Research) Partner Site Berlin (H.D., M.D.), Berlin Institute of Health and Berlin University Alliance (M.D.), Berlin, the Departments of Radiology (M.G.) and Cardiology (M.W.), University of Leipzig Heart Center, Leipzig, the Department of Cardiology, Alb Fils Kliniken, Göppingen (S.S., T.D.), the Bavarian Cancer Registry, Bavarian Health and Food Safety Authority, Munich (J.M.-N.), and the Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen (L.M.S.-H., P.M.) - all in Germany; the Departments of Cardiology (K.F.K., A.D.K., T.E.) and Radiology (K.F.K., A.D.K.), Rigshospitalet, and the Department of Clinical Medicine, Faculty of Health and Medical Sciences (K.F.K., A.D.K., T.E., L.L., B.J.), and the Department of Public Health, Section for Health Services Research (K.S.H.), University of Copenhagen, Copenhagen, the Department of Cardiology, Herlev-Gentofte Hospital, Hellerup (L.L.), and the Department of Cardiology, Nordsjaellands Hospital, Hillerod (B.J.) - all in Denmark; the Department of Internal Medicine, Clinic of Cardiology (T.B., R. Hodas), and the Department of Radiology and Medical Imaging (M. Ratiu), George Emil Palade University of Medicine, Pharmacy, Science, and Technology, County Clinical Emergency Hospital Targu Mures (T.B.), and the Center of Advanced Research in Multimodality Cardiac Imaging, CardioMed Medical Center (I.B., I.R.) - all in Targu Mures, Romania; the Department of Cardiology, Southeastern Health and Social Care Trust, Belfast (P.D., C.O., S.K., S.R.), the Departments of Cardiology (G.D.) and Radiology (E.T.), Aintree University Hospital, the Department of Cardiology, Royal Liverpool University Hospital and the Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital (B.R., M. Fisher), and the Faculty of Health and Life Sciences, University of Liverpool (M. Fisher), Liverpool, Edge Hill University,\xa0Ormskirk (G.D.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (C.B., C.D.), and Golden Jubilee National Hospital, Clydebank (C.B.) - all in the United Kingdom; the Departments of Cardiology (J.R.-P., F.X.V., B.G.B.) and Radiology (H.C.C.), Hospital Universitario Vall d'Hebron, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Centro de Investigación Biomédica en Red, Madrid (J.R.-P., F.X.V., B.G.B.), the Departments of Cardiology (I.D., A.R.) and Radiology (I.L.), Basurto Hospital, Bilbao, Basque Foundation for Health Innovation and Research, Barakaldo, and the Basque Office for Health Technology Assessment, Vitoria-Gasteiz (I.G.-I.) - all in Spain; the Departments of Cardiology (A.E.) and Radiology (L. Zvaigzne), Paul Stradins Clinical University Hospital, and the University of Latvia (A.E.) - both in Riga, Latvia; the Departments of Cardiology (C.Š.) and Imaging Methods (V.S.), Motol University Hospital, Prague, Czech Republic; the Department of Cardiology, Medical Academy, Lithuanian University of Health Sciences, and the Department of Cardiology, Hospital of Lithuanian University of Health Sciences (G.Š., L. Zajančkauskiene) - both in Kaunas, Lithuania; the Faculty of Medicine, University of Novi Sad, and the Department of Cardiology, Institute for Cardiovascular Diseases of Vojvodina, Novi Sad (N.Č.A., F.A.), and the Department of Cardiology, Internal Medicine Clinic, Clinical Hospital Center Zemun, and the Faculty of Medicine, University of Belgrade, Belgrade (R.V., A.N.N.) - all in Serbia; the Departments of Radiology (J.D.D.) and Cardiology (M.H.), St. Vincent's University Hospital and School of Medicine, University College Dublin (J.D.D.), Dublin; the National Institute of Cardiology, Warsaw (C. Kępka, M.K.), and the Departments of Cardiology (M.I.-S.) and Radiology (D.K.), Provincial Specialist Hospital in Wroclaw, Wroclaw - both in Poland; the Department of Clinical Internal, Anesthesiologic, and Cardiovascular Sciences, Sapienza University of Rome, Rome (M.M.), the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital (M. Francone), Milan, and the Department of Radiology, University of Cagliari (L.S.), and the Department of Radiology, Azienda Ospedaliera Brotzu (G.M.), Cagliari - all in Italy; the Department of Internal Medicine III, the Department of Cardiology (F.P.), and the Department of Radiology (G.F.), Innsbruck Medical University, Innsbruck, Austria; the Turku PET Center (J.K.) and Heart Center (M.P.), Turku University Hospital and University of Turku, and the Administrative Center, Health Care District of Southwestern Finland (M.P.) - all in Turku, Finland; the Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia-Espinho, Vila Nova de Gaia, Portugal (R.F., V.G.R.); and the European Clinical Research Infrastructure Network-European Research Infrastructure Consortium, Paris (C. Kubiak).""}]",The New England journal of medicine,['10.1056/NEJMoa2200963']
3474,35240345,An informative video before planned Cesarean-delivery and maternal anxiety-a multicenter randomized controlled trial.,"BACKGROUND


Cesarean delivery (CD) is one of the most common procedures performed in obstetrics, and although CD is a blissful occasion, it is commonly associated with fear and anxiety for the new mother.
OBJECTIVE


We aimed to study the impact of watching a detailed, informative video on maternal anxiety levels, childbirth experience, and patient satisfaction - in patients undergoing a primary CD.
STUDY DESIGN


We performed a multicenter randomized control trial. Patients scheduled to undergo a primary non-emergent CD were recruited. All patients in the intervention group watched an informative video upon recruitment. This 4-minute video described in detail the expected CD process: preparations before entering the operation room, regional anesthesia administration, sterile covering, the surgical procedure itself, and recovery (including mobilization and lactation). Situation-specific anxiety was measured at recruitment, before exposure to the video (S1), at the day of operation (S2), and at postpartum day 1 (S3) using the State-Trait Anxiety Inventory (STAI) score. Additionally, patients answered 10- item Childbirth Experience Questionnaire. A sample size of 63 per group was planned to achieve 80% power to detect a difference of 5 points in the primary outcome (STAI score at the day of operation).
RESULTS


Overall, 154 patients from 4 medical centers were randomized, and 132 patients were analyzed after completing all questionnaires, 64 patients in the video group and 68 patients in the control group. The groups did not differ in demographics and delivery characteristics, as well as similar baseline anxiety levels (S1). On operation day (S2, the primary outcome), significantly lower anxiety levels were reported in the video group compared to the control group (STAI scores 41.3±9.5 vs. 49.3±10.3, p<0.001). Moreover, anxiety levels in postpartum day 1 (S3) remained significantly lower in the video group (p<0.001). No differences between the groups in childbirth experience score or patient satisfaction were demonstrated.
CONCLUSION


A detailed informative video prior to primary CD decreased maternal anxiety before and after the procedure.",2022,"On operation day (S2, the primary outcome), significantly lower anxiety levels were reported in the video group compared to the control group (STAI scores 41.3±9.5 vs. 49.3±10.3, p<0.001).","['Patients scheduled to undergo a primary non-emergent CD were recruited', 'patients undergoing a primary CD', '154 patients from 4 medical centers were randomized, and 132 patients were analyzed after completing all questionnaires, 64 patients in the video group and 68 patients in the control group']",[],"['baseline anxiety levels (S1', 'anxiety levels', 'maternal anxiety', 'Situation-specific anxiety', 'lower anxiety levels', 'State-Trait Anxiety Inventory (STAI) score', 'childbirth experience score or patient satisfaction']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",154.0,0.141789,"On operation day (S2, the primary outcome), significantly lower anxiety levels were reported in the video group compared to the control group (STAI scores 41.3±9.5 vs. 49.3±10.3, p<0.001).","[{'ForeName': 'Hadas', 'Initials': 'H', 'LastName': 'Miremberg', 'Affiliation': 'Department of Obstetrics and Gynecology, the Edith Wolfson Medical Center, Holon, Israel; Affiliated with Sackler School of Medicine, Tel-Aviv University, Israel.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Yirmiya', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Israel; Interdisciplinary Center, Herzliya, Israel.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Vinter', 'Affiliation': 'Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel; Affiliated with Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Lauterbach', 'Affiliation': 'Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel; Affiliated with Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Enav', 'Initials': 'E', 'LastName': 'Yefet', 'Affiliation': 'Department of Obstetrics and Gynecology, Baruch Padeh Medical Center Poriya, Tiberias, Israel; Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Nassra', 'Affiliation': 'Department of Obstetrics and Gynecology, Baruch Padeh Medical Center Poriya, Tiberias, Israel.'}, {'ForeName': 'Yael Ganor', 'Initials': 'YG', 'LastName': 'Paz', 'Affiliation': ""Department of Obstetrics and Gynecology, the Edith Wolfson Medical Center, Holon, Israel; Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod, Israel; Faculty of Health sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel.""}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hagege', 'Affiliation': 'Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod, Israel.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Weiner', 'Affiliation': 'Department of Obstetrics and Gynecology, the Edith Wolfson Medical Center, Holon, Israel; Affiliated with Sackler School of Medicine, Tel-Aviv University, Israel.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100604']
3475,35015817,Early Trajectory of Estimated Glomerular Filtration Rate and Long-term Advanced Kidney and Cardiovascular Complications in Type 1 Diabetes.,"OBJECTIVE


Rapid loss of estimated glomerular filtration rate (eGFR) within its normal range has been proposed as a strong predictor of future kidney disease. We investigated this association of eGFR slope early in the course of type 1 diabetes with long-term incidence of kidney and cardiovascular complications.
RESEARCH DESIGN AND METHODS


The annual percentage change in eGFR (slope) was calculated during the Diabetes Control and Complications Trial (DCCT) for each of 1,441 participants over a mean of 6.5 years and dichotomized by the presence or absence of early rapid eGFR loss (slope ≤-3% per year) as the exposure of interest. Outcomes were incident reduced eGFR (eGFR <60 mL/min/1.73 m2), composite cardiovascular events, or major adverse cardiovascular events (MACE) during the subsequent 24 years post-DCCT closeout follow-up.
RESULTS


At DCCT closeout (the baseline for this analysis), diabetes duration was 12 ± 4.8 years, most participants (85.9%) had normoalbuminuria, mean eGFR was 117.0 ± 13.4 mL/min/1.73 m2, and 149 (10.4%) had experienced early rapid eGFR loss over the preceding trial phase. Over the 24-year subsequent follow-up, there were 187 reduced eGFR (6.3 per 1,000 person-years) and 113 MACE (3.6 per 1,000 person-years) events. Early rapid eGFR loss was associated with risk of reduced eGFR (hazard ratio [HR] 1.81, 95% CI 1.18-2.79, P = 0.0064), but not after adjustment for baseline eGFR level (HR 0.94, 95% CI 0.53-1.66, P = 0.84). There was no association with composite cardiovascular events or MACE.
CONCLUSIONS


In people with type 1 diabetes primarily with normal eGFR and normoalbuminuria, the preceding slope of eGFR confers no additional association with kidney or cardiovascular outcomes beyond knowledge of an individual's current level.",2022,"Outcomes were incident reduced eGFR (eGFR <60 mL/min/1.73 m2), composite cardiovascular events, or major adverse cardiovascular events (MACE) during the subsequent 24 years post-DCCT closeout follow-up.
","['people with type 1 diabetes primarily with normal eGFR and normoalbuminuria', 'Type 1 Diabetes']",[],"['composite cardiovascular events, or major adverse cardiovascular events (MACE', 'Early rapid eGFR loss', 'baseline eGFR level', 'early rapid eGFR loss', 'diabetes duration']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]",[],"[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0793979,"Outcomes were incident reduced eGFR (eGFR <60 mL/min/1.73 m2), composite cardiovascular events, or major adverse cardiovascular events (MACE) during the subsequent 24 years post-DCCT closeout follow-up.
","[{'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Perkins', 'Affiliation': 'Department of Endocrinology and Metabolism, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ionut', 'Initials': 'I', 'LastName': 'Bebu', 'Affiliation': 'The Biostatistics Center, Milken Institute School of Public Health, The George Washington University, Washington, DC.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'The George Washington University, Washington, DC.'}, {'ForeName': 'Amy B', 'Initials': 'AB', 'LastName': 'Karger', 'Affiliation': 'University of Minnesota Twin Cities, Twin Cities, MN.'}, {'ForeName': 'Irl B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'Division of Metabolism, Endocrinology, and Nutrition, Department of Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Karanchi', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Molitch', 'Affiliation': 'Endocrinology, Metabolism and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Departments of Endocrinology and Metabolism, Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Lachin', 'Affiliation': 'The Biostatistics Center, Milken Institute School of Public Health, The George Washington University, Washington, DC.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'Division of Metabolism, Endocrinology, and Nutrition, Department of Medicine, University of Washington, Seattle, WA.'}]",Diabetes care,['10.2337/dc21-1883']
3476,35017400,Optimising working space for laparoscopic pyeloplasty in infants: Preliminary observations with the SGPGI Protocol.,"Aims


This study aimed to test the efficacy of SGPGI protocol to minimise bowel distension and optimise working space for laparoscopic pyeloplasty in infants.
Methodology


All infants who underwent laparoscopic pyeloplasty for unilateral pelvi-ureteric junction obstruction (PUJO) between January 2017 and March 2020 were included in the study. The patient cohort was divided into two groups: Group A and B. Group A included patients who underwent routine pre-operative preparation. Group B included patients wherein the SGPGI protocol was used. The key features of the protocol were fasting for 8 h, enemas, inserting a nasogastric tube in the pre-operative period and decompressing the colon on the operation table. Demographic features, pre-operative, intraoperative and post-operative parameters were compared between the two groups.
Results


A total of 26 infants with unilateral PUJO underwent laparoscopic pyeloplasty during the study period. Group A included 12 patients and Group B included 14 patients. Both the groups were similar in age, weight and sex distribution. The median surgeon's rating score for suturing conditions was 2 for Group A and 5 for Group B patients (P > 0.05). The operating time was significantly longer in Group A (196 ± 21 min) as compared to Group B (114 ± 18 min) (P < 0.05). In Group A, intra-abdominal pressure (IAP) varied between 9 and 14 mmHg (median 12 mmHg), while in Group B, IAP varied between 6 and 9 mmHg (median 8 mmHg) (P < 0.05). In Group A, in 2/12 cases (16.7%), conversion to an open procedure was necessary because of inadequate working space owing to gross intestinal distension. Two patients in Group A also had intraoperative injuries to adjacent structures due to poor working space.
Conclusions


Optimal working space is critical to the performance of advanced laparoscopic surgery like pyeloplasty in infants. SGPGI protocol significantly improves working space, which permits a faster and safer surgery with a lower intra-abdominal working pressure. This protocol is simple, safe and easy to replicate at most centres in our country.",2022,"SGPGI protocol significantly improves working space, which permits a faster and safer surgery with a lower intra-abdominal working pressure.","['for unilateral pelvi-ureteric junction obstruction (PUJO) between January 2017 and March 2020 were included in the study', 'advanced laparoscopic surgery like pyeloplasty in infants', '26 infants with unilateral PUJO underwent', '12 patients and Group B included 14 patients', 'infants']","['SGPGI protocol', 'laparoscopic pyeloplasty', 'routine pre-operative preparation']","[""median surgeon's rating score for suturing conditions"", 'intra-abdominal pressure (IAP', 'working space', 'operating time']","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0521619', 'cui_str': 'Obstruction of pelviureteric junction'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0554139', 'cui_str': 'Pyeloplasty'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0812509', 'cui_str': 'Laparoscopic pyeloplasty'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",26.0,0.0265636,"SGPGI protocol significantly improves working space, which permits a faster and safer surgery with a lower intra-abdominal working pressure.","[{'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Mandelia', 'Affiliation': 'Department of Pediatric Surgery, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Rudrashish', 'Initials': 'R', 'LastName': 'Haldar', 'Affiliation': 'Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Yousuf', 'Initials': 'Y', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Pediatric Surgery, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Ashwani', 'Initials': 'A', 'LastName': 'Mishra', 'Affiliation': 'Department of Pediatric Surgery, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_202_20']
3477,35022501,Dengue surveillance using gravid oviposition sticky (GOS) trap and dengue non-structural 1 (NS1) antigen test in Malaysia: randomized controlled trial.,"Dengue remains a major public threat and existing dengue control/surveillance programs lack sensitivity and proactivity. More efficient methods are needed. A cluster randomized controlled trial was conducted for 18 months to determine the efficacy of using a combination of gravid oviposition sticky (GOS) traps and dengue non-structural 1 (NS1) antigen for early surveillance of dengue among Aedes mosquito. Eight residential apartments were randomly assigned into intervention and control groups. GOS traps were placed at the intervention apartments weekly to trap Aedes mosquitoes and these tested for dengue NS1 antigen. When dengue-positive pool was detected, the community were notified and advised to execute protective measures. Fewer dengue cases were recorded in the intervention group than the control. Detection of NS1-positive mosquitoes was significantly associated with GOS Aedes index (r s  = 0.68, P < 0.01) and occurrence of dengue cases (r s  = 0.31, P < 0.01). Participants' knowledge, attitude, and practice (KAP) toward dengue control indicated significant improvement for knowledge (P < 0.01), practice (P < 0.01) and total scores (P < 0.01). Most respondents thought this surveillance method is good (81.2%) and supported its use nationwide. Thus, GOS trap and dengue NS1 antigen test can supplement the current dengue surveillance/control, in alignment with the advocated integrated vector management for reducing Aedes-borne diseases.",2022,"Participants' knowledge, attitude, and practice (KAP) toward dengue control indicated significant improvement for knowledge (P < 0.01), practice (P < 0.01) and total scores (P < 0.01).","['Malaysia', 'early surveillance of dengue among Aedes mosquito', 'Eight residential apartments']","['gravid oviposition sticky (GOS) traps and dengue non-structural 1 (NS1) antigen', 'gravid oviposition sticky (GOS) trap and dengue non-structural 1 (NS1) antigen test']","['total scores', 'GOS Aedes index', 'knowledge']","[{'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0001692', 'cui_str': 'Aedes'}, {'cui': 'C0026584', 'cui_str': 'Family Culicidae'}, {'cui': 'C0457933', 'cui_str': 'Apartment'}]","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0029957', 'cui_str': 'Oviposition'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0729856', 'cui_str': 'Antigen test'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0029957', 'cui_str': 'Oviposition'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0464226,"Participants' knowledge, attitude, and practice (KAP) toward dengue control indicated significant improvement for knowledge (P < 0.01), practice (P < 0.01) and total scores (P < 0.01).","[{'ForeName': 'Sivaneswari', 'Initials': 'S', 'LastName': 'Selvarajoo', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universiti Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Jonathan Wee Kent', 'Initials': 'JWK', 'LastName': 'Liew', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universiti Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Tock H', 'Initials': 'TH', 'LastName': 'Chua', 'Affiliation': 'Department of Pathobiology and Medical Diagnostics, Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah, 88400, Kota Kinabalu, Sabah, Malaysia.'}, {'ForeName': 'Wing', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universiti Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Rafdzah Ahmad', 'Initials': 'RA', 'LastName': 'Zaki', 'Affiliation': 'Department of Social and Preventive Medicine, Faculty of Medicine, Centre for Epidemiology and Evidence Based Practice, Universiti Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Romano', 'Initials': 'R', 'LastName': 'Ngui', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universiti Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Wan Yusoff Wan', 'Initials': 'WYW', 'LastName': 'Sulaiman', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universiti Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Poo Soon', 'Initials': 'PS', 'LastName': 'Ong', 'Affiliation': 'Petaling Jaya City Council, 46675, Petaling Jaya, Selangor, Malaysia.'}, {'ForeName': 'Indra', 'Initials': 'I', 'LastName': 'Vythilingam', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universiti Malaya, 50603, Kuala Lumpur, Malaysia. indrav@um.edu.my.'}]",Scientific reports,['10.1038/s41598-021-04643-4']
3478,34975829,Integrative Transcriptomics Reveals Activation of Innate Immune Responses and Inhibition of Inflammation During Oral Immunotherapy for Egg Allergy in Children.,"We previously reported the results of a randomized, open-label trial of egg oral immunotherapy (OIT) in 50 children where 44% were desensitized and 46% were partially desensitized after 8 months of treatment. Here we focus on cell-mediated molecular mechanisms driving desensitization during egg OIT. We sought to determine whether changes in genome-wide gene expression in blood cells during egg OIT correlate with humoral responses and the clinical outcome. The blood cell transcriptome of 50 children receiving egg OIT was profiled using peripheral blood mononuclear cell (PBMC) samples obtained at baseline and after 3 and 8 months of OIT. We identified 467 differentially expressed genes (DEGs) after 3 or 8 months of egg OIT. At 8 months, 86% of the DEGs were downregulated and played a role in the signaling of TREM1, IL-6, and IL-17. In correlation analyses, Gal d 1-4-specific IgG4 antibodies associated positively with DEGs playing a role in pathogen recognition and antigen presentation and negatively with DEGs playing a role in the signaling of IL-10, IL-6, and IL-17. Desensitized and partially desensitized patients had differences in their antibody responses, and although most of the transcriptomic changes were shared, both groups had also specific patterns, which suggest slower changes in partially desensitized and activation of NK cells in the desensitized group. OIT for egg allergy in children inhibits inflammation and activates innate immune responses regardless of the clinical outcome at 8 months. Changes in gene expression patterns first appear as posttranslational protein modifications, followed by more sustained epigenetic gene regulatory functions related to successful desensitization.",2021,"At 8 months, 86% of the DEGs were downregulated and played a role in the signaling of TREM1, IL-6, and IL-17.","['50 children receiving egg OIT', '50 children where 44% were desensitized and 46% were partially desensitized after 8 months of treatment', 'Egg Allergy in Children']",['egg oral immunotherapy (OIT'],"['signaling of TREM1, IL-6, and IL-17', 'blood cell transcriptome']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0559469', 'cui_str': 'Allergy to edible egg'}]","[{'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0005773', 'cui_str': 'Blood cell'}, {'cui': 'C3178810', 'cui_str': 'Transcriptomes'}]",50.0,0.154723,"At 8 months, 86% of the DEGs were downregulated and played a role in the signaling of TREM1, IL-6, and IL-17.","[{'ForeName': 'Piia', 'Initials': 'P', 'LastName': 'Karisola', 'Affiliation': 'Human Microbiome (HUMI) Research Program, Medical Faculty, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Palosuo', 'Affiliation': 'Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hinkkanen', 'Affiliation': 'Human Microbiome (HUMI) Research Program, Medical Faculty, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Wisgrill', 'Affiliation': 'Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Savinko', 'Affiliation': 'Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Fyhrquist', 'Affiliation': 'Human Microbiome (HUMI) Research Program, Medical Faculty, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Alenius', 'Affiliation': 'Human Microbiome (HUMI) Research Program, Medical Faculty, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Mika J', 'Initials': 'MJ', 'LastName': 'Mäkelä', 'Affiliation': 'Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}]",Frontiers in immunology,['10.3389/fimmu.2021.704633']
3479,35022317,Fat-rich versus carbohydrate-rich nutrition in ALS: a randomised controlled study.,"OBJECTIVE


There is growing evidence that the course of amyotrophic lateral sclerosis (ALS) may be influenced beneficially by applying high-caloric food supplements (HCSs). However, it is unknown which composition of nutrients offers optimal tolerability and weight gain.
METHODS


We conducted a randomised controlled study (Safety and Tolerability of Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS); TOLCAL-ALS study) in 64 patients with possible, probable or definite ALS according to El Escorial criteria. Patients were randomised into four groups: a high-caloric fatty supplement (HCFS; 405 kcal/day, 100% fat), an ultra-high-caloric fatty supplement (UHCFS; 810 kcal/day, 100% fat), an ultra-high-caloric, carbohydrate-rich supplement (UHCCS; 900 kcal/day, 49% carbohydrates) and an open control (OC) group without any supplement. The primary endpoint was tolerability. Patients were followed up over 4 weeks.
RESULTS


Gastrointestinal side effects were most frequent in the UHCFS group (75.0%), while loss of appetite was most frequent in the UHCCS group (35.3%). During intervention, patients gained +0.9 kg/month of body weight (IQR -0.9 to 1.5; p=0.03) in the HCFS group and +0.9 kg/month (IQR -0.8 to 2.0; p=0.05) in the UHCFS group. A non-significant trend for weight gain (+0.6 kg/month (IQR -0.3 to 1.9; p=0.08)) was observed in the UHCCS group. Patients in OC group continued to lose body weight (-0.5 kg/month, IQR -1.4 to 1.3; p=0.42).
INTERPRETATION


The findings suggest that HCSs frequently cause mild to moderate tolerability issues in patients with ALS, most notably gastrointestinal symptoms in high-fat supplements, and loss of appetite in high-carbohydrate supplements. All three HCSs tested are suited to increase body weight.",2022,A non-significant trend for weight gain (+0.6 kg/month (IQR -0.3 to 1.9; p=0.08)) was observed in the UHCCS group.,"['Amyotrophic Lateral Sclerosis (ALS', 'ALS', 'patients with ALS', '64 patients with possible, probable or definite ALS according to El Escorial criteria']","['UHCFS', 'HCFS', 'Fat-rich versus carbohydrate-rich nutrition', 'UHCCS', 'high-caloric fatty supplement (HCFS; 405 kcal/day, 100% fat), an ultra-high-caloric fatty supplement (UHCFS; 810 kcal/day, 100% fat), an ultra-high-caloric, carbohydrate-rich supplement (UHCCS; 900 kcal/day, 49% carbohydrates) and an open control (OC) group without any supplement', 'Ultra-high-caloric Food Supplements']","['weight gain', 'loss of appetite', 'tolerability', 'Gastrointestinal side effects', 'body weight']","[{'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",64.0,0.0223428,A non-significant trend for weight gain (+0.6 kg/month (IQR -0.3 to 1.9; p=0.08)) was observed in the UHCCS group.,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Dorst', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Baden-Württemberg, Germany Dorst_2001@yahoo.de.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Doenz', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kandler', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Dreyhaupt', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Hayrettin', 'Initials': 'H', 'LastName': 'Tumani', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Witzel', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Schuster', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'Ludolph', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Baden-Württemberg, Germany.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2021-328331']
3480,35024876,[Prophylactic cranial irradiation with or without hippocampal avoidance for small-cell lung cancer (PREMER)- a randomized phase III trial].,,2022,,['small-cell lung cancer'],['Prophylactic cranial irradiation with or without hippocampal avoidance'],[],"[{'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0079172', 'cui_str': 'Cranial Irradiation'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}]",[],,0.319643,,"[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Schunn', 'Affiliation': 'Radiologische Klinik | Klinik für RadioOnkologie und Strahlentherapie, Universitätsklinikum Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Deutschland. Fabian.Schunn@med.uni-heidelberg.de.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Koerber', 'Affiliation': 'Radiologische Klinik | Klinik für RadioOnkologie und Strahlentherapie, Universitätsklinikum Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Deutschland.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-021-01899-7']
3481,35017102,Symptoms Experienced at the Acute Phase of SARS-CoV-2 Infection as Risk Factor of Long-term Post-COVID Symptoms: The LONG-COVID-EXP-CM Multicenter Study.,"OBJECTIVE


This multicenter study investigated clinical risk factors associated with the number of long-term symptoms after COVID.
METHODS


Clinical features, symptoms at hospital admission, hospitalization data, and the number of symptoms after COVID was systematically assessed for patients who recovered from COVID-19 in 4 hospitals in Madrid (Spain) from February 20 to May 31, 2020.
RESULTS


Overall, 1,969 patients (46.5% women, age: 61, SD: 16 years) were randomly assessed 8.4 months (SD 1.5) after hospital discharge. Female gender (odds ratio [OR] 1.82, 95% confidence interval [CI] 1.57-2.10), number of morbidities (OR 1.182, 95% CI 1.08-1.29), number of symptoms at hospital admission (OR 1.309, 95% CI 1.15-1.49) and days at the hospital (OR 1.01, 95% CI 1.007-1.017) were associated (all, p <0.001) with more long-term symptoms after COVID. Further, vomiting (OR 1.78, 95% CI 1.26-2.52), throat pain (OR 1.36, 95% CI 1.02-1.81), diarrhea (OR 1.51, 95% CI 1.25-1.82), dyspnea (OR 1.20, 95% CI 1.01-1.41), or headache (OR 1.50, 95% CI 1.28-1.75) as symptoms at hospital admission were also associated (all, p <0.01) with a higher number of symptoms after COVID.
CONCLUSION


This multicenter study found that a higher number of symptoms at hospital admission were the most relevant risk factor for developing more symptoms after COVID, supporting the assumption that a higher symptom load at the acute phase is associated with a greater likelihood of long-term symptoms after COVID.",2022,"Further, vomiting (OR1.78, 95%CI 1.26-2.52), throat pain (OR1.36, 95%CI 1.02-1.81), diarrhoea (OR1.51, 95%CI 1.25-1.82), dyspnea (OR1.20, 95%CI 1.01-1.41), or headache (OR1.50, 95%CI 1.28-1.75) as symptoms at hospital admission were also associated (all, P<0.01) with a higher number of post-COVID symptoms.
","['1,969 patients (46.5% women, age: 61, SD: 16 years', 'Clinical features, symptoms at hospital admission, hospitalization data, and the number of post-COVID symptoms was systematically assessed from patients recovered from COVID-19 at four hospitals in Madrid (Spain) from February 20 to May 31, 2020']",[],"['vomiting', 'number of symptoms at hospital admission', 'throat pain', 'headache', 'diarrhoea', 'dyspnea', 'number of morbidities', 'symptoms at hospital admission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0242429', 'cui_str': 'Pain in throat'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.177428,"Further, vomiting (OR1.78, 95%CI 1.26-2.52), throat pain (OR1.36, 95%CI 1.02-1.81), diarrhoea (OR1.51, 95%CI 1.25-1.82), dyspnea (OR1.20, 95%CI 1.01-1.41), or headache (OR1.50, 95%CI 1.28-1.75) as symptoms at hospital admission were also associated (all, P<0.01) with a higher number of post-COVID symptoms.
","[{'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos (URJC), Madrid. Spain;. Electronic address: cesar.fernandez@urjc.es.'}, {'ForeName': 'Oscar J', 'Initials': 'OJ', 'LastName': 'Pellicer-Valero', 'Affiliation': 'Intelligent Data Analysis Laboratory, Department of Electronic Engineering, ETSE (Engineering School), Universitat de València (UV), Valencia, Spain.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Navarro-Pardo', 'Affiliation': 'Department of Developmental and Educational Psychology, Universitat de València (UV), València, Spain.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Palacios-Ceña', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos (URJC), Madrid. Spain.'}, {'ForeName': 'Lidiane L', 'Initials': 'LL', 'LastName': 'Florencio', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos (URJC), Madrid. Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Guijarro', 'Affiliation': 'Department of Medicine, Universidad Rey Juan Carlos (URJC), Madrid. Spain; Department of Internal Medicine, Hospital Universitario Fundación Alcorcón, Madrid, Spain.'}, {'ForeName': 'José D', 'Initials': 'JD', 'LastName': 'Martín-Guerrero', 'Affiliation': 'Intelligent Data Analysis Laboratory, Department of Electronic Engineering, ETSE (Engineering School), Universitat de València (UV), Valencia, Spain.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2022.01.007']
3482,34972764,Serious game to promote socioemotional learning and mental health ( emoTIC ): a study protocol for randomised controlled trial.,"INTRODUCTION


The development of emotional competences may be a protective factor for mental health problems, promoting well-being at such a complex age as adolescence. Technologies may be used to carry out this empowerment because adolescents are attracted to them. The purpose of the study is to design a serious game based on the Mayer  et al 's emotional intelligence ability model and analyse the effectiveness of the  emoTIC  programme to develop emotional competences, well-being, mental health, and personal strengths immediately after completion and at 12 months.
METHODS AND ANALYSIS


The new version of  emoTIC  will be designed following the suggestions of the adolescents who participated in the pilot study and the results obtained from the statistical analysis. The participants will be 385 adolescents aged 11-16 years who will be randomly assigned to the control group and the experimental group. The experimental group will complete the  emoTIC  programme. The primary outcomes include emotional competences and subjective well-being. The secondary outcomes are self-esteem; general self-efficacy; personality; social and personal responsibility; school social climate; somatic complaints; depression, anxiety and stress symptoms; emotional and behavioural difficulties; suicidal behaviour; and subjective happiness. Data will be collected at three moments: baseline (T1), immediately post-intervention (T2) and 12-month follow-up (T3). The effectiveness of the programme will be analysed using different statistical packages.
ETHICS AND DISSEMINATION


The study has been approved by the Ethics Commission of the University of Valencia (H152865096049), and the standards of the Declaration of Helsinki to collect the data will be followed. Results will be disseminated across the scientific community.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT04414449).
TRIAL SPONSOR


University of Valencia. Principal investigator: Inmaculada Montoya-Castilla.",2021,The new version of  emoTIC  will be designed following the suggestions of the adolescents who participated in the pilot study and the results obtained from the statistical analysis.,['385 adolescents aged 11-16 years'],[],"['self-esteem; general self-efficacy; personality; social and personal responsibility; school social climate; somatic complaints; depression, anxiety and stress symptoms; emotional and behavioural difficulties; suicidal behaviour; and subjective happiness', 'emotional competences and subjective well-being']","[{'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",385.0,0.109231,The new version of  emoTIC  will be designed following the suggestions of the adolescents who participated in the pilot study and the results obtained from the statistical analysis.,"[{'ForeName': 'Usue', 'Initials': 'U', 'LastName': 'De la Barrera', 'Affiliation': 'Personalidad, Evaluación y Tratamientos Psicológicos, Facultad de Psicología y Logopedia, Universitat de València, Valencia, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Postigo-Zegarra', 'Affiliation': 'Departamento de Psicología, Facultad de Ciencias de la Salud, Universidad Europea de Valencia, Valencia, Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Mónaco', 'Affiliation': 'Personalidad, Evaluación y Tratamientos Psicológicos, Facultad de Psicología y Logopedia, Universitat de València, Valencia, Spain.'}, {'ForeName': 'José-Antonio', 'Initials': 'JA', 'LastName': 'Gil-Gómez', 'Affiliation': 'Instituto Universitario de Investigación en Automática e Informática Industrial, Universitat Politècnica de València, Valencia, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Montoya-Castilla', 'Affiliation': 'Personalidad, Evaluación y Tratamientos Psicológicos, Facultad de Psicología y Logopedia, Universitat de València, Valencia, Spain inmaculada.montoya@uv.es.'}]",BMJ open,['10.1136/bmjopen-2021-052491']
3483,34971671,Neurocognitive effects of a training program for poor face recognizers using shape and texture caricatures: A pilot investigation.,"Recent research suggested disproportional usage of shape information by people with poor face recognition, although texture information appears to be more important for familiar face recognition. Here, we tested a training program with faces that were selectively caricatured in either shape or texture parameters. Forty-eight young adults with poor face recognition skills (1 SD below the mean in at least 2/3 face processing tests: CFMT, GFMT, BFFT) were pseudo-randomly assigned to either one of two training groups or a control group (n = 16 each). Training comprised six sessions over three weeks. Per session, participants studied ten unfamiliar facial identities whose shape or texture characteristics were caricatured. Before and after training (or waiting in the control group), all participants completed EEG experiments on face learning and famous face recognition, and behavioral face processing tests. Results showed small but specific training-induced improvements: Whereas shape training improved face matching (training tasks, and to some extent GFMT), texture training elicited marked improvements in face learning (CFMT). Moreover, for the texture training group the N170 ERP was enhanced for novel faces post-training, suggesting training-induced changes in early markers of face processing. Although further research is necessary, this suggests that parameter-specific caricature training is a promising way to improve performance in people with poor face recognition skills.",2022,"Moreover, for the texture training group the N170 ERP was enhanced for novel faces post-training, suggesting training-induced changes in early markers of face processing.","['people with poor face recognition skills', 'poor face recognizers using shape and texture caricatures', 'Forty-eight young adults with poor face recognition skills (1 SD below the mean in at least 2/3 face processing tests: CFMT, GFMT, BFFT']","['training program', 'texture training', 'EEG experiments on face learning and famous face recognition, and behavioral face processing tests']","['Neurocognitive effects', 'face learning (CFMT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0376656', 'cui_str': 'Caricatures'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",48.0,0.00324577,"Moreover, for the texture training group the N170 ERP was enhanced for novel faces post-training, suggesting training-induced changes in early markers of face processing.","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Limbach', 'Affiliation': 'Department of General Psychology, Friedrich Schiller University of Jena, Jena, Germany; Faculty for Rehabilitation Sciences, TU Dortmund, Dortmund, Germany. Electronic address: katharina.limbach@tu-dortmund.de.'}, {'ForeName': 'Marlena L', 'Initials': 'ML', 'LastName': 'Itz', 'Affiliation': 'Department of General Psychology, Friedrich Schiller University of Jena, Jena, Germany; Department of Counseling and Clinical Intervention, Friedrich Schiller University of Jena, Jena, Germany.'}, {'ForeName': 'Stefan R', 'Initials': 'SR', 'LastName': 'Schweinberger', 'Affiliation': 'Department of General Psychology, Friedrich Schiller University of Jena, Jena, Germany; Michael Stifel Center Jena for Data-Driven and Simulation Science, Friedrich Schiller University of Jena, Jena, Germany; DFG Research Unit Person Perception, Germany; Swiss Center for Affective Sciences, University of Geneva, Switzerland.'}, {'ForeName': 'Alexandra D', 'Initials': 'AD', 'LastName': 'Jentsch', 'Affiliation': 'Department of General Psychology, Friedrich Schiller University of Jena, Jena, Germany.'}, {'ForeName': 'Lidiia', 'Initials': 'L', 'LastName': 'Romanova', 'Affiliation': 'Department of General Psychology, Friedrich Schiller University of Jena, Jena, Germany.'}, {'ForeName': 'Jürgen M', 'Initials': 'JM', 'LastName': 'Kaufmann', 'Affiliation': 'Department of General Psychology, Friedrich Schiller University of Jena, Jena, Germany; DFG Research Unit Person Perception, Germany. Electronic address: juergen.kaufmann@uni-jena.de.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2021.108133']
3484,35027944,Effects of Neuromuscular Electrical Stimulation Combined with Repetitive Transcranial Magnetic Stimulation on Upper Limb Motor Function Rehabilitation in Stroke Patients with Hemiplegia.,"Objective


To investigate the effect of neuromuscular electrical stimulation (NMES) combined with repetitive transcranial magnetic stimulation (rTMS) on upper limb motor dysfunction in stroke patients with hemiplegia.
Methods


A total of 240 stroke patients with hemiplegia who met the inclusion criteria were selected and randomly divided into 4 groups (60 cases in each group): control group, NMES group, rTMS group, and NMES + rTMS group. Before treatment and 4 weeks after treatment, we evaluated and compared the results including Fugl-Meyer assessment of upper extremity (FMA-UE) motor function, modified Barthel index (MBI), modified Ashworth scale (MAS), and motor nerve electrophysiological results among the 4 groups.
Results


Before treatment, there was no significant difference in the scores of FMA-UE, MBI, MAS, and motor nerve electrophysiological indexes among the four groups, with comparability. Compared with those before treatment, the scores of the four groups were significantly increased and improved after treatment. And the score of the NMES + rTMS group was notably higher than those in the other three groups.
Conclusion


NMES combined with rTMS can conspicuously improve the upper extremity motor function and activities of daily life of stroke patients with hemiplegia, which is worthy of clinical application and promotion.",2022,", there was no significant difference in the scores of FMA-UE, MBI, MAS, and motor nerve electrophysiological indexes among the four groups, with comparability.","['240 stroke patients with hemiplegia who met the inclusion criteria', 'Stroke Patients with Hemiplegia', 'stroke patients with hemiplegia']","['Neuromuscular Electrical Stimulation Combined with Repetitive Transcranial Magnetic Stimulation', 'neuromuscular electrical stimulation (NMES) combined with repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'control group, NMES group, rTMS group, and NMES + rTMS', 'NMES + rTMS']","['upper extremity motor function and activities of daily life', 'Upper Limb Motor Function Rehabilitation', 'Fugl-Meyer assessment of upper extremity (FMA-UE) motor function, modified Barthel index (MBI), modified Ashworth scale (MAS), and motor nerve electrophysiological results', 'scores of FMA-UE, MBI, MAS, and motor nerve electrophysiological indexes']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",240.0,0.00860687,", there was no significant difference in the scores of FMA-UE, MBI, MAS, and motor nerve electrophysiological indexes among the four groups, with comparability.","[{'ForeName': 'Junqiu', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': ""Department of Rehabilitation Medicine, Huai'an Second People's Hospital (The Affiliated Huai'an Hospital of Xuzhou Medical University), Huai'an, Jiangsu 223002, China.""}, {'ForeName': 'Shouyong', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Huai'an NO.3 People's Hospital, Huai'an, Jiangsu 223002, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Department of Rehabilitation Medicine, Huai'an NO.3 People's Hospital, Huai'an, Jiangsu 223002, China.""}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Rehabilitation Medicine, Huai'an Second People's Hospital (The Affiliated Huai'an Hospital of Xuzhou Medical University), Huai'an, Jiangsu 223002, China.""}, {'ForeName': 'Xuejing', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Rehabilitation Medicine, Huai'an Second People's Hospital (The Affiliated Huai'an Hospital of Xuzhou Medical University), Huai'an, Jiangsu 223002, China.""}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Gan', 'Affiliation': ""Department of Rehabilitation Medicine, Huai'an Second People's Hospital (The Affiliated Huai'an Hospital of Xuzhou Medical University), Huai'an, Jiangsu 223002, China.""}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Rehabilitation Medicine, Lianshui County People's Hospital (Affiliated Hospital of Kangda College, Nanjing Medical University), Huai'an, Jiangsu 223400, China.""}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Rehabilitation Medicine, Lianshui County People's Hospital (Affiliated Hospital of Kangda College, Nanjing Medical University), Huai'an, Jiangsu 223400, China.""}, {'ForeName': 'Xiaorui', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': ""Department of Rehabilitation Medicine, Lianshui County People's Hospital (Affiliated Hospital of Kangda College, Nanjing Medical University), Huai'an, Jiangsu 223400, China.""}]",Computational and mathematical methods in medicine,['10.1155/2022/9455428']
3485,35013896,One Anastomosis Gastric Bypass Versus Long Biliopancreatic Limb Roux-en-Y Gastric Bypass.,"BACKGROUND


Roux-en-Y gastric bypass (RYGB) is one of the most effective bariatric procedures. The study aimed to explore the value of lengthening the biliopancreatic limb (BPL) in RYGB compared to the outcome of one-anastomosis gastric bypass (OAGB).
METHODS


This prospective study included morbidly obese patients divided into two groups. The RYGB group (n = 36) was subjected to long biliary limb Roux-en-Y gastric bypass (LPRYGB), and the OAGB Group (n = 36) had one anastomosis gastric bypass. During follow-up, weight, BMI, percentage of excess body weight loss (%EBWL), resolution of obesity-related comorbidities, and quality of life (QoL) were evaluated.
RESULTS


There was no significant difference in weight and BMI after 3 and 6 months. At 12-month follow-up, weight loss was significantly higher in the OAGB group. After 12 months, the two groups showed significant improvement of comorbid conditions without significant difference between the two groups. The Qol was significantly higher in the LPRYGB group 3, 6, and 12 months after surgery compared to the OAGB group.
CONCLUSIONS


Extending the BPL length in RYGB to 150 cm is as effective as OAGB in remission of comorbidities, including diabetes. It was also equally effective in weight reduction in the short term. OAGB was more efficient in weight reduction and a significantly faster operation. LPRYGB showed a better QoL of life 1 year after surgery.",2022,"After 12 months, the two groups showed significant improvement of comorbid conditions without significant difference between the two groups.",['morbidly obese patients divided into two groups'],"['anastomosis gastric bypass (OAGB', 'Roux-en-Y gastric bypass (RYGB', 'biliary limb Roux-en-Y gastric bypass (LPRYGB), and the OAGB Group (n\u2009=\u200936) had one anastomosis gastric bypass', 'Anastomosis Gastric Bypass Versus Long Biliopancreatic Limb Roux-en-Y Gastric Bypass', 'OAGB']","['comorbid conditions', 'weight, BMI, percentage of excess body weight loss (%EBWL), resolution of obesity-related comorbidities, and quality of life (QoL', 'weight loss', 'Qol', 'weight reduction', 'weight and BMI']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.00714301,"After 12 months, the two groups showed significant improvement of comorbid conditions without significant difference between the two groups.","[{'ForeName': 'Mohamed Y', 'Initials': 'MY', 'LastName': 'Ibrahim', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Cairo University Hospitals Manial, Cairo, 11555, Egypt.'}, {'ForeName': 'Abdelmoneim S', 'Initials': 'AS', 'LastName': 'Elshennawy', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Cairo University Hospitals Manial, Cairo, 11555, Egypt.'}, {'ForeName': 'Arsany Talaat Saber', 'Initials': 'ATS', 'LastName': 'Wassef', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Cairo University Hospitals Manial, Cairo, 11555, Egypt.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Salah', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Cairo University Hospitals Manial, Cairo, 11555, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Hassan', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Cairo University Hospitals Manial, Cairo, 11555, Egypt.'}, {'ForeName': 'Sameh', 'Initials': 'S', 'LastName': 'Mikhail', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Cairo University Hospitals Manial, Cairo, 11555, Egypt. samehmikhail@kasralainy.edu.eg.'}]",Obesity surgery,['10.1007/s11695-021-05874-0']
3486,35016914,"Escitalopram administration, relearning, and neuroplastic effects: A diffusion tensor imaging study in healthy individuals.","BACKGROUND


Neuroplastic processes are influenced by serotonergic agents, which reportedly alter white matter microstructure in humans in conjunction with learning. The goal of this double-blind, placebo-controlled imaging study was to investigate the neuroplastic properties of escitalopram and cognitive training on white matter plasticity during (re)learning as a model for antidepressant treatment and environmental factors.
METHODS


Seventy-one healthy individuals (age=25.6 ± 5.0, 43 females) underwent three diffusion magnetic resonance imaging scans: at baseline, after 3 weeks of associative learning (emotional/non-emotional content), and after relearning shuffled associations for an additional 3 weeks. During the relearning phase, participants received a daily dose of 10 mg escitalopram or placebo orally. Fractional anisotropy (FA), and mean (MD), axial (AD), and radial diffusivity (RD) were calculated within the FMRIB software library and analyzed using tract-based spatial statistics.
RESULTS


In a three-way repeated-measures marginal model with sandwich estimator standard errors, we found no significant effects of escitalopram and content on AD, FA, MD, and RD during both learning and relearning periods (p FDR >0.05). When testing for escitalopram or content effects separately, we also demonstrated no significant findings (p FDR >0.05) for any of the diffusion tensor imaging metrics.
LIMITATIONS


The intensity of the study interventions might have been too brief to induce detectable white matter changes.
DISCUSSION


Previous studies examining the effects of SSRIs on white matter tracts in humans have yielded inconclusive outcomes. Our results indicate that relearning under escitalopram does not affect the white matter microstructures in healthy individuals when administered for 3 weeks.",2022,Our results indicate that relearning under escitalopram does not affect the white matter microstructures in healthy individuals when administered for 3 weeks.,"['Seventy-one healthy individuals (age=25.6\xa0±\xa05.0, 43 females) underwent', 'healthy individuals']","['placebo', 'associative learning (emotional/non-emotional content', 'escitalopram or placebo', 'escitalopram and cognitive training', 'three diffusion magnetic resonance imaging scans', 'SSRIs']","['white matter microstructures', 'escitalopram and content on AD, FA, MD, and RD during both learning and relearning periods', 'Fractional anisotropy (FA), and mean (MD), axial (AD), and radial diffusivity (RD']","[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009649', 'cui_str': 'Conditioning, Classical'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1136216', 'cui_str': 'Magnetic Resonance Imaging, Diffusion'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205131', 'cui_str': 'Axial'}]",71.0,0.174449,Our results indicate that relearning under escitalopram does not affect the white matter microstructures in healthy individuals when administered for 3 weeks.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vanicek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Reed', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Unterholzner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Klöbl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Godbersen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Handschuh', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Spurny-Dworak', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ritter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gryglewski', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Winkler', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lanzenberger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria. Electronic address: rupert.lanzenberger@meduniwien.ac.at.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Seiger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.'}]",Journal of affective disorders,['10.1016/j.jad.2021.12.135']
3487,35020797,Antibiotic prophylaxis for acute cholecystectomy: PEANUTS II multicentre randomized non-inferiority clinical trial.,"BACKGROUND


Guidelines recommending antibiotic prophylaxis at emergency cholecystectomy for cholecystitis were based on low-quality evidence. The aim of this trial was to demonstrate that omitting antibiotics is not inferior to their prophylactic use.
METHODS


This multicentre, randomized, open-label, non-inferiority clinical trial randomly assigned adults with mild-to-moderate acute calculous cholecystitis (immediate cholecystectomy indicated) to 2 g cefazolin administered before incision or no antibiotic prophylaxis. The primary endpoint was a composite of all postoperative infectious complications in the first 30 days after surgery. Secondary endpoints included all individual components of the primary endpoint, other morbidity, and duration of hospital stay.
RESULTS


Sixteen of 226 patients (7.1 per cent) in the single-dose prophylaxis group and 29 of 231 (12.6 per cent) in the no-prophylaxis group developed postoperative infectious complications (absolute difference 5.5 (95 per cent c.i. -0.4 to 11.3) per cent). With a non-inferiority margin of 10 per cent, non-inferiority of no prophylaxis was not proven. The number of surgical-site infections was significantly higher in the no-prophylaxis group (5.3 versus 12.1 per cent; P = 0.010). No differences were observed in the number of other complications, or duration of hospital stay.
CONCLUSION


Omitting antibiotic prophylaxis is not recommended.",2022,"No differences were observed in the number of other complications, or duration of hospital stay.
","['adults with mild-to-moderate acute calculous cholecystitis (immediate cholecystectomy indicated) to 2 g', 'acute cholecystectomy']","['cefazolin administered before incision or no antibiotic prophylaxis', 'Antibiotic prophylaxis']","['individual components of the primary endpoint, other morbidity, and duration of hospital stay', 'composite of all postoperative infectious complications', 'number of other complications, or duration of hospital stay', 'postoperative infectious complications', 'number of surgical-site infections']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0149520', 'cui_str': 'Acute cholecystitis'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}]",,0.331186,"No differences were observed in the number of other complications, or duration of hospital stay.
","[{'ForeName': 'Willemieke G', 'Initials': 'WG', 'LastName': 'van Braak', 'Affiliation': 'Department of Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Jeroen E H', 'Initials': 'JEH', 'LastName': 'Ponten', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Loozen', 'Affiliation': 'Department of Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Judith P M', 'Initials': 'JPM', 'LastName': 'Schots', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Anna A W', 'Initials': 'AAW', 'LastName': 'van Geloven', 'Affiliation': 'Department of Surgery, Tergooi Hospital, Hilversum, the Netherlands.'}, {'ForeName': 'Sandra C', 'Initials': 'SC', 'LastName': 'Donkervoort', 'Affiliation': 'Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Grard A P', 'Initials': 'GAP', 'LastName': 'Nieuwenhuijzen', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Amsterdam Gastroenterology Endocrinology Metabolism, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Tjarda N T', 'Initials': 'TNT', 'LastName': 'van Heek', 'Affiliation': 'Department of Surgery, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'de Reuver', 'Affiliation': 'Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Vlaminckx', 'Affiliation': 'Department of Medical Microbiology and Immunology, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Kelder', 'Affiliation': 'Department of Clinical Epidemiology, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Catherijne A J', 'Initials': 'CAJ', 'LastName': 'Knibbe', 'Affiliation': 'Department of Clinical Pharmacy, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Hjalmar C', 'Initials': 'HC', 'LastName': 'van Santvoort', 'Affiliation': 'Department of Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Djamila', 'Initials': 'D', 'LastName': 'Boerma', 'Affiliation': 'Department of Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.'}]",The British journal of surgery,['10.1093/bjs/znab441']
3488,35020796,"Effect of a single high dose of vitamin D3 on cytokines, chemokines, and growth factor in patients with moderate to severe COVID-19.","BACKGROUND


The modulating effect of vitamin D on cytokine concentrations in severe coronavirus disease 2019 (COVID-19) remains unknown.
OBJECTIVES


We aimed to investigate the effect of a single high dose of vitamin D3 on cytokines, chemokines, and growth factor in hospitalized patients with moderate to severe COVID-19.
METHODS


This is a post hoc, ancillary, and exploratory analysis from a multicenter, double-blind, placebo-controlled, randomized clinical trial. Patients with moderate to severe COVID-19 were recruited from 2 hospitals in São Paulo, Brazil. Of 240 randomly assigned patients, 200 were assessed in this study and randomly assigned to receive a single oral dose of 200,000 IU vitamin D3 (n = 101) or placebo (n = 99). The primary outcome was hospital length of stay, which has been published in our previous study. The prespecified secondary outcomes were serum concentrations of IL-1β, IL-6, IL-10, TNF-α, and 25-hydroxyvitamin D. The post hoc exploratory secondary outcomes were IL-4, IL-12p70, IL-17A, IFN-γ, granulocyte-macrophage colony-stimulating factor (GM-CSF), IL-8, IFN-inducible protein-10 (IP-10), macrophage inflammatory protein-1β (MIP-1β), monocyte chemoattractant protein-1 (MCP-1), vascular endothelial growth factor (VEGF), and leukocyte count. Generalized estimating equations for repeated measures, with Bonferroni's adjustment, were used for testing all outcomes.
RESULTS


The study included 200 patients with a mean ± SD age of 55.5 ± 14.3 y and BMI of 32.2 ± 7.1 kg/m2, of which 109 (54.5%) were male. GM-CSF concentrations showed a significant group-by-time interaction effect (P = 0.04), although the between-group difference at postintervention after Bonferroni's adjustment was not significant. No significant effects were observed for the other outcomes.
CONCLUSIONS


The findings do not support the use of a single dose of 200,000 IU vitamin D3, compared with placebo, for the improvement of cytokines, chemokines, and growth factor in hospitalized patients with moderate to severe COVID-19.This trial was registered at clinicaltrials.gov as NCT04449718.",2022,"The post-hoc exploratory secondary outcomes were interleukin-4, interleukin-12p70, interleukin-17A, interferon gamma (IFN-γ), granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-8, interferon-inducible protein-10 (IP-10), macrophage inflammatory protein-1 beta (MIP-1β), monocyte chemoattractant protein-1 (MCP-1), growth factor vascular endothelial (VEGF), and leukocytes count.","['patients with moderate to severe COVID-19', 'severe coronavirus disease 2019 (COVID-19', 'Patients with moderate to severe COVID-19 were recruited from two hospitals in Sao Paulo, Brazil', '200 patients with a mean (SD) age 55.5 (14.3) years and body mass index (BMI) 32.2 (7.1) kg/m2, of which 109 (54.5%) were male', 'hospitalized patients with moderate to severe COVID-19']","['vitamin D', 'placebo', 'vitamin D3', 'Vitamin D3', 'vitamin D3 ']","['hospital length of stay', 'cytokines, chemokines, and growth factor', 'serum levels of interleukin-1β, interleukin-6, interleukin-10, tumor necrosis factor alpha (TNF-α) and 25-hydroxyvitamin D', 'cytokines, chemokines and growth factor', 'time interaction effect', 'interleukin-4, interleukin-12p70, interleukin-17A, interferon gamma (IFN-γ), granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-8, interferon-inducible protein-10 (IP-10), macrophage inflammatory protein-1 beta (MIP-1β), monocyte chemoattractant protein-1 (MCP-1), growth factor vascular endothelial (VEGF), and leukocytes count', 'GM-CSF levels', 'cytokine levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0056978', 'cui_str': 'CXCL10 Chemokine'}, {'cui': 'C1533698', 'cui_str': 'Nitric Oxide Synthase, Type II'}, {'cui': 'C0209338', 'cui_str': 'MIP-1beta'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]",200.0,0.57442,"The post-hoc exploratory secondary outcomes were interleukin-4, interleukin-12p70, interleukin-17A, interferon gamma (IFN-γ), granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-8, interferon-inducible protein-10 (IP-10), macrophage inflammatory protein-1 beta (MIP-1β), monocyte chemoattractant protein-1 (MCP-1), growth factor vascular endothelial (VEGF), and leukocytes count.","[{'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Fernandes', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Igor H', 'Initials': 'IH', 'LastName': 'Murai', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Bruna Z', 'Initials': 'BZ', 'LastName': 'Reis', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Sales', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mayara D', 'Initials': 'MD', 'LastName': 'Santos', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ana J', 'Initials': 'AJ', 'LastName': 'Pinto', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Karla F', 'Initials': 'KF', 'LastName': 'Goessler', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Camila S C', 'Initials': 'CSC', 'LastName': 'Duran', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Carla B R', 'Initials': 'CBR', 'LastName': 'Silva', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'André S', 'Initials': 'AS', 'LastName': 'Franco', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Marina B', 'Initials': 'MB', 'LastName': 'Macedo', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Henrique H H', 'Initials': 'HHH', 'LastName': 'Dalmolin', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Janaina', 'Initials': 'J', 'LastName': 'Baggio', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Guilherme G M', 'Initials': 'GGM', 'LastName': 'Balbi', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Antonangelo', 'Affiliation': 'Clinical Pathology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina da Universidade de Sao Paulo,, Sao Paulo, Brazil.'}, {'ForeName': 'Valeria F', 'Initials': 'VF', 'LastName': 'Caparbo', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Rosa M R', 'Initials': 'RMR', 'LastName': 'Pereira', 'Affiliation': 'Rheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab426']
3489,35020795,Effect of fat-reformulated dairy food consumption on postprandial flow-mediated dilatation and cardiometabolic risk biomarkers compared with conventional dairy: a randomized controlled trial.,"BACKGROUND


Longer-term consumption of SFA-reduced, MUFA-enriched dairy products has been reported to improve fasting flow-mediated dilatation (FMD). Yet, their impact on endothelial function in the postprandial state warrants investigation.
OBJECTIVES


The aim was to compare the impact of a fatty acid (FA) modified with a conventional (control) dairy diet on the postprandial %FMD (primary outcome) and systemic cardiometabolic responses to representative meals, and retrospectively explore whether treatment effects differ by apolipoprotein E (APOE) or endothelial NO synthase (eNOS) Glu298Asp gene polymorphisms.
METHODS


In a crossover-design randomized controlled study, 52 adults with moderate cardiovascular disease risk consumed dairy products [38% of total energy intake (%TE) from fat: FA-modified (target: 16%TE SFAs; 14%TE MUFAs) or control (19%TE SFAs; 11%TE MUFAs)] for 12 wk, separated by an 8-wk washout. Blood sampling and FMD measurements (0-480 min) were performed pre- and postintervention after sequential mixed meals that were representative of the assigned dairy diets (0 min, ∼50 g fat; 330 min, ∼30 g fat).
RESULTS


Relative to preintervention (∆), the FA-modified dairy diet and meals (treatment) attenuated the increase in the incremental AUC (iAUC), but not AUC, for the %FMD response observed with the conventional treatment (-135 ± 69% vs. +199 ± 82% × min; P = 0.005). The ∆ iAUC, but not AUC, for the apoB response decreased after the FA-modified treatment yet increased after the conventional treatment (-4 ± 3 vs. +3 ± 3 mg/mL × min; P = 0.004). The ∆ iAUC decreased for plasma total SFAs (P = 0.003) and trans 18:1 (P < 0.0001) and increased for cis-MUFAs (P < 0.0001) following the conventional relative to the FA-modified treatment. No treatment × APOE or eNOS genotype interactions were evident for any outcome.
CONCLUSIONS


This study provides novel insights into the longer-term effects of FA-modified dairy food consumption on postprandial cardiometabolic responses.",2022,"The ∆ iAUC decreased for total plasma SFAs (P = 0.003) and trans 18:1 (P < 0.0001) and increased for cis-MUFAs (P < 0.0001) following conventional, relative to the FA-modified treatment.",['52 adults with moderate cardiovascular disease risk consumed dairy products [38% total energy intake (%TE) from fat'],"['URL', 'saturated fatty acid (SFA)-reduced, monounsaturated fatty acid (MUFA)-enriched dairy products', 'apolipoprotein (APO)E or endothelial nitric oxide synthase', 'FA-modified (target: 16%TE SFAs; 14%TE MUFAs) or control (19%TE SFAs; 11%TE MUFAs', 'fatty acid (FA)-modified with a conventional (control) dairy diet', 'conventional dairy', 'fat reformulated dairy food consumption', 'FA-modified dairy food consumption']","['postprandial flow-mediated dilatation and cardiometabolic risk biomarkers', 'postprandial cardiometabolic responses', 'apoB response', 'total plasma SFAs', 'fasting flow-mediated vasodilation (FMD', 'endothelial function', 'incremental AUC (iAUC', 'FMD response', 'Blood sampling and FMD measurements', 'cis-MUFAs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0010947', 'cui_str': 'Dairy foods'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0010947', 'cui_str': 'Dairy foods'}, {'cui': 'C0003595', 'cui_str': 'Apolipoprotein E'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0007099', 'cui_str': 'Carcinoma in situ'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}]",52.0,0.155445,"The ∆ iAUC decreased for total plasma SFAs (P = 0.003) and trans 18:1 (P < 0.0001) and increased for cis-MUFAs (P < 0.0001) following conventional, relative to the FA-modified treatment.","[{'ForeName': 'Oonagh', 'Initials': 'O', 'LastName': 'Markey', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Dafni', 'Initials': 'D', 'LastName': 'Vasilopoulou', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Kirsty E', 'Initials': 'KE', 'LastName': 'Kliem', 'Affiliation': 'Animal, Dairy, and Food Chain Sciences, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Colette C', 'Initials': 'CC', 'LastName': 'Fagan', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Alistair S', 'Initials': 'AS', 'LastName': 'Grandison', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sutton', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Humphries', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Todd', 'Affiliation': 'Department of Mathematics and Statistics, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Kim G', 'Initials': 'KG', 'LastName': 'Jackson', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Givens', 'Affiliation': 'Institute for Food, Nutrition, and Health, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Lovegrove', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqab428']
3490,34887568,Exploratory results from the CheckMate 214 trial.,,2022,,[],[],[],[],[],[],,0.1069,,"[{'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Masone', 'Affiliation': 'Nature Reviews Urology, . mariachiara.masone@nature.com.'}]",Nature reviews. Urology,['10.1038/s41585-021-00553-2']
3491,34920097,A phase II randomized trial to evaluate the long-term (12-week) efficacy and safety of OC-01 (varenicline solution) nasal spray for dry eye disease: The MYSTIC study.,"PURPOSE


Dry eye disease is characterized by loss of tear film stability. OC-01 (varenicline solution) is a small-molecule nicotinic acetylcholine receptor agonist administered as a nasal spray that stimulates tear production.
METHODS


In MYSTIC (NCT03873246) patients aged ≥22 years with dry eye disease were randomized 1:1:1 to OC-01 0.03 mg, OC-01 0.06 mg, or vehicle (n = 41 per group), administered twice daily via intranasal spray, for 12 weeks (84 days). Primary efficacy endpoint was mean change from baseline in anesthetized Schirmer's test score (STS) in study eye at day (D) 84.
RESULTS


Patients receiving OC-01 0.03 and 0.06 mg had statistically significantly increased tear production at D84 versus vehicle; least squares mean changes from baseline in STS were 10.8 mm and 11.0 mm for OC-01 0.03 and 0.06 mg, respectively. A trend toward a higher proportion of patients experiencing ≥10-mm improvement in STS from baseline was observed with OC-01 0.03 mg (36.6%; p > 0.05), and was significant for OC-01 0.06 mg (48.8%; p = 0.024), versus vehicle (24.4%). Non-ocular treatment-emergent adverse events (TEAEs) were reported by 21 patients; the most common was sneezing (OC-01 0.03 mg, 2 [4.9%]; OC-01 0.06 mg, 3 [7.3%]), with similar frequencies between treatment groups. No severe or serious TEAEs were reported.
CONCLUSIONS


OC-01 (varenicline solution) nasal spray improved tear production in patients with dry eye disease over a long-term (12-week) period, and represents a receptor neuro-activator with a nasal route of administration that spares the ocular surface to stimulate tear production.",2021,"RESULTS


Patients receiving OC-01 0.03 and 0.06 mg had statistically significantly increased tear production at D84 versus vehicle; least squares mean changes from baseline in STS were 10.8 mm and 11.0 mm for OC-01 0.03 and 0.06 mg, respectively.","['patients aged ≥22 years with dry eye disease', 'dry eye disease', 'patients with dry eye disease']","['OC-01 (varenicline solution', 'OC-01 (varenicline solution) nasal spray', 'OC-01 0.03\xa0mg, OC-01 0.06\xa0mg, or vehicle']","['severe or serious TEAEs', 'tear production', ""anesthetized Schirmer's test score (STS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0423153', 'cui_str': 'Lacrimation'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0551605,"RESULTS


Patients receiving OC-01 0.03 and 0.06 mg had statistically significantly increased tear production at D84 versus vehicle; least squares mean changes from baseline in STS were 10.8 mm and 11.0 mm for OC-01 0.03 and 0.06 mg, respectively.","[{'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Quiroz-Mercado', 'Affiliation': 'Asociación Para Evitar la Ceguera en Mexico, Retina Service, Vicente Garcia Torres # 46, Coyoacan, 04330, Mexico City, Mexico.'}, {'ForeName': 'Everardo', 'Initials': 'E', 'LastName': 'Hernandez-Quintela', 'Affiliation': 'Asociación Para Evitar la Ceguera en Mexico, Retina Service, Vicente Garcia Torres # 46, Coyoacan, 04330, Mexico City, Mexico; Asociación para Evitar la Ceguera en México (APEC), Cornea and Refractive Surgery Service, Mexico City, Mexico.'}, {'ForeName': 'Kuei Hsun', 'Initials': 'KH', 'LastName': 'Chiu', 'Affiliation': 'Firma Clinical Research, Hunt Valley, MD, USA.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Henry', 'Affiliation': 'Firma Clinical Research, Hunt Valley, MD, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Nau', 'Affiliation': 'Oyster Point Pharma, Inc., Princeton, NJ, USA. Electronic address: jnau@oysterpointrx.com.'}]",The ocular surface,['10.1016/j.jtos.2021.12.007']
3492,35027167,A randomised trial of adaptive support ventilation in patients with neuroparalytic snake envenomation.,,2022,,['patients with neuroparalytic snake envenomation'],['adaptive support ventilation'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037379', 'cui_str': 'Poisoning by venomous snake'}]","[{'cui': 'C4285752', 'cui_str': 'Adaptive servo-ventilation'}]",[],,0.0742064,,"[{'ForeName': 'Inderpaul S', 'Initials': 'IS', 'LastName': 'Sehgal', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. Electronic address: inderpgi@outlook.com.'}, {'ForeName': 'Raghava R', 'Initials': 'RR', 'LastName': 'Gandra', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Sahajal', 'Initials': 'S', 'LastName': 'Dhooria', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Ashutosh N', 'Initials': 'AN', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Kuruswamy T', 'Initials': 'KT', 'LastName': 'Prasad', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Valliappan', 'Initials': 'V', 'LastName': 'Muthu', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Internal Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Ritesh', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}]",British journal of anaesthesia,['10.1016/j.bja.2021.12.015']
3493,35029720,Psychological intervention in women with Mayer-Rokitansky-Küster-Hauser syndrome after artificial vaginoplasty: a prospective study.,"INTRODUCTION AND HYPOTHESIS


The negative psychological impact on women with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome is long-lasting, resulting from not only the disease itself, but also the cumbersome and painful treatment process. However, little is known about the postoperative psychological status of these patients and related interventions to improve mental health. Here, in our study, we postulated that mental disorders exist in MRKH patients with a surgical neovagina and that psychological intervention will be helpful.
METHODS


Thirty MRKH women who had undergone vaginoplasty were enrolled. All patients had received psychological interventions since February 2020. Depression and anxiety questionnaires prior to and 2 weeks after the final intervention were recorded.
RESULTS


Before intervention, among 30 MRKH patients after artificial vaginoplasty, the median depression score was 6.00 (25th/75th percentile, 0.00/7.00), and the median anxiety score was 4.00 (25th/75th percentile, 1.00/7.00). After intervention, women's depression (p < 0.001) and anxiety (p < 0.001) scores significantly decreased. The median depression score was 0.00 (25th/75th percentile, 0.00/3.00), and the median anxiety score was 1.00 (25th/75th percentile, 0.00/3.25). Furthermore, stratified analysis found that the depression (p = 0.029) and anxiety (p = 0.019) scores both improved when intervention was performed within 12 months postoperatively.
CONCLUSIONS


MRKH patients are at a great risk of depression and anxiety problems after artificial vaginoplasty. Early psychological intervention can alleviate these symptoms. Ongoing psychological support was needed to eliminate emotional burden during MRKH treatment, and further study is sorely needed to identify its appropriate timing and method.",2022,"After intervention, women's depression (p < 0.001) and anxiety (p < 0.001) scores significantly decreased.","['Thirty MRKH women who had undergone vaginoplasty were enrolled', 'MRKH patients with a surgical neovagina and that psychological intervention', 'All patients had received psychological interventions since February 2020', 'women with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome', 'women with Mayer-Rokitansky-Küster-Hauser syndrome after artificial vaginoplasty']",['Psychological intervention'],"['Depression and anxiety questionnaires', 'median depression score', 'anxiety', 'median anxiety score']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1288276', 'cui_str': 'Vaginoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.027674,"After intervention, women's depression (p < 0.001) and anxiety (p < 0.001) scores significantly decreased.","[{'ForeName': 'Shuyi', 'Initials': 'S', 'LastName': 'Shao', 'Affiliation': 'Obstetrics and Gynecology Hospital, Fudan University, Huangpu District, Fangxie Road 419, Shanghai, 200011, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Obstetrics and Gynecology Hospital, Fudan University, Huangpu District, Fangxie Road 419, Shanghai, 200011, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'Obstetrics and Gynecology Hospital, Fudan University, Huangpu District, Fangxie Road 419, Shanghai, 200011, China.'}, {'ForeName': 'Keqin', 'Initials': 'K', 'LastName': 'Hua', 'Affiliation': 'Obstetrics and Gynecology Hospital, Fudan University, Huangpu District, Fangxie Road 419, Shanghai, 200011, China. huakeqinjiaoshou@163.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Obstetrics and Gynecology Hospital, Fudan University, Huangpu District, Fangxie Road 419, Shanghai, 200011, China. 13818218839@163.com.'}]",International urogynecology journal,['10.1007/s00192-022-05075-y']
3494,34953401,Preloading magnesium attenuates cisplatin-associated nephrotoxicity: pilot randomized controlled trial (PRAGMATIC study).,"BACKGROUND


Cisplatin is one of the most potent chemotherapeutic drugs used in head and neck cancer treatment; however, nephrotoxicity is the major side-effect limiting usage. Magnesium supplementation has been reported to reduce risk in non-controlled studies. We investigated whether preloading with magnesium prevents nephrotoxicity with a low-dose weekly cisplatin regimen.
METHODS


We carried out a prospective pilot, single-blinded, randomized controlled trial to compare cisplatin-associated acute kidney injury (cis-AKI) and acute kidney disease (cis-AKD) between two groups: intravenous 0.9% NaCl 500 ml + KCL 20 mEq over 4 h pre-cisplatin 40 mg/m 2  weekly for 7-8 weeks (control group) compared with additional 16 mEq magnesium added to the saline infusion (Mg group) in 30 head and neck cancer patients. Cis-AKI was defined as an increased serum creatinine (SCr) ≥ 0.3 mg/dl within 7 days and cis-AKD is an increased SCr ≥ 0.3 mg/dl between last SCr and baseline pre-chemotherapy SCr.
RESULTS


The overall cisplatin tumor response rate and survival were comparable between groups. The baseline characteristics were comparable between groups, although SCr was lower in the controls (0.70 ± 0.17 versus 0.87 ± 0.17 mg/dl, P = 0.01). The incidence of cis-AKI was similar (4.6% versus 1.3%); however, the incidence of cis-AKD was higher for the control group (46.7% versus 6.7%, hazard ratio = 0.082, 95% confidence interval 0.008-0.79, P = 0.03). The time to develop cis-AKD was significantly shorter in the control group (P = 0.007).
CONCLUSIONS


The magnesium-preloading regimen was safe and significantly showed a decreased incidence of cis-AKD. The encouraging results of our pilot study need to be confirmed in a large-scale randomized controlled trial.",2022,"The time to develop cis-AKD was significantly shorter in the control group (P = 0.007).
","['associated nephrotoxicity', '30 head and neck cancer patients']","['intravenous 0.9% NaCl 500 ml\xa0+ KCL 20 mEq over 4 h pre-cisplatin 40 mg/m 2  weekly for 7-8 weeks (control group) compared with additional 16 mEq magnesium added to the saline infusion', 'Preloading magnesium attenuates cisplatin', 'magnesium', 'Cisplatin', 'cisplatin', 'Magnesium supplementation']","['time to develop cis-AKD', 'SCr', 'overall cisplatin tumor response rate and survival', 'incidence of cis-AKI', 'incidence of cis-AKD']","[{'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0032825', 'cui_str': 'Potassium Chloride'}, {'cui': 'C0439152', 'cui_str': 'mEq'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007099', 'cui_str': 'Carcinoma in situ'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]",,0.222166,"The time to develop cis-AKD was significantly shorter in the control group (P = 0.007).
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Suppadungsuk', 'Affiliation': 'Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Samut Prakan, Thailand.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Phitakwatchara', 'Affiliation': 'The 50(th) Anniversary Mahavajiralongkorn Hospital, Ubon Ratchathani, Thailand.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Reungwetwattana', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pathumarak', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Phakdeekitcharoen', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kitiyakara', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Srisuwarn', 'Affiliation': 'Division of Internal Medicine, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Davenport', 'Affiliation': 'UCL Centre for Nephrology, Royal Free Hospital, University College London, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nongnuch', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. Electronic address: oatega@yahoo.com.'}]",ESMO open,['10.1016/j.esmoop.2021.100351']
3495,35028615,Pharmacodynamic effects of direct AMP kinase activation in humans with insulin resistance and non-alcoholic fatty liver disease: A phase 1b study.,"AMPK is an energy sensor modulating metabolism, inflammation, and a target for metabolic disorders. Metabolic dysfunction results in lower AMPK activity. PXL770 is a direct AMPK activator, inhibiting  de novo  lipogenesis (DNL) and producing efficacy in preclinical models. We aimed to assess pharmacokinetics, safety, and pharmacodynamics of PXL770 in humans with metabolic syndrome-associated fatty liver disease. In a randomized, double-blind four-week trial, 12 overweight/obese patients with non-alcoholic fatty liver disease (NAFLD) and insulin resistance received PXL770 500 mg QD; 4 subjects received matching placebo. Endpoints included pharmacokinetics, hepatic fractional DNL, oral glucose tolerance testing, additional pharmacodynamic parameters, and safety. PK parameters show adequate plasma exposure in NAFLD patients for daily oral dosing. PXL770 decreases DNL-both peak and AUC are reduced versus baseline-and improves glycemic parameters and indices of insulin sensitivity versus baseline. Assessment of specific lipids reveals decrease in diacyglycerols/triacylglycerols. Safety/tolerability are similar to placebo. These results unveil initial human translation of AMPK activation and support this therapeutic strategy for metabolic disorders.",2021,PXL770 decreases DNL-both peak and AUC are reduced versus baseline-and improves glycemic parameters and indices of insulin sensitivity versus baseline.,"['humans with insulin resistance and non-alcoholic fatty liver disease', '12 overweight/obese patients with non-alcoholic fatty liver disease (NAFLD) and insulin resistance received', 'humans with metabolic syndrome-associated fatty liver disease']","['placebo', 'direct AMP kinase activation', 'matching placebo', 'PXL770 500\xa0mg QD', 'PXL770']","['Safety/tolerability', 'PXL770 decreases DNL-both peak and AUC', 'pharmacokinetics, hepatic fractional DNL, oral glucose tolerance testing, additional pharmacodynamic parameters, and safety', 'glycemic parameters and indices of insulin sensitivity', 'diacyglycerols/triacylglycerols']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0001497', 'cui_str': 'Adenylate kinase'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",12.0,0.203917,PXL770 decreases DNL-both peak and AUC are reduced versus baseline-and improves glycemic parameters and indices of insulin sensitivity versus baseline.,"[{'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Fouqueray', 'Affiliation': 'Poxel SA, Lyon, Auvergne-Rhône-Alpes, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Bolze', 'Affiliation': 'Poxel SA, Lyon, Auvergne-Rhône-Alpes, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dubourg', 'Affiliation': 'Poxel SA, Lyon, Auvergne-Rhône-Alpes, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hallakou-Bozec', 'Affiliation': 'Poxel SA, Lyon, Auvergne-Rhône-Alpes, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Theurey', 'Affiliation': 'Poxel SA, Lyon, Auvergne-Rhône-Alpes, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Grouin', 'Affiliation': 'University of Rouen, Rouen, Normandie, France.'}, {'ForeName': 'Clémence', 'Initials': 'C', 'LastName': 'Chevalier', 'Affiliation': 'Poxel SA, Lyon, Auvergne-Rhône-Alpes, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Gluais-Dagorn', 'Affiliation': 'Poxel SA, Lyon, Auvergne-Rhône-Alpes, France.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Moller', 'Affiliation': 'Poxel SA, Lyon, Auvergne-Rhône-Alpes, France.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Cusi', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, FL, USA.'}]",Cell reports. Medicine,['10.1016/j.xcrm.2021.100474']
3496,34898444,Examining the Impact of Question Construction on Reporting of Sexual Identity: Survey Experiment Among Young Adults.,"BACKGROUND


Compared with heterosexuals, sexual minorities in the United States experience a higher incidence of negative physical and mental health outcomes. However, a variety of measurement challenges limit researchers' ability to conduct meaningful survey research to understand these disparities. Despite the prevalence of additional identities, many national health surveys only offer respondents 3 substantive options for reporting their sexual identities (straight/heterosexual, gay or lesbian, and bisexual), which could lead to measurement error via misreporting and item nonresponse.
OBJECTIVE


This study compared the traditional 3-option approach to measuring sexual identity with an expanded approach that offered respondents 5 additional options.
METHODS


An online survey experiment conducted among New Jersey residents between March and June 2021 randomly assigned 1254 young adults (ages 18-21) to answer either the 3-response measure of sexual identity or the expanded item. Response distributions for each measure were compared as were the odds of item nonresponse.
RESULTS


The expanded version of the question appeared to result in more accurate reporting among some subgroups and induced less item nonresponse; 12% (77/642) of respondents in the expanded version selected a response that was not available in the shorter version. Females answering the expanded item were less likely to identify as gay or lesbian (2.1% [10/467] vs. 6.6% [30/457]). Females and Non-Hispanic Whites were slightly more likely to skip the shorter version than the longer version (1.1% [5/457 for females and 3/264 for Non-Hispanic Whites] vs. 0% [0/467 for females and 0/277 for Non-Hispanic Whites]). About 5% (32/642) of respondents answering the longer item were unsure of their sexual identity (a similar option was not available in the shorter version). Compared with respondents answering the longer version of the question, those answering the shorter version had substantially greater odds of skipping the question altogether (odds ratio 9.57, 95% CI 1.21-75.74; P=.03).
CONCLUSIONS


Results favor the use of a longer, more detailed approach to measuring sexual identity in epidemiological research. Such a measure will likely allow researchers to produce more accurate estimates of health behaviors and outcomes among sexual minorities.",2021,"Compared with respondents answering the longer version of the question, those answering the shorter version had substantially greater odds of skipping the question altogether (odds ratio 9.57, 95% CI 1.21-75.74; P=.03).
","['Young Adults', 'Females and Non', 'New Jersey residents between March and June 2021 randomly assigned 1254 young adults (ages 18-21', 'Hispanic Whites']",[],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027971', 'cui_str': 'New Jersey'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",[],[],1254.0,0.0369008,"Compared with respondents answering the longer version of the question, those answering the shorter version had substantially greater odds of skipping the question altogether (odds ratio 9.57, 95% CI 1.21-75.74; P=.03).
","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Young', 'Affiliation': 'Center for Tobacco Studies, Rutgers Biomedical and Health Sciences, Rutgers University, New Brunswick, NJ, United States.'}, {'ForeName': 'Michelle T', 'Initials': 'MT', 'LastName': 'Bover Manderski', 'Affiliation': 'Center for Tobacco Studies, Rutgers Biomedical and Health Sciences, Rutgers University, New Brunswick, NJ, United States.'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Ganz', 'Affiliation': 'Center for Tobacco Studies, Rutgers Biomedical and Health Sciences, Rutgers University, New Brunswick, NJ, United States.'}, {'ForeName': 'Cristine D', 'Initials': 'CD', 'LastName': 'Delnevo', 'Affiliation': 'Center for Tobacco Studies, Rutgers Biomedical and Health Sciences, Rutgers University, New Brunswick, NJ, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hrywna', 'Affiliation': 'Center for Tobacco Studies, Rutgers Biomedical and Health Sciences, Rutgers University, New Brunswick, NJ, United States.'}]",JMIR public health and surveillance,['10.2196/32294']
3497,34895717,The effect of transnasal humidified rapid-insufflation ventilator exchange (THRIVE) versus nasal prongs on safe apnoea time in paralysed obese patients: a randomised controlled trial.,"BACKGROUND


Evidence is lacking regarding the efficacy of Optiflow transnasal humidified rapid-insufflation ventilator exchange (THRIVE™) in obese patients. We compared the impact of this technique at 70 L min -1  with 4 L min -1  oxygen via nasal prongs on safe apnoea times of paralysed obese patients.
METHODS


We randomised adults with a BMI >35 kg m -2  undergoing elective bariatric surgery. While apnoeic and paralysed, Group T received 70 L min -1  oxygen via Optiflow THRIVE™. Group N received nasal prong oxygen at 4 L min -1 . The primary outcome was time to SpO 2  ≤95% while apnoeic, with a 360 s cut-off. This was analysed by applying a time-to-event analysis.
RESULTS


Forty-two patients were included. The median (inter-quartile range) BMI was 44.8 kg m -2  (40.0-50.0) in Group T and 42.0 kg m -2  (39.3-45.1) in Group N. Median (inter-quartile range) time to SpO 2  ≤95% in Group T was 356 (165 to ≥360) s and in Group N, 210 (160-270) s. Using a survival analysis framework, median time-to-event in Group T was 356 s (95% confidence interval 165 s-upper limit not defined) and 210 s (95% confidence interval 160-242 s) (P=0.049) in Group N.
CONCLUSIONS


Compared with oxygen delivered via nasal prongs at 4 L min -1 , oxygen delivery via Optiflow THRIVE™ at a flow rate of 70 L min -1  can prolong safe apnoea time, however, the results are statistically inconclusive. Optiflow THRIVE™ did decrease the rate of reduction in Pa o2  during apnoea.
CLINICAL TRIAL REGISTRATION


ANZCTR 12618000445279.",2022,"Optiflow THRIVE™ did decrease the rate of reduction in Pa o2  during apnoea.
","['paralysed obese patients', 'Forty-two patients were included', 'obese patients', 'adults with a BMI >35 kg m -2  undergoing elective bariatric surgery']","['technique at 70 L min -1  with 4 L min -1  oxygen via nasal prongs', 'nasal prong oxygen', 'transnasal humidified rapid-insufflation ventilator exchange (THRIVE) versus nasal prongs', 'Optiflow transnasal humidified rapid-insufflation ventilator exchange (THRIVE™']","['safe apnoea time', 'time to SpO', 'survival analysis framework, median time-to-event', 'rate of reduction in Pa o2  during apnoea']","[{'cui': 'C0522224', 'cui_str': 'Paralysis'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0445087', 'cui_str': 'Nasal prongs'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C2938208', 'cui_str': 'Thrive'}]","[{'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",42.0,0.247423,"Optiflow THRIVE™ did decrease the rate of reduction in Pa o2  during apnoea.
","[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Guy', 'Affiliation': ""Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia; Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia. Electronic address: louisfguy@gmail.com.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': ""Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia; Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia.""}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Dodd', 'Affiliation': ""Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia; Division of Surgery, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Pelecanos', 'Affiliation': 'Statistics Unit, QIMR Berghofer Medical Research Institute, Herston, Queensland, Australia.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Wyssusek', 'Affiliation': ""Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia; Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Van Zundert', 'Affiliation': ""Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia; Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia.""}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Eley', 'Affiliation': ""Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia; Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia.""}]",British journal of anaesthesia,['10.1016/j.bja.2021.10.048']
3498,35034867,Qualitative Assessment of the Conservative Management of Nocturia with Standardised Written Materials for Lower Urinary Tract Symptoms in Men Treated in Primary Care.,"BACKGROUND


Many men prefer conservative treatment of lower urinary tract symptoms (LUTS) but education and self-help guidance are limited in primary care.
OBJECTIVE


To report qualitative interview findings for men reporting nocturia in a primary care setting for LUTS.
DESIGN, SETTING, AND PARTICIPANTS


TRIUMPH (Treating Urinary Symptoms in Men in Primary Healthcare) is a multicentre cluster randomised trial of standardised manualised care (a booklet delivered by a health care professional) versus usual care for LUTS. The participants (524 in the intervention arm and 553 in the usual care arm) were men presenting for primary care for LUTS at 30 general practice (GP) sites in the UK.
INTERVENTION


Delivery of a LUTS self-management booklet by health care staff in comparison to usual care for men with LUTS.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The qualitative component included 58 early-stage (0-3 mo after study enrolment) and 33 late-stage (3-9 mo later) interviews with participants to assess their experience of LUTS and conservative treatment in primary care. Purposive sampling was used to select participants for interview.
RESULTS AND LIMITATIONS


Nocturia is a common driver for seeking health care and is perceived by men as relatively acceptable to discuss. Information and self-help guidance were largely absent from descriptions of GP consultations, other than reducing evening caffeine and fluid intake. The TRIUMPH LUTS intervention booklet offers explanations and self-management guidance. Men with long-term disruptive symptoms, a perception that the booklet content was novel or worthwhile, and a belief that self-management might help, were more receptive to the intervention. In follow-up, improvements in nocturia were related to successful implementation of several aspects of the guidance. Most men were willing to complete a bladder diary, but some found it inconvenient, especially men in employment. The characteristics of the trial population mean that the findings may not apply to all men.
CONCLUSIONS


Reassuring men that nocturia is part of ageing without offering them information and support risks reinforcing the tendency to discount problematic LUTS. The trial booklet and the training of health care professionals support guidance on nocturia self-management, which is most effective for men receptive to this approach. However, the nature of the trial population means that the findings may not apply to all men.
PATIENT SUMMARY


Men are more comfortable in discussing waking at night to urinate than talking about other urinary symptoms with their GP. This problem should lead to a detailed discussion of all urinary symptoms rather than being thought of as a sign of ageing. An information booklet and nurse consultation helped many men to improve this symptom.",2022,"Information and self-help guidance were largely absent from descriptions of GP consultations, other than reducing evening caffeine and fluid intake.","['Men in Primary Healthcare', 'men reporting nocturia in a primary care setting for LUTS', 'Men Treated in Primary Care', '58 early-stage (0-3 mo after study enrolment) and 33 late-stage (3-9 mo later) interviews with participants to assess their experience of LUTS and conservative treatment in primary care', 'TRIUMPH ', 'participants (524 in the intervention arm and 553 in the usual care arm) were men presenting for primary care for LUTS at 30 general practice (GP) sites in the UK', 'men with LUTS', 'Men with long-term disruptive symptoms']","['LUTS self-management booklet', 'standardised manualised care (a booklet delivered by a health care professional) versus usual care for LUTS']",['nocturia'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C3643615', 'cui_str': 'Triumph'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0028734', 'cui_str': 'Nocturia'}]",,0.0347928,"Information and self-help guidance were largely absent from descriptions of GP consultations, other than reducing evening caffeine and fluid intake.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Olaniyi', 'Affiliation': 'Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Cotterill', 'Affiliation': 'School of Health and Social Wellbeing, University of the West of England, Bristol, UK.'}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Drake', 'Affiliation': 'Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK; Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. Electronic address: marcus.drake@bui.ac.uk.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Frost', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Ridd', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Robles', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Taylor', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Worthington', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Wheeler', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]",European urology focus,['10.1016/j.euf.2022.01.003']
3499,35015087,[Randomized phase II study of PET response-adapted combined multimodal therapy for esophageal cancer: results of the CALGB 80803 (Alliance) trial].,,2022,,['esophageal cancer'],['PET response-adapted combined multimodal therapy'],[],"[{'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}]","[{'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]",[],,0.0422317,,"[{'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Bauer', 'Affiliation': 'Universitätsklinikum Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Deutschland.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Lang', 'Affiliation': 'Universitätsklinikum Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Deutschland. Kristin.Lang@med.uni-heidelberg.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-021-01898-8']
3500,35015083,Interplay of Dinner Timing and MTNR1B Type 2 Diabetes Risk Variant on Glucose Tolerance and Insulin Secretion: A Randomized Crossover Trial.,"OBJECTIVE


We tested whether the concurrence of food intake and elevated concentrations of endogenous melatonin, as occurs with late eating, results in impaired glucose control, in particular in carriers of the type 2 diabetes-associated G allele in the melatonin receptor-1B gene (MTNR1B).
RESEARCH DESIGN AND METHODS


In a Spanish natural late-eating population, a randomized, crossover study was performed. Each participant (n = 845) underwent two evening 2-h 75-g oral glucose tolerance tests following an 8-h fast: an early condition scheduled 4 h prior to habitual bedtime (""early dinner timing"") and a late condition scheduled 1 h prior to habitual bedtime (""late dinner timing""), simulating an early and a late dinner timing, respectively. Differences in postprandial glucose and insulin responses between early and late dinner timing were determined using incremental area under the curve (AUC) calculated by the trapezoidal method.
RESULTS


Melatonin serum levels were 3.5-fold higher in the late versus early condition, with late dinner timing resulting in 6.7% lower insulin AUC and 8.3% higher glucose AUC. The effect of late eating impairing glucose tolerance was stronger in the MTNR1B G-allele carriers than in noncarriers. Genotype differences in glucose tolerance were attributed to reductions in β-cell function (P for interaction, Pint glucose area under the curve = 0.009, Pint corrected insulin response = 0.022, and Pint disposition index = 0.018).
CONCLUSIONS


Concurrently high endogenous melatonin and carbohydrate intake, as typical for late eating, impairs glucose tolerance, especially in MTNR1B G-risk allele carriers, attributable to insulin secretion defects.",2022,"Genotype differences in glucose tolerance were attributed to reductions in β-cell function (P for interaction, Pint glucose area under the curve = 0.009, Pint corrected insulin response = 0.022, and Pint Disposition Index = 0.018).
",['Spanish natural late-eating population'],"['two evening 2-h 75-g oral glucose tolerance tests following an 8-h fast: an early condition scheduled 4 h prior to habitual bedtime (""early dinner timing"") and a late condition scheduled 1 h prior to habitual bedtime (""late dinner timing']","['β-cell function', 'Melatonin serum levels', 'glucose tolerance', 'postprandial glucose and insulin responsesbetween early and late dinner timing', 'Glucose Tolerance and Insulin Secretion']","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0700308', 'cui_str': 'Protium'}]","[{'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}]",845.0,0.0470791,"Genotype differences in glucose tolerance were attributed to reductions in β-cell function (P for interaction, Pint glucose area under the curve = 0.009, Pint corrected insulin response = 0.022, and Pint Disposition Index = 0.018).
","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Garaulet', 'Affiliation': 'Department of Physiology, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Lopez-Minguez', 'Affiliation': 'Department of Physiology, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Hassan S', 'Initials': 'HS', 'LastName': 'Dashti', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Vetter', 'Affiliation': 'Broad Institute, Cambridge, MA.'}, {'ForeName': 'Antonio Miguel', 'Initials': 'AM', 'LastName': 'Hernández-Martínez', 'Affiliation': 'Department of Endocrinology and Nutrition, ""Virgen Arrixaca"" Hospital and University of Murcia, Murcia, Spain.'}, {'ForeName': 'Millán', 'Initials': 'M', 'LastName': 'Pérez-Ayala', 'Affiliation': 'Department of Clinical Analysis, Virgen de la Arrixaca University Hospital, Murcia, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Baraza', 'Affiliation': 'Department of Physiology, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Florez', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Frank A J L', 'Initials': 'FAJL', 'LastName': 'Scheer', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Saxena', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}]",Diabetes care,['10.2337/dc21-1314']
3501,35018575,Effect of eccentric and concentric contraction mode on myogenic regulatory factors expression in human vastus lateralis muscle.,"Skeletal muscle contractions are caused to release myokines by muscle fiber. This study investigated the myogenic regulatory factors, as MHC I, IIA, IIX, Myo-D, MRF4, Murf, Atrogin-1, Decorin, Myonection, and IL-15 mRNA expression in the response of eccentric vs concentric contraction. Eighteen healthy men were randomly divided into two eccentric and concentric groups, each of 9 persons. Isokinetic contraction protocols included maximal single-leg eccentric or concentric knee extension tasks at 60°/s with the dominant leg. Contractions consisted of a maximum of 12 sets of 10 reps, and the rest time between each set was 30 s. The baseline biopsy was performed 4 weeks before the study, and post-test biopsies were taken immediately after exercise protocols from the vastus lateralis muscle. The gene expression levels were evaluated using Real-Time PCR methods. The eccentric group showed a significantly lower RPE score than the concentric group (P ≤ 0.05). A significant difference in MyoD, MRF4, Myonection, and Decorin mRNA, were observed following eccentric or concentric contractions (P ≤ 0.05). The MHC I, MHC IIA, IL-15 mRNA has been changed significantly compared to the pre-exercise in the concentric group (P ≤ 0.05). While only MHC IIX and Atrogin-1 mRNA changed significantly in the eccentric group (P ≤ 0.05). Additionally, the results showed a significant difference in MyoD, MRF4, IL-15, and Decorin at the follow-up values between eccentric or concentric groups (P ≤ 0.05). Our findings highlight the growing importance of elucidating the different responses of muscle growth factors associated with a myogenic activity such as MHC IIA, Decorin, IL-15, Myonectin, Decorin, MuRF1, and MHC IIX mRNA in following various types of exercise.",2022,"A significant difference in MyoD, MRF4, Myonection, and Decorin mRNA, were observed following eccentric or concentric contractions (P ≤ 0.05).","['human vastus lateralis muscle', 'Eighteen healthy men']",['eccentric and concentric contraction mode'],"['eccentric or concentric contractions', 'MyoD, MRF4, IL-15, and Decorin', 'maximal single-leg eccentric or concentric knee extension tasks', 'RPE score', 'MyoD, MRF4, Myonection, and Decorin mRNA', 'MHC IIX and Atrogin-1 mRNA', 'gene expression levels']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0083504', 'cui_str': 'myogenic factor 6'}, {'cui': 'C0254610', 'cui_str': 'Interleukin 15'}, {'cui': 'C0057252', 'cui_str': 'Bone Proteoglycan II'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0024518', 'cui_str': 'Major histocompatibility complex'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",18.0,0.033971,"A significant difference in MyoD, MRF4, Myonection, and Decorin mRNA, were observed following eccentric or concentric contractions (P ≤ 0.05).","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Sabouri', 'Affiliation': 'Department of Exercise Physiology & Health Science, University of Tehran, Tehran, Iran. mostafasaboory@ut.ac.ir.'}, {'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Taghibeikzadehbadr', 'Affiliation': 'Department of Exercise Physiology & Health Science, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Shabkhiz', 'Affiliation': 'Department of Exercise Physiology & Health Science, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Izanloo', 'Affiliation': 'Department of Sport Science, Faculty of Human Science, University of Bojnord, Bojnord, Iran.'}, {'ForeName': 'Farahnaz Amir', 'Initials': 'FA', 'LastName': 'Shaghaghi', 'Affiliation': 'Department of Exercise Physiology & Health Science, University of Tehran, Tehran, Iran. famirshaghaghi@ut.ac.ir.'}]",Journal of muscle research and cell motility,['10.1007/s10974-021-09613-x']
3502,34949626,Development of an optimised physiotherapist-led treatment protocol for lateral elbow tendinopathy: a consensus study using an online nominal group technique.,"OBJECTIVES


There are a wide range of physiotherapy treatment options for people with lateral elbow tendinopathy (LET); however, previous studies have reported inconsistent approaches to treatment and a lack of evidence demonstrating clinical effectiveness. This study aimed to combine the best available research evidence with stakeholder perspectives to develop key components of an optimised physiotherapist-led treatment protocol for testing in a future randomised controlled trial (RCT).
DESIGN


Online consensus groups using nominal group technique (NGT), a systematic approach to building consensus using structured multistage meetings.
SETTING


UK National Health Service (NHS).
PARTICIPANTS


10 physiotherapists with special interest in LET, 2 physiotherapy service managers and 3 patients who had experienced LET.
INTERVENTIONS


Two consensus groups were conducted; the first meeting focused on agreeing the types of interventions to be included in the optimised treatment protocol; the second meeting focused on specific details of intervention delivery. Participants were sent an evidence summary of available treatments for LET prior to the first meeting. All treatment options were discussed before anonymous voting and ranking of priority. Consensus for inclusion of each treatment option was set at ≥70% based on OMERACT guidelines. Options with 30%-69% agreement were discussed again, and a second vote was held, allowing for a change of opinion.
RESULTS


The optimised physiotherapist-led treatment package included: advice and education, exercise therapy and orthotics. Specific components for each of these interventions were also agreed such as: condition-specific advice, health-promotion advice, exercise types, exercise into 'acceptable' levels of pain, exercise dosage and type of orthoses. Other treatment options including electrotherapy, acupuncture and manual therapy were excluded.
CONCLUSION


An optimised physiotherapist-led treatment protocol for people with LET was successfully developed using an online NGT consensus approach. This intervention is now ready for testing in a future pilot/feasibility RCT to contribute much needed evidence about the treatment of LET.
TRIAL REGISTRATION NUMBER


This is the pre-cursor to the OPTimisE Pilot and Feasibility Randomised Controlled Trial. Registration: https://www.isrctn.com/ISRCTN64444585.",2021,An optimised physiotherapist-led treatment protocol for people with LET was successfully developed using an online NGT consensus approach.,"['UK National Health Service (NHS', '10 physiotherapists with special interest in LET, 2 physiotherapy service managers and 3 patients who had experienced LET', 'lateral elbow tendinopathy', 'people with lateral elbow tendinopathy (LET']","['nominal group technique (NGT', 'electrotherapy, acupuncture and manual therapy', 'physiotherapist-led treatment package included: advice and education, exercise therapy and orthotics', 'optimised physiotherapist-led treatment protocol']",[],"[{'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C4277745', 'cui_str': 'Elbow Tendinopathy'}, {'cui': 'C0587629', 'cui_str': 'Physiotherapy service'}, {'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1276791', 'cui_str': 'Education assistance'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]",[],10.0,0.0725929,An optimised physiotherapist-led treatment protocol for people with LET was successfully developed using an online NGT consensus approach.,"[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bateman', 'Affiliation': 'Derby Shoulder Unit, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK marcus.bateman@nhs.net.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'School of Medicine, Keele University, Stoke-on-Trent, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Littlewood', 'Affiliation': 'Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Hill', 'Affiliation': 'School of Medicine, Keele University, Stoke-on-Trent, UK.'}]",BMJ open,['10.1136/bmjopen-2021-053841']
3503,35017008,Nonrandomized Comparison of Efficacy and Side Effects of Bicalutamide Compared With Luteinizing Hormone-Releasing Hormone (LHRH) Analogs in Combination With Radiation Therapy in the CHHiP Trial.,"PURPOSE


CHHiP is a randomized trial evaluating moderately hypofractionated radiation therapy for treatment of localized prostate cancer. Of all participants, 97% of them had concurrent short-course hormone therapy (HT), either luteinizing hormone-releasing hormone analog (LHRHa) or 150 mg of bicalutamide daily. This exploratory analysis compares efficacy and side effects in a nonrandomized comparison.
METHODS AND MATERIALS


In our study, 2700 patients received LHRHa and 403 received bicalutamide. The primary endpoint was biochemical/clinical failure. Groups were compared with Cox regression adjusted for various prognostic factors and stratified by radiation therapy dose. A key secondary endpoint was erectile dysfunction (ED) assessed by clinicians (using scores from Late Effects on Normal Tissues: Subjective/Objective/Management [LENT-SOM] subjective erectile function for vaginal penetration) and patients (single items within the University of California-Los Angeles Prostate Cancer Index [UCLA PCI] and Expanded Prostate Cancer Index Composite [EPIC]-50 questionnaires) at 2 years and compared between HT regimens by χ 2  trend test.
RESULTS


Bicalutamide patients were significantly younger (median 67 vs 69 years LHRHa). Median follow-up was 9.3 years. There was no difference in biochemical or clinical failure with an adjusted hazard ratio or 0.97 (95% confidence interval, 0.77-1.23; P = .8). At 2 years, grade ≥2 LENT-SOM ED was reported in significantly more LHRHa patients (313 out of 590; 53%) versus bicalutamide (17 out of 68; 25%) (P < .0001). There were no differences in ED seen with UCLA-PCI and EPIC-50 questionnaires.
CONCLUSIONS


In this nonrandomized comparison, there was no evidence of a difference in efficacy according to type of HT received. Bicalutamide preserved clinician assessed (LENT-SOM) erectile function at 2 years but patient-reported outcomes were similar between groups.",2022,There was no difference in BCF with adjusted hazard ratio 0.97 (95%CI 0.77-1.23; p=0.8).,"['2700 pts received', '97% of participants had concurrent short course hormone therapy (HT), either', 'localised prostate cancer']","['bicalutamide', 'Bicalutamide', 'LHRHa, 403 bicalutamide', 'LHRH analogues', 'Luteinising Hormone Releasing Hormone analogues (LHRHa) or bicalutamide', 'XXXXX', 'hypofractionated radiotherapy']","['BCF', 'biochemical/clinical failure (BCF', 'efficacy and side effects', 'grade≥2 LENT-SOM ED', 'erectile dysfunction (ED) assessed by clinicians (LENT-SOM subjective erectile function for vaginal penetration) and patients (single items within UCLA-PCI and EPIC-50 questionnaires']","[{'cui': 'C4517675', 'cui_str': '2700'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0285590', 'cui_str': 'bicalutamide'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037640', 'cui_str': 'Somalia'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0556623', 'cui_str': 'Vaginal penetration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.191627,There was no difference in BCF with adjusted hazard ratio 0.97 (95%CI 0.77-1.23; p=0.8).,"[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Tree', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, United Kingdom; Institute of Cancer Research, London, United Kingdom. Electronic address: Alison.tree@icr.ac.uk.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Griffin', 'Affiliation': 'Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Syndikus', 'Affiliation': 'Clatterbridge Cancer Centre, Wirral, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Royal Preston Hospital, Preston, United Kingdom.'}, {'ForeName': 'Ananya', 'Initials': 'A', 'LastName': 'Choudhury', 'Affiliation': 'University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': 'Beatson Oncology Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ferguson', 'Affiliation': 'Weston Park Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Khoo', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, United Kingdom; Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Zafar', 'Initials': 'Z', 'LastName': 'Malik', 'Affiliation': 'Whiston Hospital, Merseyside, United Kingdom.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': ""O'Sullivan"", 'Affiliation': ""Patrick G. Johnston Centre for Cancer Research, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Panades', 'Affiliation': 'Lincoln County Hospital, Lincoln, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, United Kingdom; Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Rimmer', 'Affiliation': ""Addenbrooke's Hospital, Cambridge, United Kingdom.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Scrase', 'Affiliation': 'Ipswich Hospital, Ipswich, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Cardiff University/Velindre Cancer Centre, Cardiff, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dearnaley', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, United Kingdom; Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.12.160']
3504,35017010,Arterial responses to infusion of glucagon-like peptide-1 in humans: A randomized trial study.,"Glucagon-like-peptide-1 (GLP-1) is an incretin hormone implicated in several metabolic and neurological disorders. GLP-1 induces vasodilation and increases blood flow in the peripheral circulation. Whether GLP-1 alters cerebral hemodynamics in humans is yet to be elucidated. In a crossover, double-blind, placebo-controlled, and randomized design, 21 healthy volunteers were assigned to receive intravenous GLP-1 infusion (2.5 pmol/kg/min) or placebo over 20 min on two different days separated by at least one week. We used a noninvasive, well-validated transcranial doppler (TCD) and ultrasound dermascan to reveal the effect of GLP-1 on intra- and extracerebral arteries. The mean blood flow velocity in the middle cerebral artery (V MCA ), the diameter of the superficial temporal artery (STA) and radial artery (RA), and facial skin blood flow were measured. In addition, we documented headache and its associated symptoms during and after infusion. Twenty participants were included in the final analysis. We found no difference in the V MCA  (P = 0.227), diameter of the STA (P = 0.096) and the RA (P = 0.221) and facial blood flow (P = 0.814) after GLP-1 compared to placebo. There were no differences in HR, SAT, EtCO 2 , or RF (P > 0.05) on the GLP-1 day compared to the placebo day. We found no differences in the incidence of headache after GLP-1 (n = 10) compared to placebo (n = 7) (P = 0.250). GLP-1 infusion did not affect cerebral hemodynamics and induce headache in humans. Further preclinical studies with validated methods are required to determine if intra - and extracerebral vasculature express GLP-1Rs in humans.",2022,"There were no differences in HR, SAT, EtCO 2 , or RF (P > 0.05) on the GLP-1 day compared to the placebo day.","['21 healthy volunteers', 'Twenty participants were included in the final analysis', 'humans']","['placebo', 'Glucagon-like-peptide-1 (GLP-1', 'GLP-1', 'GLP-1 infusion', 'intravenous GLP-1 infusion', 'glucagon-like peptide-1']","['blood flow', 'diameter of the superficial temporal artery (STA) and radial artery (RA), and facial skin blood flow', 'HR, SAT, EtCO 2 , or RF', 'incidence of headache', 'cerebral hemodynamics and induce headache', 'mean blood flow velocity', 'diameter of the STA', 'facial blood flow']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0226130', 'cui_str': 'Structure of superficial temporal artery'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",21.0,0.233687,"There were no differences in HR, SAT, EtCO 2 , or RF (P > 0.05) on the GLP-1 day compared to the placebo day.","[{'ForeName': 'Hashmat', 'Initials': 'H', 'LastName': 'Ghanizada', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Rune Häckert', 'Initials': 'RH', 'LastName': 'Christensen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Mohammad Al-Mahdi', 'Initials': 'MA', 'LastName': 'Al-Karagholi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Fatima Azzahra', 'Initials': 'FA', 'LastName': 'Elbahi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Hande', 'Initials': 'H', 'LastName': 'Coskun', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Danish Headache Knowledge Center, Rigshospitalet-Glostrup, Valdemar Hansens Vej 5, Glostrup, Denmark. Electronic address: ashina@dadlnet.dk.'}]",Peptides,['10.1016/j.peptides.2022.170736']
3505,35018417,Continuous Glucose Monitoring Initiation Within First Year of Type 1 Diabetes Diagnosis Is Associated With Improved Glycemic Outcomes: 7-Year Follow-Up Study.,"OBJECTIVE


To evaluate long-term glycemic outcomes of continuous glucose monitoring (CGM) initiation within the first year of type 1 diabetes diagnosis.
RESEARCH DESIGN AND METHODS


Patients with type 1 diabetes (N = 396) were divided into three groups: 1) CGM (CGM use within 1 year of diabetes diagnosis and continued through the study), 2) no-CGM (no CGM use throughout the study), and 3) new-CGM (CGM use after 3 years since diabetes diagnosis). Patients were followed up to 7 years.
RESULTS


A1c was significantly lower in the CGM compared with the no-CGM group throughout 7 years of follow-up (least squares mean A1c values: 6 months, 7.3% vs. 8.1%; 1 year, 7.4% vs. 8.6%; 2 years, 7.7% vs. 9.1%; 3 years, 7.6% vs. 9.3%; 4 years, 7.4% vs. 9.6%; 5 years, 7.6% vs. 9.7%; 6 years, 7.5% vs. 10.0%; and 7 years, 7.6% vs. 9.8%; for all, P < 0.001) adjusting for age at diagnosis, sex, and insulin delivery method.
CONCLUSIONS


CGM initiation within first year of type 1 diabetes diagnosis results in long-term improvement in A1c.",2022,"RESULTS


A1c was significantly lower in the CGM compared with the no-CGM group throughout 7 years of follow-up (least squares",['Patients with type 1 diabetes (N = 396'],"['Continuous Glucose Monitoring Initiation', 'CGM (CGM use within 1 year of diabetes diagnosis and continued through the study); 2) no-CGM (no CGM use throughout the study); and 3) new-CGM (CGM', 'continuous glucose monitoring (CGM) initiation', 'CGM']",['Glycemic Outcomes'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C5191354', 'cui_str': '396'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}]",396.0,0.0249914,"RESULTS


A1c was significantly lower in the CGM compared with the no-CGM group throughout 7 years of follow-up (least squares","[{'ForeName': 'Anagha', 'Initials': 'A', 'LastName': 'Champakanath', 'Affiliation': ''}, {'ForeName': 'Halis Kaan', 'Initials': 'HK', 'LastName': 'Akturk', 'Affiliation': ''}, {'ForeName': 'G Todd', 'Initials': 'GT', 'LastName': 'Alonso', 'Affiliation': ''}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Snell-Bergeon', 'Affiliation': ''}, {'ForeName': 'Viral N', 'Initials': 'VN', 'LastName': 'Shah', 'Affiliation': ''}]",Diabetes care,['10.2337/dc21-2004']
3506,35019221,"Efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation: Chinese sub-cohort analysis of a phase III, randomized, double-blind, placebo-controlled trial.","OBJECTIVE


To conduct a sub-cohort analysis to evaluate the efficacy and safety of linaclotide in Chinese patients with constipation-predominant irritable bowel syndrome (IBS-C) using data from a completed trial (NCT01880424).
METHODS


In this phase III, double-blind, placebo-controlled trial, IBS-C patients were randomized to receive linaclotide (290 μg/d) or placebo for 12 weeks. Efficacy was assessed with two co-primary responder end-points (12-wk abdominal pain/discomfort: ≥30% reduction in either score with neither deteriorating from baseline for ≥6 wks; 12-wk IBS degree of relief: score ≤2 for ≥ 6 wks), seven secondary endpoints and several additional end-points.
RESULTS


In total, 659 Chinese IBS-C patients received linaclotide (n = 327) or placebo (n = 332). The 12-week abdominal pain/discomfort end-point was met in 62.1% and 53.3% of the linaclotide-treated and placebo-treated patients, respectively (odds ratio [OR] 1.43, 95% confidence interval [CI] 1.05-1.96, P = 0.023); the 12-week IBS degree of relief end-point was achieved in 32.7% and 16.9% of the patients treated with linaclotide and placebo, respectively (OR 2.40, 95% CI 1.66-3.47, P < 0.001). The linaclotide-treated patients had a shorter time to the first spontaneous bowel movement than the placebo-treated patients (23.6 h vs 43.7 h, P < 0.001). Linaclotide produced significantly greater improvement than placebo in all secondary end-points from the first 2 weeks (all P < 0.001). Diarrhea was reported in 8.3% of linaclotide-treated patients and 1.2% of placebo-treated patients.
CONCLUSION


Linaclotide (290 μg/d) was efficacious and well-tolerated in Chinese IBS-C patients with a rapid onset of effect.",2022,Linaclotide demonstrated significantly greater improvement than placebo in all secondary endpoints from the first two weeks (P<0.001 for all).,"['659 Chinese patients with IBS-C', 'patients with IBS-C', 'Patients with Irritable Bowel Syndrome with Constipation', 'Chinese patients with IBS-C', 'Asian patients']","['placebo', 'Linaclotide', 'linaclotide', 'Placebo']","['efficacy and safety of linaclotide', 'shorter median time to the first SBM', 'efficacious and well-tolerated', '12-week IBS degree of relief endpoint', 'Efficacy', 'Diarrhea', '12-week abdominal pain/discomfort endpoint', 'Efficacy and Safety']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2000261', 'cui_str': 'linaclotide'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2000261', 'cui_str': 'linaclotide'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",659.0,0.613739,Linaclotide demonstrated significantly greater improvement than placebo in all secondary endpoints from the first two weeks (P<0.001 for all).,"[{'ForeName': 'Li Hua', 'Initials': 'LH', 'LastName': 'Peng', 'Affiliation': 'Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jing Yuan', 'Initials': 'JY', 'LastName': 'Fang', 'Affiliation': 'State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Gastroenterology & Hepatology, Ministry of Health, Division of Gastroenterology and Hepatology, Shanghai Cancer Institute, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Dai', 'Affiliation': 'Department of Gastroenterology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Xi Zhong', 'Initials': 'XZ', 'LastName': 'Shen', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'You Lin', 'Initials': 'YL', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yun Sheng', 'Initials': 'YS', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}]",Journal of digestive diseases,['10.1111/1751-2980.13081']
3507,35020026,Allogeneic platelet-derived growth factors local injection in treatment of tennis elbow: a prospective randomized controlled study.,"PURPOSE


The purpose of this study aimed to evaluate the efficacy of local injection of allogeneic platelet-derived growth factors in treatment of patients with tennis elbow.
PATIENTS AND METHODS


This study included 120 tennis elbow patients randomly divided into two groups. The patients were locally injected with allogeneic growth factors (treatment group) or with normal saline (control group). The outcomes were assessed using Patient-Related Tennis Elbow Evaluation (PRTEE) and quick Disabilities of the Arm, Shoulder and Hand (qDASH) scales. The clinical outcomes were accordingly classified as excellent, good and poor. The patient's satisfaction and adverse effects were also recorded.
RESULTS


There was no statistically significant difference between the two groups regarding the age, gender, dominant arm or the pre-injection scores. At three month follow-up, the reductions in the mean PRTEE and qDASH scores were 88.7% and 70.6% in the treatment group versus 21.8% and 14.9% in the control group, respectively. At the last follow-up, the outcomes in the treatment group were excellent in 85% of patients and good in 15%, versus 8% and 32% in the control group. Overall, 95% were satisfied in the treatment group compared to 25% in control group. Forty patients in the treatment group experienced mild transient post-injection pain.
CONCLUSION


This study strongly suggests that local injection of allogeneic platelet-derived growth factors could be a promising safe treatment option for tennis elbow with significant pain relief, functional improvement and patient's satisfaction. Yet, additional larger studies are needed to assess the durability of these outcomes.",2022,"There was no statistically significant difference between the two groups regarding the age, gender, dominant arm or the pre-injection scores.","['120 tennis elbow patients randomly divided into two groups', 'patients with tennis elbow', 'tennis elbow']","['allogeneic growth factors (treatment group) or with normal saline (control group', 'allogeneic platelet-derived growth factors', 'Allogeneic platelet-derived growth factors local injection']","['mean PRTEE and qDASH scores', ""patient's satisfaction and adverse effects"", 'mild transient post-injection pain', 'Patient-Related Tennis Elbow Evaluation (PRTEE) and quick Disabilities of the Arm, Shoulder and Hand (qDASH) scales']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032200', 'cui_str': 'Platelet-derived growth factor'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",120.0,0.0302349,"There was no statistically significant difference between the two groups regarding the age, gender, dominant arm or the pre-injection scores.","[{'ForeName': 'Mahmoud Ibrahim', 'Initials': 'MI', 'LastName': 'Kandil', 'Affiliation': 'Department of Orthopaedic Surgery, Benha Faculty of Medicine, Farid Nada Street, Kalyubia, Banha, Post Office, 13518, Egypt.'}, {'ForeName': 'Abdel-Salam Abdel-Aleem', 'Initials': 'AA', 'LastName': 'Ahmed', 'Affiliation': 'Department of Orthopaedic Surgery, Benha Faculty of Medicine, Farid Nada Street, Kalyubia, Banha, Post Office, 13518, Egypt. salam_ilizarov@yahoo.com.'}, {'ForeName': 'Rasha Shaker', 'Initials': 'RS', 'LastName': 'Eldesouky', 'Affiliation': 'Community Medicine, Faculty of Medicine, Benha University, Banha, Egypt.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Eltregy', 'Affiliation': 'Department of Orthopaedic Surgery, Benha Faculty of Medicine, Farid Nada Street, Kalyubia, Banha, Post Office, 13518, Egypt.'}]",International orthopaedics,['10.1007/s00264-022-05300-9']
3508,35020250,"Efficacy and safety of two hyaluronic acid fillers with different injection depths for the correction of moderate-to-severe nasolabial folds: A 52-week, prospective, randomized, double-blinded study in a Chinese population.","BACKGROUND


Hyaluronic acid (HA) fillers are known to be effective for the correction of facial wrinkles and folds, but there is no clinical study that compares the efficacy of small-to-medium-particle HA fillers and large-particle HA fillers for the correction of nasolabial folds (NLFs). Moreover, injection depth also plays an important role in the correction of NLFs as well as improvement of facial aesthetics.
OBJECTIVES


To assess the efficacy, safety, and durability of a small-to-medium-particle HA filler, Restylane, and a large-particle HA filler, Yishumei, as well as the effect of injection depth in the correction of moderate-to-severe NLFs and facial aesthetics in a Chinese population.
METHODS


This 52-week, prospective, randomized, double-blind study enrolled 100 participants with moderate-to-severe NLFs. The participants were randomized to receive either Restylane (Group A) or Yishumei (Group B). Group A and Group B were further randomly divided into a superficial injection group (Group A1 & B1) and a deep injection group (Group A2&B2) according to injection depth. Improvement in the Wrinkle Severity Rating Scale (WSRS) score and Global Aesthetic Improvement Scale (GAIS) and participants' satisfaction were evaluated as endpoints. All adverse events were monitored throughout the study.
RESULTS


The treatments were well tolerated by all the participants. All four groups showed a reduction in their mean WSRS scores and GAIS scores by week 12. At week 24, the WSRS and GAIS scores did not change in Group A1 and A2, while participants in Group B1 and Group B2 had higher WSRS and GAIS scores than those in the previous weeks. By week 52, the WSRS scores in all the groups returned to almost baseline levels. The mean FACE-Q scores increased compared with the baseline scores in all groups through week 24. Most participants were satisfied with their treatment, and no meaningful differences were found between the fillers in terms of participant satisfaction. The most common adverse events were swelling, redness, and tenderness at the injection site, but they resolved spontaneously without treatment.
CONCLUSION


The two HA fillers had good therapeutic effect on NLFs in the early stage of treatment, but Restylane had a more prolonged effect. Moreover, compared with the superficial injection, the deep injection provided slight midface lifting and improved facial aesthetics.",2022,"Most participants were satisfied with their treatment, and no meaningful differences were found between the fillers in terms of participant satisfaction.","['Chinese population', 'moderate-to-severe nasolabial folds', '100 participants with moderate-to-severe NLFs']","['Hyaluronic acid (HA) fillers', 'Restylane (Group A) or Yishumei', 'hyaluronic acid fillers']","['Efficacy and safety', 'WSRS scores', 'slight midface lifting and improved facial aesthetics', 'swelling, redness, and tenderness', 'WSRS and GAIS scores', 'mean FACE-Q scores', 'mean WSRS scores and GAIS scores', ""Wrinkle Severity Rating Scale (WSRS) score and Global Aesthetic Improvement Scale (GAIS) and participants' satisfaction"", 'tolerated', 'good therapeutic effect on NLFs', 'efficacy, safety, and durability']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0221328', 'cui_str': 'Nasolabial sulcus structure'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0729441', 'cui_str': 'Filler'}, {'cui': 'C1101698', 'cui_str': 'Restylane'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2937276', 'cui_str': 'Slight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0221328', 'cui_str': 'Nasolabial sulcus structure'}]",100.0,0.106514,"Most participants were satisfied with their treatment, and no meaningful differences were found between the fillers in terms of participant satisfaction.","[{'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Dermatology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Dermatology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': ""Department of Dermatology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': ""Department of Dermatology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Hongyue', 'Initials': 'H', 'LastName': 'Diao', 'Affiliation': ""Department of Dermatology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': ""Department of Outpatient Office, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shuqin', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Dermatology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.14744']
3509,35030090,The Efficacy of a Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Controlled Trial in the Context of COVID-19.,"BACKGROUND


Adolescents contribute slightly less than one-third of all new HIV infections in sub-Saharan Africa. There is a need for more effective intervention approaches to help young adolescents safely navigate through adolescence and into adulthood. We are assessing the efficacy of Tumaini, a smartphone game designed to prevent HIV among young Africans. Against the background of COVID-19, meaningful alteration of the research protocol was necessary to ensure successful implementation and retention of the study participants in ongoing research.
OBJECTIVE


The objective of our protocol is to determine (1) if Tumaini delays sexual debut and increases condom use at first sex and (2) whether it influences behavioral mediators of early and unprotected sex.
METHODS


Participants were recruited from Kisumu County in Western Kenya. This study is a 2-arm, individual-randomized controlled trial that enrolled 1004 adolescents aged between 12 years and 15 years. The intervention arm participants are playing Tumaini, while the control arm is provided with Brainilis, a commercially available control game. The study period will last 45 months. At baseline, participants in both arms completed a baseline survey and biological testing for HIV and herpes simplex virus, type 2 (HSV-2); participants will have annual game play periods in years 1-3. They will also complete a total of 12 follow-up surveys. At endline, repeat biological testing will be conducted. Protocol adaptations were necessitated by the COVID-19 pandemic and implemented in accordance with local public health guidelines.
RESULTS


Participants were enrolled between October 2020 and November 2020. We plan to complete study procedures in September 2024. The enrolled participant sample was 50.1% (499/996) female and had a mean age of 14.0 (SD 0.6) years.
CONCLUSIONS


This ongoing research demonstrates that, with appropriate revisions to planned protocol activities guided by the need to maintain study integrity, protect both study participants and staff, and adhere to institutional review board and local health authority guidelines, human subject research is possible in the context of a global pandemic. If the trial demonstrates efficacy, Tumaini would provide an alternative, remote means of delivering age-appropriate education to adolescents on safer sex, HIV prevention, and effective life skills on a highly scalable, low-cost, and culturally adaptable platform.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04437667; https://clinicaltrials.gov/ct2/show/NCT04437667.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/35117.",2022,"If the trial demonstrates efficacy, Tumaini would provide an alternative, remote means of delivering age-appropriate education to pre-adolescents on safer sex, HIV prevention and effective life skills on a highly scalable, low cost and culturally adaptable platform.
","['Participants were recruited from Kisumu County, in Western Kenya', 'enrolled 1,004 adolescents aged between 12 and 15 years', 'HIV among Young Africans', 'Participants were enrolled between October 2020 and November 2020', 'young Africans', 'Enrolled participant sample was 50.1% female (n=499) and had a mean age of 14.0 years (SD=0.6 years']","['playing Tumaini, while the control arm are provided with Brainilis, a commercially available control game', 'Smartphone Game']",[],"[{'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]",[],1004.0,0.348498,"If the trial demonstrates efficacy, Tumaini would provide an alternative, remote means of delivering age-appropriate education to pre-adolescents on safer sex, HIV prevention and effective life skills on a highly scalable, low cost and culturally adaptable platform.
","[{'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Mudhune', 'Affiliation': 'HIV Research Division, Center for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Sabben', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ondenge', 'Affiliation': 'HIV Research Division, Center for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Mbeda', 'Affiliation': 'HIV Research Division, Center for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Morales', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Lyles', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Arego', 'Affiliation': 'HIV Research Division, Center for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ndivo', 'Affiliation': 'HIV Research Division, Center for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Bednarczyk', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Komro', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Winskell', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}]",JMIR research protocols,['10.2196/35117']
3510,35027324,"Phase III randomized trial comparing systemic versus intra-arterial oxaliplatin, combined with LV5FU2 +/- irinotecan and a targeted therapy, in the first-line treatment of metastatic colorectal cancer restricted to the liver (OSCAR): PRODIGE 49.","INTRODUCTION


In patients with unresectable liver metastases from colorectal cancer (CRCLM), systemic doublet or triplet chemotherapy and targeted therapy is considered a standard first-line treatment. Hepatic arterial infusion of oxaliplatin (HAI-ox) generates a high response rate, but this still needs to be confirmed in a randomized trial. We incorporated HAI-ox in doublet or triplet + targeted therapy to validate its efficacy.
AIM


The OSCAR study is an ongoing randomized phase III trial comparing FOLFOX + targeted therapy according to RAS status, or FOLFOXIRI + bevacizumab in patients eligible for triplet therapy, with the same regimen but with HAI-ox instead of IV-ox as the first-line treatment for CRCLM.
MATERIALS AND METHODS


Main eligibility criteria are colorectal cancer, unresectable liver metastasis, no extra-hepatic metastases except pulmonary nodules if ≤3 and <10 mm, ECOG performance status 0 or 1.
ENDPOINT


The primary endpoint is progression-free survival (PFS). A difference of 4 months for the median PFS in favor of HAI-ox is expected (HR = 0.73). Secondary endpoints include overall survival, overall response rate, secondary liver resection, safety, and quality of life.
CONCLUSION


This study is planned to include 348 patients to demonstrate the superiority of HAI-ox over systemic oxaliplatin in first-line CRCLM treatment (NCT02885753).",2022,A difference of 4 months for the median PFS in favor of HAI-ox is expected (HR = 0.73).,"['348 patients to demonstrate the superiority of HAI-ox over systemic oxaliplatin in first-line CRCLM treatment (NCT02885753', 'Main eligibility criteria are colorectal cancer, unresectable liver metastasis, no extra-hepatic metastases except pulmonary nodules if ≤3 and <10\xa0mm, ECOG performance status 0 or 1', 'patients eligible for triplet therapy, with the same regimen but with HAI-ox instead of IV-ox as the first-line treatment for CRCLM', 'metastatic colorectal cancer restricted to the liver (OSCAR', 'patients with unresectable liver metastases from colorectal cancer (CRCLM']","['FOLFOX', 'irinotecan', 'oxaliplatin (HAI-ox', 'FOLFOXIRI\xa0+\xa0bevacizumab', 'systemic versus intra-arterial oxaliplatin, combined with LV5FU2 ']","['progression-free survival (PFS', 'overall survival, overall response rate, secondary liver resection, safety, and quality of life']","[{'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0034079', 'cui_str': 'Nodule of lung'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0329207', 'cui_str': 'Astronotus ocellatus'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0694634', 'cui_str': 'Intra-arterial'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",348.0,0.155661,A difference of 4 months for the median PFS in favor of HAI-ox is expected (HR = 0.73).,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Pernot', 'Affiliation': 'Department of Medical Oncology, Institut Bergonié, Bordeaux, France. Electronic address: Simon.pernot@gmail.com.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Pellerin', 'Affiliation': 'Department of Interventional Radiology, Hopital Européen Georges-Pompidou, Université de Paris, SIRIC CARPEM, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mineur', 'Affiliation': 'Department of Medical Oncology, Institut Sainte Catherine, Avignon, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Monterymard', 'Affiliation': 'Federation Francophone de Cancérologie Digestive (FFCD), EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Department of Gastroenterology and GI Oncology, CHU Haut-Leveque, Université de Bordeaux, Pessac, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Lapuyade', 'Affiliation': 'Department of Interventional Radiology, CHU Haut-Leveque, Université de Bordeaux, Pessac, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Gallois', 'Affiliation': 'Department of Gastroenterology and GI Oncology, Hopital Européen Georges-Pompidou, Université de Paris, SIRIC CARPEM, France.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Khemissa Akouz', 'Affiliation': 'Department of Gastroenterology and GI Oncology, CH Saint-Jean, Perpignan, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'De Baere', 'Affiliation': 'Department of Interventional Radiology, Gustave Roussy, BIOTHERIS, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tougeron', 'Affiliation': 'Université de Poitiers, Department of Gastroenterology and Hepatology, CHU La Milétrie, Poitiers, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Thirot-Bidault', 'Affiliation': ""Department of Medical Oncology, Hôpital Privé d'Antony, Antony, France.""}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Audemar', 'Affiliation': 'Department of Gastroenterology and GI Oncology, CH de la Côte-Basque, Bayonne, France.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Simon', 'Affiliation': 'Department of Gastroenterology and GI Oncology, CH Pau, Pau, France.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Lecaille', 'Affiliation': 'Department of Gastroenterology and GI Oncology, Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Louafi', 'Affiliation': 'Department of Medical Oncology, CH Corbeille Essonne, France.'}, {'ForeName': 'Come', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': ""Federation Francophone de Cancérologie Digestive (FFCD), EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, Dijon, France; Department of Gastroenterology and GI Oncology, CHU Haut-Leveque, Université de Bordeaux, Pessac, France; Department of Interventional Radiology, CHU Haut-Leveque, Université de Bordeaux, Pessac, France; Department of Gastroenterology and GI Oncology, Hopital Européen Georges-Pompidou, Université de Paris, SIRIC CARPEM, France; Department of Gastroenterology and GI Oncology, CH Saint-Jean, Perpignan, France; Department of Interventional Radiology, Gustave Roussy, BIOTHERIS, Université Paris-Saclay, Villejuif, France; Université de Poitiers, Department of Gastroenterology and Hepatology, CHU La Milétrie, Poitiers, France; Department of Medical Oncology, Hôpital Privé d'Antony, Antony, France; Department of Gastroenterology and GI Oncology, CH de la Côte-Basque, Bayonne, France; Department of Gastroenterology and GI Oncology, CH Pau, Pau, France; Department of Gastroenterology and GI Oncology, Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France; Department of Medical Oncology, CH Corbeille Essonne, France; Department of Gastroenterology and GI oncology, CHU Le Bocage, University of Burgundy and Franche Comté, Dijon, France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ducreux', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Inserm U1279, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Department of Gastroenterology and GI Oncology, Hopital Européen Georges-Pompidou, Université de Paris, SIRIC CARPEM, France.'}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2021.12.012']
3511,34979180,Effect of immediate blood pressure reduction on post-stroke depression in ischemic stroke patients: A substudy of CATIS trial.,"BACKGROUND


Several prospective studies have identified that hypertension is an important risk factor of post-stroke depression (PSD). However, the effect of immediate antihypertensive treatment on the risk of PSD in patients with acute ischemic stroke remains unknown.
METHODS


In this prespecified depression substudy of the China Antihypertensive Trial in Acute Ischemic Stroke (CATIS) randomized clinical trial, a total of 642 patients with acute ischemic stroke within 48 h of onset and elevated systolic BP at 7 sites of CATIS were included. Patients were randomly assigned to receive antihypertensive treatment (n = 318) or to control group (n = 324). The primary outcome was depression (Hamilton Rating Scale for Depression score≥8) at 3-month posttreatment follow-up.
RESULTS


At 24 h after randomization, the mean systolic BP was reduced by 21.6 mm Hg (12.5%) in the treatment group and 13.9 mm Hg (7.9%) in the control group (difference, -7.7 mm Hg [95% CI, -10.2 to -5.2]; P<0.001). The mean systolic BP levels at 7 days (P<0.001) and 14 days (P<0.001) after randomization in treatment group were also significantly lower than those in control group. At 3-month posttreatment follow-up, 122 patients (38.4%) in antihypertensive treatment group and 131 patients (40.4%) in control group developed PSD (odds ratio, 0.92 [95% CI, 0.67 to 1.26]; P = 0.59).
LIMITATIONS


All patients in the CATIS trial were Chinese, which might limit the generalizability of our findings to other populations.
CONCLUSIONS


Early antihypertensive treatment had no effect on the risk of PSD at 3 months among patients with acute ischemic stroke and elevated BP.",2022,The mean systolic BP levels at 7 days (P<0.001) and 14 days (P<0.001) after randomization in treatment group were also significantly lower than those in control group.,"['patients with acute ischemic stroke', 'patients with acute ischemic stroke and elevated BP', 'ischemic stroke patients', '642 patients with acute ischemic stroke within 48\xa0h of onset and elevated systolic BP at 7 sites of CATIS were included']","['antihypertensive treatment', 'immediate blood pressure reduction']","['mean systolic BP levels', 'depression (Hamilton Rating Scale for Depression score≥8', 'PSD', 'mean systolic BP', 'risk of PSD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0497247', 'cui_str': 'Elevated blood pressure'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C2938940', 'cui_str': 'Post stroke depression'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",642.0,0.121667,The mean systolic BP levels at 7 days (P<0.001) and 14 days (P<0.001) after randomization in treatment group were also significantly lower than those in control group.,"[{'ForeName': 'Zhengbao', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China; Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, United States of America.'}, {'ForeName': 'Daoxia', 'Initials': 'D', 'LastName': 'Guo', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Mengyao', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, United States of America.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Bu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China; Department of Epidemiology, School of Public Health and Management, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Xuewei', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Neurology, Kerqin District First People's Hospital of Tongliao City, Inner. Mongolia, China.""}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Deqin', 'Initials': 'D', 'LastName': 'Geng', 'Affiliation': 'Department of Neurology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, United States of America; Department of Medicine, Tulane University School of Medicine, New Orleans, LA, United States of America.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, United States of America; Department of Medicine, Tulane University School of Medicine, New Orleans, LA, United States of America. Electronic address: jhe@tulane.edu.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China. Electronic address: yhzhang@suda.edu.cn.'}]",Journal of affective disorders,['10.1016/j.jad.2021.12.120']
3512,34990772,L-Citrulline supplementation attenuates aortic pulse pressure and wave reflection responses to cold stress in older adults.,"BACKGROUND AND AIMS


Augmented aortic systolic blood pressure (SBP) and wave reflection via sympathetic-mediated vasoconstriction elevates the risk for adverse cardiovascular events in older adults. L-citrulline (L-CIT) supplementation has shown to reduce aortic SBP and pulse pressure (PP) responses to cold pressor test (CPT) induced sympathoactivation in young men. The aim of this study was to elucidate the efficacy of L-CIT supplementation to attenuate aortic hemodynamic responses to CPT in older adults.
METHODS AND RESULTS


Sixteen older adults were randomly assigned to placebo or L-CIT (6 g/day) for 14-days in a crossover, double-blind, placebo-controlled design. Brachial SBP and aortic SBP, PP, augmented pressure (AP), augmentation index standardized at 75 bpm (AIx@75), and pressure of the forward (Pf) and reflected (Pb) waves were evaluated at rest and during CPT pre- and post-intervention. Although no hemodynamic changes at rest, brachial SBP (Δ-12 ± 18 vs. Δ4 ± 14 mmHg; P = 0.008) and aortic SBP (Δ-10 ± 14 vs. Δ4 ± 12 mmHg; P = 0.005), PP (Δ-10 ± 12 vs. Δ4 ± 11 mmHg; P = 0.002), AP (Δ-4 ± 4 vs. Δ2 ± 7 mmHg; P = 0.004), AIx@75 (Δ-3.2 ± 7.2 vs. Δ2.2 ± 6.9%; P = 0.038), Pf (Δ-6 ± 10 vs. Δ3 ± 9 mmHg; P = 0.019), and Pb (Δ-4 ± 6 vs. Δ2 ± 6 mmHg; P = 0.008) responses to the CPT were significantly attenuated following L-CIT supplementation vs. placebo.
CONCLUSIONS


L-CIT supplementation attenuated aortic pulsatile pressure and pressure wave reflection responses to CPT in older adults, providing possible cardioprotection during cold-induced sympathoactivation in older adults.",2022,"14 mmHg; P = 0.008) and aortic SBP (Δ-10 ± 14 vs. Δ4 ± 12 mmHg; P = 0.005), PP (Δ-10 ± 12 vs. Δ4 ± ","['Sixteen older adults', 'older adults', 'young men']","['cold pressor test (CPT', 'L-CIT supplementation', 'placebo', 'L-citrulline (L-CIT) supplementation', 'placebo or L-CIT', 'L-Citrulline supplementation']","['Brachial SBP and aortic SBP, PP, augmented pressure (AP), augmentation index standardized at 75\xa0bpm (AIx@75), and pressure of the forward (Pf) and reflected (Pb) waves', 'aortic SBP', 'aortic SBP and pulse pressure (PP) responses', 'aortic hemodynamic responses', 'aortic pulsatile pressure and pressure wave reflection responses', 'aortic systolic blood pressure (SBP']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439606', 'cui_str': 'Pulsatile'}]",16.0,0.111635,"14 mmHg; P = 0.008) and aortic SBP (Δ-10 ± 14 vs. Δ4 ± 12 mmHg; P = 0.005), PP (Δ-10 ± 12 vs. Δ4 ± ","[{'ForeName': 'Salvador J', 'Initials': 'SJ', 'LastName': 'Jaime', 'Affiliation': 'University of Wisconsin-La Crosse, 1900 Pine St, La Crosse, WI 54601, USA. Electronic address: sjaime@uwlax.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Nagel', 'Affiliation': 'University of Wisconsin-La Crosse, 1900 Pine St, La Crosse, WI 54601, USA.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Maharaj', 'Affiliation': 'Texas Tech University, 2500 Broadway, Lubbock, TX 79409, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Fischer', 'Affiliation': 'Texas Tech University, 2500 Broadway, Lubbock, TX 79409, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schwab', 'Affiliation': 'University of Wisconsin-La Crosse, 1900 Pine St, La Crosse, WI 54601, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Martinson', 'Affiliation': 'University of Wisconsin-La Crosse, 1900 Pine St, La Crosse, WI 54601, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Radtke', 'Affiliation': 'University of Wisconsin-La Crosse, 1900 Pine St, La Crosse, WI 54601, USA.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Mikat', 'Affiliation': 'University of Wisconsin-La Crosse, 1900 Pine St, La Crosse, WI 54601, USA.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Figueroa', 'Affiliation': 'Texas Tech University, 2500 Broadway, Lubbock, TX 79409, USA.'}]",Experimental gerontology,['10.1016/j.exger.2021.111685']
3513,35041261,Effects of eszopiclone on sleep quality and cognitive function in elderly patients with Alzheimer's disease and sleep disorder: A randomized controlled trial.,"OBJECTIVE


To investigate the effects of eszopiclone on sleep quality and cognitive function in elderly patients with Alzheimer's disease (AD) and sleep disorders.
METHODS


This study was a prospective study of 96 elderly patients with AD and sleep disturbance treated in our hospital from April 2019 to December 2020. All patients were divided into a control group (48 patients, given alprazolam tablets) and a study group (48 patients, given eszopiclone) according to the random number table method.
RESULTS


After treatment, compared with the control group, the study group had lower sleep latency, daytime function, sleep disturbance, sleep efficiency, sleep quality, sleeping time, and hypnotic medication scores (p < .05). After treatment, sleep progression and sleep architecture improvement were more obvious in the study group compared with the control group (p < .05). After treatment, compared with the control group, the rhythm disturbance, psychotic disorder, hallucination, phobic anxiety, and disorder in the study group improved more significantly (p < .05). After treatment, compared with the control group, the scores of orientation, attention, memory, calculation, recall, and language ability in the study group improved more significantly (p < .05). After treatment, the scores of the physical life self-care scale and instrumental activities of daily living scale in the study group were improved more obviously compared with the control group, with significant differences (p < .05).
CONCLUSION


Eszopiclone can effectively improve the quality of sleep and cognitive function in elderly patients with AD and sleep disorder.",2022,"After treatment, the scores of the physical life self-care scale and instrumental activities of daily living scale in the study group were improved more obviously compared with the control group, with significant differences (p < .05).
","['96 elderly patients with AD and sleep disturbance treated in our hospital from April 2019 to December 2020', 'elderly patients with AD and sleep disorder', ""elderly patients with Alzheimer's disease and sleep disorder"", ""elderly patients with Alzheimer's disease (AD) and sleep disorders""]","['Eszopiclone', 'alprazolam tablets', 'eszopiclone']","['lower sleep latency, daytime function, sleep disturbance, sleep efficiency, sleep quality, sleeping time, and hypnotic medication scores', 'sleep progression and sleep architecture improvement', 'scores of orientation, attention, memory, calculation, recall, and language ability', 'sleep quality and cognitive function', 'quality of sleep and cognitive function', 'scores of the physical life self-care scale and instrumental activities of daily living scale', 'rhythm disturbance, psychotic disorder, hallucination, phobic anxiety, and disorder']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}]","[{'cui': 'C1436328', 'cui_str': 'Eszopiclone'}, {'cui': 'C1244569', 'cui_str': 'Alprazolam Oral Tablet'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",96.0,0.0552108,"After treatment, the scores of the physical life self-care scale and instrumental activities of daily living scale in the study group were improved more obviously compared with the control group, with significant differences (p < .05).
","[{'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Huo', 'Affiliation': 'Department of Hospital Infection Management, The Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University, Wuhan, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Outpatient Department, The Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University, Wuhan, China.'}, {'ForeName': 'Shuying', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'General Department, The Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University, Wuhan, China.'}, {'ForeName': 'Fulu', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Internal Medicine, The Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University, Wuhan, China.'}]",Brain and behavior,['10.1002/brb3.2488']
3514,35043140,"HbA1c Reduction in Dulaglutide-Treated Patients Irrespective of Duration of Diabetes, Microvascular Disease, and BMI: A Post Hoc Analysis From the REWIND Trial.","OBJECTIVE


To evaluate participant characteristics and long-term changes in glycated hemoglobin (HbA1c) levels in patients treated with dulaglutide 1.5 mg in a post hoc analysis of the Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial.
RESEARCH DESIGN AND METHODS


Change from baseline in HbA1c was assessed during and up to 72 months of treatment before and after adjustment for duration of diabetes, prior microvascular disease (nephropathy or retinopathy), and BMI. Slope analyses were used to assess the change in HbA1c during 0-12 months and 12-72 months of therapy.
RESULTS


HbA1c was significantly reduced in patients treated with dulaglutide compared with placebo during 72 months of treatment (least-squares mean difference = -0.61%, P < 0.001), regardless of diabetes duration, prior microvascular disease, and BMI (all interaction P > 0.07). Significant reductions were apparent at all time points and were independent of these baseline characteristics. Slope analyses revealed that the dulaglutide group experienced a higher rate of HbA1c reduction compared with the placebo group from 0 to 12 months before and after adjustment. The dulaglutide group also experienced a higher rate of HbA1c increase from 12 to 72 months compared with the placebo group that became nonsignificant after adjustment for diabetes duration, prior microvascular disease, and BMI combined. Despite the greater rate of HbA1c increase in the dulaglutide group during this period, mean HbA1c values remained below baseline in the dulaglutide group and below mean HbA1c values in the placebo group.
CONCLUSIONS


Dulaglutide 1.5-mg treatment was statistically associated with a long-lasting decrease in HbA1c over 72 months, irrespective of baseline duration of diabetes, microvascular disease, and BMI.",2022,Slope analyses revealed that the dulaglutide group experienced a higher rate of HbA1c reduction compared with the placebo group from 0 to 12 months before and after adjustment.,"['Dulaglutide-Treated Patients', 'patients treated with dulaglutide 1.5 mg in a post hoc analysis of the Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial', 'Change from baseline in HbA1c was assessed during and up to 72 months of treatment before and after adjustment for duration of diabetes, prior microvascular disease (nephropathy or retinopathy), and BMI']",['placebo'],"['mean HbA1c values', 'glycated hemoglobin (HbA1c) levels', 'HbA1c', 'regardless of diabetes duration, prior microvascular disease, and BMI', 'baseline duration of diabetes, microvascular disease, and BMI', 'HbA1c Reduction', 'rate of HbA1c reduction', 'rate of HbA1c increase']","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1562292', 'cui_str': 'Incretin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0239940', 'cui_str': 'Glycosylated haemoglobin increased'}]",,0.150316,Slope analyses revealed that the dulaglutide group experienced a higher rate of HbA1c reduction compared with the placebo group from 0 to 12 months before and after adjustment.,"[{'ForeName': 'Anita Y M', 'Initials': 'AYM', 'LastName': 'Kwan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Basile', 'Affiliation': 'Medical University of South Carolina, Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': 'St. Johns Medical College and Research Institute, Bangalore, India.'}, {'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'Maldonado', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN.'}, {'ForeName': 'Sohini', 'Initials': 'S', 'LastName': 'Raha', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN.'}, {'ForeName': 'Manige', 'Initials': 'M', 'LastName': 'Konig', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN.'}]",Diabetes care,['10.2337/dc21-1160']
3515,35019976,Association Between Change in Accelerometer-Measured and Self-Reported Physical Activity and Cardiovascular Disease in the Look AHEAD Trial.,"OBJECTIVE


To conduct post hoc secondary analysis examining the association between change in physical activity. Measured with self-report and accelerometry, from baseline to 1 and 4 years and cardiovascular disease (CVD) outcomes in the Look AHEAD Trial.
RESEARCH DESIGN AND METHODS


Participants were adults with overweight/obesity and type 2 diabetes with physical activity. Data at baseline and year 1 or 4 (n = 1,978). Participants were randomized to diabetes support and education or intensive lifestyle intervention. Measures included accelerometry-measured moderate-to-vigorous physical activity (MVPA), self-reported physical activity, and composite (morbidity and mortality) CVD outcomes.
RESULTS


In pooled analyses of all participants, using Cox proportional hazards models, each 100 MET-min/week increase in accelerometry-measured MVPA from baseline to 4 years was associated with decreased risk of the subsequent primary composite outcome of CVD. Results were consistent for changes in total MVPA (hazard ratio 0.97 [95% CI 0.95, 0.99]) and MVPA accumulated in ≥10-min bouts (hazard ratio 0.95 [95% CI 0.91, 0.98]), with a similar pattern for secondary CVD outcomes. Change in accelerometry-measured MVPA at 1 year and self-reported change in physical activity at 1 and 4 years were not associated with CVD outcomes.
CONCLUSIONS


Increased accelerometry-measured MVPA from baseline to year 4 is associated with decreased risk of CVD outcomes. This suggests the need for long-term engagement in MVPA to reduce the risk of CVD in adults with overweight/obesity and type 2 diabetes.",2022,"Results were consistent for changes in total MVPA (hazard ratio 0.97 [95% CI 0.95, 0.99]) and MVPA accumulated in ≥10-min bouts (hazard ratio 0.95 [95% CI 0.91, 0.98]), with a similar pattern for secondary CVD outcomes.","['Participants were adults with overweight/obesity and type 2 diabetes with Physical activity', 'adults with overweight/obesity and type 2 diabetes']",['diabetes support and education or intensive lifestyle intervention'],"['accelerometry-measured moderate-to-vigorous physical activity', 'total MVPA', 'MVPA), self-reported physical activity., and composite (morbidity and mortality', 'cardiovascular disease (CVD) outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.427245,"Results were consistent for changes in total MVPA (hazard ratio 0.97 [95% CI 0.95, 0.99]) and MVPA accumulated in ≥10-min bouts (hazard ratio 0.95 [95% CI 0.91, 0.98]), with a similar pattern for secondary CVD outcomes.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': ''}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': ''}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Bolin', 'Affiliation': ''}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': ''}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': ''}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Egan', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': ''}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Foreyt', 'Affiliation': ''}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Fulton', 'Affiliation': ''}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': ''}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Gregg', 'Affiliation': ''}, {'ForeName': 'Helen P', 'Initials': 'HP', 'LastName': 'Hazuda', 'Affiliation': ''}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': ''}, {'ForeName': 'Van S', 'Initials': 'VS', 'LastName': 'Hubbard', 'Affiliation': ''}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Jeffery', 'Affiliation': ''}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kure', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lang', 'Affiliation': ''}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Nathan', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Patricio', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': ''}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Pownall', 'Affiliation': ''}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': ''}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Safford', 'Affiliation': ''}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': ''}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Walkup', 'Affiliation': ''}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': ''}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wyatt', 'Affiliation': ''}]",Diabetes care,['10.2337/dc21-1206']
3516,34855513,Impact of community masking on COVID-19: A cluster-randomized trial in Bangladesh.,"We conducted a cluster-randomized trial to measure the effect of community-level mask distribution and promotion on symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in rural Bangladesh from November 2020 to April 2021 ( N  = 600 villages,  N  = 342,183 adults). We cross-randomized mask type (cloth versus surgical) and promotion strategies at the village and household level. Proper mask-wearing increased from 13.3% in the control group to 42.3% in the intervention arm (adjusted percentage point difference = 0.29; 95% confidence interval = [0.26, 0.31]). The intervention reduced symptomatic seroprevalence (adjusted prevalence ratio = 0.91 [0.82, 1.00]), especially among adults ≥60 years old in villages where surgical masks were distributed (adjusted prevalence ratio = 0.65 [0.45, 0.85]). Mask distribution with promotion was a scalable and effective method to reduce symptomatic SARS-CoV-2 infections.",2022,[Figure: see text].,[],['community masking on COVID-19'],[],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",[],,0.104814,[Figure: see text].,"[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Abaluck', 'Affiliation': 'Yale School of Management, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Kwong', 'Affiliation': 'Woods Institute for the Environment, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Styczynski', 'Affiliation': 'Division of Infectious Diseases and Geographic Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ashraful', 'Initials': 'A', 'LastName': 'Haque', 'Affiliation': 'Innovations for Poverty Action Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Md Alamgir', 'Initials': 'MA', 'LastName': 'Kabir', 'Affiliation': 'Innovations for Poverty Action Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Bates-Jefferys', 'Affiliation': 'Innovations for Poverty Action, Evanston, IL, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Crawford', 'Affiliation': 'Yale School of Management, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Benjamin-Chung', 'Affiliation': 'Department of Epidemiology and Population Health, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Shabib', 'Initials': 'S', 'LastName': 'Raihan', 'Affiliation': 'Innovations for Poverty Action Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Shadman', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Innovations for Poverty Action Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Benhachmi', 'Affiliation': 'Yale Research Initiative on Innovation and Scale, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Neeti Zaman', 'Initials': 'NZ', 'LastName': 'Bintee', 'Affiliation': 'Innovations for Poverty Action Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Winch', 'Affiliation': 'Social and Behavioral Interventions Program, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Maqsud', 'Initials': 'M', 'LastName': 'Hossain', 'Affiliation': 'NGRI, North South University, Dhaka, Bangladesh.'}, {'ForeName': 'Hasan Mahmud', 'Initials': 'HM', 'LastName': 'Reza', 'Affiliation': 'Department of Pharmaceutical Sciences, North South University, Dhaka, Bangladesh.'}, {'ForeName': 'Abdullah All', 'Initials': 'AA', 'LastName': 'Jaber', 'Affiliation': 'NGRI, North South University, Dhaka, Bangladesh.'}, {'ForeName': 'Shawkee Gulshan', 'Initials': 'SG', 'LastName': 'Momen', 'Affiliation': 'NGRI, North South University, Dhaka, Bangladesh.'}, {'ForeName': 'Aura', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'NGRI, North South University, Dhaka, Bangladesh.'}, {'ForeName': 'Faika Laz', 'Initials': 'FL', 'LastName': 'Banti', 'Affiliation': 'NGRI, North South University, Dhaka, Bangladesh.'}, {'ForeName': 'Tahrima Saiha', 'Initials': 'TS', 'LastName': 'Huq', 'Affiliation': 'NGRI, North South University, Dhaka, Bangladesh.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Woods Institute for the Environment, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ahmed Mushfiq', 'Initials': 'AM', 'LastName': 'Mobarak', 'Affiliation': 'Yale School of Management, Yale University, New Haven, CT, USA.'}]","Science (New York, N.Y.)",['10.1126/science.abi9069']
3517,35026217,Anodal tDCS over Broca's area improves fast mapping and explicit encoding of novel vocabulary.,"An accumulating body of evidence suggests that transcranial direct current stimulation (tDCS) can be used to affect language processing, including word acquisition. There has been, however, no comprehensive study of effects of tDCS of the core language areas in relation to the main word-learning mechanisms. Two principal strategies have been posited as important for natural word acquisition: explicit encoding (EE) which relies on direct instructions and repetition of material, and fast mapping (FM) which operates implicitly, via context-based inference or deduction. We used anodal and cathodal tDCS of Broca's and Wernicke's areas to assess effects of stimulation site and polarity on novel word acquisition in both EE and FM regimes. 160 participants, divided into five groups, received 15 min of cathodal or anodal tDCS over one of the two areas or a sham (placebo) stimulation before learning eight novel words, presented ten times each in a short naturalistic audio-visual word-picture association session, fully counterbalanced across different learning regimes. The outcome of novel word acquisition was measured immediately after the training using a free recall task. The results showed elevated accuracy in all real stimulation groups in comparison with sham stimulation; however, this effect only reached full significance after anodal tDCS of Broca's area. Comparisons between the two learning modes indicated that Broca's anodal tDCS significantly improved both implicit and explicit acquisition of novel vocabulary in comparison with sham tDCS, without, however, any significant differences between EE and FM regimes as such. The results indicate involvement of the left inferior-frontal neocortex in the learning of novel vocabulary and suggest a possibility to promote different types of word acquisition using anodal tDCS of this area.",2022,"Comparisons between the two learning modes indicated that Broca's anodal tDCS significantly improved both implicit and explicit acquisition of novel vocabulary in comparison with sham tDCS, without, however, any significant differences between EE and FM regimes as such.","['160 participants', 'healthy individuals and in patients with speech disorders']","['15\u202fmin of cathodal or anodal tDCS over one of the two areas or a sham (placebo) stimulation before learning eight novel words, presented ten times each in a short naturalistic audio-visual word-picture association session, fully counterbalanced across different learning regimes', 'Anodal tDCS', 'transcranial direct current stimulation (tDCS']","['Behavioural outcome of novel word acquisition', 'implicit and explicit acquisition of novel vocabulary', 'fast mapping and explicit encoding of novel vocabulary']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037822', 'cui_str': 'Speech disorder'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}]",160.0,0.038181,"Comparisons between the two learning modes indicated that Broca's anodal tDCS significantly improved both implicit and explicit acquisition of novel vocabulary in comparison with sham tDCS, without, however, any significant differences between EE and FM regimes as such.","[{'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Perikova', 'Affiliation': 'Laboratory of Behavioural Neurodynamics, Saint Petersburg State University, Saint Petersburg, Russia. Electronic address: e.perikova@spbu.ru.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Blagovechtchenski', 'Affiliation': 'Laboratory of Behavioural Neurodynamics, Saint Petersburg State University, Saint Petersburg, Russia.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Filippova', 'Affiliation': 'Laboratory of Behavioural Neurodynamics, Saint Petersburg State University, Saint Petersburg, Russia; Department of General Psychology, Faculty of Psychology, Saint Petersburg State University, Saint Petersburg, Russia.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Shcherbakova', 'Affiliation': 'Laboratory of Behavioural Neurodynamics, Saint Petersburg State University, Saint Petersburg, Russia; Department of General Psychology, Faculty of Psychology, Saint Petersburg State University, Saint Petersburg, Russia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kirsanov', 'Affiliation': 'Laboratory of Behavioural Neurodynamics, Saint Petersburg State University, Saint Petersburg, Russia.'}, {'ForeName': 'Yury', 'Initials': 'Y', 'LastName': 'Shtyrov', 'Affiliation': 'Center of Functionally Integrative Neuroscience (CFIN), Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: yury@cfin.au.dk.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2022.108156']
3518,35031521,Daily meditation program for anxiety in individuals admitted to the antepartum unit: a multicenter randomized controlled trial (MEDITATE).,"BACKGROUND


Inpatient antepartum women have higher levels of anxiety than outpatient. Former randomized trials using mindful meditation programs to decrease maternal anxiety have conflicting results; some studies showed a considerable decrease in anxiety levels, whereas others showed no difference. A paucity of trials exist using mindful meditation for maternal anxiety in the inpatient antepartum population; most studies focus on the outpatient clinic population. Because of inpatient acuity and anxiety factors, we conducted a randomized trial to target this population.
OBJECTIVE


This study aimed to compare anxiety levels on day 4 of either routine care or routine care plus a twice-daily application-based mindful meditation program in women admitted to the antepartum unit.
STUDY DESIGN


In a multisite randomized trial (ClinicalTrials.gov Identifier: NCT03737279), women admitted to the antepartum units were randomized to either routine care plus educational pamphlets (control arm) or routine care plus a twice-daily application-based mindful meditation program (intervention arm). The inclusion criteria were age of at least 18 years, gestational age of at least 23 weeks, planned inpatient care for >3 days from randomization, and care by our university physician team. The primary outcome was maternal state anxiety level (measured using the validated State-Trait Anxiety Inventory) on day 4 (randomization being day 1). The secondary outcomes included stress (measured using the Perceived Stress Scale) and depression (measured using the Edinburgh Depression Scale) on day 4, latency period from randomization to delivery, patient experience, number of meditation sessions, and total meditation time. A total of 56 women were needed for 90% power to detect a decrease in the primary outcome by 30% in the intervention group, compared with the control group. All women were observed using an intention-to-treat analysis. We compared the continuous variables using the Wilcoxon rank-sum test or t test and the categorical variables using the chi-squared test or the Fisher exact test.
RESULTS


From March 4, 2019, to December 20, 2019, 412 women were screened for eligibility, 77 women (18.7%) were found eligible, and 56 women (72.7%) were randomized with 28 women in each group. Of note, 96.4% of women completed at least 1 meditation session, and 39.3% of women completed all meditation sessions. The mean score of the anxiety level using the State-Trait Anxiety Inventory on day 4 was not significantly different (P=.24) between the control group (42.0±10.8) and meditation group (37.5±13.1). A decreased anxiety score from day 1 to day 4 was seen in both the control group and meditation group (-4.7 vs -9.4, respectively; P=.12). The rate of abnormal State-Trait Anxiety Inventory scores on day 4 was not significantly different between the control group and meditation group (62% vs 45%, respectively; P=.28). When asked about the experience with the research trial, 88.8% of women in the control group and 89.5% of women in the meditation group reported a positive experience.
CONCLUSION


Compared with the control group, a twice-daily application-based mindful meditation program for women admitted to the antepartum unit did not considerably decrease the anxiety score on day 4. However, >88% of women in both groups had a positive experience with the nonpharmacologic intervention.",2022,"A decreased anxiety score from day 1 to day 4 was seen in both the control group (- 4.7) and the meditation group (- 9.4, p=0.12).","['individuals admitted to the antepartum unit', 'Admitted to the Antepartum Unit', 'Inclusion criteria were age of at least 18 years, gestational age of at least 23 weeks, planned inpatient care for more than 3 days from randomization, and care by our university physician team', 'individuals admitted to the antepartum units', 'From March 4, 2019 through December 20, 2019, 412 women were screened for eligibility, 77 (18.7%) found eligible, and 56 (72.7%) randomized with 28 in each group', '56 women', 'Individuals']","['Daily Meditation Program', 'twice-daily application-based mindful meditation program', 'routine care or routine care plus an application-based twice-daily mindful meditation program', 'mindful meditation', 'routine care plus educational pamphlets (control arm) or routine care plus a twice-daily application-based mindful meditation program (intervention arm', 'mindful meditation programs']","['rate of abnormal STAI scores', 'maternal state anxiety level (measured by the validated State Trait Anxiety Inventory, STAI', 'mean score of STAI anxiety level', 'anxiety levels', 'maternal anxiety', 'positive experience', 'anxiety score', 'stress (measured by Perceived Stress Scale, PSS) and depression (measured by Edinburgh Depression Scale, EDS) on day 4, latency period from randomization to delivery, patient experience, number of meditation sessions, and total meditation time']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0456336', 'cui_str': 'Antepartum'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023103', 'cui_str': 'Latency Period (Psychology)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",56.0,0.0620585,"A decreased anxiety score from day 1 to day 4 was seen in both the control group (- 4.7) and the meditation group (- 9.4, p=0.12).","[{'ForeName': 'Morgen S', 'Initials': 'MS', 'LastName': 'Doty', 'Affiliation': 'Obstetrix Maternal-Fetal Medicine Specialists of Houston, Houston, TX (Dr Doty). Electronic address: msdoty@gmail.com.'}, {'ForeName': 'Han-Yang', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX (Dr Chen, Ms Ajishegiri, and Drs Sibai, Blackwell, and Chauhan).'}, {'ForeName': 'Oluwadare', 'Initials': 'O', 'LastName': 'Ajishegiri', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX (Dr Chen, Ms Ajishegiri, and Drs Sibai, Blackwell, and Chauhan).'}, {'ForeName': 'Baha M', 'Initials': 'BM', 'LastName': 'Sibai', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX (Dr Chen, Ms Ajishegiri, and Drs Sibai, Blackwell, and Chauhan).'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX (Dr Chen, Ms Ajishegiri, and Drs Sibai, Blackwell, and Chauhan).'}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX (Dr Chen, Ms Ajishegiri, and Drs Sibai, Blackwell, and Chauhan).'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100562']
3519,34856530,Perioperative supplemental oxygen and oxidative stress in patients undergoing moderate- to high-risk major abdominal surgery - A subanalysis of randomized clinical trial.,"STUDY OBJECTIVE


Oxidative stress plays a pivotal role in the development and aggravation of cardiovascular diseases. The influence of intraoperative inspired oxygen concentrations on oxidative stress is still not entirely known. Therefore, we evaluated in this sub-study if supplemental oxygen affects the oxidation-reduction potential in patients at-risk for cardiovascular complications undergoing moderate- to high-risk major abdominal surgery.
DESIGN


Sub-study of a prospective parallel-arm double-blinded single-center superiority randomized trial.
SETTING


Operating room and postoperative recovery area.
INTERVENTION


Administration of 0.8 FiO 2  versus 0.3 FiO 2  throughout surgery and for the first two postoperative hours.
MEASUREMENTS


The primary outcome was the static oxidation-reduction potential (sORP) and the oxidation-reduction potential capacity (cORP) between both groups. The secondary outcome was the trend of sORP and cORP in the overall study population. We assessed sORP and cORP before induction of anesthesia, 2 h after induction of anesthesia, within 2 h after surgery and on the first and third postoperative day.
MAIN RESULTS


258 patients were analyzed. 128 patients were randomly assigned to the 80% oxygen group and 130 patients were randomly assigned to the 30% oxygen group. Postoperative sORP values did not differ significantly between the 80% and 30% oxygen group (effect estimate: -1.162 mV,95% CI: -2.584 to 0.260; p = 0.109). On average, we observed a change in sORP of 5.288 mV (95% CI:4.633 to 5.913, p < 0.001) per day. cORP values did not differ significantly between the 80% and 30% oxygen group (effect estimate: -0.015μC, (95%CI: -0.062 to 0.032; p = 0.524). On average, we observed a change in cORP values of -0.170μC (95%CI: -0.194 to -0.147, p < 0.001) per day.
CONCLUSION


In contrast to previous reports, we could not find any evidence of an association between intraoperative supplemental oxygen and perioperative oxidative stress assessed by sORP and cORP.
TRIAL REGISTRATION


clinicaltrials.gov: NCT03366857https://clinicaltrials.gov/ct2/show/NCT03366857?term=vienna&cond=oxygen&draw=2&rank=1.",2022,"cORP values did not differ significantly between the 80% and 30% oxygen group (effect estimate: -0.015μC,","['258 patients were analyzed', 'patients undergoing moderate- to high-risk major abdominal surgery ', 'patients at-risk for cardiovascular complications undergoing moderate- to high-risk major abdominal surgery', '128 patients were randomly assigned to the 80% oxygen group and 130 patients']","['intraoperative inspired oxygen concentrations', 'Perioperative supplemental oxygen and oxidative stress', 'NCT03366857https://clinicaltrials.gov', 'ct2/show']","['Postoperative sORP values', 'cORP values', 'static oxidation-reduction potential (sORP) and the oxidation-reduction potential capacity (cORP', 'sORP and cORP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0161816', 'cui_str': 'Cardiac complication'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0428648', 'cui_str': 'Inspired oxygen concentration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",258.0,0.82722,"cORP values did not differ significantly between the 80% and 30% oxygen group (effect estimate: -0.015μC,","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Reiterer', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria; Outcomes Research Consortium, Cleveland, OH, USA.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria; Outcomes Research Consortium, Cleveland, OH, USA. Electronic address: edith.fleischmann@meduniwien.ac.at.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Taschner', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'Adamowitsch', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Markus Falkner', 'Initials': 'MF', 'LastName': 'von Sonnenburg', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Graf', 'Affiliation': 'Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Fraunschiel', 'Affiliation': 'IT Systems and Communications, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Starlinger', 'Affiliation': 'Department of Surgery, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Goschin', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kabon', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, 1090 Vienna, Austria; Outcomes Research Consortium, Cleveland, OH, USA.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110614']
3520,34921960,"The ECHELON-2 Trial: 5-year results of a randomized, phase III study of brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma.","BACKGROUND


For patients with peripheral T-cell lymphoma (PTCL), outcomes using frontline treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or CHOP-like therapy are typically poor. The ECHELON-2 study demonstrated that brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (A+CHP) exhibited statistically superior progression-free survival (PFS) per independent central review and improvements in overall survival versus CHOP for the frontline treatment of patients with systemic anaplastic large cell lymphoma or other CD30-positive PTCL.
PATIENTS AND METHODS


ECHELON-2 is a double-blind, double-dummy, randomized, placebo-controlled, active-comparator phase III study. We present an exploratory update of the ECHELON-2 study, including an analysis of 5-year PFS per investigator in the intent-to-treat analysis group.
RESULTS


A total of 452 patients were randomized (1 : 1) to six or eight cycles of A+CHP (N = 226) or CHOP (N = 226). At median follow-up of 47.6 months, 5-year PFS rates were 51.4% [95% confidence interval (CI): 42.8% to 59.4%] with A+CHP versus 43.0% (95% CI: 35.8% to 50.0%) with CHOP (hazard ratio = 0.70; 95% CI: 0.53-0.91), and 5-year overall survival (OS) rates were 70.1% (95% CI: 63.3% to 75.9%) with A+CHP versus 61.0% (95% CI: 54.0% to 67.3%) with CHOP (hazard ratio = 0.72; 95% CI: 0.53-0.99). Both PFS and OS were generally consistent across key subgroups. Peripheral neuropathy was resolved or improved in 72% (84/117) of patients in the A+CHP arm and 78% (97/124) in the CHOP arm. Among patients who relapsed and subsequently received brentuximab vedotin, the objective response rate was 59% with brentuximab vedotin retreatment after A+CHP and 50% with subsequent brentuximab vedotin after CHOP.
CONCLUSIONS


In this 5-year update of ECHELON-2, frontline treatment of patients with PTCL with A+CHP continues to provide clinically meaningful improvement in PFS and OS versus CHOP, with a manageable safety profile, including continued resolution or improvement of peripheral neuropathy.",2022,Peripheral neuropathy was resolved or improved in 72% (84/117) of patients in the A+CHP arm and 78% (97/124) in the CHOP arm.,"['for CD30-positive peripheral T-cell lymphoma', '452 patients', 'patients with systemic anaplastic large cell lymphoma or other CD30-positive PTCL', 'patients with PTCL with', 'patients with peripheral T-cell lymphoma (PTCL']","['placebo', 'brentuximab vedotin with chemotherapy', 'brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (A+CHP', 'cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or CHOP-like therapy', 'A+CHP']","['objective response rate', 'overall survival versus CHOP', 'Peripheral neuropathy', '5-year overall survival (OS) rates', 'superior progression-free survival (PFS', '5-year PFS rates']","[{'cui': 'C3888910', 'cui_str': 'CD30 positive'}, {'cui': 'C0079774', 'cui_str': 'Peripheral T-cell lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206180', 'cui_str': 'Large cell anaplastic lymphoma'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",452.0,0.33853,Peripheral neuropathy was resolved or improved in 72% (84/117) of patients in the A+CHP arm and 78% (97/124) in the CHOP arm.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Horwitz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, USA. Electronic address: horwitzs@mskcc.org.'}, {'ForeName': 'O A', 'Initials': 'OA', 'LastName': ""O'Connor"", 'Affiliation': 'University of Virginia Cancer Center, University of Virginia, Charlottesville, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Pro', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Trümper', 'Affiliation': 'Universitätsmedizin Göttingen, Göttingen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Iyer', 'Affiliation': 'MD Anderson Cancer Center/University of Texas, Houston, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Advani', 'Affiliation': 'Stanford Cancer Center, Blood and Marrow Transplant Program, Stanford, USA.'}, {'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Washington University School of Medicine, St. Louis, USA.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Christensen', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Morschhauser', 'Affiliation': 'CHRU de Lille, Lille cedex, Nord-Pas-de-Calais, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Domingo-Domenech', 'Affiliation': ""Institut Catala D'oncologia, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rossi', 'Affiliation': 'Azienda Ospedaliera Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'W S', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Feldman', 'Affiliation': 'John Theurer Cancer Center, Hackensack Meridian Health School of Medicine, Hackensack, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Menne', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Fourth Department of Internal Medicine - Haematology, Charles University Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.'}, {'ForeName': 'Á', 'Initials': 'Á', 'LastName': 'Illés', 'Affiliation': 'Debreceni Egyetem, Debrecen, Hajdu-Bihar, Hungary.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tobinai', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tsukasaki', 'Affiliation': 'Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'S-P', 'Initials': 'SP', 'LastName': 'Yeh', 'Affiliation': 'China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shustov', 'Affiliation': 'University of Washington Medical Center, Seattle, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hüttmann', 'Affiliation': 'Universitatsklinikum Essen, Essen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Savage', 'Affiliation': 'Department of Medical Oncology and University of British Columbia, BC Cancer, Vancouver, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yuen', 'Affiliation': 'Calvary Mater Newcastle Hospital, Waratah, Australia.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': ""IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia 'Seràgnoli', Bologna, Italy; Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna, Bologna, Italy.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'Millennium Pharmaceuticals, Inc, Cambridge, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bunn', 'Affiliation': 'Millennium Pharmaceuticals, Inc, Cambridge, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fenton', 'Affiliation': 'Seagen Inc., Bothell, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fanale', 'Affiliation': 'Seagen Inc., Bothell, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Puhlmann', 'Affiliation': 'Seagen Inc., Bothell, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Illidge', 'Affiliation': 'Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, NIHR Biomedical Research Centre, Manchester Academic Health Sciences Centre, Christie Hospital NHS Foundation Trust, Manchester, UK.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.12.002']
3521,35007840,Transcutaneous auricular vagus nerve stimulation cannot modulate the P3b event-related potential in healthy volunteers.,"OBJECTIVE


The release of cortical norepinephrine is one of the possible mechanisms of action of vagus nerve stimulation (VNS), a neuromodulatory treatment currently under investigation for cognitive impairment. Transcutaneous auricular VNS (taVNS) may be able to activate vagal nerve branches ending in the brainstem's locus coeruleus (LC) non-invasively. The aim was to investigate if acute taVNS can modulate the P3b, a cognitive event-related potential (ERP) reflecting noradrenergic brain activation under control of the LC.
METHODS


Thirty-nine healthy volunteers performed an auditory oddball task during no stimulation, sham stimulation and taVNS in a randomized order. P3b amplitude, latency and behavioral outcome parameters were compared between conditions using linear mixed models.
RESULTS


P3b amplitude and latency during taVNS did not differ significantly from sham or control. Reaction time shortened and P3b latency prolonged with repetition of the oddball task.
CONCLUSIONS


We were unable to modulate cognitive ERPs by means of acute taVNS in a large group of healthy volunteers.
SIGNIFICANCE


Targeting vagal nerve fibres via a transcutaneous approach did not alter the P3b in healthy participants. The stimulation parameters used and transient delivery of taVNS might be insufficient to adequately modulate the LC. Also, a disbalanced locus coeruleus - norepinephrine system in patients may be more prone for improvement.",2022,P3b amplitude and latency during taVNS did not differ significantly from sham or control.,"['healthy participants', 'Thirty-nine healthy volunteers', 'healthy volunteers']","['auditory oddball task during no stimulation, sham stimulation and taVNS', 'Transcutaneous auricular vagus nerve stimulation', 'Transcutaneous auricular VNS (taVNS']","['P3b amplitude, latency and behavioral outcome parameters', 'Reaction time shortened and P3b latency prolonged with repetition of the oddball task', 'P3b amplitude and latency during taVNS']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816447', 'cui_str': '39'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0445093', 'cui_str': 'No stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}]",39.0,0.0359423,P3b amplitude and latency during taVNS did not differ significantly from sham or control.,"[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Gadeyne', 'Affiliation': '4Brain, Department of Neurology, Ghent University Hospital, Ghent, Belgium. Electronic address: Stefanie.Gadeyne@uzgent.be.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Mertens', 'Affiliation': '4Brain, Department of Neurology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Carrette', 'Affiliation': '4Brain, Department of Neurology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Freek', 'Initials': 'F', 'LastName': 'Van den Bossche', 'Affiliation': '4Brain, Department of Neurology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Boon', 'Affiliation': '4Brain, Department of Neurology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Robrecht', 'Initials': 'R', 'LastName': 'Raedt', 'Affiliation': '4Brain, Department of Neurology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Kristl', 'Initials': 'K', 'LastName': 'Vonck', 'Affiliation': '4Brain, Department of Neurology, Ghent University Hospital, Ghent, Belgium.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2021.11.079']
3522,35018724,The granulation tissue preservation technique in regenerative periodontal surgery-a randomized controlled clinical trial.,"OBJECTIVES


To investigate if the application of the granulation tissue preservation technique (GTPT) in regenerative therapy of infrabony periodontal defects results in more clinical attachment level (CAL) gain and more radiographic bone gain (RBG) than the conventional resective approach 12 months after surgery.
MATERIALS AND METHODS


Forty patients exhibiting at least one infrabony defect with a probing pocket depth (PPD) ≥6 mm and a radiographic infrabony component (INFRA X-ray  ) ≥3 mm were randomly treated with the GTPT (test group) or the double-flap approach with resection of the defect-filling granulation tissue (control group). Enamel matrix derivatives were applied in both groups. Clinical and radiographic parameters were recorded at baseline (t0), 6 months (t1), and 12 months (t2) after surgery. The primary outcome variable was CAL gain between t0 and t2.
RESULTS


When all patients were considered, ΔCAL t0-t2  did not differ significantly between the two groups (p = .160). Significant PPD reduction (test group: 4.38 ± 1.36 mm; control group: 4.06 ± 2.38 mm), CAL gain (test group: 3.75 ± 1.24 mm; control group: 2.88 ± 2.09 mm), and RBG (test group: 3.06 ± 1.74 mm; control group: 3.27 ± 2.19 mm) were achieved at t2 in both groups. Using multivariate linear regression, PPD t0  and group were identified as variables with the greatest influence on ΔCAL t0-t2  . PPD t0  and INFRA X-ray  were identified as variables with the greatest influence on RBG t0-t2  . Patients with a defect angle >22° showed significantly more CAL gain in the test group (t0-t1: 3.08 ± 1.38 mm; t0-t2: 3.62 ± 0.96 mm) than in the control group (t0-t1: 1.77 ± 1.54 mm; t0-t2: 2.18 ± 1.83 mm).
CONCLUSIONS


Regarding all patients, the study failed to show significant differences between the test and control groups. However, the GTPT appears to lead to more CAL gain in noncontaining infrabony defects.",2022,"Patients with a defect angle >22° showed significantly more CAL gain in the test group (t0-t1: 3.08 ± 1.38 mm; t0-t2: 3.62 ± 0.96 mm) than in the control group (t0-t1: 1.77 ± 1.54 mm; t0-t2: 2.18 ± 1.83 mm).
",['Forty patients exhibiting at least one infrabony defect with a probing pocket depth (PPD)\u2009≥6\u2009mm and a radiographic infrabony component (INFRA X-ray  )\u2009≥3\u2009mm'],"['granulation tissue preservation technique (GTPT', 'GTPT', 'granulation tissue preservation technique', 'GTPT (test group) or the double-flap approach with resection of the defect-filling granulation tissue (control group']","['CAL gain', 'Significant PPD reduction', 'PPD t0  and INFRA X-ray', 'Clinical and radiographic parameters', 'clinical attachment level (CAL) gain and more radiographic bone gain (RBG', 'CAL gain between t0 and t2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0034571', 'cui_str': 'radiography'}]","[{'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",40.0,0.063619,"Patients with a defect angle >22° showed significantly more CAL gain in the test group (t0-t1: 3.08 ± 1.38 mm; t0-t2: 3.62 ± 0.96 mm) than in the control group (t0-t1: 1.77 ± 1.54 mm; t0-t2: 2.18 ± 1.83 mm).
","[{'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Adam', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hüsamettin', 'Initials': 'H', 'LastName': 'Günay', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Vaske', 'Affiliation': 'Institute of Biostatistics, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Flohr', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Ingmar', 'Initials': 'I', 'LastName': 'Staufenbiel', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}]",Clinical and experimental dental research,['10.1002/cre2.532']
3523,35037730,"Marginal microleakage and modified microtensile bond strength of Activa Bioactive, in comparison with conventional restorative materials.","OBJECTIVES


This study aimed to assess the enamel and dentin marginal microleakage and dentin microtensile bond strength (μTBS) of ACTIVA BioACTIVE Restorative with and without a bonding agent compared with conventional restorative materials.
MATERIAL AND METHODS


For enamel and dentin microleakage, Class II boxes were prepared in the mesial (1 mm under the cementoenamel junction) and distal (1 mm above the cementoenamel junction) surfaces of 90 extracted human third molars. The teeth were randomly divided into five groups (n = 18): Group Z (G-Premio Bond + Filtek Z250 XT), Group X (G-Premio Bond + X-tra fil bulk-fill), Group AA (G-Premio Bond + Activa Bioactive restorative), Group A (Activa Bioactive restorative), and Group G (dentin conditioner + Fuji II LC Improve). The teeth were thermocycled, and their microleakage was quantified using the dye penetration test under a stereomicroscope. For dentin μTBS measurement, 12 specimens were fabricated in metal molds (1 × 1 × 12 mm³) for each group mentioned above, and a universal testing machine measured their μTBS. Data were analyzed using one-way analysis of variance (ANOVA), the Kruskal-Wallis test, and multiple comparisons tests.
RESULTS


Significant differences were noted among the groups in marginal microleakage and μTBS (p < .001). The highest mean microleakage scores at the enamel and dentin margins were noted in Group A, which had significant differences with other groups (p < .001). The highest μTBS was found in Group X, with significant differences with Group G and Group A (p < .05). The lowest µTBS was noted in Group A, with significant differences with Groups X, Group AA, and Group Z (p < .001).
CONCLUSIONS


Activa Bioactive without a bonding agent showed significantly lower µTBS to dentin, and higher microleakage at the enamel and dentin margins. Application of adhesive resin with Activa Bioactive provided a dentine bond strength and marginal seal comparable to other restorative materials.",2022,Application of adhesive resin with Activa Bioactive provided a dentine bond strength and marginal seal comparable to other restorative materials.,['For enamel and dentin microleakage'],"['Group Z (G-Premio Bond\u2009+\u2009Filtek Z250 XT), Group X (G-Premio Bond\u2009+\u2009X-tra fil bulk-fill), Group AA (G-Premio Bond\u2009+\u2009Activa Bioactive restorative), Group A (Activa Bioactive restorative), and Group G (dentin conditioner\u2009+\u2009Fuji II LC Improve']","['lowest µTBS', 'highest mean microleakage scores', 'marginal microleakage and μTBS', 'highest μTBS']","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0441859', 'cui_str': 'Group Z'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C1100855', 'cui_str': 'Filtek Z250'}, {'cui': 'C0441857', 'cui_str': 'Group X'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C4085648', 'cui_str': 'Tagalog language'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4309969', 'cui_str': 'ACTIVA BioACTIVE-RESTORATIVE'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0441841', 'cui_str': 'Group G'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0967990', 'cui_str': 'Fuji II LC cement improved'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}]",90.0,0.067063,Application of adhesive resin with Activa Bioactive provided a dentine bond strength and marginal seal comparable to other restorative materials.,"[{'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Tohidkhah', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Kermanshah', 'Affiliation': 'Department of Restorative Dentistry, Dental Research Center, Dentistry Institute, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Restorative Dentistry, Dental Research Center, Dentistry Institute, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnous', 'Initials': 'B', 'LastName': 'Jalalian', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Qom University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Ranjbar Omrani', 'Affiliation': 'Department of Restorative Dentistry, Dental Research Center, Dentistry Institute, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}]",Clinical and experimental dental research,['10.1002/cre2.534']
3524,35038612,Tranexamic acid for prevention of hemorrhage in elective repeat cesarean delivery-a randomized study.,"BACKGROUND


The American College of Obstetricians and Gynecologists states that the current data are insufficient to recommend tranexamic acid prophylaxis for postpartum hemorrhage.
OBJECTIVE


This study's objective was to evaluate if prophylactic tranexamic acid treatment reduces the calculated blood loss when compared with a placebo in women undergoing an elective repeat cesarean delivery.
STUDY DESIGN


This was a double-blind, randomized, placebo-controlled trial in which the calculated blood loss was determined after administration of prophylactic doses of 1 g of tranexamic acid before skin incision and after placental delivery and standard uterotonics in women with singleton pregnancies at ≥37 weeks' gestation presenting for their second or third cesarean delivery under neuraxial anesthesia. The primary outcome was calculated blood loss at 24 hours. The calculation was based on each participant's height, weight, and the difference in hematocrit before the start of surgery and 24 hours after delivery. Prespecified secondary outcomes were quantification of maternal coagulation activity during the perioperative course. A sample size of 50 women per group was planned (N=100) based on a meta-analysis of mean reduction in blood loss after tranexamic acid.
RESULTS


A total of 723 women were screened, and 110 women were randomized as follows: 55 to the tranexamic acid group and 55 to the placebo group. The primary outcome of mean calculated blood loss was 2274±469 mL for the tranexamic acid group and 2407±388 mL for the placebo group (P>.05). For the secondary outcomes, D-dimer levels were lower in the tranexamic acid group than in the placebo group 24 hours after delivery (2.1±1.2 µg/mL vs 4.3±2.4 µg/mL; P<.001).
CONCLUSION


Prophylactic tranexamic acid treatment did not decrease the mean calculated blood loss. Significantly less participants had a calculated blood loss >2000 mL in the tranexamic acid group than in the placebo group and had lower levels of D-dimer at 24 hours.",2022,Significantly less participants had calculated blood loss greater than 2000 mL in the tranexamic acid group compared to the placebo group with lower levels of D-dimer at 24 hours.,"['723 women were screened, and 110 women', 'Elective Repeat Cesarean', 'women undergoing elective repeat cesarean delivery', ""women with singleton pregnancies at least 37 weeks' gestation, presenting for their second or third cesarean delivery under neuraxial anesthesia""]","['placebo', '1-gram of TXA given before skin incision and after placental delivery and standard uterotonics', 'prophylactic TXA', 'Tranexamic Acid', 'tranexamic acid', 'Tranexamic acid (TXA) prophylaxis', 'Prophylactic tranexamic acid', 'TXA']","['mean calculated blood for TXA', 'mean calculated blood loss', 'quantification of maternal coagulation activity', 'D-dimer levels', 'calculated blood loss']","[{'cui': 'C4517866', 'cui_str': '723'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3653843', 'cui_str': 'UTEROTONICS'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",723.0,0.640909,Significantly less participants had calculated blood loss greater than 2000 mL in the tranexamic acid group compared to the placebo group with lower levels of D-dimer at 24 hours.,"[{'ForeName': 'Olutoyosi T', 'Initials': 'OT', 'LastName': 'Ogunkua', 'Affiliation': 'Departments of Anesthesiology and Pain Management (Drs Ogunkua, Eddins, and Klucsarits) and Obstetrics and Gynecology (Drs Duryea, Nelson, McIntire, and Leveno), The University of Texas Southwestern Medical Center, Dallas, TX.. Electronic address: Olutoyosi.Ogunkua@utsouthwestern.edu.'}, {'ForeName': 'Elaine L', 'Initials': 'EL', 'LastName': 'Duryea', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Nelson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Eddins', 'Affiliation': 'Departments of Anesthesiology and Pain Management (Drs Ogunkua, Eddins, and Klucsarits) and Obstetrics and Gynecology (Drs Duryea, Nelson, McIntire, and Leveno), The University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'Klucsarits', 'Affiliation': 'Departments of Anesthesiology and Pain Management (Drs Ogunkua, Eddins, and Klucsarits) and Obstetrics and Gynecology (Drs Duryea, Nelson, McIntire, and Leveno), The University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Donald D', 'Initials': 'DD', 'LastName': 'McIntire', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Leveno', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100573']
3525,34989105,Angiotensin-neprilysin inhibition and renal outcomes across the spectrum of ejection fraction in heart failure.,"AIMS


Patients with heart failure are at higher risk of progression to end-stage renal disease (ESRD), regardless of ejection fraction (EF). We assessed the renal effects of angiotensin-neprilysin inhibition in a pooled analysis of 13 195 patients with heart failure with reduced and preserved EF.
METHODS AND RESULTS


We combined data from PARADIGM-HF (EF ≤40%; n = 8399) and PARAGON-HF (EF ≥45%; n = 4796) in a pre-specified pooled analysis. We assessed the effect of treatment (sacubitril/valsartan vs. enalapril or valsartan) on a composite of either ≥50% reduction in estimated glomerular filtration rate (eGFR), ESRD, or death from renal causes, in addition to changes in eGFR slope. We assessed whether baseline renal function or EF modified the effect of therapy on renal outcomes. At randomization, eGFR was 68 ± 20 ml/min/1.73 m 2  in PARADIGM-HF and 63 ± 19 ml/min/1.73 m 2  in PARAGON-HF. The composite renal outcome occurred in 70 of 6594 patients (1.1%) in the sacubitril/valsartan group and in 123 of 6601 patients (1.9%) in the valsartan or enalapril group (hazard ratio 0.56, 95% confidence interval [CI] 0.42-0.75; p < 0.001). The mean eGFR change was -1.8 (95% CI -1.9 to -1.7) ml/min/1.73 m 2  /year for the sacubitril/valsartan group, compared with -2.4 (95% CI -2.5 to -2.2) ml/min/1.73 m 2  /year for the valsartan or enalapril group. The treatment effect on the composite renal endpoint was not modified by categories of baseline eGFR (p-interaction = 0.64), but was most pronounced in those with baseline EF between 30% and 60% (p-interaction = 0.001).
CONCLUSIONS


In patients with heart failure, sacubitril/valsartan reduced the risk of serious adverse renal outcomes and slowed decline in eGFR, compared with valsartan or enalapril, independent of baseline renal function.",2022,The mean eGFR change was -1.8 (95% CI -1.9 to -1.7),"['13\u2009195 patients with heart failure with reduced and preserved EF', 'Patients with heart failure are at higher risk of progression to end-stage renal disease (ESRD), regardless of ejection fraction (EF', 'heart failure']","['treatment (sacubitril/valsartan vs. enalapril or valsartan', 'valsartan or enalapril', 'angiotensin-neprilysin inhibition']","['risk of serious adverse renal outcomes', 'renal outcomes', 'estimated glomerular filtration rate (eGFR), ESRD, or death from renal causes', 'mean eGFR change', 'composite renal outcome']","[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0025250', 'cui_str': 'Lymphocyte antigen CD10'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",13195.0,0.152763,The mean eGFR change was -1.8 (95% CI -1.9 to -1.7),"[{'ForeName': 'Finnian R', 'Initials': 'FR', 'LastName': 'Mc Causland', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Azienda Ospedaliera Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Gori', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Azienda Ospedaliera Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Martina M', 'Initials': 'MM', 'LastName': 'McGrath', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Institut de Cardiologie de Montréal, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Shi', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Université de Lorraine, Inserm CIC1433, CHRU de Nancy, Nancy, France.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Azienda Ospedaliera Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}]",European journal of heart failure,['10.1002/ejhf.2421']
3526,34990896,Testing a self-compassion micro-intervention before appearance-based social media use: Implications for body image.,"Using social media applications can lead to increased body dissatisfaction among young women, particularly when they compare themselves to such images. One intervention for combating these harmful effects may be through self-compassion, or the ability to treat oneself as a friend. The goal of this study was to determine whether a self-compassion micro-intervention could prevent increases in body dissatisfaction after comparing themselves to thin ideal images on Instagram. In an online study, 230 women (M = 25.88, SD = 0.70) completed measures of state weight and appearance dissatisfaction before completing a brief self-compassion writing task (experimental condition) or a simple sorting task (control condition). After completing the assigned tasks, participants reported state body dissatisfaction. Next, they were asked to compare themselves to pre-selected thin ideal images of a curated Instagram profile before reporting state body dissatisfaction for a final time. The results demonstrated that the self-compassion intervention led to decreased in weight dissatisfaction and appearance dissatisfaction that were maintained after Instagram use. Those in the control condition showed increased in body image concern after Instagram use. These preliminary findings suggest that a self-compassion micro-intervention may serve as an effective buffer against certain adverse effects of social media on body image.",2022,"Using social media applications can lead to increased body dissatisfaction among young women, particularly when they compare themselves to such images.","['young women', '230 women (M = 25.88, SD = 0.70) completed measures of state weight and appearance dissatisfaction before completing a brief self-compassion writing task (experimental condition) or a simple sorting task (control condition']",['self-compassion micro-intervention'],"['weight dissatisfaction and appearance dissatisfaction', 'body image concern', 'body dissatisfaction']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}]",230.0,0.0054705,"Using social media applications can lead to increased body dissatisfaction among young women, particularly when they compare themselves to such images.","[{'ForeName': 'Keisha C', 'Initials': 'KC', 'LastName': 'Gobin', 'Affiliation': 'Department of Psychology, York University, 4700 Keele St, Toronto, ON M3J 1P3, Canada. Electronic address: kgobin@yorku.ca.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'McComb', 'Affiliation': 'Department of Psychology, York University, 4700 Keele St, Toronto, ON M3J 1P3, Canada.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Mills', 'Affiliation': 'Department of Psychology, York University, 4700 Keele St, Toronto, ON M3J 1P3, Canada.'}]",Body image,['10.1016/j.bodyim.2021.12.011']
3527,35041624,"A Single Fasting Exhaled Methane Level Correlates With Fecal Methanogen Load, Clinical Symptoms and Accurately Detects Intestinal Methanogen Overgrowth.","INTRODUCTION


A 2-hour breath test is the gold standard for diagnosing intestinal methanogen overgrowth (IMO). This method can be cumbersome especially if used repetitively to monitor treatment response. Therefore, we aimed to assess the reliability of a fasting single methane measurement (SMM) in diagnosing IMO and its utility as a biomarker to monitor treatment response in subjects with IMO.
METHODS


First, we calculated the test characteristics of SMM compared with lactulose and glucose breath test in 2 large-scale retrospective cohorts. Second, the symptomology associated with SMM using various cutoffs was analyzed. Third, in a double-blind randomized control trial, the temporal stability of SMM levels in subjects taking placebo was analyzed. Fourth, stool Methanobrevibacter smithii loads were quantified using quantitative polymerase chain reaction and compared with SMM levels. Last, the change in SMM over time during antibiotic therapy was analyzed.
RESULTS


Using the cutoff of SMM ≥10 ppm, SMM had a sensitivity of 86.4% and specificity of 100% for diagnosing IMO on the glucose and lactulose breath tests and was associated with constipation (5.65 ± 3.47 vs 4.32 ± 3.62, P = 0.008). SMM remained stable for 14 weeks without treatment (P = 0.45), and antibiotics lead to a decrease in SMM after 2 days (P < 0.0001). SMM was positively associate with stool M. smithii load (R = 0.65, P < 0.0001).
DISCUSSION


Fasting SMM ≥10 ppm seems to accurately diagnose IMO, is associated with constipation, and correlates with stool M. smithii. SMM seems to be stable without treatment and decreases after antibiotics. SMM may be a useful test to diagnose IMO and monitor treatment response.",2022,"SMM remained stable for 14 weeks without treatment (P = 0.45), and antibiotics lead to a decrease in SMM after 2 days (P < 0.0001).","['subjects with IMO', '2 large-scale retrospective cohorts', 'subjects taking']","['placebo', 'SMM', 'fasting single methane measurement (SMM']","['stool Methanobrevibacter smithii loads', 'SMM', 'SMM levels', 'glucose and lactulose breath tests', 'stool M. smithii load']","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0025621', 'cui_str': 'Methanobacteria'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0523769', 'cui_str': 'Methane measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0995875', 'cui_str': 'Methanobrevibacter smithii'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0523769', 'cui_str': 'Methane measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}]",,0.0917344,"SMM remained stable for 14 weeks without treatment (P = 0.45), and antibiotics lead to a decrease in SMM after 2 days (P < 0.0001).","[{'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Takakura', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pimentel', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, USA.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Augusta University, Augusta, USA.'}, {'ForeName': 'Maria Jesus', 'Initials': 'MJ', 'LastName': 'Villanueva-Millan', 'Affiliation': 'Medically Associated Science and Technology, Cedars-Sinai Medical Center, Los Angeles, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'Medically Associated Science and Technology, Cedars-Sinai Medical Center, Los Angeles, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Morales', 'Affiliation': 'Medically Associated Science and Technology, Cedars-Sinai Medical Center, Los Angeles, USA.'}, {'ForeName': 'Maritza', 'Initials': 'M', 'LastName': 'Sanchez', 'Affiliation': 'Medically Associated Science and Technology, Cedars-Sinai Medical Center, Los Angeles, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Torosyan', 'Affiliation': 'Medically Associated Science and Technology, Cedars-Sinai Medical Center, Los Angeles, USA.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Rashid', 'Affiliation': 'Medically Associated Science and Technology, Cedars-Sinai Medical Center, Los Angeles, USA.'}, {'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Hosseini', 'Affiliation': 'Medically Associated Science and Technology, Cedars-Sinai Medical Center, Los Angeles, USA.'}, {'ForeName': 'Jiajing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Medically Associated Science and Technology, Cedars-Sinai Medical Center, Los Angeles, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Leite', 'Affiliation': 'Medically Associated Science and Technology, Cedars-Sinai Medical Center, Los Angeles, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Kowalewski', 'Affiliation': 'Research Informatics and Scientific Computing Core, Cedars-Sinai Medical Center, Los Angeles, USA.'}, {'ForeName': 'Ruchi', 'Initials': 'R', 'LastName': 'Mathur', 'Affiliation': 'Medically Associated Science and Technology, Cedars-Sinai Medical Center, Los Angeles, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rezaie', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, USA.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000001607']
3528,35043553,Peri-implant soft-tissue esthetic outcome after immediate implant placement in conjunction with xenogeneic acellular dermal matrix or connective tissue graft: A randomized controlled clinical study.,"OBJECTIVES


This randomized comparative study evaluated the clinical esthetic outcome of the peri-implant mucosa following extraction and immediate implant placement in conjunction with anorganic bovine bone mineral (ABBM) and the use of a porcine acellular dermal matrix (pADM) versus an autogenous connective tissue graft (CTG) in the anterior maxilla.
MATERIALS AND METHODS


Twenty patients (11 men, 9 women) with a mean age of 48,9 years (range 21-72) were included in the study and randomly assigned to either the test (pADM) or control group (CTG). They underwent extraction and immediate implant placement together with ABBM for socket grafting and either pADM or CTG for soft tissue augmentation. Twelve months after implant placement color measurements of the peri-implant mucosa and a reference tooth were performed using a spectophotometer and the color difference (ΔE) was calculated. The overall esthetic appearance of the peri-implant soft tissue was evaluated using the Pink Esthetic Score (PES). Statistical analysis was performed using Student's T-Test, the alpha was set to 0.05.
RESULTS


All implants received osseointegration and were restored. The mean color difference of the peri-implant mucosa 1 year after surgery amounted ΔE 4.06 ± 1.6 for the test group (pADM) and ΔE 3.58 ± 1.36 mm for the control group (CTG), showing no statistically significant difference (p = 0.47). The mean PES of the pADM group was 11.4 ± 1.4 and for the CTG group 10.7 ± 1.5, showing no statistically significant difference (p = 0.29).
CONCLUSION


Twelve months after surgery, a porcine acellular dermal matrix for soft tissue augmentation in conjunction with immediate implant placement showed no difference in the overall esthetic appearance regarding color match and Pink Esthetic Score in comparison to autogenous soft tissue graft.
CLINICAL SIGNIFICANCE


Connective tissue grafts have become a standard in order to enhance the soft tissue quality and esthetic appearance in immediate implant placement. The use of new biomaterials like porcine acellular dermal matrices may avoid the need to harvest autogenous grafts resulting in simplified treatment and less postoperative morbidity.",2022,"1 year after surgery amounted ΔE 4.06 ± 1.6 for the test group (pADM) and ΔE 3.58 ± 1.36 mm for the control group (CTG), showing no statistically significant difference (p = 0.47).","['Twenty patients (11 men, 9 women) with a mean age of 48,9\u2009years (range 21-72']","['anorganic bovine bone mineral (ABBM', 'xenogeneic acellular dermal matrix or connective tissue graft', 'peri-implant mucosa following extraction and immediate implant placement', 'porcine acellular dermal matrix (pADM', 'test (pADM) or control group (CTG', 'pADM or CTG', 'autogenous connective tissue graft (CTG']","['mean PES', 'overall esthetic appearance', 'overall esthetic appearance regarding color match and Pink Esthetic Score', 'postoperative morbidity', 'mean color difference of the peri-implant mucosa', 'Pink Esthetic Score (PES']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C3494272', 'cui_str': 'Acellular Dermal Matrix'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}]",72.0,0.0269006,"1 year after surgery amounted ΔE 4.06 ± 1.6 for the test group (pADM) and ΔE 3.58 ± 1.36 mm for the control group (CTG), showing no statistically significant difference (p = 0.47).","[{'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Happe', 'Affiliation': 'Dr. Happe & Kollegen, Münster, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Münster, Münster, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Neugebauer', 'Affiliation': 'Department of Oral and Maxillofacial Plastic Surgery, University of Cologne, Köln, Germany.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12866']
3529,35007642,Impact of physical exercise on depression and anxiety in adolescent inpatients: A randomized controlled trial.,"BACKGROUND


Physical exercise therapy is of proven efficacy in the treatment of adults with depression, but corresponding evidence is lacking in depressed adolescent inpatients. The aim of this study was to document the effect of add-on treatment with structured physical exercise in a clinical population of adolescents hospitalized for depression and anxiety in a psychiatric hospital.
METHODS


A group of 52 adolescent inpatients was randomly assigned to a physical exercise or control program three to four times per week over a six-week period (20 hours in total). The primary outcome was the Hospital Anxiety Depression Scale (HADS) for evaluation of depression and anxiety symptoms. Secondary outcomes were psychological self-assessments, diagnostic interviews, and physical examinations.
RESULTS


Six participants were lost in each group, leaving 20 inpatients each in the intervention and control groups. A linear mixed model with F-test revealed a significant interaction in favor of physical exercise in reducing the mean depression score (HADS-D) by 3.8 points [95% (CI), range 1.8 to 5.7], compared to a mean reduction score of 0.7 [95% (CI), range -0,7 to 2.0] in the control group. No significant interaction was found for anxiety symptoms (HADS-A).
LIMITATIONS


The investigation was limited to the six-week hospital window and the small sample size prevented exploring differences in social characteristics.
CONCLUSION


Structured physical exercise add-on therapy integrated into the psychiatric hospitalization of adolescents has led to a reduction in their depressive symptoms, demonstrating its effectiveness in the care of adolescent inpatients with depression.",2022,A group of 52 adolescent inpatients was randomly assigned to a physical exercise or control program three to four times per week over a six-week period (20 hours in total).,"['adolescent inpatients', 'adolescent inpatients with depression', 'depressed adolescent inpatients', 'adolescents hospitalized for depression and anxiety in a psychiatric hospital', 'adults with depression', '52 adolescent inpatients']","['physical exercise', 'physical exercise or control program', 'Structured physical exercise', 'Physical exercise therapy', 'structured physical exercise']","['depression and anxiety', 'anxiety symptoms (HADS-A', 'Hospital Anxiety Depression Scale (HADS) for evaluation of depression and anxiety symptoms', 'mean depression score (HADS-D', 'psychological self-assessments, diagnostic interviews, and physical examinations']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0451107', 'cui_str': 'Depression anxiety scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",6.0,0.0587364,A group of 52 adolescent inpatients was randomly assigned to a physical exercise or control program three to four times per week over a six-week period (20 hours in total).,"[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Philippot', 'Affiliation': 'MSL-In Laboratory, Institute of Neuroscience, Université Catholique de Louvain, Brussels, Belgium; Psychiatric Hospital Area+/Epsylon, ASBL, Brussels, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Dubois', 'Affiliation': 'Psychiatric Hospital Area+/Epsylon, ASBL, Brussels, Belgium.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Lambrechts', 'Affiliation': 'Psychiatric Hospital Area+/Epsylon, ASBL, Brussels, Belgium; Environmental, Aging (Integrative) Physiology Laboratory, Haute Ecole Bruxelles-Brabant (HE2B), Brussels, Belgium.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Grogna', 'Affiliation': 'Psychiatric Hospital Area+/Epsylon, ASBL, Brussels, Belgium.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Robert', 'Affiliation': 'EPID Epidemiology and Biostatistics Research Pole Environmental, Institut de recherche expérimentale et clinique, Université catholique de Louvain.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Jonckheer', 'Affiliation': 'Psychiatric Hospital Area+/Epsylon, ASBL, Brussels, Belgium.'}, {'ForeName': 'Wagdan', 'Initials': 'W', 'LastName': 'Chakib', 'Affiliation': 'Psychiatric Hospital Area+/Epsylon, ASBL, Brussels, Belgium.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Beine', 'Affiliation': 'Psychiatric Hospital Area+/Epsylon, ASBL, Brussels, Belgium.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Bleyenheuft', 'Affiliation': 'MSL-In Laboratory, Institute of Neuroscience, Université Catholique de Louvain, Brussels, Belgium. Electronic address: yannick.bleyenheuft@uclouvain.be.'}, {'ForeName': 'Anne G', 'Initials': 'AG', 'LastName': 'De Volder', 'Affiliation': 'MSL-In Laboratory, Institute of Neuroscience, Université Catholique de Louvain, Brussels, Belgium; Pediatric Neurology Service, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}]",Journal of affective disorders,['10.1016/j.jad.2022.01.011']
3530,35014755,Does polishing of bleached enamel affect roughness and tooth color stability after exposure to coffee?,"OBJECTIVE


This laboratory randomized study was designed to evaluate the effect of polishing on roughness and color stability of bleached teeth after coffee immersion.
MATERIALS AND METHODS


Ninety bovine crowns were randomly allocated to six groups (n = 15), according to bleaching protocols: At-home: standard protocol using 10% hydrogen peroxide (HP) or In-office: standard protocol using 35% HP; and with polishing protocols: (1) no polishing, (2) bleached enamel polished with #0.5 μm or (3) #2-4 μm diamond particles grit pastes. Samples were daily immersed into coffee solution for 45 min followed by mechanical brushing simulation (30 s) for 30 days. The surface roughness (Ra) and color alteration, expressed by ΔE ab  , ΔE 00  , and whitening index (WI) were analyzed at baseline, after bleaching/polishing protocols and after coffee solution staining. The surface from each group was examined using a scanning electron microscope. Data were analyzed by two-way repeated measure analysis of variance followed by the Tukey test (α = 0.05).
RESULTS


Staining increases Ra, ΔE ab  , ΔE 00  , and decreases WI values. Polishing after bleaching did not prevent staining, however, tooth polished with #0.5 μ-grit polishing paste showed better performance than #2-4 μ-grit (ΔE ab  : p = 0.001/ΔE 00  : p = 0.003). Scanning electron microscope revealed a more irregular surface after coffee staining for all groups regardless bleaching/polishing protocols.
CONCLUSIONS


Using #0.5 μ-grit diamond paste to polish 35%HP in-office bleached enamel reduces the roughness and tooth staining. However, polishing after 10%HP at-home bleached enamel neither affects roughness nor improves tooth color stability after exposure to coffee.
CLINICAL SIGNIFICANCE


Polishing after at-home bleaching does not have benefits but after 35% hydrogen peroxide in-office bleaching, the polishing with #0.5 μ-grit polishing paste is indicated to reduce roughness and the tooth staining over time.",2022,"Scanning electron microscope revealed a more irregular surface after coffee staining for all groups regardless bleaching/polishing protocols.
","['0.001/ΔE 00  ', 'Ninety bovine crowns']","['bleaching protocols: At-home: standard protocol using 10% hydrogen peroxide (HP) or In-office: standard protocol using 35% HP; and with polishing protocols: (1) no polishing, (2) bleached enamel polished with #0.5\xa0μm or (3) #2-4\xa0μm diamond particles grit pastes', 'hydrogen peroxide']","['surface roughness (Ra) and color alteration, expressed by ΔE ab  , ΔE 00  , and whitening index (WI', 'tooth color stability', 'roughness and tooth staining']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0010384', 'cui_str': 'Crown'}]","[{'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0440273', 'cui_str': 'Grit'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0475833', 'cui_str': 'Tooth color'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040434', 'cui_str': 'Staining of tooth'}]",90.0,0.07189,"Scanning electron microscope revealed a more irregular surface after coffee staining for all groups regardless bleaching/polishing protocols.
","[{'ForeName': 'Roberta Furtado', 'Initials': 'RF', 'LastName': 'Carvalho', 'Affiliation': 'Dental School, CEUMA University, São Luis, Brazil.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'da Mata Galvão', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Murilo Guimarães', 'Initials': 'MG', 'LastName': 'Campolina', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Ludmila Cavalcanti', 'Initials': 'LC', 'LastName': 'de Mendonça', 'Affiliation': 'Technical School of Health, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Carlos José', 'Initials': 'CJ', 'LastName': 'Soares', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'Ceci Nunes', 'Initials': 'CN', 'LastName': 'Carvalho', 'Affiliation': 'Dental School, CEUMA University, São Luis, Brazil.'}, {'ForeName': 'Gisele Rodrigues', 'Initials': 'GR', 'LastName': 'da Silva', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Brazil.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12869']
3531,35016188,Clinical Utility of KidneyIntelX in Early Stages of Diabetic Kidney Disease in the CANVAS Trial.,"INTRODUCTION


KidneyIntelX is a composite risk score, incorporating biomarkers and clinical variables for predicting progression of diabetic kidney disease (DKD). The utility of this score in the context of sodium glucose co-transporter 2 inhibitors and how changes in the risk score associate with future kidney outcomes are unknown.
METHODS


We measured soluble tumor necrosis factor receptor (TNFR)-1, soluble TNFR-2, and kidney injury molecule 1 on banked samples from CANagliflozin cardioVascular Assessment Study (CANVAS) trial participants with baseline DKD (estimated glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m2 or urine albumin-to-creatinine ratio [UACR] ≥30 mg/g) and generated KidneyIntelX risk scores at baseline and years 1, 3, and 6. We assessed the association of baseline and changes in KidneyIntelX with subsequent DKD progression (composite outcome of an eGFR decline of ≥5 mL/min/year [using the 6-week eGFR as the baseline in the canagliflozin group], ≥40% sustained decline in the eGFR, or kidney failure).
RESULTS


We included 1,325 CANVAS participants with concurrent DKD and available baseline plasma samples (mean eGFR 65 mL/min/1.73 m2 and median UACR 56 mg/g). During a mean follow-up of 5.6 years, 131 participants (9.9%) experienced the composite kidney outcome. Using risk cutoffs from prior validation studies, KidneyIntelX stratified patients to low- (42%), intermediate- (44%), and high-risk (15%) strata with cumulative incidence for the outcome of 3%, 11%, and 26% (risk ratio 8.4; 95% confidence interval [CI]: 5.0, 14.2) for the high-risk versus low-risk groups. The differences in eGFR slopes for canagliflozin versus placebo were 0.66, 1.52, and 2.16 mL/min/1.73 m2 in low, intermediate, and high KidneyIntelX risk strata, respectively. KidneyIntelX risk scores declined by 5.4% (95% CI: -6.9, -3.9) in the canagliflozin arm at year 1 versus an increase of 6.3% (95% CI: 3.8, 8.7) in the placebo arm (p < 0.001). Changes in the KidneyIntelX score at year 1 were associated with future risk of the composite outcome (odds ratio per 10 unit decrease 0.80; 95% CI: 0.77, 0.83; p < 0.001) after accounting for the treatment arm, without evidence of effect modification by the baseline KidneyIntelX risk stratum or by the treatment arm.
CONCLUSIONS


KidneyIntelX successfully risk-stratified a large multinational external cohort for progression of DKD, and greater numerical differences in the eGFR slope for canagliflozin versus placebo were observed in those with higher baseline KidneyIntelX scores. Canagliflozin treatment reduced KidneyIntelX risk scores over time and changes in the KidneyIntelX score from baseline to 1 year associated with future risk of DKD progression, independent of the baseline risk score and treatment arm.",2022,"KidneyIntelX risk scores declined by 5.4% (95% CI: -6.9, -3.9) in the canagliflozin arm at year 1 versus an increase of 6.3% (95% CI: 3.8, 8.7) in the placebo arm (p < 0.001).","['participants with baseline DKD (estimated glomerular filtration rate [eGFR] 30-59 mL', '≥30', '1,325 CANVAS participants with concurrent DKD and available baseline plasma samples (mean eGFR 65 mL/min/1.73 m2 and median']","['placebo', 'canagliflozin versus placebo', 'Canagliflozin', 'KidneyIntelX']","['eGFR slope', 'soluble tumor necrosis factor receptor (TNFR)-1, soluble TNFR-2, and kidney injury molecule', 'KidneyIntelX score', 'urine albumin-to-creatinine ratio [UACR', 'KidneyIntelX risk scores', 'eGFR slopes', 'eGFR, or kidney failure', 'generated KidneyIntelX risk scores', 'composite kidney outcome']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}, {'cui': 'C0255813', 'cui_str': 'Lymphocyte antigen CD120B'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1325.0,0.576673,"KidneyIntelX risk scores declined by 5.4% (95% CI: -6.9, -3.9) in the canagliflozin arm at year 1 versus an increase of 6.3% (95% CI: 3.8, 8.7) in the placebo arm (p < 0.001).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lam', 'Affiliation': 'Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Girish N', 'Initials': 'GN', 'LastName': 'Nadkarni', 'Affiliation': 'Division of Nephrology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Gohar', 'Initials': 'G', 'LastName': 'Mosoyan', 'Affiliation': 'Division of Nephrology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Department of Medicine, Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Rosenthal', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Hansen', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Fleming', 'Affiliation': 'Renalytix AI, PLC, New York, New York, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Coca', 'Affiliation': 'Division of Nephrology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}]",American journal of nephrology,['10.1159/000519920']
3532,35019219,A 5-year randomized controlled clinical trial comparing 4-mm ultrashort to longer implants placed in regenerated bone in the posterior atrophic jaw.,"BACKGROUND


Short implants (up to 5-mm long) have shown good results when compared to longer implants placed in augmented bone.
PURPOSE


To evaluate if 4-mm ultrashort implants could also be an alternative to bone augmentation in the severely atrophic posterior jaws. The primary aim of the study was to compare implant survival rates between study groups.
MATERIALS AND METHODS


Eighty partially edentulous patients with posterior atrophic jaws (5-6 mm of bone above the mandibular canal and 4-5 mm below the maxillary sinus) were included: 40 patients in the maxilla and 40 in mandible. The patients were randomized to receive one to three 4-mm ultrashort implants or one to three implants at least 10-mm long in augmented bone. Results are reported 5 years after loading with the following outcome measures: implant and prosthetic failures, complications and peri-implant marginal bone level changes.
RESULTS


Thirty-two complications were reported for the control group in 18 patients versus 13 complications in 10 patients in the test group, the difference being not statistically significant (p = 0.103). In the augmented group, 12 implants failed in 6 patients versus 7 short implants in 6 cases, and 9 prostheses failed in the control group while 4 in the test one, without statistically significant differences (p = 1.000 and 0.363, respectively). At 5 years after loading, short implants lost on average 0.58 ± 0.40 mm of peri-implant marginal bone and long implants 0.99 ± 0.58 mm, the difference was statistically significant (p = 0.006).
CONCLUSION


Four-millimeter ultrashort implants showed similar if not better results when compared to longer implants placed in augmented jaws 5 years after loading. For this reason, their use could be in specific cases preferable to bone augmentation since the treatment is less invasive, faster, cheaper and associated with less morbidity. However, longer follow-ups and larger trials are needed.",2022,Four-millimeter ultrashort implants showed similar if not better results when compared to longer implants placed in augmented jaws 5 years after loading.,"['Eighty partially edentulous patients with posterior atrophic jaws (5-6\u2009mm of bone above the mandibular canal and 4-5\u2009mm below the maxillary sinus) were included: 40 patients in the maxilla and 40 in mandible', 'severely atrophic posterior jaws']",['ultrashort implants or one to three implants at least 10-mm long in augmented bone'],"['prosthetic failures, complications and peri-implant marginal bone level changes', 'implant survival rates']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0222756', 'cui_str': 'Structure of mandibular canal'}, {'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",80.0,0.0407438,Four-millimeter ultrashort implants showed similar if not better results when compared to longer implants placed in augmented jaws 5 years after loading.,"[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Barausse', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Unit of Oral Surgery, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pistilli', 'Affiliation': 'Oral and Maxillofacial Unit, San Camillo Hospital, Rome, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Canullo', 'Affiliation': 'Department of Periodontology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Bonifazi', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Unit of Oral Surgery, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Agnese', 'Initials': 'A', 'LastName': 'Ferri', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Unit of Oral Surgery, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Felice', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Unit of Oral Surgery, University of Bologna, Bologna, Italy.'}]",Clinical implant dentistry and related research,['10.1111/cid.13061']
3533,34862248,Safety and Efficacy of Pembrolizumab in Combination with Acalabrutinib in Advanced Head and Neck Squamous Cell Carcinoma: Phase 2 Proof-of-Concept Study.,"PURPOSE


Programmed cell death-1 (PD-1) receptor inhibitors have shown efficacy in head and neck squamous cell carcinoma (HNSCC), but treatment failure or secondary resistance occurs in most patients. In preclinical murine carcinoma models, inhibition of Bruton's tyrosine kinase (BTK) induces myeloid cell reprogramming that subsequently bolsters CD8+ T cell responses, resulting in enhanced antitumor activity. This phase 2, multicenter, open-label, randomized study evaluated pembrolizumab (anti-PD-1 monoclonal antibody) plus acalabrutinib (BTK inhibitor) in recurrent or metastatic HNSCC.
PATIENTS AND METHODS


Patients received pembrolizumab 200 mg intravenously every 3 weeks, alone or in combination with acalabrutinib 100 mg orally twice daily. Safety and overall response rate (ORR) were co-primary objectives. The secondary objectives were progression-free survival (PFS) and overall survival.
RESULTS


Seventy-six patients were evaluated (pembrolizumab, n = 39; pembrolizumab + acalabrutinib, n = 37). Higher frequencies of grade 3-4 treatment-emergent adverse events (AE; 65% vs. 39%) and serious AEs (68% vs. 31%) were observed with combination therapy versus monotherapy. ORR was 18% with monotherapy versus 14% with combination therapy. Median PFS was 2.7 [95% confidence interval (CI), 1.4-6.8] months in the combination arm and 1.7 (95% CI, 1.4-4.0) months in the monotherapy arm. The study was terminated due to lack of clinical benefit with combination treatment. To assess how tumor immune contexture was affected by therapy in patients with pre- and post-treatment biopsies, spatial proteomic analyses were conducted that revealed a trend toward increased CD45+ leukocyte infiltration of tumors from baseline at day 43 with pembrolizumab (monotherapy, n = 5; combination, n = 2), which appeared to be higher in combination-treated patients; however, definitive conclusions could not be drawn due to limited sample size.
CONCLUSIONS


Despite lack of clinical efficacy, immune subset analyses suggest that there are additive effects of this combination; however, the associated toxicity limits the feasibility of combination treatment with pembrolizumab and acalabrutinib in patients with recurrent or metastatic HNSCC.",2022,"Median PFS was 2.7 [95% confidence interval (CI), 1.4-6.8] months in the combination arm and 1.7 (95% CI, 1.4-4.0) months in the monotherapy arm.","['head and neck squamous cell carcinoma (HNSCC', 'patients with recurrent or metastatic HNSCC', 'patients with pre- and post-treatment biopsies, spatial proteomic analyses', 'recurrent or metastatic HNSCC', 'Seventy-six patients were evaluated (pembrolizumab,  n  = 39; pembrolizumab + acalabrutinib,  n  = 37', 'Advanced Head and Neck Squamous Cell Carcinoma']","['pembrolizumab', 'pembrolizumab (monotherapy', 'Pembrolizumab', 'pembrolizumab 200 mg intravenously every 3 weeks, alone or in combination with acalabrutinib 100 mg orally twice daily', 'pembrolizumab (anti-PD-1 monoclonal antibody) plus acalabrutinib (BTK inhibitor']","['Safety and Efficacy', 'serious AEs', 'progression-free survival (PFS) and overall survival', 'Safety and overall response rate (ORR', 'ORR', 'Median PFS']","[{'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0744620', 'cui_str': 'Squamous cell carcinoma of head and neck metastatic'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0872252', 'cui_str': 'Proteomics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C4078312', 'cui_str': 'acalabrutinib'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C4530084', 'cui_str': 'acalabrutinib 100 MG'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4078312', 'cui_str': 'acalabrutinib'}, {'cui': 'C4521488', 'cui_str': 'Non-specific protein-tyrosine kinase inhibitor'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",76.0,0.212466,"Median PFS was 2.7 [95% confidence interval (CI), 1.4-6.8] months in the combination arm and 1.7 (95% CI, 1.4-4.0) months in the monotherapy arm.","[{'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Taylor', 'Affiliation': 'Division of Hematology and Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Courtney B', 'Initials': 'CB', 'LastName': 'Betts', 'Affiliation': 'Department of Cell, Developmental, and Cancer Biology, Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Maloney', 'Affiliation': 'Division of Hematology and Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Nadler', 'Affiliation': 'Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Algazi', 'Affiliation': 'University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Guarino', 'Affiliation': 'Helen F. Graham Cancer Center and Research Institute, Newark, Delaware.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nemunaitis', 'Affiliation': 'University of Toledo College of Medicine and Life Sciences, and ProMedica Health System, Toledo, Ohio.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Jimeno', 'Affiliation': 'University of Colorado Cancer Center, Denver, Colorado.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'AstraZeneca, South San Francisco, California.'}, {'ForeName': 'Veerendra', 'Initials': 'V', 'LastName': 'Munugalavadla', 'Affiliation': 'AstraZeneca, South San Francisco, California.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'AstraZeneca, South San Francisco, California.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Adkins', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Goldschmidt', 'Affiliation': 'Blue Ridge Cancer Care, Blacksburg, Virginia.'}, {'ForeName': 'Ezra E W', 'Initials': 'EEW', 'LastName': 'Cohen', 'Affiliation': 'University of California San Diego, Moores Cancer Center, La Jolla, California.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Coussens', 'Affiliation': 'Department of Cell, Developmental, and Cancer Biology, Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-2547']
3534,34896069,An Electronic Health Record Integrated Decision Tool and Supportive Interventions to Improve Antibiotic Prescribing for Urinary Tract Infections in Nursing Homes: A Cluster Randomized Controlled Trial.,"OBJECTIVE


To investigate whether an electronic health record (EHR)-integrated decision tool, combined with supportive interventions, results in more appropriate antibiotic prescribing in nursing home (NH) residents with suspected urinary tract infection (UTI), without negative consequences for residents.
DESIGN


Cluster randomized controlled trial with NHs as the randomization unit; intervention group NHs received the EHR-integrated decision tool and supportive interventions, and control group NHs provided care as usual.
SETTING AND PARTICIPANTS


212 residents with suspected UTI, from 16 NHs in the Netherlands.
METHODS


Physicians collected data at index consultation (ie, UTI suspicion) and during a 21-day follow-up period (March 2019-March 2020). Overall antibiotic prescribing data at NH level, 12 months prior to and during the study, was derived from the electronic prescribing system. The primary study outcome was the percentage of antibiotic prescriptions for suspected UTI that was appropriate, at index consultation. Secondary study outcomes included changes in treatment decision, complications, UTI-related hospitalization, and mortality during follow-up; and pre-post study changes in antibiotic prescribing at the NH level.
RESULTS


295 suspected UTIs were included (intervention group: 189; control group: 106). The between-group difference in appropriate antibiotic prescribing was 13% [intervention group: 62%, control group: 49%; adjusted odds ratio (OR) 1.43, 95% CI 0.57-3.62]. In both groups, complications (2% vs 3%), UTI-related hospitalization (2% vs 1%), and possible UTI-related mortality (2% vs 2%) were rare. The pre-post study difference in antibiotic prescriptions per 1000 resident-care days was -0.95 in the intervention group NHs and -0.05 in the control group NHs (P = .02).
CONCLUSION AND IMPLICATIONS


Although appropriate antibiotic prescribing improved in the intervention group, this does not provide sufficient evidence for our multidisciplinary intervention. Despite this inconclusive result, our intervention could potentially still be effective, because we established a large reduction in the number of antibiotic prescriptions in the intervention group.",2022,"The pre-post study difference in antibiotic prescriptions per 1000 resident-care days was -0.95 in the intervention group NHs and -0.05 in the control group NHs (P = .02).
","['nursing home (NH) residents with suspected urinary tract infection (UTI), without negative consequences for residents', '295 suspected UTIs were included (intervention group: 189; control group: 106', 'Physicians collected data at index consultation (ie, UTI suspicion) and during a 21-day follow-up period (March 2019-March 2020', 'Nursing Homes', '212 residents with suspected UTI, from 16 NHs in the Netherlands']","['Antibiotic Prescribing', 'EHR-integrated decision tool and supportive interventions, and control group NHs provided care as usual', 'electronic health record (EHR)-integrated decision tool, combined with supportive interventions']","['appropriate antibiotic prescribing', 'complications', 'changes in treatment decision, complications, UTI-related hospitalization, and mortality during follow-up; and pre-post study changes in antibiotic prescribing at the NH level', 'UTI-related hospitalization', 'percentage of antibiotic prescriptions for suspected UTI', 'possible UTI-related mortality', 'antibiotic prescriptions']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1277624', 'cui_str': 'Suspected UTI (urinary tract infection)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C1277624', 'cui_str': 'Suspected UTI (urinary tract infection)'}, {'cui': 'C0332149', 'cui_str': 'Possible'}]",212.0,0.0691036,"The pre-post study difference in antibiotic prescriptions per 1000 resident-care days was -0.95 in the intervention group NHs and -0.05 in the control group NHs (P = .02).
","[{'ForeName': 'Jeanine J S', 'Initials': 'JJS', 'LastName': 'Rutten', 'Affiliation': 'Department of Medicine for Older People, Amsterdam Public Health Research Institute, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Laura W', 'Initials': 'LW', 'LastName': 'van Buul', 'Affiliation': 'Department of Medicine for Older People, Amsterdam Public Health Research Institute, Amsterdam University Medical Centers, Amsterdam, the Netherlands. Electronic address: L.vanbuul@amsterdamumc.nl.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Smalbrugge', 'Affiliation': 'Department of Medicine for Older People, Amsterdam Public Health Research Institute, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Geerlings', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Debby L', 'Initials': 'DL', 'LastName': 'Gerritsen', 'Affiliation': 'Radboud Institute for Health Sciences, Radboudumc Alzheimer Center, Department of Primary and Community care, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Natsch', 'Affiliation': 'Department of Pharmacy, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Sloane', 'Affiliation': 'Department of Family Medicine, School of Medicine, and the Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Department of Medicine for Older People, Amsterdam Public Health Research Institute, Amsterdam University Medical Centers, Amsterdam, the Netherlands; Department of General Practice, Amsterdam Public Health Research Institute, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Cees M P M', 'Initials': 'CMPM', 'LastName': 'Hertogh', 'Affiliation': 'Department of Medicine for Older People, Amsterdam Public Health Research Institute, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2021.11.010']
3535,34889140,Burden and Heart Rate Variability in Bipolar Disorder Family Caregivers.,"Family caregivers of persons with bipolar disorder experience considerable stress. Yet, studies have not examined whether their stress differs by race and gender. This preliminary analysis of baseline data from 228 African American and White family caregivers of adults with bipolar disorder who were enrolled in a randomized controlled trial examined race and gender differences on two validated self-report measures of psychological stress (caregiver burden and caregiver reactions) and an electrocardiography device used to capture heart rate variability (HRV). No statistically significant differences were found by race or gender on either measure of psychological stress. African American caregivers had significantly lower scores on two indices of HRV compared to White caregivers. Women had significantly lower scores on one index of HRV compared to men. Low HRV indicates greater stress and mortality risk. Future research should include HRV to measure caregiver stress and implement relevant interventions.",2022,African American caregivers had significantly lower scores on two indices of HRV compared to White caregivers.,"['228 African American and White family caregivers of adults with bipolar disorder', 'African American caregivers', 'Bipolar Disorder Family Caregivers', 'Family caregivers of persons with bipolar disorder experience considerable stress']",[],"['psychological stress (caregiver burden and caregiver reactions) and an electrocardiography device used to capture heart rate variability (HRV', 'index of HRV', 'psychological stress', 'Burden and Heart Rate Variability', 'stress and mortality risk']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",[],"[{'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1298904', 'cui_str': 'Device used'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",228.0,0.168352,African American caregivers had significantly lower scores on two indices of HRV compared to White caregivers.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Williams', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Jaclene A', 'Initials': 'JA', 'LastName': 'Zauszniewski', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}]",Western journal of nursing research,['10.1177/01939459211063660']
3536,35037473,Daily protein-polyphenol ingestion increases daily myofibrillar protein synthesis rates and promotes early muscle functional gains during resistance training.,"Factors underpinning the time-course of resistance-type exercise training (RET) adaptations are not fully understood. This study hypothesized that consuming a twice-daily protein-polyphenol beverage (PPB;  n  = 15; age, 24 ± 1 yr; BMI, 22.3 ± 0.7 kg·m -2 ) previously shown to accelerate recovery from muscle damage and increase daily myofibrillar protein synthesis (MyoPS) rates would accelerate early (10 sessions) improvements in muscle function and potentiate quadriceps volume and muscle fiber cross-sectional area (fCSA) following 30 unilateral RET sessions in healthy, recreationally active, adults. Versus isocaloric placebo (PLA;  n  = 14; age, 25 ± 2 yr; BMI, 23.9 ± 1.0 kg·m -2 ), PPB increased 48 h MyoPS rates after the first RET session measured using deuterated water (2.01 ± 0.15 vs. 1.51 ± 0.16%·day -1 , respectively;  P  < 0.05). In addition, PPB increased isokinetic muscle function over 10 sessions of training relative to the untrained control leg (%U) from 99.9 ± 1.8 pretraining to 107.2 ± 2.4%U at  session 10  (vs. 102.6 ± 3.9 to 100.8 ± 2.4%U at  session 10  in PLA; interaction  P  < 0.05). Pre to posttraining, PPB increased type II fCSA (PLA: 120.8 ± 8.2 to 109.5 ± 8.6%U; PPB: 92.8 ± 6.2 to 108.4 ± 9.7%U; interaction  P  < 0.05), but the gain in quadriceps muscle volume was similar between groups. Similarly, PPB did not further increase peak isometric torque, muscle function, or MyoPS measured posttraining. This suggests that although PPB increases MyoPS and early adaptation, it may not influence longer term adaptations to unilateral RET. NEW & NOTEWORTHY  Using a unilateral model of resistance training, we show for the first time that a protein-polyphenol beverage increases initial rates of myofibrillar protein synthesis and promotes early functional improvements. Following a prolonged period of training, this strategy also increases type II fiber hypertrophy and causes large individual variation in gains in quadricep muscle cross-sectional area.",2022,"Additionally, PPB increased isokinetic muscle function over 10 sessions of training relative to the untrained control leg (%U) from 99.9 ± 1.8 pre-training to 107.2 ± 2.4 %U at session 10 (versus 102.6 ± 3.9 to 100.8 ± 2.4 %U at session 10 in PLA; interaction P<0.05).",[],"['isocaloric placebo', 'Daily Protein-Polyphenol Ingestion', 'resistance-type exercise training (RET']","['Daily Myofibrillar Protein Synthesis Rates and Promotes Early Muscle Functional Gains', 'gain in quadriceps muscle volume', 'muscle function and potentiate quadriceps volume and muscle fiber cross-sectional area (fCSA', 'PPB increased 48 h MyoPS rates', 'peak isometric torque, muscle function or MyoPS', 'daily myofibrillar protein synthesis (MyoPS) rates', 'isokinetic muscle function']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",,0.012653,"Additionally, PPB increased isokinetic muscle function over 10 sessions of training relative to the untrained control leg (%U) from 99.9 ± 1.8 pre-training to 107.2 ± 2.4 %U at session 10 (versus 102.6 ± 3.9 to 100.8 ± 2.4 %U at session 10 in PLA; interaction P<0.05).","[{'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Pavis', 'Affiliation': 'Nutritional Physiology Research Group, Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Tom S O', 'Initials': 'TSO', 'LastName': 'Jameson', 'Affiliation': 'Nutritional Physiology Research Group, Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Blackwell', 'Affiliation': 'Nutritional Physiology Research Group, Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fulford', 'Affiliation': 'Institute of Biomedical and Clinical Sciences, University of Exeter Medical School, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Doaa R', 'Initials': 'DR', 'LastName': 'Abdelrahman', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Murton', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Alamdari', 'Affiliation': 'Beachbody LLC, Santa Monica, California.'}, {'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Mikus', 'Affiliation': 'Beachbody LLC, Santa Monica, California.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Wall', 'Affiliation': 'Nutritional Physiology Research Group, Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Francis B', 'Initials': 'FB', 'LastName': 'Stephens', 'Affiliation': 'Nutritional Physiology Research Group, Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, United Kingdom.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00328.2021']
3537,35042047,Intrapartum nipple stimulation therapy for labor induction: a randomized controlled external pilot study of acceptability and feasibility.,"BACKGROUND


Nipple stimulation is purported as a natural and inexpensive method for inducing labor, but its use is understudied.
OBJECTIVE


We aimed to assess whether conducting a large randomized controlled trial comparing intrapartum nipple stimulation therapy with oxytocin infusion is feasible and acceptable to patients and obstetrical care providers.
STUDY DESIGN


This single-center parallel-group randomized controlled external pilot study (ClinicalTrials.gov Identifier NCT04756089) included women at ≥36 weeks of gestation who were planned to receive exogenous oxytocin for their labor induction. Women who were <18 years old, non-English speaking, or with fetuses at increased risk of neonatal intensive care were excluded. Stratified by parity, women were randomized 3:1 to intrapartum nipple stimulation therapy or immediate receipt of oxytocin. Women assigned to nipple stimulation therapy were asked to stimulate with an electric breast pump or by hand for periods of at least 30 minutes, with breaks as needed for up to 15 minutes at a time, for at least a cumulative 2 hours before considering initiation of oxytocin, and to complete intrapartum diaries. Labor characteristics and outcomes were examined. Validated questionnaires were used to assess the participants' pain level during the intervention, their sense of control during childbirth, and their breastfeeding success. Primary outcome measures were recruitment, adherence to study protocol and follow-up, and crossover rates.
RESULTS


A total of 620 women underwent labor induction from March 13, 2021 to June 23, 2021. Of 557 potentially eligible women, 53 were approached by available research staff. Of the 53 women, 24 (45%) consented and enrolled: 18 randomized to nipple stimulation and 6 randomized to oxytocin. Moreover, 1 woman assigned to nipple stimulation withdrew because of delay of clinical care and received oxytocin (crossover rate of 1/24 [4%]), and 1 woman assigned to oxytocin did not receive it because of spontaneous labor progress. All other participants followed their assigned intervention. The 17 women who performed nipple stimulation stimulated for a median duration of 198 (interquartile range, 125-291) minutes and required a median of 69 (interquartile range, 21-80) minutes of stimulation before achieving at least 3 contractions in a 10-minute window, averaged >30 minutes (also known as ""adequate"" contractions). Among those assigned to nipple stimulation therapy, 15 of 17 women (88%) later received oxytocin infusion before delivery. The median times from intervention start to delivery were 16.4 (interquartile range, 0.6-28.2) hours for women assigned to nipple stimulation and 20.6 (interquartile range, 14.2-23.4) hours for women assigned to oxytocin infusion. Of note, 12 women (50%) completed their postpartum study questionnaires.
CONCLUSION


Random assignment to either intrapartum nipple stimulation therapy or oxytocin infusion for labor induction was feasible and acceptable to patients and obstetrical care providers.",2022,"Among those assigned to nipple stimulation therapy, 15/17 (88%) later received oxytocin infusion prior to delivery.","['Those <18 years old, non-English-speaking, or with fetuses at increased risk for neonatal intensive care were excluded', 'Of 557 potentially eligible women, 53 were approached by available research staff', 'women with gestations ≥36 weeks who were planned to receive', '12 (50%) women completed their postpartum study questionnaires', '17 women who performed nipple stimulation stimulated for a median duration of 198 (IQR 125-291) minutes and required a median of 69', 'patients and obstetric care providers', 'labor induction', '620 women underwent labor induction from 3/13/21-6/23/21', '24 (45%) consented and enrolled: 18 randomized to']","['Intrapartum nipple stimulation therapy', 'nipple stimulation therapy versus oxytocin', 'intrapartum nipple stimulation therapy or immediate receipt of oxytocin', 'oxytocin', 'nipple stimulation therapy', 'intrapartum nipple stimulation therapy versus oxytocin infusion', 'nipple stimulation', 'exogenous oxytocin']","['recruitment, adherence to study protocol and follow-up, and cross-over rates', 'median time from intervention start to delivery', 'pain level']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021711', 'cui_str': 'Neonatal Intensive Care'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205101', 'cui_str': 'External'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",620.0,0.155826,"Among those assigned to nipple stimulation therapy, 15/17 (88%) later received oxytocin infusion prior to delivery.","[{'ForeName': 'Elisabeth L', 'Initials': 'EL', 'LastName': 'Stark', 'Affiliation': 'From the Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale New Haven Hospital, New Haven, CT (Drs Stark and Athens). Electronic address: elisabeth.stark@yale.edu.'}, {'ForeName': 'Zoe G', 'Initials': 'ZG', 'LastName': 'Athens', 'Affiliation': 'From the Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale New Haven Hospital, New Haven, CT (Drs Stark and Athens).'}, {'ForeName': 'Moeun', 'Initials': 'M', 'LastName': 'Son', 'Affiliation': 'and Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale School of Medicine, New Haven, CT (Dr Son).'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100575']
3538,35043507,"Topically administered purified clinoptilolite-tuff for the treatment of cutaneous wounds: A prospective, randomised phase I clinical trial.","In an ageing society, chronic ulcers pose an increasingly relevant healthcare issue associated with significant morbidity and an increasing financial burden. Hence, there is an unmet medical need for novel, cost-effective therapies that improve healing of chronic cutaneous wounds. This prospective, randomised, open-label, phase I trial investigated the safety and tolerability of topically administered purified clinoptilolite-tuff (PCT), mainly consisting of the naturally occurring zeolite-mineral clinoptilolite, in artificial wounds in healthy male volunteers compared to the standard of care (SoC). We found that topically administered PCT was safe for therapeutic application in acute wounds in healthy male volunteers. No significant differences in wound healing or wound conditions were observed compared to SoC-treated wounds. However, we found a significantly higher proportion of CD68-positive cells and a significantly lower proportion of α-smooth muscle actin-positive cells in PCT-treated wounds. Scanning electron microscopy revealed PCT particles in the restored dermis in some cases. However, these did not impede wound healing or clinical symptoms. Hence, purified PCT could represent an attractive, cost-effective wound treatment promoting the process of healing.",2022,No significant differences in wound healing or wound conditions were observed compared to SoC-treated wounds.,"['healthy male volunteers', 'cutaneous wounds']","['Topically administered purified clinoptilolite-tuff', 'purified clinoptilolite-tuff (PCT), mainly consisting of the naturally occurring zeolite-mineral clinoptilolite', 'PCT']","['safety and tolerability', 'wound healing or wound conditions', 'wound healing or clinical symptoms', 'α-smooth muscle actin-positive cells', 'proportion of CD68-positive cells']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0661172', 'cui_str': 'clinoptilolite'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0078755', 'cui_str': 'Zeolite'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1267092', 'cui_str': 'Smooth muscle (tissue)'}, {'cui': 'C0001271', 'cui_str': 'Actin'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}]",,0.00965604,No significant differences in wound healing or wound conditions were observed compared to SoC-treated wounds.,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Deinsberger', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Marquart', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Nizet', 'Affiliation': 'Glock Health, Science and Research GmbH, Deutsch-Wagram, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Meisslitzer', 'Affiliation': 'Glock Health, Science and Research GmbH, Deutsch-Wagram, Austria.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Tschegg', 'Affiliation': 'Glock Health, Science and Research GmbH, Deutsch-Wagram, Austria.'}, {'ForeName': 'Kateryna', 'Initials': 'K', 'LastName': 'Uspenska', 'Affiliation': 'Gouya-Insights, Vienna, Austria.'}, {'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Gouya', 'Affiliation': 'Gouya-Insights, Vienna, Austria.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Niederdöckl', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Freissmuth', 'Affiliation': 'Center for Physiology and Pharmacology, Institute of Pharmacology, Gaston H. Glock Laboratories for Exploratory Drug Research, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wolzt', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Weber', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12991']
3539,34965945,Updated Overall Survival of Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone in Pre- and Perimenopausal Patients with HR+/HER2- Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical Trial.,"PURPOSE


Ribociclib plus endocrine therapy (ET) demonstrated a statistically significant progression-free survival and overall survival (OS) benefit in the phase III MONALEESA-7 trial of pre-/perimenopausal patients with hormone receptor (HR)-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC). The median OS was not reached in the ribociclib arm in the protocol-specified final analysis; we hence performed an exploratory OS and additional outcomes analysis with an extended follow-up (median, 53.5 months).
PATIENTS AND METHODS


Patients were randomized to receive ET [goserelin plus nonsteroidal aromatase inhibitor (NSAI) or tamoxifen] with ribociclib or placebo. OS was evaluated with a stratified Cox proportional hazard model and summarized with Kaplan-Meier methods.
RESULTS


The intent-to-treat population included 672 patients. Median OS was 58.7 months with ribociclib versus 48.0 months with placebo [hazard ratio = 0.76; 95% confidence interval (CI), 0.61-0.96]. Kaplan-Meier estimated OS at 48 months was 60% and 50% with ribociclib and placebo, respectively. Subgroup analyses were generally consistent with the OS benefit, including patients who received NSAI and patients aged less than 40 years. Subsequent antineoplastic therapies following discontinuation were balanced between the ribociclib (77%) and placebo (78%) groups. Use of cyclin-dependent kinase 4/6 inhibitors after discontinuation was higher with placebo (26%) versus ribociclib (13%). Time to first chemotherapy was significantly delayed with ribociclib versus placebo. No drug-drug interactions were observed between ribociclib and either NSAI.
CONCLUSIONS


Ribociclib plus ET continued to show significantly longer OS than ET alone in pre-/perimenopausal patients, including patients aged less than 40 years, with HR+/HER2- ABC with 53.5 months of median follow-up (ClinicalTrials.gov, NCT02278120).",2022,Use of cyclin-dependent kinase 4/6 inhibitors after discontinuation was higher with placebo (26%) versus ribociclib (13%).,"['672 patients', 'pre-/perimenopausal patients with hormone receptor (HR)-positive (HR + ), HER2-negative (HER2 - ) advanced breast cancer (ABC', 'Pre- and Perimenopausal Patients with HR + /HER2 -  Advanced Breast Cancer in MONALEESA-7', 'Patients']","['placebo', 'ribociclib and placebo', 'ribociclib versus placebo', 'Ribociclib plus endocrine therapy (ET', 'ribociclib or placebo', 'Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone', 'NSAI', 'ET [goserelin plus nonsteroidal aromatase inhibitor (NSAI) or tamoxifen']","['progression-free survival and overall survival (OS) benefit', 'median OS', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",672.0,0.357238,Use of cyclin-dependent kinase 4/6 inhibitors after discontinuation was higher with placebo (26%) versus ribociclib (13%).,"[{'ForeName': 'Yen-Shen', 'Initials': 'YS', 'LastName': 'Lu', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Division of Medical Senology, European Institute of Oncology (IEO), IRCCS, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Franke', 'Affiliation': 'Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Bardia', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': 'Breast Unit, Champalimaud Foundation/Clinical Center, Lisbon, Portugal.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hurvitz', 'Affiliation': 'UCLA Jonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Chow', 'Affiliation': 'Organisation for Oncology and Translational Research, Hong Kong.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Severance Hospital of Yonsei University Health System, Seoul, Republic of Korea.'}, {'ForeName': 'Keun Seok', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Campos-Gomez', 'Affiliation': 'Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Villanueva Vazquez', 'Affiliation': ""Institut Català d'Oncologia, Hospital Moisès Broggi, Barcelona, Spain.""}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'K Govind', 'Initials': 'KG', 'LastName': 'Babu', 'Affiliation': 'HCG Curie Centre of Oncology and Kidwai Memorial Institute of Oncology, Bangalore, India.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Wheatley-Price', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Michelino', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'Young-Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kuemmel', 'Affiliation': 'Breast Unit, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Nagi', 'Initials': 'N', 'LastName': 'El-Saghir', 'Affiliation': 'American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': ""O'Regan"", 'Affiliation': 'Carbone Cancer Center, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Gasch', 'Affiliation': 'Novartis Ireland Limited, Dublin, Ireland.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Solovieff', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Yongyu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Arunava', 'Initials': 'A', 'LastName': 'Chakravartty', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Debu', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-3032']
3540,35044841,"Examining Audiology Students' Clinical Collaboration Skills When Using Virtual Audiology Cases Aided With No Collaboration, Live Collaboration, and Virtual Collaboration.","INTRODUCTION


The purpose of this study was to examine students' ability to use effective clinical collaboration online in a designed scaffolded environment. Three groups were formed to achieve this goal: two control groups (one using no collaboration and one using live, face-to-face collaboration) and one treatment group using virtual collaboration.
METHOD


A quasi-experimental design was conducted at two U.S. universities to examine whether there is a significant difference in clinical reasoning skills between three treatment groups using IUP Audiosim software. Two computer-based audiology case simulations were developed, and participants were randomly placed into the three groups. The clinical reasoning data were analyzed using one-way analysis of variance and Tukey's post hoc analyses.
RESULTS


The results indicated that there was a significant difference in clinical reasoning skills between the three treatment groups. The score obtained by the no-collaboration group was significantly less than the scores obtained by the virtual and live collaboration groups.
CONCLUSIONS


The results imply that lower scores were associated with students receiving more instructor-designed content and higher scores with students receiving less instructor-designed content. Students who received more scaffolds with the collaborations may have demonstrated better decision-making outside the training exercise than those who did not receive scaffolds. However, lower scores on the exercise did not necessarily imply lower skill. Lower scores simply implied a different path toward mastery.",2022,"The score obtained by the no-collaboration group was significantly less than the scores obtained by the virtual and live collaboration groups.
",[],"['control groups (one using no collaboration and one using live, face-to-face collaboration) and one treatment group using virtual collaboration']",['clinical reasoning skills'],[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}]",,0.0297236,"The score obtained by the no-collaboration group was significantly less than the scores obtained by the virtual and live collaboration groups.
","[{'ForeName': 'Ramy', 'Initials': 'R', 'LastName': 'Shaaban', 'Affiliation': 'Department of Instructional Technology and Learning Sciences, Utah State University, Logan.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Richburg', 'Affiliation': 'Department of Communication Sciences and Disorders, Wichita State University, KS.'}]",American journal of audiology,['10.1044/2021_AJA-21-00052']
3541,35042101,Cost of Hepatitis C care facilitation for HIV/Hepatitis C Co-infected people who use drugs.,"BACKGROUND


Using data from a randomized trial, we evaluated the cost of HCV care facilitation that supports moving along the continuum of care for HIV/HCV co-infected individuals with substance use disorder.
METHODS


Participants were HIV patients residing in the community, initially recruited from eight US hospital sites. They received HCV care facilitation (n = 51) or treatment as usual (n = 62) for up to six months. We used micro-costing methods to evaluate costs from the healthcare sector and patient perspectives in 2017 USD. We conducted sensitivity analyses varying care facilitator caseloads and examined offsetting savings using participant self-reported healthcare utilization.
RESULTS


The average site start-up cost was $6320 (site range: $4320-$7000), primarily consisting of training. The mean weekly cost per participant was $20 (site range: $4-$30) for care facilitation visits and contacts, $360 (site range: $130- $700) for supervision and client outreach, and $70 (site range: $20-$180) for overhead. In sensitivity analyses applying a weekly caseload of 10 participants per care facilitator (versus 1-6 observed in the trial), the total mean weekly care facilitation cost from the healthcare sector perspective decreased to $110. Weekly participant time and travel costs averaged $7. There were no significant differences in other healthcare service costs between participants in the intervention and control arms.
CONCLUSION


Weekly HCV care facilitation costs were approximately $450 per participant, but approximately $110 at a real-world setting maximum caseload of 10 participants per week. No healthcare cost offsets were identified during the trial period, although future savings might result from successful HCV treatment.",2022,"The mean weekly cost per participant was $20 (site range: $4-$30) for care facilitation visits and contacts, $360","['Participants were HIV patients residing in the community, initially recruited from eight US hospital sites', '2017 USD', 'HIV/Hepatitis C Co-infected people who use drugs']","['Hepatitis C care facilitation', 'HCV care facilitation']","['healthcare service costs', 'average site start-up cost', 'Weekly participant time and travel costs']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}]","[{'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}]","[{'cui': 'C0557829', 'cui_str': 'Healthcare services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040802', 'cui_str': 'Travel'}]",,0.0558162,"The mean weekly cost per participant was $20 (site range: $4-$30) for care facilitation visits and contacts, $360","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gutkind', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, 425 E 61st St, New York, NY 10065, USA. Electronic address: sg3787@cumc.columbia.edu.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Starbird', 'Affiliation': 'Columbia University School of Nursing, 560 West 168th St, New York, NY 10032, USA. Electronic address: starbird@nursing.upenn.edu.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, 425 E 61st St, New York, NY 10065, USA. Electronic address: smm2010@med.cornell.edu.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Teixeira', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, 425 E 61st St, New York, NY 10065, USA. Electronic address: pault212@gmail.com.'}, {'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Gooden', 'Affiliation': 'Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, 722 W 168th St, New York, NY 10032, USA. Electronic address: lkg2129@columbia.edu.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Matheson', 'Affiliation': 'San Francisco Department of Health, 101 Grove St, San Francisco, CA 94102, USA. Electronic address: tim.matheson@sfdph.org.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'Department of Epidemiology and Public Health, University of Miami School of Medicine, 1120 NW 14th St Miami, FL 33136, USA. Electronic address: DFeaster@biostat.med.miami.edu.'}, {'ForeName': 'Mamta K', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA. Electronic address: Mamta.Jain@UTSouthwestern.edu.'}, {'ForeName': 'Carmen L', 'Initials': 'CL', 'LastName': 'Masson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California San Francisco, 401 Parnassus Ave, San Francisco, CA 94143, USA. Electronic address: Carmen.Masson@ucsf.edu.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Perlman', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, NY 10029, USA. Electronic address: David.Perlman@mountsinai.org.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Del Rio', 'Affiliation': 'Department of Global Health, Rollins School of Public Health at Emory University, 1518 Clifton Rd NE, Atlanta, GA 30322, USA. Electronic address: cdelrio@emory.edu.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': 'Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, 722 W 168th St, New York, NY 10032, USA. Electronic address: lm2892@columbia.edu.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, 425 E 61st St, New York, NY 10065, USA. Electronic address: brs2006@med.cornell.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2022.109265']
3542,35061235,"Bioequivalence and Safety Assessment of Two Formulations of Metformin Hydrochloride Sustained-Release Tablets (Yuantang ®  SR and Glucophage ®  XR) Under Fed Conditions in Healthy Chinese Adult Subjects: An Open-Label, Two-Way Crossover, Sequence Randomized Phase I Clinical Trial.","OBJECTIVE


The purpose of this single-center, randomized, open, two-period, two-sequence crossover, single-dose administration, bioequivalence research was to evaluate the bioequivalence and safety of the generic formulations of metformin hydrochloride sustained-release (MH-SR) 500 mg tablets (test preparation [T]: Yuantang ®  SR) and the original formulation (reference preparation [R]: Glucophage ®  XR) in 36 healthy Chinese volunteers under postprandial conditions.
METHODS


Subjects received 500 mg T/R in each period, with a 7-day washout period. Venous blood samples of 4 mL each were collected from each subject 19 times spanning predose (0 h) to 36 h postdose. The metformin concentration in deproteinized plasma was determined by high-performance liquid chromatography-tandem mass spectrometry. Bioequivalence (80.00-125.00%) was assessed by adjusted geometric mean ratios (GMRs) and two-sided 90% confidence intervals (CIs) of the area under the curve (AUC) and maximum concentration (C max ) for each component. SAS 9.4 software was used for statistical analysis and Phoenix WinNonlin software v7 was used to analyze the pharmacokinetic parameters.
RESULTS


Thirty-four volunteers completed the clinical study. The 90% CIs (96.12-105.44% for AUC from time zero to the time of the last measurable concentration [AUC t ], 96.22-105.54% for AUC extrapolated from time zero to infinity [AUC ∞ ], and 98.42-105.00% for C max ) of T/R adjusted GMRs were within the bioequivalence acceptance range of 80.00-125.00%, indicating that they are bioequivalent. No serious adverse events occurred in this study, indicating that the two formulations were effective and well tolerated.
CONCLUSIONS


Yuantang ®  SR was confirmed to be a well tolerated and bioequivalent alternative to Glucophage ®  XR when taken under postprandial conditions in healthy Chinese volunteers. The Clinical Trials Registry Platform used for this study was http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml . The trial registration numbers (TRNs) and dates of registrations were CTR20180476 (19 April 2018) for this clinical trial and CTR20171595 (11 January 2018) for the pilot trial.",2022,Bioequivalence (80.00-125.00%) was assessed by adjusted geometric mean ratios (GMRs) and two-sided 90% confidence intervals (CIs) of the area under the curve (AUC) and maximum concentration (C max ) for each component.,"['Thirty-four volunteers completed the clinical study', 'Healthy Chinese Adult Subjects', 'healthy Chinese volunteers', '36 healthy Chinese volunteers under postprandial conditions']","['metformin hydrochloride sustained-release (MH-SR) 500 mg tablets (test preparation [T', 'original formulation (reference preparation [R]: Glucophage ®  XR', 'Yuantang ®  SR', 'Metformin Hydrochloride Sustained-Release Tablets (Yuantang ®  SR and Glucophage ®  XR']","['effective and well tolerated', 'adjusted geometric mean ratios (GMRs) and two-sided 90% confidence intervals (CIs) of the area under the curve (AUC) and maximum concentration (C max ', 'serious adverse events']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0770893', 'cui_str': 'Metformin hydrochloride'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C2936315', 'cui_str': 'Test Preparation'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0591573', 'cui_str': 'Glucophage'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",36.0,0.0266948,Bioequivalence (80.00-125.00%) was assessed by adjusted geometric mean ratios (GMRs) and two-sided 90% confidence intervals (CIs) of the area under the curve (AUC) and maximum concentration (C max ) for each component.,"[{'ForeName': 'Ming-Li', 'Initials': 'ML', 'LastName': 'Sun', 'Affiliation': ""Phase I Clinical Trial Center, Beijing Shijitan Hospital Affiliated to Capital Medical University, 10 Tieyi Road, Yangfangdian, Haidian District, Beijing, 100038, People's Republic of China.""}, {'ForeName': 'Hui-Juan', 'Initials': 'HJ', 'LastName': 'Liu', 'Affiliation': ""Phase I Clinical Trial Center, Beijing Shijitan Hospital Affiliated to Capital Medical University, 10 Tieyi Road, Yangfangdian, Haidian District, Beijing, 100038, People's Republic of China.""}, {'ForeName': 'Xiang-Dong', 'Initials': 'XD', 'LastName': 'Luo', 'Affiliation': ""Department of Research and Development, Guangdong Sinocorp Pharmaceutical Co., Ltd, Xiang-er Road, Huizhou Industrial Transfer Park, Longmen County, Huizhou, Guangdong Province, 516800, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Phase I Clinical Trial Center, Beijing Shijitan Hospital Affiliated to Capital Medical University, 10 Tieyi Road, Yangfangdian, Haidian District, Beijing, 100038, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Phase I Clinical Trial Center, Beijing Shijitan Hospital Affiliated to Capital Medical University, 10 Tieyi Road, Yangfangdian, Haidian District, Beijing, 100038, People's Republic of China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Phase I Clinical Trial Center, Beijing Shijitan Hospital Affiliated to Capital Medical University, 10 Tieyi Road, Yangfangdian, Haidian District, Beijing, 100038, People's Republic of China.""}, {'ForeName': 'Xinghe', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Phase I Clinical Trial Center, Beijing Shijitan Hospital Affiliated to Capital Medical University, 10 Tieyi Road, Yangfangdian, Haidian District, Beijing, 100038, People's Republic of China. wangxh@bjsjth.cn.""}]",Drugs in R&D,['10.1007/s40268-021-00377-w']
3543,35055577,Effectiveness of a Mindfulness-Based Group Intervention for Chinese University Students with Sleep Problems.,"The increasing prevalence of sleep disorders among university students should be taken seriously. Group counseling involving a mindfulness-based strategy may help prevent students from developing insomnia and subsequent mental health disorders. This study aimed to evaluate the ameliorating effects of a mindfulness-based group intervention on sleep problems and emotional symptoms in university students in China. Twenty-one university students (16 females, 22.71 ± 4.28 years) who were not on medication were recruited and assigned to the intervention group based on the criterion of high levels of sleep problems. Additionally, twenty-four university students (19 females, 24.50 ± 0.93 years) were included as a nonrandomized control group. Individuals in the intervention group participated in a two-hour group intervention once a week for eight sessions. All participants completed self-reported questionnaire baseline tests, postintervention tests, and one-month follow-ups on mindfulness, sleep quality, anxiety and depressive symptoms. Repeated-measures ANOVA was performed. The results revealed significant intervention effects, with significant differences observed between the two groups in mindfulness and sleep quality. However, there was no significant effect of the intervention on anxiety and depressive symptoms. This study contributes to a better understanding of the effectiveness of mindfulness-based intervention in addressing sleep problems in university students.",2022,This study contributes to a better understanding of the effectiveness of mindfulness-based intervention in addressing sleep problems in university students.,"['Twenty-one university students (16 females, 22.71 ± 4.28 years) who were not on medication', 'university students in China', 'students from developing insomnia and subsequent mental health disorders', 'twenty-four university students (19 females, 24.50 ± 0.93 years', 'Chinese University Students with Sleep Problems', 'university students']","['mindfulness-based intervention', 'mindfulness-based group intervention', 'Mindfulness-Based Group Intervention']","['sleep problems and emotional symptoms', 'mindfulness, sleep quality, anxiety and depressive symptoms', 'anxiety and depressive symptoms', 'mindfulness and sleep quality']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C4517486', 'cui_str': '0.93'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.00668005,This study contributes to a better understanding of the effectiveness of mindfulness-based intervention in addressing sleep problems in university students.,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Fu', 'Affiliation': 'Faculty of Humanities and Social Sciences, Beijing University of Technology, Beijing 100124, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'Faculty of Humanities and Social Sciences, Beijing University of Technology, Beijing 100124, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Beijing Institute of Education, Beijing 100097, China.'}, {'ForeName': 'Xueqi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Faculty of Humanities and Social Sciences, Beijing University of Technology, Beijing 100124, China.'}, {'ForeName': 'Yueyue', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'School of Psychology, Henan University, Kaifeng 475004, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Faculty of Humanities and Social Sciences, Beijing University of Technology, Beijing 100124, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Psychology, University of Alberta, Edmonton, AB T6G 2E9, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph19020755']
3544,35050796,Six weeks of static apnea training does not affect Hbmass and exercise performance.,"Acute apnea is known to induce decreases in oxyhemoglobin desaturation (SpO 2 ) and increases in erythropoietin concentration ([EPO]). This study examined the potential of an apnea training program to induce erythropoiesis and increase hematological parameters and exercise performance. Twenty-two male subjects were randomly divided into an apnea and control group. The apnea group performed a 6-wk apnea training program consisting of a daily series of five maximal static apneas. Before and after training, subjects visited the lab on 3 test days to perform  1 ) a ramp incremental test measuring V̇o 2peak ,  2 ) CO-rebreathing for Hbmass determination and a 3-km time trial, and  3 ) an apnea test protocol with continuous finger SpO 2  registration. Venous blood samples were drawn before and 180 min after the apnea test for analysis of [EPO]. Minimal SpO 2  reached during the apnea test protocol was 91 ± 7% pre and 82 ± 7% post apnea training. The apnea test protocol did not elicit an acute increase in [EPO] ( P  = 0.685) before nor after the training program. Consequently, resting [EPO] ( P  = 0.170), Hbmass ( P  = 0.134), V̇o 2peak  ( P  = 0.796), and 3-km cycling time trial performance ( P  = 0.509) were not affected either. The apnea test and training protocol, consisting of five maximal static apneas, did not induce a sufficiently strong hypoxic stimulus to cause erythropoiesis and therefore did not result in an increase in resting [EPO], Hbmass, V̇o 2peak , or time trial performance. Longer and/or more intense training sessions inducing a stronger hypoxic stimulus are probably needed to obtain changes in hematological and exercise parameters. NEW & NOTEWORTHY  Apnea training has been suggested as a promising method to improve exercise performance for over a decade. However, to our knowledge, this study is the first to evaluate its value on both hematological parameters and exercise performance, including Hbmass and a control group. No changes in Hbmass nor exercise performance were observed. Contradicting previous research, no acute increase in [EPO] following apnea was observed either, indicating that more intense protocols are needed, at least in nonapnea-trained individuals.",2022,The apnea test protocol did not elicit an acute increase in [EPO] (p=0.685) before nor after the training program.,['Twenty-two male subjects'],"['apnea training program consisting of a daily series of 5 maximal static apneas', 'static apnea training', 'ramp incremental test measuring V̇O 2peak , 2) CO-rebreathing for Hb mass determination and a 3-km time trial and 3) an apnea test protocol with continuous finger SpO 2  registration', 'apnea training program']","['oxyhemoglobin desaturation', 'Venous blood samples', 'resting [EPO], Hbmass, V̇O 2peak  or time trial performance', 'acute increase in [EPO', 'resting [EPO', 'erythropoietin concentration ([EPO', 'V̇O 2peak  (p=0.796) and 3-km cycling time trial performance', 'Hbmass and exercise performance']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1096023', 'cui_str': 'Apnoea test'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}]","[{'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",22.0,0.00748536,The apnea test protocol did not elicit an acute increase in [EPO] (p=0.685) before nor after the training program.,"[{'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Bouten', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Debusschere', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Lootens', 'Affiliation': 'Doping Control Laboratory, Department of Diagnostic Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Declercq', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Eenoo', 'Affiliation': 'Doping Control Laboratory, Department of Diagnostic Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Boone', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Bourgois', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00770.2021']
3545,35055535,Electroneurographic Evaluation of Neural Impulse Transmission in Patients after Ischemic Stroke Following Functional Electrical Stimulation of Antagonistic Muscles at Wrist and Ankle in Two-Month Follow-Up.,"The available data from electroneurography (ENG) studies on the transmission of neural impulses in the motor fibers of upper and lower extremity nerves following neuromuscular functional electrical stimulation (NMFES) combined with kinesiotherapy in post-stroke patients during sixty-day observation do not provide convincing results. This study aims to compare the effectiveness of an NMFES of antagonistic muscle groups at the wrist and ankle and kinesiotherapy based mainly on proprioceptive neuromuscular facilitation (PNF). An ENG was performed once in a group of 60 healthy volunteers and three times in 120 patients after stroke (T0, up to 7 days after the incident; T1, after 21 days of treatment; and T2, after 60 days of treatment); 60 subjects received personalized NMFES and PNF treatment (NMFES+K), while the other 60 received only PNF (K). An ENG studied peripheral (M-wave recordings), C8 and L5 ventral root (F-wave recordings) neural impulse transmission in the peroneal and the ulnar nerves on the hemiparetic side. Both groups statistically differed in their amplitudes of M-wave recording parameters after peroneal nerve stimulation performed at T0 and T2 compared with the control group. After 60 days of treatment, only the patients from the NMFES+K group showed significant improvement in M-wave recordings. The application of the proposed NMFES electrostimulation algorithm combined with PNF improved the peripheral neural transmission in peroneal but not ulnar motor nerve fibers in patients after ischemic stroke. Combined kinesiotherapy and safe, personalized, controlled electrotherapy after stroke give better results than kinesiotherapy alone.",2022,Both groups statistically differed in their amplitudes of M-wave recording parameters after peroneal nerve stimulation performed at T0 and T2 compared with the control group.,"['60 healthy volunteers', 'Patients after Ischemic Stroke Following Functional Electrical Stimulation of Antagonistic Muscles at Wrist and Ankle in Two-Month Follow-Up']","['Electroneurographic Evaluation of Neural Impulse Transmission', 'personalized NMFES and PNF treatment (NMFES+K), while the other 60 received only PNF (K', 'NMFES+K', 'NMFES electrostimulation algorithm combined with PNF', 'neuromuscular functional electrical stimulation (NMFES) combined with kinesiotherapy']",['peripheral neural transmission'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1096702', 'cui_str': 'Kinesitherapy'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0027793', 'cui_str': 'Synaptic transmission'}]",60.0,0.0159611,Both groups statistically differed in their amplitudes of M-wave recording parameters after peroneal nerve stimulation performed at T0 and T2 compared with the control group.,"[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Kaczmarek', 'Affiliation': 'Neurology Ward, Pomeranian District Hospital, Chałubińskiego No. 7, 75-581 Koszalin, Poland.'}, {'ForeName': 'Juliusz', 'Initials': 'J', 'LastName': 'Huber', 'Affiliation': 'Department of Pathophysiology of Locomotor Organs, University of Medical Sciences, 28 Czerwca 1956 No. 135/137, 60-545 Poznań, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Leszczyńska', 'Affiliation': 'Department of Pathophysiology of Locomotor Organs, University of Medical Sciences, 28 Czerwca 1956 No. 135/137, 60-545 Poznań, Poland.'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Daroszewski', 'Affiliation': 'Department of Organization and Management in Health Care, University of Medical Sciences, 28 Czerwca 1956 No. 135/137, 60-545 Poznań, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph19020713']
3546,35055470,A Group Intervention to Promote Resilience in Nursing Professionals: A Randomised Controlled Trial.,"In this study, a new group intervention program to foster resilience in nursing professionals was tested for efficacy. In total, 72 nurses were recruited and randomised to either an intervention condition or to a wait list control condition. The study had a pre-test, post-test, follow-up design. The eight-week program targeted six resilience factors: cognitive flexibility, coping, self-efficacy, self-esteem, self-care, and mindfulness. Compared to the control group, the intervention group reported a significant improvement in the primary outcome mental health (measured with the General Health Questionnaire) from pre-test ( M  = 20.79;  SD  = 9.85) to post-test ( M  = 15.81;  SD  = 7.13) with an estimated medium effect size ( p  = 0.03,  η 2  = 0.08) at post-test. Further significant improvements were found for resilience and other resilience related outcomes measures. The individual stressor load of the subjects was queried retrospectively in each measurement. Stress levels had a significant influence on mental health. The intervention effect was evident even though the stress level in both groups did not change significantly between the measurements. Follow-up data suggest that the effects were sustained for up to six months after intervention. The resilience intervention reduced mental burden in nurses and also positively affected several additional psychological outcomes.",2022,"The eight-week program targeted six resilience factors: cognitive flexibility, coping, self-efficacy, self-esteem, self-care, and mindfulness.","['72 nurses', 'Nursing Professionals']",['intervention condition or to a wait list control condition'],"['primary outcome mental health', 'stress level', 'General Health Questionnaire', 'mental health']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}]",72.0,0.014188,"The eight-week program targeted six resilience factors: cognitive flexibility, coping, self-efficacy, self-esteem, self-care, and mindfulness.","[{'ForeName': 'Gesche', 'Initials': 'G', 'LastName': 'Janzarik', 'Affiliation': 'Leibniz Institute for Resilience Research (LIR) Mainz, 55122 Mainz, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wollschläger', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center of the Johannes Gutenberg University Mainz, 55131 Mainz, Germany.'}, {'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Wessa', 'Affiliation': 'Leibniz Institute for Resilience Research (LIR) Mainz, 55122 Mainz, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Lieb', 'Affiliation': 'Leibniz Institute for Resilience Research (LIR) Mainz, 55122 Mainz, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph19020649']
3547,35020023,"Local administration of epsilon-aminocaproic acid reduces post-operative blood loss from surgery for closed, Sanders III-IV calcaneal fractures.","PURPOSE


To investigate whether local administration of epsilon-aminocaproic acid (EACA) is effective and safe in reducing the post-operative blood loss in surgery for Sanders III-IV calcaneal fractures.
METHODS


Patients with Sanders III-IV calcaneal fractures who were hospitalized in our hospital from January 2016 to February 2021 and underwent open reduction internal fixation (ORIF) via lateral approach with an L-shaped incision were included in the current study. Eighty five patients were randomly divided into two groups, EACA group (43) and control group (42). Twenty milliliters of 5% EACA solution or normal saline was perfused into the incision of patients in EACA group and control group, respectively. The volume of post-operative drainage was investigated as the primary outcome. Post-operative blood test, coagulation test, and wound complications were analyzed as the secondary outcomes.
RESULTS


The volume of post-operative drainage at 24 and 48 h was 164.8 ± 51.4 ml, 18.9 ± 3.8 ml for patients in EACA group, and 373.0 ± 88.1 ml, 21.2 ± 4.4 ml for patients in the control group, respectively. EACA greatly reduced the post-operative blood loss compared to the control (normal saline). The difference between the two groups was statistically significant. No statistically significant difference was found between EACA group and control group with regard to the pre-operative, baseline characteristics. Post-operative blood test results demonstrated that haemoglobin and hematocrit were significantly higher in EACA compared to those of control group. No significant difference was found between EACA group and control group in terms of the platelet counts, prothrombin time (P.T.), activated partial prothrombin time (APTT), and wound complications.
CONCLUSION


Local administration of EACA is effective in post-operative blood loss reduction in ORIF surgeries for Sanders III-IV types of calcaneal fractures without increasing the incidence of periwound complication.",2022,"No statistically significant difference was found between EACA group and control group with regard to the pre-operative, baseline characteristics.","['surgery for Sanders III-IV calcaneal fractures', 'Eighty five patients', 'surgery for closed, Sanders III-IV calcaneal fractures', 'Patients with Sanders III-IV calcaneal fractures who were hospitalized in our hospital from January 2016 to February 2021 and underwent']","['open reduction internal fixation (ORIF) via lateral approach with an L-shaped incision', 'EACA', 'epsilon-aminocaproic acid (EACA', 'epsilon-aminocaproic acid', 'EACA solution or normal saline']","['haemoglobin and hematocrit', 'platelet counts, prothrombin time (P.T.), activated partial prothrombin time (APTT), and wound complications', 'volume of post-operative drainage', 'post-operative blood loss', 'Post-operative blood test, coagulation test, and wound complications']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C1297885', 'cui_str': 'Open reduction with internal fixation'}, {'cui': 'C0205514', 'cui_str': 'Lateral approach'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0000608', 'cui_str': '6-Aminocaproic Acid'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0853653', 'cui_str': 'Partial prothrombin time'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C1504378', 'cui_str': 'Coagulation test'}]",85.0,0.0575287,"No statistically significant difference was found between EACA group and control group with regard to the pre-operative, baseline characteristics.","[{'ForeName': 'Lang', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': ""Department of Bone and joint surgery, People's Hospital of Leshan, Shizhong District, Leshan, 614000, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Yangbo', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Bone and Joint Surgery, Affiliated Hospital of Southwest Medical University, No 25 Tai Ping Street, Luzhou, 643000, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Yongcai', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Bone and joint surgery, People's Hospital of Leshan, Shizhong District, Leshan, 614000, Sichuan Province, People's Republic of China. 275817565@qq.com.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Bone and joint surgery, People's Hospital of Leshan, Shizhong District, Leshan, 614000, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Department of Bone and joint surgery, People's Hospital of Leshan, Shizhong District, Leshan, 614000, Sichuan Province, People's Republic of China.""}]",International orthopaedics,['10.1007/s00264-021-05268-y']
3548,35027329,Use of the International Consultation on Incontinence Questionnaires Bladder Diary in Men Seeking therapy for Lower Urinary Tract Symptoms.,"BACKGROUND


Completion rates and correspondence to other measures need to be established for the International Consultation on Incontinence Questionnaire (ICIQ) bladder diary (ICIQ-BD) in the assessment of male lower urinary tract symptoms (LUTS).
OBJECTIVE


To evaluate ICIQ-BD completion rates, frequency, volume, and sensation reporting for men.
DESIGN, SETTING, AND PARTICIPANTS


Baseline data from the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) randomised controlled trial evaluating 820 men at 26 UK hospitals, looking at the ICIQ-BD, uroflowmetry, International Prostate Symptom Score, and ICIQ symptom score for male LUTS (ICIQ-MLUTS), were assessed.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The ICIQ-BD, IPSS, ICIQ-MLUTS, and uroflowmetry data at baseline obtained from UPSTREAM were assessed. Correlations were analysed by Pearson's correlation coefficient, and comparison between groups were performed using paired or unpaired t tests or Tukey's test. All statistical tests were two sided and the strength of evidence was presented using p values.
RESULTS AND LIMITATIONS


Of the participants, 25.0% (205/820) provided complete voiding and bedtime information for 3 d, 41.2% (338/820) omitted bedtime information, and the remainder omitted some or all voiding information. Median values (minimum - maximum) of 24-h, daytime, and night-time frequencies were 9.7 (3.3-24.0), 7.7 (3.3-22.7), and 1.7 (0.0-5.7), respectively. The mean voided volume per micturition for day and night times were 175.8 ± 74.2 and 264.4 ± 150.7 ml (p < 0.001), respectively. For fully completed diaries, day- and night-time frequency showed a weak-to-moderate correlation with symptom score questionnaires. More severe nocturia was generally reported in symptom scores than in the ICIQ-BD. In patients with high bother for increased daytime frequency (symptom), the mean daytime frequency (ICIQ-BD) was 9.6 ± 3.2 versus 7.6 ± 2.2 for low bother (p < 0.001). High bother for nocturia showed night-time frequency of 2.3 ± 1.2 versus 1.5 ± 1.1 for low bother (p < 0.001). For fully and partially completed diaries, ICIQ-BD sensation scores correlated weakly with symptom scores. Voided volumes from the bladder diary and uroflowmetry correlated weakly.
CONCLUSIONS


Two-thirds of men (543/820) fully completed voiding information in the ICIQ-BD, but many omitted bedtime information, limiting the ability to quantify nocturia and diagnose nocturnal polyuria.
PATIENT SUMMARY


Most men with urinary symptoms complete a bladder diary fully but may fail to indicate bedtimes. Extra information from a diary helps support symptom questionnaires to explain a patient's urinary habits.",2022,"In patients with high bother for increased daytime frequency (symptom), the mean daytime frequency (ICIQ-BD) was 9.6 ± 3.2 versus 7.6 ± 2.2 for low bother (p < 0.001).","['Men Seeking therapy for Lower Urinary Tract Symptoms', 'men', '820 men at 26 UK hospitals, looking at the ICIQ-BD, uroflowmetry, International Prostate Symptom Score, and ICIQ symptom score for male LUTS (ICIQ-MLUTS), were assessed']",[],"['ICIQ-BD, IPSS, ICIQ-MLUTS, and uroflowmetry data', 'Incontinence Questionnaire (ICIQ) bladder diary (ICIQ-BD', 'mean voided volume per micturition for day and night times', 'ICIQ-BD sensation scores', 'mean daytime frequency (ICIQ-BD', 'Median values (minimum - maximum) of 24-h, daytime, and night-time frequencies', 'Voided volumes', 'Incontinence Questionnaires Bladder Diary', 'complete voiding and bedtime information', 'ICIQ-BD completion rates, frequency, volume, and sensation reporting', 'daytime frequency (symptom', 'severe nocturia']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}]",820.0,0.115215,"In patients with high bother for increased daytime frequency (symptom), the mean daytime frequency (ICIQ-BD) was 9.6 ± 3.2 versus 7.6 ± 2.2 for low bother (p < 0.001).","[{'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Urology, Yokosuka Kyosai Hospital, Yokosuka, Japan; Department of Urology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; Bristol Randomised Trials Collaboration (BRTC), University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; Bristol Randomised Trials Collaboration (BRTC), University of Bristol, Bristol, UK.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Blair', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; Bristol Randomised Trials Collaboration (BRTC), University of Bristol, Bristol, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Cotterill', 'Affiliation': 'School of Health and Social Wellbeing, University of the West of England, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; Bristol Randomised Trials Collaboration (BRTC), University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Drake', 'Affiliation': 'Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Bristol, UK; Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. Electronic address: marcus.drake@bristol.ac.uk.'}]",European urology focus,['10.1016/j.euf.2021.12.009']
3549,34954044,Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis.,"BACKGROUND


In the primary analysis of the HER2CLIMB trial, tucatinib added to trastuzumab and capecitabine significantly improved overall survival (OS) and progression-free survival (PFS) in patients with human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer. We report efficacy and safety outcomes, including the final OS and safety outcomes from follow-up in HER2CLIMB.
PATIENTS AND METHODS


HER2CLIMB is a randomized, double-blind, placebo-controlled trial in patients with locally advanced or metastatic HER2+ breast cancer, including patients with brain metastases. Patients were randomized 2 : 1 to receive tucatinib or placebo, in combination with trastuzumab and capecitabine. After the primary analysis (median follow-up of 14 months), the protocol was amended to allow for unblinding sites to treatment assignment and cross-over from the placebo combination to the tucatinib combination. Protocol prespecified descriptive analyses of OS, PFS (by investigator assessment), and safety were carried out at ∼2 years from the last patient randomized.
RESULTS


Six hundred and twelve patients enrolled in the HER2CLIMB trial. At a median OS follow-up of 29.6 months, median duration of OS was 24.7 months for the tucatinib combination group versus 19.2 months for the placebo combination group [hazard ratio (HR) for death: 0.73, 95% confidence interval (CI): 0.59-0.90, P = 0.004] and OS at 2 years was 51% and 40%, respectively. HRs for OS across prespecified subgroups were consistent with the HR for the overall study population. Median duration of PFS was 7.6 months for the tucatinib combination group versus 4.9 months for the placebo combination group (HR for progression or death: 0.57, 95% CI: 0.47-0.70, P < 0.00001) and PFS at 1 year was 29% and 14%, respectively. The tucatinib combination was well tolerated with a low rate of discontinuation due to adverse events.
CONCLUSIONS


With additional follow-up, the tucatinib combination provided a clinically meaningful survival benefit for patients with HER2+ metastatic breast cancer.",2022,"The tucatinib combination was well tolerated with a low rate of discontinuation due to adverse events.
","['patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB', 'patients with human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer', 'patients with HER2+ metastatic breast cancer', 'patients with locally advanced or metastatic HER2+ breast cancer, including patients with brain metastases', 'Six hundred and twelve patients enrolled in the HER2CLIMB trial']","['placebo', 'tucatinib or placebo, in combination with trastuzumab and capecitabine', 'Tucatinib versus placebo', 'trastuzumab and capecitabine']","['overall survival (OS) and progression-free survival (PFS', 'median duration of OS', 'PFS', 'Median duration of PFS', 'hazard ratio (HR) for death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517834', 'cui_str': '612'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",612.0,0.806189,"The tucatinib combination was well tolerated with a low rate of discontinuation due to adverse events.
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Curigliano', 'Affiliation': 'Istituto Europeo di Oncologia, Milan, IRCCS and University of Milano, Milan, Italy. Electronic address: giuseppe.curigliano@ieo.it.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mueller', 'Affiliation': 'Universitaetsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Borges', 'Affiliation': 'University of Colorado Hospital, Aurora, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hamilton', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology - Nashville, Nashville, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hurvitz', 'Affiliation': 'University of California, Los Angeles/Jonsson Comprehensive Cancer Center, Los Angeles, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Murthy', 'Affiliation': 'MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Okines', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Paplomata', 'Affiliation': 'Carbone Comprehensive Cancer Center, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'Edinburgh Cancer Research Centre, Edinburgh, UK.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': 'UNC Lineberger Comprehensive Cancer Center, Chapel Hill, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer - Vancouver Centre, Vancouver, Canada.'}, {'ForeName': 'G N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Krop', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pegram', 'Affiliation': 'Stanford Cancer Institute, Palo Alto, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Slamon', 'Affiliation': 'University of California, Los Angeles/Jonsson Comprehensive Cancer Center, Los Angeles, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ramos', 'Affiliation': 'Seagen Inc., Bothell, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Seagen Inc., Bothell, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.12.005']
3550,34954090,The effect of photodynamic therapy on postoperative pain in teeth with primary endodontic infection.,"INTRODUCTION


The objective of this study was to investigate the action of photodynamic therapy on pain control after endodontic treatment in asymptomatic teeth with a primary infection, within a single visit.
METHODS


Sixty (60) single-rooted teeth with pulp necrosis and periapical lesions were selected and randomly divided into two (2) groups (n = 30), according to the protocol; a control group (CG) and a group using photodynamic therapy (aPDT). The canals were instrumented with Reciproc files # 25 up to 40 along the entire length of the canal, using 2% chlorhexidine gel as the auxiliary chemical substance, followed by irrigation with sterile saline. aPDT consited of 0.005% methylene blue as photosensitizer, using AsGaAl diode laser, 660 nm wavelength, 100 mW of power and 9 J of energy, using optical fibers with 365 μm in diameter. The canals were filled with Endomethasone N cement.
RESULTS


Pain intensity was assessed at 8, 12, 24, 48, 72 h and 1 week after endodontic treatment using a visual analogue scale. The level of pain was classified as none (0), mild (1-3), moderate (4-7) or severe (8-10). The data were at a significance level of 5%. There was a statistically significant difference (p<0.05) in the periods of 8, 12, 24, 48 and 72 h between the control group and the aPDT group. After 1 week, there was no statistically significant difference.
CONCLUSIONS


It is concluded that photodynamic therapy had a significant effect on decreasing post-endodontic treatment pain in teeth with necrotic pulp and asymptomatic periapical lesions.",2022,It is concluded that photodynamic therapy had a significant effect on decreasing post-endodontic treatment pain in teeth with necrotic pulp and asymptomatic periapical lesions.,"['asymptomatic teeth with a primary infection, within a single visit', 'teeth with primary endodontic infection', 'Sixty (60) single-rooted teeth with pulp necrosis and periapical lesions']","['chlorhexidine gel as the auxiliary chemical substance, followed by irrigation with sterile saline', 'control group (CG) and a group using photodynamic therapy (aPDT', 'Endomethasone N cement', 'photodynamic therapy']","['pain control', 'postoperative pain', 'Pain intensity', 'level of pain']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0948192', 'cui_str': 'Primary infection NOS'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011407', 'cui_str': 'Necrosis of the pulp'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0059247', 'cui_str': 'Steroid containing root canal medicament'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.057277,It is concluded that photodynamic therapy had a significant effect on decreasing post-endodontic treatment pain in teeth with necrotic pulp and asymptomatic periapical lesions.,"[{'ForeName': 'Esdras Gabriel', 'Initials': 'EG', 'LastName': 'Alves-Silva', 'Affiliation': 'Department of Restorative Dentistry, Division of Endodontics, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, SP, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Arruda-Vasconcelos', 'Affiliation': 'Department of Restorative Dentistry, Division of Endodontics, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, SP, Brazil.'}, {'ForeName': 'Lidiane Mendes', 'Initials': 'LM', 'LastName': 'Louzada', 'Affiliation': 'Department of Restorative Dentistry, Division of Endodontics, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, SP, Brazil.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'de-Jesus-Soares', 'Affiliation': 'Department of Restorative Dentistry, Division of Endodontics, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, SP, Brazil. Electronic address: ajsoares@unicamp.br.'}, {'ForeName': 'Caio Cezar Randi', 'Initials': 'CCR', 'LastName': 'Ferraz', 'Affiliation': 'Department of Restorative Dentistry, Division of Endodontics, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, SP, Brazil. Electronic address: cferraz@unicamp.br.'}, {'ForeName': 'José Flávio Affonso', 'Initials': 'JFA', 'LastName': 'Almeida', 'Affiliation': 'Department of Restorative Dentistry, Division of Endodontics, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, SP, Brazil. Electronic address: jflavio@unicamp.br.'}, {'ForeName': 'Marina Angélica', 'Initials': 'MA', 'LastName': 'Marciano', 'Affiliation': 'Department of Restorative Dentistry, Division of Endodontics, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, SP, Brazil. Electronic address: marinama@unicamp.br.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Steiner-Oliveira', 'Affiliation': 'Department of Health Sciences and Pediatric Dentistry, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, SP, Brazil. Electronic address: csteiner@unicamp.br.'}, {'ForeName': 'Marina Stella', 'Initials': 'MS', 'LastName': 'Bello-Silva', 'Affiliation': 'Special Laboratory of Lasers in Dentistry (LELO), Department of Restorative Dentistry, School of Dentistry, University of São Paulo, SP, Brazil. Electronic address: marinastella@alumni.usp.br.'}, {'ForeName': 'Hagay', 'Initials': 'H', 'LastName': 'Shemesh', 'Affiliation': 'Department of Endodontology, Academic Centre for Dentistry of Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands. Electronic address: h.shemesh@acta.nl.'}, {'ForeName': 'Brenda Paula Figueiredo de Almeida', 'Initials': 'BPFA', 'LastName': 'Gomes', 'Affiliation': 'Department of Restorative Dentistry, Division of Endodontics, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, SP, Brazil. Electronic address: bpgomes@fop.unicamp.br.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102700']
3551,35026342,"A multicenter, randomized, double-blinded, placebo-controlled, dose-ranging study evaluating the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis.","BACKGROUND


Vunakizumab (SHR-1314) is a novel interleukin 17A monoclonal antibody that has shown preliminary efficacy and tolerability in phase I trials.
OBJECTIVE


To evaluate the efficacy and safety of vunakizumab in moderate-to-severe plaque psoriasis.
METHODS


In this 36-week, multicenter, double-blinded, phase II study (NCT03463187), 187 eligible patients with moderate-to-severe plaque psoriasis were randomized 1:1:1:1:1 to receive vunakizumab (40, 80, 160, or 240 mg) or placebo subcutaneously, every 4 weeks, until week 12 (2 more drug administrations for the vunakizumab groups on weeks 16 and 20). The primary end point was at least 75% improvement in the Psoriasis Area and Severity Index at week 12.
RESULTS


At week 12, there were significantly greater proportions of responders with at least 75% improvement in the Psoriasis Area and Severity Index in all vunakizumab groups compared to placebo (40, 80, 160, and 240 mg: 56.8%, 65.8%, 81.6%, and 86.5%, respectively, vs 5.4%; P < .001 for all); the proportions of patients achieving Physician's Global Assessment responses of 0 or 1 were also higher with vunakizumab (45.9%, 47.4%, 60.5%, and 73.0%, respectively, vs 8.1%). No unexpected adverse effects were observed.
LIMITATIONS


The study was relatively short in duration and included no active control.
CONCLUSION


Vunakizumab showed promising efficacy for moderate-to-severe plaque psoriasis, with good tolerability, warranting further investigation in larger and longer-term studies.",2022,"At week 12, there were significantly greater proportions of PASI 75 responders in all vunakizumab groups compared to placebo (40, 80, 160, 240 mg: 56.8%, 65.8%, 81.6%, 86.5% vs 5.4%; all P < .001); the proportions of patients achieving physician's global assessment response of 0 or 1 were also higher with vunakizumab (45.9%, 47.4%, 60.5%, 73.0% vs 8.1%).","['187 eligible patients with moderate-to-severe plaque psoriasis', 'Patients with Moderate-to-Severe Plaque Psoriasis']","['placebo', 'vunakizumab', 'Vunakizumab (SHR-1314', 'Placebo', 'Vunakizumab']","['psoriasis area and severity index', ""proportions of patients achieving physician's global assessment response"", 'adverse effects', 'efficacy and safety']","[{'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1439030', 'cui_str': 'SHORT ROOT protein, Arabidopsis'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",187.0,0.247221,"At week 12, there were significantly greater proportions of PASI 75 responders in all vunakizumab groups compared to placebo (40, 80, 160, 240 mg: 56.8%, 65.8%, 81.6%, 86.5% vs 5.4%; all P < .001); the proportions of patients achieving physician's global assessment response of 0 or 1 were also higher with vunakizumab (45.9%, 47.4%, 60.5%, 73.0% vs 8.1%).","[{'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Dermatology, Peking University Third Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Kexiang', 'Initials': 'K', 'LastName': 'Yan', 'Affiliation': ""Department of Dermatology, Huashan Hospital Affiliated to Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Qingchun', 'Initials': 'Q', 'LastName': 'Diao', 'Affiliation': ""Department of Dermatology, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, People's Republic of China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': ""Department of Dermatology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Hongzhong', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': ""Department of Dermatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Institute of Dermatology and Department of Dermatology, The First Affiliated Hospital of Anhui Medical University, Hefei, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Dermatology, Xiangya Hospital, Central South University, Changsha, People's Republic of China.""}, {'ForeName': 'Tiechi', 'Initials': 'T', 'LastName': 'Lei', 'Affiliation': ""Department of Dermatology, Renmin Hospital of Wuhan University/Hubei General Hospital, Wuhan, People's Republic of China.""}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Dermatology, Changhai Hospital of Shanghai, Shanghai, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Dermatology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': ""Department of Dermatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, People's Republic of China.""}, {'ForeName': 'Xinghua', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Dermatology, The 1st Hospital of China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Sinclair', 'Affiliation': 'Sinclair Dermatology, East Melbourne, Australia.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': ""Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, People's Republic of China.""}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Dermatology, Huashan Hospital Affiliated to Fudan University, Shanghai, People's Republic of China. Electronic address: xjhhsyy@163.com.""}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2022.01.005']
3552,35034024,Novel Renal Autologous Cell Therapy for Type 2 Diabetes Mellitus Chronic Diabetic Kidney Disease: Clinical Trial Design.,"BACKGROUND


Cell therapies explore unmet clinical needs of patients with chronic kidney disease with the potential to alter the pathway toward end-stage kidney disease. We describe the design and baseline patient characteristics of a phase II multicenter clinical trial utilizing the novel renal autologous cell therapy (REACT), by direct kidney parenchymal injection via the percutaneous approach in adults with type 2 diabetic kidney disease (T2DKD), to delay or potentially avoid renal replacement therapy.
DESIGN


The study conducted a prospective, multicenter, randomized control, open-label, phase II clinical trial between an active treatment group (ATG) receiving REACT from the beginning of the trial and a contemporaneous deferred treatment group (DTG) receiving standard of care for 12 months before crossing over to receive REACT.
OBJECTIVES


The objective of this study was to establish the safety and efficacy of 2 REACT injections with computed tomography guidance, into the renal cortex of patients with T2DKD administered 6 months apart, and to compare the longitudinal change in renal function between the ATG and the DTG.
SETTING


This was a multicenter study conducted in major US hospitals.
PATIENTS


We enrolled eighty-three adult patients with T2DKD, who have estimated glomerular filtration rates (eGFRs) between 20 and 50 mL/min/1.73 m2.
METHODS


All patients undergo an image-guided percutaneous kidney biopsy to obtain epithelial phenotype selective renal cells isolated from the kidney tissue that is then expanded ex vivo over 4-6 weeks, resulting in the REACT biologic product. Patients are randomized 1:1 into the ATG or the DTG. Primary efficacy endpoints for both study groups include eGFR measurements at baseline and at 3-month intervals, through 24 months after the last REACT injection. Safety analyses include biopsy-related complications, REACT injection, and cellular-related adverse events. The study utilizes Good Clinical and Manufacturing Practices and a Data and Safety Monitoring Board. The sample size confers a statistical power of 80% to detect an eGFR change in the ATG compared to the DTG at 24 months with an α = 0.05.
LIMITATIONS


Blinding cannot occur due to the intent to treat procedure, biopsy in both groups, and open trial design.
CONCLUSION


This multicenter phase II randomized clinical trial is designed to determine the efficacy and safety of REACT in improving or stabilizing renal function among patients with T2DKD stages 3a-4.",2022,"The sample size confers a statistical power of 80% to detect an eGFR change in the ATG compared to the DTG at 24 months with an α = 0.05.
","['patients with T2DKD stages 3a-4', 'patients with chronic kidney disease with the potential to alter the pathway toward end-stage kidney disease', 'adults with type 2 diabetic kidney disease (T2DKD), to delay or potentially avoid renal replacement therapy', 'enrolled eighty-three adult patients with T2DKD, who have estimated glomerular filtration rates (eGFRs) between 20 and 50 mL/min/1.73 m2', 'major US hospitals', 'Type 2 Diabetes Mellitus Chronic Diabetic Kidney Disease']","['active treatment group (ATG) receiving REACT', 'novel renal autologous cell therapy (REACT), by direct kidney parenchymal injection via the percutaneous approach', 'Novel Renal Autologous Cell Therapy', 'REACT injections with computed tomography guidance', 'REACT', 'contemporaneous deferred treatment group (DTG) receiving standard of care for 12 months before crossing over to receive REACT']","['biopsy-related complications, REACT injection, and cellular-related adverse events', 'renal function', 'eGFR change', 'safety and efficacy', 'eGFR measurements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0302189', 'cui_str': 'Therapy, Cell'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}]","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0302189', 'cui_str': 'Therapy, Cell'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",83.0,0.0463532,"The sample size confers a statistical power of 80% to detect an eGFR change in the ATG compared to the DTG at 24 months with an α = 0.05.
","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Stavas', 'Affiliation': 'ProKidney, Raleigh, North Carolina, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gerber', 'Affiliation': 'Department of Surgery, The University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Coca', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mt. Sinai, New York, New York, USA.'}, {'ForeName': 'Arnold L', 'Initials': 'AL', 'LastName': 'Silva', 'Affiliation': 'Boise Kidney and Hypertension, Boise, Idaho, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Johns', 'Affiliation': 'ProKidney, Raleigh, North Carolina, USA.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'ProKidney, Raleigh, North Carolina, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Bertram', 'Affiliation': 'ProKidney, Raleigh, North Carolina, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Díaz-González de Ferris', 'Affiliation': 'Department of Pediatrics, The University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, The University of Chicago, Chicago, Illinois, USA.'}]",American journal of nephrology,['10.1159/000520231']
3553,35032443,"Chlorhexidine gluconate bathing of adult patients in intensive care units in São Paulo, Brazil: Impact on the incidence of healthcare-associated infection.","BACKGROUND


There is an increasing use of daily chlorhexidine gluconate (CHG) bathing to decrease healthcare associated infections (HAI). Daily bathing of patients with CHG has been successfully used to prevent multidrug-resistant organisms (MDROs) HAI in intensive care units (ICU).
METHODS


This was a 12-month, single-center, open, cluster randomized trial, conducted at four ICUs of the University Hospital of Universidade Federal de São Paulo, Unifesp, Brazil. ICUs were randomized to either perform daily bathing of the patients with pH neutral soap and water - control units, or daily bathing with 2% CHG detergent solution - intervention units. We evaluated the incidence density rate of central line-associated bloodstream infection (CLABSI), ventilator-associated pneumonia (VAP), catheter associated urinary tract infection (CAUTI), Klebsiella pneumoniae carbapenemase (KPC)-producing enterobacteria HAI, and death in the intervention and control units.
RESULTS


A total of 1,640 admissions of 1,487 patients occurred during the study period (41.2% control group, and 58.8% intervention group). Incidence density rates of KPC-producing enterobacteria HAI were 5.01 and 2.25 infections/1000 patient-days in the control units and in the intervention units (p = 0.013) and mortality rates were 28.7% and 18.7% in the control units and in the intervention units (p<0.001), respectively. No difference between groups was observed in CLABSI incidence (p = 0.125), VAP incidence (p = 0.247) and CAUTI incidence (p = 0.435). No serious skin reactions were noted in either study group. Daily 2% CHG detergent solution bathing is a feasible, low cost option for HAI prevention in ICU.",2022,"No difference between groups was observed in CLABSI incidence (p = 0.125), VAP incidence (p = 0.247) and CAUTI incidence (p = 0.435).","['conducted at four ICUs of the University Hospital of Federal University of São Paulo, Brazil', 'A total of 1,640 admissions of 1,487 patients occurred during the study period (41.2% control group, and 58.8% intervention group', 'adult patients in intensive care units in São Paulo, Brazil']","['chlorhexidine gluconate (CHG', 'pH neutral soap and water - control units, or daily bathing with 2% CHG detergent solution - intervention units', 'Chlorhexidine gluconate']","['mortality rates', 'serious skin reactions', 'Incidence density rates of KPC-producing enterobacteria HAI', 'CLABSI incidence', 'incidence density rate of central line-associated bloodstream infection (CLABSI), ventilator-associated pneumonia (VAP), catheter associated urinary tract infection (CAUTI), Klebsiella pneumoniae carbapenemase (KPC)-producing enterobacteria HAI, and death', 'VAP incidence']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C3873701', 'cui_str': 'Control unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011740', 'cui_str': 'Detergent'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1855645', 'cui_str': 'Keratoconus posticus circumscriptus'}, {'cui': 'C0014346', 'cui_str': 'Enterobacteriaceae'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0001699', 'cui_str': 'Klebsiella pneumoniae'}, {'cui': 'C0246081', 'cui_str': 'carbapenemase'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}]",1640.0,0.0415057,"No difference between groups was observed in CLABSI incidence (p = 0.125), VAP incidence (p = 0.247) and CAUTI incidence (p = 0.435).","[{'ForeName': 'Mariana Andrade Oliveira', 'Initials': 'MAO', 'LastName': 'Reis', 'Affiliation': 'Infectious Diseases Department, Hospital São Paulo, Universidade Federal de São Paulo, SP, Brazil.'}, {'ForeName': 'Maria Claudia Stockler', 'Initials': 'MCS', 'LastName': 'de Almeida', 'Affiliation': 'Division of Infectious Diseases, Hospital das Clínicas, Universidade de São Paulo - FMUSP School of Medicine, SP, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Escudero', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Hospital São Paulo, Universidade Federal de São Paulo, Unifesp, SP, Brazil.'}, {'ForeName': 'Eduardo A', 'Initials': 'EA', 'LastName': 'Medeiros', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Hospital São Paulo, Universidade Federal de São Paulo, Unifesp, SP, Brazil; Department of Hospital Epidemiology and Antimicrobial Stewardship of Hospital São Paulo, Universidade Federal de São Paulo, Unifesp, SP, Brazil. Electronic address: edubalaccih@gmail.com.'}]",The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases,['10.1016/j.bjid.2021.101666']
3554,35032643,Time course of human skeletal muscle nitrate and nitrite concentration changes following dietary nitrate ingestion.,"Dietary nitrate (NO 3 - ) ingestion can be beneficial for health and exercise performance. Recently, based on animal and limited human studies, a skeletal muscle NO 3 -  reservoir has been suggested to be important in whole body nitric oxide (NO) homeostasis. The purpose of this study was to determine the time course of changes in human skeletal muscle NO 3 -  concentration ([NO 3 - ]) following the ingestion of dietary NO 3 - . Sixteen participants were allocated to either an experimental group (NIT: n = 11) which consumed a bolus of ∼1300 mg (12.8 mmol) potassium nitrate (KNO 3 ), or a placebo group (PLA: n = 5) which consumed a bolus of potassium chloride (KCl). Biological samples (muscle (vastus lateralis), blood, saliva and urine) were collected shortly before NIT or PLA ingestion and at intervals over the course of the subsequent 24 h. At baseline, no differences were observed for muscle [NO 3 - ] and [NO 2 - ] between NIT and PLA (P > 0.05). In PLA, there were no changes in muscle [NO 3 - ] or [NO 2 - ] over time. In NIT, muscle [NO 3 - ] was significantly elevated above baseline (54 ± 29 nmol/g) at 0.5 h, reached a peak at 3 h (181 ± 128 nmol/g), and was not different to baseline from 9 h onwards (P > 0.05). Muscle [NO 2 - ] did not change significantly over time. Following ingestion of a bolus of dietary NO 3 - , skeletal muscle [NO 3 - ] increases rapidly, reaches a peak at ∼3 h and subsequently declines towards baseline values. Following dietary NO 3 -  ingestion, human m. vastus lateralis [NO 3 - ] expressed a slightly delayed pharmacokinetic profile compared to plasma [NO 3 - ].",2022,"At baseline, no differences were observed for muscle [NO 3 - ] and",['Sixteen participants'],"['experimental group (NIT: n\u202f=\u202f11) which consumed a bolus of ∼1300\u202fmg (12.8\u202fmmol) potassium nitrate (KNO 3 ), or a placebo group (PLA: n\u202f=\u202f5) which consumed a bolus of potassium chloride (KCl', 'dietary nitrate ingestion', 'Dietary nitrate (NO 3 - ) ingestion']","['Muscle ', 'Biological samples (muscle (vastus lateralis), blood, saliva and urine']","[{'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030757', 'cui_str': 'Pediculosis capitis'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0071772', 'cui_str': 'potassium nitrate'}, {'cui': 'C1849409', 'cui_str': 'Retinal detachment and occipital encephalocele'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0032825', 'cui_str': 'Potassium Chloride'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0042036', 'cui_str': 'Urine'}]",16.0,0.122538,"At baseline, no differences were observed for muscle [NO 3 - ] and","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kadach', 'Affiliation': ""University of Exeter, College of Life and Environmental Sciences, St Luke's Campus, University of Exeter, Exeter, EX1 2LU, UK.""}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Piknova', 'Affiliation': 'Molecular Medicine Branch, NIDDK, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Matthew I', 'Initials': 'MI', 'LastName': 'Black', 'Affiliation': ""University of Exeter, College of Life and Environmental Sciences, St Luke's Campus, University of Exeter, Exeter, EX1 2LU, UK.""}, {'ForeName': 'Ji Won', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Molecular Medicine Branch, NIDDK, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Lee J', 'Initials': 'LJ', 'LastName': 'Wylie', 'Affiliation': ""University of Exeter, College of Life and Environmental Sciences, St Luke's Campus, University of Exeter, Exeter, EX1 2LU, UK.""}, {'ForeName': 'Zdravko', 'Initials': 'Z', 'LastName': 'Stoyanov', 'Affiliation': ""University of Exeter, College of Life and Environmental Sciences, St Luke's Campus, University of Exeter, Exeter, EX1 2LU, UK.""}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Thomas', 'Affiliation': 'Molecular Medicine Branch, NIDDK, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'McMahon', 'Affiliation': 'University of Queensland, School of Human Movement and Nutrition Sciences, University of Queensland, St Lucia, QLD, 4072, Australia.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Vanhatalo', 'Affiliation': ""University of Exeter, College of Life and Environmental Sciences, St Luke's Campus, University of Exeter, Exeter, EX1 2LU, UK.""}, {'ForeName': 'Alan N', 'Initials': 'AN', 'LastName': 'Schechter', 'Affiliation': 'Molecular Medicine Branch, NIDDK, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Jones', 'Affiliation': ""University of Exeter, College of Life and Environmental Sciences, St Luke's Campus, University of Exeter, Exeter, EX1 2LU, UK. Electronic address: a.m.jones@exeter.ac.uk.""}]",Nitric oxide : biology and chemistry,['10.1016/j.niox.2022.01.003']
3555,34921820,"Baseline anxiety, and early anxiety/depression improvement in anxious depression predicts treatment outcomes with escitalopram: A CAN-BIND-1 study report.","INTRODUCTION


Although anxiety symptoms frequently co-occur with major depressive disorder, few studies examined the prediction of treatment outcomes among participants with anxious depression receiving antidepressants. We investigated whether baseline anxiety, and early improvements in anxiety and depression symptoms predict eventual treatment outcomes.
METHODS


111 participants with anxious depression, defined using ≥ 10 on GAD-7, received escitalopram (10-20 mg) for 8 weeks. Covariate-adjusted logistic regression was conducted to examine the impact of baseline anxiety, and to assess the extent week 2 anxiety (GAD-7) and depression (QIDS-SR) percentage improvement associates with week 8 anxiety (GAD-7) and depression (MADRS) response/remission. Optimum improvement thresholds were identified using receiving-operating-curve analysis and their predictive values assessed.
RESULTS


Greater percentage improvement in anxiety and depression after the first 2 weeks of treatment significantly increased odds of achieving week 8 anxiety and depression response/remission (OR:1.01-1.04, p<0.05). Early anxiety (68.4%/87.2%) and depression (52.2%/83.0%) improvement thresholds around 30 and 40% provided moderate to high positive predictive value (PPV) for predicting week 8 anxiety response/remission, as well as moderate to high negative predictive value (NPV) for predicting week 8 depression response/remission (anxiety:70.8%/91.7%; depression:72.2%/90.1%). Baseline anxiety severity predicted anxiety outcomes at weeks 2 and 8.
LIMITATIONS


Trial lacked placebo group.
CONCLUSION


In anxious depression, early improvement in anxiety may be better than depression in predicting anxiety outcomes, with similar or higher PPVs. Both improvement types perform similarly in predicting depression outcomes, with the lack of improvement predictive of non-response and non-remission. Finally, baseline anxiety predicts eventual anxiety but not depression outcomes.",2022,"significantly increased odds of achieving week 8 anxiety and depression response/remission (OR:1.01-1.04, p<0.05).","['participants with anxious depression receiving antidepressants', '111 participants with anxious depression, defined using ≥ 10 on GAD-7, received escitalopram (10-20\xa0mg) for 8 weeks']","['placebo', 'escitalopram']","['anxiety and depression', 'Baseline anxiety, and early anxiety/depression improvement', 'depression', 'anxiety (GAD-7) and depression (QIDS-SR) percentage improvement associates with week 8 anxiety (GAD-7) and depression (MADRS) response/remission', 'Baseline anxiety severity predicted anxiety outcomes', 'Early anxiety', 'odds of achieving week 8 anxiety and depression response/remission']","[{'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",111.0,0.0813762,"significantly increased odds of achieving week 8 anxiety and depression response/remission (OR:1.01-1.04, p<0.05).","[{'ForeName': 'Yuelee', 'Initials': 'Y', 'LastName': 'Khoo', 'Affiliation': ""Interventional Psychiatry Program, Centre for Depression & Suicide Studies, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Demchenko', 'Affiliation': ""Interventional Psychiatry Program, Centre for Depression & Suicide Studies, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Benicio N', 'Initials': 'BN', 'LastName': 'Frey', 'Affiliation': ""Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada; Mood Disorders Program and Women's Health Concerns Clinic, St. Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Roumen V', 'Initials': 'RV', 'LastName': 'Milev', 'Affiliation': ""Departments of Psychiatry and Psychology, Queen's University, Providence Care, Kingston, Ontario, Canada.""}, {'ForeName': 'Arun V', 'Initials': 'AV', 'LastName': 'Ravindran', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sagar V', 'Initials': 'SV', 'LastName': 'Parikh', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, United States.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Ho', 'Affiliation': ""Interventional Psychiatry Program, Centre for Depression & Suicide Studies, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Rotzinger', 'Affiliation': ""Interventional Psychiatry Program, Centre for Depression & Suicide Studies, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lou', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Sidney H', 'Initials': 'SH', 'LastName': 'Kennedy', 'Affiliation': ""Interventional Psychiatry Program, Centre for Depression & Suicide Studies, St. Michael's Hospital, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute & Krembil Research Institute, Toronto, Ontario, Canada.""}, {'ForeName': 'Venkat', 'Initials': 'V', 'LastName': 'Bhat', 'Affiliation': ""Interventional Psychiatry Program, Centre for Depression & Suicide Studies, St. Michael's Hospital, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute & Krembil Research Institute, Toronto, Ontario, Canada. Electronic address: venkat.bhat@utoronto.ca.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of affective disorders,['10.1016/j.jad.2021.12.027']
3556,35045323,Are patterns of family evening meal practices associated with child and parent diet quality and weight-related outcomes?,"Family meal practices such as family member presence, fast food consumption and media usage have been associated with health outcomes. However, little is known about combinations of family meal practices and their effects on diet and health. This secondary data analysis aimed to identify patterns of family evening meal practices and examine their associations with family characteristics (e.g., demographics and chaos) and child and parent diet quality and weight-related outcomes. We used baseline data from a community-based randomized controlled trial with 7- to 10-year-old children and their parents in rural Minnesota (n = 114). Parent-reported structural (e.g. media usage) and interpersonal (e.g. mealtime routines) aspects of family evening meal practices were included in latent profile analyses to identify patterns. Diet quality was assessed by child Healthy Eating Index-2015 and parent fruit and vegetable intake. Weight-related outcomes were determined using measured body mass index (z-scores) and percent body fat. A 3-class model was the model of best-fit. The Unplanned Infrequent Family Evening Meals with Mixed Healthfulness class (C1) featured the least frequent family evening meals and the lowest scores for mealtime routines and planning skills. The Family Evening Meals with Fast Food class (C2) characterized having family evening meals four times a week, but fast food was often served. The Planful, Healthful and Frequent Family Evening Meals class (C3) reported the highest meal routine and planning scores as well as frequent family evening meals. Parents in C3 had higher consumption of fruits and vegetables and children in C3 had lower percent body fat, compared to those in other classes. Distinctly different patterns of family evening meal practices suggest a need for considering heterogeneity of family evening meal practices in developing tailored family-meal interventions.",2022,"Parents in C3 had higher consumption of fruits and vegetables and children in C3 had lower percent body fat, compared to those in other classes.",['10-year-old children and their parents in rural Minnesota (n\xa0=\xa0114'],[],"['higher consumption of fruits and vegetables', 'Diet quality']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C4708785', 'cui_str': '114'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0330006,"Parents in C3 had higher consumption of fruits and vegetables and children in C3 had lower percent body fat, compared to those in other classes.","[{'ForeName': 'Jiwoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, University of Minnesota, 308 Harvard St. S.E., Minneapolis, MN, 55455, USA. Electronic address: leex5222@umn.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Friend', 'Affiliation': 'School of Nursing, University of Minnesota, 308 Harvard St. S.E., Minneapolis, MN, 55455, USA. Electronic address: adki0032@umn.edu.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Horning', 'Affiliation': 'School of Nursing, University of Minnesota, 308 Harvard St. S.E., Minneapolis, MN, 55455, USA. Electronic address: horn0199@umn.edu.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Linde', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, 1300 S. 2nd St., Suite 300, Minneapolis, MN, 55454, USA. Electronic address: linde074@umn.edu.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Flattum', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, 1300 S. 2nd St., Suite 300, Minneapolis, MN, 55454, USA. Electronic address: flatt018@umn.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lindberg', 'Affiliation': 'Rebecca E. Lindberg, LLC, 4629 Arden Avenue, Edina, MN, 55424, USA. Electronic address: relindberg@gmail.com.'}, {'ForeName': 'Jayne A', 'Initials': 'JA', 'LastName': 'Fulkerson', 'Affiliation': 'School of Nursing, University of Minnesota, 308 Harvard St. S.E., Minneapolis, MN, 55455, USA. Electronic address: fulke001@umn.edu.'}]",Appetite,['10.1016/j.appet.2022.105937']
3557,35055603,The Effect of an Informative Video upon Anxiety and Stress in Patients Requiring an Oral Biopsy: A Randomized Controlled Study.,"OBJECTIVE


The use of multimedia tools improves patient understanding of surgical procedures, reduces anxiety and increases satisfaction. The present study evaluates the impact of an audiovisual intervention (video) upon anxiety and stress in patients requiring an oral biopsy.
MATERIAL AND METHODS


A prospective randomized clinical trial was carried out in patients requiring an oral biopsy. The control group ( n  = 60) received verbal standard information while the experimental group ( n  = 60) received information in the form of a video. The following data were recorded: gender, age, educational level and hemodynamic parameters (blood pressure, heart rate and blood oxygen saturation). The following questionnaires were used to assess anxiety and stress before and after the biopsy procedure: Corah's Modified Dental Anxiety Scale (MDAS), the State-Trait Anxiety Inventory (STAI) and the Hospital Anxiety and Depression Scale (HADS).
RESULTS


The final study sample consisted of 120 patients, of which 65.8% were women and 34.2% men, with a mean age of 40.5 ± 15.3 years. At the end of the study, the experimental group presented a significantly lower MDAS score than the control group ( p  = 0.041). The STAI score also showed a significant decrease with respect to the control group at the end of the study ( p  = 0.012). There were no statistically significant changes in the hemodynamic parameters in either group.
CONCLUSIONS


The video constituted a useful and easy tool for reducing anxiety among patients requiring an oral biopsy.",2022,The STAI score also showed a significant decrease with respect to the control group at the end of the study ( p  = 0.012).,"['120 patients, of which 65.8% were women and 34.2% men, with a mean age of 40.5 ± 15.3 years', 'patients requiring an oral biopsy', 'Patients Requiring an Oral Biopsy']","['verbal standard information', 'Informative Video', 'audiovisual intervention (video']","['STAI score', 'educational level and hemodynamic parameters (blood pressure, heart rate and blood oxygen saturation', 'anxiety and stress', ""Corah's Modified Dental Anxiety Scale (MDAS), the State-Trait Anxiety Inventory (STAI) and the Hospital Anxiety and Depression Scale (HADS"", 'hemodynamic parameters', 'MDAS score']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5191359', 'cui_str': '34.2'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}]",120.0,0.0312077,The STAI score also showed a significant decrease with respect to the control group at the end of the study ( p  = 0.012).,"[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Toralla', 'Affiliation': 'Departamento Odontologia, Universidad San Carlos de Guatemala, Guatemala 01018, Guatemala.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Lopez Jornet', 'Affiliation': 'Faculty of Medicine and Odontology, University of Murcia, 30008 Murcia, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Pons-Fuster', 'Affiliation': 'Faculty of Medicine and Odontology, University of Murcia, 30008 Murcia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph19020783']
3558,35046640,Dexmedetomidine Combined with Femoral Nerve Block Provides Effective Analgesia Similar to Femoral Nerve Combined with Sciatic Nerve Block in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Study.,"Background


Total knee arthroplasty (TKA) is a severe traumatic procedure, and femoral nerve block (FNB) combined with a sciatic nerve block (SNB) is widely used in TKA. However, injury of the sciatic nerve is clinically reported. Dexmedetomidine (DEX) could reduce stress and inflammation, as well as improve pain in TKA. This study aims to observe the analgesic impact of DEX combined with FNB in TKA.
Methods


Eighty-eight patients undergoing TKA were included and randomly divided into two groups: DF group (FNB combined with DEX 0.6μg/kg before surgery, followed by DEX 0.2-0.4μg/kg/h until articular closure) and SF group (FNB combined with SNB). Each nerve was blocked with 0.375% ropivacaine 20mL, and all patients received general anesthesia routinely. The primary endpoint was the pain visual analog scale (VAS) score during activities at postoperative 24 hours.
Results


There was no statistical difference in the pain VAS scores at any time point. The mean duration of analgesia for patients with rescue analgesic requests was comparable between the two groups: 25.4 ± 6.3 hours in the DF group vs 24.8 ± 6.4 hours in the SF group (two-sample  t -test, p=0.738). The total dose of sufentanil was similar between groups (P=0.355). The maintenance dose of propofol and dose of rescue analgesics were comparable (all P>0.05). There were no statistical differences in the incidence of adverse events. However, the time to extubate in the DF group was significantly longer than those in the SF group (P<0.001).
Conclusion


DEX combined with FNB could provide effective analgesia similar to SNB combined with FNB in TKA.
Clinical Trial Registration


The trial was registered at the Chinese Clinical Trial Registry on November 17, 2019 (identifier: ChiCTR1900027552).",2022,The maintenance dose of propofol and dose of rescue analgesics were comparable (all P>0.05).,"['Patients Undergoing Total Knee Arthroplasty', 'Methods\n\n\nEighty-eight patients undergoing TKA']","['\n\n\nTotal knee arthroplasty (TKA', 'general anesthesia routinely', 'ropivacaine', 'DF group (FNB combined with DEX 0.6μg/kg before surgery, followed by DEX 0.2-0.4μg/kg/h until articular closure) and SF group (FNB combined with SNB', 'Dexmedetomidine (DEX', 'Femoral Nerve Combined with Sciatic Nerve Block', 'sciatic nerve block (SNB', 'propofol', 'Dexmedetomidine Combined with Femoral Nerve Block', 'DEX', 'sufentanil']","['incidence of adverse events', 'pain VAS scores', 'pain visual analog scale (VAS) score during activities at postoperative 24 hours', 'mean duration of analgesia', 'time to extubate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517898', 'cui_str': '88'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve'}, {'cui': 'C0015808', 'cui_str': 'Structure of femoral nerve'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}]",88.0,0.221175,The maintenance dose of propofol and dose of rescue analgesics were comparable (all P>0.05).,"[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Xiao', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, Hefei, Anhui, 230022, People's Republic of China.""}, {'ForeName': 'Li-Fang', 'Initials': 'LF', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, Hefei, Anhui, 230022, People's Republic of China.""}, {'ForeName': 'Ya-Ru', 'Initials': 'YR', 'LastName': 'Luo', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, Hefei, Anhui, 230022, People's Republic of China.""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, Hefei, Anhui, 230022, People's Republic of China.""}, {'ForeName': 'Xiao-Bin', 'Initials': 'XB', 'LastName': 'Jin', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, Hefei, Anhui, 230022, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, Hefei, Anhui, 230022, People's Republic of China.""}, {'ForeName': 'Guang-Hong', 'Initials': 'GH', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, Hefei, Anhui, 230022, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S334415']
3559,35051670,A randomized controlled trial of sleep study surveillance with targeted autoregulated positive airway pressure therapy for obstructive sleep apnea in pregnancy.,"BACKGROUND


Obstructive sleep apnea is associated with adverse pregnancy outcomes. The impact therapy for obstructive sleep apnea has on these pregnancy outcomes remains under investigated.
OBJECTIVE


This study aimed to determine the effects of targeted autoregulated positive airway pressure in women at risk of obstructive sleep apnea on adverse pregnancy outcomes, cost, and natural history of obstructive sleep apnea.
STUDY DESIGN


Pregnant women at high risk of obstructive sleep apnea were randomized to either a sleep study screening group receiving autoregulated positive airway therapy or a group not screened for obstructive sleep apnea receiving standard obstetrical care (control). Women in the sleep study-screened group received a sleep study at 2 periods during pregnancy, early (6-16 weeks of gestation) and late (27-33 weeks of gestation), with initiation of autoregulated positive airway therapy if their Apnea Hypopnea Index indicated ≥5 events per hour. Women of both groups had a sleep study 3 months after delivery. The primary outcome was effect on adverse pregnancy outcomes, a composite of hypertension, preterm birth, low birthweight, stillbirth, and diabetes mellitus. The secondary outcomes included obstructive sleep apnea severity and hospital costs.
RESULTS


Among 193 women randomized (100 in the sleep study-screened group and 93 in the control group; 6 lost to follow-up), there was no significant difference in composite adverse pregnancy outcomes (46.4% screened vs 43.3% control; P=.77), hypertension (23.7% screened vs 32.0% control; P=.25), preterm birth (13.4% screened vs 10.0% control; P=.5), low birthweight (5.2% screened vs 6.7% control; P=.76), stillbirth (1% screened vs 0% control; P=1), gestational diabetes (19.6% screened vs 13.3% control; P=.33), or mean cost ($12,185 screened vs $12,607 control). The Apnea Hypopnea Index increased throughout pregnancy, peaking at 3 months after delivery (P<.001). There were 24 subjects (25.8%) who had a new diagnosis of obstructive sleep apnea, with 6 in whom autoregulated positive airway was prescribed. The autoregulated positive airway compliance rates were poor with usage rates ranging from 2% (1 of 64 days) to 43% (6 of 14 days).
CONCLUSION


Targeted autoregulated positive airway therapy for obstructive sleep apnea did not decrease composite adverse pregnancy outcomes or hospital costs in the sleep study-screened high-risk pregnancy group compared with the group that received no obstructive sleep apnea screening. However, a small sample size, low autoregulated positive airway prescription rates, and poor compliance resulted in difficulty in drawing a definitive conclusion. The prevalence and severity of obstructive sleep apnea worsened throughout pregnancy, with the highest rates detected in the postpartum period. Large, multicenter clinical trials that are adequately powered are needed.",2022,"The AHI increased over the course of pregnancy, peaking at 3 months postpartum (p<.001). ","['Obstructive Sleep Apnea in Pregnancy', 'There were 24 (25.8%) subjects who had a new diagnosis of OSA, with 6 in whom APAP was prescribed', 'Pregnant women at high risk for OSA', '193 women randomized (100 sleep study screened group; 93 control group', 'women at risk for obstructive sleep apnea (OSA']","['targeted autoregulated positive airway pressure (APAP', 'Targeted APAP Therapy', 'sleep study screening group with possible initiation of APAP compared to women not screened for OSA, receiving standard obstetric care (control', 'APAP therapy']","['adverse pregnancy outcomes (APOs), cost, and natural history of OSA', 'hypertension', 'OSA severity and hospital costs', 'prevalence and severity of OSA', 'stillbirth', 'mean cost', 'APAP compliance rates', 'low birthweight', 'APO, a composite of hypertension, preterm birth, low birthweight, stillbirth and diabetes', 'composite adverse pregnancy outcomes or hospital costs', 'preterm birth', 'gestational diabetes', 'composite APO']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}]",193.0,0.126506,"The AHI increased over the course of pregnancy, peaking at 3 months postpartum (p<.001). ","[{'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Kalkhoff', 'Affiliation': 'Department of Gynecologic Surgery and Obstetrics, Naval Medical Center San Diego, San Diego, CA; Department of Gynecologic Surgery and Obstetrics, US Naval Hospital, Yokosuka, Japan. Electronic address: stephen.m.kalkhoff.mil@mail.mil.'}, {'ForeName': 'Monica A', 'Initials': 'MA', 'LastName': 'Lutgendorf', 'Affiliation': 'Department of Gynecologic Surgery and Obstetrics, Naval Medical Center San Diego, San Diego, CA.'}, {'ForeName': 'Theodore C', 'Initials': 'TC', 'LastName': 'Morrison', 'Affiliation': 'Department of Gynecologic Surgery and Obstetrics, Naval Medical Center San Diego, San Diego, CA.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Department of Gynecologic Surgery and Obstetrics, Naval Medical Center San Diego, San Diego, CA.'}, {'ForeName': 'Dennis L', 'Initials': 'DL', 'LastName': 'Spence', 'Affiliation': 'Department of Gynecologic Surgery and Obstetrics, Naval Medical Center San Diego, San Diego, CA.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100571']
3560,34931749,Adjunctive berberine reduces antipsychotic-associated weight gain and metabolic syndrome in patients with schizophrenia: a randomized controlled trial.,"AIM


The aim of this study was to evaluate the efficacy and safety of berberine as an adjuvant in treating antipsychotic-associated weight gain and metabolic syndrome.
METHODS


One hundred thirteen participants with schizophrenia spectrum disorders who had developed metabolic syndrome were recruited. They were randomly assigned to berberine (600 mg/d, n = 58) or placebo (n = 55) groups for 12 weeks. The primary outcome was the change from baseline to week 12 in net weight. Secondary outcomes included body mass index, waist circumference, serum glucose and lipid profiles, and the severity of psychotic symptoms.
RESULTS


Compared with the placebo group, the berberine group showed a significantly greater reduction in weight gain at 9 weeks (mean difference [MD], -0.75; 95% CI, -1.42 to -0.07 [P = 0.031, d = 0.41]) and 12 weeks (MD, -1.08; 95% CI, -1.76 to -0.40 [P = 0.002, d = 0.59]). Patients who received berberine also showed statistically significant improvements in end point in body mass index (MD, -0.41; 95% CI, -0.65 to -0.17 [P = 0.001, d = 0.64]), total cholesterol (MD, -0.58; 95% CI, -0.74 to -0.41 [P < 0.001, d = 1.31]), low-density lipoprotein (MD, -0.52; 95% CI, -0.68 to -0.35 [P < 0.001, d = 1.19]), and glycated hemoglobin (MD, -0.09; 95% CI, -0.18 to 0 [P = 0.05, d = 0.37]). Berberine was well tolerated without serious adverse events and aggravation of psychotic symptoms compared with placebo.
CONCLUSION


The findings suggest that berberine is effective in attenuating antipsychotic-associated weight gain and metabolic syndrome.",2022,"Compared with the placebo group, the berberine group showed a significantly greater reduction in weight gain at 9 weeks (mean difference [MD], -0.75; 95% CI, -1.42 to -0.07","['patients with schizophrenia', 'One hundred thirteen participants with schizophrenia spectrum disorders who had developed metabolic syndrome were recruited']","['berberine', 'placebo']","['weight gain and metabolic syndrome', 'weight gain', 'body mass index', 'low-density lipoprotein', 'efficacy and safety', 'total cholesterol', 'change from baseline to week 12 in net weight', 'tolerated without serious adverse events and aggravation of psychotic symptoms', 'glycated hemoglobin (MD', 'body mass index, waist circumference, serum glucose and lipid profiles, and the severity of psychotic symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0005117', 'cui_str': 'Berberine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",113.0,0.352503,"Compared with the placebo group, the berberine group showed a significantly greater reduction in weight gain at 9 weeks (mean difference [MD], -0.75; 95% CI, -1.42 to -0.07","[{'ForeName': 'MeiYan', 'Initials': 'M', 'LastName': 'Chan', 'Affiliation': 'LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Zongshi', 'Initials': 'Z', 'LastName': 'Qin', 'Affiliation': 'LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sui-Cheung', 'Initials': 'SC', 'LastName': 'Man', 'Affiliation': 'LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lam', 'Affiliation': 'Department of Adult Psychiatry, Castle Peak Hospital, Hong Kong, China.'}, {'ForeName': 'Wing Him', 'Initials': 'WH', 'LastName': 'Lai', 'Affiliation': 'Department of Adult Psychiatry, Castle Peak Hospital, Hong Kong, China.'}, {'ForeName': 'Roger Man Kin', 'Initials': 'RMK', 'LastName': 'Ng', 'Affiliation': 'Department of Psychiatry, Kowloon Hospital, Hong Kong, China.'}, {'ForeName': 'Che Kin', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Kowloon Hospital, Hong Kong, China.'}, {'ForeName': 'Tak Luen', 'Initials': 'TL', 'LastName': 'Wong', 'Affiliation': 'LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Edwin Ho Ming', 'Initials': 'EHM', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Hei Kiu', 'Initials': 'HK', 'LastName': 'Wong', 'Affiliation': 'LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yibin', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Lanying', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, Tongde Hospital of Zhejiang Province, Zhejiang, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Han', 'Affiliation': ""Department of Schizophrenia, Shenyang Jing'an Mental Health Hospital, Shenyang, China.""}, {'ForeName': 'Eric Yu Hai', 'Initials': 'EYH', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Zhang-Jin', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}]",Psychiatry and clinical neurosciences,['10.1111/pcn.13323']
3561,35041780,Balanced Multielectrolyte Solution versus Saline in Critically Ill Adults.,"BACKGROUND


Whether the use of balanced multielectrolyte solution (BMES) in preference to 0.9% sodium chloride solution (saline) in critically ill patients reduces the risk of acute kidney injury or death is uncertain.
METHODS


In a double-blind, randomized, controlled trial, we assigned critically ill patients to receive BMES (Plasma-Lyte 148) or saline as fluid therapy in the intensive care unit (ICU) for 90 days. The primary outcome was death from any cause within 90 days after randomization. Secondary outcomes were receipt of new renal-replacement therapy and the maximum increase in the creatinine level during ICU stay.
RESULTS


A total of 5037 patients were recruited from 53 ICUs in Australia and New Zealand - 2515 patients were assigned to the BMES group and 2522 to the saline group. Death within 90 days after randomization occurred in 530 of 2433 patients (21.8%) in the BMES group and in 530 of 2413 patients (22.0%) in the saline group, for a difference of -0.15 percentage points (95% confidence interval [CI], -3.60 to 3.30; P = 0.90). New renal-replacement therapy was initiated in 306 of 2403 patients (12.7%) in the BMES group and in 310 of 2394 patients (12.9%) in the saline group, for a difference of -0.20 percentage points (95% CI, -2.96 to 2.56). The mean (±SD) maximum increase in serum creatinine level was 0.41±1.06 mg per deciliter (36.6±94.0 μmol per liter) in the BMES group and 0.41±1.02 mg per deciliter (36.1±90.0 μmol per liter) in the saline group, for a difference of 0.01 mg per deciliter (95% CI, -0.05 to 0.06) (0.5 μmol per liter [95% CI, -4.7 to 5.7]). The number of adverse and serious adverse events did not differ meaningfully between the groups.
CONCLUSIONS


We found no evidence that the risk of death or acute kidney injury among critically ill adults in the ICU was lower with the use of BMES than with saline. (Funded by the National Health and Medical Research Council of Australia and the Health Research Council of New Zealand; PLUS ClinicalTrials.gov number, NCT02721654.).",2022,"The number of adverse and serious adverse events did not differ meaningfully between the groups.
","['Critically Ill Adults', 'critically ill patients to receive', 'critically ill patients', 'A total of 5037 patients were recruited from 53 ICUs in Australia and New Zealand - 2515 patients']","['BMES', 'balanced multielectrolyte solution (BMES', 'BMES (Plasma-Lyte 148) or saline as fluid therapy', 'sodium chloride solution (saline', 'Balanced Multielectrolyte Solution versus Saline']","['receipt of new renal-replacement therapy and the maximum increase in the creatinine level during ICU stay', 'mean (±SD) maximum increase in serum creatinine level', 'Death', 'number of adverse and serious adverse events', 'death from any cause']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0071208', 'cui_str': 'Plasma-lyte 148'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",5037.0,0.613406,"The number of adverse and serious adverse events did not differ meaningfully between the groups.
","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finfer', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Micallef', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Hammond', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': 'Leanlove', 'Initials': 'L', 'LastName': 'Navarra', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Delaney', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gallagher', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gattas', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': 'Jayanthi', 'Initials': 'J', 'LastName': 'Mysore', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Saxena', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': 'Colman', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Myburgh', 'Affiliation': 'From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2114464']
3562,34965947,The Effect of Corticosteroids on Prostate Cancer Outcome Following Treatment with Enzalutamide: A Multivariate Analysis of the Phase III AFFIRM Trial.,"PURPOSE


The clinical impact of concurrent corticosteroid use (CCU) on enzalutamide-treated patients with metastatic castration-resistant prostate cancer (mCRPC) is unknown. We investigated the association of CCU with overall survival (OS), radiographic progression-free survival (rPFS), and time to prostate-specific antigen progression (TTPP) in post-chemotherapy, enzalutamide-treated patients with mCRPC.
PATIENTS AND METHODS


Post hoc analysis of AFFIRM (NCT00974311) with patients (n = 1,199) randomized 2:1 to enzalutamide 160 mg/day or placebo. Treatment group, CCU, and known prognostic factors were evaluated for impact on OS, rPFS, and TTPP using a multivariate Cox proportional hazards model. CCU was defined as ""baseline"" (use started at baseline) or ""on-study"" (baseline plus use that was started during the trial).
RESULTS


Enzalutamide significantly improved OS, rPFS, and TTPP independent of baseline CCU but was associated with inferior clinical outcomes when compared with no baseline CCU, including a shorter OS [10.8 months vs. not reached (NR); HR for use vs. no use, 2.13; 95% confidence interval (CI), 1.79-2.54], rPFS (5.2 months vs. 8.0 months; HR, 1.49; 95% CI, 1.29-1.72], and TTPP (4.6 months vs. 5.7 months; HR, 1.50; 95% CI, 1.25-1.81). These findings held in a multivariate analysis adjusting for baseline prognostic factors wherein baseline CCU was independently associated with decreased OS (HR, 1.71; 95% CI, 1.43-2.04; P < 0.0001) and rPFS (HR, 1.28; 95% CI, 1.11-1.48; P = 0.0007).
CONCLUSIONS


Patients with mCRPC benefited from enzalutamide treatment independent of CCU, but CCU was associated with worse baseline prognostic factors and outcomes.",2022,"We investigated the association of CCU with overall survival (OS), radiographic progression-free survival (rPFS), and time to prostate-specific antigen progression (TTPP) in post-chemotherapy, enzalutamide-treated patients with mCRPC.
","['treated patients with mCRPC', 'treated patients with metastatic castration-resistant prostate cancer (mCRPC', 'Post hoc  analysis of AFFIRM (NCT00974311) with patients ( n  = 1,199) randomized 2:1 to']","['enzalutamide 160 mg/day or placebo', 'Enzalutamide', 'Corticosteroids', 'corticosteroid use (CCU', 'CCU', 'enzalutamide']","['overall survival (OS), radiographic progression-free survival (rPFS), and time to prostate-specific antigen progression (TTPP', 'Prostate Cancer Outcome', 'rPFS', 'OS, rPFS, and TTPP independent of baseline CCU']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",1199.0,0.417346,"We investigated the association of CCU with overall survival (OS), radiographic progression-free survival (rPFS), and time to prostate-specific antigen progression (TTPP) in post-chemotherapy, enzalutamide-treated patients with mCRPC.
","[{'ForeName': 'Jimmy L', 'Initials': 'JL', 'LastName': 'Zhao', 'Affiliation': 'Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Department of Cancer Medicine at Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'Department of GU Oncology, University of Montreal Hospital Centre (CHUM), Montreal, Canada.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'Vancouver Prostate Centre, Vancouver, Canada.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Sandra and Edward Meyer Cancer Center, New York, New York.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'Medical Oncology, Duke Cancer Center, Durham, North Carolina.'}, {'ForeName': 'Johann S', 'Initials': 'JS', 'LastName': 'de Bono', 'Affiliation': 'The Institute of Cancer Research and Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Duggan', 'Affiliation': 'Pfizer Inc., Groton, Connecticut.'}, {'ForeName': 'Howard I', 'Initials': 'HI', 'LastName': 'Scher', 'Affiliation': 'Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-21-1090']
3563,34929616,Time to next treatment or death as a candidate surrogate endpoint for overall survival in advanced melanoma patients treated with immune checkpoint inhibitors: an insight from the phase III CheckMate 067 trial.,"BACKGROUND


Time to next treatment or death (TNT-D) may be a patient-relevant endpoint in patients treated with immune checkpoint inhibitors. This study investigated TNT-D as a surrogate endpoint (SE) for overall survival (OS) in previously untreated advanced melanoma patients.
METHODS


Patient-level data from the 60-month results of the CheckMate 067 randomised, controlled trial were used. Analyses were carried out for nivolumab monotherapy or nivolumab with ipilimumab versus ipilimumab monotherapy. The SE 1-step validation method based on a joint frailty-copula model was used where the country of enrolment was applied to define clusters. Kendall's τ and the coefficient of determination (R 2 trial ) were estimated for respective measurements of association at the individual and cluster levels. The surrogate threshold effect, the maximum threshold hazard ratio for TNT-D that would translate into OS benefit, was estimated. A leave-one-out cross-validation analysis was carried out to evaluate model robustness.
RESULTS


Fifteen clusters of data were generated from 945 patients. For both nivolumab-containing arms, the association between TNT-D and OS was deemed acceptable at the individual level (Kendall's τ > 0.60) and strong at the cluster level, with R 2 trial  fairly close to 1, with narrow confidence intervals. The estimated surrogate threshold effects were 0.61 for nivolumab versus ipilimumab and 0.49 for nivolimub + ipilimumab versus ipilimumab. Cross-validation results showed minimum variation of the correlation measures and satisfactory predictive accuracy for the model.
CONCLUSION


Results suggest that TNT-D may be a valuable SE in previously untreated advanced melanoma patients treated with immune checkpoint inhibitors. Surrogacy analyses considering multiple randomised controlled trials are warranted for confirming these findings.",2022,The estimated surrogate threshold effects were 0.61 for nivolumab versus ipilimumab and 0.49 for nivolimub + ipilimumab versus ipilimumab.,"['Fifteen clusters of data were generated from 945 patients', 'Patient-level data from the 60-month results of the CheckMate 067 randomised', 'previously untreated advanced melanoma patients', 'previously untreated advanced melanoma patients treated with immune checkpoint inhibitors', 'patients treated with immune checkpoint inhibitors', 'advanced melanoma patients treated with']","['ipilimumab', 'immune checkpoint inhibitors', 'ipilimumab versus ipilimumab monotherapy', 'TNT-D']","['overall survival (OS', 'overall survival']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",945.0,0.240228,The estimated surrogate threshold effects were 0.61 for nivolumab versus ipilimumab and 0.49 for nivolimub + ipilimumab versus ipilimumab.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Branchoux', 'Affiliation': 'Health Economics and Outcomes Research, Bristol Myers Squibb, Rueil-Malmaison, France. Electronic address: Sebastien.branchoux@bms.com.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Sofeu', 'Affiliation': 'Biostatistic Team, Bordeaux Population Health Center, ISPED, Centre INSERM U1219, INSERM, Bordeaux, France.'}, {'ForeName': 'A-F', 'Initials': 'AF', 'LastName': 'Gaudin', 'Affiliation': 'Health Economics and Outcomes Research, Bristol Myers Squibb, Rueil-Malmaison, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kurt', 'Affiliation': 'Health Economics and Outcomes Research, Bristol Myers Squibb, Princeton, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moshyk', 'Affiliation': 'Health Economics and Outcomes Research, Bristol Myers Squibb, Princeton, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Italiano', 'Affiliation': 'Department of Early Phase Trial Unit, Institut Bergonié Comprehensive Cancer Centre, Bordeaux, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bellera', 'Affiliation': 'Epicene Team (Cancer and Environment), Bordeaux Population Health Center, ISPED, Centre INSERM U1219, INSERM, Bordeaux, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Rondeau', 'Affiliation': 'Biostatistic Team, Bordeaux Population Health Center, ISPED, Centre INSERM U1219, INSERM, Bordeaux, France.'}]",ESMO open,['10.1016/j.esmoop.2021.100340']
3564,35060618,Oral antihistamine-decongestant-analgesic combinations for the common cold.,"BACKGROUND


Although combination formulas containing antihistamines, decongestants, and/or analgesics are sold over-the-counter in large quantities for the common cold, the evidence for their effectiveness is limited. This is an update of a review first published in 2012.
OBJECTIVES


To assess the effectiveness of antihistamine-decongestant-analgesic combinations compared with placebo or other active controls (excluding antibiotics) in reducing the duration of symptoms and alleviating symptoms (general feeling of illness, nasal congestion, rhinorrhoea, sneezing, and cough) in children and adults with the common cold.
SEARCH METHODS


We searched CENTRAL, MEDLINE via EBSCOhost, Embase, CINAHL via EBSCOhost, LILACS, and Web of Science to 10 June 2021. We searched the WHO ICTRP and ClinicalTrials.gov on 10 June 2021.
SELECTION CRITERIA


Randomised controlled trials investigating the effectiveness of antihistamine-decongestant-analgesic combinations compared with placebo, other active treatment (excluding antibiotics), or no treatment in children and adults with the common cold.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane. We assessed the certainty of the evidence using the GRADE approach. We categorised the included trials according to the active ingredients.
MAIN RESULTS


We identified 30 studies (6304 participants) including 31 treatment comparisons. The control intervention was placebo in 26 trials and an active substance (paracetamol, chlorphenindione + phenylpropanolamine + belladonna, diphenhydramine) in six trials (two trials had placebo as well as active treatment arms). Reporting of methods was generally poor, and there were large differences in study design, participants, interventions, and outcomes. Most of the included trials involved adult participants. Children were included in nine trials. Three trials included very young children (from six months to five years), and five trials included children aged 2 to 16. One trial included adults and children aged 12 years or older. The trials took place in different settings: university clinics, paediatric departments, family medicine departments, and general practice surgeries.  Antihistamine-decongestant: 14 trials (1298 participants). Eight trials reported on global effectiveness, of which six studies were pooled (281 participants on active treatment and 284 participants on placebo). The odds ratio (OR) of treatment failure was 0.31 (95% confidence interval (CI) 0.20 to 0.48; moderate certainty evidence); number needed to treat for an additional beneficial outcome (NNTB) 3.9 (95% CI 3.03 to 5.2). On the final evaluation day (follow-up: 3 to 10 days), 55% of participants in the placebo group had a favourable response compared to 70% on active treatment. Of the two trials not pooled, one showed some global effect, whilst the other showed no effect. Adverse effects: the antihistamine-decongestant group experienced more adverse effects than the control group: 128/419 (31%) versus 100/423 (13%) participants suffered one or more adverse effects (OR 1.58, 95%CI 0.78 to 3.21; moderate certainty of evidence). Antihistamine-analgesic: four trials (1608 participants). Two trials reported on global effectiveness; data from one trial were presented (290 participants on active treatment and 292 participants on ascorbic acid). The OR of treatment failure was 0.33 (95% CI 0.23 to 0.46; moderate certainty evidence); NNTB 6.67 (95% CI 4.76 to 12.5). Forty-three per cent of participants in the control group and 70% in the active treatment group were cured after six days of treatment. The second trial also showed an effect in favour of the active treatment. Adverse effects: there were not significantly more adverse effects in the active treatment group compared to placebo (drowsiness, hypersomnia, sleepiness  10/152 versus 4/120; OR 1.64 (95 % CI 0.48 to 5.59; low certainty evidence). Analgesic-decongestant: seven trials (2575 participants). One trial reported on global effectiveness: 73% of participants in the analgesic-decongestant group reported a benefit compared with 52% in the control group (paracetamol) (OR of treatment failure 0.28, 95% CI 0.15 to 0.52; moderate certainty evidence; NNTB 4.7). Adverse effects: the decongestant-analgesic group experienced significantly more adverse effects than the control group (199/1122 versus 75/675; OR 1.62  95% CI 1.18 to 2.23; high certainty evidence; number needed to treat for an additional harmful outcome (NNTH 17).  Antihistamine-analgesic-decongestant: six trials (1014 participants). Five trials reported on global effectiveness, of which two studies in adults could be pooled: global effect reported with active treatment (52%) and placebo (34%) was equivalent to a difference of less than one point on a four- or five-point scale; the OR of treatment failure was 0.47 (95% CI 0.33 to 0.67; low certainty evidence); NNTB 5.6 (95% CI 3.8 to 10.2). One trial in children aged 2 to 12 years, and two trials in adults found no beneficial effect. Adverse effects: in one trial 5/224 (2%) suffered adverse effects with the active treatment versus 9/208 (4%) with placebo. Two other trials reported no differences between treatment groups.
AUTHORS' CONCLUSIONS


We found a lack of data on the effectiveness of antihistamine-analgesic-decongestant combinations for the common cold. Based on these scarce data, the effect on individual symptoms is probably too small to be clinically relevant. The current evidence suggests that antihistamine-analgesic-decongestant combinations have some general benefit in adults and older children. These benefits must be weighed against the risk of adverse effects. There is no evidence of effectiveness in young children. In 2005, the US Food and Drug Administration issued a warning about adverse effects associated with the use of over-the-counter nasal preparations containing phenylpropanolamine.",2022,Adverse effects: the decongestant-analgesic group experienced significantly more adverse effects than the control group (199/1122 versus 75/675; OR 1.62  95% CI 1.18 to 2.23; high certainty evidence; number needed to treat for an additional harmful outcome (NNTH 17).  ,"['young children', '290 participants on active treatment and 292 participants on ascorbic acid', 'children aged 2 to 12 years', 'Three trials included very young children (from six months to five years), and five trials included children aged 2 to 16', 'different settings: university clinics, paediatric departments, family medicine departments, and general practice surgeries', 'adults and older children', 'adults and children aged 12 years or older', 'children and adults with the common cold', '281 participants on active treatment and 284 participants on']","['placebo', 'active substance (paracetamol, chlorphenindione + phenylpropanolamine + belladonna, diphenhydramine', 'Oral antihistamine-decongestant-analgesic combinations', 'antihistamine-decongestant', 'placebo or other active controls (excluding antibiotics', 'antihistamine-analgesic-decongestant combinations', 'control group (paracetamol', 'Antihistamine-analgesic-decongestant', 'Antihistamine-analgesic', 'Antihistamine-decongestant', 'placebo, other active treatment (excluding antibiotics', 'antihistamine-decongestant-analgesic combinations']","['duration of symptoms and alleviating symptoms (general feeling of illness, nasal congestion, rhinorrhoea, sneezing, and cough', 'placebo (drowsiness, hypersomnia, sleepiness', 'Adverse effects', 'adverse effects', 'OR of treatment failure', 'global effectiveness', 'favourable response', 'odds ratio (OR) of treatment failure']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0442593', 'cui_str': 'General practice premises'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009443', 'cui_str': 'Common cold'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1321946', 'cui_str': 'CHLORPHENINDIONE'}, {'cui': 'C0031495', 'cui_str': 'Phenylpropanolamine'}, {'cui': 'C0004953', 'cui_str': 'Atropa belladonna'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0282374', 'cui_str': 'Decongestant'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0037383', 'cui_str': 'Sneezing'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",6304.0,0.69683,Adverse effects: the decongestant-analgesic group experienced significantly more adverse effects than the control group (199/1122 versus 75/675; OR 1.62  95% CI 1.18 to 2.23; high certainty evidence; number needed to treat for an additional harmful outcome (NNTH 17).  ,"[{'ForeName': 'An Im', 'Initials': 'AI', 'LastName': 'De Sutter', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Eriksson', 'Affiliation': 'Herston Health Sciences Library, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Mieke L', 'Initials': 'ML', 'LastName': 'van Driel', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004976.pub4']
3565,35051263,Expression Profiles of Immune Cells after Propofol or Sevoflurane Anesthesia for Colorectal Cancer Surgery: A Prospective Double-blind Randomized Trial.,"BACKGROUND


The antitumor effects of natural killer cells, helper T cells, and cytotoxic T cells after cancer surgery were reported previously. This study hypothesized that propofol-based anesthesia would have fewer harmful effects on immune cells than volatile anesthetics-based anesthesia during colorectal cancer surgery.
METHODS


In total, 153 patients undergoing colorectal cancer surgery were randomized and included in the analysis. The primary outcome was the fraction of circulating natural killer cells over time in the propofol and sevoflurane groups. The fractions of circulating natural killer, type 1, type 17 helper T cells, and cytotoxic T cells were investigated. The fractions of CD39 and CD73 expressions on circulating regulatory T cells were investigated, along with the proportions of circulating neutrophils, lymphocytes, and monocytes.
RESULTS


The fraction of circulating natural killer cells was not significantly different between the propofol and sevoflurane groups until 24 h postoperatively (20.4 ± 13.4% vs. 20.8 ± 11.3%, 17.9 ± 12.7% vs. 20.7 ± 11.9%, and 18.6 ± 11.6% vs. 21.3 ± 10.8% before anesthesia and after 1 and 24 h after anesthesia, respectively; difference [95% CI], -0.3 [-4.3 to 3.6], -2.8 [-6.8 to 1.1], and -2.6 [-6.2 to 1.0]; P = 0.863, P = 0.136, and P = 0.151 before anesthesia and after 1 and 24 h, respectively). The fractions of circulating type 1 and type 17 helper T cells, cytotoxic T cells, and CD39+ and CD73+ circulating regulatory T cells were not significantly different between the two groups. The neutrophil to lymphocyte ratio in both groups remained within the normal range and was not different between the groups.
CONCLUSIONS


Propofol-based anesthesia was not superior to sevoflurane-based anesthesia in terms of alleviating suppression of immune cells including natural killer cells and T lymphocytes during colorectal cancer surgery.
EDITOR’S PERSPECTIVE


",2022,"The fraction of circulating natural killer cells was not significantly different between the propofol and sevoflurane groups until 24 h postoperatively (20.4 ± 13.4% vs. 20.8 ± 11.3%, 17.9 ± 12.7% vs. 20.7 ± 11.9%, and 18.6 ± 11.6% vs. 21.3 ± 10.8% before anesthesia and after 1 and 24 h after anesthesia, respectively; difference [95% CI], -0.3 [-4.3 to 3.6], -2.8 [-6.8 to 1.1], and -2.6 [-6.2 to 1.0]; P = 0.863, P = 0.136, and P","['153 patients undergoing colorectal cancer surgery', 'Colorectal Cancer Surgery']","['sevoflurane-based anesthesia', 'Propofol-based anesthesia', 'sevoflurane', 'propofol-based anesthesia', 'propofol', 'Sevoflurane Anesthesia', 'volatile anesthetics-based anesthesia', 'Propofol']","['neutrophil to lymphocyte ratio', 'fraction of circulating natural killer cells over time', 'fractions of circulating type 1 and type 17 helper T cells, cytotoxic T cells, and CD39+ and CD73+ circulating regulatory T cells', 'fraction of circulating natural killer cells', 'fractions of circulating natural killer, type 1, type 17 helper T cells, and cytotoxic T cells', 'fractions of CD39 and CD73 expressions on circulating regulatory T cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C2936411', 'cui_str': 'T Helper 17 Cells'}, {'cui': 'C0039195', 'cui_str': 'Cytotoxic T lymphocyte'}, {'cui': 'C0108783', 'cui_str': 'Lymphocyte antigen CD39'}, {'cui': 'C0000530', 'cui_str': ""5'-nucleotidase""}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",153.0,0.20222,"The fraction of circulating natural killer cells was not significantly different between the propofol and sevoflurane groups until 24 h postoperatively (20.4 ± 13.4% vs. 20.8 ± 11.3%, 17.9 ± 12.7% vs. 20.7 ± 11.9%, and 18.6 ± 11.6% vs. 21.3 ± 10.8% before anesthesia and after 1 and 24 h after anesthesia, respectively; difference [95% CI], -0.3 [-4.3 to 3.6], -2.8 [-6.8 to 1.1], and -2.6 [-6.2 to 1.0]; P = 0.863, P = 0.136, and P","[{'ForeName': 'Chung-Sik', 'Initials': 'CS', 'LastName': 'Oh', 'Affiliation': 'Departments of Anesthesiology and Pain Medicine, Konkuk University School of Medicine, Konkuk University Medical Center, Seoul, Korea; the Research Institute of Medical Science, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyun-Jun', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'the Korea Institute of Radiological and Medical Sciences, Seoul, Korea.'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'Piao', 'Affiliation': 'the Department of Infection and Immunology.'}, {'ForeName': 'Kyo-Min', 'Initials': 'KM', 'LastName': 'Sohn', 'Affiliation': 'Departments of Anesthesiology and Pain Medicine, Konkuk University School of Medicine, Konkuk University Medical Center, Seoul, Korea.'}, {'ForeName': 'Seong-Eun', 'Initials': 'SE', 'LastName': 'Koh', 'Affiliation': 'Rehabilitation Medicine, Konkuk University School of Medicine, Konkuk University Medical Center, Seoul, Korea; the Research Institute of Medical Science, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Dae-Yong', 'Initials': 'DY', 'LastName': 'Hwang', 'Affiliation': 'Surgery, Konkuk University School of Medicine, Konkuk University Medical Center, Seoul, Korea; the Research Institute of Medical Science, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Seong-Hyop', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Departments of Anesthesiology and Pain Medicine, Konkuk University School of Medicine, Konkuk University Medical Center, Seoul, Korea; the Department of Infection and Immunology; the Research Institute of Medical Science, Konkuk University School of Medicine, Seoul, Korea.'}]",Anesthesiology,['10.1097/ALN.0000000000004119']
3566,35063469,Transcranial direct current stimulation of the premotor cortex aimed to improve hand motor function in chronic stroke patients.,"OBJECTIVE


To investigate the effects of single-session premotor and primary motor tDCS in chronic stroke patients with relation to possible inter-hemispheric interactions.
METHODS


Anodal tDCS of either M1 or premotor cortex of the side contralateral to the paretic hand, cathodal tDCS of the premotor cortex of the side ipsilateral to the paretic hand and sham stimulation were performed in 12 chronic stroke patients with mild hand paresis in a balanced cross-over design. The Jebsen-Taylor Hand Function test, evaluating the time required for performance of everyday motor tasks, was employed.
RESULTS


The repeated-measure ANOVA with Greenhouse-Geisser correction showed significant influence of the stimulation type (factor SESSION; F(2.6, 28.4) = 47.3, p < 0.001), the test performance time relative to stimulation (during or after tDCS; factor TIME, F(1.0, 11.0) = 234.5, p < 0.001) with higher effect after the stimulation and the interaction SESSION*TIME (F(1.7, 1.2) = 30.5, p < 0.001). All active conditions were effective for the modulation of JTT performance, though the highest effect was observed after anodal tDCS of M1, followed by effects after anodal stimulation of the premotor cortex contralateral to the paretic hand. Based on the correlation patterns, the inhibitory input to M1 from premotor cortex of another hemisphere and an excitatory input from the ipsilesional premotor cortex were suggested.
CONCLUSION


The premotor cortex is a promising candidate area for transcranial non-invasive stimulation of chronic stroke patients.",2022,"All active conditions were effective for the modulation of JTT performance, though the highest effect was observed after anodal tDCS of M1, followed by effects after anodal stimulation of the premotor cortex contralateral to the paretic hand.","['chronic stroke patients', '12 chronic stroke patients with mild hand paresis in a balanced cross-over design', 'chronic stroke patients with relation to possible inter-hemispheric interactions']","['M1 or premotor cortex of the side contralateral to the paretic hand, cathodal tDCS of the premotor cortex of the side ipsilateral to the paretic hand and sham stimulation', 'single-session premotor and primary motor tDCS']",['test performance time relative to stimulation'],"[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]","[{'cui': 'C0228202', 'cui_str': 'Premotor cortex'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",12.0,0.0405137,"All active conditions were effective for the modulation of JTT performance, though the highest effect was observed after anodal tDCS of M1, followed by effects after anodal stimulation of the premotor cortex contralateral to the paretic hand.","[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Pavlova', 'Affiliation': 'Department of Clinical Sciences Karolinska Institute, Danderyd University Hospital, SE-18288 Stockholm, Sweden. Electronic address: elepav1966@gmail.com.'}, {'ForeName': 'R V', 'Initials': 'RV', 'LastName': 'Semenov', 'Affiliation': 'Moscow Research and Clinical Center for Neuropsychiatry of the Healthcare Department of Moscow, Moscow, Russia.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Pavlova-Deb', 'Affiliation': 'Institute for Bioengineering of Catalonia, Barcelona 08028, Spain.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Guekht', 'Affiliation': 'Moscow Research and Clinical Center for Neuropsychiatry of the Healthcare Department of Moscow, Moscow, Russia.'}]",Brain research,['10.1016/j.brainres.2022.147790']
3567,35039174,"Increased adherence to perioperative safety guidelines associated with improved patient safety outcomes: a stepped-wedge, cluster-randomised multicentre trial.","BACKGROUND


National Dutch guidelines have been introduced to improve suboptimal perioperative care. A multifaceted implementation programme (IMPlementatie Richtlijnen Operatieve VEiligheid [IMPROVE]) has been developed to support hospitals in applying these guidelines. This study evaluated the effectiveness of IMPROVE on guideline adherence and the association between guideline adherence and patient safety.
METHODS


Nine hospitals participated in this unblinded, superiority, stepped-wedge, cluster RCT in patients with major noncardiac surgery (mortality risk ≥1%). IMPROVE consisted of educational activities, audit and feedback, reminders, organisational, team-directed, and patient-mediated activities. The primary outcome of the study was guideline adherence measured by nine patient safety indicators on the process (stop moments from the composite STOP bundle, and timely administration of antibiotics) and on the structure of perioperative care. Secondary safety outcomes included in-hospital complications, postoperative wound infections, mortality, length of hospital stay, and unplanned care.
RESULTS


Data were analysed for 1934 patients. The IMPROVE programme improved one stop moment: 'discharge from recovery room' (+16%; 95% confidence interval [CI], 9-23%). This stop moment was related to decreased mortality (-3%; 95% CI, -4% to -1%), fewer complications (-8%; 95% CI, -13% to -3%), and fewer unscheduled transfers to the ICU (-6%; 95% CI, -9% to -3%). IMPROVE negatively affected one other stop moment - 'discharge from the hospital' - possibly because of the limited resources of hospitals to improve all stop moments together.
CONCLUSIONS


Mixed implementation effects of IMPROVE were found. We found some positive associations between guideline adherence and patient safety (i.e. mortality, complications, and unscheduled transfers to the ICU) except for the timely administration of antibiotics.
CLINICAL TRIAL REGISTRATION


NTR3568 (Dutch Trial Registry).",2022,"The IMPROVE programme improved one stop moment: 'discharge from recovery room' (+16%; 95% confidence interval [CI], 9-23%).","['Nine hospitals participated in this unblinded, superiority, stepped-wedge, cluster RCT in patients with major noncardiac surgery (mortality risk ≥1', '1934 patients']",['NTR3568'],"['patient safety outcomes', 'mortality', 'guideline adherence measured by nine patient safety indicators on the process (stop moments from the composite STOP bundle, and timely administration of antibiotics) and on the structure of perioperative care', 'fewer complications', 'hospital complications, postoperative wound infections, mortality, length of hospital stay, and unplanned care']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0525059', 'cui_str': 'Guideline Adherence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0199779', 'cui_str': 'Administration of antibiotic'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",9.0,0.289174,"The IMPROVE programme improved one stop moment: 'discharge from recovery room' (+16%; 95% confidence interval [CI], 9-23%).","[{'ForeName': 'Yvette E J J M', 'Initials': 'YEJJM', 'LastName': 'Emond', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboudumc, Nijmegen, The Netherlands; Department of Anesthesiology, Pain and Palliative Care, Radboud Institute for Health Sciences, Radboudumc, Nijmegen, The Netherlands. Electronic address: Yvette.Emond@radboudumc.nl.'}, {'ForeName': 'Hiske', 'Initials': 'H', 'LastName': 'Calsbeek', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Yvonne A S', 'Initials': 'YAS', 'LastName': 'Peters', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Gerrit J A', 'Initials': 'GJA', 'LastName': 'Bloo', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboudumc, Nijmegen, The Netherlands; Department of Anesthesiology, Pain and Palliative Care, Radboud Institute for Health Sciences, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Teerenstra', 'Affiliation': 'Department for Health Evidence, Section Biostatistics, Radboud Institute for Health Sciences, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Gert P', 'Initials': 'GP', 'LastName': 'Westert', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Damen', 'Affiliation': 'Department of Anesthesiology, Pain and Palliative Care, Radboud Institute for Health Sciences, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Hub C', 'Initials': 'HC', 'LastName': 'Wollersheim', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'André P', 'Initials': 'AP', 'LastName': 'Wolff', 'Affiliation': 'Department of Anesthesiology, Pain Center, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]",British journal of anaesthesia,['10.1016/j.bja.2021.12.019']
3568,34533489,Pharmacokinetics and Safety of Ceftobiprole in Pediatric Patients.,"BACKGROUND


Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced-generation, broad-spectrum, intravenous cephalosporin, which is currently approved for the treatment of adults with hospital-acquired or community-acquired pneumonia.
METHODS


Noncompartmental pharmacokinetics and safety were analyzed from 2 recently completed pediatric studies, a single-dose, phase 1 study in neonates and infants up to 3 months of age (7.5 mg/kg) and a phase 3 study in patients 3 months to 17 years of age with pneumonia (10-20 mg/kg with a maximum of 500 mg per dose every 8 hours for up to 14 days).
RESULTS


Total ceftobiprole plasma concentrations peaked at the end of infusion. Half life (median ranging from 1.9 to 2.9 hours) and overall exposure (median AUC ranging from 66.6 to 173 μg•h/mL) were similar to those in adults (mean ± SD, 3.3 ± 0.3 hours and 102 ± 11.9 μg•h/mL, respectively). Calculated free-ceftobiprole concentrations in the single-dose study remained above a minimum inhibitory concentration (MIC) of 4 mg/L (fT > MIC of 4 mg/L) for a mean of 5.29 hours after dosing. In the pneumonia study, mean fT > MIC of 4 mg/L was ≥5.28 hours in all dose groups. Ceftobiprole was well tolerated in both studies.
CONCLUSIONS


Pharmacokinetic parameters of ceftobiprole characterized in the pediatric population were within the range of those observed in adults. In the pneumonia study, the lowest percentage of the dosing interval with fT > MIC of 4 mg/L was 50.8%, which suggests that pharmacokinetic-pharmacodynamic target attainment can be sufficient in pediatric patients. Ceftobiprole was well tolerated.",2021,"CONCLUSIONS


Pharmacokinetic parameters of ceftobiprole characterized in the pediatric population were within the range of those observed in adults.","['pediatric patients', '2 recently completed pediatric studies, a single-dose, phase 1 study in neonates and infants up to 3 months of age (7.5 mg/kg) and a phase 3 study in patients 3 months to 17 years of age with pneumonia (10-20\u2009mg/kg with a maximum of 500\u2009mg per dose every 8 hours for up to 14 days', 'Pediatric Patients', 'adults with hospital-acquired or community-acquired pneumonia']",['Ceftobiprole'],"['Total ceftobiprole plasma concentrations', 'Calculated free-ceftobiprole concentrations', 'Half life', 'tolerated']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0920321', 'cui_str': 'Phase I Clinical Trials'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0585326', 'cui_str': 'Every eight hours'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0456393', 'cui_str': 'Hospital acquired'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}]","[{'cui': 'C1100584', 'cui_str': 'Ceftobiprole'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1100584', 'cui_str': 'Ceftobiprole'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",,0.114032,"CONCLUSIONS


Pharmacokinetic parameters of ceftobiprole characterized in the pediatric population were within the range of those observed in adults.","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Rubino', 'Affiliation': 'From the Institute for Clinical Pharmacodynamics, Inc. Schenectady, NY.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Polak', 'Affiliation': 'West Virginia University School of Medicine, Department of Pediatrics, Morgantown, WV.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schröpf', 'Affiliation': ""Dr. von Hauner Children's Hospital, Ludwig-Maximilians-University Munich, Munich, Germany.""}, {'ForeName': 'Hans Georg', 'Initials': 'HG', 'LastName': 'Münch', 'Affiliation': ""Dr. von Hauner Children's Hospital, Ludwig-Maximilians-University Munich, Munich, Germany.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Smits', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Cossey', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Tomasik', 'Affiliation': 'Jagiellonian University Medical College, Department of Pediatrics, Cracow, Poland.'}, {'ForeName': 'Przemko', 'Initials': 'P', 'LastName': 'Kwinta', 'Affiliation': 'Jagiellonian University Medical College, Department of Pediatrics, Cracow, Poland.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Snariene', 'Affiliation': 'Medical Faculty of Vilnius University, Neonatal Center of Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.'}, {'ForeName': 'Arunas', 'Initials': 'A', 'LastName': 'Liubsys', 'Affiliation': 'Medical Faculty of Vilnius University, Neonatal Center of Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.'}, {'ForeName': 'Dace', 'Initials': 'D', 'LastName': 'Gardovska', 'Affiliation': ""Children's Clinical University Hospital, Riga Stradins University, Riga, Latvia.""}, {'ForeName': 'Chi Dang', 'Initials': 'CD', 'LastName': 'Hornik', 'Affiliation': 'Duke University Hospital, Department of Pediatrics, Durham, NC.'}, {'ForeName': 'Miroslava', 'Initials': 'M', 'LastName': 'Bosheva', 'Affiliation': 'Medical University, University Multiprofile Hospital for Active Treatment ""Sveti Georgi,"" Plovdiv, Clinic of Pediatric and Genetic Diseases, Plovdiv, Bulgaria.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ruehle', 'Affiliation': 'Basilea Pharmaceutica International Ltd., Basel, Switzerland.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Litherland', 'Affiliation': 'Basilea Pharmaceutica International Ltd., Basel, Switzerland.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Hamed', 'Affiliation': 'Basilea Pharmaceutica International Ltd., Basel, Switzerland.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000003296']
3569,35038601,Predictive risk factors for hospitalization and response to colchicine in patients with COVID-19.,"OBJECTIVE


A predictive model for hospitalization due to COVID-19 or death was developed in the placebo group (N=2,084) from a large clinical trial of colchicine in COVID-19 patients (N = 4,159).
RESULTS


The 7 variables retained in the predictive model were age, gender, body-mass index, history of respiratory disease, use of diabetes drugs, use of anticoagulants, and use of oral steroids at the time of randomization. An optimal threshold value identified from the predictive model was used to classify high-risk patients (those with a predicted probability above the optimal threshold) and low-risk patients (those with a predicted probability below the optimal threshold). The number needed to treat to prevent 1 hospitalization or death with colchicine treatment decreased from 71 in the whole study population (N = 4,159) to 29 in the high-risk subgroup (N=1,692).
CONCLUSION


This model could serve to identify high-risk subjects who will particularly benefit from early colchicine therapy.",2022,"The number needed to treat to prevent one hospitalization or death with colchicine treatment decreased from 71 in the whole study population (N = 4159) to 29 in the high-risk subgroup (N=1692).
","['high-risk subjects who will particularly benefit from early colchicine therapy', 'patients with COVID-19', 'COVID-19 patients (N\u202f=\u202f4159']","['placebo', 'colchicine']",[],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}]",[],,0.066027,"The number needed to treat to prevent one hospitalization or death with colchicine treatment decreased from 71 in the whole study population (N = 4159) to 29 in the high-risk subgroup (N=1692).
","[{'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'Montreal Heart Institute and Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Mariève', 'Initials': 'M', 'LastName': 'Cossette', 'Affiliation': 'Montreal Health Innovations Coordinating Center (MHICC), Montreal, QC, Canada.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Guertin', 'Affiliation': 'Montreal Health Innovations Coordinating Center (MHICC), Montreal, QC, Canada.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Bouabdallaoui', 'Affiliation': 'Montreal Heart Institute and Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Dubé', 'Affiliation': 'Montreal Heart Institute and Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Boivin', 'Affiliation': 'Research Center in Infectious Diseases, CHU de Québec and Université Laval, Quebec City, QC, Canada. Electronic address: Guy.Boivin@crchudequebec.ulaval.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2022.01.020']
3570,35045989,Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial.,"BACKGROUND


The role of remdesivir in the treatment of patients in hospital with COVID-19 remains ill defined in a global context. The World Health Organization Solidarity randomized controlled trial (RCT) evaluated remdesivir in patients across many countries, with Canada enrolling patients using an expanded data collection format in the Canadian Treatments for COVID-19 (CATCO) trial. We report on the Canadian findings, with additional demographics, characteristics and clinical outcomes, to explore the potential for differential effects across different health care systems.
METHODS


We performed an open-label, pragmatic RCT in Canadian hospitals, in conjunction with the Solidarity trial. We randomized patients to 10 days of remdesivir (200 mg intravenously [IV] on day 0, followed by 100 mg IV daily), plus standard care, or standard care alone. The primary outcome was in-hospital mortality. Secondary outcomes included changes in clinical severity, oxygen- and ventilator-free days (at 28 d), incidence of new oxygen or mechanical ventilation use, duration of hospital stay, and adverse event rates. We performed a priori subgroup analyses according to duration of symptoms before enrolment, age, sex and severity of symptoms on presentation.
RESULTS


Across 52 Canadian hospitals, we randomized 1282 patients between Aug. 14, 2020, and Apr. 1, 2021, to remdesivir ( n  = 634) or standard of care ( n  = 648). Of these, 15 withdrew consent or were still in hospital, for a total sample of 1267 patients. Among patients assigned to receive remdesivir, in-hospital mortality was 18.7%, compared with 22.6% in the standard-of-care arm (relative risk [RR] 0.83 (95% confidence interval [CI] 0.67 to 1.03), and 60-day mortality was 24.8% and 28.2%, respectively (95% CI 0.72 to 1.07). For patients not mechanically ventilated at baseline, the need for mechanical ventilation was 8.0% in those assigned remdesivir, and 15.0% in those receiving standard of care (RR 0.53, 95% CI 0.38 to 0.75). Mean oxygen-free and ventilator-free days at day 28 were 15.9 (± standard deviation [SD] 10.5) and 21.4 (± SD 11.3) in those receiving remdesivir and 14.2 (± SD 11) and 19.5 (± SD 12.3) in those receiving standard of care ( p  = 0.006 and 0.007, respectively). There was no difference in safety events of new dialysis, change in creatinine, or new hepatic dysfunction between the 2 groups.
INTERPRETATION


Remdesivir, when compared with standard of care, has a modest but significant effect on outcomes important to patients and health systems, such as the need for mechanical ventilation.  Trial registration : ClinicalTrials.gov, no. NCT04330690.",2022,"There was no difference in safety events of new dialysis, change in creatinine, or new hepatic dysfunction between the 2 groups.
","['15 withdrew consent or were still in hospital, for a total sample of 1267 patients', 'patients across many countries, with Canada enrolling patients using an expanded data collection format in the Canadian Treatments for COVID-19 (CATCO) trial', 'patients in hospital with COVID-19 remains ill defined in a global context', '52 Canadian hospitals, we randomized 1282 patients between Aug. 14, 2020, and Apr. 1, 2021, to remdesivir ( n  = 634) or standard of care ( n  = 648', 'patients in hospital with COVID-19 in Canada']","['plus standard care, or standard care alone', 'remdesivir']","['hospital mortality', '60-day mortality', 'mechanical ventilation', 'safety events of new dialysis, change in creatinine, or new hepatic dysfunction', 'Mean oxygen-free and ventilator-free days', 'changes in clinical severity, oxygen- and ventilator-free days (at 28 d), incidence of new oxygen or mechanical ventilation use, duration of hospital stay, and adverse event rates']","[{'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1282.0,0.534748,"There was no difference in safety events of new dialysis, change in creatinine, or new hepatic dysfunction between the 2 groups.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne,['10.1503/cmaj.211698']
3571,35057905,Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT.,"BACKGROUND


Bacterial vaginosis is a common and distressing condition associated with serious comorbidities. Antibiotic treatment is usually clinically effective in the short term, but recurrence is common and side effects can occur.
OBJECTIVES


The objective is to assess whether or not intravaginal lactic acid gel is clinically effective and cost-effective for treating recurrent bacterial vaginosis compared with oral metronidazole (Flagyl, Sanofi).
DESIGN


This was an open-label, multicentre, parallel-arm, randomised (1 : 1) controlled trial.
SETTING


This took place in one general practice and 19 sexual health centres in the UK.
PARTICIPANTS


Women aged ≥ 16 years with bacterial vaginosis symptoms and one or more episode(s) within the past 2 years took part.
INTERVENTIONS


The interventions were 5 ml of intravaginal lactic acid gel taken once daily for 7 days (intervention) or 400-mg oral metronidazole tablets taken twice daily for 7 days (control).
MAIN OUTCOME MEASURES


The primary outcome was the resolution of bacterial vaginosis symptoms 14 days after randomisation. The secondary outcomes were time to first recurrence of symptoms; number of recurrences and treatment courses over 6 months; microbiological resolution on microscopy of vaginal smears at week 2; time to resolution of symptoms; tolerability, adherence and acceptability of the treatment; prevalence of concurrent sexually transmitted infections; quality of life; and cost-effectiveness.
RESULTS


Recruitment stopped prior to reaching the target of 1900 participants on recommendation from the Data Monitoring Committee and Trial Steering Committee after a planned review of the results indicated that the research question had been answered. Overall, 518 participants were randomised and primary outcome data were available for 409 participants (79%; 204 in the metronidazole arm, 205 in the lactic acid gel arm). Participant-reported symptom resolution at week 2 was higher with metronidazole (143/204; 70%) than with lactic acid gel (97/205; 47%) (adjusted risk difference -23.2%, 95% confidence interval -32.3% to -14.0%). Recurrence in 6 months in a subset of participants who had initial resolution and were available for follow-up was similar across arms (metronidazole arm: 51/72, 71%; lactic acid gel arm: 32/46, 70%). A higher incidence of some side effects was reported with metronidazole than with lactic acid gel (nausea 32% vs. 8%; taste changes 18% vs. 1%; diarrhoea 20% vs. 6%, respectively). At week 2, the average cost per participant with resolved symptoms was £86.94 (metronidazole), compared with £147.00 (lactic acid gel). Some participants preferred using lactic acid gel even if they perceived it to be less effective than metronidazole.
LIMITATIONS


Loss to follow-up for collection of the primary outcome data was 21% and was similar in both arms. There is a risk of bias owing to missing outcome data at 3 and 6 months post treatment.
CONCLUSIONS


A higher initial response was seen with metronidazole than with lactic acid gel, but subsequent treatment failure was common with both. Lactic acid gel was less cost-effective than metronidazole. In general, women disliked taking repeated courses of metronidazole and preferred lactic acid gel, even when they were aware that it was less likely to provide symptom resolution. In the absence of effective curative therapy, further evaluation of non-antibiotic treatments to control the symptoms of recurrent bacterial vaginosis is required to improve quality of life for these patients. Further microbiological analysis of vaginal samples would be useful to identify additional factors affecting response to treatment.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN14161293.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 26, No. 2. See the NIHR Journals Library website for further project information.",2022,"A higher incidence of some side effects was reported with metronidazole than with lactic acid gel (nausea 32% vs. 8%; taste changes 18% vs. 1%; diarrhoea 20% vs. 6%, respectively).","['19 sexual health centres in the UK', '518 participants were randomised and primary outcome data were available for 409 participants (79%; 204 in the metronidazole arm, 205 in the lactic acid gel arm', 'women aged 16 years and over: the VITA RCT', 'Women aged ≥\u200916 years with bacterial vaginosis symptoms and one or more episode(s) within the past 2 years took part']","['intravaginal lactic acid gel', 'intravaginal lactic acid gel taken once daily for 7 days (intervention) or 400-mg oral metronidazole tablets', 'metronidazole and preferred lactic acid gel', 'Antibiotic treatment', 'metronidazole', 'Lactic acid gel', 'Lactic acid gel versus metronidazole', 'lactic acid gel']","['Recurrence', 'time to first recurrence of symptoms; number of recurrences and treatment courses over 6 months; microbiological resolution on microscopy of vaginal smears at week 2; time to resolution of symptoms; tolerability, adherence and acceptability of the treatment; prevalence of concurrent sexually transmitted infections; quality of life; and cost-effectiveness', 'quality of life', 'average cost per participant with resolved symptoms', 'resolution of bacterial vaginosis symptoms', 'symptom resolution']","[{'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0373745', 'cui_str': 'Vitamin A measurement'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0360345', 'cui_str': 'Metronidazole-containing product in oral dose form'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}]",518.0,0.230269,"A higher incidence of some side effects was reported with metronidazole than with lactic acid gel (nausea 32% vs. 8%; taste changes 18% vs. 1%; diarrhoea 20% vs. 6%, respectively).","[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Armstrong-Buisseret', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Brittain', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Kai', 'Affiliation': 'Division of Primary Care, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Miruna', 'Initials': 'M', 'LastName': 'David', 'Affiliation': 'Clinical Microbiology, Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Anstey Watkins', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Ozolins', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jackson', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Abdali', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Hepburn', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Griffiths', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Montgomery', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Manley', 'Affiliation': 'Department of Genitourinary Medicine, Whittall Street Clinic, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Dean', 'Affiliation': 'Elton John Research Centre, Brighton, UK.'}, {'ForeName': 'Jonathan Dc', 'Initials': 'JD', 'LastName': 'Ross', 'Affiliation': 'Department of Genitourinary Medicine, Whittall Street Clinic, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/ZZKH4176']
3572,35051971,"In Patients With Functional Movement Disorders, Is Specialized Physical Therapy Effective in Improving Motor Symptoms?: A Critically Appraised Topic.","BACKGROUND


Functional movement disorders (FMD, aka psychogenic movement disorders) are very common and frequently chronic and disabling. Despite this, there is a paucity of evidence-based treatment to manage and alleviate these conditions. Specialized physical therapy (PT), involving sequential motor relearning and redirecting attention, has shown promise as a therapeutic intervention for motor symptoms.
METHODS


The objective of this study was to critically assess current evidence regarding specialized PT compared with usual care in improving motor symptoms among patients with FMD. This was addressed through the development of a structured critically appraised topic. This included a clinical scenario with a clinical question, literature search strategy, critical appraisal, results, evidence summary, commentary, and bottom-line conclusions. Participants included consultant and resident neurologists, a medical librarian, and content experts in the fields of physical medicine and rehabilitation, physical and occupational therapy, psychiatry, and psychology.
RESULTS


A randomized controlled feasibility trial was identified and selected for critical appraisal. This study randomized 60 patients with FMD to a 5-day specialized outpatient PT program or to general outpatient PT referral, and measured patient-reported and clinician-measured outcomes. At 6 months, 72% of patients in the intervention group had a good outcome compared with 18% of control group patients. Patients in the specialized outpatient PT program had significantly better outcomes in 3 Short-Form 36 (SF36) domains (d=0.46 to 0.79) and multiple other scales of physical and social function as well as clinician-measured outcomes. The intervention resulted in 0.08 additional quality-adjusted life years in a cost-effective manner.
CONCLUSIONS


Current evidence suggests that in patients with FMD, specialized PT improves motor symptoms in a clinically significant, sustained, and cost-effective manner. This promising intervention warrants further investigation and replication.",2022,"At 6 months, 72% of patients in the intervention group had a good outcome compared with 18% of control group patients.","['Patients With Functional Movement Disorders', 'Participants included consultant and resident neurologists, a medical librarian, and content experts in the fields of physical medicine and rehabilitation, physical and occupational therapy, psychiatry, and psychology', '60 patients with FMD to a 5-day specialized outpatient PT program or to general outpatient PT referral, and measured patient-reported and clinician-measured outcomes', 'patients with FMD']",['Specialized physical therapy (PT'],"['3 Short-Form 36 (SF36) domains', 'motor symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4273557', 'cui_str': 'Functional movement disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0237426', 'cui_str': 'Neurologist'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0079695', 'cui_str': 'Librarian'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}]",60.0,0.0321401,"At 6 months, 72% of patients in the intervention group had a good outcome compared with 18% of control group patients.","[{'ForeName': 'Marcus N', 'Initials': 'MN', 'LastName': 'Callister', 'Affiliation': 'Departments of Neurology.'}, {'ForeName': 'Cynthia B', 'Initials': 'CB', 'LastName': 'Stonnington', 'Affiliation': 'Psychiatry and Psychology.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuc', 'Affiliation': 'Psychiatry and Psychology.'}, {'ForeName': 'Sally B', 'Initials': 'SB', 'LastName': 'Alcott', 'Affiliation': 'Physical Medicine.'}, {'ForeName': 'Erika D', 'Initials': 'ED', 'LastName': 'Driver-Dunckley', 'Affiliation': 'Departments of Neurology.'}, {'ForeName': 'Shyamal H', 'Initials': 'SH', 'LastName': 'Mehta', 'Affiliation': 'Departments of Neurology.'}, {'ForeName': 'Shemonti', 'Initials': 'S', 'LastName': 'Hasan', 'Affiliation': 'Departments of Neurology.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Marks', 'Affiliation': 'Library Services, Mayo Clinic Arizona, Scottsdale, AZ.'}, {'ForeName': 'Dean M', 'Initials': 'DM', 'LastName': 'Wingerchuk', 'Affiliation': 'Departments of Neurology.'}, {'ForeName': 'Cumara B', 'Initials': 'CB', 'LastName': ""O'Carroll"", 'Affiliation': 'Departments of Neurology.'}]",The neurologist,['10.1097/NRL.0000000000000408']
3573,35032698,"A commentary on ""Feasibility of a novel mixed-nutrient supplement in a multimodal prehabilitation intervention for lung cancer patients awaiting surgery: A randomized controlled pilot trial"" [Int. J. Surg. (2021) 93 106079].",,2022,,['lung cancer patients awaiting surgery'],"['multimodal prehabilitation intervention', 'novel mixed-nutrient supplement']",[],"[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]",[],,0.173653,,"[{'ForeName': 'Chengwei', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Hospital of Medical School of Ningbo University, Zhejiang, 315020, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Fang', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Hospital of Medical School of Ningbo University, Zhejiang, 315020, China. Electronic address: ioxsz36@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2022.106230']
3574,35041742,Interscalene Brachial Plexus Block with Liposomal Bupivacaine versus Standard Bupivacaine with Perineural Dexamethasone: A Noninferiority Trial.,"BACKGROUND


The interscalene nerve block provides analgesia for shoulder surgery. To extend block duration, provide adequate analgesia, and minimize opioid consumption, the use of adjuvants such as dexamethasone as well as the application of perineural liposomal bupivacaine have been proposed. This randomized, double-blinded, noninferiority trial hypothesized that perineural liposomal bupivacaine is noninferior to standard bupivacaine with perineural dexamethasone in respect to average pain scores in the first 72 h after surgery.
METHODS


A total of 112 patients undergoing ambulatory shoulder surgery were randomized into two groups. The liposomal bupivacaine group received a 15-ml premixed admixture of 10 ml of 133 mg liposomal bupivacaine and 5 ml of 0.5% bupivacaine (n = 55), while the bupivacaine with dexamethasone group received an admixture of 15 ml of 0.5% standard bupivacaine with 4 mg dexamethasone (n = 56), respectively. The primary outcome was the average numerical rating scale pain scores at rest over 72 h. The mean difference between the two groups was compared against a noninferiority margin of 1.3. Secondary outcomes were analgesic block duration, motor and sensory resolution, opioid consumption, numerical rating scale pain scores at rest and movement on postoperative days 1 to 4 and again on postoperative day 7, patient satisfaction, readiness for postanesthesia care unit discharge, and adverse events.
RESULTS


A liposomal bupivacaine group average numerical rating scale pain score over 72 h was not inferior to the bupivacaine with dexamethasone group (mean [SD], 2.4 [1.9] vs. 3.4 [1.9]; mean difference [95% CI], -1.1 [-1.8, -0.4]; P < 0.001 for noninferiority). There was no significant difference in duration of analgesia between the groups (26 [20, 42] h vs. 27 [20, 39] h; P = 0.851). Motor and sensory resolutions were similar in both groups: 27 (21, 48) h versus 27 (19, 40) h (P = 0.436) and 27 [21, 44] h versus 31 (20, 42) h (P = 0.862), respectively. There was no difference in opioid consumption, readiness for postanesthesia care unit discharge, or adverse events.
CONCLUSIONS


Interscalene nerve blocks with perineural liposomal bupivacaine provided effective analgesia similar to the perineural standard bupivacaine with dexamethasone. The results show that bupivacaine with dexamethasone can be used interchangeably with liposomal bupivacaine for analgesia after shoulder surgery.
EDITOR’S PERSPECTIVE


",2022,"A liposomal bupivacaine group average numerical rating scale pain score over 72 h was not inferior to the bupivacaine with dexamethasone group (mean [SD], 2.4 [1.9] vs. 3.4 [1.9]; mean difference [95% CI], -1.1 [-1.8, -0.4]; P < 0.001 for noninferiority).","['112 patients undergoing ambulatory shoulder surgery', 'shoulder surgery', 'the first 72 h after surgery']","['dexamethasone', 'bupivacaine with dexamethasone', 'liposomal bupivacaine', 'bupivacaine with perineural dexamethasone', 'Liposomal Bupivacaine', 'Bupivacaine with Perineural Dexamethasone', '15-ml premixed admixture of 10 ml of 133 mg liposomal bupivacaine and 5 ml of 0.5% bupivacaine', 'perineural liposomal bupivacaine', 'bupivacaine', 'admixture of 15 ml of 0.5% standard bupivacaine']","['average numerical rating scale pain scores', 'duration of analgesia', 'Motor and sensory resolutions', 'average pain scores', 'analgesic block duration, motor and sensory resolution, opioid consumption, numerical rating scale pain scores at rest and movement on postoperative days 1 to 4 and again on postoperative day 7, patient satisfaction, readiness for postanesthesia care unit discharge, and adverse events', 'numerical rating scale pain score', 'opioid consumption, readiness for postanesthesia care unit discharge, or adverse events']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",112.0,0.690236,"A liposomal bupivacaine group average numerical rating scale pain score over 72 h was not inferior to the bupivacaine with dexamethasone group (mean [SD], 2.4 [1.9] vs. 3.4 [1.9]; mean difference [95% CI], -1.1 [-1.8, -0.4]; P < 0.001 for noninferiority).","[{'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Jiabin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Beathe', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Wetmore', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Sang J', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Haskins', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Garvin', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Oxendine', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Ho', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Answorth A', 'Initials': 'AA', 'LastName': 'Allen', 'Affiliation': 'the Department of Orthopedics, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Popovic', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Ejiro', 'Initials': 'E', 'LastName': 'Gbaje', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Stavros G', 'Initials': 'SG', 'LastName': 'Memtsoudis', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York.'}]",Anesthesiology,['10.1097/ALN.0000000000004111']
3575,35042007,Bone Marrow Aspirate Concentrate Augmentation May Accelerate Allograft Ligamentization in Anterior Cruciate Ligament Reconstruction: A Double-Blinded Randomized Controlled Trial.,"PURPOSE


To assess the effect of bone marrow aspiration concentrate (BMAC) augmentation on clinical outcomes and magnetic resonance imaging (MRI) findings in anterior cruciate ligament (ACL) reconstruction (ACLR) with bone-patellar tendon-bone (BTB) allografts.
METHODS


A double-blinded, randomized controlled trial was conducted on 80 patients undergoing ACL reconstruction using BTB allografts. Patients were randomized to 2 groups: (1) bone marrow aspirate was collected from the iliac crest, concentrated, and approximately 2.5 mL was injected into the BTB allograft, or (2) a small sham incision was made at the iliac crest (control). MRI was performed at 3 months and 9 months postoperatively to determine the signal intensity ratio of the ACL graft.
RESULTS


Seventy-three patients were available for follow-up at 1-year postoperatively (36 BMAC, 37 control). International Knee Documentation Committee (IKDC) scores were significantly greater in the BMAC group versus the control at the 9-month postoperative period (81.6 ± 10.5 vs 74.6 ± 14.2, P = .048). There was no significant difference in the proportion of patients who met the minimal clinically important difference for IKDC between the BMAC and control groups at 9 months (89% vs 85%; P = .7). Three months postoperatively, signal intensity ratio of the inferior third of the ACL graft was significantly greater in the BMAC group versus the control group (3.2 ± 2.2 vs 2.1 ± 1.5; P = .02).
CONCLUSIONS


Patients who received BMAC augmentation of the BTB allograft during ACL reconstruction demonstrated greater signal intensity scores on MRI at 3 months, suggesting increased metabolic activity and remodeling, and potentially accelerated ligamentization. Additionally, patients in the BMAC group had greater patient-reported outcomes (IKDC) at 9 months postoperatively when compared with those who underwent a standard surgical procedure. There was no significant difference in the proportion of patients who met the minimal clinically important difference for IKDC between the BMAC and control groups at 9 months, suggesting limited clinical significance at this time point.
LEVEL OF EVIDENCE


I, randomized control trial.",2022,"IKDC scores were significantly higher in the BMAC group versus the control at the nine-month post-operative period (81.6±10.5 vs 74.6±14.2, p=0.048).","['80 patients undergoing ACLR using BTB allografts', 'Anterior Cruciate Ligament Reconstruction', 'anterior cruciate ligament reconstruction (ACLR']","['bone marrow aspirate (BMA', 'bone-patellar tendon-bone (BTB) allografts', 'bone marrow aspiration concentrate (BMAC) augmentation', 'Magnetic resonance imaging (MRI', 'Bone Marrow Aspirate Concentrate Augmentation', 'BMAC']","['IKDC scores', 'higher patient-reported outcomes (IKDC', 'signal intensity ratio (SIR) of the anterior cruciate ligament (ACL) graft', 'SIR of the inferior third of the ACL graft', 'signal intensity scores', 'metabolic activity and remodeling, and potentially accelerated ligamentization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0407564', 'cui_str': 'Allogeneic bone graft'}]","[{'cui': 'C0857285', 'cui_str': 'Bone marrow aspirate'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0398523', 'cui_str': 'Bone marrow aspiration procedure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",80.0,0.32465,"IKDC scores were significantly higher in the BMAC group versus the control at the nine-month post-operative period (81.6±10.5 vs 74.6±14.2, p=0.048).","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Forsythe', 'Affiliation': 'Department of Sports Medicine, Midwest Orthopaedics at Rush, Chicago, Illinois, U.S.A.. Electronic address: brian.forsythe@rushortho.com.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Chahla', 'Affiliation': 'Department of Sports Medicine, Midwest Orthopaedics at Rush, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Avinaash', 'Initials': 'A', 'LastName': 'Korrapati', 'Affiliation': 'Department of Sports Medicine, Midwest Orthopaedics at Rush, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Ophelie', 'Initials': 'O', 'LastName': 'Lavoie-Gagne', 'Affiliation': 'Department of Orthopaedic Surgery, Massachusetts General Hospital, Boston, Massachusetts, U.S.A.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Forlenza', 'Affiliation': 'Department of Sports Medicine, Midwest Orthopaedics at Rush, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Connor C', 'Initials': 'CC', 'LastName': 'Diaz', 'Affiliation': 'Department of Sports Medicine, Midwest Orthopaedics at Rush, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Chung', 'Affiliation': 'Department of Radiology, University of California, San Diego, California, U.S.A.'}, {'ForeName': 'Won C', 'Initials': 'WC', 'LastName': 'Bae', 'Affiliation': 'Department of Radiology, University of California, San Diego, California, U.S.A.'}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Bach', 'Affiliation': 'Department of Sports Medicine, Midwest Orthopaedics at Rush, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Cole', 'Affiliation': 'Department of Sports Medicine, Midwest Orthopaedics at Rush, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Adam B', 'Initials': 'AB', 'LastName': 'Yanke', 'Affiliation': 'Department of Sports Medicine, Midwest Orthopaedics at Rush, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Nikhil N', 'Initials': 'NN', 'LastName': 'Verma', 'Affiliation': 'Department of Sports Medicine, Midwest Orthopaedics at Rush, Chicago, Illinois, U.S.A.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2022.01.010']
3576,35040014,Meditation and Aerobic Exercise Enhance Mental Health Outcomes and Pattern Separation Learning Without Changing Heart Rate Variability in Women with HIV.,"Mental and physical (MAP) training targets the brain and the body through a combination of focused-attention meditation and aerobic exercise. The following feasibility pilot study tested whether 6 weeks of MAP training improves mental health outcomes, while enhancing discrimination learning and heart rate variability (HRV) in a group of women living with human immunodeficiency virus (HIV) and other stress-related conditions. Participants were assigned to training (n = 18) or no-training control (n = 8) groups depending on their ability and willingness to participate, and if their schedule allowed. Training sessions were held once a week for 6 weeks with 30 min of meditation followed by 30 min of aerobic exercise. Before and after 6 weeks of training, participants completed the Behavioral Pattern Separation Task as a measure of discrimination learning, self-report questionnaires of ruminative and trauma-related thoughts, depression, anxiety, and perceived stress, and an assessment of HRV at rest. After training, participants reported fewer ruminative and trauma-related thoughts, fewer depressive and anxiety symptoms, and less perceived stress (p's < 0.05). The positive impact on ruminative thoughts and depressive symptoms persisted 6 months after training. They also demonstrated enhanced discrimination of similar patterns of information (p < 0.05). HRV did not change after training (p > 0.05). Combining mental and physical training is an effective program for enhancing mental health and aspects of cognition in women living with HIV, although not necessarily through variance in heart rate.",2022,"Combining mental and physical training is an effective program for enhancing mental health and aspects of cognition in women living with HIV, although not necessarily through variance in heart rate.","['women living with human immunodeficiency virus (HIV) and other stress-related conditions', 'Women with HIV', 'women living with HIV']","['30\xa0min of meditation followed by 30\xa0min of aerobic exercise', 'no-training control', 'Meditation and Aerobic Exercise', 'MAP training', 'Combining mental and physical training', 'Mental and physical (MAP) training targets the brain and the body through a combination of focused-attention meditation and aerobic exercise']","['mental health outcomes', 'discrimination learning, self-report questionnaires of ruminative and trauma-related thoughts, depression, anxiety, and perceived stress', 'ruminative thoughts and depressive symptoms', 'ruminative and trauma-related thoughts, fewer depressive and anxiety symptoms', 'HRV', 'discrimination learning and heart rate variability (HRV']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0589098', 'cui_str': 'Focused attention'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012633', 'cui_str': 'Discrimination Learning'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0103349,"Combining mental and physical training is an effective program for enhancing mental health and aspects of cognition in women living with HIV, although not necessarily through variance in heart rate.","[{'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Millon', 'Affiliation': 'Behavioral and Systems Neuroscience, Department of Psychology, Rutgers University, Piscataway, New Jersey, USA. emma.millon@nyspi.columbia.edu.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Lehrer', 'Affiliation': 'Department of Psychiatry, Rutgers-Robert Wood Johnson Medical School, Piscataway, New Jersey, USA.'}, {'ForeName': 'Tracey J', 'Initials': 'TJ', 'LastName': 'Shors', 'Affiliation': 'Behavioral and Systems Neuroscience, Department of Psychology, Rutgers University, Piscataway, New Jersey, USA.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-021-09530-2']
3577,35039595,"Neuronally-enriched exosomal microRNA-27b mediates acute effects of ibuprofen on reward-related brain activity in healthy adults: a randomized, placebo-controlled, double-blind trial.","This double-blind, randomized, within-subjects design evaluated whether acute administration of an anti-inflammatory drug modulates neuron-specific, inflammation-modulating microRNAs linked to macroscopic changes in reward processing. Twenty healthy subjects (10 females, 10 males) underwent a functional magnetic resonance imaging scan while performing a monetary incentive delay (MID) task and provided blood samples after administration of placebo, 200 mg, or 600 mg of ibuprofen. Neuronally-enriched exosomal microRNAs were extracted from serum and sequenced. Results showed that: (1) 600 mg of ibuprofen exhibited higher miR-27b-3p, miR-320b, miR-23b and miR-203a-3p expression than placebo; (2) higher mir-27b-3p was associated with lower insula activation during MID loss anticipation; and (3) there was an inverse relationship between miR-27b-3p and MID gain anticipation in bilateral putamen during placebo, a pattern attenuated by both 200 mg and 600 mg of ibuprofen. These findings are consistent with the hypothesis that miR-27b could be an important messaging molecule that is associated with regulating the processing of positive or negative valenced information.",2022,"Results showed that: (1) 600 mg of ibuprofen exhibited higher miR-27b-3p, miR-320b, miR-23b and miR-203a-3p expression than placebo; (2) higher mir-27b-3p was associated with lower insula activation during MID loss anticipation; and (3) there was an inverse relationship between miR-27b-3p and MID gain anticipation in bilateral putamen during placebo, a pattern attenuated by both 200 mg and 600 mg of ibuprofen.","['healthy adults', 'Twenty healthy subjects (10 females, 10 males']","['ibuprofen', 'placebo', 'functional magnetic resonance imaging scan while performing a monetary incentive delay (MID) task and provided blood samples after administration of placebo, 200\xa0mg, or 600\xa0mg of ibuprofen']","['miR-27b-3p, miR-320b, miR-23b and miR-203a-3p expression']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",20.0,0.259266,"Results showed that: (1) 600 mg of ibuprofen exhibited higher miR-27b-3p, miR-320b, miR-23b and miR-203a-3p expression than placebo; (2) higher mir-27b-3p was associated with lower insula activation during MID loss anticipation; and (3) there was an inverse relationship between miR-27b-3p and MID gain anticipation in bilateral putamen during placebo, a pattern attenuated by both 200 mg and 600 mg of ibuprofen.","[{'ForeName': 'Kaiping', 'Initials': 'K', 'LastName': 'Burrows', 'Affiliation': 'Laureate Institute for Brain Research, 6655 South Yale Ave, Tulsa, OK, 74136, USA. kburrows@laureateinstitute.org.'}, {'ForeName': 'Leandra K', 'Initials': 'LK', 'LastName': 'Figueroa-Hall', 'Affiliation': 'Laureate Institute for Brain Research, 6655 South Yale Ave, Tulsa, OK, 74136, USA.'}, {'ForeName': 'Rayus', 'Initials': 'R', 'LastName': 'Kuplicki', 'Affiliation': 'Laureate Institute for Brain Research, 6655 South Yale Ave, Tulsa, OK, 74136, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Stewart', 'Affiliation': 'Laureate Institute for Brain Research, 6655 South Yale Ave, Tulsa, OK, 74136, USA.'}, {'ForeName': 'Ahlam M', 'Initials': 'AM', 'LastName': 'Alarbi', 'Affiliation': 'Departments of Surgery and Psychiatry, School of Community Medicine, The University of Oklahoma, Tulsa, OK, USA.'}, {'ForeName': 'Rajagopal', 'Initials': 'R', 'LastName': 'Ramesh', 'Affiliation': 'Department of Pathology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Savitz', 'Affiliation': 'Laureate Institute for Brain Research, 6655 South Yale Ave, Tulsa, OK, 74136, USA.'}, {'ForeName': 'T Kent', 'Initials': 'TK', 'LastName': 'Teague', 'Affiliation': 'Departments of Surgery and Psychiatry, School of Community Medicine, The University of Oklahoma, Tulsa, OK, USA.'}, {'ForeName': 'Victoria B', 'Initials': 'VB', 'LastName': 'Risbrough', 'Affiliation': 'Center of Excellence for Stress and Mental Health, La Jolla, CA, USA.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Paulus', 'Affiliation': 'Laureate Institute for Brain Research, 6655 South Yale Ave, Tulsa, OK, 74136, USA.'}]",Scientific reports,['10.1038/s41598-022-04875-y']
3578,35039529,A randomized controlled trial of stem cell injection for tendon tear.,"Tendons have limited reparative ability and perform a relatively simple mechanical function via the extracellular matrix. Thus, the injured tendon might be treated successfully by stem cell transplantation. We performed a randomized, controlled study to investigate the effects of mesenchymal stem cell injection for treating partial tears in the supraspinatus tendon. We enrolled 24 patients with shoulder pain lasting more than 3 months and partial tears in the supraspinatus tendon. Participants were assigned to three groups: stem cells in fibrin glue, normal saline/fibrin glue mixture, and normal saline only, with which intra-lesional injection was performed. Pain at activity and rest, shoulder function and tear size were evaluated. For safety measures, laboratory tests were taken and adverse events were recorded at every visit. Participants were followed up at 6, 12 weeks, 6, 12 months and 2 years after injection. The primary outcome measure was the improvement in pain at activity at 3 months after injection. Twenty-three patients were included in the final analysis. Primary outcome did not differ among groups (p = 0.35). A mixed effect model revealed no statistically significant interactions. Only time significantly predicted the outcome measure. All participants reported transient pain at the injection site. There were no differences in post-injection pain duration or severity. Safety measures did not differ between groups, and there were no persistent adverse events. Stem cell injection into supraspinatus partial tears in patients with shoulder pain lasting more than 3 months was not more effective than control injections.ClinicalTrials.gov Identifier: NCT02298023.",2022,Stem cell injection into supraspinatus partial tears in patients with shoulder pain lasting more than 3 months was not more effective than control injections.,"['Twenty-three patients were included in the final analysis', '24 patients with shoulder pain lasting more than 3\xa0months and partial tears in the supraspinatus tendon']","['stem cells in fibrin glue, normal saline/fibrin glue mixture, and normal saline only, with which intra-lesional injection', 'Stem cell injection', 'stem cell injection', 'mesenchymal stem cell injection']","['Pain at activity and rest, shoulder function and tear size', 'transient pain', 'pain at activity', 'post-injection pain duration or severity', 'Safety measures']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0443274', 'cui_str': 'Partial tear'}, {'cui': 'C0224868', 'cui_str': 'Structure of tendon of supraspinatus muscle'}]","[{'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",24.0,0.349737,Stem cell injection into supraspinatus partial tears in patients with shoulder pain lasting more than 3 months was not more effective than control injections.,"[{'ForeName': 'Se-Woong', 'Initials': 'SW', 'LastName': 'Chun', 'Affiliation': 'Department of Rehabilitation Medicine, Gyeongsang National University Changwon Hospital, Gyeongsang National University College of Medicine, Changwon, Gyeongsangnam-do, Republic of Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Yoon', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Chai-Young', 'Initials': 'CY', 'LastName': 'Lim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Keewon', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, College of Medicine, Seoul National University, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, Republic of Korea.'}, {'ForeName': 'Jeong-Gil', 'Initials': 'JG', 'LastName': 'Kim', 'Affiliation': 'Armed Forces Daejeon Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Chul-Hyun', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Hwan', 'Initials': 'SH', 'LastName': 'Hong', 'Affiliation': 'Department of Radiology, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hye Jin', 'Initials': 'HJ', 'LastName': 'Yoo', 'Affiliation': 'Department of Radiology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sun G', 'Initials': 'SG', 'LastName': 'Chung', 'Affiliation': 'Department of Rehabilitation Medicine, College of Medicine, Seoul National University, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, Republic of Korea. suncg@snu.ac.kr.'}]",Scientific reports,['10.1038/s41598-021-04656-z']
3579,35050397,Effects of Cough Training and Inspiratory Muscle Training on Cough Strength in Older Adults: A Randomized Controlled Trial.,"PURPOSE


While the need for preventive strategies to reduce the incidence of aspiration pneumonia has been indicated, it is also important to investigate effective training methods to improve cough function, which is associated with the development of aspiration pneumonia. This study aimed to investigate whether a 4-week home-based unsupervised cough training (CT) or inspiratory muscle training (IMT) program was effective in improving cough strength in older adults.
METHODS


Fifty-three ambulatory older adults without airflow limitations were randomly assigned to one of three groups: a CT group (n = 18), an IMT group (n = 18), or a control group (n = 17). The CT and IMT groups performed home-based unsupervised training with a device for 4 weeks. Cough strength (cough peak flow), forced vital capacity, and respiratory muscle strength were assessed at the 4-week and 16-week follow-up. Intention-to-treat analyses were performed to investigate differences between the three groups using linear mixed models.
RESULTS


At the 4-week follow-up, the CT group showed significant increases in cough peak flow and forced vital capacity compared with the control group, while the IMT group showed significant increases in inspiratory muscle strength compared with the cough training and control groups. At the 16-week follow-up, the CT group showed a significant increase in cough peak flow compared with the IMT group.
CONCLUSION


These preliminary results suggest that a 4-week home-based CT program may have short-term effectiveness in improving cough peak flow in ambulatory older adults.
TRIAL REGISTRATION


This trial was registered on UMIN-CTR on 01/05/2018 (UMIN000031656).",2022,"At the 4-week follow-up, the CT group showed significant increases in cough peak flow and forced vital capacity compared with the control group, while the IMT group showed significant increases in inspiratory muscle strength compared with the cough training and control groups.","['Fifty-three ambulatory older adults without airflow limitations', 'Older Adults', 'older adults', 'ambulatory older adults']","['4-week home-based CT program', 'IMT', 'Cough Training and Inspiratory Muscle Training', '4-week home-based unsupervised cough training (CT) or inspiratory muscle training (IMT) program', 'CT']","['Cough Strength', 'inspiratory muscle strength', 'cough strength', 'Cough strength (cough peak flow), forced vital capacity, and respiratory muscle strength', 'cough peak flow and forced vital capacity', 'cough peak flow']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4708767', 'cui_str': 'Cough strength'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0857465', 'cui_str': 'Peak flow'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}]",53.0,0.0187027,"At the 4-week follow-up, the CT group showed significant increases in cough peak flow and forced vital capacity compared with the control group, while the IMT group showed significant increases in inspiratory muscle strength compared with the cough training and control groups.","[{'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Kaneko', 'Affiliation': 'Department of Physical Therapy, School of Health Sciences at Fukuoka, International University of Health and Welfare, 137-1 Enokizu, Okawa-shi, Fukuoka, 831-8501, Japan. hkaneko@iuhw.ac.jp.'}, {'ForeName': 'Akari', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'Department of Physical Therapy, School of Health Sciences at Fukuoka, International University of Health and Welfare, 137-1 Enokizu, Okawa-shi, Fukuoka, 831-8501, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Horie', 'Affiliation': 'Department of Physical Therapy, School of Health Sciences, Kyoto Tachibana University, Kyoto, Japan.'}]",Lung,['10.1007/s00408-022-00509-2']
3580,35042097,"Association of depression symptom level with smoking urges, cigarette withdrawal, and smoking reinstatement: A preliminary laboratory study.","BACKGROUND


Cigarette smoking urges, withdrawal, and smoking reinstatement may be especially relevant to people with elevated depression symptoms who smoke. This laboratory study aimed to assess relations between depression symptom level and smoking urges for reward and relief, cigarette withdrawal, and smoking reinstatement in people who smoke cigarettes daily during acute abstinence and while smoking as usual.
METHODS


Participants with low (n = 51) or elevated (n = 29) baseline depression symptoms underwent two counterbalanced laboratory sessions (i.e., abstinent, non-abstinent). At each session, they completed subjective measures of smoking urges for reward and relief, and withdrawal. They also completed a laboratory smoking reinstatement task measuring whether they would delay smoking and the number of cigarettes smoked.
RESULTS


The elevated depression symptom group reported significantly higher withdrawal (p = .01) and smoked more cigarettes than the low depression symptoms group during the smoking reinstatement task self-administration period at the abstinent session (p = .04). Smoking urges for reward and relief were not significantly different by depression symptom group. There were no significant interactions of depression and abstinence with any outcomes.
CONCLUSIONS


As outcomes were measured at both an abstinent and non-abstinent session, findings identify factors for people with elevated depression symptoms who smoke which may drive smoking behavior and impede smoking cessation efforts. This study provides evidence that people with elevated depression symptoms who smoke may need additional/more pharmacological or behavioral smoking cessation aids targeted at reducing withdrawal and number of cigarettes smoked.",2022,The elevated depression symptom group reported significantly higher withdrawal (p = .01) and smoked more cigarettes than the low depression symptoms group during the smoking reinstatement task self-administration period at the abstinent session (p = .04).,"['people who smoke cigarettes daily during acute abstinence and while smoking as usual', 'Participants with low (n\xa0=\xa051) or elevated (n\xa0=\xa029) baseline depression symptoms underwent two counterbalanced laboratory sessions (i.e., abstinent, non-abstinent', 'people with elevated depression symptoms who smoke']",[],"['depression and abstinence', 'subjective measures of smoking urges for reward and relief, and withdrawal']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}]",[],"[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",,0.0543153,The elevated depression symptom group reported significantly higher withdrawal (p = .01) and smoked more cigarettes than the low depression symptoms group during the smoking reinstatement task self-administration period at the abstinent session (p = .04).,"[{'ForeName': 'Chyna J', 'Initials': 'CJ', 'LastName': 'Tucker', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, 2001 N. Soto St., Los Angeles, CA 90032, USA; Department of Social Welfare, University of California, Los Angeles, 3250 Public Affairs Building, Los Angeles, CA 90095, USA. Electronic address: chynatucker@ucla.edu.'}, {'ForeName': 'Mariel S', 'Initials': 'MS', 'LastName': 'Bello', 'Affiliation': 'Department of Psychology, University of Southern California, 3620 McClintock Ave., Los Angeles, CA 90089, USA; Department of Psychiatry & Human Behavior, Warren Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903 USA. Electronic address: marielbe@usc.edu.'}, {'ForeName': 'Andrea H', 'Initials': 'AH', 'LastName': 'Weinberger', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University and Department of Epidemiology, and Population Health, Albert Einstein College of Medicine, 1165 Morris Park Ave. Rousso Building, Bronx, NY 10461, USA. Electronic address: andrea.weinberger@yu.edu.'}, {'ForeName': 'Lina M', 'Initials': 'LM', 'LastName': ""D'Orazio"", 'Affiliation': 'Department of Neurology, University of Southern California, 1520 San Pablo St. Los Angeles, CA 90033, USA. Electronic address: lina.dorazio@med.usc.edu.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, 2001 N. Soto St., Los Angeles, CA 90032, USA; Department of Psychology, University of Southern California, 3620 McClintock Ave., Los Angeles, CA 90089, USA. Electronic address: mgkirkpa@usc.edu.'}, {'ForeName': 'Raina D', 'Initials': 'RD', 'LastName': 'Pang', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, 2001 N. Soto St., Los Angeles, CA 90032, USA; Department of Psychology, University of Southern California, 3620 McClintock Ave., Los Angeles, CA 90089, USA. Electronic address: rpang@usc.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2022.109267']
3581,35048156,Effects of progressive resistance training in individuals with type 2 diabetic polyneuropathy: a randomised assessor-blinded controlled trial.,"AIMS/HYPOTHESIS


The aim of this study was to evaluate the effects of progressive resistance training (PRT) on muscle strength, intraepidermal nerve fibre density (IENFD) and motor function in individuals with type 2 diabetic polyneuropathy (DPN) and to compare potential adaptations to those of individuals with type 2 diabetes without DPN and healthy controls.
METHODS


This was an assessor-blinded trial conducted at the Neurology department, Aarhus University Hospital. Adults with type 2 diabetes, with and without DPN and healthy control participants were randomised to either supervised PRT or non-PRT for 12 weeks. Allocation was concealed by a central office unrelated to the study. The co-primary outcomes were muscle strength in terms of the peak torque of the knee and ankle extensors and flexors, and IENFD. Secondary outcome measures included the 6 min walk test (6MWT), five-time sit-to-stand test (FTSST) and postural stability index obtained by static posturography.
RESULTS


A total of 109 individuals were enrolled in three groups (type 2 diabetes with DPN [n = 42], type 2 diabetes without DPN [n = 32] and healthy control [n = 35]). PRT resulted in muscle strength gains of the knee extensors and flexors in all three groups using comparative analysis (DPN group, PRT 10.3 ± 9.6 Nm vs non-PRT -0.4 ± 8.2 Nm; non-DPN group, PRT 7.5 ± 5.8 Nm vs non-PRT 0.6 ± 8.8 Nm; healthy control group, PRT 6.3 ± 9.0 Nm vs non-PRT -0.4 ± 8.4 Nm; p<0.05, respectively). Following PRT the DPN group improved the 6MWT (PRT 34.6 ± 40.9 m vs non-PRT 2.7 ± 19.6 m; p=0.001) and the FTSST (PRT -1.5 ± 2.2 s vs non-PRT 1.5 ± 4.6 s; p=0.02). There was no change in IENFD following PRT in any of the groups.
CONCLUSIONS/INTERPRETATION


PRT improved muscle strength of the knee extensors and flexors and motor function in individuals with type 2 diabetic polyneuropathy at levels comparable with those seen in individuals with diabetes without DPN and healthy control individuals, while no effects were observed in IENFD.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03252132 FUNDING: Research reported in this paper is part of the International Diabetic Neuropathy Consortium (IDNC) research programme, supported by a Novo Nordisk Foundation Challenge Program grant (grant no. NNF14OC0011633) and Aarhus University.",2022,"PRT resulted in muscle strength gains of the knee extensors and flexors in all three groups using comparative analysis (DPN group, PRT 10.3 ± 9.6 Nm vs non-PRT -0.4 ± 8.2 Nm; non-DPN group, PRT 7.5 ± 5.8 Nm vs non-PRT 0.6 ± 8.8 Nm; healthy control group, PRT 6.3 ± 9.0","['individuals with type 2 diabetic polyneuropathy (DPN', 'Neurology department, Aarhus University Hospital', 'individuals with type 2 diabetes without DPN and healthy controls', 'individuals with type 2 diabetic polyneuropathy', '109 individuals were enrolled in three groups (type 2 diabetes with DPN [n = 42], type 2 diabetes without DPN [n = 32] and healthy control [n = 35', 'Adults with type 2 diabetes, with and without DPN and healthy control participants']","['supervised PRT or non-PRT', 'progressive resistance training (PRT', 'progressive resistance training', 'PRT']","['IENFD', '6 min walk test (6MWT), five-time sit-to-stand test (FTSST) and postural stability index obtained by static posturography', 'muscle strength in terms of the peak torque of the knee and ankle extensors and flexors, and IENFD', 'muscle strength gains', 'muscle strength, intraepidermal nerve fibre density (IENFD) and motor function', 'muscle strength of the knee extensors and flexors and motor function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0271680', 'cui_str': 'Diabetic polyneuropathy'}, {'cui': 'C0587475', 'cui_str': 'Neurology department'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C3839460', 'cui_str': 'Non-progressive'}]","[{'cui': 'C0027749', 'cui_str': 'Nerve fiber'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",109.0,0.0514422,"PRT resulted in muscle strength gains of the knee extensors and flexors in all three groups using comparative analysis (DPN group, PRT 10.3 ± 9.6 Nm vs non-PRT -0.4 ± 8.2 Nm; non-DPN group, PRT 7.5 ± 5.8 Nm vs non-PRT 0.6 ± 8.8 Nm; healthy control group, PRT 6.3 ± 9.0","[{'ForeName': 'Karolina S', 'Initials': 'KS', 'LastName': 'Khan', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark. kasnop@rm.dk.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Overgaard', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Tankisi', 'Affiliation': 'International Diabetic Neuropathy Consortium, Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Pall', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Devantier', 'Affiliation': 'Department of Oto-Rhino-Laryngology, Regional Hospital West Jutland, Holstebro, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Gregersen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Troels S', 'Initials': 'TS', 'LastName': 'Jensen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Nanna B', 'Initials': 'NB', 'LastName': 'Finnerup', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Andersen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}]",Diabetologia,['10.1007/s00125-021-05646-6']
3582,35051669,Manual fetal stimulation during intrapartum fetal surveillance: a randomized controlled trial.,"BACKGROUND


Manual fetal stimulation, either by mechanical manipulation or by stimulation of the fetal scalp, is known to evoke a fetal heart response in a normal fetus.
OBJECTIVE


This study aimed to assess the clinical effectiveness of manual fetal stimulation in the assessment of fetal well-being during labor vs no stimulation among women with a singleton pregnancy and to investigate the maternal and neonatal outcomes in the 2 groups.
STUDY DESIGN


This was a randomized controlled trial conducted in the department of obstetrics and gynecology at a tertiary care teaching hospital between 2014 and 2016. The inclusion criteria included women with a singleton pregnancy at ≥37 weeks of gestation with cephalic presentation in labor having one of the following abnormalities on fetal heart tracing: fetal heart rate of <110 bpm or >160 bpm, variable decelerations, late decelerations, and minimal or absent beat-to-beat variability. The exclusion criteria included women requiring immediate cesarean delivery, conditions that would preclude a vaginal delivery, and intrauterine fetal demise or a major fetal congenital abnormality. The women were followed up in labor and randomized to either the manual stimulation group or the no stimulation group when one of the cardiotocography abnormalities were present. In the manual stimulation group, the fetus was stimulated abdominally by holding the head in the palm of 1 hand when the cervical dilatation was <3 cm or vaginally by pinching the scalp of the fetus when the cervical dilatation was ≥3 cm. After delivery, a cord blood sample was collected and pH estimated. Mother and baby were followed up until discharge, and mode of delivery, cord blood pH at birth, Apgar scores at 1 minute and 5 minutes, neonatal intensive care unit admissions, and duration of stay were the outcomes studied. Data were entered and compiled as frequency and percentage for categorical variables. For continuous variables, data were calculated using mean and standard deviation. The chi-square test was used for assessing the association between the intervention and fetal and maternal outcomes.
RESULTS


A total of 327 women were included in the trial, of whom 164 were in the manual fetal stimulation group (group 1) and 163 were in the ""no stimulation"" group (group 2). The cesarean delivery rates were 25.61% in group 1 and 30.67% in group 2 (P=.308). The mean cord blood pH levels at birth were 7.267±0.027 in group 1 and 7.265±0.024 in group 2 (P=.479), and the Apgar scores at 1 minute and 5 minutes (P=.169 and P=.423, respectively, between the 2 groups) were not found to be statistically different among the 2 groups.
CONCLUSION


There was no considerable change in fetomaternal outcomes with manual fetal stimulation in women having nonreassuring cardiotocographic changes in labor.",2022,There was no considerable change in fetomaternal outcomes with manual fetal stimulation in women having nonreassuring cardiotocographic changes in labor.,"['A total of 327 women were included in the trial, of whom 164 were in the manual fetal stimulation group (group 1) and 163 were in the ""no stimulation"" group (group 2', 'women requiring immediate cesarean delivery, conditions that would preclude a vaginal delivery, and intrauterine fetal demise or a major fetal congenital abnormality', 'department of obstetrics and gynecology at a tertiary care teaching hospital between 2014 and 2016', 'women with a singleton pregnancy', 'women with a singleton pregnancy at ≥37 weeks of gestation with cephalic presentation in labor having one of the following abnormalities on fetal heart tracing: fetal heart rate of <110 bpm or >160 bpm, variable decelerations, late decelerations, and minimal or absent beat-to-beat variability']","['manual fetal stimulation', 'manual stimulation group or the no stimulation', 'Manual fetal stimulation']","['Apgar scores', 'mean cord blood pH levels at birth', 'cesarean delivery rates', 'fetomaternal outcomes']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0445093', 'cui_str': 'No stimulation'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015935', 'cui_str': 'Fetal Heart'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0457245', 'cui_str': 'Variable deceleration - finding'}, {'cui': 'C0429482', 'cui_str': 'Late fetal heart deceleration'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0429478', 'cui_str': 'Fetal heart rate variability'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445093', 'cui_str': 'No stimulation'}]","[{'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C1304686', 'cui_str': 'pH - finding'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",327.0,0.0753514,There was no considerable change in fetomaternal outcomes with manual fetal stimulation in women having nonreassuring cardiotocographic changes in labor.,"[{'ForeName': 'Sultana', 'Initials': 'S', 'LastName': 'Tahmina', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pondicherry Institute of Medical Sciences, Puducherry, India (Drs Tahmina and Daniel); Department of Obstetrics and Gynaecology, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, Melmaruvathur, India (Dr Tahmina). Electronic address: dr.tahmina.s@gmail.com.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Daniel', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pondicherry Institute of Medical Sciences, Puducherry, India (Drs Tahmina and Daniel).'}, {'ForeName': 'Lalitha', 'Initials': 'L', 'LastName': 'Krishnan', 'Affiliation': 'and Department of Paediatrics, Pondicherry Institute of Medical Sciences, Puducherry, India (Dr Krishnan).'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100574']
3583,34969004,Transversus abdominis plane block with liposomal bupivacaine versus continuous epidural analgesia for major abdominal surgery: The EXPLANE randomized trial.,"OBJECTIVE


Compare transversus abdominis plane (TAP) blocks with liposomal bupivacaine were to epidural analgesia for pain at rest and opioid consumption in patients recovering from abdominal surgery.
BACKGROUND


ERAS pathways suggest TAP blocks in preference to epidural analgesia for abdominal surgery. However, the relative efficacies of TAP blocks and epidural analgesia remains unknown.
METHODS


Patients having major abdominal surgery were enrolled at six sites and randomly assigned 1:1 to thoracic epidural analgesia or bilateral/4-quadrant TAP blocks with liposomal bupivacaine. Intravenous opioids were used as needed. Non-inferiority margins were a priori set at 1 point on an 11-point pain numeric rating scale for pain at rest and at a 25% increase in postoperative opioid consumption.
RESULTS


Enrollment was stopped per protocol at 3rd interim analysis after crossing an a priori futility boundary. 498 patients were analyzed (255 had TAP blocks and 243 had epidurals). Pain scores at rest in patients assigned to TAP blocks were significantly non-inferior to those given epidurals, with an estimated difference of 0.09 points (CI: -0.12, 0.30; noninferiority P < 0.001). Opioid consumption during the initial 3 postoperative days in TAP patients was not non-inferior to epidurals, with an estimated ratio of geometric means of 1.37 (CI: 1.05, 1.79; non-inferiority P = 0.754). However, the absolute difference was only 21 mg morphine equivalents over the 3 days. Patients with epidurals were more likely to experience mean arterial pressures <65 mmHg than those given TAP blocks: 48% versus 31%, P = 0.006.
CONCLUSION


Pain scores at rest during the initial three days after major abdominal surgery were similar. Patients assigned to TAP blocks required more opioid then epidural patients but had less hypotension. Clinicians should reconsider epidural analgesia in patients at risk from hypotension.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02996227.",2022,"Pain scores at rest in patients assigned to TAP blocks were significantly non-inferior to those given epidurals, with an estimated difference of 0.09 points (CI: -0.12, 0.30; noninferiority P < 0.001).","['patients at risk from hypotension', 'major abdominal surgery', 'Patients having major abdominal surgery were enrolled at six sites', 'patients recovering from abdominal surgery', '498 patients were analyzed (255 had TAP blocks and 243 had epidurals']","['liposomal bupivacaine', 'Intravenous opioids', 'transversus abdominis plane (TAP) blocks with liposomal bupivacaine', 'TAP blocks', 'thoracic epidural analgesia or bilateral/4-quadrant TAP blocks with liposomal bupivacaine']","['Pain scores', 'pain at rest and opioid consumption', 'postoperative opioid consumption', 'experience mean arterial pressures', 'Opioid consumption', 'hypotension', '11-point pain numeric rating scale for pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",498.0,0.484211,"Pain scores at rest in patients assigned to TAP blocks were significantly non-inferior to those given epidurals, with an estimated difference of 0.09 points (CI: -0.12, 0.30; noninferiority P < 0.001).","[{'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America; Department of General Anesthesiology, Cleveland Clinic, United States of America. Electronic address: turana@ccf.org.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Cohen', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America; Division of Anesthesiology, Intensive Care, and Pain Management, Tel-Aviv Medical Center, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Elsharkawy', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America; Pain Center, Anesthesiology Department, MetroHealth, Case Western Reserve University, OH, United States of America.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America; Department of General Anesthesiology, Cleveland Clinic, United States of America.'}, {'ForeName': 'Loran Mounir', 'Initials': 'LM', 'LastName': 'Soliman', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, United States of America.'}, {'ForeName': 'Rovnat', 'Initials': 'R', 'LastName': 'Babazade', 'Affiliation': 'Department of Anesthesiology, University of Texas Medical Branch of Galveston, TX, United States of America.'}, {'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America; Department of General Anesthesiology, Cleveland Clinic, United States of America.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Hassan', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, United States of America.'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Elkassabany', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, United States of America.'}, {'ForeName': 'Hani A', 'Initials': 'HA', 'LastName': 'Essber', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Kessler', 'Affiliation': 'Department of Colorectal Surgery, Cleveland Clinic, United States of America.'}, {'ForeName': 'Guangmei', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America; Department of Quantitative Health Sciences, Cleveland Clinic.'}, {'ForeName': 'Wael Ali Sakr', 'Initials': 'WAS', 'LastName': 'Esa', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America; Department of General Anesthesiology, Cleveland Clinic, United States of America.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2021.110640']
3584,35051671,"Preoperative vaginal cleansing with chlorhexidine vs placebo in patients with rupture of membranes: a prospective, randomized, double-blind, placebo-control study.","BACKGROUND


XXX OBJECTIVE: This study aimed to demonstrate that vaginal cleansing with a 4% chlorhexidine solution before cesarean delivery in patients with a history of rupture of membranes prevents postoperative infectious complications (endometritis, surgical site infections).
STUDY DESIGN


A total of 204 patients with premature rupture of membranes or who were in labor for more than 6 hours after membranes ruptured were randomized before a cesarean delivery to preoperative vaginal cleansing with a chlorhexidine solution (n=97 patients) or to placebo cleansing with saline solution (n=107 patients). The management of the rupture of membranes and the cesarean delivery procedure were conducted according to standard local protocols for both groups, including the use of antibiotics.
RESULTS


Vaginal cleansing with chlorhexidine reduced the risk for endometritis after cesarean delivery in patients with rupture of membranes when compared with placebo cleansing (chlorhexidine, 7.21% vs placebo, 18.8%; relative risk, 0.39; 95% confidence interval, 0.17-0.87; P=.015). Likewise, there was a statistically significant reduction in the number of cases of puerperal fever (chlorhexidine, 9.28% vs placebo, 19.8%; relative risk, 0.47; 95% confidence interval, 0.23-0.98; P=.037). There was a statistical difference between the groups in prolongation of hospitalization for >72 hours (chlorhexidine, 1.03% vs placebo, 7.55%; relative risk, 0.14; 95% confidence interval, 0.02-1.08; P=.02), although the confidence interval suggests that the effect was by chance. There were no statistical differences in surgical site infection at 7 days (chlorhexidine, 1.03% vs placebo, 0.94%; relative risk, 1.1; 95% confidence interval, 0.07-17.4; P=.94) and 15 days after the procedure (chlorhexidine, 1.03% vs placebo, 0%; relative risk, 3.31 [using a continuity correction]; 95% confidence interval, 0.14-80.21; P=.29).
CONCLUSION


The use of chlorhexidine for vaginal cleansing before a cesarean delivery in patients with rupture of membranes reduced the risk for endometritis and puerperal fever. It also reduced the number of cases that required hospitalization for more than 3 days, but the confidence interval suggests that it could be by chance. It has no effect on the number of cases with surgical site infection.",2022,"There were no statistical differences in surgical site infection at 7 days (chlorhexidine, 1.03% vs placebo, 0.94%; relative risk, 1.1; 95% confidence interval, 0.07-17.4; P=.94) and 15 days after the procedure (chlorhexidine, 1.03% vs placebo, 0%; relative risk, 3.31 [using a continuity correction]; 95% confidence interval, 0.14-80.21; P=.29).
","['patients with rupture of membranes', '204 patients with premature rupture of membranes or who were in labor for more than 6 hours after membranes ruptured', 'patients with a history of rupture of membranes prevents postoperative infectious complications (endometritis, surgical site infections', 'n=107 patients', 'patients with rupture of membranes reduced the risk for endometritis and puerperal fever']","['placebo', 'placebo cleansing with saline solution', 'cesarean delivery to preoperative vaginal cleansing with a chlorhexidine solution', 'vaginal cleansing with a 4% chlorhexidine solution', 'placebo cleansing (chlorhexidine', 'chlorhexidine', 'chlorhexidine vs placebo']","['number of cases of puerperal fever', 'risk for endometritis', 'surgical site infection', 'prolongation of hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0233308', 'cui_str': 'Spontaneous rupture of fetal membranes'}, {'cui': 'C0015944', 'cui_str': 'Premature rupture of membranes'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0157536', 'cui_str': 'Puerperal pyrexia of unknown origin'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0157536', 'cui_str': 'Puerperal pyrexia of unknown origin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",204.0,0.490009,"There were no statistical differences in surgical site infection at 7 days (chlorhexidine, 1.03% vs placebo, 0.94%; relative risk, 1.1; 95% confidence interval, 0.07-17.4; P=.94) and 15 days after the procedure (chlorhexidine, 1.03% vs placebo, 0%; relative risk, 3.31 [using a continuity correction]; 95% confidence interval, 0.14-80.21; P=.29).
","[{'ForeName': 'Nestor', 'Initials': 'N', 'LastName': 'Ureña', 'Affiliation': 'Maternidad del Hospital Santo Tomás, Panamá.'}, {'ForeName': 'Osvaldo', 'Initials': 'O', 'LastName': 'Reyes', 'Affiliation': 'Maternidad del Hospital Santo Tomás, Panamá; Sistema Nacional de Investigadores de Panamá (SNI). Electronic address: oreyespanama@yahoo.es.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2022.100572']
3585,34877769,Baseline- and treatment-associated pain in the X:BOT comparative effectiveness study of extended-release naltrexone versus buprenorphine-naloxone for OUD.,"Chronic pain is highly prevalent among patients with opioid use disorder (OUD). However, little is known about how pharmacological treatments for OUD, for example, extended-release naltrexone (XR-NTX) and buprenorphine-naloxone (BUP-NX), affect pain. To begin addressing this question, we performed a secondary analysis of pain data on a large prospective 24-week, open-label, randomized-controlled comparative effectiveness trial of XR-NTX versus BUP-NX (X:BOT trial). Participants' pain status was measured by the EuroQol (EQ-5D). Based on their responses to the pain question at baseline, participants were dichotomized into ""Pain"" versus ""No Pain"" categories. Participant's pain status was evaluated every 4 weeks. A mixed effects longitudinal logistic regression model was fitted to examine the differential effect of XR-NTX versus BUP-NX on pain, modelling pain at all available follow-up assessments, adjusted for age, sex, and baseline pain. A total of 474 individuals who were successfully inducted onto their assigned medications were included in this analysis. Among participants endorsing pain at baseline, substantial reductions in pain were observed over the course of the study in both treatment groups. Howecver reduction in pain was slightly greater in the group treated with XR-NTX than the one treated with BUP-NX (OR = 1.60 [95% CI: 1.07-2.40], P = 0.023). Future research using instruments and design specifically focused on pain could extend the present observations and evaluate their clinical significance.",2022,"Howecver reduction in pain was slightly greater in the group treated with XR-NTX than the one treated with BUP-NX (OR = 1.60 [95% CI: 1.07-2.40], P = 0.023).","['474 individuals who were successfully inducted onto their assigned medications were included in this analysis', 'patients with opioid use disorder (OUD']","['buprenorphine-naloxone', 'XR-NTX', 'Baseline', 'buprenorphine-naloxone (BUP-NX', 'XR-NTX versus BUP-NX', 'naltrexone']","['Howecver reduction in pain', 'pain', 'pain status', ""Participant's pain status"", 'Chronic pain', 'pain, modelling pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",474.0,0.187065,"Howecver reduction in pain was slightly greater in the group treated with XR-NTX than the one treated with BUP-NX (OR = 1.60 [95% CI: 1.07-2.40], P = 0.023).","[{'ForeName': 'An-Li', 'Initials': 'AL', 'LastName': 'Wang', 'Affiliation': 'Addiction Institute of Mount Sinai, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Matisyahu', 'Initials': 'M', 'LastName': 'Shulman', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, New York, New York, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, New York, New York, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health, New York, New York, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Langleben', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, New York, New York, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'Department of Psychiatry, NYU Grossman School of Medicine, New York, New York, USA.'}]",Addiction biology,['10.1111/adb.13112']
3586,34861374,Veliparib monotherapy following carboplatin/paclitaxel plus veliparib combination therapy in patients with germline BRCA-associated advanced breast cancer: results of exploratory analyses from the phase III BROCADE3 trial.,"BACKGROUND


In the BROCADE3 trial, addition of the poly(ADP-ribose) polymerase inhibitor, veliparib, to carboplatin/paclitaxel improved progression-free survival (PFS) (hazard ratio 0.71, 95% confidence interval 0.57-0.88; P = 0.002) in patients with advanced human epidermal growth factor receptor 2-negative, germline BRCA1/2-mutated breast cancer. A subset of patients discontinued both carboplatin and paclitaxel before progression and continued on veliparib/placebo maintenance monotherapy until progression. Analyses in this patient subgroup are reported.
PATIENTS AND METHODS


Patients were randomized 2 : 1 to veliparib plus carboplatin/paclitaxel or placebo plus carboplatin/paclitaxel. Veliparib (120 mg twice daily) or placebo was given on days -2 to 5, carboplatin (area under the curve 6 mg/ml) on day 1, and paclitaxel (80 mg/m 2 ) on days 1, 8, and 15 of 21-day cycles. Patients who discontinued both carboplatin and paclitaxel before progression received blinded study drug monotherapy at an increased dose of 300-400 mg twice daily continuously. PFS was the primary endpoint. Exploratory analyses were carried out in the subgroup of patients who received blinded study drug as monotherapy. A time-varying Cox model including data from all patients was also used to evaluate treatment effect in the combination and monotherapy phases.
RESULTS


A total of 136 of 337 patients randomized to veliparib plus carboplatin/paclitaxel and 58/172 patients randomized to placebo plus carboplatin/paclitaxel discontinued both carboplatin and paclitaxel before progression and continued on blinded veliparib or placebo monotherapy. In this blinded monotherapy subgroup, investigator-assessed median PFS from randomization was 25.7 months with veliparib versus 14.6 months with placebo. Hazard ratios from a time-varying Cox model favored veliparib during both combination therapy and monotherapy. Any-grade adverse events occurring in the monotherapy phase were primarily gastrointestinal. The most common grade ≥3 adverse events were neutropenia and anemia (4% each with veliparib; 5% and 2%, respectively, with placebo).
CONCLUSIONS


Veliparib maintenance monotherapy had a tolerable safety profile and may extend PFS following combination chemotherapy.",2022,Any-grade adverse events occurring in the monotherapy phase were primarily gastrointestinal.,"['patients with germline BRCA-associated advanced breast cancer', 'patients with advanced human epidermal growth factor receptor 2-negative, germline BRCA1/2-mutated breast cancer', 'A total of 136 of 337 patients randomized to', 'Patients were randomized 2 : 1 to']","['placebo', 'carboplatin (area under the curve 6 mg/ml) on day 1, and paclitaxel', 'Veliparib', 'carboplatin and paclitaxel', 'veliparib plus carboplatin/paclitaxel or placebo plus carboplatin/paclitaxel', 'veliparib plus carboplatin/paclitaxel', 'carboplatin/paclitaxel', 'monotherapy', 'placebo monotherapy', 'placebo plus carboplatin/paclitaxel discontinued both carboplatin and paclitaxel', 'Veliparib monotherapy following carboplatin/paclitaxel plus veliparib combination therapy']","['tolerable safety profile', 'progression-free survival (PFS', 'neutropenia and anemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517568', 'cui_str': '136'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1958300', 'cui_str': 'veliparib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",337.0,0.559392,Any-grade adverse events occurring in the monotherapy phase were primarily gastrointestinal.,"[{'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Moffitt Cancer Center, Tampa, USA. Electronic address: hyo.han@moffitt.org.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Arun', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kaufman', 'Affiliation': 'Sheba Medical Center, Tel HaShomer, Ramat Gan, Israel.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wildiers', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Prince of Wales Clinical School UNSW and Prince of Wales Hospital, Sydney, Australia.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Ayoub', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montréal, Canada.""}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Puhalla', 'Affiliation': 'University of Pittsburgh Medical Center, Hillman Cancer Center, Pittsburgh, USA.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Bach', 'Affiliation': 'AbbVie Inc., North Chicago, USA.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Kundu', 'Affiliation': 'AbbVie Inc., North Chicago, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Khandelwal', 'Affiliation': 'AbbVie Inc., North Chicago, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Feng', 'Affiliation': 'AbbVie Inc., North Chicago, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bhattacharya', 'Affiliation': 'AbbVie Inc., North Chicago, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Maag', 'Affiliation': 'AbbVie Inc., North Chicago, USA.'}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Ratajczak', 'Affiliation': 'AbbVie Inc., North Chicago, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Institut Curie, Paris, France; Centre Eugène Marquis, Rennes, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.11.018']
3587,32039635,Sleep Discrepancy in a Randomized Controlled Trial of Brief Behavioral Therapy for Chronic Insomnia in Older Adults.,"Background/Objective : Some older adults with insomnia experience sleep discrepancy, often characterized by greater subjective sleep difficulties and shorter subjective sleep duration than the estimates derived from objective measures. The present study examined whether a brief behavioral therapy for insomnia (BBTi) is efficacious for reducing sleep discrepancy in older adults.  Methods : This study is a secondary analysis of a randomized controlled trial of BBTi for community dwelling older adults with chronic insomnia (N = 62). Thirty-two participants received BBTi, delivered in four individual face-to-face sessions. Thirty received the self-monitoring control (SMC). They all completed daily sleep diaries and wore an actigraph from baseline to posttreatment, and for 2 weeks at 3-month follow-up. Sleep discrepancy was calculated by subtracting diary from actigraphy estimates of sleep onset latency (SOL), wake after sleep onset (WASO), and total sleep time (TST). Mixed modeling was used to analyze data. SOL discrepancy decreased significantly in BBTi participants compared to SMC participants. The decreases in SOL discrepancy were explained by changes in diary-assessed SOL and subjective sleep quality but not changes in actigraphy-assessed SOL. Although WASO discrepancy and TST discrepancy decreased from baseline to posttreatment and follow-up, the Time by Group interaction effects were not significant indicating that BBTi participants did not experience greater reductions in WASO discrepancy and TST discrepancy than SMC participants. In conclusion, BBTi is efficacious for reducing SOL discrepancy in older adults with chronic insomnia.",2021,The decreases in SOL discrepancy were explained by changes in diary-assessed SOL and subjective sleep quality but not changes in actigraphy-assessed SOL.,"['community dwelling older adults with chronic insomnia (N = 62', 'older adults with insomnia experience sleep discrepancy', 'older adults with chronic insomnia', 'Chronic Insomnia in Older Adults', 'older adults']","['behavioral therapy for insomnia (BBTi', 'BBTi', 'self-monitoring control (SMC', 'Behavioral Therapy']","['SOL discrepancy', 'WASO discrepancy and TST discrepancy', 'diary-assessed SOL and subjective sleep quality', 'sleep onset latency (SOL), wake after sleep onset (WASO), and total sleep time (TST', 'Sleep discrepancy']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751249', 'cui_str': 'Chronic Insomnia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0701413', 'cui_str': 'Sol'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",62.0,0.0354771,The decreases in SOL discrepancy were explained by changes in diary-assessed SOL and subjective sleep quality but not changes in actigraphy-assessed SOL.,"[{'ForeName': 'Wai Sze', 'Initials': 'WS', 'LastName': 'Chan', 'Affiliation': 'Department of Psychology, University of Hong Kong , Hong Kong.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Dautovich', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University , Richmond, Virginia.'}, {'ForeName': 'Joseph P H', 'Initials': 'JPH', 'LastName': 'McNamara', 'Affiliation': 'Department of Psychiatry, University of Florida , Gainesville, Florida.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Stripling', 'Affiliation': 'College of Psychology, Nova Southeastern University , Fort Lauderdale, Florida.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Dzierzewski', 'Affiliation': 'College of Medicine, University of Florida , Gainesville, Florida.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'McCoy', 'Affiliation': 'Neuropsychology Service, South Texas Veterans Health Care System , San Antonio, Texas.'}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'McCrae', 'Affiliation': 'Department of Psychiatry, University of Missouri , Columbia, Missouri.'}]",Behavioral sleep medicine,['10.1080/15402002.2020.1726750']
3588,31387868,A Pivotal Response Treatment Package for Children With Autism Spectrum Disorder: An RCT.,"OBJECTIVES


Our aim was to conduct a randomized controlled trial to evaluate a pivotal response treatment package (PRT-P) consisting of parent training and clinician-delivered in-home intervention on the communication skills of children with autism spectrum disorder.
METHODS


Forty-eight children with autism spectrum disorder and significant language delay between 2 and 5 years old were randomly assigned to PRT-P ( n  = 24) or the delayed treatment group ( n  = 24) for 24 weeks. The effect of treatment on child communication skills was assessed via behavioral coding of parent-child interactions, standardized parent-report measures, and blinded clinician ratings.
RESULTS


Analysis of child utterances during the structured laboratory observation revealed that, compared with the delayed treatment group, children in PRT-P demonstrated greater improvement in frequency of functional utterances (F 1,41  = 6.07;  P  = .026;  d  = 0.61). The majority of parents in the PRT-P group (91%) were able to implement pivotal response treatment (PRT) with fidelity within 24 weeks. Children receiving PRT-P also demonstrated greater improvement on the Brief Observation of Social Communication Change, on the Clinical Global Impressions Improvement subscale, and in number of words used on a parent-report questionnaire.
CONCLUSIONS


This is the first 24-week randomized controlled trial in which community treatment is compared with the combination of parent training and clinician-delivered PRT. PRT-P was effective for improving child social communication skills and for teaching parents to implement PRT. Additional research will be needed to understand the optimal combination of treatment settings, intensity, and duration, and to identify child and parent characteristics associated with treatment response.",2019,"Children receiving PRT-P also demonstrated greater improvement on the Brief Observation of Social Communication Change, on the Clinical Global Impressions Improvement subscale, and in number of words used on a parent-report questionnaire.
","['Spectrum Disorder', 'Children With Autism', 'children with autism spectrum disorder', 'Forty-eight children with autism spectrum disorder and significant language delay between 2 and 5 years old']","['pivotal response treatment package (PRT-P) consisting of parent training and clinician-delivered in-home intervention', 'parent training and clinician-delivered PRT']","['child communication skills', 'Clinical Global Impressions Improvement subscale, and in number of words used on a parent-report questionnaire', 'child social communication skills', 'Brief Observation of Social Communication Change', 'frequency of functional utterances']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0023012', 'cui_str': 'Language Delay'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",48.0,0.0718521,"Children receiving PRT-P also demonstrated greater improvement on the Brief Observation of Social Communication Change, on the Clinical Global Impressions Improvement subscale, and in number of words used on a parent-report questionnaire.
","[{'ForeName': 'Grace W', 'Initials': 'GW', 'LastName': 'Gengoux', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Stanford University, Stanford, California; ggengoux@stanford.edu.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Abrams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Schuck', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Maria Estefania', 'Initials': 'ME', 'LastName': 'Millan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Libove', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Ardel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Fox', 'Affiliation': 'PGSP - Stanford Psy.D. Consortium, Palo Alto University, Palo Alto, California; and.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Frazier', 'Affiliation': 'Autism Speaks, New York, New York.'}, {'ForeName': 'Antonio Y', 'Initials': 'AY', 'LastName': 'Hardan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Stanford University, Stanford, California.'}]",Pediatrics,['10.1542/peds.2019-0178']
3589,31429601,The Depression Prevention Initiative: Mediators of Interpersonal Psychotherapy-Adolescent Skills Training.,"Several adolescent depression prevention programs have demonstrated effects on depressive symptoms and overall functioning. Yet, despite an increasing emphasis on elucidating mechanisms of change in interventions, few studies have identified mediators of these preventive interventions. In this study, we examined interpersonal mediators of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), an evidence-based depression prevention program. The Depression Prevention Initiative is a school-based randomized controlled trial in which 186 adolescents ( M  age = 14.01,  SD  = 1.22; 66.7% female; 32.2% racial minority) were assigned to receive either IPT-AST ( n  = 95) or Group Counseling (GC) ( n  = 91). We examined whether change in interpersonal conflict, social support, or social functioning from baseline to midintervention mediated the effects of IPT-AST on depressive symptoms and overall functioning at postintervention. At postintervention, youth in IPT-AST had lower depressive symptoms ( d  = -.31) and higher overall functioning scores ( d  = .32) than youth in GC. Improvements in adolescent romantic functioning, reductions in peer conflict, and improvements in a factor score reflecting mother-adolescent conflict and difficulties in family functioning emerged as significant mediators. However, the effects of the intervention on change in the mediators were not statistically significant. These findings add to the sparse literature on mediators of psychosocial interventions, provide partial support for the theoretical mechanisms underlying change in IPT-AST, and highlight important directions for future prevention and intervention research.",2021,"At postintervention, youth in IPT-AST had lower depressive symptoms ( d  = -.31) and higher overall functioning scores ( d  = .32) than youth in GC.","['186 adolescents ( M  age\xa0=\xa014.01,  SD\xa0 =\xa01.22; 66.7% female; 32.2% racial minority']","['IPT-AST', 'Interpersonal Psychotherapy-Adolescent Skills Training', 'Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST', 'IPT-AST ( n  =\xa095) or Group Counseling (GC']","['depressive symptoms', 'interpersonal conflict, social support, or social functioning', 'depressive symptoms and overall functioning', 'adolescent romantic functioning, reductions in peer conflict', 'overall functioning scores']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy (regime/therapy)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0237547', 'cui_str': 'Group counseling (procedure)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0037438'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",186.0,0.0381103,"At postintervention, youth in IPT-AST had lower depressive symptoms ( d  = -.31) and higher overall functioning scores ( d  = .32) than youth in GC.","[{'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, and PolicyLab Children's Hospital of Philadelphia.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gallop', 'Affiliation': 'Department of Mathematics, West Chester University.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Gillham', 'Affiliation': 'Department of Psychology, Swarthmore College.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mufson', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Farley', 'Affiliation': 'Department of Psychology, Rutgers University.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kanine', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, and PolicyLab Children's Hospital of Philadelphia.""}, {'ForeName': 'Jami F', 'Initials': 'JF', 'LastName': 'Young', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, and PolicyLab Children's Hospital of Philadelphia.""}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2019.1644648']
3590,30649213,Changes in blood lipid concentrations associated with changes in intake of dietary saturated fat in the context of a healthy low-carbohydrate weight-loss diet: a secondary analysis of the Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) trial.,"Background


For low-carbohydrate diets, a public health approach has focused on the replacement of carbohydrates with unsaturated fats. However, little research exists on the impacts of saturated fat intake on the lipid profile in the context of whole-food-based low-carbohydrate weight-loss diets.
Objectives


The primary aim of this secondary analysis of the DIETFITS weight loss trial was to evaluate the associations between changes in percentage of dietary saturated fatty acid intake (%SFA) and changes in low-density lipoproteins, high-density lipoproteins, and triglyceride concentrations for those following a healthy low-carbohydrate (HLC) diet. The secondary aim was to examine these associations specifically for HLC dieters who had the highest 12-month increases in %SFA.
Methods


In the DIETFITS trial, 609 generally healthy adults, aged 18-50 years, with body mass indices of 28-40 kg/m2 were randomly assigned to a healthy low-fat (HLF) or HLC diet for 12 months. In this analysis, linear regression, both without and with adjustment for potential confounders, was used to measure the association between 12-month change in %SFA and blood lipids in 208 HLC participants with complete diet and blood lipid data.
Results


Participants consumed an average of 12-18% of calories from SFA. An increase of %SFA, without significant changes in absolute saturated fat intake, over 12 months was associated with a statistically significant decrease in triglycerides in the context of a weight-loss study in which participants simultaneously decreased carbohydrate intake. The association between increase in %SFA and decrease in triglycerides was no longer significant when adjusting for 12-month change in carbohydrate intake, suggesting carbohydrate intake may be a mediator of this relationship.
Conclusions


Those on a low-carbohydrate weight-loss diet who increase their percentage intake of dietary saturated fat may improve their overall lipid profile provided they focus on a high-quality diet and lower their intakes of both calories and refined carbohydrates. This trial was registered at clinicaltrials.gov as NCT01826591.",2019,"An increase of %SFA, without significant changes in absolute saturated fat intake, over 12 months was associated with a statistically significant decrease in triglycerides in the context of a weight-loss study in which participants simultaneously decreased carbohydrate intake.","['208 HLC participants with complete diet and blood lipid data', '609 generally healthy adults, aged 18-50 years, with body mass indices of 28-40 kg/m2']","['healthy low-carbohydrate (HLC) diet', 'healthy low-fat (HLF) or HLC diet']","['triglycerides', 'absolute saturated fat intake', 'blood lipid concentrations', 'low-density lipoproteins, high-density lipoproteins, and triglyceride concentrations', 'carbohydrate intake']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]",609.0,0.0385969,"An increase of %SFA, without significant changes in absolute saturated fat intake, over 12 months was associated with a statistically significant decrease in triglycerides in the context of a weight-loss study in which participants simultaneously decreased carbohydrate intake.","[{'ForeName': 'Cynthia W', 'Initials': 'CW', 'LastName': 'Shih', 'Affiliation': 'Department of Health Research & Policy.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Hauser', 'Affiliation': 'Stanford Prevention Research Center.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Aronica', 'Affiliation': 'Stanford Prevention Research Center.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rigdon', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqy305']
3591,31825466,Effects of Mirtazapine for Methamphetamine Use Disorder Among Cisgender Men and Transgender Women Who Have Sex With Men: A Placebo-Controlled Randomized Clinical Trial.,"Importance


Methamphetamine use is increasingly prevalent and associated with HIV transmission. A previous phase 2a study of mirtazapine demonstrated reductions in methamphetamine use and sexual risk behaviors among men who have sex with men.
Objective


To determine the efficacy of mirtazapine for treatment of methamphetamine use disorder and reduction in HIV risk behaviors.
Design, Setting, and Participants


This double-blind randomized clinical trial of mirtazapine vs placebo took place from August 2013 to September 2017 in an outpatient research clinic in San Francisco, California. Participants were community-recruited adults who were sexually active; cisgender men, transgender men, and transgender women who (1) had sex with men, (2) had methamphetamine use disorder, and (3) were actively using methamphetamine were eligible. Participants were randomized to receive the study drug or placebo for 24 weeks, with 12 more weeks of follow-up. Data analysis took place from February to June 2018.
Exposures


Mirtazapine, 30 mg, or matched placebo orally once daily for 24 weeks, with background counseling.
Main Outcomes and Measures


Positive urine test results for methamphetamine over 12, 24, and 36 weeks (primary outcomes) and sexual risk behaviors (secondary outcomes). Sleep, methamphetamine craving, dependence severity, and adverse events were assessed.
Results


Of 241 persons assessed, 120 were enrolled (5 transgender women and 115 cisgender men). The mean (SD) age was 43.3 (9.8) years; 61 (50.8%) were white, 31 (25.8%) were African American, and 15 (12.5%) were Latinx. A mean (SD) of 66% (47%) of visits were completed overall. By week 12, the rate of methamphetamine-positive urine test results significantly declined among participants randomized to mirtazapine vs placebo (risk ratio [RR], 0.67 [95% CI, 0.51-0.87]). Mirtazapine resulted in reductions in positive urine test results at 24 weeks (RR, 0.75 [95% CI, 0.56-1.00]) and 36 weeks (RR, 0.73 [95% CI, 0.57-0.96]) vs placebo. Mean (SD) medication adherence by WisePill dispenser was 38.5% (27.0%) in the mirtazapine group vs 39.5% (26.2%) in the placebo group (P = .77) over 2 to 12 weeks and 28.1% (23.4%) vs 38.5% (27.0%) (P = .59) over 13 to 24 weeks. Changes in sexual risk behaviors were not significantly different by study arm at 12 weeks, but those assigned to receive mirtazapine had fewer sexual partners (RR, 0.52 [95% CI, 0.27-0.97]; P = .04), fewer episodes of condomless anal sex with partners who were serodiscordant (RR, 0.47 [95% CI, 0.23-0.97]; P = .04), and fewer episodes of condomless receptive anal sex with partners who were serodiscordant (RR, 0.37 [95% CI, 0.14-0.93]; P = .04) at week 24. Participants assigned to mirtazapine had net reductions in depressive symptoms (Center for Epidemiologic Studies Depression Scale score, 6.2 [95% CI, 1.3-11.1] points lower; P = .01) and insomnia severity (Athens score, 1.4 [95% CI, 0.1-2.7] points lower; P = .04) at week 24. There were no serious adverse events associated with the study drug.
Conclusions and Relevance


In this expanded replication trial, adding mirtazapine to substance use counseling reduced methamphetamine use and some HIV risk behaviors among cisgender men and transgender women who have sex with men, with benefits extending after treatment despite suboptimal medication adherence.
Trial Registration


ClinicalTrials.gov identifier: NCT01888835.",2020,"By week 12, the rate of methamphetamine-positive urine test results significantly declined among participants randomized to mirtazapine vs placebo (risk ratio [RR], 0.67 [95% CI, 0.51-0.87]).","['The mean (SD) age was 43.3 (9.8) years; 61 (50.8%) were white, 31 (25.8%) were African American, and 15 (12.5%) were Latinx', 'men who have sex with men', '241 persons assessed, 120 were enrolled (5 transgender women and 115 cisgender men', 'cisgender men and transgender women who have sex with men', 'August 2013 to September 2017 in an outpatient research clinic in San Francisco, California', 'Participants were community-recruited adults who were sexually active; cisgender men, transgender men, and transgender women who (1) had sex with men, (2) had methamphetamine use disorder, and (3) were actively using methamphetamine were eligible', 'Cisgender Men and Transgender Women']","['Placebo', 'Mirtazapine, 30 mg, or matched placebo', 'mirtazapine vs placebo', 'methamphetamine', 'placebo', 'Methamphetamine', 'Mirtazapine', 'mirtazapine']","['methamphetamine use and sexual risk behaviors', 'rate of methamphetamine-positive urine test', 'Sleep, methamphetamine craving, dependence severity, and adverse events', 'serious adverse events', 'Mean (SD) medication adherence by WisePill dispenser', 'positive urine test results', 'depressive symptoms (Center for Epidemiologic Studies Depression Scale score', 'HIV risk behaviors', 'sexual partners', 'sexual risk behaviors', 'episodes of condomless anal sex', 'insomnia severity', 'episodes of condomless receptive anal sex']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0035168'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}]","[{'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3540005', 'cui_str': 'URINE TESTS'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0180463', 'cui_str': 'Dispenser'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0282347', 'cui_str': 'Anal Sex'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]",120.0,0.70042,"By week 12, the rate of methamphetamine-positive urine test results significantly declined among participants randomized to mirtazapine vs placebo (risk ratio [RR], 0.67 [95% CI, 0.51-0.87]).","[{'ForeName': 'Phillip O', 'Initials': 'PO', 'LastName': 'Coffin', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, California.'}, {'ForeName': 'Glenn-Milo', 'Initials': 'GM', 'LastName': 'Santos', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, California.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Hern', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, California.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Walker', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, California.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Matheson', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, California.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Santos', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, California.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Colfax', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, California.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Batki', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.3655']
3592,30322847,Normothermic versus hypothermic cardiopulmonary bypass in low-risk paediatric heart surgery: a randomised controlled trial.,"OBJECTIVE


To compare normothermic (35°C-36°C) versus hypothermic (28°C) cardiopulmonary bypass (CPB) in paediatric patients undergoing open heart surgery to test the hypothesis that normothermic CPB perfusion maintains the functional integrity of major organ systems leading to faster recovery.
METHODS


Two single-centre, randomised controlled trials (known as  Thermic-1  and  Thermic-2 , respectively) were carried out to compare the effectiveness and acceptability of normothermic versus hypothermic CPB in children with congenital heart disease undergoing open heart surgery. In both studies, the co-primary clinical outcomes were duration of inotropic support, intubation time and postoperative hospital stay.
RESULTS


In total, 200 participants were recruited; 59 to the  Thermic-1  study and 141 to the  Thermic-2  study. 98 patients received normothermic CPB and 102 patients received hypothermic CPB. There were no significant differences between the treatment groups for any of the co-primary outcomes: inotrope duration HR=1.01, 95% CI (0.72 to 1.41); intubation time HR=1.14, 95% CI (0.86 to 1.51); postoperative hospital stay HR=1.06, 95% CI (0.80 to 1.40). Differences favouring normothermia were found in urea nitrogen at 2 days geometric mean ratio (GMR)=0.86 95% CI (0.77 to 0.97); serum creatinine at 3 days GMR=0.89, 95% CI (0.81 to 0.98); urinary albumin at 48 hours GMR=0.32, 95% CI (0.14 to 0.74) and neutrophil gelatinase-associated lipocalin at 4 hours GMR=0.47, 95% CI (0.22 to 1.02), but not at other postoperative time points.
CONCLUSIONS


Normothermic CPB is as safe and effective as hypothermic CPB and can be routinely adopted as a perfusion strategy in low-risk infants and children undergoing open heart surgery.
TRIAL REGISTRATION NUMBER


ISRCTN93129502.",2019,"There were no significant differences between the treatment groups for any of the co-primary outcomes: inotrope duration HR=1.01, 95% CI (0.72 to 1.41); intubation time HR=1.14, 95% CI (0.86 to 1.51); postoperative hospital stay HR=1.06, 95% CI (0.80 to 1.40).","['200 participants were recruited; 59 to the  Thermic-1  study and 141 to the  Thermic-2  study', 'low-risk paediatric heart surgery', 'paediatric patients undergoing open heart surgery', '98 patients received', 'low-risk infants and children undergoing open heart surgery', 'children with congenital heart disease undergoing open heart surgery']","['hypothermic CPB', 'normothermic versus hypothermic CPB', 'normothermic CPB perfusion', 'Normothermic CPB', 'hypothermic cardiopulmonary bypass', 'normothermic (35°C-36°C) versus hypothermic (28°C) cardiopulmonary bypass (CPB', 'Normothermic', 'normothermic CPB']","['postoperative hospital stay', 'duration of inotropic support, intubation time and postoperative hospital stay', 'serum creatinine', 'neutrophil gelatinase-associated lipocalin', 'urinary albumin', 'urea nitrogen']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery (procedure)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}]","[{'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C1291218', 'cui_str': 'Urea nitrogen (substance)'}]",200.0,0.296587,"There were no significant differences between the treatment groups for any of the co-primary outcomes: inotrope duration HR=1.01, 95% CI (0.72 to 1.41); intubation time HR=1.14, 95% CI (0.86 to 1.51); postoperative hospital stay HR=1.06, 95% CI (0.80 to 1.40).","[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Caputo', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Pike', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baos', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sheehan', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Selway', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Ellis', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Serban', 'Initials': 'S', 'LastName': 'Stoica', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Parry', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Clayton', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Culliford', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Gianni D', 'Initials': 'GD', 'LastName': 'Angelini', 'Affiliation': 'Bristol Heart Institute, University of Bristol, Bristol, UK.'}, {'ForeName': 'Ragini', 'Initials': 'R', 'LastName': 'Pandey', 'Affiliation': 'Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2018-313567']
3593,25573533,Phase I study of olaparib plus gemcitabine in patients with advanced solid tumours and comparison with gemcitabine alone in patients with locally advanced/metastatic pancreatic cancer.,"BACKGROUND


Olaparib (Lynparza) is an oral poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitor that induces synthetic lethality in cancers with homologous recombination defects.
PATIENTS AND METHODS


In this phase I, dose-escalation trial, patients with advanced solid tumours received olaparib (50-200 mg capsules b.i.d.) continuously or intermittently (days 1-14, per 28-day cycle) plus gemcitabine [i.v. 600-800 mg/m(2); days 1, 8, 15, and 22 (cycle 1), days 1, 8, and 15 (subsequent cycles)] to establish the maximum tolerated dose. A separate dose-escalation phase evaluated olaparib in tablet formulation (100 mg o.d./b.i.d.; days 1-14) plus gemcitabine (600 mg/m(2)). In an expansion phase, patients with genetically unselected locally advanced or metastatic pancreatic cancer were randomised 2 : 1 to the tolerated olaparib capsule combination dose or gemcitabine alone (1000 mg/m(2)).
RESULTS


Sixty-six patients were treated [dose-escalation phase, n = 44 (tablet cohort, n = 12); dose-expansion phase, n = 22 (olaparib plus gemcitabine, n = 15; gemcitabine alone, n = 7)]. In the dose-escalation phase, four patients (6%) experienced dose-limiting toxicities (raised alanine aminotransferase, n = 2; neutropenia, n = 1; febrile neutropenia, n = 1). Grade ≥3 adverse events were reported in 38/47 patients (81%) treated with olaparib capsules plus gemcitabine; most common were haematological toxicities (55%). Tolerated combinations were olaparib 100 mg b.i.d. capsule (intermittently, days 1-14) plus gemcitabine 600 mg/m(2) and olaparib 100 mg o.d. tablet (intermittently, days 1-14) plus gemcitabine 600 mg/m(2). There were no differences in efficacy observed during the dose-expansion phase.
CONCLUSIONS


Olaparib 100 mg b.i.d. (intermittent dosing; capsules) plus gemcitabine 600 mg/m(2) is tolerated in advanced solid tumour patients, with no unmanageable/unexpected toxicities. Continuous dosing of olaparib or combination with gemcitabine at doses >600 mg/m(2) was not considered to have an acceptable tolerability profile for further study.
CLINICALTRIALSGOV


NCT00515866.",2015,"There were no differences in efficacy observed during the dose-expansion phase.
","['patients with genetically unselected locally advanced or metastatic pancreatic cancer', 'cancers with homologous recombination defects', 'patients with locally advanced/metastatic pancreatic cancer', 'patients with advanced solid tumours and comparison with', 'patients with advanced solid tumours received']","['olaparib (50-200 mg capsules b.i.d', 'gemcitabine 600 mg/m(2) and olaparib 100 mg o.d', 'gemcitabine', 'olaparib capsules plus gemcitabine', 'gemcitabine alone', 'poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitor', 'olaparib plus gemcitabine', 'Olaparib (Lynparza', 'olaparib or combination with gemcitabine', 'Olaparib', 'tolerated olaparib capsule combination dose or gemcitabine alone']","['efficacy', 'toxicities', 'dose-limiting toxicities (raised alanine aminotransferase, n = 2; neutropenia, n = 1; febrile neutropenia', 'haematological toxicities', 'Grade ≥3 adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4520026', 'cui_str': 'olaparib 100 MG'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032405', 'cui_str': 'Poly(ADPR) Polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3872110', 'cui_str': 'Lynparza'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",66.0,0.0257923,"There were no differences in efficacy observed during the dose-expansion phase.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bendell', 'Affiliation': 'Drug Development Unit, Sarah Cannon Research Institute/Tennessee Oncology, Nashville. Electronic address: jbendell@tnonc.com.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital, Sutton, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hochster', 'Affiliation': 'Yale Cancer Center, Yale School of Medicine, New Haven, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fielding', 'Affiliation': 'Global Medicines Development, AstraZeneca.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Burke', 'Affiliation': 'Clinical Pharmacology, AstraZeneca, Macclesfield, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Burris', 'Affiliation': 'Drug Development Unit, Sarah Cannon Research Institute/Tennessee Oncology, Nashville.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu581']
3594,31996119,A kinematic analysis on the immediate effects of occlusal splints in gait and running body sway patterns.,"Objective : This study aims to determine whether changes in dental occlusion are correlated to body posture during walking and running. Methods : Fifteen healthy subjects were assessed by a prosthodontist and deemed asymptomatic. Analyses of gait and running were performed in three conditions, in random order: a) occlusal splint; b) placebo splint; and c) no splint. The occlusal splint used in this study positioned the mandible in a stable position. Kinematic data was collected using a 3D motion capture system. Results : Changes in dental occlusion induced by occlusal splints did not influence body sway during gait or running. No significant differences were found between any of the test conditions. Conclusion : Occlusal splints have no effect on body sway during gait or running. High inter-subject variability in kinematic parameters was found, which should be considered in future studies.",2022,No significant differences were found between any of the test conditions.,['Fifteen healthy subjects'],"['placebo splint; and c) no splint', 'occlusal splints']",['body sway'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}, {'cui': 'C0162528', 'cui_str': 'Occlusal Splints'}]",[],15.0,0.0525906,No significant differences were found between any of the test conditions.,"[{'ForeName': 'Amândio', 'Initials': 'A', 'LastName': 'Dias', 'Affiliation': 'CIPER - Neuromuscular Research Lab, Faculdade de Motricidade Humana, Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Redinha', 'Affiliation': 'Faculdade de Medicina Dentária, Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Maria João', 'Initials': 'MJ', 'LastName': 'Rodrigues', 'Affiliation': 'Faculdade de Medicina, Universidade De Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Silva', 'Affiliation': 'Kinesiolab, Instituto Piaget, Campus de Almada, Almada, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pezarat-Correia', 'Affiliation': 'CIPER - Neuromuscular Research Lab, Faculdade de Motricidade Humana, Universidade de Lisboa, Lisboa, Portugal.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2020.1721173']
3595,29436397,Impacts of an opioid overdose prevention intervention delivered subsequent to acute care.,"BACKGROUND


Opioid overdose is a major and increasing cause of injury and death. There is an urgent need for interventions to reduce overdose events among high-risk persons.
METHODS


Adults at elevated risk for opioid overdose involving heroin or pharmaceutical opioids who had been cared for in an emergency department (ED) were randomised to overdose education combined with a brief behavioural intervention and take-home naloxone or usual care. Outcomes included: (1) time to first opioid overdose-related event resulting in medical attention or death using competing risks survival analysis; and (2) ED visit and hospitalisation rates, using negative binomial regression and adjusting for time at risk.
RESULTS


During the follow-up period, 24% of the 241 participants had at least one overdose event, 85% had one or more ED visits and 55% had at least one hospitalisation, with no significant differences between intervention and comparison groups. The instantaneous risk of an overdose event was not significantly lower for the intervention group (sub-HR: 0.83; 95% CI 0.49 to 1.40).
DISCUSSION


These null findings may be due in part to the severity of the population in terms of housing insecurity (70% impermanently housed), drug use, unemployment and acute healthcare issues. Given the high overdose and healthcare utilisation rates, more intensive interventions, such as direct referral and provision of housing and opioid agonist treatment medications, may be necessary to have a substantial impact on opioid overdoses for this high-acuity population in acute care settings.
TRIAL REGISTRATION NUMBER


NCT0178830; Results.",2019,"The instantaneous risk of an overdose event was not significantly lower for the intervention group (sub-HR: 0.83; 95% CI 0.49 to 1.40).
",['Adults at elevated risk for opioid overdose involving heroin or pharmaceutical opioids who had been cared for in an emergency department (ED'],"['opioid overdose prevention intervention', 'overdose education combined with a brief behavioural intervention and take-home naloxone or usual care']","['instantaneous risk of an overdose event', 'Outcomes included: (1) time to first opioid overdose-related event resulting in medical attention or death using competing risks survival analysis; and (2) ED visit and hospitalisation rates, using negative binomial regression and adjusting for time at risk']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]",241.0,0.0858826,"The instantaneous risk of an overdose event was not significantly lower for the intervention group (sub-HR: 0.83; 95% CI 0.49 to 1.40).
","[{'ForeName': 'Caleb J', 'Initials': 'CJ', 'LastName': 'Banta-Green', 'Affiliation': 'Alcohol & Drug Abuse Institute and Department of Health Services, School of Public Health University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Phillip O', 'Initials': 'PO', 'LastName': 'Coffin', 'Affiliation': 'Substance Use Research, San Francisco Department of Public Health, San Francisco, California, USA.'}, {'ForeName': 'Joseph O', 'Initials': 'JO', 'LastName': 'Merrill', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Sears', 'Affiliation': 'Department of Health Services, School of Public Health and Harborview Injury Prevention and Research Center, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Dunn', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Floyd', 'Affiliation': 'Alcohol & Drug Abuse Institute and Department of Epidemiology, School of Public Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Whiteside', 'Affiliation': 'Department of Emergency Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Norbert D', 'Initials': 'ND', 'LastName': 'Yanez', 'Affiliation': 'Oregon Health & Science University/Portland State University School of Public Health, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Donovan', 'Affiliation': 'Alcohol & Drug Abuse Institute and Department of Psychiatry & Behavioral Sciences, University of Washington, Seattle, Washington, USA.'}]",Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention,['10.1136/injuryprev-2017-042676']
3596,31577177,Increasing Vegetable Intake by Emphasizing Tasty and Enjoyable Attributes: A Randomized Controlled Multisite Intervention for Taste-Focused Labeling.,"Healthy food labels tout health benefits, yet most people prioritize tastiness in the moment of food choice. In a preregistered intervention, we tested whether taste-focused labels compared with health-focused labels increased vegetable intake at five university dining halls throughout the United States. Across 137,842 diner decisions, 185 days, and 24 vegetable types, taste-focused labels increased vegetable selection by 29% compared with health-focused labels and by 14% compared with basic labels. Vegetable consumption also increased. Supplementary studies further probed the mediators, moderators, and boundaries of these effects. Increased expectations of a positive taste experience mediated the effect of taste-focused labels on vegetable selection. Moderation tests revealed greater effects in settings that served tastier vegetable recipes. Taste-focused labels outperformed labels that merely contained positive words, fancy words, or lists of ingredients. Together, these studies show that emphasizing tasty and enjoyable attributes increases vegetable intake in real-world settings in which vegetables compete with less healthy options.",2019,"Across 137,842 diner decisions, 185 days, and 24 vegetable types, taste-focused labels increased vegetable selection by 29% compared with health-focused labels and by 14% compared with basic labels.",[],['taste-focused labels compared with health-focused labels increased vegetable intake'],"['Increasing Vegetable Intake by Emphasizing Tasty and Enjoyable Attributes', 'Vegetable consumption', 'vegetable selection']",[],"[{'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.229194,"Across 137,842 diner decisions, 185 days, and 24 vegetable types, taste-focused labels increased vegetable selection by 29% compared with health-focused labels and by 14% compared with basic labels.","[{'ForeName': 'Bradley P', 'Initials': 'BP', 'LastName': 'Turnwald', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Jaclyn D', 'Initials': 'JD', 'LastName': 'Bertoldo', 'Affiliation': 'Residential and Dining Enterprises, Stanford University.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Perry', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Policastro', 'Affiliation': 'Institute for Food, Nutrition, and Health, Rutgers University.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Timmons', 'Affiliation': 'Dining Services, Northeastern University.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bosso', 'Affiliation': 'School of Public Policy and Urban Affairs, Northeastern University.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Connors', 'Affiliation': 'Department of Hospitality and Tourism Management, University of North Texas.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Valgenti', 'Affiliation': 'Department of Philosophy, Lebanon Valley College.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Pine', 'Affiliation': 'USC Hospitality, University of Southern California.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Challamel', 'Affiliation': 'Menus of Change University Research Collaborative.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, Stanford University.'}, {'ForeName': 'Alia J', 'Initials': 'AJ', 'LastName': 'Crum', 'Affiliation': 'Department of Psychology, Stanford University.'}]",Psychological science,['10.1177/0956797619872191']
3597,30882751,Single versus Split Dose of Iron Optimizes Hemoglobin Mass Gains at 2106 m Altitude.,"PURPOSE


To determine if a single versus a split equivalent daily dose of elemental iron was superior for hemoglobin mass (Hbmass) gains at altitude while minimizing gastrointestinal (GI) discomfort.
METHODS


Twenty-four elite runners attended a 3.1 ± 0.3 wk training camp (Flagstaff, AZ; 2106 m). A two-group design, randomized and stratified to baseline Hbmass, sex, and ferritin (>30 μ·L), was implemented daily as: 1) single dose of 1 × 200 mg (PM only, SINGLE) versus 2) split dose of 2 × 100 mg (AM and PM; SPLIT) elemental iron (ferrous fumarate). The Hbmass and venipuncture assessments were completed upon arrival and departure (±2 d) from camp for ferritin, hepcidin, and erythroferrone (ERFE) concentrations. Validated food frequency, GI distress, menstrual blood loss (MBL) and training questionnaires were implemented throughout. Univariate analysis was used to compare Hbmass, with baseline ferritin, dietary iron intake, MBL, and training volume used as covariates.
RESULTS


Both conditions increased Hbmass from baseline (P < 0.05), with SINGLE (867.3 ± 47.9 g) significantly higher than SPLIT (828.9 ± 48.9 g) (P = 0.048). The GI scores were worse in SINGLE for weeks 1 and 2 combined (SINGLE, 18.0 ± 6.7 points; SPLIT, 11.3 ± 6.9 points; P = 0.025); however, GI scores improved by week 3, resulting in no between-group differences (P = 0.335). Hepcidin significantly decreased over time (P = 0.043) in SINGLE, with a nonsignificant decrease evident in SPLIT (~22%). ERFE significantly decreased in both groups (~28.5%; P < 0.05). No between-group differences existed for ERFE, hepcidin, food frequency, MBL, or daily training outcomes (P > 0.05).
CONCLUSIONS


A single nightly 200-mg dose of elemental iron was superior to a split dose for optimizing Hbmass changes at altitude in runners over an approximately 3-wk training camp.",2019,"No between-group differences existed for ERFE, hepcidin, food frequency, MBL, or daily training outcomes (P > 0.05).
","['Twenty-four elite runners attended a 3.1 ± 0.3 wk training camp (Flagstaff, AZ; 2106 m']","['single dose of 1 × 200 mg (PM only, SINGLE) versus 2) split dose of 2 × 100 mg (AM and PM; SPLIT) elemental iron (ferrous fumarate']","['hemoglobin mass (Hbmass) gains at altitude while minimizing gastrointestinal (GI) discomfort', 'Validated food frequency, GI distress, menstrual blood loss (MBL) and training questionnaires', 'GI scores', 'ERFE', 'baseline ferritin, dietary iron intake, MBL, and training volume used as covariates', 'ERFE, hepcidin, food frequency, MBL, or daily training outcomes', 'ferritin, hepcidin, and erythroferrone (ERFE) concentrations']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0060276', 'cui_str': 'Ferrous fumarate'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood (substance)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0376520', 'cui_str': 'Dietary Iron'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0612011,"No between-group differences existed for ERFE, hepcidin, food frequency, MBL, or daily training outcomes (P > 0.05).
","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hall', 'Affiliation': 'Canadian Sport Institute Pacific, Vancouver & Victoria, British Columbia, CANADA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Peeling', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), University of Western Australia, Crawley, Western Australia, AUSTRALIA.'}, {'ForeName': 'Elizabeta', 'Initials': 'E', 'LastName': 'Nemeth', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bergland', 'Affiliation': 'Hypo2 High Performance Sport Center, Flagstaff, AZ.'}, {'ForeName': 'Walter T P', 'Initials': 'WTP', 'LastName': 'McCluskey', 'Affiliation': 'Canadian Sport Institute Pacific, Vancouver & Victoria, British Columbia, CANADA.'}, {'ForeName': 'Trent', 'Initials': 'T', 'LastName': 'Stellingwerff', 'Affiliation': 'Canadian Sport Institute Pacific, Vancouver & Victoria, British Columbia, CANADA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000001847']